bioihbjkbjnl/mcl2 huggingface dataset:
Molecular Imaging of HER2 Expression in Breast Cancer Using 99mTc-HE3-G3
Condition: Primary Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      The study should evaluate distribution of 99mTc-HE3-G3 in patients with primary HER2-positive
      and HER2-negative breast cancer.

      The primary objective are:

        1. To assess distribution of 99mTc-HE3-G3 in normal tissues and in tumours over time;

        2. To evaluate dosimetry of 99mTc-HE3-G3;

        3. To obtain initial information concerning safety and tolerability of 99mTc-HE3-G3 after
           single intravenous injection:

      The secondary objective are:

      1.To compare the tumour imaging data with the concerning HER2 expression obtained by
      immunohistochemistry (IHC) or fluorescent in situ hybridisation (FISH) analysis of biopsy
      samples.
    

Detailed description: 
      Overall goal of the project: To determine HER2 expression level in primary breast cancer and
      possibly in axillary lymph node metastases before neoadjuvant trastuzumab therapy.

      Phase I. Distribution of 99mTc-HE3-G3 in patients with primary breast cancer. The study
      should evaluate distribution of 99mTc-HE3-G3 in patients with primary HER2-positive and
      HER2-negative breast cancer.

      The primary objective are:

        1. To assess distribution of 99mTc-HE3-G3 in normal tissues and in tumours over time;

        2. To evaluate dosimetry of 99mTc-HE3-G3;

        3. To obtain initial information concerning safety and tolerability of 99mTc-HE3-G3 after
           single intravenous injection:

      The secondary objective are:

      1. To compare the tumour imaging data with the concerning HER2 expression obtained by
      immunohistochemistry (IHC) or fluorescent in situ hybridisation (FISH) analysis of biopsy
      samples:

      Methodology:

      Open-label, exploratory, single centre study. The subjects will receive a single injection of
      the labelled tracer.
    

Intervention name(s): SPECT
Intervention type(s): Drug
Intervention description(s): One single injection of 99mTc-HE3-G3, followed by gamma camera imaging directly postinjection and after 2, 4, 6 and 24 hours.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Diagnostic
Keywords: 99mTc-HE3-G3; Breast Cancer; HER2 expression
Glycaemic Index (GI) Evaluation of Carbohydrate-based Food With Functional Ingredients Derived From Food Sources
Condition: Postprandial Hyperglycemia
MeSH terms: Hyperglycemia
Study type: Interventional

Summary: 
      In Singapore, the Ministry of Health has declared a "War on Diabetes" and major efforts will
      be made to develop and deploy programs to prevent diabetes. One of the cornerstones of
      diabetes management involves dietary modifications to reduce postprandial hyperglycaemia.
      However, implementation of a low GI diet is highly complex requiring the individual to choose
      foods from a long list which are primarily based on western consumption patterns. Many foods
      in the Asian diet, which largely consist of carbohydrates such as white rice, noodles and
      other flour based products, are not represented. An alternative solution will require
      innovative ways to alter commonly available food products that will not only help reduce
      postprandial glycaemia but also preserve the sensory characteristics of the foods to create a
      new generation of food products both functional and palatable. One such approach is the
      incorporation of plant compounds that lower the glucose absorption from foods. The aim of the
      project is to measure the GI of carbohydrate-based food with edible plant derived molecules.
      Natural, plant-derived anthocyanin will be incorporated into bread to produce low GI bread.
      Anthocyanins are well known for its anti-oxidant activity and recent studies reported that
      anthocyanins also had an inhibitory activity against digestive enzymes that break down
      carbohydrates. It can potentially inhibit amylase, and suppress the increase in postprandial
      glucose level from starch. Bread is a carbohydrate-rich product, which contains a high amount
      of rapidly digestible starch, and therefore many of them have a high GI. This study aims to
      determine the glycaemic effects of anthocyanin fortified bread. The effort is designed to
      enable and inform population interventions that will have an impact on the health of the
      population in a sustainable manner by introducing innovative foods into the food supply that
      are 'health promoting' based on rigorous human experiments and are acceptable to the public
      and other major stakeholders.
    


Intervention name(s): Anthocyanin
Intervention type(s): Dietary Supplement
Intervention description(s): 25% w/w anthocyanin extract obtained from black rice
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Glycemic index; Postprandial hyperglycemia; Anthocyanin; Black rice
Prediction of Migraine Prevention Efficacy Based on Individual's Pain Modulation
Condition: Migraine; Preventive Treatment
MeSH terms: Migraine Disorders
Study type: Interventional

Summary: 
      A major reason for the substantial underuse of pharmacological prevention of migraine is its
      inadequate efficacy, since only ~50% of patients respond to a specific agent. There is
      currently no evidence-based way to identify the patients that will respond to a specific
      preventive treatment. Amitriptyline is one of the commonest agents used for migraine
      prevention, strengthening patient's pain inhibitory capacity. Individual tailoring of
      analgesics according to pain inhibitory capacity has been shown effective by our group for
      painful diabetic neuropathy patients. Specifically, patients with reduced pain inhibition
      capacity gained more from a drug that augment pain inhibition as compared to those with
      efficient inhibitory capacity. The investigators now propose to assess migraineurs for their
      pain inhibition capacity, and examine whether, along similar reasoning, those with reduced
      inhibitory capacity are the ones more likely to respond to amitriptyline. Psychophysical and
      neurophysiological dimensions of pain inhibitory modulation will be assessed in migraineurs,
      who will, subsequently, receive either amitriptyline or placebo for 8 weeks, in a randomized
      two arms parallel double blind design, and followed up for attacks reduction. The
      investigators expect to identify the best predictors for efficacy of migraine prevention by
      the study drug. This approach will promote individualization of migraine therapy.
    


Intervention name(s): Amitriptyline; placebo
Intervention type(s): Drug; Drug
Intervention description(s): per os, daily, evening; per os, daily, evening
Other intervention name(s): Elatrol; sugar pills
Intervention MeSH terms: Amitriptyline
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Other
Keywords: migraine; Amitriptyline; pain modulation; pain psychophysics; pain neurophysiology; preventive treatment
A Study to Evaluate the Safety and Tolerability of ONL1204 in Patients With Macula-off, Rhegmatogenous Retinal Detachment
Condition: Rhegmatogenous Retinal Detachment - Macula Off
MeSH terms: Retinal Detachment; Dissociative Disorders
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the safety and tolerability of ONL1204 in
      participants with Macula-off, Rhegmatogenous Retinal Detachment (RRD). RRD is an acute and
      serious vision threatening condition in which a tear in the retina, typically resulting from
      a vitreous detachment, allows liquid to accumulate under the retina, detaching the
      photoreceptor (PR) layer of the retina from the retinal pigment epithelium (RPE). As the RPE
      is the principal source of nutritional support for the PR layer, the photoreceptors begin a
      cascade of inflammation and cell death. Photoreceptor cell death is the primary mechanism of
      vision loss after retinal detachment.

      ONL1204 is a first-in-class inhibitor of Fragment Apoptosis Stimulator receptor
      (Fas)-mediated cell death. ONL1204 has demonstrated protection of multiple retinal cell types
      in numerous preclinical models of acute ocular injury. This will be a first-in-human (FIH)
      study to evaluate safety and tolerability of a single-dose of ONL1204 in participants with
      macula-off RRD. The standard of care for surgical repair of macula-off RRD is reattachment
      surgery within 7 days of the macula detaching. Participants in this study will receive a
      single intravitreal injection upon diagnosis and enrollment in the study, followed by
      standard of care surgery. The surgery includes vitrectomy, a procedure that removes the bulk
      of drug remaining in the vitreous.
    


Intervention name(s): ONL1204; Intravitreal Injection; Collection of ocular fluids
Intervention type(s): Drug; Procedure; Procedure
Intervention description(s): Administration of ONL1204 - inhibitor of Fas(CD95) signaling by intravitreal injection; Injection of study drug into the eye; vitreous and aqueous fluid collection by a tap and during vitrectomy
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Outcomes Study of Hyperinsulinemic Glucose Control in Cardiac Surgery
Condition: Cardiac Surgery
Study type: Interventional

Summary: 
      Patients undergoing cardiac surgery will be randomized into one of two groups. Group A will
      be administered insulin using the hyperinsulinemic-normoglycemic clamp to normalize blood
      glucose levels intra-operatively. Group B will be administered insulin at the standard of
      care levels established by the participating institution. Patients will be followed at 10
      days, 15 days and one year post-operatively.
    

Detailed description: 
      Using a randomized, controlled design, we propose to test the primary hypothesis that
      normalization of blood glucose using a hyperinsulinemic-normoglycemic clamp technique reduces
      the risk of a composite outcome (one or more) of 30-day postoperative mortality and serious
      postoperative cardiac, renal, neurologic, and infectious postoperative complications in
      patients undergoing cardiac surgery.

      Our secondary hypothesis is that hyperinsulinemic normoglycemic therapy will reduce length of
      stay in intensive care unit, atrial dysrhythmias, creatinine elevation, hospital readmission,
      all-cause and cardiac one-year mortality.
    

Intervention name(s): Hyperinsulinemic-normoglycemic clamp; insulin at the standard of care levels
Intervention type(s): Other; Other
Intervention description(s): Patients will be randomized to receive the hyperinsulinemic-normoglycemic clamp titrating the blood glucose to 80-110 mg/dL.; Subjects will be administered insulin at the standard of care levels established by the participating institution.
Other intervention name(s): clamp; Hyperinsulinemic; insulin
Intervention MeSH terms: Insulin; Insulin, Globin Zinc
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: Hyperinsulinemic glucose control; cardiac surgery; Outcome
To Evaluate the Effectiveness of an Injury Prevention Program in Athletics
Condition: Athletics; Wounds and Injuries; Prevention Program
MeSH terms: Wounds and Injuries
Study type: Interventional

Summary: 
      The practice of Athletics leads to risk of injuries: about 61 to 76% athletes will occurred
      at least one injury during a season. The prevention of Athletics injuries thus represents a
      major challenge for all stakeholders around athletes. In team sports, injury prevention
      programs have been implemented and scientifically validated. However, no injury prevention
      programs have been implemented and scientifically validated for Athletics. In this context, a
      primary objective will be to analyze the effectiveness of an Athletics Injury Prevention
      Program (AIPP) to reduce the frequency (percentage) of athletes presenting at least one
      injury complaint related to athletic practice at long term (40 weeks). A statistician will
      carry out a randomized control trial in cluster (clubs with AIPP and clubs without AIPP),
      multicenter, including athletes between 15 and 40 years old and licensed in athletic clubs
      and followed during an athletic season.
    

Detailed description: 
      The person in charge of the platform will collect on a weekly basis via a IT-questionnaire
      sent out automatically every Monday the following parameters: injury complaints (presence or
      absence, and characteristics if presence) and exposure (number of hours of athletic practice
      (training and competition) and intensity), and the number of AIPP realization per week. The
      main criterion will be the frequency (percentage) of athletes presenting at least one injury
      complaint that have a consequence on the practice (reduction or cessation of practice).
    

Intervention name(s): Athletics Injury Prevention Program; regular training
Intervention type(s): Other; Other
Intervention description(s): The Athletics Injury Prevention Program (AIPP) will be performed by experimental group twice a week. The AIPP is composed of 8 exercises including core stability, balance, pelvic stabilization, stretching and strengthening of the Achilles tendon and hamstrings.; The regular training will be performed by control group according to the standard practice.
Other intervention name(s): AIPP; standard practice
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Program; Prevention; Injury; Athletics
A Open-Label Study Of CP-690,550 As Long-Term Therapy (48 Weeks) In Subjects With Crohn's Disease
Condition: Crohn's Disease
MeSH terms: Crohn Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      The study hypothesis is to establish the safety and tolerability of long-term open-label (OL)
      CP-690,550 therapy in subjects with Crohn's disease.
    


Intervention name(s): CP-690,550; CP-690,550
Intervention type(s): Drug; Drug
Intervention description(s): ORAL TABLET, TWICE DAILY; ORAL TABLETS, TWICE DAILY
Intervention MeSH terms: Tofacitinib
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Masitinib in Treatment of Patients With Severe Persistent Asthma Treated With Oral Corticosteroids
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 3

Summary: 
      The study objective is to compare the efficacy and the safety of masitinib at 6 mg/kg/day
      versus placebo in the treatment of patients with Severe Persistent Asthma treated with oral
      corticosteroids.
    

Detailed description: 
      Masitinib is a selective tyrosine kinase inhibitor. It is known that activation of
      inflammatory cells, such as mast cells, and fibrous tissue remodeling are associated with
      c-Kit, Lyn and PDGFR kinase signaling pathways; all key targets of masitinib. The objective
      of this study is to compare the efficacy and safety of masitinib at 6 mg/kg/day versus
      matched placebo in severe persistent asthma patients that is uncontrolled with oral
      corticosteroids. The primary outcome measure will be severe asthma exacerbation rate over
      duration of the treatment.
    

Intervention name(s): Masitinib; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 6 mg/kg/day
Other intervention name(s): AB1010; Placebo Oral Tablet
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: severe persistent asthma; tyrosine kinase inhibitor
Inhaled Sevofluran vs Endovenous Propofol for Colonoscopy
Condition: Anesthesia
Study type: Interventional

Summary: 
      To compare the anesthetic efficacy of the inhalation versus intravenous technique for
      maintenance of sedation in patients undergoing endoscopy.

      A longitudinal, randomized clinical study of 32 patients of both sexes ASA I-III, aged 18-80
      years undergoing diagnostic colonoscopy, which was randomly divided into 2 groups. In both,
      intravenous induction with propofol (2-2.5 mg / kg) was performed, Group A remained sedated
      with propofol infusion (1-2 mg / kg / min); Group B by inhalation with sevoflurane at a
      concentration of 2 vol% through a nasal cannula with an oxygen flow.
    


Intervention name(s): Propofol; Sevoflurane
Intervention type(s): Drug; Drug
Intervention description(s): after inicial bolus of propofol, remained sedated with propofol infusion (1-2 mg/kg/min); after inicial bolus of propofol, remained sedated by inhalation with sevoflurane at a concentration of 2 vol% through a nasal cannula with an oxygen flow.
Intervention MeSH terms: Propofol; Sevoflurane
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: sedation; colonoscopy
Electronic Pre-exposure Prophylaxis (PrEP) Initiation and Maintenance Home Care System
Condition: Pre-exposure Prophylaxis
Study type: Interventional

Summary: 
      The premise for the study is that a tailored approach for rural young men who have sex with
      men (YMSM), addressing known barriers of transportation, access to providers, and privacy, is
      most likely to yield high levels of Pre-exposure Prophylaxis (PrEP) initiation and
      persistence in care.
    

Detailed description: 
      The premise for the study is that a tailored approach for YMSM from rural and small town
      areas, addressing known barriers of transportation, access to providers, and privacy, is most
      likely to yield high levels of PrEP initiation and persistence in care. The study sites are
      Alabama, Georgia, North Carolina, and Mississippi.

      Using a smartphone application (app), participants assigned to the intervention will receive
      and maintain a PrEP prescription without needing to leave their home (excepting pharmacy
      pick-up in some cases) - achieved through app-based surveys/screenings, telemedicine
      consultations, and home specimen self-collection.
    

Intervention name(s): ePrEP
Intervention type(s): Other
Intervention description(s): Participants will have a baseline teleconsultation with a site study clinician who will be responsible for prescribing PrEP as indicated. They will be offered a 1-month check-in and telemedicine consultations at 3, 6, 9 and 12 months. Participants will complete home specimen collection for laboratory tests for each consultation. The virtual study visit consists of surveys, specimen collection, and a telemedicine consultation.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: PrEP; MSM; HIV; telemedicine; randomized controlled trial
Primary Prevention Program
Condition: Primary Prevention of Cardiovascular Disease
MeSH terms: Cardiovascular Diseases
Study type: Interventional

Summary: 
      A systematic collection of retrospective and prospective data based on non-intervention
      patient observation, aimed to assess the risks, course and outcomes of a disease or a group
      of diseases:

        -  the retrospective part: database of patients with cardiovascular risks;

        -  the prospective part: observation of patients in the real medical practice
    

Detailed description: 
      The research program will have two parts:

      Stage1: identification of patients with moderate, high and very high cardiovascular risks,
      not having diseases of atherosclerotic genesis and requiring lipid-lowering drugs.

      Stage 2: a prospective observation of patients receiving primary medical prophylaxis of CVD
      with atorvastatin
    

Intervention name(s): extended counseling
Intervention type(s): Behavioral
Intervention description(s): Patients are handed out information leaflets on the correction of risk factors, SMS reminders, extended statins counseling.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: primary prevention; cardiovascular risk; hyperlipidaemia; adherence
Repetitive Transcranial Magnetic Stimulation in Central Neuropathic Pain
Condition: Neuropathic Pain
MeSH terms: Neuralgia
Study type: Interventional

Summary: 
      The repetitive transcranial magnetic stimulation (rTMS) is used in pain treatment for several
      years. The aim of the study is to assess, in a rigorous scientific protocol, analgesic effect
      of the neuronavigated rTMS assisted by robotic arm on chronic neuropathic painful subjects.
      The crossover study is randomized, double blinded and controlled (sham rTMS) and it includes
      a large homogeneous population suffering of central neuropathic pain.
    

Detailed description: 
      The repetitive transcranial magnetic stimulation (rTMS) is used in pain treatment for several
      years. The latest meta-analysis showed that rTMS has not prove its scientific efficacy. It
      could be explained by several reasons: poor methodologic quality, stimulations parameters,
      technologic hardware, ... The aim of the study is to assess, in a rigorous scientific
      protocol, analgesic effect of the neuronavigated rTMS assisted by robotic arm on chronic
      neuropathic painful subjects. The crossover study is randomized, double blinded and
      controlled (sham rTMS) and it includes a large homogeneous population suffering of central
      neuropathic pain. The stimulated region is the primary motor cortex with high frequency
      (20Hz). This study has two periods (real and sham) of 12 weeks with four sessions of
      stimulation per period and 8 weeks of washout between the two.
    

Intervention name(s): active rTMS then sham rTMS; sham rTMS then active rTMS
Intervention type(s): Device; Device
Intervention description(s): A first period during which the patient will have 1 session of active rTMS every 3 weeks for 3 months A 2nd period during which the patient will have 1 session of sham rTMS every 3 weeks for 3 months; A first period during which the patient will have 1 session of sham rTMS every 3 weeks for 3 months A 2nd period during which the patient will have 1 session of active rTMS every 3 weeks for 3 months
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Neuropathic Pain; repetitive transcranial magnetic stimulation (rTMS)