bioihbjkbjnl/mcl2 huggingface dataset:
Internet Mindfulness Meditation Intervention
Condition: Stress
Study type: Interventional

Summary: 
      Phase 1 will follow 40 subjects and hopes to address whether or not IMMI can increase
      meditation practice as compared to another meditation program. The study will last six weeks
      for both the IMMI group (20 subjects) and the Access group (20 subjects). Access groups will
      receive learning materials and guided meditations, but the implementation will be self-paced.
      Participants in the IMMI group will receive weekly learning sessions and be required to
      practice meditation every day. IMMI group participants will also receive a weekly reminder
      call from a member of the study staff and have access to technical support in the event of
      trouble with the online program. All subjects will complete online self-report questionnaires
      that measure quality of life, self-efficacy, mood, sleep, mindfulness, and perceived stress
      at baseline and at the end of the six-week intervention. Subjects will also be given a
      questionnaire at the end of the study gauging their satisfaction with the mindfulness program
      they participated in.

      Phase 2 will follow 80 subjects and hopes to address whether or not IMMI is acceptable to
      participants and demographic information about IMMI users. The study will be the same as
      noted above, but all subjects will be entered in the IMMI program.

      Differences in recruitment rates, drop out, and patient satisfaction between the IMMI and
      Access groups will be analyzed. IMMI's ability to change meditation behavior (i.e. increasing
      time or frequency of meditation sessions), and improve quality of life will be examined as
      well.
    

Detailed description: 
      Participants will undergo the following: Week 0 - Telephone screening; Week 1 - Baseline
      Assessment; Week 2-Week 7 - Internet Mindfulness Meditation Intervention (or Access in Phase
      1); Week 8 - Endpoint Assessment
    

Intervention name(s): Internet Mindfulness Meditation; Access
Intervention type(s): Behavioral; Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Other
Keywords: mindfulness; meditation; internet
Mind-Body Skills Groups for the Treatment of War-Related Trauma in Children in Gaza
Condition: Posttraumatic Stress Disorder
MeSH terms: War-Related Injuries; Stress Disorders, Post-Traumatic
Study type: Interventional

Summary: 
      The objective of this study is to determine whether participation in a mind-body skills
      program by war-traumatized children in Gaza will result in improvement of posttraumatic
      stress symptoms, depression, and decreased hopelessness compared to a control group.
    


Intervention name(s): Mind-Body Skills Group
Intervention type(s): Behavioral
Intervention description(s): Teaching mind-body skills such as meditation, biofeedback, guided imagery, and meditation in a group setting
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Clinical Study for the Evaluation of the Safety and Initial Performance of the ClearRing System for the Treatment of Benign Prostatic Hyperplasia
Condition: Benign ProstaticHyperplasia (BPH)
MeSH terms: Prostatic Hyperplasia; Hyperplasia
Study type: Interventional

Summary: 
      The ProArc Medical ClearRing™ system is a prostatic reshaping device that is designed to
      treat Lower Urinary Tract Symptoms (LUTS) due to BPH.

      During the procedure an implant is delivered into the prostate tissue obstructing the urethra
      and restricting urine flow. The delivery system uses an electro-cutting blade to perform a
      circular and superficial incision, in which the implant is placed. Such an implant, with the
      shape of an open ring, expands the obstructed area, reducing the fluid obstruction through
      the prostatic urethra.
    

Detailed description: 
      The proposed study will be conducted on BPH patients, candidates for TURP and will aim to
      evaluate the ability of the ClearRing™ to improve BPH symptoms while conforming to safety of
      the procedure.

      In the proposed study the implants will be inserted by a dedicated delivery system with the
      aid of resectoscope. Electrical current will be administered by off-the-shelf CE Mark
      diathermy that passes through the system to cut and pave the ring course.

      The proper positioning of the implants will be evaluated by cystoscopy or TRUS and following
      implant positioning the device will be withdrawn.

      The delivery tool, the implants, resectoscope and the diathermy equipment will be supplied by
      ProArc Ltd.
    

Intervention name(s): ClearRing™
Intervention type(s): Device
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Supragingival Plaque Removal With and Without Dentifrice
Condition: Dental Plaque
MeSH terms: Dental Plaque
Study type: Interventional
Phase: Phase 2

Summary: 
      Purpose: The aim of this study was to compare the efficacy of dental biofilm removal by
      brushing with and without conventional toothpaste. Settings and Design: Twenty-four students
      aged 17 to 28 years old participated in this randomized clinical trial.

      Materials and Methods: Quadrants 1-3 or 2-4 were randomly allocated to the test group
      (brushing without dentifrice) or control group (brushing with dentifrice). After 72 hours of
      cessation of oral hygiene, Quigley & Hein (Turesky) plaque index was assessed before and
      after brushing by a calibrated and blind examiner. Overtime and intergroup comparisons were
      performed by paired sample t test.
    


Intervention name(s): Toothbrushing With Dentifrice; Toothbrushing Without Dentifrice
Intervention type(s): Other; Other
Intervention description(s): The participants were instructed to interrupt any chemical and/or mechanical oral hygiene procedure for 72 hours. Dental plaque was stained by a 2% erithrosin solution, followed by a mouth rinsing with water for 1 minute. Next, the set of dental quadrants (1-3 and 2-4) were randomly allocated to experimental groups by the flip of a coin. One of the sets was brushed with multi bristle brush without the use of dentifrice and the second set was brushed with multi bristle brush using dentifrice. Toothbrushing was performed by the individual's regular technique timed. Two minutes was used for each set. After toothbrushing, the dental biofilm was again stained and evaluated by the same examiner, who was blind to the quadrants brushed with or without dentifrice.; The participants were instructed to interrupt any chemical and/or mechanical oral hygiene procedure for 72 hours. Then, dental plaque was stained by a 2% erithrosin solution, followed by a mouth rinsing with water for 1 minute. Next, the set of dental quadrants (1-3 and 2-4) were randomly allocated to experimental groups by the flip of a coin. One of the sets was brushed with multi bristle brush without the use of dentifrice and the second set was brushed with multi bristle brush using dentifrice. Toothbrushing was performed by the individual's regular technique timed. Two minutes was used for each set. After toothbrushing, the dental biofilm was again stained and evaluated by the same examiner, who was blind to the quadrants brushed with or without dentifrice.
Other intervention name(s): Brushed with multi bristle brush; Dentifrice closeUp
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Toothbrushing; Dental plaque; Dentifrice; Oral hygiene
The Acute Effect of Spices on Vascular Health
Condition: Oxidative Stress
Study type: Interventional

Summary: 
      The investigators aim to conduct a 3-period randomized controlled crossover study to
      investigate the postprandial effects of a high fat meal with spice on endothelial function,
      lipids/lipoproteins, immune function and plasma markers of antioxidants and oxidative stress.
      Metabolomic profiling will also be conducted. In random order, participants will consume
      either a high fat meal (1000kcal, 45g fat) or a high fat meal containing 2g of spice or a
      high fat meal containing 6g of spice. Between each treatment there will be a washout period
      of at least 3 days. It is hypothesized that consumption of a high fat meal with spice will
      attenuate postprandial endothelial impairment and triglyceride levels in a dose response
      manner compared with a high fat meal.
    

Detailed description: 
      A 3-period randomized controlled crossover study will be conducted to investigate the
      postprandial effects of a high fat meal with spices on endothelial function,
      lipids/lipoproteins, immune function, plasma antioxidants and markers of oxidative stress.
      Metabolomic profiling will also be conducted. In random order participants will consume
      either a high fat meal (1000kcal, 45g fat) or a high fat meal containing 2g of spices or a
      high fat meal containing 6g of spices with a 3 day washout period between each treatment. The
      following spices will be incorporated into the meal black pepper, basil, bay leaf, cinnamon,
      coriander, cumin, ginger, oregano, parsley, rosemary, red pepper, turmeric and thyme.

      Endothelial function will be measured by flow mediated dilation of the brachial artery in the
      fasting state and 2 and 4 hours after the meal. Participants will also provide a fasting
      blood sample and samples will also be taken at 1, 2, 3 and 4 hours after the meal.
    

Intervention name(s): Herbs and spices; High fat meal
Intervention type(s): Other; Other
Intervention description(s): Mix of commonly used herbs and spices; Meal containing 1000kcal and 45g fat
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: glucose regulation; lipids; Immune markers; Endothelium, Vascular
Preimplantation Genetic Diagnosis (PGD) With Gonadotropin-releasing Hormone (GnRH) Agonist Versus Antagonist
Condition: Reproductive Endocrinology; Fertility; Optimal Stimulation Protocol
Study type: Interventional
Phase: Phase 4

Summary: 
      The aim of our study is to define the optimal ovarian stimulation protocol concerning PGD and
      for this reason we plan a randomized controlled trial (RCT) comparing gonadotropin-releasing
      hormone (GnRH) agonist protocol versus GnRH antagonist protocol. The follicle stimulating
      hormone (FSH) preparation in both arms will be highly purified FSH (Menopur®).
    

Detailed description: 
      Patients will be randomized at the outpatient clinic in two groups.
    

Intervention name(s): GnRH agonist; GnRH antagonist; hP-hMG; Human chorionic gonadotropin; Progesterone
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): induction of final oocyte maturation
Other intervention name(s): Suprefact nasal spray; Orgalutran or Cetrotide; Menopur; Pregnyl; Utrogestan vaginal tablets
Intervention MeSH terms: Chorionic Gonadotropin; Cetrorelix; Progesterone; Prolactin Release-Inhibiting Factors; Ganirelix
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: Intracytoplasmic sperm injection (ICSI); PGD; GnrH agonist; GnRH antagonist
Bioavailability of BIBR 953 ZW Under Influence of Food in Healthy Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      Study to investigate the relative bioavailability of BIBR 953 ZW after administration of a
      150 mg BIBR 1048 HPMC (hydroxypropylmethylcellulose) capsule versus BIBR 953 ZW after
      administration of a 150 mg BIBR 1048 gelatine capsule, and to investigate the relative
      bioavailability of BIBR 953 ZW given as BIBR 1048 MS HPMC capsule with food versus without
      food.
    


Intervention name(s): BIBR 1048 MS HPMC capsule; BIBR 1048 MS gelatine capsule
Intervention type(s): Drug; Drug
Intervention MeSH terms: Dabigatran
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Study of the Gut Barrier and Blood Vessel Inflammation in Individuals With and Without HIV
Condition: HIV
MeSH terms: Inflammation
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this research study is to determine whether teduglutide can repair a "leaky"
      gut, decrease inflammation, and prevent or treat plaque, a build-up of fat and other
      materials in the blood vessels of the heart, in people with HIV. HIV disease is linked to
      inflammatory changes and leakiness of the gut. These changes or conditions may increase the
      risk of developing heart and blood vessel disease. The investigators believe teduglutide can
      help repair the gut barrier in people with HIV, leading to a decrease in inflammation and
      plaque in the blood vessels of the heart.
    

Detailed description: 
      As more people with HIV gain access to combination antiretroviral therapy (cART),
      cardiovascular disease has become increasingly prevalent and a significant cause of
      mortality. Activation of the innate immune system may stimulate inflammatory mechanisms of
      atherosclerosis development. Loss of gastrointestinal (GI) mucosal epithelial integrity and
      loss of CD4+ T-lymphocytes in the intestinal lamina propria occur in HIV-infected patients
      and are not fully restored by cART. Translocation of microbial products from the intestinal
      lumen into the systemic circulation has been demonstrated to be increased in HIV-infected
      patients and the investigators hypothesize that it is a key driver of monocyte and macrophage
      activation. In turn, these pro-inflammatory monocytes and macrophages can induce
      atherosclerotic disease development. The purpose of the research study is to determine the
      effects of a glucagon-like peptide-2 analog, teduglutide, on intestinal epithelial integrity,
      microbial translocation across the gut lumen, markers of innate immune system activation
      including the monocyte transcriptome, bone, arterial inflammation, and atherosclerosis in a
      6-month randomized, double-blind placebo-controlled proof of concept trial in HIV-infected
      individuals.
    

Intervention name(s): Teduglutide; Placebo
Intervention type(s): Drug; Drug
Other intervention name(s): Gattex
Intervention MeSH terms: Teduglutide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: HIV; Atherosclerosis; Microbial Translocation; Teduglutide; Gastrointestinal Permeability; Inflammation
Evaluation of Two Type III GBS Polysaccharide-Tetanus Toxoid Conjugate Vaccines
Condition: Bacterial Infections; Group B Streptococcus
MeSH terms: Bacterial Infections; Tetanus
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to test the safety and favorable immune response to an
      anti-streptococcal vaccine (a vaccine that treats a common bacterial infection) in healthy
      non-pregnant women.

      Group B Streptococcus (GBS) continues to be the single most frequent cause of
      life-threatening bacterial infection during the first 2 months of life. Further, GBS
      pregnancy-related morbidity afflicts more than 50,000 women annually in the US. Therefore,
      active immunization of women is an appealing strategy for the prevention of GBS disease in
      pregnant women and their infants during the first 3 months of infant life.
    

Detailed description: 
      In this study 65 healthy, non-pregnant women will receive a single dose of one of two
      anti-streptococcal vaccinations. Both types of vaccinations are given in upper arm by
      injection into the muscle. To assess the vaccine effectiveness, patients have blood drawn and
      examined at weeks 4, 8 and 26, post-vaccination.
    

Intervention name(s): GBS III-TT-SSI; GBS III-TT-MPHL
Intervention type(s): Biological; Biological
Masking: Double
Primary purpose: Prevention
Keywords: Clinical Evaluation
Whole-Body Vibration for Functional Constipation
Condition: Constipation
MeSH terms: Constipation
Study type: Interventional

Summary: 
      1. Aim: The aim of this trial was to determine whether whole-body vibration (WBV) induced
           via a non-invasive oscillation platform could improve symptoms and health-related
           quality of life (HRQOL) in patients with chronic functional constipation.

        2. Methods: A single-blinded, randomized, control trial was performed in a single Hospital
           in Taiwan. Patients diagnosed with chronic functional constipation, as per the Rome III
           diagnostic criteria were included and randomized to either the WBV treatment or no
           treatment (control) group. The treatment group received six 15-minute sessions of WBV
           therapy over a two-week period. Patients received vibrations of 2 mm in amplitude at a
           frequency of 12 Hz. The primary outcome was assessed by the constipation severity
           instrument (CSI). The secondary outcome was improvements in HRQOL.
    


Intervention name(s): whole body vibration
Intervention type(s): Procedure
Intervention description(s): to deliver mechanical oscillation to individuals at various frequencies, amplitudes, and accelerations for different durations. This technique has been applied for years to enhance strength, and improve bone mineral density and balance
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Perception About Upper Limb Functional Recovery, Barriers & Use of Training Devices Among Indian Stroke Survivors.
Condition: Stroke, Middle Cerebral Artery With Infarction, Rehabilitation, Upper Limb Recovery, Economic Burdon
MeSH terms: Stroke; Infarction, Middle Cerebral Artery; Infarction
Study type: Observational [Patient Registry]

Summary: 
      The goal of this observational study is to evaluate perceptions regarding affected arm and
      hand function and their willingness to use devices to enhance upper limb functions among
      stroke survivors. The main question[s] it aims to answer are:

        -  what will the stroke survivor's perception of interventions and device development in
           his/her arm recovery?

        -  Wheather he is willing to use it for his arm recovery?
    

Detailed description: 
      Individuals with stroke will be recruited from MGM Hospital and other hospitals from
      Aurangabad. Participants will be adults (age >30) with stroke and with the capacity to
      provide written or verbal informed consent, and the ability to communicate
      verbally/online/phone. Participants will be contacted via phone or email by a member of the
      research team. If needed personal interviews of the patients will be taken. The research team
      will consist of the author and one helper Physical Therapy student and the guide. All team
      members participating in the training will ensure consistency in communications with
      participants. All the participants will be provided with information about the study
      objectives and procedures and will be asked if they are willing to participate. If they
      consent, they will be given one of three options:

        1. Complete the survey via phone immediately

        2. Complete the survey online. In this case, they will be sent a link to their email to
           complete an online survey.

        3. Complete the survey via personal interview
    

Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        Stroke Survivors
User Performance and System Accuracy Evaluations Using Glucose Adjustment
Condition: Type 1 Diabetes Mellitus
MeSH terms: Diabetes Mellitus, Type 1
Study type: Interventional

Summary: 
      This is an open-label, non-randomised pilot study, to evaluate user performance and system
      accuracy in blood Glucose monitoring system with glucose adjustment. Twelve male and female
      volunteers aged 18-45, with a documented diagnosis of Type I diabetes for at least 12 will be
      enrolled in this study.
    


Intervention name(s): Blood Glucose Monitoring Systems.
Intervention type(s): Device
Intervention description(s): In vitro diagnostic medical device.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Comparison of Real-tiMe ContInuous gLucosE moNitoriNg With Self-monitorIng of Blood Glucose in Young AduLts With Type 1 diabeteS
Condition: Diabetes Mellitus, Type 1
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional

Summary: 
      The main objective of this study is to determine whether real-time continuous glucose
      monitoring (CGM) for 8 weeks is more efficacious compared to self-monitoring of blood glucose
      (SMBG) in young adults with type 1 diabetes.
    

Detailed description: 
      This is an open-label, multi-centre, randomised, crossover design study, involving a 2-week
      run-in period with blinded CGM, followed by two 8 weeks study periods during which subjects
      will monitor daily glucose levels either with real-time CGM or SMBG in random order. Subjects
      will wear a blinded CGM for a 3-week period during the Control phase. A total of up to 40
      subjects (aiming for 30 completed subjects) aged 16 to 24 years with T1D will be recruited
      through diabetes clinics and other established methods in participating centres. Subjects who
      drop out of the study within the first 2 weeks of the first intervention period will be
      replaced.

      Subjects will receive appropriate training in the use of real-time CGM. Subjects will have
      regular contact with the study team during the study.

      The primary outcome is time spent in target range between 3.9 and 10.0 mmol/L as recorded by
      CGM. Secondary outcomes are the HbA1c, time spent with glucose levels above and below target,
      as recorded by CGM, and other CGM-based metrics. Measures of subject's responses in terms of
      daily diabetes management, diabetes distress and diabetes technology use and acceptance will
      also be evaluated in this study.
    

Intervention name(s): Real-time continuous glucose monitoring; Self-monitoring of blood glucose
Intervention type(s): Device; Device
Intervention description(s): Subjects randomised to Real-time continuous glucose monitoring will be given a Dexcom G5 or similar, training on its use, and HbA1c measurements taken at the start and end of the study. They will also be given validated questionnaires to complete.; Subjects randomised to self monitoring of blood glucose will be given a masked CGM which will be applied for one week, during Week 1, 4 and 8. HbA1c measurements will be taken at the start and end of the study. They will also be given validated questionnaires to complete.
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: This is an open-label, multi-centre, randomised, crossover design study, involving a 2-week run-in period with blinded CGM, followed by two 8 weeks study periods during which subjects will monitor daily glucose levels either with real-time CGM or SMBG in random order.
Masking: None (Open Label)
Primary purpose: Other