bioihbjkbjnl/mcl2 huggingface dataset:
Clinical Effects of Radiofrequency in Fibromyalgia
Condition: Fibromyalgia
MeSH terms: Fibromyalgia; Myofascial Pain Syndromes
Study type: Interventional

Summary: 
      The aim of this study is to analyze the effects of a single-session of Radiofrequency in
      patients with Fibromyalgia in comparison to a placebo group.
    

Detailed description: 
      The aim of this study is to analyze the effects of a single-session of Radiofrequency on
      peripheral vascular blood flow of the skin of the hands and core body temperature in patients
      with Fibromyalgia in comparison to a placebo group. Also, to study the clinical effects of
      the intervention on subjective pain perception, pain threshold to pressure and electrical
      pain threshold and intensity.
    

Intervention name(s): Single-session of Radiofrequency; Control Placebo single-session of Radiofrequency
Intervention type(s): Device; Device
Intervention description(s): The experimental group continue with their usual conservative and pharmacological treatment and will receive a single-session of monopolar dielectric capacitive radiofrequency in their hands. An Biotronic Advance Develops® (ABD-S25v) with a carrier wave frequency of 800-900 KHz of 850 KHz will be used. Patients will be placed in a seated position, with the forearms supinated and resting on a wooden table. An almond oil conductor will be applied to the hands. The application will be carried out with a circular head of 5 cm2 and for a total of 10 minutes on each of the palms of the hands.
They will be evaluated at baseline and post-session.; The control placebo group continue with their usual conservative and pharmacological treatment and will receive a placebo single-session of radiofrequency. This group will follow the same protocol and treatment time, but they will receive a placebo treatment (the device remains in paused mode), so that radiofrequency will not be applied.
They will be evaluated at baseline and post-session.
Other intervention name(s): Electric Stimulation Therapy; Control Placebo Group
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Radiofrequency Therapy; Peripheral blow flow; Core body temperature; Pain; Central sensitization; Peripheral nervous system; Thermography
Assessing the Effects of a Nasal Corticosteroid on PMI-150 (Intranasal Ketamine)
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      To assess the effects of nasal corticosteroid treatment on the rate and extent of intranasal
      absorption of PMI-150 (intranasal ketamine HCl)
    

Detailed description: 
      Subjects will participate in a two-period, single-sequence study to assess the effects of
      administration of a nasal corticosteroid, Nasonex (mometasone furoate), on the
      pharmacokinetics, safety and tolerability of PMI-150 (intranasal ketamine HCl) in healthy
      adult volunteers.
    

Intervention name(s): PMI-150 (intranasal ketamine HCl); mometasone furoate
Intervention type(s): Drug
Intervention description(s): 1 dose PMI-150 (intranasal ketamine HCl); day 1
mometasone furoate, daily; days 2-15
1 dose PMI-150 (intranasal ketamine HCl); day 15
Other intervention name(s): Nasonex
Intervention MeSH terms: Mometasone Furoate; Ketamine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Keywords: ketamine; corticosteroid; intranasal; phase I; Healthy volunteers
Impact of Behavioral Feeding Intervention on Parent-Child Attachment in Young Children
Condition: Pediatric Feeding Disorders
MeSH terms: Feeding and Eating Disorders
Study type: Interventional
Phase: Phase 4

Summary: 
      The primary objective of the proposed study is to determine whether behavioral feeding
      intervention impacts mother-child attachment in infants and toddlers with feeding problems.
      The investigators propose the following hypotheses:

        -  Behavioral feeding intervention will not significantly impact parent-child attachment.

        -  Behavioral feeding intervention will not significantly impact parent-child unstructured
           play interactions.

        -  Severity of feeding problems will decrease after behavioral feeding intervention is
           implemented.

        -  Behavioral feeding intervention will have either no significant effect or a significant
           positive effect on general child behavior.
    


Intervention name(s): Behavioral feeding intervention
Intervention type(s): Behavioral
Intervention description(s): Behavioral feeding intervention will include escape extinction.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Before-after Comparison of Pharmacist Drug Therapy Management in Pediatric Hypertension
Condition: Hypertension; Blood Pressure
MeSH terms: Hypertension
Study type: Interventional

Summary: 
      This study will measure the effect of a novel pharmacy practice model on pediatric patients
      with hypertension. In North Louisiana, many patients have to travel to see subspecialists for
      treatment for hypertension and elevated blood pressure, which has many costs including direct
      medical costs, direct nonmedical costs, and indirect costs like missed time from work,
      school, or social obligations. Also, many patients who have to travel to get to their
      appointments have a high rate of missed appointments, which can be bad for overall health.

      This study will use a pharmacist to perform collaborative drug therapy management with
      pediatric cardiologists to manage therapy for patients with hypertension or elevated blood
      pressure. Patients will monitor blood pressure at home and follow up with the pharmacist by
      telecommunications. Pharmacist drug therapy management and telemedicine have been studied
      separately, but this is the first study with pharmacist drug therapy management by
      telemedicine for pediatric patients. If this model is successful, it could be replicated in
      other rural areas to improve patient care and reduce healthcare costs.
    


Intervention name(s): Pharmacist Drug Therapy Management
Intervention type(s): Other
Intervention description(s): Patients will be seen by pharmacist for collaborative drug therapy management.
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Intervention model description: Before-after comparison of intervention to traditional care
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: Children; Adolescents; Young Adults; Pediatric Hypertension; Pharmacoeconomics; Pharmacist
A Trial Evaluating the Effect of NN1250 at Steady State Conditions in Subjects With Type 1 Diabetes
Condition: Diabetes; Diabetes Mellitus, Type 1
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Phase 1

Summary: 
      This trial was conducted in Europe. The aim of this clinical trial was to evaluate the effect
      on the blood glucose-lowering effect of NN1250 (insulin degludec) in subjects with type 1
      diabetes.
    


Intervention name(s): insulin degludec; insulin glargine
Intervention type(s): Drug; Drug
Intervention description(s): Subjects were randomised to one of three possible dose levels (low, middle or high) and to one of two treatment sequences. A treatment sequence consisted of 2 periods of each 13 days. One dose once daily. The trial products were administered subcutaneously (under the skin); Subjects were randomised to one of three possible dose levels (low, middle or high) and to one of two treatment sequences. A treatment sequence consisted of 2 periods of each 13 days. One dose once daily. The trial products were administered subcutaneously (under the skin)
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Insulin Glargine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
A Comparison of Zidovudine Plus Lamivudine Versus ddI Used Alone or in Combination With Zidovudine in HIV-1 Infected Children
Condition: HIV Infections
MeSH terms: HIV Infections
Study type: Interventional
Phase: Phase 2

Summary: 
      To compare the efficacy of lamivudine (3TC) and zidovudine (AZT) in combination versus the
      better of didanosine (ddI) monotherapy or ddI/AZT combination, in symptomatic HIV-1 infected
      children who received less than 56 days of prior antiretroviral therapy. To evaluate the
      safety and tolerance of 3TC/AZT in this patient population. To determine other measures of
      diseases in response to the study regimens.

      Currently, none of the potential treatments for HIV-1 infection has proven to be both
      nontoxic and effective in long-term use. However, previous studies in both adults and
      children have shown that 3TC combined with AZT reduced HIV load in blood and increased white
      blood cells. Additionally, 3TC has demonstrated a favorable safety profile.
    

Detailed description: 
      Currently, none of the potential treatments for HIV-1 infection has proven to be both
      nontoxic and effective in long-term use. However, previous studies in both adults and
      children have shown that 3TC combined with AZT reduced HIV load in blood and increased white
      blood cells. Additionally, 3TC has demonstrated a favorable safety profile.

      Patients are randomized to receive oral 3TC/AZT, ddI/AZT, or ddI alone for at least 24
      months. PER AMENDMENT 4/29/96: NOTE: Randomization to ZDV+ddI arm was terminated in Spring of
      1996 based upon the results of ACTG 152. Patients on that arm will continue on blinded study
      drug and will be followed until the end of the study.
    

Intervention name(s): Lamivudine; Zidovudine; Didanosine
Intervention type(s): Drug; Drug; Drug
Intervention MeSH terms: Lamivudine; Zidovudine; Didanosine
Masking: Double
Primary purpose: Treatment
Keywords: Didanosine; Drug Therapy, Combination; Acquired Immunodeficiency Syndrome; AIDS-Related Complex; Zidovudine; Lamivudine
TO ASSESS THE EFFICACY AND SAFETY OF PF-06650833, PF-06651600, AND TOFACITINIB ALONE AND IN COMBINATION IN PARTICIPANTS WITH ACTIVE RHEUMATOID ARTHRITIS WITH AN INADEQUATE RESPONSE TO METHOTREXATE
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Interventional
Phase: Phase 2

Summary: 
      Dual objectives of increased efficacy compared to currently available SoC RA drugs and
      maintaining a favourable benefit - risk relationship.
    


Intervention name(s): PF-06650833; PF-06651600; Tofacitinib
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 400 mg; 100 mg; 11 mg
Intervention MeSH terms: Tofacitinib
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Rheumatoid Arthritis
To Investigate the Efficacy and Safety of Individualized Doses of BioChaperone Insulin Lispro in Comparison to Humalog® U-100 in Patients With Type 1 Diabetes Mellitus
Condition: Type 1 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a double-blind, randomised, controlled, two period crossover phase Ib trial using an
      individualized standard meal with a fixed nutrient ratio in subjects with type 1 diabetes
      mellitus to investigate postprandial blood glucose control with BioChaperone insulin lispro
      compared to Humalog®. The assessments will be conducted before and after a period of multiple
      daily dose administrations for 14 days. The meal tolerance test will be performed on day 1-3
      and on day 14 of each period. Furthermore the study aims at investigating Post-prandial
      glucose (PPG) profiles with BioChaperone insulin lispro and Humalog® when injected at various
      injection meal intervals (-15min, 0 minutes, +15 minutes).

      Each subject will be randomised to a sequence of two treatments, either BioChaperone insulin
      lispro-Humalog® or Humalog®-Biochaperone insulin lispro, and three different sequences of
      injection-meal intervals. A blinded to patient continuous monitoring of glucose (CGM) will be
      performed during the 14 day treatment periods.
    


Intervention name(s): BioChaperone insulin lispro; Humalog®
Intervention type(s): Drug; Drug
Intervention description(s): Injection at t0,or t+15 minutes or t-15minutes with test meal; Injection at t0,or t+15 minutes or t-15minutes with test meal
Intervention MeSH terms: Insulin Lispro
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Feasibility Randomized Trial for an Intensive Memory-Focused Training Program for School Aged Children With Acquired br.Inj.
Condition: Acquired Brain Injury
MeSH terms: Brain Injuries
Study type: Interventional

Summary: 
      Memory deficits are common sequelae of pediatric Acquired Brain Injury (ABI). Only methods
      for non-focused cognitive remediation are available to the pediatric field. The aims of this
      feasibility trial are the description, implementation, and test of an intensive program
      specific to the training and re-adaptation of memory function in children (IM-FTP). Method:
      Eleven children and adolescents with ABI (mean age at injury=12.2 years, brain tumor
      survivors excluded) were clinically assessed and rehabilitated over 1-month through IM-FTP,
      including physio-kinesis/occupational, speech, and neuropsychology treatments. Each patient
      received a psychometric evaluation and a brain functional MRI at enrollment and at discharge.
      Ten pediatric controls with ABI (mean age at injury=13.8 years) were clinically assessed, and
      rehabilitated through a standard program.
    


