bioihbjkbjnl/mcl2 huggingface dataset:
Evaluation of Pesticide Exposure in the General Population
Condition: Pesticide Poisoning
MeSH terms: Poisoning
Study type: Observational

Summary: 
      An association has been suggested with several diseases including cancer and IARC has
      classified several pesticides as carcinogenic, probably carcinogenic. There is a need for a
      better characterisation of environmental pesticides exposures and identification of suitable
      biomarkers of exposure and effect. A better understanding of the impact of pesticide exposure
      on metabolomic, transcriptomic and epigenetic changes, is essential to strengthen
      epidemiological hypotheses on the association with several cancer types.

      The main objective of the project is to validate a GIS (geographic information system) based
      method to assess environmental pesticide exposures, using environmental (contamination of
      housedust) and biological (blood and urine samples) measures. The project aims further to
      investigate a potential link between housedust contamination and biological measures in
      healthy non-smoking male residents and explore the impact of environmental pesticide exposure
      on metabolomics, transcriptomic and epigenetic parameters.
    

Detailed description: 
      The project involves a pilot phase involving repeated (twice) sampling in 20 male non-smoking
      volunteers living in the Beaujolais region (France) to perform appropriate calibrations for
      metabolomic, transcriptomic and epigenetic analyses. The main study will be conducted in a
      sample of 150 male non-smoking volunteers and 50 professional pesticides applicators from the
      same region (3 sampling periods).
    

Intervention name(s): Questionnaire, blood, urine, hair and dust samplings
Intervention type(s): Biological
Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Healthy volunteers living in the Beaujolais region (France)
Single Dose Glumetinib in Healthy Chinese Male Subjects
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a phase I, single-center, randomized, open-label, single-dose, three-period (fasting,
      high-fat meal, low-fat meal) crossover clinical study to investigate the food effect on PK of
      the recommended phase II dose (RP2D) of 300 mg Glumetinib, based on the previous clinical
      studies of Glumetinib monotherapy.
    

Detailed description: 
      Approximately 18 healthy adult male subjects are expected to be enrolled randomly into 6 meal
      sequences, with 3 subjects per sequence. Each subject receive Glumetinib given under fasting
      condition, after a high-fat meal, or following a low-fat meal, respectively, in three
      periods.Subjects enrolled in each period received 300 mg Glumetinib once and PK blood samples
      are collected after dosing once daily for 7 days.To clarify the occurrence of AEs, subjects
      should complete safety examinations on Day 8 of each period. Subjects with AE are followed up
      before the next period of administration. Before the next administration, subjects with no AE
      or ongoing AE with Common Terminology Criteria for Adverse Events (CTCAE) Grade 1 enter into
      the next period and continued receiving dosing; subjects reported AEs with CTCAE Grade higher
      than 1 are discontinued from the study and are followed up by investigator until the AE
      disappeared, stabilized, return to baseline or lost to follow-up (whichever occurred first)
    

Intervention name(s): Glumetinib
Intervention type(s): Drug
Intervention description(s): Fasting: Subjects are fasted overnight (at least 10 hours before administration) and receive Glumetinib tablets with 240 mL warm water the next morning.
Fed (high-fat meal/low-fat meal): Following an overnight fast for at least 10 hours, subjects finished a high-fat meal, or a low-fat meal within 30 minutes the next morning (eat up all meals). Glumetinib tablets are orally administered by subjects with 240 mL warm water on 30 minutes after starting the meal. Water is allowed as desired except for 1 hour before and 2 hours after administration (including the meal), and no more than 500 mL of water will be consumed including the water intake during the high-fat meals or low-fat meals, and the water for administration. The subjects will be fasted for at least 4 hours after administration, and then have dinner approximately 9 hours after administration.
Other intervention name(s): SCC244
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: Healthy Chinese Male Subjects; SCC244; Food effect
SAM-e for the Treatment of Depression in Patients With Parkinson's Disease
Condition: Parkinson's Disease; Depression
MeSH terms: Parkinson Disease; Depression; Depressive Disorder
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      This study will test a chemical called s-adenosyl-methionine (SAM-e) for the treatment of
      depression in patients with Parkinson's disease (PD).
    

Detailed description: 
      PD is commonly associated with depression, but conventional antidepressants have limited
      efficacy in patients with PD and may exacerbate motor symptoms. SAM-e is available in the
      United States as a food supplement and is promoted as a mood enhancer. SAM-e improves
      dopamine transmission, may have a beneficial effect on dopamine receptors, and may be a good
      alternative to the currently-used antidepressants in patients with PD. This study will
      investigate whether SAM-e is safe and effective in the treatment of depression associated
      with PD. The efficacy of SAM-e will be compared to placebo and to escitalopram, a selective
      serotonin reuptake inhibitor commonly used for the treatment of depression in PD.

      Participants in this study will be randomly assigned to receive SAM-e, escitalopram, or
      placebo for 12 weeks. Some participants may choose to extend treatment for an additional 12
      weeks (for a total of 24 weeks on study medication). Participants will have study visits at
      entry and Weeks 2, 4, 8, and 12. Study visits will include neurological evaluation,
      psychiatric evaluation, blood tests, and quality of life questionnaires. A telephone
      interview will be conducted at Week 10.
    

Intervention name(s): SAM-e; oral escitalopram; placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): oral SAM-e in two divided doses, 1200mg or 1800mg daily, with placebo escitalopram.; 20mg or 30mg daily in two divided doses, along with placebo SAM-e.; oral placebo escitalopram and oral placebo SAM-e daily in two divided doses.
Other intervention name(s): 1 Experimental
Intervention MeSH terms: Escitalopram
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Parkinsons Disease; Depression; SAM-e
Shamanic Healing for Women With Temporomandibular Joint Disorders (TMDs)
Condition: Temporomandibular Disorders
MeSH terms: Temporomandibular Joint Disorders; Temporomandibular Joint Dysfunction Syndrome
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a Phase I study to examine the feasibility and safety of shamanic (spiritual) healing
      for treating temporomandibular joint disorders (TMDs).
    

Detailed description: 
      Traditional systems of healing, such as shamanism, do not readily lend themselves to
      conventional research methods, yet studying their effectiveness is especially germane in the
      case of chronic conditions that involve an emotional component and that elude allopathic
      treatment regimens. Temporomandibular joint disorders (TMDs), which affect up to 10% of the
      adult population, are a prime example of such conditions. Traditional treatment outcomes for
      TMD pain are often unsatisfactory. Moreover, in women age 25-55 (the age-sex group most
      affected), TMD is often found in association with depression, anxiety, sleep disturbances,
      gastrointestinal symptoms, frequent infection,and fibromyalgia. Because these multiple and
      complex symptoms suggest a loss of spirit or life energy, they may be particularly
      susceptible to treatment by shamanic (spiritual) healing, which aims to bring disturbed
      physical, mental, and emotional systems into balance. This phase I study will develop methods
      to evaluate shamanic healing as an intervention for TMD and will evaluate the feasibility of
      conducting randomized clinical trials of shamanic healing.
    

Intervention name(s): shamanic healing
Intervention type(s): Procedure
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: temporomandibular disroders; shamanism; chronic pain
CASITA Intervention for Children at Risk of Delay in Carabayllo, Peru
Condition: Child Developmental Delay; Child Development; Community Health Workers; Low Income Population
Study type: Interventional

Summary: 
      Building on an intervention for early child development from the SPARK Center in Boston,
      Socios En Salud (SES) pilot tested "CASITA" a community-based package to screen and treat
      young children (ages 1-3 years of age) diagnosed with neurodevelopment risk and delay in
      Carabayllo, Lima, Peru. Ministry of Health CHWs identified children with developmental delays
      within the clinics and community and delivered a structured early intervention that included
      parent coaching and social support. In order to test the hypothesis that CASITA improves
      early child development, caregiver, and home environment, dyads received either nutrition
      supplements alone, nutrition + "CASITA" early child development sessions individually, or
      CASITA in a group of 10 dyads.
    


Intervention name(s): CASITA
Intervention type(s): Other
Other intervention name(s): Child development coaching and social support in Lima Peru; Community-based intervention for children at risk of Neurodevelopment delay
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
TAS1R1, TAS1R3, TLR2, TLR4, CA6 Gene Polymorphism on Dental Caries
Condition: High Caries Risk; Low Caries Risk
Study type: Observational

Summary: 
      The aim of this study is to examine the effects of TAS1R1, TAS1R3, TLR2, TLR4, CA6, gene
      polymorphism on caries risk in adults.
    

Detailed description: 
      To date, genes can be grouped into categories based on the factor influencing dental caries.
      The major candidate gene categories to date include enamel formation genes, immune response
      genes, genes related to saliva, and genes related to taste and dietary habits.

      CA6 exists in the human saliva and has a critical role of buffering, immune response and
      taste.Toll-like receptors are expressed in the tongue gustatory papillae where they may
      initiate immune responses to pathogens.Genetic variations in the TAS1R1 and TAS1R3 for umami
      cause perception of these tastes differently.
    

Intervention name(s): high caries risk; caries activity
Intervention type(s): Genetic; Other
Intervention description(s): DNAs were obtained from epithelial cells in buccal mucosa and were extracted with Genomic DNA Isolation Kit Genotyping for a variant was carried out on a Roche Applied Science LightCycler® 480 (Roche Diagnostics GmbH, Mannheim, Germany) with real-time polymerase reaction of Taqman; Dental caries lesions of all patient scored as initial, moderate or advanced caries
Initial lesion; clinically detectable lesion Moderate; visible signs of enamel breakdown Advanced; enamel was fully cavitaed
Other intervention name(s): DNA isolation, genotyping
Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Power analysis was performed with the G-Power software package. It was determined that a
        total of 200 patients will be needed: 100 (DMFT ≤ 5) for the low caries risk group and 100
        (DMFT ≥ 14) for the high caries risk group
      
Biospecimen description: 
      DNA for genetic analysis was isolated from buccal epithelial cells
    
Keywords: caries risk, gene polymorphisms
Exercise in Pediatric Cancer Patient Undergoing Anti-Cancer Treatment
Condition: Childhood Cancer
Study type: Interventional

Summary: 
      Today about 80% childhood cancer patients become long-time survivors. In spite of the high
      cure rates the diagnosis cancer is associated with a variety of disease and treatment-related
      psychological and physical impairments mostly present into adulthood. So the attention has to
      focus on the improvement of these problems such as motor limitation, dysfunction of the
      cardiovascular system, reduced muscle strength, overweight, osteoporosis and diminished
      quality of life (Qol). Although exercisel intervention studies in this field are generally
      scarce, the results of these studies are promising. Up to now studies during the acute phase
      of treatment are missing almost completely. The aim of this feasibility study is to evaluate
      the potential benefits of a modular exercise intervention program for childhood cancer
      patients startunf in parallel with treatment and longlasting for one year. Across two years
      cancer patients of the Children's Hospital of the University Clinic of Heidelberg aged 5-21
      years, free of any contraindications for physical activity will be recruited. All
      participants are asked to complete a physical assessment battery (strength, endurance and
      balance capacity, posture control, functional mobility, range of motion) and additionally two
      questionnaires concerning Qol and motivation, at baseline and every three months following
      one year
    


Intervention name(s): Multimodal Exercise Intervention
Intervention type(s): Behavioral
Intervention description(s): During their inpatient hospitalization the participants perform 3-5x weekly guided training sessions about 15-30min. The intervention includes: game console-based training using Nintendo Wii® (endurance, strength endurance and balance), age-specific resistance training and sessions of body awareness. During the outpatient phases the participants perform a home-based exercise training 3-5x weekly using a training manual. In addition, the patients obtain a movement diary and a pedometer for documenting their activity level.
Allocation: Non-Randomized
Intervention model: Factorial Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Exercise; Pediatric oncology; Physical Performance; Quality of Life; Feasibility; during primary; anticancer treatment
Standard Operating Procedures for Anti-HPV (Human Papillomavirus) Antibody Detection in First-void Urine
Condition: Human Papilloma Virus Infection
MeSH terms: Papillomavirus Infections; Papilloma
Study type: Observational

Summary: 
      The aim of the study is to develop and implement robust analytical protocols for first-void
      urine sample preparation and antibody assays to monitor vaccine induced immunity against HPV
      (Human Papillomavirus).
    

Detailed description: 
      Participants of the HPV V503-004 study (Phase III Clinical trial vaccinating (young) adult
      women in Antwerp, EudraCT NUMBER: 2015-005093-38) will be asked if they are willing to
      provide two additional urine samples at day 1 and month 7 for biomedical research.
      Furthermore, they will be contacted again at approximately 3.5 years and asked if they are
      willing to provide an additional urine sample and a serum sample. At 3.5 years, they will
      also be asked to fill in a brief questionnaire. The collected urine will be used for the
      development and optimization of robust analytical protocols for sample preparation and
      antibody assays.
    

Intervention name(s): First-void urine collection; Blood draw
Intervention type(s): Other; Other
Intervention description(s): Collection of ca. 20 ml of first-void urine with the Colli-PeeTM device (Novosanis) during visit at the Centre for the Evaluation of Vaccination.; Blood sample collection (5-10 cc) by a study nurse of Centre for the Evaluation of Vaccination.
Other intervention name(s): FV urine; Serum sample
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        In total 63 women are included in this trial. During their first two study visits, at day 0
        and 7m post-vaccination, participants are asked to collect a first-void urine sample with
        the Colli-PeeTM device (n=63). During their third visit, the included women are asked to
        collect a third first-void urine sample with the Colli-PeeTM device (n = 58). Hereafter, a
        blood sample of 5-10 cc is collected. Following sample collection, women are asked to fill
        in a questionnaire (n=58).
      
Biospecimen description: 
      First-void urine samples (3) and serum samples (1)
    
Keywords: Antibodies; Vaccination; Self-sampling; First-void urine; HPV
Cost-utility Analysis of the Outpatient Versus Conventional Hospitalization in Treatment of Occlusive Arterial Disease
Condition: Peripheral Arterial Disease
MeSH terms: Peripheral Arterial Disease; Peripheral Vascular Diseases; Arterial Occlusive Diseases
Study type: Interventional

Summary: 
      The purpose of this study is to assess the efficiency of outpatient surgery compared to
      conventional hospitalization in endovascular treatment of occlusive arterial disease. A
      cost-utility analysis will be conducted from a societal perspective. Patients referred for
      peripheral arterial disease (PAD) will be randomized in two arms and a 3 months follow-up
      will be performed.
    

Detailed description: 
      Rationale for ambulatory hospitalization is based on increased demand of hospital care,
      hospital budgets constraints and patients who ask for a prompt recovery. Consequently,
      physicians should find ways to optimize the resources' allocation, without compromising
      quality, safety and efficiency of patient care. Several studies and routine practice have
      shown that ambulatory hospitalization was safe but we are still lacking evidence to
      demonstrate the cost-utility of this kind of management.
    

Intervention name(s): Treatment of Occlusive Arterial Disease
Intervention type(s): Procedure
Intervention description(s): Regarding the intervention, the technique used during the diagnostic and/or therapeutic procedure shall be left to the operator's discretion, except the use of an arterial closure device (ACD). In the ambulatory hospitalisation arm, the ACD use will be mandatory. In the conventional hospitalisation arm, ACD will be used at the discretion of the interventionalist.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Outpatient hospitalization; Randomized trial; Peripheral arterial disease; Endovascular treatment; Health Economics
Impact of Neuromonitoring During Cardiac Procedures
Condition: Delirium; Stroke; Acute Kidney Injury
MeSH terms: Acute Kidney Injury
Study type: Observational

Summary: 
      Through a series of sequential analyses, retrospective database exploration looking for
      linkages and associations between the use of processed electroencephalogram (EEG) and/or
      cerebral saturation monitoring and patient outcomes post-cardiothoracic surgery will be
      explored.
    

Detailed description: 
      The purpose of this study is to mine the Premier Healthcare Database to:

        1. define the incidence of post-operative cognitive complications, acute kidney injury and
           stroke after specific cardiac surgical procedures (defined as: coronary artery bypass
           graft [CABG], Aortic Valve Replacement, Mitral valve repair, Mitral valve replacement,
           thoracic aortic operation, combined CABG and Valve replacement or repair ; and

        2. Determine the incremental increase in the length of hospitalization and cost of
           hospitalization among cardiac surgical patients who suffer postoperative cognitive
           complications, acute kidney injury and stroke; and

        3. Determine the effectiveness of intraoperative neuromonitoring with cerebral saturation
           and/or processed electroencephalogram (EEG) monitoring on the incidence of
           post-operative cognitive complications, acute kidney injury and stroke as a consequence
           of specific cardiac surgery procedures.

      The Premier Healthcare Database is a privately owned database that represents approximately
      1/5th of all United States hospitalizations annually. It includes all International
      Classification of Diseases-9th Revision (ICD-9) and International Classification of
      Diseases-Clinical Modification (ICD-9-CM) diagnosis and procedure codes recorded by the
      hospital, as well as a limited set of Current Procedural Terminology (CPT)-4 codes. Within
      the database, discharge-level data include information on patient and provider
      characteristics, diagnoses and procedures, hospital resource utilization, and charges/cost
      data for all entries, including pharmacy charges.
    

Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        All adult (age >=18 years) inpatients who underwent major cardiac surgical procedure
        requiring cardiopulmonary bypass captured in the Premier database from January 1, 2010 -
        December 31, 2014 (5 year period).