bioihbjkbjnl/mcl2 huggingface dataset:
A Study in Healthy Volunteers to Compare Different Tablet Formulations of the Test Medicine, GLPG1972, Against the Current Tablet Formulation, and to Assess the Effect Food Has on One of the Test Medicines
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The sponsor wants to investigate two new tablet formulations (recipes) of the test medicine,
      and how they are taken up by the body in comparison to the current tablet formulation (study
      periods 1 to 3). If one of the 2 new tablets has a more favourable profile than the current
      tablet in periods 1 to 3, the sponsor will then investigate the effect that food has on this
      new tablet in study period 4. However, if the new tablets do not have a more favourable
      profile than the current tablet, the food effect does not need to be investigated and study
      period 4 will not be needed.
    


Intervention name(s): GLPG1972 - A; GLPG1972 - B; GLPG1972 - C
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Film-coated tablet, formulation A; Film-coated tablet, formulation B; Film-coated tablet, formulation C
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Individual Differences in Drug Response
Condition: Differential Female Response to Δ9-tetrahydrocannabinol (THC)
Study type: Interventional
Phase: Early Phase 1

Summary: 
      Females are increasingly using cannabis, yet remain underrepresented in preclinical and
      clinical cannabinoid research. This female-specific research plan will test the effects of
      two recreationally relevant doses of oral THC and placebo in healthy females at two phases of
      the menstrual cycle. Acute oral THC will be administered in a double-blind and
      counterbalanced design. Menstrual cycle phase will be determined using blood serum analyses
      of estradiol and progesterone and self-reported responses. The main hypothesis is circulating
      estradiol levels are associated with cardiac, neuroendocrine, and subjective THC response.
      The rationale for the presented work is to better understand the risks of cannabis use, in
      order to maximize possible medical potential and minimize public health risks. The expected
      outcome of this work is a deeper understanding of how circulating estradiol levels may
      associate with response to THC and how the physiological response is associated with the
      subjective response. Uncovering the individual differences in response to THC will allow for
      more preventive action against cannabis-induced anxiety, paranoia, and psychosis.
    


Intervention name(s): Dronabinol; dextrose
Intervention type(s): Drug; Drug
Intervention description(s): THC (Marinol® [dronabinol]; Solvay Pharmaceuticals) will be orally administered in doses of 7.5 mg and 15 mg, in opaque capsules with dextrose filler. Placebo capsules contain only dextrose. These doses of THC are known to produce performance impairments as well as subjective intoxication with little to no adverse reactions in experienced occasional, but non-daily cannabis users (Ménétrey et al., 2005; Issa et al. 2016).; We are administering dextrose to health volunteers for our placebo group
Intervention MeSH terms: Dronabinol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Study to Evaluate Adverse Events and Change in Disease Activity With Oral Tablets of Upadacitinib in Adult Participants With Non-Segmental Vitiligo
Condition: Non-Segmental Vitiligo
MeSH terms: Vitiligo
Study type: Interventional
Phase: Phase 2

Summary: 
      Vitiligo is a common chronic autoimmune disease that causes the body's immune system to
      attack its own pigment producing skin cells. This study is to evaluate how safe and effective
      upadacitinib is in participants with non-segmental vitiligo. Adverse effects and change in
      disease activity will be assessed.

      Upadacitinib is being evaluated for the treatment of non-segmental vitiligo. The study will
      enroll approximately 160 participants aged 18-65 with non-segmental vitiligo in 5 treatment
      arms across 35 sites worldwide.

      Participants will either receive study drug vs placebo oral tablets once daily (QD) for 24
      weeks (Period A). In Period B (up to 52 weeks), participants who received placebo during the
      first 24 weeks will switch to study drug. Participants who received study drug during the
      first 24 weeks, will continue to receive study drug.

      There may be higher treatment burden for participants in this trial compared to their
      standard of care. Participants will attend regular visits during the study at a hospital or
      clinic. The effect of the treatment will be checked by medical assessments, blood tests,
      checking for side effects and completing questionnaires.
    


Intervention name(s): Upadacitinib; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Oral tablets; Oral tablets
Other intervention name(s): ABT-494; RINVOQ
Intervention MeSH terms: Upadacitinib
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Vitiligo; Non-segmental vitiligo (NSV); Upadacitinib; ABT-494; RINVOQ
Normotonic Partial Nephrectomy as Novel Approach in Treating Small Renal Masses
Condition: Renal Malignant Tumor; Renal Tumor
MeSH terms: Carcinoma, Renal Cell
Study type: Interventional

Summary: 
      This study evaluates novel surgical approach in treating small renal masses. Half of
      participants will undergo hypotonic zero-ischaemia partial nephrectomy (standard of care),
      while the other half will undergo normotonic zero-ischaemia partial nephrectomy (experimental
      method).
    

Detailed description: 
      Partial nephrectomy is believed to be the gold standard for treating small renal masses
      (SRM). The warm ischaemia and hypotonic zero-ischaemia approach are widely used techniques of
      care. But they have some negative effects according to renal function (RF) after surgery. We
      decided to compare influence of arterial blood pressure (normotension or hypotension) during
      partial nephrectomy on RF.

      A single-center prospective study comparing normotonic and hypotonic partial nephrectomy will
      be conducted.

      The design involves random allocation of eligible patients to normotonic or hypotonic partial
      nephrectomy group in 1:1 ratio.

      Experimental group - normotonic partial nephrectomy (avoidance of hypotension: mean blood
      pressure more or equal 65 mm Hg).

      Control group - hypotonic partial nephrectomy (using medical hypotension; avoidance of
      hypertension: mean blood pressure less than 65 mmHg

      According to preliminary calculations, taking into account type I error of 5% and power of
      80%, 100 patients should be included in the study. In order to compensate for data loss, the
      estimated sample size is increased by 10%. As a result, the total sample size is 100 +10 =
      110 patients (55 patients for each group). The expected duration of the study is 36 months.
    

Intervention name(s): Normotonic partial nephrectomy; Hypotonic partial nephrectomy
Intervention type(s): Procedure; Procedure
Intervention description(s): partial nephrectomy performing with avoidance of hypotension: mean blood pressure more or equal 65 mm Hg; partial nephrectomy performing with using of medical hypotension; avoidance of hypertension: mean blood pressure less than 65 mmHg
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: partial nephrectomy; zero ischaemia; renal function
Desk Cycling Work Performance Evaluation
Condition: Obesity; Physical Activity; Overweight
MeSH terms: Overweight
Study type: Interventional

Summary: 
      This lab study is evaluating the feasibility of accomplishing productive office work while
      simultaneously pedaling a compact desk-based cycling device.
    


Intervention name(s): Compact Cycling Device
Intervention type(s): Behavioral
Intervention description(s): Participants pedaled a compact cycling device while simultaneously working at a desk.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
OSI-774 (Tarceva) Plus Gemcitabine in Patients With Locally Advanced, Unresectable or Metastatic Pancreatic Cancer.
Condition: Pancreatic Cancer
MeSH terms: Pancreatic Neoplasms
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to determine if OSI-774 will improve overall survival when
      combined with a standard dose of the chemotherapy drug gemcitabine, to individuals with
      pancreatic cancer.
    


Intervention name(s): Tarceva (erlotinib HCl, OSI-774)
Intervention type(s): Drug
Intervention MeSH terms: Erlotinib Hydrochloride
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Tarceva, EGFR, erlotinib, OSI-774
Comparison of Postoperative Analgesic Efficacy of Caudal Block Versus Spinal Block With Levobupivacaine for Inguinal Hernia in Children
Condition: Pain, Postoperative; Analgesia
MeSH terms: Pain, Postoperative; Hernia, Inguinal
Study type: Interventional

Summary: 
      Neuraxial analgesia may improve postoperative outcomes for high-risk children who are
      susceptible to respiratory complications (e.g. post-operative apnea). The use of spinal
      anesthesia in infants and children requiring surgeries of the sub-umbilical regions is
      gaining considerable popularity worldwide. Caudal analgesia along with general anesthesia is
      a very popular regional technique for prolonged postoperative analgesia in different
      pediatric surgical procedures where the surgical site is sub-umbilical. Bupivacaine has been
      thoroughly studied, and a large global experience exists.
    

Detailed description: 
      Neuraxial analgesia may improve postoperative outcomes for high-risk children who are
      susceptible to respiratory complications (post-operative apnea). In this population, spinal
      anesthesia has been proposed as a means to reduce post-operative complications, especially
      apnea and post-operative respiratory dysfunction, although this utility has been questioned.

      Spinal anesthesia modifies the neuroendocrine stress response, ensures a more rapid recovery,
      and may shorten hospital stay with fewer opioid-induced side effects.

      Caudal analgesia along with general anesthesia is a very popular regional technique for
      prolonged postoperative analgesia in different pediatric surgical procedures where the
      surgical site is sub-umbilical. Caudal anesthetics usually provide an-algesia for
      approximately 4-6 hours.
    

Intervention name(s): Levobupivacaine; Levobupivacaine
Intervention type(s): Drug; Drug
Intervention description(s): Plain, isobaric levobupivacaine (0.25%) 1 ml/kg; Plain, isobaric levobupivacaine (0.25%) 0.25 mg/kg
Other intervention name(s): Levobupivacaine hydrate; levobupivacaine hydrate
Intervention MeSH terms: Levobupivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Prevention
Overnight Pant Study for Children With Nocturnal Enuresis
Condition: Nocturnal Enuresis
MeSH terms: Enuresis; Urinary Incontinence; Nocturnal Enuresis
Study type: Interventional

Summary: 
      This study will evaluate the in-use tolerance of an absorbent disposable underwear pant
      developed for children with nocturnal enuresis by assessing adverse events. In addition
      product performance will be assessed by the parent at home via a daily diary.
    


Intervention name(s): Ninjamas Pyjama Pants; Participant's Overnight Current Standard of Care
Intervention type(s): Device; Other
Intervention description(s): Disposable, absorbent underwear-like pyjama pant specifically designed to manage nocturnal enuresis in children by absorbing involuntary urine loss overnight and keeping the child's bed and clothing dry.; Any disposable or reusable absorbent diaper or pant product available on the US market that is used to absorb involuntary urine loss for children who are wetting the bed at night.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Other
Treatment of Keloidscars With Intralesional Triamcinolone and 5-fluorouracil Injections-prospective, Randomized, Controlled Trial - Pilot Study
Condition: Keloidscars
Study type: Interventional
Phase: Phase 4

Summary: 
      The aim of study is examine the efficacy of intralesional 5-fluorouracil injections in keloid
      disease treatment.
    


Intervention name(s): 5-fluorouracil; Triamcinolone
Intervention type(s): Drug; Drug
Intervention description(s): antimitotic drug
Other intervention name(s): Fluorouracil Accord; Lederspan
Intervention MeSH terms: Triamcinolone; Fluorouracil
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Prospective, randomized controlled trial - pilot study
Safety and Immunogenicity of a Candidate Tuberculosis (TB) Vaccine in Healthy HIV Negative Adolescents
Condition: Tuberculosis
MeSH terms: Tuberculosis
Study type: Interventional
Phase: Phase 2

Summary: 
      This observer blind study will assess the safety and immunogenicity of GSK Biologicals'
      investigational 692342 vaccine administered at 0, 1 month to healthy adolescents living in a
      TB-endemic region.
    


Intervention name(s): GSK's investigational vaccine 692342; Placebo
Intervention type(s): Biological; Biological
Intervention description(s): Intramuscular injection, 2 doses; Intramuscular injection, 2 doses
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Tuberculosis vaccine
Long-term Trial on Growth Hormone Deficiency in Adults (GHDA)
Condition: Growth Hormone Disorder; Adult Growth Hormone Deficiency
MeSH terms: Dwarfism, Pituitary; Endocrine System Diseases
Study type: Interventional
Phase: Phase 3

Summary: 
      This trial is conducted in Japan. To investigate the long-term efficacy as assessed by change
      in fat mass and safety after 48 weeks of treatment of Growth Hormone in adults with Growth
      Hormone Deficiency, comparing two different treatment regiments.
    


Intervention name(s): somatropin
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
ZD 1839 in Treating Patients With Prostate Cancer That Has Not Responded to Hormone Therapy
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      RATIONALE: Biological therapies such as ZD 1839 may interfere with the growth of tumor cells
      and slow the growth of prostate cancer. It is not yet known which dose of ZD 1839 is more
      effective in treating prostate cancer that has not responded to hormone therapy.

      PURPOSE: Randomized phase II trial to compare different doses of ZD 1839 in treating patients
      who have prostate cancer that has not responded to hormone therapy.
    

Detailed description: 
      OBJECTIVES:

        -  Compare the efficacy of 2 different doses of ZD 1839, in terms of objective response,
           PSA response, and duration of response, in patients with hormone-refractory
           adenocarcinoma of the prostate.

        -  Compare the tolerability and quantitative toxicity of these regimens in these patients.

        -  Determine whether there is an association between any response or stable disease and
           clinical benefit as assessed by changes in quality of life of patients treated with
           these regimens.

      OUTLINE: This is a randomized, multicenter study. Patients are stratified according to
      measurable disease (yes vs no). Patients are randomized to 1 of 2 treatment arms.

        -  Arm I: Patients receive oral, low-dose ZD 1839 twice daily on day 1 and once daily on
           days 2-28 during course 1 and then once daily on days 1-28 during subsequent courses.

        -  Arm II: Patients receive oral, high-dose ZD 1839 as in arm I. Treatment in both arms
           continues every 4 weeks in the absence of disease progression or unacceptable toxicity.

      Quality of life is assessed at baseline, at the end of each course during study, and then at
      4 weeks after study.

      Patients with stable or responding disease are followed at 4 weeks and then every 3 months
      until disease progression. All other patients are followed at 4 weeks only.

      PROJECTED ACCRUAL: A total of 30-60 patients (15-30 per treatment arm) will be accrued for
      this study.
    

Intervention name(s): gefitinib
Intervention type(s): Drug
Intervention MeSH terms: Gefitinib
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: adenocarcinoma of the prostate; recurrent prostate cancer
Kisspeptin in the Evaluation of Delayed Puberty
Condition: Delayed Puberty; Kallmann Syndrome; Hypogonadotropic Hypogonadism; GnRH Deficiency
MeSH terms: Kallmann Syndrome; Hypogonadism; Puberty, Delayed
Study type: Interventional
Phase: Phase 1

Summary: 
      The goal of this study is to test whether the hormone kisspeptin has the potential to
      prospectively diagnose adolescents with self-resolving or permanent delayed puberty. Some
      children with delayed puberty will eventually enter puberty on their own. However, some
      children with delayed puberty have a permanent condition and require medical treatment to
      undergo puberty. Right now, there is no reliable diagnostic tool to tell whether a child's
      delayed puberty will be self-resolving or permanent. The hormone kisspeptin has the potential
      to prospectively diagnose adolescents with self-resolving or permanent delayed puberty.
    

Detailed description: 
      The investigators are seeking boys (ages 13.5-17 years) and girls (ages 12-17) years with a
      diagnosis of delayed puberty. Study participation involves 2 outpatient visits and two
      hospital admissions (one 11-hour, overnight admission and one 6-hour day admission) when
      subjects will receive two investigational drugs, the naturally occurring hormones kisspeptin
      and gonadotropin-releasing hormone (GnRH). Subjects will then be followed every 6 months
      until they reach 18 years of age to determine if their pubertal delay was self-resolved or
      permanent.
    

Intervention name(s): kisspeptin 112-121; GnRH
Intervention type(s): Drug; Drug
Intervention description(s): 0.24 nmol/kg; 75 ng/kg
Other intervention name(s): metastin 45-54
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: delayed puberty; Kallmann Syndrome; Hypogonadotropic hypogonadism; GnRH Deficiency; kisspeptin; GnRH
A Study to Evaluate the Safety and Efficacy of Topically Applied TV-45070 (Ointment) in Participants With Primary Osteoarthritis (OA) Affecting a Single Knee
Condition: Osteoarthritis of the Knee
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Interventional
Phase: Phase 2

Summary: 
      The primary purpose of the study is to evaluate the change from baseline after 4 weeks of
      topical administration of TV-45070 (4% and 8% ointment) compared with placebo for the relief
      of symptoms of primary OA affecting a single knee
    


Intervention name(s): TV-45070; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): TV-45070 ointment administered twice a day (morning and evening) to target knee. Participants were provided with a laminated instruction sheet including pictures that both described and illustrated how the ointment was to be spread over the entire knee anteriorly, medially, and laterally in a thin layer that fully covered the area. The ointment was gently massaged into the skin.; Placebo ointment matching active intervention administered twice a day (morning and evening) to target knee. Participants were provided with a laminated instruction sheet including pictures that both described and illustrated how the ointment was to be spread over the entire knee anteriorly, medially, and laterally in a thin layer that fully covered the area. The ointment was gently massaged into the skin.
Other intervention name(s): funapide; XEN402
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Osteoarthritis; OA; Arthritis pain
Licorice Botanical Dietary Supplements - Metabolism and Safety in Women
Condition: Food-drug Interaction
Study type: Interventional
Phase: Phase 1

Summary: 
      Human safety studies will be carried out to test whether red clover botanical dietary
      supplements used by peri- and post-menopausal women are safe to use with Food and Drug
      Administration (FDA)-approved drugs. To test this, a red clover dietary supplement
      (previously tested in women at the University of Illinois at Chicago without any harmful
      effects) will be given with four selected FDA-approved drugs to determine if the Licorice
      supplement can increase or decrease how these medications are absorbed, metabolized and
      excreted by the human body. Preclinical studies predict that the licorice supplement might
      affect the metabolism or break down of these probe drugs.
    

Detailed description: 
      At the start of a study, subjects will be administered low doses of a mixture of four
      FDA-approved drugs (caffeine, tolbutamide, dextromethorphan, and alprazolam), and serial
      blood samples will be drawn and analyzed for the concentration of each drug over time.
      Afterwards, participants will take the licorice dietary supplement twice daily for 14 days to
      allow for potential inhibition or induction of drug metabolizing enzymes and transporters.
      Thereafter, the same drugs will be taken again to obtain a second measure of drug
      concentrations in blood over time. Changes in the concentration-time curve values for each
      probe drug obtained before and after ingestion of the supplement would indicate that
      metabolism of the probe drugs is impacted by the licorice dietary supplement.
    

Intervention name(s): Licorice; Alprazolam 2 MG; Caffeine 100 MG; Tolbutamide 250 mg; Dextromethorphan 30mg
Intervention type(s): Dietary Supplement; Drug; Drug; Drug; Drug
Intervention description(s): Experimental :G. glabra Licorice extract: 2 gelatin capsules (75 mg) per day for 14 days; probe substrate; probe substrate; probe substrate; probe substrate
Other intervention name(s): G. glabra; CYP3A4/5 substrate; CYP1A2 substrate; CYP2C9 substrate; CYP2D6 substrate
Intervention MeSH terms: Tolbutamide; Dextromethorphan; Alprazolam; Caffeine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Licorice