cyrilzakka/clinical-trials huggingface dataset:
Prevacid vs Lifestyle Modifications for the Treatment of LPR

The purpose of this study is to evaluate changes in scores on the Reflux Finding Score and Reflux Symptom Index over a 24 week period. To enroll subjects must score at least a 13 on the Reflux Symptom Index and at least a 5 on the Reflux Finding Score. All subjects will receive education on lifestyle modifications with a nutritionist and exercise trainer. All subjects will be expected to comply with lifestyle modifications for the entire study period of 24 weeks. Half of all subjects will receive Prevacid 30mg BID and half will receive placebo BID for 24 weeks. Subjects will have 4 office visits over 24 weeks and weekly contacts with the study staff to assess Reflux Symptom Index and any health or medication changes.

The results of studies evaluating PPI therapy versus lifestyle modifications for the treatment of LPR have not been conclusive. However, many of these studies were conducted at tertiary care centers. We will look at patients presenting with LPR symptoms in a community setting. All subjects will have an exam of their larynx via laryngoscopy at each of the 4 study visits (screening, week 6, week 12, and week 24). Based on exam findings, the physician will complete the Reflux Finding Score. The subjects will also complete the Reflux Symptom Index weekly to assess for changes in their symptoms. The statistical analysis of this study will include evaluating changes in the Reflux Finding Scores and Reflux Symptom Index scores over the 24 weeks of study participation.

Eligibility Criteria:
Inclusion Criteria:

Symptoms of LPR for at least one month, Score of 5 or greater on Reflux Finding Score, Score of 13 or greater on Reflux Symptom Index, and Willing to follow lifestyle modifications.

Exclusion Criteria:

Currently taking PPI twice daily for the treatment of LPR, Women who are pregnant or lactating, History of duodenal or gastric ulcer in the past 5 years, erosive esophagitis, or esophageal obstruction, History of any hypersecretory condition, History of Barrett's esophagus, History of hematemesis in the past 6 months, Currently taking ketoconazole, digoxin, Iron, ampicillin, theophylline, warfarin, or sucralfate, or Suspected disease of the larynx not related to LPR.
Pharmacists Provide Telemedicine in Addition to Clinic Visits to Improve Diabetes Management

This prospective study will include both an intervention and control arm. The control arm will receive face-to-face pharmacy clinic visits per standard of care. The intervention arm will receive pharmacy clinic visits plus additional telephone follow-up. Patients with a hemoglobin A1c in the last 3 months greater than 9% will be eligible. Eligible patients must have a primary care physician at Johns Hopkins Outpatient Center (JHOC) or East Baltimore Medical Center (EBMC).

Purpose: To compare the change in hemoglobin A1c over the 3 month study period in the intervention group in which patients participate in telemedicine, to a control group in which they do not


Eligibility Criteria:
Inclusion Criteria:

* Adult patients with a primary care provider at JHOC or EMBC
* Patients have seen primary care provider within last 6 months
* Patients with hemoglobin A1c greater than 9%

Exclusion Criteria:

* Patients \<18 years of age
* Patients with previously established care with JHH ambulatory care pharmacist
* Patients with communication barriers who do not have a caregiver
* Patients with new diagnosis of diabetes
* Patients who are pregnant or planning to become pregnant during the time of the study
* Patients followed by Endocrinology or Diabetes Center
Ovarian Function and Reserve Parameters After Discontinuation of Long-term Use of Oral Contraception

The aim of this study is to investigate whether there is a correlation between anti-Müllerian hormone during long-term use of combined oral contraceptives and the recovery time before recovered menstrual cycle after discontinuation of oral contraceptives.

Background:

Hormonal contraception is widely used among women worldwide; 50-89% of all women in the Western countries use oral contraception at some point in their lives. Oral contraceptives (OC) suppress the hypothalamic-pituitary-ovarian axis through a negative feedback of ethinyl estradiol and progestins and thereby potentially influence the markers of ovarian reserve due to a suppressed release of gonadotropins, which will impair the growth of antral follicles.

Methods and Materials:

Participants for this studies will be included through the Fertility Assessment and Counseling Clinic, Rigshospitalet, Herlev- and Hvidovre Hospital.

Inclusion criteria: Use of oral contraception (for study 3 at least during the last three years).

Exclusion criteria: Known infertility, known thyroid disease.

Aims:

Study 3: Investigate the ovarian reserve markers after discontinuation of OC over a period of three months in women with a history of long-term OC use. The women will be followed with serial ultrasounds and blood samples and will complete a menstrual calendar.

Eligibility Criteria:
Inclusion Criteria:

* Minimum three years of oral contraceptives.

Exclusion Criteria:

* Known infertility, known thyroid disease.
Individual Response to Different Volumes of Resistance Training

The literature is not clear as to which training volume to employ during initial phases of resistance training programs to ensure optimal muscular adaptations. The purpose of this study is therefore to compare effects of strength training with low versus moderate volume on muscular function and hypertrophy in previously untrained, healthy individuals. Furthermore, the investigators will relate individual variation in responses to proxy markers of individual training state, such as baseline muscular function and muscle fiber type.

The study will include 25 women and 25 men and will consist of a 12-week resistance training protocol. Each study participant will act as their own control, performing both the low- (1-set) and the moderate-volume (3-sets) protocol, allocated to either the dominant or non-dominant leg, in a stratified and randomized fashion.

Primary outcome measures are thigh muscle cross section area and unilateral knee extension strength. Additionally, muscle fiber type composition will be evaluated as well as additional parameters of muscular function.

The primary hypothesis is that low-volume protocols will be beneficial for individuals with glycolytic muscle phenotypes, whereas the opposite will be true for individuals with more aerobic phenotypes.


Eligibility Criteria:
Inclusion Criteria:

* Healthy
* Non-smoking
* Able to tolerate resistance exercise training

Exclusion Criteria:

* Presence or history of cardiovascular, metabolic, endocrine or neuromuscular disease
* Diagnosed mental health disorder
* Intolerance to local anesthetic
* No experience with exercise training
* Performing regular resistance training (more than 1 session per week during last 12 months)
* Impaired strength/ neuromuscular function due to previous injury
* Recurrent pain in lower back, knee or shoulders
* Taking prescribed medication that may affect outcome of training intervention
Prostaglandin E2 as a Critical Mediator of Sex Disparities in Asthma

This study seeks to understand how biological sex influences airway hyperresponsiveness in adult asthma.


Eligibility Criteria:
Inclusion Criteria:

* Subject must be able to understand and provide informed consent
* Age 18-50
* A history of physician-diagnosed asthma well controlled as assessed by ACQ-6 \<1.5 and FEV1\>70% of predicted and FEV1 \>1.5 liters.
* Asthma must be persistent, defined by the requirement of a daily controller agent.
* Use of a stable dose of daily inhaled corticosteroids for the prior 3 months.
* Female subjects of childbearing potential must have a negative pregnancy test upon study entry and at each study visit.

Exclusion Criteria:

* Inability or unwillingness of a participant to give written informed consent or comply with study protocol.
* Hypogonadism, irregular menstrual cycles, polycystic ovarian syndrome (PCOS), exogenous hormonal supplements or contraception.
* Any chronic lung condition outside of asthma including chronic obstructive pulmonary disease (COPD), interstitial lung disease, eosinophilic granulomatosis with polyangiitis, allergic bronchopulmonary aspergillosis.
* Inability or unwillingness to hold the following medications prior to mannitol and methacholine inhalational challenge(s): Short-Acting Beta 2 Agonists \>8 hours, Inhaled Corticosteroids and Anticholinergic Bronchodilators \>12 hours, Phosphodiesterase Inhibitors or Adenosine Receptors \>24 hours, Long-acting Beta 2 Agonists \>36 hours, Long-acting Anticholinergics or Short-Acting Antihistamines \>48 hours, Long-Acting Antihistamines \>72 hours, and Leukotriene-Receptor Antagonist or 5-Lipooxygenase Inhibitors \>4 days.
* For males, a screening morning serum total testosterone level (obtained between 8-10 AM) below the normal reference lab value.
* Current pregnancy, breast-feeding, or plans to become pregnant during the study period.
* Oral or systemic corticosteroid use or biologic agent for asthma in the previous 3 months or ED/Hospitalization for asthma within 6 months.
* Use of investigational drugs within 12 weeks of participation.
* Known hypersensitivity or allergy to mannitol, gelatin or methacholine.
* Upper or lower respiratory tract infection within the proceeding 6 weeks.
* A history of uncontrolled hypertension, coronary artery disease, stroke, epilepsy, urinary tract obstruction, untreated thyroid disease, or a chronic lung disease other than asthma.
* Daily use of a beta-blocker.
* Intolerance to anticholinergic medications.
* Inability to produce an adequate sputum sample.
* Past or current medical problems or findings from physical examination or laboratory testing that are not listed above, which, in the opinion of the investigator, may pose additional risks from participation in the study, may interfere with the participant's ability to comply with study requirements or that may impact the quality or interpretation of the data obtained from the study.
Safety and Immunogenicity of Intradermal Versus Subcutaneous Doses of Menomune®

The objective of this trial is to study the administration of the Menomune vaccine given intradermally and low-dose subcutaneously versus standard subcutaneously. This study will describe the immunogenicity of Menomune® - A/C/Y/W-135 administered subcutaneously (standard dose) versus intradermally over a dose range (1/10th, 2/10th, and 3/10th of standard dose) and a low dose (2/10th of standard dose) subcutaneously.

The secondary objective is to describe the safety of the subcutaneous (SC) and intradermal (ID) routes at different dosages

This trial will provide a proof of concept that a dose range of Menomune given ID can induce an immune response that is comparable to standard dosing by the SC route, and is equivalent or superior to a low dose given SC.

Subjects will be randomized according to a computer-generated randomization schedule to receive the vaccine by SC injection or by ID injection at different dosages.

Eligibility Criteria:
Inclusion Criteria :

* 18 to 55 years of age.
* Willing to return for 3 follow-up visits and comply with a 30 day follow-up period.
* Signed an informed consent form.

Exclusion Criteria :

* Allergy to any component of the vaccine and latex.
* Known or suspected immunodeficiency or receipt of immunosuppressive therapy or blood products within the previous two months.
* History of serious chronic diseases (such as cardiac or renal disease).
* Acute febrile illness at the time of visit.
* Pregnancy.
* Receipt of any vaccine within the 28 days prior to enrollment.
* Receipt of meningococcal vaccine (example in Military) within the past 5 years or history of meningococcal disease.
Phase III Trial of Concurrent Chemotherapy Alone in Patients With Low-risk Nasopharyngeal Carcinoma

The purpose of this study is to compare concurrent chemoradiotherapy (CCRT) alone with induction chemotherapy (gemcitabine+cisplatin) plus CCRT in patients with low-risk locoregionally advanced nasopharyngeal carcinoma(NPC).

Patients with low risk NPC( Stage III-IVa, except T4N2/AnyTN3, AJCC 8th and EBV DNA \<4000 copies/ml) are randomly assigned to receive CCRT alone or induction chemotherapy plus CCRT. Patients in both groups receive cisplatin 100 mg/m² every 3 weeks for 3 cycles, concurrently with intensity-modulated radiotherapy (IMRT). IMRT is given as 2.12 Gy per fraction with five daily fractions per week to a total dose of 70 Gy. The induction chemotherapy plus CCRT group receive gemcitabine (1000 mg/m² d1,8) and cisplatin (80mg/m² d1) every 3 weeks for three cycles before CCRT. Our primary endpoint is progress-free survival. Secondary end points include overall survival (OS), Locoregional progression, Distant progression and toxic effects. All efficacy analyses are conducted in the intention-to-treat population, and the safety population include only patients who receive their randomly assigned treatment.

Eligibility Criteria:
Inclusion Criteria:

1. Age 18-70 years old.
2. Patients with newly histologically confirmed non-keratinizing (according to WHO histologically type).
3. Tumor staged as III-IVa except T4N2/AnyTN3 (according to the 8th AJCC edition) and pretreatment plasm EB Virus DNA\<4000copies/ml.
4. ECOG Performance status less or equal to 1.
5. Male and no pregnant female.
6. Adequate marrow: leucocyte count ≥ 4000/μL, hemoglobin ≥ 90g/L and platelet count ≥ 100000/μL.
7. Normal liver function test: Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) \< 1.5×upper limit of normal (ULN) concomitant with alkaline phosphatase (ALP) \< 2.5×ULN, and bilirubin \< ULN.
8. Adequate renal function: creatinine clearance ≥ 60 ml/min.
9. Patients must be informed of the investigational nature of this study and give written informed consent.

Exclusion Criteria:

1. Patients have evidence of relapse or distant metastasis.
2. WHO Type keratinizing squamous cell carcinoma or basaloid squamous cell carcinoma.
3. Treatment with palliative intent.
4. History of previous RT (except for non-melanomatous skin cancers outside intended RT treatment volume).
5. Prior chemotherapy or surgery (except diagnostic) to primary tumor or nodes.
6. Pregnancy or lactation (consider pregnancy test in women of child-bearing age and emphasize effective contraception during the treatment period).
7. Prior malignancy except adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer.
8. Any severe intercurrent disease, which may bring unacceptable risk or affect the compliance of the trial, for example, unstable cardiac disease requiring treatment, renal disease, chronic hepatitis, diabetes with poor control (fasting plasma glucose \> 1.5×ULN), and emotional disturbance.
Total Splenectomy vs Partial Splenectomy in Non-malignant Hemoglobinopathies : Study Comparing the Effectiveness

Partial splenectomy or total splenectomy are the two surgical treatment of non-malignant hemoglobinoptahie. The aim of this treatment is to decrease transfusion. The main risk is infectious in total splenectomy, that's why partial splenectomy was suggest. But the efficiency of partial splenectomy decrease over time and a totalisation could be mandatory.


Eligibility Criteria:
Inclusion criteria:

* Children between 0- 18 years olds
* Total or partial splenectomy
* Non malignant hémoglobinopathies

Exclusion criteria:

- Total or partial splenectomy outside of non malignant hemoglobinopathies
Letrozole Plus Low-Dose Metronomic Capecitabine Versus EC-T (Epirubicin/Cyclophosphamide Followed by Docetaxel) as Neoadjuvant Therapy for ER+/HER2-negative Breast Cancer

Patients with ER+/HER2- breast cancer (presumably the luminal A subtype) could potentially avoid the standard chemotherapy use. Letrozole Plus Low-Dose Metronomic Capecitabine may offer similar efficacy and less toxicity to standard chemotherapy in ER+/HER2- breast cancer patients.


Eligibility Criteria:
Inclusion Criteria:

-women (age 18-70 years) with clinical T2-3 N0-1 M0 ER-positive (ER) allred score 4-8，and progesterone receptor-positive (PgR) ，HER2-negative adequate bone marrow reserve (WBC count, 3.5 \*109/L; platelets, 100\*109/L; hemoglobin, 10g/dL), hepatic function (AST/ALT bilirubin and alkaline phosphatase levels 1.25 the upper limit of normal value), and renal function (serum creatinine 1.25 the upper limit of normal value).

Luminal A/ lymph node positive breast cancer or Luminal B breast cancer patients

Exclusion Criteria:

* (a) male patients; (b) patients with inflammatory breast cancer or distant metastasis; (c) patients who were previously treated with chemotherapy, radiation therapy or prior treatment with AIs or antiestrogens for breast cancer; (d) patients with a second concomitant neoplasm; and (e) patients who could not meet the eligibility criteria.
Abdominal MR Imaging at 3.0T: Sequence Optimization and Implementation

This project will facilitate the optimization of body MR imaging at 3 Tesla.

This project is meant to improve the image quality of multiple sequences at 3.0T applied to the abdominal and pelvic regions.

Eligibility Criteria:
Inclusion Criteria:

* Subjects between ages of 19 and 65
* Healthy volunteer subjects should not have any history of disease or symptoms - based on clinical history
* Subjects with an underlying disorder (diffuse and focal abnormalities of the liver and pancreas)

Exclusion Criteria:

* Inability to provide informed consent
* A medical or contraindications that will prevent subjects from having a MRI
* Subjects with severe renal dysfunction or patients on dialysis
Enduring Exercise Habits

The objective of this study is to test whether the interventions offering short-term incentives (points redeemable for prizes), specific cued plans, and science-backed tips can help with creating enduring exercise habits. There are four (4) sub-studies within this protocol.

The four sub-studies are:

1. Sweet spot

   Past studies have shown that steady routines associated with stable cues are a hallmark of successful habits. However, recent research has demonstrated that incentivizing an overly rigid routine (e.g., every workout must be at the same time each day) creates a less lasting exercise habit than incentivizing a flexible exercise routine (e.g., workouts can be at any time of day). In this study, the investigators examine whether offering higher rewards for exercise that occurs at a planned, routine time than for exercise at other times, but still offering some rewards for exercise outside of these planned moments, may improve over total flexibility for producing lasting habits.
2. Falling off the Wagon (FOTW)

   In the long run, missing one workout won't make much difference to a person's overall health. Psychologically, however, missing a workout may lead people to feel they've already failed at meeting their fitness goals, zapping their motivation to exercise in the future. In this study, the investigators examine whether offering 50% larger incentive for exercise to people after they miss a planned workout leads to more sustained exercise habits than incentivizing all workouts equally.
3. Think Twice

   Studies have shown that people tend to fall into the planning fallacy -- optimistically overestimating their performance in some future activity. In this study, the investigators examine whether people who the investigators taught about the planning fallacy would make more realistic exercise plans and adhere to those plans better.
4. Weekly vs. Daily Routines (WDR)

This study will examine whether incentivizing people to create a daily routine that is consistent every day for a month or a weekly routine that is consistent every week for a month helps people build a more lasting exercise habit. In the daily routines condition, participants will be required to schedule workouts (and associated text reminders) at the same time of day on every weekday, and the same time of day on each weekend throughout our four week treatment period. In the weekly routines condition, participants will be allowed to schedule workouts (and associated text reminders) at different times on different days of the week, but their schedule must be the same for each of the four weeks of our four week treatment period.

Eligibility Criteria:
Inclusion Criteria:

* Has 24 Hour Fitness Membership

Exclusion Criteria:

-
Bovine Lactoferrin and Antibiotic-associated Diarrhoea.

This prospective, randomized, parallel-group, double blind, single-center study is to be conducted in the Medical University of Warsaw Public Paediatric Teaching Hospital in following departments: Department of Paediatric Gastroenterology and Nutrition, Department of Paediatrics and Nephrology, Department of Pediatric Pneumonology and Allergy, Department of Pediatrics with Medical Assessment Unit, Admissions Department. It is planned to include a total of 156 children aged between 12 months to 18 years old receiving antibiotic therapy because of acute respiratory tract infection/or urinary tract infection. The children will be randomly assigned to receive 100 mg of bovine lactoferrin or placebo twice a day orally for the whole period of antibiotic therapy. The primary efficacy parameter is occurrence of diarrhea during the antibiotic therapy and two weeks after, defined as \> 3 stools a day, a watery or loose stool with/or occurrence of blood in the stool.


Eligibility Criteria:
Inclusion Criteria:

* acute respiratory or urinary infection requiring empiric antibiotic therapy.
* antibiotic treatment started before 24 hours prior to enrollment.
* the consent of parents or legal guardians to participate in the study

Exclusion Criteria:

* severe or generalized bacterial infection
* antibiotic therapy during the last 8 weeks
* use of probiotic during the seven days prior to enrollment
* immune disorders,
* chronic disease of the gastrointestinal tract,
* actual acute or chronic diarrhea,
* intake of iron supplementation,
* cows milk protein allergy
* lack of consent of the parents or legal guardians to participate in the study.
An Open Label Study of the Safety and Efficacy of Psilocybin in Participants With Treatment-Resistant Depression (P-TRD)

The primary objective of this study is to evaluate the efficacy of psilocybin (25 mg) administered under supportive conditions to adult participants with severe TRD, in improving depressive symptoms.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of at least moderate Major Depressive Disorder (MDD)

Exclusion Criteria:

* Comorbidities

Note for CA site: Only Veterans are Eligible
Study of Sleep Disorders in Prodromal and Definite Parkinsons Disease

Multicenter controlled study of sleep disorders in isolated REM Behavior Disorder and Parkinson\&#39;s disease (SOMPARK)

Sleep disturbances are common and understudied in established or prodromal Parkinson\&#39;s disease. The purpose of this study is to systematically and comprehensively determine the clinical characteristics and electrophysiologic patterns of the major sleep disorders in PD and isolated RBD.

Eligibility Criteria:
Inclusion Criteria:

Common to all groups:

* Age superior 18 years
* Patients who have received complete information about the study from an investigator and who fully consent to participate.

For Parkinson Disease (PD):

* Patients followed for PD diagnosed according to international criteria for the diagnosis of PD (MDS criteria),
* A MoCA score greater than 20/30
* No treatment with deep brain stimulation.

For REM Sleep Behavior Disorder (RBD):

* Diagnosis of RBD according to ICSD-3 criteria: presence on polysomnography of an abnormal elevation of muscle tone during REM sleep (more than 18% of REM sleep without chin atonia) and/or the presence of REM sleep behaviors on video-polysomnography,
* Absence of progressive neurodegenerative pathology: absence of diagnostic criteria for PD, multiple system atrophy, or Lewy body dementia.

For healthy controls:

- No neurological or psychiatric disease

Exclusion Criteria:

Common to all groups:

* Pregnant or breastfeeding women
* Subjects under guardianship/conservatorship
* Persons deprived of liberty.