bioihbjkbjnl/mcl2 huggingface dataset:
Single Dose, Single Administration Study of Technosphere Inhalation Powder in Diabetic Subjects With Mild or Moderate Kidney Disease Compared to Diabetic Subjects With Normal Kidney Function
Condition: Mild Nephropathy; Moderate Nephropathy; Diabetes Mellitus
MeSH terms: Kidney Diseases
Study type: Interventional
Phase: Phase 1

Summary: 
      24 diabetics with mild & moderate renal disease and 12 diabetics without renal disease. One
      screening, one dosing & one follow-up visit with TechnosphereÂ® Inhalation Powder given at
      Visit 2 via MedToneÂ® Inhaler and PK testing at 26 designated time points
    

Detailed description: 
      This Phase 1, single-dose trial is being conducted to determine if nephropathy affects the
      way the kidneys eliminate the byproducts of TechnosphereÂ® Inhalation Powder as compared to
      kidneys free of disease. This trial will test the safety, tolerability and pharmacokinetics
      of the study medication. The trial consists of a screening, dosing and a follow-up visit.
      Single dose administration of TechnosphereÂ® Inhalation Powder occurs at the dosing visit.
      (V2) with serum and urine PK testing .
    

Intervention name(s): Technosphere Inhalation Powder
Intervention type(s): Drug
Intervention description(s): Technosphere Inhalation Powder
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Nephropathy; Kidney Disease; Diabetic; Renal; Diabetics
Pharmacokinetics of a Single 14C-labeled Dose of Risedronate or Alendronate Followed by Once-a-week Unlabeled Oral Dose
Condition: Osteopenia; Osteoporosis
MeSH terms: Osteoporosis; Bone Diseases, Metabolic
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective of this study is to compare the urinary excretion of 14C-labeled
      risedronate and alendronate over 28 days.
    


Intervention name(s): risedronate; alendronate
Intervention type(s): Drug; Drug
Intervention description(s): 0.23 mg 14C-labeled risedronate, followed 7 days later with oral 35 mg risedronate once a week for 52 weeks followed by another 14C-labeled risedronate followed weekly by 35 mg risedronate for 3 weeks; 0.45 mg 14C-labeled alendronate, followed 7 days later with oral 705 mg alendronate once a week for 52 weeks followed by another 14C-labeled alendronate followed weekly by 70 mg alendronate for 3 weeks
Intervention MeSH terms: Alendronate; Risedronic Acid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
The Natural Course of Trichophyton Tonsurans Carriage and Infection: A Molecular and Biochemical Evaluation
Condition: Tinea Capitis
MeSH terms: Tinea Capitis
Study type: Observational

Summary: 
      To explore carrier and infection status of T.tonsurans tinea capitis and characterize the
      host-pathogen interaction as it relates to the disease presentation. The general hypothesis
      for this study is as follows: the type of genotypic and phenotypic variant to which a child
      is exposed accounts for the presentation status observed in Trichophyton tonsurans
      infection.The global outcome of this investigation is to reveal potential new drug targets
      designed to improve treatment outcomes in these children.
    

Detailed description: 
      Tinea capitis is an overwhelmingly prevalent disease of childhood estimated to be present in
      approximately 1 in 20 children at any point in time with an equal number of children serving
      as carriers of the fungal pathogen. Despite the widespread nature of the disease, the natural
      course of the infection remains incompletely described. The study will be driven by the
      following hypothesis: the type of genotypic and phenotypic variant to which a child is
      exposed accounts for the presentation status observed in Trichophyton tonsurans infection.

      A fungal scalp culture will be acquired from all participants using a brush culture
      technique. Samples will be collected once a month over a two year time period.
    

Intervention name(s): Scalp Brushing
Intervention type(s): Procedure
Intervention description(s): sterile, soft-head toothbrush massaged on scalp
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        preschool aged children
      
Biospecimen description: 
      fungal scalp cultures
    
Keywords: Tinea Capitis
The Effect of Neuroscience Pain Education on Quality of Life in Patients With Chronic Low Back Pain
Condition: Chronic Low Back Pain; Quality of Life; Pain
MeSH terms: Back Pain; Low Back Pain
Study type: Interventional

Summary: 
      Manual therapy are among the therapeutic approaches frequently used in chronic low back pain
      (CLBP). Although most clinicians conduct patient education according biomedical model of
      pain, a relatively new approach which is referred to as neuroscience pain education (NPE) is
      promising in patients with CLBP. Therefore the aim of this study was to investigate whether
      NPE in patients with CLBP who treated via manual therapy technique will produce different
      outcomes in terms of pain severity and QoL compared to traditional patient education.
    


Intervention name(s): Neuroscience pain education; Traditional patient education; Manual therapy
Intervention type(s): Other; Other; Other
Intervention description(s): In Neuroscience pain education (NPE) sessions, patients were informed about the pain experience and the neurophysiological process about pain. NPE was performed by the method proposed by Louw et al (12). NPE was administered 4 sessions per week for four weeks. Trainings were conducted in the form of face-to-face interview and 45-50 minutes of one-to-one sessions.; In traditional patient education (TPE) sessions were aimed to explain to patients a proposed treatment or efficacy of a certain manual therapy technique or approach, have focused heavily on biomechanical and anatomical models. These models would imply that injury, disease, and muscle guarding may lead to altered movement patterns, asymmetrical loading, and resultant pain and dysfunction. TPE was administered 4 sessions per week for four weeks. Trainings were conducted in the form of face-to-face interview and 45-50 minutes of one-to-one sessions.; Manual therapy (MT) was individualized according to each patient's response to treatment. In this method, the physiotherapist identifies and performs techniques suitable for the patient's symptoms. If the selected techniques do not have a direct positive effect on the patient's symptoms, they are replaced with other techniques.MT were performed in a total of 8 sessions, held twice a week for 4 weeks. Treatment sessions lasted an average of 40-45 minute.The entire treatment program was carried out by the same physiotherapist who is trained and experienced in this area.
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Manual Therapy; Neuroscience pain education; Quality of life; Chronic low back pain
INfrapatellar Versus SUprapatellar Reamed Intramedullary Nailing for Fractures of the Tibia
Condition: Tibial Fractures; Anterior Knee Pain Syndrome
MeSH terms: Patellofemoral Pain Syndrome; Fractures, Bone; Tibial Fractures
Study type: Interventional

Summary: 
      This study will investigate the incidence and severity of anterior knee pain comparing two
      different approaches to tibial nail fixation; Infrapatellar versus percutaneous semi-extended
      suprapatellar incisions. Half the patients will be randomized to the gold standard
      infrapatellar approach with the other half being randomized to treatment with the
      percutaneous semi-extended suprapatellar approach.
    

Detailed description: 
      There are a number of ways to approach the tibial canal when using an intramedullary nail for
      fracture fixation.

      The gold standard is the infrapatellar approach (below the knee cap). This approach has the
      patient positioned with the knee flexed at 90 degrees or greater on the operating table.
      However, there are challenges with this approach, including imaging, placement of
      supplemental fixation, conversion to open reduction when necessary and malunion with apex
      anterior angulation for proximal tibial fractures. The positioning of the patient causes
      tension on the structures and soft tissues around the knee which can hinder the placement of
      the nail and can cause damage to the soft tissues that can result in significant long-term
      anterior knee pain for many patients.

      The semi-extended suprapatellar approach has the patient positioned in approximately 15-20
      degrees of flexion, putting less tension on the structures and soft tissues about the knee
      and enables the surgeon to insert the nail in an optimal position with relative ease.
    

Intervention name(s): Infrapatellar Approach; Suprapatellar Approach
Intervention type(s): Procedure; Procedure
Intervention description(s): Infrapatellar approach using the surgeon's incision of choice (i.e. patellar tendon split, tendon retraction medial, tendon retraction lateral); Semi-extended suprapatellar approach using quadriceps split combined with purpose designed percutaneous instrumentation
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
The Effect of Upper Transabdominal Plain Block on Diaphragm Thickness
Condition: Anesthesia, General
Study type: Observational [Patient Registry]

Summary: 
      In the study, patients of both sexes between the ages of 18 and 60 who will undergo
      laparoscopic cholecystectomy will be examined. In this patient group, the change in the
      inspiratory and expiratory diaphragmatic thickness before and after laparoscopic
      cholecystectomy operation in the upper transabdominal block group will be examined.
    

Detailed description: 
      The use of ultrasonography (USG) in operating rooms is increasing day by day. Diaphragm
      thickness can be evaluated by ultrasonography and is used as a bedside method studies have
      proven that the evaluation of diaphragmatic thickness contributes to the observation of
      diaphragmatic function and the evaluation of respiratory workload. Measurement of
      diaphragmatic thickness is a method used in operating rooms and intensive care units to make
      the decision to wean from mechanical ventilation and extubation. Laparoscopic gallbladder
      operations are a very common operation in the adult age group in the operating room. In these
      cases who were intubated and extubated at the end of the operation, regression in respiratory
      function is observed, especially due to right upper quadrant pain appropriate to the location
      of the liver. For this reason, the respiratory functions of patients who will have
      gallbladder surgery will be routinely evaluated before and after gallbladder surgery in our
      clinic with the help of USG and routinely apply analgesic methods, including peripheral nerve
      blocks, to patients with pain.

      In this study, it will be planned to observe the effect of upper transabdominal area block,
      which is routinely performed post-operatively in laparoscopic gallbladder operations, on
      diaphragmatic thickness and therefore on respiratory capacity, and observationally evaluating
      diaphragmatic thickness measurements by USG, which is routinely performed post-operatively
      and the measurement records are noted.
    

Intervention name(s): Ultrasound measurement
Intervention type(s): Diagnostic Test
Intervention description(s): In the patient group who will undergo elective laparoscopic cholecystectomy, the diaphragmatic thickness values measured and recorded routinely at the pre-operative, post-extubation and post-operative 30th minute, at the end of inspiration and expiration, and the inspiratory amplitude in m-mode in the ultrasound measured from the right anterior axillary line subcostal area were observed as observational data. will be saved in our file.
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        With the calculated sample size values, we will need to include at least 68 patients in our
        study at 0.5 sensitivity and 0.95 power.
      
Keywords: Laparoscopic Cholecystectomy Operation; Diaphragm Thickness; Upper Transabdominal Plain Block
The Star Excursion Balance Test: Analysis of Children With Cerebral Palsy
Condition: Search MeSH
Study type: Interventional

Summary: 
      PURPOSE: The investigators estimated the reliability, standard error of measurement (SEM),
      and minimum detectable change (MDC) of the star excursion balance test (SEBT) in children
      with cerebral palsy (CP).

      METHODS: Eight children with CP (four boys and four girls, sixteen legs) participated in this
      study. Each child carried out the SEBT and was assessed by two examiners. To determine
      intra-rater reliability, the investigators calculated the intra-class correlation coefficient
      (ICC) model (3,3). The investigators also calculated the ICC model (2,3) to determine the
      inter-rater reliability.
    


Intervention name(s): The star excursion balance test
Intervention type(s): Other
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
APrevent Vocal Implant System (VOIS) for Adjustable Treatment of Unilateral Vocal Fold Paralysis (UVFP)
Condition: Paralysis, Unilateral, Vocal Cord
MeSH terms: Vocal Cord Paralysis; Paralysis
Study type: Interventional

Summary: 
      The objective of this study is to evaluate pre- and intraoperative voice quality, the degree
      of vocal fold closure and the Maximum Phonation Time (MPT), first determined after temporary
      APrevent® VOIS implantation and then after permanent existing product implantation.
    


Intervention name(s): thyroplasty implant
Intervention type(s): Device
Intervention description(s): Short-term implantation of thyroplasty implant, VOIS, and evaluation of voice quality and glottal closure. After evaluation, remove VOIS and perform medialization of vocal folds using conventional thyroplasty.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Device Feasibility
Keywords: unilateral vocal fold paralysis; type I thyroplasty
Evaluation of Drug Interaction Between HS-10234 and Emtriccitabine
Condition: Healthy Subjects
Study type: Interventional
Phase: Phase 1

Summary: 
      The study is being conducted to evaluate drug interaction between HS-10234 and Emtricitabine
      after multiple dose in healthy subjects.
    

Detailed description: 
      The study includes two parts. Part 1 is to evaluate the impact of Emtricitabine on HS-10234.
      Part 2 is to evaluate the impact of HS-10234 on Emtricitabine.
    

Intervention name(s): HS-10234; Emtricitabine
Intervention type(s): Drug; Drug
Intervention description(s): HS-10234; Emtricitabine
Intervention MeSH terms: Emtricitabine
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: HIV
Effectiveness of US-Guided PCNL Different Positions in Renal Stones Treatment
Condition: Percutaneous Nephrolithotomy; Renal Stones; Ultrasound Therapy; Complications
MeSH terms: Kidney Calculi; Nephrolithiasis
Study type: Observational

Summary: 
      The aim of this study is to compare the effectiveness of Ultrasound-Guided Percutaneous
      nephrolithotomyin different positions supine, prone positions and flank suspend supine
      position in renal stones treatment.
    

Detailed description: 
      Percutaneous nephrolithotomy (PCNL) has become the choice of modality for the treatment of
      large and complicated renal calculi. Initially, percutaneous access to the kidney was only
      performed in the prone position, as described sixty years ago.
    

Intervention name(s): Flank suspended supine position percutaneous nephrolithotomy; Supine percutaneous nephrolithotomy group; Prone percutaneous nephrolithotomy group
Intervention type(s): Procedure; Procedure; Procedure
Intervention description(s): The patients will be placed in the supine position with the shoulder and the buttock will be raised by a 3-l bag of water suspending the flank of the affected side. The body contour will be aligned to the edge of the table. The operating table will be adjusted to the jack knife position, with the tip of the lower part of the table will be slightly lowered. The leg of the affected side of the patent will be straightened dorsally flexed and slightly inner rotated, with the knee of the other side will be flexed. The patients will be then immobilized at the chest and the pelvis with two adherent tapes which crossed each other at the abdomen to form a 'V' shape.; The patient will remain in the supine position, with the side of interest at the edge of the table, with a small cushion placed under the flank to elevate it 15-20°.; Prone percutaneous nephrolithotomy. The prone position (PRON) technique followed these classic steps: patients will be placed in a lithotomy position and a ureteral catheter will be inserted through a rigid cystoscope to perform a retrograde pyelogram. The ureteral catheter will be fixed to a Foley catheter, and then the patient will be repositioned to the prone position with pads under their shoulders.
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        123 patients who underwent Percutaneous nephrolithotomy at the period from 2018 to 2022 and
        were diagnosed with consecutive, adult obese patients (age >18-70 years) with renal stones
        diameter ≥2 cm
Effects of Hydrogen Gas Inhalation on Adults of Various Ages
Condition: Alzheimer Disease
MeSH terms: Alzheimer Disease
Study type: Interventional

Summary: 
      Herein, investigated the effects of 4 weeks of H2 gas inhalation on community-dwelling adults
      of various ages.
    

Detailed description: 
      Molecular hydrogen (H2) is a versatile therapeutic agent. H2 gas inhalation is reportedly
      safe and has a positive impact on a range of illnesses, including Alzheimer's disease (AD).
      Herein, investigated the effects of 4 weeks of H2 gas inhalation on community-dwelling adults
      of various ages. Fifty-four participants including those dropped out (5%) were screened and
      enrolled. The selected participants were treated as a single group without randomization.
      Evaluated the association between total and differential white blood cell (WBC) counts and AD
      risk at individual levels after 4 weeks of H2 gas inhalation treatment. Furthermore,
      evaluation of dementia-related biomarkers such as beta-site APP cleaving enzyme 1 (BACE-1),
      amyloid beta (Aβ), brain-derived neurotrophic factor (BDNF), vascular endothelial growth
      factor A (VEGF-A), T-tau, monocyte chemotactic protein-1 (MCP-1), and inflammatory cytokines
      (interleukin-6).
    

Intervention name(s): H2 gas inhalation
Intervention type(s): Other
Intervention description(s): H2 gas inhalation treatment for 4 weeks in on community dwelling adults of various ages
Intervention model: Single Group Assignment
Intervention model description: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Proteome Remodelling
Condition: Skeletal Muscle Physiology
Study type: Interventional

Summary: 
      The purpose of the project is to investigate the proteome signature dynamics and remodelling
      in human skeletal muscle induced by exercise training
    


Intervention name(s): Endurance training; Resistance training; Sprint training
Intervention type(s): Other; Other; Other
Intervention description(s): Subjects perform a period of endurance training; Subjects perform a period of resistance training; Subjects perform a period of sprint training
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Evaluating Factors That Impact Loss to Follow-up Among Postpartum HIV-infected Women in Mississippi
Condition: HIV
Study type: Observational

Summary: 
      Women with HIV infection in Mississippi who are pregnant or who have had their baby in the
      past year can agree to fill out a questionnaire about what helps or hurts return to care for
      HIV infection after having a baby. The combined results should show the most common things
      that keep women from getting care for HIV infection after having a baby. This will help
      design another study in order to help more women get into care for HIV infection after having
      a baby.
    

Detailed description: 
      Following recruitment and completion of informed consent, a participant will be given a
      questionnaire to look at factors that help or hinder access to HIV care after delivery. After
      finishing the initial questionnaire the participant will get a Wal-Mart gift card for $15.
      The participant may then be asked to complete a longer interview for which she would receive
      an additional gift card for $25. The combined results will be used to design an
      interventional study to improve entry into HIV care after delivery.
    

Observational model: Case-Only
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Women in Mississippi with HIV infection who have been pregnant and received perinatal HIV
        care at University of Mississippi Medical Center are eligible to participate in a
        questionnaire study on the factors that affect entry into HIV care after delivery
      
Keywords: HIV; postpartum; postpartum entry into HIV care
Evaluation of the Effectiveness and Safety of the Ulthera® DeepSEE® System for Treating Skin Laxity in the Lower Face and Submentum
Condition: Improvement in Skin Laxity of the Lower Face and Submentum
MeSH terms: Cutis Laxa
Study type: Interventional

Summary: 
      1. Demonstrate superiority of treatment with the Ulthera DeepSEE System compared to
           untreated control for the improvement of skin laxity of the lower face and submental
           area.

        2. Demonstrate the safety of treatment with the Ulthera DeepSEE System for the improvement
           of skin laxity of the lower face and submental area.
    

Detailed description: 
      Subjects in the study received a single treatment with Ulthera DeepSEE system on the midface,
      lower face, submental (under the chin) and upper neck area using 3 DeepSEE (DS) transducers
      (DS 10-1.5, DS 7-3.0, DS 7-4.5) at either Day 1 or Day 90. Subjects treated at Day 1 were
      followed for 180 days after treatment and subjects treated at Day 90 were followed for 90
      days after treatment.
    

Intervention name(s): Ultherapy treatment; Untreated-control / delayed-treatment
Intervention type(s): Device; Device
Intervention description(s): Focused ultrasound energy delivered below the surface of the skin; Untreated-control, followed by Ultherapy treatment (focused ultrasound energy delivered below the surface of the skin)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment