bioihbjkbjnl/mcl2 huggingface dataset:
RENABLATE-II Feasibility Study of Catheter Based Renal Denervation to Treat Resistant Hypertension - 157
Condition: Hypertension, Renal
MeSH terms: Hypertension, Renal; Hypertension
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a prospective, multi-center, non-randomized, feasibility study to assess the safety
      and effectiveness of renal artery sympathetic denervation using the investigational devices
      in subjects with resistant hypertension.
    


Intervention name(s): Celsius® ThermoCool® Renal Denervation
Intervention type(s): Device
Intervention description(s): The investigational device is indicated for the treatment of resistant hypertension by renal denervation.
Other intervention name(s): Multi-electrode Ablation Catheter
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Renal Sympathetic Denervation
the Effect of Trans-nasal Fixation of Endotracheal Tubes for Prone Ventilation
Condition: Prone Craniotomy; Endotracheal Intubation Fixation
Study type: Interventional

Summary: 
      The aim of this randomized controlled trial is to evaluate the clinical effects of
      trans-nasal ETT fixation for prone ventilation.
    


Intervention name(s): SFC
Intervention type(s): Device
Intervention description(s): The lubricated SFC passed nasally into the oropharynx under the visual guidance of visual laryngoscope to ensure that the cuff had passed through the posterior choanae and reached the oropharynx. The guide wire is removed and the balloon inflated with 5 ml normal saline. The catheter is then pulled slightly until the balloon is fixed and concealed by the soft palate . The ETT is anchored to the SFC with a cable tie .
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Zonisamide in Addition to E-CPT-C for Veterans With PTSD and Comorbid Alcohol Dependence
Condition: Alcohol Dependence; Post-Traumatic Stress Disorder (PTSD)
MeSH terms: Alcoholism; Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a randomized, controlled trial with 50 veterans diagnosed with post-traumatic stress
      disorder (PTSD) and comorbid alcohol dependence. Veterans will be randomized to receive
      either zonisamide (400 mg) or placebo for 12 weeks in a double blind fashion. Randomization
      will be done using 3:1 ratio and will be performed by our research pharmacy using a random
      assignment in blocks of 4- 3 will be assigned to active medication and 1 to placebo.
      Medication will be titrated over a 6 week titration phase followed by a 6 week treatment
      phase. All veterans will receive E-CPT-C therapy for the 12 weeks of treatment; E-CPT-C will
      be provided by trained and qualified clinicians with extensive experience providing E-CPT-C.
      Veterans will be recruited primarily through advertisement, but also through the clinical
      facilities at the VA and from other collaborators.
    


Intervention name(s): Enhanced-Cognitive Processing Therapy-C (E-CPT-C); Zonisamide; Placebo
Intervention type(s): Behavioral; Drug; Drug
Other intervention name(s): Zonegran
Intervention MeSH terms: Zonisamide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Alcohol Dependence; Post-Traumatic Stress Disorder (PTSD); Zonisamide; Cognitive Processing Therapy (CPT)
A Nordic Phase II Study of PTCL Based on Dose-intensive Induction and High-dose Consolidation With ASCT
Condition: Peripheral T-Cell Lymphoma
MeSH terms: Lymphoma; Lymphoma, T-Cell; Lymphoma, T-Cell, Peripheral
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a phase II prospective non-randomised clinical trial in newly diagnosed and
      previously untreated adult patients in the age range 18-60 (67) years with peripheral T-cell
      lymphoma.

      The treatment schedule will consist of three phases: induction and high-dose consolidation,
      followed by autologous stem cell rescue. There will be two different induction schedules: one
      for patients in the age range 18-60 years and one for patients aged over 60 years.
    


Intervention name(s): CHOEP + G-CSF followed by BEAM
Intervention type(s): Drug
Intervention description(s): CHOEP:
Cyclophosphamide: 750 mg/m2 i.v. day1 Hydroxydaunorubicin: 50 mg/m2 i.v. day1 Vincristine: 1.4 mg/m2 (max 2 mg) i.v. day 1 Etoposide: 100 mg/m2 i.v. day 1-3 Prednisone: 100 mg daily p.o. day 1-5
BEAM:
Carmustine: 300 mg/m2 i.v. day 1 Etoposide: 100 mg/m2 i.v. x2 daily day 2-5 Cytosine arabinoside: 200 mg/m2 i.v. x2 daily or 400 mg/m2 as continuous 24 hrs i.v. infusion, day 2-5 Melphalan: 140 mg/m2 i.v. day 6
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Study of Danicopan in Participants With Paroxysmal Nocturnal Hemoglobinuria With Inadequate Response to Eculizumab
Condition: Paroxysmal Nocturnal Hemoglobinuria (PNH)
MeSH terms: Hemoglobinuria; Hemoglobinuria, Paroxysmal
Study type: Interventional
Phase: Phase 2

Summary: 
      To determine the effectiveness of ACH-0144471 (also known as danicopan and ALXN2040) in
      improving anemia when given with eculizumab for 24 weeks in participants with PNH. Danicopan
      dose may be increased within each participant, to a maximum of 200 milligrams (mg) three
      times daily (TID) based on safety and efficacy at protocol-specified time points.
    

Detailed description: 
      The purpose of this study is to determine the effectiveness of danicopan in improving anemia,
      as measured by increased blood hemoglobin, when given with eculizumab (a drug commonly used
      for treatment of PNH) for 24 weeks in participants with PNH.

      The 24-week treatment period was followed by a long-term extension phase. In the extension
      phase, participants received the same danicopan dose plus eculizumab as they were receiving
      at the end of 24-week treatment phase.

      Results are reported for the 24-week treatment period.
    

Intervention name(s): Danicopan; Eculizumab
Intervention type(s): Drug; Drug
Intervention description(s): Participants received a daily oral dose of danicopan TID during the treatment period.; Participants received intravenous eculizumab administered at the participant's usual dose and schedule.
Other intervention name(s): Soliris
Intervention MeSH terms: Eculizumab
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Intervention model description: Four groups will be studied and enrolled sequentially.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: PNH; Paroxysmal Nocturnal Hemoglobinuria; ACH-0144471; Danicopan; Eculizumab; ALXN2040
Impact of Oximetry on Hospitalization in Acute Bronchiolitis
Condition: Bronchiolitis
MeSH terms: Bronchiolitis
Study type: Interventional
Phase: Phase 4

Summary: 
      To determine, in previously healthy infants 6 weeks to 12 months of age, diagnosed with acute
      bronchiolitis and monitored by hourly oximetry, if the probability of hospitalization within
      72 hours of arrival in those whose oxygen saturation display is manipulated 3 percentage
      points above the true measurements is significantly lower in comparison to those whose
      monitors display true saturations.
    

Detailed description: 
      This is the first bronchiolitis study to examine the clinical and economic impact of making
      disposition decision on primarily clinical grounds, while blinding the physicians to oxygen
      saturations by providing them with either true saturation measurements or those which are 3
      percentage points above the true values. Although physiologically insignificant and within
      the measurement error of the instrument, this difference has been shown to be perceived as
      clinically relevant and to have a major hypothetical impact on disposition, without any
      evidence to support this belief.

      We hope to find out if children with oxygen saturations above or in the vicinity of the
      threshold recommended for initiation of oxygen therapy by the AAP can be safely discharged
      based on their clinical appearance rather than to have their hospitalization dictated by a
      locally defined number. This study will hopefully provide much needed evidence necessary to
      help us interpret the oximetry results more meaningful which may in turn lead to fewer
      hospitalizations, shorter length of hospital stay and lower health care costs.
    

Intervention name(s): True saturation values displayed; Altered saturation values displayed.
Intervention type(s): Other; Other
Intervention description(s): Physicians will be presented with real saturations.; Physicians will be presented with saturation measurements three percentage points above the true values.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Diagnostic
Keywords: bronchiolitis; hospitalization; oximetry; pediatrics
Histocompatibility Leukocyte Antigen (HLA)-A*0201 Restricted Peptide Vaccine Therapy in Patients With Esophageal Cancer
Condition: Esophageal Cancer
MeSH terms: Esophageal Neoplasms
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of this study is to evaluate the safety and time to progression of HLA-A*0201
      restricted epitope peptides URLC10, VEGFR1 and VEGFR2 emulsified with Montanide ISA 51.
    

Detailed description: 
      URLC10 has been identified as cancer specific molecules especially in non small cell lung
      cancer using genome-wide expression profile analysis by cDNA microarray technique. In a prior
      study, it has been shown that URLC10 is upregulated in human esophageal tumors. VEGF receptor
      1 and 2 are essential targets to tumor angiogenesis, and we identified that peptides derived
      from these receptors significantly induce the effective tumor specific CTL response in vitro
      and vivo. According to these findings, in this trial, we evaluate the safety, immunological
      and clinical response of those peptides. Patients will be vaccinated twice a week for 8
      weeks. On each vaccination day, the URLC10-117 peptide(1mg), VEGFR1 peptide(1mg) and VEGFR2
      peptide(1mg) mixed with Montanide ISA 51 will be administered by subcutaneous injection.
      Repeated cycles of vaccine will be administered until patients develop progressive disease or
      unacceptable toxicity, whichever occurs first. In the phase I study, we evaluate the safety
      and tolerability of these peptide vaccines. In the following phase II study, we evaluate the
      immunological and clinical response of this vaccine therapy.
    

Intervention name(s): URLC10, VEGFR1 and VEGFR2
Intervention type(s): Biological
Intervention description(s): Patients will be vaccinated twice a week for 8 weeks. On each vaccination day, the URLC10 peptide (1mg), VEGFR1 peptide (1mg) and VEGFR2 peptide (1mg) mixed with Montanide ISA 51 will be administered by subcutaneous injection.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Peptide Vaccine; URLC10; VEGFR1; VEGFR2
Matched Unrelated Donor Stem Cell Transplantation (MUD-SCT) After Dose-reduced Conditioning for Patients With Multiple Myeloma and Relapse After Autologous SCT
Condition: Multiple Myeloma
MeSH terms: Multiple Myeloma; Neoplasms, Plasma Cell
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine whether a reduced intensity conditioning regimen
      followed by allogeneic stem cell transplantation from unrelated donors is a feasible and
      effective treatment for patients with multiple myeloma who failed a previous autologous stem
      cell transplantation.
    

Detailed description: 
      The purpose of this study is to determine whether a reduced intensity conditioning regimen
      followed by allogeneic stem cell transplantation from unrelated donors is a feasible and
      effective treatment for patients with multiple myeloma who failed a previous autologous stem
      cell transplantation.
    

Intervention name(s): allogeneic HSCT
Intervention type(s): Procedure
Intervention description(s): dose-reduced conditioning regimen
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Hematopoietic Stem Cell Transplantation; Multiple Myeloma
Clinical Trial to Explore the Papilocare Gel Efficacy to Repair the Cervico-vaginal Mucosa With Lesions Caused by HPV
Condition: Human Papilloma Virus Infection; Human Papilloma Virus; Cervix Lesion
MeSH terms: Papillomavirus Infections; Papilloma
Study type: Interventional

Summary: 
      Phase II, exploratory, randomized, open, controlled and parallel groups clinical trial to
      evaluate the effectiveness of exploratory gel Papilocare in the repair of the cervico-vaginal
      mucosa with lesions caused by HPV. All the patients included in the study will be Randomized
      (1:1:1).
    

Detailed description: 
      Phase II, exploratory, randomized, open, controlled and parallel groups clinical trial to
      evaluate the effectiveness of exploratory gel Papilocare in the repair of the cervico-vaginal
      mucosa with lesions caused by HPV. All the patients included in the study will be Randomized
      (1:1:1) to Arm A (Papilocare schedule A), Arm B (Papilocare schedule B) and Arm C (usual
      clinical practice -without treatment-). Selection period of 1 month, followed by
      randomization and 6 months of treatment followed by a period of another 6 months without
      treatment. Patients will visit the site into a total of 5 visits throughout the study.
    

Intervention name(s): Papilocare vaginal gel
Intervention type(s): Device
Intervention description(s): Papilocare is a gel vaginally administered by a single-dose cannula. Vaginal gel formulation is effective as a local treatment with controlled systemic absorption and rapid and efficient distribution
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: HPV
Intravenous Fish Oil in Critically Ill Cardiac Patients
Condition: Coronary Artery Disease
MeSH terms: Coronary Artery Disease
Study type: Interventional
Phase: Phase 3

Summary: 
      A large body of evidence has accumulated showing that n-3 PUFAs exert extensive cardiac
      effects. The development of commercial solutions of FO opens perspectives for therapeutic
      applications in patients with acute cardiac conditions.the 3 following hypotheses will be
      addressed in patients requiring cardiac surgery under cardiopulmonary bypass or after
      myocardial infarction:perioperative /post-PTCA intravenous fish oil modifies the composition
      of membrane phospholipids in platelets and cardiac cells, blunts the physiological response
      to cardiac surgery/myocardial infarction, and reduces the incidence of arrhythmias, and
      reduces the occurrence of systolic dysfunction.
    

Detailed description: 
      A. Randomized trial in 40 cardiac surgery patients Early rapid infusion of fish oil (3 times
      in 24 hours) in cardiac surgery patients.

      B. Randomized trial 20 myocardial infarction patients (abandonned) Continuous infusion of the
      same dose over 24hrs in the myocardial infarction patients

      Additional trial in healthy volunteers (investigating physiological changes after cardiac
      study):

      -Open trial in 8 healthy lean volunteers to investigate the impact of the same 0.6 g/kg FO
      dose IV (Week 1: 3hrs), and then orally on week 2, on platelet n-3 PUFA incorporation,
      platelet function, heart rate and peak flow response to stress test.
    

Intervention name(s): Fish oil emulsion; Saline
Intervention type(s): Drug; Drug
Intervention description(s): 0.2 g/kg FO, 3 times in 24 hours, infused over 3 hours each in cardiac surgery, or continuous infusion of 0.6 g/kg post PTCA; 3 infusions, perioperative or post-PTCA
Other intervention name(s): Omegaven,Fresenius Kabi AG
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Fish oil supplement; n-3 PUFA; Cardiac function; Membrane incorporation; Inflammation; Clinical outcome
Study of the Safety, Tolerability, and Pharmacokinetics of LHW090 in Patients With Moderately Impaired Renal Function
Condition: Chronic Kidney Disease (CKD)
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic; Renal Insufficiency
Study type: Interventional
Phase: Phase 2

Summary: 
      This was a randomized, double-blind, parallel group, placebo-controlled study, in two
      sequential parts that evaluated the renal safety, tolerability and pharmacokinetics of LHW090
      in patients with moderately impaired renal function.
    


Intervention name(s): LHW090; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): LHW090 is orally administered; Matching placebo of LHW090
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Chinese Medicine(Hu Yang Yang Kun Formula) for Primary Ovarian Insufficiency
Condition: Primary Ovarian Insufficiency
MeSH terms: Primary Ovarian Insufficiency; Menopause, Premature
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of this research is providing valuable traditional chinese medicine theory and
      formula in treating Primary Ovarian insufficiency.
    

Detailed description: 
      Primary ovarian insufficiency is a problem that is to be solved urgently in the field of
      reproductive endocrine. According to the basic theory of traditional Chinese Medicine and
      clinical experience, investigators developed a Chinese medicine formula(Hu yang yang
      kun,Hyyk). This research is designed according to the principle of randomized double blind
      control and evaluated the effectiveness and safety of Hyyk, hope to provide a kind of
      effective medicine in treating primary ovarian insufficiency.
    

Intervention name(s): Chinese medicine granules (HuYang Yang Kun Formula); dehydroepiandrosterone
Intervention type(s): Other; Dietary Supplement
Intervention description(s): Take Chinese medicine granules (HuYang Yang Kun Formula), 1 sack every time,twice a day Take DHEA(dehydroepiandrosterone) placebo,1 capsule every time ,once a day. Treatment for 3 months Both Chinese Medicine formula granules and DHEA placebo were produced by Jiangyin Medical &pharmaceutical limited company in Jiangsu province; The DHEA( dehydroepiandrosterone)25mg,1 capsule every time once a day. Take Chinese medicine granules placebo , 1 sack every time,twice a day Treatment is 3 months. DHEA were produced by General Nutrition Center(GNC)company in America and The placebo granules of Chinese Medicine were produced by Jiangyin Medical &pharmaceutical limited company in Jiangsu province.
Intervention MeSH terms: Dehydroepiandrosterone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: primary ovarian insufficiency; TCM intervention
Exercise and Arterial Stiffness in Systemic Lupus Erythematosus
Condition: Systemic Lupus Erythematosus
MeSH terms: Lupus Erythematosus, Systemic
Study type: Interventional

Summary: 
      Patients with Systemic Lupus Erythematosus (SLE) have increased arterial stiffness, which
      leads to cardiovascular diseases (CVD) of arteriosclerotic origin, which are the main cause
      of mortality in these patients. Exercise is a modifiable factor that reduces cardiovascular
      mortality and associated risk factors in the general population. Preliminary studies suggest
      that exercise may improve endothelial function and lipid profile in patients with SLE.
      However, whether meeting the international physical activity guidelines from the American
      College of Sports Medicine (ACSM; i.e. ≥150 min / week of moderate to vigorous intensity
      physical activity) can improve arterial stiffness (subclinical atherosclerosis marker) and
      inflammation is unknown.

      The primary aim of this study is to assess the effect of an exercise program based on meeting
      the ACSM physical activity guidelines on arterial stiffness and inflammation in patients with
      SLE.

      The secondary aim is to assess the effect of an exercise program based on meeting the ACSM
      physical activity guidelines on endothelial function, oxidative stress, as well as other
      cardiometabolic risk factors, physical fitness, health-related quality of life, and other
      psychosocial outcomes.

      Our hypothesis is that meeting the ACSM guidelines will improve arterial stiffness and
      inflammation in patients with SLE.

      The study is a non-randomized clinical trial. To minimize selection bias, participants in the
      intervention and control groups will be matched by age, BMI, and disease activity (SLEDAI),
      which are important contributors to arterial stiffness.
    


Intervention name(s): Aerobic exercise
Intervention type(s): Behavioral
Intervention description(s): 12-weeks aerobic exercise intervention based on the physical activity guidelines from the American College of Sports Medicine (≥150 min/week of moderate to vigorous [40-85% of the individual's heart rate reserve] exercise). Participants will perform the exercise on treadmills at the hospital. The volume and intensity of the exercise will progressively increase throughout the 12 weeks.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: Arterial stiffness; Markers of Inflammation; Exercise; Physical fitness; Cardiovascular risk; Autoimmune diseases
Evaluation of Safety and Efficacy of 17-Beta Estradiol in Treatment of Atrophic Vaginitis: An Extension Trial
Condition: Menopause; Postmenopausal Vaginal Atrophy
MeSH terms: Vaginitis; Atrophic Vaginitis
Study type: Interventional
Phase: Phase 3

Summary: 
      This trial was conducted in the United States of America (USA). This trial aimed to evaluate
      safety and efficacy of 17-beta Estradiol in the treatment of atrophic vaginitis.
    


Intervention name(s): estradiol, 25 mcg
Intervention type(s): Drug
Intervention MeSH terms: Estradiol
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment