cyrilzakka/clinical-trials huggingface dataset:
The Treatment Effect of Chinese Herbal Compound Ointment on Atrophic Vaginitis

Objective：To evaluate the effect and safety of the traditional chinese medicine oil agent on senile atrophic compared as compared to estriol cream in aged woman.

Design: A randomized double-blind controlled trial.

Setting: The hospital ward.

Participants: 200 postmenopausal woman with senile vaginitis (mean age 56).

Intervention: The traditional chinese medicine oil and estriol cream were separately intravaginal administrated in treatment group and control group for 3 weeks，follow-up 1 month.

Measurement: symptom improving(pain and itch) and onset time, edema-size of vaginal wall, vaginal discharge, and PH changes.

80 postmenopausal women living in the communities near the hospital with AV (atrophic vaginitis) symptoms were recruited for this clinical trial. Patients with AV receiving external treatment and requiring hospitalization were randomized in a double-blind, single-centre trial. Subjects received CHCO (Chinese Herbal Compound Ointment) topical vaginal application in experimental group, while estriol in control group. The dosage of medicine for single treatment once a day in two group is 0.5g.The total time for therapy is 3 weeks in two groups. Assessment indicators：vagine PH, sIgA and IL-1βchanges, the degree of symptoms improving, onset time, edema-size of vaginal wall, vaginal discharge, and relapses and retreatment effect.

Eligibility Criteria:
Inclusion Criteria:

* Postmenopausal women
* With typical clinical manifestations: virginal genital itching or burning sense, Increased vaginal secretions, a yellow, a serious bloody pus-like leucorrhea, or sexual intercourse pain
* Gynecological examination: Vaginal epithelium atrophy，Vaginal folds flat or disappear， mucosal hyperemia， superficial ulceration
* Both ALT and AST are normal or less than 2 times, bilirubin is normal
* Serum creatinine level is within the normal range
* ECG is normal;

Exclusion Criteria:

* Gynecological and breast Oncology, endometrial hyperplasia(≥5mm)
* Estrogenic drugs or probiotics used in four week
* Participate in other clinical trials;Thrombotic diseases
* Abnormal vaginal bleeding without clear diagnose
* Estriol allergy
* Severe pneumonia, tuberculosis, lung abscess, myocarditis
* heart,liver or kidney failure(NYHA class III-IV,ALT to AST ratio twice more than upper limit of normal
* sexually transmitted diseases;mental disorders
Heart Failure With Mildly Reduced Ejection Fraction Registry

Heart failure (HF) affects about 1% of patients younger than 55 years, whereas the prevalence of HF increases \> 10% in patients with at least 70 years of age. Despite HF with reduced ejection fraction (HFrEF) and HF with preserved ejection fraction (HFpEF), the clinical significance of HF with mildly reduced ejection fraction (HFmrEF) has gained more importance within the past years. Those patients are characterized by a left ventricular ejection fraction (LVEF) of 41-49%. However, within the current European guidelines, limited treatment recommendations in this subgroup of HF are yet available as a consequence of the limited number of studies in this field. The "Heart Failure With Mildly Reduced Ejection Fraction Registry" aims to characterize patients with HFmrEF and investigated the prognostic impact of interventional and pharmacological therapies in this subgroup of HF patients.


Eligibility Criteria:
Inclusion Criteria:

* Patients with HFmrEF (i.e., LVEF 41-49%)
* Patients with at least 18 years of age

Exclusion Criteria:

* Patients younger than 18 years of age
Low-moderate Intensity Pedaling During Immunotherapy Administration

The purpose of this study is to determine the feasibility pedaling using an under-the desk bike during immunotherapy infusions. Also, the study hopes to evaluate how pedaling impacts quality of life and treatment response biomarkers. Lastly, the study will evaluate the relationships between treatment response and muscle mass which is evaluated with computerized tomography (CT) scans.


Eligibility Criteria:
Inclusion Criteria:

* Minimum age of 18
* Renal Cell Carcinoma, cutaneous malignancies (Melanoma, Merkel Cell Carcinoma or Squamous Cell CA) or bladder cancer.
* Planned intravenous immunotherapy treatment (Pembrolizumab, Nivolumab, or combinations as clinically indicated by standards of care).
* ECOG Performance Status of Grade 0-2
* No uncontrolled cardiac disease

Exclusion Criteria:

* ECOG Performance Status of Grade 3-5
* Severe cardiac history or comorbidities (i.e. heart failure, clinically significant aortic stenosis, history of cardiac arrest, have a cardiac defibrillator, uncontrolled angina, uncontrolled arrhythmias, major heart surgery, stroke, or pulmonary embolus).
* Chest pain or severe shortness of breath at rest or with physical activity.
* Orthopedic impediments to exercise (i.e. joint immobility or lower extremity lymphedema).
* Limitations to sustained exercise (i.e. bone metastases in the femur neck).
* Severe arthritis (i.e. osteoarthritis or rheumatoid arthritis).
* Patients will be excluded from study if their immunotherapy treatment requires the use of sedating antihistamines prior to treatment.
The Lean Meats Mediterranean Diet Study

The purpose of the proposed research study is to assess the effects of including greater amounts of minimally processed red meat (lean pork and beef) into a Mediterranean Diet on cardiometabolic and emotional well-being.

All subjects will complete an 18-wk randomized crossover study. Following a 2-wk baseline testing period to assess cardiometabolic and emotional well-being and habitual diet, subjects will consume a Mediterranean-style, weight-maintenance diet that is either restricted or rich in lean, minimally processed red meat for 5 weeks. Following a 4-wk washout period and second 2-wk baseline testing, subjects will consume the Mediterranean Diet with the alternate predominant animal protein sources for 5 weeks. Cardiometabolic and emotional well-being will be assessed during baseline and post periods.

Eligibility Criteria:
Inclusion Criteria:

* Male or female 30-69 years old
* BMI 25-37 kg/m2
* Total cholesterol \<240 mg/dL
* Low-density lipoprotein \<160 mg/dL
* Triglycerides \<400 mg/dL
* Fasting glucose \<110 mg/dL
* Systolic blood pressure \<160 mmHg
* Diastolic blood pressure \<100 mmHg
* Body weight \<300 lb
* Weight stable for 3 months prior (±10 lb)
* Stable physical activity regimen 3 months prior ≤3 h/wk of moderate or high intensity exercise resistance or aerobic training
* Medication use stable for 6 months prior.

Exclusion Criteria:

* Diabetic
* Smoker
The Effect of Blood Flow Restriction Training on Glycemic Control Among Type 2 Diabetes Patients

Blood flow restriction training (BFRT) combined with resistance or aerobic exercise has been shown to improve the glucose uptake in humans. In addition, BFRT represents a low-load, alternative exercise program for type 2 diabetes patients who often have reduced physical fitness. However, it is not clear to what extent could BFRT improve glycemic control among patients with type 2 diabetes. This pilot randomized-controlled trial aims to investigate the effect of a 12-week, low-intensity BFRT on glycemic control among patients with type 2 diabetes, compared to medium-high intensity aerobic exercise or low-intensity exercise without BFRT.

Objectives:

The pilot randomized study aims to explore the effects of blood flow restriction combined with aerobic training (BFRT) on the glucose and lipid metabolism indexes and vascular endothelial factors of type 2 diabetes, by comparing it with traditional low-intensity and high-intensity aerobic training. It aims to evaluate the effectiveness of BFRT in glycemic control of type 2 diabetes patients.

Study Population:

A total of 60 patients with type 2 diabetes who are 50-65 years old at the Maigaoqiao Community Health Service Center, Qixia District, Nanjing, China, with a course of type 2 diabetes of 2-10 years will be included as the participants.

Randomization:

Participants will be stratified by baseline hemoglobin A1c (HbA1c) and age, they will be randomly assigned into three groups with a block size of six. The study groups are: 1) low-intensity training combined with blood flow restriction group (LI-BFR group, 40% heart rate reserve combined with 50% arterial occlusion pressure, n=20) 2)high-intensity aerobic exercise group (HI group, 70% heart rate reserve, n=20) 3) Low-intensity group (LI group, 40% heart rate reserve, n=20).

Eligibility Criteria:
Inclusion Criteria:

* type 2 diabetes patients diagnosed by at least one of these criteria: 1) random blood glucose \>= 11.1mmol/L; 2) fasting blood glucose \>= 7.0 mmol/L; 3) 2-hr post oral glucose tolerance test blood glucose \>= 11.1mmol/L; 4) hemoglobin A1c \>= 6.5%.
* aged between 50-65 years at baseline
* disease course of type 2 diabetes between at least 1 year

Exclusion Criteria:

* type 1 diabetes
* fasting blood glucose \> 16.7 mmol/L, or suffers frequent hypoglycemia, or have significant glucose fluctuations considered by the physician
* body mass index \> 33 kg/m2
* severe diabetes complications, including cardiovascular diseases, cerebrovascular diseases, diabetic retinopathy, kidney diseases, diabetic ketoacidosis, and diabetic foot ulcers
* neuromuscular disorders, sarcopenia, severe osteoporosis, dementia
* have regular moderate-intensive exercise habit
* resting systolic blood pressure \>= 160 mmHg or resting diastolic blood pressure \>= 100 mmHg
* abnormal electrocardiogram
* other comorbidities or medications irrelevant to diabetes treatment that may influence glycemia during the past 6 months
Optimized Supervised Education Program for Peripheral Arterial Disease

Peripheral arterial disease (PAD) is a frequent and serious chronic disease witch is undertreated. The recommended management of PAD include pharmacological approach and lifestyle modifications. Patient education help to reach this outcome. Our study propose to compare patient education management with physical activity coaching to usual care.


Eligibility Criteria:
Inclusion Criteria:

* Patients aged 18 to 75 years
* With peripheral arterial disease
* Who accept to follow a patient education program

Exclusion Criteria:

* Permanent limb ischemia
* Revascularisation programmed in the 6 next months
* Other severe prognostic disease
* Difficulties to obtain patient consent because of language or understanding
Spatial Cognitive Training

This study is designed to see if doing regular training on a spatial imagery task leads to improvements in the ability to do the trained spatial imagery task and in the ability to get around in everyday activities.

The investigators will recruit 40 blind participants, randomized by the investigators' CVNR statistician into two groups. One group will undergo the experimental intervention (spatial cognitive training) and the other will undergo a control intervention involving letter-number matching. The participants will include women and minorities in proportion to the demographics of the Veteran population attending the Atlanta VA.

Eligibility Criteria:
Inclusion Criteria:

* Inability to perceive visual stimuli, i.e. no light perception, with stable visual loss over the past year
* The investigators anticipate that causes of blindness will be ocular, including:

  * glaucoma
  * diabetic retinopathy and macular degeneration
  * the most common causes of blindness in Veterans
  * as well as possibly late-onset Leber's optic atrophy and ocular trauma (in the absence of TBI)
* To minimize heterogeneity due to variations in age and the duration of visual loss, the investigators will restrict enrollment to Veterans and Non-Veterans over the age of 50 who lost light perception within the last 5 years, and who have completed standard O\&M training.
* From a practical standpoint, this also enables the investigators to focus on participants who can potentially benefit most from the proposed intervention.

Exclusion Criteria:

* Participants will be excluded if they have any neurological condition, such as:

  * TBI
  * history of blast exposure
  * stroke
  * brain tumors
  * epilepsy, etc.
* Participants will also be excluded if MRI scanning is contra-indicated, e.g.:

  * due to an implanted device such as a pacemaker
  * or foreign bodies of ferromagnetic nature
* Cognitive screening will be performed using the Repeatable Battery for Assessment of Neuropsychological Status (RBANS, Randolph, 1998) and participants with cognitive impairment will be excluded based on a score of 1.5 SD below the mean for the Verbal Memory Index.
* The investigators will test participants' hearing using a validated screening questionnaire (Screening Version of the Hearing Handicap Inventory for the Elderly, HHIE-S, Wentry \& Weinstein, 1983, Lichtenstein et al., 1988) followed by assessment of audiometric pure tone (0.5, 1.0, 2.0, 4.0 KHz) hearing thresholds in the CVNR sound booth.
* Participants with more than mild hearing loss (HHIE score \>8 or audiometric thresholds \>40dB) will be excluded (Wentry \& Weinstein, 1983; Wilson, 2009), given that the investigators are relying on audio cues.
* The investigators will also exclude visually impaired Veterans who are dependent on a wheelchair or scooter for mobility, as they will not be able to take part in the real-world task.
Re-Engineered Discharge for Diabetes-Computer Adaptive Testing (REDD-CAT)

Over 27 million Americans are diagnosed with Type 2 Diabetes Mellitus (T2DM), and their health outcomes, including hospitalization, emergency department use, and hospital readmission, are largely driven by social determinants; diabetes complications are largely attributable to unmet health-related social needs. Investigators will conduct a pilot feasibility trial of the Re-Engineered Discharge for Diabetes-Computer Adaptive Testing (REDD-CAT) system to inform the design of a future, fully-powered randomized controlled trial. REDD-CAT will allow clinical staff to preemptively link patients with community-based social services tailored to meet their unique needs in order to reduce avoidable hospitalization and emergency department visits.

Investigators will conduct a pilot study with 30 patients to evaluate the feasibility and limited efficacy of the REDD-CAT social service screening and referral intervention to inform the design of a fully-powered trial. The study will determine the feasibility of delivering the REDD-CAT intervention in a clinical, point-of-care context to inform the design and implementation strategy for a fully powered clinical trial. It is not the purpose of this pilot clinical trial to determine sample size for a larger, fully-powered trial, as investigators already have data from prior readmissions research supporting sample size and power estimates using readmission rates as a primary outcome measure. After obtaining informed consent from a participant and gathering baseline data, the study research assistant (RA) will send a flag in the electronic medical record (EMR) to notify the nurse care manager that a patient has enrolled in the REDD-CAT pilot. The nurse care manager will then incorporate the administration of the REDD-CAT to the patient as part of standard care discharge planning. He or she will utilize the REDD-CAT results report as a guideline for generating appropriate referrals to address unmet social needs identified. To inform secondary measure selection for a future larger study, the RA will administer to enrolled patients a number of standardized measures, including the PHQ-9, GAD-7, Ways of Coping Questionnaire, and Diabetes Distress Scale. All baseline measures will be re-administered at 30-day follow-up to patients via the telephone. Data on hospitalizations and ED visits during the 30-day period post-discharge will be obtained from patients' medical records, and all data gathered will be stored in a REDCap electronic database.

Eligibility Criteria:
Inclusion Criteria:

* Boston Medical Center inpatient
* Lives in the greater Boston area
* Diagnosis of Type 2 diabetes
* English- speaking
* Demonstrated willingness and capacity to consent
* Age 18 or older
* Has reliable telephone access

Exclusion Criteria:

* Currently pregnant
* Has plans to leave the area for \>2 weeks in the 45 days following enrollment in the study
* Diagnosis of dementia, memory loss, or memory deficit
Qualification of Point-of-Care Assays for Management of HCV Patients

Acute or chronic HCV infection can lead to liver complications, including liver failure, cirrhosis or liver cancer. For patients with hepatitis C infection, the major clinical question remains the terms of treatment initiation. In Europe, new treatments are available since the approval of three direct acting antivirals. However with the high cost of these treatments, they are currently only available for critically ill patients. Other molecules are currently in advanced clinical development phases. The use of clinical predictors remains relevant for the selection of a suitable treatment for each patient, in particular to limit the adverse effects and reduce costs. Currently the quantification of viral load is a measure of response to treatment; with the recommendation to stop treatment in patients who fail to achieve an undetectable level of viral load. Genetic factors have also been identified as predictors of response to treatment, in particular polymorphisms of the IL-28B gene. Genotyping of this gene is currently performed using classical PCR amplification applied to DNA extracted from blood, with a time to result of 2-3 weeks. We propose in this protocol to test a non-invasive method and rapid test for IL-28B genotype which could be used for point of caring testing, and ultimately better patient management.

This is a monocenter, cross-sectional study among HCV chronic patients. The study will be conducted in 250 HCV patients, all viral genotypes combined, at Cochin Hospital (Paris, France).

Objectives The principal objective is to assess the accuracy of the newly developed Point-of-Care genotyping assay (Genedrive® IL-28B Assay) to detect in HCV patients the genotype CC versus non CC (i.e. CT and TT) against the TaqMan Allelic Discrimination Assay as gold standard.

The secondary objective is to assess the concordance between the genotype results of the Genedrive and the gold standard regarding the three genotypes CC, CT and TT.


Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years old.
* Patients diagnosed with hepatitis C (all viral genotypes).
* Patient already treated or recommended to start antiviral therapy against hepatitis C virus or currently undergoing antiviral therapy.
* Patients who consented to IL-28B genotyping in the course of their usual follow-up by conventional PCR standard method.
* Patients affiliated to social security.
* Informed consent must be obtained for all subjects prior to study entry.

Exclusion Criteria:

* A person deprived of liberty by judicial or administrative decision, person subject to a legal protection measure.
Getting to Zero Among Black MSM in the American South

HPTN 096 is a community-randomized, controlled, hybrid-type III implementation effectiveness study. It is designed to evaluate an integrated strategy approach to increase the uptake and use of pre-exposure prophylaxis (PrEP) and viral suppression rates among Black MSM in the southern United States. A status-neutral approach will be taken such that Black MSM, regardless of HIV status (both those living with and without HIV), will be included in the study.


Eligibility Criteria:
The baseline and post-implementation assessment participants will be persons who:

* Self-identify as Black man (inclusive of cisgender and transgender men)
* Self-report a lifetime history of sex with other men
* Are at least 15 years of age
* Self-report current residence in the community of interest
* Are willing and able to provide informed consent
* Agree to complete a short questionnaire
* Agree to provide two blood samples (one by fingerstick and another by venipuncture).

HIV status will not be ascertained prior to participation in these assessments and eligible Black MSM may participate regardless of HIV status.
Hyperbaric Oxygen Therapy Improves Outcome of Hypoxic-Ischemic Encephalopathy

The purpose of this study is to to evaluate the safety and efficacy of hyperbaric oxygen in term gestation newborn infants with hypoxic-ischemic encephalopathy..

Hypoxic-ischemic encephalopathy (HIE) remains a major cause of neonatal death and long term disabilities. Data from animal studies have shown protective effects of hyperbaric oxygen therapy to impaired brain. Recently research priorities have moved from bench to bedside. Several studies have shown a trend for brain protection of hyperbaric oxygen therapy has emerged as a promising treatment for HIE. Therefore,the investigators organized a multi-centered randomized controlled trial of hyperbaric oxygen therapy in HIE newborn infants.

Eligibility Criteria:
* Inclusion Criteria:

  * Newborn infants whose gestational age ≥37 weeks' gestation, weighing over 2500 g ;
  * Acute perinatal event (e.g., late or variable decelerations, cord prolapse, cord rupture, uterine rupture, maternal trauma, hemorrhage, or cardiorespiratory arrest)
  * With an Apgar score ≤ 3 at one minute and ≤5 at five minutes, and/or a potential of hydrogen of 7.0 or less or a base deficit of 16 mmol per liter or more in a sample of umbilical-cord blood or any blood during the first hour after birth.
  * Having moderate-to-severe encephalopathy (indicated by lethargy, stupor, or coma) and either hypotonia, abnormal reflexes (including oculomotor or pupillary abnormalities), an absent or weak suck, or clinical seizures, and/or have abnormal background activity of at least 20 minutes' duration or seizures on amplitude integrated electroencephalography
* Exclusion Criteria:

  * A congenital and the hereditary disease, a chromosome abnormalities, and a congenital abnormality.
  * During the acute phases of intracranial and (or) fundus hemorrhage. o
  * Intracranial infection.
  * Pneumothorax.
  * Infants who have been received hypothermia.