bioihbjkbjnl/mcl2 huggingface dataset:
Wireless, Implantable Tibial Nerve Stimulator System for the Treatment of Refractory Lower Urinary Tract Symptoms in Patients With Multiple Sclerosis
Condition: Multiple Sclerosis, Relapsing-Remitting
MeSH terms: Multiple Sclerosis; Multiple Sclerosis, Relapsing-Remitting; Sclerosis; Lower Urinary Tract Symptoms
Study type: Interventional

Summary: 
      Prevalence of lower urinary tract symptoms (LUTS) in patients with multiple sclerosis (MS)
      increases with disease duration. Current management of urinary clinical symptoms in MS is
      mainly conservative. Its long-term outcome is often poor because of the progressive disease
      course and the treatment related side effects. Alternative therapeutic options are botulinum
      toxin injections, electrical stimulation of dorsal penile/clitoral nerve, and sacral nerve
      modulation. Posterior tibial nerve stimulation (PTNS) is a second minimally invasive method
      of electrical stimulation. Multiple benefits may derive from the development and validation
      of a dedicated protocol of a new self-activated neuromodulation therapy, which may improve
      therapy compliance/effectiveness, quality of life and social life in MS patients with
      refractory LUTS. Furthermore, it may contribute to reduce outpatient visits, health costs and
      work absenteeism.
    


Intervention name(s): StimRouter®, Self-activated and self-controlled neuromodulation device (Bioness Inc, CE0086).
Intervention type(s): Device
Intervention description(s): Regimen 1 (weeks 0-12): one stimulation every 2 days, for a duration of 30 minutes each.
Regimen 2 (weeks 12-24): Three stimulation treatments per week, for a duration of 30 minutes each.
Intervention model: Single Group Assignment
Intervention model description: Prospective, interventional, single center
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: overactive bladder; posterior tibial nerve stimulation; lower urinary tract symptoms
Peg-Granulocyte-Colony Stimulating Factor (GCSF) for Coronary Collateral Growth in Coronary Artery Disease Patients
Condition: Coronary Artery Disease
MeSH terms: Coronary Artery Disease; Myocardial Ischemia; Coronary Disease
Study type: Interventional

Summary: 
      The purpose of this study in patients with stable coronary artery disease (CAD) treatable by
      PCI (percutaneous coronary intervention) is to evaluate the long-term efficacy and safety of
      subcutaneously applied, pegylated granulocyte colony stimulating factor (Pegfilgrastim,
      PEG-G-CSF; Neulasta®, Amgen Switzerland) with regard to the promotion of collateral growth.
    

Detailed description: 
      Coronary artery disease (CAD) is the leading cause of death in industrialized countries.
      Current revascularization therapies are PCI or surgical revascularization. However, inherent
      to them are procedure-related risks and the fact, that progression of CAD is not prevented.
      Additionally, up to one fourth of all CAD patients are not amenable to standard
      revascularization therapies. Thus, there is a need for alternative therapies. The coronary
      collateral circulation is prevalent in humans, and in CAD the amount of collateral flow is a
      pivotal protective factor with respect to infarct size, all-cause- and cardiac mortality.
      Coronary collateral growth promotion is an alternative to conventional revascularization
      which can be achieved by cytokine-based approaches (e.g. with colony-stimulating
      factor-therapy) in humans. The goal of collateral promotion is to reduce myocardial damage in
      case of a coronary occlusion.
    

Intervention name(s): pegfilgrastim; Placebo
Intervention type(s): Biological; Other
Intervention description(s): s.c. administration of pegylated G-CSF over 6 months; Placebo control Arm 1: Collateral promotion; PCI after 6 months
Other intervention name(s): Peg-GCSF; Peg-G-CSF; PEG-rmetHuG-CSF; Amgen brand of pegfilgrastim; Neulasta; pegylated (r-G-CSF); Placebo control
Intervention MeSH terms: Lenograstim
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Coronary Artery Disease; Stable; Coronary Collaterals; Therapeutic Collateral Promotion (TCP)
Quality Control Study of Laparoscopic Sentinel Node Biopsy in Early Gastric Cancer
Condition: Early Gastric Cancer
MeSH terms: Stomach Neoplasms
Study type: Interventional

Summary: 
      Laparoscopic sentinel lymph node biopsy and stomach preserving surgery in ealry gastric
      cancer is less invasive method which can increase quality of life. Multicenter phase III
      trial is requred to validate this method. In this study all items which are necessary for
      laparoscopic sentinel lymph node biopsy are identified according to checklist and evaluated
      the performance completement.
    


Intervention name(s): Laparoscopic sentinel lymph node biopsy
Intervention type(s): Procedure
Intervention description(s): During the operation, endoscopic marking was perfomed using Tc 99m HSA and indocyanine green around tumor. Then we identify the sentinel lymph node with laparoscopic probe. Laparoscopic sentinel lymph nodes were dissedted and evaluated them at the backtable in the operating room.
Other intervention name(s): Tc 99m HSA (Frosstimage); indocyanine green (IC-GREEN™ (Akorn)); laparoscopic probe (neoprobe® GDS gamma detection system)
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: laparoscopic sentinel lymph node biopsy; quality control study; early gastric cancer
A Study of Cariprazine in Patients With Chronic Stable Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 2

Summary: 
      This is an outpatient study to evaluate the long-term safety, tolerability, and
      pharmacokinetics of cariprazine in patients with schizophrenia.
    


Intervention name(s): Cariprazine
Intervention type(s): Drug
Intervention description(s): Cariprazine was supplied in capsules.
Other intervention name(s): RGH-188
Intervention MeSH terms: Cariprazine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Improving Medication-taking After Liver Transplant
Condition: Nonadherence; Tacrolimus; Pediatric Liver Transplant Recipients
Study type: Interventional
Phase: Phase 1

Summary: 
      The specific aim is to pilot-test our developed intervention manual's ability to improve
      patients' adherence to medications and medical outcomes (rejection rate, liver enzyme levels)
      in participating centers.
    

Detailed description: 
      Nonadherence (not taking the medications as prescribed) is the most common cause of late
      acute rejection in children who have had a liver transplant, and thus is associated with
      graft loss, increased expenditures on care, and ultimately death. Researchers in this
      application developed a biomarker to identify nonadherence, calculating the standard
      deviation (SD) of consecutive immunosuppressant blood levels for each patient to capture the
      degree of variability between individual levels (higher SD = less consistent levels). By
      applying a threshold, this marker identifies nonadherent patients. A consortium of transplant
      centers is currently testing this marker through the MALT (Medication Adherence in children
      who had a Liver Transplant) study. MALT investigators now propose to take advantage of this
      existing collaboration to pilot-test an intervention to improve adherence in patients who are
      identified by this marker.
    

Intervention name(s): Telemetric
Intervention type(s): Behavioral
Intervention description(s): A manualized behavioral management approach focusing on avoidance and addressing barriers to adherence, delivered via telephone or internet chat applications.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: adherence; nonadherence; compliance; noncompliance; liver transplantation
Clinical Effect, Safety and Tolerability of GSK1070806 in Atopic Dermatitis
Condition: Dermatitis, Atopic
MeSH terms: Dermatitis, Atopic; Dermatitis
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will evaluate efficacy and safety of GSK1070806 in moderate to severe atopic
      dermatitis (AtD) participants.
    


Intervention name(s): GSK1070806; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): GSK1070806 will be administered; Placebo will be administered
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Eczema activity severity index; GSK1070806
Anti-Angiogenic Therapy Post Transplant (ASCR) for Pediatric Solid Tumors
Condition: Glioma; Neuroectodermal Tumors, Primitive; Wilms Tumor; Rhabdomyosarcoma; Sarcoma, Ewing; Osteosarcoma; Retinoblastoma
MeSH terms: Neoplasms; Osteosarcoma; Rhabdomyosarcoma; Neuroectodermal Tumors; Neuroectodermal Tumors, Primitive; Wilms Tumor; Retinoblastoma; Sarcoma, Ewing; Neuroectodermal Tumors, Primitive, Peripheral
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this research study is to determine whether taking either of two low dose
      drugs that would prevent new blood vessels from growing after stem cell transplant is
      feasible, and what the side effects of taking each of these drugs after autologous transplant
      might be. The reason the investigators are looking at these drugs is because one of the
      things that allows tumors to grow quickly is their ability to stimulate the growth of new
      blood vessels. By suppressing the growth of new blood vessels after stem cell transplant, the
      investigators hope to prevent the tumors from coming back or continuing to grow.
    


Intervention name(s): Metronomic Cyclophosphamide; Thalidomide
Intervention type(s): Drug; Drug
Other intervention name(s): Cytoxan®; CPM; Thalomid®
Intervention MeSH terms: Thalidomide; Cyclophosphamide
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Glioma includes ependymoma and medulloblastoma
A Multi-cohort Study of the Tolerance, Safety, and Pharmacokinetics of GNR-055 in Healthy Volunteers
Condition: Mucopolysaccharidosis Type II; Metabolic Diseases
MeSH terms: Mucopolysaccharidosis II; Mucopolysaccharidoses; Metabolic Diseases
Study type: Interventional
Phase: Phase 1

Summary: 
      It is a phase I open-label single-dose, dose-escalation cohort study to evaluate of the
      tolerance, safety, and pharmacokinetics of GNR-055 in healthy volunteers
    

Detailed description: 
      GNR-055 is intended for ERT in patient with Mucopolysaccharidosis type II (MPS II), or Hunter
      syndrome. MPS II is a lysosomal storage disease with an X-linked recessive inheritance type,
      which is characterized by a decrease in the activity of the lysosomal enzyme
      iduronate-2-sulfatase (I2S), caused by a mutation in the IDS gene. Enzyme deficiency leads to
      the accumulation of glycosaminoglycans (GAG) in lysosomes, mainly fractions of heparan and
      dermatan sulfates. Because of the insufficient activity of iduronate sulfatase participating
      in the first stage of catabolism of GAG, they accumulate in lysosomes of almost all types of
      cells of various tissues and organs. The disease is manifested by growth retardation, damage
      of many organs and systems, severe deformations of bones and joints, gross facial features,
      pathology of the respiratory and cardiovascular systems, damage to parenchymal organs
      (hepatosplenomegaly), and hearing impairment. A severe form of the disease occurs with the
      involvement of the nervous system in the pathological process, including mental retardation,
      behavior anomalies, and impaired motor function.

      GNR 055 is a modified enzyme iduronate-2-sulfatase capable of penetrating the blood-brain
      barrier and thus it is expected to prevent neurodegenerative consequences and the development
      of cognitive deficit in the future that will allow achieving a significant improvement in the
      life quality and expectancy of patients with MPS II
    

Intervention name(s): GNR-055
Intervention type(s): Biological
Intervention description(s): Single intravenous administration
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Mucopolysaccharidosis type II; Mucopolysaccharidoses; Metabolic Diseases; Lysosomal Storage Diseases; Carbohydrate Metabolism, Inborn; Metabolism, Inborn; Genetic Diseases, Inborn; Neurobehavioral Manifestations; Neurologic Manifestations; Genetic Diseases, X-Linked
Study to Evaluate the Effects of Itraconazole and Rifampin on the Pharmacokinetics of ASC40 in Healthy Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective of this study is to evaluate the effects of itraconazole (a strong
      inhibitor of cytochrome P450 3A (CYP3A)) and rifampicin (a strong inducer of CYP3A) on the
      pharmacokinetics of ASC40 in healthy volunteers.
    


Intervention name(s): ASC40; Itraconazole; rifampicin
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Oral tablets; Oral capsules; Oral capsules
Intervention MeSH terms: Itraconazole; Rifampin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Healthy Volunteers; DDI (Drug-Drug Interaction); Itraconazole; Rifampicin; ASC40
Phase 2 Study on Use of a Combination of Pemetrexed in Patients With Advanced Gastric Carcinoma
Condition: Gastrointestinal Neoplasms
MeSH terms: Stomach Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      Pemetrexed has shown an anti-tumor activity in advanced gastric cancer patients in a previous
      study, while cisplatin is widely used in the combination chemotherapy of gastric cancer.
      Pemetrexed has shown synergy with cisplatin in preclinical models and in various human
      cancers. The introduction of vitamin supplementation has made treatment with pemetrexed plus
      cisplatin safe and well tolerated. The present phase 2 study is an effort to determine the
      efficacy and safety of the combination of pemetrexed and cisplatin in Korean patients with
      gastric carcinoma who had no prior palliative chemotherapy for advanced disease. The
      patients, who will give their consent for participating in this study, will be screened for
      their eligibility and on meeting pre-defined study eligibility criteria, they will receive an
      intravenous therapy of the combination of pemetrexed and cisplatin for number of times that
      in the opinion of their treating physician is appropriate for them. A response rate of 30% is
      considered as the minimum activity level of interest for this patient population.
    


Intervention name(s): pemetrexed; cisplatin
Intervention type(s): Drug; Drug
Intervention MeSH terms: Pemetrexed
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Labour Pain is a Subjective Experience. The Degree of a Woman's Suffering in Childbirth Depends on Indirect Factors
Condition: Pain, Labor
MeSH terms: Labor Pain
Study type: Observational

Summary: 
      Pain During Childbirth is a Complex and Subjective Experience. The Degree of a Woman's
      Suffering in Childbirth Depends on the Intensity of Labour Pain and Many Indirect Factors.
      Complex Interrelated Effects on Labour Pain Are Limited by the Little Number of Studies
      Available. That is Why it is Necessary to Determine the Probable Factors That May Affect the
      Intensity of Pain.
    

Detailed description: 
      A prospective observational study was conducted in the period from December 2020 to May 2021
      at the Kyiv City Maternity Hospital №5 (Kyiv, Ukraine). The study protocol was approved by
      the Bogomolets National Medical University Ethics Committee. The examined predictors were
      derived from mothers' self-report of overall childbirth. 366 women took part in research, 282
      of participants rated their pain by ≤ 60 mm visual analog scale (VAS), while 84 patients
      reported their pain by ≥70 mm VAS. The aim of study was to investigate predictors of severe
      labour pain. In the postpartum period all patients filled questionnaires and underwent
      interviews from the 1st to the 3rd day after delivery. The following groups of risk factors
      were studied:

        1. Demographic indicators (age, level of working capacity 2 months before childbirth,
           attendance of maternity school).

        2. General level of health (woman's level of health before childbirth, daily physical
           activity before childbirth, bad habits - smoking during pregnancy).

        3. Presence of mental disorders before childbirth (level of anxiety 2 weeks before
           childbirth, widespread muscle pain with fatigue or problems with memory, sleep, and
           mood).

        4. The presence of chronic pain, chronic headache or chronic back pain, the presence of
           rheumatoid arthritis during pregnancy, the presence of increased intracranial pressure
           during pregnancy.

        5. Presence of chronic intestinal diseases (irritable bowel syndrome).

        6. The level of assistance during childbirth (constant support of the doula during
           childbirth, the woman's ability to control pain in childbirth).
    

Intervention name(s): Visual analogue scale (VAS); General anxiety scale (GAD-2) and survey
Intervention type(s): Diagnostic Test; Diagnostic Test
Intervention description(s): In the postpartum period all patients filled VAS and underwent interviews from the 1st to the 3rd day after delivery.; In the postpartum period all patients filled survey with GAD-2 and underwent interviews from the 1st to the 3rd day after delivery.
Observational model: Other
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        mothers over 18 years of age, 1st or 2nd parturitions, childbirth with the birth of the
        alive fetus
      
Keywords: labor pain; antenatal education; support by doula
Study of Bimatoprost Gel on Eyelash Growth
Condition: Madarosis; Hypotrichosis
MeSH terms: Hypotrichosis
Study type: Interventional
Phase: Phase 3

Summary: 
      A internally controlled, single-blinded, randomized controlled trial to investigate the use
      of Bimatoprost eyelash gel on eyelash growth and appearance in breast cancer patients who
      suffer from madarosis (loss of eyelashes) due to the side effects of chemotherapy. IND and
      IRB approval have been obtained.
    


Intervention name(s): Bimatoprost eyelash gel
Intervention type(s): Drug
Intervention description(s): Bimatoprost 0.03% solution was compounded into a gel - patients used on eyelash margin once daily placing gel with a fingertip or Q-tip for 6 months
Other intervention name(s): lumigan
Intervention MeSH terms: Bimatoprost
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Pharmacokinetic Study of JNJ-42756493 in Healthy Participants
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the absolute bioavailability (the extent to which a
      drug or other substance becomes available to the body) of JNJ-42756493 following a single 10
      milligram (mg) dose as an oral solution administered in combination with a single intravenous
      administration of a microdose (100 microgram [mcg]) of JNJ-61818549 and to evaluate the
      relative bioavailability of 10 mg JNJ-42756493 following an oral solution (reference) and a
      tablet (test) formulation in a crossover (method used to switch subjects from one study group
      to another in a clinical trial) design in healthy participants.
    

Detailed description: 
      This is a randomized (study drug assigned by chance), open-label (all people know the
      identity of the intervention), 2-way crossover, single-dose, and single-center, Phase 1 study
      of oral JNJ-42756493 in healthy participants. The duration of the study is approximately
      36-63 days: 2-20 days Screening, two 7 days open-label treatment periods, 12-14 days washout
      and 12-14-day follow-up (Day 13-15 of period 2). All participants will be randomly assigned
      to 1 of 2 treatment sequences. In Treatment Sequence AB: JNJ-42756493 10 mg tablet
      formulation will be administered on Day 1 of Period 1 and 100 mcg JNJ-61818549 will be
      administered intravenously 2 hours after the intake of 10 mg JNJ-42756493 oral solution on
      Day 1 of Period 2. In Treatment Sequence BA: 100 mcg JNJ-61818549 will be administered
      intravenously after the intake of 10 mg JNJ-42756493 oral solution on Day 1 of Period 1 and
      10 mg JNJ-42756493 tablet formulation will be administered on Day 1 of Period 2. A minimum 12
      days washout is required between treatment periods. Participants will primarily be analyzed
      for pharmacokinetics (the study of the way a drug enters and leaves the blood and tissues
      over time). Participants' safety will be monitored throughout the study.
    

Intervention name(s): JNJ-42756493 10 mg tablet; JNJ-42756493 10 mg Oral Solution; JNJ-61818549
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Participants will be administered with 10 milligram (mg) JNJ-42756493 tablet orally either on Day 1 of Period 1 or on Day 1 of Period 2.; Participants will be administered with 10 mg JNJ-42756493 oral solution either on Day 1 of Period 1 or on Day 1 of Period 2.; Participants will receive 100 mcg of JNJ-61818549 as intravenous injection on Day 1 of Period 2 or Day 1 of Period 1.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Healthy; JNJ-42756493; JNJ-61818549; Isotope
Single Ascending Dose Study for Evaluation of Safety, Tolerability and Pharmacokinetics of L606
Condition: Pulmonary Arterial Hypertension
MeSH terms: Pulmonary Arterial Hypertension
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective of this study is to evaluate the Pharmacokinetics, Safety and
      Tolerability of L606 (Liposomal Treprostinil) Inhalation Solution in Single Ascending Dose
      study design in healthy volunteers.
    

Detailed description: 
      L606 (Liposomal Treprostinil) Inhalation Solution and dedicated inhalation system is
      developed by Pharmosa Biopharm Inc. intended to improve the inconvenience, as one of the
      greatest impediments to patient satisfaction to current inhaled treprostinil therapy.
      Pharmosa's liposomal technology offers sustained release of treprostinil which enable bid
      treatment instead of conventional qid treatment offered by current inhaled treprostinil
      therapy for treatment of patients with PAH (WHO Group 1).
    

Intervention name(s): L606 (Liposomal Treprostinil) Inhalation Solution 51ug; L606 Inhalation System; Placebo Solution
Intervention type(s): Drug; Device; Other
Intervention description(s): Single ascending dose; Single ascending dose; Single ascending dose
Other intervention name(s): Drug: L606 (Liposomal Treprostinil) Inhalation Solution; Device: L606 Inhalation Solution
Intervention MeSH terms: Treprostinil; Pharmaceutical Solutions
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Other