AIM-Harvard/TrialPanorama-filtered huggingface dataset:
Study NCT04451954 — intervention group
Intervention type: BIOLOGICAL
Group type: ACTIVE_COMPARATOR
Intervention: Quadrivalent RIV with 2018-2019 NH H3 strain
Description: Pharmaceutical form: Suspension for injection Route of administration: Intramuscular
Study NCT04451954 — intervention group
Intervention type: BIOLOGICAL
Group type: ACTIVE_COMPARATOR
Intervention: Quadrivalent RIV with 2018-2019 NH H3 strain and adjuvant
Description: Pharmaceutical form: Suspension for injection Route of administration: Intramuscular
Study NCT03529773 — intervention group
Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: Formulation A
Description: RSV vaccine
Study NCT03529773 — intervention group
Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: Formulation B
Description: RSV vaccine
Study NCT03529773 — intervention group
Intervention type: BIOLOGICAL
Group type: PLACEBO_COMPARATOR
Intervention: Placebo
Description: Placebo
Study NCT01558362 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: 123I-CMICE-013
Description: 2 intravenous doses of drug will be given one week apart. Doses will be equivalent to 1 rest dose and 1 stress dose. Serial nuclear imaging will follow dose injections.
Study NCT01496066 — intervention group
Intervention type: DEVICE
Group type: EXPERIMENTAL
Intervention: LAL (Light Adjustable Lens) and Light Deliver Device (LDD)
Description: LAL implanted and adjusted with LDD
Study NCT01496066 — intervention group
Intervention type: DEVICE
Group type: ACTIVE_COMPARATOR
Intervention: Monofocal control IOL
Description: Commercially available monofocal intraocular lens (IOL)
Study NCT02117765 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Ustekinumab
Study NCT03662425 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Oxytocin
Description: It's a two-week treatment trial.Subjects self-administer intranasal study drug twice daily; before breakfast and before dinner. Each dose consists of six 0.1 ml insufflations (alternating between the left and right nostril) of OT spray containing approximately 24 international units of OT
Study NCT03662425 — intervention group
Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Saline
Description: It's a two-week treatment trial. Subjects self-administer intranasal study drug twice daily; before breakfast and before dinner. Each dose consists of six 0.1 ml insufflations (alternating between the left and right nostril) of saline spray containing approximately 24 international units of saline
Study NCT03237065 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Iron isomaltoside/ferric derisomaltose
Description: Iron isomaltoside/ferric derisomaltose (Monofer®/Monoferric®; 100 mg/mL) was the test product in this trial.~The dose of iron isomaltoside/ferric derisomaltose for the individual subject was a single IV infusion of 1000 mg (10 mL containing 1000 mg iron isomaltoside/ferric derisomaltose diluted in 100 mL 0.9 % sodium chloride), given over approximately 20 minutes (50 mg iron/min) at baseline (cumulative dose: 1000 mg).
Study NCT03237065 — intervention group
Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Ferric carboxymaltose
Description: Ferric carboxymaltose (Injectafer®; 50 mg/mL) was the comparator in this trial. The dose of ferric carboxymaltose for the individual subject was 750 mg, infused over at least 15 minutes at baseline and on day 7 (cumulative dose: 1500 mg).
Study NCT00793650 — intervention group
Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Bortezomib
Description: Escalating doses of bortezomib 1.0, 1.3, or 1.6 mg/m2 in Arm A and Arm B.
Study NCT00793650 — intervention group
Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Melphalan
Description: All patients received melphalan (100 mg/m\^2/day × 2; days~-3 and -2), for a total dose of 200 mg/m\^2.
Study NCT00793650 — intervention group
Intervention type: PROCEDURE
Group type: ACTIVE_COMPARATOR
Intervention: Autologous PBSC Transplant
Description: Day 0 consists of the stem cell infusion.
Study NCT04032990 — intervention group
Intervention type: DEVICE
Group type: EXPERIMENTAL
Intervention: Biostim-5 transcutaneous spinal stimulator
Description: Safety and feasibility will be monitored during transcutaneous spinal stimulation in children with spinal cord injury
Study NCT03589378 — intervention group
Intervention type: PROCEDURE
Group type: EXPERIMENTAL
Intervention: PEAF
Description: PEAF that is therapeutic plasma exchange (TPE) with 20ml/kg/d Fresh frozen plasma (Blood pump: 120ml/min, replacement pump 20ml/kg/min, dialysate pump 0ml/kg/min, waste pump 20ml/kg/min, plasma exchange 1 hour) plus plasma filtration adsorption (PFA ) with acute multitherapeutic system( AMPLYA™ ITALY) ≥30ml/min lasting 15 hours plus High volume plasma diafiltration (HVPDF) with CUREFLO™(ACF180W Japan) or Ultraflux® (AV1000S Fresenius Germany) Blood pump: 120ml/min, replacement fluid pump 2000ml/h, dialysate pump 2000ml/h, waste pump 4000ml/h,and with high-volume plasma diafiltration for 15 hours）in the first 3 days. the treatment after three days later is same as the control group.
Study NCT03524339 — intervention group
Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Placebo oral capsule
Description: Tamsulosin or placebo will be given for 3 days prior to surgery and one week after surgery to determine its effects on postoperative urinary retention.
Study NCT03524339 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Tamsulosin
Description: Tamsulosin or placebo will be given for 3 days prior to surgery and one week after surgery to determine its effects on postoperative urinary retention.
Study NCT00772668 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Rituximab
Description: Administered intravenously during induction and maintenance therapy per protocol.
Study NCT00772668 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Bortezomib
Description: Administered intravenously per protocol.
Study NCT00772668 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Cyclophosphamide
Description: Administered intravenously per protocol.
Study NCT00772668 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Prednisone
Description: Administered orally (PO) per protocol.
Study NCT00864955 — intervention group
Intervention type: RADIATION
Group type: EXPERIMENTAL
Intervention: UVA and UVB irradiation
Description: * 4 cutaneous biopsies for Ex-vivo irradiation~* Determination of the minimal erythemic dose of UVA and UVB for each volunteer
Study NCT01331356 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Botox
Description: One injection of botulinum toxin type A in the ganglion Impar in patients with chronic proctalgia
Study NCT04114435 — intervention group
Intervention type: OTHER
Intervention: Echocardiography
Description: Diagnostic test which uses ultrasound waves to make images of the heart chambers, valves and surrounding structures
Study NCT04146610 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: an antibody drug conjugate
Description: Multiple dose grouping
Study NCT03703973 — intervention group
Intervention type: DIAGNOSTIC_TEST
Intervention: Neuropsychology test
Description: We do the neuropsychological tests, Mini-Mental score examination (MMSE) and olfaction test 1 day before (baseline) and 1 week,3 months,1 year and 3 years after surgery without safety issue.
Study NCT03324997 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Restylane Silk
Description: Restylane Silk is a temporary hyaluronic acid filler currently approved for the lips and fine lines around the mouth.
Study NCT03324997 — intervention group
Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Saline
Description: Saline as placebo
Study NCT03324997 — intervention group
Intervention type: DEVICE
Group type: PLACEBO_COMPARATOR
Intervention: Optical Coherence Tomography
Description: An FDA-cleared non-invasive imaging device
Study NCT03324997 — intervention group
Intervention type: DEVICE
Group type: EXPERIMENTAL
Intervention: Optical Coherence Tomography
Description: An FDA-cleared non-invasive imaging device
Study NCT04492683 — intervention group
Intervention type: COMBINATION_PRODUCT
Group type: EXPERIMENTAL
Intervention: DBV1605
Description: Ready-to-use atopy patch test for diagnostic use containing 2 distinct patches:~* One active patch containing a dry deposit of 180 μg of cow's milk proteins~* One control patch with the same design as the active patch but devoid of any formulation.
Study NCT03504410 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: CPI-613 + High Dose Cytarabine and Mitoxantrone
Description: CPI-613 + High Dose Cytarabine and Mitoxantrone CPI-613: 2000mg/m2, 5 doses once a day, days 1-5 Cytarabine 1gm/m2, 5 doses every 12hrs starting day 3 through day 5 Mitoxantrone 6mg/m2, 3 doses, once a day following the first, third and fifth doses of Cytarabine
Study NCT03504410 — intervention group
Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: High Dose Cytarabine and Mitoxantrone
Description: Cytarabine 1gm/m2, 5 doses every 12hrs starting day 3 through day 5 Mitoxantrone 6mg/m2, 3 doses, once a day following the first, third and fifth doses of Cytarabine
Study NCT03504410 — intervention group
Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Mitoxantrone, Etoposide and Cytarabine
Description: Mitoxantrone, Etoposide and Cytarabine~Etoposide 80mg/m over 60 minutes as a central line IV infusion; 6 doses Day 1 though 6 Cytarabine 1000mg/m2 over 3 hours as a central line IV infusion: 6 doses, Day 1 through 6 Mitoxantrone 6 mg/m2 over 30 minutes as a central line IV infusion: 6 dose, Day 1 through 6
Study NCT03504410 — intervention group
Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Fludarabine, Cytarabine, Filgrastim
Description: Fludarabine, Cytarabine and Filgrastim~Fludarabine 30mg/m2/day over 30 minutes as a central line IV infusion; 5 doses Day 1 though 5 Cytarabine 2g/m2 over 4 hours as a central line IV infusion: 4 hours after Fludarabine: 5 doses, Day 1 through 5 Filgrastim 5µg/kg/day by SQ or as per institutional guidelines starting from Day 1 through Day 5
Study NCT02321254 — intervention group
Intervention type: DEVICE
Group type: EXPERIMENTAL
Intervention: The RehaARM-Robot
Description: Robot therapy by using a 3-Degrees-Of-Freedom (3DOFs) robot to train the shoulder.
Study NCT02321254 — intervention group
Intervention type: BEHAVIORAL
Group type: EXPERIMENTAL
Intervention: Standard rehabilitation therapy
Description: Standard therapy of stroke rehabilitation including speech, physical, occupational therapies and group activities.
Study NCT03784066 — intervention group
Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Durvalumab
Description: All patients will be treated with postoperative radiotherapy (66 Gy in standard fractionation).~In case of positive section margins or extracapsular extension, 3 cycles of cisplatin 100 mg/msq on days 1, 22, and 43 will be added to standard fractionation radiotherapy (66 Gy).~Durvalumab monotherapy (1500 mg) will be administered via IV infusion day -14 and at the start of radiation therapy, with repeat administration every 4 weeks at fixed dose for a total of 6 cycles postoperative.
Study NCT03784066 — intervention group
Intervention type: COMBINATION_PRODUCT
Group type: ACTIVE_COMPARATOR
Intervention: Durvalumab + Tremelimumab
Description: All patients will be treated with postoperative radiotherapy (66 Gy in standard fractionation).~In case of positive section margins or extracapsular extension, 3 cycles of cisplatin 100 mg/msq on days 1, 22, and 43 will be added to standard fractionation radiotherapy (66 Gy).~Durvalumab + Tremelimumab combination therapy: Tremelimumab (75 mg) will be administered via IV infusion day -14 and at the start of radiation therapy, with repeat administration every 4 weeks at fixed dose for a total of 3 cycles postoperative, Durvalumab (1500 mg) will be administered via IV infusion day -14 and at the start of radiation therapy, with repeat administration every 4 weeks at fixed dose for a total of 6 cycles postoperative.
Study NCT03375450 — intervention group
Intervention type: OTHER
Intervention: Standard of Care
Description: Participants will be followed as per local routine primary healthcare practice
Study NCT01515787 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: FOLFOX (chemotherapy)
Description: Oxaliplatin 85 mg/m\^2 IV over 2 hours on day 1, leucovorin 400 mg/m\^2 bolus IV over 2 hours on day 1 and 5-fluorouracil 400 mg/m\^2 bolus over 5-15 minutes then 2400 mg/m\^2 continual over 46-48 hours total dose IV on days 1-2. The treatment schedule repeats based on the group. Dose modifications are allowed based on adverse events.
Study NCT01515787 — intervention group
Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: FOLFOX (chemotherapy)
Description: Oxaliplatin 85 mg/m\^2 IV over 2 hours on day 1, leucovorin 400 mg/m\^2 bolus IV over 2 hours on day 1 and 5-fluorouracil 400 mg/m\^2 bolus over 5-15 minutes then 2400 mg/m\^2 continual over 46-48 hours total dose IV on days 1-2. The treatment schedule repeats based on the group. Dose modifications are allowed based on adverse events.
Study NCT01515787 — intervention group
Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: 5 FUCMT (chemoradiation)
Description: 5-fluorouracil 225 mg/m\^2 per day continuous IV infusion administered concurrently with radiation therapy for 5 or 7 days per week OR capecitabine 825 mg/m\^2 twice daily administered orally and concurrently with radiation therapy for 5 days per week. Dose modifications are allowed based on adverse events.
Study NCT01515787 — intervention group
Intervention type: OTHER
Group type: ACTIVE_COMPARATOR
Intervention: 5 FUCMT (chemoradiation)
Description: 5-fluorouracil 225 mg/m\^2 per day continuous IV infusion administered concurrently with radiation therapy for 5 or 7 days per week OR capecitabine 825 mg/m\^2 twice daily administered orally and concurrently with radiation therapy for 5 days per week. Dose modifications are allowed based on adverse events.
Study NCT01515787 — intervention group
Intervention type: PROCEDURE
Group type: EXPERIMENTAL
Intervention: surgery
Description: low anterior resection with total mesorectal excision
Study NCT01515787 — intervention group
Intervention type: PROCEDURE
Group type: ACTIVE_COMPARATOR
Intervention: surgery
Description: low anterior resection with total mesorectal excision
Study NCT01515787 — intervention group
Intervention type: PROCEDURE
Group type: EXPERIMENTAL
Intervention: magnetic resonance imaging or endorectal ultrasound
Study NCT01857713 — intervention group
Intervention type: DEVICE
Group type: ACTIVE_COMPARATOR
Intervention: Reza Band UES Assist Device
Description: Device is worn by patient to reduce or eliminate laryngopharyngeal reflux
Study NCT03404011 — intervention group
Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: Propylene glycol and Glycerol intake
Description: Intake of 1 gram of propylene glycol/Glycerol mix (50:50). Blood sample before, 5 minutes and 20 minutes after intake.
Study NCT03404011 — intervention group
Intervention type: DEVICE
Group type: PLACEBO_COMPARATOR
Intervention: Mimicking intake
Description: Mimicking propylene glycol/glycerol intake with the device turns off. Blood sample before, 5 minutes and 20 minutes after intake.
Study NCT03665402 — intervention group
Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Isoniazid
Description: One of the first line anti-tubercolosis drug
Study NCT03665402 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Isoniazid
Description: One of the first line anti-tubercolosis drug
Study NCT03554915 — intervention group
Intervention type: OTHER
Intervention: Ketamine-based protocol
Description: For profoundly agitated (physically violent) patients, intramuscular ketamine 5 mg/kg will be administered first line. For severely agitated patients, intramuscular ketamine 3 mg/kg will be administered first line.
Study NCT03554915 — intervention group
Intervention type: OTHER
Intervention: Midazolam-based protocol
Description: For profoundly agitated patients, intramuscular midazolam 15 mg will be administered. For severely agitated patients, intramuscular midazolam 5 mg will be administered.
Study NCT02973737 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: pyrotinib
Description: 400 mg once daily
Study NCT02973737 — intervention group
Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: placebo
Description: 400 mg once daily
Study NCT02973737 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Capecitabine
Description: 1000 mg/m2 per day on day 1 through 14, every 21 days.
Study NCT02973737 — intervention group
Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Capecitabine
Description: 1000 mg/m2 per day on day 1 through 14, every 21 days.
Study NCT05930262 — intervention group
Intervention type: DEVICE
Group type: EXPERIMENTAL
Intervention: TCM acupuncture therapy
Description: TCM acupuncture therapy: Zusanli, Quchi, Hegu, Taichong, Feishu and Fenglong were selected as the main acupoints, and the auxiliary acupoints were selected according to the symptoms, including Fengchi, Dazhui, Lieque, Tiantu, Shenshu, Zhongfu, etc.
Study NCT05930262 — intervention group
Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Conventional drug therapy
Description: Antibiotics were selected based on drug sensitivity test results. Patients with body temperature > 38.5℃ were treated with physical cooling and antipyretic drugs. In patients whose sputum was thick and difficult to cough up, nebulization and inhalation therapy was given, as well as effective coughing and patting the back to expel phlegm were guided.
Study NCT05930262 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Conventional drug therapy
Description: Antibiotics were selected based on drug sensitivity test results. Patients with body temperature > 38.5℃ were treated with physical cooling and antipyretic drugs. In patients whose sputum was thick and difficult to cough up, nebulization and inhalation therapy was given, as well as effective coughing and patting the back to expel phlegm were guided.
Study NCT05930262 — intervention group
Intervention type: BEHAVIORAL
Group type: ACTIVE_COMPARATOR
Intervention: Rehabilitation therapy
Description: Comprehensive training for hemiplegic limbs included a joint range of motion training, bridging exercise, turnover training, balance training, gait training, hand function training and self-care ability training, 40 min/d, 6 times/w.
Study NCT05930262 — intervention group
Intervention type: BEHAVIORAL
Group type: EXPERIMENTAL
Intervention: Rehabilitation therapy
Description: Comprehensive training for hemiplegic limbs included a joint range of motion training, bridging exercise, turnover training, balance training, gait training, hand function training and self-care ability training, 40 min/d, 6 times/w.
Study NCT05930262 — intervention group
Intervention type: BEHAVIORAL
Group type: ACTIVE_COMPARATOR
Intervention: Breathing training
Description: Training was conducted daily in the morning, or after symptom relief in the case of fever or other discomforts, once a day, 30-40 min/time.
Study NCT05930262 — intervention group
Intervention type: BEHAVIORAL
Group type: EXPERIMENTAL
Intervention: Breathing training
Description: Training was conducted daily in the morning, or after symptom relief in the case of fever or other discomforts, once a day, 30-40 min/time.
Study NCT01763450 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: bevacizumab plus chemotherapy
Description: 1. Bevacizumab:~   7.5mg/kg, iv, on day 1 of each 21 day cycle or 5mg/kg, iv, on day 1 of each 14 day cycle;~2. Oxaliplatin+capecitabine(XELOX):( The total dose not less than 70% of the recommended dose of this standard) Oxaliplatin: 130mg/m2,d1; capecitabine: 850-1,000mg/m2，d1-d14, bid，each 21 day cycle;~3. Oxaliplatin+5-Fluorouracil+ Levomisole（FOLFOX）:~Oxaliplatin: 85mg/m2,iv for 2 hours ,d1; Levomisole（LV）: 400mg/m2,iv for 2 hours,d1; 5-Fluorouracil（5-FU） :400mg/m2 iv,d1,then 1200mg/m2/d ×2d continuous intravenous infusion(volume dose:2400mg/m2,iv for 46-48 hours ) each 14 day cycle;
Study NCT02112370 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Ropivacaine with epinephrine injection
Description: 1 mg/mL 1cc epinephrine is diluted in 100cc normal saline and then 7.5 mg/mL 30cc ropivacaine is diluted in the same normal saline. The mixture is injected into the subcutaneous layer for the initial flap dissection for the experiment group.
Study NCT02112370 — intervention group
Intervention type: OTHER
Group type: PLACEBO_COMPARATOR
Intervention: Placebo
Description: 100cc normal saline is injected into the subcutaneous layer for the initial flap dissection for the placebo group.
Study NCT00689949 — intervention group
Intervention type: DIETARY_SUPPLEMENT
Group type: OTHER
Intervention: folic acid
Description: 0.4 mg of folic acid per day
Study NCT04505098 — intervention group
Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Icosapent ethyl
Description: 2 g by mouth twice daily for at least 6 months
Study NCT04092127 — intervention group
Intervention type: OTHER
Intervention: Video Record
Description: Video Record of the premature infant face before and during the RetCam screening of retinopathy of prematurity
Study NCT03937856 — intervention group
Intervention type: BEHAVIORAL
Group type: EXPERIMENTAL
Intervention: Calm- Mindfulness Meditation smartphone application
Description: Participants will be asked to register and download the Calm application on participants' phones or home computer. Daily use for a minimum of 5 minutes will be suggested and will be recorded at study end.
Study NCT04538664 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Amivantamab
Description: Amivantamab will be administered as an IV infusion at a dose of 1400 mg (1750 mg if body weight is >=80 kilogram \[kg\]) by once weekly up to Cycle 2 Day 1, then 1750 mg (2100 mg if body weight is >=80 kg) on Day 1 of each 21-day cycle, starting with Cycle 3 and will continue the same treatment in OLE phase then in LTE phase.
Study NCT04538664 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Pemetrexed
Description: Pemetrexed will be administered as 500 mg/m\^2 IV infusion (with vitamin supplementation) on Day 1 of each 21-day cycle and then as maintenance monotherapy until disease progression in Arm A and will continue the same treatment in OLE phase then in LTE phase.
Study NCT04538664 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Carboplatin
Description: Carboplatin will be administered as AUC 5 IV infusion for up to 4 cycles on Day 1 of each 21-day cycle.
Study NCT04538664 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Pemetrexed
Description: Pemetrexed will be administered as 500 mg/m\^2 IV infusion (with vitamin supplementation) on Day 1 of each 21-day cycle and then as maintenance monotherapy until disease progression in Arm B and will continue the same treatment in OLE phase then in LTE phase.
Study NCT01573273 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Oxytocin
Description: intranasal administration, 40 IUs
Study NCT01573273 — intervention group
Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Saline
Description: intranasal administration, 40 IUs