cyrilzakka/clinical-trials huggingface dataset:
Nutritional Restriction and Activity Thermogenesis

These studies will provide us with enormous insight regarding how obese patients adapt energetically during negative energy balance. We will gain fundamental information regarding the metabolic implications of combining food restriction with a walking program compatible to that advocated by statutory agencies. These studies will lead to improved understanding of the energetic adaptation that occurs during negative energy balance and how best to treat patients with obesity.


Eligibility Criteria:
Ninety sedentary subjects, aged 25-55, who live \<10 miles from Rochester will be recruited. This age range has been selected to enable us to study individuals at the peak age-range of obesity and over-weight prevalence and to avoid issues of menopause. Subjects will not be eligible for consideration if they take two or more bouts of exercise/week or participate in sports for more than 2 hours/week. Subjects with predicted weight maintenance energy requirements of \<2000 kcal/day will have been excluded at screening. This is because when we come to underfeeding by 1000 kcal/day, we want to avoid feeding any volunteer \<1000 kcal/day, for safety \& compliance reasons.

(A) LEAN: 30 (15F,15M) lean subjects; BMI \<25 kg/m2. Each lean subject will be individually matched for height (+3cm) and age (+3 years) to an obese subject so as to establish comparable groupings for body size. Subjects will have been weight-stable for six months (B) OBESE: 30 (15F,15M) obese subjects; BMI 30-35 kg/m2. Subjects will have been weight-stable for six months (C) POST-OBESE: 30 (15F,15M) patients will have had a previous BMI \>30 kg/m2 and a weight loss sufficient to achieve a BMI of \<26 kg/m2 maintained for at least 2 months (with weight fluctuation during this period of \<1 kg) (94). We will attempt to match these subjects to the obese subjects as described above.
Value of Penile Elastography in Diagnosis of Patients With Erectile Dysfunction and Non-responders to Intra-corporal Injection

Penile erection is a neurovascular response that induces penile arterial dilatation, increased blood flow, and cavernous smooth muscles (CSM) relaxation; the enlarging corpora cavernosa compress the subtunical veins, against a rigid tunica albuginea, and entrap blood within the penis. Impaired CSM function can result in corporo veno-occlusive dysfunction (CVOD) and erectile dysfunction. Nevertheless, diagnostic tests, which can evaluate the status of CSM, are not clinically applicable. Penile elastography is a new promising tool that can assess the stiffness of the corpora cavernosa. Accordingly penile elastography can assess the status of the cavernous tissue and can distinguish patient with corporal fibrosis.


Eligibility Criteria:
Inclusion Criteria:

* For group 1: Patients (age ≥ 21) have established sexual relationship for at least 3 months. These patients are complaining of ED and not responding to intracorporal injections (ICI).
* For group 2: Men (age ≥ 21) have an established sexual relationship for at least 3 months. These men have normal erectile function.

Exclusion Criteria:

* Peyronnie's disease, post-priapism corporal fibrosis, and clinically detected post traumatic corporal fibrosis, previous ICI therapy, history of penile and/or urethral surgery, liver cell failure, renal failure, heart failure, endocrinal diseases (e.g. thyroid- Adrenal), medications that may cause ED, and neurologic and psychotic disorders.
Detrusor Underactivity and Bladder Outlet Obstruction in Women With Cystocele

Women with cystocele may be associated with detrusor underactivity (DU) or bladder outlet obstruction (BOO). However, the impact of cystocele repair on the rates of DU and BOO remained obscure. Thus, the aim of this study was to elucidate the prevalence of DU and BOO in each age group and elucidate the impact of cystocele repair on the rates of DU and BOO.

Between November 2010 and September 2018, all women with ≥ POP-Q stage II cystocele who visited the urogynecological department of a medical center for urodynamic evaluation were reviewed. Those women who have no complete data of maximum flow rate (Qmax), voided volume, post-void residual volume (PVR) and detrusor pressure at a maximum flow rate (PdetQmax) were excluded from this study. The DU was defined when the PdetQmax was less than 20 cmH2O, the Qmax was less than 15 mL/s, and the bladder voiding efficiency (BVE) was less than 90 %. The BOO was defined when the PdetQmax was not less than 40 cmH2O, and the Qmax was less than 12 mL/s. BVE = voided volume / (voided volume+ PVR) x 100%. Those women without DU or BOO were allocated to the non-DU/BOO group.

STATA software was used for statistical analysis. Wilcoxon signed-rank test or McNemar's test was used for statistical analysis as appropriate. P \< 0.05 was considered statistically significant.

Eligibility Criteria:
Inclusion Criteria:

* ≥ POP-Q stage II cystocele
* Female

Exclusion Criteria:

* Those women who have no complete data of maximum flow rate (Qmax), voided volume, post void residual volume (PVR) and detrusor pressure at maximum flow rate (PdetQmax) were excluded from this study.
Esomeprazole Treatment for Patients With Lymphocytic Gastritis

The purpose of this study is to determine whether treatment with esomeprazole alone is able to heal patients with lymphocytic gastritis

Recently, a placebo controlled trial of our group has shown that H. pylori eradication therapy consisting of omeprazole 20 mg bid, clarithromycin 500 mg bid, amoxicillin 1000 mg bid for seven days leads to a complete long-lasting resolution of lymphocytic gastritis in 96 % of patients. However, after 3 months we also found a healing rate of 50 % in patients who received omeprazole 20 mg bid and placebo antibiotics for seven days suggesting spontaneous remission or a potential PPI effect. Thus, we speculate that PPI therapy may have led to elimination of H. pylori and subsequently healing of lymphocytic gastritis in those patients with potentially minimal H. pylori colonization at baseline. For this reason we investigate whether a PPI treatment alone is able to heal patients with lymphocytic gastritis.

Eligibility Criteria:
Inclusion Criteria:

* Histologically proven lymphocytic gastritis (IEL \> 25/100)
* Male or female aged 18 years or older
* Signed and written informed consent

Exclusion Criteria:

* Regular NSAID or aspirin intake
* Concomitant medication with antibiotics, bismuth subsalicylate, aminosalicylates
* Regular PPI therapy
* Treatment with ketoconazole or other CYP3A inhibitors
* previous surgery of the stomach
* known or suspected hypersensitivity to esomeprazole
* Malignant diseases
* Concomitant severe diseases
* Pregnancy or lactation
* Contraindication to take biopsies (Quick \< 50%, PTT \> 50 s, thrombocytes \< 100.000/mm3)
Efficacy and Safety of Intravenous Ferric Carboxymaltose (FCM) in Patients With Iron Deficiency Anemia (IDA)

The main objective of this study is to demonstrate the efficacy and safety of an investigational intravenous (IV) iron, ferric carboxymaltose (FCM), compared to oral iron in subjects who have iron deficiency anemia (IDA) and have shown an unsatisfactory response to oral iron.


Eligibility Criteria:
Inclusion Criteria:

* Male or female subjects ≥ to 18 years of age and able to give informed consent.
* Diagnosis of Iron Deficiency Anemia (IDA).
* Hemoglobin (Hgb) ≤ to 11 g/dL.
* Ferritin ≤ to 100 ng/mL or ≤ 300 when Transferrin Saturation (TSAT) was ≤ 30%.
* Must demonstrate an unsatisfactory response or intolerance to oral iron.

Exclusion Criteria:

* Known hypersensitivity reaction to any component of ferric carboxymaltose or ferrous sulfate.
* Previously randomized in a clinical study of Ferric Carboxymaltose (FCM).
* Requires dialysis for treatment of chronic kidney disease.
* No evidence of iron deficiency.
* Any non-viral infection.
* AST or ALT at screen 1, as determined by central labs, greater than 1.5 times the upper limit of normal.
* Known positive hepatitis with evidence of active disease.
* Received an investigational drug within 30 days of screening.
* Alcohol or drug abuse within the past 6 months.
* Hemochromatosis or other iron storage disorders.
* Estimated life expectancy of less than 6 months or, for cancer patients, an ECOG Performance Status greater than 1.
* Any other laboratory abnormality, medical condition, or psychiatric disorders which in the opinion of the investigator would put the subject's disease management at risk or may result in the subject being unable to comply with study requirements.
* Pregnant or sexually-active females who are of childbearing potential and who are not willing to use an acceptable form of contraception.
Fidaxomicin to Prevent Clostridium Difficile Colonization

The purpose of this research study is to evaluate the effectiveness of an antibiotic called fidaxomicin in preventing C. difficile infection.

A novel approach to prevent C. difficile infection is to use compounds with activity against C. difficile as primary prophylaxis in high risk patients. Chemoprophylaxis theoretically can prevent C. difficile infection by two mechanisms. It may reduce transmission from asymptomatic C. difficile carriers by reducing the number of spores shed in the stool and prevent replication and subsequent toxin production of the organisms in patients at risk for C. difficile infection.

Eligibility Criteria:
Inclusion Criteria:

* ≥ 18 years old
* On broad spectrum antimicrobials
* Anticipated length of stay of \> 48 hours after enrollment
* A non-ICU inpatient

Exclusion Criteria:

* Pregnant
* Expected to die within 7 days
* Have previously been enrolled in this trial or a trial of an investigational agent to treat CDI, and/or are on monotherapy with an antimicrobial generally considered not to increase the risk of CDI (vanc, macrolides, tetracyclines, trimethoprim/sulfamethoxazole, aminoglycosides, colistin, linezolid, nitrofurantoin, metronidazole)
Maternal and Fetal Adrenocorticotropic Hormone (ACTH) and Leukemia Inhibitory Factor (LIF) and Gestational Age

In 2010, Simamura et al have demonstrated in a rat model that one of the pro-inflammatory cytokine belonging to the Interleukin-6 family cytokines, LIF, is required for the proliferation of neuronal progenitor cells in the cerebrum. They have shown that maternal LIF induces ACTH from the placenta, which in turn stimulates fetal nucleated red blood cells to secrete LIF, leading finally to neurogenesis in the fetus As demonstrated recently in a mouse model, maternal inflammation suppress the physiological maternal- fetal LIF-ACTH-LIF signal, result in reduction of ACTH production from placenta, which lead to a reduction in LIF concentration in fetal Cerebrospinal fluid (CSF) and impaired proliferation of the neural stem/ progenitor cells and poor development of the fetal brain.

In the current study, the investigators will take fetal and maternal blood samples of fetuses undergoing termination of pregnancy (TOP) . Maternal samples will be acquired with the routine blood samples before performance of TOP , fetal blood samples will be acquired from the umbilical vessel after the termination has been completed , the blood samples will be analyzed for levels of LIF and ACTH and checked according to termination pregnancy week, Patients electronic files will be checked for relevant demographic and obstetric information.

Study protocol:

In the current study, the investigators will take fetal and maternal blood samples of fetuses undergoing termination of pregnancy (TOP) . Maternal samples will be acquired with the routine blood samples before performance of TOP , fetal blood samples will be acquired from the umbilical vessel after the termination has been completed , the blood samples will be analyzed for levels of LIF and ACTH and checked according to termination pregnancy week, Patients electronic files will be checked for relevant demographic and obstetric information.

Eligibility Criteria:
Inclusion Criteria:

* Pregnant women undergoing termination of pregnancy in various gestational weeks.
* Pregnant women undergoing spontaneous abortion.

Exclusion Criteria:

•Intrauterine fetal death.
Primary Palliative Care in Heart Failure: A Pilot Trial

Patients with advanced heart failure (HF) typically experience significant burdens that negatively impact their quality of life. Although palliative care has been shown to improve patient outcomes in other serious illnesses, insufficient data exist to support its use in HF. Furthermore, the demand for palliative care in serious illness outstrips the available supply of certified palliative care clinicians. This pilot trial will assess the feasibility and acceptability of training cardiology nurses in basic palliative care skills and their ability to deliver this care alongside usual HF management.

Patients with advanced heart failure (HF) suffer from significant pain, fatigue, difficulty breathing, anxiety, and depression. Palliative Care (PC) is a medical specialty designed to focus on relieving patient suffering by providing an extra layer of support on top of usual care. To date, there has been little research on the impact of PC in HF. We will conduct a randomized clinical trial to assess the feasibility, acceptability, and perceived effectiveness of training cardiology nurses in PC and administering PC to their patients. Patients will be randomized into either the usual care group or the intervention group. Usual care participants will receive their care with no alterations, and intervention participants will receive the PC intervention from their nurse on top of their usual care. Both groups will complete health-related surveys on tablet computers, via email, and/or via telephone. In the intervention group, these answers will be used to tailor the intervention to the specific patient's needs. Caregivers will also be recruited into the study, and will complete surveys similar to the patients via the aforementioned methods.

Eligibility Criteria:
Inclusion Criteria:

* New York Heart Association Class III or IV Heart Failure
* 2 or more hospitalizations in the past year due to Heart Failure

Exclusion Criteria:

* Less than 40 years old
* Currently awaiting a transplant
* Received outpatient palliative care within the past 12 months
* Pregnant or intends to be within the next 12 months
* No regular phone access
* Not fluent in English
* Failed the Callahan 6-item Screener
* Does not intent to regularly attend clinic for the next 12 months
Early Feasibility Study (EFS) Laplace Transcatheter Tricuspid Valve Replacement (TTVR) System

The objective of the study is to assess the safety and technical feasibility of the Laplace Transcatheter Tricuspid Valve Replacement (TTVR) System

Early Feasibility (EFS), prospective, single-arm, multi-center study to evaluate safety and technical feasibility of the Laplace TTVR System in the treatment of severe, symptomatic tricuspid regurgitation patients.

Eligibility Criteria:
Inclusion Criteria:

1. 22 - 90 years of age at the time of the study procedure
2. Symptomatic tricuspid regurgitation despite being adequately treated with optimal medical therapy by the Local Heart Team for at least 30 days prior to the time of study consent.
3. Severe, massive or torrential tricuspid regurgitation determined by qualifying transthoracic echocardiogram (TTE) and/or transesophageal echocardiogram (TEE) using the 5-grade classification.
4. Candidate felt suitable for transcatheter tricuspid valve replacement as determined by the local heart team and confirmed by the patient selection committee. For patients with pre-existing trans-tricuspid pacemaker or ICD leads, the local heart team shall include an electrophysiologist.
5. Subject or legally authorized representative has provided informed consent and agrees to return for all required post-procedure follow-up visits

Exclusion Criteria:

1. Estimated life expectancy of less than 12 months
2. PVR \>5 Wood units
3. Echocardiographic evidence of severe right ventricular dysfunction
4. Severe aortic, mitral and/or pulmonic valve stenosis and/or regurgitation requiring treatment
5. Presence of significant congenital heart disease including but not limited to hemodynamically significant atrial septal defect, RV dysplasia, and arrhythmogenic RV.
6. Any percutaneous cardiovascular intervention, cardiovascular surgery, or carotid surgery, within last 30 days. Implant or revision of any rhythm management device (CRT or CRT-D) or implantable cardioverter-defibrillator or leadless pacemaker within 90 days prior to the study procedure
7. Stroke or other major cerebrovascular event within 90-days prior to index procedure
8. Untreated clinically significant coronary artery disease requiring revascularization, recent (within last 30 days) acute coronary syndrome or myocardial infarction.
9. Bleeding disorders including thrombocytopenia or platelet count \<70,000 mm3 or thrombocytosis (platelet count \>700,000 /mm3)
10. Current or planned pregnancy within next 12 months for women of childbearing potential
11. Active or recent endocarditis within last 90 days or, sepsis/ other systemic infection requiring oral or intravenous antibiotics within last 30 days
12. Presence of other anatomic or comorbid conditions, or other medical, social, or psychological conditions that, in the investigator's opinion, could limit the subject's ability to participate in the clinical investigation or to comply with follow-up requirements. Any patient considered to be vulnerable.
13. Left ventricular ejection fraction (LVEF) \< 30%
Evaluating the Efficacy of Erector Spinae Block in Routine Hip Arthroscopy

The aim of this project is to evaluate the efficacy of preoperative erector spinae blocks in arthroscopic hip surgery. This will be a prospective randomized controlled trial.

The aim of this project is to evaluate the efficacy of preoperative erector spinae blocks in arthroscopic hip surgery. This will be a prospective randomized controlled trial. The control group will not receive a preoperative block prior to surgery, but will receive local anesthetic at the surgical site at the conclusion of the surgery. The study group will receive a preoperative block and local anesthetic. The primary outcomes will be pain levels and opioid consumption in the post-operative care unit. The secondary outcomes will be pain levels and opioid consumption post-operatively, and functional outcome measures.

Eligibility Criteria:
Inclusion Criteria:

* All patients undergoing hip arthroscopy for femoroacetabular impingement
* Ages 13-50
* Individuals who have the capacity to provide consent or assent for themselves

Exclusion Criteria:

* Hip arthroscopy for any other reason (not undergoing labral repair, acetabuloplasty, and femoral osteochondroplasty)
* Revision surgery
* Known narcotic use in the 6 months prior to surgery
* Workman's compensation patient
* Pregnancy
A Study to Assess the Safety and Efficacy of ZPL389 in Patients With Moderate to Severe Atopic Dermatitis

This was a randomized, double-blind, placebo-controlled, parallel-group study to assess safety and efficacy of ZPL389 in subjects with moderate to severe atopic dermatitis with a total study duration up to 24 weeks

A screening period of up to 4 weeks was followed by a 16-week double blinded treatment period.

After the end of treatment visit, subjects were offered the possibility of ongoing treatment in the extension study (CZPL389A2203E1/ NCT03948334), or of entering the 4 week treatment-free follow-up period.

Eligibility Criteria:
Inclusion Criteria:

* Subjects must give a written, signed and dated informed consent
* Chronic atopic dermatitis present for at least 1 year before Baseline
* Moderate to severe atopic dermatitis defined as per EASI, IGA and BSA.
* Documented recent history (within 6 months before the screening visit) of inadequate response to treatment with topical medications or for whom topical treatments are otherwise medically inadvisable
* Candidate for systemic treatment

Exclusion Criteria:

* Any skin disease that would confound the diagnosis or evaluation of atopic dermatitis disease activity
* Use of other investigational drugs within 5 half-lives of enrollment, or within 30 days or until the expected pharmacodynamic effect has returned to baseline, whichever is longer.
* History of hypersensitivity to any of the study drug constituents or to drugs of similar chemical classes.
* Participation in prior ZPL389 studies
Dose Escalation Study of KW-3902 on Diuresis in Subjects With Congestive Heart Failure (CHF).

The purpose of this study is to evaluate the safety of KW-3902IV compared to placebo and to determine the diuretic effect of KW-3902IV compared to placebo in patients hospitalized with volume overload due to CHF who are refractory to high dose diuretic therapy.


Eligibility Criteria:
Inclusion Criteria:

* History of CHF for greater than 3 months,
* Receiving oral/IV diuretic therapy
* Hospitalized for therapy for HF and edema that has not responded to diuretic therapy.
* Signs and symptoms of ongoing volume overload

Exclusion Criteria:

* Myocardial infarction in past 14 days
* Clinical evidence of acute coronary syndrome causing worsening of HF,
* Pregnant or breast-feeding,
* Severe, uncorrected primary valvular disease, constrictive pericarditis, restrictive or hypertrophic cardiomyopathy,
* Automated implanted cardiac defibrillator (AICD) or synchronization device implanted within the preceding 7 days,
* Require mechanical ventilation, ultrafiltration, or hemodialysis at the time of enrollment,
* Deterioration due to an acute or superimposed condition requiring therapy other than diuretics
* Symptomatic ventricular tachycardia,
* Severe concomitant primary hepatic disease,
* Severe pulmonary disease,
* Any other concomitant life-threatening disease,
* CVA in the preceding 6 months,
* Hypotension,
* Participated in another clinical trial within 30 days,
* Acute contrast nephropathy,
* Admitted for heart transplant surgery or have had a heart transplant.
Chinese Neonatal Extracorporeal Life Support Registry (Chi-NELS)

Extracorporeal life support (ECLS), also known as extracorporeal membrane oxygenation (ECMO), is an extracorporeal technique which provides respiratory and cardiac support to patients with respiratory and/or heart failure. Neonates account for a significant proportion of patients requiring ECLS support. While with unique pathophysiology among newborn infants, neonatal ECLS treatment faces different challenges (such as specific indications, anticoagulation, hemodynamic management, high incidences of complications, ect.) from those of elder children or adults. Though neonatal ECMO has been used in developed countries since 1970s, the introduction of neonatal ECMO in China was not reported until 2010s. While on the other hand, there has been a rapid increase of neonatal ECLS cases and centers in China in the past decade with a huge variation of numbers of cases and quality among different centers. Therefore, there is an urgent need to monitor the use and quality of neonatal ECLS in China. The goal of the Chinese Neonatal Extracorporeal Life Support Registry (Chi-NELS) is to maintain a registry of use of ECLS in active neonatal ECLS centers across China, to support quality improvement of neonatal ELCS, clinical research and regulatory agencies.

This study aims to establish a neonatal ECLS network of all active ECLS centers in China to facilitate standardization of care and collaborative research. On the basis of the network, this prospective comprehensive registry will enroll all neonates who receive ECLS support in participating centers. The indications, managements, complications and outcomes of neonatal ECLS in China will be described in detail, to monitor the development of neonatal ECLS in China, to identify targets for quality improvement, to assist in reducing mortality and morbidity of neonates requiring ECLS support, and to facilitate innovative clinical researches.

Eligibility Criteria:
Inclusion Criteria:

* ≤28 days of life
* receive ECLS support

Exclusion Criteria:

* none