bioihbjkbjnl/mcl2 huggingface dataset:
An Open-Label Trial of Losartan Potassium in Participants With Eosinophilic Esophagitis (EoE)
Condition: Eosinophilic Esophagitis
MeSH terms: Esophagitis; Eosinophilic Esophagitis
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to test the safety and effectiveness of Losartan potassium in
      subjects with eosinophilic esophagitis (EoE) including those with a connective tissue
      disorder (CTD) and those without a CTD.
    

Detailed description: 
      The purpose of this research study is to test the safety and effects (good and bad) of
      Losartan potassium on participants with eosinophilic esophagitis (EoE). If a participant has
      a connective tissue disorder (CTD) the researchers want to see what effects (good or bad)
      Losartan has on EoE.

      EoE is an inflammatory disease of the esophagus that is typically triggered by exposure to
      food. Connective tissue disorders (CTDs) are disorders that affect the connective tissues in
      the body such as tendons and ligaments.

      A protein called transforming growth factor (TGF)-beta is associated with both EoE and CTD.
      Losartan may decrease the amount of TGF-beta and therefore help EoE and CTD.

      Losartan is a drug that is approved by the United States Food and Drug Administration (FDA)
      for use in adults and children over 6 years of age who have high blood pressure. This
      medication has not been studied in people with EoE.
    

Intervention name(s): Losartan Potassium
Intervention type(s): Drug
Intervention description(s): Losartan potassium
Other intervention name(s): Losartan
Intervention MeSH terms: Losartan
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: This study is an open-label study which means that all participants receive the study medicine.
Masking: None (Open Label)
Primary purpose: Treatment
Multiple Dose Study of D1971a in Healthy Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a randomised, double-blind, placebo-controlled multiple dose study designed to
      explore the safety, tolerability and PK of DS-1971a following oral administration over 14
      days to healthy male and female subjects. Each participant receives lidocaine as a local
      anaesthetic before inserting the intravenous cannula.
    

Detailed description: 
      Within strictly defined limits, the protocol permits the dose escalation committee to amend
      the dose escalation rules, doses proposed in the study protocol and to change the timing of
      or to add additional assessments following review of the safety, tolerability and plasma
      DS-1971a concentration data. The decisions to change the doses will be documented in the
      minutes of the dose escalation committee.
    

Intervention name(s): DS-1971a; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): DS 1971a is supplied as a powder or crystals and will be given as an oral suspension; Placebo matching DS-1971a suspension
Intervention MeSH terms: DS-1971a
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: pharmacokinetics
PrEP, Lube, and the Rectal Mucosa in MSM at Risk of HIV
Condition: HIV
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to determine whether the use of rectal lubricants can affect how
      well the medication, Truvada, will work to prevent infection with HIV when someone is exposed
      to HIV in the rectum.
    

Detailed description: 
      Men who have sex with men (MSM) continue to be disproportionately affected by HIV. The
      majority of HIV infections among MSM occur through exposure to the rectal mucosa during
      receptive anal intercourse (RAI). During RAI, many MSM will use lubricants, which can
      potentially cause mucosal inflammation and damage. A new HIV prevention intervention, called
      pre-exposure prophylaxis (PrEP), recommends that MSM at risk of HIV infection take a daily
      anti-HIV medication called Truvada (tenofovir/emtricitabine) which is highly effective.
      However, it is not known if the use of lubricant during RAI will interfere with the efficacy
      of PrEP for HIV prevention.
    

Intervention name(s): Truvada; Gel lubricant
Intervention type(s): Drug; Device
Intervention description(s): Truvada is a combination of 200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate taken orally.; Five ml of an over the counter sexual lubricant will be dispensed using an applicator.
Other intervention name(s): Emtricitabine; Tenofovir
Intervention MeSH terms: Tenofovir; Emtricitabine; Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Human Immunodeficiency Virus; Acquired Immune Deficiency Syndrome Virus; Pre-exposure Prophylaxis
Diaphragm Pacing in Individuals With Spinal Cord Injuries
Condition: Cervical Spinal Cord Injury
MeSH terms: Spinal Cord Injuries; Wounds and Injuries
Study type: Observational

Summary: 
      This project will evaluate the effects of intramuscular diaphragm stimulation (pacing) and
      test the hypothesis that diaphragm pacing enhances neuromuscular diaphragm activation and
      respiratory function in adults with cervical spinal cord injuries (C-SCIs). The investigators
      will test the hypothesis by recording activity of the diaphragm from intramuscular pacing
      electrodes and conduct respiratory assessments in adults with intramuscular diaphragm pacing
      electrodes following acute, traumatic C-SCIs.
    

Detailed description: 
      Respiratory dysfunction is a leading cause of death in individuals with spinal cord injuries
      (SCIs). Nearly one-quarter of all SCI cases involve injury to the upper spinal cord segments
      which impairs neural activation of the diaphragm muscle and compromises breathing. Although
      mechanical ventilation can be life-saving after cervical SCI (C-SCI), it also triggers rapid
      and profound diaphragm muscle atrophy, thereby complicating (or even preventing) ventilator
      weaning. Intramuscular diaphragm stimulation, or diaphragm pacing, was developed to replace
      long-term ventilator support and is now used acutely post C-SCI (<4 months following injury)
      to promote ventilator weaning. This study will assess the effects of diaphragm stimulation on
      respiratory neural drive and breathing function in individuals with acute, traumatic C-SCI.
      Recording from these surgically implanted electrodes allows comparisons of electromyogram
      (EMG) recordings, in association with respiratory assessments, before and after short periods
      of diaphragm pacing to isolate the unique contribution of diaphragm pacing on neuromuscular
      diaphragm activation.
    

Intervention name(s): Diaphragm Pacing
Intervention type(s): Device
Intervention description(s): Intramuscular stimulation of the diaphragm, or diaphragm "pacing' is achieved by laparoscopic placement of stimulation wires into each hemidiaphragm. Phrenic motor points on the diaphragm are mapped to optimize electrode placement. The electrodes are threaded into the diaphragm muscle and wire leads are externalized and attached to a stimulation controller.
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients with acute, traumatic C-SCIs, scheduled to receive intramuscular diaphragm pacing
        OR who have recently received a diaphragm pacer (within past 5-days) will be recruited from
        UF Health Shands Jacksonville, a Level-1 trauma hospital serving North Florida.
      
Keywords: SCI; diaphragm pacing; respiratory impairment; diaphragm stimulation
To Evaluate the Use of ASTHMA IQ in a Primary Care Setting
Condition: Asthma
MeSH terms: Asthma
Study type: Observational

Summary: 
      There is a mounting body of evidence suggesting that there is a large disparity between the
      development and the actual implementation of guideline-driven asthma care in primary and
      specialty care practices. To address this disparity, the American Academy of Allergy, Asthma
      & Immunology (AAAAI) developed a unique, comprehensive and easy-to-use Web-based tool for
      clinicians who treat asthma patients called "Asthma Specialist Tool to Help Manage Asthma and
      Improve Quality" (Asthma-IQ). This study will examine whether the use of the Asthma IQ
      primary care tool will improve asthma care and asthma outcomes using a randomized trial of
      the Asthma IQ system versus usual asthma care in the primary care setting over 1 year. At the
      end of 1 year, all patients will be managed using the Asthma-IQ tool for an additional year
      to determine if the patients managed by usual care in the first year improve when managed in
      conjunction with Asthma-IQ. The primary endpoint to determine if the use of the Asthma IQ
      tool will improve asthma patient outcomes is quarterly assessments of Asthma Control Test
      (ACT) scores via automated / electronic patient survey. The secondary endpoint is asthma
      exacerbations and there are a number of exploratory endpoints to further define the clinical
      utility of the primary care version of Asthma-IQ. This study will involve recruiting
      approximately 20 family medicine offices with approximately 20 patients each, to conduct this
      randomized, multiple time point intervention trial. The necessary total recruited patient
      sample size is 200 per group. The results of this study will help determine the utility of
      Web-based tools to help manage chronic diseases such as asthma.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        The study will recruit approximately 400 patients with chronic persistent asthma. The
        required sample size to identify a clinically significant difference in ACT scores from
        baseline and between groups requires about 200 patients per group.
      
Keywords: Asthma; ASTHMA IQ tool; Asthma Control Test (ACT); EPR-3 Guidelines, Exacerbations
Pimavanserin for Insomnia In Veterans With Posttraumatic Stress Disorder
Condition: Post-traumatic Stress Disorder; Insomnia
MeSH terms: Sleep Initiation and Maintenance Disorders; Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
Study type: Interventional
Phase: Phase 4

Summary: 
      This preliminary, open-label study assesses the feasibility of 34mg at bedtime for 6 weeks in
      Veterans with Posttraumatic Stress Disorder and insomnia.
    

Detailed description: 
      More treatments are needed to target insomnia in Veterans with Posttraumatic Stress Disorder.
      There is evidence to suggest that pimavanserin, a medication approved by the Food and Drug
      Administration for the treatment of psychosis in Parkinson's disease, may improve deep sleep
      and insomnia. This study preliminary assesses the feasibility of pimavanserin 34mg at bedtime
      for 6 weeks for the treatment of chronic insomnia in Veterans with Posttraumatic Stress
      Disorder.
    

Intervention name(s): Pimavanserin
Intervention type(s): Drug
Intervention description(s): pimavanserin tablet
Other intervention name(s): Nuplazid
Intervention MeSH terms: Pimavanserin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Post-traumatic Stress Disorder; Insomnia
A Study Of A New Medicine (GW597599B) For The Treatment Of Major Depressive Disorder
Condition: Depressive Disorder, Major
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Study type: Interventional
Phase: Phase 2

Summary: 
      A Placebo Controlled Study Evaluating Efficacy And Safety of Medication In Patients With
      Major Depressive Disorder (MDD)
    


Intervention name(s): GW597599B; paroxetine
Intervention type(s): Drug; Drug
Other intervention name(s): GW597599B
Intervention MeSH terms: Paroxetine; Vestipitant
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Depression; Psychiatry; Major Depressive Disorder
Management Strategy for Mild to Moderate Major Depression: Combination of Rhodiola and Saffron Extracts.
Condition: Mild to Moderate Depression
MeSH terms: Depression; Depressive Disorder
Study type: Observational

Summary: 
      The purpose of the study is to describe, over 6 weeks, the evolution of depressive symptoms
      in patients with mild to moderate major depression in a strategy with Phytostandard®
      Rhodiola-Saffron supplementation
    

Detailed description: 
      For this study, 52 patients are going to be included. They will have a supplementation of
      Phytostandard® rhodiola/saffron, from 2 tablets per day during 42 days.

      on the one hand, during the two visits (inclusion and follow-up), the investigator completes
      the Hamilton Depression Scale (HAM-D) and the Clinical Global Impression (CGI). During the
      inclusion visit, he completes with his patient CIM-10 for depression diagnostic.

      on the other hand, patients complete HAD 4 times : just after the inclusion visit, at day 14,
      at day 28 and just before the follow-up visit. He completes the Patient Global Impression too
      at each time.
    

Intervention name(s): Phytostandard® Rhodiola-Saffron
Intervention type(s): Dietary Supplement
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Patients suffering from mild to moderate depression
Non-heme Iron Absorption From Single Meals of Fava Bean Protein, Beef Protein and Cod Protein
Condition: Healthy; Nutrition, Healthy
Study type: Interventional

Summary: 
      The aim of this study is to investigate the non-heme iron absorption from single meals of
      texturized fava bean protein, which has been suggested as a protein source suitable for
      replacement of meat, compared to the non-heme iron absorption from beef protein and cod
      protein meals. The study participants are women of fertile ages, which is one of the main
      groups at risk of developing iron deficiency. Since a dietary shift towards increasingly
      plant based is being pushed, investigating nutritional effects of such a shift is essential
      to avoid potential negative effects such as an increase of nutritional deficiencies. The
      study includes two cross-over single-blinded iron isotope trials in apparent healthy Swedish
      women of the ages 18-45 years, each of whom served as their own control. Participants will be
      served matched test meals containing beef and fava bean protein (Study 1), or cod and fava
      bean protein (Study 2) with radiolabeled non-heme iron 55Fe and 59Fe. Absorption of non-heme
      iron from test meals will be measured by whole-body counting, and erythrocyte incorporation
      by liquid scintillation.
    


Intervention name(s): Single meal non-heme iron absorption
Intervention type(s): Other
Intervention description(s): Two study groups, each designed as cross-over single-blinded iron isotope trials in apparent healthy Swedish women of the ages 18-45 years. Each participant serves as their own control. Meals are tagged with radiolabeled non-heme iron 55Fe and 59Fe.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Other
Influence of Breakfast Consumption on Chlorogenic Acid Metabolism in Humans
Condition: Healthy
Study type: Interventional

Summary: 
      Data and knowledge gathered on bioavailability of coffee phenolics is becoming more and more
      important, hence underlying the importance of better understanding the fate of these
      potential health promoting antioxidants. However, some analytical barriers as well as some
      key aspects of metabolism still remain to be fully elucidated to get the full picture of
      coffee metabolism and bioavailability. One aspect addressed in the present study is the
      impact of food matrix in modulating absorption, plasma appearance and urinary excretion of
      coffee bioactives.
    


Intervention name(s): Soluble Coffee
Intervention type(s): Other
Intervention description(s): Amounts of chlorogenic acids will be normalized to body weight (3.1 mg CA / kg BW). Coffee will be reconstituted in 200 mL hot water and consumed 3 times in a row (min 1-week interval), alone or with a breakfast:
200 mL coffee or
200 mL coffee + 2 bread rolls + honey
200 mL coffee + 1 bread roll + peanut butter
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Atezolizumab in Combination With Bevacizumab in Patients With Unresectable Locally Advanced or Metastatic Mucosal Melanoma
Condition: Melanoma
MeSH terms: Melanoma
Study type: Interventional
Phase: Phase 2

Summary: 
      This study will evaluate the efficacy and safety of atezolizumab in combination with
      bevacizumab in patients with unresectable locally advanced or metastatic mucosal melanoma.
    

Detailed description: 
      The study is divided into 2 stages. Stage I of the study is completed when 22 patients with
      measurable disease have been enrolled and completed ORR evaluation. If the number of
      responders in Stage I is more than 3, another 16 patients may be enrolled to Stage II.
    

Intervention name(s): Atezolizumab; Bevacizumab
Intervention type(s): Drug; Drug
Intervention description(s): Atezolizumab 1200 mg will be administered intravenously every 3 weeks.; Bevacizumab 7.5 mg/kg will be administered intravenously every 3 weeks.
Other intervention name(s): Tecentriq; Avastin
Intervention MeSH terms: Bevacizumab; Atezolizumab
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Efficacy of Seroquel SR in Combination With an Antidepressant in Treatment of Major Depressive Disorder
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Study type: Interventional
Phase: Phase 3

Summary: 
      To evaluate the efficacy and safety of quetiapine fumarate sustained release (Seroquel SR) in
      the treatment of Major Depressive Disorder.

      PLEASE NOTE: Seroquel SR and Seroquel XR refer to the same formulation. The SR designation
      was changed to XR after consultation with FDA.
    


Intervention name(s): Quetiapine SR; Escitalopram
Intervention type(s): Drug; Drug
Intervention MeSH terms: Quetiapine Fumarate; Escitalopram
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Major Depressive Disorder; MDD
Postpartum Wellness
Condition: Postpartum Depression
MeSH terms: Depression, Postpartum; Depression; Depressive Disorder
Study type: Interventional

Summary: 
      The purpose of this study is to test whether a web-based (eHealth) exercise intervention for
      new moms at increased risk for postpartum depression increases physical activity and
      decreases postpartum depression symptoms.
    

Detailed description: 
      Postpartum depression is a debilitating and costly condition that is associated with
      significant health consequences for mothers and children. Counseling for prevention of
      postpartum depression is currently recommended in women at high risk of postpartum
      depression; however, there is a shortage of mental health care providers. There is a need for
      effective interventions to prevent postpartum depression that can be easily integrated into
      health care systems, yet do not involve intense health care system resources. eHealth
      interventions are promising in this regard.

      Strong evidence suggests physical activity can reduce depression risk. This study will assess
      the effectiveness of an eHealth exercise intervention tailored to postpartum mothers for
      increasing physical activity levels and improving depressive symptoms in women at increased
      risk of postpartum depression. This intervention addresses several identified barriers to
      physical activity in postpartum women. The study will randomize 200 women to receive an
      eHealth exercise intervention for postpartum women or usual postpartum care. Device-based
      physical activity and depressive symptoms will be measured at 3 and 6 months after
      randomization.
    

Intervention name(s): Exercise intervention
Intervention type(s): Behavioral
Intervention description(s): eHealth exercise intervention for postpartum women at increased risk of depression
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Prevention
Keywords: Exercise; Postpartum Depression; Physical activity; eHealth intervention
Clinical Feasibility and Efficacy of Intermittent Use of a Fasting Mimicking Diet in the Treatment of Type 2 Diabetes
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      In this randomized, controlled, assessor blinded and prospective intervention study the
      investigators will evaluate the clinical feasibility and effectiveness of intermittent use of
      a fasting mimicking diet in patients with type 2 diabetes mellitus compared to usual care.
    

Detailed description: 
      100 individuals (men or women, ethnicity not specified) with type 2 diabetes and a BMI≥ 27,
      who are treated with diet only and have a HbA1c > 48, or who are treated with diet and a dose
      of metformin can participate in the study. Participants will use a fasting-mimicking diet for
      5 consecutive days per month. For the other days, there are no regulations. During follow-up
      of one year, several study parameters will be measured including HbA1c and antidiabetic
      medication dosage.
    

Intervention name(s): Fasting Mimicking diet
Intervention type(s): Other
Intervention description(s): The fasting mimicking diet is though to activate the metabolism as fasting would do, although the diet does include several meals a day and more calories than conventional fasting diets.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Patients will be randomised to the intervention or control group.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Diet; Fasting
Effects of Herbal Products on Reduction of Radiation-induced Dermatitis in Breast Cancer Patients
Condition: Radiodermatitis; Breast Neoplasms; Adverse Effect of Radiation Therapy
MeSH terms: Breast Neoplasms; Dermatitis; Radiodermatitis
Study type: Interventional

Summary: 
      The herbal products on reduction of radiation-induced dermatitis in patients with breast
      cancer
    

Detailed description: 
      To compare the effect of each herb extracts to protect the skin from the adverse effects of
      radiation therapy in patients with breast cancer with herbal extract products.
    

Intervention name(s): Control; Cucumber cream; Centella cream; Thunbergia cream
Intervention type(s): Other; Other; Other; Other
Intervention description(s): Apply moisture cream to the treatment skin everyday after radiation therapy; Apply cucumber cream to the treatment skin everyday after radiation therapy; Apply centella cream to the treatment skin everyday after radiation therapy; Apply thunbergia cream to the treatment skin everyday after radiation therapy
Other intervention name(s): Centella asiatica; Thunbergia laurifolia Lindl
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Prevention
Keywords: herbal products; reduction of radiation-induced dermatitis; breast cancer; radiotherapy