bioihbjkbjnl/mcl2 huggingface dataset:
Multicenter Study to Evaluate the Clinical and Cost Effectiveness of a Youth Culturally Adapted Therapy (YCMAP)
Condition: Self Harm
MeSH terms: Self-Injurious Behavior
Study type: Interventional

Summary: 
      To evaluate the clinical and cost-effectiveness of a youth culturally adapted manual assisted
      therapy (YCMAP) in Pakistani Adolescents with a history of self-harm
    

Detailed description: 
      Globally suicide is the second leading cause of death in young people 15-29 years of age. A
      recent review indicated that the reported suicide rates in South Asia are high compared to
      the global average. These figures are likely to be an under estimate since suicide data from
      many Low and Middle Income Countries (LMICs) is lacking. There is little official data on
      suicide from Pakistan, where suicide and self-harm remains as criminal act and socially,
      religiously condemned. However, there is accumulating evidence that both self-harm and
      suicide rates have been increasing in Pakistan.

      This is the first RCT of a psychological intervention for self-harm in children and young
      people in Pakistan. It follows from the work of "Multicentre RCT to evaluate the clinical and
      cost effectiveness of culturally adapted manual assisted psychological intervention"(CMAP)
      trial currently taking place in adults who have self-harmed in Pakistan, by evaluating
      whether a similar intervention, adapted for children and adolescents, could be clinically and
      cost effective.
    

Intervention name(s): Youth Culturally Adapted Manual Assisted Psychological Therapy (Y-CMAP)
Intervention type(s): Behavioral
Intervention description(s): Y-CMAP is a manual assisted brief psychological intervention based on the principles of Cognitive Behaviour Therapy (CBT), including 8-10 sessions delivered over three months.
This intervention includes evaluation of the self-harm attempt, psycho education, crisis skills, problem solving and simple cognitive techniques to manage emotions, negative thinking,relapse prevention strategies and training on anger management and assertiveness.
Other intervention name(s): Psychosocial Intervention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: Self-harm, adolescents, adaptation, problem solving, LMICs
Investigation of the Effects of Balance Training on Balance and Functional Status Patients With Total Hip Arthroplasty
Condition: Arthroplasty Complications; Physical Disability; Osteoarthritis, Hip
MeSH terms: Osteoarthritis; Osteoarthritis, Hip
Study type: Interventional

Summary: 
      The purpose of this study is to investigate the effects of balance training in patients with
      THA until 26 weeks postoperatively. Thirty-two patients with hip osteoarthritis who were
      candidates for THA were recruited to the study. Sixteen patients with THA completed the study
      protocol and the patients were randomized into 2 groups: conventional rehabilitation (CR,
      n=8) or conventional rehabilitation plus balance training (CR + BT, n=8) groups. The patients
      were evaluated by hand-held dynamometer, single leg stance test (SLST), Tetrax balance
      system, Harris hip score, lower extremity function scale, 5 times sit-to-stand test and 50
      foot timed walk test preoperatively and in the 8th, 14th and 26th weeks postoperatively.
    


Intervention name(s): Exercise training
Intervention type(s): Other
Other intervention name(s): conventional rehabilitation; conventional rehabilitation and balance training
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: osteoarthritis; hip; total hip arthroplasty; balance training; function; assessment
Effectiveness of a Paleolithic Based Diet Compared to MyPlate Guidelines, With and Without Exercise, in Women.
Condition: Healthy
Study type: Interventional

Summary: 
      The purpose of this study is to determine the effectiveness of recommending either a
      Paleolithic based diet or the United States Department of Agriculture MyPlate guidelines with
      or without exercise on physical conditioning, hormones related to energy metabolism, body
      composition, resting energy expenditure, blood biomarkers, and urine in young, adult females.
    


Intervention name(s): MyPlate; MyPlate + Exercise; Paleolithic; Paleolithic + Exercise
Intervention type(s): Behavioral; Behavioral; Behavioral; Behavioral
Intervention description(s): To consume a weight maintenance diet based on the United States Department of Agriculture MyPlate nutrition recommendations for eight weeks.; To consume a weight maintenance diet based on the United States Department of Agriculture MyPlate nutrition recommendations and aerobic and resistance training four days per week for eight weeks.; To consume a weight maintenance diet based on alternative (Paleolithic based) nutrition recommendations for eight weeks.; To consume a weight maintenance diet based on alternative (Paleolithic based) nutrition recommendations and aerobic and resistance training four days per week for eight weeks.
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: None (Open Label)
Exploring Muscle Breakdown During Exercise Recovery
Condition: Muscle Damage; Healthy
Study type: Interventional

Summary: 
      This study will allow researchers to explore how muscle responds to heavy exercise. The
      researchers will characterise rates of muscle protein breakdown and synthesis 24hours after
      heavy exercise with a post exercise protein polyphenol or placebo supplementation. This will
      inform strategies to help people recover from heavy exercise.
    

Detailed description: 
      It is well known that resistance exercise increases rates of muscle protein synthesis and
      breakdown, with the rise in synthesis greater in magnitude and duration. The time course of
      rates of muscle protein synthesis increase dramatically 24-72h following eccentric exercise,
      even in a non-exercised control leg. This data is consistent with a much larger increase in
      muscle protein breakdown than previously thought. However, the response of muscle protein
      breakdown following damaging eccentric exercise, and its relationship with muscle protein
      synthesis, has not yet been elucidated. Moreover, it is unclear whether a protein and
      polyphenol nutritional intervention influence rates of muscle protein breakdown to accelerate
      recovery. This study will allow researchers to test the hypothesis that eccentric exercise
      increases rates of muscle protein breakdown independently of muscle contraction per se. If
      this hypothesis is supported, it will highlight that recovery strategies from muscle damage
      should also target supporting muscle protein breakdown.
    

Intervention name(s): Recover Vegan Protein Supplement; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Post exercise protein supplement (26g pea protein); Post exercise placebo supplement (32g maltodextrin)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Other
Keywords: Skeletal muscle; Postabsorptive; Muscle protein breakdown; Muscle protein synthesis
Bioavailability Study of Desloratadine 5 mg Tablet of Dr. Reddy's Under Fed Conditions
Condition: Fed
MeSH terms: Malnutrition
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to compare the rate and extent of absorption of Dr. Reddy's
      Desloratadine 5 mg tablet to that of Clarinex® 5 mg tablet in healthy subjects under fed
      conditions.
    

Detailed description: 
      A Randomized, Single-Dose, Two-Way Crossover Relative Bioavailability Study of Desloratadine
      5 mg Tablet in fed Normal,Healthy subjects.
    

Intervention name(s): Desloratadine
Intervention type(s): Drug
Intervention description(s): Desloratadine Tablets, 5 mg
Other intervention name(s): Clarinex® 5 mg
Intervention MeSH terms: Desloratadine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Effects of Two Packing Type in Maxillofacial Surgery
Condition: Sore Throat; Nausea and Vomiting, Postoperative
MeSH terms: Pharyngitis; Nausea; Vomiting; Postoperative Nausea and Vomiting
Study type: Interventional
Phase: Phase 4

Summary: 
      Operations of oral maxillofacial surgery cause the blood escape into stomach and trachea.
      Therefore, throat packing is applied. Endotracheal tube cuff is not protective from
      aspiration. While packing is preventing blood leakage, it may cause postoperative pain due to
      the pressure. Packing placed between oropharynx and hypopharynx before surgery to prevent
      leakage to stomach and trachea. The aim of this study is to compare the efficacy of two
      packing types in throat pain.
    


