bioihbjkbjnl/mcl2 huggingface dataset:
Immune Effects of Vitamin D in Hemodialysis Patients
Condition: End Stage Renal Disease; Hemodialysis; Inflammatory Response; Cardiovascular Disease
MeSH terms: Kidney Failure, Chronic; Cardiovascular Diseases
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study to examine whether vitamin D can reduce the activation of the
      immune system during dialysis. When activated, the immune cells release certain substances,
      called cytokines, which can be measured from small blood samples. We want to study to what
      degree the immune system is activated during a regular dialysis treatment and whether the
      time point of vitamin D administration, either right before the start or right at the end of
      a dialysis treatment, has an impact on the activation of the immune system.
    


Intervention name(s): paricalcitol
Intervention type(s): Drug
Intervention description(s): Dosage Form: Intravenous administration. Dosage: 0.01 micrograms/kilogram of body weight. Frequency: 2 HD treatments of each study week (depending on phase of study). Duration: 4 weeks.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
E-health Care Process Support for Diabetes Type II Patients
Condition: Diabetes Mellitus Type II,
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      The purpose of the study is to clinically evaluate a new approach to treatment of patients
      with diabetes mellitus type II by using specially developed mobile-internet software
      solution.

      The effect of information and communication technologies (ICT) to improve the integrated care
      of people with diabetes will be identified, developed, introduced and clinically evaluated.

      The investigators expect that usage of an e-Health application in health care of patients
      with diabetes mellitus type II could improve the following healthcare outcomes: results of
      the laboratory tests (with emphasis on HbA1C value), regular medication usage, blood pressure
      values, Body mass index (BMI) values, diet, regular exercise and quality of life.
    

Detailed description: 
      Diabetes mellitus (DM) is defined as a "group of common metabolic disorders that share the
      phenotype of hyperglycemia". It is generally agreed that in Caucasian populations the
      prevalence rate is between 2% and 6%. Prevalence rate of DM in SLovenia is about 5%. Type 2
      DM accounts for 90% to 95% of all diabetes cases.

      Results of many clinical studies demonstrated the great potential of information and
      communication technology (ICT) applications to improve health care of patients with chronic
      diseases including diabetes mellitus.

      In this study an ICT mobile environment to improve the process of an integrated care of
      people with Diabetes mellitus will be identified, developed, introduced and clinically
      evaluated. The study will include 140 patients diagnosed with diabetes mellitus type II who
      are managed in primary care. The study will use and evaluation questionnaire that will cover
      issues regarding the patient quality of life.

      Subjects with a blood pressure meter and a scale, will be able to enter the value of the
      systolic and diastolic blood pressure and the body weight.

      Subjects will be motivated to regularly enter data about their blood pressure, body weight,
      dietary misconducts and to complete available questioners. In addition to this, users can
      enter values about their physical activity (type, duration, intensity).
    

Intervention name(s): Computerised support to the Diabetes type II patients
Intervention type(s): Procedure
Intervention description(s): The randomly selected group of patients with diabetes type II will get software application and web based support to their usual healthcare process.
Other intervention name(s): eDiabetes in Primary healthcare
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Diabetes mellitus tip II; eHealth solution; Health Information Technology; quality of life; family medicine; satisfaction with e-health care; primary care
A Comparison Of A Single PF-04634817 Tablet Dose Compared With A Solution In Healthy Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This study investigates the safety, tolerability and pharmacokinetics of PF-04634817 when
      respectively given orally as a single tablet dose and a single dose of a solution.
    


Intervention name(s): PF-04634817; PF-04634817
Intervention type(s): Drug; Drug
Intervention description(s): single dose, 20mg, tablet; single dose, 20mg, solution
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Phase 1; relative bioavailability; healthy volunteers; pharmacokinetics; solution; tablet
Epilepsy Phenome/Genome Project
Condition: Epilepsy; Localization-related Epilepsy; Infantile Spasms; Lennox-Gastaut Syndrome; Polymicrogyria; Periventricular Heterotopias
MeSH terms: Epilepsy; Lennox Gastaut Syndrome; Spasms, Infantile; Epilepsies, Partial; Polymicrogyria; Periventricular Nodular Heterotopia; Choristoma
Study type: Observational

Summary: 
      The purpose of this study is to collect detailed information about the characteristics and
      genetics of a large number of individuals with epilepsy.
    

Detailed description: 
      Epilepsy is one of the most common neurological disorders and is a major public health
      concern. Approximately 30 percent of people with epilepsy have medically intractable
      epilepsy, and the medical and social consequences of the disorder are enormous. Treatments
      developed for epilepsy have largely been experimental rather than based on knowledge of basic
      mechanisms because the mechanisms are poorly understood.

      The Epilepsy Phenome/Genome Project (EPGP) is a large-scale, international,
      multi-institutional, collaborative research project aimed at advancing the understanding of
      the genetic basis of the most common forms of epilepsy.

      The overall goal of EPGP is to collect detailed, high quality phenotypic (i.e.,
      characteristics of individuals, from the molecular level to the whole person) information on
      persons with epilepsy and to compare the phenotypic information with genomic information.
      EPGP will provide a resource that may lead to many discoveries related to the diagnosis and
      treatment of epilepsy, including the eventual development of new therapies based on a better
      understanding of causes of the disorder.
    

Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        EPGP will recruit persons with specific forms of epilepsy.
      
Biospecimen description: 
      whole blood
    
Keywords: epilepsy; localization-related epilepsy; idiopathic generalized epilepsy; infantile spasms; Lennox-Gastaut syndrome; polymicrogyria; periventricular heterotopias; malformations of cortical development; phenome; genome; genotype; phenotype
The Role of Nicotine Dose and Route of Delivery in Affecting Adoption of E-cigarettes and Reducing Exposure to Toxic Combustion Products
Condition: Nicotine Dependence, Cigarettes
MeSH terms: Tobacco Use Disorder
Study type: Interventional
Phase: Phase 2

Summary: 
      This study plans to investigate whether using electronic cigarettes (e-cigarettes) or skin
      patches containing nicotine affects switching from smoking conventional combustible (burning)
      cigarettes.
    

Detailed description: 
      This study proposes to assess the relative role of nicotine dose and route of delivery in
      affecting successful switching from combustible cigarettes to e-cigarettes, as well as
      concomitant reductions in ad libitum cigarette smoking and exposure to harmful and
      potentially harmful constituents of combustion. The strategy will be to assess adoption of
      e-cigarette use and concomitant reduction in ad libitum smoking of subjects' usual brands of
      cigarettes over an 8-week period, during which they will receive nicotine or non-nicotine
      e-cigarettes, and nicotine skin patches. The nicotine patches will not be used as a
      therapeutic treatment in this study, but rather as a way to manipulate the nicotine dose,
      while varying the rate and route of nicotine delivery. Behavioral or "habit" aspects of
      e-cigarette use will be controlled for by the groups receiving non-nicotine e-cigarettes.
      Initially the study design included placebo patch control conditions, but due to limitations
      in budget and period of support, enrollment in these these arms was discontinued. All
      participants currently receive active nicotine patches.
    

Intervention name(s): Nicotine patch; Placebo patch; E-cigarettes; Non-nicotine e-cigarettes
Intervention type(s): Drug; Other; Other; Other
Intervention description(s): Participants will wear the nicotine patch daily while switching from cigarette use to use of e-cigarettes for eight weeks.; Participants will wear the placebo patch daily while switching from cigarette use to use of e-cigarettes for eight weeks.; Participants will use e-cigarettes containing nicotine while switching from cigarette use to use of e-cigarettes for eight weeks.; Participants will use e-cigarettes not containing nicotine while switching from cigarette use to use of e-cigarettes for eight weeks.
Other intervention name(s): NicoDerm; Electronic Nicotine Delivery System (ENDS); e-cigs; electronic cigarettes; Electronic Nicotine Delivery System (ENDS); e-cigs; electronic cigarettes
Intervention MeSH terms: Nicotine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Basic Science
Keywords: Nicotine addiction; Cigarette smoking; Nicotine patches; E-cigarettes
Onset of Labour Epidural Analgesia With Different Concentration Bupivacaine and Different Doses of Sufentanyl
Condition: Pregnant Women Who Requested Epidural Analgesia in the Early Stage of Labor
MeSH terms: Agnosia
Study type: Interventional
Phase: Phase 4

Summary: 
      This study aimed to compare the effects of three commonly used combination doses on the onset
      time and adverse reactions.
    

Detailed description: 
      Epidural block is widely used as an analgesic method during labor. During epidural
      anaesthesia, lipophilic opioids such as sufentanil, are often combined with local anesthetics
      to prolong the duration of analgesia and improve the analgesic effect. However, dose
      combinations of local anesthetics and opioids, especially in the initial loading dose, vary
      greatly from hospital to hospital and often depend upon the different routines adopted by
      anesthesiologists. In clinical practice, there are still some controversy about opioid dose
      selection in terms of analgesic onset time and adverse reactions.

      In this study, three combinations of bupivacaine and sufentanil were chosen, commonly used in
      the clinic, and extended the observation period to 24 hours after delivery. We hypothesized
      that increasing the concentration of local anesthetic, rather than increasing the dose of
      sufentanil, would achieve a faster analgesic effect with minimal adverse effects on the
      mother and fetus. To test our hypothesis, our primary outcome was to compare the times of
      analgesia onset of the three combinations, and the secondary outcomes were to compare the
      effects on maternal and infant adverse reactions.
    

Intervention name(s): B1S5; B125S5; B1S10
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Women were then placed supine with left uterine displacement. Epidural labour analgesia was initiated with 5µg sufentanyl along with 5 ml bupivacaine 0.1% as the test dose. After 3 min, 10 ml of 0.1% bupivacaine epidural was injected; Women were then placed supine with left uterine displacement. Epidural labour analgesia was initiated with 5µg sufentanyl along with 5 ml bupivacaine 0.125% as the test dose. After 3 min, 10 ml of 0.125% bupivacaine epidural was injected; Women were then placed supine with left uterine displacement. Epidural labour analgesia was initiated with 10µg sufentanyl along with 5 ml bupivacaine 0.1% as the test dose. After 3 min, 10 ml of 0.1% bupivacaine epidural was injected
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Ambulatory Laparoscopic Sleeve Gastrectomy
Condition: Obesity, Morbid
MeSH terms: Obesity, Morbid
Study type: Interventional

Summary: 
      In the era of laparoscopic surgery, day case procedures are increasingly practiced around the
      world, however, day case bariatric surgery remains a controversial issue due to lack of
      sufficient evidence evaluating its safety. Laparoscopic sleeve gastrectomy (LSG) is currently
      the most popular bariatric surgery performed worldwide, and the standard is 1-2 days postop
      stay. However, the American College of Surgeons and the American Society for Metabolic and
      Bariatric Surgery released guidelines in 2016 that allowed LSG in ambulatory surgery centers
      for low acuity patients. In the present trial, investigators will compare the safety and
      feasibility of same day discharge vs next day discharge in a large group of patients
      undergoing laparoscopic sleeve gastrectomy.
    

Detailed description: 
      This is a 2-group, randomized, open label clinical trial patients who will be recruited at an
      ASC to undergo LSG with same-day discharge, termed Ambulatory Surgery Center LSG (ASC LSG) or
      LSG with conventional hospitalization and next day discharge (CH LSG). The study will recruit
      participants between December 2018 and December 2020. Data collected will include including
      age, body mass index (BMI), operative time, recovery room time, hospital stay, readmission,
      follow up visits, ASC visits, adverse events, and re-operation rates.
    

Intervention name(s): Ambulatory Laparoscopic Sleeve Gastrectomy; Conventional Laparoscopic Sleeve Gastrectomy
Intervention type(s): Procedure; Procedure
Intervention description(s): Same-day discharge; Next-day discharge
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: sleeve gastrectomy; ambulatory surgery; day case surgery
Impact of Albendazole -Ivermectin on Wuchereria Bancrofti in Mali
Condition: Lymphatic Filariasis
MeSH terms: Filariasis; Elephantiasis, Filarial; Elephantiasis
Study type: Interventional
Phase: Phase 4

Summary: 
      Lymphatic filariasis is a public health problem in Mali. The existing data are not up to date
      and most of them are more than 15 years old. To address this issue in April 2000, the
      investigators started studies to update the epidemiology of lymphatic filariasis. There is no
      ongoing lymphatic filariasis control program in 2000 in Mali in terms of preventive
      chemotherapy treatment or vector control.

      To fill these gaps, this current study aims to assess the impact of albendazole-ivermectin
      combination treatment on Wuchereria bancrofti infection and transmission in 6 rural highly
      endemic villages of Mali.
    

Detailed description: 
      Lymphatic filariasis is a public health problem in Mali. The existing data are not up to date
      and most of them are more than 15 years old. To address this issue in April 2000, the
      investigators started studies to update the epidemiology of lymphatic filariasis. As a
      result, in two rural areas (Banambani and Sirakoro) located at about 25 km North-East Bamako,
      the parasite prevalence using ICT cards in August 2000 were 16% (n=150) and 15.0% (n=113)
      respectively in Banambani and Sirakoro. There is no ongoing lymphatic filariasis control
      program in 2000 in Mali in terms of preventive chemotherapy treatment or vector control.

      To fill these gaps, this current study aims to assess the impact of albendazole-ivermectin
      combination treatment on Wuchereria bancrofti infection and transmission in 6 rural highly
      endemic villages of Mali.

      The study will be conducted in three phases: the pre treatment assessment of lymphatic
      filariasis infection and transmission parameters, treatment phase with annual single dose of
      albendazole and ivermectin and the post treatment assessment of Anopheles gambiae s.l
      mosquitoes, the transmission parameters of the vectors in the community, human infection
      prevalence post treatment using Giemsa -stained thick smears and others test like the Immuno
      chromatographic test (ICT).
    

Intervention name(s): ''albendazole'' and ''ivermectin''
Intervention type(s): Drug
Intervention description(s): annual single dose administration of albendazole 400mg and ivermectin 150ug/kg of weight (according to the height)
Other intervention name(s): Zentel and Mectizan
Intervention MeSH terms: Ivermectin; Albendazole
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Wuchereria bancrofti; Anopheles; Albendazole; Ivermectin; MDA
Rapid Dose Escalation of Quetiapine Versus Conventional Escalation in Acute Schizophrenic Patients
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of the study is to compare the safety and tolerability of IR (Immediate-Release)
      quetiapine in a rapid escalation scheme with to the current approved label titration.
    


Intervention name(s): IR (Immediate-Release) quetiapine fumarate (drug)
Intervention type(s): Drug
Intervention MeSH terms: Quetiapine Fumarate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Schizophrenia
Infertility Markers in Serum, Urine, and Follicular Fluid
Condition: Infertility
MeSH terms: Infertility
Study type: Observational

Summary: 
      This study is only collecting specimens from current patients of PENN Fertility Care.

      The purpose of this investigation is to assess if markers of oxidative stress that are known
      to be associated with other medical conditions can be detected in women undergoing
      infertility treatment and normal women of similar age. Oxidative stress may affect a woman's
      eggs or the follicular cells that surround and nurture them. Other markers of to be
      investigated include markers of cellular aging and DNA structural changes.

      Presence of these markers will be compared in blood and urine samples taken during
      infertility treatment, and follicular fluid at the time of IVF (if applicable).
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Women undergoing In vitro fertilization at the University of Pennsylvania
      
Biospecimen description: 
      Blood, Urine, Follicular Fluid
    
Keywords: Infertility; Oxidative stress
Adapted Dialectical Behaviour Therapy for Adolescents With Deliberate Self-Harm: A Pre-post Observational Study
Condition: Deliberate Self Harm; Borderline Personality Disorder
MeSH terms: Self Mutilation; Personality Disorders; Borderline Personality Disorder; Self-Injurious Behavior
Study type: Interventional

Summary: 
      The investigators conducted a pre-post naturalistic study regarding changes observed
      associated with a 15-week course of an adapted form of dialectical behaviour therapy for
      adolescents. We measured frequency of self-harm prior to treatment and after treatment using
      the Self-Injurious Thoughts and Behaviors Interview. We also measured changes using the
      Suicide Ideation Questionnaire, Life Problems Inventory, Resiliency Scale for Children and
      Adolescents.
    


Intervention name(s): A-DBT-A
Intervention type(s): Behavioral
Intervention description(s): Adapted Dialectical Behaviour Therapy for Adolescents
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Bacteria Elimination in Retreatment Cases Using Different Disinfection Techniques
Condition: Root Canal Infection; Periapical; Infection
MeSH terms: Infections; Communicable Diseases
Study type: Interventional

Summary: 
      Nonsurgical root canal retreatment may become essential when the initial endodontic treatment
      fails because of the persistent intracanal or extracanal infections.It has been stated that
      the one of the main cause of posttreatment disease is the persistent or reintroduced
      microorganism such as enterococcus faecalis. Supplementary disinfection techniques such as
      irrigation agitation methods can help elimination of bacteria from root canal systems.

      The aim of this in vivo study was to compare the effect of passive ultrasonic irrigation,
      manual dynamic activation and photodynamic therapy in reducing bacterial load in endodontic
      retreatment cases with periradicular lesion by using polymerase chain reaction (PCR)in a
      single visit root canal treatment.
    

Detailed description: 
      Thirty-six teeth with a single root and a single canal with posttreatment apical
      periodontitis which needed retreatment were selected for this study. Teeth were randomly
      divided into 3 groups according to the supplementary disinfection techniques used: Passive
      ultrasonic irrigation, Manual dynamic activation and Photodynamic therapy. Microbiological
      samples were taken before any intervention, after conventional chemo-mechanical preparation,
      and after disinfection techniques with sterile paper points and held in thioglycollate broth,
      and then were transferred to the microbiological laboratory. The amounts of e.faecalis in
      these samples was measured by using PCR.
    

Intervention name(s): VDW Ultra; AMD picasso; ProtaperNext X3 gutta-percha
Intervention type(s): Device; Device; Device
Intervention description(s): supplementary disinfection technique; supplementary disinfection technique; supplementary disinfection technique
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: photodynamic therapy; diode laser