cyrilzakka/clinical-trials huggingface dataset:
Sleep Apnea, Obesity and Pregnancy

Main objective:

Determine the prevalence of obstructive sleep apnea syndrome (OSA) in late pregnancy in a population of obese patients .

Secondary objectives :

* Identify risk factors for OSA during pregnancy (age, parity, high blood pressure, snoring , weight, neck circumference, scores on symptoms of sleep apnea, ... ) .
* Compare perinatal morbidity among obese patients with OSA in late pregnancy with case-controls.
* Evaluate the evolution of a moderate or severe OSA 6 months after pregnancy.

Material and methods

Characteristics of the study:

* Interventional biomedical research
* Prospective Multicenter nonrandomized study

Flow chart

* Patients will be included between 30 and 36 weeks of amenorrhea (WA) .
* Will rated from inclusion: age, parity, weight, height, BMI in early pregnancy, neck circumferrence, treated high blood pressure.
* As recommended in France, the main test results during the pregnancy follow-up will be recorded.
* At the inclusion visit will be conducted a Berlin Questionnaire and Epworth Score.
* Screening for OSA by nocturnal polysomnography will be performed between 30 and 36WA. This screening can be performed as an outpatient.
* In case of proven OSA patients will be offered an appropriate care by today's standards.
* Whatever the outcome of pregnancy, a second polysomnography will be performed 6 months after childbirth in case of OSA during pregnancy.


Eligibility Criteria:
Inclusion Criteria:

* BMI \>35
* Pregnancy after 30 Weeks of amenorhea
* Age \> 18
* Signed consentment
* Nationnal Health Program affiliation

Exclusion Criteria:

* Twin or more pregnancy
* Imprecise term
* Artificial insemination with donor gametes
* Proved thrombophilia
* chronic renal failure
* Previously treated (with CPAP) obstructive sleep apnea syndrom
Intra-operative Trans-rectal Ultrasound Guidance for Robot-assisted Radical Prostatectomy

Radical prostatectomy, or the surgical extirpation of the prostate, is a standard treatment for prostate cancer. The state of the art radical prostatectomy involves a robotic laparoscopic surgery system (the da Vinci) which provides the surgeon with excellent 3D visualization of the surgical site and improved dexterity over standard laparoscopic instruments. While the long term prognosis of prostate cancer patients who undergo radical prostatectomy has improved significantly over the past two decades, there remain significant rates of disease recurrence and complications.

The investigators hypothesis is that advanced trans-rectal ultrasound (TRUS) imaging can be deployed and used easily during surgery, can be registered to the robot coordinate systems with high accuracy, and can be controlled from the surgeon's console, in order to improve the visualization of the prostate and peri-prostatic anatomy, and in order to produce a cancer probability map that can be used to make decisions on surgical margins.

The investigators objectives are

1. To demonstrate that TRUS imaging can be integrated with the da Vinci radical prostatectomy
2. To determine the ability of TRUS imaging to intra-operatively visualize the prostate and peri-prostatic tissue from the surgical console

This is an observational study; trans-rectal ultrasound will be used to visualize the prostate and periprostatic structures during surgery but the standard of care will not be affected by this ultrasound imaging.


Eligibility Criteria:
Inclusion Criteria:

* All men who undergo robot-assisted radical prostatectomy are eligible.

Exclusion Criteria:

* None
Effect of Lifestyle Intervention Among Patients With Hypertension or High-normal Blood Pressure

Hypertension is a major risk factor for cardiovascular disease and cardiovascular events. Healthy lifestyle factors are widely recommended for hypertension prevention and control, and cardiorespiratory fitness is a strong and independent predictor of the progression of hypertension. Increased cardiorespiratory fitness through lifestyle modifications is associated with lower mortality in hypertensive or high-normal blood pressure individuals. The aim of the study is to evaluate the effects of supervised lifestyle intervention that include diet and exercise and base on intelligent application and continuous physiological monitoring on improvement of cardiopulmonary fitness, blood pressure and other health outcomes among participants with hypertension or high-normal blood pressure.


Eligibility Criteria:
Inclusion Criteria:

1. who is ≥18 years old and \< 70 years old;
2. hypertension or high-normal blood pressure;
3. who has a smart phone and can use it (android phones are preferred).

Exclusion Criteria:

1. with acute myocardial infarction, acute tachyarrhythmia, pulmonary edema, severe aortic stenosis and other serious circulatory diseases or respiratory diseases;
2. with acute cardiovascular and cerebrovascular diseases;
3. poor blood pressure control;
4. with physical limitations(e.g., restricting injuries of the musculoskeletal system, such as fractures, unstable joints and other physical diseases);
5. with skin disease or skin damage at the site of wearable device;
6. with mental disorder, epilepsy or other diseases resulting in inability to control the body;
7. pacemaker installation;
8. woman who is during pregnancy or prepare for pregnancy;
9. sensitive skin for wearable devices; 10）refuse to provide written informed consent.
MANAGE AT WORK: Addressing the Challenge of Chronic Physical Health Conditions in the Workplace

The specific aim of the study is to evaluate the health benefits of a series of group workshops designed for workers with chronic physical health conditions. The facilitated workshops apply principles of pain and illness self-management to help workers deal with health-related challenges while at work. The workshops address issues of pain management, physical job demands, pacing of work, communication, problem solving, and coping. Half of the participants in the study will be randomly assigned to attend workshop sessions (10 hours total), and all study participants will be followed for one year. The primary hypothesis is that workers who participate in these workshops will show improvements in work engagement and reductions in work limitation in the subsequent 12 months.

One significant trend in the US workforce is the advancing median age of workers and the growing prevalence of chronic medical conditions that contribute to workplace pain, fatigue, task limitations, and reduced productivity. The proposed multi-site study is a randomized, controlled trial of a multi-session group intervention program targeting workers with chronic health concerns (N = 300). The primary outcome measures will be self-report measures of work limitations and work engagement measured at baseline, 6 months, and 12 months follow-up. Secondary outcomes will include turnover intention, sickness absence, job satisfaction, and healthcare utilization. Process variables and covariates will include assessment of self-efficacy, work-related fatigue, emotional distress, work characteristics, general health status, and basic demographic variables. The study should provide an assessment of whether principles of symptom self-management can be successfully applied to workplace problems and delivered in a group workshop format to reduce the disabling effects of chronic medical conditions.

Eligibility Criteria:
Inclusion Criteria:

* Workers with at least one chronic physical condition (\> 6 months).
* Working full time (at least 20 hours per week).
* Able to read and speak in English language.

Exclusion Criteria:

* Impending retirement or major career change (next 12 months).
* Not available to attend group workshops after working hours.
Innovative Stratification of Arrhythmic Risk (ISAR-Trial): Female Patients

The purpose of this study was to investigate differences in risk prediction in female post-infarction patients.


Eligibility Criteria:
Inclusion Criteria:

acute myocardial infarction; female gender

Exclusion Criteria:

-
Preoperative Shielding and N/T RT-PCR Swabbing for Elective Cancer Surgery

trial to assess the effectiveness of pre-operative screening for COVID-19 in patients undergoing elective cancer surgery.

1. Background:

   The optimal method of screening patients for COVID infection before elective cancer surgery is unclear. Provisional data from the international COVIDsurg audit as well as a similar study from China has shown mortality rates of in excess of 20% for COVID +ve patients undergoing surgery and so ensuring patients do not have infection before surgery is critical (1).

   Current practice for the preoperative screening of elective surgical patients involves a period of self-isolation, assessment of self-reported symptoms and nose and throat swab testing. Many patients are asymptomatic with COVID and the false negative rate of RT-PCR nose and throat swabs may be as high as 30% (2,3). Furthermore, we do not know how effective our strategy is at preventing hospital acquired COVID in the days after surgery. Patients are currently going to designated clean (silver) wards postoperatively to reduce this risk with other patient who have tested negatively to the above screening process too
2. Rationale:

The aim of this study is to assess the rate of perioperative COVID in elective surgical patients, and to assess whether RT-PCR swabbing adds any additional value i.e. does it detect clinically important asymptomatic patients.

If asymptomatic patients are diagnosed preoperatively this will reduce perioperative morbidity and mortality as well as confirming this as an appropriate preoperative screening process. Alternatively, should nose and throat swabbing not improve the diagnosis of COVID-19 in asymptomatic patients this trial may stop unnecessary visit to the hospital where they may be more likely to contract COVID-19 and reduce the use of a limited resource.

Eligibility Criteria:
Inclusion Criteria:

* participants capable of giving informed consent,
* gender: Male and Female
* Age: 18 years and above
* Preoperative cancer patients (elective)
* Willing to be contacted by phone after hospital discharge
* Patients listed for inpatient admission postoperatively (cancer patients)

Exclusion Criteria:

* Cancer patients who require non-cancer surgery
* emergency cancer operations
* Patients under the age of 18
* Patients who do not have capacity to consent
* Cancer patients not requiring an inpatient stay postoperatively
* Patients who it was not anticipated would require an inpatient stay preoperatively but required admission after surgery
Sustained Oral Fiber Supplementation for Patients Undergoing Donor Stem Cell Transplantation for Hematological Malignancies

This clinical trial examines sustained oral fiber supplementation for patients undergoing donor stem cell transplantation for hematological malignancies. Patients undergoing donor stem cell transplantation often develop oral and gastrointestinal damage from chemotherapy, radiotherapy, or graft-versus-host disease. Oral fiber nutrition support may improve overall nutrition, support a normal gut microbiome (bacteria that live in the gut) and/or improve gut function in patients undergoing stem cell transplants.

OUTLINE:

Current study design: Patients receive fiber supplementation orally (PO) or enterally starting 14 to 5 days prior to standard of care conditioning chemotherapy and continuing until discharge. Patients who are not able to receive sufficient nutrition by mouth may receive parenteral nutrition or enteral nutrition by feeding tube from the hospital. Patients may undergo blood sample collection throughout the study.

Previous study design: Before this study was amended in January 2024, patients were randomized to 1 of 2 arms.

Previous Arm I: Patients received enteral nutrition via nasoenteric feeding tube starting on day 1 until hospital discharge.

Previous Arm II: Patients received standard of care nutritional support.

After completion of study treatment, patients are followed up at days 42, 60 and 90 days post transplant.

Eligibility Criteria:
Inclusion Criteria:

* Able to provide written informed consent prior to initiation of any study procedures
* Planned allogeneic stem cell transplantation
* At least 18 years of age

Exclusion Criteria:

* Major psychiatric diagnosis that impairs cognitive functioning or is not controlled at the time of the approach, as judged by the patient's medical team
* Pregnant or breastfeeding. Pregnancy test is obtained as part of pre-transplant evaluation in women of child-bearing potential at arrival to transplant and again within 7 days of conditioning and will be confirmed as negative by review of the chart
Safety and Performance of Newly Developed 1-piece Ostomy Product Compared With SenSura

The aim of the current investigation is to evaluate the combination of an adhesive with a soft top film.


Eligibility Criteria:
Inclusion Criteria:

1. Have given written informed consent
2. Be at least 18 years of age and have full legal capacity
3. Be able to handle the bags themselves
4. Have an ileostomy with a diameter between 15 and 55 mm
5. Have had their ileostomy for at least 3 months
6. Currently use a 1-piece flat ostomy appliance with open bag
7. Use minimum 1 product every second day, i.e. maximum 2 days wear time
8. Be suitable for participation in the study and for using a standard adhesive, flat base plate
9. Must be able and willing to use custom cut products
10. Accept to test two 1-piece products within the study period

Exclusion Criteria:

1. Use irrigation during the study period (flush the intestines with water)
2. Currently receiving or have within the past 2 months received chemotherapy or radiation therapy
3. Currently receiving or have within the past month received systematic steroid or local treatment in the peristomal area
4. Are pregnant or breastfeeding
5. Participating in other interventional clinical investigations or have previously participated in this investigation
6. Currently using a ostomy belt
7. Currently using extended wear product
8. Have a loop ileostomy
9. Known hypersensitivity towards any of the test products
10. Suffering from severe peristomal skin problems prior to participation in the investigation (assessed by the study nurse)
A Phase IV Study of Travoprost + Brinzolamide to Treat Glaucoma or Ocular Hypertension

Double blind, crossover randomized, multicentric study to compare efficacy and tolerability of concomitant administration of travoprost and brinzolamide versus timolol-dorzolamide fixed combination in patients with glaucoma or ocular hypertension


Eligibility Criteria:
Inclusion Criteria:

* Written informed consent
* Diagnosis of bilateral Primary open angle glaucoma or ocular hypertension
* Intra Ocular Pressure above 19 millimeters mercury at screening visit at 8:00 AM
* Stable visual field in last 6 months
* 6 weeks wash out from previous topical medications

Exclusion Criteria:

* Age
Evaluation of the Performance of Investigational Contact Lenses in a Presbyopic Population

The objective of this study is to evaluate the performance of a novel multifocal lens system.


Eligibility Criteria:
Inclusion Criteria:

1. Subjects must read, understand, and sign the STATEMENT OF INFORMED CONSENT and receive a fully executed copy of the form.
2. Subjects must appear able and willing to adhere to the instructions set forth in the clinical protocol.
3. Subjects must be between 40 and 70 years of age.
4. Subjects' spherical equivalent distance refraction must be in the range of -3.75 to +3.75 in each eye.
5. Subjects' refractive cylinder must be less than or equal to 0.75D in each eye.
6. Subjects' ADD power must be in the range of +0.75 to +2.50D in each eye.
7. Subjects' must have the best corrected visual acuity of 20/20-3 or better in each eye.
8. Subjects' should own a wearable pair of spectacles.
9. Subjects' must be an adapted soft contact lens wearer in both eyes (i.e. worn lenses a minimum of 2 days per week for at least 8 hours per wear day, for 1 month or more duration).
10. Subjects' must respond positively to at least on symptom on the "Presbyopis Symptoms Questionnaire" or already be wearing a presbyopic contact lens correction (e.g. reading spectacles over contact lenses, multifocal or monovision contact lenses, etc.).

Exclusion Criteria:

1. Currently pregnant or lactating (subjects who become pregnant during the study will be discontinued).
2. Any ocular or systemic allergies or diseases that may interfere with contact lens wear.
3. Any systemic disease, autoimmune disease, or use of medication, which may interfere with contact lens wear.
4. Any previous intraocular surgery (e.g. radial keratotomy, PRK, LASIK, etc.)
5. Any grade 3 or greater slit lamp findings (e.g. edema, corneal neovascularization, corneal staining, tarsal abnormalities, conjunctival injection) which may contraindicate contact lens wear.
6. Any ocular infection.
7. Any corneal distortion resulting from previous hard or rigid gas permeable contact lens wear.
8. History of binocular vision abnormality or strabismus.
9. Any infectious disease (e.g. hepatitis, tuberculosis) or contagious immunosuppressive disease (e.g. HIV).
10. History of diabetes.
11. Participation in any contact lens or lens care product clinical trial within 7 days prior to study enrollment.
ERCP in Idiopathic Recurrent Acute Pancreatitis

The therapeutic impact of ERCP with sphincterotomy in the management of patients with idiopathic recurrent acute pancreatitis (RAP) needs further study. The investigators conducted a single center, feasibility, randomized trial to determine 1) the role of pancreatic manometry in predicting future episodes of RAP and 2) differences in the efficacy of no, biliary (BES) or pancreatobiliary (dual) endoscopic sphincterotomy (DES).

Patients with idiopathic RAP, defined as ≥2 unexplained (per the treating physician) episodes of acute pancreatitis (based on standard criteria) requiring hospitalization, will be prospectively enrolled. All patients will undergo ERCP with manometry, with stratified randomization based on the assessment of pancreatic basal sphincter pressure. If \<40mmHg, the patient will be randomized to sham or biliary sphincterotomy (BES). If ≥40mmHg, the patient will be randomized to BES or pancreatobiliary ("dual") sphincterotomy (DES).

Patients and physicians will not be blinded to the assignment group. Patients will be followed for up to 10 years to determine 1) incidence of RAP requiring hospitalization (using standard definitions) or 2) interval development of chronic pancreatitis (CP).

Differences between patients who did and did not develop RAP during follow-up will be compared to evaluate for factors associated with AP during follow-up.

Eligibility Criteria:
Inclusion Criteria:

* Idiopathic recurrent acute pancreatitis, defined as two or more episodes requiring hospitalization
* ERCP with SOM planned

Exclusion Criteria:

* Chronic pancreatitis
* Pancreas divisum
* Alternate etiology identified (e.g., CBD stone, IPMN)
* Inability to perform pancreatic manometry
* Pregnancy, age \< 18, incarceration
* Inability to provide informed consent
Oxitone Sp02 Hypoxia Test Versus Reference Pulse Oximetry

The purpose of this study is to conduct a SpO2 hypoxia evaluation of the Oxitone Medical Oxitone 1000 pulse oximeter. The Oxitone 1000 pulse oximeter will be evaluated during non-motion conditions over the range of 70-100% SpO2 in comparison to a Reference Pulse Oximeter.

The study is observational in nature which quantifies device performance and accuracy in compassion to a Reference Pulse Oximeter.

The purpose of this study is to conduct a SpO2 hypoxia evaluation of the Oxitone Medical Oxitone 1000 pulse oximeter. The Oxitone 1000 pulse oximeter will be evaluated during non-motion conditions over the range of 70-100% SpO2 in comparison to a Reference Pulse Oximeter. The end goal is to show the SpO2 accuracy performance of the Oxitone 1000 and if needed, use the data to make improvements prior to an arterial blood hypoxia study.

A Clinimark 3900 Reference Pulse Oximeter or Nellcor N-600x will be used for the SpO2 calibration. There are no risks or adverse device effects to be assessed. There are no contraindications for use in the proposed study / study population

The Control Pulse Oximeter, GE Healthcare (Datex-Ohmeda) 3900, an FDA cleared device, is used to monitor the oxygen saturation levels real time throughout the study for subject safety and to target stable plateaus. This device is used to assess the stability of the data.

Eligibility Criteria:
Inclusion Criteria:

* Healthy individuals between the age of 18-50

Exclusion Criteria:

* Clotting disorders, diabetes, currently taking psychotropic medications
Efficacy and Safety of Symptom Improvement by Digital Therapeutics to Manage Hypotension Symptoms

This clinical trial is an exploratory study aimed at assessing the efficacy and safety of a digital therapeutic for managing symptoms of hypotension, with the goal of providing evidence for the design of future confirmatory clinical research.


Eligibility Criteria:
Inclusion Criteria:

1. Adults aged 19 and older with symptoms suspected to be related to dizziness due to hypotension within the past year.
2. Individuals who are able to walk and can participate in the study using a smartphone, or for whom cooperation from a guardian is available.

Exclusion Criteria:

1. Individuals diagnosed with causes of dizziness other than hypotension, such as benign paroxysmal positional vertigo or stroke, within the past year.
2. Severe anemia (history of Hb \< 8.0 g/dL within the last 3 months).
3. Individuals unable to use a smartphone (Android phone) or smartwatch.
4. Individuals with a life expectancy of less than 1 year due to diseases such as malignant tumors.
5. Individuals diagnosed with severe heart valve disease or severe heart failure with LVEF \< 35% (based on the most recent examination).
6. Recent rapid and unintended weight loss (5% or more, or 5 kg or more, within the last 6 months).
Pulmonary Embolism in Exacerbations of Chronic Obstructive Pulmonary Disease

The purpose of this study is to determine the prevalence of pulmonary embolism in our population of Chronic Obstructive Pulmonary Disease (COPD) patients admitted to hospital with dyspnea. The patients will undergo investigation for pulmonary embolism, according to current guidelines.


Eligibility Criteria:
Inclusion Criteria:

* known or suspected COPD
* COPD-exacerbation

Exclusion Criteria:

* other causes of dyspnea
* unable to perform CT pulmonary angio (contrast allergy, pregnancy)
* already included in the study (each patient included only once)
* use of anticoagulants