cyrilzakka/clinical-trials huggingface dataset:
Undiagnosed COPD and Asthma Population Study (UCAP)

Previous population health studies suggest that up to 10% of Canadian adults have undiagnosed asthma or COPD- these people are currently undiagnosed and untreated, even though they may have significant respiratory symptoms. Our study will use targeted casefinding to find people with undiagnosed asthma and COPD in Canadian communities. The investigators will assess their symptoms and their health care use and number of sick days to determine the burden of undiagnosed respiratory disease in these people. The investigators will then determine whether early treatment of previously undiagnosed airflow obstruction will improve patients' health outcomes.


Eligibility Criteria:
Inclusion Criteria:

* Subjects at least 18 years old;
* Subjects who score \> or = to 6 points on The Asthma Screening Questionnaire or \> 19.5 points on The COPD Diagnostic Questionnaire;
* Subjects who have given written informed consent to participate in this trial in accordance with local regulations;
* Subjects able to perform pre and post bronchodilator spirometry to measure lung function;

Additional Inclusion Criteria for RCT:

Those subjects who have undiagnosed airflow obstruction (i.e. Asthma will be diagnosed in subjects with airflow obstruction whose FEV1 improves by \> 12% and 200 ml after bronchodilator and COPD will be diagnosed in subjects who do not have a significant bronchodilator response and who exhibit persistent airflow obstruction post bronchodilator) will be asked to consent and participate in the RCT.

Exclusion Criteria:

* Subjects who report a previous physician diagnosis of asthma.
* Subjects who report a previous physician diagnosis of COPD
* Subjects with any of the following conditions within the past 3 months: Heart attack or hospitalization for other heart problems; Stroke; Aortic or cerebral aneurysm; Detached retina or eye surgery
* Subjects who are in the third trimester of pregnancy
* Subjects involved in another interventional trial
Diagnostic and Screening Study of Genetic Disorders

OBJECTIVES: I. Determine the phenotypic heterogeneity of patients with genetic disorders including their clinical spectrum and natural history.

II. Develop and evaluate novel methods for the treatment of genetic disorders including metabolic manipulation, enzyme manipulation, enzyme replacement, enzyme transplantation, and gene transfer techniques in these patients.

III. Develop and evaluate methods for the prenatal diagnosis of genetic disorders using improved cytogenetic, biochemical, and nucleic acid techniques and amniotic fluid cells or chorionic villi in these patients.

PROTOCOL OUTLINE:

Patients are evaluated annually or biannually, depending on disease status and progression. Patients undergo a complete medical history, an extensive family pedigree, and a physical examination. Patients undergo general laboratory, imaging, physiologic, and clinical laboratory studies according to their disease type. Patients undergo specialized laboratory studies including plasma and leukocyte enzyme assays, quantitative urinary mucopolysaccharides and oligosaccharides, urine and plasma glycolipids, plasma and urine amino acids, urine organic acids, lymphoblastoid culture, DNA isolation from peripheral leukocytes, skin biopsy for fibroblast culture (if indicated), and medical photography. Patients also receive consultations with various specialties including ophthalmology, ENT, cardiology, pulmonary, gastroenterology/nutrition, hematology, neurology, orthopedics, rehabilitation medicine/physical therapy, and dermatology.

Eligibility Criteria:
* Suspected diagnosis (homozygous or heterozygous) of a genetic disorder including, but not limited to, one of the following: Tay-Sachs disease (adult form) Congenital erythropoietic porphyria Galactosemia Mitochondrial myopathy Globoid cell leukodystrophy (Krabbe disease) Methylmalonic acidemia Isovaleric acidemia Morquio type A Glycogen storage disease type 1AB Ornithine aminotransferase deficiency Ceroid lipofuscinosis Glutaric aciduria type 1 Citrullinemia Other malformation syndromes, lysosomal storage disorders, or peroxisomal disorders
A Non Interventional Study With Irinotecan Onkovis (Irinotecan) Utilized for the Treatment of Cancer

The main purpose of this observational study with Irinotecan onkovis is to determine the number of treatment cycles and the quantity of Irinotecan onkovis needed for this purpose under the special circumstances of ambulant chemotherapy.

