bioihbjkbjnl/mcl2 huggingface dataset:
Docetaxel and GEM 231 in Treating Patients With Recurrent or Refractory Solid Tumors
Condition: Unspecified Adult Solid Tumor, Protocol Specific
MeSH terms: Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so
      they stop growing or die. Gene therapy such as GEM 231 may inhibit the growth of cancer cells
      and make the tumor more sensitive to chemotherapy.

      PURPOSE: Phase I trial to study the effectiveness of combining docetaxel and GEM 231 in
      treating patients who have recurrent or refractory solid tumors.
    

Detailed description: 
      OBJECTIVES: I. Determine the safety and maximum tolerated dose of docetaxel and GEM 231 in
      patients with recurrent or refractory solid tumors. II. Determine any preliminary antitumor
      activity of GEM 231 in this patient population.

      OUTLINE: This is a dose escalation study of GEM 231 and docetaxel. Patients receive docetaxel
      IV over 1 hour on day 1, immediately followed by GEM 231 IV over 2 hours on days 1, 4, 8, and
      11. Treatment continues every 3 weeks in the absence of disease progression or unacceptable
      toxicity. Cohorts of 3-6 patients are treated with escalating doses of GEM 231 and docetaxel
      until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which
      no more than 2 of 6 patients experience dose limiting toxicity. Patients are followed monthly
      for 3 months.

      PROJECTED ACCRUAL: A maximum of 1 patient will be accrued per week for this study until the
      maximum tolerated dose is reached.
    

Intervention name(s): GEM 231; docetaxel
Intervention type(s): Drug; Drug
Intervention MeSH terms: Docetaxel
Primary purpose: Treatment
Keywords: unspecified adult solid tumor, protocol specific
Trial in Periodontal Tissue Regeneration Using Fibroblast Growth Factor-2
Condition: Periodontitis
MeSH terms: Periodontitis
Study type: Interventional
Phase: Phase 2

Summary: 
      The present clinical trial clarified that basic fibroblast growth factor-2 (FGF-2) can induce
      regeneration of periodontal tissue lost by progression of periodontitis and evaluated the
      safety of such induction.
    


Intervention name(s): Trafermin (genetical recombinant of human basic Fibroblast Growth Factor)
Intervention type(s): Drug
Intervention MeSH terms: Mitogens
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Use of Prone Position Ventilation in Danish Patients With COVID-19 Induced Severe ARDS Treated With VV-ECMO
Condition: ARDS, Human; Extracorporeal Membrane Oxygenation; COVID-19 Acute Respiratory Distress Syndrome; Prone Position; Adverse Event
MeSH terms: COVID-19; Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn; Acute Lung Injury; Syndrome
Study type: Observational

Summary: 
      Prone position ventilation was used 220 times in 44 out of 68 patients with severe COVID-19
      induced ARDS treated with VV-ECMO. PPV treated patients did not benefit from PPV and the
      incidence of PPV related adverse events was high
    

Detailed description: 
      Purpose: To describe the use and effects of prone position ventilation (PPV) in patients with
      COVID-19 induced Adult Respiratory Distress Syndrome (ARDS), treated with Veno-Venous
      Extracorporeal membrane oxygenation (VV-ECMO).

      Methods: Nationwide retrospective analysis of all COVID-19 patients in Denmark from March
      2020 - December 2021with severe ARDS and need of VV-ECMO treatment. Data on the number of
      patients treated with PPV, number of PPV-events, timing, the time spent in prone position,
      physiological response types, adverse events and outcomes are reported.
    

Intervention name(s): Prone position ventilation
Intervention type(s): Other
Intervention description(s): Turning the patient prone for 16 hours
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        This is a nationwide retrospective cohort study of a cohort of 68 patients with PCR
        confirmed SARS-Cov-2 ARDS, treated with V-V ECMO in the two VV-ECMO centers in Denmark:
        Aarhus University Hospital in west Denmark and University Hospital Rigshospitalet in
        Copenhagen, East Denmark. Patients were admitted in the period from 17. March 2020 to 31.
        December 2021.
      
Keywords: ARDS; VV-ECMO; Prone position ventilation; Adverse Events
Antidepressant Treatment of Mexican-Americans: UCLA Pharmacogenetics and Pharmacogenomics Research Group
Condition: Major Depressive Disorder; Major Depression; Unipolar Depression
MeSH terms: Depression; Depressive Disorder; Depressive Disorder, Major
Study type: Interventional
Phase: Phase 2

Summary: 
      Our goal is to study pharmacogenetics in Mexican-Americans, using depression treatments as a
      proof of the concept that pharmacogenetic approaches can be used to optimize treatment
      strategies for common and complex disorders in this population.
    

Detailed description: 
      This is a single site, 8-week, double-blinded, placebo lead-in trial with fluoxetine or
      desipramine. All subjects have a comprehensive psychiatric and medical assessment, and if
      enrolled, continued with two consecutive phases of the study: 1) A one-week, single-blind
      placebo lead-in phase to eliminate placebo responders. 2) Subsequent random assignment to one
      of two treatment groups: fluoxetine 10-40 mg/day or desipramine 50-200 mg/day. Given the
      proven efficacy of these antidepressant medications, a placebo lead-in period followed by
      active treatment for all patients has been utilized in order to minimize human subjects at
      risk.
    

Intervention name(s): fluoxetine or desipramine
Intervention type(s): Drug
Intervention description(s): fluoxetine 5-40 mg/day desipramine 50-150 mg/day
Other intervention name(s): Prozac
Intervention MeSH terms: Fluoxetine; Desipramine
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment
Keywords: Depression; mood disorders; affective disorders; pharmacogenetics; pharmacogenomics
Interaction Between a Natural Aldehyde Dehydrogenase 2 (ALDH2) Inhibitor and Alcohol
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The main objective is to assess whether a natural inhibitor of aldehyde dehydrogenase 2
      (ALDH2) contained in a soy extract could interfere on alcohol metabolism and effects in
      humans.
    

Detailed description: 
      Soybeans contain isoflavones, which are biologically active polyphenols known as antioxidants
      and phytoestrogens. These isoflavones include daidzin, daidzein, genistin and glycitin, and
      have been implicated in the beneficial effects of soy consumption.

      Daidzin and daidzein are isoflavones contained in soybean that can act as natural inhibitors
      of aldehyde dehydrogenase 2. Animal studies have demonstrated that some soy isoflavones can
      reduce the auto-administration of cocaine and suggest they might be useful to treat cocaine
      dependence.

      Aldehyde dehydrogenase inhibitors, as disulfiram, are currently used in humans to treat
      alcohol dependence because they interfere with ethanol metabolism (specifically in the
      transformation of acetaldehyde to acetate.

      Alcohol intake after disulfiram administration increases concentration of acetaldehyde in the
      blood (five to 10 times higher than that found during metabolism of the same amount of
      alcohol alone). The combination produced acute symptoms of a severe "hangover" (named
      disulfiram-like reaction), and the patient may experience symptoms as flushing of the skin,
      tachycardia, shortness of breath, nausea, vomiting, throbbing headache, visual disturbances,
      mental confusion, and in some cases severe reactions as postural syncope, and circulatory
      collapse.

      In addition, disulfiram have demonstrated clinical efficacy in cocaine dependence. The
      mechanism of action for that effects are related to its ability to decrease dopamine
      degradation by inhibiting the dopamine-beta-hydroxylase enzyme (metabolizes dopamine to
      norepinephrine), and increasing its concentrations in some areas of the brain.

      The aim of the study is to assess whether a soy extract containing isoflavones (daidzin,
      daidzein and genistein) could interfere on alcohol metabolism and produce adverse effects in
      humans.
    

Intervention name(s): Daidzin; Alcohol
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Super-Absorbable Soy Isoflavones, LifeExtension, USA. Single oral dose of 4 capsules (containing 80 mg of daidzin-daidzein).; Alcohol single oral dose
Intervention MeSH terms: Daidzin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
A Study of a Single Dose of ASP3291 in Subjects With Ulcerative Colitis
Condition: Ulcerative Colitis
MeSH terms: Colitis; Colitis, Ulcerative; Ulcer
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine the pharmacokinetics (PK) and to assess safety and
      tolerability of a single dose of ASP3291 in subjects with ulcerative colitis.
    

Detailed description: 
      After an 11-day screening period, subjects check into a clinic, are dosed on Day 1 and stay
      in the clinic for 4 days to monitor pharmacokinetic and safety parameters.
    

Intervention name(s): ASP3291; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Oral tablets; Oral tablets
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Keywords: Ulcerative colitis; ASP3291
Mild, Moderate and Severe Renal Impairment Study
Condition: Gout
MeSH terms: Renal Insufficiency
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a Phase 1, single-dose, open-label, pharmacokinetic (PK) and pharmacodynamic (PD)
      study of RDEA3170 in adult male subjects with mild, moderate, and severe renal impairment.
    


Intervention name(s): RDEA3170
Intervention type(s): Drug
Intervention MeSH terms: Verinurad
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
A Study To Understand How Radiolabelled PF-04449913 Is Taken Up By The Body, Broken Down And Then Removed From The Body
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The study aims to understand, using radiolabelled PF-04449913, how this compound is modified
      by the body once it is absorbed. The study also aims to understand how much of the compound
      is broken down and how much leaves the body unchanged.
    


Intervention name(s): [14C] PF-04449913
Intervention type(s): Drug
Intervention description(s): Single oral dose of 100 mg PF-04449913 + 100µCi of [14C] PF-04449913
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: PF-04449913; [14C]PF-04449913; Human ADME; Radiolabel; Mass Balance; Pharmacokinetics
Effectiveness of Dental Trauma Educational Poster to Secondary Students
Condition: Injuries
Study type: Interventional

Summary: 
      to investigate the effectiveness of the educational poster regarding knowledge of dental
      trauma for the secondary school students
    

Detailed description: 
      To investigate the effectiveness of the educational poster about dental trauma to increase
      the knowledge of secondary students.

      Schools will be randomly divided into two groups, baseline score of knowledge in
      questionnaire will be collected for all subjects. Poster will be sent to intervention group,
      the school will place it at the notice broad or area of similar function in the classroom.
      For the control group, nothing will be given, then after 2 weeks, the score of knowledge by
      the second questionnaire of both groups will be collected again.

      To compare the difference in knowledge before and after in both groups, statistical test will
      be performed.

      Investigators conduct a cluster randomized controlled trial. A list of secondary schools was
      requested from the Education Bureau. Secondary schools will be invited to join the study and
      then randomized to the intervention group and the control group in the unit of school using
      computer generated numbers. All students will fill in the first questionnaire and send it
      back to the investigator in 1 week. Then copies of the same poster will be given to the
      intervention schools, these schools will be requested to place them in the classrooms of the
      participating students. No poster will be given to the control group. After 2 weeks, the
      poster will be removed. The same questionnaire will be filled out by all the students in both
      groups and sent back in 1 week. Then the data will be processed to show whether the poster is
      effective to improve the knowledge of the students.
    

Intervention name(s): educational poster
Intervention type(s): Other
Intervention description(s): educational poster for dental trauma
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Keywords: educational poster, knowledge, dental trauma,
Diabetes Mellitus Care Decision Making Model Through Data Mining
Condition: Diabetes Mellitus
MeSH terms: Diabetes Mellitus
Study type: Observational

Summary: 
      We tried to use data mining method to find out the new model of factors that affects the
      progression of diabetes mellitus.
    

Detailed description: 
      The advanced development of medical technology had led to the accumulation of a large amount
      of medical data. Unfortunately, these useful and meaningful clinical data were not properly
      managed or analyzed. Therefore, data mining technology has become an essential instrument for
      hospital management and medical research. Possible meaningful information can be obtained
      from the database through data mining. About 2,000 diabetic patients had been enrolled in
      Diabetes Care Program since Oct 2002 in our hospital. We intend to look for the determining
      factors that affect the prognosis of diabetes mellitus in our patients group.
    

Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        This retrospective cohort study included 2,000 patients who visited our Division of
        Endocrinology and Metabolism outpatient department in this hospital with the diagnosis
        diabetes mellitus who had been enrolled into the Diabetes Care Program from year 2002 until
        2007.
      
Keywords: diabetes mellitus; care decision; data mining
Study of the Link Between Psychosocial Treatments and the Need of Pharmacological Treatments in Children With Attention Deficit Hyperactivity Disorder
Condition: Attention Deficit Hyperactivity Disorder; Youths
MeSH terms: Hyperkinesis; Attention Deficit Disorder with Hyperactivity
Study type: Observational

Summary: 
      The Attention Deficit and Hyperactivity Disorder (ADHD) is a frequent disorder in children
      and adolescents. The diagnosis is clinical with the input of several informants (child,
      family, teachers, …). ADHD is a risk factor for academic difficulties, school dropout, social
      isolation, injury, oppositional behaviour. In school-age children and adolescents having
      moderate to high or persistent impairment despite psycho-educational support and
      environmental modification, the first-line treatment is methylphenidate. Group or individual
      cognitive behavioural therapy for parents and/or children and adolescents is recommended for
      co-occurring disorders and persistent impairment. In France, the initiation of
      methylphenidate requires an annual hospital prescription by a paediatrician or psychiatrist,
      and a regular medical supervision (weight, heart rate, blood pressure, …). At least once a
      year, the indication of methyphenidate needs to be re-evaluated and confirmed at the
      hospital. In case of lack of efficiency and/or poor tolerance, therapeutic alternatives
      including non-psychostimulants should be considered.

      A randomized controlled trial evaluated the dose of methylphenidate received over a period of
      13 months. It was observed that the "combined treatment" group (methylphenidate +
      psychosocial treatments) received a lower average dose of methylphenidate than the
      "methylphenidate alone" group. These results are difficult to extrapolate to the general
      population, due to the study protocol (regular monitoring of ADHD symptoms with the aim of
      total remission).

      For a global consideration of children's needs, it is important to better understand the
      interactions between these two therapeutic approaches.

      To participate in the study, parents will have to complete an online questionnaire. This
      questionnaire contains anamnestic data collection, questionnaires to assess ADHD symptoms and
      parenting practices.
    


Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Children diagnosed with ADHD, treated by methylphenidate, from primary care and community
        sample.
      
Biospecimen description: 
      NC
    
Keywords: ADHD; treatment with methylphenidate; behavioral parent training
Effects of Romantic Affection on Blood Chemistry and Immune Parameters
Condition: Stress; Hypercholesterolemia
MeSH terms: Hypercholesterolemia
Study type: Interventional
Phase: Early Phase 1

Summary: 
      This trial tests the hypothesis that increasing nonverbal affection in romantic relationships
      will improve blood lipid parameters (total cholesterol, high and low density lipoproteins,
      triglycerides), blood glucose, and immune parameters (C-reactive protein and antibodies to
      latent Epstein-Barr virus). 52 healthy cohabiting romantic couples took part. In half of the
      couples, one partner increased the frequency of romantic kissing with the other partner
      during the six-week trial. The other couples received no such instruction. Blood tests
      performed before and after the trial were used to assess the health outcomes.
    


Intervention name(s): Romantic kissing
Intervention type(s): Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single
Primary purpose: Treatment
Association of Force Distribution and Bone Resorption
Condition: Bone Resorption
MeSH terms: Bone Resorption
Study type: Interventional

Summary: 
      To investigate the residual ridge resorption at anterior and posterior maxillary and
      posterior mandibular ridges among conventional complete dentures and implant overdenture
      wearers, and determine its association with the relative occlusal forces distribution,
      treatment groups and other patient variables.
    

Detailed description: 
      A total of forty-six edentulous patients participated in this clinical study divided into two
      groups as following; complete denture group (CD) consists of 23 patients wearing conventional
      complete dentures and another Implant overdenture group (IOD) consists of 23 patients wearing
      mandibular complete overdenture with 2 implants. Two panoramic radiographs at baseline and in
      a follow-up to 7 years were used to measure the ratio of bone changes between the anatomical
      bone area and the reference area in the maxillary and the mandibular ridges. The occlusal
      contacts percentage of force in maximum intercuspation anteriorly and posteriorly were
      recorded for both groups by using T-Scan III system.

      Oral and written information in English or Malay language, regarding the study, was provided
      and written consent obtained before enrolment.
    

Intervention name(s): Panoramic Radiograph; T-Scan III occlusal system
Intervention type(s): Radiation; Device
Intervention description(s): Measurement of bone resorption; Recording percentage of force in maximum intercuspation
Intervention MeSH terms: Salicylic Acid
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Efficacy and Safety Study of NKTR-181 in Opioid-Naive Subjects With Low Back Pain
Condition: Low Back Pain; Chronic Pain
MeSH terms: Back Pain; Low Back Pain; Chronic Pain
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to determine whether a new opioid molecule, NKTR-181, is
      effective for the relief of moderate to severe chronic low back pain as compared to a
      placebo.
    

Detailed description: 
      This is an enriched enrollment, randomized withdrawal study with an open label,
      dose-titration period followed by a randomized, double-blind, placebo-control treatment of
      twelve weeks. During the double-blind treatment period, this study will evaluate the
      analgesic effect of NKTR-181 versus placebo in patients with moderate to severe chronic low
      back pain.
    

Intervention name(s): NKTR-181 BID tablets; Placebo to match NKTR-181 BID tablets
Intervention type(s): Drug; Drug
Intervention description(s): NKTR-181 tablets 100-400 mg twice daily (BID); Placebo to match NKTR-181 tablets 100-400 mg twice daily (BID)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Examining the Effectiveness of Digestive Enzymes at Reducing Bloating and Stomach Distension
Condition: Stomach Distended; Bloating
MeSH terms: Gastric Dilatation; Dilatation, Pathologic
Study type: Interventional

Summary: 
      Flatter Me is a product that includes digestive enzymes in a way to support digestion of
      macronutrients and their constituents and provides herbs traditionally used for digestive
      health support. This trial aims to test Flatter Me against a placebo pill to examine
      differences in both subjective outcomes (feelings of bloating and indigestion) and changes in
      waist circumference (abdominal distension) after eating a test meal.
    


Intervention name(s): HUM Flatter Me
Intervention type(s): Dietary Supplement
Intervention description(s): Proprietary Enzyme Blend: Protease 3.0 Protease 4.5 Protease 6.0 Neutral Bacterial Protease Peptidase Bromelain Papain Lipase Amylase Glucoamylase Alpha-galactosidase Invertase Diastase Hemicellulase + Cellulase Beta-Glucanase Phytase Lactase Ginger Root Fennel Seed Peppermint Leaf
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: digestion; bloating