TrialPanorama/TrialPanorama-database huggingface dataset:
Study: NCT06784843

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Dexmedetomidine as an adjuvant to local anesthesia for peribulbar block
Description: Dexmedetomidine as an adjuvant to a local anesthetic mixture (bupivacaine, lidocaine, and hyaluronidase) for peribulbar block during cataract surgery

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Midazolam as an adjuvant to local anesthesia for peribulbar block
Description: Midazolam as an adjuvant to a local anesthetic mixture (bupivacaine, lidocaine, and hyaluronidase) for peribulbar block during cataract surgery
Study: NCT06785740

Intervention type: DRUG
Intervention: Statin
Description: Statin use
Study: NCT06787508

Intervention type: DEVICE
Group type: EXPERIMENTAL
Intervention: TMS
Description: Continuous high-frequency transcranial magnetic stimulation therapy Targeting the left M1 area, continuous high-frequency stimulation was performed at a frequency of 10Hz with 80-100% TEP for 5 minutes each time, twice a day for a total of 5 days

Intervention type: DEVICE
Group type: SHAM_COMPARATOR
Intervention: TMS
Description: Consistent with the experimental group protocol, the magnetic stimulation probe is a false stimulation probe that only produces sound but does not actually produce stimulation
Study: NCT06784882

Intervention type: DEVICE
Group type: EXPERIMENTAL
Intervention: continuous peripheral nerve block with OnQ pump
Description: For continuous nerve blocks, the infusion pump that will be used are OnQ pumps (Avanos, Alpharetta, GA) and pre-filled with ropivacaine 0.2% and provided by UCSD's Investigational Drug Services.

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: single injection nerve block
Description: An adductor canal single injection nerve block will be performed per standard of care. The adductor canal will be identified by ultrasound in the short-axis view. The distal aspect of the femoral triangle (and beginning of the adductor canal) will be identified distal to the mid-thigh in the ipsilateral limb. Using ultrasound guidance, a standard Tuohy block needle will be advanced through a skin wheal of lidocaine until its tip is in the hypoechoic area immediately distal saphenous nerve adjacent to the femoral artery. Twenty milliliters of ropivacaine 0.5% will be injected in divided doses with repeated negative aspiration.
Study: NCT06786403

Intervention type: DIETARY_SUPPLEMENT
Group type: ACTIVE_COMPARATOR
Intervention: Bromelain
Description: Dietary Supplement: Bromelain 1000 mg/day

Intervention type: DIETARY_SUPPLEMENT
Group type: PLACEBO_COMPARATOR
Intervention: Placebo
Description: Placebo (1000 mg/day)
Study: NCT06424899

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Adebrelimab
Description: This product is administered by intravenously guttae. The recommended dose of subcutaneous injection is 20mg/kg, administered every 3 Weeks (Q3W).

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Adebrelimab
Description: This product is administered by intravenously guttae. The recommended dose of subcutaneous injection is 20mg/kg, administered every 3 Weeks (Q3W).

Intervention type: RADIATION
Group type: EXPERIMENTAL
Intervention: radical chemoradiotherapy
Description: The total dose of radiotherapy was 60 Gy ± 10% (54 Gy - 66 Gy). The minimum technical standard for radiotherapy is the three dimensional conformal radiotherapy (3D-CRT) planned by CT.

Intervention type: RADIATION
Group type: ACTIVE_COMPARATOR
Intervention: radical chemoradiotherapy
Description: The total dose of radiotherapy was 60 Gy ± 10% (54 Gy - 66 Gy). The minimum technical standard for radiotherapy is the three dimensional conformal radiotherapy (3D-CRT) planned by CT.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Platinum based chemotherapy
Description: Platinum based chemotherapy: Platinum drug must be one of cisplatin, carboplatin or nedaplatin; The other drug must contain one of the following: etoposide, vinorelbine, vinblastine, pemetrexed, taxanes (e.g., paclitaxel, docetaxel, albumin paclitaxel, paclitaxel liposomes) or gemcitabine (gemcitabine is not permitted in concurrent chemoradiotherapy regimens).

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Platinum based chemotherapy
Description: Platinum based chemotherapy: Platinum drug must be one of cisplatin, carboplatin or nedaplatin; The other drug must contain one of the following: etoposide, vinorelbine, vinblastine, pemetrexed, taxanes (e.g., paclitaxel, docetaxel, albumin paclitaxel, paclitaxel liposomes) or gemcitabine (gemcitabine is not permitted in concurrent chemoradiotherapy regimens).
Study: NCT05056181

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: Physical Activity
Description: Physical activity
Study: NCT05520424

Intervention type: DIETARY_SUPPLEMENT
Group type: EXPERIMENTAL
Intervention: The Daily Supplement
Description: The ingredient list of the product includes the following:~400mg of curcumin (Longvida) 300mg of lemon balm extract (Cyracos) 200mg of American ginseng (Cereboost) 50mg of epigallocatechin gallate derived from green tea Organic oat milk powder Phosphatidylserine (SerinAid) (active) B6 (in the form of P5P) Folate (Quatrefolic) B12 Silica (non-active)
Study: NCT04618991

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: Filling the Quebec Sleep Questionnaire
Description: Filling the Quebec Sleep Questionnaire (QSQ) by the pre-surgery patient, then at 3 months post surgery and 1 year post surgery.
Study: NCT06103071

Intervention type: PROCEDURE
Group type: ACTIVE_COMPARATOR
Intervention: Sweeping of membranes
Description: After informed consent all the patients in interventional group will have sweeping of membranes from 37 weeks of pregnancy . It will be repeated weekly till 40 weeks.
Study: NCT06065189

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: CS-101 injection
Description: Autologous CD34+ hematopoietic stem cell suspension modified by in vitro base editing technique
Study: NCT05087251

Intervention type: BEHAVIORAL
Group type: EXPERIMENTAL
Intervention: Five Psycho-educational Session(s)
Description: 5 psychoeducational sessions focused on skills for enhancing wellbeing, relationships, social support, and ability to cope with uncertainty

Intervention type: BEHAVIORAL
Group type: EXPERIMENTAL
Intervention: One Psycho-educational Session(s)
Description: 1 session focused on exploring goals and expectations for post-treatment quality of life, including supportive listening; assessment of unmet needs; preferences for support, and tailored referral recommendations
Study: NCT05051891

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Orelabrutinib and R-CHOP
Description: Orelabrutinib in Combinaion with Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (R-CHOP)

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: R-CHOP
Description: Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (R-CHOP)
Study: NCT05621395

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: E-OJ-01
Description: 1 capsule (400 mg) orally to be taken after breakfast daily for 60 days

Intervention type: OTHER
Group type: PLACEBO_COMPARATOR
Intervention: Microcrystalline cellulose
Description: 1 capsule (400 mg) orally to be taken after breakfast daily for 60 days
Study: NCT00975468

Intervention type: OTHER
Group type: ACTIVE_COMPARATOR
Intervention: Pressure Controlled vs. Volume Controlled Ventilation during OLV
Description: Ventilation will be initiated with a tidal volume of 8 ml.kg-1 in Volume-controlled group and with a peak airway pressure that provided a tidal volume of 8 ml.kg-1 in pressure-controlled group. R.R will be adjusted to achieve an arterial PaCO2 4.5-6 kPa and FiO2 will be increased to 1.0 during OLV.

Intervention type: OTHER
Group type: PLACEBO_COMPARATOR
Intervention: Pressure Controlled vs. Volume Controlled Ventilation during OLV
Description: Ventilation will be initiated with a tidal volume of 8 ml.kg-1 in Volume-controlled group and with a peak airway pressure that provided a tidal volume of 8 ml.kg-1 in pressure-controlled group. R.R will be adjusted to achieve an arterial PaCO2 4.5-6 kPa and FiO2 will be increased to 1.0 during OLV.
Study: NCT06373198

Intervention type: OTHER
Intervention: standard of care
Description: An evaluation of the positivity of the hepatitis C test will be carried out. Positive patients will be included in the follow-up and specific treatment will be requested to achieve a cure. Standard of care will be applied.
Study: NCT05176938

Intervention type: PROCEDURE
Group type: EXPERIMENTAL
Intervention: Ultrasound guided Thoracic Interfascial plane Block (TIFB)
Description: Patients of the group will be placed supine and elevate arm to the head, Serratus intercostal plane block will be with the probe in the midaxillary line, The subcutaneous tissue and serratus muscle will be identified in the superficial plane, whereas the external intercostal muscles will be identified in the intermediate plane and finally in the deep plane the ribs, pleura and lung will be identified. The needle will be advanced from caudal to cranial direction after giving 3 ml lidocaine locally. In-plane technique was used until the tip of the needle placed between the serratus anterior muscle and the external intercostals muscle a volume of 20 ml plain bupivacaine will be injected.

Intervention type: PROCEDURE
Group type: EXPERIMENTAL
Intervention: Ultrasound guided Erector Spinae plane Block (ESPB)
Description: The patient will be placed in setting position and a superficial (5-12 MHz) ultrasound transducer will be placed in a longitudinal orientation, 3 cm lateral to the T4 spinous process. An 8-cm 22-gauge spinal needle will be inserted in cephalic direction after giving 3 ml lidocaine locally until the needle tip hit the transverse process of T4 under ultrasound image visualization, then the needle will be withdrawn slowly to be within the interfacial plane below the erector spinae muscle, then the anesthetic mixture will be injected here. Successful injection will be evidenced by visible linear free spread (cranially and caudally) of injectate below the muscle.
Study: NCT04835454

Intervention type: DIAGNOSTIC_TEST
Intervention: piRNAs, miRNA-194, regucalcin and plasma aminoacids levels
Description: PIWI-interacting RNAs (piRNAs), a class of small nuclear RNA molecules, are associated with the PIWI proteins. MicroRNAs (miRNAs) are conserved small non-coding RNAs (19-22 nucleotide-long) that mediate post-transcriptional regulation of gene expression, affecting mRNA stability and translation by binding complementary sites on target mRNAs. Regucalcin (RGN) is an inhibitory protein of calcium signaling with calcium-binding properties. It plays a multifunctional role in the regulation of cell functions, including maintenance of intracellular calcium homeostasis, inhibitions of protein kinases and protein phosphatases linked to cell signaling process, suppressions of protein production and nuclear DNA and RNA synthesis.Free amino acids, in biological fluids can be a reduced invasive method associated to a high diagnostic potential. It was found that free amino acid profiles vary depending on type of cancer and its stage.

Intervention type: DIAGNOSTIC_TEST
Intervention: piRNAs, miRNA-194, regucalcin and plasma aminoacids levels
Description: PIWI-interacting RNAs (piRNAs), a class of small nuclear RNA molecules, are associated with the PIWI proteins. MicroRNAs (miRNAs) are conserved small non-coding RNAs (19-22 nucleotide-long) that mediate post-transcriptional regulation of gene expression, affecting mRNA stability and translation by binding complementary sites on target mRNAs. Regucalcin (RGN) is an inhibitory protein of calcium signaling with calcium-binding properties. It plays a multifunctional role in the regulation of cell functions, including maintenance of intracellular calcium homeostasis, inhibitions of protein kinases and protein phosphatases linked to cell signaling process, suppressions of protein production and nuclear DNA and RNA synthesis.Free amino acids, in biological fluids can be a reduced invasive method associated to a high diagnostic potential. It was found that free amino acid profiles vary depending on type of cancer and its stage.

Intervention type: DIAGNOSTIC_TEST
Intervention: piRNAs, miRNA-194, regucalcin and plasma aminoacids levels
Description: PIWI-interacting RNAs (piRNAs), a class of small nuclear RNA molecules, are associated with the PIWI proteins. MicroRNAs (miRNAs) are conserved small non-coding RNAs (19-22 nucleotide-long) that mediate post-transcriptional regulation of gene expression, affecting mRNA stability and translation by binding complementary sites on target mRNAs. Regucalcin (RGN) is an inhibitory protein of calcium signaling with calcium-binding properties. It plays a multifunctional role in the regulation of cell functions, including maintenance of intracellular calcium homeostasis, inhibitions of protein kinases and protein phosphatases linked to cell signaling process, suppressions of protein production and nuclear DNA and RNA synthesis.Free amino acids, in biological fluids can be a reduced invasive method associated to a high diagnostic potential. It was found that free amino acid profiles vary depending on type of cancer and its stage.
Study: NCT03826524

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Epinephrine
Description: Epinephrine 1mg 1:10000 (10cc) per dose

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Epinephrine
Description: Epinephrine 1mg 1:10000 (10cc) per dose
Study: NCT05857254

Intervention type: OTHER
Intervention: Patient with chronic intestinal failure
Description: The negociation component will be assessed during an office visit with the help of forms, by the difference between  ideal  parenteral nutrition prescription proposed by prescriber and the  final  prescription, that the patient ultimately receives at the end of the office visit.~The compliance component will be assessed by a telephone interview, 8 weeks after the office visit.
Study: NCT05214664

Intervention type: PROCEDURE
Group type: ACTIVE_COMPARATOR
Intervention: Anesthesia
Description: Once the anesthesia is performed by the Anesthesia practitioner either with the EZ-Block® device or by the conventional freehand technique, the surgical procedure will be performed in the same way in both arms, and for each tooth, by the Surgery practitioner:~* The Surgery practitioner takes charge of the patient after a post-anesthesia time of 10 minutes and performs a new antisepsis then completes the anesthesia by anesthetizing the buccal and lingual nerve with a carpule of 1.8ml of articaine + adrenaline at 1/200000.~* The Surgery practitioner starts the surgical procedure.~* In the absence of pain, the practitioner Surgery carries out the surgical act in its totality (situation of success for the principal criterion of the study) then records the EVA at the end of the intervention.

Intervention type: PROCEDURE
Group type: EXPERIMENTAL
Intervention: Anesthesia
Description: Once the anesthesia is performed by the Anesthesia practitioner either with the EZ-Block® device or by the conventional freehand technique, the surgical procedure will be performed in the same way in both arms, and for each tooth, by the Surgery practitioner:~* The Surgery practitioner takes charge of the patient after a post-anesthesia time of 10 minutes and performs a new antisepsis then completes the anesthesia by anesthetizing the buccal and lingual nerve with a carpule of 1.8ml of articaine + adrenaline at 1/200000.~* The Surgery practitioner starts the surgical procedure.~* In the absence of pain, the practitioner Surgery carries out the surgical act in its totality (situation of success for the principal criterion of the study) then records the EVA at the end of the intervention.
Study: NCT05152303

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Remimazolam Tosilate
Description: Loading dose: 0.08mg/kg IV of Remimazolam Tosilate, Maintenance dose: IV remimazolam tosilate, dose range 0-2.0mg/kg/h, increment or decrement of 0.1mg/kg/h

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Remimazolam Tosilate
Description: Loading dose: 0.08mg/kg, Drug: Propofol Injection Maintenance dose: IV remimazolam tosilate, dose range 0-2.0mg/kg/h, increment or decrement of 0.2mg/kg/h IV of Propofol Injection
Study: NCT05429047

Intervention type: BIOLOGICAL
Intervention: Tozinameran
Description: Tozinameran during pregnancy

Intervention type: OTHER
Intervention: COVID-19
Description: SARS-CoV-2 infection during pregnancy

Intervention type: OTHER
Intervention: No SARS-CoV-2 exposure
Description: No SARS-CoV-2 exposure during pregnancy

Intervention type: OTHER
Intervention: No SARS-CoV-2 exposure
Description: No SARS-CoV-2 exposure during pregnancy
Study: NCT05942391

Intervention type: BEHAVIORAL
Group type: EXPERIMENTAL
Intervention: Cognitive behavioral therapy (CBT)
Description: The intervention is brief-intensive, guided exposure therapy and consists of 16 sessions exposure therapy, spread over 4 half-days in 2 weeks plus 4 follow-up sessions within 3 months.

Intervention type: BEHAVIORAL
Group type: ACTIVE_COMPARATOR
Intervention: Cognitive behavioral therapy (CBT)
Description: The intervention is brief-intensive, guided exposure therapy and consists of 16 sessions exposure therapy, spread over 4 half-days in 2 weeks plus 4 follow-up sessions within 3 months.
Study: NCT03928275

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: Interleukin-2
Description: IL-2 is prepared as 4 million International Units (IU) per 0.8ml at a total dose of 500,000 IU in 0.1ml of sterilized saline (0.9%, m/v)/lesion.

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: Combination therapy Interleukin-2 and Bacillus Calmette Guerin
Description: BCG (OncoTICE solutions 1-8 x 10-8 Colony Forming Units (CFU)) will be administered at a maximum dose of 3.2 million CFU per treatment at a maximum of 1.6 million CFU per lesion (max 2 lesions).~IL-2 is prepared as 4 million International Units (IU) per 0.8ml at a total dose of 500,000 IU in 0.1ml of sterilized saline (0.9%, m/v)/lesion (in remaining lesions).
Study: NCT04934163

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: Flow rate setting of high-flow nasal cannula (initially 60L/min)
Description: The flow rates of HFNC(high-flow nasal cannula) is set as 60L/min(temperature:34°C).~Initial FiO2 is 100%, which would be titrated down to the minimal level to keep SpO2 ≥ 92% within 30 minutes after extubation.~After that, the flow rate setting is fixed for 24hrs +/- 6 hrs; then, is tapered to 30 L/min and kept for 12 more hours. Afterwards, HFNC would be changed to conventional oxygen therapy to keep SpO2≥ 92%.

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: Flow rate setting of high-flow nasal cannula (initially 40L/min)
Description: The flow rates of HFNC(high-flow nasal cannula) is set as 40L/min(temperature:34°C).~Initial FiO2 is 100%, which would be titrated down to the minimal level to keep SpO2 ≥ 92% within 30 minutes after extubation.~After that, the flow rate setting is fixed for 24hrs +/- 6 hrs; then, is tapered to 30 L/min and kept for 12 more hours. Afterwards, HFNC would be changed to conventional oxygen therapy to keep SpO2≥ 92%.
Study: NCT04404049

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: UB-421(25 mg/kg) Q2W
Description: Monoclonal antibody by IV infusion plus standard ART

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: UB-421(25 mg/kg) Q4W
Description: Monoclonal antibody by IV infusion plus standard ART
Study: NCT04788745

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Trimetazidine Dihydrochloride
Description: Oral tablet, twice-daily
Study: NCT04948827

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: SBP-9330
Description: SBP-9330 oral capsules

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: SBP-9330
Description: SBP-9330 oral capsules

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: SBP-9330
Description: SBP-9330 oral capsules

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: SBP-9330
Description: SBP-9330 oral capsules

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: SBP-9330
Description: SBP-9330 oral capsules

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: SBP-9330
Description: SBP-9330 oral capsules

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: SBP-9330
Description: SBP-9330 oral capsules

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: SBP-9330
Description: SBP-9330 oral capsules

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: SBP-9330
Description: SBP-9330 oral capsules

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: SBP-9330
Description: SBP-9330 oral capsules

Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Placebo
Description: Placebo oral capsules

Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Placebo
Description: Placebo oral capsules

Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Placebo
Description: Placebo oral capsules
Study: NCT06027255

Intervention type: DIAGNOSTIC_TEST
Group type: OTHER
Intervention: IL-6
Description: Compare IL-6 level , as a marker of inflammation in all the 3 groups:~* POTS patients~* post-COVID-19 POTS~* gender, age, and BMI-matched controls, with history of COVID-19 infection without sequelae.

Intervention type: DIAGNOSTIC_TEST
Group type: OTHER
Intervention: IL-6
Description: Compare IL-6 level , as a marker of inflammation in all the 3 groups:~* POTS patients~* post-COVID-19 POTS~* gender, age, and BMI-matched controls, with history of COVID-19 infection without sequelae.

Intervention type: DIAGNOSTIC_TEST
Group type: OTHER
Intervention: IL-6
Description: Compare IL-6 level , as a marker of inflammation in all the 3 groups:~* POTS patients~* post-COVID-19 POTS~* gender, age, and BMI-matched controls, with history of COVID-19 infection without sequelae.

Intervention type: DIAGNOSTIC_TEST
Group type: OTHER
Intervention: cytokines (IL-17, and IFN-ɣ)
Description: Compare Proinflammatory cells and its secreted cytokines (IL-17, and IFN-ɣ) in all the 3 groups:~* POTS patients~* post-COVID-19 POTS~* gender, age, and BMI-matched controls, with history of COVID-19 infection without sequelae

Intervention type: DIAGNOSTIC_TEST
Group type: OTHER
Intervention: cytokines (IL-17, and IFN-ɣ)
Description: Compare Proinflammatory cells and its secreted cytokines (IL-17, and IFN-ɣ) in all the 3 groups:~* POTS patients~* post-COVID-19 POTS~* gender, age, and BMI-matched controls, with history of COVID-19 infection without sequelae

Intervention type: DIAGNOSTIC_TEST
Group type: OTHER
Intervention: cytokines (IL-17, and IFN-ɣ)
Description: Compare Proinflammatory cells and its secreted cytokines (IL-17, and IFN-ɣ) in all the 3 groups:~* POTS patients~* post-COVID-19 POTS~* gender, age, and BMI-matched controls, with history of COVID-19 infection without sequelae

Intervention type: BEHAVIORAL
Group type: OTHER
Intervention: Compass 31
Description: Autonomic symptoms assessment questionnaire (COMPASS 31), in post-COVID-19 POTS and compare with POTS patients

Intervention type: BEHAVIORAL
Group type: OTHER
Intervention: Compass 31
Description: Autonomic symptoms assessment questionnaire (COMPASS 31), in post-COVID-19 POTS and compare with POTS patients

Intervention type: BEHAVIORAL
Group type: OTHER
Intervention: Compass 31
Description: Autonomic symptoms assessment questionnaire (COMPASS 31), in post-COVID-19 POTS and compare with POTS patients
Study: NCT04829630

Intervention type: BIOLOGICAL
Group type: OTHER
Intervention: rabies vaccine
Description: * day 0 : questionnaire, blood sampling and vaccine booster (a single session of two intradermal doses of 0.1 mL)~* day 7 : questionnaire and blood sampling