AIM-Harvard/TrialPanorama-filtered huggingface dataset:
Study NCT04821843 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Nimotuzumab
Description: 200-400mg, d1,qW
Study NCT00617448 — intervention group
Intervention type: PROCEDURE
Group type: ACTIVE_COMPARATOR
Intervention: Ligasure haemorrhoidectomy under local anesthesia
Description: For surgery: haemorrhoidectomy with Ligasure For anesthesia: pudendal nerve block, infiltration of the right and left pararectal spaces, anterior and presacral regions with ropivacaine (150 mg of ropivacaine \[20 mL, 7.5 mg/mL\] diluted in 50 mL of 0.9% physiological saline). Ten minutes before local anaesthesia, patients were sedated with i.v. remifentanil 0.05-0.15 μg·kg-1
Study NCT01904500 — intervention group
Intervention type: DRUG
Group type: OTHER
Intervention: Pre-operative cefazolin
Study NCT01904500 — intervention group
Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Pre-operative cefazolin
Study NCT02114697 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Statin therapy
Description: Statin therapy includes rosuvastatin 20 mg administered orally, once a day, for the duration of the trial, which is 3 years. Participants may also receive a different type of statin as prescribed by their cardiologist based on clinical judgement.
Study NCT02114697 — intervention group
Intervention type: BEHAVIORAL
Group type: ACTIVE_COMPARATOR
Intervention: Lifestyle modification
Description: Lifestyle modification includes a recommended exercise regimen, a healthy diet and decreasing alcohol intake for 3 years.
Study NCT01986036 — intervention group
Intervention type: DIETARY_SUPPLEMENT
Group type: EXPERIMENTAL
Intervention: Protein
Description: Milk-Protein
Study NCT01986036 — intervention group
Intervention type: DIETARY_SUPPLEMENT
Group type: ACTIVE_COMPARATOR
Intervention: Protein
Description: Milk-Protein
Study NCT01986036 — intervention group
Intervention type: DIETARY_SUPPLEMENT
Group type: ACTIVE_COMPARATOR
Intervention: Calcium
Description: Soluble calcium powder.
Study NCT01986036 — intervention group
Intervention type: DIETARY_SUPPLEMENT
Group type: EXPERIMENTAL
Intervention: Calcium
Description: Soluble calcium powder.
Study NCT01986036 — intervention group
Intervention type: DIETARY_SUPPLEMENT
Group type: ACTIVE_COMPARATOR
Intervention: Porridge-based breakfast.
Description: Oats and water.
Study NCT01986036 — intervention group
Intervention type: DIETARY_SUPPLEMENT
Group type: SHAM_COMPARATOR
Intervention: Porridge-based breakfast.
Description: Oats and water.
Study NCT01986036 — intervention group
Intervention type: DIETARY_SUPPLEMENT
Group type: EXPERIMENTAL
Intervention: Porridge-based breakfast.
Description: Oats and water.
Study NCT01521559 — intervention group
Intervention type: PROCEDURE
Group type: SHAM_COMPARATOR
Intervention: Macular Laser Photocoagulation
Study NCT01521559 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321)
Study NCT04491409 — intervention group
Intervention type: OTHER
Intervention: Best Practice
Description: Undergo standard of care
Study NCT04491409 — intervention group
Intervention type: OTHER
Intervention: Medical Chart Review
Description: Medical charts reviewed
Study NCT02942966 — intervention group
Intervention type: DEVICE
Group type: EXPERIMENTAL
Intervention: Tack Endovascular System
Description: Repair of post-PTA dissections using the Intact Vascular Tack Endovascular System.
Study NCT02974153 — intervention group
Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: ALD403 (Eptinezumab)
Study NCT02974153 — intervention group
Intervention type: BIOLOGICAL
Group type: PLACEBO_COMPARATOR
Intervention: Placebo
Study NCT02337465 — intervention group
Intervention type: DEVICE
Group type: EXPERIMENTAL
Intervention: Cone-Beam Computed Tomography
Description: Undergo kilo-voltage cone beam computed tomography
Study NCT02337465 — intervention group
Intervention type: RADIATION
Group type: EXPERIMENTAL
Intervention: 3-Dimensional Ultrasound-Guided Radiation Therapy
Description: Undergo ultrasound-guided radiation therapy
Study NCT04544371 — intervention group
Intervention type: DEVICE
Intervention: gastric ultrasound
Description: Focused gastric ultrasound was performed in semi-sitting position then right lateral position mindray curved transducer for examination of abdomen with low frequency (2-5 MHz) by a trained physician. The antrum of the stomach was located in the epigastrium after a sweep of the probe from left to right subcostal margins. This could be done using left lobe of liver as an anterior landmark and descending abdominal aorta as a posterior landmark
Study NCT04544371 — intervention group
Intervention type: PROCEDURE
Intervention: nasogastric tube insertion
Description: Nasogastric tube (18-french) was inserted after induction of anaesthesia and endotracheal intubation. Aspiration of gastric contents was performed through gentle suction using 50 ml syringe with synchronous epigastric massage and gentle movement of nasogastric tube in and out for 10 minutes after confirmation of nasogastric tube position.
Study NCT05802966 — intervention group
Intervention type: BEHAVIORAL
Intervention: Mindfulness-Based Cognitive Therapy
Description: MBCT will be offered according to the MBCT manual developed for relapse prevention in MDD (Zindel V. Segal, Williams, \& Teasdale, 2002). Thus, MBCT will consist of 8-weekly sessions of 2,5 hours, a 6-hour silent day, and daily home practice (± 45min). MBCT will be taught by a certified MBCT teacher meeting the advanced criteria of the Association of Mindfulness Based Teachers in the Netherlands and Flanders (Belgium) which are in concordance with the Good Practice guidelines of the UK Network of Mindfulness-Based Teacher Trainers (Crane et al., 2012).
Study NCT01065103 — intervention group
Intervention type: PROCEDURE
Group type: EXPERIMENTAL
Intervention: FFR (Fractional Flow Reserve)
Description: Single FFR measurement in non-culprit vessel
Study NCT01335477 — intervention group
Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: placebo
Description: placebo matching BIBF 1120 BID
Study NCT01335477 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: BIBF 1120
Description: BIBF 1120 BID (twice daily)
Study NCT00002965 — intervention group
Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: Recombinant Interferon Alfa (INF alpha)
Description: Subcutaneous injection Monday through Friday for 8 weeks.
Study NCT00890019 — intervention group
Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: AdCh63 ME-TRAP
Description: 1. A:Intradermal injection 1x10\^8 vp at day 0~2. A:Intradermal injection 1x10\^9 vp at day 0~3. A:Intradermal injection 1x10\^10 vp at day 0~4. A:Intradermal injection 5x10\^10 vp at day 0~5:Intramuscular injection 1x10\^10 vp at day 0~6A:Intramuscular injection 5x10\^10 vp at day 0~7A: Intramuscular injection 2x10\^11 vp at day 0
Study NCT00890019 — intervention group
Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: AdCh63 ME-TRAP; MVA ME-TRAP
Description: 1. B: AdCh63 ME-TRAP intradermally at dose of 1x10\^8 vp at day 0; MVA ME-TRAP intradermally at dose of 2x10\^8 pfu at day 56 (+/- 7 days)~2. B: AdCh63 ME-TRAP intradermally at dose of 1x10\^9 vp at day 0; MVA ME-TRAP intradermally at dose of 2x10\^8 pfu at day 56 (+/- 7 days)~3. B: AdCh63 ME-TRAP intradermally at dose of 1x10\^10 vp at day 0; MVA ME-TRAP intradermally at dose of 2x10\^8 pfu at day 56 (+/- 7 days)~4. B: AdCh63 ME-TRAP intradermally at dose of 5x10\^10 vp at day 0; MVA ME-TRAP intradermally at dose of 2x10\^8 pfu at day 56 (+/- 7 days)~6B: AdCh63 ME-TRAP intramuscularly at dose of 5x10\^10 vp at day 0; MVA ME-TRAP intradermally at dose of 2x10\^8 pfu at day 56 (+/- 7 days)~7B and 7C: AdCh63 ME-TRAP intramuscularly at dose of 2x10\^11 vp at day 0; MVA ME-TRAP intradermally at dose of 2x10\^8 pfu at day 56 (+/- 7 days)
Study NCT00682084 — intervention group
Intervention type: PROCEDURE
Intervention: Surgery
Description: Surgical removal of either a pituitary or ectopic ACTH producing tumor or an adrenal tumor
Study NCT03401710 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Erythropoietin
Description: Erythropoietin 4000 UI will be administered every other day subcutaneously
Study NCT00602030 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Entinostat
Description: Entinostat tablets on Days 1 and 15 of a 28-day cycle.
Study NCT00602030 — intervention group
Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Placebo
Description: Placebo-matching entinostat tablets on Days 1 and 15 of a 28-day cycle.
Study NCT00602030 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Erlotinib
Description: Erlotinib 150 mg tablets once daily.
Study NCT00602030 — intervention group
Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Erlotinib
Description: Erlotinib 150 mg tablets once daily.
Study NCT02678195 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Amoxicillin
Description: Oral amoxicillin dispersible tablets (DT), 250 mg tablets, given according to age band, two times daily
Study NCT02678195 — intervention group
Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Amoxicillin
Description: Oral amoxicillin dispersible tablets (DT), 250 mg tablets, given according to age band, two times daily
Study NCT02678195 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Placebo
Description: Placebo dispersible tablets (DT), 250 mg tablets, given according to age band, two times daily
Study NCT03019965 — intervention group
Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Intermittent Piperacillin/tazobactam
Description: Piperacillin/tazobactam administered in 30 minutes infusion.
Study NCT03019965 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Continuous Piperacillin/tazobactam
Description: Piperacillin/tazobactam administered in 24 hours infusion.
Study NCT03019965 — intervention group
Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Intermittent Imipenem
Description: Imipenem administered in 60 minutes infusion.
Study NCT03019965 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Extended Imipenem
Description: Imipenem administered in 6 hours infusion.
Study NCT03019965 — intervention group
Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Intermittent Meropenem
Description: Meropenem administered in 60 minutes infusion.
Study NCT03019965 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Extended Meropenem
Description: Meropenem administered in 8 hours infusion.
Study NCT04154709 — intervention group
Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: CTA101
Description: Universal CD19-directed CAR-T cells by a single infusion intravenously will be given in escalating doses.
Study NCT00692653 — intervention group
Intervention type: BEHAVIORAL
Group type: EXPERIMENTAL
Intervention: P4
Description: Tailored online decision support system for prostate cancer treatment decision making
Study NCT02879721 — intervention group
Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Candesartan
Description: Angiotensin II, type 1 receptor inhibitor, (candesartan) 8 mg once daily for
Study NCT02879721 — intervention group
Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Enalapril
Description: Angiotensin-converting enzyme (ACE) inhibitor (enalapril) 5 mg once daily
Study NCT01609764 — intervention group
Intervention type: BEHAVIORAL
Group type: EXPERIMENTAL
Intervention: One year fitness training
Description: Regular training schedule of moderate intensity, at 50% of heart rate reserve, as available for the specific age group in fitness centres
Study NCT01241461 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: LY2584702
Description: Dose escalation starting at 50 milligram (mg). On Day 1, subjects will receive a single oral dose. After a two-day observation period, subjects will receive oral doses twice daily for a 28-day cycle.~Patients may continue 28-day cycles of twice daily dosing until discontinuation criteria are met.
Study NCT00719290 — intervention group
Intervention type: PROCEDURE
Group type: ACTIVE_COMPARATOR
Intervention: Phacoemulsification (Acrylic Foldable Intraocular Lens (Acrysoft)), (Healon5)
Description: Phacoemulsification of the lens with intraocular lens implant
Study NCT00719290 — intervention group
Intervention type: PROCEDURE
Group type: ACTIVE_COMPARATOR
Intervention: Phacoemulsification and goniosynechialysis (Acrylic Foldable Intraocular Lens (Acrysoft)), (Healon5)
Description: Phacoemulsification of the lens with intraocular lens implant and goniosynechialysis
Study NCT02763722 — intervention group
Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: Emollient spray product
Description: All patients will be instructed to use emollients spray on entire skin at least twice a day for four weeks.
Study NCT01531205 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Androgen Ablation
Description: All patients will receive luteinizing hormone-releasing hormone (LHRH) agonist therapy (leuprolide or goserelin acetate) concurrent with Cabazitaxel, before surgery. A course of bicalutamide 50 mg daily orally for 14-21 days is recommended for patients starting LHRH agonist therapy and suspected to be at risk for tumor flare, e.g., significant obstructive urinary symptoms and will be optional in other patients.
Study NCT01531205 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Cabazitaxel
Description: Intravenous treatment with Cabazitaxel 25 mg/m\^2 is given on day 1 every 21 days. A cycle of chemotherapy will be defined as 21 days. A total of four cycles of combination therapy are planned for a total duration of 12 weeks (before surgery), starting within 3 weeks of protocol entry, to be given concurrent with hormone therapy.
Study NCT01531205 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Salvage Therapy
Description: Patients will undergo 4 cycles of chemotherapy in conjunction with LHRH agonist therapy (before surgery) subsequent to which they will have their serum Prostate-specific antigen (PSA), bone scan, abdominal pelvic computed tomography (CT) or magnetic resonance imaging (MRI) repeated. Patients with a detectable metastatic diseases will be removed from the study. Salvage surgery will be performed within 8 weeks after the completion of Cabazitaxel chemotherapy. For patients who achieved undetectable PSA following surgery, androgen deprivation therapy will be discontinued.
Study NCT01531205 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Neoadjuvant Treatment - Hormonal Therapy
Description: All treatment will be given on an outpatient basis. Treatment should start within 3 weeks of protocol entry. All patients will receive androgen ablation with LHRH agonist therapy in conjunction with the 4 cycles of Cabazitaxel for neoadjuvant chemohormonal therapy. Androgen ablative therapy will be discontinued before surgery. A course of bicalutamide 50 mg daily orally for 14-21 days is recommended for patients starting LHRH agonist therapy and suspected to be at risk for tumor flare, e.g., significant obstructive urinary symptoms and will be optional in other patients.
Study NCT01531205 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Neoadjuvant Treatment - Cabazitaxel
Description: All treatment will be given on an outpatient basis and should start within 3 weeks of protocol entry. Intravenous treatment with Cabazitaxel is given on Day 1 every 3 weeks. A cycle of combination therapy will be defined as 3 weeks. A total of 4 cycles of combination therapy are planned before surgery for a total duration of 12 weeks.~Cabazitaxel will be administered before surgery by one-hourly infusions via central or peripheral intravenous access at a dose of 25 mg/m\^2 as a one hour intravenous infusion in combination with oral prednisone 10 mg administered daily throughout Cabazitaxel treatment. It is advised that all patients receiving Cabazitaxel have a reliable form of venous access, e.g., central venous catheter to ensure their ability to receive therapy without undue delay.
Study NCT06123507 — intervention group
Intervention type: BEHAVIORAL
Group type: EXPERIMENTAL
Intervention: Student practitioner perspective-taking intervention
Description: This intervention compares the outcomes where some learn about and practice perspective-taking and others do not. All participants received at least a partial intervention through getting video-feedback on their dialogue with a client actor.
Study NCT06123507 — intervention group
Intervention type: BEHAVIORAL
Group type: ACTIVE_COMPARATOR
Intervention: Student practitioner perspective-taking intervention
Description: This intervention compares the outcomes where some learn about and practice perspective-taking and others do not. All participants received at least a partial intervention through getting video-feedback on their dialogue with a client actor.
Study NCT02082171 — intervention group
Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: Multidomain intervention
Description: Multidomain preventive intervention designed by a multidisciplinary team on the basis of results of a comprehensive geriatric assessment
Study NCT03017196 — intervention group
Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: My Life, My Healthcare Discussion Aid
Description: The My Life, My Healthcare instrument is a conversational tool designed to help patients and clinicians discuss capacity in clinical conversations of primary care.
Study NCT03320174 — intervention group
Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Tafenoquine
Description: Tafenoquine 200mg
Study NCT03320174 — intervention group
Intervention type: OTHER
Group type: PLACEBO_COMPARATOR
Intervention: Placebo
Description: Placebo
Study NCT02145208 — intervention group
Intervention type: DEVICE
Group type: EXPERIMENTAL
Intervention: TIND System
Description: An implant
Study NCT01091870 — intervention group
Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Placebo
Description: Soluble blue pigment, 3 times a day, from the third to the 14th day after subarachnoid hemorrhage.
Study NCT01091870 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Sildenafil Citrate, 25 mg, 3 times a day.
Description: Sildenafil Citrate 25 mg, 3 times a day (TID)from the third to the 14 day after subarachnoid hemorrhage.
Study NCT01091870 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Sildenafil Citrate 50 mg, 3 times a day
Description: Sildenafil Citrate 25 mg, 3 times a day (TID)from the third to the 14 day after subarachnoid hemorrhage.
Study NCT03034837 — intervention group
Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: resin sealant
Description: Sealing the occlusal surface of the included molars using the market product of SDI conseal f once.
Study NCT03034837 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: ART sealant
Description: Sealing the occlusal surface of the included molars using the market product of 3M ESPE KetacTM Molar Easymix glass ionomer cement once.
Study NCT01096381 — intervention group
Intervention type: OTHER
Intervention: laboratory biomarker analysis
Description: Blood collection
Study NCT01096381 — intervention group
Intervention type: OTHER
Intervention: questionnaire administration
Description: Survey regarding baseline health and activity level.
Study NCT01918657 — intervention group
Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: walnut powder
Description: Subjects will be randomized in a 2:1 ratio into either an active treatment group (final dose 1500 mg walnut protein, n=20) or a placebo group (n=10). Subjects will undergo a one-day desensitization protocol designed to enable the subject to tolerate 6 mg of walnut protein or placebo (initial day escalation phase). After the initial escalation day achieving at least 1.5 mg and up to 6 mg of walnut protein or placebo, dosing build-up will occur every two weeks through dose 24 at 34 weeks. A maintenance dose will be given for 4 weeks followed by a 5 gram protein OFC to walnut and a 5 gram protein OFC to a second tree nut (at \~38 weeks), after which the study will be unblinded. Placebo subjects that fail the OFC will be crossed over to active treatment and escalated as described to the 1500 mg target dose.
Study NCT01918657 — intervention group
Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: walnut powder
Description: escalating doses of walnut powder
Study NCT03902470 — intervention group
Intervention type: PROCEDURE
Group type: ACTIVE_COMPARATOR
Intervention: Thoracic epidural anaesthesia video assisted thoracoscopic surgery
Description: Patients in (TEA) group will pre-medicated using midazolam 3-4 mg (IV)and fentanyl 50 mcg (IV). Then An epidural catheter will be inserted between T3-T4 and T4-T5 . A test dose (5 ml) of 2% lidocaine will be given, followed by 15-20 ml of bupivacain 0.5%.
Study NCT03902470 — intervention group
Intervention type: PROCEDURE
Group type: EXPERIMENTAL
Intervention: Thoracic epidural anaesthesia video assisted thoracoscopic surgery
Description: Patients in (TEA) group will pre-medicated using midazolam 3-4 mg (IV)and fentanyl 50 mcg (IV). Then An epidural catheter will be inserted between T3-T4 and T4-T5 . A test dose (5 ml) of 2% lidocaine will be given, followed by 15-20 ml of bupivacain 0.5%.
Study NCT03283930 — intervention group
Intervention type: BEHAVIORAL
Group type: EXPERIMENTAL
Intervention: Active Attention Bias Modification Training
Description: Computer-based attention bias modification training administered at weekly CBT session aimed at re-training attentional biases
Study NCT03283930 — intervention group
Intervention type: BEHAVIORAL
Group type: PLACEBO_COMPARATOR
Intervention: Placebo Attention Bias Modification Training
Study NCT01341093 — intervention group
Intervention type: BEHAVIORAL
Group type: EXPERIMENTAL
Intervention: educational program+telephone follow up
Description: Patients will participate in the educational program with telephone follow-up, the education program will initiate in preoperative period and will continue for six months.
Study NCT01341093 — intervention group
Intervention type: BEHAVIORAL
Group type: ACTIVE_COMPARATOR
Intervention: Usual care
Description: Patients will receive orientations about the surgery and the rehabilitation by health professionals, especially in the discharge. And will have return for evaluation scheduled by health professionals.
Study NCT00929344 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Pregabalin
Description: Two 150 mg capsules, 150 mg/am and 150 mg/pm (Total dose, 300mg/d), 12 week duration. Dose may be increased up to 600 mg/d or reduced to 150 mg/d based on subject response and tolerability.
Study NCT00929344 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Duloxetine
Description: 40 mg capsule, Once daily/am, 12 week duration, placebo capsule administered pm. Dose may be increased up to 60 mg/d or reduced to 20 mg/d based on subject response and tolerability.
Study NCT00929344 — intervention group
Intervention type: BEHAVIORAL
Group type: EXPERIMENTAL
Intervention: Standardized behavioral therapy
Description: Standardized behavioral therapy 1 time per week for 12 week duration.
Study NCT00929344 — intervention group
Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Placebo
Description: Matched placebo capsule administered 1 capsule am and 1 capsule pm for 12 week duration.