bioihbjkbjnl/mcl2 huggingface dataset:
Effect of Palm Olein Intake on Lipid Profile and Appetite Regulation
Condition: Lipidaemia
MeSH terms: Hyperlipidemias
Study type: Interventional

Summary: 
      Aims: To investigate whether acute ingestions of palm oil will have an effect on appetite
      regulation

      Design: A randomized, single blind, cross over design including 4 single study visits
      separated by a week. Visit 1 is an acclimatization visit followed by visit 2,3, and 4 where
      different types of fat will be given.

      Population: 12 healthy males and females aged between 18 and 60 years with body mass index
      (BMI) between 18.5- 29.9kg/m2 and normal fasting plasma glucose and no evidence of insulin
      resistance will be recruited. No-pre existing morbidity including cardiac, hepatic or renal
      disease, history of diabetes, hypertension or hyperlipidaemia.

      Treatment: Acclimatization visit: At visit 1, all participants will be given a milkshake like
      drink containing fat, protein and carbohydrate. A cannula will be inserted for the duration
      of the study day but no blood will be taken. Studies show than during the first visit stress
      response can affect the metabolic response to the study drink resulting in inaccurate
      results.

      Study visit 2,3,4: following the acclimatization visit, participants will attend 3 more study
      visits separated by a week to test the metabolic response to the following fats: palm olein,
      interesterified palm olein and soybean oil in random order. Participants will be asked to
      complete a visual analogue scale questionnaire about their appetite at each time point.
      Fasting and postprandial plasma glucose, insulin, appetite hormones and lipids will be
      measured.
    


Intervention name(s): Palm olein; Interesterified palm olein; Soybean oil
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): 60g of palm olein will be given in a milkshake at breakfast; 60g of interesterified palm olein will be given in a milkshake at breakfast; 60g of soybean oil will be given in a milkshake at breakfast
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Feasibility Study of Tai Chi for Cognitively Impaired Older Adults
Condition: Cognitive Impairment
MeSH terms: Cognitive Dysfunction
Study type: Interventional

Summary: 
      The goal of this clinical trial is to determine the feasibility of a 12-week program of Tai
      Chi for memory (TCM) among older adults with mild cognitive impairment (MCI) or dementia and
      to determine the effects of TCM on physical functioning, depression, and health-related QoL.
      Two experimental groups will be recruited for inclusion criteria of community-residing older
      adults with a diagnosis of either MCI or Dementia.
    

Detailed description: 
      The purpose of the study are to determine the acceptability of a 12-week program of Tai Chi
      for memory (TCM) among older adults with mild cognitive impairment (MCI) or dementia; and to
      determine the effects of TCM on physical functioning, depression, and health-related QoL.

      A quasi-experimental design was used with two groups classified according to the level of
      their cognitive impairment (MCI vs. Dementia).

      Depression, health-related QoL, and physical functioning including grip strength, balance,
      flexibility, and mobility were measured before and after the 12-week TCM program.

      Depression was measured using the Korean version of the Geriatric Depression Scale.

      Health-related QoL was measured using the 12-item Short Form survey (SF-12). Grip strength
      was assessed using a digital hand dynamometer. Flexibility was assessed using the standard
      sit-and-reach test. Balance was measured using the one-leg-standing balance test. Mobility
      was assessed using the timed up and go test. Paired and independent t-tests will be used to
      compare the effects of TCM within and between groups.
    

Intervention name(s): Tai Chi for memory
Intervention type(s): Behavioral
Intervention description(s): The adapted form of TCM will be provided at 60 minutes per session, twice a week for 12 weeks by a certified Tai Chi instructor who had experience in teaching older adults with cognitive impairments.
Intervention model: Single Group Assignment
Intervention model description: two intervention groups (1) those with MCI (2) those with dementia
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Tai Chi; cognitive impairment; dementia
Sacral Nerve Stimulation for Anal Incontinence and Bowel Control
Condition: Fecal Incontinence and Constipation
MeSH terms: Fecal Incontinence; Constipation
Study type: Interventional
Phase: Phase 4

Summary: 
      Multicenter European study to evaluate efficacy and safety of sacral nerve stimulation with
      InterStim Therapy to treat fecal incontinence or constipation
    


Intervention name(s): Type: Implantable neurostimulator; InterStim
Intervention type(s): Device
Intervention description(s): Treatment with InterStim Therapy: all patients meeting inclusion/exclusion criteria undergo test screening and those who have successful outcomes receive a permanent implant.
Other intervention name(s): InterStim Model 3023; InterStim Model 3058
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Slow transit constipation; Fecal incontinence; Constipation; Idiopathic slow transit constipation; Chronic constipation
Randomized Comparison of xiEnce and visioN Coronary Stents in the sAme muLtivessel Patient With Chronic kiDnEy diSease
Condition: Chronic Kidney Disease; Multivessel Coronary Artery Disease
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic; Coronary Artery Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      Percutaneous coronary intervention (PCI) with bare metal stent (BMS) in patients with renal
      insufficiency has shown unsatisfactory results. Indeed, drug-eluting stents (DES) might
      reduce the incidence of restenosis and therefore of target lesion revascularization
      procedures in these patients.

      We therefore designed a prospective, randomized, multicenter, not-sponsored study to directly
      compare the efficacy in the prevention of clinical restenosis of everolimus-eluting stent
      (Xience V) and bare-metal stent (Vision) (both 2nd-generation DES and BMS, respectively),
      both implanted in the same patient with multivessel disease and renal insufficiency in order
      to obviate for the multiple and unpredictable characteristics of this high-risk population.
    


Intervention name(s): Coronary stent
Intervention type(s): Device
Intervention description(s): Comparison of bare-metal stent (Vision) and drug-eluting stent (Xience V)
Other intervention name(s): Bare metal stent Vision; Drug-eluting stent Xience V
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Percutaneous coronary intervention; Drug-eluting stent; Chronic kidney disease; Restenosis
A Long-Term Safety Study of Tenapanor for the Treatment of IBS-C
Condition: Constipation Predominant Irritable Bowel Syndrome
MeSH terms: Irritable Bowel Syndrome; Syndrome; Constipation
Study type: Interventional
Phase: Phase 3

Summary: 
      This phase 3, open label study will evaluate the safety of tenapanor 50 mg BID in subjects
      with constipation-predominant irritable bowel syndrome (IBS-C) defined by the ROME III
      criteria. Subjects who have completed either TEN-01-301 (16 weeks) or TEN-01-302 (26 weeks)
      studies may be enrolled. Subjects will take tenapanor for approximately 52-55 weeks total
      based on previous protocol and this study.
    

Detailed description: 
      During the treatment period of up to 39-weeks, subjects will return for study visits
      approximately every 13 weeks. Subjects will undergo safety assessments at these visits, which
      may include a physical exam, ECG, vital signs, and clinical labs. Adverse events and
      concomitant medications will be recorded. Medication compliance will be monitored and the
      subjects will be given additional study drug as appropriate.
    

Intervention name(s): Tenapanor
Intervention type(s): Drug
Other intervention name(s): RDX5791; AZD1722
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Sunitinib in Treating Patients With Progressive Metastatic Transitional Cell Cancer of the Urothelium
Condition: Bladder Cancer; Transitional Cell Cancer of the Renal Pelvis and Ureter; Urethral Cancer
MeSH terms: Urinary Bladder Neoplasms; Carcinoma, Transitional Cell; Urethral Neoplasms; Kidney Neoplasms; Ureteral Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      RATIONALE: Sunitinib may stop the growth of tumor cells by blocking some of the enzymes
      needed for their growth and by blocking blood flow to the tumor.

      PURPOSE: This phase II trial is studying how well sunitinib works in treating patients with
      progressive metastatic transitional cell cancer of the urothelium.
    

Detailed description: 
      OBJECTIVES:

      Primary

        -  Determine the response rate in patients with progressive metastatic transitional cell
           carcinoma of the urothelium treated with sunitinib malate.

        -  Determine the safety of this regimen in these patients.

      Secondary

        -  Determine the time to disease progression in patients treated with this regimen.

             -  To determine time to tumor progression (TTP) for sunitinib malate on a continuous
                dosing schedule for treatment of metastatic urothelial carcinoma.

             -  To estimate sunitinib and SU012662 trough plasma concentration (Ctrough) data for
                the continuous daily schedule and to determine potential association with efficacy
                and safety.
    

Intervention name(s): sunitinib malate
Intervention type(s): Drug
Intervention MeSH terms: Sunitinib
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: recurrent bladder cancer; stage IV bladder cancer; transitional cell carcinoma of the bladder; anterior urethral cancer; posterior urethral cancer; recurrent urethral cancer; metastatic transitional cell cancer of the renal pelvis and ureter; recurrent transitional cell cancer of the renal pelvis and ureter; urethral cancer associated with invasive bladder cancer
EFFECT ON QUALITY OF LIFE AFTER PROSTATECTOMY
Condition: PROSTATECTOMY; URINARY INCONTINENCE
MeSH terms: Urinary Incontinence; Enuresis
Study type: Interventional

Summary: 
      Aim: This study was conducted to determine the effect of pelvic floor exercises (PTE) on
      urinary incontinence and quality of life (QOL) after radical prostatectomy (RP).

      Methods: This randomized controlled, single-blind, experimental study was completed with a
      total of 33 RP patients, 18 of whom were interventions, and 15 were controls. The
      intervention group was given pelvic floor exercises (PTE) training in the preoperative
      period, regular PTE was performed three times a day for six months in the postoperative
      period, and the continuity of the exercises was checked by telephone. On the other hand, no
      intervention was applied to the control group other than routine treatment.
    


Intervention name(s): PELVIC FLOOR EXERCISES
Intervention type(s): Other
Intervention description(s): Regular Pelvic floor exercises was performed three times a day for six months in the postoperative period
Other intervention name(s): Intervention Group
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Health Services Research
Keywords: Radical Prostatectomy; Pelvic Floor Exercises; Urinary Incontinence; Quality of life
Randomized Study on Endometrioma Treatment
Condition: Ovarian Endometrioma
MeSH terms: Endometriosis
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a randomised study comparing the effect of two laparoscopic techniques for treatment
      of ovarian endometriomas on recurrence rate and ovarian reserve.
    


Intervention name(s): Laser treatment of ovarian endometrioma
Intervention type(s): Procedure
Intervention description(s): Laser vaporization of ovarian endometrioma
Intervention model: Parallel Assignment
Promoting Safety Behaviours in Antenatal Care Using a Video
Condition: Intimate Partner Violence
Study type: Interventional

Summary: 
      This study investigates the effect of a video which teaches 15 safety behaviours for women
      subject to intimate partner violence (IPV) during pregnancy. Half of the women screening
      positive for IPV during pregnancy will view the intervention video. The other half will view
      a control video.
    

Detailed description: 
      Intimate partner violence (IPV) poses a risk for the health of the woman during pregnancy
      also for the health of the unborn child. Pregnancy is time when nearly all women have regular
      contact with the healthcare system. Pregnancy is also a time during which women consider
      their situation and are open for change.

      Healthcare staff have the opportunity to ask pregnant women if they experience IPV and need
      to know how to respond to women experiencing IPV. Healthcare staff can refer to other
      services. If staff are uncertain if referral is needed or wanted they can teach women how to
      increase their own safety and prepare for leaving through a number of safety promoting
      behaviours.The safety behaviours were originally developed in the USA to counsel women who
      attended a family violence unit and qualified for a protection order.

      Women do not always disclose the true nature of their IPV to staff. However, they could still
      benefit from learning about safety promoting behaviours. Using a video for teaching allows
      for the use of pictures and sound and options for several languages.
    

Intervention name(s): Safety behaviour promoting video; Control video
Intervention type(s): Behavioral; Behavioral
Intervention description(s): A 7 min. video which teaches 15 different safety behaviours to reduce violence or the effect of violence; A 7 min. video which teaches women about safety regarding food, alcohol, smoking, medication and physical activity during pregnancy
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Pregnant women will be screened for IPV using a modified version of the Abuse Assessment Screening. Women who screen positive are randomized into either the intervention video or a control video. Women screening negative for violence will be shown the control video. All women receive standard care and a card with high quality websites about safe pregnancy. Hidden among these is a webside that informs women about IPV (rights, safety etc..). Three months after birth all the women screening positive for violence will receive another questionnaire to fill out. In addition will a random sample of women who screened negative for IPV be asked to fill out a questionnaire at the same time. This group will be double the size of the women screening positive.
Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: IPV
Study on Sodium and Caffeine in Children and Adolescents
Condition: Sodium; Caffeine
Study type: Observational

Summary: 
      This study will compare different methods (24 hour urine collection, evening and morning
      spots, and questionnaires) to measure the consumption of sodium and cafeine in children and
      adolescents.
    

Detailed description: 
      Sodium consumption among adults is high in Switzerland, as in most parts of the world. It is
      expected to be high in children as well, but little is still known. 24 hour urine collection
      is the golden standard to assess sodium consumption. However, this method is logistically
      difficult, especially for children. Therefore, alternatives are needed. Urinary spots have
      been used as a proxy to estimate sodium excretion over 24 hour in adults, but not in
      children. This study will assess whether urinary spots can be used to estimate sodium
      consumption in children in comparison to 24 hour urine collections.

      Caffeine consumption has risen in children over the past years, mainly before of the increase
      in consumption of soda drinks. A precise way to measure caffeine consumption is by assessing
      the concentration of caffeine and its metabolites in 24 hour urine samples. An alternative to
      24 hour urine collection is using questionnaires, however this remains difficult due to the
      multiples food sources of caffeine. This study will compare caffeine consumption estimated by
      24 hour urine collection and by a semi-quantitative food frequency questionnaire targeting
      caffeine containing products.
    

Intervention name(s): No intervention
Intervention type(s): Other
Intervention description(s): This study is observational and does not entail any intervention. Different methods to assess sodium and caffeine consumption will be compared.
Observational model: Other
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Children between 6 and 16 years of age, following ambulatorily at the Hospital of Sion
      
Biospecimen description: 
      Urine samples
A Trial of the Efficacy and the Safety of RO6889450 (Ralmitaront) vs Placebo in Patients With an Acute Exacerbation of Schizophrenia or Schizoaffective Disorder
Condition: Schizophrenia, Schizoaffective Disorder
MeSH terms: Schizophrenia; Psychotic Disorders
Study type: Interventional
Phase: Phase 2

Summary: 
      This study will investigate the efficacy and safety of RO6889450 as monotherapy in
      participants experiencing an acute exacerbation of symptoms of schizophrenia or
      schizoaffective disorder.
    


Intervention name(s): RO6889450; Placebo; Risperidone
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Participants will receive oral RO6889450 QD.; Participants will receive oral placebo QD.; Participants will receive oral risperidone QD.
Intervention MeSH terms: Risperidone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Expectancy as Alternative to Treatment for Cervical Intraepithelial Neoplasia Grade 2 Among Women 25 - 30 Years of Age
Condition: CIN2; Therapy
MeSH terms: Uterine Cervical Dysplasia
Study type: Interventional

Summary: 
      In the Swedish organised cervical screening program precursors of cervical cancer are
      detected and treated. Most precursor lesions detected by screening heal spontaneously. Those
      who progress do it slowly. There are three levels from light; CIN1, moderate; CIN2 to severe;
      CIN3. Women with CIN3 are always treated, regardless of age, according to current clinical
      guidelines. Women with CIN2 who are below the age of 25 years are offered active expectance
      for up to two years because there is good evidence that they will spontaneously heal their
      lesions (regression) in 40-70% of the cases during that time.

      Method of treatment is today an excisional procedure of the cervix most often by Large loop
      excision of the transformation zone (LLETZ/LEEP) Treatment increases the risk of premature
      birth in a future pregnancy. In 2015 about 1800 excisional procedures of the transformation
      zone of the cervix were performed in the Västra Götalands regionen (VGR) om Sweden. The
      average age of first-time mothers in Sweden is rising and in 2014 it was 29 years. Postponed
      childbearing raises the question whether it is possible to refrain from surgery even for the
      group of women over 25 years old, with proven CIN2. Existing studies suggest that cure of
      CIN2 in the age group of and above 25 takes place in the same extent as under 25 years of
      age.There is lack of evidence concerning clinical follow-up.

      In a prospective multicenter clinical cohort study (observational study) with careful
      monitoring, the investigators will examine what proportion of CIN2 changes regress
      spontaneously within two years in women, 25-30 years old, and if human papillomavirus (HPV)
      type 16 may can be a marker for poor regression in this group. Instead of LLETZ, active
      expectance is offered to women this age with CIN2 in five gynecological clinics in VGR. The
      study protocol includes gynecologist visits every 6 months for two years, including cytology,
      colposcopy and directed biopsies of the cervix. Power calculation shows 160 women needs to be
      included, which is expected to occur within one year from the start.
    

Detailed description: 
      Available in Swedish
    

Intervention name(s): Expectancy
Intervention type(s): Procedure
Intervention description(s): Clinical monitoring. See arm description
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: neoplasm; uterine cervix
A Study to Evaluate the Immunogenicity and Safety of Seqirus Quadrivalent Influenza Vaccine (QIV) in a Pediatric Population 5 Through 17 Years of Age
Condition: Influenza, Human
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a study to assess the immune (antibody) response and safety of a Seqirus split
      virion, inactivated Quadrivalent Influenza Vaccine (Seqirus QIV), in comparison with a US
      licensed 2015/2016 Quadrivalent Influenza Vaccine (comparator QIV) in a healthy pediatric
      population 5 through 17 years of age.
    


Intervention name(s): Seqirus QIV; Comparator QIV
Intervention type(s): Biological; Biological
Intervention description(s): Seqirus QIV, inactivated, split-virion, thimerosal-free, quadrivalent influenza vaccine, administered as a 0.5 mL intramuscular dose. The vaccine is presented in a prefilled needleless syringe.
The subject's age and influenza vaccination history determines the dosing regimen (a single vaccination or a 2-vaccination regimen administered 28 days apart) according to the most recent US ACIP guidelines for seasonal influenza vaccination.; The US-licensed Comparator QIV, inactivated, split-virion, thimerosal-free, quadrivalent influenza vaccine, administered as a 0.5 mL intramuscular dose. The vaccine is presented in a prefilled needleless syringe.
The subject's age and influenza vaccination history determines the dosing regimen (a single vaccination or a 2-vaccination regimen administered 28 days apart) according to the most recent US ACIP guidelines for seasonal influenza vaccination.
Other intervention name(s): Fluarix Quadrivalent
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention