bioihbjkbjnl/mcl2 huggingface dataset:
Long-term Outcome After Heparin and Edoxaban Versus Heparin Plus Vit K Antagonists for Acute DVT and PE
Condition: Post Thrombotic Syndrome; Deep Vein Thrombosis; Chronic Thromboembolic Pulmonary Hypertension
MeSH terms: Hypertension, Pulmonary; Thrombosis; Venous Thrombosis; Postthrombotic Syndrome; Postphlebitic Syndrome
Study type: Interventional

Summary: 
      Centers that participated in the HOKUSAI VTE trial will be invited to collect follow of
      previously enrolled patients at least 2 years after the index VTE.
    

Detailed description: 
      HOKUSAI VTE trial was a randomised double blind non inferiority trial that compared the
      efficacy and safety of heparin ) (enoxaparin or unfractionated heparin) followed by edoxaban
      with heparin (enoxaparin or unfractionated heparin) followed by warfarin (target INR 2-3) in
      patients with acute, symptomatic VTE.

      Centers that participated in the HOKUSAI VTE trial will be invited to collect follow of
      previously enrolled patients at least 2 years after the index VTE.

      patients with index DVT will be asked to complete the SF-36 and PembQoL questionnaire to
      assess the (venous disease-specific) quality of life.

      The Villalta score will be used to assess PTS. The objectively and subjectively obtained
      Villalta score- known as the patient reported Villalta -will be compared .

      Among patients with with an index PE, the QoL will be assessed bu the validated generic
      (SF-36) and DVT at index will be examined for PTS and will be asked to complete all
      questionnaire.
    

Intervention name(s): no intervention
Intervention type(s): Other
Intervention description(s): SF-36 questionnaire , PembQoL, Villalta score ,PembQoL
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Boost Study 31380 (mHealth)
Condition: Addiction
MeSH terms: Behavior, Addictive
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this research is to examine the potential for a new software-based behavioral
      support approach, for individuals with opioid use disorder, as an addition to usual care.
    

Detailed description: 
      The purpose of this study is to examine the potential for a novel computer-based approach to
      mitigate the symptoms of opioid use disorder as part of a comprehensive treatment program.
      The study is designed as a single-arm field-test of cognitive training for individuals under
      supervised medical treatment for opioid use disorder. A custom and proprietary smartphone
      application comprises the intervention available to enrolled subjects for interaction over
      the study period. Commercial mobile devices serve as information presentation and data
      recording instruments. Additional outcome measures incorporate subject-reported data.
    

Intervention name(s): MHealth
Intervention type(s): Device
Intervention description(s): Mobile application
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Neurocognitive Function After Regional and General Anesthesia (245_14 B)
Condition: Neurocognitive Function
Study type: Observational

Summary: 
      Postoperative cognitive dysfunction (POCD) is a disease with restricted cognitive memory
      function and intellectual skills, which occurs after surgery with and without anesthesia. The
      POCD strongly depends on patient's age and the surgical operation type. The anesthesia
      procedure plays a pivotal role as well and regarding the current knowledge it is still
      uncertain which technique matches the lowest risk. Elevated stress level accompanied with
      regional anesthesia procedures are accused to cause POCD in elderly patients. The
      investigators address the question weather regional or general anesthesia leads to a
      pronounced POCD in dependence of stress incidence.
    

Detailed description: 
      Postoperative cognitive dysfunction (POCD) is a disease with restricted cognitive memory
      function and intellectual skills, which occurs after surgery with and without anesthesia. The
      limiting cognitive ability leads to a lack of quality of life for a lot of patients. The POCD
      strongly depends on patient's age and the surgical operation type. In aged adults the
      incidence of POCD after one week following surgery is 25,8%. Risk factors for the development
      of a POCD is beside age less education and a reduced cognitive reserve. However, the
      anesthesia procedure plays a pivotal role as well and regarding the current knowledge it is
      still uncertain which technique matches the lowest risk. Elevated stress level accompanied
      with regional anesthesia procedures are accused to cause POCD in elderly patients. This fact
      leads to the question if a general anesthesia technique has a lower stress level and
      consequently leads to a reduced risk for a POCD development. Likewise the investigators
      address this hypothesis and analyze cognitive function following both anesthesia techniques
      separately in elderly patients.
    

Intervention name(s): Surgery; Cortisol Level Measurement; Neurocognitive Testing
Intervention type(s): Procedure; Procedure; Procedure
Intervention MeSH terms: Hydrocortisone
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients recruted at the University Hospital Erlangen prior surgery. Anesthesia procedure
        eigther in regional or general manner.
Combination Chemotherapy Plus Peripheral Stem Cell Transplantation in Treating Patients With Small Cell Lung Cancer
Condition: Lung Cancer
MeSH terms: Lung Neoplasms; Small Cell Lung Carcinoma
Study type: Interventional
Phase: Phase 2

Summary: 
      RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so
      they stop growing or die. Combining chemotherapy with peripheral stem cell transplantation
      may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells.

      PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy plus
      peripheral stem cell transplantation in treating patients who have small cell lung cancer.
    

Detailed description: 
      OBJECTIVES: I. Determine the feasibility of the administration of intensive chemotherapy with
      ifosfamide, carboplatin, and etoposide followed by peripheral blood stem cell support in
      patients with small cell lung cancer. II. Determine the rate and duration of response in
      these patients after this treatment. III. Determine the progression free and overall survival
      of these patients.

      OUTLINE: This is an open label, multicenter study. Patients receive 4 courses of intensive
      chemotherapy consisting of ifosfamide IV over 24 hours and carboplatin IV over 1 hour on day
      1 and etoposide IV over 1 hour on days 1 and 2. Filgrastim (G-CSF) is administered
      subcutaneously beginning on day 2 and continuing until blood cell counts recover. Courses
      repeat every 14 days. Peripheral blood stem cells (PBSC) are collected after course 1. PBSC
      are reinfused on day 3 of courses 2 and 3. Patients who experience a complete response
      receive prophylactic cerebral irradiation on day 71. Patients are followed every 2 months for
      5 years.

      PROJECTED ACCRUAL: A total of 36 patients will be accrued for this study within 18 months.
    

Intervention name(s): filgrastim; carboplatin; etoposide; ifosfamide; in vitro-treated peripheral blood stem cell transplantation
Intervention type(s): Biological; Drug; Drug; Drug; Procedure
Intervention MeSH terms: Carboplatin; Etoposide; Ifosfamide
Primary purpose: Treatment
Keywords: extensive stage small cell lung cancer
Long Term Metformin in Women With Polycystic Ovary Syndrome
Condition: Polycystic Ovary Syndrome
MeSH terms: Polycystic Ovary Syndrome; Syndrome
Study type: Observational

Summary: 
      The investigators analyzed collection data of 10 years for the efficacy of metformin on body
      mass, menstrual frequencies, metabolic and hormonal outcomes in women with polycystic ovary
      syndrome (PCOS) and BMI ≥ 25kg/m2.

      Each patient's age and height were recorded at baseline. In addition each patient weight,
      waist circumference, menstrual regularity, fasting glucose, glucose after 120 minute oral
      glucose tolerance test, luteinizing hormone, follicle stimulating hormone , free and direct
      testosterone, androstenedione, sex hormone binding globulin, dehydroepiandrosterone sulfate
      were identified at baseline and at the every follow up visit where available.
    


Observational model: Other
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        Collection data from endocrine outpatient clinic for 10 years of women with PCOS phenotype
        A, BMI≥ 25kg/m2, all receiving monotherapy with metformin 1000 mg twice a day.
The Effects of Low-level Laser Therapy in Extensor Tendon Injuries Between Zones 5-8
Condition: Tendon Injury - Hand
MeSH terms: Wounds and Injuries; Tendon Injuries
Study type: Interventional

Summary: 
      This study examines the rehabilitation results when low-level laser therapy is applied in
      zone 5-8 extensor tendon injuries. Rehabilitation results will be evaluated with both
      objective measurements and patient reported outcome measures. The study was planned as a
      double-blind, placebo-controlled, randomized, two-arm study. Participants in both treatment
      groups will be given exercise therapy in accordance with the early active mobilization
      protocol and appropriate splint will be given to be used while exercising.
    


Intervention name(s): low level laser therapy
Intervention type(s): Device
Intervention description(s): We will use laser light that has continuous wave mode, power of 100 mW, energy density of 7,5 joule/cm2, treatment time as 300 seconds.
Other intervention name(s): Sham laser therapy
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Chronic Clinical Effect of Acetazolamide
Condition: Hypertension, Pulmonary
MeSH terms: Hypertension, Pulmonary; Hypertension
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The study seeks primarily to determine the chronic clinical effect of AZA on exercise
      capacity (6MWD) compared to placebo.
    

Detailed description: 
      Pulmonary hypertension (PH) of various etiologies causes dyspnea, impairs exercise
      performance and is associated with reduced quality of life (QoL) and survival. Treatment
      options include therapy for any underlying causes, pulmonary vasodilator drugs, oxygen and,
      in selected cases, pulmonary endarterectomy or lung transplantation. Unfortunately, PH
      specific drugs are expensive, associated with side effects and even combined pharmacological
      treatment is often not sufficient to achieve clinical benefits. Therefore, novel therapeutic
      drugs are needed. We have recently demonstrated that sleep related breathing disorders, which
      are common in PH patients, can be improved by both nocturnal oxygen therapy and acetazolamide
      (AZA). AZA is a carbonic anhydrase (CA) inhibitor that acts as a respiratory stimulant
      thereby improving oxygenation and possibly PH. There are even data suggesting that
      CA-inhibitors have a direct pulmonary vasodilator effect. However, the potential role of AZA
      in the treatment of PH has not been conclusively studied. Therefore, the purpose of the
      current project is to investigate, the chronic clinical effects of AZA in PH patients.
    

Intervention name(s): Acetazolamide; Placebo
Intervention type(s): Drug; Drug
Intervention MeSH terms: Acetazolamide
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Treatment Outcome; Acetazolamide
Effect of Combined Use of Ivermectin and Colchicine in COVID-19 Patients
Condition: COVID-19
MeSH terms: COVID-19
Study type: Interventional
Phase: Phase 4

Summary: 
      The aim of this study will be to investigate the efficacy of use of combination of Ivermectin
      and colchicine on severity and outcome Of COVID 19 infection.
    


Intervention name(s): Ivermectin + colchicine; Colchicine
Intervention type(s): Drug; Drug
Intervention description(s): In addition to the local standard of care for COVID 19 patients, the patient will receive Ivermectin + colchicine; In addition to the local standard of care for COVID 19 patients, the patient will receive colchicine
Intervention MeSH terms: Ivermectin; Colchicine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Efficacy and Safety of Polyene Phosphatidylcholine in Treatment of Patients With Acute Drug-induced Liver Injury
Condition: Acute Drug Induced Liver Injury
MeSH terms: Chemical and Drug Induced Liver Injury; Wounds and Injuries
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to explore the efficacy and the safety of polyene
      phosphatidylcholine Injection in patients with acute drug-induced liver injury after 2-4
      weeks of treatment.
    

Detailed description: 
      This study is a phase IV study in subjects with acute drug-induced liver injury. As designed,
      the study will include a screening period of up to 1 week, 2 to 4 weeks of treatment, and 1
      week of safety follow-up. The eligible subjects will randomly be assigned to polyene
      phosphatidylcholine group or magnesium isoglycyrrhizinate group to receive single-blind
      treatment with a ratio of 1:1.
    

Intervention name(s): Polyene phosphatidylcholine injection 930 mg QD; Magnesium Isoglycyrrhizinate injection 200 mg QD
Intervention type(s): Drug; Drug
Intervention description(s): Polyene phosphatidylcholine injection 930mg, diluted with 5% glucose solution 250ml, once a day, at least 2 weeks but no more than 4 weeks.; Magnesium isoglycyrrhizinate injection 200mg, diluted with 5% glucose solution 250ml, once a day, at least 2 weeks but no more than 4 weeks.
Intervention MeSH terms: Polyene phosphatidylcholine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: ADILI
Brain Derived Neurotropic Factor Response to Aerobic Exercise Intensity in Depressive Patients.
Condition: Depressive Disorder; Depressive Disorder, Major
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Study type: Interventional

Summary: 
      Acute aerobic exercise improves affective stats in patients with mental illnesses. Brain
      derived neurotropic factor (BDNF) may be a biological mechanism that contributes to the
      affective benefits. The magnitude of the increase of serum BDNF might be exercise intensity
      dependent, but no study has compared low high-aerobic-intensity training at 90-95 % of the
      maximal heart rate (HRmax) with long-slow-distance training at 70 % of the HRmax in patients
      with depression.

      The aim of this study is to compare changes in serum BDNF levels after high-aerobic-intensity
      training and long-slow-distance training in a intra-individual design in patients suffering
      from depression. The results will give indications of a possible difference in BDNF response
      between aerobic intensities and may be uses as pilot data for calculating sample size.
    


Intervention name(s): High aerobic intensity training (HIT); Long slow distance training (LSD)
Intervention type(s): Behavioral; Behavioral
Intervention description(s): One training session, high aerobic intensity training (HIT) at 90-95 % of the maximal heart rate (HRmax); One training session, long slow distance training (LSD) at 70 % of the HRmax
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Exercise therapy
Study of TAK-935 as an Adjunctive Therapy in Participants With Developmental and/or Epileptic Encephalopathies
Condition: Developmental and/or Epileptic Encephalopathies
MeSH terms: Brain Diseases; Epilepsy
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of this study is to characterize the multiple-dose safety and tolerability
      profile of TAK-935 in adult participants with developmental and/or epileptic
      encephalopathies.
    

Detailed description: 
      The drug being tested in this study is called TAK-935. TAK-935 is being tested to treat
      people who have developmental and/or epileptic encephalopathies. This study will look at
      safety, tolerability and pharmacokinetics of people who take TAK-935. Study drug will be
      administered in a double-blind manner in Part 1 and in an open-label manner in Part 2.

