cyrilzakka/clinical-trials huggingface dataset:
The Association Between Overweight and Oocyte Diameter in Women Undergoing Vitro Fertilization

We believe that there is an association between BMI and oocyte diameter in women undergoing IVF treatments. We plan to measure the oocyte diameter in 2 groups of women undergoing IVF. One group will have BMI 20-25 and the other group will have BMI above 30.


Eligibility Criteria:
Inclusion Criteria:

* IVF treated patients
* BMI between 20-25 or over 30

Exclusion Criteria:

* Everyone else
Telmisartan, Amlodipine and Combination in Healthy Subjects

To determine the pharmacokinetic profile of 80 mg telmisartan / 5 mg amlodipine (T80/A5) dose combination after single dose in healthy Chinese subjects.

To determine whether a pharmacokinetic interaction exists between telmisartan and amlodipine, following single doses of 80mg telmisartan (T80), and 5 mg amlodipine (A5) tablet alone and in combination, in healthy Chinese subjects.

To evaluate the safety and tolerability of T80 and A5 alone and in combination in healthy Chinese subjects.


Eligibility Criteria:
Inclusion criteria

1. Healthy males and females
2. Aged between 18 and 45 years
3. Body weight more than 50Kg , and Body Mass Index (BMI ) between 19 and 24 kg/m2

Exclusion criteria

1. Any finding of the medical examination deviating from normal and of clinical relevance
2. Any evidence of a clinically relevant concomitant disease
3. Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
4. Surgery of the gastrointestinal tract (except appendectomy)
5. Diseases of the central nervous system or psychiatric disorders or neurological disorders
6. History of relevant orthostatic hypotension, fainting spells or blackouts.
7. Chronic or relevant acute infections
8. History of relevant allergy/hypersensitivity (including allergy to drug or its excipients)
9. Intake of drugs with a long half-life (\> 24 hours) within at least one month or less than 10 half-lives of the respective drug prior to administration or during the trial
10. Use of drugs which might reasonably influence the results of the trial
11. Participation in another trial with an investigational drug within two months prior to administration or during the trial
12. Smoker
13. Inability to refrain from smoking during 24 hours prior to dosing and during the trial
14. Alcohol abuse or inability to stop alcoholic beverages for 24 hours prior to dosing and during the trial
15. Drug abuse
16. Blood donation (more than 100 mL within four weeks prior to administration or during the trial)
17. Excessive physical activities (within one week prior to administration or during the trial)
18. Any laboratory value outside the reference range that is of clinical relevance
19. Inability to comply with dietary regimen of trial site
20. A history of additional risk factors for torsade de pointes
21. Any history of relevant low blood pressure
22. Supine blood pressure at screening of systolic \<110 mm Hg and diastolic \< 60 mm Hg
23. History of urticaria
24. History of angioneurotic edema 25 Pregnancy / positive pregnancy test, or planning to become pregnant during the study or within 1 month of study completion

26. No adequate contraception during the study and until 1 month of study completion 27. Lactation period
A Non-Interventional Safety Study of Balsamic Bactrim

This is a pilot, observational and multicentric study of safety of sulfamethoxazole + trimethoprim + guaifenesin (Balsamic Bactrim) in adult participants with acute bronchitis. Adult participants with acute bronchitis eligible for treatment with Balsamic Bactrim will be enrolled. Administration of Balsamic Bactrim will be according to physician's recommendation under local labeling.


Eligibility Criteria:
Inclusion Criteria:

* Participants starting treatment with Balsamic Bactrim as per treating physician's discretion
* Participants with a clinical diagnosis of acute bronchitis (cough with or without sputum production less than 30 days) according to the treating physician's judgment

Exclusion Criteria:

* Participants who have started treatment with another antibiotic at the time of the visit
* Participants with no respiratory infections
* Participants with mental disorders that do not permit the clinical evaluation of the participant according to the treating physician's criteria
* Participants with severe hepatic parenchymal damage
* Participants with severe renal failure making it difficult to monitor drug plasma concentration
* Participants with hypersensitivity to any of Balsamic Bactrim active ingredients, excipients, and/or sulfas
A Research Program Targeting Pre- and Peri-transplant Optimization Program (R-PPOP)

The purpose of this study is to evaluate the feasibility and outcomes of a research pre- and peri-transplant optimization program (R-PPOP) to improve multiple domains of health including physical function, cognitive function, mental health, and diet and nutrition for patients planning to undergo or undergoing hematopoietic stem cell transplantation (HCT).


Eligibility Criteria:
Patient Inclusion Criteria:

* Plan to undergo an allogeneic hematopoietic stem cell transplant for any cancer or non-cancer illness within the next 6 months
* Age 18-80 years

Patient Exclusion Criteria:

* Both patient and caregiver are unable to read and follow directions in English (ok if only patient cannot read and follow directions in English as caregiver will be able to help).
* Any absolute contraindications to exercise:
* recent (\< 6 months) acute cardiac event;
* unstable angina;
* uncontrolled dysrhythmias causing symptoms or hemodynamic compromise;
* symptomatic aortic stenosis;
* uncontrolled symptomatic heart failure;
* acute pulmonary embolus;
* acute myocarditis or pericarditis;
* suspected or known dissecting aneurism; or
* coronary artery disease.
* Functional impairment resulting in inability to exercise

Caregiver inclusion criteria

* Identified by patient as their primary caregiver
* Age 18-80 years

Caregiver exclusion criteria

* None
Pharmacogenomics of Asparaginase Induced Hepatotoxicity

This pilot trial studies the impact of genetic information on developing liver damage caused by asparaginase in participants with newly diagnosed acute lymphoblastic leukemia. Testing saliva samples may help doctors find certain genetic markers that may predict whether participants will tolerate asparaginase, which is given as part of clinical care for acute lymphoblastic leukemia.

PRIMARY OBJECTIVES:

I. To establish the association between the SOD2 rs4880 genotypes and asparaginase-induced hepatotoxicity in Hispanic patients.

II. To identify novel single nucleotide polymorphisms (SNPs) that are associated with asparaginase induced hepatotoxicity.

OUTLINE:

Participants' SOD2 rs4880 SNP genotype (based on saliva from buccal swabs) will be classified. Participants with the CC genotype will be compared to participants with the CT or TT genotype. Buccal swabs of prospective participants' saliva will be collected when participant achieves complete remission (during regular clinical visit). Retrospective participants will be identified through search of pharmacy records for those who received asparaginase within the last 5 years (2012-2017). Recurrent patients will be consented during their regular clinical visits and samples will be collected.

Eligibility Criteria:
Inclusion Criteria:

* Newly diagnosed with acute lymphoblastic leukemia (ALL) - no prior treatment for ALL
* Receiving asparaginase as part of the primary treatment regimen
* Ability to understand and the willingness to sign a written informed consent
* For retrospective recruitment, those who have received asparaginase between 2012 and 2017; and are current patients of University of Southern California (USC)

Exclusion Criteria:

* Patients who are unable to give informed consent
A Study of Drug-Drug Interaction Between Darunavir and Danoprevir Administered Together With Low-Dose Ritonavir in Healthy Volunteers

This randomized, open-label, multiple-dose, 2-period crossover study will evaluate potential drug-drug interactions between darunavir and danoprevir when administered together with low-dose ritonavir in healthy volunteers. In Period 1, subjects will be randomized to receive either darunavir or danoprevir together with low-dose ritonavir for 10 days. In Period 2, all subjects will receive darunavir plus danoprevir together with ritonavir for 10 days. Anticipated time on study treatment is 20 days.


Eligibility Criteria:
Inclusion Criteria:

* Healthy non-smoking male and female adults, 18 - 55 years of age, inclusive
* Healthy status defined by absence of evidence of any active or chronic disease
* Medical history without major, recent, or ongoing pathology
* Weight \>/= 55 kg
* Body mass index (BMI) 18.0 - 32.0 kg/m2
* Ability and willingness to abstain from alcohol, xanthine-containing beverages or food (coffee, tea, cola, chocolate, "energy drinks") from 72 hours prior to entry in the clinical site center until discharge
* Females of child-bearing potential and males and their female partners of child-bearing potential must agree to use 2 forms of contraception, one of which must be a barrier method, during the study and for 90 days after the last drug administration. Acceptable barrier forms of contraception are condom and diaphragm; acceptable non-barrier forms of contraception for this study are non-hormonal intrauterine device (IUD) and/or spermicide

Exclusion Criteria:

* Pregnant or lactating females or males with female partners who are pregnant or lactating
* Any history of clinically significant cardiovascular or cerebrovascular disease, hypertension, and/or infections
* Positive test for drugs of abuse at screening or prior to admission to the clinical site during any study period
* Positive for hepatitis B, hepatitis C or HIV infection
* Current smokers or subjects who have discontinued smoking less than 6 months prior to first dose of study medication
* Use of hormonal contraceptives within 30 days before the first dose of study medication
* History of clinically significant drug-related allergy (such as anaphylaxis) or hepatotoxicity
Effects of Reduction in Saturated Fat on Cholesterol and Lipoproteins in Lean and Obese Persons

A randomized controlled clinical trial comparing the effect of substitution of unsaturated fat from nuts and oils for saturated fat from meat and dairy foods on serum lipids in normal weight and obese subjects with elevated LDL cholesterol.

Background: Increased intake of saturated fat may influence LDL cholesterol and other cardiovascular risk factors different in normal weight and obese subjects. Methods: The study is a randomized controlled clinical trial in 84 men and women between 21 to 70 years with normal BMI (25 kg/m2) or obesity (BMI 30-45 kg/m2) and elevated LDL cholesterol (\>3.0 mmol/l). Dietary intervention: Randomization will be to one of two balanced weight maintenance Mediterranean-type diets that differ in their fat sources: an intervention diet substituting unsaturated fats from oil and nuts for saturated fats from meat and dairy foods, and a control diet with whole fat dairy and meat with saturated fats that are not fat reduced.

Primary research question: Compare the effect of substitution of unsaturated fat from nuts and oils for saturated fat from meat and dairy foods on serum lipids in normal weight and obese subjects with elevated LDL cholesterol.

Secondary research questions: Compare the effect of substitution of unsaturated fat from nuts and oils for saturated fat on cardiometabolic risk factors including insulin resistance, inflammation and serum PCSK9 in normal weight and obese individuals.

Eligibility Criteria:
Inclusion Criteria:

* Men and women aged 21 to 70 years with normal BMI (25 kg/m2) or obesity (BMI 30-45 kg/m2) and elevated LDL cholesterol (\> 3.0 mmol/l).

Exclusion Criteria:

* Diabetes types 1 and 2
* History of CVD including myocardial infarction, percutaneous coronary intervention (PCI), coronary artery bypass grafting (CABG), stroke, transient ischemic attack (TIA) or other atherosclerotic disease, eating disorder and other secondary causes of hyperlipidemia.
* Use of statins or other cholesterol-modifying drugs.
* Genetic lipid disorder.
* Gastrointestinal disorders that limit food choices.
* Psychiatric illness, drug or alcohol abuse.
The Evaluation of the Deepithelialized Gingival Graft Healing

The aim of this study was to compare of the effects of different fixation methods on deepithelialized gingival graft wound healing. Laser doppler flowmetry method was used to determine for blood perfusion changes. 40 patients were devided into two groups randomly and deepithelialized gingival graft procedure was performed and healings were evaluated by laser doppler flowmetry.

This study evaluates the effects of different fixation methods on the early healing period of deepithelialized gingival grafts placed for non-root coverage gingival augmentation by laser Doppler flowmetry Forty patients were assigned to study groups: 1)test : tissue adhesive or 2) control group: suture. Forty patients completed the study. Blood perfusion in the recipient site was measured by laser doppler flowmetry on the day of surgery and at 3 and 7 days after surgery. Quality of life and pain at recipient sites were also investigated.

Eligibility Criteria:
Inclusion Criteria:

* 18 to 65 years of age
* systemically healthy
* inadequate amount or absence of keratinized gingiva on the labial side of the lower incisor region
* no restorations on the lower incisor region
* no mucogingival surgical history in the lower incisor region
* no periodontal treatment within the previous year
* no systemic antibiotics taken for 6 months before the study
* not pregnant or lactating
* no-smoking

Exclusion Criteria:

* lower 18 and upper than 65 years of age
* systemical disease
* adequate amount of keratinized gingiva on the labial side of the lower incisor region
* restorations on the lower incisor region
* mucogingival surgical history in the lower incisor region
* periodontal treatment within the previous year
* systemic antibiotics taken for ‡6months before the study
* pregnancy or lactating
* smoking history or current smokers
Effectiveness of SMS (Short Message Service) Text Messaging in Increasing Adherence to Gardasil

Human papillomavirus (HPV) is the most common sexually transmitted disease among adolescent females in the United States. Our primary objective is to determine if Short Message Service (SMS) text message reminders increase adherence to the recommended 3 dose schedule for Gardasil compared to usual care in an outpatient clinic setting. Secondary objectives of this study are: 1) to demonstrate the feasibility of using SMS text message reminders to increase adherence with Gardasil vaccination; and 2) to assess satisfaction and acceptability of text message reminders compared to telephone reminders among women who receive the text message arm of the intervention. The investigators hypothesize that receiving SMS text message reminders will increase adherence to the recommended 3 dose schedule for Gardasil compared to usual care.

Technological innovations such as Short Message Service (SMS) text messages reminders are one strategy that may be used to increase adherence to the Gardasil dosing schedule. Although the literature in this area is in its infancy, several studies have demonstrated that SMS text reminders are an effective strategy for reducing nonattendance with medical appointments. Further, SMS text message reminders have been shown to be popular with patients and more cost-effective than paper or telephone-based reminder strategies. The investigators believe SMS text message reminders can be used as a feasible and cost-effective strategy to increase adherence to the Gardasil vaccine schedule, thus reducing risk of cervical cancer.

Women who are enrolled will be randomly assigned to one of 2 study groups (Usual Care v. SMS Text Message group). For women in the SMS Text Message group, text message reminders will be sent once per day for each of the seven days prior to the scheduled date for each of their follow up vaccinations. Participants follow the usual practices for scheduling their follow up visit(s) for vaccination at the clinic. Participants in both the Usual Care group and the SMS Text Message group will receive the standard reminder from the clinic for their scheduled appointment(s) (phone call, letter, etc, as appropriate). At enrollment, the participant will answer questions regarding social and demographic history, cell phone use patterns, attitudes and acceptance of HPV vaccine, gynecologic and sexual history.

All participants will be sent a packet of self-report measures to complete regarding attitudes toward HPV vaccination at the completion of the study. Participants in the SMS Text Message group will also receive rating scales to assess acceptability of text message reminders and preference for text message reminders over telephone reminders.

Eligibility Criteria:
Inclusion Criteria:

* Have a mobile phone with text message capability
* Patient of University of Maryland Medical Center outpatient gynecology clinics
* Able to speak and read English
* Capable of understanding, consenting, and complying with the entire study protocol

Exclusion Criteria:

* Pregnant
* Previously completed the Gardasil vaccine
Radiotherapy for Thoracic and Breast Cancer and the Related Cardiotoxicity Following Treatment (RACCOON)

The purpose of this study is to investigate the risk factors and mechanisms of cardiotoxicity following thoracic radiotherapy and to provide insights in preventing radiation-related cardiotoxicity.

-Condition or disease : Thoracic irradiation -Intervention/treatment : Cardiac evaluation, Blood sampling

Cancer patients who undergo thoracic irradiation receive a certain amount of dose to the heart. Cardiotoxicity may occur in some patients several years after radiotherapy due to the late effect of radiation. Considering that cardiotoxicity is often lethal, screening and preventing radiation-induced cardiotoxicity is crucial in patients receiving thoracic irradiation.

Patients in this cohort will undergo cardiac evaluation before and after thoracic irradiation. The dose-volume parameters for each cardiac substructures will be estimated using artificial intelligence-based auto-segmentation of the heart in CT images. Dose-volume parameters that predict cardiotoxicity will be analyzed. Among the patients who developed cardiotoxicity, blood sampling will be performed to establish cardiomyocytes derived from induced pluripotent stem cells, which will be used for identifying the mechanisms of radiation-induced cardiotoxicity and therapeutic targets.

Eligibility Criteria:
Inclusion Criteria:

1. Patients with solid cancer who are subject to thoracic irradiation.
2. Patients who are 20 years old or older
3. Eastern Cooperative Oncology Group Performance Status Scale 0-2
4. Patients with cognitive abilities to receive virtual reality information

Exclusion Criteria:

1. Patients with a history of previous thoracic irradiation
2. Patients who refused consent
3. Patients with a history of heart failure before radiotherapy
Safety and Effectiveness of an Anti-HIV Drug Combination in HIV-Positive Patients Who Have Failed Previous Treatment With Protease Inhibitors

The purpose of this study is to see if it is safe and effective to give an anti-HIV drug combination containing indinavir and ritonavir to HIV-positive patients who have failed previous treatment with protease inhibitors.

Patients receive indinavir and ritonavir twice daily plus 2 NRTIs (NRTIs are not provided by this study). Physical examinations and laboratory tests, including plasma viral RNA levels and CD4 cell counts, are performed at Day 1 and Weeks 4, 8, 12, 16, 20, and 24 (or at discontinuation). The incidence of serious and drug-related adverse experiences is tabulated to determine drug safety. The proportion of patients achieving plasma viral RNA levels below 50 copies/ml (by UltraSensitive assay) are estimated statistically to determine drug efficacy.

Eligibility Criteria:
Inclusion Criteria

You may be eligible for this study if you:

* Are HIV-positive.
* Have a viral load (level of HIV in the blood) of 2500 copies/ml or greater within 45 days of study entry.
* Have a CD4 cell count of 100 cells/mm3 or greater within 45 days of study entry.
* Have been on an anti-HIV drug regimen containing a protease inhibitor for at least 16 weeks and initially did well on this treatment (your viral load decreased significantly) but later experienced treatment failure on this drug combination (your viral load increased significantly).
* Experienced treatment failure within 24 weeks of study entry.
* Are 18 years of age or older.
* Agree to use effective barrier methods of birth control (such as condoms) during the study.

Exclusion Criteria

You will not be eligible for this study if you:

* Are allergic to ritonavir or indinavir.
* Have hepatitis.
* Have an abnormal chest x-ray or abnormal liver function tests.
* Have taken 2 protease inhibitors at the same time for 7 or more days.
* Have taken non-nucleoside reverse transcriptase inhibitors (NNRTIs) in the 2 weeks before study entry.
* Have a medical condition that might make it unsafe for you to take the study drugs.
* Have experienced resistance to NRTIs and no new NRTI therapy is possible.
* Have taken certain medications.
* Abuse alcohol or drugs.
* Are pregnant or breast-feeding.
2-HOBA: Initial Evaluation in Humans

The purpose of this study is to evaluate the administration of single doses of 2-HOBA in humans, with an escalation of doses that begins with the calculated Maximum Recommended Starting Dose. This evaluation will assess tolerability to oral administration of 2-HOBA, obtain pharmacokinetic data, characterize the 2-HOBA metabolic pathways, and determine the relation of dose to prevention of formation of bi-functional electrophile adducts in blood. Characterization of the metabolic fate of 2-HOBA will be supported by investigations that evaluate metabolism in microsomes and cells.

Consenting volunteers of at least 18 years old with no morbidity, including males, and females who are not pregnant will be recruited for the study. A maximum of 28 volunteers may be enrolled with a reasonable sampling of ethnicities from the Nashville area, and an effort will be made to recruit equal numbers of males and females. Additionally, an effort will be made to study as old a population as possible and to recruit relatively similar age groups for males and females. All volunteers will be admitted to the Vanderbilt Clinical Research Center (CRC) as inpatients.

A complete health history and physical examination will be conducted by a physician. Volunteers will be asked to collect and bring their first morning voided urine for baseline urinalysis. An EKG, baseline blood analysis, vital signs, and questions about feelings and adverse events will be asked prior to supplement administration. All tests will be repeated at various intervals throughout the 24-hour study period. A physician will oversee all clinical aspects of the study and will be responsible for all trial-related medical decisions. Pharmacokinetics will be studied through the blood analyses at intervals throughout the study and 24-hour urine collection after administration of the supplement.

Eligibility Criteria:
Inclusion Criteria:

* Healthy individuals older than 18;
* Males and females who are not pregnant at the time of the study; and
* Not taking any medication 2 weeks prior to and during the study.

Exclusion Criteria:

* Inability to give informed consent;
* Diseases that could manifest symptoms or signs that would confound interpretation of the relation between drug action and potential adverse effects;
* Diseases that could manifest morbidity;
* Known cardiac disease, kidney disease, or hepatic dysfunction;
* The need to discontinue any drug that is administered as standard of care treatment; and
* Unwillingness or inability to use approved birth-control methods.