Intervention name(s): rehabilitation; Intensive Memory-Focused Training Program (IM-FTP)
Intervention type(s): Other; Other
Intervention description(s): the rehabilitation program consisted of an intensive treatment lasting 4 weeks, and including 3 daily interventions each working day (5 working days per week, for a total of 20 days of treatment and 60 sessions). The 3 daily sessions were organized as follows:
1 physio-kinesis and/or occupational therapy, 1 speech therapy, and 1 neuro-psychology treatment.
Each session lasted 45 minutes.; During each session, the patient was engaged in a one-to-one interaction with the therapist. Overall, the treatment targeted the following memory subfunctions: verbal and visuo-spatial short-term memory, verbal and visuo-spatial long-term memory, working memory and procedural memory
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: an intensive program specific to the training and re-adaptation of memory function in children versus standard rehabilitation
Masking: None (Open Label)
Primary purpose: Treatment
Portable Visual Guidance System Phase II
Condition: Asperger Syndrome; High Functioning Autism
MeSH terms: Asperger Syndrome
Study type: Interventional

Summary: 
      Abstract: In Phase I, we designed and tested a Portable Visual Guidance System (PVGS), which
      combines a PDA - for user guidance - and an Internet website - for linking the user to an
      educational support team. Use of the PVGS 1) significantly improved the in vivo social
      pragmatics of students diagnosed with Aspergers Syndrome/Higher Functioning Autism (AS/HFA);
      2) revealed additional ways of improving social pragmatics; and 3) improved activity
      management in scheduling and vocational tasks.

      In Phase II, we will focus on social pragmatics and two closely related skills: feelings
      management and assignment management. We aim to:

        1. Replicate Phase I success in the most educational setting for AS/HFA high school aged
           students: mainstream school inclusion classes.

        2. Replicate Phase I findings more efficiently, with a less highly trained, on-site
           coaching staff and with more distant (non-site) expert supervision of that staff.

        3. Contrast the outcomes of the curriculum with a diagnosis-matched wait-list control
           group.

        4. Develop and implement software that will enable on-site staff to create and modify
           individualized guidance and monitoring screens as needs arise.

        5. Design a commercially attractive package of software, video training, video-conferenced
           support, and manuals.

        6. Complete the translation of the SymTrend website and all the above tools into Spanish.

      Significance: Successful completion of Phase II will:

        1. Provide a very effective and comprehensive system for teaching social pragmatics and
           related management skills to AS/HFA persons in an inclusion context.

        2. Provide a means of evaluating IEP effectiveness, thereby enabling a better use of
           special education funds and a reduction of litigation over IEP plan appropriateness and
           utility.

        3. Provide substantial support for our theoretical rationale for curriculum building in
           Special Education - a rationale that can guide the formulation of IEPs.

        4. Provide a theoretical rationale, an intervention framework, and intervention support
           technology that can be extended to cognitive behavioral treatment of other
           neuropsychiatric disorders and can be adapted for other forms of healthcare guidance.

        5. Provide an investigative system, as well as an intervention system, for tracking
           behavioral change in studies of frontal lobe and limbic neuroplasticity in
           neuropsychiatric disorders.
    


Intervention name(s): PVGS
Intervention type(s): Behavioral
Intervention description(s): Student use of SymTrend PVGS daily then tapering off for 14 weeks in conjunction to ratings by a coach.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Hepatitis C Rimantadine and Antiviral Combination Therapy
Condition: Hepatitis C
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis
Study type: Observational

Summary: 
      Hepatitis C virus is one of the leading causes of liver failure and liver cancer worldwide.
      Current treatment of hepatitis C infection is only successful in about half of those who are
      eligible. The current treatment aims to boost the host immune system but does not directly
      act on the virus. Many drugs are in various stages of development that target the virus
      directly - their specific mode of action is confirmed by showing the virus is forced to adapt
      in the presence of the drug. As with many viruses, treating with only one specific drug would
      quickly lead to the virus adapting and becoming resistant. We therefore need to find new
      combinations of directly acting drugs. Rimantadine has already been shown in the laboratory
      to target hepatitis C directly. We have designed this study to see if it happens in real life
      as well. If so, we could use rimantadine to help fight hepatitis c more effectively.
    


Intervention name(s): rimantadine
Intervention type(s): Drug
Intervention description(s): 12 weeks of rimantadine therapy in addition to standard combination therapy with interferon and ribavirin
Intervention MeSH terms: Rimantadine
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        patients with hepatitis c virus infection who are attending the department of hepatology
        for treatment with standard combination therpay
      
Biospecimen description: 
      blood samples of patients undegoing standard combination therpay for hepatits c virus
      infection
    
Keywords: hepatitis C virus; Interferon; rimantadine; liver
A Trial of CM-AT in Children With Autism- Open Label Extension Study
Condition: Autism
MeSH terms: Autistic Disorder
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to determine whether CM-AT is effective in treating the core
      symptoms of autism.
    

Detailed description: 
      Autism is currently a significant cause of disability in the pediatric population. CM-AT is
      based upon the observation that many children with autism do not digest protein. CM-AT is a
      proprietary enzyme that is designed as a powder taken three times a day. It is formulated to
      be released in the small intestine to enhance protein digestion thus increasing the
      availability of essential amino acids.
    

Intervention name(s): CM-AT
Intervention type(s): Drug
Intervention description(s): Single unit dose powder of active substance (CM-AT) administered 3 times per day for 90 days
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Autism
Phase 2, Randomized, Double Blind, Placebo Controlled Multicenter Study of Autologous MSC-NTF Cells in Patients With ALS
Condition: Amyotrophic Lateral Sclerosis (ALS)
MeSH terms: Motor Neuron Disease; Amyotrophic Lateral Sclerosis
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a multi-center, randomized, double blind, placebo controlled study to evaluate the
      safety and efficacy of autologous (self) transplantation of Neurotrophic factors-secreting
      Mesenchymal Stromal Cells (MSC-NTF, NurOwn™) in patients with ALS .

      MSC-NTF cells are a novel cell-therapeutic approach which is expected to effectively deliver
      Neurotrophic factors, which are potent survival factors for neurons, directly to the site of
      damage.
    

Detailed description: 
      The MSC-NTF cell therapy (NurOwn™) is based on transplantation of autologous bone marrow
      derived mesenchymal stromal cells (MSC), which are enriched from the patients' own bone
      marrow, propagated ex vivo and induced to secrete NTFs. The autologous MSC-NTF cells are
      back-transplanted into the ALS patient into the sites of damage, the spinal cord and the
      muscles.

      NTFs are potent survival factors for embryonic, neonatal, and adult neurons and are
      considered potential therapeutic candidates for ALS. Delivery of appropriate NTFs to the
      immediate environment of afflicted neurons in ALS patients is expected to improve their
      survival and thus slow down disease progression and alleviate symptoms.

      Previous open-label clinical trials have shown that MSC-NTF cells treatment was well
      tolerated and appears to be generally safe. Some initials indications of clinical benefit
      were also observed in some patients.

      This multi-center, randomized, double blind, placebo controlled study will evaluate the
      safety and efficacy of a single combined intramuscular and intrathecal administration of
      MSC-NTF cells in early-stage ALS patients. Patients will be followed for approximately three
      months before transplantation with their autologous MSC-NTF cells or placebo. During this
      period of time, patient bone-marrow will be harvested and mesenchymal stromal cells will be
      isolated and expanded. Following treatment patients will be followed for a total of six
      months at monthly visits.
    

Intervention name(s): Autologous MSC-NTF cells; Placebo
Intervention type(s): Biological; Biological
Intervention description(s): Single autologous MSC-NTF cells treatment by combined intramuscular and intrathecal administration; Excipient administration by combined intramuscular and intrathecal administration
Other intervention name(s): NurOwn
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Mesenchymal Stromal cells; MSC-NTF; Cell therapy; ALS