bioihbjkbjnl/mcl2 huggingface dataset:
HSK16149 for Perioperative Analgesia in Orthopedic Surgery
Condition: Post-operative Pain
MeSH terms: Pain, Postoperative
Study type: Interventional
Phase: Phase 2

Summary: 
      This study will compare the effect and safety of HSK16149 with placebo on perioperative
      analgesia in orthopedic surgery, and explore the dosage of HSK16149 capsules for orthopedic
      analgesia during perioperative period.
    

Detailed description: 
      This study included patients who have orthopedic surgery under general anesthetic, with
      expected operation time ≤4h.

      Subjects were given 40mg or 60mg of HSK16149 or placebo orally the night before surgery, 2h
      before surgery, 4h and 16h after surgery, for a total of 4 times during the whole treatment
      period.

      Subjects will receive intravenous patient-controlled analgesia (PCA) morphine for pain in the
      immediate postoperative period. If PCA is insufficient, rescue analgesia of morphine may be
      given I.V. as determined by the investigator.

      After the treatment period, the subjects will be followed up.
    

Intervention name(s): HSK16149 capsule; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Subjects will be given 40mg or 60mg of HSK16149 orally.; Subjects will be given HSK16149 placebo orally.
Other intervention name(s): HSK16149; HSK16149 placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Small Circulating RNA as Molecular Markers of Lung Disease in Cystic Fibrosis
Condition: Cystic Fibrosis
MeSH terms: Cystic Fibrosis; Lung Diseases; Fibrosis
Study type: Interventional

Summary: 
      The aim of our study is to assess miRNAs expression profiles in the circuling blood of
      patients with cystic fibrosis and highlight "signatures" that could reflect the pulmonary
      status of patients
    

Detailed description: 
      The objective of this project is to study the circulating miRNA profiles in 40 patients with
      cystic fibrosis (5 samples which are acquired through a secondary use) and 40 healthy
      individuals to assess whether these biomolecules could be used as markers of the pulmonary
      disease in cystic fifbosis. Moreover by comparing miRNAs expression level between Cystic
      fibrosis (CF) patients with severe (n=20) or moderate (n=20) pulmonary impairment, we want to
      assess whether some of these miRNAs may be used as markers for the severity of CF pulmonary
      disease. The identification of sensitive and early markers, from a non-invasive sampling
      could enable more effective and early treatment of CF patients.
    

Intervention name(s): miRNAs isolation from blood samples of patients and control
Intervention type(s): Other
Intervention description(s): Blood sample collection in specific PAXGene tubes
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Patient with Cystic Fibrosis; Patient without Cystic fibrosis
The Iron and Muscle Study
Condition: CKD Stage 3; CKD Stage 4; Iron-deficiency
MeSH terms: Iron Deficiencies
Study type: Interventional
Phase: Phase 4

Summary: 
      This is a multi-center randomized controlled trial that will examine the efficacy of IV iron
      supplementation when compared to placebo, with and without exercise training, on changes in
      patient exercise capacity. The study aims to provide sufficient data to inform a power
      calculation for the definitive study to examine whether IV iron therapy in patients with CKD
      stages 3-4 (non-dialysis) can improve exercise capacity, muscle metabolism and physical
      function. Specifically, we propose to examine whether a strategy of IV iron therapy in
      patients with stages 3-4 CKD who are iron-deficient but NOT anaemic leads to improvements in
      exercise capacity.

      Very little is currently known about the effects of iron deficiency on cardiac or skeletal
      muscle metabolism in patients suffering from CKD. Nevertheless, it seems likely that iron
      deficiency will contribute to mitochondrial dysfunction and reduced energy production in
      cardiac or skeletal muscle of CKD patients, and importantly may contribute to the reduced
      exercise capacity, physical function and overwhelming fatigue commonly reported in this
      population. The results of this trial will provide data to ascertain whether intravenous iron
      therapy might be beneficial to exercise capacity, muscle metabolism, physical function, and
      fatigue and whether iron repletion enhances the effect of an exercise intervention.
    


Intervention name(s): Ferinject; Placebo: NaCl (sodium chloride 0.9%)
Intervention type(s): Drug; Other
Intervention description(s): Active study medication Medication name: Ferinject® Active ingredient: Ferric carboxymaltose Dosage form: 50 mg iron/ml solution for injection/infusion. Appearance: Dark brown, non-transparent aqueous solution Excipients: Sodium hydroxide, hydrochloric acid and water for injection Strength/Packaging: Each 2 ml vial contains 100 mg of iron as ferric carboxymaltose.
Each 10 ml vial contains 500 mg of iron as ferric carboxymaltose. Each 20 ml vial contains 1,000 mg of iron as ferric carboxymaltose. Manufacturer: Vifor Pharma UK Limited; Medication name: NaCl (sodium chloride 0.9%) Active ingredient: NaCl (sodium chloride 0.9%) Dosage form: 0.9% w/v NaCl as sterile solution in water for injection Excipients: Water Strength/Packaging: 100 ml container with 100 ml normal saline Manufacturer: As per local hospital supplier
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Cell Therapy for Craniofacial Bone Defects
Condition: Cleft Palate; Trauma
MeSH terms: Cleft Palate
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of this research is to determine if a patient's own bone marrow tissue can help
      regenerate bone in the area of the jaw where an implant will be placed. The name of the
      process is called Bone Repair Cell (BRC) Therapy. A sample of bone marrow tissue will be
      collected and sent to a laboratory where it will be processed to form more cells. These new
      cells will then be transplanted in the regenerative site. The researchers are testing to see
      if these cells (BRC) will help form bone. The research will also determine if the implant
      will be more stable in the area with new bone growth.
    

Detailed description: 
      Up to 20 (twenty) subjects who have alveolar defects secondary to clefts (n=10) or trauma
      (n=10), will be selected to participate in this study. Among the 20 patients, a total of up
      to 60 defect sites will be evaluated for bone regeneration following therapy, with each
      subject being evaluated in from one to four sites. Once enrolled, subjects from each of the
      two groups (cleft or trauma) will be randomly assigned to receive one of two possible
      treatments, traditional autogenous bone grafting or cell therapy (ixmyelocel-T)
    

Intervention name(s): Ixmyelocel-T; Autogenous Bone Grafting
Intervention type(s): Biological; Procedure
Intervention description(s): Twelve days after the bone marrow aspiration, alveolar grafting will be performed. Under local anesthesia, and possibly conscious intravenous sedation (depending on patient desire for sedation due to anxiety), alveolar grafting will be performed with the cell therapy (Ixmyelocel-T); Alveolar grafting will be performed. Under local anesthesia, and possibly conscious intravenous sedation (depending on patient desire for sedation due to anxiety), alveolar grafting will be performed with an autogenous bone block harvested from an intraoral or extraoral site, according to standard of care.
Other intervention name(s): bone repair cells
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: dental implants
Postoperative Pain Therapy With Hydromorphone Using TCI-PCA
Condition: Postoperative Pain
MeSH terms: Pain, Postoperative
Study type: Interventional
Phase: Phase 4

Summary: 
      Treatment of postoperative pain with hydromorphone (a strong analgesic) using
      patient-controlled analgesia with target concentrations in blood compared to conventional
      patient-controlled analgesia after planed cardiac surgery
    


Intervention name(s): Hydromorphone
Intervention type(s): Drug
Intervention description(s): Hydromorphone is given by PCA or TCI-PCA. The TCI-PCA System steer the hydromorphone infusion pump to achieve plasma concentrations of hydromorphone in predefined increasing steps on patient request and in predefined decreasing steps on lack of patient request within predefined plasma concentration range, lock times and infusion speed.
Intervention MeSH terms: Hydromorphone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Therapy
Assessment of Novel Sound Changing Principles in Hearing Instruments to Determine Their Application - 2020_09
Condition: Hearing Loss
MeSH terms: Hearing Loss
Study type: Interventional

Summary: 
      Participants will perform two different listening tasks: (1) listening to, and repeating
      back, sentence lists presented in noise, and (2) Subjective rating of effort & performance
      following each condition. During this study, continuous, non-invasive physiological
      measurements (skin conductance, changes in pupil dilation) will be recorded from
      participants. Using this paradigm we will be assessing the effect of different hearing aid
      processing algorithms on listening effort. The study takes the form of a one factor
      (algorithm), within-subjects design.

      Each participant performs the Speech perception task with each algorithm (reference, noise
      reduction I, noise reduction II, noise reduction III), at two individualized signal-to-noise
      ratios (SRT90 and SRT50). Additionally subjective performance ratings in real-life will be
      collected.
    


Intervention name(s): Hearing Aid without NR enabled; Hearing Aid with NR(1); Hearing Aid with NR(2); Hearing Aid with NR(3)
Intervention type(s): Device; Device; Device; Device
Intervention description(s): Each participant will be fitted with noise reduction disabled. Disabled means that no sound processing algorithm that removes noise from the speech signal is active.; Each participant will be fitted with the noise reduction program on the same hearing aid. The principle of the noise reduction algorithm is to remove noise from a speech signal with the aim of improving the speech intelligibility and comfort.; Each participant will be fitted with a second noise reduction program on the same hearing aid. The parameterization of this NR algorithm differs from that in NR(1).; Each participant will be fitted with a third noise reduction program on the same hearing aid. The parameterization of this NR algorithm differs from that in NR(1) and NR(2).
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Treatment
PMS Study of Amlodipine/Valsartan for the Treatment of Hypertension
Condition: Essential Hypertension
MeSH terms: Hypertension; Essential Hypertension
Study type: Interventional
Phase: Phase 4

Summary: 
      The antihypertensive effect of Amlodipine/Valsartan combination has been evaluated in
      worldwide populations including Asian patients. The study primarily aims to evaluate the
      effectiveness of Amlodipine/Valsartan combination in patients with essential hypertension in
      Taiwan using a prospective, open-label, non-randomized approach.

      The study also wants to investigate the safety of Amlodipine/Valsartan combination during the
      6-week treatment period.
    


Intervention name(s): Amlodipine/Valsartan
Intervention type(s): Drug
Intervention description(s): Amlodipine/Valsartan: 5 mg/80 mg
Other intervention name(s): Am-Daiwen®
Intervention MeSH terms: Amlodipine; Valsartan; Amlodipine, Valsartan Drug Combination
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Study of SHR-1209 in the Treatment of Hypercholesterolemia and Hyperlipidemia Ⅲ Stage
Condition: Primary Hypercholesterolemia; Mixed Hyperlipemia
MeSH terms: Hyperlipoproteinemia Type V; Hypercholesterolemia; Hyperlipidemias
Study type: Interventional
Phase: Phase 3

Summary: 
      The study is ongoing to evaluate the efficacy and safety of SHR-1209 in patients with
      hypercholesterolemia and hyperlipemia.
    


Intervention name(s): SHR-1209; SHR-1209 Placebo
Intervention type(s): Drug; Drug
Intervention description(s): SHR-1209; SHR-1209 Placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: SHR-1209 monotherapy
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
A Phase Ib Study of the Recombinant Mycobacterium Tuberculosis Vaccine Freeze-dried (AEC/BC02)
Condition: Tuberculosis
MeSH terms: Tuberculosis
Study type: Interventional
Phase: Phase 1

Summary: 
      Single-center, single-dose, placebo-controlled, open-label trials were used to evaluate the
      safety and immunogenicity of low-dose adjuvants and low-dose vaccines in the upper arm
      deltoid muscle intramuscularly in the double negative population. Thirty (PPD-QFT-) healthy
      adult subjects aged 18-45 were selected and divided into placebo group, low-dose adjuvant
      group, and low-dose vaccine group. During the test, each subject must not change groups and
      inoculate drugs. Every two weeks (0-2-4-6-8-10 weeks), alternately inject a dose of placebo
      or left and right upper arm deltoid muscles. Low-dose adjuvant or low-dose vaccine, a total
      of 6 doses.
    

Detailed description: 
      Single-center, single-dose, placebo-controlled, open-label trials were used to evaluate the
      safety and immunogenicity of low-dose adjuvants and low-dose vaccines in the upper arm
      deltoid muscle intramuscularly in the double negative population. Thirty (PPD-QFT-) healthy
      adult subjects aged 18-45 were selected and divided into placebo group, low-dose adjuvant
      group, and low-dose vaccine group. During the test, each subject must not change groups and
      inoculate drugs. Every two weeks (0-2-4-6-8-10 weeks), alternately inject a dose of placebo
      or left and right upper arm deltoid muscles. Low-dose adjuvant or low-dose vaccine, a total
      of 6 doses.

      Collected adverse events within 14 days after each dose of vaccination, non-recruited adverse
      events within 30 days after the first dose of vaccination, subjects will receive 6 months
      follow-up after the last dose of vaccination, and study throughout Serious adverse events
      were recorded during the period. Immunogenicity will be assessed before the first dose, 24
      hours after the third dose, before the fourth dose, 24 hours after the sixth dose, 1 month,
      and 6 months.
    

Intervention name(s): Low-dose freeze-dried recombinant tuberculosis vaccine (AEC / BC02); Low-dose adjuvant for freeze-dried recombinant tuberculosis vaccine (AEC / BC02); Lyophilized recombinant tuberculosis vaccine (AEC / BC02) placebo
Intervention type(s): Biological; Biological; Biological
Intervention description(s): Population I are coxal muscle injection of low dose vaccine.; Population I are coxal muscle injection of low dose adjuvant.; The placebo drug contains 20mg mannitol and 10 millimole(mM) phosphate buffer(PB).population I are coxal muscle injection of placebo.
Intervention MeSH terms: Vaccines
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Tuberculosis; Vaccine
A Comparison Study of Bypassing Agent Therapy With and Without Tranexamic Acid in Haemophilia A Patients With Inhibitor
Condition: Hereditary Factor VIII Deficiency Disease With Inhibitor
MeSH terms: Hemophilia A; Deficiency Diseases
Study type: Interventional
Phase: Phase 4

Summary: 
      Activated prothrombin complex concentrate (aPCC) and recombinant activated factor VII
      (rFVIIa) are the only two drugs that are available to treat bleeds in haemophilia A patients
      with high titer inhibitors. However, management of bleeds in these patients can be
      challenging due to variation in response and lack of standardized methods to monitor the
      effect. We hypothesized that significant increase in whole blood clot stability could be
      achieved when tranexamic acid was given concomitantly with bypassing-agents while thrombin
      generation remains unaffected. In this prospective crossover study the effect of aPCC and
      rFVIIa with and without TXA on clot stability and thrombin generation capacity (ETP) were
      studied, using thromboelastography (ROTEM) and thrombin generation assay (TGA), respectively.
      In addition, the risk of thrombosis and disseminated intravascular coagulation (DIC) was
      assessed.
    

Detailed description: 
      Patients receive the first day aPCC (75IU/kg) and aPCC in addition to TXA (20mg/kg orally)
      the second day. After a 14 days washout period they crosse over using rFVIIa (90 µg/kg)
      otherwise the same experimental setup. Blood sampling is performed at baseline, 15, 30, 60,
      120, 180 and 240 minutes post-treatment.
    

Intervention name(s): aPCC, aPCC + TXA; rFVIIa, rFVIIa + TXA
Intervention type(s): Drug; Drug
Intervention description(s): Feiba 75 IU/kg i.v Feiba 75 IU/kg i.v +Cyklokapron 20 mg/kg p.o; NovoSeven 90 µg/kg i.v NovoSeven 90 µg/kg i.v + Cyklokapron 20 mg/kg
Other intervention name(s): Feiba i.v; Feiba i.v + Cyklokapron; NovoSeven 90 µg/kg i.v; NovoSeven 90 µg/kg i.v + Cyklokapron 20 mg/kg
Intervention MeSH terms: Tranexamic Acid; Anti-inhibitor coagulant complex
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Improving Sleep Quality in Heart Failure
Condition: Sleep Disturbance; Heart Failure
MeSH terms: Dyssomnias; Parasomnias; Heart Failure
Study type: Interventional
Phase: Phase 4

Summary: 
      Poor sleep quality is common in patients with heart failure. The limited available evidence
      intimates that improving sleep quality in patients with heart failure may improve morbidity
      and quality of life in this patient population. However, there is a paucity of evidence
      assessing the use of effective pharmacologic therapies in heart failure. The
      nonbenzodiazepine, GABA receptor agonist, zolpidem, has been found to have considerable
      benefits over traditional benzodiazepines as a soporific medication. The investigators
      hypothesize that zolpidem will safely improve sleep quality in patients with heart failure.
    


Intervention name(s): Zolpidem Tartrate; Placebo oral capsule
Intervention type(s): Drug; Drug
Intervention description(s): Zolpidem tartrate 5 mg capsule one per night taken for 7 nights; Placebo capsule one per night taken for 7 nights
Intervention MeSH terms: Zolpidem
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Single-site, randomized, parallel, placebo controlled, double blind study
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Effectiveness of Narrative Exposure Therapy Among Refugee Children and Adolescents
Condition: Narrative Exposure Therapy; Treatment as Usual
Study type: Interventional

Summary: 
      This study aims to understand how war trauma affects children's and adolescents' memory
      functions and mental health, and whether Narrative Exposure Therapy is effective in enhancing
      optimal memory functions and alleviating mental health problems. The study analyzes the
      mental health and cognitive and emotional healing mechanisms of therapeutic intervention
      among war-affected children and adolescents.
    


Intervention name(s): Narrative Exposure Therapy; Treatment as Usual
Intervention type(s): Behavioral; Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Spinal Cord Stimulation and Functional MRI
Condition: Complex Regional Pain Syndrome (CRPS); Neuropathic Leg Pain
MeSH terms: Complex Regional Pain Syndromes; Reflex Sympathetic Dystrophy
Study type: Observational

Summary: 
      The overall objective of this study is to assess patterns of fMRI cortical activation with
      spinal cord stimulation (SCS) in patients with neuropathic leg pain and therefore define
      cortical correlates, as well as to investigate cortical representations of pain and pain
      relief and the interactions therein, in the setting of neuropathic leg pain and SCS.
    

Detailed description: 
      The main objective is to define, using functional magnetic resonance imaging, the effects of
      spinal cord stimulation (SCS) on cortical and subcortical BOLD effects in patients with
      neuropathic leg pain. Our hypothesis is that SCS will demonstrate a consistent pattern of
      BOLD activation that will correlate with symptomatic improvement.
    

Observational model: Other
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients with implanted spinal cord stimulators
Efficacy, Safety, and Pharmacokinetic Profile of Etokimab (ANB020) in Adult Participants With Moderate-to-Severe Atopic Dermatitis
Condition: Atopic Dermatitis
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema
Study type: Interventional
Phase: Phase 2

Summary: 
      This study is designed to evaluate the efficacy, safety, and pharmacokinetic (PK) profiles of
      multiple doses of etokimab in adult participants with atopic dermatitis (AD).
    


Intervention name(s): Etokimab; Placebo
Intervention type(s): Biological; Drug
Intervention description(s): Humanized monoclonal antibody, administered by subcutaneous injection; Administered by subcutaneous injection
Other intervention name(s): ANB020
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: ANB020; etokimab; eczema; moderate to severe