bioihbjkbjnl/mcl2 huggingface dataset:
A Clinical Study to Evaluate Ospemifene in the Treatment of Vulvar and Vaginal Atrophy in Postmenopausal Women
Condition: Atrophy; Vaginal Diseases
MeSH terms: Vaginal Diseases; Atrophy
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to determine whether ospemifene is more effective than placebo
      in the treatment of vulvar and vaginal atrophy (VVA) in postmenopausal women.
    


Intervention name(s): Ospemifene 30 mg; Ospemifene 60 mg; Placebo; Nonhormonal vaginal lubricant
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): 1 tablet (dose 30 mg/day) taken each morning with food for 12 weeks - from Visit 2 (Randomization, Day 1) to Visit 4 (Week 12).; 1 tablet (dose 60 mg/day) taken each morning with food for 12 weeks - from Visit 2 (Randomization, Day 1) to Visit 4 (Week 12).; 1 tablet taken each morning with food for 12 weeks - from Visit 2 (Randomization, Day 1) to Visit 4 (Week 12).; Subjects should apply the vaginal lubricant as needed and record the usage in the medication diary.
Other intervention name(s): K-Y® Brand Jelly
Intervention MeSH terms: Tamoxifen
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Urogenital atrophy; Vaginal atrophy; Vulvar and vaginal atrophy in postmenopausal women; Menopausal symptoms
Comparison of Two Medications Aimed at Slowing Aortic Root Enlargement in Individuals With Marfan Syndrome--Pediatric Heart Network
Condition: Marfan Syndrome
MeSH terms: Marfan Syndrome; Arachnodactyly; Syndrome
Study type: Interventional
Phase: Phase 3

Summary: 
      Marfan syndrome is a hereditary connective tissue disorder. Many individuals with this
      condition die because of the associated heart and blood vessel abnormalities. This study will
      compare the effectiveness of two medications, losartan and atenolol, at slowing aortic root
      enlargement in individuals with Marfan syndrome.
    

Detailed description: 
      Marfan syndrome is an inheritable disorder that affects the body's connective tissue. An
      abnormal protein results in connective tissue that is weaker than normal. Because connective
      tissue is found throughout the body, Marfan syndrome can affect many body systems, including
      the skeleton, eyes, nervous system, skin, lungs, heart, and blood vessels. Overall, heart and
      blood vessel abnormalities are the leading cause of death in individuals with Marfan
      syndrome. A common blood vessel abnormality associated with this disease involves the aorta,
      which is the large artery that carries blood away from the heart to the rest of the body. The
      aortic root, the portion of the aorta that is attached to the heart, may enlarge and tear or
      even rupture. A tear or rupture is considered a life-threatening emergency. Recent studies
      have shown that the medication losartan may reduce aortic root growth and improve heart
      function. The purpose of this study is to compare the effectiveness of losartan versus
      atenolol at slowing aortic root growth in individuals with Marfan syndrome.

      This 3-year study will enroll individuals with Marfan syndrome. Participants will be randomly
      assigned to receive either losartan or atenolol on a daily basis. All participants will
      initially receive a low dose of their assigned medication. This dose will be gradually
      increased every 3 to 4 weeks until the maximum tolerated dose is reached. A continuous
      electrocardiogram (ECG) that monitors heart rate and activity in 24-hour intervals will be
      used to determine the proper dose increase for each participant. Participants will then
      receive the maximum tolerated dose for the remainder of the study. Study visits will occur at
      baseline and Months 6, 12, 24, and 36. Each study visit will include a physical examination,
      a medical history review, an ECG, an echocardiogram, and questionnaires. Additionally, at the
      baseline study visit blood will be collected for laboratory testing.
    

Intervention name(s): Losartan Potassium; Atenolol
Intervention type(s): Drug; Drug
Intervention description(s): Losartan .3 - 1.4 mg/kg; Atenolol .5 - 4 mg/kg
Intervention MeSH terms: Losartan; Atenolol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Aortic Root Dissection; Aortic Root Dilation; Pediatric Heart Network
Changes in Adiponectin and Cardiovascular Disease Risk Factors in Overweight Patients
Condition: Exercise; Cardiac Myosins; Patients
Study type: Interventional
Phase: Phase 1

Summary: 
      This study aimed to determine if eight-weeks of exercise-based cardiac rehabilitation could
      improve adiponectin and cardiovascular disease risk factors in overweight coronary heart
      disease patients. Patients were included in the study if: they were approved to do so
      following a physical, physiological and psychological test; did not take part in regular
      physical activity; had stable heart failure for at least 3 months. Exclusion criteria
      included: a history of surgery within the preceding 4 months; had an unstable angina, acute
      phase of myocardial infarction, and/or unstable arrhythmia; had obstructive cardiomyopathy,
      exercise-induced ischemia or arrhythmias, uncontrolled arrhythmias, resting blood pressure
      more than 200/120 millimeters mercury, aortic stenosis, and/or peripheral artery disease;
      exercise limitations due to neuromuscular and/or musculoskeletal disease; had any health
      problems that prevented maximum effort on the treadmill test. Target population included of
      all patients with a history of myocardial infarction and diagnosis of congestive heart
      failure who were referred to Isfahan Cardiovascular Research Centre. 60overweight coronary
      heart disease patients were randomly assigned to either an eight-week, three times weekly
      exercise group (n=30), or a non-exercising control group (n=30). Exercise sessions took place
      at 60-85% of maximal heart rate, lasted 45-60 minutes and included a 10-minute warm-up, 40
      minutes of aerobic exercises, consisting of stationary cycling, walking and/or jogging,
      flexibility, balance exercises, and weight-bearing activity and a 10-minute cool-down.
    


Intervention name(s): Experimental; Control
Intervention type(s): Other; Other
Intervention description(s): Doing exercise at 60-85% of maximal heart rate, lasted 45-60 minutes and included a 10-minute warm-up, 40 minutes of aerobic exercises, consisting of stationary cycling, walking and/or jogging; They did not do ant exercise training during 8 weeks.
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Potential Predictive Biomarkers in Patients Undergoing First-line Chemotherapy for Metastatic Colorectal Cancer
Condition: Metastatic Colorectal Cancer; Chemotherapy Effect; Biomarker
MeSH terms: Colorectal Neoplasms
Study type: Observational

Summary: 
      Chemoresistance remains an obstacle in treating people with metastatic colorectal cancer
      (mCRC). Studying samples of blood and tumor tissue in the laboratory from patients with mCRC
      receiving chemotherapy may help doctors understand the effect of chemotherapy on biomarkers.
      It may also help doctors predict how patients will respond to treatment. In this study, we
      aimed to evaluate biomarkers in chemotherapy regimens for first-line chemotherapy for mCRC.
    


Intervention name(s): fluorouracil
Intervention type(s): Drug
Intervention description(s): chemotherapy treated patients
Other intervention name(s): capecitabine; irinotecan hydrochloride; leucovorin calcium; oxaliplatin; laboratory biomarker analysis
Intervention MeSH terms: Leucovorin; Capecitabine; Fluorouracil; Oxaliplatin; Irinotecan; Levoleucovorin
Observational model: Case-Only
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Histologically confirmed metastatic colorectal cancer
Evaluate the Association Between Infection and Thrombocytopenia
Condition: Thrombocytopenia
MeSH terms: Thrombocytopenia
Study type: Observational

Summary: 
      The study is designed to evaluate the association between nosocomial bloodstream infection
      and the occurrence of thrombocytopenia in surgical critical ill patients.
    


Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Sequential consenting adult patients of either sex were prospectively enrolled into the
        study.
Botswana Combination Prevention Project
Condition: HIV
Study type: Interventional
Phase: Phase 4

Summary: 
      The BCPP study is designed to test the hypothesis that implementing an enhanced combination
      prevention package which includes provision of ART to all participants, regardless of CD4
      count or HIV disease severity, will impact the HIV/AIDS epidemic by significantly reducing
      population-level, cumulative HIV incidence in a defined geographic area over a period of 3
      years and will be cost-effective.
    


Intervention name(s): Combination Prevention; Enhanced Care
Intervention type(s): Other; Other
Allocation: Randomized
Intervention model: Parallel Assignment
Primary purpose: Prevention
Effect of Dairy Consumption on Glycemic Control, Body Weight and Cardiovascular Risk in Patients With Type 2 Diabetes
Condition: Type 2 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2; Body Weight
Study type: Interventional

Summary: 
      This is a randomized prospective clinical study in patients with type 2 diabetes to evaluate
      the effect of dairy products with full or low fat on glycemic control and cardio-metabolic
      risk factors in comparison to a regular diet.
    

Detailed description: 
      This is a randomized, controlled clinical study in which 108 subjects with type 2 diabetes
      will be randomized into 3 different groups:

      Full fat dairy group (Group A): will receive nutritional counseling aiming to maintain body
      weight from a registered dietician and will be instructed to include at least ≥3 servings of
      full fat dairy products into their diet

      Low fat dairy group (Group B): will receive nutritional counseling aiming to maintain body
      weight from a registered dietician and will be instructed to include at least ≥3 servings of
      low fat dairy products into their diet

      Control group (Group C): will receive nutritional counseling aiming to maintain body weight
      from a registered dietician and will not be asked to include a specified amount or type of
      dairy products

      Subjects in Groups A and B will be educated about different dairy products' serving sizes and
      fat content. Subjects in all 3 groups will be asked to record their daily intake of dairy
      products in a dedicated log book. Subjects randomized to groups A and B will be asked to only
      use only dairy products with either the full fat or and low (≤1%) fat dairy (≤1% fat content)
      content respectively. Purchase of the dairy products will be the responsibility of study
      subjects for which a subsidy of $500 (about $20/week for 24 weeks) will be provided for each
      subject. All study participants will also be asked to record their food intake for 3 days
      before each study visit in a 3-day food log.
    

Intervention name(s): Full fat dairy; Low fat dairy; Control
Intervention type(s): Other; Other; Other
Intervention description(s): Participants will receive nutritional counseling aiming to maintain body weight from a registered dietician and will be instructed to include at least ≥3 servings of full fat dairy products into their diet; Participants will receive nutritional counseling aiming to maintain body weight from a registered dietician and will be instructed to include at least ≥3 servings of low fat dairy products into their diet; Participants will receive nutritional counseling aiming to maintain body weight from a registered dietician and will not be asked to include a specified amount or type of dairy products
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Drug Interactions From Simultaneous Administration Of Metformin And GSK189075 To Subjects With Type 2 Diabetes
Condition: Type 2 Diabetes Mellitus; Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      GSK189075 is intended for use as a single treatment or in combination with other treatments
      for tye 2 diabetes mellitus (T2DM). Metformin is widely used in Europe and the USA for the
      treatment of T2DM. This study will evaluate the effect of GSK189075 on metformin levels in
      the blood in T2DM subjects. The rationale is to look for any safety problems that may result
      when the 2 drugs are given together.
    


Intervention name(s): GSK189075 oral tablets; metformin tablets
Intervention type(s): Drug; Drug
Other intervention name(s): GSK189075 oral tablets
Intervention MeSH terms: Metformin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: GSK189074; T2DM; GSK189075; Glucophage; Obesity; Diabetes; Metformin; Type 2 Diabetes Mellitus; Drug Interaction
A Clinical Trial to Compare The Pharmacokinetics of A Pregabalin GLARS Tablet 150mg With Immediate Release Formulation and to Assess The Effect of High Fat Diet in Healthy Male Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this clinical trial is to compare the pharmacokinetic characteristics of
      GLA5PR GLARS tablet 150mg and Lyrica Capsule 75mg.

      GLA5PR GLARS tablet 150mg is a new once-a-day formulation which is made by GL Pharm Tech
      corporation.

      GLARS(Geometrically Long Absorption Regulated System) is new solution to sustained absorption
      by extending the absorption Site.

      To overcome the shortcomings of the currently existing sustained release drug delivery
      technologies the investigators have recently developed a novel drug delivery system to enable
      a drug to be dissolved irrespective of the surrounding environment and further absorbed up to
      colon. The investigators coined this "Geometrically Long Absorption Regulated System(GLARS)".
    

Detailed description: 
      Basically, this system is a triple-layered tablet, comprised of upper and lower layers that
      swell and draw a sufficient amount of water, plus a highly water - soluble middle layer that
      rapidly draw water into the tablet core simultaneously.

      The water drawn into the tablet (about 3 to 4 times the weight of the tablet itself)
      functions as an additional media which enables additional and later drug release out of the
      dosage form. This serves to overcome the shortage of surrounding media that has been reported
      to be one of the key reasons for malabsorption of a drug in colon.

      As the middle layer induces a rapid water draw into the tablet core, the penetrated water
      also diffuses to the upper and lower layers, which makes the tablet to rapidly swell and
      controls drug release.

      At virtually the same time, the swollen upper and lower layers form to surround a lateral
      side of the middle layer, which can, in turn, further control drug release.

      This relatively rigid swollen matrix structure makes drug release not affected by surrounding
      mechanical flux, which can provide relatively consistent in vivo drug release irrespective of
      degree of gastrointestinal motility.
    

Intervention name(s): Pregabalin; Pregabalin; Pregabalin
Intervention type(s): Drug; Drug; Drug
Intervention description(s): GLA5PR GLARS tablet 150mg/day(Pregabalin 150mg once a day, fasted); GLA5PR GLARS tablet 150mg/day(Pregabalin 150mg once a day, after high fat meal); Lyrica Capsule 150mg/day(Pregabalin 75mg twice a day, fasted)
Intervention MeSH terms: Pregabalin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Pregabalin; GLARS
MIYOPERİCYTOMA OF ORAL MUCOSE: CASE REPORT
Condition: Myopericytoma
MeSH terms: Myopericytoma
Study type: Observational

Summary: 
      Miyopericytoma (MPC) is defined as a benign tumor consisting mostly of oval-spindle-shaped
      myoid-appearing cells with perivascular growth. It may involve a single or multiple
      anatomical regions and may be multifocal and tends to occur mainly in the extremities, dermal
      and superficial soft tissues of adults. Cases of miyopericytoma due to trauma have been
      reported.Histological features and clinical course are generally benign, but features
      suggestive of low-grade malignancy were seen in MPCs. Myopericytoma in the oral and
      maxillofacial region is rare and a limited number of cases have been reported in the
      literature.

      A 42-year-old female patient was admitted to our clinic with an enlarging lesion on the
      lingual aspect of the anterior mandible, which she noticed 2 years ago. As a result of the
      examination, a smooth-surfaced, off-white, pedunculated, fibrotic, painless, and non-bleeding
      lesion was detected in the lingual aspect of the anterior mandible. The lesion was removed by
      excisional biopsy.
    


Intervention name(s): biopsy
Intervention type(s): Procedure
Intervention description(s): biopsy to identify the lesion in the oral mucosa
Observational model: Case-Control
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        1
      
Biospecimen description: 
      A sample was taken from the lingual region of the mandible for pathology.
    
Keywords: oral pathology; mıyopericytoma
Tracking Intervention Effects With Eye Tracking
Condition: Autism Spectrum Disorder
MeSH terms: Autism Spectrum Disorder
Study type: Interventional

Summary: 
      This pilot study examines concurrent and predictive relationships between eye tracking and
      clinical outcomes during a 16-week behavioral intervention (PRT) for children with ASD. Eye
      tracking will be comprised of both laboratory-based measures (using a commercial eye-tracking
      system) as well as home-based measures (using tablet-based eye tracking systems). The major
      goals of this study are both to improve our understanding of the potential role of eye
      tracking in clinical trials and to advance technologies that may further improve the
      sensitivity, robustness, accessibility, and ultimate utility of eye tracking methodologies.
    


Intervention name(s): Pivotal Response Treatment
Intervention type(s): Behavioral
Intervention description(s): Pivotal response treatment (PRT) is an empirically validated behavioral treatment for individuals with ASD that has its foundation in principles of Applied Behavioral Analysis. It was designed to improve social communication skills by addressing core deficits in social motivation or pivotal responses. By working specifically with each child's natural motivations, PRT focuses on naturalistic, functional skills, as opposed to rote skills. In this study, participants randomized to the PRT group will receive 6 hours of direct PRT, across three sessions per week, provided by Dr. Ventola's clinical team. Parents will have an additional one-hour session per week focused on PRT parent training using a practice-with-feedback model. Specific intervention goals in our target population include: Speech to respond to inquiries, Speech to inquire, Speech to comment, Reciprocal conversation, Monitor nonverbal information, and Perspective taking.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Supporting Adolescent Adherence in Vietnam (SAAV)
Condition: Adolescents; HIV/AIDS; Patient Adherence
MeSH terms: Acquired Immunodeficiency Syndrome; HIV Infections
Study type: Interventional

Summary: 
      The small RCT will assess feasibility, acceptability, and impact of a real-time intervention
      on ART adherence and clinical outcomes for HIV-positive adolescents. All subjects will use a
      wireless pill container (WPC) to monitor adherence. Intervention subjects will receive a
      personalized triggered reminder (cellphone message/call or bottle-based flash/alarm) when
      they miss a dose, and engage in monthly counseling sessions informed by their adherence data.
      Comparison subjects will receive usual care and an offer of counseling at monthly clinic
      visits.
    

Detailed description: 
      A major priority in HIV care and treatment is identifying effective interventions for
      adolescent patients, including those that make use of new technologies, to help them achieve
      and maintain high levels of adherence to antiretroviral treatment (ART), particularly as they
      take responsibility for their own medication-taking in the transition to adult care. The
      research planned here will contribute to the scientific evidence base on approaches to
      support ART adherence effectively among youth by 1) conducting formative research on
      adherence challenges among adolescents and refining options for a personalized adherence
      intervention package; and 2) implementing a small randomized controlled trial (RCT) to assess
      the feasibility, acceptability, and efficacy of a novel real-time feedback intervention that
      permits adolescent patients to tailor intervention features to suit their individual
      preferences.
    

Intervention name(s): Tailored realtime triggered reminder pkg
Intervention type(s): Combination Product
Intervention description(s): Core intervention: 1) real time, personalized wireless reminder messages when ART doses are not taken on time, and 2) 'feedback' on adherence behavior via monthly interactive counseling sessions informed by summaries of their previous month's behavior. Personalized features of the intervention will be selected by each patient and may include 1) reminders sent to the WPC (light or chimes) or to patient's or caregiver's cell phone if dose is late; 2) content of text messages from a menu of options; 3) use of "youth-friendly" WPC adherence reports for interactive counseling sessions; 4) additional counseling by clinic staff; 5) a "buddy" system, by choosing someone to review the adherence report with him/her; and 6) a "reward message" after a pre-selected time period of excellent adherence.
Other intervention name(s): wireless monitoring/feedback, counseling, dose histories
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: adherence; adolescent; HIV/AIDS; Vietnam
A Study to Compare Bioavailability of Naloxone Nasal Spray and Naloxone Hydrochloride (HCl) Intramuscular Injection (IM) in Healthy Volunteers
Condition: Healthy Volunteer
Study type: Interventional
Phase: Phase 1

Summary: 
      The main objective of this study is to compare early exposures of two test formulations of
      Naloxone Nasal Spray with the reference formulation of Naloxone HCl IM Injection under fasted
      conditions.
    


Intervention name(s): Treatment A: Naloxone Nasal Spray; Treatment B: Naloxone Nasal Spray; Treatment C: Naloxone HCL Intramuscular (IM) Injection
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Participants received naloxone nasal spray following a 10 hour fast.; Participants received naloxone nasal spray following a 10 hour fast.; Participants received naloxone HCl IM injection following a 10 hour fast.
Intervention MeSH terms: Naloxone
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment