TrialPanorama/TrialPanorama-database huggingface dataset:
Study: NCT05691478

Intervention type: PROCEDURE
Group type: ACTIVE_COMPARATOR
Intervention: Computed Tomography
Description: Undergo CT

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

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

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: Doxorubicin Hydrochloride
Description: Given IV

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Doxorubicin Hydrochloride
Description: Given IV

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Doxorubicin Hydrochloride
Description: Given IV

Intervention type: PROCEDURE
Group type: ACTIVE_COMPARATOR
Intervention: Magnetic Resonance Imaging
Description: Undergo MRI

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

Intervention type: PROCEDURE
Group type: ACTIVE_COMPARATOR
Intervention: Magnetic Resonance Imaging
Description: Undergo MRI

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

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

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Methotrexate
Description: Given IV

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

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Methotrexate
Description: Given IV

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

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

Intervention type: PROCEDURE
Group type: ACTIVE_COMPARATOR
Intervention: Surgical Procedure
Description: Undergo surgery

Intervention type: PROCEDURE
Group type: EXPERIMENTAL
Intervention: Surgical Procedure
Description: Undergo surgery

Intervention type: PROCEDURE
Group type: ACTIVE_COMPARATOR
Intervention: Surgical Procedure
Description: Undergo surgery

Intervention type: PROCEDURE
Group type: EXPERIMENTAL
Intervention: Surgical Procedure
Description: Undergo surgery

Intervention type: PROCEDURE
Group type: ACTIVE_COMPARATOR
Intervention: X-Ray Imaging
Description: Undergo X-ray

Intervention type: PROCEDURE
Group type: EXPERIMENTAL
Intervention: X-Ray Imaging
Description: Undergo X-ray

Intervention type: PROCEDURE
Group type: ACTIVE_COMPARATOR
Intervention: X-Ray Imaging
Description: Undergo X-ray

Intervention type: PROCEDURE
Group type: EXPERIMENTAL
Intervention: X-Ray Imaging
Description: Undergo X-ray

Intervention type: PROCEDURE
Group type: EXPERIMENTAL
Intervention: X-Ray Imaging
Description: Undergo X-ray
Study: NCT05136573

Intervention type: BEHAVIORAL
Group type: EXPERIMENTAL
Intervention: Combined Exercises
Description: Combined Exercises
Study: NCT05898867

Intervention type: OTHER
Intervention: Saline
Description: Open label intra-articular injection of isotonic saline.

Intervention type: OTHER
Intervention: Saline
Description: Open label intra-articular injection of isotonic saline.
Study: NCT04622696

Intervention type: DIAGNOSTIC_TEST
Intervention: Ultrasound imaging
Description: Subjects in the performance cohort will undergo ultrasound imaging to assess the visibility of the HydroMARK Breast Biopsy Marker at 6-12 weeks post-implant. There is no intervention in the safety cohort (retrospective chart review).
Study: NCT05293080

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: Medical or interventional therapy for rhythm control in atrial fibrillation (antiarrhythmic drugs, ablation, electric cardio version)
Description: Therapy for early rhythm control will be either by use of approved antiarrhythmic drugs (e.g. amiodarone, dronedarone, flecainide, propafenone), approved approaches and devices for ablation, or electric cardio version.

Intervention type: OTHER
Group type: ACTIVE_COMPARATOR
Intervention: Usual care for atrial fibrillation
Description: Usual care for atrial fibrillation according to current guidelines. Usual care will mainly comprise rate control by approved drugs. We expect, that usual care will also comprise therapy for rhythm control in a small group of patients.
Study: NCT05790733

Intervention type: OTHER
Group type: ACTIVE_COMPARATOR
Intervention: Standard intubation
Description: This involves the use of 5% Xylocaine nebulizer spray and a single-use cannula. The nurse checks its expiry date and that the quantity is sufficient to practice the 7 instillations in one nostril and the other 7 in the mouth. A waiting time is respected and the installation of the NGS can begin. She will also set up a fast for 2 hours after this local anesthesia.

