AIM-Harvard/TrialPanorama-filtered huggingface dataset:
Study NCT02579317 — intervention group
Intervention type: BEHAVIORAL
Group type: PLACEBO_COMPARATOR
Intervention: Non-Resonance Breathing
Description: Breathing is paced with a pre-installed iPhone app that includes a visual pacer.
Study NCT03402672 — intervention group
Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: self-administered, e-health application
Description: AWAITS is a self-administered, e-health application and includes short videos in which patients who are successfully engaged in MAT discuss what they wish they had known about MAT when they were actively using. The intervention is designed to maximize scalability - the administration would entail handing an electronic device (e.g., tablet, laptop, etc.) to an individual who would then self-administer the intervention.
Study NCT01392456 — intervention group
Intervention type: PROCEDURE
Group type: ACTIVE_COMPARATOR
Intervention: Insertion of two screw type dental implants
Description: Each patient (of the 69 recruited) will receive 2 screw-type Straumann (Institute Straumann AG, Basel, Switzerland) standard implants Ø4.1 mm, with SLA surface in the canine region of the mandible with an interconnecting line approaching parallelism with the terminal mandibular hinge axis, in a 1-stage non-submerged procedure according to a strict protocol (Weingart D and ten Bruggenkate 2000).
Study NCT03023540 — intervention group
Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: PXT3003
Description: Liquid oral solution, twice 5 mL (Dose 1) bid
Study NCT02453659 — intervention group
Intervention type: BEHAVIORAL
Group type: EXPERIMENTAL
Intervention: Distress Tolerance Treatment for Weight Concern (DT-W)
Study NCT02453659 — intervention group
Intervention type: BEHAVIORAL
Group type: ACTIVE_COMPARATOR
Intervention: Health Education (HE)
Study NCT02453659 — intervention group
Intervention type: BEHAVIORAL
Group type: EXPERIMENTAL
Intervention: Smoking Cessation counseling
Study NCT02453659 — intervention group
Intervention type: BEHAVIORAL
Group type: ACTIVE_COMPARATOR
Intervention: Smoking Cessation counseling
Study NCT02453659 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Transdermal Nicotine Patch
Study NCT02453659 — intervention group
Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Transdermal Nicotine Patch
Study NCT04656678 — intervention group
Intervention type: DEVICE
Group type: EXPERIMENTAL
Intervention: Cryo-ablation Using DynaCAD / UroNAV preplanning / guidance
Description: Focal ultrasound guided cryoablation using uroNav system Version 4.0 and Dyna CAD software version 5.0.
Study NCT01030471 — intervention group
Intervention type: BEHAVIORAL
Group type: EXPERIMENTAL
Intervention: Family-based cognitive-behavioral treatment
Description: Participants will engage in ten weekly sessions aimed at improving depressive symptoms and medication compliance via reducing family conflict and improving communication among family members.
Study NCT01544192 — intervention group
Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Gingko Biloba
Description: 2x60 mg Gingko Biloba (Vega Natural, Konya, Turkey)
Study NCT01544192 — intervention group
Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: α-tocopherol
Description: 2x300 mg α-tocopherol
Study NCT01544192 — intervention group
Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Placebo
Description: control group did not receive oral neuroprotective agent
Study NCT01544192 — intervention group
Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Antioxidant formula
Description: 2x1 tablet AOF
Study NCT00814541 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Bortezomib
Study NCT00814541 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Doxorubicin
Study NCT00814541 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Dexamethasone
Study NCT02336347 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: AVP-786
Study NCT02336347 — intervention group
Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: AVP-923
Study NCT01463358 — intervention group
Intervention type: DEVICE
Group type: ACTIVE_COMPARATOR
Intervention: DDD60 (INSIGNIA® pacing systems Guidant (Boston Scientific)
Description: pacing in DDD60 is supposed to prevent events of syncope, presyncope of cardioinhibitory origin and symptom associated to av block
Study NCT01463358 — intervention group
Intervention type: DEVICE
Group type: OTHER
Intervention: DDD60 (INSIGNIA® pacing systems Guidant (Boston Scientific)
Description: pacing in DDDI30 is supposed to act as a safety backup upfront to episodes of syncope, presyncope or AV block, but not supposed to reduce symptoms.
Study NCT03973697 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Penn Microbiome Therapy - 001
Description: Fecal Microbiota for Transplant, enema product
Study NCT03973697 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Penn Microbiome Therapy - 002
Description: Fecal Microbiota for Transplant, suspension product
Study NCT03973697 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Penn Microbiome Therapy - 003
Description: Fecal Microbiota for Transplant, capsule product
Study NCT00630201 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Probuphine (buprenorphine implant)
Description: Implantable formulation of buprenorphine made of buprenorphine HCl/ethylene vinyl acetate, considered a drug. (4 implants, 6-month duration).
Study NCT02024737 — intervention group
Intervention type: OTHER
Intervention: MRI lung imaging (not an intervention per se but the focus of the study)
Description: The purpose of this pilot study is to determine short and long term reproducibility of a comprehensive set of functional imaging data; using hyperpolarised gas MRI, conventional MRI and lung physiology measurements in patients with moderate to severe COPD. In addition,how sensitive the imaging techniques are to changes in lung function after treatment with a standard (bronchodilator) inhaler will also be assessed (the bronchodilator foradil is a non-investigative medicinal product as it is a medicine with a known effect which will be used to induce a known response).~This pilot study will serve as a platform for future larger scale studies, aimed at better understanding of and intervention in early COPD.
Study NCT04037852 — intervention group
Intervention type: DEVICE
Group type: EXPERIMENTAL
Intervention: robotic assisted nipple sparing mastectomy
Description: R-NSM, which introduce da Vinci surgical platform through a small extra-mammary axillary or lateral chest wound to perform NSM, had been applied in the surgical treatment of early breast cancer or risk reducing mastectomy. R-NSM, which incorporated 3-dimensional (3D) imaging system and flexibility of robotic arm and instruments, was reported to have the potential to overcome the technique difficulty of E-NSM.
Study NCT04037852 — intervention group
Intervention type: PROCEDURE
Group type: ACTIVE_COMPARATOR
Intervention: Endoscopic assisted nipple sparing mastectomy
Description: E-NSM, which is performed through small axillary and/or peri-areolar incisions, was reported to be associated with small inconspicuous incision and good cosmetic outcome. Conventional E-NSM was performed with two separate incisions over axilla and peri-areolar regions. E-NSM with areolar incision, just like NSM with areolar related incision (NAC ischemia/necrosis rate: range 7%-81.8%), was associated with increased NAC ischemia/necrosis (reported ranged: 9.1-19%). New technique modifications of E-NSM were emerging focusing on single axillary incision NSM, which spare the peri-areolar incision and thereby decrease the compromise of bloody supply from mastectomy skin flap, was reported to have low NAC necrosis rate (0%).
Study NCT04037852 — intervention group
Intervention type: PROCEDURE
Group type: ACTIVE_COMPARATOR
Intervention: Conventional nipple sparing mastectomy
Description: Nipple-sparing mastectomy (NSM), which preserved the nipple areolar complex (NAC) and skin flap during mastectomy, was increasingly performed in breast cancer patients due to better cosmetic outcome, higher patient satisfaction, and maintained oncologic safety.
Study NCT02550080 — intervention group
Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Dapsone
Description: For the HLA-B\*1301 positive subjects, dapsone will not be administrated.
Study NCT02550080 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Dapsone
Description: For the HLA-B\*1301 positive subjects, dapsone will not be administrated.
Study NCT02550080 — intervention group
Intervention type: GENETIC
Group type: EXPERIMENTAL
Intervention: HLA-B*1301
Description: The prospective genetic screening group will be tested before administrating dapsone
Study NCT04554758 — intervention group
Intervention type: PROCEDURE
Group type: EXPERIMENTAL
Intervention: Sleeve gastrectomy
Description: Bariatric operation will be done by laparoscopic sleeve gastrectomy procedure.
Study NCT04554758 — intervention group
Intervention type: PROCEDURE
Group type: EXPERIMENTAL
Intervention: Roux-en-Y gastric bypass
Description: Bariatric operation will be done by laparoscopic Roux-en-Y gastric bypass procedure.
Study NCT03174288 — intervention group
Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: Exercise
Description: 24 weeks of exercise treatment
Study NCT03174288 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Spironolactone
Description: 24 weeks of spironolactone
Study NCT03765229 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Entinostat
Description: Oral drug 5 mg taken once weekly for up to nine 3-week (21 day) cycles. Take on an empty stomach i.e., at least 2 hours after a meal and at least 1 hour before the next meal. On days when entinostat is administered on the same day as pembrolizumab, entinostat should be taken before the pembrolizumab infusion.
Study NCT03765229 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Pembrolizumab
Description: 200 mg IV starting on Day 22 (cycle 2, Day 1) given every 3 weeks for up to 8 cycles.
Study NCT01039805 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: GSK962040 (50 mg)
Description: Cohort 1 = 50 mg
Study NCT01039805 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Placebo
Description: matching placebo
Study NCT01039805 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: GSK962040 (75 mg)
Description: Cohort 2 = 75 mg
Study NCT01899105 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: lumacaftor
Study NCT01899105 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: ivacaftor
Study NCT03896178 — intervention group
Intervention type: OTHER
Intervention: None, observational study
Description: None, observational study
Study NCT02994641 — intervention group
Intervention type: PROCEDURE
Intervention: COMA Score Assessment
Study NCT04290325 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: HMPL-453
Description: HMPL-453 tablet
Study NCT01315795 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Lanreotide Autogel 90 mg and 120 mg
Description: administration of lanreotide sc every 4 weeks (28 days)
Study NCT02485418 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Propofol
Description: Intravenous propofol infusion at 20 mcg/kg/min for 10 minutes, followed by an increase to 30 mcg/kg/min for 10 minutes and then by an increase to 40 mcg/kg/min for 40 minutes.
Study NCT01229813 — intervention group
Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: bevacizumab, erlotinib
Description: bevacizumab 7.5 mg/kg body weight every third week, erlotinib 150 mg daily
Study NCT01229813 — intervention group
Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: bevacizumab
Description: bevacizumab 7.5 mg/kg body weight every third week
Study NCT01229813 — intervention group
Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: bevacizumab
Description: bevacizumab 7.5 mg/kg body weight every third week.
Study NCT01229813 — intervention group
Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: low dose capecitabine
Description: capecitabine 500 mg twice daily
Study NCT02256306 — intervention group
Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: Plasma
Description: 1 unit of Plasma From Young Donors (Male, aged 30 or younger)
Study NCT02704559 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: DWC20155
Study NCT02704559 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: DWC20156
Study NCT03338244 — intervention group
Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Azithromycin
Description: Children aged 1 month to 60 months per community will be offered weight or height-based, directly observed, oral azithromycin suspension every 6 months
Study NCT03338244 — intervention group
Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Placebo
Description: Children aged 1 month to 60 months per community will be offered weight or height-based, directly observed, oral placebo suspension every 6 months
Study NCT02181218 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Romidepsin
Study NCT02181218 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Gemcitabine
Study NCT04749498 — intervention group
Intervention type: OTHER
Group type: ACTIVE_COMPARATOR
Intervention: White Bread
Description: Test breakfast with white bread was served after 12-hours of fasting and participants were asked to consume the meal in full, within 15 minutes.
Study NCT04749498 — intervention group
Intervention type: OTHER
Group type: ACTIVE_COMPARATOR
Intervention: Whole Wheat Bread
Description: In a crossover design, this bread was served with a standard breakfast to compare other breads.
Study NCT04749498 — intervention group
Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: Barley Bread
Description: In a crossover design, this bread was served with a standard breakfast to compare other breads.
Study NCT04749498 — intervention group
Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: Oat Bread
Description: In a crossover design, this bread was served with a standard breakfast to compare other breads.
Study NCT02886598 — intervention group
Intervention type: DRUG
Intervention: degarelix
Study NCT02164006 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: TGR-1202 + brentuximab vedotin
Description: TGR-1202 an oral daily dose with an IV infusion of brentuximab vedotin
Study NCT02420041 — intervention group
Intervention type: PROCEDURE
Group type: ACTIVE_COMPARATOR
Intervention: Active comparator: Fluoroscopic Guided SIJ injection
Description: * Needle entry point is in the lower one-third of the SIJ~* Sterile preparation (with chlorhexidine) and draping and 3 mL of 1% lidocaine injected subcutaneously at site of needle entry~* Under fluoroscopy guidance, Havel's Inc. EchoStim (facet tip) 21 Gauge 4 needle is inserted in a coaxial fashion into the SIJ~* 1 mL of contrast (iohexol 300 mg/mL) is injected to outline the SIJ and to ensure no vascular uptake~* Injection of 20 mg of triamcinolone diluted in 4 mL of 1% lidocaine~* Patient observed in recovery bay for 20 minutes and then discharged home
Study NCT02420041 — intervention group
Intervention type: PROCEDURE
Group type: EXPERIMENTAL
Intervention: Ultrasound Guided Sacroiliac Joint Injection
Description: * Sterile preparation (with chlorhexidine) and drape~* Using ultrasound guidance (SonoSite S-nerve) with a low frequency (2-5 Hz) curvilinear transducer in a sterile cover, the transducer is placed in a transverse plane over the SIJ and needle entry point is chosen at the medial end of the ultrasound transducer~* 3 mL of 1% lidocaine is injected subcutaneously at site of needle entry~* Under ultrasound guidance, a Havel's Inc. EchoStim (facet tip) 21 Gauge 4 needle is inserted in a medial to lateral direction and guided into the SIJ. (0.5-2 mL of normal saline may be injected during needle insertion to locate tip of needle and to ensure solution does not spill out onto sacrum).~* After using the Doppler function to identify any surrounding vessels (to avoid intravascular injection), 20 mg of triamcinolone diluted in 4 mL of 1% lidocaine is injected.~* Patient observed in recovery bay for 20 minutes and then discharged home
Study NCT02420041 — intervention group
Intervention type: DEVICE
Group type: ACTIVE_COMPARATOR
Intervention: Havel's Inc. EchoStim (facet tip) 21 Gauge 4 needle
Study NCT02420041 — intervention group
Intervention type: DEVICE
Group type: EXPERIMENTAL
Intervention: Havel's Inc. EchoStim (facet tip) 21 Gauge 4 needle
Study NCT02181218 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Oxaliplatin
Study NCT02181218 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Dexamethasone
Study NCT02181218 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Pegfilgrastim
Study NCT02420041 — intervention group
Intervention type: DEVICE
Group type: EXPERIMENTAL
Intervention: SonoSite S-nerve
Study NCT02420041 — intervention group
Intervention type: DEVICE
Group type: ACTIVE_COMPARATOR
Intervention: iohexol
Study NCT02420041 — intervention group
Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: triamcinolone/lidocaine
Study NCT02420041 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: triamcinolone/lidocaine
Study NCT01518088 — intervention group
Intervention type: DIETARY_SUPPLEMENT
Group type: EXPERIMENTAL
Intervention: Dietary Fiber
Description: Dietary fiber will be added to study foods
Study NCT01518088 — intervention group
Intervention type: DIETARY_SUPPLEMENT
Group type: PLACEBO_COMPARATOR
Intervention: Dietary Fiber
Description: Dietary fiber will be added to study foods
Study NCT01902498 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Aspirin
Description: Aspirin 81mg po daily x 7days or end of hospitalization. First dose administered on post op day 1.
Study NCT01902498 — intervention group
Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Aspirin
Description: Aspirin 325mg po daily x 7days or end of hospitalization. First dose administered on post op day 1.
Study NCT01902498 — intervention group
Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Aspirin
Description: Aspirin 162mg po twice daily x 7days or end of hospitalization. First dose administered on post op day 1.
Study NCT03049345 — intervention group
Intervention type: PROCEDURE
Group type: EXPERIMENTAL
Intervention: Sentinel Lymph Node Sampling
Description: The day before surgery, 2mL of endoscopically-placed technetium 99m sulfur colloid solution will be injected submucosally at 4 points around the tumour. At the time of surgery, 2cc of 1% isosulfan blue dye will be similarly injected. Laparoscopically, the gastrocolic ligament will be opened to expose all gastric lymph node drainage basins. Using visual inspection and a laparoscopic gamma probe, blue nodes and those emitting 10x greater than background activity will be considered sentinel nodes and extracted. Sentinel lymph nodes and resected specimens will be analyzed by permanent section.
Study NCT03049345 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Radioactive Tracers
Description: see above
Study NCT03049345 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Methylene Blue 20 MG/ML
Description: see above
Study NCT00665223 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: ACR16
Description: Capsules will be swallowed whole with water.
Study NCT00665223 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Placebo
Description: Capsules will be swallowed whole with water.
Study NCT00665223 — intervention group
Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Placebo
Description: Capsules will be swallowed whole with water.
Study NCT01278615 — intervention group
Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: Laboratory Biomarker Analysis
Description: Correlative studies
Study NCT01278615 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Selumetinib
Description: Given PO
Study NCT04117815 — intervention group
Intervention type: DEVICE
Intervention: Paxman Scalp Cooling System
Description: All patients who accomplish inclusion criteria and do not exhibit any contraindication undergo scalp cooling with the following conditions:~* Minimum 30 minutes pre-infusion cooling~* Cooling for the duration of chemotherapy infusion~* Minimum 90 minutes post-infusion cooling Scalp cooling is performed within the study group at each CT session.
Study NCT04117815 — intervention group
Intervention type: OTHER
Intervention: Alopecia Assessments
Description: Patients (study group and reference group) will be assessed at the following time Points:~* Baseline~* at the half-way Point of the cyles~* at the last CT cycle~* 3 months after completion of Treatment~* 6-9 months after treatment completion~The assesments include the following~* Photographs of the head, which are evaluated using the CTCAEv4.0~* Questionnaire including the NCI- PRO-CTCAE-ITEMS, EORTC QLQ-C30, EORTC QLQ-B23, Body Image Scale, PRO-CTACAEs and Hairdex questionnaire
Study NCT01803347 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: ◦Drug: ASCs. + fibrin glue
Description: Experimental group
Study NCT01803347 — intervention group
Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: fibrin glue
Description: •Active Comparator: Fibrin glue Intervention: Drug: Fibrin adhesive
Study NCT03980990 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Metformin
Description: Continuation of Metformin
Study NCT01586975 — intervention group
Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Clopidogrel
Description: Clopidogrel 75 mg QD
Study NCT01586975 — intervention group
Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Aspirin 81 mg
Description: Aspirin 81mg QD
Study NCT01586975 — intervention group
Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Aspirin >300 mg
Description: Aspirin >300 mg QD
Study NCT01432522 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Epinephrine
Description: 1. Intranasal epinephrine 5 mg /spray~2. Intramuscular epinephrine 0.3 mg~3. Intranasal saline spray
Study NCT04756206 — intervention group
Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Dutasteride 0.5 mg
Description: patients were randomized into 2 equal groups with 1:1 ratio using a computer-based system. Dutasteride of 0.5 mg once daily was given for 3 months compared to a placebo. Patients, data collector,s and the statistician were blinded to the type of intervention.
Study NCT04756206 — intervention group
Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Placebo
Description: patients were randomized into 2 equal groups with 1:1 ratio using a computer-based system. Dutasteride of 0.5 mg once daily was given for 3 months compared to a placebo. Patients, data collector,s and the statistician were blinded to the type of intervention.