bioihbjkbjnl/mcl2 huggingface dataset:
Reliability and Validity Study of Urdu Version of Oxford Knee Score in Patients With Knee Osteoarthritis
Condition: Knee Osteoarthritis
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Observational

Summary: 
      -  To translate the Oxford knee score into Urdu language

        -  To evaluate the reliability and validity of Urdu Version of Oxford knee score for
           accessing pain and physical function in patients with knee osteoarthritis.

        -  To evaluate the correlation of Oxford knee score with Western Ontario McMaster
           universities osteoarthritis index and International Knee Documentation Committee
    

Detailed description: 
      The original English version of Oxford Knee Score will be translated and culturally adapted
      as per previous recommendation. In patients with knee osteoarthritis, Urdu Version of Oxford
      Knee Score will be distributed among 100 participants choose a convenience sampling technique
      based on pre-defined inclusion and exclusion criteria. To test reliability of inter/intra
      observer of ultimate final Urdu Version of Oxford Knee Score will be filled from patients on
      the equivalent day, by 2 different bystanders, and for inter observer valuation, with an
      interval of 30 minutes between the first and second application. Third assessment will be
      carried out after 7 days of the Observer -1, for intra-observer assessment. Data will be
      entered and analyzed Cronbach alpha value. Test-retest reliability will be assessed using an
      intra-class correlation coefficient. Urdu Version of Oxford Knee Score will be evaluated for
      content validity, construct validity, criterion validity and responsiveness.
    

Observational model: Ecologic or Community
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Patients with knee Osteoarthritis were included from Pakistan
      
Keywords: Oxford Knee Score; Urdu Version; Reliability; Validity; Knee Osteoarthritis
Atrificial Shrinkage of Blastocyst Before In Vitro Fertilization
Condition: Infertility
MeSH terms: Infertility
Study type: Interventional

Summary: 
      Vitrification is a modern cryopreservation technique based on sudden cooling of reproductive
      cells to a temperature of -196 ° C in seconds that produces glass-like solidification of a
      solution without crystallization, but by extreme elevation in viscosity during freezing
    

Detailed description: 
      Vitrification is a modern cryopreservation technique based on sudden cooling of reproductive
      cells to a temperature of -196 ° C in seconds that produces glass-like solidification of a
      solution without crystallization, but by extreme elevation in viscosity during freezing
      Unlike the slow freezing method, vitrification has better results in a complete elimination
      of ice crystal inside the cells as well as in the surrounding solution -Also, it has a
      significantly higher post-thawing survival rate in comparison to slow freezing method
    

Intervention name(s): ICSI with laser pulse; ICSI with micro needle technique
Intervention type(s): Device; Device
Intervention description(s): Using laser pulse before ICSI; Using micro needle technique before ICSI
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: effect of using LASER pulse versus micro-needle use in the artificial shrinkage of blastocysts .
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Supportive Care
Efficacy and Safety of Levamlodipine Besylate Compared to Amlodipine Maleate in Patients With Essential Hypertension
Condition: Essential Hypertension
MeSH terms: Hypertension; Essential Hypertension
Study type: Interventional
Phase: Phase 4

Summary: 
      This study is designed to compare the safety and efficacy of levamlodipine besylate (2.5mg or
      5mg) versus amlodipine maleate (5mg) in patients with mild to moderate essential
      hypertension.
    


Intervention name(s): Levamlodipine besylate; Amlodipine maleate
Intervention type(s): Drug; Drug
Intervention description(s): Once daily, 7AM - 10AM; Once daily, 7AM - 10AM
Intervention MeSH terms: Amlodipine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Essential Hypertension; Levamlodipine Besylate; Amlodipine Maleate
Children's Aid Societies: Differential Response and Wraparound Prevention Trial
Condition: Children
Study type: Observational

Summary: 
      The purpose of this study is to assess the cost-effectiveness of this Differential Wraparound
      model, in 5 Children's Aid Societies within Hamilton-Niagara Region, in preventing
      maltreatment cases from either becoming ongoing protection cases, or the children ending up
      in out-of-home of out-of community placements, as well as reducing the amount of time in
      Children's Aid Society care as compared to usual Children's Aid Society risk assessment and
      protection service alone.
    

Detailed description: 
      The number of children in child welfare care has increased from 10,000 in the early 1990s to
      over 18,000. Ontario spends over $1.1 billion a year on direct child welfare services, more
      than twice as much as spent in the late 1990s, with the majority of these resources spent on
      investigation instead of treatment. In response to this situation, Differential Response
      models, sometimes called alternative, multiple or integrated system responses, have been
      implemented in the US, Australia and Canada and are all at the beginning stages of systematic
      evaluation. These models will help prevent maltreatment cases from becoming ongoing
      protection cases, or the children ending up in out of home or community placements, and
      reduce the amount of time in Children's Aid Society care. This research will show the
      benefits and costs of a Differential Response approach to Children's Aid Society care,
      specifically in the Hamilton-Niagara Region
    

Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Clients of CAS going on to protective custody cases
      
Keywords: Children and Youth; Families; Differential Response
Improving the Informed Consent Process for Youth Undergoing Pediatric Endoscopy and Their Parents
Condition: Children
Study type: Interventional

Summary: 
      The investigators employed a randomized control study design to evaluate the efficacy of a
      video intervention augmenting informed consent discussions in improving parental and youth
      informed consent comprehension.
    

Detailed description: 
      IC = informed consent

      The investigators employed a randomized control study design to evaluate the efficacy of a
      video intervention augmenting IC discussions in improving parental and youth IC
      comprehension. Sample size was selected to detect a 30% improvement in comprehension scores
      in the intervention v. control group. The local Institutional Review Board approved the
      study. Informed consent and assent were obtained prior to all study procedures.
    

Intervention name(s): video
Intervention type(s): Behavioral
Intervention description(s): Short (2 minute 43 second), animated videos were designed addressing nature of the procedure, risks, benefits, and alternatives for upper and lower endoscopy respectively using PowToon (www.powtoon.com). Sixth grade language was used throughout the video. Videos were shown to youth and their parents on an iPad.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: endoscopy
Blinding and Previous Experiences of Dry Needling
Condition: Neck Pain
MeSH terms: Neck Pain
Study type: Interventional

Summary: 
      Dry needling (DN) is a treatment technique widely used in patients with various
      musculoskeletal health problems due to myofascial trigger points (MTrP). DN has shown to have
      positive effect on pain and function in patients with mechanical neck pain. These positive
      results are thought to be the consequence of specific neurophysiological and mechanical
      processes. Research has shown that DN induces 1) end plate inhibition, 2) reduction of
      inflammatory substances, 3) increase of blood flow and oxygen and 4) a reduction of
      nociceptive afferent activity. However, the exact working mechanisms underlying DN effects is
      still a topic of debate. This trial addresses one of the major methodological issues in
      needle testing,the effects of proper blinding. DN is a specific technique that is not easily
      be replaced by another comparable intervention. A sham needle with a blunt tip was created
      that simulates penetration into the skin without actually doing so. Research about a valid
      method for the control in needling studies is for this reason of particular relevance. A
      proper blinding technique is of importance to further the field of DN.
    

Detailed description: 
      The objectives of this study are to analysize short-term effects on pain intensity and
      pressure pain sensitivity according to previous experience (blinding) in subjects with
      mechanical neck pain receiving real or sham-DN and to determine the success in masking DN
      versus sham DN in patients with mechanical neck pain based on prior experience with this
      technique.
    

Intervention name(s): Dry needling; Placebo needle
Intervention type(s): Device; Device
Intervention description(s): Real dry needling will be conducted according to Hong description, fast-in and fast-out interventions. The intervention will be applied until a total of four local twitch responses will be elicited; Sham dry needling with be conducted with a sham needle (Steitberger's Park sham device (PSD). This needle has a blunt tip and retractable handle that created the illusion of a needle penetrating the skin. When this needle touches the skin, a pricking sensation will be created. However, when pressure will be increased, the shaft of the needle disappears into the handle creating a sensation on the patient.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Dry needling; Placebo; Myofascial pain syndrome; Blinding
Trial to Evaluate the Immune Response to OPV When Administered Concomitantly With CAIV-T to Healthy Children.
Condition: Influenza
Study type: Interventional
Phase: Phase 3

Summary: 
      Phase III trial to evaluate the immune response to oral poliovirus vaccine (OPV) when
      administered concomitantly with CAIV-T to healthy children.
    


Intervention name(s): CAIV-T
Intervention type(s): Biological
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double
Primary purpose: Prevention
Study in Patients With Primary Breast Diffuse Large B-cell Lymphoma
Condition: Large B Cell Diffuse Lymphoma
MeSH terms: Lymphoma; Lymphoma, B-Cell; Lymphoma, Large B-Cell, Diffuse; Lymphoma, Non-Hodgkin
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to clarify the impact of rituximab on clinical outcomes in
      patients with primary breast diffuse large B-cell lymphoma and also to investigate the role
      of prophylactic intrathecal chemotherapy using methotrexate for reducing central nervous
      system (CNS) recurrence.
    

Detailed description: 
      Primary breast diffuse large B-cell lymphoma (DLBCL) is a rare presentation of non-Hodgkin's
      lymphoma. A significant risk of contralateral breast involvement and a tendency for central
      nervous system (CNS) progression have been identified in previous studies. Optimal treatment
      strategies for primary breast DLBCL have remained undefined, although the combination of
      anthracycline-based chemotherapy and radiotherapy may be considered to be the best treatment
      option in these studies. However, despite the administration of aggressive treatment,
      prognosis is still poor, even in localized disease, with 5-year progression-free survival
      rates of approximately 50% to 65% in most series. Therefore, other therapeutic options must
      be explored.

      During the last decade, several studies have shown that rituximab plus CHOP or CHOP-like
      chemotherapy significantly improves clinical outcomes of patients with DLBCL. However, the
      relevance of rituximab in the management of this rare extranodal lymphoma has never been
      studied. Moreover, several studies have also suggested the possibility that prophylactic
      intrathecal chemotherapy might be effective in reducing CNS recurrence.

      Thus, this trial is designed to prospectively evaluate the treatment strategy, which
      addressed the safety and efficacy of a combined therapy that included R-CHOP21 and
      prophylactic intrathecal chemotherapy using methotrexate.
    

Intervention name(s): Rituximab; Prophylactic intrathecal chemotherapy
Intervention type(s): Drug; Procedure
Intervention description(s): R-CHOP21 consist of rituximab (375 mg/m2), cyclophosphamide (750 mg/m2), doxorubicin (50 mg/m2), and vincristine (1.4 mg/m2, a maximum of 2mg), administered intravenously on day 1 and 100 mg oral prednisone on days 1 through 5.; Prophylactic intrathecal chemotherapy using methotrexate (12mg total dose) will be performed
Intervention MeSH terms: Rituximab
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: primary breast diffuse large B cell lymphoma; rituximab; prophylactic intrathecal chemotherapy; CNS recurrence
Influence of BIIAL Following PPH on Dorsal Clitoral Artery Blood Flow and FSFI
Condition: Bilateral Iliac Artery Ligation; Postpartum Hemorrhage
MeSH terms: Postpartum Hemorrhage; Hemorrhage
Study type: Observational

Summary: 
      Dorsal clitoral artery Doppler examinations in women with bilateral internal iliac artery
      ligation due to postpartum hemorrhage (study group) and age-matched healthy puerperal women
      were performed regularly in the postoperative period, in order to evaluate possible effects
      of BIIAL on clitoral blood flow.
    

Detailed description: 
      Women who underwent bilateral internal iliac artery ligation due to postpartum hemorrhage in
      Gaziantep Cengiz Gokcek Maternity Hospital, Gaziantep Turkey and Near East University,
      Department of Obstetrics and Gynecology, Mersin, Turkey comprise the study group. The control
      group consists of age-matched healthy women who delivered in last 2 months.

      Dorsal clitoral artery Doppler examinations will be performed in both case and control groups
      regularly in the postoperative period in 3rd and 6th months, in order to evaluate the
      possible effects of BIIAL on clitoral blood flow. Ultrasound is performed using a Mindray
      DC-7 Ultrasound System (China) equipped with linear 7.5 MHz probe. Each woman was scanned in
      the gynecological position. The translabial probe is placed on the clitoris sagittally and
      transversely without applying any pressure force. After identifying the clitoral artery using
      colour flow mapping, the Doppler probe is positioned over the vessel and at least three
      sequential Doppler wave forms are obtained. The following parameters are analysed: peak
      systolic velocity (PSV), end diastolic velocity (EDV), resistive index (RI), pulsatile index
      (PI) and systolic/diastolic (S/D) ratio. The measurements are performed by the same
      radiologist.

      Finally a Female Sexual Fantasy Questionnaire (FSFQ) is performed.
    

Intervention name(s): Doppler ultrasonographic examination
Intervention type(s): Other
Intervention description(s): Dorsal clitoral artery Doppler ultrasonographic examinations will be performed regularly in 3rd and 6th months after delivery, in order to evaluate the possible effects of BIIAL on clitoral blood flow.
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        18-35 year old women with postpartum hemorrhage who did and did not undergo bilateral
        internal iliac artery ligation (BIIAL)
      
Keywords: Ultrasonography, Doppler, Color; Postpartum hemorrhage; Bilateral iliac artery ligation; Dorsal clitoral artery
Effects of a Cocoa Shot on the Human Brain 2
Condition: Caffeine
Study type: Interventional

Summary: 
      The Hershey Company is interested in investigating the effects of various chocolate beverages
      on brain physiology and cognitive function. The main substances in the drinks that are known
      to influence the brain are caffeine and related chemicals such as theobromine. Caffeine and
      chemicals related to caffeine are all naturally occurring and all potentially alter brain
      physiology. This study will evaluate changes in brain blood flow and cognition following the
      consumption of drinks with various combinations of the Primary Ingredients. The study
      proposed here will evaluate ingredients in a 4-arm cross-over double-blind design in an
      attempt to understand the differential effects of these compounds in chocolate drinks.
    


Intervention name(s): no caffeine; high caffeine; no theobromine; low theobromine; high theobromine
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention MeSH terms: Theobromine; Caffeine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: Caffeine; MRI; Brain blood flow; Cognition; Perfusion; Resting functional magnetic resonance imaging (fMRI)
Rotational Thromboelastography Study in Tranexamic Acid and Colloid Infusion
Condition: Avascular Necrosis of Femoral Head; Degenerative Arthritis of Hip
MeSH terms: Osteoarthritis; Necrosis
Study type: Interventional

Summary: 
      Colloid solution is generally used to maintain intravascular volume. It is reported to impair
      blood coagulation in vivo and in vitro more than crystalloid does by prolonging coagulation
      time and decreasing clot strength. The formed fibrin clot is more vulnerable for fibrinolysis
      in a case of using colloid. Dilution of plasmin in vitro with colloid enhances fibrinolysis
      primarily by diminishing α2-antiplasmin-plasmin interaction.

      Tranexamic acid is an antifibrinolytics that competitively inhibits the activation of
      plasminogen, by binding to specific site of both plasminogen and plasmin, a molecule
      responsible for the degradation of fibrin, a protein that forms the framework of blood clot.
      It is used to treat or prevent excessive blood loss during surgery and in other medical
      conditions. Gastrointestinal effect, dizziness, fatigue, headache, hypersensitivity reaction,
      or potential risk of thrombosis is reported as the adverse effect of tranexamic acid.

      We hypothesized that inhibition of plasmin by tranexamic acid after colloid administration
      can improve the colloid-induced clot strength impairment.
    


Intervention name(s): Tranexamic Acid
Intervention type(s): Drug
Intervention MeSH terms: Tranexamic Acid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Clinical Study on the Effect of Elevit Pregnancy 2nd & 3rd Trimester (Multi-micronutrients & DHA Supplement) on the Nutritional Status of Pregnant Women During Second and Third Trimester
Condition: Healthy Pregnant Women
Study type: Interventional

Summary: 
      The aim of this study is to collect information how adding a soft gel preparation of
      micronutrients such as vitamins, dietary minerals plus omega-3 fatty acid (docosahexaenoic
      acid, DHA) to the diet of pregnant women during the 2nd and 3rd trimesters of pregnancy
      effects the nutritional state of the mother and infants at delivery.
    


Intervention name(s): Elevit Pregnancy 2nd & 3rd Trimester; Non-Supplement
Intervention type(s): Dietary Supplement; Other
Intervention description(s): Once daily micronutrient plus DHA supplementation (Multi-micronutrients and docosahexaenoic acid (MMS) soft gel capsules); Control study group of pregnant women non-supplemented with multi-micronutrients and docosahexaenoic acid (MMS) soft gel capsules
Other intervention name(s): BAY 987765 Multi-micronutrient & DHA
Intervention MeSH terms: Micronutrients
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Supportive Care
Long Term Treatment Effect of the Safety, Tolerability and Efficacy of AAT in Type 1 Diabetes
Condition: Type 1 Diabetes; Beta Cell Preservation
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Phase 2

Summary: 
      At a previous study the investigators have assessed the safety and efficacy of treatment with
      AAT(Alpha 1 Antitrypsin)in newly diagnosed type 1 diabetes subjects aiming at beta cells
      preservation .

      Since treatment with AAT is expected to be a chronic treatment; stopping treatment will
      probably result in eventual loss of the preserved beta-cell function. Indeed, other
      investigational drugs aiming at beta cells preservation have shown that patients who were
      initially treated and maintained their initial beta-cell function, required continuation of
      treatment or they lost the beta-cell function.

      Therefore, in this extension study, patients who were previously treated with AAT and
      maintained clinically significant beta-cell function are offered a continuation of treatment,
      since they are likely to benefit from use of the medication.

      The proposed study is aimed to assess the long term effect of AAT in subjects with type 1
      diabetes mellitus: safety and tolerability of treatment, and effect on beta-cell function.

      Subjects who have completed all visits of the 008 study will be offered to participate in the
      extension study.

      The study will be consist off two main arms as following:

      Arm 1: Subjects who maintained peak stimulated C-peptide secretion ≥ 0.2 nmol/L will continue
      treatment with AAT for up to 18 treatments according to the dosage group they were allocated
      to in the 008 study.

      Arm 2:

      Subjects who have not maintained peak stimulated C-peptide secretion ≥ 0.2nmol/L and subjects
      with peak stimulated C -peptide secretion ≥ 0.2 nmol/L who are reluctant to receive
      additional study drug.

      Clinical follow up for all subjects in both arms will be for 3 years
    


Intervention name(s): AAT( Alpha 1 Antitrypsin)
Intervention type(s): Drug
Intervention MeSH terms: Alpha 1-Antitrypsin; Protein C Inhibitor
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Type 1 Diabetes; newly diagnosed; Beta cell preservation