bioihbjkbjnl/mcl2 huggingface dataset:
Evaluation of Oncoxin-Viusid® in Cervical Cancer and Endometrial Adenocarcinoma.
Condition: Cervical Carcinoma Stage II; Cervical Carcinoma Stage III; Cervical Carcinoma Stage IV; Endometrial Adenocarcinoma Stage II; Endometrial Adenocarcinoma Stage III; Endometrial Adenocarcinoma Stage IV
MeSH terms: Carcinoma; Adenocarcinoma; Uterine Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the efficacy of oral solution Oncoxin-Viusid in the
      reduction of acute toxicity of Radiotherapy (RTP) and Chemotherapy (QTP) in patients with
      histological diagnosis of cervical cancer and endometrial adenocarcinoma. This is a phase II,
      prospective, randomized and double blind clinical trial, which will include 66 patients
      assigned to 2 treatment arms: 33 patients will receive conventional treatment, plus a placebo
      of the nutritional supplement and another 33 patients will receive along with the
      conventional treatment the Oncoxin-Viusid nutritional supplement produced by the Catalysis
      Laboratories of Spain. Patients will receive oral treatment throughout the onco-specific
      treatment and up to 3 weeks after completion.
    

Detailed description: 
      Patients will be evaluated clinically and hematological at the beginning of the treatment,
      before each cycle of treatment with QTP / RTP, at month, two and three months after the end
      of the treatment with follow-up every three months for 1 year. The self-perceived quality of
      life related to health will be assessed by means of the EORTC questionnaires (QLQ-C30 and the
      specific questionnaire QLQ-CX24) at the beginning and a year after completing the treatment.
      The toxicity to the research product will be described according to Common Criteria of
      Terminology for the Report of Adverse Events (CTCAE version 4) and the tolerance to
      onco-specific treatment. It is expected that with the joint administration of the research
      product, the patients will have a better tolerance to the treatment of QTP / RTP with a
      decrease of the interruptions by toxicity in 25% and will preserve a better quality of life.
    

Intervention name(s): Oncoxin-Viusid®; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Administration of the Oncoxin-Viusid® oral solution 25 mL three times a day during the concurrent Radiotherapy and Chemotherapy treatment and up to 3 weeks after the end of the onco-specific treatment; Administration of the Oncoxin-Viusid® oral solution placebo 25 ml three times a day during the concurrent Radiotherapy and Chemotherapy treatment and up to 3 weeks after the end of the onco-specific treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Supportive Care
Keywords: Cervical carcinoma; Endometrial adenocarcinoma; Oncoxin-Viusid; Nutritional supplement; Antioxidant
Microwave Diathermy for Treating Nonspecific Chronic Neck Pain
Condition: Neck Pain
MeSH terms: Neck Pain; Hyperthermia
Study type: Interventional

Summary: 
      This randomised controlled trial aims to compare the effect of microwave diathermy
      (continuous and pulsed modes) with sham microwave diathermy in nonspecific chronic neck pain
      patients. Every patient will also be treated by exercise and transcutaneous electrical
      neurostimulation (TENS). The primary endpoint is to establish whether the use of microwaves
      is justified in terms of pain relief or reduction of disability in this patients.
    


Intervention name(s): Continuous microwave; Pulsed microwaves; Sham microwaves
Intervention type(s): Radiation; Radiation; Procedure
Intervention description(s): Continuous microwave through a great circular electrode, 15 cm from the neck, 20 minutes, 80 watts, 15 sessions in 3 weeks; Pulsed microwaves through a great circular electrode, 15 cm away from the neck, 20 minutes, 80 watts, 15 sessions in 3 weeks; Unplugged microwave generator, great circular electrode, 15 cm away from the neck, 20 minutes, 15 sessions in 3 weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Diathermy; Neck Pain
Integrated Eye Tracking and Neural Monitoring for Enhanced Assessment of Mild TBI: Primary Study
Condition: Mild Traumatic Brain Injury
MeSH terms: Brain Injuries; Brain Injuries, Traumatic; Brain Concussion
Study type: Observational

Summary: 
      This study was conducted to develop and validate integrated eye tracking and EEG measures for
      assessment of mild traumatic brain injury.
    


Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Participants will be recruited through USUHS, the Walter Reed National Military Medical
        Center, the National Intrepid Center of Excellence, Malcolm Grow Medical Center, the
        Washington DC VA Medical Center, VA outpatient treatment centers and Vet Centers in the
        greater Washington, D.C. area, Fort Belvoir, Fort Detrick and Fort Meade, public areas in
        the surrounding community, and in clinical settings such as such as concussion clinics,
        neurorehabilitation centers, and other local private practices.
      
Keywords: Traumatic brain injury, concussion, eye tracking, EEG, fMRI, DTI, Neurocognition
First in Human Study for Safety and Tolerability of AL003.
Condition: Healthy; Alzheimer Disease
MeSH terms: Alzheimer Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a multi-center, randomized, double-blind, placebo-controlled, dose escalation first
      in human (FIH) study in healthy adults and in patients with mild to moderate Alzheimer's
      disease. The study is designed to systematically assess the safety (including immunogenicity)
      and tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of AL003.
    

Detailed description: 
      The study will be conducted in 2 phases:

      In the single ascending dose (SAD) phase, up to approximately 42 healthy adult participants
      will be sequentially enrolled into up to approximately 7 cohorts. In the multiple-dose (MD)
      phase, approximately 12 patients with mild to moderate Alzheimer's disease will be enrolled
      in one cohort.
    

Intervention name(s): AL003; Saline Solution
Intervention type(s): Biological; Other
Intervention description(s): Single-doses of AL003 in dose-escalating cohorts
Multiple doses of AL003 in a single cohort; Saline Solution will be administered as a single infusion for each dose escalation cohort in a ratio of 6 active and 2 placebo and as multiple infusions in the single cohort in a ratio of 10 active and 2 placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Identification of Neuromas by High Resolution Ultrasound in Patients With Peripheral Nerve Injury and Amputations
Condition: Neuropathic Pain; Neuroma
MeSH terms: Neuroma; Neuralgia; Peripheral Nerve Injuries
Study type: Observational

Summary: 
      Neuromas are frequent after trauma and surgery, including amputation and can be identified by
      high-resolution ultrasound. The role of neuromas as the cause of neuropathic pain is
      uncertain. In this observational cohort study, the investigators wish to explore if the
      prevalence of neuromas are higher in patients with pain after peripheral nerve injury and
      amputation, than in patients with the same conditions but without pain.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients with peripheral nerve injury after surgery or trauma. Amputees.
Tension Type Headache, Myofascial Release Therapy , Post Isometric Relaxation Technique
Condition: Neck Pain
MeSH terms: Tension-Type Headache; Headache; Neck Pain
Study type: Interventional

Summary: 
      COMPARATIVE EFFECTS OF MYOFASCIAL RELEASE THERAPY AND POST ISOMETRIC RELAXATION TECHNIQUE ON
      PAIN AND FUNCTIONAL DISABILITY IN PATIENTS WITH TENSION-TYPE HEADACHE
    

Detailed description: 
      Tension-type headache (TTH) is the most common type of primary headache, typically presenting
      as a bilateral, non-throbbing headache with mild to moderate intensity. Patients with
      tension-type headache often report band-like tightness and increased tenderness of the
      pericranial muscles. Use of myofascial release technique and post isometric relaxation
      technique is believed to reduce the pain and improve the functional disability.
    

Intervention name(s): Myofascial release therapy therapy; Post isometric relaxation technique
Intervention type(s): Other; Other
Intervention description(s): Group A was treated with myofascial release therapy and routine physical therapy. For routine physical therapy subjects will first applied TENS, hot pack and neck isometric exercises then myofascial release therapy will be given. For myofascial release therapy subjects was in the supine or possibly sitting position, the examiner was seated at the head of the table, the examiner was used his right thumb to palpate (using flat palpation) the upper trapezius muscles from medial to lateral to establish if any MTrPs are present. The entire mass of the upper trapezius muscle is lifted by the supraspinatus muscle and grasped with a pincer grasp. The muscles at this point rotate between the thumb and forefinger to detect the delicate location of the trigger point. Treatment session longs for 10 minutes of myofascial release on each side; This group will receive routine physical therapy with myofascial release therapy.This protocol will be given for 3 alternative days per week. Each session will be of 40 minutes. Data will be calculated at baseline , at 2nd and at 4th week.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: To compare the effects of myofascial release therapy and post isometric relaxation technique on pain and functional disability in patients with tension type headache
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Myofascial release therapy
Evaluation of Daily Disposable Silicone Hydrogel Multifocal Toric Contact Lenses
Condition: Visual Acuity
Study type: Interventional

Summary: 
      The study is a bilateral, single-masked, single-arm, 4-visit dispensing study. There will be
      one study treatment, with the subject being dispensed lenses for 6 to 8 days, then lens power
      will be optimized (if necessary) and dispensed for a further 2 weeks to assess the clinical
      performance of investigational multifocal toric contact lenses.
    


Intervention name(s): JJVC Investigational Multifocal Toric Contact Lens
Intervention type(s): Device
Intervention description(s): TEST
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Study to Evaluate Drug-drug Interactions and Safety Between "BR3006-1", "BR3006-2", and "BR3006-3" in Healthy Volunteers
Condition: Diabetes Mellitus
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this clinical trial is to evaluate drug-drug interactions and safety between
      "BR3006-1", "BR3006-2", and "BR3006-3" in healthy volunteers
    

Detailed description: 
      A total of 36 subjects will be randomized into 6 sequence groups, 6 subjects per sequence
      group. The Investigational Products wil be according to the treatment group (A,B,C,D,E,F)
      assigned to each sequence group in Period 1, Period 2 and Period 3.
    

Intervention name(s): BR3006-1; BR3006-2; BR3006-3
Intervention type(s): Drug; Drug; Drug
Intervention description(s): All subjects who have been fasting for at least 10 hours prior to administration will take investigational products orally with 150 mL of water at room temperature at around 8 a.m. on the administration day of each period.; All subjects who have been fasting for at least 10 hours prior to administration will take investigational products orally with 150 mL of water at room temperature at around 8 a.m. on the administration day of each period.; All subjects who have been fasting for at least 10 hours prior to administration will take investigational products orally with 150 mL of water at room temperature at around 8 a.m. on the administration day of each period.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
The Effect of Oxymetazoline Gel on Anal Pressure and Incontinence in Spinal Cord Injury Patients
Condition: Fecal Incontinence; Spinal Cord Injury
MeSH terms: Fecal Incontinence; Spinal Cord Injuries; Wounds and Injuries
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This is an double blinded, cross-over study to determine the effect of Oxymetazoline gel on
      anal resting pressure and fecal incontinence in patients with spinal cord injury.
      Approximately 17 subjects are expected to complete this 10 weeks study that will include two
      treatment periods of 4 weeks each, and one 2 weeks wash out period.
    


Intervention name(s): Oxymetazoline gel; Placebo gel
Intervention type(s): Drug; Drug
Intervention description(s): Oxymetazoline gel applied intra-anally once daily; Placebo gel applied intra-anally once daily
Intervention MeSH terms: Phenylephrine; Oxymetazoline
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
A Multi-Site Study of Music Therapy Interventions on Vitals, Feeding and Sleep in Premature Infants
Condition: Prematurity; Sepsis; SGA; RDS
MeSH terms: Premature Birth
Study type: Interventional

Summary: 
      This is a multi-site study of 272 premature infants >32 weeks who served in a randomized
      investigation (in morning or afternoon) where they served as their own controls. The infants'
      HR, RR, O2sats were measured with and without the implementation fo live music. The live
      interventions included songs of kin, selected by parents, the gato box and ocean disc played
      through entrained methods by a music therapist. The infants were evaluated within a two week
      period and in total each day including feeds, voids, activity level and sleep.
    


Intervention name(s): Music Intervention; Music
Intervention type(s): Other; Other
Intervention description(s): Applied by randomization-live at bassinet in the AM or PM Gato Box, Ocean Disc or parent-selected lullabies; Remo Ocean disc Gato box Music therapist's or Parent's preferred lullaby or 'Twinkle'
Other intervention name(s): Remo Ocean disc; Gato box; Music therapist's or Parent's preferred lullaby or 'Twinkle'
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: music therapy; entrainment; premature infants; live music intervention; parent preferred lullabies
A Comparative Study to Evaluate the Effects and Mechanism of Action of Dysport®, Botox® and Xeomin® in the Extensor Digitorum Brevis Model in Healthy Adult Male Participants
Condition: Healthy Participants
Study type: Interventional
Phase: Phase 1

Summary: 
      Study aimed at comparing the pharmacodynamic profile (including duration of action) of three
      commercialized toxins by measuring the action potential of the injected muscle (extensor
      digitorum brevis)
    


Intervention name(s): Botulinum toxin type A; Botulinum toxin type A; Botulinum toxin type A
Intervention type(s): Biological; Biological; Biological
Intervention description(s): Intramuscular Injection, concentration 300 units (U); Intramuscular Injection, concentration 50 U; Intramuscular Injection, concentration 50 U
Other intervention name(s): abobotulinumtoxinA (Dysport®); onabotulinumtoxinA (Botox®); incobotulinumtoxinA (Xeomin®)
Intervention MeSH terms: Botulinum Toxins; Botulinum Toxins, Type A; abobotulinumtoxinA; incobotulinumtoxinA
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
The Protective Effect of Friendship on Peer Rejection in Overweight and Normal Weight Youth
Condition: Social Exclusion; Control
MeSH terms: Overweight
Study type: Interventional

Summary: 
      This study examines youth's motivation for food or social rewards after a brief episode of
      simulated ostracism. The investigators hypothesize that youth who think about a friend after
      being ostracized will mediate their decision to resort to food, which is typically evidenced
      in socially isolated overweight youth.
    


Intervention name(s): Ostracism
Intervention type(s): Behavioral
Intervention description(s): Participants would received the ball of a computerized ball-tossing game once or twice in the beginning and then never again for the duration of the game.
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Single (Participant)
The Clinical Trial Protocol for the Inactivated Poliomyelitis Vaccine Made From Sabin Strains
Condition: Poliomyelitis
MeSH terms: Poliomyelitis
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the safety and the immunogenicity of Inactivated
      Poliomyelitis Vaccine made from Sabin Strains by different does.
    

Detailed description: 
      The Sabin IPV was manufactured with poliovirus type1, 2, 3 Sabin strains and Vero cells by
      micro-carrier culture in 550 liter bioreactors. The virus suspension was harvested
      ,ultra-concentrated, purified and inactivated with formalin. Three formulations A,B,C of
      Sabin IPV were used, the DAg contents for A were type1 45,type2 64,type3 67.5 DU /0.5ml/per
      dose; for B 30,32,45 DU/0.5ml/per dose; for C 15,16,22.5 DU/0.5ml/per dose.

      This is a randomized, double-blind, placebo control phase 1 clinical trial. Total 130
      individuals were selected ,including adults (n=20), children(n= 20) and infants(n= 90).
      Adults were randomized to two groups A1(n=10) and A2(n=10).Group A1 received one dose of B
      ,one month later group A2 received one dose of A for safety observation. Children were
      randomized to two groups C1(n=10) and C2(n=10) and followed the same vaccination and safety
      observation procedures as adults. Infants were randomly allocated to three groups I-1,I-2,I-3
      for safety and immunogenicity study. Group I-1 were vaccinated with three doses of C(n=15) or
      placebo (n=15) on day 0,30,60,serum samples were collected before and 30 days after dose 3
      for detecting neutralization antibody. The same procedures were followed by GroupI-2 for B
      and group I-3 for A as groupI-1 with 30 days intermission.
    

Intervention name(s): Inactivated Poliomyelitis Vaccine (Sabin strains); Inactivated Poliomyelitis Vaccine (Sabin strains); Inactivated Poliomyelitis Vaccine (Sabin strains)
Intervention type(s): Biological; Biological; Biological
Intervention description(s): 15 infants received 3 doses of formulation C vaccine and 15infants received 3 doses of placebo 3x0.5ml intramuscular injections, one month apart.; 15 infants received 3 doses of formulation B vaccine and 15infants received 3 doses of placebo 3x0.5ml intramuscular injections, one month apart;; 15 infants received 3 doses of formulation A vaccine and 15infants received 3 doses of placebo 3x0.5ml intramuscular injections, one month apart.
Other intervention name(s): Sabin IPV,lot No.20080303; Sabin IPV, lot No.20080302; Sabin IPV, lot No.20080301
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Inactivated Poliomyelitis Vaccine; Sabin Strains; poliomyelitis
Use of EMG to Assess Clinical Hypertonia
Condition: Cerebral Palsy; Hypertonia; Spasticity; Dystonia; Rigidity
MeSH terms: Cerebral Palsy; Dystonia; Muscle Hypertonia
Study type: Observational

Summary: 
      A handheld surface electromyography device will be tested by clinicians on children with limb
      hypertonia, and inter-rater reliability will be assessed with and without the device.
    

Detailed description: 
      Hypothesis:

      Qualitative surface EMG measurement during passive movement will increase the inter-rater
      reliability of clinicians for diagnosis of spasticity and dystonia in children with
      hypertonia.

      Specific Aims:

        1. Develop a handheld surface EMG device with auditory output that can be used similarly to
           a stethoscope to listen non-invasively to the activity of muscles.

        2. Provide clinicians at 5 different institutions with a device to test for 2 months in
           their own clinics.

        3. Bring all 5 clinicians to Stanford University for a single-day exercise in which each
           clinician will examine 10 children with hypertonia. Each clinician will rate the
           children without using the device, and then again with the device. Intra-class
           correlations and kappa statistics will be used to assess whether the use of the device
           leads to improved inter-rater reliability.
    

Intervention name(s): portable surface electromyography
Intervention type(s): Device
Time perspective: Prospective
Keywords: Hypertonia; Childhood
A Study of CAN008 for Newly Diagnosed Glioblastoma Multiforme
Condition: Glioblastoma Multiforme
MeSH terms: Glioblastoma
Study type: Interventional
Phase: Phase 1

Summary: 
      To evaluate CAN008 safety, tolerability, and pharmacokinetics (PK) of CAN008 when
      administered concurrent Plus Concomitant Temozolomide During and After Radiation Therapy in
      Patients with Newly Diagnosed Glioblastoma Multiforme.
    

Detailed description: 
      CAN008 is a glycosylated fusion protein consisting of the extracellular domain of human CD95
      (APO-1/Fas) and the Fc domain of human IgG1. CAN008 blocks the interaction between CD95 and
      its cognate ligand CD95L. The target of CAN008 is the inhibition of CD95L. CD95L is expressed
      in glioblastoma whose cells are resistant to CD95-mediated apoptosis. CD95L was shown to be a
      crucial trigger in invasion and migration of tumor cells and neutralizing CD95L abolishes the
      invasive capacity of glioblastoma cells.

      The purpose of the study is:

        1. To describe the toxicity associated with this regimen in adult patients with newly
           diagnosed glioblastoma multiforme.

        2. To determine the duration of disease free survival and overall survival associated with
           this therapy.
    

Intervention name(s): CAN008
Intervention type(s): Drug
Intervention description(s): The dose escalation in the phase I study including 200mg in the first cohort and 400mg in the second cohort to Recommended for Phase 2 Dose (RP2D)
Other intervention name(s): APG101
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment