bioihbjkbjnl/mcl2 huggingface dataset:
Substance Misuse To Psychiatric Disorders for Cannabis
Condition: Cannabis Use Disorder; Depressive State; Anxiety State; Depression; Anxiety Disorders; Pharmacotherapy
MeSH terms: Marijuana Abuse; Depression; Anxiety Disorders; Mental Disorders; Problem Behavior
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      With the recent availability of vortioxetine, and the surging phenomenon of cannabis misuses
      amongst young abusers, it is a timely opportunity to conduct an early pharmacotherapy
      intervention study to offer an evidence-based strategy aiming to stop individuals with
      cannabis use disorders with depressive or anxiety symptoms, to develop into a more chronic
      disabling dependence or co-morbid state.
    


Intervention name(s): Vortioxetine; Treatment as Usual
Intervention type(s): Drug; Other
Intervention description(s): oral medication taken once daily; Any pharmacological or non-pharmacotherapy modalities other than use of vortioxetine
Intervention MeSH terms: Vortioxetine
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: prospective randomised single-blinded
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Cannabis; depression; anxiety; medication
Biomarkers Predicting Successful Tacrolimus Withdrawal and Everolimus (Zortress) Monotherapy Early After Liver Transplantation
Condition: Liver Transplantation
Study type: Interventional

Summary: 
      Most patients who get a liver transplant must take immunosuppressants for the rest of their
      lives. However, this has occurred at the expense of chronic CNI toxicity, e.g. chronic kidney
      disease (CKD), metabolic complications, infections and malignancy. Everolimus (EVL) is a drug
      that may stabilize or improve kidney function for patients with chronic kidney disease (CKD)
      that has been caused by immunosuppressants. EVL is used for standard of care treatment to
      prevent transplant liver rejection in combination with other immunosuppressants, such as
      tacrolimus. The overall aim of this study is to examine a combination of two different
      immunosuppressants and EVL to determine if patients may have stabilized and/or improved
      kidney function without liver rejection. This study will look at how safe it is to slowly
      withdraw one anti-rejection medication while continuing to take the other medicine, and
      whether this can be done without liver rejection occurrence.
    


Intervention name(s): Tacrolimus Withdrawal and Everolimus Monotherapy
Intervention type(s): Drug
Intervention description(s): During the first month post-transplant, the subject receives everolimus (about 5-8 ng/mL) and tacrolimus with or without mycophenolic acid as part of standard of care procedures. At one month post-transplant, mycophenolic acid will be stopped and tacrolimus dosage will be reduced while continuing the dosage of everolimus. At three months post-transplant, tacrolimus dosage will be reduced by 50% of the daily dose each week. At four months post-transplant, tacrolimus will be discontinued.
Intervention MeSH terms: Everolimus; Tacrolimus
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: liver transplantation; immunosuppression; everolimus; tacrolimus; kidney function; liver function; biomarkers
Better Days, Better Nights: Treatment for Sleep Difficulties (Telephone Coached)
Condition: Sleep Disorder
MeSH terms: Sleep Wake Disorders
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of the Strongest Families (formerly Family Help Program)is to evaluate the
      effectiveness of the Strongest Families distance intervention compared to usual or standard
      care that is typically provided to children with mild to moderate sleep onset latency and/or
      bedtime resistance difficulties. This is a single-centre trial based at the IWK Health
      Centre. The primary outcome is change in sleep patterns (sleep onset latency and/or bedtime
      resistance).
    

Detailed description: 
      The purpose of the Family Help Sleep Program is to deliver, primary care mental health
      services to children and their families in the comfort and privacy of their own home.
      Approximately 80 children (6-12 years of age)suffering from mild to moderate sleep onset
      latency and/or bedtime resistance will be randomized.

      The intervention is delivered from a distance, using an educational handbook and telephone
      consultation with a trained paraprofessional "coach" who is supervised by a licensed health
      care professional. The telephone coach delivers consistent care based on written protocols,
      with on-going evaluation by a professional team.
    

Intervention name(s): FHP Sleep Program
Intervention type(s): Behavioral
Intervention description(s): Cognitive-Behavioral Intervention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: sleep onset latency; bedtime resistance
Phase II Study of Digitoxin to Treat Cystic Fibrosis
Condition: Cystic Fibrosis
MeSH terms: Cystic Fibrosis; Fibrosis
Study type: Interventional
Phase: Phase 2

Summary: 
      This study will measure the inflammatory effects of digitoxin on IL-8 and neutrophil counts
      in induced sputum in stable Cystic Fibrosis (CF) patients and the pharmacokinetics of
      digitoxin in serum.

      Funding Source-FDA OOPD
    

Detailed description: 
      The study will be conducted as a randomized, double blind, placebo-controlled, repeat dosing
      trial evaluating the effects of 28 days of digitoxin on IL-8 and neutrophil concentrations in
      induced sputum in subjects with mild to moderate cystic fibrosis lung disease. Twenty-four
      total patients will be randomized into 3 groups of 8 subjects each (0.05 mg or 0.1 mg
      digitoxin or a placebo).
    

Intervention name(s): digitoxin; digitoxin; placebo
Intervention type(s): Drug; Drug; Other
Intervention description(s): 0.05mg tabs, once daily for 28 days; 0.1mg pills, once daily for 28 days.; pill taken once daily for 28 days
Intervention MeSH terms: Digitoxin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: digitoxin; inflammatory markers; cytokines; gene expression
Comparative Bioavailability Study of Clarithromycin 500 mg Tablets in Fed State
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The objective of this study was to investigate the bioequivalence of Genpharm's
      clarithromycin tablets following a single, oral 500 mg (1 x 500 mg) dose compared to the
      Biaxin® filmtab® (Abbott Laboratories USA) administered under fed conditions. Forty-four (44)
      healthy, light-, non- or ex-smoking subjects of at least 18 a years of age were randomized,
      in this two-period, two-treatment crossover bioequivalence study conducted by Eric Sicard,
      M.D. at Algorithme Pharma Inc. Montreal, Canada.

      Statistical analysis of the data reveals that 90% confidence intervals are within the
      acceptable bioequivalent range of 80% and 125% for the natural log transformed parameters
      AUCT, AUCI and Cmax. This study demonstrates that Genpharm's clarithromycin 500 mg tablets
      are bioequivalent to Biaxin® filmtab® 500 mg tablets (Abbott Laboratories USA) administered
      under fed conditions.
    


Intervention name(s): Clarithromycin; Clarithromycin
Intervention type(s): Drug; Drug
Intervention description(s): Single-dose 500 mg immediate-release oral tablet; single-dose 500 mg immediate-release oral dose'
Other intervention name(s): Biaxin® , Biaxin® Filmtabs
Intervention MeSH terms: Clarithromycin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Study of NGX-4010 for the Treatment of Postherpetic Neuralgia
Condition: Peripheral Nervous System Diseases; Pain; Neuralgia; Herpes Zoster; Shingles
MeSH terms: Herpes Zoster; Neuralgia; Nervous System Diseases; Neuralgia, Postherpetic; Peripheral Nervous System Diseases
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of the study is to assess the efficacy and safety of NGX-4010 applied for 60
      minutes for the treatment of postherpetic neuralgia (PHN).
    

Detailed description: 
      This study is a 12-week randomized, double-blind, controlled multi-center evaluation of the
      efficacy, safety and tolerability of NGX-4010 for the treatment of PHN. Eligible subjects
      will have moderate to severe pain from PHN, with average NPRS scores during screening of 3 to
      9 (inclusive). Painful areas of up to 1000 square centimeters will be treated during a single
      treatment administration in this study. Subjects will be randomly assigned to receive active
      NGX-4010 patches or low-concentration control patches that are identical in appearance,
      according to a 1:1 allocation scheme.

      Subjects may be on stable chronic oral pain medication regimens, but currently will not be
      using any topical pain medications on the affected areas. NPRS scores for the average pain in
      the past 24 hours will be recorded daily in the evening, beginning on the day of the
      Screening Visit (usually on Day -14). Subjects will continue to record NPRS scores in a
      take-home diary from the evening on the day of treatment through the evening before the
      Termination Visit at Week 12. Subjects will return for interim follow-up visits at Weeks 4
      and 8 following study treatment.
    

Intervention name(s): NGX-4010
Intervention type(s): Drug
Intervention MeSH terms: Capsaicin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: dermal assessment; pain measurement; diary; PHN; shingles; neuropathy; analgesics; capsaicin; postherpetic neuralgia
Calcium Dobesilate Versus Coasting for Prevention of Ovarian Hyperstimulation Syndrome
Condition: Infertility
MeSH terms: Infertility; Ovarian Hyperstimulation Syndrome
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The purpose of this study is to compare the effect of oral Calcium Dobesilate versus costing
      in the prevention of ovarian hyperstimulation syndrome (OHSS) in high-risk women underwent
      intracytoplasmic sperm injection (ICSI).
    

Detailed description: 
      Two hundred and twenty women at risk of ovarian hyperstimulation syndrome during ICSI cycles
      will be randomly scheduled into two equal groups. In group A, (Calcium Dobesilate group), 1
      cap / 8 hs Doxium ( 500mg) will be given at day of HCG injection and for 3 weeks ; while in
      group B (Coasting group), coasting (withholding gonadotrophins while maintaining pituitary
      suppression) follow up every day by measuring E2 for 3 days then either giving triggering or
      cycle cancellation is done
    

Intervention name(s): Calcium Dobesilate; coasting
Intervention type(s): Drug; Other
Intervention description(s): 1 cap / 8 hs Calcium Dobesilate ( 500mg) will be given at day of HCG injection and for 21 days; In group B, coasting (withholding gonadotrophins while maintaining pituitary suppression) for 3 days then either giving triggering or cycle cancellation is done
Other intervention name(s): doxium
Intervention MeSH terms: Calcium Dobesilate; Calcium
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention
A Study in Opioid-Experienced, Non-Dependent Recreational Drug Users to Determine the Abuse Potential and Safety of CL-108 Tablets Administered Via the Oral Route
Condition: Pain; Nausea; Vomiting
MeSH terms: Nausea; Vomiting
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess the abuse potential of CL-108 tablets, including the
      abuse deterrent effects of promethazine, following oral administration, relative to
      hydrocodone/acetaminophen (APAP) tablets and placebo in non-dependent, recreational opioid
      users.
    

Detailed description: 
      The purpose of this study is to assess the abuse potential of CL-108 tablets, including the
      abuse deterrent effects of promethazine, following oral administration, relative to
      hydrocodone/acetaminophen (APAP) tablets and placebo in non-dependent, recreational opioid
      users; to assess the cognitive and behavioral effects of CL-108 tablets following oral
      administration relative to hydrocodone/APAP tablets and placebo in non-dependent,
      recreational opioid users; and to assess the safety of orally administered CL-108 tablets
      relative to hydrocodone/APAP tablets and placebo in non-dependent, recreational opioid users.
    

Intervention name(s): CL-108; M366; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 7.5 mg/325 mg/12.5 mg tablet; 7.5 mg/325 mg tablet
Other intervention name(s): Low-dose CL-108 and High-dose CL-108; Low-dose M366 and High-dose M366; 0 mg tablet
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: Pain; Nausea; Vomiting
Efficacy of Erenumab in Chronic Cluster Headache
Condition: Cluster Headache; Trigeminal Autonomic Cephalalgias; Headache Disorders, Primary; Brain Disease
MeSH terms: Brain Diseases; Cluster Headache; Headache Disorders; Headache Disorders, Primary; Trigeminal Autonomic Cephalalgias; Headache
Study type: Interventional
Phase: Phase 2

Summary: 
      The main purpose of this study is to evaluate the efficacy of erenumab in participants with
      chronic cluster headache.
    

Detailed description: 
      The purpose of this study is to determine the efficacy of erenumab in a loading dose of 280mg
      followed by 140mg after 4 weeks compared to placebo as a prophylactic treatment in patients
      with chronic cluster headache.

      This study has a 10-week 2-arm, randomized, double-blind, parallel- group, placebo-controlled
      design. Data from this study will provide important information if the blockade of the CGRP
      receptor with erenumab is an efficacious principle for the treatment of chronic cluster
      headache
    

Intervention name(s): Erenumab; Placebo
Intervention type(s): Biological; Drug
Intervention description(s): Pre-filled syringe; s.c. injection; Pre-filled syring; s.c. injection
Other intervention name(s): AMG 334
Intervention MeSH terms: Erenumab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: Pain; Neurology
A Study of TDM-105795 in Male Subjects With Androgenetic Alopecia (AGA)
Condition: Alopecia, Androgenetic
MeSH terms: Alopecia; Alopecia Areata
Study type: Interventional
Phase: Phase 1

Summary: 
      Multi-center, randomized, double-blind, vehicle-controlled, parallel group, multi-dose
      escalation study of TDM-105795 in male subjects, 18 to 55 years old, with Androgenetic
      Alopecia (AGA).
    

Detailed description: 
      Protocol 239-11651-102 is a planned Phase 1 study entitled "A Randomized, Double-Blind,
      Vehicle-Controlled, Parallel Group, Multi-Dose Escalation Study to Evaluate the Safety,
      Tolerability, and Pharmacokinetics of TDM-105795 in Healthy Male Subjects with Androgenetic
      Alopecia". Eligible subjects will be assigned to a sequential treatment cohort and will
      receive either one of the TDM-105795 solutions or the Placebo. The assigned test article will
      be applied once daily onto the scalp in the hair loss area (e.g., top of head and temple
      areas). All subjects will be treated with 1 mL/dose of test article with application to the
      scalp focusing on the regions that are bald and thinning.
    

Intervention name(s): TDM-105795; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): TDM-105795 topical solution; Placebo for TDM-105795 topical solution
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: A Randomized, Double-Blind, Vehicle-Controlled, Parallel Group, Multi-Dose Escalation Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of TDM-105795 in Healthy Male Subjects with Androgenetic Alopecia
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Explorative Trial Evaluating the Efficacy and Tolerability of LEO43204 in Moderate to Severe Acne
Condition: Acne Vulgaris
MeSH terms: Acne Vulgaris
Study type: Interventional
Phase: Phase 2

Summary: 
      An exploratory Phase 2, single, centre, prospective, randomized, placebo-controlled,
      double-blinded, split-pace (left/right) design trial to evaluate the efficacy and
      tolerability of LEO 43204 in adults with moderate to severe acne.
    


Intervention name(s): LEO43204; Placebo
Intervention type(s): Drug; Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Optimal Level of PEEP in Protective One-lung Ventilation
Condition: Video-assisted Thoracic Surgery; Postoperative Atelectasis; Positive End-expiratory Pressure
MeSH terms: Pulmonary Atelectasis
Study type: Interventional

Summary: 
      Protective ventilation strategy has been widely applied in the field of thoracic surgery
      requiring one-lung ventilation to reduce postoperative pulmonary complications. Low tidal
      volume, positive end-expiratory pressure (PEEP), and intermittent recruitment maneuver are
      key components of protective ventilation strategy. Recent evidence suggests that a tidal
      volume of 4-5 ml/kg should be applied during protective one-lung ventilation. However,
      optimal level of PEEP is still unclear. This study aims to investigate optimal level of PEEP
      to minimize postoperative atelectasis by comparing modified lung ultrasound score in patients
      applied protective one-lung ventilation using PEEP of 3, 6, or 9 cm of water during thoracic
      surgery.
    


Intervention name(s): PEEP 3 cm of water; PEEP 6 cm of water; PEEP 9 cm of water
Intervention type(s): Procedure; Procedure; Procedure
Intervention description(s): PEEP of 3 cm of water will be applied during one-lung ventilation.; PEEP of 6 cm of water will be applied during one-lung ventilation.; PEEP of 9 cm of water will be applied during one-lung ventilation.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Protective ventilation; One-lung ventilation
A Trial to Evaluate the Pharmacokinetic and Pharmacodynamic Properties of BioChaperone® Insulin Lispro, Fiasp® and NovoRapid® Delivered by an Insulin Pump
Condition: Type1 Diabetes Mellitus
MeSH terms: Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a single-centre, randomised, double-blind, three-period, complete cross-over trial
      comparing the pharmacokinetic and the pharmacodynamic properties of BioChaperone® insulin
      lispro and the two active comparators Fiasp® and Novorapid® when given as a bolus on top of
      basal delivery with an insulin pump in subjects with type 1 diabetes mellitus. Each subject
      will be randomly assigned to a treatment sequence consisting of 3 dosing visits during which
      the subject will receive the investigational products. In a euglycaemic clamp setting,
      subjects will be given a bolus dose of 0.15 U/kg body weight.

      Throughout the glucose clamp procedure, blood glucose will be stabilised at a target level of
      100 mg/dL by means of an intravenous infusion of glucose. Blood samples for pharmacokinetic
      assessment will be drawn at specified timepoints and glucose infusion rates and blood glucose
      concentrations will be recorded for pharmacodynamic assessment during the 10-hour clamp
      procedure after dosing.
    


Intervention name(s): BioChaperone® insulin lispro; Fiasp®; Novorapid®
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Single subcutaneous administration of a bolus of 0.15 U/kg body with a pump; Single subcutaneous administration of a bolus of 0.15 U/kg body with a pump; Single subcutaneous administration of a bolus of 0.15 U/kg body with a pump
Intervention MeSH terms: Insulin Lispro; Insulin Aspart
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
he Effect of Motivational Statements Applied to Nurses in the Emergency Department on Job Satisfaction, Compassion Fatigue and Communication Skills During the Pandemic Period: A Randomized Controlled Study
Condition: Satisfaction; Compassion Fatigue; Communication, Social
MeSH terms: Emergencies; Fatigue; Compassion Fatigue
Study type: Interventional

Summary: 
      Aim and objectives: The aim of this study is to examine the effect of motivational
      notifications applied to emergency nurses on job satisfaction, compassion fatigue and
      communication skills during the COVID-19 pandemic.

      Background: Emergency room nurses working on the front lines during the COVID-19 pandemic;
      many factors such as excessive workload, prolonged working hours, threat of infection, death
      of the patients they care for have caused them to experience physical, social and
      psychological problems.

      Design: It is a randomized controlled, open-label study. Methods: This study was carried out
      with a total of 60 nurses working in the emergency units of two training and research
      hospitals in Istanbul. Participants were divided into motivational group and control group.
      Motivational notifications were sent via Short Message Service (SMS) to the mobile phones of
      the participants in the motivational group (n=30) for 21 days. No motivational notification
      was sent to the control group (n=30) during this process. Data were obtained with the
      Individual Introduction Form, Job Satisfaction, Compassion Fatigue and Communication Skills
      Scale.
    


Intervention name(s): Motivation
Intervention type(s): Other
Intervention description(s): Motivational notifications were sent via SMS message to the nurses in the motivation group (n=30) at 07.00, 12.00 and 16.00 for 21 days.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention