cyrilzakka/clinical-trials huggingface dataset:
Proflaxis Using Hydroxychloroquine Plus Vitamins-Zinc During COVID-19 Pandemia

Healthcare professionals mainly doctors, nurses and their first degree relatives (spouse, father, mother, sister, brother, child) who have been started hydroxychloroquine(plaquenil) 200mg single dose repeated every three weeks plus vitaminC including zinc once a day were included in the study. Study has conducted on 20th of march. Main purpose of the study was to cover participants those who are facing or treating COVID19 infected patients in Ankara.

Healthcare professionals mainly doctors, nurses and their first degree relatives (spouse, father, mother, sister, brother, child) who have been started hydroxychloroquine(plaquenil) 200mg single dose repeated every three weeks plus vitaminC including zinc once a day were included in the study. Study has conducted on 20th of march. Main purpose of the study was to cover participants those who are facing or treating COVID19 infected patients.PArticipants, age, sex, BMI, smoking history, comorbid disease were also registered.

Eligibility Criteria:
Inclusion Criteria:

1. person who are working as health professional with contact to known COVID positive case
2. Their first degree relatives (child, spouse or parents)
3. must be able to swallow tablets

Exclusion Criteria:

1. Already using plaquenil for other reasons (RA etc)
2. person with the diagnosis of COVID infection
3. Person with the condition may cause complications with this medication (severe CVD, av block, already has ophtalmological complications, organ failure of any degree etc).
4. Documented allergic history to chloroquine;
5. Documented history of hematological system diseases;
6. Documented history of chronic liver and kidney diseases;
7. Documented history of cardiac arrhythmia or chronic heart diseases;
8. Documented history of retina or hearing dysfunction;
9. Documented history of mental illnesses; 10. Use of digitalis due to the previous disease.
Transfer Strategy in an Oocyte Donation Programme

It has been previously shown that although the activation of the embryonic genome can begin as early as two days of initiation of the embryonic development (D2), it is expressed on day 3 (D3). Without this activation, the embryo can not continue its development. Therefore, it has been suggested that extended culture to blastocyst stage could be an option to identify and better select embryos that have been able to carry out this activation. The purpose of this study is to compare cumulative pregnancy and live birth rates following transfer of cleavage embryos or blastocysts.


Eligibility Criteria:
Inclusion Criteria:

* Patients under their first or second cycle of a synchronous (fresh) oocyte donation cycle.

Exclusion Criteria:

* Preimplantation genetic screening or diagnosis cycles.
* Patients with strict blastocyst-stage embryo transfer indication by the couple's treating physician.
Qungasvik (Toolbox): Prevention of Alcohol/Suicide Risk in Alaska Native Youth

For the past 20+ years the investigators have focused on addressing two interrelated public health issues, alcohol use disorder (AUD) and suicide in Alaska. There is no greater source of health disparity in American Indian and Alaska Native (AI/AN) communities than that involving AUD and suicide, and no greater necessity in addressing this disparity than the development of sustained, trusting, collaborative, and non-exploitive research relationships with those who historically experienced forced acculturation and exploitation. Yup'ik community leaders have made addressing AUD and suicide among their highest priorities. Working with Yup'ik community members, the investigators developed a multilevel (individual, family, peer, and community) intervention that uses a culturally-based AUD and suicide prevention framework. The Qungasvik (kung-az-vik; a Yup'ik word meaning 'toolbox') intervention is a Yup'ik AN approach to prevention organized and implemented utilizing a local indigenous theory of change and process model to build protective factors against AUD and suicide. The purposes of the proposed research are to: (a) validate results obtained from previous smaller intervention studies aimed at reducing the incidence of AUD and suicide in 12-18 year old Yup'ik Alaska Native (AN) youth; and (b) learn more about the relative importance of the individual, family, peer, and community variables that underscore the Qungasvik intervention. This study will: (a) assess the efficacy of the Qungasvik intervention through a two group community level trial using an interrupted time series design with wait-listed control, and (b) examine mechanisms of change in response to intervention. Specific aims (SA) of the project are to: (SA1) test the Qungasvik intervention efficacy through impact on the ultimate outcome variables of reasons for life and reflective processes on alcohol use consequences, and on suicidal ideation and alcohol use; (SA2) examine the mechanisms of change in response to the Qungasvik intervention through (a) self-report outcome measures of protective factors (b) social network assessment and (c) process evaluation; (SA3) test levels of fidelity of the implementation of the intervention with regard to the Yup'ik indigenous theory-driven intervention model outlined in the Qungasvik manual of operations.


Eligibility Criteria:
Inclusion Criteria:

* Alaska Native youth 12-21 years

Exclusion Criteria:

* Children under the age of 12
Genetic Epidemiology of Coronary Heart Disease Risk in Women Twins

To examine genetic and environmental influences on several recently identified coronary heart disease risk factors in identical and fraternal adult women twins. The risk factors included low density lipoprotein (LDL) subclass patterns, plasma apolipoprotein levels, body fat distribution, and serum insulin levels.

BACKGROUND:

In 1974, a twin registry was established from members of the Kaiser Permanente Medical Care Program's Northern California region. In all, 9,821 twin pairs were enrolled. In 1978-1979, 434 pairs of female twins were recruited from the registry for a clinical examination of coronary heart disease risk factors. The clinical examination included an extensive health questionnaire, measurements of plasma lipids and serum chemistries, analyses of genetic markers for determination of zygosity, measurement of expired air carbon monoxide and serum thiocyanate levels, and a complete physical examination. During the ten years since the first examination, several new or more specific coronary heart disease risk factors have been recognized, including low density lipoprotein and insulin levels, and the anatomic distribution of body fat.

DESIGN NARRATIVE:

All women who participated in the first examination were invited to participate in the second examination. Medical records and/or death certificates were obtained to document coronary heart disease events. Questionnaires were used to collect information on health history, nutrition, and physical activity. A clinical examination assessed blood pressure, a variety of anthropometric measures and cardiovascular fitness. Blood specimens were collected for clinical chemistry and lipid/lipoprotein profiles. To assess genetic influence, the heritability of each of the risk factors was estimated. Blood was frozen for future studies of polymorphic DNA markers. Using the monozygotic co-twin control method, the effects of environmental or behavioral factors on these risk factors were assessed after controlling for genetic factors that could explain their association. Two hypotheses were examined that could be uniquely addressed using twin data. First, the association of body fat distribution with other coronary heart disease risk factors was mediated by serum insulin levels. Secondly, cardiovascular fitness explained in part the association of physical activity with coronary heart disease risk factors such as HDL-cholesterol and insulin levels. Lipoprotein analyses were conducted at Donner Laboratory at Berkeley.

The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.

Eligibility Criteria:
No eligibility criteria
Characteristics of Women With Reproductive Concerns

The purpose of this study is to collect data that will be generated during an office visit. The data will be gathered and analyzed in research studies that will help with the investigators understanding of various medical conditions.

About 200 subjects will be participating in this study. Participation in this study will not require a patient's time or presence. The medical information contained in a patient's chart from the office visit, including the results of any tests that were ordered at that time, will be transferred to an anonymous database and analyzed together with data from other patients who have similar condition/s.

No follow-up information will be collected. The following information will be collected from a patient's medical record: the medical history and a list of the current medications.

Purpose: To collect the characteristics of patients presenting to the reproductive endocrinology clinic.

Rationale: Patients' characteristics will be analyzed as part of clinical research studies and may help in understanding the causes of their condition.

Eligibility Criteria:
Inclusion Criteria:

* females of childbearing potential experiencing reproductive endocrinology related problems

Exclusion Criteria:

* male or female not of childbearing potential
Safety and Efficacy of Vaniprevir (MK-7009) With Pegylated Interferon (Peg-IFN) and Ribavirin (RBV) in Treatment-Experienced Hepatitis C Virus (HCV) Participants (MK-7009-009)

The purpose of this study is to test the safety, tolerability, and efficacy of 4 regimens of Vaniprevir + Peg-IFN and Ribavirin as compared to Placebo (PBO) + Peg-IFN/RBV. The primary hypotheses are that Vaniprevir is well tolerated, and that Vaniprevir 600 mg twice daily (b.i.d.) is superior to the control regimen for the percentage of non-cirrhotic (NC) participants achieving undetectable HCV ribonucleic acid (RNA) 24 weeks after the end of study therapy (SVR24).


Eligibility Criteria:
Inclusion criteria:

* Has chronic HCV genotype 1 infection
* Is treatment-experienced
* For the non-cirrhotic population, has had a liver biopsy without evidence of cirrhosis and hepatocellular carcinoma; for the cirrhotic population, has had a liver biopsy with evidence of cirrhosis and without evidence of hepatocellular carcinoma.

Exclusion criteria:

* Has not tolerated previous course peg-IFN and RBV
* Is unlikely to tolerate at least 24 weeks of continuous therapy with Peg-IFN and RBV
* Is co-infected with Human Immunodeficiency Virus (HIV) and/or hepatitis B
* Consumes excessive amounts of alcohol
* Has a history of drug or alcohol abuse
* If female, participant is pregnant or breastfeeding
* Has been in a clinical trail with an investigational drug in the last 30 days
* Has used IFN/Peg-IFN and RBV in the last 3 months
Effectiveness of Modified Class IV Atraumatic Restorative Treatment

Atraumatic Restorative Treatment (ART) has become an accepted dental restoration treatment in many developing countries. Because, ART is intended to be operated in molars, and about 10% of all carious lesion by an age of 18 years appear in anterior teeth in Gambia, it was the aim of this study to clinically evaluate a modified ART restoration technique for anterior teeth as the traditional treatment approach did not show satisfying clinical results.

Atraumatic Restorative Treatment (ART) has become an evidence-based treatment in class I caries cavities for countries with developing dental infrastructure. Though epidemiological data also demonstrate restorative treatment needs in anterior teeth in several African countries, scientific evidence for ART in this application appeared so far unrewarding. Consequently, many carious teeth remain untreated or are scheduled for extraction. In deciduous teeth, class III and IV ART presented 86% failures due to partial or complete loss already within the first year, and longitudinal data in the permanent dentition are rare. Survival rates of 71% after three years, and of 68% after six years in the same study cohort were reported from Brazil.

Basically, ART appears to be an interesting treatment approach as it combines a manual cavity preparation technique with the use of a glass-ionomer cement as an adhesive and fluoride releasing restoration material. Biomechanical stress, however, is above-average in class IV restorations when intending to reconstruct the incisal edge with glass-ionomer cement resulting in reported high rates of restoration fractures or loss. It was therefore the aim to evaluate the clinical effectiveness of a modified ART class IV restoration technique in a clinical study. These data are to be compared with an historical control (original ART class IV anatomical structure rebuilding restorations). Historical control data will be retrieved from "Jordan RA, Gaengler P, Markovic L, Zimmer S: Performance of Atraumatic Restorative Tratment (ART) depending on operator-experience. J Public Health Dent 2010; 70: 176-80."

Eligibility Criteria:
Inclusion Criteria:

* informed consent

Exclusion Criteria:

* no class IV cavity
A Study to Assess the Effect of Famotidine on the Drug Levels of Afimetoran in Healthy Participants

The purpose of this study is to confirm there is no significant effect of gastric pH changes of famotidine on the drug levels of afimetoran in healthy participants.


Eligibility Criteria:
Inclusion Criteria:

* Weight ≥ 50 kilograms (kg), at screening and first admission, and body mass index between 18.0 kilogram per square meter (kg/m\^2) and 32.0 kg/m\^2, inclusive, at screening.
* A negative QuantiFERON-TB Gold test result at screening or documentation of a negative result within 3 months before screening.
* Normal renal function at screening as evidenced by an estimated glomerular filtration rate (eGFR) ≥ 80 milliliter per minute (mL/min)/1.732 m\^2 calculated with the Chronic Kidney Disease Epidemiology Collaboration formula.

Exclusion Criteria:

* Any significant acute or chronic medical illness.
* Current or recent (within 3 months of study drug administration) gastrointestinal (GI) disease that could impact upon the absorption of study treatment.
* GI surgery, including cholecystectomy, that could impact upon the absorption of study treatment, at the investigator's discretion.
Parkinson's Disease and Digestive Health

This study focuses on the relationship between the brain and the gut, and additionally will foster collaboration between Movement Disorder experts and Neurogastroenterologists to provide critical information and lead to innovative therapies in the future to treat GI dysfunction of Parkinson's Disease.

Parkinson's disease affects 1 million people in the US with a rising prevalence. In addition to neurological problems, patients with Parkinson's Disease often suffer from debilitating gastrointestinal (GI) symptoms related to delayed stomach emptying, gas/bloating, and constipation. GI complaints of patients suffering from Parkinson's Disease are poorly understood. This proposal aims to characterize GI disturbance in patients with Parkinson's Disease and provide deeper understanding by investigating symptoms, regional and whole gut transit, anorectal physiology, and the brain-gut axis. The investigator believes patients with Parkinson's Disease will show altered GI sensation, slower GI motility and demonstrate deranged regulation of the brain-gut axis correlated to severity of Parkinson's disease. Results from this study of GI motility and brain-gut axis will define a subset of Parkinson's Disease patients that can benefit from tailored treatment. This study will foster collaboration between Movement Disorder experts and Neurogastroenterologists to provide critical information and lead to innovative therapies in the future to treat GI dysfunction of Parkinson's Disease.

Eligibility Criteria:
Inclusion Criteria:

* Presence of 2 of 3 cardinal features of PD (resting tremor, bradykinesia, and rigidity)
* Hoehn and Yahr Scale stage I-IV
* Men or women aged 18+
* Stable dopaminergic treatment for ≥4 weeks.
* Women of childbearing potential must agree to a urine pregnancy test at screening and to avoid pregnancy throughout the study.

Exclusion Criteria:

* Secondary parkinsonism.
* Parkinson-plus syndromes.
* Montreal Cognitive Assessment score \<17.
* Unstable dosage of drugs active in the cns (e.g., anxiolytics, antidepressants) during the 60 days before the visit.
* Participation in drug studies within 30 days of screening.
* Structural brain disease.
* Women who are pregnant or likely to conceive (women with potential for pregnancy must use contraceptive measures to be included);
* Active or personal history of epilepsy.
* Acute illness or active, confounding medical, neurologic, or musculoskeletal conditions.
* Alcoholism or other forms of drug addiction.
* Significant prior gastrointestinal surgery.
* Ongoing chemotherapy or other treatment for cancer.
* Dysphagia
* implanted or externally worn medical device such as, but not limited to, a pacemaker. (gastric stimulators, bladder stimulators, spinal stimulators, medication infusion devices, insulin pumps, continuous glucose monitors are permitted).
MgSO4 vs Metoclopramide for Headache in Pregnant Women

The study will compare effectiveness of intravenous magnesium sulfate to that of intravenous metoclopramide (Reglan®) for acute headache in pregnant women. We will randomize pregnant women who present to our emergency department with chief complaint of headache to magnesium sulfate 2 grams intravenously or metoclopramide 10 mg intravenously; both groups will receive acetaminophen (Tylenol®) 1 gram orally and normal saline 1 liter intravenously. Headaches are common during pregnancy, related to hormonal changes, altered sleep patterns and psychosocial stressors. Common medications for headache such as non-steroidal antiinflammatories or triptans are typically avoided during pregnancy due to concern for fetal effects. Women, and their physicians, are often uncertain regarding available medication options with justifiable safety profiles during pregnancy.

Metoclopramide and prochlorperazine (Compazine®), antiemetic dopamine receptor antagonists, are widely used for headache treatment in North American emergency departments. Metoclopramide, FDA pregnancy category B, is used in clinical practice for acute headache in pregnant women. Small studies have found magnesium sulfate to be effective in migraine, tension and cluster headaches, although there is no data regarding efficacy or tolerability in pregnant women.

Our study would be similar to a Turkish study published in 2004 which compared magnesium sulfate to metoclopramide for acute headache treatment in nonpregnant individuals; they found the drugs equally effective 30 minutes after administration. Serum magnesium levels in pregnant women are often lower than in nonpregnant women; magnesium deficiency has been explored as contributing to headache frequency and severity. Magnesium sulfate use has been well established during pregnancy for decades, administered intravenously to delay labor or to women with preeclampsia for 24 to 48 hours, initially with 4 to 6 gram bolus then 2 grams per hour. For headache treatment, magnesium sulfate dose would be far lower, 2 grams. We would like to determine the efficacy and tolerability of magnesium sulfate for headache relief in pregnant women, as well as evaluate efficacy of metoclopramide in pregnant women. We do not find published randomized trials evaluating headache treatment in pregnant women.

Eligibility Criteria:
Inclusion Criteria:

* Pregnant, 18-75
* Headache rated 4 or greater on a 0-10 pain scale

Exclusion Criteria:

* New objective neurologic abnormality at the time of exam
* Temperature \>100.4
* Allergy or intolerance to study medications
* Suspected of confirmed preeclampsia/eclampsia
* Complete heart block
* Hypotension, SBP\<85
* Myasthenia gravis
* End stage renal failure
Relative Bioavailability Study of HR19042 in Healthy Subjects

This is a single-center, randomized, open-label, three-period, dual Latin square crossover study.

Primary Objective：

1. To evaluate the oral relative bioavailability of HR19042 Capsules compared with budesonide delayed-release capsules (Tarpeyo®) and budesonide enteric-coated capsules (Budenofalk®).

   Secondary Objective
2. To assess safety following administration.


Eligibility Criteria:
Inclusion Criteria:

1. Male or female subjects, ages 18 to 45, inclusive, at the time of informed consent.
2. Female subjects weigh ≥ 45 kg, male subjects weigh ≥ 50 kg, and BMI between 19.0 and 28.0 kg/m2, inclusive, at screening.
3. Understands the study procedures in the informed consent form ICF and be willing and able to comply with the protocol.

Exclusion Criteria:

1. Subject with any history of severe allergic or anaphylactic reactions to any allergen including drugs, or allergic disease diagnosed and treated by a physician.
2. Clinically significant history or presence of respiratory, gastrointestinal, renal, hepatic, hematological, lymphatic, neurological, cardiovascular, psychiatric, musculoskeletal, genitourinary, immunological, dermatological, endocrine or connective tissue diseases or disorders
3. Subject has positive results at screening for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV), or treponema pallidum antibody.
4. History of any gastrointestinal surgery or cholecystectomy that could impact the PK of study drugs.
5. Participated in other clinical trials within 3 months before screening or plan to participate in other clinical trials during this study.
6. Blood loss or blood donation of more than 300 mL within 3 months before screening, or intended to donate blood during the trial.
7. Those who have been vaccinated with vaccines within 3 month before screening or who have an intention to vaccinate during the trial.
8. Difficulty in venous blood sampling or fear of needles/blood.
9. Difficulty in swallowing capsules, or inability to comply with the provided diet and study-related instructions.