bioihbjkbjnl/mcl2 huggingface dataset:
Phase 1 Study of ELX-02 in Healthy Adult Subjects
Condition: Genetic Disease; Nonsense Mutation
MeSH terms: Genetic Diseases, Inborn
Study type: Interventional
Phase: Phase 1

Summary: 
      Phase 1 Multiple Ascending Dose Study in Normal Healthy Volunteers
    

Detailed description: 
      This is a study in humans of ELX-02, an advanced synthetic aminoglycoside optimized as a
      translational read-through drug (TRID) for the treatment of genetic conditions caused by
      nonsense mutations. This is a classical Phase 1b study designed as a randomized,
      double-blinded, placebo-controlled, multiple dose escalation to evaluate the safety,
      tolerability, and pharmacokinetics of ELX-02 in healthy adult volunteers.
    

Intervention name(s): ELX-02; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): ELX-02 is a synthetic, designer eukaryotic ribosomal specific glycoside (ERSG) optimized as a translational read-through drug; Placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Cohort 1: ELX-02 0.1 mg/kg or placebo SC twice a week for 9 doses;
Cohort 2: ELX-02 0.3 mg/kg or placebo SC twice a week for 9 doses;
Cohort 3: ELX-02 1.0 mg/kg or placebo SC twice a week for 9 doses;
Cohort 4: ELX-02 2.5 mg/kg or placebo SC twice a week for 9 doses;
Cohort 5: ELX-02 up to 2.5 mg/kg (50 mg/mL per injection) or placebo SC twice a week for 9 doses;
Cohort 6: ELX-02 2.5 to 5.0 mg/kg or placebo SC twice a week for 9 doses. Optional Cohort
Cohort 7: ELX-02 up to 5.0 mg/kg or placebo SC twice a week for 9 doses. Optional Cohort
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Translational read through
Curcumin Supplementation and Patients With Type 2 Diabetes
Condition: Non Insulin Dependent Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      Diabetes mellitus is the most common endocrine disorder, causes many complications such as
      micro- and macro-vascular diseases. Various kinds of antidiabetic drugs have been developed,
      but most of them have side effects. Recently, the use of natural plant products has gained
      more attention among scientists in order to prevent diabetic vascular complications. Curcumin
      is a natural yellow product derived from the turmeric rhizome which has shown to be non-toxic
      and exhibits various bio¬logical activities such as anti-oxidant, anti-inflammatory,
      anti-carcinogenic, and anti-diabetic effects. Curcumin is effective in reducing glycemic
      index and hyperlipidemia in rodent models and is relatively inexpensive and safe. Most of the
      studies conducted on animal model, and just a few of them are on human model. The present
      study was planned to evaluate the effects of curcumin supplementation The effect of curcumin
      supplementation on anthropometric indices, insulin resistance and oxidative stress in
      patients with type 2 diabetes
    


Intervention name(s): Curcumin; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention MeSH terms: Curcumin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Measuring Menstrual Iron Loss Using the Iron Isotope Dilution Technique
Condition: Iron-deficiency; Menorrhagia; Anemia
MeSH terms: Menorrhagia; Iron Deficiencies
Study type: Observational

Summary: 
      It is very difficult to quantify menstrual blood loss, the reference method is a tedious one.
      This is a problem, as it is not conducive to objectively measuring menstrual blood loss and
      understanding the contribution of menstrual iron loss to iron deficiency anemia. With this
      study, the investigators aim to investigate iron loss during the menstrual cycle and aim to
      validate a much simpler technique.
    

Detailed description: 
      Anemia reduction efforts have largely focused on increasing iron intakes such as improving
      diet quality, food fortification with iron, iron supplementation, biofortification. There is
      little information on the contribution of menstrual iron loss to iron deficiency anemia.

      Indeed, the accurate measurement of menstrual blood loss volume and iron loss is difficult.
      Self-perception of heavy menstrual blood loss poorly predicts actual blood loss, and the
      objective measurement of menstrual blood loss remains a tedious method. Various methods have
      been used to objectively measure menstrual blood loss volume including radioisotopes, but
      these methods are invasive. The investigators aim to validate a much simpler technique,
      namely the stable iron isotope dilution methodology. This is a promising new method for
      quantifying long-term body iron balance, absorption, and loss which has not been applied
      previously to measure menstrual iron losses. Validating this new method against the alkaline
      hematin reference method would be an important step to encourage menstrual blood loss
      measurements and shed light on the contribution of menstrual blood loss to iron deficiency
      and iron deficiency anemia.
    

Intervention name(s): Iron isotope dilution; Alkaline hematin method
Intervention type(s): Other; Other
Intervention description(s): Menstrual blood loss will be determined using the iron isotope dilution technique and compared to the amount determined via the alkaline hematin method.; Menstrual blood loss will be determined using the alkaline hematin method and compared to the amount determined via the iron isotope dilution technique.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Female 18-30 year olds, who have already been labelled with stable iron isotopes.
      
Biospecimen description: 
      Blood samples will be collected for the measurement of hemoglobin, iron status and iron
      isotope dilution, as well as menstrual iron loss.
    
Keywords: anemia; menstruation; alkaline hematin; iron isotope dilution; blood loss; menorrhagia
The Nash-wo-Numa (Childhood Growth & Development) Study
Condition: Adolescent Development; Stunting; Depression; Micronutrient Deficiency
MeSH terms: Growth Disorders
Study type: Observational

Summary: 
      The proposed study will be a cross-sectional study in the District of Matiari, Pakistan.
      Children ages 9-15 years will be identified from a Matiari District household census
      scheduled being conducted from December 2016- to May 2017 by the Department of Pediatrics and
      Child Health, Aga Khan University. Anthropometric measures, Tanner Stage, Hemoglobin
      concentration, blood draw as well as questionnaires will be assessed in all participants.
    


Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        The study will be conducted in Matiari District in the Province of Sindh, Pakistan. The
        population of Matiari (2017) was estimated to be 769,349 with approximately 85% being
        rural. There are approximately 48,000 school-aged children between 9.0 and 15.9 years of
        age living in the District, which is representative of rural conditions in Pakistan.
      
Biospecimen description: 
      As described in the protocol. Blood specimen will be stored for future analysis of few
      assays, based on funding.
GOLimumab and Methotrexate Versus Methotrexate in Very Early PsA (GOLMEPsA)
Condition: Psoriatic Arthritis
MeSH terms: Arthritis, Psoriatic
Study type: Interventional
Phase: Phase 3

Summary: 
      An investigator-initiated double-blind, parallel-group randomised controlled trial of
      GOLimumab and Methotrexate versus Methotrexate in very early PsA using clinical and whole
      body MRI outcomes.
    

Detailed description: 
      Phase IIIb. Early Psoriatic Arthritis. Investigator initiated, double-blind, randomized,
      placebo-controlled, two-armed, parallel-group, single centre trial.

      The Primary Objective is to assess whether the combination of golimumab with methotrexate and
      steroids is superior to standard care (MTX monotherapy plus steroids) in reducing clinical
      disease activity in patients with early, treatment naïve PsA.
    

Intervention name(s): Golimumab; Methotrexate
Intervention type(s): Drug; Drug
Intervention description(s): Simponi; Methotrexate
Intervention MeSH terms: Golimumab; Methotrexate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Gut Microbiota in Obesity and Diabetes
Condition: Obesity; Type 2 Diabetes Mellitus
MeSH terms: Obesity; Diabetes Mellitus, Type 2
Study type: Observational

Summary: 
      An altered gut microbiota composition has recently been linked to obesity and diabetes. The
      principal aim of this study was to investigate and compare the gut microbiota composition of
      obese, diabetic and control individuals. Then, associations between analyzed gut microbial
      concentrations and clinical-biochemical blood parameters were assessed.
    


Intervention name(s): Comparison of the gut microbiota composition
Intervention type(s): Other
Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Tertiary referral center
      
Keywords: Gut microbiota
Study to Evaluate Safety, Tolerability, and Pharmacokinetics of Minocin (Minocycline) for Injection in Healthy Adults
Condition: Normal Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      This was a Phase 1, randomized, double-blind, placebo-controlled, single and multiple
      ascending dose study of the safety, tolerability, and pharmacokinetics of Minocin
      (minocycline) for injection in healthy adult participants.
    

Detailed description: 
      The purpose of this study was to collect safety, tolerability, and pharmacokinetic (PK) data
      on ascending dose regimens of Minocin (minocycline) for Injection. The safety, tolerability,
      and PK data was to support the compound as a potential clinical candidate in Europe and allow
      recommendations of dose levels to be used in future Phase 2/3 studies.
    

Intervention name(s): Minocin (minocycline) for Injection; Placebo
Intervention type(s): Drug; Other
Intervention description(s): Intravenous formulation of minocycline, a derivative of tetracycline; Placebo - Normal Saline
Other intervention name(s): Minocin; Minocycline
Intervention MeSH terms: Minocycline
Allocation: Randomized
Intervention model: Sequential Assignment
Intervention model description: Model Description: Cohorts 1 and 2 were run concurrently as they were using the approved doses of intravenous minocycline in the United States. Cohorts 3, 4, 5 and 6 were run sequentially and only after review of data from the preceding cohorts by the data monitoring committee.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Bacterial infections
Open Label Study to Assess the Effect of Patient Use and Robustness of Tiotropium 18ug Inhalation Powder, Hard Capsule,Zephir Inhaler Device
Condition: COPD
MeSH terms: Respiratory Aspiration
Study type: Interventional
Phase: Phase 1

Summary: 
      An Open Label Study to Assess the Effect of Patient Use and Robustness of Tiotropium 18ug
      Inhalation Powder, Hard Capsule, Inhaler Device. Zephir inhaler robustness will be assessed
      by in vitro testing of the Zephir inhaler after 12 weeks of patient use
    


Intervention name(s): Tiotropium 18 µg inhalation powder, hard capsule; Zephir inhaler
Intervention type(s): Drug; Device
Intervention description(s): Tiotropium 18 µg administered using Zephir inhaler; Tiotropium 18 µg administered using Zephir inhaler
Intervention MeSH terms: Tiotropium Bromide
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Case Series With Saneso 3600 Colonoscope
Condition: Colonic Neoplasms
MeSH terms: Colonic Neoplasms
Study type: Interventional

Summary: 
      Saneso colonoscope is a novel FDA cleared colonoscope that provides a 360 degree integrated
      view of the colon. Saneso colonoscope has five cameras and multiple LED lights at the distal
      head. The objective of the present study is to evaluate clinical success of the Saneso
      colonoscope in intubation of the terminal ileum and to obtain user feedback with regards to
      usability characteristics compared to predicate devices.
    

Detailed description: 
      This study is a prospective, multi-center case series of per standard of care colonoscopy
      procedures using a nonsignificant risk Saneso 360 degree colonoscope. 40 cases were included
      at 3 clinical sites. Patients who meet all eligibility criteria were included and had a
      clinically indicated colonoscopy procedure performed using the study device. Immediately
      thereafter, patients had a colonoscopy procedure using standard colonoscope (Olympus CF 180)
      by a second endoscopist. Enrolled subjects were followed for 7 days after their procedure. If
      the procedure was not successful with the study device, the endoscopist completed the
      procedure with a traditional colonoscope used at each facility. This study was approved by
      the institutional review board of respective sites. The clinical trial was conducted in
      accordance with the standards of Good Clinical Practice (GCP) and in accordance with the
      principles of the Declaration of Helsinki.
    

Intervention name(s): Colonoscopy
Intervention type(s): Device
Intervention description(s): Patients who meet all eligibility criteria were included and had a clinically indicated colonoscopy procedure performed using the study device. Immediately thereafter, patients had a colonoscopy procedure using standard colonoscope (Olympus CF 180) by a second endoscopist.
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Intervention model description: The objective of the present study is to Study the clinical success and clinical safety of the Saneso colonoscope
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Colonoscopy; Colonoscope
Triplet (FOLFOXIRI) vs. Doublet (FOLFOX or FOLFIRI) Regimen as a 1st Line Treatment in Metastatic Colorectal Carcinoma
Condition: Metastatic Colorectal Cancer
MeSH terms: Colorectal Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a prospective randomized phase II trial was done in clinical oncology department at
      Kasr Alainy hospital, Cairo university (NEMROCK) to evaluate the role of intensification of
      chemotherapy in the first line for treatment of metastatic colorectal carcinoma by adding
      third agent to standard doublet regimen on oncological outcomes & assess tolerance to the
      intensified treatment
    

Detailed description: 
      Patients with histologically proven adenocarcinoma of the colon or rectum, with unresectable
      measurable metastatic disease, were enrolled and randomized in a 1:1 ratio.

      Patients were assigned to receive FOLFOXIRI (experimental arm) or FOLFIRI or FOLFOX4 (control
      arm) biweekly up to 12 cycles.

      Randomization was done by enclosed envelope method Evaluation of the patients for surgical
      resection of residual metastases was done every 12 weeks. In the case of secondary resection
      of metastases, patients completed with the same chemotherapy regimen received before
      resection up to 12 cycles Maintenance therapy with capecitabine for 6 months was administered
      for patients who achieved complete or partial tumor response. In case of disease progression,
      second line chemotherapy was then administered in both groups until tumor progression, the
      occurrence of an unacceptable adverse event, or patient refusal
    

Intervention name(s): FOLFOXIRI Protocol
Intervention type(s): Drug
Intervention description(s): Triplet chemotherapy regimen consists from active three cytotoxic agents aiming to improve outcomes
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: First line chemotherapy; FOLFOXIRI; standard doublet; Efficacy; Toxicity
Reliability of BIS Monitoring in Neurosurgical Patients
Condition: Sovra and Intra Tentorial Lesions
Study type: Observational

Summary: 
      The aim of the study is to assess the reliability of Bispectral Index (BIS Vista , Covidien)
      in neurosurgical patients . BIS values at Loss of Consciousness (LOC), Post Intubation (PI)
      and Return of Consciousness (ROC) in neurosurgical patients are compared to those of
      non-neurosurgical patients, during routine anesthesia procedures.
    


Intervention name(s): Bispectral Index (BIS Vista, Covidien)
Intervention type(s): Device
Intervention description(s): BIS values at LOC, PI, ROC.
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        patients undergoing elective craniotomy and elective spinal cord and column surgery.
An Investigation Of The Effects Of Food On The Absorption Of A Varenicline Controlled Release Formulation
Condition: Pharmacokinetics; Bioavailability; Smoking Cessation
Study type: Interventional
Phase: Phase 1

Summary: 
      1. To estimate the absorption of a single oral dose of a controlled release varenicline
           tablet under fed and fasted conditions.

        2. To evaluate the pharmacokinetics, safety, and tolerability of a single dose of a
           varenicline controlled release tablet under fed and fasted conditions.
    


Intervention name(s): Varenicline Tartrate Controlled Release; Varenicline Tartrate Controlled Release
Intervention type(s): Drug; Drug
Intervention description(s): A single, 2.4 mg dose of a varenicline controlled release tablet administered orally under fasted conditions; A single, 2.4 mg dose of a varenicline controlled release tablet administered orally under fed conditions
Intervention MeSH terms: Varenicline
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Keywords: food, varenicline, pharmacokinetics, bioavailability
Content-free Speech Analysis for Measurement of Mental Health
Condition: Mental Disorder; Conditions Influencing Health Status
MeSH terms: Mental Disorders; Psychotic Disorders
Study type: Interventional

Summary: 
      Trial to prove the functionality and efficacy of a content-free speech analysis tool to
      detect problematic mental health status or phases of patients with pre known or unknown
      mental health disorders, focussed on affective disorders or neurodevelopmental disorders. The
      participants talk in free speech to the tool, this will be analyzed content-free and compared
      with psychological instruments to detect the mental status in conventional way.
    

Detailed description: 
      Participants with and without pre known mental disorders will be recruited and analyzed with
      speech analysis and conventional psychological instruments, as primary measurement the
      SCL-90-Scale, as secondary instruments the PRIME-MD (explicit in use the PHQ-9 for depressive
      symptoms and the GAD-7 for anxiety), B5T and an ADHD-VAS-Score (t0). Then the investigators
      check the status of the participants later at t1 (4-6 weeks after t0) and t2 (4-6 weeks after
      t1).

      The speech measuring instruments is the "VoiceSense" digital voice analysis tool, which
      enables the analysis of 200 specific speech parameters and the assessment of the findings
      through the use of psychometric instruments and questionnaires.

      The hypothesis is that the data of the voicesense analysis tool compared to the psychological
      instruments provide a good match and the voicesense technique can be used as a predictive and
      course-description tool in mental illness.
    

Intervention name(s): Speech analysis tool; Conventional psychological measurements
Intervention type(s): Diagnostic Test; Diagnostic Test
Intervention description(s): Using the speech analysis tool with recording 120 seconds of free speech and analysis of 200 content-free parameters of the speech including factor analytic process to compress the data to 5-10 core parameters.; Using well known and validated psychological measurements to identify the mental state of the participants.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Two randomized groups of participants, blinded to rater in relation of the diagnosis of the individual proband.
Masking: Single (Outcomes Assessor)
Primary purpose: Diagnostic
Keywords: Mental Disorder; Treatment planning; Technical measurements of mental state; Course-prediction of Mental Illness
S-1 and Radiotherapy in Elderly Patients With Esophageal Cancer
Condition: Esophageal Cancer
MeSH terms: Esophageal Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      Elderly patients with esophageal cancer will receive thoracic radiation therapy 54Gy over 30
      fractions, and concurrent with s-1 on days 1-14 and 29-42 at the following dosages: 60, 70,
      and 80 mg/m(2)/day.
    

Detailed description: 
      Purpose:evaluated the dose-limiting toxicity and recommended dose of S-1 for a future phase
      II study when administered concurrently with thoracic radiation in elderly patients (>70
      years old) with esophageal Cancer.

      Methods:S-1 was administered on days 1-14 and 29-42 at the following dosages: 60, 70, and
      80mg/m(2)/day. Thoracic radiation therapy was administered in 1.8Gy fractions five times
      weekly to a total dose of 54 Gy.
    

Intervention name(s): S-1
Intervention type(s): Drug
Intervention description(s): S-1 was administered on days 1-14 and 29-42 at the following dosages: 60, 70, and 80mg/m(2)/day
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: S-1; radiation; esophageal Cancer