cyrilzakka/clinical-trials huggingface dataset:
Gene Therapy for Patients With Leukocyte Adherence Deficiency (Follow-Up of Phase 1 Trial)

This study will provide long-term monitoring of two patients who received gene therapy for leukocyte adherence deficiency (LAD) under the Food and Drug Administration investigational new drug study BB-IND-7949. The IND protocol has been closed. No other patients are eligible for this study.

Patients previously enrolled in BB-IND-7949 (Retrovirus-Mediated Transfer of the cDNA for Human CD18 into Peripheral Blood Repopulating cells of Patients with Leukocyte Adherence Deficiency) will be followed at least yearly for an indefinite period of time to evaluate their medical status and look for treatment side effects. The follow-up visits at the NIH Clinical Center will involve the following:

* Interview regarding health status during the past year
* Blood draw of approximately 15 milliliters for 3 years, then 5 ml annually thereafter for studies related to LAD and to make sure no unexpected effects of gene therapy have occurred

The blood samples collected at the follow-up visits will be frozen and stored. If a serious medical problem arises, the sample may be checked for replication competent virus. If the gene therapy is suspected to be related to a medical problem, investigation may include a review of the patient's medical records or collection of additional blood or tissues for testing. If the patient should die, the family will be asked permission to perform an autopsy, regardless of the cause of death. Tissues taken at autopsy will be tested for any long-term effects from the gene therapy.

Patients with leukocyte adhesion deficiency or LAD have a deficiency of the leukocyte integrin CD18 on their leukocyte cell surface and suffer from severe bacterial infections. Two patients with LAD were enrolled in a Phase I clinical trial conducted at the University of Washington School of Medicine in 1999 to determine the safety and potential efficacy of using retroviral vectors containing CD18 to transduce and correct their CD34+ peripheral blood stem cells. This protocol aims to continue the long-term follow-up of these patients at the National Cancer Institute where Dr. Hickstein is now a Senior Investigator. Blood samples will be collected at the follow-up visits on the yearly anniversary of the treatment date (either locally or off-site by the patients' personal physicians) for archiving for potential testing for replication competent retrovirus, and for complete blood counts. Patients will also undergo a history and physical examination at these visits. Results from these tests will be forwarded to the investigators who will report to the NIH and FDA.

Eligibility Criteria:
* Two patients treated under FDA IND BB-IND-7949.
Metabolic Profile of Users of Hormonal and Non-hormonal Contraceptives

Evaluation of metabolic profile of users of hormonal and non-hormonal contraceptives during five years follow-up

Were eligible for the study 489 Women, followed in Federal University of São Paulo Family Planning Service, who used the same contraceptive method during five year of follow-up, According to the service protocol, the patients, after had participated of a orientation group about contraceptives methods, elected one of them. After that, if the choice had been according to the eligibility criteria of World Health Organization, it was approved by a gynecologist.

The contraceptive methods available were the intrauterine device (IUD) oral contraceptives, including combined pills and progestin-only formulations, and depot medroxyprogestereone acetate.

The study consisted in the evaluation of their medical records of weight, BMI, Blood pressure, glycemia, seric levels of cholesterol and triglycerides, during the five years, and in the comparison of the differences of these data between the contraceptive methods.

Eligibility Criteria:
Inclusion Criteria:

* women in reproductive age followed in Federal university of Sao Paulo Family Planning Service
* use of the same contraceptive method during five years

Exclusion Criteria:

* incomplete data
Effect of Coffeeberry on Mood, Motivation and Cognitive Performance

The primary purpose is to test the short-term effects of the acute consumption of two novel beverages made from coffeeberries, the fruit of the coffee plant (Coffea arabica) benchmarked against caffeine on several aspects of cognitive performance.

Preliminary studies suggest that flavanols and chlorogenic acids can enhance cognitive performance. It is unknown if drinks formulated with flavanols and chlorogenic acids (without high sugar or caffeine) improve cognition or mood to a similar extent as caffeine. Coffeeberry beverage comparisons will be made to a flavored positive control beverage containing caffeine and a flavored placebo beverage.


Eligibility Criteria:
Inclusion Criteria:

* Are older than 17 and under 50 years of age
* Self-report of good health

Exclusion Criteria:

* Using any prescription medication including birth control
* Report hypersensitivity to caffeine
* Have visual impairment that cannot be corrected with glasses or contact lenses
* Report any food allergies
* Self-reported excessive leisure time physical activity (\> 7 strenuous bouts per week)
* the presence of current gastrointestinal, sleep, or psychiatric disorder,
* Report pregnancy/lactation, illegal drug use, smoker
* failure to demonstrate adequate minimal performance on lab, computer-based cognitive tasks.
* Participation in another clinical trial within past 30 days
A Study of Evacetrapib (LY2484595) in Healthy Participants

The purpose of this study is to measure and compare the amounts of the study drug evacetrapib found in the blood after taking two different formulations. The study has 3 periods. Participants will take each formulation by mouth at least once. A minimum of 14 days will pass between study drug doses. The safety and tolerability of the study drug will also be examined. Information about any side effects that may occur will also be collected. This study will last approximately 6 weeks.


Eligibility Criteria:
Inclusion Criteria:

* Male participants who agree to use a reliable method of birth control and not donate sperm during the study and for 90 days after study completion
* Female participants who are not of child-bearing potential due to surgical sterilization confirmed by medical history or menopause
* Have a body mass index of 18 to 32 kilograms per square meter (kg/m\^2)
* Are reliable and willing to make themselves available for the duration of the study and are willing to follow study procedures

Exclusion Criteria:

* Are currently enrolled in or have completed or discontinued within the last 30 days from a clinical trial involving an investigational product
* Have known allergies to evacetrapib, related compounds or any components of the formulation, or history of significant allergic disease as determined by the investigator
* Have a history or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, or neurological disorders
* Regularly use known drugs of abuse and/or show positive findings on urinary drug screening
* Are women who are pregnant or lactating
* Have used or intend to use over-the-counter or prescription medications (including vitamins/mineral supplements, herbal medicine) 14 days prior to enrollment and during the study
* Have donated blood of more than 500 milliliters (mL) within the last month
* Have an average weekly alcohol intake that exceeds 21 units per week (for males) and 14 units per week (for females) or are unwilling to stop alcohol consumption 48 hours prior to each dose and while resident at the Clinical Research Unit (CRU)
* Currently smoke or use tobacco or nicotine products
Randomized Study for Effectiveness and Safety Evaluation of Dexamethasone 0.5 mg + Fumarate Clemastine 1 mg Compared to Dexamethasone 0.5 mg in Patients With Allergic Dermatitis

The aim of this study is to prove the efficacy of the dexamethasone 0.5 mg + 1 mg clemastine fumarate tablet compared to 0.5 mg of dexamethasone in reducing the signs and symptoms of allergic dermatitis.


Eligibility Criteria:
Inclusion Criteria:

* Patients who sign the IC in two ways, agreeing with all study procedures
* Patients aged above 18 years of any ethnicity, class or social group, female or male
* Patients with acute, subacute or chronic dermatoses, of inflammatory and / or allergic origin, to which it is recommended the use of drugs under investigation, such as:

  * atopic dermatitis
  * prurigo
  * primary contact dermatitis or allergic hives
  * drug eruption
  * allergic vasculitis
  * dyshidrosis, Note: The above clinical conditions are diagnosed from clinical examination.

Exclusion Criteria:

* Patients being treated with antibiotics
* Participation in clinical trials in the 12 months preceding the investigation
* Current treatment with immunosuppressants (eg, cyclosporine or methotrexate)
* Current treatment with phototherapy (UVA, UVB, PUVA and lasers)
* Use of systemic corticosteroids in the visit to include or 15 days preceding the survey
* Topical treatments at the site of lesions in the 15 days preceding the survey
* Presence of any skin condition
* Presence of secondary infections at the site of treatment, diagnosed clinically;
* Presence of other eczematous diseases, such as nummular eczema, neurodermatitis, seborrheic dermatitis, psoriasis, scabies, and Buckley's syndrome
* Pregnant or lactating women
* Chronic alcoholism
* Patients with a history of hypersensitivity to any component of the products under investigation.
* Any finding of clinical observation (clinical history or physical examination) that is interpreted by the physician investigator as a risk to the patient's participation in the study.
* Allergic Dermatosis mild or, acording to the investigator criteria, is not justified systemic treatment.
Effect of Compound Sodium Chlorate and Aminophylline Tablets on Chronic Obstructive Pulmonary Disease(COPD).

Acute exacerbation of chronic obstructive pulmonary disease (AECOPD) is an important event in the management of chronic obstructive pulmonary disease. Compound sodium chlolate and aminophylline tablets are one of the most widely used drugs for the treatment of bronchial asthma and chronic bronchitis.

Acute exacerbation of chronic obstructive pulmonary disease (AECOPD) is an unignorable event in the management of chronic obstructive pulmonary disease. It is crucial to seek for effective management strategy. Compound sodium chlolate and aminophylline tablets are one of the most widely used drugs for the treatment of bronchial asthma and chronic bronchitis. Compared with the local bronchodilator recommended by the guidelines, it has the advantages of convenient use and good patient compliance. For the purpose of optimize the management of acute exacerbation of chronic obstructive pulmonary disease and provide more convenient options, we compared the efficacy of combined compound sodium chlolate and aminophylline tablets with nebulized ipratropium bromide inhalation plus systemic glucocorticoids in the treatment of chronic obstructive pulmonary disease ranging from moderate degree to severe degree. We hope this research would benefit patients with chronic obstructive pulmonary, especially those in the grassroots.

Eligibility Criteria:
Inclusion Criteria:

- (1)All subjects must sign an informed consent form before participating in the clinical trial.

(2)Clinical diagnosis of AECOPD. (3)Must be able to swallow tablets.

Exclusion Criteria:

* (1)Heart disease. (2)Insulin dependent diabetes. (3)Tumor disease. (4)Thyroid disease. (5)Infectious diseases such as hepatitis B, active tuberculosis, etc. (6)Active peptic ulcer. (7)Allergic to related treatments. (8)Participate in other clinical trials within three months. (9)Women who are breast-feeding, pregnant or preparing for pregnancy.
Smart Life Smart Living Intercontinental - Medical Students' Cohort

The question of the well-being, quality of life and mental health of care students is unanimously considered to be a central issue among young adults. According to the French Ministry of Higher Education and Research, there will be 194,752 care students in France in 2021-2022. The quality of life and well-being of health students can be affected at several levels. The first is mental health. In France, the mental health of these students has deteriorated considerably in recent years. According to a 2017 survey of 21,768 French medical students, 66% of them had an anxiety disorder and 27% a depressive syndrome. In addition, a number of risk factors have been identified for the mental health of health students.

The aim of the study is to carry out a longitudinal evaluation of the mental health status of care students during their university studies in France through anxiety, depression and perceived stress.


Eligibility Criteria:
Inclusion Criteria:

* students who are regularly enrolled in healthcare courses at a French university

Exclusion Criteria:

* Age under 18
Safety and Tolerability of IC83/LY2603618 Administered After Pemetrexed 500 mg/m2 Every 21 Days in Patients With Cancer

The purpose of this study is to evaluate the safety and tolerability of IC83/LY2603618 for the treatment of cancer.


Eligibility Criteria:
Inclusion Criteria:

* Has at least one lesion that can be evaluated by Response Evaluation Criteria In Solid Tumors (RECIST)
* Has fully recovered from all toxicities due to the following:

  1. Local radiation therapy that ended at least 14 days prior to Cycle 1, Day 1.
  2. Surgery.
* Has a life expectancy of at least 3 months.
* Negative serum pregnancy test.

Exclusion Criteria:

* Is pregnant or breastfeeding.
* Is a woman of childbearing potential unwilling to use an approved, effective means of contraception according to the institution's standards.
* Is a man of childbearing potential unwilling to use an approved, effective means of contraception according to the institution's standards.
* Has a history of brain metastases, unless adequately treated and without radiologic evidence of progressive disease for at least 3 months after completion of therapy.
* Has a known active infection.
Histiocytosis in Injecting Drug Users

The goal of this observational study is to describe a new disease condition of histiocytosis related to injecting drug use, its preconditions, symptoms, signs, findings, and prognosis in a detailed and systematic patient series in one referral center. The main question\[s\] it aims to answer are:

* to find specific histologic features in different tissues to help the differential diagnosis from other histiocytoses
* to describe the value of chitotriosidase activity to screen this condition
* to describe the value of various tissue biopsies in confirming the diagnosis
* to describe the nature of polyvinylpyrrolidone accumulation in tissue macrophages by novel special microscopic techniques
* to find new tandem mass spectrometry methodology to prove polyvinylpyrrolidone accumulation in macrophages
* to show that polyvinylpyrrolidone treatment activates macrophages to histiocytes and causes povidone accumulation within the cells in in vitro experiments
* to evaluate the pathology of macrophage activation to histiocytes by transcriptomics

The patient history will be collected from the data produced by follow-up of cases followed up in a single center. A subgroup of participants will be given an opportunity to sign informed consent to give access to/donate blood and tissue samples to search for techniques to prove polyvinylpyrrolidone storage within histiocytes, and to search for transcriptomics signal(s) in histiocytes.

Researchers will compare blood and tissue samples from the biobank as controls.

We will search for comprehensive patient data (disease history, findings, complications, laboratory findings, histopathology, and imaging) from patient records of a single university hospital. Coded histiocytosis-positive tissue samples will be compared to biobank samples from corresponding tissues from healthy and other other histiocytosis tissue samples to show polyvinylpyrrolidone storage with novel methodologies.

In addition, if study participant who is followed up, signs informed consent, monocytes are separated from a blood sample, differentiated to macrophages, and exposed to polyvinylpyrrolidone. Various novel methods will be utilized to explore polyvinylpyrrolidone within histiocytes.

Eligibility Criteria:
Inclusion Criteria:

* All identified adult patients in our records with a history of injecting drug use by dissolving tablets containing polyvinylpyrrolidone and (suspected) PVP-histiocytosis

Exclusion Criteria:

* Other histiocytosis diagnosed by tissue samples and clinical information
A Four Week Study of Azithromycin Ophthalmic Solution, 1% Versus Vehicle in Subjects With Blepharitis (P08636)

The purpose of this study is to compare the safety and efficacy of azithromycin ophthalmic solution, 1% versus vehicle over a four-week treatment period in treating the signs and symptoms of subjects with blepharitis and to evaluate the clinical course of the condition under study.


Eligibility Criteria:
Inclusion Criteria:

* Have a current diagnosis of blepharitis
* Have a best corrected visual acuity (BCVA), using corrective lenses if

necessary, in both eyes of at least +0.7

* If female, are non-pregnant or non-lactating

Exclusion Criteria:

* Have a concurrent acute hordeolum (stye) or chalazion
* Have inflammation of the ocular surface
* Have used artificial tears within 48 hours prior to Visit 1 or anticipate

using during the study

* Have had ocular surgery in the past 90 days or will require it during the

study

* Unable to withhold the use of contact lenses during the study
* Have a known hypersensitivity to azithromycin, erythromycin, any other

macrolide antibiotic, or any of the other ingredients in the study

medication

* Have been diagnosed with ongoing glaucoma
* Unable to withhold the use of ocular cosmetic products within 48 hours

prior to Visit 1 and throughout the study

* Have a serious medical condition which could confound study assessments
Drug-Coated Coronary Balloons in Different Clinical Scenarios

Coronary stents are the best treatment method ever accepted in the treatment of coronary artery stenoses. Due to some limitations and complications of stent use, the operators tried to find new solutions. Drug Coated Balloons (DCBs) have been accepted as a new method in the treatment of in-stent restenosis and small vessel disease. Furthermore, they have been used in the treatment of de novo coronary lesions, chronic total occlusions and bifucation lesions. But data is limited in the short and long term success of DCBs in all these clinical scenarios. In our study we aimed to investigate the procedural success and short and long term outcomes of DCB use in different clinical scenarios.


Eligibility Criteria:
Inclusion Criteria:

* Patients treated with drug coated balloons

Exclusion Criteria:

* Patients treated with other than DCBs
A Food Effects Study and Optional Multi Dose Study to Assess PK of BTD-001

This is a single-centre, open-label study in healthy male and non-pregnant, non-lactating females. The study will consist of up to 2 parts; the decision to proceed to the optional second part will be made following review of Part 1 data.

Part 1 is a single dose, two period crossover to assess food affect of oral BTD-001.

Optional Part 2 is a non-randomised, single arm study multi dose design to evaluate PK profile of BTD-001


Eligibility Criteria:
Inclusion Criteria:

* Healthy adult males and non-pregnant, non-lactating females aged 18-55 years old
* BMI between18.0-35.0 kg/m2 unless investigator deems not clinically significant
* Provide written consent
* Agrees to protocol specified contraception

Exclusion Criteria:

* Received any investigational treatment within last 3 months
* Subjects who are study site employees, or immediate family members of a study site or sponsor employee
* Subjects who have previously been enrolled in this study
* History of any drug or alcohol abuse in the past 2 years
* Regular alcohol consumption in males \>21 units per week
* Current smokers and those who have smoked, including nicotine replacement or e-cigarates within the last 12 months.
* Subjects who do not have suitable veins for multiple venepunctures/cannulation as assessed by the investigator at screening
* Clinically significant abnormal lab results
* Positive drugs of abuse test result
* Positive hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV Ab) or human immunodeficiency virus (HIV) results
* Evidence of renal impairment at screening
* History of or current seizure disorder or history of syncope, unexplained loss of consciousness or seizure in the past 3 years
* Clinically significant medical/psychiatric history findings, or physical/neurological examination findings or significant history of or current suicidal ideation or behaviour
* History of or current significant pulmonary, cardiac, renal, hepatic, chronic respiratory, gastrointestinal, neurological or psychiatric disease, substance dependence, porphyria, malignancy (with exception of local cutaneous squamous or basal cell carcinomas or local cervical squamous cell cancer resolved after resection) or hypothyroidism
* Subjects with QT interval corrected for heart rate according to Fridericia's formula of \>430 msec in males and \>450 msec in females
* Serious adverse reaction or serious hypersensitivity to any drug or the formulation excipients
* Presence or history of clinically significant allergy requiring treatment, as judged by the investigator. Hayfever is allowed unless it is active
* Donation or loss of greater than 400 mL of blood within the previous 3 months Subjects who are taking, or have taken, any prescribed or over-the-counter drug (other than up to 4 g per day paracetamol,hormone replacement therapy and hormonal contraception) or herbal remedies
* Failure to satisfy the investigator of fitness to participate for any other reason
A Multicenter, Active and Placebo-controlled Study of Enteric Coated Sevelamer in Patients With Mild to Moderate Hypercholesteremia

A total of 120 patients will be entered in this study to assess the safety and efficacy of enteric coated sevelamer (ECS) to lower LDL cholesterol. Patients will be randomized into two active treatment groups, two placebo groups and one active control group.

This is a prospective, randomized, single blind, active and placebo-controlled, parallel-group, multi-center study.

Two groups of ECS consisting of 3 and 6 tablets/day (n=30), two placebo groups of 3 and 6 tablets/day (n=15 each) and one active control group of colesevelam 6 tablets/day (n=30). The study is being conducted solely in India and there will be a total of 6-8 sites.

The safety parameters are:

* Serious adverse events SAEs
* Treatment and non-treatment emergent AEs
* Physical exams and vital signs
* Clinical safety laboratories

The efficacy parameters include a fasting lipid profile:

* Low density lipoproteins (LDL)
* Total cholesterol
* High density lipoproteins (HDL)
* Triglycerides

Eligibility Criteria:
Inclusion Criteria:

* Males and females 18 years of age or older
* Clinical diagnosis of mild to moderate hypercholesterolemia 1)LDL cholesterol greater than or equal to 130 mg/dL and less than or equal to 220 mg/dL 2) Triglycerides less than or equal to 300 mg/dL

Exclusion Criteria:

* Women who are pregnant or lactating.
* Patients using other lipid-lowering medications during .
* Patients with unstable medical conditions and/or comorbidities