cyrilzakka/clinical-trials huggingface dataset:
Effect of Puerarin on Heart Health in Men

This study aims to assess the effect of puerarin supplementation on cardiovascular disease risk factors in men.

Objectives: To assess the effect of puerarin supplementation on cardiovascular disease risk factors in men.

Study design: A randomized, double-blind, placebo-controlled, 2-way crossover trial of 12-week puerarin supplementation.

Study subjects: 234 Hong Kong Chinese men aged 18-50 years without a history of cardiovascular disease.

Intervention: After assessing eligibility, all participants will be randomized to take a puerarin supplement in granules (90.2 mg daily) or a placebo, followed by a 4-week wash-out period, after which participants will be crossed over to the other intervention.

Primary outcomes: Lipid profile (total cholesterol, low density lipoprotein (LDL) cholesterol, high density lipoprotein (HDL) cholesterol, triglycerides).

Secondary outcomes: Cardiovascular disease risk factors, such as blood pressure and fasting glucose, as well as some potential mediating pathways, such as testosterone.

Methods: An intention to treat analysis will be used, assuming no changes in baseline value for missing follow up values. Differences in outcomes between supplementation and placebo within participants will be compared using a paired t-test, after checking for the possibility of a carryover effect.

Expected results: The short-term effect of puerarin on cardiovascular disease risk factors in men will be obtained so as to confirm or refute previous trials usually with small sample sizes that suggest puerarin may improve lipid profile and reduce testosterone. The findings will also add evidence about the effects of puerarin on other potentially relevant risk factors, such as blood pressure, fasting glucose and testosterone, as well as some related biomarkers.

Eligibility Criteria:
Inclusion Criteria:

* Men
* Aged 18 to 50 years
* Chinese ethnicity
* Willing to make return visits
* Not currently taking any traditional Chinese medicine (including puerarin) supplementation
* Not currently receiving hormone replacement therapy, such as testosterone replacement therapy, in the past 12 months
* Free of any congenital diseases
* Free of any infectious diseases e.g. seasonal influenza
* With no history of any chronic diseases including coronary heart disease (ischemic heart disease), myocardial infarction (heart attack), stroke, diabetes and cancer
* Have a 10-year risk of ischemic heart disease of less than 10%

Exclusion Criteria:

* Women
* Men, who did not meet the aforementioned inclusion criteria, and/or unable or unwilling to provide consent
A Phase 3 Study of SYM-1219 Treatment of Women and Post-Menarchal Adolescent Girls With Bacterial Vaginosis

The purpose of this clinical trial is to test the safety and efficacy of the oral investigational new drug, SYM-1219 for the treatment of bacterial vaginosis.


Eligibility Criteria:
Inclusion Criteria:

* Are premenopausal adult females or post menarchal adolescent girls ≥12 years of age in good general health
* Have a clinical diagnosis of bacterial vaginosis, defined as having all of the following criteria:
* Off-white (milky or gray), thin, homogeneous vaginal discharge
* Vaginal pH ≥ 4.7
* Presence of Clue cells of ≥ 20% of the total epithelial cells on microscopic examination of the vaginal saline wet mount
* A positive 10% KOH Whiff test
* Have a Gram stain slide Nugent Score ≥ 4 at the Baseline Visit (Day 1)

Exclusion Criteria:

* Are pregnant, lactating, or planning to become pregnant during the study
* Are menstruating or have vaginal bleeding at the Baseline Visit (Day 1)
* Are suspected clinically (or confirmed diagnostically) of having alternative causes of vaginal symptoms including candidiasis, Chlamydia trachomatis, Trichomonas vaginalis, Neisseria gonorrhoeae or Herpes simplex
* Have received antifungal or antimicrobial therapy (systemic or intravaginal) within 14 days prior to the Baseline Visit (Day 1)
Omega-3 Fatty Acids in Chronic Periodontitis.

Omega 3 fatty acids is one such dietary supplement, known to modulate the host response in chronic conditions like cardiovascular diseases, rheumatoid arthritis, ischemic cerebrovascular diseases, osteoporosis by producing Resolvins and protectins without showing any inadvertent effects.Addition of systemic Omega 3 Fatty Acids with SRP may enhance the therapeutic result of Chronic Periodontitis owing to host modulation \& anti-inflammatory properties. If proven, this can be used as a routine treatment modality.


Eligibility Criteria:
Inclusion Criteria:

1. Patients within age group of 30 to 55 years.
2. Systemically healthy individuals.
3. Patients with chronic generalized periodontitis (moderate and severe)according to Center for Disease Control (CDC) working group, 2007 criteria.

Exclusion Criteria:

1. Patients with systemic illnesses (i.e., diabetes mellitus, cancer, human immunodeficiency syndrome, bone metabolic diseases, or disorders that compromise wound healing, radiation, or immunosuppressive therapy),
2. Smoking,
3. Chronic alcoholics,
4. Pregnancy or lactation,
5. Use of Non Steroidal Anti Inflammatory Drugs, steroids or antibiotics / antimicrobials within September 2012 to August 2013,
6. Confirmed or suspected intolerance to omega 3 fatty acids,
7. Periodontal therapy done within the September 2012 to August 2013.
Clinical Study of ATTR-CM

In this study, patients with ATTR-CM or gene carriers were selected to study the diagnosis and treatment, and long-term follow-up was conducted.


Eligibility Criteria:
Inclusion Criteria:

* Patients and gene carriers of ATTR-CM confirmed in the Second Affiliated Hospital of Zhejiang University School of Medicine, regardless of gender, age 18-90 years old;
* Patients who have the ability to understand the test and can cooperate with investigators

Exclusion Criteria:

* Patients who unable to understand or unwilling to fill in informed consent forms or follow visitors
a Randomized Controlled Trial Comparing Medical and Medical-surgical Treatment in Diabetic Foot Osteomyelitis

Osteomyelitis is a frequent complication of diabetic foot ulcer. Several therapeutic strategies are used : medical treatment with antibiotics and foot offloading or surgical treatment consisting in the resection of infected bone and a shorter antibiotic course. The medical treatment risk is a longer healing time and a risk of bone infection relapse. The surgical treatment risk is the ulcer relapse because of the modification of the foot structure. These treatments need to be compared in terms of benefit/risk ratio. Our hypothesis is : 1) in the medical treatment group a 7 month mean healing time of and a 15% osteomyelitis recurrence rate;2) in the medical-surgical treatment group a 4 month mean healing time and a 10% osteomyelitis recurrence rate.

The study aim is to compare the rate of therapeutic success of the secondary ostéite with a wound of the foot diabetic, obtained either by a single medical coverage(care), or by a medical surgical coverage(care). The therapeutic success being defined by the association of 1) the absence of local distribution(broadcasting) of the ostéite 2) the healing of the wound 3) in 12 months of the healing the absence of local recurrence of the ostéite

Eligibility Criteria:
Inclusion Criteria:

* diabetes
* neuropathy and a forefoot ulcer
* osteomyelitis on X ray involving one or two contiguous ray
* confirmed osteomyelitis on bone biopsy if a metatarsal head is involved
* palpable distal pulses

Exclusion Criteria:

* glomerular filtration rate \< 30ml/min
* whole bone destruction
* contra-indication for off loading
* ASAT or ALAT \> three times normal rate
* immunosuppressive drugs
* Charcot foot on the concerned foot
* pregnancy
Personal Therapy Comfort Settings Pilot Clinical Study

350 participants will be enrolled in this study. The target population are patients newly diagnosed with OSA and starting CPAP treatment.

User accessible customizable comfort settings (Response setting, expiratory pressure relief (EPR) on/off and EPR level, and Ramp) will be set to either default (control group), or personalized for that participant (active treatment group).

Usage will be recorded for the first 1 month of CPAP treatment, to determine if customizing comfort settings can improve CPAP compliance


Eligibility Criteria:
Inclusion Criteria:

* Patients willing to give written informed consent
* Patients who can read and comprehend English
* Patients who are ≥ 18 years of age
* Patients newly diagnosed with OSA and indicated for CPAP therapy.

Exclusion Criteria:

* Patients who have previously used PAP therapy
* Patients who require a bilevel device
* Patients who are or may be pregnant

  \* Patients who are unable to attend follow up appointments
* Patients with a preexisting lung disease/ condition that would predispose them to pneumothorax (for example: COPD, lung cancer; fibrosis of the lungs; recent (\< 2years) case of pneumonia or lung infection; lung injury
* Patients believed to be unsuitable for inclusion by the researcher
Clinical Efficacy of Qingxin Zishen Decoction in Treating Menopausal Syndrome and Neuroendocrine Mechanism of Regulating KNDy Neurons

The goal of this clinical trial is to determine the effects of estrogen (Fenmotong) and Qingxin Zishen Decoction on the levels of kisspeptin, NKB, and dynorphin expressed in human KNDy neurons Between patients with menopausal syndrome. The aims of the study are as follows:

* Find a new neuroendocrine mechanism of Qingxin Zishen Decoction in the treatment of menopausal syndrome.
* Evaluate the changes of new neuroendocrine indicators in the clinical treatment of menopausal syndrome.
* Develop non-hormonal drugs with definite efficacy in the treatment of menopausal syndrome.

Participants will randomly divided into the experimental group and the control group, the experimental group will be oral fenmotong, and the control group will be oral Qingxin Zi Kidney Decoction, and the efficacy, sex hormone levels and neuroendocrine index changes of the two groups will be compared.


Eligibility Criteria:
Inclusion Criteria:

* Women aged 41\~55;
* KIM score≥ 15 points;
* The number of hot flashes and sweating≥ 3 times/day;
* Menopause time≥ 6 months;
* FSH\>30mIU/ml,E2\<30ng/L;
* Informed consent, voluntary testing.

Exclusion Criteria:

* Unexplained vaginal bleeding;
* Sex hormone-related malignant tumors cannot be excluded;
* premature ovarian failure, or endometriosis, or hysterectomy, or bilateral adnexectomy;
* Combined with primary liver and kidney dysfunction, cardiovascular and cerebrovascular diseases, blood system diseases and other serious diseases that affect their survival;
* Exposure to sex hormone-related drugs within 3 months;
* Patients with mental abnormalities, or those with a history of alcohol or drug abuse;
* Those who have allergic reactions to the study drug;
* Those who are participating in other drug clinical researchers.
A Study to Evaluate the Efficacy and Safety of Risperidone (R064766) in Children and Adolescents With Irritability Associated With Autistic Disorder

The purpose of this study is to evaluate the efficacy of risperidone compared with placebo in children and adolescents with irritability associated with autistic disorder.

This is a randomized (the drug is assigned by chance), 8-week, double-blind (neither physician nor patient knows the treatment that the patient receives), placebo-controlled (placebo is an inactive substance that is compared with a drug to test whether the drug has a real effect in a clinical trial), parallel-group (each group of patients will be treated at the same time), flexible-dose, multicenter study. It will be followed by a 48-week, flexible-dose, open-label (all people know the identity of the intervention) extension, to evaluate the efficacy and safety of risperidone in children and adolescents with a diagnosis of autistic disorder (severe form of pervasive developmental disorder) who have associated irritability. The study consists of up to 2-week screening phase, an 8-week double-blind phase, a 48-week open-label phase, and a 1-week follow-up phase.

Eligibility Criteria:
Inclusion Criteria:

* Diagnostic for autistic disorder
* A Clinical Global Impression - Severity (CGI-S) score of =\>4 and an Aberrant Behavior Checklist - Japanese Version (ABC-J) Irritability Subscale score of =\>18
* Patients with mental age of \>18 months as measured by appropriate developmental or mental scales
* Patients who have an appropriate caregiver, eg, parent or study-site personnel, who is able to observe the patient's condition, provide information, and evaluate the patient's response appropriately

Exclusion Criteria:

* Patients with previous or current psychotic disorder (eg, schizophrenia, bipolar disorder, or other psychiatric disorders) or with pervasive developmental disorder not otherwise specified, Asperger's disorder, Rett's disorder, pediatric destructive behavior disorder, or substance dependence
* Patients with a clinically significant endocrine, metabolic, cardiac, hepatic, renal, or pulmonary disorder, or hypertension
* Weight of \<15 kg at the time of screening and baseline
* Patients with QTc\>450 msec in the standard 12-lead electrocardiogram (ECG) at the time of screening
* Patients with known hypersensitivity to risperidone or paliperidone
Understanding Immunity to the Flu Vaccine in COVID-19 Patients

The purpose of this study is to measure immunity to the flu vaccine over time in patients who have had COVID-19 and may have other medical conditions including obesity, type 2 diabetes, chronic fatigue, or long-term COVID-19 symptoms. Adults and children (age 13 to 64) who had been diagnosed with COVID-19 as well as controls without COVID-19 will be invited to participate in this study.


Eligibility Criteria:
Inclusion Criteria:

* Age 13 through 64 years
* Diagnosed with COVID-19 at least 2 months prior enrollment
* Patients with or without obesity, diabetes, chronic fatigue and/or long term COVID-19 symptoms
* Patients without COVID-19 diagnosis for controls

Exclusion Criteria:

* Received the influenza vaccine less than 4 months ago
* Pregnant or lactating
* Patients with special risks attendant to venipuncture
* Use of immunomodulatory medications
* Immunodeficiency or autoimmune disease
Iron Overload and Growth Velocity in Thalassemia and Sickle Cell Anemia

Iron overload impaired growth in Thalassemia patients due to iron deposition in the endocrine glands, including the hypophysis and gonads. The issue of iron overload in Sickle Cell Anemia is recently studied more extensively and preliminary studies shows that endocrine damage is rarer in those patients.

Growth velocity was not systematically studied in patients with Iron Overload, even in thalassemia patients in spite several studies that assess the endocrine function in those patients. In Sickle Cell Patients this issue was not studied.

The purpose of this study is to assess the growth velocity in a cohort of Thalassemia Major and Intermedia patients and compare the results to another group of Sickle Cell patients, including Sickle cell thalassemia.

Growth velocity, endocrine function and iron overload status will be studied in the patients that are in follow up at the Pediatric Hematology Unit, at the Ha'Emek Medical Center.

Patients who were lost from follow up or insufficient data about growth in the past will not included in the study.

Eligibility Criteria:
Inclusion Criteria:

* All patients in follow up with available medical charts.

Exclusion Criteria:

* Patients lost from follow up or without enough data to calculate growth velocity or clinical and laboratory endocrine assessment or missing data about iron status.
Safety and Efficacy of Benefix in Patients With Hemophilia B in Usual Care Settings in China

The purpose of this post-approval study is to evaluate the safety and efficacy of Benefix in subjects with hemophilia B in usual care settings in China.

The purpose of this post-approval study is to provide supplementary information relating to the use of BeneFIX in Chinese subjects with hemophilia B, especially on the safety and efficacy in different populations of Chinese hemophilia B patients, in particular in pediatric patients \<6 years of age, pediatric patients ≥6 to ≤12 years of age, Previously Untreated Patients (PUPs) , subjects receiving prophylaxis treatment after enrollment in the study, and severe patients (FIX activity \<1%).

Eligibility Criteria:
Inclusion Criteria:

* Male and/or female subjects with hemophilia B.
* Subjects/parents/legal representatives must be able to comply with study procedures (informed consent/assent process, clinical visits, reporting of infusion and bleed data, reporting of adverse events, etc)

Exclusion Criteria:

* Presence of any other bleeding disorder in addition to hemophilia B. Subjects with a past history of, or current factor IX inhibitor. For laboratory-based assessments, any Bethesda inhibitor titer greater than the laboratory's normal range or ≥0.6 Bethesda Unit (BU)/mL.
* Subjects with known hypersensitivity to the active substance or to any of the excipients of BeneFIX.
* Subjects with a known hypersensitivity to Chinese Hamster Ovary cell proteins.
Fluid and Salt Restriction in Decompensated Heart Failure Patients

The non-pharmacological measures that are widely practiced and recommended for HF patients, such as salt and water restriction, specially at moments of disease decompensation, still lack clearer evidence of their therapeutic effect.

Heart Failure Clinics, healthcare structures formed by a multidisciplinary team specialized in the disease, have demonstrated to provide benefits to patients through multiple non-pharmacological interventions, among them fluid and salt restriction. Sodium restriction has a class I recommendation and evidence level C, that is, general agreement that the intervention is beneficial, useful and effective, evidenced by consensus, expert opinion, small studies, retrospective studies or registries. Sodium restriction becomes even more controversial when we consider evidence suggesting the benefit of non-salt restriction or treatments with salt administration, in the form of hypertonic solutions. In face of literature evidence not showing conclusive results about the benefit of sodium and fluid restriction, we designed this study in order to assess the effect of fluid and salt restriction on the management of patients hospitalized due to decompensated heart failure

Eligibility Criteria:
Inclusion Criteria:

* Patients of both sexes, with age equal to or above 18 years, diagnosed with decompensated HR (systolic dysfunction), according to the Boston Criteria (score \> 8 points), who agree to participate in the study and sign an informed consent form.

Exclusion Criteria:

* Patients presenting with endogenous creatinine clearance (ECC) values lower than or equal to 50-60 mL/min (obtained by the Cockcroft-Gault equation) at hospital admission, cardiogenic shock, survival compromised by another evolving disease, those with difficulty complying with treatment (dementia, cognitive deficit).
Efficacy of Cricoid Pressure in Occluding the Esophageal Entrance: A Glidescope ® Study

This investigation was designed to assess the patency of the esophageal entrance during cricoid pressure (CP) in anesthetized, paralyzed obese and non obese patients using the Glidescope ® video laryngoscope (GVL).

Eighty-nine patients undergoing surgeries necessitating general anesthesia and tracheal intubation were enrolled in this study. Group 1 (OB) including obese patients (n= 59) was undergoing bariatric surgery. Following rapid sequence induction/intubation (RSII) anesthesia with cricoid pressure, clear view of the vocals cord and the entrance to the esophagus were assessed using Glidescope® video laryngoscope before intubation and following intubation. Following securing the airway, efficacy of cricoid pressure was tested by the capability to insert gastric tubes (20 and 38 Fr) under direct vision using GVL. Group 2 (NOB) including non-obese patients (n=30) was undergoing moderate surgery requiring tracheal intubation under general anesthesia. Efficacy of cricoid pressure was also tested similarly using GT's (20 and 38 Fr) following induction of anesthesia and before intubation. Inability of GT insertion was recorded as non-patent esophagus (effective CP) and successful insertion of GT was recorded as patent esophagus (ineffective CP). Then CP was released and insertion of GT achieved for correct verification of the esophageal opening position in both groups.

Eligibility Criteria:
Inclusion Criteria:

* Obese patients ( BMI 40-70 kg/m2)
* No Contre indication to cricoid pressure
* No-obese patients (BMI \< 40)

Exclusion Criteria:

* ASA 3 and 4
* Contre indication to cricoid pressure
The Effect of Human Amniotic Membrane Allograft on Functional Recovery After Flexor Tendon Repair

The objective of this pilot study is to gain observational insight into potential preventive features of amniotic membrane transplantation in the adhesion formation after flexor tendon repair.

The treatment of flexor tendon transection consists of surgical apposition of the lacerated tendon ends using non-absorbable sutures. Main complications which result in poor outcome of the tendon repair are the rupture of the tendon apposition or substantial adhesion formation between the two tendons or the tendon and the fibro-osseous canal. Adhesion formation is presumed to be a byproduct of the tendon healing. In the course of last 70 decades, the preventive effects of several pharmacological agents and mechanical barriers on adhesion formation have been investigated with some promising findings. One of the mechanical barriers that has been proposed to be suitable for adhesion prevention is human amniotic membrane allograft. However, there are no clinical studies evaluating the use of amniotic membrane in flexor tendon repair.

This is a pilot study for the forthcoming randomized controlled study. The objectives of the pilot study are: 1) to test the handleability of the human amniotic membrane allograft in flexor tendon sheath reconstruction in conjunction with flexor tendon repair, 2) to elucidate the possible adverse effects related to the use of amniotic membrane in flexor the sheath, and 3) to gain observational insight into potential preventive features of amniotic membrane transplantation in the adhesion formation. The hypothesis of the pilot study is that the application of the human amniotic membrane allograft in tendon sheath reconstruction in flexor tendon injury patients is technically feasible and results in no adverse effects to the patient.

A total of 10 patients with an acute flexor tendon injury will be included in the pilot study. After conventional tendoraphia, the amniotic membrane will be wrapped around the tendons and its borders will be fixed to the remaining tendon sheath. The primary outcome measure is total range of movement after 6 months of the surgery.

Eligibility Criteria:
Inclusion Criteria:

* Acute flexor tendon transection in zone 2 in digits 2, 3, 4, or 5 (diagnosed within 1 week after the injury)
* Age over 18
* Patient's willingness to participate in the study

Exclusion Criteria:

* Tendon transection within 8 mm of its distal insertion (requiring reinsertion)
* Soft-tissue loss, severe crush, fracture, palmar plate injury, patient requiring revascularization
* Cognitive impairment or other factors (prisoner, military serviceman) which may affect one's decision making
* Substance abuse
* Pregnancy