bioihbjkbjnl/mcl2 huggingface dataset:
The Dietary Education Trial in Carbohydrate Counting (DIET-CARB Study in Type 1 Diabetes
Condition: Type1diabetes; Type1 Diabetes Mellitus; Glucose Metabolism Disorders
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1; Metabolic Diseases; Glucose Metabolism Disorders
Study type: Interventional

Summary: 
      The study is designed to evaluate two different dietitian-led self-management approaches in
      carbohydrate counting compared to routine dietary care (control) on glycaemic control in
      adult patients with type 1 diabetes:

        1. The basic carbohydrate counting concept aims at improving carbohydrate counting accuracy
           and day-to-day consistency of carbohydrate intake (the BCC intervention)

        2. The advanced carbohydrate counting concept aims at improving prandial insulin dose
           accuracy using an automated bolus calculator (the ABC-ACC intervention)

      The main hypothesis is that structured training and education in either the BCC concept or
      the ABC-ACC concept will reduce HbA1c or the average glucose variability more than routine
      dietary education.
    

Detailed description: 
      The current study is a randomized controlled trial with a parallel-group design. A total of
      231 patients will be enrolled in the trial. Participants will be randomized to one of three
      arms: 1) Basic carbohydrate counting (BCC), 2) Advanced carbohydrate counting with an
      automated bolus calculator (ABC-ACC), or 3) Standard dietary care.

      The primary objective is to evaluate the six months effects of education in the BCC concept
      and the ABC-ACC concept compared to standard dietary care on glycaemic control as assessed by
      HbA1c or MAGE (mean amplitude of glycaemic excursions).
    

Intervention name(s): BCC intervention; ABC-ACC intervention; Standard dietary education
Intervention type(s): Behavioral; Behavioral; Behavioral
Intervention description(s): Structured training and education i basic carbohydrate counting principles; Structured training and education i advanced carbohydrate counting principles including the use of a automated bolus calculator carbohydrate; Personalized individual dietary counselling based on overall meal planning, dietary guidelines and the patient's need and preferences
Other intervention name(s): Basic carbohydrate counting; Advanced carbohydrate counting with a bolus calculator; Routine dietary care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Carbohydrate counting; Basic carbohydrate counting; Advanced carbohydrate counting; Carbohydrates; Diet
The Effect of Zinc, β-carotene, and Vitamin D3 in Preterm Delivery Through Placental MyD88, TRIF, NFkB, and IL-1β
Condition: PreTerm Birth
MeSH terms: Premature Birth
Study type: Interventional
Phase: Phase 4

Summary: 
      This study is a controlled trial which compares the effect of zinc, beta-carotene, and
      Vitamin D3 supplementation in pregnant women which has preterm birth. The measured outcome is
      zinc, vitamin A, and 25(OH)D level in serum and placenta, MyD88, TRIF, NFκB, and IL-1β levels
      in placenta.
    

Detailed description: 
      The research will be held in Cipto Mangunkusumo General and Budi Kemuliaan Hospital.

      Each participant of each group will be given the medication of preterm birth hospital
      protocol, which includes nifedipine 4x10 mg as tocolytic agent, dexamethasone 2x6 mg
      intravenous for 2 days which aims to support lung maturation, and antibiotic. Then, the blood
      sample is obtained for zinc, vitamin A and 25(OH)D levels examination. Subjects will be
      divided into 2 groups which are group whose given the oral zinc 50 mg/day, oral beta-carotene
      25,000 IU and oral vitamin D3 50,000 IU/week supplementation, and group who is not given the
      intervention. Each participant will be observed until delivery. After delivery, level of
      zinc, vitamin A, and 25(OH)D in serum and placenta will be measured, as well as level of
      MyD88, TRIF, NFκB, and IL-1β in placenta.
    

Intervention name(s): Zinc; Nifedipine; Beta Carotene; Vitamin D3; Dexamethasone
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): included in intervention arm; included in intervention and control arm; included in intervention arm; included in intervention arm; included in intervention and control arm
Other intervention name(s): Zinc Picolinate 50 mg; Nifedipine 10 mg; Beta carotene 25,000 IU; Cholecalciferol 50,000 IU; Dexamethasone 6 mg
Intervention MeSH terms: Vitamin D; Cholecalciferol; Beta Carotene; Zinc; Dexamethasone; Dexamethasone acetate; Nifedipine; BB 1101; Carotenoids; Picolinic acid
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Community Interventional Trial (CITFOMIST)
Condition: Vitamin D Deficiency
MeSH terms: Vitamin D Deficiency
Study type: Interventional

Summary: 
      The cluster randomized trial (CITFOMIST) was conducted on 15-19-year old guidance and high
      school students of both genders from different districts of Tehran, the Iranian capital, in
      winter 2011. The 36 schools enrolled in this study were randomly assigned to receive one of
      the three groups of milk -- whole milk, milk that contained 600 IU Vit D/1000cc, milk that
      contained 1000 IU Vit D /1000cc -- for a 30-day period. In order to study the effect of
      vitamin D-fortified milk on the circulating concentrations of 25(OH)D, a serum vitamin D
      levels were checked in a subgroup before and after the intervention.
    

Detailed description: 
      The cluster randomized trial (CITFOMIST) was conducted on 15-19-year old guidance and high
      school students of both genders from different districts of Tehran, the Iranian capital, in
      winter 2011.

      The 36 schools enrolled in this study were randomly assigned to receive one of the three
      groups of milk -- whole milk, milk that contained 600 international unit (IU) Vit D/1000cc
      (120IU), milk that contained 1000 IU Vit D /1000cc (200IU)-- for a 30-day period. In order to
      study the effect of vitamin D-fortified milk on the circulating concentrations of 25(OH)D, a
      serum vitamin D levels were checked in a subgroup before and after the intervention.
    

Intervention name(s): 120 IU milk; 200 IU Milk; Non-Fortified Milk
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): Daily consumption of milk fortified with 120 IU vitamin D; Daily Consumption of milk fortified with 200 IU vitamin D; Daily consumption of non-fortified milk
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Diagnostic
Keywords: Vitamin D Deficiency; Compliance; Milk
HSV1716 in Patients With Non-Central Nervous System (Non-CNS) Solid Tumors
Condition: Rhabdomyosarcoma; Osteosarcoma; Ewing Sarcoma; Soft Tissue Sarcoma; Neuroblastoma; Wilms Tumor; Malignant Peripheral Nerve Sheath Tumor; Clival Chordoma; Non-CNS Solid Tumors
MeSH terms: Neoplasms; Sarcoma; Neuroblastoma; Osteosarcoma; Rhabdomyosarcoma; Sarcoma, Ewing; Wilms Tumor; Chordoma; Nerve Sheath Neoplasms; Neurofibrosarcoma
Study type: Interventional
Phase: Phase 1

Summary: 
      Patients with relapsed solid tumors such as sarcomas and neuroblastoma have a poor survival,
      generally < 20%. There is an urgent need for new treatments that are safe and effective.

      HSV1716, an oncolytic virus, is a mutant herpes simplex virus (HSV) type I, deleted in the
      RL1 gene which encodes the protein ICP34.5, a specific determinant of virulence. Mutants
      lacking the RL1 gene are capable of replication in actively dividing cells but not in
      terminally differentiated cells - a phenotype exploited to selectively kill tumor cells. In
      previous clinical studies, HSV1716 has been shown to be safe when injected at doses up to
      10^5 plaque forming units (pfu) directly into human high-grade glioma and into normal brain
      adjacent to tumour, following excision of high-grade glioma. In an extension study, HSV1716
      has been shown to be safe when injected at a dose of up to 10^6 pfu directly into brain
      tumours. Replication of HSV1716 in human glioblastoma in situ has been demonstrated.
      Following a single administration of HSV1716 by direct injection into active recurrent tumor
      or brain adjacent to tumor, some patients have lived longer than might have been expected.
      This study seeks to evaluate the safety of a single injection of HSV1716 in the treatment of
      extracranial solid tumors in adolescents and young adults.

      HSV1716 has also proved safe when given by direct intra-tumoural injection in patients with
      squamous carcinoma of the head and neck, and in patients with malignant melanoma.

      Replication of HSV mutants in human sarcomas and neuroblastoma in cultured cells and human
      xenograft models has been demonstrated.

      This study is designed in two parts. PART 1 of the study specifies a single dose of virus.
      Participants who experience at least stable disease or relapse following a determination of
      stable disease, may qualify for subsequent doses in PART 2. PART 2 requires signing of a
      separate consent.

      Funding Source - FDA OOPD
    


Intervention name(s): HSV1716
Intervention type(s): Biological
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Evaluating the Efficacy and Safety of Zonisamide in the Treatment of Partial Seizures
Condition: Partial Seizures
MeSH terms: Seizures
Study type: Interventional
Phase: Phase 3

Summary: 
      The objectives of this trial are to evaluate the safety and efficacy of Zonisamide as
      adjunctive therapy in medically refractory patients receiving other antiepileptic drugs
      (AEDs).
    


Intervention name(s): Zonisamide; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Patients entered a 4-week titration period, during which zonisamide dosing began at 100 mg/day for the first 2 weeks, increased to 200 mg/day for the 3rd week, and to 300 mg/day for the 4th week, reaching 300 mg/d at the end of the titration period. 300 mg/d was the target dose in the titration period and must be reached. Dose increment was continued to 400 mg/d if this was tolerated by the patient.; Patients in placebo group were titrated with placebo in the same way as in zonisamide group.
Other intervention name(s): Zonegran
Intervention MeSH terms: Zonisamide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Epilepsy; Partial seizures
Safety and Tolerability of Pharmaton Capsules in Healthy Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this trial was to evaluate the safety and tolerability of a galenic
      formulation of Pharmaton® capsules containing 2-Dimethylaminoethanol (DMAE) in healthy
      volunteers.
    


Intervention name(s): Pharmaton® with DMAE; Pharmaton® without DMAE; Placebo
Intervention type(s): Drug; Drug; Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
SAD and MAD Study With IV and SC Doses of ARGX-117
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a phase 1, first-in-human, double-blinded, randomized, placebo-controlled, escalating
      single and multiple dose levels trial to evaluate the safety, pharmacokinetics,
      pharmacodynamics, and immunogenicity of ARGX-117 administered IV and/or SC. Up to 112
      healthy, adult male and female subjects of non-childbearing potential will be enrolled in
      this trial.
    


Intervention name(s): ARGX-117; Placebo; ARGX-117 + rHuPH20; placebo + rHuPH20; ARGX-117 PH20 SC; Placebo PH20 SC
Intervention type(s): Biological; Other; Biological; Other; Biological; Other
Intervention description(s): Subjects treated with ARGX-117; Subjects treated with placebo; Subjects treated with ARGX-117 + rHuPH20; Subjects treated with placebo + rHuPH20; Subjects treated with ARGX-117 PH20 SC; Subjects treated with placebo PH20 SC
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Other
PeerScope B System™ Clinical Protocol
Condition: Colon Cancer; Colon Diseases; Colon Polyps; Colon Adenomas
MeSH terms: Adenoma; Colonic Diseases
Study type: Interventional

Summary: 
      The PeerScope B System™ by PeerMedical Ltd. is intended to provide visualization (via a video
      monitor) and therapeutic access to the lower intestinal tract. The lower intestinal tract
      includes, but is not restricted to the organs, tissues and subsystems: large bowel and cecum.
      The device is introduced rectally, as with any standard colonoscope when indications
      consistent with the need for the procedure are observed in the adult patient population.

      The purpose of this prospective clinical study is to establish the usability of the PeerScope
      B System™ when used during standard colonoscopy procedure.

      The study population is comprised of patients indicated for colonoscopy.

      The primary endpoint is reaching the cecum of the colon with PeerScope B System™.Secondary
      endpoints:

        1. The first secondary endpoint is the incidence of complications using the PeerMedical
           colonoscope.

        2. The second secondary endpoint is successful therapeutic interventions as biopsies,
           polypectomies, APC etc.

        3. The third secondary endpoint is the procedure time.

        4. The fourth secondary endpoint is the subjective evaluation of the additional view angle
           by the physician.

        5. The fifth secondary endpoint is patient satisfactory.
    

Detailed description: 
      Founded in 2009, PeerMedical develops colonoscopes capable of wide view angle at the press of
      the button. The PeerScope B System™ is an endoscopic platform that enables the physician to
      get a wide angle view while maintaining all of the features commonly used during
      Gastrointestinal (GI) procedures with very limited learning curve and in service process. The
      current standard devices have viewing limitations. By adding this viewing functionality,
      PeerMedical will potentially empower physicians to improve polyps detection and cancers
      within the colon.
    

Intervention name(s): colonoscopy system (PeerScope B System™)
Intervention type(s): Device
Intervention description(s): Cancer of the colon and rectum is second only to lung cancer as the leading cause of cancer-related deaths in the United States.Each year, about 1.23 million new cases of bowel cancer are diagnosed worldwide, 333,000 in Europe alone. Colorectal cancer almost always starts in a benign growth called a polyp. Polyps originate in the inner lining of the colon, where they may be visible in a screening test known as colonoscopy. Recent research has shown that appropriate screening and treatment can alleviate much of the suffering associated with colorectal cancer and reduce the number of deaths caused by this malignancy
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Screening
Keywords: wide angle view colonoscopy; PeerScope B System™
Phase1a, Dose-escalation Study of NNI-362 in Healthy Aged Volunteers
Condition: Alzheimer Disease
MeSH terms: Alzheimer Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to examine the safety, tolerability and pharmacokinetics of
      single and multiple doses of NNI-362 in healthy aged population.
    

Detailed description: 
      The early clinical development strategy consists of the initial evaluation of safety and
      tolerability of NNI-362. This FIH Phase I includes single and multiple ascending dose studies
      in healthy aged volunteers. Assessment of suicidal ideation/behavior will be performed at
      baseline and at all study visits and on days of inpatient confinement in conformance with FDA
      recommendations.
    

Intervention name(s): NNI-362; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): NNI-362 small molecule in liquid suspension.; Placebo liquid suspension
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Placebo versus NNI-362 at 10 mg, 20 mg, 60 and 120 mg liquid suspension
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Effects of rhBNP in Pediatrics After Corrective Repair of Tetralogy Of Fallot
Condition: Congenital Heart Defects; Tetralogy Of Fallot
MeSH terms: Heart Defects, Congenital; Tetralogy of Fallot
Study type: Interventional

Summary: 
      The purpose of this study is to determine the effects of rhRNP on urine output and
      hemodynamics following corrective repair of Tetralogy Of Fallot.
    

Detailed description: 
      CVP(central venous pressure) and cardiac output are serious index in children with Tetralogy
      Of Fallot after the corrective repair.The purpose of this study is to investigate if the
      therapy of rhRNP can improve the survival and life quality after the corrective repair of
      Tetralogy Of Fallot.
    

Intervention name(s): recombinant human brain natriuretic peptide (rhBNP); Placebo (0.9% sodium chloride)
Intervention type(s): Drug; Drug
Intervention description(s): Patients are first given a loading dose of recombinant human brain natriuretic peptide (rhBNP) 1.5 mcg/kg, followed by continuous infusion recombinant human brain natriuretic peptide 0.01-0.01mcg/kg/min for 72 hours.; Patients after corrective repair of Tetralogy Of Fallot will be treat with routinely therapy, including inotropics and diuretics, combined a placebo infusion 24 hours after operation.
Intervention MeSH terms: Natriuretic Peptide, Brain
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Heart defects, Congenital; rhBNP; heart failure
An Investigation of Chemotherapy Induced Cognitive Impairments in Breast Cancer Survivors
Condition: Breast Cancer
MeSH terms: Breast Neoplasms; Chemotherapy-Related Cognitive Impairment; Cognitive Dysfunction
Study type: Interventional

Summary: 
      The main goal of this project is to identify and remediate the cognitive difficulties,
      including processing speed and attention deficits in individuals who have undergone
      chemotherapy treatment. Recent research has demonstrated objective cognitive deficits
      following chemotherapy and that it is not an emotional reaction to the cancer diagnosis as it
      was once considered. There are a large number of woman diagnosed and treated for breast
      cancer that experience chemotherapy induced cognitive deficits.

      Subjects who participate in the study will be evaluated for cognitive abilities prior to
      chemotherapy treatment and after completion of chemotherapy. Participants will then have the
      option to participate in the second phase of the study, which involves the use of a
      computer-based Brain Fitness Program for 12 weeks. This is followed by another cognitive
      evaluation.
    


Intervention name(s): Brain Fitness Program (BFP)
Intervention type(s): Other
Intervention description(s): The program is designed to improve processing speed of auditory information and attention. The BFP is comprised of six computerized subtests that continuously adjust in the level of difficulty to maintain an 85% correct response rate. The subtest exercises include discrimination of confusable syllables, recognition of sequences of syllables, matching pairs of confusable syllables, reconstruction of sequences of verbal instructions and identification of details in a verbally presented story. Participants will participate in 40 one-hour training sessions over a 12 week period to complete all cognitive remediation training sessions. Since this intervention is presented both visually and verbally, noise cancelling headphones will be provided to the participants.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Post-chemotherapy; cognitive impairment
A Study of Subcutaneously-administered Guselkumab Delivered by 3 Different Devices in Healthy Participants
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the serum concentration of guselkumab after
      administration using three different devices in healthy participants.
    


Intervention name(s): Guselkumab
Intervention type(s): Drug
Intervention description(s): Guselkumab will be administered subcutaneously.
Other intervention name(s): CNTO 1959
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
A Study to Assess the Safety and Immunogenicity of PXVX0317 Chikungunya Virus Virus-Like Particle Vaccine
Condition: Chikungunya Virus
MeSH terms: Chikungunya Fever
Study type: Interventional
Phase: Phase 2

Summary: 
      The objective of this study is to assess the safety and immunogenicity of PXVX0317
      (Chikungunya Virus Virus-Like Particle Vaccine [CHIKV VLP], aluminum hydroxide adjuvanted).
    

Detailed description: 
      Primary Objectives:

        1. To assess the induction of anti-CHIKV neutralizing antibody responses following a single
           adjuvanted dose of PXVX0317 (40 µg CHIKV VLP, alum-adjuvanted) as measured 21 days (Day
           22) after vaccination.

        2. To assess the induction of anti-CHIKV neutralizing antibody responses following a single
           adjuvanted dose of PXVX0317 as measured 7 days (Day 8), 14 days (Day 15), and 56 days
           (Day 57) after vaccination.

      Secondary Objectives:

      1. To assess safety of a single adjuvanted dose of PXVX0317 in healthy adults.
    

Intervention name(s): CHIKV VLP, adjuvanted
Intervention type(s): Biological
Intervention description(s): Adjuvanted formulation includes aluminum hydroxide
Intervention model: Single Group Assignment
Intervention model description: Open Label Safety and Immunogenicity
Masking: None (Open Label)
Primary purpose: Prevention