bioihbjkbjnl/mcl2 huggingface dataset:
Impact of Intrathecal Morphine on Sleep Apnea Syndrome
Condition: Sleep Apnea Syndromes
MeSH terms: Apnea; Sleep Apnea Syndromes; Syndrome
Study type: Interventional
Phase: Phase 4

Summary: 
      Intrathecal morphine is commonly used as an analgesic adjunct for hip arthroplasty performed
      under spinal anaesthesia. Sleep apnea syndrome is a condition that affects up to 10% of the
      patients. Effect of intrathecal hydrophilic opioids on the frequency and duration of apneic
      episodes is unknown. The objective of this randomised controlled trial is to investigate the
      effect of intrathecal morphine and surgery on apneic episodes.
    


Intervention name(s): Bupivacaine with normal saline; Bupivacaine with intrathecal morphine
Intervention type(s): Drug; Drug
Intervention description(s): Isobaric bupivacaine 15 mg + normal saline 0.5 cc; Isobaric bupivacaine 15 mg + intrathecal morphine 100 mcg
Intervention MeSH terms: Morphine; Bupivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Other
Wide Use of Paperless Partograph in Evaluation of Labour
Condition: Labor Complication; Labor Pain
MeSH terms: Obstetric Labor Complications; Labor Pain
Study type: Observational

Summary: 
      Paperless partograph wide using in labour room as simple tool in evaluation of labour
    

Detailed description: 
      Both world health organization ( WHO) PARTOGRAPH and modified world heath organization
      (WHO)PARTOGRAPH are too long labour tools in evaluation of labour so we need simple tool in
      evaluation of labour
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        the collected data wail be analyzed using the statistical package for social science
        (version 10.0 for windows,SPSS.
      
Biospecimen description: 
      Inside labour room we record that when the labour women in active phase as cervical
      dilatation 4cm or more
    
Keywords: pregnancy.obstructed labour
Transcriptomic Evaluation of Endometrial Receptivity
Condition: Infertility, Female
MeSH terms: Infertility; Infertility, Female
Study type: Observational

Summary: 
      The purpose of this study is to comprehensively evaluate the transcriptomic signal of the
      endometrium before, during, and after the window of receptivity.
    

Detailed description: 
      Phase 1 will aim to define a normal endometrial transcriptomic signature in healthy controls
      without infertility. Phase 2 will elucidate endometrial transcriptomic expression in patients
      with diagnoses of infertility unrelated to endometrial factor. Findings from this phase will
      be compared to the results of phase 1.
    

Intervention name(s): Endometrial biopsy
Intervention type(s): Other
Intervention description(s): All groups will undergo a mock frozen embryo transfer cycle with an endometrial biopsy being performed as opposed to an embryo transfer
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Phase 1:

        Healthy volunteers without a history of infertility will be recruited for the first phase
        to undergo an endometrial biopsy on a randomized cycle day surrounding the window of
        implantation

        Phase 2:

        Healthy volunteers with a history of infertility but without concern for endometrial
        dysfunction will be recruited for the second phase to undergo an endometrial biopsy during
        a preparatory IVF cycle.
Effect of Rosuvastatin in Intracerebral Hemorrhage
Condition: Intracerebral Hemorrhage; Stroke
MeSH terms: Cerebral Hemorrhage; Hemorrhage
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine whether rosuvastatin is effective in the management
      of acute phase of intracerebral hemorrhage and if it impact outcome by NIHSS.
    

Detailed description: 
      The intracerebral hemorrhage (ICH) is a frequent problem of health, with high
      morbid-mortality. In addition it originates expensive expenses in health care systems.

      ICH produces damage by mass effect, then by biochemical ways which are activated and they
      carry to secondary damage. Many studies have been conducted for explaining secondary injury,
      now we know there are ischemic changes related maybe with changes in cerebral flow and
      metabolism, in addition to activate inflammatory ways. Many drugs and measures has been
      ineffective for getting best outcome, without success.

      Statins or inhibitors of HMG CoA reductase are drugs used in dyslipidemia, frequently for
      reduction in LDL. Experimental and clinical studies in stroke and ICH have shown improvement
      in outcome. The toxicity related to statin is myopathy and hepatopathy, both with low
      incidence without fatal cases. Rosuvastatin has been postulated be the most powerful with
      longest life and toxicity similar to another statins.

      We have designed this study to demonstrate if the administration of rosuvastatin in the first
      24 hours and by 14 days has improvement in outcome.
    

Intervention name(s): Rosuvastatin
Intervention type(s): Drug
Intervention description(s): 20 mg 10 days daily
Other intervention name(s): Crestor
Intervention MeSH terms: Rosuvastatin Calcium
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: intracerebral hemorrhage; statins; rosuvastatin; stroke
Human Immune Responses Smallpox
Condition: Smallpox
MeSH terms: Smallpox
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to attempt to identify the immune response of healthy adults to
      an investigational dilution of the Dryvax smallpox vaccine. In addition, we will try to
      determine whether certain genetic characteristics influence the size of the sore around the
      vaccination site, and use blood samples from subjects in the study to make a new form of
      antibody that could be given to people with vaccine side effects.
    

Detailed description: 
      Smallpox is a very serious disease that is fatal in about 1 in 3 patients. Smallpox does not
      exist naturally in the world, and there have been no cases of smallpox in the world since
      1980. Smallpox can be prevented through the use of a very effective vaccine called vaccinia
      virus (Dryvax). After the world was considered free of smallpox, the production of smallpox
      vaccine was discontinued, but due to the recent concern that the smallpox virus may be used
      as a means of bioterrorism, the production of the smallpox vaccine may be restarted. Although
      Dryvax is known to be an effective vaccine for the prevention of smallpox, very little is
      known about the ability of the body to develop defenses to prevent disease (immune responses)
      with this vaccine. As new vaccines for preventing smallpox are developed, it will be
      important to compare the immune responses they cause to the responses that occur with the
      standard vaccine, Dryvax.
    

Intervention name(s): Dryvax
Intervention type(s): Biological
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Treatment of Social Anxiety in Youth
Condition: Social Anxiety Disorder
MeSH terms: Anxiety Disorders; Phobia, Social
Study type: Interventional

Summary: 
      This research is designed to determine the effectiveness of attention bias modification for
      socially anxious children and adolescents. Over the course of 3 years, 50 youth will be
      enrolled in the trial.
    

Detailed description: 
      The primary objective of this study is to develop an Attention Training (AT) protocol for
      adolescents with social anxiety disorder (SAD). Attentional biases to threat have been shown
      to be associated with the development and maintenance of anxiety disorders, in both adults
      and youth. Given these relations, AT paradigms have been developed to modify these
      attentional biases. Such paradigms have been shown to be promising in the treatment of adult
      anxiety. However, to date, only two small studies have examined the use of AT with children,
      and no ATT protocol has been developed specifically for use with children or adolescents.
      This is important, given the complications and possible ineffectiveness of applying
      adult-designed therapies to youth. Given this gap in the literature, the primary aims of the
      current study are intended to develop a treatment program to address attentional biases and
      anxiety in adolescents with SAD, to collect preliminary data regarding the program's
      short-term efficacy and feasibility, and to explore attention biases as a mediator and
      moderator of initial treatment outcomes. It is hypothesized that the AT protocol developed in
      the current project, compared to a placebo control comparator condition, will result in
      reductions in social anxiety among a sample of adolescents with SAD. Further, the AT protocol
      is expected to reduce attentional biases to threat among those adolescents who possess such
      biases prior to treatment (not all adolescents are expected to show this bias yet AT has been
      shown to be potentially effective with these youth; the presence/absence of attention bias
      will be explored as a moderator of change). The proposed study will be a pivotal step towards
      assessing the feasibility of an adolescent-focused AT procedure for the treatment of SAD.
      Results will contribute to an emerging body of research exploring the ameliorating effects of
      experimental paradigms that target information processing biases in anxious youth. Given
      emerging evidence regarding the use of AT in adult populations, findings from this study may
      have implications for improving the current prevention and treatment options available for
      anxious adolescents.
    

Intervention name(s): Attention Bias Modification
Intervention type(s): Behavioral
Intervention description(s): Computer delivered modification in 80% of trials
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
A Soft Silicone Wound Contact Layer Containing Silver in the Treatment of Skin Grafts in Surgical Burn Patients.
Condition: Burn Injury; Skin Graft
MeSH terms: Burns
Study type: Interventional

Summary: 
      Part A The primary objective of Part A will be to verify performance and safety of Mepitel®
      Ag, a meshed, non- adherent soft silicone wound contact layer containing silver in the
      treatment of skin grafts in surgical burn patients.

      Part B The primary objective of Part B will be to examine the usefulness of Mepilex® Transfer
      Ag as an adequate option for donor site healing.
    

Detailed description: 
      This post market clinical follow-up investigation is designed as an open, non-controlled,
      multi- centre, clinical investigation.

      A total of approximately 25 subjects from among 4-6 clinical investigative sites will be
      evaluated providing they fulfill all the inclusion criteria and none of the exclusion
      criteria. A signed and dated informed consent/assent will be obtained for all subjects.

      Subjects to be included will present with a thermal burn injury that will require skin
      grafting and result in a donor site. Overall percent Total Body Surface Area (%TBSA) burned
      will not exceed 30%.

      The subjects will be consecutively allocated to a subject code providing they fulfill all
      inclusion criteria and none of the exclusion criteria and have signed a written consent.

      The subjects were participating in the study for 14 days postop.
    

Intervention name(s): Mepitel® Ag; Mepilex® Transfer Ag
Intervention type(s): Device; Device
Intervention description(s): A soft silicone wound contact layer that allows exudates to pass vertically into a secondary absorbent dressing. The product provides fixation and protection of the tissues and has antimicrobial properties.
This silicone net dressing will be used to prevent lifting and adherence of skin grafts to the dressings, as well as to prevent pain, and promote healing.; Mepilex® Transfer Ag is a soft silicone wound contact layer that absorbs and transfers exudate, maintains a moist wound healing environment and has antimicrobial properties.
Mepilex® Transfer Ag consists of a Safetac® adhesive layer and compressed polyurethane foam containing silver sulphate and activated carbon. Safetac® is a unique adhesive technology that minimizes pain to patients and trauma to wounds and the surrounding skin. It minimizes risk for maceration by sealing the wound margins; ensuring exudate does not spread to the surrounding skin.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: Two Parts (part A and B) with one dressing device for the skin graft placed on a surgical burn wound and another dressing device placed on the donor site.
Masking: None (Open Label)
Primary purpose: Treatment
A Safety and PK Study of IV Eravacycline
Condition: Bacterial Infections
MeSH terms: Infections; Bacterial Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a Phase 1, open-label, multi-center study to determine the pharmacokinetics and
      safety of intravenous Eravacycline in Children with Suspected or Confirmed Bacterial
      Infection. Male and Female subjects from 8 to <18 years of age who fulfill the
      inclusion/exclusion criteria will be enrolled in this study.
    

Detailed description: 
      This is a Phase 1, open-label, single dose study to evaluate PK, safety, and tolerability of
      IV eravacycline in children with suspected or confirmed bacterial infection who are receiving
      systemic antibiotic therapy, other than eravacycline. The study design will allow for
      evaluation of PK and safety of IV eravacycline in a pediatric population at exposures
      predicted to be comparable to those already studied in adults. The study design is depicted
      in Figure 1.

      Two cohorts defined by age group will be enrolled simultaneously:

        -  Cohort 1: 12 to <18 years of age (adolescents)

        -  Cohort 2: 8 to <12 years of age (younger children) Eravacycline will be administered as
           a single IV dose using the optimum dosage determined from PK-PD modeling and model-based
           simulations of phase 1, 2, and 3 adult data. Blood samples will be collected for PK
           analysis at predetermined timepoints.
    

Intervention name(s): Eravacycline (TP-434)
Intervention type(s): Drug
Intervention description(s): Subjects will be stratified by age into 2 cohorts, as follows:
Cohort 1: from 12 to <18 years of age (N=8)
Cohort 2: from 8 to <12 years of age (N=12 or at least 60% of subjects)
Other intervention name(s): Trade name: Xerava™
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Drug-Drug Interaction Study of Furosemide and PA21
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine if Furosemide is affected by PA21.
    


Intervention name(s): PA21 and Furosemide with food; No PA21; Furosemide with food; PA21 with food and Furosemide 2hrs later
Intervention type(s): Drug; Drug; Drug
Intervention description(s): The maximum dose of PA21 will be 15.0 g/day. The maximum dose of Furosemide will be 40 mg/day; The maximum dosage of Furosemide will be 40 mg/day; The maximum dose of PA21 will be 15 g/day. The maximum dose of Furosemide will be 40 mg/day
Intervention MeSH terms: Furosemide
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Drug-drug interaction; Pharmacokinetics; PA21; Drug Interaction Potentiation
The Effect of Gelesis100 on the Pharmacokinetics of Metformin
Condition: Healthy Overweight Obese
MeSH terms: Overweight
Study type: Interventional

Summary: 
      The purpose of this study is to determine the effect of Gelesis100 on the absorption of
      metformin both with and without a meal.
    


Intervention name(s): Gelesis100; Metformin
Intervention type(s): Device; Drug
Intervention description(s): 3 capsules each containing 0.75 mg; 1 tablet of 850 mg
Other intervention name(s): Glucophage
Intervention MeSH terms: Metformin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Effectiveness of Vapocoolant Spray on Venipuncture Pain in Young Male Donors
Condition: Venipuncture; Pain
Study type: Interventional

Summary: 
      Aim: The aim of this study is to assess the effectiveness of vapocoolant spray in reducing
      pain related to venipuncture in young, healthy male blood donors.

      Hypotheses:

      H1: Vapocoolant spray reduces venipuncture pain during blood donation. H0: Vapocoolant spray
      does not reduce venipuncture pain during blood donation.
    

Detailed description: 
      After being informed about the study and potential risks, all patients giving written
      informed consent. Before the procedure was begun, the donors who agreed to participate in the
      study were met face-to-face and asked to fill in the "Informative Characteristics Form", the
      "VAS", the "Blood/Injection Fear Scale" and the "STAI-I" forms.Then the donors were assigned
      to their groups by the researcher.The donors in the control group were not given any
      intervention during the blood collection process. Vapocoolant spray was applied to the donors
      in the vapocoolant spray group. During the blood collection procedure, after the donors' skin
      was cleaned with antiseptic solution, spray was applied to the application site for a maximum
      of 10-15 seconds from a distance of 25 cm. In both groups, immediately following
      venipuncture, pain assessment was made with the VAS by the researcher, who did not know which
      group each participant belonged to.
    

Intervention name(s): Vapocoolant spray
Intervention type(s): Other
Intervention description(s): Vapocoolant spray
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: The participants were separated into two groups with the randomisation method.These groups were named the vapocoolant spray group and the control group
Masking: Single (Investigator)
Primary purpose: Supportive Care
Keywords: Vapocoolant Spray; Venipuncture; Pain; Donors
Effectiveness of a Short, Intensive and Standardised Spa Therapy for Low Back Pain on Sick Leave Duration
Condition: Low Back Pain
MeSH terms: Back Pain; Low Back Pain
Study type: Interventional

Summary: 
      The purpose of this study is to determine whether an intensive 5 days long multidisciplinary
      program (including spa therapy, exercises and patients'education) is more effective regarding
      return to work than usual care in subacute and chronic low back pain for people in sick leave
      from 4 to 24 weeks duration, and for which an extension of sick leave is considered
    

Detailed description: 
      Sick leave due to low back pain (LBP) is costly and compromises workforce productivity. Sick
      leave itself, fears and believes regarding return to work, and a low self-esteem have been
      identified as independent predictors of extended sick leave. Previous data suggested that
      multidisciplinary rehabilitation programs, including physical activities and psychobehavioral
      management, should decrease sick leave duration in chronic LBP. However these programs are
      heavy (at least 4 weeks long), and are often proposed to patients at the end of the
      management (over 6 months after the beginning of symptoms). Another approach could be to
      propose a shorter multidisciplinary program (for example 5 days long), earlier in the history
      of LBP to break the vicious circle as soon as possible. The target population could be people
      suffering from subacute LBP with sick leave duration between 4 and 24 weeks.
    

Intervention name(s): Spa therapy, exercise and educational therapy; Usual care
Intervention type(s): Other; Other
Intervention description(s): During 5 days: Spa therapy (2 hours/day), exercises (30 min/day), educational therapy (45 min/day) including education on physical activities, work, and pain management; Information, counseling, treatment usually provided for sub-acute and chronic low back pain and the back book
Other intervention name(s): multidisciplinary program
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Subacute low back pain; Chronic low back pain; Low back pain; Disability; Education; Exercise; Spa therapy; Physiotherapy; Multidisciplinary; Cost-effectiveness; Sick leave
Early Pregnancy Failure: Factors Affecting Successful Medical Termination Treatment
Condition: Early Pregnancy Failure
Study type: Observational

Summary: 
      The main purpose of our study was to which determine factors, those measured by ultrasound
      and also demographic and clinical factors (age, number of previous pregnancies, abortions and
      deliveries) predict outcome of medical treatment for early pregnancy failure. Our hypothesis
      was that gestational sac volume predicts outcome of medical treatment for early pregnancy
      failure.
    


Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Women with missed abortion or anembryonic pregnancy, with existing intrauterine pregnancy
        sac
      
Keywords: Early pregnancy failure; Misoprostol; Gestational sac volume