cyrilzakka/clinical-trials huggingface dataset:
A Study to Test How Different Doses of BI 3731579 Are Tolerated by Healthy People

The main objectives of this trial are to investigate safety, tolerability and pharmacokinetics and pharmacodynamics of BI 3731579 in healthy volunteers following administration of multiple rising doses per day over 15 days.


Eligibility Criteria:
Inclusion criteria

1. Healthy volunteers according to the assessment of the investigator, as based on a complete medical history including a physical examination, vital signs (blood pressure (BP), pulse rate (PR), respiratory rate (RR) and temperature), 12-lead electrocardiogram (ECG), and clinical laboratory tests
2. Age of 18 to 55 years (inclusive)
3. Body mass index (BMI) of 18.5 to 29.9 kg/m\^2 (inclusive)
4. Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission to the trial Further inclusion criteria apply.

Exclusion criteria

1. Any finding in the medical examination (including BP, PR, RR, temperature or ECG) deviating from normal and assessed as clinically relevant by the investigator
2. Repeated measurement of systolic blood pressure outside the range of 90 to 140 millimetre of mercury (mmHg), diastolic blood pressure outside the range of 50 to 90 mmHg, or resting pulse rate outside the range of 45 to 90 beats per minute (bpm)
3. Any laboratory value outside the reference range that the investigator considers to be of clinical relevance
4. Any evidence of a concomitant disease assessed as clinically relevant by the investigator Further exclusion criteria apply.
Effect of Nelutri™ on Musculoskeletal Biomarkers in Relative Sarcopenia Adults

The investigators conduct a randomized, double-blind, placebo-controlled study to investigate the effects of Nelutri™on muscle strength, muscle mass, and muscle function in healthy adults for 12 weeks.

A previous study has indicated that Nelutri™ may increase muscle mass and strength. Therefore, the investigators conduct a randomized, double-blind, placebo-controlled study to investigate the effects of Nelutri™on muscle strength, muscle mass, and muscle function in healthy adults; the safety of the compound are also evaluate. The Investigators examine the peak torque/body weight at 60°/s knee extension, handgrip strength, skeletal muscle mass, physical performance, and metabolic parameters at baseline, as well as after 6 and 12 weeks of intervention. Eighty adults were administered either 2,000 mg of Nelutri™ or a placebo each day for 12 weeks;

Eligibility Criteria:
Inclusion Criteria:

* \<110% of the standard lean body mass as measured using the body composition analyzer
* Body-mass index (BMI) ranging from 18.5 to 30.0 kg/m2
* Those who have an average protein intake of 60 g or more/day.

Exclusion Criteria:

* Abnormal liver or renal function (i.e., serum aminotransferase activity \> 60 IU/L and serum creatinine concentrations \> 1.2 mg/dL)
* Diabetes (diagnosed clinically or fasting glucose level \> 126 mg/dL)
* History of fracture during the previous year
* Uncontrolled hypertension
* History of serious cardiac disease such as angina or myocardial infarction
* History of gastrectomy
* History of medication for psychiatric disease
* Administration of oriental medicine including herbs within the past 4 weeks
* Evidence of relatively high skeletal mass (more than 110% of the standard lean body mass as measured using the body composition analyzer
Study of the Safety and Effectiveness of Rilonacept for the Prevention of Gout Flares

This was a clinical research study to determine the safety and effectiveness of an experimental drug called rilonacept in participants with gout who were beginning another additional treatment. Participants participated in this study for approximately 24 weeks. Rilonacept was being studied for use in preventing gout attacks in participants who had gout.


Eligibility Criteria:
Inclusion Criteria:

* Male or female greater than 18 years of age;
* Previously met the preliminary criteria of the American Rheumatism Association (ARA) for the classification of the acute arthritis of primary gout;
* At least 2 gout flares in the year prior to the screening visit.

Exclusion Criteria:

* Acute gout flare within 2 weeks of the screening visit and during screening;
* Persistent chronic or active infections;
* History of an allergic reaction to allopurinol;
* History or presence of cancer within 5 years of the screening visit.
Safety Profile Following Pentabio Vaccination in Indonesian Infants

To assess any serious systemic reaction within 30 minutes after Pentabio immunization

Any local and systemic reaction after Pentabio immunization

Eligibility Criteria:
Inclusion Criteria:

* Immunization with Pentabio vaccine
* Parents already understood the consequences to be involved in this study and having signed the informed consent form
* Parents agree and willing to fill in the Diary Card, to record all the reactions after immunization

Exclusion Criteria:

* Given simultaneously with other vaccines or with the interval less than 1 month with other vaccination except OPV/IPV.
Bortezomib (Velcade) Post Allogenic Peripheral Blood Stem Cell Transplantation for Myeloma

Primary Objective:

1. To determine the antimyeloma effect of bortezomib after allogeneic transplantation for patients with multiple myeloma.

Secondary Objective

1. To determine the toxicity profile of bortezomib in patients with multiple myeloma undergoing allogeneic progenitor cell transplantation.

Bortezomib (velcade) is a new drug that works by blocking a structure in the cells called proteasome. This proteasome acts like a system that eliminates abnormal or old proteins from the cells. Cancer cells may be sensitive to drugs like bortezomib (velcade), because tumor cells have more abnormal proteins than normal cells. Bortezomib (velcade) enters the tumor cells and affects the way they divide. When cancer cells cannot divide, they die.

You will have blood (about 2 tablespoons) and bone marrow testing done about every 2-3 months to determine your response and tolerance to treatment. To collect a bone marrow sample, an area of the hip or chest bone is numbed with anesthetic and a small amount of bone marrow is withdrawn through a large needle.

You will receive bortezomib (velcade) as an infusion into a vein over 5-10 minutes twice a week for 2 weeks. You will then rest for 10 to 17 days. This 21-28 day period makes up 1 cycle. You will complete up to a total of 4 cycles. Courses 2 and 3 might be given under supervision of your local physician however the principal investigator will do necessary treatment dose adjustments and new set of treatment orders will be provided to your physician. Treatment evaluations will be under the supervision of the principal investigator.

You will have a physical exam and routine blood tests (about 2 tablespoons) before each dose of bortezomib (velcade). Blood (about 2 tablespoons) and urine tests to determine response to treatment will be performed once a month, as well as blood tests to look at side effects of treatment, will be performed at least once a week and more frequently if medically necessary.

You will be taken off study if the disease gets worse or intolerable side effects occur. You will be called every 3 months for at least 1 year after the last dose of bortezomib (velcade) to see how you are doing.

This is an investigational study. Bortezomib (velcade) is commercially available and indicated for the treatment of myeloma. A total of 28 patients will participate in this study. All will be enrolled at M. D. Anderson.

Eligibility Criteria:
Inclusion Criteria:

* Patients with multiple myeloma at least 3 months post allogeneic transplant who either failed to achieve a complete remission or are relapsing.
* Allograft performed from a related donor who is HLA-compatible (5/6 or 6/6), or class I serologic match and class II molecular matched unrelated donor).
* Zubrod Points Scale (PS) \< 2, life expectancy is not severely limited by concomitant illness.
* Patient willing and able to sign informed consent.
* Patients less than 70 years of age.

Exclusion Criteria:

* Active Central Nervous System (CNS) disease.
* Uncontrolled acute or chronic Graft-versus-host disease (GVHD).
Pharmacokinetics, Safety, and Tolerability Study of the Pen and PFS of SB5 in Healthy Subjects

The purpose of this study is to compare the pharmacokinetics, safety, and tolerability of the pre-filled pen and pre-filled syringe of SB5 in healthy subjects.


Eligibility Criteria:
Inclusion Criteria:

* Healthy subjects
* Have a body mass index between 20.0 to 29.9 kg/m², inclusive.

Exclusion Criteria:

* History and/or current presence of clinical significant atopic allergy, hypersensitivity or allergic reactions, also including known or suspected clinically relevant drug hypersensitivity to any components of the test and reference investigational product formulation or comparable drugs
* Active or latent Tuberculosis or who have a history of Tuberculosis
* History of invasive systemic fungal infections or other opportunistic infections
* Systemic or local infection, a known risk for developing sepsis and/or known active inflammatory process
* Serious infection associated with hospitalisation and/or which required intravenous antibiotics
* History of and/or current cardiac disease
* Have received live vaccine(s) within 4 weeks prior to Screening or who will require live vaccine(s) between Screening and the subject's last visit
* Intake medication with a half-life \> 24 h within 4 weeks or 10 half-lives of the medication prior to investigational product administration
Randomized Controlled Trial to Evaluate of Dexmedetomidine for the Effect on Operative Visibility in Patients Undergoing Endoscopic Sinus Surgery

Various maneuvers are commonly used to achieve the ideal operative field necessary for successful endoscopic sinus surgery (ESS). Dexmedetomidine, a potent alpha2 adrenoceptor agonist which dose-dependently reduces arterial blood pressure and heart rate, decreases the hemodynamic and catecholamine response. And dexmedetomidine has an effect of peripheral vasoconstriction thus it is thus theologically appropriate for reducing bleeding during intranasal operation.

The aim of this study is to compare the effect of dexmedetomidine, an alpha2-adrenoreceptor agonist, on intraoperative bleeding, propofol requirement and postoperative profiles to remifentanil , an ultrashort-acting opioid.


Eligibility Criteria:
Inclusion Criteria:

* ASA Ⅰ-Ⅱ
* Aged between 20 and 70 year
* General anesthesia for endoscopic sinus surgery

Exclusion Criteria:

* Body mass index \>30
* Congestive heart failure, Sinus Bradycardia(\<50 BPM), Uncontrolled hypertension,
* Coagulopathy
* Drug addiction
* Pregnancy
* Allergic fungal infection
A Study To Observe Safety And Blood Concentrations Of PF-06412562 During And Following The Oral Administration Of Multiple Doses Of PF-06412562 In Healthy Adult Volunteers

This study is designed to evaluate the safety and plasma concentrations of PF-06412562 in healthy volunteers following three times daily oral dosing of PF-06412562 for 14 days


Eligibility Criteria:
Inclusion Criteria:

* Healthy female subjects of non-childbearing potential and/or male subjects between the ages of 18 and 55 years, inclusive (Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12-lead ECG and clinical laboratory tests).
* Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight \>50 kg (110 lbs);

Exclusion Criteria:

* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).
* Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study.
Serum Cholesterol Reduction Efficacy of Biscuit With Plant Stanol Ester

Efficacy of plant stanols as esters on LDL-cholesterol reduction is well documented. LDL-cholesterol lowering efficacy of the ingredient in a biscuit (providing 2 g plant stanols as esters per day) is less well known.


Eligibility Criteria:
Inclusion Criteria:

* mildly or elevated fasting serum cholesterol levels (between 5.2 to 6.5 mmol/l)
* fasting serum triglyceride levels below 3.0 mmol/l
* normal liver, kidney and thyroid function
* no lipid lowering medication
* no history of unstable coronary artery disease (myocardial infarction, coronary artery bypass craft (CABG), percutaneous transluminal coronary angioplasty (PTCA) within the previous 6 months, diabetes, temporal ischemic attack and malignant diseases

Exclusion Criteria:

* alcohol abuse (\> 4 portion/per day)
* pregnancy
* use of plant stanol and plant sterol products and equivalent cholesterol lowering products, though the ones who have discontinued the consumption of these products minimum 3 weeks before the beginning of the study, can be included
Incentives for Oklahoma Tobacco Helpline Engagement in Persistent Poverty Counties

The proposed pilot project is designed to evaluate the feasibility and potential efficacy of offering small financial incentives for the completion of smoking cessation counseling and self-reported abstinence at follow-up among Oklahoma Tobacco Helpline (OTH) callers living in persistent poverty counties (PPCs). The study will enroll at least 160 adults who reside in any of the 16 persistent poverty counties in Oklahoma, who are seeking smoking cessation treatment through the OTH.

The proposed randomized controlled trial will enroll adults who are seeking smoking cessation treatment through the OTH and who reside in any of the 16 PPCs in Oklahoma. Participants will be randomly assigned to OTH (coaching calls + nicotine replacement therapy) or OTH plus escalating financial incentives (OTH+FI) for completing up to 5 counseling calls over 8 weeks. Feasibility outcomes for the incentives-based intervention will focus on counseling call completions, follow-up assessment completion, smoking cessation, and incentive costs. Potential effectiveness will be evaluated based on comparisons of counseling call completions over the first 8 weeks post-enrollment and rates of self-reported smoking abstinence through 12 weeks post-enrollment (4 weeks after incentives have ended) in OTH+FI relative to OTH alone.

Eligibility Criteria:
Inclusion Criteria:

1. Contact the OTH seeking smoking cessation treatment
2. Reside in any of the 16 PPCs in Oklahoma (Adair, Caddo, Cherokee, Choctaw, Greer, Harmon, Haskell, Hughes, Johnston, McCurtain, Okfuskee, Payne, Pushmataha, Seminole, Sequoyah, Tillman)
3. Report smoking ≥ 5 cigarettes per day
4. Are ≥ 18 years of age
5. Are able to provide a copy/photo of their ID/driver's license or other documentation of identity and residence
6. Be able to read, speak, and understand English
7. Have no contradictions for NRT
Supervision Models in Training Environments

Attending physicians often supervise novice junior residents in a direct one-to-one format. Alternatively, a senior resident can be paired with a new trainee under the non-direct (but immediately available) supervision of an attending physician. Resident supervision has been considered an important step towards independent practice. Both models are ubiquitous in the United States, but no study to date has been performed if one model is better than the other with respect to supervision scores.

Supervision of residents is a cornerstone of ACGME accreditation and a critical focus of any training program. A nine-faceted, validated survey has been used to assess quality and effectiveness of supervision in training environments. Residents that assign poor scores for faculty members also tend to poorly evaluate the department-at-large. Further, residents that evaluate supervisors unfavorably also tend to report more patient safety mishaps in the context of a less safe work environment. Previous literature that used this supervision scale concluded that residents who reported mean department-wide supervision scores less than 3 (frequent) reported significantly more frequent occurrences of mistakes with negative consequences to patients and medication errors.

Attending physicians often supervise novice junior residents in a direct one-to-one format. Alternatively, a senior resident can be paired with a new trainee under the non-direct (but immediately available) supervision of an attending physician. Resident supervision has been considered an important step towards independent practice.. Both models are ubiquitous in the United States, but no study to date has been performed if one model is better than the other with respect to supervision scores.

Eligibility Criteria:
Inclusion Criteria:

* New incoming anesthesia residents assigned to healthy patients (ASA physical status classifications of 1 or 2).

Exclusion Criteria:

* New incoming anesthesia residents assigned to patients with ASA physical status classifications 3 or greater.
High-Flow Oxygen for Dyspnea in Hospitalized Cancer Patients

The goal of this clinical research study is to compare high-flow oxygen, low-flow oxygen, high-flow air, and low-flow air in helping to decrease shortness of breath in cancer patients. Researchers also want to learn if these therapies can help to improve lung function and quality of life.

Study Groups and Procedures:

If you agree to take part in this study, you will receive 4 different breathing therapies:

* High-flow oxygen
* Low-flow oxygen
* High-flow air and
* Low-flow air

The order in which they will be given to you will be randomly assigned (as in a roll of dice). You will have an equal chance of being assigned to each group. Neither you nor the study staff will know which therapy order you are assigned to. However, if needed for your safety, the study staff will be able to find out what you are receiving.

All 4 breathing therapies should take about 80 minutes total to complete (10 minutes for each treatment with a 10 minute break between each treatment). You will receive the air or oxygen through small tubes placed in your nose. The respiratory therapist will be there to adjust the therapy to your comfort level.

At the end of each breathing therapy, you will be asked about your shortness of breath and if you have any improvement. You will also be asked if you could tell whether you received oxygen or air after each therapy.

After finishing the 4 breathing therapies, you will complete 2 questionnaires about which breathing therapy you liked and your thoughts about taking part in the study. These should take about 10 minutes total to complete.

Length of Study:

You will be taken off study if you no longer wish to take part, or if you need drugs to help with shortness of breath during the study. Your participation in the study will be over after you complete the questionnaires.

This is an investigational study. Comparing high-flow air, low-flow air, high-flow oxygen, and low-flow oxygen to treat shortness of breath is considered investigational.

Up to 36 participants will be enrolled in this study. All will take part at MD Anderson.

Eligibility Criteria:
Inclusion Criteria:

1. Diagnosis of cancer
2. Patients seen by palliative care, thoracic oncology, pulmonary medicine, or emergency care at MD Anderson Cancer Center
3. Dyspnea Numeric Rating Scale at rest \>/=3 of 10 (average over last 24 hour)
4. Non-hypoxemic (i.e. oxygen saturation \>90% on ambient air)
5. Able to communicate in English or Spanish
6. Age \>/= 18 years
7. Able to tolerate high-flow oxygen/air

Exclusion Criteria:

1. Memorial Delirium Rating Scale \>13
2. Hemodynamic instability
3. Respiratory failure requiring mechanical ventilation or non-invasive ventilation
4. Frequent use of rescue opioids \>8x/day or rescue bronchodilators \>8x/day over last 24 hours
5. Currently requiring high flow oxygen for oxygenation
Characterizing HIV-related Diastolic Dysfunction

This is a multicenter clinical trial of a cross section of HIV+ patients with and without diastolic dysfunction. Approximately 200 HAART-treated virally suppressed HIV+ subjects (100 HIV+/DD+ \& 100 HIV+/DD-) will be enrolled. This study will evaluate biomarkers, phenomapping, metabolomics, cMRI, echocardiography to determine characteristics unique to this patient population.

With the advent of highly active antiretroviral therapy (HAART), human immuno¬deficiency virus (HIV) type 1 infection has become a chronic disease. The proportion of patients expected to survive 5, 10, and 15 years after conversion in the HAART era are 99%, 93% and 89% respectively. With increased life expectancy and decreased morbidity from opportunistic infections, the importance of chronic complications associated with HIV-1 infection, including HF is becoming more evident. The advent of HAART has altered the epidemiology of HIV associated cardiomyopathy evolving from a primarily left ventricular systolic dysfunction to the growing recognition of left ventricular DD. DD is associated with the development of atrial fibrillation and heart failure (HF), and portends higher risk for all-cause mortality. Thus there is a widespread prevalence of cardiac abnormalities in HIV infected individuals that are associated with HF development and may represent a sub-clinical abnormality that may be potentially intervened upon to reduce the risk of subsequent HF. There are little data to understand the natural history and pathogenesis of cardiac abnormalities, specifically DD in HIV+ individuals, which may adversely affect the longevity and quality of life of these individuals.

Eligibility Criteria:
Inclusion Criteria:

1. Age \>40 years
2. Willingness and ability to provide informed consent
3. HIV antibody positive
4. On HAART for \>6 months (HIV positive cohort only)
5. History of adequate viral suppression as defined by HIV RNA level \<200 copies/mL in the past 6 months
6. LVEF \>50% -

Exclusion Criteria:

1. Past EF \<50%
2. Moderate or severe valve stenosis or regurgitation, or past repair or replacement
3. Percutaneous or surgical revascularization or active angina
4. Persistent atrial fibrillation
5. BP\>160mmHg SBP or \>100mmHg DBP
6. Comorbid inflammatory disease (e.g. RA or SLE)
7. Active cancer or cancer chemotherapy treatment in the prior year (except skin cancer that did not require chemotherapy or radiation)
8. Chronic use of steroids or anti-inflammatory therapy
9. GFR \<30 mL/min
10. Active in a clinical trial with investigational product
11. Pregnant or lactating females
12. Contraindication to cMR or gadolinium injection (such as severe claustrophobia, metal implants, etc.)
A Woman Suffered From Leukocytopenia and Widespread Migration After Polyacrylamide Hydrogel (PAAG) Injection in Epicranial Aponeurosis

Polyacrylamide hydrogel (PAAG) has been used as an injectable filler for soft tissue augmentation in different parts of the body , such as face, breast , or even penis for more than a decade . However, there are never reports about the application of a large amount of PAAG in epicranial aponeurosis to change the contour of the upper cranium accompanied with leukocytopenia. This fancy application turned out to be a disaster for the women who suffered from leukocytopenia , widespread migration of PAAG, recurrent swelling of the affected tissues and temporal pain changing with the temperature and the facial expression .


Eligibility Criteria:
Inclusion Criteria:

* PAAG injected into bilateral temporal epicranial aponeurosis

Exclusion Criteria:

* PAAG injected into other parts of the body