bioihbjkbjnl/mcl2 huggingface dataset:
Speech Therapy and Repetitive Transcranial Magnetic Stimulation Therapy in Post-stroke Anomic Aphasia
Condition: Aphasia; Aphasia, Anomic; Stroke
MeSH terms: Stroke; Aphasia; Communication Disorders; Anomia
Study type: Interventional

Summary: 
      The aim of the study is to observe the effects of speech therapy and transcranial magnetic
      stimulation therapy in patients who develop anomic aphasia after stroke. Patients meeting the
      inclusion criteria will be randomly divided into groups. In the repetitive transcranial
      magnetic stimulation (rTMS) treatment group, a total of 10 sessions, 1 session per day, will
      be applied to the right inferior frontal gyrus area with a frequency of 1 Hz for 20 minutes.
      The control group patients will be given speech therapy in the same way, but no active
      magnetic stimulation will be given in rTMS sessions (sham application). Speech therapy will
      be given to each patient by the same physiotherapist, and the treatment will last a total of
      10 days, 60 minutes a day. Minimental test (MMT), Ege aphasia test, aphasia quality of life
      scale (SAQOL-39) will be filled in to the patients before and after the treatment.
    


Intervention name(s): Repetitive transcranial magnetic stimulation; Speech therapy
Intervention type(s): Device; Other
Intervention description(s): Transcranial Magnetic Stimulation(TMS) has been used for diagnostic and therapeutic purposes in the treatment of many neurological and psychiatric diseases such as stroke, multiple sclerosis, myelopathy, amyotrophic lateral sclerosis, movement disorders, epilepsy, and depression. It is a way to stimulate the targeted areas in the cerebral cortex without invasive methods. The application of TMS in the aphasia usually consists of repetitive stimulations, in order to activate or deactivate the target area.
In this study, 10 sessions of 1-Hz low frequency rTMS for 20 minutes will be applied to the inferior frontal gyrus of the right frontal lobe.; Speech therapy will be given to each patient by the same therapist, and the treatment will last 10 days, 60 minutes a day. It will consist of exercises to improve the articulation and comprehension.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
The Effect of Smoking on Thermoregulation
Condition: Cigarette Smoking
Study type: Interventional

Summary: 
      To the best of our knowledge, a possible relation between smoking and heat injuries or heat
      intolerance was never scientifically examined, although such a relation is logical according
      to the observations that smoking has a thermogenic effect, decreases physical fitness and
      affects the body's heat dissipation.16 healthy young male volunteers will participate in the
      study, 8 smokers and 8 non-smokers. They will arrive to our lab four or six times. They will
      perform VO2 test and heat tolerance test (HTT) in different conditions.
    

Detailed description: 
      16 healthy young male volunteers will participate in the study, 8 smokers and 8 non-smokers.
      They will arrive to our lab four or five times. During their first visit they will go through
      a VO2 max test in order to evaluate their aerobic fitness, and their physiological
      efficiency. During their second visit all subjects will go through the same test after
      exposure to nicotine. During the smokers' third visit they will go through the same test,
      after exposure to cigarette smoking. During the non-smokers third visit and the smokers
      fourth visit - they will go through an exercise heat tolerance test without prior smoking.
      During the fifth visit the smokers will go through an exercise heat tolerance test after
      exposure to cigarette smoking. During the smokers' sixth visit and the non-smokers fourth
      visit they will go through an HTT after exposure to nicotine.
    

Intervention name(s): Nicotine; cigarette smoking
Intervention type(s): Drug; Other
Intervention description(s): both groups will be given nicotine lozenges before a VO2 test and a HTT.; the smokers will smoke 2 cigarettes before a VO2 exam and a HTT.
Intervention MeSH terms: Nicotine
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: smoking; exercise; heat tolerance; heat stroke
Bioequivalence Study of Two Albiglutide Drug Products in Healthy Adult Subjects
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      Albiglutide (Alb) is a novel analogue of glucagon-like peptide-1 (GLP-1) has been developed
      and approved for the treatment of type 2 diabetes mellitus. Currently, lyophilized
      albiglutide and the diluent are provided in a dual chamber Cartridge (DCC) single-dose pen
      injector, requiring reconstitution prior to use. A liquid formulation of albiglutide will
      enable the use of a liquid product in a ready-to-use single dose auto-injector. To support
      the development of the liquid auto-injector product, this healthy volunteer bioequivalence
      study will be conducted to compare the liquid drug product to the currently available
      lyophilized product. This is Phase I, randomized, double-blind, double dummy, single-dose,
      2-period crossover study in healthy volunteers. This study will compare the pharmacokinetics
      and safety of the albiglutide 50 mg liquid drug product with the albiglutide 50 mg commercial
      lyophilized drug product.
    


Intervention name(s): Albiglutide Liquid Auto-injector; Albiglutide Lyophilized DCC Pen Injector; Placebo Liquid Auto-injector; Placebo Lyophilized DCC Pen injector
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Albiglutide liquid is provided as a fixed-dose, disposable auto-injector containing albiglutide liquid (50 mg). The auto-injector delivers the study treatment in an injection volume of 1.0 mL for the 50 mg dose; Albiglutide is supplied as prefilled DCC Pen Injector. Each DCC contains lyophilized albiglutide 50 mg. When the injector pen product is reconstituted a neutral, isotonic solution is produced. The pen delivers albiglutide in an injection volume of 0.5 mL; Liquid albiglutide matching placebo is provided as a fixed-dose, disposable autoinjector containing placebo liquid. The auto-injector delivers the placebo in an injection volume of 1.0 mL for the 50 mg placebo dose.; Placebo is supplied as prefilled DCC Pen Injector. Each DCC contains matching placebo. When the injector pen product is reconstituted a neutral, isotonic placebo solution is produced. The pen delivers the placebo in an injection volume of 0.5 mL.
Intervention MeSH terms: rGLP-1 protein; Glucagon-Like Peptide 1
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Albiglutide; Randomized; Pharmacokinetics; GSK716155; Bioequivalence study
RELAXaHEAD for Headache Patients (Phase I)
Condition: Headache; Migraine; Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Headache
Study type: Interventional

Summary: 
      The goal of this research is to assess the utility of smartphone-based progressive muscle
      relaxation (PMR) for the treatment of headaches. While there are many commercially available
      electronic diary and mind-body intervention apps for headache, there is little data showing
      their efficacy. RELAXaHEAD app incorporates the electronic PMR that was successfully used in
      an earlier epilepsy study and beta tested with headache specialist and migraine patient
      input. It also is an electric headache diary. This 2-arm randomized controlled study will
      evaluate the feasibility and acceptability of RELAX for use with headache patients. One arm
      will be the RELAX group (the RELAXaHEAD app) and the other arm will be a monitored usual care
      (MUC) group (this group receives standard of care and uses the electronic daily symptom
      reporting diary). The goals are to assess the feasibility and adherence of the RELAX
      intervention in persons with headache (Aim 1) and to gather exploratory data on the effects
      of the RELAX intervention on headache related outcome measures (Aim 2).
    


Intervention name(s): RELAXaHEAD app; Monitored Usual Care (MUC)
Intervention type(s): Behavioral; Behavioral
Intervention description(s): The Research Volunteers (RV) will explain the rationale for PMR and load the RELAXaHEAD app onto the patients' smartphones. The RV will review the app with the subject, focusing on user knowledge, usability, and engagement. The patient will perform a 15 minute session of PMR during the study enrollment and discuss the optimal time and place to practice PMR at home. Subjects will also be taught to enter their headache log daily on the app.; The Research Volunteers (RV) will load the app onto the patients' smartphones but the PMR component will be blocked on the version of the app that the MUC patients receive.
Subjects will be taught to enter their headache log daily on the app.
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Maternal Vit D Supplements & Infant and Maternal Biomarkers & Outcomes in Southern Ethiopia
Condition: Vitamin D Deficiency
MeSH terms: Vitamin D Deficiency
Study type: Interventional

Summary: 
      Synthesis of vitamin D in the skin through the action of sunlight is a major source of
      vitamin D in parts of the world where foods are not fortified with the vitamin. Skin
      pigmentation (color), dress habits and season are some of the factors that limit sun exposure
      and affect vitamin D synthesis in the skin. Maternal vitamin D status is especially important
      to meet infant needs when newborns are not supplemented with vitamin D. In Ethiopia, vitamin
      D status of lactating women and infants and breast milk vitamin D concentration have never
      been assessed. The purpose of this study is to assess changes in maternal and infant markers
      of vitamin D status before and after vitamin D supplementation of the lactating mothers.
    

Detailed description: 
      Vitamin D is a vitamin that regulates calcium and phosphorous homeostasis and ensures proper
      mineralization of bone. Lactating women and infants are considered to be at risk of vitamin D
      deficiency due to increased needs for vitamin D and calcium. Stores of vitamin D acquired in
      utero and breast milk are the main sources of vitamin D for infants. Maternal vitamin D
      deficiency, exclusive breastfeeding, skin pigmentation and limited sun exposure are commonly
      seen in infants with rickets. However, the UV exposure, dress habits, traditional practices
      and other risk factors to vitamin D deficiency in Ethiopia have not been explored. This study
      aims to fill this research gap.
    

Intervention name(s): Vitamin D
Intervention type(s): Dietary Supplement
Intervention description(s): Weekly oral supplementation with 15,000 IU vitamin D
Other intervention name(s): Vitamin D3
Intervention MeSH terms: Vitamin D; Ergocalciferols; Cholecalciferol; Vitamins
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: Vitamin D supplementation; Lactation; 25 hydroxyvitamin D; Breast feeding
UNN-RADS Scale for Diagnosing Lymph Node Metastasis in Patients With History of Thyroid Cancer
Condition: Thyroid Cancer; Lymph Node
MeSH terms: Neoplasm Metastasis; Thyroid Neoplasms; Lymphatic Metastasis; Thyroid Diseases
Study type: Observational [Patient Registry]

Summary: 
      In 2020, Sarda-Inman et al., developed the Ultrasound Neck Node Reporting and Data System
      (UNN-RADS) scale that allows decision-making about when it is appropriate to perform FNA of a
      cervical lymph node, evaluating seven ultrasonographic descriptors (shape, margins,
      echogenicity, echogenicity of the hilum, vascularity and the presence/absence of
      calcifications, and cystic degeneration), features that have been associated with metastatic
      lymph nodes, with scores ranging from 0 to 3 points, which allows categorize into 5 different
      risk groups. Thus, the objective of this study is to evaluate the ultrasound characteristics
      of metastatic LN in patients undergoing TC follow-up and to validate the UNN-RADS scale for
      the diagnosis of LN Metastasis in Patients with a history of TC.
    

Detailed description: 
      This study enrolled consecutive patients in follow-up for differentiated thyroid cancer (DTC)
      history who underwent US-guided fine needle aspiration (FNA) of the LNs for suspicious
      metastatic cervical lymph nodes. Patients were included if they 1) had previous history of
      DTC, 2) both sexes with age over 18 years old, and 3) underwent FNA of the LNs for any
      suspected features corresponding with at least UNN-RADS 1. Patients were excluded if they
      underwent FNA of the LNs for persistent or recurrent disease after surgery for thyroid
      cancer, had previous bilateral cervical lymph node dissection as initial treatment, or the
      FNA results were not concluded.

      UNN-RADS 1 y 2 and UNN-RADS 3, 4 and 5 were grouped for analysis purpose. Diagnostic
      performance of UNN-RADS scale were assessed in terms of sensitivity, specificity, positive
      predictive value (PPV) and negative predictive value (NPV), positive likelihood ratios (+LR),
      negative likelihood ratios (-LR) and accuracy, as well as with a receiver operating
      characteristic (ROC) curve.
    

Intervention name(s): US-guided fine needle aspiration (FNA)
Intervention type(s): Diagnostic Test
Intervention description(s): This study enrolled consecutive patients in follow-up for DTC history who underwent US-guided fine needle aspiration (FNA) of the LNs for suspicious metastatic cervical
Observational model: Cohort
Time perspective: Other
Sampling method: Non-Probability Sample
Study population: 
        Patients in follow-up for DTC history who underwent US-guided fine needle aspiration (FNA)
        of the LNs for suspicious metastatic cervical lymph nodes at Unidad Médica de Alta
        Especialidad HE 1 CMN Bajío
      
Keywords: Lymph node; Thyroid cancer; Ultrasonography; Metastasis
Single Low Dose Tafenoquine to Reduce P. Falciparum Transmission in Mali (NECTAR2)
Condition: Malaria, Falciparum
MeSH terms: Malaria, Falciparum
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to assess the gametocytocidal and transmission reducing activity
      of dihydroartemisinin-piperaquine (DP) with and without various low doses of tafenoquine (TQ;
      1.66mg/kg, 0.83mg/kg, or 0.415mg/kg). Outcome measures will include infectivity to mosquitoes
      at 2 and 7 days after treatment, gametocyte density throughout follow-up, and safety measures
      including haemoglobin density.
    

Detailed description: 
      Full protocol available on request.
    

Intervention name(s): Dihydroartemisinin/Piperaquine; Tafenoquine 100mg [Arakoda]
Intervention type(s): Drug; Drug
Intervention description(s): Tablets containing 40 mg dihydroartemisinin/320 mg piperaquine (Eurartesim, Sigma Tau), administered according to weight as per the manufacturer instructions.; Extemporaneous preparation of 1mg/mL Tafenoquine solution, from tablets containing 100mg primaquine (Arakoda, 60degrees pharmaceuticals, DC) dissolved in 100mL water with a non-interacting fruit-flavoured syrup. Solution will be given according to weight as indicated per treatment arm in 5kg bands.
Other intervention name(s): Euartesim; Arakoda
Intervention MeSH terms: Piperaquine; Artenimol; Tafenoquine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
The Effect of Perineural Injection Therapy in Patients With Carpal Tunnel Syndrome
Condition: Carpal Tunnel Syndrome
MeSH terms: Carpal Tunnel Syndrome; Syndrome
Study type: Interventional

Summary: 
      Carpal tunnel syndrome (CTS) is the most common peripheral entrapment neuropathy with
      involving compression of the median nerve in the carpal tunnel. Rather than other progressive
      disease, CTS is characterized by remission and recurrence. Although many conservative
      managements of CTS, the effectiveness of these methods is insignificant or only persist for a
      short duration. Recently, the ultrasound-guided perineural injection with 5% dextrose was
      widely used for entrapment neuropathy with positive benefit. However, current studies have
      not entirely proved the effects of perineural injection on peripheral neuropathy because
      these studies enrolled small number of patients and lacked controlled design. The
      investigators design a randomized, double-blind, controlled trail to assess the effect after
      ultrasound-guided perineural injection with 5% dextrose in patients with CTS.
    

Detailed description: 
      After obtaining written informed consent, patients of clinically diagnosed with CTS were
      randomized into intervention and control group. Participants in intervention group received
      one-session ultrasound-guided perineural injection with 5% dextrose and control group
      received one-session ultrasound-guided perineural injection with normal saline. No additional
      treatment after injection through the study period. The primary outcome is visual analog
      scale (VAS) and secondary outcomes include Boston Carpal Tunnel Syndrome Questionnaire
      (BCTQ), cross-sectional area (CSA) of the median nerve, sensory nerve conduction velocity of
      the median nerve, and finger pinch strength. The evaluation was performed pretreatment as
      well as on the 2nd, 4th, 8th, 12th, 16th and 24th week after the treatment.
    

Intervention name(s): Ultrasound-guided perineural injection with 5% dextrose; Ultrasound-guided perineural injection with normal saline; Normal Saline; 5% Dextrose
Intervention type(s): Procedure; Procedure; Drug; Drug
Intervention description(s): Ultrasound-guided perineural injection with 5% dextrose (3cc) between proximal carpal tunnel and surrounding median nerve with hydrodissection.; Ultrasound-guided perineural injection with normal saline (3cc) between proximal carpal tunnel and surrounding median nerve with hydrodissection.; Normal saline is safe for perineural injection.; 5% Dextrose could decrease the release of CGRP and substance P to reduce the nerve inflamation.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Carpal Tunnel Syndrome; Perineural injection; Dextrose
Drug-drug Interactions Between DZD9008 and Itraconazole/Carbamazepine
Condition: Healthy Subjects
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a Phase 1, single-center, nonrandomized, open-label, 2-part, fixed-sequence,
      drug-drug interaction (DDI) study to assess the effect of multiple doses of itraconazole, a
      CYP3A4 enzyme inhibitor, on the single dose PK of DZD9008 in healthy adult subjects (Part A)
      and to assess the effect of multiple doses of carbamazepine, a CYP3A4 inducer, on the single
      dose PK of DZD9008 in healthy adult subjects (Part B).
    


Intervention name(s): DZD9008 and intraconazole; DZD9008 and carbamazepine
Intervention type(s): Drug; Drug
Intervention description(s): All subjects will receive DZD9008 single dose on Day 1, and the second dose of DZD9008 along with itraconazole after the wash-out period.; All subjects will receive DZD9008 single dose on Day 1, and the second dose of DZD9008 along with carbamazepine after the wash-out period.
Intervention MeSH terms: Carbamazepine
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Other
A Study to Compare Pharmacokinetics and Pharmacodynamics of Insulin Aspart to NovoRapid® Penfill® in Healthy Subjects
Condition: Clamp Study
Study type: Interventional

Summary: 
      Pharmacokinetics and pharmacodynamics study of 2 formulations of insulin aspart (Insulin
      Aspart GEROPHARM vers. NovoRapid® Penfill® Novo Nordisk)
    

Detailed description: 
      A randomized double blinded two-way crossover single-dose pharmacokinetics and
      pharmacodynamics study of Insulin Aspart (LLC "GEROPHARM", Russia) versus NovoRapid® Penfill®
      (Novo Nordisk) in normal healthy subjects using the euglycemic clamp technique
    

Intervention name(s): Insulin Aspart; NovoRapid® Penfill®
Intervention type(s): Drug; Drug
Intervention description(s): insulin aspart in doses 0.3 IU/kg; insulin aspart in doses 0.3 IU/kg
Other intervention name(s): insulin aspart
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Insulin Aspart; Insulin, Long-Acting; Insulin degludec, insulin aspart drug combination
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: two-way crossover
Masking: Single (Outcomes Assessor)
Primary purpose: Basic Science
Keywords: Pharmacokinetics; Pharmacodynamics; Insulin Aspart
Child Asthma : What Parents Attitude During an Asthma Attack at Home Before Consulting the Pediatric Emergencies
Condition: Asthma in Children; Asthma Attack; Therapeutic Adherence
MeSH terms: Asthma; Emergencies
Study type: Observational

Summary: 
      prospective multicenter observational study. Parents whose children meet the inclusion
      criteria complete a questionnaire assessing the child's follow-up, the management of the
      current asthma attack, and the treatment provided at home.

      The main objective is to calculate the prevalence of placement of short-acting
      bronchodilators. The secondary objectives are to describe the factors associated with their
      implementation.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        children between 2 and 15 years old in Quimper or Brest emergency department for asthma
        attacks whose parents agree to fill in a questionnaire about their pre-hospital attitude.
Extension Study of Proellex in Women Who Have Previously Completed Study ZPU 003
Condition: Uterine Fibroids
MeSH terms: Leiomyoma; Myofibroma
Study type: Interventional
Phase: Phase 2

Summary: 
      ZPU-003 EXT is a 2-year extension study of ZPU-003 (NCT00882258) to determine the continued
      safety and efficacy of Proellex in women who have previously completed the double-blind
      portion of the study.
    

Detailed description: 
      ZPU-003 EXT is a 2-year extension study of ZPU-003 (NCT00882258). The purpose of the study is
      to determine the continued safety and efficacy of Proellex in women who have previously
      completed the double-blind portion of the study. The desired primary efficacy outcome will be
      a changes in vaginal bleeding from baseline to 14 months and 17 months on study drug. The
      total duration of the study is up to 24 months including transition times, off drug
      intervals, and follow-up visits). It is expected that over a 16 week on drug interval menses
      will subside and return after a 4-8 week off drug interval (ODI).
    

Intervention name(s): Proellex®
Intervention type(s): Drug
Intervention description(s): 25 mg daily (two 12.5 mg capsules)
Other intervention name(s): CDB-4124; telapristone acetate
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Uterine fibroids