bioihbjkbjnl/mcl2 huggingface dataset:
The Role of the P2Y12 Receptor in Tissue Factor Induced Coagulation
Condition: Healthy Volunteers; Sepsis
Study type: Interventional
Phase: Phase 4

Summary: 
      Severe sepsis still carries a high mortality rate despite advantages in intensive care
      medicine and antimicrobial therapy. The inflammatory and procoagulant host response to
      infection are intricately linked and interactions between platelets, leukocytes and the
      endothelium play a central role in the pathogenesis of septic shock and disseminated
      intravascular coagulation (DIC). Interestingly, one key player cell in coagulation, i.e. the
      platelet, has been somewhat neglected as to its position in the pathogenesis of coagulation
      abnormalities in sepsis. However, thienopyridines, irreversible platelet P2Y12 ADP-receptor
      antagonists, e.g. prasugrel, could potentially provide beneficial anticoagulatory and
      antiinflammatory effects: P2Y12 ADP-receptor antagonists reduce TF-induced coagulation
      activation in various ex vivo and in vitro models. Moreover, various lines of evidence
      indicate that thienopyridines may block platelet leukocyte interactions and thereby reduce
      the propagation of the coagulation and inflammation process.

      LPS-infusion in healthy volunteers provides a standardized model to safely study non overt
      DIC and to document possible effects of therapeutic and prophylactic interventions.

      The investigators hypothesize that thienopyridines, irreversible platelet P2Y12 ADP-receptor
      antagonists, may blunt TF-triggered coagulation activation in humans, which will be studied
      in a TF-dependent coagulation model in humans.
    


Intervention name(s): Prasugrel; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Prasugrel will be given as loading dose (60mg) on the first trial day two hours prior to endotoxin infusion. Prasugrel is an orally administered prodrug that is converted in the liver by CYP to its active metabolite.; A pharmacist not otherwise involved in the trial will encapsulate pills consisting of lactose-starch. Six pills will be administered as placebo 2 hours before LPS administration on trial day 1.
Other intervention name(s): Generic name: Prasugrel; Brand name: Efient; Manufacturer: Eli Lilly; Dose: 60mg loading dose (6 tablets a 10mg) on trial day 1; Content: Pills consisting of lactose-starch; Manufacturer: AKH Anstaltsapotheke; Dose: Same number of pills as in the prasugrel period (6 tablets on trial day 1); identically encapsulated by a pharmacist not otherwise involved in the trial
Intervention MeSH terms: Prasugrel Hydrochloride
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: human endotoxemia; tissue factor induced coagulation; platelet activation; thienopyridines
A Comparison of Two Surface Materials (Tantalum Versus Titanium Fiber Mesh) of Acetabular Components in Hip Arthroplasty
Condition: Osteoarthritis
MeSH terms: Osteoarthritis
Study type: Interventional

Summary: 
      The purpose of this study is to compare two surface materials (tantalum versus titanium fiber
      mesh) of acetabular components in hip arthroplasty.
    

Detailed description: 
      In younger patients, acetabulum components are most often implanted without the use of
      cement. A direct ingrowth of bone to the implant is crucial to the attainment of good results
      in those cases where cement is not employed. A new implant material (tantalum) has shown
      better properties than the implant material which is in use today (titanium). The advantages
      of tantalum implants are greater porosity, reduced stiffness and a higher friction
      coefficient than with titanium implants.

      Hypothetically, the higher porosity of tantalum should enhance bone ingrowth due to better
      osteoconductivity in terms of:

        1. less migration of the acetabulum component, as evaluated by RSA;

        2. increased BMD in the bone surrounding acetabulum components;

        3. fewer postoperative complaints on the Harris Hip Score and visual analog scale scores.

      The migration of acetabulum components will be evaluated by RSA. The follow-up RSA will be
      scheduled for week 1, as well as 3 months, 12 months and 2 years after surgery. Bone mineral
      density around the implanted femoral component will be examined by DEXA scan at week 1, as
      well as 1 year and 2 years after surgery.
    

Intervention name(s): Acetabular implant, Monoblock cup
Intervention type(s): Device
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: RSA; DEXA; Osteoarthritis; Hip arthroplasty
Dose Response Trial of Pergolide for Cocaine Dependence - 1
Condition: Cocaine-Related Disorders
MeSH terms: Cocaine-Related Disorders
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate the efficacy and safety of pergolide for treatment
      of cocaine dependence.
    


Intervention name(s): Pergolide
Intervention type(s): Drug
Intervention MeSH terms: Pergolide
Primary purpose: Treatment
Ph II SAHA and Bevacizumab for Recurrent Malignant Glioma Patients
Condition: Recurrent Glioblastoma Multiforme; Malignant Glioma; Adult Brain Tumor
MeSH terms: Glioblastoma; Glioma; Brain Neoplasms; Recurrence
Study type: Interventional
Phase: Phase 2

Summary: 
      It has been shown that bevacizumab has significant anti-tumor activity in patients with
      recurrent glioblastoma multiforme. Vorinostat has modest anti-tumor activity against
      malignant glioma and can enhance the action of both chemotherapy and anti-angiogenics.
      Patients will be treated with a combination of bevacizumab and vorinostat.
    

Detailed description: 
      There is no effective therapy for patients with recurrent glioblastoma multiforme (GBM) hence
      such patients remain a major unmet need in oncology. The investigators have recently
      demonstrated that bevacizumab (BV), a humanized monoclonal antibody against vascular
      endothelial growth factor, has significant anti-tumor activity among recurrent glioblastoma
      multiforme patients. Vorinostat has modest anti-tumor activity against malignant glioma and
      can potentiate the action of both chemotherapy and anti-angiogenics. The current study is
      designed to evaluate the anti-tumor activity of vorinostat when combined with BV among
      recurrent glioblastoma multiforme patients.
    

Intervention name(s): Vorinostat; Bevacizumab
Intervention type(s): Drug; Drug
Other intervention name(s): SAHA; Avastin
Intervention MeSH terms: Bevacizumab; Vorinostat
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: vorinostat; SAHA; bevacizumab; AVASTIN; malignant glioma; GBM; glioblastoma multiforme; brain tumor
Assessment of the Clinical Condition and Way of Nutrition Patients Before and After Sleeve Gastrectomy
Condition: Obesity
MeSH terms: Obesity
Study type: Observational

Summary: 
      Conservative treatment of patients with morbid obesity is inefficient, which is why surgical
      treatment is necessary. Although bariatric treatment is associated with the occurrence of
      complications resulting from the procedure or from nutritional insufficiencies, it leads to
      significant body mass reduction and metabolic improvement of obese patients.

      The aim of the study was to determine the clinical condition of obese patients after
      laparoscopic sleeve gastrectomy ( LSG) in terms of nutritional status, metabolic disorders
      and way of nutrition.

      The study conduced 4 visits: preliminary visit (1 day before the surgery) and control visits
      (1, 3 and 6 months after the surgery). Based on the inclusion and exclusion criteria the
      observational study was conducted among 30 participants (15 women and 15 men).
    


Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        The study included 30 obese patients (15 women and 15 man) who met the criteria for beaing
        included in the study and who did not possess excusion criteria.inclusion criteria
      
Keywords: bariatric surgery; nutrition; body composition; nutritional status; obesity; laparoscopic sleeve gastrectomy
A Registry for Patients Taking Uptravi
Condition: Pulmonary Arterial Hypertension
MeSH terms: Pulmonary Arterial Hypertension
Study type: Observational [Patient Registry]

Summary: 
      This is a US multi-center, prospective, real world, observational drug registry enrolling
      patients actively treated with Uptravi. Participating patients will be followed prospectively
      for a maximum of 18 months from the date of enrollment into the registry.
    


Observational model: Other
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        The number of patients planned to be enrolled in the study is approximately 800 patients
        from approximately 80 centers in the U.S.
Validation of the MoistureMeterD in Local Edema by Histamine
Condition: Lymphedema
MeSH terms: Lymphedema
Study type: Interventional

Summary: 
      In lymphedema there is increase in water content of the tissue. We studied a device
      (MoistureMeterD) which is suitable to detect water contact in the tissue. Although the
      apparatus is commercially available, no validation study had been performed in vivo with
      local edema.

      We designed a validation study for inter- and intra observer variability and the
      reproducibility in vivo by histamin induced local edema
    

Detailed description: 
      The multiprobe Delfin MoistureMeterD is a unique and compact water-specific instrument for
      the measurement of water content of biological tissues. It measures the dielectric constant
      values of the skin and subcutaneous tissues non-invasively and locally in a few seconds. The
      dielectric constant value is directly proportional to the amount of water in the tissue.

      As lymphedema produces local water content increase, we are interested if the device is
      suitable for daily use in lymphedema patients. Therefore we designed a protocol to measure
      the results with a moisturemeter in a standardized edema formation by histamin induced
      scratch test edema. This method is well known in type I allergy testing.

      The aim of the study is:

        1. research the inter- and intra observer variability

        2. measure the reproducibility of edema formation in a standardized edema formation
    

Intervention name(s): MoistureMeterD
Intervention type(s): Device
Intervention description(s): measuring erythema size and the dielectric constant values
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: local edema; dielectric constant values; validation study
Prospective Randomized Study Comparing Ex-PRESS to Trabeculectomy
Condition: Glaucoma
MeSH terms: Glaucoma
Study type: Interventional

Summary: 
      Prospective randomized study comparing guarded Ex-PRESS to trabeculectomy. Primary outcome:
      IOP and success (complete success defined as IOP between 5-18 mmHg and 20% reduction from
      baseline without medication or additional glaucoma surgery and qualified success defined as
      IOP between 5-18 mmHg and 20% reduction from baseline with or without glaucoma medication but
      no additional glaucoma surgery). Secondary outcomes: number of glaucoma medications, visual
      acuity, number of complications, corneal pachymetry and corneal endothelial cell counts.
    

Detailed description: 
      Complications will be evaluated for the intra-operative, early post-operative (up until 1
      month) and late post-operative (from 1 month to 1 year) periods. In addition complications
      will be evaluated as severe (defined as a permanent reduction in vision or complications
      requiring a surgical intervention) and not severe (complications which resolve with
      conservative management). As an individual subject may have more than one complication, the
      number of complications will be compared between the two surgical groups.
    

Intervention name(s): ExPRESS shunt; trabeculectomy
Intervention type(s): Procedure; Procedure
Intervention description(s): ExPRESS miniature glaucoma drainage device; trabeculectomy filtering surgery
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: glaucoma; filtration surgery; trabeculectomy; ExPRESS shunt
The Effect of Dorsal Genital Nerve Stimulation on Opening Urethral Pressure
Condition: Stress Urinary Incontinence
MeSH terms: Urinary Incontinence; Urinary Incontinence, Stress
Study type: Interventional

Summary: 
      This study aims to investigate the effect of electrical stimulation of the dorsal genital
      nerve on the urethral pressure in healthy women.
    


Intervention name(s): Dorsal genital nerve stimulation
Intervention type(s): Device
Intervention description(s): Two types of stimulation electrodes will be used: UCon Patch Electrodes (InnoCon Medical ApS, Denmark) and ValuTrodes/EconoStim Electrodes (5x5 cm, Axelgaard Manufacturing Co. Ltd., United States). The UCon Patch Electrode acts as a cathode and will be placed on the clitoris. The ValuTrode/EconoStim acts as an anode and will be placed on the lower abdomen. The continuous stimulation consists of a train of single pulses provided continuously with a frequency of 20 Hz and a pulse duration of 200 μs. The burst stimulus pattern consists of a train of bursts. The length of the train is 10 s and will consist of 20-30 bursts/s. One burst consists of 5 identical square pulses (monophasic). The inter-pulse interval is 4 ms (time between the onset of 2 consecutive pulses) while a pulse duration of 200 μs will be used.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Electrical Stimulation; Urethral pressure; Neuromodulation
A Water Consumption Study of ALKS 5461 in Healthy Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will evaluate the impact of water consumption on the pharmacokinetics of ALKS
      5461.
    


Intervention name(s): ALKS 5461
Intervention type(s): Drug
Intervention description(s): Sublingual tablet administered followed by consumption of 240 mL (8 ounces) of water at different timepoints
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Alkermes; Samidorphan; ALKS 5461; Healthy Volunteer; Pharmacokinetics
A Pilot Study Exploring the Efficacy and Safety of Herbal Medicine on Korean Obese Women With Metabolic Syndrome Risk Factors - Double Blinded, Randomized, Multicenter, Placebo Controlled Clinical Trial -
Condition: Metabolic Syndrome; Obesity
MeSH terms: Metabolic Syndrome; Syndrome
Study type: Interventional
Phase: Phase 4

Summary: 
      The Purpose of this trial is to investigate the efficacy and safety of Daesiho-tang and
      Taeeumjowi-tang on Korean obese Women with metabolic syndrome Risk factors
    


Intervention name(s): Daesiho-tang; Chowiseungcheng-tang; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Usage: 6g, three times a day, each taken before or between meals for 12 weeks Manufacturing company: HANPOONG PHARM & FOODS Co. Ltd.; Usage: 6g, three times a day, each taken before or between meals for 12 weeks Manufacturing company: Hanzung Pharmaceutical. co. Ltd.; Usage: 6g, three times a day, each taken before or between meals for 12 weeks Manufacturing company: HANPOONG PHARM & FOODS Co. Ltd.
Other intervention name(s): DSHT; Elsion Granule; CST
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: metabolic syndrome; Daesiho-tang; Taeeumjowi-tang; Korean medicine
Improving Gait in Patients With Spinal Cord Injuries
Condition: Spinal Cord Injuries
MeSH terms: Spinal Cord Injuries
Study type: Interventional
Phase: Phase 2

Summary: 
      This study is part of a larger clinical trial that examines the potential of a 12-week
      treadmill-training program to improve walking in patients with spinal cord injuries (SCIs).
      Patients in the trial are at least 1 year past their injury. This substudy tests a
      combination of two strategies to enhance the treadmill training program: electrically
      stimulating a muscle withdrawal reflex and providing body weight support by partially
      suspending patients as they walk on the treadmill.
    

Detailed description: 
      Patients with spastic paresis due to incomplete SCI have inadequate motor control of the
      lower extremities that results in a number of abnormalities of movement. Among these are
      unregulated spinal reflexes, inadequate and delayed motor recruitment, and balance deficits.
      If the patient can walk, these abnormalities manifest in a gait pattern that has poorly
      coordinated timing between different muscle groups, decreased weight bearing capacity, and
      inappropriate muscle activity, such as scissoring.

      Research in patients with SCIs has demonstrated that, despite the damage to the spinal cord,
      many of the nervous system pathways that control walking remain intact and can be activated
      by the proper sensory stimulation. Two technologies that may enhance the benefits of
      treadmill walking are body weight support (BWS) and functional electrical stimulation (FES).
      Preliminary studies indicate that by combining these two interventions, gait performance is
      improved such that more efficient and functional movement emerges. This study will evaluate
      the benefits of adding BWS and FES to a treadmill-training program for patients with SCIs.

      During the treadmill training, patients are suspended in an apparatus to provide partial body
      weight support (BWS). The training effects of BWS locomotion with FES over the course of a
      multi-session training program will be examined. Study visits will be scheduled 3 days each
      week for 12 weeks. Participants will have follow-up visits at Months 3 and 12. Gait
      parameters modified by training will be identified and the nature of these changes will be
      characterized. Specifically, walking speed, kinematics, electromyography (EMG), and muscle
      strength will be assessed.
    

Intervention name(s): Body weight supported locomotor training; Functional electrical stimulation
Intervention type(s): Procedure; Procedure
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single
Primary purpose: Treatment
Keywords: Locomotion; Spinal Cord Injury, ASIA C; Body weight support (BWS); Functional electrical stimulation (FES); Gait; Treadmill training; Physical Therapy
Gemcitabine and Cisplatin as First Line Combination Therapy in Patients With Triple-negative MBC
Condition: Metastatic Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      Primary objective of this study is to evaluate the efficacy of gemcitabine and cisplatin as
      first line therapy in patients with triple-negative MBC. 80 patients will be treated into
      this study.
    

Detailed description: 
      Triple-negative breast tumors could contribute to the poor prognosis comparing with luminal A
      breast cancer.Fewer study has revealed that Cisplatin-based therapy may be effective for this
      type breast cancer.
    

Intervention name(s): gemcitabine and cisplatin
Intervention type(s): Drug
Intervention description(s): Cispaltin 25mg/m2，ivgtt，D1, 2, 3 gemcitabine 1000mg/m2，ivgtt，30'，D1, 8 repeat every 3 weeks
Other intervention name(s): gemzar
Intervention MeSH terms: Gemcitabine
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Metastatic Breast Cancer; triple-negative Breast Cancer; cisplatin; chemotherapy
Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Ex-vivo Antitubercular Activity of PBTZ169 Formulation
Condition: Tuberculosis; Tuberculosis, Pulmonary
MeSH terms: Tuberculosis; Tuberculosis, Pulmonary
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a randomized, double-blind, placebo-controlled, single ascending dose study conducted
      at one study center in Switzerland.

      Four (4) panels (A, B, C and D) of 8 male subjects (6 active and 2 placebo) each undergoing 2
      investigation periods and receiving either single doses of PBTZ169 at increasing dose levels
      or a matching placebo.

      Subjects will participate in only one panel. Blocks of 4 subjects (3 under active treatment,
      1 under placebo) will be investigated in parallel. Panels A and B are interleaved.

      Safety will be assessed throughout the study; serial ECGs and serial blood samples will be
      collected for the safety and PK assessment of PBTZ169.

      Dose escalation will be allowed once the Trial Safety Board has determined that adequate
      safety and tolerability after panel B and panel C completion has been demonstrated to permit
      proceeding to the next panel.
    


Intervention name(s): PBTZ169 Formulation; Placebo; PBTZ169 NCP
Intervention type(s): Drug; Drug; Drug
Intervention description(s): PBTZ169 Formulation supplied as powder for oral solution; matching placebo supplied as powder for oral solution; PBTZ169 NCP supplied as powder for oral solution
Intervention MeSH terms: Macozinone
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment