bioihbjkbjnl/mcl2 huggingface dataset:
Clinical Trial of Robot-assisted-gait-training (RAGT) in Stroke Patients
Condition: Stroke
MeSH terms: Stroke
Study type: Interventional

Summary: 
      A clinical trial of robot-assisted-gait-training (RAGT) in stroke patients to evaluate its
      efficacy, safety over conventional gait training.
    

Detailed description: 
      Robot-assisted-gait-training (RAGT) in stroke patients to evaluate its efficacy, safety over
      conventional gait training.

      Experimental group receives robot-assisted-gait-training and conventional gait training.

      Active comparator group receives conventional gait training only as the same number as the
      experimental group.
    

Intervention name(s): Walkbot; Conventional physical therapy
Intervention type(s): Device; Device
Intervention description(s): Walkbot(robot assisted gait training) 30 minutes and conventional physical therapy 30 minutes each per day to be administered 5 times a week for 3 weeks.; Conventional physical therapy 30 minutes to be administered twice a day, 5 times a week for 3 weeks.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Stroke
Randomized, Controlled Trial of Kangaroo Mother Care in Increasing the Rate of Weight Gain Among Neonates
Condition: Low Birth Weight Among Neonates
MeSH terms: Body Weight; Birth Weight; Weight Gain
Study type: Interventional
Phase: Phase 3

Summary: 
      A randomized, controlled trial of Kangaroo Mother Care (KMC) to determine the effectiveness
      in increasing the rate of weight gain among low birth weight neonates.
    

Detailed description: 
      A randomized, controlled trial of Kangaroo Mother Care (KMC) versus Conventional Care to
      determine the effectiveness of KMC in increasing the rate of weight gain among low birth
      weight neonates and if it will decrease sepsis rate and shorten hospital stay among the
      group.
    

Intervention name(s): Kangaroo Mother Care; Conventional Mother Care
Intervention type(s): Procedure; Procedure
Intervention description(s): The infants were placed on continuous skin to skin contact between the mother and the baby as soon as possible. The mother kept her newborn infant between the breast, in close contact with her body and covered with the kangaroo tube. Infants wore diaper and a cap during the procedure. Breastfeeding was the standard feeding method.
When the baby was not in KMC, the baby was placed in the bassinet under warm lamp, if needed, adequately clothed and covered.; This is generally included: an artificial warming system (heated room overhead lamp warmers). Breastfeeding was also the standard feeding method but if indicated, babies can also be fed through tube or cup feeding. The mothers were allowed to visit their babies anytime but skin to skin contact was not allowed.
Babies in both groups were monitored hourly. Their heart rate, respiratory rate and temperature were monitored and recorded. Any untoward events like hypothermia, hypoglycemia, apnea, signs of sepsis, and feeding problems were also noted.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Kangaroo Mother Care(KMC), Low-birth weight, neonates
Bioequivalence Between Single Administration of ASC-01 (Aripiprazole/Sertraline Combination Drug) and Concomitant Single Administration of Aripiprazole and Sertraline, and Food Effect on Pharmacokinetics of ASC-01 in Healthy Male Adults
Condition: Healthy Male Adults
Study type: Interventional
Phase: Phase 1

Summary: 
      To investigate the bioequivalence of aripiprazole between administration of one ASC-01 tablet
      (aripiprazole 3 mg/sertraline 100 mg combination drug) and concomitant administration of one
      aripiprazole 3-mg tablet and two sertraline 50-mg tablets (Cohort 1).

      To investigate food effect on plasma pharmacokinetics of aripiprazole and sertraline by
      single oral administration of ASC-01 under a fasting or fed condition (Cohort 2).
    


Intervention name(s): ASC-01; Aripiprazole and sertraline
Intervention type(s): Drug; Drug
Intervention description(s): Aripiprazole 3 mg/sertraline 100 mg combination drug; Aripiprazole 3 mg and sertraline 100 mg
Intervention MeSH terms: Aripiprazole; Sertraline
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
VALID : VAlproate Versus LIthium in Bipolar Disorders
Condition: Bipolar Disorder
MeSH terms: Bipolar Disorder
Study type: Interventional
Phase: Phase 4

Summary: 
      Primary Objective :

        -  To compare the efficacy of valproate to lithium in Bipolar I patients suffering from a
           manic or a mixed episode according to DSM IV TR (APA 2000) [Diagnostic and Statistical
           Manual of Mental Disorders (DSM) fourth edition (IV)Text Revision (TR)] and over a
           periode of 3 weeks and 12 weeks of treatment

      Secondary Objective :

        -  To evaluate the clinical and biological safety of valproate compared to lithium.
    


Intervention name(s): Valproate sodium
Intervention type(s): Drug
Intervention MeSH terms: Valproic Acid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Multicenter, Prospective, Non-randomized, Single-arm, Interventional Study for the Evaluation of the Safety and Preformance of the SRS Device for the Treatment of Pelvic Organ Prolapse
Condition: Anterior Vaginal Wall Prolapse With/Without Apical/Uterine Descent
MeSH terms: Prolapse
Study type: Interventional

Summary: 
      A prospective, single arm, multi-center clinical study to evaluate the safety and performance
      of the SRS (Lyra Medical) vaginal mesh in POP patients
    

Detailed description: 
      The SRS implant is intended for transvaginal surgical treatment of anterior vaginal wall
      prolapse with or without vaginal apex/uterine prolapses
    

Intervention name(s): SRS - Self Retaining Support system
Intervention type(s): Device
Other intervention name(s): transvaginal surgical treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Salty Life 7 Study: Effect of High Salt Intake on Several Physiological Systems in Immobilisation
Condition: Bone Metabolism; Electrolyte Metabolism; Acid-Base Metabolism; Energy Metabolism; Circulation System
Study type: Interventional

Summary: 
      The Salty Life 7 study aimed to examine the effect of a high salt (sodium chloride, NaCl)
      intake on different forms of sodium retention, acid-base balance and bone metabolism and
      other influenced physiological systems. Because of the fact that astronauts are a vulnerable
      group in this context, they were of special interest. Astronauts have a high salt intake,
      probably because of a reduced sense of taste, as well as an increased bone resorption
      resulting from the lowered mechanical load in space. In which forms sodium could be retained
      even without fluid retention (osmotically inactive)- contrary to the argumentation of
      physiological text books - and if the acid-base balance is connected to sodium chloride
      induced bone loss is examined in a stationary bed rest study with 8 healthy, young, male test
      subjects. The study consisting of 2 x 21 days is carried out at the German Aerospace Center
      (DLR). After an adaptation period of 4 days, test subjects are immobilised in 6° head-down
      tilt bed rest (simulation model for some physiological changes in space) for 14 days during
      which they received a high (7.7 mmol NaCl/kgBW/d) and a low salt (0.7 mmol NaCl/kgBW/d)
      intake in cross-over design. The form of sodium retention is investigated by the calculation
      of daily metabolic sodium-, water- and potassium balances and by changes in body weight. The
      measurements of bone formation (bAP, PINP, Osteocalcin) markers as well as bone resorption
      markers (CTX, NTX) supply insight into the influences of a high salt intake on bone
      metabolism. Blood gas analysis and ph values of 24-h urine are used to gather information
      about accompanying changes in the acid-base balance. Further physiological systems like
      energy metabolism and circulation system are also under investigation.
    


Intervention name(s): Dietary salt intake
Intervention type(s): Other
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: bone metabolism; salt intake; acid base balance; bed rest
Comparing the Aesthetic Results of Two Common Incisions in External Rhinoplasty
Condition: Cosmetic Outcome
Study type: Interventional
Phase: Phase 3

Summary: 
      There was not any randomize trial to show what is the best type of incision in open
      rhinoplasty. So, we use both self-rating by patients ,independent physician observers Visual
      Analogue Scale (VAS) and also a validated scar analysis to compare inverted V and stair step
      incisions.
    

Detailed description: 
      Approaches to rhinoplasty can be separated into two broad categories: external and endonasal,
      which each of them their own proponent. However, the external approach provide better
      exposure, critics against this technique is often due to cosmetic deformity regarding the
      incision. Hence, over the recent years surgeons have modified the trans-columellar incision
      into two big categories: gull wing and stair steps. While each of them has its own
      proponents, there is no randomized trial, comparing their cosmetic results.

      There was not any randomize trial to show what is the best type of incision in open
      rhinoplasty. So, we use both self-rating by patients ,independent physician observers Visual
      Analogue Scale (VAS) and also a validated scar analysis to compare inverted V and stair step
      incisions.
    

Intervention name(s): inverted V incision; stair step incisions
Intervention type(s): Procedure; Procedure
Intervention description(s): It is a type of incision; It is a type of incision
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Diabetes-specific Formula (DSF) in Individuals With Type 2 Diabetes
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      A randomized, controlled, crossover design with three treatments to determine the effects of
      diabetes-specific formula on glycemic control in individuals with type 2 diabetes.
    


Intervention name(s): DSF; Breakfast 1; Breakfast 2
Intervention type(s): Other; Other; Other
Intervention description(s): Diabetes-specific formula; Noodle Soup; Glutinous rice
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
A Pilot Study to Evaluate the Efficacy and Safety of Ariva® Silver Wintergreen in Healthy Smokers
Condition: Tobacco Use Disorder; Smoking
MeSH terms: Tobacco Use Disorder
Study type: Interventional
Phase: Phase 1

Summary: 
      Study to determine the safety and effectiveness of silver salt in Ariva® Silver Wintergreen
      Lozenge on discouraging smoking, by its imparting an unfavorable taste to the smoker when
      tobacco is smoked.
    

Detailed description: 
      Each subject will be given an Ariva® Silver Wintergreen lozenge or an Ariva® Wintergreen
      lozenge on a random basis.

      Once the lozenge has dissolved in the mouth, subjects will smoke one of their own cigarettes,
      and will answer questions about the experience and their craving for a cigarette.

      After a washout period, each subject will repeat the steps with the second type of lozenge.
    

Intervention name(s): Ariva Silver Wintergreen; Ariva Wintergreen
Intervention type(s): Other; Other
Intervention description(s): Study product containing 6 mg silver salt and 2 mg nicotine per dissolvable lozenge, administered orally as a single dose.; Comparator product, a compressed dissolvable smokeless tobacco lozenge containing 2 mg nicotine administered orally as a single dose.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Keywords: smoking; smokeless; aversion; nicotine; nicotine replacement
Remote Monitoring of Diabetes in Young Children With Type 1 Diabetes
Condition: Type 1 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional

Summary: 
      The primary objective of this project is to examine the impact of a continuous glucose
      monitoring (CGM) intervention on health and psychological outcomes in young children with
      type 1 diabetes (T1D).
    


Intervention name(s): Developmental Demands; Distress Reduction; Remote Monitoring; Fear of Hypoglycemia; No intervention
Intervention type(s): Behavioral; Behavioral; Behavioral; Behavioral; Behavioral
Intervention description(s): Education and training related to use of CGM in this age group; Education and training on reducing distress; Education and training on the use of remote monitoring; Education and training on reducing fear of hypoglycemia; No intervention - serves as the control group
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Study to Evaluate VIB7734 in Participants With Systemic Lupus Erythematosus (SLE), Cutaneous Lupus Erythematosus (CLE), Sjogren's Syndrome, Systemic Sclerosis, Polymyositis, and Dermatomyositis
Condition: Systemic Lupus Erythematosus; Cutaneous Lupus Erythematosus; Sjogren's Syndrome; Systemic Sclerosis; Polymyositis; Dermatomyositis
MeSH terms: Sjogren's Syndrome; Dermatomyositis; Polymyositis; Lupus Erythematosus, Systemic; Scleroderma, Systemic; Scleroderma, Diffuse; Lupus Erythematosus, Cutaneous; Syndrome; Sclerosis
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the safety and tolerability of escalating, multiple
      subcutaneous (SC) doses of VIB7734 in participants with Systemic Lupus Erythematosus (SLE),
      Cutaneous Lupus Erythematosus (CLE), Sjogren's Syndrome, Systemic Sclerosis, Polymyositis,
      and Dermatomyositis.
    

Detailed description: 
      This study will have 3 periods: screening, treatment period, and extended follow-up. The
      screening period is 28 days. A total of 32 participants will be enrolled in 3 cohorts with 8
      participants in Cohort 1, and 12 participants each in Cohorts 2 and 3. In Cohort 1,
      participants will be randomized in a 3:1 ratio to receive VIB7734 or matching placebo by
      injection every 4 weeks (q4w) for a total of 3 doses on Days 1, 29, and 57. In Cohorts 2 and
      3, participants diagnosed with lupus only will be randomized in a 2:1 ratio to receive
      VIB7734 or matching placebo by injection q4w for 3 doses on Days 1, 29, and 57. Participants
      will be followed until at least Day 141. After the Day 141 visit, participants will exit the
      study if participants meets adequate plasmacytoid dendritic cells (pDCs). If an adequate pDC
      level does not meet at Day 141 visit, the participant will continue the follow-up for pDC
      repletion until they meet the protocol defined adequate pDC level or Day 337 visit has been
      reached.
    

Intervention name(s): VIB7734; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Participants will receive VIB7734 via injection.; Participants will receive placebo matching to VIB7734 via injection.
Other intervention name(s): MEDI7734
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
To Compare Safety and Pharmacokinetic Properties of CJ-30039 and Lipidil Supra
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      To investigate the safety and pharmacokinetic properties of CJ-30039 and Lipidil Supra
    

Detailed description: 
      Study objectives

        -  To compare the safety and pharmacokinetic properties of CJ-30039 and Lipidil Supra after
           a single oral administration in healthy male volunteers.

        -  To evaluate the food-effect on pharmacokinetics of CJ-30039 after a single oral
           administration in healthy male volunteers.
    

Intervention name(s): CJ-30039; fenofibric acid
Intervention type(s): Drug; Drug
Intervention description(s): single dose; single dose
Other intervention name(s): Incrementally Modified Drugs of fenofibric acid; Greencross Lipidil Supra 160mg
Intervention MeSH terms: Fenofibric acid; Fenofibrate
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Safety; Pharmacokinetics
Impact of NMES on Spirometry Values, Functional Capacity and Quality of Life in Patients With Pulmonary Hypertension
Condition: Pulmonary Hypertension
MeSH terms: Hypertension, Pulmonary; Hypertension
Study type: Interventional

Summary: 
      Pulmonary hypertension (PH) features symptoms related to a decreased cardiac autonomic
      response, pulmonary function and exercise capacity.

      Non-pharmacological interventions are low cost and can significant enhance outcomes in these
      patients. Neuromuscular electrical stimulation (NMES) has been proposed as a viable
      therapeutic approach in patients with functional limitations, particularly those that present
      with difficulty to perform exercise protocols.

      Objective: to evaluate the impact of NMES on exercise capacity, spirometry values and quality
      of life of patients with PH.

      Material and methods: prospective randomized controlled study with a control group (GC, n9)
      and NMES goup (GE, n8). Quality of life and exercise capacity through the six-minute walk
      test (6MWT) were assessed before and after the NMES protocol.

      Results: the GE presented with a significant improvement in distance walked in the 6MWT,
      cycle ergometry, spirometry and quality of life in the areas of vitality, emotional and
      social aspects of the questionnaire Short Form Health Survey-36.

      Conclusion: NMES is a useful tool in the treatment of patients with PH, resulting in improved
      exercise capacity, quality of life and lung function testing.
    


Intervention name(s): Neuromuscular Electrical Stimulation
Intervention type(s): Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: pulmonary hypertension; peripheral muscle electrostimulation; capacity of the exercises; quality of life
Efficacy of Belatacept in Reducing DSA
Condition: Kidney Transplantation
Study type: Interventional
Phase: Phase 4

Summary: 
      The primary objective of this study is to demonstrate that administration of belatacept in
      maintenance kidney transplant recipients may cause a reduction in Donor Specific HLA Antibody
      (DSA).
    

Detailed description: 
      The aim of this study is to evaluate patients converted to belatacept in combination with
      Mycophenolate Mofetil (MMF) with corticosteroids with respect to their DSA titer. Patients in
      this study will be converted from their calcineurin inhibitor (CNI) to belatacept from
      baseline in an attempt to down-modulate antibody production by B-cells. Dosing will be
      calculated per prescribing information for dosing maintenance phase (5mg per kg every 28
      days.
    

Intervention name(s): Belatacept
Intervention type(s): Drug
Intervention description(s): Patients will be converted from their MMF to Belatacept
Intervention MeSH terms: Abatacept
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Effect of Lower Back Treatment in People With Patellofemoral Pain Syndrome.
Condition: Patellofemoral Pain Syndrome
MeSH terms: Patellofemoral Pain Syndrome; Syndrome; Somatoform Disorders
Study type: Interventional

Summary: 
      The purpose of this study is to determine if a lower back treatment would change the knee
      pain intensity and the level of functional activities as well as the muscle activities in
      people with anterior knee pain. The investigators hypothesized that the lower back treatment
      may change the hip and knee muscle activities as well as reduce the knee pain intensity and
      improve the functional activities in people with anterior knee pain.
    


Intervention name(s): Lumbopelvic Manipulation; Passive lumbar spine flexion and extension
Intervention type(s): Other; Other
Intervention description(s): High-velocity low-amplitude non-specific lumbopelvic thrust manipulation; Passive lumbar spine flexion and extension without reaching the physiological end feel for 1 min from a side lying position.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Multicentric Study VATS Major Introperative Complications
Condition: Lung Neoplasms
MeSH terms: Lung Neoplasms
Study type: Observational

Summary: 
      This study investigates the most common major complications that result in unplanned
      additional surgery in patients undergoing vats anatomical resections. Several high-volume
      European centres participate. The purpose is to quantify these major complications, discuss
      the steps that can be taken to prevent these events, how they can be dealt with, be it by
      vats or conversion
    

Detailed description: 
      Vats lobectomy is becoming the standard of care for early stage lung cancer. Several studies
      have shown feasibility and safety in dedicated centres. Compared to thoracotomy the procedure
      results in at least equal oncologic results and survival, perhaps better.

      Most series do not publish their early experience. They are retrospective and report on
      lobectomies and segmentectomies, excluding the live-saving pneumonectomies. They are
      potentially ignoring the intention-to-treat principle, excluding conversions.

      Based on scarce existing literature and conference worst-case presentations a pattern of the
      most common intraoperative major complications can be drawn In Europe, a large percentage of
      high-volume-centres have now successfully implemented a vats lobectomy program. In this era
      with low-volume-centres switching into vats anatomical resections, it is important to focus
      on potentially life-threatening complications. To be aware of potential hazards is the best
      way to avoid them.
    

Observational model: Cohort
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        All patients intended to undergo a vats anatomical resection
      
Keywords: Thoracic Surgery, Video-Assisted