TrialPanorama/TrialPanorama-database huggingface dataset:
Study: NCT04463576

Intervention type: OTHER
Intervention: Discharge Prescription
Description: All hospital discharge prescriptions for patients aged 65 or over hospitalized or seen in consultation in the cardiology, internal medicine and neurology divisions of the Bordeaux and Rennes University Hospital and Georges Pompidou European Hospital will be recorded between June 1, 2018 and June 1, 2019.
Study: NCT05733598

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: RP2
Description: Genetically modified herpes simplex type 1 virus for tumor lysis and immune stimulation.

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: Bevacizumab
Description: Anti-VEGF therapy.

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: Atezolizumab
Description: Anti-PD-L1 monoclonal antibody.
Study: NCT05802056

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: Aldesleukin
Description: Given IP

Intervention type: PROCEDURE
Group type: EXPERIMENTAL
Intervention: Biopsy
Description: Undergo biopsy

Intervention type: PROCEDURE
Group type: EXPERIMENTAL
Intervention: Biospecimen Collection
Description: Undergo collection of blood and tissue samples

Intervention type: PROCEDURE
Group type: EXPERIMENTAL
Intervention: Computed Tomography
Description: Undergo PET/CT

Intervention type: PROCEDURE
Group type: EXPERIMENTAL
Intervention: Diagnostic Laparoscopy
Description: Undergo diagnostic laparoscopy

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Fluorouracil
Description: Given IV

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Leucovorin Calcium
Description: Given IV
Study: NCT05343442

Intervention type: PROCEDURE
Group type: EXPERIMENTAL
Intervention: Percutaneous tracheostomy
Description: Guidewire dilating forceps (Grigges') technique was the method which has been applied during our work. Proper positioning: patient's neck was extended as much as possible by placing a rolled towel between the shoulder blades, the patient's neck and the bed were maintained in neutral position. The operative site was sterilized before draping with 10% povidone iodine solution. Lidocaine 2% was used as local anesthetic prior to beginning the intervention.~Transverse (1 cm) skin incision was made midway between the cricoid cartilage and the suprasternal notch, i.e., opposite the 2nd - 3rd or 3rd - 4th tracheal rings. Blunt dissection of subcutaneous fat and pre-tracheal tissue with mosquito clamp in a vertical direction was done till the tracheal rings were palpable.
Study: NCT05367492

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Double Blind Varenicline
Description: For participants 16-17 years old, ≤ 55 kg:~* 0.5 mg once daily for 7 days, then~* 0.5 mg twice daily for 11 weeks~For participants 16-17 years old, \>55 kg:~* 0.5 mg once daily or 3 days,~* 0.5 mg twice daily for 4 days~* 1.0 mg twice daily for 11 weeks~For participants 18+ years old:~* 0.5 mg once daily or 3 days,~* 0.5 mg twice daily for 4 days~* 1.0 mg twice daily for 11 weeks

Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Double Blind Placebo
Description: For participants 16-17 years old, ≤ 55 kg:~* 0.5 mg once daily for 7 days, then~* 0.5 mg twice daily for 11 weeks~For participants 16-17 years old, \>55 kg:~* 0.5 mg once daily or 3 days,~* 0.5 mg twice daily for 4 days~* 1.0 mg twice daily for 11 weeks~For participants 18+ years old, regardless of weight:~* 0.5 mg once daily or 3 days,~* 0.5 mg twice daily for 4 days~* 1.0 mg twice daily for 11 weeks
Study: NCT05802056

Intervention type: PROCEDURE
Group type: EXPERIMENTAL
Intervention: Magnetic Resonance Imaging
Description: Undergo PET/MRI

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: Nivolumab
Description: Given IV

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Oxaliplatin
Description: Given IV

Intervention type: PROCEDURE
Group type: EXPERIMENTAL
Intervention: Positron Emission Tomography
Description: Undergo PET/CT or PET/MRI
Study: NCT06246799

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Tirzepatide
Description: Tirzepatide:Participants will be initiated on 2.5mg weekly and increase their dose to 5mg at week 4, 10mg at week 8 and 15mg at week 12 as tolerated.

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Tirzepatide
Description: Tirzepatide:Participants will be initiated on 2.5mg weekly and increase their dose to 5mg at week 4, 10mg at week 8 and 15mg at week 12 as tolerated.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Tirzepatide
Description: Tirzepatide:Participants will be initiated on 2.5mg weekly and increase their dose to 5mg at week 4, 10mg at week 8 and 15mg at week 12 as tolerated.

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Pioglitazone
Description: Pioglitazone: Participants will begin therapy at 15mg daily for the first 4 weeks then increase dose to 30mg at week 4 and to 45 mg at week 8, as tolerated.

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Pioglitazone
Description: Pioglitazone: Participants will begin therapy at 15mg daily for the first 4 weeks then increase dose to 30mg at week 4 and to 45 mg at week 8, as tolerated.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Pioglitazone
Description: Pioglitazone: Participants will begin therapy at 15mg daily for the first 4 weeks then increase dose to 30mg at week 4 and to 45 mg at week 8, as tolerated.

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Sitagliptin
Description: Sitagliptin: will be administered as a 100mg dose once daily.

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Metformin HCI XR
Description: Metformin will be administered at a dose of 1000mg for the first 4 weeks and then the dose increased to 2000mg.
Study: NCT05367492

Intervention type: BEHAVIORAL
Group type: PLACEBO_COMPARATOR
Intervention: QuitVaping
Description: QuitVaping is a manualized intervention based on the American Lung Association smoking cessation program modified with adolescent appropriate content and language for vaping cessation from the vaping section of teen.smokefree.gov and the Truth Initiative. These behavioral support sessions will be delivered weekly during the 12-week treatment phase via videoconference or in- person.

Intervention type: BEHAVIORAL
Group type: EXPERIMENTAL
Intervention: QuitVaping
Description: QuitVaping is a manualized intervention based on the American Lung Association smoking cessation program modified with adolescent appropriate content and language for vaping cessation from the vaping section of teen.smokefree.gov and the Truth Initiative. These behavioral support sessions will be delivered weekly during the 12-week treatment phase via videoconference or in- person.

Intervention type: BEHAVIORAL
Group type: PLACEBO_COMPARATOR
Intervention: This Is Quitting
Description: A free, publicly available text message vaping cessation program from Truth Initiative, designed specifically to help adolescents who vape nicotine quit. Participants who set a quit date receive messages for a week preceding it and 30 days afterward that include encouragement and support, skill- and self-efficacy building exercises, coping strategies, and information about the risks of vaping, benefits of quitting and cutting down to quit.

Intervention type: BEHAVIORAL
Group type: EXPERIMENTAL
Intervention: This Is Quitting
Description: A free, publicly available text message vaping cessation program from Truth Initiative, designed specifically to help adolescents who vape nicotine quit. Participants who set a quit date receive messages for a week preceding it and 30 days afterward that include encouragement and support, skill- and self-efficacy building exercises, coping strategies, and information about the risks of vaping, benefits of quitting and cutting down to quit.
Study: NCT05644769

Intervention type: OTHER
Group type: ACTIVE_COMPARATOR
Intervention: Determine the presence of Human sequence Ang-(1-12) on no medication
Description: Determine the presence of the human sequence of Ang-(1-12) in the plasma of ten normal male and female hypertensive patients on no medication.

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Human sequence Ang-(1-12) on Lisinopril 40mg every day
Description: Determine the presence of the human sequence of Ang-(1-12) in the plasma of 10 normal male and female hypertensive patients after four weeks on Lisinopril 40 mg every day.
Study: NCT05554588

Intervention type: PROCEDURE
Group type: ACTIVE_COMPARATOR
Intervention: Intrathrombus Thrombolysis During Primary PCI
Description: Intrathrombus Thrombolysis During Primary PCI

Intervention type: PROCEDURE
Group type: ACTIVE_COMPARATOR
Intervention: Aspiration Thrombectomy During Primary PCI
Description: Aspiration Thrombectomy During Primary PCI
Study: NCT05660538

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Pregabalin
Description: Capsules for oral administration.

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Placebo (matched to VX-548)
Description: Placebo matched to VX-548 for oral administration.
Study: NCT04815824

Intervention type: BEHAVIORAL
Group type: EXPERIMENTAL
Intervention: Exercise Mode
Description: Stationary cycling or treadmill walking

Intervention type: BEHAVIORAL
Group type: EXPERIMENTAL
Intervention: Exercise Mode
Description: Stationary cycling or treadmill walking
Study: NCT05895929

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Mepolizumab
Description: In vitro exposure of human nasal epithelial cells to mepolizumab
Study: NCT05660538

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Placebo (matched to pregabalin)
Description: Placebo matched to pregabalin for oral administration.
Study: NCT04938973

Intervention type: PROCEDURE
Group type: EXPERIMENTAL
Intervention: Robotic Assisted Minimally Invasive Esophagectomy (RAMIE)
Description: Robotic Assisted Minimally Invasive Esophagectomy (RAMIE) will be performed using the Da Vinci Robotic Surgical Platform.

Intervention type: PROCEDURE
Group type: ACTIVE_COMPARATOR
Intervention: Open Transthoracic Esophagectomy (OTE)
Description: Open Transthoracic Esophagectomy (OTE) is the current standard of care.

Intervention type: DEVICE
Group type: EXPERIMENTAL
Intervention: Robotic Assisted Minimally Invasive Esophagectomy (RAMIE)
Description: Robotic Assisted Minimally Invasive Esophagectomy (RAMIE) will be performed using the Da Vinci Robotic Surgical Platform.
Study: NCT04684680

Intervention type: DIETARY_SUPPLEMENT
Group type: EXPERIMENTAL
Intervention: zamzam water
Description: will receive the normal need of daily requirement of water (2.5 liter) in form of zamzam water till patients deliver or till term

Intervention type: DIETARY_SUPPLEMENT
Group type: ACTIVE_COMPARATOR
Intervention: tap water
Description: will receive the normal need of daily requirement of water (2.5 liter) in form of tap water
Study: NCT05722951

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Levetiracetam &/or sodium valproate
Description: levetiracetam \&/or sodium valproate will be given to 30 patients and monitored for 6 months

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Levetiracetam &/or sodium valproate
Description: levetiracetam \&/or sodium valproate will be given to 30 patients and monitored for 6 months

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Metformin
Description: metformin + (levetiracetam \&/or sodium valproate) will be given to 30 patients and monitored for 6 months will be given to 30 patients and monitored for 6 months
Study: NCT04697069

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: Imsidolimab
Description: Humanized monoclonal antibody

Intervention type: BIOLOGICAL
Group type: PLACEBO_COMPARATOR
Intervention: Placebo
Description: Placebo
Study: NCT04778410

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Magrolimab
Description: Administered intravenously

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Magrolimab
Description: Administered intravenously

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Magrolimab
Description: Administered intravenously

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Magrolimab
Description: Administered intravenously

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Magrolimab
Description: Administered intravenously

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Magrolimab
Description: Administered intravenously

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Azacitidine
Description: Administered either subcutaneously or IV, 75 mg/milligram per square (m\^2) on Days 1 to 7 or Days 1 to 5, 8 and 9 during every cycle

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Azacitidine
Description: Administered either subcutaneously or IV, 75 mg/milligram per square (m\^2) on Days 1 to 7 or Days 1 to 5, 8 and 9 during every cycle

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Venetoclax
Description: Administered orally at a dose of 100 mg on Day 1, 200 mg on Day 2, 400 mg on Days 3-28 during Cycle 1, followed by 400 mg on Days 1-28 during every cycle

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Venetoclax
Description: Administered orally at a dose of 100 mg on Day 1, 200 mg on Day 2, 400 mg on Days 3-28 during Cycle 1, followed by 400 mg on Days 1-28 during every cycle

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Mitoxantrone
Description: Administered intravenously, 8 mg/m\^2 on Days 1-5 during Cycle 1 to Cycle 3

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Mitoxantrone
Description: Administered intravenously, 8 mg/m\^2 on Days 1-5 during Cycle 1 to Cycle 3

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Etoposide
Description: Administered intravenously, 100 mg/m\^2 on Days 1-5 during Cycle 1 to Cycle 3

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Etoposide
Description: Administered intravenously, 100 mg/m\^2 on Days 1-5 during Cycle 1 to Cycle 3

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Cytarabine
Description: Administered intravenously, 1000 mg/m\^2 on Days 1-5 during Cycle 1 to Cycle 3

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Cytarabine
Description: Administered intravenously, 1000 mg/m\^2 on Days 1-5 during Cycle 1 to Cycle 3

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: CC-486
Description: Administered orally, 300 mg on Days 1-14 during each cycle

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: CC-486
Description: Administered orally, 300 mg on Days 1-14 during each cycle
Study: NCT06374056

Intervention type: DEVICE
Intervention: Kintsugi Voice Device
Description: The Kintsugi Voice Device is intended to be used to screen for the presence of voice signals consistent with a current moderate to severe depressive episode in patients aged 22 and older. The device is intended to be used by care providers licensed to screen for depression and in settings where the screening for depression occurs. The device is neither to be used in lieu of a complete patient evaluation nor to supplant any of the clinician's standard assessments for the screening or diagnosis of depression.~The Kintsugi Voice Device is comprised of a software API and machine learning model that utilizes recorded voice samples as inputs and outputs the detection of signals consistent with current moderate to severe depressive episode as outputs.
Study: NCT05629208

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Edecesertib
Description: Tablets administered orally

Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Edecesertib Placebo
Description: Tablets administered orally
Study: NCT06607003

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: P. vivax challenge agent derived from PvHMB-CCE001
Description: P. vivax challenge agent derived from PvHMB-CCE001 consists of infected and uninfected erythrocytes stabilized in glycerolyte. Challenge agent derived from this bank consists of thawed, washed, infected and uninfected erythrocytes suspended in injectable-grade normal saline.

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: P. vivax challenge agent derived from PvHMB-CCE001
Description: P. vivax challenge agent derived from PvHMB-CCE001 consists of infected and uninfected erythrocytes stabilized in glycerolyte. Challenge agent derived from this bank consists of thawed, washed, infected and uninfected erythrocytes suspended in injectable-grade normal saline.

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: P. vivax challenge agent derived from PvHMB-CCE002
Description: P. vivax challenge agent derived from PvHMB-CCE002 consists of infected and uninfected erythrocytes stabilized in glycerolyte. Challenge agent derived from this bank consists of thawed, washed, infected and uninfected erythrocytes suspended in injectable-grade normal saline.

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: P. vivax challenge agent derived from PvHMB-CCE002
Description: P. vivax challenge agent derived from PvHMB-CCE002 consists of infected and uninfected erythrocytes stabilized in glycerolyte. Challenge agent derived from this bank consists of thawed, washed, infected and uninfected erythrocytes suspended in injectable-grade normal saline.
Study: NCT04684342

Intervention type: DIAGNOSTIC_TEST
Group type: EXPERIMENTAL
Intervention: Routine Laboratory investigations
Description: 1. Complete blood picture~2. Liver function test and prothrombine time \& concentration.~3. Blood urea and creatinine~4. Blood glucose, serum Na and K~5. CRP and ESR~6. Clinical specimens will be collected from patients according to the suspected site of infection (e.g. blood, urine, ascitic fluid, sputum or endo- tracheal aspirates) VITEK 2Compact inflammatory markers
Study: NCT06664112

Intervention type: DEVICE
Intervention: AIDA Analysis
Description: The women will be followed until and after the birth, under intrapartum ultrasound monitoring, with all clinical, ultrasonographic and obstetric parameters, analyzed by AIDA method.
Study: NCT05852366

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Toothpaste Preparation
Description: Dentifrice for management of dentinal hypersensitivity

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Toothpaste Preparation
Description: Dentifrice for management of dentinal hypersensitivity

Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Toothpaste Preparation
Description: Dentifrice for management of dentinal hypersensitivity
Study: NCT06376604

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: Fasting Mimicking Diet
Description: Subject will consume 6 cycles of 5-day fasting mimicking diet: 3 days prior to, the day of, and 1 day following chemotherapy treatments.

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Chemotherapy
Description: 6 cycles of standard chemotherapy for the gynecologic malignancy.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Chemotherapy
Description: 6 cycles of standard chemotherapy for the gynecologic malignancy.
Study: NCT05826665

Intervention type: OTHER
Intervention: Persistent AF ablation assisted with the STAR Apollo Mapping System
Description: This exploratory hypothesis generating data set will be collected during standard AF ablation procedures using FDA cleared technologies as described in their Instructions for Use (IFU). No randomization or experimental protocols will be used during this study, and all follow up will be performed as per the center's standard of care(SOC).
Study: NCT06642896

Intervention type: DEVICE
Intervention: pupillometer
Description: describe the feasibility of pupillometry measurements in sedated but non-cerebrosed children

Intervention type: DEVICE
Intervention: pupillometer
Description: Pupillometry measurements at 5 and 25 minutes for children treated with osmotherapy, followed by measurements twice a day during hospitalization in the intensive care unit
Study: NCT05352477

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: Balneotherapy with thermal water
Description: Bath with Acquabios thermal water at 33°C, 20 minutes daily for a total of 12 days, 6 days a week (from Monday to Saturday, Sundays excluded)

Intervention type: OTHER
Group type: PLACEBO_COMPARATOR
Intervention: Balneotherapy with tap water
Description: Bath with tap water at 33°C, 20 minutes daily for a total of 12 days, 6 days a week (from Monday to Saturday, Sundays excluded)
Study: NCT05610449

Intervention type: DIAGNOSTIC_TEST
Intervention: Testing Done Simple SARS CoV-2 Antigen Test
Description: Collections of specimens from subjects presenting with Covid-19 like symptoms or known/suspected exposure to SARS CoV-2 via nasal swabs administered by trained medical personnel.

Intervention type: DIAGNOSTIC_TEST
Intervention: Testing Done Simple SARS CoV-2 Antigen Test
Description: Collections of specimens from subjects presenting with Covid-19 like symptoms or known/suspected exposure to SARS CoV-2 via nasal swabs administered by trained medical personnel.
Study: NCT05376137

Intervention type: DEVICE
Group type: ACTIVE_COMPARATOR
Intervention: continuous positive airway pressure (CPAP)
Description: CPAP comfort settings will be modified in the active group to be personalized to each participant

Intervention type: DEVICE
Group type: EXPERIMENTAL
Intervention: continuous positive airway pressure (CPAP)
Description: CPAP comfort settings will be modified in the active group to be personalized to each participant
Study: NCT06034847

Intervention type: DEVICE
Group type: ACTIVE_COMPARATOR
Intervention: Mechanical thrombectomy in proximal large vessels
Description: mechanical thrombectomy with retrievable stents to remove clots in proximal large vessels, combined or not with distal aspiration, combined or not with IV thrombolytics

Intervention type: DEVICE
Group type: ACTIVE_COMPARATOR
Intervention: Mechanical thrombectomy in proximal large vessels
Description: mechanical thrombectomy with retrievable stents to remove clots in proximal large vessels, combined or not with distal aspiration, combined or not with IV thrombolytics
Study: NCT06498739

Intervention type: DRUG
Group type: OTHER
Intervention: Erector spinae plane block(15 ml bupivacaine 0.5%)
Description: Patients will preoperatively receive high concentration-low volume ultrasound guided Erector Spinae Plane block, and then the patient will be transferred to the operating room (one syringe of 15 ml bupivacaine 0.5% {15 ml bupivacaine 0.5% }, for each patient).

Intervention type: DRUG
Group type: OTHER
Intervention: Erector spinae plane block (15 ml bupivacaine 0.5% and 15ml normal saline)
Description: Patients will preoperatively receive low concentration-high volume ultrasound guided Erector Spinae Plane block, and then the patient will be transferred to the operating room ) one syringe of 30ml bupivacaine 0.25% {15 ml bupivacaine 0.5% and 15ml normal saline}, for each patient.
Study: NCT06637969

Intervention type: BEHAVIORAL
Group type: EXPERIMENTAL
Intervention: mindfulness-based
Description: The experimental group was also provided with a total of 30 minutes of mindfulness training once a day for seven consecutive days. The content included mindful breathing awareness for 8 minutes while resting and lying in bed, 10 minutes of mindfulness meditation, 12 minutes of mindfulness body scanning, and 10 minutes of mindful walking and breathing. The control group The group received routine care, and a pre-test was conducted before the implementation of the interventional measures (from 7 pm to 9 pm the day before the operation), and a post-test was conducted after the seven-day intervention (from 7 pm to 9 pm on the seventh day of the interventional treatment). Comparison between the experimental group and the control group group differences