TrialPanorama/TrialPanorama-database huggingface dataset:
Study: NCT02581813

Intervention type: BEHAVIORAL
Group type: EXPERIMENTAL
Intervention: I.D.E.A.L. for Adolescents Study - Higher Dairy
Description: 12 weeks diet and exercise intervention characterized by higher dairy consumption (4 servings per day) and exercise 3 times per week

Intervention type: BEHAVIORAL
Group type: EXPERIMENTAL
Intervention: I.D.E.A.L. for Adolescents Study - Lower Dairy
Description: 12 weeks diet and exercise intervention characterized by lower dairy consumption (0-1 serving per day) and exercise 3 times per week
Study: NCT00124943

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Nanoparticle Paclitaxel
Description: Nanoparticle albumin-bound paclitaxel, administered via intracoronary catheter.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Nanoparticle Paclitaxel
Description: Nanoparticle albumin-bound paclitaxel, administered via intracoronary catheter.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Nanoparticle Paclitaxel
Description: Nanoparticle albumin-bound paclitaxel, administered via intracoronary catheter.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Nanoparticle Paclitaxel
Description: Nanoparticle albumin-bound paclitaxel, administered via intracoronary catheter.
Study: NCT03063177

Intervention type: PROCEDURE
Group type: EXPERIMENTAL
Intervention: Spinal manipulative therapy
Description: A SMT will be delivered by contacting the transverse processes of T7 through our apparatus. Each participant will receive one SMT per session for 3 sessions.

Intervention type: PROCEDURE
Group type: EXPERIMENTAL
Intervention: Spinal manipulative therapy
Description: A SMT will be delivered by contacting the transverse processes of T7 through our apparatus. Each participant will receive one SMT per session for 3 sessions.

Intervention type: PROCEDURE
Group type: EXPERIMENTAL
Intervention: Spinal manipulative therapy
Description: A SMT will be delivered by contacting the transverse processes of T7 through our apparatus. Each participant will receive one SMT per session for 3 sessions.
Study: NCT01181063

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Budesonide/formoterol 320/9 μg and 400/12 μg inhalers
Description: Budesonide/formoterol 320/9 μg and 400/12 μg in different kind of inhalers and Symbicort Turbuhaler forte 320/9 μg. Ech subject will be randomly allocation to 4 of 5 products, a single dose administration of each product

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Budesonide/formoterol 320/9 μg and 400/12 μg inhalers
Description: Budesonide/formoterol 320/9 μg and 400/12 μg in different kind of inhalers and Symbicort Turbuhaler forte 320/9 μg. Ech subject will be randomly allocation to 4 of 5 products, a single dose administration of each product

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Budesonide/formoterol 320/9 μg and 400/12 μg inhalers
Description: Budesonide/formoterol 320/9 μg and 400/12 μg in different kind of inhalers and Symbicort Turbuhaler forte 320/9 μg. Ech subject will be randomly allocation to 4 of 5 products, a single dose administration of each product

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Budesonide/formoterol 320/9 μg and 400/12 μg inhalers
Description: Budesonide/formoterol 320/9 μg and 400/12 μg in different kind of inhalers and Symbicort Turbuhaler forte 320/9 μg. Ech subject will be randomly allocation to 4 of 5 products, a single dose administration of each product

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Budesonide/formoterol 320/9 μg and 400/12 μg inhalers
Description: Budesonide/formoterol 320/9 μg and 400/12 μg in different kind of inhalers and Symbicort Turbuhaler forte 320/9 μg. Ech subject will be randomly allocation to 4 of 5 products, a single dose administration of each product
Study: NCT01222689

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: erlotinib hydrochloride
Description: Given PO

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: selumetinib
Description: Given PO

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: laboratory biomarker analysis
Description: Correlative studies
Study: NCT03642587

Intervention type: OTHER
Intervention: There is no intervention in this study.
Description: There is no intervention in this study.
Study: NCT03980080

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: OSE-127
Description: mAb antagonist to CD127 receptor (or IL-7Rα)~Group 1-7~6 escalating dose level groups IV~SC

Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Placebo
Description: Vehicle study drug

Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Placebo
Description: Vehicle study drug
Study: NCT02391779

Intervention type: BEHAVIORAL
Group type: SHAM_COMPARATOR
Intervention: Dash Eating Plan
Description: Dietary Approaches to Stop Hypertension (DASH), a balanced eating plan - all participants in all treatment arms will be encouraged to adopt a DASH eating plan.

Intervention type: BEHAVIORAL
Group type: PLACEBO_COMPARATOR
Intervention: Dash Eating Plan
Description: Dietary Approaches to Stop Hypertension (DASH), a balanced eating plan - all participants in all treatment arms will be encouraged to adopt a DASH eating plan.
Study: NCT02486744

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Acthar Gel
Description: Subjects will be given an injection subcutaneously 2x week for 6 months. Dosing will be randomly assigned as either 80 U or 40 U

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Acthar Gel
Description: Subjects will be given an injection subcutaneously 2x week for 6 months. Dosing will be randomly assigned as either 80 U or 40 U
Study: NCT02941562

Intervention type: RADIATION
Group type: EXPERIMENTAL
Intervention: Short-course radiotherapy
Description: Preoperative Radiation doses: 25 Gy in 5 fractions to the pelvis

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: FOLFOX4 chemotherapy,preoperative
Description: FOLFOX4 chemotherapy：5-FU 400 mg/m2 i.v. bolus and Leucovorin 200 mg/m2 i.v. followed by 5-FU 600 mg/m2 i.v. 22 h-infusion day 1 + 2, oxaliplatin 85 mg/m2 day 1.~Repeat every 2 weeks

Intervention type: RADIATION
Group type: ACTIVE_COMPARATOR
Intervention: Radiotherapy of neo-adjuvant therapy
Description: Preoperative Radiation doses: 45 Gy in 25 fractions to the pelvis, 5.4 Gy in 3 fractions to the pelvis

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Concurrent chemotherapy of neo-adjuvant therapy
Description: Capecitabine 825mg/m2 twice daily 5 days/week

Intervention type: PROCEDURE
Group type: EXPERIMENTAL
Intervention: Radical rectal cancer resection
Description: Radical rectal cancer resection

Intervention type: PROCEDURE
Group type: ACTIVE_COMPARATOR
Intervention: Radical rectal cancer resection
Description: Radical rectal cancer resection

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: FOLFOX4 chemotherapy,post-operative
Description: FOLFOX4 chemotherapy：5-FU 400 mg/m2 i.v. bolus and Leucovorin 200 mg/m2 i.v. followed by 5-FU 600 mg/m2 i.v. 22 h-infusion day 1 + 2, oxaliplatin 85 mg/m2 day 1.~Repeat every 2 weeks

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: FOLFOX4 chemotherapy,post-operative
Description: FOLFOX4 chemotherapy：5-FU 400 mg/m2 i.v. bolus and Leucovorin 200 mg/m2 i.v. followed by 5-FU 600 mg/m2 i.v. 22 h-infusion day 1 + 2, oxaliplatin 85 mg/m2 day 1.~Repeat every 2 weeks
Study: NCT03813420

Intervention type: BEHAVIORAL
Group type: OTHER
Intervention: Pittsburgh Sleep Quality Index (PSQI)
Description: The sleep quality was evaluated through the Turkish version of the PSQI containing 19 self-rated questions searching the sleep quality during the previous month. It has seven components as subjective sleep quality, sleep latency, sleep duration, sleep efficiency, sleep disturbances, use of sleep medications, and daytime dysfunction.~Each component is scored from 0 to 3, and the Global Pittsburgh Quality of Sleep (PQS) score is the sum of the scores of the seven components that is between 0 and 21. The higher Global PQS scores indicate poor sleep quality and the cut off score for poor sleep is 5 and over.

Intervention type: BEHAVIORAL
Group type: OTHER
Intervention: International Physical Activity Questionnaire (IPAQ)
Description: The physical activity of the participants was assessed through the Turkish version of the International Physical Activity Questionnaire -Short Form (IPAQ-SF), which includes 6 questions searching the frequency (days per week) and duration (hours) of walking, as well as low, moderate and vigorous physical activity that they engaged in during the last seven days prior to survey. Vigorous physical activity, defined by the questionnaire, referred to intense exercise that resulted in very rapid breathing and an elevated heart rate (e.g. intense weight lifting, aerobics, running, and cycling). Moderate physical activity was defined as less intense exercise that slightly heightened breathing and heart rate (e.g. less exertive cycling, fast walking, and light weight lifting).

Intervention type: BEHAVIORAL
Group type: OTHER
Intervention: The Short Form 36 Health Survey (SF-36)
Description: The Turkish version of SF-36 was used to understand the health related quality-of -life (HRQOL) of the participants over the past four weeks in eight health concepts: limitations in physical activities because of health problems; limitations in social activities because of physical or emotional problems; limitations in usual role activities because of physical health problems; bodily pain; general mental health (psychological distress and well-being); limitations in usual role activities because of emotional problems; vitality (energy and fatigue); and general health perceptions. Additionally, the psychometric evaluation of the SF-36 generated two summary scores as the Mental Health Component Score and the Physical Health Component Score that the higher scores indicate better HRQOL.
Study: NCT03344653

Intervention type: DEVICE
Group type: ACTIVE_COMPARATOR
Intervention: Medtronic Resolute Onyx Zotarolimus-Eluting Coronary Stent System
Description: Medtronic Resolute Onyx Zotarolimus-Eluting Coronary Stent System Treatment Followed by 1 month DAPT

Intervention type: DEVICE
Group type: ACTIVE_COMPARATOR
Intervention: Biosensors BioFreedom BA9 Drug Coated Coronary Stent
Description: Biosensors BioFreedom BA9 Drug Coated Coronary Stent Followed by 1 month DAPT
Study: NCT02857166

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: humanized anti-PD-1 monoclonal antibody toripalimab
Description: humanized anti-PD-1 monoclonal antibody (JS001) is a programmed death-1 (PD-1) immune checkpoint inhibitor antibody, which selectively interferes with the combination of PD-1 with its ligands, PD-L1 and PD-L2, resulting in the activation of lymphocytes and elimination of malignancy theoretically.
Study: NCT01340651

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Ruxolitinib
Description: Ruxolitinib was supplied as SR and IR formulated tablets.
Study: NCT02513719

Intervention type: DEVICE
Intervention: XIENCE PRIME SV Everolimus Eluting Coronary Stent
Description: Patients receiving XIENCE PRIME SV Everolimus Eluting Stent
Study: NCT04421833

Intervention type: BEHAVIORAL
Group type: SHAM_COMPARATOR
Intervention: TOVERTAFEL
Description: The TOVERTAFEL is a small box that can be attached to the ceiling. Inside the box is a high-quality projector, infrared sensors, a speaker, and a processor that work together to project games onto the table. Because the colored objects respond to the movements of the hands and arms, the residents can play with the light itself.~The planned activities provide cognitive, social and physical stimulation through light projections and can all be used individually or in groups with the presence of a caregiver or facilitator. Sixteen play activities are offered.

Intervention type: BEHAVIORAL
Group type: ACTIVE_COMPARATOR
Intervention: TOVERTAFEL
Description: The TOVERTAFEL is a small box that can be attached to the ceiling. Inside the box is a high-quality projector, infrared sensors, a speaker, and a processor that work together to project games onto the table. Because the colored objects respond to the movements of the hands and arms, the residents can play with the light itself.~The planned activities provide cognitive, social and physical stimulation through light projections and can all be used individually or in groups with the presence of a caregiver or facilitator. Sixteen play activities are offered.

Intervention type: BEHAVIORAL
Group type: SHAM_COMPARATOR
Intervention: USUAL activities
Description: patients can participate in cooking workshops, cinema activities (screening of old films or documentaries on a large screen, in a cozy atmosphere), walks in the garden and the visit of a dog trained in assisted therapy by the animal.

Intervention type: BEHAVIORAL
Group type: ACTIVE_COMPARATOR
Intervention: USUAL activities
Description: patients can participate in cooking workshops, cinema activities (screening of old films or documentaries on a large screen, in a cozy atmosphere), walks in the garden and the visit of a dog trained in assisted therapy by the animal.
Study: NCT02948023

Intervention type: BIOLOGICAL
Group type: ACTIVE_COMPARATOR
Intervention: Ex-vivo cultivated limbal stem cell pool
Description: 0.5 million stromal and epithelial cells will be incorporated in 0.05ml of commercially available fibrin glue and pasted over the corneal lesion after epithelial debridement.
Study: NCT00617253

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: recombinant interleukin-21
Description: 3 mcg/kg, s.c. injection

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: sunitinib
Description: Hard gelatine capsules, 12.5 mg

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: sunitinib
Description: Hard gelatine capsules, 12.5 mg

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: sunitinib
Description: Hard gelatine capsules, 12.5 mg

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: sunitinib
Description: Hard gelatine capsules, 12.5 mg

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: recombinant interleukin-21
Description: 10 mcg/kg, s.c. injection

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: recombinant interleukin-21
Description: 30 mcg/kg, s.c. injection

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: recombinant interleukin-21
Description: 100 mcg/kg, s.c. injection
Study: NCT04581954

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Ruxolitinib
Description: Ruxolitinib is a Janus kinase 1 (JAK1)/Janus kinase 2 (JAK2) inhibitor approved for clinical use in the treatment of splenomegaly, myelofibrosis, polycythaemia vera and graft-versus-host disease. It is an oral agent with a rapid mode of action.

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Fostamatinib
Description: Fostamatinib is a tyrosine kinase inhibitor with activity against spleen tyrosine kinase (SYK). It has approved for the treatment of thrombocytopenia in adult patients with chronic immune thrombocytopenia (ITP).

Intervention type: OTHER
Group type: ACTIVE_COMPARATOR
Intervention: Standard of care
Description: Standard of care treatment as per site-level policies and guidelines.
Study: NCT02785471

Intervention type: BEHAVIORAL
Group type: ACTIVE_COMPARATOR
Intervention: Screening for Mental Health only
Description: Participants in the Screening for Mental Health (SMH)-only group will complete the online depression and suicide screening and receive immediate feedback and referrals.

Intervention type: BEHAVIORAL
Group type: EXPERIMENTAL
Intervention: Screening for Mental Health & Man Therapy
Description: Participants assigned to Screening for Mental Health, plus Man Therapy (SMH+MT) group will be offered the Man Therapy program in conjunction with Screening for Mental Health. MT provides online early intervention services designed specifically for men who are at risk for suicide and are less likely to engage in help-seeking behavior. MT takes an innovative and humorous approach to mental health education and help seeking through a fictional therapist named Dr. Rich Mahogany, who is a no-nonsense man's man who informs men about the importance of honest talk about life's challenges in addressing their problems. The web portal allows review manly mental health information, facts and tips, explore man therapies, and view videos of men with lived experience.
Study: NCT03834038

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Lyophilized Fecal Microbiota Transplantation
Description: Lyophilized FMT
Study: NCT03045068

Intervention type: BIOLOGICAL
Group type: ACTIVE_COMPARATOR
Intervention: Platelet Transfusion
Description: Post CPB- Platelet transfusion 20ml/kg via a central venous line is continued at a rate of 100 ml/hour till completion.~1. Initial transfusion to occur proximal to the hemofilter on the MUF circuit for as long as MUF lasts~2. Subsequent platelet transfusion continued till completion via central venous access to the patient

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: Platelet Transfusion
Description: Post CPB- Platelet transfusion 20ml/kg via a central venous line is continued at a rate of 100 ml/hour till completion.~1. Initial transfusion to occur proximal to the hemofilter on the MUF circuit for as long as MUF lasts~2. Subsequent platelet transfusion continued till completion via central venous access to the patient

Intervention type: BIOLOGICAL
Group type: ACTIVE_COMPARATOR
Intervention: FFP and Cryoprecipitate
Description: 1. 1 unit of cryoprecipitate administered during MUF and or after MUF as needed~2. FFP transfusion 10ml/kg during MUF and or after MUF as needed

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: FFP and Cryoprecipitate
Description: 1. 1 unit of cryoprecipitate administered during MUF and or after MUF as needed~2. FFP transfusion 10ml/kg during MUF and or after MUF as needed

Intervention type: BIOLOGICAL
Group type: ACTIVE_COMPARATOR
Intervention: PRBC and cell saver Transfusion
Description: 1. Transfuse for target Hematocrit \> 40 in neonates with SV physiology; Transfuse for Hematocrit\> 33 for 2-Ventricle physiology

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: PRBC and cell saver Transfusion
Description: 1. Transfuse for target Hematocrit \> 40 in neonates with SV physiology; Transfuse for Hematocrit\> 33 for 2-Ventricle physiology

Intervention type: BIOLOGICAL
Group type: ACTIVE_COMPARATOR
Intervention: Factor Concentrate (Bebulin)
Description: 1. Based on clinical bleeding and achievement of hemostasis

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: Factor Concentrate (Bebulin)
Description: 1. Based on clinical bleeding and achievement of hemostasis
Study: NCT06609382

Intervention type: OTHER
Intervention: Patients had a higher left ventricular mass index or not （the exact value is determined by the cut-off value for the clinical outcomes)
Description: Patients were grouped by the cutoff value of left ventricular mass index (LVMI) for all cause death, and the Maximally Selected Rank Statistics method was used to determine the optimal cutoff point of LVMI for death.
Study: NCT06609564

Intervention type: DEVICE
Group type: EXPERIMENTAL
Intervention: inspiratory muscle training
Description: Inspiratory muscle training with a pressure-adjustable device

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: Convantional chest physiotherapy
Description: Chest physiotherapy
Study: NCT01313117

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Alpha lipoic acid
Description: The baseline dose is 100 mg three times daily for four months. Dose escalation will occur until a maximum tolerated dose is found.
Study: NCT04665570

Intervention type: DRUG
Intervention: BAY81-9783 (Acarbose/Metformin)
Description: Tablet (FDC of 25/50mg acarbose + 500mg metformin), three times daily
Study: NCT04310384

Intervention type: DEVICE
Group type: ACTIVE_COMPARATOR
Intervention: ShuttleScope
Description: Alternative intervention

Intervention type: DEVICE
Group type: ACTIVE_COMPARATOR
Intervention: MacIntosh Laryngoscope
Description: Gold Standart
Study: NCT03224351

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: VX-659
Description: Tablet for oral administration.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: VX-659
Description: Tablet for oral administration.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: VX-659
Description: Tablet for oral administration.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: VX-659
Description: Tablet for oral administration.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: VX-659
Description: Tablet for oral administration.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: TEZ/IVA
Description: TEZ/IVA fixed-dose combination tablet for oral administration.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: TEZ/IVA
Description: TEZ/IVA fixed-dose combination tablet for oral administration.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: TEZ/IVA
Description: TEZ/IVA fixed-dose combination tablet for oral administration.

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: TEZ/IVA
Description: TEZ/IVA fixed-dose combination tablet for oral administration.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: TEZ/IVA
Description: TEZ/IVA fixed-dose combination tablet for oral administration.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: IVA
Description: Tablet for oral administration.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: IVA
Description: Tablet for oral administration.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: IVA
Description: Tablet for oral administration.

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: IVA
Description: Tablet for oral administration.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: IVA
Description: Tablet for oral administration.

Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Placebo (matched to VX-659/TEZ/IVA)
Description: Placebo matched to VX-659 and TEZ/IVA.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: TEZ
Description: Tablet for oral administration.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: VX-561
Description: Tablet for oral administration.

Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Placebo (matched to VX-659/TEZ/VX-561)
Description: Placebo matched to VX-659, TEZ and VX-561.
Study: NCT04541784

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: WOMAN-PRO III
Description: Standardized care and three counselling sessions with a gynaecology-oncology nurse and the use of the mobile app WOMAN-PRO III.

Intervention type: OTHER
Group type: ACTIVE_COMPARATOR
Intervention: Three counselling sessions with gynaecology-oncology nurses
Description: Standardized care, three counselling sessions with a gynaecology-oncology nurse.
Study: NCT01835938

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: 1- Erlotinib
Description: * Erlotinib 50 mg tablet by mouth every day for 14 days,~* Erlotinib 100 mg tablet by mouth every day for 14 days,~* Erlotinib 150 mg tablet by mouth every day for 14 days,

Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: placebo
Description: * Placebo 50 mg tablet by mouth every day for 14 days,~* Placebo 100 mg tablet by mouth every day for 14 days,~* Placebo 150 mg tablet by mouth every day for 14 days,