cyrilzakka/clinical-trials huggingface dataset:
Anthropometric Measures and Severity of Gastroesophageal Reflux Disease

evaluate the impact of different anthropometric measures on clinical and endoscopic severity of GERD and its relation to serum leptin.


Eligibility Criteria:
Inclusion Criteria:

* Gastro esophageal reflux symptoms (e.g. heart burn, regurgitation, water brash or atypical symptoms such as hoarseness of voice, asthma and cough)
* complete upper gastrointestinal endoscopy.

Exclusion Criteria:

* Receiving medication for reflux disease (including proton pump inhibitor, histamine type 2 receptors blocker, prokinetic agents) in the previous month.
* Pregnant woman.
* History of upper abdominal surgery.
* Severe co-morbidity as cirrhosis, end-stage renal disease and heart failure.
Prospective, Long-term Evaluation of the SAPIEN 3 Ultra RESILIA Valve

Evaluation of clinical outcomes and valve performance of the SAPIEN 3 Ultra Resilia (S3UR) valve over 10 years.

Transcatheter aortic valve replacement (TAVR) has become the gold standard treatment for moderate-to-high risk elderly patients with severe symptomatic aortic stenosis. Based on the results of randomized trials including low-risk patients, this treatment has been progressively applied to younger (in the sixties and seventies) patients with a low co-morbidity burden. Life expectancy in this group is expected to extend beyond 5 years from intervention in the vast majority of patients and beyond 10 years in a high proportion. Thus, the issue of valve durability has become one of the most important aspects in the TAVR field in recent years. To date, the rates of bioprosthetic valve failure at 8-10 years after TAVR have been systematically \<10% in all studies, but some studies have shown some degree of valve structural degeneration in close to one-third of the patients at 8-year follow-up . This subclinical valve degeneration before the 10-year follow-up landmark would represent the initial step in the process of bioprosthetic valve failure, and further valve degeneration leading to clinical symptoms is likely to occur in a significant proportion of these cases. Thus, the objective of this stufy is to evaluate the valve hemodynamics of the SAPIEN 3 Ultra RESILIA valve (S3UR) over a long-time period.

Eligibility Criteria:
Inclusion Criteria:

1. Patients with severe aortic stenosis undergoing transfemoral TAVI with S3UR valve
2. Successful implantation of the S3UR valve
3. VARC-3 defined technical succes is defined as:

   * Freedom from mortality
   * Successful access, delivery of the device, and retrieval of the delivery system
   * Correct positioning of a single prosthetic heart valve into the proper anatomical location
   * Freedom from surgery or intervention related to the device ( exluding permanent pacemaker) or to a major vascular or access related, or cardiac structural complication

Exclusion Criteria:

-
Monitoring of Erythroid Lineage Specific Chimerism Following Allogeneic Hematopoietic Transplantation for Thalassemia Major

The purpose of this study is to collect peripheral blood and bone marrow aspirate samples from thalassemia patients in Tehran, in a collaborative effort to develop an erythroid lineage specific chimerism assay applicable to patients with thalassemia. Development of such an assay would be useful both for identification of the exact mutation causing the disease, as well as for providing a direct method to measure and monitor the kinetics of donor erythropoiesis in this patient population following transplant.

* In the first phase of the study we will develop a panel of reagents designed to identify predominant thalassemia mutations in the Iranian population, as well as alternative highly variable erythroid specific polymorphisms. To determine how informative this panel is, these reagents will be applied to samples collected from patients homozygous for the disorder, and compared to patients with thalassemia trait and normal Iranian donors.
* In the second phase, we propose to serially measure and compare erythroid lineage chimerism with overall genomic chimerism following transplant. Samples will be collected from participants before and at 1, 2, 3, 6 and 12 months following transplant and cryopreserved. Peripheral blood from the stem cell donor will also be collected and cryopreserved. Participants will undergo myeloablative or nonmyeloablative transplant.

Eligibility Criteria:
Inclusion Criteria:

* Thalassemia patients being treated at Shariati Hospital in Tehran.
Effectiveness and Safety of Angongniuhuang Pill on Restoring Consciousness for Patients Who Have Suffered From a Stroke

This study will determine if Angongniuhuang Pill (Composed of Niuhuang, Yujin, Xijiao, Huangqin, Huanglian, Xionghuang, Zhizi, Zhusha, Bingpian, Shexiang, and Zhenzhu) will have a better effect in restoring consciousness for patients who have suffered from an acute ischemic stroke. The study is designed to look at both consciousness level and overall recovery and recovery of motor function, for example muscle strength and coordination.


Eligibility Criteria:
Inclusion Criteria:

* Occurrence of an acute ischemic stroke (between 9 and 72 h after onset) with
* A score of not higher than 12 of Glasgow Coma Scale (GCS)
* Patient age of between 18 and 80 years.
* Patients or their representatives voluntarily take part in this study and signed the informed consent

Exclusion Criteria:

* Transient Ischemic attack(TIA), cerebral hemorrhage, subarachnoid hemorrhage
* Ischemic stroke that needs rt-PA treatment
* Subjects who are unlikely to complete taking the investigational product and/or are unlikely to undergo active medical management during that period due to a severe clinical condition.
* Pregnant or breast-feeding.
* Proven disability by law, such as blindness, deafness, dumb, disturbance of intelligence, mental disorders, limb handicap.
* Liable to be allergic (allergic to at lease 2 foods/drugs previously exposed)
* Had been participated in other clinical trials during the last 1 month prior to study inclusion.
Learning Disability Group Art Therapy: Looking and Asking

A qualitative study of group art therapy in England for adults with a learning disability accessing community services. Different stakeholder views and experiences will be gathered using ethnographically-informed group observation, semi-structured individual interviews and a focus group. People with a learning disability will support the data analysis and dissemination of findings in accessible means.


Eligibility Criteria:
INCLUSION CRITERIA:

Participants who are art therapists must:

* Be a HCPC registered arts therapist practicing in the UK
* Have experience of delivering group arts therapy in a community setting to this population
* Be able to give informed consent and communicate in English

Participants who are adults with a learning disability must:

* Be 18 years old or over
* Have a diagnosed learning disability or be accessing an NHS specialist learning disability service or using their personal budget to access a third sector art therapy group for this population
* Have experienced mental distress, have a diagnosed mental health condition or be accessing support for their mental health
* Be currently accessing group arts therapy
* Be able to give informed consent with adapted communication aids and approaches to meet their communication preferences
* Have a level of verbal ability to ensure they can communicate their views and meaningfully engage in the study

Participants who are paid support staff or family carers must:

* Be 18 years old or over
* Be identified by the person with a learning disability as someone who knows them well and could represent the carer perspective in this study
* Be able to give informed consent
* Have adequate command of the English to be able to meaningfully engage in the study

Participants will be excluded if they:

* Are unable to engage in the informed consent process; this is likely to exclude people who have a more severe form of learning disability
* Delivering the arts therapy group on an inpatient or acute ward
* Trainee arts therapists, or those who have yet to complete registration with the HCPC
Effects of Upper Extremity Rehabilitation Using Smart Glove in Stroke Patients

The purpose of this study is to evaluate the therapeutic effects of smart glove which is motion-based program designed for upper extremity rehabilitation after stroke.

This study will evaluate the therapeutic effects (upper extremity power, function and activity of daily living) of smart glove which is motion-based rehabilitation program.

Eligibility Criteria:
Inclusion Criteria:

* CT or MRI proved 1st stroke patients with unilateral hemiplegia caused by stroke (ischemic, hemorrhagic, intracranial hemorrhage)
* 72 hours \~ 3 months after stroke
* Upper extremity hemiplegia with Brunnström stage 2-5.
* The patients can sit to receive treatment for at least 1 hour

Exclusion Criteria:

* The patients cannot perform occupational treatments because of severe hemineglect or hemianopia
* Contracture due to severe limitation of motion
* Upper extremity spasticity in the wrist and fingers with modified Ashworth scale \> 2 points
* Fugl-Meyer Assessment-Wrist \& Hand score \>= 21 points
* moderate to severe cognitive dysfunction \< MMSE 18 points
* Severe aphasia
* The patients who has been diagnosed as malignant tumor
Impact of Air Pollution on the Autonomic Nervous System Activity and the Presence of Sleep Apnea in Older Subjects

Impact of air pollution on the autonomic nervous system activity and presence of sleep apnea in older subjects.

The relation between the air pollution and morbidity, cardiovascular mortality was increasing interest. Analyses show an increase of respiratory difficulty, but also cardiac deaths in the daytime when the atmospheric pollution was increased. It was demonstrated that health effects of ambient air pollution in subjects presenting cardiac or lung difficulty were important. Mechanisms show a possible relation to autonomic nervous system (ANS) deactivation and mortality. Particularly, the ageing and ANS reach would be more predictive of cardiovascular events. Thus, we suggest estimating in 60 healthy volunteers from 60 to 80 years old, the impact of the air pollution on the autonomic nervous system activity and sleep apnea consequences.

Eligibility Criteria:
Inclusion Criteria:

* reside in Lyon and Saint-Etienne cities
* security social affiliated or beneficiary
* information note signed

Exclusion Criteria:

* heart rate disorders
* pacemaker
* tabacco addiction or second-hand smoke
* morbid obesity (BMI \> 30)
* insulin-dependent diabetes
* chronic disease on treatment
* antiarrythmic treatments
Myocardial Injury in Patients With Cardiac Implantable Electronic Devices Following Magnetic Resonance Imaging

Researchers are trying to determine if heart injury occurs in subjects with cardiac implantable electronic device (CIED), such as a pacemaker or implantable cardioverter defibrillator (ICD), who undergo a magnetic resonance imaging (MRI).

With an aging population and growing indications for both MRI and CIEDs, it is estimated that patients with a CIED will have up to a 75% likelihood to meet some indication for MRI during their lifetime. MRI in patients with CIEDs has been increasingly shown to be a viable option in a variety of clinical circumstances under strict protocols and close monitoring. It is uncertain if MRI results in myocardial injury. Injury could occur due to heating of the lead(s) with myocardial heating and injury occurring at the lead tip.

A previous Mayo study published in 2016 showed no significant changes in cardiac troponin levels in the majority of patients with a CIED when MRI was performed. This study however was done using the older, less sensitive troponin assay. Unpublished data from the Mayo ED showed an increase in diagnosis of acute myocardial injury from 39% to 62% after implementation of the new hs-cTnT assay, reflecting its increased sensitivity. The previous Mayo study was also a retrospective study, and thus the data gathered was not as rigorously controlled as might be ideal.

Eligibility Criteria:
Inclusion Criteria:

* Patients who have CIED devices (whether conditional or unconditional, regardless of the type of device e.g. ICD, pacemakers, leadless pacemakers) who undergo MRI for any reason

Exclusion Criteria:

* Patients under age 18
* Patients with myocardial infarction, coronary artery bypass grafting or any invasive cardiac procedure in the previous six weeks
* Pregnant patients
* Patients who cannot provide informed consent because of cognitive dysfunction
Feasibility Study to Evaluate the Use of Patient Reported Complications After Digital Consent

Patient report complication data to our best knowledge has not been studied yet in electronic consent. This study is a feasibility study to assess whether patients will reliably report their complications, the quality of this reporting and whether the information provided in the consent form matches up to their experience. This data will then be used to improve the consent process and evaluate whether the Patient Initiated Follow Up (PIFU) model is effective or if it leads to underreporting of problems.

At the time of consent, patients are informed of possible post-operative complications. It is often not known whether these complications actually occur, whether there are others which go unreported and the extent, both quantitatively and qualitatively, of the complications. Patient reported complication data, to our best knowledge has not been previously studied.

This study is a feasibility study to assess whether patients will reliably report their complications, the quality of this reporting and whether the information provided in the consent form matches up to their experience. In this case, consent is to be sought digitally; the digital consent form includes a procedure specific list of recognised complications but these might not reflect actual patient experience.

If PRC data collection is feasible and reliable, this technique could be scaled to create a consent feedback loop, enabling operative outcome data to be collected from all patients, to be be used to improve the consent process for subsequent patients.

Awareness of post-operative patient complications is important and it is an NHS (National Health Service) requirement that complications are discussed within regular clinical governance (mortality/morbidity) audit departmental meetings. Currently this process relies on clinicians obtaining and reporting these complications. The move towards Patient Initiated Follow Up (PIFU) models may be leading to underreporting of problems. Potentially Patient Reported Complications would allow for a more comprehensive understanding of the benefits and consequences of the various surgical procedures. This in turn might help facilitate 'shared decision making' and allow treatment decisions to be tailored to the individual patients.

Eligibility Criteria:
Inclusion Criteria:

* Consent form 1- Adult patients who have the capacity to consent for themselves.
* Female adult aged 18years or above
* Diagnosed with early invasive breast cancer suitable for breast conserving surgery
* Undergoing Wide Local Excision of the breast and sentinel lymph node biopsy.
* Participant must be able to fill out an electronic questionnaire or take part in a phone questionnaire.
* Participant is willing and able to give informed consent for participation in the study.

Exclusion Criteria:

* Unable to consent for themselves or do not wish to participate.
* Patients who need an interpreter.
Goal-directed MIS Simulation Training With the LTB-Curriculum Prior to First Operations on Patients: Study Protocol for a Multi-centre Randomized Controlled Validation Trial (NOVICE)

Background: Laparoscopic surgical procedures have become increasingly established in operative medicine. They require special motor, haptic, and spatial-visual skills to perform the interventions safely and effectively. These minimally invasive surgery (MIS) basic skills are often learned in the operating room (OR) on the patient. This is economically inefficient and can be improved with regard to patient safety. Against the background of this problem, various simulators and video-box trainer have been developed in order to train laparoscopic basic skills outside the OR. The Lübecker Toolbox (LTB) curriculum is a video-based trainer including standardized and validated exercises with defined targets, based on the skills of experts MIS. Conducting MIS training outside the OR prior to performing the first MIS procedures on patients could be a sensible and valuable contribution to effective surgical education. An evidence of effectiveness in the practice transfer could have a considerable relevance with regard to the integration of MIS training programs into surgical education programs.

Aim of the study: The aim of the study is to investigate whether surgical residents without previous active experience in MIS are able to improve laparoscopic skills in MIS procedures in the OR, if they have successfully completed the LTB curriculum.

In the multicentric prospective study, will be conducted with surgical residents (SR) without prior active experience in MIS (n=14). After the SR have completed their first laparoscopic cholecystectomy (CHE), they will be randomized into two groups: 1) The intervention group will perform the LTB-Curriculum, whereas 2) the control group will not undergo any MIS training. After 6 weeks, both groups will perform the second laparoscopic CHE. Improvements in operative performance (between CHE I and CHE II) will be evaluated according to the Global Operative Assessment of Laparoscopic Skill (GOALS) Score (primary endpoint).


Eligibility Criteria:
Inclusion Criteria:

* no motor or sensory restrictions when using surgical instruments surgical instruments.
* no previous performed MIS simulation training
* no previous performed MIS procedure ( any previous assisted MIS procedures are not an exclusion criterion)
* residents in surgical education for general or visceral surgery in Germany

Exclusion Criteria:

* The participant are not allowed to perform any other MIS training programs during the study period
* Before the start of the study, participants are not allowed to have performed any prior MIS simulation training or any MIS procedure
Progesterone for Maintenance Tocolysis: A Randomized Placebo Controlled Trial

Preterm delivery is the most common cause of infant morbidity and mortality in the United States. Some women have episodes of preterm labor during their pregnancy which can be temporarily stopped. These women, however, are at high risk for delivering before term. At this time, we do not have sufficient evidence to use any medication to help prevent these women from delivering early. Recently, preliminary studies have shown that progesterone may help prevent some women at high risk for preterm delivery from delivering early. Our study will investigate whether progesterone can help this specific group of women, women with arrested preterm labor, deliver healthy infants at term.

The purpose of this study is to test the efficacy of progesterone in prolonging human pregnancies complicated by arrested preterm labor. Animal labor has not been shown to be equivalent to human labor and would not be an appropriate substitute for this study.

In addition, this medication has been previously used in pregnant women without any evidence of significant harm to the mother or fetus. Women will be approached for enrollment in the study during their hospitalization for preterm labor. If they choose to enroll, they will have weekly MD visits at the obstetrical clinic, daily use of vaginal progesterone that will be self administered, and routine obstetric care at the time of recurrent labor and delivery. The daily progesterone is not a part of routine care for these patients. In addition, we will ask patients to fill out a written questionaire one week after starting the medication to describe any subjective symptoms that may be associated with this medication. Finally, we will assess the peripheral levels of progesterone with a blood draw prior to starting the mediation, one week after starting the medication, and at the time of recurrent pre-term labor or delivery. The first two of these blood draws will be in addition to the standard treatment. The final blood draw will involve collecting an extra sample at a time when the participant would normally have blood drawn as a part of routine care.

Eligibility Criteria:
Inclusion Criteria:1. Pregnant women with arrested preterm labor between 24+0 to 33+6 weeks pregnant.

2. Intact membranes 3. Singleton pregnancy 4. Greater than or equal to 18 years of age 5. Cervical dilation less than or equal to 4cm Exclusion Criteria:1. Any contraindication to on-going pregnancy 2. Placental abruption 3. Placenta previa 4. Lethal fetal anomalies 5. Premature rupture of membranes 6. Multiple gestation 7. Less than 18 years old 8. Known allergy to any component of the study medication or placebo 9. Severe maternal medical illness
Amrubicin Study for Elderly Patients With Extensive-disease Small-cell Lung Cancer (ED-SCLC)

The purpose of this study is to compare the efficacy and toxicity of amrubicin with carboplatin plus etoposide in elderly patients with extensive-disease small-cell lung cancer.


Eligibility Criteria:
Inclusion Criteria:

* Extensive-disease small-cell lung cancer
* Aged 70 years or older
* Performance status of 0-2
* No prior chemotherapy

Exclusion Criteria:

* Prior therapy for primary lesion
* Pneumonitis and/or pulmonary fibrosis
* Active concomitant malignancy