bioihbjkbjnl/mcl2 huggingface dataset:
Cognitive Therapy for Recurrent Depression
Condition: Depression
MeSH terms: Depression; Depressive Disorder
Study type: Interventional
Phase: Phase 3

Summary: 
      This study determined the effectiveness of continuation phase cognitive therapy versus
      antidepressant medication in preventing relapse of depression in people with recurrent
      depression.
    

Detailed description: 
      Cognitive therapy (CT) is a short-term talking therapy that focuses on changing negative
      thinking patterns and helping patients develop coping skills to deal with their experiences.
      Evidence suggests that CT is effective in treating a number of psychiatric conditions,
      including anxiety and anger. This study will determine the effectiveness of cognitive therapy
      versus antidepressant medication or placebo in preventing relapse of depression in people
      with recurrent depression.

      This study lasted approximately 36 months and comprised three phases. For the first 12 weeks,
      all participants received between 16 and 20 CT sessions. Participants were then randomly
      assigned to receive additional CT sessions, antidepressants, or placebo for an additional 8
      months. Upon completing treatment, participants entered follow-up study visits once every 4
      months for the next 24 months. Clinician-rated scales and questionnaires were used to assess
      depressive symptoms of participants at study start and at the end of each study phase.
    

Intervention name(s): Continuation phase cognitive therapy; Continuation phase fluoxetine; Continuation phase pill placebo; Acute phase cognitive therapy
Intervention type(s): Behavioral; Drug; Other; Behavioral
Intervention description(s): Continuation phase cognitive therapy included 10 sessions over 8 months.; The dosage of fluoxetine was increased to 40 mg over 8 months.; The dosage of pill placebo was increased to 40 mg over 8 months.; For the first 12 weeks, all participants received between 16 and 20 cognitive therapy sessions.
Other intervention name(s): Prozac
Intervention MeSH terms: Fluoxetine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Cognitive therapy; Antidepressants; Psychotherapy
Diaphragmatic Thickness and Functional Exercise Capacity in Lobectomy Surgeries With Thoracotomy and VATS
Condition: Video Assisted Thoracoscopic Surgery; Thoracic Surgery; Respiratory Muscles
Study type: Observational

Summary: 
      The most commonly treatment for early stage non-small cell lung cancer (NSCLC) is lobectomy.
      Different surgical interventions during lobectomy are thought to have different effects on
      respiratory functions and exercise capacities. The aim of this study was to evaluate
      respiratory muscle strength, functional exercise capacity, and diaphragmatic thickness in
      groups that underwent lobectomy with standard thoracotomy, muscle sparing thoracotomy, and
      video-assisted thoracic surgery (VATS).
    

Detailed description: 
      The most commonly treatment for early stage non-small cell lung cancer (NSCLC) is lobectomy.
      Different surgical interventions during lobectomy are thought to have different effects on
      respiratory functions and exercise capacities. The aim of this study was to evaluate
      respiratory muscle strength, functional exercise capacity, and diaphragmatic thickness in
      groups that underwent lobectomy with standard thoracotomy, muscle sparing thoracotomy, and
      video-assisted thoracic surgery (VATS). In this study we will evaluate respiratory muscle
      strength, functional exercise capacity, diaphragmatic thickness, postoperative pulmonary
      complications, pain, dyspnea, pulmonary function, functional status, anxiety and depression.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Individuals with lung cancer who met the inclusion criteria in the 18-75 age range
        participated in the study. According to the surgical intervention methods, the patients in
        our study; divided into three groups as standard thoracotomy, muscle sparing thoracotomy,
        and VATS.
      
Keywords: Lung cancer, functional capacity
Celgosivir as a Treatment Against Dengue
Condition: Dengue Fever
MeSH terms: Dengue; Fever
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This is a Randomized, Double-Blind, Placebo-Controlled, Phase 1b Clinical Study to Evaluate
      the Activity, Pharmacokinetics, Safety and Tolerability of Celgosivir in Adults with
      Confirmed Dengue Fever.
    

Detailed description: 
      Patients with confirmed dengue fever who meet all inclusion and exclusion criteria will be
      enrolled and admitted to the Investigational Medicine Unit. Patients will be randomized 1:1
      to celgosivir or placebo. Capsules of placebo or celgosivir will be administered for 5 days.
      While in hospital, daily clinical exams will be conducted, and blood samples will be
      collected for viral load, quantitative NS1, hematology, clinical chemistry, cytokine levels
      and pharmacokinetics (PK). Safety assessments will be conducted. At discharge on Study Day 5,
      patients will be asked to return on Study Days 7, 10, and 15 for blood sampling and safety
      assessments.
    

Intervention name(s): celgosivir; placebo
Intervention type(s): Drug; Drug
Intervention description(s): 100 mg capsules, 400 mg loading dose 200 mg bid; Capsules of identical appearance containing starch
Other intervention name(s): Bu-Cast
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Clinical Trial to Assess the Safety and Pharmacokinetics of HUG116 Tablet and Viread® Tablet in Healthy Male Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      A randomized, open-label, single-dosing, 2x2 crossover study to compare the safety and
      pharmacokinetics of HUG116 tablet(Tenofovir Disoproxil) with Viread® tablet(Tenofovir
      Disoproxil Fumarate) in healthy male volunteers
    


Intervention name(s): Viread® tablet 300mg; HUG116 tablet 245mg
Intervention type(s): Drug; Drug
Intervention description(s): Single dose administration(PO) in the fasted state; Single dose administration(PO) in the fasted state
Intervention MeSH terms: Tenofovir
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Multi-Center Study Comparing Efficacy and Safety of Frequently Modified Insulin Therapy
Condition: Diabetes Mellitus, Type 2; Hypoglycemia
MeSH terms: Diabetes Mellitus, Type 2; Hypoglycemia
Study type: Interventional

Summary: 
      Hygieia Research seeks to conduct a prospective randomized clinical study involving adult
      subjects with uncontrolled Type-2 diabetes requiring insulin. The study seeks to demonstrate
      that the clinical application of the d-Nav will achieve metabolic control in a safe and
      effective manner.
    

Detailed description: 
      The purpose of this study is to demonstrate that the use of d-Nav (d-Nav group) is superior
      to titration of insulin dosage relying on data from glucose meters with health care provider
      support (Control) in the management of insulin treated diabetes, by randomizing 200 insulin
      treated subjects with type 2 diabetes.

      Primary Objective: To demonstrate a greater reduction in HbA1c at 6-months for d-Nav users
      compared to control patients in the primary cohort.
    

Intervention name(s): d-Nav; Blood Glucose Monitoring System
Intervention type(s): Device; Device
Intervention description(s): Insulin dosage is adjusted as required; Insulin dosage is adjusted as required
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Clinical Study to Compare Dental Plaque Control
Condition: Dental Plaque
MeSH terms: Dental Plaque
Study type: Interventional
Phase: Phase 3

Summary: 
      This clinical study was to evaluate the control of dental plaque formation after
      toothbrushing for 4 days with each of the 4 study toothpastes.
    

Detailed description: 
      Evaluation of dental plaque control for two prototype toothpastes will be determined by
      comparison to two control toothpastes.
    

Intervention name(s): Fluoride; Triclosan/Fluoride; Triclosan/Fluoride; Triclosan/Fluoride
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Brush two times a day for 4 days.; Brush two times daily for 4 days; Brush twice daily for 4 days; Brush twice daily for 4 days
Other intervention name(s): monofluorophosphate; sodium fluoride; triclosan; sodium fluoride; triclosan; amino acid; sodium fluoride; triclosan; amino acid/bicarbonate
Intervention MeSH terms: Listerine; Triclosan; Fluorides; Sodium Fluoride; Fluorophosphate
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Enteroprotein Modified Fast ( EMF )
Condition: Obesity
MeSH terms: Obesity
Study type: Observational

Summary: 
      The purposes of the esperience is:

        1. to verify the safety of protein sparing modified fast(PSMF) by enteral route ( EMF
           )performed in cycles of ten days/months for six months

        2. to compare EMF with oral PSMF clinically ( appetite control, fat freemass mantainance,
           polmonary function tests and metabolic pattern)

        3. to verify the weight mantainance after 6 months from the treatment suspension
    

Detailed description: 
      Rationale A) primary endpoint

        1. to verify the safety of protein sparing modified fast by enteral route ( EMF )in cycles
           of ten days/months repeated for six months,

        2. To compare EMF with oral PSMF clinically ( appetite control, polmonary function tests
           and metabolic pattern) and on metabolic parameters (hypertension, glucose intolerance,
           dyslipidaemia) maintaining body composition (particularly fat free mass and muscular
           strength) in 15 patients with disease-causing obesity not responding to medical
           treatment and/or cognitive/behavioural therapy, who are candidates for invasive
           treatment such as the gastric balloon or surgery but do not intend to undergo them
           compared with 15 undergoing the same regimen without the naso-gastric tube. To verify
           the effects of treatment with regard to the enteral-hormonal structure during the acute
           phase (selected sub-group) and while undergoing treatment.

      B) Secondary endpoints:

        1. To verify the percentage of patients who maintain the weight reached 6 months after
           stopping treatment with the naso-gastric tube associated with a high-calorie
           normal-protein diet.

        2. Verify clinical safety of EN in these patients.
    

Intervention name(s): enteral protein tube feeding in obese
Intervention type(s): Procedure
Intervention description(s): The intervention is represented by a new alternative to treat obese patients by means of a protein sparing modified fast administered by continous 24 h enteral feeding
Other intervention name(s): EMF ( enteral modified fast )
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        patients with BMI 30 - 45 Kg/m2
      
Keywords: obesity; PSMF ( protein sparing modified fast); Enteral nutrition; Tube feeding; VLCD ( very low calorie diet); Pulmonary function tests; body composition; FFM ( fat free mass); Body fat; Handgripstregth
Effectiveness of Routine Physical Therapy With Intensive Bimanual Training in Cerebral Palsy Children
Condition: Cerebral Palsy
MeSH terms: Paralysis; Cerebral Palsy
Study type: Interventional

Summary: 
      Effectiveness of Routine Physical Therapy With or Without Home Based Intensive Bimanual
      Training on Clinical Outcomes in Cerebral Palsy Children
    

Detailed description: 
      Cerebral Palsy is one of the most common issue seen in pediatric rehabilitation .Home based
      intensive Bimanual training has proven to be one of the most effective rehabilitation
      training for improving motor. The study determines the effectiveness of routine physical
      therapy with or without home-based intensive bimanual training on coordination of hands and
      daily activities of daily living. A nine months randomized control trial was comprised of
      thirty children with unilateral spastic cerebral palsy aged between 4 to 7 years. One group
      received routine physical therapy and the other group received a goal specific bimanual
      training from their parents in their home setting for 3.5 hours per week for 6 weeks
      according to a modified set up. Follow up sessions were done at 6th week. Activities of daily
      living and coordination were measured using Pediatric motor log activity scale and ABILHAND
      respectively.
    

Intervention name(s): home based intensive bimanual training; Routine Physical Therapy
Intervention type(s): Other; Other
Intervention description(s): Home Based Intensive Bimanual Training with Routine Physical Therapy bimanual training includes. functional activities play with ball, make a dough, make beads, make blocks .Routine Physical Therapy includes stretching spastic muscles, EMS, normalizing muscle tone.; Routine physical Therapy includes stretching spastic muscles, EMS, normalizing muscle tone.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Home Based Intensive Bimanual training
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Cerebral Palsy; Bimanual Training
Study Evaluating the Efficacy and Safety of Remifentanil in a Rapid Sequence Induction for Fragile Subjects
Condition: Tachycardia
MeSH terms: Tachycardia
Study type: Interventional
Phase: Phase 4

Summary: 
      The primary objective is to determine whether, during a rapid sequence intubation by
      etomidate, and succinylcholine Sellick maneuver, the administration of remifentanil at 2
      different dosages (0.5 and 1.0 microgram per kg body weight), reduces potentially dangerous
      reactional tachycardia.
    


Intervention name(s): 0.5 µg/kg remifentanil; 1.0 µg/kg remifentanil; NaCl
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 0.5 µg/kg remifentanil is used during induction in addition to the classic induction protocol; 1.0 µg/kg remifentanil is added to the classic induction anesthesia protocol; an equivalent volume (1 ml for 10 kg of weight) of 0.9% isotonic NaCl is injected in addition to the classic anesthesia induction protocol
Intervention MeSH terms: Remifentanil
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: remifentanil; anesthesia induction; reactional tachycardia
Plasmalyte-148 Solution and Blood Coagulation
Condition: Blood Coagulation Disorder
MeSH terms: Hemostatic Disorders; Blood Coagulation Disorders
Study type: Observational

Summary: 
      Fluids administered intravenously may alter whole blood coagulation. However, little is known
      about the dose-response relationships of hemodilution in plasmalyte-148 solution.
      Investigators have therefore performed the present study to measure the effect of a
      plasmalyte-148 solution on the coagulation pathway according to the hemodilution level using
      a rotational thromboelastometry (ROTEM®) tests.
    


Intervention name(s): Plasmalyte-148
Intervention type(s): Other
Intervention description(s): Venous blood is taken from 12 healthy volunteers and divided into four specimen bottles, which were diluted with different levels (0%, 20%, 40%, and 60%) using a plasmalyte-148 solution.
Intervention MeSH terms: Plasma-lyte 148
Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Healthy volunteers
Pharmacokinetics and Safety of Gadopiclenol in Japanese Healthy Volunteers
Condition: Pharmacokinetics
Study type: Interventional
Phase: Phase 1

Summary: 
      This single center, single ascending dose, double blind, randomized, placebo-controlled phase
      I trial will include male and female Japanese healthy volunteers. Within a 4-week run-in
      period before inclusion in the trial, healthy volunteers will be checked for
      inclusion/non-inclusion criteria and will then be randomized and administered with
      gadopiclenol or placebo. For each healthy volunteer, there will be a confinement period of
      one night before the inclusion visit and 2 days post administration at the clinical unit. The
      healthy volunteers will return to the clinical unit for safety visit 7 days after study
      product administration.

      In each dose group, 6 healthy volunteers (3 male and 3 female) will receive gadopiclenol and
      3 healthy volunteers (2M/1F or 1M/2F) will receive placebo (physiological saline solution,
      0.9% sodium chloride) in one single intravenous administration.

      Dose escalation from one group to the next group will be sequential and will be allowed only
      if the clinical and biological safety of all healthy volunteers from the previous tested dose
      is acceptable. The decision will be made by a Trial Safety Review Board (TSRB), consisting in
      members of Guerbet team and the principal investigator.
    


Intervention name(s): gadopiclenol; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): administration by intravenous (IV) bolus injection at 2 mL/s rate without dilution, followed by a saline flush of at least 5 mL at the same rate to ensure complete injection of the contrast agent.The gadopiclenol administration is performed by power injecto; intravenous (IV) bolus injection at 2 mL/s, followed by a saline flush of at least 5 mL to be in the same conditions as for gadopiclenol administration.The gadopiclenol administration is performed by power injector
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Other
Intensive Neurorehabilitation for Cerebral Palsy
Condition: Cerebral Palsy
MeSH terms: Cerebral Palsy
Study type: Interventional

Summary: 
      Evaluation of effects of Intensive Neurophysiological Rehabilitation System in children with
      cerebral palsy in a single-blinded randomized controlled trial with two groups.
    

Detailed description: 
      Intensive Neurophysiologic Rehabilitation System (INRS) is an intensive multimodal
      rehabilitation system, whereby versatile and multi-faceted methods are combined with the aim
      of improvement of functioning and quality of life of children with CP. Treatment components
      are addressing different functional goals in the Body Functions domain of the International
      Classification of Functioning (joint mobility, muscle tone, voluntary movement, pain,
      intellectual functions) and Activities and Participation domains (fine hand use, walking,
      moving around, interpersonal interactions and family relationships.

      The Intensive correction course includes up to four hours of daily training. The treatment
      program is tailored individually according to the patient's condition and incorporates some
      of the following component according to individual indications and contraindications:
      Physical therapy, Occupational therapy, Full body massage, Spinal manipulative therapy, Joint
      mobilization techniques, Paraffin and wax applications, Reflexotherapy, Strength training,
      Computer game therapy, Suit therapy, Vibration therapy, Treadmill training, Group session of
      "rhythmic gymnastics". The influence of one technique complements and potentiates other
      rehabilitation components.

      The aim of the study is to evaluate effects of Intensive Neurophysiological Rehabilitation
      System in children with cerebral palsy in a randomized controlled trial.

      A single-blinded randomized controlled trial with two groups will be conducted. The
      experimental group will undergo treatment course according to INRS, control group will
      continue receive usual home activity and care while staying on the waiting list. To avoid
      possible information leak about patient group allocation, the study should be performed in
      two independent centers: Evaluation center and Treatment center. Assessments will be
      conducted three times: at the baseline, in 3 weeks, and 7 weeks after the baseline.
    

Intervention name(s): Intensive Neurophysiological Rehabilitation System; Activity and care as usual
Intervention type(s): Procedure; Procedure
Intervention description(s): Intensive Neurophysiological Rehabilitation System (INRS) is a multicomponent approach that consists of different treatment modalities.; Control group continues usual activity and care while staying in the waiting list.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Rehabilitation; Motor skills; Activities of Daily living