bioihbjkbjnl/mcl2 huggingface dataset:
The Impact of Minimally Invasive Restorative Techniques on Dental Pain in Pregnant Women
Condition: Dental Pain; Patient Satisfaction
MeSH terms: Toothache
Study type: Interventional
Phase: Phase 2

Summary: 
      The aim of the present study was to compare the effectiveness of chemo-mechanical caries
      removal using Papacarie-Duo and Atraumatic Restorative Treatment (ART) in reducing dental
      pain in pregnant women.
    

Detailed description: 
      A randomized controlled clinical trial was conducted in 2019 and included 162 pregnant women
      visiting family health centers in Alexandria, Egypt with dental pain due to caries not
      extending to pulp who were randomly assigned into Papacarie-Duo group (n=82) and ART group
      (n=80) after stratification by number of treated surfaces
    

Intervention name(s): Papacarie; Atraumatic Restorative Treatment
Intervention type(s): Drug; Drug
Intervention description(s): Papacarie was introduced into the cavity using the applicator and left for 40 seconds. A blunt excavator was used to remove the softened dentin. The remaining gel was removed using a cotton pellet. When there was no change in gel color, the cavity was considered caries free. The cavity was then filled with high viscosity glass ionomer cement (GIC) in an encapsulated form (Riva Self-Cure, SDI Limited, Bayswater, VIC, Australia). A mechanical mixer was used to mix the capsule for 10 seconds, the capsule was placed into the applicator to apply the GIC into the cavity. For occluso-proximal cavities, a matrix strip with a wooden wedge was used to provide the appropriate contour of the restoration. A gloved finger was used to apply pressure on the GIC for one minute and occlusion was checked and excess material was removed; The tooth was cleaned with a wet cotton pellet to remove debris and plaque. Caries was removed using sharp spoon excavators (Darby-Perry #220/221, #17 DE, Hu-Friedy, Chicago, USA), followed by cleaning the cavity using a small wet cotton pellet and finally dried with a dry cotton pellet. The cavity was considered caries-free when a leather-hard texture was reached and the excavator did not stick anymore. GIC was used to restore the cavity using the same technique described for the other group.
Other intervention name(s): Papacarie-Duo; ART
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Minimally Invasive Dentistry
Study Use of PPSB-SD and VP-VI in Patients With Anticoagulant Therapy and Undergoing Acute CPB Surgery
Condition: CPB; Oral Anticoagulant Therapy
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study was to study the efficacy of PPSB-SD and VP-VI in patients, who
      received anticoagulant treatment and who had to undergo acute cardiac surgery with a
      cardiopulmonary bypass (CPB).
    

Detailed description: 
      The value of oral anticoagulants such as coumarin derivatives as a therapy and in the
      prophylaxis of thrombosis is universally acknowledged. These medicinal products are used in
      the prevention of cerebral infarction, in patients with atrial fibrillation and in the
      secondary prevention of myocardial infarction. In case of elected surgery, the effect of
      coumarin derivatives can be reversed by a termination of the coumarin treatment and the
      administration of vitamin K orally, i.m. or i.v., which will restore the production of the
      vitamin K dependent coagulation factors. For patients due to undergo acute surgery, it will
      be unfavourable to await endogenous production of vitamin K dependent coagulation factor
      production.After CPB surgery, the patients need to be in a controlled coagulated state. Two
      products suitable to rapidly increase the concentration of vitamin K dependent coagulation
      factors, are fresh frozen plasma (FFP) and prothrombin complex concentrates (PCC). These
      products contain factor II, VII, IX and X and help to restore normal levels of the clotting
      fraction.Administration of these products prior to CPB surgery will decrease the INR to a
      level that is acceptable for surgery. In the Academic Hospital Leuven the standard procedure
      in cases of acute and elected CPB surgery is administration of VP-VI, a FFP-product made by
      OCTAPHARMA. In this study the standard treatment of 2x 400 ml VP-VI was compared with a
      treatment of PPSB Solvent Detergent® (PPSB-SD) according to the prescription regimen of
      CAF-DCF. PPSB-SD is a PCC product made by Sanquin Plasma Products (the Netherlands) for
      CAF-DCF (Belgium). The regimen as prescribed by CAF-DCF enables to calculate the quantity of
      PPSB-SD to administer on the basis of the patient's weight, the initial INR and the target
      INR. The expected outcome of the study was that in patients receiving PPSB-SD the target INR
      will be reached more frequently and more rapidly compared to patients receiving VP-VI.
    

Intervention name(s): PPSB-SD
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: CPB; oral anticoagulant therapy; plasma; PCC
Efficacy and Safety of Factor VIIa on Rebleeding After Surgery for Spontaneous Intracerebral Hemorrhage (ICH)
Condition: Intracerebral Hemorrhage
MeSH terms: Cerebral Hemorrhage; Hemorrhage
Study type: Interventional
Phase: Phase 2

Summary: 
      Although the role of surgical treatment is still controversial, surgical evacuation of
      intracerebral hematoma is a frequent practice. Rebleeding is a frequent complication in
      patients submitted to hematoma evacuation. It has been reported that smaller postoperative
      volume of hematoma is associated with a better outcome. The investigators hypothesize that
      the administration of Factor VIIa (Eptacog alfa) immediately after surgical evacuation of the
      hematoma can reduce postoperative rebleeding.

      Aims of the Study:

      This study will investigate:

        1. The efficacy of Eptacog alfa in preventing or reducing rebleeding after surgery for
           spontaneous supratentorial ICH; and

        2. The safety of product administration
    

Detailed description: 
      The primary endpoint is the evaluation of efficacy of Factor VIIa (Eptacog alfa, NovoSeven,
      Novo Nordisk) on rebleeding after surgery for primary supratentorial ICH. All patients
      included in the study will perform a CT scan within 3 hours before surgery, then immediately
      after surgery, and 18-30 hours after surgery. The hematoma volume will be evaluated by a
      multi-slice CT scan. All CT scan images will be sent to the Coordinating Center where the
      hematoma volume will be evaluated by a dedicated software by the same investigator who will
      be unaware of the treatment (investigator- blinded study).

      SAFETY EVALUATION:

      Seventeen episodes of thrombotic spontaneous adverse events have been reported after
      administration of 480,000 standard doses of Eptacog alfa in hemophilic patients. These
      episodes include myocardial infarction, acute cerebrovascular thrombosis, disseminated
      intravascular coagulation (DIC), deep venous thrombosis (DVT) and pulmonary embolism.

      Before and after hematoma removal will be evaluated ECG, myocardiac enzymes, coagulation
      profile, CT scan (looking for ischemic events) and venous echodoppler ultrasound of lower
      extremities.
    

Intervention name(s): rFactor VIIa (Eptacog alfa, NovoNordisk); rFVIIa; Sodiun chloride 0.9%
Intervention type(s): Drug; Drug; Other
Intervention description(s): rFVIIa will be admistered as single bolus at the dosage of 100 mcg/Kg b.w.; Patients with spontaneous supratentorial ICH will be treated with rFVII after hematoma evacuation; Bolus injection of sodium chloride 0.9% after surgical hematoma removal
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: Spontaneous intracerebral hemorrhage; ICH; intracerebral rebleeding; cerebral hematoma evacuation; cerebral hematoma volume
Efficacy and Safety of 4.5mg PEG-rhG-CSF Per Cycle in Preventing Neutropenia After Intensive Chemotherapy for Breast Cancer
Condition: Breast Cancer; Neutropenia
MeSH terms: Breast Neoplasms; Neutropenia
Study type: Interventional
Phase: Phase 4

Summary: 
      This is a prospective, single-center, single-arm clinical study, to evaluate the clinical
      efficacy, safety and tolerance of patients with early breast cancer receiving ddEC adjuvant
      chemotherapy, accepting PEG-rhG-CSF as primary prevention of neutropenia.
    


Intervention name(s): PEG-rhG-CSF
Intervention type(s): Drug
Intervention description(s): 4.5mg per cycle, 24 hours after chemotherapy
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
24-hour Intraocular Pressure (IOP) Control With the Bimatoprost/Timolol Fixed Combination
Condition: Glaucoma
MeSH terms: Glaucoma
Study type: Interventional
Phase: Phase 4

Summary: 
      The objective of this crossover, randomized, placebo controlled, double-masked study is to
      compare the short-term (12 weeks) mean 24-hour IOP control and safety of the new fixed
      combination (bimatoprost/timolol, BTFC) given PM with placebo once in the morning, versus
      BTFC given AM with placebo once in the evening versus bimatoprost given in the evening in
      patients with exfoliative glaucoma (XFG).
    

Detailed description: 
      PRIMARY STUDY OBJECTIVES

        -  To show that the mean 24-hour IOP control obtained with BTFC (morning or evening) is
           statistically better to that with bimatoprost monotherapy given once on the evening.

        -  To demonstrate that the fixed combination will provide a significantly better IOP
           control in the morning when dosed in the evening.

        -  To test whether the mean 24-hour IOP control obtained with BTFC given once in the
           evening may be statistically better to that with BTFC given once in the morning.

        -  To show whether there will be less 24-hour fluctuation of IOP with the evening dosing of
           BTFC.

      STUDY POPULATION

      Consecutive newly-diagnosed, or suitably washed-out patients with exfoliative glaucoma (XFG)
      who exhibit a mean untreated IOP greater than 25 mm Hg at baseline (10:00).
    

Intervention name(s): Drug: bimatoprost/timolol fixed combination AM; Bimatoprost/timolol fixed combination dosed PM
Intervention type(s): Drug; Drug
Intervention description(s): 3-month chronic dosing in the morning; Evening dosing of bimatoprost/timolol fixed combination for a period of 3 months
Intervention MeSH terms: Timolol; Bimatoprost
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: 24-hour IOP control
Radiation Therapy to Relieve Symptoms in Patients With Non-small Cell Lung Cancer
Condition: Fatigue; Lung Cancer; Nausea and Vomiting; Pain; Pulmonary Complications; Quality of Life
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Fatigue; Nausea; Vomiting
Study type: Interventional
Phase: Phase 3

Summary: 
      RATIONALE: Radiation therapy may relieve symptoms in patients with non-small cell lung
      cancer. It is not yet known which regimen of radiation therapy is most effective in relieving
      symptoms in patients with non-small cell lung cancer.

      PURPOSE: Randomized phase III trial to compare the effectiveness of different regimens of
      radiation therapy to relieve symptoms in patients who have non-small cell lung cancer.
    

Detailed description: 
      OBJECTIVES: I. Compare the efficacy of two schedules of radiotherapy in the palliation of
      symptoms in patients with non-small cell lung cancer. II. Compare the toxicity of these two
      regimens in these patients. III. Compare the quality of life and survival of patients treated
      with these two regimens.

      OUTLINE: This is a randomized, multicenter study. Patients are stratified according to
      center, weight loss in the previous 6 months (no greater than 10% vs greater than 10%), and
      performance status (ECOG 0 or 1 vs 2 or 3). Patients are randomized to undergo radiotherapy
      as 5 fractions over 5 days or 1 fraction on 1 day. Quality of life is assessed before
      treatment, weekly for 5 weeks, and monthly thereafter. Patients are followed weekly for 5
      weeks, then every 2 months for 1 year.

      PROJECTED ACCRUAL: A total of 210 patients will be accrued for this study.
    

Intervention name(s): fatigue assessment and management; nausea and vomiting therapy; pain therapy; quality-of-life assessment; radiation therapy
Intervention type(s): Procedure; Procedure; Procedure; Procedure; Radiation
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: stage III non-small cell lung cancer; recurrent non-small cell lung cancer; squamous cell lung cancer; large cell lung cancer; stage IV non-small cell lung cancer; adenocarcinoma of the lung; adenosquamous cell lung cancer; fatigue; nausea and vomiting; pain; pulmonary complications; quality of life
Qualitative Analysis of Hospital Executives, Physician Administrators, and Hospital Legal Counsels' Perceptions of End-of-Life Care
Condition: End of Life Care
MeSH terms: Death
Study type: Observational

Summary: 
      Interviewing hospital executives, physician administrators and hospital legal counsel who
      work in a hospital setting (academic, governmental, private or community hospital) about
      their perceptions concerning current and future end-of-life care provided in their facilities
    


Sampling method: Non-Probability Sample
Study population: 
        hospital executive, physician administrator or hospital legal counsel in a hospital setting
        (academic, governmental, private or community hospital)
      
Biospecimen description: 
      Qualitative Analysis
    
Keywords: executive; administrator; perceptions; legal counsel; end of life
Sorafenib Trial in Advanced and/or Recurrent Gastric Adenocarcinoma: Treatment Evaluation: STARGATE
Condition: Malignant Neoplasm of Stomach; Effects of Chemotherapy
MeSH terms: Neoplasms; Stomach Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      This study investigates the efficacy and safety profiles of sorafenib in combination of
      capecitabine and cisplatin, one of standard chemotherapy regimens in patients with advanced
      gastric cancer.
    


Intervention name(s): Capecitabine/Cisplatin + Sorafenib; Capecitabine/Cisplatin
Intervention type(s): Drug; Drug
Intervention description(s): Capecitabine 800 mg / m² po bid (D1-14) Cisplatin 60 mg / m² IV Day 1 Sorafenib 400 mg p.o. bid continuous dosing; Capecitabine 1000 milligram (mg) / m² po bid (D1-14) Cisplatin 80 mg / m² IV Day 1
Other intervention name(s): Xeloda; Nexavar; Xeloda
Intervention MeSH terms: Cisplatin; Capecitabine; Sorafenib
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: First line chemotherapy in advanced gastric cancer
A Study of JNJ-77242113 for the Treatment of Moderate-to-Severe Plaque Psoriasis
Condition: Plaque Psoriasis
MeSH terms: Psoriasis
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of the study is to evaluate the efficacy of an oral tablet formulation of
      JNJ-77242113 compared with placebo in participants with moderate-to-severe plaque psoriasis.
    

Detailed description: 
      The population of people living with moderate to severe psoriasis is approximately 3.5
      billion who are mostly managed with topical and conventional therapies. JNJ-77242113,
      investigational drug, targets the immune responses in the body and skin which impacts
      diseases, such as psoriasis and psoriatic arthritis and this study evaluates JNJ-77242113 as
      options of advanced therapies in moderate to severe plaque psoriasis. The hypothesis of this
      study is that an oral tablet formulation of JNJ-77242113 will result in superior efficacy
      compared with placebo as determined by the percentage of participants achieving Psoriasis
      Area and Severity Index (PASI) 75 (greater than or equal to [>=] 75 percentage [%]
      improvement in PASI) (PASI 75) response at Week 16. The total duration of this study is up to
      24 weeks which includes a screening period of less than or equal to (<=) 4 weeks, a 16-week
      placebo- controlled treatment period, and a follow-up visit approximately 4 weeks after the
      last administration of study intervention. Safety assessments include adverse events (AEs)
      monitoring, clinical safety laboratory assessments, electrocardiograms (ECGs), vital signs,
      physical examinations, concomitant medication monitoring, pregnancy testing, Columbia Suicide
      Severity Rating Scale (C-SSRS) and tuberculosis evaluations.
    

Intervention name(s): JNJ-77242113; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): JNJ-77242113 will be administered orally as delayed release tablets.; Matching placebo will be administered orally as delayed release tablets.
Other intervention name(s): PN-21235,; PN-235
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Metabolically Normal and Metabolically Abnormal Obesity
Condition: Obesity; Metabolic Syndrome
MeSH terms: Obesity; Metabolic Syndrome
Study type: Interventional

Summary: 
      The purpose of this study is to learn more about why some obese persons are resistant to
      developing obesity-related metabolic diseases (such as diabetes and cardiovascular disease),
      while others are prone to developing these conditions. We will do this by studying obese
      persons before and after a 5% body weight gain.

      Subjects will be asked to increase their current diet for a period of 8-12 weeks in order to
      increase their current body weight by 5%. Each will then be asked to maintain this weight
      increase for 3 weeks. We will monitor subjects throughout this time period with weekly
      medical evaluations. At the completion of the study, we will provide each subject with a
      6-month weight loss program.
    


Intervention name(s): overfeeding
Intervention type(s): Behavioral
Intervention description(s): Subjects will begin an 8-12 week high-calorie diet intervention. They will eat an additional 1000 kcal/day for two to three months, until a moderate, approximately 5% weight gain is achieved. The recommended dietary energy intake will be 1000 kcal/d more than the subject's baseline resting energy expenditure. An individualized diet plan will be developed for each subject by the study dietitian based on estimated energy requirements, and the subject's food preferences and dietary habits.
Other intervention name(s): directed weight gain
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: obesity; metabolism; cardiovascular metabolic syndrome
Recombinant Human Superoxide Dismutase (rhSOD) and Vascular Reactivity
Condition: Inflammation
MeSH terms: Inflammation
Study type: Interventional
Phase: Phase 1

Summary: 
      Inflammation is characterised by an increased risk for cardiovascular events. Dysfunction of
      the vascular endothelium caused by oxidative stress might provide a mechanistic link. In
      acute and chronic inflammation, oxidative stress occurs when the production of reactive
      oxygen species [ROS] (including superoxide anions [O2-]) exceeds the capacity of the
      endogenous antioxidant defense systems, resulting in ROS-mediated damage. Recombinant human
      superoxide dismutase (rhSOD) has shown potent antioxidant properties in in-vitro and animal
      studies and has been tested in phase I clinical trials in humans. rhSOD could offer a
      therapeutic option for vascular dysfunction in diseases associated with increased oxidative
      stress. The investigators, therefore, want to test if the hyporesponsiveness to vasoactive
      drugs (norepinephrine, acetylcholine and glyceroltrinitrate) during acute inflammation by
      low-dose lipopolysaccharide (LPS) is due to the increased production of superoxide anions,
      which could be scavanged by the radical scavenger rhSOD.
    


Intervention name(s): LPS 2 ng/kg intravenous (IV) bolus; rhSOD 82,000 IU (8.2 mg)/min intraarterially; Norepinephrine 60, 120, 240 pmol/min intraarterially over 5 min/dose level (two times; pre-dose and +3.5 hrs); Acetylcholine 6.25, 12.5, 25 nmol/min intraarterially over 3 min/dose level (two times; pre-dose and +3.5 hrs); Glyceroltrinitrate (nitroglycerine) 4, 8, 16 nmol/min over 3 min/dose level (two times; pre-dose and +3.5 hrs)
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention MeSH terms: Norepinephrine; Nitroglycerin; Acetylcholine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Efficacy of Moxibustion Therapy With or Without Smoke for Knee Osteoarthritis
Condition: Pain
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Interventional

Summary: 
      This is a multicentre, randomised, single blinded, parallel-group design clinical trial to
      assess the effect of moxa smoke in the treatment using moxibustion for Knee Osteoarthritis.
    

Detailed description: 
      Aim: To assess the effect of moxa smoke in the treatment using moxibustion for knee
      osteoarthritis.

      Design: This is a multicentre, randomised, single blinded, parallel-group design clinical
      trial. 138 eligible participants will be randomly allocated into 2 groups (moxibustion group
      or smoke-free moxibustion group) with a 1:1 allocation ratio, and receive 12 sessions of
      moxibustion treatment over a period of 4 weeks, three sessions per week. Each session will
      last 30 minutes. The whole study period is 13 weeks, with a 1 week run in period, 4 week
      treatment phase, and 8 week follow-up phase.The participants will receive moxibustion
      treatment at three acupoints (EX-LE04,ST35,ST36). In moxa-free smoke moxibustion group,
      investigators place a purification device(Shenzhen Conyson Electronic Technology Co, Ltd,C200
      moxa smoke purification device,Shenzhen,China) at the top of the moxibustion to remove the
      moxa smoke. The primary measurement outcomes are the mean change in the global scale value of
      the Western Ontario and McMaster Universities Osteoarthritis Index(WOMAC) pain and function
      scores from baseline to 4 weeks. The secondary outcomes are the Visual Analogue Scale (VAS)
      and the patient global assessment. Investigators will assess participants at the second visit
      (before starting moxibustion treatment) and at the 2, 4, 8, and 12 week respectively after
      the baseline.
    

Intervention name(s): Moxibustion; Moxa smoke purification device
Intervention type(s): Other; Other
Intervention description(s): Moxibustion at three acupuncture point(EX-LE04,ST35,ST36).12 sessions of moxibustion treatment over a period of 4 weeks, 3 sessions per week.Each session will last 30 minutes.; Investigators place a purification device(Shenzhen Conyson Electronic Technology Co, Ltd,C200 moxa smoke purification device,Shenzhen,China) at the top of the moxibustion to remove the moxa smoke.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Moxa smoke; Moxibustion; Knee osteoarthritis