bioihbjkbjnl/mcl2 huggingface dataset:
Multi-Channel Gastric Electrical Stimulation for the Treatment of Gastroparesis
Condition: Gastric Stasis
MeSH terms: Gastroparesis
Study type: Interventional

Summary: 
      Investigate the safety and efficacy of multi-channel gastric electrical stimulation in the
      treatment of patients with severe diabetic gastroparesis refractory to standard therapy.
    

Detailed description: 
      Evaluation of severe symptom control of nausea, vomiting, postprandial fullness, early
      satiety, bloating and discomfort related to drug refractory gastroparesis present as a GI
      complication in diabetic patients. External gastric pacemaker system will be placed at the
      same time of implantation of Enterra (internal gastric stimulator-permanent device) to assess
      symptoms, quality of life improvement and investigate the changes in gastric emptying time in
      diabetic gastroparesis.
    

Intervention name(s): Enterra Multi-Channel Phased Gastric Pacemaker (MGP-1)
Intervention type(s): Device
Intervention description(s): Multi-Channel Phased Gastric Pacemaker (MGP-1)
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Role of Colonic Events on Metabolism and Appetite Control: A Synbiotic Approach
Condition: Obesity; Metabolic Syndrome
MeSH terms: Metabolic Syndrome
Study type: Interventional
Phase: Early Phase 1

Summary: 
      The purpose of the study is to evaluate food factors related to colonically derived
      regulation of glucose metabolism (and related parameters) and satiety using a semi-acute meal
      study in healthy subjects as experimental model.
    


Intervention name(s): test meal; reference
Intervention type(s): Other; Other
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Laser Versus Ultrasonic Lithotripsy in Percutaneous Nephrolithotomy for Staghorn Stones
Condition: Kidney Stones
MeSH terms: Kidney Calculi
Study type: Interventional

Summary: 
      This study will be conducted to compare the results of Laser and ultrasonic lithotripsy in
      disintegration of staghorn stones during percutaneous nephrolithotomy.
    

Detailed description: 
      Patients with complete staghorn stones who are eligible to percutaneous nephrolithotomy (PNL)
      will be randomized between two groups.

      Group 1: will undergo Laser lithotripsy during PNL Group 2: will undergo ultrasonic
      lithotripsy during PNL
    

Intervention name(s): Laser; Ultrasonic
Intervention type(s): Device; Device
Intervention description(s): Patients will undergo laser lithotripsy durin PNL; Patients will undergo ultrasonic lithotripsy during PNL
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Staghorn stones; Percutaneous nephrolithotomy; Laser; Randomized trial; Lithotripsy
Single Ascending Dose (SAD) and Multiple Ascending Dose (MAD) Study of M5049 in Healthy Participants
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The study will evaluate the safety, tolerability, Pharmacokinetic (PK), Pharmacodynamics
      (PD), and explore the food effect of M5049 in healthy male and female participants.
    


Intervention name(s): M5049; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Participants will receive single ascending oral dose of M5049 in Part A. Participants will receive multiple ascending oral dose of M5049 once daily for 14 days or twice daily for 13 days followed by a single dose on Day 14 in the morning in Part B. Participants will receive a single oral dose of M5049 under fed conditions in Part C.; Participants will receive placebo matched to M5049.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Other
Keywords: Pharmacokinetics; M5049
Study of Ataluren in ≥2 to <5 Year-Old Male Participants With Duchenne Muscular Dystrophy
Condition: Duchenne Muscular Dystrophy
MeSH terms: Muscular Dystrophies; Muscular Dystrophy, Duchenne
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a Phase 2, multiple-dose, open-label study evaluating the safety, pharmacokinetics
      (PK), and pharmacodynamics (PD) of ataluren in participants aged ≥2 to <5 years old with
      Duchenne muscular dystrophy (DMD) caused by a nonsense mutation in the dystrophin gene.
    

Detailed description: 
      In nonsense mutation DMD (nmDMD), early start of treatment is important and necessary and,
      therefore, it is relevant to understand the correct and tolerable dose in this age group,
      particularly since ataluren is dosed by weight. This study included a 4-week screening
      period, a 52-week treatment period (the first 4 weeks of which included PK parameters), and a
      4-week follow-up period for participants who completed the treatment period (60 weeks total
      duration). The objective of the extension period (treatment period after PK parameters have
      been completed) was to assess the long-term safety of chronic administration of ataluren in
      this participant population.
    

Intervention name(s): Ataluren
Intervention type(s): Drug
Intervention description(s): White to off-white powder for oral suspension.
Other intervention name(s): PTC124; Translarna
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Sex Differences in Vascular Markers of Stroke Risk
Condition: Stroke
MeSH terms: Stroke
Study type: Observational

Summary: 
      The purposes of this study are to quantify and compare vascular function in men and women,
      and to determine the effect of age, race-ethnicity, cardiovascular risk factors, biological
      markers and hormonal markers on vascular measures to establish gender-specific models.
    

Detailed description: 
      Men and women with stroke have different risk factor profiles. Women tend to develop stroke
      risk factors, subclinical disease, and have vascular events following menopause, presumably
      related to the depletion of estrogen. Men, however, tend to develop vascular disease at a
      younger age. Sex differences in subclinical disease are poorly understood. Identification of
      subclinical disease could lead to more aggressive interventions to prevent stroke and other
      vascular events.

      The objectives of this study are to quantify and compare vascular function in men and women
      by measuring carotid atherosclerosis, endothelial dysfunction, and ankle-brachial index and
      then to determine the effect of age, race-ethnicity, cardiovascular risk factors, biological
      markers and hormonal markers on these vascular measures to determine gender-specific models.
      The aims of this project are to determine if middle-aged men and women at risk for stroke
      have differences in functional and structural vascular assessments, and to develop
      comprehensive vascular health profiles in men and women.

      In this trial, researchers will use a cross-sectional design to study gender differences in
      vascular functions and other vascular risk factors in 150 women and 100 men with 1 or more
      cardiovascular risk factors but without evidence of stroke, heart disease, or peripheral
      vascular disease. Participants will be divided in two age groups: 45 to 54 and 55 to 64 and
      will be followed for two years for vascular outcomes, such as stroke, transient ischemic
      attack or TIA, or acute coronary syndromes.

      Information from this study will help develop a comprehensive gender-specific model of
      subclinical disease, discover novel biological and vascular markers for stroke, and provide
      critical data to be used in future studies aimed at slowing progression of vascular
      dysfunction and preventing stroke.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Participants will be recruited from primary care clinics, which may include internal
        medicine, family practice, and obstetrics/gynecology within the Wake Forest University
        health system.
      
Biospecimen description: 
      RNA and DNA samples collected
    
Keywords: stroke; vascular marker; stroke risk; risk factors; sex differences
Study to Assess Safety and Efficacy of DF01 in Reducing Prolonged Labor
Condition: Pregnancy; Labor
Study type: Interventional
Phase: Phase 2

Summary: 
      The study is a Proof-of-concept study to evaluate if DF01 can prevent protracted labor. Time
      to delivery will be measured from the time of at least 3 cm cervix dilatation and 3
      contractions of minimum one minute's duration/10 minutes.
    


Intervention name(s): DF01; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Once daily s.c. injections from approximately 3-7 days before expected delivery (maximum 2 weeks before) until delivery (maximum 2 weeks after expected delivery); Once daily s.c. injections from approximately 3-7 days before expected delivery (maximum 2 weeks before) until delivery (maximum 2 weeks after expected delivery)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: prolonged labor
Safety and Immunogenicity of Trivalent Subunit Inactivated Flu Vaccine Administered to Healthy Children and Adolescents 3 to 17 Years of Age
Condition: Seasonal Influenza
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 3

Summary: 
      This study will evaluate the safety and immunogenicity in healthy children and adolescents
      after one or two IM dose(s) of trivalent subunit inactivated flu vaccine.
    


Intervention name(s): TIV; TIVf; Comparator TIV
Intervention type(s): Biological; Biological; Biological
Intervention description(s): Investigational egg-derived trivalent subunit influenza vaccine.; US licensed trivalent inactivated subunit influenza vaccine -Fluvirin (Novartis Vaccines and Diagnostics) is approved for use in subjects ≥4 years.; US licensed trivalent subunit inactivated influenza vaccine- Fluzone (Sanofi Pasteur) is approved for use in children <4 years.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: seasonal influenza, vaccine
TXV13-01 Estradiol Vaginal Softgel Capsules in Treating Postmenopausal Women With Symptoms of Vulvar and Vaginal Atrophy
Condition: Menopause; Vulvovaginal Atrophy; Painful Intercourse; Dyspareunia
MeSH terms: Dyspareunia; Atrophy
Study type: Interventional
Phase: Phase 2

Summary: 
      The study was designed to evaluate the efficacy and safety of TX-12-004-HR 10 μg in treating
      moderate to severe symptoms of vaginal atrophy associated with menopause after 14 days of
      treatment, and to estimate the effect size and variability of vulvovaginal atrophy endpoints.
      In addition, the systemic exposure to estradiol from single and multiple doses of
      TX-12-004-HR was to be investigated.
    

Detailed description: 
      This study was a randomized, double-blind, placebo-controlled trial to evaluate safety and
      efficacy of the TX-12-004-HR formulation in reducing moderate to severe symptoms of vaginal
      atrophy associated with menopause and to investigate the systemic exposure to estradiol
      following once daily intravaginal administrations of TX-12-004-HR for 14 days.

      Postmenopausal subjects who met the study entry criteria were randomized to one of two
      treatment groups (TX-12-004-HR or Placebo). During the Screening period subjects were asked
      to self-assess the symptoms of vulvar and/or vaginal atrophy, including vaginal dryness,
      vaginal and/or vulvar irritation/itching, dysuria, vaginal pain associated with sexual
      activity and vaginal bleeding associated with sexual activity. Subjects with at least one
      self-assessed moderate to severe symptom of vulvar and/or vaginal atrophy identified by the
      subject as being most bothersome to her were eligible to participate in the study.
    

Intervention name(s): Estradiol; placebo
Intervention type(s): Drug; Drug
Intervention description(s): 1 10 µg capsule inserted vaginally for 14 days.; 1 placebo capsule inserted vaginally for 14 days.
Other intervention name(s): 17β-estradiol
Intervention MeSH terms: Estradiol 17 beta-cypionate; Estradiol 3-benzoate; Estradiol; Polyestradiol phosphate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: VVA; Postmenopausal; Painful Sex
Are There Protective Effects of Antioxidants, Calcium Channel Blocker and Angiotensin Receptor Blocker Against Extracorporeal Shockwaves Lithotripsy Induced Renal Injury?
Condition: Kidney Calculi
MeSH terms: Kidney Calculi; Nephrolithiasis; Calculi
Study type: Interventional
Phase: Phase 4

Summary: 
      This study will be conducted to evaluate the protective effects and mechanisms of
      antioxidants (vitamins A, C, E and Selenium), calcium channel blocker (Verapamil) and
      angiotensin receptor blocker (Lozartan) against shock wave induced renal injuries.
    

Detailed description: 
      The protective effect will be evaluated via estimation of the changes in renal tubular enzyme
      (NGAL) and detection of albumen levels in urine. The mechanisms of protection will be
      investigated by estimation of renal perfusion and functional changes using dynamic MRI.
    

Intervention name(s): Antioxidant group; Calcium Channel Blockers; Angiotensin receptor blocker group; Placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): They will be receive vitamins A, C, E and selenium (Selenium ACE) Dosage: Two tablets before ESWL Then 2 tablets every 8 hours after ESWL for one week; They will receive Verapamil (Isoptin 80 mg) Dosage: One tablet 2 hours before ESWL Then one tablet every 12 hours after ESWL for one week; They will receive Losartan (Cozaar 50 mg) Dosage: One tablet 2 hours before ESWL Then one tablet every day after ESWL for one week; They will receive placebo
Other intervention name(s): Selenium ACE; Verapamil; Losartan
Intervention MeSH terms: Selenium; Losartan; Verapamil; Calcium Channel Blockers; Calcium; Angiotensin Receptor Antagonists; Antioxidants
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Prevention
Keywords: Extracorporeal shockwave lithotripsy (ESWL); Kidney calculi; Renal protection; Antioxidants; Calcium channel blockers; Angiotensin receptor blockers
Virtual Reality in Motor Neurone Disease
Condition: Motor Neuron Disease
MeSH terms: Motor Neuron Disease; Amyotrophic Lateral Sclerosis
Study type: Interventional

Summary: 
      Motor Neurone Disease (MND) is a chronic progressive neurological condition where people
      experience weakness of muscles leading to pain and restriction of movement as well as
      problems with swallowing, breathing and communication. The purpose of this study is to
      establish if Virtual Reality is useful for people with MND and if it helps improve their well
      being.
    

Detailed description: 
      Motor Neurone Disease (MND) is a chronic progressive neurological condition where people
      experience weakness of muscles leading to pain and restriction of movement as well as
      problems with swallowing, breathing and communication.

      As people become increasingly immobile, they become restricted in their ability to perform
      activities of daily living, access the outdoors, participate in preferred occupational roles
      or engage in leisure activities. Consequently, there is a deterioration in their ability to
      experience well being and have quality of life. There is also a significant carer burden as
      the carer spends long hours in the day looking after the person. The average disease
      trajectory lasts between 3-5 years, followed by death. More recently, the use of Virtual
      Reality (VR) technology is being recognised in the field of health. This technology uses the
      interactions between an individual and a computer generated environment to stimulate
      different sensory modalities such as visual and auditory. The technology can be accessed
      commonly using head mounted goggles or head sets. The entertaining or stimulating effect of
      VR is useful in redirecting the person's attention away from the distressing experiences,
      such as pain and anxiety. The purpose of this study is to establish if VR is useful for
      people with MND and if it helps improve their well being.
    

Intervention name(s): Virtual Reality Headset
Intervention type(s): Device
Intervention description(s): Virtual Reality Headset
Intervention model: Single Group Assignment
Intervention model description: Device Feasibility
Masking: None (Open Label)
Primary purpose: Supportive Care
Study In Healthy Subjects To Evaluate The Changes In The Protein sAPP-Alpha In Cerebrospinal Fluid Following A Single Oral Dose Of PF-04995274
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary purpose of the study is to evaluate the effect of PF-04995274 on cerebrospinal
      fluid levels of soluble Amyloid precursor protein fragments and Amyloid beta fragments
      following single oral dose in healthy volunteers. Safety and tolerability of PF-04995274
      single dose administration in healthy volunteers will also be assessed as part of the
      objectives.
    

Detailed description: 
      The purpose of the study is to evaluate the effect of PF-04995274 on CSF levels of s-APP and
      Abeta fragments following single oral dose in healthy volunteers
    

Intervention name(s): PF-04995274; PF-04995274
Intervention type(s): Drug; Drug
Intervention description(s): Subjects will be randomized to receive single oral doses of 0.1 mg, 10 mg, 15mg/ 40 mg PF-04995274 or a placebo; Doses for cohort 2 will be decided based on an Interim analysis of data from cohort 1. The highest dose to be used in Cohort 2 not to exceed 15mg
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Other
Keywords: healthy volunteers; pharmacokinetics-pharmacodynamics; cerebrospinal fluid; serial sampling
Impact of Chronic Ankle Instability on Gait Loading Strategy
Condition: Ankle Sprains
MeSH terms: Ankle Injuries
Study type: Observational

Summary: 
      compare the dynamic foot print outcomes in subjects suffering from chronic ankle sprain to
      heathy subjects
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        use G power soft were
The Effects of Radiation in Reconstructed Breasts
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Observational

Summary: 
      The primary objective of this study is to use LR imaging to evaluate the effects of adjuvant
      radiation therapy on reconstructed breasts.
    

Detailed description: 
      Immediate breast reconstruction following mastectomy has become an increasingly popular and
      accepted treatment option among breast cancer patients. This change in practice has resulted
      in a significant number of patients who undergo radiation therapy after breast
      reconstruction. Following irradiation, the reconstructed breast often experiences fibrotic
      contracture, volume loss, altered pigmentation, or some combination thereof, producing an
      asymmetric and aesthetically compromised result. The effects of radiation on reconstructed
      breasts as well as the implications that such changes have for timing of reconstructive
      surgery, post-operative management and surveillance imaging are topics of growing importance
      in plastic surgery, radiology and surgical oncology.
    

Intervention name(s): contract-enhanced MRI; Unilateral Adjuvant Radiation Therapy
Intervention type(s): Procedure; Radiation
Intervention description(s): Patients will have contrast-enhanced MRI of the breasts.; The study group will consist breasts receiving post-operative radiation, and the control group will consist of the patient's breasts on the non-radiated side. In this way, patients will act as their own control.
Observational model: Other
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        The target population will consist of patients with a diagnosis of unilateral breast cancer
        who elect to undero bilateral mastectomy with immediate free flap reconstruction. Patients
        will be treated by members of the Division of Plastic and Reconstructive Surgery and will
        receive postoperative radiation therapy to the affected breast.
      
Keywords: breast cancer; bilateral mastectomy; immediate breast reconstruction; locally advanced unilateral breast cancer; bilateral mastectomy for prophylaxis
Contingency Management of Psychostimulant Abuse in the Severely Mentally Ill
Condition: Drug Abuse; Schizophrenia; Bipolar Disorder; Major Depressive Disorder
MeSH terms: Substance-Related Disorders; Schizophrenia; Depressive Disorder; Depression; Depressive Disorder, Major; Bipolar Disorder
Study type: Interventional

Summary: 
      The purpose of this study is to determine the effectiveness of a behavioral treatment,
      contingency management, in reducing stimulant use in persons with serious mental illness.
    

Detailed description: 
      This study will evaluate the efficacy of a twelve week contingency management (CM)
      intervention for treating psycho-stimulant substance abuse when delivered in the context of a
      community mental health center (CMHC) setting for adults suffering from serious mental
      illness (SMI). The CM paradigm to be used is one which has been shown effective in several
      recent large clinical trials, using the variable magnitude of reinforcement procedure. The
      reinforcers will be vouchers or actual items useful for day to day living in this population.
      Two hundred SMI participants with co-occurring stimulant disorders will be recruited from a
      large urban CMHC and randomized to receive either the active CM paradigm plus treatment as
      usual (TAU), or TAU which will include the delivery of reinforcement for study involvement
      (reinforcement that is not contingent on drug abstinence). The primary outcome is change in
      psycho-stimulant use (methamphetamine, amphetamine and/or cocaine). Secondary outcomes
      include: changes in use of other illegal drugs or alcohol; changes in CMHC treatment
      adherence and follow-through; changes in psychiatric symptoms, quality of life, and community
      outcomes (homelessness, incarcerations, etc.). Additional outcomes to be measured include
      changes in drug craving, stage of change, nicotine use, and HIV risk status. The study
      involves two phases, the 12 week treatment phase, where CM and control treatments are
      delivered, as well as a 3 month follow up phase.
    

Intervention name(s): Contingency Management; Non Contingent Control Condition
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Opportunities to earn rewards are given three times a week for 12 weeks contingent on negative urine analyses indicating drug abstinence; Opportunities to draw for rewards are provided three times a week for 12 weeks for providing urine analysis. Opportunities to earn rewards are not based on urine analysis results.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: stimulant abuse; drug abuse; schizophrenia; bipolar disorder; major depressive disorder; contingency management; psychosocial treatment