bioihbjkbjnl/mcl2 huggingface dataset:
A Phase 2/3 Study of TVP-1012 at 0.5 mg or 1 mg in Levodopa Treated Parkinson's Disease Participants
Condition: Parkinson's Disease
MeSH terms: Parkinson Disease
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The purpose of this study is to evaluate the efficacy and safety of TVP-1012 (0.5 mg or 1
      mg/day) as an add-on to levodopa in Japanese participants with Parkinson's disease with
      wearing-off phenomenon.
    

Detailed description: 
      This is a multicenter, randomized, double-blind, placebo-controlled, parallel group, phase
      2/3 study to evaluate the efficacy and safety of TVP-1012 as an add-on to levodopa in
      Japanese participants with Parkinson's disease with wearing-off phenomenon.

      The study period consisted of a 28-week trial period. The participants who fulfilled the
      inclusion criteria and did not meeting any of the exclusion criteria were enrolled, and
      randomized in a 1:1:1 ratio to the 0.5 mg of TVP-1012, the 1 mg of TVP-1012, or the placebo
      group. In each treatment group, participants received 0.5 mg of TVP-1012, 1 mg of TVP-1012,
      or placebo once daily in a double-blinded manner.
    

Intervention name(s): TVP-1012 1mg; TVP-1012 0.5mg; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): TVP-1012 1mg Tablets; TVP-1012 0.5mg Tablets; Placebo Tablets
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Evaluation of the Rate of En-masse Retraction in Orthodontic Patients With Maxillary Protrusion
Condition: Bimaxillary Protrusion
Study type: Interventional

Summary: 
      There's a scarcity in literature concerning en-masse retraction and its effect on the rate of
      tooth movement. The purpose of this study is to determine, In orthodontic patients with
      maxillary protrusion, which form of mechanics in en-masse retraction offers a faster rate of
      retraction; Friction or Frictionless Mechanics.
    

Detailed description: 
      The en-masse technique can be done in one of two ways: through friction or frictionless
      mechanics. Both are viable options, but, ideally, we want to retract and complete the
      orthodontic treatment as quickly as possible, in order to decrease the negative effects that
      may occur during treatment. Which of these mechanics results in a decreased treatment time is
      still up for debate.
    

Intervention name(s): Power chain and Crimpable hook for En-Masse Retraction; T- Loop
Intervention type(s): Procedure; Procedure
Intervention description(s): Retraction will start on a 0.017"x0.025" Stainless steel wire using elastomeric chain (force applied will be 212 g per side) extending between the crimpable hooks and the miniscrew; Closing retraction T-loops will be fabricated using 0.017 x 0.025 TMA wire. The loop will be positioned halfway the extraction space and the canine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: En-masse Retraction; Friction; Fricitionless; Lateral Cephalometric; Rate; Dental Models
AZD1152 in Patients With Advanced Solid Malignancies
Condition: Tumors
MeSH terms: Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary purpose of this protocol is to investigate the safety and tolerability of AZD1152
      when given as a continuous 48-hour infusion every 14 days and as a 2-hour infusion for 2
      consecutive days every 14 days in patients with advanced solid malignancies.
    


Intervention name(s): AZD1152 part A; AZD1152 part B
Intervention type(s): Drug; Drug
Intervention description(s): 48-hour continuous intravenous infusion; 2-hour intravenous infusion
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Solid tumor
Pharmacokinetic Study of Interaction Between Nevirapine and Methadone in HIV-1 Infected, Opioid-dependent Adults
Condition: Acquired Immunodeficiency Syndrome
MeSH terms: Acquired Immunodeficiency Syndrome; HIV Infections; Immunologic Deficiency Syndromes
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study was to determine the effects of nevirapine treatment on the
      pharmacokinetics of methadone in HIV-1 infected, opioid-dependent adults who had been on a
      stable methadone maintenance therapy for at least five days prior to study entry.
    

Detailed description: 
      Ten HIV-1 infected, opioid-dependent adults on stable methadone treatment were to be enrolled
      in this study. This was an open-label, sequential treatment study, with methadone
      pharmacokinetics sampling before and after twenty-one (21) days of nevirapine administration.

      All patients received the same regimen. Methadone was administered in the first treatment
      period, and combination treatment of methadone and nevirapine was given in the second
      treatment period. In the first period, patients received methadone at their current steady
      state dose. In the second period (study days 1-21), they also received nevirapine 200mg qd
      (study days 1 to 14) and 200mg bid (study days 15 to 21). Blood samples were taken at the
      start of the first treatment period and at the end of the second treatment period for
      analysis of methadone and nevirapine pharmacokinetics parameters.

      Study Hypothesis:

      It was expected that nevirapine would decrease methadone levels in this patient population.

      Comparison(s):

      The study compared methadone steady state exposure in the absence and presence of steady
      state nevirapine. A range of pharmacokinetics parameters were assessed including clearance of
      methadone (the primary endpoint variable), area under the concentration-time curve, maximum
      concentration, time to maximum concentration and minimum concentration (measured for both
      methadone and nevirapine).
    

Intervention name(s): nevirapine
Intervention type(s): Drug
Intervention MeSH terms: Nevirapine
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Brain and Muscle Plasticity During Immobilization
Condition: Muscle Atrophy
MeSH terms: Muscular Atrophy
Study type: Interventional

Summary: 
      Patients in rehabilitation may undergo periods of prolonged limb immobilization in response
      to injury, surgery, or illness. Due to disuse, the size and strength of muscles controlling
      the affected limb can decrease significantly, possibly resulting in physical impairment or
      lower quality of life during the recovery phase. Prior immobilization studies have shown that
      the rate and degree of decline in muscle strength exceeds that of muscle size, indicating
      that determinants of muscle strength unrelated to muscle size may further contribute to
      functional changes during immobilization.

      The purpose of this study is to describe the changes in muscle strength, muscle size,
      corticospinal excitability, voluntary activation, M1 cortical thickness, and resting state
      functional connectivity following a 2-week limb immobilization period in young women.
    


Intervention name(s): Immobilization
Intervention type(s): Behavioral
Intervention description(s): Immobilization of left arm using a brace and sling.
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Diet and Behavior in Young Children With Autism
Condition: Autism; Autistic Disorder
MeSH terms: Autistic Disorder
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will determine whether a gluten- and casein-free diet has specific benefits for
      children with autism.
    

Detailed description: 
      Autism is a serious brain disorder that affects brain development and often causes social and
      educational problems. Prior studies suggested that a gluten- and casein-free diet may have a
      therapeutic effect on the behavior of children with autism. This study will examine the
      effects of such a diet on the behavior of children with autism who meet research diagnostic
      criteria, are monitored in adherence to the diet, and receive similar intense behavioral
      therapy.

      Children in this study will be following a gluten free and casein free diet for 18 weeks. All
      subjects will have 6 weeks of baseline followed by 12 weeks of randomized, double-blind,
      placebo-controlled, challenge snacks with careful behavioral observation and evaluation. They
      also will be receiving uniform educational and behavioral services through their provider.
      Standard autism evaluation methods, weekly diet and sleep diaries and scheduled laboratory
      tests will be used to assess subjects. An end of study, follow-up assessment will be
      completed at 30 weeks after the start of the study.
    

Intervention name(s): Gluten- and casein-free diet; Placebo controlled diet
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Participants will follow a gluten-free and casein-free diet for 18 weeks. All children received individual EIBI interventions to decrease the confound of different types of therapies.; Participants will follow a gluten-free and casein-free diet for 18 weeks. They will receive double blind placebo controlled challenge snacks that contain gluten, casein, gluten+casein or placebo with measurement of response. They remain on the gluten free and casein free diet for the entire study period.
Intervention MeSH terms: Caseins
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Autism; Applied Behavioral Analysis; Gluten; Casein
Physiological Parameters and Crying Time in the Newborn Bath
Condition: Infant, Newborn
Study type: Interventional

Summary: 
      Bathing is essential for maintaining and improving the health of the newborn. It has numerous
      beneficial effects, such as cleaning and protecting the skin, preventing infections, cleaning
      unwanted substances, regulating blood circulation and the respiratory system, regulating body
      temperature, relieving pain, providing comfort, and supporting the parent-infant bond.
      Although bathing has many benefits, it is a stressful experience for newborn babies. Research
      on the effects of bathing on babies has shown that babies experience behavioral difficulties
      during bathing, such as crying, restlessness, hiccups, yawning, tremors, body looseness,
      looseness of the extremities, facial looseness, opening of fingers, and grimacing. Bathing
      may also lead to some physiological responses, such as hypothermia, hypoxia, dyspnea,
      cyanosis, desaturation, and tachycardia.Therefore, this study aimed to determine the effect
      of palmar grasp reflex stimulation during neonatal bath on the physiological parameters and
      crying time of the newborn.
    


Intervention name(s): Palmar Grasp Reflex Stimulation
Intervention type(s): Other
Intervention description(s): The palmar grasp reflex is an involuntary flexion-adduction movement involving the hands and fingers.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Supportive Care
An Analysis of the Effect of Topical Cromolyn Sodium on Rosacea-associated Erythema
Condition: Papulopustular Rosacea
MeSH terms: Rosacea; Erythema
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This study is designed to investigate whether topical application of a cromolyn sodium
      solution is able to decrease the facial redness seen in patients with papulopustular rosacea.
      Previous work in the lab of Dr. Di Nardo on mice has suggested that cromolyn may be able to
      have this effect. The study will enroll a total of 10 patients. 5 will randomly be assigned
      to receive the cromolyn sodium solution, and the other 5 will be randomly assigned to receive
      the placebo solution. All participants will be instructed to apply their assigned solution
      twice daily to their face. Patients will return to the clinic 3, 6, and 8 weeks after the
      distribution of the solutions to measure the efficacy of their assigned solution.
    


Intervention name(s): Cromolyn Sodium; Normal Saline
Intervention type(s): Drug; Drug
Other intervention name(s): Crolom; 0.9% sodium chloride; NaCl
Intervention MeSH terms: Cromolyn Sodium
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Rosacea; Cromolyn sodium
Reconstruction Plate Compared With Flexible Intramedullary Nailing for Midshaft Clavicular Fractures
Condition: Clavicle Fracture
MeSH terms: Fractures, Bone
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to compare the clinical and radiographic results of patients
      with midshaft clavicular fractures treated with plates or intramedullary flexible nails
      fixation.
    

Detailed description: 
      Midshaft clavicular fractures are classically treated with non-surgical methods, supported by
      many authors as an effective treatment. However, different researches have shown high rates
      of nonunion and clavicle malunion related to the nonoperative treatment. Currently,
      indications for surgical treatment are wider and include mainly the following: shortening
      greater than or equal to 2.0 cm, multiple trauma, open fractures or with imminent exposure
      and associated neurovascular injury.

      Plate fixation of midshaft clavicular fractures is widely described in the literature, and is
      considered the gold standard by different authors, associated with a high union rate and a
      low complication rate. Different types of plates have been used, including reconstruction
      plates, dynamic compression plates (DCP), low-contact dynamic compression plates (LC-DCP),
      semi-tubular plates, and pre-molded locking plates. Possible complications are postoperative
      infection, hardware loosening or failure, peri-incision paresthesia, neurovascular iatrogenic
      lesions, nonunion, and hardware related symptoms.

      Elastic stable intramedullary nailing (ESIN) technique has been used in recent years in the
      treatment of midshaft clavicular fractures. Different studies report excellent functional
      results and low complication rates. Some theoretical advantages in relation to plates are the
      3-point flexible nail support, which provides superior biomechanics resistance and uses the
      relative stability principle, favoring callus formation. When compared to plain steel wires,
      titanium nails have lower migration risk, due to its greater flexibility and better bone
      fixation.

      The purpose of this study is to compare the clinical and radiographic results of patients
      with midshaft clavicular fractures treated with reconstruction plates or ESIN.
    

Intervention name(s): Plate fixation; ESIN
Intervention type(s): Procedure; Procedure
Intervention description(s): Reconstruction plate; ESIN (Elastic Stable Intramedullary Nailing)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: clavicle; clavicular; fracture; midshaft; plate; ESIN; intramedullary; flexible; nailing
A Study to Assess the Levels of CAZ-AVI and Metronidazole in the Blood When Given Together and Separately
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of the study is to assess whether there is any pharmacokinetic interactions
      between CAZ-AVI and metronidazole.
    

Detailed description: 
      A Phase I, Open-Label, 3-way Crossover, Pharmacokinetic and Drug-Drug Interaction Study of
      ceftazidime avibactam (CAZ-AVI) and Metronidazole when Administered Alone and in Combination
      in Healthy Subjects
    

Intervention name(s): CAZ-AVI; metronidazole; CAZ-AVI + metronidazole
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Infusion; Infusion; Infusion
Intervention MeSH terms: Metronidazole
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Phase I; drug to drug; CAZ-AVI; Healthy volunteer; pharmacokinetics; open label; metronidazole; safety
Safety and Efficacy of Propranolol Eye Drops in Treating Retinopathy of Premature
Condition: Retinopathy of Prematurity
MeSH terms: Retinal Diseases; Retinopathy of Prematurity; Premature Birth
Study type: Interventional
Phase: Phase 2

Summary: 
      The aim of the present study is to evaluate the safety and efficacy of propranolol eye drops
      in preterm newborns with a precocious stage of retinopathy of prematurity (ROP). Preterm
      newborns (gestational age 23-32 weeks) with a stage 2 ROP (zone II without plus) will receive
      propranolol eye drops treatment until retinal vascularization will be completed.

      Propranolol concentrations will be measured on dried blood spots during the first 3 days of
      treatment and at the steady state. Cardiovascular and respiratory parameters will be
      continuously monitored. Blood samplings checking metabolic, renal and liver functions will be
      performed periodically, as well as cardiac function, in order to verify the treatment safety.
      Serial ophthalmological evaluations will be planned to monitor the efficacy of the treatment,
      the ROP progression and the possible complications.
    


Intervention name(s): Propranolol eye drops
Intervention type(s): Drug
Intervention description(s): All the enrolled preterm newborns will receive propranolol as ophthalmic solution (0,1%): 3 microdrops of 6 microliters (μL) propranolol solution (= 6 μg propranolol/microdrop) will be topically applied with a calibrated pipette, in each eye, three times daily (every 8 hours).The treatment will continue until the complete development of retinal vascularisation, but no more than 60 days.
The propranolol treatment will be always associated to the conventional approach adopted by the ETROP Cooperative Group.
Intervention MeSH terms: Propranolol; Ophthalmic Solutions
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Retinopathy of prematurity; Propranolol; Eye drops; Newborns; Retinal angiogenesis; Retinal neovascularization
A Study To Monitor Long-Term Treatment With PF-00547659
Condition: Crohn's Disease
MeSH terms: Crohn Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      This study provides open-label drug to eligible patients who have completed a prior study of
      PF-00547659. The primary endpoint for this study is long-term safety.
    

Detailed description: 
      The rationale for conducting this open-label extension (OLE) study is primarily to evaluate
      long term safety of PF 00547659. This protocol also provides the opportunity for continued
      treatment for subjects responding to treatment from the feeder study. It also provides an
      opportunity for initial treatment for subjects randomized to placebo in the feeder study.
      This is a multi center Phase 2, open label, safety extension study for feeder studies which
      evaluate PF 00546759 in subjects with moderate to severe Crohn's disease. Subjects eligible
      for this study will have completed the 12 week double blind induction period in study
      A7281006 and will be stratified by responders or non responders based on change in CDAI in
      that study, without unblinding treatment assignment from study A7281006. Additionally,
      subjects who have completed study A7281008 with a clinical response, as defined by that
      protocol, will also be eligible for this study and treated as "responders". All subjects
      entering this study must have discontinued immunosuppressant therapy.

      Subjects entering this study will be given a 75 mg SC dose at baseline and then every 4 weeks
      through Week 72. After the active treatment period, the subjects will enter a 24 month follow
      up period including 6 monthly visits followed by 18 month extended contact (every 6 month
      telephone contacts). At Week 96, subjects will undergo an End of Study visit but will
      continue the every 6 month telephone contacts until Week 168.
    

Intervention name(s): PF-00547659
Intervention type(s): Drug
Intervention description(s): 75 mg SC once monthly for 72 weeks. Subjects may escalate to 225 mg or de-escalate to 22.5 mg one time.
Intervention model: Single Group Assignment
Primary purpose: Treatment
Keywords: Active Crohn's disease; Anti-TNF Refractory; Immunosuppressant Refractory
Flurbiprofen Tablet vs Spray In Oral Soft Tissue Wounds
Condition: Oral Soft Tissue Conditions; Drug Effect; Drug Use
Study type: Interventional
Phase: Phase 4

Summary: 
      The amount of active ingredient in tablet form of flurbiprofen is higher than that in the
      oral spray form. Therefore, based on the hypothesis that the side effects that may occur
      depending on the dose can be reduced, this clinical study investigated whether tablet and
      spray form flurbiprofen would have similar effects on postoperative pain in primarily closed
      soft tissue wounds in the oral region.
    

Detailed description: 
      In line with the number of patients obtained after sample size calculation, the study was
      completed on 40 patients who met the inclusion criteria. Patients were healthy, volunteer
      individuals who required excision of the epulis fissuratum or frenulum with the indication of
      preprosthetic surgery. 2 groups were formed by simple randomization with 20 patients in the
      tablet group and 20 patients in the spray group. After the surgical procedure, tablet and
      spray flurbiprofen were prescribed according to the groups. Apart from these, paracetamol,
      chlorhexidine gluconate + benzidamine hydrochloride mouthwash were prescribed to all patients
      as rescue analgesics. The tissue fragments removed from the patients who underwent epulis
      excision were sent for histopathologic evaluation and confirmed.
    

Intervention name(s): Flurbiprofen
Intervention type(s): Drug
Intervention description(s): The efficacy of two different forms and amounts of active ingredient (100mg tablet vs 25% oral spray) on postoperative pain of different flurbiprofen
Other intervention name(s): Spray flurbiprofen vs Tablet flurbiprofen
Intervention MeSH terms: Flurbiprofen
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: flurpibrofen; oral soft tissue