TrialPanorama/TrialPanorama-database huggingface dataset:
Study: NCT01822613

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: LJM716
Description: LJM716 (10-40 mg/kg) will be given as a once weekly infusion beginning on cycle 1 day 1. The doses of LJM716 will be increased as dose escalation proceeds until a maximum tolerated dose (MTD) and/or recommended phase II dose (RP2D) is established.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: BYL719
Description: BYL719 (200-400 mg) will be administered orally on a once daily schedule starting cycle 1 day 1. The doses of BYL719 will be increased as dose escalation proceeds until a maximum tolerated dose (MTD) and/or recommended phase II dose (RP2D) is established.

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Paclitaxel
Description: In the Phase II portion of the study Paclitaxel is one of the 3 physician's choice drug which allows single-agent paclitaxel to be used per manufacturer's label.

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Docetaxel
Description: In the Phase II portion of the study Docetaxel is one of the 3 physician's choice drug which allows single-agent docetaxel to be used per manufacturer's label.

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Irinotecan
Description: In the Phase II portion of the study Irinotecan is one of the 3 physician's choice drug which allows single-agent irinotecan to be used per manufacturer's label
Study: NCT03584555

Intervention type: PROCEDURE
Group type: ACTIVE_COMPARATOR
Intervention: SMILE using 120μm cap thickness
Description: The surgery was performed with standardized techniques with triple centration technique using the 500-KHz VisuMax system (Carl Zeiss Meditec AG, Jena, Germany). The superior cap depth was set as 120 or 140 µm, and the length of the side cut was set to 2 mm. Once the anterior (upper) and posterior (lower) planes of the lenticule were defined, the anterior and posterior interfaces were dissected using a micropetala with a blunt circular tip and extracted with midforceps. The integrity of the lenticule was assessed subsequently.
Study: NCT00589316

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Cyclophosphamide
Description: Given IV
Study: NCT03584555

Intervention type: PROCEDURE
Group type: ACTIVE_COMPARATOR
Intervention: SMILE using 140μm cap thickness
Description: The surgery was performed with standardized techniques with triple centration technique using the 500-KHz VisuMax system (Carl Zeiss Meditec AG, Jena, Germany). The superior cap depth was set as 120 or 140 µm, and the length of the side cut was set to 2 mm. Once the anterior (upper) and posterior (lower) planes of the lenticule were defined, the anterior and posterior interfaces were dissected using a micropetala with a blunt circular tip and extracted with midforceps. The integrity of the lenticule was assessed subsequently.
Study: NCT02337855

Intervention type: OTHER
Group type: PLACEBO_COMPARATOR
Intervention: Placebo
Description: Placebo: normal saline for parenteral administration. Group C. Group F, and Group I: single dose intramuscular (IM) Placebo (normal saline (0.9% NaCl) on Day 1, 57 and 113.

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: Sm-TSP-2/Alhydrogel
Description: Sm-TSP-2/Alhydrogel. Group A: single dose IM 10mcg Sm-TSP-2/Alhydrogel® on Day1, 57 and 113. Group D: single dose intramuscular (IM) 30mcg Sm-TSP-2/Alhydrogel® on Day 1, 57 and 113. Group G: single dose intramuscular (IM) 100mcg Sm-TSP-2/Alhydrogel® on Day 1, 57 and 113.
Study: NCT01241071

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: myofascial treatment
Description: myofascial release techniques of different muscles implicated in low back pain

Intervention type: OTHER
Group type: PLACEBO_COMPARATOR
Intervention: Placebo
Description: A manual sham intervention will be applied to different muscles implicated in low back pain
Study: NCT03726931

Intervention type: DIAGNOSTIC_TEST
Group type: EXPERIMENTAL
Intervention: 18F-Fluorestradiol PET/CT scan
Description: \[18F\]FES PET/CT scan will be performed after administration of radioactive labelled estrogen.
Study: NCT03298399

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: Autologous MSCs
Description: Participants at dose level 1 receive four infusions of MSCs, given once per week. The first MSC infusion will be given no sooner than 4 hours after the bone marrow transplant. The total number of cells delivered to each patient will depend on their weight and assigned dose level. The maximal individual dose of MSCs any patient will receive is 2 x 10\^6 cells/kg, which will be delivered via intravenous infusion. The infusion can be administered to patients in the inpatient or outpatient setting.

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: Autologous MSCs
Description: Participants at dose level 2 receive four infusions of MSCs, given twice per week. The first MSC infusion will be given no sooner than 4 hours after the bone marrow transplant. The total number of cells delivered to each patient will depend on their weight and assigned dose level. The maximal individual dose of MSCs any patient will receive is 2 x 10\^6 cells/kg, which will be delivered via intravenous infusion. The infusion can be administered to patients in the inpatient or outpatient setting.

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: Autologous MSCs
Description: Participants at dose level 3 receive six infusions of MSCs, given twice per week. The first MSC infusion will be given no sooner than 4 hours after the bone marrow transplant. The total number of cells delivered to each patient will depend on their weight and assigned dose level. The maximal individual dose of MSCs any patient will receive is 2 x 10\^6 cells/kg, which will be delivered via intravenous infusion. The infusion can be administered to patients in the inpatient or outpatient setting.
Study: NCT04809155

Intervention type: BEHAVIORAL
Group type: EXPERIMENTAL
Intervention: Girl2Girl
Description: The program has a 'core' 7 weeks of daily messages and then a week 'booster' that is delivered 3 months later.
Study: NCT01081639

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Follitropin alfa liquid formulation
Description: Follitropin alfa (Gonal-f) liquid pen (300, 450 and 900 IU) was applied by subcutaneous (sc) administration. Regimen of recombinant FSH-stimulation followed the standard protocol of the IVF-center

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Follitropin beta liquid formulation
Description: Follitropin beta (Puregon) liquid cartridge (300 and 600 IU) used with the Pen was applied by sc administration. Regimen of recombinant FSH-stimulation followed the standard protocol of the IVF-center
Study: NCT01286103

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Canagliflozin 300 mg once daily and 150 mg twice daily
Description: Treatment A (one 300-mg tablet once daily for 5 days) followed 10 days later by Treatment B (one 50-mg and one 100-mg tablet twice daily for 5 days) or Treatment B followed by Treatment A.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Canagliflozin 100 mg once daily and 50 mg twice daily
Description: Treatment C (one 100-mg tablet once daily for 5 days) followed 10 days later by Treatment D (one 50-mg tablet twice daily for 5 days) or Treatment D followed by Treatment C.
Study: NCT00784537

Intervention type: DRUG
Group type: OTHER
Intervention: ABVD
Description: ABVD courses are scheduled every 28 days:~Doxorubicin 25 mg/m2 i.v. day 1 and 15 Bleomycin 10 mg/m2 i.v. day 1 and 15 Vinblastine 6 mg/m2 i.v. day 1 and 15 Dacarbazine 375 mg/m2 i.v. day 1 and 15~ABVD courses are scheduled every 28 days:~Doxorubicin 25 mg/m2 i.v. day 1 and 15 Bleomycin 10 mg/m2 i.v. day 1 and 15 Vinblastine 6 mg/m2 i.v. day 1 and 15 Dacarbazine 375 mg/m2 i.v. day 1 and 15~Randomization to Arm A (Observation)

Intervention type: DRUG
Group type: OTHER
Intervention: ABVD and Radiotherapy
Description: ABVD courses are scheduled every 28 days:~Doxorubicin 25 mg/m2 i.v. day 1 and 15 Bleomycin 10 mg/m2 i.v. day 1 and 15 Vinblastine 6 mg/m2 i.v. day 1 and 15 Dacarbazine 375 mg/m2 i.v. day 1 and 15~Randomization to Arm B, Radiotherapy, in patients in CR, on the area of initial bulky disease (see above for the definition of nodal and/or mediastinal bulk).
Study: NCT00589316

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Fludarabine Phosphate
Description: Given IV
Study: NCT04109976

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Bimekizumab
Description: Study participants will receive bimekizumab at pre-specified time points.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Bimekizumab
Description: Study participants will receive bimekizumab at pre-specified time points.
Study: NCT00025155

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: ixabepilone
Description: Given IV
Study: NCT02073669

Intervention type: PROCEDURE
Group type: OTHER
Intervention: Answering the study Questionnaire and blood sampling for Interferon gamma release assay (IGRA)

Intervention type: PROCEDURE
Group type: OTHER
Intervention: Answering the study Questionnaire and blood sampling for Interferon gamma release assay (IGRA)
Study: NCT00589316

Intervention type: RADIATION
Group type: EXPERIMENTAL
Intervention: Iodine I 131 Monoclonal Antibody BC8
Description: Given IV (dosimetry dose) or via central line (therapeutic dose)
Study: NCT04288700

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: oral propranolol
Description: oral propranolol therapy at a dose of 1 mg/kg/d (Inderal 20 mg/5 mL) in three divided doses. If the child will tolerate the treatment with no side effects, therapy will continue in an outpatient clinic. Blood glucose level will be also measured in a periodic manner during therapy. The dose will be increased gradually to 2 mg/kg/d in three divided doses if there will be no adverse effects from the initial therapy.

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Oral Captopril
Description: A test dose of 0.1 mg kg) will be administered orally with pulse rate and blood pressure monitored at 0.5, 1 and 2 h and at each follow up. If the test dose is tolerated, captopril administration will start at 0.15 mg kg) per dose 8-hourly. Pulse rate and blood pressure will be monitored 4-hourly and doses will be withheld if hypotension is documented. After 24 h, the dose will be increased to 0.3 mg kg) per dose 8-hourly .

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: intralesional propranolol injection
Description: intralesional propranolol injection 1 mg/mL

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: topical Timolol maleate 0.5% eye drops
Description: To be Applied on the surface of the lesions three times daily
Study: NCT04547361

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: E2511
Description: E2511 tablets.
Study: NCT02337855

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: Sm-TSP-2/Alhydrogel
Description: Sm-TSP-2/Alhydrogel. Group A: single dose IM 10mcg Sm-TSP-2/Alhydrogel® on Day1, 57 and 113. Group D: single dose intramuscular (IM) 30mcg Sm-TSP-2/Alhydrogel® on Day 1, 57 and 113. Group G: single dose intramuscular (IM) 100mcg Sm-TSP-2/Alhydrogel® on Day 1, 57 and 113.

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: Sm-TSP-2/Alhydrogel
Description: Sm-TSP-2/Alhydrogel. Group A: single dose IM 10mcg Sm-TSP-2/Alhydrogel® on Day1, 57 and 113. Group D: single dose intramuscular (IM) 30mcg Sm-TSP-2/Alhydrogel® on Day 1, 57 and 113. Group G: single dose intramuscular (IM) 100mcg Sm-TSP-2/Alhydrogel® on Day 1, 57 and 113.

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: Sm-TSP-2/Alhydrogel/GLA-AF
Description: Sm-TSP-2/Alhydrogel/GLA-AF. Group B: single dose intramuscular (IM) 10mcg Sm-TSP-2/Alhydrogel®/GLA-AF on Day 1, 57 and 113. Group E: single dose intramuscular (IM) 30mcg Sm-TSP-2/Alhydrogel®/GLA-AF on Day 1, 57 and 113. Group H: single dose intramuscular (IM) 100mcg Sm-TSP-2/Alhydrogel®/GLA-AF on Day 1, 57 and 113.

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: Sm-TSP-2/Alhydrogel/GLA-AF
Description: Sm-TSP-2/Alhydrogel/GLA-AF. Group B: single dose intramuscular (IM) 10mcg Sm-TSP-2/Alhydrogel®/GLA-AF on Day 1, 57 and 113. Group E: single dose intramuscular (IM) 30mcg Sm-TSP-2/Alhydrogel®/GLA-AF on Day 1, 57 and 113. Group H: single dose intramuscular (IM) 100mcg Sm-TSP-2/Alhydrogel®/GLA-AF on Day 1, 57 and 113.
Study: NCT04547361

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: E2511
Description: E2511 tablets.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: E2511
Description: E2511 tablets.
Study: NCT00589316

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: Laboratory Biomarker Analysis
Description: Correlative studies

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Mycophenolate Mofetil
Description: Given IV or PO

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Tacrolimus
Description: Given IV or PO

Intervention type: RADIATION
Group type: EXPERIMENTAL
Intervention: Total-Body Irradiation
Description: Undergo TBI
Study: NCT04547361

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: E2511
Description: E2511 tablets.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: E2511
Description: E2511 tablets.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: E2511
Description: E2511 tablets.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: E2511
Description: E2511 tablets.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: E2511 Matched Placebo
Description: Placebo tablets matching E2511 tablets.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: E2511 Matched Placebo
Description: Placebo tablets matching E2511 tablets.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: E2511 Matched Placebo
Description: Placebo tablets matching E2511 tablets.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: E2511 Matched Placebo
Description: Placebo tablets matching E2511 tablets.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: E2511 Matched Placebo
Description: Placebo tablets matching E2511 tablets.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: E2511 Matched Placebo
Description: Placebo tablets matching E2511 tablets.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: E2511 Matched Placebo
Description: Placebo tablets matching E2511 tablets.
Study: NCT04507971

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: MET-3
Description: Human microbiome supplementation derived from bacterial strains isolated from fecal matter and grown in a laboratory environment

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: MET-3
Description: Human microbiome supplementation derived from bacterial strains isolated from fecal matter and grown in a laboratory environment
Study: NCT03704610

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Infliximab
Description: An initial period with 2 injections with infliximab allowing the determination of the primary criteria Then an extension with infliximab with 3 supplementary perfusions

Intervention type: DRUG
Group type: OTHER
Intervention: Placebo
Description: An initial period with 2 injections with placebo allowing the determination of the primary criteria Then an extension with infliximab with 5 supplementary perfusions
Study: NCT01071824

Intervention type: PROCEDURE
Group type: EXPERIMENTAL
Intervention: Transverse coloplasty pouch (Long limb)
Description: Transverse coloplasty pouch with long limb

Intervention type: PROCEDURE
Group type: ACTIVE_COMPARATOR
Intervention: Transverse coloplasty pouch (Short limb)
Description: Transverse coloplasty pouch with short limb
Study: NCT00109577

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: MCN36 (nutritional supplement)
Description: nutritional supplement

Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Placebo
Description: nutritional supplement
Study: NCT01462877

Intervention type: DRUG
Group type: OTHER
Intervention: fenofibrate
Description: Fenofibrate Capsule 200mg qd orally
Study: NCT03727412

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Drugs, Generic (Naprosyn)
Description: naproxen administration perioperatively in patients with a abdominal aortic aneurysm undergoing endovascular repair

Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Placebo Oral Tablet
Description: placebo administration perioperatively in patients with a abdominal aortic aneurysm undergoing endovascular repair
Study: NCT02029794

Intervention type: PROCEDURE
Group type: EXPERIMENTAL
Intervention: HPV self-colleciton
Description: Women will self-collect a cervical sample that will be provided to an outreach worker and then labelled and sent to laboratories in Kampala for HPV testing. Women who test positive for HPV will be contacted by phone and provided with follow-up instructions.
Study: NCT05220579

Intervention type: DEVICE
Group type: EXPERIMENTAL
Intervention: Exposure to TOR device
Description: Specific wave spectrum is directed by the TOR device to human tissues affected by the SARS-CoV-2 virus in order to disrupt its activity.

Intervention type: DEVICE
Group type: PLACEBO_COMPARATOR
Intervention: Exposure to switched off TOR device
Description: The TOR device has screened indicators on the front panel. The device was switched on / off by a medical monitor without the participation of medical personnel and investigators.
Study: NCT01541137

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Diclofenac
Description: oral diclofenac 75 mg, a 44-hour iv-infusion of diclofenac 150 mg/24h, oral diclofenac 75 mg x 2, IV-PCA programmed with morphine boluses of 2-3 mg and a lock-out time of 5-15 minutes

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: parecoxib/ valdecoxib
Description: oral valdecoxib 40 mg, a 44-hour iv-infusion of parecoxib 80 mg/24h, IV-PCA programmed with morphine boluses of 2-3 mg and a lock-out time of 5-15 minutes

Intervention type: DEVICE
Group type: ACTIVE_COMPARATOR
Intervention: patient controlled epidural analgesia
Description: epidural catheter, epidural loading dose of 1 ml/10 kg of 0.15% bupivacaine with fentanyl 6 µg/ml. Thereafter a continuous infusion was started at 1 ml/10 kg/h. In the PACU PCEA-patients could take incremental doses of 3 ml with a 8-15 min lock-out time
Study: NCT03691727

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: tirofiban hydrochloride (AGGRASTAT®)
Description: Participants will have intravenous Aggrastat administered continuously over the course of 7 days in the setting of subarachnoid hemorrhage at least 12 hours post clinically indicated Endovascular Coil Embolization procedure.

Intervention type: DIAGNOSTIC_TEST
Group type: ACTIVE_COMPARATOR
Intervention: MRI
Description: Participants will undergo 2 MRIs administered within 24 hours post Coil Embolization procedure and prior to discharge to monitor for ischemic changes.

Intervention type: DIAGNOSTIC_TEST
Group type: EXPERIMENTAL
Intervention: MRI
Description: Participants will undergo 2 MRIs administered within 24 hours post Coil Embolization procedure and prior to discharge to monitor for ischemic changes.

Intervention type: DIAGNOSTIC_TEST
Group type: ACTIVE_COMPARATOR
Intervention: Neurological Exam
Description: Neurological exams will be done at screening, randomization, days 2-7, discharge, 6 week, 6 month, and one year follow up visits.

Intervention type: DIAGNOSTIC_TEST
Group type: EXPERIMENTAL
Intervention: Neurological Exam
Description: Neurological exams will be done at screening, randomization, days 2-7, discharge, 6 week, 6 month, and one year follow up visits.

Intervention type: BEHAVIORAL
Group type: ACTIVE_COMPARATOR
Intervention: Questionnaires
Description: Quality of Life in Brain Injury - Overall Scale (QOLIBRI-OS) and the Lawton Instrumental Activities of Daily Living (IADL) will be administered at 6 month and 1 year follow up visits.
Study: NCT02029794

Intervention type: PROCEDURE
Group type: ACTIVE_COMPARATOR
Intervention: visual inspection with acetic acid (VIA)

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: 3-5% acetic acid
Study: NCT02271906

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: BIBW 2992
Description: 40 mg by mouth daily for a minimum of 14 days, and until the day of surgery.
Study: NCT02930265

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Liraglutide
Description: Liraglutide intervention group will accept liraglutide (Novo Nordisk, specifications: 18mg / 3ml; 1.8mg subcutaneous injection of 1 / day)
Study: NCT03030365

Intervention type: DEVICE
Intervention: Siemens Biograph mMR PET-MR (3T)
Description: Standardly used Magnetic resonance imaging (MRI) protocols, including resting state fMRI, task fMRI, T1 weighted imaging. In addition Patients will receive an intravenous injection of 2-5mCi of 18F-FDG prior to PET MRI.

Intervention type: DEVICE
Intervention: Siemens Biograph mMR PET-MR (3T)
Description: Standardly used Magnetic resonance imaging (MRI) protocols, including resting state fMRI, task fMRI, T1 weighted imaging. In addition Patients will receive an intravenous injection of 2-5mCi of 18F-FDG prior to PET MRI.

Intervention type: DEVICE
Intervention: Siemens Biograph mMR PET-MR (3T)
Description: Standardly used Magnetic resonance imaging (MRI) protocols, including resting state fMRI, task fMRI, T1 weighted imaging. In addition Patients will receive an intravenous injection of 2-5mCi of 18F-FDG prior to PET MRI.
Study: NCT02192632

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Epiduo once daily with detailed instruction for how to apply it
Study: NCT03691727

Intervention type: BEHAVIORAL
Group type: EXPERIMENTAL
Intervention: Questionnaires
Description: Quality of Life in Brain Injury - Overall Scale (QOLIBRI-OS) and the Lawton Instrumental Activities of Daily Living (IADL) will be administered at 6 month and 1 year follow up visits.

Intervention type: DIAGNOSTIC_TEST
Group type: ACTIVE_COMPARATOR
Intervention: Vital Signs
Description: Vital signs which include temperature, respiration rate, blood pressure and O2 stats will be done at screening, randomization, days 2-7, discharge, 6 week, 6 month, and one year follow up visits.

Intervention type: DIAGNOSTIC_TEST
Group type: EXPERIMENTAL
Intervention: Vital Signs
Description: Vital signs which include temperature, respiration rate, blood pressure and O2 stats will be done at screening, randomization, days 2-7, discharge, 6 week, 6 month, and one year follow up visits.

Intervention type: OTHER
Group type: ACTIVE_COMPARATOR
Intervention: Standard of Care Treatment
Description: Participants will receive standard of care treatment and will not receive study drug.
Study: NCT03327948

Intervention type: DEVICE
Group type: EXPERIMENTAL
Intervention: Axonics Sacral Neuromodulation System (SNM) System
Description: Axonics Sacral Neuromodulation System (SNM) System
Study: NCT01080183

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: Patient feedback form
Description: patients receive a report that feeds back their patient reported measures to them prior to their clinical visit
Study: NCT03906422

Intervention type: DEVICE
Group type: EXPERIMENTAL
Intervention: 3M Unitek 0.016 orthodontic archwire
Description: Placement of 3M Unitek 0.016 archwire for orthodontic treatment

Intervention type: DEVICE
Group type: EXPERIMENTAL
Intervention: Device: 0.016 Ormco 27oC NiTi orthodontic archwire
Description: Placement of 0.016 Ormco 27oC NiTi orthodontic archwire

Intervention type: DEVICE
Group type: EXPERIMENTAL
Intervention: Device: 0.016 Ormco 35oC NiTi orthodontic archwire
Description: Placement of 0.016 Ormco 35oC NiTi orthodontic archwire