bioihbjkbjnl/mcl2 huggingface dataset:
A Safety Study of ARRY-403 in Patients With Type 2 Diabetes
Condition: Type 2 Diabetes
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a Phase 1 study, involving a 1-day dosing period, designed to test the safety of
      investigational study drug ARRY-403 in patients with Type 2 diabetes. Approximately 36
      patients from the US will be enrolled in this study.
    


Intervention name(s): ARRY-403, glucokinase activator; oral; Placebo; oral
Intervention type(s): Drug; Drug
Intervention description(s): single dose, escalating; matching placebo
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Effectiveness of an Oral Feeding Educational Nurse Program on Feeding Performance in Preterm Neonates
Condition: Preterm Neonates and Feeding
MeSH terms: Premature Birth
Study type: Observational

Summary: 
      Poor oral motor development in preterm neonates is common. Feeding problems lead to longer
      hospital stay and higher hospital cost. Different interventions have shown their efficacy to
      accelerate transition and move faster to full oral feeding autonomy. Our study aimed to
      evaluate the impact of a 2-year education nurse program on feeding pattern and hospital stay
      of preterm neonates.

      This is an interrupted time series study placed in Intensive Care and Neonatal unit of an
      university hospital located in Lyon, France. All preterm neonates are included in the study,
      from April 2013 to January 2016.
    


Intervention name(s): Educational oral feeding nurse program
Intervention type(s): Other
Intervention description(s): A multidisciplinary group composed of childcare assistants, nurse guardians, speech therapist, physiotherapist, psychologist, and pediatricians will develop and implement the educational oral feeding program. They will provide the 2-day theoretical session as well as the three 2-hour practical sessions including reviews of video recording preterm neonates during bottle or breast feedings.
The program will focus on non-nutritive sucking for all neonates from 24 up to 34 weeks' of gestation, early oral feeding from 29 weeks' of gestation and oral stimulation for all preterm neonates admitted to the unit. Additionally, all preterm neonates presenting feeding difficulties symptoms will be evaluated weekly by a physiotherapist or speech therapist.
Each program session is composed of 20 nurses or childcare assistants. Six sessions will be organized in total and all nurses and childcare assistants will be trained
Observational model: Other
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Preterm neonates of less than 34 weeks' of gestation requiring no surgery with endotracheal
        intubation admitted to the Neonatology or Neonatal Intensive Care Unit of an university
        hospital, Lyon.
      
Keywords: Neonate; oral feeding disorder; full oral feeding; training; quality of health care
Comparison of the Efficacy and Safety of Two Topical Creams for Pediatric Atopic Dermatitis
Condition: Atopic Dermatitis
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema
Study type: Interventional
Phase: Phase 4

Summary: 
      This study compares the effectiveness of two topical creams for atopic dermatitis in
      pediatric subjects. Subjects will be randomly assigned to use one of the two creams twice
      daily for 6 weeks or until clear.
    


Intervention name(s): EpiCeram Skin Barrier Emulsion; Desonide Cream 0.05%
Intervention type(s): Device; Drug
Intervention description(s): topical cream, twice daily, 6 weeks; topical cream, twice daily, 6 weeks
Intervention MeSH terms: Desonide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Evaluation of the Effect of Rifampin and Rabeprazole on the Pharmacokinetics of Camlipixant
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a phase 1, 2-part, open-label, fixed-sequence study evaluating the effect of rifampin
      (part 1) and rabeprazole (part 2) on the pharmacokinetics of a single dose of camlipixant
      (BLU-5937) 50 mg tablet in healthy participants under fasting conditions.
    


Intervention name(s): Camlipixant + Rifampin; Camlipixant + Rabeprazole
Intervention type(s): Drug; Drug
Intervention description(s): Camlipixant will be administered alone as well as in co-administration with rifampin; Camlipixant will be administered alone as well as in co-administration with rabeprazole
Intervention MeSH terms: Rifampin; Rabeprazole
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Gut Derived Hormones, Body Composition and Metabolism in Prader-Willi Syndrome
Condition: Prader-Willi Syndrome
MeSH terms: Prader-Willi Syndrome; Syndrome
Study type: Interventional

Summary: 
      The purpose of this study is to investigate the effects of a GLP-1 agonist on satiety
      hormones in patients with Prader-Willi Syndrome (genetic defect causing obesity).
    

Detailed description: 
      Prader-Willi Syndrome (PWS) is the most frequent known genetic disorder of obesity.
      Hyperphagia is the main barrier to independent living in adults with PWS, and hitherto
      behavioural restraints and environmental modification are the only effective management
      measure. The emerging costs for professional care are immense. Thus, there is an urgent need
      for treatment which reduce appetite and food intake in this patient group. Agonists of the
      gut derived hormone GLP-1 which reduces food intake and causes weight loss due to slowed
      gastric emptying and through direct central effects. The aim of this pilot drug trial is to
      analyse the effect of a GLP-1 agonist on appetite regulating hormones, insulin secretion and
      energy expenditure before and after a meal.
    

Intervention name(s): Exenatide
Intervention type(s): Drug
Intervention description(s): 10ug Exenatide single s.c. injection
Intervention MeSH terms: Exenatide
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Photoirritation and Photoallergic Potential of a New Nicotine Patch
Condition: Smoking Cessation
Study type: Interventional
Phase: Phase 1

Summary: 
      An evaluation of the effects of UV exposure following the use of a new nicotine patch.
    

Detailed description: 
      An evaluation on the phototoxic potential of a newly developed nicotine patch after a single
      dose application followed by UV exposure, and an evaluation on the photoallergenic potential
      of the new nicotine patch after multiple dose applications followed by UV exposure.
    

Intervention name(s): Nicotine Patch; Placebo Patch; No Patch Control; UVA and UVB irradiation
Intervention type(s): Drug; Drug; Drug; Radiation
Intervention description(s): 25 mg nicotine patch applied on the assigned marked site on the lower back or buttock. Induction (23 days): six treatment applications for 24 h. Challenge (five days): one treatment application for 24 h.; As a positive control, a placebo patch applied on the assigned marked site on the lower back or buttock. Induction (23 days): six treatment applications for 24 h. Challenge (five days): one treatment application for 24 h.; As a negative control, a marked site on the lower back or buttock was assigned as test area, but no patch was applied.; All three test sites exposed to UV radiation after patch removal. Induction: 10 J/cm2 UVA and 0.5 MED UVB, one treatment after first patch removal; and 3 MED UVB at the 5 following treatments. Challenge: 4 J/cm2 UVA and 0.5MED UVB, one treatment.( MED: Minimal Erythema Dose determined during screening)
Other intervention name(s): Experimental Nicotine Patch; Positive Control; Negative Control; Irradiation
Intervention MeSH terms: Nicotine
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Screening
Safety, Tolerability, and Pharmacokinetics (PK) of Single and Multiple Ascending Oral Doses of XEN1101.
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The XEN1101 Phase 1 clinical trial is a randomized, double-blind, placebo-controlled study
      that will evaluate the safety, tolerability and PK of both single ascending doses (SAD) and
      multiple ascending doses (MAD) of XEN1101 in healthy subjects. In addition to safety and PK
      data, the clinical trial has been designed to include a pharmacodynamic read-out by
      incorporating a pilot transcranial magnetic stimulation (TMS) sub-study. The TMS model
      sub-study is designed to demonstrate delivery of XEN1101 into the central nervous system and
      to observe a change in cortical excitability as measured by EEG and/or electromyographic
      (EMG) activity.

      Part 3, 4 and 5: Phase 1, randomised, multi part study to evaluate the safety, tolerability,
      PK, relative bioavailability and food effect of single and multiple ascending doses of
      XEN1101 and Preliminary Drug-Drug Interaction Assessment with Itraconazole.
    

Detailed description: 
      Part 1 will study safety, tolerability, PK of single ascending doses (SAD) of XPF-008 as well
      as the impact and variability of single ascending doses of XPF-008 on TMS.

      Part 2 will study the safety, tolerability and PK of multiple ascending doses (MAD) of
      XPF-008

      Part 3 will explore dose proportionality of XPF-010 and confirm dosing for subsequent
      cohorts, and the food effect and relative bioavailability of XPF-010 compared to XPF-008.

      Part 4 will explore multiple dose PK.

      Part 5 will explore the drug-drug interaction of XPF-010, when given with itraconazole.
    

Intervention name(s): XPF-008; Microcrystalline Cellulose; XPF-010; Itraconazole 400mg
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Capsule filled with XEN1101; Placebo capsule; Capsule filled with XEN1101; Oral
Intervention MeSH terms: Itraconazole
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
A Study to Investigate the Effect of Esomeprazole and the Effect of Food on the Pharmacokinetics of Balovaptan in Healthy Volunteers
Condition: Autism Spectrum Disorder
MeSH terms: Autism Spectrum Disorder
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will investigate the effect of food and the effect of esomeprazole on the
      pharmacokinetics (PK) of a single dose of balovaptan in healthy volunteers.
    


Intervention name(s): Balovaptan; Esomeprazole
Intervention type(s): Drug; Drug
Intervention description(s): Balovaptan will be administered after a high-fat, high-calorie meal (Treatment A), after a 10-hour fast (Treatment B), and after a 10-hour fast with esomeprazole 40 mg (Treatment C); Esomeprazole will be administered once daily for 6 days and with a single dose of balovaptan 1 hour after the fifth esomeprazole dose
Intervention MeSH terms: Balovaptan; Esomeprazole
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Platelet Rich Plasma for Patients With Recurrent Implantation Failure
Condition: Infertility
MeSH terms: Infertility
Study type: Interventional
Phase: Early Phase 1

Summary: 
      Patients with recurrent implantation failure are among the most difficult patients to treat,
      with no proven standard treatment. Platelet rich plasma stimulates cellular processes
      involved in endometrial regeneration, and in a small case series has shown efficacy for this
      patient population. We hope to conduct a randomized controlled pilot study to determine
      whether PRP is indeed an effective treatment for recurrent implantation failure.
    

Detailed description: 
      Patients considered to have recurrent implantation failure will undergo randomization to
      receive intrauterine infusions of platelet rich plasma or a placebo of embryo culture media
      prior to their embryo transfer. All patients will undergo a blood draw to obtain 60ml of
      blood from which 0.5ml of platelet rich plasma will be obtained. Those randomized to receive
      the platelet rich plasma will have platelet rich plasma placed into the uterine cavity at
      least 48 hours prior to the embryo transfer, while those randomized to receive placebo will
      have embryo culture media placed into the uterine cavity at the same point in time. Those
      randomized to the placebo group will have the opportunity to be placed into the treatment
      group if no pregnancy was attained. Transfer outcomes including implantation rate, pregnancy
      rate, and live birth rate, will be recorded.
    

Intervention name(s): Platelet rich plasma; Placebo
Intervention type(s): Combination Product; Combination Product
Intervention description(s): Patients will have 60ml of blood drawn. Platelet rich plasma will be obtained by placing the blood in the Arteriocyte Magellan device. 0.5ml of Platelet rich plasma will be placed into the uterus at least 48 hours prior to embryo transfer.; Patients will have 60ml of blood drawn. 0.5ml of embryo culture media (the placebo) will be placed into the uterus at least 48 hours prior to embryo transfer.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Care Provider)
Primary purpose: Treatment
Keywords: Recurrent implantation failure
Body Image and Psychosocial Functioning in Women With Breast Cancer: Can We Fix What We've Broken?
Condition: Breast Neoplasms
MeSH terms: Breast Neoplasms
Study type: Interventional

Summary: 
      The purpose of this study is to test an innovative intervention geared towards issues of
      identity, body image and sexuality, and to examine the intervention for its impact on body
      image, quality of life, psychosocial/sexuality/relational functioning.
    

