bioihbjkbjnl/mcl2 huggingface dataset:
A Study to Assess the Safety, Tolerability, and Blood and Urine Drug Levels of Fostamatinib Disodium (FosD) in Healthy Japanese and White Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a single and multiple ascending dose study in healthy male and female (of non-child
      bearing potential) Japanese and White volunteers, to assess the safety, tolerability, and
      blood and urine drug levels of FosD. FosD is being developed for the treatment of rheumatoid
      arthritis.
    


Intervention name(s): FosD; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): oral tablet; oral tablet
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: fostamatinib disodium; FosD; Japanese; Healthy volunteers; Phase 1; Single and Multiple Ascending Dose Study; Healthy Japanese volunteers; Healthy White volunteers
Safety and Efficacy of RX-10100 to Treat Major Depressive Disorder
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine whether RX-10100 are effective in the treatment of
      Major Depressive Disorder (MDD).
    


Intervention name(s): RX-10100
Intervention type(s): Drug
Intervention description(s): Extended-release tablet, taken twice daily for 8 weeks
Other intervention name(s): Serdaxin®
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: MDD; Depression; Major Depression
Phase I Study of Sintilimab in Healthy Chinese Male Subjects
Condition: Healthy Male Subjects
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the pharmacokinetic similarity of sintilimab with
      different manufacturing process in healthy male subjects. Another purpose is to determine
      safety, and immunogenicity of sintilimab with different manufacturing process，also to
      determine Pharmacodynamics of sintilimab with different manufacturing process in 12 healthy
      male subjects.
    


Intervention name(s): sintilimab (after the change); sintilimab (before the change)
Intervention type(s): Drug; Drug
Intervention description(s): 0.3mg/kg，I.V.，single dose; 0.3mg/kg，I.V.，single dose
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Other
The Neuroprotective Effects of RPC on the Neurosurgery
Condition: s100b
Study type: Interventional
Phase: Phase 1

Summary: 
      The current study is designed to clarify the neuroprotective effect of remote ischemic
      precondtioning on the patients underwent neurosurgery.
    

Detailed description: 
      BACKGROUND: Brain ischemia and injury are commonly contributed to perioperative morbidity and
      mortality after neurosurgery. Remote ischemic preconditioning (RIPC) is a phenomenon whereby
      brief periods of ischemia followed by reperfusion in one organ provide systemic protection
      from prolonged ischemia. To investigate whether remote preconditioning protects the brain
      injury in patients undergoing elective neurosurgery, a randomized trial will be performed in
      current study.

      DESIGNING Thirty patients undergoing craniotomy for supratentorial meningioma will be
      randomize assigned to neurosurgery with RIPC or conventional neurosurgery (control). Remote
      ischemic preconditioning consist of three 5-min cycles of right upper limb ischaemia, induced
      by an automated cuff-inflator placed on the upper arm and inflated to 200 mm Hg, with an
      intervening 5 min of reperfusion during which the cuff is deflated. Cerebral injury was
      assessed by S-100b, NSE, and neurological function scores in different time points.

      EXPECTED RESULTS RIPC will reduce the incidence of cerebral injury.

      CONCLUSIONS:

      In patients undergoing elective craniotomy for supratentorial meningioma, RIPC reduces the
      incidence of postoperative cerebral injury.
    

Intervention name(s): remote preconditioning
Intervention type(s): Procedure
Intervention description(s): Remote ischemic preconditioning consist of three 5-min cycles of right upper limb ischaemia, induced by an automated cuff-inflator placed on the upper arm and inflated to 200 mm Hg, with an intervening 5 min of reperfusion during which the cuff is deflated.
Other intervention name(s): remote ischemic preconditioning; RIPC
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Experimental
MOD-4023 Study in Healthy Male Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This study aims to examine the safety, tolerability and pharmacokinetics of a long-lasting
      Human Growth Hormone (MOD-4023) in healthy volunteers after a single subcutaneous injection
      at escalating doses.
    


Intervention name(s): MOD-4023 (long lasting hGH); Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Single subcutaneous dose of MOD-4023; Single subcutaneous dose of placebo material
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Healthy Male Volunteers
Hemodynamic Effects of Terlipressin and High Dose Octreotide
Condition: Gastric and Esophageal Varices
MeSH terms: Esophageal and Gastric Varices
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of the study is to find patients's response to terlipressin and octreotide during
      hepatic venous pressure gradient measurement by observing portal and systemic hemodynamics.
    

Detailed description: 
      Esophageal variceal bleeding is one of the main causes of death in cirrhosis patients.
      Prevention of bleeding events, including primary and secondary prophylaxis, is very important
      for reducing the mortality of variceal bleeding. Terlipressin and octreotide can effectively
      control bleeding with few side effects, which has been recommended by Baveno V in treatment
      of acute variceal bleeding. Terlipressin and high dose octreotide will be administered to the
      patients with cirrhosis related esophageal varices when they undergo hepatic venous pressure
      gradient measurement. Changes from portal and systemic hemodynamics will be observed to
      evaluate the safety and effects of terlipressin and high dose octreotide as well as to
      determine wether patients respond to them. The results can be served as clinical evidence for
      preventing re-bleeding through long-acting terlipressin and octreotide in the future.
    

Intervention name(s): Terlipressin; Octreotide
Intervention type(s): Drug; Drug
Intervention description(s): Patients in the terlipressin group receive a single IV injection of 2 mg of terlipressin and a continuous IV infusion of normal saline.; Patients in high dose octreotide receive a single injection of 100μg octreotide and continuous IV infusion of 50 μg/h of octreotide.
Other intervention name(s): HanWei; ShanNing
Intervention MeSH terms: Octreotide; Terlipressin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Gastric and Esophageal Varices; Hepatic Venous Pressure Gradient; Terlipressin; Octreotide
Physiological Effects of Androstadienone Exposure
Condition: Healthy
Study type: Observational

Summary: 
      The reason for doing this research is to understand why different people show different
      responses when they smell an odor called androstadienone. Androstadienone is a chemical found
      in male sweat. Other studies have shown that smelling this chemical can cause people to
      experience sweating, changes in skin temperature, and changes in a stress hormone call
      cortisol. These responses, which are called "physiological effects," are stronger in some
      people than in others.

      We are interested in finding out whether these individual differences are genetic, that is
      caused by differences in our genes. Humans have about 1000 genes for odorant receptors. These
      are the molecules that bind and detect odor molecules in our nose and allow us to respond to
      so many different odors. It has been shown that some of these genes exist in two forms: a
      functional one and one that has been mutated and is therefore no longer functional.

      We think that people who do not respond to a specific odor may carry the non-functional form
      of the gene for the receptor that detects the odor molecule. To test this idea we want to
      find people who respond strongly to a specific smell, and compare their odorant receptor
      genes with those of people who respond weakly to the odor.
    

Detailed description: 
      The study consists of five visits. The first visit is a screening visit at which the
      eligibility of the subject is determined and a blood sample is taken. At this visit, the
      subject is also given ovulation test strips and instructions to perform urine-based ovulation
      self-tests at home for a period of several days following the onset of menstruation. The
      subject is instructed to test her urine at home until an LH surge is detected.

      When the subject ovulates and is available for a visit she will come to the Rockefeller
      University Hospital within one day of detecting an LH surge for the first of four Test
      Sessions.

      The four Test Sessions are identical with the exception that the subject is exposed to a
      different odor stimulus.

      We will be measuring:

        1. skin temperature

        2. sweating, as measured by skin conductance

        3. salivary cortisol levels.

        4. mood
    

Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Healthy adult women between 18-35 years of age.
      
Biospecimen description: 
      Blood
    
Keywords: smell; olfaction; androstadienone; women; pheromones; Healthy Volunteers; Physiological Effects of Androstadienone Exposure
Mycophenolate Sodium Treatment in Patients With Primary Sjogren's Syndrome
Condition: Primary Sjogren's Syndrome
MeSH terms: Sjogren's Syndrome; Syndrome
Study type: Interventional
Phase: Phase 1

Summary: 
      Primary Sjogren's syndrome (pSS) is an autoimmune disorder characterized by
      keratoconjunctivitis sicca and xerostomia. In addition, various extraglandular manifestations
      may develop. Several immunomodulating agents have been attempted in the treatment of pSS
      without achieving satisfactory results. Currently, there is no approved systemic treatment
      for pSS.

      Mycophenolic acid (MPA) is a selective inhibitor of inosine-monophosphate-dehydrogenase which
      leads to inhibition of the de novo pathway of nucleotide synthesis. The antiproliferative
      effect of MPA mainly affects activated T- and B-lymphocytes because the proliferation of
      these cells is critically dependent on the de novo purine synthesis compared to other
      eukaryotic cells. Since these lymphocytes have been suggested to play a pivotal role in the
      inflammation and immunopathogenesis of pSS, mycophenolate-sodium might be a promising agent
      in the treatment of pSS.

      We perform a single-centre, open-label pilot trial with Mycophenolate sodium in pSS.
    

Detailed description: 
      Mycophenolic acid containing compounds such as mycophenolate mofetil and enteric coated
      mycophenolate sodium are immunosuppressive drugs approved for the prevention of transplant
      rejection. Mycophenolate mofetil (MMF) is an effective treatment in systemic lupus
      erythematosus and other autoimmune diseases.

      MMF has been used as maintenance therapy after treatment with rituximab (anti-CD20 antibody)
      in a pSS patient. We have reported a case of successful treatment with MMF in pSS with
      vasculitis.

      The recent observations and the immunosuppressive effect of MPA in other autoimmune diseases
      led us to evaluate the efficacy and safety of MPA treatment in patients with pSS refractory
      to other immunosuppressive agents.

      The observation period will be 6 months. At baseline, after 3, and after 6 months we examine
      the clinical status including glandular function tests as well as different laboratory
      parameters associated with pSS. In addition subjective parameters will be determined on the
      basis of different questionnaires.
    

Intervention name(s): Mycophenolate sodium
Intervention type(s): Drug
Intervention description(s): Medical treatment is initiated with one tablet of 360 mg mycophenolate sodium orally per day for eligible patient. The dosage will be increased weekly by 360 mg up to a maximum stable dose of 1440mg daily. In patients not well tolerating the drug the dosage can be reduced to 720 mg per day.
Other intervention name(s): Myfortic
Intervention MeSH terms: Mycophenolic Acid
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Sjogren's syndrome; Mycophenolate sodium
A Study of An Approved Vaccine at Mumps Expiry Potency in Healthy Children 12 to 18 Months of Age (V205C-007)(COMPLETED)
Condition: Measles; Mumps; Rubella; Varicella
MeSH terms: Rubella; Mumps
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to determine the mumps virus strength at the end of shelf-life
      (expiration date) of an approved vaccine.
    


Intervention name(s): Comparator: M-M-R(TM) II, measles, mumps, and rubella virus vaccine live; Comparator: VARIVAX(TM) Varicella Virus Vaccine Live (Oka-Merck)
Intervention type(s): Biological; Biological
Intervention description(s): 0.5 mL subcutaneous injection of one of three sub-lots on Day 0; 0.5 mL subcutaneous injection on Day 0
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Conservative Versus Operative ManageMent of Acute Uncomplicated Appendicitis
Condition: Appendicitis
MeSH terms: Appendicitis
Study type: Interventional

Summary: 
      This study aims to compare antibiotic treatment versus surgery for patients with
      uncomplicated appendicitis.
    

Detailed description: 
      The study will include patients aged 16 and over, with a first admission with right iliac
      fossa pain and a raised white cell count or C-reactive protein. Patients will be randomised
      electronically in a 1:1 ratio either to undergo emergency appendectomy or to receive
      intravenous antibiotics as an inpatient, until clinical and biochemical improvement is
      observed, followed by outpatient oral antibiotics. Those who have surgery will have 3
      post-operative doses of intravenous antibiotics, unless perforation was identified at the
      time of surgery, in which case, microbiology will be contacted to advise regarding antibiotic
      choice and duration. Follow-up by telephone interview will be at 1 week, 1, 3 and 12-month
      intervals.
    

Intervention name(s): Laparoscopic +/- Open Appendicectomy; Antibiotic treatment
Intervention type(s): Procedure; Drug
Intervention description(s): Laparoscopic +/- open appendicectomy , with antibiotics at induction (intravenous co-amoxiclav 1.2g, or if penicillin allergic, cefuroxime 1.5g + metronidazole 500mg ), followed by 3 further intravenous doses of the same antibiotic. If a perforation is identified at the time of surgery, microbiology will be contacted regarding choice and duration of of antibiotic.; Intravenous co-amoxiclav 1.2g three times daily, then 625mg, orally three times daily. If penicillin allergic, intravenous cefuroxime 1.5g three times daily + metronidazole 500mg three times daily, then oral cefuroxime 500mg twice daily + oral metronidazole 400mg three times daily.
The patient will receive inpatient intravenous antibiotics until sufficient clinical improvement is noted by the surgical team, who will be assessing the patient twice daily. After discharge the patient will receive 5 further days of oral antibiotics.
Intervention MeSH terms: Anti-Bacterial Agents
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Study of Ritonavir-Boosted Danoprevir (RO5190591) in Combination With Pegasys and Ribavirin in Patients With Chronic Hepatitis C Genotype 1
Condition: Hepatitis C, Chronic
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will evaluate the efficacy, safety and tolerability of danoprevir (RO5190591) plus
      ritonavir as compared to danoprevir alone or placebo plus ritonavir in patients with chronic
      hepatitis C genotype 1 receiving Pegasys (peginterferon alfa-2a) and ribavirin. Patients in
      cohorts will be randomized to receive either oral doses of danoprevir, or danoprevir plus
      ritonavir, or placebo plus ritonavir. All patients will receive Pegasys (180mcg sc once
      weekly) plus ribavirin (1000-1200mg/day po), with the option to continue this treatment after
      completion of study drug treatment. Anticipated time on study treatment is up to 12 weeks.
    


Intervention name(s): danoprevir; peginterferon alfa-2a [Pegasys]; placebo; ribavirin; ritonavir
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): oral doses; 180 mcg sc once weekly; oral doses; 1000-1200mg/day po; oral doses
Intervention MeSH terms: Ritonavir; Ribavirin; Peginterferon alfa-2a
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Study to Evaluate Frozen Versus Refrigerated MMRV (Combined Measles, Mumps, Rubella, and Varicella) Investigational Vaccine (V221-016)
Condition: Measles; Mumps; Rubella; Varicella
MeSH terms: Measles; Chickenpox; Herpes Zoster; Rubella; Mumps
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to demonstrate that an investigational refrigerated vaccine with
      measles, mumps, rubella, and varicella is well tolerated and has similar immune response when
      compared to a frozen vaccine with measles, mumps, rubella, and varicella.
    


Intervention name(s): V221, measles, mumps, rubella and varicella (Oka/Merck) virus vaccine live / Duration of Treatment: 12 weeks
Intervention type(s): Biological
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Safety and Preliminary Efficacy of GLPG0634 in Methotrexate-refractory Active Rheumatoid Arthritis Patients
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Interventional
Phase: Phase 2

Summary: 
      -  Thirty six patients suffering from active rheumatoid arthritis despite continued
           treatment with methotrexate will be evaluated for improvement of disease activity when
           taking GLPG0634 or matching placebo for 4 weeks.

        -  During the course of the study, patients will also be examined for any side effects that
           may occur, and the amount of GLPG0634 present in the blood as well as the effects of
           GLPG0634 on disease- and mechanism of action-related parameters in the blood will be
           determined.
    


Intervention name(s): GLPG0634
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: methotrexate-refractory
Effects of Foot Muscle Strengthening in Daily Activity in Diabetic Neuropathic Patients
Condition: Diabetic Neuropathies
MeSH terms: Diabetic Neuropathies
Study type: Interventional

Summary: 
      The main objective of this trial is to investigate the effects of foot muscle strengthening
      in daily activity of patients with diabetic neuropathy.
    

Detailed description: 
      A randomized controlled trial will be performed with 77 patients with diabetic neuropathy.
      The participants will be randomly assigned into either a control group (recommended foot care
      by international consensus with no exercises) or an intervention group which will receive
      12-week physical therapy exercises, twice a week, under the supervision of a physiotherapist,
      and twice a week being remotely supervised by a software at home. Every exercise has its own
      progression depending on the subjects' execution, increasing in intensity and difficulty.

      The subjects will be evaluated in 5 different moments (Baseline, 6 weeks, 12 weeks, 24 weeks
      and 1 year follow-up)

      The hypothesis of this study is that the intervention group will increase daily activity
      levels, increase self-selected and rapid walking speed, reduce the incidence of plantar
      ulcers, increase foot health and functionality, improve symptoms, increase tactile and
      vibration sensitivity, increased passive range of motion, improved quality of life, increased
      isometric strength of the feet and production of beneficial biomechanical changes during
      walking compared to the control group after 12 weeks of intervention and follow-up year.
    

Intervention name(s): Intervention Group
Intervention type(s): Other
Intervention description(s): Patients will receive a physical therapy intervention in groups twice/wk, and using a software twice/ wk for 3 months, for foot and ankle strengthening, stretching and functional training. They must continue to exercise at home twice a week with the software supervision for one year.
Other intervention name(s): Foot and ankle kinesiotherapy
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: diabetic foot; therapeutic exercises; foot; preventive care; rehabilitation; Diabetic Neuropathy