bioihbjkbjnl/mcl2 huggingface dataset:
Patient-controlled Sedation in Port Implantation (PACSPI-1)
Condition: Pain; Patient Satisfaction
Study type: Observational

Summary: 
      The purpose of this prospective, observational study is to assess the feasibility of
      patient-controlled sedation (PCS) for implantation of subcutaneous venous ports (SVP).
    

Detailed description: 
      The main objective of this trial is to study the feasibility of (PCS) with propofol and
      alfentanil during SVP implantation.

      Participants included in the study are able to administer a combination of propofol and
      alfentanil using a patient-controlled sedation pump. This allows the patient to self-control
      their sedation/analgesia during SVP implantation. The pump enables the patient via a
      hand-held button to trigger the release of a single bolus. A bolus of 0.5ml programmed into
      the pump contains a combination of 4.5mg propofol and 25µg alfentanil and is administered
      under a 7 second period resulting in a maximal amount of 8 bolus doses per minute.

      Each SVP implantation procedure is separated into four time points at which sedation scores
      are recorded. Patients are monitored by anaesthesia staff and SVP implantation is performed
      by an anaesthesiologist according to hospital protocol.

      Participants are asked to fill in a written questionnaire to indicate pain score and
      satisfaction with the procedure when ready for discharge.

      Adverse events, time consumption and operators satisfaction with implantation conditions are
      recorded periprocedural.

      The result of this trial will provide guidance for a larger randomized trial (PACSPI-2)
      comparing several clinically relevant aspects of the use of PCS and local anesthesia (LA)
      versus LA alone during SVP implantation.
    

Intervention name(s): Propofol Alfentanil
Intervention type(s): Drug
Intervention description(s): Propofol and Alfentanil are self-administered by the participant.
Other intervention name(s): Propofol/Alfentanil self-administration
Intervention MeSH terms: Alfentanil; Propofol
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Adult patients ≥18 years scheduled for SVP implantation at Ryhov County Hospital.
      
Keywords: patient-controlled sedation; totally implantable venous access devices; subcutaneous implanted venous port; local anesthesia; propofol; alfentanil; indwelling catheter
A Study to Evaluate the Cooling Sensation and Consumer Liking of a Skin Disinfectant Spray
Condition: Skin Care
Study type: Interventional

Summary: 
      The objective of this randomised, examiner and subject blinded study is to evaluate and
      compare cooling performance and overall consumer liking of the prototype formulation with the
      currently marketed wound spray and negative control in subjects with experimental wounds. For
      each subject, three superficial wounds will be induced on two volar forearms, by sequential
      tape strippings until a glistening layer is visualized. After wounding, a randomised test
      product will be sprayed twice on test site, and the subject will be asked to complete a
      questionnaire evaluating product cooling performance and overall liking.
    


Intervention name(s): Prototype disinfectant spray formulation; Reference product; Negative control
Intervention type(s): Other; Other; Other
Intervention description(s): 0.13% w/w BAC and 1% MGA. After wounding, the product will be held approximately 10 cm above the wounding area, and sprayed twice towards the wound; 0.13% w/w BAC. After wounding, the product will be held approximately 10 cm above the wounding area, and sprayed twice towards the wound; 0.9% w/v sodium chloride solution. After wounding, the product will be held approximately 10 cm above the wounding area, and sprayed twice towards the wound
Intervention MeSH terms: Disinfectants
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Outcomes Assessor)
Safety, Immunogenicity, and Dose Ranging Study of Inactivated Zika Virus Vaccine in Healthy Participants
Condition: Virus, Zika; Zika Virus Disease; Flavivirus Infections; Healthy Participants
MeSH terms: Virus Diseases; Zika Virus Infection; Flavivirus Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to describe the safety, tolerability and immunogenicity of two
      doses of purified inactivated Zika virus vaccine (PIZV) given 28 days apart. Three different
      vaccine doses containing different protein concentrations (2, 5 or 10 microgram [mcg]) each,
      will be given as 2 dose schedule to flavivirus naive and primed healthy adults. Participants
      will be followed for 7 days post each dose for tolerability and up to 6 months post dose 2
      for safety. Immunogenicity assessment will be performed at 28 days post each dose and 6
      months post dose 2. In addition, the selected dose group and control group will be followed
      till 24 months post dose 2 for safety and persistence of immunity.
    

Detailed description: 
      The vaccine being tested in this study is called PIZV or TAK-426 adjuvanted with aluminum
      hydroxide. The Zika virus vaccine is being tested to provide safety and immunogenicity data
      to enable the vaccine to be further developed clinically.

      The study will enroll approximately 240 participants. Participants will be randomly assigned
      (by chance, like flipping a coin) to one of the four groups-which will remain undisclosed to
      the study observer:

        -  Placebo

        -  PIZV: 2 microgram (mcg) Low Dose

        -  PIZV: 5 mcg Medium Dose

        -  PIZV: 10 mcg High Dose

      All participants will be administered either placebo or PIZV by intramuscular (IM) injection
      into the middle third of the deltoid muscle, preferably in the non-dominant arm on Days 1
      (Visit 1) and 29 (Visit 4).

      This multi-center trial will be conducted in the United States and Puerto Rico. The overall
      time to participate in this study is up to 25 months. Participants will make multiple visits
      to the clinic on Days 1, 8, 29, 36, 57, 211, 393 and will be contacted by telephone on Day
      133 (Visit 7) and Day 575 (Visit 9) and also visit the clinic on Day 757 (Visit 11) depending
      on the study arm, for a final follow-up assessment.
    

Intervention name(s): Placebo; PIZV
Intervention type(s): Drug; Biological
Intervention description(s): Placebo (normal saline (0.9% NaCl) IM injection.; Purified inactivated Zika virus vaccine with aluminum hydroxide adjuvant IM injection.
Other intervention name(s): TAK-426
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Drug therapy
Impact of Food Carbohydrate and Insulin Dose Computing by on Smart Phone on Glucose Control in Patients With Diabetes
Condition: Type 1 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional

Summary: 
      During this study, we will assess a new smart phone application which aims at helping
      patients with Type 1 diabetes to compute food carbohydrates and meal insulin doses. Patients,
      already trained to carbohydrate counting, will be recruited among those who have been using
      this method daily for at least 6 months. They will complete two one-month study phases, using
      the application in one phase and counting carbohydrate and insulin doses without the
      application in the other phase, with randomized order of each phase. Visits are scheduled at
      the start and at the end of each phase to collect data on glucose control and insulin doses.
      Questionnaires assessing health-related quality of life and ability of self-management of
      diabetes will also be filled by patients before and after each study phase.
    

Detailed description: 
      During this study, we will assess a new smart phone application which aims at helping
      patients with Type 1 diabetes to compute food carbohydrates and meal insulin doses. Patients,
      already trained to carbohydrate counting, will be recruited among those who have been using
      this method daily for at least 6 months.
    

Intervention name(s): Automated carbohydrate and meal insulin dose computing
Intervention type(s): Device
Intervention description(s): Use of smart phone application will compute carbohydrate amount and meal insulin dose according to individual meal insulin/carbohydrate ratio.
Intervention MeSH terms: Insulin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Type 1 diabetes; Smart phone application; carbohydrate counting; meal insulin dose
EUROpE-RSI (EURopean Online Evaluation RSI Study)
Condition: Rapid Sequence Induction
Study type: Observational

Summary: 
      The investigators want to identify and show differences in standards and procedures of
      in-hospital rapid sequence induction by collecting data with an online survey for
      anaesthetist in Europe.
    

Detailed description: 
      The study is designed as a web-based online survey for anaesthetist in Europe. They will be
      invited via mail, as members of the European Society of Anaesthesiology (ESA), the
      participation is voluntary.

      The survey contains 30 items about the standards and procedures of in-hospital rapid sequence
      induction (RSI). There will be a selection of possible answers, only a few items contains
      free-text answers.

      The study collects only personal data to age, country, gender and level of training.

      The collected data should identify differences in the procedures of RSI.
    

Observational model: Other
Time perspective: Other
Sampling method: Non-Probability Sample
Study population: 
        Emergency physicians from europe; e.g. members of the European Society of Anaestesiology
      
Keywords: Rapid Sequence Induction; European; Evaluation; EUROpE RSI; Standards; RSI
SAS-J Compared to OAGB and LSG as a Treatment for Morbid Obesity
Condition: Morbid Obesity
MeSH terms: Obesity; Obesity, Morbid
Study type: Interventional

Summary: 
      150 morbidly obese patients divided into to equal groups, group A underwent single
      anastomosis sleeve jejunal bypass and group B underwent mini gastric bypass, group C
      underwent sleeve gastrectomy. All patients were followed for at least one year. all cases
      were evaluated as regard BMI, complications, nutritional status and obesity-related
      comorbidities.
    

Detailed description: 
      150 morbidly obese patients divided into to equal groups, group A underwent single
      anastomosis sleeve jejunal bypass and group B underwent mini gastric bypass, group C
      underwent sleeve gastrectomy. All patients were followed for at least one year. all cases
      were evaluated as regard BMI, complications, nutritional status and obesity-related
      comorbidities. the minimal follow up period is one year
    

Intervention name(s): SAS-JB; OAGB; LSG
Intervention type(s): Procedure; Procedure; Procedure
Intervention description(s): single anastomosis sleeve jejunal bypass; one anastomosis gastric bypass; laproscopic sleeve gastrectomy
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Study to Test Whether Taking BI 1358894 for 8 Weeks Helps Adults With Post-traumatic Stress Disorder
Condition: Post-Traumatic Stress Disorder
MeSH terms: Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
Study type: Interventional
Phase: Phase 2

Summary: 
      This study is open to people aged 18 to 65 who have post-traumatic stress disorder. The
      purpose of this study is to find out whether a medicine called BI 1358894 improves symptoms
      in people with post-traumatic stress disorder.

      Participants are put into 2 groups randomly, which means by chance. Participants take BI
      1358894 or placebo as tablets every day for 2 months. Placebo tablets look like BI 1358894
      tablets but do not contain any medicine.

      Participants are in the study for about 3 months. During this time, they visit the study site
      about 8 times and get about 4 phone calls from the trial staff. During the study,
      participants answer questions in interviews and complete questionnaires so the doctors can
      check whether their symptoms change.

      The doctors also regularly check participants' health and take note of any unwanted effects.
    


Intervention name(s): BI 1358894; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): BI 1358894; Placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
BI 409306 Cardiac Safety Trial in Healthy Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This trial will be conducted to further evaluate, in a controlled setting, potential cardiac
      effects of an anticipated therapeutic and supra-therapeutic dose of BI 409306 under resting
      and exercise conditions. Since the drug is being developed in part for a disease with an
      expectedly high number of elderly (AD), the characterization of cardiac safety of BI 409306
      is considered to be important for the development of this compound.

      This trial will be conducted to further evaluate, in a controlled setting, potential cardiac
      effects of an anticipated therapeutic and supra-therapeutic dose of BI 409306 under resting
      and exercise conditions.

      Since the drug is being developed in part for a disease with an expectedly high number of
      elderly (AD), the characterization of cardiac safety of BI 409306 is considered to be
      important for the development of this compound.
    


Intervention name(s): BI 409306; BI 409306; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): medium dose, single dose, oral administration; low dose, single dose, oral administration; single dose, oral administration
Intervention MeSH terms: BI 409306
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double
Primary purpose: Treatment
A Study of LY3471851 in Participants With Eczema
Condition: Dermatitis, Atopic
MeSH terms: Dermatitis, Atopic; Dermatitis
Study type: Interventional
Phase: Phase 1

Summary: 
      The main purpose of this study is to learn more about the safety and side effects of
      LY3471851 when given by injection just under the skin to participants with eczema. The study
      will last up to 48 weeks and may include up to 23 visits to the study center.
    


Intervention name(s): LY3471851; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Administered SC; Administered SC
Other intervention name(s): NKTR-358
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Feasibility and Acceptability of Implementing a Clinic-based Physical Activity Coaching Intervention in People With Premanifest and Early Stage HD
Condition: Huntington's Disease
MeSH terms: Huntington Disease
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This study will evaluate the feasibility and acceptability of a clinic-based physical
      activity coaching intervention in people with pre-manifest and early stage Huntington's
      Disease (HD). Fourteen individuals with premanifest and early stage HD will be recruited to
      participate in a 4 month coaching intervention. Feasibility will be assessed by recruitment
      and retention rates, and acceptability will be assessed by participant interviews.
      Participants will also be evaluate at baseline and following the coaching intervention to
      explore preliminary efficacy in terms of physical activity, self efficacy, disease-specific
      motor and cognitive function, walking endurance and strength.
    

Detailed description: 
      The investigators have previously developed and evaluated a physical activity behavioral
      change intervention in people with early-mid stage HD (Engage-HD). In a study conducted in
      the United Kingdom, self-reported physical activity, self-efficacy for exercise, and
      cognition were increased for those in the coaching intervention group compared to a social
      contact control group. This intervention has not yet been applied to individuals with
      pre-manifest (prior to onset of clinical symptoms) and early stage HD, where it may be most
      critical to engage in exercise. To date, no study has prospectively evaluated a physical
      activity intervention to facilitate exercise uptake in these earliest stages. This study will
      explore the feasibility and acceptability of the Engage-HD intervention in 14 individuals
      with pre-manifest and early stage HD. The intervention will entail one face-to-face coaching
      session (approximately 1 hour), and three remote video sessions (via secure Webex connection
      via computer or smart phone, or phone call if internet/smart phone is not available to
      participant) lasting approximately 20 minutes. Participants will also be given FitBit
      wearable activity monitors to allow for self- monitoring of physical activity for use during
      the 4-month intervention. Participants will be evaluated at baseline and again 4 months later
      on a range of exploratory outcomes including physical activity, self efficacy,
      disease-specific motor and cognitive function, walking endurance and strength. Results from
      this study will be used to make relevant adaptations to prepare for a multi-site randomized
      controlled trial.
    

Intervention name(s): Physical Activity Coaching
Intervention type(s): Other
Intervention description(s): Physical activity coaching over 4 months
Intervention model: Single Group Assignment
Intervention model description: Single arm feasibility study with 14 participants
Masking: None (Open Label)
Primary purpose: Other
Treating Brain Swelling in Pediatric Cerebral Malaria
Condition: Malaria, Cerebral
MeSH terms: Malaria; Malaria, Cerebral; Brain Edema
Study type: Interventional
Phase: Phase 3

Summary: 
      This study evaluates the effectiveness of two interventions in Malawian children with
      cerebral malaria at high risk of death. One-third of the participants will receive treatment
      as usual, one-third will receive treatment as usual and be placed on a mechanical ventilator,
      and one-third will receive treatment as usual plus intravenous hypertonic saline.
    

Detailed description: 
      An important mechanism of death in children with cerebral malaria is diffuse cerebral
      swelling, cerebral herniation, compression of the brainstem respiratory center, and
      respiratory arrest. In those who survive their illness without specific interventions,
      reversal of diffuse cerebral swelling is rapid.

      Mechanical ventilation may help to preserve life while diffuse brain swelling diminishes.
      Intravenous hypertonic saline may work as an osmotic diuretic, directly decreasing brain
      swelling.
    

Intervention name(s): Mechanical ventilation; Hypertonic saline
Intervention type(s): Other; Drug
Intervention description(s): Intubation and mechanical ventilation for a maximum of 7 days; Intravenous 3 percent hypertonic saline for a maximum of 7 days
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Participants will be randomly assigned to one of three study arms.
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: coma; pediatrics
Evaluation of Penetration of Ceftobiprole Into Soft Tissue Determined by Microdialysis in Healthy Volunteers
Condition: Staphylococcal Skin Infections; Streptococcal Infections
MeSH terms: Infections; Communicable Diseases; Cellulitis; Skin Diseases, Infectious; Streptococcal Infections; Staphylococcal Skin Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective of this study is to measure the penetration of ceftobiprole into
      subcutaneous (s.c.) adipose tissue and skeletal muscle and to determine the concentration
      over time of ceftobiprole in these tissues and in plasma after administration of a single
      intravenous (i.v.) infusion (directly into the vein) of ceftobiprole 500 mg administered over
      2 hours. The secondary objective was to further assess the safety and tolerability of
      ceftobiprole after a single i.v. infusion.
    

Detailed description: 
      This is a single-center, open-label (all patients involved know the identity of the drug),
      single-arm, nonrandomized study of ceftobiprole in healthy men and women. The study is
      conducted in 2 parts: a pilot study and a main study. Each study (i.e. the pilot study and
      the main study) consists of 3 phases: a pretreatment phase that includes up to a 21-day
      screening period, an open-label treatment phase (1 day in the pilot study and 2 days in the
      main study), and a posttreatment phase that included the end of study evaluations and
      follow-up study visit or telephone contact planned for 1 to 2 weeks after discharge from the
      study unit. Serial blood and dialysis samples will be collected at specified time points from
      predose through 24 hours after the start of the infusion for estimation of ceftobiprole and
      ceftobiprole medocaril concentrations. Additional samples will be collected for measurement
      of protein binding. The study will include the following evaluations of safety and
      tolerability: adverse events, clinical laboratory tests (including hematology, serum
      chemistry, and urinalysis), electrocardiogram (ECG), vital signs, physical examination,
      serology, pregnancy tests, urine drug screen, and alcohol breath test. In the pilot study,
      Ceftobiprole will be locally administered via a microdialysis probe at a concentration of
      approximately 30 µg/mL for 60 minutes. In the main Study, each volunteer will receive
      ceftobiprole locally via the microdialysis probe. After the washout period determined by the
      pilot study, each volunteer will receive a single 2-hour i.v. infusion of ceftobiprole.
    

Intervention name(s): Ceftobiprole
Intervention type(s): Drug
Intervention description(s): single intravenous (i.v.) infusion, 500 mg ceftobiprole administered over 2 hours.
Intervention MeSH terms: Ceftobiprole; Ceftobiprole medocaril
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Staphylococcal Skin Infections; Streptococcal Infections