bioihbjkbjnl/mcl2 huggingface dataset:
Low Frequency Electrical Stimulation of the Fornix in Intractable Mesial Temporal Lobe Epilepsy (MTLE)
Condition: Mesial Temporal Lobe Epilepsy
MeSH terms: Epilepsy; Epilepsy, Temporal Lobe
Study type: Interventional

Summary: 
      The primary aim of the current proposal is to evaluate safety and tolerability, in terms of
      neuropsychological effects of low frequency electrical stimulation of the fornix (LFSF) in
      participants with medically-intractable Mesial Temporal Lobe Epilepsy. Secondary aims include
      evaluation of psychiatric changes, seizure frequency, and quality of life during LFSF.
    

Detailed description: 
      Low frequency stimulation is an attractive, uninvestigated method for treatment of
      intractable epilepsy. Preliminary animal and human data suggest safety and remarkable
      efficacy of Low frequency stimulation (LFS) in epilepsy. In addition, the duty cycle of LFS
      is very low, implying less electric current injection, with less charge density on the target
      tissue and electrodes, and longer battery life. The current project is a classic
      translational, single-blinded, randomized research project, demonstrating a clear path from
      the laboratory to bedside. If successful, this new therapy will be of great value to patients
      with medically and surgically intractable Mesial Temporal Lobe Epilepsy (MTLE).

      The study is expected to last approximately 5 years, from enrollment of the first patient to
      completion of the final subject, taking into consideration attrition and otherwise-eligible
      subjects who will not elect to participate. Once the study is completed, and enrolled
      participants have completed all required elements of the protocol, a final report will be
      submitted to the FDA. Participants may also discontinue their participation in the study, if
      they wish, at any time.
    

Intervention name(s): Medtronic Deep Brain Stimulation
Intervention type(s): Device
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Perioperative Temperature Management
Condition: Hypothermia
MeSH terms: Hypothermia
Study type: Interventional

Summary: 
      The investigators aim to investigate the effects of prewarming of patients undergoing
      elective orthopedic surgery on intraoperative temperature control and blood loss and
      postoperative patient discomfort and glucose and insulin levels.
    

Detailed description: 
      Hypothermia, defined as a core temperature below 36 degrees celsius, is commonly seen in
      patients undergoing surgery. Intraoperative hypothermia is related to postoperative patient
      discomfort, impaired wound healing, increased blood loss, anxiety and disturbances in glucose
      and insulin levels. Prewarming of patients prior to surgery may result in maintenance of
      intraoperative temperature and reduce postoperative complications. We therefore aim to
      investigate the effects of prewarming of patients undergoing elective orthopedic surgery on
      intraoperative temperature control and blood loss and postoperative patient discomfort and
      glucose and insulin levels.

      Objective of the study:

      Does preoperative heating of patients undergoing elective orthopedic surgery reduce the
      incidence of intraoperative hypothermia and postoperative comfort and modulate postoperative
      glucose and insulin blood levels?

      Study design:

      Multi-center, prospective, randomized clinical trial.

      Study population:

      Patients undergoing an elective orthopedic hip- or knee replacement
    

Intervention name(s): Intraoperative warming (Bair Hugger); Pre- and intraoperative warming (HotDog); Intraoperative warming (HotDog)
Intervention type(s): Device; Device; Device
Intervention description(s): Intraoperative warming; Pre- and intraoperative warming by HotDog; Intraoperative warming
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Surgery; Anesthesia; Hypothermia; Temperature; Perioperative; Temperature Management
Radiographic and Clinical Comparison of Post-reduction Splinting Constructs in the Treatment of Acute Displaced Distal Radius Fractures
Condition: Radius Fractures
MeSH terms: Fractures, Bone; Radius Fractures; Wrist Fractures
Study type: Interventional

Summary: 
      Subjects with acute, displaced distal radius fractures will be randomized at the time of
      emergency room evaluation to one of two commonly accepted splinting methods for displaced
      distal radius fractures: sugar tong splints or volar/dorsal clam shell splints. Reduction
      will be performed in the usual, standard fashion and the selected splint applied. Standard
      radiographic measurements of alignment, including radial height, volar tilt and inclination
      will be measured on pre- and post- reduction radiographs by a single reviewer- who will be
      blinded to splint application type. At the first fracture follow-up visit, typically
      occurring between 5-10 days, as in standard practice, repeat radiographs of the wrist will be
      taken, and the same reviewer will measure alignment. As a secondary outcome, patients will
      also complete the disabilities of the arm, shoulder and hand (DASH) questionnaire at this
      visit, to compare patients' ability to perform activities of daily living with their
      respective splints.
    


Intervention name(s): Sugar Tong Splint; Clam Shell Splint
Intervention type(s): Other; Other
Intervention description(s): A splint made of 8-10 layers of plaster rolled into a single long sheet which begins at the distal volar crease of the hand and traverses around the elbow and stops at the dorsal metacarpal heads. The skin is protected with cotton cast padding (webril) and the splint is held in place with ace bandages; A 2-part splint made of 8-10 layers of plaster. The piece traverses from the distal volar crease of the hand to the volar aspect of the proximal forearm. The second piece runs along the dorsal aspect of forearm from metacarpal heads to proximal forearm. The elbow is left free. In the same fashion as the sugar tong splint, the skin is protected with cotton cast padding (webril) and held in place with ace wrap
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: acute, displaced distal radius fracture
Forced-dose Titration of SPD489 in Adults With Binge Eating Disorder
Condition: Binge Eating Disorder
MeSH terms: Bulimia; Feeding and Eating Disorders; Binge-Eating Disorder
Study type: Interventional
Phase: Phase 2

Summary: 
      To evaluate the efficacy of SPD489 compared to placebo in the treatment of moderate to severe
      binge eating disorder as measured by the number of binge days per week
    


Intervention name(s): lisdexamfetamine dimesylate (SPD489); lisdexamfetamine dimesylate (SPD489); lisdexamfetamine dimesylate (SPD489); Placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): SPD489-30mg capsules taken once daily for up to 11 weeks; SPD489 50mg capsules taken once-daily for up to 11 weeks; SPD489 70mg capsule taken once-daily for up to 11 weeks; Placebo capsule taken once daily for up to 11 weeks
Other intervention name(s): LDX, Vyvanse; LDX, Vyvanse; LDX, Vyvanse
Intervention MeSH terms: Lisdexamfetamine Dimesylate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Hydroxychloroquine, Capecitabine, Oxaliplatin, and Bevacizumab in Treating Patients With Metastatic Colorectal Cancer
Condition: Colorectal Cancer
MeSH terms: Colorectal Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      RATIONALE: Drugs used in chemotherapy, such as capecitabine and oxaliplatin, work in
      different ways to stop the growth of tumor cells, either by killing the cells or by stopping
      them from dividing. Monoclonal antibodies, such as bevacizumab, can block tumor growth in
      different ways. Some block the ability of tumor cells to grow and spread. Others find tumor
      cells and help kill them or carry tumor-killing substances to them. Bevacizumab may also stop
      the growth of tumor cells by blocking blood flow to the tumor. Hydroxychloroquine may help
      chemotherapy and bevacizumab work better and kill more tumor cells.

      PURPOSE: This phase II trial is studying how well giving hydroxychloroquine together with
      capecitabine, oxaliplatin, and bevacizumab works in treating patients with metastatic
      colorectal cancer.
    

Detailed description: 
      OBJECTIVES:

      Primary

        -  To assess the progression-free survival (PFS) of patients with metastatic colorectal
           carcinoma treated with hydroxychloroquine in combination with capecitabine, oxaliplatin,
           and bevacizumab and to compare this to a previously reported median PFS of 7.9 months.

      Secondary

        -  To measure the overall response rate.

        -  To measure the duration of response for responding patients.

        -  To measure the disease-control rate (complete response, partial response, or stable
           disease for at least 2 courses).

        -  To document the safety and feasibility of this regimen in these patients.

        -  To develop surrogate biomarkers for autophagy detection in patient tissue specimens and
           to characterize the effects of hydroxychloroquine on autophagy in patients in vivo.

      OUTLINE: This is a multicenter study.

      Patients receive bevacizumab IV over 30-90 minutes and oxaliplatin IV over 2 hours on day 1.
      Patients also receive oral capecitabine twice daily on days 1-15 and oral hydroxychloroquine
      twice daily on days 1-21. Courses repeat every 21 days in the absence of disease progression
      or unacceptable toxicity.

      Peripheral blood and tumor tissue samples may be collected for biomarker and other laboratory
      studies.

      After completion of study treatment, patients are followed up for 1 year.
    

Intervention name(s): hydroxychloroquine
Intervention type(s): Drug
Intervention description(s): hydroxychloroquine 200 mg po BID daily
Intervention MeSH terms: Hydroxychloroquine
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: stage IV colon cancer; stage IV rectal cancer; recurrent colon cancer; recurrent rectal cancer
Short-term Impact of COVID-19 Lockdown on Metabolic Control of Type 2 Diabetes
Condition: Type 2 Diabetes; Metabolic Control
MeSH terms: COVID-19; Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Observational

Summary: 
      The strict rules applied in Italy during the recent COVID-19 pandemic, with the prohibition
      to attend any regular outdoor activity, are likely to influence the degree of metabolic
      control of patients with type 2 diabetes. The aim of this observational, prospective, single
      centre study was to evaluate the immediate impact of the lockdown rules on the metabolic
      profile of a cohort of patients with type 2 diabetes.
    

Detailed description: 
      All the patients with type 2 diabetes who were previously scheduled for a follow-up visit in
      our outpatient diabetes clinic during the lockdown for COVID-19 (March 9, 2020-May 04, 2020)
      were contacted by phone. Patients who accepted to take part of the study received a medical
      prescription for routine analysis via email. They were asked to perform blood drawing one
      week after the end of the lockdown period and transmitted us the results.

      We then compared the metabolic profile tested one week after the end of the lockdown with the
      last value and the mean of the last three determinations performed before the pandemic
      emergency.
    

Intervention name(s): antidiabetic treatment
Intervention type(s): Other
Intervention description(s): Every kind of antidiabetic treatment, oral or injective, were considered including patients treated only with diet
Intervention MeSH terms: Hypoglycemic Agents
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        All the patients with type 2 diabetes, regularly referring (with at least two previous
        clinical records in the last two years) to the outpatient diabetes clinic of Internal
        Medicine section, University Hospital in Pisa, and who were previously scheduled for a
        follow-up visit during the lockdown for COVID-19 (March 9, 2020-May 04, 2020) were screened
        for this observational study.
      
Keywords: T2D; Sars-Cov-2; COVID-19 lockdown; metabolic control; sedentary
A Culturally Sensitive Intervention for TBI Caregivers in Latin America
Condition: Traumatic Brain Injury
MeSH terms: Brain Injuries; Brain Injuries, Traumatic
Study type: Interventional

Summary: 
      Traumatic brain injury (TBI) patients in Latin America experience high levels of disability
      and extremely poor functional outcomes, and their informal caregivers play a key role in
      their rehabilitation and care. To improve TBI rehabilitation through stronger informal
      caregiving, the proposed study will develop and evaluate an evidence--based and culturally
      sensitive Transition Assistance Program for informal caregivers of patients with TBI in Latin
      America during the patient's transition from hospital to home. This study will generate
      findings that can provide empirically supported guidance to clinicians regarding the
      provision of culturally tailored rehabilitation services for TBI caregivers in Latin America
      and in the U.S.
    


Intervention name(s): Transition Assistance Program
Intervention type(s): Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Care Provider)
Primary purpose: Supportive Care
Keywords: Brain Injuries; Caregivers; Intervention Studies; Latin America
Bioequivalence Study of Albendazole 400 mg Tablets in Chinese Population
Condition: Helminthiasis
MeSH terms: Helminthiasis
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of the study is to compare the pharmacokinetic profiles of two Albendazole tablet
      formulations manufactured under the different granulation processes in healthy Chinese adult
      males.
    

Detailed description: 
      Due to the product manufacture process change in Albendazole oral formulation from ethanol
      based granulation process to aqua based granulation process, State Food and Drug
      Administration officially requested Tianjin Smith Kline and French Laboratories to carry out
      a Bioequivalence study to demonstrate bioequivalence between the manufacturing processes.
      This trial will be conducted to support the official requirement via the comparison of the
      pharmacokinetic profiles between both the drugs manufactured under the different processes.

      After oral administration, Albendazole is quickly oxidized into its pharmacologically active
      metabolite, Albendazole sulphoxide (ABZ-SO. Due to extensive metabolism and limited
      absorption, plasma concentration of ABZ after oral administration was found to be too low to
      be measured. Thus, this trial will also compare the pharmacokinetic profiles of ABZ-SO
      manufactured using different solvents.
    

Intervention name(s): Albendazole
Intervention type(s): Drug
Intervention description(s): Albendazole tablets 400 mg
Intervention MeSH terms: Albendazole
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Assessment of the Relationship Between Edema Measurement Methods After Impacted Mandibular Third Molar Surgery.
Condition: Impacted Third Molar Tooth
MeSH terms: Tooth, Impacted
Study type: Interventional

Summary: 
      The aim of this study is to evaluate the correlation between two point distance measurements
      performed by surgeon on patients face with foldable ruler, which is the most commonly used
      method, and the subjective scoring will be done by the patient with the help of the edema
      scale, for measuring edema.
    

Detailed description: 
      The patients will be selected among the patients who apply for mandibular impacted third
      molar extraction to Necmettin Erbakan University, Faculty of Dentistry. A total of 60
      patients will be included. All third molar operations will be carried out by the same surgeon
      in all groups with the same technique.Two methods will be used to evaluate the edema on the
      face.

        1. Method The surgeon will measure from three different places on the patient's face ( two
           point distance) with the help of a paper ruler.

             -  Tragus-Pogonion

             -  Tragus-Labial Komissura

             -  Angulus Mandibula-Lateral Kantus Measurements will be made preoperative,
                postoperative 2. and 7. days and saved as milimetre.

        2. Method Patients will be given edema scale.With the help of the edema scale, the patients
           will be evaluated the edema by themselves. When the patient stand in front of the
           mirror, they will be assessed the edema on their face. And a value between 0 and 4 will
           be pointed on the scale postoperative 2. and 7. days.

      A correlation between the results of the first and second methods will be examined.
    

Intervention name(s): Edema measurement methods
Intervention type(s): Other
Intervention description(s): A correlation between the results of the first and second methods will be examined.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: edema; third molar
The Effect of Per Oral Immunotherapy in Severe Milk, Peanut and Egg Allergy in Adults
Condition: Food Allergy
MeSH terms: Hypersensitivity; Food Hypersensitivity; Egg Hypersensitivity
Study type: Interventional

Summary: 
      The aim is to analyse the results of per oral immunotherapy treatment in severe milk, peanut
      or egg allergy in adults. This is the second part of the oral immunotherapy study in adults
      at Skin and Allergy Hospital. The diagnosis of food allergy is verified with positive
      history, skin prick tests, egg and milk allergen specific IgE (immunoglobulin E) antibodies.
      In addition, food allergy is verified with an open label (milk allergy) or blind (peanut and
      egg allergy) allergen specific challenge test. OIT (oral immunotherapy) is performed
      according to a detailed plan. Lung function parameters are followed before OIT and and a year
      after OIT.
    

Detailed description: 
      30 patients with milk allergy (at least 18 year olds), 30 patients with peanut allergy and 30
      patients with egg allergy are treated with OIT. The diagnosis of food allergy is verified
      with positive history, skin prick test, egg and milk allergen specific IgE antibodies. In
      addition, food allergy is verified with an open label (milk allergy) or blind (peanut and egg
      allergy) allergen specific challenge test. Quality of life, anxiety and patient history data
      is collected by questionnaires. All the patients undergo a spirometry with a bronchodilatator
      test, exhaled nitric oxide test and a methacholine challenge before and a year after oral
      immunotherapy. All the patients undergoing oral immunotherapy are prescribed with emergency
      medication such as antihistamine tablets, prednisolon tablets (40mg for three days in
      adults), epinephrine autoinjector (300 µg per dose) and salbutamol or terbutaline inhalator.
    

Intervention name(s): Oral immunotherapy
Intervention type(s): Dietary Supplement
Intervention description(s): Milk, peanut or egg oral immunotherapy
Intervention MeSH terms: Immunomodulating Agents
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: Prospective open label study on oral immunotherapy with either milk, or peanut or egg white food products.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: oral immunotherapy; milk; peanut; egg; adult
Complete Nerve-Sparing Radical Hysterectomy for Cervical Cancer
Condition: Cervical Squamous Cell Carcinoma; Cervical Adenocarcinoma; Malignant Neoplasm of Cervix Stage IB1; Stage IIA1 Cervical Cancer
MeSH terms: Uterine Cervical Neoplasms; Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the feasibility of complete nerve-sparing type C1
      radical hysterectomy in cervical cancer.
    

Detailed description: 
      The primary objective of this study is to evaluate the rate of postvoid residual urine volume
      (PVR) <50ml on postoperative day 4 in patients with stage IB1 and IIA1 cervix cancer
      underwent complete nerve-sparing type C1 radical hysterectomy.
    

Intervention name(s): Nerve-Sparing Radical Hysterectomy
Intervention type(s): Procedure
Intervention description(s): Type C1 NSRH Removal indwelling catheter on day 4 after surgery
Other intervention name(s): Fully Pelvic-Nerve Plexus Preserved
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Cervical cancer; Nerve-sparing hysterectomy; simplified
Efficacy and Safety of Ingavirin®, Syrup, 30 mg/5 ml, in Children With Influenza and Other Acute Respiratory Viral Infections
Condition: Influenza, Human; Acute Respiratory Infection; Common Cold
MeSH terms: Infections; Communicable Diseases; Influenza, Human; Respiratory Tract Infections; Virus Diseases; Common Cold
Study type: Interventional
Phase: Phase 3

Summary: 
      The study is planned to evaluate the therapeutic efficacy and safety of Ingavirin®, syrup, 30
      mg/5 ml, in the treatment of influenza or other acute respiratory infections in children from
      6 months to 2 years compared with placebo.
    


Intervention name(s): Ingavirin®, syrup, 30 mg/5 ml; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): A dose will be based on the body weight; Ingavirin® will be administered once a day on top of standard therapy.; Placebo will be administered once a day on top of standard therapy.
Intervention MeSH terms: Pentanedioic acid imidazolyl ethanamide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment