bioihbjkbjnl/mcl2 huggingface dataset:
T-cell Based Immunotherapy for of Melanoma
Condition: Melanoma
MeSH terms: Melanoma
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The aim of this study is to investigate the toxicity and clinical response of therapy with
      tumor infiltrating lymphocytes as treatment for advanced melanoma.

      Patient will receive a single treatment consisting of conditioning chemotherapy for seven
      days (cyclophosphamide for two days and fludarabine for five days), intravenous infusion of
      high number of in vitro expanded tumor infiltrating lymphocytes followed by two weeks with
      daily low-dose interleukine-2. Patients will be evaluated for toxicity, tumor response, and
      immune response.

      After the first 6 patients the treatment with IL-2 has been changed to include higher doses
      of IL-2 (see intervention)
    


Intervention name(s): cyclophosphamide, fludarabine, T-cells, Interleukin-2
Intervention type(s): Biological
Intervention description(s): Two days of cyclophosphamide (60 mg/kg i.v.) and five days of fludarabine (25 mg/m2 i.v.). Infusion of Tumor Infiltrating Lymphocytes (10e9-10e10 cells). Followed by daily sc injections of 2 MIE Interleukin-2 for two weeks. After the first 6 patients the dose of IL-2 has been changed to an i.v. decrescendo regimen using 18 MIU/m2 infused over 6, 12 and 24 hours and then 4.5 MIU/m2 infused over 24 hours for three days.
Other intervention name(s): Cyclophosphamide, Sendoxan®, Baxter A/S; Fludarabine, Fludara®, Bayer Shering; Interleukin-2, Proleukin®, Chiron B.V.
Intervention MeSH terms: Cyclophosphamide; Fludarabine; Fludarabine phosphate; Interleukin-2
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Tuberculosis (TB) Immunotherapy Phase 2 Study
Condition: Tuberculosis
MeSH terms: Tuberculosis
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a phase II, randomized, placebo-controlled trial, aimed to seek the therapeutic
      benefit of V7 in combination with standard of care anti-Tuberculosis (TB) therapy (ATT) among
      Mycobacterium tuberculosis-infected sputum smear positive subjects. The results will be
      compared to placebo combined with standard ATT therapy. The trial will consist of one stage
      with sputum evaluation at months 1 and 2.
    


Intervention name(s): V7; placebo
Intervention type(s): Biological; Other
Intervention description(s): experimental arm; placebo pill
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: sputum conversion; liver biochemistry; weight loss; quality of life
FB101 Intervention in Women Screened to Have Vaginal Dysbiosis
Condition: Vaginal Flora Imbalance
Study type: Interventional

Summary: 
      This study will explore and map the potential shifts in vaginal microbiomes as a consequence
      of a microbial intervention with product FB101 in healthy, asymptomatic volunteer women
      screened to have vaginal dysbiosis based on criteria defined by metagenomic sequencing of a
      vaginal swab sample.
    

Detailed description: 
      This study will explore and map the potential shifts in vaginal microbiomes as a consequence
      of a microbial intervention with product FB101 in healthy, asymptomatic volunteer women
      screened to have vaginal dysbiosis based on criteria defined by metagenomic sequencing of a
      vaginal swab sample. A dose of FB101 will be given on 3 different days and subjects will be
      followed for changes in their vaginal microbiomes until approximately 6 months after the
      first FD101 dose.

      The study includes a screening visit where all criteria for participation are checked and a
      vaginal swab is obtained to check if pre-defined dysbiosis criteria are met based on
      metagenomic sequencing. If, and when, all criteria are confirmed, a baseline visit, visit 2,
      is scheduled to be performed around day 8 of the following menstrual cycle of each individual
      subject. Besides baseline assessments, the subject is randomised to active FB101 or placebo
      in a ratio of 3(active): 1(placebo) and the first dose is given. At visit 3 and 4 (performed
      on day 9 and 10 in the same menstrual cycle as Visit 2) the following 2 doses are given.

      In total, 7 follow-up visits (visit 5-11) are scheduled to occur for a period of up to 6
      months after the first dose. All follow-up visits will be scheduled to occur around day 8 in
      the subject's menstrual cycle with one menstrual cycle in between visits. At follow up
      visits, close safety monitoring will be performed as well as metagenomic sequencing
      assessment of the microbiota in a vaginal swab.
    

Intervention name(s): FB101; Placebo
Intervention type(s): Other; Other
Intervention description(s): Microbial intervention using product FB101; Saline water
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomised, double-blind, parallel, 2-arm, placebo-controlled study.
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
To Demonstrate the Relative Bioequivalency Comparing Geneva's 10 mg Glipizide Tablets To Roerig's 10 mg Glucotrol Tablets
Condition: Type 2 Diabetes
Study type: Interventional
Phase: Phase 1

Summary: 
      To demonstrate the relative bioequivalency comparing Geneva's 10 mg Glipizide tablets to
      Roerig's 10 mg Glucotrol tablets.
    


Intervention name(s): Glipizide 10 mg Tablets (Geneva Pharmaceutical, Inc.); Glucotrol 10 mg Tablets (Roerig Pharmaceutical, Inc.)
Intervention type(s): Drug; Drug
Intervention MeSH terms: Glipizide
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Immunogenicity Study of Recombinant Human Papillomavirus Vaccine(6,11,16,18,31,33,45,52,58 Type)(E.Coli)
Condition: Condylomata Acuminata; Cervical Cancer
MeSH terms: Uterine Cervical Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      This phase II clinical study was designed to evaluate the immunogenicity and safety of
      Recombinant Human Papillomavirus Vaccine (6,11,16,18,31,33,45,52,58 Type)(E.Coli)(hereafter
      called HPV vaccine), manufactured by Xiamen Innovax Biotech CO., LTD., in healthy adults aged
      18-45 years old.
    


Intervention name(s): HPV Vaccine,270μg/1.0ml; Placebo
Intervention type(s): Biological; Biological
Intervention description(s): HPV vaccine (270μg/1.0ml) administered intramuscularly according to a 0, 1, 6 month vaccination schedule.; Aluminium adjuvant (1.0ml) administered intramuscularly according to a 0, 1, 6 month vaccination schedule.
Other intervention name(s): aluminium adjuvant
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: human papillomavirus vaccine
Pharmacokinetics of Decursin/Decursinol Angelate (CognIQTM)
Condition: Healthy
Study type: Interventional
Phase: Early Phase 1

Summary: 
      This study is to investigate how human bodies absorb and metabolize two herbal drugs. The
      information is critical for drug development and could not be obtained from any other studies
      using animals. The two herbal drugs are decursin and decursinol angelate (DA) which naturally
      exist in a traditional herb Angelica gigas Nakai (AGN). Preclinical and clinical studies
      indicated that AGN and decursin/DA were quite safe to animals and human.
    


Intervention name(s): 800mg dietary supplement CognIQTM (4 capsules) by oral at hour 0
Intervention type(s): Dietary Supplement
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: bio-availability; decursin; decursinol angelate; decursinol; subjects
Validation of Surrogate Measures in Irritable Bowel Syndrome (IBS)
Condition: Irritable Bowel Syndrome
MeSH terms: Irritable Bowel Syndrome; Syndrome
Study type: Interventional
Phase: Phase 4

Summary: 
      Visceral and somatic hypersensitivity as evidence of central sensory sensitization occur in
      the majority of Irritable Bowel Syndrome (IBS) patients. We recently demonstrated abnormal
      endogenous pain modulation as a cause of the sensitization in IBS and identified the
      underlying dysfunctional neuromatrix using functional MR-imaging (fMRI). Endogenous pain
      mechanisms regulate, fine-tune and integrate sensory and homeostatic, including
      neuroendocrine, immune and autonomic nervous system processes. Specific measures of
      sensitization and endogenous pain modulation correlate with clinical measures of somatic and
      neuropathic pain, suggesting usefulness as surrogate markers for clinical pain outcomes.
      Validation of experimental measures as surrogate markers in IBS would provide a considerable
      advance in pathophysiological and therapeutic research in this pharmacoeconomically
      burdensome disease.
    


Intervention name(s): Escitalopram treatment; Quantitative sensory testing
Intervention type(s): Drug; Behavioral
Intervention description(s): On study inclusion at Visit 2, patients will be successively randomised using a computer generated randomisation list to either placebo or escitalopram (Lundbeck Export A/S, Singapore) 10mg given at bedtime in the first 2 weeks, followed by 20mg in the next 6 weeks. The treatments will be identical in appearance and will be administered in double-blind fashion. Treatment with any anticoagulants, antidiabetics, antimigraine drugs, antispasmodics, analgesics, psychoactive agents including antidepressants, Zelmac®, TCM or acupuncture for IBS and any drugs affecting nociception as judged by investigator are prohibited during the entire study.; Rectal Distention Stimulation
Other intervention name(s): Lexapro
Intervention MeSH terms: Escitalopram
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Screening
G-Pen™ for Hypoglycemia Rescue in T1D Patients
Condition: Hypoglycemia
MeSH terms: Hypoglycemia
Study type: Interventional
Phase: Phase 2

Summary: 
      This is an open-label, exploratory pilot study in patients with T1D. The study will involve
      two daytime clinical research center visits 7-14 days apart. Subjects will receive a single
      injection of G-Pen™ (glucagon injection) at each visit.
    

Detailed description: 
      Following eligibility confirmation, each study participant will undergo two episodes of
      insulin-induced hypoglycemia with plasma glucose < 50 mg/dL. Both episodes will be treated
      with a single subcutaneous injection of G-Pen™ glucagon. For the first treatment visit, all
      subjects will receive a 1 mg dose of G-Pen™ glucagon. The investigator will have discretion
      to repeat this same dose at the second treatment visit or give a 0.5 mg dose of G-Pen™
      glucagon. A follow-up phone call will be conducted 3-7 days following administration of the
      final dose of study drug as a safety check.
    

Intervention name(s): Glucagon
Intervention type(s): Drug
Other intervention name(s): G-Pen™ (glucagon injection)
Intervention MeSH terms: Glucagon; Glucagon-Like Peptide 1
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Adverse Reactions Following COVID-19 Vaccination Among Ecuadorian Healthcare Workers
Condition: Adverse Drug Event
MeSH terms: COVID-19; Drug-Related Side Effects and Adverse Reactions
Study type: Observational

Summary: 
      Limited large-scale studies have been conducted to investigate the adverse effects of
      COVID-19 vaccine in Latin America, particularly among the healthcare worker (HCW) population
      in Ecuador. The objective of this study was to assess a cohort of Ecuadorian healthcare
      workers for adverse reactions following vaccination with the Pfizer-BioNTech vaccine.
    

Detailed description: 
      The COVID-19 pandemic bears a burden on medical care and economies worldwide, however
      immunization at the population level provides a way for to reduce future morbidity and
      mortality. Vaccine hesitancy and reluctance in getting the COVID-19 vaccine and apprehensions
      about them have been present along the course of vaccination programs and mass immunizations
      across the world. Factors such as the quick, large-scale production of vaccines, lack of
      information, and uncertainty about adverse reactions in the public's eye as well about myths
      spreading through media channels have given rise to suspicion and fear in the Latin American
      population. Limited large-scale studies have been conducted to investigate the adverse
      effects of COVID-19 vaccine in Latin America, particularly among the healthcare worker (HCW)
      population in Ecuador. The objective of this study was to assess a cohort of Ecuadorian
      healthcare workers for adverse reactions following vaccination with the Pfizer-BioNTech
      vaccine.
    

Intervention name(s): Pfizer-BioNTech COVID-19 vaccine
Intervention type(s): Biological
Intervention description(s): Patients who were administered any dose of the Pfizer-BioNTech COVID-19 vaccine.
Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        The population included Ecuadorian healthcare workers who received the inoculation with the
        Pfizer-BioNTech COVID-19 vaccine.
      
Keywords: adverse reactions; COVID-19; healthcare workers; Latin America; vaccination
Trial of Integrated Smoking Cessation, Exercise and Weight Management in Serious Mental Illness: TRIUMPH
Condition: Mental Illness
MeSH terms: Mental Disorders
Study type: Interventional

Summary: 
      This study will determine whether an 18-month practical tobacco smoking cessation program
      integrating weight management counseling and exercise will be superior to treatment as usual
      in achieving prolonged smoking abstinence in persons with serious mental illness.
    

Detailed description: 
      The objective of this study is to perform a randomized clinical trial (TRIUMPH) in persons
      with serious mental illness to test the hypothesis that intervention participants will have
      higher rates of smoking abstinence at 18 months than participants in the treatment as usual
      arm. The intervention includes group and individual smoking cessation and weight management
      counseling tailored by a participant's readiness to quit, pharmacotherapy with either
      varenicline or buproprion plus nicotine replacement therapy prescribed in the community
      clinic, exercise, and text messaging supporting health behavior change.
    

Intervention name(s): TRIIUMPH Intervention
Intervention type(s): Other
Intervention description(s): Group and individual smoking cessation and weight management counseling, pharmacotherapy with varenicline or bupropion and nicotine replacement therapy, group exercise, and text messaging support
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: weight management; physical activity; Tobacco smoking; Serious mental illness
Muscle Tenderness and Hardness in Migraine Patients
Condition: Migraine Disorders; Muscle Tenderness; Headache Disorders, Primary; Nervous System Diseases; Headache, Migraine
MeSH terms: Myalgia; Migraine Disorders; Nervous System Diseases; Headache Disorders; Headache Disorders, Primary; Headache
Study type: Observational

Summary: 
      The aim of the study is to examine symptomatology, quantitative sensory test (QST)
      parameters, muscle tenderness and muscle hardness in migraine patients interictally and
      compare with healthy controls
    

Detailed description: 
      Migraine patients exhibit different symptomatology and responses to treatment. For example do
      many migraine patients have neck symptoms, despite they apparently do not have any neck
      disorders.Furthermore the response to treatment differs between patients. Differences in
      symptomatology, QST parameters and muscle stiffness can be used to subdivide and phenotype
      migraine patients.

      The investigators are examining migraine patients with:

      A semistructured interview, Quantitative sensory testing (cold pain threshold, heat pain
      threshold and Pin Prick), Muscle tenderness (total tenderness score, local tenderness score
      and stimulus response curve), and muscle hardness with ultrasound elastography. All tests are
      performed the same day
    

Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Migraine patients are recruited from the out-patient clinic at the Danish Headache Center.

        Healthy controls are recruited through web-sites.
Vibration and Cold for Pain Relief During Peripheral Intravenous Cannulation in Children With Intellectual Disability
Condition: Pain Relief
MeSH terms: Intellectual Disability
Study type: Interventional
Phase: Phase 3

Summary: 
      Needle procedures are the most common and important source of pain and distress in children
      in the health care setting. Children with intellectual disability from any cause experience
      pain more frequently than healthy children. They often require venipuncture or IV cannulation
      for diagnostic or therapeutic procedures. Pain in this population is often unrecognised
      because these patients are frequently unable to self-report their pain. Now it's possible to
      measure pain in children with intellectual disability with specific pain scales, like
      NCCPC-PV (Non-Communicating Children's Pain Checklist, Post-operative Version).

      The efficacy of a device combining vibration and cold for pain relief during venipuncture or
      IV cannulation has been recently reported in children. The device's actions are based on the
      Gate Control Theory, whereby cold and vibrations stimulate large fiber and inhibitory neurons
      to interrupt nociception. This non-pharmacologic technique for pain relief could be useful in
      this kind of patients in emergency department. To date, there is no study that validated
      Buzzy device for pain relief in children with intellectual disability.

      The aim of this study is to test the effectiveness of Buzzy® (a device that provides cold and
      vibration), in reducing the pain during venipuncture or IV cannulation, in children with
      intellectual disability.
    


Intervention name(s): Buzzy® device
Intervention type(s): Device
Intervention description(s): Buzzy® is a battery-powered device for venipuncture pain relief combining cold, vibration, and distraction.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Procedural pain; Phlebotomy; Intellectual Disability; Child; Buzzy
A Single Dose, 2-Period, 2-Treatment, 2-Way Crossover Bioequivalency Study of Balsalazide Disodium 750 mg Capsules Under Fasting Conditions
Condition: Ulcerative Colitis
MeSH terms: Colitis; Colitis, Ulcerative
Study type: Interventional

Summary: 
      The objective of this study was to assess the bioequivalence of a potential generic 750 mg
      balsalazide disodium capsule formulation compared with Salix Pharmaceutical's 750 mg
      balsalazide disodium capsule, Colazal, following a single 750 mg dose, administered under
      fasting conditions.
    


Intervention name(s): Balsalazide
Intervention type(s): Drug
Intervention MeSH terms: Balsalazide
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Phase I Study To Estimate The Effect Of Ketoconazole And Omeprazole On The Pharmacokinetics Of Dimebon In Healthy Subjects Who Are Normal Or Poor CYP2D6 Metabolizers
Condition: Alzheimer's Disease; Huntington's Disease
MeSH terms: Alzheimer Disease; Huntington Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will evaluate the potential for a drug-drug interaction of Dimebon with
      ketoconazole and omeprazole, potent inhibitors of the drug metabolizing enzymes CYP3A4 and
      CYP2C19, respectively.
    


Intervention name(s): Dimebon alone; Dimebon + Ketoconazole; Dimebon + Omeprazole
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Pharmacokinetics of a single oral dose of 10 mg Dimebon (tablet) will be assessed in subjects with a CYP2D6 extensive and poor metabolizer status based on genotyping as screening; Pharmacokinetics of a single oral dose of 10 mg Dimebon (tablet) will be assessed on Day 4 during the daily administration of ketoconazole (400 mg, Day 1-11) in subjects with a CYP2D6 extensive and poor metabolizer status based on genotyping as screening; Pharmacokinetics of a single oral dose of 10 mg Dimebon (tablet) will be assessed on Day 5 during the daily administration of omeprazole(40 mg, Day 1-12) in subjects with a CYP2D6 extensive and poor metabolizer status based on genotyping as screening
Intervention MeSH terms: Ketoconazole; Omeprazole
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Keywords: Drug Interactions; pharmacokinetics; CYP2D6; CYP2C19; ketoconazole; omeprazole
Efficacy and Safety of Gynostemma Pentaphyllum(Dungkulcha) Extract on Alleviation of Chronic Stress-induced Strain
Condition: Chronic Stress-Induced Strain
MeSH terms: Sprains and Strains
Study type: Interventional

Summary: 
      The investigators performed a 8-week, randomized, double-blind, placebo-controlled human
      trial to evaluate the efficacy and safety of Gynostemma Pentaphyllum(Dungkulcha) on
      alleviation of chronic stress-induced strain. The investigators measured decrement of body
      fat parameters, State&Trait version of STAI, Beck Anxiety Inventory(BAI), Hamilton Anxiety
      Inventory(HAM-A), and monitored their blood pressure.
    


Intervention name(s): Gynostemma Pentaphyllum(Dungkulcha) Extract(400mg/day); Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Gynostemma Pentaphyllum(Dungkulcha) Extract(400mg/day), parallel design; Placebo, parallel design
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention