cyrilzakka/clinical-trials huggingface dataset:
Phase 2 Study of the Safety of Diannexin in Kidney Transplant Recipients

The purpose of this study is evaluate the safety and tolerability of Diannexin in kidney transplant recipients.

Ischemia-reperfusion injury, which occurs when the blood supply to an organ, or part of an organ, is cut off and subsequently restored, is an important clinical problem in the organ transplant setting. Diannexin, a recombinant form of the endogenous human Annexin V protein, is in development as a therapeutic agent designed to prevent ischemia-reperfusion injury following organ transplantation. Pharmacology studies indicate that Diannexin has protective effect in various ischemia-reperfusion injury and organ transplantation models. Diannexin binds to phosphatidylserine on cell surfaces, which is believed to underlie its ability to attenuate ischemia-reperfusion injury. In a completed Phase 1 trial, Diannexin was judged safe and well tolerated in healthy adult subjects. The present study is designed to determine the safety and tolerability of single escalating doses of Diannexin in kidney transplant recipients.

Eligibility Criteria:
Inclusion Criteria:

* Scheduled to receive a kidney transplant from a deceased expanded criterion donor (ECD) or a donor cardiac death (DCD) donor that was exposed to no more than 36 hr of cold ischemia prior to transplantation, or scheduled to receive a kidney transplant from a standard criterion donor (SCD) that was exposed to 24-36 hr of cold ischemia prior to transplantation
* Willing to use adequate contraception for at least 4 weeks after dosing
* Willing and able to provide written Informed Consent and to comply with the requirements of the study

Exclusion Criteria:

* If female, subject is pregnant or lactating
* Known bleeding diathesis
* INR at Screening \> 1.5
* Platelet count at Screening below LLN and judged clinically significant
* Use of Plavix, anticoagulants other than aspirin, antithrombotics, and/or blood-thinning agents within 10 days prior to study entry
* Previous receipt of an organ transplant
* Will receive concurrent transplant of any additional organ(s)
* Clinically significant active infection at study entry
* Surgery within 2 weeks prior to study entry
* Believed to have used an illicit drug and/or abused alcohol within 3 months prior to study entry
* Presence of a psychiatric illness that might interfere with study participation
* Cancer, other than basal cell or squamous cell cancer of the skin, within 2 years prior to study entry
* Scheduled to receive a kidney transplant from a low risk donor
* Currently participation, or participated within 30 days prior to study entry, in an investigational drug study
* Known allergy to kanamycin
* History or presence of any medical condition or disease that could place the subject an unacceptable risk for study participation
Treatment of Multiple Gingival Recession Defects Using a New Xenogenic Collagen Membrane Compared to Connective Tissue Graft: a Randomized Controlled Split-mouth Clinical Study

Limitation of donor site and significant postoperative morbidity are often described in connective tissue graft. We want to show if mucogain matrix used in tunnel technique to recover RTI Cairo recessions defects could be an alternative to connective tissue graft


Eligibility Criteria:
Inclusion criteria:

* Patient with 3 contiguous, symmetrical and bilateral RTI Cairo gingival recessions (Miller Class 1) (i.e. 6 recessions)
* Patient non-smoker
* Patient affiliated to social security
* Patient signed informed consent.

Exclusion criteria:

* Patient with or having presented an acute or chronic severe cardiovascular, kidney, liver, gastrointestinal, allergic, endocrine, neuropsychiatric pathology, developed cancer of the upper aero digestive tract treated with radiotherapy
* Patient with severe hemorrhinopathy
* Patient treated with oral retinoids, bisphosphonates, oral or anticonvulsants
* Patient who has taken steroidal or non-steroidal anti-inflammatory therapy, anti-cancer or immunosuppressive chemotherapy within the last 6 months.
* Patient with contraindication to necessary and pre-, per- or post-operative treatments
* Follow-up of the patient seemed difficult by the investigator
* Patient with insufficient oral hygiene incompatible with oral surgery
E. Coli 83972 Induced Asymptomatic Bacteriuria (ABU) in Patients With Recurrent Urinary Tract Infections (UTI)

This study tests the following hypothesis: Does induced asymptomatic bacteriuria (E. coli 83972) protect against symptomatic urinary tract infections in individuals with bladder emptying dysfunctions and prone to recurrent infection episodes? The study is performed using a double-blind randomized study protocol with a cross-over, with re-inoculations being patient-blinded (phase 1). After patients have fulfilled the cross-over, those who have had bacteriuria or placebo-periods \< 12 months will be subjected to additional patient blinded inoculations (phase 2). During the entire study (phase 1+2) the study-team and the patients are unaware of urine culture results.


Eligibility Criteria:
Inclusion Criteria:

* Recurrent UTI
* Bladder emptying dysfunction
* Optimal conservative treatment incl. clean intermittent catheterization
* Capable of "self reporting of UTI episodes"

Exclusion Criteria:

* Malignant disease
* Immunosuppression
* Recurrent pyelonephritis
* Abnormalities within upper urinary tract, including renal stones and poor kidney function
Long-tErm Follow-uP of antithrombotIc Management Patterns In Acute CORonary Syndrome Patients in Asia

The purpose of this study is to describe the short-and long-tern (i.e. up to 2 years following the index event) AMPs in patients hospitalized for an acute coronary syndrome (i.e. STEMI or NSTE-ACS), and to document clinical outcomes, economic aspects and impact on quality of life of these AMPs in a 'real-life' setting.


Eligibility Criteria:
Inclusion Criteria:

* Written informed consent has been provided.
* Diagnosis of STEMI, NSTEMI or UA
* Hospitalization for the first time within 48 hours of onset of symptoms.

Exclusion Criteria:

* UA, STEMI, NSTEMI precipitated by or as a complication of surgery, trauma, or GI bleeding or post-PCI UA, STEMI and NSTEMI occurring in patients already hospitalized for other reasons.
* Current participation in a randomised interventional clinical trial.
Exercise and Glycemic Control in Type 2 Diabetes

Hyperglycemia is an independent risk factor for the development of diabetic complications in type 2 diabetes. Exercise improves glycemic control, however, the role of exercise characteristics (e.g. intensity, type of exercise, timing, frequency) remains to be elucidated.

This study aims to assess the effect of several exercise characteristics on hyperglycemia in various subgroups of type 2 diabetes patiënts.


Eligibility Criteria:
Impaired glucose tolerant subjects

Inclusion Criteria:

* BMI 25 - 35 kg/m2
* Impaired Glucose Tolerant (according to ADA guidelines)

Exclusion Criteria:

* Cardiac disease (cardiac event in the last 5 years)
* Type 2 diabetes
* Use of orale blood glucose lowering medication or exogenous insulin
* HbA1c \>10%

Insulin treated type 2 diabetes patients

Inclusion Criteria:

* BMI 25 - 35 kg/m2
* Insulin therapy
* diagnosed with type 2 diabetes \>2 yr

Exclusion Criteria:

* Cardiac disease (cardiac event in the last 5 years)
* HbA1c \>10%

Type 2 diabetes patients on oral blood glucose lowering medication

Inclusion Criteria:

* BMI 25 - 35 kg/m2
* diagnosed with type 2 diabetes \>2 yr

Exclusion Criteria:

* Cardiac disease (cardiac event in the last 5 years)
* HbA1c \>10%
* use of exogenous insulin
Caffeine Supplementation Improves the Cognitive Abilities and Shooting Performance of Trained E-sports Players

Purpose: investigators explored the effect of 3 mg/kg of caffeine supplementation on the cognitive ability and shooting performance of trained e-sports players. Methods: investigators recruited nine e-sports players who had received professional training in e-sports and had won at least eighth place in national-level e-sports shooting competitions. After performing three to five familiarization tests, investigators employed a randomized crossover design to divide participants into a caffeine trial (CAF) and a placebo trial (PL). The CAF group took capsules with 3 mg/kg of caffeine, whereas the PL group took a placebo capsule. After a 1-h rest, the Stroop task, visual search ability test, and the shooting ability test were conducted.


Eligibility Criteria:
Inclusion Criteria:

* had experience with national competitions and regularly underwent training in first-person shooters

Exclusion Criteria:

* no experience with national competitions and regularly underwent training in first-person shooters
* have any diseases affecting the heart, bones, and joints or diseases that preclude exercise
The Efficacy of a Psychosomatic Intervention

This study examines the efficacy of a psychosensory intervention in relation to: Resilience, Type D personality, and physiological effects (on blood pressure, heart rate and salivary cortisol) in a group of people who have self-referred for the trauma resolution psychosensory therapy - Havening Techniques (HT).

This study utilizes a single blind (researcher blind) comparison of the psychosensory therapy Havening Techniques (treatment) versus waiting list (no treatment). Participants will be assessed using resilience testing (CD-RISC), and Type D measure of personality (DS14). A subgroup of the treatment arm will be assessed for the biomarkers of blood pressure, heart rate and cortisol. This parallel-group controlled trial will examine the efficacy of Havening Techniques at 3 timepoints; baseline (Time point 1), twenty-four hours post (Time point 2) and one month later (Time point 3).

Eligibility Criteria:
Inclusion Criteria:

* Able to provide informed consent.
* Cognisant adults living in the United Kingdom.
* Will have self-referred for Havening Techniques trauma therapy.

Exclusion Criteria:

* Receiving any other therapeutic or pharmaceutical intervention in parallel.
* For the psychobiological evaluation subgroup: a history of HIV, Tuberculosis or Hepatitis B due to laboratory regulations.
Social Support Intervention for Addiction Recovery

The purpose of this research study is to determine whether using a web-based intervention is feasible, acceptable, and helpful for people who engage in hazardous alcohol use and want to cut down or quit.

This pilot study will determine the feasibility and acceptability of a novel online social support intervention (Let's Do Addiction Recovery Together!, abbreviated as LDART) that uses pre-recorded videos created by members of recovery support services to help individuals in early recovery from hazardous alcohol use sustain motivation during recovery and introduce them to freely available recovery support services in the community. The investigators will recruit participants to use the web-based intervention daily for a month; they will also fill in questionnaires about their substance use and engagement with recovery support services at the beginning and end of the study to determine preliminary efficacy.

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older
* Is at the time of study participation residing in Connecticut, USA
* Is fluent in English and has a 6th grade reading level or higher
* Alcohol Use Disorders Identification Test (AUDIT) score of ≥8
* Has had at least one heavy drinking day in the past month
* Has some desire to cut down or quit their alcohol use
* Has a smartphone or computer with access to internet

Exclusion Criteria:

* Has vulnerable population status (e.g., pregnant people, prisoners)
* Is at the time of study participation receiving in-patient psychiatric treatment involving hospitalization
The Eye in Orbit: UCF Adaption

The goal of this study is to understand the impact of space travel on the eyes. Space flight impacts numerous aspects of ocular anatomy and physiology. Current hypotheses are based on pressure changes within and around the optic nerve. Retinal and choroid blood drainage may be affected by microgravity associated cerebrospinal fluid pressure changes. Recently, a new imaging modality, Optical Coherence Tomography Angiography (OCTA), has been able to reveal micro vascular changes in the retina and choroid. To date, no microgravity ocular imaging tests have been published using OCTA. In this study the researchers aim to describe microgravity circadian choroidal and retinal vasculature using multimodal imaging including OCTA to better understand space associated ocular changes.


Eligibility Criteria:
Inclusion Criteria:

- astronauts in the AX1/Rakia mission, which was scheduled for space flight in late March 2022.

Exclusion Criteria:

* adults unable to consent
* individuals who are not yet adults (infants, children, teenagers) -
* pregnant women
* prisoners.
Prevalence of Carriers of Genetic Diseases in the Mexican Jewish Community

The Jewish Population is at an increased risk for genetic diseases, especially autosomal recessive, thus, screening should be done to determine carrier status of several genetic diseases. In the Mexican Jewish Community, which is a very diverse community (regarding geographical origins), data of carrier status is unknown. The study aims to determine carrier prevalence for over 300 diseases using commercially available panels.

Background: Preconceptional screening of genetic diseases is currently a underused and very useful tool, especially in populations that are at risk to be carriers of genetic diseases, such as the Jewish people, with carrier rates as high as 1:4 for any autosomal recessive disease. The Mexican Jewish Community is one of these populations at-risk, and there is no modern genetic research of the carrier rates in this community.

Goals: This research project in the Mexican Jewish Community aims to determine the prevalence of carriers in the community in order to properly generate in the future, a systematic carrier screening in the community.

Research Plan: The investigators propose a descriptive, observational, cross-sectional study, in which a representative sample of the Mexican Jewish Community (Which composes of Ashkenazi, Sephardic and Middle-Eastern Jews) of 250 patients, in which we´ll collect a saliva sample with a collection kit. Furthermore, the sample will be sent to a private commercial laboratory to perform the Comprehensive Carrier Screening to analyze the 301 genes included in the test plus the 13 add-on genes.

Analysis: Other demographic variables will be collected from the patients at the time of the sample collection to identify possible risk factors (geographical origin, number of Jewish grandparents, history of genetic diseases, et. al) and a correlation analysis will be performed to verify the strength of those risk factors on the carrier status of the patients.

Eligibility Criteria:
Inclusion Criteria:

* Jewish Origin in at least 1 grandparent
* Members of one of the Jewish sub-Communities in Mexico City

Exclusion Criteria:

* Pregnant Women
Evaluating the Psychophysiological Effects of a Smartphone-Based Mindfulness Task

The aim of the present study is to evaluate the psychophysiological effects of a smart phone based mindfulness meditation app (MMA) for individuals with clinically significant symptoms of major depression and/or anxiety, or symptoms of chronic pain. Specifically, the study aims to examine parasympathetic tone using HRV (primary outcome), mind-wandering and present awareness, mood symptoms, and breath focus in groups of participants who self-report clinically significant symptoms of depression and/or anxiety (DA), chronic pain symptoms (CP), as well as control participants who do not meet our criteria for either (Controls (C). All study groups will be randomized to a mindfulness meditation app (MMA+) condition or a mindfulness meditation condition without the app (MMA-) after a brief stress-induction procedure.


Eligibility Criteria:
Inclusion Criteria:

* York University students

Exclusion Criteria:

* Individuals with diagnosed cardiac conditions (e.g. coronary artery disease, arrhythmias etc) will be excluded due to confounds with heart rate variability assessment
Data Analysis for Drug Repurposing for Effective Alzheimer's Medicines (DREAM) - Tofacitinib vs Abatacept

This study aims to evaluate the comparative risk of dementia/Alzheimer's disease onset between patients treated with medications that target specific metabolic pathways and patients treated with alternative medications for the same indication.

This is a non-randomized, non-interventional study that is part of the DREAM Study of Brigham and Women's Hospital. DREAM is led by Dr. Madhav Thambisetty, MD, PhD, Chief of the Clinical and Translational Neuroscience Section, Laboratory of Behavioral Neuroscience, National Institute on Aging (NIA) intramural research program. This study aims to evaluate the comparative risk of dementia/Alzheimer's disease onset between patients treated with medications that target specific metabolic pathways and patients treated with alternative medications for the same indication using healthcare claims data.

Eligibility Criteria:
Please see https://docs.google.com/spreadsheets/d/1kUCnitJL1PpB9xkYDvBoQsKX5dnRZ6nEXhKw6p5UnlY/edit?usp=sharing or Appendix A for full code and algorithm definitions.

Medicare timeframe: 2007 to 2017 (end of data availability).

Inclusion Criteria:

* 1. No prior use of tofacitinib or abatacept anytime prior to cohort entry date
* 2. Enrollment in Medicare Part A, B, and D with no HMO coverage for 365 days prior to and including cohort entry date

Exclusion Criteria:

* 1. Prior history of dementia measured anytime prior to cohort entry date
* 2. No prior history of rheumatoid arthritis recorded in the 365 days prior to cohort entry date
* 3. Prior history of nursing home admission in the 365 days prior to the cohort entry date
Pharmacokinetic Interactions Between Atorvastatin and Metformin in Healthy Male Subjects

The purpose of the study is to assess the pharmacokinetic interactions between atorvastatin and metformin single or co-administered in healthy volunteers


Eligibility Criteria:
Inclusion Criteria:

1. Willing to adhere to protocol requirements and sign a informed consent form
2. Healthy male volunteers who are in age range of 20-55 years and the weight range is not exceed ±20% of ideal weight. Ideal weight = \[height -100\]\*0.9
3. Subjects with no history of any significant chronic disease
4. Judged to be in good health on the basis of their vital sign, ECG, physical exam and routine laboratory data for this trial by investigators

Exclusion Criteria:

1. Subjects taking inducer or inhibitor of drug metabolism enzyme such as barbital within 28days prior to study medication dosing
2. Subjects with Symptoms of acute disease within 28days prior to study medication dosing
3. Subjects with a history of gastrointestinal diseases which might significantly change ADME of medicines
4. Subjects with a history of abdominal surgery within food and water limit
5. Subjects with a history of clinically significant allergies including drug allergies
6. Subjects with anaphylaxis to atorvastatin and/or metformin
7. Subjects with a history or plan iodine radiotherapy within 28 days prior to drug administration
8. Subjects with a history of myopathy
9. Subjects with a hereditary problems, for example, galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption
10. Clinical laboratory test values are outside the accepted normal range

    * AST or ALT \>1.25 times to normal range
    * Total bilirubin \>1.5 times to normal range
    * Creatinine clearance \<90 mL/min
11. Subjects with a history of drug, caffeine and alcohol abuse(caffeine \> 5cups/day, cigarette \> 10/day, alcohol \> 30g/day) or have ever drank within 7 days prior to drug administration
12. Special diet known to interfere with the absorption, distribution, metabolism or excretion of drugs (especially, consumption of grapefruit juice) within 7 days prior to drug administration
13. Donated blood within 60 days prior to dosing
14. Participated in a previous clinical trial within 60 days prior to dosing
15. Subjects who have received any drugs that might confound the results of the trial based on medical judgement by investigators within 10days prior to drug administration
16. Subjects considered as unsuitable based on medical judgement by investigators
Sex-differential Host-microbiome CVD Risk - A Longitudinal Cohort Approach

The XCVD study investigates the influence of sex hormones on the composition of the gut microbiome and the possible emergence of cardiovascular risk factors. It will follow 200 healthy transgender individuals for two years during their hormone replacement therapy (HRT) and analyze them for the possible emergence of cardiovascular risk factors in relation to changes in the gut microbiome, metabolome, and immunome. We would also like to phenotype cardiovascular disease.

Conducting this innovative study using established scientific methods such as omics platforms, systems biology, and careful CVD phenotyping will allow, for the first time, extensive data collection on the influence of sex hormones on the development of CVD risk factors as well as the role of the gut microbiome. In doing so, the influence of circulating sex hormones can also be quantified to potentially predict CVD risk markers.

Eligibility Criteria:
Inclusion Criteria:

* Age 18-50
* Language requirements: German, English
* Previous gender hormone replacement therapy (HRT).
* Ability to give consent and written consent to participate.
* Health insurance (for clarification of incidental findings)

Exclusion Criteria:

* Diseases or functional disorders that, in the opinion of the study physician, preclude participation in the study.
* Incapacity or other circumstances that do not allow study participants to fully understand the nature, significance and scope of this study.
LiPO Teen (the Lifestyle in Pregnancy and Offspring Teenagers

The study is a follow-up of a Randomized Controlled Trial (RCT) performed in 2007-10 - the "Lifestyle in Pregnancy" LiP study.

The LiP study included 360 pregnant women with BMI ≥30 kg/m2 from Odense University Hospital and Aarhus University Hospital. The women were randomized to intervention with low-calorie diet and physical activity from gestational age 10-14 in pregnancy and until delivery - or to a standard care control group. The objective of the LiPO-Teen project is to perform a clinical follow-up study of the eligible 301 mothers who completed the trial until delivery with a liveborn child, and their 14 year-old offspring. The overall ambition is to understand whether lifestyle intervention in pregnancy prevents obesity and its complications across generations, with a specific focus on modifiable factors.

LiPO Teen (the Lifestyle in Pregnancy and Offspring Teenagers): Identification of modifiable risk factors for childhood obesity - a follow-up of a randomized controlled trial.

The objective of the LiPO-Teen project is to perform a clinical follow-up study of the eligible 301 mothers who completed the trial until delivery with a liveborn child, and their 14 year-old offspring.

In the original trial women were randomized 1:1 to intervention or control. The participants (both mother and child in pair) who completed the initial LiP study will be invited to a 2-hour examination now 14 years after the intervention during pregnancy to evaluate the effect of the intervention on both mother and child long term.

Eligibility Criteria:
Inclusion Criteria:

* Mothers in the initial LiP study selected at the baseline study in 2007-2010
* Teenagers of mothers in the initial LiP study

Exclusion Criteria:

• None