bioihbjkbjnl/mcl2 huggingface dataset:
Rehabilitation for Improved Cognition
Condition: Exhaustion; Syndrome; Burnout Syndrome
MeSH terms: Syndrome; Burnout, Psychological
Study type: Interventional

Summary: 
      Many patients with exhaustion disorders continue to have significant difficulties with
      attention and memory function which reduce their work ability. This randomized study
      investigates whether the addition of a 12-week period of specific cognitive training or
      physical fitness training could further enhance cognitive function in patients with
      exhaustion disorder participating in a multimodal rehabilitation program.
    

Detailed description: 
      This study was performed at The Stress Rehabilitation Clinic at the University hospital of
      Umeå. In total 161 patients with diagnosed exhaustion disorder were recruited consecutively
      to the study from March 2010 until June 2013. Participants were all in age span 18-60 years
      old, had an ongoing employment and were assessed as suitable for a 24-week multimodal
      rehabilitation, which consisted of cognitive behavioural therapy in group (maximum eight
      persons), prescription of physical activity/exercise (FaR©) and vocational measures with
      rehabilitation meetings. A randomization by group was performed after 12 weeks of multimodal
      rehabilitation to one of three conditions; A/ continued multimodal rehabilitation, B/
      addition of a computer-based cognitive training, and C/ addition of physical fitness
      training. The added training was performed during the last 12 weeks of rehabilitation (week
      12 to 24) and with three weekly training occasions. Primary endpoint was change in cognitive
      functioning, estimated as a global brain score. Secondary endpoints were changes in different
      specific neuropsychological tasks, estimated psychological wellbeing, physical capacity, work
      ability, health-related quality of life and cost-effectiveness. A long-term follow-up was
      performed one year after termination of the interventions (at week 76).
    

Intervention name(s): Computer-based cognitive training; Physical fitness training
Intervention type(s): Behavioral; Behavioral
Intervention description(s): A total of 36 training sessions, approximately 20 minutes long each. Five different tasks were used in training all tapping different aspects of cognitive control such as updating, shifting, visuo-spatial working memory and episodic memory binding.; A total of 36 training sessions, approximately 40 minutes long each, with physical fitness training performed as group indoor cycling. The participants were instructed to attain a load of approximately 65-80% of their maximum heart rate.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
The Relationship Between Traumatic Brain Injury and Dopamine (a Chemical in the Brain)
Condition: Traumatic Brain Injury
MeSH terms: Brain Injuries; Brain Injuries, Traumatic; Wounds and Injuries
Study type: Interventional
Phase: Phase 4

Summary: 
      Traumatic brain injury (TBI) is the most common cause of death and disability in young
      adults. Patients can experience significant problems with concentration, attention, and
      memory (so called 'cognitive impairments') following TBI. These cognitive impairments can
      drastically impact on a patient's well-being, and can lead to significant economic and social
      consequences. Roughly a quarter of TBI patients improve but an equal number deteriorate over
      time. The investigators know little about why patients vary so much in how they recover.
      Crucially, the investigators have no treatments to improve brain functioning or recovery
      after TBI.

      Trials investigating ways of protecting the brain just after injury have been disappointing.
      An alternative strategy, however, is to improve the function of brain regions that remain
      intact, but that function inefficiently after TBI. The investigators know that dopamine (a
      chemical in the brain) is known to influence many brain functions and the investigators know
      that pathways in the brain that use dopamine are affected by TBI.

      In humans, drugs that increase dopamine in the brain, such as methylphenidate, are sometimes
      used to enhance cognitive function after TBI, but the response to treatment can be highly
      variable between patients. Therefore, what is needed in the clinic is a way to target the use
      of these drugs to patients who are likely to respond.

      In a single centre study, the investigators will use SPECT (Single Photon Emission
      Tomography) imaging to measure dopamine levels in the brain. MRI (Magnetic Resonance Imaging)
      scans will assess brain structure and function. The investigators will test whether treatment
      with methylphenidate improves cognitive functions in TBI patients who have ongoing cognitive
      problems, whether the mechanism involves a normalisation of brain functioning and whether
      brain dopamine levels can predict the magnitude of any improvement in symptoms.
    


Intervention name(s): Methylphenidate; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Cross-over design comparing methylphenidate 0.3 mg/kg (to nearest 5mg) twice daily to placebo; Twice daily placebo tablet for two weeks
Intervention MeSH terms: Methylphenidate
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
EPI, a Missed Opportunity for Postpartum Family Planning Utilization
Condition: Contraception
Study type: Observational

Summary: 
      The global unmet need for postpartum family planning remains high, while immunization
      services are among the most widely utilized health services. Most women in the extended
      postpartum period want to delay or avoid future pregnancies but many are not using a modern
      contraceptive method. Establishing systematic screening, counseling, and referral systems
      from different contact points particularly from infant immunization units may improve family
      planning access and uptake in the extended postpartum period. Hence, this study is aimed to
      assess the effect of counseling for family planning at immunization units on postpartum
      contraceptive uptake during the extended postpartum period.
    

Detailed description: 
      Background: The global unmet need for postpartum family planning remains high, while
      immunization services are among the most widely utilized health services. Most women in the
      extended postpartum period want to delay or avoid future pregnancies but many are not using a
      modern contraceptive method. Establishing systematic screening, counseling, and referral
      systems from different contact points particularly from Expanded Program for Immunization
      (EPI) units may improve family planning access and uptake in the extended perinatal period.

      Therefore, this study is proposed to assess the effect of counseling for family planning at
      immunization units on postpartum contraceptive uptake during the extended postpartum period.

      To do this, a before-and-after type of quasi-experimental study will be conducted in
      purposively selected health centers in Sidama, South Ethiopia. All mothers coming to the
      selected health centers for infant immunization services will be screened for, counseled, and
      referred for family planning. A structured interviewer-administered questionnaire will be
      used to collect quantitative data from a total of 1474 randomly selected women coming to
      purposively selected health centers before and after the intervention. Bivariate and
      multivariable logistic regression analysis adjusting for possible confounding variables will
      be computed.
    

Intervention name(s): counseling for family planning
Intervention type(s): Behavioral
Intervention description(s): all mothers presented to infant immunization units of the selected health centers will be counseled for family planning service and referred to the family planning unit if they decided to use.
Observational model: Other
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        All women in the extended postpartum period visiting the selected health centers for infant
        immunization service are the study populations.
Impact of PIVC Length and Gauge on Catheter Indwell Time
Condition: Indication for Peripheral Intravenous Catheterisation
Study type: Interventional

Summary: 
      This is a single-centre, open-label, multi-visit study design, in 40 healthy participants,
      randomized by gauge of peripheral intravenous catheter (PIVC) device into the lower arm
      cephalic vein of both arms.

      The purpose of this study is to assess impact of catheter length and gauge on PIVC indwell
      time over a 72 hour period. This study will also evaluate the incidence of haemolysis using
      blood draws from the PIVC.
    

Detailed description: 
      The study aims to provide preliminary information on the performance of the peripheral
      intravenous catheter (PIVC) device,

        -  assess how blood collection through different catheters over time effects device
           performance, and

        -  assess the quality of the blood that is collected through those catheters. Four
           variations of the BD Nexiva PIVC will be used in this study. Participants will be
           randomised by gauge of peripheral intravenous catheter (PIVC) device into the lower arm
           cephalic vein of both arms. PIVC indwell time will be monitored up to 72 hrs (removal at
           72 hrs or upon inability to flush/aspirate). Blood will be collected Day 1 throughout
           the remainder of indwell time.

      Each participant will complete 6 visits: a Screening Visit (V1), PIVC in situ (V2-V5) and
      follow-up (V6).

      The in-situ catheter positions will be compared to the expected tip position based on the
      catheter lengths. Blood collected will be analysed for haemolysis.

      As both device length and gauge are expected to influence haemolysis the study design enables
      evaluation of both design features.
    

Intervention name(s): Peripheral Intravenous Catheter
Intervention type(s): Device
Intervention description(s): Randomised controlled
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomised, controlled
Masking: None (Open Label)
Primary purpose: Basic Science
Impact of Structured Physical Activity Education Delivery in Patients With Type 2 Diabetes Mellitus
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      The objective of this study is to assess whether a structured exercise program compared to
      routine recommendation for exercise has any positive impact on disease outcome in patients
      with type 2 diabetes.

      This study aims to assess whether a structured exercise program has an impact on the
      following determinants of the disease in type 2 diabetes: HbA1C, blood pressure, lipids, body
      mass index and waist circumference. It also aims to assess the compliance and retention of
      patients with type 2 diabetes in a structured exercise program.
    


Intervention name(s): Physical activity and exercise education and behaviour counseling from a Registered Kinesiologist and a YMCA Wellness Coach; Unstructured Physical Activity and Exercise Education
Intervention type(s): Behavioral; Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Hydrocodone For Pain Control in First Trimester Surgical Abortion
Condition: Pain
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to determine whether preoperatively administered
      hydrocodone/acetaminophen (HC/APAP) reduces pain during a first trimester surgical abortion.
    

Detailed description: 
      The investigators plan to conduct a double-blinded randomized placebo-controlled trial of 120
      women undergoing elective first trimester surgical abortion. These women will be premedicated
      with either two tabs of 5/350 hydrocodone/acetaminophen or 2 tabs of a placebo. All subjects
      will receive ibuprofen and lorazepam preoperatively and a PCB. This study will examine the
      incremental benefit of HC/APAP over this standard medication regimen. Randomization will be
      stratified into two groups. Subjects less than 8 weeks gestation will comprise the early
      gestational age group. Subjects between 8 weeks 0 days and 10 weeks 6 days will comprise the
      late gestational age group. The investigators will be assessing patient perception of pain,
      nausea, satisfaction, and anxiety at multiple points during the clinic visit using 100-mm
      visual analogue scales (VAS).
    

Intervention name(s): Hydrocodone/acetaminophen; Placebo; Ibuprofen; Lorazepam; Lidocaine
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): Administration of 2 tablets 5/325mg hydrocodone/acetaminophen 45-90 minutes prior to procedure.; Administration of 2 tablets methylcellulose (placebo) 45-90 minutes prior to procedure.; 800 mg oral ibuprofen; 2 mg oral lorazepam; 20 ml 1% buffered lidocaine, injected
Other intervention name(s): Vicodin
Intervention MeSH terms: Acetaminophen; Ibuprofen; Acetaminophen, hydrocodone drug combination; Lidocaine; Hydrocodone; Lorazepam
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Pain during first trimester surgical abortion
Behavioral Activation for Treatment of Depression in Adolescents With Autism
Condition: Depression; Autism
MeSH terms: Depression; Depressive Disorder; Autistic Disorder
Study type: Interventional

Summary: 
      In this study, the investigators will examine the feasibility, acceptability, and preliminary
      efficacy of a novel, behavior-based approach for treatment of depression symptoms in
      adolescents with autism spectrum disorder or ASD (i.e., Behavioral Activation for Adolescents
      with ASD, BA-A).
    

Detailed description: 
      In this study, the investigators will examine the feasibility, acceptability, and preliminary
      efficacy of a novel, behavior-based approach for treatment of depression symptoms in
      adolescents with ASD (i.e., Behavioral Activation for Adolescents with ASD, BA-A). BA-A is a
      12-session manualized treatment that utilizes established behavioral activation strategies
      and incorporates common mental health treatment adaptations for young people with ASD. For
      this project, the investigators will pilot BA-A with 23 adolescents (12-17 years of age) with
      ASD and clinically significant depression symptoms. To investigate BA-A feasibility, the
      investigators will examine treatment session attendance and therapist treatment fidelity. To
      investigate BA-A acceptability, the investigators will utilize a mixed methods approach,
      inclusive of surveys and qualitative interviews, to inform BA-A protocol refinement. To
      investigate BA-A preliminary efficacy, the investigators will examine depression symptoms, as
      well as secondary outcome measures, at pre-treatment, post-treatment, and one-month
      follow-up.
    

Intervention name(s): BA-A
Intervention type(s): Behavioral
Intervention description(s): Session 1 focuses on the treatment rationale, structure, and expectations, and includes psychoeducation on depression. Session 2 focuses on working with parent(s) to help them support their teen through treatment. Session 3 focuses on the (situation)/behavior/feeling cycle and how teens individuals can get trapped in a cycle of depression and inactivity. Session 4 focuses on the assessment of values and choosing preferred activities to target. Session 5 focuses on teaching skills for in-person and electronic communication. Session 6 focuses on identifying barriers to treatment success. Session 7 focuses on teaching teens to handle disagreements. Session 8 focuses on the utilization of adaptive coping skills. Sessions 9-11 are meant to be used flexibly and should include review of any challenging concepts. Session 12 is the termination session and focuses on maintaining treatment gains. Between every session, teens will track their activity for homework.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Efficacy and Safety of Remdesivir and Tociluzumab for the Management of Severe COVID-19: A Randomized Controlled Trial
Condition: Covid19; Covid-19 ARDS
MeSH terms: COVID-19
Study type: Interventional
Phase: Phase 3

Summary: 
      This randomized clinical trial was designed and intended to evaluate the efficacy of
      Remdesivir and Tocilizumab as a treatment for severe Acute Respiratory Distress Syndrome
      (ARDS) caused by Coronavirus disease 2019 (COVID-19). Our aim is to find the best option for
      the treatment and management of ARDS in COVID-19 patients.
    


Intervention name(s): Remdesivir; Tocilizumab
Intervention type(s): Drug; Drug
Intervention description(s): Remdesivir 100 IV Infusion as a lyophilized powder; Actemra IV Infusion
Other intervention name(s): Actemra IV Infusion
Intervention MeSH terms: Remdesivir
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: COVID 19; Remdesivir; Ticilizumab; COVID-19 ARDS
Seal-G / Seal-G MIST Study
Condition: Colon Cancer; Gastrointestinal Cancer
MeSH terms: Gastrointestinal Neoplasms
Study type: Interventional

Summary: 
      A prospective, multi-center, open label, study to evaluate safety and performance of Seal-G
      and Seal-G MIST in reinforcing colonic anastomosis, in subjects undergoing Colon Resection
      surgery
    

Detailed description: 
      Seal-G and Seal-G MIST Surgical Sealants are intended for the reinforcement and protection of
      gastrointestinal anastomosis. The Seal-G and Seal-G MIST devices share the same Alginate
      based sealant technology and intended purpose. The devices only differ in their method of
      application, The Seal-G device is designed for spread application by extra-corporal approach,
      and the Seal-G MIST device is designed for spray application by intra-corporal approach.

      The proposed Clinical Investigation aims to collect clinical evidence on the devices' usage,
      including safety, performance and usability.
    

Intervention name(s): Seal-G Surgical Sealant; Seal-G MIST System
Intervention type(s): Device; Device
Intervention description(s): Seal-G is a surgical sealant intended for use as an adjunct to standard closure techniques for reinforcement and protection of gastrointestinal anastomoses.
Device is an adjunct device and will be applied following standard colon resection surgery and creation of primary anastomosis; Seal-G MIST is a surgical sealant intended for use as an adjunct to standard closure techniques for reinforcement and protection of gastrointestinal anastomoses.
Device is an adjunct device and will be applied following standard colon resection surgery and creation of primary anastomosis
Other intervention name(s): Seal-G; Seal-G MIST
Intervention model: Single Group Assignment
Intervention model description: Seal-G Product Family variants will be used as the study device (Treatment) according to the following scheme:
Seal-G Surgical Sealant [Seal-G]- will be applied on colonic anastomosis created by extra-corporal approach.
Seal-G MIST System [Seal-G MIST]- will be applied on colonic anastomosis created by intra-corporal approach.
Intended Use: Seal-G/Seal-G MIST are surgical sealants intended for use as an adjunct to standard closure techniques for reinforcement and protection of gastrointestinal anastomoses.
Device is an adjunct device and will be applied following standard colon resection surgery and creation of primary anastomosis
Masking: None (Open Label)
Primary purpose: Supportive Care
A Phase II Study of Cetuximab Plus Irinotecan in Patients With EGFR-detectable Metastatic Colorectal Carcinoma
Condition: Colorectal Carcinoma
MeSH terms: Carcinoma; Colorectal Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      To evaluate the response rate of cetuximab plus irinotecan combination therapy in subjects
      with EGFR-detectable metastatic colorectal carcinoma who have documented progressive disease
      to irinotecan-based chemotherapy and who have failed (progressive disease or intolerance)
      previous oxaliplatin-based and fluoropyrimidine-based chemotherapies.
    


Intervention name(s): Cetuximab
Intervention type(s): Drug
Intervention MeSH terms: Cetuximab
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: EGFR-detectable metastatic colorectal carcinoma with documented progressive disease to irinotecan-based chemotherapy and failure
Accuracy of Holladay 2 Formula in the Absence of Lens Thickness
Condition: Cataracts
MeSH terms: Cataract; Aphakia
Study type: Interventional

Summary: 
      Hypothesis: Holladay 2 formula is still accurate even used without lens thickness data.
    


Intervention name(s): optical biometric measurement (IOLMaster)
Intervention type(s): Device
Intervention description(s): IOLMaster version 5.4 was used to measure the patients' optical biometry by non contact technique.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Sugammadex vs Placebo to Prevent Residual Neuromuscular Block
Condition: General Surgery
MeSH terms: Delayed Emergence from Anesthesia
Study type: Interventional
Phase: Phase 4

Summary: 
      The study is designed to determine whether patients who receive sugammadex immediately after
      tracheal extubation will exhibit a decrease in the incidence of postoperative residual
      paralysis and an associated decrease in the incidence of postoperative respiratory
      depression.
    


Intervention name(s): Sugammadex; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Sugammadex will be administered intravenously at 2 mg/kg after routine reversal of anesthesia is performed and subject is extubated.; Placebo will be administered intravenously at 2 mg/kg after routine reversal of anesthesia is performed and subject is extubated.
Other intervention name(s): Bridion
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Postoperative respiratory depression; Neuromuscular Agents
Mindfulness for Irritable Bowel Syndrome
Condition: Irritable Bowel Syndrome
MeSH terms: Irritable Bowel Syndrome; Syndrome
Study type: Interventional

Summary: 
      This study investigates the effectiveness of a 6 week mindfulness intervention in reducing
      symptoms of Irritable Bowel Syndrome (IBS). All Participants will receive treatment.
      Participants will be randomly allocated to an immediate treatment group and a waiting list
      control group.
    


Intervention name(s): Mindfulness Based Cognitive Therapy (MBCT); Waiting Period
Intervention type(s): Behavioral; Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: IBS