bioihbjkbjnl/mcl2 huggingface dataset:
A Study to Determine the Effect of Sumatriptan and Naproxen Sodium Combination Tablet, Sumatriptan Tablet, and Naproxen Sodium Tablet on Blood Pressure When Treating Migraine Headaches That Occur During a 6-month Period
Condition: Migraine Disorders
MeSH terms: Migraine Disorders
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to test the effect on blood pressure of sumatriptan and naproxen
      sodium combination tablets, tablets containing only sumatriptan, and tablets containing only
      naproxen sodium when these drugs are taken to treat migraine headaches that occur during a
      6-month period.
    


Intervention name(s): sumatriptan and naproxen sodium combination tablet; sumatriptan tablet; naproxen sodium tablet
Intervention type(s): Drug; Drug; Drug
Intervention description(s): sumatriptan 85mg and naproxen sodium 500mg; sumatriptan 85mg; Naproxen sodium 500mg
Intervention MeSH terms: Naproxen; Sumatriptan
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: sumatriptan and naproxen sodium; migraine with or without aura; naproxen sodium; sumatriptan; blood pressure; migraine headaches
A Study to Investigate the Tolerability and Effects on Epidermal Nerve Fiber Density of Multiple Low-Concentrations of NGX-1998 in Healthy Volunteers
Condition: Pain
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this single-blinded study in healthy volunteers is to select a
      Low-Concentration Capsaicin Topical Liquid (LC-CTL) to serve as a control formulation in the
      further clinical development of Capsaicin Topical Liquid, NGX-1998 (10% w/w). The goal is to
      identify a low concentration formulation that will not reduce ENFD in healthy normal
      volunteers when compared to NGX-1998 (10% w/w) but would still produce some local
      capsaicin-related application site responses (e.g. erythema, heat sensation or pain) when
      applied.
    

Detailed description: 
      This is a randomized, single center, single-blind controlled study in up to 36 healthy
      volunteers. Each subject will be dosed at four application sites, 7 by 7 cm in size, located
      n the distal and proximal anterior medial thigh areas. At two sites, subjects will receive
      15-minute treatments of a LC-CTL (1%, 0.3%, 0.1%, 0.003% or 0.001% w/w). At the remaining two
      sites, subjects will receive 15-minute treatments of NGX-1998 (10% w/w) and a control liquid
      (CTL-V (0%)). The volume applied at each application site is estimated to be 7 mcl per cm2
      and hence the total volume of approximately 300 mcl of LC-CTL (all concentrations), NGX-1998
      (10% w/w) and CTL-V (0%) applied at each site application will be sufficient to evenly wet
      the surface.

      The top or bottom section of each application site will be pre-treated with lidocaine 2.5% /
      prilocaine 2.5% topical anesthetic cream. These sections are also the sections where the skin
      punch biopsies will be taken. The biopsy will be obtained from these sections as it is
      anticipated that subsequent clinical trials in patients will use pre-treatment with a topical
      anesthetic. However, only the toop or bottom sections will be pre-treated with this topical
      anesthetic so that pre-treatment with the topical anesthetic cream does not interfere with
      tolerability assessments.

      The pharmacodynamic effects of nerve fiber density and function will be evaluated by
      immunohistochemical staining of biopsied tissue from the treatment area. Skin punch biopsies
      at all four application sites will be obtained to evaluate ENFD at 7 days post-application.

      Safety and tolerability will be evaluated by continuous monitoring of adverse events (AEs0
      and periodic assessments of clinical laboratory parameters, vital signs, physical
      examinations, dermal assessments, and pain associated with treatment.
    

Intervention name(s): Capsaicin Topical Liquid
Intervention type(s): Drug
Intervention MeSH terms: Capsaicin
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Single
Primary purpose: Treatment
Keywords: Analgesics; Capsaicin
A Drug-drug Interaction Study With Risdiplam Multiple Dose and Midazolam in Healthy Participants
Condition: Spinal Muscular Atrophy
MeSH terms: Muscular Atrophy; Muscular Atrophy, Spinal
Study type: Interventional
Phase: Phase 1

Summary: 
      This will be a Phase I, 2-part, open-label, non-randomized study to investigate the safety,
      tolerability, and pharmacokinetics (PK) of a multiple-dosing regimen of risdiplam (Part 1)
      and the effect of risdiplam on the PK of midazolam (Part 2) following oral administration in
      healthy adult male and female participants.
    


Intervention name(s): Risdiplam; Midazolam
Intervention type(s): Drug; Drug
Intervention description(s): Part 1: a dose of 5 milligram (mg) risdiplam QD ; Part 2: precise dose will be based on Part 1 results; single dose administration of 2 mg midazolam
Intervention MeSH terms: Midazolam; Risdiplam
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Treatment
ZK283197 for Treatment of Vasomotor Symptoms
Condition: Vasomotor System
Study type: Interventional
Phase: Phase 2

Summary: 
      The primary goal of the planned study is to investigate the efficacy and safety of ZK 283197
      in the dosage of 2 and 3 mg ingested once daily during a period of 8 weeks for the treatment
      of hot flushes. In order to be able to assess the efficacy of the test substance, this is
      compared with the efficacy of 1 mg Estradiol and placebo. The comparator Estradiol is a
      certified hormone preparation, which is already used for the treatment of hot flushes as
      standard treatment. After passing the screening, volunteers will start with a run-in phase
      followed by a 8 weeks treatment and a follow-up phase. 112 postmenopausal women with hot
      flushes and without relevant prior diseases will participate in three European countries (2
      study sites in Germany, 1 study site in Great Britain and 1 study site in The Netherlands) in
      this study.
    


Intervention name(s): BAY 86-5310 (ZK 283197); Placebo; 17ß-estradiol
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 3 mg (3 x 1 mg tablet) or 2 mg (2 x 1 mg tablet) ZK 283197 in respective treatment group, once daily p.o. over 8 weeks; Placebo, once daily p.o. over 8 weeks; 1 mg (2 x 0.5 mg tablet) 17ß-estradiol, once daily p.o. over 8 weeks
Intervention MeSH terms: Estradiol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Hot flushes; Therapy of hot flushes; 17ß-estradiol (E2); Hormone replacement therapy
A Phase 2 Pilot Study to Assess ASP7147 in Patients With Diarrhea Predominant Irritable Bowel Syndrome (IBS-D)
Condition: Diarrhea Predominant Irritable Bowel Syndrome
MeSH terms: Irritable Bowel Syndrome; Syndrome; Diarrhea
Study type: Interventional
Phase: Phase 2

Summary: 
      This trial will evaluate the effect of ASP7147 on daily abdominal pain due to IBS-D during 4
      weeks of treatment. It will also evaluate safety and tolerability in patients with IBS-D over
      the 4-week treatment period.
    


Intervention name(s): ASP7147; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 300 mg, tablet, twice per day for 4 weeks oral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Norepinephrine Infusion Different Doses in Cesarean Delivery
Condition: Cesarean Section Complications
Study type: Interventional
Phase: Phase 4

Summary: 
      three doses (0.025 mcg/Kg/min, 0.050 mcg/Kg/min, and 0.075 mcg/Kg/min) of norepinephrine will
      be compared for prophylaxis against Post-spinal anesthesia hypotension during Cesarean
      delivery.
    

Detailed description: 
      Maternal hypotension is a common complication after spinal anesthesia for cesarean delivery
      (CD). Using vasopressors have been considered a gold standard for prevention of post-spinal
      hypotension (PSH) during CD.

      Norepinephrine (NE) is a potent vasopressor characterized by both α adrenergic agonist
      activity in addition to a weak β adrenergic agonist activity; thus, NE is considered a
      vasopressor with minimal cardiac depressant effect; these pharmacological properties would
      make NE an attractive alternative to phenylephrine and ephedrine (the most commonly used
      vasopressors in obstetric anesthesia).

      Norepinephrine has been recently introduced as a prophylactic vasopressor during CD with
      promising results; However, the optimum dose for efficient prophylaxis with the least side
      effects is not known.

      In this study, three doses (0.025, 0.050, 0.075 mcg/Kg/min) of norepinephrine will be
      compared for prophylaxis against PSH during CD.
    

Intervention name(s): norepinephrine infusion (0.025 mcg/Kg/min); norepinephrine infusion (0.050 mcg/Kg/min); norepinephrine infusion (0.075 mcg/Kg/min); Bupivacaine
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): The patients will receive a bolus of 5 mcg norepinephrine followed by norepinephrine bitartrate infusion of (0.05 mcg/Kg/min) equivalent to norepinephrine base of (0.025 mcg/Kg/min); The patients will receive a bolus of 5 mcg norepinephrine followed by norepinephrine infusion of (0.1 mcg/Kg/min) equivalent to norepinephrine base of (0.050 mcg/Kg/min); The patients will receive a bolus of 5 mcg norepinephrine followed by norepinephrine infusion of (0.15 mcg/Kg/min) equivalent to norepinephrine base of (0.075 mcg/Kg/min).; The patient will receive spinal anesthesia using Bupivacaine (10 mg).
Other intervention name(s): noradrenaline infusion; noradrenaline infusion; noradrenaline infusion; spinal anesthesia; Heavy marcaine
Intervention MeSH terms: Norepinephrine; Bupivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Comparing of Long Bout and Short Bouts of Similar Volume of Walking in Obese on Weight Loss During a Weight Loss Program
Condition: Obesity; Overweight
MeSH terms: Overweight
Study type: Interventional

Summary: 
      The purpose of this present study is to determine if a daily walking program of 50 continuous
      minutes (long bout) or two 25-minute bouts (short bouts) in similar volume on body weight,
      abdominal fat mass deposition and cardiometabolic measures in overweight and obese women
      receiving a low calorie diet for 24 weeks.
    


Intervention name(s): Diet+ short term versus long -term physical activity
Intervention type(s): Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: long bout physical activity; short bout physical activity; Caloric Restriction
Using Virtual Reality to Reduce Procedural Pain in Children With Cancer
Condition: Cancer
MeSH terms: Pain, Procedural
Study type: Interventional

Summary: 
      This study will assess the impact of virtual reality (VR) in decreasing procedural pain
      related to subcutaneous port (SCP) access in children with cancer. The study is a
      pilot-randomized controlled trial (RCT) using a cross-over design that will provide us with
      detailed information on the feasibility of implementing our trial protocol in a future
      multi-center RCT as well as preliminary estimate of VR treatment effect on children with
      cancer undergoing SCP access, including child and parent factors potentially associated with
      VR distraction treatment efficacy.
    

Detailed description: 
      The study is a repeated-measures cross-over pilot RCT to examine the feasibility of the trial
      protocol for a study into the effectiveness of immersive VR in minimizing procedural pain and
      distress in children with cancer. The research objectives are to: (1) pilot implementing
      immersive virtual reality (VR) for effectiveness testing in a future RCT (measured as
      implementation outcomes); (2) determine treatment effect sizes (measured as preliminary
      effectiveness outcomes), between VR, programmed to distract children during an SCP needle
      insertion, and an active control intervention (i.e., watching a video with headphones); and
      (3) assess impact of child and parent factors potentially associated with VR treatment
      effectiveness. Both the intervention and control groups will receive standard medical care
      (e.g., topical anesthetics). A convenience sample of 40 children and adolescents with cancer
      (20 participants per treatment arm; 10 boys and 10 girls per treatment arm) will be
      recruited. In addition, each child will act as their own control. A washout period of 1 month
      will be used to control for any carry-over effect between conditions. In addition to usual
      care, children in the experimental condition will wear the VR headset plus headphones. In the
      control condition, children will watch a video (i.e., an age-appropriate video selected by an
      oncology-affiliated child life specialist) on an iPad, while wearing the same headphones as
      in the experimental condition. Implementation outcomes include accrual and retention rates,
      acceptability and technical difficulties. Effectiveness outcomes include child pain,
      distress, and fear, as well as parent distress.
    

Intervention name(s): Samsung GearVR; iPad
Intervention type(s): Device; Device
Intervention description(s): VR with head mounted display (HMD) and headphones. Treatment; iPad with headphones. Control
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Virtual Reality; Subcutaneous Port Sampling; Pain; Children
IRESSA Combined With Radiotherapy & Gemcitabine as First-Line Treatment in Locally Advanced Pancreatic Cancer
Condition: Pancreatic Cancer
MeSH terms: Pancreatic Neoplasms
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The primary objective of the trial is to identify the dose of gemcitabine given as a 2-hour
      intravenous (iv) infusion that can be administered in combination with ZD1839 250 mg once
      daily and a standard course (45 Grays [Gy]) of radiotherapy in patients with locally
      advanced, unresectable pancreatic cancer.
    


Intervention name(s): Gefitinib; Gemcitabine
Intervention type(s): Drug; Drug
Intervention MeSH terms: Gemcitabine; Gefitinib
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Pancreatic Cancer; EGF-R
Study to Investigate Effect of a New Drug (PF-00446687) in Males Suffering From Erectile Dysfunction
Condition: Erectile Dysfunction
MeSH terms: Erectile Dysfunction
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to investigate the effect of up to 200 mg of PF-00446687 on
      erectile activity in males suffering from erectile dysfunction as well as examining the
      safety and toleration of the drug.
    


Intervention name(s): PF-00446687; Placebo; Placebo; Sildenafil; PF-00446687; PF-00446687; PF-00446687; Placebo; Placebo; Sildenafil
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): Single 200mg dose as an oral solution; Placebo for oral solution; Placebo for tablet; Single oral dose 100 mg tablet; Single 125 mg dose as an oral solution; Single 175 mg dose as an oral solution; Single 20 mg dose as an oral solution; Placebo for oral solution; Placebo for tablet; Single oral dose 100 mg tablet
Intervention MeSH terms: Sildenafil Citrate
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Evaluating VR Therapy Using Cold Pressor Test
Condition: Pain
Study type: Interventional

Summary: 
      This study is testing whether or not low-cost, virtual reality (VR) headsets for mobile
      phones can be used as a potential distractor from pain and thus would have clinical
      applications as a low-cost, non-pharmaceutical method to increase pain tolerance in patients
      undergoing painful or uncomfortable procedures. To do this, the investigators are asking
      volunteers to submerge their hand up to the wrist in cold water (Cold Pressor Test), either
      while playing an interactive virtual reality game on the headset, or while wearing a VR
      headset that is turned off as a control. The investigators will record the participants'
      tolerance to cold water as measured by how long the participants are able to keep their hand
      in the cold water.
    


Intervention name(s): Virtual Reality; Cold Pressor
Intervention type(s): Device; Other
Intervention description(s): Google Cardboard virtual reality headset; A cold ice water bath for use in pain/discomfort simulation
Other intervention name(s): Cold Pressor Test
Intervention MeSH terms: Vasoconstrictor Agents
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: pain tolerance; perioperative pain; virtual reality therapy
Effectiveness of Manual Therapy in Non-specific Low Back Pain
Condition: Physiotherapy Specialty; Low Back Pain
MeSH terms: Back Pain; Low Back Pain
Study type: Interventional

Summary: 
      Low back pain affects many people and involves high medical costs. For this reason, we wish
      to test the efficacy of dry needling VS ischaemic compression in patients with non-specific
      low back pain. To this end, an investigation was carried out on 40 patients diagnosed with
      this ailment, divided into two groups by randomisation to assess the intensity of pain, range
      of movement, pain threshold to pressure and quality of life, measuring these variables prior
      to the intervention, immediately, at 48 hours and one week after the intervention.
    


Intervention name(s): dry needling; ischemic compression
Intervention type(s): Device; Procedure
Intervention description(s): Dry needling of the trigger point of the gluteus medius in patients diagnosed with non-specific low back pain.; Ischaemic trigger point compression of the gluteus medius in patients diagnosed with non-specific low back pain.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: dry needling; low back pain; physiotherapy specialty; pain
Effects of Age and Sex on the Pharmacokinetics of Apremilast in Healthy Adults
Condition: Healthy Volunteer
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of the study is to evaluate the effects of age and sex on the pharmacokinetics
      and safety of a single oral dose of 30 mg apremilast in healthy adults.
    

Detailed description: 
      This is an open-label, parallel group study where eligible elderly adults (aged 65-85 years
      inclusive) and younger adults (aged 18-55 years inclusive) and who are matched to the elderly
      participants by sex and body mass index (BMI) (± 10%) will receive a single dose of 30 mg
      apremilast under fasting conditions.
    

Intervention name(s): Apremilast
Intervention type(s): Drug
Intervention description(s): One oral 30 mg dose of apremilast
Other intervention name(s): CC-10004; Otezla®
Intervention MeSH terms: Apremilast
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Apremilast; pharmacokinetic; safety; Pharmacokinetics and safety in healthy volunteer subjects
Dihydroartemisinin-piperaquine With Low Dose Primaquine to Reduce Malaria Transmission
Condition: Malaria; Asymptomatic Malaria; Plasmodium Falciparum
MeSH terms: Malaria
Study type: Interventional
Phase: Phase 3

Summary: 
      Primaquine (PQ) is currently the only available drug that can clear the mature transmission
      stages of P. falciparum parasites. PQ was previously shown to clear gametocytes that persist
      after artemisinin-combination therapy. A major caveat to the use of primaquine in mass
      adminsitrations for the reduction of malaria transmission is that metabolism of the drug in
      individuals with glucose-6 phosphate dehydrogenase (G6PD) deficiency can lead to transient
      haemolysis. The haemolytic side effect of PQ is dose-related. Haemolysis is more commonly
      observed after prolonged PQ treatment but has also been observed in African populations
      following a single dose of PQ. This haemolysis was self-limiting, largely restricted to G6PD
      deficient individuals and did not lead to clinical symptoms. Nevertheless, any drug-induced
      haemolysis is reason for concern and the World Health Organization has therefore reduced the
      recommended dose of single low dose primaquine from 0.75mg/kg to 0.25mg/kg. This dosage is
      deemed safe without prior G6PD or Hb screening. However, there is limited direct evidence on
      the extent to which this dosage of PQ prevents malaria transmission to mosquitoes.

      In the current study, the investigators will assess the efficacy of DP in combination with
      low-dose PQ to prevent onward malaria transmission. The investigators will perform the
      investigators study in individuals aged 5-15 years who are carry microscopically detectable
      densities of P. falciparum gametocytes. This age group is chosen because asexual parasite
      carriage and gametocyte carriage are common in this age group. All enrolled individuals will
      receive a full three-day course of DP, and will be randomized to receive a dose of primaquine
      or placebo with their third dose. Efficacy will be determined based on gametocyte carriage
      during follow-up, measured by molecular methods. For all individuals, the effect of treatment
      on infectivity to mosquitoes will be assessed by membrane feeding assays at two time points.
    


Intervention name(s): Dihydroartemisinin-piperaquine combination (Artekin); Primaquine
Intervention type(s): Drug; Drug
Intervention description(s): Single-dose 0.25mg/kg
Intervention MeSH terms: Primaquine; Piperaquine; Artenimol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
GB001 in Adult Subjects With Moderate to Severe Asthma
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 2

Summary: 
      A randomized, double-blind, placebo-controlled, dose-ranging, multi-center study to evaluate
      the efficacy and safety of GB001 when added to standard-of care (SOC) asthma maintenance
      therapy in adults with moderate to severe asthma and an eosinophilic phenotype with respect
      to asthma worsening at the end of 24 weeks of treatment.
    


Intervention name(s): GB001; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): film-coated oral tablet; film-coated oral tablet
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: GB001; eosinophilic asthma; moderate asthma; severe asthma