bioihbjkbjnl/mcl2 huggingface dataset:
Prospective Randomized On-X Versus SJM Evaluation Trial
Condition: Heart Valve Disease
MeSH terms: Heart Valve Diseases
Study type: Interventional

Summary: 
      The study hypothesizes that rate of thromboembolic complications of the On-X prosthesis is
      reduced as compared to the SJM prosthesis.
    

Detailed description: 
      The study is a multi-centre, randomized trial that will sequentially enroll up to 500
      eligible patients in each group from up to 10 participating study centres internationally to
      test the hypothesis.
    

Intervention name(s): On-X Heart valve replacement; SJM Heart valve replacement
Intervention type(s): Device; Device
Intervention description(s): On-X Heart valve replacement; SJM Heart valve replacement
Other intervention name(s): On-X Prosthetic Heart Valve; St. Jude Medical Prosthetic Heart Valve
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: thromboembolism; mechanical heart valves; randomized
Ropivacaine Versus Bupivacaine for Spinal Anaesthesia in Patients Undergoing Unilateral Lower Limb Surgery
Condition: Anesthesia,Spinal
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to compare the efficacy, duration of motor block until return to
      normal function in the non-operated leg after the start of injection, of ropivacaine 5 mg/ml
      and bupivacaine 5 mg/ml when used for spinal anaesthesia in patients undergoing unilateral
      lower limb surgery.
    


Intervention name(s): Ropivacaine; Bupivacaine
Intervention type(s): Drug; Drug
Intervention MeSH terms: Bupivacaine; Ropivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Patients ASA category I ～ II; Unilateral Lower limb surgery; Spinal Anesthesia
Rate of Spontaneous Stone Passage as Assessed Using Urinary Ultrasonography and Direct Urinary System Radiography
Condition: Ureteral Calculi; Masturbation
MeSH terms: Ureteral Calculi; Ureterolithiasis; Calculi
Study type: Interventional

Summary: 
      To evaluate the effect of masturbation on the spontaneous expulsion of distal ureteral stones
      5-10 mm in size.
    

Detailed description: 
      This prospective randomized controlled study was performed between February 2018 and March
      2020 after obtaining ethics committee approval.A total of 128 men with distal ureteral stones
      were randomly divided into 3 groups. All patients received standard medical therapy. Patients
      in group 1 (n=43) were instructed to masturbate at least 3-4 times a week, patients in group
      2 (n=41) received tamsulosin 0.4 mg/day, and patients in group 3 (controls, n=44) received
      standard medical therapy alone. Rates of expulsion, need for analgesic, and ureterorenoscopic
      lithotripsy were compared between the groups.
    

Intervention name(s): Endoscopic ureterolitotripsy
Intervention type(s): Procedure
Intervention description(s): Endoscopic ureterolithotripsy
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Growth, Dietary Intakes and Feeding Behaviors of Children With Cerebral Palsy Who Have Chewing Disorders
Condition: Cerebral Palsy; Mastication Disorder; Malnutrition; Growth Delay
MeSH terms: Cerebral Palsy; Malnutrition
Study type: Observational

Summary: 
      The nutritional status of CP children may be decreased when children have chewing disorders
      too due to insufficient solid food intake. The objective of this study was to investigate
      growth, dietary intakes and feeding behaviours of children with CP who have chewing
      disorders, and to compare them with their healthy peers.
    

Detailed description: 
      Chewing function is defined as a rhythmic oral motor activity to comminute and soften solid
      food. Children with CP often have difficulty in transitioning to solid food. The main food of
      45% of them was liquids and semisolids. It was reported that food/fluid textures were
      modified for 39% of children in which with poorer gross motor function tended to receive a
      greater proportion of energy from fluids in their diets and fewer chewable foods. Lopes et
      al. investigated dietary patterns of 90 children with CP aged 2-13 years by using the 24-hour
      recall method and found that 26% and 9% of children had difficulty in chewing and swallowing
      of solid foods, respectively. However, the diet of children with normal feeding skills
      includes liquid, semisolid and/or solid foods together so unable to take any solid food may
      affect sufficient food intake and nutritional status of children with CP who have chewing
      disorders. The significance of this situation is that nutritional status has effects on
      general health and quality of life of children and their families. Therefore, it is important
      to show the nutritional status of CP children with chewing disorders to increase the
      awareness of both parents and healthcare providers on solid food intake and solve the problem
      early. The objective of this study was to investigate growth, dietary intakes and feeding
      behaviours of children with CP who have chewing disorders, and to compare them with their
      healthy peers.
    

Intervention name(s): Growth, feeding evaluation
Intervention type(s): Other
Intervention description(s): Z-scores of the nutritional indicators were calculated. The dietary assessment was performed by using the 24-hour recall method. The Behavioural Paediatrics Feeding Assessment Scale (BPFAS) was used to assess both frequencies of negative feeding behaviours and parents' problematic perceptions
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Group I (study group) (n=50) included CP children with chewing disorders and group II
        (control group) (n=35) included healthy children without chewing disorders
The Effect of Vitamin D3 on the Rate of Orthodontic Tooth Movement
Condition: Tooth Position Anomalies
Study type: Interventional

Summary: 
      The aim of this study is to evaluate the effect of vitamin D3 deficiency on the rate of
      orthodontic tooth movement in both conventional and accelerated orthodontic. Assessing both
      lower anterior teeth alignment and the rate of maxillary canine retraction.
    

Detailed description: 
      To evaluate the effect of vitamin D deficiency on the rate of orthodontic tooth movement in
      both conventional and accelerated orthodontic, additionally find the effect of vitamin D
      deficiency on molar anchorage loss, canine rotation, lower incisor crowding alignment time,
      pain experienced by the patient during OTM and rate of orthodontically induce apical root
      resorption.
    

Intervention name(s): Micro-osteoperforation
Intervention type(s): Procedure
Intervention description(s): Micro-osteoperforation Mini-implant facilitated micro-osteoperforation (MOPs) were placed in the experimental side before canine retraction. Three MOPs were placed distal to canine on experimental sides in all group.
Other intervention name(s): MOP
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Orthodontic, tooth movement, acceleration
Lollipop on Gastric Emptying
Condition: Gastric Emptying
Study type: Interventional

Summary: 
      To investigate the effect of chewing lollipop on gastric volume and gastric emptying in
      healthy volunteers drinking water.
    


Intervention name(s): lollipop
Intervention type(s): Other
Intervention description(s): chewing lollipop for 10 minutes
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Effect of Gastric Bypass Surgery on Pancreatic Islets and Incretin Function
Condition: Obesity
MeSH terms: Obesity
Study type: Observational

Summary: 
      The study aims at describing the acute and subacute changes after Roux-en-Y (RYGB) gastric
      bypass in insulin secretion from the beta cell and glucagon secretion from the alpha cell as
      well as the stimulatory effect of the incretins on the pancreatic islets. RYGB is a bariatric
      procedure that changes the gastrointestinal anatomy and has been demonstrated to cause
      remission of type 2 diabetes shortly after the operation, before any significant weight loss.
      The altered transit of nutrient through the gastrointestinal tract after the operation is
      thought to play a key role in this remission and studies have shown significant changes in
      the secretion of gut hormones, namely the incretin hormone glucagon-like peptide-1 (GLP-1).
      However it is unknown whether the secretory function of the pancreatic islets as well as the
      stimulatory effect of the incretin hormones is changes postoperatively.
    


Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Subjects are recruited from the population undergoing gastric bypass surgery at Hvidovre
        Hospital
      
Biospecimen description: 
      Plasma and serum specimens are retained
    
Keywords: Obesity; Roux-en-Y gastric bypass; Incretin hormones; Beta cell function
Computerized Screening, Brief Intervention, and Referral to Treatment in Primary Care
Condition: Substance Use Disorder
MeSH terms: Substance-Related Disorders
Study type: Interventional

Summary: 
      This is a randomized, controlled clinical trial to evaluate the effect of a computerized
      screening, assessment, and brief intervention on substance use in patients recruited from a
      primary care clinic. Study participants will be assigned to one of the following 4 study
      groups: computerized health screening alone (standard care) (SC); computerized
      assessment-only intervention (CA); computerized assessment followed by a computer-directed
      motivational intervention (CACI); or computerized assessment followed by a
      therapist-delivered motivational intervention (CATI). Data regarding substance use, medical
      and psychosocial functioning, and economic outcomes will be collected.

      The investigators hypothesize that patients randomized to CACI and CATI will be more likely
      to report drug abstinence at the 3-month follow-up visit and will show greater reductions in
      drug use at 1, 3 and 6 months follow-up than patients assigned to CA or SC. Similarly,
      patients in the CACI and CATI groups will report greater reductions in HIV risk behaviors,
      lower rates of medical and psychosocial problems, and increased economic gains at the 6-month
      follow-up. In addition, patients in the assessment only intervention (CA) will have outcomes
      superior to those found for SC patients. A cost-effectiveness analysis will also be done
      comparing economic costs associated with CA, CACI and CATI and their relationship to
      substance use reductions and related improvements in medical and psychosocial outcomes at the
      6 month follow-up.
    


Intervention name(s): Computerized brief intervention; Computerized health screening; Computerized assessment; Therapist-delivered motivational intervention
Intervention type(s): Behavioral; Behavioral; Behavioral; Behavioral
Intervention description(s): Intervention based on Motivational Interviewing technique; Behavioral intervention; Behavioral intervention; Behavioral intervention
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: substance use; drug use; drug abuse
Clinical Effect of Allogeneic Meniscus Transplantation
Condition: Meniscus Lesion
Study type: Interventional

Summary: 
      In this study, patients who underwent allogeneic meniscus transplantation and meniscus
      resection were followed up for more than 10years to evaluate the long-term efficacy and
      explore the cartilage protective role of meniscus transplantation.
    

Detailed description: 
      To investigate the long-term clinical effect of allogeneic meniscus transplantation, IKDC
      score, Lysholom score, Tegner score, VAS score, etc. were used to compare the clinical
      effects of allogeneic meniscus transplantation, and the progress of knee joint degeneration
      and cartilage injury was evaluated through X-ray and MRI.
    

Intervention name(s): Meniscus Allograft Transplantation; Meniscectomy
Intervention type(s): Procedure; Procedure
Intervention description(s): patients received surgery of Meniscus Allograft Transplantation; patients received surgery of Meniscectomy
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Comparison of Trunk Muscle Performance Between Sprinters With and Without Hamstring Strain Injury History
Condition: Hamstring Injury
MeSH terms: Wounds and Injuries
Study type: Observational

Summary: 
      The aim of this study is to:

        1. Compare trunk muscle performance between sprinters with and without HSI history

        2. Investigate whether running speed influences the differences on trunk muscle activity
           between these two groups
    

Detailed description: 
      Hamstring strain injury is one of the most common injuries in the lower extremities. As
      running speed increases, the force and load on the hamstring muscles significantly increase,
      thereby increasing the risk of injury. Trunk muscles are connected thigh muscles through the
      pelvis, and poor trunk muscle capacity of maintaining stability affect the muscle length of
      the lower limbs during movement, reducing their contractile tension and increasing the risk
      of injury. Earlier literature also indicated that poor trunk muscle performance is related to
      the occurrence of lower extremity sport injuries. However, literature on the relationship
      between trunk muscle performance and hamstring strain injury is scarce. Testing methods of
      existing research have failed to fully reflect the actual circumstances of sprinting.
      Moreover, previous studies have predominantly focused on soccer players. However, the running
      mechanics of soccer player and sprinter are slightly different. Currently, there is lack of
      research investigate the relationship between trunk muscle performance and hamstring strain
      injury in sprinters.Therefore, the aim of this study is to: (1) Compare trunk muscle
      performance between sprinters with and without HSI history, (2) nvestigate whether running
      speed influences the differences on trunk muscle activity between these two groups
    

Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        -  Age between 16 to 30 years old

          -  Sprinters who specialize in 100, 200, 400 meters, or 100, 400 metres hurdles

          -  Participates in sprint training ≥ three times a week

          -  Without any pain when participation in sporting activity
      
Keywords: Hamstring Strain Injury; Trunk Muscle Performance; Hip Muscle Performance; Sprinter
Melphalan 200 mg/m2 Versus Melphalan 100 mg/m2 in Newly Diagnosed Myeloma Patients
Condition: Multiple Myeloma; Diagnosis
MeSH terms: Multiple Myeloma; Neoplasms, Plasma Cell
Study type: Interventional
Phase: Phase 3

Summary: 
      In this study will be randomised before induction treatment either to receive two courses of
      melphalan 200 mg/m2 (MEL200) or two courses of melphalan 100 mg/m2 (MEL100). Informed consent
      will be obtained upon enrolment. Inclusion criteria included: diagnosis of untreated Durie e
      Salmon stage IIA-IIIB measurable multiple myeloma; age < 65 years. Exclusion criteria
      included: prior treatment for myeloma; abnormal cardiac function, defined as systolic
      ejection fraction <50%; abnormal pulmonary spirometry test; serum bilirubins > 2.5 times
      normal and ALAT and/or ASAT > 2 times normal; seropositivity for HIV, HCV or HBV, active
      non-hematologic malignancies.

      Induction therapy, PBSC mobilization, and autografting Initial treatment plan included
      induction chemotherapy with 2 courses of vincristine, 1 mg/m2 on day 1, adriamycin, 50 mg/m2
      on day 1, and dexamethasone, 40mg/day days 1-4, administered 28 days apart, followed by
      peripheral blood stem cell (PBSC) mobilisation and harvest after 1 or 2 cycles of
      cyclophosphamide, 4 g/m2, and G-CSF, 10 ug/kg given i.v. or subcutaneously. After at least
      one month from PBSC collection, autografting consisted of melphalan, 200 mg/m2 or melphalan,
      100 mg/m2, on day -2, and cryopreserved PBSC infusion on day 0. Patients received G-CSF, 5
      ug/kg, from days +3 until neutrophil count > 1000/ul were achieved.

      Supportive care and toxicity grading Following autografting, all patients received standard
      prophylaxis against bacterial and fungal infections; herpes simplex and varicella-zoster
      virus reactivation; and Pneumocystis carinii. Cytomegalovirus CMV reactivation was monitored
      through levels of CMV antigenemia and/or serum CMV DNA levels and treated with ganciclovir or
      foscarnet as clinically indicated. Standard criteria (Common Toxicity Criteria version 3.0)
      were used for grading hematological and non-hematological toxicity.
    


Intervention name(s): Autologous transplantation
Intervention type(s): Procedure
Intervention description(s): Tandem autologous transplantation Melphalan 100 mg/m2 versus Melphalan 200 mg/m2
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Myeloma; Melphalan; Autologous transplantation
Bioequivalence Study of Lopinavir/Ritonavir 200/50 mg Film Tablet (World Medicine Ilac, Turkey) Under Fasting Conditions
Condition: Bioequivalence
Study type: Interventional
Phase: Phase 1

Summary: 
      A single dose of Reference product containing 200 mg lopinavir and 50 mg ritonavir fixed dose
      combination and a single dose of Test product containing 200 mg lopinavir and 50 mg ritonavir
      fixed dose combination or vice versa; administered with 240 mL of water at room temperature,
      in each period under fasting conditions.
    

Detailed description: 
      The subjects will me isolated at the dorm during 5 days before the dosing.
    

Intervention name(s): Lopinavir/Ritonavir 200 mg/50 mg Film Tablet; Lopinavir/Ritonavir 200 mg/50 mg Film Coated Tablet
Intervention type(s): Drug; Drug
Intervention description(s): Lopinavir/Ritonavir film tablet containing 200 mg lopinavir and 50 mg ritonavir (World Medicine-Turkey).; Lopinavir/Ritonavir film coated tablet containing 200 mg lopinavir and 50 mg ritonavir(AbbVie Deutschland GmbH & Co.-Germany)
Other intervention name(s): Orvical 200 mg/50 mg Film Tablet; Kaletra 200 mg/50 mg Film Coated Tablet
Intervention MeSH terms: Ritonavir; Lopinavir
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Single Oral Dose,Two Treatment,Four-period,Full-replicated,Cross-over
Masking: None (Open Label)
Primary purpose: Other
Keywords: COVID-19 drug treatment; Ritonavir; Lopinavir; Antiviral Agents; Kaletra; Novagenix; Farmagen
A Study to Assess the Effect of AZD0780 on the Pharmacokinetics of Rosuvastatin.
Condition: Dyslipidemia
MeSH terms: Dyslipidemias
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of the study is to assess the effect of AZD0780 on the pharmacokinetics of
      rosuvastatin, and to assess the safety and tolerability of AZD0780 single dose, in healthy
      participants administered alone and in combination with rosuvastatin.
    

Detailed description: 
      Eligible participants will be randomized, in a 1:1 ratio into 2 of the treatment arms. Each
      participant will receive 2 treatments in total throughout the study. The following treatments
      will be given in randomized order in fasting state:

      Treatment A: single dose of rosuvastatin tablet alone

      Treatment B: single dose of rosuvastatin tablet + AZD0780 tablet

      The study will comprise:

        1. A Screening Period of maximum 28 days.

        2. Two Treatment Periods up to 3 days

        3. A follow-up period of 10 to 12 days after the last administration of the study drug.

      Following an overnight fast (minimum 10 hours) participants will receive either of the two
      treatments and will remain resident in the Clinical Unit until up to 48 hours after dosing of
      the study drug (up to Day 3).

      The total duration of the study will be up to 9 weeks.
    

Intervention name(s): AZD0780; Rosuvastatin
Intervention type(s): Drug; Drug
Intervention description(s): AZD0780 will be administered orally as a single dose after an overnight fast of at least 10 hours with approximately 240 mL of water.; Rosuvastatin will be administered orally as a single dose after an overnight fast of at least 10 hours with approximately 240 mL of water.
Intervention MeSH terms: Rosuvastatin Calcium
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Participants will be randomized, in a 1:1 ratio into each of the treatment arms prior to the study commencing. Each participant will receive 2 treatments in total throughout the study.
Masking: None (Open Label)
Primary purpose: Other
Keywords: Hypercholesterolemia; elevated Low-density lipoprotein-cholesterol (LDL-C) levels; Drug-drug interaction; Healthy Participants