cyrilzakka/clinical-trials huggingface dataset:
Effect of Soy Isoflavones on Bone Mineral Density and Physical Performance Indices

The aim of the present study was to investigate the effects of soy and soy plus isoflavones on bone mineral Density and physical performance in post menopausal women.

Post menopausal estrogen deficiency causes physiologic changes in body composition including decreased lean body weight and bone mass. A decrease in muscle strength along with osteoporosis puts post menopausal women at a high risk of hip fractures causing considerable mortality and morbidity. Estrogen use has been shown to reduce bone density loss and increase muscle strength but given the concerns regarding its use, patients are looking for alternatives such as Soy isoflavones. Most human studies on the effect of Soy on bone mineral density (BMD) in post menopausal women have been short term i.e. 3-6 months and failed to provide conclusive evidence. There is no evidence of its effects on physical performance.

The aim of the present study is to investigate the effects of 25g of soy protein alone or with 90mg of isoflavones on bone mineral Density and physical performance indices in post menopausal women over a duration of 2 years.

Eligibility Criteria:
Inclusion Criteria:

* at least 55-75 years of age
* at least 7 years post menopausal either spontaneous or surgical

Exclusion Criteria:

* must not have used estrogen for atleast 2 months prior to entering study
* must be on no bone active drugs such as bisphosphonates, anti convulsants, calcitonin and long term steroids
* osteoporosis (T-score\<-2.5)
* BMI \<18 or \>34
Registry for Participants With Short Bowel Syndrome

This is a global prospective, observational, multi-center registry to evaluate the long-term safety profile for participants with short bowel syndrome (SBS) who are treated with teduglutide in a routine clinical setting. The registry will also evaluate the long-term clinical outcomes in participants with SBS. SBS participants treated and not treated with teduglutide will be enrolled.


Eligibility Criteria:
Inclusion Criteria:

1. Male and female participants, of any age, with a diagnosis of short bowel syndrome (SBS).
2. Signed informed consent and medical records release by the participant or a legally acceptable representative
3. Participants who have never received teduglutide treatment must be on parenteral nutrition (PN)/intravenous (IV) fluids support for at least 6 months at the time of enrollment.

Exclusion criteria:

1. Participants currently participating in a blinded clinical trial or their extension studies.
2. Participants who have never been on PN/IV support.
3. Participants who are currently or previously exposed to any Glucagon-like peptide 2 (GLP-2) analogs other than teduglutide.
(Botox) Mechanisms of Action in Altering the Molecular Environment in Which Pain Fibers Exist

To compare Botox-treated and Botox-untreated symptomatic tissues (defined as areas where the head hurts and the pain is felt) of chronic migraine (CM) patients using molecular studies.

Eligible patients for migraine surgery will be injected unilaterally with Botox prior to surgery. The effects of Botox on tissues will be evaluated.

Eligibility Criteria:
Inclusion Criteria:

* Age 18-65 years
* Diagnosis of Chronic Migraine consistent with International Classification of Headache Disorders (ICHD-III) criteria, with a history of bilateral headache pain and chronic tenderness in neck muscles
* Patient is capable and willing to provide informed consent
* Female subjects of child bearing potential must have a negative pregnancy test at enrollment and agree to remain abstinent or use acceptable methods of birth control (i.e., hormonal contraceptives, inrauterine device, diaphragm with spermicide, cervical cap or sponge, condoms or partner has had a vasectomy) for three months following injections of Botox
* Patients referred by their primary Neurologist to the study surgeon and who are determined to be candidates for surgical decompression of extracranial sensory nerves.
* Patient agrees to abstain from protocol-specific excluded medications beginning 14 days prior to the decompression surgery.

Exclusion Criteria:

* Patient has hypersensitivity reactions or other intolerance to Botox
* Patient is pregnant or trying to become pregnant with the timeframe of the study.
* Infection at proposed injection sites.
Clinical Evaluation of a Short Illumination Duration (35 Minutes) When Performing PDT of AK Using the Dermaris ®

This clinical study aims aims to evaluate the clinical outcomes of SDL-PDT (simulated daylight Photodynamic Therapy) using the Dermaris in patients treated for AK lesions of the scalp at our medical dermatology center using only 35 minutes low-intensity light exposure.

25 patients, with phototype 1 to 3, with grade I-II AK of the scalp will be treated. Only patients with a minimum of 9 clinically diagnosed grade I and II AK lesions of the scalp (according to the classification of Olsen) suggesting the existence of field cancerization, will treated with SDL-PDT (simulated daylight Photodynamic Therapy) using the Dermaris® (Surgiris, France) and therefore included in the study after application of MAL cream (Metvix ®, Galderma, Switzerland) to the treatment area. After debridment of all treated areas with sandpaper, Metvix will be applied and illuminated with with Dermaris 10 minutes later (leading to drug-light interval (DLI) of 10 minutes) with an irradiance of 2.9 mW/cm2 and a duration of 35 minutes The primary endpoint will be the rate of patients with less than two AK lesions at six-month post-treatment. Secondary endpoints will include scores of pain, erythema, crusts, discomfort and during or/and post the treatment.

A ﬁrst follow-up visit will be scheduled seven days after the treatment. At this visit, crusts will be clinically rated by a dermatologist, while patients scored discomfort they had experienced during the six-day post-treatment. At the second follow-up visit conducted three months after the treatment, AK lesions will be counted by a dermatologist without differentiation between new and recurrent lesions. A second SDL-PDT using the Dermaris will be performed on the day if AK lesions are still present. At last, in case of remaining AK observed at 6 month follow up, a third treatment session with the same parameters will be carried out.

The study is approved by the Ethical clinical committee of the Centre Dermatologique du Roy and conducted in accordance with the ethical principles of the Declaration of Helsinki (2008) and the International Conference on Harmonisation - Good Clinical Practices and in compliance with local regulatory requirements.

Eligibility Criteria:
Inclusion Criteria:

* phototype 1 to 3,
* grade I-II AK of the scalp
* minimum of 9 clinically diagnosed grade I and II AK lesions of the scalp (according to the classification of Olsen) suggesting the existence of field cancerization

Exclusion Criteria:

* serious organic disorder,
* incipient or established cognitive impairment
* pregnancy
* lactation,
* to be receiving oral or parenteral pharmacological therapy which might interfere with the results.
Kinesiotaping the Hand in Cerebral Palsy

BACKROUNDS: Thumb in palm deformity restricts hand function by prevent somatosensory input in the children with cerebral palsy who have spasticity in their hands.

OBJECTİVES: To investigate the effects of thenar palmar kinesiotape application with and without pressure on hand function in children with cerebral palsy. METHOD: 45 children were randomly allocated to one of the thenar taping groups either with or without pressure or to the control group. Nine hole peg test and nine parts puzzle test were used to measure hand function. The two study groups were evaluated initially, with taping 20 minutes later and 20 minutes after taping was removed.

BACKROUNDS: Thumb in palm deformity restricts hand function by prevent somatosensory input in the children with cerebral palsy who have spasticity in their hands.

OBJECTİVES: To investigate the effects of thenar palmar kinesiotape application with and without pressure on upper extremity function in children with cerebral palsy. METHOD: 45 children were randomly allocated to one of the thenar taping groups either with or without pressure or to the control group. Nine hole peg test and nine parts puzzle test were used to measure upper extremity function. The two study groups were evaluated initially, with taping 20 minutes later and 20 minutes after taping was removed.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of Cerebral Palsy
* Stable clinical status
* Hand and/ or wrist spasticity
* No passive movement limitation
* Receiving regular neurodevelopmental rehabilitation
* Sufficient cognitive level

Exclusion criteria:

* Surgery of the upper extremity
* Orthotic treatment
* Sensory deficit
A Drug-Drug Interaction Study of Orforglipron (LY3502970) in Healthy Overweight and Obese Participants

The main purpose of this study is to determine effect of orforglipron capsule formulation on the amount of digoxin, rosuvastatin, acetaminophen, midazolam, and simvastatin (each given alone and together with orforglipron) that enters the bloodstream and how long it takes the body to eliminate them when administered orally in healthy overweight and obese participants. In addition, the effect of the orforglipron tablet on the amount of simvastatin that enters the bloodstream and how long it takes the body to eliminate it will be evaluated.

The study will also assess the effect of sodium bicarbonate when administered alone with simvastatin versus orforglipron capsule containing sodium bicarbonate administered with simvastatin. The safety and tolerability of orforglipron and information about any side effects experienced will be collected.

Study will be conducted in two parts, with part 1 and 2 lasting up to approximately 23 and 24 weeks each, including the screening period.


Eligibility Criteria:
Inclusion Criteria:

* Participants who are overtly healthy as determined by medical history and physical examination.
* Have body mass index (BMI) equal to or greater than 27 kilograms per meter squared (kg/m²), inclusive, at screening.
* Have an estimated glomerular filtration rate equal to or greater than 60 milliliters per minute (mL/min).
* Males and females who agree to follow contraceptive requirements, or women not of childbearing potential (WNOCBP).
* Have venous access sufficient to allow for blood sampling.

Exclusion Criteria:

* Have any type of diabetes with hemoglobin A1c (HbA1c) level of 6.5 percent (%) or greater.
* Have significant history of or currently have Major Depressive Disorder or psychiatric disorder within the last 2 years.
* Obesity induced by other endocrine disorders, such as Cushing's syndrome or Prader-Willi syndrome.
* Have known clinically significant gastric emptying abnormality.
* Have undergone bariatric surgery (for example: Lap-Band, Gastric Bypass)
* Have a known self or family history (first-degree relative) of multiple endocrine neoplasia type 2A or type 2B, thyroid C-cell hyperplasia, or any form of thyroid cancer.
* Have an abnormal 12-lead electrocardiogram (ECG) at screening.
* Have significant previous or current history of comorbidities capable of significantly altering the absorption, metabolism, or elimination of drug.
* Participants must not be currently participating in or completed a clinical trial within the last 90 days.
* Have a known allergy or hypersensitivity to midazolam, simvastatin, rosuvastatin, or digoxin.
Chronic Hypertension and Pregnancy 2 (CHAP2) Pilot Project

The CHAP2 study is designed to provide preliminary data for a larger multicenter study to assess whether treatment of stage 1 hypertension (HTN) in pregnancy improves maternal and or neonatal outcomes. The primary objective of this pilot study is to determine if anti-HTN treatment to BP\<130/80mmHg in pregnant patients with stage 1 HTN is associated with a difference in birthweight percentile at delivery. Patients with stage 1 hypertension in pregnancy will be randomized to BP goals of \<130/80mmHg or usual care to treatment only if BPs ≥140/90mmHg. For this pilot, the investigator will randomize a total of 74 eligible participants, 37 to active treatment to BP\<130/80mmHg and 37 to usual care.


Eligibility Criteria:
Inclusion Criteria:

* Viable singleton gestation
* No fetal anomalies
* Blood pressures 130-139/80-89mmHg on two occasions at least 4 hours apart prior to 20 weeks gestation
* Planning to deliver at UAB Hospital
* No indication for pregnancy termination
* Receiving care at the UAB prenatal clinics

Exclusion Criteria:

* Declines Randomization
* Known diagnosis of chronic hypertension ( BP ≥ 140/90mmHg) or current antihypertensive medication use
* Fetal demise diagnosed prior to enrollment
* Known major structural of chromosomal abnormalities prior to enrollment
* Contraindication to first line antihypertensive (Nifedipine/ Labetalol)
* Comorbidities requiring BP goals \< 130/80mmHg
Presence of Minor Anti Phospholipid Antibodies in Blood Samples of Ischemic Stroke Patients and Healthy Controls

The investigators expect to find higher levels of both classical and minor antiphospholipid (APL) antibodies among the stroke cases. Furthermore, the investigators expect to find not only classical APLA but also minor antibodies.

The investigators believe that minor antibodies have a major role in the hypercoagulability state.


Eligibility Criteria:
Inclusion Criteria:

* stroke diagnosis
* blood sampling within 36hrs from the event
* written agreement

Exclusion Criteria:

* a stroke, MI or major operation prior to the current stroke
* hypercoagulable state known in this patient
* a severe chronic disease known at the time of the stroke
* an infection on arrival (based on anamnesis, physical exam and lab tests)
* thrombolytic treatment
Retrospective Epidemiological Study of Locally Advanced Non Small Cell Lung Cancer Patients in Brazil

RELANCE is a large multi-institutional study that aims to retrospectively collect information about diagnostic, treatment and outcome of patients diagnosed with locally advanced NSCLC in Brazil. It is hypothesized that there is a great heterogeneity in treatment patterns owing to inequities in access to adequate staging methods, optimal treatment and multidisciplinary teams in Brazil.

RELANCE study will collect sociodemographic and clinical data of patients diagnosed with locally advanced NSCLC in the period of January 2015 and Jun 2019 in the participating institutions. Socio-demographic characteristics, clinicopathological features, treatments patterns and outcomes will be recovered from medical charts. Disease status and survival data will be collected up to the last date of follow-up June 2021.

Eligibility Criteria:
Inclusion Criteria:

1. Patients aged 18 years or older;
2. Histologically or cytological diagnosis of NSCLC in the period of January 2015 to December 2016;
3. Locally Advanced NSCLC defined as clinical stage IIIA and IIIB according to 7th Edition TNM Staging System;
4. Any NSCLC histological subtype and molecular mutation;
5. Any Eastern Cooperative Oncology Group (ECOG) Performance Status (0 to 4) at diagnosis;
6. Patients assigned by treating physician to any therapy or palliative care;
7. Access to patient medical chart for data collection.

Exclusion Criteria:

1. Small cell lung cancer and non-invasive NSCLC;
2. Synchronic NSCLC or second primary tumour in the last 5 years (except non-melanoma skin cancer).
Selenium in the Prevention of Cancer

This is a pilot study proceeding an intended international trial.

Hypothesis: Daily intake of selenium supplementation in the form of selenium-enriched yeast tablets will reduce the risk of cancer in healthy individuals.

Objective: The objective of this pilot study was to assess the viability of a full scale randomised trial.

AMENDMENT TO STUDY OBJECTIVE: Mortality analysis during intervention and follow-up as specified in the sections concerning study design and outcome measures.


Eligibility Criteria:
Inclusion Criteria:

* WHO performance status 0 or 1
* No active liver- or kidney disease (Serum ALAT (alanine aminotransferase), alkalic phosphatase, bilirubin, creatinin or urea within 2 S.D of laboratory reference range)
* No previous cancer diagnosis
* No known HIV-infection
* Participant must understand oral and written information
* Participant must not use selenium supplementation of above 50 mcg/d
* Participant must give written consent prior to inclusion
Improving the Mobility of Transportation Disadvantaged Older Adults

The primary objective of the research was to improve mobility for transportation-disadvantaged older adults by expanding the scope of the existing Healthy Buddy Program, to accommodate an aging Spanish-speaking population in the U.S.

The research identified barriers and opportunities to improve Hispanic/Latino older adult access to community-based transportation and health resources. It was conducted with the existing Healthy Buddy model, which pairs older adults with college students who are trained to help them identify relevant transportation and health resources, while accommodating the unique needs of this transportation-disadvantaged population. The research team reevaluated the potential effectiveness of a Spanish-language accessible Healthy Buddy program model for increasing the self-efficacy and quality of life among Hispanic/Latino older adults. The team recruited bilingual (English-Spanish-speaking) students from multidisciplinary backgrounds. Older adult participants were invited to participate in pre- and post-surveys, including a qualitative interview, to allow the team to further evaluate the success of the program among Hispanic/Latino participants and to determine the replicability of the project in other communities with a significant population of transportation disadvantaged Hispanic/Latino older adults.

Eligibility Criteria:
Inclusion Criteria:

* Older adults age 65+
* Those who no longer drive
* Resident of Texas
* Those who manage at least one health condition (e.g., diabetes, high blood pressure, etc.)
* Spanish is primary language

Exclusion Criteria:

* Those who do not have a capacity to answer the pre-screening questions due to their cognitive and physical limitations
* Hispanic individuals who can speak fluent English will be excluded because they may have a better understanding of existing resources and information written and serviced in English in the community.
Impact of Follicular and Blood G-CSF During a Natural Cycle of IVF

Recently, scientists look into G-CSF (Granulocyte - Colony Stimulatin Factor). The use of this molecule is increasing in reproduction pathology. High level of follicular and blood G-CSF on the day of oocyte retrieval could correlate with higher pregnancy and implantation rates.


Eligibility Criteria:
Inclusion Criteria:

* Women between 18 and 43 years old
* Women natural In Vitro Fecondation

Exclusion Criteria:

* No exclusion criteria
Pilot Trial to Elaborate a Cutaneous Antigen Neutralization Test in Patients Suffering From Rhinoconjunctivitis

To find a test to elaborate a parameter for specific immunotherapy in allergic patients


Eligibility Criteria:
Inclusion Criteria:

* Age between 18 and 65
* Signed informed consent
* SIT 2000/2001
* 10 patients with SIT with a good result- 10 patients with bad results

Exclusion criteria:

* Pregnancy and breastfeeding
7-week Study With CT-155 in People With Schizophrenia

CT-155 is a novel prescription digital therapeutic (PDT) to treat schizophrenia

CT-155 is a novel prescription digital therapeutic (PDT) being developed by Click Therapeutics, Inc. (Click) and Boehringer Ingelheim (BI) using an interactive, software-based intervention to treat schizophrenia.

This is a multi-center, exploratory, single-arm study to evaluate the feasibility and acceptability of treatment with an abbreviated version of CT-155 in adults diagnosed with schizophrenia. Eligible participants must have a diagnosis of schizophrenia per the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5).

Participants that meet eligibility criteria will be enrolled in the study on Day 1. The study consists of an up to 7-day screening period, a 49-day engagement period, and an up to 7-day follow-up period.

Eligibility Criteria:
Inclusion Criteria:

1. Has outpatient treatment status of schizophrenia.
2. Is on a stable dose of antipsychotic medication(s)
3. Is the solo user of an iPhone with iPhone operating system (iOS)13 or greater capabilities or a smart phone with an Android operating system (OS) 9 or greater capabilities.
4. Is the owner of, and has regular access to, an email address.
5. Has regular access to the internet via cellular data plan and/or wifi.
6. Willing and able to receive SMS text messages on their smartphone and email messages, and understand how to use the downloaded Study App.
7. Has stable housing and has remained at the same residence for at least 12 weeks prior to screening, with no anticipated housing changes during the duration of the study

Exclusion Criteria:

1. Is currently treated with more than two antipsychotic medications.
2. Is currently treated with clozapine or haloperidol.
3. Has active prominent positive symptoms to preclude effective engagement in treatment for negative symptoms.
4. Is currently receiving or has received psychotherapy within 12 weeks prior to screening.
5. Meets either the International Classification of Diseases (ICD-10) or DSM-5 criteria for diagnoses not under investigation.
6. Has post-traumatic stress disorder (PTSD), bipolar disorder, major depressive disorder, developmental disorders, or any prominent disorder.
7. Has substance or alcohol use disorder.
8. Currently needs or will likely require prohibited concomitant medications.
9. Is currently participating in another clinical study.
10. Prior participation in the CT-155-C-001 clinical study.
11. Has suicidal ideation or behavior.
Vitamin E and Infection in the Elderly

Aging is associated with a variety of changes in the immune system. These changes result in a less effective immune response, which places the elderly at a greater risk for infection and disease. Respiratory infections cause a great number of morbidity and mortality in the elderly population. Vitamin E has been known to improve the immune response of the elderly and has been suggested for use in preventative strategies for this population. The purpose of this study is to examine the effect of one year vitamin supplementation on respiratory infection in the elderly population residing in nursing homes. This study was conducted using a randomized, double blind, placebo controlled clinical trial at 33 long-term care facilities in the greater Boston area. A total of 617 subjects over the age of 65 were enrolled in the study, with 451 completers. The participants were supplemented wit either 200 IU of vitamin E per day or placebo. The primary outcomes consisted of respiratory tract infection, number of sick days, and antibiotic use. The study involved use of questionnaires, standard anthropometrics measurements, non-invasive body composition, blood and urine sample collection, and delayed type test (DTH) using the Mantoux method. This study has been closed since August 2000 and is in the stage of data analysis only.


Eligibility Criteria:
Inclusion Criteria:

* aged 65 years or older;
* life expectancy greater than 6 months;
* no anticipated discharge within 3 months;
* not room-bound for the past 3 months;
* absence of active neoplastic disease;
* no tube feeding, no kidney dialysis;
* no intravenous or urethral catheters for the last 30 days;
* no tracheostomy or chronic ventilator;
* antibiotic-free for more than 2 weeks;
* no long-term steroid treatment greater than 10 mg/d, no use of immunosuppressive drugs, or greater than the recommended daily allowance (RDA) level of supplements of vitamins E, C, or B6, selenium, zinc, beta-carotene, or fish oil;
* body mass index of at least 18;
* serum albumin at least 3.0 g/dL; able to swallow pills;
* willing to receive influenza vaccine;
* willing to provide informed consent (for patients with dementia, family members provided informed consent)

Exclusion Criteria: