bioihbjkbjnl/mcl2 huggingface dataset:
Phase 1 Clinical Trial of Varenicline in Chinese Healthy Smoking Volunteers
Condition: Smoking
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is to measure how much of varenicline tartrate is in Chinese healthy smokers'
      blood and urine after taking a single dose and several doses respectively, and also to test
      the safety (the impact of the study drug on Chinese healthy smokers' body) of varenicline.
    


Intervention name(s): varenicline tartrate
Intervention type(s): Drug
Intervention MeSH terms: Varenicline
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Intra-uterine Injection of Human Chorionic Gonadotrophin (hCG) Before Embryo Transfer
Condition: Infertility
MeSH terms: Infertility
Study type: Interventional
Phase: Phase 4

Summary: 
      Chorionic gonadotrophins (hCG) play an important role in implantation. The aim of the study
      is to evaluate the effect of intrauterine injection of hCG before embryo transfer in IVF/ICSI
      on the implantation and pregnancy rates. The rational is that intrauterine hCG injection will
      attract regulatory T cells and improve implantation.
    

Detailed description: 
      Background :

      Human chorionic gonadotrophin ( hCG) was found to secreted immediately after fertilization by
      the embryo. It plays an important role in implantation and in attracting regulatory T cells
      to the endometrium.

      Rational :

      Intrauterine injection of hCG before embryo transfer in IVF/ICSI may increase endometrial
      regulatory T cells ( Treg ) and improve the implantation and pregnancy rates.

      Aim of the work :

      To study the effect of intrauterine injection of hCG before embryo transfer on the
      implantation and pregnancy rates after IVF/ICSI.

      Subjects :

      Infertile patients undergoing ICSI.

      Inclusion criteria :

        -  Female age less than 40 years

        -  Male factor infertility

        -  Normal female hormonal profile and uterine cavity

      Exclusion criteria :

        -  Previous ICSI failure

        -  Azoospermia

        -  Endometriosis

      Study group: Intrauterine injection of 100 iu of hCG (group 1)or 200 iu of hCG ( group 2)
      will be done during the dummy embryo transfer which is done 10-15 minutes before the actual
      embryo transfer.

      Control group: The embryo transfer will be done without prior intrauterine injection of hCG

      Main outcome measures :

      Implantation and pregnancy rates

      Secondary outcome measures :

      miscarriage and delivery rates
    

Intervention name(s): human chorionic gonadotrophin
Intervention type(s): Drug
Intervention description(s): intrauterine injection of 100 iu (group1) or 200 iu (group2) of hCG before embryo transfer in IVF/ICSI And intrauterine injection of 500 iu hCG before embryo transfer .
Other intervention name(s): choriomon
Intervention MeSH terms: Chorionic Gonadotropin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: hCG; pregnancy; implantation; ICSI; IVF
iCBT and ABM for Reducing Depressive Symptoms in Firefighters
Condition: Depression
MeSH terms: Depression
Study type: Interventional

Summary: 
      The study aimed to examine the impact of a combined internet-delivered Cognitive Behavioral
      Therapy (iCBT) and Attention Bias Modification (ABM) intervention to reduce depressive
      symptoms in firefighters. The study was a randomized controlled trial carried out in Kunming,
      China, and involved the recruitment of 138 active firefighters as participants. The
      intervention lasted for an 8-week duration, during which participants participated in ABM
      exercises on alternating days and concurrently underwent four modules of iCBT courses
      delivered through a smartphone application.
    


Intervention name(s): Internet-delivered Cognitive Behavioral Therapy; Attention Bias Modification
Intervention type(s): Behavioral; Behavioral
Intervention description(s): iCBT was administered in an unguided fashion without human therapeutic support. Participants were instructed to progress through the eight core modules over an 8-week period. The modules comprised psychoeducational content centered around CBT, aimed at promoting the development of skills such as self-monitoring of emotions, cognitive distancing, cognitive reframing/restructuring, problem-solving, and mindfulness. In the event of technical difficulties during the intervention, participants were able to seek assistance.; The Dot-Probe Paradigm was utilized within the Attention Bias Modification procedure. The training sessions were comprised of 96 trials, which included facial expression photos depicting happiness, neutrality, and sadness, sourced from four male and four female actors. A fixed cross (+) was presented on the computer screen's center for a duration of 500 milliseconds before each stimulus display, followed by the presentation of two images portraying distinct emotional expressions, which persisted for 500 milliseconds. After the disappearance of the images, an arrow appeared in the location where they had been displayed, and participants were instructed to select the arrow that corresponded with the presented arrow. In the ABM procedure, the arrow was consistently presented following the display of a more positive facial expression, such that in the instance of a sad-neutral face pair, the arrow would always appear in the location of the neutral facial expression image.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Ketamine For Acute Treatment of Pain in Emergency Department
Condition: Pain
MeSH terms: Emergencies
Study type: Interventional
Phase: Phase 4

Summary: 
      The aim of the study is to compare the safety & efficacy of low dose ketamine and morphine
      versus morphine alone for acute generalized pain in the Emergency Department (ED). The
      investigators are also interested to investigate whether low-dose ketamine is a safe and
      effective alternative option to opioids for the acute treatment of pain in the Emergency
      Department.

      The agents that are available in the department includes acetaminophen, non-steroidal
      anti-inflammatory (NSAIDS) and opioids. In most cases, acetaminophen and NSAIDS are not
      adequate to manage acute pain crisis. There is also heightening concerns for increased opioid
      use or abuse by patients. Since the HCAPHS survey includes various questions which inquires
      about patient perception of pain management in the department, the investigators are
      interested in investigating the safety and efficacy of low-dose ketamine to as an alternative
      method to opioids for the acute management of pain. There has been limited, mostly
      observational pilot studies, published in the literature. Limited data in the literature have
      reported the incidence of nausea and vomiting ranged from 3-13%. All published literature
      administered low-dose ketamine as an intravenous push. To the best of our knowledge our study
      would be the first study to administer low-dose ketamine as a short bolus infusion to
      mitigate the incidence of nausea and vomiting. The investigators believe our study would
      provide important scientific data to fill the theoretical gap that low-dose ketamine at
      0.3mg/kg/dose may be a safe and effective agent for acute pain management in an ED that is
      located in the center of a densely populated urban area.
    

Detailed description: 
      The aim of the study is to compare the safety & efficacy of low dose ketamine and morphine
      versus morphine alone for acute generalized pain in the Emergency Department (ED). The is a
      randomized double blind placebo controlled trial to investigate the effects of low dose
      ketamine and morphine versus placebo and morphine for the management of acute pain in the ED.
    

Intervention name(s): Ketamine; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Ketamine 0.3mg/kg in 50ml normal saline, administered over 15 minutes; Normal saline 50ml, administered over 15 minutes
Intervention MeSH terms: Ketamine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: analgesia; ketamine; pain
Posterior Tibial Artery Bypass for Iliofemoral Artery Injury Associated With Massive Blood Loss and Shock
Condition: Iliofemoral Artery Injury; Shock
MeSH terms: Shock; Wounds and Injuries
Study type: Observational

Summary: 
      Traumatic disruption of iliofemoral arterial segment is often associated with multiple
      injuries, massive hemorrhage, state of shock, and loss of blood supply to the ipsilateral
      lower extremity, as well as with high mortality.

      The investigators describe a bypass technique. It can provide adequate blood supply to the
      lower extremity of the injury side. Due to a minimum amount of additional blood loss, it is a
      low risk procedure for salvage of the extremity and even patient's life.
    

Detailed description: 
      Patients were selected on the basis of the following: (1) closed injuries to the lower
      abdomen and/or pelvis; (2) serious hemorrhagic shock; (3) loss of blood supply to the
      ipsilateral lower extremity; (4) high-risk emergency artery reconstruction.

      The instruments used to measure sensibility of the foot were the Semmes-Weinstein (SW)
      monofilament test 24 and the static two-point discrimination (2PD) test 25. The
      weight-bearing area of the first metatarsal head and the dorsum of the first metatarsal head
      were assessed. Active range of motion (ROM) of the hip, knee, and ankle joints was measured
      with a goniometer. The muscle strength was test using Medical Research Council (MRC) Scale.
      The cold intolerance of the leg was measured using the self-administered Cold Intolerance
      Severity Score (CISS) questionnaire 26. The maximum score is 100 and is grouped into 4 ranges
      (0-25, 26-50, 51-75, and 76-100) corresponding to mild, moderate, severe, and extreme
      severity, respectively.
    

Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        8 patients
      
Keywords: Posterior tibial artery bypass; Iliofemoral artery injury; Shock; Reconstruction
TOBY (TOtal Body hYpothermia): a Study of Treatment for Perinatal Asphyxia
Condition: Asphyxia Neonatorum; Hypoxia; Encephalopathy; Seizures
MeSH terms: Seizures; Brain Diseases; Asphyxia Neonatorum; Hypoxia; Hypothermia; Asphyxia
Study type: Interventional

Summary: 
      Hypothesis: Prolonged whole body cooling in term infants with perinatal asphyxial
      encephalopathy reduces death and severe neurodevelopmental disability.

      This study aims to determine whether whole body cooling to 33-34°C is a safe treatment that
      improves survival, without severe neurological or neurodevelopmental impairments at 18
      months, of term infants suffering perinatal asphyxial encephalopathy.
    

Detailed description: 
      This is a multicentre prospective randomised controlled trial to determine whether a
      reduction of body temperature by 3-4°C following perinatal asphyxia improves survival without
      neurodevelopmental disability.

      Full term infants will be randomised within 6 hours of birth to either a control group with
      the rectal temperature kept at 37 ± 0.2°C or to whole body cooling with the rectal
      temperature kept at 33.5 ± 0.5°C for 72 hours followed by slow rewarming.

      The outcome will be assessed at 18 months of age by survival and neurological and
      neurodevelopmental testing.

      Eligibility criteria:

      Term infants less than 6 hours after birth with moderate or severe perinatal asphyxia (a
      combination of clinical and EEG criteria).

      Exclusion criteria:

      Infants expected to be 6 hours of age at the time of randomisation or infants with major
      congenital abnormalities.

      Intervention:

      Intensive care with whole body cooling versus intensive care without whole body cooling
      (babies are cooled to 33.5°C for 72 hours)

      Main Outcomes:

      Death and severe neurodevelopmental impairment at 18 months of age

      Secondary Outcomes:

      Cerebral thrombosis or haemorrhage, persistent hypotension, pulmonary hypertension, abnormal
      coagulation, arrhythmia and sepsis in the neonatal period. Neurological impairments at 18
      months

      Number of patients required: 236.

      On 30th November 2006, when recruitment closed, 325 babies had been recruited.
    

Intervention name(s): Whole body mild induced hypothermia
Intervention type(s): Procedure
Intervention description(s): Target rectal temperature 33-34°C for 72 hours, commencing by 6 hours of age; followed by re-warming at 0.5°C to normothermia
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Hypoxia; Ischaemia; Encephalopathy; Neonatal; Hypothermia; Perinatal; Cooling; Whole/Total Body
MiCrobiome dieT Study
Condition: Healthy
Study type: Interventional

Summary: 
      The human gut microbiome is the community of bacteria that reside within the human intestine.
      These microbes are constantly exposed to the end-products and partial break-down-products of
      digestion from the foods consumed each day. Very little is known about the complex
      interaction of specific dietary components with the microbiome over time in one individual.
      In order to produce robust analysis of these interactions, longitudinal samples with detailed
      dietary intake information from healthy human subjects are needed.

      The complex relationship between dietary intake and the microbiome, and the potential health
      implications of human exposure to microbial metabolites, are only beginning to be understood.
      It is well known that altered dietary intake can trigger rapid, although transient, changes
      in the composition of the microbiome in as little as 1 to 2 days. The biggest factors in
      determining microbial response to diet are thought to include an individual's starting
      microbiome, long-term dietary habits, and environmental exposures.

      It is not well understood how small dietary differences from day-to-day impact the
      microbiome. A longitudinal dataset with accurately recorded dietary data and multiple samples
      over 17 days will provide valuable insight into the changes that occur at the individual
      level over time, while controlling for dietary trends and initial microbiome composition.

      Medium chain triglycerides (MCTs) have systemic beneficial effects and increase survival in
      rats by preventing gut injury and permeability following lipopolysaccharide administration,
      preventing alcohol-induced liver injury, and protecting against the development of colitis in
      a model of Crohn's disease. Understanding the interaction of MCTs with the microbiome in
      humans could lead to important advancements in the understanding of how diet impacts the
      microbiome composition, and ultimately, human health. This proposed study is designed to
      evaluate the effect of MCTs compared with long chain triglycerides on the normal structure of
      the microbiome and data will not be used to diagnose, prevent, cure or treat disease.

      The purpose of this study is to: 1) investigate the role daily dietary variation plays in
      microbiome composition and stability, and 2) explore the effect of MCT supplementation on
      microbiome composition in healthy adults.
    


Intervention name(s): Medium chain triglycerides; Long chain triglycerides
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Gel capsules, each containing 1 gram; Gel capsules, each containing 1 gram
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Basic Science
Keywords: Microbiome
BI 207127 / Faldaprevir Combination Therapy in Hepatic Impairment (Child-Pugh B) Patients With Genotype 1b Chronic Hepatitis C Infection: HCVerso3
Condition: Hepatitis C, Chronic
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis
Study type: Interventional
Phase: Phase 2

Summary: 
      To assess the pharmacokenetic characteristics of 600 mg BID BI 207127 / 120 mg QD faldaprevir
      /ribavirin in a small number of GT1b HCV infected patients with mild hepatic impairment (CPA)
      (Arm 1) versus 400 mg BID BI 207127 / 120 mg QD faldaprevir /ribavirin in a small number of
      GT1b HCV infected patients with moderate hepatic impairment (CPB) (Arm 2).
    


Intervention name(s): Ribavirin; BI 207127 high dose; Faldaprevir; Ribavirin; BI 207127 low dose; Faldaprevir
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): 24 Weeks; 24 Weeks; 24 Weeks; 24 Weeks; 24 Weeks; 24 Weeks
Intervention MeSH terms: Ribavirin
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
IDB Injection Combined With PTNS for Managing Children With OAB Not Responding to Monotherapy
Condition: BOTOX; Percutaneous Tibial Nerve Stimulation
Study type: Interventional

Summary: 
      This study aimed to evaluate the outcome of simultaneous intradetrusor BOTOX (IDB) injection
      and Percutaneous tibial nerve stimulation (PTNS) for management of children with recurrent
      wetness since at least 6 months.
    

Detailed description: 
      Overactive bladder is a syndrome characterized by symptoms of urgency, with or without
      urgency incontinence, usually with increased daytime frequency and nocturia. The Neurogenic
      or myogenic bladder dysfunction can lead to the symptoms that characterize Overactive
      bladder. Normal bladder contraction occurs when the muscarinic receptors in the detrusor
      muscle are stimulated with acetylcholine. Although the pathogenesis of Overactive bladder is
      not fully explained; sensitization of afferent nerves, deactivation of inhibitory mechanisms,
      and the emergence of contractions similar to primitive voiding reflexes are shown as
      pathogenetic mechanisms. Another hypothesis is that the number of intercellular connections
      among detrusor myocytes increase, and these cells are spontaneously stimulated.

      In addition to the fact that the etiopathogenesis cannot be explained clearly and due to the
      intense relationship with the autonomic nervous system, undesirable systemic side effects are
      common in treatments applied.
    

Intervention name(s): Solifenacin group; Percutaneous tibial nerve stimulation group; Intradetrusor BOTOX group; Intradetrusor BOTOX combined with Percutaneous tibial nerve stimulation group
Intervention type(s): Drug; Procedure; Drug; Combination Product
Intervention description(s): Patients in this group will receive medical treatment (Solifenacin 5 mg once or twice daily) without any second line of treatment; Patients in this group will receive Percutaneous tibial nerve stimulation after failure of medical therapy; Patients in this group will receive Intradetrusor BOTOX after failure of medical; Patients in this group will receive Intradetrusor BOTOX combined with Percutaneous tibial nerve stimulation after failure of medical
Intervention MeSH terms: Solifenacin Succinate; Botulinum Toxins, Type A; abobotulinumtoxinA
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Overactive Bladder
Safety Evaluation of Adverse Reactions in Diabetes
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to assess the effects of incretin-based antidiabetic therapies
      (DPP-4 inhibitors and GLP-1 agonists) on cardiovascular, gastrointestinal and renal system
      and to detail the mechanisms underlying their action in these systems.
    


Intervention name(s): Exenatide; Linagliptin; Gliclazide
Intervention type(s): Drug; Drug; Drug
Intervention MeSH terms: Exenatide; Linagliptin; Gliclazide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Safety Study of Acellular Adipose Tissue for Soft Tissue Reconstruction
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess the safety and tolerability of acellular adipose
      tissue (AAT), intended for the repair of soft tissue defects in humans, in healthy
      volunteers. The investigators hypothesize that AAT will be safe and well tolerated upon
      injection into human soft tissue.
    

Detailed description: 
      This is a 12-week, prospective, Phase I study in healthy volunteers assessing the safety and
      tolerability of acellular adipose tissue (AAT) intended for the repair of soft tissue defects
      in humans. Up to five (5) 2 milliliters (mL) subcutaneous injections of AAT will be
      administered into redundant tissues previously identified and scheduled for surgical removal
      in an elective surgical procedure.

      Participants will be enrolled and assigned chronologically to one of five excision time
      points: Weeks 2, 4, 6, 8, and 12 post-injection. Implants will be injected on Day 0. A safety
      visit will occur at 1 week post-injection; follow-up visits will occur at Weeks 2 and 4 (for
      patients who still have implants) post-injection and at time of tissue excision. At the end
      of their assigned study time point, participants will have all AAT implants removed
      simultaneously during their elective surgery. Implants will be assessed using
      histopathological analyses including hematoxylin and eosin staining and flow cytometry. The
      primary outcome of safety will be determined by the incidence and rate of adverse /
      unanticipated events. Secondary outcomes include histopathological assessment of the
      explanted implants and tolerability determined by participant-reported comfort and
      physician-reported ease-of-use with the intervention.
    

Intervention name(s): Acellular Adipose Tissue (AAT)
Intervention type(s): Biological
Intervention description(s): The components of the adipose-derived scaffold are all naturally occurring AAT proteins and proteoglycans that provide a natural scaffold. The nature of the AAT also enhances host tissue integration since matrix components can be easily degraded by cell-secreted enzymes as tissue remodeling takes place. Mechanisms for matrix turnover are already established in host cells, avoiding any concerns over proper clearance of scaffold materials from the body.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Abdominoplasty