bioihbjkbjnl/mcl2 huggingface dataset:
Radiological and Clinical Efficacy of a Hybrid Spinal Implant ("Topping Off"): a Mono-center, Prospective Clinical Trial
Condition: Spine Surgery
Study type: Interventional

Summary: 
      The study aim is to show the effectiveness of a hybrid system (DTO) regarding clinical
      outcome and radiological alteration in a single-center prospective setting.
    

Detailed description: 
      Posterior spondylodesis and monosegmental intervertebral cage plus flexible instrumentation
      of the superiorly adjacent segment (Dynesys DTO).

      Planned follow-up visits up to 48 months with documentation of health-related outcome
      measurement instruments and radiological control of possible segment alteration and
      device-related complication.
    

Intervention name(s): Dynesys DTO device (Zimmer Spine, Inc.)
Intervention type(s): Device
Intervention description(s): All patients receive posterior hybrid instrumentation.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: All patients requiring lumbar spinal surgery by the use of a hybrid spinal implant (DTO): (1) patients with their first surgical intervention at the lumbar spine, (2) patients with a previous surgical decompression but non-fusion procedure after LSS and (3) patients with medical history of PLIF-/TLIF-technique and later onset of symptomatic ASD within the superior adjacent segment.
Masking: None (Open Label)
Primary purpose: Treatment
Study on the Body Mass Balance and Biotransformation of [14C]-HEC585
Condition: Healthy Volunteer
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a single-centre, open-label, non-randomised, single-dose study in healthy male
      subjects designed to assess the mass balance and biotransformation of [14C]-HEC-585.
    


Intervention name(s): [14C]-HEC585
Intervention type(s): Drug
Intervention description(s): Single Dose = Solution containing 200 mg/100 µCi [14C]-HEC585
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Combination of Coenzyme Q10, Feverfew and Magnesium for Migraine Prophylaxis : a Prospective Observational Study
Condition: Migraine
MeSH terms: Migraine Disorders
Study type: Observational

Summary: 
      Adult patients suffering from migraine according to the criteria of the International
      Headache Society were enrolled by general practitioners (≥2 migraine attacks during previous
      month; exclusion of chronic migraine and medication overuse) and after a one-month baseline
      phase, supplemented with one tablet of 100 mg feverfew, 100 mg coenzyme Q10 and 112.5 mg
      magnesium per day for 3 months.
    

Detailed description: 
      Three visits were planned: V1, V2 on Day 30 (± 10) and V3 on Day 120 (± 10). On V1, after
      checking the inclusion criteria and receiving informed consent, GPs collected demographic
      data, medical and migraine history and information on migraine attacks, associated symptoms
      and rescue medications via an electronic case report form. V1 was followed by a one-month
      observation period (baseline phase) during which migraine treatment of patients was not
      modified. From V1 till the end of the study, all patients kept an electronic diary in which
      they reported migraine characteristics (number of days with migraine headache, intensity,
      associated symptoms and concomitant medications). On the second visit (V2; Day 30 ± 10),
      eligibility of patients was verified: patients with less than 2 or more than 15 migraine
      attacks during baseline phase and patients unwilling to be supplemented with the combination
      were excluded from the study. Eligible patients were advised to start supplementation. On V3
      (Day 120 ± 10), information provided in patient's diary and compliance with supplementation
      were checked.

      The day before V2 and V3, patients had to complete the French migraine-related quality of
      life questionnaire (Qualité de Vie et Migraine [QVM]) and the Hospital Anxiety and Depression
      Scale (HADS).

      The study was conducted in accordance with articles L.1121-1 and R1121-2 of the French public
      health code defining non interventional studies; all the acts were practised and products
      used in a usual way without any additional or unusual procedure of diagnosis or surveillance.
    

Intervention name(s): Antemig
Intervention type(s): Dietary Supplement
Intervention description(s): Participants were instructed to take one tablet every morning for three months.
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Adult patients were recruited by general practitioners (GPs). Patients had to suffer from
        migraine with or without aura diagnosed according to the criteria of the International
        Classification of Headaches Disorders III (ICHD III 1.1 and 1.2)
Temperature and Analgesia Monitoring During Cardial Parmonary Bypass
Condition: Coronary Artery Disease
MeSH terms: Coronary Artery Disease
Study type: Observational

Summary: 
      1. Investigator will apply IOC2 to reflect the depth of analgesic during hypothermia in CPB
           period.

        2. effectiveness of IOC2 monitoring for anesthetic depth versus commonly used vital sign
           monitoring based on factors such as blood pressure and heart rate.

        3. Evaluate the other sedation co-relation measurement, include BIS , IOC2 to reflected the
           consciousness during the operation.

        4. Evaluate the other hemodynamic index, include CO, SVV, CVP, PPV to reflect the
           circulation function , and the effect to the IOC2 and IOC1.

        5. Describe the trend of all the measurement. detect the variation of the index during the
           temperature change during the CPB.
    

Detailed description: 
      In this study,

        1. Investigator will apply IOC2 to reflect the depth of analgesic during hypothermia in CPB
           period.

        2. Furthermore, investigator evaluated the effectiveness of IOC2 monitoring for anesthetic
           depth versus commonly used vital sign monitoring based on factors such as blood pressure
           and heart rate.

        3. Evaluate the other sedation co-relation measurement, include BIS , IOC2 to reflected the
           consciousness during the operation.

        4. Evaluate the other hemodynamic index, include CO, SVV, CVP, PPV to reflect the
           circulation function , and the effect to the IOC2 and IOC1.

        5. Describe the trend of all the measurement. detect the variation of the index during the
           temperature change during the CPB.
    

Intervention name(s): noninvasive analgesia measurement
Intervention type(s): Device
Intervention description(s): noninvasive analgesia measurement using index of consciousness(IOC2)
Other intervention name(s): index of consciousness(IOC2)
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        the patients schedule undergoing coronary artery bypass surgery
Efficacy of Cricoid Pressure in Occluding the Esophageal Entrance: A Glidescope ® Study
Condition: Aspiration
Study type: Interventional

Summary: 
      This investigation was designed to assess the patency of the esophageal entrance during
      cricoid pressure (CP) in anesthetized, paralyzed obese and non obese patients using the
      Glidescope ® video laryngoscope (GVL).
    

Detailed description: 
      Eighty-nine patients undergoing surgeries necessitating general anesthesia and tracheal
      intubation were enrolled in this study. Group 1 (OB) including obese patients (n= 59) was
      undergoing bariatric surgery. Following rapid sequence induction/intubation (RSII) anesthesia
      with cricoid pressure, clear view of the vocals cord and the entrance to the esophagus were
      assessed using Glidescope® video laryngoscope before intubation and following intubation.
      Following securing the airway, efficacy of cricoid pressure was tested by the capability to
      insert gastric tubes (20 and 38 Fr) under direct vision using GVL. Group 2 (NOB) including
      non-obese patients (n=30) was undergoing moderate surgery requiring tracheal intubation under
      general anesthesia. Efficacy of cricoid pressure was also tested similarly using GT's (20 and
      38 Fr) following induction of anesthesia and before intubation. Inability of GT insertion was
      recorded as non-patent esophagus (effective CP) and successful insertion of GT was recorded
      as patent esophagus (ineffective CP). Then CP was released and insertion of GT achieved for
      correct verification of the esophageal opening position in both groups.
    

Intervention name(s): cricoid pressure
Intervention type(s): Other
Intervention description(s): The current study test by direct visual evidence the occlusion of esophageal entrance during application CP. The closure of the lumen was further demonstrated by the inability to introduce a GT into the esophagus during CP.
Other intervention name(s): Glidescope
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Prevention
Palliative Radiofrequency Ablation in Metastatic Renal Cell Carcinoma Patients
Condition: Carcinoma, Renal Cell
MeSH terms: Carcinoma; Carcinoma, Renal Cell
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of this study is to evaluate efficacy and safety of Radiofrequency ablation in
      metastatic renal cell carcinoma patients with primary tumor less than 5 cm before medical
      treatment. Ablation may allow for reduced morbidity and may increase the likelihood of
      patients receiving systemic therapy.
    

Detailed description: 
      Nephrectomy has become an integral part of the management of patients with metastatic kidney
      cancer. Performing nephrectomy in these patients is not without risk, however. The very real
      chance of significant metastatic disease progression during the postoperative period or
      complication before or during surgery that may prolong postoperative recovery could
      potentially delay or prevent the administration of systemic therapy in the postoperative
      period. Patient selection for surgery remains critical for success.

      Radiofrequency ablation (RFA) is a medical procedure where tumor is ablated using microwave
      energy to treat a medical disorder. The benefits of RFA in selected metastatic renal cell
      carcinoma patients with small primary tumor (<5 cm) will be evaluated in this Phase I/II
      study.
    

Intervention name(s): Radiofrequency ablation; Interferon-alpha; Radiofrequency ablation; Sunitinib maleate; Sunitinib maleate
Intervention type(s): Procedure; Procedure; Drug
Intervention description(s): Patients undergo ablation by radiofrequency energy under CT-guidance. RFA continues until the entire tumor is treated. Treatment ceases when the entire lesion has undergone necrosis or the zone of necrosis or significant heat deposition approaches vital neurovascular structures. 38 patients will receive following immunotherapy with Interferon-alpha 9 MIU subcutaneously three times per week, 3 weeks on, 3 weeks off till progression. 38 patients will receive sunitinib maleate 50 mg orally once day, 28 days on, 14 days off till progression. Evaluation for response will be after second cycle.; Patients undergo ablation by radiofrequency energy under CT-guidance. RFA continues until the entire tumor is treated. Treatment ceases when the entire lesion has undergone necrosis or the zone of necrosis or significant heat deposition approaches vital neurovascular structures. 38 patients will receive sunitinib maleate 50 mg orally once day, 28 days on, 14 days off, till progression. Evaluation for response will be after second cycle.; 38 patients with unresected primary tumor will receive sunitinib maleate 50 mg orally once day, 28 days on, 14 days off, till progression. Evaluation for response will be after second cycle.
Intervention MeSH terms: Interferons; Interferon-alpha; Sunitinib; Maleic acid
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: metastatic renal cell carcinoma; radiofrequency ablation
An Open-Label Study of Atomoxetine in Adolescents With Attention-Deficit/Hyperactivity Disorder
Condition: Attention Deficit Hyperactivity Disorder
MeSH terms: Hyperkinesis; Attention Deficit Disorder with Hyperactivity
Study type: Interventional
Phase: Phase 3

Summary: 
      A single arm, open-label, phase 3 multicenter study to evaluate the effectiveness and
      tolerability of atomoxetine (given once daily, target dose 1.2 mg/kg/day), as perceived by
      patients, parents and physicians, and its impact on self-esteem in adolescents (aged 12
      through 17 years) with Attention-Deficit/Hyperactivity Disorder treated as outpatients in
      Germany. An 8-week treatment phase is followed by a 16-week extension period.
    


Intervention name(s): Atomoxetine
Intervention type(s): Drug
Intervention MeSH terms: Atomoxetine Hydrochloride
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
EFFICACY OF ICE PACK THERAPY AFTER IMPACTED THIRD MOLAR SURGERY
Condition: Impacted Third Molar Tooth
MeSH terms: Tooth, Impacted
Study type: Interventional

Summary: 
      this study evaluates the effect of cold application after impacted third molar extractions.
      Patients have bilateral impacted third molar tooth included in this study. Patients do not
      applied cold after extraction of third molar on one side and applied cold cold after
      extraction of third molar on the other side.
    

Detailed description: 
      Extraction of impacted teeth causes a trauma which results in an inflammatory response. Some
      postoperative symptoms may occur such as edema, pain, limitations in mouth opening and
      dysfunction as a consequence of the wisdom tooth extraction surgery.

      Local cold application reduces the magnitude of postoperative symptoms. The physiological
      effects of cold application are as follows: vasoconstriction of blood vessels, blood flow to
      the region decreases, edema and inflammation decreases, slowdown in cell metabolism and a
      decrease in local oxygen demand due to the vasoconstriction effect of the cold. Cold therapy
      also induces muscle constriction which reduces muscle stress, pain and inflammation.
    

Intervention name(s): Cold application
Intervention type(s): Other
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Investigator)
Primary purpose: Supportive Care
Keywords: Ice pack therapy, third molar surgery, swelling, pain, trismus
Comparison of The Success Rates of Four Different Pulpotomy Techniques
Condition: Extensive Decay in Primary Molars
Study type: Interventional
Phase: Phase 3

Summary: 
      This randomized clinical trial was conducted to examine and compare the effectiveness of
      pulpotomy in primary molars treated with calcium silicate based materials including
      Biodentine and two different mineral trioxide aggregate (MTA) products (white ProRoot® MTA
      and MTA Plus®). Ferric sulfate pulpotomy was selected to represent the control group. 116
      primary molars in 29 children were treated by pulpotomy and followed for a period of 24
      months.
    


Intervention name(s): Biodentine; ProRoot (Aggregate); MTA Plus; Ferric Sulfate 20 % Dental Gel
Intervention type(s): Drug; Drug; Drug; Drug
Other intervention name(s): 77509635; 75896452; 85303191; Viscostat
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Split-mouth study design was used
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Pulpotomy; Primary molars
Mechanical Traction Force and Knee Joint Space
Condition: Knee Arthritis
MeSH terms: Arthritis
Study type: Interventional

Summary: 
      the purposes of this crossover study are to Purpose

        1. To determine the most effective traction force for knee joint that can be used in the
           treatment of patients with KOA.

        2. To determine the influence of knee joint traction on ROM ok knee joint flexion and
           extension

        3. To determine the influence of knee joint traction on the flexibility of hamstring
           muscles
    

Detailed description: 
      this study is a pilot study design aiming to determine the most effective mechanical traction
      force used for knee joint treatment. this effectiveness was assessed in favor of the
      separation of the joint surfaces in cm in addition to the hamstring flexibility measured in
      cm and active knee flexion range of motion.

      according to previous literature, there is no consensus regarding the most appropriate
      traction force that can produce statistical and clinically meaningful differences so we
      started this pilot study.

      the results of this study will be used to conduct a larger-scale study using the most
      appropriate traction force on patients having knee osteoarthritis.
    

Intervention name(s): mechanical traction for knee joint
Intervention type(s): Device
Intervention description(s): All participants will receive a single session per condition. This session will consist of continuous mechanical knee traction for 30 minutes while the participant assumes a supine position with the treated limb in semiflexion (30° of flexion). the treated limb will be supported using the traction bed's table that is used for this purpose. The knee position angle will be measured by a standard goniometer. Pelvis and thigh straps will be used to fix the body and prevent slippage during the application of the traction force. A customized leg cuff will be placed around the lower leg (above the ankle joint), and a traction rope will be extending horizontally from the cuff to the traction device. 48 hours of washing out will separate the sessions of different conditions
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: the recruited sample will be subjected to 3 treatment conditions according to the traction force used. pre-post comparisons and between conditions comparisons will be conducted
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Parent/Nurse Controlled Analgesia in the Neonatal Intensive Care Unit
Condition: Abdominal Surgery; Thoracic Surgery
Study type: Interventional

Summary: 
      The aim of this study is to examine the safety and effectiveness of 2 morphine delivery
      systems for post-surgical neonates. The investigators hypothesize that this study will be
      feasible to conduct, and that neonates receiving morphine via a Parent/Nurse Controlled
      Analgesia pump will receive less morphine and experience fewer side effects than neonates
      receiving morphine via continuous opioid infusion.
    


Intervention name(s): Morphine
Intervention type(s): Drug
Intervention description(s): Morphine will be used to control pain post-surgery.
Intervention MeSH terms: Morphine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Neonatal Intensive Care Unit; neonate; pain; morphine; Parent/Nurse Controlled Analgesia
High Intensity Body-weight Circuit Training in Type 2 Diabetics
Condition: Type2 Diabetes
MeSH terms: Body Weight
Study type: Interventional

Summary: 
      Exercise has been shown to be effective at improving fitness, as well as markers of glucose
      tolerance and control, in persons with type 2 diabetes. Recently, several investigations have
      demonstrated that improvements are realized by patients with high intensity interval exercise
      which is characterized by periods of vigorous exercise alternated by periods of moderate
      exercise. Typical interval training sessions require significantly less time to complete than
      traditional modes of exercise wherein moderate intensity activity is sustained for some time.
      This may be especially beneficial to those with type 2 diabetes, as lack of time is a
      frequently cited reason for not engaging in regular exercise. Bodyweight circuit training
      carries the potential to similarly improve health and metabolic function in persons with type
      2 diabetes, and may do so with even a smaller accumulation of exercise because this type of
      exercise involves a greater percentage of the trainee's muscle mass compared with common
      forms of interval training (e.g., treadmill or cycle exercise). The purpose of this study is
      to quantify the effects of 3-4 sessions per week of bodyweight circuit training sustained for
      5-10 minutes per session on health-related physical fitness and glucose tolerance/control in
      people with type 2 diabetes.
    


Intervention name(s): High Intensity Body-weight Circuit Training (HIBC)
Intervention type(s): Behavioral
Intervention description(s): HIBC Exercise Protocol- The HIBC circuit repetition and order is as follows: modified squats (10 repetitions), modified rows (5 repetitions), crunches (10 repetitions), and modified push-ups (5 repetitions). The exercise sessions involved repeating a series of repetitions of each movement in sequence, and completing as many sequences as possible in good form in the time allotted for the exercise (initially, 5 minutes). Participants were instructed to complete three sessions per week and documented the number of cycles completed. After 3 weeks of consistent training, participants were asked to add a 4th session each week as tolerated. Initially, the HIBC sessions were 5 minutes long, and the duration of the sessions were increased by one minute each week as tolerated beginning in week four, peaking at 10-minutes per session as early as the eighth week of training. Session duration was capped at 10 minutes.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Eleven Years of Menicon Z Night Contact Lens Wear in Reducing Myopia Progression in Children
Condition: Myopia, Progressive; Children, Only
MeSH terms: Myopia; Myopia, Degenerative
Study type: Interventional

Summary: 
      To compare axial length growth of white European myopic children wearing Menicon Z Night
      orthokeratology contact lenses to a control group of distance, single-vision glasses and
      contact lenses over an 11-year period.
    

Detailed description: 
      This prospective, controlled, parallel, longitudinal study compared the axial length growth
      of white European myopic children wearing Menicon Z Night orthokeratology contact lenses to a
      control group of distance, single-vision glasses and or distance, single-vision soft contact
      lenses over an 11-year period.
    

Intervention name(s): Menicon Z Night; Control
Intervention type(s): Device; Device
Intervention description(s): Menicon Z Night orthokeratology contact lenses were used to assess their efficacy in reducing myopia progression in children; Distance, single-vision glasses were used as a control
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: Prospective, controlled, parallel, longitudinal
Masking: None (Open Label)
Primary purpose: Treatment