bioihbjkbjnl/mcl2 huggingface dataset:
Study to Determine the Effect of a Newly Formulated Tetracaine Product PET500 on Penile Skin Sensation
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      An open label, placebo and positive controlled, randomised, cross-over study in healthy male
      volunteers to determine the effect on penile skin sensation of a newly formulated tetracaine
      product PET500
    

Detailed description: 
      This was an open label, placebo and positive controlled, randomised, dose-ranging, cross-over
      pilot study.

      On each dosing day the subjects each received one dose of tetracaine (0.26 or 0.65 or 1.3mg),
      or placebo, or Stud100® (which served as a positive control) on the glans penis The doses of
      PET500 were applied in liquid spray form (260μl) at approximately the same time of the day as
      the previous application to locations on the glans penis in a randomised fashion.

      Von Frey hair (monofilaments) was used to assess the changes in touch sensitivity on the
      glans penis after the application of IMP.

      The first two volunteers included in the trial piloted the sensitivity assessments prior to
      the inclusion of all other subjects. Changes could be made to the assessment times on the
      basis of the pilot data to ensure subsequent timings were relevant. However any such changes
      were not to expose volunteers to more assessments than were specified in the study protocol.
    

Intervention name(s): Tetracaine; Matching placebo (PET500); STUD100
Intervention type(s): Drug; Other; Drug
Intervention description(s): Von Frey hair (monofilaments) was used to assess the changes in touch sensitivity on the glans penis after the application of IMP.; Von Frey hair (monofilaments) was used to assess the changes in touch sensitivity on the glans penis after the application of IMP.; Von Frey hair (monofilaments) was used to assess the changes in touch sensitivity on the glans penis after the application of IMP.
Other intervention name(s): PET500 tetracaine spray; PET500 Matching Placebo; STUD100 desensitizing spray for men
Intervention MeSH terms: Tetracaine
Allocation: Randomized
Intervention model: Sequential Assignment
Intervention model description: Von Frey hair (monofilaments) was used to assess the changes in touch sensitivity on the glans penis after the application of IMP.
Masking: None (Open Label)
Primary purpose: Basic Science
Study of Medication Compliance - a Comparison of Patients in Pain Management and Pre-surgical Patients
Condition: Pain
Study type: Observational

Summary: 
      In this study medication compliance regarding current drug use is investigated using
      toxicological analyzes in two patient groups: patients from a pain management department and
      pre-surgical control patients. The aim is to explore the incidence of concealed and feigned
      substances and to determine the respective substance classes. Expecting that noncompliance is
      higher in the pain patient group, the investigators want to identify clinical risk factors
      for noncompliant drug report.
    


Observational model: Case-Crossover
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        pain management and surgical outpatient department of a University hospital
      
Biospecimen description: 
      serum, urine
    
Keywords: medication compliance; adherence; toxicological analyzes; GC-MS; HPLC; pain patients; opioid misuse; patients with current pain
Profile of Pain and Unpleasant Sensations in Patients With Referred Pain
Condition: Referred Pain; Somatic Pain; Neuropathic Pain
MeSH terms: Neuralgia; Pain, Referred; Nociceptive Pain
Study type: Observational

Summary: 
      This feasibility study primarily aimed to assess the technology acceptance and usability of a
      pain tracking software in patients with spinally referred chronic pain. The secondary aim was
      to assess the fluctuations in pain intensity and distribution, using the pain tracking
      software during a 3-month period. Additionally, the study aimed to explore the patients'
      behavior when self-reporting pain when given the opportunity to use a variety of pain quality
      descriptors, such as tingling, burning and stabbing.

      Patients with spinally referred chronic pain will be recruited to participate. Participants
      will be asked to use a pain tracking software to create weekly pain reports for a 3-month
      period. These pain reports consist of pain drawings and intensity scales. Additionally,
      patients will complete baseline disability and pain catastrophizing online questionnaires.
      The project does not affect treatment or does not offer any intervention.
    


Intervention name(s): Patients with referred pain
Intervention type(s): Other
Intervention description(s): The project does not affect treatment or does not offer any intervention.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients with referred pain recruited from advertisement in public areas, social media,
        public and collaborating private clinics and hospitals.
      
Keywords: Pain drawings; referred pain; somatic pain; neuropathic pain; e-health; pain location; biopsychosocial factors; back pain; neck pain; pain extent; function
Evaluation of Galcanezumab in the Prevention of Episodic Migraine- the EVOLVE-1 Study
Condition: Migraine
MeSH terms: Migraine Disorders
Study type: Interventional
Phase: Phase 3

Summary: 
      The main purpose of this study is to evaluate the efficacy of the study drug known as
      galcanezumab in participants with episodic migraine.
    


Intervention name(s): Galcanezumab; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Administered SC; Administered SC
Other intervention name(s): LY2951742
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: prevention; prophylaxis; headache
A Study of Switching to RPV Plus Other ARVs in HIV-1-infected Children (Aged 2 to <12 Years) Who Are Virologically Suppressed
Condition: HIV
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the steady state pharmacokinetics (PK) of
      rilpivirine (RPV) and determine the appropriate dose of RPV in combination with other
      antiretrovirals (ARVs) in participants aged greater than or equal to 2 to less than 12 years
      and to evaluate the safety and tolerability of RPV in combination with other ARVs in
      participants of same age group over a 48-week treatment period with primary endpoint at Week
      24.
    

Detailed description: 
      Participants infected with human immunodeficiency virus type 1 (HIV-1) are routinely treated
      with combinations of multiple drugs which reduces HIV-1 ribonucleic acid (RNA) to
      undetectable levels in a substantial proportion of participants and counteracts the risk of
      viral resistance development. RPV is a potent non-nucleoside reverse transcriptase inhibitor
      (NNRTI) with in vitro activity against wild type (WT) HIV-1 and against NNRTI-resistant HIV-1
      mutants. A medical need still exists for the development of age/weight appropriate
      formulations in children less than (<) 12 years of age. In this study, participants will
      switch to RPV plus other ARVs. The primary analysis will be performed at Week 24. A
      participant will be considered to have completed the study if he or she has completed
      assessments at Week 48 of the study intervention phase. The total study duration for each
      participant, including screening and study intervention phases, will be approximately 54
      weeks. Key efficacy assessments include determination of plasma HIV-1 RNA viral load and
      measurement of CD4+ cell count. Key safety assessments will include the monitoring of
      (serious) adverse events ([S]AEs) and HIV-related events, clinical laboratory tests,
      cardiovascular safety monitoring (vital signs and 12 lead electrocardiogram [ECGs]), and
      physical examination (including growth).
    

Intervention name(s): Rilpivirine; ARV Background Regimen
Intervention type(s): Drug; Drug
Intervention description(s): Rilpivirine 25 mg tablets for the 25 mg daily dose, or tablets for or a weight-adjusted dose. Administered orally once daily.; The investigator-selected ARVs, including but not limited to N(t)RTIs (example, azidothymidine [AZT], abacavir [ABC], tenofovir alafenamide [TAF], or tenofovir disoproxil fumarate [TDF] in combination with emtricitabine [FTC] or lamivudine [3TC]), whichever are approved and marketed or considered local standard of care for children aged between 2 and < 12 years in a particular country are to be administered. Integrase inhibitors (for example, dolutegravir [DTG] or raltegravir) can also be administered in combination with RPV, as appropriate.
Other intervention name(s): TMC278
Intervention MeSH terms: Rilpivirine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Study to Evaluate Flexible Dose of Paliperidone Extended Release (ER) and Clinical Response in Participants With Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to evaluate the effectiveness of paliperidone ER for the
      treatment of schizophrenia (psychiatric disorder with symptoms of emotional instability,
      detachment from reality, often with delusions and hallucinations, and withdrawal into the
      self) participants.
    

Detailed description: 
      This is a multi-center (when more than one hospital or medical school team work on a medical
      research study), open-label (all people know the identity of the intervention), prospective
      (study following participants forward in time), non-comparative study. The total study
      duration will be 12 weeks for each participant and will include following visits: Screening,
      Week 2, 4, 8, and 12 (end of treatment or early withdrawal). The effectiveness of
      paliperidone ER will be evaluated at Week 12 by the proportion of responders who are
      evaluated as "very much improved" or "much improved" on the Clinical Global Impression
      improvement (CGI-I) Scale. Participants' safety will also be monitored throughout the study.
    

Intervention name(s): Paliperidone ER
Intervention type(s): Drug
Intervention description(s): Participants will receive paliperidone ER 6 milligram (mg) orally once daily up to Week 12. Dose adjustment will be done at Week 2, 4 and 8 as per investigator's discretion based upon participant's CGI-I score.
Intervention MeSH terms: Paliperidone Palmitate
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Schizophrenia; Paliperidone Extended Release (ER)
Patients Navigator for Organized Colorectal Cancer Screening
Condition: Healthy
MeSH terms: Colorectal Neoplasms
Study type: Interventional

Summary: 
      The main objective is to evaluate the impact of the recruitment and training of a
      peer-navigator on the participation rate of colorectal cancer screening among underserved
      area. The role of the navigator is to establish an intervention culturally-tailored to the
      inhabitants in order to promote the Fecal Occult Blood test (FOBT) and accompany the
      inhabitants to complementary exams, if needed.
    


Intervention name(s): Navigator intervention
Intervention type(s): Behavioral
Intervention description(s): peers sharing common characteristics with the target population whose mission is to accompany towards OCCS
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Early Progesterone Cessation After in Vitro Fertilization
Condition: All Patients Which Show a Gestational Sac in Their Uterus in the First US Are Included in This Study and Randomized.
Study type: Interventional
Phase: Phase 4

Summary: 
      There seems to be a general consensus on the supplementation of progesterone (P4) for luteal
      phase support (LPS) to all women after in vitro fertilization (IVF) treatment. However, there
      is no agreement about the precise duration of LPS.
    

Detailed description: 
      The objective of the study is to investigate the effect of early cessation of progesterone
      for LPS after IVF treatment on the pregnancy outcome, with special interest in determining
      the miscarriage rate and episodes of bleeding between the date of the first ultrasound (US)
      and up to 12 weeks of gestation.

      Patients start to receive 200 mg twice a day of P4 on the day after oocyte retrieval.

      All patients which show a gestational sac in their uterus in the first US are included in
      this study and randomized.

      Inclusion criteria:

        1. Patients who underwent ovarian stimulation using GnRH analogues,

        2. Fresh embryo transfer,

        3. LPS by vaginal micronized P4,

        4. Clinical pregnancy demonstrated by US and

        5. Informed consent signed.

      Exclusion criteria:

      Patients who had bleeding episodes before their first US because they are likely to continue
      P4 therapy without medical indication.
    

Intervention name(s): Cease progsterone at 5; control group: progesterone 8
Intervention type(s): Other; Other
Intervention description(s): Cease administration of progsterone at first US at 5 weeks; Control group: progesterone until 8 weeks of pregnancy
Intervention MeSH terms: Progesterone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
The Effect of a Healthy Snack on Radiance, Aging and Inflammation of the Skin
Condition: Skin Laxity
MeSH terms: Inflammation
Study type: Interventional

Summary: 
      The anti-oxidative and anti-inflammatory effects of polyphenolic compounds of almonds have
      been reported in limited animal studies and may have the potential to improve skin radiance.
      However, the skin related beneficial properties of almonds have not been investigated in
      humans. This study will examine the effects of almond consumption on human skin radiance in
      Asian women as a pilot.
    

Detailed description: 
      This study is a randomized, parallel group comparison of almonds vs. isocaloric pretzels
      carried out in accordance with the guidelines of the Human Subjects Protection Committee of
      the University of California, Los Angeles. All subjects will give written informed consent
      before the study begins. Subjects will consume 1.5 serving of almonds (~ 1.5 oz/d for
      246kcal) or isocaloric pretzels (~ 2.0 oz/d for 216kcal) daily for 12 weeks and will undergo
      skin assessment at weeks 0, 4, 8 and 12. The assessments include skin radiance, sebum, and
      hydration/moisture. In addition the study will evaluate the effect of almond consumption on
      skin inflammation and aging by assessing UV-induced changes. Each group will have 20
      subjects.
    

Intervention name(s): Almond; Pretzel
Intervention type(s): Other; Other
Intervention description(s): Consume 1.5 oz. serving almonds (246 calories) daily for 12 weeks; Consume 2 oz. serving of pretzels (216 calories) daily for 12 weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: This study will be a randomized, parallel group comparison of almonds vs. isocaloric pretzels.
Masking: None (Open Label)
Primary purpose: Other
Keywords: skin; aging; almonds
Evaluating the Effects of Electroacupuncture and Rosiglitazone Combined Therapy
Condition: Type 2 Diabetes Mellitus With Features of Insulin Resistance
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2; Insulin Resistance
Study type: Interventional
Phase: Phase 2

Summary: 
      Aims: To evaluate the efficacy of rosiglitazone (TZD) and electroacupuncture (EA) combined
      therapy on patients with type 2 diabetes mellitus (T2DM). A randomized single-blind placebo
      controlled clinical trial was used.

      Methods: A total of 31 newly diagnostic type 2 diabetic patients, who fulfilled the
      eligibility criteria were recruited and received various allocated interventions. They were
      randomly assigned into two groups, the control group (TZD, N=15) and the experimental group
      (TZD + EA, N=16). Changes in their plasma free fatty acid (FFA), glucose and insulin levels
      together with their homeostasis model assessment (HOMA) indices were statistically assessed
      between before and after treatment. Hypoglycemic activity (%) was also compared between these
      two groups.

      Expecting Results: This study will compare the hypoglycemic activity and the ability of
      improving insulin resistance between the TZD and TZD+EA group. Also, the lowering effect of
      the plasma FFA concentration will be investigated.
    

Detailed description: 
      This study is compared the effect between combined therapy (EA+TZD) and drug (TZD) on the
      patient of type 2 DM.
    

Intervention name(s): EA + Rosiglitazone; TZD
Intervention type(s): Other; Drug
Intervention description(s): electroacupuncture and Rosiglitazone combined therapy on patient of type II DM; Rosiglitazone 8 mg single dose
Other intervention name(s): Electroacupuncture and Rosiglitazone combined therapy; The effect of hypoglycemia and improving insulin sensitivity
Intervention MeSH terms: Rosiglitazone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: electroacupuncture; rosiglitazone; plasma glucose; insulin resistance; free fatty acid
A Phase 1 Study to Evaluate Effects of Sapropterin Dihydrochloride on QTc Intervals in Healthy Adult Subjects
Condition: Phenylketonuria
MeSH terms: Phenylketonurias
Study type: Interventional
Phase: Phase 1

Summary: 
      Sapropterin dihydrochloride (subsequently referred to as sapropterin) (Kuvan®) was approved
      by the FDA for the treatment of hyperphenylalaninemia in 2007. Preclinical and clinical
      studies and post-marketing surveillance have not demonstrated any specific cardiovascular
      concerns with sapropterin (Kuvan®). Nonetheless, nonantiarrhythmic drugs may have the
      potential to prolong QT interval, leading to potentially fatal ventricular tachycardias,
      including torsades de pointes. As part of the post-marketing commitment, a thorough QT/QTc
      study will be conducted according to ICH guidelines.
    


Intervention name(s): sapropterin dihydrochloride; Moxifloxacin; Moxifloxacin placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 20 mg/kg and 100 mg/kg; Moxifloxacin is included as a positive control to demonstrate the assay sensitivity based on the expected increased QTc response.; Moxifloxacin placebo tablet
Other intervention name(s): Kuvan
Intervention MeSH terms: Moxifloxacin; Norgestimate, ethinyl estradiol drug combination
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Hyperphenylalanemia due to Phenylketonuria
Evaluating Intensive Group Behavioral Treatment for Children With Selective Mutism
Condition: Selective Mutism
MeSH terms: Mutism
Study type: Interventional

Summary: 
      This goal of this study is to evaluate an intensive group behavioral treatment (IGBT) program
      for children with selective mutism, a low base-rate childhood anxiety disorder. 29 children
      between the ages of 5 and 9 will be randomly assigned to participate in a 5-day IGBT over the
      summer or to a waitlist control condition, with the opportunity to participate in IGBT 4
      weeks later. All children that participate in treatment will be followed up 8 weeks into the
      following school year.
    


Intervention name(s): Intensive Group Behavioral Treatment (IGBT)
Intervention type(s): Behavioral
Intervention description(s): IGBT is a 5-day intensive treatment program, where cognitive behavioral therapy is provided to children and their parents delivered over 6-8 hours per day over the course of 5 days.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Families of children with selective mutism will be randomly assigned to receive either immediate intensive group behavioral treatment (IGBT) or to a waitlist with psychoeducational materials, and then IGBT.
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Selective Mutism; Treatment; Anxiety; Intensive Treatment; CBT; Group Treatment
A Study to Characterize the Drug Levels of an Oral Contraceptive With and Without BMS-986166 in Healthy Female Participants of Childbearing Potential
Condition: Healthy Participants
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to investigate the potential for a drug-drug interaction (DDI)
      when BMS-986166 and hormonal oral contraceptives are co-administered.
    


Intervention name(s): BMS-986166; Oral contraceptive
Intervention type(s): Drug; Drug
Intervention description(s): Specified dose on specified days; Specified dose on specified days
Intervention MeSH terms: Contraceptive Agents; Contraceptives, Oral
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Healthy Participants; BMS-986166
Montelukast in Pediatric Patients Aged 6 to 24 Months With Asthma--Safety Study (0476-176)
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional

Summary: 
      A study of Montelukast compared to placebo in asthmatic children aged 6-24 months.
    


Intervention name(s): montelukast sodium; Comparator: Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Montelukast 4-mg oral granules mixed with applesauce once daily at bedtime for 6 weeks; Placebo oral granules mixed with applesauce once daily at bedtime for 6 weeks
Intervention MeSH terms: Montelukast
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
An Open Label, Single Dose, Three Part Study to Assess the Effects of Rolapitant (2 mg/mL IV Solution) on the Pharmacokinetics of Digoxin; Sulfasalazine; and the Cooperstown Cocktail (Midazolam, Omeprazole, Warfarin, Caffeine, and Dextromethorphan in Healthy Subjects
Condition: Chemotherapy-induced Nausea and Vomiting
MeSH terms: Vomiting
Study type: Interventional
Phase: Phase 1

Summary: 
      The objective of this Open Label Study is to evaluate effects of Rolapitant IV solution, and
      its metabolite, on the pharmacokinetics (PK) of the P-gp substrate (digoxin), the BCRP
      substrate (sulfasalazine), and multiple cytochrome P450 (CYP) probe substrates in a healthy
      adult population.
    

Detailed description: 
      -  Part A will compare the PK of oral digoxin alone and in combination with an IV infusion
           of rolapitant.

        -  Part B will compare the PK of an oral dose of sulfasalazine alone to the PK of an oral
           dose of sulfasalazine in combination with an IV infusion of rolapitant

        -  Part C will compare the PK of an oral dose of the Cooperstown Cocktail (midazolam,
           omeprazole, warfarin, caffeine, and dextromethorphan) alone and when given in
           combination with an IV infusion of rolapitant.
    

Intervention name(s): Rolapitant; Digoxin; Sulfasalazine; Cooperstown Cocktail
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): P-gp substrate; BCRP substrate; Midazolam, omeprazole, warfarin, caffeine, and dextromethorphan
Intervention MeSH terms: Sulfasalazine; Digoxin; Rolapitant
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science