bioihbjkbjnl/mcl2 huggingface dataset:
A Study of rTMS for Cognitive Deficits in Chronic Patients With Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia; Cognition Disorders; Cognitive Dysfunction
Study type: Interventional

Summary: 
      In this study, we assessed the therapeutic effects and safety of left dorsolateral prefrontal
      cortex (DLPFC) high-frequency repetitive transcranial magnetic stimulation (rTMS) on negative
      symptoms of schizophrenia. We evaluated the efficacy of rTMS on cognition in patients with
      chronic schizophrenia.
    

Detailed description: 
      This is a randomized, sham-controlled, double-blinded trial. 47 patients diagnosed with
      schizophrenia on stable antipsychotic treatment were randomly assigned to active rTMS
      treatment group (n=25) or a sham rTMS treatment group (n=22). 25 patients in the active rTMS
      group received 10 Hz 110% rTMS, while 22 patients were subjected to sham rTMS, both being
      given 4-week treatment (5 days per week). Efficacy of negative symptom was assessed with the
      Scale for the Assessment of Negative Symptoms (SANS), the Positive and Negative symptom scale
      (PANSS) at baseline, the end of 4 weeks and 8 weeks. The cognitive function was assessed with
      CANTAB at baseline, the end of 4 weeks and 8 weeks .The side effects were assessed with
      Treatment Emergent Symptoms Scale at baseline and the end of 4 weeks.
    

Intervention name(s): repetitive TMS; Sham rTMS
Intervention type(s): Device; Device
Intervention description(s): Prior to each TMS administration, motor threshold was determined by stimulating the left motor strip with the lowest possible energy to produce, within 10 stimuli, at least 5 evoked potentials Z0.05 . In active rTMS, 10 Hz stimulations over left DLPFC occurred at a power of 110% of motor threshold (MT) for 5-s intervals with 30-s intertrain interval. 30 trains were administered each day (MondayFriday) for 4 consecutive weeks (total stimuli=30,000).; Sham rTMS, without stimulation
Other intervention name(s): rTMS
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: In this study, we assessed the therapeutic effects and safety of left dorsolateral prefrontal cortex (DLPFC) high-frequency repetitive transcranial magnetic stimulation (rTMS) on negative symptoms of schizophrenia. We evaluated the efficacy of rTMS on cognition in patients with chronic schizophrenia.
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Repetitive transcranial magnetic stimulation; Negative symptoms; randomized controlled trial; Schizophrenia; cognition
Changes in Habitual Physical Activity and Inactivity
Condition: Habitual Physical Activity; Sedentary Time
Study type: Interventional

Summary: 
      The purpose of this study is to determine if individuals involved in exercise training change
      habitual activity and inactivity behavior outside of exercise training. Eligible participants
      were randomly assigned to one of four groups: control, exercise training, sedentary time
      reduction, or exercise training plus sedentary time reduction. It was hypothesized that
      participants in the exercise training group will compensate for exercise training by reducing
      free-living physical activity behavior and increasing sedentary time. Participant free-living
      behavior was monitored for one week at baseline, 3, 6, 9 and 12 weeks using an activPAL
      wearable monitor.
    


Intervention name(s): exercise training; sedentary time reduction; exercsie training plus sedentary time reduction
Intervention type(s): Behavioral; Behavioral; Behavioral
Intervention description(s): 12 weeks, 5 days of week, 40 min per session of exercise training; participants provided with strategies to decrease sitting; 12 weeks of exercise training (5 days a week, 40 min per session) plus given strategies for reducing sitting time
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: physical inactivity; exercise training; sedentary time; habitual physical activity
Predicting Acute Postoperative Pain by the Preoperative Lower Back Pain
Condition: Benign Gynecological Disease
MeSH terms: Genital Diseases, Female; Back Pain; Pain, Postoperative; Low Back Pain
Study type: Observational [Patient Registry]

Summary: 
      To investigate if the level of preoperative lower back pain has the effect on the acute
      postoperative pain after gynecological laparoscopy
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        the women scheduled for elective gynecological laparoscopy in the tertiary care clinic
Dose Escalation Study of PF-07209326 in Healthy Participants and Participants With Sickle Cell Disease
Condition: Healthy; Sickle Cell Anemia
MeSH terms: Anemia, Sickle Cell
Study type: Interventional
Phase: Phase 1

Summary: 
      This Phase 1 first-in-human, first-in-patient, single ascending dose and multiple dose study
      will be a randomized, double-blind, placebo-controlled investigation of the safety,
      tolerability, and pharmacokinetics of PF-07209326 in healthy participants and participants
      with sickle cell disease.
    

Detailed description: 
      Part 1 will evaluate the safety and tolerability, pharmacokinetics and pharmacodynamics of
      single ascending doses of PF-07209326 delivered by subcutaneous injection or intravenous
      delivery in healthy volunteer participants. After establishing the safety and tolerability in
      healthy participants, Part 2 will evaluate the safety and tolerability, pharmacokinetics and
      pharmacodynamics of subcutaneously delivered multiple dose of PF-07209326 in participants
      with sickle cell disease.
    

Intervention name(s): Placebo; PF-07209326; PF-07209326
Intervention type(s): Biological; Biological; Biological
Intervention description(s): Participants will receive matching placebo; Participants will receive SC or IV single ascending doses; SCD participants will receive a multiple dose of subcutaneous PF-07209326
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Basic Science
Keywords: Safety; Tolerability; Single ascending dose; Multiple dose; Pharmacokinetics; Phase 1; First in human; First in patient
Evaluating Safety and Efficacy of Umbulizer in Patients Requiring Intermittent Positive Pressure Ventilation
Condition: Respiratory Failure; Respiratory Insufficiency; Respiratory Arrest
MeSH terms: Respiratory Insufficiency
Study type: Interventional

Summary: 
      Randomized, control crossover study comparing Umbulizer's efficacy to traditional mechanical
      ventilators
    

Detailed description: 
      Mechanical ventilators cost tens of thousands of dollars, rendering them difficult for low
      and middle income countries to procure. Given chronic shortages of these devices in places
      like Pakistan, patients are often ventilated manually with Ambu Bags for hours or days. This
      method is not suitable for long term ventilation and is extremely life threatening.

      Umbulizer seeks to reduce preventable deaths due to ventilator scarcity by providing a
      reliable alternative. The device is accurate, low-cost, and portable, and is an ideal
      solution for treating patients with respiratory diseases in low-resource settings. The
      primary objective of this study is to test efficacy and determine non-inferiority of this
      device in comparison to ventilation provided by traditional ventilators. Secondary objectives
      of this study include:

        1. Testing safety of the device for use over a predetermined period of time

        2. Evaluating patient comfort during ventilation with this device

        3. Assessing ease of use of this device for doctors and medical staff
    

Intervention name(s): Umbulizer; Traditional Mechanical Ventilator
Intervention type(s): Device; Device
Intervention description(s): Umbulizer is a reliable, user-friendly, and portable system that provides consistent air to the patient by quantitatively delivering a pre-determined tidal volume, inhale/exhale (I/E) ratio, peak pressure, and breathing rate (BPM). It can be configured to deliver either controlled ventilation or assist-controlled ventilation.; A medical device designed to artificially perform breathing functions for patients who are unable to adequately perform these functions on their own.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: respiratory disease; low resource settings; mechanical ventilation; ventilator performance; comparative study; patient safety; ease of use
ADME Study of Acoziborole in Healthy Subjects
Condition: Trypanosomiases, African
MeSH terms: Trypanosomiasis; Trypanosomiasis, African
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a single centre, open-label, single group, non-randomised, single oral dose study in
      healthy male subjects designed to assess the mass balance recovery, PK, metabolite profile
      and metabolite identification, and exploratory pharmacodynamics of acoziborole. It is planned
      to enrol 6 subjects.

      All subjects will receive an oral dose of 960 mg [14C] acoziborole on a single occasion as 4
      capsules containing a small amount of radioactivity (not more than [NMT] 1000 nCi [37 KBq]
      14C).
    

Detailed description: 
      The present study aims to further understand and quantify the absorption, distribution,
      metabolism and elimination (ADME) of acoziborole in humans through the assessment of the mass
      balance recovery after a single oral dose of [14C]-acoziborole. The routes and rates of
      elimination of [14C]-acoziborole will be determined and plasma, urine and faecal samples will
      be used for metabolic profiling and structural identification.

      Subjects will be screened for inclusion in the study up to 28 days before dosing. Subjects
      will be admitted in the evening on the day before dosing (Day 1).

      Subjects will be dosed on the morning of Day 1 following an overnight fast of a minimum of 9
      h, and will remain resident in the clinic until up to 240 h after dosing (up to Day 11).
      Subjects will return to the clinical unit for 5 additional 48 h collection periods, admitting
      to the clinical unit the evening before the collection period. The additional collection
      periods will be on Days 14 to 17, 28 to 31, 58 to 61, 88 to 91 and 118 to 121. A follow up
      call will take place 5 to 10 days post-final discharge to ensure the ongoing wellbeing of
      subjects.
    

Intervention name(s): [14C]-acoziborole capsule, 240 mg containing NMT 9.25 kBq (250 nCi) 14C
Intervention type(s): Drug
Intervention description(s): 960 mg (4 × 240 mg capsules)of acoziborole in oral and fasted condition
Other intervention name(s): no other name
Intervention model: Single Group Assignment
Intervention model description: single centre, open-label, single group, non-randomised, single oral dose study in healthy male subjects
Masking: None (Open Label)
Primary purpose: Treatment
A Pharmacokinetic Study of Omaveloxolone in Subjects With Hepatic Impairment and Normal Hepatic Function
Condition: Hepatic Impairment
MeSH terms: Liver Diseases
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will examine the pharmacokinetics (PK) of omaveloxolone following a single oral
      dose of omaveloxolone in subjects with mild, moderate, or severe hepatic impairment compared
      to healthy subjects with normal hepatic function.
    

Detailed description: 
      Study Sponsor, originally Reata Pharmaceuticals, Inc., is now Reata Pharmaceuticals, Inc., a
      wholly owned subsidiary of Biogen.
    

Intervention name(s): Omaveloxolone 50 mg capsules
Intervention type(s): Drug
Intervention description(s): Capsules containing 50 mg of omaveloxolone
Other intervention name(s): RTA 408
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: RTA 408; RTA 408 capsules; Omaveloxolone; Omaveloxolone capsules; Hepatic impairment
Validation of Indirect Calorimetry in Children Undergoing Non-invasive Ventilation
Condition: Respiratory Insufficiency in Children; Noninvasive Ventilation; Nutrition Assessment
MeSH terms: Respiratory Insufficiency
Study type: Interventional

Summary: 
      Nutritional status in critically ill pediatric patients is considered a fundamental
      prognostic factor in terms of mortality, morbidity, complications and outcome. Many studies
      report how predictive equations most commonly applied are inaccurate, therefore under or over
      estimating the body energy requirements. For this reason, actual measurement of resting
      energy expenditure (REE) through indirect calorimetry (IC) is considered to be a better
      approach.

      Currently, IC is not validated during the use of non-invasive ventilation.

      Aim of the present study is to validate the measurement of REE with IC in pediatric patients
      undergoing non-invasive ventilation through a single-limb circuit with intentional leak.
    


Intervention name(s): Indirect Calorimetry
Intervention type(s): Diagnostic Test
Intervention description(s): Performance of indirect calorimetry in Canopy mode.
Other intervention name(s): IC
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Energy Expenditure; Ventilator Weaning; Calorimetry, indirect
Neoadjuvant Bev Plus DOF vs DOF in LAGC and Its Association With Circulating Tumor Cell
Condition: Locally Advanced Gastric Carcinoma
MeSH terms: Carcinoma; Neoplastic Cells, Circulating; Stomach Neoplasms
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Background Local advanced gastric carcinoma (LAGC) is suggested to be potentially cured by R0
      resection, and neoadjuvant chemotherapy can increase the R0 resection rate but not enough.
      Bevacizumab (Bev), an anti-tumor angiogenesis monoclonal antibody, combined with chemotherapy
      has been shown effective in advanced GC. In addition, CTC has been suggested as an indicator
      of the anti-tumor drugs' efficacy. Therefore, in this study, the investigators plan to
      evaluate the efficacy and safety of neoadjuvant Bev plus docetaxel/oxaliplatin/5-FU/CF (DOF)
      versus DOF in mainly gastric antrum LAGC, and to investigate whether CTC is an effectiveness
      indicator.

      Methods 86 patients diagnosed as IIIb-IIIc GC have been enrolled and randomly assigned (1:1)
      to receive neoadjuvant Bev (5 mg/kg, d1) plus DOF (docetaxel, 75 mg/m2, iv, d1; oxaliplatin,
      85 mg/m2, iv, d1; 5-FU, iv infusion 600 mg/m2 and iv injection 400mg/m2, d1-2; CF, 200 mg/m2,
      d1 and d2) or DOF each 3-week, up to 2-4 cycles preoperation, and another 2-4 cycles
      postoperation up to total 6 cycles. The primary endpoint is R0 resection rate. CTC was
      detected every 8 weeks. All patients signed the informed consent.
    


Intervention name(s): Bevacizumab; docetaxel oxaliplatin 5-FU CF; Gastrectomy
Intervention type(s): Biological; Drug; Procedure
Intervention description(s): Bev (5 mg/kg, d1) every 3 weeks, up to 2-4 cycles preoperation, and another 2-4 cycles postoperation up to total 6 cycles.; docetaxel, 75 mg/m2, iv, d1; oxaliplatin, 85 mg/m2, iv, d1; 5-FU, iv infusion 600 mg/m2 and iv injection 400mg/m2, d1-2; CF, 200 mg/m2, d1 and d2 each 3-week, up to 2-4 cycles preoperation, and another 2-4 cycles postoperation up to total 6 cycles.
Intervention MeSH terms: Bevacizumab; Docetaxel; Oxaliplatin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Clinical Efficacy of Single-Use of Peroxyl Mouthwash for Reducing Bacteria Saliva and Bioaerosol Contamination Phase 2
Condition: Healthy
Study type: Interventional
Phase: Phase 2

Summary: 
      To evaluate the antibacterial efficacy of a commercial mouthwash containing 1.5% hydrogen
      peroxide in reducing the levels of bacteria in bioaerosols generated by dental prophylaxis.
    

Detailed description: 
      Following a washout period, subjects will return to the clinical site. A baseline microbial
      sample will be collected from the operatory's atmosphere for 30 min. prior to the study
      subject appointment by placing blood agar plates on a support board attached to the bracket
      chair tray. Upon completion of a half-mouth (e.g. right side) dental prophylaxis, each study
      subject will be instructed to rinse for one minute with 10 ml of one of the two mouthwash
      solutions (1.5% hydrogen peroxide or 0.0% hydrogen peroxide) and to expectorate all remaining
      liquid. Next, the dental prophylaxis will be completed on the other side of the mouth.
      Bioaerosol samples will be collected prior to and following rinsing on blood agar plates
      placed on a support board at a 50-degree angle to the participant's chest, on the
      participant's chest, and on the examiner's forehead. Plates will be closed and labeled. The
      plates will be transferred to the microbiology laboratory for analysis. All subjects will be
      followed for adverse events throughout the study.
    

Intervention name(s): Peroxyl Oral Product; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): mouth wash; placebo mouth wash
Other intervention name(s): Peroxyl Mouth wash
Intervention MeSH terms: Hydrogen Peroxide
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Each subject will be randomized to receive one of the two possible study products
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Mouthwash; Saliva; Bioaerosol; Bacteria; Gingivitis
Study to Compare the Safety and Anti-HIV Effect of GSK1265744 Versus Placebo in HIV-1 Infected Adults (ITZ112929)
Condition: Infection, Human Immunodeficiency Virus
MeSH terms: Acquired Immunodeficiency Syndrome; HIV Infections
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this randomized, double-blinded study is to test the safety of GSK1265744 and
      how well it works on reducing the amount of HIV in the blood. It will also look at how people
      react to and how a human body uses GSK1265744. This study will compare the effects of
      GSK1265744 and placebo.

      The study will consist of 1 or 2 parts to look at doses of GSK1265744. About 8 people will
      take part in Part 1 of the study receiving dose A. If additional dosing information is needed
      after Part 1, about 6 people will take part in Part 2 of the study receiving dose B.
    


Intervention name(s): GSK1265744 30mg; Placebo; GSK1265744 5mg
Intervention type(s): Drug; Drug; Drug
Intervention description(s): GSK1265744 30 mg; Placebo to match GSK1265744; GSK1265744 5mg
Intervention MeSH terms: Cabotegravir
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: HIV; naive; Phase II; integrase inhibitor; GSK1265744; newly diagnosed; pharmacokinetics; AIDS; integrase; HIV Infections; Treatment naive
Autonomic Dysfunction in Resistant Hypertension
Condition: Hypertension, Resistant to Conventional Therapy
MeSH terms: Hypertension
Study type: Observational [Patient Registry]

Summary: 
      The contribution of this study is the unedited evaluation of the circadian autonomic profiles
      of resistant hypertension with and without white-coat response.
    

Detailed description: 
      All patients were submitted to office blood pressure measurement, Ambulatory blood pressure
      monitoring and 24-hour Holter monitoring.

      Baseline blood samples for the measurement of glycemia (mg/dL), total cholesterol (mg/dL),
      LDL cholesterol (mg/dL), triglycerides (mg/dL), creatinine (mg/dL), serum uric acid, serum
      sodium, serum potassium, plasma aldosterone concentration (PAC) and plasma renin activity
      (PRA) were collected at 08:00 after overnight fasting.
    

Observational model: Cohort
Sampling method: Probability Sample
Study population: 
        Forty-four resistant hypertension subjects, regularly followed up at the cardiovascular
        clinical pharmacology out-patients' clinic, and who complied with pharmacological
        prescription for hypertension, were recruited to participate in this transversal and
        observational study.
      
Keywords: Resistant hypertension; White-coat phenomenon; Heart rate variability; autonomic activity
Gastric Cancer Surgery in Elderly Patients
Condition: Gastric Cancer
MeSH terms: Stomach Neoplasms
Study type: Observational

Summary: 
      Gastric cancer is most frequent after the fifth decade of life. Surgical risk is higher in
      aged population because of general health condition may affect the postoperative result. Aim
      of the study was to identify risk factors for post-operative mortality in octogenarian
      patients who underwent surgery for gastric cancer.
    

Detailed description: 
      236 patients (181: 80-85 years old and 55: >85 years old) underwent surgery for gastric
      cancer at the Sant'Orsola-Malpighi University Hospital in Bologna between 2010 and 2015. The
      variables of the two groups of patients were compared.
    

Intervention name(s): Gastric resection
Intervention type(s): Procedure
Intervention description(s): Partial gastrectomy with jejunal anastomosis," "total gastrectomy," "gastroenterostomy without gastrectomy" or "other" (palliative surgery).
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        236 patients (181: 80-85 years old and 55: >85 years old) underwent surgery for gastric
        cancer at the Sant'Orsola-Malpighi University Hospital in Bologna between 2010 and 2015.
Efficacy and Safety of Grass Pollen Sublingual Immunotherapy
Condition: Allergic Rhinoconjunctivitis
MeSH terms: Conjunctivitis; Conjunctivitis, Allergic
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The study is assessing efficacy and safety of three different dosage regimens of grass pollen
      sublingual immunotherapy in adult patients suffering from grass pollen related
      rhinoconjunctivitis.
    

Detailed description: 
      Patients with seasonal grass pollen related rhinoconjunctivitis will be randomized to one of
      four treatment groups at 41 centres in Europe. Each treatment group will consist of
      approximately 150 patients and 150 patients will be randomized to a placebo group. The study
      will consist of a screening phase, a treatment phase and a variable maintenance period.
    

Intervention name(s): Oralgen; grass pollen extract
Intervention type(s): Drug; Drug
Intervention description(s): Patients will receive drops of grass pollen immunotherapy sublingually; Patients will receive matching placebo sublingually
Other intervention name(s): grass pollen extract; Placebo control
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: randomised; double-blind; placebo-controlled; efficacy and safety; Oralgen® Grass Pollen; allergic rhinoconjunctivitis; Allergy; Rhinoconjunctivitis; Immunotherapy; Grass pollen extract