bioihbjkbjnl/mcl2 huggingface dataset:
Comparison Between Sutureless and Glue Free Versus Sutured Limbal Conjunctival Autograft in Primary Pterygium Surgery
Condition: Pterygium
MeSH terms: Pterygium
Study type: Interventional

Summary: 
      Pterygium is a common ocular pathology facing ophthalmologists that has varied surgical
      management techniques and high rate of post-operative recurrence. The investigators aim was
      to compare and evaluate the safety and efficacy outcomes of those two surgical procedures in
      management of primary pterygium.
    

Detailed description: 
      Design: Prospective randomized clinical trial comparative study. Setting: Department of
      ophthalmology, Al-Minia University Faculty of medicine, Egypt.

      Methods: The study included 150 eyes of 150 patients of primary pterygium. Twenty four to 74
      years of age (mean 49 ± 12 years). Simple excision under local anesthesia was performed then
      closure of the bare sclera by sutureless and glue free conjunctival autograft in 50 eyes of
      50 patients (group 1), versus sutured free conjunctival autograft in 100 eyes of 100 patients
      (group 2).
    

Intervention name(s): Sutureless and glue free limbal conjunctival autograft; Sutured limbal conjunctival autograft
Intervention type(s): Procedure; Procedure
Intervention description(s): Simple pterygium excision under local anesthesia was performed then closure of the bare sclera by sutureless and glue free conjunctival autograft in 50 eyes of 50 patients (group 1); Simple pterygium excision under local anesthesia was performed then closure of the bare sclera by sutured limbal conjunctival autograft in 100 eyes of 100 patients (group 2).
Other intervention name(s): Sutureless and glue free LCAG; Sutured LCAG
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Pterygium surgery; Sutureless glue free conjunctival autograft; Amniotic membrane graft.
The Opioid-sparing Effect and Reduced PONV Using Propacetamol in PCA Among Patients With High Risk of PONV
Condition: PONV; Propacetamol
Study type: Interventional

Summary: 
      While Patient-controlled analgesia (PCA) has the advantage of effectively reducing the degree
      of postoperative pain, it can also affect the patient's outcome by several adverse effects
      such as postoperative nausea and vomiting (PONV). Especially for high risk group of patients
      for PONV, the ideal regimen for sufficient analgesia with minimal adverse effect needs to be
      sought. Propacetamol is known for its effective, rapid analgesia, opioid-sparing effect, and
      is used widely for post operative pain management. This study aims to see the opioid-sparing
      effect and the degree of PONV when propacetamol is added to PCA for high risk PONV patients.
    


Intervention name(s): Propacetamol; PCA regimen
Intervention type(s): Drug; Drug
Intervention description(s): total 4g of Propacetamol added to patient's PCA regimen
Intervention MeSH terms: Propacetamol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Prevention
Keywords: Nausea; Vomiting
Changes in Pituitary Iron and Volume With Deferasirox
Condition: Iron Overload
MeSH terms: Iron Overload
Study type: Observational

Summary: 
      Despite continuing advances in iron chelation therapy, iron toxicity of endocrine glands,
      particularly the pituitary gland, remains common in patients with transfusion dependent
      anemias. We would like to establish accurate population norms of pituitary R2 and volume and
      understand the progression of pituitary iron in transfused patients on Deferasirox.
    


Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Transfusion Dependent Anemia
A Safety and Efficacy Study of 552-02 in Subjects With Dry Mouth Associated With Sjogren's Syndrome
Condition: Dry Mouth Associated With Sjogren's Syndrome; Xerostomia
MeSH terms: Sjogren's Syndrome; Xerostomia; Syndrome
Study type: Interventional
Phase: Phase 2

Summary: 
      This clinical study is to determine whether daily administration of a formulation of 552-02
      improves the dry mouth condition in subjects with primary Sjögren's syndrome.
    

Detailed description: 
      The primary objective of this clinical study is to determine whether daily administration of
      an oromucosal formulation of 552-02 improves the global assessment of dry mouth, as assessed
      by visual analog scale (VAS), in subjects with primary Sjögren's syndrome.

      The secondary objectives of this study are as follows:

        -  To evaluate the safety of daily administration of an oromucosal formulation of 552-02 in
           subjects with primary Sjögren's syndrome.

        -  To evaluate whether administration of an oromucosal formulation of 552-02 improves the
           subjective measurement of 6 different salivary functions, as measured using VAS, in
           subjects with primary Sjögren's syndrome.
    

Intervention name(s): Placebo; 552-02
Intervention type(s): Drug; Drug
Intervention description(s): Placebo to match oromucosal formulation of 552-02; The oromucosal formulation of 552-02 contains 552-02 (25 μg/mL), surfactant, flavoring agents, a humectant, and preservatives.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Dry mouth; Sjogren's syndrome; Xerostomia
Study of IL-22 IgG2-Fc (F-652) for Subjects With Grade II-IV Lower GI aGVHD
Condition: Acute Graft vs Host Disease
MeSH terms: Graft vs Host Disease
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      A Phase IIa single arm open-label study to investigate the safety, tolerability, and PK of
      F-652 in combination with systemic corticosteroids in subjects who have undergone
      Hematopoietic Stem Cell Transplantation (HSCT) and have newly diagnosed grade II-IV lower GI
      acute Graft Verses Host Disease (aGVHD). Treatment with F-652 will be once a week for 4
      weeks, with post treatment follow up visits on days 28, 56, 180 and 365.
    

Detailed description: 
      This is a Phase IIa single arm open-label study to investigate the safety, tolerability, and
      PK of F-652 in combination with systemic corticosteroids in subjects who have undergone HSCT
      and have newly diagnosed grade II-IV lower GI aGVHD. The HSCT may be derived from bone
      marrow, peripheral blood stem cells, or cord blood. The PK of F-652 in this subject
      population will be investigated. Subjects may be replaced if subject withdrawal is not
      related to safety or treatment response.

      F-652 will be administered in conjunction with prednisone (or equivalent) at the time of the
      onset of clinical symptoms consistent with GI and/or liver aGVHD. Prednisone (or equivalent)
      will be given at a dose of 2 mg/kg/day and tapered as per protocol.

      F-652 will be administered intravenously at a rate of 100 mL/hour for one hour once per week
      for four weeks. A total of 4 doses will be administered at a dose of 45 μg/kg each. Subjects
      will be followed for safety and efficacy through Day 180, and subject survival status will be
      collected at Day 365.

      In the first stage of the trial, a total of 16 subjects will be enrolled. If six or fewer
      have a Day 28 treatment response, the trial will close due to a lack of efficacy. If seven or
      more have a response, an additional 11 subjects will be enrolled into study for a total
      sample size of 27. During the course of a subject's therapy, dose reduction may occur on an
      individual basis as per protocol.
    

Intervention name(s): Recombinant Human Interleukin-22 IgG2-Fc (F-652); Systemic Corticosteroids
Intervention type(s): Drug; Drug
Intervention description(s): IV infusion of reconstitution lyophilized F-652.; Prednisone (or equivalent) at the time of the onset of clinical symptoms consistent with GI and/or liver aGVHD, as per the standard of care. Prednisone (or equivalent) will be given at a dose of 2 mg/kg/day and tapered as needed.
Other intervention name(s): IL-22
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Effects of Breathing Exercises on Pain, Range of Motion and Neck Disability in Patients With Cervical Spondylosis
Condition: Cervical Spondylosis
MeSH terms: Spondylosis
Study type: Interventional

Summary: 
      A randomized controlled trial was conducted on 72 diagnosed patients with cervical
      spondylosis at University of Lahore Teaching hospital. The study was completed within 9
      months after the approval of synopsis. Patients who fulfill the inclusion criteria were
      identified by individual physiotherapist and were enrolled for particular study. Informed
      written consent was be taken by the patients and were randomly allocated into two groups. The
      total numbers of sessions were 12 (3 sessions per week). The study was single blinded. The
      assessor was unaware of the treatment given to both groups.

      Control group received only routine physical therapy. This includes thermotherapy,
      trans-cutaneous electrical nerve stimulation, neck isometrics and stretching that includes 12
      sessions and three times per week.

      Experimental group received routine physical therapy along with breathing exercises. This
      includes thermotherapy, trans-cutaneous electrical nerve stimulation, neck isometrics and
      stretching that includes 12 sessions and three times per week.

      Baseline data was collected before first treatment then after 4th, 8th and 12th session.

      The outcome measures were neck pain, ROM, neck disability and quality of life and were
      analyzed by using SPSS 26 and then results and conclusion were drawn.
    


Intervention name(s): Diaphragmatic and pursed lip breathing; Routine Physical Therapy
Intervention type(s): Other; Other
Intervention description(s): Breathing exercises were performed. Two breathing techniques were applied to the participants. Diaphragmatic and pursed lip breathing were intervened along with routine physical therapy.; Routine physical therapy exercises were performed in which neck isometrics and neck range of motion exercises were performed
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized Controlled Trial
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Vaccination of Metastatic Breast Cancer Patients With a CD80-modified Allogeneic Cancer Cell Line (KS2422)
Condition: Metastatic Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      In the last few years there has been a great attempt to develop active immunotherapies for
      breast cancer patients (BCPs) using undefined as well as selected antigens to activate tumor
      specific T-lymphocytes. The purpose of this phase-I study was to determine the safety and
      feasibility of vaccinations with an allogeneic breast cancer cell line, KS24.22, genetically
      modified to express CD80 and Her-2/neu, and to evaluate the efficacy of inducing tumor
      antigen-specific immune responses in human leukocyte antigen(HLA)-A*02-matched patients with
      metastatic breast cancer.
    

Detailed description: 
      The trial was designed as an open label phase-I. Informed consent was given twice by the
      patients (1st for HLA-typing, 2nd for participation in the vaccination trial).

      The first four vaccinations, which were given every two weeks, were followed by four monthly
      vaccinations. Additional vaccinations were permitted on request for patients who exhibited
      stable disease (SD).

      Immediately before administration, KS24.22 cells were thawed and lethally irradiated. KS24.22
      cells were adjusted to 10E7/ml in Ringer-Lactate-solution, transferred to 1 ml syringes and
      stored on ice until injected within a time frame of 2h. Vaccinations were given i.d. in the
      thigh with a total volume of 1 ml divided between two injection sites.
    

Intervention name(s): KS24.22 cells
Intervention type(s): Biological
Intervention description(s): The first four vaccinations, which were given every two weeks, were followed by four monthly vaccinations. Additional vaccinations were permitted on request for patients who exhibited stable disease (SD).
Immediately before administration, KS24.22 cells were thawed and lethally irradiated (200 gray). KS24.22 cells were adjusted to 107/ml in Ringer-Lactate-solution, transferred to 1 ml syringes and stored on ice until injected within a time frame of 2h. Vaccinations were given i.d. in the thigh with a total volume of 1 ml divided between two injection sites.
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: metastatic breast cancer; breast cancer stage IV; vaccination; CD80; immunotherapy
Safety of Stem Cells Intrabronchial Instillation for Silicosis
Condition: Chronic and Accelerated Silicosis
MeSH terms: Silicosis
Study type: Interventional
Phase: Phase 1

Summary: 
      The aim of this study was to analyze the safety, pulmonary function, and quality of life data
      of patients with silicosis treated with intrabronchial instillation of bone marrow derived
      mononuclear cells (BMDMC, 2x107) through bronchoscopy.
    

Detailed description: 
      This study will perfume the safety (Phase I) study of 10 patients with silicosis treated with
      intrabronchial instillation of autologous bone marrow derived mononuclear cells (BMDMC,
      2x107) through bronchoscopy. The inclusion criteria is: age between 18-50, chronic and
      accelerated silicosis, characterized with a fibrotic increase in the last two years, FEV1
      <60% and > 40%, FVC > 60% and SaO2 >90%, while the exclusion criteria were: smoking, active
      tuberculosis or other infections, cancer, auto-immune disorders, hematological, hepatic or
      cardiac diseases, and pregnancy. All patients will be subjected to clinical examination,
      answered questionnaires of quality of life (SGRQ and SF36) and dyspnea score (Borg),
      performed high resolution CT of thorax, pulmonary function tests with DLCO and 6-minute walk
      test and lung perfusion scintigraphy before and 7, 30, 60, 180 and 360 days after treatment.

      For each patient, 2×107 cells will be labeled with 99mTc. Briefly, 500 μl of sterile SnCl2
      solution is added to the cells and the mixture is incubated at room temperature for 10 min.
      Forty-five mCi of 99mTc is then added and incubation continued for another 10 min. After
      centrifugation (500×g for 5 min), the supernatant is removed and the cells are washed in
      saline solution. The pellet was also resuspended in saline solution. Viability of the labeled
      cells was assessed by the trypan blue exclusion test, and was estimated to be greater than
      93% in all cases. Labeling efficiency (%) was calculated by the activity in the pellet
      divided by the sum of the radioactivity in the pellet plus supernatant and was estimated to
      be greater than 90% in all cases. Whole body and planar scans will be performed 2 and 24h
      after instillation. Perfusion scintigraphy will be performed before and 30, 60, 120 and 180
      days after BMDMC therapy. For regional analysis the right and left lungs will be divided into
      three zones: base, midzone, and apex.
    

Intervention name(s): Autologous cell transplantation
Intervention type(s): Other
Intervention description(s): Intrabronchial Instillation Of Bone Marrow Derived Mononuclear Cells
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: pulmonary, silicosis, chronic and accelerated silicosis, autologous transplantation; bone marrow cells, stem cells, cell therapy
Pre-FIBRe Study: Predeterminants of Fibre Induced Bloating Response.
Condition: Functional Bloating (Disorder)
Study type: Interventional

Summary: 
      This study is an exploratory study aimed at gaining a greater understanding of the cause of
      abdominal bloating in response to two distinct fibre types. This is a single-center,
      interventional double blinded randomized cross-over study. Each participant will consume each
      of the study products (placebo, fibre 1 and fibre 2) for a 7-day period with a 3-week washout
      period in between. Outcomes will be measured before and after each intervention period.
    

Detailed description: 
      The investigators have 4 hypotheses linked to 4 research questions that will be answered by
      this research:

      Hypothesis 1: participants with self-reported functional bloating in response to either
      fibre-1 or fibre-2, but not both, will respond symptomatically to fibre-1 or fibre-2, defined
      as 'fibre-1 responders' and 'fibre-2 responders'.

      Hypothesis 2: participants with functional bloating who are 'fibre-1 responders' will be
      distinguishable from 'fibre-1 non-responders', and 'fibre-2 responders' will be
      distinguishable from 'fibre-2 non-responders', based upon faecal microbial profiles
      identified using faecal metagenomics, transcriptomics and metabolites at baseline and
      following the fibre-1 and fibre-2 interventions.

      Hypothesis 3: the microbiota, clinical and nutritional profiles of participants with
      functional bloating will be interrelated and these relationships will be distinguishable
      between 'fibre-1 responders', 'fibre-1 non-responders', and 'fibre-2 responders' and 'fibre-2
      non-responders'.

      Hypothesis 4: participants with visceral hypersensitivity will have different faecal
      microbiota and will be more likely to be a 'fibre-1 responders' or 'fibre-2 responders' than
      'non-responders'.

      Participants in the trial will take three different dietary substances, each at a dose of 8
      grams per day (split into two serves of 4 gram doses) for 7-days in a double-blinded
      randomised order with a 3-week washout period in between each intervention. The products are
      provided in powdered format and will be mixed with water before drinking. The products being
      provided are glucose, and fibre-1 or fibre-2 (all extracts of commonly consumed food
      products).
    

Intervention name(s): Fibre 1; Fibre 2; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): Food derived fibre presented as a white powder; Food derived fibre presented as a white powder; Simple sugar, presented as a white powder
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: cross-over study
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Polyethylene Body Bags as an Alternative to Radiant Heat Lamp During the Neonatal Adaptation in Infants Older Than 29 Weeks
Condition: Neonatal Adaptation
Study type: Interventional
Phase: Phase 3

Summary: 
      INTRODUCTION: Hypothermia in the newborn causes morbid conditions. In developing countries in
      the basic technology for neonatal adaptation may not be available. Polyethylene bags may be
      an alternative to lamp radiant heat to prevent hypothermia OBJECTIVE: To characterize the
      differences between babies undergoing body bag with polyethylene or conventional drying
      during neonatal adaptation in the Hospital de la Victoria and Hospital de Engativá, Bogotá,
      Colombia, 2013.

      MATERIALS AND METHODS: parallel-group randomized controlled trial. Groups: dried conventional
      (control) or polyethylene body bag (intervention). The procedure lasted 10 minutes, the bag
      body and / or radiant heat lamp was removed. Environment temperature and humidity,
      temperature in the body segments 1-5-10-60-120 minutes and APGAR was measured. Statistical
      Analysis: Descriptive bivariate statistical inference and calculated. Risk ratio (RR) and
      confidence intervals (CIs) were determined using contingency tables for risk analysis of the
      outcome. The study was approved by the hospital ethics committee of victory.
    


Intervention name(s): polyethylene plastic bag; Conventional treatment
Intervention type(s): Device; Device
Intervention description(s): Inborn neonates with both a gestational age >29 weeks were randomized 1:1 to either a standard thermoregulation protocol or placement of a Poliethylene body bag since birth to 10 minutes after birth.; Infants randomized to the control group received standard hospital care newborn. This included immediate drying, skin-to-skin contact, early and exclusive breast feeding, postponed bathing, bundling, and radiant warmer. While waiting for criteria cord clamping, the environment humidity and temperature and segment and rectal temperature of the newborn were measure. It was repeated at 1-5- 10-60 and 120 minutes. After clamping, the newborn were positioned in a radiant warmer, and completed the drying process. Umbilical prophylaxis, vitamin K1 application, initial physical examination and ocular prophylaxis are performed. The infants were swaddled in blankets provided by the mother, the head was covered with a hat, and the infants were placed either in an open crib or under a radiant warmer as necessary and available. The same process was done in surgery room in case of cesarean.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Study of H2 Antagonist and a Proton Pump Inhibitor of Selpercatinib in Healthy Participants
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The main purpose of this study is to learn about how H2 antagonist (ranitidine) and proton
      pump inhibitor (PPI) (omeprazole) affect Selpercatinib in healthy participants. Information
      about safety and tolerability will be collected. The study will last up to about 9 weeks,
      inclusive of screening period.
    


Intervention name(s): Selpercatinib; Ranitidine; Omeprazole
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Administered orally.; Administered orally.; Administered orally.
Other intervention name(s): LY3527723; LOXO-292
Intervention MeSH terms: Omeprazole; Ranitidine; Ranitidine bismuth citrate
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Alternate-Day Buprenorphine Administration. Phase VI - 7
Condition: Opioid-Related Disorders
MeSH terms: Opioid-Related Disorders
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine if four times a subject's daily maintenance dose
      will hold for 96 hours without changes in agonist and antagonist effects.
    


Intervention name(s): Buprenorphine
Intervention type(s): Drug
Intervention MeSH terms: Buprenorphine
Masking: Double
Primary purpose: Treatment
Renal Impairment Study With ASP1941
Condition: Type 2 Diabetes Mellitus
MeSH terms: Renal Insufficiency; Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      A study to investigate if the pharmacokinetics of ASP1941 is different in Type 2 Diabetes
      Mellitus (T2DM) patients with different grades of renal failure compared with T2DM patients
      with normal renal function and healthy volunteers.
    


Intervention name(s): ASP1941
Intervention type(s): Drug
Intervention description(s): Oral
Intervention MeSH terms: Ipragliflozin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Renal Impairment; ASP1941; Pharmacokinetics