bioihbjkbjnl/mcl2 huggingface dataset:
Biochemical Mediators After Implant Loading
Condition: Implant Loading
Study type: Observational

Summary: 
      This study evaluates the nitric oxide and arginase levels in patients with dental implants.
      Peri-implant sulcular fluid and saliva samples were collected after loading of the implants
    

Detailed description: 
      Nitric oxide (NO) metabolism is associated with the clinical inflammatory state of
      peri-implant tissues and also affected by the mechanic stimulus. Therefore, The NO content of
      PISF reflects two different measures and can serve as an indicator of peri-implant soft
      tissue inflammation and/or bone response to force application and loading Arginase may reduce
      NO production by depleting the common substrate. Thus, increased salivary arginase activities
      detected in periodontitis patients may cause decreased NO synthesis and lead to a decrease in
      the antibacterial property of saliva.
    

Observational model: Case-Only
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Twenty patients with one or more implants restored with fixed crown prostheses
      
Keywords: nitric oxide; arginase; loading
A Multiple Dose Investigational Drug Study in Patients With Type 2 Diabetes (MK-0941-005)
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      A multiple dose study to assess the safety and pharmacokinetics of an investigational drug in
      patients with type 2 diabetes. The primary hypotheses of the study are that multiple daily
      MK-0941 in subjects with T2DM with or without adequate control on metformin will be
      sufficiently safe and well tolerated to permit continued clinical investigation.
    


Intervention name(s): MK0941; Comparator: Placebo
Intervention type(s): Drug; Drug
Intervention description(s): MK0941 10 mg, 20 mg, 30 mg, or 40 mg before each meal or before 2 meals each day, or 60 mg before 2 meals each day; Placebo 10 mg, 20 mg, 30 mg, or 40 mg before each meal or before 2 meals each day, or 60 mg before 2 meals each day
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Efficacy of Multiple Micronutrient Fortified Biscuits and Deworming in Vietnamese School Children
Condition: Healthy
Study type: Interventional
Phase: Phase 2

Summary: 
      The aim of this study is to identify the effect of a school-based food fortification
      intervention with multi-micronutrients with or without deworming to improve anemia,
      micronutrient status, cognitive function, health (morbidity and reinfestation rate) and
      growth (ponderal) in Vietnamese primary schoolchildren.
    

Detailed description: 
      Concurrent micronutrient deficiencies are prevalent in schoolchildren in Vietnam. These
      deficiencies not only lead to anemia, impair growth, increase susceptibility to infection,
      impair work capacity, but also impair cognitive development and impair learning ability. The
      risk of micronutrient deficiencies and anemia increases when individuals are exposed to
      intestinal helminth infections. Schoolchildren are a neglected group with regard to
      micronutrient interventions, and school programs afford an excellent opportunity to improve
      health of these groups. Food fortification with multi-micronutrients is a cost-effective and
      sustainable strategy, but is not yet implemented on a large scale in Vietnam. Furthermore,
      little is known about whether high prevalence of intestinal helminthic infection in
      schoolchildren limits the effect of fortification when this is not combined with regular
      de-worming.
    

Intervention name(s): worm treatment and multiple micronutrient fortified biscuits
Intervention type(s): Dietary Supplement
Intervention description(s): A single dose of intestinal anthelminthic treatment as orange-flavored chewable tablets containing 400 mg Albendazole (Vidoca, Thephaco, Vietnam) was given. Deworming was repeated with Albendazole for all children at the end of the study (after 4 months).
The composition and amount of nutrients in each serving of fortified biscuit were 6 mg iron, 5.6 mg zinc, 35µg iodine, 300 µg RAE vitamin A, 1.0 mg thiamin, 0.9 mg riboflavin, 1.1 mg vitamin B6, 10.5 mg NE niacin, 1.5 µg vitamin B12, 120 µg folic acid, 28 mg vitamin C, 150 mg calcium, 74 IU vitamin D, 40 mg magnesium, 6.8 µg selenium, 378 mg potassium, 70 mg phosphorus, 3.0 mg pantothenic acid, 2.8 µg vitamin E, 10 µg vitamin K and 18 µg biotin.
Other intervention name(s): Vidoca (Thephaco, Vietnam)
Intervention MeSH terms: Micronutrients; Trace Elements
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: Efficacy; Vietnam; school children; anemia; fortification; micronutrient
Eccentric Exercise and Oxidative Stress
Condition: Aging; Muscle Damage; Oxidative Stress
Study type: Interventional

Summary: 
      The purpose of the present investigation is to compare the responses and adaptations of young
      and elderly individuals to repeated eccentric exercise in regards to muscle function and
      redox homeostasis in a side-by-side comparison.
    

Detailed description: 
      Despite the progress of analytic techniques and the refinement of study designs, striking
      disagreement exists among studies regarding the influence of exercise on muscle function and
      redox homeostasis in the elderly. A specific exercise protocol will be applied (the repeated
      eccentric model) to produce long-lasting and extensive changes in redox biomarkers and to
      examine more easily the potential effects of aging. Ten young men and ten elderly men will
      underwent an isokinetic eccentric exercise session, which will be repeated after three weeks.
      Muscle function indices and redox biomarkers will be assessed in urine, plasma or
      erythrocytes pre exercise, immediately post exercise, 2 and 4 days post exercise.
    

Intervention name(s): Exercise
Intervention type(s): Other
Intervention description(s): Participants will perform two isokinetic eccentric exercise bouts
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Aging; Skeletal muscle; Biomarkers; Adaptation
Study of a Healthy Lifestyle Intervention for Deaf Adults Who Are Overweight or Obese
Condition: Overweight; Obesity
MeSH terms: Overweight
Study type: Interventional

Summary: 
      The purpose of the Deaf Weight Wise study is to test a 16 week, evidence-based, comprehensive
      program to change obesity-related health behaviors in Deaf people who use American Sign
      Language (ASL) as their primary language.

      Participants will be randomized to one of two study arms - immediate intervention or delayed
      intervention. In addition to the intervention activities, participants will also take part in
      five study visits over the course of two years. At these study visits, the investigators will
      administer several surveys as well as conduct biometric assessments.

      The investigators primary hypothesis is that the immediate intervention group will increase
      their levels of physical activity and reduce their caloric intake and body weight immediately
      following the intervention, compared to the delayed intervention group.
    


Intervention name(s): Deaf Weight Wise program
Intervention type(s): Behavioral
Intervention description(s): Groups will consist of approximately 13 subjects who meet for 2 hours a week for 16 weeks. Group sessions will be offered at a variety of times and days of the week. A trained, deaf, ASL-fluent counselor will lead the sessions.
Subjects will be asked to complete a food and physical activity diary. Each intervention session will include a weigh-in, group sharing/problem solving, discussion of a weight management topic, and goal setting/action planning for the next week. Periodically, each subject will receive a Personal Feedback Report. Subjects will be able to earn points for complying with various aspects of the program. Points can be redeemed for small prizes (i.e. water bottles).
The maintenance phase consists of two meetings at the beginning of the 6-month maintenance period and three months later. This will consist of a weigh-in, review of self-monitored diet and physical activity, problem solving and goal setting/action planning for their long-term program.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Efficacy of Pegylated Interferon Alone in Egyptian Patients With Acute Hepatitis C (ANRS 1213)
Condition: Hepatitis C
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis
Study type: Interventional
Phase: Phase 3

Summary: 
      Acute hepatitis C is a liver disease related to a virus: hepatitis C virus (HCV). The type of
      Hepatitis C Virus present in Egypt (genotype 4), has the reputation to respond poorly to
      treatment at the chronic hepatitis stage. Without treatment, 85% of patients with acute
      hepatitis C become chronically HCV infected which means that the virus stays present in the
      body. Pegylated Interferon is a new form of Interferon that stays in the body for longer time
      and allows the patient to take less injection per week. It has also proved to be more
      effective than standard Interferon in treatment of chronic hepatitis C.
    

Detailed description: 
      Egypt is the country with the highest HCV prevalence worldwide, and the number of infected
      Egyptians is estimated around 8 million. HCV incidence is high as well, and a typical
      hepatology department in Cairo diagnoses between 5 and 10 acute hepatitis C per month. The
      HCV genotype circulating in Egypt is genotype 4. This genotype has the reputation to respond
      poorly to treatment at the chronic hepatitis stage. It would therefore be interesting to
      assess the treatment efficacy at the acute stage. This study will evaluate the efficacy of
      pegylated interferon (peg-IFNα-2a) alone in Egyptian patients with acute hepatitis C.

      The study primary objective is to evaluate the efficacy and tolerance of pegylated interferon
      (peg-IFNα-2a) alone in Egyptian patients with acute hepatitis C.

      Methods: One arm clinical trial. Follow-up duration: 36 to 48 weeks depending on response to
      treatment.

      Main inclusion criteria: ALT> 3*N; HCV RNA positive by PCR and negative HCV serology at first
      presentation or positive HCV serology with a clear and unique exposure within 2 months prior
      the acute hepatitis episode; no prior treatment with IFNα, peg-IFNα and ribavirin; signed
      informed consent.

      Main exclusion criteria : Liver disease other than hepatitis C. Treatment strategy:
      Peg-IFNα-2a 180microg/week (subcutaneous injection) for 12 weeks. Patients with positive HCV
      RNA by qualitative PCR at the end of the 12 weeks treatment period will be offered to
      continue on the same regimen up to 24 weeks.
    

Intervention name(s): pegylated interferon alpha2a
Intervention type(s): Drug
Intervention MeSH terms: Interferons; Interferon-alpha; Interferon alpha-2; Peginterferon alfa-2a
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Acute hepatitis C; Genotype 4; Pegylated Interferon; Egypt
Fluid Management Guided by Bioimpedance Analysis in Peritoneal Dialysis(PD) Patients.
Condition: End Stage Renal Disease
MeSH terms: Kidney Failure, Chronic
Study type: Interventional

Summary: 
      1. Purpose: to investigate the effect of bioimpedance analysis(BIA) guided fluid management
           versus experiential way on clinical outcome in peritoneal dialysis patients.

        2. Design: prospective,randomized,controlled,single center study

        3. Study hypothesis: Patients on peritoneal dialysis are frequently hypervolemic, which is
           associated with increasing hazard of death and cardiovascular events. Bioimpedance
           analysis is a safe, and easy way, which appears to be more useful and sensitive than
           other techniques for assessing volume status in dialysis patients. Therefore we
           hypothesize that more concise and strict fluid management guided by BIA may help to
           improve patients' survival, decrease cardiovascular events and hospitalization rate.

        4. Objects: incident and prevalent patients with overhydration status.

             1. anticipated cases:240

             2. arms: all the patients are randomized into two arms.(BIA group/clinical group)

             3. observational time:12 months

        5. Primary Outcome: all cause mortality. Secondary Outcomes: technique survival,
           cardiovascular events, peritonitis, residual renal function.
    


Intervention name(s): bioimpedance monitoring; clinical monitoring
Intervention type(s): Device; Other
Intervention description(s): To assess the body composition using Multi-frequency bioelectrical impedance analysis; clinical symptom and examination,such as edema, body weight, blood pressure, cardial function
Other intervention name(s): Multi-frequency bioelectrical impedance analysis; Body Composition Analyzer; routine method of assessing water status
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Peritoneal Dialysis; fluid overload; bioimpedance analysis; Randomized Controlled Trial
Comparing Five Oral Analgesics for Treatment of Acute Pain in the Emergency Department (ED)
Condition: Musculoskeletal Pain
MeSH terms: Musculoskeletal Pain; Emergencies
Study type: Interventional
Phase: Phase 2

Summary: 
      This study compares the efficacy of five oral analgesics: 5 mg oxycodone + 325 mg
      acetaminophen, 5 mg hydrocodone + 300 mg acetaminophen, 30 mg codeine + 300 mg acetaminophen,
      400 mg ibuprofen + 1000 mg acetaminophen, and 800 mg ibuprofen + 1000 mg acetaminophen for
      the treatment of patients with acute musculoskeletal pain who present to the Emergency
      Department (ED).
    

Detailed description: 
      The optimal treatment of musculoskeletal extremity pain in the ED not known. The study is a
      randomized controlled trial designed to compare the efficacy of five oral analgesics: 5 mg
      oxycodone + 325 mg acetaminophen, 5 mg hydrocodone + 300 mg acetaminophen, 30 mg codeine +
      300 mg acetaminophen, 400 mg ibuprofen + 1000 mg acetaminophen, and 800 mg ibuprofen + 1000
      mg acetaminophen for the treatment of patients with acute musculoskeletal pain. The primary
      outcome is the between treatment group difference in change in patients' rating of pain
      intensity one hour after ingestion of the study medication. Secondary outcomes include: 1)
      the between treatment group difference in change in patients' rating of pain intensity two
      hours after ingestion of the study medication; 2) difference in proportion of patients who
      receive rescue medication; 3) difference in proportion of patients who would choose to take
      the study medication again if they returned to the ED with similar pain; 4) difference in
      proportion of patients who experience side effects.
    

Intervention name(s): oxycodone/APAP; hydrocodone/APAP; codeine/APAP; 400 ibuprofen/APAP; 800 ibuprofen/APAP
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): Oxycodone/acetaminophen 5 mg-325 mg oral tablet; Hydrocodone/Acetaminophen 5 Mg-300 Mg oral tablet; Codeine/acetaminophen 30 mg-300mg oral tablet; ibuprofen/acetaminophen 400 mg-1000mg oral tablet; ibuprofen/acetaminophen 800 mg-1000 mg oral tablet
Other intervention name(s): Percocet; Vicodin; Tylenol # 3; Motrin, Tylenol; Motrin, Tylenol
Intervention MeSH terms: Acetaminophen; Ibuprofen; Oxycodone; Hydrocodone; Codeine
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized controlled trial
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: acute pain; musculoskeletal pain; emergency medicine; Emergency Service, Hospital; analgesics; Acetaminophen; Ibuprofen; oxycodone; hydrocodone; codeine; adult
Study of Sildenafil in Patient With Heart Failure.
Condition: Congestive Heart Failure
MeSH terms: Heart Failure
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to determine if sildenafil (Viagra) improves exercise tolerance.
    

Detailed description: 
      Patients will undergo an exercise stress test. One dose of Sildenafil will then be given,
      followed by a one hour rest period. A repeat exercise stress test will then be repeated.
    

Intervention name(s): sildenafil
Intervention type(s): Drug
Intervention MeSH terms: Sildenafil Citrate
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Exercise stress test
A Pilot Test of t:Slim X2 With Control-IQ Technology
Condition: Type1 Diabetes Mellitus
MeSH terms: Diabetes Mellitus, Type 1
Study type: Interventional

Summary: 
      A 36-48 hour admission testing the t:slim X2 with Control-IQ Technology
    

Detailed description: 
      The objective of the study is for clinical staff to gain experience using the proposed
      artificial pancreas system named t:slim X2 with Control-IQ Technology and assess usability in
      a supervised setting prior to initiating home use in a Training protocol.
    

Intervention name(s): Tandem t:slim X2 with Control-IQ Technology
Intervention type(s): Device
Intervention description(s): Subjects will wear the Tandem t:slim X2 with Control-IQ Technology during a 36-48 hour hotel admission.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Artificial Pancreas (AP); Closed Loop Control (CLC); Continuous Glucose Monitor (CGM); Insulin Pump
A Phase II Trial to Assess the Safety and Immunogenicity of DNA Priming Administered by the ID Zetajet® With or Without ID Derma Vax™ Electroporation Followed by IM MVA Boosting in Healthy Volunteers in Tanzania and Mozambique
Condition: Vaccines; HIV; Safety; Immunogenicity
Study type: Interventional
Phase: Phase 2

Summary: 
      Electroporation will increase the efficiency of DNA priming in terms of immune responses and
      will lead to a dose sparing DNA vaccine regimen. Furthermore increased DNA vaccine
      concentration will reduce the number of shots necessary to deliver the full dose and induce
      comparable immune responses as with lower DNA vaccine concentrations.
    


Intervention name(s): HIVIS DNA vaccine; Zetajet; Derma Vax Electroporation; Modified Vaccinia Ankara (MVA-CDMR)
Intervention type(s): Biological; Device; Device; Biological
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Metformin Improves Clinical Pregnancy Rate in Polycystic Ovarian Syndrome Patients
Condition: Reproductive Endocrinology; Polycystic Ovarian Syndrome
MeSH terms: Polycystic Ovary Syndrome; Syndrome
Study type: Interventional
Phase: Phase 2

Summary: 
      Polycystic ovary syndrome (PCOS) is the most common Female endocrine disorder , with a
      prevalence ranging between 6% to10% based on the National Institutes of Health (NIH) criteria
      and when the broader Rotterdam criteria are applied it reaches as high as 15%. Typically,
      PCOS can identify during the early adolescence. Insulin resistance is a common finding in the
      obese women with PCOS. It is most prevalent and severe in PCOS phenotype involving
      hyperandrogenism and chronic anovulation. Women with PCOS who have regular cycles are
      metabolically less abnormal. Acanthosis nigricans (AN) is a dermatosis characterized by
      velvety, papillomatous, brownish-black, hyperkeratotic plaques, typically of the
      intertriginous surfaces and neck. Although AN is associated with malignancy, the recognition
      of its more common connection to obesity and insulin resistance allows for diagnosis of
      related disorders including type 2 diabetes, the metabolic syndrome, and polycystic ovary
      syndrome. Significant improvements in ovulation and pregnancy rates as a result of clomiphene
      treatment after metformin in women with clomiphene-resistant PCOS were reported in a popular
      randomized, double-blind, placebo-controlled trial . The first pharmacological approach to
      induction of ovulation in women with PCOS is clomiphene citrate
    


Intervention name(s): CC; Placebo tablets; Metformin
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 100 mg clomiphene Citrate (Clomid , global Napi , Egypt) CC tablets taken from day 3 to day 7 of the cycle; Placebo tablets taken twice daily continuously for three cycles.; wMetformin (Cidophage , Amon , Egypt) 500 mg twice daily continuously for three cycles.
Intervention MeSH terms: Metformin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Finnish Trial on Practices of Anterior Cervical Decompression (FACADE) Comparing Outpatient vs. Inpatient Care
Condition: Cervical Radiculopathy
MeSH terms: Radiculopathy
Study type: Interventional

Summary: 
      FACADE is a prospective, randomized, controlled, parallel group non-inferiority trial
      comparing the traditional hospital surveillance (inpatient, patients staying in the hospital
      for 1-3 nights after surgery) to outpatient care (discharge on the day of the surgery,
      usually within 6-8 hours after procedure) in patients who have undergone anterior cervical
      decompression and fusion (ACDF) procedure.
    

Detailed description: 
      To determine whether early discharge (outpatient care) is noninferior to inpatient care, the
      investigators will randomize 104 patients to these two groups and follow them for 6 months
      using the Neck Disability Index (NDI) as the primary outcome. The investigators expect that
      early discharge is not significantly worse (inferior) than the current care in terms of
      change in NDI. Noninferiority will be declared if the mean improvement for outpatient care is
      no worse than the mean improvement for inpatient care, within statistical variability, by a
      margin of 17.3%. The investigators hypothesize that a shorter hospital stay results in more
      rapid return to normal daily activities, shorter duration of sick leave and decreased
      secondary costs to health care system. Secondary outcomes in the study are arm pain and neck
      pain using the Numeric Rating Scale, operative success (Odom's criteria), patient's
      satisfaction to treatment, general quality of life (EQ-5D-5L), work ability score (WAS),
      sickness absence days, return to previous leisure activities, and complications.

      Patients who are eligible for the trial, but are not willing to undergo randomization, will
      be asked to be included in a simultaneous, pragmatic follow-up cohort.
    

Intervention name(s): Discharge on the day of surgery
Intervention type(s): Procedure
Intervention description(s): Patient discharge on the day of the surgery, usually within 6-8 hours after procedure
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Anterior cervical decompression and fusion; cervical fusion; cervical spine; spinal surgery; outpatient care; randomized controlled trial; Protocol