bioihbjkbjnl/mcl2 huggingface dataset:
Non-Invasive Reduction of Abdominal Fat Utilizing the CoolFlex and eZ App 6.3 Applicators
Condition: Fat Reduction in the Abdomen
Study type: Interventional

Summary: 
      This study is being performed to reduce unwanted abdominal fat using two different
      applicators for the Zeltiq System.
    

Detailed description: 
      The primary objective of the study is to evaluate the performance of the CoolFlex applicator
      compared to the performance of the eZ App 6.3 applicator in the treatment of abdominal fat in
      terms of its ability to achieve a discernable change to the contour of the treated area.
    

Intervention name(s): The Zeltiq System
Intervention type(s): Device
Intervention description(s): Non-invasive cooling is applied to the treatment area with a defined cooling rate and duration.
Other intervention name(s): Cryolipolysis; Lipolysis
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Lipolysis; Cryolipolysis; Fat Reduction
A Randomised, Phase II, Comparative Study With a Parallel Control for Evaluating the Efficacy and Safety of Combined Treatment of Lutropin Alpha and Recombinant Human Luteinizing Hormone in the Middle of the Controlled Ovarian Stimulation Follicular Phase in Women With Reduced Ovarian Reserve
Condition: Infertility; Ovulation Induction
MeSH terms: Infertility
Study type: Interventional
Phase: Phase 2

Summary: 
      This was a prospective, randomized, Phase II, comparative study with a parallel control for
      evaluating the efficacy and safety of combined treatment of recombinant human follicle
      stimulating hormone (r-hFSH) and recombinant human luteinizing hormone (r-hLH). The combined
      treatment was administered at the middle of the follicular phase in subjects undergoing
      in-vitro fertilisation (IVF) through intracytoplasmic sperm injection (ICSI) and transfer of
      embryos (ET).
    


Intervention name(s): Recombinant human follicle stimulating hormone (r-hFSH); Recombinant human luteinizing hormone (r-hLH)
Intervention type(s): Drug; Drug
Intervention description(s): Subjects will receive subcutaneous injection of recombinant human follicular stimulating hormone (r-hFSH) 300-450 International Units (IU) administered after pituitary desensitization according to the ovarian response with gonadotrophin-releasing hormone agonist (GnRH-a; at a dose of 0.1 milligram per day [mg/day]).; Subjects will receive subcutaneous injection of recombinant human luteinizing hormone (r-hLH) 150 IU/day until the end of ovarian stimulation.
Other intervention name(s): GONAL-f; Follitrophin alpha; Luveris; Lutrophin alpha
Intervention MeSH terms: Hormones; Follicle Stimulating Hormone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Reproductive technology, Assisted; Recombinant human follicle stimulating hormone (r-hFSH); Recombinant leutinizing hormone (r-hLH); Ovulation induction; Infertility
Metacognitive Therapy for Obsessive-Compulsive Disorder
Condition: Obsessive-Compulsive Disorder (OCD)
MeSH terms: Compulsive Personality Disorder; Obsessive-Compulsive Disorder
Study type: Interventional

Summary: 
      Cognitive behavior therapy is the most effective treatment of obsessive-compulsive disorder.
      However, the majority of treated patients remain symptomatic. The metacognitive therapy by
      Wells (1997) could achieve substantial gains in first pilot studies. The purpose of this
      study is to investigate this approach with a randomized controlled trial by comparing
      metacognitive therapy with exposure and response prevention for obsessive-compulsive
      disorder.
    

Detailed description: 
      The purpose of this study is to investigate metacognitive therapy by Wells (1997) with a
      randomized controlled trial by comparing metacognitive therapy with exposure and response
      prevention for obsessive-compulsive disorder.
    

Intervention name(s): Metacognitive Therapy; Exposure and Response Prevention
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Metacognitive Therapy for OCD according to Wells (1997); Exposure and Response Prevention for OCD according to Kozak & Foa (1997)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Progesterone Effect on Individuals Diagnoses With AD and PTSD.
Condition: Alcohol Dependence; Post-Traumatic Stress Disorder (PTSD)
MeSH terms: Alcoholism; Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      This is a randomized control trial with an anticipated 36 participants diagnosed with
      post-traumatic stress disorder (PTSD) and comorbid alcohol dependence. Participants will be
      randomized to receive either progesterone (200 mg. bid) or placebo in identical looking
      capsules for three days.

      One goal of this research study is to test if progesterone is more effective than placebo in
      reducing craving after exposure to trauma cues and alcohol cues in a laboratory paradigm
      among men and women with AD and PTSD. We hypothesize that progesterone in comparison to
      placebo will significantly reduce craving for alcohol in response to trauma cues alone and in
      combination with alcohol cues in individuals with AD and PTSD.

      A second goal is to examine if there are gender differences in progesterone effects on stress
      and alcohol cue-induced craving. We hypothesize that the effects of progesterone on stress
      and craving will be stronger in women than in men. Participants will be recruited primarily
      through advertisement, but also through the clinical facilities at the VA and from other
      collaborators.
    


Intervention name(s): Progesterone; Placebo (for Progesterone)
Intervention type(s): Drug; Drug
Intervention MeSH terms: Progesterone
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Alcohol Dependence; Post-Traumatic stress disorder (PTSD); Progesterone
Safety and Effectiveness of the MiniMed™ 780G System With DS5 CGM
Condition: Type 1 Diabetes
MeSH terms: Diabetes Mellitus, Type 1
Study type: Interventional

Summary: 
      The purpose of this study is to confirm the safety and effectiveness of the MiniMed 780G
      insulin pump used in combination with the DS5 CGM in type 1 diabetes adult and pediatric
      subjects in a home setting.
    

Detailed description: 
      This study is a multi-center, single arm study in insulin-requiring adult and pediatric
      subjects with type 1 diabetes on the MiniMed 780G system using DS5 as well as Medtronic
      Extended infusion set and reservoir. The run-in period and study period will be approximately
      120 days long.
    

Intervention name(s): Insulin Pump with Continuous Glucose Monitoring
Intervention type(s): Device
Intervention description(s): MiniMed™ 780G insulin pump in combination with the DS5 CGM
Intervention MeSH terms: Insulin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
ELDA: Elderly Breast Cancer - Docetaxel in Adjuvant Treatment
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to compare disease free survival of elderly breast cancer
      patients treated with standard adjuvant chemotherapy (CMF) versus experimental adjuvant
      chemotherapy (weekly docetaxel).
    

Detailed description: 
      Adjuvant combination chemotherapy, given after breast cancer surgery, has been established as
      the standard approach to reduce the risk of breast cancer recurrence in those patients at
      intermediate or high risk for recurrence. However, since elderly patients have been
      underrepresented in past clinical trials, the optimal adjuvant therapy for elderly patients
      at risk for recurrence has not yet been defined.

      Docetaxel is one of the most active drugs for patients with metastatic breast cancer and
      several trials are evaluating its efficacy in the adjuvant setting. Administration of
      docetaxel on a weekly schedule is effective and well tolerated in women with metastatic
      breast cancer.

      In this study, patients from ages 65 to 80 will be randomized to one of two treatment
      strategies:

        -  standard adjuvant chemotherapy with CMF (cyclophosphamide, methotrexate, and
           5-fluorouracil given intravenously on days 1 and 8 of each cycle)

        -  experimental adjuvant chemotherapy with weekly docetaxel (given intravenously on days
           1,8, and 15 of each cycle)

      In both treatment strategies:

        -  4 cycles of chemotherapy will administered for patients at least 10% positive for ER or
           PgR, and 6 cycles will administered for patients expressing < 10% ER or PgR

        -  patients with any positive expression of ER or PgR will receive adjuvant hormonal
           therapy with tamoxifen (20mg/day for 5 years) after concluding chemotherapy

        -  adjuvant radiation therapy will be given to patients who are candidates at the
           conclusion of chemotherapy and within 6 months of surgery.
    

Intervention name(s): docetaxel; cyclophosphamide; methotrexate; 5-fluorouracil
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): 35 mg/m2 intravenously on days 1, 8, and 15 every 28 days; 600 mg/m2 intravenously days 1, 8 every 28 days; 40 mg/m2 intravenously days 1 and 8 every 28 days; 600 mg/m2 intravenously days 1 and 8 every 28 days
Intervention MeSH terms: Cyclophosphamide; Docetaxel; Fluorouracil; Methotrexate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: elderly; adjuvant therapy; intermediate risk; high risk
Defining the Normal Human Response to Probiotics
Condition: Healthy Response to Probiotics
Study type: Interventional

Summary: 
      The study is a mono-center, randomized, semi-blinded, placebo-controlled, cross-over,
      proof-of principle study in healthy volunteers. The study will determine the probiotic effect
      of LGG on intestinal tissue and intestinal cells
    

Detailed description: 
      The study includes 3 visits. The first visit serves to check inclusion/exclusion
      criteria/complete questionnaire/give information about the study and receive consent. At
      visit 2 and 3 the included individuals will drink a placebo blend or a drink containing
      Lactobacillus rhamnosus GG (LGG®) and they will subsequently be biopsied from the upper
      intestine during endoscopy while under nurse administered propofol sedation (NAPS). There
      will be four weeks between visit 2 and 3.

      At visit 2 and 3, biopsies will be taken from duodenum and jejunum, and luminal fluids will
      be collected, and one blood sample will be collected.

      The down stream analysis will include a combination of gene expression analysis, microbiome
      analysis and classification of the individuals based on analysis of blood samples.
    

Intervention name(s): LGG; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): LGG is dissolved in water and consumed at one occasion (either at visit 2 or 3); Placebo is dissolved in water and consumed at one occasion (either at visit 2 or 3)
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Basic Science
Early Prescription of Radiography Using the Ottawa Ankle Rules by a Nurse in the Management of Isolated Ankle Trauma
Condition: Ankle Injuries; Nurse's Role; Emergencies
MeSH terms: Emergencies; Ankle Injuries
Study type: Interventional

Summary: 
      The study will be conducted in 2 phases (A and B) using two different groups of patients in
      order to prove that an early prescription of radiography using the Ottawa Ankle Rules by a
      nurse practitioner could shorten length of stay of a patient suffering from ankle trauma at
      the Hospital Center of Saint-Brieuc.
    

Detailed description: 
      Ankle sprain is an injury very frequently encountered during consultation in hospitals
      emergency departments. Its mechanism may at times leads to fracture. The Ottawa Ankle Rules
      (OAR) provide guidelines to clinicians concerning the need to perform radiographic test to
      verify whether patients with ankle injuries are suffering from fracture. If all clinical and
      anamnestic criteria are negative in accordance with the OAR, the probability of a fracture
      being present is about 0% (IC 95%). OAR are validated for adults.

      Actually, a meta-analysis has suggested that it may be beneficial to introduce a
      nurse-initiated radiographic test protocol as a standard practice in emergency departments.
      However this early prescription is not a standard of care in most of emergency departments in
      France.

      The implementation of OAR decreases irradiation levels of patients and reduces medical
      expenses. In addition, it allows to reduce patient's duration of stay in already encumbered
      emergency departments, thus reducing also overcrowding, which is known to be a major factor
      of non quality of care in such departments.

      The study will be conducted in 2 phases of 4 weeks each :

        -  The first one (Phase A) will occur in the emergency department with the application of
           OAR only by the physicians (without changing the standard of care)

        -  The second one (Phase B) will occur after the Phase A, and nurses will apply OAR before
           physicians, according to the protocol.
    

Intervention name(s): OAR application by a nurse
Intervention type(s): Other
Intervention description(s): As per protocol, in the Phase B, nurses will be allowed to apply OAR which can lead to an early radiography prescription.
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: overcrowding; x rays; emergency department; Ottawa Ankle Rules; nurse practitioner
Effect of Closed Loop Glucose Control on Exercise-Associated Hypoglycemia
Condition: Type 1 Diabetes Mellitus
MeSH terms: Diabetes Mellitus, Type 1; Hypoglycemia
Study type: Interventional

Summary: 
      The purpose of the study is to compare the glycemic control during and following aerobic
      exercise using either an open or closed-loop insulin delivery system.
    

Detailed description: 
      This is an open-label, single-center, randomized crossover study evaluating the performance
      of a closed-loop insulin delivery system using a subcutaneous glucose sensor and an external
      insulin pump and comparing it to an open-loop delivery system during aerobic exercise.
      Subject participation will be for a maximum of 16 weeks including an outpatient study (up to
      6 days) and two inpatient studies (one closed-loop; the other open-loop). The closed- and
      open-loop visit consists of approximately 67 hours over 4 days and 3 nights.
    

Intervention name(s): Closed Loop
Intervention type(s): Device
Intervention description(s): Insulin pump controlled by closed loop unit and algorithm
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
The Effect of High-intensity Laser Therapy in Patients With Carpal Tunnel Syndrome.
Condition: Carpal Tunnel Syndrome
MeSH terms: Carpal Tunnel Syndrome; Syndrome
Study type: Interventional

Summary: 
      The aim of this study is to evaluate the effects of high intensity laser therapy (HILT) on
      pain, functional status, hand grip strength and median nerve cross-sectional area in
      ultrasonography in patients with carpal tunnel syndrome.
    

Detailed description: 
      Patients who are admitted and diagnosed with carpal tunnel syndrome based on anamnesis,
      physical examination and electromyography are included in the study.
    

Intervention name(s): high-intensity laser therapy; sham high-intensity laser therapy
Intervention type(s): Device; Device
Intervention description(s): HILT: A hot laser derived from a Nd: YAG laser has 12 W (watt) and 1064 nm characteristics. The device will administered to the hand wrist area in two steps in the HILT group: phase I and phase II. The application will made utilizing continuous circular movements in both phases I and II. The first five sessions consisted of a 100-second intermittent phase analgesic effect at 8 W and 8 J/cm2 for a total energy of 200 J. The following five sessions consisted of a continuous 11 minutes 6 second bio stimulating effect with a dosage of 3 W 80 J/cm2. Over the course of two weeks, ten treatment sessions of HILT will be given.; HILT is administered as a placebo for two weeks, 5 sessions a week, for a total of 10 sessions.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: pain; High-intensity laser therapy; ultrasonography
Effect of the Natural Sweeteners Erythritol and Xylitol on Gut Microbiota and Glucose Metabolism in Obese Volunteers
Condition: Obesity
Study type: Interventional

Summary: 
      Sugar alcohols such as xylitol and erythritol are increasingly popular as sugar substitutes
      in the food industry and are also recommended to diabetic patients. Both substances are
      already in use in the food industry and are freely available. Since the 1970s, beneficial
      effects on oral health could be demonstrated as oral bacteria were influenced positively.
      Animal studies showed an increase in gut Clostridium perfringens after xylitol intake;
      certainly a non-desirable effect. However, studies on effects of erythritol and xylitol on
      the human gut microbiota are lacking so far. In this trial, investigators aim to examine
      whether gut microbiota and glucose tolerance can be influenced by polyol intake in a
      non-diabetic but obese cohort.
    


Intervention name(s): E967-Xylitol; E968-Erythritol
Intervention type(s): Dietary Supplement; Dietary Supplement
Other intervention name(s): Xylitol; Erythritol
Intervention MeSH terms: Erythritol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
To Evaluate Safety, Pharmacokinetics and Pharmacodynamics of MEDI6012 in Subjects With Stable Coronary Artery Disease
Condition: Coronary Artery Disease
MeSH terms: Coronary Artery Disease; Myocardial Ischemia; Coronary Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a Phase 2a randomized, double-blind (subject/investigator blinded, MedImmune
      unblinded), placebo-controlled, dose-escalation study to evaluate the safety, PK/PD, and
      immunogenicity of single IV and SC MEDI6012 doses in adult subjects with stable CAD.
    


Intervention name(s): MEDI6012; Placebo SC; Placebo IV
Intervention type(s): Biological; Biological; Biological
Intervention description(s): Participants received a single IV (24, 80, 240, and 800 mg) and SC (80 and 600 mg) MEDI6012 doses on Day 1.; Participants received a single SC dose of placebo matched to MEDI6012 on Day 1 of the study.; Participants received a single IV dose of placebo matched to MEDI6012 on Day 1 of the study.
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Coronary Artery Disease; CAD
The Effect of Lactobacillus Reuteri ATCC PTA 6475 on Volumetric Bone Mineral Density in Patients With Osteopenia
Condition: Osteopenia
MeSH terms: Bone Diseases, Metabolic
Study type: Interventional

Summary: 
      Lactobacillus reuteri (L. reuteri) has been widely studied in clinical trials and has
      probiotic, health-promoting effects in both adults and children, and is safe for human
      consumption. Animal models indicate that treatment with L. reuteri has positive effects on
      bone metabolism and bone density. In other animal models of diabetes and the metabolic
      syndrome, positive effects on blood glucose and weight have been reported. The present
      double-blind, placebo-controlled, randomized study is designed to investigate if dietary
      supplementation with L. reuteri twice daily for 12 months has any effect on bone density,
      body composition, inflammation, or metabolic and endocrine markers in elderly women with
      osteopenia.
    

Detailed description: 
      The role of the gut microbes for human health has gained considerable interest in recent
      years. Lactobacillus reuteri (L.reuteri) is a naturally occurring bacterial species in the
      human gut. L. reuteri has been widely studied in clinical trials of adults and children and
      treatment with L. reuteri is safe and is associated with health-promoting effects in humans.
      In animal models, L. reuteri has anti-inflammatory effects and in ovariectomized mice
      supplementation with L. reuteri partly prevented the bone loss induced by estrogen
      deficiency. Furthermore, both bone density and bone formation increased in male mice in
      another mice model. In mice with medically induced diabetes mellitus, L. reuteri reduced
      blood glucose and in a mouse model mimicking the metabolic syndrome, L. reuteri prevented
      diet-induced obesity. The present study is a double-blind, placebo-controlled, randomized,
      study in 90 elderly women with osteopenia recruited from the population. These women will be
      treated with L. reuteri or placebo orally twice daily for 12 months. The effects on bone will
      be investigated with dual energy x-ray absorptiometry, high-resolution peripheral
      quantitative computed tomography, and bone turnover markers. Hormones and markers of
      inflammation and metabolism will be followed as well as changes in the gut microbiota
      composition.
    

Intervention name(s): L. reuteri; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Dietary supplementation with L. reuteri twice daily for 12 months; Dietary supplementation with placebo twice daily for 12 months
Other intervention name(s): Lactobacillus reuteri ATCC PTA 6475
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Osteopenia; Lactobacillus reuteri; Volumetric bone mineral density