bioihbjkbjnl/mcl2 huggingface dataset:
CYP3A4 Activity and Mineral Homeostasis
Condition: Vitamin D and Calcium Homeostasis
Study type: Interventional
Phase: Early Phase 1

Summary: 
      The purpose of this study is to determine whether changes in the activity of the enzyme
      CYP3A4 can change the Vitamin D and bone mineral homeostasis.
    

Detailed description: 
      Healthy volunteers will receive one of six interventions for 14 days (determined by
      randomization):a). 200 mL of water once a day; b) rifampin 600 mg once a day; c) 200 mL of
      grapefruit juice once a day for 8 days plus rifampin 600 mg once a day for 14 days; d)
      clarithromycin 250 mg twice a day; f) clarithromycin 250 mg twice a day plus rifampin 600 mg
      once a day.
    

Intervention name(s): Rifampin; Clarithromycin; Grapefruit Juice; Placebo
Intervention type(s): Drug; Drug; Other; Other
Intervention description(s): P450 inducer; CYP3A4 and Pgp inhibitor in both intestine and liiver; CYP3A4 inhibitor in intestine
Other intervention name(s): Rifadin; Biaxin
Intervention MeSH terms: Clarithromycin; Rifampin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Vitamin D; CYP3A4; Calcium
Clinical Trial of Rasagiline in Levodopa-Treated Parkinson's Disease Patients With Motor Fluctuations
Condition: Parkinson´s Disease
MeSH terms: Parkinson Disease
Study type: Interventional
Phase: Phase 3

Summary: 
      The objective of this study is to evaluate the efficacy, tolerability, and safety of
      rasagiline compared to placebo in PD patients with motor fluctuations on levodopa therapy.
    

Detailed description: 
      Levodopa has been the mainstay therapy for PD for decades, and it is considered to be one of
      the most effective medications for relief of the symptoms of PD. However, within few months
      to few years the majority of levodopa-treated patients notice a decline in the duration of
      benefit of each dose and develop motor-complications. A major problem is the appearance of
      fluctuations in mobility, cycles of ON and OFF periods. The administration of rasagiline, a
      MAO-B inhibitor, can slow the elimination of the endogenous dopamine supplies or the dopamine
      produced from the exogenous levodopa therapy and may therefore improve ON-OFF fluctuations.

      The objective of this study is to evaluate the efficacy, tolerability, and safety of
      rasagiline compared to placebo in PD patients with motor fluctuations on levodopa therapy.
    

Intervention name(s): Rasagiline; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Tablets, qd; Tablets, qd
Other intervention name(s): Azilect
Intervention MeSH terms: Rasagiline
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Motor fluctuations; Parkinson´s Disease; Rasagiline
Comparative Study Between Surgical and Non Surgical Treatment of Anismus in Patients
Condition: Obstructed Defecation; Anismus; Constipation
MeSH terms: Constipation
Study type: Interventional

Summary: 
      Comparative study between surgical and non surgical treatment of anismus in patients with
      symptoms of obstructed defecation.

      Anismus is a significant cause of chronic constipation. This study came to compare the
      results of BFB training , BTX-A injection and PDPR in the treatment of anismus patients.
      Patients and methods: Seventy two anismus patients fulfilled Rome II criteria for functional
      constipation were included in this study. All patients underwent anorectal manometry, balloon
      expulsion test, defecography, and electromyography activity of the EAS. All patients had non
      relaxing puborectalis muscle.. The patients were randomized into three groups. Group I
      patients received biofeedback therapy, two times per week for about 1 month. Group II
      patients were injected with BTX- A. Group 111 partial division of puborectalis was done.
      Follow up was conducted weekly in the first month then monthly for about 1 year.
    

Detailed description: 
      Key words:

      Obstructed defecation, chronic constipation, puborectalis, pelvic floor
    

Intervention name(s): BFD; PDPR; BTX A
Intervention type(s): Other; Procedure; Other
Intervention description(s): The investigators used pressure based biofeedback training, using a perfused eight-channel polyvinyl catheter with a compliant balloon at the tip; A 2-3 cm curved incision is made on either side of the anal canal along its posterolateral aspect, each about 2.5 cm distance from the anal verge Fig(2). After that dissection in ischiorectal fossa was done till reaching the puborectalis sling from outside i.e. extrasphincteric approach . Using a right angle forceps the puborectalis sling is lifted up, guided by the contralateral index finger in the anal canal Fig(3). Nearly the inner half of puborectalis sling was divided on each side by using a scalpel NO. 11 Fig(4). Complete haemostasis was followed by skin closure without drain; A vial of Dysport, 500 u, (Dysport, Ipsen, United Kingdom) is dissolved in 2.5 ml isotonic saline Fig(1). A volume of 0.5 ml of dissolved toxin, i.e., 100 u Dysport, is injected in each patient
Other intervention name(s): BIOFEEDBACK RETRAINING; PARTIAL DIVISION OF PUBORECTALIS; BOTILINUM TOXIN
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: obstructed defecation; constipation; puborectalis
A Website to Teach Children Safety With Dogs
Condition: Child Dog Bite Prevention
Study type: Interventional
Phase: Phase 1

Summary: 
      Dog bites result in over 800,000 doctor/ER visits, 6000 hospitalizations, and a dozen deaths
      each year in the United States. By a large margin, children suffer the highest risk - and
      children typically are bitten by familiar dogs in familiar places. Several programs exist to
      reduce pediatric dog bite risk, but few are empirically-supported or theoretically-motivated.
      None are widely disseminated. This study builds from existing child dog bite prevention
      programs to develop and then evaluate a website to teach children safe interactions with
      dogs. The website will be interactive, entertaining, and engaging, allowing children (target
      ages 4-6) to learn in a technologically-sophisticated and interactive environment. It will be
      developed based in behavioral theory. Hearkening child development theory, it will teach and
      permit practice of cognitive skills that develop in early childhood and are critical to
      safety with dogs: impulse control, perspective taking, and attention to details. Hearkening
      health behavior change theory, the website will help children and their parents perceive
      personal vulnerability to bites, recognize normative behavior to protect themselves, and have
      personal motivation to change previous habits. Overarching the website design will be goals
      to create an engaging and entertaining environment, and to facilitate cognitive and
      behavioral change on the part of both child and parent via multiple mechanisms. Besides
      teaching children, the website will educate parents via an innovative messaging system
      triggered by child attainment of points and "skill levels".

      Following website development, an evaluation study will investigate usability and efficacy of
      the website using a repeated measures pre-test, post-test experimental design. 68 children
      ages 4-6 will be recruited, complete a pre-intervention assessment evaluating knowledge and
      behavior relevant to dog safety via multiple methods, and then be randomly assigned to use
      either the newly-developed dog safety website or a control pedestrian safety website at home
      over the subsequent 2 weeks. Frequent reminders will encourage website use. Following the
      2-week period, all children will return for a post-intervention assessment battery to
      evaluate knowledge and behavior change. Data will be analyzed using descriptive and
      inferential statistics, with primary hypotheses tested using linear mixed models.
    


Intervention name(s): dog safety; transportation safety
Intervention type(s): Behavioral; Behavioral
Intervention description(s): use of dog safety website at home for about 2 weeks; use of transportation safety website at home for about 2 weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Evaluation of Changes in Pancreatic Fat Content Using Advanced MR Sequences in Diabetics on Dapagliflozin Therapy
Condition: Pancreatic Lipomatosis
MeSH terms: Lipomatosis
Study type: Interventional
Phase: Phase 4

Summary: 
      The study aimed to assess changes in pancreatic fat content in people with diabetes on
      dapagliflozin (SGLT2 inhibitor) and beta cell function.
    

Detailed description: 
      The study assessed and estimated the difference in pancreatic fat content in the patients of
      Type 2 Diabetes Mellitus at baseline and after taking dapagliflozin for 24 weeks.

      The investigators even estimated the correlation between two advanced MR techniques commonly
      used for quantification of pancreatic fat (PDFF and MR Spectroscopy)
    

Intervention name(s): Dapagliflozin 10mg Tab
Intervention type(s): Drug
Intervention description(s): Dapagliflozin was given at a dose of 10 mg/day in one group and its effect was observed on the pancreatic fat content
Intervention MeSH terms: Dapagliflozin
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomised Control Trial
Masking: Single (Investigator)
Primary purpose: Other
Keywords: Dapagliflozin; Pancreatic fat; MRI; Diabetes; MRS
Safety Study of Nexvax2 in Subjects With Coeliac Disease
Condition: Coeliac Disease; Celiac Disease
MeSH terms: Celiac Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      The main purpose of this study is to determine the safety of weekly injections of Nexvax2
      given for three weeks to patients with coeliac disease who have been on a gluten-free diet.

      The second purpose of this study is to compare the immune response over the three week study
      period in coeliac disease patients given Nexvax2 compared to those given saline.
    


Intervention name(s): 9 micrograms Nexvax2; 30 micrograms Nexvax2; 90 micrograms Nexvax2; 60 micrograms Nexvax2; Up to 900 micrograms Nexvax2; Placebo
Intervention type(s): Biological; Biological; Biological; Biological; Biological; Other
Intervention description(s): 9 micrograms, weekly intra-dermal injection, 3 week duration; 30 micrograms, weekly intra-dermal injection, 3 week duration; 90 micrograms, weekly intra-dermal injection, 3 week duration; 60 micrograms, weekly intra-dermal injection, 3 week duration; Up to 900 micrograms, weekly intra-dermal injection, 3 week duration; 100 microlitres 0.9% sterile sodium chloride for injection
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
The Effect of Massage on Growth And Stress And Stress ,Department of Nursing,
Condition: Preterm
MeSH terms: Premature Birth
Study type: Interventional

Summary: 
      The aim of this thesis is to exprementally investigate the effect of massage applied to
      preterm infants on growth and stress. While the population of the research is preterm infants
      at the neonatal intensive care unit of a Medicalpark Batman Hospital between January 2018 and
      February 2019, the sample is 60 preterm infants suitable for inclusion criteria. Research
      data was collected using Preterm Infant Information Form, Preterm Follow-up Form and Newborn
      Stress Scale. While massage was applied to the infants in the experimental group three times
      daily for 10 days, the control group received the usual care. Weight, length and head
      circumference of infants in both experimental and control group were measured by the
      researcher on 1., 5. and 10. days. In order to evaluate stess level of the massage applied
      infants, camera records of the infants were taken 15 minutes before and after the massage on
      1., 5. and 10. days. Camera records of the infants in the control group were also taken at
      the same time with those in the experimental group. Camera records were watched and stress
      level of the infants were evaluated by two observers blind to the research. The data analyses
      were carried out using In-class Correlation, Frequency, Levene, Two-Way ANOVA for Mixed
      Measured, Repeated ANOVA tests
    

Detailed description: 
      The aim of this thesis is to exprementally investigate the effect of massage applied to
      preterm infants on growth and stress
    

Intervention name(s): massage
Intervention type(s): Behavioral
Intervention description(s): stressn level and preterm growth
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: preterm
Combined Anesthesia for Labor and Maternal Temperature
Condition: Pyrexia; Abdominal Delivery
MeSH terms: Fever
Study type: Interventional
Phase: Phase 3

Summary: 
      Maternal intra-partum fever commonly complicates the process of labour. Its occurrence is
      often regarded as being synonymous with the presence of chorioamnionitis. This inevitably
      results in the administration of antibiotics to the affected mother. Review of the literature
      however suggests that this approach is not always appropriate. Non-infective causes of this
      condition that are often overlooked include the use of epidural analgesia for pain relief,
      normal thermal physiological changes in women not using any form of analgesia and delivery in
      an overheated room. Women with certain risk factors such as nulliparity and a long latent
      phase of labour are also more prone to developing maternal intra-partum fever. Irrespective
      of its aetiology, maternal intra-partum fever carries risks both for the mother and her
      unborn child. Putting more thought into the care of these patients will go a long way in
      reducing the maternal and neonatal morbidity associated with this complication.The combined
      spinal-epidural (CSE) technique has been introduced in an attempt to reduce these adverse
      effects. CSE is believed to during labour provide more rapid onset of analgesia than epidural
      analgesia, The incidence of fever is significantly lower with CSE technique.
    

Detailed description: 
      The objective this study is determine the fever maternal incidence with CSE technique for
      labor analgesia.

      METHODS: a randomized open clinical trial will be conducted involving Seventy healthy, term,
      nulliparous women in spontaneous labor were assigned to either CSE technique or non
      pharmacologic analgesia for labor.these patients will be randomly assigned to receive or not
      CSE technique for labor analgesia. Outcomes analysis wiil include maternal fever, pain
      intensity measured by visual analog scale, labor duration, c-section and instrumental
      delivery. statical analysis will performed using Mann-Whitney and Fisher" exact test 5% level
      of significance.
    

Intervention name(s): Combined epidural and spinal anesthesia
Intervention type(s): Drug
Intervention description(s): Obstetrics patients will relieve spinal anesthesia with local anesthesics and opioids associated with epidural anesthesia with local anesthetics in low concentrations with opioids
Other intervention name(s): Local anesthetics; spinal opioides
Intervention MeSH terms: Anesthetics; Anesthetics, Local
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Fever; anesthesia; Labor
Evaluate the Safety and Effectiveness of Electronic Vision-aid Device
Condition: the Blind
Study type: Interventional

Summary: 
      To evaluate the safety and effectiveness of electronic Vision-aid Device in walking and
      obstacle recognition for visually blind people
    


Intervention name(s): electronic Vision-aid Device
Intervention type(s): Device
Intervention description(s): Electronic blind aid is a non-invasive electronic aid product for the visually impaired. The product converts visual signals into tactile signals. The Vision Pro is designed for people with poor or no visual perception. The product does not change the previous travel mode of the visually impaired, and provides additional external information for the visually impaired on the basis of their existing cognition. The product can provide the visually impaired person with additional external information based on the cognition in front of them. The product can feedback the environmental information within 2.52.5 meters in front of the visually impaired person in the form of electrical stimulation to the visually impaired person. The visually impaired person can be stimulated by the tongue current to help them identify obstacles and give early warning. Avoid obstacles and give early warning.
Intervention model: Single Group Assignment
Intervention model description: The clinical trial was a prospective, single-group, uncontrolled design using the target value method
Three centers participated
A total of 36 patients were enrolled. It was developed and produced by Weikan Technology in subjects who agreed to be enrolled
The "Vision Pro" is trained, and after no less than 3 hours of training, the subject is good at it
Evaluate the safety and effectiveness of obstacle perception and recognition in the process of walking, and evaluate the test product in auxiliary sight
Safety and effectiveness of obstacle perception and recognition for disabled walkers.
Masking: None (Open Label)
Primary purpose: Supportive Care
Prevention of Postpartum Weight Retention in Low Income WIC Women
Condition: Obesity
MeSH terms: Gestational Weight Gain
Study type: Interventional

Summary: 
      This study will examine the effects of an online behavioral intervention to promote weight
      loss in low income postpartum women in the WIC program.
    

Detailed description: 
      This program is designed to reduce postpartum weight retention in low income women in the WIC
      program. The weight loss program will be delivered over the internet and will use behavioral
      weight loss techniques.
    

Intervention name(s): Online postpartum weight control
Intervention type(s): Behavioral
Intervention description(s): The intervention group will be given access to an online weight loss program supplemented by monthly group meetings.
Other intervention name(s): Internet-based treatment for weight loss
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Postpartum weight retention; Low income women; WIC; Online
Computerized Contraceptive Decision Aid
Condition: Contraception; Decision Making; Satisfaction; Evaluation
Study type: Interventional

Summary: 
      The purpose of this study is to conduct a randomized clinical trial of a web-based
      contraceptive decision aid compared to routine contraceptive counseling to evaluate the
      effect of the contraceptive decision aid on the contraceptive method selected by the
      participant.

      The investigators primary hypothesis is that women utilizing a computerized Contraceptive
      Decision Aid (CDA) will be more likely to choose highly effective contraception than women
      who undergo standard clinical contraceptive counseling.
    

Detailed description: 
      Our primary specific aim is to test the CDA by conducting a randomized clinical trial
      comparing the CDA to routine contraceptive counseling. Our primary outcome of interest will
      be selection of highly effective contraception including the intrauterine device (IUD), the
      implant, and injectable contraception compared to all other reversible contraceptive methods.

      We will also complete the following secondary specific aims:

        1. We will use the validated Decisional Conflict Scale to measure decisional conflict pre-
           and post-intervention and compare the change in decisional conflict score in women
           randomized to the CDA to women undergoing routine counseling.

        2. We will also evaluate satisfaction with contraceptive counseling and contraceptive
           continuation and satisfaction at 3 and 6 months.
    

Intervention name(s): CDM Tool
Intervention type(s): Other
Intervention description(s): Participants will be required to complete the CDM tool and receive a tailored print out of their contraceptive options based on survey answers
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Clinical Test of Blood Glucose Test Strips
Condition: Diabetes
Study type: Interventional

Summary: 
      Blood glucose test strips are tested with the test meters to test the accuracy of the blood
      pressure monitoring function.
    


Intervention name(s): blood glucose monitor
Intervention type(s): Device
Intervention description(s): Blood glucose monitor is used to monitor the blood glucose level of the human-being.
Other intervention name(s): Andon or lifescan blood glucose monitor
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: blood glucose