bioihbjkbjnl/mcl2 huggingface dataset:
Effects of Home-based Inspiratory Muscle Training in Patients With IPF
Condition: Idiopathic Pulmonary Fibrosis; IPF
MeSH terms: Pulmonary Fibrosis; Idiopathic Pulmonary Fibrosis; Respiratory Aspiration; Fibrosis
Study type: Interventional

Summary: 
      The aim of this study is to investigate the effects of the home-based inspiratory muscle
      training program on lung functions, dyspnea, inspiratory muscle strength, functional capacity
      and quality of life in patients with idiopathic pulmonary fibrosis. Patients are evaluated
      before the inspiratory muscle training and after 8 weeks of training.
    

Detailed description: 
      The IMT protocol consisted of home-based high-intensity daily training - two cycles of 30
      breaths with a 1-min rest between sets, twice a day for 8 weeks using an IMT Threshold device
      (Threshold IMT Philips® Respironics, Inc). The intensity of the training was set to 50% of
      each patient's maximal inspiratory pressure measured every week and was adjusted weekly based
      on the modified Borg scale from 4 to 6 regarding respiratory effort performed during the
      session. Patients are evaluated before the inspiratory muscle training and after 8 weeks of
      training.
    

Intervention name(s): Inspiratory Muscle Training (IMT); Sham IMT
Intervention type(s): Device; Device
Intervention description(s): The IMT protocol will consist of home-based high-intensity daily training - two cycles of 30 breaths with a 1-min rest between sets, twice a day for 8 weeks using an IMT Threshold device (Threshold IMT Philips® Respironics, Inc). The intensity of the training will be set to 50% of each patient's maximal inspiratory pressure measured every week and was adjusted weekly based on the modified Borg scale from 4 to 6 regarding respiratory effort performed during the session.; The IMT protocol will consist of home-based daily training - two cycles of 30 breaths with a 1-min rest between sets, twice a day for 8 weeks using an IMT Threshold device (Threshold IMT Philips® Respironics, Inc). The intensity of the training will be set to the lowest intensity of the IMT Threshold device.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: This study was designed as a prospective and experimental study. Participants were randomly divided into two groups; a study group and a control group. The study group will perform inspiratory muscle training at 50% of maximal inspiratory pressure (MIP), and the control group received sham training for 8 weeks.
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: idiopathic pulmonary fibrosis; inspiratory muscle training; home-based; rehabilitation
Interactive Exoskeleton Robot for Walking - Ankle Joint
Condition: Stroke
Study type: Interventional

Summary: 
      A novel interactive exoskeleton robotic system with embedded force and motion sensors will be
      developed to facilitate walking of stroke patients with hemiparesis. The robot will
      synchronise with the gait pattern of the stroke patient to provide assistance in ankle
      dorsiflexion during swing phase. It is hypothesised that the robot can facilitate stable and
      longer walking distance for stroke patients with drop foot problem. It can be applied on
      unilateral side, which is suitable for stroke patients with hemiparesis. The whole system
      design is lightweight, compact, comfortable, and user-friendly in hospital or at home
      settings.
    

Detailed description: 
      In this clinical trial, participated stroke patients will be divided into two groups: Robotic
      group and Sham group. Stroke patients in both groups will participate in a 20-session gait
      training program, which includes overground walking and stair climbing exercises. Robotic
      group will walk with the powered Ankle Robot, which provide ankle dorsiflexion support during
      swing phase of walking; Sham group will walk with the Ankle Robot with very low assistance
      level, which provide only tactile feedback but no ankle support in order to evaluate the
      placebo effect. A series of clinical assessments will be carried out to assess the functional
      recovery in stroke patients before and after the gait training program.
    

Intervention name(s): Ankle Robot with Power Assistance; Sham
Intervention type(s): Device; Device
Intervention description(s): Stroke patients will enrol in a 20-session gait training program for at least two sessions per week. In each session, the stroke patient will walk overground continuously for 2 * 10 minutes and walk up/down a staircase (about 10 steps per flight) for 10 minutes, rest will be provided in between each round of walking or stair climbing. This training can promote gait recovery and physical fitness.
They will wear the Ankle Robot during the gait training. The motor will synchronise with the paretic-side gait pattern to provide dorsiflexion moment during swing phase, and free the ankle joint when the sole is loaded.; Stroke patients will enrol in a 20-session gait training program for at least two sessions per week. In each session, the stroke patient will walk overground continuously for 2 * 10 minutes and walk up/down a staircase (about 10 steps per flight) for 10 minutes, rest will be provided in between each round of walking or stair climbing. This training can promote physical fitness.
They will wear the Ankle Robot during the gait training. The robot will synchronise with the paretic-side gait pattern to the Ankle Robot provides very low assistance which can be barely perceived by the stroke patient but does not suffice to support the ankle dorsiflexion.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Treatment
A Phase 1 Study of an Investigational Drug, ALN-AT3SC, in Healthy Volunteers and Hemophilia A or B Patients
Condition: Hemophilia A; Hemophilia B
MeSH terms: Hemophilia A; Hemophilia B
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine the safety, tolerability, and pharmacokinetics of
      ALN-AT3SC in healthy volunteers and Hemophilia A or B patients.
    


Intervention name(s): ALN-AT3SC; Sterile Normal Saline (0.9% NaCl)
Intervention type(s): Drug; Drug
Intervention description(s): Ascending doses of ALN-AT3SC by subcutaneous (sc) injection; Calculated volume to match active comparator
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
H5-VLP + GLA-AF Vaccine Trial in Healthy Adult Volunteers
Condition: Influenza A Subtype H5N1 Infection
MeSH terms: Influenza, Human; Influenza in Birds
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine the safety, tolerability, and immunogenicity in
      healthy adult subjects of an investigational vaccine being developed for the prevention of
      pandemic influenza. The vaccine, identified as H5-VLP + GLA-AF, consists of a recombinant
      influenza virus H5 protein (hemagglutinin from A/Indonesia/5/2005) produced in a plant-based
      expression system assembling into virus-like particles together with the adjuvant GLA-AF.
    


Intervention name(s): H5-VLP + GLA-AF; H5-VLP alone; H5-VLP + Alhydrogel(R); Licensed H5N1 vaccine
Intervention type(s): Biological; Biological; Biological; Biological
Intervention description(s): H5-VLP antigen and GLA-AF adjuvant. 2 injections at Days 0, and 21.; H5-VLP antigen alone. 2 injections at Days 0, and 21.; H5-VLP antigen and Alhydrogel(R) adjuvant. 2 injections at Days 0, and 21.; Licensed H5N1 vaccine. 2 injections given on Days 0 and 21.
Intervention MeSH terms: Aluminum Hydroxide
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: Influenza; Avian; H5N1; H5-VLP; GLA; GLA-AF
Study of Pegylated Human Recombinant Arginase for Liver Cancer
Condition: Neoplasm; Hepatocellular Carcinoma
MeSH terms: Carcinoma; Carcinoma, Hepatocellular
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine whether recombinant human arginase (PEG-BCT-100) is
      safe and effective in the treatment of advanced hepatocellular carcinoma (HCC).
    

Detailed description: 
      The primary objectives of this study are:

        -  To establish a safe dose level for weekly intravenous administration of PEG- BCT-100
           (rhArgIpeg5000) based on clinical and laboratory safety assessments following a range of
           doses (from 500 to >5000 U/kg).

        -  To define the optimal biological dose (OBD) of PEG-BCT-100 based on the pharmacodynamics
           (PD) of arginine depletion (ADD) relative to plasma PK of PEG- BCT-100.

        -  To evaluate any objective tumor responses to PEG-BCT-100 in HCC patients receiving
           weekly doses of PEG-BCT-100 alone and in combination with standard doses of doxorubicin

      Secondary objectives of this study are:

        -  To define any toxicities associated with the metabolic and cellular alterations of ADD
           relative to dose and PK of PEG-BCT-100 (rhArgIpeg5000).

        -  To develop a safe and biologically active dose and schedule for PEG-BCT-100 treatment in
           phase 2 trials, either as monotherapy or in combination with best standard of care
           chemotherapy.

        -  To confirm the safety and initial anti-tumor activity of the preferred dose and regimen
           of PEG-BCT-100 in 18 additional patients with advanced HCC
    

Intervention name(s): Pegylated Recombinant Human Arginase I; Doxorubicin
Intervention type(s): Biological; Drug
Intervention description(s): Week 1 (Single Dose); Weeks 3 - 11 (Weekly Dose x 8 weeks)in 8 escalation doses; Weeks 13-24 (once every 3 weeks)
Other intervention name(s): PEG-BCT-100; Adriamycin
Intervention MeSH terms: Doxorubicin; BCT-100
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Neoplasm; Hepatocellular Carcinoma
Clinical Assessment of Safety and Tolerability of the New Monoclonal Humanized Antibody CaCP29
Condition: Drug Safety
Study type: Interventional
Phase: Phase 1

Summary: 
      The novel humanized monoclonal antibody CaCP29 was developed to control the inflammatory
      response to various stimuli in humans and espacially during sepsis. Purpose of this phase I
      clinical trial in healthy human males is to investigate various parameters concerning safety
      and tolerability of CaCP29 and assess pharmacokinetic and pharmacodynamic parameters.
    

Detailed description: 
      The acute inflammatory innate host response, as being present during the development of
      sepsis and various other acute inflammatory diseases, represents a powerful mechanisms which
      can lead to destruction of host tissue and severe organ dysfunction. CaCP29 was developed to
      lower the complement mediated acute inflammatory response and thereby control the extend of a
      strongly activated often times self-destructive inflammatory response by controlling
      activation of a key inflammatory mechanism.
    

Intervention name(s): CaCP29, a humanized monoclonal antibody
Intervention type(s): Biological
Intervention description(s): CaCP29 or placebo single i.v. infusion in ascending doses in healthy human males
Intervention MeSH terms: Antibodies; Antibodies, Monoclonal
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: sepsis; inflammation; complement; immune system
Whole Milk Versus Whey Protein Supplement and Resistance Exercise
Condition: Muscle Development
Study type: Interventional

Summary: 
      The purpose of the study is to examine the effects of consuming protein supplement (whey)
      compared to whole milk immediately after bouts of resistance training on muscular strength
      and body composition.
    


Intervention name(s): Whey protein; Chocolate milk; Sugar
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): 18g protein, immediately after training, 9 weeks; 500ml chocolate milk, immediately after training, 9 weeks; 55-65g maltodextrin solution, immediately after training, 9 weeks
Other intervention name(s): protein supplement; Milk; Maltodextrin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Keywords: Lean tissue; Strength condition; Protein; Amino Acid
Effects of Food on the Pharmacokinetics of Tesetaxel 10 mg Capsules
Condition: Solid Tumors
Study type: Interventional
Phase: Phase 1

Summary: 
      This study explores the effects of food (a high-fat meal) on the pharmacokinetics of
      tesetaxel.
    

Detailed description: 
      This study is being conducted to determine whether the pharmacokinetics of a single dose of
      tesetaxel administered as a capsule is affected by co-administration with food (a high-fat
      meal).
    

Intervention name(s): Tesetaxel 10 mg with and then without food; Tesetaxel 10 mg without and then with food
Intervention type(s): Drug; Drug
Intervention description(s): Treatment Period 1: Tesetaxel 10 mg in the fed state; Treatment Period 2: Tesetaxel 10 mg in the fasted state; Treatment Period 1: Tesetaxel 10 mg in the fasted state; Treatment Period 2: Tesetaxel 10 mg in the fed state
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Keywords: Advanced solid tumors
The Use of Acupuncture for the Treatment of Vulvar Vestibulitis
Condition: Vestibulodynia
MeSH terms: Vulvodynia; Vulvar Vestibulitis
Study type: Interventional

Summary: 
      Randomized controlled trial designed to determine whether acupuncture is an effective
      treatment for vestibulitis.
    

Detailed description: 
      Patients were randomized to five acupuncture sessions designed to treat pain in the vulvar
      area (study group), or five acupuncture sessions designed for tranquility (controls).
      Participants and evaluating gynecologists were blinded to randomization. Participants were
      examined clinically before treatment and one month after completion of assigned treatment; at
      both visits they completed the Female Sexual Function Index (FSFI) questionnaire.

      FSFI scores for pain during intercourse and total score were used to evaluate change. The
      examining gynecologist evaluated the degree of sensitivity to touch and the degree of local
      erythema. Response to treatment was evaluated for each group before and after treatment, and
      for study group compared to the control group.
    

Intervention name(s): Acupuncture
Intervention type(s): Procedure
Intervention description(s): Patients randomized to the study group received five sessions of acupuncture in a series of points in the lower abdomen, lower back, hands, and feet. This combination of acupoints is believed to impact on the genital area, raise the pain threshold, and counteract inflammation. Control group patients received five sessions of acupuncture at acupoints that are believed to have no influence on the genital area, but are believed to have a general sedative effect.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Effects of Anesthetic Techniques on Renal Function
Condition: Congenital Heart Disease; Acute Kidney Injury
MeSH terms: Acute Kidney Injury; Heart Diseases; Heart Defects, Congenital
Study type: Observational

Summary: 
      This study evaluates Different effects of two anesthetic techniques on renal function during
      the perioperative period of cardiac surgery in children.
    

Detailed description: 
      Acute kidney injury is one of the major complications after heart surgery, which increases
      the mortality of patients. Therefore, early prevention and detection of acute kidney injury
      is particularly important. In recent years, more and more studies have shown that both
      sevoflurane, an inhaled anesthetic widely used in clinical practice, and propofol, an
      intravenous anesthetic, have protective effects on kidneys. The aim of this study was to
      investigate the perioperative effects of two different anesthetic techniques on renal
      function for pediatric cardiac surgery.
    

Intervention name(s): inhalation anesthesia; Total intravenous anesthesia
Intervention type(s): Other; Other
Intervention description(s): sevoflurane was used to maintain anesthesia; propofol was used to maintain anesthesia
Intervention MeSH terms: Anesthetics
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        After approved by the ethics committee, sixty patients who met the inclusion criteria of
        this study with their parents' informed consent in Children's Hospital of Fudan University.
      
Keywords: propofol,sevoflurane
Cervical Repositioning Error in Chronic Migraine
Condition: Migraine; Chronic Migraine
MeSH terms: Migraine Disorders
Study type: Observational

Summary: 
      This study examines cervical joint position sense in individuals with chronic migraine vs.
      healthy controls. The ability to reposition the cervical spine after active movement will be
      evaluated in different head positions. Impaired proprioception and motor control is
      hypothesized in the migraine group.
    


Intervention name(s): Cervical Joint Repositioning Error Assessment
Intervention type(s): Diagnostic Test
Intervention description(s): The cervical joint repositioning error assessment is a non-invasive diagnostic test used to measure the ability of an individual to accurately reproduce a specific head position in different orientations (flexion, neutral position, 50% range of motion of left rotation, and 50% range of motion of right rotation). Participants in both the chronic migraine group and the control group will undergo this assessment using a digital inclinometer. The primary outcome of this study is the difference between the initial and repositioned cervical joint angles, measured in degrees.
Observational model: Other
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        The study population includes individuals aged 18-65 years old, with and without chronic
        migraine.
A Placebo-controlled Study of Levetiracetam In Children (1mo to 4yrs of Age) With Partial Onset Seizures.
Condition: Epilepsy, Partial
MeSH terms: Seizures; Epilepsies, Partial
Study type: Interventional
Phase: Phase 3

Summary: 
      To evaluate the safety and efficacy of levetiracetam used as adjunctive treatment in
      pediatric subjects age 1 month to less than 4 years with partial onset seizures. Subjects
      will be evaluated with 48 hour inpatient video electroencephalograms (a selection and an
      evaluation). Other neuropsychological clinical assessments will be performed during the 34
      day length of the study.
    


Intervention name(s): Levetiracetam; Placebo
Intervention type(s): Drug; Other
Intervention description(s): Dosing was stratified by age. A dose of 20 mg/kg/day titrating to 40 mg/kg/day for children one month to less than six months old and a dose of 25 mg/kg/day titrating to 50 mg/kg/day for children 6 month to less than 4 years old, was used in this study. The total daily dose was administered b.i.d.; Placebo solution, which is indistinguishable from the Levetiracetam oral solution.
Other intervention name(s): Keppra
Intervention MeSH terms: Levetiracetam
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Partial Onset Seizure; levetiracetam; Video Electroencephalogram; Keppra
Platform Switching vs Regular Platform Implants. One Year Results From a RCT
Condition: Missing Teeth
MeSH terms: Tooth Loss; Anodontia
Study type: Interventional

Summary: 
      The present study tested the hypothesis that Platform Switching (PS) and Regular Platform
      (RP) implants would have different outcomes in the bilateral single tooth replacements
      against the alternative hypothesis of no difference.
    

Detailed description: 
      This study was designed as a randomised, controlled, split-mouth trial. Eighteen patients,
      with bilaterally missing single bicuspid or molar had one of the sites to be restored
      randomly assigned to be treated according to the platform-switching concept with (PS group),
      or with matching implant-abutment diameters, (RP group). A total of 36 implants, (18 Nobel
      Replace Tapered Groovy PS, 18 Nobel Replace Tapered Groovy), were bilaterally installed. All
      the implants were inserted with an insertion torque between 35 and 45 Ncm, in healed healthy
      bone and the healing abutment was connected at the same time. Both implants were delayed
      loaded with screw retained temporary crowns 3 months after implant insertion and with screw
      retained definitive crowns 2 months later. Outcome measures were implant survival, biological
      and prosthetic complications, radiographic marginal bone-level changes, soft tissue
      parameters (PPD and BOP). Clinical data were collected at baseline 6 and 12 months.
      Statistical analyses were conducted using computational program SAS (version 9.2), with
      1-away ANOVA and F-test. Statistical significance was tested at the 0.05 probability level,
      and all values were presented as mean and standard deviation with 95% confidence intervals.
    

Intervention name(s): Nobel Replace Tapered Groovy implant; (Nobel Biocare®, Sweden)
Intervention type(s): Device
Intervention description(s): Both sites received tapered implants with an anodised surface, one site received: Nobel Replace Tapered Groovy PS implant; (Nobel Biocare, Goteborg, Sweden), with diameters of 4.3 or 5.0 mm and lengths of 10 or 8 mm, (PS group), the contralateral site received Nobel Replace Tapered Groovy implant with Replace Select connection with diameters of 4.3 or 5.0 mm and lengths of 10 or 8 mm, (RP group).
Healing abutments were connected to implants at the same time of surgery , then flaps were sutured with Vicryl 4.0 sutures (Vicryl, Ethicon J&J International, St-Stevens-Woluwe, Belgium).
Other intervention name(s): Nobel Replace Tapered Groovy PS implant; (Nobel Biocare®, Sweden); Nobel Replace Tapered Groovy implant with Replace Select connection (Nobel Biocare®, Sweden)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Platform Switching vs Regular Platform