bioihbjkbjnl/mcl2 huggingface dataset:
Clinical Trial of BI 425809 Effect on Cognition and Functional Capacity in Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 2

Summary: 
      The objective of the study is to investigate the efficacy, safety and pharmacokinetics of
      four different doses of BI 425809 once daily compared to placebo given for 12 weeks in
      patients with schizophrenia on stable antipsychotic treatment.
    


Intervention name(s): BI 425809 dose 1; BI 425809 dose 2; BI 425809 dose 3; BI 425809 dose 4; Placebo
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention MeSH terms: BI 425809
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Cell Therapy for Chronic Traumatic Cervical Incomplete Spinal Cord Injury
Condition: Spinal Cord Injury Cervical
MeSH terms: Spinal Cord Injuries; Wounds and Injuries
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This is a double-blind, randomized, placebo-controlled, multicenter clinical trial in which
      18 patients affected with chronic traumatic incomplete cervical spinal cord injury will be
      randomized to either the active treatment (2 doses of intrathecal WJ-MSC 3 months apart) or
      to placebo (2 intrathecal infusions, 3 months apart). Thereafter, patients will be
      followed-up for 12 months for safety and efficacy assessment.
    

Detailed description: 
      Double-blind, randomized, placebo-controlled, multicenter clinical trial that will include 18
      patients affected with chronic traumatic incomplete cervical spinal cord injury who will be
      randomized 1:1, stratified by center, to one of the 2 treatment arms of the study: WJ-MSC /
      WJ-MSC (at a dose of 1E6 ± 30% live cells / Kg of weight) or Placebo / placebo. Medication
      will be administered intrathecally at day 1 and at 3 months. The main objective of the trial
      is to assess safety at a 12-month follow-up. Secondary objectives include the evaluation of
      efficacy through clinical response, electrophysiological changes, questionnaires of
      functionality and quality of life, as well as the presence of anti-HLA antibodies and donor
      cellularity in the cerebrospinal fluid.
    

Intervention name(s): WJ-MSC (XCEL-UMC-BETA); Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Administration of 2 Intrathecal infusions of WJ-MSC at day 1 and at 3 months; Administration of 2 Intrathecal infusions of placebo at day 1 and at 3 months
Other intervention name(s): Tested product
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Double-blind, randomized, placebo-controlled, 2-arms, multicenter clinical trial
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: spinal cord injury; Mesenchymal stromal cells; Wharton jelly; Cell therapy
Phlebotomy and Polycystic Ovary Syndrome
Condition: Hyperandrogenism; Metabolic Cardiovascular Syndrome
MeSH terms: Polycystic Ovary Syndrome; Hyperandrogenism; Metabolic Syndrome; Syndrome
Study type: Interventional

Summary: 
      AIMS To study the effects of the decrease in iron tissue depots after scheduled bloodletting
      on insulin sensitivity, carbohydrate metabolism, classic and non-classic cardiovascular risk
      factors in patients with functional hyperandrogenism (polycystic ovary syndrome & idiopathic
      hyperandrogenism) on standard treatment with combined oral contraceptives (COC) according to
      usual clinical practice.

      METHODOLOGY

      Open label, controlled, parallel, prospective study of 12 months of duration, with 2
      randomized arms of follow-up:

      i) Intervention Group: Patients with functional hyperandrogenism on standard COC treatment
      randomly allocated to perform scheduled phlebotomies from the third month of treatment to the
      end of the study (3 times with a 3-month interval between them).

      ii) Control Group: Patients with functional hyperandrogenism on standard COC treatment
      randomly allocated to follow-up without bloodletting.

      The whole group of patients will undergo a comprehensive anthropometric and hormonal
      assessment, evaluation of classic cardiovascular risk factors (insulin sensitivity and
      carbohydrate metabolism after a standard oral glucose test- 75 g), lipid profile, ambulatory
      and office blood pressure monitoring, proinflammatory profile, oxidative stress status,
      autonomic function assessment, and iron-related metabolism parameters at baseline, after
      3-month COC treatment and after reduction of iron tissue depots plus OC in the Intervention
      Group of patients, and throughout follow-up under treatment with COC in the Control Group of
      patients. If a significant relationship between circulating hepcidin levels and elevated
      ferritin concentrations is observed, a study of the potential influence of
      mutations/polymorphic variants of hepcidin gene on ferritin values will be performed as well.
    


Intervention name(s): Phlebotomy; ethinylestradiol; Cyproterone Acetate
Intervention type(s): Procedure; Drug; Drug
Intervention description(s): Scheduled standard phlebotomy every three months from month 3 to 12 of follow-up.; 35 mcg ethinylestradiol qd for 21 days per month as usual clinical practice.; 2 mg cyproterone acetate qd for 21 days per month as usual clinical practice.
Other intervention name(s): Blood donation; Bloodletting
Intervention MeSH terms: Cyproterone Acetate; Ethinyl Estradiol; Cyproterone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Functional hyperandrogenism; Polycystic ovary syndrome; Idiopathic hyperandrogenism; Iron tissue depots; Phlebotomy; Insulin resistance; Carbohydrate metabolism; Blood pressure; Autonomic dysfunction; Oxidative stress; Blood clotting tests; Efficacy; Side effects; Randomized clinical trial
Energy Homeostasis Under Treatment With Atypical Antipsychotics
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to evaluate the effects of different atypical antipsychotics on
      weight changes, energy homeostasis, metabolism, energy intake as well as activity.

      Patients with schizophrenia or schizoaffective disorders will be randomly assigned to be
      treated with ziprasidone or olanzapine for 24 weeks.

      Primary outcome parameter are the weight changes after 24 weeks.
    


Intervention name(s): olanzapine; Ziprasidone
Intervention type(s): Drug; Drug
Intervention description(s): treatment with either Olanzapine or Ziprasidone; treatment with either Olanzapine or Ziprasidone
Other intervention name(s): Zyprexa; Zeldox
Intervention MeSH terms: Olanzapine; Ziprasidone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: weight gain; schizophrenia; atypical antipsychotics
Seprafilm in the Reduction of Incidence of Bowel Obstruction in General Surgery
Condition: Intestinal Obstruction; Digestive System Surgical Procedures
MeSH terms: Intestinal Obstruction
Study type: Interventional

Summary: 
      The purpose of the study is to evaluate the efficacy of Seprafilm in reducing the incidence
      of bowel obstruction and to evaluate the incidence of all serious adverse events (SAEs)
      associated with the use of Seprafilm occurring within 30 days postoperatively, and the
      incidence of abdominopelvic abscess within 6 months postoperatively.
    


Intervention name(s): Seprafilm Bioresorbable Membrane
Intervention type(s): Device
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single
Primary purpose: Treatment
Keywords: Patients undergoing a variety of abdominal surgical procedures
Ultrasonography Biofeedback for Diaphragm Training in Athletes With Non-specific Lumbo-pelvic Pain
Condition: Ultrasonography; Low Back Pain
MeSH terms: Low Back Pain; Pelvic Pain
Study type: Interventional

Summary: 
      Objective: To determine the effectiveness of diaphragm visual biofeedback reeducation by
      ultrasonography in conjunction with high-intensity inspiratory muscle training versus
      isolated high-intensity inspiratory muscle training in athletes with lumbo-pelvic pain.
      Methods: A single blinded randomized clinical trial will be carried out. A total sample of 80
      athletes with lumbo-pelvic pain will be recruited and randomized into 2 groups: one group
      will be treated by isolated high-intensity inspiratory muscle training during 8 weeks, and
      another group will be treated with diaphragm visual biofeedback reeducation by
      ultrasonography during 6 weeks in conjunction with high-intensity inspiratory muscle training
      during 8 weeks. Outcome measurements will be diaphragm muscle thickness evaluated by
      ultrasonography (main outcome measurement), pain intensity, pressure pain threshold,
      disability, quality of life and respiratory parameters by spirometry, which will be assessed
      before and after intervention.
    


Intervention name(s): Diaphragm ultrasonography reeducation plus inspiratory training; Isolated inspiratory training
Intervention type(s): Other; Other
Intervention description(s): Diaphragm biofeedback reeducation plus inspiratory training during 6 weeks; Isolated high-intensity inspiratory muscle training during 8 weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Effect of Budesonide / Formoterol Combination in Repeated AMP Provocations
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 4

Summary: 
      The aim is to study whether the budesonide component within the budesonide/ formoterol
      combination inhaler has additive value in a model of "slow onset acute asthma" , namely three
      AMP provocation tests performed on one day
    


Intervention name(s): budesonide/formoterol Turbuhaler; formoterol Turbuhaler; salbutamol
Intervention type(s): Drug; Drug; Drug
Other intervention name(s): Symbicort
Intervention MeSH terms: Budesonide; Albuterol; Formoterol Fumarate
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double
Primary purpose: Treatment
Study of Combination Docetaxel and Radiotherapy With or Without Cisplatin to Treat Local Advanced Head and Neck Cancer
Condition: Head and Neck Neoplasms
MeSH terms: Head and Neck Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      To evaluate the efficacy of the concomitant combination of radiotherapy and docetaxel with or
      without cisplatin in terms of objective response rates (WHO criteria).
    


Intervention name(s): docetaxel and cisplatin; docetaxel
Intervention type(s): Drug; Drug
Intervention MeSH terms: Docetaxel
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Naproxen Sodium ER Pharmacokinetic Study
Condition: Pain
Study type: Interventional
Phase: Phase 1

Summary: 
      To determine the pharmacokinetic profile of the investigational product following dosing
      under fed conditions.
    


Intervention name(s): Naproxen sodium ER (BAYH6689); Commercial Naproxen (Aleve, BAYH6689)
Intervention type(s): Drug; Drug
Intervention description(s): Extented release Naproxen sodium (660mg) administered once a day; Immediate release Commercial Aleve (220mg) administered in a two ( 440 mg) plus one (220mg) dosing regime, 660 mg daily
Intervention MeSH terms: Naproxen
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Safety and Tolerability Study of Intracerebroventricular Administration of sNN0029 to Patients With Amyotrophic Lateral Sclerosis
Condition: Amyotrophic Lateral Sclerosis
MeSH terms: Motor Neuron Disease; Amyotrophic Lateral Sclerosis; Sclerosis
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This study is conducted to evaluate the safety and tolerability of the drug product sNN0029,
      containing the growth factor VEGF165, when administered directly into one of the fluid filled
      cavities in the brain using an implanted catheter and an implanted SynchroMed® II pump.
      Patients with Amyotrophic Lateral Sclerosis will be enrolled.
    

Detailed description: 
      Vascular endothelial growth factor (VEGF) is an endogenous human protein fundamental to the
      development of the vascular and nervous systems in the body. A role for VEGF in ALS has been
      suggested from observations in animal models of the disease as well as observations of a
      dysregulation of VEGF production in patients with ALS.

      NeuroNova intends to investigate whether intracerebroventricular administration of VEGF165 in
      the form of the drug product sNN029 can improve motor function and prolong survival in
      patients with ALS, and in this first study the safety and tolerability of treatment for 3
      months will be evaluated.

      Assessments will include:

        -  Electrocardiograms, vital signs and clinical laboratory tests

        -  Adverse events and withdrawals related to adverse events

        -  Possible pathological changes in the brain, spinal cord or retina identified through
           magnetic resonance imaging and funduscopy

        -  Possible signs of intracranial bleeding or loss of blood-brain-barrier integrity through
           measurements of bilirubin and albumin levels in cerebrospinal fluid collected through
           lumbar and cervical puncture

        -  Device performance as characterized by catheter tip placement (determined by imaging)
           and infusion accuracy (pump residual volume)

      The secondary objective of this study is:

        -  To explore the effect of ICV administration of sNN0029 on the time course of Amyotrophic
           Lateral Sclerosis related parameters including:

             -  Disease activity as measured by Amyotrophic Lateral Sclerosis Functional Rating
                Scale

             -  Quality of life as measured by the EQ-5D rating scale

        -  To explore the levels of VEGF165 in cerebrospinal fluid collected through lumbar and
           cervical puncture.
    

Intervention name(s): sNN0029; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Continuous ICV infusion at one of three dose levels; Continuous ICV infusion
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: ALS; VEGF165; Safety; Intracerebroventricular; Infusion; Implantable
Pulse Versus Continuous Cyclophosphamide for Induction of Remission in ANCA-Associated Vasculitides
Condition: ANCA Associated Systemic Vasculitis; Wegener's Granulomatosis; Microscopic Polyangiitis
MeSH terms: Granulomatosis with Polyangiitis; Microscopic Polyangiitis; Vasculitis; Systemic Vasculitis; Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      A comparison of intermittent pulsed cyclophosphamide to daily oral cyclophosphamide for the
      treatment of ANCA-associated systemic vasculitides with kidney involvement.

      Performed by the European Vasculitis Study group.
    

Detailed description: 
      The primary, ANCA-associated systemic vasculitides (AASV), including Wegener's granulomatosis
      and microscopic polyangiitis, are progressive, multisystem, autoimmune diseases which respond
      to immunosuppressive therapy. Their treatment with corticosteroids and cytotoxic drugs has
      been standardised in a first wave of studies (ECSYSVASTRIAL project), but limitations of such
      regimens include only partial efficacy and appreciable treatment-related toxicity.

      The present trial, CYCLOPS, aims to reduce the cumulative exposure to immunosuppressive drugs
      by administering cyclophosphamide (CYC) as intermittent pulses. The potential benefit of
      using CYC in this way for AASV has been demonstrated in preliminary, smaller studies.
      Patients with previously untreated AASV and, "generalised", but not life threatening, disease
      with renal involvement, will be randomised to either continuous oral CYC or intermittent
      pulse CYC. CYC will be continued until three months after remission has been achieved, with a
      minimum CYC total duration of six months and maximum duration of twelve months; both limbs
      will then receive the same maintenance regimen of azathioprine and prednisolone.

      The study will last 18 months. The primary end-point is the disease-free period, taken as the
      period of time from remission until relapse or study end; secondary end-points are adverse
      effects, cumulative damage and immunosuppressive drug exposure. 160 patients will be
      required.
    

Intervention name(s): cyclophosphamide
Intervention type(s): Drug
Intervention MeSH terms: Cyclophosphamide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Vasculitis; ANCA; Wegener's granulomatosis; Renal vasculitis; Cyclophosphamide
Drug-drug Interaction Study Between Fluconazole and Famitinib in Healthy Subjects
Condition: Tumor
Study type: Interventional
Phase: Phase 1

Summary: 
      An open-label, fixed-sequence, drug-drug interaction study to evaluate the effects of
      fluconazole on the pharmacokinetics and safety of famitinib in healthy subjects.
    


Intervention name(s): Fluconazole、Famitinib
Intervention type(s): Drug
Intervention description(s): Fluconazole, once daily on Days 12 to 24; Famitinib, once daily on Days 1 and 15
Intervention MeSH terms: Fluconazole
Intervention model: Single Group Assignment
Intervention model description: Fluconazole and famitinib interaction
Masking: None (Open Label)
Primary purpose: Basic Science
Bioequivalence Study of Levetiracetam Tablets, 750 mg of Dr. Reddy's Under Fed Conditions
Condition: Healthy
MeSH terms: Malnutrition
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to compare the single-dose relative bioavailability study of
      Levetiracetam Tablets 750 mg with Keppra® 750 mg Tablets under fed conditions.
    

Detailed description: 
      This is an open-label, randomized, single-dose 2-way crossover relative bioavailability study
      in healthy adult male volunteers under fed conditions with a washout period of 7 days.
    

Intervention name(s): Levetiracetam
Intervention type(s): Drug
Intervention description(s): Levetiracetam Tablets, 750 mg of Dr. Reddy's Laboratories Limited
Other intervention name(s): Keppra® 750 mg Tablets
Intervention MeSH terms: Levetiracetam
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Bioavailability; Crossover; Levetiracetam
A Pilot Clinical Trial With Tocotrienol on Breast Cancer
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional

Summary: 
      Tocotrienol Rich Fraction (TRF) in combination with Tamoxifen will improve breast cancer
      specific survival and recurrence free survival, in women with early breast cancer and
      estrogen receptor positive tumors.
    

Detailed description: 
      We conducted a, double-blinded, placebo controlled trial of TRF plus tamoxifen versus placebo
      plus tamoxifen in women with primary breast cancer for five years. Both the TRF and placebo
      drugs were prepared and supplied by Hovid Sdn Bhd, Malaysia. Hovid Sdn. Bhd. absolutely did
      not have any influence in the trial designing, patient recruitment, data collection, analysis
      and reporting. The placebo drug which contained soy oil without tocotrienols had similar
      appearance and taste as the TRF drug. A total of 240 women breast cancer patients were
      assigned to two groups by minimization method that balanced treatment groups. The
      intervention group was given TRF plus tamoxifen, (n = 120) while control group was given
      placebo plus tamoxifen, (n = 120). The primary end point was breast cancer specific survival,
      defined as the time from minimization to death due to breast cancer. The secondary end points
      included disease free survival, biochemical parameters, liver function and plasma levels of
      vitamin E.
    

Intervention name(s): Tocotrienol Rich Fraction (TRF); placebo plus tamoxifen
Intervention type(s): Dietary Supplement; Other
Intervention description(s): Tocotrienol Rich Fraction (200mg), daily for five years; 20mg tamoxifen daily
Other intervention name(s): Tocotrienol Rich Fraction (Hovid Sdn.Bhd)
Intervention MeSH terms: Tamoxifen; Tocotrienols; Vitamin E; Tocopherols
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Breast cancer; Tocotrienol-rich fraction with tamoxifen
Tolerability and PK of Submicron Budesonide in Children 4 to 11 Years Old With Mild-To-Moderate Stable Asthma
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 2

Summary: 
      This Phase 2 study was to investigate the tolerability of unit dose budesonide (MAP0020) at
      three doses in pediatric volunteers with a diagnosis and history of mild-to-moderate stable
      asthma and evaluate the pharmacokinetic profile of budesonide resulting from inhalation
      aerosol delivery.
    


Intervention name(s): 84ug MAP0020; 42ug MAP0020; 21ug MAP0020
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 84ug of unit dose budesonide inhalation suspension delivered by Aeroneb® Go (MAP0020) as per protocol; 42ug of unit dose budesonide inhalation suspension delivered by Aeroneb® Go (MAP0020) as per protocol; 21ug of unit dose budesonide inhalation suspension delivered by Aeroneb® Go (MAP0020) as per protocol
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: asthmatic children