cyrilzakka/clinical-trials huggingface dataset:
Functional Brain Imaging - Acupuncture and Osteoarthritis

The goal of this study is to use single photon emission computed tomography (SPECT) and functional magnetic resonance imaging (f-MRI) of the brain to study the response of both normal participants and participants with Osteoarthritis (OA) of the knee to acupuncture.

Recent experimental studies in both animal and humans have begun to demonstrate some measurable physiologic effects that are associated with acupuncture, suggesting the possibility of a neurophysiologic explanation. In addition, brain research continues to uncover a complex set of endogenous neurologic control systems, such that it has become clear that the brain plays a major role in the modulation of pain perception and control. If acupuncture can be demonstrated to have a consistent effect on specific areas of the brain, it will become possible to explore the potential efficacy of acupuncture based on measurable neurophysiologic responses.

Eligibility Criteria:
Inclusion criteria:

* Seen in an outpatient clinical setting
* Have active knee OA of \>6 months including Kellgren x-ray changes \>2 from an x-ray report \<12 months old or new x-ray interpretation
* Moderate unilateral only pain (average \>4/10 on a 0-10 likert scale) for more than 5 out of 7 days
* Have the capacity to understand the requirements of the study and complete the baseline studies in a reasonable time frame, as determined by the interviewer

Exclusion criteria:

* Having had acupuncture before (must be acupuncture naïve)
* Any history of claustrophobia that could affect the subject's ability to tolerate the f-MRI study
* Hip or ankle disease by history or exam severe enough to cause pain \>2/10 daily
* Bleeding disorder or current use of warfarin or heparin by patient history
* Other primary causes of chronic knee pain, per the referring physician, including chondromalacia patella, torn meniscus or ligament injury.
A Study to Measure the Amount of Evacetrapib That Enters the Blood Stream in Healthy Participants

Evacetrapib (study drug) is an investigational drug being developed with the aim to help people at high risk of heart problems in the future.

In this study we will be comparing how much of the study drug gets into the blood stream when it is given as a single dose (in tablet form) compared to an intravenous injection (given directly into a vein via a small needle).

The study is expected to last at least 15 days for each participant, not including screening. Screening will occur up to 28 days before the study drug is given.


Eligibility Criteria:
Inclusion Criteria:

* Are overtly healthy males or females, as determined by medical history and physical examination
* Female participants are post menopausal women or women not of child bearing potential due to surgical sterilization (at least 6 weeks after surgical hysterectomy, bilateral oophorectomy, or tubal occlusion) confirmed by medical history, or menopause
* Have a body mass index (BMI) of less than 32 kilograms per square meter (kg/m\^2)
* Have given written informed consent approved by Eli Lilly and Company and the ethical review board (ERB) governing the site

Exclusion Criteria:

* Have known allergies to evacetrapib, related compounds or any components of the formulation, intolerance to alcohol containing products, or history of significant allergic disease as determined by the investigator
* Have an abnormal blood pressure as determined by the investigator
* Have a history or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; of constituting a risk when taking the study medication; or of interfering with the interpretation of data
* Regularly use known drugs of abuse and/or show positive findings on urinary drug screening
* Show evidence of human immunodeficiency virus (HIV) infection and/or positive human HIV antibodies
* Are women who are pregnant or are lactating
* Have used or intend to use over-the-counter or prescription medications (including vitamins/mineral supplements/herbal medicine) 14 days prior to the first dose and during the study. The use of topical medicine, provided there is no evidence of chronic dosing with risk of systemic exposure, and occasional acetaminophen is acceptable
* Have donated blood of more than 500 milliliter (mL) within the last 3 months
* Are unwilling to comply with the dietary requirements/restrictions during the study:

  * Consume only the meals provided during the inpatient appointments,
  * Refrain from eating any food or drinking any beverages containing grapefruit, grapefruit juice, Seville oranges, Seville orange juice, star fruit, pomelo, or commercial apple juice or orange juice for at least 7 days prior to the first dose
"Juego de LLaves": Study Protocol of a Universal School-based Drug Use Prevention Program (PSIDUP)

"Juego de Llaves" is a universal school-based drug prevention program for adolescents aged 12-15 years. The outcome evaluation is critical to determine the quality of preventive interventions. This protocol describes the full protocol of the evaluation design, instruments, randomization procedure, follow-ups, and primary outcomes. Method: Non-Randomized Control Cluster Trial in a set of Spanish school centers at the compulsory secondary education level, with follow-ups at 12-, 24- and 36-months. Participants will be allocated to an experimental or control (no intervention) group. Using an electronic ad-hoc designed App, a battery of instruments will be used to assess addictive behaviors, sociodemographic variables, school climate and other transdiagnostic psychological variables. A piloting test will be conducted to test the implementation protocol and to calculate the sample size needed for the outcome evaluation. After implementing the program, longitudinal statistical approaches will be used to inform on the intervention efficacy and potential moderators and mediators. There is a lack of effectiveness assessments of school prevention programs, and it is expected that this protocol will expedite the monitoring and ongoing evaluation in prevention.


Eligibility Criteria:
Inclusion Criteria:

* Schools having secondary education.
* Schools located in Spain.
* Schools willing to participate under the conditions of the study before randomization.

Exclusion Criteria:

* Schools having other interventions with a strong package on substance use prevention targeted the same grades.
A Study Of the Effectiveness Of Pomegranate Pills in Men With Prostate Cancer Before Prostatectomy

The purpose of this study is to compare the effects of pomegranate polyphenol pills (POM-X) and a placebo (sugar pill) on prostatic oxidative stress. The placebo is a pill that looks like the POM-X pill but does not have an active ingredient.

Subjects will receive POM-X or placebo pills daily for up to 4 weeks prior to undergoing radical prostatectomy for prostate cancer. Biomarkers in the blood, urine, and prostate tissue will be assessed.

Eligibility Criteria:
Inclusion Criteria:

1. Histologically confirmed adenocarcinoma of the prostate, without evidence of spread beyond to lymph nodes, bone, or visceral organs.
2. Radical prostatectomy scheduled at Duke or Johns Hopkins.
3. Initial prostate biopsy available for review with tumor involving 2 or more core biopsies based on pathologic review.
4. Age ≥ 18 years of age.
5. Willingness and ability to sign an informed consent document.
6. Agreement with complete abstinence from other commercially available pomegranate products during the course of the study.
7. No prior allergy to pomegranate dietary agents.
8. No significant medical or psychiatric condition that would make the patient a poor protocol candidate.
9. The patient agrees to stop taking dietary or vitamin supplements (lycopene, vitamin E, selenium, genistein) or herbal supplements (eg. saw palmetto) for 2-weeks prior to staring the study.
10. The patient is not taking LHRH agonists, androgen receptor blocking agents or finasteride, and has not undergone bilateral orchiectomy.
11. Patient has not received experimental medications within the past six months.

Exclusion Criteria:

1. Significant concomitant medical or psychiatric condition that, in the opinion of the investigator, would make the participant a poor protocol candidate.
2. Concomitant or antecedent hormonal therapy.
3. Known allergy to pomegranate juice.
4. Subjects unable or unwilling to comply with protocol requirements.
5. Evidence of metastatic disease on physical examination or on CT or bone scan.
6. Use of finasteride, dutasteride at any point during the study.
7. Clinically significant abnormal laboratory value \>2X the upper limit of normal (2XULN).
Efficacy of Metoclopramide in Poor Ovarian Response IVF Patients

Poor ovarian response population of ART are considered the biggest challenge for providers. Hitherto, no one protocol has been proven to be effect in this subgroup of IVF patients.

Metoclopramide belongs to the antiemetic group, used for motion sickness and during early gestation for hyperemesis gravidarum.

The mechanism of action is antagonisim to dopamine receptors. We hypothesize than by blocking dopamine receptors and decreasing the dopaminergic tone there is a possibility to increase the sensitivity of ovarian response to gonadotropins during controlled ovarian stimulation and result in increased oocyte retrival.


Eligibility Criteria:
Inclusion Criteria:

* Poor response according to "Bologna criteria"

Exclusion Criteria:

* Allergy to metoclopramide
* Prolactinemia
* Women treated with dopamine agonists
New Dosages of Inflammatory Markers for the Early Diagnosis of Nosocomial Bacterial Infections of the Newborn

This study aims to evaluate new dosage of inflammatory markers or new inflammatory markers for the diagnosis of nosocomial bacterial infection. We made the hypothesis that these new dosages or new inflammatory markers could be more useful than dosage of inflammatory markers already used in clinical practice (especially the use of a combination of interleukins (6 or 8) and C-reactive protein for the management of newborns with a clinical suspicion of nosocomial bacterial infection and especially could allow to avoid excessive treatment with antibiotics


Eligibility Criteria:
Inclusion Criteria:

* Newborns \> 72 hours of life hospitalized in neonatal intensive or intermediate care unit presenting a clinical suspicion of NBI

Exclusion Criteria:

* Early post-operative period ( surgery of less than 48 hours)
* Multiple malformations
* Newborn already included in the study for a previous septic events
* Newborn treated with antibiotics in the last 24 hours
Defining the Role of the Gut Microbiome in Mediating the Effects of Obesity on Intestinal Stem Cells

New studies are revealing how a high-fat diet could be making the cells of the intestinal lining more likely to become cancerous. The investigators would like to study how obesity influences growth of intestinal stem cells, which could then trigger intestinal tumors.

The investigators are proposing a Pilot Study of 20 subjects (comprised of 10 participants from each of two different BMI categories: 20-25 and 35 \& above), who will be asked to provide blood, stool, \& urine samples, undergo a flexible sigmoidoscopy, and complete food frequency questionnaires

Hypothesis:

The investigators will test the hypothesis that the gut microbiome drives many of the effects that a pro-obesity high-fat diet has on intestinal stem cell (ISC) biology, which includes 1) an increase in ISC numbers and proliferation, 2) a reduced dependency on niche cells for intestinal organoid initiation, or 3) the acquisition of organoid-initiation by non-stem cell population in the intestinal epithelium.

Specific Aims:

1. To determine whether differences in the gut microbiome in obese human subjects correlates with enhanced intestinal stem cell numbers and function.
2. To validate whether obesity-driven changes in the gut microbiome of human recapitulate the effects of obesity on intestinal stem cell function in germ-free mice.

Eligibility Criteria:
Subject and Control Inclusion Criteria

1. Participants have a Body Mass Index (BMI) between 20-25 or 35 and above.
2. Adults aged 18-65

Exclusion Criteria:

1. Known diagnosis of inflammatory bowel disease, microscopic colitis, celiac disease or other inflammatory conditions or diabetes mellitus
2. Antibiotic use within the past 4 weeks (they can be enrolled after a four week washout period and subsequent use during the 6 month study duration does not exclude them)
3. Bowel preparation for colonoscopy within the past week
4. Significant bowel surgery other than hysterectomy or appendectomy
5. Pregnancy or plans to become pregnant within the study time frame
6. Any other disease(s), condition(s) or habit(s) that would interfere with completion of study, or in the judgment of the investigator would potentially interfere with compliance to this study or would adversely affect study outcomes.
7. Age\<18 or vulnerable adults -
Open Label Continuation Study in Moderate to Severe Psoriasis

The purpose of this study is to evaluate long term safety, efficacy and tolerability of ABT-874 in adults with moderate to severe psoriasis.


Eligibility Criteria:
Inclusion Criteria:

* Having participated in a preceding ABT-874 clinical trial for ABT-874
* Subject has a clinical diagnosis of moderate to severe plaque psoriasis

Exclusion Criteria:

* Subjects who prematurely discontinued in any preceding psoriasis study with ABT-874 other than protocol-required discontinuation
Multi-frequency Bioelectrical Impedance for Estimating Total Body Water by Deuterium Dilution

SPECIFIC AIM:

Determine the validity of the Biospace bioelectrical impedance devices compared to deuterium water (D2O) measurements.

HYPOTHESIS:

The Biospace Body Composition Analyzers are valid tools for measuring total body water and body composition.


Eligibility Criteria:
Inclusion Criteria:

* men and women between 18-59 years of age

Exclusion Criteria:

* Acute illness (infection, recent surgery, trauma).
* pregnancy
* pacemaker or defibrillator
* We would like to standardize the procedures and measurements in the adult population first. Older adults are excluded because by including older adults at this time, we would need to increase the sample size because we believe older adults have greater fluctuations in hydration due to medications, diet, and co-morbidities.
Physical Activity, Knee Joint Loading and Joint Health

The purpose of this study is to investigate the association between time spent in moderate to vigorous physical activity and markers of cartilage metabolism in the years following anterior cruciate ligament reconstruction.

Participants attend the laboratory on two or three occasions and wear accelerometers for the 10 days in between the first and second laboratory session. The first laboratory session involves urine sample collection, the completion of questionnaires, blood sample collection, acquisition of cross-sectional images of the thigh and calf, and a whole-body composition scan. The researchers will use the accelerometers at the wrist to measure time spent in moderate to vigorous physical activity, and the accelerometers at the ankle as an analogue for knee joint loading. The second laboratory session will consist of a 30-minute run on an instrumented treadmill (measures force of each step taken) whilst wearing non-invasive reflective markers, electromyography devices, and an accelerometer at the ankle. Participants are also invited to undergo optional repeated blood sampling to measure levels of markers of cartilage production and breakdown during rest and in response to a 30-minute run. If participants volunteer for the optional repeated blood sampling, they will be asked to attend a third laboratory session where blood samples will be taken at 24 hours after the run in the second laboratory session.

Eligibility Criteria:
Inclusion Criteria:

1. 18-39 years old (i.e., ≥18 and \<40 years old)
2. Had an anterior cruciate ligament injury and reconstruction 1-7 years ago (i.e., ≥1 and ≤7 years ago)
3. Can have sustained damage to meniscus or cartilage, or sustained bone bruising when injured anterior cruciate ligament
4. Can participate regardless of the type of reconstruction surgery and if undergone meniscectomy
5. Completed anterior cruciate ligament reconstruction rehabilitation and either a surgeon, doctor or physiotherapist has provided clearance to participate in physical activity
6. Be able to attend the University of Bath within 2 hours of waking

Exclusion Criteria:

1. Had another significant knee injury either before, at the same time, or after the anterior cruciate ligament injury (e.g., if they injured another ligament in their knee or had a fracture or dislocation)
2. Injured the anterior cruciate ligament in both knees (bilateral ACL injury)
3. Have/are experiencing a musculoskeletal, cardiovascular, respiratory, immune, metabolic or neurological disease or disorder
4. Under 18 or over 39 (i.e., ≥40) years of age
5. Body Mass Index ≥40 kg/m²
6. Pregnancy
7. Positive responses to the Physical Activity Readiness Questionnaire (aside from any involved knee joint issues)
Impact of Treatment With Targeted Therapies on the Generation of CAR T Cells in CLL Patients

In this biological study, blood samples will be collected from patients with CLL treated with targeted agents (ibrutinib and venetoclax) to assess the impact of these treatments on the generation of CAR T cells in terms of manufacturing efficiency, immunophenotypic characteristics and functional properties.

This is a biological study aimed at analyzing the features of CAR T cells generated in CLL patients treated with ibrutinib or venetoclax.

To this purpose, blood samples will be collected from patients with CLL before starting therapy with ibrutinib or venetoclax and after 6 and 12 months of treatment.

Anti-CD19 CAR T cells will be generated and tested for: (i) viability, expansion and generation efficiency; (ii) phenotypic characteristics, in terms of CD4/CD8 composition, differentiation subset distribution, exhaustion markers and expression of immune checkpoint molecules; (iii) in vitro functional properties, in terms of proliferation ability, cytokines production, cytotoxic activity and killing of target cells. CAR T cells produced from the same patient at different timepoints will be compared. Phenotypic and functional data on CAR T cells will be also correlated with main CLL prognostic factors (e.g. IGHV mutational status, FISH abnormalities, TP53 mutation status) and outcome variables (response status, duration of response).

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of CLL/SLL meeting the IWCLL 2008 criteria;
* ≥18 years old;
* Indication for treatment with targeted therapies (i.e. ibrutinib or venetoclax);
* Anticipated possibility to collect blood samples at the baseline and at 6- and 12-month timepoints;
* Signed written informed consent according to ICH/EU/GCP and national local laws;
* Confirmed availability of the laboratory to enroll and to process patient samples.

Exclusion Criteria:

* Expected treatment duration with targeted drug \< 12 months, according to treating physician;
* Previously treated with more than 2 lines of CLL-directed therapy;
* Concurrent use of systemic steroids or chronic use of immunosuppressive medications;
* Active HBV (HBsAg+ or HBV DNA+) or HCV or HIV infection.
Intraoperative Optimisation of Tissue Oxygenation

Monitoring and optimizing tissue oxygenation (StO2) in high-risk surgery and/or high-risk surgical patients may decrease the risk of postoperative complications.

Tissue hypoxia occurs frequently during high-risk surgery in high-risk patients. The investigators want to see if an algorithm aimed at optimizing intraoperative tissue oxygenation reduces perioperative complications as well as length of stay in the intensive care unit (ICU LOS), 28-day mortality, and the duration of mechanical ventilation in these patients.


Eligibility Criteria:
Inclusion Criteria:

. Major elective surgery

* Aged over 65 years with moderate functional limitation of one or more organ systems
* ASA classification III or IV, i.e. severe cardiac, vascular, respiratory or metabolic illness resulting in severe functional limitation
* Routine use of arterial and central venous lines
* Planned postoperative stay on ICU or PACU

Exclusion Criteria:

* Refusal of consent
* acute myocardial ischemia prior to enrolment
* patients receiving palliative treatment only
* disseminated malignancy
* patients unlikely to survive more than 6 hours
* emergency surgery
* transplantations
* neurosurgical patients
* patients undergoing extensive liver surgery requiring low CVP management
Safety Study of Human Milk Oligosaccharides in Healthy Adults

First-in-human phase 1 study conducted in healthy adult male and female volunteers to determine the safety and tolerability of increasing doses of PBCLN-003, which are concentrated human milk oligosaccharides (HMO).


Eligibility Criteria:
Inclusion Criteria:

* Body mass index (BMI) between 18.5 and 24.9 kg/m2
* Age between 18 and 50 years old
* No diagnosed medical conditions
* No significant change to diet in the 2 weeks prior to enrollment
* Agreement to use contraception for female subjects

Exclusion Criteria:

* Lactose intolerance
* Pregnancy
* Lactation
* Enrollment in another clinical study
A Behavioral Intervention With Foster Families

The purpose of this study is to investigate a behavioral intervention with foster families.

Study Aims: This study aims to investigate a technology-delivered family (sibling inclusive) intervention. Focus is on increasing family hardiness and preparation to care for children with disabilities and special needs in foster care. Three aims include: (1) establish the feasibility of the technology-based, family-centered intervention (2) explore in a preliminary manner the effects of the intervention on stress and relational quality outcomes among family member participants, and (3) an exploratory aim to determine feasibility and preliminary efficacy of the intervention on diurnal salivary cortisol levels within the foster family population.

Methods: This study employs a randomized control trial design of a behavioral intervention with both a control and experimental group. The intervention tested was created in partnership and adapted from the Connected Family Series (CFS) by psychologists at the Karyn Purvis Institute of Childhood Development and is called the Connected Family Series - For Foster Families (CFS-FF). Adaptation was needed as the original intervention was geared toward adoptive families and excluded foster families. The CFS-FF also needed content specific to fostering children with special needs. Stress and relational quality outcomes among members will be measured using the concepts of family hardiness, preparedness, and relationship development through a self-report questionnaire which include the Family Hardiness Index (FHI), the Integrating Foster Children (IFC) subscale from the Casey Foster Applicant Inventory (CFAI), and the Sibling Inventory of Behavior (SIB), respectively. Participation in the study spanned three to four months; one month for recruitment and collection of baseline data, one month for the intervention, and one-month post-intervention data collection. Exploratory aim 3 will be achieved by an objective indicator of stress-related biology, saliva diurnal cortisol rhythm, before and after completion of the intervention.

Eligibility Criteria:
Inclusion Criteria:

1. licensed foster families
2. must have at least one permanent child (biological or adopted) living in the home before the foster or newly adopted child entered the home
3. at least one foster or foster-to-adopt child placed in the home
4. all participants other than the foster or foster-to-adopt child must be proficient in English

Exclusion Criteria:

1. Non-English speaking
2. No permanent sibling between the ages of 7 at 17
3. No current foster placement living in the home
4. Designated as a group home
5. Greater than six children living in the home