bioihbjkbjnl/mcl2 huggingface dataset:
CGRP's Cluster Headache Inducing Abilities in Cluster Headache Patients
Condition: Cluster Headache
MeSH terms: Cluster Headache; Headache
Study type: Interventional

Summary: 
      It has previously been shown that nitroglycerine induces cluster headache attacks in episodic
      cluster headache patients (ECH patients) in bouts but not in remission phase. Furthermore,
      plasma concentrations of calcitonin gene-related peptide (CGRP) have been shown to be
      significantly higher during, but not before and after, an attack.

      The attack appears around 20-40 min after nitroglycerine infusion with vasodilatation. During
      this latency period preceding the attack, no increase in CGRP plasma concentrations is seen.
      CGRP induces migraine attacks in 65% of migraine patients, and CGRP antagonists as well as
      monoclonal antibodies against CGRP are effective in migraine treatment.

      Based on the above the investigators hypothesize the following:

        1. Provoking ECH patients in bout with CGRP triggers cluster headache attacks

        2. Provoking ECH patients in remission with CGRP does not trigger cluster headache attacks

        3. Provoking chronic cluster headache patients with CGRP triggers cluster headache attacks
           more often than in ECH patients.
    


Intervention name(s): Calcitonin-Gene Related Peptide; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 1,5 µg/min of IV CGRP over 20 mins; 40 ml of normal saline over 20 mins
Other intervention name(s): CGRP; Normal saline
Intervention MeSH terms: Calcitonin; Salmon calcitonin; Calcitonin Gene-Related Peptide; Katacalcin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Employment-Based Depot Naltrexone Clinical Trial
Condition: Opiate Dependence
MeSH terms: Opioid-Related Disorders
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine whether employment-based naltrexone treatment
      proves effective in promoting depot naltrexone adherence and drug abstinence.
    

Detailed description: 
      A randomized study is planned over 5 years to evaluate the effectiveness of the Therapeutic
      Workplace in promoting naltrexone adherence in opiate-dependent adults. An extended-release
      depot formulation of naltrexone will be used. Participants will be offered an inpatient
      opioid detoxification and naltrexone induction. Participants who complete the oral naltrexone
      induction will be randomly assigned to one of two groups. Both groups will be invited to work
      in the Therapeutic Workplace and will be prescribed depot naltrexone for 6 months. Patients
      in the "Work Plus Naltrexone Contingency" condition will earn access to working and earning
      salary by taking depot naltrexone once per month. "Work Plus Naltrexone Prescription"
      participants will be encouraged to take depot naltrexone monthly, but access to working and
      earning salary will not be contingent on doing so.
    

Intervention name(s): employment-based reinforcement
Intervention type(s): Combination Product
Intervention description(s): Participants in the "Work Plus Naltrexone Contingency" condition were required to take scheduled doses of depot naltrexone to work and earn wages.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: opiate dependence; naltrexone; reinforcement; behavior therapy; cocaine dependence; risk reduction behavior
Brief Strategic Family Therapy for Adolescent Drug Abusers
Condition: Substance Abuse
MeSH terms: Substance-Related Disorders
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to compare Brief Strategic Family Therapy (BSFT) for Adolescent
      Drug Abusers to treatment as usual (TAU).

      An additional follow up assessment, funded by an American Recovery & Reinvestment Act (ARRA)
      grant, was completed 5 years post randomization in order to examine the long term effects of
      outpatient treatments for illicit drug using adolescents.
    

Detailed description: 
      Adolescent drug abuse continues to be one of the most pressing public health issues in the
      United States-our nation's teenagers continue to use illicit drugs at a worrisome rate. Broad
      reviews of the treatment outcome literature indicate that family interventions in general,
      and Brief Strategic Family Therapy (BSFT) in particular, are effective with drug using youth.
      This study is designed to compare BSFT to treatment as usual (TAU). The researchers believe
      that BSFT will be much more effective than TAU in reducing adolescent drug use. They will
      also examine which of these treatment approaches does a better job of engaging adolescents
      and family members in treatment, decreasing problem behaviors, decreasing sexually risky
      behaviors, increasing pro-social activities (e.g., school, work), and improving the
      functioning of the family.

      With the addition of the extended follow up, we have the opportunity to examine the
      sustainability of study outcomes into early adulthood, filling a gap in the treatment
      research literature about the long-term effects of adolescent substance abuse treatment. The
      follow up study examined the long term effectiveness of BSFT compared to TAU in the rates of
      substance use, number of arrests and externalizing behaviors, in youth who received study
      treatments at the time when they were adolescents.
    

Intervention name(s): Brief Strategic Family Therapy (BSFT); Treatment as Usual
Intervention type(s): Behavioral; Behavioral
Intervention description(s): BSFT is a family therapy approach that consists of 12 to 16 sessions (each 1 to 1.5 hours long) over a 4-month period during the Main Study, and up to 8 "booster" sessions. Interventions are delivered to adolescents and relevant family members in non-restrictive community settings (e.g., clinics, homes, school).; TAU varies depending on site, however each will offer services that include at least 1 therapy session (individual or group therapy) per week during the Main Study, as well as participation in ancillary services (e.g., case management, self help groups, etc.) over a four month period.
Other intervention name(s): BSFT; TAU
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: BSFT; Family Therapy; Adolescents; Substance Abuse
Open Label Study Assessing Effectiveness Of Amlodipine/Atorvastatin In Subjects With Hypertension and Dyslipidaemia
Condition: Hypertension; Dyslipidemia
MeSH terms: Hypertension; Dyslipidemias
Study type: Interventional
Phase: Phase 3

Summary: 
      To evaluate the effectiveness of amlodipine/atorvastatin therapy by assessing the percentage
      of subjects who reach target blood pressure (BP) and LDL-C targets as defined by their
      governing guidelines.
    


Intervention name(s): Amlodipine/Atorvastatin
Intervention type(s): Drug
Intervention MeSH terms: Amlodipine; Amlodipine, atorvastatin drug combination; Atorvastatin
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Identifying Electrophysiological Targets for Transcranial Magnetic Stimulation in Cocaine Use Disorder (Pilot Study)
Condition: Cocaine Use Disorder
Study type: Interventional

Summary: 
      The purpose of this study is to assess the effects of active intermittent theta burst
      stimulation (iTBS) to dorsomedial prefrontal cortex (dmPFC) on electroencephalogram (EEG)
      measures of reward sensitivity and cue reactivity and cocaine craving in cocaine users
    


Intervention name(s): iTBS to dmPFC; Sham iTBS
Intervention type(s): Device; Device
Intervention description(s): TMS will be delivered with a MagVenture Mag Pro R30 with the Cool-B70 A/P coil with active liquid cooling and active/sham sides. Approximately 25% of the nasion-inion distance, or Talairah coordinates X 0 Y+60 Z+60 will be measured.The first session will begin with the acquisition of the resting motor threshold (rMT; lowest stimulus intensity that elicits a visible twitch on 50% of the trials) on the contralateral hand. iTBS (triplet 50 Hz bursts, repeated at 5 Hz, 2 sec on and 8 sec off; 600 pulses per session) will be delivered at 110% of the rMT and will last about 3 minutes. Each participant will receive 2 sessions with a 15-20 minute interval between sessions.; Sham TMS will be delivered with the sham side of the MagVenture Cool B70 A/P coil. The software will be pre-programmed by a staff member that will not be involved in data analysis or collection for blinding purposes. The sham stimulation will match the number of pulses and length of time as the active condition and each participant will receive 2 sessions with a 15-20 min interval between sessions.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Basic Science
Keywords: Transcranial Magnetic Stimulation (TMS)
Study to Investigate if the Uptake of Ticagrelor Into the Body Differs Depending on Method of Administration.
Condition: Bioavailability Heathy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      Study to investigate if the uptake of Ticagrelor into the body differs depending on method of
      administration.
    

Detailed description: 
      Study to evaluate the bioavailability of the crushed ticagrelor tablets when administered
      orally or through nasogastric tubes compared to whole ticagrelor tablets given orally
    

Intervention name(s): Ticagrelor 90 mg whole tablet; Ticagrelor 90 mg tablet crushed; Dispersed ticagrelor 90 mg tablet suspended in water - nasogastric tube
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Ticagrelor 90 mg whole tablet administered as a single oral dose; Ticagrelor 90 mg crushed and suspended in water; Dispersed 90 mg ticagrelor 90 mg tablet suspended in water and administered through a nasogastric tube into the stomach
Intervention MeSH terms: Ticagrelor
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Phase 1, pharmacokinetic, safety, Ticagrelor
Nasal Gel for the Prevention and Treatment of Nausea Associated With Motion Sickness
Condition: Motion Sickness
MeSH terms: Motion Sickness
Study type: Interventional
Phase: Phase 3

Summary: 
      Phase 3 clinical trial is a randomized, double-blind, placebo-controlled study to identify
      the safety, efficacy and pharmacokinetics of a repeated-dose regimen of DPI 386 nasal gel
      (intranasal scopolamine gel) for the prevention and treatment of nausea associated with
      motion sickness.
    

Detailed description: 
      This Phase 3 clinical trial is a randomized, double-blind, placebo-controlled study to
      identify the safety, efficacy and pharmacokinetics of a repeated-dose regimen of DPI 386
      nasal gel (intranasal scopolamine gel) for the prevention and treatment of nausea associated
      with motion sickness. The study will have three arms: DPI-386 nasal gel, placebo nasal gel,
      and TDS patch (1.5 mg/72 hours), the current standard of care for the treatment of motion
      sickness. The study will include 34 subjects per arm, for a total of 102 subjects (n=102). A
      double dummy design will be used to mask the treatment assignment. All subjects will receive
      both a patch and nasal gel randomized to one of the following three arms: DPI-386 Nasal Gel +
      placebo patch, placebo nasal gel + placebo patch, or placebo nasal gel + TDS patch.

      Treatment Day 1 will be conducted aboard an ocean-going vessel to obtain data in an
      operationally relevant real world environment immediately followed by Treatment Days 2 and 3
      at a clinical site or one of its two satellite locations.
    

Intervention name(s): DPI-386 Nasal Gel; Placebos
Intervention type(s): Drug; Drug
Intervention description(s): 1.5 mg reservoir of scopolamine to be delivered over a 72-hour period; Placebo Nasal Gel and placebo patch
Other intervention name(s): Transderm Scop®
Intervention MeSH terms: Scopolamine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
The Use of Daclizumab and Anti-Thymocyte Globulin in Lung Transplantation
Condition: Patients Active and Listed for Lung Transplantation
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The purpose of this study is to compare outcomes in patients undergoing lung transplantation,
      using 2 different induction therapies. Primary outcome is survival and secondary outcomes
      include freedom from infection and freedom from rejection.
    

Detailed description: 
      Acute and chronic allograft rejection are two of the common problems limiting and
      complicating the utility of lung transplantation. The timing and frequency of acute rejection
      has been shown to be a significant risk factor for the development of chronic allograft
      rejection. As an adjunct to standard triple immunosuppressive therapy, induction therapy is
      thought to decrease the incidence of acute rejection.Daclizumab is an interleukin 2 receptor
      (IL-2) antagonist which is FDA approved as an immunosuppressive agent. Thymoglobulin is an
      anti-lymphocyte immunosuppressive agent that has been shown in other solid organ transplant
      studies to be successful in delaying the first episode of rejection but has not decreased the
      incidence of Obliterative Bronchiloitis (chronic rejection)in lung transplantation.
    

Intervention name(s): Zenapax
Intervention type(s): Drug
Intervention MeSH terms: Daclizumab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Induciton therapy, Daclizumab, Thymoglobulin, lung transplantation
Evaluation of Safety, Tolerability, Pharmacokinetics, Drug-Drug and Food Interactions of Single and Multiple Doses of S-648414 in Healthy Adults
Condition: Healthy Volunteer
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective of Part 1 of the study is to evaluate the safety and tolerability of
      S-648414 after administration of a single oral dose of S-648414 in healthy adult study
      participants.

      The primary objective of Part 2 is to evaluate the safety and tolerability of S-648414 after
      administration of multiple oral doses of S-648414 in healthy adult study participants.

      The primary objectives of Part 3 are evaluate the safety and tolerability of S-648414 after
      administration of multiple oral doses of S-648414 in healthy adult study participants, and to
      evaluate the effect of S-648414 on the pharmacokinetics (PK) of dolutegravir and the effect
      of dolutegravir on the PK of S-648414 in healthy adult study participants.
    

Detailed description: 
      Amendment 2 of the study Protocol added a third part (Part 3) to the study. The revised
      Official Title for the Protocol is:

      "A Phase 1, Randomized, Double-Blind, Single-Ascending-Dose, and Food Effect Study to Assess
      the Safety, Tolerability, Ventricular Repolarization, and Pharmacokinetics of S-648414 in
      Healthy Adult Study Participants (Part 1); A Phase 1, Randomized, Double-Blind,
      Multiple-Ascending-Dose Study to Assess the Safety, Tolerability, and Pharmacokinetics of
      S-648414 and A Drug-Drug Interaction Study with the CYP3A Substrate, Midazolam, in Healthy
      Adult Study Participants (Part 2); and A Phase 1 Open-Label Study to Assess the Effect of
      S-648414 on the Pharmacokinetics of Dolutegravir and the Effect of Dolutegravir on the
      Pharmacokinetics of S-648414 in Healthy Adult Study Participants (Part 3)"
    

Intervention name(s): S-648414; Placebo; Midazolam; Dolutegravir
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Tablet for oral administration; Tablet for oral administration; Solution for oral administration; Tablet for oral administration
Other intervention name(s): Versed; TIVICAY
Intervention MeSH terms: Dolutegravir; Midazolam
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Pharmacokinetics; S-648414; Food effect; Antiretroviral; Drug-drug interaction
Intralipid for Repeated Implantation Failure
Condition: Infertility
MeSH terms: Infertility
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      Intralipid infusion can improve outcome in women with recurrent Intracytoplasmic sperm
      injection ( ICSI) failure due to elevated TH1 cytokine response.
    

Detailed description: 
      Infertile patients undergoing Intracytoplasmic Sperm Injection (ICSI) cycle with history of
      repeated implantation failure, intralipid will be given to the intervention group.

      The primary outcome measure is the clinical pregnancy rate, secondary outcome measures
      implantation rate, ongoing pregnancy rate, abortion rate.
    

Intervention name(s): intralipid; Saline
Intervention type(s): Drug; Drug
Intervention description(s): IV infusion of intralipid 20% between day4 and 9 of ovarian stimulation & another dose when got pregnant within the 1st week of positive pregnancy test; Saline 0.9% IV infusion between day4 and 9 of ovarian stimulation & another dose when got pregnant within the 1st week of positive pregnancy test
Other intervention name(s): intralipid 20%; Saline 0.9%
Intervention MeSH terms: Soybean oil, phospholipid emulsion
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: repeated implantation failure; intralipid
Comparative Trial in Hormone Withdrawal Associated Symptoms
Condition: Oral Contraceptive
Study type: Interventional
Phase: Phase 3

Summary: 
      This clinical research study will examine whether an oral contraceptive pill taken with a
      monthly hormone-free interval of 4 days reduces hormone withdrawal associated symptoms
      compared to an oral contraceptive pill taken with a monthly hormone-free interval of 7 days
      after 4 cycles of treatment.
    


Intervention name(s): EE20/DRSP (YAZ, BAY86-5300); Ethinylestradiol (EE) and desogestrel (DSG) (Mercilon)
Intervention type(s): Drug; Drug
Intervention description(s): 4 cycles of treatment / per cycle: 1 tablet (EE 0.02 mg / DRSP 3 mg) daily for 24 days followed by 1 placebo tablet daily for 4 days; 4 cycles of treatment / per cycle: 1 tablet (EE 0.02 mg / DSG 0.15 mg) daily for 21 days followed by 1 placebo tablet daily for 7 days
Intervention MeSH terms: Ethinyl Estradiol; Desogestrel
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: hormone withdrawal associated symptoms
Occipital Nerve Stimulation in Fibromyalgia
Condition: Fibromyalgia
MeSH terms: Fibromyalgia; Myofascial Pain Syndromes
Study type: Interventional
Phase: Phase 2

Summary: 
      The aim of this study is to investigate whether greater occipital nerve stimulation is
      effective in the treatment of fibromyalgia related pain. The study uses sub sensory threshold
      stimulation and placebo stimulation in order to investigate whether sub-threshold stimulation
      is feasible in a placebo controlled study.
    


Intervention name(s): Occipital nerve stimulation
Intervention type(s): Device
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Photopill Treatment in Healthy Volunteers
Condition: Ulcerated Mucosa of Colon
MeSH terms: Ulcer
Study type: Interventional
Phase: Phase 1

Summary: 
      Photo-bio-stimulation by Low Level Light therapy(LLLT) has demonstrated its clinical use in
      chemotherapy/radiotherapy oral mucositis.

      Unpublished study (Melzer, Ben-Yehuda et al. UEGW 2012) with the Photopill (LLLT) capsule
      treatment in mice showed a significant beneficial effect on the endoscopic severity of
      DSS-induced colitis in mice.

      Therefore a phase 1 trial is designed to assess the safety and feasibility of the Photopill
      treatment in healthy volunteers.
    


Intervention name(s): Photopill treatment
Intervention type(s): Device
Intervention description(s): 2 courses of 5 Photopill treatments within 14 days. In each treatment, 3cm of rectal tissue will be exposed, 2 minutes per cm, to low level light therapy.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Study in Ankylosing Spondylitis (AS) and Psoriatic Arthritis (PsA) Patients to Evaluate Work Productivity Before and After the Start of Adalimumab Therapy in Daily Practice in Belgium
Condition: Ankylosing Spondylitis; Psoriatic Arthritis
MeSH terms: Spondylitis; Arthritis; Arthritis, Psoriatic; Spondylarthritis; Spondylitis, Ankylosing
Study type: Observational

Summary: 
      This observational study will document to what extent in daily clinical practice the work
      productivity is affected before and after the start of adalimumab treatment.

      Changes in the employment status and work productivity of participants with AS and PsA before
      and after the start of adalimumab will be noted. The relationship between employment status,
      work productivity, disease activity and clinical evaluations will be evaluated. Since AS and
      PsA might be diseases with a strong impact on the daily life of the participant, an
      evaluation will be performed to the effect of the disease on quality of life and work
      productivity.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Participants with AS and PsA followed in university or peripheral hospitals or peripheral
        private practices with experience in AS and PsA care.
      
Keywords: work productivity; multicenter study