bioihbjkbjnl/mcl2 huggingface dataset:
Local Infiltration Analgesia Following Total 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 morphine
      consumption. Secondary end-points are hospital stay, 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 3 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. We ahve completed a
      study on unicompartmental knee arthroplasty and the present study is investigating total knee
      arthroplasties.

      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 morphine
      consumption. Secondary end-points are hospital stay, 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 3 months after surgery.
    

Intervention name(s): ropivacaine, ketorolac and epinephrine; saline
Intervention type(s): Drug; Drug
Intervention description(s): In Group A, 400 mg ropivicaine, 30 mg ketorolac and 0.5 mg epinephrine (total volume 166 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, 200 mg ropivicaine, 30 mg ketorolac and 0.1 mg epinephrine, total volume 22 ml, are injected intraarticularly via the catheter.; In Group P (placebo) no injections were given intraoperatively. 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: Ketorolac; 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
EFFECT OF STRESS BALL ON COMFORT AND ANXIETY CONTROLLED TRIAL
Condition: Anxiety; Comfort
MeSH terms: Anxiety Disorders
Study type: Interventional

Summary: 
      In this study, it was aimed to determine the anxiety levels and comfort levels of the
      patients using stress ball in patients receiving hemodialysis treatment.

      This study was conducted as a randomized controlled trial. The universe of the study
      consisted of 156 patients receiving HD treatment at a special hemodialysis center. The study
      was completed with a total of 63 patients, including 31 people in the intervention group and
      32 people in the control group, who met the criteria for inclusion in the study between
      27.02.2023 and 27.03.2023.

      The individual demonstration form was used to collect data, the Visual Analog scale (VAS) for
      stress level and the hemodialysis comfort scale.
    

Detailed description: 
      Procedures administered to intervention groups:

      Patients will be given written and oral consent by explaining the purpose of the study.
      Patients with fistula and non-grafted arms will be asked to fill out data collection forms at
      the first interview. Patients will then be asked to squeeze the stress ball 15 minutes before
      the start of hemodialysis treatment and for 15 minutes during hemodialysis treatment. This
      treatment will be performed during the 9 (nine) hemodialysis treatment. After the last
      session, data collection forms will be filled out again.

      Use of stress Ball

      1) Place a stress ball in one hand (which hand will be left to the patients' wishes.)
      2.Squeeze the ball in your hand for 2-3 seconds after receiving it and then loosen it.

      3.Perform this application for a total of 30 minutes before and during hemodialysis
      treatment.

      Procedures administered to control groups:

      No intervention will be given to the control group other than standard treatment. Data
      collection forms will be completed before the first dialysis session and after the ninth
      session.
    

Intervention name(s): stress ball
Intervention type(s): Other
Intervention description(s): The use of the stress ball by the experimental group patients will be reminded by a hemodialysis nurse who was not involved in the study.
Allocation: Randomized
Intervention model: Single Group Assignment
Intervention model description: With this randomized controlled trial, it is aimed to determine the anxiety levels and comfort levels of the patients by using a total of 30 minutes of stress ball at the beginning and during 9 sessions of hemodialysis treatment in patients receiving hemodialysis treatment.
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: hemodialysis, comfort, anxiety
Multi-scale Modeling for Predictive Characterization of Ligaments and Grafts Behavior in ACL Reconstruction
Condition: Anterior Cruciate Ligament Reconstruction
Study type: Observational

Summary: 
      The objective of this clinical trial is provide in vivo data thus to model the ligament
      biomechanical behavior within the physiologically healthy joint and to use the implemented
      model to predict risk and success rates focusing on knee joint Anterior Cruciate Ligament
      (ACL) reconstruction. Current ACL surgery offers 3 alternatives: autografts, allografts and
      bioengineered grafts; the choice of the implant and its characteristics still remains a
      critical point. The knowledge of patient-specific joint and graft biomechanics is fundamental
      to reduce surgical revision rate and low functional outcome. This clinical trial will provide
      data coming from patient-specific biomechanics into a prognostic computational model, able to
      provide information on both the optimal customized reconstruction and graft status during the
      early rehabilitation phase. This patient-specific approach will lead to quicker return to
      sports activity, reducing also the possibility of early osteoarthritis.
    


Intervention name(s): Anterior Cruciate Ligament Reconstruction
Intervention type(s): Procedure
Intervention description(s): Reconstruction of the anterior cruciate ligament by means of the three reported techniques, namely single-bundle, single-bundle with extraarticular tenodesis and anatomic double-bundle.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients with primary lesion of the anterior cruciate ligament (ACL), assessed by clinical
        manouvers and confirmed by means of MRI.
      
Keywords: Anterior Cruciate Ligament; Reconstruction; Ligament modeling
Single Tablet Regimen (STR) Simplification Study for HIV-1 Infected Patients
Condition: HIV Infections
MeSH terms: HIV Infections
Study type: Interventional
Phase: Phase 4

Summary: 
      To compare the effectiveness (efficacy, safety & tolerability) of a Single Tablet Regimen of
      efavirenz/emtricitabine/tenofovir DF to subjects continuing on unmodified HAART as measured
      by the proportion of patients who maintain viral load (HIV-1 RNA) <200 copies/mL at Week 48.
    


Intervention name(s): Efavirenz (EFV), Emtricitabine (FTC), Tenofovir DF (TDF)
Intervention type(s): Drug
Intervention MeSH terms: Tenofovir; Emtricitabine; Efavirenz
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: HIV; HIV-1; AIDS; Human Immunodeficiency Virus; HIV-1 Infection
Performance of a Hearing Aid Platform Including Different Styles of Hearing Aids
Condition: Hearing Loss, Bilateral or Unilateral
MeSH terms: Hearing Loss; Hearing Loss, Bilateral
Study type: Interventional

Summary: 
      The reason for this study is to evaluate a new hearing aid product generation replacing the
      one on the market. The goal is to evaluate the audiological performance, usability as well as
      features and functions.
    

Detailed description: 
      This is a controlled, single blinded comparative study which is conducted monocentric at
      Phonak Headquarters in Staefa. The focus is to compare a new hearing aid product generation
      with the one on the market as well as with competitor devices regarding the audiological
      performance, usability as well as features and functions with the aid of 382 mild to profound
      hearing impaired subjects (18-90 yrs). The subjects, all of them native (Swiss) German
      speakers, individually conduct a number of laboratory standard tests and home trials
      (questionnaires) during nine weeks including weekly appointments of 2 hours.
    

Intervention name(s): Hearing aid.
Intervention type(s): Device
Intervention description(s): The hearing aid will be fitted to the individual hearing loss of the subject.
Intervention model: Single Group Assignment
Masking: Single (Participant)
Follicular Fluid Sialic Acid Levels in IVF Cycles
Condition: in Vitro Fertilization
Study type: Interventional

Summary: 
      This cross-sectional study was conducted at the Reproductive Endocrinology and Invitro
      Fertilization (REI) unit of our hospital, following the approval of the hospital's ethics
      committee. Patients who underwent gonadotropin-releasing hormone agonist (GnRHa) treatment
      were enrolled in the study. During oocyte retrieval, follicular fluids of mature follicles
      (≥18 mm) were collected and pooled for each patient. The thiobarbituric acid method was used
      for the sialic acid levels and the absorbance values were measured by a spectrophotometer at
      549 nm.
    

Detailed description: 
      This cross-sectional study was conducted at the Reproductive Endocrinology and Invitro
      Fertilization (REI) unit our hospital, following the approval of the hospital's ethics
      committee. The inclusion criteria were as follows; under 40 years of age, normal thyroid and
      prolactin hormone levels, a basal follicle stimulating hormone (FSH) level <10 mIU/mL, BMI of
      19-30 kg/m2. Exclusion criteria: a history of ovarian surgery, endometriosis, uterine
      anomaly, any endocrine disease including congenital adrenal hyperplasia, smokers, use of any
      medications and hormones in the last 3 months. Before the IVF treatment serum follicle
      stimulating hormone (FSH), luteinizing hormone (LH), prolactin (PRL), thyroid-stimulating
      hormone (TSH), and estradiol (E2) levels were measured on the third day of the cycle. Age,
      body mass index, duration of stimulation, duration of infertility, the total dose of
      gonadotropins, E2 on the day of hCG administration, number of oocytes retrieved,
      fertilization rate, and pregnancy rate were recorded.

      All patients underwent gonadotropin-releasing hormone agonist (GnRHa) treatment. Oocyte
      retrieval was done 36 hours after the hCG injection and ICSI was used for all patients.
      Embryo transfer was performed 48-72 hours after the oocyte retrieval.

      During oocyte retrieval, follicular fluids of mature follicles (≥18 mm) were collected from
      the first follicle entered and were aspirated for each patient. Follicle aspirates, which
      were not clear and contaminated with blood, were excluded. Total and free sialic acid levels
      were measured in the follicular fluid.
    

Intervention name(s): in vitro fertilization
Intervention type(s): Diagnostic Test
Intervention description(s): All patients underwent gonadotropin-releasing hormone agonist (GnRHa) treatment for in vitro fertilization and Follicular fluid sialic acid levels are measured.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: in vitro fertilization; sialic acid
Immunogenicity and Safety Study of Serum-Free Avonex
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis
Study type: Interventional
Phase: Phase 2

Summary: 
      To evaluate the immunogenicity of a serum-free pre-formulated solution of Avonex when given
      to interferon beta naive patients with relapsing/remitting multiple sclerosis.
    


Intervention name(s): Interferon beta-1a
Intervention type(s): Drug
Intervention description(s): serum free Avonex given IM once a week
Other intervention name(s): Avonex
Intervention MeSH terms: Interferons; Interferon-beta; Interferon beta-1a
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: multiple sclerosis; interferon beta-1a; avonex
Kinematics of Obese Patients Perambulation
Condition: Morbid Obesity; Surgical Management by Laparoscopic Sleeve Gastrectomy
MeSH terms: Obesity, Morbid
Study type: Interventional
Phase: Phase 3

Summary: 
      The aim of this study is to evaluate the consequences of sleeve gastrectomy on functional
      parameters of patients perambulation.
    

Detailed description: 
      Laparoscopic Sleeve gastrectomy is the standard surgical procedure for the treatment of obese
      patients. Even the surgery is well described, there is no available study about its influence
      on the functional parameters of patients perambulation.
    

Intervention name(s): 6-minute walk test
Intervention type(s): Procedure
Intervention description(s): the test corresponds to that defined by Abdel Kafi et al in 2005
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: obesity; surgery
High Oral Loading Dose of Cholecalciferol in Non-Alcoholic Fatty Liver Disease
Condition: Non-Alcoholic Fatty Liver Disease
MeSH terms: Liver Diseases; Fatty Liver; Non-alcoholic Fatty Liver Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      Non-alcoholic fatty liver disease (NAFLD) is a metabolic disorder with high prevalence in
      patients suffering from chronic liver diseases [1]. NAFLD is characterized by the
      accumulation of > 5% of fat deposits in hepatocytes (hepatic steatosis) with no known other
      reasons for steatosis as excessive alcohol intake.The global prevalence of NAFLD differs
      depending on the population reaching 13% in Africa, 32% in the Middle East, and 30 % in the
      United States
    


Intervention name(s): Cholecalciferol; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Vit D is a fat-soluble vitamin, provided by sunlight and activated by kidneys and liver.; matching placebo to Vit D
Intervention MeSH terms: Cholecalciferol; Vitamin D
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment
Effect of Water Rinsing After Topical Fluoride Application on Dental Plaque pH
Condition: Dental Caries
MeSH terms: Dental Caries; Dental Plaque
Study type: Interventional

Summary: 
      The aim of this study was to determine whether rinsing with water or cleansing teeth after
      topical fluoride therapy affect the dental plaque pH.
    


Intervention name(s): cleansing teeth after topical fluoride therapy
Intervention type(s): Procedure
Intervention description(s): washing with water 0, 15 or 30 min after APF treatment or cleansing teeth with cotton roll immediately following APF treatment.
Intervention MeSH terms: Fluorides; Fluorides, Topical
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: Acidogenicity; Acidulated phosphate fluoride; dental plaque; water rinsing
Study to Assess Adverse Events and the Movement of Oral Venetoclax Tablet Through the Body of Female Participants Aged 18-75 Years With Impaired Renal Function
Condition: Renal Impairment; Renal Disease
MeSH terms: Kidney Diseases; Renal Insufficiency
Study type: Interventional
Phase: Phase 1

Summary: 
      Renal insufficiency is common in participants with blood cancers. The main objective of this
      study is to evaluate adverse events and movement of oral venetoclax tablets through the body
      of female participants with severe normal renal function and those with end stage renal
      disease (ESRD) requiring hemodialysis.

      Venetoclax is an investigational drug being developed for the treatment of various
      hematologic malignancies. Study doctors put the participants in 1 of 2 groups, called
      treatment arms. Each group receives a different treatment. Approximately 12 female
      participants between 18 and 75 years, with Body Mass Index (BMI) between 18 to 42 kg/m2 will
      be enrolled in approximately 4 sites across the world.

      Participants with normal renal function will receive single dose of oral venetoclax tablet.
      Participants with ESRD will receive oral venetoclax tablets just prior to hemodialysis
      (Period 1 Day 1) and between dialysis days (Period 2 Day 1), doses in the two periods will be
      separated by at least 7 days.

      There may be higher treatment burden for participants in this trial compared to their
      standard of care. Participants will attend regular visits during the study at a hospital or
      clinic. The effect of the treatment will be checked by medical assessments, blood and urine
      tests, checking for side effects.
    


Intervention name(s): Venetoclax
Intervention type(s): Drug
Intervention description(s): Oral Tablet
Other intervention name(s): Venclexta; ABT-199; GDC-0199
Intervention MeSH terms: Venetoclax
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Renal Impairment; Renal Disease; End stage renal disease (ESRD); Venetoclax; Venclexta
Yoga on Arrhythmia Burden and Quality of Life in Paroxysmal Atrial Fibrillation
Condition: Atrial Fibrillation
MeSH terms: Atrial Fibrillation
Study type: Interventional

Summary: 
      Studies in the past have shown that yoga could relieve stress which is the most common
      trigger for recurrent episodes of atrial fibrillation. Breathing exercises in yoga are found
      to influence the autonomic nervous system (particularly parasympathetic) and thus reduce
      palpitations. This study hypothesizes that patients with atrial fibrillation might benefit by
      practicing yoga. Yoga may also help to better control heart rate and rhythm when used in
      combination with usual medical management.
    


Intervention name(s): Yoga training
Intervention type(s): Other
Intervention description(s): Yoga training for 12 weeks
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Keywords: atrial fibrillation, yoga
Recombinant Human C1 Inhibitor for the Treatment of Acute Attacks in Patients With Hereditary Angioedema
Condition: Genetic Disorders
MeSH terms: Angioedema; Angioedemas, Hereditary; Genetic Diseases, Inborn
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this single-center study is to explore the efficacy, safety, tolerability and
      pharmacokinetics/pharmacodynamics of recombinant human C1 inhibitor in the treatment of acute
      attacks in patients with hereditary angioedema.
    


Intervention name(s): i.v. recombinant human C1 inhibitor
Intervention type(s): Drug
Intervention MeSH terms: Complement C1 Inhibitor Protein
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Gall Bladder Bed Infiltration Analgesia
Condition: Pain, Acute
MeSH terms: Acute Pain
Study type: Interventional

Summary: 
      Early postoperative pain is a common complaint after elective laparoscopic cholecystectomy.
      Persistent acute postoperative pain is the dominating complaint and the primary reason for a
      prolonged stay after this procedure. This pain can be superficial incisional wound pain
      (somatic), deep visceral pain and/or post-laparoscopy shoulder pain (referred somatic), all
      of which may require systemic analgesia. Hypothesis: Laparoscopic pain can be superficial
      incisional wound pain (somatic pain), deep visceral pain and/or post-laparoscopy shoulder
      pain (referred somatic pain), so the block must be periportal for incisional wound pain,
      intraperitoneal to decrease pain caused by pneumoperitoneum, and of the bladder bed to
      decrease the deep visceral pain. This combination can give the maximum analgesia after
      laparoscopic cholecystectomy.
    

Detailed description: 
      Bladder bed irrigation with Bupivacaine was an effective method for reducing pain during the
      first postoperative hours after laparoscopic cholecystectomy. The intraperitoneal
      administration of lidocaine solution (total dose, 3.5 mg/kg) will be done as follows:
      immediately after creation of the pneumoperitoneum, the surgeon will spray 50-75 ml of the
      total solution on the upper surface of the liver under the right sub-diaphragmatic space, and
      another 50-75ml of the total solution under the left sub-diaphragmatic space. In order to
      allow the sprayed solution to diffuse under the diaphragmatic space, the Trendelenburg
      position will be maintained for 2 minutes.

      In the infiltration group will be administrating 5 ml lidocaine at each port site before
      incision, then the surgeon will spray 50-75 ml of the total solution on the upper surface of
      the liver under the right sub-diaphragmatic space, and another 50-75ml of the total solution
      under the left sub-diaphragmatic space then 50 ml will be infiltrated in the bladder bed
      after clamping of the cystic duct and cystic artery. CO2 will be humidified and wormed.
    

Intervention name(s): the infiltration group; the control group
Intervention type(s): Drug; Drug
Intervention description(s): 15-20 ml periportal,
50 ml in gallbladder bed,
The rest (about 150 ml in 70 Kg patient) will be intraperitoneal; the 50 ml prepared for gallbladder bed infiltration will be replaced by saline.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: cholecystectomy;; analgesia;; gallbladder;; infiltration;; visceral pain