bioihbjkbjnl/mcl2 huggingface dataset:
Phase 1b Maintenance Therapy Study of ONT-10 in Patients With Solid Tumors
Condition: Solid Tumors
Study type: Interventional
Phase: Phase 1

Summary: 
      This is an open label phase 1b maintenance therapy study to evaluate the long-term safety,
      immunogenicity, and anti-tumor effects of repeat-dose vaccination with ONT-10 in patients who
      have demonstrated safety and clinical benefit on the original ONT-10-001 phase 1 study.
    

Detailed description: 
      Open label Phase 1b maintenance therapy study to evaluate the long-term safety,
      immunogenicity, and anti-tumor effects of repeat-dose vaccination with ONT-10 in patients
      with previously treated Stage 3 or 4 solid tumors with histologies that have been associated
      with expression of the MUC1 antigen as described in the medical literature. Patients must
      have previously been enrolled on the Phase 1 clinical trial ONT-10-001, completed all
      treatment and follow-up through at least 12 weeks, experienced no dose limiting toxicity, and
      experienced no progression of disease per the immune-related Response Criteria. Patients will
      receive maintenance ONT-10 every 6 weeks.
    

Intervention name(s): ONT-10
Intervention type(s): Biological
Intervention description(s): ONT-10 is a liposomal synthetic glycopolypeptide antigen formulated with PET Lipid A adjuvant
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: ONT-10; MUC1; Vaccine; Phase 1b; Solid tumors; Maintenance therapy
Long-Acting Tacrolimus for the Treatment of Resistant Lupus Nephritis
Condition: Lupus Nephritis
MeSH terms: Nephritis; Lupus Nephritis
Study type: Interventional
Phase: Phase 4

Summary: 
      Glomerulonephritis is one of the major disease manifestations of systemic lupus erythematosus
      (SLE). Around one-third of the patients, however, do not respond to conventional
      immunosuppressive therapy, and they have a high risk of progressing to dialysis-dependent
      renal failure. Recent studies suggest that immunosuppressive therapy targeted against the
      calcineurin pathway of T-helper cell, for example, tacrolimus, may be effective in the
      treatment of primary glomerulonephritis. The investigators plan to an open-label single-arm
      study the efficacy and safety of long-acting tacrolimus in the treatment of
      treatment-resistant lupus nephritis. Twenty-five patients with biopsy-proven lupus nephritis
      will be recruited. They will be treated with oral prednisolone and long-acting tacrolimus for
      6 months, followed by 6 months of maintenance steroid and azathioprine. Proteinuria, renal
      function, clinical and serologic lupus activity will be monitored. This study will explore
      the potential role of long-acting tacrolimus in resistant lupus nephritis, which has a poor
      prognosis and no effective treatment at the moment.
    


Intervention name(s): Long-acting tacrolimus (Advagraf, Astellas Pharma)
Intervention type(s): Drug
Intervention description(s): Long-acting tacrolimus (Advagraf, Astellas Pharma) will be started at single daily dose of 0.15-0.2 mg/kg/day for 6 months.
Intervention MeSH terms: Tacrolimus
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: glomerulonephritis; systemic lupus erythematosus
Effects of tDCS on High Level and Recreational Athletes
Condition: Healthy; Athlete
Study type: Interventional

Summary: 
      Healthy recreational and high level athletes will undergo 2 randomized, cross-over
      counterbalanced sessions of anodal tDCS or sham tDCS.

      The primary outcome is an isokinetic evaluation of their hamstrings' and quadriceps'
      endurance after each session
    

Detailed description: 
      Recruitment :

      Healthy recreational and high level athletes will be recruited through social media and
      advertisements.

      Each subject came twice to the Liege University Hospitals' isokinetic lab. Each session began
      with strapping the subjet into the isokinetic machine, making sure that all the settings were
      adapted to the subject. Then, each subject received either anodal tDCS, of sham tDCS. Neither
      the evaluator or the subject knew which they were receiving. Immediately following tDCS,
      there was a warmup consisting of stationary bike, and an isokinetic warmup. Then, subjects'
      endurance was using a maximal isokinetic tests, at 30 maximal concentric and eccentric
      contractions at a speed of 180°/s.
    

Intervention name(s): tDCS
Intervention type(s): Device
Intervention description(s): 20 minutes of anodal tDCS (C3/FP2) 2mA or sham
Other intervention name(s): Non invasive brain stimulation
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Randomized, triple-blind, sham-controlled, crossover
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Health Services Research
Keywords: tDCS; Athlete; Isokinetic; Endurance; Fatigue
LH Hormone Pulsation in the Luteal Phase in GnRH Antagonist IVF Cycles Triggered by GnRH Agonist for Final Oocyte Maturation
Condition: Infertility
MeSH terms: Infertility
Study type: Observational

Summary: 
      Monitoring the LH pulsatility during the Luteal phase in GnRH antagonist IVF cycles triggered
      by GnRH agonist for final oocyte maturation.
    

Detailed description: 
      About two decades ago the GnRH antagonist has been used in IVF cycles to prevent premature LH
      surge. In recent review GNRH antagonist has been found comparable to GnRH agonist in term of
      live birth rate but with reduced risk of OHSS. another advantage of using GnRH antagonist is
      the ability to use GnRH agonist for final oocyte maturation which has been shown to nearly
      eliminate the risk of OHSS. The exact mechanism of this risk reduction is still unknown.

      Our aim is to do a frequent blood tests every 20 minutes for 6 hours duration in the day of
      ovum pick up or the day of embryo transfer to measure the level of LH, estradiol and
      progesterone in women triggered with GnRH agonist for final oocyte maturation.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        women aged 18-42 years old BMI < 32 kg/M2
      
Biospecimen description: 
      frequent blood tests for luteinizing hormone, estradil and progesterone levels
    
Keywords: luteinizing hormone pulsatility; estradiol level; progesterone level
Evaluation of Gut Absorption Rate of Glucose After a Large Evening Meal in Type 1 Diabetes
Condition: Type 1 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Observational

Summary: 
      Eight adolescent and young adult subjects with type 1 diabetes, age 16-24 years, will be
      recruited for this study on the basis of informed consent. Participants will be invited to
      attend the Wellcome Trust Clinical Research Facility at Addenbrooke's Hospital, Cambridge, on
      two occasions. On each occasion participants will arrive at the unit at 9am having controlled
      their diabetes with short acting insulin for 24 hours and they will remain in the unit until
      8am the next morning. During the day, between 9am and 6pm participants will remain fasting
      and their blood glucose levels will be controlled by intravenous insulin, the dose being
      determined by 15-30 minute blood glucose estimations. At 1800hr on visit 1 the subjects will
      be asked to ingest an evening meal enriched by a cold isotope glucose tracer (non
      radioactive). The variable insulin infusion will be adjusted to allow for the meal in order
      to achieve good glycaemic control after the meal until 0200hr. From then until 0800hr in the
      morning the study team will again adjust the infusion rates to maintain normal glycemia until
      the participants are ready to go home on their normal insulin regimen. On the second visit
      the protocol will be identical until 1800hr when instead of giving the meal variable amounts
      of glucose will be infused to ensure the glucose levels are identical to those observed on
      visit 1. After 0200hr the study will be effectively finished but the study team will continue
      to vary the insulin infusion to keep blood glucose levels normal until the subjects can go
      home on their normal insulin regime at 8am.

      In order to achieve sufficient information to make all the calculations needed other cold
      isotope glucose tracers will be infused during the study period. These safe non radioactive
      isotope tracers will enable us to assess glucose being produced by the body, its distribution
      and utilization. Throughout both study periods the subjects will be monitored very closely by
      a Clinical Research Fellow, assisted by a Research Nurse, in order to avoid any risk of low
      blood glucose levels.
    


Sampling method: Non-Probability Sample
Study population: 
        Young adults with type 1 diabetes
The Effectiveness of Radial ESWT on Upper Trapezius Mtrps
Condition: Myofascial Pain Syndrome; Myofascial Trigger Point Pain; Upper Trapezius Trigger Points
MeSH terms: Myofascial Pain Syndromes; Fibromyalgia
Study type: Interventional

Summary: 
      This study looked after the effectiveness of radial ESWT on upper trapezius mtrps. There were
      three intervention groups which recieved either ESWT or standard care. VAS, PPT, Neck ROM and
      Cervical functionality were the main outcomes.
    

Detailed description: 
      This study was a randomized controlled trial consisted of three intervention groups. Two of
      them recieved ESWT with different parameters in each group, while the third one was standard
      care recieving Ultrasound therapy, Therapeutic massage and Heat packs Participants were
      divided randomly into the three groups. Participants were blind to the group allocated and
      also the therapist and outcome investigator were blind.

      The participants recieved three weekly sessions. The evaluation took place before therapy,
      after each session and one month after last session.

      The outcome measures was the pain intensity with VAS, the pain tolerance to pressure by an
      algometer device, the range of motion of neck measured by electronic goniometer and and
      functionality of neck measured by the Northwick Park Neck Pain
    

Intervention name(s): Extracorporeal Shockwave Therapy; Extracorporeal Shockwave Therapy; Ultrasound therapy, Massage, Heat pack
Intervention type(s): Device; Device; Device
Intervention description(s): 1000 pulses at 60 mj, 10 Hz; 2000 pulses at 60 mj, 10 Hz; Ultrasound therapy 5 min, 1,2W/cm2, 10 min Massage, 10 min heat pack
Other intervention name(s): ESWT; rSWT
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Myofascial Trigger points; upper trapezius; Myofascial pain syndrome; Mtrps
A 4 Week Study to Investigate the Safety and Tolerability of AZD5069 in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)
Condition: Scientific Terminology Chronic Obstructive Pulmonary Disease (COPD); Laymen Terminology Chronic Bronchitis and Emphysema
MeSH terms: Bronchitis; Bronchitis, Chronic; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Emphysema
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is the evaluate the safety and tolerability of AZD5069 in patients
      with Chronic Obstructive Pulmonary Disease
    


Intervention name(s): Placebo; AZD5069 50mg; AZD5069 80mg
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Oral dose bid; Oral dose bid; Oral dose bid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Chronic Obstructive Pulmonary Disease, Neutrophil, Respiratory Disease
Dose Finding Evaluation of Kudzu Root Extract in Women With Menopause Symptoms
Condition: Menopause
Study type: Interventional

Summary: 
      The aim of the study is to investigate effects of daily intake of Nordic Kudzu for 28 days in
      5 groups of 10 menopausal women with symptoms. Groups:1) 3 capsules x3/day, 2) 3 capsules
      x2/day, 3) 2 capsules x3/day, 4) 2 capsules x2/day, 5) 3 capsules x1/day. Each capsule equal
      1.26 g kudzu root extract. Outcome measures: Serum and urine levels of biochemical marker of
      bone-degradation, CTX-I, and symptoms of menopause using the Meopause Rating Scale (MRS).
    


Intervention name(s): 3 caps x3/day; 3 caps x2/day; 2 caps x3/day; 2 caps x2/day; 3 caps x1/day
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): 3 capsules 3 times daily for 28 days; 3 capsules 2 times daily for 28 days; 2 capsules 3 times daily for 28 days; 2 capsules 2 times daily for 28 days; 3 capsules 1 times daily for 28 days
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Unblinded, single-center, randomized, exploratory, dose-finding study. 1:1:1:1:1 randomisation to 5 groups of different doses for 28 days.
Masking: None (Open Label)
Primary purpose: Treatment
Safety and Efficacy of Asacol 4.8 g/Day Versus Asacol 2.4 g/Day (ASCEND I)
Condition: Ulcerative Colitis
MeSH terms: Colitis; Colitis, Ulcerative; Ulcer
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate the safety and efficacy of Asacol 4.8 g/day (800 mg
      tablet) versus Asacol 2.4 g/day (400 mg tablet
    

Detailed description: 
      This study is designed to evaluate the safety and efficacy of 4.8 g/day using 800 mg Asacol
      tablets as compared to 2.4g/day using 400 mg Asacol tablets in newly- and
      previously-diagnosed patients who are experiencing a flare-up of mildly to moderately active
      ulcerative colitis.
    

Intervention name(s): mesalamine; mesalamine
Intervention type(s): Drug; Drug
Intervention description(s): mesalamine 2.4 g/day (400 mg tablet) for 6 weeks; mesalamine 4.8 g/day (800 mg tablet) for 6 weeks
Intervention MeSH terms: Mesalamine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
A Randomized, Double-Blind, Placebo-Controlled, Sequential Parallel Study of CERC-301 in the Adjunctive Treatment of Subjects With Severe Depression and Recent Active Suicidal Ideation Despite Antidepressant Treatment
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depressive Disorder, Major; Suicidal Ideation
Study type: Interventional
Phase: Phase 2

Summary: 
      The current study will evaluate the antidepressant effect of CERC-301 during 28 days of
      treatment in subjects with MDD who are currently experiencing a severe depressive episode
      despite stable ongoing treatment with selective serotonin- or serotonin-norepinephrine
      reuptake inhibitors (SSRI or SNRI). The study population will be enriched for subjects that
      would benefit most from rapid onset, those with recent active suicidal ideation, but not a
      risk to themselves or others and are deemed appropriate for an out-patient study with careful
      safety surveillance. This will allow the study to focus on the antidepressant effects of
      CERC-301 but also explore effects on suicidal ideation. To explore rapid onset, the primary
      endpoint will be at 7 days, but effects over the 28 days of treatment will be examined as a
      secondary endpoint.
    


Intervention name(s): CERC-301; Placebo
Intervention type(s): Drug; Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Intrauterine G-CSF Administration in RIF
Condition: Infertility
MeSH terms: Infertility
Study type: Interventional

Summary: 
      Aim of this study is to investigate the effects of intrauterine G-CSF on endometrial
      thickness, clinical pregnancy rate and live birth rate in a recurrent implantation failure
      (RIF) group
    

Detailed description: 
      This study was designed as a prospective randomized controlled trial with the involvement of
      200 RIF group patients.The procedure will perform by administering 30 mIU of
      Leucostim®(Filgrastim [G-CSF] 30mIU/mL; DEM Medical, Dong-A; South Korea) through slow
      infusion into the endometrial cavity using a soft embryo transfer catheter. Normal saline of
      1 mL will be infused into the endometrial cavity in the same way in the control group. The
      standard ICSI procedure will use for all patients, and fresh cycle embryos will be
      transferred on the third or fifth day.
    

Intervention name(s): G-CSF; Saline
Intervention type(s): Drug; Other
Intervention description(s): Slow infusion of G-CSF into the endometrial cavity using a soft embryo transfer catheter.; Slow infusion of saline into the endometrial cavity using a soft embryo transfer catheter.
Other intervention name(s): Leucostim
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Endometrium; G-CSF; Recurrent implantation failure
Ablation of Ventricular Fibrillation by Accurate Targeting of Arrhythmogenic Regions (AVATAR)
Condition: Ventricular Tachyarrhythmias
MeSH terms: Ventricular Fibrillation; Tachycardia; Tachycardia, Ventricular
Study type: Observational

Summary: 
      This study will test the hypothesis that many human heart rhythm disorders are caused by
      small localized sources, where brief ablation may successfully eliminate the heart rhythm
      disorder.
    

Detailed description: 
      The investigators will enroll patients with documented rapid heart rates from the bottom
      chambers of the heart (ventricular tachyarrhythmias).

      During electrophysiological study, the investigators will map the localized sources of these
      heart rhythm disorders.

        1. The 'active' group will prospectively receive brief ablation at localized sources (Focal
           Impulse and Rotor Modulation, FIRM).

        2. The control group will be a historical cohort who have received traditional ablation for
           this disorder.

      All patients will be followed for up to 1 year to ensure that they have no recurrent
      arrhythmias.
    

Observational model: Case-Control
Time perspective: Other
Sampling method: Probability Sample
Study population: 
        Patients with documented rapid heart rhythms involving the bottom chambers of the heart.
      
Keywords: Ventricular Tachyarrhythmia; Ablation; Electrophysiology; Human; Mapping
Induction Hypotension in Pediatric Population
Condition: Pediatric Surgical Patients
Study type: Observational

Summary: 
      This is a retrospective chart review to assess the incidence and the degree of blood pressure
      changes after induction of anesthesia and to study the effect of different induction agents
      on blood pressure.
    


Intervention name(s): Surgery
Intervention type(s): Procedure
Intervention description(s): All surgeries performed at Nationwide Children's Hosp. between 1/1/2013 & 7/31/2013.
--------------------------------------------------------------------------------
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Surgical patients from Nationwide Children's Hosp.
Rifaximin Modify the Pathogenesis of Non-Alcoholic Fatty Liver Disease (NAFLD)
Condition: Non-alcoholic Fatty Liver Disease
MeSH terms: Liver Diseases; Fatty Liver; Non-alcoholic Fatty Liver Disease
Study type: Observational

Summary: 
      In this multicentric, double-blind, randomized,placebo-controlled study, the investigators
      hypothesized that rifaximin might act on Gram-negative bacteria and intestinal bacterial
      overgrowth(IBO) thereby inhibiting lipopolysaccharides(LPS)-mediated proinflammatory cytokine
      production. This work evaluates the efficacy of 6 months administration of rifaximin in NAFLD
      patients.
    

Detailed description: 
      The investigators aimed to study the effect of rifaximin on NASH. 50 patients with
      biopsy-proven NASH were enrolled in this double-blind, randomized,placebo-controlled study.
      BMI, AST, ALT, gamma glutamyl transferase (γ-GGT), lipid profile, homeostatic model
      assessment (HOMA), serum endotoxin, Toll-like receptor 4 (TlR4), interleukin-6 (IL-6), IL-10,
      tumor necrosis factor-α (TNF-α) and cytokeratin-18 (CK-18) levels were measured before and
      after a 6 month administration of rifaximin (1100mg/day, 550 mg tablets 1 × 2 before meals).
    

Intervention name(s): Rifaximin group 1
Intervention type(s): Drug
Intervention description(s): Rifaximin: 1100mg/day, 550 mg tablets 1 × 2 before meals
Intervention MeSH terms: Rifaximin
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        In this multicentric, double-blind, randomized,placebo-controlled study, we enrolled
        consecutively 1072 participants with hepatitis irrespective to their etiologies referred to
        the Tropical Medicine and Internal Medicine Departments (Mansoura University), Tropical
        Medicine Department (Zagazig University), and Internal Medicine and Endemic Diseases and
        Gastroenterology Departments (Aswan University)from May 2012 to October 2016. All
        participants underwent to the following appraisal: physical and biochemical examination,
        complete history taking, abdominal ultrasound, and percutaneous ultrasound liver biopsy.
      
Keywords: NAFLD; Rifaximin; Endotoxin and Homeostatic Model Assessment
FX-322 in Adults With Stable Sensorineural Hearing Loss
Condition: Sensorineural Hearing Loss; Noise Induced Hearing Loss; Sudden Sensorineural Hearing Loss
MeSH terms: Hearing Loss; Deafness; Hearing Loss, Sensorineural; Hearing Loss, Noise-Induced
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a phase 2a single and repeat dose exploratory efficacy study of intratympanic FX-322
      compared to placebo in healthy male and female adults with stable sensorineural hearing loss.
    

Detailed description: 
      Sensorineural hearing loss (SNHL) accounts for about 90% of all cases of hearing loss. This
      phase 2a study will assess the exploratory efficacy, as well as the local and systemic safety
      of single and repeat intratympanic doses of FX-322 compared to placebo in approximately 96
      subjects with stable mild to moderately severe sensorineural hearing loss, with a medical
      history consistent with either excessive noise exposure or idiopathic sudden sensorineural
      hearing loss.
    

Intervention name(s): FX-322 (One Dose); FX-322 (Two Doses); FX-322 (Four Doses); Placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Patients will receive one dose of FX-322.; Patients will receive two doses of FX-322.; Patients will receive four doses of FX-322.; Patients will receive Placebo.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Intratympanic Administration; Restoration of Hearing Function