TrialPanorama/TrialPanorama-database huggingface dataset:
Study: NCT02022007

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Metformin XR
Description: Start 2 pills (2 pills of 500 mg =1000mg XR) for 3 weeks~Increase to 4 pills as tolerated (4 pills of 500 mg XR =2000 mg XR) for remainder of study

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Saxagliptin
Description: Start 1 pill (5 mg)) for 3 weeks~Remain at 1 pill (5mg dose) for remainder of study

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Saxagliptin-Metformin XR
Description: Start 1 pill (2.5 mg/ 1000mg XR) for 3 weeks~Increase to 2 pills as tolerated (5mg/2000 mg XR) for remainder of study
Study: NCT04248855

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: KAN-101
Description: Intravenous (IV) infusion

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: KAN-101
Description: Intravenous (IV) infusion

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: KAN-101
Description: Intravenous (IV) infusion

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: KAN-101
Description: Intravenous (IV) infusion

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: KAN-101
Description: Intravenous (IV) infusion

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: KAN-101
Description: Intravenous (IV) infusion

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: KAN-101
Description: Intravenous (IV) infusion

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Placebo
Description: Intravenous (IV) infusion

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Placebo
Description: Intravenous (IV) infusion

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Placebo
Description: Intravenous (IV) infusion
Study: NCT00385541

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Morphine PCA
Description: Morphine 1mg/mL, dose 1mL, lockout 6 minutes, max 10mL

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Hydromorphone PCA
Description: hydromorphone PCA 0.2mg/lml, dose 1ml, lockout 6min, max 10ml
Study: NCT00902135

Intervention type: DRUG
Intervention: Interferon beta-1b (Betaseron, BAY86-5046)
Description: Interferon beta-1b (Betaferon) and Personal Digital Assistant together with a reminder

Intervention type: DRUG
Intervention: Interferon beta-1b (Betaseron, BAY86-5046)
Description: Interferon beta-1b (Betaferon) and Personal Digital Assistant without a reminder

Intervention type: DRUG
Intervention: Interferon beta-1b (Betaseron, BAY86-5046)
Description: Interferon beta-1b (Betaferon)
Study: NCT04272021

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Methylphenidate
Description: standard therapy for ADHD
Study: NCT03939169

Intervention type: OTHER
Group type: OTHER
Intervention: Installation of a naso-gastric feeding tube
Description: Insertion of the feeding tube with skin-to-skin contact or whilst being held in the mother's arms, or by using the four hands technique or by performing positional support with appropriate equipment

Intervention type: OTHER
Group type: OTHER
Intervention: Installation of a naso-gastric feeding tube
Description: Insertion of the feeding tube with skin-to-skin contact or whilst being held in the mother's arms, or by using the four hands technique or by performing positional support with appropriate equipment

Intervention type: OTHER
Group type: OTHER
Intervention: Installation of a naso-gastric feeding tube
Description: Insertion of the feeding tube with skin-to-skin contact or whilst being held in the mother's arms, or by using the four hands technique or by performing positional support with appropriate equipment

Intervention type: OTHER
Group type: OTHER
Intervention: Installation of a naso-gastric feeding tube
Description: Insertion of the feeding tube with skin-to-skin contact or whilst being held in the mother's arms, or by using the four hands technique or by performing positional support with appropriate equipment
Study: NCT03734965

Intervention type: DEVICE
Group type: ACTIVE_COMPARATOR
Intervention: AWAKEN INTUBATION
Description: Intubation

Intervention type: DEVICE
Group type: EXPERIMENTAL
Intervention: AWAKEN INTUBATION
Description: Intubation
Study: NCT02725970

Intervention type: OTHER
Intervention: survey
Description: Cross-sectional survey

Intervention type: OTHER
Intervention: survey
Description: Cross-sectional survey

Intervention type: OTHER
Intervention: survey
Description: Cross-sectional survey

Intervention type: OTHER
Intervention: survey
Description: Cross-sectional survey

Intervention type: OTHER
Intervention: survey
Description: Cross-sectional survey

Intervention type: OTHER
Intervention: survey
Description: Cross-sectional survey
Study: NCT04217278

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Vyxeos
Description: Vyxeos administered by intravenous infusion

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Fludarabine
Description: Fludarabine administered by intravenous infusion
Study: NCT02785640

Intervention type: BEHAVIORAL
Group type: EXPERIMENTAL
Intervention: Hourly prompts to stand delivered by Microsoft Outlook
Description: Prompt group
Study: NCT04217278

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Fludarabine
Description: Fludarabine administered by intravenous infusion

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Fludarabine
Description: Fludarabine administered by intravenous infusion

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Fludarabine
Description: Fludarabine administered by intravenous infusion

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Busulphan
Description: Busulphan administered by intravenous infusion

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Busulphan
Description: Busulphan administered by intravenous infusion

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Busulphan
Description: Busulphan administered by intravenous infusion

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Busulphan
Description: Busulphan administered by intravenous infusion

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Thiotepa
Description: Thiotepa administered by intravenous infusion

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Thiotepa
Description: Thiotepa administered by intravenous infusion

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Cytarabine
Description: Cytarabine administered by intravenous infusion
Study: NCT03297515

Intervention type: DIETARY_SUPPLEMENT
Group type: EXPERIMENTAL
Intervention: Madeos
Description: Arm 1: Omega 3

Intervention type: DIETARY_SUPPLEMENT
Group type: PLACEBO_COMPARATOR
Intervention: Placebo
Description: Arm 2 : Placebo
Study: NCT00652158

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: MLN8054
Description: 10 mg doses of MLN8054 were given orally once daily following a schedule of 5 days on/2 days off/5 days on repeated every 28 days
Study: NCT02489955

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Amikacin

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Tobramycin

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Colomycin
Study: NCT01168193

Intervention type: OTHER
Group type: OTHER
Intervention: No intervention
Study: NCT03852563

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: BAY207543 (Bepanthol)
Description: Product is applied to one hemiface.

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: BAY207543 (Bepanthol)
Description: Product is applied to one hemiface.

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: Semisolid vaseline
Description: Product is applied to one hemiface.

Intervention type: OTHER
Group type: ACTIVE_COMPARATOR
Intervention: Semisolid vaseline
Description: Product is applied to one hemiface.
Study: NCT03182699

Intervention type: DIAGNOSTIC_TEST
Group type: ACTIVE_COMPARATOR
Intervention: cardiac MRI
Description: non contrast heart MRI at baseline and after 1 year of therapy

Intervention type: DIAGNOSTIC_TEST
Group type: EXPERIMENTAL
Intervention: cardiac MRI
Description: non contrast heart MRI at baseline and after 1 year of therapy

Intervention type: DIAGNOSTIC_TEST
Group type: ACTIVE_COMPARATOR
Intervention: echocardiography with strain
Description: echocardiography at baseline and after 1 year of therapy
Study: NCT02320357

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Treatment by clopidogrel
Description: Peripheral blood will be obtained during the study
Study: NCT02456909

Intervention type: DEVICE
Group type: EXPERIMENTAL
Intervention: Patient-Controlled Analgesia pump with Cues
Description: The end of the lockout period will be cued via the PCA pump

Intervention type: DEVICE
Group type: PLACEBO_COMPARATOR
Intervention: Patient-Controlled Analgesia pump without Cues
Description: The PCA pump will be programmed such that no cues will be provided to the end of the lockout period.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Morphine
Description: Morphine will be administered for post-operative pain in both the Cues and Non-Cues groups

Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Morphine
Description: Morphine will be administered for post-operative pain in both the Cues and Non-Cues groups
Study: NCT04604639

Intervention type: DIAGNOSTIC_TEST
Intervention: NEWS2 score
Description: Patients seen by ambulance crews within the preceeding 48 hrs of their cardiac arrest will have a NEWS2 score performed to assess the level of physiological deterioration at the time of thei intial assessment.
Study: NCT00929708

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: AZD3199
Description: Dry powder for inhalation, o.d., 4 weeks

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: AZD3199
Description: Dry powder for inhalation, o.d., 4 weeks

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: AZD3199
Description: Dry powder for inhalation, o.d., 4 weeks

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: formoterol
Description: Dry powder for inhalation, b.i.d., 4 weeks

Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Placebo
Description: Dry powder for inhalation, b.i.d., 4 weeks
Study: NCT00721058

Intervention type: OTHER
Group type: OTHER
Intervention: CT-scan
Description: A pre-operative CT-scan will be made
Study: NCT01687309

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: GSK2586184 800mg single and repeat dose
Description: GSK2586184 800mg single dose and then twice daily dosing for 13 days

Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Placebo-to-match GSK2586184
Description: Placebo-to-match GSK2586184

Intervention type: OTHER
Group type: OTHER
Intervention: GSK2586184 single dose taken with food
Description: GSK2586184 single dose taken with FDA approved high fat, high calorie breakfast

Intervention type: OTHER
Group type: OTHER
Intervention: GSK2586184 single dose taken without food
Description: GSK2586184 single dose taken in a fasted state
Study: NCT03182699

Intervention type: DIAGNOSTIC_TEST
Group type: EXPERIMENTAL
Intervention: echocardiography with strain
Description: echocardiography at baseline and after 1 year of therapy

Intervention type: DIAGNOSTIC_TEST
Group type: ACTIVE_COMPARATOR
Intervention: Laboratory tests
Description: drawing blood from dialysis machine

Intervention type: DIAGNOSTIC_TEST
Group type: EXPERIMENTAL
Intervention: Laboratory tests
Description: drawing blood from dialysis machine

Intervention type: DIAGNOSTIC_TEST
Group type: ACTIVE_COMPARATOR
Intervention: Body composition monitoring
Description: Measurement with BCM (Fresenius) machine

Intervention type: DIAGNOSTIC_TEST
Group type: EXPERIMENTAL
Intervention: Body composition monitoring
Description: Measurement with BCM (Fresenius) machine

Intervention type: DIAGNOSTIC_TEST
Group type: ACTIVE_COMPARATOR
Intervention: lung ultrasound
Description: ultrasound

Intervention type: DIAGNOSTIC_TEST
Group type: EXPERIMENTAL
Intervention: lung ultrasound
Description: ultrasound
Study: NCT01169714

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: 0.1 mg PF-04995274
Description: 0.1 mg PF-04995274, qd, for 14 days or placebo

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: 1 mg PF-04995274
Description: 1 mg PF-04995274, qd, for 14 days or placebo

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: 10 mg PF-04995274
Description: 10 mg PF-04995274, qd, for 14 days or placebo

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: 15 mg PF-04995274
Description: 15 mg PF-04995274, qd, for 14 days or placebo

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: 1.0 mg PF-04995274
Description: 1.0 mg PF-04995274, qd, for 14 days or placebo

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: 15 mg PF-04995274
Description: 15 mg PF-04995274, qd, for 14 days or placebo
Study: NCT02758353

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Community distribution of SP
Description: SP delivered at both the community and facility level by trained CBHVs in three LGAs.
Study: NCT02465281

Intervention type: OTHER
Intervention: Device: 3T scanner with MRI-compatible robot

Intervention type: OTHER
Intervention: Device: 3T scanner with MRI-compatible robot
Study: NCT02422602

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Xarelto
Description: Taking conventional charge

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: Experimental: Personalized information intervention
Study: NCT03026790

Intervention type: OTHER
Group type: ACTIVE_COMPARATOR
Intervention: Medication management
Description: Individualized management of medications for pain

Intervention type: OTHER
Group type: ACTIVE_COMPARATOR
Intervention: Medication management
Description: Individualized management of medications for pain

Intervention type: OTHER
Group type: ACTIVE_COMPARATOR
Intervention: Medication management
Description: Individualized management of medications for pain

Intervention type: OTHER
Group type: ACTIVE_COMPARATOR
Intervention: Medication management
Description: Individualized management of medications for pain

Intervention type: OTHER
Group type: ACTIVE_COMPARATOR
Intervention: Non-pharmacological pain management
Description: Individualized management of non-medication pain treatment approaches

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Buprenorphine-Naloxone
Description: Option of using buprenorphine-naloxone to assist with opioid dose reduction or discontinuation
Study: NCT00800839

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Busulfan
Description: Starting dose of 32 mg/m\^2 by vein over 3 hours each day. Test dose day -8 (inpatient) or test dose day -30 to day -8 (outpatient) and then, days -6,-5,-4, and -3.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Fludarabine
Description: Dose of 40 mg/m\^2 by vein over 1 hour each day on Day -6 through Day -3 before receiving Busulfan.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Cyclophosphamide
Description: Dose of 50 mg/kg by vein over 3 hours on Days 3 and 4.
Study: NCT01514214

Intervention type: DEVICE
Group type: ACTIVE_COMPARATOR
Intervention: WInged perimeter biliary stent insertion (Viaduct)
Description: Insertion of a winged perimeter stent. Size to be determined during the ERCP based on findings.

Intervention type: DEVICE
Group type: ACTIVE_COMPARATOR
Intervention: traditional polyethylene stent insertion (Cotton Huibregtse)
Description: insertion of a traditional polyethylene stent during ERCP, size to be determined depending on findings during ERCP
Study: NCT03977675

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Ketamine
Description: Patients are assigned to one of three ketamine doses (0.3, 0.5, or 0.7 mg/kg) that will be administered intravenously.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Ketamine
Description: Patients are assigned to one of three ketamine doses (0.3, 0.5, or 0.7 mg/kg) that will be administered intravenously.
Study: NCT01579084

Intervention type: DRUG
Group type: OTHER
Intervention: AGN-199201 Vehicle
Description: AGN-199201 vehicle (placebo) applied to the face as per protocol twice daily.

Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: AGN-199201 Vehicle
Description: AGN-199201 vehicle (placebo) applied to the face as per protocol twice daily.
Study: NCT04790461

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: Pre-post test
Description: Adult Caregiver Quality of Life Questionnaire (AC-QoL) Perceived Stress Scale (PSS) The Stress Coping Styles Questionnaire (SCSQ)
Study: NCT03977675

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Ketamine
Description: Patients are assigned to one of three ketamine doses (0.3, 0.5, or 0.7 mg/kg) that will be administered intravenously.
Study: NCT02130934

Intervention type: PROCEDURE
Intervention: Cardiac 3D MRI
Study: NCT03329287

Intervention type: BEHAVIORAL
Group type: EXPERIMENTAL
Intervention: SCBT
Description: SCBT, one hour per session.

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: SSRIs and/or SNRIs
Description: SSRIs and/or SNRIs at a recommended dosage.

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: SSRIs and/or SNRIs
Description: SSRIs and/or SNRIs at a recommended dosage.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: SSRIs and/or SNRIs
Description: SSRIs and/or SNRIs at a recommended dosage.

Intervention type: BEHAVIORAL
Group type: ACTIVE_COMPARATOR
Intervention: Psychological Placebo
Description: Supportive and relaxation therapy, one our per session.
Study: NCT02525848

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: dexamethasone
Description: dexamethasone 8 mg iv 2 minutes before induction of anesthesia

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: dexamethasone
Description: dexamethasone 8 mg iv 2 minutes before induction of anesthesia

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: dexamethasone
Description: dexamethasone 8 mg iv 2 minutes before induction of anesthesia

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Gabapentin
Description: oral gabapentin 600 mg 1 hour before induction of anesthesia

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Aprepitant
Description: oral aprepitan 80mg 1 hour before induction of anesthesia.
Study: NCT05790538

Intervention type: PROCEDURE
Intervention: Assessment of Therapy Complications
Description: Complete clinic assessments

Intervention type: OTHER
Intervention: Electronic Health Record Review
Description: Medical records are reviewed

Intervention type: OTHER
Intervention: Medical Device Usage and Evaluation
Description: Wear SmartSocks

Intervention type: OTHER
Intervention: Medical Device Usage and Evaluation
Description: Wear activity monitor

Intervention type: OTHER
Intervention: Survey Administration
Description: Complete survey
Study: NCT02281799

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Azathioprine
Description: Patients will be commenced on an alternative thiopurine to that used initially, according to the standard dosing schedule used by their IBD clinician.~For example, if the initial thiopurine-related pancreatitis occurred while taking Azathioprine, the patient will be restarted on 6-MP, and vice versa.
Study: NCT04110405

Intervention type: BEHAVIORAL
Group type: EXPERIMENTAL
Intervention: Stepped Care
Description: This stepped care model involves three steps. Step 1 is a peer and nurse co-led 8-session group based upon BRIDGES. Step 2 is peer or nurse led 6-session individual meetings based upon Interpersonal Psychotherapy. Step 3 is primary care physician led medication treatment with Amitriptyline.

Intervention type: BEHAVIORAL
Group type: ACTIVE_COMPARATOR
Intervention: Standard of Care plus Healthy Lifestyle
Description: Standard outpatient care supplemented with literature on healthy lifestyles will serve as an enhanced control condition. In each clinic, non-specialty mental health care is available in the form of counseling from doctors or nurses along with psychiatric medication management. Given the difficulties faced by women in Tajikistan, ethical responsibility compels us to enhance the control condition by having nurses distribute written materials on healthy eating, physical fitness, and personal hygiene, at a reading level which will be widely accessible.
Study: NCT01034267

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: F2695 SR
Description: Drug F2695 SR (flexible dose) to be given orally in capsule form once daily
Study: NCT03176420

Intervention type: PROCEDURE
Group type: EXPERIMENTAL
Intervention: angioplasty and stenting of occluded cervical ICA
Description: The procedure is performed under monitored anesthetic care. We will perform a thorough and complete six-vessel diagnostic angiogram to completely characterize the occlusion and presence of collaterals. A distal protection device is used unless technically can't be delivered beyond the occlusion or when the occlusion extends beyond the petrous segment of the internal carotid artery. Balloon angioplasty is performed followed by deployment of covered stents to jail the clot/organized thrombus. The carotid reconstruction is performed from the distal to the proximal segment with coronary stents that are telescoped until normal flow is encounter. The Blood pressure is managed rigorously during and after the procedure to minimize the chances of reperfusion hemorrhage.
Study: NCT01459432

Intervention type: OTHER
Intervention: Venepuncture and blood sample collection.
Description: Venepuncture and blood sample collection.
Study: NCT01452633

Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: 0.25% bupivicaine will be injected at the study port site prior to incision
Description: Injection will precede the incision

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: 0.25% bupivicaine will be injected at the study port site prior to incision
Description: Injection will precede the incision

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: 0.25% bupivicaine will be injected at the study port site prior to incision
Description: Injection will precede the incision

Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Saline will be injected at the study port site prior to incision
Description: Injection will precede incision

Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Saline will be in injected into the port site prior to closure
Description: Saline will be injected into the port site prior to the closure without any preincisional intervention

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: 0.25% bupivicaine will be injected into the port site prior to closure
Description: 0.25% bupivicaine will be injected into the port site at closure without any preincisional intervention
Study: NCT03044483

Intervention type: OTHER
Intervention: Measurement of sublingual microcirculatory parameters
Description: Measurement of the sublingual microcirculatory function using the CytoCam-IDF imaging device to establish the normal range for each age group noted.
Study: NCT01615107

Intervention type: DEVICE
Group type: EXPERIMENTAL
Intervention: COOK RIPENENIG BALLOON+PITOCN
Description: GROUP 2: insertion of the double balloon device and concurrent oxytocin administration.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: PITOCIN
Description: : Oxytocin infusion alone (Standard Protocol