bioihbjkbjnl/mcl2 huggingface dataset:
EYTO (European Youth Tackling Obesity): A Randomized Controlled Trial in Catalonia (Spain)
Condition: Obesity; Life Style
MeSH terms: Obesity
Study type: Interventional

Summary: 
      Our hypothesis is that healthy lifestyles improvement by an intervention designed according 8
      social marketing Benchmark criteria, can reduce overweight or obesity implemented by
      adolescents on their colleges.

      The general aim of EYTO program is to improve health and well-being among adolescents who
      live in low socioeconomically communities, through an intervention study designed by selected
      adolescents with the inclusion of social marketing Benchmark criteria.
    

Detailed description: 
      5 adolescent coordinators (of intervention high-schools) will be trained by experts in social
      marketing and health promotion. This 5 selected adolescent as coordinators who will be in
      charge of the design of an 8 social marketing criteria intervention to implement their peers´
      lifestyles.

      The program has over two academic years. The participants will be followed for the duration
      of 2 academic years, an expected of up to 16 months.
    

Intervention name(s): Social marketing activities and pop-up events to promote healthy lifestyles
Intervention type(s): Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Adolescent
Strategy for Maintenance of HIV Suppression With Once Daily Integrate Inhibitor+Darunavir/Ritonavir in Children
Condition: HIV Infection
MeSH terms: HIV Infections
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      A two-arm, Phase 2/3 multicentre, open-label, randomised study evaluating safety and
      antiviral effect of current standard antiretroviral therapy compared to once daily integrase
      inhibitor administered with darunavir/ritonavir (DRV/r) in HIV-1 infected, virologically
      suppressed paediatric participants.
    

Detailed description: 
      A two arm parallel group, non-inferiority, open-label, multi-centre, randomised controlled
      trial.
    

Intervention name(s): DTG +DRV/r; SOC
Intervention type(s): Drug; Drug
Intervention description(s): NRTI-sparing regimen: Once daily integrase inhibitor (INSTI) + darunavir/ritonavir (DRV/r); Standard of care (continuing triple anti-retroviral therapy including 2 NRTIs + boosted PI/NNRTI)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Evaluating Pancreatic Tumors in Patients With Zollinger-Ellison Syndrome
Condition: Zollinger Ellison Syndrome
MeSH terms: Zollinger-Ellison Syndrome; Gastrinoma; Syndrome
Study type: Observational

Summary: 
      This protocol concerns the approach to the localization, diagnosis of MEN1 and management of
      the tumor and the tissue samples in patients with Zollinger-Ellison syndrome. It details the
      diagnostic imaging tests to be used to localize the tumor, investigations for MEN1 the
      subsequent management of the tumor and tissue samples for research.
    

Detailed description: 
      This protocol concerns the approach to the localization and management of the tumor in
      patients with Zollinger-Ellison syndrome. It details the diagnostic imaging tests to be used
      to localize the tumor and the subsequent management of the tumor.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        patient population enrolled in protocol 89-DK-0015
      
Keywords: Zollinger-Ellison Syndrome; Natural History
Dipeptidyl Peptidase-4 Inhibitors and Alpha-cell Recovery
Condition: Type 1 Diabetes; Hypoglycemia
MeSH terms: Diabetes Mellitus, Type 1; Hypoglycemia
Study type: Interventional

Summary: 
      Hypoglycaemia is a well-known complication of insulin treated diabetes. The counterregulatory
      response to hypoglycaemia, with glucagon as the most important mediator, is initially
      diminished within a few years of onset of Type 1 diabetes and subsequently lost and thus
      increasing the risk of hypoglycaemia. Dipeptidyl Peptidase (DPP)-4 inhibitors augment the
      glucagon response to insulin-induced hypoglycaemia in type 2 diabetes. The investigators
      hypothesize that treatment with a DPP-4 inhibitor in patients with type 1 diabetes will
      recover the alpha cell response to hypoglycaemia.
    

Detailed description: 
      The 16 type 1 patients will be randomised to one of two treatment sequences: DPP-4 inhibitor
      followed by placebo or placebo followed by a DPP-4 inhibitor. Each treatment period lasts 6
      weeks, so all patients will receive treatment for 12 weeks in total. Induction of
      hypoglycaemia will take place at 0 weeks, 6 weeks and 12 weeks to determine the glucagon
      response.
    

Intervention name(s): Sitagliptin; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 100 mg once daily for six weeks; placebo, once daily for six weeks
Other intervention name(s): Januvia
Intervention MeSH terms: Sitagliptin Phosphate
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Keywords: Type 1 diabetes; DPP-4 inhibitor; Glucagon
Evaluation of Oral Plaque Removal Utilizing an Adjunct Enzyme Pre-rinse
Condition: Dental Plaque; Dental Caries
MeSH terms: Dental Caries; Dental Plaque
Study type: Interventional
Phase: Phase 2

Summary: 
      This study aims to investigate the impact of a bromelain pre-rinse adjunct on oral plaque
      removal in orthodontic subjects. The study's null hypothesis states that there is no
      statistically significant difference in visual plaque scores among orthodontic subjects with
      or without proteolytic enzyme rinse aid.
    

Detailed description: 
      Bromelain, a naturally occurring cysteine protease, from pineapple stalks, is used in food
      and medical industries and listed on the FDA's "Generally Recognized As Safe" (GRAS) list. In
      vitro bromelain study demonstrated antibacterial effect on oral pathogens. Bromelain was
      found to prevent biofilm formation by interfering with bacteria-bacteria adhesion and/or
      adhesion to enamel surface. Clinical trials with toothpaste containing bromelain demonstrated
      improved plaque and gingivitis scores and extrinsic enamel stain removal capabilities. The
      impact of bromelain application prior to traditional mechanisms of plaque removal have not
      been clearly evaluated.
    

Intervention name(s): Bromelain; Powdered sugar
Intervention type(s): Drug; Other
Intervention description(s): The subjects were randomized to either receive the bromelain pre-rinse or the powdered sugar placebo pre-rinse. Subjects then had a 5-9 day washout period and was then exposed to the other intervention.; The subjects were randomized to either receive the bromelain pre-rinse or the powdered sugar placebo pre-rinse. Subjects then had a 5-9 day washout period and was then exposed to the other intervention.
Other intervention name(s): proteolytic enzyme rinse; placebo rinse
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Enrolled subjects undergoing orthodontic treatment with fixed appliances will be randomized to receive either the Bromelain rinse or Placebo first and then will be crossed over to receive the opposite intervention. The study will consist of two treatment period (1 day) separated by a washout period of 1 week.
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: proteolytic enzyme; plaque removal; oral hygiene; orthodontic treatment
Evaluating Tocilizumab for Sever COVID-19 Infection in Breast Cancer vs. Non Cancer Pateints
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      To compare evaluating Clinical outcomes for patients treated with with or without breast
      cancer patients comorbidity for sever COVID-19 infection in breast cancer patients versus non
      cancer patients and evaluating Tocilizumab efficacy versus traditional therapy
    

Detailed description: 
      Cancer patients considered to be one of the least population that can be considered lucky
      during COVID 19 pandemic attributed that to long term treatment with chemotherapy,
      immunosuppression and multi comorbidities . Women with breast cancer are more likely to get
      covid-19 infection rather than other type cancers . the co-existing of two diseases breast
      cancer and Covid19 are very challengeable due to confusion and similarities found in clinical
      biomarkers to evaluate both diseases as ferritin, D dimers and C-reactive protein and all
      other immune response and cytokine storm syndrome especially including interleukin-6 (IL-6) .
      using chemotherapy or any other cytotoxic drugs may exacerbate the severity of COVID -19
      infection as well as poor clinical outcomes and even death are expected . The anti-human
      IL-6R monoclonal antibody (Tocilizumab) was used first in China in patients with severe
      COVID-19 and patients improved in different clinical outcome . In cancer patients
      particularly the issue is debatable about the benefits of receiving Tocilizumab.

      Clinical studies are going on such medication role in treatment of patients with severe covid
      19 infection however, studies have not clearly addressed the role of Tocilizumab breast
      cancer patient compared to non-cancer patients. This study aims to measure different clinical
      outcomes after using Tocilizumab in sever covid 19 infection in breast cancer patients vs.
      non cancer patients
    

Intervention name(s): Tocilizumab; traditional Covid -19 therapy
Intervention type(s): Drug; Drug
Intervention description(s): patients treated with Tocilizumab for Covid-19 infection; patients treated with traditional therapy for Covid-19 infection
Other intervention name(s): Actemra; DExa /Corticosteriods
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: comparative study two Covid-19 infected groups selected according to preexisting sever Covid -19 patients receiving Tocilizumab versus traditional thherapy
Masking: None (Open Label)
Primary purpose: Treatment
The Lira Pump Trial
Condition: Type 1 Diabetes
MeSH terms: Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      A randomized placebo-controlled clinical trial investigating the effects of Liraglutide as an
      add-on to intensive insulin therapy in overweight insulin pump treated type 1 diabetes
      patients in suboptimal glycemic control.
    


Intervention name(s): Liraglutide; Placebo
Intervention type(s): Drug; Drug
Other intervention name(s): Victoza
Intervention MeSH terms: Liraglutide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Bortezomib (Velcade) in Waldenstrom's Macroglobulinemia
Condition: Waldenstrom's Macroglobulinemia; Lymphoplasmacytic Lymphoma
MeSH terms: Waldenstrom Macroglobulinemia
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate how tumors in patients with Waldenstrom's
      macroglobulinemia respond to treatment with bortezomib (Velcade) and to see what effects
      (good and bad) it has on the cancer.
    

Detailed description: 
      -  Patients will receive bortezomib intravenously twice weekly for 2 weeks on days 1,4,8
           and 11 of each cycle. A 10-day rest period (days 12-21) will follow the 2 weeks of
           treatment. The treatment cycle is repeated up to eight times depending upon the disease
           response and if the patient is tolerating the drugs.

        -  The following procedures will be conducted as part of the treatment monitoring: DAY 1
           VISIT (of each treatment cycle): evaluation of disease-related symptoms, vital signs and
           weight and blood tests. DAY 4 VISIT (of each treatment cycle): vital signs and blood
           work. DAY 8 VISIT (of each treatment cycle): vital signs and blood work. DAY 11 VISIT(of
           each treatment cycle): vital signs, blood work, and possible CT Scan.

        -  Treatment will be discontinued if any of the following occur: Disease gets worse, severe
           side-effects or the patient requires other anti-cancer therapy.

        -  At the end of the treatment (30 days after the last dose of study drug) the patient will
           have a physical exam, vital signs, evaluation of disease-related symptoms, blood work
           and CT scan for tumor measurements.

        -  Long term follow-up consists of every 3 month clinical visits until disease progression
           or up to 2 years.
    

Intervention name(s): Bortezomib (Velcade)
Intervention type(s): Drug
Intervention MeSH terms: Bortezomib
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: bortezomib; Velcade; Waldenstrom's macroglobulinemia
Occlusal Splints in the Treatment of Sleep Bruxism
Condition: Sleep Bruxism, Adult; Splints; Sleep
MeSH terms: Bruxism; Sleep Bruxism
Study type: Interventional

Summary: 
      Occlusal splints are employed in the treatment of sleep bruxism. These appliances decrease
      sleep-related actions and damages bruxism, like grinding, tooth-wear, headache, and
      temporomandibular joint disorders. Occlusal splints are produced both in hard and soft forms
      according to the used material.

      In this study, it was aimed to evaluate the effect of occlusal splint type on the sleep
      quality and occlusal force parameters of patients with sleep bruxism.
    

Detailed description: 
      Various splint designs have been used for the treatment of sleep bruxism that is made up of
      different materials: Hard and soft splints. Although, these splints have slightly different
      appearances and properties, in fact, scientific evidence supports both the use of hard and
      soft occlusal splints. Hard splints are more preferred when compared to soft ones, thus, oft
      appliances have been less documented in the scientific literature. However, some studies
      suggested the use of soft-resin splints that are easily fabricated and may be inserted at an
      initial appointment, dental clinicians may desire the use of soft appliances. One of the
      advantages of these appliances is they are easy to tolerable to the patient and comfortable.
      Additionally, these splints fit tightly and provide a flat plane during sleep.

      Considering these advantages, the present study was designed to examine the effect of the use
      of different types of occlusal splints on the sleep quality and occlusal force of patients
      with sleep bruxism. For this purpose, the effect of two splints basically fabricated from two
      different materials were evaluated and compared. The null hypothesis was that the use of both
      occlusal splints would not change the values of sleep quality and maximum occlusal force of
      the patients with sleep bruxism.
    

Intervention name(s): Occlusal splint
Intervention type(s): Device
Intervention description(s): Using occlusal splints during sleep for 2 months
Intervention MeSH terms: Salicylic Acid
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized clinical trial
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: sleep quality; occlusal splint; bruxism
Effect of Chlorogenic Acid on Patients With Impaired Glucose Tolerance
Condition: Impaired Glucose Tolerance
MeSH terms: Glucose Intolerance
Study type: Interventional
Phase: Phase 2

Summary: 
      Chlorogenic acid has demonstrated promising effects in the treatment of glycemic control,
      obesity, dyslipidemia, insulin secretion, among others. The above mentioned findings show
      that Chlorogenic acid has an excellent potential for the control of glucose as well as
      insulin secretion and insulin sensitivity.
    

Detailed description: 
      A randomized, double-blind, placebo-controlled clinical trial was carried out in 30 patients
      with a diagnosis of impaired glucose tolerance in accordance with the American Diabetes
      Association criteria. The patients received 400 mg capsules of Chlorogenic acid or placebo,
      three times daily 1/ 2 hour before meals for 90 days. Before and after intervention the
      investigators evaluated: 2 hours plasma glucose, glycated hemoglobin (A1C), triglycerides,
      high-density lipoprotein, fasting glucose and blood pressure body weight, body mass index,
      waist circumference, total cholesterol, low-density lipoprotein, very-low-density
      lipoprotein, creatinine, aspartate transaminase and alanine transaminase.

      Were calculated: Areas under the curve of glucose and insulin were calculated with de
      Trapezoidal formula. Total insulin secretion was evaluated with the Insulinogenic index and
      the insulin sensitivity was estimated using the Matsuda index.
    

Intervention name(s): Placebo; Chlorogenic acid
Intervention type(s): Drug; Drug
Intervention description(s): Placebo: 1200 mg per day for three months; Chologenic acid: 1200 mg per day for three months
Other intervention name(s): Calcined magnesia; 3-O-Caffeoylquinic, acid Heriguard
Intervention MeSH terms: Magnesium Oxide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Chlorogenic acid; Control glucose; Insulin Secretion; Insulin Sensitivity
Galantamine-CR and Cognitive Dysfunction in Bipolar Disorder
Condition: Bipolar Disorder
MeSH terms: Bipolar Disorder
Study type: Interventional

Summary: 
      The purpose of the study is to determine whether the investigational drug galantamine-CR
      (Reminyl- Controlled Release capsule) is useful in improving problems with memory in bipolar
      patients with stable mood. This study is being done because a large proportion of patients
      with bipolar disorder experience significant memory problems, even when their mood is stable,
      after adequate treatment. These memory problems have been associated with poor daily social
      functioning. Studying galantamine-CR in this population may provide a new clinical way to
      combat memory problems in stable patients with bipolar disorder.
    


Intervention name(s): Galantamine-CR
Intervention type(s): Drug
Intervention MeSH terms: Galantamine
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Dose Finding Study to Assess Safety and Efficacy of Stem Cells in Liver Cirrhosis
Condition: Alcoholic Liver Cirrhosis
MeSH terms: Liver Cirrhosis; Liver Cirrhosis, Alcoholic; Fibrosis
Study type: Interventional
Phase: Phase 2

Summary: 
      This study will evaluate the safety and efficacy of mesenchymal stem cells in patients with
      cirrhosis of liver. Stem cells will be injected into the hepatic artery. Improvement in
      various parameters will be observed over 2 years.
    


Intervention name(s): Allogeneic Mesenchymal Stem Cells; Allogeneic Mesenchymal Stem Cells; Allogeneic Mesenchymal Stem Cells
Intervention type(s): Biological; Biological; Biological
Intervention description(s): High dose of Bone Marrow Derived Allogeneic Mesenchymal Stem Cells will be administered through the hepatic artery; Intermediate dose of Bone Marrow Derived Allogeneic Mesenchymal Stem Cells will be administered through the hepatic artery; Low dose of Bone Marrow Derived Allogeneic Mesenchymal Stem Cells will be administered through the hepatic artery
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Alcoholic; Liver; Cirrhosis; Stem; Cells
Targeting the Gut Microbiome for Prader-Willi Syndrome Treatment
Condition: Prader-Willi Syndrome
MeSH terms: Prader-Willi Syndrome; Syndrome
Study type: Interventional

Summary: 
      The gut microbiome has recently emerged as a major contributor to obesity, systemic
      inflammation, and metabolic disease. Furthermore, intestinal bacteria are crucial players in
      the gut-brain axis, regulating a broad range of central nervous system processes, from
      satiety mechanisms to anxiety and social behavior. Thus, targeting the microbiome is being
      actively investigated as a therapeutic strategy for a wide array of diseases, including
      obesity, anxiety, depression, and autism. Among all intestinal bacteria, Bifidobacterium
      animalis spp. lactis (BAL) has shown promise for obesity treatment in experimental animal
      models and human subjects, improving body composition and metabolic health, and reducing
      energy intake. Moreover, tryptophan metabolism, a crucial regulator of satiety mechanisms and
      anxiety, is a main target of BAL. Given that clinical manifestations of Prader-Willi syndrome
      (PWS) include hyperphagia, anxiety, altered body composition, and metabolic dysregulation,
      the aforementioned effects of BAL might prove highly beneficial for children with PWS. Here,
      the investigators will test this hypothesis by performing a randomized double-blinded
      placebo-controlled crossover clinical study to assess the effects of BAL supplementation on
      an array of clinical manifestations of PWS. Children with PWS will undergo a 3-month
      placebo/probiotic treatment period, a 3-month washout period, followed by a 3-month
      probiotic/placebo supplementation. Anthropometric, biochemical, and psychological data as
      well as biological samples will be obtained at the beginning of the study, and after each of
      the study periods, with a total of four time-points. Specifically, the investigators will
      determine body composition by DXA analysis; metabolic health by assessing glucose and lipid
      metabolic parameters as well as circulating hormonal and cytokine levels; thermoregulation by
      non-invasive thermal imaging; and hyperphagia and emotional and behavioral problems by
      applying parental-rated validated questionnaires.
    


Intervention name(s): Placebo; Probiotic
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Intervention with a daily dose of placebo; Intervention with a daily dose of probiotic
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment