TrialPanorama/TrialPanorama-database huggingface dataset:
Study: NCT00103857
Drug: Comparator: MK0431 50 mg b.i.d. (b.i.d. = twice daily)
Approvals — FDA: no, EMA: no, PMDA: no
Description: MK0431 oral tablets will be started on Day 1 at 50 mg q.d. (q.d. = once daily) and increased after one week to a stable dose of 50 mg b.i.d. (b.i.d. = twice daily) Patients will continue to take MK0431 50 mg b.i.d. for the remainder of the 54-week base study (including the 24-week placebo-controlled Phase A and 30-week active-controlled Phase B) and during the 50-week extension study (for patients who complete the 54-week base study and enter the 50-week extension study) for a total treatment duration of up to 104 weeks.
Study: NCT00103857
Drug: Comparator: MK0431 100 mg q.d. (q.d. = once daily)
Approvals — FDA: no, EMA: no, PMDA: no
Description: MK0431 oral tablets will be started on Day 1 as two 50 mg tablets (100 mg q.d.) (q.d. = once daily) and continued at this dose throughout the 54-week base study (including the 24-week placebo-controlled Phase A and 30-week active-controlled Phase B) and the 50-week extension study (for patients who complete the 54-week base study and enter the 50-week extension study) for a total treatment duration of up to 104 weeks.
Study: NCT02600767
Drug: Artemether-lumefantrine combination
Normalized name: ARTEMETHER/LUMEFANTRINE
DrugBank: Lumefantrine co-artemether (DB13085)
Approvals — FDA: no, EMA: no, PMDA: no
Description: This is the sole arm in this study and it is the use of the standard combination therapy for treatment of P. falciparum malaria.
Study: NCT02716766
Drug: Capecitabine
Normalized name: Capecitabine
DrugBank: Capecitabine (DB01101)
Approvals — FDA: yes, EMA: no, PMDA: yes
Description: PO
Study: NCT02647255
Drug: Methylprednisolone pulse
Normalized name: Methylprednisolone
DrugBank: Methylprednisolone (DB00959)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: methylprednisolone 7-15mg/kg/d 3 times, Qd. or Qod
Study: NCT00237809
Drug: D-serine
Normalized name: D-Serine
DrugBank: D-Serine (DB03929)
Approvals — FDA: no, EMA: no, PMDA: no
Description: D-serine (30 mg/kg)
Study: NCT00901979
Drug: LCQ908A
Approvals — FDA: no, EMA: no, PMDA: no
Study: NCT00237809
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: Placebo D-serine Drug
Study: NCT00901979
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Study: NCT02613052
Drug: normal saline
Normalized name: Normal Saline Flush
Approvals — FDA: no, EMA: no, PMDA: no
Description: 10 mL of normal saline agitated prior to IV administration
Study: NCT01858623
Drug: Losartan/hydrochlorothiazide
Normalized name: losartan/hydrochlorothiazide 100 mg-25 mg ORAL TABLET
Approvals — FDA: no, EMA: no, PMDA: no
Study: NCT00777309
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: The placebo is provided as a capsule
Study: NCT02488733
Drug: CMT
Normalized name: CMT
Approvals — FDA: no, EMA: no, PMDA: no
Description: CMT consists in the use of the best treatment strategies, involving pharmacological and dietary therapies, lifestyle and physical activity, with the aim of both glycemic control and weight loss, administered on the basis of the current guidelines of the American Diabetes Association (ADA)\[50\] and determined on an individual basis \[52\].The administration of such pharmacological and non-pharmacological therapies will be adjusted in accordance with the algorithms of the ADA .
Study: NCT03639545
Drug: Placebos
Approvals — FDA: no, EMA: no, PMDA: no
Description: The patients receive for 12 weeks.
Study: NCT02751125
Drug: BCP with autologous mesenchymal stem cells (MSC).
Approvals — FDA: no, EMA: no, PMDA: no
Description: Augmentation of narrow alveolar ridge with BCP and MSC
Study: NCT02433899
Drug: 2.0% Mepivacaine + 1:100.000 epinephrine
Approvals — FDA: no, EMA: no, PMDA: no
Description: Regional block
Study: NCT02626494
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: 14 days before or after, placebo will be administered analogously as described with n-AC. Placebo will be given according to a double-blind, placebo-controlled cross-over design. Subjects receive 3 doses of placebo over 2 consecutive days (total dose=4800mg; individual doses=2x1200mg, 1x2400mg). Subjects will take 2 first doses (à 1200mg) of placebo 1 day before scanning (one in the morning, one in the evening), and the last dose (2400mg) 1h prior to scanning, with 12 hours dosing intervals in between. Preparation and blinding of placebo capsules will be performed by the Kantonsapotheke Zürich according to the guidelines of Good Manufacturing Practice.
Study: NCT04093050
Drug: Vasostrict Injectable Product
Normalized name: Vasostrict Injectable Product
Approvals — FDA: no, EMA: no, PMDA: no
Description: Vasostrict® (vasopressin injection, USP)
Study: NCT02076594
Drug: Capecitabine
Normalized name: Capecitabine
DrugBank: Capecitabine (DB01101)
Approvals — FDA: yes, EMA: no, PMDA: yes
Description: Film coated tablets
Study: NCT01429285
Drug: Usual care
Approvals — FDA: no, EMA: no, PMDA: no
Description: Attending administers any IV opioid in any dose he chooses
Study: NCT02923349
Drug: INCAGN01949
Approvals — FDA: no, EMA: no, PMDA: no
Description: Initial cohort dose of INCAGN01949 monotherapy at the protocol-defined starting dose, with subsequent cohort escalations based on protocol-specific criteria. The recommended dose will be taken forward into expansion cohorts.
Study: NCT02191540
Drug: Abnoba Viscum F 20mg
Approvals — FDA: no, EMA: no, PMDA: no
Description: intravesical instillation of five amples of AbnobaViscum® F20mg and 0.9% normal saline into the pleural space
Study: NCT00504205
Drug: multitargeted receptor tyrosine kinase inhibitor MP470
Normalized name: Tyrosine
DrugBank: Tyrosine (DB00135)
Approvals — FDA: yes, EMA: no, PMDA: no
Study: NCT06245902
Drug: Naltrexone and Acetaminophen
Normalized name: bupropion and naltrexone
Approvals — FDA: no, EMA: no, PMDA: no
Description: Naltrexone plus acetaminophen
Study: NCT06245902
Drug: Naltrexone and Acetaminophen-High Dose
Normalized name: bupropion and naltrexone
Approvals — FDA: no, EMA: no, PMDA: no
Description: Naltrexon (high dose) plus acetaminophen
Study: NCT06245902
Drug: Acetaminophen Alone
Normalized name: Acetaminophen
DrugBank: Acetaminophen (DB00316)
Approvals — FDA: no, EMA: no, PMDA: no
Description: Acetaminophen Alone plus Placebo
Study: NCT02735707
Drug: Standard course macrolide
Approvals — FDA: no, EMA: no, PMDA: no
Description: Standard course of macrolide therapy, discontinued between study day 3 and the end of study day 5.~The dosing of and route of administration is not protocolised, the following guidance is provided:~* Initial IV administration of a macrolide is strongly preferred~* The preferred IV macrolide is azithromycin, but IV clarithromycin may be substituted.~* The preferred enteral macrolide is azithromycin, but enteral clarithromycin or roxithromycin may be substituted.
Study: NCT00115167
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: Q4W
Study: NCT03824340
Drug: Doxycycline before ICSI
Normalized name: Doxycycline
DrugBank: Doxycycline (DB00254)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: Extra medication (Doxycycline ) group before ICSI :,women who will receive more medications (Doxycycline ) before starting the ICSI process
Study: NCT01692834
Drug: Sandimmune® Injection
Approvals — FDA: no, EMA: no, PMDA: no
Study: NCT01692834
Drug: NeuroSTAT®
Approvals — FDA: no, EMA: no, PMDA: no
Study: NCT02735707
Drug: Fixed-duration Hydrocortisone
Normalized name: Hydrocortisone
DrugBank: Hydrocortisone succinate (DB14545)
Approvals — FDA: yes, EMA: yes, PMDA: no
Description: 50mg of intravenous hydrocortisone will be administered every 6 hours for up to 7 days.~Note: this intervention is now closed.
Study: NCT02735707
Drug: Shock-dependent hydrocortisone
Normalized name: Hydrocortisone
DrugBank: Hydrocortisone succinate (DB14545)
Approvals — FDA: yes, EMA: yes, PMDA: no
Description: 50mg IV hydrocortisone every 6 hours while the patient is in septic shock
Study: NCT02735707
Drug: Fixed-duration higher dose Hydrocortisone
Normalized name: Hydrocortisone
DrugBank: Hydrocortisone succinate (DB14545)
Approvals — FDA: yes, EMA: yes, PMDA: no
Description: 100mg of intravenous hydrocortisone will be administered every 6 hours for up to 7 days.~Note: this intervention was only available to patients with suspected or proven COVID-19 and is now closed.
Study: NCT00255242
Drug: Simvastatin treatment for 28 days
Normalized name: Simvastatin
DrugBank: Simvastatin (DB00641)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: 40 mg / day
Study: NCT00882375
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: Placebo administered using novel NRT user instructions
Study: NCT02735707
Drug: Local standard venous thromboprophylaxis
Approvals — FDA: no, EMA: no, PMDA: no
Description: Standard venous thromboprophylaxis that complies with local guidelines or usual practice will be administered for 14 days following randomisation or until hospital discharge, whichever occurs first.~Note: this intervention is now closed.
Study: NCT02735707
Drug: Therapeutic dose anticoagulation
Normalized name: Moisturel Therapeutic
Approvals — FDA: no, EMA: no, PMDA: no
Description: Patients will be administered either low molecular weight heparin (LMWH) or unfractionated heparin (UFH) to achieve systemic anticoagulation. Either agent may be used and the same patient may be switched between UFH and LMWH at the discretion of the treating clinician.~Note: this intervention is now closed.
Study: NCT02735707
Drug: Intermediate dose thromboprophylaxis
Normalized name: Prevotella intermedia
Approvals — FDA: no, EMA: no, PMDA: no
Description: Intermediate dose thromboprophylaxis will be administered for 14 days following randomisation or until hospital discharge, whichever occurs first. Dosing is outlined in the relevant protocol documents for this domain.
Study: NCT01451840
Drug: Remifentanil
Normalized name: Remifentanil
DrugBank: Remifentanil (DB00899)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: Bolus dose of intravenous remifentanil 0.25 mcg/kg given once before emergence of general anesthesia
Study: NCT02735707
Drug: Continuation of therapeutic dose anticoagulation
Normalized name: Moisturel Therapeutic
Approvals — FDA: no, EMA: no, PMDA: no
Description: Patients already receiving therapeutic dose anticoagulation at the time of randomisation to this intervention will be administered either unfractionated heparin by IV infusion or low-molecular weight heparin to achieve systemic anticoagulation according to local practice for acute VTE treatment for 14 days following randomisation or until hospital discharge, whichever occurs first.~Note: this intervention is now closed.
Study: NCT00267865
Drug: Methotrexate
Normalized name: Methotrexate
DrugBank: Methotrexate (DB00563)
Approvals — FDA: yes, EMA: no, PMDA: yes
Description: 6000 mg/m\^2 will be administered by intravenous infusion over 4 hours after confirming that the recipient patients urine pH is within the range greater than or equal to 7 to less than or equal to 8, and urine output is greater than or equal to 100 mL/hour.
Study: NCT00267865
Drug: Leucovorin
Normalized name: Leucovorin
DrugBank: Leucovorin (DB00650)
Approvals — FDA: yes, EMA: no, PMDA: yes
Description: Leucovorin calcium doses will be administered orally or by short intravenous (IV) infusion over 15 minutes
Study: NCT00796575
Drug: CS-8080
Normalized name: MyoGesic-CS
Approvals — FDA: no, EMA: no, PMDA: no
Description: CS-8080 1mg tablets, 3 tablets administered 1 times per day
Study: NCT00796575
Drug: placebo tablets
Normalized name: placebo Oral Tablet
Approvals — FDA: no, EMA: no, PMDA: no
Description: placebo tablets matching active
Study: NCT00796575
Drug: CS-8080
Normalized name: MyoGesic-CS
Approvals — FDA: no, EMA: no, PMDA: no
Description: CS-8080 5 mg tablets, 2 tablets administered 1 times per day
Study: NCT00796575
Drug: CS-8080
Normalized name: MyoGesic-CS
Approvals — FDA: no, EMA: no, PMDA: no
Description: CS-8080 5 mg tablets, 4 tablets administered 1 times per day
Study: NCT00389285
Drug: rIL-21 only
Approvals — FDA: no, EMA: no, PMDA: no
Description: Part 1: rIL-21, IV, Day 1-5 and 15-19 of each 6-week treatment course
Study: NCT02735707
Drug: Simvastatin
Normalized name: Simvastatin
DrugBank: Simvastatin (DB00641)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: Simvastatin 80mg administered once daily via enteral route, while the patient remains in hospital up to 28 days after randomisation~Note: this intervention is now closed.
Study: NCT02735707
Drug: Angiotensin converting enzyme inhibitor
Approvals — FDA: no, EMA: no, PMDA: no
Description: Site-preferred ACEi agent administered as directed by the treating clinician for 10 days or until hospital discharge, whichever occurs first.~Note: this intervention is now closed.
Study: NCT02735707
Drug: ARB + DMX-200
Approvals — FDA: no, EMA: no, PMDA: no
Description: Site-preferred ARB agent administered in combination with DMX-200 for 10 days or until hospital discharge, whichever occurs first.~ARB administered as directed by the treating clinician. DMX-200 administered enterally at a dose of 120mg twice daily.~Note: this intervention is now closed.
Study: NCT02735707
Drug: Cysteamine
Normalized name: Cysteamine
DrugBank: Cysteamine (DB00847)
Approvals — FDA: no, EMA: no, PMDA: no
Description: Cysteamine administered every 8 hours at a dose of 5 mg/kg estimated or measured body weight (maximum dose of 500mg), for ten days or until ICU discharge, whichever occurs first.~Note: this intervention is now closed.
Study: NCT00071188
Drug: ZD6474
Approvals — FDA: no, EMA: no, PMDA: no
Study: NCT02614131
Drug: Placebo SC
Approvals — FDA: no, EMA: no, PMDA: no
Description: Administered SC
Study: NCT02614131
Drug: Placebo IV
Approvals — FDA: no, EMA: no, PMDA: no
Description: Administered IV
Study: NCT00296127
Drug: Celecoxib
Normalized name: Celecoxib
DrugBank: Celecoxib (DB00482)
Approvals — FDA: yes, EMA: no, PMDA: no
Study: NCT01238094
Drug: Simvastatin
Normalized name: Simvastatin
DrugBank: Simvastatin (DB00641)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: simvastatin 40 mg qd daily until disease progression
Study: NCT02473458
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Study: NCT05341102
Drug: LY3556050
Approvals — FDA: no, EMA: no, PMDA: no
Description: Administered orally.
Study: NCT05341102
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: Administered orally.
Study: NCT00543920
Drug: MK0777
Approvals — FDA: no, EMA: no, PMDA: no
Study: NCT01923935
Drug: BUSULFEX®
Approvals — FDA: no, EMA: no, PMDA: no
Description: BUSULFEX® 3.2 mg/kg/day iv once daily over 3 hours (day-6\~day-4)
Study: NCT01923935
Drug: Alkeran®
Approvals — FDA: no, EMA: no, PMDA: no
Description: Alkeran® 70 mg/m2/day iv once daily over 30 minutes (day-3\~day-2)
Study: NCT03853525
Drug: BAY207543 (Bepanthol, Bepantol® Derma Spray)
Normalized name: Derma Gran Spray
Approvals — FDA: no, EMA: no, PMDA: no
Description: Product is applied to one side of the inguinal region.
Study: NCT02477280
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: Medikinet
Study: NCT01090310
Drug: AIN457
Approvals — FDA: no, EMA: no, PMDA: no
Description: AIN457 150 mg powder for solution was provided in glass vials each containing 150 mg AIN457 as a lyophilized cake
Study: NCT00445198
Drug: ABT-263
Normalized name: ABT-925
Approvals — FDA: no, EMA: no, PMDA: no
Description: Phase 1 dosing under two different schedules: 14 days on drug, 7 days off or continuous dosing.~- 50 patients with SCLC and non-hematologic malignancies. Enrollment is closed in this arm of the study.~Phase 2a dosing under two different schedules: 14 days on drug, 7 days off or continuous dosing.~- 40 patients with SCLC
Study: NCT02893618
Drug: Diazoxide choline controlled-release tablet
Normalized name: diazoxide Oral Tablet
Approvals — FDA: no, EMA: no, PMDA: no
Description: QD tablet formulation of choline salt of diazoxide
Study: NCT03315611
Drug: 'Eucerin AtopiControl Lotion' (for the body)
Approvals — FDA: no, EMA: no, PMDA: no
Description: Treatment with Eucerin AtopiControl Lotion
Study: NCT01945086
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: Participants will receive SC injections of placebo at Week 0 and Week 4.
Study: NCT00772005
Drug: placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: placebo
Study: NCT01606202
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: Contained peppermint oil, 0.05% (v/v), quinoline yellow, 0.005% (w/v), sunset yellow, 0.0025% (w/v), in ethanol:propylene glycol (50:50) excipient. Each actuation delivered 100 μl. The maximum permitted dose of study medication was eight actuations in any three-hour period, and 48 actuations in any 24 hour period.
Study: NCT01481272
Drug: Methotrexate
Normalized name: Methotrexate
DrugBank: Methotrexate (DB00563)
Approvals — FDA: yes, EMA: no, PMDA: yes
Description: 12mg, it, on day 5 of each 21 days cycle, maximum 6 cycles
Study: NCT01481272
Drug: Leukovorin
Approvals — FDA: no, EMA: no, PMDA: no
Description: 15mg, po 24 hours after methotrexate it
Study: NCT00212290
Drug: placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Study: NCT02760056
Drug: Liothyronine sodium
Normalized name: Liothyronine Sodium
DrugBank: Liothyronine (DB00279)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: Subjects will be divided into 4 groups of progressively escalating doses. Each group will have 6 subjects 4 will receive the active treatment and 2 will receive the placebo. The first group will receive 25 mcg twice daily for one week. The second group will receive 37.5 mcg twice daily for one week. The third group will receive 50 mcg twice daily for one week. The forth group will receive 75 mcg twice daily for one week.
Study: NCT02760056
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: Patient will receive a matching placebo to take twice daily for one week.
Study: NCT00762554
Drug: Fentanyl
Normalized name: Fentanyl
DrugBank: Fentanyl (DB00813)
Approvals — FDA: yes, EMA: no, PMDA: yes
Description: Epidural fentanyl infusion started after spinal bupivacaine used for the cesarean section.
Study: NCT01160484
Drug: DVD-R
Normalized name: pantolactone, (R)-
Approvals — FDA: no, EMA: no, PMDA: no
Description: 40 mg dexamethasone will be administered IV on Days 1, 4, 8, and 11 of each cycle. 1.0 mg/m2 Bortezomib will be administered IV over 3 to 5 seconds followed by a standard saline flush, on Days 1, 4, 8, and 11 immediately following the dexamethasone infusion. 4.0 mg/m2 PLD will be given as a 90 minute infusion on Day 1 of Cycle 1 and subsequent doses may be administered over 30 to 60 minutes on Days 4, 8 and 11 of Cycle 1 and on Days 1, 4, 8, and 11 of each subsequent cycle, following the bortezomib administration. 10 mg/day lenalidomide will be administered PO on days 1-14 of a 28-day treatment cycle, followed by a 14-day rest period, following the PLD administration.
Study: NCT03161652
Drug: DME lactose pill
Normalized name: lactose Pill
Approvals — FDA: no, EMA: no, PMDA: no
Description: Patients with DME will take placebo orally 3 times a day (TID) for 8 weeks.The placebo is taken on top of standard therapy for diabetes and blood pressure control.
Study: NCT00719914
Drug: normal saline
Normalized name: Normal Saline Flush
Approvals — FDA: no, EMA: no, PMDA: no
Description: Intra-coronary injection, weight based, of normal saline.
Study: NCT03161652
Drug: DR lactose pill
Normalized name: lactose Pill
Approvals — FDA: no, EMA: no, PMDA: no
Description: Patients with non-proliferative DR will take a lactose pill (placebo) orally TID for 8 weeks. The placebo is taken on top of standard therapy for diabetes and blood pressure control.
Study: NCT03161652
Drug: DR vitrectomy lactose pill
Normalized name: lactose Pill
Approvals — FDA: no, EMA: no, PMDA: no
Description: Patients with proliferative DR (undergoing medically prescribed vitrectomy 7 days after starting the study medication) will have to take a lactose pill (placebo) orally TID for one week. The last placebo pill will be taken on the morning of the day vitrectomy is performed. The placebo is taken on top of standard therapy for diabetes and blood pressure control.
Study: NCT03161652
Drug: DME plus ranibizumab lactose pill
Normalized name: lactose Pill
Approvals — FDA: no, EMA: no, PMDA: no
Description: Patients with DME with conventional intravitreal antiangiogenic therapy with ranibizumab (0.5 mg every 4 weeks for 12 weeks) will take a lactose pill (placebo) orally TID for 24 weeks. The placebo is taken on top of standard therapy for diabetes and blood pressure control.
Study: NCT01561599
Drug: Normal Saline
Normalized name: Normal Saline Flush
Approvals — FDA: no, EMA: no, PMDA: no
Description: Daily intravenous administration for four (4) days. The volume of normal saline will vary by estimated weight.
Study: NCT04560049
Drug: Phenol
Normalized name: Phenol
DrugBank: Phenol (DB03255)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: phenolisation of sinus tract
Study: NCT02033200
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Study: NCT03596697
Drug: CRV431
Approvals — FDA: no, EMA: no, PMDA: no
Description: Single or multiple dose(s) of CRV431
Study: NCT03596697
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: Single Placebo dose
Study: NCT03578146
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Study: NCT03066219
Drug: BRM421
Approvals — FDA: no, EMA: no, PMDA: no
Description: A topical solution of BRIM421 ophthalmic drops
Study: NCT03066219
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: vehicle ophthalmic drops
Study: NCT02150070
Drug: ASP2408
Approvals — FDA: no, EMA: no, PMDA: no
Description: Intravenous (IV) infusion and subcutaneous (SC) injection
Study: NCT02150070
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: Intravenous (IV) infusion and Subcutaneous (SC) injection
Study: NCT01362309
Drug: d-cycloserine.
Approvals — FDA: no, EMA: no, PMDA: no
Description: 50 mg administered on two occasions.
Study: NCT01672255
Drug: Fluoxetine
Normalized name: Fluoxetine
DrugBank: Fluoxetine (DB00472)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: 20 mg week 1, 40 mg week 2, 60 mg week 3, 80 mg week 4-6
Study: NCT01672255
Drug: Placebo control
Approvals — FDA: no, EMA: no, PMDA: no
Description: 20 mg Week 1, 40 mg Week 2, 60 mg Week 3, 80 mg Week 4-6
Study: NCT02880293
Drug: Cyclophosphamide
Normalized name: Cyclophosphamide
DrugBank: Cyclophosphamide (DB00531)
Approvals — FDA: yes, EMA: no, PMDA: yes
Description: cyclophosphamide (50 mg/kg IV on day +3 and +4)
Study: NCT02994602
Drug: Nestorone + Testosterone Combination Gel
Normalized name: Testosterone
DrugBank: (1,2,6,7-3H)Testosterone (DB14093)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: The combined gel is a transdermal treatment that will be applied as three single applications to a male subject's arms and shoulders on three different treatment days. The formulation will be a hydro alcoholic gel containing about 1.43% T (14.3 mg T/g gel). About 9 to 14% of the steroid (T or NES) in the gel applied is available to the body. The amount of gel to be applied each application will be approximately 5 mL in volume. The gel application volume will contain 62.5 mg of T that will deliver approximately 6 mg T to the body per day (Swerdloff et al., 2000; Wang et al., 2000). This gel volume will also contain 8.3 mg of NES that will deliver about 0.8 mg of NES to the body per day (NES 8 mg/d + T 60 mg/d (NES8/T60) gel).
Study: NCT02753205
Drug: normal saline
Normalized name: Normal Saline Flush
Approvals — FDA: no, EMA: no, PMDA: no
Description: infusion of normal saline