bioihbjkbjnl/mcl2 huggingface dataset:
ARENA - Project Atrial Fibrilation Rhine-Neckar Region
Condition: Atrial Fibrillation
MeSH terms: Atrial Fibrillation
Study type: Observational [Patient Registry]

Summary: 
      ARENA aims to inform patients about the symptoms and the risks of atrial fibrilation.

      The study design includes three study arms:

        1. ARENA Intervention: This project will examine the effectiveness of population education.

        2. ARENA Medication: The aim is to examine the patient's adherence and to analyze whether
           there are any complications.

        3. ARENA Migration: ARENA migration aims to examine whether a targeted population education
           can improve the care of people with a Turkish migration background.
    

Detailed description: 
      ARENA aims to inform patients about the symptoms and the risks of atrial fibrilation.

      The study design includes three study arms:

        1. ARENA Intervention:

           This project will examine the effectiveness of population education and other measures
           to provide care for patients with atrial fibrillation.

           In the end of the control phase (1 year recruitment of approximately 10,000 patients),
           there will be a wide publicity, informing about the disease.

        2. ARENA Medication:

           ARENA records the patient's complete medication at all survey times (up to two weeks
           after recruitment and follow up). This allows an accurate assessment of interactions
           between individual substances.

           In addition, attempts are being made to determine drug concentrations of anticoagulants
           directly by the blood of the patient. Therefore, patients are provided with kits, which
           they can use to apply a drop of blood from your fingertip to a filter paper. The aim is
           to examine the patient's adherence and to analyze whether there are any complications.

        3. ARENA Migration:

      The Metropolregion Rhein-Neckar is characterized by a high proportion of people with a
      Turkish migration background. ARENA migration aims to examine whether a targeted population
      education can improve the care of this patient group.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Patients with atrial fibrilation in the Rhein-Neckar Region in Germany, recruted by their
        general practitioner or during a hospital stay.
The Use of Metformin in the Treatment of Antipsychotic-Induced Weight Gain in Schizophrenia (The METS Study)
Condition: Schizophrenia
MeSH terms: Weight Gain; Schizophrenia
Study type: Interventional
Phase: Phase 4

Summary: 
      This study will test the usefulness of the medication metformin in treating people with
      schizophrenia or schizoaffective disorder who are overweight and also taking antipsychotic
      medications.
    

Detailed description: 
      Schizophrenia is a chronic mental disorder that is characterized, in part, by psychotic
      symptoms. Psychotic symptoms include hallucinations and delusions, in which a person has
      abnormal experiences or beliefs, and are commonly treated with antipsychotic medications.
      Unfortunately, a side effect of many antipsychotics is unwanted weight gain, which can lead
      to physical illness. Use of the drug metformin has resulted in weight loss among diabetics.
      Metformin has also been shown to cause weight loss in preliminary studies of people taking
      atypical antipsychotics-a newer, second generation of antipsychotic medications. Metformin is
      currently approved by the Food and Drug Administration to treat only people with diabetes.
      This study will test the usefulness of prescribing metformin as a second medication to treat
      people with schizophrenia or schizoaffective disorder who are overweight and taking
      antipsychotics. The study will also provide important feasibility information for future
      larger studies.

      Participation in this study will last 16 weeks. After undergoing baseline assessments,
      participants will be randomly assigned to receive either metformin or placebo, both of which
      will be taken twice daily for the duration of the study. All participants will also receive
      behavioral therapy that will teach them about reducing their weight through diet and
      exercise. Participants will undergo assessments at 11 study visits: the first 2 will include
      screening and baseline testing, the next 2 visits will take place after the first and second
      weeks of receiving treatment, and the last 7 visits will take place every 2 weeks until the
      end of the study. Assessments will include measurements of body weight, waist-to-hip ratio,
      and vital signs; clinical interviews about medication adherence, side effects, and alcohol
      use; and monthly blood tests to assess levels of lipids, glucose, insulin, and hemoglobin
      A1c.
    

Intervention name(s): Metformin; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 500 mg to 1,000 mg taken twice daily for 16 weeks; 1 to 2 placebo capsules taken twice daily for 16 weeks
Other intervention name(s): Glucophage
Intervention MeSH terms: Metformin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Schizoaffective Disorder
A Study of RSLV-132 in Subjects With Primary Sjogren's Syndrome
Condition: Sjogren's Syndrome
MeSH terms: Sjogren's Syndrome; Syndrome
Study type: Interventional
Phase: Phase 2

Summary: 
      The present study will examine the role of circulating RNA complexed with autoantibodies and
      immune complexes and its role in activation of inflammatory pathways in patients with primary
      Sjogren's syndrome. The study will be conducted in a subset of Sjogren's patients who have
      elevated levels of autoantibodies and a pattern of elevated interferon-stimulated gene
      expression in blood cells. A number of biochemical and clinical parameters will be analyzed
      to determine the potential therapeutic utility of nuclease therapy in Sjogren's syndrome.
    

Detailed description: 
      This is a multi-center, double-blind, placebo-controlled study to evaluate the impact of 8
      intravenous infusions of RSLV-132 in 28 patients with primary Sjogren's syndrome. Each of the
      subjects will be randomized 3:1 (active:placebo) and will receive 8 infusions of 10 mg/kg of
      RSLV-132 or placebo as follows on days:

      • 1, 8, 15, 29, 43, 57, 71, and 85

      Potential subjects will be screened to assess their eligibility to enter the study within 60
      days prior to study entry (i.e., prior to Baseline visit). Following Baseline evaluations on
      Day 1, subjects will receive their first infusion of RSLV-132 or placebo. Subjects will
      return to the research unit for follow-up visits as described in Appendix A.

      Dose selection rationale: The dose level was chosen based on safety and tolerability data
      from Protocol 132-02 (multiple ascending dose study in SLE patients). Additionally, in a
      6-month toxicology study in cynomolgus monkeys, 50 mg/kg of RSLV-132 was administered by IV
      infusion weekly. No dose-limiting toxicity was noted, therefore the No Observed Adverse
      Effect Level is at least 50 mg/kg, providing at least a 5-fold safety margin for this study.

      RSLV-132 shall be prepared for each subject from individual stock vials provided by Sponsor.
      Details of dilution, dose preparation, and administration instructions will be provided in
      the Study Drug Reference Guide. The dose for each individual shall be based on the subject's
      body weight.
    

Intervention name(s): RSLV-132; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): RNase Fc fusion protein; Placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Millet Products Study - Investigation of Glycemic Index and Satiety
Condition: Hyperglycemia; Lack of Satiety
MeSH terms: Hyperglycemia
Study type: Interventional

Summary: 
      The purpose of this study is to investigate how millet incorporation into different baked
      product types influences glycemic response and satiety.
    

Detailed description: 
      The purpose of this study is to investigate how millet incorporation into different baked
      product types (i.e. an extruded snack versus a biscuit) influences glycemic response and
      satiety.

      This project will examine the effect of millet, on glycemic response and satiety. To
      determine the effect of product matrix and processing methods, testing will be done using an
      extruded snack, porridge, a couscous-like product and a biscuit.

      All product servings will provide 50 g of available carbohydrate and will be consumed by
      participants within 10 minutes.
    

Intervention name(s): Commercial white bread; Corn based products (porridge etc.); Millet based products (porridge etc.)
Intervention type(s): Other; Other; Other
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Double GnRH Antagonist Daily Dose in Hyperresponding IVF/ICSI Cycles May Prevent the OHSS
Condition: Ovarian Hyperstimulation Syndrome
MeSH terms: Ovarian Hyperstimulation Syndrome
Study type: Observational

Summary: 
      The possibility to prevent the early ovarian hyperstimulation syndrome (OHSS) by doubling the
      daily dose of GnRH-antagonist in women stimulated with the antagonist protocol who are at
      risk for OHSS was evaluated. Thirty-eight women of a study group who underwent ovarian
      stimulation using the GnRH-antagonist protocol and might have had their cycle cancelled
      because of OHSS were compared to 76 women of a control group. All cases of the study group
      were IVF women presenting a rapid rise of E2 ≥ 3500 pg/ml on the 7th day of stimulation or
      later while the follicles (> 12mm) were > 15 in total and the biggest one was ≤ 16mm in
      diameter. By decreasing the rFSH dose to 100IU a day and adding an additional dose of
      GnRH-antagonist (0.25 twice a day), estradiol levels were lowered or reached a plateau before
      hCG was given. A marked decrease or plateau of estradiol levels was observed the day of
      oocyte retrieval while the pregnancy rate was not adversely affected when compared with an
      optimum ovarian response cycles. None of the women were cancelled or developed OHSS.

      In overresponding IVF cycles, doubling the usual GnRH-antagonist daily-dose during the
      ovarian stimulation, the estradiol rise could be blocked while a minimal follicular
      stimulation may continue without the risk of OHSS or adversely affect pregnancy rate.
    


Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        PILOT STUDY
      
Keywords: GnRH antagonists; OHSS; ovarian stimulation
Drug-Drug Interaction Study of Vadadustat With Digoxin, Adefovir and Furosemide
Condition: Drug Interaction Potentiation
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a Phase 1, open-label, 3-arm, fixed sequence, study to evaluate vadadustat as a
      perpetrator of drug-drug interactions (DDIs) with digoxin, adefovir and furosemide in healthy
      male and female subjects.
    

Detailed description: 
      This is a Phase 1, open-label, 3-arm, fixed sequence, study to evaluate vadadustat as a
      perpetrator of drug-drug interactions (DDIs) with digoxin, adefovir and furosemide in healthy
      male and female subjects. Unique subjects will be enrolled into each arm of the study and
      enrollment will be sequential. The first 20 subjects confirmed to be eligible will be
      assigned to Arm 1 (digoxin), the next 16 subjects will be assigned to Arm 2 (adefovir) and
      the next 22 subjects will be assigned to Arm 3 (furosemide). Blood samples for PK analysis
      will be collected at pre-defined timepoints for each arm throughout the study. Subjects will
      be on study for up to 80 days, including a 28-day screening period, 7-21 day in clinic
      period, and a 30-day follow up period post last dose.
    

Intervention name(s): Vadadustat; Furosemide; Adefovir; Digoxin
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Oral dose 600 mg; Oral Furosemide; Oral Adefovir; Oral Digoxin
Other intervention name(s): AKB 6548
Intervention MeSH terms: Adefovir; Digoxin; Furosemide
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Intervention model description: Each arm has fixed sequence design.
Arm 1 (n = 20): Digoxin 0.5 mg alone, vadadustat 600 mg alone and digoxin + vadadustat
Arm 2 (n = 16): adefovir 10mg alone, vadadustat 600 mg QD alone and adefovir + vadadustat
Arm 3 (n=22) : furosemide 40mg alone, vadadustat 600 mg QD alone, and furosemide + vadadustat
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: vadadustat; drug interactions; healthy volunteers
IMT in Ventilatory Muscle Metaboreflex in COPD
Condition: Chronic Obstructive Pulmonary Disease
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Study type: Interventional

Summary: 
      This research intends to evaluate if inspiratory muscle training (IMT) reduces inspiratory
      muscle metaboreflex through the decrease of calf vascular resistance and increase of calf
      blood flow in Chronic Obstructive Pulmonary Disease (COPD).
    

Detailed description: 
      Patients will be selected from the Hospital de Clinicas de Porto Alegre's COPD ambulatory, by
      convenience. Afterwards, patients will be submitted to pulmonary function test (spirometry)
      and cardiopulmonary exercise tests (incremental and submaximal), maximal inspiratory pressure
      evaluation and induction of the inspiratory muscle metaboreflex through venous occlusion
      plethysmography. Disease specific health related quality of life questionnaire (Saint George
      Respiratory Questionnaire) and daily life dyspnea questionnaire (Baseline Dyspnea Index and
      Transitional Dyspnea Index) will be administered at the first and last visit of each subject.
      Patients will undergo inspiratory muscle training for 30 minutes per day, 7 times a week, for
      8 weeks, with Inspiratory Muscle Trainer device (PowerBreath Inc.). There will be a weekly
      follow up at the institution's Clinical Research Center, where maximal inspiratory pressure
      (PImax) and inspiratory training techniques will be reevaluated. After this period, tests of
      pulmonary function, questionnaires exercise tolerance and induction of the inspiratory muscle
      metaboreflex will be reevaluated.
    

Intervention name(s): Inspiratory Muscle Training; SHAM
Intervention type(s): Other; Other
Intervention description(s): Patients will receive IMT for 30 min, 7 times per week, for 8 weeks using Inspiratory Muscle Trainer device (PowerBreath Inc.). During training, patients will be instructed to maintain diaphragmatic breathing, with a breathing rate at 15 to 20 breaths/min. Inspiratory load was set at 30% of maximal static inspiratory pressure, and weekly training loads were adjusted to maintain 30% of the PImax. Each week, six training sessions were performed at home and one training session was supervised at the hospital.; Patients will receive SHAM training for 30 min, 7 times per week, for 8 weeks using Inspiratory Muscle Trainer device (PowerBreath Inc.) without load. Patients will be instructed to maintain diaphragmatic breathing, with a breathing rate at 15 to 20 breaths/min. Each week, six training sessions were performed at home and one training session was supervised at the hospital.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Pulmonary Rehabilitation; Inspiratory Muscle Training; Inspiratory Muscle Strength; Vascular Resistance; Exercise; Chronic Obstructive Pulmonary Disease
Effectiveness of Zinc Supplementation in Management of Patients With Symptomatic Benign Migratory Glossitis
Condition: Benign Migratory Glossitis
MeSH terms: Glossitis; Glossitis, Benign Migratory
Study type: Interventional
Phase: Phase 4

Summary: 
      Effectiveness of Zinc Supplementation in management of patients with symptomatic Benign
      Migratory Glossitis.

      Zinc supplements seems to be a therapeutic option as Migratory glossitis is a chronic disease
      knowing that it needs no treatment. Zinc deficiency can probably be a causative factor in
      filiform papillae atrophy. Studies have mentioned the role of zinc in wound healing and
      maintaining a healthy epithelium, as well as regeneration of filiform papillae. Geographic
      tongue is a disorder that affects the lingual papillae. It has been shown that zinc sulfate
      can contribute to the treatment of geographic tongue positively.
    

Detailed description: 
      Forty-eight patients diagnosed with symptomatic benign migratory glossitis will be selected
      from Oral Medicine, Periodontology and Oral Diagnosis department, Faculty of dentistry, Ain
      shams university. Research ethical committee will review the protocol and the procedure will
      be explained to the patients and they will sign an informed consent.

      Seven days after the diagnosis and selection of patients with (BMG), the atrophic areas will
      be determined and the patients will attend a control checkup in order to exclude those with
      constant changing patterns of the red atrophic areas with raised keratotic margins. Only
      those patients who presented with constant atrophic areas with keratotic margins at the
      control checkup will be included during the study evaluation process, then the selected
      patient according the following inclusion and exclusion criteria will be randomly allocated
      into two groups. Patients met the eligibility criteria will be randomly assigned for 2
      different groups using computer generated allocation concealment. Group I: Will include 24
      patients with symptomatic BMG receiving Zinc Supplementation once daily and zinc rich diet
      for one month. (study group).Group II: Will include 24 patients with symptomatic BMG
      receiving zinc rich diet only For one month. (control group). Intensity of the discomfort
      will be monitored by the patients using the Visual Analogue Scale (VAS). Saliva will be
      collected from all included patients to evaluate zinc levels before treatment and one month
      after treatment only.
    

Intervention name(s): Zinc Sulfate 110 MG (Zinc 25 MG) Oral Tablet
Intervention type(s): Drug
Intervention description(s): Zinc sulfate is an inorganic compound. It is used as a dietary supplement to treat zinc deficiency and to prevent the condition in those at high risk
Other intervention name(s): Octozinc
Intervention MeSH terms: Zinc Sulfate
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Benign Migratory Glossitis; Zinc; Geographic tongue
Compound Sodium Alginate Oral Suspension Sachet Symptomatic Relief Study
Condition: Gastro-esophageal Reflux Disease (GERD)
MeSH terms: Gastroesophageal Reflux
Study type: Interventional
Phase: Phase 3

Summary: 
      This study is being conducted in China to provide evidence for inclusion in applications to
      competent authorities that the Compound Sodium Alginate Oral Suspension sachet is effective
      in managing the symptoms of heartburn and acid regurgitation in patients with
      gastro-esophageal reflux disease (GERD).
    

Detailed description: 
      This is a multi-centre, randomised, double blind, two arm, parallel group, placebo-controlled
      clinical trial in patients with moderate to severe and frequent GERD symptoms. After signing
      a written informed consent, patients will undergo a screening period of up to 7 days.
      Patients who satisfy the study entry requirements within 7 days of consent, will be
      randomised to receive either Compound Sodium Alginate Oral Suspension sachets (20ml four
      times daily) or matching placebo sachets (20ml four times daily),for a 7- day treatment
      period. At the beginning and end of the treatment period, patients will be required to
      complete the Reflux Disease Questionnaire (RDQ).

      In addition, at the end of the 7 (-1 day to +2 days) day treatment period, patients will be
      required to complete the Overall Treatment Evaluation.
    

Intervention name(s): Compound Sodium Alginate Oral Suspension sachet; Matched placebo
Intervention type(s): Drug; Drug
Intervention description(s): Contents of 2 sachets taken four times daily for 7 days; Contents of 2 sachets taken four times daily for 7 days
Other intervention name(s): Gaviscon sachets; Placebo
Intervention MeSH terms: Alginate, aluminium hydroxide, magnesium trisilicate, sodium bicarbonate drug combination
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
A Trial to Evaluate the Effect of LEO 152020 on the Heart of Healthy People
Condition: Healthy Volunteers; Cardiac Repolarisation
Study type: Interventional
Phase: Phase 1

Summary: 
      The trial medicine (LEO 152020) is being developed to treat people with eczema.

      The aims of this trial are to find out about:

        -  How the trial medicine affects participant's heart rhythm.

        -  How much of the trial medicine is absorbed into the bloodstream, and how quickly the
           body gets rid of it.

        -  The safety of the trial medicine and any side effects that might be related to it.

      The trial will last up to 45 days, and there will be up to 6 visits.

      Four treatment periods are planned for this trial. In each treatment period, participant will
      receive a single dose of the trial medicine at dose A, trial medicine at dose B, dummy
      tablet, or an approved medication named moxifloxacin (used for the treatment of bacterial
      infections). The order of these 4 treatment periods is chosen at random. Participant will
      receive all 4 treatments; it is only the order of the treatments that is random.

      There will be 6 trial visits and they will include 1 screening visit, 4 treatment period
      visits and 1 final, follow-up visit at the clinic. The 4 treatment period visits will last
      for 3 days, from Day -1 (check-in to the clinic) to Day 2 (check-out of the clinic). There
      will be a period of at least 3 days between the 4 dosing occasions.
    


Intervention name(s): LEO 152020; Moxifloxacin; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Film-coated tablet
Route of administration: Orally
50 mg tablets; Tablet (may be film-coated depending on brand)
Route of administration: Orally
400 mg tablet; Film-coated tablet
Route of administration: Orally
No active ingredient
Intervention MeSH terms: Moxifloxacin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment