bioihbjkbjnl/mcl2 huggingface dataset:
Biological Markers in Attention Deficit/Hyperactivity Disorder (ADHD)
Condition: Attention Deficit and Disruptive Behavior Disorder; Attention Deficit Disorder With Hyperactivity
MeSH terms: Hyperkinesis; Attention Deficit Disorder with Hyperactivity; Mental Disorders; Problem Behavior; Attention Deficit and Disruptive Behavior Disorders
Study type: Observational

Summary: 
      The purpose of this study is to evaluate individuals with Attention Deficit/Hyperactivity
      Disorder (ADHD) to learn more about the genetics of the disease.

      This study is part of other ongoing studies of individuals with ADHD. The study participants
      have already undergone neurobiological measurements, particularly magnetic resonance imaging
      (MRI) of the brain, through other research studies. As a follow-up to these studies,
      participants will next undergo psychiatric interviews, neuropsychological tests, and another
      MRI. In addition to the clinical evaluation of the participants, further research will be
      conducted on the genetics of ADHD. These genetic studies will evaluate people with ADHD as
      well as their family members and a control group of healthy people.
    

Detailed description: 
      This protocol allows the continuing prospective longitudinal study of ADHD probands for whom
      we have neurobiological measures, particularly quantitative brain MRI. The follow-up consists
      of structured psychiatric interviews, and neuropsychological tests. Repeat MRI scans are
      obtained through protocol 89-M-0006.

      The second purpose of this protocol is a study of the genetics of
      Attention-Deficit/Hyperactivity Disorder (ADHD). Subjects who have ADHD, their family
      members, and controls are studied under this protocol.
    

Keywords: Attention Deficit Hyperactivity Disorder; Disruptive Behavior Disorders; Cerebrospinal Fluid; Lumbar Puncture; CSF; Longitudinal Prospective Follow-Up; Psychosocial Functioning; Risk Factors; Genetics
Effect of Lidocaine Spray for Pain Relief During Endometrial Biopsy: a Randomized, Double-blind, Placebo-controlled Clinical Trial
Condition: Pain
Study type: Interventional

Summary: 
      The effect of lidocaine spray on pain relief during endometrial sampling.
    

Detailed description: 
      The study population will comprise women with abnormal uterine bleeding who will be scheduled
      for endometrial sampling or women who will have control biopsies before surgery due to other
      pathologies. We have two groups; the first group consisted of patients who receive lidocaine
      spray. The second group consisted of patients who receive placebo spray. Patients will be
      asked to rate their pain level on a standard continuous 100-mm VAS to quantify the pain. Pain
      scoring will be performed at 3 different time points: immediately before to the procedure,
      during the procedure(immediately following the removal of the speculum from the vagina at the
      end of the endometrial sampling, the patients will be asked to score their pain level
      experienced during the procedure), and 15 minutes after the procedure.

      We will document the patients' demographics and medical information. All procedures will be
      performed by a single operator and the same team to avoid possible operator-dependent pain
      factors (counseling, patient preparation, attitude and operative steps during operation,
      moral and psychological support).
    

Intervention name(s): Lidocaine Spray; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): These patients received 2 puff lidocaine spray
Intervention MeSH terms: Lidocaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Curettage;; Pain Score
Molecular Surveillance of Artemisinin Resistance Malaria in Myanmar
Condition: Drug Resistance; Plasmodium Falciparum Malaria
MeSH terms: Malaria; Malaria, Falciparum
Study type: Observational

Summary: 
      Efficacy and safety of the artemisinin combination therapy (ACT) in uncomplicated falciparum
      malaria patients in Myanmar and artemisinin molecular markers analysis
    

Detailed description: 
      The investigators assessed the efficacy and safety of the ACT in uncomplicated falciparum
      malaria in different sentinel sites in Myanmar. The recruited patients were follow-up until
      day 28 or day-42 based on the ACTs. Day-0 samples were analysed for artemisinin molecular
      markers, (K13 kelch propeller, Pfmdr2, Pffd and Pfarps10).
    

Intervention name(s): First line antimalarial in Myanmar (artemether-lumefrantrine, dihydroartemisinin-piperaquine, and artesunate-mefloquine)
Intervention type(s): Drug
Intervention description(s): Being a observational cohort study, one of the ACT was selected in each study site to assess the efficacy and safety.
Intervention MeSH terms: Artesunate; Artemether; Piperaquine; Artenimol; Mefloquine; Antimalarials
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Study populations were selected purposely based on the previous evidence of the drug
        resistance in Myanmar
      
Biospecimen description: 
      Finger prick blood samples were taken onto filter paper and Keep dry until DNA extraction.
Safety, Tolerability and Immunogenicity of INO-4500 in Healthy Volunteers
Condition: Lassa Fever
MeSH terms: Lassa Fever
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a randomized and double-blinded within study group, placebo-controlled trial to
      evaluate the safety, tolerability and immunological profile of INO-4500 administered by
      intradermal (ID) injection followed by electroporation using the CELLECTRA® 2000 device in
      healthy adult volunteers.
    


Intervention name(s): INO-4500; Placebo; CELLECTRA® 2000
Intervention type(s): Drug; Drug; Device
Intervention description(s): INO-4500 will be administered ID on Day 0 and Week 4.; Placebo will be administered ID on Day 0 and Week 4.; EP using the CELLECTRA® 2000 device will be administered following ID drug administration.
Other intervention name(s): SSC-0001
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Prevention
Keywords: Healthy volunteer
Testing the Use of Prompts to Increase Adolescent Immunization Rates
Condition: Vaccine Preventable Diseases; Meningococcal Disease; Human Papillomavirus; Pertussis; Influenza
MeSH terms: Meningococcal Infections; Vaccine-Preventable Diseases
Study type: Interventional

Summary: 
      Although most US adolescents visit their primary care doctor, their immunization rates are
      low. Primary care practices from two networks, one in upstate New York as well as a national
      network of pediatric clinics were surveyed to ask what they thought was the best strategy to
      increase immunization rates. Point-of-care prompts (either by an electronic health record
      message or by a nurse) when an adolescent patient comes in for any type of visit and is due
      for a vaccine was chosen. This study will determine if these prompts will increase
      immunization rates after a 12-month intervention period.
    


Intervention name(s): Point-of-Care Prompt
Intervention type(s): Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: Adolescent Immunization Rates; Provider prompts
A Study to Assess the Interaction Between ASP1707 and Itraconazole in Healthy Female Subjects
Condition: Pharmacokinetics; DDI (Drug-Drug Interaction); Healthy Subjects
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study to explore the effect of multiple oral doses of itraconazole on the
      pharmacokinetics of a single oral dose of ASP1707 in healthy female subjects. This study will
      also evaluate the safety and tolerability of a single oral dose of ASP1707 alone and in
      combination with itraconazole.
    

Detailed description: 
      Subjects will be confined in the clinical unit for up to 15 days.
    

Intervention name(s): ASP1707; itraconazole
Intervention type(s): Drug; Drug
Intervention description(s): oral; oral
Intervention MeSH terms: Itraconazole
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Healthy subjects; ASP1707; Itraconazole
Improvement Effect of Transcranial Direct Current Stimulation (tDCS) Applied During Exercise Training in Stroke Patients With Upper Limb and Hand Motor Function
Condition: Stroke
MeSH terms: Stroke
Study type: Interventional

Summary: 
      The purpose of this study was to improve the effect of Transcranial Direct Current
      Stimulation (tDCS) applied during exercise training in stroke patients with upper limb and
      hand motor function.
    


Intervention name(s): tDCS stimulation with hand task; sham tDCS stimulation with hand task
Intervention type(s): Device; Device
Intervention description(s): 30 minutes of intervention including tDCS stimulation with hand task and fNIRS measurements for 10 days in 4 weeks; 30 minutes of intervention including sham tDCS stimulation with hand task and fNIRS measurements for 10 days in 4 weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
The Effects of a Water Based Exercise Programme and a Land Based Exercise Programme on Women Experiencing Pregnancy Related Pelvic Girdle Pain
Condition: Pregnancy Related; Pelvic Girdle Pain
MeSH terms: Pelvic Girdle Pain
Study type: Interventional

Summary: 
      This study aimed to address whether a water exercise programme improves pain and quality of
      life in pregnant patients with Pelvic Girdle Pain (PGP) compared to a land-based exercise
      programme and the feasibility of undertaking a large-scale research programme.
    

Detailed description: 
      This study aimed to address whether a water exercise programme improves pain and quality of
      life in pregnant patients with Pelvic Girdle Pain (PGP) compared to a land-based exercise
      programme and the feasibility of undertaking a large-scale research programme. Twenty-three
      participants with diagnosed PGP, recruited at St George's Hospital London, were randomised
      into two groups (water or land exercise). Each group received, four, once-weekly exercise
      sessions on land or water. Exercise effects on PGP were measured using a variety of outcome
      measures. Outcomes were assessed at baseline and post four weeks exercise.
    

Intervention name(s): water based exercise; land based exercise; advice
Intervention type(s): Other; Other; Behavioral
Intervention description(s): general advice given to all subjects
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: a randomised controlled feasibility study
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: pregnancy; pelvic girdle pain; hydrotherapy; quality of life; physical therapy
Irreversible Electroporation (NanoKnife) for the Treatment of Pancreatic Adenocarcinoma
Condition: Pancreatic Adenocarcinoma; Interventional Imaging
MeSH terms: Adenocarcinoma
Study type: Interventional

Summary: 
      The aim of the study is to evaluate the use of irreversible electroporation in the treatment
      of locally advanced cancers of the head of pancreas with vascular spread. This technique
      would allow to treat the unresectable part of the tumor to make it more accessible for a
      secondary surgery.
    


Intervention name(s): NanoKnife
Intervention type(s): Device
Intervention description(s): The aim of the treatment is to sourround the tumour with two to six needles and to deliver a very high voltage current (3000 volts in 70 to 80 microseconds pulses) by a generator synchronized with an electrocardiogram.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Locally advanced pancreatic carcinoma; Irreversible electroporation; Interventional radiology
The Long-term Effect on Intestinal Absorption and Safety of Treatment With Glepaglutide in Patients With Short Bowel Syndrome
Condition: Short Bowel Syndrome
MeSH terms: Short Bowel Syndrome; Syndrome
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this trial is to investigate the long-term effect of glepaglutide on the
      intestinal absorption, nutritional status of participants with Short Bowel Syndrome (SBS).
      The trial will also investigate whether glepaglutide is safe during long-term use. All
      participants in the trial will receive glepaglutide injections.

      Participants will have 14 visits with the study doctor. At 2 of these, participants will
      spend 48 hours at the trial site, one visit at the start of the trial and one after 24 weeks
      of treatment with glepaglutide. At all visits, participants will meet with trial staff and
      will have blood tests along with other clinical checks and tests done. Participants will be
      asked about their health and medical history.
    


Intervention name(s): Glepaglutide
Intervention type(s): Drug
Intervention description(s): Glepaglutide will be delivered in a single-use autoinjector.
Other intervention name(s): ZP1848
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Moderate Whole Body Hyperthermia for Patients Undergoing Re-irradiation for Head and Neck Cancer -Influence on the Tumor Microenvironment
Condition: Head and Neck Neoplasms; Recurrence Tumor
MeSH terms: Head and Neck Neoplasms; Recurrence; Hyperthermia
Study type: Interventional
Phase: Phase 1

Summary: 
      The aim of the study is to determine the feasibility and efficacy of moderate weekly whole
      Body hyperthermia Treatment during radiochemotherapy for pre-irradiated locally or regionally
      recurrent head and neck squamous cell carcinomas.

      The Primary aim of the study is feasibility, defined as 80% of patients completing at least
      four applications of hyperthermia.

      Secondary endpoints include an increase of Tumor Perfusion by the use of hyperthermia,
      measured by magnetic resonance Imaging during week two of Treatment and reduction of Tumor
      hypoxia, measured by hypoxia specific Positron emission tomography.
    

Detailed description: 
      Previously irradiated patients with loco/ loco-regional recurrent head and neck squamous cell
      carcinomas usually undergo re-irradiation. However prognosis of these patients is
      unfavourable, especially for non-human papilloma virus associated cancers. Moderate whole
      body hyperthermia will be performed by water-filtered IR-A-radiation using a Heckel-HT3000
      device.

      Preclinical data have indicated that moderate whole body hyperthermia decreases intratumoral
      interstitial fluid pressure and leads to increased perfusion of the tumor. The study
      investigates if this holds also true in patients and leads to a marked decrease of tumor
      hypoxia, measured by 18F-Fluoromisonidazole PET.

      The Primary aim of the study is feasibility, defined as 80% of patients completing at least
      four applications of hyperthermia.

      Secondary endpoints include an increase of Tumor Perfusion by the use of hyperthermia,
      measured by magnetic resonance Imaging during week two of Treatment and reduction of Tumor
      hypoxia, measured by hypoxia specific Positron emission tomography.
    

Intervention name(s): Moderate whole body hyperthermia using water-filtered IR-A-radiation
Intervention type(s): Device
Intervention description(s): four to six applications of whole Body hyperthermia concomitant to radiochemotherapy. Additional measurement of Perfusion and hypoxia by 18F-FMISO hypoxia PET and magnetic resonance Imaging
Other intervention name(s): hypoxia imaging using 18f-fluoromisonidazole before radiochemotherapy and during second week of treatment
Intervention model: Single Group Assignment
Intervention model description: Phase I feasibility study
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: head and neck squamous cell carcinoma; hyperthermia; hypoxia; 18f-fluoromisonidazole; positron emission tomography; FMISO; PET; whole body hyperthermia; local recurrence; lymph node recurrence; radiochemotherapy
A Study to Assess the Safety of Adacel® Vaccine
Condition: Diphtheria; Tetanus; Pertussis
MeSH terms: Whooping Cough; Tetanus; Diphtheria
Study type: Interventional
Phase: Phase 3

Summary: 
      The objective of this study is to describe the safety of Adacel® vaccination in adults
      subjects in Vietnam. This study is conducted in accordance with Vietnamese regulation in
      support to Adacel® registration.

      Primary objective:

      To monitor the adverse effects of the vaccine ADACEL® from day 0 to day 30 after
      immunization.
    

Detailed description: 
      Participants will receive a single dose of Adacel® vaccine and will be followed closely
      during 30 minutes post-vaccination period; a home visit will be made daily during 7 days
      following vaccination in order to monitor safety.

      An additional visit will be conducted 30 days post-vaccination to collect safety information.
    

Intervention name(s): Adacel® (Tetanus, Reduced Diphtheria Toxoid and Acellular Pertussis)
Intervention type(s): Biological
Intervention description(s): 0.5 mL, Intramuscular
Other intervention name(s): Adacel®
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Diphtheria; Tetanus; Pertussis; Adacel®
Biological Effect of Vitamin D in Patients With Urothelial Carcinoma
Condition: Urothelial Carcinoma
MeSH terms: Carcinoma; Carcinoma, Transitional Cell
Study type: Interventional
Phase: Phase 4

Summary: 
      The study population will be 50 women or men diagnosed with urothelial cancer candidates to
      undergo cystectomy as part of their antitumor treatment. The main objective of the study is
      to determine the biological effect of Vitamin D on tumor tissue phenotype; for thus, all
      subjects enrolled in the study will take Vitamin D supplementation 4 weeks prior undergoing
      surgery. Urothelial tissue will be obtained from the surgical procedure and will be studied
      for the Vitamin D effect on cancer cell, compared with that urothelial tissue biopsy obtained
      in the moment of cancer diagnosis.
    

Detailed description: 
      The study will enroll 50 patients (older than 18 and younger than 80 years old), recently
      diagnosed with urothelial cancer and candidates to undergo radical cystectomy or
      nephroureterectomy.

      At the baseline visit, a blood sample will be obtained for 25OH-VitD analysis and all
      subjects will receive first dose of 10.000 IU Vitamin D. Depending of basal plasmatic Vitamin
      D value, patients will be stratified in either 10.000 IU treatment (25OH-VitD ≥ 20 ng/ml) or
      either 50.000 UI treatment dose (25OH-VitD < 20 ng/ml). Treatment will consist of 4 doses
      taken weekly before their scheduled cystectomy. Last study follow-up visit will be 4 weeks
      post-surgery. Urothelial tumor tissue collected on surgery will be used to evaluate the
      expression of tumor differentiation and Vitamin D markers, using genomics and proteomics
      approaches. Blood sample will also be collect throughout the study to evaluate the
      pharmacokinetics of Vitamin D in plasma and the expression of Vitamin D target genes in
      peripheral blood leukocytes.
    

Intervention name(s): Vitamin D
Intervention type(s): Drug
Intervention description(s): First dose of 10.000 IU Vitamin D at baseline visit for all patients; stratification of treatment (10.000 or 50.000 IU Vitamin D) depending base 25(OH)Vitamin D levels. Treatment weekly during 4 weeks before scheduled cystectomy
Other intervention name(s): Cholecalciferol; Colecalciferol
Intervention MeSH terms: Vitamin D; Cholecalciferol
Intervention model: Single Group Assignment
Intervention model description: Treatment stratified with 10.000 IU or 50.000 IU Vitamin D depending of baseline 25(OH)Vitamin D plasmatic levels
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Cancer; Urinary tract; Cystectomy; Vitamin D; Tissue phenotype
A Study to Compare the Efficacy and Safety of Levofloxacin in the Treatment of Children With Community-acquired Pneumonia in the Hospital or Outpatient Setting
Condition: Pneumonia
MeSH terms: Pneumonia
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to determine the safety and efficacy of levofloxacin in the
      treatment of children with community acquired pneumonia.
    

Detailed description: 
      This is a multicenter study to determine the efficacy of levofloxacin compared with the
      "standard of care" (antibiotic medication commonly used for the treatment of infection in
      question) in treating community acquired pneumonia in children aged 6 months to 16 years. The
      study consists of 4 phases: a 1-day screening period when patients will be tested for
      eligibility for the study; 10-day treatment, blood collection, and evaluation period; a
      post-treatment period beginning 1 to 3 days after the last dose of the study medication; and
      a post-study period 10 to 17 days after the last dose of study medication to assess whether
      the patient has been cured of pneumonia. Patients will be divided into 2 groups based upon
      age and then randomly assigned to receive up to 10 days of either levofloxacin or another
      antibiotic. The patients in Group 1 will be randomly assigned to levofloxacin or
      amoxicillin/clavulanate. The patients in Group 2 will be randomly assigned to receive
      levofloxacin or either ceftriaxone plus erythromycin lactobionate or clarithromycin. Safety
      evaluations will include laboratory tests, physical examinations, vital sign measurements,
      and recording of adverse events, including any adverse events affecting muscles or bones.
      Efficacy assessments include whether the patient was cured of pneumonia based on signs and
      symptoms of pneumonia reported before the start of the study. Additionally, at both the
      post-therapy and the post-study visits, responses will be evaluated by patients' signs and
      symptoms and by microscopic examination of the bacteria identified at the start of the study.
      The study hypothesis is that the treatment with levofloxacin will be effective in the
      treatment of children aged 6 months to 16 years with community acquired pneumonia and wil be
      well tolerated by the patients. Levofloxacin 10 mg/kg once or twice daily,
      amoxicillin/clavulanate 22.5 mg/kg twice daily, ceftriaxone 25 mg/kg twice daily plus
      erythromycin lactobionate 10 mg/kg every 6 hours or clarithromycin 7.5 mg/kg twice daily,
      either intravenously or by mouth for up to 10 days.
    

Intervention name(s): Levofloxacin
Intervention type(s): Drug
Intervention MeSH terms: Levofloxacin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Pneumonia; Bacterial pneumonia; Community acquired pneumonia; Lung Inflammation; Quinolones; Levofloxacin; Ceftriaxone; Erythromycin; Clarithromycin