TrialPanorama/TrialPanorama-database huggingface dataset:
Study: NCT03620136
Drug: locoregional analgesia by periarticular local infiltrations
Approvals — FDA: no, EMA: no, PMDA: no
Description: A placebo injection to the adductor channel of 20 mL of physiological serum will be performed in the pre-induction room before surgery, according to the same procedures as the patients of the ACB group.~During the surgical procedure, patients in the ILA group will receive a total dose of 300mg of ROPIVACAINE 2mg / ml in the form of 3 periarticular injections. The first injection of 50mL of ROPIVACAINE 2mg / ml will be made once the articular surfaces are prepared to receive the prosthesis, at the level of the posterior capsule. The second injection of 50mL of ROPIVACAINE 2mg / ml will be performed once the total knee prosthesis is installed, in the medial and lateral ligaments. Finally, the last injection will also include 50mL of ROPIVACAINE 2mg / ml and will be made in the edges of the incision at the time of closure.
Study: NCT01780844
Drug: ASKP1240
Approvals — FDA: no, EMA: no, PMDA: no
Description: intravenous infusion
Study: NCT00479570
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Study: NCT02263326
Drug: Continue current antiretroviral regimen
Normalized name: Anacin Aspirin Regimen
Approvals — FDA: no, EMA: no, PMDA: no
Description: Continue current DHHS recommended or alternative three-drug antiretroviral regimen
Study: NCT00368745
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: GAD subjects on stable dose of alprazolam will be randomized to double-blind placebo matching assessments and study medication titration as detailed under the pregabalin arm description. Subjects successful in discontinuation of alprazolam while treated with placebo will continue to be maintained on placebo for 6 weeks and assessed weekly for ability to remain in the study.
Study: NCT01212887
Drug: cyclophosphamide
Normalized name: Cyclophosphamide
DrugBank: Cyclophosphamide (DB00531)
Approvals — FDA: yes, EMA: no, PMDA: yes
Study: NCT01722526
Drug: Recombinant human acid sphingomyelinase
Approvals — FDA: no, EMA: no, PMDA: no
Description: Administered intravenously every 2 weeks for 26 weeks
Study: NCT00506168
Drug: Irinotecan, Capecitabine
Approvals — FDA: no, EMA: no, PMDA: no
Study: NCT03691337
Drug: Marcaine 0.25 % Injectable Solution
Normalized name: Marcaine 0.25 % Injectable Solution
Approvals — FDA: no, EMA: no, PMDA: no
Description: Fascia iliaca block with volume 0.11 mL x subject height
Study: NCT03691337
Drug: Marcaine 0.25 % Injectable Solution
Normalized name: Marcaine 0.25 % Injectable Solution
Approvals — FDA: no, EMA: no, PMDA: no
Description: Fascia iliaca block with volume 0.22 mL x subject height
Study: NCT01308814
Drug: Estradiol
Normalized name: Estradiol
DrugBank: Estradiol acetate (DB13952)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: Transdermal 17β-estradiol (100 ug/day) for 12 months, administered as patches to be worn continuously and replaced once a week. Also, every 2 months, oral micronized progesterone (200 mg/day x 12 days) will be administered.
Study: NCT01308814
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: Placebo patches for 12 months, to be worn continuously and replaced once a week. Also, placebo pills will be administered for 12 days every 2 months.
Study: NCT00933608
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: participants will be asked to take 2 tablets per day to match active drug
Study: NCT02331589
Drug: Placebo (for KRG)
Approvals — FDA: no, EMA: no, PMDA: no
Description: Placebos with same shape and size were manufactured and at Korea Ginseng Corporation
Study: NCT02033629
Drug: Ce 1 ng/ml
Approvals — FDA: no, EMA: no, PMDA: no
Description: TCI Remifentanil Ce 1 ng/ml
Study: NCT02033629
Drug: Ce 2 ng/ml
Approvals — FDA: no, EMA: no, PMDA: no
Description: TCI Remifentanil Ce 2 ng/ml
Study: NCT02033629
Drug: Ce 3 ng/ml
Approvals — FDA: no, EMA: no, PMDA: no
Description: TCI Remifentanil Ce 3 ng/ml
Study: NCT01716039
Drug: MTX 12.5
Approvals — FDA: no, EMA: no, PMDA: no
Description: once weekly oral dosing with MTX 12.5 mg (n=40) two weeks prior to the initiation of adalimumab. Randomization will be stratified by disease activity (modified Mayo Score ≤9 or \>9).~Subjects will receive 18 weekly doses of MTX in addition to doses of adalimumab
Study: NCT04491682
Drug: Rosuvastatin
Normalized name: Rosuvastatin
DrugBank: Rosuvastatin (DB01098)
Approvals — FDA: yes, EMA: no, PMDA: yes
Description: At a dosage of 10 mg/day
Study: NCT04510987
Drug: BAY2433334 single dose in treatment groups 1-4 and 6 as well as on the dialysis free day of treatment 5
Approvals — FDA: no, EMA: no, PMDA: no
Description: Tablet, oral
Study: NCT01882556
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Study: NCT01964157
Drug: LDK378
Approvals — FDA: no, EMA: no, PMDA: no
Description: LDK378 750mg oral administration and continuously (28-day treatment schedule as one treatment cycle)
Study: NCT02483923
Drug: intravenous PCA only
Normalized name: lauryl PCA
Approvals — FDA: no, EMA: no, PMDA: no
Description: same dose of intravenous patient controlled analgesia (Basal rate 0ml/hr, 0.5mcg/kg of fentanyl, lock-out time 10minutes) is connected to patient only.
Study: NCT03608241
Drug: Ethinyl estradiol (EE) and levonogestrel (LN)
Normalized name: estradiol / ethinyl estradiol / levonorgestrel
Approvals — FDA: no, EMA: no, PMDA: no
Description: Single dose of Oral tablet containing 30 ug EE and 150 ug of LN
Study: NCT00669825
Drug: ALV003
Approvals — FDA: no, EMA: no, PMDA: no
Description: Doses via intragastric tube at dosages of either 100 mg, 300 mg, 900 mg, or 1800 mg
Study: NCT00669825
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: Placebo to be administered via intragastric tube
Study: NCT02482298
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: 10 mg ticagrelor placebo + 45 mg ticagrelor placebo. Drugs taken orally, twice a day (morning and evening at least 12 hours apart) from randomization until the end of treatment
Study: NCT01685242
Drug: AC-170 0.24%
Approvals — FDA: no, EMA: no, PMDA: no
Description: 1 drop in each eye at 2 separate times during a 14 day period
Study: NCT01685242
Drug: AC-170 0%
Approvals — FDA: no, EMA: no, PMDA: no
Description: 1 drop in each eye at 2 separate times during a 14 day period
Study: NCT00812396
Drug: Comparator: low dose testosterone
Approvals — FDA: no, EMA: no, PMDA: no
Description: Subjects will receive two muscle biopsies, the first at baseline, and the second a week after a single intramuscular dose of 200 mg (0.8 mL) testosterone.
Study: NCT00812396
Drug: Comparator: high dose testosterone
Approvals — FDA: no, EMA: no, PMDA: no
Description: Subjects will receive two muscle biopsies, the first at baseline, and the second a week after a single intramuscular dose of 600 mg (2.4 mL) testosterone.
Study: NCT00812396
Drug: Comparator: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: Subjects will receive two muscle biopsies, the first at baseline, and the second a week after a single intramuscular dose of 0.8 mL placebo saline solution.
Study: NCT03625778
Drug: MEDI0382
Approvals — FDA: no, EMA: no, PMDA: no
Description: MEDI0382 will be administered subcutaneously daily according to the MEDI0382 cohorts.
Study: NCT03625778
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: Placebo will be administered subcutaneously daily according to the Placebo cohorts.
Study: NCT00234663
Drug: PTC124
Approvals — FDA: no, EMA: no, PMDA: no
Study: NCT00811083
Drug: DMSA - dimercaptosuccinic acid
Normalized name: Dimercaptosuccinic acid
DrugBank: Dimercaptosuccinic acid (DB14089)
Approvals — FDA: no, EMA: no, PMDA: no
Description: dose of 10 mg/kg bodyweight 3 doses/day, for 3 days, followed by 11 days off
Study: NCT00106119
Drug: Liothyronine and Levothyroxine
Normalized name: LEVOTHYROXINE/LIOTHYRONINE
Approvals — FDA: no, EMA: no, PMDA: no
Description: Hypothyroid patients are treated with Liothyronine and Levothyroxine in 2 crossover, randomized phases
Study: NCT02923830
Drug: Saline-only catheter flush
Normalized name: T8 Keto Flush
Approvals — FDA: no, EMA: no, PMDA: no
Description: The intervention group will have their port catheters flushed with saline only.
Study: NCT01188551
Drug: Fentanyl
Normalized name: Fentanyl
DrugBank: Fentanyl (DB00813)
Approvals — FDA: yes, EMA: no, PMDA: yes
Description: fentanyl (2 µg/kg) will be administered intranasally
Study: NCT01595594
Drug: Systemic Doxycycline and Sham aPDT
Normalized name: Doxycycline
DrugBank: Doxycycline (DB00254)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: It will be prescribed a protocol of 100mg/day of Systemic Doxycycline for 14 days
Study: NCT01595594
Drug: aPDT + Doxycycline Placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: The aPDT protocol will consist in 5 applications on the experimental time 0, 1, 5, 7 and 14 days.
Study: NCT00865839
Drug: CLUCOPHAGE® XR 500 mg tablets, single dose
Approvals — FDA: no, EMA: no, PMDA: no
Description: B: Active comparator Subjects received Bristol-Myers Squibb Company formulated products under fasting conditions
Study: NCT01198509
Drug: doxycycline
Normalized name: Doxycycline
DrugBank: Doxycycline (DB00254)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: doxycycline - 100 mg twice per day, for 2 months
Study: NCT04714996
Drug: ES-481
Approvals — FDA: no, EMA: no, PMDA: no
Description: Treatment Period Week 1 - 25 mg qd, Week 2 - 25 mg bid, Week 3 - 50 mg bid, Week 4 - 75 mg bid.~Step-down and Washout Period Day 1 - 125 mg, Day 2 - 100 mg, Day 3 - 75 mg, Day 4 - 50 mg, Day 5 - 50 mg, Day 6 - 25 mg, Day 7 - 25 mg, Days 8 to 14 - 0 mg
Study: NCT04714996
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: Placebo on Week 1, Week 2, Week 3 and Week 4
Study: NCT04714996
Drug: Open-Label Extension Study
Normalized name: BOTTLE OPENER
Approvals — FDA: no, EMA: no, PMDA: no
Description: Dosing will be at the discretion of the Investigator with a minimum dose of 25 mg/day (25 mg qd) to a maximum dose of 150 mg/day (75 mg bid).
Study: NCT00089349
Drug: methotrexate
Normalized name: Methotrexate
DrugBank: Methotrexate (DB00563)
Approvals — FDA: yes, EMA: no, PMDA: yes
Description: Given IV
Study: NCT00089349
Drug: mercaptopurine
Normalized name: Mercaptopurine
DrugBank: Mercaptopurine (DB01033)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: Given PO
Study: NCT00589316
Drug: Cyclophosphamide
Normalized name: Cyclophosphamide
DrugBank: Cyclophosphamide (DB00531)
Approvals — FDA: yes, EMA: no, PMDA: yes
Description: Given IV
Study: NCT01073852
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: Placebo pill, 1 pill orally twice daily for 9 weeks.
Study: NCT02803307
Drug: TLC599
Approvals — FDA: no, EMA: no, PMDA: no
Description: Single dose via intra-articular injection
Study: NCT00799578
Drug: Cysteamine
Normalized name: Cysteamine
DrugBank: Cysteamine (DB00847)
Approvals — FDA: no, EMA: no, PMDA: no
Description: Drug is in enteric-coated capsule form. The dosage will begin at 1g/m-squared body surface area with a maximum dose of 1000mg twice daily. Treatment period is 3-6 months.
Study: NCT00499746
Drug: placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: oral dose, once per day
Study: NCT00590577
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: Placebo i.m. Days 1, 8, 36, 64
Study: NCT00790478
Drug: Melatonin
Normalized name: Melatonin
DrugBank: Melatonin (DB01065)
Approvals — FDA: yes, EMA: no, PMDA: yes
Description: Study Pill (5 mg/d) taken once daily, preferably an hour before bedtime, for 12 weeks.
Study: NCT00265031
Drug: Cyclophosphamide
Normalized name: Cyclophosphamide
DrugBank: Cyclophosphamide (DB00531)
Approvals — FDA: yes, EMA: no, PMDA: yes
Study: NCT01436656
Drug: LGX818
Approvals — FDA: no, EMA: no, PMDA: no
Study: NCT01583816
Drug: placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: topical application
Study: NCT03403530
Drug: IgM rich Immunoglobin
Normalized name: immunoglobulin A
Approvals — FDA: no, EMA: no, PMDA: no
Description: the 'IgM rich immunoglobn' is the normal human immunoglobin containing Human plasma protein 50mg/ml of which immunoglobin is atleast 95% Immunoglobin M (IgM) 6mg Immunoglobin A (IgA) 6mg Immunoglobin G (IgG) 38mg
Study: NCT01149005
Drug: novorapid / humalog short acting insulin
Approvals — FDA: no, EMA: no, PMDA: no
Description: 1-4 units will be injected Subcutaneously (SC), before every main meal.
Study: NCT00924612
Drug: Oral testosterone undecanoate (containing 300 mg T)
Normalized name: Testosterone Undecanoate
DrugBank: Testosterone undecanoate (DB13946)
Approvals — FDA: yes, EMA: no, PMDA: no
Study: NCT03357796
Drug: LY03005
Approvals — FDA: no, EMA: no, PMDA: no
Description: 80 mg, oral tablets, single dose
Study: NCT03483779
Drug: placebo pills
Normalized name: placebo Pill
Approvals — FDA: no, EMA: no, PMDA: no
Description: Each N-of-1 trial will consist of 6 treatment periods, of which 2 treatment periods are in one group, including 8 weeks of placebo treatment and 8 weeks of ginkgo biloba pills.
Study: NCT02342691
Drug: Placebo oral rinse
Approvals — FDA: no, EMA: no, PMDA: no
Description: The placebo preparation will consist of formulated oral rinse without BLXA4-ME and will be identical to the test rinse in color, appearance and taste
Study: NCT02214888
Drug: BIRB 796 BS, low dose
Approvals — FDA: no, EMA: no, PMDA: no
Study: NCT02214888
Drug: BIRB 796 BS, high dose
Approvals — FDA: no, EMA: no, PMDA: no
Study: NCT02214888
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Study: NCT01869036
Drug: caudal anesthesia
Normalized name: Gelato Anesthetic
Approvals — FDA: no, EMA: no, PMDA: no
Description: Standard caudal anesthesia (Marcaine 2mg/kg)
Study: NCT01156025
Drug: placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: 1 drop 10 times daily at D0 and D1 and 1 drop 5 times daily from D2 to D9 + additionnal treatment (Hyabak® eye drops: 5 times daily from D10 to D30)
Study: NCT00052390
Drug: doxorubicin hydrochloride
Normalized name: Doxorubicin Hydrochloride
DrugBank: Doxorubicin (DB00997)
Approvals — FDA: yes, EMA: no, PMDA: no
Study: NCT00834600
Drug: olmesartan, hydrochlorothiazide, amlodipine
Approvals — FDA: no, EMA: no, PMDA: no
Description: hydrochlorothiazide (HCTZ) 25mg OD, increased to 50 mg OD at 3 weeks. Olmesartan 20 mg OD, to be increased to 40 mg at 3 weeks. Amlodipine 5 mg, may be added at 6 weeks, if BP \>140 mmHg
Study: NCT00834600
Drug: hydrochlorothiazide (HCTZ) or olmesartan
Normalized name: hydrochlorothiazide / olmesartan
Approvals — FDA: no, EMA: no, PMDA: no
Description: HCTZ 25 mg, increasing to 50 mg at 3-4 weeks or Olmesartan 20 mg, increasing to 40 mg at 3-4 weeks. If blood pressure \>140/90 mmHg at 6 weeks, amlodipine 5 mg may be added
Study: NCT01271907
Drug: cyclophosphamide
Normalized name: Cyclophosphamide
DrugBank: Cyclophosphamide (DB00531)
Approvals — FDA: yes, EMA: no, PMDA: yes
Description: Cyclophosphamide 60 mg/kg intravenous (IV) x 2 days
Study: NCT04249297
Drug: Duphaston® (Dydrogesteron)
Approvals — FDA: no, EMA: no, PMDA: no
Description: No intervention. Description of routine practice only. Prescribed Duphaston® according local marketing authorization and international and Russian In-Vitro Fertilization guidelines for luteal phase support as part of an Assisted Reproductive Technology (1 tablet 3 times a day starting at the day of oocyte retrieval).
Study: NCT04224103
Drug: Inhaled nitric oxide
Normalized name: nitric oxide Inhalant Product
Approvals — FDA: no, EMA: no, PMDA: no
Description: Stage 1: Patients in whom VA ECMO is being initiated will be invited to participate. Hemodynamic, echocardiographic, and biochemical parameters will be measured immediately prior to iNO administration, and thirty minutes after initiation. After six hours, hemodynamic, echocardiographic, and biochemical parameters will be re-assessed after which iNO will be weaned. All parameters will be re-evaluated 30 minutes after iNO discontinuation.~Stage 2: iNO will be re-initiated 30 minutes prior to the ECMO weaning trial. Hemodynamic, echocardiographic, and biochemical parameter will be recorded immediately prior to iNO administration and then at 30 minutes prior to the ECMO weaning trial. When ECMO weaning is unsuccessful, these parameters will be recorded immediately prior to re-initiation of full flow VA ECMO and 30 minutes thereafter. If successful, data will be collected after the wean and after iNO discontinuation.
Study: NCT02195700
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: Placebo tablets taken twice daily for 12 weeks.
Study: NCT03871972
Drug: Umbilical Cord Blood Unit
Normalized name: Bos taurus umbilical cord preparation
Approvals — FDA: no, EMA: no, PMDA: no
Description: 3 infusions of umbilical cord blood (UCB) unit (TNC \> 2.0ⅹ107cells/kg) each 4 months apart and take oral Sirolimus (1 mg/m2/day) for 7 days (from 3 days before UCB infusion until 3 days after UCB infusion)
Study: NCT02204046
Drug: BIWA 4
Normalized name: BREATHING CIRCUIT,BIWAZE COUGH,W/MOUTHPIECE,STANDARD
Approvals — FDA: no, EMA: no, PMDA: no
Study: NCT03353363
Drug: Placebos
Approvals — FDA: no, EMA: no, PMDA: no
Description: After patients receive their spinal anesthetic and as the Pfannenstiel incision is being closed, an equal volume (20ml, administered via two 10ml syringes) of normal saline will be infiltrated into the wound by the obstetrician team in a standardized fashion.
Study: NCT01681186
Drug: LY2940680 Capsule(s) (Reference)
Approvals — FDA: no, EMA: no, PMDA: no
Description: Administered orally as a capsule(s)
Study: NCT01681186
Drug: LY2940680 Tablet (Test)
Normalized name: mumps skin test antigen
Approvals — FDA: no, EMA: no, PMDA: no
Description: Administered orally as a tablet
Study: NCT01681186
Drug: Placebo Capsule(s)
Approvals — FDA: no, EMA: no, PMDA: no
Description: Administered orally as a capsule(s)
Study: NCT01895400
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: Take placebo drug 1T bid po medication for 8 weeks
Study: NCT02719691
Drug: MLN0128
Approvals — FDA: no, EMA: no, PMDA: no
Description: Participants will receive MLN0128 in the dose-escalation and the dose-expansion part of the study.
Study: NCT00263042
Drug: Placebo (for Rimonabant)
Approvals — FDA: no, EMA: no, PMDA: no
Description: Tablet, oral administration
Study: NCT00194077
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: subjects in phase 2 will be randomized to active abilify or placebo
Study: NCT00807586
Drug: Solumedrol
Approvals — FDA: no, EMA: no, PMDA: no
Description: 100mg, given once within 2 hours of the end of the ablation procedure
Study: NCT00807586
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: Normal saline (1.6 cc)
Study: NCT02008942
Drug: Enteric-coated aspirin caplets
Approvals — FDA: no, EMA: no, PMDA: no
Description: 325 mg aspirin; once per day for 10 days
Study: NCT02143856
Drug: 100 mg GLPG1205
Approvals — FDA: no, EMA: no, PMDA: no
Description: A single dose of 100 mg GLPG1205 administered as two capsules of 50 mg
Study: NCT01863069
Drug: (IM) AVONEX®
Approvals — FDA: no, EMA: no, PMDA: no
Study: NCT04379635
Drug: Placebos
Approvals — FDA: no, EMA: no, PMDA: no
Description: Placebo to match tislelizumab IV infusion
Study: NCT02047422
Drug: furosemid/spironolactone
Approvals — FDA: no, EMA: no, PMDA: no
Description: spironolactone (doubling previous spironoalctone dose or add 12.5mg BID if previous non-user)
Study: NCT02047422
Drug: metolazone/spironolactone
Approvals — FDA: no, EMA: no, PMDA: no
Description: no spironolactone (maintaining previous spironolactone dose or not add spironolactone if previous non-user)
Study: NCT00282087
Drug: gemcitabine, docetaxel, doxorubicin
Approvals — FDA: no, EMA: no, PMDA: no
Description: Cycles = 28 days
Study: NCT00971581
Drug: FDC KETOPROFEN+OMEPRAZOLE
Normalized name: Ketoprofen
DrugBank: Ketoprofen (DB01009)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: Ketoprofen + Omeprazole FDC once daily for 4 weeks
Study: NCT04560816
Drug: ALXN1840
Approvals — FDA: no, EMA: no, PMDA: no
Description: ALXN1840 (120 milligrams) will be administered orally (supratherapeutic dose).
Study: NCT04560816
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: Placebo will be administered orally.
Study: NCT04624867
Drug: HP-1050 Patch
Normalized name: HP 502
Approvals — FDA: no, EMA: no, PMDA: no
Description: Both articles, HP-1050 and XULANE patch, will be applied simultaneously on the back of each subject.
Study: NCT02277691
Drug: HCTZ 12.5 mg tablet
Approvals — FDA: no, EMA: no, PMDA: no
Description: HCTZ tablets
Study: NCT04396548
Drug: Inert tablet containing sugar (placebo)
Normalized name: inert ingredients Oral Tablet
Approvals — FDA: no, EMA: no, PMDA: no
Description: : Patients will receive Inert tablet containing sugar (placebo) with small sips of water one hour before arrival in the operation room. All patients will be monitored in with noninvasive blood pressure as well as continuous electrocardiogram (ECG) and pulse oximetry (SpO2). Before placement of spinal anesthesia, all patients will receive an IV bolus of 10mL/kg of Lactated Ringer's . Spinal anesthesia (midline puncture) will be performed in sitting position by a staff anesthetist at L3-L4 or L4-L5 with a 25-gauge Withacre needle injecting 12.5 mg of hyperbaric 0.5% bupivacaine (2.5 mL) with 10μg fentanyl. After injection,the patients will be turned supine
Study: NCT03707990
Drug: NNC0165-1875
Approvals — FDA: no, EMA: no, PMDA: no
Description: Participants will receive a single dose of subcutaneous (s.c.) NNC0165-1875 injection. The planned doses of NNC0165-1875 are as following: cohort 1 and 7: 0.1 mg, cohort 2 and 8: 0.3 mg, cohort 3 and 9: 0.6 mg, cohort 4 and 10: 1.2 mg, cohort 5 and 11: 2.4 mg and cohort 6: 0.03 mg.
Study: NCT03707990
Drug: Placebo (NNC0165-1875)
Approvals — FDA: no, EMA: no, PMDA: no
Description: Participants will receive a single dose of s.c. placebo injection.
Study: NCT02966288
Drug: Oral NSAID
Normalized name: Ansaid Oral Product
Approvals — FDA: no, EMA: no, PMDA: no
Description: 800mg Motrin will be administered. (non-steroidal anti-inflammatory drug (NSAID))
Study: NCT00140907
Drug: Comparator: Placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: 25 mg of oral placebo once daily, with an up-titration to 50 mg placebo once daily in later visits if serum creatinine did not increase more than 25%. Patients take medication in the morning.
Study: NCT03623789
Drug: Normal saline
Normalized name: Normal Saline Flush
Approvals — FDA: no, EMA: no, PMDA: no
Description: Equivalent volume of saline injection before incision, followed by two boluses (1g TXA) three hours later and six hours later.
Study: NCT01147250
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: Pharmaceutical form: Sterile aqueous solution; Route of administration: Subcutaneous within 1-hour before breakfast.
Study: NCT03645096
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: Placebo capsule manufactured to mimic pregnenolone capsule.
Study: NCT00351767
Drug: placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: Topically applied
Study: NCT00631124
Drug: BAY86-4891 (Estradiol / Drospirenone)
Normalized name: drospirenone / estradiol
Approvals — FDA: no, EMA: no, PMDA: no
Description: Monophasic regimen containing estrogen and progestin 1 pre-treatment cycle, 3 treatment cycles
Study: NCT00631124
Drug: BAY86-4891 (Estradiol / Drospirenone)
Normalized name: drospirenone / estradiol
Approvals — FDA: no, EMA: no, PMDA: no
Description: Triphasic regimen containing estrogen and progestin 1 pre-treatment cycle, 3 treatment cycles