TrialPanorama/TrialPanorama-database huggingface dataset:
Study: NCT06018584

Intervention type: OTHER
Group type: SHAM_COMPARATOR
Intervention: Tooth extraction
Description: Tooth extractions were performed by a single physician. Topical anesthesia (Xylo-caine, Astra, Södertalje, Switzerland) was applied to the dried mucosa in the area to be lo-calized with the help of an ear stick for 1 minute. Posterior-superior-alveolar nerve block anesthesia and palatal anesthesia were applied for the upper primary molars; Inferi-or-alveolar nerve block anesthesia and lingual anesthesia (Ultracain, Aventis Pharma, Is-tanbul, Turkey) were applied for the lower primary molars. After anesthesia control was achieved, a randomly selected tooth was extracted. Tooth extraction on the other side was performed two weeks later. During the shootings, attention was paid to the traumatic ap-proach. After the control of bleeding was achieved, data were recorded for each group.
Study: NCT02221700

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: Quality-of-Life Assessment
Description: Ancillary studies

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: Questionnaire Administration
Description: Ancillary studies

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: Questionnaire Administration
Description: Ancillary studies

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: Questionnaire Administration
Description: Ancillary studies

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: Questionnaire Administration
Description: Ancillary studies
Study: NCT05753917

Intervention type: DEVICE
Group type: EXPERIMENTAL
Intervention: Piezo-surgery insert OR Conventional Drills
Description: piezo-surgery: Group A (piezoelectric device with IM1, IM2, IM2-3, or IM3 piezo-inserts according to the manufacturer's protocol (Piezosurgery, Mectron Medical Technology, Carasco, Italy) Conventional drill: Group B (conventional drills according to the manufacturer's protocol (Premium, Sweden \& Martina, Due Carrare, Padova, Italy)

Intervention type: DEVICE
Group type: ACTIVE_COMPARATOR
Intervention: Piezo-surgery insert OR Conventional Drills
Description: piezo-surgery: Group A (piezoelectric device with IM1, IM2, IM2-3, or IM3 piezo-inserts according to the manufacturer's protocol (Piezosurgery, Mectron Medical Technology, Carasco, Italy) Conventional drill: Group B (conventional drills according to the manufacturer's protocol (Premium, Sweden \& Martina, Due Carrare, Padova, Italy)
Study: NCT02019706

Intervention type: RADIATION
Group type: EXPERIMENTAL
Intervention: DOTATATE PET-CT
Description: 68Ga-DOTATATE PET/CT

Intervention type: RADIATION
Group type: EXPERIMENTAL
Intervention: F-DOPA PET CT
Description: 68Ga-DOTATATE PET/CT

Intervention type: RADIATION
Group type: EXPERIMENTAL
Intervention: CT scan
Description: routine CT scan

Intervention type: DIAGNOSTIC_TEST
Group type: EXPERIMENTAL
Intervention: Routine MRI scan
Description: routine 1.5 or 3T MRI scan

Intervention type: DIAGNOSTIC_TEST
Group type: EXPERIMENTAL
Intervention: Gated MRI scan
Description: Cardiac gated MRI scan

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: 68Ga-DOTATATE
Description: 68Ga-DOTATATE radioligand

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: 18F-DOPA
Description: 18F-DOPA radioligand
Study: NCT03242434

Intervention type: OTHER
Group type: OTHER
Intervention: Lactulose and Mannitol solution
Description: Participants will receive 100 milliliter (mL) oral solution of Lactulose \[5 grams (g)\]/ Mannitol (2g), a non-investigational medicinal product, by oral route to measure intestinal permeability.

Intervention type: OTHER
Group type: OTHER
Intervention: Lactulose and Mannitol solution
Description: Participants will receive 100 milliliter (mL) oral solution of Lactulose \[5 grams (g)\]/ Mannitol (2g), a non-investigational medicinal product, by oral route to measure intestinal permeability.

Intervention type: OTHER
Group type: OTHER
Intervention: Sucralose
Description: Participants will receive 3 capsules of Sucralose (2g), a non-investigational medicinal product, by oral route to measure intestinal permeability.

Intervention type: OTHER
Group type: OTHER
Intervention: Sucralose
Description: Participants will receive 3 capsules of Sucralose (2g), a non-investigational medicinal product, by oral route to measure intestinal permeability.
Study: NCT00520338

Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: celecoxib
Description: 1. placebo~2. celecoxib 400 mg oral single dose
Study: NCT02071589

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Nifedipine soft gelatine capsules
Description: 3 Adalat capsules of 10 mg each one

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Nifedipine oral solution
Description: 6 mL of Nife Par solution
Study: NCT02228928

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: CAPNP, 50 ug/cm2 capsaicin patch

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: CAPNP, 100 ug/cm2 capsaicin patch

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: 0.075% capsaicin cream

Intervention type: OTHER
Group type: PLACEBO_COMPARATOR
Intervention: Placebo patch
Study: NCT03862417

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: Schroth exercises
Description: An exercise program begun individually and then continued in groups.
Study: NCT01505855

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: 23-valent polysaccharide pneumococcal vaccine
Description: 23-valent polysaccharide pneumococcal vaccine (PSV-23 vaccine) 0.5mL single intramuscular injection
Study: NCT03458143

Intervention type: DRUG
Intervention: Remifentanil
Description: conscious sedation in TCI-mode

Intervention type: DRUG
Intervention: Remifentanil
Description: conscious sedation in TCI-mode

Intervention type: PROCEDURE
Intervention: Oocyte retrieval
Description: Oocyte retrieval for In Vitro Fertilization

Intervention type: PROCEDURE
Intervention: Oocyte retrieval
Description: Oocyte retrieval for In Vitro Fertilization

Intervention type: DRUG
Intervention: Ketamine 200 ng/ml
Description: conscious sedation in TCI-mode
Study: NCT05425342

Intervention type: DEVICE
Group type: EXPERIMENTAL
Intervention: Smartwatch ECG
Description: Self-recorded 9-lead smartwatch ECGs
Study: NCT01505855

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: 23-valent polysaccharide pneumococcal vaccine
Description: 23-valent polysaccharide pneumococcal vaccine (PSV-23 vaccine) 0.5mL single intramuscular injection

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: 23-valent polysaccharide pneumococcal vaccine
Description: 23-valent polysaccharide pneumococcal vaccine (PSV-23 vaccine) 0.5mL single intramuscular injection
Study: NCT03460574

Intervention type: BEHAVIORAL
Group type: EXPERIMENTAL
Intervention: INFORMATION
Description: After receiving expectation-disconfirming positive performance feedback, participants receive standardized information that stresses the relevance of this experience. In particular, participants are told that the performance test they worked on is highly relevant for both professional success and personal life satisfaction.

Intervention type: BEHAVIORAL
Group type: EXPERIMENTAL
Intervention: SALIENCE
Description: After receiving expectation-disconfirming positive performance feedback, partcipants in this condition are instructed to remember how well they performed on the performance test. Using a visual analogue scale, they were asked to specify how they performed relative to the other participants.

Intervention type: BEHAVIORAL
Group type: EXPERIMENTAL
Intervention: ATTENTION
Description: Before working on the performance test, participants are instructed to pay attention to the feedback they receive. In particular, they are asked to enter what would be a personally good result for them. It is supposed that this shift of attention increases the salience of the expectation-disconfirming feedback.

Intervention type: BEHAVIORAL
Group type: EXPERIMENTAL
Intervention: CONTROL
Description: This group does not receive any further intervention. Instead, participants of this group pass through the standard procedure of the EXPEC paradigm.
Study: NCT04172844

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Azacitidine
Description: 75mg/m\^2 Days 1-7 given IV

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Azacitidine
Description: 75mg/m\^2 Days 1-7 given IV

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Venetoclax
Description: 100 mg on cycle 1 day 1, 200 mg daily on cycle 1 day 2, 400 mg on cycle 1 day 3 and thereafter from cycle 1. Venetoclax is given for a minimum of 21 days and a maximum of 28 days. Administered orally.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Venetoclax
Description: 100 mg on cycle 1 day 1, 200 mg daily on cycle 1 day 2, 400 mg on cycle 1 day 3 and thereafter from cycle 1. Venetoclax is given for a minimum of 21 days and a maximum of 28 days. Administered orally.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Pevonedistat
Description: The doses for the 3 + 3 design (dose escalation phase) are listed in the arm description. The dose-expansion phase will use the maximum-tolerated dose.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Pevonedistat
Description: The doses for the 3 + 3 design (dose escalation phase) are listed in the arm description. The dose-expansion phase will use the maximum-tolerated dose.
Study: NCT00015457

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Amlodipine plus Botulinum toxin
Study: NCT01168453

Intervention type: BEHAVIORAL
Intervention: head position change
Description: AL-US distance measure using the ultrasound in two different head position

Intervention type: BEHAVIORAL
Intervention: head position change
Description: AL-US distance measure using the ultrasound in two different head position
Study: NCT01526603

Intervention type: DRUG
Group type: OTHER
Intervention: Carboplatin
Description: Carboplatin intravenously (IV), 425 mg/m2/dose (or if ≤ 12kg, 14.2 mg/kg/dose) once daily x 4 doses on days 7 through 4 pretransplant.

Intervention type: BIOLOGICAL
Group type: OTHER
Intervention: Autologous stem cell infusion
Description: On day 0 the stem cells will be infused immediately after thawing over 15-60 minutes per institutional guidelines.

Intervention type: BIOLOGICAL
Group type: OTHER
Intervention: Granulocyte colony stimulating factor
Description: Beginning on day 0 after infusion of the PBSC, patients will receive G-CSF subcutaneously (SQ) or IV (SQ preferred) 5 micrograms/kg once daily and continuing once daily until post-nadir absolute neutrophil count (ANC) \> 2000/μL for 3 consecutive days.

Intervention type: RADIATION
Group type: OTHER
Intervention: Radiation therapy
Description: It is suggested that patients who have a complete surgical resection of the primary tumor receive 21.6 Gy external beam radiation therapy (EBRT) to the post-induction chemotherapy, pre-operative primary tumor volume. It is suggested that patients who have an incomplete surgical resection of the primary tumor (residual soft tissue mass measuring \>1 cm3) will receive 21.6 Gy EBRT to the postinduction chemotherapy, pre-operative primary tumor volume and an additional boost of 14.4 Gy EBRT to the gross residual tumor (total dose 36 Gy to gross residual tumor volume). Radiation should be given after stem cell transplantation and should start no sooner than 28 days post transplant.

Intervention type: DRUG
Group type: OTHER
Intervention: Isotretinoin (13-cis-retinoic acid)
Description: Post-transplant maintenance therapy with cis-RA daily for 14 days every 28 days repeated for 6 months. This phase of the therapy can be initiated by the BMT team and continued by the referring physician. It is recommended to begin Isotretinoin at day 66 post-transplant and no later than day 100. For patients ≤12 kg, isotretinoin (accutane) should be administered at 5.33 mg/kg/dose divided twice daily. For patients \>12 kg isotretinoin (accutane) should be administered at 160 mg/m\^2/day divided twice a day. Patients should be considered for monoclonal antibody therapy against GD2, such as ch14.18 if such trials are available.

Intervention type: DRUG
Group type: OTHER
Intervention: Melphalan
Description: Melphalan Intravenously (IV), 70 mg/m2/dose (or if ≤ 12 kg, 2.3 mg/kg/dose) once daily x 3 doses on days 7 through 5 pretransplant

Intervention type: DRUG
Group type: OTHER
Intervention: Etoposide
Description: Etoposide intravenously (IV), 338 mg/m2/dose (or if ≤ 12kg, 11.3 mg/kg/dose) once daily x 4 doses on days 7 through 4 pretransplant
Study: NCT04584021

Intervention type: DEVICE
Intervention: Xiaomi MiBand3
Description: Recording of sleep, activity and heart rate data to study their association with stress.

Intervention type: OTHER
Intervention: Socio-demographic questionnaire
Description: Self-made questionnaire to be filled by the participants at the beginning of the study with the following personal data: age, gender, marital status, residential environment, cohabitation unit, educational level, socio-economic level, contract, working hours, overtime or not, number of overtime hours in a day, overtime frequency and perceived stress level

Intervention type: OTHER
Intervention: EuroQol-5D-5L
Description: Quality of life questionnaire to be filled by the participants at the beginning, mid-term and completion of the study with the following information: severity index, social value index for each health condition. Subjective evaluation of health status from 0 to 100.

Intervention type: OTHER
Intervention: Pittsburgh Sleep Quality Index (PSQI)
Description: Questionnaire to be filled by the participants whose outcome is the perceived quality, quantity and efficient of sleep. To be given at the beginning, mid-term, and completion of the study.

Intervention type: OTHER
Intervention: State-Trait Anxiety Inventory (STAI)
Description: Questionnaire to be filled by the participants which measures the anxiety level. To be given at the beginning, mid-term and completion of the study.

Intervention type: OTHER
Intervention: Perceived Stress Scale-10 (PSS-10)
Description: Questionnaire to be filled by the participants which measures the stress level. To be given at the beginning, mid-term and completion of the study.

Intervention type: OTHER
Intervention: Stress questionnaire
Description: Questionnaire designed by a work stress psychologist professional from the research group which is focused on stress and daily functioning. This questionnaire was given for the participants to fill. It is composed by 3 daily items and 4 weekly items.
Study: NCT04776486

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Iohexol
Description: Intravenous injection of 5 ml of iohexol (Omnipaque) to calculate the glomerular filtration rate (area under the curve).~Blood samples (2 ml) and urine (2 ml minimum) are to be collected for the determination of iohexol clearance at the following time points: pre-dose, 5 minutes, and 1, 2, 3, 4, 5, 6 hours post dose.
Study: NCT02954055

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Paclitaxel
Description: Arm A

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Cyclophosphamide
Description: Arm B

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Capecitabine
Description: Arm B

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Vinorelbine
Description: Arm B
Study: NCT03767764

Intervention type: DIAGNOSTIC_TEST
Intervention: Test Yliver
Description: Test Yliver is used to detect autoantibodies against alpha fetoprotein in serum by an ELISA technique

Intervention type: DIAGNOSTIC_TEST
Intervention: Test Yliver
Description: Test Yliver is used to detect autoantibodies against alpha fetoprotein in serum by an ELISA technique
Study: NCT00757679

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Milnacipran
Description: capsules

Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Placebo
Description: capsules
Study: NCT02949570

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Inecalcitol
Description: Prospective open label, non-comparative, multicentre exploratory study. Divided in 2 parts Part1: Inecalcitol treatment will be added to imatinib for 12 months. Part 2: Follow-up after discontinuation of inecalcitol. Imatinib will be maintained for 2 years and then will be stopped for those still in MR4.5. These patients will then be followed for 2 additional years after discontinuation of imatinib.
Study: NCT02690103

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: pegylated IFN
Description: Patients are treated with 180µg of pegylated IFN (Pegasys-Roche) subcutaneously weekly for three months.

Intervention type: DIETARY_SUPPLEMENT
Group type: EXPERIMENTAL
Intervention: Biobran
Description: Biobran, at a dose of 1g per day, allocated in packets, taken orally with meals for the three months duration of the study. Biobran is a denatured hemicellulose that is obtained by reacting rice bran hemicellulose with multiple carbohydrate hydrolyzing enzymes from Shiitake mushrooms. It is a polysaccharide that contains ß-1, 3-glucans, and activated hemicellulose. Biobran was kindly provided by Daiwa Pharmaceuticals Co. Ltd., Tokyo, Japan.

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Ribavirin
Description: Ribavirin is prescribed according to patients body weight (1200 mg for those over 75 kg and 1000 mg for those under 75 kg).
Study: NCT01872624

Intervention type: PROCEDURE
Group type: ACTIVE_COMPARATOR
Intervention: Bronchoscopy
Description: Bronchoscopic delivery of one-way valves and bone-marrow derived mesenchymal stromal cells.

Intervention type: PROCEDURE
Group type: PLACEBO_COMPARATOR
Intervention: Bronchoscopy
Description: Bronchoscopic delivery of one-way valves and bone-marrow derived mesenchymal stromal cells.
Study: NCT04148105

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Cilostazol 100 MG
Description: The addition of 100 mg cilostazol, twice daily for 14 days, to the standard treatment regimen of 60 mg nimodipine every 4 hours for 21 days and the standard aneurysmal subarachnoid treatment pathway

Intervention type: OTHER
Group type: PLACEBO_COMPARATOR
Intervention: Placebo
Description: The standard treatment regimen of 60 mg nimodipine every 4 hours for 21 days and the standard aneurysmal subarachnoid treatment pathway
Study: NCT04314843

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Cyclophosphamide
Description: Administered according to package insert

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Fludarabine
Description: Administered according to package insert

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: Lenzilumab
Description: Administered as an IV infusion

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: Axicabtagene Ciloleucel
Description: A single infusion of chimeric antigen receptor (CAR) transduced autologous T cells administered intravenously.
Study: NCT06018584

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: Tooth extraction
Description: Tooth extractions were performed by a single physician. Topical anesthesia (Xylo-caine, Astra, Södertalje, Switzerland) was applied to the dried mucosa in the area to be lo-calized with the help of an ear stick for 1 minute. Posterior-superior-alveolar nerve block anesthesia and palatal anesthesia were applied for the upper primary molars; Inferi-or-alveolar nerve block anesthesia and lingual anesthesia (Ultracain, Aventis Pharma, Is-tanbul, Turkey) were applied for the lower primary molars. After anesthesia control was achieved, a randomly selected tooth was extracted. Tooth extraction on the other side was performed two weeks later. During the shootings, attention was paid to the traumatic ap-proach. After the control of bleeding was achieved, data were recorded for each group.
Study: NCT01058369

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Deferasirox (Novartis Pharma)
Description: Treatment period 102 weeks. Starting dose 10mg/kg/day. Up to 30/mg/kg according to dose adjustment table as specified in the protocol
Study: NCT01914016

Intervention type: OTHER
Group type: OTHER
Intervention: prolonged walk
Description: Participants will be asked to walk for a duration of between 2 -6 minutes until they rate their perceived exertion as 'Hard' (RPE 16 on Borg Scale)
Study: NCT06600750

Intervention type: PROCEDURE
Intervention: Arteriovenous fistula
Description: Patients who underwent Radiocephalic arteriovenous fistula surgery
Study: NCT00732888

Intervention type: DRUG
Group type: OTHER
Intervention: Nilotinib Hydrochloride
Description: Dosage form: capsules Dosage: 400 mg (2 x 200 mg capsule) Frequency \& duration: On an 18-day schedule, one dose administered once on day 1 and once on day 15 (2 doses total)

Intervention type: DRUG
Group type: OTHER
Intervention: Nilotinib Hydrochloride
Description: Dosage form: capsules Dosage: 400 mg (2 x 200 mg capsule) Frequency \& duration: On an 18-day schedule, one dose administered once on day 1 and once on day 15 (2 doses total)

Intervention type: DIETARY_SUPPLEMENT
Group type: OTHER
Intervention: calcium carbonate
Description: Dosage form: tablets Dosage: 4000 mg (4 x 1000 mg tablet) Frequency: On an 18-day schedule, once daily day 15 (for Arm 1); or once daily day 1 (for Arm 2)

Intervention type: DIETARY_SUPPLEMENT
Group type: OTHER
Intervention: calcium carbonate
Description: Dosage form: tablets Dosage: 4000 mg (4 x 1000 mg tablet) Frequency: On an 18-day schedule, once daily day 15 (for Arm 1); or once daily day 1 (for Arm 2)
Study: NCT04250792

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Naltrexone Pill
Description: role of low dose naltrexone in patients affected with psoriasis
Study: NCT03308357

Intervention type: DIAGNOSTIC_TEST
Intervention: Drug assays to measure infliximab
Description: See protocol
Study: NCT03716596

Intervention type: RADIATION
Group type: EXPERIMENTAL
Intervention: SBRT
Description: SBRT radiation dose is 40-50 Gy in total.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: anti-PD-1 antibody
Description: Intravenous drug of anti-PD-1 antibody, 200mg, once a time, every three weeks.
Study: NCT03201809

Intervention type: DEVICE
Group type: EXPERIMENTAL
Intervention: On-Q
Description: 0.2% Ropivicaine at 4 mL/h via On-Q catheter placed sub-pectoral

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Ultrasound guided pectoral nerve block
Description: Single Shot Pre-operative injections of 10 mL of 0.25% Ropivicaine for the Pecs 1 injection, and 20 mL of 0.25% Ropivacaine for the Pecs 2 injection
Study: NCT01597700

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: 10mg Ezetimibe
Description: 1 tablet taken by mouth

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: 10 mg Ezetimibe - wash out period
Description: 1 tablet taken by mouth received after wash out period
Study: NCT01398930

Intervention type: OTHER
Group type: ACTIVE_COMPARATOR
Intervention: acupuncture
Description: This is a 3-armed single-blinded randomized sham-controlled trial, comparing acupuncture along with pharmacological treatment, sham acupuncture including pharmacological treatment, and pharmacological treatment alone.

Intervention type: OTHER
Group type: ACTIVE_COMPARATOR
Intervention: acupuncture
Description: This is a 3-armed single-blinded randomized sham-controlled trial, comparing acupuncture along with pharmacological treatment, sham acupuncture including pharmacological treatment, and pharmacological treatment alone.

Intervention type: OTHER
Group type: SHAM_COMPARATOR
Intervention: acupuncture
Description: This is a 3-armed single-blinded randomized sham-controlled trial, comparing acupuncture along with pharmacological treatment, sham acupuncture including pharmacological treatment, and pharmacological treatment alone.