bioihbjkbjnl/mcl2 huggingface dataset:
Optimising Colorectal Cancer Screening Participation
Condition: Colorectal Neoplasms
MeSH terms: Colorectal Neoplasms
Study type: Interventional

Summary: 
      The aim of this study is to demonstrate the effectiveness of three and four-staged invitation
      procedures compared to two-staged procedures by combining pre-notifications and reminders.
      The RCT will be nested into the Danish colorectal cancer screening programme in the Central
      Denmark Region including men and women aged 50-74 years. Participants will consecutively be
      randomized into four arms in a 1:1 ratio. Intervention arm 1 will receive a pre-notification
      approximately ten days prior to intervention, invitation and one reminder (three-staged
      intervention), Intervention arm 2 will receive invitation, one reminder after 45 days and a
      second reminder three months after invitation (three-staged invitation procedure),
      Intervention arm 3 will receive pre-notification, invitation, reminder after 45 days and
      reminder after three months (four-staged invitation procedure). Finally, the forth arm will
      be a control group receiving usual care which invitation and one reminder 45 days after
      invitation (two-staged invitation procedure). Both pre-notifications and reminders are sent
      using digital mail.

      The main out-come will be participation within 6 months after invitation.
    


Intervention name(s): Invitation procedure
Intervention type(s): Procedure
Intervention description(s): Optimised invitation procedures in an organised colorectal cancer screening programme
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: mass screening
Study of Brain Response to Emotional Pictures Using a fMRI While on Duloxetine
Condition: Major Depression
MeSH terms: Depression; Depressive Disorder; Depressive Disorder, Major
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to find out what parts of the brain have increased or decreased
      activity when people are depressed and how antidepressant medicine changes this activity in
      depressed patients. The genetic samples collected are to look at variation in a gene
      (serotonin transporter gene), which affects the functioning of the chemical serotonin in the
      brain
    

Detailed description: 
      This study will measure the activity in different parts of the brain, while the patients are
      seeing some pictures, using Magnetic Resonance Imaging (MRI) scan. For this study three MRI
      scans will be conducted. One before the patient begins on any medication, one during the
      study after 3 weeks of treatment and one after six more weeks of treatment with a standard
      antidepressant called duloxetine.
    

Intervention name(s): Duloxetine
Intervention type(s): Drug
Intervention description(s): 60 mg capsules
Other intervention name(s): Cymbalta
Intervention MeSH terms: Duloxetine Hydrochloride
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Depression; Duloxetine; fMRI; pictures
A Comparison of Morphine and Morphine Plus Dexmedetomidine in Chronic Cancer Pain
Condition: Chronic Pain
MeSH terms: Chronic Pain; Cancer Pain
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to determine whether dexmedetomidine added to morphine is
      effective in the treatment of chronic cancer pain.
    

Detailed description: 
      We conduct the study in Cukurova University Faculty of Medicine Research Hospital after
      obtaining ethics committee approval and patient's informed consent. Patients with cancer pain
      are allocated into two group to receive Patient Controlled Analgesia with morphine or
      morphine plus dexmedetomidine.
    

Intervention name(s): Morphine; Morphine plus dexmedetomidine
Intervention type(s): Drug; Drug
Intervention description(s): Morphine, 0.02 mg/kg PCA bolus dose with 10 minutes lock-out interval; Morphine 0.02 mg/kg plus dexmedetomidine 0.1 microgram/kg PCA bolus dose with 10 minutes lock-out interval
Other intervention name(s): morphine sulphate; Morphine sulphate plus dexmedetomidine
Intervention MeSH terms: Dexmedetomidine; Morphine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Chronic pain; Morphine; Dexmedetomidine
Treatment of Tracheostomy Granulomas
Condition: Granuloma; Tracheostomy
MeSH terms: Granuloma
Study type: Interventional
Phase: Phase 4

Summary: 
      This study plans to learn more about the different ways used to treat tracheostomy
      granulomas. Investigators want to see which standard of care method (steroid application,
      silver nitrate, or betadine) is more successful in treating tracheostomy granulomas.
    

Detailed description: 
      Upon joining the study patients will be assigned to one of the three treatment groups
      (steroid application, silver nitrate, and betadine). These three treatments are standard of
      care and patients would have been treated with one of them anyway. Patients will be followed
      for an observation period of six weeks with follow-up appointments, per standard of care,
      every two weeks (+/- 3 days) in order for a physician to evaluate if the treatment method is
      working. If during a follow-up visit, the physician determines the treatment method is not
      working, the follow-up period will end and participation in the study will be complete. In
      addition, if a patient is given a different form of treatment during the observation period,
      such as in the emergency department or through their primary care physician, the follow-up
      period will end and participation in the study will be complete.
    

Intervention name(s): Betadine; Silver Nitrate; Hydrocortisone Butyrate Cream, 1.0%
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Apply locally as needed.; Arzol Silver Nitrate Applicators may be applied directly to mucous membranes and other moist surfaces. In the case of dry skin, the applicator tip should be dipped in water immediately before use. Apply carefully to the area to be treated.; Hydrocortisone butyrate cream, 1.0% should be applied to the affected area as a thin film two or three times daily depending on the severity of the condition.
Intervention MeSH terms: Povidone-Iodine; Silver Nitrate; Hydrocortisone; Hydrocortisone-17-butyrate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Telephone Cognitive Behavioral Therapy for Veterans Undergoing Surgery
Condition: Persistent Post-surgical Pain; Veterans
MeSH terms: Pain, Postoperative
Study type: Interventional

Summary: 
      The study team propose to investigate the feasibility and pilot a Telephone Cognitive
      Behavioral Therapy intervention for those identified to be at risk for chronic pain following
      surgery.
    


Intervention name(s): Telephone-based Cognitive Behavioral Therapy (CBT)
Intervention type(s): Behavioral
Intervention description(s): Four session telephone CBT protocol.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Phase IIb One Year Efficacy and Safety Study of S-2367 in Obese Subjects With Reduced Calorie Diet
Condition: Obesity
MeSH terms: Obesity
Study type: Interventional
Phase: Phase 2

Summary: 
      1. To evaluate the effect of S-2367 on body weight when administered following a 6-week
           placebo lead-in period and then a 54-week 800 kilocalorie deficit reduced calorie diet
           compared to placebo in healthy obese male and female subjects

        2. To evaluate the safety and tolerability of S-2367 during 54 weeks of drug exposure

        3. To evaluate the steady-state/trough pharmacokinetics of S-2367
    


Intervention name(s): S-2367 Placebo; S-2367 800 mg; S-2367 1600 mg; Reduced Calorie Diet
Intervention type(s): Drug; Drug; Drug; Other
Intervention description(s): four placebo tablets (total dose = 0 mg/day S-2367) administered orally once-a-day with morning meal while on a reduced calorie diet for a total of 54 weeks,; two 400 mg S-2367 tablets (total dose = 800 mg/day S-2367) administered orally once-a-day with morning meal while on a reduced calorie diet for a total of 54 weeks; four 400 mg S-2367 tablets (total dose = 1600 mg/day S-2367) administered orally once-a-day with morning meal while on a reduced calorie diet for total of 54 weeks,; A diet with restricted calorie content
Other intervention name(s): Velneperit; Velneperit
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Obesity
Internet Self-Management Program With Telephone Support for Adolescents With Arthritis
Condition: Juvenile Idiopathic Arthritis
MeSH terms: Arthritis; Arthritis, Juvenile
Study type: Interventional

Summary: 
      This study will evaluate the feasibility of "Teens Taking Charge: Managing Arthritis On-line"
      intervention that will help adolescents with arthritis to better manage their disease and
      improve their health-related quality of life (HRQL).
    

Detailed description: 
      This feasibility study will (1) assess adolescents' willingness to be randomized; (2) pilot
      the intervention, attention control strategies (e.g., adolescents' 'own best efforts' at
      managing arthritis), and outcome measures; (3) determine adolescents' perceptions regarding
      acceptability of the web-based intervention; and (4) obtain estimates of treatment effects in
      primary (HRQL) and secondary (knowledge, coping, self-efficacy, stress, treatment adherence,
      pain) outcome measures to inform the calculation of appropriate sample size for the future
      RCT.

      We hypothesize that adolescents with JIA in the web-based intervention will demonstrate: (a)
      improved HRQL; (b) increased disease-specific knowledge; (c) improved coping, self-efficacy,
      and adherence to prescribed management; and (d) decreased pain and stress compared to
      adolescents in the attention control group
    

Intervention name(s): Teens Taking Charge; Self-Management
Intervention type(s): Behavioral; Behavioral
Intervention description(s): The intervention is a 12-week multi-component treatment protocol that consists of self-management strategies (e.g., how to deal with stress and treatment related symptoms like pain), information (e.g., common problems associated with treatment and disease) and social support (e.g., monitored discussion boards and narratives in the form of written stories and video clips). It will be delivered on a restricted web-site and through regular contact with a trained coach by means of email and/or telephone using standardized scripts.; Adolescents' "own best efforts" at managing their JIA
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Teens Taking Charge; Managing Arthritis Online; juvenile idiopathic arthritis; internet; self-management
Powered Exoskeleton for the Treatment of Elbow Spasticity
Condition: Muscle Spasticity; Stroke
MeSH terms: Muscle Spasticity
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a phase-II clinical study to assess whether intense passive mobilization of the elbow
      during the early stage is effective in preventing spasticity from occurring at a later stage.
      A group of subacute stroke patients was treated with the device named NEUROExos Elbow Module
      (NEEM) on a daily basis, in addition to traditional physical therapy. The outcome was
      assessed in terms of (i) system safety, (ii) system usability and (iii) treatment efficacy.

      Investigators expected that intense therapy performed in the sub-acute phase following the
      stroke would be effective in preventing elbow spasticity from occurring at a later stage
      (i.e. 3-4 months after the stroke), the latter being quantified by means of the Modified
      Ashworth Scale (MAS). Similarly to other phase-II studies in the field of post-stroke
      rehabilitation, the present study will include only one group of patients. As a secondary
      objective, similarly to other studies with robot-assisted therapy, investigators wiil test
      the ability of this system to be used for assessing rehabilitation outcome. Investigators
      will introduce novel evaluation metrics based on the kinematics and kinetics variables
      recorded by the NEEM and compared them with MAS values.
    


Intervention name(s): Robotic treatment
Intervention type(s): Device
Intervention description(s): Passive/active elbow mobilizzation provided by NEUROExos Elbow Module Robotic device
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Robotics; Upper Extremity
A Study to Evaluate the Pharmacokinetics and Safety of Fezolinetant in Healthy Chinese Female Subjects
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the pharmacokinetics and safety of fezolinetant
      after single-dose and multiple dose administration in healthy Chinese female participants.
    

Detailed description: 
      Participants will undergo screening evaluations to determine their eligibility within 21 days
      prior to the study enrollment.

      Participants will be admitted to the clinical unit a day before administration (day -1) and
      will be confined in the clinical unit until 48 hours after last administration (day 18).
    

Intervention name(s): fezolinetant
Intervention type(s): Drug
Intervention description(s): oral
Other intervention name(s): ESN364
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Fezolinetant; Pharmacokinetics; ESN364; Healthy Volunteer
Influence of Arrangement of Small Intestine Order on the Recovery of Bowel Function After Laparoscopic Colorectal Surgery
Condition: Postoperative Complications
MeSH terms: Postoperative Complications
Study type: Interventional

Summary: 
      The method of arranging and restoring the position of the small intestine under laparoscopy
      is used to determine whether it can promote the recovery of intestinal function after
      colorectal surgery.
    


Intervention name(s): Arrangement of small intestine order before close the abdomen
Intervention type(s): Procedure
Intervention description(s): After the completion of laparoscopic-assisted colorectal cancer surgery, the chief surgeon performed laparoscopic small bowel arrangement before closing the abdomen, straightening the small bowel from the colon-small bowel anastomosis or the ileocecal valve to the ligament of Trevor, and restoring the original position of the small bowel. Afterward, close the abdomen.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Using Social Media to Enhance the Impact of the Teen Outreach Program
Condition: Pregnancy Prevention
Study type: Interventional

Summary: 
      The investigators are exploring the use of short message service (text) messaging by cell
      phones to enhance the effects of the Teen Outreach Program, an effective teen pregnancy
      prevention program.
    


Intervention name(s): Teen Outreach Program with Media Enhancement (TOP4ME)
Intervention type(s): Behavioral
Intervention description(s): Persons participating in TOP will receive text messages weekly in addition to TOP
Other intervention name(s): Youth All Engaged! (YAE!)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Clinical Trial Comparing Dapaconazole Versus Miconazole in Patients With Tinea Cruris
Condition: Tinea Cruris
MeSH terms: Tinea; Tinea cruris
Study type: Interventional
Phase: Phase 2

Summary: 
      This trial aims to evaluate the efficacy of dapaconazole tosylate 2% cream in the treatment
      of Tinea cruris compared to the active control miconazole nitrate 2% cream in patients with a
      single lesion.
    

Detailed description: 
      This is a phase 2, non-inferiority, monocentric, double-blind, randomized (allocation of
      treatment), balanced, controlled (active comparator) trial, with two parallel groups.

      Randomization depended on inclusion/exclusion criteria, taking into account the confirmation
      of diagnosis by the direct mycological test and culture performed during the screening phase.

      Participants showed up to the clinic, for treatment, during 14 consecutive days, when one of
      the investigational products (according to the randomization) was applied by a blind member
      of the study staff. A non-blind member of the study staff weighed the corresponding
      investigational product and passed on to the blind member only a spatula with the weighed
      product, in order to maintain the blinded aspect of the trial.

      For exploratory purposes, clinical and mycological evaluations was also performed after 7 and
      after 14 days of treatment.

      Safety analysis was performed considering all the randomized patients to which at least one
      dose of the investigational products has been applied, regardless of the result of the fungal
      culture.

      Conclusion of non-inferiority was based on the per protocol set. It was deemed as per
      protocol those participants who did not miss more than 20% of the applications and, also, no
      more than four consecutive application days.
    

Intervention name(s): Dapaconazole; Miconazole Nitrate
Intervention type(s): Drug; Drug
Intervention description(s): Application of 1 gram on the lesion.; Application of 1 gram on the lesion.
Other intervention name(s): Zilt; Vodol
Intervention MeSH terms: Miconazole; Clotrimazole
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Tinea cruris; dapaconazole; topical antifungal; dermatophytoses
Effectiveness of the RemedRugby Program
Condition: Schizophrenia; Social Cognition; Self Esteem; Empowerment; Recovery
MeSH terms: Schizophrenia
Study type: Interventional

Summary: 
      REMEDRUGBY's objective is to strengthen the capacity of users to interact with others in an
      assertive way and to fight against stigma. It proposes to specifically target the processes
      of "social cognition".

      "Social cognition" brings together the mental mechanisms that allow everyone to decipher the
      social situations, emotions and intentions of others and interact with others in the
      different contexts of everyday life.

      People with a psychic handicap frequently have difficulties in this area, which has often
      important consequences for their social and professional integration.

      The REMEDRUGBY program proposes to work specifically on these processes in the context of
      sport (+ role Play and blog) to strengthen the ability to interact with others and to deal
      with the stigma that can be encountered on a daily basis.
    


Intervention name(s): REMEDRUGBY PROGRAM; TOUCH RUGBY PROGRAM; TAU
Intervention type(s): Other; Other; Other
Intervention description(s): 1st Session presentation of the programme, its objectives and a common reflection on the concepts of stigmatization/destigmatization.
2nd to 4th session devoted to a group reflection on social conventions and their meaning followed by a practice by means of role-playing.
5th to 7th session devoted to writing comments about tournaments on the blog by working on the intentions of others and the emotional impact of comments on their recipients.
8th, 9th 11th sessions devoted to media relations with group reflection on the image of themselves and their pathology that participants wish to refer to the media, followed by a practice in role-playing games Interviewer-interviewed
10th session devoted to planning and organizing the day of matches with writing a program of the day and spreading on the blog
12th General Debriefing session Including : - 3 tournaments
8 hours of Touch Rugby; Practical training Program at Touchrugby at the rate of 12 weekly sessions of 2 hours and 3 inter-institutional tournaments per day; Treatment as usual
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: RemedRugby program Vs TAU + TouchRugby
Masking: None (Open Label)
Primary purpose: Treatment
Effect of Surfactants on the Skin Microbiome
Condition: Healthy Skin
Study type: Interventional

Summary: 
      Up to 10 volunteers will be recruited to evaluate the microbial environment on their
      forearms. Following informed consent, bacterial swabs will be obtained at baseline from the
      forearms of all subjects. Their forearms will then be washed with one of the study cleansers.
      Subjects will then have their forearms swabbed for bacteria at the following time points: 10
      minutes, 6 hours, and 24 hours after the wash. DNA will be extracted from all swabs and
      bacterial diversity evaluated by 16S pyrosequencing.
    

Detailed description: 
      The timeline for the patients will be as follows:

      On Day 0, after being given a witnessed, written, informed consent, a medical history and a
      limited physical exam will be performed. If using certain topical products and medications
      that are not allowed during this study, patients may be asked to withhold them for the
      remainder of the study. The study doctor or study coordinator will explain which medications
      and activities are not allowed during this study. Baseline bacterial swabs from the bilateral
      volar forearms will be collected followed by application and rinsing of a hand wash with an
      antimicrobial compound (benzalkonium chloride or triclocarban) on the right forearm, and a
      cleanser without an antimicrobial compound (control) on the left forearm. 200 microliters of
      water/hand wash will be applied to the volar forearms and lather generated for 15 seconds
      using a gloved hand. The lather will be allowed to stay in contact with the skin for an
      additional 30 seconds. The total contact time will be 60 sec. The forearm will be rinsed with
      running tap water for 15 seconds, air-dried for 5 minutes and the skin surface will again be
      swabbed for bacteria 10 minutes after the wash. The same procedure will be repeated on the
      2nd volar forearm with the opposing wash. Subjects will then have repeat skin swabs at 6
      hours +/- 1 hour and at 24 hours +/- 6 hours after washing. Subjects will be instructed to
      avoid rigorous exercise/swimming, significant sun exposure (i.e. sunbathing), cleaning the
      forearms with other antibacterial products, and showering during these 24 hours.
    

Intervention name(s): Control Hand Soap; Benzalkonium Chloride Soap; Triclocarban Soap
Intervention type(s): Other; Other; Other
Intervention description(s): Commercially available soap will be used to wash the subject's forearms; Commercially available soap containing benzalkonium chloride will be used to wash the subject's forearms; Commercially available soap containing triclocarban will be used to wash the subject's forearms
Intervention MeSH terms: Benzalkonium Compounds; Triclocarban
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: study; subjects