TrialPanorama/TrialPanorama-database huggingface dataset:
Study: NCT03610646

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: MYL-1701P
Description: Subjects will receive intravitreal injections of MYL-1701P throughout the 52-week treatment period, with the last dose at 48 weeks.~The additional doses may be administered in accordance with the protocol.

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Eylea
Description: Subjects will receive intravitreal injections of Eylea throughout the 52-week treatment period, with the last dose at 48 weeks.~The additional doses may be administered in accordance with the protocol.
Study: NCT01200316

Intervention type: PROCEDURE
Group type: EXPERIMENTAL
Intervention: Standard of Care
Description: Post surgical patient to sit in a non-rocking chair for at least sixty minutes per day, and ambulating at least three times per day.

Intervention type: PROCEDURE
Group type: EXPERIMENTAL
Intervention: Rocking Chair Motion
Description: Post surgical patient to rock in a rocking chair in 10-20 minute increments for at least sixty minutes per day, and ambulating at least three times per day.

Intervention type: BEHAVIORAL
Group type: EXPERIMENTAL
Intervention: Questionnaire
Description: Beginning on day of surgery till discharge (3-5 days)

Intervention type: BEHAVIORAL
Group type: EXPERIMENTAL
Intervention: Questionnaire
Description: Beginning on day of surgery till discharge (3-5 days)
Study: NCT03196739

Intervention type: DEVICE
Group type: EXPERIMENTAL
Intervention: Virtual rehabilitation
Description: A total of 10 sessions were held for 30 minutes, 2 to 3 times a week for upper limb rehabilitation using immersive virtual reality under the assistance of an occupational therapist.
Study: NCT00467038

Intervention type: BEHAVIORAL
Group type: OTHER
Intervention: Dialectical Behavior
Description: Dialectical Behavior Therapy is an empirically validated treatment approach emphasizing the role of emotion regulation in the treatment of suicidal and self-destructive behaviors in BPD
Study: NCT01087801

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: ChiRhoStim
Description: Human Secretin for Injection

Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Placebo
Description: Saline for Injection
Study: NCT02223598

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: CB-5083

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: CB-5083

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: CB-5083

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Dexamethasone
Study: NCT01502917

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Radioactive iodine-labeled monoclonal antibody omburtamab
Description: Prior to treatment children will be pre-medicated with super-saturated potassium iodide \& liothyronine to prevent thyroid uptake of the therapeutic radioisotopes. The proposed intervention is a surgical procedure using interstitial infusion of the radiolabeled monoclonal antibody 124I-omburtamab into the brain stem tumor. This will be performed by stereotactic placement of a small caliber infusion cannula into the tumor followed by a slow infusion (CED) of 124I-omburtamab. Following treatment, these children will be monitored during inpatient hospitalization with clinical evaluations \& PET/CT or PET/MRI scans of the brain \& other organs. Clinical observations, intensive care unit monitoring, routine blood \& interval imaging studies (MRI \& PET/CT or PET/MRI scans) will be performed at predetermined time points. If the PET/CT scan happens to fall on a weekend or holiday, the scan may be done before or after at the discretion of the Study PI. This will not affect dosimetry interpretation.

Intervention type: RADIATION
Group type: EXPERIMENTAL
Intervention: External Beam Radiotherapy
Description: Standard radiation therapy is given 4-6 weeks prior to study entry.
Study: NCT01687400

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: decitabine
Study: NCT02149199

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: budesonide/formoterol 'as needed' + budesonide placebo bid
Description: Symbicort (budesonide/ formoterol) 160/4.5 μg powder for inhalation 'as needed' plus Pulmicort placebo 200 μg powder for inhalation, 1 inhalation twice daily (morning and evening), 52-week treatment

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: terbutaline 'as needed' + placebo budesonide bid
Description: Terbutaline 0.4 mg powder for inhalation 'as needed' plus placebo Pulmicort (budesonide) 200 μg powder for inhalation, 1 inhalation twice daily (morning and evening), 52-week treatment

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: budesonide bid + terbutaline 'as needed'
Description: Pulmicort (budesonide) 200 μg powder for inhalation, 1 inhalation twice daily (morning and evening) plus terbutaline 0.4 mg powder for inhalation 'as needed', 52-week treatment
Study: NCT02473627

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: DS-1971a
Description: 200mg tablet

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: midazolam hydrochloride
Description: 2.5mg oromucosal liquid

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: midazolam hydrochloride
Description: 2.5mg oromucosal liquid
Study: NCT03614065

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: endostar
Description: endostatin
Study: NCT02473627

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Omeprazole
Description: 20mg gastro-resistant capsule
Study: NCT01831089

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: PM01183 + paclitaxel +/- bevacizumab
Description: PM01183: 1 mg and 4 mg vials. Powder for concentrate for solution for infusion~paclitaxel: 6 mg/ml concentrate for solution for infusion~bevacizumab: 25 mg/ml concentrate for solution for infusion~Once a recommended dose is defined for the PM01183 and weekly paclitaxel combination, the feasibility of adding bevacizumab to this combination will be explored in a prospectively selected cohort of patients
Study: NCT00452634

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Irinotecan
Description: Irinotecan 65mg/m2/iv over 90min on day 1 and 8, repeat Q 3weeks. until disease progression, unacceptable toxicity or patients' refusal.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Cisplatin
Description: Cisplatin 30mg/m2/iv over 30min on day 1 and 8, repeat Q 3weeks. until disease progression, unacceptable toxicity or patients' refusal.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Simvastatin
Description: simvastatin 40mg/QD, PO, daily, every 3 weeks
Study: NCT03494257

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Brinzolamide-Brimonidine fixed combination
Description: Simbrinza 0.2%-1% Ophthalmic Suspension
Study: NCT02340039

Intervention type: DIETARY_SUPPLEMENT
Group type: EXPERIMENTAL
Intervention: Polyphenols
Description: Drinks will be delivered in random order at 3 separate study visits immediately before a high-carbohydrate meal. Seven days wash-out period will be required between study days.

Intervention type: DIETARY_SUPPLEMENT
Group type: EXPERIMENTAL
Intervention: Polyphenols
Description: Drinks will be delivered in random order at 3 separate study visits immediately before a high-carbohydrate meal. Seven days wash-out period will be required between study days.

Intervention type: DIETARY_SUPPLEMENT
Group type: PLACEBO_COMPARATOR
Intervention: Polyphenols
Description: Drinks will be delivered in random order at 3 separate study visits immediately before a high-carbohydrate meal. Seven days wash-out period will be required between study days.
Study: NCT00816634

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Capecitabine plus cisplatin(XP) versus capecitabine plus paclitaxel(XT)
Description: 3.2 Overview of Study Design This study is a prospective, randomized, phase II study comparing response rate between patients with XP chemotherapy versus XG chemotherapy for patients with metastatic squamous cell carcinoma.~Chemotherapy regimen (XP):~D1- D14 Capecitabine 1000 mg/m2 bid p.o. D1 Cisplatin 75 mg/m2 + NS 150mL MIV over 1hr every 3 weeks~Chemotherapy regimen (XT):~D1- D14 Capecitabine 1000 mg/m2 bid p.o. D1, D8 Genexol (Paclitaxel) 80 mg/m2 + D5W 500mL MIV over 3hrs every 3 weeks

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Capecitabine plus cisplatin(XP) versus capecitabine plus paclitaxel(XT)
Description: 3.2 Overview of Study Design This study is a prospective, randomized, phase II study comparing response rate between patients with XP chemotherapy versus XG chemotherapy for patients with metastatic squamous cell carcinoma.~Chemotherapy regimen (XP):~D1- D14 Capecitabine 1000 mg/m2 bid p.o. D1 Cisplatin 75 mg/m2 + NS 150mL MIV over 1hr every 3 weeks~Chemotherapy regimen (XT):~D1- D14 Capecitabine 1000 mg/m2 bid p.o. D1, D8 Genexol (Paclitaxel) 80 mg/m2 + D5W 500mL MIV over 3hrs every 3 weeks
Study: NCT00215852

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Alferon LDO
Description: 500 IU, taken orally each evening, for 10 consecutive days while holding in the mouth for at least 2 minutes prior to swallowing, for 10 daysday 5 of each 28 day cycle.

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Alferon LDO
Description: 500 IU, taken orally each evening, for 10 consecutive days while holding in the mouth for at least 2 minutes prior to swallowing, for 10 daysday 5 of each 28 day cycle.

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Alferon LDO
Description: 500 IU, taken orally each evening, for 10 consecutive days while holding in the mouth for at least 2 minutes prior to swallowing, for 10 daysday 5 of each 28 day cycle.
Study: NCT03614065

Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Placebos
Description: saline solution

Intervention type: RADIATION
Group type: PLACEBO_COMPARATOR
Intervention: radiotherapy
Description: radiotherapy
Study: NCT01053923

Intervention type: OTHER
Intervention: Magnetic Resonance Imaging (MRI)
Description: This study involves three imaging sessions (Magnetic Nuclear Resonance -MRI), with one session before radiation therapy and two sessions during radiation therapy (one at 3 weeks of RT; the other during the last week of RT). Each imaging session will last for approximately 45 to 60 minutes.
Study: NCT03430154

Intervention type: OTHER
Intervention: No treatment given
Description: No treatment given

Intervention type: OTHER
Intervention: No treatment given
Description: No treatment given

Intervention type: OTHER
Intervention: No treatment given
Description: No treatment given

Intervention type: OTHER
Intervention: No treatment given
Description: No treatment given
Study: NCT00363714

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: AGN211745
Description: 100microgram single intravitreal injection

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: AGN211745
Description: 200microgram single intravitreal injection

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: AGN211745
Description: 400microgram single intravitreal injection

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: AGN211745
Description: 800microgram single intravitreal injection

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: AGN211745
Description: 1200microgram single intravitreal injection

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: AGN211745
Description: 1600microgram single intravitreal injection
Study: NCT03614065

Intervention type: RADIATION
Group type: EXPERIMENTAL
Intervention: radiotherapy
Description: radiotherapy
Study: NCT02339428

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: diclophenac sodium
Description: Patients will be given 100mg p.o. diclophenac sodium tablets

Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Placebo
Description: Inactive pill manufactured to mimic diclofenac tablet
Study: NCT03963895

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: AB002 Dose 1
Description: AB002 (E-WE thrombin) 1.5 mcg/kg administered on Day 1 as a single intravenous infusion

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: AB002 Dose 2
Description: AB002 (E-WE thrombin) 3.0 mcg/kg administered on Day 1 as a single intravenous infusion

Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: placebo
Description: placebo administered on Day 1 as a single intravenous infusion
Study: NCT02169934

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Radiolabeled TRV130
Description: A single 2 mg IV dose administered as a 10 mL manual IV push over 2 minutes
Study: NCT00871481

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: ipilimumab
Description: Given IV

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: cyclophosphamide
Description: Given IV

Intervention type: PROCEDURE
Group type: EXPERIMENTAL
Intervention: biopsy
Description: Optional correlative studies

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: aldesleukin
Description: Given SC

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: immunohistochemistry staining method
Description: Correlative studies

Intervention type: GENETIC
Group type: EXPERIMENTAL
Intervention: polymerase chain reaction
Description: Correlative studies

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: immunoenzyme technique
Description: Correlative studies
Study: NCT02011516

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Baclofen

Intervention type: BEHAVIORAL
Group type: ACTIVE_COMPARATOR
Intervention: Psychosocial

Intervention type: BEHAVIORAL
Group type: PLACEBO_COMPARATOR
Intervention: Psychosocial

Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Placebo
Study: NCT02665026

Intervention type: PROCEDURE
Group type: EXPERIMENTAL
Intervention: stoma closure at different times
Description: Early closure: stoma closure in 12 weeks after surgery for rectal cancer; Late group: stoma closure in 24 weeks after surgery for rectal cancer
Study: NCT02473627

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Omeprazole
Description: 20mg gastro-resistant capsule

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Pioglitazone hydrochloride
Description: 15mg tablet

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Pioglitazone hydrochloride
Description: 15mg tablet
Study: NCT04656574

Intervention type: BEHAVIORAL
Group type: EXPERIMENTAL
Intervention: Simulation-based training
Description: The simulation training included the activities that midwives should do during the birth and management of vaginal delivery with episiotomy. The students received theoretical training, and to reinforce it, they were asked to mold a fetal head from a potato, make a cardboard cervix showing dilatation measurements during vaginal delivery, and make a fetal position identification model taking the occiput as a reference point.
Study: NCT02473627

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Buproprion
Description: 150mg Prolonged release tablet

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Buproprion
Description: 150mg Prolonged release tablet
Study: NCT02214004

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Trastuzumab
Description: - Eight times IV administration of trastuzumab per 3 weeks~* Trastuzumab 8mg/kg on Day 1 of Cycle 1~* Trastuzumab 6mg/kg from Day 1 of Cycle 2 to Day 1 of Cycle 8

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Letrozole
Description: - Daily letrozole 2.5 mg/day for 24 weeks
Study: NCT02797626

Intervention type: PROCEDURE
Group type: OTHER
Intervention: Primary retroperitoneal lymph-node dissection (pRPLND)
Description: Open or laparoscopic robotic-assisted nerve-sparing retroperitoneal lymph node dissection (modified template RPLND, if possible ipsilateral nerve-sparing)
Study: NCT02473627

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Tolbutamide
Description: 500mg tablet

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Tolbutamide
Description: 500mg tablet
Study: NCT01930162

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: HSC835
Description: HSC835 is a stem cell therapy product providing a source of Hematopoietic stem cell (HSC).
Study: NCT00520377

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: MD05
Description: recombinant human GDF-5 coated onto beta-tricalcium phosphate

Intervention type: DEVICE
Group type: ACTIVE_COMPARATOR
Intervention: Beta-TCP and autologous bone
Description: beta-tricalcium phosphate and autologous bone
Study: NCT06069219

Intervention type: DRUG
Intervention: Epidural administration of sufentanil
Description: The epidural cannulations were placed by anesthesiologists before general anesthesia. Correct positioning of the catheters were tested and confirmed by negative aspiration and injection of 3 mL of 2% Lidocaine. The epidural infusion (solution of 0.2 % ropivacaine 5 ml with 25 to 50 mcg sufentanil in 50 ml of 0,9% NaCl) was started with bolus of 5 ml over 5 minutes and then continuous infusion was maintained was throughout the surgery at 3-12 mL/h and 2-12 mL/h after the surgery. Single dose of sufentanil was given when needed.
Study: NCT04681495

Intervention type: BEHAVIORAL
Group type: OTHER
Intervention: STAC
Description: STAC is a brief, stand-alone bullying bystander intervention for middle school students, to reduce bullying and mental health risks for bystanders. The primary outcome will be showing usability for the technology-based program (STAC-T) prototype.
Study: NCT03413982

Intervention type: OTHER
Intervention: Registry
Description: Patient registry
Study: NCT03891875

Intervention type: COMBINATION_PRODUCT
Group type: EXPERIMENTAL
Intervention: Subcutaneous elamipretide through the elamipretide delivery system
Description: Subjects will be randomized in a 2:1 ratio to receive either elamipretide or placebo through the elamipretide delivery system. Subjects will dose daily for up to 48 weeks.

Intervention type: COMBINATION_PRODUCT
Group type: PLACEBO_COMPARATOR
Intervention: Subcutaneos placebo through the elamipretide delivery system
Description: Subjects will be randomized in a 2:1 ratio to receive either elamipretide or placebo through the elamipretide delivery system. Subjects will dose daily for up to 48 weeks.
Study: NCT02276248

Intervention type: RADIATION
Group type: EXPERIMENTAL
Intervention: Intensity-modulated radiation therapy
Description: total dose: 50 to 56 grays per fraction: 2 grays

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: GDP chemotherapy
Description: gemcitabine (1000mg/m2 intravenously over 30 minutes on days 1 and 8), cisplatin (25mg/m2 intravenously over 60 minutes on days 1-3), and dexamethasone (20mg/d orally on days 1-4 and days 11-14), which was administered every 21 days.
Study: NCT04580173

Intervention type: DIAGNOSTIC_TEST
Intervention: metabolomics analysis
Description: Targeted and untargeted metabolomics-based analysis will be performed using Gas Chromatography tandem Mass Spectometry and Liquid Chromatography tandem Mass Spectrometry, in order to quantify serum biomarkers.

Intervention type: DIAGNOSTIC_TEST
Intervention: metabolomics analysis
Description: Targeted and untargeted metabolomics-based analysis will be performed using Gas Chromatography tandem Mass Spectometry and Liquid Chromatography tandem Mass Spectrometry, in order to quantify serum biomarkers.

Intervention type: DIAGNOSTIC_TEST
Intervention: metabolomics analysis
Description: Targeted and untargeted metabolomics-based analysis will be performed using Gas Chromatography tandem Mass Spectometry and Liquid Chromatography tandem Mass Spectrometry, in order to quantify serum biomarkers.

Intervention type: DIAGNOSTIC_TEST
Intervention: metabolomics analysis
Description: Targeted and untargeted metabolomics-based analysis will be performed using Gas Chromatography tandem Mass Spectometry and Liquid Chromatography tandem Mass Spectrometry, in order to quantify serum biomarkers.
Study: NCT02308930

Intervention type: DIETARY_SUPPLEMENT
Group type: EXPERIMENTAL
Intervention: Vitamins + DHA supplement (Vitamins A,D, E and algal oil)

Intervention type: DIETARY_SUPPLEMENT
Group type: OTHER
Intervention: Vitamins supplement (Vitamins A,D, E and corn oil)
Study: NCT04774809

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Low Dose SHR0302 Ointment BID
Description: Low Dose SHR0302 Ointment BID

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: High Dose SHR0302 Ointment BID
Description: High Dose SHR0302 Ointment BID

Intervention type: OTHER
Group type: PLACEBO_COMPARATOR
Intervention: Placebo Comparator: Vehicle
Description: Placebo
Study: NCT01542242

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Liraglutide
Description: Liraglutide 0.6 mg SQ daily for one week, increase to a maximum dose of 1.8 mg SQ daily by 6 weeks, and subsequent continuation for the remainder of a year.
Study: NCT01047566

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Dronedarone
Description: Pharmaceutical form: tablet Route of administration: oral Dose regimen: 400 mg twice daily for 12 weeks (+/- 5 days)

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Beta blocker or calcium antagonist or digoxin
Description: Dose increase of beta blocker or calcium antagonist or digoxin
Study: NCT00871481

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: therapeutic cytotoxic T lymphocytes
Description: Given IV
Study: NCT02117570

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: Clostridium difficile vaccine
Description: 0.5 mL intramuscular injection on day 1, day 8, and day 30.
Study: NCT01554527

Intervention type: PROCEDURE
Group type: EXPERIMENTAL
Intervention: CPAP treatment
Description: 6 months of treatment with PAP (CPAP or BPAP)

Intervention type: OTHER
Group type: OTHER
Intervention: No CPAP treatment
Description: Children randomized to the comparison group will receive routine care
Study: NCT00782626

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: everolimus
Study: NCT01755780

Intervention type: OTHER
Intervention: Left interscalene block

Intervention type: OTHER
Intervention: Right interscalene block
Study: NCT01870752

Intervention type: PROCEDURE
Group type: OTHER
Intervention: Transplantation of previously cryopreserved ovarian tissu
Study: NCT02238886

Intervention type: DIETARY_SUPPLEMENT
Group type: EXPERIMENTAL
Intervention: Parenteral nutrition. SMOFKABIVEN infusion in central vene. Fresenius Kabi
Study: NCT02604186

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: Botulinum Toxin Injections
Description: Each patient in the treatment group will receive 400 units of botulinum toxin. 100 units will be injected at adductors at each leg and 100 units will be applied in each triceps surae bilaterally.

Intervention type: OTHER
Group type: PLACEBO_COMPARATOR
Intervention: Placebo Injections
Description: Each patient in the placebo group will receive sterile sodium chloride injections at adductors and triceps surae muscles bilaterally.
Study: NCT00803673

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: 100mcg
Description: 100mcg '719

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: 500mcg
Description: 500mcg '719

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: 1000mcg
Description: 1000mcg '719

Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Placebo
Description: Placebo '719
Study: NCT01519895

Intervention type: BEHAVIORAL
Group type: EXPERIMENTAL
Intervention: Telephone intervention
Description: counseling and education support