cyrilzakka/clinical-trials huggingface dataset:
Understanding Motivation Towards Exercise to Enhance Physical Activity on Prescription Adherence - Feasibility Study

The goal of this clinical trial is to explore feasibility and evaluate methods to investigate changes in physical activity, function and psychometrics in relation to an exercise intervention in physically inactive middle-aged men and women. The main questions it aims to answer are:

* Is the exercise intervention feasible regarding retention and user experience?
* Is the evaluation methods on physical activity, function and psychometrics suitable for the present study?
* Is there an intervention effect in physical activity, function and psychometrics at three and six month post baseline?
* Can barriers and facilitators towards increased physical activity be identified in the two groups of the study?

All participants will first receive standard care for physically inactive patients, i.e. Physical activity on Prescription (PaP), followed by allocation to an exercise intervention (EI) group. The EI group will be offered an additional exercise intervention for 12 weeks consisting of 1-2 training sessions per week of a combination of aerobic and resistance training at a private fitness center.

Feasibility of the exercise intervention will be evaluated based on retention rates and user experience.

Additionally, researchers will assess physical activity, function and psychometrics in the EI group at three and six months to evaluate the suitability of the chosen methods and to get preliminary data on the intervention effect. Finally, interviews with the participants in the control and EI groups will be performed at the end of the study in order to explore barriers and facilitators towards increased physical activity in formally inactive patients.

Edit after registration of the study: Due to a lower number of recruited participants than expected (20 instead of the anticipated 30), the protocol was updated by removing the control group that would initially consist of 10 participants. The remaining 20 participants were all allocated to the exercise intervention group to assess feasibility of the intervention.


Eligibility Criteria:
Inclusion Criteria:

* Physically inactive persons as defined as not meeting the current recommendations of at least 150 minutes of moderate to vigorous physical activity per week. This criterion is self-assessed by potential participants.
* Age 40-60 years

Exclusion Criteria:

* Physical disability that affects the ability to perform the exercise intervention.
* Heart failure or severe degenerative disease, e.g. malignant cancer, multiple sclerosis etc.
* Myocardial infarction or stroke during the last 12 months.
* Heart conditions including angina pectoris that is worsened with exercise.
* Neuromuscular, musculoskeletal, or rheumatic conditions that is worsened with exercise.
* Hypertension grade III, i.e. systolic blood pressure above 180 mmHg and/or diastolic blood pressure over 110 mmHg.
PREPARE: A Randomized Trial of a Pre-pregnancy Weight Loss Intervention

The US obesity epidemic is being transmitted to the next generation. Growing evidence suggests that both a mothers' weight at pregnancy onset, and excessive weight gain during pregnancy, are associated with increased risk of pregnancy-related complications such as gestational diabetes and pre-eclampsia, and an increased risk that her child will become obese and face obesity-related health issues in later life.

Currently, over one-third of reproductive-aged women in the U.S. are obese \[body mass index (BMI) ≥ 30\]. Our research team has shown that we can improve birth weight outcomes in babies of obese women who start a weight-management intervention program at 14 to 15 weeks of their pregnancy (soon after their first prenatal visit). However, organogenesis and metabolic programming begin early in the first trimester, well before the first prenatal visit. Therefore, waiting to address mothers' weight, physical activity, and diet quality until the first prenatal visit is not optimal. Given the need to reach overweight and obese women prior to pregnancy, and the Institute of Medicine's (IOM's) recent recommendation, based on observational studies, that women should reach a healthy weight before conceiving, this randomized clinical trial will evaluate a comprehensive preconception weight loss program.

The goals are to help overweight and obese women (BMI ≥ 27) who are considering pregnancy to adopt improved dietary and physical activity habits and lose weight prior to becoming pregnant, and then help them maintain those habits and prevent excessive weight gain during their pregnancy. We model this intervention after successful, frequent-contact interventions designed by ourselves and other investigators. We start with face-to-face counseling followed by frequent telephone counseling contacts. The expected outcomes for mothers include reduced pregnancy-related weight gain (primary) and lower weight at the start of pregnancy (secondary) and for babies, decreased risk of exceeding national norms for weight at birth (secondary).

Eligibility Criteria:
Inclusion Criteria:

* Current Kaiser Permanente Northwest (KPNW) member
* Expects to be KPNW member for at least 2 more years
* Body Mass Index (BMI) ≥ 27
* Not currently pregnant
* Access to computer with Internet
* Completion of screening diet assessment
* English speaking

Exclusion Criteria:

* Taking medication (insulin or pills) for treatment of diabetes
* Gastrointestinal disease requiring special diet or medications (for example, ulcerative colitis, celiac sprue, phenylketonuria)
* Currently receiving treatment for cancer
* Renal disease (kidney disease requiring special diet or medication)
* History of bariatric surgery
* Use of prescription weight loss medications in the last three months
* Another household member already participating in the Prepare study
Effect of Su Jok Therapy on Breastfeeding

There are many alternative methods to increase breast milk. In the literature, studies on Su Jok therapy applications are limited and no studies on increasing breast milk have been found. In Korean language, 'Su' means hand and 'Jok' means foot. Su Jok therapy is defined as a modern acupressure/acupuncture interpretation that utilises the body's independent communication systems on the hands and feet by applying various techniques such as massage, moxa (heating), needles, magnets and seeds to the reflection points on the hands and feet. Su Jok is an integrated therapy that incorporates many tried and trusted methods of oriental medicine

There are many alternative methods to increase breast milk. In the literature, studies on Su Jok therapy applications are limited and no studies on increasing breast milk have been found. In Korean language, 'Su' means hand and 'Jok' means foot. Su Jok therapy is defined as a modern acupressure/acupuncture interpretation that utilises the body's independent communication systems on the hands and feet by applying various techniques such as massage, moxa (heating), needles, magnets and seeds to the reflection points on the hands and feet. Su Jok is an integrated therapy that incorporates many tried and trusted methods of oriental medicine.

Eligibility Criteria:
Inclusion Criteria:

* primiparous women giving birth by caesarean section,
* women aged 19-35,
* breastfeeding women

Exclusion Criteria:

* those who refused to participate in the research
A Study to Prevent Infantile Spasms Relapse

After initially successful treatment, many children with infantile spasms unfortunately have a relapse, and relapse is linked to poor long-term outcomes such as autism and other forms of epilepsy. The aim of this study is to determine if treatment with low-dose prednisolone is safe, well tolerated, and effective in reducing the risk of relapse.

In this study, the investigators will enroll infants who have responded to standard therapy for treatment of Infantile Epileptic Spasms Syndrome (IESS). Patients will be randomized to receive either low-dose prednsiolone or placebo for 4 months. During the first 7 months, patients will be evaluated monthly, with clinic visits and electroencephalography (EEG). Patients will then return for a final visit at age 2 years. Key outcomes will be determination of IESS relapse, emergence of other types of seizures/epilepsy, and evaluation of developmental/behavioral status at age 2 years. We will attempt to determine whether or not the prednisolone intervention reduces the risk of any adverse outcome, but this may not be possible given the study design. We will also evaluate the feasibility of the intervention, study procedures, and recruitment.

Eligibility Criteria:
Inclusion Criteria:

1. Age 2 to 18 months, inclusive
2. Clinical diagnosis of infantile spasms syndrome, with EEG-confirmed complete response to standard treatment (prednisolone, ACTH, and/or vigabatrin)

Exclusion Criteria:

1. Presence of clinically significant hypertension, infection, or any other diagnosis which poses unreasonable risk in the setting of extended corticosteroid therapy, in the view of the study physician
2. Exposure to any artisanal cannabinoid product within 14 days of screening
3. Ongoing therapy with the ketogenic diet
4. Implantation of a vagal nerve stimulator within 3 months of screening, or any change in stimulation parameters within 1 month of screening
5. Treatment of IESS via epilepsy surgery
Hematological Infection Score Compared to the Hospital Standard for Diagnosis of SIRS or Sepsis on ICU

CRP and PCT are not valid parameters of early infection in particularly postoperative patients. (Sanders et al., A\&A, June 2006, Vol.102; Katja et al., Shock, February 2001, Vol 15.2) Better detection systems for SIRS and sepsis are urgently required.

ICIS® (Sysmex intensive care infection score) and ICPS® (Sysmex intensive care prognostic score) are two new score-systems depending on detectable cellular response of the innate immune system in human peripheral blood.

The purpose of this observational study is to determine if these scores are superior in early differentiation between non-infectious SIRS and infectious SIRS (sepsis) in postoperative patients. Furthermore, the applicability of the scores for triggering start and ending of anti-infective therapy will be examined.


Eligibility Criteria:
Inclusion Criteria:

* all ICU patients age \> 18 years
* more than 36h on ICU

Exclusion Criteria:

* ICU patients age \< 18 years
* less than 36h on ICU
Interim PET/CT Guided Cycle Numbers of R-CHOP in DLBCL

The aim of this study is to optimize the number of cycles of R-CHOP in patients with diffuse large B-cell lymphoma based on the interim results of PET/CT.

R-CHOP is the standard regimen for patients with diffuse large B-cell lymphoma (DLBCL). However, the standard number of cycles is uncertain. Recently, interim PET/CT was found to predict prognosis in DLBCL. The hypothesis of this study is to optimize the number of cycles based on the interim results of PET/CT in order to avoid treatment exposure.

Eligibility Criteria:
Inclusion Criteria:

* Previously untreated diffuse large B-cell lymphoma
* Age range 18-80 years old
* Eastern Cooperative Oncology Group performance status 0-2
* Life expectancy of more than 3 months
* Adequate organ function

Exclusion Criteria:

* Primary or secondary central nervous system involvement
* Previous serious cardiac disease
* History of other malignancies except cured basal cell carcinoma of skin and carcinoma in-situ of uterine cervix
* Pregnant or lactating women
* Serious uncontrolled diseases and intercurrent infection
Role of New Adipokines and Hepatokines in Prediction of Patients With Metabolic Syndrome or NAFLD

To investigate the predictive roles of adipokines and hepatokines to detect non-alcoholic fatty liver disease (NAFLD), diabetes, or dyslipidmia.

To examine the association or effects of clinical and biochemical factors (lab results and medication, etc.) on serum levels of adipokines and hepatokines in certain subjects with non-alcoholic fatty liver disease (NAFLD), diabetes, or dyslipidmia.


Eligibility Criteria:
Inclusion Criteria:

1. dyslipidemia 1. serum triglyceride≥150mg/dl, or taking medication to lower triglyceride levels (e.g. fibrates, niacin, omega-3, etc.) or 2. serum LDL-C≥100mg/dl, or taking medication to lower LDL-C levels (e.g. statin, ezetimibe, etc.)
2. type 2 diabetes 1. defined according to the ADA guideline (DM definition) or 2. taking any anti-diabetic medications
3. non-alcoholic fatty liver disease (NAFLD) 1. diagnosed as having fatty liver by ultrasonogram or 2. diagnosed as having fatty liver by transient elastogram (Fibroscan) or 3. diagnosed as having fatty liver by abdomina CT scan
4. Normal control 1. should not be included in other groups as above and 2. not taking any medication related to diabetes and dyslipidemia and 3. BMI \<25kg/m2

Exclusion Criteria:

1. subjects who refused to agree with informed consents
2. subjects with organ-transplantation
3. serum creatinine ≥1.5mg/dl
4. pregnant women
5. liver cancer or pancreatic cancer
6. subjects with chronic hepatitis B or C virus infection
7. for NAFLD group, subjects with excessive alcohol consumption (men: ≥210g of alcohol per week, women: ≥140g of alcohol per week)
A Study to Evaluate the Effects of Asoprisnil(J867) in Women With Uterine Fibroids Who Are Scheduled for a Hysterectomy

The objective of this study is to evaluate the effects of 10 mg and 25 mg doses of asoprisnil, compared to placebo, taken daily for 12 weeks, on uterine blood flow and the morphology of the endometrium and uterine fibroids.

No medical therapy is currently available for the long-term treatment of uterine fibroids. The objective of this study is to determine the effects of asoprisnil in uterine fibroid growth suppression. Full thickness biopsies obtained from surgical procedures will allow the assessment of asoprisnil's effects on the basalis, the myometrium, and on endometrial angiogenesis. Various other exploratory immunohistological and biochemical specimens will be collected to evaluate the mechanisms of action of asoprisnil in the endometrium, the myometrium, and in uterine fibroids.

Eligibility Criteria:
Inclusion Criteria:

* Premenopausal women, at least 18 years of age
* Diagnosis of uterine fibroid(s), confirmed by ultrasound
* History of menstrual cycles between 17 and 42 days
* Otherwise in good health
* Scheduled for a hysterectomy at the end of the treatment period
* Negative pregnancy test
* Agrees to double barrier method of contraception
* Pap test with no evidence of malignancy or pre-malignant changes
* Endometrial biopsy with no significant histological disorder

Exclusion Criteria:

* Less than 3 months after having a baby or breast-feeding
* Any abnormal lab or procedure result the study-doctor considers important
* Severe reaction(s) to or are currently using any hormone therapy
* History of cancer or alcohol or drug abuse
* Diagnosis of Polycystic Ovary Syndrome
* History of prolactinoma
* Current use of Intrauterine Device
* Significant gynecological disorder
* Uterine size \> 32 weeks gestation
* Current diagnosis of endometriosis
* Uterine artery embolization within 6 months
Lipoprotein Metabolism in Normal Volunteers and Patients With Abnormal Levels of Lipoproteins

Researchers plan to study the fat-rich particles, called lipoproteins, which circulate in the blood. This study is designed to improve understanding of normal, as well as abnormal, lipoprotein metabolism and the role it plays in the development of hardening of the arteries (atherosclerosis).

Patients participating in this study will receive an intravenous (directly into the vein) injection of a small amount of specially prepared amino acids. The amino acids being injected are the same amino acids present in a normal diet. The amount of amino acid given will be less than the amount eaten in a protein-rich meal. The amino acids will be labeled with nonradioactive heavy isotopes which are also present in the environment n low amounts.

Patients participating in the study will be required to have blood samples taken, and provide urine samples throughout the course of the study. In addition, patient will be required to follow a specially formulated diet. Patients will be weighed throughout the course of the study.

Apolipoproteins regulate the metabolism of lipids and lipoproteins in plasma of humans. In order to investigate the roles of apolipoproteins in these processes, we plan to quantitate the kinetics of the metabolism of apolipoproteins utilizing nonradioactive isotope labeled amino-acids.

Eligibility Criteria:
The subjects for these investigations will be either healthy normal volunteer control subjects or patients who have a dyslipoproteinemia.

Subjects must be 18-80 years old.
PANORAMA 2 Observational Study

Understanding the clinical practice of treatment of cardiac rhythm disorders all over the world and understanding the clinical outcomes of the treatment with its cardiac rhythm products in real world patient population is essential for Medtronic to be able to effectively develop new products and adjust existing products. In addition Medtronic is committed to monitor the safety of its products throughout the entire life cycle to ensure maximum product reliability.

The Panorama 2 registry will enable Medtronic to increase data collection of clinical practice with Medtronic implantable Cardiac Rhythm and Disease Management (CRDM) devices in various regions across the world and on product reliability of its CRDM devices.


Eligibility Criteria:
Inclusion criteria:

* Patient is 18 years of age or older (lower age limit dependent on local law: to be specified in country-specific addendum to the clinical investigational plan, if applicable)
* Patient or Legally Authorized Representative provides signed and dated authorization and/or consent per institution and local requirements
* Patient will be treated with a commercially available implantable Medtronic CRDM device/ Vitatron device within maximally 30 days after enrollment or within 3 days prior to enrollment

Exclusion criterion:

• Patient has exclusion criteria per local law (to be specified in country-specific addendum to the clinical investigational plan, if applicable)
Study Evaluating the Efficacy and Safety of Miconazole Nitrate + Domiphen Bromide Vaginal Cream in the Treatment of Subjects With Acute Vulvovaginal Candidiasis

This study is a multicentre, three-arm, double-blind, randomized controlled, parallel-group, comparative phase II clinical trial to evaluate miconazole nitrate 2% + domiphen bromide vaginal cream in subjects with acute vulvovaginal candidiasis.

Females aged 18-50 years with a clinical diagnosis of an acute VVC episode at Screening Visit will be randomly assigned to either miconazole nitrate 2% + low or high dose of domiphen bromide vaginal cream or to the comparator product Gyno-Daktarin® vaginal cream (miconazole nitrate 2%). The creams will be applied for 7 days and subjects will be followed up for 12 weeks.

Eligibility Criteria:
Main inclusion criteria:

1. Subjects must be generally healthy, non-pregnant females, 18-50 years of age at Screening Visit.
2. Subjects must have an acute VVC episode at Screening Visit, defined as a total signs and symptoms score of ≥3 and a positive KOH wet mount preparation or Gram stain from a vaginal smear revealing filamentous hyphae/pseudohyphae and/or budding yeast cells.

Main exclusion criteria :

1. Subjects with the presence of concomitant vulvovaginitis caused by other pathogens at Screening Visit, or any other infection that requires antibiotic treatment.
2. Subjects with visible condylomas on vulvovaginal examination at Screening Visit.
3. Subjects with the presence or a history of another vaginal or vulvar condition(s) that in the Investigator's opinion would confound the interpretation of the clinical response.
4. Subjects with a history of cervical cancer.
Standard Clopidogrel Versus Prasugrel Low Dose Therapy in Elderly Patients With Acute Coronary Syndrome

The elderly represent a growing segment of the coronary population treated by dual antiplatelet therapy for percutaneous coronary intervention (PCI). These patients bear a higher risk of both ischemic events and bleeding complications than younger patients, with a subsequently higher rate of mortality.Recentprogress in antithrombotic treatment demonstrated the efficacy of adding a P2Y12 receptor antagonist to low-dose aspirin. Whether this benefit is also present in the elderly remains a debated issue due to the lack of specific data in this sub-population. The present study was realized to provide specific data on platelet response to clopidogrel, standard dose (75 mg) or prasugrel 5 mg in elderly patients (≥75 years old) whereas the superiority in PR response of the latter should allows the Prasugrel therapy in elderly patients with the better clinical efficacy and therapeutical safety already showed compared with Clopidogrel.


Eligibility Criteria:
Inclusion Criteria:

* Acute coronary syndrome
* PCI with stent implantation
* clopidogrel responsiveness
* \> 75 years of age.

Exclusion Criteria:

* history of bleeding diathesis
* chronic oral anticoagulation treatment
* contraindications to antiplatelet therapy
* PCI or coronary artery bypass grafting (CABG) \< 3 months
* hemodynamic instability
* platelet count \< 100,000/μl
* hematocrit \< 30%
* creatinine clearance \< 25 ml/min
* Patients with a history of stroke
* other contraindication for prasugrel administration
* patients weighing \< 60 kg
* high on treatment platelet reactivity
Bacillus Coagulans Effect on Gastrointestinal Function in Healthy Adults.

A single centre, double-blind, placebo-controlled study to evaluate the effect of the consumption of Bacillus coagulans at a daily dose of 1 x 10⁹ CFU on bowel habits, intestinal microbiota and gastrointestinal symptoms in healthy adults.


Eligibility Criteria:
Inclusion Criteria:

1- Adults male or female aged 18-65 years old. 2- Generally healthy but with irregular bowel movements, including \&lt;4 stools/week or periodic (over 2/week) loose stools 2- Agreed not to take other probiotics or prebiotics products during the study period, unless specified by the investigator.

3- Subjects enrolled in the study voluntarily and signed the Consent Form.

Exclusion Criteria:

1. Subjects aged \&lt;18 or \&gt; 65 years, pregnant or lactating women, and those who are susceptible to allergens or have food allergies.
2. Subjects with cardiovascular, cerebrovascular, hepatic, renal, hematopoietic diseases or endocrine diseases, and or mental illness.
3. Subjects with constipation symptoms caused by surgical operation within the past 30 days; subjects with acute GI track diseases in the past 30 days; subjects with constipation symptoms due to severe organ lesion (colon cancer, severe enteritis, intestinal obstruction, inflammatory bowel disease, etc.)
4. Subjects who could not eat orally or take the study products as prescribed or cannot comply with the protocol.
5. Subjects administered relevant products recently, which would affect the outcome of the study.
6. Subjects who took probiotics or prebiotics products (including yogurt, beverages or foods containing probiotics) within the past month, which may affect the results of the study.
7. Subjects who suffered from gastrointestinal disease within the past month.
8. Subjects who had taken antibiotics in the past month.
9. Subjects who had not taken the test product as prescribed or took other supplements or drugs.
10. Subjects with incomplete data or incomplete information, so that the efficacy could not be estimated.