bioihbjkbjnl/mcl2 huggingface dataset:
To Assess the Safety, Tolerability and Pharmacokinetics of AZD5634 Following Inhaled and Intravenous (IV)Dose Administration
Condition: Cystic Fibrosis
MeSH terms: Cystic Fibrosis
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a Phase 1, first-in-human (FIH) single ascending dose study being conducted to better
      understand the safety, tolerability and pharmacokinetics of AZD5634 in healthy subjects
    

Detailed description: 
      This study is a Phase I, FIH, randomized, single-blinded (study center staff remain blinded
      during the dosing phase of the study), placebo-controlled, single ascending dose, sequential
      dose group study in healthy male subjects and/or female subjects of non-childbearing
      potential at a single study center to assess AZD5634 following inhaled and intravenous dose
      administration
    

Intervention name(s): AZD5634 for inhalation; AZD5634 for infusion; Placebo
Intervention type(s): Drug; Drug; Other
Intervention description(s): Solution, citrate buffer, saline nebulizer solution; strength 0.1 - 5 mg/g; administered by jet nebulizer; Solution, citrate buffer, saline solution for infusion; strength 0.013 mg/mL; inactive substance
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Basic Science
Keywords: inhaled dose; intravenous dose; healthy subjects; safety; tolerability; pharmacokinetics; AZD5634; jet nebulizer
Pharmacokinetics Study of Donepezil HCl in Subjects Receiving Haemodialysis.
Condition: End-Stage Renal Disease
MeSH terms: Kidney Diseases; Kidney Failure, Chronic
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to investigate the pharmacokinetics of donepezil HCl 3 mg in
      subjects with end-state renal disease who were receiving haemodialysis.
    

Detailed description: 
      This is a randomised, single-center, open-label, single-dose, two-period crossover
      pharmacokinetics study of donepezil HCl tablets 3 mg in subjects receiving haemodialysis.
      Subjects will be or will not be receiving haemodialysis. After intervals of over 15 days, the
      subjects will be receiving the other treatment.
    

Intervention name(s): donepezil HCl; donepezil HCl
Intervention type(s): Drug; Drug
Intervention description(s): Subjects will receive donepezil HCL 3 mg without haemodialysis. After an interval of over 15 days, the subjects will receive donepezil 3 mg with haemodialysis.; Subjects will receive donepezil HCl 3 mg with haemodialysis. After an interval of over 15 days, the subjects will receive donepezil 3 mg without haemodialysis.
Intervention MeSH terms: Donepezil
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: end-stage renal disease hemodialysis donepezil hydrochloride pharmacokinetics Cross-Over Study
Neuroinflammation and Modulating Factors in Depression and HIV
Condition: Depression; HIV
MeSH terms: Neuroinflammatory Diseases; Depression; Depressive Disorder
Study type: Interventional
Phase: Phase 2

Summary: 
      Determine if depression, which persists after depression treatment at 26 weeks, is associated
      with increased innate inflammation in a prospective cohort of HIV-infected Ugandans receiving
      SSRIs in which group psychotherapy is initiated.
    

Detailed description: 
      Depression in HIV is a complex co-morbidity with both social factors such as stigma as well
      as biologic components. Disruptions in neurotransmitters such as serotonin and catecholamines
      are known to cause depression. Inflammation caused by diseases such as stroke, diabetes, and
      HIV is associated with higher rates of depression. HIV causes inflammation throughout the
      body, but since the virus can cross the blood-brain-barrier, HIV can replicate in and target
      the brain causing neuroinflammation which predisposes depression. However the pathophysiology
      of the role of inflammation in comorbid depression and HIV is poorly understood.

        1. Among depressed HIV-infected Ugandans, determine if the resolution of depression at 26
           weeks of HIV therapy is improved with group psychotherapy.

        2. In the same population determine if persistent depression is associated with higher
           levels of innate inflammation. Also, compare baseline and follow up inflammation among
           depressed compared to non-depressed control group.

        3. Evaluate if viral suppression levels at 26 weeks are improved by group psychotherapy.
    

Intervention name(s): Group Pyschotherapy; Depression Standard of Care; HIV Standard of Care
Intervention type(s): Behavioral; Other; Other
Intervention description(s): Group psychotherapy; Standard clinical care for depression, which may include the use of selective serotonin re-uptake inhibitors (SSRIs).; Standard clinical care for HIV
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Online Coping Skills Counseling for Problem Gambling and Trauma
Condition: Gambling Disorder; Trauma, Psychological; Problem Gambling; Posttraumatic Stress Disorder
MeSH terms: Wounds and Injuries; Stress Disorders, Post-Traumatic; Gambling; Psychological Trauma
Study type: Interventional

Summary: 
      This randomized controlled trial examines the efficacy of two behavioral therapies. Seeking
      Safety, which addresses co-occurring problem gambling (PG) and posttraumatic stress disorder
      (PTSD), is being compared to Cognitive-Behavioral Therapy for PG, which addresses only PG.
      Both models are delivered via telehealth.
    

Detailed description: 
      Our key study question is whether an integrated focus on PG and PTSD (Seeking Safety; SS)
      offers a useful new option for clinical care compared to a purely problem gambling approach
      (Cognitive-Behavioral Therapy for PG; CBT-PG). This question-the impact of integrated versus
      non-integrated treatment for co-occurring disorders-is one of the key issues in the field
      currently and has never been studied in relation to PG and PTSD.

      Our aims are:

        1. To conduct an RCT of SS versus CBT-PG in a sample of 84 people with current PG and PTSD
           (full or subthreshold).

        2. To evaluate outcomes from baseline to end of treatment and 12 month followup on two
           primary variables (money lost gambling and number of gambling sessions) and several
           secondary variables.

      Our hypotheses are: (a) SS will do no worse than CBT-PG on the primary PG outcomes as both
      treatments are designed to address addiction; i.e., both will show improvement from baseline
      to end of treatment and maintenance of gains through the followup. (b) SS will show superior
      results on trauma symptoms as SS is designed to address those, whereas CBT-PG is not.
    

Intervention name(s): Seeking Safety; CBT for Pathological Gambling
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Seeking Safety (SS) is a present-focused, evidence-based cognitive-behavioral therapy for trauma and/or addiction. It offers safe coping skills and education relevant to both problem areas.; Cognitive Behavior Therapy for Pathological Gambling (CBT-PG) is an evidence-based therapy for gambling problems. It focuses on cognitive correction, problem solving, social skills and relapse prevention.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Robot Therapy in Pediatric Emergency
Condition: Child, Only
MeSH terms: Emergencies
Study type: Observational

Summary: 
      The investigators are evaluating if the use of humanoid robots is an optimal distraction
      strategy in order to produce positive emotional states and facilitate the diagnosis and to
      reduce treatment time in pediatric age in emergency situations.
    


Intervention name(s): Robot; Medical Personnel; Caregiver
Intervention type(s): Other; Other; Other
Intervention description(s): The patient interacts with a robot; The patient interacts with medical personnel; The patient interacts with the caregiver
Observational model: Other
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Children in pediatric emergency department
A Conversion Study of Immediate Release (IR) and Modified Release (MR) Forms of Topiramate (TPM)
Condition: Epilepsy
MeSH terms: Epilepsy
Study type: Interventional
Phase: Phase 1

Summary: 
      This multi-center, two-treatment study compares the pharmacokinetic profiles of Immediate
      Release (IR) and Modified Release (MR) formulations of Topiramate (TPM) in patients with
      epilepsy.
    


Intervention name(s): Topiramate IR; Topiramate ER
Intervention type(s): Drug; Drug
Other intervention name(s): Topamax®; SPN-538T
Intervention MeSH terms: Topiramate
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Benefit of Pharyngeal and Oesophageal pH-impedance of Patients With High Suspicion of Laryngopharyngeal Reflux
Condition: Laryngopharyngeal Reflux; Oesophageal pH-impedance
MeSH terms: Gastroesophageal Reflux; Laryngopharyngeal Reflux
Study type: Interventional

Summary: 
      Laryngopharyngeal reflux (LPR) is the retrograde movement of gastric contents into the
      larynx, pharynx and upper aerodigestive tract. The symptoms and manifestations are very
      changeable and non specific. Pharyngeal and Oesophageal pH-impedance may help to detect these
      reflux and to identify patients with abnormal LPR.

      To compare and describe the results of pharyngeal and oesophageal pH-impedance of patients
      with high suspicion of laryngopharyngeal reflux, with the results of healthy patients.
    

Detailed description: 
      This is a monocentric, prospective descriptive study. Patients will be recruited in
      otolaryngology and gastroenterology departments of Bordeaux teaching hospital. A first
      clinical, endoscopic and pH-impedance evaluation will be made, after at least 15 days of
      interruption of any proton pump inhibitors (PPI). After 8 weeks' treatment by double PPI
      doses (esomeprazole 40 mg bid), another clinical and pH-impedance evaluation will be
      realized. The characteristics of the patients who respond to the treatment will be compared
      to non responders. The subjects will also have an initial laryngoscopy, an oesophageal
      manometry allowing the location of the lower sphincter of the oesophagus and the upper
      sphincter of the oesophagus for positioning the catheters.
    

Intervention name(s): esomeprazole
Intervention type(s): Drug
Intervention description(s): Patients with pharyngolaryngeal symptoms will have a clinical evaluation, laryngoscopy, and pharyngoesophageal pH-impedance. Then a treatment by esomeprazole during 8 weeks in the term of which the second clinical evaluation and pH-impedance will be made.
Intervention MeSH terms: Esomeprazole
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Stability of the Knee Joint After Anterior Cruciate Ligament and Anterolateral Ligament Reconstruction
Condition: Cruciate Ligament Rupture
MeSH terms: Rupture
Study type: Interventional

Summary: 
      The objective of this randomised cohort study was to evaluate the knee rotational stability
      after the single-bundle ACL reconstruction (SB) with addition of the ALL reconstruction and
      to compare it with the double-bundle ACL reconstruction technique (DB) and to analyse when
      the ALL is necessary to reconstruct.
    

Detailed description: 
      Background Rotational instability after the anterior cruciate ligament (ACL) injury and
      subsequent reconstruction may be caused by the rupture of the anterolateral structures of the
      knee, specifically the anterolateral ligament (ALL).

      There are more techniques to improve the rotational stability of the knee. The objective of
      this randomised cohort study was: (1) To evaluate the knee rotational stability after the
      single-bundle ACL reconstruction (SB) with addition of the ALL reconstruction and to compare
      it with the double-bundle ACL reconstruction technique (DB). (2) To analyse when the ALL is
      necessary to reconstruct.

      Methods 60 patients underwent the ACL reconstruction with the average age of 29.5 years. In
      thirty patient's knees the ACL was replaced with quadriceps muscle graft using the SB
      technique in combination with the ALL reconstruction by the gracilis graft (ALL group). With
      another thirty patients the ACL was reconstructed performing DB technique with the use of
      hamstring tendons (DB group). The rotational stability was studied before and after the
      reconstruction of the ACL in time "zero" using the computer navigation system. In the ALL
      group, the rotational stability was also analysed after the ALL reconstruction.
    

Intervention name(s): reconstruction of the ACL and anterolateral ligament
Intervention type(s): Procedure
Intervention description(s): reconstruction of the ACL and anterolateral ligament
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Laryngeal Injuries After Removal of the Tracheal Tube: A Comparison Between Sevoflurane and Propofol
Condition: Vocal Cord; Injury, Superficial
MeSH terms: Wounds and Injuries
Study type: Interventional

Summary: 
      Vocal cord injuries occur not only during tracheal intubation, but also during surgery and
      during removal of tracheal tube. Volatile anesthetics increase neuromuscular block of muscle
      relaxants. Thus, the investigators tested the hypothesis, that sevoflurane would cause less
      vocal cord injuries than a total intravenous anesthesia with propofol.
    

Detailed description: 
      Volatile anaesthetics increase neuromuscular block of neuromuscular blocking drugs. We tested
      the hypothesis, that sevoflurane would cause less vocal cord injuries than an intravenous
      anaesthesia with propofol. Sixty five patients were randomly assigned to the SEVO group
      (anaesthesia with sevoflurane) or TIVA group (anaesthesia with propofol). Vocal cord injuries
      were examined by stroboscopy before and 24 and 72 h after surgery; hoarseness was assessed up
      to 72 h.
    

Intervention name(s): Sevoflurane; propofol
Intervention type(s): Drug; Drug
Intervention description(s): Maintenance of anesthesia with sevoflurane 1.0 Vol%; Maintenance of anesthesia with propofol
Other intervention name(s): remifentanil; remifentanil
Intervention MeSH terms: Remifentanil; Propofol; Sevoflurane
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: hoarseness; sore throat; vocal cord injuries
Home Parenteral Nutrition for Malnourished Unresectable Stage IV Gastric Cancer
Condition: Metastatic Gastric Cancer
MeSH terms: Stomach Neoplasms
Study type: Interventional

Summary: 
      This survey is a single arm study to assess the effect of home parenteral nutrition on
      overall survival, cycles of salvage chemotherapy completed, side effects of salvage
      chemotherapy, quality of life, nutritional status, functional status, inflammatory status and
      complications of HPN in malnourished unresectable metastatic gastric cancer (mGC) patients in
      a single medical center. It is expected that about 20 subjects will be recruited during an
      estimated period of 48 months.
    

Detailed description: 
      Objectives:

        1. Primary Objective:

           The primary end points are overall survival and cycles of salvage chemotherapy completed
           of malnourished patients in unresectable mGCs

        2. Secondary Objectives:

      Side effects of salvage chemotherapy, quality of life, nutritional status, performance
      status, inflammatory status, safety and complications of HPN. The visit time schedules are at
      the time of enrollment before HPN is delivered, and at the beginning of every cycle of
      salvage chemotherapy

      Patient Selection and Enrollment:

      Twenty patients are planed to be enrolled

      Drop out The following reasons may consider to withdrawing a patient from the study

        1. Intolerance adverse events

        2. Patient will exceed defined safety cut-off values e.g. increase of a certain amount of a
           laboratory parameter.

        3. Violation of study protocol

        4. Withdraw of informed consent.

      Study duration and dates The study of this protocol is expected to be approximately 24
      months, with a subject recruitment period of 18 months (proposed to start in Sep 2014 and end
      in Sep 2018). The duration of the study or period of recruitment may vary.

      Treatment duration HPN is administered till resolution of malnutrition or till patient dies

      .
    

Intervention name(s): Oliclinomel N4 Per bag 1.5 L; Oxaliplatin; 5Fluorouracil; Leucovorin
Intervention type(s): Other; Drug; Drug; Drug
Intervention description(s): Home parenteral nutrition with 910 kcal/day , including 33 g amino acid/day, 120 g glucose/day, 30 g lipid/day and electrolyte, micro-element and vitamin according to the nutritional status of subjects and followed the standard procedure of the hospital (Oliclinomel N4 Per bag 1.5 L), was infused continuously daily in an infusion time ranged between 18-24 hours.
Other intervention name(s): Eloxatin; 5Fu; folinic acid
Intervention MeSH terms: Leucovorin; Fluorouracil; Oxaliplatin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: home parenteral nutrition
Safety And Efficacy Study Of Ziprasidone In Pediatric Psychotic Illness
Condition: Schizophrenia; Affective Disorders; Psychotic Disorder; Psychotic Mood Disorder
MeSH terms: Schizophrenia; Mental Disorders; Psychotic Disorders; Mood Disorders; Affective Disorders, Psychotic
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this research is to determine if Ziprasidone is safe and effective for use in
      children and adolescents with a psychotic illness, and to determine of Ziprasidone treatment
      leads to weight changes in children.
    

Detailed description: 
      Ziprasidone is a recently FDA approved antipsychotic, and it holds promise in the treatment
      of pediatric psychosis due to its low liability for weight gain and other side effects. This
      is important because early intervention in persons with a psychotic illness is important for
      their long-term treatment and outcome. Unfortunately, pediatric samples are often more
      sensitive to the side effects of psychotropic medications. Because psychotropic medications
      are often used by clinicians long before they are studied in pediatric populations, it is
      important to further study these agents.

      Twenty subjects with the diagnosis of a psychotic disorder, according to DSM-IV criteria,
      will be recruited for the study. If subjects have completed baseline evaluations, labs, EKG,
      and rating scales and are still eligible to participate, subjects will start on 20mg of
      Ziprasidone at night. The second week this will increase to 20 mg twice a day. At visits that
      occur at 2,4,6,and 8 weeks, the subject's dose of medication can be increased in 20mg per day
      increments. This allows for a maximum possible dose of 100mg. Dosage may be decreased at any
      time secondary to side effects.

      The potential benefits are that new information will be added to the field of pediatric
      psychiatry and the possibility that the medication may result in improved symptoms of
      psychosis. The potential benefits of this study outweigh the possible risks.
    

Intervention name(s): Ziprasidone
Intervention type(s): Drug
Intervention MeSH terms: Ziprasidone
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Schizophrenia; Pediatric psychotic disorders; Ziprasidone
Innovation-TiFP4-C101: A Study to Evaluate the Pharmacokinetics of TMC114 and TMC41629 After a Single Oral Dose of 2 Controlled-release Coformulations as Compared to an Immediate-release Coformulation of TMC114/TMC41629
Condition: HIV-I
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to compare the bioavailability (the degree to which a drug
      becomes available in the body after administration) of 3 different pharmaceutical
      preparations of a combination of two drugs, TMC114 and TMC41629. There will be 1 single oral
      intake (intake by mouth) of each of the 3 preparations. The study will also investigate the
      safety of use and the potential side effects of TMC114 and TMC41629, and determine the
      circulating levels of both compounds in your blood over time (pharmacokinetics), after a
      single intake.
    

Detailed description: 
      TMC41629 is a new investigational drug for the treatment of HIV. TMC114, is also known as
      Darunavir. In this randomized (study medication assigned by chance), open label trial
      (investigator and healthy volunteer know the name of the study medication), each healthy
      volunteer will receive a single dose of TMC114/TMC41629, in 3 subsequent sessions, Treatment
      A, Treatment B and Treatment C. Each capsule is equivalent to a dose of 200 mg of TMC114 and
      23.67 mg of TMC41629. Treatment A (immediate-release formulation) will serve as reference
      formulation. All medication intakes will be orally and in fasted conditions.The study
      duration is at least 19 days, excluding screening and follow-up visits with three single
      intakes with 72 hours follow-up per intake. Each volunteer will receive a single dose of each
      formulation. TMC114/TMC41629 is formulated as an oral immediate-release hard-gelatin capsule,
      as an oral gastro-resistant hard-gelatin capsule, enteric-coated and as an oral
      gastro-resistant hard-gelatin capsule, colon-targeted. Each capsule is equivalent to a dose
      of 200 mg of TMC114 and 23.67 mg of TMC41629.
    

Intervention name(s): TMC114; TMC41629
Intervention type(s): Drug
Intervention MeSH terms: Darunavir
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Innovation-TiFP4-C101; Innovation-C101; Innovation; TMC114/TMC41629; controlled-release coformulations; immediate-release coformulation; Pharmacokinetics