bioihbjkbjnl/mcl2 huggingface dataset:
Investigation of Kinetic Oscillation Stimulation by the Chordate System S101 in the Treatment of Non Allergic Rhinitis
Condition: Nasal Congestion; Non-allergic Rhinitis
MeSH terms: Rhinitis; Common Cold
Study type: Interventional

Summary: 
      This is an interventional, multicenter, double-blind, placebo-controlled trial in which
      patients diagnosed with non-allergic rhinitis will be randomized to either intranasal
      stimulation, or placebo treatment with the Chordate System at two occasions.
    

Detailed description: 
      This is a double-blind, placebo-controlled, multi-center study in which patients diagnosed
      with non-allergic rhinitis will receive intranasal stimulation with the Chordate System at
      two occasions. Objectives are to evaluate the efficacy of the procedure in reducing disease
      specific symptoms such as nasal congestion, rhinorrhea, nasal itching and sneezing, but also
      to investigate the influence on quality of life, safety and tolerability.
    

Intervention name(s): Chordate S101; Chordate S101 Placebo
Intervention type(s): Device; Device
Intervention description(s): Active treatment: The controller creates air-mediated kinetic oscillations with regulated pressure and frequency during a preset treatment time; Placebo treatment: Placebo treatment is similar to active treatment, but with no oscillations. It is difficult to discern any difference between active and placebo treatment.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Evaluation of the Effectiveness of Ischemic Pre-conditioning on the Morbidity and Mortality of Open Surgery of Thoracoabdominal Aortic Aneurysms.
Condition: Aortic Aneurysm; Surgery
MeSH terms: Aneurysm; Aortic Aneurysm; Aortic Aneurysm, Thoracoabdominal
Study type: Interventional

Summary: 
      Patients having a planned open surgery of thoracoabdominal aortic aneurysms and enrolled in
      the study will be randomized the day of the surgery in 2 groups:

        -  Arm 1 : Patients with aortic clamping with pre-conditioning

        -  Arm 2 : Patients with aortic clamping without pre-conditioning Patients will be then
           followed, during 60 days after surgery.
    


Intervention name(s): clamping with pre-conditioning (PCl)
Intervention type(s): Procedure
Intervention description(s): PCI procedure: clamping of the supracellular thoracic aorta for 5 minutes followed by a 5-minutes de-clamping period.
PCI procedure is repeated twice.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Clamping; pre-conditioning
Effects of Carvedilol on Cocaine Use in Humans - 11
Condition: Cocaine-Related Disorders
MeSH terms: Cocaine-Related Disorders
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to examine carvedilol effects in response to cocaine.
    

Detailed description: 
      The purpose of this study was to determine whether carvedilol, and alpha and beta adrenergic
      blocker, would inhibit the priming effect of cocaine in a laboratory model. A total of 12
      subjects were enrolled in this double blind, placebo controlled, outpatient study. After an
      adaptation session, three experimental sessions were held, 2-9 days apart. On each of 3
      experimental sessions, a single oral dose of low (25mg) or high dose of carvedilol (50mg) or
      placebo were administered. Two hours following carvedilol or placebo treatment, subjects
      received a priming dose of smoked cocaine, 0.4 mg/kg. during the second part of the session,
      subjects had the option to earn up to 2 tokens by working on a computer task that could later
      be exchanged for money or deliveries of cocaine. We proposed that blockage of adrenergic
      receptors by carvedilol would significantly alter the subjective and physiological effects of
      cocaine.
    

Intervention name(s): Carvedilol
Intervention type(s): Drug
Intervention MeSH terms: Carvedilol
Masking: Double
Primary purpose: Treatment
Phase II Study of Pandemic Influenza Vaccine
Condition: Influenza
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 2

Summary: 
      The World Health Organisation has warned that an influenza pandemic is inevitable. The avian
      influenza H5N1 virus strain is the leading candidate to cause the next influenza pandemic.
      This study will test the safety and immunogenicity of a H5N1 Pandemic Influenza Vaccine in
      healthy adults. The Study will also assess Lot to Lot consistency of the Pandemic Influenza
      Vaccine.
    


Intervention name(s): Pandemic Influenza Vaccine
Intervention type(s): Biological
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Prevention
Keywords: Pandemic; Influenza; Prevention; Vaccine; Prevention of Pandemic Influenza
Effect of Fluconazole, Clarithromycin, and Rifabutin on the Pharmacokinetics of Sulfamethoxazole-Trimethoprim and Dapsone and Their Hydroxylamine Metabolites
Condition: Bacterial Infections; Mycoses; HIV Infections
MeSH terms: Infections; Communicable Diseases; Mycoses; Bacterial Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      To determine the effects of fluconazole and either rifabutin or clarithromycin, alone and in
      combination, on the pharmacokinetics of first sulfamethoxazole-trimethoprim and then dapsone
      in HIV-infected patients.

      Although prophylaxis for more than one opportunistic infection is emerging as a common
      clinical practice in patients with advanced HIV disease, little is known about possible
      adverse drug interactions. The need exists to define pharmacokinetics and pharmacodynamic
      adverse interactions of the many combination prophylactic regimens that may be prescribed.
    

Detailed description: 
      Although prophylaxis for more than one opportunistic infection is emerging as a common
      clinical practice in patients with advanced HIV disease, little is known about possible
      adverse drug interactions. The need exists to define pharmacokinetics and pharmacodynamic
      adverse interactions of the many combination prophylactic regimens that may be prescribed.

      In Part A, patients receive sulfamethoxazole-trimethoprim (SMX/TMP) alone for 2 weeks, then
      in combination with fluconazole, rifabutin, or both drugs, each over 2-week periods in a
      randomly assigned order. Patients in Part B receive the same regimens except with
      clarithromycin substituted for rifabutin. In Part C, patients receive dapsone alone for 2
      weeks, then in combination with fluconazole, rifabutin, or both drugs in the same manner as
      in Part A. Part D patients receive the same regimen as those in Part C, except with
      clarithromycin substituted for rifabutin. Patients are followed every 2 weeks.
    

Intervention name(s): Clarithromycin; Rifabutin; Sulfamethoxazole-Trimethoprim; Dapsone; Fluconazole
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention MeSH terms: Clarithromycin; Dapsone; Rifabutin; Trimethoprim, Sulfamethoxazole Drug Combination; Fluconazole; Trimethoprim; Sulfamethoxazole
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Rifabutin; Trimethoprim-Sulfamethoxazole Combination; AIDS-Related Opportunistic Infections; Dapsone; Drug Interactions; Fluconazole; Acquired Immunodeficiency Syndrome; AIDS-Related Complex; Clarithromycin; Sulfamethoxazole-Trimethoprim
The Effect of Transcutaneous Posterior Tibial Nerve Stimulation in Patients With Fibromyalgia
Condition: Fibromyalgia
MeSH terms: Fibromyalgia; Myofascial Pain Syndromes
Study type: Interventional

Summary: 
      This study aimed to investigate the effectiveness of posterior tibial nerve stimulation
      (PTNS) in reducing pain, improving quality of life, and decreasing disease severity in
      patients with fibromyalgia.
    

Detailed description: 
      This prospective, single-blind, randomized controlled trial included female patients newly
      diagnosed with fibromyalgia who had started duloxetine treatment (30 mg/day). Patients who
      met the inclusion criteria and agreed to participate in the study were randomized (1:1) into
      two groups. Group 1 (PTNS+duloxetine) underwent six sessions of posterior tibial nerve
      stimulation, twice weekly, 3-4 days apart, in addition to duloxetine (30 mg/day). Group 2
      (duloxetine) received duloxetine only (30 mg/day). Randomization was performed manually, with
      assignments placed in opaque and sequentially numbered envelopes by off-site researchers who
      were not involved in patient care or follow-up. Outcome measures were assessed by two
      investigators who were blinded to each patient's group. The participants and nerve
      stimulators were not blinded to the group allocation. Patients were briefed to not disclose
      which group they were in during the assessment process.Patients in the study group received
      six sessions of posterior tibial nerve stimulation, twice weekly, 3-4 days apart, in addition
      to duloxetine; the controls received duloxetine only. The patients were evaluated three times
      (at baseline, 1st month, and 3rd month). Pain was evaluated using a numeric rating scale, the
      short-form McGill Pain Questionnaire, and quality of life with a 36-item Short-Form Health
      Survey (SF-36). Patient functional status and disease severity were evaluated using the
      fibromyalgia impact questionnaire (FIQ).
    

Intervention name(s): Transcutaneous Posterior Tibial Nerve Stimulation + Duloxetine 30 MG; Duloxetine 30 MG
Intervention type(s): Other; Drug
Intervention description(s): PTNS was applied using two 50 mm × 50 mm electrode pads per extremity. The live pad was placed superior to and medial to the medial malleolus. The ground pad was placed 5-10 cm proximal to the live pad. The PTNS was applied using biphasic square waves with a frequency of 10 Hz and pulse duration of 200 μs. The amplitude was adjusted to the level that produced painless paresthesia in each patient according to their tolerance. PTNS was applied for 30 minutes
Duloxetine 30 mg p.o 1X1 (daily); Duloxetine 30 mg p.o 1X1 (daily)
Intervention MeSH terms: Duloxetine Hydrochloride
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Other
Keywords: Chronic pain; Electric stimulation therapy; Fibromyalgia; Quality of life; Small fiber neuropathy
Single and Multiple Dose Evaluation of ABT-072 and to Evaluate the Effect of Food on the Pharmacokinetics of ABT-072
Condition: Hepatitis C
MeSH terms: Hepatitis C
Study type: Interventional
Phase: Phase 1

Summary: 
      To assess the safety, tolerability and pharmacokinetics of the ABT-072 tablet formulation
      administered as a single dose and then administered as multiple doses for 7 days. The effect
      of food on the safety, tolerability and pharmacokinetics of the ABT-072 tablet will also be
      evaluated.
    

Detailed description: 
      The study consists of two substudies. Substudy 1 is a two-period, single ascending dose (SAD)
      and multiple ascending dose (MAD) blinded, randomized, placebo-controlled, non-fasting study.
      Designated groups that participate in Period 1 (SAD) will also participate in Period 2 (MAD).
      Substudy 2 is an open-label, randomized two-period, crossover study to examine the effect of
      food on the pharmacokinetics of ABT 072.
    

Intervention name(s): ABT-072; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): See Arms information for a detailed description.; See Arms information for a detailed description.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Keywords: Phase 1; Single and Multiple Ascending Dose; Food Effect
Temozolomide in Treating Patients With Primary Brain Tumors or Metastatic Brain Tumors
Condition: Brain and Central Nervous System Tumors; Metastatic Cancer
MeSH terms: Nervous System Neoplasms; Central Nervous System Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      RATIONALE: Drugs used in chemotherapy, such as temozolomide, work in different ways to stop
      the growth of tumor cells, either by killing the cells or by stopping them from dividing.
      Collecting fluid samples through a catheter may help doctors find out how well temozolomide
      spreads throughout the brain.

      PURPOSE: This clinical trial is studying temozolomide in treating patients with primary brain
      tumors or metastatic brain tumors.
    

Detailed description: 
      OBJECTIVES:

        -  Determine the feasibility of microdialysis for assessing the intracerebral distribution
           of temozolomide in patients with primary or metastatic brain tumors.

        -  Determine the interstitial pharmacokinetics of temozolomide using an intracerebral
           microdialysis catheter in these patients.

        -  Determine the feasibility of assessing brain tumor metabolism using a microdialysis
           catheter to measure intracerebral levels of glucose, lactate, pyruvate, glutamate, and
           glycerol in these patients.

      OUTLINE: Patients are assessed for viable tumor during a debulking craniotomy or stereotactic
      biopsy. If viable tumor is confirmed, patients undergo placement of an intracerebral
      microdialysis (MD) catheter. The catheter, which is perfused continuously over 24 hours with
      artificial cerebrospinal fluid, is placed directly into the residual brain tumor or
      peritumoral brain tissue for neuropharmacokinetic studies of temozolomide. At least 25 hours
      but no more than 72 hours after placement of the catheter, patients receive a single dose of
      oral temozolomide. At the same time, intracerebral MD is initiated and serial samples of
      dialysate (i.e., brain extracellular fluid [ECF]) are collected periodically over 24 hours
      for analysis of intracerebral concentrations of temozolomide by liquid chromatography/tandem
      mass spectrometry. Serial blood samples for measuring plasma levels of temozolomide are also
      drawn and plasma temozolomide levels are compared with those in the brain ECF. Additional ECF
      samples are obtained to assess biochemical markers of brain tumor metabolism (i.e., glucose,
      lactate, pyruvate, glutamate, or glycerol) at least one hour before and 24 hours after
      administration of temozolomide.

      After completion of study therapy, patients are followed for up to 30 days.
    

Intervention name(s): temozolomide; laboratory biomarker analysis; liquid chromatography; mass spectrometry; pharmacological study; conventional surgery; stereotactic radiosurgery
Intervention type(s): Drug; Other; Other; Other; Other; Procedure; Radiation
Intervention MeSH terms: Temozolomide
Primary purpose: Treatment
Keywords: tumors metastatic to brain; recurrent adult brain tumor
A Clinical Study of IRL790 in Patients With Parkinson's Disease Experiencing Levodopa Induced Dyskinesia
Condition: Parkinson Disease
MeSH terms: Parkinson Disease; Dyskinesias
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This is a Phase 1b study investigating the safety and tolerability of IRl790 as adjunct
      therapy in patients with Parkinson disease. IRL790/placebo is taken for 28 days.
    

Detailed description: 
      Consenting patients were screened for eligibility as per study-specific inclusion/exclusion
      criteria within 8-28 days before start of Investigational Medicinal Product (IMP)
      administration (Visit 1; Screening Visit). At Visit 2 (Day -7) a kinetigraph device (the
      Parkinson's KinetiGraph™, Global Kinetics Corporation, Melbourne, Victoria, Australia) was
      attached to the right or left wrist (the parkinsonian dominant side) and baseline patient
      movement data were recorded during a run-in period of seven consecutive days.

      Following baseline assessments at Visit 3 (Day 1) patients were randomized to receive IRL790
      or placebo (3:1). The treatment allocation was double-blinded, i.e. it was not disclosed to
      the patients, the site staff or the Sponsor. During the treatment period, Visits 4-8 were
      performed on Days 4, 7, 10, 14 and 28 (end of treatment) and a follow-up phone call was
      performed on Day 21. Dose adjustments of IRL790 could be made until Day 14, following
      pre-defined criteria. A follow-up visit (Visit 9) was performed 7-10 days after the last IMP
      dose.
    

Intervention name(s): IRL790; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): IRL790 capsule 10 mg; Placebo capsule
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Intravenous and Topical Analgesics for Procedural Pain in Neonates
Condition: Pain; Infant, Newborn
Study type: Interventional
Phase: Phase 3

Summary: 
      This study will test which type of pain medication is best for the management of pain in
      newborn preterm and full-term infants having a deep intravenous cannula inserted. It will
      compare the effectiveness of intravenous morphine alone, a local anaesthetic cream
      (amethocaine) alone, and both medications together. It will also determine the safety of both
      medications.
    


Intervention name(s): morphine, amethocaine
Intervention type(s): Drug
Intervention MeSH terms: Morphine; Tetracaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: pain; analgesia; morphine; amethocaine; neonate
The Six Minute Walk Test: Influence of Instruction on Results
Condition: Interstitial Lung Disease
MeSH terms: Lung Diseases; Lung Diseases, Interstitial
Study type: Interventional

Summary: 
      Two - four 6MWT performed according to ATS standards. Each walk however had specifically
      altered wording and coaching performed in random order to determine differences in outcomes.
      One walk was done in the standard ATS fashion. One was done coaching to walk as fast as the
      patient can walk. One was coached to walk at the patients normal walking pace. One was
      coached to walk at the patient's leisure walking pace.
    

Detailed description: 
      Alternate 6MWT where subjects will be asked to walk as fast as they can, walk as normal as
      they can and walk leisurely as they can in 6 minutes compared to standard of care 6MWT which
      is walk as far as you can in 6 minutes.
    

Intervention name(s): alternative six minute walk test; Standard six minute walk test
Intervention type(s): Procedure; Procedure
Intervention description(s): Alternate instructions will be given Subjects will
walk as fast as they can in 6 minutes
walk as normally as they can in 6 minutes
walk leisurely as they can in 6 minutes. Pts will serve as their own controls.; Subjects will walk as far as they can in 6 minutes
Other intervention name(s): fast vs far; far
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: 6 minute walk test; idiopathic pulmonary fibrosis; pulmonary arterial hypertension
The Value of Progesterone for the Timing of the Embryo Transfer in IVF/ICSI: a Prospective Randomised Trial
Condition: Clinical Pregnancy Rate
Study type: Interventional

Summary: 
      At the start of the controlled ovarian stimulation as a part of the IVF/ICSI treatment
      patients are informed about this trial. In case they gave informed consent and they have a
      progesterone level between 1 and 1.5 ng/ml at the day of the hCG injection, they will be
      randomised. One group of patients will have a fresh embryo transfer, in the second group all
      embryos will be cryopreserved and transfered in a subsequent (natural or artificial) cycle.
      The aim of this study is to compare clinical pregnancy rate between the two groups.
    


Intervention name(s): Freeze all
Intervention type(s): Procedure
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
The Cellular Pharmacology of F-TAF in Dried Blood Spots
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      Adherence to daily dosing is very important for how well Emtricitabine/Tenofovir Alafenamide
      (F/TAF) works for treatment of chronic human immunodeficiency virus (HIV), or prevention of
      HIV acquisition. Methods to measure medication adherence to Tenofovir disoproxil fumarate
      (tenofovir DF, TDF), a similar but different prodrug of tenofovir, have been developed but
      cannot be extrapolated to F-TAF. By measuring F-TAF (the drug) and metabolites in the blood
      cells and dried blood spots, the study plans to see if these results predict adherence to
      taking the drug. The goal of this study is to vary the amount of F-TAF dosing and see if the
      drug levels in dried blood spots (DBS) change in a predictable way. This study will mimic
      different levels of adherence (33%, 67%, and 100% of daily dosing) using directly observed
      therapy (DOT) to establish the relationship between F-TAF in dried blood spots and adherence.
      Investigators will also measure drug in hair clippings to see if hair or DBS are a better
      predictor of adherence.
    


Intervention name(s): emtricitabine 200 mg/tenofovir alafenamide 25mg
Intervention type(s): Drug
Intervention description(s): 1 tablet of Descovy contains emtricitabine 200 mg/tenofovir alafenamide 25mg
Other intervention name(s): Descovy
Intervention MeSH terms: Tenofovir; Emtricitabine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: healthy volunteers
A Study To Investigate The Effect Of Food On The Pharmacokinetics Of PH-797804
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to investigate the effect of food on the time course of
      PH-797804 concentration in the blood following dosing by oral immediate release tablet
      formulation.
    


Intervention name(s): PH-797804; PH-797804; PH-797804; PH-797804; PH-797804
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): Tablet, 1 mg, single dose; Tablet, 1 mg, single dose; Tablet, 10 mg, single dose; Tablet, 10 mg, single dose; Tablet, 24 mg, single dose
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science