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: Hypnosis
Description: Hypnosis is a particular psychological state marked by the functioning of the individual at a level of attention other than the ordinary state of consciousness. It can, under certain conditions, give the appearance of sleep or somnambulism without sharing all the characteristics.~As part of the treatment, hypnosis is widely used for pain control. The adverse effects reported are nil. One of its main benefits is improved patient comfort. Another benefit is the reduction of exposure to anesthetic products.~The installation of the NGS with hypnosis will be carried out according to the protocol set out in appendix 4.
Study: NCT05752123

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: ET-01
Description: Recruited participants will receive ET-01 IV infusion after conditioning.
Study: NCT05948605

Intervention type: DEVICE
Group type: ACTIVE_COMPARATOR
Intervention: Empower Neuromodulation System
Description: The Empower Neuromodulation System is designed to provide transcutaneous stimulation to the branches of a spinal nerve. The system comprised of three key components: (A) The Stimulator, (B) the Empower smartphone app, and (C) the Gel Patch. The smartphone application is used to coordinate treatment and record participant responses.

Intervention type: DEVICE
Group type: SHAM_COMPARATOR
Intervention: Empower Neuromodulation System
Description: The Empower Neuromodulation System is designed to provide transcutaneous stimulation to the branches of a spinal nerve. The system comprised of three key components: (A) The Stimulator, (B) the Empower smartphone app, and (C) the Gel Patch. The smartphone application is used to coordinate treatment and record participant responses.
Study: NCT05095779

Intervention type: BEHAVIORAL
Group type: EXPERIMENTAL
Intervention: Coaching calls
Description: OTH coaching calls

Intervention type: BEHAVIORAL
Group type: ACTIVE_COMPARATOR
Intervention: Coaching calls
Description: OTH coaching calls

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Nicotine replacement therapy
Description: 8 weeks of nicotine replacement therapy

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Nicotine replacement therapy
Description: 8 weeks of nicotine replacement therapy

Intervention type: BEHAVIORAL
Group type: EXPERIMENTAL
Intervention: Financial Incentives
Description: Escalating financial incentives for completing up to 5 coaching calls
Study: NCT04567537

Intervention type: DEVICE
Group type: ACTIVE_COMPARATOR
Intervention: Laser Treatment
Description: Patients will receive three laser treatments at one-month intervals.

Intervention type: DEVICE
Group type: ACTIVE_COMPARATOR
Intervention: Laser Treatment
Description: Patients will receive three laser treatments at one-month intervals.
Study: NCT04912102

Intervention type: DEVICE
Group type: ACTIVE_COMPARATOR
Intervention: high flow nasal oxygen device (HFNO)
Description: it is a novel technique by which heated humidified oxygen is supplied via nasal prongs at flow rates ranging from 40 to 70 L/minute. The Fio2 ranges from 0.21 to 1.0.

Intervention type: DEVICE
Group type: ACTIVE_COMPARATOR
Intervention: high flow nasal oxygen device (HFNO)
Description: it is a novel technique by which heated humidified oxygen is supplied via nasal prongs at flow rates ranging from 40 to 70 L/minute. The Fio2 ranges from 0.21 to 1.0.

Intervention type: DEVICE
Group type: ACTIVE_COMPARATOR
Intervention: high flow nasal oxygen device (HFNO)
Description: it is a novel technique by which heated humidified oxygen is supplied via nasal prongs at flow rates ranging from 40 to 70 L/minute. The Fio2 ranges from 0.21 to 1.0.
Study: NCT05698810

Intervention type: OTHER
Group type: OTHER
Intervention: CE marked Medical Device MagnetoEncephaloGraphy (MEG) usability
Description: tests

Intervention type: OTHER
Group type: OTHER
Intervention: CE marked Medical Device MagnetoEncephaloGraphy (MEG) usability
Description: tests

Intervention type: OTHER
Group type: OTHER
Intervention: CE marked Medical Device MagnetoEncephaloGraphy (MEG) usability
Description: tests

Intervention type: OTHER
Group type: OTHER
Intervention: CE marked Medical Device Magnetic Resonance Imaging (MRI) usability
Description: tests

Intervention type: OTHER
Group type: OTHER
Intervention: CE marked Medical Device Magnetic Resonance Imaging (MRI) usability
Description: tests

Intervention type: OTHER
Group type: OTHER
Intervention: CE marked Medical Device Magnetic Resonance Imaging (MRI) usability
Description: tests

Intervention type: OTHER
Group type: OTHER
Intervention: CE marked Medical Device ElectroEncephaloGraphy (EEG) usability
Description: tests

Intervention type: OTHER
Group type: OTHER
Intervention: CE marked Medical Device ElectroEncephaloGraphy (EEG) usability
Description: tests

Intervention type: OTHER
Group type: OTHER
Intervention: CE marked Medical Device ElectroEncephaloGraphy (EEG) usability
Description: tests

Intervention type: OTHER
Group type: OTHER
Intervention: CE marked Medical Device ElectroCardioGraphy (ECG) usability
Description: tests

Intervention type: OTHER
Group type: OTHER
Intervention: CE marked Medical Device ElectroCardioGraphy (ECG) usability
Description: tests

Intervention type: OTHER
Group type: OTHER
Intervention: CE marked Medical Device ElectroCardioGraphy (ECG) usability
Description: tests
Study: NCT05704075

Intervention type: PROCEDURE
Group type: EXPERIMENTAL
Intervention: Transverse Tibial Transport (TTT)
Description: Transverse tibial transport is a novel adaptation of concepts used in distraction histogenesis. The most common use of this surgical principle is in bone lengthening surgery, which is a well-established surgical procedure by applying an external fixator to the bone, creating a corticotomy, and gradually lengthening the bone at the optimal rate of 0.5mm/12hrs. The biological mechanisms of distraction histogenesis involve activating signalling pathways such as cytokines Interleukin 1 and Interleukin 6, pro-inflammatory markers TNF alpha, pro-osteogenic TGF-beta, BMPs and pro-angiogenic factors VEGF and angiopoietin . TTT utilises the concept of distraction histiogenesis, but distraction is performed in the transverse plane instead of a longitudinal distraction. In addition, the period of distraction is coupled with a corresponding compression period and ultimately results in no net change in limb length.

Intervention type: PROCEDURE
Group type: OTHER
Intervention: Conventional
Description: Dressing + Negative Pressure Wound Therapy
Study: NCT05525702

Intervention type: DEVICE
Group type: EXPERIMENTAL
Intervention: VRFS
Description: Participants wear VR headsets and experience immersive virtual environments, where their family members will be present and offer companionship and comfort.
Study: NCT06541262

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Silmitasertib
Description: Capsules

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Silmitasertib
Description: Capsules

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Silmitasertib
Description: Capsules

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Silmitasertib
Description: Capsules

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Irinotecan
Description: IV

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Irinotecan
Description: IV
Study: NCT05429762

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Tusamitamab ravtansine
Description: Pharmaceutical form: Concentrated solution for intravenous (IV) administration; Route of administration: IV infusion
Study: NCT05837910

Intervention type: DIETARY_SUPPLEMENT
Group type: EXPERIMENTAL
Intervention: Calm Active Study Product 1.1 Usage
Description: Participants will use their Radicle Calm Active Study Product 1.1 as directed for a period of 6 weeks.

Intervention type: DIETARY_SUPPLEMENT
Group type: EXPERIMENTAL
Intervention: Calm Active Study Product 1.2 Usage
Description: Participants will use their Radicle Calm Active Study Product 1.2 as directed for a period of 6 weeks.
Study: NCT06541262

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Irinotecan
Description: IV

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Irinotecan
Description: IV

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Temozolomide
Description: Oral

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Temozolomide
Description: Oral

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Temozolomide
Description: Oral

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Temozolomide
Description: Oral

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Vincristine
Description: IV

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Vincristine
Description: IV

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Vincristine
Description: IV
Study: NCT04159103

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: mRNA-3927
Description: mRNA-3927 dispersion for IV infusion
Study: NCT05296928

Intervention type: PROCEDURE
Group type: ACTIVE_COMPARATOR
Intervention: laparoscopic incision
Description: laparoscopic umbilical trocar entry pathways

Intervention type: PROCEDURE
Group type: EXPERIMENTAL
Intervention: laparoscopic incision
Description: laparoscopic umbilical trocar entry pathways
Study: NCT06116266

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: Education and support for primary care providers (PCPS)
Description: All PCPs in the EUC and Co-Care arms receive brief education on SUD treatment, including medications for OUD and AUD and contingency management for StUD, and recognizing and counteracting stigma while caring for patients with SUD.

Intervention type: OTHER
Group type: ACTIVE_COMPARATOR
Intervention: Education and support for primary care providers (PCPS)
Description: All PCPs in the EUC and Co-Care arms receive brief education on SUD treatment, including medications for OUD and AUD and contingency management for StUD, and recognizing and counteracting stigma while caring for patients with SUD.

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: Nurse Care Manager (NCM) visits
Description: A full-time clinic-embedded nurse care manager who works with patients and their PCPs to facilitate and support patient engagement in evidence-based treatment for polysubstance use and management of associated health conditions

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: Addiction specialist consultant
Description: An addiction specialist consultant who supports the nurse care manager and PCP in formulating and adjusting treatment plans

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: Health coaching sessions
Description: Health coaches who use motivational interviewing and cognitive behavioral therapy to motivate and support patients in behavior change to reduce polysubstance use-related harms. Patients may receive up to 12 health coaching sessions in total. The sessions will occur via phone and/or HIPAA compliant video chat software.

Intervention type: OTHER
Group type: ACTIVE_COMPARATOR
Intervention: Patient educational materials
Description: Patient participants receive an educational pamphlet addressing overdose prevention, information about accessing naloxone, and local SUD treatment options.
Study: NCT04871529

Intervention type: PROCEDURE
Group type: EXPERIMENTAL
Intervention: Therapeutic Conventional Surgery
Description: Undergo surgery

Intervention type: PROCEDURE
Group type: EXPERIMENTAL
Intervention: Therapeutic Conventional Surgery
Description: Undergo surgery

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

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Gemcitabine Hydrochloride
Description: Given IV

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Carboplatin
Description: Given IV
Study: NCT06486454

Intervention type: DEVICE
Intervention: HistoSonics Edison System
Description: Histotripsy with the HistoSonics Edison System for the full or partial destruction of liver tumors
Study: NCT05094271

Intervention type: OTHER
Group type: ACTIVE_COMPARATOR
Intervention: Supplemental Oxygen
Description: Subjects will be instrumented with a nasal cannula to receive 2L/min supplemental oxygen. The oxygen will be kept at a fixed rate, however, the participant will be titrated to receive a max of 4 liters per min to maintain sats \>90% based on oximetry readings.

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: Supplemental Oxygen
Description: Subjects will be instrumented with a nasal cannula to receive 2L/min supplemental oxygen. The oxygen will be kept at a fixed rate, however, the participant will be titrated to receive a max of 4 liters per min to maintain sats \>90% based on oximetry readings.

Intervention type: DEVICE
Group type: EXPERIMENTAL
Intervention: Continuous Positive Airway Pressure Machine
Description: Continuous positive airway pressure is a form of positive airway pressure ventilation in which a constant level of pressure greater than atmospheric pressure is continuously applied to the upper respiratory tract of a person.

Intervention type: OTHER
Group type: PLACEBO_COMPARATOR
Intervention: Room Air
Description: Subjects will be instrumented with a nasal cannula to receive 2L/min pressurized room air. The room air will be kept at a fixed rate, however, the participant will be titrated to receive a max of 4 liters per min to maintain sats \>90% based on oximetry readings.
Study: NCT03456193

Intervention type: PROCEDURE
Group type: EXPERIMENTAL
Intervention: LA transplant
Description: The proposed study treatment will include three central components:~* Harvest of the left atrium and pulmonary veins from a suitable donor~* Excision of the left atrium and portions of stenotic pulmonary veins from the patient with pulmonary vein stenosis~* Implantation of the donor posterior left atrium and portions of pulmonary veins into the patient.
Study: NCT04405596

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Ambroxol Hydrochloride
Description: The treatment regimen consists of a titration phase and a maintenance phase. Participants begin the titration phase (Weeks 1 and 2) taking 6 capsules a day (450mg or 0 mg) divided BID (3 capsules in the morning and 3 capsules in the evening). The first medication dose will be taken at the end of Baseline visit and in the presence of the study Neurologist. Possible side effects will be observed for 30 minutes. Medication dose will increase bi-weekly to 12 capsules on Weeks 3 and 4, and 18 capsules on Weeks 5 and 6 divided BID. At the end of titration (Week 5) participants will have reached a maximum of 1350mg or 0mg per day, depending on group allocation. In the maintenance phase, participants will remain in their maximum dose (1350mg or 0mg) from Week 5 to Week 52 (End of Trial).

Intervention type: OTHER
Group type: PLACEBO_COMPARATOR
Intervention: Placebo
Description: The treatment regimen consists of a titration phase and a maintenance phase. Participants begin the titration phase (Weeks 1 and 2) taking 6 capsules a day (450mg or 0 mg) divided BID (3 capsules in the morning and 3 capsules in the evening). The first medication dose will be taken at the end of Baseline visit and in the presence of the study Neurologist. Possible side effects will be observed for 30 minutes. Medication dose will increase bi-weekly to 12 capsules on Weeks 3 and 4, and 18 capsules on Weeks 5 and 6 divided BID. At the end of titration (Week 5) participants will have reached a maximum of 1350mg or 0mg per day, depending on group allocation. In the maintenance phase, participants will remain in their maximum dose (1350mg or 0mg) from Week 5 to Week 52 (End of Trial).
Study: NCT05789433

Intervention type: BEHAVIORAL
Group type: EXPERIMENTAL
Intervention: Aerobic exercise
Description: Moderate- to vigorous-intensity aerobic exercise

Intervention type: BEHAVIORAL
Group type: SHAM_COMPARATOR
Intervention: Progressive stretching
Description: Statistic stretching of eight major muscle groups
Study: NCT05837910

Intervention type: DIETARY_SUPPLEMENT
Group type: EXPERIMENTAL
Intervention: Calm Active Study Product 1.3 Usage
Description: Participants will use their Radicle Calm Active Study Product 1.3 as directed for a period of 6 weeks.

Intervention type: DIETARY_SUPPLEMENT
Group type: PLACEBO_COMPARATOR
Intervention: Placebo Control Form 1
Description: Participants will use their Placebo Control Form 1 as directed for a period of 6 weeks.

Intervention type: DIETARY_SUPPLEMENT
Group type: PLACEBO_COMPARATOR
Intervention: Placebo Control Form 2
Description: Participants will use their Placebo Control Form 2 as directed for a period of 6 weeks.

Intervention type: DIETARY_SUPPLEMENT
Group type: EXPERIMENTAL
Intervention: Calm Active Study Product 2.1 Usage
Description: Participants will use their Radicle Calm Active Study Product 2.1 as directed for a period of 6 weeks.
Study: NCT05875519

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Local anaesthesia with vasocontrictor (Mepivacaine hydrochloride 20 mg (2%) + Levonordefrin hydrochloride 0.06 mg)
Description: Mepivacaine hydrochloride 20 mg (2%) + Levonordefrin hydrochloride 0.06 mg

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Local anaesthesia with vasocontrictor (Mepivacaine hydrochloride 20 mg (2%) + Levonordefrin hydrochloride 0.06 mg)
Description: Mepivacaine hydrochloride 20 mg (2%) + Levonordefrin hydrochloride 0.06 mg
Study: NCT05378633

Intervention type: RADIATION
Group type: EXPERIMENTAL
Intervention: SRS
Description: Stereotactic Radiotherapy (SRS)

Intervention type: RADIATION
Group type: OTHER
Intervention: Whole Brain Radiotherapy
Description: Whole Brain Radiotherapy (WBRT)
Study: NCT05837910

Intervention type: DIETARY_SUPPLEMENT
Group type: PLACEBO_COMPARATOR
Intervention: Placebo Control Form 3
Description: Participants will use their Placebo Control Form 3 as directed for a period of 6 weeks.

Intervention type: DIETARY_SUPPLEMENT
Group type: EXPERIMENTAL
Intervention: Calm Active Study Product 3.1 Usage
Description: Participants will use their Radicle Calm Active Study Product 3.1 as directed for a period of 6 weeks.

Intervention type: DIETARY_SUPPLEMENT
Group type: PLACEBO_COMPARATOR
Intervention: Placebo Control Form 4
Description: Participants will use their Placebo Control Form 4 as directed for a period of 6 weeks.

Intervention type: DIETARY_SUPPLEMENT
Group type: EXPERIMENTAL
Intervention: Calm Active Study Product 4.1 Usage
Description: Participants will use their Radicle Calm Active Study Product 4.1 as directed for a period of 6 weeks.
Study: NCT05800938

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Isosorbid mononitrate
Description: Imdur tablets were given twice daily for 4 weeks

Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Placebo
Description: Placebo tablets were given twice daily for 4 weeks