cyrilzakka/clinical-trials huggingface dataset:
Pulse Oximeter for Sleep Evaluation

The investigators will conduct this study to validate Belun Ring for sleep assessment. The investigators will compare Belun Ring data collection and overnight in-lab polysomnography (PSG) measures of SDB and sleep architecture in adults with OSA symptoms.

The investigators propose to recruit a total of 40 participants with symptoms of obstructive sleep apnea. The investigators will i) validate the overall accuracy, sensitivity and specificity of Belun Ring to assess SDB and sleep architecture, using PSG analysis as a gold standard.


Eligibility Criteria:
Inclusion Criteria:

1. Age between 18 to 80 years old. Ideally balanced for sex and age (18 to 80 years old)

   * No more than 75% of subjects in one bin of: (male, female)
   * No more than 50% of subjects in one age-group (18-29, 30-39, 40-49, 50-59, 60-80)
2. Patients with OSA symptoms (snoring, excessive daytime sleepiness or witnessed apnea, etc.)
3. Without any unstable medical or psychiatric co-morbidities that would be expected to interfere with the study.
4. If taking any medication, must be on a stable dose of medication for a month
5. Able to read and understand English

Exclusion Criteria:

1. Presence of any significant systemic or unstable medical condition which could lead to difficulty complying with the protocol, suicidality, current regular use of psychiatric medications, opiates, or thyroid medications, dementia, current substance abuse, post-traumatic or psychotic disorders, bipolar disorder; any significant neurologic disease, including possible and probable dementia, Parkinson's or Huntington's disease, brain tumor, progressive supranuclear palsy, seizure disorder, subdural hematoma, multiple sclerosis, history of significant head trauma, history of alcohol or substance use disorder within the past 2 years (DSM V criteria);
2. If positive airway pressure (PAP) titration study or split night study (diagnostic and PAP titration study combined)
3. Under 18 or over 80 years of age
Robotic vs. Laparoscopic vs. Open Living Donor Hepatectomy

This will be a study to examine the outcomes of open, laparoscopic, and robotic Living Donor Liver Transplantation (LDLT) procedures. The analysis will encompass 3,448 cases (1,724 donor-recipient pairs) from January 2011 to March 2023, documenting the transition between these surgical techniques, with a noted crossover in 2018.

Background: Liver transplantation is a primary treatment for end-stage liver disease, enhancing survival rates and life quality. Living donor liver transplantation (LDLT) has gained prominence due to the scarcity of deceased donor organs. Historically, the open technique dominated living donor hepatectomies. However, advances in minimally invasive surgery (MIS) led to laparoscopic and later robotic procedures. With the introduction of robotic surgery, MIS for complex surgeries improved, offering better precision and ergonomics.

Objective: To compare the short and long-term outcomes of open, laparoscopic, and robotic LDLT, focusing on both donors and recipients.

Methods: Study Design: Retrospective analysis of data from a prospective liver transplant registry, examining three LDLT techniques.

Setting: King Faisal Specialist Hospital and Research Centre, Riyadh, Saudi Arabia.

Participants: All consecutive living donor and recipient pairs undergoing LDLT between January 2011 and March 2023. Exclusions include dual or domino LDLT.

Surgical Techniques: Open, laparoscopic, and robotic techniques used for donor hepatectomies.

Variables: Primary focus on morbidity, conversion rates, and in-hospital mortality for both donors and recipients. Secondary variables will include major complications, graft, and recipient survival rates.

Data Sources and Measurement: Data sourced from a secured, encrypted transplant database, detailing patient data, operation characteristics, and post-op outcomes. Complication severity will be captured using the Clavien-Dindo classification and Comprehensive Complication Index™.

Study Size: Determined by the total number of procedures during the study duration, deemed sufficient for comparison.

Quantitative Variables: Demographics, comorbidities, operational details, post-op and long-term outcomes.

Statistical Methods: Various statistical tests will be employed for comparison, including the Student t, Mann-Whitney U, one-way ANOVA, Fischer and Chi square. Survival will be evaluated using the Kaplan-Meier method. Multivariable binary logistic regression will be employed. All statistical analyses will be conducted using R.

Ethics Approval: Obtained (ID: RAC 2121012) and in accordance with the 1964 Helsinki declaration.

Eligibility Criteria:
Inclusion Criteria:

* All donor and recipient pairs that underwent LDLT at the study institution
* Between 01 January 2011 to 31 March 2023
* Both adult-to-adult and adult-to-pediatric LDLT are included.

Exclusion Criteria:

* Dual and domino LDLT are excluded.
Efficacy of ECE PEDO (Equipment for Clever Exercise) on Abdominal Obesity

Objective: To show the effectiveness of walking with ECE PEDO (Equipment for Clever Exercise) comparing supervised treadmill walking corresponding moderate aerobic exercise intensity on abdominal obesity and cardiorespiratory capacity.

Objective: To show the effectiveness of walking with ECE PEDO (Equipment for Clever Exercise) comparing supervised treadmill walking corresponding moderate aerobic exercise intensity on abdominal obesity and cardiorespiratory capacity.

Methods: Twenty-eight women with overweight and obesity were assigned to two groups: supervised treadmill walking (Group I,n=14) or walking with ECE PEDO (Group II,n=14). Target heart rate(HR) corresponding to values of 50-70% VO2max were determined by the submaximal treadmill test. Group 1 was instructed walking at their target HR on a treadmill. The number of steps taken in a minute corresponding to target HR was determined by a criterion pedometer and group 2 was instructed walking in these step range recorded to ECE PEDO giving audible feedback. Before and after a 12-week exercise program, participants were evaluated by BMI and waist circumference(WC); ultrasonographic visceral fat thickness(VFT) and ergospirometric VO2max.

Eligibility Criteria:
Inclusion Criteria:

* Eligible participants who meet the criteria for inclusion were women with overweight weight or obesity and were 26-60 years old with a BMI (in kg/m2) from 27.1 to 39.6 and, waist circumference \> 80 cm.

Exclusion Criteria:

* The exclusion criteria were BMI values less than 24.9 and higher than 40, presence of a atherosclerotic heart disease, musculoskeletal or systemic diseases contradicting the exercise, a neurological or psychiatric disease affecting cooperation and cognitive function, and participation in a calorie restricted diets.
Aqueous Concentrations and PGE2 Inhibition of Ketorolac 0.4% vs. Bromfenac 0.09% in Cataract Patients: Trough Drug Effects

The purpose of this study is to compare the ability of two different topical NSAIDs (non-steroidal anti-inflammatory medications used for pain relief) to reach the back of the eye and to stop inflammation. The study will conclude on the day of your cataract surgery.


Eligibility Criteria:
Inclusion Criteria:

1. Healthy Male/Female 21 years of age of older.
2. Patient understands and is willing to sign the written informed consent form
3. Likely to complete the entire course of the study.
4. Patient is scheduled to undergo cataract surgery
5. Female patients of childbearing potential must have had a regular menstrual cycle prior to study entry (a female is considered of childbearing potential unless she is postmenopausal, without a uterus and/or both ovaries, or has had a bilateral tubal ligation).
6. Patient is willing and able to administer eye drops and record the times the drops were instilled

Exclusion Criteria:

1. Patient has been using a topical NSAID within 1 week of study entry
2. Patient has a known sensitivity to any of the ingredients in the study medications
3. Patient has sight in only one eye
4. Patient has a history of previous intraocular surgery
5. Patient's doctor has determined they have a condition (i.e., UNCONTROLLED systemic disease) or are in a situation that may put them at significant risk, confound the study results or may interfere significantly with their participation in the study
6. Female patients who are pregnant, nursing an infant or planning a pregnancy
7. Patients who are currently involved in another investigational study or have participated in one within the 30 days prior to entering this study
Choroidal Blood Flow in Acute and Chronic Central Serous Chorioretinopathy

Patients with central serous chorioretinopathy (CSC) will be monitored with laser speckle flow graphy (LSFG), swept source optical coherence tomography (SS-OCT) and SS-OCT angiography (SS-OCTA). The aim is to unveil the flow and pulse wave characteristics of the choroidal circulation in acute CSC and chronic CSC.

Acute CSC - The proposed study tests the hypothesis that choroidal blood flow characteristics are related to the eventual resolution of subretinal fluid. Such relation can shed light on pathophysiological disease mechanisms and constitute a biomarker for disease activity.

Chronic CSC - The proposed study tests the hypothesis that choroidal blood flow characteristics will change in response to standard treatment with PDT. The research of such changes will increase the understanding of the treatment response. This knowledge will help in the effort to understand the why some patients are non-responsive to the treatment.

Eligibility Criteria:
Inclusion Criteria:-

* Able to sign informed consent
* Possible to obtain fundus imaging
* Acute CSC ˂4 months of duration in one eye, defined as:

  1. Subfoveal presence of SRF on OCT
  2. Present attack is 1st -3rd attack of CSC

  b) Patient history and examination consistent with acute CSC c) Characteristic appearance of acute CSC on fundus autofluorescence (FAF) and OCT
* Chronic CSC ≥4 months of duration in one eye, defined as:

  1. Subfoveal presence of SRF on OCT
  2. Subjective visual loss/symptoms
  3. Characteristic appearance of chronic CSC on FAF, fluorescein angiography (FA), and indocyanin angiography (ICGA) and OCT
  4. Patient history and examination consistent with chronic CSC

Exclusion Criteria:

* History of retinal disease other than CSC (e.g. retinal detachment)
* Contraindications for FA, ICGA or PDT (only for chronic CSC)
Clinical & Radiological Assessment of Rotator Cuff Healing After Single Row Vs. Double Row Rotator Cuff Repair

This study is to analyse whether there is a difference in clinical and radiological outcomes between single row and double row repair techniques for the treatment of shoulder's rotator cuff tears.

A tear of the rotator cuff is one of the most common disorders of the shoulder and can have a significant effect on daily activities as a result of a loss of motion and strength. The goal of rotator cuff repair is to treat the patient's current clinical symptoms and improve shoulder function and to prevent the long-term consequences of rotator cuff arthropathy. This project aims at a retrospective analysis of preexisting risk factors for sustaining rotator cuff injury as well as for failing to reach the previous functional level, used surgical technique -either single row repair or double row repair- and its significance for the functional outcome.

Eligibility Criteria:
Inclusion Criteria:

* Treated by single row or double row repair technique for shoulder's rotator cuff tears
* Time lapse from injury to surgery ranges from one day to less than 1 year
* Availability of clinical and radiological outcomes from 6 months to 1 year follow up

Exclusion Criteria:

* Massive irreparable tear
* Patient has frozen shoulder
* Chronically retracted tendons and atrophic rotator cuff muscles
CLABSI Prevention With Tissue Adhesive

Our aim is to test the effect of tissue adhesive application at the Central-line exit-site on CLABSI rates in high-risk pediatric congenital heart disease patients.

Health-care associated infections (HAI) and especially central-line associated blood stream infections (CLABSI) are a well described burden in the intensive care units. There are two main possible pathways leading to central-venous line (CVL) related infection: the first is migration of microbes down the catheter tract (between the CVL and the skin), and the second is via the catheter hub/lumen. Cyanoacrylate adhesive is a commonly used tissue adhesive in children and adults with frequent use in pediatric facial lacerations. Several studies have shown its feasibility and safety in the general pediatric population, including neonates and in children after cardiac surgery.

To our knowledge, no study to date has explored the use of 2-octyl cyanoacrylate at central-line exit site as a mean to decreases pediatric CLABSI.

Our aim is to assess 2-octyl cyanoacrylate association with CLABSI rate in pediatric cardiac intensive care population.

Eligibility Criteria:
Inclusion Criteria:

All patients admitted to pediatric cardiac ICU (PCICU) defined as high-risk for CLABSI (any of):

* young age\<1y \& Congenital Heart Surgery Mortality Category (STAT\\STS-EACTS) score 2-5
* Risk Adjustment for Congenital Heart Surgery (RACHS) category ≥3
* preoperative length-of-stay (LOS) \>7 days
* preoperative ventilator support
* presence of a genetic abnormality
* extracorporeal membrane oxygenation (ECMO) support

Exclusion Criteria:

* Patients with on-going bacteremia
* patients with pre-existing central-line or peripherally inserted central catheter (PICC)
* parental refusal to participate.
Feasibility and Effectiveness of a Pilot Program of Physical Activity to Improve HIV Related Functional Limitations and Disability in Adults Aged 40 and Older From Côte d'Ivoire

The goal of this interventional study is to document the importance of HIV-related disabilities, notably the frequency / nature of functional limitations, neurocognitive impairments, and restrictions of social participation in adults living with HIV aged 40 and older.

Participants will undergo a comprehensive set of cognitive and functional assessments, and approximately twenty particpants will be asked to participate in an anthropological survey conducted through structured interviews.

Researchers will a group of people living with HIV and o reference group without HIV infection.

This is a mixed-methods study combining a cross-sectional study during which clinical evaluations, functional tests, and quantitative evaluations by questionnaire relating to disability (WHODAS, HDQ), depression (PHQ-9) will be conducted. and an anthropological survey. The study takes place in the Abobo district, Abidjan, in two health centers.

The quantitative evaluation will concern 300 people living wiht HIV (PLHIV) receiving antiretroviral therapy and followed at the Avocatier health facility (FSU) and the El Rapha medical health centre (CMS), in the Abobo district, Abidjan. A comparison group of adults without HIV infection of similar sex and age distribution will also be included as a reference group (n = 150).

The qualitative research will include around 20 PLHIV selected so that enough diversity is represented (sex, age, family situation). It will be based on conducting interviews to examine how the practice of physical activity is perceived culturally and socially and to determine the factors that may influence the implementation of this type of activity.

Eligibility Criteria:
Inclusion Criteria:

Participants living with HIV:

* Age ≥40 years
* Documented HIV-infection
* Combined ART for ≥12 months
* Written consent to participate to the study

Controls:

* Age ≥40 years
* Negative HIV test within the last 12 months;
* Living in Abobo area
* Written consent to participate to the study

Exclusion Criteria:

Participants living with HIV:

* HIV infection with HIV-2 type only
* Any clinical symptoms suggesting an acute infection
* Any life-threatening pathology in the short term or any pathology not allowing participation in the study

Controls:

* Any clinical symptoms suggesting an acute infection
* Any life-threatening pathology in the short term or any pathology not allowing participation in the study
Effectiveness of Nefopam in Breast Cancer Surgery

Breast cancer surgery is known to cause severe acute postoperative pain, which can persist for a long time. The investigators administered nefopam preventively to patients undergoing total mastectomy or modified radical mastectomy with axillary lymph node dissection or sentinel lymph node biopsy, and evaluated its efficacy on acute and chronic postoperative pain.


Eligibility Criteria:
Inclusion Criteria:

* Total mastectomy
* Modified radical mastectomy
* Nipple-sparing mastectomy
* American Society of Anesthesiologists physical status I or II
* Postoperative use of intravenous patient-controlled analgesia

Exclusion Criteria:

* Chronic analgesia medication
* Pregnancy
* Lactating women
* Previous operation history due to breast cancer
* Cooperation with other surgery
* Contraindication of nefopam
Phase 4: Investigational Study to Evaluate Metformin XR Monotherapy Versus Metformin IR Monotherapy in Subjects With Type 2 Diabetes

The purpose of this study is determine if Metformin XR monotherapy in subjects with type 2 diabetes is non-inferior to Metformin IR monotherapy


Eligibility Criteria:
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

* Men and women, aged ≥18 years old at time of enrollment
* Treatment naive subjects with type 2 diabetes mellitus with inadequate glycemic (HbA1c ≥7.0% and ≤9.2% obtained at screening visit) control on diet and exercise alone
* Women must have a negative serum or urine test within 24 hours prior to start of investigational product

Exclusion Criteria:

* History of ketoacidosis, lactic acidosis or hyperosmolar non-ketonic coma
* Symptoms of poorly controlled diabetes, including but not limited to marked polyuria and polydipsia with \>10% weight loss during last 3 months
* Serum creatinine ≥1.50 mg/dL (133 μmol/L) for male subjects; serum creatinine ≥1.40 mg/dL (124 μmol/L for female subjects)
Medical Students and Psychoactive Substances Use

Medical students are heavy users of psychoactive substances, and even if levels of use vary depending on the universities, the average levels are higher than most other students.

In France, however, the use of licit or illicit substance has not been precisely described in medical students. The aim of this study was therefore to define the different modes of consumption of medical students.

Methods: This study was a cross-sectional survey in medical students from the University of Montpellier, and the investigators performed a cluster analysis of data. Both medical students and residents were included. Socio-demographic, medico-psychological and addictological data were collected.


Eligibility Criteria:
Inclusion criteria:

* students had to be aged 18
* to be medical students

Exclusion criteria:

- refusal
Non-invasive Ventilation and Oxygen Therapy in Cystic Fibrosis Patients With Nocturnal Oxygen Desaturation

The purpose of this study is to determine whether correction of low nighttime oxygen (O2) levels and/ or high carbon dioxide levels in patients with cystic fibrosis improves their quality of life. The treatments being used overnight are (1)O2 (2)pressurised air which assists breathing (non-invasive positive pressure ventilation, NIPPV)

Cystic fibrosis is the commonest life-limiting genetic disorder in the Caucasian population with a median survival of 31 years. Lung disease is responsible for the majority of morbidity and mortality and correlates with declining quality of life. Respiratory failure is the primary cause of death. Daytime respiratory failure (hypoxia with pO2\<55 and/or hypercapnia with pCO2\>50) is associated with a worse prognosis with a 2-year survival of 50%. Nocturnal respiratory failure (greater than 5% of the night spent with SpO2\<90% and/or rise in PtcCO2\>10mmHg overnight) is a precursor to the development of daytime respiratory failure. It has been postulated that earlier treatment of respiratory failure may improve outcome and quality of life.

Intervention: Nocturnal O2 and bilevel NIPPV in CF patients with nocturnal respiratory failure, compared to nocturnal placebo (air). Crossover trial utilising patients as their own control.

Aims: (1) To assess the effects of non-invasive ventilation (NIV) and oxygen (O2) therapy on quality of life, hospital admission rate, sleep quality and exercise tolerance in CF patients with NRF (2) To identify a level of severity of NRF where treatment with NIV is effective

Eligibility Criteria:
Inclusion Criteria:

proven diagnosis cystic fibrosis, age 18 years or older, FEV1\< 70% predicted normal, clinically stable (no admission or antibiotics last 2 weeks, OR end of admission where further clinical improvement not expected), nocturnal respiratory failure (SpO2\<90% for \> 10% of night or rise in PtcCO2 \> 5 mmHg in REM), daytime hypercapnia (PaCO2\> 45 mmHg)

Exclusion Criteria:

Previous home O2 or NIV use, Sedative medications, Cardiac/renal/endocrine/neurological disease likely to compromise ventilatory control
Galectin-3 Blockade in Patients With High Blood Pressure

This study will investigate if Modified Citrus Pectin (MCP) can help people with high blood pressure. MCP is a dietary supplement that is derived from plants, and therefore is not subject to approval by the U.S. Food and Drug Administration (FDA). However, MCP has been deemed as 'generally regarded as safe' by the FDA.

This study will examine whether Modified Citrus Pectin (MCP) can help people with high blood pressure. The study will help understand how MCP may affect the risk for heart disease in patients with high blood pressure.

Gal-3 appears to be a potential mediator of cardiac fibrosis, preceding the development of clinical heart failure. In this study, we seek to identify individuals at risk for the development of heart failure based on clinical hypertension and elevated Gal-3 concentrations. Participants will be randomized to receive a Gal-3 inhibitor (MCP) or placebo. The primary outcome will be the effect on collagen metabolism, and secondary outcomes include echocardiographic measures of cardiac structure and function, and non-invasive measures of vascular function.

Eligibility Criteria:
Inclusion Criteria:

* Age 21-70 years
* Physician diagnosed hypertension on stable therapy for 3 months
* Elevated galectin-3 level (above sex-specific median based on Framingham Heart Study measures)
* Able to understand the protocol and provide informed consent in English

Exclusion Criteria:

* Uncontrolled hypertension, defined as systolic blood pressure \> 170mmHg, diastolic blood pressure \> 100mmHg
* Evidence of secondary hypertension
* History of heart failure, coronary artery disease, stroke, atrial fibrillation
* Left ventricular ejection fraction \< 45% on echocardiography
* Use of aldosterone antagonists
* History of liver cirrhosis
* History of pulmonary fibrosis
* Kidney dysfunction, defined as estimated glomerular filtration rate \< 45 ml/min/1.73m2
* Anemia, defined as hematocrit \< 37% in men and \< 34% in women
* Use of chelating agents
* History of Active cancer or malignancy
* Known pregnancy, those unwilling to avoid pregnancy during the course of the study, or women currently breastfeeding
* Hyperkalemia on screening labs, defined as potassium \>5.2
* Anticipated inability to complete or comply with study protocol
* History of angioedema