TrialPanorama/TrialPanorama-database huggingface dataset:
Study: NCT02388672

Intervention type: DIETARY_SUPPLEMENT
Group type: EXPERIMENTAL
Intervention: decaffeinated coffee
Description: Decaffeinated coffee with low chlorogenic acid (224mg; low-CGA)

Intervention type: DIETARY_SUPPLEMENT
Group type: PLACEBO_COMPARATOR
Intervention: decaffeinated coffee
Description: Decaffeinated coffee with low chlorogenic acid (224mg; low-CGA)

Intervention type: DIETARY_SUPPLEMENT
Group type: EXPERIMENTAL
Intervention: decaffeinated coffee
Description: Decaffeinated coffee with low chlorogenic acid (224mg; low-CGA)

Intervention type: DIETARY_SUPPLEMENT
Group type: PLACEBO_COMPARATOR
Intervention: decaffeinated coffee
Description: Decaffeinated coffee with low chlorogenic acid (224mg; low-CGA)

Intervention type: DIETARY_SUPPLEMENT
Group type: EXPERIMENTAL
Intervention: chlorogenic acid
Description: Decaffeinated coffee with high chlorogenic acid (560mg; high-CGA)

Intervention type: DIETARY_SUPPLEMENT
Group type: PLACEBO_COMPARATOR
Intervention: chlorogenic acid
Description: Decaffeinated coffee with high chlorogenic acid (560mg; high-CGA)

Intervention type: DIETARY_SUPPLEMENT
Group type: EXPERIMENTAL
Intervention: chlorogenic acid
Description: Decaffeinated coffee with high chlorogenic acid (560mg; high-CGA)

Intervention type: DIETARY_SUPPLEMENT
Group type: PLACEBO_COMPARATOR
Intervention: chlorogenic acid
Description: Decaffeinated coffee with high chlorogenic acid (560mg; high-CGA)

Intervention type: DIETARY_SUPPLEMENT
Group type: EXPERIMENTAL
Intervention: green coffee bean extract supplement
Description: Decaffeinated coffee together with green coffee bean extract supplement (560mg; high-CGA)

Intervention type: DIETARY_SUPPLEMENT
Group type: PLACEBO_COMPARATOR
Intervention: placebo
Description: Decaffeinated coffee with placebo capsules as control group for green coffee bean extract supplement (224mg; low-CGA)
Study: NCT03954704

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Dalutrafusp alfa
Description: Administered intravenously

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Dalutrafusp alfa
Description: Administered intravenously

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Dalutrafusp alfa
Description: Administered intravenously

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: mFOLFOX6 Regimen
Description: Chemotherapy regimen of oxaliplatin, 5-fluorouracil \[5-FU\], and leucovorin
Study: NCT00773630

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Cilostazol
Description: 100 mg Cilostazol

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Cilostazol
Description: 100 mg Cilostazol

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Cilostazol
Description: 100 mg Cilostazol

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Cilostazol
Description: 100 mg Cilostazol
Study: NCT04810637

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: GX-I7
Description: Recombinant human interleukin-7 hybrid Fc

Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: GX-I7
Description: Recombinant human interleukin-7 hybrid Fc
Study: NCT03954704

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Dalutrafusp alfa
Description: Administered intravenously
Study: NCT00996541

Intervention type: BEHAVIORAL
Group type: PLACEBO_COMPARATOR
Intervention: STRIVE family intervention
Description: Adolescent and parent attend a 5-session family-oriented cognitive-behavioral intervention aimed at giving runaway youths and their parents the tools to effectively deal with conflict.

Intervention type: BEHAVIORAL
Group type: EXPERIMENTAL
Intervention: STRIVE family intervention
Description: Adolescent and parent attend a 5-session family-oriented cognitive-behavioral intervention aimed at giving runaway youths and their parents the tools to effectively deal with conflict.
Study: NCT02279160

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: APD811

Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Placebo
Description: Placebo
Study: NCT01100658

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Methylphenidate
Description: 1 capsule each day for 1 week, .3 mg/kg dose.

Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Placebo
Description: 1 capsule per day for 1 week.
Study: NCT01572636

Intervention type: DRUG
Intervention: Laronidase
Description: Administered 0.58 mg/kg/dose intravenously (IV) once a week beginning 12 weeks before planned hematopoietic stem cell transplant (HSCT) and resume same dosing regimen for 8 weeks after HSCT.
Study: NCT01492816

Intervention type: BEHAVIORAL
Group type: EXPERIMENTAL
Intervention: Community Mobilization
Description: The proposed study seeks to continue C2P community mobilization efforts that have developed coalitions that plan for and bring about structural changes for purposes of reducing Human Immunodeficiency Virus (HIV) incidence and prevalence among youth in targeted communities at nine sites. Earlier phases of C2P have been outlined in ATN Protocols 016a, 016b, 040/040b. The C2P community mobilization model entails: determining a geographic area and population of focus for the coalitions to prioritize their planning and action (accomplished in an earlier phase of C2P); coalitions establishing a shared vision and mission; development of a strategic plan focused on structural changes to reduce risks associated with HIV; process documentation; and feedback as technical assistance to the coalitions.
Study: NCT00410345

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Mifepristone

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Mifepristone
Study: NCT00820690

Intervention type: DRUG
Intervention: cyclophosphamide
Description: 4 cycles AC: cyclophosphamide 600mg/m2
Study: NCT02405884

Intervention type: OTHER
Group type: OTHER
Intervention: Kowa HA-2 Perkins applanation tonometer.
Description: Patients were divided into groups according to the days on which they underwent hemodialysis. Intraocular pressure was measured with a Kowa HA-2 Perkins applanation tonometer. The tonometry included three measurements in the central region of the cornea before and after hemodialysis. In all patients, the measurements were performed three times on the days when hemodialysis sessions were performed, with 24 hours between each session, and the means of the measurements were obtained. All parameters were measured under prior corneal anesthesia with 0.1% proparacaine and 0.25% fluorescein eye drops.
Study: NCT02816411

Intervention type: DIETARY_SUPPLEMENT
Group type: EXPERIMENTAL
Intervention: Milk protein isolate
Description: Milk protein isolate in a powder form consisted of 80% casein and 20% whey protein. 20g were diluted into 500 ml water.~Placebo consisted of 365 ml water, 125 ml sugar-free cordial and 2g of low-calorie glucose/dextrose powder.

Intervention type: DIETARY_SUPPLEMENT
Group type: ACTIVE_COMPARATOR
Intervention: Placebo
Description: 500 mL drink that contained water (375 mL), sugar-free cordial (125 mL) and 2 g of low-calorie glucose/dextrose powder.
Study: NCT04012151

Intervention type: OTHER
Intervention: Physical measurement
Description: Parturients of gestational week \>= 32 weeks will have their arms and fingers measured to generate the conicity index.

Intervention type: OTHER
Intervention: Cuff size fitting
Description: Fit on arm cuff and finger cuff as selected by investigators based on the measurement.
Study: NCT00820690

Intervention type: DRUG
Intervention: paclitaxel
Description: 4 cycles T: paclitaxel 175mg/m2 after 4 AC
Study: NCT01899001

Intervention type: BEHAVIORAL
Group type: EXPERIMENTAL
Intervention: Cognitive Behavioral Therapy
Description: Participants will receive weekly, 30 minute sessions with a CBT-trained clinical psychologist for the first 8 weeks. Briefly, the purpose of CBT is to treat mood and associated anxiety disorders by changing dysfunctional thoughts that lead to negative mood states and maladaptive behaviors. Through the use of Socratic questioning, the therapist challenges the patient to observe the relationship between thoughts and feelings and to question the underlying beliefs that perpetuate negative affect. Ultimately, patients learns to recognize maladaptive automatic thoughts and develop a more rational and balanced way of thinking about themselves and the world around them.

Intervention type: BEHAVIORAL
Group type: EXPERIMENTAL
Intervention: Nutrition Counseling
Description: All women will receive nutrition/exercise counseling by a trained counselor. They will consume a self-selected diet of 1500-1800kcal/d of conventional foods based on the Food Guide Pyramid. Participants will also have an exercise goal that starts at 50 minutes per week and increases to 175 minutes per week. Sessions will teach standard weight loss skills, including self-monitoring, problem-solving, enlisting social support, and overcoming negative thoughts. Subjects will be asked to keep daily food intake and exercise logs which will be reviewed at the nutrition counseling sessions. These sessions will occur in person once weekly lasting on average 30 minutes for 16 sessions.

Intervention type: BEHAVIORAL
Group type: OTHER
Intervention: Nutrition Counseling
Description: All women will receive nutrition/exercise counseling by a trained counselor. They will consume a self-selected diet of 1500-1800kcal/d of conventional foods based on the Food Guide Pyramid. Participants will also have an exercise goal that starts at 50 minutes per week and increases to 175 minutes per week. Sessions will teach standard weight loss skills, including self-monitoring, problem-solving, enlisting social support, and overcoming negative thoughts. Subjects will be asked to keep daily food intake and exercise logs which will be reviewed at the nutrition counseling sessions. These sessions will occur in person once weekly lasting on average 30 minutes for 16 sessions.
Study: NCT01477073

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: FSH-GEX™

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: FSH-GEX™

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: FSH-GEX™

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: recombinant FSH

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: urinary FSH

Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Placebo
Study: NCT01525108

Intervention type: BEHAVIORAL
Group type: EXPERIMENTAL
Intervention: Self monitoring of blood pressure
Description: Electronic blood pressure device is provided for patients and he/she will be trained to measure blood pressure at home once daily(same time each day). A logbook is also provided to document the daily blood pressure level.

Intervention type: OTHER
Group type: ACTIVE_COMPARATOR
Intervention: Usual Care
Description: Four visits to the physician's office at 4th, 12th, 24th week in the study period with usual advice giving practice of the staff. At the end of the trial period, an electronic blood pressure device will be given to each patient in this arm.
Study: NCT01528436

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: Umbilical Cord Blood Infusion
Description: The subjects will be undertaken allogeneic umbilical cord blood infusion intravenously or intraarterially under non-myeloablative immunosuppression.

Intervention type: OTHER
Group type: ACTIVE_COMPARATOR
Intervention: Placebo Umbilical Cord Blood
Description: Placebo Umbilical Cord Blood that resembles cord blood in appearance was designed.

Intervention type: OTHER
Group type: ACTIVE_COMPARATOR
Intervention: Active Rehabilitation
Description: All subjects should participate in active rehabilitation. They will receive two physical and occupational therapy sessions per day. Post discharge, each participant should continue to receive rehabilitation therapy at least 3 days per week until the study completion.

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: Active Rehabilitation
Description: All subjects should participate in active rehabilitation. They will receive two physical and occupational therapy sessions per day. Post discharge, each participant should continue to receive rehabilitation therapy at least 3 days per week until the study completion.
Study: NCT01365091

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Saxagliptin/metformin fixed-dose combination (FDC)
Description: Tablet, oral, 5 mg/500 mg FDC, once on Day 1 only, 1 day

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Saxagliptin/metformin fixed-dose combination (FDC)
Description: Tablet, oral, 5 mg/500 mg FDC, once on Day 1 only, 1 day

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Saxagliptin
Description: Tablet, oral, 5 mg, once on Day 1 only, 1 day

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Saxagliptin
Description: Tablet, oral, 5 mg, once on Day 1 only, 1 day

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Saxagliptin
Description: Tablet, oral, 5 mg, once on Day 1 only, 1 day
Study: NCT00739908

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: CX157 (TriRima)
Description: Six capsules administered three times a day for six weeks.

Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Placebo
Description: Six capsules administered three times a day for six weeks.
Study: NCT01365091

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Saxagliptin
Description: Tablet, oral, 5 mg, once on Day 1 only, 1 day

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Metformin extended-release (XR)
Description: Tablet, oral, 500 mg, once on Day 1 only, 1 day

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Metformin extended-release (XR)
Description: Tablet, oral, 500 mg, once on Day 1 only, 1 day

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Saxagliptin/Metformin FDC
Description: Tablet, Oral, 5 mg/1000 mg FDC, once on Day 1 only, 1 day

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Saxagliptin/Metformin FDC
Description: Tablet, Oral, 5 mg/1000 mg FDC, once on Day 1 only, 1 day

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Metformin
Description: Tablet, oral, 1000 mg, once on Day 1 only, 1 day

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Metformin
Description: Tablet, oral, 1000 mg, once on Day 1 only, 1 day
Study: NCT05982444

Intervention type: PROCEDURE
Group type: OTHER
Intervention: water vapor thermal therapy (Rezum) for prostate
Description: all patients underwent rezum therapy for bph are evaluated for its effectiveness for long period
Study: NCT00592176

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: local injection of bevacizumab
Description: Upon enrollment into the study: - initial injection of bevacizumab, a 1 week post-injection visit,and monthly visits thereafter for a total of 6 months. At the 1-month and 3-month visit post-injection visit, an additional bevacizumab injection will be offered if pterygium regression has not occurred. All injections of bevacizumab will consist of injecting 0.1mL of a 2.5mg/0.1mL concentration of bevacizumab into the head of the pterygium.
Study: NCT00472043

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: PDT with Metvix 160 mg/g cream

Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Placebo
Study: NCT01404078

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Single Dose Polycap
Description: Low strength polycap contains Ace inhibitor; betablocker; thiazide diuretic; statin; aspirin
Study: NCT03946644

Intervention type: DEVICE
Group type: ACTIVE_COMPARATOR
Intervention: EVLA with keeping of securuty distance
Description: The EVLA will be performed with the 1470nm diode laser and a radial fibre (Leonardo® - 1470 nm/15W, Biolitec). The exact position of the catheter tip will be fixed under ultrasound guidance 2 cm below the SFJ.

Intervention type: DEVICE
Group type: EXPERIMENTAL
Intervention: EVLA without keeping a distance
Description: The EVLA will be performed with the 1470nm diode laser and a radial fibre (Leonardo® - 1470 nm/15W, Biolitec). The exact position of the catheter tip will be fixed under ultrasound guidance without keeping a distance to the SFJ.
Study: NCT02352090

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Ethinyl estradiol / dienogest
Description: One tablet orally for 9 weeks, continuous use

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Estradiol valerate / dienogest
Description: One tablet orally for 9 weeks, continuous use

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Dienogest
Description: One tablet orally for 9 weeks, continuous use
Study: NCT03828864

Intervention type: DEVICE
Group type: ACTIVE_COMPARATOR
Intervention: Pulsed Shortwave Therapy
Description: Pulsed Shortwave Therapy device placed over the site of pain for 16 hrs per day

Intervention type: DEVICE
Group type: PLACEBO_COMPARATOR
Intervention: Placebo Pulsed Shortwave Therapy
Description: Placebo Pulsed Shortwave Therapy device placed over the site of pain for 16 hrs per day
Study: NCT04344015

Intervention type: OTHER
Group type: OTHER
Intervention: Plasma Donation
Description: Previously infected COVID-19 patients will be recruited to donate convalescent plasma.
Study: NCT00820690

Intervention type: PROCEDURE
Intervention: Surgery
Description: The surgery will be performed 30 days after the chemotherapy. The correlation between clinical, radiologic and pathologic response will be reported.~The oncoplastic surgery rate will be reported
Study: NCT00729651

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: alendronate sodium (+) cholecalciferol
Description: Alendronate sodium/Cholecalciferol; tablet, once weekly, for 16 weeks
Study: NCT02364245

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: Traditional OT(30 Mins)
Description: Receive Traditional Occupational Therapy training for 30 minutes. There are 3 sections for 1 week; the intervention period will be 8 weeks.
Study: NCT00729651

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Comparator: Alendronate sodium (Fosamax)
Description: Alendronate sodium; tablet, once weekly, for 16 weeks

Intervention type: DIETARY_SUPPLEMENT
Group type: EXPERIMENTAL
Intervention: Comparator: Calcium
Description: 500 mg oral tablet calcium once daily, for 16 weeks

Intervention type: DIETARY_SUPPLEMENT
Group type: ACTIVE_COMPARATOR
Intervention: Comparator: Calcium
Description: 500 mg oral tablet calcium once daily, for 16 weeks
Study: NCT04418453

Intervention type: OTHER
Intervention: Integration of telemedicine for MOUD in primary care
Description: Patients with opioid use disorder in rural primary care settings may be referred to receive telemedicine for medication treatment for opioid use disorder
Study: NCT01119391

Intervention type: BEHAVIORAL
Intervention: There was no intervention; this was a survey only study
Description: There was no intervention; this was a survey only study
Study: NCT02399826

Intervention type: DEVICE
Group type: EXPERIMENTAL
Intervention: Offloading
Description: Provision of an offloading cam walker or cast boot, may also convert to total contact cast and add felt or foam to supplement

Intervention type: DEVICE
Group type: OTHER
Intervention: Offloading
Description: Provision of an offloading cam walker or cast boot, may also convert to total contact cast and add felt or foam to supplement

Intervention type: PROCEDURE
Group type: EXPERIMENTAL
Intervention: Dressing Application
Description: Application of a non adherent dressing, and a multi-layer compression dressing
Study: NCT02626546

Intervention type: PROCEDURE
Intervention: Major surgical procedure
Description: observation of postoperative outcomes
Study: NCT00996307

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: MF59-eH1N1_f
Description: 3.75 µg A/H1N1 antigen with 50% MF59 adjuvant administered on study day 1 and day 22.

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: MF59-eH1N1_f
Description: 7.5 µg A/H1N1 antigen without MF59 adjuvant administered on study day 1 and day 22.

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: MF59-eH1N1_f
Description: 15 µg A/H1N1 antigen without MF59 adjuvant administered on study day 1 and day 22.

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: MF59-eH1N1_f
Description: 7.5 µg A/H1N1 antigen with 50% MF59 adjuvant administered on study day 1 and day 22.
Study: NCT02364245

Intervention type: OTHER
Group type: PLACEBO_COMPARATOR
Intervention: Traditional OT(60 Mins)
Description: Receive Traditional Occupational Therapy training for 60 minutes. There are 3 sections for 1 week; the intervention period will be 8 weeks.
Study: NCT00391053

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: High-Dose Inactivated, Split-Virion Influenza Vaccine
Description: 0.5 mL, IM

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: High-Dose Inactivated, Split-Virion Influenza Vaccine
Description: 0.5 mL, IM

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: High-Dose Inactivated, Split-Virion Influenza Vaccine
Description: 0.5 mL, IM

Intervention type: BIOLOGICAL
Group type: ACTIVE_COMPARATOR
Intervention: Inactivated, Split-Virion Influenza Vaccine
Description: 0.5 mL, IM
Study: NCT02850224

Intervention type: BEHAVIORAL
Group type: EXPERIMENTAL
Intervention: Motivational interviewing to elicit PCO in pediatrics
Description: A motivational interviewing style webinar. Physicians watch the webinar, incorporate communication techniques.
Study: NCT03528655

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: Decision aid
Description: Decision aid is a tool that helps pregnant women become involved in decision making on choosing rooming-in or separation care. Decision aid provides information about the options and outcomes, and by clarifying personal values.
Study: NCT04667676

Intervention type: DEVICE
Group type: SHAM_COMPARATOR
Intervention: acupoint TENS
Description: TENS was applied bilaterally on acupoint Ex-B1, 4Hz frequency, and 200 μs pulse width and intensity was set at the best highest tolerable intensity by the patient sensitivity without a sensation of discomfort for 45 minutes, three times/week for four weeks

Intervention type: DEVICE
Group type: EXPERIMENTAL
Intervention: acupoint TENS
Description: TENS was applied bilaterally on acupoint Ex-B1, 4Hz frequency, and 200 μs pulse width and intensity was set at the best highest tolerable intensity by the patient sensitivity without a sensation of discomfort for 45 minutes, three times/week for four weeks
Study: NCT00335283

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Lansoprazole Tablet
Description: 40 mg bid x 16 weeks

Intervention type: PROCEDURE
Group type: ACTIVE_COMPARATOR
Intervention: PH and impedence testing
Description: 24 hour ph monitoring

Intervention type: PROCEDURE
Group type: PLACEBO_COMPARATOR
Intervention: PH and impedence testing
Description: 24 hour ph monitoring

Intervention type: PROCEDURE
Group type: ACTIVE_COMPARATOR
Intervention: manometry
Description: done prior to pH probe to measure length of esophagus

Intervention type: PROCEDURE
Group type: PLACEBO_COMPARATOR
Intervention: manometry
Description: done prior to pH probe to measure length of esophagus

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: lansoprazole
Description: 40mg bid

Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: placebo
Description: one tablet bid