bioihbjkbjnl/mcl2 huggingface dataset:
Sinus Lift With Newly Forming Bone and Inorganic Bovine Bone
Condition: Maxillary Sinus
Study type: Interventional

Summary: 
      The aim of this study is to evaluate the efficacy of newly forming bone graft (NFB) in the
      gain of bone volume in sinus lift procedures. For that, it will be compared the tomographic
      bone gain 6 months after surgery between a group that received inorganic bovine bone alone
      (n=8) and a group that received inorganic bovine bone associated with NFB (n=8).
    

Detailed description: 
      The aim of this study is to evaluate the efficacy of newly forming bone graft (NFB) in the
      gain of bone volume in sinus lift procedures. It will be recruited for this study individuals
      25-60 years of age, both genders, presenting a missing tooth at an upper premolar or molar
      region with 2-9 mm of remaining bone between alveolar ridge crest and sinus floor and the
      existence of an edentulous ridge or at least one tooth condemned to extraction. Sinus will be
      treated by NFB mixed to inorganic bovine bone - IBB (test; n= 8) or IBB (control; n= 8). The
      volume of bone tissue will be evaluated by computerized tomography obtained at baseline
      examination and 6 months after surgery. After this period, biopsies of hard tissue will be
      obtained during implant placement for histologic and histomorphometric analysis.
    

Intervention name(s): Sinus lift; Surgical alveolus; Inorganic bovine bone + newly forming bone; Inorganic bovine bone; Collagen membrane
Intervention type(s): Procedure; Procedure; Procedure; Procedure; Device
Intervention description(s): Using a lateral access, the Schneider membrane will be elevated using curettes allowing the insertion of graft material.; Using a round diamond bur, a surgical alveolus will be created on an toothless ridge region.; Maxillary sinus lift will be done with inorganic bovine bone associated with newly forming bone. The newly forming bone will be collected from surgical alveolus previous prepared.; Maxillary sinus lift will be done with inorganic bovine bone.; At the end of the sinus lift, a collagen membrane will be used to obliterate the graft inside the maxillary sinus.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Maxillary Sinus; Sinus lifting; Bone graft
Blood Flow Stimulation in the Lower Limbs by Application of Different External Devices
Condition: Venous Stasis; Deep Vein Thrombosis
MeSH terms: Thrombosis; Venous Thrombosis; Varicose Ulcer
Study type: Interventional

Summary: 
      In this study, four different devices which stimulate the blood in the lower extremities are
      used in ten healthy persons while measuring the blood flow with ultrasound. The aim is to
      study the haemodynamic effects in the lower extremities of each modality and also to compare
      those effects between the four modalities in order to identify those which most effective
      than the others.
    

Detailed description: 
      Three Intermittent Pneumatic Compression (IPC) devices were selected: Foot-IPC, rapid
      Calf-IPC and a slow, sequential Calf-IPC. A Neuromuscular Electrical Stimulation (NMES)
      device was also used in the calf. Blood flow measurements in the right popliteal vein of ten
      healthy individuals were performed using Doppler ultrasound before (control) and while using
      IPC or NMES. The blood flow parameters measured where: peak systolic velocity (cm/s),
      time-averaged mean velocity (cm/sec), volume flow (ml/min) and ejected volume per individual
      stimulus (ml). The tolerability of each device was also assessed using an analogue scale from
      zero to ten. Differences between modalities regarding the pattern as well as the absolute
      values of velocity and volume are being assessed. Power calculation: Recent studies showed
      that the peak venous velocity (PV) at baseline is around 11 cm/s and after applying foot-IPC
      the PV rises to 50 cm/s with a maximum standard deviation of 15 (Broderick et all, 2014).
      Thus, three patients per group would be required to detect a difference of 39 cm/s in PV
      (two-sided type-I error rate = 5%; power = 80%). To reach an even higher power we choose to
      include 10 patients in study, which resulted in a power of 99.7% for the above calculation.
    

Intervention name(s): Foot IPC; Rapid calf IPC; Slow calf IPC; Calf NMES
Intervention type(s): Device; Device; Device; Device
Intervention description(s): Intermittent pneumatic compression in the foot using the A-V Impulse™, Covidien®, New Haven, CT, USA; Intermittent pneumatic compression in the calf using the VenaFlow® Elite, DJO Global, USA; Intermittent pneumatic compression in the calf using the Kendall SCD™ 700, Covidien, Medtronic, USA; Neuromuscular electrical stimulation in the calf using the DJOTM, CefarCompex Mi-Theta 500 stimulator
Other intervention name(s): Intermittent pneumatic compression in the foot; Rapid Intermittent pneumatic compression in the calf; Slow Intermittent pneumatic compression in the calf; Calf neuromuscular electrical stimulation
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Intermittent Pneumatic Compression Devices; Electric Stimulation Therapy; Blood Flow Velocity; Hemodynamics
Anti-Tumor Necrosis Factor (TNF) Treatments, Work Productivity and Quality of Life in Crohn's Disease
Condition: Crohn's Disease
MeSH terms: Crohn Disease
Study type: Observational

Summary: 
      This multicenter, prospective, post marketing observational study (PMOS) was designed to
      demonstrate long-term effects of anti-Tumor Necrosis Factor therapies on Work Productivity
      and Impairment scales in participants with moderate to severe Crohn's Disease (CD) under
      routine conditions. Secondary objectives of this study were long-term improvement of Quality
      of Life (QoL), evaluation of improvement of extraintestinal symptoms and comorbidities, and
      evaluation of safety.
    

Detailed description: 
      Male or female participants between 18 - 65 years of age with moderate to severe CD for whom
      the treating physician had recently initiated an anti-TNF treatment were included in this
      study. Anti-TNF treatments were administered according to the treating physician's decision
      and applicable product label in Turkey. No interventions were made to the treatment and the
      participant discontinuance or to the follow-up decisions of the treating physician. Enrolled
      participants were observed for one year.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Participants with Crohn's Disease who at the time of study entry were receiving anti-Tumor
        Necrosis Factor treatment as prescribed in accordance with Turkish Ministry of Health
        regulations and reimbursement conditions
      
Keywords: Crohn's Disease
ALT-801 in Diabetic and Non-Diabetic Overweight and Obese Subjects With Non-alcoholic Fatty Liver Disease (NAFLD)
Condition: Non-Alcoholic Fatty Liver Disease
MeSH terms: Liver Diseases; Fatty Liver; Non-alcoholic Fatty Liver Disease; Overweight
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of the study is to assess the safety and tolerability of ALT-801 in diabetic and
      non-diabetic subjects with overweight and obese and non-alcoholic fatty liver disease
      (NAFLD).
    

Detailed description: 
      This is a Phase 1, multicenter, randomized, double-blind, placebo-controlled study to assess
      the effects of ALT-801 the safety of ALT-801and effects on hepatic fat fraction,
      anthropometric parameters, lipid metabolism, inflammatory markers and fibrosis markers in
      diabetic and non-diabetic overweight and obese (BMI 28.0-45.0 kg/m2) subjects with NAFLD.
    

Intervention name(s): ALT-801; Placebo
Intervention type(s): Drug; Other
Intervention description(s): Injected subcutaneously (SC); Injected subcutaneously (SC)
Other intervention name(s): Pemvidutide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Obese; Overweight
Early-onset Obesity and Cognitive Impairment in Children With Pseudohypoparathyroidism
Condition: Pseudohypoparathyroidism; Albright Hereditary Osteodystrophy
MeSH terms: Pseudohypoparathyroidism; Pseudopseudohypoparathyroidism; Obesity; Cognitive Dysfunction
Study type: Observational

Summary: 
      Pseudohypoparathyroidism type 1a (PHP1a) is a rare disease that causes childhood obesity and
      learning difficulties. This study will investigate eating behaviors and perform cognitive
      testing on children with PHP1a. The investigators will compare their results to those of
      healthy siblings and other obese children.
    

Detailed description: 
      Pseudohypoparathyroidism type 1a (PHP1a) is a genetic disorder that causes early-onset,
      syndromic obesity and cognitive impairment. This study aims to evaluate eating behaviors,
      cognition and executive function in children with PHP1a, compared with healthy siblings and
      matched obese controls.
    

Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Children with pseudohypoparathyroidism type 1a (PHP1a), their healthy siblings and matched
        obese controls
      
Keywords: Pediatric obesity; pseudohypoparathyroidism; Albright Hereditary Osteodystrophy
Fractional Microplasma Radiofrequency Technology for Non-hypertrophic Post-burn Scars in Asians: A Prospective Study of 95 Patients
Condition: Cicatrix
MeSH terms: Cicatrix
Study type: Interventional

Summary: 
      A prospective study to evaluate the efficacy and safety of FMRT for treating non-hypertrophic
      post-burn scars in an Asian population.
    

Detailed description: 
      Background: Laser therapy is an emerging, minimally invasive treatment for scars. Among the
      various techniques, fractional microplasma radiofrequency technology (FMRT) has proved to be
      effective for various types of scars and skin conditions such as rhytids, striae distensae,
      and hyperpigmentation.

      Method: A prospective clinical trial was conducted to evaluate the efficacy and safety of
      FMRT for treating non-hypertrophic post-burn scars in an Asian population. All patients
      underwent three to five treatment sessions at intervals of 8-16 weeks. The patient and
      observer scar assessment scales (POSAS) were use to evaluate changes in the burn scars before
      and after treatment. Intermediate and long-term adverse events were recorded for outcome
      analysis.
    

Intervention name(s): Fractional micro-plasma radiofrequency treatment
Intervention type(s): Procedure
Intervention description(s): After the patient's scars were subjected to a mild cleanser and 70% alcohol, a topical cream of 5% lidocaine hydrochloric acid (Beijing Ziguang Medication Manufacture Corporation Ltd, Beijing, China) was applied to the entire scar surface under occlusion for 60-90 min before treatment to achieve local anesthesia. Fractional micro-plasma radiofrequency treatment (Pixel RF, Accent XL; Alma Lasers, Caesarea, Israel) was applied using a roller tip at 50-80 watts. Three or four passes were made in different directions over each affected area. A high rolling speed of roughly 5 cm/s was manually controlled. This treatment was accompanied by an air cooler (Cryo 5; Zimmer, Warsaw, IN, USA) for pain control. All patients attended three to five treatment sessions at intervals of 8-16 weeks.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Burn Scar; Micro-plasma Radiofrequency Therapy
A Study to Assess Pharmacokinetic, Pharmacodynamic, Safety and Tolerability of ASKP1240 in de Novo Kidney Transplantation
Condition: Kidney Transplantation
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of the study is to assess the Pharmacokinetics (PK),

      pharmacodynamics (PD), safety and tolerability of ASKP1240 when administered to subjects who
      received a de novo kidney transplant.
    


Intervention name(s): bleselumab; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Intravenous (IV) infusion; Intravenous (IV) infusion
Other intervention name(s): ASKP1240
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Pharmacology; Pharmacokinetics; ASKP1240; Kidney Transplantation
Thoracic Epidural Analgesia and Bilateral Erector Spinae Plane Block on Postoperative Pain in Open Heart Surgeries
Condition: Pain, Postoperative; Respiratory Complication
MeSH terms: Pain, Postoperative
Study type: Interventional

Summary: 
      Postoperative pain negatively effects respiratory functions in open heart surgeries. The aim
      of the study is to compare the effects of thoracic epidural analgesia (TEA) and erector
      spinae plane block (ESPB) on postoperative pain and respiratory functions in patients
      undergoing open heart surgery with sternotomy
    

Detailed description: 
      Thoracic epidural catheter was inserted to patients in Group T at the T4-T5 vertebra level
      before induction of general anesthesia. And then local anesthetic infusion was started until
      postoperative 48. hours.

      Bilateral erector spinae plan block was applied with total 40 ml of local anesthetic solution
      to patients in Group E at the T4-T5 vertebra level before induction of general anesthesia.

      The control group was infused with 1 mcg/kg/min fentanyl during the surgery. In the
      postoperative period, 1 g paracetamol was infused 4 times a day.

      All patients underwent general anesthesia with the same method and medications.

      Tramadol/diclofenac was administered to patients with a pain score (NRS) above 4. NRS and
      tidal volumes (TV) of the patients were measured at 0, 2, 6, 12, 24, 36 and 48. hours after
      extubation. Postoperative mechanical ventilation durations, intensive care unit and hospital
      stays, additional analgesic needs and respiratory complications of the patients were
      recorded.
    

Intervention name(s): Thoracic epidural analgesia; Erector spinae plane block
Intervention type(s): Procedure; Procedure
Intervention description(s): Thoracic epidural analgesia was started preoperatively and rest posoperative 48 hours; Erector spinae plane block was applied preoperatively using local anesthetic
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: The effects of thoracic epidural analgesia and erector spinae plane block on postoperative pain were compared with the control group.
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Thoracic epidural analgesia; erector spinae plane block; heart surgery
the Bispebjerg Study of Diurnal Variations
Condition: Diurnal
Study type: Interventional

Summary: 
      To evaluate the influence of time of day on the circulating concentrations of various
      biochemical markers in healthy men
    


Intervention name(s): Diurnal variation
Intervention type(s): Other
Intervention description(s): Venous blood samples were obtained under standardized circumstances from 24 healthy young men every third hour through 24 hours, nine time points in total.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Functional Rehabilitation of Upper Limb Apraxia in Patients Poststroke
Condition: Stroke; Apraxias
MeSH terms: Apraxias
Study type: Interventional

Summary: 
      The purpose of this study is to analyze the effects of a mixed intervention of occupational
      therapy (rehabilitative and compensatory approach) at home to upper limb apraxia in mild and
      moderate patients post stroke in comparison to a control group with a traditional health
      educative protocol.
    

Detailed description: 
      Apraxia is a neurological disorder characterized by a loss of ability to execute and carry
      out skilled movements and gestures despite intact motor and sensory systems, coordination and
      comprehension.

      Upper limb apraxia comprises a wide spectrum of higher motor disorders caused by acquired
      brain disease, affecting the performance of skilled movements carried out by the upper limbs.

      Few data are available on the effectiveness of interventions in this disorder and no exists
      studies that implement a mixed intervention (rehabilitative and compensatory ) of
      Occupational Therapy in these patients at home.
    

Intervention name(s): Functional Rehabilitation of apraxia; Traditional health educative protocol
Intervention type(s): Other; Other
Intervention description(s): The intervention will cover every type of approaches related with upper limb apraxia.
We will use different kinds of tools to activate cerebral networks implied on apraxia, for facilitating the cerebral neuroplasticity in the recovering of the patient.
On the other hand, when the function can not be improved, we will provide skills and strategies for enhance the environment adaptation and increasing the autonomy and independence.; The traditional health educative protocol consist in an educational workshop for patients and caregivers where they are taught the implications of apraxia in their daily live, kind of errors of apraxia for gaining consciousness of the syndrome, and some strategies to facilitate the adaptation of the patient in her house.
Other intervention name(s): Intervention of occupational therapy in apraxia; Traditional intervention in apraxia
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: MeSH terms:; Apraxias; Apraxia, Ideomotor; Stroke; Cerebral Stroke; Rehabilitation; Occupational therapy; Treatment Outcome; Activities of Daily Living
Effect of Footwear on the Clinical, Functional, and Biomechanical Aspects in Elderly Women With Knee Osteoarthritis (OA)
Condition: Knee Osteoarthritis
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine whether inexpensive, flexible and non-heeled
      footwear is effective in improving of clinical, functional and gait biomechanics in elderly
      women with knee osteoarthritis.
    

Detailed description: 
      -  The clinical and functional aspects will be evaluated using a visual analogue scale
           (VAS) for pain, Western Ontario and McMaster Universities (WOMAC) and Lequesne
           questionnaires of quality of life in patients with knee osteoarthritis and testing of
           six-minute walk (6MWT).

        -  Biomechanical analysis of gait will be performed by infrared cameras and a force
           platform. From the data of kinematics and kinetics, will be calculated moments of the
           knee joint strength by inverse dynamics.

      The process (steps) will be divided as follows:

        -  step 1, in this step there will be sorting and initial assessment of potential
           participants; pain will be evaluated through VAS, function and quality of life by means
           of questionnaires WOMAC and Lequesne and the 6MWT, and by evaluating the biomechanics of
           gait.

        -  step 2,(3 month follow-up), both groups will be evaluated again by the VAS and WOMAC and
           Lequesne questionnaires.

        -  step 3, after 6 months of starting the monitoring process, both groups will be
           reevaluated through the VAS, WOMAC, Lequesne, 6MWT and biomechanical analysis of gait.
           This step is the final evaluation, characterizing the end of intervention.
    

Intervention name(s): Flexible footwear
Intervention type(s): Other
Intervention description(s): The patients of the Intervention Group (IG) will be use over 6 month a flexible and non-heeled footwear (Moleca; Calçados Beira Rio S.A., Novo Hamburgo, Rio Grande do Sul, Brazil) is a women's flexible flat walking shoe, without heels, with an anti-slip rubber sole, 5-mm thin, with a 3 mm internal wedge of ethylene vinyl acetate, made out of dubbed canvas. It had a mean weight of 172 ± 19.6 g, ranging from 142 to 193 g depending upon the size.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: Knee osteoarthritis; Shoes; Gait; Biomechanics
Efficacy of Adding Interpersonal and Emotional Processing Therapy Techniques to Cognitive Behavioral Therapy to Treat Generalized Anxiety Disorder
Condition: Generalized Anxiety Disorder
MeSH terms: Anxiety Disorders
Study type: Interventional

Summary: 
      This study will test a version of cognitive behavioral therapy for generalized anxiety
      disorders that incorporates interpersonal and emotional processing techniques.
    

Detailed description: 
      Generalized anxiety disorder (GAD) is characterized by chronic worry that interrupts normal
      functioning. Some research has shown cognitive behavioral therapy (CBT) to be an effective
      treatment for GAD, but only half of people treated with CBT for GAD experience treatment
      benefits long-term. Standard CBT for GAD may lose effectiveness over time because it does not
      address interpersonal and emotional processing problems. This study will determine the
      efficacy of a version of CBT with additional therapeutic techniques for addressing
      interpersonal interactions and emotional processing among adults with GAD.

      Participation in this study will include 14 weeks of treatment and 2 years of follow-up
      visits. All participants will receive 14 weekly, 2-hour, individual therapy sessions and one
      maintenance session scheduled after completing treatment. During the first hour of each
      session, all participants will receive standard CBT. Participants will be randomly assigned
      to receive one of two therapies during the second hour: training in interpersonal and
      emotional processing techniques or listening therapy. Participants may continue taking their
      current medications if they maintain a fixed dosage and keep a daily dairy of medication use,
      starting 2 weeks before study entry and lasting throughout treatment.

      In-depth study assessments will take place at baseline and after completing the 14 weeks of
      therapy. Assessments will include clinical interviews, self-report questionnaires, and a
      physiological measurement session. Questions will pertain to anxiety symptoms,
      self-perceptions, emotional experience, and perceptions of the world. The physiological
      measurement session will involve recording bodily reactions, including brain waves, heart
      rate, eye movement, and breathing, while performing simple perceptual tasks. Brief
      psychological assessments will also follow each therapy session. Follow-up assessments
      conducted 6, 12, and 24 months after completing treatment will involve interviews and
      questionnaires as well as recording a week's worth of medication diaries.
    

Intervention name(s): CBT; Interpersonal and emotional processing therapy; supportive listening
Intervention type(s): Behavioral; Other; Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: CBT; GAD; Interpersonal Therapy; Emotion-Focused Therapy