TrialPanorama/TrialPanorama-database huggingface dataset:
Study: NCT00514020

Intervention type: GENETIC
Group type: EXPERIMENTAL
Intervention: gene expression analysis
Description: Blood collection

Intervention type: GENETIC
Group type: EXPERIMENTAL
Intervention: polymorphism analysis
Description: Blood collection

Intervention type: GENETIC
Group type: EXPERIMENTAL
Intervention: protein expression analysis
Description: Blood collection

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: pharmacological study
Description: Blood collection
Study: NCT02032342

Intervention type: DEVICE
Group type: PLACEBO_COMPARATOR
Intervention: Endobronchial double lumen tube
Description: Endobronchial double lumen tube for one lug ventilation

Intervention type: DEVICE
Group type: ACTIVE_COMPARATOR
Intervention: Arndt® blocker
Description: Arndt® blocker for selective lobar deflation

Intervention type: DEVICE
Group type: ACTIVE_COMPARATOR
Intervention: Cohen blocker
Description: Cohen blocker for selective lobar deflation

Intervention type: DEVICE
Group type: ACTIVE_COMPARATOR
Intervention: Fuji Uni-blocker
Description: Fuji Uni-blocker foe selective lobar deflation
Study: NCT00002670

Intervention type: RADIATION
Group type: EXPERIMENTAL
Intervention: low-LET electron therapy

Intervention type: RADIATION
Group type: ACTIVE_COMPARATOR
Intervention: low-LET photon therapy

Intervention type: RADIATION
Group type: EXPERIMENTAL
Intervention: low-LET photon therapy
Study: NCT03558399

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: FET according to ERA
Description: Single euploid FET will be performed at the time indicated by the ERA test results.

Intervention type: OTHER
Group type: ACTIVE_COMPARATOR
Intervention: FET according to standard protocol
Description: Single euploid FET will be performed according to our standard FET protocol.
Study: NCT01055678

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: EF5
Description: An infusion of EF5, a fluorinated 2-nitroimidazole, will be administered using the recommended dose of 21mg/kg one day prior to surgical procedure.

Intervention type: PROCEDURE
Group type: EXPERIMENTAL
Intervention: Partial or Total Mastectomy
Description: A small tissue sample will be removed from the excised tissue and will be stored for later analysis.
Study: NCT00429507

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: 153 Sm-EDTMP
Description: Tracer dose = 30 mCi by vein On Day 1. If enough study drug goes to bones, will receive a higher dose of 153 Sm-EDTMP, called a therapy dose, 7-14 days after the tracer dose.

Intervention type: BEHAVIORAL
Group type: EXPERIMENTAL
Intervention: Questionnaire
Description: Questionnaires taking about 15 minutes to complete.

Intervention type: PROCEDURE
Group type: EXPERIMENTAL
Intervention: Stem Cell Transplant
Description: Stem Cell Transplant on Day 0, about 14-21 days after Samarium 153-EDTMP.
Study: NCT03257553

Intervention type: DIAGNOSTIC_TEST
Group type: EXPERIMENTAL
Intervention: fecal calprotectin , doppler and ultrasound
Description: faecal sample for measurement of calprotectin level ultrasound and doppler
Study: NCT00064402

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: arformoterol tartrate inhalation solution
Description: arformoterol 50 mcg QD
Study: NCT02493699

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: physical exercise- based intervention (Karate techniques training)
Study: NCT00672789

Intervention type: BEHAVIORAL
Group type: EXPERIMENTAL
Intervention: Blood smear education
Description: education at baseline and three month follow-up

Intervention type: OTHER
Group type: ACTIVE_COMPARATOR
Intervention: standard education
Description: standard education
Study: NCT04416503

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: Foot reflexology
Description: Foot reflexology was performed for 12 week in the study group,whereas the control group continued their routine treatment and follow-up.
Study: NCT04900831

Intervention type: DIAGNOSTIC_TEST
Intervention: Omnipolar Eletroanatomical mapping
Description: Analyse intracardiac EGMs collected with the HD Grid catheter (Abbott, Chicago, IL) during routine Atrial Flutter ablation using the Omnipolar algorithm.
Study: NCT03787251

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Apatinib
Description: It is recommended that the initial dose of apatinib is 500mg po qd. Adjust the dose to 750mg po qd or maintain the original dose according to the patient's medication response for about 2 weeks. If there is grade III or above, or grade II and above non-hematologic toxicity, allow the dose to be lowered 2 times.

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: The chemotherapeutic drug chosen by the investigator.
Description: The choice of chemotherapy regimen is based on the medication habits of the drug delivery doctor and the specific circumstances of the patient.~In addition, the following regimens may be selected as monotherapy or combination: docetaxel 60-75 mg/m2d1 q3w; irinotecan 150-180 mg/m2 d1 q2w until disease progression or patient death. If grade 3 and above or non-hematologic toxicity of grade II and above adverse event appeared, allowing the dose to be lowered twice.
Study: NCT01648907

Intervention type: OTHER
Intervention: Imaging exams
Description: Radiological examinations:~* Standard x-ray: they include an x-ray of the cervical, thoracic, and lumbar spine (side-on), of the lumbar spine from the front and an x-ray of the pelvis from the front~* MRI scan: are taken of the cervical, thoracic and lumbar spine and sacroiliac joints.~Bone densitometry: evaluation of bone densitometry of the lumbar spine and femoral neck.~Enthesis ultrasound: bilateral evaluation of entheseal insertions for the Achilles tendon, patella tendons and epicondyle tendons.~Biological tests :~* Genetic test : DNA will be collected at the first visit from all centers. RNA will be collected at the inclusion visit in AP-HP centres only.~* Serum will be collected by all centres at the initial visit, then in M6, M12 and M24 for the first two years of the study, then in M60.~* Urine will be collected by all centres at the initial visit, then in M24 for the first two years of the study, then in M60.
Study: NCT01287897

Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: PF-04236921 SC injection
Description: Placebo delivered SC, 2 doses separated by 4 weeks

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: PF-04236921 SC injection
Description: Drug dose level 1 delivered SC, 2 doses separated by 4 weeks

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: PF-04236921 SC injection
Description: Drug dose level 2 delivered SC, 2 doses separated by 4 weeks
Study: NCT00759863

Intervention type: BEHAVIORAL
Group type: EXPERIMENTAL
Intervention: Lifezig
Description: Personalized Reminiscence Video
Study: NCT00064402

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: arformoterol tartrate inhalation solution
Description: arformoterol 25 mcg BID
Study: NCT02143440

Intervention type: BEHAVIORAL
Group type: OTHER
Intervention: The initial assessment of daily insulin dose.
Study: NCT02637700

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Intravenous Immunoglobulin
Description: Comparison between intravenous immunoglobulin and placebo (saline 0.9%).

Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Placebo
Description: Comparison between placebo (saline 0.9%) and intravenous immunoglobulin.
Study: NCT00064402

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: arformoterol tartrate inhalation solution
Description: arformoterol 15 mcg BID
Study: NCT03877289

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Oxybutynin
Description: Oxybutynin is a tertiary amine anticholinergic. It exerts both antispasmodic and antimuscarinic activity on smooth muscle. It also exerts analgesic and local anaesthetic effects.

Intervention type: OTHER
Group type: PLACEBO_COMPARATOR
Intervention: Orasweet Liquid Placebo
Description: A formulated Oxybutynin placebo that is nearly identical in appearance, volume, weight, taste, and smell.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Antibiotics
Description: All patients in treatment and control arms were treated as a co-intervention with an oral antibioitic, the type of which was chosen by the child's attending physician.~Possible prescribed antibiotics include: trimethoprim and sulfamethoxazole (Septra), Cefalotin, Cephalexin, Cefapirin, Cefdroxil, Cefazolin, Cefradine, Cefacetrile, Cefaloridine, Cefroxadine, Cefatrizine, Cefuroxime, Cefixime, amoxicillin/clavulanic acid (Clavulin), and Nitrofurantoin.

Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Antibiotics
Description: All patients in treatment and control arms were treated as a co-intervention with an oral antibioitic, the type of which was chosen by the child's attending physician.~Possible prescribed antibiotics include: trimethoprim and sulfamethoxazole (Septra), Cefalotin, Cephalexin, Cefapirin, Cefdroxil, Cefazolin, Cefradine, Cefacetrile, Cefaloridine, Cefroxadine, Cefatrizine, Cefuroxime, Cefixime, amoxicillin/clavulanic acid (Clavulin), and Nitrofurantoin.
Study: NCT02002364

Intervention type: PROCEDURE
Group type: ACTIVE_COMPARATOR
Intervention: tracheal intubation

Intervention type: PROCEDURE
Group type: ACTIVE_COMPARATOR
Intervention: tracheal intubation
Study: NCT01021748

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: MK-2206
Description: Oral tablets

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: MK-2206
Description: Oral tablets

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: MK-2206
Description: Oral tablets

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: MK-2206
Description: Oral tablets

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: AZD6244
Description: Oral capsules

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: AZD6244
Description: Oral capsules

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: AZD6244
Description: Oral capsules

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: AZD6244
Description: Oral capsules

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: AZD6244
Description: Oral capsules

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: AZD6244
Description: Oral capsules

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: AZD6244
Description: Oral capsules

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: AZD6244
Description: Oral capsules

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: AZD6244
Description: Oral capsules
Study: NCT02743039

Intervention type: BEHAVIORAL
Group type: EXPERIMENTAL
Intervention: CareerAdvance®
Description: CareerAdvance® is a dual-generation program providing education, career coaching, and soft-skills training for parents while their children attend CAP Tulsa's Head Start programs.
Study: NCT01229332

Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Saline
Description: Continuous 24 h administration

Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Carbidopa
Description: Continuous 24 h administration
Study: NCT01890954

Intervention type: DEVICE
Group type: ACTIVE_COMPARATOR
Intervention: Diabetes Assistant (DiAs)
Description: Diabetes Assistance (DiAs) is a software residing in a Smartphone that contains the algorithms to regulate and control insulin deliveries (insulin bolus for: Basal rate, meal insulin and correction bolus) with inputs glucose values from a CGM and outputs insulin infusion by an insulin pump
Study: NCT04482556

Intervention type: DEVICE
Group type: OTHER
Intervention: Q-NRG+ Indirect Calorimetry Device
Description: The two indirect calorimetry devices will be tested in an alternating fashion for each enrolled patient. Each enrolled patient subsequently will alternate in which device is tested first.

Intervention type: DEVICE
Group type: OTHER
Intervention: V(max) Encore Indirect Calorimetry Device
Description: The two indirect calorimetry devices will be tested in an alternating fashion for each enrolled patient. Each enrolled patient subsequently will alternate in which device is tested first.
Study: NCT02294994

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: tirofiban
Study: NCT04648800

Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: 0.9% saline
Description: 0.9% saline
Study: NCT02411916

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: misoprostol
Description: rectal insertion
Study: NCT02294994

Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: tirofiban

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: tirofiban
Study: NCT01271894

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Efavirenz
Description: 600 mg once daily; given as 3 x 200 mg once

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Efavirenz
Description: 400 mg once daily; given as 2 x 200 mg + 1 x placebo
Study: NCT00578344

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Busulfan
Description: Starting Day -9 / Busulfan 4.0 mg/kg/day IV divided into four doses daily for four days; total dose = 16 mg/kg.

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: Campath 1H
Description: Day -5 through Day -2; Campath-1H dosed as per institutional guidelines.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Cyclophosphamide and MESNA
Description: Day -5 through Day -2; Cyclophosphamide 50 mg/kg + MESNA.
Study: NCT01836523

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: liraglutide
Description: Subjects randomised to 0.6 mg liraglutide treatment or liraglutide placebo as an add-on to their pre-trial insulin treatment will remain on this dose throughout the study (52 weeks). Administered subcutaneously (s.c., under the skin) once daily.

Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: placebo
Description: Subjects randomised to 0.6 mg liraglutide treatment or liraglutide placebo as an add-on to their pre-trial insulin treatment will remain on this dose throughout the study (52 weeks). Administered subcutaneously (s.c., under the skin) once daily.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: liraglutide
Description: Subjects randomised to 0.6 mg liraglutide treatment or liraglutide placebo as an add-on to their pre-trial insulin treatment will remain on this dose throughout the study (52 weeks). Administered subcutaneously (s.c., under the skin) once daily.

Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: placebo
Description: Subjects randomised to 0.6 mg liraglutide treatment or liraglutide placebo as an add-on to their pre-trial insulin treatment will remain on this dose throughout the study (52 weeks). Administered subcutaneously (s.c., under the skin) once daily.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: liraglutide
Description: Subjects randomised to 0.6 mg liraglutide treatment or liraglutide placebo as an add-on to their pre-trial insulin treatment will remain on this dose throughout the study (52 weeks). Administered subcutaneously (s.c., under the skin) once daily.

Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: placebo
Description: Subjects randomised to 0.6 mg liraglutide treatment or liraglutide placebo as an add-on to their pre-trial insulin treatment will remain on this dose throughout the study (52 weeks). Administered subcutaneously (s.c., under the skin) once daily.
Study: NCT04159545

Intervention type: OTHER
Intervention: Qualitative and quantitative interviews
Description: Qualitative semi-structured interviews and quantitative questionnaires

Intervention type: OTHER
Intervention: Qualitative and quantitative interviews
Description: Qualitative semi-structured interviews and quantitative questionnaires
Study: NCT05359666

Intervention type: DEVICE
Group type: EXPERIMENTAL
Intervention: Irrisept
Description: Irrisept® is a manual, self-contained irrigation device designed for wound cleansing and irrigation. The solution is 0.05% Chlorhexidine Gluconate (CHG) in sterile water for irrigation, USP (99.95%). Irrisept contents include the solution, a 450 mL bottle, and the Irriprobe applicator. Irrisept is a manual, self-contained irrigation device that can produce 7-8 psi of pressure for effective wound cleansing and irrigation. The user squeezes the bottle to create streams of solution and directs the fluid from the applicator onto a wound. The mechanical action of the streams of fluid being applied over a wound removes particulates and debris.~Subjects randomized to Irrisept on study protocol IRR-CT-901-2013-01 used the device, per the provided Instructions for Use. Those randomized to SoC received routine care, per the discretion of the investigator, and in accordance with the institution's guidelines.

Intervention type: DEVICE
Group type: ACTIVE_COMPARATOR
Intervention: Standard of Care
Description: Subjects randomized to SoC on study protocol IRR-CT-901-2013-01 used any SoC type, per the investigator's discretion. SoC types were not standardized. Sites recorded SoC information as free text. The following were recorded as SoC types: Saline (recorded as normal, warm and/or sterile saline or saline solution); Sodium Chloride (recorded as sodium chloride (NACL) or NACL 0.9%); SoC; Irrisept (recorded as normal saline \& Irrisept and Irrisept); Chloraprep; Gentamicin \& saline; unknown; and none.
Study: NCT03020407

Intervention type: PROCEDURE
Group type: EXPERIMENTAL
Intervention: IVC Ultrasound-guided
Description: IVC is identified in longitudinal section in the subcostal area of a patient using the curvilinear probe of standard ultrasound. The selected area of IVC diameter measurement is set at 2 centimeters distal to the confluence of hepatic vein by M-mode coupled by two-dimensional mode on frozen screen images using the Sonosite® X-porte.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Antibiotics
Description: Prompt empirical antibiotics will be given to the patients within one hour before the treatment allocation.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Vasopressor
Description: The threshold to the need of a vasopressor is set at mean arterial pressure below 65 mmHg if a patient's condition does not response to the fluid therapy.
Study: NCT00064402

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Salmeterol
Description: Salmeterol MDI 42 mcg BID

Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Placebo
Description: Placebo BID
Study: NCT02297165

Intervention type: BEHAVIORAL
Group type: EXPERIMENTAL
Intervention: olfactory stimulation program
Description: 8 individual sessions of olfactory stimulation at the rate of 2 sessions per week. 3 semi-directed interviews will be help (one at the beginning of the trial, the second 5 weeks later and the third at 6 month).~For each session, patients have to smell two different odors (previously selected from a panel presented to the patient during first visits) and then they are invited to evoke memories and feelings related to each odor.
Study: NCT03481153

Intervention type: DEVICE
Group type: PLACEBO_COMPARATOR
Intervention: Transcranial direct current stimulation (tDCS)
Description: tDCS is a safe, non-invasive neurostimulation technique that can modulate neural excitability in the brain to positively impact cognition, behaviour and mood, particularly when combined with a behavioural intervention

Intervention type: DEVICE
Group type: ACTIVE_COMPARATOR
Intervention: Transcranial direct current stimulation (tDCS)
Description: tDCS is a safe, non-invasive neurostimulation technique that can modulate neural excitability in the brain to positively impact cognition, behaviour and mood, particularly when combined with a behavioural intervention
Study: NCT03180476

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Apatinib
Description: Apatinib, also known as YN968D1, is a tyrosine kinase inhibitor that selectively inhibits the vascular endothelial growth factor receptor-2 (VEGFR2, also known as KDR). It is an orally bioavailable, small molecule agent which is thought to inhibit angiogenesis in cancer cells; specifically apatinib inhibits VEGF-mediated endothelial cell migration and proliferation thus blocking new blood vessel formation in tumor tissue. This agent also mildly inhibits c-Kit and c-SRC tyrosine kinases.
Study: NCT04277494

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: Clorethyl cold spray® (Vapocoolant spray)
Description: From the anterior superior of the dominant legs to the spinal iliac, the upper part of the patella will be measured and the center point will be marked. Cold spray will be applied to this point and its surroundings. The ethyl chloride spray bottle will be kept approximately 30 cm from the skin. An ethyl chloride stream will be applied at a 45 ° angle for 15 seconds (Shadgan et al., 2015). Skin temperature and mechanical properties of muscle; will be measured before, immediately after, 2 minutes, 5 minutes and 15 minutes after cold application.
Study: NCT01303471

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: opioid (remifentanyl)
Description: Infusion of remifentanyl (opioid) will be started at different levels for each group of the randomized study : 0 ng/ml (group 0), 1 ng/ml (group 1), 3 ng/ml (group 3) or 4 ng/ml (group 4)
Study: NCT01444404

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: AMG 820
Description: AMG 820 is a fully human IgG2 c-fms antagonistic antibody and will be given every two weeks until progression or unacceptable toxicity develops.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: AMG 820
Description: AMG 820 is a fully human IgG2 c-fms antagonistic antibody and will be given every two weeks until progression or unacceptable toxicity develops.
Study: NCT03491657

Intervention type: BEHAVIORAL
Group type: EXPERIMENTAL
Intervention: virtual reality distraction (Yes VR)

Intervention type: BEHAVIORAL
Group type: ACTIVE_COMPARATOR
Intervention: music distraction (No VR)
Study: NCT04063085

Intervention type: DEVICE
Group type: EXPERIMENTAL
Intervention: PROTAHERE Absorbable Adhesion Barrier
Description: 40 mg/ml (4%) cross-linked hyaluronan

Intervention type: DEVICE
Group type: ACTIVE_COMPARATOR
Intervention: Hyalobarrier Gel
Description: Laparotomy: 40 mg/ml (4%) cross-linked hyaluronan Endoscopy: 30 mg/ml (3%) cross-linked hyaluronan

Intervention type: OTHER
Group type: SHAM_COMPARATOR
Intervention: No treatment
Description: No anti-adhesion agent applied

Intervention type: DEVICE
Group type: ACTIVE_COMPARATOR
Intervention: Seprafilm Adhesion Barrier
Description: a hyaluronate carboxymethylcellulose-based bioresorbable membrane

Intervention type: DEVICE
Group type: ACTIVE_COMPARATOR
Intervention: Gynecare Interceed (TC7) Absorbable Adhesion Barrier
Description: an oxidized regenerated cellulose absorbable membrane
Study: NCT02658799

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: cataflam (diclofenac potassium)
Description: Cataflam (diclofenac potassium, 50 mg) b.i.d. after a meal for 6 months in a cyclic regimen. Administration of diclofenac potassium was undertaken from baseline to 2 months, no drug (diclofenac potassium or placebo) was administered from 2 to 4 months, then diclofenac potassium or placebo therapy was reinstituted (b.i.d.) from 4 to 6 months. To promote compliance, each patient was recalled monthly.

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: placebo
Description: Placebo gel caps (containing inactive filler of starch flour and carboxymethylcellulose) b.i.d. after a meal for 6 months in a cyclic regimen.~Administration of placebo was undertaken from baseline to 2 months, no drug (diclofenac potassium or placebo) was administered from 2 to 4 months, then diclofenac potassium or placebo therapy was reinstituted (b.i.d.) from 4 to 6 months. To promote compliance, each patient was recalled monthly.