bioihbjkbjnl/mcl2 huggingface dataset:
HOME Study: Hysteroscopic Office Myomectomy Evaluation
Condition: Uterine Fibroids; Polyps
MeSH terms: Leiomyoma; Myofibroma; Polyps
Study type: Interventional

Summary: 
      The purpose of this study is to demonstrate safety and effectiveness of the MyoSure Tissue
      Removal System when used by community gynecologists in an office setting for the treatment of
      patients with symptomatic intrauterine polyps and submucosal fibroids.
    

Detailed description: 
      Approximately one hundred subjects will be enrolled in a randomized, comparative setting
      study conducted at 10-15 investigational sites. Sixty subjects will be randomized to undergo
      treatment in an office setting, and 40 subjects will be randomized to undergo treatment in a
      hospital or ambulatory surgical center (ASC) setting. Subjects will undergo a hysteroscopic
      tissue removal procedure to remove intrauterine polyps, type 0 fibroids, or type I fibroids.
      Saline infused sonohysterogram images (SIS) obtained at three months post treatment will be
      compared to pre-treatment images, to determine the percent reduction in target pathology
      volume. Additionally, subject self-reported pain scores (as rated on an 11 point scale) will
      compare pain occurring during the treatment procedure to the average pain level experienced
      during a PAP smear. Economic data will be collected and compared between the two treatment
      settings.
    

Intervention name(s): Myomectomy
Intervention type(s): Device
Intervention description(s): Removal of fibroids and / or polyps
Other intervention name(s): Fibroid removal; Polyp removal
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: morcellator; hysteroscope; myomectomy; polypectomy; uterine fibroids; uterine polyps; office; cost; local anesthetic; cervical block; pain management
APT001 Plasma/NO Generator to Treat Diabetic Foot Ulcer in Adults
Condition: Foot Ulcer, Diabetic
MeSH terms: Diabetic Foot; Foot Ulcer; Ulcer
Study type: Interventional

Summary: 
      This is a 10-week, randomized, controlled study to evaluate the efficacy and safety of the
      APT001 plasma and nitric oxide treatment in subjects with a diabetic foot ulcer.
    

Detailed description: 
      Approximately 80 subjects will be randomized by computer to receive equally either sham
      therapy or plasma / nitric oxide treatments topically. The nitric oxide / plasma treatment
      will be delivered from 11.5 to 15 centimeters from the wound surface for 10 seconds per cm2
      of wound size. Subjects will be evaluated for efficacy and safety on a regular basis with
      clinical observations. The wounds of both groups will be treated with sharp debridement as
      determined by the site Investigator. A collagen dressing, a non-adherent dressing, and an
      absorptive dressing will be applied to the wound after either the study therapy or the sham
      therapy.

      For an initial safety evaluation in patients with DFU, the first ten patients randomized will
      be limited to wound size of 7 cm2 or less and their wounds will be assessed 2-4 days after
      each treatment session. Following completion of the final assessment in these 10 patients,
      data will be submitted to FDA for review and approval before opening the enrolment for the
      remaining patients.
    

Intervention name(s): APT001; SHAM
Intervention type(s): Device; Device
Intervention description(s): APT001, is a portable device that uses plasma energy to deliver nitric oxide to the tissues.; Portable device that uses warmed room air to mimic delivery of the APT001 treatment.
Other intervention name(s): APT001 Plasma/Nitric Oxide
Intervention MeSH terms: Nitric Oxide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Take HEED (Healthy Eating and Exercise Decisions)
Condition: Obesity
MeSH terms: Obesity
Study type: Interventional

Summary: 
      This is a randomized intervention that examines the effect of culturally adapted weight loss
      program in African American (AA) females age 40-65. Evidence suggests that AA women are more
      successful with weight loss programs that are culturally tailored (Karanja, et al, 2002).
      Take HEED is a combination of 2 interventions, Therapeutic Lifestyle Changes Diet (TLC) from
      ATP-III and the CHANGE exercise program, which have shown success independently in previous
      clinical trials with AAs.
    

Detailed description: 
      Project/study objective(s), This is a randomized intervention that examines the effect of
      culturally adapted weight loss program in African American (AA) females age 40-65. Evidence
      suggests that AA women are more successful with weight loss programs that are culturally
      tailored (Karanja, et al, 2002). Take HEED is a combination of 2 interventions, Therapeutic
      Lifestyle Changes Diet (TLC) from ATP-III and the CHANGE exercise program, which have shown
      success independently in previous clinical trials with AAs.

      Methods, The 21 month program (6 months active intervention and 15 months maintenance) is
      provided by a Nurse matched with the study participants for race, age, and gender. Take HEED
      uses behavior change strategies (Prochaska et al 1992) which have been modified to include
      spirituality, AA cultural materials and examples woven into the lesson plans, and sustained
      peer support. The diet has been modified to include calorie reductions, increased fruit/
      vegetable and calcium intake, incorporation of AA ethnic recipes. Exercise has been
      culturally adapted featuring line- dancing, brisk walking and includes socialization time for
      development of strong interpersonal bonds that will encourage exercise in the participants.
      The control group receives KP's usual care which is a combination of nutrition classes and
      web based learning.
    

Intervention name(s): culturally adapted behavior change
Intervention type(s): Behavioral
Intervention description(s): Behavior change strategies which have been modified to include spirituality, AA cultural materials and examples woven into the lesson plans, and sustained peer support.
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: obesity; behavior change; cultural adaptations; weight loss
Clinical Efficacy of Bovine Freeze-dried Amniotic Membrane on Wound Healing in Laser Treatment
Condition: Biological Dressings
Study type: Interventional

Summary: 
      Bovine amniotic membrane may show better efficacy than hydrocolloid dressing.
    

Detailed description: 
      Bovine amniotic membrane as a biological dressing can be applicable to wound after laser
      treatments. Comparing with hydrocolloid dressing material, which is the most widely used
      after laser treatment now, amniotic membrane will show better efficacy. Thus, with amniotic
      membrane, epithelization time will shorten and redness which is usually left after laser will
      disappear quickly.
    

Intervention name(s): laser treatments; amniotic membrane application; hydrocolloid application
Intervention type(s): Procedure; Other; Device
Other intervention name(s): Laser ablation of the skin lesions; dressing with amniotic membrane; dressing with hydrocolloid as a comparator
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Laser therapy; Biological dressing; Amniotic membrane; Hydrocolloid bandages; wound healing
Study Evaluating the Efficacy and Safety of Simvastatin Alone Compared With Simvastatin Plus Ezetimibe in Type 2 Diabetic Patients (0653-021)(COMPLETED)
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to determine if the addition of ezetimibe 10 mg daily to ongoing
      20 mg simvastatin daily will reduce LDL Cholesterol to a greater extent than increasing the
      dose of simvastatin to 40 mg daily in Type 2 diabetics treated with Thiazolidinediones (TZD).
    


Intervention name(s): MK0653, ezetimibe / Duration of Treatment: 30 Weeks; Comparator : ezetimibe (+) simvastatin / Duration of Treatment: 30 Weeks
Intervention type(s): Drug; Drug
Intervention MeSH terms: Simvastatin; Ezetimibe
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Follow-up of Study AN004T to Assess the Persistence of AllerT Efficacy During the 2nd to 4th Season After Treatment
Condition: Birch Pollen Allergy
MeSH terms: Rhinitis, Allergic, Seasonal
Study type: Observational

Summary: 
      Study aiming to evaluate the efficacy of a 2-month pre-seasonal treatment with an AllerT 50
      µg or 100 µg maintenance dose administered in previous study AN004T in reducing symptoms of
      allergic rhinoconjunctivitis during the 2nd following birch pollen season.
    

Detailed description: 
      Multicenter, international, parallel-group follow-up study of subjects randomized and treated
      in Study AN004T (AllerT 100 µg, AllerT 50 µg, placebo) and followed over the 2nd, and if
      appropriate, the 3rd and 4th birch pollen seasons in this study (still double-blind during
      the 1st year, open-label in the 2nd and 3rd years).
    

Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Subjects with moderate to severe allergic rhiniconjunctivitis to birch pollen
      
Keywords: rhinoconjunctivitis; birch pollen; desensitization; allergen immunotherapy
An International Pulmonary Embolism Registry Using EKOS
Condition: Pulmonary Embolism and Thrombosis
MeSH terms: Pulmonary Embolism; Thrombosis; Embolism; Embolism and Thrombosis
Study type: Observational [Patient Registry]

Summary: 
      This registry is designed to understand acoustic pulse thrombolysis (APT) treatment regimens
      used as standard of care globally for pulmonary embolism. The registry will include
      individuals who have already received the APT treatment and those that will undergo APT
      treatment.
    

Detailed description: 
      For the prospective arm of the registry, a physician will have selected the APT procedure for
      the treatment of pulmonary embolism. The APT treatment and follow-up assessments are per
      clinical judgement and institutional standard of care which may vary at each clinical site.

      For the retrospective arm of the registry, the investigators will gather data from
      consecutive cases of individuals who received the APT treatment for pulmonary embolism.
      Specific baseline, treatment, and long-term health information is collected and
      de-identified.
    

Intervention name(s): EkoSonic Endovascular System with thrombolytic
Intervention type(s): Device
Intervention description(s): The device uses ultrasonic waves in combination with clot-dissolving thrombolytic drug to effectively dissolve clots.
Other intervention name(s): Acoustic Pulse Thrombolysis; EKOS
Intervention MeSH terms: Fibrinolytic Agents
Observational model: Cohort
Time perspective: Other
Sampling method: Non-Probability Sample
Study population: 
        Individuals with intermediate-high and high risk pulmonary embolism who are selected to
        receive treatment using the EKOS device and thrombolytic.
      
Keywords: venous thromboembolism
Observational Study of Baska Mask, a New Supraglottic Airway Device in Children
Condition: Baska Mask Efficacy and Safety in Children
Study type: Interventional
Phase: Phase 2

Summary: 
      The investigators wish to accumulate initial data on the performance and safety of the Baska
      mask in paediatric patient population.
    


Intervention name(s): Placement and use of Baska mask
Intervention type(s): Device
Intervention description(s): Use of Baska mask as a supraglottic airway during general anesthesia
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Baska Mask; Supraglottic airway device; Children; Pediatric
GIP and GLP-1 in Type 1 Diabetes
Condition: Hypoglycemia
MeSH terms: Hypoglycemia
Study type: Interventional

Summary: 
      Investigation of Glucose-dependent Insulinotropic Polypeptide (GIP) effects at hyper and
      hypoglycemia in type 1 diabetes.
    


Intervention name(s): GIP; GLP-1; Saline
Intervention type(s): Other; Other; Other
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Infliximab IBD Influenza Vaccine Study
Condition: Inflammatory Bowel Disease
MeSH terms: Influenza, Human; Intestinal Diseases; Inflammatory Bowel Diseases
Study type: Interventional

Summary: 
      The investigators will compare the immunogenicity of influenza vaccine in adults and children
      with inflammatory bowel disease by timing of vaccine in relation to maintenance infliximab
      dosing. The primary objective is to compare the proportion of IBD patients on maintenance
      infliximab who mount serologic protection to each component of the influenza vaccination
      between patients vaccinated on day of infliximab infusion (Day 0 to 4) and patients
      vaccinated at the mid-point between infliximab infusions (Day 21 to 28). Serologic protection
      will be defined by a hemagglutination-inhibition titer ≥ 1:40. The secondary objective is to
      compare the proportion of IBD patients who mount an immunogenic response (≥ 4-fold increase
      from pre to post-vaccination titer) to each component of the influenza vaccination between
      patients vaccinated on day of infliximab infusion and those vaccinated at the mid-point.
    


Intervention name(s): Influenza vaccination
Intervention type(s): Biological
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Influenza vaccine; Immune response; Remicade (infliximab); Inflammatory bowel disease
The Effects of Lactobacillus Plantarum PS128 in Self-Reported Insomniacs
Condition: Insomnia
Study type: Interventional

Summary: 
      To determine whether PS128 (1) reduces the severity of anxiety and depressive symptoms, (2)
      adjusts autonomic nervous system functioning, and (3) improves sleep quality.
    

Detailed description: 
      Forty participants with self-reported insomnia between 20 and 40 years old were randomly
      assigned to two groups, the PS128 and a placebo group, under the double-blind trial.
      Participants took two capsules with or without PS128 after dinner for 30 days. Study measures
      included subjective depressive symptoms, anxiety and sleep questionnaires, and miniature
      polysomnography (miniature-PSG) recordings at baseline and on the 15th and 30th days after
      taking capsules.
    

Intervention name(s): PS128; placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Participants took two capsules with PS128 after dinner for 30 days.; Participants took two capsules without PS128 after dinner for 30 days.
Other intervention name(s): Lactobacillus plantarum
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: PS128; Anxiety; Depression; Electroencephalography
Addressing Stigma in Screening and Diagnostic Delay for Cervical Cancer
Condition: Cervical Cancer Screening
MeSH terms: Uterine Cervical Neoplasms
Study type: Observational

Summary: 
      This study aims to 1) implement a culturally and contextually rooted innovative multifoci,
      social marketing intervention involving societal focused media campaign elements to break
      down the barriers and facilitate timely and appropriate screening practices for cervical
      cancer; 2) measure cervical cancer stigma from a culturally relevant theoretical and
      conceptual framework; and 3) assess the influence of stigma on hindering seeking the PAP
      test. Further, this is an international study that will bring together a multi-disciplinary
      investigatory team, community advocates and State health agencies to deliver a social
      marketing intervention in Southern California (the Inland Empire region specifically) and
      Trinidad and Tobago.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        200 participant recruited from the Inland Empire, Trinidad and Tobago
      
Keywords: Cervical Cancer Screening
Whether Using Sequential pH Would Improve Human Blastocyst Formation
Condition: Infertility
MeSH terms: Infertility
Study type: Interventional

Summary: 
      Any drift in extracellular pH (pHe) from the intercellular pH (pHi) could alter the mechanism
      regulating transporters and exchangers through the plasma membrane. This could lead to
      difficulty in restoring the physiological level of pHi. The critical stages that lack robust
      mechanism of regulating the pHi are the denuded oocyte, early stage of fertilization or a
      thawed embryo. This, in turn, could lead to a significant effect of the perturbations on
      embryo development. Convincing evidence regarding the optimal pHe for culturing human embryo
      is, so far, scanty and mostly anecdotal. The embryo has been reported to have a compensatory
      mechanism to grow at pHe between 7.0-7.4. Others have recommended that embryo need a
      sequential pH to viably grow suggesting that the post-genomic activation stage needs a
      slightly alkaline range of pH. However, whether this holds true remains to be examined.
    


Intervention name(s): pH Effect on blastocyst formation
Intervention type(s): Other
Intervention description(s): to investigate which pH is suitable for each stage of embryo development
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Other
Micafungin Prophylaxis During 1st Induction Chemotherapy for De Novo Acute Leukemia
Condition: Acute Leukemia
MeSH terms: Leukemia; Acute Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine whether prophylaxis with micafungin is effective in
      the induction chemotherapy for newly diagnosed acute leukemia patients.
    

Detailed description: 
      Medically fit patients with newly diagnosed acute leukemia received 50 mg micafungin
      intravenously once daily from the initiation of first induction chemotherapy to recovery of
      neutrophil count, suspected fungal infection, or unacceptable drug-related toxicity.
    

Intervention name(s): Micafungin
Intervention type(s): Drug
Other intervention name(s): mycamine
Intervention MeSH terms: Micafungin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: leukemia; induction; prophylaxis; antifungal; micafungin; phase II
Bioinformation Therapy for Gastric Cancer
Condition: Advanced Gastric Cancer
MeSH terms: Stomach Neoplasms
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The aim of this study is the synergistic effect of cancer ablation and life information
      rehabilitation therapy on unresectable gastric cancer.
    

Detailed description: 
      By enrolling patients with unresectable gastric cancer adapted to enrolled criteria,this
      study will document for the first time the synergistic effect of cancer according to local
      relief degree,progress free survival(PFS)and overall survival(OS).
    

Intervention name(s): Cancer ablation; Life information rehabilitation therapy
Intervention type(s): Device; Drug
Intervention description(s): Tumors bigger than 2 cm are fit for ablation therapy, percutaneously under CT scan or ultrasound.; Each treatment: one bottle solution each day, consecutive 3 months, oral administration
Other intervention name(s): Cryoblation or irreversible electroporation; "Qilisheng" Immunoregulatory Oral Solution
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Cancer ablation; Life information rehabilitation therapy
Comparison of Efficacy of 5% Fluorocalcium Phosphosilicate Dentifrice and Potassium Nitrate Dentifrice on Dentinal Hypersensitivity
Condition: Dentinal Hypersensitivity
MeSH terms: Hypersensitivity
Study type: Interventional
Phase: Phase 2

Summary: 
      Aim of this study was to assess and compare the efficacy of a dentifrice containing 5% fluoro
      calcium phosphosilicate and dentifrice containing potassium nitrate on Dentinal
      Hypersensitivity (DH) compared to a placebo over a period of 6 weeks.
    

Detailed description: 
      A total of 120 subjects were divided into 3 groups randomly. Group 1 was given the dentifrice
      containing 5% fluoro calcium phosphosilicate ,Group 2 was given the dentifrice containing
      potassium nitrate and group 3 was given placebo. Sensitivity scores (VAS score) were recorded
      at baseline, 2 weeks, 6 weeks.
    

Intervention name(s): 5% fluorocalcium phosphosilicate dentifrice; 5% potassium nitrate dentifrice; Placebo dentrifice
Intervention type(s): Other; Other; Other
Intervention description(s): dentifrice containing 5% fluorocalcium phosphosilicate and VAS score assessed at Baseline, 2 weeks, 6 weeks; 5% potassium nitrate dentifrice and VAS score assessed at Baseline, 2weeks, 6 weeks.; placebo dentifrice and VAS score assessed at Baseline, 2weeks, 6 weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Dentinal Hypersensitivity; Visual Analogue Score