cyrilzakka/clinical-trials huggingface dataset:
Famvir for Treatment of Hearing in Unilateral Meniere's Disease

The specific aim of this study is to determine the efficacy of treatment with famciclovir in unilateral Meniere's Disease patients, specifically whether hearing can be improved. The investigators will determine the percentage of unilateral Meniere's Disease patients experiencing an absence of hearing fluctuation after 3 months of treatment with famciclovir as compared to the placebo arm.


Eligibility Criteria:
Inclusion Criteria:

* Unilateral Meniere's Disease
* 2 vertigo episodes of at least 20 minutes
* Fluctuating hearing by subjective history and/or audiometric documentation. Audiometric documentation is defined as affected ear pure-tone average change from an audiogram at Time 1 to Time 2 (less than one year apart) of greater than 15 dB.
* Less than 45 dB 4-frequency pure-tone average in the affected ear
* Tinnitus and/or aural fullness
* Willing to undergo the clinical trial procedures
* Signed informed consent

Exclusion Criteria:

* Acute or chronic middle ear disease in either ear
* Only hearing ear
* 4-frequency pure-tone average \> 45 dB in either ear
* Known allergy to famciclovir or any of the ingredients in the formulation
* Taking oral steroids or receiving IT steroids at time of enrollment. If the subject has been on oral steroids/IT steroids, 3 months must elapse from last dose to start of treatment in the study
* Must not have had previous inner ear surgery
* History of immunodeficiency diseases such as HIV
* History of renal insufficiency or other kidney diseases
* A female of child-bearing potential who is pregnant
* History of noncompliance to medical regimens
* Unwilling to or unable to comply with the protocol, including scheduling study evaluations
Evaluation of Stendo Pulsating Suit on Microcirculation and Central Blood Pressure in Essential Hypertension Patients

The action of one Stendo pulsating suit session will be evaluated on 24 patients referred to the hypertension consultations for essential hypertension treated but not stabilized. The effect of one Stendo pulsating suit session system will be mainly assessed on the peripheral cutaneous microcirculation and on the central arterial pressure.

The role of the endothelium in micro-vascular system is mediated by synthesis and release of numerous substances that act on the smooth muscle fibres. The release of these products is modulated, in turn, by various circulating molecules, by the autonomic nervous system and by local mechanical factors such as shear stress.

The essential hypertension is associated to increased risks of cardiovascular and stroke morbidity and mortality and constitutes a major cause of severe kidney failure. The essential hypertension is a complex and multi-factorial disease; the dysfunction of the endothelium is of a great importance in the physiopathology of this disease, concerning both the consequences of the increase of the blood pressure and the possible cause of the hypertension development.

The Stendo pulsating suit is expected to increase the cutaneous microcirculation measured by laser Doppler laser flowmetry and potentially to decrease the central blood pressure. Each patient will be his own witness and the clinical records will be assessed before, during when relevant, and after a pulsating suit session.

Eligibility Criteria:
Inclusion Criteria:

* Patient referred to the Hypertension Hospital Consultation for essential hypertension treated but not stabilized
* Patient with essential hypertension defined by a brachial arterial pressure of 140 ≤ Systolic Arterial Pressure \< 180 mm Hg and/or 90 ≤ Diastolic Arterial - Pressure \< 110 mm Hg
* Essential Hypertension confirmed by an ambulatory measure of the arterial pressure during 24 hours before the pre-inclusion visit
* Patients aged more than 40 and less than 70

Exclusion Criteria:

* Patient with secondary hypertension
* Patient with diabetes
* Patient with complete arrhythmia with atrial fibrillation
* Patient with an advanced obstructive arterial disease
* Patient with a recent and progressive deep venous thrombosis
Comparison of Treatments for Barrett's Esophagus With High-Grade Dysplasia/Early Adenocarcinoma

Prospective randomized study comparing radiofrequency ablation and cryotherapy for the endoscopic treatment of Barrett's esophagus. The study is powered to assess clinical equivalence (non-inferior) of the treatment regimens.

Adult patients found to be suitable candidates for endoscopic treatment of Barrett's esophagus (BE) with high-grade dysplasia (HGD) and/or early adenocarcinoma of the esophagus will be asked to participate in this study. Patients will be randomized to receive either radiofrequency ablation or cryotherapy. All treatments will be performed using standard MGH GI Unit protocol. A total of fifty subjects will be enrolled.

Patients who have contraindications to endoscopic treatment (e.g., bleeding diathesis, pregnancy, severe medical comorbidities, advanced liver disease) or who decline participation in the study will be ineligible. Patients unable to provide their own consent will also be excluded.

This is a single-site study to be conducted at MGH.

After obtaining written informed consent, the patient will be randomized to receive either radiofrequency ablation or cryotherapy. Treatments will be carried out in accordance with standard MGH GI Unit practice. The primary endpoint of the study is the percentage of Barrett's esophagus ablated at the first follow-up visit (typically 2-3 months following therapy). At this point, the patient's role in the study will be terminated. They will continue to receive routine follow-up by their physician as needed.

Eligibility Criteria:
Inclusion Criteria:

* suitable candidates for endoscopic treatment of Barrett's esophagus (BE) with high-grade dysplasia (HGD) and/or early adenocarcinoma of the esophagus

Exclusion Criteria:

* contraindications to endoscopic treatment (e.g., bleeding diathesis, pregnancy, severe medical comorbidities, advanced liver disease)
* refusal to participate in the study
Improving the Intraoperative Diagnosis Accuracy of Invasiveness for Small-sized Lung Adenocarcinoma

The goal of this observational study is to improve the intraoperative diagnosis accuracy of invasiveness for small-sized lung adenocarcinoma by combining multi-modal information. The main question it aims to answer is whether multi-modal information have great value of prediction on the invasiveness for small-sized lung adenocarcinoma. Since a promising limited resection is largely based on intraoperative frozen section diagnosis, there is a growing demand on the high-accuracy of timely pathology diagnosis. The multi-modal information of participants will be collected retrospectively.


Eligibility Criteria:
Inclusion Criteria:

CT examination within 3 months before surgery Patients with operable clinical stage I lung cancer No previous treatment in the lungs or any other organ

≥ 20 years and ≤ 80 years old Tumor less than 3cm in diameter on thin-slice (0.625-1 mm) CT images Lung adenocarcinoma confirmed by surgical resection and histopathological diagnosis

Exclusion Criteria:

Marked artifacts on CT images History of preoperative treatment Incomplete clinical information or DICOM images History of other malignant tumors Lung cancer associated with cystic airspaces
Ultrasound-Guided Vascular Puncture and Catheterization

To assess and improve the safety and success rate of vascular puncture and catheterization using ultrasound-guided methods.

Investigators hypothesized that （1） various ultrasound-guided methods had different performances of vascular puncture and catheterization, (2) certain risk factors influenced safety and success rate of vascular puncture and catheterization (3) implementation of protocols could improve the performances of ultrasound-guided vascular puncture and catheterization.

Eligibility Criteria:
Inclusion Criteria:

* Age above 18 years old.
* Scheduled for selective surgery.
* Requirement of perioperative vascular puncture and catheterization.
* American standard of anesthesia level I-IV.

Exclusion Criteria:

* Contraindication to vascular puncture or catheterization.
* Occlusion or thrombosis of target vessel evaluated by ultrasound.
* Refuse or disagreement from participants.
Open-label, Randomized Trial to Determine the Effect of Icodextrin Versus Dextrose (Dianeal 2.5%) in HOMA IR

Phase IV post-marketing study to evaluate the effect of Extraneal on the HOMA index in non-diabetic CAPD patients over the long-dwell exchange. The purpose of the study is to investigate if the use of Extraneal (which is a mixture of high weight glucose polymers), instead of glucose-based solutions such as Dianeal is going to lower the HOMA index in non-diabetic CAPD patients.


Eligibility Criteria:
Inclusion Criteria:

* must be over 18-years old and under 75-years old
* Peritoneal Equilibration Test (PET) result of high, high average or low average transport
* non-diabetic patient
* be in Continuous Ambulatory Peritoneal Dialysis (CAPD)
* prevalent patients that have been in peritoneal dialysis at least 30 days
* wish to participate

Exclusion Criteria:

* Have a Charlson score of \>7 and have a life expectancy of less than 12 months
* HIV positive
* present with peritonitis in the month prior to randomisation
* present with cardiovascular, metabolic or infection complications that have required hospitalisation in the month prior to the randomisation
* have active cancer
* pregnant women
* patients with known allergy to starch-based polymer
* patients who have a significant psychiatric disorder or mental disability that could interfere with the patient´s ability to provide Informed Consent and comply with the protocol procedures
* women incapable of maintaining an effective and accepted contraception method
Adipocytokines and Polycystic Ovary Syndrome (PCOS)

Inflammation may play a role in the development of polycystic ovary syndrome (PCOS). In this study, the investigators investigated the expression of different mediators of inflammation in fatty tissue and in blood in women with and without PCOS.


Eligibility Criteria:
Inclusion Criteria:

* Women with PCOS were included according to the Rotterdam diagnostic criteria for PCOS. Control women met none of the criteria for PCOS

Exclusion Criteria:

* Oc´s within the last three months, or other medication known to alter glucose/insulin metabolism
* Other known chronic diseases
Early Care After Discharge of HF Patients

After decompensated heart failure, a number of patients have high risk of early rehospitalization as well as death. Specialized medical management for a short period but very early after discharge could be critical for optimizing care and improving early outcome.

This study aims to compare such early intensive medical management with usual care in high-risk patients after discharge.

At discharge, high-risk HF patients are selected and randomized in two groups:

* Control group: usual disease management according to guidelines and including first medical consultation and biological test within the 4-week time following discharge.
* Active group: consultations with HF specialist including biological test at weeks 1, 2 and 4 are planned in addition to usual management.

Eligibility Criteria:
Inclusion Criteria:

* 18 years or more
* consent signed
* Acute or decompensated heart failure with one or more of following criteria::

  * Discharge BNP \> 350 pg/ml or NTproBNP \> 2200 pg/ml
  * Discharge serum creatinine ≥ 180µM
  * Discharge systolic blood pressure ≤ 110mmHg
  * Previous hospitalisation for acute heart failure \< 6 months

Exclusion Criteria:

* acute coronary syndrome,
* acute myocarditis,
* isolated right HF,
* transient HF,
* planned cardiac surgery,
* high risk of short-term non-cardiac death,
* planned management within rehabilitation center/HF clinic at discharge
Ovulation Trigger With hCG Compared to GnRH Agonist in Patients With Repeated IVF Failures

Ovulation trigger is needed in in vitro fertilization (IVF) to get mature eggs. Routinely, human chorionic gonadotropin (hCG) is used for that purpose given its similarity to the natural hormone that does this job in a natural cycle (luteinizing hormone, LH). In a natural cycle another hormone takes part in the process (follicle stimulating hormone, FSH). To induce a natural-like ovulation surge that includes LH and FSH , gonadotropin releasing hormone (GnRH) agonist can be given.

The purpose of this study is to find out which approach may work better in IVF patients who experienced 4 IVF failures.


Eligibility Criteria:
Inclusion Criteria:

* IVF patients with at least 4 consecutive failures.
* On trigger day, no more than 10 follicles of 12 mm and up

Exclusion Criteria:

* History of moderate or severe OHSS.
Interstitial Cystitis and Urinary pH

This is a pilot study to assess the correlation between urinary pH and Interstitial Cystitis (IC) pain, with emphasis placed on exploring the type and severity of pain.

Subjects who agree to participate in the study will meet with a research team member who will review the study with them, obtain informed consent sign the HIPPA form, and provide study materials (void diary for urine quantification and recording of IC symptoms, pH strips to dip urine, "hat" to measure urine). Medical charts will be reviewed to determined how Interstitial Cystitis was diagnosed, medications, medical/surgical history, and demographics such as weight, height, BMI, race, age, marital status, education, insurance, tobacco or alcohol use. Subjects will need to dip pH paper into the urine and specific gravity reagent strip, and, by color comparison between the strips and the corresponding scales, determine and record urine pH and specific gravity. They will need to fill out the corresponding section in the voiding diary that is a survey to type and severity or pain as well as other symptoms of IC. The research team member will teach the subject how to measure the volume of their urine and how to measure and record specific gravity and pH. When not practical to record the volume of the urine (when patients are at work or away from home) they will still be asked to record pH, specific gravity and experienced symptoms. Subjects will be asked to perform the above described protocol with each episode of micturition for 3 days.

After enrollment, subjects will complete the O'Leary-Sant pain (symptom and problem index) questionnaire, if subjects have a combined score greater than or equal to 12 they are considered to have problematic or symptomatic IC. The voiding diary that include pH and specific gravity measurement measurements, times, volume, and survey of symptoms will be returned 1-2 weeks following completion of 3 day void diary for a face-to-face meeting with a research team member. Attempts will be made to have those meetings coincide with a clinical visit to minimize study burden to the subject(e.g. - at the time of cystoscopy or follow-up visit. )

Eligibility Criteria:
Inclusion Criteria:

* Women aged 18-70, with diagnosed Interstitial Cystitis (IC) and bladder pain present during week preceding enrollment.

Exclusion Criteria:

* Subjects who are pregnant. Subjects with current UTI or are unwilling/unable to provide consent.
Phase 1 Pharmacokinetics, Safety, and Tolerability Study

A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Ascending Single and Multiple Oral Dose Study of the Pharmacokinetics, Safety, and Tolerability of XG005 in Healthy Volunteers.

This is a randomized, double-blind, placebo-controlled study which will investigate the PK, safety, and tolerability of four ascending single and multiple oral doses of XG005 in healthy subjects. The trial consists of two parts: a single ascending dose (SAD) PK evaluation (Part 1) and a multiple ascending dose (MAD) PK evaluation (Part 2). Approximately 32 Subjects will be enrolled sequentially into a total of 4 ascending dose levels in each part.

Eligibility Criteria:
Inclusion Criteria:

1. Healthy males or females between 18 and 55 years of age
2. BMI 18.0 to 30.0 kg/m2
3. Non-pregnant, non-breastfeeding female subjects

Exclusion Criteria:

1. Unstable or severe illness
2. History of, or current treatment for, GI disease
3. Clinically significant history of medical condition associated with GI events
4. History of or current glucose intolerance or gestational diabetes
5. Lifetime history of suicidal behavior
6. Creatinine clearance \< 90 mL/min
7. Any elevation of liver function tests
8. Creatine kinase (CK) value of greater than 1.5 times the upper limit
9. Leucocytes or lymphocytes less than 1.5 times the lower limit of normal
10. Positive Hepatitis B surface antigen, HCV, or HIV
A Single Dose Trial of Recombinant Factor VIII (N8) in Japanese Subjects With Haemophilia A: An Extension to Trial NN7008-3543

This trial is conducted in Japan. The aim of this clinical trial is to investigate the pharmacokinetics (the effect of the investigated drug on the body) and safety of turoctocog alfa (recombinant factor VIII (N8)) in Japanese subjects with haemophilia A.


Eligibility Criteria:
Inclusion Criteria:

* Japanese subjects who have completed NN7008-3543
* No detectable inhibitors to factor VIII

Exclusion Criteria:

* Congenital or acquired coagulation disorders other than haemophilia A
* Planned surgery during the trial period
* Receipt of any investigational drug other than recombinant factor VIII (N8) within 30 days of trial product administration
Treatment of Severe Limb Ischemia With Autologous Bonemarrow Derived Mononuclear Cells

The aim of the study is to investigate whether implantation of autologous bone marrow derived stem cells in ishemics limbs will improve vascularization

10 patients with severe lower limb ischemia will be included in this pilote trial.

Bonemarrow aspiration will be performed and and the monocuclear cells isolated an injected into the gastrocnemius.

The patiens are followed for 4 months. Were trancutaneous oxygenpressure, ankel and toe blood pressure is measured.

Eligibility Criteria:
Inclusion Criteria:

* Ankle blood pressure \< 70 mmgHG
* Either pain at rest and/or ischemic wound
* No possible surgical treatment

Exclusion Criteria:

* Infection
* Malignant disease
Project WERK (Wellness Encouragement Respect Kinship)

The Project WERK intervention is a brief, theory based and culturally sensitive intervention designed to capitalize on organic yet underutilized social support networks in the lives of young black men who have sex with men (YBMSM). The intervention has been developed with input from clients and their support network members, case managers, social workers, primary care providers. The goal of the intervention is to improve retention in PrEP care for young Black MSM.

Project WERK will recruit, consent and randomize 160 men, with 80 men randomized to each arm of the study. Men randomized to the control condition will receive standard PrEP care at each clinical site. Men randomized to the experimental condition will receive standard PrEP care and also will be asked to recruit a supportive contact from their social network. The support contact will then be engaged in a brief intervention designed to support their friend/family member around PrEP Care. Men and support contacts in the WERK intervention also will receive booster sessions via telephone and text. All participants will complete surveys at baseline and at three and twelve months post intervention.

Eligibility Criteria:
Inclusion criteria

Index subjects:

* Self-identify as African American/Black;
* Assigned male sex at birth;
* Any same gender anal or oral sex in the past 2 years;
* English speaking;
* Have at least one support contact in their network;
* Own a cell phone not shared with other persons;
* Between the ages of 18-35 years old; and
* Have had fewer than 3 PrEP clinical visits in the past 12 months.

Support Contact:

* Index participant has agreed to including the support contact
* Willing to attend face to face and telephone mini-booster sessions;
* 18 years of age or older;
* English speaking; and
* Owns a cell phone that is not shared with other persons.

Exclusion Criteria

Index Subject:

* Unable to provide informed consent;
* Plan to move out of the area within the next 12 months;
* Are not willing to attend intervention sessions; or
* Not willing to return for assessments.

For index participants without a support contact, we will refer them to an appropriate support group for PrEP.

Support Contact:

* Romantic partner of index participant;
* Unable to provide informed consent;
* Plan to move out of the area within the next 12 months;
* Are not willing to attend intervention sessions; or
* Not willing to return for assessments.
Treatment of Ano-perineal Fistulas Resistant to Surgical Treatment with a Gel and Plug of Wharton's Jelly

The purpose of this open, multicenter pilot trial is to evaluate the tolerance of the combination of a gel and a plug made of Wharton's jelly in the treatment of ano-perineal fistulas resistant to surgical treatment.


Eligibility Criteria:
Inclusion Criteria:

* Male or female, aged 18 to 65 years.
* Patient with a single anal fistula resistant after at least one surgical treatment. Fistula may be related to Crohn's disease.
* Patient with an upper transsphincteric or lower transsphincteric fistula.
* Patient presenting fistula with or without intersphincteric diverticula.
* Fistula effectively drained with a seton.
* Informed and consenting patient.
* Patient who is a member or a beneficiary of a national health insurance plan.

Exclusion Criteria:

* Pregnant or breastfeeding woman or woman of childbearing age without effective contraception.
* Patients who have had more than one failed obstruction technique.
* Patient with more than one internal orifice.
* Patient with an MRI proven abscess.
* Patient with an uncontrolled infection.
* Patient with a contraindication to anesthesia.
* Person deprived of liberty by a judicial or administrative decision.
* Adult subjected to a legal protection measure or unable to express his / her consent.
Studies of Neuregulin/ERBB Signaling in Human Heart

This study examines the role of the epidermal growth factor (EGF) receptor family and the EGF family of ligands in the regulation of non-myocytes isolated from the human heart.

The EGF family of receptor tyrosine kinases (a.k.a. ERBB receptors) mediate the effects of the epidermal growth factor (EGF) family including Neuregulin-1β (NRG). NRG and ERBB1-4 are critical for cardiac development and maintenance of the adult heart. Current understanding of the role of EGF/NRG/ERBB signaling in the cardiovascular system is rapidly evolving due to recent findings in non-myocyte cell populations. This study is examining a population of progenitor cells in the adult human heart that responds to EGF and NRG. Subjects are enrolled who are scheduled to undergo heart surgery and are willing to allow for a small biopsy to be taken from their hearts during surgery. Biopsies are taken to the laboratory where cells are separated and analyzed by flow cytometry and grown in cell culture to understand how their biology is regulated by NRG and EGF.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of severe coronary artery disease scheduled to undergo coronary artery bypass surgery.

Exclusion Criteria:

* less than 18 years of age
* unwilling or unable to provide informed consent
* known active myocarditis
* hypertrophic cardiomyopathy
* constrictive pericarditis or other significant pericardial disease
* severe pulmonary hypertension
* significant renal impairment (Cr \> 2.5 mg/dL)
* severe ventricular arrhythmias
* pregnancy