bioihbjkbjnl/mcl2 huggingface dataset:
Cognitive Bias Modification (CBM) and Internet Cognitive Behavioural Therapy (iCBT) for Depression- A Randomised Controlled Trial
Condition: Depression
MeSH terms: Depression; Depressive Disorder
Study type: Interventional

Summary: 
      Cognitive accounts of depression and anxiety emphasize the importance of cognitive biases in
      the maintenance of disorders. One specific bias is the interpretation of ambiguous
      information. A negative interpretation bias is defined as a systematic tendency to interpret
      potentially ambiguous information in a negative rather than benign way and this bias has been
      associated with symptoms of depression. Research has led to the recent development of
      computerized cognitive bias modification (CBM) techniques to augment such biases and it has
      been suggested that CBM techniques may be useful as an adjunct to current treatments to
      enhance maintenance of treatment gains and minimize relapse rates. The fact that CBM
      procedures lend themselves to being delivered remotely, are cost-effective, and can be
      self-paced in ways that suit the patient make them an ideal candidate for inclusion in the
      Internet-based cognitive behavioural therapy (iCBT) programs currently offered through St.
      Vincent's Hospital and the University of New South Wales. Therefore, the primary aim of the
      current trial is to evaluate the acceptability and effectiveness of adding CBM procedures to
      the existing iCBT modules offered through St. Vincent's Hospital and the University of New
      South Wales. It is expected that iCBT + CBM will result in superior treatment outcomes as
      indexed by a standardized clinical battery.
    


Intervention name(s): OxIGen + iCBT; Waitlist Control
Intervention type(s): Other; Other
Intervention description(s): OxIGen is an Internet-based intervention taking place over 1 week followed by iCBT, an Internet-based treatment for depression taking place over 10 weeks.; Waitlist will receive iCBT at week 11
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Deoxycholic Acid Injection Submental Fat (SMF) Magnetic Resonance Imaging (MRI) and Subject-reported Outcome Measures Study
Condition: Moderate or Severe Submental Fullness
Study type: Interventional
Phase: Phase 2

Summary: 
      Evaluation of the safety, tolerability and efficacy of deoxycholic acid injection in the
      reduction of submental fat (fat below the chin).
    


Intervention name(s): Deoxycholic acid injection; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Phosphate buffered saline placebo for injection
Other intervention name(s): ATX-101; Kybella
Intervention MeSH terms: Deoxycholic Acid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
An Observational Study of Statin Treatment Induced HDL Changes
Condition: Cardiovascular Disease
MeSH terms: Cardiovascular Diseases
Study type: Observational

Summary: 
      The aim with this study is to investigate the effect of statin induced changes in HDL-C on
      all cause mortality and CVD with adjustment for changes in other blood lipids and clinical
      parameters in Sweden, UK and the Netherlands.
    

Detailed description: 
      An observational study of statin treatment induced HDL changes - effect on cardiovascular
      disease
    

Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Patients who received a first prescription of a statin (ATC code C10AA) between 1st of
        January 2004 and 31st of December 2010. Swedish data will be extracted from medical records
        and national registers and for UK and the Netherlands from central registers.
      
Biospecimen description: 
      Cholesterol values (HDL-C, LDL-C, TC)
    
Keywords: Statin treatment; Cardiovascular disease; Statin treatment induced HDL changes and the effect on cardiovascular disease
Stroke Volume Variation vs Central Venous Pressure Guidance Fluid Management in Endovascular Aortic Repair
Condition: Postoperative Complications
MeSH terms: Postoperative Complications
Study type: Interventional

Summary: 
      Hypothesis: Fluid management guided by stroke volume variation (SVV), compared with central
      venous pressure (CVP), guidance results in better clinical outcomes.

      Primary outcomes: Perioperative, up to 48 h postoperative, serum lactate and creatinine
      level.

      Methods: Adult patients undergoing endovascular aortic aneurysm repair (EVAR) will be
      randomized into 2 groups: SVV group managed by SVV guidance and CVP group managed by CVP
      guidance.

      Outcome analyses: Compare serum lactate, creatinine as well as other postoperative
      complications between both groups.
    

Detailed description: 
      Objective: To compare postoperative clinical outcome in adult patient undergoing EVAR.

      Primary outcome: Postoperative serum lactate and creatinine.

      Secondary outcome: Postoperative complications.

      Methods: Eligible patients will be randomized to 2 groups. Both groups will be managed
      intraoperatively in the same way, except fluid management protocol. SVV group will be managed
      according to stroke volume variation (SVV) protocol, i.e., control SVV 10-13% and give fluid
      when SVV > 13%. CVP group will be managed using central venous pressure (CVP) protocol, i.e.,
      control CVP 8-12 mmHg and give fluid when CVP < 8 mmHg.

      Outcome analyses: Postoperative serum lactate and creatinine of both groups will be compared
      using unpaired Student-t test. Secondary outcomes will be compared using chi-square test.
    

Intervention name(s): Fluid management protocol
Intervention type(s): Procedure
Intervention description(s): SVV protocol: keep SVV 10-13% and give fluid when SVV > 13% CVP protocol: keep CVP 8-12 mmHG and give fluid when CVP < 8 mmHg
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Group SVV: fluid management guided by stroke volume variation (SVV) protocol Group CVP: fluid management guided by central venous pressure (CVP) protocol
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: stroke volume variation; central venous pressure; serum lactate; serum creatinine
Time Based Effects of Different Duration Stretching on Calf Muscle Strength
Condition: Muscle Strength
Study type: Interventional

Summary: 
      Stretching is reported to decrease muscle strength and thus suggested to be avoided prior to
      athletic events but with conflicting reports. This time course study aimed to assess acute
      effects of static stretching of different durations on isometric maximum voluntary
      contraction force of calf muscle.
    

Detailed description: 
      Stretching is reported to decrease muscle strength and thus suggested to be avoided prior to
      athletic events but with conflicting reports. This time course study aimed to assess acute
      effects of static stretching of different durations on isometric maximum voluntary
      contraction force of calf muscle. Pretest posttest experimental design was used. 14 subjects
      participated in three experimental trials: Static stretching for 2 minutes (SS2), static
      stretching for 4 minutes (SS4), and static stretching for 8 minutes (SS8). Strength was
      measured before (pre), immediately after (post), and at 10- and 20- minutes post stretching.
      Each static stretching (SS) trial involved varied repetitions of 30-seconds self-stretches
      and 20-seconds relax periods.
    

Intervention name(s): Muscle Static Stretching
Intervention type(s): Other
Intervention description(s): Static stretching for 2 minutes (SS2), static stretching for 4 minutes (SS4), and static stretching for 8 minutes (SS8). Each static stretching (SS) trial involved varied repetitions of 30-seconds self-stretches and 20-seconds relax periods.
Intervention model: Single Group Assignment
Intervention model description: Subjects participated in three experimental trials: Static stretching for 2 minutes (SS2), static stretching for 4 minutes (SS4), and static stretching for 8 minutes (SS8). Strength was measured before (pre), immediately after (post), and at 10- and 20- minutes post stretching.
Masking: None (Open Label)
Primary purpose: Other
Keywords: Muscle strength; muscle stretching exercises; Calf Muscle
Increasing Potassium Intake in Hypertensive Individuals
Condition: Hypertension
MeSH terms: Hypertension
Study type: Interventional

Summary: 
      This study evaluates the safety of increasing dietary potassium intake in a hypertensive
      population that may be at risk for hyperkalemia.
    

Detailed description: 
      The blood pressure lowering benefits of increasing dietary potassium (K⁺) are well known. As
      such dietary recommendations for hypertension focus on a diet rich in high K⁺ food sources
      such as fruits and vegetables. An important theme to be addressed is the safety of achieving
      high dietary K⁺ intake in hypertensive individuals who are also receiving medical therapy
      that might predispose to elevated serum K⁺ levels (hyperkalemia).

      The purpose of this study was to assess the impact of aggressively increasing dietary K⁺ on
      serum K⁺ concentrations in hypertensive individuals with intact renal function medicated with
      RAAS blocking drugs. The investigators hypothesized that dietary K⁺ supplementation would not
      provoke hyperkalemia despite treatment with either an angiotensin converting enzyme (ACEi) or
      an angiotensin receptor blocker (ARB).

      The investigators conducted an open controlled clinical trial in 20 hypertensive subjects
      with normal renal function who were randomized to a usual diet group (UD n=10), or a high
      potassium diet group (HKD, n= 10). Fruits and vegetables were used to increase potassium
      intake. All participants were on an ACEi or and ARB. Serum potassium concentration, 3- day
      food records and 24 Hour urine collections were completed at baseline and at the end of the
      4-week study.
    

Intervention name(s): High potassium diet
Intervention type(s): Other
Intervention description(s): An increase in consumption of high potassium fruits and vegetables
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Nutrition; Potassium
Preoperative Alignment of Total Knee Replacement
Condition: Knee Arthritis
MeSH terms: Arthritis
Study type: Interventional
Phase: Phase 3

Summary: 
      The hypothesis of this study is that total knee alignment will be improved by preoperative
      planning from CT scans and the production of custom instruments compared to the use of
      standard instruments.
    

Detailed description: 
      Patients will be randomized to have either customized knee instruments or standard generic
      instrumentation for primary total knee replacement. Postoperative CT scan will be used to
      determine alignment of each group.
    

Intervention name(s): trumatch group; control group
Intervention type(s): Procedure; Procedure
Intervention description(s): these patient will have CT based customized knee instruments used for surgery; these patients will have standard instrumentation used for for knee replacement
Other intervention name(s): trumatch CPI; Depuy knee instruments
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: alignment
"Six-week Study of the Safety and Efficacy of JZP-110 in the Treatment of Excessive Sleepiness in OSA"
Condition: Obstructive Sleep Apnea
MeSH terms: Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Sleepiness
Study type: Interventional
Phase: Phase 3

Summary: 
      This trial is a 6-week, double-blind, placebo-controlled, randomized-withdrawal, multicenter
      study of safety and efficacy of JZP-110 in the treatment of excessive sleepiness in adult
      subjects with OSA.
    


Intervention name(s): JZP-110
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Dexmedetomidine to Improve Outcomes During Emergence From Retroperitoneal Laparoscopic Surgery
Condition: Anesthesia
Study type: Interventional

Summary: 
      The study is to observe whether dexmedetomidine could reduce agitation during emergence from
      general anesthesia in patients undergoing retroperitoneal laparoscopic surgery.
    

Detailed description: 
      Agitation during emergence is frequent after retroperitoneal urologic surgery.
      Dexmedetomidine is alpha-2 receptor agonist which shows sedative and algesic effect. In this
      study we will compare the effect of dexmedetomidine given by different protocols on emergence
      agitation.
    

Intervention name(s): dexmedetomidine; loading dose; sustaining dose
Intervention type(s): Drug; Other; Other
Intervention description(s): an alpha-2 receptor agonist; 0.8ug/kg of dexmedetomidine is given in 10 minutes; 0.4ug/kg/min of dexmedetomidine is given
Other intervention name(s): dex; LD; SD
Intervention MeSH terms: Dexmedetomidine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Treatment
Study on the Association Between SXCI and RM and the Possible Genetic Mechanism
Condition: Infertility Female; Recurrent Miscarriage
MeSH terms: Infertility; Abortion, Spontaneous; Abortion, Habitual; Infertility, Female
Study type: Observational

Summary: 
      To determine whether there is higher incidence of skewed X chromosome inactivation(SXCI) in
      the recurrent miscarriage(RM) population compared with normal population, and verify the
      existing hypothesis of the possible genetic mechanisms underlying the association between
      SXCI and RM.
    

Detailed description: 
      Recurrent spontaneous abortion (RSA), defined as 2 or more consecutive pregnancy losses
      before 20-22 weeks of gestation, is a multifactorial disorder that affects about 5% of all
      couples.In up to 50% of women who have experienced RSA, the cause still remains unexplained,
      with genetic problem proposed as a main cause. X chromosome inactivation (XCI) is a
      physiological phenomenon in female mammals for 'dosage compensation' of X-linked genes with
      males. A normal female is mosaic, with about one-half of her somatic cells expressing the
      paternal derived X and the remainder of her cells using maternal X. In some situations,
      however, the inactivation is not random, resulting in a female having most or even all her
      somatic cells inactivating the same X chromosome from either paternal or maternal resource,
      which is known as skewed X-chromosome inactivation (SXCI).Evidence of an association between
      skewed X chromosome inactivation (SXCI) and idiopathic recurrent spontaneous abortion (RSA)
      is conflicting. This is a single-center observational case-control trial to determine whether
      there is higher incidence of skewed X chromosome inactivation(SXCI) in the recurrent
      miscarriage(RM) population compared with normal population, and verify the existing
      hypothesis of the possible genetic mechanisms underlying the association between SXCI and RM.
    

Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Women visiting our centre for IVF/ICSI during 2015.01.01-2016.01.01 will enter RM group or
        control group according to their pregnant history or infertility factor.

        RM group: Women with a history of recurrent spontaneous abortion (miscarriage occurred
        earlier than 22 weeks of gestation for equal or greater than 2 times).

        Control group:Infertility women because of only male factor. Both groups meet the same
        elgibility criteria
      
Biospecimen description: 
      Blood samples from the females
Efficacy of the Treatment of Plantar Orthoses With Extracorporeal Shock Wave Therapy in Plantar Fasciitis
Condition: Fasciitis, Plantar, Chronic
MeSH terms: Fasciitis; Fasciitis, Plantar
Study type: Interventional

Summary: 
      Plantar fasciitis is inflammation of plantar fascia. It arises from degeneration and chronic
      inflammation. Treatment of plantar fasciitis contains conservative methods like rest, body
      weight control, stretching exercise, non-steroidal anti-inflammatory drugs and arch supports.
      ESWT has commonly been used for the treatment of plantar fasciitis. The shock waves can be
      radial or focused. The aim of this study was to evaluate the effectiveness of the adjuvant
      use of plantar orthoses in the process of plantar fasciitis when extracorporeal shock waves
      are applied. The hypothesis porposed was that the use of extracorporeal shock waves together
      with the use of custom foot orthotics improves the symptoms produced by plantar fasciitis.
      This study is planned as double-blind, randomized controlled trial. Participants are randomly
      allocated to two groups: the ESWT group and the custom foot orthotics and ESWT group. Radial
      ESWT will be applied in this study.

      The people receiving the therapy and the people assessing the outcomes are blinded . Both
      group will recieve ESWT one session per week for three weeks. Each session will last for 2-5
      minutes. The primary outcome measure of this study is change in heel pain of affected side
      assessed using Visual Analog Scale. The secondary outcome measure is Roles y Maudsley scores.
      The primary endpoint of this study is to determine a decrease in pain score according to
      Visual Analog Scale.
    


Intervention name(s): customised foot orthoses; orthotic insole
Intervention type(s): Device; Device
Intervention description(s): The foot orthoses for group A were custom made using phenolic foam molds of the feet. Separated molds were made of both feet for all the participants. . The insole was made based on a positive mold of plaster with 45 Shore cork materials with horizontal thrusts just proximal to the metatarsal heads, with the intention of correcting the pathological subtalar pronation, with a 3mm bilateral raising of the heel and a bilateral latex metatarsal bar.; For group B, a flat insole of polyester resin was made, fitting it to the foot's size.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Fasciitis, Plantar; Foot Orthoses; High-Energy Shock Waves
Canadian Avonex PEN Productivity Study
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis
Study type: Observational

Summary: 
      This study is primarily designed to evaluate the impact of AVONEX PEN autoinjector on work
      capacity of participants with multiple sclerosis (MS) starting on this device. This study
      will also evaluate as secondary endpoints various patient-reported outcomes over the
      short-term (1 month), including adherence, treatment satisfaction and convenience, and the
      long-term (12 and 24 months), including adherence, persistence, quality of life (QOL),
      treatment satisfaction and convenience. It will also assess health resource utilization by MS
      participants starting on AVONEX PEN autoinjector, as well as overall safety/tolerability, and
      will correlate all secondary outcomes with the primary (i.e., work capacity).
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Enrollment will consist of approximately 500 participants who have been prescribed AVONEX
        PEN in accord with its labeling (Product Monograph). This will include participants who are
        naïve to disease modifying therapies (DMTs) as well as those who are being switched from
        another injectable DMT.
The Effect of a Protein Hydrolysate on Muscle Strength Recovery
Condition: Muscle Strength Recovery
Study type: Interventional

Summary: 
      Overtraining is a real problem for (semi-)professional athletes. Overtraining is often caused
      by the bodies' lack of ability to recover between training. In addition, during high
      intensity training reactive oxygen species are formed up to 20 fold compared to resting
      values. This causes increased muscle tissue damage after intense exercise, which slows down
      recovery. Improving recovery may increase an athlete's ability to reach higher training
      volumes resulting in establishing a higher performance plateau.

      It is known that hydrolyzed proteins have a positive effect on muscle protein synthesis due
      to its faster absorption rate. Therefore, it is hypothesized that a known protein hydrolysate
      may have positive effects on strength recovery.
    


Intervention name(s): Protein hydrolysate high dose; Protein hydrolysate low dose; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Physical Activity and Sexuality After Reduction Mammaplasty
Condition: Breast Hypertrophy
MeSH terms: Hypertrophy
Study type: Interventional

Summary: 
      This prospective controlled trial was designed to determine whether breast reduction may
      influence physical activity and sexuality of breast hypertrophy women.
    

Detailed description: 
      Breast hypertrophy is a frequent condition among women; reduction mammaplasty is one of the
      most performed procedures in plastic surgery.Previous studies have demonstrated that breast
      hypertrophy is associated to back pain, and patients often complain about physical
      limitations due to this condition, as well as sexual impairment. Thus, this trial was
      designed to test the hypothesis that reduction mammaplasty may improve physical and sexual
      performance of breast hypertrophy patients,and patients'satisfaction with the results of the
      operation. Three validated tools were used: the International Physical Activity Questionnaire
      (IPAQ), the Female Sexual Quotient and the Breast Evaluation Questionnaire.
    

Intervention name(s): reduction mammaplasty; control
Intervention type(s): Procedure; Other
Intervention description(s): conventional reduction mammaplasty; follow up, questionnaire responses
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Keywords: breast hypertrophy; physical activity; sexuality; patient satisfaction