TrialPanorama/TrialPanorama-database huggingface dataset:
Study: NCT02674412

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Buspirone

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Buspirone

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Placebo
Description: Placebo Pill Manufactured by the Investigational Pharmacy at Cleveland Clinic

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Placebo
Description: Placebo Pill Manufactured by the Investigational Pharmacy at Cleveland Clinic
Study: NCT00698269

Intervention type: DRUG
Intervention: insulin detemir
Description: Start dose and frequency to be prescribed by the physician as a result of the normal clinical evaluation

Intervention type: DRUG
Intervention: biphasic insulin aspart 30
Description: Start dose and frequency to be prescribed by the physician as a result of the normal clinical evaluation

Intervention type: DRUG
Intervention: insulin aspart
Description: Start dose and frequency to be prescribed by the physician as a result of the normal clinical evaluation
Study: NCT03535220

Intervention type: COMBINATION_PRODUCT
Intervention: Protease Inhibitors
Description: Nucleic Acid Synthesis Inhibitors,Hydroxyurea,Antineoplastic Agents
Study: NCT02376192

Intervention type: DEVICE
Group type: EXPERIMENTAL
Intervention: Initial MicroScan® (Microvision Medical) SDF Measurement
Description: Initial SDF measurements are recorded in the obstetric preoperative area within two hours prior to administration of spinal anesthesia.

Intervention type: DEVICE
Group type: EXPERIMENTAL
Intervention: Initial MicroScan® (Microvision Medical) SDF Measurement
Description: Initial SDF measurements are recorded in the obstetric preoperative area within two hours prior to administration of spinal anesthesia.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Spinal Anesthesia- Bupivacaine
Description: The spinal anesthetic technique is standardized. In the operating room spinal anesthesia will be administered with the L2-L5 interspaces in the sitting position using 12 mg of hyperbaric bupivacaine with 15 mcg of fentanyl and 150 mcg of preservative free morphine.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Spinal Anesthesia- Bupivacaine
Description: The spinal anesthetic technique is standardized. In the operating room spinal anesthesia will be administered with the L2-L5 interspaces in the sitting position using 12 mg of hyperbaric bupivacaine with 15 mcg of fentanyl and 150 mcg of preservative free morphine.

Intervention type: DEVICE
Group type: EXPERIMENTAL
Intervention: Comparative MicroScan® (Microvision Medical) SDF Measurement
Description: A second comparative SDF measurement be recorded within 10 minutes after induction of spinal anesthesia.

Intervention type: DEVICE
Group type: EXPERIMENTAL
Intervention: Comparative MicroScan® (Microvision Medical) SDF Measurement
Description: A second comparative SDF measurement be recorded within 10 minutes after induction of spinal anesthesia.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Bolus Phenylephrine/Ephedrine Treatment
Description: Participants who experience hypotension following induction of spinal anesthesia will be treated with a bolus of phenylephrine and/or ephedrine as needed.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Phenylephrine Infusion
Description: Participants will have an infusion of phenylephrine started immediately following the induction of spinal anesthesia for prevention of hypotension.
Study: NCT00876473

Intervention type: PROCEDURE
Intervention: CPAP system
Description: Evaluating the effects of different CPAP systems on respiratory mechanics, respiratory effort and gas-exchange~CPAP systems:~Continuous high-flow CPAP with fixed value PEEP valve~Continuous high-flow CPAP with Boussignac valve~Demand flow CPAP supplied by ventilator
Study: NCT01320683

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: leucovorin calcium
Description: Given IV

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

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: bevacizumab
Description: Given IV
Study: NCT03466502

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Oral Vancomycin
Description: Oral vancomycin will be given concurrently with antibiotics to hospitalized patients with a history of Clostridium difficile infection to prevent recurrence

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Oral Vancomycin
Description: Oral vancomycin will be given concurrently with antibiotics to hospitalized patients with a history of Clostridium difficile infection to prevent recurrence
Study: NCT03789552

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: T89 capsule
Description: T89 capsules (75mg)

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: T89 capsule
Description: T89 capsules (75mg)

Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Placebo capsule
Description: Placebo capsules (0mg)

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Placebo capsule
Description: Placebo capsules (0mg)
Study: NCT00712088

Intervention type: BEHAVIORAL
Group type: EXPERIMENTAL
Intervention: Project ICARE
Description: Group-level intervention (Project ICARE)

Intervention type: BEHAVIORAL
Group type: ACTIVE_COMPARATOR
Intervention: HCT
Description: Offer of HIV counseling and testing
Study: NCT03801616

Intervention type: DEVICE
Group type: EXPERIMENTAL
Intervention: Virtual Reality
Description: Virtual Reality in controlling pain
Study: NCT00847496

Intervention type: DEVICE
Group type: EXPERIMENTAL
Intervention: AWBAT
Description: One-time application of dressing over partial-thickness burns

Intervention type: DEVICE
Group type: ACTIVE_COMPARATOR
Intervention: Biobrane
Description: One-time application over partial-thickness burns
Study: NCT04508569

Intervention type: BEHAVIORAL
Group type: EXPERIMENTAL
Intervention: Big Decisions
Description: Big Decisions is a promising teen pregnancy prevention intervention that consists primarily of abstinence-plus sexual health education curriculum. The intended dosage for students is 10 classroom-based sexual health lessons.

Intervention type: BEHAVIORAL
Group type: ACTIVE_COMPARATOR
Intervention: Big Decisions
Description: Big Decisions is a promising teen pregnancy prevention intervention that consists primarily of abstinence-plus sexual health education curriculum. The intended dosage for students is 10 classroom-based sexual health lessons.
Study: NCT01921829

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Protocolized Diuretic Strategy
Description: The Protocolized Diuretic Strategy will administer diuretics according to an algorithm based on based on the stepped pharmacologic care arm used by the CARRESS-HF trial investigators. This algorithm targets a relatively aggressive goal diuresis of urine output (UO) 3-5 L/day with diuretics intensified in a stepped fashion using both loop diuretics given by intravenous (IV) bolus followed by IV continuous infusion (furosemide or alternative loop diuretic at equivalent dose), with or without concomitant thiazide diuretic (oral (PO) metolazone or IV chlorothiazide).
Study: NCT04385602

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Intratracheal dexmedetomidine
Description: Thirty minutes before the end of the surgery, Dex (0.5μg/kg diluted and mixed in 1ml saline in a medical spray bottle) will be sprayed down the intratracheal tube

Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Saline Solution
Description: Thirty minutes before the end of the surgery, 1ml saline in a medical spray bottle will be sprayed down the intratracheal tube
Study: NCT01200693

Intervention type: DEVICE
Group type: ACTIVE_COMPARATOR
Intervention: Zotarolimus eluting stent
Description: Implantation of Zotarolimus eluting stent
Study: NCT03826342

Intervention type: BEHAVIORAL
Group type: EXPERIMENTAL
Intervention: Health Check-up for Expectant Moms
Description: A brief intervention (one session plus two booster sessions)

Intervention type: BEHAVIORAL
Group type: ACTIVE_COMPARATOR
Intervention: Time, attention, and information-matched control
Description: We will include facts about alcohol/drug use and risky sex during pregnancy, along with informational brochures that provide face validity.
Study: NCT04355078

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: Neuromuscular Training
Description: Muscular and neural training by complex exercises

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: Strength Training
Description: Strength Training
Study: NCT02353182

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Dexmedetomidine
Description: Loading dose:1 mcg/kg over 10 minutes. Infusion: Start 1-1.5 mcg/kg/hr. Titrate up or down within 50% of starting doses as needed.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Remifentanil
Description: Loading dose: 1 mcg/kg over 1-2 minutes. Infusion: Start at 0.2-0.5 mcg/kg/min. Titrate up or down (max 0.5 mcg/kg/min) as needed.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Bupivacaine
Description: Administered in caudal/epidural/field block: 0.175%-0.25% (dose at discretion of anaesthetist)
Study: NCT04476030

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: SAGE-217
Description: Oral capsules
Study: NCT01320683

Intervention type: RADIATION
Group type: EXPERIMENTAL
Intervention: yttrium Y 90 DOTA anti-CEA monoclonal antibody M5A
Description: Given IV

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: laboratory biomarker analysis
Description: Correlative studies

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: pharmacological study
Description: Correlative studies

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: irinotecan hydrochloride
Description: Given IV
Study: NCT04476030

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Matching Placebo
Description: Oral capsules

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Sertraline
Description: Oral tablets

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Sertraline
Description: Oral tablets

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Escitalopram
Description: Oral tablets

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Escitalopram
Description: Oral tablets

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Citalopram
Description: Oral tablets

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Citalopram
Description: Oral tablets

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Duloxetine
Description: Oral capsules

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Duloxetine
Description: Oral capsules

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Desvenlafaxine
Description: Oral tablets

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Desvenlafaxine
Description: Oral tablets
Study: NCT02040662

Intervention type: PROCEDURE
Group type: EXPERIMENTAL
Intervention: Continuous Thoracic Epidural Block
Description: Before anesthesia, continuous thoracic epidural block of T5/T6 is performed (Portex Epidural Minipack set). Identification of paravertebral space by loss of resistance technique (air). A catheter is advanced ca. 3-5 cm, and test dose with 2 ml of lidocaine 2% i injected. At the end of surgery syringe with 0,25% bupivacaine with epinephrine 1:200.000 is connected to catheter and 6 ml bolus is injected, followed by an infusion of the same mixture at 0,06 ml/kg/h for postoperative pain management.

Intervention type: PROCEDURE
Group type: EXPERIMENTAL
Intervention: Continuous Thoracic Paravertebral Block
Description: Before anesthesia, continuous thoracic paravertebral block of T5/T6 is performed (Portex Epidural Minipack set). Identification of paravertebral space by loss of resistance technique (normal saline). After injection of 5-10 ml of normal saline a catheter is advanced medially ca. 5 cm. At the end of surgery syringe with 0,25% bupivacaine with epinephrine 1:200.000 is connected to catheter and 20 ml bolus is injected, followed by an infusion of the same mixture at 0,08 ml/kg/h for postoperative pain management

Intervention type: PROCEDURE
Group type: EXPERIMENTAL
Intervention: Patient-Controlled Analgesia with Morphine
Description: Once arrived at the PACU all patients are placed on a postoperative analgesia regimen, that include:~* patient-controlled analgesia with morphine (bolus dose 2 mg, lockout time 10 min)~* paracetamol 1000 mg iv every 8 hrs~* ketoprofen 100 mg iv every 12 hrs

Intervention type: PROCEDURE
Group type: EXPERIMENTAL
Intervention: Patient-Controlled Analgesia with Morphine
Description: Once arrived at the PACU all patients are placed on a postoperative analgesia regimen, that include:~* patient-controlled analgesia with morphine (bolus dose 2 mg, lockout time 10 min)~* paracetamol 1000 mg iv every 8 hrs~* ketoprofen 100 mg iv every 12 hrs
Study: NCT01410734

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Indocyanine green (ICG)
Description: 2.5mg indocyanine green (ICG) will be administerly (IV injection) 30 minutes before surgery
Study: NCT03228810

Intervention type: OTHER
Intervention: Blood draw
Description: (2) 10 mL tubes will be collected

Intervention type: PROCEDURE
Intervention: Tissue biopsy
Description: Tissue biopsy of metastatic tissue if undergoing clinical care-directed biopsy
Study: NCT03391973

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Pembrolizumab Injection
Description: Pembrolizumab 200 mg will be administered as a 30 minute IV infusion Q3W.
Study: NCT05369910

Intervention type: BEHAVIORAL
Group type: EXPERIMENTAL
Intervention: Light exposure (Flash)
Description: Light exposure (Flash) is administered for one hour on 7 consecutive days. During the light exposure, participants are seated 120 cm in front of a white curtain that is illuminated by an LED light source (Dawe stroboscope type 1214B, 5 Hz).

Intervention type: BEHAVIORAL
Group type: EXPERIMENTAL
Intervention: Light exposure (Flash)
Description: Light exposure (Flash) is administered for one hour on 7 consecutive days. During the light exposure, participants are seated 120 cm in front of a white curtain that is illuminated by an LED light source (Dawe stroboscope type 1214B, 5 Hz).

Intervention type: BEHAVIORAL
Group type: EXPERIMENTAL
Intervention: Light deprivation (Dark)
Description: Light deprivation (Dark) is administered for one hour on 7 consecutive days. During the Dark intervention, participants are seated in a room in complete darkness.
Study: NCT02992808

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: recombinant gonadotropins

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: HP-HMG
Study: NCT00326625

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: 40 mg glatiramer acetate
Description: parenteral drug

Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Placebo
Study: NCT02353182

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Ropivacaine
Description: Administered in caudal/epidural/field block: 0.2% (dose at discretion of anaesthetist)
Study: NCT01417793

Intervention type: BEHAVIORAL
Group type: EXPERIMENTAL
Intervention: Smoking Cessation Program
Description: Comparison of smoking cessation rate among different smoking cessation program
Study: NCT02047474

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

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: leucovorin calcium
Description: Given IV
Study: NCT05369910

Intervention type: BEHAVIORAL
Group type: EXPERIMENTAL
Intervention: Light deprivation (Dark)
Description: Light deprivation (Dark) is administered for one hour on 7 consecutive days. During the Dark intervention, participants are seated in a room in complete darkness.
Study: NCT01276314

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: anti- TNF-a
Description: 25mg BIW, SC

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Prednisolone
Description: 1-1.5 mg / kg / day
Study: NCT03843684

Intervention type: DEVICE
Group type: EXPERIMENTAL
Intervention: 3D-printed foot orthoses
Description: 3D printed foot orthoses with arch support

Intervention type: DEVICE
Group type: EXPERIMENTAL
Intervention: 5 degrees lateral wedge insoles
Description: Insoles with a lateral inclination set at 5 degrees
Study: NCT02677090

Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Placebo (including Maltodextrin)

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Dose 1 - Promitor®

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Dose 2 - Promitor®

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Dose 3 - Promitor®
Study: NCT01860261

Intervention type: BEHAVIORAL
Group type: EXPERIMENTAL
Intervention: Aerobic and Strength Training Intervention
Description: The exercise intervention has three components: (1) aerobic exercise with a metabolic equivalent of task (MET) energy expenditure of at least 900 MET-minutes per week; (2) strength training consisting of 2 sets of 4 upper body exercises (bench press, seated row, shoulder press, and pull down), 3 sets of 3 leg exercises (leg press, extension, and flexion) and 2 sets each of abdominal crunches and back extensions. Weights for each exercise will be gradually increased as participants can complete 12 repetitions for each set on 2 consecutive sessions, with participants performing strength training twice per week total. Three workshops on using ChiWalking or ChiRunning technique for achievement of aerobic activity goals will be provided to participants in the experimental arm.
Study: NCT00514410

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Folic Acid
Description: Folic acid 5 mg once a day for three months as a supplement to their antidepressant treatment

Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Placebo
Description: Matching placebo taken once a day for three months
Study: NCT00240071

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Avastin
Description: All patients will received Avastin 15 mg/kg IV every three weeks. The first evaluation will be done at Week 6. Patients with objective response or stable disease will continue therapy with restaging every 6 weeks until evidence of disease progression. Patients with progression of disease will be taken off study.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Hormonal therapy
Description: aromatase inhibitor (letrozole 2.5mg/d PO, anastrazole 1mg/d PO, or exemestane 25mg/d PO)or Selective Estrogen Receptor Modulator (SERM) (tamoxifen 20mg/d PO)
Study: NCT04261270

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: ASC09F+Oseltamivir
Description: ASC09F tablets:one tablet(400mg/tablet)twice a day for 14 days;Oseltamivir tablet:75mg,once a day

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Ritonavir+Oseltamivir
Description: Ritonavir tablet:three tablets(100mg/tablet)twice a day for 14 days;Oseltamivir tablet:75mg,once a day

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Oseltamivir
Description: 75mg ,once a day
Study: NCT02611258

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Tadalafil
Description: Tadalafil 20 mg to be taken orally once daily, for 3 months
Study: NCT02240381

Intervention type: PROCEDURE
Group type: EXPERIMENTAL
Intervention: assessment of therapy complications
Description: During OGTT 75gm of glucose will be given followed by phlebotomy

Intervention type: PROCEDURE
Group type: EXPERIMENTAL
Intervention: assessment of therapy complications
Description: During clamp procedure tritiated glucose, D20, regular insulin will be given, followed by phlebotomy.

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: laboratory biomarker analysis
Description: Correlative studies
Study: NCT00028756

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: doxorubicin hydrochloride
Description: Given IV

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: doxorubicin hydrochloride
Description: Given IV

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: gemcitabine hydrochloride
Description: Given IV

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: gemcitabine hydrochloride
Description: Given IV

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: vinblastine sulfate
Description: Given IV
Study: NCT01655810

Intervention type: DIETARY_SUPPLEMENT
Group type: ACTIVE_COMPARATOR
Intervention: Vitamin D3
Description: Multivitamin containing cholecalciferol 4000 units orally daily

Intervention type: DIETARY_SUPPLEMENT
Group type: ACTIVE_COMPARATOR
Intervention: Vitamin D3
Description: Multivitamin containing cholecalciferol 600 units orally daily

Intervention type: DIETARY_SUPPLEMENT
Group type: ACTIVE_COMPARATOR
Intervention: Calcium carbonate
Description: 500 mg orally twice daily

Intervention type: DIETARY_SUPPLEMENT
Group type: ACTIVE_COMPARATOR
Intervention: Calcium carbonate
Description: 500 mg orally twice daily
Study: NCT02550509

Intervention type: DEVICE
Group type: EXPERIMENTAL
Intervention: ultrasound echogenicity
Description: ultrasound echogenicity to patient with stroke

Intervention type: DEVICE
Group type: EXPERIMENTAL
Intervention: elastography
Description: elastography to patient with stoke
Study: NCT01826201

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: MOL4239
Description: 10% MOL4239 ointment to one target lesion twice a day for 28.5 consecutive days

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Placebo
Description: placebo ointment to the contralateral target lesion twice a day for 28.5 consecutive days
Study: NCT02290652

Intervention type: OTHER
Intervention: Prospective - Factors affecting sexual function pre-THR
Description: A prospective assessment of factors affecting sexual function in patients whom are awaiting a total hip replacement.~Patients will carry out a prospective 23 question questionnaire: 'Arthroplasty \& Sexual Function Questionnaire (ASFQ) - Pre-operative' with validated questionnaire Female Sexual Function Index (FSFI), before their operation.~Then at 6 months and 12 months post-operatively they will fill out a retrospective 30 question questionnaire: 'Arthroplasty \& Sexual Function Questionnaire (ASFQ) - Post-operative', again with FSFI.

Intervention type: OTHER
Intervention: Retrospective- Factors affecting sexual function post-THR
Description: A retrospective assessment of factors affecting sexual function in patients whom have undergone a total hip replacement (THR) in the preceding year.~Patients will carry out a retrospective 30 question questionnaire: 'Arthroplasty \& Sexual Function Questionnaire (ASFQ) - Post-operative' with validated questionnaire Female Sexual Function Index (FSFI), at 6 months and/or 12 months (wherever possible).~Maximum retrospective collection of data 12 months.
Study: NCT00442572

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: PEGASYS [peginterferon alfa-2a]
Description: There were 4 treatment cycles of continuous intermittent treatment with Peginterferon alfa-2a. Each cycle consisted of 12 weeks injection treatment with Peginterferon alfa-2a 135 micrograms in 0.5 ml solution in prefilled syringes, applied once weekly subcutaneously and followed by 12 weeks period without treatment.