      The study will enroll approximately 20 participants. Participants will be randomly assigned
      (by chance, like flipping a coin) to one of the two treatment groups in Part 1-which will
      remain undisclosed to the participant and study doctor during the study (unless there is an
      urgent medical need):

        -  TAK-935

        -  Placebo (dummy inactive pill) - this is a tablet that looks like the study drug but has
           no active ingredient

      Participants will receive placebo or 100 milligram (mg) TAK-935 tablets, orally or through
      stable G-tube/PEG tube, BID, in Part 1 (Day 1) and dose will be increased to 200 mg (Day 11)
      BID and to 300 mg (Day 21) BID in dose titration period. All participants who complete the
      Double-Blind Treatment Period in Part 1 will have the option to continue directly into the
      Open-Label Treatment Period in Part 2 where they will receive TAK-935 as two 100 mg tablets
      (total dose is 200 mg TAK-935) orally or through G-tube/PEG tube, BID and dose will be
      increased to three 100 mg tablets (total dose is 300 mg TAK-935), orally, BID (Day 41). This
      dose level will be maintained until the final visit (Day 85) for the dose de-escalation
      phase.

      This multi-center trial will be conducted in North America. The overall time to participate
      in this study is 121 days excluding screening period of 30-41 days. Participants will make
      multiple visits to the clinic, and a follow-up phone call will be conducted on Day 91 and at
      the end of the 30-day follow-up period (Day 121), participants will return to the clinic for
      a follow-up assessment.
    

Intervention name(s): TAK-935; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): TAK-935 tablets.; TAK-935 placebo-matching tablets.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Drug therapy
PSMA-PET/CT for Prostate Cancer
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      Prostate cancer is the most frequently occurring male cancer in Belgium. Patients who have
      been treated for prostate cancer, i.e. by surgery and/or radiotherapy, in a substantial
      degree suffer from a tumor recurrence, often diagnosed by an increase in serum tumor marker
      PSA (prostate specific antigen) within the first few years. In these patients with evidence
      of a tumor recurrence after primary treatment, it is important to most exactly define the
      location(s) of tumor, to guide appropriate therapy by surgery, radiotherapy and/or
      hormonotherapy. In so-called oligo-metastatic disease targeted therapy may still be curative
      and prevent the disease from spreading to distant locations. Therefore it is of paramount
      importance to have an accurate tool of medical imaging to localize all possible locations to
      be treated.

      With some patients, the PSA-value is so low, that conventional nuclear medicine bone scanning
      or radiological CT or MRI cannot determine where the metastases are. Therefore, [18F]-Choline
      PET-CT was introduced to improve diagnostic imaging performance. However, in 30 to 40 percent
      of patients choline-PET does not localize tumor either, especially in small tumors and/or
      very low PSA values.

      The PSMA PET is already routinely used in many European centres, and has shown a superior
      accuracy in these patients as compared to conventional imaging techniques. This has been a
      very consistent finding in scientifically reported patient studies.

      Most of these investigations have been performed with PSMA labeled with Gallium-68. The
      investigators in Ghent, as others, have labeled PSMA with Fluor-18. This tracer provides many
      advantages, including a higher production yield enabling more patients to be scanned. Also
      from a perspective of radioprotection and financial costs, Fluor-18 is a better choice.
      Moreover, several recent studies, comparing Fluor with Gallium modalities seem to suggest
      equivalent or better diagnostic results, possibly because of a lower aspecific background
      activity.
    


Intervention name(s): 18F-PSMA
Intervention type(s): Diagnostic Test
Intervention description(s): 18F-PET imaging
Intervention model: Single Group Assignment
Intervention model description: intravenous [18F]-PSMA-11
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: prostate cancer; biochemical recurrence; 18F-PET imaging
A Study to Evaluate Safety and Efficacy of Lebrikizumab in Participants With Chronic Obstructive Pulmonary Disease (COPD)
Condition: Chronic Obstructive Pulmonary Disease
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Study type: Interventional
Phase: Phase 2

Summary: 
      Phase II, randomized, double-blind, placebo-controlled, parallel-group clinical trial of
      lebrikizumab in participants with COPD and a history of exacerbations who are treated with
      inhaled corticosteroid (ICS) and at least one long-acting bronchodilator inhaler medication.
      This study will be conducted to assess the safety, efficacy, and patient-reported outcome
      (PRO) measures.
    


Intervention name(s): Lebrikizumab; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Lebrikizumab 125 milligrams (mg) will be administered subcutaneously once in every 4 weeks.; Matching placebo will be administered subcutaneously once in every 4 weeks.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment