bioihbjkbjnl/mcl2 huggingface dataset:
The Effect of Rifapentine on Raltegravir
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The aim of this study is to study the effect of rifapentine on plasma concentrations of
      raltegravir.
    

Detailed description: 
      Primary Objective

      To compare the pharmacokinetics parameter values (geometric mean Cmin and AUC) of raltegravir
      at 400 mg q12h alone to raltegravir at 400 mg q12h co-administered in combination with
      rifapentine 900 mg once weekly, and to raltegravir at 400 mg q12h co-administered in
      combination with rifapentine 600 mg per day, 5 days per week.

      Secondary Objective

      To assess the tolerability and safety of concomitant administration of raltegravir and
      rifapentine in healthy volunteers.

      Design

      This study is a three-period, one-sequence, open label, pharmacokinetic study of the
      raltegravir-rifapentine interactions in healthy, male and female volunteers. Up to 21
      subjects may be enrolled to achieve the estimated sample size of 16 completing subjects. All
      study medication will be self-administered except on the days of pharmacokinetic sampling.
      All subjects will participate in three sampling periods and be studied in a day clinic or be
      admitted overnight to a hospital.
    

Intervention name(s): Raltegravir and rifapentine
Intervention type(s): Drug
Intervention description(s): Period 1- Raltegravir 400 mg q12h by mouth for 4 days
Period 2- Rifapentine 900 mg taken by mouth once per week for 3 doses and raltegravir 400 mg q12h by mouth for 4 days
Period 3- Rifapentine 600 mg taken by mouth once daily for 5 of 7 days per week for 10 doses and raltegravir 400 mg q12h by mouth for 4 days
Other intervention name(s): Isentress - Raltegravir; Priftin - Rifapentine
Intervention MeSH terms: Raltegravir Potassium; Rifapentine; Rifampin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Keywords: Raltegravir; Pharmacokinetics; Rifapentine; Drug Kinetics
The Efficacy of Mutaflor(E. Coli Nissle 1917, Mutaflor®) for Chronic Constipation:Multicenter Study
Condition: Constipation
MeSH terms: Constipation
Study type: Interventional
Phase: Phase 4

Summary: 
      Chronic constipation is a prevalent, burdensome gastrointestinal disorder whose treatment
      remains challenging. There exist effective pharmacological therapies for chronic
      constipation, however, many patients do not well respond to current medications. Evidence
      suggests that disturbance in the gastrointestinal microbiota may be implicated in chronic
      constipation. Although, E.coli Nissle 1917 (Mutaflor®) has been used for chronic
      constipation, there are limited data regarding the efficacy of E.coli Nissle 1917 (Mutaflor®)
      in these patients. Therefore, this study aimed to investigate the efficacy of E.coli Nissle
      1917 (Mutaflor®) in patients with chronic constipation.
    


Intervention name(s): E. coli Nissle 1917(Mutaflor®); Placebo
Intervention type(s): Drug; Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Intracervical Block Versus Placebo to Assess Pain Control During Hysterosalpingogram
Condition: Infertility
MeSH terms: Infertility
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to compare the efficacy of 1% lidocaine intracervical block to
      placebo for pain control during the performance of a hysterosalpingogram (HSG). We
      hypothesized that an intracervical block would decrease pain during a hysterosalpingogram.
    

Detailed description: 
      The hysterosalpingogram (HSG) is an integral part of the evaluation for anatomic etiologies
      of female infertility. The majority of women regard a hysterosalpingogram as acutely painful
      since it involves placement of a cervical tenaculum, traction on the cervix, and instillation
      of dye through a cervical cannula. Different techniques have been employed to attempt to make
      the procedure less painful, including use of balloon catheters rather than cannulas; however,
      this has not been shown to be uniformly effective. Previous studies have shown a reduction in
      overall pain during HSG after pre-medication with oral non-steroidal anti-inflammatory drugs.
      Benzocaine gel (20%) applied to the cervix has also been shown to reduce pain. Conversely, a
      study of pre-medication with paracetamol (acetaminophen) showed no statistical improvement in
      pain perception. Additionally, transcervical intrauterine instillation of lidocaine has been
      shown in randomized studies to not improve pain scores and may actually increase pain after
      the procedure is complete A MEDLINE literature search of papers written in English from
      January 1966 to August 2005, using the keywords "hysterosalpingogram," "analgesia",
      "paracervical," and "intracervical" did not reveal any prior studies on the use of an
      intracervical block prior to hysterosalpingography. A paracervical block has been shown to
      decrease pain with therapeutic abortions, endometrial biopsy, and office hysteroscopy (7, 8).
      We hypothesized that an intracervical block would also decrease pain during a
      hysterosalpingogram. A three armed, randomized controlled trial comparing pain control after
      a 1% lidocaine intracervical block, saline injection or no injection in patients undergoing
      hysterosalpingogram was performed.
    

Intervention name(s): 1% Lidocaine intracervical injection
Intervention type(s): Drug
Intervention MeSH terms: Lidocaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: hysterosalpingogram; intracervical local anesthesia; pain perception; visual analogue scale
Tamoxifen Versus Anastrozole, Alone or in Combination With Zoledronic Acid
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional
Phase: Phase 3

Summary: 
      The primary objective is, first, the comparison of tamoxifen and anastrozole and, second, the
      comparison of zoledronate added to standard adjuvant therapy with controls according to
      disease-free survival (DFS) in premenopausal patients with non-metastatic breast cancer
      treated with tamoxifen or anastrozole. To assess whether zoledronate added to standard
      adjuvant therapy can decrease or even prevent bone loss in patients treated with hormonal
      blockade combined with an antiestrogen or aromatase inhibitor.
    

Detailed description: 
      The trial is conducted as an open multi-center phase III study, in a two-factorial study
      design and according to Good Clinical Practice (GCP) guidelines. Patients will be randomly
      assigned to a total of 4 study groups in a 1:1:1:1 assignment ratio. Several stratification
      criteria will be used in order to ensure balanced distribution of known risk factors.

      A total of 1.803 patients will be enrolled in 4 arms. Patients will either be treated with
      anastrozole (1mg daily for 3 years) or tamoxifen (20mg daily for 3 years), and will
      additionally receive either zoledronate (8mg q4 weeks for 3 years) or no zoledronate (arm A:
      Nolvadex alone; arm B: Nolvadex plus zoledronate; arm C: Arimidex alone; arm D: Arimidex plus
      zoledronate).

      Zoledronate will be administered by i.v. injection at a dose of 4 mg/month for the treatment
      period of 3 years. Five Bone Mineral Density (BMD) measurements will be performed in a
      subgroup of patients (404 patients, enrolled in 3 centres).
    

Intervention name(s): tamoxifen; anastrozole; zoledronic acid; goserelin
Intervention type(s): Drug; Drug; Drug; Other
Intervention description(s): 20 mg/d; 1 mg/d; 4 mg q6m; 3.6 mg goserelin subcutaneously every 28 days
Other intervention name(s): Nolvadex; Arimidex; Zoledronate, Zometa
Intervention MeSH terms: Tamoxifen; Zoledronic Acid; Anastrozole; Goserelin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Austrian Breast & Colorectal Cancer Study Group (ABCSG); 12; Phase 3; breast cancer; anastrozole; tamoxifen; zoledronic acid; premenopausal; hormone receptor-positive; Stage I; Stage II; bone mineral density; BMD; bisphosphonate; zoledronate
Phase I Safety and Immunogenicity Vaccine Trial Against HIV/AIDS
Condition: HIV Infections
MeSH terms: HIV Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      The development of a vaccine against HIV/AIDS has been primary focused on the structural
      proteins (Env, Gag) of HIV-1 with the aim of inducing sterilizing immunity by blocking virus
      entry. Alternative approaches are focused on new vaccine strategies aimed at modifying the
      virus-host dynamic favouring the establishment of a long-term non-progressing disease status.
      Such strategies target regulatory proteins that are the first to be expressed after infection
      and are essential for viral replication, infectivity and pathogenesis. Thus, this approach
      may be effective for both preventive and therapeutic vaccination strategies.
    

Detailed description: 
      Being a very early viral regulatory protein necessary for viral gene expression, cell-to-cell
      virus transmission and disease progression, Tat represents a key target protein for the host
      immune response and an optimal candidate for such a vaccination strategy.

      Preclinical studies demonstrated that vaccination with a biologically active Tat protein is
      safe, elicits a broad and specific immune response and induces a long-term protection against
      infection. Cross-sectional and longitudinal studies in natural infection suggest that the
      presence of an anti-Tat humoral immune response correlates with asymptomatic infection and
      with a slower disease progression while the presence of CD8+ T cell responses to Tat
      correlate with early virus control both in humans and monkeys. Since the immunogenic regions
      of Tat are well conserved among the HIV-1 M group, a vaccine based on Tat may be used in
      different geographic areas of the world.

      This Phase I study was directed at evaluating the safety profile (as a primary end-point) and
      the immunogenicity (as a secondary end-point) of the recombinant HIV-1 Tat vaccine in HIV-1
      infected adult volunteers with mild immune deficiency (Clinical category A according to CDC),
      CD4+ T cell counts 400/mL and levels of plasma viremia < 50,000 copies/mL.

      Study Design: Randomized, Double Blind, Placebo Controlled, Safety/Immunogenicity Study.
    

Intervention name(s): recombinant HIV-1 Tat protein
Intervention type(s): Biological
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: HIV; Tat protein; HIV Therapeutic Vaccine
Epidemiology of Carotid IMT Progression in MESA - Ancillary Study
Condition: Atherosclerosis; Cardiovascular Diseases; Heart Diseases; Carotid Artery Diseases; Coronary Arteriosclerosis
MeSH terms: Carotid Artery Diseases; Cardiovascular Diseases; Heart Diseases; Atherosclerosis; Arteriosclerosis; Coronary Artery Disease; Myocardial Ischemia
Study type: Observational

Summary: 
      To determine the factors associated with progression of sub-clinical atherosclerosis and to
      evaluate the associations between the progression of sub-clinical atherosclerosis and the
      development of clinically manifest atherosclerosis.
    

Detailed description: 
      BACKGROUND:

      Cardiovascular disease remains the leading cause of death in the United States and one of the
      leading causes of morbidity. New technology recently has allowed the non-invasive
      investigation of the extent of atherosclerosis in different vascular beds. Unfortunately, the
      clinical implications and significance of this new technology have not yet been fully
      examined nor has the interrelationship between these various measurements of clinical and
      sub-clinical atherosclerosis. The study is ancillary to the Multi-Ethnic Study of
      Atherosclerosis (MESA), an NHLBI-supported epidemiological study of atherosclerosis in
      several ethnic groups.

      DESIGN NARRATIVE:

      A longitudinal assessment of the carotid intima media thickness (IMT) will be added to the
      scheduled follow-up visits in MESA subjects in order to study the relationship between
      carotid IMT and a measure of calcium burden in the coronary vessels. In addition, studies
      will be conducted on how these two non-invasive markers of atherosclerosis relate to
      cardiovascular disease risk factors and clinical events.The study will utilize the MESA
      cohort involving 6500 subjects who will have baseline and four follow-up examinations.
      coronary artery calcification (CAC) and IMT are being obtained at baseline, with CAC
      determinations also scheduled at follow-up. IMT determinations will be added in conjunction
      with the CAC studies in the second and third exams and detailed analyses will be carried out
      on these two measures of atherosclerotic burden that may reflect different biologic
      processes.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Participants of the Multi-Ethnic Study of Atherosclerosis, a cross-sectional NIH population
        cohort originating from 6 regions in the United States
Comparison of Absorption of Vitamin D in Cystic Fibrosis
Condition: Cystic Fibrosis
MeSH terms: Cystic Fibrosis; Fibrosis
Study type: Interventional
Phase: Phase 4

Summary: 
      The investigators predict that a powder pill form of vitamin D will be more effectively
      absorbed than an oil form of vitamin D in people diagnosed with Cystic Fibrosis.
    

Detailed description: 
      The purpose of this study is to see how well two different forms of vitamin D work in Cystic
      Fibrosis (CF). Patients with Cystic Fibrosis have a hard time absorbing certain foods and
      often have low vitamin D levels. Studies show that vitamin D may help fight infections common
      in Cystic Fibrosis. The investigators would like to see if a powder pill form of vitamin D
      will work better than a pill mixed with oil. Each person will randomly receive either a
      powder pill or an oil based pill. Blood will be tested while during a 3-4 day hospital stay.
      The investigators plan to enroll no more than 24 patients with CF from Emory University
      Hospital for this study.
    

Intervention name(s): Vitamin D Powder; Vitamin D Oil
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Patients will be randomly assigned to a powder supplement of 100,000 IU vitamin D3. Randomization will be in blocks of 4 (meaning for every 4 subjects there will be 2 vitamin D and 2 placebo treated patients). Blood will be drawn by IV catheter at baseline, 2, 4, 8, 12, 24, 48, and 72 hours after vitamin D3 dosing; Patients will be randomly assigned to an oil based supplement of 100,000 IU vitamin D3. Randomization will be in blocks of 4 (meaning for every 4 subjects there will be 2 vitamin D and 2 placebo treated patients). Blood will be drawn by IV catheter at baseline, 2, 4, 8, 12, 24, 48, and 72 hours after vitamin D3 dosing
Other intervention name(s): D3-50 Cholecalciferol; Maximum D3
Intervention MeSH terms: Vitamin D; Ergocalciferols; Cholecalciferol; Vitamins
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Cystic Fibrosis; Vitamin D; absorption; vitamin Deficiency; fat soluble
A Study to Compare Pharmacokinetics and Pharmacodynamics of RinGlar® to Lantus® in Type 1 Diabetes Mellitus Patients
Condition: Clamp Study
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional

Summary: 
      Pharmacokinetics and pharmacodynamics study of 2 formulation of insulin glargine (RinGlar®
      GEROPHARM vers. Lantus® Sanofi-Aventis)
    

Detailed description: 
      A randomized double blinded two-way crossover single-dose pharmacokinetics and
      pharmacodynamics study of RinGlar® (LLC "GEROPHARM", Russia) versus Lantus® (Sanofi-Aventis)
      in Type 1 Diabetes Mellitus Patients using the euglycemic clamp technique
    

Intervention name(s): RinGlar®; Lantus®
Intervention type(s): Drug; Drug
Intervention description(s): Single subcutaneous administration of RinGlar® in dose 0.6 Units/kg; Single subcutaneous administration of Lantus® in dose 0.6 Units/kg
Other intervention name(s): insulin glargine; insulin glargine
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Insulin Glargine
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: two-way crossover
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: Pharmacokinetics; Pharmacodynamics; Insulin glargine
A Study to Evaluate the Efficacy and Safety of Amlodipine Besylate and Candesartan Cilexetil in Essential Hypertension Patient Who Are Not Adequately Controlled With Amlodipine Besylate Monotherapy
Condition: Essential Hypertension
MeSH terms: Hypertension; Essential Hypertension
Study type: Interventional
Phase: Phase 3

Summary: 
      Compare the safety and efficacy of amlodipine besylate and candesartan cilexetil combination
      therapy on patients of essential hypertension who are not properly controlled by amlodipine
      besylate monotherapy.
    


Intervention name(s): Amlodipine 5mg; Amlodipine 5mg, Candesartan cilexetil 16mg; Amlodipine 10mg, Candesartan cilexetil 16mg
Intervention type(s): Drug; Drug; Drug
Intervention description(s): - Daily oral administration for 8 weeks; - Daily oral administration Amlodipine 5mg for 8 weeks; - After 8 weeks of administration, Amlodipine 10mg and Candesartan cilexetil 16mg once a day for 8 weeks
Other intervention name(s): Novarsc 5mg; Novarsc 5mg, Atacand 16mg; Novarsc 10mg, Atacand 16mg
Intervention MeSH terms: Amlodipine; Candesartan; Candesartan cilexetil
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Topical Bimatoprost Effect on Androgen Dependent Hair Follicles
Condition: Male Pattern Hair Loss; Androgenetic Alopecia
MeSH terms: Alopecia; Alopecia Areata
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine the effect of bimatoprost solution on scalp hair
      growth. Bimatoprost 0.03% ophthalmic solution is currently approved by the FDA for treatment
      of glaucoma (Lumigan™) and for thickening of thin eyelashes (Latisse™). Bimatoprost 0.03% is
      not approved for the treatment of scalp hair loss and its use in this study is considered
      investigational which means it is still being tested in research studies.

      Thirty-three subjects were consented and screened, 9 entered and 9 completed the study.
    


Intervention name(s): Bimatoprost; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Bimatoprost 0.03% ophthalmic solution as purchased from the manufacturer will be the active drug.
Intervention MeSH terms: Bimatoprost
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: male pattern hair loss; androgenetic alopecia; bimatoprost
Effects of DASH Diet on Corticosteroids Medication Use
Condition: Nutritional and Metabolic Disease
MeSH terms: Metabolic Diseases
Study type: Interventional
Phase: Phase 3

Summary: 
      To determine the effects of the Dietary Approaches to Stop Hypertension (DASH) diet on the
      metabolic side effects of corticosteroids medications use.
    

Detailed description: 
      Objective: To determine the effects of the Dietary Approaches to Stop Hypertension (DASH)
      diet on the metabolic side effects of corticosteroids medications use.

      Design: A randomized clinical trial was undertaken in 60 patients on corticosteroid therapy
      for 10 weeks. Patients were randomly assigned to a DASH or control diet. Fasting blood sample
      were measured to determine blood glucose and lipid profile. Blood pressure and anthropometric
      measurements were measured based on the standard guidelines.
    

Intervention name(s): nutrition intervention
Intervention type(s): Other
Intervention description(s): DASH diet control diet
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Tanezumab in Osteoarthritis Of The Hip
Condition: Arthritis; Osteoarthritis; Osteoarthritis, Hip
MeSH terms: Osteoarthritis; Osteoarthritis, Hip
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to test the efficacy and safety of 3 doses of tanezumab in
      osteoarthritis of the hip in patients
    


Intervention name(s): tanezumab; tanezumab; tanezumab; Placebo
Intervention type(s): Biological; Biological; Biological; Biological
Intervention description(s): Tanezumab 10 mg IV every 8 weeks; Tanezumab 5mg IV every 8 weeks; Tanezumab 2.5 mg IV every 8 weeks.; Placebo to match tanezumab IV every 8 weeks
Intervention MeSH terms: Tanezumab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: monoclonal antibody RN624 PF-04383119 nerve growth factor anti-nerve growth OA
Muscle Soreness and Stiffness in Patients With Chronic or Frequent Episodic Tension Type Headache.
Condition: Tension-type Headache
MeSH terms: Myalgia; Tension-Type Headache; Headache
Study type: Interventional

Summary: 
      The aim is to investigate muscle soreness and stiffness in patients with Chronic or Frequent
      Episodic Tension Type Headache before and after treatment with amitriptyline - and to compare
      the results with healthy individuals.
    

Detailed description: 
      The muscle stiffness is measured with ultrasonic shear wave elastography in m. masseter, m.
      sternocleidomastoid and m. Trapezius.

      The muscle soreness is measured by palpation of the muscles aided by a so called palpometer.
    

Intervention name(s): Amitriptyline
Intervention type(s): Drug
Intervention description(s): The investigator recruits patients who have already discussed and agreed to the amitriptyline treatment with their physician. The patients start the treatment after the investigator have measured them once.
Other intervention name(s): Saroten; Tricyclic antidepressants
Intervention MeSH terms: Amitriptyline; Antidepressive Agents; Antidepressive Agents, Tricyclic
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Perception of Facial Expressions Following Correction of Wrinkles and Folds
Condition: Wrinkles and Folds in Lower Face
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to evaluate the perception of facial expressions following
      correction of wrinkles and folds in the lower face using Emervel Classic Lidocaine and
      Emervel Deep Lidocaine.
    


Intervention name(s): Emervel Classic Lidocaine; Emervel Deep Lidocaine
Intervention type(s): Device; Device
Intervention description(s): Treatment of wrinkles and folds; Treatment of wrinkles and folds
Intervention MeSH terms: Lidocaine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment