bioihbjkbjnl/mcl2 huggingface dataset:
Clinical Trial on the Effect of the Sublimated Mare Milk Supplement on Primary Biliary Cholangitis
Condition: Primary Biliary Cirrhosis
MeSH terms: Cholangitis; Liver Cirrhosis, Biliary; Fibrosis
Study type: Interventional

Summary: 
      This study evaluates the effect of sublimated mare milk supplement on patients with biliary
      cholangitis
    

Detailed description: 
      Primary biliary cholangitis, formerly known as primary biliary cirrhosis, is a rare chronic
      disease that primarily affects women. Primary biliary cholangitis often progresses to the
      terminal stage of liver cirrhosis with its inherent complications. At this stage, the only
      way to save the patient's life is liver transplantation, and is accompanied by a number of
      painful symptoms (itching, mucous dryness, abdominal discomfort, fatigue), often restless
      legs syndrome, insomnia, depression and cognitive dysfunction.

      The goal of the treatment is to prevent the terminal stage of cirrhosis of the liver and to
      alleviate the accompanying symptoms. Conventional drug therapy is aimed at slowing the
      progression of the disease and includes both approved for the use of these medications
      (ursodeoxycholic acid) and used outside the approved indications (derivatives of fibric acid,
      budesonide).

      The role of this clinical trial is to increase the effectiveness of therapy for this disease.
      Against the background of the complexity of the treatment of primary biliary cholangitis,
      clinical medicine acquires a remedy in the form of a natural product - mare's milk,
      preventive, dietary, medicinal effects of which have been known for a long time. There are
      data from studies that have shown the efficacy and safety of using mare milk in patients with
      atopic dermatitis as well as with inflammatory bowel diseases. For the liver diseases, there
      are no reported studies.

      In this trial, there will be two parallel groups: Interventional (supplement with standard
      treatment first for 3 months) and Standard treatment group. Differences in clinical,
      laboratory, liver encephalopathy and asthenia will be evaluated between groups.
    

Intervention name(s): Sublimated mare milk; Ursodeoxycholic Acid
Intervention type(s): Dietary Supplement; Drug
Intervention description(s): The dietary supplement mare milk product, which is obtained from fresh mare milk (few hours) through sublimation process.; Ursodeoxycholic acid treatment will be given for 3 months.
Intervention MeSH terms: Ursodeoxycholic Acid
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Primary Biliary Cirrhosis; Primary Biliary Cholangitis; Mare Milk
NT 201 (Xeomin®/Bocouture®) in Comparison With Clostridium Botulinum Toxin Type A in the Treatment of Glabellar Frown Lines
Condition: Glabellar Frown Lines
Study type: Interventional
Phase: Phase 3

Summary: 
      NT 201, also known as IncobotulinumtoxinA (Xeomin®/Bocouture®), is a Botulinum toxin type A
      preparation free of complexing proteins (150 kiloDalton). Injected into the muscle, NT201
      causes a reversible local relaxation of the injected muscle. Botulinum toxin type A is used
      for aesthetic treatment of mimic wrinkles and in the therapy of neurologic diseases. This
      study will investigate the safety and efficacy (non-inferiority) of NT 201 in comparison with
      OnabotulinumtoxinA (Vistabel®) in the treatment of glabellar frown lines.
    


Intervention name(s): NT 201 (IncobotulinumtoxinA (Xeomin®/Bocouture®)); OnabotulinumtoxinA (Vistabel®)
Intervention type(s): Drug; Drug
Intervention description(s): NT201, also known as IncobotulinumtoxinA (Xeomin®/Bocouture®), active ingredient: Clostridium botulinum neurotoxin type A free from complexing proteins, powder for solution for injection dose, 24 units; one injection session of solution, prepared by reconstitution of powder with 0.9% Sodium Chloride (NaCl). Of the 0.6 mL total injection volume, an aliquot of 0.15 mL was administered in the procerus muscle, aliquots of 0.125 mL were administered in the medial part of the both corrugator muscles and aliquots of 0.1 mL were administered in the middle part of both corrugator muscles.; OnabotulinumtoxinA (Vistabel®), active ingredient: Clostridium botulinum neurotoxin type A, powder for solution for injection dose, 24 units; one injection session of solution, prepared by reconstitution of powder with 0.9% Sodium Chloride (NaCl). Of the 0.6 mL total injection volume, an aliquot of 0.15 mL was administered in the procerus muscle, aliquots of 0.125 mL were administered in the medial part of the both corrugator muscles and aliquots of 0.1 mL were administered in the middle part of both corrugator muscles.
Other intervention name(s): "Botulinum toxin type A (150 kiloDalton), free from complexing proteins"; "BOTOX® Cosmetic"; "Botulinum toxin type A (900 kiloDalton)"
Intervention MeSH terms: Botulinum Toxins; Botulinum Toxins, Type A; abobotulinumtoxinA; incobotulinumtoxinA
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Study to Assess the Effect of Food on the Concentration of GW273225 in the Body of Healthy Male and Female Volunteers
Condition: Bipolar Disorder
MeSH terms: Bipolar Disorder
Study type: Interventional
Phase: Phase 1

Summary: 
      The rationale of this study is to assess whether or not food affects the absorption of
      GW273225 into the blood of healthy male and female volunteers in order to evaluate whether or
      not this drug should be given at a certain time relative to the consumption of food.
    


Intervention name(s): GW273225
Intervention type(s): Drug
Intervention description(s): GW273225 will be available as white tablets containing 25 mg GW273225.The study drug will be taken with 240 milliliters of water at room temperature.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: healthy volunteers; food effect,; quantitative pharmacokinetic analysis,; GW273225,
An Efficacy and Safety Study of Topiramate in the Treatment of Alcohol Dependence
Condition: Alcoholism
MeSH terms: Alcoholism
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the safety and effectiveness of topiramate compared
      to placebo in patients with alcohol dependence.
    

Detailed description: 
      The impact of alcoholism can be reduced through effective treatments, which may include
      medical, psychological, and social interventions. The main goals of alcohol-dependence
      treatment are to assist patients in avoiding alcohol, developing better strategies for
      managing stress, and improving self-esteem and quality of life. Studies have demonstrated
      that treatments for alcohol use disorders can be effective, but their effectiveness is often
      limited. Although the optimal goal of treatment should be total abstinence, even patients who
      are unable to achieve this goal may still benefit from treatments leading to a reduction in
      drinking. Medications are commonly used in other addictive disorders, such as nicotine and
      opioid dependence, suggesting that this intervention could be useful in the treatment of
      alcohol dependence. This is a randomized, double-blind, flexible dose study to determine if
      topiramate, a prescription medication approved by the Food & Drug Administration for the
      treatment of epilepsy and the prevention of migraine, administered at a dose of 300mg per day
      or the subject's maximum tolerated dose, is safe and effective compared with placebo in
      patients with alcohol dependence. The study hypothesis is that topiramate will be more
      effective than placebo in reducing the percentage of heavy drinking days (5 or more standard
      drinks per day for men and 4 or more standard drinks per day for women) in patients with
      alcohol dependence. The patients will receive topiramate tablets (25mg and/or 100mg) or
      matching placebo. Study medication is taken in increasing doses starting at 25 mg/day up to
      300 mg per day (or maximum tolerated dose) during the first 6 weeks and the achieved dose is
      maintained for an additional 8 weeks.
    

Intervention name(s): topiramate
Intervention type(s): Drug
Intervention MeSH terms: Topiramate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: alcoholism; alcohol dependence; medication treatment.
Neoadjuvant Chemotherapy or Chemoradiotherapy in Resectable Oesophageal Carcinoma（NewEC Study）
Condition: Radiotherapy Side Effect; Chemotherapy Effect; Oesophageal Carcinoma; Effect of Drugs; Safety Issues
MeSH terms: Carcinoma; Esophageal Neoplasms
Study type: Observational

Summary: 
      To provide comprehensive efficacy and safety profiles of neoadjuvant chemoradiotherapy (NCRT)
      versus neoadjuvant chemotherapy (NCT) versus surgery alone in resectable oesophageal
      carcinoma.
    

Detailed description: 
      Neoadjuvant chemotherapy (NCT) or neoadjuvant chemoradiotherapy (NCRT) has been shown to be
      better than surgery alone in patients with resectable oesophageal carcinoma, but higher
      quality evidence is needed as new findings have emerged regarding this issue.Previous
      evidence-based findings and the current guidelines have not established a survival advantage
      of NCRT over NCT or an acceptable safety profile of the addition of radiotherapy to NCT;
      whether NCRT or NCT is more effective for the treatment of adenocarcinoma or squamous cell
      carcinoma of the oesophagus is unclear.This study aims to provide comprehensive efficacy and
      safety profiles of NCRT versus NCT versus surgery alone in resectable oesophageal carcinoma.
    

Intervention name(s): Neoadjuvant chemoradiotherapy; Oesophagectomy; Neoadjuvant chemotherapy
Intervention type(s): Combination Product; Procedure; Drug
Intervention description(s): In most patients, the chemotherapy regimens before surgery were consisted of cisplatin combined with either fluorouracil or taxanes.; Various surgical oesophagectomy methods were used, such as Ivor Lewis, transthoracic, three-hole, transhiatal, and left transthoracic,and the appropriate surgical approach for each patient was chosen according to the tumour location, size, and depth.; In most patients, the chemotherapy regimens before surgery were consisted of cisplatin combined with either fluorouracil or taxanes.
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Patients with histologically documented untreated SCC or adenocarcinoma of the oesophagus
        or gastro-oesophageal junction that was clinically staged as stage I-III (T1-3, N0-1 and
        M0) as assessed by a contrast-enhanced multislice computed tomography (CT) scan, positron
        emission tomography, or endoscopic ultrasonography were eligible.
      
Keywords: Neoadjuvant chemoradiotherapy; Neoadjuvant chemotherapy; Resectable oesophageal carcinoma; Effective; Safety
Project IMPACT: CHW Intervention
Condition: Hypertension
MeSH terms: Hypertension
Study type: Interventional

Summary: 
      The proposed study "Project IMPACT: CHW Intervention" is part of a larger study examining the
      efficacy, adoption, and impact of integrated EHR-based decision-support and physician
      feedback interventions with community health worker (CHW)-led self-management and coaching
      support for South Asian patients with uncontrolled hypertension. This is a randomized control
      intervention utilizing community health worker (CHW)-led self-management and coaching support
      for South Asian patients with uncontrolled hypertension at PCP clinics in New York City.
    

Detailed description: 
      The Goal of this study is that:

        1. EHR-based decision support and performance feedback interventions will be more effective
           in improving hypertension control for South Asian patients than standard care;

        2. A combined EHR-CHW intervention will be more effective in improving hypertension control
           for South Asian patients compared to standard care and the EHR-based intervention

      Investigators hope to implement and assess the efficacy of CHW-led coaching through promotion
      of team-based care and use of culturally tailored education to improve hypertension control
      and mitigate risk factors related to CVD among South Asian patients with uncontrolled
      hypertension. Study findings can provide translatable and scalable models for other limited
      English proficient communities.
    

Intervention name(s): CHW Intervention; Wait List Control Group
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Patients randomized to Group A will be invited to attend 4 more group educational sessions on self-management immediately.CHWs will follow up with participants by phone or in person through a home or clinic visit. At these follow-up meetings, CHWs will engage in goal-setting activities regarding changes to health behaviors, medication adherence, or other issues related to hypertension control as identified jointly by the patient and CHW. CHWs will also collect height, weight, and blood pressure measurements at initial and in-person follow-up visits. The CHW will make necessary referrals to other services available in the community (i.e. exercise classes, social services, mental health, tobacco cessation, etc.).; 4 education sessions beginning 6-12 months later.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Step wedge design, whereby 5 groups of 3 practices will implement the intervention in phases.
Masking: None (Open Label)
Primary purpose: Supportive Care
Promoting Cholesterol Screening
Condition: Cardiovascular Diseases; Lipid Testing; Primary Prevention of Cardiovascular Disease
MeSH terms: Cardiovascular Diseases
Study type: Interventional

Summary: 
      Cholesterol screening is an important prerequisite for cardiovascular disease (CVD) risk
      assessment. Cholesterol screening is recommended by the United States Preventive Services
      Task Force (USPSTF). Since reminder systems have been shown to modestly improve the rates of
      preventive services, including in safety net settings, we will implement patient-directed
      reminders to health center patients who meet our eligibility criteria.

      The aim of this study is to determine if a mailed outreach message and facilitated ordering
      of screening lipid tests increases cholesterol screening test completion within 3 months
      among federally qualified community health center patients who are eligible for screening
      compared to usual care.
    


Intervention name(s): Mailed patient outreach intervention
Intervention type(s): Behavioral
Intervention description(s): This study's intervention is a mailed outreach letter from the health center that encourages cholesterol testing and describes the steps necessary to obtain the test at the patient's care site. Clinic staff will facilitate the ordering of tests for patients who may not have an office visit.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: Cholesterol screening; High cholesterol; Cardiovascular disease; Statin treatment
ARTDIVA Study : First in Man Safety Evaluation of the ART18Z Bioresorbable Stent
Condition: Coronary Artery Disease
MeSH terms: Coronary Artery Disease; Myocardial Ischemia; Coronary Disease
Study type: Interventional

Summary: 
      This prospective, multicentre, open labeled, single arm, first in man interventional
      investigation aims to evaluate the safety of the ART18Z bioresorbable stent for the treatment
      of patients with single de novo lesion of a native coronary artery with mandatory balloon
      predilatation.
    


Intervention name(s): ART18Z Bioresorbable stent
Intervention type(s): Device
Intervention description(s): The drug free fully bioresorbable coronary stent ART18Z is a balloon expandable poly lactic acid stent.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Bioresorbable; Coronary; Stent; Vascular Remodeling; Angioplasty; Coronary Artery Disease
Combined Effect of LIMICOL and Physical Activity on LDL Cholesterol and Muscle Function.
Condition: Hypercholesterolemia
MeSH terms: Hypercholesterolemia
Study type: Interventional

Summary: 
      Cardiovascular disease (CVD), foremost among which ischemic heart disease and stroke, are the
      leading cause of mortality and morbidity in France. These diseases are multifactorial origin
      and even if it is not possible to act on risk markers such as age, sex, or heredity, risk
      factors like high cholesterol, smoking , hypertension, obesity, diabetes and physical
      inactivity, are the main target of prevention strategies. Dydlipidemias have a role in the
      formation of CVD in participating in the genesis of atherosclerosis. The cholesterol and
      LDL-cholesterol in particular is subject to oxidation process in plasma. The molecules of
      oxidized LDL-cholesterol, small and dense, easily penetrate the arterial endothelial wall and
      are greeted by macrophages. Following a succession of different processes including
      inflammation, atherosclerotic plaque is formed. The result is either an arteriopathy when the
      arterial lumen narrowing, or atherothrombosis in the event of plaque rupture. Given this
      pathophysiology, reduce blood lipids, including LDL-cholesterol and reducing oxidation and
      inflammation are interesting strategies in the context of cardiovascular prevention. Several
      scientific study showed that nutritional supplementation with some plant extracts such as
      artichokes, garlic, red yeast rice, or the sugar cane policosanol helps to reduce several
      cardiovascular risk factors including regulate concentrations of circulating lipids.

      In this study, we hypothesize that the food supplement LIMICOL contributes to reducing LDL
      cholesterol in the context of care for patients (dietary measures and physical activity)
    


Intervention name(s): LIMICOL; PLACEBO
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Suplementation with LIMICOL, 3 tablets per day, together with supervised physical activity (3 times per week) for 12 weeks.; Suplementation with PLACEBO, 3 tablets per day, together with supervised physical activity (3 times per week) for 12 weeks.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: Hypercholesterolemia; LDL cholesterol
Lacidipine In Mild To Moderate Essential Hypertension Patients With Type 2 Diabetes In Korea
Condition: Diabetes Mellitus, Type 2; Essential Hypertension
MeSH terms: Hypertension; Essential Hypertension; Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 4

Summary: 
      This study was designed to evaluate the anti-hypertensive efficacy of lacidipine in
      hypertensives with Type 2 diabetes and effectiveness on endothelial cell function in Korean
      population.
    


Intervention name(s): Lacidipine
Intervention type(s): Drug
Intervention description(s): Lacidipine 2, 4, 6mg
Intervention MeSH terms: Lacidipine
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Korean patients; Type 2 diabetes; Endothelial function; lacidipine; Essential hypertension
Administration of GRASPA (Suspension of Erythrocytes Encapsulating L-asparaginase)in Patients With Pancreatic Cancer
Condition: Pancreatic Cancer
MeSH terms: Pancreatic Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      The interest in using L-asparaginase in pancreatic cancer arose from in vitro and in vivo
      studies data showing an anti-neoplastic effect on pancreatic tumor cell lines. Interestingly,
      these studies suggest an additional effect of L-asparaginase associated to gemcitabine.GRASPA
      is a suspension of red blood cells encapsulating L-asparaginase. The aim of this phase I
      clinical trial is to evaluate the Maximum Tolerated Dose (MTD) of GRASPA on locally advanced
      or metastatic pancreatic tumors, after therapy failure of first or second line chemotherapy
      using gemcitabine.
    


Intervention name(s): GRASPA
Intervention type(s): Drug
Intervention description(s): Each patient will receive one administration of GRASPA . A stepwise increase of 4 single doses of GRASPA will be administered to cohorts of 3 patients per dose
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: pancreatic cancer; asparaginase
A Study to Compare the Safety and Efficacy of Cetrotide® 3 Milligram (mg) Versus Antagon™ in Women Undergoing Ovarian Stimulation
Condition: Infertile Women Undergoing Assisted Reproductive Technology (ART)
MeSH terms: Infertility
Study type: Interventional
Phase: Phase 4

Summary: 
      To demonstrate the comparative safety and efficacy of Cetrotide® 3 milligram (mg) and
      Antagon™ in the inhibition of a premature luteinizing hormone (LH) surge in women undergoing
      ovarian stimulation with recombinant human follicle stimulating hormone/human menopausal
      gonadotropin (r-hFSH/hMG) prior to assisted reproductive technology (ART) and utilizing oral
      contraceptives pill (OCP) for cycle programming.
    


Intervention name(s): Cetrotide®; Antagon ™; Recombinant human follicle stimulating hormone (r-hFSH); Human Menopausal Gonadotropin (hMG); Recombinant Human Choriogonadotropin (r-hCG)
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): Cetrotide® will be administered subcutaneously as 3 mg injection when the lead follicle is >=14 mm till r-hCG day. If the subject did not achieve follicular maturation and did not receive r-hCG within 4 days, then the Cetrotide® will be administered at dose of 0.25 mg subcutaneously on successive days until r-hCG day.; Antagon™ will be administered subcutaneously at a dose of 0.25 mg once daily when the lead follicle is >=14 mm until r-hCG day.; Recombinant human follicle stimulating hormone (r-hFSH) will be administered at a starting dose of 225 international unit (IU) subcutaneously once daily from S1 up to Stimulation Day 5 (S5). Beginning on Stimulation Day 6 (S6), the r-hFSH dose will be individualized to the subject. The minimum and maximum daily doses are 75 IU and 450 IU, respectively until r-hCG day.; Human menopausal gonadotropin (hMG) will be administered subcutaneously daily at a dose of 75 IU till r-hCG day. The total daily dose of r-hFSH and hMG combined is not to exceed 450 IU (375 IU r-hFSH and 75 IU hMG).; The r-hCG will be administered as a single dose of 250 microgram (mcg) subcutaneously when there is at least one follicle of >=18 mm and two additional follicles of >=16 mm with an appropriate plasma estradiol levels for the number and size of the existing follicles. The r-hCG will be administered within 36 hours after the last dose of the r-hFSH/hMG.
Other intervention name(s): Cetrorelix acetate; Ganirelix acetate; Gonal-f®; Pergonal®; Ovidrel®; Choriogonadotropin alfa
Intervention MeSH terms: Cetrorelix; Menotropins; Chorionic Gonadotropin; Hormones; Follicle Stimulating Hormone; Ganirelix
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Infertility; Cetrotide; Antagon; Recombinant human follicle stimulating hormone (r-hFSH); Human Menopausal Gonadotropin (hMG); Recombinant Human Choriogonadotropin (r-hCG)