cyrilzakka/clinical-trials huggingface dataset:
Non-invasive Measurement of Hemoglobin in Retinal Arteries

The purpose of this study is to test a new non-invasive tool to measure hemoglobin in retinal arteries.

To our knowledge no tool exists that allows for direct collection of hemoglobin data in the eye. In many eye diseases (especially diabetic and hypertensive retinopathy as well as in retinal vessel occlusions) retinal circulation is modified. Knowing hemoglobin concentration on the site of the pathology will give us further information about the pathogenesis of this diseases and may provide a new possibility in therapy.

The purpose of this study is to test a new non-invasive tool to measure hemoglobin in retinal arteries. Healthy volunteers from the eye clinic and pregnant otherwise healthy patients of the gynecological department of the Triemli Hospital, Zurich, as well as anemic gynecological patients that show up for a check-up are included.

Hemoglobin will be quantified by a blood draw of a cubital vein. Using a Fundus Camera (Nidek AFC-230) pictures of the fundus will be taken from each study patient. Afterwards the study investigator selects a retinal artery of interest which will be used for measuring the hemoglobin concentration. Intensity of the green channel of the camera chip is determined with the aid of the law of Lambert-Beer.

Absolute Hemoglobin concentration is calculated in relation to the vessel volume.

Eligibility Criteria:
Inclusion Criteria:

* healthy volunteers
* pregnant patients from the Triemli Hospital that came for a routine check up
* anemic patients of the same dept with various gynecological tumors

Exclusion Criteria:

* any known retinal eye disease
* poor fundus picture quality due to fixtion problems or too small pupil or media intransparency
* not willing to participate in a study
Evaluation of the Hypnotic Properties of Zolpidem-MR 12.5 mg and Zolpidem 10 mg Marketed Product Compared to Placebo in Patients With Primary Insomnia

The primary objective is to evaluate the hypnotic efficacy of zolpidem-MR (modified release) 12.5 mg and zolpidem 10 mg marketed product in comparison with placebo in patients with primary insomnia and sleep maintenance difficulties, using polysomnography (PSG) recordings and patient sleep questionnaires.

The secondary objective is to evaluate the clinical safety and tolerability of zolpidem-MR 12.5 mg and zolpidem 10 mg marketed product in comparison with placebo.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of primary insomnia based on Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) criteria
Collection of Blood for Multiple Collaborative Studies

This study seeks to confidentially collect blood from HIV-positive individuals and HIV-negative controls to provide basic scientists with specimens for collaborative studies.

HIV positive patients are currently the focus of multiple collaborative research studies, both at UCSF and other institutions. The aims of these research projects include improving the understanding of etiology, immunology, epidemiology and treatment of HIV. There are numerous requests from basic scientists at UCSF for collaborative studies on specimens, especially for blood, saliva and urine samples. Specimens may be used to test such things as virus characteristics, genotyping and/or phenotyping resistance, plasma drug concentrations, immune function or evidence of complications of HIV disease. The samples may also be tested for genetic factors that may be related to the course of HIV disease

Eligibility Criteria:
Inclusion Criteria:

* HIV-1 antibody negative with similar characteristics to HIV-1 positive cohort
* HIV-positive subjects naive to antiretroviral therapy
* HIV-positive subjects stable on or off antiretroviral therapy for a minimum of 6 months
* Good venous access
* Able to provide informed consent

Exclusion Criteria:

* Hemoglobin \< 9g/dl
* Hematocrit \< 27%
* Active treatment for cancer
* Hospitalization or IV antibiotic use within the last 4 months
* Immunosuppressive therapy within the last 4 months
The Effects of Dragon Fruit Consumption on Vascular Function.

Native to South America and South East Asia, the dragon fruit (pitaya) has become increasingly popular world-wide due to their vivid hue and bizarre structure. More importantly, their high levels of bioactive phytochemical betalains has sparked considerable scientific interest. Recent findings from in vitro and in vivo animal studies tentatively suggest that betalains may have ameliorative effects on vascular function. This will be a first randomised controlled trial aimed to explore the impact of dragon fruit consumption on blood pressure and other vascular parameters in healthy individuals. The study will feature a randomised, double-blinded, placebo-controlled and crossover design with flow-mediated dilatation (FMD) as primary outcome along with blood pressure and arterial stiffness as secondary outcomes. Cardiovascular biomarkers as well as relevant metabolites will also be determined from blood and urine samples collected from participants.


Eligibility Criteria:
Inclusion Criteria:

1. Healthy men and women aged 18-40 years old
2. Subjects are willing to maintain their normal eating/drinking habits and exercise habits to avoid changes in body.

   weight over the duration of the study.
3. Are able to understand the nature of the study.
4. Able to give signed written informed consent.
5. Signed informed consent form.

Exclusion Criteria:

1. Medical history of cardiovascular disease including coronary artery disease, cerebrovascular disease and peripheral artery disease.
2. Hypertensive, as defined as SBP superior or equal to 140 mmHg.
3. Obese participants, defined as BMI superior or equal to 30.
4. Medical history of diabetes mellitus, metabolic syndrome, terminal renal failure or malignancies.
5. Abnormal heart rhythm (lower or higher than 60-100 bpm).
6. Allergies to dragon fruit, cactus pear or other significant food allergy.
7. Subjects under medication that can affect the cardiovascular system or on vitamin/dietary supplements.
8. Subjects who have lost more than 10% of their weight in the past 6 months or are currently in a diet
9. Subjects who reported participant in another study within one month before the study start.
10. Subjects who smokes.
11. Pregnant women or planning to become pregnant in the next 6 months.
12. Any reason or condition that in the judgment of the clinical investigator(s) may put the subject at unacceptable risk or that may preclude the subject from understanding or complying with the study's requirements.
Micro-Ultrasound/Magnetic Resonance Imaging 001

Micro-ultrasound is a novel real-time imaging modality which maintains the clinical workflow of conventional ultrasound-guided prostate biopsy, while potentially maintaining a similar ability to detect clinically significant prostate cancer (csPCa) to MRI. This prospective trial aims to compare micro-ultrasound to mpMRI in detection of csPCa in the biopsy naïve.

Evidence from a large randomized clinical trial (clinical trials.gov ID NCT02079025), suggests that micro-ultrasound system is more sensitive than conventional transrectal-ultrasound (TRUS) to detect prostate cancer (PCa). the PRI-MUS (prostate risk identification using micro-ultrasound) scoring system was developed and validated to assess the risk of prostate cancer for targeted biopsy with the micro-ultrasound platform, similar to the PIRADS scoring system for suspicious areas on mpMRI. This project will compare micro-ultrasound imaging modality to the current gold-standard imaging for prostate cancer, mpMRI. By applying both modalities to the same patients, the investigators will provide a direct comparison of their screening abilities in terms of sensitivity, specificity, negative predictive value and positive predictive value. It will build evidence to demonstrate that micro-ultrasound may replace MRI/Fusion biopsy in these patients.This project aims to demonstrate that the micro-ultrasound 1) provides more sensitive initial biopsy, reducing the need for repeated procedures, thus lowering the rate of severe sepsis and the number of cancers found after local or regional progression, and 2) reduces the need for mpMRI following initial biopsy.

Eligibility Criteria:
Inclusion Criteria:

* Men with indication for a prostate biopsy will be offered inclusion in the study. Indications for biopsy include clinical suspicion of prostate cancer due to elevated PSA or abnormal digital rectal exam (DRE)

Exclusion Criteria:

* Patients with history of prostate cancer
* Patients with prior prostate biopsies
* Patients who are unwilling or unable to give informed consent
* Patients with contraindication to MRI (i.e. pacemaker, hip prosthesis, severe claustrophobia, brain aneurysm clip, allergy to MRI contrast agent)
Stress, Environment, and Genetics in Urban Children With Asthma

The purpose of this study is to evaluate the multiple mechanisms through which stress, physical environment, and genetic predisposition contribute to asthma in urban children.

BACKGROUND:

The study design builds on the ACCESS Study, a prospective pregnancy cohort study begun in 2003 of a cohort from birth to age four. The present study includes two new aims regarding the interaction of stress and genetic or environmental variables, reflecting a more comprehensive conceptualization of the multiple mechanisms by which stress can contribute to asthma. In addition, the current study proposes to follow the cohort until the age of three.

DESIGN NARRATIVE:

The study examines the role of psychosocial stressors in a systems biology framework considering multiple biologic pathways by which stress can contribute to asthma. The investigators will not only study the independent effect of stress on asthma/wheeze phenotypes in early childhood but also will consider stress as a modifier of physical environmental factors (allergens, cigarette smoking, and diesel-related air pollutants) and genetic predisposition on asthma risk. They will determine the independent effect of maternal stress (both prenatal and postnatal) on early childhood asthma phenotypes. They further hypothesize that multi-life stressors prevalent in disadvantaged populations can cumulatively influence immune system development and airway inflammation in early life, thus making the populations more susceptible to other environmental factors and genetic risk factors explaining, in part, observed asthma disparities associated with SES and race/ethnicity. They will take a multi-level approach, measuring both individual-level stress (negative life events, perceived stress, pregnancy anxiety) and community-level stress \[neighborhood disadvantage (e.g., percent of subjects living in poverty, percent unemployed), diminished social capital, and high crime/violence rates\]. They will also assess the influence of stress on the infant hormonal stress response and on T-helper cell differentiation as reflected in cytokine profiles and IgE expression (a topic or pro inflammatory phenotype). Additional physical environmental (indoor allergens, diesel-related air pollutants, tobacco smoke) and genetic factors will be assessed given their influence on the immune response and expression of early childhood asthma/wheeze. This interdisciplinary approach is unique because researchers are considering the context in which physical exposures and host susceptibility occur, analyzing their multiplicative joint effects and considering multiple biologic pathways, as such it is consistent with the NIH roadmap objectives.

Eligibility Criteria:
Inclusion criteria:

Mothers aged 18 years or more at time of enrollment and speak English or Spanish.

Exclusion criteria: None
Dementia Care Partner Hospital Assessment Tool

The purpose of this study is to see whether an adapted questionnaire called the Care Partner Hospital Assessment Tool (CHAT) for care partners of hospitalized patients living with Alzheimer's disease and related dementias (ADRD) (CHAT-AD) can help people with dementia receive better care after they go home from the hospital. Participants will be a care partner ('family member or friend') who provides unpaid care to a hospitalized adult relative or partner to help them take care of themselves because of dementia. Participants can expect to be in this study for 14 days.

The purpose of this study is to adapt CHAT for care partners of hospitalized patients living with ADRD (CHAT-AD) and evaluate its feasibility and potential efficacy in a pilot randomized clinical trial. Findings from this study will enable the lead researcher to launch an independent program of research that aims to (1) improve hospital-based care processes and outcomes for patients living with ADRD and their care partners, and (2) make clear the essential caregiving role that so many care partners of patients living with ADRD assume.

In order to adapt CHAT, there will be two design teams with key stakeholders from local aging networks and a large academic medical system: one team comprised of previously hospitalized patients living with ADRD and their care partners (N=7 dyads) and the second comprised of healthcare system administrators and clinicians (N=7). The team will use a validated participatory human-centered design process in which each team completes 5 co-design videoconference sessions that occur in parallel across 4 months, with 2-3 weeks between each session.

Upon adaptation of the CHAT-AD, the study team will partner with a medical and surgical units that are part of a large academic medical system to recruit 128 eligible care partners of hospitalized patients living with ADRD, randomized into either the CHAT-AD plus usual care or usual care-only groups. The team will assess feasibility by examining overall recruitment, attrition, safety, adherence, and implementation satisfaction. To examine efficacy, a validated measure of caregiving preparedness will be obtained pre- and post-intervention.

Eligibility Criteria:
Inclusion Criteria:

* Provide unpaid care to a hospitalized adult relative or partner to help them take care of themselves because of ADRD
* 18 years or older

Exclusion Criteria:

* Non-English speaking
Research Study of Greater Occipital Nerve Block As A Treatment For Prolonged Migraine Attacks

Greater Occipital Nerve Blocks (GONB) are a common procedure used for the treatment of headache. The GONB procedure involves a series of injections into the greater occipital nerve (a spinal nerve located at the back of your head). The purpose of this study is to determine whether GONB is effective for the treatment of prolonged migraine attacks. This study is placebo controlled, which means that half of the patients participating will receive injections of active study drug (lidocaine plus bupivicaine) and half of the patients will receive injections of saline (placebo). The study is also blinded which means that neither you nor the study staff will know whether you received active study drug or placebo. The study remains blinded only for the first 30 minutes, at which point additional treatments (including GONB) can be administered at the discretion of your treating physician.

40 patients are expected to participate in this research study. This study is being conducted at Thomas Jefferson University only.


Eligibility Criteria:
Inclusion Criteria:

* Subjects, male or female, between the ages of 18 and 80 years old (inclusive) with a previous diagnosis fulfilling IHS criteria for episodic migraine
* Presenting to clinic in migraine status, meaning the migraine has continued for greater than or equal to 3 days but less than 3 months.
* Pain must be reported as at least moderate pain level at time of injections

Exclusion Criteria:

A subject is ineligible to participate in this study if he/she satisfies any of the following criteria:

* Subjects who have received greater occipital nerve blocks in the past
* Subjects who in their own or the investigator's opinion are unable to describe their symptoms
* Subjects who are pregnant or lactating
A Study Comparing the Safety and Efficacy of Ziprasidone and Risperidone for the Treatment of Chronic Schizophrenia

The purpose of this study is to compare the safety of ziprasidone and risperidone for the treatment of chronic schizophrenia. The primary purpose is to differentiate the effects of ziprasidone and risperidone on extrapyramidal side effects and the secondary purpose is to compare their tolerability and efficacy.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of schizophrenia
* CGI-S score of 4 or less at baseline

Exclusion Criteria:

* Concurrent antipsychotic treatment
* Treatment with antidepressants or mood stabilizers within 2 weeks of randomization
* Acute exacerbation of schizophrenia within 3 months of baseline
FMT in Pediatric Crohn's Disease

The goal of this study is to evaluate the safety of Fecal Microbiota Transplantation (FMT) in children with Crohn's disease who are in remission. Safety will be the primary endpoint and Pediatric Crohn's Disease. Pediatric Crohn's Disease Activity Index (PCDAI) with other secondary endpoints including changes in gut microbial diversity will also be studied. All children will receive the equivalent of 50g of stools from a healthy donor into the jejunum through upper endoscopy. Also, 1-2 additional mucosal biopsies will be collected during patient's routine (standard of care) endoscopy. Subjects will have a total of 5 study visits within 24 weeks including phone call follow up on Day 7 after FMT.

The Investigators hypothesize that children with Crohn's disease who are in remission can receive a single endoscopic dose of FMT with no significant safety concerns.

All children will receive the equivalent of 50 g of stools from a healthy donor into the jejunum through upper endoscopy. Children will be seen at baseline, then 4 and 24 weeks after study drug administration begins. Stools will be collected and stored for gut microbial profiles during the study visit windows. In addition, a follow up telephone call will be performed 7 days after study drug is administered. If children undergo endoscopy as part of the standard of care, study staff will obtain 1-2 additional biopsies for evaluation of mucosal inflammation. This study will also capture any laboratory results if any of the subjects undergo laboratory testing as part of the standard of care. This study will define the effects of transplant on gut microbial profile using advanced molecular taxonomic approaches. Safety will be closely monitored by solicited (during defined telephone calls and study visits) and unsolicited adverse events (at all times). Safety will be the primary endpoint of this study. Secondary endpoints include Pediatric Crohn's Disease Activity Index (PCDAI), changes in gut microbial diversity - determined by gut microbial genomics and proteomics (16S ribosomal RNA, 16s rRNA), and outcome measures for mucosal inflammation and repair as reflected through laboratory testing such as the level for C-reactive protein (CRP), erythrocyte sedimentation rate (ESR), inflammatory cytokines of the colonic mucosa as well as the stool calprotectin level.

Eligibility Criteria:
Inclusion Criteria:

1. Age: 7-21 who have been diagnosed with Crohn's disease
2. Remission of disease defined as PCDAI \<10
3. Needs upper GI endoscopy

Exclusion Criteria:

1. Unwilling to give informed consent/assent
2. Pregnancy and breast feeding in patient subjects of childbearing potential
3. Subjects with significant renal and liver dysfunction (creatinine \> 2 mg/dl and direct bilirubin \> 2 mg/dl)
4. Subjects with congenital or acquired immunodeficiency, or who are immunosuppressed due to conditions other than Crohn's disease (such as neoplastic disease or organ transplantation), have received or are receiving chemotherapy, or have been diagnosed with HIV.
5. Subjects with severe food allergies
Evaluation of Strong & Steady - Fall Preventive Group Exercise Program

The aim of the study is to investigate the effect of Strong and Steady (S\&S) group exercise on fall risk and physical function among community-dwelling older adults over 12 months. A pre-post test study deign will be used.

The S\&S group exercise program builds on the Otago and FaME exercise programs which have shown to be effective in preventing falls. Strong and steady has been adapted to more functionally fit older people.

The study period will be one year. Due to the corona pandemic all S\&S groups in Norway have been closed. Due to this all participants have had a break from their exercise program for more than 6 months and can be seen av new participants to the exercise groups. Participants that are about to start in a S\&S group in municipalities in Trøndelag will be asked to participate in this study. They will go through tests of muscle strength and balance in addition to questionnaires at baseline and after 6 and 12 months of exercise. Where possible the participants will go through the same tests 1 month before they start to exercise in addition to the three other test timepoints.

Eligibility Criteria:
Inclusion Criteria:

* Able to get to the training facilities on their own
* Able to walk without a walking aid indoors

Exclusion Criteria:

* Diagnosed with dementia
Zanubrutinib, Obinutuzumab and Lenalidomide (ZGR) in High-risk Treatment-naive Patients with Follicular Lymphoma (FL)

This is a prospective, multiple-centers, open-label, single-arm clinical study designed to evaluate the efficacy and safety of Zanubrutinib, Obinutuzumab, and Lenalidomide (ZGR) in high-risk treatment-naive patients with follicular lymphomas


Eligibility Criteria:
Inclusion Criteria:

1. Pathologically confirmed CD20 positive follicular lymphoma grade 1, 2, or 3A based on 2016 WHO classification
2. Treatment naive
3. Age ≥ 18 years
4. Indications for treatment confirmed
5. Identified as high-risk group by Follicular Lymphoma International Prognostic Index 2 (FLIPI2) at enrollment
6. Must has measurable lesion in CT or PET-CT prior to treatment
7. Considered suitable for ZGR regimens
8. Informed consented

Exclusion Criteria:

* Transformed follicular lymphoma or 3B follicular lymphoma;
* HBsAg positive and / or HBcAb positive with HBV DNA titer; HCV antibody positive with HCV-RNA; or HIV positive
* Any drug contraindication in the treatment plan
* Pregnant or lactating women
* Patients judged by other researchers to be unsuitable for inclusion in the study
Effects Of Plyometric Training Program On Speed And Agility In Young Cricketers

This study was to determine the effects of plyometric training program on speed and agility in young cricketer. There were two groups, one received plyometric training program and other received training training to improve speed and agility in young cricketers

Plyometric training has been an effective method for the improvement of agility, sprinting, and jumping ability and it has also been reported to Improve running economy, joint stability, increased joint awareness and overall proprioception and decrease the severity of knee injuries. In the Plyometric exercise involves starting, stopping, and change of movement directions which contribute to agility development.The athletes use plyometric training techniques in many sports to improve explosive power and body strength. The plyometrics is a rapid stretch of muscle (eccentric) contraction straight away shortening (concentric) contraction in similar muscle tissue

Eligibility Criteria:
Inclusion Criteria:

°The male professional cricketers with age between 14-24 years old from Islamabad were included.

Exclusion Criteria:

° Cricketers not engaged in game from last 1 month.