bioihbjkbjnl/mcl2 huggingface dataset:
Study to Evaluate the Safety, Tolerance, Pharmacokinetics and Preliminary Efficacy of IBI345
Condition: CLDN18.2 Positive Solid Tumors
Study type: Interventional
Phase: Phase 1

Summary: 
      A phase Ia study to evaluate the safety, tolerance, pharmacokinetics and preliminary efficacy
      of IBI345 in patients with CLDN18.2 positive solid tumors
    


Intervention name(s): IBI345
Intervention type(s): Drug
Intervention description(s): IBI345 CAR-T cell injection by intravenous infusion
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
The Quality of Life and Direct Financial Costs Associated With Home Ventilation of Children: A Prospective Study
Condition: Children Receiving Ventilation at Home for Chronic Illness or Disease
MeSH terms: Chronic Disease
Study type: Observational

Summary: 
      The investigators wish to learn about the quality of life (QOL) of children needing long term
      home ventilation and also that of their regular caregivers. In addition, the investigators
      will monitor the extra health-related expenses these families must meet. Data will be
      collected using two age-specific questionnaires of QOL plus a third one validated for
      assessing chronic health care costs. Questionnaires will be administered at an initial face
      to face meeting, supplemented by two telephone follow-up calls, to monitor medical expenses,
      one and two months later.
    


Observational model: Other
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Children receiving home ventilation for chronic illness or disease
      
Keywords: home ventilation
the Effect of Scapular Dyskinesia on the Scapular Balance Angle & Upper Extremity Sensorimotor Function in Spastic Stroke Patient. The Patients Were Diagnosed With the Lateral Scapular Slide Test, Fugl-Meyer Upper Extremity (FMUE) Scale Scores & Scapular Balance Angle Test (SBA).
Condition: Post Stroke Scapular Dyskinesia
MeSH terms: Stroke; Dyskinesias
Study type: Observational [Patient Registry]

Summary: 
      to investigate the effect of Scapular dyskinesia on the scapular balance angle & upper
      extremity Sensorimotor Function in spastic stroke patient.
    

Detailed description: 
      Background: Post stroke Scapular dyskinesia leads to scapulohumeral pain & dysfunction were
      associated with decreased motor function, somatosensory function, limited range of motion,
      and spasticity.

      Objective: to investigate the effect of Scapular dyskinesia on the scapular balance angle &
      upper extremity Sensorimotor Function in spastic stroke patient.

      Methods: sixty patients from both sexes were participated in this study. All the patients
      were diagnosed as spastic stroke patients. The patients were divided into two equal groups;
      group A (30 patients): with high scapular dyskinesia scores, group B (30 patients): with low
      or no scapular dyskinesia scores. The patients were diagnosed with the Lateral scapular slide
      test using Palpation meter (PALM) device, Fugl-Meyer upper extremity (FMUE) Scale scores &
      scapular balance angle test (SBA).
    

Intervention name(s): Assessment of scapular balance angle and upper extremity sensorimotor function
Intervention type(s): Other
Intervention description(s): The patients were diagnosed with the Lateral scapular slide test using Palpation meter (PALM) device, Fugl-Meyer upper extremity (FMUE) Scale scores & scapular balance angle test (SBA).
Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        Sixty stroke patients were randomly selected from Kasr El-Aini Neurological Department,
        outpatient clinic of Faculty of Physical Therapy, Cairo University, October 6 university
        hospital.
Augmentation of Keratinized Tissue Around Dental Implant With a Xenogeneic Collagen Matrix and the Free Gingival Graft
Condition: Inadequately Attached Gingiva
Study type: Interventional

Summary: 
      The purpose of this study is to compare the clinical effects of combined application of
      combined application of a xenogeneic collagen matrix and the free gingival graft in
      augmentation of keratinized tissue around dental implant by single arm clinical trial,
      compared with historical control group 1:application of a xenogeneic collagen matrix,and
      historical control group 2:application of the free gingival graft.
    

Detailed description: 
      The purpose of this study is to compare the clinical effects of combined application of a
      xenogeneic collagen matrix and the free gingival graft in augmentation of keratinized tissue
      around dental implant by single arm clinical trial, compared with historical control group
      1:application of a xenogeneic collagen matrix,and historical control group 2:application of
      the free gingival graft. This study designed a single arm clinical trial. The included
      patients will all be treated with apical repositioned flap with a xenogeneic collagen matrix
      and the free gingival graft. The width of keratinized mucosa, thickness of keratinized
      mucosa, gingival index, probing depth will be measured before surgery and at 2, 6 months
      postoperatively.
    

Intervention name(s): apically repositioned flap+ xenogeneic collagen matrix +free gingival graft
Intervention type(s): Procedure
Intervention description(s): Harvest a strip free gingival graft from the palate, then place it above apically repositioned flap and fix xenogeneic collagen matrix to the recipient bed
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Hysteroscopic Surgery; Retrospective Cross-sectional Study of Reproductive Outcome
Condition: Hysteroscopic Metroplasty and Myomectomy
Study type: Observational

Summary: 
      study of the effect of hysteroscopic sptoplast and hysteroscopic myomectomy on reproductive
      performance of patients with infertility and /or miscarriages
    

Detailed description: 
      Retrospective study and analysis of the reproductive outcome in patients who underwent
      hysteroscopic surgery for infertility at Jordan university hospital and Al-Noor fertility
      centre in Amman, Jordan in the period September 2016-october 2021. Patients were followed up
      for a minimum of 6 months after surgery. Resection of uterine septum or submucosal fibroids
      were included. Data was obtained from the electronic and paper-based clinical files for
      patients who were operated upon at these hospitals. Patients who missed follow up after the
      operation will be contacted by phone or invite them for a clinic review to know of their
      fertility status and pregnancy outcome.
    

Intervention name(s): Naser Al-Husban
Intervention type(s): Procedure
Intervention description(s): uterine surgery
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        female population with infertility or recurrent miscarriages who have uterine septum or
        fibroids
Propionibacterium Acnes in Shoulder Arthroplasty
Condition: Propionibacterium Acnes
MeSH terms: Acne Vulgaris
Study type: Interventional

Summary: 
      The investigator's plan to determine whether pre-operative skin preparation with hydrogen
      peroxide alters rates of P acnes culture positivity. They hypothesize that pre-operative skin
      preparation with hydrogen peroxide will reduce rates of P acnes culture positivity.
    

Detailed description: 
      Over half of all post-operative infections after shoulder arthroplasty are due to
      Propionibacterium acnes. Even in apparently "aseptic" revisions, nearly all cultures taken at
      the time of revision surgery are positive for P acnes, and thus low-grade infection with this
      bacteria may be a more common cause of failure than previously suspected. Current antibiotic
      prophylaxis methods are ineffective against P acnes. Despite intravenous cefazolin, P acnes
      can be cultured from the glenohumeral joint in 42% of patients undergoing primary total
      shoulder arthroplasty. Despite skin preparation with chlorhexidine, P acnes can be cultured
      from 73% of portal sites in arthroscopy. P acnes is further insensitive to alcohol.
      Dermatologists have long been treating P acnes as it is a primary cause of acne vulgaris. One
      of the most popular and effective treatments for acne vulgaris is topical benzoyl peroxide. A
      prior prospective clinical trial demonstrated that adding topical 5% benzoyl peroxide 48
      hours prior to surgery reduced P acnes culture positivity to 6%. The downside of this
      treatment is that it must be applied by the patient, at home, for 48 hours prior to surgery.
      An additional downside is that benzoyl peroxide is a skin irritant that not all patients
      tolerate.

      In aqueous environments, benzoyl peroxide rapidly decomposes into benzoic acid and hydrogen
      peroxide. Benzoic acid is a skin irritant and hydrogen peroxide is the active ingredient.
      Benzoyl peroxide is used instead of hydrogen peroxide because hydrogen peroxide breaks down
      into water and oxygen when exposed to light. Recently, stabilized forms of hydrogen peroxide
      have been developed and have been demonstrated to be equally effective to benzoyl peroxide in
      the treatment of acne vulgaris. One potential reason for hydrogen peroxide's efficacy against
      P acnes is that it is absorbed into the skin, addressing P acnes residing in sebaceous
      glands. To date, no studies have examined whether the addition of hydrogen peroxide to
      pre-operative skin preparation can reduce intra-operative P acnes culture positivity.
    

Intervention name(s): 3% hydrogen peroxide
Intervention type(s): Other
Intervention description(s): The treatment group will also undergo skin preparation with 3% hydrogen peroxide.
Intervention MeSH terms: Hydrogen Peroxide
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: hydrogen peroxide; Propionibacterium Acnes; shoulder arthroplasty
A Study of Safety and Primary Immunogenicity of 9-valent HPV Recombinant Vaccine
Condition: HPV Infections
MeSH terms: Papillomavirus Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      A randomized, double-blind and placebo-controlled phase I study to evaluate the safety and
      immunogenicity of a 9-valent Human Papillomavirus (HPV) vaccine, administered intramuscularly
      according to a 0, 2, 6-month schedule in 9 to 45 years old healthy Chinese females.
    


Intervention name(s): HPV Vaccine; Placebo
Intervention type(s): Biological; Drug
Intervention description(s): Intramuscular injection, 3 doses; Intramuscular injection, 3 doses
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Human Papilloma Virus; Papillomavirus vaccines; Cervical Cancer; Genital Warts
Free Flap Microcirculatory Monitoring Correlates to Free Flap Temperature Assessment
Condition: Flap Monitoring
Study type: Observational

Summary: 
      In case of free flap failure, time is of utmost importance as salvage rates have been
      reported to be inversely related to the time interval between the onset of ischemia and its
      clinical recognition. Consecutively, monitoring of free flaps remains of major importance.
      Currently, combined Laser-Doppler and Spectrophotometry is available to determine
      microcirculation of free flaps in reconstructive surgery as a scientific method of reliable
      assessment of flap perfusion. The investigators thought to analyze the correlation of free
      flap skin temperature and free frap microcirculation as an accurate tool of postoperative
      flap monitoring.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Patients suffering from a soft tissue defect at any location of the body receiving free
        flap soft-tissue defect coverage at the Department of Plastic, Hand and Reconstructive
        Surgery, Medical School Hannover, Germany.
A Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single and Multiple Doses of IONIS FXI-LRx in up to 84 Healthy Volunteers
Condition: Healthy Participants
Study type: Interventional
Phase: Phase 1

Summary: 
      To evaluate the safety and tolerability, pharmacokinetics, and pharmacodynamics, including
      Factor XI activity and antigen levels, activated partial thromboplastin time, prothrombin
      time and international normalized ratio of single and multiple doses of Factor XI antisense
      inhibitor administered subcutaneously to healthy volunteers.
    

Detailed description: 
      This will be a Phase 1, double-blind, randomized, placebo-controlled, dose-escalation study
      conducted at a single center. The study consists of 4 escalating single-dose cohorts (n = 8
      per cohort, randomized 3 IONIS FXI-LRx active:1 placebo), 3 escalating multiple-dose cohorts
      with weekly Study Drug (IONIS FXI-LRx or placebo) administration for 8 healthy volunteers per
      cohort, randomized 3 active:1 placebo, and 1 multiple-dose cohort of 10 healthy volunteers
      randomized 3 active:2 placebo with Study Drug administration every 4 weeks.

      Approximately 66 healthy volunteers are planned to be enrolled in this study. Additional
      healthy volunteers may be added to better assess the safety, tolerability or pharmacokinetic
      profile of IONIS FXI-LRx to meet study objectives.
    

Intervention name(s): IONIS FXI-LRx; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Ascending single and multiple doses of IONIS FXI-LRx by subcutaneous (SC) injection; Sterile Normal Saline (0.9% NaCl) calculated volume to match active comparator
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: IONIS FXI-L; Factor XI
Assess the Effect of Dehydroepiandrosterone (DHEA) or Other Androgenic Agents Over Markers of Ovarian Reserve
Condition: Healthy Women; Infertility, Female
MeSH terms: Infertility; Infertility, Female
Study type: Interventional
Phase: Phase 1

Summary: 
      This study was conducted to evaluate the effect of a continuous administration of
      dehydroepiandrosterone (DHEA) or other androgenic agents on ovarian reserve markers in women
      with diminished ovarian reserve (ROD), such as antral follicle count (AFC) and anti-Müllerian
      hormone (AMH) concentrations.
    

Detailed description: 
      Healthy women attending the clinic of the Mother and Health Research Institute (IDIMI) were
      invited to participate, if they could not become pregnant due to surgical sterilization, and
      if they presented no contraindications to use androgen therapy.

      Project Objectives :

      The general objective was to evaluate pharmacokinetic parameters of three vaginal rings
      containing DHEA, testosterone, or combination of both hormones in women.

      Secondary objectives were to assess effects on the hormonal profile, tolerability and
      incidence of adverse events.

        -  DHEA and/or, testosterone levels

        -  Estradiol, follicle stimulating hormone (FSH), sex hormone binding globulin (SHBG),
           androstenedione, morning cortisol, insulin growth factor 1 (IGF-1) levels

        -  Tolerability and safety assessment by the use of the vaginal ring.

        -  The incidence of adverse events
    

Intervention name(s): DHEA; Another Androgenic Agent (VRaA); Fixed combination of 2 androgenic agents (VR2A)
Intervention type(s): Drug; Drug; Drug
Intervention description(s): DHEA 2.2 g in vaginal ring; Testosterone 35 mg in vaginal ring; DHEA 1.5 g/testosterone 25 mg fixed combination in vaginal ring
Intervention MeSH terms: Androgens
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Supportive Care
Keywords: Hormone replacement therapy
Pharmacokinetic-Pharmacodynamic Interaction Between Four Different Single Doses of BIA 3-202 and a Single Dose of Levodopa/Carbidopa (100/25 mg)
Condition: Parkinson's Disease
MeSH terms: Parkinson Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to investigate the tolerability, pharmacokinetic profile of BIA
      3-202 and its metabolites, and the pharmacokinetic and pharmacodynamic interaction between 4
      different single doses of BIA 3-202 (50 mg, 100 mg, 200 mg and 400 mg) and a single dose of
      standard levodopa 100 mg/carbidopa 25 mg (Sinemet® 25/100) in adult male and female healthy
      volunteers.
    

Detailed description: 
      This was a single centre, double-blind, randomised, placebo-controlled, single-graded-dose,
      crossover study with five single-dose treatment periods. The washout period between doses was
      15±2 days. For each of the five treatment periods, volunteers were to be admitted at the UFH
      on the day before the treatment day. On each treatment period, the pre-dose assessment were
      to be completed, BIA 3-202/Placebo was to be administered concomitantly with the dose of
      Sinemet® 25/100 and post-dose assessments were to be completed. Subjects were discharged 30 h
      post-dose. Subjects should attend five treatment periods and were to receive a different dose
      of BIA 3-202 or placebo during each of these treatment periods.
    

Intervention name(s): BIA 3-202; Placebo; Sinemet 25/100
Intervention type(s): Drug; Drug; Drug
Intervention description(s): The study consisted of 5 treatment periods. Eligible subjects were admitted to the UFH on the morning of the day prior to receive the trial medication (dosing day) and remained in the unit for at least 30 h post-dose.
Subjects were to receive BIA 3-202 50 mg, 100 mg, 200 mg, 400 mg and placebo at 5 separate treatment periods.; Placebo dose consisted of 5 tablets matching BIA 3-202 100 mg tablets; oral route; Levodopa 100 mg/carbidopa 25 mg (Sinemet 25/100, Merck Sharp & Dohme) tablets; oral route.
Intervention MeSH terms: Carbidopa, levodopa drug combination
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Parkinson's disease; Nebicapone
A Crossover Study to Assess the Bioequivalence of Hydrocodone Bitartrate Extended-Release Tablet
Condition: Pain
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective of this study is to assess the bioequivalence of two 45-mg hydrocodone
      bitartrate extended-release tablets and one 90-mg hydrocodone bitartrate extended-release
      tablet.
    


Intervention name(s): 90 mg dose of the hydrocodone bitartrate extended-release tablet administered as either two 45-mg tablets (Treatment A) or one 90-mg tablet (Treatment B).
Intervention type(s): Drug
Intervention description(s): Each subject will receive 1 treatment during each administration period. Subjects will receive each of the 2 treatments once. There will be a minimum 14-day washout period between the 2 administrations of study drug. Treatments will be orally administered to subjects, while they are seated, at approximately 0800 (±2 hours) on the 1st day of each administration period.
Intervention MeSH terms: Hydrocodone
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Bioequivalence; Hydrocodone bitartrate extended-release tablets
Comparison of AuraGain With I-gel for Pediatric Patients
Condition: General Anesthesia
Study type: Interventional

Summary: 
      Children from 6 months to 6 years are randomly allocated into AuraGain group or I-gel group.
      After anesthetic induction without neuromuscular blocking agent, assigned device in inserted
      by skillful anesthesiologist. The outcome measures are recorded and analysed.
    


Intervention name(s): AuraGain; I-gel
Intervention type(s): Device; Device
Intervention description(s): After anesthetic induction without neuromuscular blocking agent, AuraGain is inserted.; After anesthetic induction without neuromuscular blocking agent, I-gel is inserted.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Other
Prognostic Value of Serum Cholesterol and Triglyceride in Septic and Non Septic Patients
Condition: Septic Patients; Nonseptic Patients
Study type: Observational

Summary: 
      The primary outcome of this study is to evaluate the difference between the level of serum
      cholesterol and triglyceride in septic and non septic patients in the ICU. .

      The secondary outcome will be to find correlation between the level of serum cholesterol and
      triglyceride and both Acute physiology And Chronic Health Evaluation Score (APACHE) II(19)
      and quick Sequential Organ Failure Assessment (qSOFA) score (20) and their relation to
      mortality.
    

Detailed description: 
      Type and Site of The study:

      This study will be be done at Beni-Suef university hospital SICU after approval of the local
      ethics and research committee and anesthesia department of Beni-Suef University.

      DATE AND PERIOD OF THE STUDY:

      The study will be done between June 2017 and June 2018

      Study population:

      The study population will include the patients (age range between 20 and 70)of both sex
      (septic and non septic patients e.g. trauma patients, post surgical patients) who will be
      admitted to the surgical intensive care in Beni Suef University hospital.

      Sample size estimation:

      Sample technique:

      The patients will be randomly assigned into two groups, septic patients (groups) according to
      established consensus definitions (21) or non septic patients (NS) as post surgical and
      trauma patients.

      The following data will be recorded for each patient: age, sex,weight, cause of ICU
      admission, administration of vasoactive drugs, length of ICU stay, 28-day mortality,
      administration of vasoactive drugs, days on mechanical ventilation, Acute Physiology and
      Chronic Health Evaluation II (APACHE II) scores, quick Sequential Organ Failure Assessment
      (qSOFA) scores will be recorded.

      The following laboratory data will be measured:

      cholesterol, triglyceride on days 0 (ICU admission), 1, 3, and 7, 10 and 14.
    

Intervention name(s): level of serum cholesterol and triglyceride
Intervention type(s): Diagnostic Test
Intervention description(s): other
Observational model: Other
Time perspective: Other
Sampling method: Probability Sample
Study population: 
        The study population will include the patients (age range between 20 and 70) of both sex
        (septic and non septic patients e.g. trauma patients, post surgical patients) who will be
        admitted to the surgical intensive care in Beni-Suef University hospital