Intervention name(s): chlorhexidine gluconate %0,12 benzydamine hydrochloride %0,15; %0.9 NaCl Solution
Intervention type(s): Drug; Other
Intervention description(s): chlorhexidine gluconate + benzydamine hydrochloride oral rinse; isotonic sodium chloride
Intervention MeSH terms: Chlorhexidine; Chlorhexidine gluconate; Benzydamine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Prevention
An Open Label Study to Determine the Safety and Efficacy of Recombinant Human Coagulation Factor VIII-Fc Fusion Protein for Injection in Adolescent and Adult Patients With Hemophilia A.
Condition: Hemophilia A
MeSH terms: Hemophilia A
Study type: Interventional
Phase: Phase 3

Summary: 
      The primary objectives of the study are to evaluate the efficacy of Recombinant Human
      Coagulation Factor VIII-Fc Fusion Protein for Injection (FRSW107) in the Prevention and
      Treatment of Bleeding in patients with hemophilia A.

      The secondary objectives are to evaluate the efficacy and safety of Recombinant Human
      Coagulation Factor VIII-Fc Fusion Protein for Injection (FRSW107) in the prevention and
      treatment of bleeding episodes, to investigate the quality of life in patients who used the
      FRSW107.
    


Intervention name(s): Recombinant Human Coagulation Factor VIII-Fc Fusion Protein for Injection; Recombinant Human Coagulation Factor VIII-Fc Fusion Protein for Injection
Intervention type(s): Drug; Drug
Intervention description(s): Participants received on-demand treatment, doses range from 30 IU/kg to 50 IU/kg, or doses divided on the discretion of the Investigator.; Participants received prophylaxis treatment at 50 IU/kg every three days.
Intervention MeSH terms: Factor VIII; Immunoglobulin Fc Fragments
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Hemophilia A; Efficacy and Safety; Factor VIII-Fc Fusion Protein; Adolescent and Adult Patients; Phase III; Pharmacokinetics
The Impact of Generic Labels on Compliance
Condition: Generic Label; Brand-name Label
Study type: Interventional

Summary: 
      Although generic drugs are pharmacologically equivalent to their brand-name counterparts,
      prejudices against the former remain strong among patients and doctors. In a randomized
      controlled field experiment, this research assesses the extent to which generic (versus
      brand-name) labels affect patients' consumption dosage, medication compliance and reported
      pain.
    

Detailed description: 
      One hundred one patients scheduled to undergo invasive dental surgeries (i.e., dental
      implants) participated in the experiment. After dental surgery, patients were prescribed a
      once-daily analgesic regimen for up to 7 days. The intervention consisted of label
      manipulation. Patients were randomly assigned to either the brand-name analgesic or to its
      (purportedly) cheaper generic version. In reality, all participants obtained the same
      brand-name medication. The medication was provided at no cost, and patients were instructed
      to take the first pill while at the clinic. They were informed that they could (a) increase
      the dosage of the prescribed analgesic to twice daily if necessary and (b) stop taking the
      medication when no longer needed. Any other changes to the regimen were discouraged, and
      patients were instructed to consult with the dentist before any such changes. Telephone
      follow-ups were conducted at 24 hours, 4 days, and 7 days after surgery. Two main dependent
      variables were obtained: the number of prescribed analgesics consumed and the number of
      non-prescribed analgesics consumed. The patients also reported the pain felt during the
      period.
    

Intervention name(s): Label
Intervention type(s): Other
Intervention description(s): Participants were presented with either a generic label or a brand-name label
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Post-Marketing Surveillance (PMS) Protocol of REKOVELLE Pre-Filled Pen (Follitropin Delta)
Condition: Infertility, Female
MeSH terms: Infertility; Infertility, Female
Study type: Observational

Summary: 
      This post-marketing surveillance study is conducted in accordance with the regulations for
      re-examination of domestic new drugs (Standard for Re-Examination of New Drugs: Ministry of
      Food and Drug Safety [MFDS]: Notification No. 2017-95, 21 Nov, 2017).

      It is important to monitor the pattern of drug use in general practice for a long term after
      marketing authorization, and to investigate and identify potential new adverse events (AEs)
      and their onset status that were not observed during the drug development phases and any
      potential factors that affect safety and effectiveness of the new drug.
    


Intervention name(s): Other: Non intervention
Intervention type(s): Other
Intervention description(s): Non intervention
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Women receiving REKOVELLE pre-filled pen (follitropin delta) within the range of the
        approved product labeling in Korea. Patients will be enrolled only after the treatment
        decision has been made and no aspect of this study will interfere with or influence the
        routine medical procedures and/or medications received.
      
Keywords: Follitropin Delta; REKOVELLE
SA4503 8-Week Study in Major Depressive Disorder (MDD)
Condition: Depressive Disorder, Major
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine the efficacy of SA4503 compared to placebo in the
      treatment of subjects with major depressive disorder (MDD). Secondary, to evaluate the safety
      of SA4503 compared to placebo in subjects with MDD.
    

Detailed description: 
      Further study details as provided by M's Science Corporation:
    

Intervention name(s): placebo; SA4503 Low; SA4503 High
Intervention type(s): Drug; Drug; Drug
Intervention description(s): placebo, oral administration, once daily for 8 weeks; Low dose, oral administration, once daily for 8 weeks; High dose, oral administration, once daily for 8 weeks
Intervention MeSH terms: SA 4503
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Randomized Evaluation of Atrial Fibrillation Treatment With Focal Impulse and Rotor Modulation Guided Procedures
Condition: Persistent Atrial Fibrillation
MeSH terms: Atrial Fibrillation
Study type: Interventional

Summary: 
      The study is a prospective, multicenter, randomized study to assess the safety and
      effectiveness of FIRM procedures followed by conventional ablation including PVI versus a
      standard PVI procedure for the treatment of persistent atrial fibrillation (AF).
    


Intervention name(s): Standard PVI Ablation; FIRM-Guided Procedure and PVI
Intervention type(s): Procedure; Procedure
Intervention description(s): Standard PVI procedure without FIRMap.; FIRM-guided procedure followed by conventional ablation including PVI.
Other intervention name(s): Pulmonary vein isolation; Ablation; Arrhythmia; Persistent atrial fibrillation; Mapping; Pulmonary vein isolation; Ablation; Arrhythmia; Persistent atrial fibrillation; Mapping; FIRMap
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Focal Impulse and Rotor Modulation Mapping Catheter (FIRMap); Rotor; FIRM-guided procedure; REAFFIRM
Assessing the Feasibility of a Novel Non-Invasive Sensor for Guiding Wounded Warrior Rehabilitation
Condition: Rehabilitation Post-amputation
Study type: Interventional

Summary: 
      The purpose of this study is to test a low cost, non-invasive, wearable near-infrared
      spectroscopy (NIRS) sensor, previously validated for able-bodied athletes as a rehabilitation
      aid for war-fighters with lower extremity limb loss. This sensor can record real-time
      physiologic data that relates to total fitness capacity and exertion levels and may help
      develop individualized programs on a per-patient basis. The uniqueness of this NIRS
      measurement system is that it provides real-time muscular oxygenation, dehydration, and iron
      status during whole-body exercise, as well as training-induced adaptations. Currently, no
      technology like this has been tested in an amputee population. Successfully validating this
      technology in a wounded warrior population would provide vital information regarding tissue
      perfusion after injury and new opportunities for improving rehabilitation outcomes.
    


Intervention name(s): Near-Infrared Spectroscopy (NIRS) Sensor
Intervention type(s): Device
Intervention description(s): These sensors utilize NIRS to evaluate oxygenated and deoxygenated hemoglobin, total oxygenation index and total blood flow. This is done by bouncing infrared light off of chromatophores (located within red blood cells), which is then refracted off of the cells in the capillary beds to the topical sensor.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Alendronate Prevents Microarchitectural Deterioration of Trabecular Bone in Early Postmenopausal Women
Condition: Osteopenia; Osteoporosis
MeSH terms: Osteoporosis; Bone Diseases, Metabolic
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to evaluate the changes in bone structure as determined by
      magnetic resonance imaging measurements among early postmenopausal women after 24 months of
      treatment with alendronate, 70 mg once a week as compared to placebo
    

Detailed description: 
      This is a randomized, double-blind, 24-month study. Fifty-five postmenopausal women, age
      range of 45-65 years, with low bone density will be recruited, with half of the subjects
      receiving alendronate + 2800 IU of vitamin D once weekly, the other half receiving placebo +
      2800 IU of vitamin D once weekly. All study subjects will receive supplemental calcium 1000
      mg/day + Vitamin D 400 IU/day. Measurements of microarchitecture will be made in the wrist,
      ankle, and hip, and the changes in trabecular bone will be assessed at 0, 12 and 24 months.
      Markers of bone turnover and bone mineral density (BMD) will be used to characterize the
      cohort and postmenopausal changes in bone turnover and density.
    

Intervention name(s): alendronate sodium; placebo comparator
Intervention type(s): Drug; Other
Intervention description(s): alendronate sodium 70 mg tablet once week for 24 months; placebo to match alendronate sodium one tablet once a week for 24 months
Other intervention name(s): fosamax; sugar pill
Intervention MeSH terms: Alendronate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
A Study to Learn How Much Rosuvastatin Gets Into the Blood When Taken With or Without Elinzanetant and to Learn About the Safety of Elinzanetant in Healthy Participants
Condition: Vasomotor Symptoms as a Sex Hormone-dependent Disorder in Women and Men
Study type: Interventional
Phase: Phase 1

Summary: 
      Researchers are looking for a better way to treat people who have symptoms caused by hormonal
      changes, like those that happen in women during menopause. These symptoms can include
      vasomotor symptoms. Before a treatment can be approved for patients to take, researchers do
      clinical studies to better understand its safety and what happens to the treatment in the
      body.

      The study drug, elinzanetant, was designed to treat vasomotor symptoms. Rosuvastatin is
      already approved for doctors to prescribe and is used to treat high cholesterol levels and
      prevent heart problems. It is important for researchers to know if taking elinzanetant will
      affect how other drugs work in the body. Researchers regularly use rosuvastatin in studies to
      learn how it affects drugs like elinzanetant.In this study, the researchers will study how
      much elinzanetant gets into the participants' blood when taken with or without rosuvastatin.
      The study will include about 16 male participants who are between 18 and 65 years old. The
      participants will all take 5 milligrams (mg) of rosuvastatin and 120 mg of elinzanetant as
      capsules by mouth. On some days, they will take only rosuvastatin or only elinzanetant. On
      other days, they will take both study treatments. Each participant will be in the study for
      up to 6 weeks. But, the entire study will last about 2.5 months.

      During the study, all of the participants will stay at the study site for 17 days. Blood and
      urine samples will be collected. The physician will also check the participants' heart health
      using an electrocardiogram (ECG). The participants will answer questions about how their well
      being and taken medications.
    


Intervention name(s): Elinzanetant (BAY3427080); Rosuvastatin
Intervention type(s): Drug; Drug
Intervention description(s): Once daily over 12 days; Single doses on Day 1, Day 8, and Day 13
Intervention MeSH terms: Rosuvastatin Calcium
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Vasomotor symptoms
A Phase III Trial Assessing the Pharmacodynamic Effect and the Tolerability of Grazax Treatment
Condition: Grass Pollen Allergy
MeSH terms: Rhinitis, Allergic, Seasonal
Study type: Interventional
Phase: Phase 3

Summary: 
      The study assess the pharmacodynamic effect and the tolerability of Grazax treatment
      initiated in the grass pollen season in subjects with seasonal grass pollen induced
      rhinoconjunctivitis
    


Intervention name(s): Grazax; placebo
Intervention type(s): Drug; Drug
Intervention description(s): 1 tablet, 75,000 SQ-T, daily during the trial period; 1 placebo tablet, matching the active treatment, daily during the trial period
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment