bioihbjkbjnl/mcl2 huggingface dataset:
Dienogest for Treatment of Adenomyotic Uteri
Condition: Adenomyosis
MeSH terms: Adenomyosis
Study type: Interventional

Summary: 
      Adenomyosis is a common disease in women aged 40-50 years. It associates with dysmenorrhea
      and menorrhagia. Hysterectomy was considered the main treatment that could definitively cure
      this disease. Other treatment options are increasingly offered, including hormonal
      suppression with gonadotropin-releasing hormone agonists or danazol and endometrial ablation.
      However, deep adenomyosis responds weakly to the above treatment options, which are commonly
      not considered for long-term management because of the associated side effects.

      Dienogest is a progestin medication which is used in birth control pills and in the treatment
      of endometriosis and adenomyosis. Low-dose combined oral contraceptive (COC) pills have been
      widely used as the primary treatment for menorrhagia. COCs can also be used to induce
      endometrial atrophy and to decrease endometrial prostaglandin production, which can
      consequently improve menorrhagia and dysmenorrhea that are associated with adenomyosis
    


Intervention name(s): Dienogest group; Gestodene-Ethinyl Estradiol; Ultrasound; visual analogue scale
Intervention type(s): Drug; Drug; Radiation; Other
Intervention description(s): VISANNE 2MG Tablet once daily; Gynera tablet once daily; ultrasound assessment of uterine volume; visual analogue scale for assessment of pain
Intervention MeSH terms: Dienogest; Ethinyl Estradiol; Gestodene; Femovan; Estradiol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Galectin-3 as a Biomarker in Patients With Chagas Disease
Condition: Chagas Disease
MeSH terms: Chagas Disease
Study type: Observational

Summary: 
      The purpose of this study is to analyze the efficacy of Galectin-3 as a biomarker on the
      Chagas Disease prognosis. This analysis will be done through the correlation between the
      plasmatic levels of this molecule with functional and laboratory tests.
    

Detailed description: 
      Previous studies indicate that activated macrophages secrete Galectin-3, a molecule that is
      involved in the development of fibrosis and tissue rearrangement in the liver, kidney and the
      heart. Its plasmatic levels are increased on patients with acute decompensated heart failure.
      These observations suggest that measuring levels of Galectin-3 in patients with cardiac
      diseases can be useful to determine their prognosis. To investigate the role of this new
      biomarker in Chagas Disease, we will study a Chagas Disease population (including patients
      with the indeterminate and cardiac form of the disease). The assessment of the prognostic
      value of Galectin-3 will be done through the comparison between its plasmatic levels and each
      patients's clinical evaluation, disease severity, inflammatory biomarkers and cardiac
      function tests.

      The patients included in the study must at first sign the written consent. They shall be
      accompanied in the specialized outpatient clinics for Chagas disease - Hospital São Rafael -
      Centro de Biotecnologia e Terapia Celular. They will be submitted to several tests,
      including:

        -  Collection of Blood samples for biochemical analysis;

        -  Electrocardiogram;

        -  Holter Electrocardiogram;

        -  Echocardiogram;

        -  Treadmill Test;

        -  X-Ray Imaging;

        -  Magnetic Resonance Imaging;

        -  Evaluation of the quality of life through the application of questionnaires (SF 36 and
           the Minnesota Living With Heart Failure Questionnaire).
    

Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Tertiary Hospital
      
Biospecimen description: 
      Plasma, Serum, Whole Blood
    
Keywords: Galectin-3; Chagas disease; Biomarkers
Identifying and Treating Physical Function Impairment in Elders
Condition: Physical Activity; Physical Impairment
Study type: Interventional

Summary: 
      Sedentary older adults are more likely to develop physical function impairments than active
      older adults. Physical function measured by slow usual gait speed predicts the risk of future
      falls, disability, institutionalization and mortality. Behavioral physical activity
      interventions have improved physical activity and physical function, but have not generally
      been implemented where they may have the most impact -- primary care settings. In part, this
      is due to the limited time and training for clinical staff to screen for physical function
      impairment and to treat with physical activity counseling. The proposed scientific goal is to
      overcome these barriers by adapting an evidence-based screening tool and telephone-based
      physical activity intervention into primary care settings.

      Aim1: Among older adults who screen positive for physical function impairment, to determine
      the estimated intervention effect size of a 12-week behavioral intervention on physical
      activity and physical function.

      Hypothesis 1a: Physical activity levels will increase more in the intervention vs. usual care
      group.

      Hypothesis 1b: Physical function will increase more in the intervention vs. usual care group.

      Aim 2: Among Aim 1 participants and clinical staff who deliver the functional screening and
      Aim 1 intervention, to evaluate standard implementation science process metrics of reach,
      acceptability, and implementation
    


Intervention name(s): Behavioral Counseling
Intervention type(s): Behavioral
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Adults; Elderly
Pilot Trial to Evaluate the Effect of Vitamin D on Melanocyte Biomarkers
Condition: Melanoma, Skin
MeSH terms: Melanoma
Study type: Interventional

Summary: 
      The purpose of this study is to determine the signaling pathways and changes in gene
      expression in melanocytes of subjects with a history of non-melanoma skin cancer who are
      exposed to oral vitamin D. If vitamin D is found to inhibit a signaling pathway involved in
      the development of melanoma such as BRAF, a protein involved in cell proliferation, then oral
      vitamin D could be explored further as a chemoprevention for melanoma skin cancer.
    

Detailed description: 
      Background:

      Vitamin D is an important hormone that has multiple genetic effects in different tissue types
      that are mediated by signaling through the vitamin D receptor.

      Recent studies have shown that vitamin D signaling results in decreased innate immunity and
      increased adaptive immunity.

      Multiple epidemiologic studies have suggested that vitamin D may play a role in decreasing
      the risk of developing multiple types of cancer, including skin cancer.

      In the context of the relative success of novel immune-related therapies including PD1
      inhibitors, which improves immuno-surveillance, and ipilimumab, which suppresses T cell
      response, there is increased promise for treatment strategies that activate innate immunity.
      This led us to ask the question of whether vitamin D could increase immune surveillance for
      melanoma via increased activity of the adaptive immune system.

      Prior studies performed by our group and others have suggested that vitamin D may play a role
      in decreasing melanoma risk. An epidemiologic study from the Women's Health Initiative showed
      that women with a prior history of NMSC who received calcium and vitamin D supplementation
      had a lower risk of subsequently developing melanoma. At the same time, women with a lower
      serum vitamin D level had a higher risk of developing melanoma. Furthermore, a recent
      clinical study showed that vitamin D supplementation increases serum vitamin D levels and
      ultimately results in increased vitamin D receptor signaling in benign nevi.

      Taken together, this findings led us to ask whether oral vitamin D supplementation could
      impact immune signaling in benign nevi and potentially underpin a theoretical
      chemo-preventive role for vitamin D in melanoma.
    

Intervention name(s): Vitamin D3; placebo and vitamin D
Intervention type(s): Drug; Drug
Intervention description(s): 4,000 IU oral vitamin D3
Other intervention name(s): 25-hydroxy D3; inactive tablet and 25-hydroxy D3
Intervention MeSH terms: Vitamin D; Ergocalciferols; Cholecalciferol; Vitamins
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: quality of life
Study of Ampion for the Treatment of Adult COVID-19 Patients Requiring Oxygen Supplementation
Condition: COVID-19
MeSH terms: COVID-19
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a Phase 1 randomized study to evaluate the safety, tolerability and efficacy of IV
      Ampion in improving the clinical course and outcomes of patients hospitalized with COVID-19
      infection who require supplemental oxygen.
    


Intervention name(s): Ampion; Standard of Care
Intervention type(s): Biological; Other
Intervention description(s): Ampion, administered by intravenous infusion; Standard of Care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Near-infrared Spectroscopy in Cerebral Oxygenation Monitoring in Full Term Neonates
Condition: Cerebral Oxygenation in Full-term Neonates
Study type: Observational

Summary: 
      The aim of the study was to assess the values of cerebral oxygenation in full-term neonates
      in the first 10 minutes of life and to compare these values between neonates delivered by
      normal vaginal delivery and those delivered by elective cesarean section.
    


Intervention name(s): Near-infrared spectroscopy
Intervention type(s): Device
Intervention description(s): Near-infrared spectroscopy (NIRS) offers the non-invasive continuous monitoring of cerebral oxygenation and perfusion. Cerebral regional oxygen (crSO2) measured via NIRS represents a mixed tissue saturation value, thus enabling information on the balance of cerebral oxygen delivery and oxygen consumption.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Full term neonates born either via normal vaginal delivery or elective cesarean section.
A Dose-finding Phase IIb Study With AZD0865 and Esomeprazole in GERD Patients With Erosive Esophagitis.
Condition: GERD With Erosive Esophagitis
MeSH terms: Esophagitis
Study type: Interventional
Phase: Phase 2

Summary: 
      The primary objective is to compare the efficacy between three doses of AZD0865 (25, 50 and
      75 mg).

      The secondary objectives are to compare the efficacy between the three doses of AZD0865 and
      esomeprazole 40 mg and to evaluate the safety and tolerability of AZD0865.
    


Intervention name(s): AZD0865
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: GERD with erosive esophagitis
OSTAP Versus TAP for Postoperative Pain Management in Laparoscopic Cholecystectomy Patients
Condition: Pain Postoperative
MeSH terms: Pain, Postoperative
Study type: Interventional

Summary: 
      The aim of the study is to compare the effectiveness and opioid sparing effects of TAP and
      OSTAP in patients undergoing laparoscopic cholecystectomy.
    

Detailed description: 
      Patients undergoing laparoscopic cholecystectomy were separated into 3 groups. Group 1:
      Received TAP block Group 2: Received OSTAP Group 3: No Block Standard General Anesthesia was
      induced and maintained in all patients. At the end of the operation patient controlled
      analgesia with morphine was applied to all patients.

      Pain scores were evaluated at 0,2,4,6,12,24 hours postoperatively. Total morphine consumption
      and pain scores were compared.
    

Intervention name(s): TAP; OSTAP
Intervention type(s): Procedure; Procedure
Intervention description(s): Classic TAP block performed through the petit triangle (the anterior axillary line and iliac crest); Modified TAP (OSTAP) block performed from the medial of linea semilunaris applying local anesthetic to the area between xiphoid and anterior iliac crest.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Other
Keywords: TAP OSTAP Postoperative pain
Dose Escalation Study of OMP-54F28 in Combination With Sorafenib in Patients With Hepatocellular Cancer
Condition: Hepatocellular Cancer; Liver Cancer
MeSH terms: Liver Neoplasms; Carcinoma, Hepatocellular
Study type: Interventional
Phase: Phase 1

Summary: 
      This is an open-label Phase 1b dose-escalation study to assess the safety, tolerability, and
      PK of OMP-54F28 when combined with sorafenib. OMP-54F28 will be administered IV on Day 1 of
      each 21-day cycle. The planned dose levels of OMP-54F28 are 5 and 10 mg/kg. Depending on
      safety in this study, additional lower or intermediate dose levels may be evaluated.
    

Detailed description: 
      Depending on emerging safety data from the Phase 1a study 54F28-001 with continuing dose
      escalation, additional higher dose levels of OMP-54F28 may be evaluated in this study.
      Alternative dosing schedules of OMP-54F28 may be explored based on emerging nonclinical and
      clinical data for safety, PD, PK and efficacy. The starting dose for a new dosing schedule
      will be chosen to result in an AUC equivalent to the highest dose level that cleared on the
      previously studied dosing schedule. No dose escalation of OMP-54F28 will be allowed within a
      dose cohort. Sorafenib 400 mg will be given orally twice daily (PO BID). Sorafenib dosing
      schedules with a total daily dose <800 mg (e.g. Sorafenib 400 mg once daily) may be evaluated
      in this study depending on emerging safety data from this study.
    

Intervention name(s): OMP-54F28 with Sorafenib
Intervention type(s): Drug
Other intervention name(s): OMP-54F28; Sorafenib
Intervention MeSH terms: Sorafenib; Immunoglobulin Fc Fragments
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Hepatocellular Cancer; Liver Cancer
Learning Curve of Aortic Arch Replacement Surgery in Chinese Mainland With Stanford Type A Aortic Dissection
Condition: Cumulative Sum Learning Curves; Stanford Type A Aorta Dissection
MeSH terms: Aortic Dissection
Study type: Observational

Summary: 
      stanford type A aortic dissection is the most common cause of death caused by aortic disease
      in Chinese mainland. Patients who are hospitalized need immediate surgical
      treatment.Emergency aortic arch replacement is difficult and risky. Different surgical
      methods have different effects on postoperative prognosis. Aortic arch replacement is divided
      into total-arch replacement (Sun's operation) and hemi-arch replacement. In this study, and
      the learning Curve of Aortic Arch Replacement Surgery was evaluated with cumulative cum
      curve.
    


Observational model: Other
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        age between 18 years and 65 years who underwent standford type A aorta dissection
Does Glidescope Video Laryngoscope is Related to Less Hemodynamic Response?
Condition: Blood Pressure
Study type: Interventional

Summary: 
      Laryngoscopy and endotracheal intubation causes significant hemodynamic response and thus
      presents an increased risk for patients undergoing cardiac bypass surgery. Prevention or
      reduction of this increment is important for hemodynamic control. In this randomized single
      blind study, the aim of this study is to compare the hemodynamic responses of two different
      laryngoscopy techniques with Glidescope and Macintosh laryngoscope in coronary cardiac bypass
      surgery patients.
    

Detailed description: 
      Laryngoscopy and endotracheal intubation causes significant hemodynamic response and thus
      presents an increased risk for patients undergoing cardiac bypass surgery. Prevention or
      reduction of this increment is important for hemodynamic control. In this randomized single
      blind study, the aim of this study is to compare the hemodynamic responses of two different
      laryngoscopy techniques with Glidescope and Macintosh laryngoscope in coronary cardiac bypass
      surgery patients. After induction with our institutional protocol for cardiac bypass surgery,
      hemodynamic data including heart rate, systolic and diastolic arterial pressure data will be
      recorded. Time for intubation, age, sex, ASA status data will also be recorded.
    

Intervention name(s): Glidescope; Macintosh Laryngoscope
Intervention type(s): Device; Device
Intervention description(s): This standard GlideScope (GS) technique involves a midline laryngoscopy followed by insertion of a styletted endotracheal tube, once an adequate view of the vocal cords is achieved.; This technique involves a laryngoscopy followed by insertion of a styletted endotracheal tube, once an adequate view of the vocal cords is achieved.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Glidescope; Cardiovascular surgery; Macintosh Laryngoscope; Hemodynamic response; Anesthesia
Retrospective Analysis of Spray Skin Treats for Severe Burns
Condition: Morality; Skin Graft Complications
Study type: Observational

Summary: 
      This study investigated the efficacy of novel approach spray skin for extensive severe burns
      treatment.
    

Detailed description: 
      Burns are a global public health problem. This study investigated the efficacy of novel
      approach spray skin (autologous skin cell suspension combined with split-thickness skin
      grafting, STSG) for extensive severe burns treatment.

      We performed a real-world retrospective analysis of extensive burns patients (> 50% TBSA)
      from our hospital last 10 years.
    

Intervention name(s): spray skin; Control group
Intervention type(s): Procedure; Procedure
Intervention description(s): The patients who used the autologous skin cell suspension combined with skin grafting.; The patients who used skin grafting.
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        severe burns patients with > 50% TBSA
      
Keywords: spray skin, severe burn, microskin grafting
Low and High Doses of Prophylactic Vitamin D in Prevention of Osteopenia of Prematurity
Condition: Osteopenia of Prematurity
MeSH terms: Bone Diseases, Metabolic; Premature Birth
Study type: Interventional
Phase: Phase 2

Summary: 
      In this study the effects of low and high doses of prophylactic vitamin D on biochemical and
      radiological manifestations of osetopenia of prematurity will be tested.
    

Detailed description: 
      The study will be conducted on (80) preterm infants that fulfill the eligibility criteria and
      delivered at Alexandria University Maternity Hospital (AUMH).
    

Intervention name(s): Low Dose Vitamin D; High Dose Vitamin D
Intervention type(s): Drug; Drug
Intervention description(s): Patients will receive a 200 IU/d vitamin D since they tolerate full enteral nutrition.; Patients will receive 1600 IU/d vitamin D since they tolerate full enteral nutrition.
Other intervention name(s): 1,25-Dihydroxycholecalciferol; 1,25-Dihydroxycholecalciferol
Intervention MeSH terms: Vitamin D; Ergocalciferols; Cholecalciferol; Dihydroxycholecalciferols; Calcitriol; Vitamins
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
A Trial of the Jejunal Diversion Procedure
Condition: Diabetes; Obesity
Study type: Interventional

Summary: 
      This is a single site trial to assess metabolic effects in subjects after a Jejunal Diversion
      procedure was performed.
    

Detailed description: 
      The Jejunal Diversion procedure is an adaptation of a jejuno-jejunostomy, which is a surgical
      procedure often used to address a mix of pathological conditions. The safety of the Jejunal
      Diversion procedure is not in question, but rather understanding the gastrointestinal
      signalling effects. Up to 25 eligible subjects will be enrolled into the trial. Enrollment
      will stop once 15 subjects have undergone the Jejunal Diversion procedure
    

Intervention name(s): Jejunal Diversion
Intervention type(s): Procedure
Intervention description(s): The jejuno-jejunostomy surgical procedure is a well-known general surgical operation performed for multiple acute and chronic conditions including Crohn's disease, ovarian cancer, and small bowel obstruction. The jejunal diversion procedure is an adaptation of a jejuno-jejunostomy. The proximal end of the anastomosis is approximately 100 cm distal from the ligament of Treitz. The distal end of the anastomosis is approximately 250 cm proximal from the ileocecal junction.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Effect of Nebulized Budesonide and Oral Corticosteroids on Wheezing Episode Relapse in Children
Condition: Asthma
MeSH terms: Respiratory Sounds
Study type: Interventional
Phase: Phase 4

Summary: 
      Subjects aged 1-8 years who have been discharged from the emergency department/outpatient
      care facility with a diagnosis of asthma/bronchospasm/wheezing after usual standard care will
      be enrolled into this open-label, randomized, parallel-group study to compare the efficacy of
      nebulized budesonide and oral corticosteroids in preventing asthma exacerbation relapse rates
      during the 21-day follow-up period.
    

Detailed description: 
      Secondary outcomes include urinary cortisol-creatinine rations, symptom severity scores and
      peak flow rates.
    

Intervention name(s): Nebulized Budesonide; Usual care (albuterol with or without oral steroid)
Intervention type(s): Drug; Drug
Intervention description(s): Subject is treated with nebulized budesonide 0.5 BID for 3 weeks; Subject is treated with usual care as prescribed by the doctor (normally albuterol with or without oral steroid)
Intervention MeSH terms: Budesonide; Albuterol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Asthma
Development of New MRI Pulse Sequences for Probing Lung Function in Volunteers With Hyperpolarised 3He Gas
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      To develop techniques with MRI of Helium-3 gas to give functional images of the lungs. The
      goal is to test a single breath-hold functional 3-He MRI pulse sequence with sensitivity to
      multiple functional aspects of the luncg physiology. A group of 20 healthy volunteers willbe
      recruited from the local research group and the results compared with existing methods that
      require seperate breath-holds of 3He gas
    


Intervention name(s): polarised 3 helium
Intervention type(s): Other
Intervention description(s): 1 inhalation (= 1 litre)
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other