cyrilzakka/clinical-trials huggingface dataset:
Efficacy and Safety of Ginseng Extract on Improvement of Bone Metabolism in Menopausal Women

Recently, osteoporosis has been recognized as a serious health problem in the elderly, it has also increased in young • middle-aged layer. Ginseng is history 2, 000 years Korean typical herbal medicine which is used as a medicinal is known the mystery of Elixir from a long time ago. A previous study was administered ginseng extract results in animal models induced osteoporosis, the bone-related biomarkers, including improved bone density and bone mass.

The investigators performed a 12-week, randomized, double-blind, placebo-controlled human trial to evaluate the efficacy and safety of ginseng extract on improvement of Bone metabolism in menopausal women. The investigators measured Serum Osteocalcin, Urinary Deoxypyridinoline, DPD/OC ratio, Serum CTX, NTX, Ca, Phosphorus, BSALP(vone specific-alkaline phosphatase), P1NP(Procollagen type 1 N-terminal propeptide), WOMAC index(Western Ontario and McMaster Universities Arthritis).

Eligibility Criteria:
Inclusion Criteria:

* age older than 40 years, after a amenorrhea 6 months in women
* T-score less than -1.0,
* osteocalcin 8(ng/mL) or more and DPD 5.2(nMDPD/mMcreatinine) or more,
* subjects giving written informed consent

Exclusion Criteria:

* Diagnosed osteoporosis
* BMI ≤ 18.5kg/m2 or BMI ≥ 30 kg/m2
* Cardiovascular disease, e.g. arrhythmia, heart failure, myocardial infarction, and patient with pacemaker
* History of disease that could interfere with the test products or impede their absorption, such as gastrointestinal disease or gastrointestinal surgery
* Participation in any other clinical trials within past 2 months
* Laboratory test, medical or psychological conditions deemed by the investigators to interfere with successful participation in the study
* Pregnancy or breast feeding etc,.
Education Program for Cardiac Patients

The purpose of this study is to elaborate an educative program that includes telephone follow-up and assess its impact on the perceived health status of patients submitted to percutaneous coronary intervention.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients (18 years or more) of both sexes
* Being submitted to the first coronary artery bypass graft surgery between April 2011 and July 2012
* Having a properly functioning residential phone line

Exclusion Criteria:

* No cognitive condition to participate (assessed through the Mini-Mental State Examination - MMSE)

  * Illiterate participants who did not reach the minimum score 13 on the MMSE
  * Participants with one to seven years of education who did not reach the minimum score 18 on the MMSE
  * Participants with eight or more years of education who did not reach the minimum of 26 points on the MMSE
Clinical Trial of Light Therapy for Epilepsy

This study is designed to investigate whether light therapy may be an effective treatment for some people with epilepsy. Light treatment is already an established treatment for depression. The chemical systems in the brain that are disrupted when someone becomes depressed, overlap with some of those that can be affected during some epileptic seizures. The investigators have designed this study to see whether light therapy may also lead to a decrease in seizures in people who have epilepsy.

The study will be a placebo controlled trial. This means that half of the participants will receive a therapeutic dose of light therapy from a light box, whilst the other half will only receive a placebo light treatment.

The aim of this study is to investigate a new, non invasive treatment for epilepsy that may be useful as an adjunctive therapy for people whose seizures are poorly controlled with anti epileptic drugs. Light therapy is a well established treatment for some forms of depression. From the cellular level to epidemiological studies, there are numerous strands of evidence in the scientific literature that indicate that light therapy could be also an effective treatment for some people with epilepsy.

The proposed study is a randomised placebo controlled trial of light therapy. One hundred people with medically refractory epilepsy will be recruited. Participants will be randomised to receive either therapeutic or placebo doses of light therapy from an identical device for 30 minutes a day during the treatment phase of the study. The statistical power of this study design is \>90% to detect a 25% reduction in seizure frequency during the treatment phase. Although this therapeutic approach is more likely to be palliative than curative, it represents a non invasive and relatively inexpensive add-on treatment option for a sub group of patients who may have reached the end of the road in other medical and surgical treatment options.

Eligibility Criteria:
Inclusion Criteria:

* Adult
* Medically intractable epilepsy
* Min 4 complex partial seizures/ month

Exclusion Criteria:

* Ability to give informed consent
* Underlying progressive neurological condition
Antisocial Behavior: Passing From Parent to Child to Grandchild

Antisocial behavior often occurs in different generations within the same family. However, it is not known what factors contribute to this passing of antisocial behavior from parent to child to grandchild. This study is part of a project evaluating antisocial behavior in families; it focuses on the passage of such behavior from one generation to the next.

While it is well-known that antisocial behavior runs in families, little is known about the specific mechanisms by which it is transmitted from one generation to the next. This prospective study will examine biological influences on transgenerational continuity and change, and how biology interacts with social factors in modulating the transmission of antisocial behavior. The study is unique in that it includes both mothers and fathers, focuses on early mechanisms, and addresses female as well as male antisocial behavior.

This study is part of the continuing Mauritius Child Health Project. The project began by testing 1,795 children age 3 years old on psychophysiological, behavioral, nutritional, and cognitive measures. Both male and female children were tested. Their parents were also assessed for psychosocial influences. One hundred children then participated in a nutritional, exercise, and educational enrichment intervention from ages 3 to 5 years old. The intervention has been shown to increase physiological arousal and attention at age 11 years and to reduce conduct disorder at age 17 years.

These 3-year-old children are now 30-year-old adults. This study will retest these adults on psychophysiological, psychosocial, cognitive, behavioral, parenting, and antisocial behavior measures. Their previously untested spouses will also be assessed. Finally, many of these adults now have 3-year-old children of their own; these children will be evaluated as well. Measures of life stress, daily hassles, family conflict, mental illness, and criminal behavior will be assessed. Data from the enrichment cohort will be evaluated to determine if the intervention disrupted the intergenerational transmission of antisocial behavior from the second to third generations.

Eligibility Criteria:
Inclusion Criteria:

* Child of a participant tested in previous Mauritius Child Health Project studies
Vascular Endothelial Protection Effects of Dextromethorphan

To test the hypothesis that DM could have anti-inflammatory effect and thus achieve vascular protection effect on heavy smokers.

Dextromethorphan (DM), an ingredient widely used in antitussive remedies, had been reported to reduce the inflammation-mediated degeneration of neurons. We recently found that DM can prevent vascular remodeling and neuron injury in animal models of carotid ligation and cerebral ischemia injuries, respectively. It was believed that its action was through the anti-oxidant and NADPH pathway to protect brain cells. However, the mechanism and actual effect on human vascular protection remained unclear.

To test the hypothesis that DM could have anti-inflammatory effect and thus achieve vascular protection effect on heavy smokers, this prospective study will be conducted to treat subjects with heavy smoking history with DM or not and evaluate the anti-inflammatory and the improvement of endothelial function.

Eligibility Criteria:
Inclusion Criteria:

* healthy male volunteers who are currently smoking

Exclusion Criteria:

* personal history of hypertension or diabetes mellitus
* family history with
* documented premature cardiovascular events
* cardiovascular-associated sudden death
* total cholesterol \> 240 mg/dL
* triglyceride \> 200 mg/dL
* low-density lipoprotein \> 160 mg/dL.
The Comparison of Electronic Auscultation Coupled With CALSA and FRI; Repeatability of FRI Biomarkers

CALSA will be compared with FRI and the repeatability of the FRI parameters will be tested in a group of healthy volunteers and asthma patients.

his is a study with no investigational product. CALSA will be compared with FRI and the repeatability of the FRI parameters will be tested in a group of healthy volunteers and asthma patients.

Electronic auscultation of respiratory sounds will be performed, lung function tests (at maximal dilatation) will be executed and computed tomography (CT) scans of the thorax will be taken. The scans will be taken at two different breathing levels, more specifically at total lung capacity (TLC) and functional residual capacity (FRC) level. The scans will be taken while the patient/ volunteer lies down on the movable table of the CT-scan. After the scan is taken it will be asked to the patient/ volunteer to sit upright on the scanning table and to lie down again. When the patient/ volunteer lies down a second CT-scan (TLC and FRC) will be taken.

The objective of this study is to compare CALSA with FRI and to assess the repeatability of FRI biomarkers

Eligibility Criteria:
Inclusion Criteria:

* Male or female patient / volunteer ≥ 18 years old
* Written informed consent obtained
* The subject belongs to 1 of the following groups in the opinion of the investigator:

Group 1: healthy volunteer Group 2: patient with asthma

* Only if patient/ volunteer is a female of childbearing potential: Confirmation that a contraception method was used at least 14 days before visit 1

Exclusion Criteria:

* Pregnant or lactating female
* Patient/ volunteer with an uncontrolled disease or any condition that might, in the judgement of the investigator, place the patient at undue risk or potentially compromise the results or interpretation of the study.

Patient/ volunteer with an uncontrolled disease or any condition that might, in the judgement of the investigator, place the patient at undue risk or potentially compromise the results or interpretation of the study.
Effect of Octreotide on the Colonic Motility in Pediatric Patients

The research study is designed to test how a medication called octreotide affects the motility (contraction or squeezing) of the colon (large intestine). Investigators are investigating whether octreotide can increase contraction and movement in the colon.

As mentioned above.

Eligibility Criteria:
Inclusion Criteria:

* Male or female and undergoing colonic manometry for a routinely accepted indication including: evaluation of chronic constipation, unexplained abdominal distension (Should have had previous diagnostic work up), recurrent fecal impaction, post Hirschsprung's disease repair, chronic intestinal pseudo-obstruction, or suspected colonic dysmotility of any other cause.
* Children aged 12 months or older who are undergoing colonic motility under the supervision of Dr. Joseph Croffie at Riley Hospital.
* In the investigator's judgment, parent(s)/guardian(s) is mentally competent to provide informed consent to participate in the study.

Exclusion Criteria:

* • Subjects with known or suspected allergy to octreotide.

  * Subjects with known prolonged corrected QT interval (QTc) Syndrome or highest risk QTc-Prolonging Agents (including mifepristone).
  * Subjects with known history of ventricular arrhythmia.
  * Subjects with history of any organ transplant who are taking cyclosporine at the time of the motility study.
  * Subjects with history of small bowel transplant.
  * Subjects less than 12 months old.
  * Subjects with severe renal impairment
  * Subjects with severe hepatic impairment
  * Subjects taking bromocriptine, insulin, oral hypoglycemic agents, beta blockers, calcium channel blockers, quinidine, terfenadine, pimozide, sildenafil, tadalafil, and any agents to control fluid and electrolyte imbalance
Multi-Targeted Cardiac Risk Intervention in Type 2 Diabetes

Our study intends to test the efficacy of pharmacist-led group interventions on a weekly basis for 4-weeks, then on a monthly basis for 5 additional months to achieve concomitant reductions in hemoglobin A1c, lipids and blood pressure.

Our project intends to study the 6-month efficacy of a pharmacist-led group intervention program that simultaneously target diabetes, hypertension and dyslipidemia. We hypothesize that pharmacist-led group interventions on a weekly basis for 4-weeks then on a monthly basis for 5 additional months may achieve concomitant reductions in hemoglobin A1c, lipids and blood pressure. We are proposing a pilot randomized controlled study to test the efficacy and feasibility of this approach.

Eligibility Criteria:
Inclusion Criteria:

* type 2 diabetes mellitus,
* \>18 years old,
* with a documented HbA1c more than 7.0%,
* an LDL cholesterol \>100 mg/dl AND a blood pressure \>130/80 mm Hg documented at least once in the medical records within the last 6 months, and
* willing to comply with the study interventions will be eligible for the study.

Exclusion Criteria:

* pregnancy,
* unable to attend the group sessions,
* disease conditions such as psychiatric instability (acutely suicidal, psychotic) or organic brain injury that preclude them from performing diabetes self-care,
* enrolled in the Providence VAMC's Telehealth program
Strategies for Responding to Stress

The purpose of this study is to examine whether changes in psychological and physiological responses differ based on different strategies for responding to stress.

The purpose of this study is to examine whether changes in psychological and physiological responses differ based on different strategies for responding to stress. Different strategies being examined in this study include exercise and arousal reappraisal.

Eligibility Criteria:
Inclusion Criteria:

* Males and females ages 18 to 35
* Speaks English fluently
* Passes the Physical Activity Readiness Questionnaire-Plus
* Mild to Moderate depression symptoms as measured by the Beck Depression Inventory-II (a score ≥14 but ≤25)

Exclusion Criteria:

* Hearing or visually impaired such that it will interfere with ability to participate effectively
* Currently exercising regularly, defined as exercising at a moderate-intensity more than 2 times a week, for at least 20 minutes each time.
A Study of Chenodeoxycholic Acid (CDCA) in Newly Diagnosed Participants With Cerebrotendinous Xanthomatosis (CTX)

This study is designed to demonstrate the beneficial effect of CDCA in the treatment of CTX-associated diarrhea in approximately 10 participants aged 2-75 years old with newly diagnosed CTX or suspected CTX who have never received treatment with CDCA.


Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent form (or assent form as appliable)
* Aged from 2 to 75 years old
* Has a new or suspected diagnosis of CTX as defined by an elevated plasma cholestanol concentration (\>10 mg/L/\>25.7 μmol/L) in conjunction with a clinical presentation consistent with the diseased as assessed by the investigator
* Has never received treatment with CDCA
* Has never received treatment with other bile acid products

Exclusion Criteria:

* Any medical condition that, in the opinion of the investigator, precludes the participant's participation in the study
* Presence of known hepatocyte dysfunction or bile ductal abnormalities such as intrahepatic cholestasis, primary biliary cirrhosis or sclerosing cholangitis
* Inability to adhere to treatment and visit schedule
* Female participants who are pregnant
* Female participants who are breast feeding
* Female participants who are using estrogen-containing compounds and cannot/will not discontinue them for the duration of the study
* Female participants of childbearing potential who are not using locally approved birth control method(s) or double barrier contraception (ie, condom and diaphragm, condom or diaphragm and spermicidal gel or foam)
* Taking any of the following medications: bile acid products; inhibitors of bile acid transporters; bile acid binding resins; aluminum-based antacids; coumarin and its derivatives; cholestyramine; ciclosporin; sirolimus; or phenobarbital
Effect of Exercise on Disease Activity and Cardiovascular Risk Factors in Patients With Ankylosing Spondylitis

Background:

Exercise is recommended as a cornerstone in the treatment of ankylosing spondylitis together with medication. Last years, increased risk of cardiovascular diseases in patient with inflammatory diseases is reported, probably caused by inflammation and increased prevalence of traditional risk factors. In both healthy adults and other patient groups, cardiorespiratory and muscular strength exercises have been shown to have a positive effect on inflammation as well as on cardiovascular risk factors. To our knowledge this has not been shown in patients with ankylosing spondylitis.

Objective: The aim of this study is to investigate the effects of a cardiorespiratory and muscular strength exercise program on disease activity and cardiovascular risk factors in patients with ankylosing spondylitis


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of ankylosing spondylitis, confirmed by a rheumatologist
* Age, 18-70 years
* Not using TNF-α medication or steady medication for ≥3 months
* Disease activity ≥2.1 on ankylosing spondylitis disease activity score defined as high disease activity
* Not participated in a structured cardiorespiratory or muscle strengthening exercise program during the last year (\>60 min once per week), including large amounts of brisk walking (\>120 min per week)

Exclusion Criteria:

* Known cardiovascular disease
* Severe comorbidity which involves reduced exercise capacity
* Not able to participate in weekly exercises sessions in Oslo
* Pregnancy
SBRT for Breast Cancer Oligometastases

This is a prospective data collection of treatment outcome for newly diagnosed oligometastatic breast cancers with 1-3 bone metastases. Eligible patients will be identified from the weekly Breast MDC. Patients will receive the recommended systemic and local treatment (including metastases directed SBRT) according to our clinical practice guidelines.Patients will be followed according to our routine with clinical and radiologic assessment. It is preferred that the same imaging method that was used to originally detect the metastases be used in follow-up assessments. The first imaging for SBRT sites will be three months post SBRT and every three months for the first year, every 6 months for the second year, then annually. Response and progression for these metastases will be evaluated using the revised Response Evaluation Criteria in Solid Tumors (RECIST) guideline (version 1.1). Changes in the largest diameter (unidimensional measurement) of the tumor lesions is used in the RECIST criteria. If functional imaging (bone scan, PET) were used at staging, changes in the uptake will be used in follow up scans to determine response to treatment and progression. As for SBRT related morbidities, we will use the Common Terminology Criteria for Adverse Events (CTCAE v5) for toxicity reporting and scoring.


Eligibility Criteria:
Inclusion Criteria:

* Women \>18 years old with a pathologically proven breast cancer who present with 1-3 bone metastases will be included.
* Metastases need to be confirmed pathologically if possible, otherwise two different imaging modalities (CTor MRI and bone scan or PET) are needed to confirm metastases.
* Patients should be able to receive the recommended local and systemic treatment and the primary tumor must be controlled at time of SBRT.
* Maximum diameter of individual metastasis metastasis in any dimension ≤ 5 cm; and must be \>5 cm away from each other (defined as Edge to Edge of tumor).

Exclusion Criteria:

* Non bone metastatic breast cancers
* Prior history of radiotherapy to same sites of SBRT
* Pathologic fractures of involved bones
* Contraindications to radiotherapy including pregnancy and connective tissue disease.
* Patients with impaired cognitive functions.
Fermented Milk Drink on Human Intestinal Microflora

Fermented milk is a popular drink. Recent studies revealed that some fermented milk containing some strains of lactic acid bacteria have health-promoting effects through improvement of the intestinal microflora and modulation of the immune system. Lactobacillus casei strain Shirota (LcS) is a probiotic bacterium used in the production of fermented milk products and lactic acid bacteria preparations. LcS has been shown to modify allergen-induced immune responses in allergic rhinitis, altering fermentation patterns in the small bowel, prevention of recurrent urinary tract infections in women. Yakult®300 is a fermented milk containing at least 3x10\^10 live LcS cells per 100 ml bottle. This study aimed to evaluate the effects of a fermented milk drink containing Lactobacillus casei strain Shirota on the human intestinal microflora.


Eligibility Criteria:
Inclusion Criteria:

* Healthy adult volunteers and willing to give voluntary written informed consent

Exclusion Criteria:

* Major systemic disease
* Pregnancy, parturient and feeding woman, or expect to be pregnant
* Abnormal liver function
* Abnormal renal function
* Abnormal gastrointestinal function
* Take medication for gastrointestinal function
* Stroke, myocardial infarction,
* Poor compliance for study protocol
Pilot Study to Evaluate the Effect of Two Microalgae Consumption on Metabolic Syndrome

The purpose of this study is to evaluate the effect of the consumption of two microalgae Chlorella vulgaris and Arthrospira platensis (Spirulina) on some biomarkers of metabolic syndrome: Total cholesterol, HDL cholesterol, LDL cholesterol, triglycerides, Apolipoprotein A and Apolipoprotein B, in overweight / obese subjects with altered lipid profile.

A randomized, parallel, and double-blind pilot study with 3 study arms is being performed to evaluate the effect of the consumption of two unicellular microalgae: Chlorella vulgaris and Arthrospira platensis (Spirulina).

The investigators included 30 participants between 18 and 65 years (BMI ≥25 and \<40 kg / m2). All volunteers will be randomized into 3 study groups, and participants will receive the 3 different study products during 30 days.

Eligibility Criteria:
Inclusion Criteria:

* Men and women from 18 to 65 years old.
* Body Mass Index (BMI) ≥25 and \<40 kg/m2.
* Cardiovascular risk \<10%
* Adequate cultural level and understanding
* Agree to participate in the study

Exclusion Criteria:

* Subjects with BMI ≥40 or \<25 kg /m2
* Subjects diagnosed with Diabetes Mellitus.
* Subjects with dyslipidemia on pharmacological treatment
* Subjects with hypertension on pharmacological treatment
* Subjects with established diagnosis of eating disorder
* Smokers or those subjects with high alcohol consumption
* Subjects under pharmacological treatment
* Subjects with large weight fluctuations of more than 4 kg or who have undergone in six months a weight loss diet
* Subjects with sensory problems
* Subjects with gastrointestinal diseases that affect the digestion or absorption of nutrients
* Pregnant or breastfeeding women
* Women with menstrual irregularities
* Subjects with intense physical activity
* Subjects with food allergies to meals included in breakfast, study product or lunch or that reject their consumption
* Subjects with a diagnosis of celiac disease or a gluten intolerance