cyrilzakka/clinical-trials huggingface dataset:
Multiple Rising Inhalative Doses of BI 1744 CL in Healthy Male Volunteers

Study to evaluate safety, tolerability, and pharmacokinetics of BI 1744 CL in healthy Japanese male volunteers.


Eligibility Criteria:
Inclusion Criteria:

* Healthy Japanese men: According to the results of a complete medical history, the physical examination, vital signs (blood pressure and pulse rate), 12-lead ECG, clinical laboratory tests
* Age ≥20 and ≤35 years
* Body mass index (BMI) ≥18.5 and ≤25.0 kg/m2
* Signed and dated written informed consent prior to admission to the study in accordance with Good Clinical Practice and the local legislation
* Subjects must be able to inhale medication in a competent manner from the Respimat®inhaler

Exclusion Criteria:

* Any finding of the medical examination (including ,blood pressure and pulse rate and ECG) deviating from normal and of clinical relevance
* Any evidence of a clinically relevant concomitant disease
* Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
* Surgery of the gastrointestinal tract (except appendectomy)
* Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders
* History of relevant orthostatic hypotension, fainting spells or blackouts
* Chronic or relevant acute infections
* History of relevant allergy/hypersensitivity (including allergy to drug or its excipients)
* 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 before drug administration or during the trial
* Use of prescription or non-prescription drugs within 10 days before drug administration or during the trial. However, over-the-counter drugs for external application (such as lubricant eye drops for contact lens, insect bite reliever) shall be allowed
* Participation in another trial with an investigational drug within four months before drug administration or during the trial
* Smoker (\>10 cigarettes or \>3 cigars or \>3 pipes/day)
* Inability to refrain from smoking on trial days
* Alcohol abuse (more than 60 g/day: corresponds to ca. 3 large bottles of beer, 3 gous (ca. 540 cc) of Japanese sake, 6 shots of whisky, 6 glasses of wine or 6 glasses of Japanese shochu, distilled alcoholic beverage)
* Drug abuse
* Blood donation (more than 100 mL within four weeks before drug administration or during the trial)
* Excessive physical activities (within one week before administration or during the trial)
* Any laboratory value outside the reference range that is of clinical relevance
* Inability to comply with dietary regimen of trial site
* A marked baseline prolongation of QT/QTc interval (e.g., repeated demonstration of a QTc interval \>450 ms) or long QT syndroms
* A history of additional risk factors for torsades de pointes (TdP) (e.g., heart failure, hypokalemia) or other cardiac arrhythmias
* hyperthyroidism
* Disagree with adequate contraception (the subject should use condoms and his partner should use oral contraception or intrauterine device \[IUD\]) during the study
A Continuation Study of the AeriSeal® System Administered at 3 to 4 Sites During a Single Treatment Session for Lung Volume Reduction in Patients With Advanced Emphysema

The purpose of this study is to assess the long term safety and efficacy of AeriSeal System treatment administered at up to 4 subsegments during a single treatment session for lung volume reduction in patients with advanced emphysema through 48 weeks after treatment.

Emphysema is a progressive, debilitating disease characterized by destruction of lung tissue as a result of inflammation caused by exposure to noxious inhaled agents for extended periods. The most common cause of this condition is cigarette smoking, although genetic, occupational, and environmental causes account for up to 10% of cases. Despite aggressive public health initiatives aimed at discouraging the use of cigarettes, smoking-related lung diseases remain a significant cause of disability and death worldwide. Due to the number of current and new smokers, emphysema is expected to remain a leading cause of morbidity and mortality for years to come.

The AeriSeal System is a novel device system being developed for the treatment of advanced emphysema. The AeriSeal System is administered bronchoscopically, and designed to provide the physiological benefits of lung volume reduction without the risks and cost of major surgery.

Eligibility Criteria:
Inclusion Criteria:

* Patients must have been enrolled in the 03-C10-002PLV Aeris' Investigational Study and completed a minimum of 12 weeks of follow-up following AeriSeal System treatment.
Effect of Antioxidant on Endurance Performance in Healthy Men

oligomerized litchi fruit extract may enhance the submaximal endurance exercise performance

Regular physical exercise has many beneficial effects, but it has been reported that strenuous exercise could elevate the production of free radical and other reactive oxygen species (ROS) which eventually injure the tissues and decrease the muscle function.So many kinds of antioxidant supplementations have been tried to decrease the muscle fatigue and enhance the exercise performance. polyphenolic flavonoids abundant in fruits and leafy vegetables have strong antioxidant effect. oligomerized litchi fruit extract has strong antioxidant capacity and higher bioavailability compared to that of grape seed polyphenol. The aim of this study was to determine whether oligomerized litchi fruit extract could induce endurance exercise performance more than Vit C + Vit E mixture or placebo could do. Therefore, we designed double blind randomized controlled trial, setting the change of running time to exhaustion under submaximal treadmill test as the primary endpoint.

Eligibility Criteria:
Inclusion Criteria:

* healthy men over 20 years old non-smoker

Exclusion Criteria:

* BMI\>25 or body fat\>25% he who intakes the antioxidant supplement in recent 2 weeks
Extension Study of Sotatercept in People With Pulmonary Hypertension (MK-7962-023)

Researchers are looking for new ways to treat people with a type of pulmonary hypertension called combined postcapillary and precapillary pulmonary hypertension (Cpc-PH). This study focuses on Cpc-PH that is caused by heart failure with preserved ejection fraction (HFpEF).

Researchers want to know if the study treatment, sotatercept, can treat people with Cpc-PH caused by HFpEF. This is an extension study, which means people who took part in a certain study on sotatercept for Cpc-PH (called a parent study) may be able to join this study. In this extension study, people will take sotatercept and researchers will follow their health for a longer time.

The main goal of this extension study is to learn about the long-term safety of sotatercept and if people tolerate it over a longer period of time.


Eligibility Criteria:
Inclusion Criteria:

The main inclusion criteria include but are not limited to the following:

- Completed MK-7962-007 (CADENCE) (Visit 9 and end of treatment \[EOT\] visit) without discontinuing study intervention and is able to safely enroll into MK-7962-007 (HARMONIZE)

Exclusion Criteria:

The main exclusion criteria include but are not limited to the following:

* Has a diagnosis of pulmonary hypertension (PH) in world health organization (WHO) Group 1, WHO Group 3, WHO Group 4, or WHO Group 5
* Has had a study intervention interruption
* Is pregnant or breastfeeding
* Has chronic liver disease with severe hepatic impairment and/or cirrhosis (eg, hepatic encephalopathy)
* Anticipation of more than 1 valve replacement or repair (mechanical or biomechanical) and/or have undergone more than 1 valve replacement or repair
* Has severe tricuspid regurgitation due to primary valvular disease (eg, from endocarditis, carcinoid, or mechanical destruction)
* Anticipated or undergone heart transplant or ventricular assist device implantation
* Has had prior exposure to luspatercept
RAPA-Keloid Study of Keloid Regression

1. To test whether topical rapamycin regresses established keloids in humans by measuring surface area and height changes in the scar over time (6 months)
2. To test safety of product and feasibility of conduct for future clinical trial

This pilot trial will use daily 0.5-1.0 ml applications of 8% RAPA (Rapamycin) in a petrolatum vehicle to treat established keloid lesions in 5 persons with at least 2 chronic keloids in similar body regions (greater than 1-year duration). Treatment will be applied once daily for 6 months. One keloid will receive 8% RAPA ointment and the other keloid will receive petrolatum-only ointment as a control. Surface areas and height of keloids will be monitored pre- and post-treatment to evaluate responses.

Keloid surface area and height changes will be measured pre-treatment and thereafter on a monthly basis using standardized digital photography with a tripod-mounted 8MP Canon S5is camera and calipers to measure keloid height (37).

Surface areas of all photographed lesions will be measured with Image J (http://rsbweb.nih.gov/ij/index.html), a public image-processing program that was used to analyze preliminary data and this study will use the same approach.

Eligibility Criteria:
Inclusion Criteria:

* Subject must have at least 2 keloid scars (for at least 1 year) in similar body locations that are easy to reach to apply ointment to
* Subject will be in good health with all chronic diseases (such as hypertension, coronary artery disease, etc.) clinically stable
* Cognitive functioning sufficient to provide informed consent
* Physically able to apply ointment to keloids daily
* Able to attend monthly clinic visits for 6 months

Exclusion Criteria:

* Diagnosis of diabetes
* Subjects taking the following medications: systemic steroid or immunosuppressant therapy within the past 6 months
* Local area steroidal treatment within the past 3 months
* History of allergy to rapamycin of petrolatum-based products
Effect of Melatonin and Metformin on Glycemic Control Genotoxicity and Cytotoxicity Markers in Patients With Prediabetes

Melatonin is a hormone that regulates the circadian cycle in addition to having an antioxidant effect. Patients with prediabetes state, has a deregulation of glucose metabolism and an overproduction of reactive oxygen species caused by levels of hyperglycemia that generate DNA modification in pancreatic beta cells, which leads to apoptosis and a deficient production of insulin. The administration of metformin and melatonin could be a possibility to treat and reverse the prediabetic state decreasing the glycemic levels and reactive oxygen species production.

A randomized, double blind, placebo-controlled, pilot clinical trial will carried out in 42 patients with a diagnosis of prediabetes, according to the American Diabetes Association criteria. The patients will be divide in three groups administrating metformin plus placebo, melatonin plus placebo or melatonin plus metformin. The intervention will be with 500 mg lengthed release tablets of metformin once a day in the morning, per 90 days, 5 mg lengthed release capsules of melatonin one a day in the night per 90 days and calcined magnesia as a placebo. Before and after the intervention, will be evaluate: fasting plasma glucose, blood glucose after an oral glucose tolerance test, A1c hemoglobin fraction, micronuclei frequency, nuclear anomalies frequency, insulin secretion and insulin sensitivity, weight, height, body mass index, triglycerides, total cholesterol, high-density lipoprotein, low-density lipoprotein, creatinine, uric acid, and sleep quality.

Eligibility Criteria:
Inclusion Criteria:

* Age beween 30 to 60 years old.
* Diagnosis of Prediabetes state according to the American Diabetes Association criteria.
* Without pharmacological treatment.
* Body mass index between 25 to 34.9 Kg/m2
* Sign informed consent

Exclusion Criteria:

* Patients with pharmacological treatment.
* Pregnant woman
* Patients with autoimmune, cancer, reumatic diases history or with pharmaceutical treatment
* Workers on night or changing shifts.
* Subjects that have been exposed to radiation
* Dyslipidemia: Total cholesterol \>250mg/dL, Triglycerides \>500 mg/dL.
* Subjects that have travel to other place with a different time zone.
* Patients with diagnosis of insomnia
* Patients with a glomerular filtration \<60 ml/min using the Cockroft-Gault Formula.
Assesment of the Implementation of a Therapeutic Educational Intervention Affecting Adherence to Oral Chemotherapy

Therapeutic education is an effective way to support the prescription of oral chemotherapy in oncology. It aims to increase adherence to treatment, to better control the side effects and reduce unplanned readmissions. The three major oncology institutions in the Rhône-Alpes region (Hospices Civils de Lyon, the Centre Léon Bérard Cancer Institute and Lucien Neuwirth) decided to collaborate on a project to implement an adapted Therapeutic Education Program context of each of these institutions.

The objective of this study is to evaluate the implementation of the intervention in the 3 participating centers, over 1 year:

1. Assess the achievement of the target population
2. Evaluate the adaptation of intervention in context
3. Evaluate the effectiveness of the intervention (impact): effectiveness in real life, identification of interactions with the environment linked to the center, identification of unintended effects of the intervention.
4. Assessing the sustainability of the intervention


Eligibility Criteria:
Inclusion Criteria:

* Patient care in medical oncology services of the Cancer Institute of Lucien Neuwirth, the Lyon-Sud hospital and the Centre Léon Bérard:
* Age over 18 years
* Introducing an active cancer (local extension, locoregional or metastatic)
* Oral chemotherapy as monotherapy or in combination with other treatments, initiated or in progress

Exclusion Criteria:

* Refusal to participate, protected adult patient under guardianship.
* Patient disability to understand the course of the study, the Therapeutic education program, or failure to follow the educational sessions.
* Patient with documented history of cognitive or psychiatric disorders.
* Patient on adjuvant therapy or hormone therapy for prostate cancer
Combined Oral Contraceptive (COC) Antiretroviral (ARV) Pharmacokinetics (PK) and Pharmacodynamics (PD) in Malawi

The purpose of this research study is to learn about the birth control pill called LoFemenal in HIV+ and HIV negative women who live in Malawi. This is a pilot study to determine the effect of antiretroviral therapy on the pharmacokinetics of the most commonly used oral contraceptive in HIV+ women; and to measure ovulation suppression in women taking the oral contraceptive pill and antiretroviral therapy at the same time. Nine women will be enrolled and will be followed for a total of 4 months.


Eligibility Criteria:
Inclusion Criteria:

* Can provide informed consent
* Women ages 21-35 with known HIV status
* If HIV negative must have had an HIV test within the last 3 months
* Intend to stay in Lilongwe region for the duration of the study
* Desire to prevent pregnancy for at least the next six months
* Desires to use LoFemenal for contraception
* Has no known history of infertility
* Has intact uterus and at least one ovary
* Has regular monthly menses defined by menses occurring every 21-35 days
* Has not used another form of systemic hormonal contraception within the last six months.
* Has no contraindications to the combined oral contraceptive LoFemenal which include; any thrombophlebitis or thromboembolic disorders; cerebral-vascular or coronary-artery disease (current or history); thrombogenic valvulopathies; thrombogenic rhythm disorders; major surgery with prolonged immobilization; diabetes with vascular involvement; headaches with focal neurological symptoms; uncontrolled hypertension; known or suspected carcinoma of the breast or personal history of breast cancer; carcinoma of the endometrium or other known or suspected estrogen dependent neoplasia; undiagnosed abnormal genital bleeding; cholestatic jaundice of pregnancy or jaundice with prior pill use; hepatic adenomas or carcinomas or active lever disease, as long as liver function has not returned to normal; known or suspected pregnancy.

Exclusion Criteria:

* Hemoglobin \< 10 mg/dL.
* Body mass index \< 18.6 kg/m\^2.
* Using any drugs known to interfere with cytochrome P450 system (such as rifampicin, phenytoin, carbamezapine, among others)
* In the opinion of the PI or study staff the individual cannot complete the study
* Cannot be adherent to other medications.

Additional inclusion criteria for the 3 HIV+ women on antiretroviral therapy:

* Must be on antiretroviral therapy which includes nevirapine for at least three consecutive months immediately prior to enrollment into the study
* Must report adherence to medication and medical visits
* Must be willing to use a barrier or backup method of contraception.
QUILT-2.014: Gemcitabine and AMG 479 in Metastatic Adenocarcinoma of the Pancreas

AMG 479 is an investigational fully human monoclonal antibody that targets type 1 insulin-like growth factor receptor (IGF-1R). Signaling through IGF-1R plays an important role in the regulation of cell growth and survival. The primary purpose of the study is to determine if AMG 479 and gemcitabine improves overall survival as compared to placebo and gemcitabine.


Eligibility Criteria:
Inclusion Criteria:

* Untreated metastatic adenocarcinoma of the pancreas
* Adequate hematologic, renal and liver function
* Eastern Cooperative Oncology Group (ECOG) 0 or 1

Exclusion Criteria:

* Prior chemotherapy or radiotherapy for pancreatic cancer
* Central nervous system metastases
* External biliary drain
Indomethacin Prior to Difficult Embryo Transfer is it a Solution?

IVF/ICSI patients who had difficult mock embryo transfer on the day of ovum pick up. Will be randomly assigned into two groups; group A will receive 100mg indomethacin rectal suppository 1-2 hours before ET and group B will not receive indomethacin


Eligibility Criteria:
Inclusion Criteria:

* Infertile patients undergoing IVF cycle with difficult mock embryo transfer
* Early follicular FSH level ≤10 IU/L.
* Tubal, male infertility and unexplained causes of fertility will be recruited.
* Fresh ET.

Exclusion Criteria:

* Repeated IVF failure.
* Past history of allergy to NSAID, bronchial asthma , peptic ulcer or inflammatory bowel disease.

  * Easy mock embryo transfer.
Alternate Day Buprenorphine Administration, Phase XII - 17

The purpose of this study is to determine if six times daily buprenorphine dose is effective in achieving 120 hour buprenorphine dosing.


Eligibility Criteria:
Please contact site for information.
Abdominal Muscle Thickness in Mechanically Ventilated Patients

The purpose of the study is to determine to what extent the abdominal muscles contribute to airway pressure, in order to investigate the correlation between muscles weakness and extubation outcome in mechanically ventilated patients. In addition the reliability of the sonographic measurements will be assessed.

The purpose of the study is to determine to what extent the abdominal muscles contribute to airway pressure, in order to investigate the correlation between muscles weakness and extubation outcome in mechanically ventilated patients. In addition the reliability of the sonographic measurements will be assessed.

Eligibility Criteria:
Inclusion Criteria:

* greater than 18 years old
* Patients requiring invasive mechanical ventilation including patients with endotracheal tube and tracheotomies

Exclusion Criteria:

* Patients with a previously diagnosed neuromuscular disorder (acute or chronic)
* Behavioural agitation
* Patients who are not awake and cooperative
* Previously enrolled in the study
Erlotinib in Patients With Resected, Early Stage NSCLC With Confirmed Mutations in the EGFR

In this research study erlotinib will be given to eligible participants whose lung cancer has been removed by surgery. Eligible patients have adenocarcinoma, a type of non-small lung cancer, and must have 1 or more of the following characteristics: be female, be of Asian or Pacific Rim descent and/or be a never smoker. The potential participant's tumor will be examined for Epidermal growth factor (EGFR) mutations. EGFR is a protein that is overexpressed in most non-small cell lung cancers. Some EGFR has been found to have specific mutations and the participant must have one of these mutations in his tumor.

Erlotinib blocks this protein and may control tumor growth and increase survival. Previous research has shown that erlotinib is most effective for people who have these specific mutations in the EGFR.

* Erlotinib is a pill taken daily and participants may continue to receive erlotinib for up to two years, as long as the cancer does not return and they do not experience any unacceptable side effects.
* While participants are receiving erlotinib, they will be asked to return to the clinic for study visits to monitor the status of their disease and their general health. For the first 5 months of erlotinib, they will return to the clinic monthly. After that they will return to the clinic every three months.

Eligibility Criteria:
Inclusion Criteria:

* Pathologically confirmed diagnosis of NSCLC of adenocarcinoma histology
* Stage IA-B, IIA-B, or IIIA by the American Joint Committee on Cancer 7th edition staging criteria
* Patients must have undergone surgical resection with curative intent within 6 months of enrollment
* Sufficient tumor tissue available for EGFR mutation analysis
* At least ONE of the following patient characteristics: previously detected deletion 19 or L858R EGFR mutation, female sex, history of never smoking, or Asian/Pacific Rim ethnicity (to be enrolled in the screening portion of trial).
* 18 years of age or older
* Tumor samples must have either exon 19 deletion mutations or the exon 21 L858R point mutation
* ECOG Performance status of 0,1, or 2
* Adequate organ function as outlined in protocol

Exclusion Criteria:

* Radiographic evidence of recurrent NSCLC prior to erlotinib treatment
* Confirmed T790M resistance mutation in the primary tumor sample
* Prior exposure to EGFR tyrosine kinase inhibitors
* Known hypersensitivity to erlotinib, gefitinib, or any closely related drug
* Pregnant or breastfeeding women
* Any evidence of clinically active interstitial lung disease
* Current use of enzyme-inducing anti-epileptic drugs, including carbamazepine, oxcarbazepine, phenytoin, fosphenytoin, phenobarbital, and primidone
* Evidence of any other significant clinical disorder or laboratory finding that makes it undesirable for the patient to participate in the study
* Use of any non-FDA approved or investigational agent within 2 weeks of enrolling onto the trial, or failure to recover from the side effects of any of these agents
Effects of Core Stability Exercises With and Without Treadmill Training on Balance in Children With Down Syndrome

To find the effects of core stability exercises with and without treadmill training on balance in children with down syndrome


Eligibility Criteria:
Inclusion Criteria:

* able to stand and walk independently
* able to understand and follow a verbal command
* cutoff score less than 6 or 7 in functional balance in indicated

Exclusion Criteria:

* patients have any neurological issue,
* Instability of atlantoaxial joint
* Vision and hearing loss
* History of fall