bioihbjkbjnl/mcl2 huggingface dataset:
Family Assisted Severe Febrile Illness Therapy for Critically-ill Kenyan Children
Condition: Critical Illness; Febrile Illness
MeSH terms: Critical Illness; Hyperthermia; Fever
Study type: Interventional

Summary: 
      The purpose of this pilot study is to improve inpatient monitoring of severely-ill children
      admitted to the hospital in low resource settings at Kenyatta National Hospital in Nairobi,
      Kenya. Given the high ratio of patients to medical staff in these settings, the lack of
      reliable patient monitoring tools, and the high rate of early inpatient mortality, we will
      prospectively train parents as monitoring aids of their hospitalized children. Early
      recognition and intervention in critical illness is important to avoid (further) organ
      failure. Parents will be taught how to assess their child's mental status, work of breathing
      and capillary refill time which will inform a 3-point severity of illness scale. The severity
      of illness will be conveyed by the parents to the medical staff via color-coded flag system.
      The goal is to increase the healthcare provider patient reassessment rate according to
      patients' level of severity to assist in early recognition and treatment of patients'
      deterioration.
    


Intervention name(s): FASTER Assessment tool
Intervention type(s): Other
Intervention description(s): The FASTER assessment tool consists of monitoring mental status, respiratory distress and capillary refill time by parents of children admitted to the hospital with febrile illness. Parents in the intervention group are asked to monitor their child hourly with the FASTER tool and signal severity of illness to the healthcare team via color coded flag system. Number of healthcare provider - patient reassessments will be compared in intervention and control group.
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Low and Middle Income Countries; Limited resource settings; Early warning signs
Brain Dopamine Function in Adults With ADHD
Condition: Attention Deficit Hyperactivity Disorder
MeSH terms: Attention Deficit Disorder with Hyperactivity
Study type: Interventional

Summary: 
      The purpose of the study is to investigate the functional state of dopamine cells and the
      dopamine transporter in ADHD subjects and controls to assess the effects of chronic
      methylphenidate treatment on dopamine cell function and dopamine transporter levels in ADHD
      subjects.
    


Intervention name(s): Methylphenidate
Intervention type(s): Drug
Intervention description(s): Methylphenidate
Intervention MeSH terms: Methylphenidate
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Brookhaven; ADHD; Dopamine; methylphenidate; PET
The Impact of Transcutaneous Spinal Cord Stimulation (TSCS) and Gait Training on Walking Function in Patients With Spinal Cord Injury
Condition: Spinal Cord Injuries
MeSH terms: Spinal Cord Injuries; Wounds and Injuries
Study type: Interventional

Summary: 
      Aim 1: Determine the neurophysiologic impact of Transcutaneous Spinal Cord Stimulation (TSCS)
      within a single session. The investigators hypothesize that subjects will demonstrate
      increased volitional muscle activity and strength with TSCS. This will be assessed by surface
      EMG and hand-held dynamometry of the dominant-side quadriceps muscle during maximum
      volitional contraction (MVC) and measurement of gait speed. Subjects will be tested in both
      TSCS and sham conditions.

      Aim 2: Determine the impact of TSCS and gait training on walking function. The investigators
      hypothesize that concurrent TSCS and gait training will augment walking function in subjects
      with iSCI, as compared to gait training alone. Subjects will participate in an eight-week
      program of gait training with TSCS and be assessed with clinically relevant outcome measures,
      to include the Timed Up and Go, 10-Meter Walk Test, Walking Index for Spinal Cord Injury II,
      and 6-Minute Walk Test.
    


Intervention name(s): Transcutaneous Spinal Cord Stimulation and Gait Training
Intervention type(s): Other
Intervention description(s): TSCS will be applied using a midline electrode placed on the skin between spinous process T11 -T12 and two electrodes placed symmetrically on the skin over the lower abdomen as anodes. A symmetrical biphasic rectangular waveform, at 50 Hz and 1 millisecond, is used to provide 30 continuous minutes of stimulation.
Subjects will participate in 24 two-hour sessions of physical therapy over eight weeks. In each session, subjects will receive TSCS continuously for 30 minutes, using the parameters outlined above. During stimulation, subjects will participate in strengthening, segmental task practice, and gait-based interventions. Participation in gait training will continue following the stimulation period for the duration of the session.
Intervention model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Role of Fexofenadine in Diabetic Kidney Disease
Condition: Diabetic Kidney Disease
MeSH terms: Kidney Diseases; Diabetic Nephropathies
Study type: Interventional
Phase: Phase 3

Summary: 
      -  This study will that will be conducted on 60 outpatients previously diagnosed with type
           2 diabetes mellitus.

        -  Patients will be recruited from Internal Medicine Department, Tanta University Hospital,
           Tanta, Egypt.

      This study will be randomized, controlled, parallel, prospective clinical study. Accepted
      patients will be randomized into 2 groups as the following

        -  Group 1 (Control group): 30 patients will receive maximum tolerated dose of ACEI for six
           months

        -  Group 2 (Fexofenadine group): 30 patients will receive maximum tolerated dose of ACEI
           plus fexofenadine tablets 60 mg once daily for six months

      The primary end point will be the change in Urinary albumin to creatinine ratio (UACR) after
      six months of treatment
    


Intervention name(s): Fexofenadine Pill; Placebo oral tablet
Intervention type(s): Drug; Drug
Intervention description(s): fexofenadine tablets 60 mg once daily will be taken for six months; lactose oral tablet
Intervention MeSH terms: Fexofenadine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Evaluation of the Modified Atkins Diet in Young Children With Refractory Epilepsy
Condition: Refractory Epilepsy
MeSH terms: Epilepsy; Drug Resistant Epilepsy
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The modified Atkins diet is a non-pharmacologic therapy for intractable childhood epilepsy
      that was designed to be a less restrictive alternative to the traditional ketogenic diet.
      This diet is started on an outpatient basis without a fast, allows unlimited protein and fat,
      and does not restrict calories or fluids. Modified Atkins diet is of special importance in
      resource constraint settings with paucity of trained dieticians. However, there is paucity
      published data on the use of the modified Atkins diet in refractory epilepsy in young
      children. This study aims to evaluate the efficacy and tolerability of the modified Atkins
      diet in refractory epilepsy in young children.
    


Intervention name(s): Modified Atkin Diet
Intervention type(s): Other
Intervention description(s): Eligible children will be started on Modified Atkins diet with help of trained dietician. Carbohydrates intake will be restricted to 5 grams/ day in children<18 mo and 10grams/day in children 18mo- 3 years.Carbohydrate values of various food items will be explained in detail. Fats (e.g. cream, butter, oils, and ghee) will be encouraged. Proteins (cheese, fish, eggs, chicken, and soya products) will be unrestricted. Calcium and multivitamin supplementation will be done. Syrups will be restricted. Clear carbohydrates free fluids- will not be restricted. Medications will be changed to carbohydrate free preparations, wherever available. Diary of events will be recorded including seizure frequency and any adverse or positive effect. Urine ketones chart will be maintained.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Refractory epilepsy; dietary therapy; non-pharmacological therapy; Modified Atkin Diet
The Correlations Between Early Enteral Nutrition and Intra-abdominal Pressure in Severe Acute Pancreatitis
Condition: Acute Pancreatitis; Intra-abdominal Hypertension
MeSH terms: Intra-Abdominal Hypertension; Pancreatitis
Study type: Interventional
Phase: Phase 4

Summary: 
      As an important management of severe acute pancreatitis (SAP), enteral nutrition (EN),
      especially early enteral nutrition (EEN) increases the blood flow of gut mucosa and
      stimulates the intestinal motility. Moreover, EEN maintains the gut integrity, prevents
      bacterial and endotoxin translocation and thereby theoretically reduces the incidence of
      infections. Therefore, EEN has the ability to reduce the infectious complications, length of
      hospital stay and mortality of patients with SAP.

      However, the role of EEN is considered to be influenced by intra-abdominal hypertension (IAH)
      in patients with SAP. The previous studies showed that gut was the most sensitive splanchnic
      organ to the increase of intra-abdominal pressure (IAP). When IAH occurs, it reduces the
      blood flow of gut, and then results in the development of intestinal ischemia and edema. The
      hypoxia and hypoperfusion of intestine leads to the increase of permeability of the
      intestinal mucosal barrier, and then leads to bacterial translocation. Therefore, IAH could
      result in the gastrointestinal dysfunction. Nevertheless, the different impacts of specific
      IAP values on the tolerance of EEN have not been reported.

      Furthermore, the effects of early enteral feeding on the IAP in SAP also remain unknown. Due
      to the severe inflammatory response of SAP, could EEN increase the burden of bowel, cause
      expansion of intestinal cavity, thus increase IAP? However, there were rare literatures up to
      date reporting the association between EEN and IAH in patients with SAP. Therefore, the
      present study aimed to investigate the influence of specific IAP on the tolerance of early
      enteral feeding, as well as the effects of EEN on IAP in SAP patients. Moreover, the impacts
      of EEN on the disease severity and clinical outcome of SAP were also researched.
    


Intervention name(s): early enteral nutrition; Delayed enteral nutrition
Intervention type(s): Drug; Drug
Intervention description(s): The enteral nutrition was started within 48h after admission; The enteral nutrition was started at the 8th day after admission
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: severe acute pancreatitis; intra-abdominal pressure; enteral nutrition
The Role of the Cervical Spine in Carpal Tunnel Syndrome
Condition: Carpal Tunnel Syndromes
MeSH terms: Carpal Tunnel Syndrome; Syndrome
Study type: Interventional

Summary: 
      This randomized clinical trial will investigate changes in hand function, active cervical
      range of motion and pinch grip force after the application of physical therapy in women with
      carpal tunnel syndrome (CTS). The purpose of this study is to compare changes in function,
      cervical range of motion and pinch grip force induced after the application of a physical
      therapy program including manual therapies targeted to those areas related to the median
      nerve or after endoscopic surgery in women with CTS at medium and long-term follow-up. The
      hypothesis is that manual therapy is more effective for increasing cervical range of motion
      and pinch grip force, but similarly effective for improving function, than surgical treatment
      in women with CTS.
    

Detailed description: 
      There is some evidence suggesting that CTS is associated with restricted cervical range of
      motion and deficits in pinch grip force. In fact, restricted cervical range of motion and
      deficits in pinch grip force seems to be independent of electro-diagnostic findings. These
      findings would be associated with the proposed "double crush syndrome" theory. However no
      longitudinal studies have been conducted. Further it has been demonstrated that hand function
      is associated to deficits in these outcomes. Since previous studies support the use of
      physical therapy and surgical interventions for the management of function in these patients,
      the aim of this study is to conduct a randomized clinical trial to determine if changes in
      hand function are related to changes in active cervical range of motion and pinch grip force
      after the application of a physical therapy program including manual therapies targeted to
      those areas related to the median nerve or endoscopic surgery in women with CTS.
    

Intervention name(s): Physical Therapy Group; Surgical Group
Intervention type(s): Other; Procedure
Intervention description(s): The physical therapy group will receive 3 treatment sessions of manual therapies including maneuvers targeted to the areas anatomically related to the median nerve (i.e., cervical spine, shoulder, elbow and wrist) of 30min of duration, once per week.; The surgical group will receive a surgical procedure consisting of the decompression and release of the median nerve at the carpal tunnel performed by an experienced surgeon according to standardized protocols.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
A Study to Assess the Safety and Tolerability of E8001 in Healthy Male Participants
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics (PK)
      of E8001 of single ascending dose intravenous infusions in healthy male participants.
    


Intervention name(s): E8001; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Intravenous infusion.; Intravenous infusion.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Other
Keywords: Healthy Participants; E8001
Study of the Electrocardiographic Effects of TA-8995
Condition: Dyslipidaemia
MeSH terms: Dyslipidemias
Study type: Interventional
Phase: Phase 1

Summary: 
      A study in healthy males and females to see if a high single dose of TA-8995 has an effect on
      the ECG QTcF interval.
    


Intervention name(s): TA-8995; Moxifloxacin; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention MeSH terms: Moxifloxacin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Etiology of Uncomplicated Fever in Children <5 in Rural Zanzibar
Condition: Fever; Infectious Disease
MeSH terms: Communicable Diseases; Infections; Fever
Study type: Observational

Summary: 
      The purpose of this study is to study the most common etiologies of uncomplicated fever
      diseases among children under five years of age in rural Zanzibar.
    

Detailed description: 
      During the last 6 years Zanzibar has undergone a dramatic change in malaria epidemiology and
      burden of disease, with a marked decline of Plasmodium falciparum malaria among febrile
      children from approximately 30% to 1% or below and a reduction of crude child mortality of
      50%. Millions of children in Africa die of neonatal disorders, acute respiratory tract
      infections (ARI), diarrhea, malaria, measles, HIV and malnutrition. A majority of these
      illnesses are also a common cause of febrile illness in out-patient departments. However,
      most of the few fever studies made in Africa are hospital based Very few studies on etiology
      of childhood febrile disease have been conducted on first level health facilities in the
      least developed countries in Africa. This study will therefore focus on children between 2
      months to 5 years of age that have been diagnosed with a negative rapid diagnostic test (RDT)
      for malaria and their causes of fever at the first referral level in out-patient clinics in
      Zanzibar.
    

Observational model: Cohort
Sampling method: Non-Probability Sample
Study population: 
        Kivunge Primary Health Care Center (PHCC) in North A District in Zanzibar
      
Biospecimen description: 
      Urine collected in deep ager Frozen Nasopharyngeal secretions
    
Keywords: Fever; Etiology; Children under five years of age; IMCI
Enoxacin for Amyotrophic Lateral Sclerosis (ALS)
Condition: Amyotrophic Lateral Sclerosis
MeSH terms: Motor Neuron Disease; Amyotrophic Lateral Sclerosis; Sclerosis
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The study will assess the safety of the drug enoxacin at specific dose levels in adults with
      ALS.
    

Detailed description: 
      Participants will be randomized to one of three doses of enoxacin (200, 400, or 600mg twice
      daily) for 30 days. On day 1, 7, 14, 21, and 30 of treatment and at a follow-up visit 14 days
      after the last dose, participants will be assessed for safety measures and blood will be
      collected to assist with the determination of enoxacin pharmacokinetics (PK) and
      pharmacodynamics (PD). On day 1 and day 30 of dosing, participants will only take one dose of
      study medication (the morning dose) to assist with determination of enoxacin single dose PK
      over a 24-hour period. A lumbar puncture (LP) to collect cerebrospinal fluid (CSF) for PD
      assessments will occur on day 1 and day 30.
    

Intervention name(s): Enoxacin; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Oral 200mg tablet; Oral tablet
Intervention MeSH terms: Enoxacin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Enoxacin
Effect of Nefazodone on Relapse in Females With Cocaine Abuse - 10
Condition: Cocaine-Related Disorders
MeSH terms: Cocaine-Related Disorders
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to determine the effect of nefazodone on relapse to cocaine use
      in depressed and non-depressed females with cocaine abuse/dependence.
    

Detailed description: 
      The purpose of this study is to determine the effect of nefazodone on relapse to cocaine in
      women and if a greater effect will be seen in the dependent condition. A relapse and coping
      skills questionnaire will be utilized to determine the various factors important to the
      relapse process.
    

Intervention name(s): Nefazodone
Intervention type(s): Drug
Intervention MeSH terms: Nefazodone
Masking: Double
Primary purpose: Treatment
Keywords: cocaine dependence
Nanogen Pegfilgrastim (Pegcyte) PK/PD Clinical Study in Breast Cancer Patients
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      Breast cancer patients scheduled to receive myelosuppressive chemotherapy (AC regimen) will
      be enrolled in this study. Eligible patients receive single SC injection of pegcyte or
      neulastim 24 hours after administration of chemotherapy (Doxorubicin and Cyclophosphamide) in
      the first cycle (14 days each cycle). Blood samples are collected to determine the serum
      concentration of investigational drugs at specific time points in the first cycle. Absolute
      neutrophil count, CD34+ count, Cmax (maximum serum concentration), AUC0-t (area under the
      curve of the plasma concentration time) and Tmax (time required to reach Cmax) will be
      calculated from the serum concentration profile
    


Intervention name(s): Pegfilgrastim
Intervention type(s): Drug
Intervention description(s): PK,PD and safety assessment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Thai MSM/TG Test and Treat Study
Condition: HIV Testing Rate; Acceptance of Immediate ART
Study type: Observational [Patient Registry]

Summary: 
      Objectives

        1. To determine the uptake of universal HIV testing among Thai men who have sex with men
           (MSM) and transgender women (TG)

        2. To determine the uptake of antiretroviral treatment (ART) regardless of CD4 count among
           Thai MSM/TG who test positive for HIV

      Subject population:. Men or transgender women who have sex with men,Thai nationals, age ≥18
      years old, Have engaged in anal intercourse with a man without using a condom at least one
      time in the last 6 months or have had at least 3 male sex partners in the last 6 months,Not
      known to be HIV-positive (either have never been tested for HIV or have had a previous
      negative HIV test)

      Number of participants:2000 Thai MSM and TG with approximately 76%-90% in Bangkok, 5%-12% in
      Lampang and 5-12% in Ubonratchathani.
    

Detailed description: 
      All participants will receive HIV testing at baseline. The frequency of study visits to
      determine HIV status in HIV-negative participants will be every 6 months for a total follow
      up time of 24 months. Once HIV-positive status is confirmed, participants will be offered ART
      immediately regardless of CD4 count. Those who accept ART will be seen more frequently
      following ART initiation, at 2 weeks, 4 weeks, 2 months, 3 months and every 3 months
      thereafter until completion of 24 months of follow-up. Those who deny immediate ART will have
      clinic visits every 6 months to monitor HIV disease. HIV-negative participants will be asked
      to come for HIV re-testing every 6 months or sooner if they feel exposed to risk
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        men who have sex with men and transgender women in Thailand
      
Keywords: 2000 MSM and TG sites in Bangkok,Lampang,Ubonratchathani
Effect of Prebiotic Fructans to Reduce Number of Febrile Infections in Children
Condition: Infectious Disease; Children, Only; Diet Modification
MeSH terms: Communicable Diseases; Infections
Study type: Interventional

Summary: 
      The study aims to confirm the effectiveness of chicory-derived prebiotic inulin-type fructans
      on the reduction of the number of febrile infections diagnosed by the paediatrician in
      children.
    


Intervention name(s): prebiotic inulin-type fructans; placebo maltodextrin
Intervention type(s): Dietary Supplement; Dietary Supplement
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention