cyrilzakka/clinical-trials huggingface dataset:
Bioequivalence Study of Montelukast 10 mg Tablets

The objective of this study was to confirm if two formulations of montelukast tablets are bioequivalent.

Test product was Montelukast (10 mg tablets; GlaxoSmithKline) and reference product Singulair (10 mg tablets; Merck Sharp \& Dohme). The single dosage was one tablet.

The study was prospective, open-label, randomized, crossover, single dose, with 02 treatments, 02 sequences and 02 periods, under fasting conditions.

The population was composed of 32 healthy volunteers, both genders, adults between 18-50 years.

The comparative bioavailability of the two formulations was evaluated based in statistical comparisons of relevant pharmacokinetic parameters, obtained from data of drug concentrations in blood.


Eligibility Criteria:
Inclusion Criteria:

Free will participation according to Mexican regulation, Helsinki Declaration, and Good Clinical Practice.

Healthy, between 18 and 50 years. Body Mass Index between 19 and 27 In good health by complete medical history and laboratory tests. Blood pressure 130-90/ 90-60 mm Hg; heart rate 55-100 beat per minute, respiratory rate 14-20 movements per minute.

Laboratory tests +/- 10% of normal interval (blood cytology, blood chemistry 27 elements, Hepatitis B and C antigens, HIV, urinalysis, anti-doping, pregnancy, electrocardiogram) -

Exclusion Criteria:

Alteration of vital signs Not complying with inclusion criteria History of cardiovascular, kidney, hepatic, muscular, metabolic, gastrointestinal (including constipation), neurologic, endocrine, hematopoietic (any kind of anemia), asthma, mental or organic disease. Those suffering from muscular trauma 21 days before the beginning of the study.

Requirement of any kind of medication during the course of the study, except study medication.

History of dyspepsia, gastritis, esophagitis, duodenal or gastric ulcer. Exposure to medications known as inducers or inhibitors of hepatic enzymes or administration of potentially toxic medication in the 30 days before the study beginning.

Administration of any medication in the 14 days or 5 half-lives (whatever longer) previous to the beginning of the study.

Hospitalization for any cause in the seven months before the beginning of the study.

Administration of investigational drugs in the 60 days before the study. Allergy to any antibiotics or non-steroidal anti-inflammatory analgesics. Alcohol ingestion or intake of beverages containing xanthines (coffee, tea, cocoa, chocolate, mate, cola drinks) or ingestion of charcoal grilled food or grapefruit or orange juice in the 72 hours before the hospitalization or tobacco smoking in the 72 hours before the beginning of the study.

Blood donation or loss =\> 450 ml in the 60 days before the beginning of the study.

History of drug or alcohol abuse. Special diet requirement, for instance vegetarian diet. Inability to understand nature, aims, and possible consequences of the study. Non-cooperative attitude during the study. Positive anti-doping or pregnancy test. Breast-feeding. Females on contraceptive hormonal treatment.

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Patient Preference Study in Type-2 Diabetes Mellitus: Discrete Choice Experiment (DCE) to Support Novo Nordisk's Long-Acting Insulin

The primary objective of this research is to assess T2DM patient preferences for a once weekly insulin treatment. The study involves a qualitative interview phase and quantitative survey phase with a Discrete Choice Experiment (DCE).


Eligibility Criteria:
Inclusion Criteria:

* Patient is an adult aged 18 years or over
* Patient was diagnosed with type-2 diabetes mellitus (T2DM) greater than or equal to 180 days prior to the day of screening
* Patient is currently prescribed a diabetes treatment (e.g., Metformin/Sus, DPP4i, SGLT2i, GLP-1 RA and/or basal insulin)
* Patient is willing and able to provide written informed consent to participate

For qualitative interviews:

* Patient is a fluent speaker of English and is able to read, write, and fully understand the English language
* Patient is a resident in Canada

For quantitative online survey:

* Patient is a fluent speaker of the local language (English/French/Spanish or Japanese) and is able to read, write and fully understand the local language
* Patient is a resident of either Canada, France, Spain or Japan

Exclusion Criteria:

* Patient is currently employing a basal-bolus insulin treatment regimen to manage their diabetes
* Patient is unwilling or unable to comply with the needs of the study or has a physical, behavioural or mental condition that, in the opinion of the recruiter may affect the patient's ability to take part in the study, understand the nature, scope and possible consequences of the study, or the responses they might provide.
Knee Isometric Program (KIP) Home Exercise Programs (HEP) Physical Therapy (PT) Study

The purpose of this study is to evaluate the efficacy of a knee isometric program (KIP) as compared to the current gold standard treatment for anterior knee pain (Patellofemoral Clinical Practice Guideline \[CPG\] - Academy of Orthopedic Physical Therapy).

Participants will be randomly allocated into the KIP or control intervention via spreadsheet randomization algorithm at the time of consenting. Each patient will have equivalent experiences for the duration of the study regardless of allocation. Time spent with the physical therapist, daily length of exercise program, outcome measures recorded, and home education materials will all be similar for each group. Participants will be asked to refrain from any outside forms of lower extremity strengthening or training. Usage of pain medication (including over-the-counter and prescription drugs) will be documented in the pain journal. Proper use of the pain journal will be explained during consent and again at the initial intake session.

Eligibility Criteria:
Inclusion Criteria:

* Accept all provisions of the study and agree to complete the program in its entirety
* Age between 18-65
* Complaint of anterior knee pain for at least 4 weeks, but no more than 12 months
* Prescribed referral for physical therapy for their knee(s) from one of the investigators

Exclusion Criteria:

* Potential participant does not agree to comply with study protocols or does not wish to be subjected to a random group allocation
* Any neurological or degenerative musculoskeletal condition involving the lower extremities
* Ages outside of 18-65
* Surgical history or fracture within the last 12 months on the affected extremity(ies)
* Currently participating in a structured strength training program
* Inability to access clinic for data collection or follow-up sessions
* Significant anatomical anomaly or limb alignment disorder as diagnosed by medical professional (femoral anteversion/retroversion, patella alta/baja, varus/valgus deformities, patella deformities/fractures, osteotomy procedures, limb lengthening procedures)
* Significant cartilage damage as diagnosed by medical professional (grade 3+ chondral defects of the femur or patella)
* Any other condition that limits full weight bearing of the affected lower extremity(ies)
* Vulnerable populations
The Effect of Reablement Service of Long-term Care on Physical Mobility and Quality of Life in Disable People

The long-term care 2.0 policy has been launched at 2017 by Taiwanese government to respond the rate of aging population reached to14% and estimated to 20% in 2025, becoming a "super-aged society" in Taiwan. As aging society, the ratio of chronic disease and disability has reasonably raised. The home reablement and care of this policy are not only to prevent and delay disability but provide daily care for the elderly who needed. As the implementation of the policy, there is still insufficient research to investigate and compare the effects on physical mobility and quality of life among the individual after using these different types of the service. Therefore, the aim of the study is to compare the effects on physical function and quality of life of the frail and disabled individual with and without receiving the home reablement services.

The participants will be enrolled from the long-term care service units registered in local government at Hualien county, Taiwan. The recruited participants will be assigned to two groups in a convenient method (receiving and non-receiving the home reablement service). All participants will be assessed by a professional physical therapist at three time points, before the reablement, at 1-3 months after receiving the reablement, then follow-up after 3 months


Eligibility Criteria:
Inclusion Criteria:

* Aged from 50-90 years old
* Be able to follow the command and cooperate with the assessor
* The disability grade level 2 to 8 according to the grading with long-term care case-mix system, approximately to 20 to 80 of Barthel Index score.
* Receiving the reablement services at least 3 times/a set.

Exclusion Criteria:

* Using the outpatient rehabilitation service during the study period
* Transferring or delivering to institution
* Re-admission to hospital during using the service
Study of MEDI-507 in With Steroid-Resistant Acute Graft-Versus-Host Disease

A clinical trial to assess safety and two regimens of (MEDI-507) a drug given to stem cell and bone marrow recipients who have a mid-grade acute Graft-versus-Host Disease.

To assess the safety of two regimens of MEDI-507 administered to stem cell and bone marrow allograft recipients who have at least grade II acute GVHD and who have not achieved a satisfactory response to at least three days of corticosteroid therapy (2 mg/kg/day of methylprednisolone or its equivalent).

Eligibility Criteria:
Inclusion Criteria:

* Allogeneic bone marrow or hematopoietic stem cell graft recipients
* Acute GVHD of at least grade II severity
* Failure of GVHD to improve on at least 2 mg/kg/day of methylprednisolone or prednisone for at least three days or recurrence of acute GVHD as corticosteroids are tapered from initial treatment of the initial episode of GVHD
* Evidence of engraftment (ANC over 1000 cells/mm3)
* Histologic evidence of GVHD from biopsy performed during the current episode
* Received GVHD prophylaxis of methotrexate, tacrolimus or cyclosporine
* Age at least 18 years
* Body weight under 130 kg
* Both males and females are eligible but females of childbearing potential will use an accepted method of avoiding pregnancy for at least 60 days after the end of treatment (which includes oral or implanted contraceptives, IUD, female condom, diaphragm with spermicide, cervical cap, abstinence, use of a condom by the sexual partner or a sterile sexual partner)

Exclusion Criteria:

* Previous receipt of MEDI-507
* Clinical or histologic manifestation of chronic GVHD
* Previous treatment with any anti-T-cell antibodies such as OKT®3 or daclizumab (Zenapax®)
* Receipt of antithymocyte globulin (ATGAM® or other ATG) since the day of transplant
* More than one allogeneic bone marrow or hematopoietic stem cell allograft
* Moribund and unlikely (in the opinion of the investigator) to survive 15 days
* Use of other investigational agents within 30 days (this does not include the use of licensed agents for indications not listed in the package insert)
* Any of the following clinical settings or diagnoses:

Ø documented or presumed significant active infection Ø pregnancy or nursing mother Ø evidence of infection with HIV-1, hepatitis B or C virus Ø hemodialysis or chronic peritoneal dialysis Ø use of a ventilator

* Histologically confirmed veno-occlusive disease of the liver
* Ascites on physical examination (this does not include small amounts of ascitic fluid detected only on ultrasound)
A Multi-centre Study to Assess the Long-term Performance of the Pinnacle™ Cup With a Polyethylene-on-metal Bearing in Primary Total Hip Replacement

The purpose of this study is to monitor the performance of the Pinnacle™ Cup with a polyethylene-on-metal bearing combination in the treatment of patients with hip joint disease requiring a total hip replacement. Patients who enter the study will be evaluated at regular intervals following hip surgery using patient, clinical and x-ray assessments.


Eligibility Criteria:
Inclusion Criteria:

i) Male or female subjects, aged between 18 and 70 years inclusive.

ii) Subjects who are able to give voluntary, written informed consent to participate in this investigation and from whom consent has been obtained.

iii) Subjects who, in the opinion of the Investigator, are able to understand this investigation, co-operate with the investigational procedures and are willing to return to the hospital for all the required post-operative follow-ups.

iv) Subjects undergoing primary total hip replacement who are suitable for a cementless acetabular component and a metal on polyethylene bearing.

Exclusion Criteria:

i) Subjects who, in the opinion of the Investigator, have an existing condition that would compromise their participation and follow-up in this study.

ii) Subjects undergoing revision hip replacement.

iii) Subjects undergoing simultaneous bilateral hip operation.

iv) Subjects with a contralateral hip replacement, which was implanted less than six months previously or is not performing satisfactorily.

v) Women who are pregnant.

vi) Subjects who are known drug or alcohol abusers or with psychological disorders that could affect follow-up care or treatment outcomes.

vii) Subjects who have participated in a clinical study with an investigational product in the last 12 months.

viii) Subjects who are currently involved in any injury litigation claims.
Circulatory Coherence in COVID-19 and Non-COVID-19 Patients With Sepsis

This prospective observational pilot study investigates circulatory coherence in patients with COVID and non-COVID sepsis by comparison of microcirculation, endothelial glycocalyx, and clinical course

This prospective observational pilot study investigates circulatory coherence in patients with COVID and non-COVID sepsis by comparison of microcirculation (sublingual area video recordings and biochemical parameters of endothelial cells activation and damage) endothelial glycocalyx (sublingual area video recordings and biochemical parameter of glycocalyx degradation), and clinical course.

Eligibility Criteria:
Inclusion Criteria:

* adult
* ICU admission due to sepsis with organ failure
* need for organ support therapy (mechanical ventilation, CRRT, ECMO)
* clinical and/or laboratory signs of circulatory instability

Exclusion Criteria:

* family withdrawal/disagreement
* death within three days from ICU admission
Shear-wave Elastography Compared to Respiratory Function Testing

The purpose of this study is to evaluate the relationship between transdiaphragmatic pressure (Pdi) and diaphragm shear-wave elastography (SWE) during state-of-the-art respiratory muscle testing including volitional efforts (e.g., maximal inspiratory pressure, maximal expiratory pressure, Valsalva maneuver), as well as maximal phrenic nerve stimulation.


Eligibility Criteria:
Inclusion Criteria:

- Adult male and female healthy volunteers.

Exclusion Criteria:

* Volunteers who are pregnant.
* Volunteers with known pulmonary pathology (COPD, asthma requiring routine treatment).
Gemcitabine, Oxaliplatin and Capecitabine for Advanced Pancreatic Carcinoma

Gemcitabine is the mainstay of palliative chemotherapy for patients with advanced pancreatic cancer (APC). Recent randomized trials have shown increased clinical benefit with the addition of oxaliplatin and prolonged median survival with the addition of capecitabine to gemcitabine. Gemcitabine, capecitabine and oxaliplatin are 3 newer, well tolerated anticancer drugs with mild and non-overlapping toxicity profiles. We therefore propose a dose-finding and safety study of the triple combination gemcitabine, capecitabine and oxaliplatin in patients with APC (Phase I part), followed by a phase II part to assess preliminary efficacy of this triple combination.

Primary Objectives:

* Phase I: to determine the maximum tolerated dose (MTD) of oxaliplatin in combination with gemcitabine and capecitabine (GEMOXEL) in patients with APC
* Phase II: to assess any anti-tumor activity of GEMOXEL in patients with APC

Secondary Objectives:

* to assess toxicity and safety of the combination treatment GEMOXEL in patients with APC

Primary Endpoints:

* Phase I: Dose-limiting toxicity
* Phase II: Objective tumor response

Secondary Endpoints:

* Toxicity at MTD according to NCI CTC 3.0
* Progression-free survival and Overall Survival

Eligibility Criteria:
Inclusion Criteria:

* Cytologically or histologically confirmed adenocarcinoma of the exocrine pancreas
* Disease non-resectable and locally advanced or metastatic
* Measurable disease or evaluable disease i.e. tumor marker CA19-9 at baseline ≥ 1.5 x upper limit of normal (ULN)
* Age \>18 years
* Karnofsky performance status ≥ 60%
* Life expectancy of at least 3 months
* Written informed consent
* Willing and able to comply with the protocol for the duration of the study

Exclusion Criteria:

* Prior chemotherapy for pancreatic cancer
* Prior adjuvant radio- or radiochemotherapy for pancreatic cancer within 12 months of inclusion
* Known CNS metastases at the time of enrollment
* Neutrophil count ≤ 1.5 x109/l, platelet count ≤100 x109/l, hemoglobin ≤ 10g/dl
* Serum creatinine \> 1.25 x ULN
* ASAT, ALAT and alkaline phosphatase \> 2.5 ULN or \> 5 ULN in the presence of liver metastasis, Bilirubin \> 1.5 ULN (after treatment of obstructive jaundice eg. stent)
* Pregnant or breast feeding women (women of childbearing potential must have a negative pregnancy test at baseline)
* Men and women of reproductive potential who are not using an effective method of contraception
* Clinically significant cardiac disease (NYHA III-IV) or myocardial infarction within the last 12 months
* Neurological disease with dys-/paraesthesias \> grade 1 according to NCI CTC
* Any serious concomitant disorder incompatible with the trial (in the judgement of the investigator)
* Psychiatric disability thought to be clinically significant in the opinion of the investigator precluding informed consent or interfering with compliance
Effect of HEPA Air Filters on Subclinical Markers of Cardiovascular Health

The purpose of this study is to evaluate the ability of portable high efficiency particle air (HEPA) filters to reduce exposures to PM2.5 and woodsmoke air pollution indoors and to improve subclinical indicators of microvascular function, systemic inflammation, and oxidative stress among healthy adult participants.

The investigators will use portable HEPA filters in a single-blind randomized crossover design. Each participant's home will be monitored for two consecutive seven-day periods, during which time two HEPA units (one in the bedroom and one in the main living room) will be operated indoors. During one 7-day period the HEPA filters will be operated normally, and during the other period the HEPA unit will be operated without the internal filter in place (i.e., "placebo filtration"), thus blinding participants to the filters' status. The order of filtration or non-filtration will be random. At the end of each 7-day period microvascular function will be assessed, blood will be collected for assessment of systemic inflammatory markers, and urine will be collected for assessment of oxidative stress markers.

Eligibility Criteria:
Inclusion Criteria:

* 19 years or older
* Non-smoking household
* Lives in study region (Smithers or Telkwa British Columbia)

Exclusion Criteria:

-
Switching From Morphine to Oral Methadone Plus Acetaminophen in the Treatment of Cancer Pain

The purpose of this study is to determine whether oral methadone plus acetaminophen can substitute morphine in the treatment of cancer pain.

Opioids are the mainstay of moderate-to-severe cancer pain management. Although morphine is the most commonly used, methadone has some advantages such as higher potency, lower cost and longer administration intervals. To minimize the time necessary to achieve the equianalgesic effect after a switching from morphine to methadone, acetaminophen was added in the treatment.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of cancer pain
* Regular use of oral Morphine

Exclusion Criteria:

* Use of Acetaminophen in the last 48 hours
* Renal or Hepatic failure
Effect of Strength Training on the Quality and Duration of Sleep and Daytime Sleepiness of Institutionalized Adolescents

The aim of this study was to analyze the effects of strength training on sleep quality and daytime sleepiness in institutionalized adolescents (14 to 19 years of age). Thirty-one adolescents were randomly assigned in two sample groups: intervention group (IG, n = 19) and control group (CG, n = 12). Anthropometric measures were performed (height and body mass) and BMI was determined. Sleep quality and daytime sleepiness were assessed using the questionnaires, Pittsburgh Sleep Quality Index (PSQI) and Epworth Sleepiness Scale (ESE), and total sleep time by accelerometer. Physical training (2x / week) was performed for 12 weeks. The OMNI Perceived Exertion Scale for Resistance Exercise (OMNI-RES) scale was used to control the effort intensity and the exercises followed an alternate pre-follow-up.


Eligibility Criteria:
Inclusion Criteria:

* Institutionalized adolescents (14 to 19 years of age)

Exclusion Criteria:

* refuse to participate,
* incomplete evaluation
Scripps Genomics Health Initiative

The specific aims for this project are to enroll up to 10,000 subjects who will have their genomes surveyed using the Navigenics™ Health Compass technology. The Navigenics Health Compass helps you understand what your genetic variants have to say about the future of your health, and gives you action steps to take control of your health today. In addition, the investigators will assess how the Navigenics Health Compass, results affect lifestyle decisions. The phenotyping information that can be analyzed with the resulting Navigenics genotype information will assist in identifying genetic variations associated with other traits and diseases.

The uses of molecular markers such as cholesterol and glucose levels to assess disease risk are well established in clinical medicine today. Although these tools are useful in screening for subclinical disease, their predictive value is limited. Until recently, these molecular markers were the best risk assessment and screening tools in existence. Since the completion of the Human Genome Project, the era of personalized medicine, which exploits knowledge of the genes an individual carries that may predispose him/her to disease, has come to the forefront of research.

The Navigenics Health Compass technology assesses risk for about over 20 common diseases and provides subjects with more accurate assessments of their individual predictive risk for developing these conditions than traditional biomarkers such as cholesterol and glucose levels. This may positively influence changes in lifestyle, as well as decisions to seek further medical evaluation associated with preventive strategies.


Eligibility Criteria:
Inclusion Criteria:

* Age 18 or older
* Able to read, write, and fluently understand English.
* Be reliable, cooperative, and willing to comply with all protocol specified procedures.
* Be able to understand and grant informed consent.
* Be able to provide payment for services rendered.
* Have an email address.

Exclusion Criteria:

* Intake of anything orally, i.e., food, beverage, cigarettes, brushing of teeth, 30 minutes prior to providing saliva sample.