AIM-Harvard/TrialPanorama-filtered huggingface dataset:
Trial: NCT00684385
Drug: ZD1839
FDA approved: no
EMA approved: no
PMDA approved: no
Description: 250mg administered daily for patients with NSCLC and500mg daily for patients with H\&NC. Treatment dispensed to patients on Day 1 and every 12 weeks thereafter until the patient withdraws. Patients with NSCLC will take one tablet at each dose administration; patients with squamous cell H\&NC will take two tablets at each dose administration.
Trial: NCT05276856
Drug: Levothyroxine
RxNorm normalized name: Levothyroxine
DrugBank: Levothyroxine (DB00451)
FDA approved: yes
EMA approved: no
PMDA approved: yes
Description: Step 1:~* Reduce the dose of T4 therapy by 50% and recheck serum T4 after 2 weeks.~* If serum T4 is normal, go to step 2.~* If serum T4 drops to below normal then resume full T4 replacement (these patients will be considered as having withdrawal failure).~Step 2:~* Discontinue T4 therapy altogether and recheck serum TSH and T4 after 2 weeks.~* If serum T4 is normal, go to step 3.~* If serum T4 drops to below normal then resume full T4 replacement (these patients will be considered as having withdrawal failure).~Step 3:~* Recheck serum TSH and T4 after 8 weeks.~* If serum TSH and T4 levels are normal, these patients will be regarded as having successful T4 withdrawal.~* If T4 drops to below normal then resume full T4 replacement (these patients will be considered as having withdrawal failure).
Trial: NCT04641351
Drug: Zilretta Injectable Product or Placebo
RxNorm normalized name: Zilretta Injectable Product
FDA approved: no
EMA approved: no
PMDA approved: no
Description: The purpose of this intervention is to determine the use of extended release steroid knee injection (Zilretta) at the end of the surgery and its effects on your knee pain.In this study Zilretta will be injected intra-operatively for your arthroscopic partial meniscectomy (APM) surgery.Participants will have MRIs x-rays, and provide a sample of the synovial fluid from both knees at the beginning of surgery. This fluid is drained at the beginning of surgery and then usually discarded. Three samples each of blood and urine will be collected over the study period from each participant and sample of joint (synovial tissue) taken. Participants will be asked to answer questions about knee pain.
Trial: NCT05077423
Drug: CD33*CD3 BsAb
FDA approved: no
EMA approved: no
PMDA approved: no
Description: CD33xCD3 is a bispecific monoclonal antibody, which specifically targets CD33 on the AML blasts and CD3 on the T cells
Trial: NCT04820023
Drug: BBT-176
RxNorm normalized name: ethanol
DrugBank: Ethanol (DB00898)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: BBT-176 given orally alone
Trial: NCT06546527
Drug: [177Lu]Lu-PSMA-137
FDA approved: no
EMA approved: no
PMDA approved: no
Description: \[177Lu\]Lu-PSMA-137 500 MBq;50% optimal dosing;100% optimal dosing
Trial: NCT04602845
Drug: Fentanyl
RxNorm normalized name: Fentanyl
DrugBank: Fentanyl (DB00813)
FDA approved: yes
EMA approved: no
PMDA approved: yes
Description: 50ug Fentanyl intravenously
Trial: NCT04602845
Drug: Flurbiprofen
RxNorm normalized name: Flurbiprofen
DrugBank: Flurbiprofen (DB00712)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: 50mg Fentanyl intravenously
Trial: NCT06089603
Drug: Conventional pharmacological treatment
RxNorm normalized name: Hongo Killer Treatment
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Usual treatment of the patient
Trial: NCT05775250
Drug: giomer varnish
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Giomer varnish containing surface pre-reacted glass-ionomer (PRG) filler, will be administrated once.
Trial: NCT05809700
Drug: Freshly manufactured 35 kDa hyaluronan fragment
RxNorm normalized name: PALMITOYL FRAGMENT
FDA approved: no
EMA approved: no
PMDA approved: no
Description: This mixture of high molecular weight HA and hyaluronidase containing 100 mg of HA was locally injected at the pain point or where the nerve trunk innervates the pain point. Then, the pain scale (NPRS) was used to evaluate pain, and the pain relief of patients before and after treatment was recorded.~Each time, according to the amount of high molecular weight HA containing 100 mg HA and hyaluronidase mixture, the pain point area and pain point area of the nerve trunk innervation of the local multipoint injection. Then, the pain scale was used to evaluate pain, and the pain relief of patients before and after treatment was recorded.
Trial: NCT05332704
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: -Part A: Single ascending doses of placebo as a single IV dose (Cohort A1-A5).
Trial: NCT05332704
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: -Part B: Multiple doses of placebo as IV doses over a 4-week treatment period (Cohort B1 and B2).
Trial: NCT05332704
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: -Part C: Multiple doses of placebo as IV doses over a 4-week treatment period (Cohort C1 and C2).
Trial: NCT05913674
Drug: Modified early post-operative intraperitoneal chemotherapy (mEPIC)
RxNorm normalized name: Sx1 Medicated Post-Operative System KIT
FDA approved: no
EMA approved: no
PMDA approved: no
Description: On post-operative days 1 and 2, an abdominal reservoir is obtained by administering 1000 mL of plasmalyte with 50 mEq NaHCO3 via a Tenckhoff catheter. Participants will then receive an intraperitoneal fluorouracil bolus of 400 mg/m2 administered over 1 to 2 minutes followed by a continuous intraperitoneal fluorouracil infusion of 1200 mg/m2 over the next 24 hours. During the continuous intraperitoneal infusion of fluorouracil, 50 mg of folinic acid is administered intravenously.~After completion of mEPIC day 1, the perfusate is drained out before starting mEPIC day 2.
Trial: NCT06151483
Drug: Alpha-Agonist
FDA approved: no
EMA approved: no
PMDA approved: no
Description: The maternal systolic blood pressure was consistently maintained above 80% of the preoperative baseline value from the initiation of spinal anesthesia until fetal delivery.
Trial: NCT04767321
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Placebo gel will be applied topically to both nostrils by a qualified health professional. On each dosing occasion, a large drop of IMP will be applied into each nostril and distributed to cover the whole area of the nostril.
Trial: NCT06304857
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: tablet matching dapagliflozin 10 mg q.d
Trial: NCT04840511
Drug: control group
RxNorm normalized name: meningococcal group B vaccine Prefilled Syringe [Trumenba]
FDA approved: no
EMA approved: no
PMDA approved: no
Description: normal saline 0.15 ml bolus followed by 0.2 ml/kg/hr during operation and 0.1 ml/kg/hr during postoperative 24 hours
Trial: NCT05586373
Drug: medication 1
RxNorm normalized name: Acne Medication 10% Topical Gel
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Ibuprofen pills, identical to the intervention (dipyrone pills), will be administered every 6 hour for a maximum of five days
Trial: NCT05586373
Drug: medication 2
RxNorm normalized name: clearproof acne medication 2 % Topical Solution
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Dipyrone pills, identical to the intervention (ibuprofen pills), will be administered every 6 hour for a maximum of five days
Trial: NCT05606107
Drug: Glucocorticoid
RxNorm normalized name: Glucocorticoid
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Glucocorticoid
Trial: NCT05081219
Drug: Placebo (Insulin Diluent)
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Participants will administer placebo (insulin diluent) four times per day with an intranasal delivery device.
Trial: NCT05508347
Drug: Nituzumab/placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Test group: 3 cycles of induction chemotherapy combined with 9 times of nituzumab targeted therapy followed by 2-3 cycles of synchronous radiotherapy and chemotherapy combined with 7 times of nituzumab targeted therapy, a total of 16 times of nituzumab targeted therapy, equivalent to the whole course targeted therapy.~Control group: 3 cycles of induction chemotherapy combined with 9 times of placebo treatment followed by 2-3 cycles of concurrent chemoradiotherapy combined with 7 times of nituzumab targeted therapy, a total of 7 times of nituzumab targeted therapy, only targeted therapy during concurrent chemoradiotherapy
Trial: NCT04722666
Drug: MIJ821 Intravenous Injection
FDA approved: no
EMA approved: no
PMDA approved: no
Description: MIJ821 supplied in vials to be prepared on a mg/kg basis and to be administered for 40 minutes IV infusion on Day 1, Day 15 and Day 29
Trial: NCT04722666
Drug: Placebo Intravenous Injection
FDA approved: no
EMA approved: no
PMDA approved: no
Description: 40 minutes IV infusion of 0.9% sodium chloride solution on Day1, Day 15 and Day 29
Trial: NCT05849766
Drug: Ramipril Tritace®, Carvedilol Carvid®,and Spironolactone Aldactone®
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Ramipril 10 mg once daily, carvedilol 6.25 mg twice daily and spironolactone 25 once daily
Trial: NCT06640738
Drug: arm 2
RxNorm normalized name: Surgitube Arm 2 5/8x50"
FDA approved: no
EMA approved: no
PMDA approved: no
Description: This study tries to find the best drug concentration of Remifentanil, ALVOGEN® (2 mg/vial) in Uterine Fibroid Ablation. We have two arms. Arm 1 with Remifentanil, ALVOGEN® (2 mg/vial) 1.0 ng/mL, and arm 2 with Remifentanil, ALVOGEN® (2 mg/vial) 2.0 ng/mL, both given via a syringe infusion pump, Perfusor® Space \| B. Braun.
Trial: NCT05878704
Drug: GBT021601
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Oral
Trial: NCT04656561
Drug: ANX007
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Form: solution for injection; Route of Administration: IVT
Trial: NCT05337566
Drug: Azithromycin Pill + Cefuroxime
RxNorm normalized name: cefuroxime Pill
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Azithromycin 500 mg (2 tablets) per orally when arriving to the hospital before the operation and a single dose Cefuroxime 1.5g (when body mass index is under 30) or 3g (for those whose body mass index is 30 or more) in the operating theatre before the incision
Trial: NCT06565273
Drug: FBL-MTX
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Patients will be administered an initial dose of FBL-MTX by subcutaneous route. Subsequent doses will be titrated according to clinical response. Maximum dosage will be 2.5 mg, every 2 weeks.
Trial: NCT05121350
Drug: Arotinib hydrochloride capsule placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Placebo of Anlotinib hydrochloride capsule
Trial: NCT06467409
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: patient-controlled analgesia(PCA) administration
Trial: NCT06467409
Drug: LPM3480392 Injection
FDA approved: no
EMA approved: no
PMDA approved: no
Description: patient-controlled analgesia(PCA) administration
Trial: NCT06642077
Drug: LIDOFAST 40 mg/2 ml + 0.025 mg/2 ml
FDA approved: no
EMA approved: no
PMDA approved: no
Description: A total of 2 ampoules of LIDOFAST 40 mg/2 ml + 0.025 mg/2 ml were injected into the sternotomy incision site and around the chest tubes of 30 patients in the experimental group. The total number and dose of opioids, the total number and dose of analgesics used to relieve the pain of the patients in the 24 hours after the injection of 2 ampules of LIDOFAST 40 mg/2 ml + 0.025 mg/2 ml, and the total number and dose of analgesics were recorded, and the patients were interviewed face-to-face 24 hours later, and PoRI was recorded. No intervention was performed on 30 patients in the control group, and standard treatment and care continued to be applied to these patients.
Trial: NCT06645197
Drug: SNUG01
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Recombinant adeno-associated virus serotype 9 capsid containing human SG001 expression cassette
Trial: NCT04899687
Drug: Fluoxetine
RxNorm normalized name: Fluoxetine
DrugBank: Fluoxetine (DB00472)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: Fluoxetine 20mg (or previously prescribed dose) will be taken once daily by mouth for 8 weeks
Trial: NCT05432167
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Patients will take placebo tablets by mouth once daily.
Trial: NCT05040776
Drug: EP-7041 Injection
RxNorm normalized name: acetaminophen
DrugBank: Acetaminophen (DB00316)
FDA approved: no
EMA approved: no
PMDA approved: no
Description: EP-7041 infusion
Trial: NCT04942002
Drug: Methylprednisolone Acetate 40 MG/ML [Depo-Medrol]
RxNorm normalized name: methylPREDNISolone acetate 40 MG/ML [DEPO-Medrol]
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Retrobulbar injection performed by care provider
Trial: NCT04942002
Drug: Placebo Comparator: Standard treatment + placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Intravenous Methylprednisolone succinate (1 g daily for 5 days) + paraocular injection of 0.9% saline solution by care provider
Trial: NCT04991948
Drug: CYAD-101
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Allogeneic NKG2D-based CYAD-101 Chimeric antigen Receptor T-cells
Trial: NCT04991948
Drug: FOLFOX
FDA approved: no
EMA approved: no
PMDA approved: no
Description: 5-FU, leucovorin and oxaliplatin
Trial: NCT05157360
Drug: HAT
RxNorm normalized name: KHAT
FDA approved: no
EMA approved: no
PMDA approved: no
Description: hydrocortisone, ascorbic acid (vitamin C), and thiamine (vitamin B1); referred to as HAT
Trial: NCT05157360
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: normal saline solution
Trial: NCT05938608
Drug: Regimen 1 (Oral primaquine)
RxNorm normalized name: Anacin Aspirin Regimen Pill
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Primaquine 15 mg base orally once
Trial: NCT05938608
Drug: Regimen 2 (IV primaquine phosphate)
RxNorm normalized name: Anacin Aspirin Regimen Pill
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Primaquine 7.5 mg base in normal saline 500 mL infused over 30 minutes intravenously
Trial: NCT05938608
Drug: Regimen 3 (IV carboxyprimaquine)
RxNorm normalized name: Anacin Aspirin Regimen Pill
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Carboxyprimaquine 7.93 mg base in normal saline 500 mL infused over 30 minutes intravenously
Trial: NCT05294887
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Placebo
Trial: NCT04882228
Drug: Entelon Tab.150mg
FDA approved: no
EMA approved: no
PMDA approved: no
Description: twice daily for 8 weeks
Trial: NCT04882228
Drug: Venitol Tab.
FDA approved: no
EMA approved: no
PMDA approved: no
Description: twice daily for 8 weeks
Trial: NCT04882228
Drug: Placebo of Venitol Tab.
FDA approved: no
EMA approved: no
PMDA approved: no
Description: twice daily for 8 weeks (with Entelon Tab.150mg. It is for the masking.)
Trial: NCT04882228
Drug: Placebo of Entelon Tab.150mg
FDA approved: no
EMA approved: no
PMDA approved: no
Description: twice daily for 8 weeks(with Venitol Tab. It is for the masking.)
Trial: NCT04906694
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Diluent solution
Trial: NCT04696029
Drug: Difluoromethylornithine
RxNorm normalized name: α-difluoromethylornithine
DrugBank: Eflornithine (DB06243)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: DFMO (difluoromethylornithine is an inhibitor of ornithine decarboxylase (ODC) designated chemically as 2-(difluoromethyl)-DL-ornithine monohydrochloride monohydrate.~The dosage form to be used in this study is provided as a convex tablet containing 192 mg eflornithine (equivalent to 250 mg of eflornithine HCl, monohydrate). The tablets are packaged and sealed in opaque white HDPE bottles, and each bottle contains 100 tablets. The DMFO tablets are supplied by USWorldMeds (USWM).~The tablets are to be stored at room temperature (20-250C).
Trial: NCT06451588
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: The placebo treatment will be prepared based on the patients' fecal samples (autologous).
Trial: NCT04518137
Drug: ATG-008 30 mg, orally, QD, each 4 week (28-day) a cycle
FDA approved: no
EMA approved: no
PMDA approved: no
Description: 48 patients enrolled will be treated with 30mg QD of ATG-008, orally, each 4 week (28-day) a cycle
Trial: NCT06341894
Drug: Endocrine therapy
RxNorm normalized name: ENDOCRINE THERAPY
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Fulvestrant/AI
Trial: NCT05124730
Drug: Glucophage® XR 500 mg prolonged release tablets (Merck Serono Ltd, UK)
FDA approved: no
EMA approved: no
PMDA approved: no
Description: One tablet of Reference (R) Product was administered orally with 240 mL of water.
Trial: NCT05586776
Drug: Placebo Nasal Ointment
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Applied to each nostril twice daily for five days for the first two weeks after hospital discharge.
Trial: NCT06179537
Drug: BLU-5937
RxNorm normalized name: Blu-Kote
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Single and multiple doses assessment
Trial: NCT06172140
Drug: Ciprofol group
RxNorm normalized name: Streptococcus viridans group
FDA approved: no
EMA approved: no
PMDA approved: no
Description: All patients received 5 μ g of sufentanil 1 minute before intravenous infusion of ciprofol, followed by intravenous injection of ciprofol (0.4mg/kg). When the MOAA/S score is ≤ 1, vaginal disinfection begins. During the induction of sedation, the MOAA/S score is evaluated every 30 seconds. If the MOAA/S score remains above 1, a supplementary dose of 1/2 of the initial dose is injected within 10 seconds. During the maintenance phase, supplementary doses are given when there are signs of physical activity, eye opening, or speech. If more than 5 additional doses are required within 15 minutes, painless hysteroscopy is considered a failure, and propofol is immediately used to enhance sedation.
Trial: NCT05656040
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Normal saline administered subcutaneously
Trial: NCT04277247
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: 0.9% saline placebo injection
Trial: NCT05640427
Drug: normal saline
RxNorm normalized name: Normal Saline Flush
FDA approved: no
EMA approved: no
PMDA approved: no
Description: The same capacity of 0.9% normal saline was used in group C
Trial: NCT05511948
Drug: DBI-102
RxNorm normalized name: BAG,ENTERAL DRAIN SET ENFIT #DBISO-1000
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Topical application on dorsal hand and upper volar arm
Trial: NCT05511948
Drug: Vehicle gel
RxNorm normalized name: vehicle gel base no.61
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Inactive comparator
Trial: NCT06186609
Drug: PD-1 inhibitor 200mg per three to four weeks, for one year
FDA approved: no
EMA approved: no
PMDA approved: no
Description: PD-1 inhibitor delivered 200mg once before radiotherapy and 200mg every 3-4 weeks after radiotherapy for one year.~Radiotherapy:56-60Gy/28-30 fraction.
Trial: NCT05188989
Drug: TPN171H 2.5mg group
FDA approved: no
EMA approved: no
PMDA approved: no
Description: TPN171H 2.5mg taken orally on demand 0.5-4 hour prior to sexual intercourse
Trial: NCT05188989
Drug: TPN171H 5mg group
RxNorm normalized name: Streptococcus viridans group
FDA approved: no
EMA approved: no
PMDA approved: no
Description: TPN171H 5mg taken orally on demand 0.5-4 hour prior to sexual intercourse
Trial: NCT05188989
Drug: TPN171H 10mg group
RxNorm normalized name: Streptococcus viridans group
FDA approved: no
EMA approved: no
PMDA approved: no
Description: TPN171H 10mg taken orally on demand 0.5-4 hour prior to sexual intercourse
Trial: NCT05188989
Drug: Placebo group
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Placebo taken orally on demand 0.5-4 hour prior to sexual intercourse
Trial: NCT04648020
Drug: Placebo Mucoadhesive Buccal Tablet
RxNorm normalized name: placebo Oral Tablet
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Placebo
Trial: NCT05067335
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Subjects will receive Placebo in a specified sequence during the treatment Period.
Trial: NCT05309525
Drug: Lysteda 650 MG Oral Tablet
RxNorm normalized name: Lysteda 650 MG Oral Tablet
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Subjects will be given the therapeutic dose of tranexamic acid for menorrhagia, which is 1300 mg PO TID for up to 5 days during menstruation
Trial: NCT05849129
Drug: Ascorbic acid
RxNorm normalized name: Ascorbic Acid
DrugBank: Ascorbic acid (DB00126)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: High dose ascorbic acid delivered intravenously
Trial: NCT06563518
Drug: Meridol
FDA approved: no
EMA approved: no
PMDA approved: no
Description: toothpaste
Trial: NCT05819359
Drug: BIA 28-6156 10 mg
RxNorm normalized name: Oatmeal 10 mg in 1 mL TOPICAL CREAM [BIA Eczema Relief]
FDA approved: no
EMA approved: no
PMDA approved: no
Description: BIA 28-6156 10 mg, once daily, oral administration.
Trial: NCT05819359
Drug: BIA 28-6156 60 mg
RxNorm normalized name: Oatmeal 10 mg in 1 mL TOPICAL CREAM [BIA Eczema Relief]
FDA approved: no
EMA approved: no
PMDA approved: no
Description: BIA 28-6156 60 mg, once daily, oral administration.
Trial: NCT05819359
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Placebo, once daily, oral administration.
Trial: NCT04747301
Drug: Dinoprostone 10mg (Propess)
RxNorm normalized name: Dinoprostone
DrugBank: Dinoprostone (DB00917)
FDA approved: yes
EMA approved: no
PMDA approved: yes
Description: Propess® 10mg Vaginal delivery system (Ferring Controlled Therapeutics Ltd., 1 Redwood Place, Peel Park Campus, East Kilbride, Glasgow, G74 5PB, UK) is a vaginal insert containing 10mg of dinoprostone in a timed-release formulation (the medication is released at 0.3 mg/hour).~A Propess vaginal system is inserted by a research doctors. As in the catheter procedure, Fetal Heart Rate is monitored 30min before and 2 hours after placement. Cardiotocograph and vaginal examination will be performed every 6 hours. The vaginal system is placed for a maximum of 24 hours.~If it is expelled in the first 12 hours and the patient has no contractions or still shows an unfavorable cervix, another vaginal system is placed for a maximum of another 24 hours.~The patients will be examined in case of extreme pain or membranes ruptured.
Trial: NCT06154590
Drug: Method(s)2 Attribution,
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Intervention(s): -Attribution defines the relationship between the adverse event and the investigational agent(s)/intervention. Assign the appropriate category code of attribution Codes: 1-5, Descriptor, Unrelated, Unlikely, Possible, Probable, Definite.~Definitions: Use Adverse Events. Dose Units- Indicate the dosing units (e.g., mg) administered to the patient TAC. Reporting Group: Participant without Disease, Description: Absence of Disease as defined by negative reference test.~Dosage Form: 1mg Anastrozole, given once daily. 20 mg NOLVADEX (tamoxifen citrate) tablet given once daily, (the 20 mg NOLVADEX (tamoxifen citrate) tablet is bioequivalent to the 10 mg NOLVADEX. (tamoxifen citrate) tablets.)