bioihbjkbjnl/mcl2 huggingface dataset:
Atezolizumab Plus Bevacizumab Versus Sintilimab Plus Bevacizumab With TACE and HAIC in Unresectable Hepatocellular Carcinoma
Condition: Hepatocellular Carcinoma
MeSH terms: Carcinoma; Carcinoma, Hepatocellular
Study type: Observational

Summary: 
      Systemic therapy is the primary option for managing advanced hepatocellular carcinoma (HCC).
      The combination of atezolizumab and bevacizumab (A+B) has emerged as the first-choice
      treatment for advanced HCC(IM brave 150). The ORIENT-32 study, also reported an ORR of 24%
      for sintilimab plus a bevacizumab biosimilar (S+B) versus 8% for sorafenib, with
      significantly longer OS and PFS. Based on those therapeutic advantages over sorafenib, both
      the A+B and S+B regimens were approved as first-line treatment options for advanced HCC in
      China. These two trials had very similar designs but included different target populations.
      Our previous studies have demonstrated that a novel treatment approach combining
      transarterial chemoembolization (TACE) with hepatic arterial infusion chemotherapy (HAIC) has
      high efficacy in patients with potentially resectable HCC or portal vein tumor thrombus.
      However, it remains unknown whether combining immune checkpoint inhibitors and macromolecular
      VEGF-targeted therapy with transvascular local interventions could improve patient prognosis
      in uHCC.
    


Intervention name(s): Atezolizumab combined with Bevacizumab; Sintilimab combined with Bevacizumab; Transcatheter arterial chemoembolization and hepatic arterial infusion chemotherapy
Intervention type(s): Drug; Drug; Procedure
Intervention description(s): Atezolizumab 1200 mg IV d1, Q3W, combined with bevacizumab 15 mg/kg IV d1, Q3W treatment, treatment continued until disease progression, development of intolerable toxic reactions; Sintilimab 200 mg IV d1, Q3W, combined with bevacizumab 15 mg/kg IV d1, Q3W treatment, treatment continued until disease progression, development of intolerable toxic reactions; The chemoembolization process employed 30 mg/m2 of epirubicin and 2-10 mL of lipiodol. This was followed by FOLFOX-based HAIC, including 85 mg/m2 of oxaliplatin, 400 mg/m2 of leucovorin, and an initial bolus of 400 mg/m2 of 5-FU for 2 h, which was then followed by a sustained infusion of 1200 mg/m2 5-FU for 23 h.
Intervention MeSH terms: Bevacizumab; Atezolizumab
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        This retrospective real-world study enrolled patients treated in three medical centers in
        China, including Sun Yat-sen University Cancer Center, Affiliated Cancer Hospital &
        Institute of Guangzhou Medical University, and Sun Yat-Sen Memorial Hospital. These
        patients, diagnosed with treatment-naive uHCC, underwent simultaneous combination TACE-HAIC
        and A+B or S+B.
Study for Verification of Efficacy and Safety for Perampanel Monotherapy in Untreated Participants With Partial Onset Seizures (Including Secondarily Generalized Seizures (FREEDOM Study)
Condition: Partial Onset Seizures
MeSH terms: Seizures
Study type: Interventional
Phase: Phase 3

Summary: 
      This study is conducted to evaluate the seizure-free rate of the 26-week Maintenance Period
      in untreated participants with partial onset seizures (POS).
    


Intervention name(s): E2007
Intervention type(s): Drug
Intervention description(s): Oral tablet
Other intervention name(s): Perampanel; Fycompa; 2-(2-Oxo-1-phenyl-5-pyridin-2-yl-1,2-dihydropyridin-3-yl) benzonitrile hydrate (4:3)
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: perampanel
Optimization of the Anesthetic Regimen Using the SmartPilot® System and Influence on Different Outcome Parameters - a Pilot Study.
Condition: Postoperative Cognitive Disturbances
MeSH terms: Cognitive Dysfunction
Study type: Observational

Summary: 
      This study investigates whether general anesthesia using a Pharmacokinetic/Pharmacodynamic
      (PK/PD) -model-based index indicating the compound effect of different anesthetics leads to
      optimized outcome compared to manually controlled clinical anesthesia and computerized
      Electroencephalogram (EEG).
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Male/female patients scheduled for elective surgery (general/abdominal surgery;
        traumatological/orthopedic surgery, gynecology, urology) in general anesthesia at Charité -
        Universitaetsmedizin Berlin, Campus Mitte and Campus Virchow-Klinikum
Efficacy and Safety of Omalizumab in Patients With Severe Persistent Asthma
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to determine the effect of omalizumab, compared to placebo, on
      clinically significant asthma exacerbation rates in adolescents and adults with asthma.
    


Intervention name(s): Omalizumab
Intervention type(s): Drug
Intervention MeSH terms: Omalizumab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Anterior Cruciate Ligament (ACL) Reconstruction- Bioabsorbable Screw
Condition: Rupture of Anterior Cruciate Ligament
MeSH terms: Rupture
Study type: Observational

Summary: 
      To evaluate the knee functionality, screw integrity, graft integrity, cartilage effect, and
      bony ingrowth in patients treated with the CALAXO screw and MILAGRO screw two years after ACL
      reconstruction.
    

Detailed description: 
      This study will combine the use of survey response, MRI, and x-rays of the knees in Dr.
      Spindler's ACL reconstructed patients in order to examine long term healing of two types of
      bioabsorbable screw. We will use a 2-4 yr time point to look at patient reported symptoms of
      pain and swelling from the surveys and use the x-rays and MRIs to look at absorption of the
      screw, healing of the graft, and body reactions to the screw.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients 2-4 years post ACL reconstruction performed by Dr. Kurt Spindler, under age 35,
        injured in sport, unilateral primary ACL.
      
Keywords: bioabsorbable screw; acl reconstruction
Time Lag for Oocyte Denudation: A Better Choice for ICSI Outcome?!
Condition: Infertility, Female
MeSH terms: Infertility; Infertility, Female
Study type: Observational

Summary: 
      This study aiming to investigate if difference in the timing of cumulus removal post
      retrieval would have any critical impact on fertilization and embryonic development.
    

Detailed description: 
      Patients under 37 year old who were treated with controlled ovarian stimulation for ICSI were
      randomly divided into 2 groups; Group A: Oocytes were denudated immediately after oocyte
      retrieval , Group B: Oocytes were denudated 2 hours after retrieval and both groups were
      microinjected at 4 hours from ovum pickup. Microinjection was performed on all matured
      oocytes only and they were cultured to blastocyst stage.The rates of maturation,
      fertilization, good quality blastulation, chemical pregnancy and clinical pregnancy were
      analysed and compared between the two groups.
    

Intervention name(s): denudation time lag
Intervention type(s): Procedure
Intervention description(s): The time between ovum pickup and denudation of oocyte
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        couples who came seeking fertility through our IVF center
      
Keywords: denudation timing ICSI timing oocyte aging
Upper Airway Training for Treatment of Snoring
Condition: Snoring
MeSH terms: Snoring
Study type: Interventional

Summary: 
      The objective of this study is to reduce the incidence or intensity of snoring in a patient
      population of known simple snorers without sleep apnea using smartphone based application
      which allows participants to play voice controlled games using various articulations
      resulting in tongue base movements.
    


Intervention name(s): Smart phone game play; Control
Intervention type(s): Other; Other
Intervention description(s): Voice controlled smart phone game play 15 minutes daily and recording sounds of sleep environment 2 night per week for 12 weeks; Recording of sleep environment 2 nights per week for 12 weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Upper airway exercises; Smart phone application
Evaluation of a Handwashing Promotion Program in Chinese Elementary Schools
Condition: Communicable Diseases
MeSH terms: Communicable Diseases; Infections
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to determine the effects of a commercial hand washing promotion
      program on hygiene knowledge, attitudes, and practices, and on health outcomes such as
      reported infectious illnesses and school absences.
    

Detailed description: 
      Diarrheal and respiratory diseases cause 3.8 million deaths annually among children in the
      developing world. Reduced rates of these diseases have been measured during intensive,
      home-based handwashing interventions. We evaluated a school-based handwashing program for 1st
      grade students to determine whether a more scalable intervention could also reduce illness
      rates, and impact hygiene knowledge and attitudes.

      Thirty schools from each of 3 counties in Fujian Province, China, were randomized to one of
      the following groups: a) control; b) standard intervention, which included a handwashing
      program (1 hour of hygiene instruction and 1 soap sample kit per pupil); or c) expanded
      intervention, which included the handwashing program, soap for school sinks and 1 peer
      hygiene monitor per class. Teachers collected illness symptom information from students
      weekly and recorded student absences daily between January and April, 2005. Mean illness and
      absence rates were calculated for each school. Students were given a knowledge, attitudes,
      and practices questionnaire before the intervention and again 5 months later.
    

Intervention name(s): handwashing
Intervention type(s): Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: handwashing; communicable diseases; health education
The Nasal Airway in Chronic Obstructive Pulmonary Disease
Condition: Pulmonary Disease, Chronic Obstructive
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Study type: Observational

Summary: 
      The study is based on the theory of a "unified airway" that considers the nose and paranasal
      sinuses together with lower airways as one integrated unit. The upper and lower respiratory
      tracts function as an interdependent physiologic mechanism, and stimuli that trigger changes
      in one portion of the airway, can provoke similar changes throughout the airway. This is well
      documented in asthmatic patients but documented poorly in patients suffering from chronic
      obstructive lung disease (COPD).

      COPD is associated with sinonasal symptoms and decreased quality of life. Although nasal
      involvement has been found to directly affect the lower airway, sinonasal disease is
      under-diagnosed and under-treated in patients with COPD. This study is embedded in a larger
      project where the goal is to gain knowledge supporting the theory of a "unified airway" in
      patients with COPD.

      Here sinonasal, pulmonary and generic health related quality of life will be studied in a
      group of patients with COPD versus a control group. The severity of nasal airway obstruction
      will be linked to the the severity of pulmonary airway obstruction. Assessment of
      pathological changes in the nose with nasal endoscopy, as well as performing a nasal
      cytological brushing for the identification of nasal inflammatory responses in the nose, will
      be conducted in both the control and study group.
    


Intervention name(s): Upper airway assessment, including nasal biopsy
Intervention type(s): Other
Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        patients diagnosed with chronic obstructive pulmonary disease (COPD) in St Olavs Hospital,
        Trondheim, Norway, and healthy participants matched in age and sex.
      
Biospecimen description: 
      Nasal airway epithelial cells will be collected by the use of a nasal brush, and stored in a
      biobank.
    
Keywords: Paranasal Sinus Diseases; Nasal Obstruction
Medium-term Bedrest Whey Protein (MEP)
Condition: Countermeasure Evaluation
Study type: Interventional

Summary: 
      The human being has shown that he can live and work in the space environment, but due to the
      lack of essential mechanical load on muscle and bone, the fluid-shift as well as alterations
      in the acid-base balance (mainly on account of nutritional factors), the exposure to
      microgravity results in a gradual degradation of muscle, bone and cartilage, deconditioning
      of the cardiovascular system and metabolic changes. Countermeasures to prevent all the
      deconditioning of the physiological systems are not yet fully effective and require further
      investigation.

      A commonly utilized model of simulating the physiological effects of microgravity on the
      human organism on ground is the 6° head-down-tilt bed rest. In the present study the model
      has been used to study potential countermeasures to spaceflight-associated deconditioning.

      One of the most constrictive changes appearing during space flight as well as during bed
      rest, are disuse-induced muscle losses. These are associated with a decrease in muscle
      protein synthesis, rather then an increase in muscle protein breakdown. Besides an effective
      training countermeasure, nutritional countermeasures gain respect in this context:
      supplementing conventional diets with whey protein or essential amino acids has been shown to
      increase muscle protein synthesis. Due to these anabolic properties whey protein seems
      promising to counteract disuse-induced muscle wasting.

      Drawbacks of a high protein intake are calciuric effects, ascribed to the proton-release when
      metabolizing sulfur-containing amino acids. The so called 'low grade metabolic acidosis' has
      also shown to activate osteoclastic bone resorption and muscle protein degradation.
      Therefore, to maximize the anabolic potential of a whey protein supplementation, the
      acidogenic properties need to be compensated. As previous works suggest, a shift of acid base
      balance into the acid direction and the resulting changes in bone and protein turnover may be
      hindered by supplementing alkaline mineral salts.

      In this regard, a mid-term bed rest study was performed in order to investigate the effect of
      a combined whey protein (0.6 g/kg body weight/day) and potassium bicarbonate (90 mmol/day)
      supplementation as a potential countermeasure to multiple physiological and metabolic
      alterations on the human body resulting from real and simulated microgravity.
    


Intervention name(s): Whey Protein + Potassium bicarbonate; Control
Intervention type(s): Dietary Supplement; Other
Intervention description(s): 0.6 mmol WP/kg body weight + 90 mmol KHCO3 during bed rest; Bed rest without dietary supplement
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Metabolic Response of Slow Released Carbohydrates in Diabetes Mellitus
Condition: Type 2 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The study was conducted

        1. to investigate the superiority of isomaltulose in reduction of postprandial
           hyperglycemia

        2. to describe the kinetics of glucose absorption after a load of isomaltulose

        3. to demonstrate the safety of a single load of isomaltulose compared to sucrose in type 2
           diabetic patients.
    

Detailed description: 
      Epidemiological studies have shown that postprandial hyperglycemia is associated with
      atherosclerotic diseases. Therefore, therapeutic strategies to reduce postprandial
      hyperglycemia are desirable. An effective way to improve postprandial glucose level is the
      use of carbohydrates with low glycemic index. Isomaltulose is a reducing disaccharide
      occurring naturally in honey and sugar cane juice, including products derived thereof. It is
      an isomer of sucrose and composed of glucose and fructose linked alpha-1,6 instead of
      alpha-1,2.

      Isomaltulose has been reported to be digested more slowly than sucrose. Due to this property,
      lower and slower increases in blood glucose responses are expected for isomaltulose than
      sucrose. Early studies have demonstrated attenuated glycemic and insulin responses after
      isomaltulose ingestion than after sucrose. This study was performed to describe the
      postprandial glucose metabolism more comprehensively after bolus administration of different
      doses of isomaltulose compared to sucrose in type 2 diabetic patients.
    

Intervention name(s): Isomaltulose
Intervention type(s): Dietary Supplement
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Keywords: Isomaltulose; Slow Released Carbohydrates; Postprandial Glucose Metabolism; Type 2 diabetes
Safety of Inhaled Insulin With Type 1 and Type 2 Diabetes
Condition: Diabetes, Type 1; Diabetes, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2; Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Phase 3

Summary: 
      Pulmonary Safety in Diabetics with T/I
    


Intervention name(s): Technosphere® Insulin Inhalation Powder; Usual Care
Intervention type(s): Drug; Drug
Intervention description(s): Inhalation, 15U/30U; Subjects will receive antidiabetes treatment at the discretion of their physicians
Intervention MeSH terms: Insulin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Effects of Testosterone in Women With Depression
Condition: Depression
MeSH terms: Depression; Depressive Disorder
Study type: Interventional

Summary: 
      The purpose of the study is to determine whether adding a low dose of testosterone to current
      antidepressant therapy improves depression and fatigue in women who remain depressed despite
      necessary adequate doses of anti-depressants. Testosterone will be given over an 8-week
      period.

      Testosterone is a hormone that occurs naturally in the body. In women it comes from the
      ovaries and adrenal glands and is found in amounts that are ten to twenty times lower than in
      men.

      In early research studies, testosterone has been shown to have some antidepressant effects in
      the following groups of subjects:

        -  Women with anorexia nervosa

        -  Women who have low testosterone levels because their pituitary glands do not work

        -  Men with Selective Serotonin Reuptake Inhibitor (SSRI)-resistant depression.

      However, testosterone administration in women with SSRI or Serotonin-norepinephrine reuptake
      inhibitor (SNRI) -resistant depression has not been studied.
    


Intervention name(s): Testosterone
Intervention type(s): Drug
Intervention description(s): Testosterone atch delivering 300mcg daily for 8-weeks
Intervention MeSH terms: Testosterone
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Depression; Major Depressive Disorder
Fexofenadine Study On Filipino Children for The Relief of Perennial And Intermittent Allergic Rhinitis
Condition: Rhinitis, Allergic, Perennial
MeSH terms: Rhinitis; Rhinitis, Allergic; Rhinitis, Allergic, Perennial
Study type: Interventional
Phase: Phase 4

Summary: 
      To determine the safety and efficacy of Fexofenadine (Telfast®) 30mg pediatric tablets on
      Filipino children aged 6 to 11 for the relief of symptoms associated with perennial and
      intermittent allergic rhinitis.
    


Intervention name(s): Fexofenadine
Intervention type(s): Drug
Intervention description(s): Fexofenadine: One 30 mg Tablet once daily for two weeks
Intervention MeSH terms: Fexofenadine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Shoulder Rotational Flexibility and Throwing Arm Injuries of Baseball Pitchers
Condition: Shoulder Injuries; Shoulder Flexibility; Rotational Resistance of Shoulder
MeSH terms: Wounds and Injuries; Shoulder Injuries; Arm Injuries
Study type: Observational

Summary: 
      The evaluation of any relationship between the rotational resistance of the shoulder and
      shoulder flexibility with throwing arm injuries in professional and college level pitchers.
    


Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Collegiate level baseball pitchers
      
Keywords: Shoulder; Injuries; Flexiblity; Rotational resistance
Comparing the Pharmacodynamics and Pharmacokinetics of Explorative Formulation of Insulin Degludec With Insulin Glargine in Subjects With Type 1 and Type 2 Diabetes
Condition: Diabetes; Diabetes Mellitus, Type 1; Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2; Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Phase 1

Summary: 
      This trial is conducted in Europe. The aim of this trial is to compare the pharmacodynamics
      (the effect of the investigated drug on the body) and pharmacokinetics (the exposure of the
      trial drug in the body) of insulin degludec (insulin 454), an explorative formulation, not
      similar to the proposed commercial formulation, with insulin glargine in subjects with type 1
      and type 2 diabetes.
    


Intervention name(s): insulin degludec; insulin glargine
Intervention type(s): Drug; Drug
Intervention description(s): Three single doses administrated subcutaneously (s.c., under the skin) on three separate dosing visits. Dose will vary when administered to subjects with type 1 and type 2 diabetes, respectively.; Three single doses administrated subcutaneously (s.c., under the skin) on three separate dosing visits. Dose will vary when administered to subjects with type 1 and type 2 diabetes, respectively.
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Insulin Glargine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment