TrialPanorama/TrialPanorama-database huggingface dataset:
Study: NCT03704831

Intervention type: OTHER
Intervention: Injection of local anesthetics during total knee arthroplasty by a locoregional anesthesia named IPACK block
Description: Injection of local anesthetics during total knee arthroplasty by a locoregional anesthesia named IPACK block (Interspace between the Popliteal Artery and the Capsule of the posterior Knee)

Intervention type: OTHER
Intervention: Injection of local anesthetics during total knee arthroplasty by surgical infiltration
Description: Injection of local anesthetics during total knee arthroplasty by surgical infiltration.
Study: NCT03665662

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: Music
Description: Intra-procedure music through headphones
Study: NCT02732392

Intervention type: PROCEDURE
Group type: EXPERIMENTAL
Intervention: standard lymphadenectomy

Intervention type: PROCEDURE
Group type: EXPERIMENTAL
Intervention: lymphadenectomy radio-isotope method
Study: NCT02932800

Intervention type: PROCEDURE
Group type: ACTIVE_COMPARATOR
Intervention: Fixation with ballerina technique and flip

Intervention type: PROCEDURE
Group type: ACTIVE_COMPARATOR
Intervention: Habitual Fixation
Description: Evaluation on the third and fift days, filogisticos and infectious signs, fixing loss, and culture

Intervention type: OTHER
Group type: ACTIVE_COMPARATOR
Intervention: Evaluation on the third and fift days, filogisticos and infectious signs, fixing loss, and culture

Intervention type: OTHER
Group type: ACTIVE_COMPARATOR
Intervention: Evaluation on the third and fift days, filogisticos and infectious signs, fixing loss, and culture
Study: NCT02764476

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: Embodied Virtual Reality Therapy
Description: Participants will be asked to play a game in Stanford's Virtual Reality Human Interaction Lab that engages visual pathways and involves body tracking and controlled sensory feedback reinforcing movement in real and virtual time by immersive head mounted displays. This game will have subjects fully embody and inhabit an avatar from an egocentric perspective. In addition, over consecutive sessions subjects will be asked to use a mobile smart phone based virtual reality program designed to deliver various and customized emotionally provocative stimuli.

Intervention type: OTHER
Group type: ACTIVE_COMPARATOR
Intervention: Virtual reality
Description: Participants will be asked to play a game in Stanford's Virtual Reality Human Interaction Lab that engages visual pathways.
Study: NCT03126786

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: IVT aflibercept
Description: IVT aflibercept \[2 mg/0.05 mL\]

Intervention type: DRUG
Group type: SHAM_COMPARATOR
Intervention: IVT aflibercept
Description: IVT aflibercept \[2 mg/0.05 mL\]

Intervention type: DRUG
Group type: SHAM_COMPARATOR
Intervention: Sham SC
Description: sham SC

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: SC CLS-TA
Description: CLS-TA \[4 mg/100 μL\] SC injection
Study: NCT02903810

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: Mixed CAR-T Transfer
Description: All subjects will be infused with αCD19-TCRz-41BB and αCD22-TCRz-41BB CAR-T cells in equal number
Study: NCT01601496

Intervention type: DEVICE
Group type: EXPERIMENTAL
Intervention: FUSION Vascular Graft
Description: All subjects who received the FUSION Vascular Graft at the baseline implant procedure.
Study: NCT04680247

Intervention type: PROCEDURE
Group type: ACTIVE_COMPARATOR
Intervention: VA-LCP
Description: Surgery using the VA-LCP implant

Intervention type: PROCEDURE
Group type: ACTIVE_COMPARATOR
Intervention: NCB-PT
Description: Surgery using the NCB-PT implant
Study: NCT03489980

Intervention type: OTHER
Intervention: coloring-type artistic task of a complex form
Description: coloring-type artistic task of a complex form

Intervention type: OTHER
Intervention: coloring-type artistic task of a complex form
Description: coloring-type artistic task of a complex form

Intervention type: OTHER
Intervention: coloring-type artistic task of a complex form
Description: coloring-type artistic task of a complex form
Study: NCT01439984

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Clomipramine
Description: Clomipramine 15 mg tablet or placebo tablet on demand for 12 weeks

Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Clomipramine
Description: Clomipramine 15 mg tablet or placebo tablet on demand for 12 weeks
Study: NCT04649086

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: Rehabilitation by Eccentric exercises
Description: Participants will perform 24 exercises sessions (30 minutes) with cycloergometer in eccentric mode (while resisting against self-paced pedaling), inducing a greater muscular hypertrophy as compared with concentric mode, the mechanical stimulation being 3 to 4 times greater at the same level metabolic stimulation.

Intervention type: OTHER
Group type: ACTIVE_COMPARATOR
Intervention: Rehabilitation by Concentric exercises
Description: The control group (concentric) will perform exercise training at an intensity of 60% of the reserve heart rate determined during an initial cardiorespiratory test. The power will be adjusted weekly to stay within the target heart rate range.
Study: NCT03138577

Intervention type: DIAGNOSTIC_TEST
Group type: OTHER
Intervention: Ultrasound Imaging
Description: M-mode tracings of right diaphragm motion will be made and recorded by a skilled anesthesiologist. Patients will be examined in the supine position and scanned from a low intercostal or subcostal approach using the liver as an acoustic window. Patients will be asked to perform a voluntary sniff (VS) test, for which they will be asked to forcefully inhale through the nose in a sniffing position. The above measurement will be performed immediately preceding the brachial plexus blockade, and then at 15 minute and 30 minutes after block.

Intervention type: DIAGNOSTIC_TEST
Group type: OTHER
Intervention: Ultrasound Imaging
Description: M-mode tracings of right diaphragm motion will be made and recorded by a skilled anesthesiologist. Patients will be examined in the supine position and scanned from a low intercostal or subcostal approach using the liver as an acoustic window. Patients will be asked to perform a voluntary sniff (VS) test, for which they will be asked to forcefully inhale through the nose in a sniffing position. The above measurement will be performed immediately preceding the brachial plexus blockade, and then at 15 minute and 30 minutes after block.
Study: NCT03070886

Intervention type: RADIATION
Group type: ACTIVE_COMPARATOR
Intervention: External Beam Radiation Therapy
Description: Undergo external beam radiation therapy

Intervention type: RADIATION
Group type: EXPERIMENTAL
Intervention: External Beam Radiation Therapy
Description: Undergo external beam radiation therapy
Study: NCT01155622

Intervention type: PROCEDURE
Group type: ACTIVE_COMPARATOR
Intervention: Endovascular Cooling
Description: Infusion of \<8°C cold saline followed by the implantation of the Icy 9.3F 38-cm catheter (ZOLL Medical Corporation, Chelmsford, MA) placed in the inferior vena cava through a femoral vein connected to the Thermogard XP Temperature Management System (ZOLL Medical Corporation). Cooling was set at a maximum rate with a target temperature of 32°C or 34°C according to randomization.

Intervention type: PROCEDURE
Group type: ACTIVE_COMPARATOR
Intervention: Endovascular Cooling
Description: Infusion of \<8°C cold saline followed by the implantation of the Icy 9.3F 38-cm catheter (ZOLL Medical Corporation, Chelmsford, MA) placed in the inferior vena cava through a femoral vein connected to the Thermogard XP Temperature Management System (ZOLL Medical Corporation). Cooling was set at a maximum rate with a target temperature of 32°C or 34°C according to randomization.
Study: NCT02504320

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Febuxostat XR 80 mg Capsule F1
Description: Febuxostat extended-release (XR) capsules formulation 1

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Febuxostat XR 80 mg Capsule F1
Description: Febuxostat extended-release (XR) capsules formulation 1

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Febuxostat XR 80 mg Capsule F1
Description: Febuxostat extended-release (XR) capsules formulation 1

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Febuxostat XR 80 mg Capsule F1
Description: Febuxostat extended-release (XR) capsules formulation 1

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Febuxostat XR 80 mg Capsule F2
Description: Febuxostat XR capsules formulation 2

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Febuxostat XR 80 mg Capsule F2
Description: Febuxostat XR capsules formulation 2

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Febuxostat XR 80 mg Capsule F2
Description: Febuxostat XR capsules formulation 2

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Febuxostat XR 80 mg Capsule F2
Description: Febuxostat XR capsules formulation 2

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Febuxostat XR 80 mg Capsule F3
Description: Febuxostat XR capsules formulation 3

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Febuxostat XR 80 mg Capsule F3
Description: Febuxostat XR capsules formulation 3

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Febuxostat XR 80 mg Capsule F3
Description: Febuxostat XR capsules formulation 3

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Febuxostat XR 80 mg Capsule F3
Description: Febuxostat XR capsules formulation 3

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Febuxostat XR 80 mg Capsule F4
Description: Febuxostat XR capsules formulation 4

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Febuxostat XR 80 mg Capsule F4
Description: Febuxostat XR capsules formulation 4

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Febuxostat XR 80 mg Capsule F4
Description: Febuxostat XR capsules formulation 4
Study: NCT03070886

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Flutamide
Description: Given PO

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Flutamide
Description: Given PO

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Goserelin
Description: Given IM

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Goserelin
Description: Given IM

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Goserelin Acetate
Description: Given IM

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Goserelin Acetate
Description: Given IM

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

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

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Leuprolide
Description: Given intramuscularly (IM)

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Leuprolide
Description: Given intramuscularly (IM)

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Leuprolide Acetate
Description: Given IM

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Leuprolide Acetate
Description: Given IM

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Nilutamide
Description: Given PO

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Nilutamide
Description: Given PO
Study: NCT03602157

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: ATLCAR.CD30.CCR4 cells
Description: Three dose levels are being evaluated: 2x10\^7, 5x10\^7, 1x10\^8

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: ALTCAR.CD30 cells
Description: Fixed dose level of 1x10\^8

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Bendamustine
Description: 70 mg/m\^2/day Bendamustine for 3 days for lymphodepletion prior to cell infusion

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Fludarabine
Description: 30 mg/m\^2/day Fludarabine for 3 days for lymphodepletion prior to cell infusion
Study: NCT02504320

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Febuxostat XR 80 mg Capsule F4
Description: Febuxostat XR capsules formulation 4
Study: NCT00905424

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Antidepressant + SPD489 (lisdexamfetamine dimesylate)
Description: Escitalopram oxalate (antidepressant) 20 mg/day oral + 20, 30, or 50 mg SPD489 oral once daily for 6 weeks

Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Antidepressant + placebo
Description: Escitalopram oxalate (antidepressant) 20 mg/day oral + placebo oral once daily for 6 weeks
Study: NCT02546128

Intervention type: DEVICE
Group type: EXPERIMENTAL
Intervention: Extra-Corporeal Shockwave Therapy (ESWT)
Description: The use of ESWT from a commercially available machine at approved settings already in routine clinical use

Intervention type: OTHER
Group type: PLACEBO_COMPARATOR
Intervention: structured rehabilitation programme
Description: a structured and standardised rehabilitation programme specific to the tendon in question - already in routine clinical use

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: structured rehabilitation programme
Description: a structured and standardised rehabilitation programme specific to the tendon in question - already in routine clinical use
Study: NCT01681953

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Lamazym
Description: ERT, i.v. infusions weekly

Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Placebo
Description: Infusions weekly
Study: NCT03126461

Intervention type: RADIATION
Group type: EXPERIMENTAL
Intervention: SAbR
Description: For patients treated on the GRID A regimen, a dose of 15-20 Gy will be delivered with the GRID device in either a single field, with prescription to dmax, or with parallel opposed GRID fields (matching beamlets from the opposed directions). For patients treated on the GRID B regimen, this same dose will be delivered, with a subsequent regimen of 3 Gy X 10 fractions, with the first of these fractions following the GRID dose.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Ipilimumab
Description: ipilimumab 3mg/kg IV q3wk x 4

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Nivolumab
Description: nivolumab 1 mg/kg IV q3wk x 4
Study: NCT00438204

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: bevacizumab
Description: Bevacizumab 10mg/kg IV over 90 ± 15 minutes every 14 days

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: gemcitabine hydrochloride
Description: Gemcitabine 1200 mg/m2 intravenously over 30 minutes following the pemetrexed every 14 days

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: pemetrexed disodium
Description: Pemetrexed disodium 400 mg/m2 intravenously over 10 minutes every 14 days.
Study: NCT02306850

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Pembrolizumab
Description: At the Treatment Initiation Visit (Baseline/Day 1), subjects will begin treatment with IV pembrolizumab 200 mg infusions every 3 weeks. As in previous pembrolizumab trials, eligible subjects will receive at least 24 weeks of therapy and may receive up to 2 years of pembrolizumab therapy depending on response to treatment.
Study: NCT06190600

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: High Intensity Interval Training (HIIT)
Description: HIIT training twice a week throughout the chemotherapy: treadmill, elliptical, stationary bicycle and indoor rower. The intensity of physical activity will be increasing during consecutive mesocycles. Each training session will begin with a 10-min. wole-body warm-up session at 50-60% hear rate (HR) max. Mesocycle 1 - one month with 4 sets of 1 min. 45 sec. of exercise at a maximal intensity of 75% HR max. Mesocycle 2 with exercises at 80% to 90% HR max divided into 3 periods: 1/ one month, session of 5 sets 1 min. 30 sec. each; 2/ two months, sessions of 5 sets 1 min. 45 sec. each; 3/ two months, sessions of 5 sets 2 min. each. Moreover patients will be instructed to individually perform- a 45-min. aerobic training session (e.g.: walking, jogging, roller skating, swimming) once a week, in patient's own time.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: neoadjuvant treatment (doxorubicin, cyclophosphamide, paclitaxel, trastuzumab, pertuzumab)
Description: Patients aged 18 to 40 in good physical condition (Eastern Cooperative Oncology Group (ECOG) scale 0-1) who are set to receive neoadjuvant chemotherapy will be selected. Criteria for entry into the study include proper liver, kidney and bone marrow function as well as heart ejection fraction of ≥ 50%. Treatment will be carried out according to 4 x AC regimen (doxorubicin 60 mg/ m2 cyclophosphamide 600 mg/ m2 i.v. every 21 or every 14 days + pegfilgastrim) followed by 12 x paclitaxel 80 mg/ m2 every 7 days and in the case of HER2 positive tumors trastuzumab ± pertuzumab (according to SPC).

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: neoadjuvant treatment (doxorubicin, cyclophosphamide, paclitaxel, trastuzumab, pertuzumab)
Description: Patients aged 18 to 40 in good physical condition (Eastern Cooperative Oncology Group (ECOG) scale 0-1) who are set to receive neoadjuvant chemotherapy will be selected. Criteria for entry into the study include proper liver, kidney and bone marrow function as well as heart ejection fraction of ≥ 50%. Treatment will be carried out according to 4 x AC regimen (doxorubicin 60 mg/ m2 cyclophosphamide 600 mg/ m2 i.v. every 21 or every 14 days + pegfilgastrim) followed by 12 x paclitaxel 80 mg/ m2 every 7 days and in the case of HER2 positive tumors trastuzumab ± pertuzumab (according to SPC).

Intervention type: OTHER
Group type: ACTIVE_COMPARATOR
Intervention: Standard Supportive Care
Description: Patients will be asked to perform 150-300 min. of moderate-intensity aerobic activity or 75-150 min. of vigorous aerobic activity. Each participant will be monitored by an activity watch worn at all times by the patient.
Study: NCT01922258

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Brexpiprazole, OPC-34712
Description: Flexible dose of 0.5 to 2 mg/day or placebo tablets for up to 12 weeks

Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Brexpiprazole, OPC-34712
Description: Flexible dose of 0.5 to 2 mg/day or placebo tablets for up to 12 weeks
Study: NCT02506699

Intervention type: OTHER
Intervention: analgesic effect of rTMS
Study: NCT01007604

Intervention type: DEVICE
Group type: EXPERIMENTAL
Intervention: Peristaltic pulse PCD
Description: Daily use for two hours

Intervention type: OTHER
Group type: ACTIVE_COMPARATOR
Intervention: Exercise and lifestyle counseling
Description: Patients will receive standard recommendations for ambulatory exercise and standard educational discussion of risk factor control, including smoking cessation.
Study: NCT02820519

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Loxapine
Description: Loxapine dose escalation according to tolerability and analgesic efficacy
Study: NCT02472886

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: LDV/SOF
Description: 90/400 mg FDC tablet administered orally once daily
Study: NCT00539591

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Peginterferon alfa-2b
Description: Given either IV or SQ. Therapeutic drug class: interferon.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Peginterferon alfa-2b
Description: Given either IV or SQ. Therapeutic drug class: interferon.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Temozolomide
Description: Given PO. Therapeutic drug class: antineoplastic agent.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Temozolomide
Description: Given PO. Therapeutic drug class: antineoplastic agent.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Recombinant interferon alfa-2b
Description: Given IV. Therapeutic drug classes: antineoplastic agent, immunomodulatory agent, interferon
Study: NCT03924635

Intervention type: COMBINATION_PRODUCT
Group type: ACTIVE_COMPARATOR
Intervention: SYMBICORT and salbutamol
Description: SYMBICORT will be given in a TURBOHALER. Salbutamol will be given in a pressurised metered dose inhaler.

Intervention type: COMBINATION_PRODUCT
Group type: ACTIVE_COMPARATOR
Intervention: SYMBICORT and salbutamol
Description: SYMBICORT will be given in a TURBOHALER. Salbutamol will be given in a pressurised metered dose inhaler.
Study: NCT02472886

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: LDV/SOF
Description: 90/400 mg FDC tablet administered orally once daily

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: LDV/SOF
Description: 90/400 mg FDC tablet administered orally once daily

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: RBV
Description: Tablets administered orally in a divided daily dose according to package insert weight-based dosing recommendations (\< 75 kg = 1000 mg and ≥ 75 kg = 1200 mg)
Study: NCT00770913

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: E3810
Description: 20 mg taken orally, once a day for 8 weeks.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: E3810
Description: 10 mg, taken orally, twice a day for 8 weeks.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: E3810
Description: 20 mg taken orally, twice a day for 8 weeks.
Study: NCT00382785

Intervention type: BEHAVIORAL
Group type: EXPERIMENTAL
Intervention: moderated support
Description: one 12-week online support group led by a professional healthcare provider

Intervention type: BEHAVIORAL
Group type: EXPERIMENTAL
Intervention: peer-led
Description: 12-week online support in a peer-led format
Study: NCT01074177

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: BIBW 2992
Description: Taken orally once a day
Study: NCT03180268

Intervention type: OTHER
Group type: OTHER
Intervention: Clinical Observation
Description: Undergo observation

Intervention type: RADIATION
Group type: EXPERIMENTAL
Intervention: Radiation Therapy
Description: Undergo radiation therapy
Study: NCT04097145

Intervention type: DEVICE
Group type: EXPERIMENTAL
Intervention: Edwards PASCAL System
Description: Transcatheter tricuspid valve repair with the Edwards PASCAL System in patients on optimal medical therapy

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Optimal Medical Therapy
Description: Optimal Medical Therapy alone in patients with tricuspid regurgitation

Intervention type: DEVICE
Group type: EXPERIMENTAL
Intervention: Edwards PASCAL System
Description: Transcatheter tricuspid valve repair with the Edwards PASCAL System in conjunction with OMT

Intervention type: DEVICE
Group type: EXPERIMENTAL
Intervention: Edwards PASCAL System
Description: Transcatheter tricuspid valve repair with the Edwards PASCAL system in patients on optimal medical therapy (OMT) with tricuspid regurgitation