cyrilzakka/clinical-trials huggingface dataset:
Home Retinal Imaging Using NOTAL-OCT V3.0

The study will include up to 30 AMD patients, recruited by two medical centers, Tel-Aviv medical center and Assuta Hashalom medical center. At the screening visit, the patients will be imaged in their tested, eligible eye(s), using a commercial Zeiss Cirrus or Heidelberg Spectralis OCT.

Screening visit:

For patients eligible to participate in the study, the following procedure will be done in the "screening visit" at the clinic:

1. Patient will sign the IC (Informed Consent) form
2. The following demographic and clinical data will be collected and registered in the CRF:

   1. Patient's DOB and gender.
   2. Patient's diagnosis in study eye(s), based on patient's medical record, including media opacity (e.g. cataract or corneal opacity, if exists).
   3. Bio-microscopy testing.
   4. Refraction correction by an optometrist.
   5. Habitual Snellen visual acuity
   6. Commercial OCT scanning using Zeiss Cirrus or Heidelberg Spectralis.

OCT scanning pattern:

* Macular cube of at least 6X6mm (20 degrees)
* At least 40 B-scans per cube

Setup and tutorial home visit:

The device will be delivered to the patient's home with a setup guide attached to the package. The patient will read the setup guide instructions, unpack the device, place it on a table and connect it to a power supply. Upon first usage a tutorial clip, explaining how to operate the device and self-image the eyes, will be automatically displayed on the device's external screen. Following the tutorial patients will be instructed to scan their study eye(s). A remote support service, provided by the sponsor, will be available as needed. Its phone number will be given to the patient and will be attached to the device's base.

Daily home testing:

For each eligible eye, the following procedure will be done in the "Daily testing" at the patients' homes:

1. The patients will be requested to self-scan their study eye(s) daily, using the NOTAL-OCT V3.0..
2. The patient will be able call the sponsor's remote support service, during working hours, for assistance in case of questions or problems regarding the operation the NOTAL-OCT V3.0 device.

Exit visit:

For each eligible eye, the following procedure will be done in the "Exit visit" at the clinic:

1. Bio-microscopy testing.
2. Refraction correction by an optometrist.
3. Habitual Snellen visual acuity
4. Commercial OCT scanning using Zeiss Cirrus or Heidelberg Spectralis.

OCT scanning pattern:

* Macular cube of at least 6X6mm (20 degrees)
* At least 40 B-scans per cube NOTAL-OCT V3.0 Scanning.

  6.Patient's experience questionnaire

Eligibility Criteria:
Inclusion Criteria:

1. Ability and willingness to give informed consent (IC)
2. 18 years of age or older at the time of IC
3. Tested eye(s) diagnosed with AMD
4. Visual acuity of 20/400 Snellen (6/120) or better in the study eye
5. At least one eye is with active CNV, presenting retinal fluid at the enrolment visit, undergoing active anti-VEGF treatment
6. Ability to undergo OCT testing

Exclusion Criteria:

NA
Vaginal Microbiota as a Decisive Factor in Vaginal Prosthetic Surgery

Retrospective analysis of vaginal microbiota in the post-operative course of patient operated for genital prolapse with vaginal mesh with or without mesh related complication

We propose to collect vaginal specimens to obtain exfoliated mucosal cells from women who had vaginal mesh implantation for POP complicated by mesh erosion into the vagina (cases).

We aim to recruit women who will receive exactly the same clinical investigations (outlined below), follow up and management.

Samples from patients without complications after mesh surgery will be used as controls since there are ethical difficulties in obtaining cold-cup swabs from 'normal' women and cystoscopy for conditions other than OAB or USI in premenopausal women is rare.

Both cases and controls will be identified by the urogynaecology team based on surgical outcome reports and follow-up documentation. Cases and controls will be invited to participate by the research team. Relevant members of the research team (Dr Nikolaus Veit-Rubin, Pr Renaud DeTayrac, and Mr Vikram Khullar) have extensive experience in urogynaecological investigation and pelvic floor assessment.

Cases and controls will be provided with an information leaflet about the study and will be asked to sign informed consent for the biopsies and a high vaginal swab will be taken. Consent will be taken either a trained member of the urogynaecology team. All participants will complete the 'P-QoL Questionnaire" for symptoms relative to POP. Clinical assessment will include a comprehensive relevant past medical history, calculation of BMI, urinalysis, standardized POP-Q Quantification and abdominal examination.

Specimens collected to be analysed will be a high vaginal swab following fully informed written consent. The specimens of Vaginal swab will be processed to extract and purify the DNA and then the exact bacterial genomic make up will be sequenced and analysed to identify the exact species of bacteria within the samples. Further detailed protocol of the mentioned procedures is outlined in the attached protocol.

Eligibility Criteria:
Inclusion Criteria:

* Females aged 18 and over who have consented for vaginal mesh surgery for pelvic organ prolapse at the the Nîmes University Hospital, France

Exclusion Criteria:

* Pregnant or breast feeding
* Unwilling or unable to complete questionnaire or give valid consent.
Effects of a Time Restricted Eating Protocol on Cyclists (TRECYC)

We sought to investigate the effects of 4 weeks of 16/8 time restricted eating (TRE) with windows of 16 hours of fasting and 8 hours of eating) on elite cyclists' performance, metabolic and blood parameters.

Sixteen elite under-23 cyclists were randomly assigned to a TRE group or to a control group (CTRL) with a traditional meal pattern. The TRE group consumed 100% of its estimated daily energy needs in an 8-hour time window: from 10:00 AM (ante meridiem) to 6:00 PM (post meridiem) whilst the CTRL group consumed 100% of its estimated daily energy needs in 3 meals between 7:00 AM and 9:00 PM. During the experimental period, training loads were similar in the two groups. Athletes were tested before and after 4 weeks of the intervention. Body composition , basal metabolism, performances indexes and blood parameters were measured.

Eligibility Criteria:
Inclusion Criteria:

* elite under 23 cyclists male

Exclusion Criteria:

* adherence to special diets
* use of nutritional supplements (except a daily multivitamin-mineral and/or protein supplement)
* use of medications
CardiaMend and Amiodarone for the Prevention of POAF

The principal purpose of this investigator-initiated trial is to study the use of the CardiaMend device soaked in the anti-arrhythmic drug amiodarone, and how it may decrease the development of atrial fibrillation in patients that have undergone a coronary artery bypass surgery, or isolated valve surgery.


Eligibility Criteria:
Inclusion Criteria:

* Aged 21-85 years
* Able to provide written informed consent, understand and be willing to comply with study-related procedures.
* Scheduled to undergo open-chest cardiac surgery via complete median sternotomy for coronary artery bypass graft (CABG), or isolated valve repair/replacement.
* Inclusionary valve repair/replacement procedures with the primary reason for surgery inclusive of aortic valve repair/replacement or mitral valve repair/replacement.
* Left atrial appendage (LAA) procedures are allowed if CABG and/or valve repair or replacement is the qualifying surgical procedure, but is not a qualifying surgical procedure on its own.
* In sinus rhythm at the time of consultation and on a previous EKG, or no history of atrial fibrillation (note: continuous ECG monitoring for 48 hours is not required)

Exclusion Criteria:

* Unable to give voluntary written informed consent, is unlikely to cooperate or is legally incompetent, including subjects who are institutionalized by court or official order, or in a dependency relationship with testing center or investigator.
* Any condition which could interfere with the subject's ability to comply with the study.
* Ongoing participation in an interventional clinical study or during the preceding 30 days.
* Female subjects who are pregnant, breastfeeding, were pregnant within the last three months or are planning a pregnancy during the course of the study.
* Active skin or deep infection at the site of implantation.
* History of chronic wounds or wound-healing disorders.
* Known connective tissue diseases (e.g. Ehlers-Danlos syndrome, Epidermolysis bullosa, Marfan syndrome, Osteogenesis imperfecta).
* Immune-suppressed subjects, immune-deficiency subjects (properly managed diabetes mellitus is not an exclusion criterion).
* The subject has an implantable cardiac device (i.e., cardiac resynchronization therapy devices with and without defibrillator capabilities (CRTs and CRT-Ds), implantable cardioverter-defibrillators (ICD) and pacemakers).
* Known history of atrial fibrillation (in any form including paroxysmal atrial fibrillation).
* History of ablation for atrial fibrillation.
* Patients already receiving amiodarone as a treatment for atrial fibrillation or ventricular arrhythmias during the procedure.
* Disease of the left pleura, previous intervention in the left pleural space, or chest deformity.
* Subjects with end-stage chronic-renal disease / dialysis.
* Subjects with heart failure (BNP\>1000), low ejection fraction (\<35%), end stage renal disease (on dialysis or creatinine \>1.8).
* STS risk \>5.5% for 30 day mortality.
* Patients electing to receive an ablative procedure for atrial fibrillation.
Sexual Intercourse and Vaginal Absorption of Progesterone

The objective of this project is to compare the vaginal absorption of progesterone administered in the vaginal ovum by measuring progesteroneemia in 3 situations (or "sexual event"): abstinence, sex protected by condoms and unprotected sex.

Progesterone plays a key role in embryo implantation and maintenance of pregnancy.

In the context of Assisted Reproduction (ART), support for the luteal phase is often necessary and readily provided by the administration of progesterone, mainly vaginal in Europe.

Optimal absorption is essential because low progesterone levels are associated with the chances of lowered pregnancies.

However, it has been shown that vaginal absorption can be reduced following unprotected sex.

Would the use of a condom prevent this alteration of vaginal absorption?

Eligibility Criteria:
Inclusion Criteria:

* Couples, volunteers, on an AMP journey
* Having sexual intercourse with a low risk of transmission of sexually transmitted infection
* Free and informed consent to participate in the study

Inclusion criteria specific to women:

* aged 18 to 40 inclusive

Exclusion Criteria:

Exclusion criteria specific to women:

* Currently taking hormone therapy that may alter progesteroneemia
* Pathology that can modify progesteroneemia
* Body mass index greater than or equal to 32 kg / m2
* Contraindication to the use of hormone replacement therapy
* Known intolerance to vaginal progesterone
* Pregnant woman (βHCG assay positive) or breastfeeding

Exclusion criteria specific to men:

* Erectile or ejaculatory disorder

Exclusion criteria specific to couples:

* Person with poor oral and/or written French comprehension
* Person who for psychological, social, family or geographical reasons could not be followed regularly
* Vulnerable person (Article L1121-6 of the Public Health Code)
* Protected person or unable to give consent
* Person involvment in another clinical research
* Person not affiliated with a French social security scheme or beneficiary of such a scheme
Observational Study to Assess Transradial Access for Treatment in the Lower Extremities.

This study is designed to collect data on the complication rates and procedural success of using a transradial access approach to treat peripheral lesions in the lower extremities of a real world population.


Eligibility Criteria:
Inclusion Criteria:

* Rutherford Category 2-5
* Subject scheduled for a transradial intervention to treat a lesion in the lower extremities.
* Willing to sign consent and agree to follow-up requirements.

Exclusion Criteria:

* Previous failed transradial access attempt
* Presence of or planned dialysis fistula.
* Planned amputation
* Previous or planned transradial access intervention +/- 30 days
* Radial artery diameter \<2.5mm
* No palpable radial artery
* Established vasospastic disease
* Known allergy to contrast that cannot be managed
* Pregnant or lactating
* Mentally incompetent or a prisoner
* Currently participating in a clinical study that has not completed it's primary endpoint
Liver-gut Axis Study Through Identification of Liver Disease-specific Microbiome

In this study, we aim to identify gut microbiomes specific to patients with chronic refractory liver disease and to conduct a gut-liver axis study on the pathogenesis and disease progression.

1. The investigators will recruit study participants aged 19 and older who have been diagnosed with autoimmune hepatitis, primary biliary cholangitis, primary sclerosing cholangitis, non-alcoholic steatohepatitis, or liver abscess, along with their household members, and who have agreed to participate in this study at Chungnam National University Hospital.
2. The investigators collect and analyze blood and stool samples from the patients and their household members
3. Sampling Method: Non-Probability Samples
4. Study Population:

Group of autoimmune hepatitis: patients with definite autoimmune hepatitis or their healthy households for controls Group of primary biliary cholangitis: patients with definite primary biliary cholangitis or their healthy households for controls Group of primary sclerosing cholangitis: patients with definite primary sclerosing cholangitis or their healthy households for controls Group of non-alcoholic steatohepatitis: patients with definite non-alcoholic steatohepatitis or their healthy households for controls Group of liver abscess: patients with definite liver abscess or their healthy households for controls.

Eligibility Criteria:
Inclusion Criteria:

* Adults aged 19 years and older diagnosed with autoimmune hepatitis, primary biliary cholangitis, primary sclerosing cholangitis, non-alcoholic fatty liver disease, or liver abscess, who have consented to participate in this study at Chungnam National University Hospital.
* Adults aged 19 years and older, who are cohabitants of patients diagnosed with autoimmune hepatitis, primary biliary cholangitis, primary sclerosing cholangitis, non-alcoholic fatty liver disease, or liver abscess, and have consented to participate in this study at Chungnam National University Hospital.

B. Exclusion

Exclusion Criteria:

* Individuals under the age of 19.
* Patients or guardians who do not consent to participate in the study
Trajectories of Recovery After Intravenous Propofol Versus Inhaled VolatilE Anesthesia Trial

The investigators will conduct a 12,500-patient randomized multi-center trial to determine (i) which general anesthesia technique yields superior patient recovery experiences in any of three surgical categories ((a) major inpatient surgery, (b) minor inpatient surgery, (c) outpatient surgery) and (ii) whether TIVA confers no more than a small (0.2 %) increased risk of intraoperative awareness than INVA in patients undergoing both outpatient and inpatient surgeries


Eligibility Criteria:
Inclusion Criteria

Each patient must meet all of the following criteria:

1. Aged 18 years or older
2. Undergoing elective non-cardiac surgery expected to last ≥ 60 min requiring general anesthesia with a tracheal tube or laryngeal mask airway (or similar supra-glottic device)

Exclusion Criteria

Patients will not be enrolled if any of the following criteria are met:

1. Inability to provide informed consent in English (at all study sites) or Spanish (at sites where Spanish consent is provided as an option)
2. Pregnancy (based on patient report or positive test on the day of surgery)
3. Surgical procedure requiring general, regional, neuraxial anesthesia administered by an anesthesia clinician (anesthesiologist, CRNA, anesthesiology assistant) occurring within 30 days prior to or planned to occur within 30 days after surgery date
4. Contraindication to propofol TIVA or INVA (for example, documented allergy to propofol, history of severe postoperative nausea or vomiting, concern for or history of malignant hyperthermia) based on self-report
5. Surgical procedures requiring a specific general anesthesia technique (for example, TIVA required for neuromonitoring).
6. Locally approved, written protocol mandating a particular anesthetic technique
7. History of possible or definite intraoperative awareness during general anesthesia based on patient self-report
8. Planned postoperative intubation
9. Current incarceration
Expanded Access Study With Peginterferon Alfa-2a (Pegasys) in Participants With Chronic Myelogenous Leukemia (CML)

This study will evaluate the efficacy, safety and tolerability of long-term use of peginterferon alfa-2a in participants with CML who have previously participated in peginterferon alfa-2a study ML16544 (NCT number not available), NO16006 (NCT number not available) or ML17228 (NCT number not available) and treating physician has decided to continue treatment with peginterferon alfa-2a within the frame of another clinical study.


Eligibility Criteria:
Inclusion Criteria:

* Participants with CML
* Previous participation in studies: ML16544, NO16006 or ML17228; for which the treating physician recommends a continuation of the study drug according to defined minimal criteria

Exclusion Criteria:

* Major protocol violator in the participated study prior to participation in this study
A Study Of A Novel Compound For Excessive Daytime Sleepiness Associated With Narcolepsy

Histaminergic agents are known to be involved with the sleep/wake cycle. This compound is a histaminergic agent which therefore may improve alertness and awakeness in patients with excessive daytime sleepiness (EDS) associated with narcolepsy. Significant improvement in EDS when treated with this compound compared to placebo in patients with narcolepsy is hypothesized.


Eligibility Criteria:
Inclusion Criteria:

* ISDC diagnosis of narcolepsy
* Excessive Daytime Sleepiness in association with a diagnosis of narcolepsy
* An MWT (Maintenance of Wakefulness Test) average sleep latency of under 15 minutes at Baseline

Exclusion Criteria:

* No other diagnosed sleep disorders (e.g., sleep apnea)
* Major medical disorders
* Major psychiatric disorders
A Study of Clinical Outcomes of the REALIZE Adjustable Gastric Band-C

The purpose of this study is to evaluate the results patients are obtaining with the Realize™ Adjustable Gastric Band-C during the first 24 months after surgery.


Eligibility Criteria:
Inclusion Criteria:

1. Received an implant with the Realize Band-C according to the following indications for use:

   1. Body Mass Index (BMI) of at least 40 kg/m2, or a BMI of at least 35 kg/m2 with one or more co-morbid conditions.
   2. Male and female adult patients (adult is defined as 18 years of age or older)
   3. Failed more conservative weight-reduction alternatives, such as supervised diet, exercise, and behavior modification programs.
2. Able to comprehend, follow, and give signed informed consent.

Exclusion Criteria:

1. Inflammatory diseases of the gastrointestinal tract, including severe intractable esophagitis, gastric ulceration or duodenal ulceration, or specific inflammation such as Crohn's disease;
2. Severe cardiopulmonary disease or other serious organic disease;
3. Upper gastrointestinal bleeding conditions such as esophageal or gastric varices or intestinal telangiectases;
4. Portal hypertension;
5. Anomalies of the gastrointestinal tract such as atresia or stenosis;
6. Cirrhosis of the liver;
7. Chronic pancreatitis;
8. Localized or systemic infection;
9. On chronic, long-term systemic steroid treatment or systemic steroids within 15 days of surgery;
10. Unable or unwilling to comply with dietary restrictions required by this procedure;
11. Known allergy to materials contained in the gastric band or its Injection Port;
12. Women who are pregnant;
13. Women at childbearing potential planning to get pregnant within 2 years or not using acceptable methods of contraception.
The Diagnostic and Prognostic Role of SAA in Intrathoracic Sarcoidosis

The goal of this observational study is to elucidate the role of serum amyloid A (SAA) in the diagnosis and follow-up of sarcoidosis, including its prognostic value. The main questions it aims to answer are:

* Whether, at the time of diagnosis, SAA is in correlation with other serum markers of granulomatous inflammation, interstitial disease and pulmonary fibrosis, lung function and radiologic characteristics of intrathoracic sarcoidosis,
* Whether increased serum concentrations of SAA at the time of diagnosis act as a prognostic marker of progressive granulomatous inflammation and pulmonary interstitial disease.

Patients will undergo standard diagnostic procedures for intrathoracic sarcoidosis, according to WASOG (World association of sarcoidosis and other granulomatous disorders) criteria. Two additional vials of blood will be taken at diagnosis and one vial at follow-up for serum processing and biomarker analysis.

Healthy blood donors will represent our group of healthy controls.


Eligibility Criteria:
Inclusion Criteria:

* Above 18 years of age
* Enrolled immediately after the first diagnostic workup and before any treatment was initiated.

Exclusion Criteria:

* Individuals with granulomatous disease that could not be unequivocally diagnosed as sarcoidosis were excluded, as well as patients with possible confounding other known systemic inflammatory illnesses, acute infection, patients on immunosuppressive drugs or immunotherapy and patients with active cancer.
Effect of Acute Dietary Supplementation With Grape Seed Extract on Aortic Stiffness, Arterial Pressure, and Blood Vessel Dilation in Collegiate Obese Individuals at Rest

This study investigated if elevated BP and aortic stiffness characterized in obese individuals are attenuated following acute grape seed extract supplementation. It is hypothesized that acute dietary supplementation with grape seed extract attenuates aortic stiffness, systolic blood pressure, diastolic blood pressure, mean arterial pressure, and total peripheral resistance and these effects are partially due to reductions in peripheral vasoconstriction

Twenty men (obese = 10; normal body weight (NBW) = 10) participated in this study. Effects of placebo (PL: 600 mg) and GSE (600 mg) on systolic blood pressure (SBP), diastolic blood pressure (DBP), mean arterial pressure (MAP), heart rate (HR), stroke volume (SV), cardiac output (Q), total peripheral resistance (TPR), and AoS were compared 2 h after ingestion of GSE or PL on different days, one week apart. Arterial blood pressure was measured using a sphygmomanometer from a brachial artery at the level of the heart on chair. HR and SV were continuously measured using a non-invasive device (Physio Flow). CO was calculated by HR X SV. TPR was calculated by MAP/CO.

Eligibility Criteria:
Inclusion Criteria:

* Obesity: body mass index (\>30), Normal body weight: body mass index (25-29)

Exclusion Criteria:

* cardiovascular diseases or consume any antihypertensive medication or supplementation that can affect blood pressure or aortic stiffness