bioihbjkbjnl/mcl2 huggingface dataset:
Cumulative Irritation Patch Test
Condition: Allergy; Irritation; Sensitization
Study type: Observational

Summary: 
      A Cumulative Patch Test with a Challenge Phase is a test devised to ascertain if a chemical
      agent or agents have the potential to cause contact irritation or contact allergy in the
      skin. Allergy is only elicited in immunologically competent individuals who have become
      sensitized through exposure to the chemical agent at a sufficient concentration and for a
      sufficient duration of time.
    


Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        Approximately 240 subjects will be enrolled in the trial so that at least 200 subjects will
        complete the trial. Subjects who meet all of the inclusion criteria and none of the
        exclusion criteria will be eligible to enroll into the trial.
Isthmocele After Two Different Sutures in Cesarean Section
Condition: Cesarean Scar Defect
Study type: Interventional

Summary: 
      Cesarean delivery (CD) rates are rising globally. about 30% of women delivered by CD in 2015
      only in the USA. This increasing CD rate has stimulated an interest in the potential short-
      and long-term morbidity of CD scars. In more than 50% of women with history of CD, a uterine
      scar defect, also called a "isthmocele," defined as a disruption of the myometrium in the CD
      uterine scar, can be observed when examined by gel instillation sonohysterography 6-12 months
      after the CD. Uterine scar defects detected on ultrasound have been associated with prolonged
      menstrual bleeding and postmenstrual spotting, as well as with an increased risk of several
      obstetrical complications in subsequent pregnancies, including uterine dehiscence and/or
      rupture, scar pregnancy and placenta previa and accreta. Another screening method associated
      with uterine scar rupture in women with prior CD is ultrasonographic measurement of the
      thickness of the lower uterine segment, as pioneered by Rozenberg et al. in 1996. A
      meta-analysis by Kok et al. supports the use of the residual myometrial thickness (RMT) for
      predicting uterine rupture during vaginal birth after cesarean. Uterine scar defects have
      been associated with lower RMT.

      A growing body of evidence suggests that the surgical technique for uterine closure
      influences uterine scar healing and the RMT, but there is still no consensus about optimal
      uterine closure and type of suture. It is imperative to have evidence-based guidelines for
      each surgical step before recommending one technique over another.

      The aim of our trial is to evaluate the incidence of cesarean scar defect according to type
      of suture at the time of cesarean
    


Intervention name(s): monofilament
Intervention type(s): Procedure
Intervention description(s): In the intervention group,monofilament absorbable suture,will be used.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Safety, Tolerability, Pharmacokinetics and Effects on Transcranial Magnetic Stimulation of Oral Doses of XEN1101
Condition: Healthy Male Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The XEN1101 Phase 1 clinical trial is a randomized, double-blind, placebo-controlled study
      that will eventuate the safety, tolerability, pharmacokinetics (PK) and effects on
      transcranial magnetic stimulation (TMS) of oral doses of XEN1101 in healthy male subjects.The
      TMS procedure is designed to demonstrate delivery of XEN1101 into the central nervous system
      and to observe a change in cortical excitability as measured by EEG and/or EMG activity. It
      is estimated there will be approximately 15 subjects in the planned study.
    


Intervention name(s): XPF-008; Microcrystalline Cellulose
Intervention type(s): Drug; Drug
Intervention description(s): Capsule filled with XEN1101; Placebo capsule
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Transcranial magnetic stimulation
Safety and Immunogenicity of Formulations of Dengue Vaccines in Healthy Flavivirus-Naïve Adults
Condition: Dengue Virus; Dengue Fever; Dengue Hemorrhagic Fever; Dengue Diseases
MeSH terms: Dengue; Hemorrhagic Fevers, Viral; Severe Dengue; Fever; Hyperthermia
Study type: Interventional
Phase: Phase 2

Summary: 
      This is part of an ongoing effort to develop a satisfactory dengue vaccine:

      Primary objective:

      To describe the safety after each vaccination with bivalent and tetravalent formulations of
      dengue vaccine candidates.

      To describe the immune response after each vaccination of dengue vaccine.
    

Detailed description: 
      Subjects will be randomized to five groups to receive assigned vaccines and followed up for
      12 months.
    

Intervention name(s): Bivalent CYD-1,3 Dengue (Vero) + Bivalent CYD-2,4 Dengue (Vero); Bivalent CYD-1,3 Dengue (Vero) + Bivalent CYD-2,4 Dengue (Vero); Tetravalent blending VDV-2/CYD-1,3,4 Dengue (Vero); Tetravalent CYD-1,2,3,4 Dengue (Vero); JE-VAX®: Japanese encephalitis virus vaccine inactivated + Tetravalent CYD-1,2,3,4 Dengue (Vero)
Intervention type(s): Biological; Biological; Biological; Biological; Biological
Intervention description(s): 0.5 mL, Subcutaneous (SC) (CYD-1,3 Day 0; CYD-2,4 Day 105); 0.5 mL, Subcutaneous (SC) (CYD-1,3 + CYD-2,4 on Day 0 and Day 105); 0.5 mL, Subcutaneous (SC) (Day 0 and Day 105); 0.5 mL, Subcutaneous (SC) (Day 0 and Day 105); 0.5 mL, Subcutaneous (SC) (JE-VAX® Day 0 + Tetravalent CYD-1,2,3,4 on Day 105)
Other intervention name(s): JE-VAX®
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Dengue virus; Dengue fever; Dengue hemorrhagic fever; Dengue diseases
Malaria Clinical Trials Center General Screening
Condition: Malaria
MeSH terms: Malaria
Study type: Observational [Patient Registry]

Summary: 
      The purpose of this study is to identify and screen potential subjects for preliminary
      eligibility to participate in a malaria related clinical trial conducted at the Seattle
      Malaria Clinical Trials Center (Seattle MCTC) or one of our partnering sites.
    

Detailed description: 
      This is a continuous study enrolling approximately 350 participants per year to establish
      preliminary eligibility for participation in ongoing or future Seattle Malaria Clinical
      Trials Center (Seattle MCTC) clinical research studies. Data collected may be used to support
      preliminary eligibility for a current or future Seattle MCTC clinical research study.

      In order to maximize efficiency of the screening process potential participants who contact
      the site will be pre-screened using an IRB-approved screening form.

      Potential participants who contact the site may be asked to come in for an in-person
      screening visit. They will be given a consent form to read and sign if they should choose to
      participate in the screening process. If they have any questions during this process research
      staff will be available. This visit includes an in-depth medical history review, travel
      history, physical exam, blood draw, electrocardiogram test (ECG), and a urine test.

      The Seattle Malaria Clinical Trials Center (Seattle MCTC) is conducting research to combat
      malaria. Malaria is a disease that is transmitted to humans by the bite of an infected
      mosquito and affects millions of people worldwide. Malaria can cause a wide range of medical
      problems, and may even result in death if the infection is not treated. Currently there are
      many medications, preventative measures and malaria vaccines being developed to fight malaria
      that will need to be tested before they can be made available to the general public. The
      Seattle MCTC is conducting clinical research studies for this purpose and is in need of
      healthy adult volunteers to take part in upcoming studies.
    

Observational model: Other
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Men and non-pregnant women who are in general good health.
      
Keywords: Malaria; Plasmodium; Plasmodium falciparum; Clinical Trials; Vaccine Study; Drug Study; Malaria Clinical Trials Center; Seattle BioMed; Center for Infectious Disease Research
Pilot Study of PUFA-optimized RUTF for Severe Acute Malnutrition
Condition: Kwashiorkor; Marasmus
MeSH terms: Malnutrition; Severe Acute Malnutrition; Kwashiorkor; Protein-Energy Malnutrition
Study type: Interventional

Summary: 
      To test whether a ready-to-use therapeutic food (RUTF) enriched with polyunsaturated fatty
      acids (RUTF-P) is as effective for the treatment of severe acute malnutrition (SAM) as
      standard RUTF.
    

Detailed description: 
      Since 2007, RUTF has been the recommended treatment for SAM. RUTF is not conducive to the
      growth of bacteria because of the low moisture content, does not require cooking, and has led
      to greater recovery rates than liquid milk formulations in direct comparisons. One expected
      benefit of the RUTF-P is improved outcomes due to the higher levels of essential fatty acids.

      The essential fatty acid profile (i.e., the level of omega-3 and omega-6 fatty acids) of
      RUTF-P may have important implications for cognitive development of children, especially
      infants, with SAM who consume these foods as their sole dietary source for several weeks. In
      particular, an excess of omega-6 fatty acids (from sources such as peanut and corn oil) and a
      minimum of omega-3 fatty acids (from sources like flax) may fail to support optimal cognitive
      development and neural function.

      In this prospective, double-blinded, randomized controlled clinical effectiveness trial, we
      will compare two RUTF products in the treatment of SAM to test the effects of the two
      different RUTF products on essential fatty acid status.
    

Intervention name(s): RUTF; RUTF-P; Amoxicillin
Intervention type(s): Dietary Supplement; Dietary Supplement; Drug
Other intervention name(s): ready-to-use therapeutic food
Intervention MeSH terms: Amoxicillin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: severe acute malnutrition; polyunsaturated fatty acids; ready-to-use therapeutic food
Grass Observational Study
Condition: Grass Allergy; Rhinoconjunctivitis
MeSH terms: Hypersensitivity
Study type: Observational

Summary: 
      Grass pollen allergens are universally recognised as a major cause of allergic diseases in
      humans, including asthma, allergic rhinitis, conjunctivitis and dermatitis.

      The purpose of the current study is to evaluate allergy symptoms and allergy medication in
      subjects with grass-related rhinoconjunctivitis.
    


Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Subjects with a history of Grass induced Rhinoconjunctivitis
PDE5 Inhibition for Obesity-Related Cardiometabolic Dysfunction
Condition: Healthy; Obese
MeSH terms: Obesity
Study type: Interventional
Phase: Phase 2

Summary: 
      Obesity and its adverse cardiometabolic consequences are major public health problems.
      Several features of obesity contribute to the associated cardiovascular risk and are
      potential targets for intervention. These include insulin resistance and beta cell
      dysfunction, reduced metabolic rate, and impaired aerobic capacity.The purpose of this study
      is to examine if the phosphodiesterase type 5A inhibitor tadalafil improves cardiometabolic
      health in individuals who are obese and insulin resistant.
    

Detailed description: 
      Obesity is a risk factor for nearly all cardiovascular (CV) disease including coronary artery
      disease, hypertension, and heart failure. Increased CV risk in obese individuals appears to
      depend largely on the degree of metabolic dysregulation and metabolic risk factors (glucose
      intolerance, dyslipidemia, etc.). Notably, interventions that improve insulin sensitivity and
      cardiorespiratory fitness can reduce CV risk in obese individuals, even in the absence of
      weight loss.

      The cyclic guanylate monophosphate pathway (cGMP) is involved in energy homeostasis and
      systemic metabolism. Multiple lines of evidence suggest that increasing cGMP activity is
      beneficial from a metabolic standpoint. Tadalafil is a clinically-available drug that
      inhibits the enzyme that breaks down cGMP.

      The study investigators hypothesize that chronic PDE5 inhibition in obese, insulin-resistant
      adults will improve cardiometabolic health.

      Aim 1: To examine the effect of PDE5 inhibition on energy expenditure. Aim 2: To examine the
      effect of PDE5 inhibition on insulin sensitivity and secretion.

      Aim 3: To examine the effect of PDE5 inhibition on cGMP tone and circulating mediators of
      cardiometabolic risk.
    

Intervention name(s): Tadalafil; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Tadalafil is an FDA approved, clinically-available drug that inhibits the enzyme phosphodiesterase type 5A (PDE5). Subjects who are randomized to this arm will be provided with 20mg of Tadalafil to take every day for 12 weeks, beginning at their baseline visit.; 100 patients will be randomized to receive a placebo pill. Subjects in this arm will be provided with 20mg Placebo to take every day for 12 weeks, beginning at their baseline visit.
Other intervention name(s): CIALIS
Intervention MeSH terms: Tadalafil
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Effects of Antiviral Therapy on Patients With HBV-related HCC
Condition: Hepatocellular Carcinoma; Hepatitis B Virus; Survival
MeSH terms: Hepatitis A; Hepatitis B; Carcinoma; Carcinoma, Hepatocellular; Hepatitis
Study type: Observational

Summary: 
      Based on the follow-up data of patients who underwent hepatectomy for HBV-related HCC at the
      First Affiliated Hospital of Xi'an Jiaotong University. patients who met the enrollment
      criteria were screened for tumor recurrence and survival for statistical analysis to
      understand the prognosis of patients and analyze the risk factors affecting their prognosis.
    

Detailed description: 
      A retrospective study of patients who underwent hepatectomy for HBV-related HCC at the First
      Affiliated Hospital of Xi'an Jiaotong University from January 2016 to June 2019 was
      conducted. The clinical data of patients, including demographic features, perioperative
      laboratory values, surgical information, and pathological data, were collected from the
      official database for patients' data gathering, also, Based on the follow-up data of patients
      who met the enrollment criteria were screened for tumor recurrence and survival for
      statistical analysis to understand the prognosis of patients and analyze the risk factors
      affecting their prognosis.
    

Intervention name(s): Medication history
Intervention type(s): Other
Intervention description(s): The study was retrospective and did not involve the application of interventions
Observational model: Case-Control
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Adult patients (age 18 or older) who underwent hepatectomy between January 1st, 2016, and
        June 30st, 2019, were retrospectively identified using the database for clinical data in
        the First Affiliated Hospital of Xi'an Jiaotong University
      
Keywords: Hepatitis B virus; Antiviral therapy; Hepatectomy
A Non Interventional Study to Investigating the Ratio of Mis-diagnosed Bipolar Symptoms in Patient With Major Depressive Disorder (MDD)
Condition: Major Depressive Disorder; MDD
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Study type: Observational

Summary: 
      The study will only detect hypomanic symptoms in treatment resistant MDD patients by mean of
      HCL-32 administration. Further re-evaluation of MDD diagnosis is not a direct aim of the
      study. No efficacy and tolerability of pharmacological treatments will be assessed. Patients
      matching inclusion and exclusion criteria will be enrolled consecutively; each investigator
      will include the first 10 to 40 patients that will be visited as treatment resistant MDD.
    


Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients with treatment resistant major depressive disorder will be evaluated in order to
        assess the presence of hypomanic symptoms as cause of resistance.
      
Keywords: Major Depressive Disorder; MDD
Mindfulness-Music Intervention for Adolescents and Young Adults With Cancer
Condition: Anxiety; Oncology; Stress
MeSH terms: Neoplasms; Anxiety Disorders
Study type: Interventional

Summary: 
      This study is evaluating how well a music therapy program works to improve anxiety and stress
      in adolescents and young adults receiving cancer treatment.
    

Detailed description: 
      This research study will test how well a music therapy program works to improve anxiety and
      stress in adolescents and young adults receiving cancer treatment. The program is designed to
      incorporate music-based meditation practices and music making activities (e.g., guitar,
      drums) to help promote relaxation during cancer treatment.
    

Intervention name(s): Music-based meditation
Intervention type(s): Behavioral
Intervention description(s): The program is designed to incorporate music-based meditation practices and music making activities (e.g., guitar, drums) to help promote relaxation during cancer treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Anxiety; Music Therapy; Oncology; Adolescent and Young Adults
Safety and Immunogenicity of Vi-CRM197 Vaccine Against S. Typhi in Children, Older Infants and Infants
Condition: Typhoid Fever
MeSH terms: Typhoid Fever
Study type: Interventional
Phase: Phase 2

Summary: 
      This phase 2 trial is aimed to obtain information on the safety and immunogenicity of the
      Vi-CRM197 in children and infants from various age groups in the Philippines where Typhoid
      Fever is highly endemic and an efficacious vaccine against this disease is very much needed.
    


Intervention name(s): Vi-CRM197 vaccine; Pneumococcal conjugate vaccine; Vi Polysaccharide (PS) vaccine
Intervention type(s): Biological; Biological; Biological
Other intervention name(s): Prevenar 13; Typherix
Intervention MeSH terms: Vaccines; Heptavalent Pneumococcal Conjugate Vaccine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Ridge Splitting With Simultaneous Implant Placement Using i-PRF
Condition: Ridge Splitting; i-PRF; Dental Implant
Study type: Interventional

Summary: 
      Sohn introduced the concept of sticky bone in which i-PRF is mixed with the granules of bone
      graft, leading to fabrication of growth factors-enriched bone graft matrix using autologous
      fibrin glue. This minimizes bone loss and accelerates tissue healing during healing period.
      The present study was conducted to evaluate the clinical and radiographic outcomes following
      the application of the alveolar ridge splitting in combination with the use of guided bone
      regeneration (GBR) with or without i-PRF (sticky bone), associated with immediate implant
      placement in patients with horizontally atrophic jaw bones.
    


Intervention name(s): Immediate implant placement and alveolar ridge splitting with GBR and i-PRF; Immediate implant placement and alveolar ridge splitting with GBR
Intervention type(s): Procedure; Procedure
Intervention description(s): Implant insertion and GBR for augmentation of the gap between buccal and lingual plate using bone graft mixed with i-PRF; Implant insertion and GBR for augmentation of the gap between buccal and lingual plate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Enhanced Recovery After Laparoscopic Sleeve Gastrectomy - a Randomised Controlled Trial
Condition: Morbid Obesity
MeSH terms: Obesity, Morbid
Study type: Interventional

Summary: 
      The investigators wish to standardise and optimise perioperative care for consecutive
      patients undergoing laparoscopic sleeve gastrectomy for weight loss. The investigators will
      compare patients under a standardised perioperative care program to patients who undergo
      routine perioperative in our hospital and determine whether patients who had optimised
      perioperative care went home earlier and had fewer complications.
    


Intervention name(s): Enhanced Recovery After Surgey for Sleeve Gastrectomy
Intervention type(s): Other
Intervention description(s): Intraoperative:
Pre-op carbohydrate loading
No pre-op GIK while NBM
Pre-medication
Dexamethasone 4mg as antiemetic, IV Paracetamol (first dose) Parecoxib 40mg
Ondansetron regularly for first 48 hours and Cyclizine, Droperidol or Scopaderm as rescue antiemetics
Fluid restriction
Standardised method of anaesthesia
Give 40ml 0.5% bupivacaine with adrenaline administered prior to placement of laparoscopic port sites
10ml 0.75% ropivacaine diluted to 50ml with 0.9% normal saline solution administered to surgical site prior to procedure
Postoperative:
Rescue PCA for up to 12 hours. Oxynorm 5mg for rescue pain. Oxycontin 20mg bd/prn postoperatively
Maintenance IV fluids (60ml/hr plasmalyte to be stopped 0800 day 1 post op). Clear oral fluids 2 hours post op. Bariatric free oral fluids morning of day 1
Post operative oxygenation
Incentive spirometry
Drains (e.g. IDC) removed in recovery
Full mobilisation 4-8 hours post op)
Early Follow up
Other intervention name(s): ERAS for sleeve gastrectomy; Fast-Track for sleeve gastrectomy
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Perioperative care; Fast-track; Enhanced Recovery After Surgery; ERAS; Obesity; Bariatric surgery; Laparoscopic Sleeve Gastrectomy
Study of Skin Parameters in the PROOF Cohort
Condition: Skin Aging
Study type: Observational

Summary: 
      This study aims to evaluate skin aging of an homogeneous population of 77 years old patient
      selected among the PROOF cohort who has been continuously investigated by cardiological
      examination.

      Skin aging will be explored by macroscopic and microscopic evaluation. In particular, skin
      aging will be measured by an index of clinical aging (SCINEXA) and other complementary
      measures such as facial photos, standard and High Definition dermoscopy, elastography,
      sebumetry, in vivo and ex vivo confocal microscopy, and classical histological examinations.
    


Intervention name(s): Dermatological clinical examination; Biopsy; Confocal microscopy in vivo
Intervention type(s): Other; Other; Other
Intervention description(s): Clinical pictures, Dermatoscopy, Elastography, Sebumetry; Skin biopsy for examinations by confocal microscopy ex vivo and histopathology; Examination by confocal microscopy in vivo
Intervention MeSH terms: Dermatologic Agents
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        PROOF cohort (NCT00759304)
      
Biospecimen description: 
      Skin
    
Keywords: Skin Surface Microscopy; Skin Aging; PROOF