AIM-Harvard/TrialPanorama-filtered huggingface dataset:
Study NCT05317182 — intervention group
Intervention type: OTHER
Group type: ACTIVE_COMPARATOR
Intervention: Occlusal Splints Analogic-Analogic
Description: Take a conventional impression to the patient and conventional fabrication of the splint.
Study NCT05317182 — intervention group
Intervention type: OTHER
Group type: ACTIVE_COMPARATOR
Intervention: Occlusal Splints Analogic-Digital
Description: Take a conventional impression to the patient and digital fabrication of the splint.
Study NCT05317182 — intervention group
Intervention type: OTHER
Group type: ACTIVE_COMPARATOR
Intervention: Occlusal Splints Digital-Digital
Description: Take a digital impression to the patient and digital fabrication of the splint.
Study NCT05131698 — intervention group
Intervention type: COMBINATION_PRODUCT
Group type: EXPERIMENTAL
Intervention: Tislelizumab and Lenvatinib
Description: TACE therapy: For transarterial infusion chemotherapy before or after TACE embolization, each drug will generally be diluted with 0.9% sodium chloride solution or 5% dextrose solution 150-250 mL and injected slowly into the target artery for ≥20 min. Subsequent TACE therapy will be administered on an as-needed basis as assessed by the clinician, with each treatment interval exceeding 6 weeks and no more than 6 treatments in total.~Lenvatinib: The starting dose of lenvatinib will depend on the patient's baseline weight: if baseline weight ≥ 60 kg, patients will receive 12 mg of lenvatinib administered once daily; if baseline weight \< 60 kg, patients will receive 8 mg of lenvatinib once daily. TACE therapy will be given 3 days apart.~Tirelizumab: Tirelizumab 200 mg , intravenous infusion on the same day as the first dose of lenvatinib, once every three weeks.~Translated with www.DeepL.com/Translator (free version)
Study NCT05415839 — intervention group
Intervention type: DEVICE
Group type: ACTIVE_COMPARATOR
Intervention: Laser
Description: Laser
Study NCT05907629 — intervention group
Intervention type: OTHER
Intervention: MRI
Description: Additional MRI to the CAPTIVA study at baseline and 12 months follow-up
Study NCT04709770 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: 2-liters polyethylene glycol with citrate and simethicone
Description: Low-volume polyethylene glycol-based bowel cleansing agent for colonoscopy.
Study NCT04709770 — intervention group
Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: 4-liters polyethylene glycol with simethicone
Description: High-volume polyethylene glycol-based bowel cleansing agent for colonoscopy.
Study NCT04709770 — intervention group
Intervention type: DIETARY_SUPPLEMENT
Group type: ACTIVE_COMPARATOR
Intervention: Low-residue diet
Description: Diet before colonoscopy.
Study NCT04709770 — intervention group
Intervention type: DIETARY_SUPPLEMENT
Group type: EXPERIMENTAL
Intervention: Low-residue diet
Description: Diet before colonoscopy.
Study NCT06295250 — intervention group
Intervention type: BEHAVIORAL
Group type: ACTIVE_COMPARATOR
Intervention: Manualized Group Based Psychotherapy
Description: Manualized Group Based Psychotherapy. Adapted from the World Health Organization (WHO) Problem Management Plus (PM+) intervention, this intervention includes behavioral activation, enhancing social support, and problem management.
Study NCT06295250 — intervention group
Intervention type: BEHAVIORAL
Group type: EXPERIMENTAL
Intervention: Manualized Group Based Psychotherapy
Description: Manualized Group Based Psychotherapy. Adapted from the World Health Organization (WHO) Problem Management Plus (PM+) intervention, this intervention includes behavioral activation, enhancing social support, and problem management.
Study NCT06295250 — intervention group
Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: Poverty Alleviation
Description: This intervention includes Asset transfer, skill transfer, financial literacy education, stipend, savings accounts, veterinary support, feed, and agricultural training
Study NCT06218693 — intervention group
Intervention type: BEHAVIORAL
Group type: EXPERIMENTAL
Intervention: VIA Family
Description: A family-based, multi-component, individual-tailored intervention based on case-management.
Study NCT06218693 — intervention group
Intervention type: BEHAVIORAL
Group type: ACTIVE_COMPARATOR
Intervention: Treatment As Usual (TAU)
Description: care as usual
Study NCT05006911 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Pilocarpine, brimonidine, oxymetazoline, hyaluronic acid, bromfenac (PBOHB) compound
Description: To determine the safety and efficacy of a PBOHB compound in near vision of presbyopic patients.
Study NCT05742594 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Lazertinib
Description: Lazertinib will be administered orally.
Study NCT05395715 — intervention group
Intervention type: PROCEDURE
Group type: EXPERIMENTAL
Intervention: Electrical stimulation
Description: Patients with cubital tunnel syndrome will receive either surgery and sham stimulation, or conditioning electrical stimulation 7 days prior to surgery
Study NCT05395715 — intervention group
Intervention type: PROCEDURE
Group type: ACTIVE_COMPARATOR
Intervention: Electrical stimulation
Description: Patients with cubital tunnel syndrome will receive either surgery and sham stimulation, or conditioning electrical stimulation 7 days prior to surgery
Study NCT05416502 — intervention group
Intervention type: PROCEDURE
Intervention: Ultrasound
Description: Enrolled patients underwent ultrasound scan of kidneys, ureters, and the bladder.
Study NCT03660540 — intervention group
Intervention type: DIETARY_SUPPLEMENT
Group type: EXPERIMENTAL
Intervention: Juven
Description: Nutritional supplement (Juven) will be consumed daily per manufacturer recommendations.
Study NCT04819568 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Terlipressin
Description: Terlipressin Bolus Max dose 2 mg/24 hr.i.e 0.5 mg qid
Study NCT04819568 — intervention group
Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Terlipressin
Description: Terlipressin Bolus Max dose 2 mg/24 hr.i.e 0.5 mg qid
Study NCT04819568 — intervention group
Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: Standard of Care
Description: Standard of Care
Study NCT04819568 — intervention group
Intervention type: OTHER
Group type: ACTIVE_COMPARATOR
Intervention: Standard of Care
Description: Standard of Care
Study NCT04832893 — intervention group
Intervention type: DIAGNOSTIC_TEST
Group type: ACTIVE_COMPARATOR
Intervention: steady intensity aerobic test of 30 minutes long
Description: the use of different type of masks during an aerobic exercise
Study NCT04832893 — intervention group
Intervention type: DIAGNOSTIC_TEST
Group type: SHAM_COMPARATOR
Intervention: steady intensity aerobic test of 30 minutes long
Description: the use of different type of masks during an aerobic exercise
Study NCT04360096 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: ZYESAMI™ (aviptadil acetate)
Description: Inhaled ZYESAMI™ (aviptadil acetate) 100μg 3x daily by mesh nebulizer
Study NCT04360096 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Placebo
Description: Normal Saline Inhalation
Study NCT04360096 — intervention group
Intervention type: DEVICE
Group type: EXPERIMENTAL
Intervention: Nebulized administration of ZYESAMI™ or Placebo
Description: Use of 510(k) cleared mesh nebulizer to deliver investigational product
Study NCT05144490 — intervention group
Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: Exercise
Description: A single session of bodyweight exercise
Study NCT05151666 — intervention group
Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: Sunny Health & Fitness Magnetic Mini Exercise Pedal Cycle - SF-B020026 Gray
Description: The intervention will be that the patient cycles in a sitting position within the first 2 hours of hemodialysis treatment for 15-60 minutes/as tolerated, either intermittent/continuous duration. - Graded duration will increase every 2 weeks. This will be supervised by a dialysis nurse as per the schedule of study assessments.
Study NCT05030597 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: 68Ga-DOTA-FAPI
Description: Intravenous access is pre-established. Quality control is carried out to confirm the radiochemical purity of 68Ga-DOTA-FAPI by HPLC. Intravenous administration of 68Ga-DOTA-FAPI according to 1.85-3.7 MBq/kg body weight (0.05-0.1 mCi/kg), rinsed with 0.9% saline, and hydrated after drinking more water.
Study NCT05030597 — intervention group
Intervention type: DEVICE
Group type: EXPERIMENTAL
Intervention: PET/CT
Description: Each subject undergoes PET/CT imaging within 20-30 minutes after injection.
Study NCT04836091 — intervention group
Intervention type: BEHAVIORAL
Group type: EXPERIMENTAL
Intervention: Waitlist
Description: From day 31 to day 60 (ie., during month 2) of the trial, participants in the waitlist arm will be granted access and instructed to use the OurPlan program as directed. The OurPlan program includes 4 modules covering topics of communication, HIV/STI prevention, HIV/STI statistics, and stigma / discrimination. Each module contains content, questions, and an activity for the participant and couple to complete. OurPlan also includes a resource locator using GPS-capabilities to allow participants to find sexual health resources, as well as a calendar and reminder system. One goal of OurPlan is to help both partners of the couple create and use a risk-reduction plan of evidence-based prevention strategies over time. Answers provided during the assessments will help determine whether participants/couples created a risk-reduction plan and used evidence-based strategies over time, including changes in their own and partner-related attitudes toward these strategies.
Study NCT04836091 — intervention group
Intervention type: BEHAVIORAL
Group type: EXPERIMENTAL
Intervention: Intervention
Description: From day 1 to day 60 (ie., entire 2 month duration) of the trial, participants in the intervention arm will be granted access and instructed to use the OurPlan program as directed. The OurPlan program includes 4 modules covering topics of communication, HIV/STI prevention, HIV/STI statistics, and stigma / discrimination. Each module contains content, questions, and an activity for the participant and couple to complete. OurPlan also includes a resource locator using GPS-capabilities to allow participants to find sexual health resources, as well as a calendar and reminder system. One goal of OurPlan is to help both partners of the couple create and use a risk-reduction plan of evidence-based prevention strategies over time. Answers provided during the assessments will help determine whether participants/couples created a risk-reduction plan and used evidence-based strategies over time, including changes in their own and partner-related attitudes toward these strategies.
Study NCT04978480 — intervention group
Intervention type: OTHER
Intervention: no intervention
Description: There is no intervention. We are only collecting standard of care data.
Study NCT05868200 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Capitano zenzero toothpaste
Description: Filming toothpate formulation, enriched with 3%ginger as active ingredient and Zinc coco sulfate as surfactant, cleansing and emulsifying agent.~Subjectswill then be given the test intervention, Capitano zenzero toothpaste, and will be asked to brush with it for two minute twice per day and will be instructed torefrain from eating and drinking for 30 min after brushing. participants will be received a toothbrush with medium-hardness bristles .the bass technique method of brushing by was comprehensively explained to all participants.. Next, the participants will be re-evaluated after 3 months .
Study NCT06228443 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Leflunomide 20 mg Film-coated Tablet
Description: Leflunomide 20 mg Film-coated Tablet (Test Drug)
Study NCT06228443 — intervention group
Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: ARAVA® 20 mg Film-coated Tablet
Description: ARAVA® 20 mg Tablets (Reference Drug)
Study NCT05868200 — intervention group
Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Colgate total toothpaste
Description: Subjects will then be given Colgate total toothpaste, as an active comparator, and will be asked to brush with it for two minutes twice per day and will be instructed to refrain from eating and drinking for 30 min after rinsing. participants will be received a toothbrush with medium-hardness bristles . participants will be received a toothbrush with medium-hardness bristles .the bass technique method of brushing by was comprehensively explained to all participants.. Next, the participants will be re-evaluated after 3 months .
Study NCT05256953 — intervention group
Intervention type: PROCEDURE
Group type: ACTIVE_COMPARATOR
Intervention: Erector spina plane block + general anesthesia
Description: Bilateral-injection ultrasound-guided bilateral erector spinae plane block~Pre-operatively, with the patient in the sitting position, 20ml 0.25% bupivacaine will be administered between the T9 spinous process and the erector spinae muscles with the guidance of an ultrasound probe placed on a parasagittal plane. The same procedure was applied bilaterally.~Intraoperative analgesia: After anesthesia induction tenoxicam 20 mg IV and 30 min. before the end of the surgery paracetamol (1gr) iv was applied.~Postoperative analgesia: IV-PCA: The requested dose will be 20µg/kg morphine, the lock-in time will be 6-10 minutes, the 4-hour limit will be 80% of the total calculated dose.~Rescue analgesia was provided with iv tramadol 30 mg boluses whenever the Visual analog scale pain score >3, (max doses 300 mg/day).
Study NCT05256953 — intervention group
Intervention type: PROCEDURE
Group type: ACTIVE_COMPARATOR
Intervention: Only general anesthesia
Description: Intraoperative analgesia: After anesthesia induction tenoxicam 20 mg IV and 30 min. before the end of the surgery paracetamol (1gr) iv was applied.~Postoperative analgesia: IV-PCA: The requested dose will be 20µg/kg morphine, the lock-in time will be 6-10 minutes, the 4-hour limit will be 80% of the total calculated dose.~Rescue analgesia was provided with iv tramadol 30 mg boluses whenever the Visual analog scale pain score >3, (max doses 300 mg/day).
Study NCT06439043 — intervention group
Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: EMDR Psychotherapy
Description: EMDR psychotherapy will be delivered in person by the psychotherapist to treat symptoms of Major Depressive Disorder, consisting of 12 weekly sessions.
Study NCT06007066 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: HSK16149 capsule
Description: Subjects will be given 40mg or 60mg of HSK16149 orally.
Study NCT06007066 — intervention group
Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Placebo
Description: Subjects will be given HSK16149 placebo orally.
Study NCT05234593 — intervention group
Intervention type: DIETARY_SUPPLEMENT
Group type: OTHER
Intervention: EmpowerPlus Lightning Sticks
Description: multinutrient supplement containing vitamins, minerals, amino acids and antioxidants taken one Stick daily by dissolving the powder on or under the tongue
Study NCT05068453 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Recombinant Oncolytic HSV-2 Therapeutic Injecta (Vero Cell) for Human Use (rHSV2hGM-CSF)
Description: OH2：less than 8mL/time，Q2W，i.t.；
Study NCT05068453 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Recombinant humanized anti-PD-1 monoclonal antibody for injection
Description: HX-008：200mg/time，Q3W，i.v.；
Study NCT05068453 — intervention group
Intervention type: RADIATION
Group type: EXPERIMENTAL
Intervention: RT
Description: 3 times radiation，totally 24-30 Gy for each lession.
Study NCT06344936 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: HRS-1780 tablets; Itraconazole capsules; Rifampicin capsules
Description: Treatment PartⅠ: Itraconazole capsule, 200mg QD, 7 times; HRS-1780 tablets, 10mg QD, twice Treatment PartⅡ: Rifampicin capsules, 600mg QD, 14 times; HRS-1780 tablets, 10mg QD, twice
Study NCT06439043 — intervention group
Intervention type: OTHER
Group type: ACTIVE_COMPARATOR
Intervention: Online EMDR Psychotherapy
Description: Online EMDR Psychotherapy will be delivered online by the psychotherapist to treat symptoms of Major Depressive Disorder, consisting of 12 weekly sessions.
Study NCT06648928 — intervention group
Intervention type: BEHAVIORAL
Group type: EXPERIMENTAL
Intervention: Clinician Supported PTSD Coach
Description: Combines self-managed PTSD Coach application with four 20-30 minute sessions delivered by a clinician. The app includes modules on learning about PTSD, self-assessment, symptom management, and finding support.
Study NCT05345938 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Mitoxantrone Hydrochloride Liposome
Description: Intravenous injection (IV), on day 1 of each 28-day cycle (q4w)
Study NCT04878289 — intervention group
Intervention type: BEHAVIORAL
Group type: EXPERIMENTAL
Intervention: TOTAL with Motivational Telemedicine Sessions
Description: Teaching Obesity Treatment Options to Adult Learners Educational Video with 3, 30 minute motivational sessions at 1 week, 6 months, and 12 months after viewing video
Study NCT04498468 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Sustained Release Dexamethasone, 0.4 mg
Description: dexamethasone 0.4mg lacrimal insert
Study NCT04498468 — intervention group
Intervention type: OTHER
Group type: SHAM_COMPARATOR
Intervention: E-Caprolactone-L-Lactide copolymer (PCL) punctal plug
Description: Control eye will receive a tear duct plug without the dexamethasone (EXTENDED WEAR SYNTHETIC ABSORBABLE PUNCTAL PLUG made of E-Caprolactone-L-Lactide copolymer (PCL). Absorbs in 60 to 180 days. Size 0.5mm which is comparable to the study treatment)
Study NCT05339204 — intervention group
Intervention type: PROCEDURE
Group type: ACTIVE_COMPARATOR
Intervention: allo-HSCT
Description: allo-HSCT from any type of donor
Study NCT05339204 — intervention group
Intervention type: PROCEDURE
Group type: EXPERIMENTAL
Intervention: allo-HSCT
Description: allo-HSCT from any type of donor
Study NCT05280236 — intervention group
Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Propofol TIVA
Description: Patients will receive propofol-based TIVA with propofol and remifentanil TCI (target controlled infusion)
Study NCT05280236 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Remimazolam TIVA
Description: Patients will receive remimazolam-based TIVA with remimazolam infusion and remifentanil TCI
Study NCT05009238 — intervention group
Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: lumbar stabilization exercises
Description: selected exercises will taught to participant and practiced 3 times per week for 6 weeks
Study NCT06450808 — intervention group
Intervention type: DIETARY_SUPPLEMENT
Group type: EXPERIMENTAL
Intervention: Dried Microalgae biomass
Description: The products to be tested are pestos enriched with different amounts of the microalgae Phaeodactylum tricornutum (3, 4 and 5%). After drying, the microalgae Phaeodactylum, which has already been used in two previous applications (application german ethic F-2020-001), is added to the pesto. Three different pestos will be produced and enriched with different amounts of the microalgae Phaeodactylum.
Study NCT04677023 — intervention group
Intervention type: OTHER
Group type: OTHER
Intervention: GrandioSO x-tra® bulk
Description: The prepared cavities will be restored with GrandioSO X-tra (VOCO, Cuxhaven, Germany) in layers that are a maximum of 4 mm thick then cured for 20 seconds using using Elipar™️ S10 LED curing light (3M ESPE, St Paul, MN, USA) with light intensity of 1200 mW/cm2.
Study NCT06648928 — intervention group
Intervention type: BEHAVIORAL
Group type: ACTIVE_COMPARATOR
Intervention: Self Managed PTSD Coach
Description: A widely available mobile application designed to help individuals manage PTSD symptoms available in English and Spanish.
Study NCT05453903 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Bleximenib
Description: Participants will receive bleximenib.
Study NCT04677023 — intervention group
Intervention type: OTHER
Group type: OTHER
Intervention: Admira fusion X--tra® bulk
Description: he prepared cavities will be restored with Admira fusion X-tra®️ bulk (VOCO, Cuxhaven, Germany) in layers that are a maximum of 4 mm thick then cured for 20 seconds using usingElipar™️ S10 LED curing light (3M ESPE, St Paul, MN, USA) with light intensity of 1200 mW/cm2.
Study NCT05453903 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Venetoclax (VEN)
Description: Participants will receive VEN.
Study NCT05453903 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Azacitidine (AZA)
Description: Participants will receive AZA.
Study NCT05453903 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Cytarabine
Description: Participants will receive cytarabine.
Study NCT05453903 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Daunorubicin or Idarubicin
Description: Participants will receive daunorubicin or idarubicin.
Study NCT05539924 — intervention group
Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Pregabalin 150mg gabapentin 400mg
Description: oral administration
Study NCT05539924 — intervention group
Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Pregabalin 150mg gabapentin 400mg
Description: oral administration
Study NCT04883918 — intervention group
Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: ASC930
Description: 4 intravenous doses of ASC930
Study NCT06086457 — intervention group
Intervention type: RADIATION
Group type: EXPERIMENTAL
Intervention: Radiation
Description: IMRT/VMAT technique. Patients receive radiotherapy once daily, 5 days a week for an average of 5 weeks. Radiotherapy is delivered to achieve a dosage of 50Gy in 25 fractions to planning gross tumor volume (PGTV) with involved site included.
Study NCT06086457 — intervention group
Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: TP or PF regimen depended on investigator's choice.
Description: A maximum of six cycles was recommended for chemotherapy. Chemotherapy Regimen 1(TP regimen A): Nab-paclitaxel(Albumin-bound paclitaxel) 110-130mg/ m2，d1，d8; Cisplatin 60-75mg/ m2，d1；Q3W； Chemotherapy Regimen 2 (TP regimen B): Paclitaxel 150-175 mg/m2, d1; Cisplatin 60-75mg/ m2，d1；Q3W； PD-1 inhibitor 200mg, d1, Q3W Chemotherapy Regimen 3 (PF regimen): Capecitabine 800mg/m2, bid, d1-14; Cisplatin 25-30mg/m2, d1,d2, Q3W.
Study NCT06086457 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: TP or PF regimen depended on investigator's choice.
Description: A maximum of six cycles was recommended for chemotherapy. Chemotherapy Regimen 1(TP regimen A): Nab-paclitaxel(Albumin-bound paclitaxel) 110-130mg/ m2，d1，d8; Cisplatin 60-75mg/ m2，d1；Q3W； Chemotherapy Regimen 2 (TP regimen B): Paclitaxel 150-175 mg/m2, d1; Cisplatin 60-75mg/ m2，d1；Q3W； PD-1 inhibitor 200mg, d1, Q3W Chemotherapy Regimen 3 (PF regimen): Capecitabine 800mg/m2, bid, d1-14; Cisplatin 25-30mg/m2, d1,d2, Q3W.
Study NCT06086457 — intervention group
Intervention type: BIOLOGICAL
Group type: ACTIVE_COMPARATOR
Intervention: PD-1 inhibitor
Description: Camrelizumab (200mg, d1, Q3W) was continued until disease progression, unacceptable toxicity, death, physician or patient decision to withdraw, non-compliance, or discontinuation for administrative reasons (up to 35 cycles).