bioihbjkbjnl/mcl2 huggingface dataset:
Evaluation of Simplified Antiretroviral Treatment Strategies in HIV Infected Children Treated by Antiretroviral (ARV) Before One Year of Age
Condition: HIV Infections
MeSH terms: HIV Infections
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The MONOD trial aim to evaluate the implementation of early antiretroviral treatment
      strategies in HIV-infected infants and assess the feasibility and efficacy of simplifying the
      initial proposed regimen after a successful one year treatment. The initial treatment is
      AZT-3TC-LPV/r twice a day. After one year, the children will be randomized in one of the
      following : arm 1-reference AZT-3TC-LPV/r twice daily; arm 2-simplified ABC-3TC-EFV once
      daily.

      The perspective of this project is to identify antiretroviral strategies to improve treatment
      access and adherence for children in sub-saharian Africa.
    


Intervention name(s): AZT-3TC-LPV/r twice a day; ABC-3TC-EFV once a day
Intervention type(s): Drug; Drug
Intervention description(s): AZT sirup (10mg/ml): 4 mg/kg or 180 mg/m2 twice daily 3TC sirup (10mg/ml): 4 mg/kg twice daily LPV/r sirup (80/20 mg/ml): 12 mg/kg twice daily; ABC sirup (20mg/ml): 16 mg/kg once daily in the morning 3TC sirup (10mg/ml): 8 mg/kg once daily in the morning EFV sirup (30mg/ml): 25 mg/kg once daily in the morning before food intake
Intervention MeSH terms: Lamivudine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: HIV; Antiretroviral therapy; Infant; Sub Saharian Africa
Study to Evaluate the Efficacy and Safety of Armodafinil Treatment (150 mg/Day) as Adjunctive Therapy in Adults With Major Depression Associated With Bipolar I Disorder
Condition: Depression
MeSH terms: Depression; Depressive Disorder
Study type: Interventional
Phase: Phase 3

Summary: 
      The primary objective of the study is to determine whether armodafinil treatment, at a dosage
      of 150 mg/day, is more effective than placebo treatment as adjunctive therapy to mood
      stabilizers for treatment of adults with major depression associated with bipolar I disorder.
    


Intervention name(s): Armodafinil; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Armodafinil tablets, taken orally, once daily in the morning; Matching placebo tablets, taken orally, once daily in the morning
Other intervention name(s): Nuvigil; CEP-10953
Intervention MeSH terms: Modafinil
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Bipolar I Disorder
Improvement of the Accuracy of Spatial Representation of Invasive Exploratory Electrodes in Focal Epilepsy
Condition: Focal Epilepsy
MeSH terms: Epilepsy; Epilepsies, Partial
Study type: Observational

Summary: 
      Reconstruction software allows visualization of cortical structure in 3 dimensions, showing
      on a single picture the position of all the electrodes. The EEG signal of each recording plot
      of the electrode is analyzed and compared with the underlying brain structure reconstructed
      by the software. It is therefore possible to visualize 1) ictogenic and epileptogenic areas
      using neurophysiological stereoelectroencephalography (SEEG) data and 2) adjacent functional
      cortical areas with functional imaging and SEEG. Software makes it possible to determine the
      links between these areas. This study aims to show that using these software is an asset in
      surgical decision and in the choice of surgical strategy.

      Each patient has presurgical evaluation (usual care), including morphologic and (if
      necessary) functional MRI, EEG and SEEG. In this study, software will be used to analyze the
      processed data (FSL software, FMRIB laboratory, Oxford University and BrainVisa/Anatomist.
      The surgical decision will be taken according to the usual staff procedures, based on the
      usual examination results. After the decision making process, the staff will be asked to
      reconsider the surgical decision, according to the analysis provided by the software. The
      discrepancies between the decisions will be recorded.
    


Observational model: Other
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        patients with drug resistant focal epilepsy, potential candidates for surgery, scheduled
        for deep brain electrodes exploration.
A New Conception About Individualized Treatment Allocation for HCC
Condition: HCC; Transarterial Chemoembolization; Resection
Study type: Observational

Summary: 
      The current guidelines on hepatocellular carcinoma (HCC) aimed to build effective prognostic
      stratification strategies to guide therapeutic allocation; however, the current guidelines
      did not consider the simultaneous comparison of distinct therapies in similar populations.
      Here, the investigators aimed to develop and validate a new, integrated prognostic scheme for
      HCC patients using artificial intelligence (AI) to simulate the survival outcomes of patients
      allocated to different treatments.
    

Detailed description: 
      Given that liver resection (LR) and transarterial chemoembolization (TACE) are the mainstay
      curative and palliative therapies for HCC, respectively, patients who underwent LR or TACE
      were included in the study. Various prognostic AI algorithms were modeled using data from a
      large multi-institutional cohort, where LR and TACE were considered independent factors. The
      C-index, Brier score (BS), and area under the receiver operating characteristic curve (auROC)
      were calculated to estimate the AI models.
    

Intervention name(s): TACE
Intervention type(s): Procedure
Observational model: Other
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        Between January 2010 and October 2021, a total of 4991 consecutive HCC patients receiving
        LR or TACE from 15 Chinese tertiary hospitals were retrospectively screened. HCC was
        diagnosed based on either imaging or pathological results as previously described
Locally Delivered Atorvastatin & Rosuvastatin for Treatment of Furcation Defects in Chronic Periodontitis
Condition: Chronic Periodontitis
MeSH terms: Periodontitis; Chronic Periodontitis; Furcation Defects
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      Statins are one of the lipid lowering drugs that help in reducing cholesterol levels in the
      body by specifically inhibiting 3-hydroxy-3-methylglutaryl coenzyme A reductase; which is a
      rate limiting enzyme for cholesterol synthesis. Rosuvastatin (RSV) and atorvastatin (ATV)
      have shown to have bone stimulatory and anti-inflammatory effects.. The present study aims to
      explore the efficacy of 1.2% RSV and 1.2% ATV gel as a local drug delivery and redelivery
      system as an adjunct to scaling and root planing (SRP) for the treatment of degree II
      furcation defects.
    

Detailed description: 
      Statins are one of the lipid lowering drugs that help in reducing cholesterol levels in the
      body by specifically inhibiting 3-hydroxy-3-methylglutaryl coenzyme A reductase; which is a
      rate limiting enzyme for cholesterol synthesis. Rosuvastatin (RSV) and atorvastatin (ATV)
      have shown to have bone stimulatory and anti-inflammatory effects.. The present study aims to
      explore the efficacy of 1.2% RSV and 1.2% ATV gel as a local drug delivery and redelivery
      system as an adjunct to scaling and root planing (SRP) for the treatment of degree II
      furcation defects.

      Methods: Ninety patients with mandibular buccal class II furcation defects were randomly
      allocated into three treatment groups: SRP plus placebo gel (group 1), SRP plus 1.2% RSV gel
      (group 2) and 1.2% ATV gel (group3). Clinical and radiographic parameters were recorded at
      baseline then after 6 months. The gels were redelivered at the respective sites at this 6
      month appointment. Then again all clinical and radiographic parameters were recorded after 3
      months. (9 months from baseline)
    

Intervention name(s): placebo; Rosuvastatin; Atorvastatin
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Oral prophylaxis followed by placement of placebo gel; Oral prophylaxis followed by placement of rosuvastatin gel; Oral prophylaxis followed by placement of atorvastatin gel
Other intervention name(s): inactive drug; RSV; ATV
Intervention MeSH terms: Atorvastatin; Rosuvastatin Calcium
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Magnesium After Alcohol Withdrawal Treatment
Condition: Alcohol-Induced Disorders
MeSH terms: Alcohol-Induced Disorders
Study type: Interventional
Phase: Phase 4

Summary: 
      The primary purpose is to see if magnesium tablet supplementation will decrease elevated GGT
      enzyme activity in alcoholic patients immediately after they had been treated for alcohol
      withdrawal. The secondary aims are to find out whether supplementation decreases the activity
      of ASAT and ALAT enzymes, increases muscle strength, decreases blood pressure and decreases
      depressive symptoms among these patients.
    

Detailed description: 
      Magnesium (Mg) deficiency is common among alcoholics. Animal studies have shown that
      magnesium deficiency aggravates the hepatic damage caused by alcohol. One study on chronic
      alcoholics suggested that magnesium supplementation over six weeks decreases abnormally high
      activities of three enzymes related to liver function: serum gamma-glutamyltransferase (GGT),
      aspartate-aminotransferase (ASAT) and alanine-aminotransferase (ALAT), and increases muscle
      strength [4]. These results were, however, significant at the 5% level only when a 1-sided
      test was applied. It seems that magnesium supplementation may improve liver recovery after a
      drinking bout, but the evidence is not yet strong enough to warrant clear recommendations for
      clinical practice. Magnesium deficiency may also be one of the symptoms of depression and may
      aggravate hypertension. The primary purpose of the present randomized, parallel group, double
      blind trial is to see if oral magnesium supplementation will decrease elevated GGT enzyme
      activity in alcoholic patients immediately after they had been treated for alcohol
      withdrawal. The secondary aims are to find out whether supplementation decreases the activity
      of ASAT and ALAT enzymes, increases muscle strength, decreases blood pressure and decreases
      depressive symptoms among these patients.
    

Intervention name(s): Magnesium
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Hypnotic Intervention for Women With Chronic Pelvic Pain
Condition: Chronic Pain; Pelvic Pain; Psychological; Hypnosis, Animal
MeSH terms: Chronic Pain; Pelvic Pain
Study type: Interventional

Summary: 
      Objective: To establish whether the pilot online hypnosis design was well received by women
      with persistent pelvic pain and worthy of a full randomised control trial To establish
      whether hypnosis improves mental health outcomes, including anxiety, depression, life impact
      and catastrophizing, in women with chronic pelvic pain conditions.
    

Detailed description: 
      Design: Pilot Randomised Control Trial Methods: Twenty women with persistent pelvic pain
      completed assessment questionnaires and were recruited from a variety of social media sites
      related to persistent pelvic pain and randomly allocated to either control or hypnotic
      intervention groups. The intervention group completed a seven week online hypnotic
      intervention. The control group received no intervention. Both groups completed assessment
      and concluding questionnaires related to demographic information and the outcomes of
      interest. This included measures for anxiety, depression, pain, coping styles, pain related
      disability, pain catastrophizing and suggestibility. The results of the intervention and
      waitlist control groups were compared using linear mixed-effects modelling. Suggestibility
      was screened for at baseline using the Short Suggestibility Scale, and included in a
      secondary set of linear effects modelling.
    

Intervention name(s): Hypnotic intervention for persistent pelvic pain.; Control group persistent pelvic pain no intervention.
Intervention type(s): Other; Other
Intervention description(s): Education about persistent pelvic pain followed by 7 recordings of hypnosis intervention across 7 weeks accessed online through recordings.; Control group no hypnotic intervention. Waitlist control.
Intervention MeSH terms: Hypnotics and Sedatives
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Pilot randomised controlled trial with 2 parallel study arms.
Masking: None (Open Label)
Primary purpose: Treatment
Diaphragmatic Reinnervation of Tetraplegic Patients With Respiratory Insufficiency
Condition: Tetraplegia
MeSH terms: Quadriplegia
Study type: Interventional
Phase: Phase 4

Summary: 
      This study evaluates the diaphragmatic reinnervation by inferior laryngeal nerve in
      tetraplegic patients with ventilatory insufficiency.
    


Intervention name(s): reinnervation
Intervention type(s): Procedure
Intervention description(s): anastomosis between right inferior laryngeal nerve and right phrenic nerve
Other intervention name(s): laryngeal reinnervation
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: tetraplegia; reinnervation; phrenic nerve
Study To Assess Efficacy and Safety of Oglemilast in Patients With Chronic Obstructive Pulmonary Disease (COPD)
Condition: Pulmonary Disease, Chronic Obstructive
MeSH terms: Lung Diseases; Pulmonary Disease, Chronic Obstructive
Study type: Interventional
Phase: Phase 2

Summary: 
      This study will assess the safety and efficacy of a range of oglemilast doses. The study will
      be 14 weeks in duration. All patients meeting the eligibility criteria will be randomized to
      one of three doses of oglemilast or placebo.
    


Intervention name(s): Oglemilast; Placebo; Oglemilast; Oglemilast
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Oglemilast low dose, oral administration, once daily for 12 weeks; Placebo, oral administration, once daily for 12 weeks; Oglemilast middle dose, oral administration, once daily for 12 weeks; Oglemilast high dose, oral administration, once daily for 12 weeks
Other intervention name(s): GRC 3886; GRC 3886; GRC 3886
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Airflow Obstruction, Chronic; Chronic Airflow Obstruction; Chronic Obstructive Pulmonary Disease; Chronic Obstructive Airway Disease; Chronic Obstructive Lung Disease; COPD; COAD
A Single-Dose, Pharmacokinetic/Pharmacodynamic (PK/PD), & Safety Study of BIIB017 in Participants With Renal Impairment & Healthy Volunteers
Condition: Healthy; Renal Insufficiency
MeSH terms: Renal Insufficiency
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective of the study is to evaluate the pharmacokinetics (PK) of a single dose
      of PEGylated Interferon Beta-1a (BIIB017) administered subcutaneous in participants with
      renal impairment and in participants with normal renal function (healthy participants). A
      secondary objective of this study in this study population is to evaluate the safety and
      tolerability of a single dose of PEGylated Interferon Beta-1a administered subcutaneous.
    

Detailed description: 
      This study is an open-label, multicenter, non-randomized, serial-group study to estimate the
      effect of renal impairment on BIIB017 PK/PD. The study will be conducted at approximately 3
      sites in the US and will enroll approximately 35 participants: 6 healthy volunteers (normal
      renal function), 9 with mild renal impairment, 6 with moderate renal impairment, 8 with
      severe renal impairment, and 6 participants with end stage renal disease who require
      hemodialysis 2 to 3 times a week.
    

Intervention name(s): BIIB017(peginterferon beta-1a)
Intervention type(s): Drug
Intervention description(s): peginterferon beta-1a administered by a single subcutaneous (SC) injection using a pre-filled syringe on Day 1 at a dose of either 63 or 125 mcg depending on subpopulation assignment reflecting whether a healthy volunteer or level of renal impairment.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Septic Shock and Delirium Because of rSO2 Abnormalities in Intensive Care Unit Patients (The SAD BRAIN Study)
Condition: Septic Shock; Delirium; Renal Failure
MeSH terms: Shock, Septic; Delirium; Shock
Study type: Observational

Summary: 
      Delirium in the ICU is a prevalent problem occurring in up to 80% of ICU patients. A
      potential cause of delirium in ICU patients could be cerebral hypoxia. Septic shock is
      associated with high rates of delirium.

      The aim of this pilot study is two fold. First, to determine the feasibility and potential
      challenges of measuring cerebral oxygenation in ICU patients with severe sepsis and septic
      shock. And second, to see if the incidence and magnitude of cerebral desaturations correlated
      with ICU acquired delirium as measured by the Confusion Assessment Method (CAM) scores.
    


Intervention name(s): Observation
Intervention type(s): Other
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Adult patients admitted to the Intensive Care Unit with Septic Shock
First Time in Human (FTIH) Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of Single and Repeat Doses of GSK3439171A in Healthy Subjects and to Assess Food Effect
Condition: Muscular Dystrophies
MeSH terms: Muscular Dystrophies
Study type: Interventional
Phase: Phase 1

Summary: 
      The FTIH study with GSK3439171A will evaluate the safety of GSK3439171A in healthy subjects
      in order to avoid confounding factors due to the disease or concomitant drugs in patients.
      The study design is based on pre-clinical findings for GSK3439171A, contributing to the
      frequency, type and duration of safety assessment and monitoring during treatment periods in
      each cohort. The single dose assessments in Part A will be conducted to determine safety,
      tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of the study intervention in
      individuals before progressing to doses explored further in other parts of the study and will
      allow for any adjustments needed based on emerging safety, tolerability, and PK information.
      Part A will also serve to identify a dose for use in examining the effect of food on
      GSK3439171A exposure in Part C. In Part B, a single dose safety, tolerability and PK will be
      collected followed by progression of these subjects to the repeat dose portion of the study.
      The up to 14-day dosing was chosen as it is thought to provide sufficient safety and
      tolerability data to bridge to longer duration studies. The dosing period can be adjusted
      depending on PK and PD data collected in Part A of the study. Part B will involve more
      detailed PK/PD/metabolite assessments to better understand the impact of GSK3439171A on
      target engagement and metabolism in humans. Approximately 150 subjects will be screened to
      achieve 75 randomly assigned to study intervention. Duration for Part A, B and C will be
      approximately 10 weeks, 9 weeks and 8 weeks respectively.
    


Intervention name(s): GSK3439171A; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Oral solution with doses 0.5 mg up to 4.5 mg and capsule for doses 5 mg and upwards; Placebo oral solution to match with doses 0.5 mg up to 4.5 mg and capsule for doses 5 mg and upwards
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Part A is a Crossover group single ascending dose study with 2 arms per cohort that is subject and investigator blinded. Part B is a Parallel group repeat dose study with 2 arms per cohort that is subject and investigator blinded. Part C is a Crossover group food effect study with 2 arms per cohort that is not-masked."
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Dose proportionality; Food effect; Pharmacokinetics; FTIH; Pharmacodynamics; Dose Escalation
Evaluation of the Potential Effects of SSR149415 on the Hypothalamic-pituitary-adrenal Axis in Outpatients With Major Depressive Disorder
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Study type: Interventional
Phase: Phase 2

Summary: 
      Primary Objective:

      - To evaluate the effects of two fixed doses of SSR149415 (250 mg bid and 100 mg bid) on
      hypothalamic-pituitary-adrenal axis function in patients with major depressive disorder.

      Secondary Objectives:

        -  To evaluate the tolerability and safety of SSR149415 in patients with major depressive
           disorder.

        -  To evaluate the efficacy of two fixed doses of SSR149415 compared to placebo in patients
           with major depressive disorder.

        -  To evaluate plasma concentrations of SSR149415.
    

Detailed description: 
      The study consisted of three segments (A, B and C). Segment A was a 1 to 4-week, drug-free,
      screening and baseline period. Segment B was a 4-week, double-blind period. After the last
      dose of double-blind study medication in Segment B, all patients had to enter Segment C, a
      1-week drug-free, follow-up period.

      The total study duration for one patient participating in all segments of the study was 6
      weeks.
    

Intervention name(s): VASOPRESSIN V1B RECEPTOR ANTAGONIST (SSR149415); Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Pharmaceutical form: Capsule Route of administration: oral; Pharmaceutical form: Capsule Route of administration: Oral
Intervention MeSH terms: Vasopressins; Arginine Vasopressin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment