bioihbjkbjnl/mcl2 huggingface dataset:
Esketamine Administration on Recovery Quality After Radical Mastectomy
Condition: Esketamine and the Quality of Recovery
Study type: Interventional

Summary: 
      Some studies have reported that intravenous esketamine reduce postoperative pain intensity.
      The investigators investigated whether esketamine could improve the the quality of recovery
      after modified radical mastectomy.
    

Detailed description: 
      A total of 111 patients were randomly allocated into 3 groups. Patients in group LE received
      a bolus infusion of esketamine (0.5 mg/kg) before cutting the skin, and then esketamine was
      infused at a rate of 2 µg/kg/min until before suture the skin. Patients in group HE received
      a bolus infusion of esketamine (0.5 mg/kg) before cutting the skin, and then esketamine was
      infused at a rate of 4 µg/kg/min until before suture the skin. Patients in group CON received
      a bolus infusion of the same volume saline before cutting the skin, and then the same volume
      saline was infused until before suture the skin.
    

Intervention name(s): Low-dose esketamine infusion; High-dose esketamine infusion; Saline infusion
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Patients received a bolus infusion of esketamine (0.5 mg/kg) before cutting the skin, and then esketamine was infused at a rate of 2 µg/kg/min until before suture the skin.; Patients received a bolus infusion of esketamine (0.5 mg/kg) before cutting the skin, and then esketamine was infused at a rate of 4 µg/kg/min until before suture the skin.; Patients received a bolus infusion of the same volume saline before cutting the skin, and then the same volume saline was infused until before suture the skin.
Intervention MeSH terms: Esketamine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Esketamine; The quality of recovery
Improvement Of Physical And Physiological Parameters In Menopausal Or Post-Menopausal Celiac Women
Condition: Celiac Disease; Diet, Gluten-Free; Exercise; Resistance Training; Quality of Life; Body Composition
MeSH terms: Celiac Disease
Study type: Interventional

Summary: 
      Celiac disease (CD) is an immunological disorder that mainly affects the small intestine,
      generating an inflammatory process in response to the presence of gluten (a protein).
      Autoimmune diseases are part of a group of diseases that are difficult to diagnose without a
      specific protocol or consensus to detect them due to the number of symptoms and diseases with
      which it has a relationship. The incidence of CD in Spain -according to data from the rest of
      the European Economic Community, since there is no study on incidence in Spain- is assumed to
      be approximately 1 per 100 live births. It is more frequent in women, with a 2:1 ratio. The
      only treatment consists of a STRICT GLUTEN-FREE DIET FOR LIFE. This results in the
      disappearance of symptoms, normalization of serology and recovery of intestinal villi.
      Failure to follow the diet can lead to important complications which, especially in
      adulthood, can manifest themselves in the form of osteopenia, osteoporosis and a high risk of
      neoplasms in the digestive tract, mainly. The main objective is to achieve a physical and
      physiological improvement in menopausal or post-menopausal celiac women. The specific
      objectives will be to know the influence of a dietary-nutritional program combined with
      physical exercise in menopausal or post-menopausal celiac women on:

        -  Physical condition (strength, endurance, functional autonomy...).

        -  Body composition.

        -  Psychological aspects.

        -  Physiological parameters (heart rate, maximum oxygen consumption, blood analysis...).
    


Intervention name(s): Gluten-free nutrition plan + exercise group; Gluten-free nutrition plan group; Active Comparator: Celiac controls group
Intervention type(s): Behavioral; Behavioral; Behavioral
Intervention description(s): Menopausal or post-menopausal celiac women will follow a physical exercise program 3/4 times per week and their dietary intake will be gluten-free isocaloric; Menopausal or post-menopausal celiac women will follow a gluten-free isocaloric dietary program; Menopausal or post-menopausal celiac women in whom all the tests were measured but they did not perform an intervention program with physical exercise or special follow-up of an adapted dietary-nutritional program
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Alkontrol-herbal Effects on Alcohol Drinking
Condition: Alcohol Drinking; Alcohol Use Disorder; Alcohol Abstinence
MeSH terms: Alcoholism; Alcohol Drinking; Alcohol Abstinence
Study type: Interventional
Phase: Phase 2

Summary: 
      Participants will enroll in a 14-week study (2 weeks of baseline, 8 weeks of treatment, and 4
      weeks of follow-up) investigating the impact that Alkontrol-herbal (Isoflavone; Kudzu) has on
      alcohol intake in a population seeking treatment for an alcohol use disorder.
    

Detailed description: 
      Over the past 15 years, the Behavioral Psychopharmacology Research Lab at McLean Hospital has
      extensively studied kudzu extract and demonstrated its safety and efficacy in healthy control
      subjects as well as in heavy binge drinkers. The relative success of our recent outpatient
      trial of kudzu extract demonstrated a modest decrease in drinking, reduction in the number of
      heavy drinking days, and significant increase in the number of days abstinent. This suggests
      that Alkontrol-herbal, kudzu extract, may be a useful adjunct in treating alcohol use
      disorders.

      Participants will enroll in a 14-week study (2 weeks of baseline, 8 weeks of treatment, and 4
      weeks of follow-up) investigating the impact that Alkontrol-herbal has on alcohol intake in a
      population (age 21-60 years) seeking treatment for an alcohol use disorder. Participants will
      take 500 mg of a crude kudzu extract (NPI-031, Alkontrol-herbal; Natural Pharmacia
      International, Burlington, MA) t.i.d.; matched sugar beet placebo capsules will serve as
      placebo. Subjects will come to the lab three times a week to provide urine samples that can
      be tested for medication compliance through a biochemical marker, acetazolamide, included in
      the medication capsules. Participants will record their alcohol intake through daily diaries
      and a wrist actigraphy device, which will also monitor their sleep/wake activity.
    

Intervention name(s): kudzu extract, puerarin; Placebo control
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Capsules containing 500 mg of a crude kudzu extract (NPI-031, Alkontrol-herbal; Natural Pharmacia International, Burlington, MA) will be used, containing 19% puerarin, 4% daidzin and 2% daidzein, so each capsule contains a total of 25% active isoflavones or 125 mg.; Matched sugar beet placebo capsules will serve as placebo.
Other intervention name(s): Alkontrol-herbal
Intervention MeSH terms: Puerarin
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Half of the enrolled subjects will receive treatment with Alkontrol-herbal, kudzu extract, and half will receive a placebo control.
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment
AMISH : Aprovel for Management of Isolated Systolic Hypertension
Condition: Hypertension
MeSH terms: Hypertension; Isolated Systolic Hypertension
Study type: Interventional
Phase: Phase 4

Summary: 
      To compare the antihypertensive efficacy and tolerability of irbesartan and
      irbesartan-hydrochlorothiazide fixed combination therapy with amlodipine and amlodipine plus
      hydrochlorothiazide in the treatment of isolated systolic hypertension.
    


Intervention name(s): irbesartan and irbesartan-hydrochlorothiazide
Intervention type(s): Drug
Intervention MeSH terms: Hydrochlorothiazide; Irbesartan
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
The Effects of External Cues Versus Internal Cues Messaging on Heart Rate Variability and Affect
Condition: Dietetics; Diet, Healthy; Nutrition Therapy; Affect; Autonomic Nervous System
Study type: Interventional

Summary: 
      This randomized controlled trial will assess the effects of External Cues focused messaging
      (i.e., government recommendations of MyPlate) compared to Internal Cues focused messaging
      (i.e., intuitive eating). The investigators will collect data on within-person changes in
      psychological (e.g. affect) and physiological (e.g. heart rate variability) outcomes in
      female college students.

      Participants will be randomly assigned to one of two study conditions. In condition one,
      participants will view a five-minute video focusing on traditional nutrition education
      principles. In condition two, participants will view a five-minute video focusing on
      intuitive eating principles.
    


Intervention name(s): Internal Cues Nutrition Messaging; External Cues Nutrition Messaging
Intervention type(s): Other; Other
Intervention description(s): Participants will view a 5 minute nutrition education video focused on intuitive eating principles.; Participants will view a 5 minute nutrition education video focused on traditional nutrition education principles such as label reading.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Participants attend a single study visit and are randomized to view one of two nutrition education videos.
Masking: Single (Participant)
Primary purpose: Basic Science
Keywords: nutrition messaging; nutrition education; Intuitive Eating
Iron Supplementation for Acute Anemia After Postbariatric Abdominoplasty
Condition: Anemia, Iron-Deficiency; Weight Loss
MeSH terms: Anemia; Anemia, Iron-Deficiency; Iron Deficiencies; Weight Loss
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to determine whether intravenous or oral iron are effective in
      the treatment of postoperative anemia and iron deficiency in patients submitted in
      postbariatric abdominoplasty.
    

Detailed description: 
      Multicenter open randomized clinical trial with allocation ratio 1: 1. 56 adult patients
      undergoing post- bariatric abdominoplasty will be evaluated. The study group will receive 200
      mg of intravenous iron in the immediate postoperative period and a second application on day
      1 postoperatively. The control group will receive 100 mg of oral iron twice daily for 8
      weeks. Haematological variables , iron 's profile , quality of life ( SF -36 and FACT- An)
      and adverse events will be assessed preoperatively and on the first , fourth and eighth weeks
      postoperatively .
    

Intervention name(s): Intravenous Iron sucrose; Oral Iron
Intervention type(s): Drug; Drug
Intervention description(s): Intravenous Iron Sucrose 200 mg in the immediate postoperative period and first day postop.; Oral iron(III)-hydroxide polymaltose complex 100 mg twice daily in the fist 8 postoperative weeks.
Other intervention name(s): Noripurum; Noripurum
Intervention MeSH terms: Iron; Ferric Oxide, Saccharated; Teferrol; Ferric Compounds
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Anemia, Iron-Deficiency; bariatric surgery; abdominoplasty; surgery, plastic; iron
Differences in Morbidity Between a Necessity Endotracheal Suctioning Protocol Versus a Routine Endotracheal Suctioning
Condition: Hypoxemia; Arrhythmias; Cardiac Arrest; Ventilator Associated Pneumonia
MeSH terms: Pneumonia, Ventilator-Associated; Hypoxia
Study type: Interventional

Summary: 
      Morbidity frequency associated to a endotracheal suctioning is different between a necessity
      endotracheal suctioning protocol versus a routine endotracheal protocol.
    

Detailed description: 
      Endotracheal aspiration is a very useful procedure. It has several adverse events every time
      that aspiration is practiced. This trials wants to identify which protocol (necessity versus
      routine) could be better to practice in pediatrics intensive care unit with less risk.
    

Intervention name(s): Necessity endotracheal suctioning; Routine endotracheal suctioning
Intervention type(s): Procedure; Procedure
Intervention description(s): Endotracheal suctioning depends on clinical manifestations; Endotracheal suctioning every two hours
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Unplanned extubation; Length of stay in PICU; Length of mechanical ventilation
Mobilaser Study to Help With People Who Are Having Problems With Their Gait
Condition: Parkinson's Disease; Parkinsonism
MeSH terms: Parkinson Disease; Parkinsonian Disorders
Study type: Interventional
Phase: Early Phase 1

Summary: 
      Does use of the Mobilaser reduce freezing of gait (FOG) and stride reduction in patients with
      Parkinson's disease and Parkinsonism.
    

Detailed description: 
      Can patients walk faster and have less freezing when using the mobilaser then when not using
      it
    

Intervention name(s): Mobilaser
Intervention type(s): Device
Intervention description(s): Patients will begin by collecting data at home without using the mobilaser. They will then be given the mobilaser to use at home for 6 weeks while they collect data on whether their gait has improved. They will then have to return the Mobilaser to the clinic and collect data at home for 3 days to see if there is a difference.
Other intervention name(s): Laser; Walker with laser
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Parkinson's disease; Parkinsonism; Gait problems; Freezing gait
Peripherical Neuromuscular Electrical Stimulation in Systemic Autoimmune Myopathies
Condition: Electrical Remodeling; Rheumatic Diseases; Myopathy
MeSH terms: Rheumatic Diseases; Muscular Diseases; Collagen Diseases; Atrial Remodeling
Study type: Interventional

Summary: 
      Systemic autoimmune myopathies are a heterogeneous group of rheumatic diseases with
      progressive skeletal muscle weakness. The relevance of the peripherical neuromuscular
      electrical stimulation has never applied in the patients with systemic autoimmune myopathies.
      Therefore, the main objective of the present prospective, randomized, investigator-blind,
      placebo-controlled study is to evaluate the safety and efficacy of the application of an
      acute peripherical neuromuscular electrical stimulation session in patients with systemic
      autoimmune myopathies.
    

Detailed description: 
      Systemic autoimmune myopathies are a heterogeneous group of rheumatic diseases that primarily
      affect the skeletal muscles. Despite these advances, this group of diseases still continues
      to be associated with high morbidity and functional disability, mainly due to the proximal
      muscular weakness of the scapular and pelvic girdles that may prevent the total recovery of
      these patients. On the other hand, the importance of the peripherical neuromuscular
      electrical stimulation has never applied in the patients with systemic autoimmune myopathies.
      Therefore, the main objective of the present prospective, randomized, investigator-blind,
      placebo-controlled study is to evaluate the safety and efficacy of the application of an
      acute peripherical neuromuscular electrical stimulation session in patients with systemic
      autoimmune myopathies.
    

Intervention name(s): Electrical stimulation
Intervention type(s): Other
Intervention description(s): Patients with systemic autoimmune myopathies will receive peripheral electrical stimulation in thigh muscles
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Patients with systemic autoimmune myopathies will receive or not the periphericalneuromuscular electrical stimulation in thigh muscles
Masking: Single (Investigator)
Primary purpose: Other
Keywords: systemic autoimmune myopathies; Peripherical neuromuscular electrical stimulation; myositis
Hepatic and Cardiac Metabolic Flexibility in Subjects With T2DM With and Without NAFLD
Condition: NAFLD - Non-Alcoholic Fatty Liver Disease; Type 2 Diabetes
MeSH terms: Liver Diseases; Fatty Liver; Non-alcoholic Fatty Liver Disease; Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      Non-alcoholic fatty liver disease (NAFLD) covers a spectrum from simple reversible hepatic
      steatosis to inflammation and fibrosis termed steatohepatitis (NASH) and cirrhosis.
      Accumulating evidence indicates that NAFLD is associated with development of heart failure,
      abnormal ventricular glucose and fatty acid (FA) utilisation and cardiac steatosis. The
      mechanisms behind why some subjects progress from NAFLD to NASH and the link between cardiac
      involvement and NAFLD are poorly understood, but must include altered cardiac and
      intrahepatic lipid handling. Investigators plan comprehensive kinetic studies of heart and
      liver FA uptake and oxidation, ventricular function and substrate utilisation, and hepatic
      triglyceride (TG) secretion in order to assess mechanisms governing cardiac and hepatic lipid
      and glucose trafficking in subjects with type 2 diabetes with and without NAFLD and NASH and
      the relationship with heart function. In addition, the investigators will assess skeletal
      muscle and adipose tissue enzyme activities, gene expression and protein concentrations in
      type 2 diabetic subjects to define mechanisms involved in the cross-talk between heart,
      liver, muscle and adipose tissues. Investigators will address these questions using tracer
      techniques (11Cpalmitate PET tracers and triglyceride (TG) tracers) to study cardiac and
      liver substrate trafficking, as well as MR spectroscopy, echocardiography, muscle and fat
      biopsies in combination with state-of-the art muscle and adipose tissue enzyme kinetics,
      gene- and protein expression. The overarching goals are to define abnormalities and
      differences between NAFLD and NASH in hepatic lipid (FA and TG) metabolism.
    


Intervention name(s): Hyperinsulinemic euglycaemic clamp
Intervention type(s): Other
Intervention description(s): Infusion of constant intravenous insulin to achieve hyperinsulinemia and concomitant infusion of glucose to maintain euglycemia (plasma glucose at 5 mM).
Infusion of palmitate and VLDL-triglyceride tracer. PET/CT scans of heart and liver, both in basal period and during intervention.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Safety and Pharmacokinetic Evaluation of Nitrite for Prevention of Cerebral Vasospasm
Condition: Subarachnoid Hemorrhage
MeSH terms: Subarachnoid Hemorrhage; Hemorrhage
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of the study is to examine the safety of a 14 day infusion of sodium nitrite, and
      to study the pharmacokinetics of nitrite, during a 14 day infusion in patients with ruptured
      cerebral aneurysms.
    

Detailed description: 
      Intravenous sodium nitrite has been shown to prevent and to reverse cerebral vasospasm in a
      primate model of subarachnoid hemorrhage (SAH). This was a Phase IIA dose escalation study of
      sodium nitrite to determine its safety in patients with aneurysmal SAH and to establish its
      pharmacokinetics during a 14 day infusion.

      Sodium nitrite was delivered intravenously for 14 days in 18 patients with SAH from a
      ruptured cerebral aneurysm using a dose escalation scheme in three cohorts of 6 patients each
      (3 nitrite, 3 saline), with a maximum dose of 64 nmol/min/kg. Sodium nitrite blood levels
      were frequently sampled and measured using mass spectroscopy and blood methemoglobin levels
      were continuously monitored using a pulse oximeter.
    

Intervention name(s): Sodium nitrite; Saline
Intervention type(s): Drug; Drug
Intervention description(s): 14 day continuous infusion of one of 3 escalating doses of sodium nitrite: 32 nmol/min/kg, 48 nmol/min/kg, or 64 nmol/min/kg; 14 day continuous infusion of a vehicle control infusion
Other intervention name(s): Sodium Nitrite Injection NDC 60267-311-10; Sterile saline
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Cerebral aneurysm; Subarachnoid hemorrhage; Nitrite
DynamX Sirolimus Study Sirolimus Eluting Coronary Bioadaptor System
Condition: Coronary Artery Disease
MeSH terms: Coronary Artery Disease
Study type: Interventional

Summary: 
      To confirm the safety and performance of the DynamX Sirolimus-eluting Coronary Bioadaptor
      System (SECBS) in de novo native coronary artery lesions using clinical and imaging
      endpoints. Clinical follow-up will be conducted in all patients at 30 days, 6 and 12 months.
      Imaging follow-up will be conducted at 6 months.
    

Detailed description: 
      The DynamX Sirolimus Study is a prospective, consecutive enrollment, single-arm study
      designed to enroll up to 30 patients requiring treatment of up to two de novo lesions ≤ 24 mm
      in length in vessels ≥ 2.5 mm and ≤ 3.5 mm in diameter.

      One or two designated target lesions, located in separate epicardial vessels (RCA, LCX or
      LAD), and meeting the inclusion/exclusion criteria may be treated with the DynamX SECBS.
      Alternatively, one target lesion may be treated with the DynamX SECBS after successful,
      uncomplicated treatment of a non-target lesion, located in a separate epicardial vessel, with
      any commercially-available DES. Acceptable example: non-target RCA lesion and LAD target
      lesion. Not acceptable example: LAD non-target lesion and 1st diagonal target lesion.

      The primary safety endpoint is Target Lesion Failure at 6 months. TLF is a composite endpoint
      defined as cardiac death, target vessel MI, and clinically-indicated target lesion
      revascularization The primary efficacy endpoint is late lumen loss at 6 months, assessed by
      angiography Additional secondary safety and effectiveness endpoints will be evaluated at 30
      days, 6 and 12 months Using visual assessment, the target lesion must measure ≥ 2.5 mm and ≤
      3.5 mm in diameter and ≤ 24 mm in length able to be covered by a single DynamX Sirolimus
      Bioadaptor including 2 mm of healthy vessel on either side of the planned treatment area.

      The patient will be eligible for stent (also called bioadaptor) implantation only after
      satisfactory lesion pre-dilatation defined as: ≥ TIMI 2 flow, and no dissection greater than
      Grade B (NHLBI) able to be covered with a single DynamX SECBS
    

Intervention name(s): DynamX Sirolimus-eluting Coronary Bioadaptor System
Intervention type(s): Device
Intervention description(s): de novo native coronary artery lesions
Intervention MeSH terms: Sirolimus
Intervention model: Single Group Assignment
Intervention model description: prospective, consecutive enrollment, single-arm study
Masking: None (Open Label)
Primary purpose: Treatment