bioihbjkbjnl/mcl2 huggingface dataset:
Effect of Angeliq on Blood Pressure (BP) in Postmenopausal Hypertensive Women
Condition: Hypertension; Postmenopause
MeSH terms: Hypertension; Essential Hypertension
Study type: Interventional
Phase: Phase 3

Summary: 
      The objective of the study is to evaluate the effects of Angeliq on BP over a period of 8
      weeks in postmenopausal women who may benefit from hormone replacement therapy (HRT) for the
      relief of vasomotor symptoms and who have hypertension.
    

Detailed description: 
      This study has previously been posted by Berlex, Inc. Berlex, Inc. has been renamed to Bayer
      HealthCare Pharmaceuticals, Inc.Bayer HealthCare Pharmaceuticals, Inc.is the sponsor of the
      trial.
    

Intervention name(s): Angeliq (Drospirenone/17ß-estradiol, BAY86-4891); Angeliq (Drospirenone/17ß-estradiol, BAY86-4891); Angeliq (Drospirenone/17ß-estradiol, BAY86-4891); Angeliq (Drospirenone/17ß-estradiol, BAY86-4891); Placebo
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): Drospirenone 3 mg + 1mg 17ß-estradiol, given as tablets orally once daily in the morning for 8 weeks; Drospirenone 2 mg + 1mg 17ß-estradiol, given as tablets orally once daily in the morning for 8 weeks; Drospirenone 1 mg + 1mg 17ß-estradiol, given as tablets orally once daily in the morning for 8 weeks; 1mg 17ß-estradiol, given as tablets orally once daily in the morning for 8 weeks; Placebo, given as tablets orally once daily in the morning for 8 weeks
Intervention MeSH terms: Drospirenone; Estradiol 17 beta-cypionate; Estradiol 3-benzoate; Ethinyl Estradiol; Drospirenone and ethinyl estradiol combination; Estradiol; Polyestradiol phosphate
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Postmenopausal; vasomotor symptoms; essential hypertension
Effect of Activated Charcoal on Rivaroxaban Pharmacokinetics in Healthy Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      Rivaroxaban is a direct oral anticoagulant that target specifically activated factor X.
      Bleeding events related to rivaroxaban are the consequence of physiopathologic,
      pharmacokinetic issues or poisoning. Few results are available on the use of activated
      charcoal in rivaroxaban poisoning. Moreover, a recent study, in healthy subjects, shows that
      activated charcoal can reduce significantly exposition to apixaban (a direct oral
      anticoagulant of the same class). The objective of this study is to evaluate the effect of
      activated charcoal on rivaroxaban pharmacokinetics. It corresponds to a randomised open trial
      with an incomplete cross over design (3 occasions). It will enrol 12 healthy subjects. Four
      treatments modalities will be studied: rivaroxaban alone and rivaroxaban with activated
      charcoal administrated 2, 4 or 8 hours after rivaroxaban administration.
    


Intervention name(s): rivaroxaban; rivaroxaban and activated charcoal
Intervention type(s): Drug; Drug
Intervention description(s): rivaroxaban 40 mg/day (1 day); rivaroxaban 40 mg/day (1 day) and 50 g of activated charcoal 2 or 5 or 8 hours after rivaroxaban administration (1 day)
Intervention MeSH terms: Rivaroxaban; Charcoal
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Single (Outcomes Assessor)
Keywords: Rivaroxaban, pharmacokinetics, activated charcoal, poisoning
Post Mastectomy Shoulder Problems and Kinesio Taping
Condition: Post Mastectomy Complications
Study type: Interventional

Summary: 
      Applications of new treatment modality which is Kinesio tape in post mastectomy shoulder
      problems.
    

Detailed description: 
      Post-mastectomy complications are often noted and complaints by breast cancer survivors. It
      often involves the development of chronic arm pain with accompanying limitation of shoulder
      motion. Aim of the study was to investigate the effect of the kinesio tape (KT) on the
      shoulder pain and range of motion (ROM).

      Method: 74 female patients underwent modified radical mastectomy were involved in this study.
      They were randomly divided into two groups, experimental who received KT for shoulder joint
      in addition to conventional physiotherapy program while, the control group received the
      physiotherapy program only. Outcome measures were visual analogues scale, shoulder ROM and
      shoulder Pain and Disability Index.
    

Intervention name(s): Kinesio tape; physiotherapy program
Intervention type(s): Device; Procedure
Intervention description(s): Standard 2 -inches ( 5-m) Kinesio TexR tape was used for application in the experimental group; active-assistive range of motion exercises (AAROME), active stretching exercises and strengthening exercises for the shoulder joint. Likewise, patients also received postural correction exercises
Other intervention name(s): Kinesio TexR tape; exercises
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Mastectomy; Shoulder Pain; ROM; Kinesio Tape
An Investigational Drug Study in Patients With Type 2 Diabetes Mellitus (MK0431-023)
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to determine the safety and effectiveness of an investigational
      drug in patients with Type 2 Diabetes Mellitus.
    


Intervention name(s): Comparator: sitagliptin 100 mg; Comparator: sitagliptin 200 mg; Comparator: placebo; Comparator: pioglitazone
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): sitagliptin 100 mg oral tablet once daily for 54 weeks; sitagliptin 200 mg (2- 100 mg oral tablets) once daily for 54 weeks; placebo oral tablet once daily during Phase A (Weeks 0-18); pioglitazone 30 mg oral tablet once daily during Phase B (Weeks 18-54)
Intervention MeSH terms: Pioglitazone; Sitagliptin Phosphate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Immediate Effects Cervicothoracic Manipulation Versus Passive Upper Trapezius Stretch
Condition: Neck Pain
MeSH terms: Neck Pain
Study type: Interventional

Summary: 
      The proposed project seeks to evaluate the influence of cervicothoracic (CT) manipulation and
      passive stretching to the upper trapezius on pressure pain thresholds and range of motion
      (ROM) in individuals without recent complain of neck pain.
    

Detailed description: 
      Not needed
    

Intervention name(s): Upper Trapezius Stretch; Cervicothoracic manipulation; No intervention
Intervention type(s): Other; Other; Other
Intervention description(s): Sustained stretch of upper trapezius muscle; Manipulation to the cervicothoracic spine; Wait
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Central Neuromodulation of Pain Through Music in Healthy Subjects
Condition: Pain
Study type: Interventional

Summary: 
      The present research aims to study the neuromodulatory effect of music on the sensory
      component of pain. The activation of pain control systems, through music, would pave the way
      for rehabilitation prospects for patients with a deficit of these controls.
    

Detailed description: 
      Pain is a multidimensional, complex and universal phenomenon that would be faced by almost
      one in two European adults. To meet the needs in terms of public health, contemporary
      medicine is gradually reintegrating the use of complementary therapeutic methods. Music
      therapy is a non-medical intervention that is particularly suited to pain problems. The
      therapeutic use of music is an economical, practical and safe method. Many clinical studies
      show that this activity promotes a significant decrease in pain. The ability of passive
      listening to music to reduce the perception of pain has been called "music-induced
      analgesia". The neuro-psycho-physiological mechanisms that underlie this phenomenon remain
      poorly understood. One hypothesis, still discussed, proposes that listening to music would
      stimulate, directly or indirectly, endogenous mechanisms of modulation of pain, stemming from
      the brainstem. In individuals undergoing nociceptive tonic stimulation, the specific neuronal
      activation induced by listening to music demonstrates the involvement of inhibitory
      descending pathways. A measurement of pain control mechanisms would account for the impact of
      music on central awareness.

      The purpose of this research is therefore to study the neuromodulatory effect of music on the
      sensory component of pain. The activation of pain control systems, through music, would pave
      the way for rehabilitation prospects for patients with a deficit of these controls.
    

Intervention name(s): Without music; With music
Intervention type(s): Procedure; Procedure
Intervention description(s): The starting condition will be "without music": the subjects, after a rest period of 10 minutes, will perform a test of induced pain for 6 minutes. There will be no music for the duration.; The starting condition will be "with music": the subjects, after a rest period of 10 minutes, will perform a test of induced pain for 6 minutes. There will be music for the duration.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Multiple Ascending Dose Study in Healthy Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will assess in healthy male and female subjects the safety, tolerability and
      pharmacokinetics (PK) profiles of Immediate Release CTP-730 at steady state following 7 days
      of dosing. Three doses of Immediate Release (IR) CTP-730 capsules will be studied.
    


Intervention name(s): CTP-730; Placebo for CTP-730
Intervention type(s): Drug; Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Basic Science
Keywords: Safety/Efficacy Study; Randomized; Double Blind
A Study to Investigate How Safe and Effective Solifenacin Solution is in Treating Children/Adolescents With Symptoms of Overactive Bladder (OAB) Who Completed Study 905-CL-076
Condition: Urinary Bladder, Overactive
MeSH terms: Urinary Bladder, Overactive
Study type: Interventional
Phase: Phase 3

Summary: 
      This was a 40-week study to investigate how safe and effective solifenacin solution was in
      treating children or adolescents with symptoms of overactive bladder (OAB), who completed
      study 905-CL-076 (NCT01565707).
    

Detailed description: 
      There was a titration period of up to 12 weeks during which the participants would be up or
      down-titrated based on a combination of efficacy and safety parameters followed by a fixed
      dose period during which no dose adjustments were allowed. Participants completed a 7-day
      patient diary prior to every visit (start of 905-CL-076 to end of 905-CL-077, 14 visits). The
      first visit of this study (905-CL-077) was combined with the last visit of the 4-month study
      905-CL-076. At each visit, the participant was required to undertake a number of assessments
      or examinations to determine whether it is safe for him/her to take part or to continue to
      take part in the study.
    

Intervention name(s): Solifenacin succinate suspension
Intervention type(s): Drug
Intervention description(s): Oral suspension
Other intervention name(s): YM905; solifenacin succinate
Intervention MeSH terms: Solifenacin Succinate
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Overactive bladder (OAB); Solifenacin succinate suspension; Phase 3; Pediatric
Effect of Gemigliptin on Metabolic Endotoxemia and Lipemia
Condition: Type 2 Diabetes Mellitus
MeSH terms: Endotoxemia; Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      This is an exploratory study on the metabolic endotoxemia associated with type 2 diabetes.
      The investigators will measure systemic endotoxin level and lipid level after ingestion of
      high fat diet to evaluate the effect of gemigliptin, a DPP-4 inhibitor, on metabolic
      endotoxemia and lipemia induced by high fat diet.
    

Detailed description: 
      Study subjects will be allocated to either gemigliptin or placebo. After 4 weeks of treatment
      and 2 weeks of wash out period, all subjects will be switched to the opposite arm.

      The subjects will be tested oral fat tolerance test and adipose tissue needle biopsy(only for
      the subjects who agreed to participate donate adipose tissue) at 3 time points: the start of
      1st treatment, end of 1st treatment and end of 2nd treatment.
    

Intervention name(s): Gemigliptin; Placebo
Intervention type(s): Drug; Drug
Other intervention name(s): Zemiglo
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: diabetes mellitus; metabolic endotoxemia; gemigliptin; DPP-4 inhibitor
A Trial of Aprepitant For Prevention of Post-Endoscopic Retrograde Cholangiopancreatography (ERCP) Pancreatitis
Condition: Pancreatitis
MeSH terms: Pancreatitis
Study type: Interventional

Summary: 
      The purpose of this study is to determine if giving Aprepitant 4 hours before and for two
      days after ERCP decreases the risk of developing pancreatitis after ERCP.
    

Detailed description: 
      This study involves taking a drug Aprepitant by mouth 4 hours before the ERCP and once a day
      for two days after the ERCP, in an attempt to reduce the risk of pancreatitis caused by ERCP.
      Pancreatitis, or injury and inflammation of the pancreas, is the most common complication of
      ERCP and occurs in approximately 6 out of every 100 patients undergoing ERCP. It may result
      in pain and lead to hospitalization and, in some cases, a need for further procedures such as
      surgery.

      Aprepitant is a medication that is currently used to prevent nausea and vomiting in some
      patients caused by chemotherapy for the treatment of cancer. It is also approved for the
      prevention of post-operative nausea and vomiting. There is theoretical evidence from animal
      studies that the way in which Aprepitant works in the body may prevent pancreatitis.
    

Intervention name(s): aprepitant; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): one dose of aprepitant (125 mg PO 4 hours) prior to their ERCP and one dose (80 mg PO) 18 hours after the first dose; one dose of placebo (125 mg PO 4 hours) prior to their ERCP and one dose (80 mg PO) 18 hours after the first dose
Intervention MeSH terms: Aprepitant
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: pancreatitis
Locally Injected Vit D as a Non-surgical Modality for Periodontal Regeneration of Infrabony Defects
Condition: Periodontal Bone Loss; Periodontal Pocket
MeSH terms: Alveolar Bone Loss; Periodontal Pocket
Study type: Interventional

Summary: 
      vitamin D has great role in bone regenration and soft tissue health. in the past periodontal
      regeneration was performed using bone graft and barrier membrane
    

Detailed description: 
      there was no previous studies used the locally injected vitamin d in periodontal
      regeneration. therefore, we intended to study the effect of locally injected vitamin D in
      peridoontal regerneration in comparison with the conventional surgical technique
    

Intervention name(s): locally injected vitamin D
Intervention type(s): Dietary Supplement
Intervention description(s): locally injected vitamin d as non surgical method for periodontal regeneration of vertical bony defects
Other intervention name(s): non-surgical periodontal rgeneration
Intervention MeSH terms: Vitamin D
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Care Provider, Investigator)
Primary purpose: Treatment
Efficacy of Two Yogurt Formulations in Healthy Humans
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is to evaluate the safety and efficacy of consumption of: L.Ruteri containing
      yogurt, L.Fermentum containing yogurt VERSUS placebo on plasma lipids, as well as
      gastrointestinal microflora distribution in hyperlipidemic individuals.
    


Intervention name(s): L. Amylovorus; L. Fermentum
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): L. Amylovorus; L. Fermentum
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Evaluation of Early Bactericidal Activity in Pulmonary Tuberculosis (TMC207-CL001)
Condition: Pulmonary Tuberculosis
MeSH terms: Tuberculosis; Tuberculosis, Pulmonary
Study type: Interventional
Phase: Phase 2

Summary: 
      The trial will evaluate the extended bactericidal activity of 14 consecutive days of oral
      administration of TMC207 at multiple doses as determined by the rate of change of log10
      colony forming units (CFU) per ml sputum over the time period Day 7-14 in participants with
      smear positive pulmonary tuberculosis (TB). A control group will receive standard treatment.
    


Intervention name(s): TMC207; Rifafour e-275 mg
Intervention type(s): Drug; Drug
Intervention MeSH terms: Bedaquiline
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Bedaquiline; Sirturo; Early Bactericidal Activity; EBA; Pulmonary Tuberculosis; TMC207
Health-related Quality of Life and Late Effects Among SURVivors of Cancer in Adolescence and Young Adulthood: The SURVAYA Study
Condition: Quality of Life; Late Effect; Survivorship; Lifestyle; Cancer
Study type: Observational

Summary: 
      Rationale: Adolescent and young adult (AYA) cancer survivors, diagnosed between 18-39 years,
      much more than children, suffer from delay in diagnosis, lack of centralization of care,
      age-adjusted expertise and follow-up care. The distribution of tumor types, biology, risk
      factors, developmental challenges and treatment regimens are different in AYAs compared to
      children. Therefore findings derived from childhood cancer survivors cannot be extrapolated
      to AYAs. Likewise, several large tumor-specific cohort studies exist that do not specifically
      address unique AYA age-specific issues. Globally, so far, the identification of AYA patient
      subgroups that might be more susceptible to poor health outcomes has not been systematically
      addressed. The role of sociodemographic and treatment-associated risks, external exposures
      (e.g. lifestyle) and host factors (e.g. genetic); or combinations of influences for impaired
      (age-specific) health outcomes, remains largely unknown. Understanding who is at risk and
      why, will support the development of evidence-based AYA prevention, treatment and supportive
      care programs and guidelines.

      Objective: To examine the prevalence, risk factors and mechanisms of impaired health outcomes
      (health-related quality of life and late effects) among a population-based sample of AYA
      cancer survivors. Study design: Retrospective, population-based, observational cohort study.

      Study population: AYA cancer survivors, diagnosed at age 18-39 years between 1999-2015,
      identified from the Netherlands Cancer Registry (NCR), and alive 5-20 year after diagnosis
      Main study parameters/endpoints: Health-related quality of life; late effects
    


Observational model: Cohort
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        All AYA cancer patients, diagnosed at age 18-39 years and treated in one of the
        participating hospitals
Osteopathy and Children With Congenital Heart Disease Surgery
Condition: Congenital Heart Disease
MeSH terms: Heart Diseases; Heart Defects, Congenital
Study type: Interventional

Summary: 
      Osteopathic care impact on postoperative pain assessed by osteopathic session, evaluated by
      EVENDOL scale surgery on children with congenital heart disease
    

Detailed description: 
      The management of pain in children after cardiac surgery is the key to ensure a better
      comfort and fast home return.

      Aside drugs and psychology or physical therapy, no other alternative is proposed in the
      medico-surgical unit of pediatric cardiology at the Necker hospital.

      Following a feasibility study within the department, osteopathic care showed significant pain
      reduction in postoperative surgery assessed through the EVENDOL scale.

      The goal was mainly to improve mobility restricted areas due to the operation, and so help to
      reduce post-operative pain.

      Investigators propose to continue the assessment of the overall osteopathic taking care of
      the child after heart surgery while retaining EVENDOL scale as primary endpoint. Population
      will include children from the age of 5 days to less than 7 years old.
    

Intervention name(s): Osteopathy; superficial palpatory agreement
Intervention type(s): Other; Other
Intervention description(s): The treatment begins, if possible, on the body part of the child whose osteopathic score is the highest , with the least elasticity and mobility. Then the other restricted joints will be treated. The set of techniques will be carried out after palpation and appropriate tensioning. The various actions will be carried out on the tissues and joints who have been particularly affected by the operation.
When a joint or tissue has a restricted mobility in a direction or a specific movement, it will require appropriate and gently manual correction, in order to reduce and improve its functionality.; The simulated treatment also begins with the body part of the child whose osteopathic score is the highest. Then the other restricted joints will be treated. The set of techniques will be carried out with the same investments as the tests , with a superficial palpatory agreement and without tensioning so that the restricted articulation or tissue will not be corrected
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment