TrialPanorama/TrialPanorama-database huggingface dataset:
Study: NCT02979587

Intervention type: DEVICE
Group type: OTHER
Intervention: Harmony TPV System
Description: The Harmony™ TPV (Model NTPV0022) is comprised of a 22mm porcine pericardium valve, sewn to a polyester-covered nitinol frame.~The Harmony TPV 25 and mTPV 25 (Model HTPV254952 and HTPV254252, respectively) is comprised of a 25mm porcine pericardium valve, sewn to a polyester covered asymmetrical hourglass nitinol frame with larger diameter inflow and outflow as well as shorter length compared to TPV 22 (Harmony TPV 25 Model HTPV254952 is not applicable for Continued Clinical Experience).~The Harmony Delivery System (DS) for the TPV 22, TPV 25, and mTPV 25 (NTPVDS0022 and HTPVDS0025) are all 25 Fr delivery systems using a coil loading catheter.
Study: NCT03218969

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Ecopipam
Description: oral drug in subjection currently experiencing dopamine agonist induced augmentation

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Ecopipam
Description: oral drug in subjection currently experiencing dopamine agonist induced augmentation

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Placebo
Description: matching placebo

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Placebo
Description: matching placebo
Study: NCT00657267

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Temozolomide
Description: Taken orally daily for the first three weeks of a four-week cycle.
Study: NCT04302116

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Combination therapy with vigabatrin and prednisolone
Description: High dose prednisolone (40 - 60 mg/day) for 1 month combined with vigabatrin treatment (50-150 mg/kg/day) twice daily for 4 months

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Vigabatrin Tablets
Description: Vigabatrin (50-150 mg/kg/day) twice daily for 4 months
Study: NCT01879007

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Factive® Tab / Factive IV

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Factive® Tab / Factive IV
Study: NCT03622047

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Dexmedetomidine ropivacaine
Description: Observing the effect of 0.5 μ g / ml sufentanil+ 0.1 % ropivacaine with 2 hours after fetal delivery, and the patients leave the delivery room without abnormality.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Dexmedetomidine ropivacaine
Description: Observing the effect of 0.5 μ g / ml sufentanil+ 0.1 % ropivacaine with 2 hours after fetal delivery, and the patients leave the delivery room without abnormality.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Dexmedetomidine ropivacaine
Description: Observing the effect of 0.5 μ g / ml sufentanil+ 0.1 % ropivacaine with 2 hours after fetal delivery, and the patients leave the delivery room without abnormality.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: No analgesia labor
Description: No analgesia labor control group

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: No analgesia labor
Description: No analgesia labor control group

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: No analgesia labor
Description: No analgesia labor control group
Study: NCT02152189

Intervention type: OTHER
Intervention: Screening for Fabry disease
Study: NCT02265276

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Saroglitazar
Description: Tab Saroglitazar 4 mg oral daily for 24 weeks

Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Pioglitazone
Description: Tab Pioglitazone 30 mg oral daily for 24 weeks
Study: NCT01083017

Intervention type: BEHAVIORAL
Intervention: motivational intervention for non-compliant individuals
Description: motivational interview(s) vs. repeated calls vs. no particular intervention
Study: NCT00412321

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: CNTO 328
Description: Patients will receive administrations of CNTO 328 with dose ranging from 3 mg/kg to 12 mg/kg weekly, every 2 or 3 weeks till Day 43 in cohorts 1 to 6. After cohort 6, if the clinical response is found to be suboptimal, the patients will receive 9 mg/kg or 12 mg/kg every 3 weeks in cohorts 7a. Participants in Cohort 7a who will experience intolerable toxicity after escalating to or receiving 12 mg/kg every 3 weeks will have the option of reverting to a dose of 9 mg/kg every 3 weeks if the investigator felt it was clinically indicated. In cohort 7b participants will receive 12 mg/kg CNTO 328 every 3 weeks.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: CNTO 328
Description: Patients will receive administrations of CNTO 328 with dose ranging from 3 mg/kg to 12 mg/kg weekly, every 2 or 3 weeks till Day 43 in cohorts 1 to 6. After cohort 6, if the clinical response is found to be suboptimal, the patients will receive 9 mg/kg or 12 mg/kg every 3 weeks in cohorts 7a. Participants in Cohort 7a who will experience intolerable toxicity after escalating to or receiving 12 mg/kg every 3 weeks will have the option of reverting to a dose of 9 mg/kg every 3 weeks if the investigator felt it was clinically indicated. In cohort 7b participants will receive 12 mg/kg CNTO 328 every 3 weeks.
Study: NCT02728349

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Chlorogenic acid
Description: Chlorogenic acid for injection is polyphenols, micromolecular and un-endogenous substance. It might play the role of cancer treatment via balancing tumor micro-environmental immune status according to the stability and rationality of immunodeficiency and endogenous immune material expression around the tumor. Chlorogenic acid for injection is made from chlorogenic acid (purity≥98%) which is extracted from folium cortex eucommiae.Chlorogenic acid and its preparations have not been reported as chemical drug and marketed around the world.
Study: NCT03213327

Intervention type: DEVICE
Group type: OTHER
Intervention: StayOk web application
Description: Patients fill in the questionnaires of the web application and receive an analyzed profile of their psychosocial condition and health-promoting advices
Study: NCT05619861

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: CAR-T
Description: Patients will receive CAR-T treatment
Study: NCT02380209

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: CEST MRI
Description: CEST MRI will be performed on patients prior to surgical resection of their tumor
Study: NCT03611205

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

Intervention type: PROCEDURE
Group type: EXPERIMENTAL
Intervention: Positron Emission Tomography
Description: Undergo dPET/CT
Study: NCT00551980

Intervention type: BEHAVIORAL
Group type: EXPERIMENTAL
Intervention: Cognitive, Relaxation, Exercise Therapy
Description: The intervention consists of brief shoulder and neck exercises to be performed several times a day, a relaxation exercise and instructions of how to reduce hyperfunction of the craniofacial and cervical muscles during the day
Study: NCT05592925

Intervention type: DIAGNOSTIC_TEST
Intervention: coagulation-related factors
Description: We retrospectively evaluated the relationship between lymph node metastasis and coagulation-related factors in 516 patients with T4a stage gastric cancer.

Intervention type: DIAGNOSTIC_TEST
Intervention: coagulation-related factors
Description: We retrospectively evaluated the relationship between lymph node metastasis and coagulation-related factors in 516 patients with T4a stage gastric cancer.
Study: NCT04112069

Intervention type: DEVICE
Group type: EXPERIMENTAL
Intervention: iLet Bionic Pancreas insulin-only configuration with Humalog or Novolog
Description: iLet Bionic Pancreas insulin-only configuration with Humalog or Novolog

Intervention type: OTHER
Group type: ACTIVE_COMPARATOR
Intervention: Usual Care
Description: Usual care
Study: NCT04540822

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: peripheral venous catheter with compress under the catheter-extension tube junction
Description: Placement of a BD Insyte® type catheter of 20 to 24 Gauge calibre on a peripheral vein located in the crease of the elbow or top of the hand or scalp or top of the foot. The catheter is placed while respecting the detersion and disinfection of the skin with the appropriate products and according to the procedure in force in the department. Once the venous return has been checked, a 10 cm extension with a BECTON-DIC® 3-way valve will be connected, which is previously purged with 0.9% Sodium Chloride. Under the catheter-extension tube junction will be inserted a sterile non-woven compress, cut sterilely (3.5x1.5 cm). The assembly will be held in place by a transparent sterile semi-permeable adhesive dressing such as Tegaderm® (5x7 cm). This area will be secured by placing a crepe bandage (crepe bandage 4 m x7 cm).

Intervention type: OTHER
Group type: ACTIVE_COMPARATOR
Intervention: peripheral venous catheter without compress under the catheter-extension tube junction
Description: Placement of a BD Insyte® type catheter of 20 to 24 Gauge calibre on a peripheral vein located in the crease of the elbow or top of the hand or scalp or top of the foot. The catheter is placed while respecting the detersion and disinfection of the skin with the appropriate products and according to the procedure in force in the department. Once the venous return has been checked, a 10 cm extension with a BECTON-DIC® 3-way valve will be connected, which is previously purged with 0.9% Sodium Chloride. No compresses will be inserted under the catheter-extension tube junction.The assembly will be held in place by a transparent sterile semi-permeable adhesive dressing such as Tegaderm® (5x7 cm). This area will be secured by placing a crepe bandage (crepe bandage 4 m x7 cm).
Study: NCT04682483

Intervention type: DRUG
Intervention: Vasopressor
Description: The vasopressors include phenylephrine, norepinephrine, epinephrine, dopamine and vasopressin.

Intervention type: DRUG
Intervention: Inotrope
Description: Inotropes include dobutamine and milrinone.

Intervention type: DEVICE
Intervention: Acute Mechanical Circulatory Support Devices
Description: Acute Mechanical Circulatory Support devices include ECMO (VV), ECMO (VA), Impella CP, Impella 2.5, Impella 5.0, Impella 5.5, Impella RP, IABP, Centrimag, Tandem Heart and ProTek Duo.
Study: NCT02906735

Intervention type: PROCEDURE
Intervention: Surgery
Description: Implantation of knee joint prosthesis or deviation osteotomies of the knee
Study: NCT01565148

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: iCo-007 350 mcg
Description: iCo-007 (350 μg) as an intravitreal injection at baseline followed by another iCo-007 dose (350 μg) at month 4

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: iCo-007 700 mcg
Description: iCo-007 (700 μg) as an intravitreal injection at baseline followed by another iCo-007 dose (700 μg) at month 4

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: iCo-007 350 mcg and Laser
Description: iCo-007 (350 μg) as an intravitreal injection at baseline followed 7 days later by laser photocoagulation. At M4, intravitreal injection of iCo-007 (350 μg) will be given as mandatory treatment. If the eye also meets retreatment criteria, it will also receive the second laser photocoagulation

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Ranibizumab and iCo-007 350 mcg
Description: Ranibizumab (0.5 mg) intravitreal injection at baseline followed by iCo-007 (350 μg) intravitreal injection 2 weeks later; re-treatment with ranibizumab (0.5 mg) mandatory at M4 followed by iCo-007 (350 μg) 2 weeks later
Study: NCT02414412

Intervention type: DIETARY_SUPPLEMENT
Group type: PLACEBO_COMPARATOR
Intervention: Ulmus macrocarpa water extract

Intervention type: DIETARY_SUPPLEMENT
Group type: ACTIVE_COMPARATOR
Intervention: Ulmus macrocarpa water extract
Study: NCT03560934

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Dronabinol
Description: Single dose oral administration of 10-60mg dronabinol prior to night 2 or 3 sleep in the clinical laboratory.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Dronabinol
Description: Single dose oral administration of 10-60mg dronabinol prior to night 2 or 3 sleep in the clinical laboratory.
Study: NCT02528188

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: NSAID
Description: Orally administered NSAID (naproxen 500 mg, celecoxib 100 mg or diclofenac 75 mg) twice daily for 56 weeks

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: Tanezumab 2.5 mg
Description: Subcutaneous injection of tanezumab 2.5 mg every 8 weeks for 56 weeks

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: Tanezumab 5 mg
Description: Subcutaneous injection of tanezumab 5 mg every 8 weeks for 56 weeks
Study: NCT02000349

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: PGD
Description: PGD using Next generation sequencing

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: PGD
Description: PGD using Next generation sequencing
Study: NCT00505791

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Nesiritide
Description: Study drug will be administered for 24 hours. Study drug will be initiated with a 2-µg/kg loading bolus followed by .01-µg/kg/min infusion. This may be increased at a rate of .005-µg/kg/min. every 3 hours until maximum dose of .03-µg/kg/min. Any increase in the infusion rate will be preceded by a 1-µg/kg bolus and increases in infusion rates will be permitted only in patients who have a systolic blood pressure \> 100 mmHg.

Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Nesiritide
Description: Study drug will be administered for 24 hours. Study drug will be initiated with a 2-µg/kg loading bolus followed by .01-µg/kg/min infusion. This may be increased at a rate of .005-µg/kg/min. every 3 hours until maximum dose of .03-µg/kg/min. Any increase in the infusion rate will be preceded by a 1-µg/kg bolus and increases in infusion rates will be permitted only in patients who have a systolic blood pressure \> 100 mmHg.
Study: NCT02647268

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Oxytocin
Description: Oxytocin, 10-5M solution

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Magnesium Sulphate
Description: Magnesium sulphate, 3.5mM solution

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Magnesium Sulphate
Description: Magnesium sulphate, 3.5mM solution
Study: NCT00991107

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: HE3286
Description: HE3286 20 mg (10 mg BID) for 28 days
Study: NCT00519389

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: H5N1 VLP Vaccine
Description: Two doses - Day 0 \& Day 28

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: H5N1 VLP Vaccine
Description: Two doses - Day 0 \& Day 28

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: H5N1 VLP Vaccine
Description: Two doses - Day 0 \& Day 28

Intervention type: BIOLOGICAL
Group type: PLACEBO_COMPARATOR
Intervention: Placebo
Description: Two doses - Day 0 \& Day 28
Study: NCT02575560

Intervention type: OTHER
Intervention: history data
Description: history data of PFS after 1st line or second line theray
Study: NCT00095667

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: lapatinib ditosylate
Description: Given orally

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: laboratory biomarker analysis
Description: Correlative studies
Study: NCT01579916

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: Trivalent Influenza Virus Vaccine
Description: Trivalent vaccine is supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose phosphate buffer, egg allantoic fluid and approximately 10\^7 FFU (fluorescent focus units) of each of 3 cold-adapted, attenuated 6:2 reassortant influenza strains: A/H1N1 (A/California/7/2009), A/H3N2 (A/Victoria/361/2011), B (B Wisconsin/1/2010). A single dose of investigational product was administered on Day 1.

Intervention type: OTHER
Group type: PLACEBO_COMPARATOR
Intervention: Placebo
Description: Placebo is suppllied in intranasal sprayers containing 0.5 mL of sucrose-phosphate buffer. A single dose of investigational product was administered on Day 1.
Study: NCT04301596

Intervention type: OTHER
Intervention: Collection of data
Description: different set of data will be collected over a 6 months period
Study: NCT02399943

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Trametinib

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Panitumumab
Study: NCT01591759

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Citicoline
Description: 2,000mg/day of citicoline taken as twice daily unit doses of 1,000 mg for the 8-week period of the clinical trial

Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Placebo
Description: Placebo arm of single-blind study
Study: NCT01376284

Intervention type: DRUG
Intervention: Dutasteride
Description: Collection of safety data
Study: NCT04219657

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: mesenchymal stem cell application

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: mesenchymal stem cell application
Study: NCT03643835

Intervention type: DEVICE
Group type: EXPERIMENTAL
Intervention: Thermal Rehab Machine
Description: The Polar Breeze unit is a microenvironmental air-chiller. That means it is a single-pass air-conditioner capable of cooling external air

Intervention type: OTHER
Group type: ACTIVE_COMPARATOR
Intervention: Forearm Ice Towels
Description: Towels that are wetted with ice water and wrapped around participants forearms (length of arm from wrist to elbow)
Study: NCT01321814

Intervention type: BEHAVIORAL
Group type: EXPERIMENTAL
Intervention: Cognitive behavioural therapy
Description: 6 sessions by licensed psychologist, including psychoeducation, exposure therapy, applied relaxation and behavioral activation.
Study: NCT01847443

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Nicotine (2 mg)
Description: 2 mg nicotine gum in two formulations
Study: NCT01083017

Intervention type: DRUG
Intervention: standardized anti-hypertensive treatment
Description: olmesartan, amlodipine, chlorthalidone, +- spironolactone
Study: NCT03362996

Intervention type: DIETARY_SUPPLEMENT
Group type: EXPERIMENTAL
Intervention: Freshly-Pressed Extra Virgin Olive Oil
Description: Dietary Supplement: Freshly-pressed extra virgin olive oil Freshly-Pressed Extra Virgin Olive Oil Aluminum bottle with 500 ml of freshly-pressed extra virgin olive oil 1 bottle per 10 days

Intervention type: COMBINATION_PRODUCT
Group type: PLACEBO_COMPARATOR
Intervention: extra virgin olive oil
Description: Extra Virgin Olive Oil Aluminum bottle with 500 ml of freshly-pressed extra virgin olive oil 1 bottle per 10 days

Intervention type: OTHER
Group type: OTHER
Intervention: mediterranean diet
Description: 50 patients that will have the same dietary habits and a Mediterranean dietary protocol
Study: NCT01408563

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Fludarabine
Description: 30 mg/m2/day IV x 6 days

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Melphalan
Description: 100 mg/m2/day IV x 1 day

Intervention type: RADIATION
Group type: EXPERIMENTAL
Intervention: Total Body Radiation
Description: 200 cGy on Day 0
Study: NCT03573739

Intervention type: PROCEDURE
Group type: EXPERIMENTAL
Intervention: low-calorie low-protein
Description: In the low-calorie low-protein (Low) group, the calorie target will be 6 kcal/kg/day and the protein target 0.2-0.4 g/kg/d during the acute phase, i.e. from D0 to D7. On D8, the calorie target will be 30 kcal/kg/d and the protein target 1.2-2.0 g/kg/d.

Intervention type: PROCEDURE
Group type: ACTIVE_COMPARATOR
Intervention: standard-calorie/standard-protein
Description: In the standard-calorie/standard-protein (Standard) group, the first-line calorie target calculated based on body weight is 25 kcal/kg/day and the protein target 1.0-1.3 g/kg/d during the acute phase, i.e. from D0 to D7. On D8, the calorie target will be 30 kcal/kg/d and the protein target 1.2-2.0 g/kg/d.
Study: NCT04259385

Intervention type: BEHAVIORAL
Group type: EXPERIMENTAL
Intervention: Exposure to sugar-sweetened beverage warning labels
Description: Graphic images of the amount of sugar (randomly assigned teaspoons, packets, or cubes) and text warning labels

Intervention type: BEHAVIORAL
Group type: EXPERIMENTAL
Intervention: Exposure to sugar-sweetened beverage warning labels
Description: Graphic images of the amount of sugar (randomly assigned teaspoons, packets, or cubes) and text warning labels
Study: NCT02082860

Intervention type: GENETIC
Group type: EXPERIMENTAL
Intervention: rAAV2/5-PBGD vector dosage 1
Description: Intravenous injection of rAAV2/5-PBGD vector, single administration on Day 1.

Intervention type: GENETIC
Group type: EXPERIMENTAL
Intervention: rAAV2/5-PBGD vector dosage 2
Description: Intravenous injection of rAAV2/5-PBGD vector, single administration on Day 1.

Intervention type: GENETIC
Group type: EXPERIMENTAL
Intervention: rAAV2/5-PBGD vector dosage 3
Description: Intravenous injection of rAAV2/5-PBGD vector, single administration on Day 1.

Intervention type: GENETIC
Group type: EXPERIMENTAL
Intervention: rAAV2/5-PBGD vector dosage 4
Description: Intravenous injection of rAAV2/5-PBGD vector, single administration on Day 1.
Study: NCT04473391

Intervention type: DEVICE
Group type: EXPERIMENTAL
Intervention: Cycle-ergometer training assisted by FES for lower extremities
Description: The intervention consists of FES treatment sessions on a cycle ergometer for the lower extremities. Each subject received 24 sessions lasting 45 minutes each and a frequency of 3 sessions per week. The sessions will be applied by a physiotherapist with experience in electrotherapy. A 6-channel FES device (TrainFES, Biomedical Devices SpA, Chile) will be used, which consists of a stimulator unit of 95x50x30mm and 100g of weight coupled to the motorized cycle ergometer (MOTOmed Viva 2, Reck GmbH., Germany), a remote user interface consisting of an android application for the configuration of the stimulation via Bluetooth 3.1, and an inertial measurement unit positioned on the rotation axis of the cycle ergometer to detect the rotations and trigger the synchronized electrical stimulation according to the stimulation pattern pre-configured for the pedaling exercise
Study: NCT02370745

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: GLP-1
Description: GLP-1 effects on skeletal muscle glucose and amino acid metabolism and microvascular blood flow will be scrutinised under the specified insulin concentrations. It will also be used to test the effect of intravenous feed on insulin secretion.
Study: NCT01408563

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: Cord Blood
Description: 2 cord blood units IV
Study: NCT00560937

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Pregnenolone
Description: Pregnenolone 50 mg twice a day (BID) x 2 weeks, Pregnenolone 150 mg BID x 2 weeks, Pregnenolone 250 mg BID x 4 weeks

Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Placebo
Description: Placebo (similar to active comparator) 50 mg BID x 2 weeks, Placebo (similar to active comparator) 150 mg BID x 2 weeks, Placebo (similar to active comparator) 250 mg BID x 4 weeks