bioihbjkbjnl/mcl2 huggingface dataset:
Dysbiosis in Bipolar Disorder
Condition: Bipolar Disorder
MeSH terms: Dysbiosis; Bipolar Disorder
Study type: Observational

Summary: 
      The gut microbiota is a complex community comprising around 10^14 bacteria that live in the
      gut lumen. The imbalance of the normal structure and function of the microbiota, defined as
      dysbiosis, has been related to a wide diversity of pathologies, including mental health
      disorders. However, clinical evidence of the relationship between microbiota and mood
      disorders is lacking. The aim of this project is to examine the possible relationship of gut
      dysbiosis and the diagnosis of bipolar disorder (BD), of gut dysbiosis and mood relapses and
      of gut dysbiosis and cognitive impairment in bipolar patients.
    

Detailed description: 
      A prospective longitudinal study will be carried out with three groups of patients: a group
      of euthymic bipolar I or II patients without cognitive impairment (n=50), a second group of
      euthymic bipolar I or II patients with cognitive impairment (n=50) and a control group of
      healthy volunteers (n=50). Cognitive impairment will be defined as performance in any test of
      a domain below 2 standard deviations or more from the mean of normative data of each test
      assessed in the control group. Subjects will be recruited in the Hospital Clinic of
      Barcelona. At baseline clinical variables and diet patterns (ROME III) will be collected and
      neuropsychological performance (WCST, FAS, Stroop Colour-Word Interference test, TMT,
      WAIS-III, CVLT-II) and functionality (FAST) will be assessed. All subjects will be reassessed
      at 12 months follow-up. The mood state and possible affective relapses will be evaluated and
      treatments will be registered. All patients will receive standard psychiatric care according
      to international guidelines on bipolar disorders. Fecal samples will be collected and then
      frozen in the morning pre-prandial after having fasted overnight. DNA will be separated and
      stored at -80°C until assayed. Sequencing will be performed on an Illumina MiSeqTM platform.
      Statistical analysis will be performed with the latest existing version of the SPSS.
    

Intervention name(s): Genome sequencing of fecal samples
Intervention type(s): Other
Intervention description(s): Fecal samples will be collected and then frozen in the morning pre-prandial after having fasted overnight. DNA will be separated and stored at -80°C in our center (Biobanc) until assayed. Sequencing will be performed with the most appropriate platform.
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Subjects with BD will be recruited in the Bipolar Unit outpatient clinic in the Hospital
        Clinic of Barcelona. Healthy volunteers will be selected from the community.
      
Biospecimen description: 
      Stool sample
Ghrelin - A Possible Opportunity to Improve Appetite
Condition: Cancer
Study type: Interventional
Phase: Phase 3

Summary: 
      The study is designed to evaluate whether ghrelin treatment can improve appetite in weight
      losing cancer patients.
    

Detailed description: 
      Randomized study with follow up evaluations each month until preterminal state. Cancer
      patients will be randomised to either high dose or low dose of active treatment given as
      daily injection.
    

Intervention name(s): Ghrelin; Ghrelin
Intervention type(s): Drug; Drug
Intervention description(s): High dose of ghrelin given as subcutaneous injection once a day for the duration of 8 weeks.; Low dose of ghrelin given as subcutaneous injection once a day for the duration of 8 weeks.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Ghrelin; Nutrition; Cancer patients; Survival
Urdu Version of Menstrual Attitude Questionnaire: A Reliability and Validity Study
Condition: Menstruation
Study type: Observational

Summary: 
      To determine the validity and reliability of Urdu version of Menstrual Attitude Questionnaire
    

Detailed description: 
      Menstrual Attitude Questionnaire has been distributed in 200 women who were recruited by
      convenience sampling technique under the pre defined inclusion and exclusion criteria after
      signing the informed consent forms .

      This study's findings will assist determine the Menstrual Attitude Questionnaire's
      reliability and validity in individuals with neck pain and impairment. This scale's
      reliability will be evaluated utilising internal consistency and test-retest methods.
      Cronbach's alpha value checks internal consistency. The interclass correlation will be used
      to examine the test-retest reliability.
    

Observational model: Ecologic or Community
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Pregnant or Breastfeeding Women
      
Keywords: Attitude; Menstruation; females; psychometric properties; Menstrual Attitude Questionnaire
Evaluation of an Antihypertensive Food Supplement Based on Aqueous Extract From Annona Muricata Sheets
Condition: Hypertension
MeSH terms: Hypertension
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The AM-HTN trial aim to investigate the effects of a tablet based on aqueous extracts of
      Annona muricata as add-on therapy in a hypertensive population.

      Patients with prehypertension or stage 1 hypertension confirmed, will be selected and assign
      in a single arm, non randomly, open label clinical trial.

      The group will receive in addition to their dietary measures, daily, one tablet of 796 mg of
      aqueous extracts of Annona muricata leaves.

      The objective of AM-HTN is to determine the antihypertensive and metabolic effects of AM
      tablets in a population of African hypertensives.

      Blood pressure profile, lipid profile, serum creatinine and transaminases profiles will be
      recorded and analysed at baseline and two months following enrolment.
    

Detailed description: 
      The AM-HTN trial aim to investigate the effects of a tablet based on aqueous extracts of
      Annona muricata as add-on therapy in a hypertensive population.

      Patients with prehypertension or stage 1 hypertension confirmed, will be selected and assign
      in a single arm, non randomly, open label clinical trial.

      The group will receive in addition to their dietary measures, daily, one tablet of 796 mg of
      aqueous extracts of Annona muricata leaves.

      The objective of AM-HTN is to determine the antihypertensive and metabolic effects of AM
      tablets in a population of African hypertensives.

      Blood pressure profile, lipids profile, serum creatinine and transaminases profiles were will
      be recorded and analysed at baseline and two months following enrolment.
    

Intervention name(s): Annona muricata
Intervention type(s): Dietary Supplement
Intervention description(s): Patients with prehypertension or stage 1 hypertension, in dietary measures, will received daily one tablet of 796 mg of aqueous extracts of Annona muricata leaves. During 60 days
Intervention model: Single Group Assignment
Intervention model description: Before and after study intervention
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Annona muricata; Hypertension; Sub saharan Africa
An Exploratory Study of Naltrexone Plus Aripiprazole for Alcohol Dependence
Condition: Alcohol Dependence
MeSH terms: Alcoholism
Study type: Interventional
Phase: Phase 2

Summary: 
      The principal aim of this exploratory study is to examine whether the addition of
      aripiprazole to naltrexone will enhance efficacy over naltrexone alone in a 16-week
      randomized, placebo-controlled clinical trial, in which all subjects will be provided medical
      management as delivered in the COMBINE Study (Anton et al, 2006). To test whether medication
      treatment will reduce drinking compared to placebo treatment alone in the context of medical
      management and whether naltrexone plus aripiprazole will reduce drinking compared to
      naltrexone treatment alone in the context of medical management.
    


Intervention name(s): Placebo; Naltrexone; Naltrexone + Aripiprazole
Intervention type(s): Drug; Drug; Drug
Intervention description(s): placebo; Naltrexone (25mg or 50 mg per titration schedule); Naltrexone + Aripiprazole (5mg - 15mg per titration schedule)
Intervention MeSH terms: Naltrexone; Aripiprazole
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Alcohol Dependence; Alcoholism; Naltrexone; Aripiprazole; Substance Abuse
Optimizing the Effectiveness of Selective Serotonin Reuptake Inhibitors (SSRIs) in Treatment-Resistant Depression
Condition: Depression
MeSH terms: Depression; Depressive Disorder; Depressive Disorder, Treatment-Resistant
Study type: Interventional
Phase: Phase 2

Summary: 
      This study will determine the effectiveness of adding S-adenosyl methionine to antidepressant
      drug treatment in reducing depressive symptoms in depressed people who have not responded to
      antidepressants alone.
    

Detailed description: 
      Some people with depression do not respond well to antidepressant treatment. S-adenosyl
      methionine (SAMe) is a naturally occurring compound that may have antidepressant effects.
      SAMe may also enhance the effectiveness of other antidepressants, such as selective serotonin
      reuptake inhibitors (SSRIs). This study will determine the effectiveness of oral SAMe in
      enhancing the effects of SSRIs in patients currently not responding to SSRI treatment.

      This study will last 6 weeks. No follow-up visits will occur. Participants will be randomly
      assigned to add either oral SAMe or placebo to their existing SSRI regimen for 6 weeks.
      Depression scales and self-report questionnaires regarding depressive symptoms will be used
      to assess participants at the end of the study.
    

Intervention name(s): S-adenosyl methione (SAMe); Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Oral SAMe tosylate, up to 1600 mg per day for 6 weeks; Placebo to be taken daily for 6 weeks
Other intervention name(s): Oral SAMe tosylate; Pill identical in appearance to drug but placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Selective Serotonin Reuptake Inhibitors; S-adenosyl Methionine; SSRI; SAMe
Clinical Effects of Exercise Program Added to Pulmonary Rehabilitation in Patients With Cystic Fibrosis
Condition: Cystic Fibrosis
MeSH terms: Cystic Fibrosis; Fibrosis
Study type: Interventional

Summary: 
      The aim of this study is to investigate the effects of postural exercise program added to
      pulmonary rehabilitation program on quality of life, exercise tolerance and postural
      stability in children with Cystic Fibrosis.
    

Detailed description: 
      Cystic fibrosis (CF) is an autosomal recessive, multisystem involvement disease. The most
      important cause of mortality in CF is pulmonary complications. Prevention of pulmonary
      complications is only possible with pulmonary rehabilitation. Pulmonary rehabilitation
      methods used in CF are called airway cleaning techniques that include postural drainage,
      breathing techniques and use of devices. These techniques have not been proven to be superior
      to each other. Active cycle of breathing techniques (ACBT) is one of the breathing techniques
      used to remove secretions from the lungs.

      Pulmonary disease progression in CF causes postural impairment and decrease of exercise
      tolerance, which can reduce effectiveness of pulmonary rehabilitation. The aim of this study
      is to investigate the effects of postural exercise program added to pulmonary rehabilitation
      program on quality of life, exercise tolerance and postural stability in children with CF.
    

Intervention name(s): Active cycle of breathing techniques (ACBT); Postural Exercise
Intervention type(s): Other; Other
Intervention description(s): ACBT involves three phases (Breathing control, chest expansion exercise, and huff coughing). These phases will apply with a sequence to remove secretion. ACBT will apply 1 per a week for 6 weeks.; Postural exercise program will include thoracic vertebra mobilization, pectoral stretching, scapula and thoracic extensors strengthening and core stability exercises. Postural exercise program will apply 1 per a week for 6 weeks.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Cystic Fibrosis; Postural exercise; Pulmonary rehabilitation
Hepatectomy With or Without Transcatheter Arterial Chemoembolization for Stage IIIA Hepatocellular Carcinoma
Condition: Hepatocellular Carcinoma; Hepatectomy; Chemoembolization
MeSH terms: Carcinoma; Carcinoma, Hepatocellular
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate whether hepatectomy combining with adjuvant
      transcatheter arterial chemoembolization (TACE) for Stage IIIA hepatocellular carcinoma (HCC)
      resulting better long-term survival outcome when compared with hepatectomy alone.
    

Detailed description: 
      Hepatocellular carcinoma (HCC) is one of the most common malignancies in the world, and the
      prevalence is increasing in the United States. Hepatectomy is still considered as the
      potentially curative treatment for HCC. Unfortunately, long-term survival after hepatectomy
      is still unsatisfactory because of the high incidence of tumor recurrence, especially
      intrahepatic recurrence.

      Stage IIIA hepatocellular carcinoma (HCC) include multiple tumors more than 5 cm or tumor
      involving a major branch of the portal or hepatic vein(s) in the International Union Against
      Cancer (UICC) TNM staging for liver tumors, sixth edition 2002. Until now there are
      controversies in the management of Stage IIIA HCC. According to the Barcelona
      -Clinic-Liver-Cancer (BCLC) proposal, Stage IIIA HCC represented as intermediate or advanced
      disease. The European Association for Study of the Liver (EASL) and the American Association
      for the Study of Liver Diseases (AASLD) recommended randomized controlled trials of
      chemoembolization or new agents for such stage of disease. Whereas in Asian areas, such as
      China or Japan, partial hepatectomy or reductive surgery (with or without adjuvant therapy)
      was performed for multiple advanced HCC or tumor with a major branch of the portal or hepatic
      vein(s) invasion, although no prospective study to assess the therapeutic efficacy and
      safety. On the other hand, transcatheter arterial chemoembolization (TACE) is the most widely
      used primary treatment for unresectable HCC. It was also used as the optional treatment of
      relapsed disease. However, the efficacy of TACE used as adjuvant therapy following
      hepatectomy remains controversial. Neither are there large randomized controlled trials to
      address this field. Therefore, a randomized controlled trial was performed in our cancer
      center to compare hepatectomy with adjuvant TACE and hepatectomy alone for the Stage IIIA
      HCC.
    

Intervention name(s): hepatectomy and transcatheter arterial chemoembolization; hepatectomy
Intervention type(s): Procedure; Procedure
Intervention description(s): partial hepatectomy with adjuvant transcatheter arterial chemoembolization; hepatectomy alone
Other intervention name(s): hepatectomy alone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: hepatocellular carcinoma; hepatectomy; chemoembolization; randomized controlled trial; prognosis
The Effect of Urinating Through the Zipper or by Pulling Down the Trousers on Uroflowmetry Parameters in LUTS
Condition: Benign Prostatic Hyperplasia; Micturition Disorder; Urinary Obstruction; Urinary Tract Disease; Urologic Diseases
MeSH terms: Prostatic Hyperplasia; Urologic Diseases; Urination Disorders; Hyperplasia
Study type: Observational

Summary: 
      There are many factors that affect uroflowmetry parameters. One of these is the urination
      position. Research has mostly focused on standing and sitting urination positions. However,
      those who prefer the standing position as a habit can urinate by opening the zipper or
      lowering the trousers. Although the effect of these two applications on uroflowmetry
      parameters in healthy men has been investigated in only one study, their effect on patients
      with lower urinary tract symptoms has not been examined.
    


Intervention name(s): position of urination
Intervention type(s): Diagnostic Test
Intervention description(s): effect of position on uroflowmetry parameters
Observational model: Other
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients on alpha blocker therapy with LUTS due to BPO
      
Keywords: benign prostatic obstruction; uroflowmetry; urodynamics
Study of CA-008 (Vocacapsaicin) in Total Knee Arthroplasty
Condition: Postsurgical Pain
MeSH terms: Pain, Postoperative
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a two-part, Phase 2, multi-center, randomized, double-blind, placebo-controlled,
      parallel design study of CA-008 (vocacapsaicin) vs. placebo injected/instilled during an
      elective TKA.
    

Detailed description: 
      This is a Phase 2, multi-center, randomized, double-blind, placebo-controlled, parallel
      design study evaluating, in a pilot stage of the study, up to 3 ascending dose level cohorts
      each evaluating a single dose of CA-008 vs. placebo injected/instilled during an elective
      TKA. Up to 54 subjects will be randomized in the pilot stage. During the optional second
      stage of the study, subjects will be randomized to one of either 2 or 3 CA-008 dose levels
      (to be determined) or placebo. The Sponsor made the decision not to proceed with the second
      stage.
    

Intervention name(s): CA-008; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 5 mg CA-008 (0.05 mg/mL), 10 mg CA-008 (0.1 mg/mL) and 15 mg CA-008 (0.15 mg/mL); Placebo
Other intervention name(s): vocacapsaicin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
A Study to Compare Efficacy and Safety of CT-P17 With Humira in Patients With Active Rheumatoid Arthritis
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a Phase III Study to Compare Efficacy and Safety of CT-P17 with Humira in Patients
      With Active Rheumatoid Arthritis
    

Detailed description: 
      CT-P17, containing the active ingredient adalimumab, is a recombinant humanized monoclonal
      antibody that is being developed as a similar biological medicinal product to Humira. The
      purpose of this study is to demonstrate similar efficacy and safety of CT-P17 and Humira in
      patients with moderate to severe rheumatoid arthritis when co-administered with methotrexate.
    

Intervention name(s): CT-P17 SC; Humira SC
Intervention type(s): Biological; Biological
Intervention description(s): Subcutaneous injection of Adalimumab 40mg every two weeks; Subcutaneous injection of Adalimumab 40mg every two weeks
Intervention MeSH terms: Adalimumab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Performance Study of the Invendo C20 Colonoscope System in Colorectal Cancer Screening
Condition: Colorectal Cancer Screening
MeSH terms: Colorectal Neoplasms
Study type: Observational

Summary: 
      The purpose of the study is to evaluate efficacy (i.e. reaching the cecum) and safety of the
      Invendo C20 Colonoscopy System
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Asymptomatic persons fulfilling U.S. screening criteria for colorectal cancer of age of
        50-75 years
A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of C16TR for Inhalation With Tyvaso® Cohort in Healthy Participants
Condition: Healthy Volunteers
MeSH terms: Respiratory Aspiration
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary purpose of this study is to determine the safety and tolerability of escalating
      doses of C16TR for inhalation in healthy participants.
    


Intervention name(s): C16TR; Placebo; Tyvaso®
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Administered as inhalation using a Philips Micro device inhaler.; Phosphate buffered saline (PBS) administered using Philips Micro device inhaler.; Administered as inhalation.
Other intervention name(s): Hexadecyl-treprostinil; Inhaled treprostinil
Intervention MeSH terms: Treprostinil
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Effect of Rasagiline on BIA 9-1067 Pharmacokinetics
Condition: Parkinson Disease
MeSH terms: Parkinson Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to investigate the effect of rasagiline on BIA 9-1067
      pharmacokinetics in healthy subjects.
    

Detailed description: 
      Single-centre, open-label, randomised, three-way crossover study consisting of 3 single-dose
      periods separated by a washout of 14 days or more
    

Intervention name(s): BIA 9-1067; Rasagiline
Intervention type(s): Drug; Drug
Intervention description(s): 50 mg BIA 9-1067 (single-dose); 1 mg rasagiline (single-dose)
Other intervention name(s): OPC, Opicapone; Azilect®
Intervention MeSH terms: Opicapone; Rasagiline
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Parkinson Disease; BIA 9-1067
Exenatide Compared With Twice-Daily Biphasic Insulin Aspart in Patients With Type 2 Diabetes Using Sulfonylurea and Metformin
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a Phase 3, multicenter, open-label, comparator-controlled trial comparing the effect
      of exenatide twice daily to twice daily biphasic insulin aspart on glycemic control, as
      measured by hemoglobin A1c (HbA1c).
    


Intervention name(s): exenatide; biphasic insulin aspart
Intervention type(s): Drug; Drug
Intervention description(s): subcutaneous injection, twice daily; 5 mcg for 4 weeks followed by 10 mcg for 48 weeks; subcutaneous injection, twice daily; titration to target blood glucose level
Other intervention name(s): Byetta; NovoLog
Intervention MeSH terms: Insulin Aspart; Exenatide; Biphasic Insulins
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: diabetes; exendin; Amylin; Lilly; insulin aspart