bioihbjkbjnl/mcl2 huggingface dataset:
Local Infiltration Analgesia Following Unicompartmental Knee Arthroplasty
Condition: Postoperative Pain
MeSH terms: Pain, Postoperative
Study type: Interventional

Summary: 
      The primary aim of this study is to evaluate if intra- and postoperative administration of
      ropivacaine, ketorolac and epinephrine into the operating field would affect hospital stay.
      Secondary end-points are morphine consumption, pain intensity and side effects. In an attempt
      to assess the safety of this technique, knee function and patient satisfaction scores are
      assessed up to 6 months after surgery.
    

Detailed description: 
      Postoperative pain is often severe following knee arthroplasty. Recently, a local
      infiltration analgesia (LIA) technique was developed by Drs Kerr and Kohan in Sydney,
      Australia. With this LIA-technique, a long-acting local anesthetic (ropivacaine), a
      nonsteroidal anti-inflammatory drug (ketorolac), and epinephrine are infiltrated
      intraoperatively and via an intraarticular catheter postoperatively.

      The primary aim of this study is to evaluate if intra- and postoperative administration of
      ropivacaine, ketorolac and epinephrine into the operating field would affect hospital stay.
      Secondary end-points were morphine consumption, pain intensity and side effects. In an
      attempt to assess the safety of this technique, knee function and patient satisfaction scores
      were assessed up to 6 months after surgery.
    

Intervention name(s): ropivacaine, ketorelac and epinephrine; saline
Intervention type(s): Drug; Drug
Intervention description(s): In Group A, 200 mg ropivicaine, 30 mg ketorelac and 0.5 mg epinephrine (total volume 106 ml) are infiltrated by the surgeon into the soft tissues peri-articularly during the operation in the following way: Before inserting the components, 20-30 ml are injected into the posterior capsule and before closure of the wound the rest is injected into the capsule incision, the synovium, the ligament and the subcutaneous tissue After 21 postoperative hours in Group A, 150 mg ropivicaine, 30 mg ketorelac and 0.1 mg epinephrine, total volume 22 ml, are injected intraarticularly via the catheter.; In Group P (placebo) no injections were given intaoperatively. All patients had a tunnelled intra-articular multihole 20-G catheter placed at the end of the operation by the surgeon.After 21 postoperative hours 22 ml of saline was injected intraarticularly via the catheter.
Intervention MeSH terms: Epinephrine; Ropivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Postoperative pain; Local infiltration analgesia; Knee arthroplasty; Postoperative pain management following unicompartmental knee arthroplasty
Egg Freezing Pilot Study
Condition: Infertility; Egg Freezing
MeSH terms: Infertility
Study type: Interventional

Summary: 
      University Reproductive Associates is conducting a pilot study to study the technique of egg
      freezing. Your participation in this study will provide us with important information to
      allow us to offer this technology for women wishing to freeze their eggs before cancer
      treatments. Your participation will include a standard IVF cycle with your eggs being frozen
      for a brief period of time and then transferred back to you as usual. You will receive a
      significant reduction in your IVF cycle cost.
    


Intervention name(s): Oocyte Vitrification
Intervention type(s): Procedure
Intervention description(s): All oocytes retrieved will be vitrified (rapidly frozen) after egg retrieval. The oocytes will then be warmed on the same day and fertilized per standard IVF-ICSI. Resulting embryos will be transferred back to the patient as per protocol.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: infertility; egg freezing; fertility preservation
Bioequivalence of Ketoprofen Oral Gel vs Ketoprofen Lysine Salt as Granules for Oral Solution
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a single dose, open-label, randomised, two period, two-way cross-over, two stage
      bioequivalenve study with the aim to investigate the bioequivalence between a new formulation
      of ketoprofen 25 mg versus OKI 80 mg granules for oral solution (half sachet), after single
      dose administration in two consecutive periods to healthy voluteers under fed conditions.
    

Detailed description: 
      The present bioequivalence phase I study has been designed to compare the bioavailability and
      the concentration-time profile of the new immediate release oral gel formulation of
      ketoprofen 25 mg with a marketed reference of ketoprofen lysine salt (KLS) as granules for
      oral solution (80 mg bipartite sachet, half sachet containing 40 mg of KLS, corresponding to
      25 mg as ketoprofen), when administered in fed conditions to healthy male and female
      subjects. The study has been designed under fed conditions since the leaflet of the
      reference.

      A two-stage design has been selected for the present study considering the margin of
      uncertainty existing over the sample size estimate in order to accomplish the primary study
      objectives in terms of ketoprofen rate (Cmax) and extent (AUC0-t) of absorption of the two
      formulations.
    

Intervention name(s): Ketoprofen Lysine; Ketoprofen Oral Product
Intervention type(s): Drug; Drug
Intervention description(s): A single oral dose of test product - ketoprofen 25 mg/5 ml oral gel stick pack - will be administered to healthy male and female volunteers under fed conditions in two consecutive study periods with a wash-out interval of at least 7 days between the two administrations.; A single oral dose of reference product as a single dose of half of a bipartite sachet of OKi® 80 mg granules for oral solution will be administered to healthy male and female volunteers under fed conditions in two consecutive study periods with a wash-out interval of at least 7 days between the two administrations.
Other intervention name(s): OKI 80 mg
Intervention MeSH terms: Ketoprofen; Ketoprofen lysine
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Single dose, open-label, randomised, two-period, two-way cross-over, two-stage bioequivalence study.
Masking: None (Open Label)
Primary purpose: Other
Keywords: ketoprofen; oral gel; ketoprofen Lysine Salt as granules; bioequivalence
Joint Outcome Study Continuation for Children With Severe Factor VIII Deficiency
Condition: Hemophilia
MeSH terms: Hemophilia A
Study type: Observational

Summary: 
      The original Joint Outcome Study (JOS) enrolled 65 boys with hemophilia from 16 sites
      nationally. The subjects were randomized to one of two arms (prophylaxis or an enhanced
      episode-based treatment)and were followed prospectively until the age of six. At the age of
      six, the proportion of children on each treatment arm who developed bone or cartilage damage
      as determined by X-Ray or MRI was assessed. In addition, the function and structure of the
      index joints (defined as knees, ankles, and elbows)were evaluated using a physical assessment
      scale specially designed for preschool children.

      The specific aim of the Joint Outcome Study Continuation (JOSC) is to extend observations of
      the children participating in the original JOS until the subjects reach the age of 18 years
      in order to determine the natural history of joint development in hemophilia and the impact
      of primary or secondary prophylaxis on the prevention, limitation, or reversal of hemophilic
      arthropathy. In addition, plasma and DNA will be collected and banked yearly for current and
      future studies of biomarkers and predictors of hemophilia outcomes.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Study population will be invited based on their enrollment in the original Joint Outcome
        Study (JOS). This population
      
Biospecimen description: 
      Whole Blood - EDTA, Citrate Plasma, and DNA
    
Keywords: Hemophilia; Joint; Cartilage; Damage; Prophylaxis; Factor VIII; FVIII; Disease; Arthropathy
A Study of Baricitinib and Ciclosporin in Healthy Participants
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine the effects of ciclosporin on the amount of
      baricitinib that is absorbed into the blood stream and the time it takes to remove
      baricitinib from the body. The study will also look at how well-tolerated and safe
      baricitinib is, when given alone and in combination with ciclosporin. Side effects will be
      documented. The study will last approximately 6 days from the first dose to the end of the
      study (not including screening or follow-up).
    


Intervention name(s): Baricitinib; Ciclosporin
Intervention type(s): Drug; Drug
Intervention description(s): Administered orally; Administered orally
Other intervention name(s): LY3009104
Intervention MeSH terms: Cyclosporine; Cyclosporins
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
A Randomized, Blinded, Multicenter Study to Evaluate NASHA/Dx for the Treatment of Fecal Incontinence
Condition: Fecal Incontinence
MeSH terms: Fecal Incontinence
Study type: Interventional

Summary: 
      The purpose of this study is to determine the effectiveness and safety of NASHA/Dx when used
      as an injectable bulking agent in the treatment of fecal incontinence. The study includes a
      6-month blinded sham-controlled phase, followed by an open-label phase.
    

Detailed description: 
      Subjects will be given up to 2 treatments of NASHA/Dx or sham and followed for 6 months from
      last treatment (ie, one retreatment is permitted at 1 month after the first injection) in the
      blinded phase of the study. At Month 6, the open phase of the study will begin and subjects
      on sham will be offered open-label treatment with NASHA/Dx.

      Subjects who receive NASHA/Dx at the start of the blinded phase will be followed for up to 36
      months from last treatment in the blinded phase. Subjects who receive sham at the start of
      the blinded phase and then receive open-label NASHA/Dx at Month 6 (start of the open phase)
      will be followed for another 24 months (equivalent to approximately 30 months from
      randomization) from last treatment in the open phase of the study.
    

Intervention name(s): NASHA/Dx (Solesta) Gel; Sham Injection
Intervention type(s): Device; Device
Intervention description(s): Injection of 4 x 1ml of NASHA/Dx Gel at the start of the blinded phase.; Sham injection at the start of the blinded phase.
Other intervention name(s): Solesta
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Assessment of a Modified Minimally Invasive Esophagectomy
Condition: Esophageal Cancer
Study type: Observational

Summary: 
      This is a retrospective case series of a novel fully minimally invasive esophagectomy
      procedure for patients with primary esophageal cancer.
    


Intervention name(s): Fully minimally invasive esophagectomy
Intervention type(s): Procedure
Intervention description(s): Esophagectomy using a novel fully minimally invasive approach
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Consecutive sample of all patients undergoing the novel minimally invasive esophagectomy
        procedure at the Kaiser Permanente Northern California Oakland Medical Center during the
        study period
The Effects of Acupuncture on the Natural Pregnancy in Patients With Recurrent Abortion
Condition: Acupuncture; Recurrent Spontaneous Abortion; Ultrasound Therapy; Coagulation
MeSH terms: Abortion, Spontaneous; Abortion, Habitual; Recurrence
Study type: Interventional

Summary: 
      Recurrent spontaneous abortion (RSA) is a common pregnancy complication in women of
      reproductive age and the cause of RSA remains largely unclear. Acupuncture is widely used in
      clinical practice to treat infertility and abortion. The role of acupuncture in the treatment
      of infertility is still unclear. The investigators conducted a randomized, prospective,
      controlled clinical trial to investigate its potential impact on pregnancy outcome. Herein,
      the investigators not only evaluated the changes in patients' psychological stress before and
      after treatment but also followed up on pregnancy outcomes. In addition, changes in uterine
      artery blood flow were observed by ultrasound. Changes in coagulation-related indicators were
      also detected.
    

Detailed description: 
      To better illustrate the effectiveness and mechanism of acupuncture in infertility,
      especially in RSA patients, the investigators conducted a randomized, prospective, controlled
      clinical trial to investigate its potential impact on pregnancy outcome. Herein, the
      investigators not only evaluated the changes in patients' psychological stress before and
      after treatment but also followed up on pregnancy outcomes. In addition, changes in uterine
      artery blood flow were observed by ultrasound. Changes in coagulation-related indicators were
      also detected. The investigators hypothesized that acupuncture could promote and improve
      pregnancy by improving uterine artery blood flow and relieving patients' anxiety symptoms. To
      our knowledge, it has never been reported before.
    

Intervention name(s): acupuncture; routine aspirin and heparin treatment
Intervention type(s): Procedure; Drug
Intervention description(s): The patients in the acupuncture group accepted acupuncture treatment weekly from the second day of menstruation and three times in one cycle. Seirin 0.2-×30-mm acupuncture needles were used. First, needles were inserted into Shenting (GV 24) and bilateral Benshen (G 13) to relieve uneasiness of mind. Then, they were inserted into Chung wan (cv 12), Qihai (CV6), Guan yuan, chung chi (cv 3), bilateral Guiai (S 29) and Zigong (Extra 16) to recuperate energy. Finally, bilateral Tsusanli (st 36), Yinlingch'uan (sp 9) and San yin chiao (sp 6) were used to soothe the liver and tonify the spleen and kidney. Each acupuncture treatment session lasted 30 minutes, with mostly bilateral needle retention over 20-30 minutes for evens techniques.; The patients accepted routine aspirin and heparin treatment. Two months before pregnancy, 50 mg of aspirin (Chenxin Pharmaceutical, China) was taken orally once a day.
Intervention MeSH terms: Aspirin; Heparin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment
Clinical Trial of Efficacy and Safety of Anaferon for Children Liquid Dosage Form in the Treatment of Acute Upper Respiratory Infections
Condition: Acute Upper Respiratory Infections
MeSH terms: Infections; Communicable Diseases; Respiratory Tract Infections
Study type: Interventional
Phase: Phase 3

Summary: 
      Purpose of the study:

        -  To assess efficacy of Anaferon for children liquid dosage form in the treatment of acute
           upper respiratory tract infections.

        -  To assess safety of Anaferon for children liquid dosage form in the treatment of acute
           upper respiratory tract infections.
    


Intervention name(s): Anaferon for children (liquid dosage form); Placebo (liquid dosage form)
Intervention type(s): Drug; Drug
Intervention description(s): 10 drops per dose. Day 1: 10 drops every 30 minutes for the first 2 hours, followed by three more doses regularly spaced during the rest of the day. Day 2 to 5: 10 drops three times daily.; 10 drops per dose. Day 1: 10 drops every 30 minutes for the first 2 hours, followed by three more doses regularly spaced during the rest of the day. Day 2 to 5: 10 drops three times daily.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Effects of a Pre-school-based Nutritional Intervention on Children's Eating Behavior and Anthropometric Parameters
Condition: Obesity
Study type: Interventional

Summary: 
      This study assesses the impact of a nutritional intervention aimed at reducing childhood
      overweight in German preschoolers.
    

Detailed description: 
      Objective: To assess the impact of a nutritional intervention aimed at reducing childhood
      overweight in German preschoolers.

      Design: Using a cluster-randomized study design with waiting-list controls, we test a
      six-month intervention administered once weekly by a nutritional expert consisting of joint
      meal preparation and activities for children and parents like tasting and preparing
      nutritious, fresh foods. At baseline, six and twelve months, a parent-completed questionnaire
      assesses fruit and vegetable intake (primary outcomes) and water and sugared drink
      consumption (other outcomes). Direct measurement assessed BMI, percentage body fat (skin fold
      thicknesses) and waist-to-height-ratio. An intention-to-treat analysis used random effects
      panel regression models to assess the intervention effect, adjusted for each child's age,
      gender, immigrant background and maternal education.

      Setting: 18 Preschools from three south German regions. Subjects: Healthy children from three
      to seven years of age.
    

Intervention name(s): preschool-based nutritional intervention
Intervention type(s): Behavioral
Intervention description(s): 6-month intervention administered once weekly by a nutrition expert consisting of joint meal preparation and activities for children and parents such as tasting and preparing nutritious, fresh foods.
Other intervention name(s): Nutritional Module of program "Komm mit in das gesunde Boot"
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Latino Study - A Study of PEGASYS (Peginterferon Alfa-2a (40KD)) and COPEGUS (Ribavirin) in Treatment-Naive Patients With Chronic Hepatitis C-Genotype 1.
Condition: Hepatitis C, Chronic
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis; Hepatitis, Chronic
Study type: Interventional
Phase: Phase 4

Summary: 
      This single arm study will evaluate the efficacy and safety of PEGASYS (180 micrograms sc
      weekly) plus ribavirin (1000-1200mg po daily) in treatment-naive Latino patients versus
      non-Latino Caucasian patients with chronic hepatitis C- genotype 1. The anticipated time on
      study treatment is 3-12 months and the target sample size is 500+ patients.
    


Intervention name(s): Ribavirin; Peginterferon alfa-2a; Ribavirin; Peginterferon alfa-2a
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): 1000-1200mg po daily for 48 weeks; 180 micrograms sc/week for 48 weeks; 1000-1200mg po daily for 48 weeks; 180 micrograms sc/week for 48 weeks
Intervention MeSH terms: Ribavirin; Peginterferon alfa-2a; Interferon-alpha
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Effect of a Stress Reduction and Lifestyle Modification Programme on the Quality of Life of Crohn's Disease Patients
Condition: Crohn Disease
MeSH terms: Crohn Disease
Study type: Interventional

Summary: 
      Patients with crohn's disease often suffer significant limitations to their quality of life,
      which are also conditioned by particular stress and psychosocial accompanying symptoms of the
      disease. A multimodal program for stress-reduction and lifestyle-modification has been shown
      to be effective in promoting the quality of life in patients with uncreative colitis. The
      study will examine the promotion of the quality of life of patients with crohn's disease and
      the positive Influence on stress, psychological symptoms and physiological parameters.
    

Detailed description: 
      40 patients with ulcerative colitis will be randomized in an Intervention group and a control
      group for 10 weeks. The primary outcome is the feasibility of the study, the intervention and
      the examinations. The Secondary outcomes are disease-specific quality of life,
      disease-activity, stress, psychological symptoms, inflammatory parameters, disease activity
      parameters, bowel parameter and the microbiome. As qualitative parameters, the influence of
      the disease on everyday life and the experience/ impact/ implementability of the programme
      will be investigated. Lastly, undesirable events will be recorded.
    

Intervention name(s): lifestyle-modification; waiting control group
Intervention type(s): Behavioral; Behavioral
Intervention description(s): The group intervention is carried out once a week for 10 weeks for a total of 60 hours with elements of mindfulness-based stress reduction (MBSR) and further process of the mind / body medicine. In this project, this program will be adapted to the specific needs of crohn's disease patients.; Participants in this group receive a one-time education unit within the scope of 3 hours on the influence of lifestyle factors on the disease, also self-help materials for independent training offered. Following the follow-up measure also this group is given the opportunity to participate in the multimodal stress reduction- and lifestyle modification program.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Waiting Control Group Design
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Drug-eluting PTA Balloon Dilatation Catheter in the Treatment of Peripheral Artery Stenosis or Occlusion
Condition: Peripheral Arterial Disease; Iliac Artery Stenosis; Femoral Artery Stenosis; Popliteal Artery Stenosis; Iliac Artery Occlusion; Femoral Artery Occlusion; Popliteal Artery Occlusion
MeSH terms: Peripheral Arterial Disease; Peripheral Vascular Diseases; Arterial Occlusive Diseases; Constriction, Pathologic; Dilatation, Pathologic
Study type: Interventional

Summary: 
      Clinical study on safety and efficacy of ZENFlow™ drug-eluting PTA balloon dilatation
      catheter in the treatment of iliac, femoral and popliteal artery stenosis or occlusion
    

Detailed description: 
      The purpose of this study was to evaluate the safety and efficacy of ZENFlow™ drug-eluting
      PTA balloon dilatation catheter (paclitaxel 3±1 μg/mm2 balloon surface area) in the treatment
      of iliac artery, femoral artery and popliteal stenosis or occlusive lesions compared with
      conventional PTA balloon dilatation catheter.
    

Intervention name(s): ZENFlow™ Drug-eluting PTA Balloon Dilatation Catheter; Peripheral Balloon Dilatation Catheter
Intervention type(s): Device; Device
Intervention description(s): Digital subtraction angiography（DSA）; Digital subtraction angiography（DSA）
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Peripheral Arterial Disease; Drug-eluting PTA Balloon Dilatation Catheter; Late Lumen Loss（6 months）