bioihbjkbjnl/mcl2 huggingface dataset:
Thrombus Aspiration in Acute ST-elevation Myocardial Infarction
Condition: Acute ST-elevation Myocardial Infarction
MeSH terms: Myocardial Infarction; ST Elevation Myocardial Infarction; Infarction
Study type: Observational

Summary: 
      Thirty patients with acute ST-elevation myocardial infarction treated with primary PCI and
      aspiration of thrombus material from the infarct related coronary artery will be included.
      Both cellular and non cellular content of the thrombus will be examined with morphological
      and immunohistochemical methods and related to time from onset of symptoms to PCI, as well as
      to the degree of myocardial necrosis. Furthermore, mRNA expression of selected signal
      molecules will be performed. In addition, peripheral venous blood samples will be drawn and
      analyzed for signalling molecules and corresponding mRNA expression in circulating
      leukocytes.
    

Detailed description: 
      Observational, cross-sectional study on 30 patients with STEMI treated with thrombectomy and
      PCI with stent implantation. Composition and characteristics of the coronary thrombi with
      respect to cell types, genetic expression and presence of specific markers of inflammation,
      platelet activity, endothelial activation, coagulation and fibrinolysis will be investigated
      in relation to the levels of these markers in the general circulation, and specifically
      related to the time axis from symptom to PCI, as well as to the degree of myocardial
      necrosis.

      Intracoronary thrombus will be retrieved by standard aspiration catheter, washed with saline
      and stored on formalin as advised by the Department of pathology, OUS Ullevål. A specific
      protocol for morphological and immunohistochemical methods is prepared and has been shown
      suitable in a pilot study on 5 patients. Assessment of coronary TIMI flow and peripheral
      blush grade after thrombus aspiration and PCI will be done. At the same time, peripheral
      venous blood will be drawn, processed and stored at -80˚C for later analyses. Demographic
      variables will be recorded.
    

Observational model: Case-Only
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Patients with acute St-elevation myocardial infarction
      
Biospecimen description: 
      thrombus material and blood
    
Keywords: acute myocardial infarction,; thrombus aspiration
Deep Brain Stimulation (DBS) for Early Stage Parkinson's Disease (PD)
Condition: Parkinson's Disease
MeSH terms: Parkinson Disease
Study type: Interventional

Summary: 
      Bilateral subthalamic nucleus deep brain stimulation (B-STN DBS) is one of the most effective
      surgical treatments for PD patients suffering from levodopa-induced motor complications. The
      relatively low incidence of permanent adverse effects and the potential for neuroprotection
      and alteration of the natural course of PD suggest a highly favorable benefit-to-risk ratio
      of this procedure. Since neuroprotection is best applied early in the disease course when
      there are more surviving neurons, we believe that further investigation of this procedure is
      warranted. The proposed pilot study will provide the necessary data to substantiate the
      safety and tolerability of the procedure as well as provide data for the design of a
      full-scale, multicenter trial to investigate the hypothesis that B-STN DBS is a safe and
      effective treatment to slow the progression of PD.
    

Detailed description: 
      This pilot trial is designed specifically to collect the preliminary safety and tolerability
      data necessary to conduct a future phase III clinical trial to investigate the hypothesis
      that deep brain stimulation of the subthalamic nucleus in subjects with early Parkinson's
      will slow the progression of the disease.

      The study design is a prospective, randomized, blinded, single-center trial comparing the
      safety and tolerability of B-STN DBS + Optimal Drug Therapy (ODT) vs. (ODT) alone (control,
      standard of care) in 30 subjects (15 per group) with early PD (Hoehn and Yahr stage II when
      off medication).
    

Intervention name(s): B-STN DBS; Optimal drug therapy
Intervention type(s): Device; Drug
Intervention description(s): Deep brain stimulation (DBS) of both the right and left sub-thalamic nucleus (STN) is an FDA approved treatment for advanced PD. In mid- and advanced stage Parkinson's disease, using DBS in this area of the brain lessens symptoms and allows patients to take less drug to control the disease. Dosage and frequency are not applicable to the DBS. Once the DBS is placed, unless deemed necessary, it will not be removed.; The drugs used on this study are not investigational. They are drugs for Parkinson's disease that are standard of care. The drug form, dosage, frequency and duration will vary. Examples of drugs used include carbidopa/levodopa, pramipexole, ropinirole, and selegiline.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Other
Keywords: Early Stage Parkinson's Disease; Parkinson's Disease; Deep Brain Stimulation; PD; DBS
Vitamin D for the Treatment of Women With Polycystic Ovary Syndrome (PCOS)
Condition: Polycystic Ovary Syndrome
MeSH terms: Polycystic Ovary Syndrome; Syndrome
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of this study is to determine if vitamin D will improve insulin resistance,
      inflammation, and overall well-being in women with PCOS.
    

Detailed description: 
      As many cells throughout the body possess the vitamin D receptor, adequate vitamin D levels
      may be essential for multiple physiologic functions. In recent years, vitamin D insufficiency
      has been linked to insulin resistance, inflammation, poor psychological health, obesity, type
      2 diabetes, and cardiovascular disease - these are also commonly found in women with
      Polycystic Ovary syndrome (PCOS). We believe that vitamin D insufficiency contributes to
      insulin resistance, inflammation, and psychological distress in women with PCOS. These
      adverse effects may ultimately increase the risk for serious long-term complications in PCOS,
      including type 2 diabetes and cardiovascular disease. The key objectives of this research
      study are to determine the effects of vitamin D supplementation on insulin resistance,
      inflammation, mood and overall well-being in women with PCOS.

      The protocol has been modified by adding the following specific aim: To compare vascular
      function in healthy age and BMI similar matched women to PCOS women pre-treatment. Our
      hypothesis is that PCOS women will have greater attenuations in retinal vascular reactivity
      compared to healthy control women, demonstrating poorer endothelial function. We are
      currently recruiting healthy women who are age and BMI similar to the PCOS women and measure
      their retinal vascular reactivity for comparisons to the PCOS women's pre-treatment vascular
      reactivity. These healthy women will only have a baseline visit in which retinal vascular
      reactivity will be measured. They will not be enrolled in the placebo or Vitamin D
      randomization process as described above.
    

Intervention name(s): Vitamin D; Placebo
Intervention type(s): Dietary Supplement; Drug
Intervention description(s): Vitamin D 300 mcg by mouth once daily for 12 weeks; Placebo by mouth once daily for 12 weeks
Intervention MeSH terms: Vitamin D
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Polycystic Ovary Syndrome; Vitamin D; Insulin resistance; Inflammation
Safety, Attenuation and Immunogenicity of GAP3KO Administered Via A Stephensi Mosquitoes
Condition: Malaria
MeSH terms: Malaria
Study type: Interventional
Phase: Phase 1

Summary: 
      Study designed to evaluate safety and tolerability of a genetically attenuated P. falciparum
      (GAP3KO) that arrests early in the liver stage of the parasite life cycle. Study will also
      confirm the attenuation of the GAP3KO parasites using peripheral blood smears. Secondary
      objectives are to evaluate the humoral immune responses to GAP3KO.
    

Detailed description: 
      This single arm, open-label, phase 1 safety study is designed to evaluate the safety and
      tolerability of a genetically attenuated P. falciparum (GAP3KO) that arrests early in the
      liver stage of the parasite life cycle. The study will also confirm the attenuation of the
      GAP3KO parasites using peripheral blood smears. The secondary objectives of the study are to
      evaluate the humoral immune responses to GAP3KO.

      A total of 10 healthy, malaria-naïve adult subjects will be enrolled to receive GAP3KO via
      the bite of 150-200 GAP3K0-infected A. stephensi mosquitoes under controlled conditions.
      Subjects will be evaluated for safety, reactogenicity, and signs and symptoms of malaria to
      confirm attenuation for 28 days, including monitoring in a hotel setting 8-18 days post GAP
      3KO administration.
    

Intervention name(s): GAP3KO
Intervention type(s): Biological
Intervention description(s): GAP3KO administered via the bite of 150-200 GAP3KO-infected A. stephensi mosquitoes under controlled conditions.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Histones and Free-plasma DNA After Cardiac Arrest
Condition: Heart Arrest; Hypothermia; Post Cardiac Arrest Syndrome
MeSH terms: Post-Cardiac Arrest Syndrome; Heart Arrest; Hypothermia
Study type: Observational

Summary: 
      To evaluate the significance of free-plasma deoxyribonucleic acid (DNA) and plasma histones
      in cardiac arrest patients.
    


Intervention name(s): cardiac arrest
Intervention type(s): Other
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Cardiac arrest patients with a presumed cardiac origin, treated with targeted temperature
        management for 24 hours.

        For comparison; 20 healthy individuals were used.
Effect of BMS-986165 on the Blood Levels of Metformin
Condition: Healthy Participants
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to investigate the effects of BMS-986165 on the drug levels of
      metformin in healthy participants.
    


Intervention name(s): BMS-986165; Metformin
Intervention type(s): Drug; Drug
Intervention description(s): Specified dose on specified days; Specified dose on specified days
Other intervention name(s): Deucravacitinib
Intervention MeSH terms: Metformin; Deucravacitinib
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Drug interaction; Metformin; Pharmacodynamics; Pharmacokinetics
Effect of Tourniquet Application on Postoperative Functional Outcome Following Total Knee Arthroplasty
Condition: Osteoarthritis
MeSH terms: Osteoarthritis
Study type: Observational [Patient Registry]

Summary: 
      A pneumatic tourniquet is often used during total knee arthroplasty. However, its effect on
      postoperative outcomes as soft tissue damage resulting in delayed recovery remains unclear.
      The purpose of the present study was to compare tourniquet use versus non-tourniquet use
      during total knee arthroplasty for short-term functional recovery.
    

Detailed description: 
      In a prospective cohort design, consecutive series of patients who underwent primary
      unilateral total knee arthroplasty (TKA) in the Bergman Clinic, the Netherlands were
      investigated. Patients scheduled for primary TKA due to osteoarthritis, age between 50 and 75
      years and with Dutch language proficiency were eligible for inclusion. Exclusion criteria
      were inflammatory arthritis, severe cardiac complaints, severe pulmonary disorders, Body Mass
      Index (BMI) >35, severe coagulation disorders or hospitalization in the previous two months
      before surgery. Each patient included in the study signed informed consent. The research
      protocol was approved by the Regional Ethics Committee VCMO in Nieuwegein, the Netherlands,
      registration number W13.022.
    

Intervention name(s): Tourniquet application during surgery
Intervention type(s): Procedure
Intervention description(s): Both groups received usual care according to the orthopedic surgeons surgical preferences. One group received no tourniquet during surgery (non-tourniquet group) and the other group received a pneumatic tourniquet during surgery (tourniquet-group).
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        In a prospective cohort design, consecutive series of patients who underwent primary
        unilateral total knee arthroplasty in the Bergman Clinic Naarden, the Netherlands were
        investigated.
      
Keywords: Tourniquet; Postoperative outcome; Total knee arthroplasty
Efficacy and Safety of Increased Dose of TA-650 (Infliximab) in Patients With Crohn's Disease (CD)
Condition: Crohn's Disease
MeSH terms: Crohn Disease
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to assess the efficacy, safety and pharmacokinetics after
      administration of 10mg/kg TA-650 every 8 weeks to patients with Crohn's disease showing an
      insufficient response to previous treatment with 5 mg/kg of REMICADE every 8 weeks.
    


Intervention name(s): TA-650
Intervention type(s): Drug
Intervention description(s): (1) Screening Period: 5 mg/kg of TA-650 will be intravenously infused over a period of more than 2 hours at week 0. If patients do not meet the Eligibility Criteria at week 8, they will be administered 5 mg/kg of TA-650 at week 8. (2) Increased Dose Period: 10 mg/kg of TA-650 will be intravenously infused over a period of more than 2 hours every 8 weeks for 32 weeks.
Other intervention name(s): Infliximab
Intervention MeSH terms: Infliximab
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Infliximab; REMICADE; Crohn's disease
PG2 Phase I/II Clinical Study Intravenously Administered in Patients With Advanced Malignancy
Condition: Neoplasm Metastasis; Neoplasm Recurrence
MeSH terms: Neoplasms; Neoplasm Metastasis; Recurrence
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The objectives of this Phase I/II study are:

        1. To find out the maximum tolerated dose (MTD) of PG2 in patients with advanced malignancy
           receiving chemotherapy and to define a "Study Dose" for Phase II.

        2. To evaluate the hematopoietic and immunological responses after administering of PG2.
           Primarily to study the biological response of PG2, defined as WBC count in this study,
           and secondarily to study the immunological factors, IL-2, IL-6, TGF-beta, and G-CSF.
    

Detailed description: 
      This study is the first step for PG2 clinical development in Taiwan in order to further
      establish its safety and efficacy profile and to build the basis for larger trials.
    

Intervention name(s): PG2
Intervention type(s): Drug
Intervention description(s): Injectable
Allocation: Non-Randomized
Intervention model: Factorial Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: myelosuppression; chemotherapy; Astragalus membranaceus; hematopoietic response
Positron Emission Tomography - Computed Tomography (PET-CT) Scan as a Diagnostic Method in Unknown Primary Tumors
Condition: Unknown Primary Tumor
MeSH terms: Neoplasms, Unknown Primary
Study type: Observational

Summary: 
      Is PET-CT scan better than PET or CT alone in diagnosing primary tumours in patients with
      unknown primary tumors? Can information obtained with PET-CT replace other clinical and
      radiological investigations? Is PET/CT cost-effective?
    

Detailed description: 
      Patients who fulfill the international definition of unknown primary tumors can be included,
      except:

        -  Young men (<55 years) with growing mid-line tumors where a germ cell tumor could be
           expected will not be included.

        -  Patients with lymph-node metastases with squamous cell carcinoma in the head and neck
           region will not be included.

        -  Women with adenocarcinoma in lymph nodes in the axilla will not be included.
    

Intervention name(s): PET-CT
Intervention type(s): Procedure
Intervention description(s): no drugs included
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients with unknown tumors
      
Keywords: Unknown primary tumor; PET-CT
Ultrasound-guided Adductor Canal Block for Total Knee Replacement
Condition: Complications; Arthroplasty; Knee Injuries
MeSH terms: Knee Injuries
Study type: Interventional
Phase: Phase 4

Summary: 
      Total knee arthroplasty is associated with intense early postoperative pain. Fast track
      recovery programs including early therapy protocols and early hospital discharge are being
      implemented at various hospitals. The postoperative analgesic pain regimen should enhance
      functional recovery in addition to providing efficient analgesia with minimal side effects.
      Adductor canal blockade is commonly used to provide postoperative analgesia for total knee
      arthroplasty (TKA) surgery. The investigators hypothesize that an ultrasound guided adductor
      canal block will lower narcotic consumption and improved overall satisfaction compared to
      ultrasound guided sham block with normal saline (placebo) for patients undergoing minimally
      invasive TKA surgery.
    

Detailed description: 
      The investigators hypothesize that an ultrasound guided adductor canal block will lower
      narcotic consumption and improved overall satisfaction compared to ultrasound guided sham
      block with normal saline (placebo) for patients undergoing minimally invasive TKA surgery.
    

Intervention name(s): Bupivacaine; Preservative free normal saline
Intervention type(s): Drug; Drug
Intervention description(s): 10 ml of 0.25% bupivacaine; 10 ml of preservative free normal saline
Other intervention name(s): Sensorcaine; 0.9% sodium chloride
Intervention MeSH terms: Bupivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Efficacy and Safety of Naldemedine in Treating Opioid-induced Constipation
Condition: Opioid-induced Constipation
MeSH terms: Constipation; Opioid-Induced Constipation
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate the efficacy and safety of naldemedine in the
      treatment of opioid-induced constipation (OIC) in adults with non-malignant chronic pain who
      are not using laxatives.
    


Intervention name(s): Naldemedine; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Naldemedine 0.2 mg tablet taken orally once a day; Placebo tablet taken orally once a day
Other intervention name(s): S-297995; Symproic®
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Opioid-induced Constipation
Comparison of Walking Parameters Between Idiopathic Toe Walking and Independent Walking Diparetic Cerebral Palsy
Condition: Gait Disorders in Children; Cerebral Palsy Spastic Diplegia
MeSH terms: Paralysis; Cerebral Palsy
Study type: Observational

Summary: 
      The aim of the observational study is to compare static, kinematic and kinetic parameters
      with normal gait parameters in cases with Idiopathic toe walking (ITW) and Diparetic Cerebral
      Palsy (DCP) who have Gross Motor Function Classification System 1 level with the 3D Gait
      Analysis method, and to enable the early diagnosis of DCP and ITW. Male and female cases aged
      between 3-18 years will be included. This study will be carried out at Acıbadem Altunizade
      Hospital.
    

Detailed description: 
      It is an observational study. The aim of the observational study is to compare static,
      kinematic and kinetic parameters with normal gait parameters in cases with Idiopathic toe
      walking (ITW) and Diparetic Cerebral Palsy (DCP) who have Gross Motor Function Classification
      System 1 level with the 3D Gait Analysis method, and to enable the early diagnosis of DCP and
      ITW. Male and female cases aged between 3-18 years will be included. This study will be
      carried out at Acıbadem Altunizade Hospital. 51 cases will be included in our study. These
      cases will be divided into three groups. The first group will consist of patients diagnosed
      with idioaptic toe walking (n:17), the second group will be composed of diparetic cerebral
      palsy (n:15) with independent ambulation, and the third group will be the control group
      (n:19). First, the demographic information of the cases will be recorded. With 3D walking
      analysis, kinetic, kinematic and static data will be collected. The analysis of the obtained
      data will be done with Polygon Software (Vicon, Oxford, UK). Evaluated kinetic, kinematic and
      static parameters will be compared between three groups.

      Is the lower extremity compensation of children with diparetic cerebral palsy who can walk
      independently more than children with idiopathic toe walking?
    

Intervention name(s): 3D Gait Analysis
Intervention type(s): Other
Intervention description(s): 3D gait analysis was applied to children. Static, kinematic and kinetic walking parameters were evaluated
Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        A total of 51 cases, including 17 ITW(female:4;male:13), 15 DCP(female:5;male:10) and 19
        Control groups (female:6;male:13), were included.
      
Keywords: Toe walking; cerebral palsy; idiopathic toe walking; 3D gait analysis