bioihbjkbjnl/mcl2 huggingface dataset:
Green Tea Extracts for Mild-to-moderate Diabetic Peripheral Neuropathy
Condition: Diabetic Peripheral Neuropathy
MeSH terms: Peripheral Nervous System Diseases; Diabetic Neuropathies
Study type: Interventional

Summary: 
      the present randomized placebo-controlled study aimed to evaluate the effect of green tea
      extract administration on the clinical and neurophysiological parameters in patients with
      mild-to-moderate diabetic peripheral neuropathy.
    


Intervention name(s): Green tea; Placebo
Intervention type(s): Dietary Supplement; Other
Intervention description(s): Green tea extract capsules; Placebo containing inert material.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Insole-based Visual Biofeedback for Weight-bearing in Total Hip Replacement
Condition: Total Hip Replacement; Visual Biofeedback; Weight Bearing
MeSH terms: Body Weight
Study type: Interventional

Summary: 
      The study investigates the effects of visual biofeedback, based on a sensorized system for
      the dynamic evaluation of the plantar pressure versus rehabilitation with traditional verbal
      instructions of the physiotherapist, on weight bearing distribution in patients who underwent
      first total hip replacement. The study is a randomized controlled trial, with parallel
      groups, without blinding.
    

Detailed description: 
      Forty patients, who underwent first total hip replacement surgery were enrolled and divided
      into two groups on second postoperative day. Experimental group followed the training wearing
      sensorized insoles that provided plantar pressures and shift of foot center of pressure
      images on three monitors. Control Group followed verbal instructions of physiotherapist
      during training. From 4th to 10th postoperative day both groups followed the same
      rehabilitation program including exercises to restore correct weight bearing.
    

Intervention name(s): Visual biofeedback with the use of sensorized insoles; Standard rehabilitation based on physiotherapist's verbal instructions
Intervention type(s): Device; Other
Intervention description(s): Between the 4th and the 10th day post surgery, both groups performed the same rehabilitation protocol. The experimental group was re-educated to the correct gait dynamics by wearing the sensorized insoles and by using a specific software's graphical interface as a visual biofeedback.; Between the 4th and the 10th day post surgery, both groups performed the same rehabilitation protocol.The Control group did not wear the insoles, but it carried out the rehabilitation programme under the physiotherapist supervision and with his verbal feedbacks.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Bioequivalence Study of Tacrolimus 5 mg Capsule Under Fed Condition
Condition: Healthy Volunteers
MeSH terms: Malnutrition
Study type: Interventional

Summary: 
      The objective of the study is to demonstrate bioequivalence between Test Product (A):
      Tacrolimus Capsules 5 mg, manufactured by Panacea Biotec Limited, India and the corresponding
      Reference Product (B): Prograf (Tacrolimus) Capsules 5 mg, manufactured by Astellas Pharma,
      Inc., USA in 36 normal, healthy, adult, male subjects under fed condition.
    

Detailed description: 
      Total 36 normal healthy adult male subjects will be enrolled in the study. Subjects will be
      administered either the Test or the Reference Product with 240 mL of water in each period as
      per the randomization schedule. Subjects will fast for at least 10 hours prior to High Fat
      Breakfast half an hour before administration of the study drug and for four (4) additional
      hours each, post dose during each study period. Standardized meals will be provided in each
      study period. Water will not be accessible to the subjects 1 hour Predose and 2 hours Post
      dose in each period. A total of 26 blood samples will be withdrawn for pharmacokinetic
      profiling. The whole blood concentrations of Tacrolimus will be measured by a validated
      LC/MS/MS analytical method. Ratio analysis will be performed for untransformed and log
      transformed pharmacokinetic parameters Cmax, AUC0-72, AUC0 inf. ANOVA will be performed on
      log transformed pharmacokinetic parameters Cmax, AUC0-72, AUC0-inf and 90% confidence
      interval will be constructed for the ratio of geometric least square mean of the Test and
      Reference products, obtained from the log-transformed data. Bioequivalence will be concluded
      if the ratio estimate as well as its 90% confidence interval, both falls within the
      acceptable range of 80.00% to 125.00% for Cmax, AUC0-72 and AUC0-inf.
    

Intervention name(s): Tacrolimus 5 mg Capsule
Intervention type(s): Drug
Intervention description(s): Subjects will be administered either Test Product or Reference Product with 240 mL of water according to randomization schedule
Other intervention name(s): Tacrolimus Capsule
Intervention MeSH terms: Tacrolimus
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Keywords: Bioequivalence study in healthy volunteers
Evaluate Efficacy and Safety Of Tolterodine Extended Release Capsule Compared With Tolterodine Immediate Release Tablet
Condition: Urinary Incontinence
MeSH terms: Urinary Incontinence
Study type: Interventional
Phase: Phase 3

Summary: 
      To evaluate efficacy of tolterodine extended release formulation compared with immediate
      release formulation in subjects with symptoms of overactive bladder
    


Intervention name(s): tolterodine extended release capsule
Intervention type(s): Drug
Intervention MeSH terms: Tolterodine Tartrate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Infant Study of Inhaled Saline in Cystic Fibrosis
Condition: Cystic Fibrosis
MeSH terms: Cystic Fibrosis; Fibrosis
Study type: Interventional

Summary: 
      The purpose of this study is to assess whether 7% hypertonic saline (HS) is an effective and
      safe therapy in infants and young children with CF.
    

Detailed description: 
      A growing body of evidence supports the importance of intervention in Cystic Fibrosis (CF)
      lung disease during infancy and early childhood, in order to potentially delay or prevent
      irreversible lung disease. Yet, aside from antimicrobial therapies, the CF community has no
      clinical trial evidence base with which to guide pulmonary therapies in children <6 years of
      age. Hypertonic Saline (HS) is the most attractive chronic maintenance therapy to investigate
      in these young children because it addresses defective mucociliary clearance, an early step
      in the cascade of events leading to CF lung disease that is expected to be abnormal prior to
      the onset of airway infection and inflammation.

      This study is a randomized, parallel group, controlled trial to assess the efficacy and
      safety of 7% HS inhaled twice daily for 48 weeks among young children with CF 4 to < 60
      months of age at enrollment. The primary hypothesis is that, compared to isotonic saline
      (IS), HS will decrease the number of protocol-defined pulmonary exacerbations during the 48
      week treatment period. The results of the proposed trial may for the first time provide
      evidence for early initiation of HS, which, by improving mucociliary clearance, may delay or
      hinder the cycle of infection and inflammation responsible for progressive airway damage in
      CF lung disease.
    

Intervention name(s): 7% Hypertonic Saline (HS); 0.9% Isotonic Saline (IS)
Intervention type(s): Drug; Drug
Intervention description(s): Administered via inhalation twice daily for 48 ± 4 weeks. The delivery system is a PARI Sprint Junior nebulizer with a PARI Baby face mask or mouthpiece driven by a PARI Pro Neb compressor.; Administered via inhalation twice daily for 48 ± 4 weeks. The delivery system is a PARI Sprint Junior nebulizer with a PARI Baby face mask or mouthpiece driven by a PARI Pro Neb compressor.
Other intervention name(s): Hyper-Sal™, inhaled saline; Normal saline
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Cystic Fibrosis; hypertonic saline; inhaled saline
SG Healthcare and Assistive Robotics Programme (SHARP) - Proof of Concept Study
Condition: Stroke; Joint Replacement Surgery; Acquired Brain Injury; Spinal Cord Injuries; Traumatic Brain Injury With Loss of Consciousness
MeSH terms: Brain Injuries; Spinal Cord Injuries; Brain Injuries, Traumatic; Unconsciousness; Wounds and Injuries
Study type: Observational

Summary: 
      Robots are commonly used in many settings to help with transportation needs, reduce human
      injuries, and assisting clinicians during surgeries. These applications could provide direct
      benefits to patients in the clinical rehabilitation field.

      In this study, the feasibility of 2 CARE robot prototypes in facilitating dependent transfers
      and assisting patient mobility in their daily living activities will be studied.
    

Detailed description: 
      An exploratory proof of concept study involving the development and usability of 2 CARE robot
      prototypes will be validated in a hospital environment, in a broad range of patients.

      The findings from this study will then be used to further refine and develop the robot
      prototypes for future deployment in other hospitals, nursing homes and homes.
    

Intervention name(s): (1) Mobile Assistant Balance Robot; (2) Transfer Assistive Cobot
Intervention type(s): Device; Device
Intervention description(s): MRBA: Robotic wheelchair with a planar compliant robotic arm to provide balance assistance to the user at the pelvis and hip, during sit to stand, standing and walking tasks in indoor and controlled outdoor level environments.; TAC: Intelligent powered wheelchair equipped with a robotic arm that is capable of lifting payload up to 110kg, and perform a totally dependent transfer in a semi- autonomous fashion
Other intervention name(s): MRBA; TAC
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients located in hospital wards or outpatient day rehabilitation centres
      
Keywords: Assistive robots
Project RAP: Family-based HIV Prevention in the Juvenile Drug Court
Condition: HIV/AIDS
MeSH terms: Acquired Immunodeficiency Syndrome; HIV Infections
Study type: Interventional

Summary: 
      The purpose of this project is to compare the effect of a family-based HIV prevention program
      to the effect of an adolescent-only health promotion program on adolescent HIV risk and
      marijuana use among adolescents enrolled in the Juvenile Drug Court (JDC) of the Rhode Island
      Family Court.
    

Detailed description: 
      Adolescents and parents admitted to our study receive either an adolescent-only health
      education program that focuses on general health risk behaviors related to HIV/AIDS, smoking,
      diet and exercise or one that focuses on family-based HIV/AIDS education through safe
      decision-making and control of one's emotions as well as parent-child interactions that are
      associated with dysregulated affect, subsequent parenting deficits and adolescent HIV risk
      behaviors.
    

Intervention name(s): Family-Based HIV prevention; Adolescent Only Health Promotion
Intervention type(s): Behavioral; Other
Intervention description(s): This individual, family-based intervention provides sex and HIV/AIDS education as part of a family-based general health education program that focuses on safe decision-making and how to control emotions to stay safe and improve parenting skills.; An individual, adolescent-only health education program that focuses on risk behaviors related to HIV/AIDS, smoking, diet and exercise
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Adolescent; HIV; AIDS; Sexual risk; Family; Prevention; Juvenile Drug Court; Juvenile Justice; Drug Use; Marijuana
A Study on Brain Activity During Transcranial Direct Current Stimulation in Stroke Patients
Condition: Stroke
MeSH terms: Stroke
Study type: Interventional

Summary: 
      The purpose of this study is to identify the characteristics of neural plasticity seen in
      stroke patients by measuring the changes in brain activity during stimulation using
      functional near-infrared spectroscopy (fNIRS) when applying transcranial direct current
      stimulation (tDCS) for the purpose of enhancing finger function.
    


Intervention name(s): Transcranial direct current simulation
Intervention type(s): Device
Intervention description(s): Four sessions of stimulation over C3 (patient with left-sided lesion) or C4 (patient with right-sided lesion) based on 10-20 system
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Randomized, Parallel, Comparison, Double-Blind Efficacy & Safety Study of APROVEL Versus Placebo in Chinese Patients With Hypertensive Type II Diabetic Patients With Microalbuminuria
Condition: Hypertension
MeSH terms: Hypertension
Study type: Interventional
Phase: Phase 3

Summary: 
      To evaluate the effects and safety of irbesartan on proteinuria in hypertensive patients with
      type Ⅱdiabetes mellitus.
    


Intervention name(s): Irbesartan; placebo
Intervention type(s): Drug; Drug
Intervention description(s): Irbesartan capsules strength 150 mg. Irbesartan group will be initiated at one irbesartan and one placebo for 2 weeks and titrated at two capsules if well tolerated after 2 weeks , this dose will be maintained throughout the study without further dose-adjustment (2 capsules daily in the morning will be taken from randomization to study end); Placebo group: 2 placebo capsules daily as a single morning intake
Intervention MeSH terms: Irbesartan
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Animated Cartoons and Cooperation in Young Children Receiving Inhaled Medications
Condition: Patient Compliance; Inhalation Spacers
MeSH terms: Respiratory Aspiration
Study type: Interventional

Summary: 
      Up to 50% of infants and young children cry during the administration of their inhaled
      treatment for their asthma. This results in decreased lung deposition, and thus decreased
      effectiveness of their inhaled treatment.

      The objective of this study is to evaluate whether animated cartoons can increase the
      cooperation of young children with asthma who are not cooperative during the delivery of
      their ICS therapy through a pMDI/spacer.
    


Intervention name(s): Animated Cartoon; Black screen
Intervention type(s): Other; Other
Intervention description(s): An animated cartoon chosen by the parents is displayed on a smartphone attached on the spacer of the child.; A video displaying a black screen is used as control, and displayed on a smartphone attached on the spacer of the child.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
National Cancer Institute Food Study
Condition: Validation Study; Diet Surveys; Nutritional Assessment; Epidemiology; Methodologic Study
Study type: Observational

Summary: 
      Information about Americans food choices and opinions helps researchers and law makers to
      develop policies and programs to promote health. For this reason, it is important to be able
      to collect good quality information about how people think about food. This project will
      compare different ways of collecting information about food from adults.
    

Detailed description: 
      Objectives:

      -To compare different ways of collecting information about food choices and opinions from
      adults.

      Eligibility:

        -  Individuals between the ages of 20 and 70, recruited from a database of volunteers who
           wish to participate in research studies.

        -  Volunteers must have high-speed Internet access.

        -  Individuals who have previously been involved in a research study will be excluded.

      Design:

      -Participants will come to a research study center for three consecutive meals (approximately
      45 minutes per meal). On the following day, participants will return to the study center for
      an interview about their food choices and opinions (approximately 45 minutes).
    

Observational model: Other
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Healthy volunteers living in Maryland@@@
      
Keywords: Dietary Assessment Methods; Measurement of Diet; 24-Hour Diet Recall; Validation; Feeding Study
GotNet Study, The Gothenburg Nurse-led Tight Control Study
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Interventional

Summary: 
      Purpose: To compare a nurse-led clinic including person-centered care and tight control with
      "care as usual" in patients with rheumatoid arthritis (RA) and moderate/ high disease
      activity.

      Project description: Study population: Patients with RA, 18-80 yrs old, with moderate/ high
      Disease Activity Score of 28 joints (DAS28 > 3.8) and disease duration > 2 yrs in a 6-month
      randomized controlled study with a 6 month open follow-up. Intervention group (N=60):
      Nurse-led visits every 6th week, with structured person-centered care and evaluation of
      disease activity. If disease remission is not reached, pharmacological treatment including
      both short-term (intra-articular and oral steroids) and long-term alterations (DMARDs and
      biologics) is modified according to a predefined algorithm. The control group (N=60) is
      treated according to "care as usual" with visits to physician every 6th month. Outcome
      measures: Primary outcome measure is change in Diseases Activity Score (DAS). Secondary
      outcomes are quality of life, self-efficacy, disability, emotional well-being, pain, fatigue,
      sleep and satisfaction.
    


Intervention name(s): Nurse-led clinic
Intervention type(s): Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Rheumatoid arthritis; Person-centered care; Tight control
Improvement of Facial Nerve Monitoring in Parotid Surgery by Sugammadex
Condition: Injury to Nerve During Surgery
Study type: Observational

Summary: 
      To investigate the effectiveness of rapid reversal of rocuronium-induced neuromuscular block
      by sugammadex during IONM of facial nerve during parotid surgery
    

Detailed description: 
      Intraoperative neuromonitoring (IONM) of facial nerve has been applied in identifying and
      preserving facial nerve during parotid surgery. In this setting, even a single dose of
      nondepolarizing muscle relaxant may lead to delayed and weakened electromyography (EMG)
      signal in facial nerve monitoring during parotid surgery. The aim of this study was to
      investigate the effectiveness of rapid reversal of rocuronium-induced neuromuscular block by
      sugammadex during IONM of facial nerve during parotid surgery
    

Intervention name(s): sugammadex (Bridion)
Intervention type(s): Drug
Intervention description(s): single dose of sugammadex at skin incision
Observational model: Case-Only
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        adult patient with facial nerve monitoring undergoing parotid surgery
Safety and Efficacy of NNC-0156-0000-0009 in Haemophilia B Patients
Condition: Congenital Bleeding Disorder; Haemophilia B
MeSH terms: Hemostatic Disorders; Hemophilia A; Hemophilia B; Blood Coagulation Disorders; Hemorrhage
Study type: Interventional
Phase: Phase 3

Summary: 
      This trial is conducted in Africa, Asia, Europe, Japan and North America. The aim of this
      trial is to evaluate the safety and efficacy, including pharmacokinetics (the rate at which
      the body eliminates the trial drug), of NNC-0156-0000-0009 (nonacog beta pegol) when used for
      treatment and prophylaxis of bleeding episodes in patients with haemophilia B.
    


Intervention name(s): nonacog beta pegol; nonacog beta pegol; nonacog beta pegol
Intervention type(s): Drug; Drug; Drug
Intervention description(s): One single dose administered intravenously (into the vein) once weekly. Patients will receive instruction on how to treat any bleeding episode they may experience; One single dose administered intravenously (into the vein) once weekly. Patients will receive instruction on how to treat any bleeding episode they may experience; Patients will treat themselves with either a low or a high dose dependent on the severity of the bleeding episode
Other intervention name(s): NNC-0156-0000-0009; NNC-0156-0000-0009; NNC-0156-0000-0009
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Efficacy and Safety of Oral Dehydroepiandrosterone as a Concomitant Therapy to Oral Contraceptives in Women Complaining of Reduced Libido
Condition: Libido
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of the study is to evaluate the effectiveness of the study drug on the libido
      (sexual desire) of women who are taking oral contraceptives and who have experienced libido
      reductions as a side-effect of this contraceptive method The hypothesis is that there is
      superiority in the change in sexual desire and arousal component scores of the FSFI
      questionnaire from baseline to cycle 6 of the treatment with the study drug as compared to
      Placebo.
    


Intervention name(s): Dehydroepiandrosterone, BAY86-5314; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Treatment with daily oral intake of two capsules containing 50 mg DHEA each. Treatment duration will be 24 weeks; Treatment with daily oral intake of two capsules containing Placebo. Treatment duration will be 24 weeks
Intervention MeSH terms: Dehydroepiandrosterone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Loss of libido; Acquired, oral contraceptive -associated female sexual dysfunction