bioihbjkbjnl/mcl2 huggingface dataset:
Topical Radial Artery Vasodilation
Condition: Cardiac Catheterization; Spasm
MeSH terms: Spasm
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The aim of the study is to facilitate radial artery access for cardiac catheterization. The
      investigators hypothesize that topical nitroglycerin and lidocaine will reduce radial artery
      spasm. Patients undergoing cardiac catheterization via the radial artery will be randomized
      to topical nitroglycerin + lidocaine versus placebo.
    

Detailed description: 
      The aim of the study is to facilitate radial artery access for cardiac catheterization. The
      investigators hypothesize that topical nitroglycerin and lidocaine will reduce radial artery
      spasm. Patients undergoing cardiac catheterization via the radial artery will be randomized
      to topical nitroglycerin + lidocaine versus placebo.
    

Intervention name(s): Nitroglycerin and lidocaine; Placebo
Intervention type(s): Drug; Other
Intervention description(s): Topical Nitroglycerin and lidocaine; Placebo
Intervention MeSH terms: Lidocaine; Nitroglycerin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: radial artery spasm
Post-marketing Study to Evaluate the Effect of Mirabegron on the Plasma Concentration of Tolterodine
Condition: Pharmacokinetics of Mirabegron and Tolterodine; Healthy
Study type: Interventional
Phase: Phase 4

Summary: 
      To assess the effect of multiple doses of mirabegron to postmenopausal adult female subjects
      on the pharmacokinetics (PK) of tolterodine and its metabolites.

      In addition, the safety of these products will be assessed.
    


Intervention name(s): tolterodine; mirabegron
Intervention type(s): Drug; Drug
Intervention description(s): Oral; Oral
Other intervention name(s): Detrusitol® Capsules; YM178; Betanis® tablets
Intervention MeSH terms: Mirabegron; Tolterodine Tartrate
Intervention model: Single Group Assignment
Masking: None (Open Label)
Keywords: Open-label design; Pharmacokinetics; Drug-Drug Interaction; Mirabegron
Preoperative Imaging in Retroperitoneal Sarcoma
Condition: Cancer
MeSH terms: Sarcoma
Study type: Observational

Summary: 
      This is a prospective observational study in which patients with untreated retroperitoneal
      sarcoma will have Magnetic Resonance Imaging (MRI) prior to surgery. In addition, patients
      who will be undergoing pre-operative radiotherapy will have an additional MRI scan at two
      weeks post radiotherapy. For both groups, the magnetic resonance images will be correlated
      with tumour pathology.

      The study hypothesis is that Magnetic Resonance Imaging will provide a more accurate
      assessment of tumour volume and local staging than CT and will identify areas of altered
      oxygenation, cellularity and perfusion which change in response to radiotherapy before tumour
      shrinkage occurs.
    


Intervention name(s): Magnetic Resonance Imaging
Intervention type(s): Procedure
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Patients with retroperitoneal sarcoma randomised for preoperative radiotherapy plus surgery
        versus surgery alone.
      
Keywords: Retroperitoneal Sarcoma; Magnetic Resonance Imaging
Robot Assisted Gait Training In Children With Cerebral Palsy
Condition: Cerebral Palsy; Physical Therapy; Robotic Rehabilitation; Motor Skills Disorders
MeSH terms: Paralysis; Cerebral Palsy; Motor Skills Disorders
Study type: Interventional

Summary: 
      Cerebral Palsy (CP) is considered a neurological disorder caused by a non-progressive brain
      injury or malformation that occurs while the child's brain is under development. CP primarily
      affects body movement and muscle coordination. Robot assisted gait training (RAGT) is
      considered to be a promising approach for improving gait related gross motor function of
      children and youth with CP.

      There is weak and inconsistent evidence regarding the use of RAGT for children with gait
      disorders. Further research is required with increased numbers and with relevant outcome
      measures to both confirm the effectiveness and clarify training schedules.

      The aim of this research project is to investigate the effectiveness of robot assisted gait
      training on improvements of functional gait parameters in children with cerebral palsy.
    

Detailed description: 
      Cerebral Palsy (CP) is a disorder of posture and movement due to a defect in the immature
      brain. There is evidence that locomotor therapy for regaining walking capacity using the
      principle of enhancing neuroplasticity by task-specific training is effective in the
      rehabilitation process of patients with central gait disorders. The use of a robotic device
      assists in achieving and maintaining physiological walking pattern for extended periods of
      therapy. The use of robotic devices as an alternative treatment to improve the gait function
      in patients with CP has increased.

      This is a prospective, randomized comparative trial (RCT). This study is designed to compare
      the effectiveness of conventional physical therapy (CPt) and robot assisted gait training
      (RAGT) on gait related motor skills of children with cerebral palsy.

      Children aged 5 to 18 years with GMFCS Level 2-4, bilateral or unilateral spastic CP are
      accepted into this study. Participants are randomly assigned to receive CPt or RAGT + CPt.

      All two intervention groups will receive 2-3 sessions of CPt per week over 6-8 weeks. CPt
      sessions are individually customized to the needs of the child.

      The participants of RAGT + CPt group also receive 15 sessions of RAGT (2-3 times per week
      with a maximum of 45 minute each).
    

Intervention name(s): Robot assisted gait training; Conventional physiotherapy
Intervention type(s): Device; Other
Intervention description(s): 15 sessions of robot-assisted gait training (two times per week with a maximum of 45 minute each).; individually customized to the needs of the child and usually consists of 2-3 sessions of physiotherapy per week.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Cerebral Palsy, Robot assisted gait training, Gait
Maintenance Interpersonal Psychotherapy for Sustaining Remission of Depression
Condition: Depression
MeSH terms: Depression; Depressive Disorder
Study type: Interventional

Summary: 
      This study will evaluate the effectiveness of maintenance interpersonal psychotherapy (IPT)
      in preventing relapse of depression in women who have required combined psychotherapy and
      pharmacotherapy treatment to obtain a remission of depression symptoms.
    

Detailed description: 
      Depression is a serious medical illness that can recur more than once in a person's lifetime.
      Effective treatment methods are needed to maintain a state of remission in people who have
      had prior episodes of depression. IPT is a brief and highly structured type of psychotherapy
      that addresses interpersonal issues associated with depression. Previous studies have shown
      that it is an effective method for treating depression. This study will evaluate the
      effectiveness of maintenance ITP in preventing relapse of depression in women who have
      required combined psychotherapy and pharmacotherapy treatment to obtain remission of
      depressive symptoms.

      Participants in this open label study will be recruited from a previous study, "Maintenance
      Psychotherapy in Recurrent Depression: Study I." In this study participants will initially
      receive weekly sessions of IPT as well as medication treatment with fluoxetine. Any
      participants who do not reach remission of depressive symptoms after 6 weeks will be given
      other standard treatments for depression. Once remission of depressive symptoms is reached,
      participants will continue receiving weekly IPT and fluoxetine treatment for 20 weeks. After
      20 weeks, fluoxetine treatment will be discontinued, and all participants will receive IPT
      alone for 6 weeks before entering the maintenance phase of the study. Upon entrance into this
      phase, participants will be randomly assigned to receive IPT weekly, biweekly, or monthly for
      18 months. Functioning and depressive symptoms will be assessed at Month 24.
    

Intervention name(s): Interpersonal Psychotherapy; Fluoxetine
Intervention type(s): Behavioral; Drug
Intervention MeSH terms: Fluoxetine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Depression Relapse; Maintenance Therapy
Non Invasive Ventilation Comfort Study
Condition: Healthy
Study type: Interventional

Summary: 
      Patients who are suffering from a variety of respiratory conditions benefit from continuous
      positive airway pressure (CPAP) which is a form of Non-Invasive Ventilation (NIV). Some
      patients find the temperature of the breathing gas difficult to tolerate. The aim of this
      study is to compare comfort of healthy volunteer participants while being given CPAP at
      different temperatures.
    

Detailed description: 
      Patients who are suffering from a variety of respiratory conditions benefit from continuous
      positive airway pressure (CPAP) which is a form of Non-Invasive Ventilation (NIV). Some
      patients find the temperature of the breathing gas difficult to tolerate. The aim of this
      study is to compare comfort of healthy volunteer participants while being given CPAP at
      different temperatures. Healthy volunteers will be given two different levels humidity and
      temperature and asked about preference.
    

Intervention name(s): CPAP
Intervention type(s): Device
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: CPAP
Pilot Trial of Bavituximab Combined With Ribavirin for Initial Treatment of Chronic HepC Virus Genotype 1 Infection
Condition: Hepatitis C
MeSH terms: Hepatitis C; Hepatitis
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This will be a randomized, open-label, active-control Phase II pilot trial of bavituximab
      combined with ribavirin for initial treatment of chronic HCV genotype 1 infection. Eligible
      patients with normal coagulation, hematological, and renal function will undergo a
      screening/washout period of up to 28 days, followed by randomization to receive weekly
      bavituximab or PEG-IFN alpha-2a therapy for 12 weeks, both with twice-daily ribavirin.

      The primary endpoint of this study is the proportion of patients who show a greater than or
      equal to 2-log10 IU reduction in plasma HCV RNA level after 12 weeks of treatment (early
      virological response; EVR).

      Secondary endpoints include the proportion of patients with an undetectable HCV RNA level
      after 12 weeks of treatment; the proportion of patients who show a reduction in HCV RNA level
      of greater than or equal to 2 log10 IU after 4 weeks of treatment, viral kinetics for
      individual patients over time, and comprehensive evaluation of the safety and tolerability of
      bavituximab infusion.
    

Detailed description: 
      Primary Objective: The primary objective of this study is to assess the effect of 12 weeks of
      initial treatment with bavituximab versus PEG-IFN, each combined with ribavirin, on plasma
      HCV RNA level in patients with chronic HCV genotype 1 infection.
    

Intervention name(s): Bavituximab; Pegylated interferon (PEG-IFN)
Intervention type(s): Drug; Drug
Intervention description(s): Bavituximab 3 mg/kg given by intravenous (IV) infusion once weekly, plus oral ribavirin 1000 mg (weight <75 kg) or 1200 mg (weight greater than or equal to 75 kg) divided into twice-daily doses, for 12 weeks or
Bavituximab 0.3 mg/kg given by IV infusion once weekly, plus oral ribavirin 1000 mg (weight <75 kg) or 1200 mg (weight greater than or equal to 75 kg) divided into twice-daily doses, for 12 weeks or; Pegylated interferon (PEG-IFN) alpha-2a 180 micrograms given by subcutaneous (SC) injection once weekly, plus oral ribavirin 1000 mg (weight <75 kg) or 1200 mg (weight greater than or equal 75 kg) divided into twice-daily doses, for 12 weeks
Other intervention name(s): Bavituxmab; Pegasys
Intervention MeSH terms: Interferons; Bavituximab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Enhancing STDP After Spinal Cord Injury
Condition: Spinal Cord Injury
MeSH terms: Spinal Cord Injuries; Wounds and Injuries
Study type: Interventional

Summary: 
      The overall goal is to develop new clinical approaches to restore limb function after spinal
      cord injury (SCI). Corticospinal tract (CST) axons are involved in controlling limb function.
      Paired pulse induced spike-timing dependent plasticity (STDP) enhances synaptic strength
      between residual CST axons and spinal motoneurons (SMNs) resulting in temporary improvements
      in limb function in humans with incomplete SCI. Motor training will be combined with
      paired-pulse STDP stimulation to further enhance plasticity and behavioral recovery.
    

Detailed description: 
      To induce STDP with paired pulse, corticospinal volleys evoked by either transcranial
      magnetic stimulation over the primary motor cortex for upper extremities or electrical
      stimulation over the thoracic spine for lower extremities arrive at corticospinal-motor
      neuronal synapses of upper- or lower-limb muscles, 1-2 ms before antidromic potentials were
      elicited in motor neurons by electrical stimulation of corresponding peripheral nerves.
    

Intervention name(s): STDP; Training; Sham STDP; Multisite-STDP
Intervention type(s): Other; Behavioral; Other; Other
Intervention description(s): Paired stimulation will be given to the brain and to a peripheral nerve so that the messages are received at the spinal cord at predetermined time.; The participant will be asked to perform exercises using their hands and arms.; Sham or fake paired stimulation will be given to the brain and to a peripheral nerve so that the messages are received at the spinal cord at predetermined times.; Paired stimulation will be given to the brain bilaterally, thoracic spine, and several peripheral nerve so that the messages are received at the spinal cord at predetermined time.
Other intervention name(s): Paired stimulation
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: spike timing dependant plasticity
Periapical Healing After One or Two-visits to Endodontic Treatment in Adolescents Patients
Condition: Periapical Periodontitis
MeSH terms: Periodontitis; Periapical Periodontitis
Study type: Interventional

Summary: 
      The main objective of this study is the prevention and repair of apical periodontitis in
      lower molars with pulp necrosis after the execution of endodontic treatment in one or two
      visits in adolescent patients. Moreover, it is also observed the frequency of postoperative
      pain in endodontic treatment.
    

Detailed description: 
      This project is developed in adolescent patients who have need of endodontic treatment in
      necrotic molars. The patients were randomly divided into two groups of treatment: one and two
      visits. The treatment protocol is the same for both groups, except the number of visits and
      the use of intra canal medication in the group treated in two visits. Patients will be
      followed clinically and radiographically for a minimum period of two years. The data was
      collected by the evaluation of postoperative pain and to determine the healing of periapical
      lesions, characterizing the success of the treatment.
    

Intervention name(s): Root canal therapy in one visit; Root Canal Therapy in two-vist
Intervention type(s): Procedure; Procedure
Intervention description(s): Patient was anesthetized with local anesthetic solutions, and the caries was removed. The tooth was isolated with rubber dam and access to pulp chamber was completed. Cleaning and shaping preparation was achieved with manual and rotatory endodontic instruments.The ideal working length was determined by an electronic apex locator and periapical radiography. Irrigation was performed with 5.25%NaOCl solution. The smear layer was removed by 10% citric acid. The cases were obturated with guta-percha cones using a lateral compaction filling technique as well as zinc oxide-eugenol-based root canal sealer. The teeth filled with a light-cured resin.; The treatment protocol was the same as described for one visit group. In the first visit, after cleaning, shaping and smear layer removal, the root canals were medicated with a calcium hydroxide paste and sterile distilled water (1:1) and the pulp chamber was sealed with a minimum 3mm thickness temporary filling restoration. After 10-12 days, during the second visit, the medication was removed, and the cases were obturated with guta-percha cones using a lateral compaction filling technique as well as zinc oxide-eugenol-based root canal sealer. The teeth filled with a light-cured resin.
Other intervention name(s): One visit root canal treatment; Single visit; Multiple-visit of root canal treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Periapical Periodontitis; Dental Pulp Necrosis; Root canal Therapy; Adolescent
Kisspeptin/GPR54 Pathway and Early Puberty
Condition: Puberty, Precocious
MeSH terms: Puberty, Precocious
Study type: Observational

Summary: 
      There was a worldwide early trend in girls'age for puberty onset. The timing of puberty onset
      varies greatly among individuals, and much of this variation is modulated by genetic factors.
      This study was designed to explored the association of polymorphisms in KISS1/GPR54 pathway
      genes and the risk of early puberty in Chinese Han girls.
    


Intervention name(s): this study was an observational study and no interventions were given to the participants
Intervention type(s): Other
Intervention description(s): the participants were recruited and the data as well as blood sample were collected.
Observational model: Case-Control
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        Chinese Han girls from Shenzhen Children's Hospital or monitoring schools in Shenzhen
      
Keywords: SNP; kisspeptin; GPR54
Hip Related Functional Limitations in Individuals With Idiopathic Scoliosis
Condition: Scoliosis Idiopathic
MeSH terms: Scoliosis
Study type: Observational [Patient Registry]

Summary: 
      The aim of this study is to examine the functional parameters of hip and jaw in terms of
      scoliosis degree and scoliosis pattern in individuals with idiopathic scoliosis.
    

Detailed description: 
      In this study investigators will examine the hip functional parameters and jaw functional
      parameters separately.

      In hip study hip functional parameters will be evaluated for determining the correlation
      between scoliosis degree/pattern and hip functions.

      In jaw study jaw functional parameters will be evaluated for determining the correlation
      between scoliosis degree/pattern and hip functions.
    

Observational model: Case-Only
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Our study will include cases who applied to Hacettepe University, Faculty of Physical
        Medicine and Rehabilitation with a diagnosis of scoliosis, had anterior-posterior and
        lateral radiographs, accepted to participate in the study on a voluntary basis, were
        literate and cooperated in completing the scales. In cases under the age of 18, the
        evaluation will be started by obtaining additional family consent.
      
Keywords: scoliosis; hip; jaw; adolescent idiopathic scoliosis
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Ascending Oral Doses and Effect of Food on the Bioavailability of BI 1060469
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The objective of the single rising dose part (SRD) is to investigate safety, tolerability,
      pharmacokinetics, and pharmacodynamics of single rising doses of BI 1060469 in healthy male
      subjects. The objective of the food effect part (FE) is to investigate the relative
      bioavailability of BI 1060469 tablets in healthy male subjects in fed or fasted state.
    


Intervention name(s): Placebo to BI 1060469; BI 1060469; BI 1060469
Intervention type(s): Drug; Drug; Drug
Intervention description(s): single rising doses; food effect; single rising doses
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single
Primary purpose: Treatment
Evaluating the Impact of Baduanjin Exercise Intervention on Quality of Life in Breast Cancer Survivors Receiving Aromatase Inhibitor Therapy
Condition: Breast Cancer Survivors Receiving Aromatase Inhibitor Therapy
MeSH terms: Breast Neoplasms
Study type: Interventional

Summary: 
      A 12-week randomized controlled trail was conducted in 72 Chinese breast cancer survivors who
      had received aromatase inhibitors treatment for more than 6 months. All participants were
      assigned to either 12 weeks of Baduanjin classes which involved to two 90-minute sessions per
      week or a wait-list control. Participants completed fitness assessments, measurements of
      lipopolysaccharide-stimulated production of proinﬂammatory cytokines interleukin-6 (IL-6),
      tumor necrosis factor alpha (TNF-α), interleukin-1β(IL-1β) ,C-reactive protein (CRP) ，BMI，BMD
      and questionnaires to measure QoL, fatigue, sleep quality, Aromatase Inhibitor-Induced
      Arthralgia, symptoms of climacteric syndrome were completed at baseline and 3 months.
    


Intervention name(s): Baduanjin exercise
Intervention type(s): Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Other
Keywords: Breast Cancer; Aromatase Inhibitor Therapy; Baduanjin Exercise