bioihbjkbjnl/mcl2 huggingface dataset:
Adalimumab in Combination With Ciprofloxacin/Placebo Treatment of Perianal Fistulas in Crohn's
Condition: Crohn's Disease With Perianal Fistulas
MeSH terms: Crohn Disease; Rectal Fistula; Fistula
Study type: Interventional
Phase: Phase 3

Summary: 
      To assess whether a combination of ciprofloxacin and adalimumab is more effective than
      adalimumab alone for the treatment of perianal fistulas in Crohn's disease
    

Detailed description: 
      Dutch multicenter, randomized, double-blind study with two arms. 146 patients will be
      included.
    

Intervention name(s): adalimumab; ciprofloxacin
Intervention type(s): Drug; Drug
Intervention description(s): 24 weeks: 160 mg, 80 mg, and than 40mg every 2 weeks; 12 weeks; daily 2 x 500mg
Other intervention name(s): Humira; Cipro
Intervention MeSH terms: Ciprofloxacin; Adalimumab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Perianal fistulas; Crohn's disease
Treatment Effects on Platelet Calcium in Hypertensive and Depressed Patients
Condition: Depression; Hypertension
MeSH terms: Hypertension; Depression
Study type: Interventional
Phase: Phase 4

Summary: 
      This study aims to determine if treatment with an SSRI antidepressant medication, paroxetine,
      is associated with cellular calcium response to serotonin, platelet serotonin receptors, and
      improvement in mood in depressed patients with or without hypertension. It is hypothesized
      that platelets of hypertensive patients with depressive symptomatology with be
      hyper-responsive to serotonin. Additionally, treatment with an SSRI antidepressant is
      expected to produce a down-regulation of the serotonin receptor with an associated reduction
      in platelet cytosolic calcium response as well as improved mood.
    


Intervention name(s): paroxetine; ongoing psychological screening
Intervention type(s): Drug; Behavioral
Intervention MeSH terms: Paroxetine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Serotonin, Hypertension, Depression
Olanzapine for the Prevention of Postoperative Nausea and Vomiting
Condition: Postoperative Nausea
MeSH terms: Nausea; Vomiting; Postoperative Nausea and Vomiting
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Nausea and vomiting (PONV) remain a common problem in surgical units. Even after two or three
      prophylactic antiemetic interventions, patients with all four of the Apfel risk factors for
      PONV have an estimated 30 to 40% chance of suffering PONV. Olanzapine as an antiemetic
      represents a new use of an antipsychotic drug.
    

Detailed description: 
      Aim of the Research, to compare the effects of oral 10 and 5 mg Olanzapine for the Prevention
      of Postoperative Nausea and Vomiting
    

Intervention name(s): Placebo; 5 mg Olanzapine Tablets; 10 mg Olanzapine Tablets
Intervention type(s): Drug; Drug; Drug
Intervention description(s): oral Placebo tablets one-hour preoperatively; oral 5 mg Olanzapine tablets one-hour preoperatively; oral 10 mg Olanzapine tablets one-hour preoperatively
Other intervention name(s): zyprexa; zyprexa
Intervention MeSH terms: Olanzapine
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: All patients will receive oral 10, 5 mg Olanzapine or placebo one hour preoperative
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
A Study of the Safety and Efficacy of Ustekinumab in Adolescent Patients With Psoriasis (CADMUS)
Condition: Psoriasis
MeSH terms: Psoriasis
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a study of the safety and efficacy of ustekinumab (CNTO 1275) in adolescent patients
      with moderate to severe psoriasis.
    

Detailed description: 
      This is a randomized (drug assigned by chance), double-blind (a medical research study in
      which neither the researchers nor the participants know what treatment the participant is
      receiving), placebo-controlled, parallel (a medical research study comparing the response in
      two or more groups of participants receiving different treatments), multicenter of
      ustekinumab in adolescent participants with moderate to severe psoriasis. The total duration
      of study will be 60 weeks. The study will consists of 2 parts; a Screening period and a
      Treatment period. In treatment period participants will receive either ustekinumab half
      standard dosage, ustekinumab standard dosage or Placebo. Participants receiving ustekinumab
      half standard dosage and ustekinumab standard dosage at Week 0, will receive placebo at Week
      12 and participants receiving placebo at Week 0 will be randomly assigned to either
      ustekinumab half standard dosage or ustekinumab standard dosage Weeks 12, 16, 28, and 40.
      Primarily efficacy will be evaluated by physician's global assessment (PGA) score of cleared
      or minimal disease. Participants' safety will be monitored throughout the study.
    

Intervention name(s): Ustekinumab - Half-Standard Dosage; Ustekinumab - Standard Dosage; Placebo
Intervention type(s): Drug; Drug; Other
Intervention description(s): Ustekinumab 0.375 mg/kg, 22.5 mg, or 45 mg based on body weight, administered subcutaneously (under the skin) at Weeks 0, 4, 16, 28, and 40.; Ustekinumab 0.75 mg/kg, 45 mg, or 90 mg based on body weight administered subcutaneously at Weeks 0, 4, 16, 28, and 40.; Placebo administered subcutaneously at Weeks 0 and 4 or at Week 12.
Intervention MeSH terms: Ustekinumab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Ustekinumab; Injection; CNTO 1275; Stelara; Pediatric psoriasis; Adolescents
A Study to Evaluate the Safety, Immune Response, and Efficacy of Gardasil (V501, qHPV) in Mid-Adult Women (V501-019)
Condition: Healthy Adult Female Participants; Prevention; Papillomavirus Infection; Human Papillomavirus Recombinant Vaccine Quadrivalent, Types 6, 11, 16, 18
MeSH terms: Papillomavirus Infections
Study type: Interventional
Phase: Phase 3

Summary: 
      This study was conducted to assess the safety, immunogenicity, efficacy and long-term
      effectiveness of a vaccine being evaluated for the prevention of human papillomavirus (HPV)
      infection and disease in mid-adult women.
    

Detailed description: 
      The Base study vaccination period (V501-019) encompassed Day 1 through Month 7, during which
      time participants received randomly assigned, blinded Gardasil™ (V501, qHPV vaccine) or
      placebo at Day 1, Month 2 and Month 6. The Base study follow-up period continued through
      approximately Month 48.

      The base study was extended in protocol V501-019-10 (EXT1). Participants who received placebo
      and participants who received only 1 dose of qHPV vaccine in the Base Study were offered a
      complete, open-label, 3-dose qHPV vaccine regimen (administered at EXT1 Day 1, Month 2 and
      Month 6). Participants who received only 2 doses of qHPV vaccine in the base study were
      offered a single additional dose of qHPV vaccine (administered at EXT1 Day 1). Participants
      were followed to EXT1 Month 7.

      A Long Term Follow-Up (LTFU) extension study V501-019-21 (EXT2) was added to observe the long
      term safety, effectiveness, and immunogenicity of qHPV vaccine in approximately 1,600 women
      who participated in the Base Study at sites in Colombia. Data were collected over a period of
      6-10 years following participant's enrollment in the original Base Study.
    

Intervention name(s): Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine; Comparator: Placebo
Intervention type(s): Biological; Biological
Intervention description(s): qHPV intramuscular injection in three 0.5 mL doses over 6 months in the Base Study or EXT1; Placebo intramuscular injection in three 0.5 mL doses over 6 months.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Oral Contraceptive and Strength Training
Condition: Healthy
Study type: Interventional

Summary: 
      Cross sectional study investigating the effect of strength training in users and non-users of
      oral contraceptives (OC) (2nd generation OC)
    


Intervention name(s): no oral contraceptive and training; oral contraceptive and training
Intervention type(s): Other; Other
Intervention description(s): 10 weeks of training in a group of oral contraceptive users; 10 weeks of training in a group of users of oral contraceptives
Intervention MeSH terms: Contraceptive Agents; Contraceptives, Oral
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: Cross sectional study with 16 in each group.
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: exercise; oral contraceptive; strength training
Long-term Follow-up of Immunogenicity of a Single Dose of Japanese Encephalitis Chimeric Virus Vaccine (JE-CV) in Toddlers
Condition: Encephalitis; Japanese Encephalitis
MeSH terms: Encephalitis, Japanese; Encephalitis
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a long-term follow-up of the persistence of immune response in participants who
      previously received a single dose of JE-CV at age 12 to 18 months in Study JEC02
      (NCT00735644) . No vaccination was administered during the present long-term follow-up study.

      Primary Objective:

        -  To describe the yearly persistence of humoral immune response to Japanese encephalitis
           after a single dose of JE-CV
    

Detailed description: 
      Persistence of immune response will be determined in participants who previously received a
      single dose of JE-CV at age 12 to 18 months in Study JEC02 (NCT00735644). No vaccination will
      be given in this study.
    

Intervention name(s): Blood sample; JE-CV administered in Study JEC02
Intervention type(s): Other; Biological
Intervention description(s): Blood sample for immunogenicity assessment; Participants received a single dose of JE-CV at 12 to 18 months of age in Study JEC02. No vaccination was administered in Study JEC05
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Encephalitis; Japanese Encephalitis; Japanese Encephalitis Chimeric Virus Vaccine; Toddlers
A Study of AL-794 to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single and Multiple Doses, and the Antiviral Activity of Multiple Doses in an Influenza Challenge Study
Condition: Influenza
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 1

Summary: 
      This randomized, double-blind, placebo-controlled, 4 part study will assess the safety,
      tolerability, pharmacokinetics and antiviral activity of orally administered AL-794 in
      healthy volunteers (HV).
    


Intervention name(s): AL-794; Placebo/Vehicle
Intervention type(s): Drug; Other
Intervention description(s): Suspension vehicle without active drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Impact of Enhanced External Counterpulsation on Vascular Hemodynamics and Status
Condition: Coronary Heart Disease
MeSH terms: Heart Diseases; Coronary Disease; Coronary Artery Disease; Myocardial Ischemia
Study type: Interventional

Summary: 
      The present study aimed to investigated the effect of Enhanced External Counterpulsation
      (EECP) on vascular hemodynamics and atherosclerosis, and the underlying shear stress related
      mechanisms
    

Detailed description: 
      Patients with coronary heart disease will be randomized into two groups: standard medical
      treatment and standard medical treatment plus EECP intervention. Hemodynamic parameters,
      vascular status and function will be measured.
    

Intervention name(s): EECP; Medical therapy
Intervention type(s): Device; Drug
Intervention description(s): Enhanced external counterpulsation (EECP) is a technique for assisting the circulation by decreasing the afterload of the left ventricle and augmenting the diastolic pressure externally by applying a negative pressure to the lower extremities during cardiac systole. EECP therapy is done by sequential inflation of 3 sets of cuffs wrapped around the lower extremities during diastole and deflation of the cuffs during systole. EECP enhances the aortic diastolic blood flow and coronary perfusion, leading to increased arterial wall shear stress in a pulsatile manner.; Guideline- driven standard medical treatment including statins,antiplatelet drugs（aspirin or Clopidogrel ）, anti-ischemic drugs （Nitroglycerin）
Other intervention name(s): Enhanced External Counterpulsation; Guideline- driven medical therapy
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Parallel: Patiants with coronary heart disease are assigned to two groups in parallel for the duration of the study.
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Coronary Heart Disease; Atherosclerosis; Vascular Endothelium; Counterpulsation, External
Experimental Evaluation of Back Braces for the Treatment of Spinal Deformity Produced With 3D Printing Technology
Condition: Adolescent Idiopathic Scoliosis; Osteogenesis Imperfecta
MeSH terms: Scoliosis; Osteogenesis Imperfecta; Congenital Abnormalities
Study type: Interventional

Summary: 
      The proposed investigation is a pilot study that involves pediatric patients affected by
      spinal deformity (Adolescent Idiopathic Scoliosis and Osteogenesis Imperfecta).

      The main goal is to evaluate the acceptability, the safety and the overall satisfaction of
      the patients wearing the back braces produced with an innovative methodology using 3D
      printers, compared to the current braces manufactured with a production model based on
      thermoforming, that has well-established clinical efficacy.
    


Intervention name(s): Scoliosis back brace
Intervention type(s): Device
Intervention description(s): The patients will use the traditional brace, if not already in use, for 2 weeks and then they will wear a 3D printed back brace for the following 2 weeks. Both the braces will be worn for the amount of hours per day prescribed by the physician.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Device Feasibility
Keywords: scoliosis; spinal deformity
Development of a Clinical Prediction Rulefor Neck Manipulation
Condition: Mechanical Neck Pain
MeSH terms: Neck Pain
Study type: Interventional

Summary: 
      Cervical spine manipulation has been shown to be helpful for some patients with neck pain.
      This study sought to determine factors which were predictive of which patients with neck pain
      would benefit from manipulation.
    


Intervention name(s): Manipulation
Intervention type(s): Procedure
Intervention description(s): Single level cervical spine joint manipulation
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Comparison of Postoperative Analgesic Effect of Intrathecal Clonidine and Fentanyl Added to Bupivacaine in Patients Undergoing Cesarean Section
Condition: Post Operative Pain
MeSH terms: Pain, Postoperative
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Objective :To compare the analgesic effect of intrathecal clonidine and fentanyl as an
      additive to bupivacaine in patients undergoing cesarean section .

      Methods:Following Ethics Committee approval and informed patients consent, Ninety patients
      18-45 yr old ASA physical status I or II, scheduled for cesarean section under spinal
      anesthesia, were studied in a prospective, double-blinded, randomized way. The patients were
      randomly allocated to one of three groups of 30 each. The clonidine group (groupC) received
      bupivacaine 10mg combined with 75microgram clonidine preservative free ,the fentanyl group
      (group F) received bupivacaine 10mg combined with25microgram fentanyl and the placebo group
      (group P) received bupivacaine 10mg combined with 0.5ml distilled water intrathecally . Time
      to first requirement of analgesic supplement, Sensory block onset time, maximum sensory level
      , onset of motor block, duration of blockade, hemodynamics variables, the incidence of
      hypotension, ephedrine requirements, bradycardia ,hypoxemia [Saturation of peripheral oxygen
      (SpO2)<90], postoperative analgesic requirements and Adverse events, such as sedation,
      dizziness , Pruritus and postoperative nausea and vomiting were recorded. Patients were
      instructed preoperatively in the use of the verbal rating scale (VRS) from 0 to 10 (0no pain,
      10maximum imaginable pain) for pain assessment. If the VRS exceeded four and the patient
      requested a supplement analgesic, diclofenac Na supp 100 mg was to be given for
      post-operative pain relief as needed . For breakthrough pain(VRS >4) if time of
      administration of diclofenac Na less than 8h,Pethidine 25 mg IV was given.
    


Intervention name(s): distilled water; Clonidine; Fentanyl
Intervention type(s): Drug; Drug; Drug
Intervention description(s): The placebo group (group P) received bupivacaine 10mg combined with 0.5ml distilled water intrathecally .; The clonidine group (group C) received bupivacaine 10mg combined with 75 microgram clonidine intrathecally .; The Fentanyl group (group F) received bupivacaine 10mg combined with 25 microgram fentanyl intrathecally .
Intervention MeSH terms: Clonidine; Fentanyl
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Fentanyl; clonidine; intrathcal; bupivacaine
Role of Frontal Cortex in the Pathophysiology of Gilles de la Tourette Syndrome (GTS)
Condition: Tourette Syndrome
MeSH terms: Tourette Syndrome; Syndrome
Study type: Interventional

Summary: 
      Tourette's syndrome (TS) is a debilitating and severe syndrome whose pathophysiology remains
      unclear.

      In order to precise the cortical regions involved in the generation of tics, investigators
      will realize an electroencephalogram (EEG) recording in the frontal cortex of TS patients in
      ecological conditions (EEG-holter). Activity changes will be correlated with event markers of
      tics and neurovegetative parameters. Statistical analyses will be compared between epochs of
      EEG recording with tics and without tics. The aim is to define the cortical regions involved
      in the genesis of tics in order to consider new targets for cortical stimulation.
    

Detailed description: 
      Gilles de la Tourette syndrome (GTS) is a childhood-onset disorder characterized by the
      presence of multiple motor tics and at least one vocal tic often associated with psychiatric
      co-morbidity. The expression of tics range from brief, recurrent and non-rhythmic motor or
      vocal actions (simple tics) to complex motor or vocal sequences (complex tics). The
      pathophysiology of tics is not yet fully understood. Recent imaging data suggest that the
      pattern of functional connectivity in cortico-basal ganglia networks is disrupted in GTS
      patients and could reflect a defect in brain maturation. However, regions involved in the
      immediate genesis of tics remains unknown since it is difficult to capture on line the
      cortical changes associated with tic generation using imaging techniques due to moving
      artefacts. Moreover, tics are much more frequent in everyday life conditions than in the
      artificial conditions of a laboratory. The aim is to study cortical activity changes
      occurring before tic occurrence by using long duration recording of encephalographic activity
      (EEG) in ecological conditions through Holter EEG techniques (24h recordings). Recordings
      will be performed in 15 patients with a severe form of Tourette's syndromes. EEG changes will
      be correlated to event markers, voluntary monitored by patients or automatically recorded
      (accelerometers for motor tics). EEG epoch centered on tics will be compared to similar
      epochs without tics. The occurrence of tics will also be correlated with neurovegetative
      markers of emotions such as RR interval ECG variability and skin resistivity changes. The
      ultimate goal of this project is to define a potential therapeutic target of tics for chronic
      cortical stimulation.
    

Intervention name(s): Electroencephalographic recordings
Intervention type(s): Procedure
Intervention description(s): 24 hours of electroencephalographic recordings (EEG-Holter) of prefrontal activity of Tourette's syndrome (TS) patients in ecological conditions.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Evaluation of a New Treatment for Migraine Attacks
Condition: Migraine
MeSH terms: Migraine Disorders
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate the efficacy of a novel therapy for treatment of
      migraine, pain reduction and relief of associated symptoms during ongoing migraine attacks,
      and presence of a preventive effect post treatment.
    


Intervention name(s): Inactive Migraine Medical Device; Migraine Medical Device
Intervention type(s): Device; Device
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Baxdrostat Bioavailability and Bioequivalence Study
Condition: Hypertension
MeSH terms: Hypertension
Study type: Interventional
Phase: Phase 1

Summary: 
      The goal of this study was to compare the characteristics of a new tablet formulation versus
      an oral solution of CIN-107 (baxdrostat) in terms of CIN-107 levels over time in the blood
      and to compare the effect of food on these parameters in healthy volunteer participants who
      received the CIN-107 tablet under fed versus fasted conditions.
    

Detailed description: 
      The goals of this study were to:

        1. To assess the safety and tolerability of single doses of CIN-107 tablet and oral
           solution in healthy participants.

        2. Compare CIN-107 levels over time in the blood in participants after dosing between a
           tablet formulation of CIN-107 as compared to the oral solution.

        3. Compare the CIN-107 levels over time in the blood in participants following dosing with
           a CIN-107 tablet after a meal versus in the fasted state.

      Participants took either the oral solution or a tablet of CIN-107 and had their safety and
      blood levels of CIN-107 measured over several days following administration of CIN-107 tablet
      either in the fasted state or after a meal. The CIN-107 blood levels over time were compared
      between the groups given either the oral solution or the tablet and between the group given
      the CIN-107 tablet with a meal versus in the fasted state.
    

Intervention name(s): baxdrostat (formerly CIN-107) oral solution
Intervention type(s): Drug
Intervention description(s): 5 mg single dose of baxdrostat given as either a solution or tablet in either the fed or fasted state, depending on the arm of the study
Other intervention name(s): baxdrostat (formerly CIN-107) tablet
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Randomized Crossover between 1) oral solution, 2) tablet in the fasted state, and 3) tablet in the fed state
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: pharmacokinetics (PK); food effect; bioavailability