bioihbjkbjnl/mcl2 huggingface dataset:
Risperidone for the Treatment of Huntington's Disease Involuntary Movements
Condition: Huntington Disease; Chorea
MeSH terms: Huntington Disease; Chorea
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to assess the safety and benefit of risperidone for the
      treatment of chorea (involuntary movements) in Huntington's disease. Risperidone is commonly
      used in clinical practice to treat chorea, however, it has not been approved by the Food and
      Drug Administration (FDA) to treat chorea. This study will examine 1) whether the
      investigators see MRI changes with risperidone treatment and 2) whether sensors applied to
      the participants body can measure chorea and detect changes in chorea.
    


Intervention name(s): Risperidone; BioStamp nPoint device
Intervention type(s): Drug; Device
Intervention description(s): capsule or tablet, 0.5 mg; MC10 has developed the BioStamp nPointTM, a FDA 510(k) cleared medical device. This multimodal, reusable and rechargeable biosensor uses flexible and stretchable electronics to enable unobtrusive wear on the body and monitoring in the home. The sensors have accelerometry, gyroscopy, and ECG/EMG capabilities. A docking station enables wireless recharging and data collection.
Intervention MeSH terms: Risperidone
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Evaluate Safety, Tolerability, and Pharmacokinetics of Single and Repeat IV Doses
Condition: Infections, Respiratory Tract
MeSH terms: Respiratory Tract Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      GSK2140944 belongs to the Bacterial Type II Topoisomerase Inhibitor (BTI) class of
      antibiotics. GSK2140944 has demonstrated in vitro and in vivo activity against Gram positive
      pathogens including methicillin resistant Staphylococcus aureus (MRSA) and Gram-negative
      pathogens associated with respiratory tract, skin and soft tissue infections including
      isolates resistant to existing classes of antimicrobials.
    

Detailed description: 
      GSK2140944 belongs to the Bacterial Type II Topoisomerase Inhibitor (BTI) class of
      antibiotics. GSK2140944 has demonstrated in vitro and in vivo activity against Gram positive
      pathogens including methicillin resistant Staphylococcus aureus (MRSA) and Gram-negative
      pathogens associated with respiratory tract, skin and soft issue infections including
      isolates resistant to existing classes of antimicrobials. This study will be the first
      administration of GSK2140944 as an intravenous (IV) formulation in humans and will be
      conducted in two (2) parts. Single IV doses will be explored in Part A and repeat IV doses
      will be explored in Part B. In addition, this study will evaluate the absolute
      bioavailability of an oral capsule formulation as compared to the IV formulation in Part A.
      Both study parts will investigate the safety, tolerability and pharmacokinetic profile of
      GSK2140944 in healthy adult subjects.
    

Intervention name(s): Part A: GSK2140944 Drug single dose of 200mg, 600mg, 1200mg, 1800 mg, and dose to be determined; Part B: GSK2140944 Repeat Drug dose of 400mg, 750mg, 1000 mg, and dose to be determined
Intervention type(s): Drug; Drug
Intervention description(s): Subjects receive a single dose of GSK2140944; Subjects will receive repeat doses of GSK2140944 BID/TID for up to 14 Days
Intervention MeSH terms: Gepotidacin
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Single (Participant)
Primary purpose: Other
Keywords: GSK2140944; antibiotics; first time in human; pharmacokinetics; intravenous; safety; absolute bioavailability; Bacterial Type II; tolerability; infection
OC000459 Bronchial Allergen Challenge
Condition: Bronchial Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 2

Summary: 
      OC0000459 reduces inflammation in the tissues in response to allergic stimuli in patients
      with asthma. This clinical trial, in mildly asthmatic patients, studies the effects of
      OC000459 and placebo on the asthmatic response to two known stimulants of the asthmatic
      response in the lungs, namely cat hair, pollen or house dust mite and methacholine.
    


Intervention name(s): OC000459; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Capsules twice daily for 15 days; Capsules twice daily for 15 days
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Asthma; bronchial allergen challenge; sputum eosinophiilia
Treatment of Insomnia and Glucose Metabolism
Condition: Sleep; Insomnia; Insulin Resistance
MeSH terms: Sleep Initiation and Maintenance Disorders; Insulin Resistance
Study type: Interventional
Phase: Phase 4

Summary: 
      Available data suggest that obtaining adequate sleep is associated with a better ability of
      the body to use carbohydrates as a source of energy and a lower risk of developing diabetes.
      The sleeping pill, Eszopiclone (Lunesta), has been approved by the Food and Drug
      Administration for the treatment of people who complain of trouble falling or staying asleep.
      This study will examine the hypothesis that the use of Eszopiclone (Lunesta) to improve the
      sleep of people with insomnia may also improve the use of sugar in their body.
    

Detailed description: 
      Study participants will complete a set of oral and intravenous glucose (sugar) tolerance
      tests, which will be performed on two separate occasions in random order: once after a week
      of treatment with Eszopiclone (Lunesta) and once again after a week of receiving placebo.
    

Intervention name(s): Eszopiclone; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Eszopiclone 3 mg by mouth daily at bedtime for 9 days; Placebo by mouth daily at bedtime for 9 days
Other intervention name(s): Lunesta
Intervention MeSH terms: Eszopiclone
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: sleep; eszopiclone; insulin secretion; insulin action; glucose tolerance
Effects of a Short-term Exercise Intervention on Sleep in Women Exposed to Trauma: A Randomized Controlled Trial
Condition: Traumatic Stress Disorder; Post Traumatic Stress Disorder; Trauma and Stressor Related Disorders; Mental Disorders; Exercise
MeSH terms: Wounds and Injuries; Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic; Mental Disorders; Trauma and Stressor Related Disorders
Study type: Interventional

Summary: 
      This study aims to test whether sleep improvements, following 6 weeks of high-intensity
      interval training exercise among adult women exposed to a traumatic event, are mediated by
      improvements in heart rate variability or decreased anxiety and hyperarousal symptoms.
    

Detailed description: 
      A total of 60 women with below-average sleep quality and physical activity levels who also
      screen positive for PTSD on the Post-traumatic Diagnostic Scale (PDS-5) will be randomized to
      either six weeks of exercise training or a waitlist control. Twenty minutes of high intensity
      interval training will be performed three times per week for six-weeks. Heart rate
      variability will be measured at rest, during, and following a cognitive task. Psychometric
      measures supported by strong validity evidence will assess self-reported anxiety and PTSD
      symptoms, and sleep quality.
    

Intervention name(s): High Intensity Interval Training (HIIT); Waitlist
Intervention type(s): Behavioral; Other
Intervention description(s): Twenty minutes of HIIT will be completed three days a week for six weeks.; Waitlist participants will be tested on the outcomes at the same time points as the treatment group.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Postpartum Sexual Function in Pregnant Women With COVID-19
Condition: COVID-19; Dyspareunia; Postpartum Period
MeSH terms: COVID-19; Dyspareunia
Study type: Observational

Summary: 
      The aim of this study is to identify women with postpartum sexual dysfunction and dyspareunia
      risk in the early period and to use the treatment and care services they need effectively.
      Our secondary aim is to reveal the difference in sexual life in the postpartum period between
      healthy pregnant women and pregnant women diagnosed with COVID-19.
    


Observational model: Ecologic or Community
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        In the reproductive age between 18-45 years old, two groups of 70 people will be selected,
        consisting of puerperant diagnosed with COVID-19 and healthy puerperant. Patients who have
        cesarean or vaginal delivery at the end of the study group, who do not have sexual
        intercourse dysfunction for another reason (such as Stage 3-4 perineal injury, vaginismus)
        will be selected.
      
Keywords: Postpartum Period; Dyspareunia; COVID-19
Validation of Promising Biomarker Assays to Assess Their Diagnostic Performance Characteristics
Condition: Acute Febrile Illnesses
Study type: Observational

Summary: 
      This project aims to evaluate the performance characteristics of rapid tests to differentiate
      bacterial from non-bacterial infection in febrile adults and children presenting at OPDs
      (outpatient departments) i.e.("fever triage assays") in three LMICs. The evaluation will
      include a different commercial biomarker combinations as well as individual biomarkers to
      assess their individual or combined value in the target population. Markers will be evaluated
      onsite in ELISA or RDT format, as appropriate. Further, this study aims to contribute to a
      centralized biobank of well-characterized specimens for use by IVD companies and academic
      institutions for the development and evaluation of emerging assays.
    


Intervention name(s): Biomarker assay
Intervention type(s): Diagnostic Test
Intervention description(s): There is no intervention on the patients but biomarker assays are being evaluated for their performance to distinguish bacterial infection from non-bacterial infections in febrile patients
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Any non-severely ill subject presenting with acute fever defined as: temperature of more
        than 38°C at initial evaluation of less than 7 days of symptoms at presentation.

        For recruitment purposes, subjects will be classified into two groups:

          -  Children 2-17 years of age

          -  Adults 18-65 years of age
      
Biospecimen description: 
      Samples of whole blood, plasma, serum and urine are stored to establish a biobank of
      characterized samples for further development and testing of diagnostic tools for
      differential diagnosis of multiple febrile diseases in endemic areas.
    
Keywords: biomarker; low and middle income countries; fever; antimicrobial resistance; diagnostic
Neurodynamic Sliding Verses Static Stretching
Condition: Healthy Individuals With Hamstring Tightness
Study type: Interventional

Summary: 
      Hamstring muscle are more likely to shorten among all biarticular muscles of human body. One
      of the many factors of hamstring tightness is increased tension in the neural structure.
      Apart from routine stretching techniques, mobilization of nervous system proves to be more
      effective. There are lot of stretching techniques available but they are more effective after
      multiple sessions. This study aims to cater the problem of hamstring tightness by neural
      sliding and static stretching in minimum sessions and compare which technique is more
      effective in resolving the issue.
    

Detailed description: 
      Randomized Controlled Trials was used to collect data. Total patients were selected in two
      group with each 31 subjects. Purposive sampling technique was used. Experimental group will
      receive routine physical therapy along with TENS, Hot pack and Neurodynamic Stretching. (For
      30 seconds, 3 times per session for 3 alternative days a week & duration of 4 weeks). Outcome
      measure will be the hamstring tightness value angle in degrees, which will be obtained with
      the help of goniometer after performing active knee extension test and active straight leg
      raise test
    

Intervention name(s): Neurodynamic Sliding; Static Stretching
Intervention type(s): Other; Other
Intervention description(s): Participants supine with their cervical and thoracic spine supported in a forward flexed position. Simultaneous hip and knee flexion will be alternated dynamically with simultaneous hip and knee extension. The therapist will change the arrangement of movement depending on the tissue resistance level.; Participent lying supine, the therapist will passively position the subject into the straight leg raise position without discomfort or pain to the point where resistance to movement will be first felt.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Other
Remodelling After Trampoline Fracture in Children
Condition: Trampoline Fracture; Tibial Fracture
MeSH terms: Fractures, Bone; Tibial Fractures
Study type: Observational

Summary: 
      The anterior tilting of the proximal tibia epiphyseal plate is a radiological tool for the
      diagnosis of suspected trampoline fracture. The tibial fracture leads to a ventral tilting of
      the tibial Plateau. This study is to document the long-term follow-up of the anterior tilt
      angle and to verify, if there is an uplift of the tibia plateau with correction of the
      anterior tilt angle to normal values (= remodelling) in order to guarantee optimal treatment
      of this rare fracture.
    


Intervention name(s): radiographs in two views of the tibia
Intervention type(s): Diagnostic Test
Intervention description(s): The anterior tilt angle of the tibia will be measured by two specialized radiologists according to a specific radiological angle measurement tool (PACS Sectra IDS7TM, Linköping, Sweden).
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Children between 2-5 years of life with the diagnosis of a trampoline fracture in the
        radiographs of the tibia in two views at the Kantonsspital Aarau, Universitätsspital Bern,
        Universitätskinderspital Zürich, UKBB Universitätsspital Basel, Kantonalspital Luzern.
      
Keywords: ventral tilting of the tibial plateau; anterior tilt angle; proximal tibia epiphyseal plate
Study to Evaluate the Efficacy and Safety of Temozolomide in Subjects With Brain Metastases of Either Malignant Melanoma, Breast, or Non-small Cell Lung Cancer (P02064)
Condition: Metastases of Central Nervous System; Melanoma; Breast Neoplasm; Carcinoma, Non-Small-Cell Lung
MeSH terms: Carcinoma, Non-Small-Cell Lung; Melanoma; Neoplasm Metastasis; Brain Neoplasms; Breast Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      The study implies a 2 step study design. Patients are enrolled into 3 separate groups for
      melanoma, breast, and non-small cell lung cancer. In the first step, 21 patients per disease
      group are enrolled. If >=2 objective responses (SD, PR, or CR) out of 21 evaluable patients
      are observed, enrollment continues for other 45 patients as a whole, where response will be
      positively evaluated if >=10 patients will respond. If <2 objective responses out of 21
      evaluable patients per disease group are observed, this(ese) group(s) will no longer be
      treated with temozolomide.
    


Intervention name(s): Temozolomide
Intervention type(s): Drug
Intervention description(s): 150 mg/m2 given once a day for 7 consecutive days (Days 1 through 7) repeated every other week until disease progression or toxicity or for a maximum of one year. After amendment, schedule was modified: a second rest week was added after the second wash-out week (Days 1 through 7, 15 through 21 every 35).
Other intervention name(s): SCH 52365
Intervention MeSH terms: Temozolomide
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Randomized Study To Evaluate Efficacy And Safety Of A Fixed Combination Therapy Of Amlodipine And Atorvastatin
Condition: Hypertension; Hypercholesterolemia
MeSH terms: Hypertension; Hypercholesterolemia
Study type: Interventional
Phase: Phase 3

Summary: 
      To assess the changes in the trough Systolic Blood Pressure (SBP) and the percent changes in
      Low Density Lipoprotein-Cholesterol (LDL-C) from baseline at Week 8 in the treatment period
    


Intervention name(s): Amlodipine 2.5mg/Atorvastatin 5mg; Amlodipine 2.5mg/Atorvastatin 10mg; Amlodipine 5mg/Atorvastatin 5mg; Amlodipine 5mg/Atorvastatin 10mg
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Single pill combination, dosed once daily for 8 weeks; Single pill combination, dosed once daily for 8 weeks; Single pill combination, dosed once daily for 8 weeks; Single pill combination, dosed once daily for 8 weeks
Intervention MeSH terms: Amlodipine; Atorvastatin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Effectiveness and Implementation of a Mental Health Intervention for ASD
Condition: Autism Spectrum Disorder
MeSH terms: Autism Spectrum Disorder
Study type: Interventional

Summary: 
      The purpose of this study is to test the effectiveness of training community mental health
      therapists to deliver a mental health intervention for ASD ("AIM HI") and study the process
      of implementing AIM HI in community mental health programs.
    

Detailed description: 
      This study is a randomized controlled effectiveness trial of AIM HI ("An Individualized
      Mental Health Intervention for ASD"), an intervention designed specifically for
      implementation in community mental health clinics, to reduce problem behavior among
      school-age children with autism spectrum disorders (ASD). Although the individual components
      of AIM HI are well-established evidence-based practice strategies and pilot study data
      indicate that child behavior problems decrease when their community mental health therapists
      deliver AIM HI, the effectiveness of the protocol has not been established. Therefore, the
      primary aims are to test the impact of training community therapists in AIM HI on child and
      family outcomes and determine how child/ family characteristics and level of therapist
      fidelity moderate treatment effects. The secondary aim is to collect initial data on
      implementation outcomes and conduct exploratory analyses to identify barriers and
      facilitators of AIM HI implementation (e.g., intervention, organization, provider
      characteristics). This study has the potential to make a significant impact by building local
      capacity to serve school-age children with ASD in routine service settings, and advancing the
      science on the effectiveness of packaging evidence-based practices (EBPs) for specific
      services settings. It will also produce generalizable knowledge about implementation that can
      be applied for this population/ setting.
    

Intervention name(s): AIM HI Training
Intervention type(s): Other
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Health Services Research
Evaluation of Locomotor Activity Before and After Total Hip Replacement in Patients With Hip Osteoarthritis.
Condition: Hip Osteoarthritis; Indication for Total Hip Replacement
MeSH terms: Osteoarthritis; Osteoarthritis, Hip
Study type: Observational

Summary: 
      The investigators believe that the application of non-linear methods of analysis using the
      ganglion and neural network technique will make it possible to analyse all of the complex
      data obtained in patients with hip osteoarthritis before and then after total hip
      replacement, and should allow us to identify a combination of objective variables to classify
      the surgery as " successful " or " unsuccessful ".

      To this end, the study will take place as follows:

      Step 1: Screening, and inclusion. Step 2: Evaluation of the hip osteoarthritis and analysis
      of locomotor activity Step 3: Total hip replacement Step 4: Clinical evaluation of locomotor
      activity carried out between 6 months and 1 year after the THR Step 5: Data analysis
    


Intervention name(s): Analysis of movement before total hip replacement; Analysis of movement after total hip replacement
Intervention type(s): Other; Other
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        hip osteoarthritis indication for total hip replacement
This Study in Healthy Men Tests How Different Doses of BI 894416 Are Taken up in the Body and How Well BI 894416 is Tolerated
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This first-in man trial is designed to investigate the safety and tolerability of BI 894416
      in healthy male subjects following oral administration of single rising doses.

      Pharmacokinetics (PK) including dose proportionality after single dosing of BI 894416 as oral
      solution will be explored, the investigation of PK of BI 894416 as tablet formulation and the
      exploration of relative bioavailability of BI 894416 as tablet formulation compared to oral
      solution.
    


Intervention name(s): BI 894416; Placebo; BI 894416 (treatment X and Z); BI 894416 (treatment Y)
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Oral solution; Oral solution; Tablet; Oral solution
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment