bioihbjkbjnl/mcl2 huggingface dataset:
Artemether-Lumefantrine (AL) Unit Dose Pre-packs Versus Blister Packs
Condition: Malaria
MeSH terms: Malaria; Blister
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to determine if adherence and effectiveness of AL in the
      treatment of uncomplicated malaria in children aged under five years using blister packs with
      pictorial leaflets can be at levels comparable to those with unit dosed age specific
      pre-packs.
    

Detailed description: 
      Prompt and adequate treatment of clinical malaria episodes remains one of the key elements of
      malaria control and this partly depends on patients' compliance to treatment. Uganda adopted
      Artemether-Lumefantrine (AL) as first line treatment for uncomplicated malaria. This is
      available at the health facilities in form of 6 dose pre-packs with different doze strengths
      in different packages. However, concerns about the costs and stock-outs of these packages
      have been raised and alternative equally efficacious alternatives need to be determined in
      order to reduce these problems. This study will assess if AL blister-packs can act as
      alternatives to the unit dose age specific pre-packs in the public sector
    

Intervention name(s): AL Blister-packs with Instruction leaflets; AL unit dose age specific pre-packs
Intervention type(s): Drug; Drug
Intervention description(s): AL Blister packs with instruction leaflets will be dispensed; Age specific colour coded Unit dose pre-packs will be used
Other intervention name(s): Coartem Blister packs; Coartem pre-packs
Intervention MeSH terms: Artemether, Lumefantrine Drug Combination
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Malaria
Evaluation of Reactogenicity and Safety of GSK Biologicals' Rotarix™ (Human Rotavirus Vaccine) in Infants
Condition: Infections, Rotavirus
MeSH terms: Rotavirus Infections
Study type: Observational

Summary: 
      This Post Marketing Surveillance (PMS) will collect reactogenicity and safety data on the use
      of human rotavirus vaccine in healthy infants aged from 6 weeks (first dose) to not more than
      24 weeks (second dose).
    


Intervention name(s): Rotarix™
Intervention type(s): Biological
Intervention description(s): Two oral doses, with at least 4 weeks interval in-between
Keywords: Gastroenteritis
Comparative Study of NXL103 Versus Linezolid in Adults With Acute Bacterial Skin and Skin Structure Infections (ABSSSI)
Condition: Acute Bacterial Skin and Skin Structure Infections
MeSH terms: Infections; Communicable Diseases; Skin Diseases, Bacterial
Study type: Interventional
Phase: Phase 2

Summary: 
      The objective of this study is to evaluate the efficacy and safety of oral NXL103 vs.
      established treatment of acute bacterial infection in adults.
    


Intervention name(s): NXL103; Linezolid
Intervention type(s): Drug; Drug
Intervention description(s): BID for 7-14 days; BID for 7-14 days
Intervention MeSH terms: Linezolid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Study of Indomethacin Capsules to Treat Pain Following Bunionectomy
Condition: Other Acute Postoperative Pain
MeSH terms: Pain, Postoperative
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to determine whether Indomethacin [Test] Capsules are safe and
      effective for the treatment of postoperative bunionectomy pain.
    


Intervention name(s): Indomethacin; Indomethacin; Indomethacin; Placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): capsules, 40 mg, TID; capsules, 40 mg, BID; capsules, 20 mg, TID; capsules
Intervention MeSH terms: Indomethacin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Neuroimaging of Anesthetic Modulation of Human Consciousness
Condition: Healthy
Study type: Interventional
Phase: Phase 4

Summary: 
      This study's purpose is to see if mental functions take place during different levels of
      anesthesia, using a commonly used drug (Propofol). fMRI (functional Magnetic Resonance
      Imaging, or "brain imaging") shows areas in the brain involved in thinking at different
      depths of anesthesia.
    

Detailed description: 
      Administering anesthetic drugs to suppress consciousness is an imperatively important step in
      major surgical operations. Yet the neurobiological mechanisms that underlie loss of
      consciousness under general anesthesia remain elusive. Despite advancements in understanding
      the molecular, synaptic, and cellular effects of anesthetics, the large-scale, systems-level
      modulation of neuronal processes that support conscious cognitive functions is incompletely
      understood. While profound decreases in global and regional brain metabolism, blood flow, and
      functional connectivity have been reported, these changes often fail to correlate with the
      loss and return of consciousness. To date, there is no "consciousness meter" or "gold
      standard" to objectively assess and monitor the level of consciousness under general
      anesthesia. Several studies suggest that residual cognitive functions may not completely
      vanish under general anesthesia; however, the level and complexity of residual information
      processing in the anesthetized brain remains unknown. Finally, the neurobiological mechanisms
      that govern anesthesia induction and emergence appear to be partially different, but the
      relevance of these differences to the modulation of the state of consciousness is unclear.
    

Intervention name(s): Propofol
Intervention type(s): Drug
Intervention description(s): Propofol administration
Intervention MeSH terms: Propofol
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Circulating Tumor DNA (ctDNA)-Guided Late-Line Treatment in Patients With Late-Stage Breast Cancer
Condition: Metastatic Breast Cancer; Circulating Tumor DNA; Gene Abnormality
MeSH terms: Breast Neoplasms
Study type: Observational

Summary: 
      This is a retrospective, observational, multi-center clinical study of circulating tumor DNA
      (ctDNA) to guide late-line therapy in late-stage metastatic breast cancer patients.
    

Detailed description: 
      This study aims to evaluate the feasibility of plasma ctDNA mutation in guiding late-line
      treatment for late-stage metastatic breast cancer patients. Meanwhile, this study tries to
      evaluate the curative effect of ctDNA subtype-guided late-line therapy.
    

Intervention name(s): Control group; Case group
Intervention type(s): Drug; Drug
Intervention description(s): Physician chosen treatment; Druggable ctDNA alterations-guided therapy
Other intervention name(s): PARP inhibtior; EGFR inhibitor; CDK4/6 inhibitor; AR antagonists; anti-VEGFR; anti-FGFR; Fulvestrant; ADC drugs; PI3K inhibitor; anti-HER2 treatment; HDAC inhibitor
Intervention MeSH terms: Fulvestrant; Histone Deacetylase Inhibitors
Observational model: Case-Control
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        This cohort study recruited consecutive patients with recent progression of metastatic TNBC
        after multiple lines of chemotherapy or of HR+ or HER2+ metastatic breast cancer after
        multiple lines of endocrine or targeted therapy.
      
Biospecimen description: 
      Peripheral blood lymphocytes (PBL) and plasma
Adaptive Recalibration of Prosthetic Leg Neural Control System
Condition: Amputation
Study type: Interventional

Summary: 
      The purpose of this study is for transfemoral amputees to walk with an experimental robotic
      prosthesis. Electric signals will be measured from their muscles and used to help control an
      artificial leg. The investigators will record from sensors placed on a prosthesis and
      electric signals measured from muscles in the participants leg to see if the investigators
      can develop better computer programs to help predict subject actions and prostheses function.
    

Detailed description: 
      The investigators propose to use a powered knee-ankle prosthesis that is not yet commercially
      available. The hierarchical control framework the investigators are developing will be
      equally applicable to any prosthetic leg that needs to be transitioned between ambulation
      modes, including microprocessor-controlled passive devices.

      The overall objective is to develop and evaluate an adaptive framework for controlling lower
      limb prostheses that compensates for changes in EMG signals. When a participant walks on a
      lower limb prosthesis, the output of the high-level controller (or ambulation mode predictor)
      directly influences patterns generated by the participant. After the participant has
      completed the subsequent stride, a gait pattern estimator (GPE), will provide a label of what
      the participant actually did. This may differ from the ambulation mode predictor output if
      there was a misclassification. The label will then be used to update the ambulation mode
      predictor algorithm such that future steps are predicted with higher accuracies. Finally, the
      resulting system will be transferred to an embedded system and tested in real-time with
      transfemoral amputees and compared to a non-adaptive system.
    

Intervention name(s): Powered knee and ankle prosthesis
Intervention type(s): Device
Intervention description(s): A powered knee and ankle prosthesis developed by Vanderbilt University.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Transfemoral
Impact of New Biomarkers on Maintenance of Sinus Rhythm After Cardioversion or Ablation of Atrial Fibrillation
Condition: Atrial Fibrillation
MeSH terms: Atrial Fibrillation
Study type: Interventional

Summary: 
      The Biorhythm study aims to investigate the utility of new biomarkers (e.g. MR proANP, ST2)
      measured pre-procedure for the prediction of procedural success in patients with atrial
      fibrillation undergoing cardioversion or ablation.
    

Detailed description: 
      This is a prospective, observational, multicentre study of patients with paroxystic or
      persistent atrial fibrillation scheduled to undergo cardioversion or ablation of AF in
      routine practice. Serum levels of MR proANP and ST2 pre-procedure will be measured to attempt
      to identify a threshold that carries prognostic value for procedural success (maintenance of
      sinus rhythm at one year).
    

Intervention name(s): Ablation of atrial fibrillation; Cardioversion
Intervention type(s): Procedure; Procedure
Intervention description(s): Pulmonary vein isolation by radiofrequency or cryoablation.; External electric shock delivery under general anesthesia.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Effect of Inspiratory Muscle Training on Exercise Performance and Quality of Life in Patients With Chronic Obstructive Pulmonary Disease
Condition: Chronic Obstructive Pulmonary Disease
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Respiratory Aspiration
Study type: Interventional

Summary: 
      The aim is to study effectiveness of inspiratory muscle training as a part of exercise
      training in patients with Chronic Obstructive Pulmonary Disease (COPD) and if it adds to
      general exercise training program in regard to respiratory muscle strength, dyspnea, exercise
      performance and quality of life.
    


Intervention name(s): theophylline, long acting bronchodilators (LABD) or combined LABD and inhaled steroids according to GOLD recommendations; peripheral muscles exercise training; inspiratory muscle training
Intervention type(s): Drug; Other; Device
Intervention description(s): Patients started breathing at a resistance that required generation of 30% of their PImax for one week. The load was then increased incrementally, 5-10%, to reach generation of 60% of their PImax at the end of the first month. Specific IMT was then continued at 60% of their PImax adjusted weekly to the new PImax achieved.
Other intervention name(s): uniphyllin, foradil, spiriva, miflonide; Threshold® Inspiratory Muscle Trainer, Healthscan, New Jersey, NJ, USA
Intervention MeSH terms: Theophylline; Bronchodilator Agents
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: COPD; inspiratory muscle training; dyspnea; Quality of Life
Clinical Trial to Evaluate the Safety and Analgesic Efficacy of VVZ-149 in Lumbar Radiculopathy (Sciatica)
Condition: Radiculopathy; Sciatica
MeSH terms: Radiculopathy; Sciatica
Study type: Interventional
Phase: Phase 1

Summary: 
      Double-blind, crossover, randomized, 3x3 Latin square, placebo-controlled study of single
      intravenous dose administration of VVZ-149. To demonstrate assay sensitivity, lidocaine will
      be administered as a positive control. The study will take place during a single inpatient
      visit involving three separate treatment periods, each with a washout of (>16-hours. Study
      drugs (VVZ-149 vs. lidocaine vs. normal saline, NS) will be administered intravenously.
    


Intervention name(s): VVZ-149; Lidocaine; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention MeSH terms: Lidocaine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Neuropathic Pain; Sciatica
A Multinational, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Investigate the Efficacy, Safety and Duration of Effect of a Single Administration of Various Doses of Cetrorelix SR in Subjects With Histologically Confirmed Endometriosis
Condition: Endometriosis
MeSH terms: Endometriosis
Study type: Interventional
Phase: Phase 2

Summary: 
      Identify effective doses of cetrorelix SR in the treatment of symptoms of endometriosis,
      describe dose effect relationship and duration of symptom relief
    


Intervention name(s): Cetrorelix
Intervention type(s): Drug
Intervention MeSH terms: Cetrorelix
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Endometriosis; Cetrorelix; Hormone; Symptoms relief; Safety; Tolerability; Pharmacodynamic; Pharmacokinetic
An Extension Study of Linifanib (ABT-869) in Subjects With Advanced or Metastatic Solid Tumors
Condition: Advanced Solid Tumors
MeSH terms: Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      An extension study of linifanib in subjects with advanced or metastatic solid tumors.
    

Detailed description: 
      This study is designed to evaluate the safety of linifanib in subjects with advanced or
      metastatic solid tumors.
    

Intervention name(s): linifanib
Intervention type(s): Drug
Intervention description(s): QD daily
Other intervention name(s): ABT-869
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Safety, Tolerability and Prophylactic Antiviral Activity of Neumifil Against Influenza Via a Human Viral Challenge Model
Condition: Influenza Viral Infections
MeSH terms: Influenza, Human; Virus Diseases
Study type: Interventional
Phase: Phase 2

Summary: 
      Study to assess the efficacy and safety of a multiple dose regimen and a single dose regimen
      of intranasal Neumifil, administered prior to challenge with Influenza virus in healthy adult
      participants
    

Detailed description: 
      This is a single-centre, randomized, double-blind, placebo-controlled study in healthy adult
      participants to assess the pre-exposure prophylactic antiviral activity of Neumifil via a
      human viral challenge model.

      Participants will enter the quarantine unit on Day -4.

      Participants will be randomized to receive either active (single dose), active (multiple
      dose) or placebo in a 3:3:4 ratio followed by influenza viral challenge on Day 0.

      Participants will leave the unit on Day 8, provided that no virus is detected by a
      qualitative virus antigen test and the participant has no clinically significant symptoms. A
      final follow-up will be performed on Day 28.
    

Intervention name(s): Neumifil; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Liquid for intranasal spray administration; Liquid for intranasal spray administration
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized, Double-blind, Placebo-controlled study
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: Influenza; Human Challenge; Prophylaxis
A Study of WX390 in Patients With Advanced Solid Tumors With PIK3CA Mutations
Condition: PIK3CA Mutation-Related Tumors
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The goal of this clinical trial is to evaluate the safety and preliminary efficacy of WX390
      in patients with advanced solid tumors. The main question it aims to answer is:

      • safety and preliminary efficacy in WX390 therapy. Participants will be treated with WX390
      orally and follow the efficacy and safety evaluation according to the protocol.
    

Detailed description: 
      This study is a multicenter, open-label phase Ib/IIa clinical trial for patients with
      advanced solid tumors who have failed standard treatment. The study adopts a basket design,
      divided into 6 cohorts, with a total of 70-80 advanced solid tumor patients with PIK3CA
      mutations enrolled. Participants will receive WX390 treatment administered continuously
      daily, with each cycle lasting 28 days, until disease progression or intolerable toxicity
      occurs. During the study, safety and efficacy will be evaluated, with efficacy assessment
      based on RECIST 1.1. In addition, the study will collect tumor tissue or blood samples from
      the participants to explore the relationship between other biomarkers and treatment efficacy,
      as well as the impact of changes in PIK3CA mutation status before and after treatment on
      efficacy.
    

Intervention name(s): WX390
Intervention type(s): Drug
Intervention description(s): Participants will receive WX390 1.1 mg tablet orally once a day for a continuous 28-day cycle.
Other intervention name(s): WXFL10030390
Intervention model: Single Group Assignment
Intervention model description: WX390 continuous oral dosing (1.1 mg once a day).
Masking: None (Open Label)
Primary purpose: Treatment
Culture-sensitive Emotion Regulation Group Therapy for Traumatized Refugees
Condition: Trauma
MeSH terms: Hypersensitivity
Study type: Interventional

Summary: 
      There is a lack of studies on treatment effect in traumatised refugees. Recent findings
      indicate that emotion regulation deficits play a key role in PTSD also among traumatized
      refugees and highlight the importance and potential directions for the development of an
      emotion regulation training for refugees. In this study, the investigators therefore want to
      examine the effectiveness of a new, transdiagnostic, cultural-sensitive group therapy, which
      systematically teaches specific emotion regulation strategies. Participants will be randomly
      assigned to either the emotion regulation training, delivered in group format or a wait list
      control condition. The study takes place in cooperation with REFUGIO Munich, which is a
      treatment centre specialised in the treatment of traumatised refugees. Clinicians will
      deliver the treatment to traumatized asylum seekers and refugees that report difficulties in
      emotion regulation. The investigators will examine if refugees and asylum seekers in the
      intervention group will show improvements in psychological symptoms, social functioning as
      well as in emotion regulation in comparison to a wait list control group which will receive
      the treatment after the intervention group has completed. The group therapy covers 14
      sessions and has a cognitive-behavioural background. It focuses on conveying strategies to
      cope with intense feelings and the patients should gain a sense of self-efficacy and control
      over their trauma-relevant feelings and symptoms. Qualified interpreters will be used in the
      assessments as well as group therapies.
    


Intervention name(s): Skills training of Affect-Regulation - A culture-sensitive approach: STARK
Intervention type(s): Behavioral
Intervention description(s): Emotion Regulation Group Therapy, 14 sessions, 1.5 hour sessions, group therapy, meeting weekly.
Other intervention name(s): German title: Skills-Training der Affektregulation: Ein kultursensibler Ansatz: STARK
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: trauma treatment; Refugees; Emotion regulation; Group therapy; randomized controlled; PTSD
the Effect of Different Drugs and Infusion Ways on Degree of Postoperative Comfort
Condition: Analgesia, Patient-Controlled
Study type: Interventional
Phase: Phase 4

Summary: 
      To explore the effect of different drugs and infusion ways on degree of postoperative
      comfort.Patients undergoing spinal neoplasm surgery receive different patient controlled
      analgesia(PCA) drugs postoperatively,one group is sufentanil,the other is hydromorphone. Then
      each drug group will be divided into two subgroups according to the infusion
      way,intravenously,subcutaneously. During the patient controlled analgesia period, patients'
      degree of comfort,pain score,sleep quality, the degree of side reaction will be recorded.
    


Intervention name(s): intravenous sufentanil; subcutaneous sufentanil; intravenous hydromorphone; subcutaneous hydromorphone; intravenous sufentanil and dexmedetomidine; subcutaneous sufentanil and dexmedetomidine; intravenous hydromorphone and dexmedetomidine; subcutaneous hydromorphone and dexmedetomidine
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): The PCA pumps contain sufentanil . And the pump is connected to participants intravenously .; The PCA pumps contain sufentanil. And the pump is connected to participants subcutaneously.; The PCA pumps contain hydromorphone. And the pump is connected to participants intravenously .; The PCA pumps contain hydromorphone. And the pump is connected to participants subcutaneously.; The PCA pumps contain sufentanil and dexmedetomidine. And the pump is connected to participants intravenously .; The PCA pumps contain sufentanil and dexmedetomidine. And the pump is connected to participants subcutaneously.; The PCA pumps contain hydromorphone and dexmedetomidine. And the pump is connected to participants intravenously.; The PCA pumps contain hydromorphone and dexmedetomidine. And the pump is connected to participants subcutaneously
Other intervention name(s): SI; SS; HI; HS; SDI; SDS; HDI; HDS
Intervention MeSH terms: Sufentanil; Dexmedetomidine; Dsuvia; Hydromorphone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Supportive Care