bioihbjkbjnl/mcl2 huggingface dataset:
Efficacy and Safety of Infliximab Biosimilar in the Treatment of Resistant Hidradenitis Suppurativa
Condition: Hidradenitis Suppurativa
MeSH terms: Hidradenitis Suppurativa; Hidradenitis
Study type: Interventional
Phase: Early Phase 1

Summary: 
      The aim of this clinical trial is to assess the efficacy and safety of Infliximab-dyyb
      biosimilar in patients of resistant Hidradenitis suppurativa. The main question it aims to
      answer are:

        -  how effective is infliximab biosimilar in treating resistant Hidradentis suppurativa

        -  Is infliximab biosimilar safe in these patients Patients will receive weekly injections
           of Infliximab Biosimilar Remsima, according to weight, for first 4 weeks, and then
           fortnightly for next 24 weeks. Patients will be followed up at 4, 14 and 24 weeks for
           assessment of safety and efficacy
    

Detailed description: 
      The aim of this clinical trial is to assess the efficacy and safety of Infliximab-dyyb
      biosimilar in patients of resistant Hidradenitis suppurativa. The main question it aims to
      answer are:

        -  how effective is infliximab biosimilar in treating resistant Hidradentis suppurativa

        -  Is infliximab biosimilar safe in these patients Patients will receive weekly injections
           of Infliximab Biosimilar Remsima, according to weight, for first 4 weeks, and then
           fortnightly for next 24 weeks. Patients will be followed up at 4, 14 and 24 weeks for
           assessment of safety and efficacy.

      Pre and post treatment HiSCR, IHS4, DLQI scores and photos will be taken for comparison at
      week 0, 4, 14 and 24. Details will be entered on predesigned proforma DATA ANALYSIS
      PROCEDURE: Data will be entered and analyzed using SPSS 20. Data will be stratified for role
      of effect modifiers.
    

Intervention name(s): Infliximab-dyyb biosimilar
Intervention type(s): Biological
Intervention description(s): Remsima for subcutaneous injection is a biosimilar monoclonal antibody of infliximab-dyyb that inhibits the activity of tumour necrosis factor (TNF)-alpha.
Other intervention name(s): Remsima (infliximab-dyyb biosimilar)
Intervention MeSH terms: Infliximab
Intervention model: Single Group Assignment
Intervention model description: Adult patients of either gender suffering from Hidradenitis suppurativa resistant to conventional therapies
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Hidradenitis suppurativa; Infliximab biosimilar; Efficacy; safety
Bispectral Index Value Changes During Induction and Surgical Decompression in Head Injury Patients
Condition: Traumatic Brain Injury
MeSH terms: Brain Injuries; Brain Injuries, Traumatic; Craniocerebral Trauma; Wounds and Injuries
Study type: Interventional
Phase: Phase 4

Summary: 
      This study was conducted in two parts:

        1. This first part was designed to determine thiopentone dose requirement for induction of
           anaesthesia with and without the use of Bispectral Index monitoring - Participant and
           Care Provider in appropriate study arm blinded.

        2. As a secondary outcome, Bispectral index monitoring was used to observe changes in
           neuronal function in intraoperative period as well as haemodynamic changes
           intraoperatively - Participant and Care Provider blinded.
    

Detailed description: 
      Surgery for traumatic brain injury is an anaesthetic challenge fraught with complications
      such as brain bulge, excessive bleeding, hypotension etc. As yet there are no anaesthetic
      regimen guidelines to follow for induction of anaesthesia in neurotrauma surgeries. Although
      the functional effect of anaesthetic agents on neuronal tissue is known quite well, there is
      lack of studies documenting the effect of these anaesthetic agents on head injured patients.
      It is also not known whether the requirement of anaesthetic agent in the same as a non head
      injured patient. This study was designed to assess the requirement of anaesthetic thiopentone
      in head injured patients and compare the anaesthetic usage with and without Bispectral index
      (BIS) monitoring. We also observed the real time change in neuronal function using Bispectral
      Index monitoring after craniotomy, i.e. effectively decompression and release of intracranial
      pressure intraoperatively.
    

Intervention name(s): Bispectral Index
Intervention type(s): Device
Intervention description(s): Thiopentone was administered in 50 mg boluses during induction of anaesthesia, until reduction of Bispectral Index value to less than 50, and total dose of thiopentone recorded.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Inj. Thiopentone dose requirement for induction of anaesthesia with and without the use of Bispectral Index guidance.
Observation of Bispectral Index change in intraoperative period.
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment
Keywords: Bispectral Index
Peripheral Arterial Insufficiency Associated With HIV/AIDS
Condition: Arterial Insufficiency; Acquired Immunodeficiency Syndrome; HIV
MeSH terms: Acquired Immunodeficiency Syndrome; HIV Infections; Immunologic Deficiency Syndromes
Study type: Observational [Patient Registry]

Summary: 
      The purpose of this study is to determine the risk factors associated with the occurrence of
      arterial insufficiency in patients with HIV / AIDS, and to identify the prevalence of this
      disease. The estimated prevalence is 10%, similar to that reported in the general population.
    

Detailed description: 
      A case study nested in a cohort of patients with HIV / AIDS at Instituto Nacional de Ciencias
      Médicas y Nutrición Salvador Zubirán, Mexico, with a cohort of 1500 patients , a sample size
      of 206 individuals was calculated. Data collection was performed in a prospective cross
      shape.

      During the interview, written informed consent for inclusion in the study, along with a
      standard query of vascular surgery in which the patient's history as well as cardiovascular
      risk factors. Also, a vascular physical examination including palpation of pulses in upper
      and lower extremities (brachial, radial, ulnar, femoral, popliteal, posterior tibial and
      dorsalis pedis), femoral murmurs search and determining ankle / brachial indexes with a
      standardized method.

      In determining the ABI was counted with a Doppler ultrasound 8 mHz, transducer gel and a
      sleeve for manual measurement of blood pressure, 20% longer than the largest diameter of the
      arm circumference.

      If the patient is diagnosed with, symptomatic or asymptomatic arterial insufficiency, ABI
      measurements were performed at rest and effort, plus pressure index finger-arm or
      plethysmography. Patients with altered rates were followed in vascular surgery care.

      The data were recorded in a single database unique protected by password. The results were
      analyzed using the statistical program STATA v 9.0.
    

Intervention name(s): Ankle-Brachial index
Intervention type(s): Procedure
Intervention description(s): The only procedure to be performed is the measurement of ABI for the diagnosis of arterial insufficiency.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        The 206 patients will be randomly selected from the cohort HIV / AIDS INCMNSZ, which have
        confirmed diagnosis of the disease and wish to participate in the study, without a disease
        that put life in imminent danger.
      
Keywords: Arterial Insufficiency; Human Immunodeficiency Virus; Atherosclerosis; Ankle-brachial index; HAART
Evaluation of Immune Response Against the Strain of Neisseria Meningitidis B: 14, P1-7, 16 in Patients Having to be Vaccinated MenBVac® (Extension EFFIVAC)
Condition: Neisseria Meningitidis
Study type: Observational

Summary: 
      The main objective of the study is to estimate the proportion of children, born between the
      06/04/2004 and the 17/004/2008, living around Neufchatel en Bray, vaccinated by MenBVac, with
      a serum bactericidal activity against B:14,P1-7,16 clone related to a protection (>= 4),
      before the fourth dose of MenBvac and after: 6 weeks and one year after the fourth dose.
    


Intervention name(s): MenBvac
Intervention type(s): Biological
Intervention description(s): Blood test
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Children aged 4 to 8 years old and living in neufchatel en bray area
      
Keywords: Neisseria meningitidis B:14, P1-7, 16; Serum bactericidal activity; OMV vaccine
MRI Study - Chronic Progressive External Ophthalmoplegia
Condition: Chronic Progressive External Ophthalmoplegia
MeSH terms: Ophthalmoplegia, Chronic Progressive External; Ophthalmoplegia
Study type: Observational

Summary: 
      The purpose of this study is to investigate the fraction of fat on a MRI scan of lower bag
      muscles, thighs and calves in patients with the mitochondrial disease chronic progressive
      external ophthalmoplegia (CPEO).

      Additionally an investigation of the volume of the eye muscles will be done and compared to
      the patient's clinical presentation of ptosis and ophthalmoplegia.
    

Detailed description: 
      The lack of energy and fatigue seen in patients with mitochondrial diseases have been assumed
      to be caused by an energy defect because of a genetic defect in the mitochondrial DNA.

      The investigators have analyzed a few MRI scans of muscles from patients with CPEO and have
      seen an extended amount of fat in their muscles, which seems to progress with age. The
      patient's symptoms might be caused by the extended amount of fat and thereby a less amount of
      active muscle instead of the "energy defect".

      This will be investigated in a group of patients with CPEO and the results will be compared
      with results from a group of healthy controls.
    

Intervention name(s): Magnetic Resonance Imaging
Intervention type(s): Other
Intervention description(s): MRI of eye muscles, lower bag muscles, thigh muscles and calf muscles.
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Danish patients with verified single large-scale mtDNA deletions and chronic progressive
        external ophthalmoplegia.
Testing an Online Insomnia Intervention
Condition: Alcohol Use Disorder; Insomnia
MeSH terms: Sleep Initiation and Maintenance Disorders; Alcoholism
Study type: Interventional

Summary: 
      The objective of this trial is to determine the effectiveness of an electronic cognitive
      behavioral therapy for insomnia (e-CBT-I) module in improving sleep and reducing alcohol use
      among heavy drinkers with insomnia. Specifically, it will test the effectiveness of Sleep
      Healthy Using the Internet (SHUTi), a well-validated version of e-CBT-I comprised of 6 weekly
      educational modules and daily sleep diaries. The rationale for this mixed methods proposal is
      that effective, nonpharmacologic treatments are necessary to stem the highly comorbid public
      health problems of alcohol use disorder (AUD) and insomnia. If successful, SHUTi will
      represent a novel and easily accessible intervention for reducing alcohol intake among
      high-risk heavy drinkers.
    


Intervention name(s): Web-Based Insomnia Education Program; SHUTi Intervention
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Participants will be given access to a web-based program on sleep education to read at their own pace during the 9-week intervention period. The program content overlaps with SHUTi on the following topics: insomnia symptoms, impacts, and causes, basic sleep improvement strategies, and when to see a doctor. The information is akin to that found on WebMD or National Sleep Foundation website. Unlike the SHUTi program, the information is fixed, accessible immediately (no week-to-week information "unlocking") and there are no customized bedtime or wake-time suggestions based on sleep diary data.; Sleep Healthy Using the Internet (SHUTi) is a well-validated version of e-CBT-I comprised of 6 weekly educational modules and daily sleep diaries. Participants will have 9 weeks to complete 6 once-weekly educational "cores." Cores consist of: insomnia overview, sleep restriction, stimulus control, cognitive restructuring, sleep hygiene, and relapse prevention, and last approximately 45 minutes each. Participants will receive weekly objectives, as well as review and feedback on the previous core's assignments and sleep diary data, new material, assignments, and a summary. These features are supplemented with interactive features (i.e., personalized goal-setting, video vignettes). Participants receive daily emails prompting them to complete the 11-item sleep and alcohol use diary daily during the intervention.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: sleep; cognitive behavioral therapy; CBT; electronic; alcohol; non-pharmacological
ReCoUPS: Post-Concussion Patient Reports
Condition: Brain Concussion; Head Injury
MeSH terms: Craniocerebral Trauma; Brain Concussion
Study type: Interventional

Summary: 
      Physical and cognitive rest are recommended as treatment for concussion, but debate persists
      about the utility of this recommendation for patients recovering from concussion. In
      addition, patient adherence to physical and cognitive rest recommendations after concussion
      remains unknown. This study will measure and compare symptom and activity reports in the days
      and weeks after a concussion among patients randomly assigned to different incentive-based
      arms.
    

Detailed description: 
      Although physical and cognitive rest are recommended as the hallmark treatment for
      concussion, debate persists about the utility of this recommendation for patients recovering
      from a concussion. In addition, patient adherence to physical and cognitive rest
      recommendations after concussion remains unknown. Objective and timely measures of physical
      and cognitive activity will aid in defining the relationship between physical and cognitive
      rest and clinical outcomes, such as symptom status, in the days and weeks after a concussion.
      Random assignment to incentive-based arms will be used to measure patient engagement with the
      study protocol and a dedicated research platform that involves ecological momentary
      assessment (EMA), in which participants report their real-time symptoms and daily activities
      in response to randomly timed prompts, will be used to help assess the rest and recovery
      process among pediatric and adult patients after concussion.
    

Intervention name(s): Streak incentive; Loss-based incentive; Flat-fee control status quo condition; Flat-Fitbit control status quo condition
Intervention type(s): Behavioral; Behavioral; Behavioral; Behavioral
Intervention description(s): Participants will receive prompts 3 times a day for 21 days prompting them to complete surveys. They will start with a $0 balance and will earn a fixed amount for each response.; Participants will receive prompts 3 times a day for 21 days prompting them to complete surveys. They will start with the maximum balance and will lose a fixed amount for each response they do not complete.; Participants will receive prompts 3 times a day for 21 days prompting them to complete surveys. They will receive the maximum compensation at the end of the study.; Participants will receive prompts 3 times a day for 21 days prompting them to complete surveys. They will keep the Fitbit at the end of the study.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Camrelizumab Combined With Apatinib for Recurrent Resistant GTN
Condition: Gestational Trophoblastic Disease
MeSH terms: Gestational Trophoblastic Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      This study is to evaluate the efficacy and safety of camrelizumab plus apatinib in patients
      with high-risk chemo-refractory or relapsed GTN.
    

Detailed description: 
      Apatinib is an oral small-molecule tyrosine kinase inhibitor that selectively binds to and
      inhibits VEGF receptor 2. Novel immunotherapy using the immune checkpoint inhibitors such as
      anti-PD-1 antibody has received much attention. Camrelizumab as one of the anti-PD-1 drug
      have impressive clinical activity.
    

Intervention name(s): Apatinib; Camrelizumab
Intervention type(s): Drug; Drug
Intervention description(s): 250mg, po, qd; 200mg, q2w
Intervention MeSH terms: Apatinib
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: camrelizumab; apatinib; gestational trophoblastic neoplasia; high-risk; chemo-refractory; relapse
Investigation of Faldaprevir Effect on Pharmacokinetics of Raltegravir
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective of this trial is to investigate effect of faldaprevir on steady state
      pharmacokinetics of raltegravir.

      The assessment of safety and tolerability will be an additional objective of this trial.
    


Intervention name(s): Raltegravir; Raltegravir; Faldaprevir
Intervention type(s): Drug; Drug; Drug
Intervention description(s): low dose oral administration; low dose oral administration; medium dose oral administration
Intervention MeSH terms: Raltegravir Potassium
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Bioequivalence Study of Two Olaparib Tablets in Patients With Cancers
Condition: Neoplasms
Study type: Interventional

Summary: 
      This study aimed to evaluate the pharmacokinetic characteristics and bioequivalence of two
      olaparib tablets in patients with epithelial ovarian, fallopian tube, or primary peritoneal
      cancer.
    


Intervention name(s): The test olaparib tablet (T); The reference olaparib tablet (R)
Intervention type(s): Drug; Drug
Intervention description(s): The test olaparib tablet (Qilu Pharmaceutical Co., Ltd., Jinan, China) 300mg, every 12 hours; The reference olaparib tablet (Lynparza®; AstraZeneca PLC, Cambridge, England, UK) 300mg, every 12 hours
Intervention MeSH terms: Olaparib
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Bipolar Versus Monopolar Resection of Benign Prostate Hyperplasia
Condition: Acute Hyponatremia
MeSH terms: Prostatic Hyperplasia; Hyponatremia; Hyperplasia
Study type: Interventional

Summary: 
      Aim of this prospective clinical study was to compare two different surgical techniques and
      used solutions on serum electrolytes, bleeding and Transurethral Resection of Prostate (TURP)
      syndrome undergoing TURP.

      Fifty-three patients scheduled for elective TURP were enrolled in this prospective clinical
      study. Patients were included one of two groups (Group Monopolar and Group Bipolar).
    

Detailed description: 
      Background and Purpose:

      Aim of this prospective clinical study was to compare two different surgical techniques and
      used solutions on serum electrolytes, bleeding and Transurethral Resection of Prostate (TURP)
      syndrome undergoing TURP.

      Methods:

      Fifty-three patients scheduled for elective TURP were enrolled in this prospective clinical
      study. Patients were divided into two groups. Patients in Group M (Monopolar) (n=25) were
      used monopolar resectoscope (Karl Storz, Tottling, Germany) and 5% mannitol as irrigating
      solution. Patients in Group B (Bipolar) (n=25) were used bipolar resectoscope TURis (OLYMPUS,
      Tokyo, Japan) and isotonic saline as irrigating solution. Patients who received spinal
      anaesthesia were given 2.5-3 ml 0.5% hyperbaric bupivacain intrathecally and others were
      given general anaesthesia. Patients demographics, prostate volumes, hemodynamic parameters,
      volumes of irrigation and IV solutions were recorded. Blood samples were collected
      preoperatively (control), 45 minutes after the induction (2nd Measurement) and 1 hour after
      the end of the operation for analyzing serum electrolytes, osmolarity, hemoglobin values.
    

Intervention name(s): 5% Mannitol; 0,9% Sodium chloride; monopolar resectoscope; bipolar resectoscope TURis
Intervention type(s): Other; Other; Device; Device
Intervention description(s): Traditional monopolar TURP was performed by using and irrigation fluid containing 5% mannitol ( Resectisol Eczacibasi-Baxter).; Bipolar TURP was carried out by using a 24 Fr TURis (OLYMPUS) resectoscope and irrigation fluid containing 0,9 % sodium chloride.
Other intervention name(s): Karl Storz resectoscope; TURis (OLYMPUS) resectoscope
Intervention MeSH terms: Mannitol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Monopolar; Bipolar; TURP syndrome; hyponatremia
A Phase 3, Long-term Safety and Tolerability Study of ALKS 3831 in Adults With Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 3

Summary: 
      The primary objective of this study is to evaluate the long-term safety and tolerability of
      ALKS 3831 in subjects with schizophrenia.
    


Intervention name(s): ALKS 3831
Intervention type(s): Drug
Intervention description(s): Coated bilayer tablet containing 10 mg, 15 mg or 20 mg olanzapine and 10 mg samidorphan
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Alkermes; ALKS 3831; Samidorphan; Schizophrenia; Safety
12-Week Placebo-controlled Study of Atogepant for the Preventive Treatment of Migraine in Participants With Episodic Migraine
Condition: Episodic Migraine
MeSH terms: Migraine Disorders
Study type: Interventional
Phase: Phase 3

Summary: 
      To evaluate the safety and tolerability of atogepant 30 mg and 60 mg once a day for the
      prevention of migraine in participants with episodic migraine.
    


Intervention name(s): Atogepant; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Atogepant tablet; Placebo-matching atogepant tablets
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: Migraine; Aura