bioihbjkbjnl/mcl2 huggingface dataset:
Project Nightlight: Efficacy and System Acceptance of Dinner/Night vs. 24hr Closed Loop Control
Condition: Diabetes Mellitus, Type 1
MeSH terms: Diabetes Mellitus, Type 1
Study type: Interventional

Summary: 
      The purpose of this study is to use an investigational type of technology called Closed-Loop
      Control (CLC) Medical Platform System to help control blood sugar in people with type 1
      diabetes mellitus in a home setting.
    

Detailed description: 
      The CLC is an "artificial pancreas" (AP) application that uses advanced closed loop control
      algorithms to automatically manage blood glucose levels for people with Type 1 Diabetes. The
      system modulates insulin to keep blood glucose in a targeted range. The CLC will be deployed
      with different functionalities at different stages of the trial, resulting in variation in
      what the subject will be responsible for and what the system will drive.These functionalities
      occur in a randomized cross-over design, each occurring for 8 weeks. These modalities are:

        1. SAP=sensor-augmented pump only

        2. USS+SAP (d)= Evening and Overnight Closed-Loop Control=SAP during day and CLC starting
           at dinner and continuing overnight

        3. USS+CLC (d)= 24/7 Closed-Loop Control=24-hour Day and Night Closed Loop Control
    

Intervention name(s): CLC
Intervention type(s): Device
Intervention description(s): The CLC will be deployed with different functionalities at different stages of the trial, resulting in variation in what the subject will be responsible for and what the system will drive.
Other intervention name(s): Closed Loop Control
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Closed-Loop Control (CLC); Sensor-Augmented Therapy (SAP); USS Virginia; Continuous Glucose Monitor (CGM); Insulin Pump; Artificial Pancreas (AP)
Group Training and Quality of Life and Reduction of Pain in Rheumatoid Arthritis Patients
Condition: Training Leaflet; Training Workshop
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Interventional

Summary: 
      Abstract

      Background:

      It is documented that some patient education interventions, preferably with a behavioral
      component included, may improve pain, disability and moods Purpose of the study: the purpose
      of this study was to improve the quality of life and reduce pain in rheumatoid arthritis
      patients.

      Methods:

      Patients were allocated to a patient training intervention group and patient without training
      intervention group. Both groups received routine treatments while the patient training
      intervention group, in addition to the routine treatments received training booklets and
      participated in the training workshop. All the extracted data from the written questionnaire
      were collected and analyzed using SPSS software.
    

Detailed description: 
      Results:

      The improvement in the signs of recovery for physical and mood symptoms in the patient
      training intervention group were seen (p < 0.05). The score of quality of life had
      significantly improved in the two groups (Mean difference was 9.31±3.03 and P<0.003). This
      improvement was significantly higher in the patient training intervention group (P=0.008).
      After adjustment for education level, the score of quality of life in patient training
      intervention group had a higher improvement, but the difference between the two groups was
      not significant (P = 0.1).

      Conclusions:

      This study showed the important role of training and the patients' educational level on
      better treatments. The appropriate training in the patient could create a change in the
      treatment process and has a better effect on quality of life.
    

Intervention name(s): training leaflet and oral training
Intervention type(s): Behavioral
Intervention description(s): The intervention consisted of training leaflet and oral training. All of the patients were new cases and were divided into 2 groups. All patients were treated with routine medication, no addition medication for two groups were done, the case group attended the workshops and were trained In addition to medical therapy, continuing education and training workshop. The result of the effect of workshop was also filling out a questionnaire before and after training. Finally, two groups with statistical analysis were compared.
Other intervention name(s): education; training workshop
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Patient training; Rheumatoid arthritis; Quality of life
Efficacy of Diathermy on Healing Power of Cesarean Section Scar
Condition: Healing Surgical Wounds
MeSH terms: Surgical Wound
Study type: Interventional

Summary: 
      To compare the effects of electro-surgery on healing power as a primary outcome (from skin to
      the peritoneum. And volume of blood loss, incision time and postoperative surgical wound pain
      as secondary outcomes.
    

Detailed description: 
      This is a prospective study is carried out at Ain Shams University Maternity Hospital,
      Obstetrics and Gynecology Department, Faculty of medicine in women undergoing CS through
      pfannentiel incisions.

      All women will receive intravenous antibiotic prophylaxis according to the Ain Shams
      guideline, 1 g of cefazolin given at the time of incision.

      Diathermy incisions will be carried out using monopolar blade pen electrode, set on cutting
      mode and delivering a 35 continuous current. Electrosurgical cutting will be performed
      without pressure or mechanical displacement.

      'Bleeders' will be controlled by using diathermy, on coagulating mode, and will be applied to
      a hemostat on the vessels.

      Incisions made by the scalpel will be done by the traditional method, with proper hemostasis
      by application of pressure to skin blood vessels and by ligating the subcutaneous bleeders.

      After the operation and during the postoperative period, paracetamol (10mg/mL) 50-mL vial
      will be administered by i.v. infusion for analgesia on demand according to the patient's need
      with a 500-mg dose. And the wound will be sutured subcuticle by a prolene 3.0 sutures.
    

Intervention name(s): diathermy; scalpel
Intervention type(s): Device; Device
Intervention description(s): In women undergoing C.S, is healing power after diathermy equally to healing power after scalpel?; Incisions made by the scalpel will be done by the traditional method, with proper hemostasis by application of pressure to skin blood vessels and by ligating the subcutaneous bleeders.
Other intervention name(s): electro-cautrey
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: The 180 patients who will be included in our study will be randomized through computer generated system in to 2 groups. Group D (diathermy) and group S (scalpel). Each group will include 90 patients.
Allocation and concealment will be done by sequentially sealed opaque envelopes. 180 envelopes will be numbered serially from 1 to 180, 90 envelopes will contain the letter D and the other 90 will contain the letter S.
In each envelope, the corresponding letter which donates the allocated group will be put according to the randomization table and them all envelopes will be closed and put in one box. When the first patient arrives, the first envelope will be opened and the patient will be allocated according to the letter inside, whom will be allocated by a person not involved in the study.
Masking: Double (Care Provider, Investigator)
Primary purpose: Other
Phase 1 TAK-915 Single-Dose Positron Emission Tomography (PET) Occupancy Study
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      This phase 1 study will be conducted to examine the degree and duration of brain PDE2A enzyme
      occupancy /target engagement as a function of TAK-915 plasma concentration in order to guide
      dosing and schedule for future clinical studies in schizophrenia with TAK-915.
    

Detailed description: 
      The drug being tested in this study is called TAK-915. TAK-915 is being tested to examine the
      degree and duration of brain phosphodiesterase 2A (PDE2A) enzyme occupancy/target engagement
      as a function of TAK-915 plasma concentration in order to guide dosing and schedule for
      future clinical studies in schizophrenia. This study will look at PDE2A brain enzyme
      occupancy in the putamen as a function of TAK-915 plasma concentration, as assessed using the
      positron emission tomography (PET) ligand [18F]MNI-794 after single dosing of TAK-915.

      The study will enroll approximately 16 patients in total and within that total, allow up to 5
      dose levels and up to 6 subjects per dose level. All participants will receive a single dose
      of TAK-915 on Day 1. The initial TAK-915 dose level to be studied is 100 mg. Subsequent dose
      levels may be lower or higher and will be determined through dose level review meetings
      (DLRMs) following approximately every 2 participants and based on prior occupancy, duration
      of occupancy, safety, tolerability, and available pharmacokinetic (PK) data.

      This single center trial will be conducted in the United States. The overall time to
      participate in this study is up to 55 days. Participants will make multiple visits to the
      clinic, and will be contacted by telephone 22 days after last dose of study drug for a
      follow-up assessment.
    

Intervention name(s): TAK-915
Intervention type(s): Drug
Intervention description(s): TAK-915 oral suspension
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Drug therapy
PEEK and Allograft Spacers Evaluation in Spinal Fusion Surgeries
Condition: Degenerative Disc Disease
MeSH terms: Intervertebral Disc Degeneration
Study type: Observational

Summary: 
      Purpose The primary purpose of this study is to prospectively compare clinical and
      radiographic clinical outcomes in patients undergoing cervical or lumbar interbody fusions
      and randomized to receive either polyetheretherketone (PEEK) or cortical allografts.
    

Detailed description: 
      Following surgery study subjects will be evaluated at the following intervals: 3 (+/- 2
      weeks), 6 (+/- 1 month), 12 (+/- 2 months), 24 (+/- 2 months) months.
    

Intervention name(s): Posterior/Transforaminal Lumbar Interbody Fusion (P/TLIF), Anterior Cervical Discectomy and Fusion (ACDF)
Intervention type(s): Procedure
Intervention description(s): Lumbar or cervical fusion
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Boulder Neurosurgical Associates patients
      
Keywords: Degenerative disc disease; spinal stenosis; herniated disc
A Study to Test the Safety, and Tolerability of Padsevonil in Healthy Male Japanese Study Participants
Condition: Healthy Japanese Participants
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of the study is to investigate the pharmacokinetics (PK) of padesevonil in
      CYP2C19 genotyped healthy male Japanese study participants.
    


Intervention name(s): Padsevonil
Intervention type(s): Drug
Intervention description(s): Padsevonil will be administered in predefined dosages.
Intervention MeSH terms: Padsevonil
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Padsevonil; CYP2C19; Healthy Japanese Participants; Pharmacokinetics
The Effects of Caffeine on Human Spinal Motoneurons
Condition: Healthy
Study type: Interventional

Summary: 
      This study evaluates the effects of orally ingested, commercially available, coffee (3 mg/kg
      of caffeine) on the excitability of human spinal motoneurons of the lower leg.
    

Detailed description: 
      Recently, it has been shown that human spinal motoneurons do not simply act as a binary
      control system. Instead, they are regulated by intrinsic properties that can elicit lingering
      effects on the descending motoneuron. Caffeine, one of the world's most popular
      over-the-counter supplements, can potentially augment these characteristics of motoneurons.
      Using decomposition software and non-invasive, high-density surface electromyography, it is
      possible to extract the characteristics of these motoneurons. This project will utilize a
      double-blind, inactive-placebo controlled, crossover design study to examine and quantify the
      effects of caffeine on motoneuron excitability.
    

Intervention name(s): Coffee; Decaffeinated coffee
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Starbucks brand "Via" instant coffee. (Caffeine Content: 3 mg / kg); Starbucks brand "Via" instant decaffeinated coffee. (Caffeine Content: 15 - 25 mg)
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: Motor Neuron; Excitability; Caffeine
Cell Therapy for CD7 Positive T-cell Acute Lymphoblastic Leukemia and Lymphoblastic Lymphoma Using CD7-Specific CAR-T Cells
Condition: T-cell Acute Lymphoblastic Leukemia/Lymphoma
MeSH terms: Lymphoma; Leukemia; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Leukemia, Lymphoid; Precursor T-Cell Lymphoblastic Leukemia-Lymphoma
Study type: Interventional
Phase: Phase 1

Summary: 
      This is an open, single-arm, clinical study to evaluate efficacy and safety of anti CD7 CAR-T
      cell in the treatment of relapsed or refractory T-cell acute lymphoblastic leukemia (T-ALL)
      and lymphoblastic lymphoma (TLBL).
    

Detailed description: 
      The CARs consist of an anti-CD7 single-chain variable fragment（scFv）, a portion of the human
      CD137（4-1BB） molecule, and the intracellular component of the human CD3ζ molecule. Prior to
      CAR-T cell infusion, the patients will be subjected to preconditioning treatment. After CAR-T
      cell infusion, the patients will be evaluated for adverse reactions and efficacy.

      The Main research objectives:

      To evaluate the safety and efficacy of CD7 CAR-T cells in patients with relapsed or
      refractory T-ALL/LBL

      The Secondary research objectives:

      To investigate the cytokinetic characteristics of CD7 CAR-T cells in patients with relapsed
      or refractory T-ALL/LBL
    

Intervention name(s): CD7 CAR-T
Intervention type(s): Biological
Intervention description(s): Patients will be treated with CD7 CAR-T cells
Biological: CD7 CAR-T; Drug: Cyclophosphamide,Fludarabine; Procedure: Leukapheresis;
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: T-ALL，T-LBL , CD7，CAR-T
S-1 Plus Nedaplatin With Concurrent Radiotherapy for Advanced Esophageal Cancer
Condition: Esophageal Cancer
MeSH terms: Esophageal Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      Patients with advanced esophageal cancer will receive thoracic radiation therapy 60Gy over 30
      fractions,and concurrent with s-1 and nedaplatin.
    

Detailed description: 
      Purpose: To determine the maximum tolerated dose (MTD) and recommended dose (RD) of S-1 in
      combination with nedaplatin and thoracic radiotherapy in patients with advanced esophageal
      Cancer.

      Methods: Thoracic radiation therapy was administered in 2Gy fractions five times weekly to a
      total dose of 60 Gy.Concurrently, nedaplatin was given at a fixed dose of 75 mg/m2 on Days 1,
      and s-1 was given on Days 1-14,repeated every 4 weeks for four cycles. The dose of s-1 was
      initially 60 mg/m2/day and gradually increased to determine the MTD and RD of this regimen.
    

Intervention name(s): S-1, Nedaplatin
Intervention type(s): Drug
Intervention description(s): nedaplatin was given at a fixed dose of 75 mg/m2 on Days 1, and s-1 on Days 1-14, repeated every 4 weeks for four cycles. The dose of s-1 was initially 60 mg/m2/day and gradually increased to determine the MTD and RD of this regimen.
Intervention MeSH terms: Nedaplatin
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: esophageal Cancer; radiation; s-1; nedaplatin
Pain, Discomfort, and Functional Impairments During Maxillary Expansion
Condition: Constriction
MeSH terms: Constriction, Pathologic
Study type: Interventional

Summary: 
      Maxillary expansion is associated with varying degrees of pain and functional impairments.
      The current study aims to compare rapid maxillary expansion using a McNamara-type (bonded)
      appliance and slow maxillary expansion using a removable palatal expansion appliance
      concerning patient-centered outcomes. Those outcomes will include pain and discomfort,
      mastication difficulties, swallowing difficulties, and pressure on the soft tissues.
    

Detailed description: 
      Skeletal maxillary constriction is one of the common orthodontic problems of all ages, which
      could be unilateral or bilateral. If it is neglected and not treated, it may result in later
      orthodontic problems such as skeletal deviation of the lower jaw. The current study aims to
      use two types of expanders to treat skeletal maxillary constriction in adolescents aged
      between 12 and 16 years. The study sample will include 52 patients who will be equally
      divided into two groups: the slow and the rapid maxillary expansion groups. Patients will be
      asked to answer a questionnaire within five assessment times during the expansion procedure.
      The questionnaire will contain four questions: 1) What is the degree of discomfort/pain? 2)
      What is the degree of mastication difficulties? 3) What is the degree of swallowing
      difficulties? 4) What is the degree of any sense of pressure in soft tissue?
    

Intervention name(s): The bonded McNamara-type appliance; The removable palatal expansion appliance
Intervention type(s): Device; Device
Intervention description(s): The patient will be asked to expand twice a day until obtaining an overcorrection of 2-3 mm. Then the expander will be kept in place for three months as a retention period.; The slow maxillary expansion will be applied using a removable palatal expansion appliance with a midline screw. The patient will be asked to expand twice a week until obtaining an overcorrection of 2-3 mm.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Pain; Discomfort; Crossbite; Maxillary expansion
Different Stylet Angles for Orotracheal Intubation Using Glidescope® Video Laryngoscope in Children
Condition: Intubation
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate the feasibility of endotracheal intubation via
      glidescope videolaryngoscope (GVL) using different curve of stylet in 120 children aged
      between 1 and 5 year old.
    

Detailed description: 
      Pediatric patients aged 1-5 year old are randomly assigned to one of two groups; standard
      curve (S) and tip-manipulated curve (T) groups. After routine anesthetic induction,
      endotracheal intubation is performed with GVL. Size of GVL blade is selected according to
      weight; GVL 0: <1.5kg, GVL 1:1.5-3.6kg, GVL 2: 1.8-10kg, GVL 2.5: 10-28kg). Before
      intubation, stylet curve is differently manipulated according to group. The style is curved
      in accordance with the curve of GVL blade in S group, whereas the distal tip of style is
      additionally bended to the left (15-20 degree) in T group.

      Time from visualization of glottis with GVL to approaching of endotracheal tube to glottis,
      and time to completion of intubation are measured. In addition, the easiness of intubation is
      assessed using Visual Analogue Scale (0: extremely easy, 10: extremely difficult) and will be
      compared in both groups.
    

Intervention name(s): Glidescope® with tip manipulated stylet; Glidescope® with standard-curved tip
Intervention type(s): Device; Device
Intervention description(s): The intubating style is curved in accordance with the curve of GVL blade and the distal tip of style is additionally bended to the left (15-20 degree); The style is curved in accordance with the curve of GVL blade
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Other
Multicentric, Transversal, Descriptive, Epidemiological Study on the Management of Asthma in Asthmatic Middle East Adult Population
Condition: Asthma
MeSH terms: Asthma
Study type: Observational

Summary: 
      Descriptive study on the management of asthma in asthmatic Middle East adult population :
      Algeria,Egypt, Irak,Iran, Jordan, Koweit, Lebanon, Qatar,Saudi,Tunisia, UAE
    

Detailed description: 
      Multicentric, transversal, descriptive, epidemiological study, conducted in a random sample
      of general practitioner and medical specialist (Pulmonologist and/or allergologist) in the
      public and the private sector.
    

Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Asthmatic since at least one year before inclusion. Patient's informed consent obtained.
      
Keywords: Asthma control
Prevalence and Complications of Suture in the ED
Condition: Suture, Complication
Study type: Observational

Summary: 
      included patients who had sutured wounds in the ED were asked about complications after
      suture .
    

Detailed description: 
      All patients using the emergency room of EPS Fattouma Bourguiba Monastir are welcomed by a
      resident in the suture room. After an inclusion, patients are cared for in the outpatient
      circuit and the suture will be done in the dedicated box. Before discharging the patient,
      instructions and standardized prescriptions are given to the patient such as standard
      prescriptions for local wound care, removal of stitches and verification of vaccination
      status.

      The data relevant to this study are obtained prospectively from a detailed questionnaire in
      the annex and a telephone call and they are completed retrospectively with the data collected
      in the computerized medical record.

      At the healing period, between 15 days and 45 days after the suture, the investigators called
      the patients back in order to know the evolution of the wound, the adherence to the
      instructions and the prescriptions, the quality of healing and the search for complications
      (infection , loose stitches, hematoma, etc.)
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Included patients presented to the outpatient emergency circuit of the EPS Fattouma
        Bourguiba Monastir having as main reason for consultation an acute suturable wound. The
        patients excluded are those who consulted for wounds requiring surgical treatment, septic
        wounds and patients who did not consent to the protocol.
      
Keywords: suture; complications