bioihbjkbjnl/mcl2 huggingface dataset:
Effect of Flutamide on Biomarkers in Blood and Tissue Samples From Patients at High Risk of Ovarian Cancer
Condition: Ovarian Cancer
MeSH terms: Ovarian Neoplasms; Carcinoma, Ovarian Epithelial
Study type: Interventional
Phase: Phase 2

Summary: 
      Studying samples of blood and tissue in the laboratory from patients with a high risk of
      developing ovarian cancer may help doctors identify and learn more about biomarkers related
      to cancer. We hypothesized that (i) preclinical biologic evidence exists for the role of
      androgens in ovarian cancer development and (ii) flutamide treatment of women at high risk
      for ovarian cancer may identify meaningful tissue biomarkers of androgen action and of
      ovarian cancer initiation. This phase II trial studied the effect of flutamide on biomarkers
      in blood and tissue samples from patients at high risk of ovarian cancer.
    

Detailed description: 
      OBJECTIVE: Compare the biomarkers of patients at high risk for ovarian cancer who are
      undergoing prophylactic oophorectomy and are interested in taking flutamide vs patients at
      high risk for ovarian cancer who are undergoing prophylactic oophorectomy and are not
      interested in taking flutamide (control) vs patients who are undergoing oophorectomy for a
      medical indication (control).

      OUTLINE: Patients who elected not to receive flutamide received prophylactic oophorectomy or
      oophorectomy for a medical indication. Patients who elected to receive flutamide received
      125mg once daily for 6 weeks in the absence of unacceptable toxicity. Patients then underwent
      prophylactic oophorectomy. All patients underwent blood and ovarian tissue sample collection
      at the time of surgery for biomarker laboratory studies. Proteomic, microarray, and
      polymorphism analysis were performed on the blood and tissue samples.
    

Intervention name(s): flutamide
Intervention type(s): Drug
Intervention description(s): Patients receive oral flutamide (125 MG/DAY) once daily for 6 weeks in the absence of unacceptable toxicity.
Other intervention name(s): Eulexin; Cytomid; Cebatrol; Chimax; Drogenil; Flucinom; Flutamin; Fugerel; Niftolide; Sebatrol
Intervention MeSH terms: Flutamide
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Ovarian epithelial cancer; High risk; Biomarkers
Phase I Multiple Ascending Dose Study for AZD 7268 in Healthy Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      Multiple Ascending Dose Study
    


Intervention name(s): AZD7268; AZD7268; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Capsule, Oral, QD; Capsule, Oral, BID; Capsule, Oral BID
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Keywords: Phase 1; Healthy Volunteer
Pharmacokinetics of HCP1401 and Co-administration of HCP0605, HGP1405 in Healthy Male Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      A randomized, open-label, oral single dose, two-way crossover clinical trial to compare the
      pharmacokinetics and safety/tolerability after administration of HCP1401 and
      co-administration of HCP0605 and HGP1405 in healthy male volunteers
    

Detailed description: 
      The purpose of this study is to investigate the pharmacokinetics and safety/tolerability
      after administration of HCP1401 and co-administration of HCP0605, HGP1405 in healthy male
      volunteers
    

Intervention name(s): HCP0605; HGP1405; HCP1401
Intervention type(s): Drug; Drug; Drug
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Study of JNJ-70033093 and Digoxin in Healthy Participants
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the potential pharmacokinetic (PK) interaction
      between JNJ-70033093 and digoxin in healthy participants after single dose administration and
      at steady state.
    


Intervention name(s): JNJ-70033093; Digoxin
Intervention type(s): Drug; Drug
Intervention description(s): Participants will receive JNJ-70033093 orally.; Participants will receive digoxin orally.
Other intervention name(s): BMS-986177; Lanoxin
Intervention MeSH terms: Digoxin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Randomized, Open Label Study of Dabigatran Etexilate in Elective Percutaneous Coronary Intervention
Condition: Heart Catheterization
Study type: Interventional
Phase: Phase 2

Summary: 
      To assess whether two doses of dabigatran etexilate (110 mg twice daily (b.i.d) and 150 mg
      twice daily (b.i.d)) as compared to unfractionated heparin (UFH), both in addition to a
      standard dual antiplatelet regimen, provide sufficient anticoagulation in the setting of
      elective percutaneous coronary intervention (PCI).
    


Intervention name(s): dabigatran 110 mg; dabigatran 150 mg; unfractionated heparin
Intervention type(s): Drug; Drug; Drug
Intervention description(s): comparison of different dabigatran dosages with unfractionated heparin; comparison of different dabigatran dosages with unfractionated heparin; comparison of different dosages dabigatran with unfractionated heparin
Intervention MeSH terms: Heparin; Calcium heparin; Dabigatran
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Paroxetine for the Treatment of Interferon Related Side Effects for Hepatitis C
Condition: Hepatitis C; Depression; Interferon-alpha Associated Side Effects
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis; Depression
Study type: Interventional

Summary: 
      A.OVERVIEW

      This is a 26 week study examining the ability of paroxetine (Paxil) to prevent the
      development of depression and neurotoxicity in patients receiving either 3 million units of
      subcutaneous IFN(interferon-alpha-2b) 3 times/week (plus ribavirin, 1000-1200 mg/d)) or PEG
      (polyethylene glycol) interferon-alpha-2b (1.5 micrograms/kg one time a week) and ribavirin
      (800 to 1,400 mg a day) for chronic hepatitis C (CHC). The IFN plasma half life (t1/2 of 24
      to 34 hours) of PEG, a CHC treatment recently approved by the FDA, is significantly prolonged
      allowing for once a week dosing. Studies indicate that the side effect profile of the two
      forms of IFN-alpha treatment are very similar. CHC patients will be screened for study
      eligibility, and a total of 100 CHC patients between the ages of 18 and 65 years old will be
      enrolled across three sites (30 at Emory site and a combination of 30 from the University of
      Pennsylvania, Rush-Presbyterian-Saint Lukes Medical Center in Chicago and Montefiore Medical
      Center in New York.) Two weeks prior to treatment with subcutaneous IFN-alpha-2b, patients
      who meet inclusion and exclusion criteria will be stratified on the basis of a history of
      major depression and then randomly assigned to paroxetine or placebo in double blind fashion.
    


Intervention name(s): paroxetine
Intervention type(s): Drug
Intervention MeSH terms: Paroxetine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Prevention
Keywords: Hepatitis C; Interferon-alpha associated side effects; Antidepressants; Prevention
Study to Evaluate the Efficacy and Safety of OraVescent Fentanyl Citrate Treatment for the Management of Breakthrough Pain in Opioid-Tolerant Patients With Noncancer-Related Chronic Pain
Condition: Pain
MeSH terms: Chronic Pain; Breakthrough Pain
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of the study is to evaluate the efficacy and safety of OraVescent fentanyl
      treatment compared to placebo treatment monthly over a 12-week treatment period in
      alleviating breakthrough pain (BTP) in opioid-tolerant patients with noncancer-related
      chronic pain.
    


Intervention name(s): OraVescent Fentanyl
Intervention type(s): Drug
Intervention MeSH terms: Fentanyl
Allocation: Randomized
Masking: Double
Primary purpose: Treatment
Keywords: diabetic peripheral neuropathy; postherpetic neuralgia; traumatic injury; complex regional pain syndrome; back pain; neck pain; fibromyalgia; chronic pancreatitis; osteoarthritis
Study Evaluating Bazedoxifene/Conjugated Estrogens Combinations In Postmenopausal Women
Condition: Endometrial Hyperplasia; Osteoporosis
MeSH terms: Osteoporosis; Endometrial Hyperplasia; Hyperplasia
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to determine whether bazedoxifene/conjugated estrogens
      combinations are effective for the prevention of endometrial hyperplasia and for the
      prevention of osteoporosis in postmenopausal women.
    


Intervention name(s): Bazedoxifene/Conjugated Estrogen; Bazedoxifene/Conjugated Estrogen; CE 0.45 mg/MPA 1.5mg; Placebo
Intervention type(s): Drug; Drug; Drug; Other
Intervention description(s): Subjects will take 1 capsule orally, once daily, at approximately the same time each day continuously for the duration of the study.; Subjects will take 1 capsule orally, once daily, at approximately the same time each day continuously for the duration of the study.; Subjects will take 1 capsule orally, once daily, at approximately the same time each day continuously for the duration of the study.; Subjects will take 1 capsule orally, once daily, at approximately the same time each day continuously for the duration of the study.
Intervention MeSH terms: Bazedoxifene; Estrogens; Estrogens, Conjugated (USP)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: Endometrium; Uterus; Menopause
Telomere Length in Relation to Acute Stress Response in Critical Care Patients
Condition: Acute Disease; Telomere Shortening
MeSH terms: Acute Disease
Study type: Observational [Patient Registry]

Summary: 
      the investigators studied the impact of severe stress (in this case any event or illness
      leading to a necessity of critical care) on telomere length.
    

Detailed description: 
      Telomeres length analysis were determined from 2 blood samples, the initial sample drawn in
      the first 72 hours after hospitalization and the second after not < 5 or > 14 days. For
      patients discharged before day 5, a repeat sample was drawn and analyzed on the discharge
      day. The blood sample processing was as follows: 5 ml of blood was collected and the red
      blood cells (RBC) were lysed using the RBC lysis solution (Biological Industries, Beit
      Haemek, Israel). Isolation of genomic DNA was performed by using the DNA isolation kit for
      mammalian blood (Roche, Mannheim, Germany). Briefly, DNA was isolated by the salting out
      procedure, washed and precipitated by isopropanol. The DNA was resuspended in polymerase
      chain reaction (PCR) grade water. The DNA concentration was measured by using the NanoDrop
      device (Thermo Fisher, USA).

      DNA samples were analyzed for telomere length according to the method of Cawthon (2009) [20]
      with slight modifications. Each DNA sample was analyzed by two sets of primers detailed
      below, one for telomere length analysis and one for a reference gene analysis (human
      hemoglobin). The primers were diluted to 100µM in PCR grade water and then to 10µM. DNA
      samples were diluted to 2.5 ng/µl in PCR grade water. The primers sequences are shown below:

      telc: TGTTAGGTATCCCTATCCCTATCCCTATCCCTATCCCTAACA telg:
      ACACTAAGGTTTGGGTTTGGGTTTGGGTTTGGGTTAGTGT hbgd:_GCCCGGCCCGCCGCGCCCGTCCCGCCGGAGGAGAAGTCTGCCGTT
      hbgu: GGCGGCGGGCGGCGCGGGCTGGGCGGCTTCATCCACGTTCACCTTG

      Reaction PCR were processed as follows:

      50°C for 2 min, 95°C for 5 min, a single cycle of 94°C for 15 sec, 49°C for 15 sec; 40 cycles
      of: 94°C for 15sec, 62°C for 10 sec and a final stage of: 74°C for 15 sec. All reactions were
      performed using the Step One device (ABI, USA).
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        adults (male and females) admitted to the ICU
      
Biospecimen description: 
      telomere extracted from white blood cells (WBC) anonymously
Lakeshore Examination of Activity and Disability Exercise Response Study
Condition: Multiple Sclerosis; Stroke
MeSH terms: Multiple Sclerosis; Sclerosis
Study type: Interventional

Summary: 
      This study will examine the effectiveness of two types of group exercise classes on the
      health and functional status in inactive adults age 18-65 with neurological conditions
      including Multiple Sclerosis, stroke, and spinal cord injury (SCI). Participants will be
      randomly assigned to one of three groups; Movement to Music, Adapted Yoga, or a waitlist
      group who will complete a home-based exercise intervention of either Movement to Music or
      Adapted Yoga.
    


Intervention name(s): Movement to Music; Adapted Yoga
Intervention type(s): Behavioral; Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Supportive Care
One Month Daily Wear Clinical Evaluation of New Prototype Contact Lenses in Habitual and Neophyte Contact Lens Wearers
Condition: Visual Correction
Study type: Interventional

Summary: 
      There will be four study lenses tested; one marketed lens, and three prototype study lenses.
      Subjects will be randomized to one of the four study lenses which will be worn in a daily
      wear modality, with a two week replacement.
    


Intervention name(s): ACUVUE 2; Prototype E1; Prototype E2; Prototype E3
Intervention type(s): Device; Device; Device; Device
Intervention description(s): worn in a daily wear modality; lenses will be replaced after 2 weeks; worn in a daily wear modality; lenses will be replaced after 2 weeks; worn in a daily wear modality; lenses will be replaced after 2 weeks; worn in a daily wear modality; lenses will be replaced after 2 weeks
Other intervention name(s): Investigational soft contact lens; Investigational soft contact lens; Investigational soft contact lens
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
The Effects of Prazosin on Dopamine in Healthy Humans: A PET Pilot Study
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to find out whether short term treatment with a antihypertensive
      medication prazosin, can influence the levels of a dopamine in the brain. We will examine the
      levels of dopamine in the the brain using Positron Emission Tomography (PET) and Magnetic
      Resonance Imaging (MRI). We hypothesize that there will be no significant changes in dopamine
      levels in healthy individuals taking prazosin.
    

Detailed description: 
      The purpose of this study is to find out whether short term treatment with a antihypertensive
      medication prazosin, can influence the levels of dopamine in the brain. We will examine the
      levels of dopamine in the the brain using Positron Emission Tomography (PET) and Magnetic
      Resonance Imaging (MRI). The study will involve three PET scans and one MRI. One PET scan
      will be performed before the participants take prazosin for approximately three weeks, and
      the last two PET scans will be performed after the prazosin medication phase. We hypothesize
      that there will be no significant changes in dopamine levels in healthy individuals taking
      prazosin.
    

Intervention name(s): Prazosin Hydrochloride
Intervention type(s): Drug
Intervention description(s): Gradual upward titration to 15mg/day for approximately three weeks.
Other intervention name(s): Teva-Prazosin; Prazosin; Minipress
Intervention MeSH terms: Prazosin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: prazosin; dopamine; healthy; Positron Emission Tomography; PHNO; scan; effect
GnRH Antagonist Versus GnRH Agonist in Polycystic Ovary Syndrome During in Vitro Fertilization - Embryo Transfer
Condition: Infertility; Polycystic Ovary Syndrome
MeSH terms: Polycystic Ovary Syndrome; Infertility; Syndrome
Study type: Interventional
Phase: Phase 3

Summary: 
      GnRH (Gonadotropin-releasing hormone) antagonists in IVF (in vitro fertilization) has been
      accomplished by several randomized controlled trials compared with conventional GnRH agonist
      long protocol in polycystic ovary syndrome (PCOS) patients. Moreover, there are debating
      issues that refer to the timing of GnRH antagonist initiation. The purpose of this study is
      to investigate the laboratory and clinical priority during ovarian stimulation for IVF in
      patients with PCOS treated with three different protocols.
    

Detailed description: 
      GnRH Antagonist is Started on Stimulation Day 1 GnRH Antagonist is Started on Stimulation Day
      6 Conventional GnRH Agonist Long Protocol
    

Intervention name(s): GnRH antagonist (Cetrorelix); Conventional GnRH agonist (Triptorelin)
Intervention type(s): Drug; Drug
Intervention description(s): In the first arm, cetrotide will be administrated from the first day during stimulation. In the second arm, cetrotide will be administrated from the sixth day during stimulation; Patients in the agonist group were administered GnRH agonist started 5 days before discontinuation of the oral contraceptive.
Other intervention name(s): Cetrotide; Decapeptyl
Intervention MeSH terms: Triptorelin Pamoate; Cetrorelix; Prolactin Release-Inhibiting Factors
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Polycystic ovary syndrome; ovulation induction; In vitro fertilization-embryo transfer
Dipole Density Mapping in Supraventricular Tachycardia
Condition: Supraventricular Tachycardia
MeSH terms: Tachycardia; Tachycardia, Supraventricular
Study type: Interventional

Summary: 
      Use of dipole density mapping to identify activation in complex supraventricular
      tachycardias.
    

Detailed description: 
      The research study was conducted in multiple countries throughout the EU and Canada. The
      protocol and their corresponding NCT numbers are as follows:

      NCT01914549 (Protocol CL-SVT-001, Site Belgium, Bruges Dr. Duytschaever = PI) NCT01875614
      (Protocol CL-SVT-002, Sites in the UK, Drs. Grace, Hall, & Schilling = PIs) NCT03368781
      (Protocol CL-SVT-004, Site Hamburg, Germany Prof. Willems = PI) NCT02469623 (Protocol
      CL-SVT-005, Site Prague, Czech Republic Prof. Neuzil = PI) NCT02469636 (Protocol CL-SVT-006,
      Site Santiago, Chile Dr. Bittner = PI) NCT02469649 (Protocol CL-SVT-008, Site Ontario, Canada
      Dr. Verma = PI)

      All of the above records were combined into one as all protocols were essentially identical
      and one study report was written that encompasses the data/results for all protocols.
    

Intervention name(s): Dipole Density Mapping with AcQMap followed by ablation
Intervention type(s): Device
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Effect of Hepatic Impairment on the Pharmacokinetics of a Single Dose of TD-9855
Condition: Symptomatic Neurogenic Orthostatic Hypertension; nOH
MeSH terms: Hypertension
Study type: Interventional
Phase: Phase 1

Summary: 
      An open-label study to characterize the effects of mild, moderate, and severe Hepatic
      Impairment (HI) on the pharmacokinetics (PK) of ampreloxetine following a single oral dose in
      comparison with healthy volunteers with normal hepatic function.
    

Detailed description: 
      This is a multicenter, non-randomized, open label, parallel group, single dose, 2-part study
      being conducted in adult subjects with mild, moderate, or severe HI (Child-Pugh Class A, B,
      and C), and in matching healthy subjects. The healthy matching group will be comparable to
      the corresponding hepatic impairment groups by matching subjects by weight (±20% of group
      mean), age (±10 years of group mean), and sex (equal ratios across groups).

      The study will be conducted in two sequential parts:

      In Part A, following a 28-day screening period, 6 subjects each with mild or moderate HI and
      6 matching healthy subjects who meet eligibility criteria will be enrolled and administered a
      single Dose A (Day 1).

      In Part B, following a 28-day screening period, 6 subjects with severe hepatic impairment
      will receive a single Dose A (Day 1). Furthermore, the Sponsor may choose to enroll up to 6
      additional healthy subjects in Part B to ensure matching of subjects across all groups for
      weight, age, and sex is maintained.
    

Intervention name(s): Ampreloxetine
Intervention type(s): Drug
Intervention description(s): The study drug will be administered orally as a single Dose A tablet
Other intervention name(s): TD-9855
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Symptomatic neurogenic orthostatic hypertension; hepatic impairment
Shanghai Meiji Health Science and Technology Co., Ltd
Condition: Over Weight People
MeSH terms: Overweight
Study type: Interventional

Summary: 
      Investigators performed a randomized double-blind trial to determine the effects of long-term
      NnEx ingestion in patients with overweight or obesity. Ninety-five participants (23<BMI<30
      kg/m2) were randomly allocated to three groups: a control group, a 1 g/day NnEx group, and a
      2 g/day NnEx group. The effects of the consumption of 2 g/day or 1 g/day NnEx for 12 weeks on
      indices of adiposity and fasting blood metabolic parameters were compared with those of no
      consumption of NnEx.
    


Intervention name(s): Nelumbo nucifera Leaf Extract
Intervention type(s): Dietary Supplement
Intervention description(s): Hot water extracted Nelumbo nucifera Leaf, mainly containing quercetin and quercetin 3-O-glucuronide.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Health Services Research
Comparative Study of Pharmacokinetics, Pharmacodynamics, Safety, and Immunogenicity of Single Intravenous Doses of BCD-148 and Soliris®
Condition: Healthy Subjects
Study type: Interventional
Phase: Phase 1

Summary: 
      A Double-blind, Randomized Clinical Study to Compare the Pharmacokinetics, Pharmacodynamics,
      Safety, and Immunogenicity of Single Intravenous Doses of BCD-148 (JSC BIOCAD, Russia) and
      Soliris® in Healthy Volunteers
    


Intervention name(s): BCD-148; Soliris
Intervention type(s): Biological; Biological
Intervention description(s): single intravenous infusion of BCD-148 (900 mg); single intravenous infusion of Soliris (900 mg)
Other intervention name(s): eculizumab; eculizumab
Intervention MeSH terms: Eculizumab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment