bioihbjkbjnl/mcl2 huggingface dataset:
Blue Light for Treating Psoriasis Vulgaris
Condition: Psoriasis Vulgaris
MeSH terms: Psoriasis
Study type: Interventional

Summary: 
      The purpose of this study is to determine the efficacy and safety of a blue light device for
      treating Psoriasis vulgaris. The study will compare a blue light treated plaque with an
      untreated control plaque. Additionally, two intensities of blue light are compared.
    

Detailed description: 
      Blue light has been shown to release bioactive nitric oxide (NO) from nitrite and nitrosated
      proteins found in high concentrations in the skin. This bioactive NO has many physiological
      functions regulating immune responses, proliferation / differentiation as well as local blood
      Perfusion of the skin. The study will test the PSO-CT02 device, an new investigational
      medical device emitting blue light with a peak wavelength of 453nm on treating localised mild
      Psoriasis vulgaris. It can be worn on the Skin above the effected skin area. In this study
      Treatment (target) and control area as well as intensity of blue light are randomized. The
      control area will serve as reference. 50 Patients will treat the target area daily (at least
      5 times/week) at home for an initial treatment period of 4 weeks. During those 4 weeks,
      patients will return to the study site for safety and effectiveness assessments twice. After
      this initiation period patients will treat their plaque for further 8 weeks (3 times/week).
      This is followed by a 4 week follow up phase without treatment.
    

Intervention name(s): PSO-CT02
Intervention type(s): Device
Intervention description(s): The PSO-CT02 device is a non CE marked investigational medical device that is worn on the affected skin area where it irradiates the Psoriasis plaque for 30 minutes with blue light.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
To Evaluate Patient Preference of Movantik and Polyethylene Glycol 3350 for Opioid Induced Constipation
Condition: Opioid Induced Constipation
MeSH terms: Constipation; Opioid-Induced Constipation
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to determine whether patients with opioid induced constipation
      prefer treatment with naloxegol (Movantik) or with Polyethylene Glycol 3350.
    

Detailed description: 
      This study is a prospective, randomized, open-label crossover study consisting of a 1-week
      washout period, a 2-week treatment period, another 1-week washout and a final 2-week
      treatment period. The study will assess the overall patient preference Movantik versus
      Polyethylene Glycol 3350 for the treatment of their opioid-induced constipation. This study
      will also evaluate the reasons for patient preference (only among subjects who indicate a
      preference), patient global impression of change, and change in bowel function over the
      treatment periods measured by Bowel Function Index. Patient's bowel movement diary will also
      be collected during the study.
    

Intervention name(s): Polyethylene Glycol 3350; Movantik
Intervention type(s): Drug; Drug
Intervention description(s): Polyethylene Glycol 3350, 17 grams of powder to be dissolved in 4 to 8 ounces of water, juice, soda, coffee or tea to be taken once a day.
Bisacodyl 5mg, 1-3 tablets may be taken by subject who does not experience a bowel movement within 72 hours.; Movantik 25 mg, 1 tablet taken once a day on an empty stomach at least 1 hour prior to the first meal of the day or 2 hours after the meal.
Bisacodyl 5mg, 1-3 tablets may be taken by subject who does not experience a bowel movement within 72 hours.
Other intervention name(s): MiraLAX; Naloxegol
Intervention MeSH terms: Naloxegol; Polyethylene glycol 3350
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Opioid Induced constipation,; constipation,; laxative,; bowel movement,; Movantik,; Naloxegol
Efficacy and Safety of Plasma Exchange With Albutein® 5% in Participants With Amyotrophic Lateral Sclerosis
Condition: Amyotrophic Lateral Sclerosis
MeSH terms: Motor Neuron Disease; Amyotrophic Lateral Sclerosis; Sclerosis
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a pilot, phase 2, prospective, open-label, single-arm study to evaluate disease
      progression, forced vital capacity, and the safety and tolerability of plasma exchange (PE)
      using Albutein® 5% in participants with amyotrophic lateral sclerosis (ALS).
    

Detailed description: 
      This is a phase 2, prospective, open-label, single-arm pilot study to evaluate the efficacy
      and safety of PE with Albutein® 5% in participants with ALS. The planned enrollment is 10
      participants who have a definite, possible, or probable diagnosis of ALS, according to the
      revised El Escorial criteria. Enrolled participants will be treated with PE using Albutein 5%
      as a replacement solution during an Intensive Treatment Phase (2 PEs per week over 3 weeks)
      followed by a Maintenance Treatment Phase (weekly PE for 21 weeks) for a total treatment
      duration of 6 months. A 6-month follow up will begin after the last PE.
    

Intervention name(s): Albutein 5%; Plasma Exchange
Intervention type(s): Biological; Procedure
Intervention description(s): Albutein is manufactured from human plasma. The dose of Albutein 5% for replacement following plasma removal will be calculated based on gender, weight, and the hematocrit of the participant.; Plasma Exchange will be performed using albutein 5% as the replacement solution.
Other intervention name(s): Albutein 5% solution for perfusion
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Effect of Deep Brain Stimulation on Gait of Patients With Parkinson's Disease Depending on Electrode Location in Subthalamic Area
Condition: Parkinson's Disease
MeSH terms: Parkinson Disease
Study type: Interventional
Phase: Phase 4

Summary: 
      Deep brain stimulation of STN (subthalamic nucleus) at high frequencies generally improved
      gait in parkinsonian patients. However, sometimes the investigators observed a gait
      aggravation either with using high voltage and high frequencies, either because of suboptimal
      placement of electrode inside Forel H2 field. The most frequent hypothesise to explain this
      gait aggravation is a modulation of the activity of pedunculopontine nucleus due to a
      diffusion of the electric stimulation current to the fibbers going near STN area.

      The primary purpose of this study is to compare the effect of deep brain stimulation with
      high frequency versus low frequency on gait of patients whatever the electrodes placement
      (STN ou Forel fields) and whatever the medication condition (with or without treatment).
    

Detailed description: 
      A randomized, double-blind, parallel-group study 2 groups of patients: 10 patients with
      electrodes placed in STN and 10 patients with electrodes placed in Forel fields.

      1 group of healthy paired-control (n=20).

      Patients will be evaluated without and with treatment on two mornings (J0 and J0+1day).

      In each condition of treatment, 3 conditions of stimulation were tested: without stimulation;
      frequency 25Hz, frequency 130 Hz.

      Evaluations consist on :

        -  motor evaluation (UPDRS)

        -  gait evaluation (to walk on a gait mat)

        -  Stand-Walk-Sit Test
    

Intervention name(s): deep brain stimulation
Intervention type(s): Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Parkinson's disease; Deep brain stimulation; Gait; Freezing; Electrode placements
Pelvic Floor Consciousness in Women With Pelvic Floor Dysfunction
Condition: Pelvic Floor Disorders
MeSH terms: Pelvic Floor Disorders
Study type: Interventional

Summary: 
      The purpose of the study is to compare the efficacy of different modalities of motor learning
      of pelvic floor muscle contraction in women with pelvic floor dysfunctions, considering the
      efficacy of the treatment as improving the specific quality of life related to pelvic floor
      dysfunctions and improvement of the muscular properties of the pelvic floor muscles.
    


Intervention name(s): Active exercises of the pelvic floor muscles & Electrostimulation & Biofeedback; Active exercises of the pelvic floor muscles & Biofeedback; Active exercises of the pelvic floor muscles & Transabdominal US Biofeedback; Active exercises of the pelvic floor muscles & Electrostimulation &Transabdominal US Biofeedback
Intervention type(s): Other; Other; Other; Other
Intervention description(s): See information included in arm/group descriptions.; See information included in arm/group descriptions.; See information included in arm/group descriptions.; See information included in arm/group descriptions.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Motor Learning; Pelvic Floor Muscles; Physiotherapy; Biofeedback; Consciousness
A mHealth Application as a Screening Tool for Neonatal Jaundice in Filipino Neonates
Condition: Jaundice, Neonatal
MeSH terms: Jaundice, Neonatal; Jaundice
Study type: Interventional

Summary: 
      The purpose of the study is to test the reliability of the Picterus smartphone application in
      Filipino neonates. A descriptive cross-sectional study will be the method to understand the
      correlation of the modalities and to determine the reliability of the application
    

Detailed description: 
      The purpose of the study is to test the reliability of the Picterus smartphone application.

      The study is designed for Filipino neonates, but implemented in other LMIC. The participants
      include newborns with or without jaundice, Gestational age >37 weeks, Age0-14days, Weight
      >2500 gram and absence of congenital malformations. Demographic data of the neonates will be
      collected together with all the performed tests and it will be stored in a secured system.
      Blood will be drawn and measure the bilirubin level of the neonates in a standard clinical
      routine and will be compared to the estimated bilirubin performed with the Picterus
      smartphone application.

      A descriptive cross-sectional study will be the method to understand the correlation of the
      modalities and to determine the reliability of the application.

      It will provide an answer to whether the Picterus smartphone application is reliable to other
      populations, especially to darker skin and with high melanin content such as Filipino
      neonates.
    

Intervention name(s): Picterus Jaundice Pro
Intervention type(s): Device
Intervention description(s): Use Picterus Jaundice Pro, a smartphone app that is used to take photo of the newborns skin, where the Picterus calibration card is place.
Other intervention name(s): Picterus JP
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Screening
Operative Difficulty Grading Scale for Laparoscopic Cholecystectomy in BPKIHS
Condition: Laparoscopic Cholecystectomy
Study type: Observational

Summary: 
      The main purpose of this study is to utilize operative grading scale to predict conversion to
      open,complication and reintervention and validate Nassar Scale.
    

Detailed description: 
      Laparoscopic cholecystectomy is the commonly performed procedure in our institute.
      Laparosopic cholecystectomy is high variable surgery ranging from simple routine operation to
      difficult surgery leading to increased morbidity and mortality. The majority of previous
      scores use a combination of pre-operative and operative data and were produced in studies
      that were limited by retrospective data, small sample sizes and lack of external validation.

      Very few intraoperative difficulty grading scale was published and none are widely used in
      clinical practice. So operative grading scale will have advantages of assisting in
      intra-operative strategy and planning, allowing comparison across different research studies,
      facilitating risk adjustment for surgical outcomes and providing an aid in training surgeons
      and monitoring of training progression.

      The main purpose of this study is to utilize operative grading scale to predict conversion to
      open,complication and reintervention.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Hospital patients
      
Keywords: Surgery; Laparoscopic; Cholecystectomy; Cholecystitis
Clinical Effect of dTMS in Major Depressive Disorder
Condition: MAjor Depressive Disorder
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Study type: Interventional

Summary: 
      Aim: To test if there is a relation between deep Transcranial Magnetic Stimulation (dTMS)
      dose and clinical effect on Major Depressive Disorder (MDD) Method: 30 patients with moderate
      to severe MDD without concurrent medication will be randomised to three different treatment
      protocols of dTMS. Symptom severity of MDD will be quantified before, during and after dTMS.
    

Detailed description: 
      population: inclusion criteria:

        1. Ongoing episode of MDD (ICD10 F32.x) according to MINI/SCID1.

        2. Montgomery Asberg Depression Rating Scale (MADRS) score 20-60

        3. TMS safe exclusion criteria:

      1. Bipolar disorder 2. Substance abuse 3. fluoxetine treatment last three weeks 4. Other
      major Central Nervous System (CNS) disorder 5. Acute medical disorders 6. previous TMS or
      Electro Convulsive Treatment (ECT) <2 months before inclusion

      ratings: MADRS at inclusion, baseline, weekly, at last visit Clinical Global Impression
      Severity (CGI-S) score at baseline, at last visit Global Self-Evaluation-Memory (GSE-My) at
      last visit Alcohol Use Disorder Identification Test (AUDIT-C) at inclusion EuroQual 5
      Dimension (EQ5D) at baseline, at last visit Quick Inventory of Depressive Symptomatology Self
      Rating (QIDS-SR) baseline, weekly, last visit

      condition: Each subject is randomised to condition A, B or C of dTMS (Brainsway): half the
      standard protocol (10 min; A), standard protocol (20 min; B) or double standard protocol (40
      min, C). 20 treatment sessions/subject. 10 subjects in each group.

      Primary endpoint: MADRS at baseline - MADRS at last visit (Intention TO Treat (ITT), Last
      Observation Carried Forward (LOCF))
    

Intervention name(s): dTMS
Intervention type(s): Device
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Transcranial Magnetic Stimulation
Galectin-3 Blockade in Patients With High Blood Pressure
Condition: Hypertension
MeSH terms: Hypertension
Study type: Interventional

Summary: 
      This study will investigate if Modified Citrus Pectin (MCP) can help people with high blood
      pressure. MCP is a dietary supplement that is derived from plants, and therefore is not
      subject to approval by the U.S. Food and Drug Administration (FDA). However, MCP has been
      deemed as 'generally regarded as safe' by the FDA.

      This study will examine whether Modified Citrus Pectin (MCP) can help people with high blood
      pressure. The study will help understand how MCP may affect the risk for heart disease in
      patients with high blood pressure.
    

Detailed description: 
      Gal-3 appears to be a potential mediator of cardiac fibrosis, preceding the development of
      clinical heart failure. In this study, we seek to identify individuals at risk for the
      development of heart failure based on clinical hypertension and elevated Gal-3
      concentrations. Participants will be randomized to receive a Gal-3 inhibitor (MCP) or
      placebo. The primary outcome will be the effect on collagen metabolism, and secondary
      outcomes include echocardiographic measures of cardiac structure and function, and
      non-invasive measures of vascular function.
    

Intervention name(s): Modified Citrus Pectin (MCP) vs placebo
Intervention type(s): Dietary Supplement
Intervention description(s): 5 grams by mouth three times a day
Other intervention name(s): MCP; PectaSol-C
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Hypertension; Galectin 3; Fibrosis; Vascular Stiffness; Echocardiography
Impact of Buspirone Maintenance on the Reinforcing Effects of Cocaine
Condition: Cocaine Use Disorders
Study type: Interventional

Summary: 
      Cocaine use disorders are an unrelenting public health concern. Intensive research efforts
      have yielded behavioral interventions that reduce cocaine use, however, these interventions
      are not universally effective and treatment effects diminish over time. Development of a
      pharmacotherapy that enhances the efficacy of these interventions is a priority for the
      National Institute on Drug Abuse. This study proposes to determine the impact of buspirone
      maintenance on self-administration of cocaine and alternative reinforcers. These preliminary
      data will be used to support further research developing buspirone as a pharmacotherapy for
      cocaine use disorders. We hypothesize that buspirone will attenuate the reinforcing effects
      of cocaine and increase the reinforcing effects of alternative reinforcers.
    


Intervention name(s): Buspirone; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Subjects will be maintained on oral buspirone (10 mg administered 3 times daily) for 6 days each during the study in random order.; Subjects will be maintained on oral placebo (0 mg administered 3 times daily) for 6 days each during the study in random order.
Intervention MeSH terms: Buspirone
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Basic Science
The Dose-Response Effects of Lean Beef in a Mediterranean-Style Dietary Pattern on Cardiovascular Disease Risk Factors
Condition: Healthy Volunteers
Study type: Interventional

Summary: 
      The objective of this study is to evaluate the effects of different quantities of lean beef
      (0.5, 2.5, 5.5 oz/day) on lipids, lipoproteins, and vascular health endpoints in the context
      of a modified Mediterranean dietary pattern that is representative of foods typically
      consumed in the United States.
    

Detailed description: 
      The DASH (Dietary Approaches to Stop Hypertension) dietary pattern, the USDA Food Pattern,
      and the American Heart Association (AHA) Diet are all recommended for the reduction of LDL-C
      and blood pressure, two major risk factors for cardiovascular disease (CVD). The recommended
      food-based dietary patterns emphasize consumption of vegetables, fruits and whole grains;
      include low-fat dairy products, poultry, fish, legumes, non-tropical vegetable oils and nuts;
      and limit intake of sweets, sugar-sweetened beverages and red meats. The Mediterranean
      dietary pattern has gained widespread popularity because of an impressive evidence base
      showing health benefits in the prevention of many chronic diseases including CVD. The
      Mediterranean Diet Pyramid recommends that red meat be consumed less than 2 servings per
      week, with an emphasis on lean cuts. However, as the BOLD (Beef in an Optimal Lean Diet)
      study has demonstrated, lean beef can be included in a heart healthy dietary pattern that
      achieves both low density lipoprotein and blood pressure-lowering effects. The BOLD study
      utilized beef consumption levels of 4 or 5.4 ounces of lean beef daily, which is
      significantly higher than the American average of app. 3 ounces per day. This study will
      evaluate three levels of beef in the context of a Mediterranean diet, compared to an Average
      American diet.
    

Intervention name(s): MED 0.5; MED 2.5; MED 5.5; AAD 2.5
Intervention type(s): Other; Other; Other; Other
Intervention description(s): Participants will be fed a Mediterranean diet providing 0.5 oz. per day of lean beef.; Participants will be fed a Mediterranean diet providing 2.5 oz. per day of lean beef.; Participants will be fed a Mediterranean diet providing 5.5 oz. per day of lean beef.; Participants will be fed an average American diet providing 2.5 oz. per day of lean beef.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Prevention
Observational Study on a Chinese Population
Condition: Metabolic Disease; Nutrition Disorders; Genetic Predisposition to Disease
MeSH terms: Metabolic Diseases; Nutrition Disorders; Genetic Predisposition to Disease
Study type: Observational

Summary: 
      An observational study was conducted in a health examination center to distinguish risk
      factors for health in a randomly recruited volunteers of Chinese population.
    


Intervention name(s): No intervention.
Intervention type(s): Other
Intervention description(s): Cross-sectional observation without interventions.
Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        Both males and females were included.
      
Biospecimen description: 
      Blood.
A Single-dose Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of BMS-986263 in Participants With Varying Degrees of Liver Impairment
Condition: Hepatic Impairment
MeSH terms: Liver Diseases
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary purpose of this study is to evaluate the effect of liver impairment on the safety
      and pharmacokinetics (PK) of BMS-986263
    


Intervention name(s): BMS-986263
Intervention type(s): Drug
Intervention description(s): Single Dose
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Safety & Immunogenicity of Immunisations With EN41-UGR7C HIV Vaccine
Condition: - HIV
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of the clinical trial is to evaluate the safety and immunogenicity in female
      volunteers of EN41-UGR7C vaccine candidate adjuvanted with Alum using IM administration. The
      objective of the immunisation is to induce mucosal and systemic binding and neutralizing
      antibodies against HIV in order to block the virus on the mucosal surface and neutralise the
      viral particles that may eventually succeed in crossing the mucosal barrier.

      This is a Phase 1 exploratory study. EN41-UGR7C will be administered for the first time in
      humans.

      Volunteers who are vaccinated with EN41-UGR7C may develop an immune response against HIV, but
      its ability to induce meaningful protection against HIV will not be known before Phase 3
      efficacy trials are completed, as correlates of protection against HIV are not yet clearly
      defined.

      Consequently, there is no direct benefit to volunteers. They will be reimbursed for their
      time and travel.
    


Intervention name(s): EN41-UGR7C HIV vaccine; NaCl
Intervention type(s): Biological; Biological
Other intervention name(s): EN41-UGR7C adjuvanted with Alum; NaCl placebo vaccine
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Safety of this HIV vaccine