bioihbjkbjnl/mcl2 huggingface dataset:
Influence of Spices on Mixed Vegetable Intake Including Brassica Vegetables
Condition: Overcoming Resistance to Eating Cruciferous Vegetables
Study type: Interventional

Summary: 
      This study is being done to determine that carefully designed spice mixtures can override any
      taste aversion to brassica vegetables, increase consumption of vegetable dishes which include
      brassica vegetables.
    

Detailed description: 
      This study is to determine the liking of vegetables, intentions to consume vegetables and
      differences in responses in consumption of three individual vegetables including: broccoli
      florets, cauliflower florets, baby spinach with and without spices added by measuring: (1)
      the actual intake of blanched dishes of vegetables using a modified Universal Eating Monitor
      when dishes are eaten plain or with added spices in random order; and (2) level of eating by
      baseline eating restraint using the Three Factor Eating Questionnaire (TFEQ).

      This study will be conducted in healthy overweight subjects (30-60 years, Body Mass Index >25
      and <30). A total of 20 subjects will be recruited (10 men and 10 women). Subjects will be
      further stratified by whether their level of restrained eating (10 high and 10 low restraint
      in each group). All participants will complete a general recruitment questionnaire which
      incorporates the TFEQ (Stunkard & Messick, 1985, Cappelleri 2009) along with measures of food
      and drink preferences and allergies. To ensure large differences in restraint between groups,
      subjects will be pre-selected depending on their score on the TFEQ cognitive restraint scale,
      with scores greater than two defined as high restraint (HR), and two or less than two as low
      restraint (LR). An equal number of high restraint and low restraint eaters will be tested.

      Three different vegetables with or without spices given a total of 6 dishes will be tested in
      6 visits per subject. The order in which each participant will be presented with the spiced
      or plain vegetables is randomized. Participants will be presented with a tray containing one
      of the three different vegetables served as a buffet in containers. As each subject ingests
      the dish with or without spices the rate of eating and amount eaten will be measured using a
      computer-based system modified from the Universal Eating Monitor.

      Broccoli will be seasoned with pre-prepared spice mix containing garlic powder (0.7g), onion
      powder (0.7g), black pepper (0.25g) and basil leaves (0.12g); cauliflower (300g) with garlic
      (0.1g), dill weed (0.12g), onion (0.05g) and black pepper (0.05g); and spinach (300g) with
      dried chervil (0.07g), dried chives (0.13g), garlic (0.4g) and onion (0.4g).
    

Intervention name(s): Food consumption
Intervention type(s): Other
Intervention description(s): Cooked vegetables with spices or without spices
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Other
Keywords: spices and vegetables
Comparison Between Excisional Hemorrhoidectomy and Haemorrhoidal Dearterialisation With Anopexy
Condition: Third Degree Hemorrhoids
MeSH terms: Hemorrhoids
Study type: Interventional
Phase: Phase 4

Summary: 
      Aim of the study is to compare short term results of 2 surgical treatment for grade 3
      hemorrhoidal disease, namely: pain and postoperative morbidity,complications and
      effectiveness within 30 days, re-starting daily and working activity, patients' satisfaction
    

Detailed description: 
      Excisional haemorrhoidectomy is burdened by severe postoperative pain. For this reason less
      painful treatments have been developed, such as Doppler-guided haemorrhoidal artery ligation
      and stapled anopexy. Both techniques seem to be safe, causing little postoperative pain. A
      combination of the two techniques could possibly treat both bleeding and prolapse with
      minimal discomfort
    

Intervention name(s): Hemorrhoidectomy; Hemorrhoidal dearterialization
Intervention type(s): Procedure; Procedure
Intervention description(s): Each of the main haemorrhoid is dissected and the apex is ligated and then cut, near to the dentate line; A special instrument (THD, G.F., Medical Division, Correggio, Italy )with an incorporated Doppler probe is used to detected the six terminal branches of the superior rectal artery which are ligated above the dentate line, then a running suture is performed in order to obtain a mucopexy
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Hemorrhoidectomy, haemorrhoidal dearterialisation, anopexy
Proclear 1-D Multifocal Nondispensing Study
Condition: Presbyopia
MeSH terms: Presbyopia
Study type: Interventional

Summary: 
      This study is designed to compare the relative performance related to subjective and
      objective vision between two multifocal soft contact lenses.
    

Detailed description: 
      The aim of this study was to compare the subjective and objective vision. of Proclear® 1-D
      Multifocal test lenses (MF) with +0.75D overcorrection of the distance lens power in the
      nondominant eye compared to the Air Optix® Aqua Multifocal (CIBA VISION) contact lenses in
      low, Medium and High Add presbyopic subjects (+1.25 to +2.50 inclusive).
    

Intervention name(s): omafilcon A / PC 1-D MF; lotrafilcon B / Air Optix MF
Intervention type(s): Device; Device
Intervention description(s): Subjects were randomly assigned into either the omafilcon A/PC 1-D MF lenses with +0.75D over-correction in the non-dominant eye or the lotrafilcon B/Air Optix MF lenses then crossed-over into the alternative pair of study lenses.; Subjects were randomly assigned into either the omafilcon A/PC 1-D MF lenses with +0.75D over-correction in the non-dominant eye or the lotrafilcon B/Air Optix MF lenses then crossed-over into the alternative pair of study lenses
Other intervention name(s): Proclear Multifocal daily wear soft contact lenses; Air OPtix Aqua Multifocal extended wear soft contact lenses
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: contact lenses
A Trial With Subcutaneous Immunotherapy (SCIT) in Patients With Rhinoconjunctivitis Sensitized to Olea Europaea and Phleum Pratense
Condition: Rhinoconjuntivitis
Study type: Interventional
Phase: Phase 1

Summary: 
      The study was designed according to the draft of allergenic product regulation published by
      Spanish Regulatory Agency. The aim of the study is to evaluate the safety and tolerability of
      subcutaneous immunotherapy with polimerized (100/100) mixture of pollens: Olea europaea and
      Phleum pratense in patients with rhinoconjunctivitis with or without associated mild asthma.
      In addition, surrogate efficacy parameters will be evaluated: immunoglobulin level changes
      and skin reactivity.
    


Intervention name(s): allergovac polimerized (100/100)
Intervention type(s): Biological
Intervention description(s): Patients will recieve a initiation phase plus a mantenaince phase for 3 months of an allergy vaccine.
Other intervention name(s): Allergovac Poliplus
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: allergy; Immunotherapy; SCIT
Effects of Transcranial Direct Current Stimulation on Cigarette Addiction
Condition: Addiction
MeSH terms: Behavior, Addictive
Study type: Interventional

Summary: 
      Tobacco addiction is treatable with behavioral and pharmacological means, but results are
      often less than optimal. Transcranial direct current stimulation is a new non-invasive
      technique that applies weak electrical currents through the skull and has been shown to alter
      the excitability of certain brain areas. It is currently being tried in disorders where there
      is abnormal brain excitability, such as epilepsy and depression. A few studies have also been
      able to diminish drug craving, suggesting that brain excitability might also be altered in
      drug addiction.

      This study aims at non-invasively changing the excitability of certain brain areas-a
      procedure called neuromodulation- in order to help smokers quit smoking more easily.
    


Intervention name(s): Placebo; Transcranial Direct Current Stimulation
Intervention type(s): Other; Device
Intervention description(s): Transcranial Direct Current Stimulation (tDCS) is a procedure that uses a small battery-driven unit to deliver weak electrical currents (1-2 mA) through the intact scalp. The procedure is painless and is thought to modulate the excitability of the underlying cerebral tissue for hours or days after sessions.
In the placebo group the current will be off.; Transcranial Direct Current Stimulation (tDCS) is a procedure that uses a small battery-driven unit to deliver weak electrical currents (1-2 mA) through the intact scalp. The procedure is painless and is thought to modulate the excitability of the underlying cerebral tissue for hours or days after sessions.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: cigarette smoking, smoking
Human Papilloma Virus Vaccination in Girls With Cystic Fibrosis (VACCIN-HPV-MUC2)
Condition: Mucoviscidosis
MeSH terms: Papilloma; Cystic Fibrosis; Fibrosis
Study type: Observational

Summary: 
      Background The main risk factor for cervical cancer is the infection by human papillomavirus
      (HPV). Vaccination against HPV, offered to all girls aged 11 to 14 is an effective method of
      prevention against cervical pathology. Despite this, vaccination coverage against HPV remains
      low in France. A proportion of women with cystic fibrosis may be involved in transplantation,
      a factor associated with a higher risk of HPV carriage and cervical pathology. An over-risk
      of cervical pathology would also be present in women with non-transplanted cystic fibrosis.
      Particular attention to vaccination should therefore be included in this population.

      Objectives of the study The main objective of the study is to estimate the frequency of HPV
      vaccination in young girls with CF over 9 years and followed in a pediatric CF center.

      The secondary objectives are to know:

        -  The type of vaccine used (bivalent / quadrivalent / nonavalent)

        -  The proportion of vaccinated girls with respect of the vaccination schedule (number of
           injections / spacing between doses)

        -  Reasons for non-use of vaccination

      Study design The study will last 12 months. It is a cross-sectional, non-interventional,
      multicenter conducted by self-administered questionnaire.

      Population

        -  young girls aged 9 years or older with Cystic fibrosis

        -  Followed in a pediatric or mixed CF center in the France (Rhone-Alpes Auvergne Region
           and Ile de France Region)

        -  With parents who did not object to participation in the study

      Number of subject: 62 patients

      Expected results

        -  Knowledge of HPV vaccination coverage in young girls with CF.

        -  Sensitization of patients, their parents and health professionals to HPV vaccination.
           Understand the barriers and reasons for refusing vaccination to promote actions to
           improve immunization coverage.
    


Intervention name(s): Self administrated questionnaire
Intervention type(s): Other
Intervention description(s): Questionnaires are distributed to patients with their parents during their visit to the CF center.
Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Cohort of minor girls with cystic fibrosis older than 9 years, followed in a pediatric
        Mucoviscidosis Resource and Competence Center (MRCC).
      
Keywords: mucoviscidosis; Human Papilloma Virus; Vaccination; Young girl
Bioavailability Study of Famotidine Tablets 40 mg Under Fasting Conditions
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The objective of this study was to compare the single-dose relative bioavailability of Reddy
      Cheminor and Merck &Co, pepcid 40 mg famotidine tablets under fasting conditions.
    

Detailed description: 
      Detailed Description : The study was conducted as an open-label, randomized, single-dose,
      2-way crossover, relative bioavailability study performed on 30 healthy adult male
      volunteers. A total of 30 subjects completed the clinical phase of the study. Single oral 40
      mg doses were separated by a washout period of 7 days.
    

Intervention name(s): Famotidine; Pepcid
Intervention type(s): Drug; Drug
Intervention description(s): Famotidine Tablets 40 mg; 40mg tablets
Other intervention name(s): Reddy Cheminor; Merck & Co.
Intervention MeSH terms: Famotidine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Bioequivalence; famotidine; Crossover
A Trial Investigating the Safety and Effects of One BNT162 Vaccine Against COVID-19 in Healthy Adults
Condition: Covid-19; Protection Against COVID-19
MeSH terms: COVID-19
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Originally, the study was planned to include two parts, i.e., Part A and Part B, however Part
      B was skipped due to changes in the overall clinical development plan. The conducted Part A
      was a dose-finding part to investigate the optimal dose, allowing dose adjustments upwards
      and downwards in younger participants. Doses tested in older participants were chosen based
      on acceptability of dosing in younger participants.
    

Detailed description: 
      This study was a multi-site, Phase I/II, open-label, dose-escalation study. The study
      included the first in human dose and dose ranging groups in healthy younger participants
      (aged 18 to 55 years [yrs]) and older participants (aged 56 to 85 yrs). The conducted Part A
      followed a dose escalation design. Discretionary dose de-escalation and refinement was also
      planned. Study participants with the first-in-human [FIH] immunization and any subsequent
      dose escalation cohorts were immunized using a sentinel dosing/subject staggering. For any
      dose de-escalation or dose-refinement cohorts in younger adults, i.e., cohorts with doses
      lower than previously tested, participants were dosed using a subject staggering process.
      Cohorts in older participants were optional and dependent on acceptability of dosing in
      younger participants. Part A consisted of a treatment phase (screening to Visit 7) and a
      follow-up phase (Visits 8 to 10).
    

Intervention name(s): BNT162b3
Intervention type(s): Biological
Intervention description(s): Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (Prime/Boost (P/B) regimen).
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Protection against COVID-19; Coronavirus; Vaccine; RNA Vaccine; SARS-CoV-2; Coronavirus Disease 2019; Virus Diseases; Coronavirus infection
Inspiratory Muscle Training in Sarcoidosis
Condition: Sarcoidosis
MeSH terms: Respiratory Aspiration; Sarcoidosis
Study type: Interventional

Summary: 
      Respiratory muscle weakness results with decreased exercise capacity, worse fatigue, dyspnea
      and quality of life in patients with sarcoidosis. However, no study investigated the effects
      of inspiratory muscle training (IMT), therefore effects of IMT on outcomes in patients with
      sarcoidosis were investigated.
    

Detailed description: 
      Patients were diagnosed with sarcoidosis according to the criteria of the latest American
      Thoracic Society (ATS)/European Respiratory Society (ERS)/World Association of Sarcoidosis
      and Other Granulomatous (WASOG) Disorders statement on sarcoidosis. Primary outcome
      measurement was respiratory muscle strength, secondary outcomes were, exercise capacity
      quality of life, fatigue and depression.
    

Intervention name(s): Inspiratory muscle training; Sham inspiratory muscle training
Intervention type(s): Device; Device
Intervention description(s): Treatment group received inspiratory muscle training (IMT) using threshold loading device (POWERbreathe Classic, IMT Technologies Ltd. Birmingham, England) at 40% of maximal inspiratory pressure (MIP).
The MIP was measured at supervised session each week, and 40% of measured MIP value was the new training workload.
The treatment group trained for 30 min-per/day, 7 days/week, for 6 weeks. Six sessions at home and 1 session were performed at department.; Control group received sham inspiratory muscle training (IMT) at fixed workload, 5% of MIP using threshold loading device (POWERbreathe Classic device IMT Technologies Ltd. Birmingham, England).
The control group trained for 30 min-per/day, 7 days/week, for 6 weeks. Six sessions at home and 1 session were performed at department.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: sarcoidosis; inspiratory muscle strength; exercise capacity; quality of life
Aripiprazole and Prolactin Study
Condition: Hyperprolactinemia
MeSH terms: Hyperprolactinemia
Study type: Interventional
Phase: Phase 4

Summary: 
      Antipsychotic medicines are used routinely in people with severe mental illness or learning
      disability. Antipsychotics often induce hyperprolactinemia (high prolactin level) and in
      almost all women, and some men, this causes hypogonadism (impaired ovarian or testicular
      function)often with osteoporosis, partly explaining psychiatric patients' high fracture risk.
      Reducing prolactin by changing antipsychotic or adding a dopamine agonist often worsens
      psychosis. Adding aripiprazole to current antipsychotic normalizes prolactin in adult
      schizophrenic patients, without serious side effects. We thus plan a study of add-on
      aripiprazole in people with antipsychotic induced hyperprolactinemia.

      Our main hypothesis is that aripiprazole will normalize or reduce prolactin sufficiently to
      restore normal ovarian and testicular function. Our secondary hypothesis is that restoration
      of normal ovarian and testicular function will improve bone mineral density in patients in
      whom this was reduced at the time of entry into the study.
    


Intervention name(s): Aripiprazole
Intervention type(s): Drug
Intervention description(s): Aripiprazole will be started at 5 mg daily and increased in a treat-to-target fashion by 5 mg steps until the primary outcome or the maximum tolerated or permitted dose of 30 mg is reached
Other intervention name(s): Abilify
Intervention MeSH terms: Aripiprazole
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Antipsychotic; hyperprolactinemia; hypogonadism; aripiprazole
Safety and Efficacy of Cellcept and Avonex as Combination Treatment in Multiple Sclerosis
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis
Study type: Interventional
Phase: Phase 2

Summary: 
      The primary objective of this safety/mechanistic study is to determine the safety and
      tolerability of oral Cellcept when compared with weekly intramuscular Avonex in relapsing
      multiple sclerosis. Safety will be assessed by virtue of changes in size and number of
      lesions on MRI scans.
    

Detailed description: 
      Sixty patients (20 patients at each recruiting center) with RR MS who satisfy both inclusion
      and exclusion criteria will be treated with CellCept® or Avonex® for the first 6 months of
      the study. Those patients will have a fifty-fifty chance of receiving either Avonex or
      Cellcept. Baseline data will be collected before treatment begins including MRIs, chest
      x-ray, EKG, and standard labwork, along with a blood test for HIV and Hepatitis B. Once
      enrolled, study visits include periodic MRI scans, a neurological exam by the examining
      neurologist every three months, frequent bloodwork, questionnaires, and eye-testing at month
      zero, six, and twelve months. Eye testing takes about one hour and requires dilation of
      pupils. All assessments are standard of care for ophthalmology with the exception of optical
      coherence tomography (OCT)-- a non-invasive procedural device that records graphical and
      numerical measurements of the optic nerve and macula.

      All patients will begin active combination therapy on both CellCept® and Avonex® during the
      second 6 months of the study. During this second phase, MRI and clinical examinations will be
      performed.
    

Intervention name(s): Mycophenolate Mofetil (CellCept)
Intervention type(s): Drug
Intervention MeSH terms: Mycophenolic Acid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Quetiapine XR Versus Sertraline in Acute Bipolar Depression as add-on Therapy
Condition: Bipolar Disorder; Bipolar Depression
MeSH terms: Depression; Depressive Disorder; Bipolar Disorder
Study type: Interventional
Phase: Phase 3

Summary: 
      Prospective, open-label, controlled (active comparator), randomized study of 8 weeks
      follow-up for the evaluation of the efficacy of extended release quetiapine (quetiapine XR)
      versus Sertraline in addition to previous mood stabilizer treatment (lithium or valproate at
      stable and clinically therapeutic blood levels) in the treatment of the adult bipolar
      depression. This multicentric study will be featured in two sites in Spain.
    


Intervention name(s): Extended release quetiapine (quetiapine XR); Sertraline; adequate mood stabilizer
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Flexible dose from 300 to 600 mg/d (combination of tablets of 50mg, 200mg and 300mg) oral, daily, 8 weeks length.
Quetiapine XR was initiated at 50 mg/day and titrated to 100 mg on day 2, 200 mg on day 3, 300 mg on day 4, and flexible doses of 300 to 600 mg/d from day 5 to the end of the study.; Flexible dose from 50 to 200 mg/d (combination of tablets of 50mg and 100mg) oral, daily, 8 weeks length.
Sertraline titration: 50 mg on day 1-3, 100 mg on day 4, and flexible doses of 50 to 200 mg/d from day 5 to the end of the study.; An adequate mood stabilizer treatment with lithium or valproate(defined as a serum concentration of 0.5-1.2 mEq/L or 50-100 microg/ml, respectively).
Other intervention name(s): SEROQUEL XR®; Zoloft
Intervention MeSH terms: Quetiapine Fumarate; Sertraline
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Bipolar disorder; Bipolar depression; quetiapine; sertraline