TrialPanorama/TrialPanorama-database huggingface dataset:
Study: NCT02714998
Drug: Methotrexate
Normalized name: Methotrexate
DrugBank: Methotrexate (DB00563)
Approvals — FDA: yes, EMA: no, PMDA: yes
Description: single dose systemic methotrexate administration (50 mg/m2)
Study: NCT02502188
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Study: NCT00267956
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: The patients will receive placebo subcutaneous injection on Weeks 0, 1, 2, and 3; At weeks 12 and 16 the patients will receive CNTo1275 90 mg (or 63 mg after filtration) subcutaneous injection
Study: NCT01093651
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: Daily placebo for 4-6 months
Study: NCT02958722
Drug: physiological solution
Approvals — FDA: no, EMA: no, PMDA: no
Study: NCT00599625
Drug: Pravastatin
Normalized name: Pravastatin
DrugBank: Pravastatin (DB00175)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: 80mg administered daily for 6 consecutive weeks
Study: NCT03804866
Drug: Pegylated liposomal doxorubicin
Approvals — FDA: no, EMA: no, PMDA: no
Description: 50 mg/m² iv every 4 weeks until confirmed evidence of disease progression
Study: NCT03804866
Drug: Doxorubicin
Normalized name: Doxorubicin
DrugBank: Doxorubicin (DB00997)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: 60 mg/m² iv every 3 weeks for a maximum of 8 cycles
Study: NCT02256553
Drug: Rescue Medication
Normalized name: ALLERGENIC EXTRACT, MEADOW FESCUE POLLEN
Approvals — FDA: no, EMA: no, PMDA: no
Description: Self-injectable epinephrine, to be administered for an anaphylactic reaction, including symptoms/signs of upper airway obstruction.
Study: NCT02385539
Drug: The impact of 10 independent variables on the likelihood of not developing hypotension after intrathecal injection.
Approvals — FDA: no, EMA: no, PMDA: no
Description: The study will be conducted to assess the impact of a 10 independent variables (dose and combination of Levobupivacaine with Fentanyl or Sufentanil, age, basal systolic blood pressure (SBP), basal mean arterial pressure (MAP), time to lowest spinal SBP, upper limit of sensory block (dermatoma level), time intervals of sensory recovery for two consecutive dermatoma level (two-segment regression), time intervals of sensory recovery to the twelfth thoracic dermatoma (T12 regression), time intervals of sensory recovery to the first sacral dermatoma (S1 regression) and Body Mass Index) on the likelihood of not developing hypotension after intrathecal injection.
Study: NCT04471415
Drug: DRP-104
Approvals — FDA: no, EMA: no, PMDA: no
Description: DRP-104 administered intravenously over 1 hour, three times per week (TIW) (Monday, Wednesday, Friday) for 2 consecutive weeks, one week off~DRP-104 administered subcutaneously twice weekly (Monday/Thursday or Tuesday/Friday) every week OR thrice weekly (Monday, Wednesday, Friday) every week
Study: NCT04391439
Drug: Intravenous Methylprednisolone
Normalized name: Methylprednisolone
DrugBank: Methylprednisolone (DB00959)
Approvals — FDA: yes, EMA: no, PMDA: no
Study: NCT00773058
Drug: hydrocortisone
Normalized name: Hydrocortisone
DrugBank: Hydrocortisone succinate (DB14545)
Approvals — FDA: yes, EMA: yes, PMDA: no
Description: hydrocortisone 100mg q8h
Study: NCT00773058
Drug: placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: normal saline 100ml q8h
Study: NCT02212275
Drug: Dextromethophan
Normalized name: THROAT LOZENGE W/BENZOCAINE,DEXTROMETHOPHAN
Approvals — FDA: no, EMA: no, PMDA: no
Description: A single age and weight appropriate dose of over the counter Delsym Cough Syrup containing only DXM as an active ingredient.
Study: NCT01180400
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: Tablet, oral, twice daily for 8 weeks
Study: NCT05070468
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: Pregnant women with a gestational age of 38 weeks and older admitted to Labor Of Kamali Hospital, for termination of pregnancy, by accident and based on the coding done by a statistician to identify groups of users of pill A or pill B, 14 pills are used vaginally . The client and the researcher are blinded and the pharmacist delivers the dexamethasone and placebo tablets with codes A and B to the researcher.
Study: NCT00442559
Drug: inhaled corticosteroid
Normalized name: CORTICOSTEROIDS
Approvals — FDA: no, EMA: no, PMDA: no
Description: Inhaled corticosteroid solution, 1-4 puffs daily, 12 weeks to up to 12 months
Study: NCT00668057
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: 5 mg matching placebo
Study: NCT00668057
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: 10 mg matching placebo
Study: NCT00668057
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: 20 mg matching placebo
Study: NCT05533788
Drug: ABSK091 tablet
Approvals — FDA: no, EMA: no, PMDA: no
Description: ABSK091 tablet which is being developed for the treatment of patients with advanced solid tumors
Study: NCT03507452
Drug: BAY2287411
Approvals — FDA: no, EMA: no, PMDA: no
Description: Dose Escalation part:~A single dose will be administered intravenously on Day 1 of each cycle lasting 6 weeks (42 days).
Study: NCT03507452
Drug: BAY2287411
Approvals — FDA: no, EMA: no, PMDA: no
Description: Dose Expansion part:~The selection of the dose level(s) /regimen(s) to be evaluated will be based on the overall benefit / risk and PK profile observed in the dose escalation.
Study: NCT00337246
Drug: cyclophosphamide
Normalized name: Cyclophosphamide
DrugBank: Cyclophosphamide (DB00531)
Approvals — FDA: yes, EMA: no, PMDA: yes
Study: NCT00098735
Drug: FTY720
Approvals — FDA: no, EMA: no, PMDA: no
Study: NCT00157209
Drug: Single low dose cyclophosphamide
Approvals — FDA: no, EMA: no, PMDA: no
Description: A single intravenous infusion of 300 milligram per square meter (mg/m\^2) (to a maximum 600 mg) of cyclophosphamide will be given 3 days before the first vaccine treatment.
Study: NCT02299011
Drug: Biomatrix drug eluting stent
Normalized name: castor fiber scent gland secretion
Approvals — FDA: no, EMA: no, PMDA: no
Description: Biomatrix Flex drug eluting stent
Study: NCT01887002
Drug: Placebo comparator
Approvals — FDA: no, EMA: no, PMDA: no
Description: ONO-2952 Matching Placebo every day for 2 weeks
Study: NCT00554814
Drug: Bledilait Biofer®
Approvals — FDA: no, EMA: no, PMDA: no
Description: Bledilait Biofer® 2 mg/100 kcal
Study: NCT00554814
Drug: Blédilait Biofer®
Approvals — FDA: no, EMA: no, PMDA: no
Description: Blédilait Biofer® milk (1,1mg/100kcal)
Study: NCT00003049
Drug: fluorouracil
Normalized name: Fluorouracil
DrugBank: Fluorouracil (DB00544)
Approvals — FDA: yes, EMA: no, PMDA: yes
Study: NCT00003049
Drug: leucovorin calcium
Normalized name: Leucovorin Calcium
DrugBank: Leucovorin (DB00650)
Approvals — FDA: yes, EMA: no, PMDA: yes
Study: NCT01048905
Drug: L-Glutamine
Normalized name: L-Glutamine
DrugBank: L-Glutamine (DB00130)
Approvals — FDA: no, EMA: no, PMDA: no
Description: Oral L-glutamine 10 grams TID or (0.1g/kg TID) for children \< 15 years of age.
Study: NCT01911780
Drug: placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: placebo matching amlodipine capsule
Study: NCT03436199
Drug: ADS-5102, 137 mg
Approvals — FDA: no, EMA: no, PMDA: no
Description: Oral capsules
Study: NCT03436199
Drug: ADS-5102, 274 mg
Approvals — FDA: no, EMA: no, PMDA: no
Description: Oral capsules
Study: NCT01910220
Drug: REGN1033 (SAR391786)
Approvals — FDA: no, EMA: no, PMDA: no
Study: NCT00910455
Drug: SRX246
Approvals — FDA: no, EMA: no, PMDA: no
Description: single oral dose of SRX246 capsule
Study: NCT00910455
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: Single oral dose of placebo capsule
Study: NCT02540395
Drug: 6-methyl prednisolone (Steroids) (for Group B)
Normalized name: 6-methyl citronellol
Approvals — FDA: no, EMA: no, PMDA: no
Description: At the time of surgery, all patients will receive 500mg of 6-methyl prednisolone (Steroids, Urbason, Methypred).~Patients in group B will receive 250mg of 6-methyl prednisolone (or equivalent) on day 2, 125 mg on day 3, 60 mg on day 4 and 30 mg on day 5. From day 6 on, patients will receive 0.25 mg/kg/d of 6-methyl-prednisolone (Steroids, Urbason, Methypred) until month 1, then tapering until discontinuation on month 2 will be performed.
Study: NCT02540395
Drug: 6-methyl prednisolone (Steroids) (for Group A)
Normalized name: 6-methyl citronellol
Approvals — FDA: no, EMA: no, PMDA: no
Description: At the time of surgery, all patients will receive 500 mg of 6-methyl prednisolone (steroids for Group A).~Patients in arm A will receive 20 mg/day of 6-methyl prednisolone (steroids for Group A) (or the equivalent) during the first 2 weeks after transplantation, then tapering to 15 mg from week 3 to week 4 to finally be maintained at 5mg/day.
Study: NCT03188887
Drug: corticotherapy
Approvals — FDA: no, EMA: no, PMDA: no
Description: 3 IV pulses steroids followed by oral steroids for 4 months
Study: NCT00456235
Drug: Ciclosporine A
Approvals — FDA: no, EMA: no, PMDA: no
Study: NCT03004924
Drug: SHP640
Approvals — FDA: no, EMA: no, PMDA: no
Description: Instill 1 drop of SHP640 (povidone-iodine \[PVPI\] 0.6% and Dexamethasone 0.1%) ophthalmic suspension in each eye QID (with a minimum of 2 hours between doses) for 7 days.
Study: NCT03029585
Drug: NanoPac® 100 mg/m2
Approvals — FDA: no, EMA: no, PMDA: no
Description: Single intraperitoneal injection of 100 mg/m2 NanoPac® during cytoreductive surgery, followed by standard-of-care IV carboplatin and IV paclitaxel treatment
Study: NCT03029585
Drug: NanoPac® 200 mg/m2
Approvals — FDA: no, EMA: no, PMDA: no
Description: Single intraperitoneal injection of 200 mg/m2 NanoPac® during cytoreductive surgery, followed by standard-of-care IV carboplatin and IV paclitaxel treatment
Study: NCT03029585
Drug: NanoPac® 300 mg/m2
Approvals — FDA: no, EMA: no, PMDA: no
Description: Single intraperitoneal injection of 300 mg/m2 NanoPac® during cytoreductive surgery, followed by standard-of-care IV carboplatin and IV paclitaxel treatment
Study: NCT03029585
Drug: NanoPac® 400 mg/m2
Approvals — FDA: no, EMA: no, PMDA: no
Description: Single intraperitoneal injection of 400 mg/m2 NanoPac® during cytoreductive surgery, followed by standard-of-care IV carboplatin and IV paclitaxel treatment
Study: NCT03029585
Drug: Standard of Care Intravenous Chemotherapy
Approvals — FDA: no, EMA: no, PMDA: no
Description: Cytoreductive surgery followed by standard-of-care IV carboplatin and IV paclitaxel treatment
Study: NCT03004924
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: Instill 1 drop of placebo ophthalmic solution in each eye 4 times QID (with a minimum of 2 hours between doses) for 7 days.
Study: NCT01581476
Drug: Statin
Normalized name: Statin
Approvals — FDA: no, EMA: no, PMDA: no
Description: 10mg daily for a minimum period of 2 years
Study: NCT01581476
Drug: ACE inhibitor
Normalized name: ACE INHIBITORS
Approvals — FDA: no, EMA: no, PMDA: no
Description: Starting dose of 5mg daily rising after 14 days to 10mg daily providing it is well tolerated for a minimum period of 2 years.
Study: NCT01581476
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: Participants receive statin placebo and ACEI placebo
Study: NCT02148120
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Study: NCT00903981
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: 2 Tablets(Placebo 100mg tablet + Placebo 200mg tablet), 30 minutes before sexual intercourse
Study: NCT01420328
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: Placebo treatment for 6 weeks
Study: NCT00864136
Drug: Conventional medical treatment
Normalized name: zinc pyrithione Medicated Shampoo [Head & Shoulders Damage Treatment]
Approvals — FDA: no, EMA: no, PMDA: no
Description: Women using combined oral contraceptives, oral/injectable progestogens, non-steroidal anti-inflammatory drug
Study: NCT00864136
Drug: Conventional medical treatment
Normalized name: zinc pyrithione Medicated Shampoo [Head & Shoulders Damage Treatment]
Approvals — FDA: no, EMA: no, PMDA: no
Description: Women using anti-fibrinolytic agent for treatment of menorrhagia
Study: NCT00668746
Drug: Minocycline HCl microspheres
Normalized name: minocycline HCl microspheres
Approvals — FDA: no, EMA: no, PMDA: no
Description: At Baseline and all interim visits, a single unit dose of 1mg minocycline HCl (with approximately 3mg PGLA) will be professionally administered subgingivally into periodontal pockets at each site exhibiting a PD ≥ 5mm.
Study: NCT03362294
Drug: GA Depot 40mg once monthly
Normalized name: methylPREDNISolone acetate 40 MG/ML [DEPO-Medrol]
Approvals — FDA: no, EMA: no, PMDA: no
Description: Once-a-month long-acting intramuscular injection of 40mg Glatiramer Acetate (GA Depot)
Study: NCT04184622
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: Administered SC
Study: NCT00892970
Drug: Azithromycin ophthalmic solution, 1%
Approvals — FDA: no, EMA: no, PMDA: no
Description: One drop in each eye twice a day for the first two days; then one drop in each eye once a day for 12 days
Study: NCT00892970
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: One drop in each eye twice a day for the first two days; then one drop in each eye once a day for 12 days
Study: NCT01668498
Drug: Erythromycin
Normalized name: Erythromycin
DrugBank: Erythromycin (DB00199)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: Comparison of efficacy of Arm A erythromycin cream 2% daily at bedtime (doxycycline 100mg b.i.d.if skin toxicity CTC° ≥2) and Arm B doxycycline 100mg b.i.d. in patients with Metastatic Colorectal cancer (Ras wild-type)being treated with panitumumab.
Study: NCT01668498
Drug: Doxycycline
Normalized name: Doxycycline
DrugBank: Doxycycline (DB00254)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: Comparison of efficacy of Arm A erythromycin cream 2% daily at bedtime (doxycycline 100mg b.i.d.if skin toxicity CTC° ≥2) and Arm B doxycycline 100mg b.i.d. in patients with Metastatic Colorectal cancer (Ras wild-type)being treated with panitumumab.
Study: NCT01123005
Drug: EF5
Normalized name: Hb 76(EF5), Met-thr
Approvals — FDA: no, EMA: no, PMDA: no
Description: 10 mCi, IV
Study: NCT05686772
Drug: Dopamine partial agonists
Normalized name: Dopamine agonists
Approvals — FDA: no, EMA: no, PMDA: no
Description: Use of antipsychotics (i.e., dopamine partial agonists vs dopamine antagonists)
Study: NCT00538174
Drug: placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: Tablets, Oral, 0 mg, once daily, up to 14 days
Study: NCT00856661
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: IV, single bolus over 1 to 2 minutes on 1st day
Study: NCT01980615
Drug: Inhaled BGF (PT010) Dose 2
Approvals — FDA: no, EMA: no, PMDA: no
Study: NCT01980615
Drug: Inhaled BGF (PT010) Dose 3
Approvals — FDA: no, EMA: no, PMDA: no
Study: NCT01984801
Drug: 0.3% GSK1940029 gel
Approvals — FDA: no, EMA: no, PMDA: no
Description: 200 mg of the gel will be applied to individual patches by using a spatula
Study: NCT01984801
Drug: 1% GSK1940029 gel
Approvals — FDA: no, EMA: no, PMDA: no
Description: 200 mg of the gel will be applied to individual patches by using a spatula
Study: NCT01984801
Drug: 0.3%/1% vehicle gel only
Approvals — FDA: no, EMA: no, PMDA: no
Description: 200 mg of the gel will be applied to individual patches by using a spatula
Study: NCT01121198
Drug: placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: oral
Study: NCT02602002
Drug: Remifentanil
Normalized name: Remifentanil
DrugBank: Remifentanil (DB00899)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: IV
Study: NCT02602002
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: Placebo
Study: NCT01768572
Drug: methotrexate
Normalized name: Methotrexate
DrugBank: Methotrexate (DB00563)
Approvals — FDA: yes, EMA: no, PMDA: yes
Description: Dispensed according to local practice.
Study: NCT00840242
Drug: Placebo gum
Approvals — FDA: no, EMA: no, PMDA: no
Description: 8-12 pieces per day, maximum 24 daily
Study: NCT00840242
Drug: Placebo inhaler
Approvals — FDA: no, EMA: no, PMDA: no
Description: 6-12 cartridges per day, maximum 12 daily
Study: NCT01279447
Drug: Normal Saline
Normalized name: Normal Saline Flush
Approvals — FDA: no, EMA: no, PMDA: no
Description: 10cc, single dose, US guided injection
Study: NCT03888183
Drug: salt solution without 0.15% HA
Approvals — FDA: no, EMA: no, PMDA: no
Description: received AIM Artificial Tears (4 to 8 times per day) with 12 weeks
Study: NCT03888183
Drug: preservative-free 0.15% HA
Approvals — FDA: no, EMA: no, PMDA: no
Description: received Per-Young Eye Drops (4 to 8 times per day) with 12 weeks
Study: NCT01906073
Drug: intranasal fentanyl spray
Normalized name: fentanyl Mucosal Spray
Approvals — FDA: no, EMA: no, PMDA: no
Study: NCT03248076
Drug: Fentanyl Citrate
Normalized name: Fentanyl Citrate
DrugBank: Fentanyl (DB00813)
Approvals — FDA: yes, EMA: no, PMDA: yes
Description: 1γ/Kg fentanyl
Study: NCT00889863
Drug: placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: Placebo powder matching canakinumab supplied as 6 mL glass vials containing a lyophilized cake for subcutaneous injection every 4 weeks in Part II.
Study: NCT03186482
Drug: Descovy® (TAF/FTC)
Approvals — FDA: no, EMA: no, PMDA: no
Description: 25/200 mg once daily for 28 days (DAYS 1-28).
Study: NCT03186482
Drug: Viread® (TDF)
Approvals — FDA: no, EMA: no, PMDA: no
Description: 245 mg once daily for 28 days (DAYS 57-84).
Study: NCT03186482
Drug: Rifadin® (Rifampicin)
Approvals — FDA: no, EMA: no, PMDA: no
Description: 600 mg once daily for 28 days (DAYS 29-56).
Study: NCT00346801
Drug: Celecoxib
Normalized name: Celecoxib
DrugBank: Celecoxib (DB00482)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: 100 mg by mouth (PO) twice daily for 5 days before beginning radiation therapy; continued 7 days per week throughout radiation treatment (about 7 weeks).
Study: NCT00346801
Drug: CPT-11
Approvals — FDA: no, EMA: no, PMDA: no
Description: 30 mg/m\^2 IV over 90 minutes on Day 1, Weeks 2-8, followed by cisplatin which will be infused for 60 minutes.
Study: NCT03393702
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: 1. Patients in this arm of the study receive identical placebo capsules 1 hour before surgery.~2. Patients after surgery receive identical placebo capsules 2 times per day.
Study: NCT03192644
Drug: epidoxorubicin and cisplatin and lipiodol
Normalized name: Cisplatin
DrugBank: Cisplatin (DB00515)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: epidoxorubicin and cisplatin and lipiodol
Study: NCT00550550
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: Placebo sublingual tablet, once daily
Study: NCT02951806
Drug: (R) Rapid spinal fentanyl injection
Normalized name: Fentanyl
DrugBank: Fentanyl (DB00813)
Approvals — FDA: yes, EMA: no, PMDA: yes
Description: Patients will receive 25 micrograms fentanyl ( after dilution with 2.5 ml CSF) in 20 seconds then 10 mg hyperbaric bupivacaine.
Study: NCT02951806
Drug: (S) Slow spinal fentanyl injection
Normalized name: Slow-Fe
Approvals — FDA: no, EMA: no, PMDA: no
Description: Patients will receive 25 micrograms fentanyl ( after dilution with 2.5 ml CSF) in 90 seconds then 10 mg hyperbaric bupivacaine.
Study: NCT04379310
Drug: ACE Inhibitors and Calcium Channel Blockers
Normalized name: ACE inhibitors and calcium channel blockers
Approvals — FDA: no, EMA: no, PMDA: no
Description: effect of drugs on patients with covid-19 pneumonia
Study: NCT00257205
Drug: CP-675,206
Approvals — FDA: no, EMA: no, PMDA: no
Description: CP-675,206 15 mg/kg IV Q 90 days x 4
Study: NCT03345628
Drug: Sedatives
Normalized name: SEDATIVES/HYPONTICS
Approvals — FDA: no, EMA: no, PMDA: no
Description: sedated group received sedative drugs to tolerated intubation and ventilation
Study: NCT00803205
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: Placebo matching to ataluren will be provided.
Study: NCT04296851
Drug: placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: The subjects will be randomly assigned in a 2:1 ratio to receive niclosamide or identical-appearing placebo tablets orally for 6 months: niclosamide 650mg once a day in arm 1, placebo once a day in arm 2.
Study: NCT03611985
Drug: Epidiferphane
Approvals — FDA: no, EMA: no, PMDA: no
Description: During the phase I portion of the study, subjects will be assigned to take either two (half target dose) or four (full target dose) Epidiferphane tablets orally three times daily following a 3 + 3 design. Three subjects will be sequentially enrolled at each of the 2 dose levels (beginning with the half target dose) until at least one dose-limiting toxicity (DLT) occurs. Dosing escalation will be stopped if two or more DLTs occur at either dose level. The maximum tolerated dose will be one dose level lower than the dose level at which 2 or more DLTs occur. Dose escalation will occur separately for each of the two taxane regimens (weekly paclitaxel or docetaxel every 3 weeks).~All subjects in the phase IIa portion of the study will receive the maximum tolerated dose determined in the phase I portion of the study for their taxane regimen.~Subjects in both portions of the study will receive treatment with Epidiferphane for a maximum of three months.
Study: NCT03611985
Drug: Taxane Chemotherapy
Normalized name: acetaminophen / oxycodone hydrochloride Oral Capsule [Taxadone]
Approvals — FDA: no, EMA: no, PMDA: no
Description: All subjects on both phases of the study will be concurrently treated with a taxane regimen containing either paclitaxel given weekly or docetaxel given every 3 weeks. The choice of taxane regimen will be determined by the treating physician prior to consenting to participate in this trial.
Study: NCT03772899
Drug: Fecal Microbial Transplantation
Approvals — FDA: no, EMA: no, PMDA: no
Description: All patients in this trial will receive FMT at least one week prior to treatment with approved immunotherapy (either pembrolizumab or nivolumab). Samples for FMT are sourced at and by the microbiology group under the supervision of Dr. Silverman at St Joseph's Hospital. Donor screening procedures are described in appendix 4. Transplant will be from one single donor for all participants unless Dr. Silverman's lab considers the need for more than one donor based on availability of donors. There will be no mixture of donor samples.~Donor samples are manufactured into capsules according to Kao et al, 2017.
Study: NCT00818519
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: Inert tablet
Study: NCT03747575
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: Participants will receive SC placebo
Study: NCT01292005
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: 400 mg, 3 times daily by mouth from time of enrollment until 72 hours from enrollment. Subjects received up to a maximum of 9 doses.
Study: NCT00498797
Drug: Prednisolone
Normalized name: Prednisolone
DrugBank: Prednisolone acetate (DB15566)
Approvals — FDA: yes, EMA: no, PMDA: no
Study: NCT03867123
Drug: LAM561
Approvals — FDA: no, EMA: no, PMDA: no
Description: Arm 1: Daily for 6 weeks. Arm 2: daily, two 28-day cycles
Study: NCT01911819
Drug: Equimatrix
Approvals — FDA: no, EMA: no, PMDA: no
Description: Equimatrix cancellous particle size 0.2-1mm approximately 2g (4cc)
Study: NCT01911819
Drug: Bio-oss
Normalized name: Bio-Kool
Approvals — FDA: no, EMA: no, PMDA: no
Description: Bio-oss small granules cancellous 0.25-1mm, approximately 2g (4cc)