bioihbjkbjnl/mcl2 huggingface dataset:
A Study to Evaluate Tolerability and Immunogenicity of V504 Administered Concomitantly With GARDASIL (V504-001)(COMPLETED)
Condition: Cervical Cancer; Vulvar Cancer; Vaginal Cancer; Genital Warts; Human Papillomavirus Infection
MeSH terms: Papillomavirus Infections; Condylomata Acuminata; Vulvar Neoplasms; Vaginal Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate vaccine immunogenicity and how well the body
      tolerates V504 when given with Gardasil.
    


Intervention name(s): V504; Comparator: Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine; Comparator: Placebo (unspecified)
Intervention type(s): Biological; Biological; Biological
Intervention description(s): V504 0.5 ml injection in 3 dose regimen for 6 month treatment period.; Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine 0.5 ml injection in 3 dose regimen for 6 month treatment period.; V504 Placebo in 3 dose regimen for 6 month treatment period.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Autologous Mesenchymal Stem Cells for the Treatment of Neuromyelitis Optica Spectrum Disorders
Condition: Devic's Syndrome; Devic's Neuromyelitis Optica; Devic Syndrome; Devic's Disease; Devic Disease
MeSH terms: Neuromyelitis Optica; Syndrome
Study type: Interventional
Phase: Phase 2

Summary: 
      Neuromyelitis optica (NMO) is a demyelinating and degenerative disorder of the central
      nervous system affecting vision and brain and spinal cord function which leads to
      accumulating disability with a 5 year-mortality of approximately 30%. Survivors are typically
      left with severe morbidity secondary to blindness, quadriparesis and respiratory failure. No
      agent has been found to be highly effective in halting disease activity.Based on recent
      outcomes of Multipotent mesenchymal stromal cells in autoimmune diseases including multiple
      sclerosis, and based on the mechanisms of neuromyelitis optica, the investigators anticipate
      that mesenchymal stem cells transplantation may provide lasting disease stability for
      neuromyelitis optica patients.
    

Detailed description: 
      Primary objective was to assess feasibility and safety; the investigators compared adverse
      events from up to 3months before treatment until up to 12 months after the infusion.

      As a secondary objective, the investigators chose efficacy outcomes to assess the Expanded
      Disability Status (EDSS)、annual relapse rate (ARR) and time to next relapse after transplant.

      Third objective anterior visual pathway and pyramidal tract as a model of wider disease.
      Masked endpoint analyses was used for electrophysiological and selected imaging outcomes.
    

Intervention name(s): Autologous mesenchymal stem cells
Intervention type(s): Biological
Intervention description(s): Autologous mesenchymal stem cells
Other intervention name(s): MSC
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Autologous mesenchymal stem cells; neuromyelitis optica; treatment
Regional Activation of Leukocytes in Coronary Artery Disease
Condition: Inflammation; Coronary Artery Disease
MeSH terms: Coronary Artery Disease; Myocardial Ischemia; Coronary Disease; Inflammation
Study type: Observational

Summary: 
      This study aims to evaluate the role of leukocyte activation in coronary artery disease
    

Detailed description: 
      1. The primary aim of REAL CAD is to determine regional differences of leukocyte activation
           in different vascular beds in vivo.

        2. The secondary aim is to investigate differences in leukocyte activation between diabetic
           and CAD subjects and patients suffering from both.

        3. The third aim is to investigate the relationship between complement components,
           triglycerides and leukocyte activation markers in order to gain more insight into the
           causative processes leading to activation of leukocytes.

        4. The fourth aim is to get more insight in the MBL genotypes and serum levels of CAD
           and/or diabetic patients and the 'healthy' groups included in our study.
    

Observational model: Case-Only
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Patients undergoing coronary angiography
LEO 27847 - Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Study in Secondary Hyperparathyroidism Patients
Condition: Secondary Hyperparathyroidism
MeSH terms: Neoplasm Metastasis; Hyperparathyroidism; Hyperparathyroidism, Secondary
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this trial is to determine the safety and tolerability of ascending single and
      multiple oral doses of LEO 27847 in secondary hyperparathyroidism patients.
    


Intervention name(s): LEO 27847
Intervention type(s): Drug
Intervention description(s): First in patient
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Other
Keywords: Safety and tolerability of LEO 27847
Influence of Lavender Oil on Vital Signs in Oral Surgery Patients
Condition: Dental Anxiety; Sedative; Anxiety Disorder
MeSH terms: Anxiety Disorders
Study type: Interventional

Summary: 
      The aim of this study is to investigate the impact of lavender oil (Lavandula angustifolia)
      on anxiety, mood, vital signs (blood pressure, respiratory rate, heart rate and saturation)
      for oral surgery patients.
    

Detailed description: 
      Lavender oil has sedative properties. Oral surgical procedures have been proven as to be the
      greatest concern among dental practices for patients. Limited randomized clinical trials have
      demonstrated evidence-based results of lavender oil, despite being the most effective
      essential oil for anxiety and stress. The hypothesis of the present study was that the
      inhalation of lavender oil prior to oral surgical procedures may reduce anxiety and
      consequently may effect intra and post-operative blood pressure, inspiration and heart rate.
    

Intervention name(s): Inhalation; Anxiety Questionnaires 1; Anxiety Questionnaires 2; Vital Signs 1; Vital Signs 2; Vital Signs 3; Vital Signs 4
Intervention type(s): Behavioral; Other; Other; Diagnostic Test; Diagnostic Test; Diagnostic Test; Diagnostic Test
Intervention description(s): lavender oil inhalation in a separate room for 3 minutes prior to surgery; Modified Dental Anxiety Scale was used to describe the level of the dental anxiety.; State-Trait Anxiety Inventory-State Scale was used to distinguish the true anxiety level of the patients from the anxiety level for a particular situation.; Changes in vital signs 1 - blood pressure - before, during and after the procedure were noted.; Changes in vital signs 2 - respiratory rate - before, during and after the procedure were noted.; Changes in vital signs 3 - heart rate - before, during and after the procedure were noted.; Changes in vital signs 4 - saturation - before, during and after the procedure were noted.
Other intervention name(s): lavender oil application; Modified Dental Anxiety Scale; State-Trait Anxiety Inventory-State Scale; Blood Pressure; Respiratory rate; Heart rate; Saturation
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: Lavandula; phytotherapy; aromatherapy; dental anxiety; anaesthesia
A Phase IB Dose Escalation Study of Lipocurc in Patients With Cancer
Condition: Patients w/Advanced Cancer That Failed Std of Care Therapy
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This is a single center in patient/outpatient, uncontrolled dose escalating study in cancer
      patients to evaluate the safety, tolerability and pharmacokinetic (PK) profiles of body
      surface area adjusted doses of liposomal curcumin administered intravenously as an 8 hour
      infusion once weekly for 8 weeks.
    

Detailed description: 
      Patients with solid tumors who either failed to initially respond to approved chemotherapy or
      who have progressive solid tumor cancers following initial response to approved chemotherapy,
      are eligible for treatment in this phase 1b trial of ascending doses of intravenous liposomal
      curcumin following a four week period without previous chemotherapy.The escalating dose range
      of liposomal curcumin will be from 100mg/M2 to 300 mg/M2 in cohorts of three to 6 patients,
      and administered over eight hours by a syringe pump weekly for eight weeks. Safety and
      tolerability will be determined by drug related adverse symptoms(if any), hematologic and
      serologic signs at each clinic visit and by electronic communication between visits.
      Pharmacokinetic profiles following infusion of drug will be compared with any adverse
      changes, and any beneficial subjective or objective responses. When the maximum tolerated
      dose level is reached in any cohort , another three patients will be accrued at a preceding
      dose level to assure tolerability in subsequent phase 2 clinical trials.
    

Intervention name(s): Liposomeal curcumin
Intervention type(s): Drug
Intervention MeSH terms: Curcumin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
LEVANT Japan Clinical Trial
Condition: Femoral Arterial Stenosis; Stenosis of Popliteal Arteries; Femoral Artery Occlusion; Occlusion of Popliteal Arteries
MeSH terms: Constriction, Pathologic
Study type: Interventional
Phase: Phase 2

Summary: 
      To demonstrate the safety and efficacy of MD02-LDCB for treatment of stenosis or occlusion of
      the femoral and popliteal arteries in the Japanese population.
    

Detailed description: 
      The study will enroll patients presenting with claudication or ischemic rest pain and an
      angiographically significant lesion in the superficial femoral or popliteal artery and a
      patent outflow artery to the foot. After successful protocol-defined pre-dilatation, subjects
      that are determined not to require stenting based on defined angiographic criteria are
      randomized 2:1 to treatment with either MD02-LDCB (test arm) or standard PTA catheter
      (control arm) using similar techniques. Subjects that do not meet post-predilatation lesion
      criteria are excluded (and treated per standard practice) and followed for safety for 30
      days. Randomized subjects will have ultrasound follow-up through 2 years and are consented
      for up to 2 years clinical follow-up.
    

Intervention name(s): MD02-LDCB Paclitaxel coated balloon catheter; Standard Uncoated Balloon Angioplasty Catheter
Intervention type(s): Device; Procedure
Other intervention name(s): PTA Catheter
Intervention MeSH terms: Paclitaxel
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Arms; Experimental; Drug Coated Angioplasty Balloon; Active Comparator; Standard angioplasty balloon
Gastrointestinal Biopsychosocial Research Center
Condition: Chronic Proctalgia (Also Called Levator Ani Syndrome)
Study type: Interventional

Summary: 
      This study has been completed. The following is a brief description of the aims, methods, and
      results of the study:

      Previous small studies suggest that chronic proctalgia (chronic recurring pain in the anal
      canal or rectum), which is also called levator ani syndrome, can be treated with biofeedback
      to teach relaxation of pelvic floor muscles, or electrogalvanic stimulation (electrical
      stimulation to relax muscles), or massage of pelvic floor muscles. The aim of this study was
      to compare the effectiveness of these three treatments, to determine how they work
      physiologically, and to identify which patients are most likely to benefit.

      Methods: Subjects had to meet the diagnostic criteria for chronic proctalgia and to report
      pain at least once a week. They had to also be free of medical or psychiatric disorders that
      could explain their chronic proctalgia. Patients qualified to enter the study were separated
      into two groups based on whether they reported tenderness when the examining physician
      pressed on the levator ani muscles of the pelvic floor. All 157 patients who were enrolled
      received 9 sessions of psychological counseling plus biofeedback or electrogalvanic
      stimulation or massage. The results of treatment were assessed at 1, 3, 6, and 12 months
      after the end of treatment.
    


Intervention name(s): Biofeedback; Electrogalvanic stimulation; Digital massage
Intervention type(s): Behavioral; Other; Behavioral
Intervention description(s): Electromyographic (EMG) activity was recorded from sensors placed in the anal canal, averaged, and displayed to patients to help them learn to relax the pelvic floor muscles during straining.; Electrical stimulation was applied to pelvic floor muscles through an anal plug. Frequency was 80 pulses per sec, and voltage was slowly increased from 0 to 150-350 volts as tolerated.; Using a gloved finger, the therapist pressed on the levator ani as firmly as tolerated and moved the finger from side to side 3-4 times.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Biofeedback; Pelvic floor; Levator ani syndrome; Chronic proctalgia; Electrogalvanic stimulation; Massage
Qualitative Research on Women With Congenital Adrenal Hyperplasia
Condition: Congenital Adrenal Hyperplasia
MeSH terms: Adrenal Hyperplasia, Congenital; Adrenogenital Syndrome; Adrenocortical Hyperfunction; Hyperplasia
Study type: Observational

Summary: 
      This qualitative interview-based study will investigate the impact that living with
      congenital adrenal hyperplasia has for women in the following areas: health-related quality
      of life (HRQL), psychological health, and health-seeking behaviors.
    

Detailed description: 
      Congenital Adrenal Hyperplasia is a chronic-illness requiring life-long treatment and is
      caused by an inherited enzyme deficiency that leads to an overproduction of hormones produced
      by the adrenal glands, which in turn, masculinizes the female genitalia before birth. While
      the mechanisms by which CAH influences physiological development are understood, the impact
      of this hormonal elevation on health-related quality of life (HRQL), psychological health,
      and health-seeking behaviors is less clear. This study is guided by three research questions:
      (1) how does CAH influence HRQL domains (physical, functional, emotional and
      interpersonally), (2) how does CAH influence the mental health of women diagnosed with CAH,
      and (3) how does CAH influence decisions to seek help from a counselor? Semi-structured
      qualitative interviews will be conducted with women with CAH. Interviews will be analyzed
      through the Consensual Qualitative Research (CQR) methodology.
    

Intervention name(s): Interview
Intervention type(s): Other
Intervention description(s): Hour-long, qualitative, phone interview
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Women diagnosed with CAH (either simple-virilizing or salt-losing types) living in the
        United States
      
Keywords: Adrenal Hyperplasia, Congenital; Psychosexual Development; Sexual Development; Intersex; Qualitative; CAH; Interview; Disorder of Sex Development; Telephone; Quality of Life; Mental Health; Counseling
The Importance of Anti-anaerobic Therapy for Acute Pelvic Inflammatory Disease (PID)
Condition: Pelvic Inflammatory Disease
MeSH terms: Pelvic Inflammatory Disease; Pelvic Infection
Study type: Interventional
Phase: Phase 2

Summary: 
      This study is a randomized placebo-controlled trial comparing two antibiotic treatment
      regimens for acute PID. Women with acute PID will be randomized to one of two treatment
      regimens: 1) a single intramuscular dose of ceftriaxone 250 mg, doxycycline 100 mg orally
      twice a day for 14 days, along with placebo tablets orally twice a day for 14 days or 2) same
      doses of ceftriaxone and doxycycline, and metronidazole 500 mg orally twice a day for 14
      days. The primary objective is to compare the eradication of anaerobic organisms from the
      upper genital tract between women who receive standard outpatient antibiotic treatment to
      those who receive standard outpatient treatment along with a two-week course of
      metronidazole.
    

Detailed description: 
      This study is a randomized placebo-controlled trial comparing two antibiotic treatment
      regimens for acute PID. Women with acute PID will be randomized to one of two treatment
      regimens. One group of women will receive a single intramuscular dose of ceftriaxone 250 mg,
      doxycycline 100 mg orally twice a day for 14 days, along with placebo tablets orally twice a
      day for 14 days. The second group of women will receive the same doses of ceftriaxone and
      doxycycline, and metronidazole 500 mg orally twice a day for 14 days. The primary objective
      is to compare the eradication of anaerobic organisms from the upper genital tract in women
      with acute PID who receive standard outpatient antibiotic treatment to the eradication of
      these organisms from the upper genital tract in women who receive standard outpatient
      treatment along with a two-week course of metronidazole. Women will be followed for one month
      for clinical outcomes, and will undergo assessment for clearance of microorganisms from the
      upper genital tract. Our hypothesis is that an antibiotic treatment regimen that includes
      anaerobic coverage will more effectively clear anaerobic organisms from the endometrium in
      women with acute PID compared to a standard antibiotic treatment regimen lacking effective
      antibiotic coverage against anaerobes.
    

Intervention name(s): Ceftriaxone; Doxycycline; Metronidazole; Placebo Oral Capsule
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): ceftrixone 250mg IM single dose; Doxycycline 100 mg PO bid x 14 days; metronidazole 500 mg PO bid x 14 days; placebo oral capsule PO bid x 14 days
Other intervention name(s): Rocephin; Flagyl
Intervention MeSH terms: Metronidazole; Doxycycline; Ceftriaxone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: PID; Pelvic Inflammatory Disease
Safety and Pharmacokinetics of Intravaginal Rings Containing Vicriviroc (MK-4176) and/or MK-2048
Condition: HIV Infections
MeSH terms: HIV Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      Research is currently underway to develop new HIV prevention strategies. Intravaginal rings
      (IVRs) are one drug delivery method that is currently being studied. This study will evaluate
      the safety and pharmacokinetics of IVRs containing vicriviroc, MK-2048, and a combination of
      vicriviroc/MK-2048, in healthy, HIV-uninfected women.
    

Detailed description: 
      The development of safe and effective HIV prevention strategies is an important global health
      priority. IVRs have previously been approved as a delivery method for various medications,
      and this study will evaluate IVRs containing HIV antiretroviral medications. The purpose of
      this study is to assess the safety and pharmacokinetics of a combination IVR called MK-2048A
      that contains vicriviroc (MK-4176) and MK-2048, compared to IVRs containing vicriviroc alone
      and MK-2048 alone.

      This study will enroll healthy, HIV-uninfected women, 18 to 45 years old. Participants will
      be randomly assigned to receive an IVR containing either vicriviroc, MK-2048, MK-2048A (which
      contains vicriviroc and MK-2048), or placebo. Participants will receive their assigned IVR at
      the enrollment visit, and the IVR will be removed on Day 28. Participants will attend study
      visits at screening, enrollment (Day 0), and Days 1, 2, 3, 7, 14, 21, 28, 29, 30, 31, and 35.
      Study visits may include behavioral assessments, adherence counseling and assessments,
      medical history reviews, physical examinations, urine collection, blood collection, pelvic
      specimen collection, and rectal specimen collection (optional).
    

Intervention name(s): Vicriviroc (MK-4176) Intravaginal Ring (IVR); MK-2048 IVR; MK-2048A IVR; Placebo IVR
Intervention type(s): Device; Device; Device; Device
Intervention description(s): Contains 182 mg vicriviroc (MK-4176).; Contains 30 mg MK-2048.; Contains 182 mg vicriviroc (MK-4176) and 30 mg MK-2048.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Bioequivalence Study of Fenofibrate Capsules, 130 mg Under Fasting Conditions
Condition: Healthy
Study type: Interventional

Summary: 
      The study was conducted as an open label, balanced, randomized, two-treatment, two-period,
      two-sequence, crossover bioequivalence study comparing a single oral dose of fenofibrate
      capsules, USP 130 mg, of Ohm Laboratories Inc. USA (a subsidiary of Ranbaxy Pharmaceutical
      Inc.) with Antara® (fenofibrate) Capsules 130 mg of Oscient Pharmaceuticals Corporation USA,
      in healthy, adult, male, human subjects under fasting condition.
    

Detailed description: 
      The subjects were subjected to breath test for alcohol and test for drugs of abuse (opioids
      and cannabinoids) in urine prior to admission in each period.

      All subjects fasted overnight for at least 10 hours before the morning dose and for 4 hours
      post-dose during each period of the study. A single oral dose of either test (T) or reference
      (R) was administered with 240 mL of drinking water at ambient temperature under supervision
      of trained study personnel. Both test and reference products were administered to all the
      study subjects, one in each period (except subject numbers 17, 27 and 42).

      Blood samples were collected at Predose (duplicate) and at 1.000, 2.000, 2.500, 3.000, 3.500,
      4.000, 4.500, 5.000, 5.500, 6.000, 6.500, 7.000, 7.500, 8.000, 8.500, 9.000, 10.000, 11.000,
      12.000, 16.000, 24.000, 36.000, 48.000, 72.000 and 96.000 hours post dose, in pre-chilled
      vacutainers, under low light condition, in each period from all completed subjects. The
      pre-dose blood samples in each period were collected in duplicate (2 x 5 mL), within a period
      of 1.5 hour before dosing.

      The actual end time of collection of each blood sample was recorded. During the course of the
      study, safety parameters assessed were vital signs, clinical examination, medical history and
      clinical laboratory safety tests (hematology, biochemical parameters, serology and urine
      analysis at screening). Adverse event monitoring was done throughout the study. Laboratory
      parameters of hematology and biochemistry were repeated at the end of the study.
    

Intervention name(s): Fenofibrate; ANTARA® (fenofibrate)
Intervention type(s): Drug; Drug
Intervention description(s): 130mg Capsules; 130mg Capsules
Intervention MeSH terms: Fenofibrate
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)