cyrilzakka/clinical-trials huggingface dataset:
Clinical and Health Economic Impact of Robot-assisted Surgery vs Conventional Laparoscopy : the Case of Gastric Bypass

The purpose of this study is to gather clinical and economic evidence on the use of robotics for bariatric surgery (gastric bypass).

This monocentric, randomized, single blind, controlled study will evaluate post-operative pain, quality of life and appetite, post-operative complication incidence. It will also provide information on direct and indirect costs of surgery.

Robot-assisted Surgery Versus Conventional Laparoscopy in Bariatric Surgery (Gastric Bypass): a prospective, single-blind, randomized, non-inferiority, and controlled study The main evaluation criterion is 24h post-operative pain assessed using visual analog scale (VAS). Secondary criteria included for clinical assessment: post 24h pain, excess weight loss, quality of life, appetite, complications, conversion rate; and for health-economics assessment : duration of surgical steps, length of stay, return to normal activity and their conversion to cost, consumables, estimation of indirect costs and benefits (e.g., robotics perception, publication).

In this study, main inclusion criteria include major obesity (IMC ≥ 35) with co-morbidities or morbid obesity (IMC ≥ 40), scheduled gastric bypass surgery Main contraindications are previous bariatric surgery and previous major abdominal surgeries To test robotic-assisted surgery non-inferiority on VAS pain score 24h post-surgery, a total of 128 patients (64 per arm) is to be included (alpha 2,5%; power 90%; drop-out rate: 5%).

The study will include 12 months of follow-up post-surgery for each patient. The total study duration is 2 years and 3 months.

Eligibility Criteria:
Inclusion Criteria:

* Patient presenting with major obesity (BMI ≥ 35) with co-morbidities or morbid obesity (BMI ≥ 40)according to French HAS (Haute Autorité de Santé) and CNAMTS (Caisse nationale de l'assurance maladie des travailleurs salariés)criteria for whom gastric bypass is scheduled
* Male or female between 18 and 65 years old
* Patient registered with the French Social Security
* Patient having provided a written informed consent prior to enrolment
* Patient accepting to attend follow-up visits as required by study protocol

Exclusion Criteria:

* Patient with a BMI ≥ 60
* Patient with a contraindication for laparoscopic gastric bypass with or without robotic assistance
* Patient having had prior bariatric surgery
* Patient having had prior major abdominal surgery
* Patient in exclusion period of another clinical study
* Patient pregnant or breastfeeding
* Patient without sufficient knowledge of french language or unable to receive or understand study related information and answer to questionnaires
* Patient with no or limited legal capacity
Effect of Education and Tele-consultancy Intervention Based on Watson Human Care Theory Individuals With COPD

This study aims to investigate the effect of education and tele-consultancy intervention based on Watson's Human Care Theory on self-efficacy and quality of life of individuals with COPD.

: The research that a single-blinded randomized controlled trial, a total of 74 individuals, including 37 individual intervention and 37 individual control groups who applied to Akdeniz University Chest Diseases Polyclinic for consultation and follow-up, meeting the inclusion criteria, conducted between October 2020 - May 2022. In collecting data Information Form Based on Watson Human Care Theory, the Chronic Obstructive Pulmonary Disease Self-efficacy Scale, St. George Quality of Life Scale, and Pulmonary Function Test Form were used. Individuals in the intervention group were provided with training and consultancy based on Watson Human Care Theory, and an educational booklet prepared with current guides and expert opinions. Telephone counseling was provided in the 2nd, 4th, 6th, 8th, and 10th weeks after the first intervention in the intervention group. Routine follow-up of individuals in the control group was continued. The data of the scales in the intervention and control groups are collected in the 12th week. The individuals in the control group were given a training booklet at the end of the study. Statistical analysis of the data was done with SPSS 22.0 software package.

Eligibility Criteria:
Inclusion Criteria:

* Who has been diagnosed with COPD for more than 6 months
* No exacerbation for at least 4 weeks, stable period
* Followed up at Akdeniz University Hospital Chest Diseases Polyclinic
* Clear conscious (evaluated by Sandartize Mini-Mental Test higher than 23 points)
* No verbal communication barriers
* Individual phone owner
* No hearing or communication problems on the phone
* 18 years and older
* Literate
* Agree to participate in the research

Exclusion Criteria:

* Not getting enough points from the Standardized Mini-Mental Test
* A diagnosis of malignancy (based on file information)
Chest Physiotherapy After Bariatric Aurgery - A Comparison Between Incentive Spirometry and Expiratory Positive Airway Pressure (Epap)

Objective: To compare the effects of the EPAP and the incentive spirometry flow-oriented in the pulmonary function after bariatric surgery.

Method: Twenty-eight women, non-smokers, with no lung disease and BMI of 35-49,99 kg/m2, undergoing bariatric surgery by laparoscopy, were studied. Before surgery the patients were divided in two groups: Spirometer Group (SG) (n=13) and EPAP Group (EG) (n=15). Pulmonary function was evaluated by spirometry, thoracoabdominal (cirtometry) and diaphragmatic motion, on the preoperative and on the second postoperative day. Physiotherapy started on the day of surgery, each modality (incentive spirometry or EPAP) performed lasting 15 minutes. The deambulation and active exercises of upper and lower limbs were standardized for groups.


Eligibility Criteria:
Inclusion Criteria:

* Obese with body mass index between: 35 e 50 kg/m2
* Non-smokers
* No lung disease

Exclusion Criteria:

* Unable to perform the evaluation tests
* Not signed the consentment term
Cognition and Motor Learning Post-stroke

This project seeks to determine how post-stroke cognitive impairment moderates motor learning during walking in older adults with chronic stroke and identify brain structural markers that mediate this relationship. The chosen experimental design integrates biomechanical analyses, neuropsychological assessments, and brain imaging techniques to determine the impact of post-stroke cognitive impairment severity on two forms of motor learning (explicit and implicit) and examine the role of the dorsolateral prefrontal cortex in the relationship between cognition and explicit motor learning. Ultimately, this work may lead to the development of a more comprehensive, effective treatment approach to improve walking dysfunction in older adults post-stroke.


Eligibility Criteria:
Inclusion Criteria:

* Unilateral stroke
* Stroke occurred more than 6 months prior
* Paresis confined to one side
* Independently ambulatory (including the use of assistive devices)
* Able to walk for 5 minutes without stopping
* Answers no to all general health questions on the PAR-Q+
* Willingness to complete study procedures

Exclusion Criteria:

* Brainstem or cerebellar stroke
* Aphasia (expressive, receptive, or global)
* Any major musculoskeletal or non-stroke neurological condition that interferes with the assessment of sensorimotor or cognitive function
* Metal in the head (except in the mouth), implanted cranial or thoracic devices that violate MRI safety regulations
* Uncontrolled hypertension (\>160/110mmHg)
* Concurrent physical therapy
* Claustrophobia
* Significant cognitive deficit or dementia (\<20 on MoCA)
* Inability to give informed consent
Pilot Project of Adaptive Thoracic Radiotherapy for Small Cell Lung Cancer

This study is intended to assess the feasibility of adjusting a radiation plan during its course to accommodate for a shrinking tumor target. The investigators hypothesize that an adaptive radiotherapy (RT) planning strategy for small cell lung cancer (SCLC) patients with chest-confined disease will allow for safe delivery of higher doses of chest RT than a non-adaptive RT planning approach without subjecting normal critical structures to unacceptable doses of radiotherapy.


Eligibility Criteria:
Inclusion Criteria:

* patients with histologically or cytologically proven newly diagnosed small cell lung cancer
* chest-confined disease (including bulky intrathoracic disease)
* adequate pulmonary function tests (FEV-1\>1.0 L, DLCO\>50%)
* patients of childbearing potential must practice adequate contraception
* Age \> or = 18 years
* Karnofsky performance status \> or = 70
* eligible for concurrent chemoradiotherapy

Exclusion Criteria:

* patients who have undergone complete or subtotal tumour resection
* evidence of non-small cell histology
* prior or concurrent malignancy except non-melanomatous skin cancer unless disease-free for at least 5 years
* prior RT to the thorax or neck
* compromised lung function with inadequate pulmonary function tests (FEV-1\<1.0,DLCO\<50%)
* pregnant women
Adjusting to Chronic Conditions Using Education, Support, and Skills

The current study seeks to test the effectiveness of a talk-therapy intervention designed to better meet the needs of chronically ill Veterans. This project looks to recruit 450 Veterans with either chronic obstructive pulmonary disease (COPD) or heart failure (HF) who also have symptoms of worry, stress, anxiety, or sadness. Participants will be randomly put into either the talk-therapy intervention or enhanced usual care.

The talk therapy intervention will be provided by VA clinicians in the primary care setting and will consist of 6 core meetings (30-45 minutes in duration) and 2 follow-up telephone meetings. Enhanced usual care participants will receive feedback regarding the assessment findings and educational materials on COPD and/or HF, depression and anxiety.

Diseases of the heart and circulatory system, namely, Chronic Obstructive Pulmonary Disease (COPD) and Heart Failure (HF), are two of the most common and disabling chronic diseases. Both COPD and HF account for significant disability, mortality, and healthcare costs and are associated with lower health status and more functional and social limitations than other chronic illnesses, such as hypertension and diabetes. As our population ages and life span increases, the numbers of patients with these conditions and the subsequent healthcare costs will increase dramatically.

The symptoms associated with COPD and HF can significantly affect daily functioning. Physical symptoms are often linked to increased levels of psychological distress, namely, anxiety and depression, which significantly affect quality of life and functioning above and beyond the impact of the medical disease. As depression and anxiety are modifiable clinical factors, there is a potential to significantly alter patient outcomes, as well as use of healthcare services. However, focused interventions are needed, given the high risk for poor mental health treatment and underuse of mental health services in persons with COPD and HF. Unfortunately, few intervention studies have been conducted in medically ill patients with these conditions. The current project will examine whether existing VA clinicians in the primary care setting, with training and support, can effectively administer a structured Cognitive Behavioral Therapy (CBT) intervention for depressed and anxious Veterans with COPD and HF.

Eligibility Criteria:
Inclusion Criteria:

* COPD and/or HF diagnosis; confirmation based upon medical chart review.
* clinically significant symptoms for anxiety and/or depression.

Exclusion Criteria:

* cognitive impairment
* presence of bipolar, psychotic or substance abuse disorder.
Technology Platform and System Construction of Clinical Evaluation Studies on New Drugs of Hematological Malignancy

Multiple Myeloma (MM) is the second diagnosed malignancy of hematological malignancies. The previous study pointed out that the dosage and course of Bortezomib including the dose of concomitant drugs used to treatment MM patients did not get the preferred treatment program, so we are going to determine the optimal doses and course of Bortezomib through the prospective, multicenter clinical trial and evaluate the efficiency and safety of different program.


Eligibility Criteria:
Inclusion Criteria:

1. Obtain informed consent form (ICF) signed by patients or its relative.
2. Patients newly diagnosed multiple myeloma (MM). (Not include patients with multiple solitary extramedullary plasmacytoma and those atⅠstage of Durie-Salmon staging system)
3. Measurable serum protein:

   IgG type of MM: serum M-protein≥ 1.0g/dl or urine M-protein≥ 200mg/24h. IgA type of MM: serum M-protein≥0.5g/dl or urine M-protein≥200mg/24h. IgM type of MM: (IgM M-protein and osteolytic lesion showed in X-ray):serum protein≥ 1.0g/dl or urine M-protein≥ 200mg/24h. IgD type of MM: serum M-protein≥0.05g/dl or urine M-protein≥200mg/24h. Light chain type of MM: serum M-protein≥ 1.0g/dl or urine M-protein≥ 200mg/24h.
4. Physical score 0\~2 grade(WHO standard), and able to comply with the visit time and protocol requirements.

Exclusion Criteria:

1. Diagnosed with relapsed multiple myeloma.
2. Any serious diseases which may lead patients suffer from unaccepted risk.
3. Female patients who is pregnant or breast-feeding.
4. Histories of other malignant tumors other than MM, except those patients whose disease have been cured for at least 3 years. Exception: basal-cell carcinoma, squamous cell carcinoma, carcinoma in situ of uterine cervix, breast carcinoma in situ,occasionally prostatic cancer histological discovery(at stage T1a or T1B defined as TNM classification).
5. Not be able to understand or comply with the investigate protocol.
6. Patients with grade 2 or higher peripheral neuropathy before treatment.
Compare the Efficacy of VItrectomy Combined With DExamethasone Implant Versus With Aflibercept in DME Patients Diagnosed by Intraoperative OCT (the VIDEO Study): Study Protocol for a Randomized Controlled Trial

Diabetic macular edema (DME) is the main cause of severe vision loss in diabetic retinopathy. Intravitreal injection of anti-vascular endothelial growth factor (VEGF) and Ozurdex are two safe and effective ways to treat DME. Pars plana vitrectomy is mainly suitable for the treatment of unabsorbed vitreous hemorrhage (VH) and tractional retinal detachment caused by proliferative diabetic retinopathy (PDR). Intraoperative optical coherence tomography (OCT), a diagnostic device, can be used to evaluate the potential condition of the retina. Many patients with PDR have unclear refractive stroma due to VH and other reasons, so preoperative OCT cannot give a clear diagnosis, so the use of intraoperative OCT can judge whether the patients are complicated with DME and give corresponding treatment. The purpose of this study is to explore the prognosis of patients with DME diagnosed by OCT during PPV and treated with PPV combined with aflibercept or PPV combined with Ozurdex, and to observe and compare the postoperative anatomical results, functional results, times of reinjections and the occurrence of adverse events between the two groups, in order to provide accurate treatment for patients, reduce the frequency of postoperative vitreous injection and lighten the burden of patients.


Eligibility Criteria:
Inclusion Criteria:

* ≥18 years of age;
* Patients and their families fully understand the research and must sign an informed consent form;
* Patients have a history of diabetes and were diagnosed with PDR by ophthalmic examination;
* Haemoglobin A1c (HbA1c) levels of \<10% within 3 months;
* No contraindication of vitrectomy;
* Pseudophakia or this operation is combined with phacoemulsification and lens implantation;
* Diagnosed with DME by intraoperative optical coherence tomography during vitrectomy

Exclusion Criteria:

* The follow-up period is less than 6 months;
* Patients need gas or silicon oil tamponade;
* Patients with rubeosis iridis, neovascular glaucoma and endophthalmitis;
* Patients with other intraocular surgeries (except cataract surgery with no ruptured posterior lens capsule);
* Patients with other retinal diseases (i.e., age-related macular degeneration, retinal vein occlusion);
* Patients received intravitreal Ozurdex three months prior to screening or anti-VEGF injection one month prior to screening;
* Patients with uncontrolled systemic disease
Low Intensity Blood Flow Restriction Training Study

The particpant will complete baseline testing by measuring subjects' quadriceps muscle thickness (cm) via ultrasound technology, as well as have them complete a one repetition maximum (1RM) test on the leg press machine and an isometric knee extension using a dynamometer - strength measures will be calculated for both right and left legs. After baseline testing, subjects will complete 6 weeks of the testing protocol that will consist of leg press exercises at 30% of their 1RM. Subjects will be randomized to either wear a cuff that partially restricts blood flow to the limb (Study Group), or to wear a cuff that does not restrict blood flow (Control Group). Exercises will be completed 2x/week and will take approximately 10 total minutes (5 for warm up, 5 for testing protocol) per session. After 6 weeks, muscle thickness, leg press 1RM, and quadriceps extension strength will be re-tested and compared to the initial measurements.

Session 1 - baseline testing

* 5-minute warm-up; 1RM calculation for both right and left legs using a supine leg press machine; isometric quadriceps strength measurement using a dynamometer; muscle thickness measurements of both right and left quadriceps muscle using ultrasound technology.
* After day 1 testing; randomly allocate subjects to either control group or experimental group

Sessions 2-13 - 6 weeks of exercise protocol, 2x/per week

Both the experimental and control groups will complete the same protocol for the entirety of the study:

* 5- minute warm up
* Using a single-leg press exercise machine: Subjects complete the testing protocol with either partial blood flow restriction (cuff inflated to 100-250 mmhg depending on size of person) or no blood flow restriction (placebo inflation) on right limb.

  * Protocol: 30 repetitions - 15 repetitions - 15 repetitions - 15 repetitions with each set separated by \~30-90 seconds.
  * Right and left legs will be alternating, but only one leg will have the occlusion cuff

Session 14 - Re-test

- Re-check 1RM, isometric quad strength, as well as muscle thickness of quadriceps with ultrasound

Eligibility Criteria:
Inclusion Criteria:

* Age 18-49

Exclusion Criteria:

* Pregnant
* Hypertensive
* Recent back or lower extremity injury
* History of blood clotting
* Varicose veins
* Adults lacking the capacity to consent for themselves
FASENRA SCEI for Long-term Use

The purpose of the investigation is to confirm the safety and efficacy under the post-marketing actual long-term use of FASENRA Subcutaneous Injection 30 mg Syringe.

The purpose of the investigation is to confirm the followings under the post-marketing actual long-term use of FASENRA Subcutaneous Injection 30 mg Syringe.

1. Detection of unexpected Adverse Drug Reactions
2. To grasp development of Adverse Drug Reactions
3. To grasp contributing factors possibly having an impact on the safety and efficacy
4. Development of key investigational safety specification (serious infection).

Eligibility Criteria:
Inclusion Criteria:

-The evaluable patients treated with Fasenra for the first time due to "Bronchial asthma (only the patients with intractable bronchial asthma which could not be controlled with the existing therapy).

Exclusion Criteria:

-No past history of hypersensitivity to the components of Fasenra.
The Effect Of Animal-Assisted Intervention

The aim of the study is to examine the effect of animal-assisted practice on fear in children admitted to the emergency room.

Children's fears about the hospital are traumatic and confront us as a hindering factor in their growth and development.Bringing the child to the emergency room and not knowing what will happen there creates great fear in him. Children already have different fears according to different age groups and developmental stages. These; separation from family, pain and suffering, change in body image (losing body parts), etc. The state of fear can lead to a worsening of the child's existing illness and symptoms. In addition to being separated from the family, being separated from peers, not being able to play games, staying away from school if going to school, etc. they have concerns.

Eligibility Criteria:
Inclusion Criteria:

* To be followed for at least 2 hours in the pediatric emergency room,
* Age range is 5-7,
* Not afraid of the goldfish to be used in the research,
* Not allergic to fish and fish feed,
* Does not have physical, auditory, visual and cognitive barriers to feeding (feeding),
* No speech or communication disorder that will prevent the parent and child from communicating,
* Parent and child's willingness to participate in the research

Exclusion Criteria:

* Patients who are not admitted to the Pediatric Emergency room, patients who do not fit the age range of 5-7, who stay less than 2 hours,
* Afraid of goldfish, allergic to fish food, preventing feeding, having physical, auditory, visual and cognitive disabilities,
* Patients with speech and communication disorders that will prevent parents and children from communicating,
* Parent and child not willing to participate in the research.
Thiol/Disulphide Homeostasis and Preeclampsia

Objective: To evaluate serum evaluate thiol/ disulfide levels in preeclampsia and address its relationship with its severity.

Methods: This prospective study will include 50 pregnancies complicated with preeclampsia and 50 healthy pregnancies. The blood for analysis will obtain at the admission and serum thiol/ disulfide levels will measure using commercially available reagent kits. The continuous values were evaluated using Student's t-test, and categorical values were evaluated using the Chi-square test. P values \< .05 were accepted as significant.

This is an observational prospective cohort study will conduct at Obstetrics and Gynecology Department of Cengiz Gokcek Obstetrics and Children's Hospital between April and October 2019. One hundred women will enrol in the study in two groups. We will consecutively recruit 50 pregnancies complicated with preeclampsia, and 50 healthy pregnancies will select for the control group. All patients will give their oral and written informed consent before their inclusion in the study. The protocol was approved by the Ethics Committee for Clinical Research of Gaziantep University (Reference number: 2019/147). The study strictly will adhere to the principles of the Declaration of Helsinki.

Eligibility Criteria:
Inclusion Criteria:

* preeclampsia
* healthy pregnancy

Exclusion Criteria:

* pregnant women with any systemic condition (such as chronic hypertension, diabetes mellitus, thyroid diseases, liver and kidney diseases)
* women with a history of drug use throughout pregnancy
* history of medication for PE treatment at the time of first admission
* patients who had fetal congenital abnormalities or genetic syndromes
* multiple gestation
* active labor