bioihbjkbjnl/mcl2 huggingface dataset:
A Study of LY2951742 in Healthy Volunteers
Condition: Migraines
Study type: Interventional
Phase: Phase 1

Summary: 
      To evaluate the safety and tolerability of LY2951742 given as single or multiple subcutaneous
      injection in healthy male subjects
    


Intervention name(s): LY2951742; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Administered subcutaneously; Administered subcutaneously
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Other
Keywords: pain; neuropathic pain; headaches
Medi-Port Pilot Randomized Controlled Trial
Condition: Actively Undergoing Cancer Treatment; 4-9 Years of Age; At Least 1 Month From Diagnosis; Able to Speak and Understand English; Presenting to Clinic for at Least a 2nd Subcutaneous Port Needle Insertion
Study type: Interventional

Summary: 
      Pain is a frequent and significant problem related to cancer-directed treatment in children.
      Children with cancer often cite needle procedures as the most distressing experience caused
      by cancer and its treatment. Recently it has been shown that an interactive humanoid robot is
      capable of facilitating distraction and reducing distress during childhood immunizations. Our
      research objectives are to: (1) assess the feasibility of implementing the robot (Medi-Port)
      for effectiveness testing in a future RCT (measured as implementation outcomes) and (2)
      determine treatment effectiveness estimates (measured as preliminary effectiveness outcomes),
      compared to standard medical care.
    

Detailed description: 
      A sample of 40 children with cancer between the ages of 4-9 years (20 participants per
      treatment arm; 10 boys and 10 girls per treatment arm) will be recruited. The feasibility of
      the trial protocol to evaluate the impact of distraction via the humanoid robot on pain
      intensity and distress during SCP needle insertion compared to an active control in children
      with cancer will be explored. The effectiveness outcome includes the examination of the robot
      programmed to distract children during the procedure, reduce pain intensity and distress
      compared to an active control intervention (i.e. dancing robot).
    

Intervention name(s): Medi-Port; Medi-Port
Intervention type(s): Device; Device
Intervention description(s): Treatment; Control
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Menthol Flavored E-cigarette Use During a Simulated Ban of Menthol Cigarettes
Condition: Tobacco Use Disorder
MeSH terms: Tobacco Use Disorder
Study type: Interventional

Summary: 
      The purpose of this formative study is to provide preliminary data regarding how the
      availability of menthol flavored e-cigarettes affects tobacco use behavior in the context of
      a ban on menthol flavored cigarettes
    


Intervention name(s): menthol flavored e-cigarette; tobacco flavored e-cigarette
Intervention type(s): Other; Other
Intervention description(s): menthol flavored e-cigarette; tobacco flavored e-cigarette
Intervention MeSH terms: Menthol
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Effects of 23-gauge Lensecotomy Combined With Anterior Vitrectomy on Macular in Children With Congenital Cataract
Condition: Macular; Congenital Cataract
MeSH terms: Cataract
Study type: Interventional

Summary: 
      Congenital cataract is the main cause of form deprivation amblyopia in children. Current
      studies confirm that form deprivation amblyopia affects the macular development. However,
      there are different opinions about the effect of amblyopia on the macular thickness .
      Investigators have performed "cataract extraction with IOL implantation" on children with
      bilateral and unilateral congenital cataract. Investigators used OCT biometry to measure
      children's the macular thickness before and after surgery..Average sectional total thickness
      was automatically determined by the instrument's software using a modified Early Treatment
      Diabetic Retinopathy Study (ETDRS) circle grid (fovea, inner ring, and outer ring: 1 mm, 3
      mm, and 6 mm. Investigators dynamically observed changes in macular to explore the retinal
      mechanism of form deprivation amblyopia and help guide the clinical correct understanding of
      postoperative follow-up time.
    


Intervention name(s): cataract surgery
Intervention type(s): Procedure
Intervention description(s): To measure the MT in congenital cataracts before and after the cataract extraction with IOL implantation surgery
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: macular thickness
A Study to Evaluate the Impact of Using Warm Compress Prior to Daily Injections of Copaxone®
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis
Study type: Interventional
Phase: Phase 4

Summary: 
      This study is designed to compare skin reactions with or without the use of warm compress
      prior to performing a Copaxone® injection.
    


Intervention name(s): glatiramer acetate; Warm compress prior to injection of glatiramer acetate
Intervention type(s): Drug; Procedure
Other intervention name(s): Copaxone; Copaxone
Intervention MeSH terms: Glatiramer Acetate; (T,G)-A-L
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Surgeons' Satisfaction With the Surgical Training Program in Egypt
Condition: Satisfaction
Study type: Observational

Summary: 
      In Egypt, the evidence for quality processes has not been established yet in the current
      training programs for surgery residents. There are no published articles discussing career
      satisfaction among surgical residents. Therefore, we are going to conduct a self-designed
      survey in Egyptian university hospitals to measure residents' satisfaction and display views
      about their undergraduate surgical education, surgical education during internship year,
      post-graduate training program, and extracurricular activity during medical school.
    


Observational model: Ecologic or Community
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        Residents (juniors, sub-seniors, seniors) and assistant lectures in all surgical
        specialities.
      
Keywords: Satisfaction; Training program; Egypt; Cross-sectional; Multi-center
Bioequivalence Study of Levocetirizine DiHCl Tablets 5mg of Dr. Reddy's Under Fed Conditions
Condition: Healthy
MeSH terms: Malnutrition
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess the Bioequivalence of Levocetirizine DiHCl Tablets 5mg
      with XYZAL tablets 5 mg and to monitor clinical status, adverse events and laboratory
      investigations and assess relative safety and tolerance, under fed conditions.
    

Detailed description: 
      A pivotal study to compare the Bioequivalence of Levocetirizine DiHCl Tablets 5 mg of
      Dr.Reddy's Laboratories Limited with XYZAL® Tablets 5 mg of UCB Farchim S.A. in healthy,
      human subjects under fed conditions.
    

Intervention name(s): Levocetirizine DiHCl
Intervention type(s): Drug
Intervention description(s): Levocetirizine DiHCl Tablets 5 mg
Other intervention name(s): XYZAL
Intervention MeSH terms: Levocetirizine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Bioequivalence; Levocetirizine; Crossover
Harnessing Placebo Effects: Non-Deceptive Use of Placebo in Irritable Bowel Syndrome (IBS)
Condition: Irritable Bowel Syndrome
MeSH terms: Irritable Bowel Syndrome; Syndrome
Study type: Interventional

Summary: 
      Irritable bowel syndrome patients will be given either placebo pill or no treatment for a
      period of 3 weeks.
    

Detailed description: 
      Seventy patients with irritable bowel syndrome (IBS) will be randomized to either 1) placebo
      pill or 2) no treatment and followed for 3 weeks. The study will involve three visits:
      baseline, midpoint and end point. At baseline all patients will physical examination, be
      evaluated for IBS and be administered standardized IBS questionnaires including: "IBS
      adequate relief" questionnaire, IBS global symptom improvement scale, IBS quality of life and
      IBS symptom severity scale. At midpoint and endpoint the same questionnaires will be
      administered. Patients on no treatment will be offered education on managing IBS at the end
      of the study.
    

Intervention name(s): Sugar pill
Intervention type(s): Other
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: irritable bowel syndrome; no organic digestive disease
Improving Diet Protein Intake in Middle-aged Women
Condition: Dietary Habits
Study type: Interventional

Summary: 
      The study sought to examine the effectiveness of nutrition education with and without diet
      coaching on dietary protein intake and muscle mass, strength and function among a group of
      middle-aged women.
    

Detailed description: 
      The study sought to examine the effectiveness of nutrition education alone and with 10 weeks
      of diet coaching on dietary protein intake and muscle mass, strength and function among a
      group of middle-aged women.
    

Intervention name(s): Coached
Intervention type(s): Behavioral
Intervention description(s): 10-weeks of diet coaching weekly by telephone to improve dietary protein intake
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Protein intake, coaching, strength
A Safety Study of IMOVAX Polio Vaccine in Selected Cities in China
Condition: Polio; Poliomyelitis
MeSH terms: Poliomyelitis
Study type: Interventional
Phase: Phase 4

Summary: 
      The aim of the study is to collect post marketing safety data on IMOVAX Polio vaccine in
      China.

      Objective:

      To describe serious adverse events 30 days after each dose of IMOVAX Polio™ administered at
      2, 3, and 4 months of age among infants living in the study cities of China.
    

Detailed description: 
      Each study participant will receive an IMOVAX Polio™ injections at 2, 3 and 4 months of age
      (total of 3 doses) and will be followed up for 30 days after each vaccination.
    

Intervention name(s): IMOVAX Polio™: Inactivated Poliomyelitis Vaccine
Intervention type(s): Biological
Intervention description(s): 0.5 mL, Intramuscular
Other intervention name(s): IMOVAX Polio™
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Polio; Poliovirus; IMOVAX Polio™
A Study of SM04554 Applied Topically to the Scalp of Male Subjects With Androgenetic Alopecia Analyzed by Biopsy of the Scalp Prior To and Post Dosing
Condition: Androgenetic Alopecia
MeSH terms: Alopecia; Alopecia Areata
Study type: Interventional
Phase: Phase 2

Summary: 
      This study will assess the safety, tolerability, and efficacy of SM04554 at concentrations of
      0.15% and 0.25%. Improved knowledge of the changes in hair counts and immunohistochemical
      analysis associated with androgenetic alopecia (AGA) before and after treatment with SM04554
      and compared to placebo may lead to a greater understanding of the underlying mechanisms of
      action of SM04554.
    


Intervention name(s): Topical SM04554 solution; Topical Vehicle solution
Intervention type(s): Drug; Drug
Intervention MeSH terms: Pharmaceutical Solutions
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: male pattern baldness; SM04554; AGA
The Use of Oxytocin, Carbetocin and Buccal Misoprostol in Patients Undergoing Elective Cesarean Section (CS)
Condition: Postpartum Hemorrhage
MeSH terms: Postpartum Hemorrhage; Hemorrhage
Study type: Interventional
Phase: Phase 3

Summary: 
      The use of Oxytocin, Carbetocin and buccal misoprostol in patients undergoing elective
      Cesarean Section
    

Detailed description: 
      The use of Oxytocin, Carbetocin and buccal misoprostol in patients undergoing elective
      Cesarean Section in the prevention of uterine atony and postpartum hemorrhage (PPH) after
      caesarean section.
    

Intervention name(s): Syntocinon; Carbetocin; Misoprostol
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Syntocinon ampoules (10 IU Oxytocin). (Novartis Pharma, Egypt) One ampoule 10 IU diluted in 10 ml normal saline and administered slowly (over 30- 60 seconds) intravenously just after delivery of the neonate during CS, followed by an intravenous drip of 20 IU oxytocin in 500 ml saline over 4 hours.; Carbetocin (Ampoule 100 μg/ml) . [Pabal, Marketing Authorization Holder: Ferring GmbH (Gesellschaft mit beschränkter Haftung), Kiel ,Germany. Manufactured by DRAXIS Pharma , a division of specialty Pharmaceuticals Inc. Montreal ,Canada] ,diluted in 10 ml normal saline and administered slowly (over 30- 60 seconds) intravenously just after delivery of the neonate during CS.; Misoprostol (200 mcg Tablet) [Misotac, Sigma Pharmaceutical Industries, SAE, Egypt] Two tablets (400 mcg) in the buccal space just after delivery of the neonate during CS.
Other intervention name(s): Pabal; Misotac
Intervention MeSH terms: Misoprostol; Oxytocin; Carbetocin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: caesarean section, ecbolics, postpartum hemorrhage
AZD2171 in Addition to Fulvestrant in Patients With Advanced Breast Cancer.
Condition: Advanced Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine whether AZD2171 can effectively improve time to
      tumour progression when added to fulvestrant in patients with advanced hormone sensitive
      breast cancer who progressed on prior hormonal therapy.
    


Intervention name(s): AZD2171; Fulvestrant
Intervention type(s): Drug; Drug
Intervention description(s): Oral tablet; intramuscular injection
Other intervention name(s): Recentin; Faslodex; ZD9238
Intervention MeSH terms: Fulvestrant; Cediranib
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Advanced Breast Cancer
CGM - Reimagine Primary Care
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 4

Summary: 
      To assess the impact of continuous glucose monitoring versus standard of care (e.g. a
      finger-prick protocol using a glucometer) on clinical outcomes, healthcare utilization, and
      cost in patients with type I or II diabetes treated within the Reimagine Primary Care
      clinics.
    

Detailed description: 
      This is a parallel randomized controlled trial. Eligible patients who consent will be
      randomized to one of two groups: (1) the intervention group who will be given a Dexcom G6 for
      CGM, or (2) the control group who will follow their current standard finger-prick protocol
      via a provided Contour Next ONE glucometer. The CGM group must download the Dexcom G6 and
      Clarity mobile apps for data capture, whereas the standard of care group will use the Contour
      Next mobile app for their respective readings.

      The Dexcom G6 captures real-time, dynamic glucose data every five minutes. Devices used in
      this study are FDA approved and commercially available.
    

Intervention name(s): Dexcom G6; Contour NextOne
Intervention type(s): Device; Device
Intervention description(s): Continuous Glucose Monitor that, after applied, sends continuous glucose readings to to the patient's smartphone every 5 minutes. This allows the patients to receive more readings over a 24 hour period versus standard of care glucometer finger sticks.; A Standard of Care Glucometer with Bluetooth capability. The patient inserts a test strip into the device, takes a finger stick and collects a small blood sample on the tip of the strip to initiate the device to detect a glucose reading.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Parallel Randomized Control Trial
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Continuous Glucose Monitor (CGM); Dexcom G6
Effects of Moderate Physical Activity on Glycemic Control in Type 2 Diabetes Mellitus
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      The study design is to determine the effectiveness of moderate physical activity on g;lycemic
      control in type 2 diabetes mellitus.
    

Detailed description: 
      To the best of authors knowledge so far the studies have been conducted on different modes of
      moderate physical activity on glycemic control in type 2 diabetes, current study goal is to
      evaluate which mode of moderate physical activity has more significant result on glycemic
      control in type 2 diabetes and is sustainable in Pakistani society according to the
      socioeconomic status and cost effectiveness of the modes of moderate physical activity.
    

Intervention name(s): Brisk Walk; Strength training; Aerobic Exercises
Intervention type(s): Other; Other; Other
Intervention description(s): 1-Brisk walk for 30 minutes 2-5 days a week 3-3months; 1-Strength Training Exercises for 30 minutes. 2-5 days a week 3-3 months; 1-Aerobic exercises for 30 minutes 2-5 Days a week 3-3months
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Other
Closed-Loop With Faster Aspart in Young Adults With Type 1 Diabetes
Condition: Type 1 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional

Summary: 
      A randomized, double-blinded (for insulin type), single centre, crossover design young adult
      study, on 20 subjects with type 1 diabetes (T1D), aged 18 to 25 (inclusive) years, measuring
      time in glucose values within 3.9 - 10 mmol/l (70-180 mg/dl) under supervision of DreaMed
      Glucositter using either faster-acting insulin Aspart (Fiasp®, European Medicines Agency
      number EMEA/H/C/004046) or normal acting insulin Aspart.

      Study duration will be about 3 weeks per subject, 5 month overall.

      The objectives of this clinical investigation is:

      1. to evaluate the safety and efficacy of blood glucose control using the DreaMed Glucositter
      with Fiasp® in young adults with T1D during and after unannounced afternoon physical activity
      and unannounced meals, in a controlled in-hospital environment.

      Primary endpoint is significant between-group difference (intervention Fast-CL versus control
      Regular-CL) in time within range of glucose values within 3.9 - 10 mmol/l (70-180 mg/dl)
      during the unannounced afternoon exercise and unannounced standardized meals from 15:00 till
      18:00 next day based on sensor glucose readings.
    


Intervention name(s): Fast-CL; Regular-CL
Intervention type(s): Drug; Drug
Intervention description(s): After the admission we will insert new insulin (blinded) into the insulin pump. At 13:00 they will have lunch (with manual bolus). At 15:00 we will start CL control, participants/investigators will not be allowed to deliver manual bolus till the end of the study period. All meals and afternoon exercise (in the time between 16:30 and 19:30) will be unannounced and managed with CL.; After the admission we will insert new insulin (blinded) into the insulin pump. At 13:00 they will have lunch (with manual bolus). At 15:00 we will start CL control, participants/investigators will not be allowed to deliver manual bolus till the end of the study period. All meals and afternoon exercise (in the time between 16:30 and 19:30) will be unannounced and managed with CL.
Other intervention name(s): Faster Acting Insulin Aspart and DreaMed Glucositter; Insulin Aspart and DreaMed Glucositer
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Insulin Aspart; Insulin, Long-Acting; Insulin degludec, insulin aspart drug combination
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Phase 1 Study of ANAVEX3-71
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      A first in human phase 1 study in healthy volunteers to assess ANAVEX3-71 safety,
      tolerability, bioavailability, pharmacokinetics, and pharmacodynamics
    

Detailed description: 
      This is a first-in-human Phase 1 study designed to investigate the safety, tolerability, PK,
      PD and bioavailability of orally administered ANAVEX3-71 in healthy volunteers
    

Intervention name(s): ANAVEX3-71; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Active oral dose of ANAVEX3-71; Oral placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Vitamin/Mineral Absorption From Two Different Supplements
Condition: Healthy Nutrition
Study type: Interventional

Summary: 
      The objective of this project is to evaluate the postprandial serum and plasma vitamin and
      mineral levels in healthy adult men and women between 18 and 32 years of age, following a
      single intake of a multivitamin and mineral supplement processed in two different ways.
    

Detailed description: 
      Serum or plasma levels of five vitamins and four minerals will be measured at baseline, and
      1, 2, 4, and 6 hours after the intake of a multivitamin/mineral supplement processed by two
      different methods. The two methods involve using either conventional isolated vitamins and
      minerals blended together to provide approximately 100% of the Daily Value, or using the same
      amount of vitamins and minerals that have first been processing into liposomal forms before
      blending.

      Participants are required to come for two study visits which are 5 to 7 days apart. Health
      screening will also be done at Study Visit 1. The order of supplement assignment will be
      randomized, performed in a double-blind manner.
    

Intervention name(s): Multivitamin/mineral supplement A; Multivitamin/mineral supplement B
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Oral administration of Supplement A; Oral administration of Supplement B
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Participants will be randomly assigned to receive either supplement A or supplement B during the first visit. Five to seven days later, participants will receive the other supplement.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Other
Keywords: Minerals; Vitamins; Absorption
A Single Dose Study of DWP10292 in Healthy Male Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate safety, tolerability, pharmacokinetics and
      pharmacodynamics of orally administrated DWP10292 in healthy male volunteers.
    


Intervention name(s): DWP10292; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Drug: DWP10292 tablets, oral administration, single administration; Placebo tablets, oral administration, single administrations
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Basic Science