bioihbjkbjnl/mcl2 huggingface dataset:
Study to Assess the Safety, Tolerability, Pharmacokinetic (PK) and Pharmacodynamic (PD) Effects of EVP-6308 and the Potential of EVP-6308 to Affect the PK Properties of the Antipsychotic Regimen in Subjects With Schizophrenia Currently Receiving Stable Treatment With up to 2 Atypical Antipsychotics
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a randomized, double-blind, placebo-controlled, sequential cohort, ascending oral
      dose study of the safety, tolerability, pharmacokinetics, and pharmacodynamics of EVP-6308
      administered for 14 days in subjects with schizophrenia who are on a stable anti-psychotic
      regimen.
    


Intervention name(s): Drug: EVP-6308; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Arms 1, 2, 3; Arm 4
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Phosphodiesterase 10 inhibitor
Ascending Dose Study of HU6 in Healthy Volunteers
Condition: NASH - Nonalcoholic Steatohepatitis
MeSH terms: Fatty Liver; Non-alcoholic Fatty Liver Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a single ascending dose trial in healthy volunteers. The study will be conducted in
      up to 7 cohorts. Upon review of the safety and PK data, it may be decided to expand the
      current cohort versus dose escalate to the next cohort. In addition, the sponsor may elect
      not to enroll all 7 cohorts based on safety and/or PK and/or PD data.
    

Detailed description: 
      This is a single ascending dose trial in healthy volunteers. The study will be conducted in
      up to 7 cohorts. Upon review of the safety and PK data, it may be decided to expand the
      current cohort versus dose escalate to the next cohort. In addition, the sponsor may elect
      not to enroll all 7 cohorts based on safety and/or PK and/or PD data.

      Up to 74 subjects will be enrolled to allow for replacement subjects, if deemed necessary.
      Fewer subjects may be enrolled if not all cohorts are utilized due to identification of the
      MTD in an earlier cohort.

      Double-blind dosing will occur in cohorts 1 through 7. In these cohorts, 6 subjects will
      receive HU6 and 2 will receive matching placebo.
    

Intervention name(s): HU6
Intervention type(s): Drug
Intervention description(s): HU6 is designed to reduce the steatosis, inflammation, fibrosis and hepatocyte injury in Noncirrhotic Nonalcoholic Steatohepatitis (NASH)
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: The study will be conducted in one phase: a single dose, dose escalation phase in up to 7 cohorts
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: NASH
Experiment 2: Understanding Liver Fat Metabolism
Condition: Fatty Acid Oxidation
Study type: Interventional

Summary: 
      There is a largely unsubstantiated thought in the literature that dietary unsaturated enter
      oxidation pathways preferentially compared to saturated fatty acids. This study is
      undertaking a direct comparison of the oxidation of dietary saturated and unsaturated fatty
      acids.
    

Detailed description: 
      Provided subjects meet the inclusion criteria, then at least one week after the screening
      visit volunteers will then undertake the first two 'study days'. There will be two study days
      on separate occasions that will be up to 3 weeks apart. Each study day will be approximately
      7 hours in duration. On each study day participants will be given a standardised 'test' meal
      that contains specially labelled fat molecules (stable-isotope tracer) and then repeated
      breath and blood samples will be taken over the course of the next 6 hours. The test meal
      consumed on each 'study day' will be identical in composition with only the specially
      labelled fat molecules being different (either unsaturated or saturated fat) and these will
      be given in a random order.
    

Intervention name(s): Dietary fatty acid partitioning
Intervention type(s): Other
Intervention description(s): There is no intervention as such, just a physiological assessment of the partitioning and oxidation of two different types of dietary fatty acids
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Randomised cross-over
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
This Study Tests the Safety of Inhaled BAY1237592, How the Drug is Tolerated and How it Effects Patients With High Blood Pressure in the Arteries of the Lungs in the Two Different Disease Groups Pulmonary Arterial Hypertension (PAH) and Chronic Thromboembolic Pulmonary Hypertension (CTEPH)
Condition: Hypertension, Pulmonary
MeSH terms: Hypertension, Pulmonary; Pulmonary Arterial Hypertension; Hypertension
Study type: Interventional
Phase: Phase 1

Summary: 
      In this trial the effects of the inhaled drug BAY1237592 will be studied in patients with
      high blood pressure in the pulmonary blood vessels due to Pulmonary Arterial Hypertension
      (PAH) and due to Chronic Thromboembolic Pulmonary Hypertension (CTEPH). Pulmonary
      hypertension is characterized by the elevation of pressure in the pulmonary arteries (PAP)
      and of the pulmonary vascular resistance (PVR) leading to increased workload of the right
      chamber of the heart to eject blood against this elevated resistance. The goal of this study
      is to measure the safety and tolerability of the drug as well as the reduction of the PVR at
      different doses

      In Part A patients without specific treatment for PH (untreated patients) will be tested. In
      Part B also patients stably pre-treated with specific PH drugs will be studied in combination
      with the new inhaled drug
    


Intervention name(s): BAY1237592
Intervention type(s): Drug
Intervention description(s): Oral inhalation with dry powder inhaler, single dose.
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: PAH; CTEPH; pulmonary arterial hypertension; chronic thromboembolic pulmonary hypertension
Evaluation of the Efficacy and Safety of PiQo4 System for the Treatment of Pigmented Lesions
Condition: Pigmentation
Study type: Interventional

Summary: 
      A total of at least 25 healthy subjects at a single site, aged 21-70 years old with
      congenital or acquired challenging/resistant, age/sun-related flat and benign facial
      pigmentation with or without hand pigmentation who wish to improve their skin appearance.
    


Intervention name(s): PiQo4 Laser System
Intervention type(s): Device
Intervention description(s): PiQo4 Laser System for treatment of pigmented lesions
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Cosmesis, Patient Satisfaction and Quality of Life After da Vinci Single Site and Multiport Laparoscopic Cholecystectomy
Condition: Symptomatic Gallbladder Disease
MeSH terms: Gallbladder Diseases
Study type: Interventional

Summary: 
      Prospective, randomized , multicenter study comparing cholecystectomy performed with da Vinci
      Single Site Instruments™ to multi-port (four ports) laparoscopy
    

Detailed description: 
      Prospective, randomized , multicenter study comparing cholecystectomy performed with da Vinci
      Single Site Instruments™ to multi-port (four ports) laparoscopy.

        -  The primary objective of this study is to evaluate cosmesis, patient satisfaction and
           quality of life after robotic- assisted single incision cholecystectomy procedure using
           da Vinci Single- Site Instruments™ in comparison to a multiport laparoscopic approach.

        -  The secondary objective of this study is to assess the peri-operative clinical outcomes
           of robotic- assisted single incision cholecystectomy with da Vinci Single - Site
           Instruments™ in comparison to a multiport laparoscopic approach.

        -  The third objective of this study is to evaluate hernia incidence at 1 year and 18
           months after surgery
    

Intervention name(s): Cholecystectomy
Intervention type(s): Procedure
Intervention description(s): Gallbladder removal
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: robotic single-site cholecystectomy; laparoscopic cholecystectomy; cosmesis; quality of life
Alterations in Cognitive Function and Cerebral Blood Flow After Conversion From Immediate Release Tacrolimus to Slow Release Envarsus
Condition: End Stage Renal Disease
MeSH terms: Kidney Diseases; Kidney Failure, Chronic
Study type: Observational

Summary: 
      The purpose of this study is to learn if conversion from immediate release tacrolimus to
      Envarsus improves cerebral blood flow, brain blood flow response to exercise, and cognition.
    

Detailed description: 
      Each patient will have two study assessments: one at baseline and another one at 12 weeks
      after the baseline assessment. Each assessment may be divided into 2 visits to accommodate
      the MRI and TCD (Transcranial Doppler ultrasound). Detailed medical history will be extracted
      from the patients' medical records, interviews and questionnaires. We will obtain brain MRI
      (without gadolinium contrast) in enrolled patients. Neuropsychological test (NP) tests will
      include a standard battery to detect subclinical changes in cognition which can be missed by
      screening tests like the mini mental state exam.
    

Intervention name(s): Envarsus; Tacrolimus
Intervention type(s): Drug; Drug
Intervention description(s): Patients will then be randomized in the ratio of 2:1 with 20 being in the study arm and 10 in the control arm. Envarsus will be prescribed by the transplant team per conversion guidelines. The transplant team will monitor drug levels, per the dosing guidelines.; The patient's physician will prescribe drug according to standard practice.
Other intervention name(s): Prograf
Intervention MeSH terms: Tacrolimus
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients will be recruited from the KUMC kidney transplant clinic. Both male and female
        kidney transplant recipients aged 18 to 85 will be included.
      
Biospecimen description: 
      Approximately 6 teaspoons of blood will be collected at each of the two visits and stored for
      future research (optional). This blood will be stored in the University of Kansas Kidney
      Institute Freezer.
    
Keywords: End Stage Renal Disease
Trial of Nano-hydroxyapatite-Containing Toothpastes for Relief of Dentin Hypersensitivity
Condition: Dentin Sensitivity
MeSH terms: Dentin Sensitivity; Hypersensitivity
Study type: Interventional

Summary: 
      Subjects will be enrolled into 3 balanced groups each using a different strength toothpaste.
      Dental hypersensitivity (DHS) will be assessed at study start, midway and study end.
    

Detailed description: 
      This study is a double-blind, randomized, placebo-and positive-controlled, stratified
      parallel group clinical trial. The three groups will be randomly assigned to use one of three
      test toothpastes having an identical base formulation but containing respectively either 0%
      nano-hydroxyapatite (HAP) (placebo), 15% nano-HAP or 5% KNO3 (positive control). All dental
      examinations for data collection will be conducted by the same Clinical Examiner.
    

Intervention name(s): Placebo; 15% nano-HAP toothpaste; 5% KNO3 toothpaste
Intervention type(s): Other; Device; Device
Intervention description(s): 0% nano-HAP toothpaste; Toothpaste with identical base formulation as the placebo containing 15% nano-HAP; Toothpaste with identical base formulation as the placebo containing 5% KNO3
Other intervention name(s): Placebo toothpaste; 15 % nano-Hydroxyapatite toothpaste; 5% Potassium Nitrate Toothpaste
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Evaluation of an Algorithm for Length Based Weight Estimation in Comparison to Known Devices
Condition: Weight-Estimation
MeSH terms: Body Weight
Study type: Observational

Summary: 
      The purpose of this prospective single center study is to investigate if a developed
      algorithm is more accurate than the Broselow Tape (BT). For this study 500 patients are
      required to collect anonymized data (length, weight, age, anaesthesia material used during
      anaesthesia) for achieving a power of 80% during statistical analysis. The main hypothesis
      ist that the algorithm has a better accuracy than the BT.
    

Detailed description: 
      This prospective single center study is performed at the university children's hospital
      zurich. Patients planned for surgery in general anaesthesia with intubation, aged 0 to 16
      years and with a body length suitable for the emergency tapes can be included in this study.
      Patient and parental information is performed during the pre-anaesthetic visit.

      After written consent the patient will be included. Patient ́s length and weight will be
      measures earliest one day before data collection. Data collection during anaesthesia has no
      influence on the daily anaesthesia routine and has no impact on patient safety and
      anaesthesia. Patient's data is made anonymous for further inspection. Data is documented in
      Microsoft Excel and statistical analysis calculated with SPSS.

      500 patients are needed for a power of 80%. Primary outcome parameter is length- based weight
      estimation, secondary outcome parameters are length-based age estimation and the correctness
      of recommended anaesthesia material (endotracheal tube, laryngeal mask, oropharyngeal mask
      and face mask). Both tools (algorithm and BT) will be compared with each other regarding
      primary and secondary outcome parameters.
    

Intervention name(s): Accuracy of an algorithm and the Broselow Tape
Intervention type(s): Device
Intervention description(s): Computer based comparison of the two devices based on collected patient data
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Pediatric patients planned for elecitve surgery in general anaesthesia
      
Keywords: Broselow Tape; Weight estimation; Patient safety
Effects Of Calisthenic Exercises On Physical Fitness Among School Going Children
Condition: Healthy Life Style; Physical Fitness
Study type: Interventional

Summary: 
      The study will be conducted to determine the effects of Calisthenic Exercise on Physical
      fitness among school going children .
    

Detailed description: 
      Callisthenic Exercises has proven effective in gaining strength, endurance and balance in
      adults and children age (11 to 17 years) but still evidence is less as compared to children
      age (8 to 13 years). calesthenics can be perform in door so for children who mostly stay t
      home or on gadget if perform these activities may improve their physical fitness
    

Intervention name(s): Calisthenic Exercises
Intervention type(s): Other
Intervention description(s): Bunny Jumps, Bear Crawls, Bear Crawls, Bird Dog . these intervention were used
Other intervention name(s): Calisthenic Exercises (Animal Style)
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Other
Study to Evaluate the Safety and Pharmacokinetics of MEDI9090 in Subjects With Advanced Solid Tumors
Condition: Advanced Solid Tumors
MeSH terms: Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      This is an open-label, study of MEDI9090 to evaluate the safety, tolerability, PK,
      immunogenicity, and antitumor activity of MEDI9090 in adult subjects with advanced solid
      tumors.
    


Intervention name(s): MEDI9090; Durvalumab
Intervention type(s): Biological; Biological
Intervention description(s): MEDI9090 will be administered by IV infusion; Durvalumab as a single agent will be administered by IV infusion after patients have completed the prescribed doses of Medi9090.
Intervention MeSH terms: Durvalumab
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Advanced Solid Tumor; Immunotherapy; MEDI9090; MEDI4736; Durvalumab
Adolescent Cancer Telemedicine for Pain Management
Condition: Cancer
Study type: Interventional

Summary: 
      Pain in adolescents undergoing treatment for cancer is a common problem, often related to
      treatment or to the cancer itself. Due to increasing outpatient-based cancer treatment, the
      burden of care and pain management has shifted to the home environment. Yet, there are
      limited interventions that target the management of pain at home. Adolescence is marked by
      increased need for independence and social integration, both of which can be impaired by pain
      or fear of pain. To address unique needs during this developmental period, this study will
      test a telemedicine program to enhance pain knowledge and pain control strategies in
      adolescents ages 12-21 years who are undergoing treatment for cancer.

      Fifty-six teens will be randomized to an intervention or wait-list control condition.
      Patients randomized to the waitlist control condition will receive the intervention following
      completion of the waitlist condition. The intervention will consist of four weekly 30-45
      minute telemedicine (online via videoconferencing platform) sessions with a trained social
      work or psychology provider. Sessions will focus on pain psychoeducation, coping tools,
      communication, and stress management. Participants will complete online questionnaires
      assessing pain coping, pain management, and pain-related impairment at pre-intervention,
      post-intervention, and 1- and 2-month follow-up.
    


Intervention name(s): Telemedicine Pain Management Intervention (immediate group); Telemedicine Pain Management Intervention (waitlist group, intervention administered following 4-week waitlist period)
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Four weekly telemedicine pain management sessions with a trained provider. Intervention will be delivered via video conferencing platform, and each session will last between 30 and 45 minutes. Intervention topics will include: pain psychoeducation, pain coping tools, pain communication, and pain-related stress management.; Four week waitlist period during which participants receive treatment as usual. Following the waitlist period, participants will receive the telemedicine pain management intervention:
Four weekly telemedicine pain management sessions with a trained provider. Intervention will be delivered via video conferencing platform, and each session will last between 30 and 45 minutes. Intervention topics will include: pain psychoeducation, pain coping tools, pain communication, and pain-related stress management.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Waitlist control group receives intervention following waitlist period.
Masking: None (Open Label)
Primary purpose: Supportive Care
A Study for Patients With Osteoporosis
Condition: Osteoporosis
MeSH terms: Osteoporosis
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to compare the effect of injectable teriparatide to intranasal
      salmon calcitonin on lumbar spine bone mineral density, in the treatment of Chinese patients
      with established osteoporosis
    


Intervention name(s): Teriparatide; Salmon Calcitonin
Intervention type(s): Drug; Drug
Intervention description(s): Subcutaneous, 20 micrograms/day, 24 weeks; Intranasal, 200 International Units (IU)/day, 24 weeks
Other intervention name(s): LY333334; Forteo; Forsteo
Intervention MeSH terms: Teriparatide; Calcitonin; Salmon calcitonin; Calcitonin Gene-Related Peptide; Katacalcin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Depression and Immune Function in Multiple Sclerosis (MS)
Condition: Multiple Sclerosis; Depressive Disorder, Major
MeSH terms: Multiple Sclerosis; Sclerosis; Depressive Disorder; Depressive Disorder, Major
Study type: Observational

Summary: 
      Depression is one of the most common symptoms of multiple sclerosis (MS) with a life-time
      prevalence of major depressive disorder (MDD) of up to 50%. Depression occurs more frequently
      in MS than in other chronic diseases including other neurological and inflammatory disorders
      and may contribute to lower quality of life, cognitive problems, difficulties at work, and
      poorer long term health outcomes. Despite its clinical relevance, the biological mechanisms
      which may be responsible for the high risk for MS patients to develop depression are unknown.

      In this observational study, investigators explore the molecular mechanisms responsible for
      the impaired regulation of immune cells in relapsing-remitting (RR) MS patients with
      depression. Investigators will compare the molecular and phenotypical profile of immune cells
      obtained from RRMS patients with clinical depression (n=50), matched MS patients who do not
      suffer from depression (n=50) as well as matched healthy controls (n=50) and matched patients
      with depression but without a comorbid neurological disorder (n=50).
    


Intervention name(s): No intervention
Intervention type(s): Other
Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Patients will be recruited at neurological outpatient clinics and neurologcial clinics of
        the Charité and neurologists' medical practices.