bioihbjkbjnl/mcl2 huggingface dataset:
Temporally Splitting Ovarian Stimulation and Embryo Transfer
Condition: Splitting of Ovarianstimulation and Embryotransfer
Study type: Observational

Summary: 
      The purpose of this study is to explore the concept of temporally splitting ovarian
      stimulation and embryo transfer.
    


Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        women with indication for ART with ICSI or IVF
      
Keywords: vitrification; ovarian stimulation; reproductive medicine
Parafunctional Habits and Temporomandibular Disorder in Adolescents
Condition: Temporomandibular Disorder; Adolescent Behavior
MeSH terms: Temporomandibular Joint Disorders; Temporomandibular Joint Dysfunction Syndrome
Study type: Observational

Summary: 
      The disorders that affect the temporomandibular joint (TMJ) are responsible for the diverse
      symptoms. Objective: To evaluate whether or not the relationship between signs or symptoms of
      TMD and presence of harmful habits. The investigators evaluated 244 adolescents enrolled in
      public school . The investigators used the questionnaire for selection of orofacial pain and
      temporomandibular disorders, recommended by American Academy of Orofacial Pain to assess the
      presence or absence of signs and symptoms of TMD.
    

Detailed description: 
      For the assessment of signs and symptoms of TMD and parafunctional habits, 244 adolescents
      between 10 and 20 years of age and enrolled in a municipal school system were analyzed. The
      participants were submitted to the self-explanatory questionnaire for screening recommended
      by the American Academy of Orofacial Pain for the determination of orofacial pain and TMD.
      This questionnaire is made up of ten guided questions with yes or no responses to the most
      frequent signs and symptoms of orofacial pain and TMD. According to the Academy, three or
      more affirmative responses are an indication of TMD. Patient history and a detailed clinical
      exam were performed for the assessment of the presence or absence of parafunctional habits.

      The frequency of signs and symptoms was analyzed and the data were described based on gender
      and age. The SPSS 12.0 program was used for the statistical analysis and the data were
      treated using the chi-square test.
    

Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        244 adolescents between 10 and 20 years of age and enrolled in a municipal school system.
      
Keywords: temporomandibular disorder; adolescents
Mind Body Intervention for Chronic Lower Back Pain
Condition: Chronic Lower Back Pain
MeSH terms: Back Pain; Low Back Pain
Study type: Interventional
Phase: Phase 3

Summary: 
      This pilot study will evaluate the feasibility of having a non-behavioral health provider
      deliver a combination of manual therapy (MT) and cognitive behavioral therapy for pain
      (CBT-p). In addition, we will evaluate differences in outcomes in patients undergoing the
      combined intervention of CBT-p and MT and those undergoing MT alone.
    

Detailed description: 
      Given that this is a pilot study we will use simple descriptive statistics for patient
      characteristics, including age, sex, BMI and baseline scores on outcome measures. In addition
      we will assess the inter-rater reliability of the scoring of the delivery of the CBT-p by the
      two trained practitioners utilizing kappa statistics. We will perform data analyses using
      SPSS.
    

Intervention name(s): Manual Therapy; Mind Body Intervention
Intervention type(s): Procedure; Procedure
Intervention description(s): Manual Therapy Arm; Combination of manual therapy and cognitive behavioral therapy for pain.
Other intervention name(s): Spinal Manipulative Therapy; Spinal Mobilization; Flexion Distraction Therapy; Manual Therapy; Cognitive Behavioral Therapy for Pain
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Chronic Lower Back Pain; Manual Therapy; Cognitive Behavioral Therapy
Intracoronary Tirofiban on No-Reflow Phenomena
Condition: No-Reflow Phenomenon
MeSH terms: No-Reflow Phenomenon
Study type: Interventional
Phase: Phase 4

Summary: 
      The goal of this study was to evaluate the acute effect of intracoronary administration of
      tirofiban on no-reflow phenomenon in patients with STEMI and occurrence of no-reflow
      phenomenon undergoing primary percutaneous coronary intervention (PCI).
    

Detailed description: 
      The no-reflow phenomenon is one of the most common causes of adverse cardiovascular events in
      patients with ST-elevated myocardial infarction (STEMI). Re-canalization of infarct related
      arterial (IRA) flow related to better ventricular performance and lower mortality rate in
      patients with STEMI. In addition, no-reflow phenomena may limit the benefits of
      re-canalization of the IRA.

      In recent years, many mechanical or pharmacological treatment strategies including adjunctive
      administration of glycoprotein IIb/IIIa inhibitors (GPI) have been proposed in patients with
      STEMI. Although current guidelines recommend that small molecule GPI should be administered
      as an upstream bolus followed by a continuous infusion in patients with STEMI, changes in
      clinical practice may obviate the need for GPI dosage or routes in current practice. Previous
      studies have shown that intravenous and intracoronary administration of GPI improve the
      prognosis and significantly reduce mortality in patients with STEMI. Recently, the Ongoing
      Tirofiban in Myocardial infarction Evaluation-2 (ON-TIME 2) trial found that the use of
      tirofiban started during the pre-hospital phase as upstream therapy for primary percutaneous
      coronary intervention (PCI) and continued for up to 18 hours infusion after the procedure
      showed an improvement in the markers of reperfusion. Additionally, a reduction was
      demonstrated in the death in recurrent myocardial infarction in urgent target vessel
      revascularization and thrombotic bailout. However, in the current literature there are
      insufficient data regarding the role of intracoronary administration of GPI inhibitors in
      patients with STEMI who developed the no-reflow phenomenon. The goal of this study was to
      evaluate the acute effect of intracoronary administration of tirofiban on no-reflow
      phenomenon in patients with STEMI and occurrence of no-reflow phenomenon undergoing primary
      PCI.
    

Intervention name(s): Tirofiban; Placebo
Intervention type(s): Drug; Other
Intervention description(s): Intracoronary administering of Tirofiban; Intracoronary serum physiologic
Other intervention name(s): Glycoprotein IIb/IIIa inhibitor
Intervention MeSH terms: Tirofiban
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: No-reflow phenomenon, tirofiban, intracoronary
The Effect of NHE and KT on the Hamstring Strength and Sprint Performance in Collegiate Sprinters
Condition: Hamstring Injury
Study type: Interventional

Summary: 
      The invesitgators performed a randomized controlled trial on collegiate sprinters to explore
      the combined effect of the NHE and KT and randomly allocated the subjects into the
      experimental (NHE+KT) or control (NHE) group by an independent researcher using the sealed
      envelopes method.

      To calculate the sample size, a Cohen's d effect size of 0.4, an alpha level of 0.05, a test
      power of 0.95 were configured to G*Power software, at least 34 samples were computed.
      Considering the dropouts, 40 male collegiate sprinters were enrolled, explained the
      procedures of this study and voluntarily written informed consent. Inclusion criteria was
      that participants must be male, aged 18 years or older, training at the university level at
      least 4 times per week, with no history of lower limb injury within the last 6 months and no
      previous experience of the NHE or KT. Participants who had lower limb mobility limitation or
      injury especially HSI within 6 months and associated musculoskeletal, respiratory or
      cardiovascular diseases and was allergic to kinesio tape were excluded.
    


Intervention name(s): NHE+KT; NHE
Intervention type(s): Other; Other
Intervention description(s): the Nodic hamstring exercise plus the kinesio taping with tension during 4-week consisting 12 sessions; the Nodic hamstring exercise plus the kinesio taping without tension during 4-week consisting 12 sessions
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention
An Open-Label Study of Aripiprazole Lauroxil in Subjects With Stable Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will evaluate the safety, tolerability, and pharmacokinetics (PK) of various doses
      and dosing intervals of aripiprazole lauroxil.
    


Intervention name(s): Aripiprazole Lauroxil
Intervention type(s): Drug
Intervention description(s): Gluteal IM injection, given once every 4 to 8 weeks
Intervention MeSH terms: Aripiprazole; Aripiprazole lauroxil
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Alkermes; Schizophrenia; Aripiprazole; Aripiprazole lauroxil; ALKS 9072
The Pharmacokinetics of Ketorolac Tromethamine Administered Intranasally (IN) for Postoperative Pain in Children Aged 12 Through 17 Years
Condition: Postoperative Pain
MeSH terms: Pain, Postoperative
Study type: Interventional
Phase: Phase 1

Summary: 
      This was an open-label PK study in pediatric subjects who had undergone general surgery. Each
      subject's study participation consisted of a screening visit, a single-dose treatment with
      intranasal ketorolac (IN) tromethamine, and a follow-up visit.

      Following surgery, subjects received IN ketorolac 15 mg (weight < 50 kg) or 30 mg (weight >
      or = 50 kg) when pain relief was indicated. For pain not relieved by the study drug, the
      subjects had access to an opioid analgesic administered by patient-controlled analgesia
      (PCA). Blood samples for pharmacokinetic analysis were obtained at specified time points
      following the dose of ketorolac.
    


Intervention name(s): Ketorolac Tromethamine; Ketorolac Tromethamine
Intervention type(s): Drug; Drug
Intervention description(s): Single IN dose of 15 mg ketorolac tromethamine for subjects weighing <50 kg.; Single IN dose of 30 mg ketorolac tromethamine for subjects weighing ≥50 kg.
Intervention MeSH terms: Ketorolac; Ketorolac Tromethamine
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Zinc Versus Multivitamin Micronutrient Supplementation in the Setting of COVID-19
Condition: Healthy; Health Care Worker Patient Transmission; Aging
Study type: Interventional

Summary: 
      The purpose of this research study is to look at high dose zinc versus multivitamin
      micronutrient supplementation to support immune health in the setting of the COVID-19
      pandemic.
    

Detailed description: 
      This is a two-cohort prospective randomized study intended to test the role of Zinc versus
      multivitamin supplementation in supporting immune health in the setting of the COVID-19
      pandemic. Individuals over 50 years old or primary health care professionals over the age of
      18 who have had no evidence of prior COVID-19 infection and who have been asymptomatic for 7
      days prior to enrollment will be randomized at the individual level to take either
      PreserVision AREDS formulation soft gels or tablets with 69.6mg/day Zinc supplementation or
      to receive a multivitamin supplement with 11mg of zinc/day.
    

Intervention name(s): PreserVision AREDS formulation soft gels or tablets; Multivitamin with 11mg of zinc
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Two tabs taken daily for three months; One tab taken daily for three months
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Zinc; Immune health
Sodium Channel Expression in Human Teeth
Condition: Dental Pulp Disease
MeSH terms: Dental Pulp Diseases
Study type: Observational

Summary: 
      The human tooth pulp has many nerve fibers and is a common source of pain. This study
      examines nerve fibers within normal and painful samples and identifies changes that can
      contribute to the generation of pain.
    

Detailed description: 
      The human tooth pulp is a rich source of pain fibers and is a common site of pathology that
      is often accompanied by spontaneous and stimulus-induced lingering pain. A common treatment
      modality includes the extraction of the offending tooth diagnosed with irreversible pulpitis.
      Extracted teeth represent an abundant source of normal and diseased human nociceptors and the
      evaluation of these tissues represents a powerful model to study human pain mechanisms since
      the character of pain, pain levels, and response to stimuli can be documented prior to
      extraction.

      The overall objective of this study is to correlate changes in the expression of Sodium
      Channels (NaCh) with clinical responses to hot and cold thermal stimuli, and the expression
      of the associated receptors/transducers responsible for receiving that stimulus in extracted
      teeth with severe and spontaneous pain. Teeth requiring extraction in the clinical setting
      will be used for this study.

      The research questions are: 1.) To evaluate quantitatively the overall NaCh and Nav 1.3, 1.6,
      1.7, 1.8 1.9 isoform expressions in nerves of normal teeth as compared to diseased teeth 2.)
      To evaluate quantitatively hot/cold VR1 and CMR1 receptor expression in nerves of normal
      teeth as compared to the nerves in the modality-specific pain groups of diseased teeth 3.) To
      investigate the ultrastructural localization of NaCh isoforms in different fiber types and at
      sites that may be involved in pain generation.
    

Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Healthy patients presenting to the dental clinic with an indication for extraction of their
        normal third molar(wisdom) teeth or diseased teeth that are associated with pain.
      
Biospecimen description: 
      Extracted teeth including pulpal tissue
    
Keywords: Pain, Sodium Channel, Dental pulp
Patient Satisfaction With Postoperative Follow up After Minimally Invasive Hysterectomy
Condition: Minimally Invasive Surgery; Hysterectomy; Postoperative; Satisfaction
Study type: Interventional

Summary: 
      This prospective, randomized control trial will evaluate patient satisfaction with the number
      of postoperative follow up visits after minimally invasive hysterectomy for the treatment of
      non-cancerous conditions at an urban academic hospital in Louisville, Kentucky. Patients will
      be randomized to receive either a two and six week postoperative follow up visits versus a
      postoperative follow up visit at six weeks alone.
    

Detailed description: 
      The objective of follow up appointments following benign gynecologic surgery is to ensure
      adequate postoperative recovery, assess additional patient concerns, and to identify and
      manage any delayed postoperative complications. There is limited literature addressing
      short-term postoperative follow up for benign gynecologic surgery, particularly those
      performed through a minimally invasive approach.

      The benefits of minimally invasive surgery includes shorter operative time, reduced hospital
      stay, improved cosmesis, and faster recovery especially when combined with enhanced recovery
      after surgery (ERAS) protocols. However, this does not negate the need for follow up.
      Although no consensus exists on the appropriate frequency and number of postoperative
      appointments, there is no debate on its value.

      Due to lack of evidence on this issue, the number and frequency of postoperative appointments
      is currently dependent on surgeon preference, type of procedure performed and complications
      encountered intraoperatively and postoperatively, which could lead to patient confusion and
      unnecessary cost and hassle.

      For this reason, investigation of outcomes based on the number and frequency of postoperative
      follow up visits may improve optimal patient satisfaction, improve compliance and provide
      early detection of postoperative complications. Such knowledge could serve to mitigate
      efforts to develop and implement protocols to improve compliance with postoperative follow-up
      care, potentially reduce emergency room visits, readmissions, empower patients and reduce
      cost.
    

Intervention name(s): postoperative follow up appointment
Intervention type(s): Other
Intervention description(s): Comparison of two and six week postoperative follow up versus a six week postoperative follow up alone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: hysterectomy; minimally invasive surgery; gynecology; satisfaction
The Safety of Intravenous Lacosamide
Condition: Epilepsy
MeSH terms: Epilepsy
Study type: Interventional
Phase: Phase 4

Summary: 
      To evaluate the safety of IV Lacosamide in children with partial-onset epilepsy, ages 4-35
      years old, inclusive, who are either unable to take oral medication or require intravenous
      administration of IV Lacosamide.
    

Detailed description: 
      Lacosamide tablets and intravenous formulations were both approved in the United States in
      the fall of 2008. Lacosamide is indicated for use as adjunctive therapy in the treatment of
      partial onset seizure disorder in patients' age seventeen years and older. A parenteral
      dosage form of Lacosamide is desirable for patients who are temporarily unable to take
      medication orally. The objective of this study is to evaluate the safety of IV Lacosamide in
      children with epilepsy, ages 4 to 35 years, who are either unable to take oral medication, or
      whom parenteral administration of IV Lacosamide is desirable.
    

Intervention name(s): Lacosamide
Intervention type(s): Drug
Intervention description(s): 0.7 mg/kg (up to maximum of 50 mg) x 5 subjects x 30 minutes; 1.4 mg/kg (up to a maximum of 100 mg) x 5 subjects x 30 minutes; 2.1 mg/kg (up to a maximum of 150 mg) x 5 subjects x 30 minutes; 2.9 mg/kg (up to a maximum of 200 mg) x 5 subjects x 30 minutes.
0.7 mg/kg (up to a maximum of 50 mg) x 5 subjects x 15 minutes; 1.4 mg/kg (up to a maximum of 100 mg) x 5 subjects x 15 minutes; 2.1 mg/kg (up to a maximum of 150 mg) x 5 subjects x 15 minutes; 2.9 mg/kg (up to a maximum of 200 mg) x 5 subjects x 15 minutes
Other intervention name(s): Vimpat
Intervention MeSH terms: Lacosamide
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: partial; onset; epilepsy; pediatric; lacosamide; partial onset epilepsy; vimpat
Growth Retardation In Children With Special Pathological Conditions Or Disease
Condition: Endocrine System Diseases
MeSH terms: Endocrine System Diseases
Study type: Interventional
Phase: Phase 3

Summary: 
      To show an increase in annual growth rate 3 years after Visit 2. Annual growth rate in
      standard deviation (SD) after 3 years will be compared to growth rate before the start of GH
      treatment.
    


Intervention name(s): Somatropin
Intervention type(s): Drug
Intervention description(s): Adapted dosage based on IGF 1 level and weight Form: liquid; Dosage and Frequency: from 0.0033mg/kg/day to 0.0067 mg/kg/day; Duration: 3 years
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Punch Trabeculectomy Versus Classic Trabeculectomy
Condition: Glaucoma, Open-Angle
MeSH terms: Glaucoma, Open-Angle
Study type: Interventional

Summary: 
      Bleb failure is reduced with Punch trabeculectomy procedure. Wide sclerostomy during surgery
      is wanted but controllable. This can be done with single securing suture, releasable sutures
      and topical intraoperative mitomycin-c. Average IOP without fluctuation (risk factor) can
      protect the optic nerve.
    

Detailed description: 
      This is a prospective randomized study. Patients had uncontrolled glaucoma on maximum
      tolerated medical therapy including acetazolamide tablets were enrolled in this clinical
      trial and were randomized to tight flap technique group (group A) and loose flap technique
      group(group B). Randomization assigned 40 patients to group A and 40 patients to do group B.
      A total of 80 patients were enrolled in the Study between 2012 and 2014.

      During trabeculectomy, Trabecular meshwork and scleral lamellae were excised made an opening
      with the kelly scleral punch 1.0 mm 3-5 bites. At 12 o'clock 10/0 nylon monofilament stitch
      was used to close the apex of triangular scleral flap tightly and two releasable stitches
      were used at the sides of triangular scleral flap in group A. Fig-1 At 12 o'clock 10/0 nylon
      monofilament stitch was used to secure the edges of the flap at the apex of and two-four
      releasable stitches were used at the sides of triangular scleral flap in group B. The
      intraocular pressure and bleb morphology were followed for one year after surgery.
    

Intervention name(s): releasable sutures in punch trabeculectomy
Intervention type(s): Procedure
Intervention description(s): punch trabeculectomy,scleral flap suturing
Other intervention name(s): loose flap technique versus tight flap technique in punch trabeculectomy
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Eighty Patients inclusive, randomly distributed for tight flap technique group (forty patients-group A) and for loose flap technique (securing sutures) group (forty patients-group B).
Masking: Single (Participant)
Primary purpose: Treatment