bioihbjkbjnl/mcl2 huggingface dataset:
Efficacy and Safety of Intravenous Ferric Carboxymaltose in Pediatric Patients With Iron Deficiency Anemia and Unsatisfactory Response Oral Iron Under Study Protocol 1VIT17044
Condition: Iron Deficiency Anemia
MeSH terms: Anemia; Anemia, Iron-Deficiency; Iron Deficiencies; Deficiency Diseases
Study type: Interventional
Phase: Phase 3

Summary: 
      Evaluating the Efficacy and Safety of Intravenous Ferric Carboxymaltose in Pediatric Patients
      with Iron Deficiency Anemia and an Unsatisfactory Response to Oral Iron under Study Protocol
      1VIT17044
    

Detailed description: 
      This is a single arm, open-label, multi-center, multi-national, non-randomized study that
      will evaluate the efficacy and safety of a one course treatment with FCM in participants who
      had an unsatisfactory response to oral iron in study 1VIT17044.

      Subjects will have an End of Study (EOS) Visit (Day 35) from the 1VIT17044 study to qualify
      for entry. Subjects will then be screened, meet all inclusion criteria, no exclusion criteria
      and have a baseline evaluation. Based on the successful completion of the baseline
      evaluations, subjects will be enrolled and will receive the first dose of FCM (Day 0). The
      second FCM dose will occur 7 days from the first dose. Subjects will return to the clinic 14
      and 28 days post their first dose for laboratory and safety assessments, and at 35 days post
      the first dose, participants will return to the clinic for final safety and efficacy
      assessments. Once all assessments are complete the participant will exit the study.

      An unsatisfactory response to oral iron (i.e., an increase in hemoglobin (Hgb) of <1 g/dL
      from baseline) will be defined as non-responders to oral iron treatment. Non-responders who
      continue to meet all inclusion criteria (including Hgb <11 g/dL) and none of the exclusion
      criteria will receive 1 course of FCM.
    

Intervention name(s): Ferric carboxymaltose
Intervention type(s): Drug
Intervention description(s): IV iron
Intervention model: Single Group Assignment
Intervention model description: This is a single arm, open-label, multi-center, multi-national, non-randomized study that will evaluate the efficacy and safety of a one course treatment with FCM in participants who had an unsatisfactory response to oral iron in study 1VIT17044.
Masking: None (Open Label)
Primary purpose: Treatment
eHealth Evidence-based Intervention (EBI) for Latino Youth in Primary Care
Condition: Sexual Risk Behavior; Drug Use; Family Functioning
Study type: Interventional

Summary: 
      The purpose of this study is to test the relative effectiveness of a Hispanic-specific
      eHealth intervention, "e-Health Familias Unidas," in preventing and reducing drug use, sexual
      risk behaviors, and STIs among Hispanic youth in primary care. Families will be recruited
      through four pediatric primary care settings. Pediatric staff and research team members,
      including nurse assistants and mental health professionals, will implement eHealth Familias
      Unidas.
    


Intervention name(s): eHealth Familias Unidas Primary Care
Intervention type(s): Behavioral
Intervention description(s): The experimental condition will consist of "eHealth Familias Unidas Primary Care." eHealth Familias Unidas Primary Care is an adaptation of the face-to-face version of Familias Unidas. As with face-to-face Familias Unidas, eHealth Familias Unidas Primary Care aims to prevent drug use, sexual risk behaviors, and STIs by improving family functioning. Similar to face-to-face Familias Unidas, eHealth Familias Unidas is a multi-level intervention that targets risk and protective factors at the multiple systems affecting the youth and youths' family.
Other intervention name(s): eHealth Familias Unidas
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Prevention with Hispanic youth; eHealth preventive intervention in primary care; Hispanic adolescent; Familias Unidas; eHealth Familias Unidas; effectiveness trial; sexually transmitted disease; parent-centered; Hispanic; sexual risk behavior
Psychology and Physiotherapy Approach of Chronic Pain in Patients With Hemophilia
Condition: Haemophilia
MeSH terms: Hemophilia A; Chronic Pain
Study type: Interventional

Summary: 
      This study evaluates the clinical impact of a combined protocol with cognitive-behavioral
      intervention and physiotherapy adjuvant to the standard medical treatment in patients with
      haemophilia that suffer from chronic pain
    

Detailed description: 
      The purpose of this study is to improve the perception of the experience of chronic pain, as
      well as functionality and quality of life in hemophilic patients with chronic pain

      Secondary objectives are:

        -  to change the perception that the patient has of their pain, to improve the coping
           strategies and to increase the perception of self-efficacy of patients in pain
           management.

        -  to increase the resources that allow a better self-regulatory of emotional, cognitive
           and competential of the pain experience, reverting in the emotional state of patients,
           particularly in levels of anxiety and depression.

        -  to improve functional capacity and musculoskeletal status.

        -  to improve quality of life.

        -  to determine whether changes / improvements are maintained over time 3 months after
           finishing the program
    

Intervention name(s): Psychology and Physiotherapy group; Placebo comparator: control group
Intervention type(s): Other; Other
Intervention description(s): Psychological program: 4 sessions,2 hours each,4 months
Psychoeducation.Influence of psychological factors on chronic pain: modulators of pain experience. Biopsychosocial model of pain.
Training techniques of psychological management of pain:Diaphragmatic Breathing and Progressive Muscle Relaxation to control vicious circle pain-tension-pain.
Kinesiophobia. Rational regulation of the activity level:Cognitive therapy (management of irrational believes about pain) and Organisation of time and reinforcement activities.
Physiotherapy program:3 sessions per week,1 hour per session,4 months:
Aerobic exercise:walking, cycling
Warm-up: active ROM exercises of inferior and superior extremities (ISE)
Progressive resistance training with elastic bands of ISE
Stretching of ISE; Control group Normal daily activities Usual daily activities
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Study to Assess the Efficacy and Safety of Tizaspray® Versus Sirdalud®, in Patients With Acute Low Back Pain
Condition: Low Back Pain
MeSH terms: Back Pain; Low Back Pain
Study type: Interventional
Phase: Phase 3

Summary: 
      Open label, randomized, controlled, multicenter study with two parallel groups of patients
    

Detailed description: 
      This is a phase III, open label, randomized, controlled, multicenter study with two parallel
      groups of patients.

      Tizaspray® 0.5 mg (a new pharmaceutical form, liquid nasal spray solution), is proposed in
      this trial as a ready to use treatment for short term therapy of painful muscle spasms as the
      acute low back pain.
    

Intervention name(s): Tizaspray® administered intranasally; Sirdalud® 2 mg tablets administered
Intervention type(s): Device; Drug
Intervention description(s): 0,5 mg Tizaspray® administered intranasally; Sirdalud® 2 mg tablets administered in patients with acute low back pain
Other intervention name(s): Tizaspray®; Sirdalud®
Intervention MeSH terms: Tizanidine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Acute low back pain
Vitamin C & Thiamine to Treat Sepsis and Septic Shock
Condition: Sepsis; Septic Shock
MeSH terms: Sepsis; Toxemia; Shock, Septic; Shock
Study type: Interventional
Phase: Phase 2

Summary: 
      Investigators propose to investigate the use of IV vitamins B1 and C in a randomized,
      double-blinded, prospective trial to determine if these medications decrease mortality rates
      in patients with severe sepsis or septic shock.
    

Detailed description: 
      Investigators propose to investigate the use of IV vitamins B1 and C in a randomized,
      double-blinded, prospective trial to determine if these medications decrease mortality rates
      in patients with severe sepsis or septic shock. Patients experiencing evidence-based
      diagnoses of sepsis and severe sepsis and septic shock will be randomized to the two study
      arms for care, and all other care left to decisions of intensive care teams.
    

Intervention name(s): Vitamin C; Vitamin B1
Intervention type(s): Drug; Drug
Intervention description(s): Patients will receive 1.5g of vitamin C in 100mL of 0.9% sodium chloride (normal saline) every six hours for four days or until discharge from the ICU, whichever happens first (seventeen dose maximum).; Patients will also receive 200 mg of IV vitamin B1 every 12 hours in 50 mL of normal saline for four days or until ICU discharge (whichever happens first, nine dose maximum).
Other intervention name(s): Ascorbic Acid; Thiamine
Intervention MeSH terms: Vitamins; Ascorbic Acid; Thiamine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Sepsis; Septic Shock; Vitamin C; Thiamine
Ketamine for Endoscopic Sedation in Outpatient Adult Endoscopy.
Condition: Administration and Dosage of Ketamine; Endoscopic Sedation
Study type: Interventional
Phase: Phase 2

Summary: 
      We will be investigating the use of ketamine in sedation for endoscopic procedures,
      specifically outpatient endoscopy including esophagoduodenoscopy (EGD) and colonoscopy.
      Participants will be randomized to one of two arms including conventional moderate sedation
      with midazolam and fentanyl or the ketamine arm. They will then undergo the planned
      procedure. Physicians preforming the procedure will be surveyed following the procedure and
      patients will be surveyed twice, once after meeting criteria for discharge on day of the
      procedure and a second time 48 hours following the procedure.
    

Detailed description: 
      In this study, the investigators plan to conduct a single blinded randomized controlled trial
      in the Gastroenterology Service to demonstrate the efficacy of ketamine and its utility in
      moderate sedation. Patients presenting to the endoscopy lab for esophagogastroduodenoscopy
      (EGD) and/or colonoscopy who meet inclusion criteria will be approached, and if amenable,
      will be consented and enrolled. Patients will be randomized to receive either a ketamine
      loading dose and then subsequent doses IV ketamine and midazolam 1mg IV prior to
      administration of ketamine or standard fentanyl/midazolam moderate sedation during their
      procedure. Participants will then undergo the planned procedure. The primary outcome will be
      patient satisfaction, which will be measured using the validated "Patient Satisfaction with
      Sedation" instrument (PSSI). A number of secondary outcomes will include the following: (1)
      provider satisfaction (measured using and the "Clinician Satisfaction with Sedation"
      instrument (CSSI), (2) the time from sedation administration to procedure start (when the
      scope is inserted), (3) the time from sedation to recovery (defined as the time from the end
      of the procedure until the patient meets discharge criteria from the recovery area), (4) time
      to cecum (for colonoscopy) total doses of medications given (midazolam, fentanyl, and
      ketamine), (5) overall time of the procedure, (6) adverse events, (7) changes in vital signs,
      (8) and the need for additional medications, in particular reversal agents.
    

Intervention name(s): Ketamine; Midazolam injection; Fentanyl
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Experimental arm for sedation.; Part of standard sedation regimen and anxiolysis and for minimization of emergence reaction; Part of standard sedation regimen
Intervention MeSH terms: Midazolam; Fentanyl; Ketamine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Treatment Efficacy for Drug Abuse and AIDS Prevention - 2
Condition: Cocaine-Related Disorders; Heroin Dependence
MeSH terms: Substance-Related Disorders; Cocaine-Related Disorders; Heroin Dependence
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to assess the safety and effectiveness of buprenorphine for
      treatment of concurrent intravenous heroin and cocaine dependence.
    


Intervention name(s): Buprenorphine
Intervention type(s): Drug
Intervention MeSH terms: Buprenorphine
Primary purpose: Treatment
A Study of Seltorexant Compared to Quetiapine XR as Adjunctive Therapy to Antidepressants in Adult and Elderly Participants With Major Depressive Disorder With Insomnia Symptoms Who Have Responded Inadequately to Antidepressant Therapy
Condition: Depressive Disorder, Major
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to assess the efficacy of seltorexant compared with quetiapine
      extended-release (XR) as adjunctive therapy to an antidepressant drug in treatment response
      in participants with major depressive disorder with insomnia symptoms (MDDIS) who have had an
      inadequate response to current antidepressant therapy with a selective serotonin reuptake
      inhibitor (SSRI) or serotonin-norepinephrine reuptake inhibitor (SNRI).
    

Detailed description: 
      Major depressive disorder (MDD) is a common, serious, recurrent disorder. Seltorexant
      (JNJ-42847922) is a potent and selective antagonist of the human orexin-2 receptor (OX2R)
      that is being developed for the adjunctive treatment of MDDIS. The hypothesis for this study
      is that seltorexant is superior to quetiapine XR in leading to a response after 26 weeks of
      treatment (greater than or equal to [>=] 50 percent [%] improvement on baseline Montgomery
      Asberg Depression Rating Scale [MADRS] total score), when administered as adjunctive
      treatment to an antidepressant in adult and elderly participants with MDDIS who have had an
      inadequate response to treatment with an SSRI/SNRI. The study will be conducted in 3 phases:
      a screening phase (up to 30 days), a double-blind (DB) treatment phase (26 weeks), and a post
      treatment follow-up phase (7 to 14 days after the end of DB treatment phase for all
      participants, and up to 196 days from baseline for participants who stop study treatment
      early). The total study duration for each participant will be approximately 32 weeks.
      Efficacy, safety, pharmacokinetics, and biomarkers will be assessed at specified time points
      during this study.
    

Intervention name(s): Seltorexant; Matching placebo to Seltorexant; Quetiapine XR; Matching placebo to Quetiapine XR
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Participants will receive seltorexant over-encapsulated tablet orally.; Participants will receive placebo over-encapsulated tablet matching to seltorexant orally.; Participants will receive quetiapine XR capsule orally.; Participants will receive placebo capsule matching to quetiapine XR orally.
Intervention MeSH terms: Quetiapine Fumarate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
A Study to Evaluate the Efficacy and Safety of Lumacaftor in Combination With Ivacaftor in Subjects With CF, Homozygous for the F508del-CFTR Mutation
Condition: Cystic Fibrosis
MeSH terms: Cystic Fibrosis; Fibrosis
Study type: Interventional
Phase: Phase 3

Summary: 
      To evaluate the efficacy and safety of lumacaftor in combination with ivacaftor in subjects
      aged 6 Through 11 years with cystic fibrosis (CF), homozygous for the F508del CF
      transmembrane conductance regulator (CFTR) mutation
    


Intervention name(s): VX-809; Placebo; VX-770
Intervention type(s): Drug; Drug; Drug
Other intervention name(s): lumacaftor; ivacaftor
Intervention MeSH terms: Ivacaftor
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
A Comparison of Estradiol Vaginal Cream to Estrace® Cream in 350 Postmenopausal Females With Atrophic Vaginitis
Condition: Atrophic Vaginitis
MeSH terms: Vaginitis; Atrophic Vaginitis; Atrophy
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to determine the therapeutic equivalence of Mylan's estradiol
      vaginal cream to Estrace® cream and superiority of both products to placebo. The protocol
      describes a randomized, double-blind, multi-dose, placebo-controlled, parallel study of a 7
      day treatment.
    


Intervention name(s): Estradiol Vaginal Cream, 0.01%; Estrace® 0.01% cream; Placebo Vaginal Cream
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Estradiol Vaginal Cream, 0.01% (1 x 2g for 7 days); Estrace® 0.01% vaginal cream ( 1 x 2g for 7 days); Placebo Vaginal Cream ( 1 x 2 g for 7 days)
Intervention MeSH terms: Estradiol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: vaginal dryness; vaginal and/or vulvar irritation/itching; dysuria; vaginal pain and bleeding associated with sexual activity; vaginal atrophy
Propofol Versus Propofol-Fentanyl as Sedation For Lumbar Puncture in Children With Acute Leukemia/Lymphoma
Condition: Leukemia; Lymphoma
MeSH terms: Lymphoma; Leukemia
Study type: Interventional

Summary: 
      The hypothesis of the study is that propofol-fentanyl sedation for lumbar punctures in
      children with acute leukemia/lymphoma results in fewer adverse events than propofol sedation
      alone. Secondary hypotheses state that propofol-fentanyl sedation results in a better
      sedation induction, recovery profile and is preferred by patients/families. The study is a
      double blind, randomized, placebo controlled crossover study. Following the induction phase
      of chemotherapy, children will be randomized in a crossover manner to receive either
      fentanyl-propofol or propofol-placebo for future lumbar punctures. Patients will be studied
      on two separate occasions, once with propofol-placebo (normal saline) and once with
      propofol-fentanyl. Children will be monitored continuously by pulse oximetry,
      electrocardiogram (ECG) and direct nursing and physician observation during the sedation in
      accordance with the University of Wisconsin (UW) Pediatric Policy and Procedure. Propofol
      will be titrated to a Children's Hospital of Eastern Ontario Pain Scale (CHEOPS) score of ≤ 7
      for all children. Oxygen saturation, respiratory rate, heart rate and blood pressure will be
      recorded every 3 minutes by a study investigator during sedation.
    


Intervention name(s): Propofol-Fentanyl; Propofol alone
Intervention type(s): Drug; Drug
Intervention MeSH terms: Fentanyl; Propofol
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double
Primary purpose: Treatment
Keywords: pediatric; acute leukemia/lymphoma
Cytoflavin in the Treatment of Patients With Diabetic Polyneuropathy
Condition: Diabetic Neuropathies
MeSH terms: Diabetic Neuropathies; Polyneuropathies
Study type: Interventional
Phase: Phase 3

Summary: 
      One of the most common complications of diabetes mellitus is diabetic polyneuropathy, which
      leads to disability and reduces quality of life. The toxic effects of high glucose
      concentrations contribute to the formation of ketoaldehyde free radicals, which, at an
      increased rate of their formation, leads to the development of oxidative stress in the
      nervous tissue. The planned study of the use of Cytoflavin® in diabetic polyneuropathy is
      substantiated by its antioxidant effect, which, by analogy with alpha-lipoic acid
      preparations, suggests its efficacy in the combined treatment of such patients. This clinical
      study is being conducted to assess the efficacy and safety of Cytoflavin® versus Placebo in
      diabetic polyneuropathy patients with type 2 diabetes. Study patients will receive study
      medication, 10 IV infusions followed by 75 days of oral intake. Clinical efficacy will be
      assessed by alleviation of symptoms (burning, numbness, pain and pricking), using the total
      symptoms score(TSS), after the completion of the treatment course.
    


Intervention name(s): Cytoflavin (Inosine + Nicotinamide + Riboflavin + Succinic Acid); Placebo
Intervention type(s): Drug; Drug
Intervention description(s): The study drug will be administered in two phases: intravenous infusion of study drug for 10 days followed by oral administration of study drug for 75 days. Thus, the total duration of the study therapy is 12 weeks.; The placebo comparator will be administered in two phases: intravenous infusion of placebo solution for 10 days followed by oral administration of placebo pills for 75 days. Thus, the total duration of the study therapy is 12 weeks.
Intervention MeSH terms: Niacinamide; Niacin; Nicotinic Acids; Riboflavin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment
Keywords: Diabetes Mellitus; Peripheral Nervous System Diseases; Antioxidants; Succinic acid
Peri-operative Oral Triiodothyronine Replacement Therapy to Decrease the Risk of Transient Atrial Fibrillation After Off-pump Coronary Artery Bypass Surgery
Condition: Non-thyroidal Illness Syndrome
MeSH terms: Atrial Fibrillation; Euthyroid Sick Syndromes
Study type: Interventional

Summary: 
      This study is planned to medicate oral T3(Liothyronine)to the patients who are planned to
      have OPCAB(off- pump coronary bypass graft surgery. The aim of this study was to assess the
      effects of oral triiodothyronine (T3) therapy on postoperative thyroid hormone
      concentrations, hemodynamic variables and outcomes in patients undergoing OPCAB in a
      randomized, controlled trial.
    


Intervention name(s): liothyronine sodium; placebo
Intervention type(s): Drug; Drug
Intervention description(s): liothyronine sodium 20ug, every 12hour (before anesthetic induction, total 4 times); vitamin B12
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Supportive Care