TrialPanorama/TrialPanorama-database huggingface dataset:
Study: NCT05838976

Intervention type: DIAGNOSTIC_TEST
Intervention: Shorter Version of the CTQ-SSS
Description: The intervention in this study is the administration of the shorter version of the CTQ-SSS, a validated questionnaire designed to assess the severity of symptoms and functional limitations associated with carpal tunnel syndrome. The CTQ-SSS consists of 8 items related to symptom severity and 2 items related to functional status. The scores for each set of items are combined to generate symptom severity and functional status scores, which will be used to assess the validity and reliability of the CTQ-SSS in patients with carpal tunnel syndrome undergoing nonsurgical management.
Study: NCT05180019

Intervention type: DEVICE
Intervention: SMD ( Self Monitoring Device)
Description: Automated 3D ultrasound based follicullometry with SMD self-performed by the patient.
Study: NCT04599686

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: ADT
Description: On the day of enrollment, luteinizing hormone-releasing hormone agonist (LHRHa) was given for ADT.

Intervention type: RADIATION
Group type: EXPERIMENTAL
Intervention: SBRT
Description: Evaluating men with oligometastatic prostate cancer lesions randomized to stereotactic body radiation therapy (SBRT) (3-5 fractions).
Study: NCT05648448

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Oseltamivir
Description: Oral oseltamivir 75mg BD for 5/7

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Favipiravir
Description: Oral favipiravir 1800mg BD D0 and 800mg BD for a further 4/7

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Zanamivir
Description: Inhaled zanamivir 10mg BD for 5/7

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Baloxavir
Description: Oral baloxavir:~* \<80kg- single dose of 40mg on D0~* ≥80kg- single dose of 80mg on D0
Study: NCT05038501

Intervention type: OTHER
Intervention: To study comorbidities in patients undergoing Oncosurgeries
Description: In the Preoperative Anaesthesia checkup we will study prevalence of comorbidities as Coronary artery Disease, Hypertension, Diabetes Mellitus , Hypothyroidism and prior Corona Virus Infection in patients undergoing Oncosurgeries
Study: NCT04021121

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: LZD
Description: LZD 1200 mg daily

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: LZD
Description: LZD 1200 mg daily

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: High dose RIF
Description: RIF 35 mg/kg/day

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: High dose RIF
Description: RIF 35 mg/kg/day

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Standard dose RIF
Description: RIF 10 mg/kg/day

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Standard dose RIF
Description: RIF 10 mg/kg/day
Study: NCT04878484

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: TCRT-ESO-A2
Description: TCRT-ESO-A2 is an autologous cell therapy comprised of a subject's T cells stimulated ex vivo and transduced with a lentiviral vector encoding an affinity enhanced TCR targeting tumor-associated antigen NY-ESO-1.

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: TCRT-ESO-A2
Description: TCRT-ESO-A2 is an autologous cell therapy comprised of a subject's T cells stimulated ex vivo and transduced with a lentiviral vector encoding an affinity enhanced TCR targeting tumor-associated antigen NY-ESO-1.

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: TCRT-ESO-A2
Description: TCRT-ESO-A2 is an autologous cell therapy comprised of a subject's T cells stimulated ex vivo and transduced with a lentiviral vector encoding an affinity enhanced TCR targeting tumor-associated antigen NY-ESO-1.
Study: NCT05828303

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: TPX-0005
Description: Oral TPX-0005 capsules

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Metformin Hydrochloride
Description: oral solution

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Digoxin
Description: oral tablet

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Rosuvastatin Calcium
Description: oral tablet
Study: NCT04711928

Intervention type: BEHAVIORAL
Intervention: Physical activity and sedentary behaviour
Description: Athletes with a high physical activity and a low or high sedentary time
Study: NCT06347900

Intervention type: DIAGNOSTIC_TEST
Intervention: Pentacam (corneal topographic changes detection), Polysymnography
Description: Pentacam for recording corneal parameters in different stages of OSA patients. Polysymnography for for detction of hyponea, oxygen saturation and desaturation and staging of OSA in different patients.

Intervention type: DIAGNOSTIC_TEST
Intervention: Pentacam (corneal topographic changes detection), Polysymnography
Description: Pentacam for recording corneal parameters in different stages of OSA patients. Polysymnography for for detction of hyponea, oxygen saturation and desaturation and staging of OSA in different patients.

Intervention type: DIAGNOSTIC_TEST
Intervention: Pentacam (corneal topographic changes detection), Polysymnography
Description: Pentacam for recording corneal parameters in different stages of OSA patients. Polysymnography for for detction of hyponea, oxygen saturation and desaturation and staging of OSA in different patients.

Intervention type: DIAGNOSTIC_TEST
Intervention: Pentacam (corneal topographic changes detection), Polysymnography
Description: Pentacam for recording corneal parameters in different stages of OSA patients. Polysymnography for for detction of hyponea, oxygen saturation and desaturation and staging of OSA in different patients.
Study: NCT04881032

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Polysiloxane Gd-Chelates based nanoparticles (AGuIX)
Description: Four intravenous injections of AGuIX will be delivered. Phase I : Three dose levels may be explored 50 mg/kg, 75 mg/kg and 100 mg/ kg. Phase II : recommended dose

Intervention type: RADIATION
Group type: EXPERIMENTAL
Intervention: radiotherapy
Description: 60 Gy in 6 weeks

Intervention type: RADIATION
Group type: SHAM_COMPARATOR
Intervention: radiotherapy
Description: 60 Gy in 6 weeks

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Temozolomide
Description: Concomitant chemotherapy consists of temozolomide (TMZ) at a dose of 75 mg per square meter per day, given 7 days per week from the first day of radiotherapy until the last day of radiotherapy.~After a 4 week break after concomitant treatment, patient were then received up to 6 cycles of adjuvant TMZ according to the standard 5-day schedule every 28 days .

Intervention type: DRUG
Group type: SHAM_COMPARATOR
Intervention: Temozolomide
Description: Concomitant chemotherapy consists of temozolomide (TMZ) at a dose of 75 mg per square meter per day, given 7 days per week from the first day of radiotherapy until the last day of radiotherapy.~After a 4 week break after concomitant treatment, patient were then received up to 6 cycles of adjuvant TMZ according to the standard 5-day schedule every 28 days .
Study: NCT04796623

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: TQB3616 capsules
Description: TQB3616 capsules 180 mg given orally, once daily in 28-day cycle.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Fulvestrant injection
Description: Fulvestrant injection was given at a fixed dose of 500mg on day 1, day 15 of the first cycle and day 1 of each subsequent cycle, and each cycle is 28 days.
Study: NCT04699110

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Adrenaline
Description: Treatment group will receive adrenaline (100 to 400 mcg) for the treatment of No-reflow

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Adenosine
Description: Control group will receive adenosine (100 to 400 mcg)
Study: NCT05268575

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: performing endoscopy
Description: Hemorrhoids will be treated by endoscopic sclerotherapy or endoscopic rubber band ligation or endoscopic sclerotherapy combined with rubber band ligation

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: performing endoscopy
Description: Hemorrhoids will be treated by endoscopic sclerotherapy or endoscopic rubber band ligation or endoscopic sclerotherapy combined with rubber band ligation

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: performing endoscopy
Description: Hemorrhoids will be treated by endoscopic sclerotherapy or endoscopic rubber band ligation or endoscopic sclerotherapy combined with rubber band ligation
Study: NCT05941325

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: fruquintinib
Description: VEGF receptor tyrosine-kinase inhibitor：fruquintinib（4mg), Oral，qd, d1-d14, Q3w，Until disease progression or intolerable toxicity occurs.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Envafolimab
Description: anti-PD-1 immune checkpoint inhibitor：Envafolimab（400mg), subcutaneous injection, d1, Q3w，Until disease progression or intolerable toxicity occurs.
Study: NCT05648448

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Molnupiravir
Description: Oral molnupiravir 800mg BD for 5/7

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Peramivir
Description: Intravenous peramivir 600mg once only

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Laninamivir
Description: Inhaled laninamivir 40mg once only
Study: NCT06358443

Intervention type: DIETARY_SUPPLEMENT
Group type: EXPERIMENTAL
Intervention: Jarlsberg cheese
Description: Jarlsberg cheese + Vitamin D ampulles + Calcium
Study: NCT05027399

Intervention type: BEHAVIORAL
Group type: ACTIVE_COMPARATOR
Intervention: Nursing teleconsultation for lifestyle changes
Description: Guidance on better medication adherence, monitoring of signs and symptoms of exacerbation of heart failure, guidance on the need for fluid restriction.
Study: NCT05762835

Intervention type: BEHAVIORAL
Group type: EXPERIMENTAL
Intervention: Virtual family-centered rounds (FCR)
Description: Parents will be given the option to join FCR virtually or in-person; this intervention is changing the behavior of how providers deliver healthcare and how parents engage in their child's care.~The NICU team members will use a computer with a speaker and pan-tilt-zoom camera, mounted on a stand with wheels to launch telehealth connections using the secure application called ExtendedCare. From within this telehealth connection, a NICU team member will send an electronic message (e.g. via text or email) to the subscribed parent(s) and wait for the parent to join the visit to establish a secure videoconference. The message to the parent includes a link that can be clicked to open a browser that allows the parent to join the telehealth visit. FCR will then proceed in usual fashion with the NICU team members and - if in attendance - parent(s).
Study: NCT04313959

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Ropivacaine 0.2% Injectable Solution
Description: Single-shot ultrasound-guided erector spine plane block of 0.2% ropivacaine

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Ropivacaine 0.2% Injectable Solution
Description: Single-shot ultrasound-guided erector spine plane block of 0.2% ropivacaine

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Ropivacaine 0.2% + Dexamethasone
Description: Addiction of 5 mg/ml dexamethasone in 0.2% ropivacaine solution
Study: NCT04695340

Intervention type: DIETARY_SUPPLEMENT
Group type: EXPERIMENTAL
Intervention: Psyllium
Description: Psyllium is given to patients
Study: NCT05263999

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: Itolizumab
Description: Itolizumab \[Bmab600\]
Study: NCT06277635

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Silymarin
Description: Silymarin is randomly assigned to the participants for 12 weeks during study.

Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Placebo
Description: Placebo is randomly assigned to the participants for 12 weeks during study.
Study: NCT05536024

Intervention type: DIAGNOSTIC_TEST
Intervention: Prediction of glioma grading and molecular subtype
Description: Prediction of WHO grading(II/III/IV), IDH gene mutation status, ATRX deletion status, 1p/19q deletion status, CDKN2A/B homozygous deletion status, TERT gene mutation status, epidermal growth factor receptor (EGFR) mutation status, chromosome 7gain and chromosome 10 less status, H3F3A G34 (H3.3 G34) mutation status, H3 K27M mutation status
Study: NCT05365672

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: MIC
Description: Single intravenous infusion of 1.5x10exp8 MIC per kg of body weight

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: MIC
Description: Single intravenous infusion of 1.5x10exp8 MIC per kg of body weight

Intervention type: OTHER
Group type: OTHER
Intervention: Standard of Care
Description: No application of the investigational medicinal product MIC
Study: NCT05648448

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Oseltamivir and Baloxavir
Description: Oseltamivir 75mg BD for 5/7 and~Baloxavir:~* \<80kg- single dose of 40mg on D0~* ≥80kg- single dose of 80mg on D0

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Oseltamivir and Favipiravir
Description: Oseltamivir 75mg BD for 5/7 and~favipiravir 1800mg BD D0 and 800mg BD for a further 4/7

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Favipiravir and Baloxavir
Description: favipiravir 1800mg BD D0 and 800mg BD for a further 4/7~Baloxavir:~* \<80kg- single dose of 40mg on D0~* ≥80kg- single dose of 80mg on D0
Study: NCT06141902

Intervention type: OTHER
Group type: OTHER
Intervention: Jing Si Herbal Drink
Description: Jing Si Herbal Drink
Study: NCT05263999

Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: EQ001 Placebo
Description: EQ001 Placebo
Study: NCT04903457

Intervention type: DEVICE
Group type: EXPERIMENTAL
Intervention: Transcranial Direct Current Stimulation
Description: Transcranial direct current stimulation is a form of noninvasive neuromodulation that uses constant and low direct current delivered via electrodes on the scalp.

Intervention type: BEHAVIORAL
Group type: EXPERIMENTAL
Intervention: Motor learning
Description: Sequential finger tapping task training is applied to stroke patients.

Intervention type: BEHAVIORAL
Group type: ACTIVE_COMPARATOR
Intervention: Motor learning
Description: Sequential finger tapping task training is applied to stroke patients.
Study: NCT06158425

Intervention type: RADIATION
Intervention: long-leg radiograph
Description: A flat-panel digital radiography(DR) equipment (Siemens DR AXIOM Aristos AX/VX) was used to capture full-length bipedal lower extremities in a standing position. The technician moved the detector from top to bottom, capturing four parts: the bilateral hip joints, femur, tibia and fibula and ankle joint. The exposure parameters for each part were as follows: 1st exposure - 85kV, 75mAs; 2nd exposure - 80kV, 50mAs; 3rd exposure - 75kV, 40mAs; 4th exposure - 68kV, 20mAs. The distance from the source (kv-kg) was 300cm, and the field of view was 43.18cm x 43.18cm. All 4 X-rays were stitched using the Siemens DR Station.

Intervention type: RADIATION
Intervention: long-leg radiograph
Description: A flat-panel digital radiography(DR) equipment (Siemens DR AXIOM Aristos AX/VX) was used to capture full-length bipedal lower extremities in a standing position. The technician moved the detector from top to bottom, capturing four parts: the bilateral hip joints, femur, tibia and fibula and ankle joint. The exposure parameters for each part were as follows: 1st exposure - 85kV, 75mAs; 2nd exposure - 80kV, 50mAs; 3rd exposure - 75kV, 40mAs; 4th exposure - 68kV, 20mAs. The distance from the source (kv-kg) was 300cm, and the field of view was 43.18cm x 43.18cm. All 4 X-rays were stitched using the Siemens DR Station.
Study: NCT06347029

Intervention type: PROCEDURE
Group type: EXPERIMENTAL
Intervention: Urine sampling
Description: Urine sampling

Intervention type: PROCEDURE
Group type: EXPERIMENTAL
Intervention: Urine sampling
Description: Urine sampling
Study: NCT05226260

Intervention type: BEHAVIORAL
Group type: EXPERIMENTAL
Intervention: Default Duration order Panel
Description: The SSTI order panel will present itself when a provider types in either a drug name or diagnosis (cellulitis, impetigo, etc). Clinicians in control clinics will have access to a basic order panel which will include diagnosis and corresponding antibiotic of choice. Clinicians in intervention clinics will have access to order panels with the following additional components: prepopulated order duration fields that default to the recommended treatment duration.
Study: NCT06342427

Intervention type: DIAGNOSTIC_TEST
Intervention: DESTINEX
Description: A panel of microRNA, whose expression level is tested in serum samples.

Intervention type: DIAGNOSTIC_TEST
Intervention: DESTINEX
Description: A panel of microRNA, whose expression level is tested in serum samples.

Intervention type: DIAGNOSTIC_TEST
Intervention: DESTINEX
Description: A panel of microRNA, whose expression level is tested in serum samples.

Intervention type: DIAGNOSTIC_TEST
Intervention: DESTINEX
Description: A panel of microRNA, whose expression level is tested in serum samples.
Study: NCT05508906

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: OP-1250
Description: OP-1250 is a small molecule and a CERAN being developed for the treatment of patients with advanced or metastatic ER+ and HER2- breast cancer.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: OP-1250
Description: OP-1250 is a small molecule and a CERAN being developed for the treatment of patients with advanced or metastatic ER+ and HER2- breast cancer.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: OP-1250
Description: OP-1250 is a small molecule and a CERAN being developed for the treatment of patients with advanced or metastatic ER+ and HER2- breast cancer.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Ribociclib
Description: All subjects in Treatment Group 1 will receive OP-1250 in combination with ribociclib.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Alpelisib
Description: All subjects in Treatment Group 2 will receive OP-1250 in combination with alpelisib.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Everolimus
Description: All subjects in Treatment Group 3 will receive OP-1250 in combination with everolimus.
Study: NCT06392672

Intervention type: BEHAVIORAL
Group type: EXPERIMENTAL
Intervention: Intervention Group: Group to which the clinical pharmacist makes recommendations
Description: The drugs administered to patients during scheduled hospital visits will be recorded. A detailed medication review will be conducted by the clinical pharmacist. As a result of a comprehensive evaluation, recommendations were made to doctors regarding drug-related problems and were recorded.
Study: NCT06024772

Intervention type: PROCEDURE
Group type: EXPERIMENTAL
Intervention: ultiparametric Magnetic Resonance Imaging
Description: Undergo mp-MRI

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Perflutren lipid microsphere
Description: Given IV

Intervention type: PROCEDURE
Group type: EXPERIMENTAL
Intervention: Transrectal Ultrasound
Description: Undergo transrectal mp-US

Intervention type: PROCEDURE
Group type: EXPERIMENTAL
Intervention: Biopsy of Prostate
Description: Undergo prostate biopsies
Study: NCT04978259

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Remdesivir
Description: Intravenous remdesivir during hospital stay up to 10 days in addition to standard care.
Study: NCT04704453

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Capsaïcin patch (Qutenza®)
Description: Treatment by application of capsaicin 8% (Qutenza®) patches 3 months apart (Month 1, Month 4 and Month 7).

Intervention type: DRUG
Group type: OTHER
Intervention: Amitriptyline (Laroxyl®)
Description: Treatment by amitriptyline (oral solution 40mg/ml), for 9 months at the recommended dose of 25 mg to 75 mg daily.
Study: NCT05458167

Intervention type: DEVICE
Group type: EXPERIMENTAL
Intervention: Hedia Diabetes Assistant bolus calculator with a physical activity module
Description: Hedia Diabetes Assistant bolus calculator with a physical activity module is a software device that calculates an insulin bolus based on blood glucose, carbohydrates and physical activity.

Intervention type: DEVICE
Group type: ACTIVE_COMPARATOR
Intervention: Hedia Diabetes Assistant bolus calculator with a physical activity module
Description: Hedia Diabetes Assistant bolus calculator with a physical activity module is a software device that calculates an insulin bolus based on blood glucose, carbohydrates and physical activity.
Study: NCT05835882

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: Red Blood Cell concentrates from organ donor
Description: Intervention is a 3-step procedure consisting of 1) recovering blood from the donor during organ procurement; 2) processing donor blood to RBC units; 3) transfusing donor blood to recipients, if necessary during surgery.~1. Donor blood recovery. A: Donor evaluation. During the donor workup, the donor coordinator team gathers additional information from the donor relatives. If no contraindication to blood collection exists, the donor-recipient ABO-crossmatch is performed, and if negative the donor is considered eligible. B: Donor blood collection. It is carried out by a trained investigator, through the continuous autotransfusion system CATSmart (Fresenius Kabi) in the surgery room.~2. Donor blood processing, carried out using the continuous flow CATSmart device. About 4 RBC units are collected.~3. Donor RBC unit transfusion to recipients according to procedures usually adopted at our hospital (final hb level 8-9 g/dL).
Study: NCT04303312

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: Benzydamine Hydrochloride
Description: Patients will rinse by mouth three times daily for 20 days

Intervention type: COMBINATION_PRODUCT
Group type: ACTIVE_COMPARATOR
Intervention: Solcoseryl and pumpkin seed oil
Description: Patients will receive by mouth three times daily for 20 days
Study: NCT06251739

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Ivermectin 6 Mg Oral Tablet
Description: A cumulative dose of 60 mg Oral Ivermectin monotherapy (12 mg/day) on five consecutive days (day 1 - day 5) for three consecutive months (180 mg in total)

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Miltefosine Oral Capsule
Description: Oral Miltefosine monotherapy for 12 weeks. 50 mg in the morning and 50 mg in the evening with meal x 84 days (Total 100 mg/day)
Study: NCT04342624

Intervention type: DIETARY_SUPPLEMENT
Group type: EXPERIMENTAL
Intervention: Cinnamon
Description: Cinnamon supplement

Intervention type: OTHER
Group type: PLACEBO_COMPARATOR
Intervention: Placebo
Description: Placebo
Study: NCT06162338

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: LY-M001 Injection
Description: With 5.0 × 10\^12 vg/kg as the initial effective dose (first dose group), 1 to 2 subjects are expected to be included. The first dose group was enrolled by sentinel method, and the first subject in this group was observed for at least 28 days after receiving LY-M001 (dose-limited toxicity \[DLT\] observation period) to enroll the next subject. After the first participant completes the safety evaluation of dosing for at least 28 days, the investigator (PI) and the partner discuss the safety and efficacy data and decide to maintain the first dose or increase/reduce it to another dose group