bioihbjkbjnl/mcl2 huggingface dataset:
Effects and Mechanism of Prolonged Continuous Theta Burst Stimulation on Neuropathic Pain
Condition: Neuropathic Pain; Repetitive Transcranial Magnetic Stimulation
MeSH terms: Neuralgia
Study type: Interventional

Summary: 
      Neuropathic pain (NP) is one type of refractory chronic pain condition,medical treatments for
      NP is limited because of its poorly response. A noninvasive brain-stimulation method called
      transcranial magnetic stimulation (TMS) has garnered interest as an alternative treatment for
      intractable NP potentially through inducing therapeutic brain plasticity.Indeed,
      high-frequency (≥ 5 Hz) Repetitive TMS (rTMS) over the primary motor cortex (M1) is suggested
      to be able to reduce neuropathic pain in randomized controlled studies.Overall, the clinical
      application of rTMS in chronic pain is still limited by the response rate,the investigation
      of rTMS protocols is important for improving rTMS analgesia. Theta burst stimulation (TBS)
      mimics the bursts of neuronal firing which results in robust long-term potentiation.
      Continuous TBS (cTBS) is designed to decrease excitability, whereby prolonged cTBS (pcTBS,
      i.e. multiple cTBS being delivered continuously) has recently been demonstrated to increase
      excitability. More importantly, pcTBS was found to have comparable or even better analgesic
      effects than standard 10 Hz rTMS. These findings together call for more studies to validate
      the analgesic efficacy of pcTBS.

      In this study, the investigators aim to assess and compare the efficacy of prolonged
      continuous theta burst stimulation (pcTBS) with 10HZ rTMS in NP patients.
    

Detailed description: 
      The investigators designed a randomized, double-blind, sham-controlled study at 1 center.
      fifty NP patients were randomly assigned to 3 groups. A series of 5 daily pcTBS(1200
      pulses/session) or 10-Hz rTMS (1500 pulses/session) of primary motor cortex (M1) or sham
      stimulation was applied to each patients.
    

Intervention name(s): Repetitive transcranial magnetic stimulation; Repetitive transcranial magnetic stimulation; Sham stimulation
Intervention type(s): Device; Device; Device
Intervention description(s): Participants received 10HZ rTMS protocol consisted of 5 sessions over 5 consecutive workdays; Participants received pcTBS protocol consisted of 5 sessions over 5 consecutive workdays; Participants received Sham rTMS stimulations consisted of 5 sessions over 5 consecutive workdays
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: fifty NP patients were randomly assigned to 3 groups.
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Hypothalamic Function Before and After Bariatric Surgery
Condition: Obesity; Diabetes
MeSH terms: Diabetes Mellitus; Obesity
Study type: Observational

Summary: 
      The purpose of this study is to determine the effect of gastric banding or gastric bypass on
      hypothalamic morphology and function, gut hormones and systems biology in obese subjects with
      and without type 2 diabetes.
    


Intervention name(s): Roux en Y gastric bypass and lap. gastric banding; Prodimed dietary intervention
Intervention type(s): Procedure; Behavioral
Intervention description(s): Standard RYGB and LAGB procedures; 3 months of using the prodimed diet
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Obese (type 2 diabetic or not) population from primary care (dietary intervention) and
        hospital setting (bariatric surgery)
      
Biospecimen description: 
      Blood/Sera Adipose tissue biopsies
    
Keywords: Obesity; Diabetes; Bariatric surgery
Primary Intervention With Mucosal Insulin
Condition: Type 1 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      A dose with proven drug bioavailability to the immune system for use in a phase II/III
      primary T1DM (type 1 diabetes) vaccination trial (POINT study) in genetically at risk
      subjects.

      Study Design Randomized, placebo-controlled, double-blind/double-masked, multi-center, dose
      escalation primary intervention pilot study.

      Accrual Objective 25 (3:2 randomization to active and control arms)
    

Detailed description: 
      The objective of this study is to determine the feasibility, safety and bioavailability of
      oral insulin in children with high genetic risk for T1DM in a dose escalation primary
      intervention pilot study.
    

Intervention name(s): Human Insulin; Oral Placebo
Intervention type(s): Drug; Other
Intervention description(s): There is a study drug dose increase once during the study. The dose increase will occur 6 months after entering into the study. A total of 6 children will be included at each dose (3 children will not have received insulin prior to entering the study and 3 children will have received a lower dose of insulin for 6 months). Further dose increases or more frequent dose increases in individual children will not be performed during Pre-POINT. Escalation will occur in both treatment and placebo group so that participants and study investigators will remain blinded to treatment throughout the study. First dose (2.5 mg oral insulin/day) Second dose (7.5 mg oral insulin/day) Third dose (22.5 mg oral insulin/day) Fourth dose (67.5 mg oral insulin/day); Oral Placebo is given orally daily
Other intervention name(s): Oral Insulin
Intervention MeSH terms: Insulin; Insulin, Globin Zinc
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Prevention
Keywords: Type 1 Diabetes; Diabetes; Autoimmune Diabetes
CDIAG Regimen in the Treatment of Relapsed or Refractory Acute Myeloid Leukemia
Condition: Acute Myeloid Leukemia, Relapsed, Adult
MeSH terms: Leukemia; Leukemia, Myeloid; Leukemia, Myeloid, Acute
Study type: Interventional
Phase: Phase 2

Summary: 
      This study is to investigate the therapeutic efficacy and side effect of chidamide,
      decitabine combined with priming IAG regimen for relapsed or refractroy acute myeloid
      leukemia
    


Intervention name(s): CDIAG regimen
Intervention type(s): Drug
Intervention description(s): Chidamide 30mg orally twice every week for 2 weeks on days 1, 4, 8, 11, decitabine 20mg/m2 intravenously daily for 5 days (d1-d5) and IAG regimen (cytarabine, 10 mg/m2 subcutaneously every 12 h on days 4-17; idarubicin, 5mg intravenously every other day on days 4, 6, 8, 10, 12, 14; and concurrent granulocyte colony-stimulating factor, 200mg/m2/day subcutaneously daily on days 3-17.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: chidamide; decitabine; priming regimen
Study of Fluid Collection of the Chest in Children With Pneumonia
Condition: Community Acquired Bacterial Pneumonia; Paraneumonic Effusion
MeSH terms: Pneumonia; Pneumonia, Bacterial
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to determine the best treatment for children with a fluid
      collection in the chest associated with an underlying pneumonia. Researchers generally agree
      that a child with a large fluid collection in the chest need to have the fluid drained in
      addition to anitbiotics. There have been many treatments studied in children that have been
      shown to be effective and safe, but the treatments have never been compared to each other in
      a randomized controlled study.

      The optimal treatment of pediatric parapneumonic effusions remains controversial. The
      objective of this study is to compare the use of conventional management (antibiotics with
      thoracostomy tube placement) with primary thorascopic drainage (see protocol). Our hypothesis
      is that pediatric patients with parapneumonic effusion, regardless of pleural fluid
      composition and loculations, have decreased morbidity when treated with early thoroscopic
      adhesiolysis (VATS) compared with conservative treatment.
    

Detailed description: 
      The ultimate objective of this study is to rationalize treatment decisions. It is our hope
      that this pilot study will provide the basis for further randomized prospective studies. The
      expected benefit is that the current treatment and outcome of pediatric parapneumonic
      effusions will be determined. Insights into the therapy that results in the least morbidity,
      hospital days, (and therefore cost) will be elucidated. If our hypothesis is valid, then a
      more aggressive surgical approach to the treatment of a parapneumonic effusion may be
      warranted. If the hypothesis is not valid, then the appropriate treatment for a parapneumonic
      effusion, irrespective of institution and personal opinion, should become more apparent.
    

Intervention name(s): Video Assisted Thorascopic Surgery Thoracostomy Tube Placement & Drainage
Intervention type(s): Procedure
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Investigate Absorption, Metabolism and Excretion of [14C}-Proellex Following Single Oral Dose in Healthy Females
Condition: ABSORPTION; METABOLISM; EXCRETION
Study type: Interventional
Phase: Phase 1

Summary: 
      This study was to determine the ADME and metabolites of Proellex following a single oral dose
      of 25 mg.
    

Detailed description: 
      The purpose of this study is to determine the absorption, metabolism, and excretion kinetics
      of Proellex and to determine and characterize metabolites present in plasma and urine
      following a single oral dose of 25 mg. The 25 mg dose selected for this study has been
      included in all previous clinical trials. This dose was well tolerated and demonstrated
      efficacy against uterine fibroids and endometriosis.
    

Intervention name(s): Proellex
Intervention type(s): Drug
Intervention description(s): A single oral dose administered after at least a 10 hour fast
Other intervention name(s): Telapristone acetate
Intervention model: Single Group Assignment
Masking: None (Open Label)
Keywords: ABSORPTION; METABOLISM; EXCRETION
Neurocognitive and Neurobiological Improvement in ADHD Children With High Protein Diet
Condition: ADD; ADHD
MeSH terms: Attention Deficit Disorder with Hyperactivity
Study type: Interventional
Phase: Early Phase 1

Summary: 
      Multicenter, Prospective, randomized, comparative and controlled study about the beneficial
      effects in behavior and brain connectivity of different dietary patterns in 100 children with
      ADHD between 7 and 12 years, followed up for 3 months of nutritional therapy.
    

Detailed description: 
      We collect electroencephalogram (EEG), event related potentials (ERP) data, and behavior
      parameters in ADD/ADHD children that not take stimulants or other drugs during study. They
      would only follow some nutritional recommendations based on increasing the amount of dietary
      protein and fast carbohydrates decrease. The duration of the study will be 6 months, 3 months
      for recruitment and 3 months for dietary treatment.
    

Intervention name(s): BP22042013; Low carbohydrate diet
Intervention type(s): Drug; Dietary Supplement
Intervention description(s): This group of patients receive 2.000 kilo-calories diet (60 g. carbohydrates, 144 gr of fat and 107 gr of proteins), including 2 protein shakes.; the second group of patients receive diet of 2.000 Kilo-calories without rapidly absorbed carbohydrates and without proteins supplements
Other intervention name(s): Brain Proteins Supplements; 2000 Kilo-calories without Fast Absorbing Carbohydrate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Supportive Care
Keywords: ADD; ADHD; Proteins; Dietary; Nutrition; QEEG; ERP; ICA
Norwalk Feasibility Study
Condition: Behavior Problem; Development Delay; Emotional Disturbances; Family Conflict; Relation, Mother-Child
MeSH terms: Problem Behavior; Affective Symptoms
Study type: Interventional

Summary: 
      The purpose of this study is two-fold: 1) to examine the feasibility of the Drop-In model of
      Family Nurture Intervention (FNI); and 2) to collect pilot data concerning the mother's
      response to the Drop-In model of FNI and short term effects of participation. Feasibility of
      the Program will be measured through costs, staffing, space availability, and uptake.
      Participation in the Drop-In entails weekly visits for FNI. The investigators hypothesize
      that the Family Nurture Intervention will show feasibility through attendance and positive
      response to the Drop-In format. The investigators also expect the Family Nurture Intervention
      to improve mother's perceived well-being and mother-child emotional connection.
    

Detailed description: 
      Family Nurture Intervention (FNI) is a novel family-based program that facilitates
      mother-child emotional connection and co-regulation. Many current interventions aim at
      helping the child to self-regulate with or without the mother's help. However, the ability of
      the mother-child dyad to promote optimal development is dependent on their ability to
      co-regulate. The interactive co-regulation between the mother and the child shapes the
      behavior of both the mother and the child.

      This study aims to investigate the feasibility and short term effects of participation in the
      Family Nurture Intervention for preschool aged children with developmental and behavior
      problems. Mothers and children will be engaged by Nurture Specialists in comforting and
      calming interactions to co-regulate with each other during weekly group sessions with the
      support of study staff. Intervention sessions will occur over the course of eight weeks, and
      each mother will decide how many sessions to attend.
    

Intervention name(s): Family Nurture Intervention
Intervention type(s): Behavioral
Intervention description(s): The mother-child pair will be asked to talk and play with each other as the pair customarily does. If the child becomes restless and dysregulated, the mother will be coached by the Nurture Specialist to bring the child back into a calm state through sustained physical contact, comforting touch, soothing words and eye contact. Each dyad will be offered eight group FNI sessions.
Other intervention name(s): FNI
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Family Nurture Intervention; Martha G. Welch MD; Feasibility Study; Preschool intervention; Co-regulation; Emotional Connection; Multiple Family Group Intervention
A Single Dose PD & PK Study With Two Formulations of Abediterol in Patients With Asthma
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to investigate the pharmacodynamics of single doses of
      abediterol given by 2 different devices in participants with asthma. Abediterol (AZD0548) is
      a potential for once daily treatment of asthma and chronic obstructive pulmonary disease
      (COPD) in fixed dose combination (FDC) with an inhaled corticosteroid (ICS) or a novel
      anti-inflammatory agent. The aim of the clinical studies is to enable further investigations
      in participants with asthma and COPD to evaluate and develop abediterol as an effective long
      acting bronchodilator with an acceptable safety profile compared to other inhaled
      bronchodilators on the market, for the treatment of asthma and COPD.
    

Detailed description: 
      This is a randomised, double-blinded, double-dummy, placebo-controlled, multi-centre, six-way
      William's design, crossover study to assess the pharmacodynamics, pharmacokinetics, and
      safety of abediterol single dose, given by dry powder inhaler or pressurised metered-dose
      inhaler, in patients with asthma, on inhaled corticosteroids. During the screening period,
      all patients will take their own baseline inhaled corticosteroid for 2 weeks. Patients on
      long-acting β2-agonist/ inhaled corticosteroids will be switched over to the respective
      inhaled corticosteroid monocomponent. Patients will be provided salbutamol as rescue
      medication for use throughout the study. Abediterol is an investigational product in early
      stages of clinical development, therefore individual participants in the clinical studies may
      not have a clinical benefit, especially in view of alternative therapies (bronchodilators)
      being available for the treatment of asthma and COPD.
    

Intervention name(s): Abediterol 0.156 μg; Abediterol 2.5 μg; Abediterol 0.05 μg; Abediterol 0.156 μg; Abediterol 2.5 μg; Placebo
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Other
Intervention description(s): Dry powder for inhalation; Dry powder for inhalation; Pressurised metered-dose inhaler; Pressurised metered-dose inhaler; Pressurised metered-dose inhaler; Pressurised metered-dose inhaler and dry powder for inhalation.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Abediterol; Dry powder inhaler; Pressured metered-dose inhaler; Pharmacokinetic; Pharmacodynamic; Safety
Abraxane Therapy in Patients With Pancreatic Cancer Who Failed First-Line Gemcitabine Therapy
Condition: Pancreatic Cancer
MeSH terms: Pancreatic Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      RATIONALE: Drugs used in chemotherapy, such as paclitaxel albumin-stabilized nanoparticle
      formulation, work in different ways to stop the growth of tumor cells, either by killing the
      cells or by stopping them from dividing.

      PURPOSE: This phase II trial is studying how well paclitaxel albumin-stabilized nanoparticle
      formulation works in treating patients with locally advanced or metastatic pancreatic cancer
      that did not respond to first-line therapy with gemcitabine.
    

Detailed description: 
      OBJECTIVES:

      Primary

        -  To establish preliminary evidence of efficacy of paclitaxel albumin-stabilized
           nanoparticle formulation in patients with locally advanced (unresectable) or metastatic
           pancreatic cancer that failed first-line therapy with a gemcitabine
           hydrochloride-containing regimen.

      Secondary

        -  To determine the safety and characterize the toxicity profile of this drug.

        -  To determine the complete, partial, and overall response rates and duration of response
           in patients with measurable disease.

        -  To determine CA 19-9 response.

        -  To determine progression-free survival.

      OUTLINE: This is a multicenter study.

      Patients receive paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes on
      days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or
      unacceptable toxicity.

      After completion of study treatment, patients are followed every 3 months for 1 year and then
      annually thereafter.
    

Intervention name(s): Abraxane
Intervention type(s): Drug
Intervention description(s): One treatment-cycle is 28 days with chemotherapy (Abraxane® 100 mg/m2) given on day 1, 8, and 15, followed by rest on week 4. Treatment cycles will be repeated every 28 days for as long as disease is not progressing and patient tolerates treatment
Other intervention name(s): Paclitaxel Albumin-Stabilized Nanoparticle Formulation
Intervention MeSH terms: Paclitaxel; Albumin-Bound Paclitaxel
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: recurrent pancreatic cancer; stage III pancreatic cancer; stage IV pancreatic cancer
Pharmacokinetic and Tolerability Study of NFC-1 in Subjects Aged 6-17 Years With ADHD
Condition: Attention Deficit Disorder With Hyperactivity
MeSH terms: Hyperkinesis; Attention Deficit Disorder with Hyperactivity
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a open-label, single ascending dose, pharmacokinetic, and tolerability study of NFC-1
      in Children and Adolescents (Ages 6-17 Years) with ADHD.
    


Intervention name(s): NFC-1 100 mg; NFC-1 200 mg; NFC-1 400 mg; NFC-1 800 mg
Intervention type(s): Drug; Drug; Drug; Drug
Other intervention name(s): AEVI-001; MDGN-001; AEVI-001; MDGN-001; AEVI-001; MDGN-001; AEVI-001; MDGN-001
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Electrophysiological Properties of the Pulmonary Veins
Condition: Electrophysiology of Pulmonary Veins
Study type: Observational

Summary: 
      The pulmonary veins are the predominant sources of AF induction and maintenance. This study
      aims to assess the electrophysiological properties of the pulmonary veins and their relation
      to AF in humans.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        First review of the data base with respect to study outcome was performed after 35 enrolled
        patients. As a result, the results were already significant and the study was stopped
        prematurely.
Optimizing the Use of Prophylaxis in Patients With Severe Haemophilia A
Condition: Hemophilia A
MeSH terms: Hemophilia A
Study type: Interventional
Phase: Phase 4

Summary: 
      MyPKFiT is a web-based application recently developed by Baxalta for the use in patients
      treated with Advate. MyPkFit has its basis in Bayesian forecasting, which allows estimation
      of individual PK parameters by a sparse sampling schedule, where only 2-3 samples are taken
      between 4 and 48 hours post infusion. With myPKFiT, it will, therefore, be possible to define
      an individual PK curve for each patient based on just a few sampling points and hence, taking
      the bleeding phenotype and the life style into account, potentially adjust the prophylactic
      treatment accordingly to optimize cost-effectiveness.
    

Detailed description: 
      As detailed in brief summary patients will, after accurate information verbally and written
      according to ethics approval, report bleeding events during previous 6 months. Blood samples
      are taken, FVIII analyzed (Advate patients) and the individual PK curve determined using
      MyPKFit. The curve will be discussed together with the patient and levels related to bleed
      events determined. If needed dose adjustment is done based on the curve. After a further 6
      month follow-up bleeds will again be evaluated as well as factor consumption. In this way a
      better personalized treatment based on PK and clinical phenotype will hopefully be achieved.
    

Intervention name(s): Oktokog alpha
Intervention type(s): Drug
Intervention description(s): adjusting dose and dose interval according to MyPKFIT
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other