bioihbjkbjnl/mcl2 huggingface dataset:
Safety and Efficacy Study of Intrasphincteric Autologous Myoblast Injection to Treat Stress Urinary Incontinence
Condition: Stress Urinary Incontinence
MeSH terms: Urinary Incontinence; Enuresis; Urinary Incontinence, Stress
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of this pilot clinical study is to determine if intrasphincteric autologous
      myoblast injections in combination with electrical stimulation are safe and effective in
      treating stress urinary incontinence, confirming the optimal dose and assessing tolerability
      of the procedure.
    


Intervention name(s): Transurethral intrasphincteric autologous myoblast implantation
Intervention type(s): Biological
Intervention description(s): Patients undergo upper arm muscle biopsy to isolate and cultivate autologous myoblasts. Using the ultrasound-directed transurethral medical device, 15-18 aliquots (50 - 100 µl per depot) of the 2 ml myoblasts/media suspension are directly injected into the urethral rhabdosphincter at two different levels. The procedure is a single-dose injection of a cell count in range of 1x106 -5x107 cells, depending of the size/quality of the biopsy and quality of outgrowing cells in order to identify possible dose related effects. To possibly enhance cell integration following implantation, a course of transvaginal electrical stimulation is undertaken.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Urinary incontinence; Myoblasts; Muscle derived cells; Stem cells
Clinical Decision Support for Patient Migraine Management
Condition: Migraine
MeSH terms: Migraine Disorders
Study type: Interventional

Summary: 
      Little is known about who adheres to migraine management strategies, and circumstances that
      enhance adherence. This knowledge is required to develop patient-level interventions to
      improve adherence to migraine management strategies. The proposed project will pilot the
      first patient level intervention designed to improve adherence to preventive and acute
      migraine management strategies. The study will identify people most at risk for non-adherence
      to migraine management strategies. Participants will be randomly assigned to receive a
      tailored clinical decision support tool or education intervention.
    

Detailed description: 
      Participants with a diagnosis with migraine who currently meet criteria for episodic migraine
      (migraine with headaches that occur on fewer than 15 days per month) will be recruited from
      local providers. After an initial screening, eligible participants will complete 30 days of
      monitoring 3 times daily on an electronic headache diary (a smartphone app) to confirm study
      eligibility. Participants whose eligibility is confirmed will complete an additional 2 months
      (60 days) of monitoring headache activity and adherence to acute and preventive (medication
      and behavioral) strategies recommended for people with migraine. Participants who show
      suboptimal adherence during the first 3 months of monitoring (<50% of eligible days) will be
      eligible to continue to the intervention component of the study. Participants who choose to
      continue in the study will be randomized to receive a tailored clinical decision support tool
      or education intervention, both delivered through the smartphone app. Participants will
      continue to self-monitor, with the intervention components active, for 3 months.
    

Intervention name(s): Clinical Decision Support Tool; Headache Education
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Tailored education provided via a smartphone application.; Non-tailored education provided via a smartphone application.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Curative Efficacy of Secondary Prevention for Patients With Ischemic Stroke Through Syndrome Differentiation of TCM
Condition: Ischemic Stroke
MeSH terms: Stroke; Ischemic Stroke; Cerebral Infarction; Ischemia
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to assess the efficacy and safety of Naoxintong Capsule in the
      secondary prevention of ischemic stroke by the multi-center,
      randomized,double-blind，placebo-controlled trial design project.
    

Detailed description: 
      The research employs a random, double-blind, multicenter, placebo parallel and controlled
      design to observe the clinical effect of Naoxintong capsule in the treatment in ischemic
      stroke of the blood stasis syndrome on the secondary prevention，which is funded by Science
      and Technology Commission of Shanghai Municipality.The therapeutic drug of the research is
      Naoxintong capsule on the market for treatment and prevention of stroke, applicable to stroke
      patients caused by qi deficiency, blood stasis and venation stasis.The research will be
      carried out in 24 hospitals.It is a total number of 2200 volunteers，who will meet the
      inclusion criteria other than the exclusion criteria and agree to participate in the
      research.Volunteers will be randomly assigned to the experimental group or the control group.
      The trial drug for the experimental group is Naoxintong capsule, while that for the control
      group is a kind of placebo capsule.Volunteers will be regularly followed up during the
      experimental period of 2 years. It will be to evaluate the clinical efficacy of Naoxintong
      capsule on the secondary prevention by the stroke recurrence and mortality.
    

Intervention name(s): Naoxintong Capsule; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): This is Naoxintong capsule,which is composed of Huangqi,Chishao,Danshen,Danggui, Chuanxiong,Taoren,Honghua,Ruxiang,Moyao,Jixueteng,Niuxi,Guizhi,Sangzhi,Dilong,Quanxie,etal.; placebo capsule has the same as Naoxintong capsule in the appearance, shape,colour and content tinct.
Other intervention name(s): Chinese Herbal Compound; Placebo of Chinese Herbal Compound
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: ischemic stroke；Naoxintong Capsule
Study to Determine Skin Irritation and/or Sensitization Potential of an Antifungal Cream Containing Trolamine (Repeated Insult Patch Test)
Condition: Hypersensitivity
MeSH terms: Hypersensitivity
Study type: Interventional
Phase: Phase 3

Summary: 
      In this study researcher want to learn more about possible skin reactions such after repeated
      application of an antifungal cream containing Trolamine. They are especially interested in
      skin irritations or allergic skin reactions. The study plans to enroll about 225 female or
      male participants with the age 18 - 79 years. The antifungal test cream will be applied on
      the back between the shoulder blades of the participants and covered by a special dressing
      patch. This will be repeated 3 times a week for the first 3 weeks of this study applying the
      cream on the same area of the back. At each visit the skin will be investigated for redness,
      dryness and other reactions. After a rest period of two weeks the test cream will be applied
      on the same skin area as before and on a second new skin area nearby. After 2 and 4 days the
      two skin areas will again be investigated for redness, dryness and other reactions.
    


Intervention name(s): Butenafine HCl 1% (BAY1896425)
Intervention type(s): Drug
Intervention description(s): Approximately 0.2 g of cream containing butenafine HCl 1% were applied to the upper back skin.
Other intervention name(s): Antifungal Cream V61-044 containing Trolamine
Intervention MeSH terms: Butenafine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Synergistic Effect of Vedolizumab and Pentoxifylline
Condition: Crohn Disease
MeSH terms: Crohn Disease
Study type: Interventional
Phase: Early Phase 1

Summary: 
      The purpose of this study is to determine the synergistic effect and clinical benefits of
      vedolizumab and pentoxifylline in the management of patients with inflammatory bowel disease.
    


Intervention name(s): vedolizumab; Pentoxifylline; placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): standard of care; added to vedolizumab; added to vedolizumab
Other intervention name(s): Entyvio; Trental
Intervention MeSH terms: Pentoxifylline; Vedolizumab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Single-rescuer Pediatric Resuscitation
Condition: Chest Compression
Study type: Interventional

Summary: 
      The objective of this pilot study was to compare the manual chest compressions (CC) versus CC
      feedback device TrueCPR vs mechanical CC device LifeLine ARM during simulated pediatric
      cardiopulmonary resuscitation
    


Intervention name(s): Manually chest compressions; Cardiopump; LifeLine ARM
Intervention type(s): Other; Device; Device
Intervention description(s): Chest compressions performed manually without any device; Chest compressions performed with Cardiopump; Chest compressions performed using mechanical chest compressions system LifeLine ARM
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Photobiomodulation in Autism Spectrum Disorder (ASD)
Condition: Autism; Autism Spectrum Disorder
MeSH terms: Autistic Disorder; Autism Spectrum Disorder; Child Development Disorders, Pervasive
Study type: Interventional

Summary: 
      The purpose of this 8-week open-label study is to assess the tolerability, safety, and
      efficacy of Transcranial LED Therapy in patients with Autism Spectrum Disorder (ASD). The
      investigators propose to enroll up to 30 subjects of both genders ages 9-59 years with intact
      intellectual functions who meet the Diagnostic and Statistical Manual of Mental Disorders,
      Fifth Edition (DSM-5) criteria for Autism Spectrum Disorder (ASD).
    


Intervention name(s): Transcranial LED Therapy (Participants ages 9-17); Transcranial LED Therapy (Participants ages 18-59)
Intervention type(s): Device; Device
Intervention description(s): Transcranial Laser Emitting Diode (LED) Therapy (TLT) is a noninvasive intervention in which near-infrared light (830nm-850nm) is applied to forebrain.; Transcranial Laser Emitting Diode (LED) Therapy (TLT) is a noninvasive intervention in which near-infrared light (830nm-850nm) is applied to forebrain.
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: photobiomodulation
Chronic Pain After Amputation
Condition: Amputation, Traumatic; Pain; Postoperative Pain
MeSH terms: Chronic Pain; Amputation, Traumatic
Study type: Interventional
Phase: Phase 4

Summary: 
      This trial will test the effectiveness of amitriptyline in relieving chronic pain of adults
      that have had an amputation
    

Detailed description: 
      This double-masked placebo controlled trial will randomize patients (n=125) who are 6 months
      or more after amputation and have a 3 or more month history of pain to a daily dose of
      amitriptyline or a placebo for 6 weeks. Patients will receive a complete functional
      neurological examination by one of the study physicians or nurses masked to their treatment
      assignment. Study participants will also be interviewed by telephone to assess pain, pain
      interference with activities, physical and mental health, and number of health care visits
      for pain, at the beginning and end of the six-week trial and four months later.
    

Intervention name(s): Amitriptyline
Intervention type(s): Drug
Intervention MeSH terms: Amitriptyline
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Amputation; Chronic Pain; Amitriptyline
Study Comparing Bioequivalence of Two New Formulations of Premarin/MPA With Premarin/MPA Reference Formulation.
Condition: Postmenopausal Osteoporosis; Postmenopause
MeSH terms: Osteoporosis; Osteoporosis, Postmenopausal
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will compare the bioequivalence of two new investigational combination
      formulations of Premarin and medroxyprogesterone acetate (MPA) with a currently marketed
      formulation of Premarin and medroxyprogesterone, Prempro™.

      Prempro is indicated for use after menopause in women with a uterus to reduce moderate to
      severe hot flashes; to treat moderate to severe dryness, itching, and burning, in and around
      the vagina; and to help reduce your chances of getting osteoporosis (thin weak bones). The
      purpose of this study is to determine if these new formulations of Premarin and MPA provide
      the same levels of estrogen and MPA in the blood as Prempro in healthy postmenopausal women.
    


Intervention name(s): Formulations A and B of Premarin/MPA 0.45 mg/0.5 mg and PREMPRO0.45 mg/0.5 mg
Intervention type(s): Drug
Intervention MeSH terms: Estrogens, Conjugated (USP)
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: vaginal atrophy; postmenopausal osteoporosis; menopause; hot flashes
Determination of the Characteristics of Isometric Gastric Motility Measurement in Healthy Volunteers
Condition: Gastroparesis
MeSH terms: Gastroparesis
Study type: Interventional

Summary: 
      There is a clear need for a novel method that can readily assess gastric motility in daily
      clinical practice. Isometric determination of the stomach motility would avoid the use of a
      large flaccid balloon while still being affordable. The aim of this study was to determine
      the optimal balloon characteristics that enable to measure motility-induced pressure changes
      in healthy volunteers.
    


Intervention name(s): Balloon characteristics
Intervention type(s): Device
Intervention description(s): Different size balloon
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: stomach; motility
Brisk Walk on Chronic Obstructive Pulmonary Disease
Condition: COPD
Study type: Interventional

Summary: 
      To determine the effects of 30 min brisk walk on Pulmonary Functions on COPD patients To
      determine the effects of 30 min brisk walk on Health related Health-related quality of life
      (HRLQ) on Chronic obstructive pulmonary disease (COPD) patients
    


Intervention name(s): Brisk Walking Group; Conventional Breathing Exercise Group
Intervention type(s): Other; Other
Intervention description(s): Brisk Walk: 20 min/day (The researchers found, for most people, brisk walking could be defined as moving at a pace of 2.7 miles per hour or 100 steps per minute for adults under about age 60 or guidelines define brisk walking as occurring when individuals move at a pace that increases their heart rate to about 70% of their heart rate maximum) Patient will also perform breathing exercises as given to Control group, Positioning (lean forward when needed) Percussion coughing when needed; Breathing exercises: 20 min/day
Breathing Ex includes:
• Pursed lip breathing: Sit with your back straight, inhale through your nose for 2 seconds. Purse your lips like you rae blowing on hot food and then breath out slowly, take twice as long to exhale as you took to breath in 4-5 times a day
• Diaphragmatic breathing: Lie on your back on a flat surface, knees bent and head supported. Use pillow under knees to support your legs . breathe in slowly through your nose tighten your stomach, letting them fall inward as you exhale through your pursed lips. Practice these exercises 5-10 minutes about 3-4 times a day.
Positioning (lean forward when needed) Percussion coughing when needed
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Aerobic Exercise; Brisk Walk; Health-related quality of life
The Characteristics and Risk Factors of Breast Cancer Patients Trend Distinctive Regional Differences: a Cross-sectional Study
Condition: Breast Cancer; Breast Neoplasms; Breast Cancer Invasive; Breast Cancer Stage; Breast Cancer Metastatic
MeSH terms: Breast Neoplasms
Study type: Observational

Summary: 
      This cross-sectional study, conducted at the Sindh Institute of Urology and Transplantation
      (SIUT), involved a retrospective data review of all the patients diagnosed with breast cancer
      from March 2017 to December 2021. The demographic characteristics, clinical presentation,
      stage of the disease, and histopathological characteristics were analyzed.
    


Observational model: Other
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        All breast cancer patients registered at the Breast Clinic, at the Sindh Institute of
        Urology and Transplantation (SIUT), Karachi from March 2017 till December 2021 were
        included
      
Keywords: Breast cancer; Clinical audit; Breast cancer risk factors; Breast cancer screening; Clinicopathological characterisitics
Acupuncture for Postoperative Analgesia in Laparoscopic Surgery
Condition: Surgery
Study type: Interventional

Summary: 
      Auricular (ear) acupuncture treatment involves placing filiform needles in the ears at
      particular locations called acupoints. Although the mechanism for acupuncture analgesia is
      still unclear, it is believed ear acupoints work like reflex points that once stimulated with
      penetration by a needle have the ability to relieve pain in a different part of the body.

      The purpose of this study is to explore the safety and effects of auricular acupuncture
      therapy on postoperative analgesic consumption and pain scores immediately following
      laparoscopic surgery.
    

Detailed description: 
      Auricular acupuncture is a diagnostic and treatment system associated with a somatotopic
      representation of the homunculus in the ear. This acupuncture technique is similar, in
      theory, to reflexology where stimulation of a reflex point in the ear is presumed to relieve
      symptoms in another part of the body. It is hypothesized that this technique works to
      decrease pain through the reticular formation, the sympathetic and the parasympathetic
      nervous systems.

      The increasing use of laparoscopic surgery has significantly diminished the dosing and
      duration of postoperative opioid consumption compared with open surgery. However, adverse
      events related with opioid use (nausea & vomiting, pruritus, urinary retention, sedation) may
      cause delays in hospital discharge and can be especially problematic for certain sub-sets of
      high risk patients such as those with obstructive sleep apnea or prior histories of
      addiction. Investigators hypothesize that auricular acupuncture using the Battlefield
      Acupuncture Protocol will decrease opioid consumption and postoperative pain after
      laparoscopic surgery with minimal or no adverse events.

      The primary aim of this study is to assess the effects of the BFA protocol on postoperative
      analgesic consumption and the secondary aims are to assess pain scores and time to discharge
      from Post Anesthesia Care Unit following laparoscopic surgery.
    

Intervention name(s): Auricular Acupuncture; Sham Acupuncture
Intervention type(s): Other; Other
Intervention description(s): Participants will receive bilateral auricular acupuncture using the Battlefield Acupuncture (BFA) protocol while in the Post Analgesia Care Unit (PACU) following laparoscopic surgery. Acupuncture needles will be left in place for 30 minutes.; Participants will receive sham acupuncture while in the Post Analgesia Care Unit (PACU) following laparoscopic surgery. During the sham procedure, needles will be inserted bilaterally in five nonspecific ear acupoints. Acupuncture needles will be left in place for 30 minutes.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Supportive Care
Open Label, 4 Week Study of ITCA 650 in Adults With Type 2 Diabetes
Condition: Type 2 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      evaluate the safety and tolerability of ITCA 650 in subjects with type 2 diabetes mellitus.
    


Intervention name(s): ITCA 650 (exenatide in DUROS)
Intervention type(s): Drug
Intervention MeSH terms: Exenatide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Neuroendocrine and Immune Response to Stress in Schizophrenia
Condition: Schizophrenia; Schizoaffective Disorder
MeSH terms: Schizophrenia; Psychotic Disorders
Study type: Interventional

Summary: 
      This is a pilot study. We are testing the physiologic, immune and chemical responses to
      stress. We believe the results of all measures to stress will be blunted in schizophrenia
      compared to healthy controls. We will test sex, early life stress and other factors on the
      relationship to a stress response.
    

Detailed description: 
      The proposed study examines the response of neuroimmune and inflammatory responses to a
      stress in both men and women with a DSM-IV diagnosis of schizophrenia or schizoaffective
      disorder. The measurements include stress hormones or other elements in the blood which
      indicate stress . Early childhood trauma/stress (ELS) information will be collected so we can
      examine differences in those with trauma histories vs. those with none by sex. There will be
      one visit for screening before the testing visit. The sample will consist of up to 45
      clinically stable inpatients and outpatients with DSM-IV schizophrenia or schizoaffective
      disorder, of which approximately 15 will be women. We will also enroll up to 45 healthy
      controls without a DSM-IV Axis I or II disorder. Prior to the study all subjects must meet
      inclusion and exclusion criteria including a medical history.

      The (TSST) is a standard and widely used research assessment procedure that is used to
      reliably induce stress in human research participants. The TSST uses situations where people
      think they are being socially evaluated during an interview for a job. Participants are told
      they are competing with other people for this job, and their task is to convince interviewers
      that they are the best person for the job. Participants are told they have to prepare a
      speech, and complete a math challenge in their head.
    

Intervention name(s): Trier Social Stress Test
Intervention type(s): Behavioral
Intervention description(s): Participants will participate in a standardized role play (Trier Social Stress Test ). A role play is pretending to be in a certain situation. A research staff member will describe the role play, during which teh participant will act out a scene. Participants will be asked to imagine that they are in a certain role with several other research team members who will also participate in the role play. Participants will also be asked to do some math problems without using paper or pencil.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other