bioihbjkbjnl/mcl2 huggingface dataset:
A Randomized Study in Children Ages Birth Through Three Years Undergoing Unilateral Cataract Extraction With or Without Lens Replacement
Condition: Unilateral Cataract Extraction; Congenital Cataract
MeSH terms: Cataract
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate the effect of OMS302 compared to phenylephrine when
      administered in irrigation solution during cataract extraction on intraoperative pupil
      diameter, acute postoperative pain, and safety in children birth through 3 years.
    

Detailed description: 
      This study is a randomized, parallel-group, double-masked, phenylephrine-controlled study of
      OMS302 in young children ages birth through three years undergoing unilateral cataract
      extraction with or without lens replacement. Administration of test irrigation solutions will
      take place in a double-masked fashion.

      Intraoperative pupil size will be determined by measurement of pupil diameter from still
      photos captured from video recordings of the procedure. Pupil diameter measurements will be
      performed immediately prior to the initial incision and at one-minute intervals until the end
      of the procedure (wound closure). Pain will be assessed by the Alder Hey Triage Pain Score.
    

Intervention name(s): OMS302; Phenylephrine HCl
Intervention type(s): Drug; Drug
Intervention MeSH terms: Phenylephrine; Oxymetazoline
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Cataract; Lens replacement; pediatric
Comparison Between Connective Graft and Xenogeneic Matrix, in Patients With Multiple Gingival Recessions
Condition: Gingival Recession, Generalized
MeSH terms: Gingival Recession
Study type: Interventional

Summary: 
      Subepithelial connective tissue graft (SCTG) is considered the gold standard for root
      coverage treatment. However, it is associated with postoperative morbidity, limited amount of
      donor tissue, and longer surgical time. Thus, the search for a tissue substitute for SCTG is
      increasing. Currently, one of the possible autogenous soft tissue substitutes found in the
      market is the Mucograft® xenogeneic matrix (CM). The results with the use of MC are very
      promising, both for root coverage as well as for the gain of keratinized tissue. The present
      study consists of a parallel randomized clinical trial to compare SCTG (control group) and CM
      (test group) in the treatment of Miller's class I and II gingival recessions, multiple in
      aesthetic areas (upper central incisors, Lateral and canine).
    

Detailed description: 
      Obtaining an aesthetic smile is one of the main reasons for the patient's demand for dental
      treatment, especially when it comes to gingival recession. However, there is a lack of
      evidence in the literature explaining the most appropriate type of treatment for multiple
      recessions in aesthetic areas. For unitary gingival recessions, the subepithelial connective
      tissue graft (SCTG) is considered the gold standard because it presents greater
      predictability for root coverage. However, it is associated with postoperative morbidity,
      limited amount of donor tissue, and longer surgical time. Thus, the search for a tissue
      substitute for SCTG is increasing. Currently, one of the possible autogenous soft tissue
      substitutes found in the market is the Mucograft® xenogeneic matrix (CM). The results with
      the use of CM are very promising, both for root coverage as well as for the gain of
      keratinized mucosa. The present study will consist of a double-blind parallel randomized
      clinical trial to compare SCTG (control group) and CM (test group) in the treatment of
      Miller's class I and II gingival recessions, multiple in aesthetic areas (central incisors,
      Lateral, upper canine). All measurements will be evaluated initially and in the periods of 3,
      6, and 12 months after the surgical procedure.
    

Intervention name(s): Root coverage surgery
Intervention type(s): Procedure
Intervention description(s): Periodontal plastic surgery aiming the treatment of multiple gingival recessions in aesthetics areas with SCTG and CM
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Gingival Recession; Collagen Matrix; Periodontics
A Nutrition Intervention for Arthritis -4 (WCCR-ARTH4)
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Interventional

Summary: 
      The purpose of the study is to assess whether, in individuals with rheumatoid arthritis, a
      low-fat, vegan diet improves pain and other subjective symptoms more effectively than a
      control supplement or a placebo. The principal measure is pain as measured by Visual Analog
      Scale (VAS) and disease activity as measured by number of painful swollen and tender joints,
      respectively. The study duration is 36 weeks.

      This study tests that a low fat, plant-based (vegan) diet free of foods commonly identified
      as triggers improves mood, using the Center for Epidemiologic Studies Depression
      Scale-Revised (CESD-R), and the Beck Depression Inventory II (BDI-II).
    

Detailed description: 
      Preliminary evidence suggests that low-fat, vegetarian diets and certain nutritional
      supplements can help reduce pain and also reduce the need for pain medications for some
      people. The investigators will ask about 100 people to participate. All of them will get a
      low-fat, vegan diet and a nutritional supplement (mixture of omega-3 oils and vitamin E or a
      placebo), although some will get the diet first, and others will get the supplement first.
      This order in which they will get the diet and the supplement will be determined randomly,
      that is, by chance (like the toss of a coin). The principal measure is pain as measured by
      Visual Analog Scale (VAS) and disease activity as measured by number of painful swollen and
      tender joints, respectively. The Beck Depression Inventory II (BDI-II)will be used to measure
      changes in mood. The study duration is 36 weeks.
    

Intervention name(s): Plant-based diet; Supplement
Intervention type(s): Other; Dietary Supplement
Intervention description(s): Weekly instructions will be given to the participants in the intervention group about following vegan diet.; Unrestricted diet with clinically insignificant amount of omega- 3 oils and vitamin E
Other intervention name(s): Vitamin E
Intervention MeSH terms: Vitamin E
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Rheumatoid Arthritis; Diet; Fat-Restricted; Vegeterian
Icariin to Prevent Corticosteroid-related Memory Changes
Condition: the Pharmacokinetic Profile of Icariin in Humans
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to investigate the pharmacokinetic properties of icariin, an
      active ingredient in the over-the-counter supplement, Horny Goat Weed.
    

Detailed description: 
      The purpose of this study is to investigate the pharmacokinetic properties of icariin, an
      active ingredient in the over-the-counter supplement, Horny Goat Weed.

      Healthy volunteers will be randomly assigned to a 5 day course of icariin at 100 mg/day, 200
      mg/day, 400 mg/day, or 800 mg/day, or a matching placebo.

      24 hours of blood samples will be drawn for pharmacokinetic analysis. Side effects will be
      assessed for the full 5 days.
    

Intervention name(s): Icariin; Matching placebo
Intervention type(s): Drug; Dietary Supplement
Other intervention name(s): Horny Goat Weed; epimedium extract
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: icariin; pharmacokinetics; healthy participants
Evaluation of the Nextdoor KIND Challenge
Condition: Loneliness; Social Isolation
Study type: Interventional

Summary: 
      There is ample evidence showing that loneliness is a public health problem that influences
      social, mental and physical health. The current project is about evaluating the effectiveness
      of the Kindness Is NextDoor (KIND) Challenge, a social networking platform aimed at reducing
      loneliness and social isolation in specific Nextdoor communities within Australia. As the
      landscape through which people make social connections changes due to technology it is
      important to evaluate the effectiveness of platforms that are designed to reduce loneliness
      within communities. This is the first study of its kind in Australia and will help provide
      insight into how to target social isolation and loneliness within communities using social
      networking platforms.
    


Intervention name(s): KIND Challenge
Intervention type(s): Behavioral
Intervention description(s): The KIND challenge consists of nominating an activity to complete over a 4 week period. The activities involve doing an activity with others in your neighbourhood. These activities are positive, engaging and feasible to the average individual. Activities adhere to relevant country or state department health and safety guidelines. For example; having a chat with a neighbour online, or bringing in rubbish bins for an elderly neighbour.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
An Open-Label, FIH Study Evaluating the Safety and Tolerability of VCTX210A Combination Product in Subjects With T1D
Condition: Diabetes Mellitus; Diabetes Mellitus, Type 1; Glucose Metabolism Disorders; Metabolic Disease; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1; Metabolic Diseases; Glucose Metabolism Disorders; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases
Study type: Interventional
Phase: Phase 1

Summary: 
      This is an open-label, multicenter, Phase 1 study evaluating the safety and tolerability of
      VCTX210A combination product in patients with T1D
    

Detailed description: 
      VCTX210A combination product (unit) comprises 2 components: (1) allogeneic pancreatic
      endoderm cells (PEC210A) genetically modified using Clustered Regularly Interspaced Short
      Palindromic Repeats/CRISPR-associated protein 9 (CRISPR/Cas9) to promote immune evasiveness
      and survival, and (2) a durable, removable, perforated device designed to deliver and retain
      the PEC210A cells.
    

Intervention name(s): VCTX210A unit
Intervention type(s): Combination Product
Intervention description(s): CRISPR-Cas9 genetically modified PEC210A cells loaded into a delivery device
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Type 1 Diabetes; T1D; Allogeneic; Combination Device; CRISPR-Cas9; Cell Therapy; T1DM; Diabetes; VCTX
The Study Aims to Show Bioequivalence of the Test Product and the Reference Reference Product in a Crossover Design Study Healthy Volunteers. Additionally, the Safeyt Profile of Test Product Compared to Reference Product Will be Assessed.
Condition: Diabetes Mellitus
Study type: Interventional

Summary: 
      To evaluate and compare the relative bioavailability and therefore the bioequivalence of
      Vildagliptin Tablets 50 mg of AET Laboratories Private Limited, India, with GALVUS® 50 mg
      Tablets of Novartis Europharm Limited, United Kingdom, in normal, healthy, adult, male human
      subjects under fasting conditions and to evaluate the safety and tolerability of Vildagliptin
      Tablets 50 mg in normal, healthy, adult, male human subjects under fasting conditions.
    


Intervention name(s): Vildagliptin 50 MG
Intervention type(s): Drug
Intervention description(s): 50 mg Vildagliptin as single-dose per study period
Intervention MeSH terms: Vildagliptin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Duration of ColdZyme® II
Condition: Common Cold
MeSH terms: Common Cold
Study type: Interventional

Summary: 
      The objective of this investigation is to verify that ColdZyme® is deposited onto the throat
      and estimate the half-life of the ColdZyme® solution in the oropharynx of human volunteers
      using a log-linear mixed-effects model (LMM).
    

Detailed description: 
      The study is an Open Label, Non-Comparative study intended to verify the method used to
      measure the duration of ColdZyme®. Each participant will be his own control as samples are
      taken before application of ColdZyme and used as an internal control. Samples will be taken
      from the oropharyngeal membrane using a cotton swab before application, and 1, 3, 5, 10, 20,
      and 60 minutes after application. Glycerol will then be extracted from the swabs using water
      and the concentration of glycerol will be measured.
    

Intervention name(s): ColdZyme
Intervention type(s): Device
Intervention description(s): ColdZyme is a Class I medical device (CE-marked) with the following composition: glycerol, water, Tris buffer, CaCl2, menthol and trypsin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
The Application of Neuromodulation in Sciatic Nerve
Condition: Healthy
Study type: Interventional

Summary: 
      The objective of this study will be to analyze the muscle activity of the short head (SHBF)
      and long head of the biceps femoris (LHBF) after the application of ultrasound-guided
      percutaneous neuromodulation (NMP) in the tibial or common fibular nerve compartment of the
      sciatic nerve.

      Authors will recruit healthy subjects and they will receive asymmetric biphasic rectangular
      current through a needle into the sciatic nerve. The sample was divided into two groups: one
      to which the technique was applied in the lateral compartment and another group, in the
      medial compartment of the nerve. The protocol used was 5 seconds of stimulation, 55 seconds
      of rest for 5 minutes at a frequency of 100 Hz and a phase duration of 350 microseconds. The
      electrical activity (recruitment of muscle fibers and maximum contraction) of the SHBF and
      LHBF and the muscle strength of the knee flexors were recorded by requesting the participants
      isometric flexion of the knee in the prone position. The percentage of change of each
      variable was also analyzed.
    


Intervention name(s): Neuromodulation
Intervention type(s): Other
Intervention description(s): Ultrasound-guided percutaneous neuromodulation will be applied. The protocol used was 5 seconds of stimulation, 55 seconds of rest for 5 minutes at a frequency of 100 Hz and a phase duration of 350 microseconds
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Health Services Research
The Effects of Intraoperative Esketamine on Postoperative Pain and Mood in Patients With Inflammatory Bowel Disease
Condition: Crohn Disease; Depression; Esketamine
MeSH terms: Crohn Disease; Depression
Study type: Interventional
Phase: Phase 4

Summary: 
      Crohn's disease (CD) is a chronic inflammatory disease of the gastrointestinal tract with
      symptoms evolving in a relapsing and remitting manner. Typically, the peak incidence of CD is
      18 to 35 years , which means that patients with CD will be plagued by the disease during
      their most precious years, and nearly 35% of them will develop depressive symptoms. For 70%
      of patients with CD who need surgery, the incidence of preoperative depression may be higher.
      The CD cohort with diagnosable psychological condition has been shown to experience a higher
      rate of disease exacerbation than the CD cohort without psycho complication. At the same
      time, this depressive mood may make postoperative recovery more difficult, so it is necessary
      to alleviate postoperative depression.

      Ketamine, a widely used anesthetic, is also used to treat depression. The most used ketamine
      in clinical practice is racemic ketamine, but its use is associated with many complications
      such as psychotic adverse effects and neurotoxicity. In recent years, S-ketamine has received
      attention for better efficacy and fewer complications . In 2019, the Food and Drug
      Administration (FDA) approved S-ketamine nasal spray for the treatment of refractory
      depression and subsequently received approval from numerous health authorities around the
      world. This proves that S-ketamine can provide a rapid antidepressant effect in patients with
      depression in a non-surgical setting. However, it is inconclusive whether S-ketamine affects
      surgical patients, mainly because of differences in the type of surgery, the dosage
      administered, the interaction with analgesics, and the evaluation tools implemented. Studies
      have shown that small doses of S-ketamine in breast cancer surgery and cervical cancer
      surgery can reduce postoperative depression. However, the effects of S-ketamine on
      postoperative depression (POD) and pain in patients with CD have not been studied.
    


Intervention name(s): Esketamine; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Esketamine; Placebo
Intervention MeSH terms: Esketamine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Confocal Raman Spectroscopy: in Vivo Measurement of Physiological Skin Parameters
Condition: Dermatologic Disorders; Disorder of Cholesterol Metabolism
MeSH terms: Skin Diseases
Study type: Interventional

Summary: 
      The purpose of this study is to

      I. determine several skin parameters, for example natural moisturizing factor (NMF) and
      cholesterol, with Raman spectroscopy in vivo and

      II. compare the results with the corresponding cholesterol levels measured in venous blood.
    

Detailed description: 
      In vivo Raman experiments will be carried out weekly on voluntary participants using a
      RiverDiagnostics gen2-SCA Skin Composition Analyzer (RiverDiagnostics, Rotterdam,
      Netherlands). All experiments will be carried out on the volar forearm. Semi-quantitative
      concentration profiles for several skin parameters will be determined, for example natural
      moisturizing factor (NMF) and cholesterol.

      Additionally the total cholesterol level will be detected by venous blood sample analysis.
      The blood samples will be taken weekly within two weeks, similar to the Raman measurements.
    

Intervention name(s): Venous blood collection; Raman spectroscopy
Intervention type(s): Procedure; Procedure
Intervention description(s): weekly within two weeks; weekly within two weeks, on the volar forearm, using a RiverDiagnostics gen2-SCA Skin Composition Analyzer
Intervention model: Single Group Assignment
Masking: None (Open Label)
Keywords: skin parameters; cholesterol; Raman spectroscopy
The Effects of Peanuts and Peanut Products on Glucose Control and Vascular Function
Condition: Cardiovascular Disease
MeSH terms: Cardiovascular Diseases
Study type: Interventional
Phase: Phase 1

Summary: 
      Pilot study data have demonstrated that peanuts ameliorate the postprandial glucose and
      insulin response when incorporated into an acute high fat/high glucose meal. However, it is
      unclear whether acute consumption of peanuts can also influence vascular function. This study
      will therefore evaluate the effects of acute peanut consumption on vascular function,
      glycemic control, and plasma lipids. The hypothesis is that that addition of peanuts to a
      high fat/high glucose meal will reduce the production of triglycerides, glucose, and improve
      endothelial function as measured by flow-mediated dilation (FMD).
    


Intervention name(s): Control; Peanut
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): 34.8 g dextrose, 150 g heavy whipping cream, 39g chocolate syrup, 15 g sunflower oil, 22 g safflower oil, 27 g powdered egg whites, 9.6 g of fiber supplement, water and crushed ice. It will deliver ~1200 kcal.; 34.8 g dextrose. 137 g heavy whipping cream, 39g chocolate syrup + 3 oz peanuts with skin. It will deliver ~1200 kcal.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Effect of Acetazolamide on Postural Control in Patients With Respiratory Disease at Altitude
Condition: Chronic Obstructive Pulmonary Disease
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Study type: Interventional
Phase: Phase 4

Summary: 
      In this trial, the investigators will evaluate the effect of acetazolamide (375 mg per day)
      vs. placebo on postural control at acute altitude exposure in patients with COPD.
    

Detailed description: 
      This is a randomized, placebo-controlled, double-blind parallel trial evaluating the effect
      of acetazolamide (375 mg per day) vs. placebo on postural control at altitude (Tuja Ashu,
      3200 m). Participants living in the Bishkek area, Kyrgyzstan (760m), will be transferred by
      car within 4h to the Tuja Ashu high altitude clinic (3200 m), and stay there for 2 days.
      Acetazolamide 375mg/day (or placebo) will be administered 24 hours before departure at 760 m
      and during the stay at altitude. Outcomes will be assessed during the stay at 3200 m.
      Randomization to acetazolamide or placebo will be carried out after baseline measurements in
      Bishkek (760 m).

      Postural control will be assessed by a rectangular, stable balance platform (Wii Balance
      Board) measuring the body's center of gravity. The movement of the body's center of gravity
      will be recorded in a two-dimensional coordinate system and indicated as path length.
    

Intervention name(s): ACETAZOLAMIDE oral capsule; Placebo oral capsule
Intervention type(s): Drug; Drug
Intervention description(s): Administration of 125mg acetazolamide in the morning, 250mg in the evening, starting 24 hours before departure to 3200m; Administration of equally looking placebo capsules in the morning and evening, starting 24 hours before departure to 3200m
Intervention MeSH terms: Acetazolamide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: postural control; balance performance; airway disease; altitude; prevention; acetazolamide
Study to Evaluate the Drug-drug Interactions Between Metformin and AMG 510 in Healthy Participants
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objectives of this study are to evaluate the effect of AMG 510 on the
      pharmacokinetics (PK) of metformin in healthy participants and to evaluate the effect of
      metformin on the PK of AMG 510 in healthy participants.
    


Intervention name(s): AMG 510; Metformin
Intervention type(s): Drug; Drug
Intervention description(s): Oral tablet; Oral tablet
Intervention MeSH terms: Metformin; Sotorasib
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Healthy volunteers; AMG 510; Metformin