bioihbjkbjnl/mcl2 huggingface dataset:
Effect of Physical Training Program on Health-related Quality of Life in Cirrhosis
Condition: Cirrhosis
MeSH terms: Liver Cirrhosis; Fibrosis
Study type: Interventional
Phase: Phase 2

Summary: 
      Physical training improves quality of life (QOL) in non-hepatic diseases. It is possible that
      the same effect happens in patients with cirrhosis and portal hypertension. Hepatic
      encephalopathy may also benefit from physical activity by increasing ammonia metabolism. The
      intention of this study is to assess if patients can improve their QOL and hepatic
      encephalopathy during a physical training program, and to address its safety.
    

Detailed description: 
      Patients with cirrhosis and portal hypertension experience a marked deterioration in
      health-related quality of life (QOL), as it has been shown with the use of questionnaires
      such as Short-Form-36 (SF-36) and Chronic Liver Disease Questionnaire (CLDQ). The
      deterioration in QOL is progressively accentuated as liver failure advances. There is a
      positive association between the level of physical activity and the sense of QOL, and
      physical training programs have proved to be useful in improving QOL in cardiovascular and
      pulmonary diseases, and in conditions affecting cognition. Thereby, it is hypothesized that a
      physical training program may improve QOL and hepatic encephalopathy in patients with
      cirrhosis and portal hypertension. Data supporting physical activity as a way to improve
      hepatic encephalopathy derives from experimental models showing that skeletal muscle is able
      to remove blood ammonia, presumably by inducing the enzyme glutamine synthetase. However, it
      is uncertain whether such a program is safe, or if it can lead to an increase in portal
      hypertension and progression of the disease.
    

Intervention name(s): Physical training; Diet intervention
Intervention type(s): Other; Other
Intervention description(s): A program of exercising under strict surveillance, with endurance and coordination maneuvers; Energy intake tailored to basal metabolism and level of physical activity. Protein and sodium intake will be adjusted to 1.2-1.5 g/kg/d, and 1.5-2 g/d of salt, respectively. The latter will be adjusted only in those patients presenting ascites and/or edema
Other intervention name(s): Exercise; Muscle ammonia metabolism; Nutritional therapy; Diet
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Acute Otitis Media: Adjuvant Therapy to Improve Outcome
Condition: Otitis Media
MeSH terms: Otitis; Otitis Media
Study type: Interventional
Phase: Phase 3

Summary: 
      Acute otitis media is one of the most common diseases of childhood and is one of the major
      causes of hearing loss in children. Despite the availability of effective antibiotic therapy
      for otitis media, treatment failures, persistent effusions, and recurrences are common. This
      Phase III outpatient study aims to test whether adjuvant therapy (an antihistamine or a
      corticosteroid), in addition to antibiotic therapy, improves the acute and long-term outcomes
      of patients with acute otitis media. This study is targeted to recruiting 200 infants (age
      less than one year); patient (and parent) participation is estimated to continue for one year
      after enrollment.
    


Intervention name(s): Antihistamine; Corticosteroid
Intervention type(s): Drug; Drug
Intervention MeSH terms: Histamine Antagonists; Histamine H1 Antagonists
Allocation: Randomized
Masking: Double
Primary purpose: Treatment
Keywords: Antibiotics; Adrenal Cortex Hormones; Histamine H1 Antagonists; Infant; Otitis Media
Dose-Finding and Human Abuse Potential Study Of HSK3486 Injection In Nondependent, Recreational Central Nervous System Depressant Users
Condition: General Anesthesia
Study type: Interventional
Phase: Phase 1

Summary: 
      Part 1: To determine the doses of IV HSK3486 and propofol for use in Part 2, the abuse
      potential part of the study.

      Part 2: To evaluate the abuse potential of HSK3486 compared with propofol when administered
      IV to healthy nondependent, recreational CNS depressant drug users.
    

Detailed description: 
      This single center study will consist of 2 parts. Part 1 will be an open-label, dose-finding
      study of HSK3486 and propofol conducted in up to 48 recreational users of CNS depressants to
      determine the appropriate doses to be used in Part 2 of the study. Part 2 will be a
      randomized, double-blind, placebo- and active-controlled 4-period, 4 way crossover, in
      approximately 42 healthy volunteers with prior recreational CNS depressant exposure. Both
      Part 1 and Part 2 of the study will consist of an outpatient Screening Visit, an in-clinic
      Treatment Phase, and Follow-up; Part 2 will also include a Qualification Phase.
    

Intervention name(s): HSK3486; Propofol; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): HSK3486 for induction of general anesthesia; Propofol for induction of general anesthesia; Intralipid
Intervention MeSH terms: Propofol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Observation on the Immune Persistence of People Aged 10-60 Years Old Immunized With Five Doses of Rabies Vaccine
Condition: Rabies; Antibody
MeSH terms: Rabies
Study type: Interventional
Phase: Phase 4

Summary: 
      Evaluation of immune persistence after rabies vaccination in 150 people.
    

Detailed description: 
      150 subjects aged 10-60 were recruited to inoculate the frozen human rabies vaccine (Vero
      cells) produced and marketed by Changchun Zhuoyi Biological Co., Ltd. in the whole process of
      0, 3, 7, 14 and 28 day immunization. The immunogenicity persistence and safety of the test
      vaccine were evaluated 14 days, 6 months and 12 months after the whole process of
      vaccination.
    

Intervention name(s): 5 doses program
Intervention type(s): Biological
Intervention description(s): Inoculate 5 doses of rabies vaccine, and collect blood at fixed time points to detect neutralizing antibody
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: rabies vaccine; antibody; persistence
Intraoperative Sublingual Sufentanil for Acute Pain in the Ambulatory Surgery Center
Condition: Pain; Pain, Acute; Anesthesia
MeSH terms: Acute Pain
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to determine if a single dose of sublingual sufentanil given
      15-30 minutes prior to wake up is efficacious at reducing recovery room time.
    

Detailed description: 
      This is a level I randomized prospective outcomes study comparing two groups of patients.
      Within 15-30 minutes of planned wake-up Group 1 will receive 30 mcg of sublingual sufentanil
      and group 2 will not receive sublingual sufentanil.
    

Intervention name(s): Sublingual Sufentanil
Intervention type(s): Drug
Intervention description(s): 15-30 minutes prior to planned emergence from anesthesia patients will either receive 30 mcg of sublingual sufentanil dispensed by the anesthesia provider.
Other intervention name(s): Dsuvia; Sufenta
Intervention MeSH terms: Sufentanil
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
A Multiple-Ascending Dose Study in Type 2 Diabetes Mellitus Patients
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      The study drug LY2393910 is being evaluated as a possible treatment for diabetes. The primary
      purpose of a patient's participation in this study is to help answer the following research
      question(s), and not to provide treatment for diabetes:

        -  The safety of LY2393910 and any side effects that might be associated with it following
           2 weeks of doses

        -  How long it takes the body to absorb and remove LY2393910 following dosing over 2 weeks

        -  How daily dosing of LY2393910 affects blood levels of sugar (glucose), insulin and other
           naturally occurring substances in your body

        -  How daily dosing of LY2393910 affects the cells that produce insulin

        -  Any differences in the above between LY2393910 taken as daily doses in the morning or in
           the evening
    


Intervention name(s): LY2393910; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): as capsules, administered orally once daily for two weeks; as capsules, administered orally once daily for two weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Tongxinluo Capsule in Ischemic Stroke Patients（TISS)
Condition: Ischemic Stroke
MeSH terms: Stroke; Ischemic Stroke; Cerebral Infarction; Ischemia
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to assess the effects in improving life self-care ability of
      stroke patients after taking Tongxinluo Capsule(within 72 hours after onset) versus Placebos
      for 90 days.
    

Detailed description: 
      The study is a randomized, double-blind, placebo controlled, multi-center trial. We aim to
      enroll a total of 1968 individuals(984 cases in each group) with acute ischemic stroke less
      than 72 hours after onset. Participants will be randomized into Tongxinluo capsule treatment
      group with the capsule administration of 4 granules tid. for 90 days, while the patients in
      the control group receive placebo capsule. NIH Stroke Score of the subjects is 4-22 at
      randomization. Evaluations of efficacy and safety will be taken at baseline, 7 days,
      discharge date and 90 days. Neuroimaging [magnetic resonance imaging (MRI) scans] will be
      obtained at baseline and 90 days after therapy. The primary efficacy endpoint is the
      proportion of Modified Rankin Scale (mRS) ≤1 at 90 days.
    

Intervention name(s): Tongxinluo capsule; placebo capsule
Intervention type(s): Drug; Drug
Intervention description(s): for 90 days; for 90 days
Other intervention name(s): Yiling Pharmaceutical，Z19980015; placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Ischemic Stroke; Tongxinluo capsule
Safety, Tolerability, Pharmacokinetics and Early Pharmacodynamics of Single Rising Oral Doses of BI 1021958 Tablets in Healthy Male Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      Safety, tolerability, pharmacokinetics and early pharmacodynamics of single rising oral doses
      of BI 1021958 tablets in healthy male volunteers (first-in-human trial)
    


Intervention name(s): BI 1021958; BI 1021958; Placebo to BI 1021958
Intervention type(s): Drug; Drug; Drug
Intervention description(s): tablet; drinking solution / tablet; SRD part: oral administration in fasted state, FE part: oral administration in fasted state and after standard high fat breakfast
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single
Primary purpose: Treatment
Randomized Controlled Trial of Higher-Volume Feedings in Preterm Neonates
Condition: Infant Premature
Study type: Interventional

Summary: 
      The primary hypothesis is that preterm infants who are less than or equal to 32 weeks
      gestation and weigh 1001-2500 grams at birth will have an increase in weight gain with a
      feeding goal of 180-200 ml/kg/day more than the commonly used feeding goal of 140-160
      ml/kg/day
    

Detailed description: 
      The proposed trial is designed to test the primary hypothesis that in preterm infants
      weighing 1001-2500 grams at birth and who are less than or equal to 32 weeks gestation,
      feeding goals of 180-200 ml/kg/day will increase weight gain (g/k/day) from time of
      enrollment to discharge home or 36 weeks post-menstrual age (PMA)(whichever comes first) more
      than the commonly used feeding goal volume of 140-160 ml/kg/day (usual feeding goal). This is
      a pilot study to determine the safety of increased volumes of feedings as opposed to
      fortification of feedings.
    

Intervention name(s): Higher Volume Feeding Goal
Intervention type(s): Other
Intervention description(s): feeding volume goal of 180-200 ml/kg/day
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Nutritional support
Metabolic Causes of Thrombosis in Type 2 Diabetes - Question 4
Condition: Type 2 Diabetes
MeSH terms: Thrombosis; Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Early Phase 1

Summary: 
      Hypoglycemia (low blood glucose level) occurs frequently in intensively treated patients with
      diabetes. Although hypoglycemia was thought to occur almost exclusively in T1DM, with the
      advent of improved metabolic control in T2DM, the incidence of hypoglycemia is rising in
      these patients. Therefore in this application, we will test the novel hypothesis that prior
      hypoglycemia will result in (cardiovascular complications) during subsequent hypoglycemia.
    

Detailed description: 
      This study will test the hypothesis that 1) hypoglycemia causes a prothrombotic state and
      defective endothelial function and 2) episodes of repeated hypoglycemia will result in
      greater impairments of endothelial function and an increased prothrombotic tendency.
      Preliminary data in healthy men demonstrates that hypoglycemia can dramatically increase
      PAI-1 levels and the PAI-1 to tPA ratio, thereby creating a prothrombotic state. Whether this
      also occurs in type 2 DM patients is unknown. Furthermore, the effects of hypoglycemia on
      endothelial function in T2DM are also unknown.
    

Intervention name(s): Hyperinsulinemic Hypoglycemic Clamp
Intervention type(s): Other
Intervention description(s): all participants received (2) hyperinsulinemic glucose clamp studies separated by 8 weeks
Intervention MeSH terms: Hypoglycemic Agents
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: Type 2 Diabetes; Endothelial Function; Fibrinolytic Balance; Hypoglycemia
Neoadjuvant Endostatin and Chemotherapy for Breast Cancer
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      This study was designed to determine the efficacy and safety of neoadjuvant docetaxel and
      epirubicin (DE) with or without human recombinant endostatin (endostar) for breast cancer
      patients. The hypothesis of this protocol is that a combined angiogenesis inhibiting therapy
      to chemotherapy could further enhance the cytotoxic activity in breast cancer.
    

Detailed description: 
      This is an open labelled, prospective, randomized, phase II clinical trial. A total of 60
      patients with core-biopsy confirmed breast cancer, stage ⅡA to ⅢC, and to be treated with
      neoadjuvant systemic therapy are eligible for entry into this study. Patients will be
      allocated randomly to two groups to receive either 3 cycles of neoadjuvant DE and endostar or
      3 cycles of neoadjuvant DE. All cases receive mammography, contrast-enhanced ultrasound
      (CEUS), magnetic resonance angiography (MRA), and positron emission tomography (PET) scanning
      pre- and post-neoadjuvant therapy, and then undergo surgical resection. The primary endpoint
      is clinical/pathological response. The secondary endpoint is (1) the safety and tolerability
      of the regimens, (2) the role of mammography, CEUS, MRA and PET for response evaluation, and
      (3) angiogenic profile and biological information involved in tumor response.
    

Intervention name(s): docetaxel and epirubicin; docetaxel and epirubicin plus endostatin
Intervention type(s): Drug; Drug
Intervention description(s): docetaxel 75mg/m2, IV (in the vein) on day 1 of each 21 day cycle; epirubicin 60 mg/m2, IV (in the vein) on day 1 of each 21 day cycle, totally 3 cycles; docetaxel 75mg/m2, IV (in the vein) on day 1 of each 21 day cycle; epirubicin 60 mg/m2, IV (in the vein) on day 1 of each 21 day cycle; endostatin 7.5mg/m2, IV (in the vein) on 1st to 14th days of each 21 day cycle; every 3 weeks, totally 3 cycles
Other intervention name(s): docetaxel, Sanofi-Aventis; epirubicin, Pfizer; recombinant human endostatin, Simcere Co. China
Intervention MeSH terms: Docetaxel; Epirubicin; Endostatins
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: breast cancer; neoadjuvant chemotherapy; docetaxel; epirubicin; recombinant human endostatin (endostar); chemotherapy; endostatin
Efficacy and Safety of OMS103HP in Patients Undergoing Autograft Anterior Cruciate Ligament (ACL) Reconstruction
Condition: Knee Injuries
MeSH terms: Knee Injuries
Study type: Interventional
Phase: Phase 3

Summary: 
      The anterior cruciate ligament (ACL) is an important stabilizer of the knee. Orthopedic
      surgeons replace the torn ligament during ACL reconstruction surgery. Surgical trauma
      initiates an acute inflammatory response, including swelling and pain, that leads to
      restricted joint motion and loss of function. OMS103HP was designed to deliver targeted
      therapeutic agents directly to the surgical site during the arthroscopic procedure to inhibit
      inflammation and pain before they can begin.

      The purpose of this study is to assess the effectiveness and safety of OMS103HP in improving
      knee function following ACL reconstruction using a hamstring autograft. Secondary benefits
      being evaluated include reduced postoperative pain, improvement in knee range of motion, and
      earlier return to work.
    


Intervention name(s): OMS103HP; Vehicle
Intervention type(s): Drug; Drug
Intervention description(s): Maximum of 39 liters of OMS103HP irrigation solution over a maximum of 2 hours; Maximum of 39 liters of vehicle irrigation solution over a maximum of 2 hours
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Anterior cruciate ligament reconstruction; ACL reconstruction
A Pilot Trial of a Developmental, Individual-Difference, Relationship-Bases (DIR)/Floortime for Children With Autistic Spectrum Disorders
Condition: Autistic Spectrum Disorders
MeSH terms: Autistic Disorder; Autism Spectrum Disorder; Child Development Disorders, Pervasive
Study type: Interventional

Summary: 
      Thirty two children age 2-6 years are recruited into the study and the randomization will be
      stratified for chronological age and symptom severity into 2 main groups, intervention and
      control. The intervention group will receive an additional target treatment of DIR/Floortime
      parent training intervention, while the control group will continue on their routine care for
      3 months.

      Hypothesis: Children in the intervention group show much improvement in climbing the
      developmental "ladder" and declining in the autistic behaviors.
    


Intervention name(s): DIR/Floortime; Routine care
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Developmental, Individual-Difference, Relationship-Bases (DIR) focus more on relationship, social skills, and meaningful, spontaneous use of language and communication and integrated understand of human development; Routine care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Food-Effect on PK and PD of Single Oral Dose of CJ-12420 in Healthy Male Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      -  Primary: To evaluate food effect on the pharmacokinetics (PK) of a single oral dose of
           CJ-12420 in healthy male subjects.

        -  Secondary

             -  To explore food effect on the pharmacodynamics (PD) of single oral dose of CJ-12420
                in healthy male subjects(PD/PK group)

             -  To evaluate the safety of single oral dose of CJ-12420 in healthy male subjects
                under fed or fasting condition.
    


Intervention name(s): CJ-12420 200mg
Intervention type(s): Drug
Intervention description(s): Period1: CJ-12420 200mg fed condition Period2: CJ-12420 200mg fasting condition
Period1: CJ-12420 200mg fasting condition Period2: CJ-12420 200mg fed condition
Other intervention name(s): CJ-12420
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Food-Effect; Pharmacokinetics; Pharmacodynamics
Wireless Assessment of Respiratory and Circulatory Distress in Chronic Obstructive Pulmonary Disease - an Observational Study
Condition: Chronic Obstructive Pulmonary Disease
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Study type: Observational

Summary: 
      For patients admitted to the medical ward, it is often difficult to predict if their clinical
      condition will deteriorate, however subtle changes in vital signs are usually present 8 to 24
      hours before a life-threatening event such as respiratory failure leading to ICU admission,
      or unanticipated cardiac arrest. Such adverse trends in clinical observations can be missed,
      misinterpreted or not appreciated as urgent. New continuous and wearable 24/7 clinical vital
      parameter monitoring systems offer a unique possibility to identify clinical deterioration
      before patients condition progress beyond the point-of-no-return, where adverse events are
      inevitable. The WARD-COPD project aims to determine the correlation between cardiopulmonary
      micro events and clinical adverse events during the first four days after hospital admission
      with acute exacerbation of Chronic Obstructive Pulmonary Disease (AECOPD).
    


Intervention name(s): Continuous monitoring system
Intervention type(s): Device
Intervention description(s): Patients recruited will be continuously monitored with Isansys Lifetouch patch, Isansys wireless blood pressure monitor, Nonin WristOx 3150, Empatica E4, and Radiometer TCM5 FLEX monitor.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        200 patients admitted to hospital with acute exacerbation of COPD will be included in the
        study upon arrival to the medical ward.
      
Biospecimen description: 
      Troponin, Arterial Blood Gas
    
Keywords: Continuous monitoring