cyrilzakka/clinical-trials huggingface dataset:
A Prospective Study to Evaluate the Suture Pattern With the Endomina Suturing Device for Endoscopic Sutured Gastroplasty (ESG).

Advances in endoluminal devices are now allowing clinicians the ability to begin exploring bariatric procedures performed via flexible endoscopy. Although these procedures may not be as effective as their surgical counterparts, these less-invasive options may relieve patients of the significant risks associated with surgery (1).

Endomina (Endo Tools Therapeutics, Gosselies, Belgium) is CE mark device that may be attached to an endoscope inside the body and allows remote manipulation of the arms of the device during a peroral intervention. It offers the possibilities of making transoral surgical full thickness sutures and may allow performing endoscopic therapeutic interventions, via a transoral route.

A first trial including 11 patients assessed feasibility and safety of the technique (2). There were no complications and the short-term results were encouraging. Then a multicentric efficacy study was conducted, including 51 patients (3). The results where EWL of 31% at one year and TBWL of 9% without complications.

Finally a randomized controlled study was done including 73 patients in a 2/1 randomized fashion with a crossover at 6 months. Treated group was with the endomina device and controlled group was diet only. The follow-up was the same in each group. Primary endpoint was to reach the ASGE guideline "difference between a control group and a treatment group of minimum 15%" (4).

Technique and suture pattern have evolved since the first study. The aim of this prospective evaluation is to compare different suture patterns and their mechanism of action.


Eligibility Criteria:
Inclusion Criteria:

1. Age between 18-64 years;
2. BMI between 30 to 40 kg/m²
3. Must be able to comply with all study requirements for the duration of the study as outlined in the protocol. This includes complying with the visit schedule as well as study specific procedures such as: clinical assessment, endoscopy, radiography, gastric emptying scintigraphy, satiety test, as well as laboratory investigations.
4. Must be able to understand and be willing to provide written informed consent.
5. Must have completed the multidisciplinary workup

Exclusion Criteria:

1. Achalasia and any other esophageal motility disorders
2. Heart diseases: unstable angina, myocardial infarction within the past year, or heart disease classified within the New York Heart Association's Class III or IV functional capacity.
3. Hypertension: uncontrolled hypertension during last 3 month
4. Severe renal, hepatic, pulmonary disease or cancer;
5. GI stenosis or obstruction
6. Pregnancy or breastfeeding or willing to become pregnant within study duration
7. History of gastric surgery (any type)
8. Impending gastric surgery 60 days post intervention
9. History of weight changes (±5% TBWL) within the previous 6 months
10. Placement/removal of an intragastric balloon in less than 6 months
11. Currently participating in other study
12. HP positive
Balance, Activity and Quality of Life

Background: Advanced cancer may cause functional limitations, subsequently leading to decreased ability to perform and engage in everyday activities, such as self-care, household, leisure and civic life. In addition, people with advanced cancer need alleviation from the pain and sorrow following limited life expectancy wherefore they prefer to focus on everyday life function and activities, lightness and enjoyment. The overall aim of the Balance, Activity and quality of Life (BAL) project is to develop, test and evaluate effectiveness and process of a resource-oriented intervention which coordinates rehabilitation and palliative care to enhance quality of life (QoL), balance and enjoyment in everyday activities and functioning. The development of the intervention is guided by the British Medical Research Council's guidance (MRC).

The present study consists of a resource-oriented intervention, which will be feasibility tested in the research clinic of REHPA, the Danish Knowledge Centre for Rehabilitation and Palliative Care. The study will inform the development of a resource-oriented program for people with advanced cancer.

Material and Methods: A feasibility study designed as a one-armed, pre-post study with follow-up after five days and again after 6 and 12 weeks. The study will recruit 20-25 home-living adults (⩾18 years) with chronic or advanced cancer reporting needs in everyday life.

Outcomes are quality of life, physical function and fatigue assessed using the European Organisation for Research and Treatment of Cancer Quality-of-Life Questionnaire Core 30 (EORTC QLQ C-30). Furthermore, balance in everyday activities will be assessed using the Occupational Balance Questionnaire 11 (OBQ-11).

Besides outcomes, process data will also be collected regarding: 1) fidelity, 2) adherence, 3) dose and 4) reach and mechanisms of impact with attention to participant's experiences of and interactions with the intervention. These data will be collected using registration forms, questionnaires, participant-observations and focus-group interviews.


Eligibility Criteria:
Inclusion Criteria:

* Home-living adults
* Diagnosed with chronic or advanced cancer
* Report a need of support in everyday life and to better balance everyday life with necessary and meaningful activities
* Motivated and able to participate in the intervention
* Know sufficient Danish to complete questionnaires and participate in interviews

Exclusion Criteria:

* Dependent in basic activities of daily living (personal care, dressing and eating)
* Not able to complete questionnaires and participate in interviews
* Severe cognitive deficits
Effects of Oxytocin on Emotion Recognition and Response Inhibition

The purpose of this study is to shed light on the basic neurobiological mechanisms which underlie social information processing in healthy men. More specifically, we intend to examine whether a person's social competence level is related to the patterns of neural activity and his visual search strategies during evaluation of social scenes. Furthermore, it will be assessed whether an oxytocin-driven increase in activity in brain areas relevant to the task will facilitate social information processing and thus enhance task performance. Additionally it will be examined whether oxytocin can facilitate response inhibition in an emotional context.


Eligibility Criteria:
Inclusion Criteria:

* MRI- eligibility
* Subject's ability to fully grasp the type, scope and individual consequences of the study
* Willingness to participate in and comply with the study procedures as indicated by signing the dated informed consent form

Exclusion Criteria:

* Left-handedness
* Smoking
* Regular intake of medication
* Hypersensitivity towards oxytocin or a chemically similar substance
* Current or previous neurological or psychiatric disorder
* Nose surgery or chronic sinus infection
* Any somatic disorder that may interfere with the experimental procedures, affect the outcome measures or pose a risk for the participant during performance of the experiment
Nitrous Oxide Frequency of Use and Causes in Hospital in Turkey

The prevalence of nitrous oxide use in hospitals in Turkey

Nitrous oxide has a long history of use in the healthcare field for over 150 years. However, this gas is slowly being abandoned for various reasons. The decrease in N2O use is probably due to its side effects and negative impact on global warming. Proven side effects include irreversible toxic effects on bone marrow, relative or absolute contraindications related to neuro and cardiac anesthesia, increased incidence of post-operative nausea and vomiting, increased risk of miscarriage in pregnant women (5), the greenhouse effect of nitrous oxide. In 2013, B. Husum et al. investigated the frequency of N2O use in public hospitals in Scandinavian countries and it was confirmed that N2O use was reduced and limited. According to the results of this research, N2O was administered with a volatile anesthetic agent in 21.5% of general anesthesia applications in Scandinavian countries. N2O was used as the second agent in Denmark by 2.4%, Finland by 17%, Iceland by 34.5, Norway by 32.1%, Sweden by 27.5%. In Turkey there are not enough reports of N2O use prevalence. In this study, we will investigate the extent of use and avoidance reasons N2O in Turkey. And we aim creating awareness.

Eligibility Criteria:
Inclusion Criteria:

Hospitals who accept to participate in Turkey

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Exclusion Criteria:

Hospitals refusing to participate in the study
Measuring the Spectrum of Tissues During Endoscopy

Lesions, polyps and other abnormalities in the gastrointestinal (GI) tract have a different composition compared to the normal mucose. The investigators plan to gather spectroscopic information from these features. Characterizing their unique spectrums, may help to enhance the detection and identification of these objects during endoscopy.


Eligibility Criteria:
Inclusion Criteria:

* Adult, independent patients who come to Sheba Hospital's gastro-intestinal clinic for endoscopy and are willing to sign an informed consent

Exclusion Criteria:

* None
Navigating Pregnancy and Parenthood With Lyme Disease

This is a mixed methods study exploring the experiences of pregnancy and parenting among participants with Lyme disease. Eligible participants will have been diagnosed with Lyme disease (LD), post-treatment Lyme disease syndrome (PTLDS), and/or chronic Lyme (CL) either during or before a prior pregnancy. Participants will complete quantitative surveys on topics such as their medical history, their child(ren)'s development, and demographic information. They will then participate in a qualitative interview where they will be asked about their experiences with pregnancy and with parenting their child(ren) in the context of their condition.

Patients with chronic conditions may experience the perinatal period and the experience of parenting differently than their healthy peers. The purpose of this study is to understand the lived experiences of pregnancy and parenting among gestational parents with Lyme disease.

Participants may be included in this study if they report having received a diagnosis of Lyme disease (LD), post-treatment Lyme disease syndrome (PTLDS), or chronic Lyme (CL) and they have given birth to at least one liveborn child. The investigators hypothesize that patients with LD/PTLDS/CL will experience unique challenges related to pregnancy, experiences in medical care settings, and their child's development.

Enrolled participants will complete a brief set of online quantitative questionnaires on topics such as their demographic characteristics, family information, Lyme disease histories, and mental health. The investigators will report on these data to illustrate similarities and differences between participants in the study for potentially relevant factors (e.g., timing of Lyme diagnosis relative to pregnancy, symptoms, mental health concerns). The questionnaires will be followed by an in-depth qualitative interview in English with each participant to learn about their experiences related to pregnancy and parenting with LD/PTLDS/CL, including specific questions about navigating the health care system, information seeking behaviors, and their child's development.

Eligibility Criteria:
Inclusion Criteria:

* Over 18 years of age and reside in the United States or Canada
* Diagnosed with acute Lyme disease, PTLDS, and/or Chronic Lyme by a health care provider while they were pregnant OR PTLDS/CL prior to becoming pregnant with ongoing symptoms during pregnancy

Exclusion Criteria:

* Under 18 years of age
* Live outside of the United States or Canada
* Never been diagnosed with Lyme disease by a medical provider
* Never been pregnant
* Never given birth to a liveborn infant
* Previously participated in a qualitative study about their experience with Lyme disease
* Do not want to agree to having their interviews audio recorded
Fever After Tick Bite Study

The proposed study is a collaboration between Microbiology, SU/Sahlgrenska and the Infectious Diseases clinic at SU/Östra as well as several Infectious Diseases clinics throughout Sweden aiming at improving microbiological diagnostic assays regarding the early identification of tick-borne microorganisms (including as of yet unidentified pathogens) capable of causing human disease using modern diagnostic tools.

At the initial study visit (day 0) plasma, serum, urine, saliva, and PBMCs (and tick, if available) will be collected from patients developing fever within two weeks after a tick bite. Additional follow-up samples will be obtained after 9 and 30 days as well as after 6 months. The initial samples will be analyzed using (a) directed multiplex PCR analysis for Tick-Borne Encephalitis (TBE), Borrelia, Anaplasma, Neoerlichia, Rickettsia, Coxiella, Tularemia, and Babesiosis in plasma, whole blood and urine, (b) conventional IgM and IgG serology for TBE, (c) "Next Generation Sequencing" (NGS) for the detection of bacterial 16s rRNA as well as unknown viruses, (d) potential biomarkers, and (e) host genetic factors. Among patients where initial sampling indicates the presence of a potential pathogen or in patients developing neurological symptoms, a lumbar puncture will be performed and CSF will be further analyzed. Samples will also be evaluated regarding potential microbiological factors predisposing for severity of infection.

The primary objective of the study is to improve diagnostic tools in the initial early phase of infections caused by tick-borne pathogens, especially TBE prior to the affliction of the central nervous system, and to attempt to identify which factors impact the course of infection as it is believed that approximately 75% of infected individuals resolve their infection in this first phase whereas others develop meningoencephalitis with significant subsequent neurological sequelae. Secondary objectives of the study include investigating for the presence of and treating other tick-borne pathogens, setting the stage for coming clinical trials evaluating novel anti-viral therapies for TBE.


Eligibility Criteria:
Inclusion Criteria:

* Written informed consent
* Male and female patients ≥18 years of age
* Medical history of tick bite within past 2 weeks
* Documented or medical history of fever (≥38°C) within past 2 weeks

Exclusion Criteria:

* Inability or unwillingness to provide informed consent or abide by the requirements of the study
* Presence of urinary tract symptoms
* Presence of non-tick related, infectious agent causing fever, e.g. a respiratory virus
* Presence of other medical, non-infectious cause of fever
Adaptive Radiotherapy for Head and Neck Cancer

The purpose of this study is to demonstrate that adaptive radiotherapy (ART) in head and neck cancer patients are comparable to historical controls in head and neck patients undergoing standard intensity-modulated radiation therapy (IMRT) without ART.


Eligibility Criteria:
Inclusion Criteria:

* Participants with pathologically confirmed cancers of paranasal sinuses, oropharynx, oral cavity, nasopharynx, larynx, hypopharynx, and unknown primary and will receive definitive radiation therapy with or without chemotherapy.
* Karnofsky performance status \>= 70%
* Women of childbearing potential need to have a negative serum pregnancy test at the time of therapy
* Participants must have the ability to understand and the willingness to sign a written consent form

Exclusion Criteria:

* Female participants who are pregnant or breast feeding
* Participants who are not able to comply with study and/or follow up procedures
* Participants who have received induction chemotherapy before radiation treatment
* Participants who had prior head and neck radiation therapy
* Participants who are enrolled in a national/international cooperative group trials
* Patients with metastatic disease
The Study of KAP on Drink Driving in Jiangsu Province in China

Conduct a KAP survey before and after intervention and describe the current knowledge, attitudes and behaviors on drink driving in public and analyse the influential factors to provide rational strategies to enhance the awareness on drink driving in public.


Eligibility Criteria:
Inclusion Criteria:

* aged 18-70, resident for more than 6 months.

Exclusion Criteria:

* less than 18 or older than 70, or provisional resident.
MI With Text Messaging to Reduce Sexual Risk and Hazardous Drinking Among MSM

This is a small pilot study to provide effect size estimates for a brief intervention designed to reduce hazardous drinking and sexual risk behavior among men who have sex with men. The intervention consists of an "in-person" brief motivational intervention followed by a series of text messages related to alcohol and sexual risk reduction. The primary outcome is heavy drinking episodes and frequency of condomless anal intercourse at 3 months.

This is a pilot study designed to provide initial effect size estimates for an intervention addressing hazardous drinking and sexual risk behavior among men who have sex with men. In this study, 24 participants initially recruited through advertisements in the community will be randomly assigned to either Assessment Only or Intervention Condition. Those in the Assessment Only condition will complete baseline, 6-week, 3-month and 6-month assessments. Those in the intervention condition will receive a 50-min brief intervention in person followed by 6 weeks of tailored app-based messaging to support the intervention content, then another 6-weeks of goal setting text-based messages. Data will be analyzed to determine effect sizes of the intervention on key alcohol use and sex risk outcomes. The primary outcome will be 3-month outcomes, controlling for corresponding baseline outcomes.

Eligibility Criteria:
Inclusion Criteria:

* At least 1 heavy drinking episode or consumption of more than 14 drinks per week over the past month
* At least 1 condomless anal sex episode in past 3 months
* Score of 3 or greater on the Kinsey Scale (Kinsey et al., 1948) indicating at least "equally heterosexual and homosexual". Scale ranges from 0 (exclusively heterosexual) to 6 (exclusively homosexual)

Exclusion Criteria:

* Alcohol treatment currently or in past 3 years
* Bipolar disorder or schizophrenia treatment
* Exclusive monogamous relationship
Efficacy and Compliance of the Mandibular Advancement Devices ONIRIS® vs. Custom Made Devices

To evaluate the efficacy (non-inferiority) in terms of response between patients using custom fitted mandibular advancement devices ONIRIS® and patient using laboratory custom made devices TALI, after 2 months of use. Sleeping tests were performed.

Open, non-inferiority, controlled and rndomised clinical trial. Six months of inclusion. Each included patient will be followed during 12 months.

Eligibility Criteria:
Inclusion Criteria:

* patients with severe syndrome of obstructive sleep apnea and hypopneas refusing or withdrawal from continuous positive pression ventilation
* no dental, paro-dental or articular contraindication
* patients never treated by mandibular advancement devices

Exclusion Criteria:

* severe psychiatric or neuromuscular disorders appreciated by the investigator
* more than 20% of apneas and central hypoapneas
* severe syndrome of obstructive sleep apnea and hypopneas with IAH \> 30% associated with another sleeping pathology
* BMI \> 30kg/m2
* patient with an uncontrollable nausea reflex
* epileptic patients
* pregnant patients
* patient without written informed consent
Improving the Humoral Response to Influenza Vaccine in Lung Transplant Recipients by an Intradermal Strategy

The purpose of this study is to test the specific humoral response after an intramuscular and intradermal influenza vaccination in lung transplant recipients

Influenza virus is an important cause of morbidity in the lung transplant population and can lead to viral and bacterial pneumonia and contribute to the bronchiolitis obliterans syndrome. Although the annual influenza vaccine is recommended for lung transplant patients, studies have shown that a single intramuscular (i.m.) dose has poor immunogenicity. There are no studies that define the effect of intradermal doses in this population. We plan to study the immunogenicity of a two-dose regimen of influenza vaccine in 50 lung transplant patients during the 2006-2007 season. After the initial i.m. injection, a second dose will be given intradermally 4 weeks later. Antibody titers will be evaluated by a standard hemagglutination inhibition assay. We hypothesize that the second dose intradermally will significantly increase the proportion of vaccine responders.

Eligibility Criteria:
Inclusion Criteria:

* Lung transplant recipients greater than 3 months post-transplant

Exclusion Criteria:

* · Egg allergy

  * Previous life-threatening reaction to influenza vaccine (ie Guillain Barre Syndrome)
  * On anticoagulants such as warfarin that precludes intramuscular injection
  * Ongoing therapy for rejection
  * Febrile illness in the past two weeks
  * Unable to provide informed consent
The Use of Thoraco-lumbo-sacral Orthoses (TLSOs) in the Treatment of Adolescent Idiopathic Scoliosis (AIS)

The purpose of this study is to compare the risk of curve progression in Adolescent Idiopathic Scoliosis for subjects treated with bracing as compared to those without bracing.


Eligibility Criteria:
Inclusion Criteria:

* Confirmed Diagnosis of AIS
* Age ≥10, ≤15 years old
* Risser 0, 1 or 2
* Primary Cobb angle between 20 and 40 degrees (inclusive)
* Apex (of at least one of the primary curves) caudal to T7
* Pre-menarchal OR post-menarchal by ≤1 year
* Physical and mental ability to adhere to bracing protocol

Exclusion Criteria:

* Diagnosis of other musculoskeletal or developmental illnesses possibly responsible for the curvature
* A history of previous surgical or orthotic treatment
* Inability to read and understand Chinese
Amtolmetin Gaucil in Knee Osteoarthritis

This study is conducted to study the efficacy and safety of Niselat in patients with osteoarthritis.

Osteoarthritis is the most common rheumatic disease. Knee OA (KOA), gonarthrosis (GA), is characterized by high prevalence, progressive course with early disability of the subject, persistent pain syndrome for the treatment of which non-steroidal anti inflammatory drugs (NSAIDs) are actively used in clinical practice. It was revealed that NSAIDs may cause gastrointestinal adverse effects (AEs), from mild dyspepsia to bleeding and perforation as well as cardiovascular effects. Gastroprotection with misoprosol, Н2-receptor antagonists and proton pump inhibitors (PPI) is not always effective. NSAIDs with the lowest gastrointestinal toxicity with efficacy adequate to suppress joint pain is justified and reasonable.

Amtolmetin guacil (AMG) is a new NSAID which proved to be the least gastrointestinally toxic in experimental studies in vivo, in vitro and in comparative clinical studies. AMG does not have selectivity towards COX-2 or NO. AMG exerts gastroprotective effect due to stimulation of capsaicin receptors (vanilloid receptors) in gastrointestinal wall. To assess tolerability of amtolmetin guacil, it is first necessary to obtain data on potential reduction of dyspeptic symptoms including in subjects with these signs of NSAIDs intolerability.

Eligibility Criteria:
Inclusion Criteria:

1. Informed consent form for participation in the study;
2. KOA (based on ACR, 1987)
3. Age between 30-60 years old
4. Previous regular administration of NSAIDs for at least 4 weeks (at maximum therapeutic dose)
5. Dyspeptic symptoms (according to SODA questionnaire)
6. Pain intensity in the investigated knee joint ≥ 40 mm according to VAS
7. Subjects with systolic blood pressure ≤ 140 mm Hg and diastolic BP ≤90 mmHg against stable antihypertensive therapy.

Exclusion Criteria:

1. Contraindications to amtolmetin guacil (according to patient information leaflet)
2. Subjects with SBP ≥140 mm Hg and DBP ≥90 mm Hg
3. Signs of renal or hepatic failure;
4. Pregnancy, lactation or planning for pregnancy.
5. One of the following changes in laboratory values at screening HGB, WBC, ESR, ALT, AST.