bioihbjkbjnl/mcl2 huggingface dataset:
Dosage Form Proportionality of Opicapone To-Be-Marketed Formulation
Condition: Epilepsy
MeSH terms: Epilepsy
Study type: Interventional
Phase: Phase 1

Summary: 
      Single-centre, open-label, randomized, two-sequence, two-way crossover study. The study
      consisted of two consecutive single-dose treatment periods separated by a washout period of
      10 to 14 days or more.
    

Detailed description: 
      Single-centre, open-label, randomized, two-sequence, two-way crossover study. The study
      consisted of two consecutive single-dose treatment periods separated by a washout period of
      10 to 14 days or more. In Group 1 the volunteers received a single oral dose of 25 mg OPC. In
      Group 2 the volunteers received a single oral dose of 50 mg OPC
    

Intervention name(s): BIA 9-1067
Intervention type(s): Drug
Other intervention name(s): OPC, Opicapone
Intervention MeSH terms: Opicapone
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
The Study of PK, PD, Safety of Multiple Intravenous Injections of BCD-066 and Aranesp in Healthy Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      BCD-066 is a darbepoetin alfa. Clinical study BCD-066-3 is a double-blind controlled,
      randomized, parallel-group study of the pharmacokinetics, pharmacodynamics, tolerability, and
      safety of multiple intravenous injections of BCD-066 and Aranesp®.

      The purpose of the study is to confirm the equivalent pharmacokinetics, pharmacodynamics,
      safety, and tolerability of multiple IV injections of BCD-066 and Aranesp® in healthy
      volunteers.
    


Intervention name(s): BCD-066; Aranesp
Intervention type(s): Biological; Biological
Intervention description(s): BCD-066 will be administered once a week intravenously in a dose 1 µg/kg; Aranesp will be administered once a week intravenously in a dose 1 µg/kg
Other intervention name(s): darbepoetin alfa; darbepoetin alfa
Intervention MeSH terms: Darbepoetin alfa
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Other
Thorough QT Study to Evaluate the Effect of Rodatristat Ethyl, Rodatristat and Its Major Metabolites on the Heart
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      To evaluate whether Rodatristat Ethyl prolongs the QTc interval when orally administered to
      healthy volunteers.
    

Detailed description: 
      This is a Phase I, single-center, double blind, randomized, placebo- and positive-control,
      nested crossover study in approximately 64 healthy volunteers. This thorough QT/QTc study
      will be conducted to evaluate the effect of Rodatristat Ethyl on QT prolongation.
    

Intervention name(s): Rodatristat Ethyl; Moxifloxacin; Placebo for Rodatristat; Placebo for Moxifloxacin
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Oral, Tablet, 300 mg QD, 300 mg BID, 600 mg BID, 900 mg BID, 900 mg QD; Oral, Tablet, 400 mg QD; Oral, Tablet, O mg QD, 0 mg BID; Oral, Tablet, 0 mg QD
Intervention MeSH terms: Moxifloxacin; Norgestimate, ethinyl estradiol drug combination
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Stabilometry Changes After Dry Needling in Flexor Digitoum Brevis
Condition: Healthy; Foot; Dry Needling
Study type: Interventional

Summary: 
      The aim of this clinical trial is to check the balance effects of dry needling in the Flexor
      digitorum Brevis
    

Detailed description: 
      Eighteen healthy subjects wil be recruited for a quasi-experimental study. Participants will
      be from 18 to 40 years old, not obese. Participants will be measured before and after
      bilateral dry neddling in Flexor digitorum Brevis. The investigators will measure
      stabilometry variables with eyes open and closed.

      Measures. Stabilometry will be measured by displacement of the center of pressures in X and Y
      with eyes open and closed , center of pressure (COP) with eyes open and closed, COP area with
      eyes open and closed, COP antero-posterior (a-p) and medio-lateral (m-lat) directions with
      eyes open and closed, and COP speed. Two trials will be recorded for each condition and the
      order of the conditions will be randomized across subjects, eyes open and eyes closed.
    

Intervention name(s): Bilateral dry needling in latent trigger points of the Flexor digitorum Brevis Muscle
Intervention type(s): Other
Intervention description(s): Bilateral dry needling in latent trigger points of the Flexor digitorum Brevis Muscle
Intervention model: Single Group Assignment
Intervention model description: Pretest posttest of bilateral Flexor digitorum Brevis dry needling intervention
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Stabilometry; Dry needling; Trigger point
Comparative Effects of Buteyko Exercise and Corpse-Pose Technique on Cardiac Surgery Patients
Condition: Post-Cardiac Surgery Patients
MeSH terms: Cadaver
Study type: Interventional

Summary: 
      Open-heart surgeries such as coronary artery bypass grafting and valve replacements have been
      used to improve patient outcomes related to cardiac symptoms, prolongation of life, and
      health-related quality of life. Recovery from cardiac surgery is not entirely determined by
      physical attributes and medical treatment, but social and psychological factors may also
      influence the process of postoperative short and long-term recovery. The objective of this
      study is to find out the Comparative Effects of Buteyko Exercise and Corpse-Pose Technique on
      Physical Health and Quality of Life in Post-Cardiac Surgery Patients. This study will be a
      Randomized controlled trial and will be conducted in Faisalabad institute of cardiology after
      ethical approval. The study will be completed within the duration of 10 months after approval
      of synopsis. Nonprobability convenience sampling technique will be used. The sample size of
      46 patients will be taken: 25 post-cardiac surgery patients in each group with a 10%
      attrition rate. There will be two groups in this study one will be given with the Buteyko
      breathing technique and other will be provided with corpse-pose technique. Treatment protocol
      for both techniques will be 4 weeks with 3 sets per day. A pre assessment at week 1 and a
      final assessment at week 4 will be made by using SF-36 questionnaire. Data will be analyzed
      on SPSS-25.
    


Intervention name(s): Buteyko Breathing Technique; Corpse-Pose Technique
Intervention type(s): Other; Other
Intervention description(s): Group A will be treated with Buteyko Breathing Technique. Patient in a relaxed sitting position will ask to take a gentle breath in (2 sec), breath out (3sec) followed by pinching the nose with hands to hold the breath. The therapist will count the no. of seconds the patient can comfortably hold the breath until feels the need to breathe in again. Followed by releasing the nose and continue breathing.; Group B will be treated with Corpse-Pose Technique for 15-20 min.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Cardiac surgery; Buteyko breathing technique; Corpse pose; Yoga; Quality of life; Physical Health; Short-form health survey SF-36
A Bioequivalence and Food Effect Study of SEP-190 in Japanese Healthy Subjects (Study SEP 190-102)
Condition: Insomnia
MeSH terms: Sleep Initiation and Maintenance Disorders
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to investigate and evaluate the bioequivalence and food effect
      of SEP 190-102 in Japanese healthy subjects by assessing the pharmacokinetics parameters.
    


Intervention name(s): Eszopiclone 3 mg; Eszopiclone 1 mg
Intervention type(s): Drug; Drug
Intervention description(s): Group A Period I, Group B Period II:
Eszopiclone 3 mg tablet taken orally (po) with water as a single administration in the morning after fasting >=10 hours.
Except for the water taken with the drug, participants were not allowed any food/ drink from 10 hours before until 4 hours after administration of drug. Except for the water taken with the study drug, participants were not permitted to drink water from 1 hour before until 1 hour after administration of drug.
Group B Period III:
Eszopiclone 3 mg tablet taken po with water as a single administration in the morning 30 minutes after the start of breakfast.
Except for the food/ drink at breakfast and the water taken with the study drug, participants were not allowed any food or drink from 10 hours before until 4 hours after administration of the drug. Except for the food/ drink at breakfast & the water taken with the study drug, participants were not permitted to drink water from 1 hour before until 1 hour after administration.; Group A Period II, Group B Period I:
Eszopiclone three 1 mg tablets (total: 3 mg) taken orally with water as a single administration in the morning after fasting 10 or more hours.
Except for the water taken with the study drug, participants were not allowed any food or drink (except water) from 10 hours before until 4 hours after administration of the study drug. Except for the water taken with the study drug, participants were not permitted to drink water from 1 hour before until 1 hour after administration of the study drug.
Intervention MeSH terms: Eszopiclone
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Insomnia; primary insomnia; insomnia associated with psychiatric or physical disorder(s)
General Anesthetic Mode and Postoperative Complications
Condition: Anesthesia
Study type: Observational

Summary: 
      The relationship between anesthetic medication and postoperative major cardiac and cerebral
      complications will be studied using logistic regression model.
    

Detailed description: 
      The study group try to find out if there is a connection between the use of different
      anesthetic methods with different narcotic drugs and postoperative major cardiac and cerebral
      complications.
    

Intervention name(s): inhalation or propofol ,epidural or general anesthesia, remifentanil or sufentanil
Intervention type(s): Combination Product
Intervention description(s): Different combination of opioids and anesthetics
Intervention MeSH terms: Sufentanil; Remifentanil; Propofol
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        patients for non-cardiac surgery under general anesthesia
Effectiveness of the Teacher Module of the Prevention Program for Externalizing Problem Behaviour in Preschoolers
Condition: Behavior Problem of Childhood and Adolescence
MeSH terms: Problem Behavior
Study type: Interventional

Summary: 
      Investigating effectiveness of the cognitive-behavioral based teacher training under routine
      care conditions by comparison of a baseline-interval with no special intervention to a
      following interval of PEP for the kindergarten teachers only each focussing on one child (3-6
      years old) that the teacher herself indicated as "needing special attention for externalising
      behaviour". Effects on child symptoms and teachers behavior and burden within
      intervention-period are expected to be stronger than those during waiting-period.
    

Detailed description: 
      Findings of the PEP-efficacy-study based on a randomised controlled sampling ((ISRCTN
      CCT-NAPN-18918) using combined training-modules for parents and teachers showed positive
      effects on children's behaviour in the intervention-group. These effects in teacher's view
      were stronger than in the control-group but could not be proved to be statistically
      significant. Moreover after this first step of evaluation there remain unanswered questions
      concerning the stability of effects after transferring the program in routine care. Therefore
      the study is continued by an effectiveness-study.
    

Intervention name(s): PEP-TE
Intervention type(s): Behavioral
Intervention description(s): PEP-TE for kindergarten teachers of children with externalizing behaviour problems aged 3 to 6 years leads to use classical strategies of changing behaviour (defining rules, appropriate commands, positive and negative consequences) based on the "coercive interaction process" (cf. Patterson, 1982) as explanatory model for target situations. In 10 units (90-120 minutes) four to six teachers in one group develop individually tailored solutions to specified externalizing behavior problems of the target child. General strategies of improving positive interactions as well as resources and strategies for reducing stress and gaining new energy are discussed. Summary and reflection of the teacher' experiences and ideas of changes in routines prevents relapses.
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Externalizing Problem Behaviour in Preschoolers
Genetic Polymorphisms Predict Chemotherapeutic Outcomes in Patients With Metastatic Breast Cancer
Condition: Breast Neoplasm; Drug Therapy; Polymorphism,Single Nucleotide
MeSH terms: Breast Neoplasms
Study type: Observational

Summary: 
      The investigators want to research whether genetic polymorphisms of drug-metabolizing enzymes
      can be used to predict chemotherapeutic outcomes in patients with metastatic breast cancer.
    

Detailed description: 
      1. Patients evaluation On all patients a complete clinical history and physical examination
           is performed, including routine hematology and biochemistry analyses. Hematology and
           biochemistry analyses are repeated at the end of each cycle. Toxicity is classified
           according to WHO criteria at each cycle for each patient. Response is assessed after two
           cycles of chemotherapy and every two cycles thereafter, using Response Evaluation
           Criteria in Solid Tumor Group (RECIST) guidelines.

        2. Sample collection and SNP genotyping Venous blood (4 ml) is collected from each subject
           and placed into tubes containing EDTA. Genomic DNA is isolated with a DNA Blood
           isolation kit.Genotypes are performed by PCR-RFLP, PCR-DHPLC and PCR-direct sequencing,
           etc.

        3. Statistical Analysis x2 test is used to summarize the association of response and
           adverse events to chemotherapy with genetic polymorphisms.
    

Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        female patients with metastatic breast cancer
      
Biospecimen description: 
      about 4ml peripheral vein blood
    
Keywords: breast neoplasm; drug therapy; polymorphism; gene
Effect of Aspirin Vs Omega 3 Fatty Acid After Scaling and Root Planing in Type II Diabetic Patients With Chronic Periodontitis
Condition: Periodontitis; Type2 Diabetes
MeSH terms: Periodontitis; Chronic Periodontitis
Study type: Interventional

Summary: 
      The main aim and objective of this study is to compare the effectiveness of low dose aspirin
      vs omega 3 fatty acids as adjuvants to non-surgical periodontal therapy and also to evaluate
      the levels of pentraxin 3 and glycosylated haemoglobin in diabetic patients with chronic
      periodontitis
    

Detailed description: 
      There is an established bi-directional relationship between diabetes mellitus and
      periodontitis. Periodontitis causes systemic inflammation by the entry of oral pathogens and
      their virulence factors that adversely affect diabetic control in terms of elevated HbA1c
      levels.

      Host modulatory therapy (HMT) is a strategy prescribed as an adjunct to conventional
      periodontal treatment by downregulating inflammation and promoting protective or regenerative
      responses. Different drugs have been evaluated as HMT including NSAIDS, Doxycycline,
      Bisphosphonates.

      Aspirin has the unique position as HMT drug. It inhibits prostanoid production and induces
      15- epi- lipoxins which are bioactive than native lipoxins.

      Omega 3 fatty acids including Docosahexaenoic acid and Eicosapentaenoic acid due to their
      anti-inflammatory, antithrombotic, hypolipidemia and vasodilator effect, reduce the
      inflammatory mediators to levels of healthy tissues.

      Pentraxins(PTX3) are classic acute phase proteins. They are a superfamily of evolutionarily
      conserved proteins considered to be the markers of acute phase inflammation. PTX3 is also
      known as TNF stimulated gene. It is produced abundantly in periodontal tissue by neutrophils,
      fibroblasts, monocytes and epithelial cells. The plasma levels of PTX3 is raised in
      inflammatory conditions. Hence it is taken as a biomarker.
    

Intervention name(s): Scaling and root planing
Intervention type(s): Other
Intervention description(s): Scaling and root planing was done by using ultrasonic scalers with high speed suction apparatus to prevent aerosol contamination.
.
Other intervention name(s): Nonsurgical periodontal therapy
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: A total of 42 subjects participated in the study. All the subjects underwent scaling and root planning and were divided into 3 groups Group 1 - low dose aspirin ( 75 mg) once daily Group 2 - omega 3 fatty acids (500 mg) twice daily Group 3 - placebo once daily
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Novel 13C Carotenoids for Absorption and Metabolism Studies in Humans
Condition: Healthy
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Tomatoes contain several compounds which may be beneficial for human health and prevention of
      disease, although this relationship is poorly understood and very controversial. This study
      uses a new technology to study the absorption and metabolism of three different compounds
      found in tomatoes. These compounds are called: phytoene, phytofluene, and lycopene. We
      hypothesize that by studying the absorption and metabolism of these compounds, we may be able
      to understand how the compounds may influence health and disease processes.
    


Intervention name(s): Isotopically labeled lycopene, phytoene or phytofluene
Intervention type(s): Other
Intervention description(s): We will administer 10 mg of labeled carotenoid mixed with olive oil and spread on an English muffin for consumption by participants.
Intervention MeSH terms: Lycopene
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: tomato; prostate cancer; metabolism
A Study of Duloxetine (LY248686) in Japanese Children and Adolescents With Depressive Disorder
Condition: Depressive Disorder
MeSH terms: Depressive Disorder; Depression
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to determine the efficacy of duloxetine hydrochloride versus
      placebo in the treatment of Japanese children and adolescents with depressive disorder.
    


Intervention name(s): Duloxetine Hydrochloride; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Administered orally; Administered orally
Other intervention name(s): LY248686
Intervention MeSH terms: Duloxetine Hydrochloride
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Determining Serum and Urinary Levels of miRNA 192 and miRNA 25 in Patients With and Without Type 2 Diabetes.
Condition: Diabetic Kidney Disease; Type2 Diabetes
MeSH terms: Kidney Diseases; Diabetic Nephropathies; Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Observational

Summary: 
      Diabetes kidney disease (DKD) is the leading cause of end stage renal disease (ESRD) in
      western countries and its incidence is worryingly increasing worldwide. Cardiovascular
      disease shows a continuous relationship with declining of renal function in type 2 diabetes
      patients. Moreover, there is a strong evidence of all-cause mortality risk excess even in
      patients with early stages kidney disease.

      MicroRNA (miRNA) are small non-coding RNA molecules, containing 21-25 nucleotides, that
      modulate post-transcriptional gene expressions. In the past years many human miRNAs involved
      in the pathogenesis of renal disease have been discovered, such as miR-192, miR-194, miR-204
      and miR-25. Among these, miR-192 and miR-25, are receiving greater attention while it seems
      that they play a role in glomerulosclerosis and renal fibrosis. However too few data are
      available in large publish trials among patients with renal impairment and the role of serum
      and urinary levels of miR-192 and miR-25 in people with preserved renal function remain
      unclear.

      To evaluate the association between serum and urinary expression of miR-192 and miR-25 and
      renal function (according to different extent of renal impairment) in patients with or
      without type 2 diabetes.
    

Detailed description: 
      The day of the study patients undergo a routine clinical evaluation. Whole blood samples are
      collected from an antecubital vein to assess serum/plasma aliquots of 200 μl each (frozen at
      -80°C until required for quantitation) for evaluation of biochemical parameters (fasting
      glucose, HbA1c, lipid profile, serum creatinine, uric acid, electrolytes, liver function
      enzymes, albumin) and determination of serum miR-192 and miR-25.

      Two urine samples will be also collected to assess aliquots of 200 μl each (frozen at -80°C
      until required for quantitation) for determination of albumin:creatinine ratio and urine
      expression of miR-192 and miR-25.
    

Intervention name(s): no interventions required.
Intervention type(s): Other
Intervention description(s): The study does not require any interventions.
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        The study will consecutively enrolled 300 patients (200 patients with type 2 diabetes and
        100 patients without diabetes) among those referring to the Departiment of Diabetes and
        Metabolic disease, Santa Chiara Hospital, Pisa.
      
Biospecimen description: 
      Urine, serum
    
Keywords: DKD; miRNA-25; miRNA-192
Association Between Brain Stimulations for the Rehabilitation of Chronic Stroke Patients
Condition: Stroke
MeSH terms: Stroke
Study type: Interventional

Summary: 
      Cerebrovascular accident (CVA) is a cerebrovascular disease with high incidence and morbidity
      in the Brazilian population, and is considered a major cause of disability in adults. Brain
      damage caused by stroke generates a maladaptive pattern of neural activity and modulation
      between the cerebral hemispheres, unbalancing in the inter-hemispheric inhibition. This
      condition affects patient's functional recovery.

      The aim of this study is to verify the effectiveness of repetitive transcranial magnetic
      stimulation Association (rTMS) in the cortex motor contralesional, Transcranial Direct
      Current Stimulation (tDCS) in the motor cortex ipsilesional and the association between these
      two types of brain stimulations on the upper limb recovery after stroke.
    


Intervention name(s): tDCS; TMS; tDCS + TMS
Intervention type(s): Device; Device; Device
Intervention description(s): Transcranial direct current stimulation (tDCS); Transcranial magnetic stimulation; Association between tDCS and TMS.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment