bioihbjkbjnl/mcl2 huggingface dataset:
Ecopipam Tablets to Study Tourette Syndrome in Children and Adolescents - Open Label Extension
Condition: Tourette Syndrome in Children; Tourette Syndrome in Adolescence
MeSH terms: Tourette Syndrome; Syndrome
Study type: Interventional
Phase: Phase 2

Summary: 
      This study was an international, multicenter, open-label, long term extension study
      evaluating the safety of ecopipam tablets for the treatment of children and adolescent
      subjects with Tourette Syndrome.
    

Detailed description: 
      This was an international, multicenter, open-label, long term extension study to evaluate the
      safety of ecopipam tablets for the treatment of pediatric subjects (aged ≥6 to ≤18 years at
      Baseline) with Tourette Syndrome. Participants who completed the Phase 2b, randomized,
      double-blind, efficacy and safety study (EBS-101-CL-001) without major reportable protocol
      deviations, and who met all the inclusion/exclusion criteria for this study were eligible to
      participate in this study. All participants were titrated to a target dose of 2 mg/kg/day as
      participants rolled over from the Phase 2b double-blind efficacy and safety study were
      tapered off study drug to maintain the blind from that study. Participants were to complete
      study visits every month for 1 year. Follow-up visits were conducted 7 and 14 days after the
      last dose of the study drug and a follow-up phone call was conducted 30 days after the last
      dose of study drug
    

Intervention name(s): Ecopipam
Intervention type(s): Drug
Intervention description(s): Ecopipam HCl 12.5-, 37.5-. 50-, 75- and 100-mg tablets; 2 mg/kg/day target dose; oral administration daily in evenings.
Intervention MeSH terms: Ecopipam
Intervention model: Single Group Assignment
Intervention model description: Open Label
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Tourette Syndrome
To Assess the Efficacy of Investigational Product on the Neuropathic Pain in Individuals Suffering From Type II Diabetes Mellitus.
Condition: Diabetic Neuropathies; Insomnia Due to Medical Condition
MeSH terms: Neuralgia; Diabetic Neuropathies; Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      this study is to be carried out to examine the effect of Investigation product on diabetic
      individuals suffering from diabetic neuropathic pain.
    


Intervention name(s): NeuropAWAY; Microcystalline cellulose
Intervention type(s): Other; Other
Intervention description(s): 2 capsules thrice daily to be taken half an hour prior to meal.; 2 capsules thrice daily to be taken half an hour prior to meal.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Efficacy of Docetaxel, Capecitabine, Cisplatin, and Bevacizumab in Patients With Unresectable Advanced Gastric Cancer
Condition: Advanced Gastric Cancer
MeSH terms: Stomach Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine whether docetaxel, capecitabine, cisplatin, and
      bevacizumab are effective in the treatment of unresectable advanced gastric cancer.
    

Detailed description: 
      In our previous phase II study of neoadjuvant docetaxel, capecitabine and cisplatin
      chemotherapy, patients with unresectable gastric cancer because of invasion to adjacent
      organs or metastasis to para-aortic lymph nodes received benefit from neoadjuvant
      chemotherapy. Based on these results and reports that bevacizumab enhances response rate, we
      planned docetaxel, capecitabine, cisplatin, and bevacizumab as neoadjuvant chemotherapy for
      patients with local invasion or para-aortic node metastasis alone.
    

Intervention name(s): Docetaxel, Capecitabine, Cisplatin, Bevacizumab
Intervention type(s): Drug
Intervention description(s): Bevacizumab 7.5mg/kg IV (D1) Docetaxel 60 mg/m2 IV (D1) Cisplatin 60 mg/m2 IV (D1) Xeloda 1,875 mg/m2/day/bid PO (D1-D14)
Intervention MeSH terms: Bevacizumab; Docetaxel; Capecitabine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Advanced gastric cancer; Neoadjuvant; Bevacizumab
Reduced Clavulanate Formulation of Amoxicillin-Clavulanate in Children 6-23 Months With Acute Otitis Media
Condition: Acute Otitis Media
MeSH terms: Otitis; Otitis Media
Study type: Interventional
Phase: Phase 3

Summary: 
      To evaluate the safety profile of amoxicillin-clavulanate potassium containing a reduced
      concentration of clavulanate potassium, 600 mg/21.5 mg/5 mL (a ratio of 28:1), administered
      at 90/3.2 mg/kg/day (formulation 1) or at 80/2.85 mg/kg/day (formulation 2) in two divided
      doses for 10 days. Investigators will focus on the proportion of subjects who develop
      protocol-defined diarrhea and proportion who develop diaper dermatitis that occasions the
      prescription of antifungal medication.
    

Detailed description: 
      Amoxicillin-clavulanate potassium has been shown to be efficacious in eradicating causative
      pathogens in acute otitis media (AOM) with resulting high clinical cure rates at
      end-of-treatment (85%). However, relatively high rates (~25%) of clinically significant
      diarrhea have been reported, the occurrence of which has been directly related to the
      clavulanate potassium component of the drug combination. A reduced concentration of
      clavulanate potassium in the drug formulation would be expected to have an improved safety
      profile regarding the occurrence of diarrhea. This study will examine whether the
      concentration of the clavulanate potassium component of amoxicillin-clavulanate potassium
      could be reduced in the treatment of children 6 months through 23 months of age diagnosed
      with AOM using stringent criteria. A total of 75 participants (n=75) with AOM will receive
      amoxicillin-clavulanate potassium (600 mg/21.5 mg/5 mL; 28:1) administered at 90/3.2
      mg/kg/day (formulation 1) or at 80/2.85 mg/kg/day (formulation 2) in two divided doses for 10
      days.

      The primary outcome measure will be rates of clinically significant diarrhea and diaper
      dermatitis. These rates will be compared with the rate observed in our previous studies of
      AOM in children who received amoxicillin-clavulanate potassium (600 mg/42.9 mg/5 mL; 14:1)
      administered at 90/6.4 mg/kg/day in two divided doses for 10 days.

      A subset of this group will have pharmacokinetic studies performed. Each participant that
      agrees will have a single blood draw (n=50). Investigators will analyze amoxicillin and
      clavulanate potassium in the blood samples using validated methods.
    

Intervention name(s): Amoxicillin-Clavulanate potassium
Intervention type(s): Drug
Other intervention name(s): Augmentin
Intervention MeSH terms: Amoxicillin; Clavulanic Acid; Clavulanic Acids; Amoxicillin-Potassium Clavulanate Combination
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: ear infections; antibiotics; antibiotic resistance; pediatrics; infants; children; amoxicillin-clavulanate
Safety and Tolerability of Repeated Subcutaneous Injections of CAD106 in Mild Alzheimer's Patients.
Condition: Alzheimer Disease
MeSH terms: Alzheimer Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      This study will evaluate the safety and tolerability of repeated subcutaneous injections of
      CAD106 in patients with mild Alzheimer's disease.
    


Intervention name(s): Placebo; CAD106
Intervention type(s): Biological; Biological
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Active immunization; Alzheimer disease; Antibody; Central Nervous System Diseases; Neurodegenerative diseases; Vaccine
The Effect of Positioning With Material and Hand-Face Maneuver
Condition: Stress; Position
Study type: Interventional

Summary: 
      The study was administered in a randomized controlled experimental design to evaluate the
      effects of material positioning and hand-face maneuver on physiological parameters and stress
      symptoms in preterm newborns with gestational weeks 28 to 32. The sample of the study
      consisted of 60 preterm infants who met the selection criteria in newborn intensive care unit
      between September 2018 and July 2020.The newborns in the control group (n=30) were given a
      "nesting with a rolled up blanket" position, as in the routine of the ward. The Experimental
      Group1 (n=30) was given positions using a "positioner" and the same newborns (Experimental2)
      was given positions using "positioner and hand-face maneuver" on the second day of the study.
    

Detailed description: 
      The universe of the study consisted of preterm newborns patients who met the selection
      criteria in newborn intensive care unit.The research was planned as a randomized controlled
      experimental study. In order for the groups to be distributed homogeneously, the order
      produced by a computer program (http://www.randomizer.org/) was used. Patients who meet the
      inclusion criteria and agree to participate in the study assigned to the experimental and
      control groups according the randomization list. The control variable of the study is
      demographic characteristics of the baby. The dependent variables of the study are
      physiological parameters, newborn position assesment tool score and newborn stress scale
      score In the research, "Information and follow-up form" prepared by the researcher in line
      with the literature was used as data collection tools. Newborn Position Assesment Tool and
      Newborn Stress Scale were also used
    

Intervention name(s): Tortoise Positioning Material Group
Intervention type(s): Device
Intervention description(s): Preterm infants were placed in the nest with positioning material and placed in lateral and prone positions The positioning material and hand-face maneuver were applied together to the preterm infants in the Positioning Material Group 2, and they were given lateral and prone positions in this way
Other intervention name(s): Control Group
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: The Effect of Positioning with Material and Hand-Face Maneuver on Physiological Parameters and Stress Symptoms in Preterm Newborns
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: preterm; position; stress; physiological parameters
Study to Demonstrate the Efficacy, Safety and Tolerability of Intravenous Secukinumab up to 52 Weeks in Subjects With Active Psoriatic Arthritis
Condition: Psoriatic Arthritis
MeSH terms: Arthritis; Arthritis, Psoriatic
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study was to provide up to 52 weeks of efficacy, safety and tolerability
      data to support registration of intravenous (i.v.) secukinumab (Initial dose of 6 mg/kg at
      Baseline (BSL) followed thereafter with 3 mg/kg administered every four weeks) in patients
      with active psoriatic arthritis (PsA) despite current or previous Non-steroidal
      anti-inflammatory drugs (NSAIDs), Disease-modifying antirheumatic drugs (DMARDs) and/or
      anti-tumor necrosis factor (TNF) therapy.
    

Detailed description: 
      This multicenter study used a randomized, double-blind, placebo-controlled, parallel-group
      design. A screening (SCR) period running up to 10 weeks before randomization was used to
      assess subject eligibility followed by a treatment period of 52 weeks.

      At baseline, 381 patients with active psoriatic arthritis were randomized to one of the two
      treatment groups in a 1:1 randomization:

      Group 1: Approximately 190 patients with active psoriatic arthritis; These patients received
      secukinumab 6 mg/kg i.v. at BSL, followed by the administration of secukinumab 3 mg/kg i.v.
      every four weeks starting at Week 4.

      Group 2: Approximately 190 patients with active psoriatic arthritis; These patients received
      i.v. placebo at BSL and at Weeks 4, 8, and 12, followed by the administration of secukinumab
      3 mg/kg i.v. every four weeks starting at Week 16.

      Study consisted of 4 periods: a screening period (up to 10 weeks), treatment period 1 (total
      duration of 16 weeks) and treatment period 2 (total duration of 36 weeks) followed by a
      safety follow up period of 8 weeks after the end of treatment visit (i.e., Week 52).

      Primary endpoint analysis will be performed with Week 16 data (last patient completing
      Treatment period 1 (Week 16). Long-term efficacy and safety assessments will be performed up
      to Week 52.
    

Intervention name(s): AIN457 6 mg/kg i.v.; Placebo; AIN457 3 mg/kg
Intervention type(s): Drug; Drug; Drug
Intervention description(s): AIN457 6 mg/kg delivered by i.v. infusion; Matching placebo to AIN457 i.v. infusion; AIN457 3 mg/kg delivered by i.v. infusion
Other intervention name(s): secukinumab; secukinumab
Intervention MeSH terms: Antibodies, Monoclonal
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Active Psoriatic Arthritis; Intravenous secukinumab; PsA
Oxygen Peripheral Saturations and Lung Surgery
Condition: Pulmonary Surgical Procedures; Recovery Period
Study type: Observational

Summary: 
      The purpose of this study is to compare the ability of two peripheral and non invasive
      devices to detect hypoxic events during one-lung ventilation and during the early
      postoperative period. One device measures regional cerebral oxygenation and the other
      muscular oxygenation. These two devices are compared to non invasive arterial saturation
      (SpO2), which is the gold standard.
    

Detailed description: 
      Lung surgery is often complicated by hypoxic evants :

        -  during one-lung ventilation which leads to changes about ratio in ventilated and
           perfused lung areas. This blood flow redistribution promotes shunt with a decreased
           arterial oxygenation and possible hypoxemia.

        -  during the postoperative period.

      Common measure of arterial saturation through SpO2 may miss a great number of hypoxic events
      with regional impact because a significant decrease in SpO2 occurs for an arterial pressure
      in oxygen below 60 mmHg. Currently, cerebral and somatic saturation can be monitored
      non-invasively and continuously via optical sensors applied to the right and left forehead
      and to the thenar eminence. These devices may help clinicians in the detection of such
      hypoxemic events.
    

Intervention name(s): Monitoring of tissular oxygenation
Intervention type(s): Device
Intervention description(s): Equanox: cerebral oxygenation by spectroscopy, near-infrared through forehead and noninvasive devices
Inspectra: tissular oxygenation by spectroscopy, near-infrared through thenar and noninvasive device
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients submitted for scheduled lung surgery requiring one-lung ventilation
      
Keywords: perioperative surgery; regional oxygenation; hypoxemia; brain hypoxemia; spectroscopy, near-infrared
Safety and Efficacy Study of Insulin Lispro Versus Insulin Aspart in Participants With Type 2 Diabetes on Insulin Pump Therapy
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 3

Summary: 
      This study will provide information on the use of insulin lispro and insulin aspart in
      insulin pumps in participants with type 2 diabetes.
    

Detailed description: 
      This study will provide clinical information on the use of insulin lispro in continuous
      subcutaneous insulin infusion (CSII) in participants with type 2 diabetes. This study is
      designed to allow comparison of the 2 rapid-acting insulin analogs, with regard to their
      efficacy and safety, when used as a pump insulin therapy in this participant population. Each
      participant will be randomized to 1 of the 2 sequence groups in a 1:1 ratio and randomization
      will be stratified according to screening A1C (less than or equal to 8.0% or greater than
      8.0%) and thiazolidinedione (TZD) use (yes or no). The study design includes the following
      periods: Screening/Randomization, Treatment Period 1 (16 weeks), and Treatment Period 2 (16
      weeks).
    

Intervention name(s): Insulin Lispro; Insulin Aspart
Intervention type(s): Drug; Drug
Intervention description(s): Insulin lispro (100 U/mL) administered by CSII pump; Insulin aspart (100 U/mL) administered by CSII pump
Other intervention name(s): Humalog; LY275585; Novolog
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Insulin Aspart; Insulin Lispro
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: diabetes; type 2 diabetes; insulin pump; continuous subcutaneous insulin infusion; CSII; A1C
Youth Mayo Clinic Anxiety Coach Pilot Study
Condition: Anxiety
MeSH terms: Anxiety Disorders
Study type: Interventional

Summary: 
      This research study aims to test the feasibility and effectiveness of using the Mayo Clinic
      Anxiety Coach smartphone app as an addition to traditional therapy for the treatment of
      anxiety disorders in youth, particularly those youth who may have limited access to mental
      health treatment in the traditional clinical setting.
    

Detailed description: 
      This research study aims to test the feasibility and effectiveness of using the Mayo Clinic
      Anxiety Coach smartphone app as an addition to traditional therapy for the treatment of
      anxiety disorders in youth, particularly those youth who may have limited access to mental
      health treatment in the traditional clinical setting. Therapist will provide CBT to patients
      with infrequent face-to-face contact and then will examine the acceptability, ease of use and
      need for contact.
    

Intervention name(s): Mayo Clinic Anxiety Coach
Intervention type(s): Device
Intervention description(s): Mayo Clinic Anxiety Coach is a smartphone application based on cognitive-behavioral treatment for anxiety disorders (i.e., exposure-based therapy) that can be used as 1) a stand-alone treatment requiring minimal provider contact, and 2) an augmentation of face-to-face treatment that increases clinician fidelity and patient adherence to evidence-based treatment. The design of Anxiety Coach is based on evidence and theory suggesting that information and communication technologies (ICTs) are well-suited for encouraging behavior change through 1) scheduled reminders to engage in therapeutic exercises, 2) point of performance support, 3) individually tailored information, 4) real-time symptom assessment, and 5) readily accessible asynchronous communication.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Other
Keywords: Anxiety; Social Anxiety; Social Phobia; Separation Anxiety; Generalized Anxiety; GAD; Phobia; Panic; Agoraphobia; Obsessive Compulsive Disorder; OCD; Child; Adolescent; Smartphone; Teen; Youth
Efficacy and Akathisia Incidence of Slow Infusion Metoclopramide
Condition: Akathisia; Nausea
MeSH terms: Psychomotor Agitation; Nausea
Study type: Interventional

Summary: 
      Study Objective:

      The purpose of this study is to compare the effects of metoclopramide administration in bolus
      versus slow infusion medications in ED patients complaining of nausea for the determination
      of the therapeutic effect and prevention of akathisia.

      Methods:

      This was a prospective, randomized, double-blind trial. The investigation was held between 01
      March 2007 and 01 May 2008, in the Emergency Department of Pamukkale University Faculty of
      Medicine. The patients with moderate to severe nausea randomized and divided into two groups
      as for the previously planned administration type of drug. Ten mg metoclopramide was
      administered in one group with slow infusion (SIG) in 15 minutes, via 2 minutes bolus
      infusion (BIG) into the other group. Whole procedure was observed, akathisia and nausea
      scores and vital changes were recorded.
    


Intervention name(s): metoclopramide 10 mg
Intervention type(s): Drug
Intervention MeSH terms: Metoclopramide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: metoclopramide; akathisia; nausea; vomiting; antiemetic; improvement of nausea
Drug-Drug Interaction of Lopinavir/Ritonavir on Pitavastatin
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 4

Summary: 
      This is a Phase 4, single center, open label, fixed-sequence, 2-way drug-drug interaction
      study.
    

Detailed description: 
      This is a Phase 4, single center, open label, fixed-sequence, 2-way drug-drug interaction
      study.

      Each subject will qualify for entry into the study not more than 30 days prior to admission
      into the clinical unit. Subjects will check into the clinical unit on Day -1 for baseline
      assessments. There will be one treatment period, with each subject receiving a once daily
      dose of pitavastatin 4 mg on Days 1 through 5 and Days 20 through 24 and a twice daily dose
      of lopinavir/ritonavir 400 mg/100 mg (two 200 mg/50 mg tablets per dose) on Days 9 through
      24. Pitavastatin will be administered under fasting conditions in the morning and
      lopinavir/ritonavir will be administered under fasting conditions in the morning and evening.
    

Intervention name(s): Pitavastatin (NK-104); Lopinavir/ritonavir
Intervention type(s): Drug; Drug
Intervention description(s): pitavastatin (NK-104) 4 mg once daily (QD); lopinavir/ritonavir 800 mg/200 mg
Other intervention name(s): Livalo; Kaletra
Intervention MeSH terms: Ritonavir; Lopinavir; Pitavastatin
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Healthy Volunteers