bioihbjkbjnl/mcl2 huggingface dataset:
Safety Study of a Glycogen Synthase Kinase 3 (GSK3) Inhibitor in Patients With Alzheimer´s Disease
Condition: Alzheimer´s Disease
MeSH terms: Alzheimer Disease
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of this study is to evaluate if 4 escalating doses during 20 weeks of NP031112
      are safe and tolerated in patients with Alzheimer´s disease.
    


Intervention name(s): NP031112; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): unidose sachets containing dry powder for oral suspension, once daily dosing 400 mg (4 to 20 weeks), 600 mg(4 to 16 weeks),800 mg (6 to 12 weeks), 1000 mg (6 weeks); unidose sachets containing dry powder for oral suspension, once daily dosing 400 mg (4 to 20 weeks), 600 mg(4 to 16 weeks),800 mg (6 to 12 weeks), 1000 mg (6 weeks)
Other intervention name(s): tideglusib; NP12
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: safety; GSK inhibitor; Alzheimer
CT Residual Gastric Fluid Volume
Condition: Clinical CT Abdomen/Pelvic With Oral Contrast and Sedation
Study type: Observational

Summary: 
      Hypothesis: The investigators hypothesize that more than 50% of the patients receiving
      enteric contrast material (ECM) < 2 hours of anesthesia/sedation would have residual gastric
      fluid volume (GFV) > 0.4 ml/kg. The investigators also hypothesize that measuring GFV by
      using region of interest in the CT technique is accurate compared to blind aspiration of the
      gastric contents with a syringe and a multi-orificed orogastric tube.
    

Detailed description: 
      The purpose of our study is to examine the residual gastric fluid volume when oral contrast
      is administered within 2 hours of anesthesia /sedation and to validate the accuracy of
      measuring the residual gastric volume by using region of interest in the CT image by using
      blind aspiration of the gastric contents with a syringe and a multi-orificed orogastric tube.
    

Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Participants will be recruited from the Radiology CT schedule.
      
Keywords: CT, sedation, oral contrast
Frequency of Hypoglycaemic Episodes During Treatment With Insulin Detemir in Well Controlled Subjects With Type 1 Diabetes
Condition: Diabetes; Diabetes Mellitus, Type 1
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Phase 3

Summary: 
      This trial is conducted in Africa, Europe and Oceania. The aim of this trial is to
      investigate whether insulin detemir combined with insulin aspart compared to NPH insulin
      combined with insulin aspart could reduce the frequency of hypoglycaemic episodes whilst
      maintaining the same degree of glycaemic control subjects with type 1 diabetes.
    


Intervention name(s): insulin detemir; insulin NPH; insulin aspart
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Subjects were dosed according to individual requirements. Injected subcutaneously (s.c. under the skin) twice daily in the morning and at bedtime for 10 weeks after an initial 6-week titration in treatment period 1 followed by 10 weeks after an initial 6-week titration in treatment period 2; Subjects were dosed according to individual requirements. Injected subcutaneously (s.c. under the skin) twice daily in the morning and at bedtime for 10 weeks after an initial 6-week titration in treatment period 1 followed by 10 weeks after an initial 6-week titration in treatment period 2; Subjects were dosed according to individual requirements. Injected subcutaneously (s.c. under the skin) twice daily before meals for 10 weeks after an initial 6-week titration in treatment period 1 followed by 10 weeks after an initial 6-week titration in treatment period 2
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Insulin Aspart; Insulin Detemir; Isophane Insulin, Human; Insulin, Isophane; Isophane insulin, beef
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Preoperative PPI in Sleeve Gastrectomy
Condition: Morbid Obesity
MeSH terms: Obesity, Morbid
Study type: Interventional
Phase: Phase 2

Summary: 
      he purpose of this study is to study the effect of preoperative PPI in the early outcome of
      sleeve gastrectomy
    

Detailed description: 
      In this study 200 morbidly obese patients will be included and will be undergone sleeve
      gastrectomy. the patients will be randomly assigned into 2 groups, group 1 will be receive
      PPI preoperative for 10 day and group 2 will not
    

Intervention name(s): sleeve + preoperative PPI; sleeve + preoperative Placebo
Intervention type(s): Combination Product; Combination Product
Intervention description(s): sleeve + preoperative PPI; sleeve + preoperative Placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
A Study to Evaluate the Efficacy and Safety of MLTA3698A in Combination With a Disease-Modifying Anti-Rheumatic Drug (DMARD) Compared With Adalimumab in Combination With a DMARD in Patients With Active Rheumatoid Arthritis
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a Phase II, randomized, double-blind, placebo-controlled, parallel-group, multicenter
      study enrolling patients with active rheumatoid arthritis (RA).
    


Intervention name(s): MLTA3698A; adalimumab; leflunomide; methotrexate; placebo
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): Subcutaneous repeating dose; Subcutaneous repeating dose; Stable dose if not on methotrexate; Stable dose if not on leflunomide; Subcutaneous repeating dose
Intervention MeSH terms: Adalimumab; Methotrexate; Leflunomide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
A Single Dose Study of LY2605541 in Participants With Liver Impairment
Condition: Healthy Volunteers; Hepatic Insufficiency; Diabetes Mellitus, Type 2
MeSH terms: Hepatic Insufficiency; Liver Failure; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary purpose of this study is to help answer the following research questions:

        -  To evaluate how much of the study drug (LY2605541) is in the blood of participants with
           varying degrees of liver impairment compared to those with normal liver function

        -  To assess the safety of LY2605541 and any side effects that might be associated with it
    

Detailed description: 
      The study is conducted in 4 groups, based on the Child-Pugh classification of hepatic
      impairment as follows:

      Group 1: Participants with normal hepatic function (Control); Group 2: Participants with mild
      hepatic impairment (Child-Pugh class A); Group 3: Participants with moderate hepatic
      impairment (Child-Pugh class B); and Group 4: Participants with severe hepatic impairment
      (Child-Pugh class C).
    

Intervention name(s): LY2605541
Intervention type(s): Drug
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Pilot Study of Eicosapentaenoic Acid (EPA) in Patients With Cancer Cachexia
Condition: Cancer Cachexia
MeSH terms: Wasting Syndrome; Cachexia
Study type: Interventional

Summary: 
      The data collected through this pilot study will allow us to increase our understanding of
      cancer cachexia and the effect of Eicosapentaenoic Acid (EPA) on cancer cachexia. Our
      long-term goal is to improve nutritional treatment and reduce illness in the cancer patient
      population.
    

Detailed description: 
      People who have cancer can get what is called cancer cachexia (CC). The symptoms of CC
      include getting full quickly when eating (early satiety), loss of appetite, weakness
      resulting in weight loss and loss of lean body mass. Even a weight loss of 5% in cancer
      patients reflects poor health, hospitalization, and a higher rate of illness. Research shows
      that the elderly are at higher risk for deficiency of vitamins and trace minerals. Other
      pre-existing chronic diseases and drug therapies in this population may increase the needs of
      certain nutrients. Recent studies have also shown that advanced malnutrition is much more
      difficult to treat in the elderly than in younger adults, and the consequences of failure to
      treat it delays recovery and can decrease function and quality of life. At this time, the
      ways to treat CC include giving medications to increase appetite and giving nutritional
      supplements that are high in calories and protein.

      Recent studies have shown that certain types of fats that are present in fish, walnuts and
      other foods that we eat called Eicosapentaenoic acid (EPA) may help with weight gain,
      especially gain in muscle and improve quality of life in patients with pancreatic cancer.
      However, EPA has never been studied in prevention of cancer cachexia in cancer patients
      showing early signs of weight loss. Based on these early, small studies, it is clear that we
      need to study if and how EPA can prevent loss of muscle and weight in cancer patients and
      prevent this from becoming worse.
    

Intervention name(s): Eicosapentaenoic Acid
Intervention type(s): Drug
Intervention description(s): Participants will receive Lovaza at a dose of 4 g for 6 weeks. Participants will be examined at six weeks for change in protein status as indicated by change in morphological (Height, weight, body mass index, body composition, lean body mass, body fat %), and biochemical (serum prealbumin) markers of protein status and immunological cytokines (Il-6, TNF- α) markers implicated in cancer cachexia. At baseline, 3 and 6 weeks, participants will undergo interviews and laboratory analysis for determining compliance and treatment-related toxicity.
Other intervention name(s): Lovaza; EPA; omega-3-acid ethyl esters; docosahexaenoic acid; DHA
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: n-3 fatty acids; nutritional treatment; molecular pathogenesis
Effect of Interscalene and Suprascapular Nerve Block on Analgesia Consumption After Adhesive Capsulitis Surgery
Condition: Shoulder Surgery
MeSH terms: Bursitis
Study type: Interventional

Summary: 
      In this study, a combination of different types of blocks for adhesive capsulitis surgery,
      the investigators will investigate the impact on patient satisfaction and analgesic
      consumption after surgery.
    

Detailed description: 
      General anesthesia will be performed in all patients for arthroscopic adhesive capsulitis
      shoulder surgeries. In the first group of patients (Group IPSB), interscalene brachial plexus
      block will be applied 30 minutes before surgery, while interscalene brachial plexus block and
      suprascapular nerve block (SSNB) administration to the second group patients (Group SSNB)
      before surgery. Patients in the third group (Group C) will be considered the control group
      and no block will be performed. Patient-controlled analgesia (PCA) with morphine will be used
      in all three groups for postoperative analgesia. Preoperative hemodynamic data of patients,
      postoperative pain scores (VAS), morphine consumption, patient satisfaction score,
      requirement of additional analgesia and observed side effects were recorded. Consumption of
      analgesia 24 hours after surgery and patient satisfaction will be evaluated.
    

Intervention name(s): interscalene brachial plexus block; suprascapular nerve block; Group Control
Intervention type(s): Procedure; Procedure; Procedure
Intervention description(s): Single shot ultrasound guided interscalene brachial plexus block will be performed preoperatively to patients.Patient-controlled analgesia (PCA) with morphine will be used for postoperative analgesia.; Single shot ultrasound guided interscalene brachial plexus block and Suprascapular nerve block will be performed preoperatively to patients.Patient-controlled analgesia (PCA) with morphine will be used for postoperative analgesia.; consist of the patient group without any procedure.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: suprascapular nerve block; interscalene brachial plexus block; ultrasound; patient satisfaction score; analgesic consumption
A Study of ABT-888 in Combination With Carboplatin and Gemcitabine in Subjects With Advanced Solid Tumors
Condition: Advanced Solid Tumors
MeSH terms: Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine the maximum tolerated dose of veliparib
      (ABT-888)and to establish the recommended Phase 2 dose of veliparib (ABT-888) when
      administered in combination with carboplatin and gemcitabine in subjects with advanced solid
      tumors.
    


Intervention name(s): veliparib (ABT-888); carboplatin; gemcitabine
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Dosing orally twice daily starting Cycle 2 Day 1- through 21 adjusted for subsequent cohorts using a continuous reassessment method.; Carboplatin will be dosed on Day 1 of each cycle, intravenously.; Dosing on Days 1 and 8 of each Cycle, intravenously.
Other intervention name(s): Gemzar
Intervention MeSH terms: Carboplatin; Gemcitabine; Veliparib
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: PARP Inhibitors
Placebo-Controlled Crossover Study for the Investigation of the Effect of Pantoprazole on Cardiac Contractility
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      Recently, negative inotropy of pantoprazole has been shown in isolated human myocardium. This
      study was designed to test the clinical relevance of this finding in healthy volunteers by
      measuring left ventricular function during infusion of a common intravenous high dose regimen
      of pantoprazole.
    

Detailed description: 
      Purpose: Reports on cardiac problems with oral proton pump inhibitors have caused extensive
      safety reviews by the U.S. Food and Drug Administration. We provide additional data on acute
      cardiac effects of an intravenous application.

      Methods: Echocardiography was performed in 18 healthy volunteers after administration of a
      common high dose regimen of pantoprazole (80 mg IV bolus followed by 8 mg/h for 1h) or
      placebo. Design: Randomized, double-blind, placebo-controlled crossover trial.

      Results: EF [%, means+/-S.E.] in the treatment group (placebo group) was 60.7+/-1.1
      (61.2+/-1.7) at baseline, and 62.6+/-1.1 (62.1+/-1.9), 64.7+/-1.6 (63.5+/-1.3), 62.6+/-1.6
      (61.0+/-1.6) and 63.0+/-1.4 (61.8+/-1.5) at 7.5, 15, 30 and 60 min after bolus application,
      respectively (p = n.s.). Similarly, no significant changes were found for cardiac output,
      cardiac index, blood pressure, and heart rate. In contrast, gastric pH that was used as a
      treatment control was significantly increased 60 min after application of pantoprazole as
      compared to baseline and to placebo.

      Conclusions: Pantoprazole for injection is safe in healthy subjects with respect to cardiac
      contractile function. However, in view of recent reports of negative inotropy of the drug
      further studies in heart failure patients are required.
    

Intervention name(s): Pantoprazole; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 80 mg IV over 2 minutes, followed by 8 mg/h IV for 60 minutes; Identical infusion manner like experimental arm
Other intervention name(s): Pantozol i.v.; Protonix I.V.; NaCl 0.9%
Intervention MeSH terms: Pantoprazole
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: Proton Pump Inhibitors; pantoprazole; Cardiac Output; Echocardiography; adverse effects
the Safety, Tolerability, and Pharmacokinetics Study of HEC113995
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depressive Disorder, Major
Study type: Interventional
Phase: Phase 1

Summary: 
      Multiple Dose Safety, Tolerability, PK and Food Effect Study of HEC113995 PA•H2O in Healthy
      Subjects
    


Intervention name(s): Food; HEC113995; placebo
Intervention type(s): Other; Drug; Drug
Intervention description(s): HEC113995 20mg will be taken orally fasted or with food; HEC113995 will be taken orally fasted (HEC113995 10mg）or with food (HEC113995 20mg and 40mg） for 10 days; The placebo will be administered fasted or with food for 10 days.
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
A Study of the Safety and Efficacy of Topiramate in the Treatment of Obese, Type 2 Diabetes Patients on a Controlled Diet
Condition: Obesity; Diabetes Mellitus, Type 2; Diabetes Mellitus, Adult-Onset
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to determine the efficacy and safety of topiramate compared with
      placebo in obese, Type 2 diabetic patients on a controlled diet.
    

Detailed description: 
      Topiramate is not approved for the treatment of obesity. This is a randomized, double-blind,
      placebo-controlled study to evaluate the efficacy and safety of topiramate in obese,
      diet-controlled, type 2 diabetic patients. Patients are randomized to receive either
      topiramate or placebo. After a 5 week pre-enrollment phase followed by a 6 week run-in phase,
      patients in the topiramate group start an 8-week titration phase to reach the assigned dose
      of topiramate, either 96 or 192 mg daily. Treatment continues for 1 year. Assessments of
      effectiveness include percent change in body weight, hemoglobin type A1c [HbA1c] levels, Body
      Mass Index [BMI], the numbers and proportion of 5% and 10% weight loss responders, glucose
      tolerance, waist and hip circumferences, changes in the mass of left ventricle of the heart,
      blood pressures, and fasting lipid profiles. Safety evaluations, including incidence of
      adverse events, vital signs, clinical laboratory values, and electrocardiograms [ECGs], are
      monitored throughout the study. The study hypothesis is that topiramate, combined with
      controlled diet, will be effective in weight reduction and controlling blood sugar level and
      is well tolerated. During the initial 8 weeks, the oral doses of either a matching placebo or
      topiramate will be gradually increased to the target doses (96 milligrams[mg] or 192mg
      daily); the dose will be maintained for 1 year.
    

Intervention name(s): topiramate
Intervention type(s): Drug
Intervention MeSH terms: Topiramate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Type 2 Diabetes Mellitus; Obesity; Diabetic Diet; Hypertension; Hyperlipidemia; Adult-Onset Diabetes Mellitus(AODM)
Effects of a Mulligan Mobilisation in the Lumbar Flexion Range of Asymptomatic Subjects
Condition: Low Back Pain
MeSH terms: Back Pain; Low Back Pain
Study type: Interventional

Summary: 
      Mulligan's mobilisation techniques are believed to increase the range of movement (ROM) in
      patients with low back pain. The primary aim of this study was to investigate the mechanical
      effects of Mulligan's "SNAG" technique on lumbar flexion ROM. The secondary aim was to
      measure the intra- and inter-day reliability of lumbar ROM employing the same procedure, and
      utilising a 3-D motion analysis system for measuring range of motion (ROM).
    

Detailed description: 
      The primary aim of this study was to investigate the mechanical effects of Mulligan's "SNAG"
      technique on lumbar flexion ROM. The secondary aim was to measure the intra- and inter-day
      reliability of lumbar ROM employing the same procedure. For the interventional component of
      the study, 49 asymptomatic volunteers participated in it. Subjects were randomly assigned
      into either a treatment (SNAG) group (n=25), or a placebo (SHAM) group (n=24). The "SNAG"
      technique was applied on L3 and L4 spinal levels by an experienced manual therapist. SNAGs
      were performed with active flexion in sitting, 10 times at each level. The placebo-SHAM was
      similar to the SNAG without however applying the appropriate direction or force. Lumbar ROM
      was measured by a three dimensional electronic goniometer (Zebris CM20), before and after
      each technique. For the reliability component, five measurements in two different days (one
      week apart) were performed in 20 healthy subjects.
    

Intervention name(s): Application of the SNAG technique
Intervention type(s): Other
Intervention description(s): SNAG is a painless and gentle manual technique, mimicking a slide with concurrent active movement, performed in the lumbar spine (in this study) by an experienced manual therapist-physiotherapist.
Other intervention name(s): Sustained Natural Apophyseal Glide; Mulligan mobilisation
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Low back pain; Manual therapy; Mulligan snag
Effect of Arthrospira Platensis (Spirulina) as an Adjunct to Scaling and Root Planing on Salivary Antioxidant Levels in Chronic Periodontitis Subjects
Condition: Chronic Periodontitis
MeSH terms: Periodontitis; Chronic Periodontitis
Study type: Interventional
Phase: Phase 4

Summary: 
      Introduction- Oxidative stress plays a causative role in pathogenesis of periodontal disease.

      It has been reported that Spirulina platensis or its active ingredient C phycocyanin (CPC)
      exerts anti-inflammatory, anti-oxidative and inhibitory effects on prostaglandin and
      leukotriene biosynthesis.

      Aim- To evaluate the effect of dietary spirulina as an adjunct to SRP on salivary
      antioxidants level in CP subjects.

      Materials And Methods- The study was a randomized double-blind clinical and biochemical trial
      in which 70 subjects with CP in the age group of 40-55 years, reporting to Department of
      Periodontology, TKDC and RC, New Pargaon, were equally and randomly divided into Test Group
      (TG) and Control Group (CG). TG was given 2 gm Spirulina capsules daily, after meals for 1
      month and CG was not given any supplementary diet. SRP was done at baseline in TG and CG.
      Whole saliva sample was collected. Clinical and biochemical parameters will be recorded at
      baseline, 1 month & 3 months.
    


Intervention name(s): Spirulina capsules
Intervention type(s): Drug
Intervention description(s): Spirulina capsules 2gm daily for 1 month
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment