bioihbjkbjnl/mcl2 huggingface dataset:
Efficacy and Safety Study of Aripiprazole to Treat Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 2

Summary: 
      This study design is subject to relevant SFDA regulations about clinical trials. Patients
      will be screened for inclusion into the study at the initial visit(240 patients to be
      recruited) and then undergo a minimum of 3-7 day's placebo washout period(placebo wash out is
      to eliminate the effect of prior antipsychotic medication with tablets without any active
      ingredients)(patients without prior antipsychotic medication are exempt from the washout
      phase). After screening and washout period, eligible patients will be randomly assigned to
      the two treatment group, Aripiprazole or Risperidone, for 6 week's treatment. Patients will
      be hospitalized for the entire duration of the study. Patients' condition will be assessed
      weekly.
    


Intervention name(s): Aripiprazole tablet, 5-30mg/day, oral, 6 weeks; Risperidone tablet, 1-6mg/day, oral, 6 weeks
Intervention type(s): Drug; Drug
Intervention MeSH terms: Risperidone; Aripiprazole
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Aripiprazole; Schizophrenia; Clinical trial; Risperidone
Observational Study of Vision Improvement in Late Stage Dry AMD Patients
Condition: Dry Age-related Macular Degeneration
MeSH terms: Macular Degeneration
Study type: Observational

Summary: 
      The purpose of this study is to assess the vision improvement achieved by patients with late
      stage dry age-related macular degeneration who received corneal treatments by a low vision
      aid device.
    

Detailed description: 
      The purpose of this study is to assess the vision improvement achieved by patients with late
      stage dry age-related macular degeneration who received corneal treatments by a low vision
      aid device. Patient records for patients with at least 12 months follow-up will be analyzed
      to determine measures of vision improvement including best spectacle-corrected distance and
      near visual acuity. Analyses will include descriptive statistics and correlation between
      outcomes and baseline characteristics.
    

Intervention name(s): Corneal treatment by a low vision aid device
Intervention type(s): Device
Intervention description(s): Near infrared light is used to irradiate the cornea to change the modulus of small volumes of anterior stroma. The change of modulus produces a change of corneal stiffness and shape that modifies the distribution of light onto the retina. Light rays are redirected from dysfunctional areas of the retina that have been damaged by age-related macular degeneration (AMD) to functional areas of the retina, thereby improving patient vision.
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Patients with vision impairment due to late stage dry age-related macular degeneration.
      
Keywords: Dry AMD
Minocycline Bioequivalence Study
Condition: Skin Diseases
MeSH terms: Skin Diseases
Study type: Interventional
Phase: Phase 1

Summary: 
      This study compared the bioavailability of two formulations 100 mg (one capsule or other
      respectively) of each one of the products, of Minocycline, under fasting conditions, in
      healthy Mexican volunteers of both sexes. The single dose study under fasting (10 hours prior
      to study) conditions, cross, with two treatments, two periods, two sequences (2x2) randomized
      sequence, balanced, and with a washout period of at least 7 days between each dose, in 24
      healthy volunteers.
    


Intervention name(s): Minocycline
Intervention type(s): Drug
Intervention description(s): minocycline hydrochloride capsules in microgranules equivalent to 100 mg of minocycline
Intervention MeSH terms: Minocycline
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: dermatitis; Minocycline; bioavailability
IM and Oral in Acute Exacerbation of Schizophrenia (BIZET Study)
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 3

Summary: 
      To evaluate efficacy and tolerability of Ziprasidone IM and oral in agitated patients with
      acute exacerbation of schizophrenia
    


Intervention name(s): Ziprasidone
Intervention type(s): Drug
Intervention MeSH terms: Ziprasidone
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Genetic Variation in Gonadotropin and Gonadotropin Receptor Genes and Suboptimal Response
Condition: Fertility Disorders
Study type: Observational

Summary: 
      To evaluate the difference in the prevalence of the main FSHR polymorphism (ASN680Ser), as
      well as other, less studied, gonadotropin polymorphisms between ovarian response groups,
      following ovarian stimulation
    


Intervention name(s): blood sample
Intervention type(s): Other
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Infertile women undergoing ovarian stimulation
Docetaxel, Capecitabine, and Cisplatin in Treating Patients With Advanced Solid Tumors
Condition: Unspecified Adult Solid Tumor, Protocol Specific
MeSH terms: Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      RATIONALE: Drugs used in chemotherapy, such as docetaxel, capecitabine, and cisplatin, work
      in different ways to stop tumor cells from dividing so they stop growing or die. Giving more
      than one chemotherapy drug may kill more tumor cells.

      PURPOSE: This phase I trial is studying the side effects and best dose of docetaxel,
      capecitabine, and cisplatin in treating patients with metastatic or unresectable solid
      tumors.
    

Detailed description: 
      OBJECTIVES:

      Primary

        -  Determine the maximum tolerated dose of docetaxel, cisplatin, and capecitabine in
           patients with advanced solid tumors.

        -  Determine the dose-limiting toxicity and recommended phase II dose of this regimen in
           these patients.

      Secondary

        -  Determine the non-dose-limiting toxic effects associated with this regimen in these
           patients.

        -  Determine the pharmacokinetics of this regimen in these patients.

        -  Determine any clinical activity of this regimen in these patients.

      OUTLINE: This is a dose-escalation study.

      Patients receive docetaxel IV over 30 minutes and cisplatin IV over 30 minutes on days 1 and
      8 and oral capecitabine twice daily on days 1-14. Courses repeat every 21 days in the absence
      of disease progression or unacceptable toxicity.

      Cohorts of 3-6 patients receive escalating doses of docetaxel, cisplatin, and capecitabine
      until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose
      preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. At least
      6 patients receive treatment at the MTD.

      PROJECTED ACCRUAL: A minimum of 21 patients will be accrued for this study within 1.5 years.
    

Intervention name(s): capecitabine; cisplatin; docetaxel
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Oral; IV; IV
Intervention MeSH terms: Docetaxel; Capecitabine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: unspecified adult solid tumor, protocol specific
Helping Parents to Decide Whether They Want to be With Their Child During Anesthesia Induction
Condition: Pre-operative Anxiety
Study type: Interventional

Summary: 
      Children are distressed at anesthesia induction and this distress can result in maladaptive
      recovery outcomes. Having parents be present at anesthesia induction (PPIA) has been
      suggested as a potential intervention to decrease children's distress, and this intervention
      is widely favored by parents. However, to date, PPIA has not been found to be effective in
      reducing children's anxiety. The lack of efficacy may be attributable to the fact that
      parents have generally not been prepared for PPIA. The one study that prepared parents (as
      part of a larger preoperative preparation program) found that PPIA with preparation was
      superior to PPIA as previously studied (without preparation). Unfortunately, this program is
      resource intensive and therefore is not clinically feasible. This study will compare PPIA
      with a clinically feasible preparation program to PPIA with standard care (minimal
      preparation). Should our intervention show evidence of efficacy, the investigators will have
      designed a program that is easily translatable to everyday clinical practice. This will, in
      turn, reduce children's anxiety, improve postoperative outcomes and increase parental
      satisfaction.
    


Intervention name(s): Parental presence decision tool; Standard preparation
Intervention type(s): Behavioral; Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: Pediatric anesthesia; Pre-operative anxiety; parental presence; children; elective surgical procedures; mask induction
Use of 2-octyl-cyanoacrylate Together With a Self-adhering Mesh
Condition: Surgical Wound Dehiscence; Cutis Laxa; Wound of Skin
MeSH terms: Cutis Laxa; Surgical Wound Dehiscence; Wounds and Injuries; Surgical Wound
Study type: Observational

Summary: 
      The investigators prospectively studied the results of wound closure after abdominoplasty
      with randomized use of PrineoTM and conventional suturing to assess the possible difference
      in outcome between these two methods.Follow-up visits to the outpatient clinic were scheduled
      at 2 weeks, 6 months and 12 months after surgery. A panel consisting of three plastic
      surgeons and three plastic surgery residents assessed the wound and scar appearance during
      the three follow-up visits.
    

Detailed description: 
      Abdominoplasty is one of the most commonly performed procedures in plastic surgery. The
      appearance of the scar is a major factor contributing to the aesthetic outcome of the
      procedure and depends largely on the technique of wound closure. The new PrineoTM wound
      closure system was introduced to combine the effectiveness of 2-octyl-cyanoacrylate
      (Dermabond TM) together with a self-adhering mesh.Fifty-two women and 8 men aged between 21
      and 65 years scheduled for abdominoplasty were included in the study. Total operating time
      after abdominoplasty between the traditional wound closure technique and the PrineoTM-type
      wound closure technique was compared. Two weeks postoperatively, the wounds were examined and
      graded according to the Hollander Cosmesis Scale. At 6- and 12-month follow-up, the aesthetic
      outcome of the abdominal scar was evaluated with the Vancouver Scar Scale. Twelve months
      postoperatively, the patients were further asked to score their part of the Patient Scar
      Assessment Scale.There was a statistically significant shorter mean of total operating time
      for the new skin closure system compared with intradermal sutures. The Hollander Cosmesis
      Scale indicated a significantly more favourable overall result with PrineoTM at 2 weeks after
      surgery. The Vancouver Scar Scale demonstrated a better cosmetic outcome in favour of
      PrineoTM 6 and 12 months after surgery The Patient Scar Assessment Scale scores 12 months
      after surgery indicated that the patients noted significantly less pain, thickness and
      irregularity with PrineoTM.Based on our results, we conclude that PrineoTM is a safe and
      effective substitute for superficial skin closure, with good cosmetic results and no increase
      in wound complications. The use of PrineoTM decreases operative times and costs and enhances
      patients' postoperative comfort.
    

Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        primary care clinic
      
Keywords: abdominoplasty,; skin closure, dressings
Omega-3 Fatty Acid in Reducing Cancer-Related Fatigue in Breast Cancer Survivors
Condition: Breast Carcinoma; Cancer; Fatigue
MeSH terms: Breast Neoplasms; Fatigue
Study type: Interventional

Summary: 
      This randomized pilot clinical trial studies omega-3 fatty acid in reducing cancer-related
      fatigue in breast cancer survivors. Supplementation with omega-3 fatty acid may help reduce
      cancer-related fatigue in breast cancer survivors.
    

Detailed description: 
      PRIMARY OBJECTIVE:

      I. To collect preliminary statistical data (mean changes and standard deviations) on two
      omega-3 supplementation (omega-3 fatty acid) regimens (1.65 g/day and 3.3 g/day) compared to
      placebo for reducing cancer-related fatigue (CRF) in fatigued breast cancer survivors.

      OUTLINE: Patients are randomized to 1 of 3 arms.

      ARM I: Patients receive low-dose omega-3 fatty acid supplementation orally (PO) twice daily
      (BID) and placebo PO BID for 6 weeks.

      ARM II: Patients receive high-dose omega-3 fatty acid supplementation PO BID for 6 weeks.

      ARM III: Patients receive placebo PO BID for 6 weeks.
    

Intervention name(s): Omega-3 Fatty Acid; Placebo; Questionnaire Administration; Laboratory Biomarker Analysis
Intervention type(s): Dietary Supplement; Other; Other; Other
Intervention description(s): Given PO; Given PO; Ancillary studies; Correlative studies
Other intervention name(s): O3FA; Omega-3 Fatty Acids; Omega-3 PUFA; PLCB
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Supportive Care
Keywords: Cancer Survivor
Trial to Investigate Viral Shedding in Healthy Children Vaccinated With Vaccine Virus Liquid (CAIV-T)
Condition: Influenza
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 2

Summary: 
      The primary objective of this study was to determine the proportion of subjects, seronegative
      to all three strains of influenza, as defined by a serum hemagglutination inhibition
      antibodies (HAI) antibody titer of <1:10, who shed each vaccine virus strain following a
      single dose of CAIV-T.
    


Intervention name(s): CAIV-T, Liquid
Intervention type(s): Biological
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double
Primary purpose: Treatment
Dose Escalation Study With Cabazitaxel in Combination With Daily Prednisolone in Patients With Hormone Refractory Prostate Cancer
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      Primary Objective:

        -  To assess the tolerability at global doses

      Secondary Objectives:

        -  Safety

        -  Pharmacokinetics

        -  Efficacy
    

Detailed description: 
      The duration of screening within 28 days, treatment 3 weeks/cycle and follow-up 30 days after
      the last cabazitaxel administration.
    

Intervention name(s): Cabazitaxel (XRP6258); prednisolone
Intervention type(s): Drug; Drug
Intervention description(s): Pharmaceutical form:solution
Route of administration: intravenous; Pharmaceutical form:tablet
Route of administration: oral
Intervention MeSH terms: Prednisolone
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
ctDNA Dynamic Monitoring and Its Role of Prognosis in Stage II to IIIA NSCLC by NGS
Condition: NSCLC
MeSH terms: Carcinoma, Non-Small-Cell Lung
Study type: Observational

Summary: 
      The second generation of high-throughput gene sequencing (NGS) is an important means of
      detecting the tumor DNA and circulating tumor DNA (ctDNA), which can detect trace ctDNA from
      smaller plasma samples. This project is chiefly to study the role of ctDNA dynamic monitoring
      of stage IIA to IIIA NSCLC by NGS technique to verify the prognostic predictive effect of
      ctDNA. And the investigators also wander the concordance of lung cancer related genes
      mutation map and frequency between primary tumors and infiltrated regional lymph nodes.
    

Detailed description: 
      In the NGS era, ctDNA detection can truly reflect the real tumor tissue gene mutation map and
      frequency. It becomes the evaluation of therapeutic effect and the important monitoring
      indicators of clinical follow-up after surgery and adjuvant chemotherapy. The second
      generation of high-throughput gene sequencing (NGS) is an important means of detecting ctDNA,
      which can detect trace ctDNA from smaller plasma samples. The DNA dynamic monitoring of stage
      II to IIIA non-small cell lung cancer (NSCLC) was performed by the NGS technique to verify
      prognostic predictive effect of ctDNA in stage IIA to IIIA NSCLC patients after operation.
      The lung cancer related genes mutation map and frequency between primary tumors and
      infiltrated regional lymph nodes seems not exactly consistent. In this study, the
      investigators will compare the lung cancer related genes mutation map and frequency between
      primary tumors, bloodstream and infiltrated lymph node by the NGS technique.
    

Intervention name(s): the ctDNA dynamic monitoring
Intervention type(s): Diagnostic Test
Intervention description(s): To detect ctDNA in patients using the second generation of high-throughput gene sequencing (NGS)
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients With Stage IIA to IIIA Non-small Cell Lung Cancer (NSCLC) with R0 resection.
      
Biospecimen description: 
      Tumor tissue, lymph node tissue, blood.
    
Keywords: Non-Small Cell Lung Cancer; stage II to IIIA; circulating tumor DNA; The next generation of high-throughput gene sequencing
Efficacy and Safety of Meteospasmyl® in Irritable Bowel Syndrome
Condition: Irritable Bowel Syndrome
MeSH terms: Irritable Bowel Syndrome; Syndrome
Study type: Interventional
Phase: Phase 4

Summary: 
      To assess the effectiveness of alverine citrate and simeticone on IBS symptoms according to
      the latest recommended design
    


Intervention name(s): alverine citrate and simeticone; placebo
Intervention type(s): Drug; Drug
Other intervention name(s): Meteospasmyl®
Intervention MeSH terms: Mebeverine; Alverine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Automated Overnight Closed-loop Glucose Control in Young People With Type 1 Diabetes
Condition: Type 1 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional

Summary: 
      Children and adolescents with type 1 diabetes need regular insulin injections or continuous
      insulin delivery with an insulin pump in order to keep blood sugar levels normal. The
      investigators know that keeping blood sugars in the normal range can prevent long term
      diabetes complications involving the eyes, kidneys and heart. However, achieving treatment
      goals can be very difficult as the tighter the investigators try to control blood glucose
      levels, the greater the risk for the young person to develop symptoms and signs of low
      glucose levels (hypoglycaemia). This is a particular problem at night. One solution is to
      develop a system whereby the amount of insulin injected is very closely matched to the blood
      sugar levels on a continuous basis. In a closed loop system, for example, a continuous
      glucose sensor communicates with a computer algorithm which drives an insulin pump. The
      investigators have been developing such a system in Cambridge over the last year with funding
      from the Juvenile Diabetes Research Foundation. The investigators have found that this system
      is very effective at preventing hypoglycaemia in young people with diabetes.

      Until now the information from the sensor has been entered manually into the computer and the
      pump settings have also been changed manually. The investigators now need to move onto the
      next step which is to fully automate the system. The studies will be done in a clinical
      research facility. The investigators will study the young people on two nights in order to
      find out if the closed loop system started early in the evening is as effective as when it is
      started later before sleep. 12 young people will be recruited from diabetes clinics in the
      East Anglia region. The studies will provide further important information concerning the
      safety, efficacy and utility of closed loop systems.
    


Intervention name(s): Automated closed-loop insulin delivery
Intervention type(s): Other
Intervention description(s): Insulin infusion rates via the insulin pump will be dictated by a computer-based control algorithm according to the CGM glucose readings and automatically adjusted on the pump.
Other intervention name(s): Automated CL
Intervention MeSH terms: Insulin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: T1D, closed-loop systems, overnight hypoglycaemia
Macro- and Microvascular Response to Cocoa Flavanols in Healthy and Type 2 Diabetes
Condition: Microangiopathy, Diabetic; Polyphenol; Optical Tomography; Vascular Endothelium; Arterial Stiffness; Healthy Participants
MeSH terms: Diabetic Angiopathies
Study type: Interventional

Summary: 
      The greatest challenge in our ageing society are cardiovascular diseases such as stroke,
      heart attack, peripheral artery disease of the legs with non-healing wounds (ulcers), or
      diabetes. Specific diets with high polyphenol content are associated with lower incidence of
      cardiovascular disease and can improve macrovascular function when consumed acutely and
      chronically. Which role the smallest blood vessels (microcirculation) play in this and if the
      microcirculation responds to therapies is not well understood. One reason for this is that no
      generally available medical instrument has the resolution to study the microcirculation. The
      recently developed optical coherence tomography angiography (OCTA), currently mainly used by
      eye doctors, is able to visualise the microcirculation.

      The current randomised controlled cross-over proof-of-concept study will test the acute
      effect of a cocoa flavanol intervention on cutaneous microvascular structure and function of
      hands and feet together with macrovascular function of upper and lower extremities in healthy
      and type 2 diabetes participants. It is the hypothesis that cocoa flavanol intervention as
      compared to placebo can acutely increase microvascular vasodilation and macrovascular
      endothelial function in arms and legs together with arterial stiffness in both healthy and
      type 2 diabetes participants.
    


Intervention name(s): Cocoa flavanol; Placebo
Intervention type(s): Dietary Supplement; Other
Intervention description(s): Commercially available Cocoa Via Brand capsules containing 1350 mg cocoa flavanols (6 capsules); Capsules identical to ccocoa flavanol capsules filled with calorically matched brown sugar (6 capsules)
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: 2 group (healthy and type 2 diabetes) randomised controlled cross-over (2-period, 2-sequence) study
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Basic Science