TrialPanorama/TrialPanorama-database huggingface dataset:
Study: NCT00724620

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: Peginterferon alfa-2b (SCH 054031)
Description: All patients will receive peginterferon alfa-2b 1.5 ug/kg administered subcutaneously (SC) once weekly in combination with ribavirin (800-1200 mg/day) administered orally (PO) for a minimum period of 12 weeks. The total treatment duration will be as follows: 48 weeks for Early Responders, 72 weeks for Slow Responders, and 12 weeks for Nonresponders.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Ribavirin (SCH 018908)
Description: All patients will receive peginterferon alfa-2b 1.5 ug/kg administered subcutaneously (SC) once weekly in combination with ribavirin (800-1200 mg/day) administered orally (PO) for a minimum period of 12 weeks. The total treatment duration will be as follows: 48 weeks for Early Responders, 72 weeks for Slow Responders, and 12 weeks for Nonresponders.
Study: NCT00900250

Intervention type: OTHER
Intervention: Cytology Specimen Collection Procedure
Description: Correlative studies
Study: NCT03578848

Intervention type: DEVICE
Group type: ACTIVE_COMPARATOR
Intervention: uAOBP
Description: For the uAOBP and CBP, the measurements will be conducted in a quiet room without the presence of clinical personnel. Patients will be seated in a quiet room without talking and taken as an average of 3 measurements with an automated device (HEM-907, Omron Healthcare, Lake Forest, IL) that has been preset to wait 5 minutes before measurements. Simultaneously, the central BP will be measured in the other upper arm. (WatchBP Office Central; Microlife AG, Widnau, Switzerland). The determination of the right or left upper arm for uAOBP or central BP will be made in a random order by computer generated random codes before the enrollment.
Study: NCT00724620

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Ribavirin (SCH 018908)
Description: All patients will receive peginterferon alfa-2b 1.5 ug/kg administered subcutaneously (SC) once weekly in combination with ribavirin (800-1200 mg/day) administered orally (PO) for a minimum period of 12 weeks. The total treatment duration will be as follows: 48 weeks for Early Responders, 72 weeks for Slow Responders, and 12 weeks for Nonresponders.
Study: NCT00956306

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Udenafil
Description: 100mg Single Oral Dose of Udenafil

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Udenafil
Description: 100mg Single Oral Dose of Udenafil

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Udenafil
Description: 100mg Single Oral Dose of Udenafil
Study: NCT02862249

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: Faecal microbiota transplantation
Description: The FMT (200mls) will be administered following preparation of the bowel with MoviPrep®, into the duodenum via a gastroscope derived from 50g of fresh donated stool from a healthy donor. The gastroscopy will be performed as per the King's College Hospital Gastroenterology Protocol.

Intervention type: BIOLOGICAL
Group type: PLACEBO_COMPARATOR
Intervention: Placebo
Description: An identical appearing placebo solution (200mls 0.9% normal saline and 12.5% glycerol) will be administered into the duodenum via a gastroscope in a single blinded fashion following preparation of the bowel with MoviPrep®.
Study: NCT02506218

Intervention type: DIETARY_SUPPLEMENT
Group type: EXPERIMENTAL
Intervention: 10 + 20 g protein consumption
Description: whey isolate

Intervention type: OTHER
Group type: ACTIVE_COMPARATOR
Intervention: 30 g protein breakfast
Description: 30 g mixed meal breakfast

Intervention type: OTHER
Group type: ACTIVE_COMPARATOR
Intervention: 10 g protein breakfast
Description: 10 g mixed meal breakfast
Study: NCT03578848

Intervention type: DEVICE
Group type: EXPERIMENTAL
Intervention: Home BP
Description: As for the home BP measurements, a validated device (WatchBP Home; Microlife AG, Widnau, Switzerland) will be provided for all subjects allocated to the home BP arm to measure their BP at home. Subjects are requested to take BP in the morning (within 2 hours after awakening) and afternoon before meals for 7 consecutive days before the scheduled clinical visits. BP in the first day of the measurements will be discarded and an average of home BP (all BP reading and BP in the morning and in the afternoon) will be generated and provided for clinicians to guide their treatment.
Study: NCT04679142

Intervention type: DRUG
Intervention: Baclofen Tablets
Description: Enrolled patients will receive treatment and evaluations for their disease as determined by their physicians in accordance with local standard of care. Visits will be scheduled by their physician according to patient-specific needs and national clinical practice.
Study: NCT02541084

Intervention type: DRUG
Intervention: Aflibercept (Eylea, VEGF Trap-Eye, BAY86-5321)
Description: Anti-VEGF therapy following the Summary of Product Characteristics

Intervention type: DRUG
Intervention: Aflibercept (Eylea, VEGF Trap-Eye, BAY86-5321)
Description: Anti-VEGF therapy following the Summary of Product Characteristics
Study: NCT03312335

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Low-dose Aldesleukin (Proleukin®)
Description: Subcutaneous injection of 1.5 million international units (MIU) of Aldesleukin (Proleukin®, Interleukin-2) once daily in 5-day courses every three weeks for a total of 4 cycles.
Study: NCT02541084

Intervention type: DRUG
Intervention: Aflibercept (Eylea, VEGF Trap-Eye, BAY86-5321)
Description: Anti-VEGF therapy following the Summary of Product Characteristics
Study: NCT02371421

Intervention type: DRUG
Intervention: Allopurinol
Study: NCT03321526

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: JNJ-42847922
Description: Participants will receive JNJ-42847922 capsule orally.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Placebo Matching to JNJ-42847922
Description: Participants will receive placebo capsule matching to JNJ-42847922 orally.

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Quetiapine XR
Description: Participants will receive quetiapine XR capsule orally.

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Placebo Matching to Quetiapine XR
Description: Participants will receive placebo capsule matching to quetiapine XR orally.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Selective Serotonin Reuptake Inhibitor (SSRI)
Description: Participants will receive SSRI antidepressant (such as, citalopram, escitalopram, fluvoxamine, fluoxetine, paroxetine, sertraline, vilazodone or vortioxetine) as a part of background therapy (at the same dose, without change, every day and at approximately the same time as prior to entering the study) throughout the screening, double-blind, and follow-up phases (approximately up to Week 26).

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Selective Serotonin Reuptake Inhibitor (SSRI)
Description: Participants will receive SSRI antidepressant (such as, citalopram, escitalopram, fluvoxamine, fluoxetine, paroxetine, sertraline, vilazodone or vortioxetine) as a part of background therapy (at the same dose, without change, every day and at approximately the same time as prior to entering the study) throughout the screening, double-blind, and follow-up phases (approximately up to Week 26).

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Serotonin-Norepinephrine Reuptake Inhibitor (SNRI)
Description: Participants will receive SNRI antidepressant (such as duloxetine, milnacipran, levomilnacipran, venlafaxine, desvenlafaxine) as a part of background therapy (at the same dose, without change, every day and at approximately the same time as prior to entering the study) throughout the screening, double-blind, and follow-up phases (approximately up to Week 26).

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Serotonin-Norepinephrine Reuptake Inhibitor (SNRI)
Description: Participants will receive SNRI antidepressant (such as duloxetine, milnacipran, levomilnacipran, venlafaxine, desvenlafaxine) as a part of background therapy (at the same dose, without change, every day and at approximately the same time as prior to entering the study) throughout the screening, double-blind, and follow-up phases (approximately up to Week 26).
Study: NCT03115606

Intervention type: DEVICE
Group type: ACTIVE_COMPARATOR
Intervention: C-Mac D Blade
Description: Videolaryngoscope

Intervention type: DEVICE
Group type: ACTIVE_COMPARATOR
Intervention: Fastrach LMA
Description: Laryngeal mask airway
Study: NCT01687452

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: Blood samples

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: Blood samples

Intervention type: BIOLOGICAL
Group type: PLACEBO_COMPARATOR
Intervention: Blood samples
Study: NCT00612586

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Enzastaurin
Description: 1125 milligram (mg) loading dose, then 250 mg twice daily, oral up to 1 year (yr) or until progressive disease

Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Placebo
Description: oral, daily (up to 1 yr or until progressive disease)

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Leucovorin (LV)
Description: 400 milligram per meter squared (mg/m\^2) intravenously (IV), Day 1 of 14 day cycle (up to 1 yr or until progressive disease)

Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Leucovorin (LV)
Description: 400 milligram per meter squared (mg/m\^2) intravenously (IV), Day 1 of 14 day cycle (up to 1 yr or until progressive disease)

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: 5-fluorouracil (5-FU)
Description: 400 mg/m\^2 bolus then 2400 mg/m\^2 IV over 46 hours, Day 1 of 14 day cycle (up to 1 yr or until progressive disease)

Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: 5-fluorouracil (5-FU)
Description: 400 mg/m\^2 bolus then 2400 mg/m\^2 IV over 46 hours, Day 1 of 14 day cycle (up to 1 yr or until progressive disease)

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Bevacizumab (Bev)
Description: 5 milligram per kilogram (mg/kg) IV, Day 1 of 14 day cycle (up to 1 yr or until progressive disease)

Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Bevacizumab (Bev)
Description: 5 milligram per kilogram (mg/kg) IV, Day 1 of 14 day cycle (up to 1 yr or until progressive disease)
Study: NCT03922867

Intervention type: BEHAVIORAL
Group type: ACTIVE_COMPARATOR
Intervention: CBT
Description: A web-based educational platform to deliver cognitive behavioral therapy (CBT) for insomnia
Study: NCT02613364

Intervention type: BEHAVIORAL
Group type: EXPERIMENTAL
Intervention: Behavioral Intervention
Description: Undergo yoga intervention

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: Cognitive Intervention
Description: Undergo CBT-I intervention

Intervention type: OTHER
Group type: ACTIVE_COMPARATOR
Intervention: Educational Intervention
Description: Receive health education

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: Laboratory Biomarker Analysis
Description: Correlative studies

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: Laboratory Biomarker Analysis
Description: Correlative studies

Intervention type: OTHER
Group type: ACTIVE_COMPARATOR
Intervention: Laboratory Biomarker Analysis
Description: Correlative studies

Intervention type: DEVICE
Group type: EXPERIMENTAL
Intervention: Monitoring Device
Description: Correlative studies

Intervention type: DEVICE
Group type: EXPERIMENTAL
Intervention: Monitoring Device
Description: Correlative studies

Intervention type: DEVICE
Group type: ACTIVE_COMPARATOR
Intervention: Monitoring Device
Description: Correlative studies

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

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

Intervention type: OTHER
Group type: ACTIVE_COMPARATOR
Intervention: Quality-of-Life Assessment
Description: Ancillary studies
Study: NCT03557658

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Bexagliflozin
Description: Single oral dose of bexagliflozin tablet, 20 mg

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Bexagliflozin
Description: Single oral dose of bexagliflozin tablet, 20 mg
Study: NCT01667354

Intervention type: BEHAVIORAL
Group type: EXPERIMENTAL
Intervention: Academic Detailing
Description: The intervention design is based on academic detailing, an effective method of changing physician behavior. The aim of the training is effective communication with parents who are hesitant about childhood vaccinations.
Study: NCT04946045

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: Sensorimotor Interventions (Tactile/Kinesthetic Stimulation+Nonnutritive Sucking)
Description: Sensorimotor interventions were applied to in preterm infants between 30-33 weeks of age for 10 days. After that, preterms were included in the Six-phase feeding progression protocol.
Study: NCT03330314

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: HM12460A
Description: HM12460A is a long-acting insulin

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: HM12460A
Description: HM12460A is a long-acting insulin

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: HM12460A
Description: HM12460A is a long-acting insulin

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: HM12460A
Description: HM12460A is a long-acting insulin
Study: NCT04201470

Intervention type: OTHER
Group type: ACTIVE_COMPARATOR
Intervention: Blood withdrawal
Description: Measurement of serum neurofilaments light chain and GFAP

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: Blood withdrawal
Description: Measurement of serum neurofilaments light chain and GFAP

Intervention type: OTHER
Group type: ACTIVE_COMPARATOR
Intervention: MRI
Description: Cervical and cerebral MRI without contrast injection

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: MRI
Description: Cervical and cerebral MRI without contrast injection

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: Neurologic / neuropsychologic tests - Patients
Description: EDSS (Expanded Disability Status Scale), NHPT (Nine Hole Peg Test), T25FW (Timed 25-Foot Walk Test), 6MWT (Six-Minute Walk Test), CSCT (Computerized version of the Symbol Digit Modalities Test)

Intervention type: OTHER
Group type: ACTIVE_COMPARATOR
Intervention: Neurologic / neuropsychologic tests - Controls
Description: NHPT, T25FW, CSCT
Study: NCT00467831

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Losartan
Description: Losartan potassium tablet, 25 mg by mouth every night at bedtime.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Zileuton
Description: Zileuton tablet, 1200 mg by mouth twice daily.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: N-Acetylcysteine
Description: N-acetylcysteine solution, 600 mg by mouth three times daily.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Pravastatin
Description: Pravastatin sodium tablet, 20 mg by mouth every night at bedtime.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Erythromycin
Description: Erythromycin tablet, 333 mg by mouth three times daily.
Study: NCT02860819

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Veliparib
Description: Veliparib 250mg BID, continuously

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Gemcitabine
Description: Gemcitabine 800mg/m2, day 1 and 8

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Carboplatin
Description: Carboplatin AUC = 4, day 1
Study: NCT00928226

Intervention type: RADIATION
Group type: EXPERIMENTAL
Intervention: Fractionated Stereotactic Radiosurgery (SRS)
Description: Standard of care
Study: NCT03578848

Intervention type: DEVICE
Group type: ACTIVE_COMPARATOR
Intervention: Home BP
Description: As for the home BP measurements, a validated device (WatchBP Home; Microlife AG, Widnau, Switzerland) will be provided for all subjects allocated to the home BP arm to measure their BP at home. Subjects are requested to take BP in the morning (within 2 hours after awakening) and afternoon before meals for 7 consecutive days before the scheduled clinical visits. BP in the first day of the measurements will be discarded and an average of home BP (all BP reading and BP in the morning and in the afternoon) will be generated and provided for clinicians to guide their treatment.

Intervention type: DEVICE
Group type: EXPERIMENTAL
Intervention: CBP
Description: For the uAOBP and CBP, the measurements will be conducted in a quiet room without the presence of clinical personnel. Patients will be seated in a quiet room without talking and taken as an average of 3 measurements with an automated device (HEM-907, Omron Healthcare, Lake Forest, IL) that has been preset to wait 5 minutes before measurements. Simultaneously, the central BP will be measured in the other upper arm. (WatchBP Office Central; Microlife AG, Widnau, Switzerland). The determination of the right or left upper arm for uAOBP or central BP will be made in a random order by computer generated random codes before the enrollment.
Study: NCT04070768

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Gemtuzumab Ozogamicin
Description: Gemtuzumab Ozogamicin 3mg/m\^2, Days 1,4,7

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Venetoclax
Description: Venetoclax, 100,200,400, or 600mg Daily Dose
Study: NCT02976376

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: The Box
Description: The Box contains four smartphone compatible devices. Patients will measure their vital signs and automatically send them to the hospital.
Study: NCT04279379

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Sintilimab
Description: 200mg d1,ivdrip, repeated every 3 weeks

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Decitabine
Description: 10mg d1-5, ivdrip,repeated every 3 weeks
Study: NCT01218412

Intervention type: BEHAVIORAL
Group type: EXPERIMENTAL
Intervention: Web-based Motivational Interviewing
Description: Participants will engage in 4 sessions of web-based motivational interviewing over the course of 4 weeks.
Study: NCT01117688

Intervention type: PROCEDURE
Group type: ACTIVE_COMPARATOR
Intervention: Ureteroscopy with and without safety guidewire
Description: In study arm A - with SGW, endoscopic treatment is performed with a safety guidewire in place. In study arm B - without SGW, the ureteroscopy is performed without SGW.

Intervention type: PROCEDURE
Group type: ACTIVE_COMPARATOR
Intervention: Ureteroscopy with and without safety guidewire
Description: In study arm A - with SGW, endoscopic treatment is performed with a safety guidewire in place. In study arm B - without SGW, the ureteroscopy is performed without SGW.
Study: NCT00958308

Intervention type: OTHER
Group type: ACTIVE_COMPARATOR
Intervention: BIO-K+ CL-1285®
Description: A mixture of Lactobacillus acidophilus and Lactobacillus casei, contains over 50 billion living bacteria per administered dose.

Intervention type: OTHER
Group type: OTHER
Intervention: BIO-K+ CL-1285®
Description: A mixture of Lactobacillus acidophilus and Lactobacillus casei, contains over 50 billion living bacteria per administered dose.
Study: NCT01992354

Intervention type: DEVICE
Group type: EXPERIMENTAL
Intervention: PET MR Device
Description: GE PET/MRI system
Study: NCT00958308

Intervention type: OTHER
Group type: OTHER
Intervention: Placebo
Description: Placebo is devoid of microorganisms.

Intervention type: OTHER
Group type: PLACEBO_COMPARATOR
Intervention: Placebo
Description: Placebo is devoid of microorganisms.
Study: NCT01762657

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Oral Cyclosporine and Oral Lansoprazole
Description: Oral Cyclosporine A dosed at 7.5 mg/kg/day and Oral Lansoprazole dosed at 30 mg in two divided dosages to subjects ages 8-15 and 60 60 mg in divided dosages to subjects ages 16-60. The Cyclosporine A and Lansoprazole may be given as an oral tablet/capsule or oral suspension.

Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Placebos
Description: Two oral placebos are given at breakfast and dinner. The placebos may be given as an oral tablets/capsules or oral suspensions.
Study: NCT05374616

Intervention type: GENETIC
Intervention: Observation
Description: Retrospective and prospective Natural History Study
Study: NCT04269954

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Batroxobin combined with low molecular weight heparin
Description: Standard treatment of Batroxobin combined with low molecular weight heparin

Intervention type: DRUG
Group type: OTHER
Intervention: Batroxobin combined with low molecular weight heparin
Description: Standard treatment of Batroxobin combined with low molecular weight heparin
Study: NCT04806152

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: High intensity exercise
Description: Supervised high-intensity combined-modality exercise was administered to participants in the exercise arm for 3 times per week for 6 months. A post-exercise recovery protein drink (31g whey-based) was given within 15 minutes after each supervised exercise session.

Intervention type: OTHER
Group type: ACTIVE_COMPARATOR
Intervention: Usual care home exercise
Description: Walking 30 minutes, chair rises and flexibility exercises for trunk and upper extremities 5 days per week
Study: NCT02347410

Intervention type: DEVICE
Group type: OTHER
Intervention: SIFS graft containment device
Description: The SIFS mesh is a graft containment and reinforcement device. Following conventional thorough discectomy, the disc space is entered through a small portal in the annulus, the SIFS mesh is introduced, deployed and then filled with bone graft. Bilateral commercially available posterior lumbar fixation is applied.
Study: NCT02525198

Intervention type: DIETARY_SUPPLEMENT
Group type: EXPERIMENTAL
Intervention: fatty acid/flavonoid blend
Description: see arm description

Intervention type: DIETARY_SUPPLEMENT
Group type: PLACEBO_COMPARATOR
Intervention: Placebo
Description: see arm description
Study: NCT00702052

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Everolimus
Description: Everolimus tablets
Study: NCT03003780

Intervention type: BEHAVIORAL
Group type: EXPERIMENTAL
Intervention: Mindful Steps
Description: Integrated website, activity tracker, and mind-body training
Study: NCT02808533

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Topiramate
Description: Topiramate capsules starting with 25 mg b.i.d with an incremental increase of 25 mg b.i.d weekly upto a maximum of 100 mg b.i.d.

Intervention type: OTHER
Group type: PLACEBO_COMPARATOR
Intervention: Placebo
Description: Placebo capsules visually identical to those containing topiramate will be administered.
Study: NCT00928226

Intervention type: RADIATION
Group type: EXPERIMENTAL
Intervention: Fractionated Stereotactic Radiosurgery (SRS)
Description: Standard of care

Intervention type: RADIATION
Group type: EXPERIMENTAL
Intervention: Fractionated Stereotactic Radiosurgery (SRS)
Description: Standard of care
Study: NCT01266655

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Baclofen
Description: Baclofen will be administered orally for a maximum of 20 consecutive weeks. For the first 3 days, patients will receive baclofen in a dose of 5 milligrams t.i.d.; subsequently, the daily dose of baclofen will be increased to a maximum of 90 milligrams t.i.d. within 4 weeks. In case of intolerance, dosage can be decreased to a minimum of 10 mg t.i.d.. Patients will receive maximum tolerated dosage of baclofen for 12 weeks. Medication will then gradually be tapered over a maximum of 4 weeks.