Detailed description: 
      Breast cancer is the most frequently diagnosed cancer in women with 1 in 10 Canadian women
      being diagnosed in their lifetime. There has been an increase in the number of survivors due
      to advances in treatment and early detection, and increased scientific attention has been
      focused on patients' quality of life during and after treatment. The majority of survivors do
      well after the initial adjustment within the first 2 years post-treatment. However, depending
      on when assessed after treatment completion, a wide range of cancer survivors either score at
      levels suggestive of a psychiatric diagnosis or are diagnosed with a psychological problem.
      Furthermore, a subset of survivors experience adjustment problems long after treatment
      completion. Approximately 20% to 40% of survivors develop sexual and body image problems
      following breast cancer and treatment and these difficulties tend to persist several years
      after treatment completion.

      This study aims to test an innovative intervention geared towards issues of identity, body
      image and sexuality and to examine the intervention for its impact on body image and quality
      of life, psychosocial and sexual functioning and relational functioning.

      One hundred and eighty women who have completed treatment for breast cancer will be
      randomized into either intervention: an 8 weekly psychosocial group support or control
      condition (standard care + written educational material). All subjects will be followed for 1
      year post-intervention. It is hypothesized that, compared to control subjects who receive
      standard care and educational materials, subjects participating in an 8 weekly psychosocial
      group support will have higher levels of relationship support/functioning, and that the group
      differences will be maintained over the 1-year follow up period.
    

Intervention name(s): Group Therapy Intervention
Intervention type(s): Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Keywords: Breast cancer,group psychotherapy,RCT,women's mental health
Usefulness of Lidocaine in Oral and Maxillofacial Surgeries Under General Anesthesia for Pain Control After Operation
Condition: Pain, Postoperative
MeSH terms: Pain, Postoperative
Study type: Interventional
Phase: Phase 4

Summary: 
      This will be a randomized double blinded clinical study conducted in patients undergoing oral
      and maxillofacial surgery under general anesthesia. Lidocaine group will receive intravenous
      bolus 1.5 mg/kg at induction followed by continuous infusion of 2 mg/kg/hr until the
      completion of surgery.Normal saline group will receive same amount of intravenous normal
      saline .The primary outcome will be postoperative pain using the NRS scale during first 24
      hours and time to first analgesic request
    


Intervention name(s): Lidocaine; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Postoperative analgesic effects will be compared between lidocaine and normal saline group; Postoperative anlagesic requirements will be calculated and compared with experimental group
Intervention MeSH terms: Lidocaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Analgesic Efficacy of Ultrasound-guided Transverse-abdominal Plain Blockade in Urological Surgery
Condition: Postoperative Pain
MeSH terms: Pain, Postoperative
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to compare pain level (according to numerical score)at 4, 8, 12
      and 24 postoperative hours between patients under transverse abdominal plain blockade (TAP)
      and patients under conventional analgesia. Also the opioid consumption is assessed.
    


Intervention name(s): Postoperative transverse abdominal plain (TAP) blockade
Intervention type(s): Procedure
Intervention description(s): Bupivacaine 0.25%. Maximum 150 mg. A maximum of 75 mg bupivacaine is administered in each side (posterior and subcostal TAP) in a single puncture.
Other intervention name(s): Buivacaine: Inibsicain (R) 0.25% (INIBSA, S.A.)
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Postoperative pain; Transverse abdominal blockade; Efficacy; Safety; Urology
To Evaluate Efficacy and Safety in TG-2349 Combination With DAG181 (± Ribavirin) in HCV Genotype I Infected Patients
Condition: Chronic Hepatics C Virus (HCV) Genotype 1; Non-Cirrhotic; Cirrhosis; Treatment naïve
MeSH terms: Liver Diseases
Study type: Interventional
Phase: Phase 2

Summary: 
      A phase II study to evaluate the efficacy and safety in TG-2349 combination with DAG181 (±
      Ribavirin) in treatment naïve subjects with chronic hepatic C virus genotype I infection.
    

Detailed description: 
      The purpose of this phase II study is to evaluate the efficacy and safety in TG-2349
      combination with DAG181 (± Ribavirin) in treatment naïve subjects with chronic hepatic C
      virus genotype I infection. Approximately 132 subjects will be enrolled in this study and
      divided into six groups:

      Group 1 to 4: Chronic hepatics C virus (HCV) genotype 1 infected, treatment naïve,
      non-cirrhotic subjects.

      Group 5 to 6: Chronic hepatics C virus (HCV) genotype 1 infected, treatment naïve, cirrhotic
      subjects.
    

Intervention name(s): non-cirrhotic subjects. low TG-2349+ low DAG181+Ribavirin; non-cirrhotic subjects. high TG-2349+ high DAG181+Ribavirin; non-cirrhotic subjects. low TG-2349+ low DAG181; non-cirrhotic subjects. high TG-2349+ high DAG181; cirrhotic subjects. high TG-2349+ high DAG181+Ribavirin; cirrhotic subjects. high TG-2349+ high DAG181
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): Group1: TG-2349 200 mg + DAG181 100 mg + Ribavirin 1000 mg or 1200 mg; Group2: TG-2349 400 mg + DAG181 200 mg + Ribavirin 1000 mg or 1200 mg; Group 3: TG-2349 200 mg + DAG181 100 mg; Group 4: TG-2349 400 mg + DAG181 200 mg; Group 5: TG-2349 400 mg + DAG181 200 mg + Ribavirin 1000 mg or 1200 mg_; Group6: TG-2349 400 mg + DAG181 200 mg
Intervention MeSH terms: Ribavirin; Yimitasvir
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Chronic hepatics C virus (HCV) genotype 1; treatment naïve; non-cirrhotic; cirrhotic; efficacy; safety; TG-2349; DAG181; Ribavirin
Trial on the Effect of Adalimumab on Vascular Inflammation in Patients With Psoriasis
Condition: Psoriasis; Vascular Inflammation; Coronary Atherosclerosis
MeSH terms: Atherosclerosis; Coronary Artery Disease; Myocardial Ischemia; Psoriasis; Inflammation
Study type: Interventional
Phase: Phase 4

Summary: 
      This study is a double-blinded randomized multicenter placebo controlled trial to determine
      the effect of adalimumab on vascular inflammation (ascending aorta and carotides) in patients
      with moderate to severe psoriasis.
    

Detailed description: 
      Patients with moderate to severe psoriasis will be included in this multicenter,
      double-blind, placebo controlled study. Patients will be randomized (1:1) at Day 0 to receive
      either adalimumab or placebo. Adalimumab will be administered sub-cutaneously as described in
      the Canadian product monograph (80mg followed by 40mg at Week 1 and 40mg every other week).
      At Week 16, all patients will receive two injections of blinded study products. Patients
      randomized to the placebo group will receive two injections of adalimumab (2 x 40 mg) and
      patients randomized to adalimumab will receive two injections of placebo. As of Week 17,
      patients randomized to the placebo group will receive 40 mg adalimumab every other week until
      Week 67. Patients randomized to the adalimumab group will continue to receive adalimumab 40mg
      every other week until Week 51.

      Efficacy will be assessed with 18-FluoroDeoxyGlucose Positron Emission Tomography (FDG-PET)
      scan and carotid MRI at baseline, Week 16 and Week 52 (or Week 68 for patients randomized to
      placebo).

      Safety will be assessed with physical examinations, vital signs, adverse events collection,
      routine laboratory examinations, pregnancy test, hepatitis B and C serology (screening),
      Purified Protein Derivative (PPD) or Quantiferon Gold (screening) and Chest X-Ray (CXR)
      (screening).
    

Intervention name(s): Adalimumab; Placebo
Intervention type(s): Biological; Other
Intervention description(s): Injection of adalimumab (80 mg followed by 40 mg at week 1 and 40 mg EOW thereafter for 52 weeks). For Adalimibab group and Placebo group.; Injection of placebo that is physicaly identical to adalimumab without the active ingredient at identical intervals.
Other intervention name(s): Humira
Intervention MeSH terms: Adalimumab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Psoriasis; Vascular Inflammation; Coronary Atherosclerosis; Ascending aorta; Pet scan; MRI