bioihbjkbjnl/mcl2 huggingface dataset:
Arthroscopic Rotator Cuff Repair With Multimodal Analgesia(MMA)
Condition: Rotator Cuff Tear
MeSH terms: Rotator Cuff Injuries
Study type: Interventional

Summary: 
      -  The purpose of this study is to compare the efficacy of periarticular injections
           consisting of ropivacaine, morphine, epinephrine, cefotetan, and hyaluronic acid with
           the efficacy of periarticular injections consisting of the same amount of
           placebo(isotonic saline) during arthroscopic rotator cuff repair.

        -  Adding of multimodal analgesia(MMA) to conventional rotator cuff repair, it was expected
           that could reduce postoperative pain and narcotic consumption.
    


Intervention name(s): Arthroscopic rotator cuff repair with intraoperative periarticular injection; Arthroscopic rotator cuff repair with non-injection of MMA drugs
Intervention type(s): Procedure; Procedure
Intervention description(s): Under general anesthesia, the patient was placed in the lazy lateral decubitus position on the operating table.
The surgical area was prepared and draped with Betadine.
Small stab incisions were made in the creation of 4 or 5 portals as needed.
A scope was explored via the arthroscopic portal into the GH joint & subacromial space.
Repaired of rotator cuff tear was done with suture anchors.
Mixed MMA drugs(ropivacaine 300mg;40ml, morphine 10mg;1ml, cefotetan 1g; dilution to ropivacaine, epinephrine 0.3mg;0.3ml, total volume:41.3ml) and sodium hyaluronate 20mg;2ml were injected divisionally periarticular area; intra-articular(sodium hyaluronate 20ml;2ml + 10.3ml); posterior joint capsule(10ml); subacromial space and around suprascapular nerve(11ml); anterior capsule(10ml).
The skin was closed with Nylon or medical staples.
Sterile dressing was applied on surgical wound.
Peripheral intravenous PCA(Patient Controlled Analgesia) was connected.; Under general anesthesia, the patient was placed in the lazy lateral decubitus position on the operating table.
The surgical area was prepared and draped with Betadine.
Small stab incisions were made in the creation of 4 or 5 portals as needed.
A scope was explored via the arthroscopic portal into the GH joint & subacromial space.
Repaired of rotator cuff tear was done with suture anchors.
43.3ml of saline was injected divisionally periarticular area; intra-articular(12.3ml); posterior joint capsule(10ml); subacromial space and around suprascapular nerve(11ml); anterior capsule(10ml).
The skin was closed with Nylon or medical staples.
Sterile dressing was applied on surgical wound.
Peripheral intravenous PCA(Patient Controlled Analgesia) was connected.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Effect of Domperidone on Completion Rate of Vedio Capsule Endoscopy
Condition: Capsule Endoscopy; Pediatric Disorder
Study type: Interventional

Summary: 
      Video capsule endoscopy (VCE) has become an established technique to investigate the presence
      of small bowel pathology. But the limited battery life of capsules can lead to incomplete
      small bowel visualization. There is a rationale to use prokinetic agents prior to VCE reduce
      the chances of an incomplete small bowel examination via decrease gastric transit time (GTT).
      Investigators are aimed to prospectively compare the completion rate of VCE in pediatric
      patients receiving prokinetic with those receiving no prokinetic.
    

Detailed description: 
      Eligible children were randomly divided into two groups: domperidone prior to VCE and water
      prior to VCE. The primary outcome measure was the completion rate. Secondary outcome measures
      included the GTT and SBTT.
    

Intervention name(s): Domperidone; water
Intervention type(s): Drug; Dietary Supplement
Intervention description(s): 5ml Domperidone prior to VCE; 5ml water prior to VCE
Other intervention name(s): simethicone; simethicone
Intervention MeSH terms: Domperidone; Simethicone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Health Services Research
Keywords: domperidone
Comparing Exertional Heat Illness Risk Factors Between Patients and Controls
Condition: Exertional Heat Illness
MeSH terms: Heat Stress Disorders
Study type: Observational

Summary: 
      The arduous nature of military training and operations require personnel to encounter high
      heat load, e.g., during intense physical exertion, particularly in the heat. These conditions
      reduce operational effectiveness and expose personnel to a risk of incapacitation and death
      from exertional heat illness (EHI). The primary aim of this study is to compare putative
      'chronic' EHI risk factors between a cohort who have suffered a history of EHI and a control
      cohort with no EHI history. The secondary aim is to examine the influence of these EHI risk
      factors on thermoregulation during a standard heat tolerance assessment.
    

Detailed description: 
      Military training and operations present a risk of incapacitation and death from Exertional
      Heat Illness (EHI). However, widely accepted EHI risk factors are absent in almost half of
      all United Kingdom (UK) military EHI cases, indicating that a significant number of EHI cases
      in military personnel involve alternative risk factors. Risk factors for EHI can been
      classified along a spectrum ranging from acute (e.g. recent poor sleep) to chronic (e.g. low
      fitness), with the role of chronic risk factors supported by the observation that individuals
      who have suffered an EHI are at a substantially increased risk of subsequent EHI. The primary
      aim of this study is to compare putative 'chronic' EHI risk factors (e.g. composition of
      gastrointestinal (GI) microbiome, infection and inflammation, trait-like psychological
      factors) between a cohort who have suffered a history of EHI and a control cohort with no EHI
      history. The secondary aim is to examine the influence of these EHI risk factors on
      thermoregulation during a standard heat tolerance assessment.
    

Intervention name(s): Heat Tolerance Assessment
Intervention type(s): Other
Intervention description(s): 60-90 minutes exercise in hot (34 °C; 45% R.H.) conditions at 60%VO2max
Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Individuals who have experienced a recent exertional heat illness and matched controls with
        no previous history of exertional heat illness
      
Biospecimen description: 
      Saliva; plasma; stool
GW679769 In Fibromyalgia
Condition: Depressive Disorder; Depression; Fibromyalgia
MeSH terms: Fibromyalgia; Myofascial Pain Syndromes; Depression; Depressive Disorder
Study type: Observational

Summary: 
      The purpose of the study is to investigate safety, tolerability and efficacy of oral GW679769
      up to 120 mg dose compared to placebo in patients with ACR(American College of
      Rheumatology)-defined fibromyalgia, co-morbid with depression.
    


Intervention name(s): GW679769
Intervention type(s): Drug
Intervention MeSH terms: Casopitant
Keywords: NK1-antagonist; Depression; Fibromyalgia; GW679769; Outpatient
Lactacyd Radiance (Lactic Acid) Prophetic Patch Test
Condition: Hygiene
Study type: Interventional
Phase: Phase 2

Summary: 
      Primay objective:

      To evaluate the potential of the products in eliciting adverse skin reaction.
    


Intervention name(s): Lactic Acid; Distilled water
Intervention type(s): Drug; Other
Intervention description(s): Application of occlusive patches containing test product. For 24 hours and repeat 2 weeks later for participants with no reaction to Lactacyd Radiance; Application of patches containing distilled water for 24 hours
Other intervention name(s): Lactacyd Radiance
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Unilateral Laparoscopic Diathermy Adjusted to Ovarian Volume
Condition: PCOS
MeSH terms: Hyperthermia
Study type: Interventional

Summary: 
      The objective of our study was to compare the efficiency of the right ULOD using thermal
      doses adjusted to ovarian volume (60 J/cm3) with the BLOD method at constant dose and to
      assess treatment efficiency.
    

Detailed description: 
      The study included 96 infertile, clomiphene citrate-resistant women with polycystic ovary
      syndrome (PCOS), who underwent either unilateral or bilateral laparoscopic diathermy at the
      Clinical Hospital Split, Croatia. PCOS was diagnosed following the Rotterdam consensus
      criteria. In the ULOD group, we treated the right ovary with thermal dose of 60 J applied per
      one cubic centimeter of ovarian. In the comparator, BLOD group, all patients received 600 J
      per ovary. The follow-up period encompassed six menstrual cycles for all subjects.Sample size
      was based on the test of the primary hypothesis that ULOD treatment would result in a higher
      ovulation rate than BLOD. In our pilot study in 61 patients, ovulation rates were estimated
      to 44% in the BLOD arm and 69% in the ULOD arm. Assuming 5% significance and 80% power, we
      calculated that the minimal sample size for a one-sided test had to be 96 patients.

      The aims of our prospective study:

        1. Compare the efficiency of the right ULOD using thermal doses adjusted to ovarian volume
           (60 J/cm3) with the BLOD method at constant dose and to assess treatment efficiency and
           predict ovulatory response based on clinical parameters (right or left ovary and its
           volume) and received thermal doses.

        2. Evidence the effects of ULOD using thermal doses adjusted to ovarian volume on endocrine
           (changes in androgen and AMH) and reproductive outcomes (ovulation rate) in
           clomiphene-resistant women with PCOS.

        3. To determine whether unilateral laparoscopic ovarian drilling (ULOD) using thermal doses
           adjusted to ovarian volume diminishes ovarian reserve less than bilateral LOD (BLOD)
           using a fixed thermal dose
    

Intervention name(s): Unilateral laparoscopic drilling; Bilateral laparoscopic drilling
Intervention type(s): Procedure; Procedure
Intervention description(s): Unilateral laparoscopic drilling with diathermy adjusted to ovarian volume; Bilateral laparoscopic drilling with fixed doses energy
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: polycystic ovary syndrome,laparoscopic ovarian drilling
PENG Block Versus LP Block for THA Postop Pain
Condition: Pain, Postoperative; Hip Pain Chronic
MeSH terms: Pain, Postoperative
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this randomized, double blinded, prospective study is to compare the
      postoperative analgesia provided by the PENG block to that provided by the LPB for patients
      undergoing primary anterior approach THA.
    

Detailed description: 
      Regional anesthesia procedures represent a common modality for postoperative analgesia after
      total hip arthroplasty surgeries (THA). The standard practice many years has been the Lumbar
      Plexus block (LPB), which anesthetizes the L1-L5 lumbar nerve roots1. While the LPB offers
      analgesia from the associated sensory block, it also blocks motor fibers, leading to lower
      extremity weakness that could potentially delay the patient's ability to participate in early
      physical therapy and may thereby delay discharge. In the past several years, newer regional
      anesthesia block approaches have been described and investigated in an attempt to provide
      patients with postoperative analgesia while avoiding associated muscle weakness, facilitating
      earlier physical therapy participation and discharge. One such nerve block is the
      peri-capsular nerve group (PENG) block, which anesthetizes the articular branches of the
      femoral, obturator, and accessory obturator nerves providing sensory innervation to the hip
      joint capsule without consistently causing lower extremity weakness2. Some institutions are
      utilizing the PENG block to provide postoperative analgesia and facilitate early
      mobilization. There are currently no prospective studies that directly compare the efficacy
      of LPB to PENG block for providing postoperative analgesia after THA.
    

Intervention name(s): Peri-capsular Nerve Group (PENG); Lumbar Plexus Block (LPB)
Intervention type(s): Drug; Other
Intervention description(s): PENG block for postoperative pain management; LPB for postoperative pain management
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
A Bio-equivalence Study of Sofosbuvir From Sofodelevier 400 mg Film Coated Tablets (Al-debeiky Pharma, Egypt) Versus Sovaldi 400 mg Tablets (Gilead Sciences, Canada)
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      Comparative randomized, single dose, three way three sequence two treatment partial replicate
      crossover open-label study to determine the bioequivalence of Sofosbuvir from Sofodelevier
      400 mg F.C.T (Al-debeiky pharma, Egypt) versus Sovaldi 400 mg Tablets (Gilead Sciences,
      Canada)
    

Detailed description: 
      Primary Pharmacokinetic Parameters: Cmax, Area under cover (AUC0→t and AUC0→∞ ) Secondary
      Pharmacokinetic Parameters: Ke, tmax and t1/2e. ANOVA using 5% significance level for
      transformed (with the 90% confidence intervals) and untransformed data of Cmax, AUC0→t and
      AUC0→∞ and for untransformed data of Ke, tmax and t1/2e. The confidence intervals of
      logarithmically transformed Test/Reference ratios for Cmax, AUC0→t and AUC0→∞ to be within
      80.00-125.00%.

      A comprehensive final report will be issued upon the completion of the study.
    

Intervention name(s): Sofodelevier; Sovaldi (fist dose); Sovaldi (second dose)
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 1 tablet contains 400 mg sofosbuvir; 1 tablet contains 400 mg sofosbuvir; 1 tablet contains 400 mg sofosbuvir
Other intervention name(s): Sovaldi; Sovaldi; Sovaldi
Intervention MeSH terms: Sofosbuvir
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
A Trial to Evaluate DR-2021 in Women With Secondary Amenorrhea
Condition: Amenorrhea
MeSH terms: Amenorrhea
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a multicenter trial to compare the effectiveness of 4 doses of DR-2021 with placebo
      and oral micronized progesterone in inducing withdrawal bleeding in women with secondary
      amenorrhea.
    

Detailed description: 
      In this multicenter trial patients will be randomized to receive DR-2021, oral micronized
      progesterone, and placebo to evaluate the effects on withdrawal bleeding in women with
      secondary amenorrhea. Patients will be treated for 10 days and study participation will be
      approximately 24 days. Patients will undergo a physical exam including a pelvic and breast
      exam. Patients will be required to complete bleeding and spotting information daily in a
      diary.
    

Intervention name(s): DR-2021a; DR-2021b; DR-2021c; DR-2021d; DR-2021e; Placebo
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Other
Intervention description(s): 1 capsule daily for 10 days; 1 capsule daily for 10 days; 1 capsule daily for 10 days; 1 capsule daily for 10 days; 1 capsule daily for 10 days; 1 matching placebo capsule for 10 days
Other intervention name(s): Micronized progesterone; Micronized Progesterone; Micronized Progesterone; Micronized Progesterone
Intervention MeSH terms: Progesterone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: secondary amenorrhea; progesterone
White Rice and Effect of Gellan Gum on Glucose Responses by MRI
Condition: Glycemic Response to Feeding in Healthy Participants
Study type: Interventional

Summary: 
      Rice is a staple food for over half the world's population. High consumption of white rice
      has been linked with high obesity and increased risk for type 2 diabetes. However, it is
      still the favoured type of rice among consumers, contributing to the observed increasing
      trends in diet-related diseases in countries with high rice consumption. Controlling the
      properties of white rice products (e.g. reducing the glycaemic index and/or increasing
      satiety) with relatively simple interventions could contribute to producing foods with
      health-promoting digestibility profiles.

      One way to reduce the glycaemic index of white rice is through processing. Addition of food
      thickeners (called hydrocolloid gums) has previously been shown to reduce the digestibility
      of foods.

      This work will test the hypothesis that gellan gum is a simple way to manipulate the body's
      glucose response to a white rice which in turn will have health-promoting effects. MRI
      imaging will be used to monitor the gastrointestinal responses.
    

Detailed description: 
      Addition of hydrocolloids has previously been shown to reduce the digestibility of foods.
      Hydrocolloids are polysaccharides used to increase viscosity and gelatinization and have many
      other applications in the food industry. However, there is a lack of mechanistic
      understanding on how these hydrocolloids may act during digestion in the human body.
      Preliminary in-house data suggested that the addition of gellan gum to rice cooking may
      reduce digestibility rates though mechanisms yet to be understood. This work will test the
      hypothesis that gellan gum can be used to manipulate white rice product properties to enhance
      health-promoting glycaemic, gastrointestinal and satiety responses in healthy human
      participants.

      Aims:

      1. to collect pilot data on postprandial glucose levels of isoenergetic test meal made from
      rice and Gellan Gum 2 . to collect data on their gastric emptying and satiety. 3. to compare
      postprandial glucose levels, gastric emptying and satiety for the treatments 4. to explore
      relationships between glucose levels, gastric emptying and satiety.
    

Intervention name(s): White rice; Gellan gum
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Jasmine rice 179g of cooked weight; Food grade hydrocolloid polysaccharide 5.5g dissolved in 356g cooking water containing 185g rice
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: randomised 2-way crossover study
Masking: Single (Participant)
Primary purpose: Basic Science
Keywords: white rice; glycemia; gellan gum; hydrocolloids
Initial Evaluation of Investigational Lenses Manufactured on a New Production Line
Condition: Visual Acuity
Study type: Interventional

Summary: 
      This study is a randomized, 4-visit, subject-masked, 2x3 bilateral crossover, dispensing
      trial. Each study lens will be worn bilaterally in a daily wear (DW) modality for at least 6
      hours per day and 5 days per week for approximately two weeks each. The subject will wear
      either the Test or Control lens twice and the other study lens once.
    


Intervention name(s): CONTROL Lens; TEST Lens
Intervention type(s): Device; Device
Intervention description(s): Acuvue OASYS; senofilcon A
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Evaluation of the Intraoperative Accuracy of 3D-planned and Guided Osteotomies of the Hand and Forearm
Condition: Posttraumatic or Congenital Bone Deformity
MeSH terms: Congenital Abnormalities
Study type: Interventional

Summary: 
      Target of the study is to evaluate the reduction accuracy of 3D computer-planned osteotomies
      that are performed with patient-specific instruments.

      Due to the higher accuracy achieved it is expected that complaints can be resolved or
      effectively revealed. The Research hypothesis to prove is "The medical product permits the
      surgical reduction of deformed bones of the hand and forearm (radius, ulna, distal humerus,
      carpal, metacarpal, and finger bones) by corrective osteotomy within an accuracy of 2 mm and
      2º. Secondary outcome is an assessment of the surgical outcome using the "Disabilities of the
      Arm, Shoulder and Hand" (DASH) and the "Patient related wrist Evaluation" (PRWE) scores.
    


Intervention name(s): EUDAMED CIV-14-03-011940
Intervention type(s): Device
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Observational Study of Approaches to Lipid-Lowering Therapy in Russian Patients With Coronary Heart Disease <<Treat to Goal>> (Study P05464)
Condition: Coronary Heart Disease; Hypercholesterolemia
MeSH terms: Heart Diseases; Coronary Disease; Coronary Artery Disease; Myocardial Ischemia; Hypercholesterolemia
Study type: Observational

Summary: 
      This study is being performed to evaluate what variants of lipid-lowering therapy are used in
      Russian clinical practice in coronary heart disease (CHD) patients with hypercholesterolemia
      in whom the initial statin therapy did not achieve low density lipoprotein-cholesterol
      (LDL-C) goals. Additionally, the efficacy and safety of all variants of modified
      lipid-lowering therapy are to be evaluated.
    

Detailed description: 
      Given the observational nature of this study and that the assessment of a specific hypothesis
      is not foreseen, statistical assumption is not planned and the sample size calculation was
      not performed.

      Taking into consideration the available data on the established safety profile of the therapy
      with statins and combination of ezetimibe with statins it has been suggested that a sample
      size of 750 patients will be sufficient to identify adverse events profile.

      The treatment effects will be characterized by descriptive and frequency parameters.
    

Intervention name(s): Ezetimibe; Statin
Intervention type(s): Drug; Drug
Intervention description(s): Dosage determined by the investigator based on standard and applicable routine clinical practice for CHD and hypercholesterolemia patients; Statin titration for the Statin Dose Titration group, and new statin treatment and dosage for the New Statin group, determined by the investigator based on standard and applicable routine clinical practice for CHD and hypercholesterolemia patients
Other intervention name(s): SCH 58235; Ezetrol
Intervention MeSH terms: Ezetimibe
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients with established diagnosis of coronary heart disease (CHD) and
        hypercholesterolemia who did not achieve the target values for total cholesterol (TC) and
        low density lipoprotein-C (LDL-C) with existing statin therapy