Onkovis aims to contribute to an economical utilization of the chemotherapeutics. This includes provision of appropriate packaging sizes to decrease the excess quantity to be discarded, and thus also follows this objective.

Secondary objective is the assessment of the side effects of Irinotecan onkovis. To this end, data regarding co-medication and adverse events are also collected.


Eligibility Criteria:
Inclusion Criteria:

* Indication for Irinotecan according to the SmPC and treating physician

Exclusion Criteria:

* according to the Irinotecan SmPC
Efficacy And Safety Of Heparin In Patients With Cardiovascular Surgery Using Cardiopulmonary Bypass

The primary objective of this study is to verify, through a randomized, blinded, parallel clinical trial, the efficacy of bovine heparin from Eurofarma Laboratory product when compared to porcine heparin APP Pharmaceutical in patients undergoing surgery cardiovascular disease and who require cardiopulmonary bypass, through the control of hemostasis during and after surgery, based on measurements of markers of coagulation ACT, aPTT, anti-Xa heparin levels and the excessive blood loss (hemorrhage) after the end of surgery.


Eligibility Criteria:
Inclusion Criteria:

* Patients who agree with all aspects of the study and sign the FICT;
* Patients of both sexes;
* Patients over the age of 18 years;
* Patients with indication for cardiac surgery requiring cardiopulmonary bypass.

Exclusion Criteria:

* Patients with hematological disorders that compromise the surgical outcome (eg, myeloproliferative disorders, anemia, Hb \<11.0 g / dL, platelets \<100,000 mm3);
* Patients with disorders of hemostasis (INR\> 1.40) (APTTr\> 1.40);
* Patients with renal impairment (creatinine\> 1.50);
* Patients with deep hyperthermia;
* Liver disease (AST and ALT\> 2 times that of the reference value);
* Patients with a history of allergy to heparin or protamine;
* Patients with a history of heparin-induced thrombocytopenia;
* infection (eg endocarditis, septicemia and pneumonia);
* Reoperations;
* Use of antiplatelet agents (clopidogrel and ticlopidine) for less than 7 days;
* Use of aspirin for less than 5 days;
* Use of heparin, low molecular weight less than 24 hours;
* Use of unfractionated heparin for less than 12 hours.
Pharmacokinetics and Safety of 'CG-745 IV' and 'CG-750' in Healthy Male Adults

A randomized, placebo-controlled, dose-escalation, crossover study.

Total of 24 health volunteers will be randomized to receive either of Cohort 1,2 or 3. (8 subjects each)

\[Cohort 1\] Subject will fast for at least 10 hours in first treatment, and then be administrated with CG-745 IV or placebo. After 2-week rest period, subject will fast for at least 10 hours in second treatment, and then be administrated CG-750 capsule or placebo with 150 mL of water.

\[Cohort 2\] The recommended dose of capsule in cohort 2 will be determined based on the bioavailabilty and safety data of cohort 1.

Subject will fast for at least 10 hours in first treatment, and then be administrated with CG-745 IV or placebo. After 2-week rest period, subject will fast for at least 10 hours in second treatment, and then be administrated the determined dose of CG-750 capsules or placebo with 150 mL of water.

After 2-week rest period, subject will take the high fat diet and then be administrated the determined dose of CG-750 or placebo with 150 mL of water.

\[Cohort 3\] The recommended dose of capsule in cohort 3 will be determined based on the bioavailabilty of cohort 1 and 2.

Subject will fast for at least 10 hours in first treatment, and then be administrated with CG-745 IV or placebo. After 2-week rest period, subject will fast for at least 10 hours in second treatment, and then be administrated the determined dose of CG-750 or placebo with 150 mL of water.

Eligibility Criteria:
Key Inclusion Criteria:

* Subject who signed voluntarily the written agreement after understanding the purpose, contents, the properties and expected adverse effects of investigational product
* Subject who is considered to be appropriate for the study according to the judgment of investigator based on physical examination, clinical laboratory test, electrocardiogram, vital sign and questionnaire

Key Exclusion Criteria:

* Subject with clinically meaningful and relevant disease in liver, kidney, nervous system, respiratory system, endocrine system, blood and tumor, cardiovascular system, urinary system and mental system
* Subject with sensitive reaction in HDAC inhibitor or another drug
* Subject who participated in another clinical trial or bioequivalent study with past 6 weeks
* Subject who is not considered to be appropriate for the study according to the judgment of investigator
The Role of Expectancy for Cognitive Enhancement in College Students Using Prescription Stimulants Nonmedically

We propose to evaluate the interaction between expectations of receiving stimulants, neurophysiological activity and enhancement of cognitive performance using fMRI.

Participants will then be randomized in a balanced placebo design (BPD) crossing medication (10 mg of mixed amphetamine salts vs placebo) and expectancy (told active medication vs placebo medication), resulting in 4 different conditions 1) mixed amphetamine salts/told stimulant medication; 2) placebo/told stimulant medication; 3) mixed amphetamine salts/told placebo; and 4) placebo/told placebo). Participants will be assigned to four scanning sessions scheduled one week apart and will experience each condition once counterbalanced across participants. Participants will be administered cognitive tasks in and out of the scanner to determine the effects of medication vs expectancy.

Eligibility Criteria:
Inclusion Criteria:

* 18-30 years old
* enrolled as a student at UAB or local college/university
* if female, willing to use adequate birth control or abstain from sexual activity

Exclusion Criteria:

* current or prior head injury
* current or prior psychiatric diagnosis (including ADHD)
* neurological disorder or stroke, hypertension, history of blood or circulation disorders (e.g., anemia or sickle-cell), diabetes, brain or spinal abnormalities
* blood pressure more than 130 systolic and 80 diastolic
* heart rate more than 100 beats per minute
* pregnancy
* current illicit substance use as well as nicotine use
* Alcohol or cannabis use that meets DSM-5 criteria for an alcohol or cannabis use disorder
* Inability to abstain from alcohol or cannabis the night before and day of the scanning session
* Inability to reduce caffeine intake to less than 100 mg on testing days in heavy caffeine users
* claustrophobia
* hearing impairment
* vision impairment that cannot be corrected by MRI-compatible lenses
Severe Immune Cytopenia Registry Www.Sic-reg.Org

Prospective registry study for children and young adults with severe immune cytopenias (persisting/chronic immune thrombocytopenia, autoimmune hemolytic anemia, and Evans syndrome) to improve the management, facilitate the differential diagnostic work-up, and document the clinical course under various treatments.

Time points: at inclusion, after 6 months, after 12 months, then yearly up to 4 years after inclusion.

No intervention, mere observation and documentation. Guided pre-inclusion (differential) diagnostic work-up.

The study aims to improve the management and care of patients with severe immune cytopenias, to identify underlying causes of severe immune cytopenias and to develop a strategy for early treatment stratification based on a standardized diagnostic algorithm, potentially supported by biomarker analyses and (off study) genetic analyses, where clinically indicated.

Primary Goal:

Rapid detection of underlying causes of severe immune cytopenias with the aid of a structured diagnostic approach and access to a clinical care network of the participating centers, allowing early treatment stratification

Secondary Goals:

* Collection of data about epidemiology of rare diseases
* Systemic documentation of response rates to various treatments
* Identification of biomarkers and modifiers of immune tolerance
* Collection of data about the usage of novel/experimental therapeutic agents
* Documentation of physician-reported outcome measures/performance scores
* Consultation of the caring physicians through a regular SIC-Reg board

There will be no additional venous punctures or investigational time points. At clinical visits around planned study time points, additional blood parameters and stool specimen will be obtained. The current clinical management follows international guidelines, which are summarized in the study documents but do not represent part of the study (no diagnostic or therapeutic investigational arm).

Eligibility Criteria:
Inclusion Criteria:

* Autoimmune hemolytic anemia (AIHA)
* Evans syndrome (ES)
* Persistent or chronic immune thrombocytopenia (ITP; \>6 months after first manifestation)

Exclusion Criteria:

* (history of) malignancies
* (history of) hematopoietic stem cell transplantation
The Aim of Study is Translate and Adapt the Visual Analog Scale Foot and Ankle (VAS-FA) Instrument Into Turkish and Psycho-metrically Test Its Reliability and Validity Among Patients Who Had Foot and Ankle Disorders or Surgery

There have previously been no validated a specific foot and ankle patient-reported outcome measures in Turkish. The Visual Analogue Scale Foot and Ankle (VAS-FA) will translated and adapted into Turkish language. Thereafter, 200 patients who had foot and ankle disorders or surgery will complete VAS-FA questionnaire set on two separate occasions. Analyses included testing of ﬂoor-ceiling effect, internal consistency, reproducibility, and validity.


Eligibility Criteria:
Inclusion Criteria:

* Age between 18 and 65
* Participants who have foot and ankle disorders
* Participants must have an orthopedic intervention last 3 months;

  1. Conservative intervention
  2. Surgery intervention

Exclusion Criteria:

* Age less than 18 or more than 65
* Positive medical history concerning the entire lower extremity,

  1. Diabetes mellitus
  2. Drug abuse
  3. Psychiatric diseases
  4. Rheumatoid arthritis
  5. Neurological diseases
Estimation of Alcohol, Substance and Cigarettes Exposure Among Pregnant Women in the Israeli Periphery and Center, and the Contribution of Brief Intervention

The aims is to evaluate the rate of exposure to alcohol, psychoactive substance and nicotine among pregnant women in periphery hospital (Poria) and in the center of Tel Aviv (Ichilov) and to evaluate study Brief Intervention impact on reduction exposure, and its effect on newborn outcomes.

All pregnant women who will arrive to Poria (and third of pregnant who will arrive to Ichilov) ER, high risk, and follow-up clinic will be asked for alcohol exposure, smoking and psychoactive substance usage. Relevant women will be asked to participate in a brief intervention treatment for about 30 min by expert personal, and a follow-up by phone every 3 months during pregnancy and post deliver. In addition, through all the year, questionnaires about exposure will be given to all women who will have labor (about 3000 labors), and third of 10,000 expecting in Ichilov. We expect in the second half of the year, to have those who enrolled to the BI. New-born outcome of the BI group as compared to the non-BI group will be compared, as well as rate of alcohol/substance/nicotine abstinence and reduction.

Eligibility Criteria:
Inclusion Criteria:

* pregnant women who smoke cigarets, drink alcohol and or abuse any drugs

Exclusion Criteria:

* pregnant women who do not smoke cigarets, drink alcohol and or abuse any drugs
Effects of Ramadan Fasting on Sleeping and Quality of Life

Include participants who intend to practice Ramadan fasting and accept to complete the three part of the study .

All volunteers and stable patients that intend to fast ramadan. Each participant is examined during three separate visits.

The week before Ramadan (Pre-R). the last week of Ramadan (R). the last week of the month following Ramadan (Post-R). Participants that miss one appointement or more are exluded from the study. Patient recrutement is conducted in primary care centers of the state of Monastir, out-patients clinic (Cardiology, Endocrinology) at the emergency department of Fattouma Bourguiba university hospital after a clarified written consent.

All patients benifit of a routine examen and evaluation of the quality of life by Short Form 36 (SF36) test and sleeping by Pittsburg Sleep Quality Index (PQSI) score .

Eligibility Criteria:
Inclusion Criteria:

* Adult patient intending to fast Ramadan.

Exclusion Criteria:

* Age \< 18 years old
* Hemodynamic instability.
* Myocardial infarction requiring urgent revascularization.
* Parkinsonism: tremor problem.
* Refusal, communication problem.
Research Into Diagnostic and Prognostic Molecular and Imaging Biomarkers of Ocular Disorders Associated With Neurovascular Deregulation: Biocor Cohort

BIOCOR is an interventional clinical trial whose main objectives are Objectif are identify molecular biomarker(s) of ocular rosacea and pachychoroid. Endpoints are : Correlation between pachychoroidosis (defined by choroidal phenotype parameters in OCT and autofluorescence) or the stage of ocular rosacea (ROSCO(29) definition) and biological markers selected on the basis of preclinical work (animal model) and by unbiased methods (proteomics, metabolomics, meibum lipidomics). The study of circulating, ocular and functional biomarkers would enable us to confirm our hypothesis and identify patients who could benefit from treatments that regulate the ANS and/or mineralocorticoid pathways.


Eligibility Criteria:
Inclusion Criteria:

* Male or female \> 18 years of age, of European origin, with signed ± genetic consent
* Clear ocular media for OCT and autofluorescence imaging
* Signed consent form
* Be affiliated to a health insurance scheme
* Control patients are patients scheduled for cataract surgery or visual assessment.

Exclusion Criteria:

* High myopia \> 6D
* Diabetic retinopathy, hereditary retinal dystrophy, untreated retinal detachment, choroidal ocular tumor, choroidal hemangioma
* Epithelial or stromal keratopathy other than ocular rosacea
* Corneal surgery less than 3 months old, keratoplasty
* Deprived of liberty or under guardianship or curatorship
Evaluating a Preventive Heart Health Programme for Women at Midlife

This study examines the factors that limit or support the implementation of a pilot heart health program for perimenopausal women. The investigators evaluate the effectiveness of this program in raising awareness and promoting behavior change to maintain cardiovascular health.

Cardiovascular disease (CVD) is the leading cause of mortality among women. Heart-related conditions are responsible for the death of one out of every three women. In Singapore, CVD in women causes more morbidity and mortality than breast and cervical cancer. The burden will be exacerbated by Singapore's aging population and the longer life expectancy of women compared to men. Primary and secondary prevention strategies are implemented to reduce the overall impact of CVD on public health. Women who have traditional risk factors are at a greater risk of experiencing heart attacks compared to men with comparable risk factors. Additional risks specific to women include a history of pregnancy complications, breast cancer, and premature menopause. CVDs in women are frequently overlooked in terms of diagnosis and treatment.

Menopause is a phase in a woman's life that brings about significant changes to both her reproductive organs and her physical and psychological well-being. Management issues encompass a spectrum of concerns, including immediate symptoms like insomnia and palpitations, intermediate concerns related to bone health, and long-term considerations associated with the development of cardiovascular disease. The American Heart Association (AHA) provides guidelines for multidisciplinary care aimed at preventing cardiovascular disease (CVD) in women. Countries like Canada have established specialized organizations to address this issue. Collaborative clinics involving cardiologists, gynecologists, and women's heart centers are crucial, even for women who are generally healthy.

The objective of this study is to examine the factors that limit or support the implementation of a preventive heart health program for perimenopausal women. Additionally, the investigators aim to evaluate the effectiveness of our pilot women's health program in raising awareness and promoting behavior change to maintain cardiovascular health.

Eligibility Criteria:
Inclusion Criteria:

* Women aged 45-65 years at risk for cardiovascular disease or with pre-existing cardiovascular disease.
* English speaking

Exclusion Criteria:

* Pregnant women
* Unable to provide informed consent
* Women out of the menopause transition phase of 45-65 years of age.
Fertility-sparing in Early-stage Cervcial Cancer: The ETERNITY Project

The ETERNITY project is a retrospective analysis of outcomes of patients undergoing fertility-sparing treatment for cervcial cancer.

The primary aim is to report outcomes of those patients.

Other aims included:

1. Evaluation about the effectiveness of different treatment modalities;
2. Evaluation of outcomes according to different stages of disease;
3. Evaluation of the impactof neoadjuvant chemotherapy in patients undergoing conservative surgery


Eligibility Criteria:
Inclusion Criteria:

* Histological confirmed cervical cancer
* FIGO Stage IA1-IB3
* Fertility-sparing (conization plus nodal dissection)

Exclusion Criteria:

* age less than 18 yrs
* age more than 50 yrs