bioihbjkbjnl/mcl2 huggingface dataset:
The Effect of Transcranial Direct Current Stimulation on Decision Making and Cognitive Flexibility in Gambling Disorder
Condition: Gambling Disorder
MeSH terms: Gambling
Study type: Interventional
Phase: Phase 3

Summary: 
      The investigators conducted a double-blind randomised sham-controlled study. Upon enrollment
      into the study, participants were randomly assigned to one of two conditions: (i) active
      group: anodal stimulation over the right dlPFC (n = 10) or (ii) sham stimulation group (n =
      10). Participants and raters were blinded to the condition.

      Subsequently, the participants were administered the IGT and the Wisconsin Card Sorting Test
      by a trained neuropsychologist in a quiet laboratory. A computerized version of standard IGT
      was used. The order of the tasks performed in a single session was randomised.

      After the psychiatric and neurocognitive assessment, participants received three sessions of
      20-minute active or sham anodal tDCS (once a day, every other day).

      Wisconsin Card Sorting Test and a modified version of Iowa Gambling Test were readministered
      after the last application. The order of the tasks was randomized again. A brief
      questionnaire on study blinding was also administered. Safety was assessed through open-ended
      questions based on the tDCS adverse events questionnaire
    


Intervention name(s): Transcranial direct current stimulation
Intervention type(s): Device
Intervention description(s): Transcranial direct current stimulation (tDCS) is a safe method for non-invasively modulating cortical excitability through the use of weak electrical currents (usually of 1-2 mA) circulating between two scalp electrodes (i.e., an anode and a cathode) placed over the target cortical regions. The effects of tDCS on brain activity are polarity-dependent, such that anodal stimulation generally enhances cortical excitability by depolarizing cell membranes and increasing neuronal firing rates, while cathodal stimulation generally results in the opposite effect. Because of its neural effects, tDCS has been increasingly used to gauge the functional relationship between cognitive/behavioural dimensions and putatively relevant neurocircuitry
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: gambling disorder; cognition
An Online Intervention Promoting HPV Vaccination Among Chinese MSM
Condition: Vaccine Refusal
Study type: Interventional

Summary: 
      Hong Kong Chinese speaking men who have sex with men completed a baseline survey, and then
      received an online intervention promoting uptake of Human Papillomavirus (HPV) vaccination.
      All participants are followed up by telephone 12 months after the completion of baseline
      survey.
    

Detailed description: 
      The primary objective of this study is to investigate prevalence of uptake of Human
      Papillomavirus (HPV) vaccination after exposure to health promotion among men who have sex
      with men in Hong Kong within a 12-month project period.

      Inclusion criteria are Hong Kong Chinese speaking males aged 18-45 years old and
      self-reported having had oral or anal intercourse with at least one man in the last six
      months. Those who have ever received HPV vaccination are excluded.

      Participants are recruited through outreaching in gay venues, online advertisement and
      referral made by peers and non-governmental organization. With verbal informed consent,
      participants completed a baseline survey through telephone. They are then exposed to online
      interventions including: 1) watching an online video, 2) receiving a discount coupon to
      receive HPV vaccination at collaborative private clinics, 3) visiting the project webpage,
      and 4) receiving follow-up reminders 1, 2, 4, 6, and 8 months after the baseline survey.

      All participants are followed up by telephone 12 months after the baseline survey to access
      the primary outcome.
    

Intervention name(s): Intervention
Intervention type(s): Behavioral
Intervention description(s): Viewing a video promoting Human Papillomavirus (HPV) vaccination: participants will watch a 5-minute online video promoting MSM's uptake of HPV vaccination. In the video, a peer MSM discussed about the risk of contracting HPV and having anal cancers among MSM, severe consequences of HPV-related diseases, as well as the benefits of HPV vaccination. He also demonstrated the procedures of taking up HPV vaccination in the collaborative private clinics, which portrayed caring, privacy guaranteed, and non-judgmental environment.
Receiving the discount coupons: each participant will be given a discount coupon. By using the coupon, one can enjoy a 10% discount for taking up three doses of HPV vaccines at a collaborating private clinic.
Visiting the project webpage: Participants can assess the project webpage by scanning the QR code on the discount coupon.
Follow-up reminders: participants received five reminders at Month 1, 2, 4, 6, & 8.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: HPV vaccination
HIV Oral Testing Infographic Experiment
Condition: HIV/AIDS
MeSH terms: Acquired Immunodeficiency Syndrome; HIV Infections
Study type: Interventional

Summary: 
      Premised on the National AIDS Strategy's focus on identifying new HIV infections through
      increased HIV testing, the purpose of this formative pilot study is to develop and test an
      integrated HIV self-testing strategy that utilizes a simplicity-model approach to HIV
      self-testing in emerging adult sexual minority men of color.
    

Detailed description: 
      In the United States, approximately 1.1 million persons are living with HIV. Despite novel
      pharmacological breakthroughs, comprehensive models of health care, and targeted HIV testing
      initiatives, over 160,000 persons are still unaware of their HIV serostatus. Emerging adult,
      sexual minority, men of color are disproportionately affected. Premised on the National AIDS
      Strategy's focus on identifying new HIV infections through increased HIV testing, the purpose
      of this formative pilot study is to develop and test an integrated HIV self-testing strategy
      that utilizes a simplicity-model approach to HIV self-testing in emerging adult sexual
      minority men of color.

      The overall study will focus on: (a) understanding facilitators and barriers to HIV
      self-testing among emerging adult MSM, (b) designing a HIV self-testing infographic that
      utilizes a simplicity model, (c) finalizing the HIV self-testing infographic with input from
      a leadership group of HIV community members, (d) conducting a pilot clinical trial with 300
      emerging adult (ages 18-34), sexual minority, men of color to test if a
      collaboratively-designed HIV self-testing infographic can facilitate accurate and effective
      understanding of how to self-test for HIV when compared to paper-based, HIV self-testing
      information.

      By conducting this study, we will gain beneficial insights necessary for presenting HIV
      self-testing instructions in a meaningful, relevant, and comprehensible way. The results of
      this pilot study have the potential to inform strategies regarding how self-testing
      instructions can be worded or visually presented in order to break both literacy and language
      barriers that affect testing utilization and results accuracy.
    

Intervention name(s): Infographic Intervention; Paper-based HIV self-testing information
Intervention type(s): Behavioral; Behavioral
Intervention description(s): The intervention consists of participants viewing an HIV self-testing infographic.; The control arm will read paper-based HIV self-testing instructions.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Other
Keywords: HIV Prevention; Sexual and Gender Minorities; Consumer Health Informatics
Electroconvulsive Therapy (ECT) for Elderly Patients With Major Depression
Condition: Major Depression
MeSH terms: Depression; Depressive Disorder; Depressive Disorder, Major
Study type: Interventional
Phase: Phase 4

Summary: 
      ECT (electroconvulsive therapy) is mostly given to patients between the age of 60 - 85 years.
      There is limited evidence on the efficacy and cognitive side-effects of right unilateral (RU)
      and bifrontal (BF) electrode positions, the placements that are considered safe for the
      elderly. As far as the investigators know no randomized controlled trials (RCTs) have yet
      been published describing this population treated with BF or RU ECT. Non-demented depressed
      patients will be randomized to either method (n = 2x36). Symptom intensity, global cognitive
      function and biomarkers will be related to 20 healthy comparators. Testing, evaluation of
      depression and blood-tests are done before ECT-treatment, after a series of 6-16 ECT and 3
      months after terminated ECT-treatment.
    

Detailed description: 
      Patients are assessed with Mini Mental Status Examination. Postictal reorientation time is
      measured. There is also a weekly rating of depression depth during the series. After the 6th
      ECT; Mini Mental Status Examination For a subgroup of patients; extensive blood-test samples
      are taken on the day of the 6th ECT.

      Some of the patients receive continuation-ECT once monthly after the series. In these months
      patients receive treatment as usual (naturalistic observation).
    

Intervention name(s): ECT; ECT
Intervention type(s): Device; Device
Intervention description(s): Bifrontal ECT, low dosage; Right unilateral electrode position, high dosage
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
The Effect of Occupational Therapy on Subthreshold Attention Deficit Hyperactivity Disorder
Condition: Attention Deficit and Disruptive Behavior Disorders
MeSH terms: Attention Deficit Disorder with Hyperactivity; Mental Disorders; Problem Behavior; Attention Deficit and Disruptive Behavior Disorders
Study type: Interventional

Summary: 
      The purpose of this study is to investigate the effectiveness of occupational therapy in
      subthreshold attention deficit hyperactivity disorder.
    

Detailed description: 
      Subthreshold attention deficit hyperactivity disorder may occur in a subset of children who
      are possibly more sensitive to their environment. Therefore, it is very important to target
      the elimination of symptoms with appropriate preventive therapies before this disorder
      occurs. One of the promising preventive therapy option may be occupational therapy.

      Attention deficit hyperactivity disorder can have a negative impact on occupational
      performance such as: activities of daily living, education, resting, sleeping, playing and
      social participation. Occupational therapists are able to provide interventions to improve
      engagement in daily activities on social skills, play, executive functioning, impulsivity,
      inattention, and motor coordination.

      Although the guidelines about the treatment of ADHD are primarily medically and
      psychologically based, certain treatment components are useful for occupational therapy
      practice; for example, behavioural management of the child and psychoeducational programmes
      for families.

      However, treatment recommendations for subthreshold ADHD cases or the population at risk are
      limited. This study investigates the effectiveness of occupational therapy in subthreshold
      attention deficit hyperactivity disorder.
    

Intervention name(s): Occupational Therapy
Intervention type(s): Behavioral
Intervention description(s): Occupational therapy to children with subthreshold attention deficit hyperactivity disorder
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Modulation of the Expression of Papillomavirus (HPV) Oncoproteins to Major the Radiosensitivity: Trial Combining an Antiviral Agent VISTIDE and Radiochemotherapy in Cervical Cancers
Condition: Cervical Cancer
MeSH terms: Uterine Cervical Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      The treatment of cervical tumors depends on the stage of the disease. In advanced forms
      (nodal and / or local extension to the vagina and / or parameters) , radiotherapy associated
      with curietherapy , plays a major role. Until recently this association was the standard
      treatment for advanced stage uterine cancer. With this combination, rates of local failures
      (evolutionary prosecution and local recurrences) were 20 to 50% in stages IIb and 50-75 % for
      stage III. More than 50% for patients with a cervical cancer locally advanced (FIGO stages II
      / IV) . The standard treatment, external radiotherapy followed by curietherapy allows expect
      survival rates at 5 years for approximately 30-45 %. For ten years, numerous studies have
      evaluated the addition of concurrent chemotherapy to radiotherapy in cancer of the cervix.
      More than 19 randomized trials have been published. A meta-analysis of these trials was
      undertaken to assess the role of radiochemotherapy in cancers of the cervix. The first
      meta-analysis published by the Cochrane Collaborative Group, taking into account 4580
      patient, shows an improvement in survival, both in terms of progression free survival and
      overall survival for patients treated with radio chemotherapy respectively 16% and 12 % (p <
      0.0001). The rate of metastasis is also decreased (p < 0.0001). Survival rates were
      significantly better when platinum salt was used ( p < 0.0001 ) . However, no clinical
      benefit of chemoradiotherapy has been demonstrated for tumors stages [1, 2] locally advanced,
      possibly due to small number of patients. The investigators have previously shown that
      antiviral agents used in preclinical models, Cidofovir® causes the selective
      radiosensitization of cells infected by the papillomavirus (HPV). This trial proposes to
      study a new concept to increase radiochemotherapy efficiency: the modulation of the
      expression of viral oncoproteins HPV virus by an antiviral agent.
    


Intervention name(s): External radiotherapy + curietherapy; Vistide; Carboplatin
Intervention type(s): Radiation; Drug; Drug
Intervention description(s): External radiotherapy: 45 Gy in 5 weeks Curietherapy: 15Gy; VISTIDE® (mg/kg) Level 1: 1mg/kg Level 2: 2,5 mg/kg Level 3: 5 mg/kg Level 4: 6,5 mg/kg; AUC= 2,5 (Calvert formula)
Intervention MeSH terms: Carboplatin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Vitamin D in Pregnancy and Lactation
Condition: Vitamin D Deficiency
MeSH terms: Vitamin D Deficiency
Study type: Interventional
Phase: Phase 4

Summary: 
      Background: Vitamin D is vital throughout pregnancy and lactation for both maternal and
      infant health. Health Canada recommends women take the AI of 5ug/day of vitamin D during
      pregnancy, however, it is unknown how much vitamin D is necessary to ensure both mother and
      baby reach a vitamin D serum concentration of 25OHD>75nmol/L.
    

Detailed description: 
      Purpose & Hypothesis: This project aims to determine maternal and infant responses vitamin D
      supplementation in pregnancy and lactation. It is hypothesized that the current AI of 5 μg of
      vitamin D will be inadequate for women and their infants in Canada to achieve optimal 25OHD
      concentrations (> 75nmol/L).

      Methods: Healthy pregnant women between 18-42 years of age without history of pregnancy
      complications will be recruited for a double-blind, randomized, controlled trial where they
      will receive one of three different dosages of vitamin D (10, 25 and 50ug/day) as part of a
      standard prenatal vitamin. The study at 18 plus/minus 3 weeks gestation and will carry on
      throughout pregnancy and lactation. Mother and infant vitamin D levels in breast milk and
      blood will be measured at regular intervals. Skin colour will be measured via light
      reflectometry. Bone biomarkers such as plasma osteocalcin and urinary n-telopeptide will be
      assessed. Dietary vitamin D intake and sun exposure will be estimated using a food frequency
      and lifestyle questionnaire. Data will be analyzed using multiple regression analysis
      controlling for baseline values.

      Expected Results & Conclusions: It is expected that greater vitamin D intakes (25, 50ug/day)
      will be necessary to raise maternal and infant serum concentrations to 25OHD>75nmol/L to
      avoid infant supplementation. This data will aid policy makers, mothers and healthcare
      workers in recommended and appropriate vitamin D dosage throughout pregnancy and lactation.
    

Intervention name(s): Vitamin D; Vitamin D3; Vitamin D
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 10 ug/day Vitamin D as part of standard pre-natal vitamin supplement, taken from 18 weeks gestation to 6 months postpartum.; 25 ug/day Vitamin D as part of standard pre-natal vitamin supplement, taken from 18 weeks gestation to 6 months postpartum.; 50 ug/day Vitamin D as part of standard pre-natal vitamin supplement, taken from 18 weeks gestation to 6 months postpartum.
Intervention MeSH terms: Vitamin D; Ergocalciferols; Cholecalciferol; Vitamins
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: Vitamin D; Infant; Lactation; Dose-Response
Video Assisted Ablation of Pilonidal Sinus Versus Conventional Treatment
Condition: Chronic Sacrococcygeal Pilonidal Sinus
MeSH terms: Pilonidal Sinus
Study type: Interventional

Summary: 
      Video assisted ablation of pilonidal sinus (VAAPS) is a new endoscopic minimally invasive
      treatment. In an attempt to validate the effectiveness of the VAAPS, the investigators have
      designed a comparative study between the conventional and the minimally invasive treatment.
      Two surgical procedures were evaluated: VAAPS (Experimental group) and conventional excision
      with a Bascom out-midline closure (Control group).
    


Intervention name(s): Video assisted ablation of pilonidal sinus; Bascom Cleft lift procedure
Intervention type(s): Procedure; Procedure
Intervention description(s): A 5-phases' technique. The 1st phase is to insert the endoscope through the external opening (orifice). In the patients that had more than one opening the lower pit is used for access. The 2nd phase is to identify the sinus cavity and its lateral tracks. The endoscope is advanced along the pathway using slow movements, left/right and up/down. These manoeuvres and the saline solution, used as distension medium, allow the sinus cavity to accommodate the endoscope. Additionally mechanical adhesiolysis with the forceps grasping could be useful. The 3rd phase is to identify the presence of hair and its removal. The 4th phase phase is to obtain complete ablation of sinus cavity. The sinus cavity and its lateral tracks are destroyed with the electrode under continuous direct vision. The 5th phase is to obtain the accurate cleaning of sinus cavity. The saline solution flow allows the elimination of any necrotic material. A Volkmann spoon could be useful to complete the cleaning.
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Relative Bioavailability of BI 44847 in Different Ethnic Groups and Evaluation of Effect of Diet and Acarbose Coadministration on Bioavailability Following Oral Administration of 200 mg BI 44847 in Healthy Male Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The objectives were to investigate the relative bioavailability of BI 44847 in different
      racial groups (white, Asian, and African subjects) and to investigate the effect of different
      types of diet and acarbose coadministration on the bioavailability of BI 44847 in white
      subjects.
    


Intervention name(s): BI 44847; Acarbose; Japanese diet
Intervention type(s): Drug; Drug; Other
Other intervention name(s): Glucobay
Intervention MeSH terms: Acarbose
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Dose Ranging Study Of PF-00868554 In Combination With PEGASYS And COPEGUS In Patients With Chronic Hepatitis C Genotype 1 Infection
Condition: Hepatitis C
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to further assess the potency of PF-00868554, an HCV polymerase
      inhibitor, in subjects chronically infected with HCV by evaluating the antiviral activity of
      PF-00868554 in combination with current standard of care therapy, pegylated
      interferon-alpha2a (PEGASYS) and ribavirin (COPEGUS).
    


Intervention name(s): PF-00868554; PF-00868554; PF-00868554; Placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): 500 mg BID administered as 5x100 mg tablets for 4 weeks in combination with standard of care; standard of care continued for an additional 44 weeks.; 300 mg BID administered as 3x100 mg tablets for 4 weeks in combination with standard of care; standard of care continued for an additional 44 weeks; 200 mg BID administered as 2x100 mg tablets for 4 weeks in combination with standard of care; standard of care continued for an additional 44 weeks; Placebo administered for 4 weeks in combination with standard of care; standard of care continued for an additional 44 weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Intermediate and Long Term Vascular Effects of Cisplatin in Patients With Testicular Cancer
Condition: Testicular Cancer; Cardiovascular Diseases; Cardiovascular Risk Factor
MeSH terms: Testicular Neoplasms; Cardiovascular Diseases
Study type: Observational

Summary: 
      Chemotherapy drugs improve cancer survival but increase the risk of cardiovascular disease
      (CVD). VEGF inhibitors (VEGFI) cause severe hypertension, while cisplatin appears
      pro-thrombotic. Hence while cancer survival may improve, this is at the risk of potentially
      severe CVD and associated morbidity. Mechanisms underlying the cardiovascular toxicities of
      VEGFI and cisplatin are unknown, but effects on vascular function may be important.

      The INTELLECT study will phenotype the endothelial effects of VEGFI and cisplatin using a
      variety of methods.
    

Detailed description: 
      There remains an unmet need to identify a preventive treatment for patients with testicular
      cancer treated with platinum based chemotherapy to diminish the risk of subsequent
      cardiovascular events. A future randomised trial of statin therapy in these patients is under
      consideration and results from this study will inform its design.

      The information gained from this pilot study will guide the development of interventional
      pharmacological studies that are directed towards the most appropriate pathophysiological
      processes, at the most appropriate time and in the most appropriate patient groups treated
      with platinum based chemotherapy for testicular cancer.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        testicular cancer oncology patients