bioihbjkbjnl/mcl2 huggingface dataset:
A Multiple Ascending-Dose Study of RG7625 in Healthy Volunteers
Condition: Healthy Volunteer
Study type: Interventional
Phase: Phase 1

Summary: 
      This randomized, double-blind, placebo-controlled, ascending-dose, parallel-group study will
      evaluate the pharmacodynamic effects, pharmacokinetics, safety, and tolerability of one week
      of RG7625 dosing in healthy male and female volunteers. Each participant will receive a
      single dose of RG7625 or placebo followed by one week of dosing with the same treatment. Each
      participant will also receive intradermal administration of 4 recall antigens at Screening
      and on Day 7 of treatment to assess study drug effects on delayed-type hypersensitivity
      (DTH).
    


Intervention name(s): Placebo; RG7625
Intervention type(s): Drug; Drug
Intervention description(s): Participants will receive the placebo equivalent to RG7625 once or twice daily for 8 days. The first dose will be administered on Day 1 and the regimen will be continued during Days 3 to 9, with only a single dose given on Day 9.; Participants will receive RG7625 as oral capsules once or twice daily for 8 days. The first dose will be administered on Day 1 and the regimen will be continued during Days 3 to 9, with only a single dose given on Day 9.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Safety and Efficacy of AQW051 in L-dopa Induced Dyskinesias in Patients With Parkinson's Disease
Condition: Dyskinesias; Drug-induced
MeSH terms: Dyskinesias
Study type: Interventional
Phase: Phase 2

Summary: 
      This study will assess the safety, tolerability and efficacy of AQW051 in treating moderate
      to severe L-dopa induced dyskinesias (movement disorders) in patients with Parkinson's
      disease.
    


Intervention name(s): AQW051; AQW051; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Patients will receive AQW051 in a high dose once daily orally for 28 days.; Patients will receive AQW051 in a low dose once daily orally for 28 days.; Patients will receive placebo once daily orally for 28 days.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Parkinson's disease; Dyskinesia; Movement disorders; L-dopa
Topical and Oral Regimen for Skin Health
Condition: Skin Abnormalities
MeSH terms: Skin Abnormalities
Study type: Interventional

Summary: 
      The overall objective of this study is to assess how oral supplementation with Inner Calm and
      the use of topical Super Calm can affect the appearance of skin and inner wellness, such as
      redness, skin sensitivity, and reactionary skin.
    

Detailed description: 
      The landscape for skin health has expanded past a focused use of topicals to incorporate the
      use of supplementation. Notable examples include the ingestion of carotenoids and
      beta-carotene to augment skin antioxidant status or the role of diet on different skin
      conditions. The role of this investigation is to define how Inner Calm (oral supplementation)
      may promote healthier skin and how this may work in synergy with Super Calm (topical
      supplementation).
    

Intervention name(s): Tea; Serum; Moisturizer
Intervention type(s): Dietary Supplement; Other; Other
Intervention description(s): Ashwagandha(Withania somnifera) root and leaf extract (32% Withania Oligosaccharides, 10% Withanolide Glycosides, 0.5% Withaferin A) 125 mg Saffron(Crocus Sativus) stigmas extract (3.48% Crocin and 0.03% Safranal) 28mg; Aqua/Water/Eau, Glycerin, Propanediol, Diheptyl Succinate, Caprylic/Capric Triglyceride, Lactococcus Ferment Lysate, Sorbitol, Dimethicone, Steareth-21, Octyldodecyl Neopentanoate, Sodium Polyacrylate, Steareth-2, Caprylyl Glycol, Hydrogenated Polydecene, Trideceth-6, Octyldodecanol, Panthenol, Sodium PCA, Azelaic Acid, Bisabolol, Capryloyl Glycerin/Sebacic Acid Copolymer, Centella Asiatica Leaf Extract, Agastache Mexicana Flower/Leaf/Stem Extract, Caprylhydroxamic Acid, Phytic Acid, Aminomethyl Propanol, Lactic Acid, Sodium Chloride, Phenoxyethanol, Sodium Benzoate.; Aqua/Water/Eau, Glycerin, Diisopropyl Dimer Dilinoleate, Coco-Caprylate, Lactococcus Ferment Lysate, Myristyl Myristate, Dimethicone, Propanediol, Behenyl Alcohol, Glyceryl Stearate SE, Potassium Cetyl Phosphate, Palmitic Acid, Ammonium Acryloyldimethyltaurate/Beheneth-25 Methacrylate Crosspolymer, Myristyl Laurate, Caprylyl Glycol, Hydroxyethylcellulose, Myristic Acid, Tocopherol, Ethylhexylglycerin, Centella Asiatica Leaf Extract, Agastache Mexicana Flower/Leaf/Stem Extract, Helianthus Annuus (Sunflower) Seed Oil, Trisodium Ethylenediamine Disuccinate, Lactic Acid, Sodium Hydroxide, Sodium Phosphate, Disodium Phosphate, Sodium Chloride, t-Butyl Alcohol, Phenoxyethanol, Sodium Benzoate.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: skin; dermatology
Identification of the Sensory Level Block to Cold During Epidural Analgesia for Labor: A Cohort Study to Determine the Influence of the Direction of Testing
Condition: Labor Pain
MeSH terms: Labor Pain
Study type: Interventional

Summary: 
      Assessment of the upper sensory block level during neuraxial analgesia for labor and delivery
      is an essential component of clinical management and patient safety. A variety of methods
      have been used for testing the sensory block such as cold, light touch, sharp touch or prick
      and transcutaneous electrical stimulation. In addition to the diversity of methods, the
      endpoints used by investigators have also been variable, considering total or partial
      responses as endpoints. Not surprisingly, a variable sensory block level could be identified
      as a result of the different methods and types of question asked by the examiner. Another
      complicating factor is the lack of standardization of the direction of the testing as it
      relates to anesthetized and non-anesthetized areas. This lack of standardization may result
      in a difference of several dermatomes in the level that two different assessors might record
      for the same patient. Considering a clinical research scenario, it may be difficult to
      replicate results and implement clinical practices. The objective of this study is to
      determine the degree of agreement between two methods of assessing the sensory block level to
      cold in women receiving epidural analgesia for labor (anesthetized to non-anesthetized
      segments versus non-anesthetized to anesthetized segments).
    


Intervention name(s): Sensory block level check using ice
Intervention type(s): Diagnostic Test
Intervention description(s): Patients are asked to report when the ice feels as cold as it does on the forehead.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: epidural; sensory block level; dermatome
GSK573719 Dose Ranging Study in Chronic Obstructive Pulmonary Disease
Condition: Pulmonary Disease, Chronic Obstructive
MeSH terms: Lung Diseases; Pulmonary Disease, Chronic Obstructive
Study type: Interventional
Phase: Phase 2

Summary: 
      The study will evaluate the dose response, safety, and pharmacokinetics of GSK573719 compared
      with placebo in subjects with COPD.
    

Detailed description: 
      This is multicenter, randomized, double-blind, double-dummy, placebo-controlled, three-way
      cross-over, incomplete block design study to evaluation of 5 doses of GSK573719 administered
      once-daily and 3 doses of GSK573719 administered twice-daily over 14 days in subjects with
      COPD and will include tiotropium as an open-label active control. The pharmacokinetic profile
      of GSK573719 will also be evaluated.
    

Intervention name(s): Tiotropium; Placebo; GSK573179
Intervention type(s): Drug; Drug; Drug
Intervention description(s): long-acting muscarinic receptor antagonist; 18mcg once-daily; Inactive/ excipients only; GSK573179 investigational drug
Intervention MeSH terms: Tiotropium Bromide
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Dose ranging; Chronic Bronchitis; Long-acting muscarinic antagonist; cross-over; COPD; Emphysema; Chronic Obstructive Pulmonary Disease (COPD); anticholinergic
Efficacy Assessment of SCENAR Device on Common Spinal Pain Syndrome
Condition: Pain Syndrome
MeSH terms: Syndrome; Somatoform Disorders
Study type: Interventional

Summary: 
      Randomized, singled blinded, controlled trial of the efficacy of a SCENAR session in patients
      with vertebral pain. SCENAR is an electrotherapy device.
    


Intervention name(s): SCENAR application; SCENAR application with the device off
Intervention type(s): Device; Device
Intervention description(s): Active SCENAR application on the painful area; Placebo SCENAR application on the painful area
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Spinal pain
Community Based Intervention and Evaluation of the Impact of Social Marketing of a Diarrhea Management Pack
Condition: Diarrhea
MeSH terms: Diarrhea
Study type: Interventional
Phase: Phase 4

Summary: 
      Diarrhoeal diseases are still the major paediatric health concern worldwide, contributing for
      2.5 million annual deaths in children. Although the treatment of diarrhoeal illness as per
      the World Health Organization (WHO) guidelines brings about a considerable decline in the
      burden of the disease but there is still a lot to be done for this issue. Zinc
      supplementation along with Oral Rehydration Solution (ORS) has emerged as a potent approach
      to treat diarrhoea. It is believed that the children having zinc deficiency are at high risk
      of developing infectious diseases which eventually lead to a high burden of mortality.

      In order to prevent and effectively manage diarrheal episodes, it is important that water
      purification tablets, zinc and oral rehydration salt is always available in each household.
      Though, these products are easily available in the market separately, but are rarely
      available together in any household. If these products are made available in a single packet,
      it is likely to be an effective strategy in combating diarrheal diseases in the community.
    


Intervention name(s): Diarrhea Pack; ORS
Intervention type(s): Other; Other
Intervention description(s): Low osmolality ORS, Zinc tablets, water purification tablets and pictorial chart; ORS has been supplied to diarrheal cases as standard care through the LHW program at community level
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Children; Recovery; Diarrhea Pack; Social Marketing
Study Comparing Remission Rates, in Patients With Major Depressive Disorder (MDD)
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Study type: Observational

Summary: 
      Tools known as 'depression scales 'are widely used as assessments to evaluate a patient's
      response to treatment. The purpose of this study is the evaluation of the remission rates for
      patients with MDD. The evaluation will involve the use of HAM-D 17, and HAM-D 7
      questionnaires and the comparison of those questionnaires.
    

Detailed description: 
      12 weeks random
    

Intervention name(s): Cohort
Intervention type(s): Other
Intervention description(s): Cohort (Patients diagnosed with MDD who are either changing treatment or have never received treatment).
Observational model: Cohort
Sampling method: Probability Sample
Study population: 
        Patients diagnosed with MDD who are either changing treatment or have never received
        treatment.
Monitoring and Evaluation of Micronutrients (Sprinkles) Project
Condition: Anemia
Study type: Interventional

Summary: 
      The purpose of this study is 1) to evaluate the effectiveness in reducing anemia among
      children 6-24 months of age by providing daily micronutrient Sprinkles through the Government
      of Pakistan's Lady Health Worker program; 2) to assist in the monitoring the National
      Sprinkles Pilot Project.
    

Detailed description: 
      According to the recent National Nutrition Survey in Pakistan (2001-2002), approximately
      66.5% of children under five have anaemia.

      Looking at the magnitude of the problem, National Program for Family Planning (FP) and
      Primary Health Care (PHC) (also known as the Lady Health Workers (LHW) Program) has developed
      National Sprinkles Pilot Project Proposal with technical assistance of Micronutrient
      Initiative and Aga Khan University (AKU). As the projects technical partner, AKU is
      responsible to conduct the monitoring and evaluation of the project.

      The study will use a cluster randomized pre-post intervention design that compares before and
      after hemoglobin (Hb) measurements, serum ferritin, serum retinol and urinary iodine among
      children who received Sprinkles and age-appropriate feeding advice (Sprinkles-Advice group)
      and children who only receive age-appropriate feeding advice (Advice-only group).
      Age-appropriate feeding advice is part of the standard nutrition messages given by all Lady
      Health Workers (LHWs) during their community visits. However, intervention LHWs, will give
      additional advice regarding the benefits of Sprinkles and its appropriate use.

      The target population selected for the study consisted of children between the ages of six
      and eighteen months of age in the catchment area of the Lady Health Workers.
    

Intervention name(s): SPRINKLES; Nutrition education
Intervention type(s): Dietary Supplement; Behavioral
Intervention description(s): Sprinkles is a multiple micronutrient fortificant. It is packed as a single serving sachets each containing micro encapsulated iron (12.5 mg), zinc (7.5 mg), vitamin C (30 mg), vitamin A (300 µg), vitamin D (5 µg), folic acid (150 µg) and iodine (90µg).
Two month supply of the Sprinkle sachet along with advice on its benefits as well as its appropriate use will be given by the LHWs. The LHWs will also provide their age-appropriate nutritional advice as per their regular door to door community services.; Nutrition education will be provided by LHWs as per their regular routine monthly door to door community services
Other intervention name(s): Multiple micronutrient fortificant
Intervention MeSH terms: Micronutrients
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: micronutrients
Knee Alignment Contributions to Anterior Cruciate Ligament (ACL) Injury
Condition: Knee Injuries
MeSH terms: Wounds and Injuries; Knee Injuries
Study type: Observational

Summary: 
      This study evaluates the the anatomic factors of the knee that may predispose to ACL injury.
    

Detailed description: 
      Despite intense study of anterior cruciate ligament injury during the past three decades, the
      mechanisms of this injury have not been clearly defined. A recent study by the Principle
      Investigator identified differences in leg alignment when a single leg landing during a
      sports activity resulted in a torn ACL and when it did not (provocative versus control
      alignment, respectively).

      The purpose of the study is to quantify the tibiofemoral alignment in the lateral compartment
      of the knee in the provocative landing position and the control landing position. in order to
      elucidate possible mechanisms of ACL injury Material and Methods: 25 normal controls will be
      recruited from the greater Washington DC population. Magnetic resonance images in the
      sagittal plane will be acquired for a single leg of each subject. These images will cover the
      lateral compartment of the knee and will be acquired with the leg in three positions, one
      that emulates the injury position, one that exagerrates the injury position, and one that
      emulates the control landing position. Statistical analysis of the measurements between the
      provocative, exagerrated provocative, and control positions will then be performed.

      These insights could then be applied to improving training focused on reducing the incidences
      of ACL rupture; improving bracing designs to help athletes most at risk of ACL rupture or
      those recovering from ACL injury/surgery; and improving ACL replacement surgeries.
    

Observational model: Case-Only
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        healthy volunteer athletes and excluded those who had any of the following criteria: 1)
        counter-indications to magnetic resonance imaging (e.g., pregnancy or postsurgical hardware
        [plates, screws, aneurysm clip, implanted cardiac pacemaker, etc.]); (2) relevant medical
        problems (e.g., connective tissue problems, paralyzed hemidiaphragm, morbid obesity,
        claustrophobia, etc.); (3) clinical signs of an impairment or abnormality in the knee
        (e.g., abnormal range of motion, muscle weakness, or malalignment); (4) injury to the knee
        that required medical attention; (5) previous surgery on the knee; or (6) current pain in
        the knee.
      
Keywords: anterior cruciate ligament; Knee Joint
Nicotine Patch as an Analgesic Adjuvant After Surgery
Condition: Pain
Study type: Interventional
Phase: Phase 4

Summary: 
      Effect of nicotine patch as an adjutant for acute pain after surgery.
    

Detailed description: 
      This is a dose finding trial for nicotine patches as analgesics. Doses used are 5mg/ 10mg/
      15mg or placebo. Primary outcome variable is reported pain score (VAS), secondary is morphine
      PCA utilization, nausea, sedation, and hemodynamic changes.
    

Intervention name(s): nicotine patch; nicotine patch; placebo; placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): nicotine patch (0,5,10 or 15mg/day) applied to smokers; nicotine patch (0,5,10,or 15mg/day) applied to nonsmokers; placebo patch applied to smokers; placebo patch applied to nonsmokers
Other intervention name(s): nicotrol; nicotrol
Intervention MeSH terms: Nicotine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: acute pain; nicotine; nausea; sedation
Glycemic Index and CVD: a Crossover Feeding Study
Condition: Obesity
MeSH terms: Obesity
Study type: Interventional

Summary: 
      This study will compare the physiological effects of two isoenergetic, nutrient-controlled
      diets that differ in glycemic index. The diets will be studied in obese adults in a 10-day
      crossover feeding trial.
    

Detailed description: 
      This study will compare the physiological effects of two isoenergetic, nutrient-controlled
      diets that differ in glycemic index. The diets will be studied in obese male adults in a
      10-day crossover feeding trial. Hypothesis: Obese subjects will show improvements in clinical
      endpoints associated with risk for diabetes and cardiovascular disease (CVD) after consuming
      a controlled low (compared to high) glycemic index diet for 10 days. 1º endpoint: insulin
      sensitivity as measured by the modified Frequently Sampled Intravenous Glucose Tolerance Test
      (FSIVGTT). 2º endpoints: CVD risk factors; postprandial studies of oxidative stress; thermic
      effect of food.
    

Intervention name(s): low vs high glycemic index diet
Intervention type(s): Behavioral
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single
Primary purpose: Prevention
Keywords: obesity; glycemic index; insulin resistance; cardiovascular disease; diabetes
Study for the Evaluation of the Efficacy and Safety of the Dermal Filler Princess® VOLUME in Nasolabial Folds
Condition: Nasolabial Folds
Study type: Interventional

Summary: 
      The aim of this clinical trial is to evaluate the efficacy and safety of Princess® VOLUME for
      the correction of nasolabial folds.
    


Intervention name(s): Princess® VOLUME
Intervention type(s): Device
Other intervention name(s): highly cross-linked, viscoelastic hyaluronic acid injectable gel implant
Intervention MeSH terms: Hyaluronic Acid
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Opioid Free Pterygopalatine Ganglion Block Based Multimodal Anesthesia for Tonsillectomy Operations
Condition: PREVENTION OF POSTTONSILLECTOMY PAIN; DECREASE POSTTONSILLECTOMY NAUSEA AND VOMITTING; DECREASE POSTOPERATIVE HOSPITAL STAY
MeSH terms: Ganglion Cysts; Nausea
Study type: Interventional

Summary: 
      intraoperative opioid administration versus intraoperative pterygopalatine ganglion block
      based opioid free anesthesia to compare outcomes such as postoperative administration of
      opioid rates of nausea and vomiting, Post Anesthesia Care Unit (PACU) length of stay
    

Detailed description: 
      Group A ;( opioid based multimodal anesthesia) One hundred and twenty pediatric patients will
      do elective tonsillectomy or adenotonsillectomy surgery using opioid based multimodal
      anesthesia.

      Group B ;( opioid free pterygopalatine ganglion block based multimodal anesthesia) One
      hundred and twenty pediatric patients will do elective tonsillectomy or adenotonsillectomy
      surgery using opioid free pterygopalatine ganglion block based multimodal anesthesia.

      For each patient, intraoperative hemodynamics, additional intraoperative analgesia required,
      the length of PACU stay, administration of postoperative opioids, administration of
      postoperative non-opioid analgesics, postoperative (visual analogue score) VAS score, will be
      recorded.
    

Intervention name(s): opioid based multimodal anesthesia; pterygopalatine ganglion block based multimodal anesthesia)
Intervention type(s): Procedure; Procedure
Intervention description(s): elective tonsillectomy or adenotonsillectomy surgery using opioid based multimodal anesthesia.; elective tonsillectomy or adenotonsillectomy surgery using opioid free pterygopalatine ganglion block based multimodal anesthesia.
Intervention MeSH terms: Anesthetics
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Pharmacokinetic Characterization of Intramuscular Olanzapine Depot
Condition: Schizophrenia; Schizoaffective Disorder
MeSH terms: Schizophrenia; Psychotic Disorders
Study type: Interventional
Phase: Phase 1

Summary: 
      The goals of this study are to:

      Determine the blood levels of intramuscular (IM) olanzapine depot in patients at different
      points in time after an injection, and compare these levels to the amount of olanzapine in
      the blood of patients after treated by oral administration with Zyprexa (olanzapine) tablets
      or by intramuscular administration with Zyprexa IntraMuscular (olanzapine for injection).
    


Intervention name(s): Intramuscular Olanzapine Depot
Intervention type(s): Drug
Intervention MeSH terms: Olanzapine
Primary purpose: Treatment