ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01483118
Conditions: Polycystic Ovary Syndrome
Keywords: PCOS Insulin resistance Cinnamon extract Irregular menstrual cycles Ovarian cysts
Sponsor: Rogerio A. Lobo
Start date: 2011-03-01; Completion date: 2014-04-01
Enrollment: 45 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary purpose of this follow-up study is to determine if cinnamon can restore menstrual cyclicity in Polycystic Ovary Syndrome (PCOS) subjects with oligomenorrhea. As a secondary purpose, the investigators intend to confirm the salutatory effect of cinnamon on insulin resistance in larger group of study subjects.

Polycystic ovary syndrome (PCOS) is a very common condition found in women of childbearing age. PCOS patients often have irregular periods, extra hair growth, or difficulty becoming pregnant. The syndrome can also be associated with more serious conditions such as heart disease, diabetes, or cancer of the uterus. Although no one knows the cause of the syndrome, scientific studies showed that having too much insulin can be one of the reasons. In fact, almost every overweight woman with PCOS has been found to have high insulin levels.

Recently studies using rats and mice have shown that a commonly used spice, cinnamon, may also reduce the body's insulin level. Another study showed that daily use of cinnamon for forty days lowered the blood sugar level in patients with diabetes. Our own study also showed that using cinnamon everyday for 8 weeks decreased insulin resistance in women with PCOS. The purpose of this study is to see if cinnamon can help women with PCOS have more regular periods.

Detailed description:
All patients will eat a balanced diet containing 1800 calories per day, but half of the patients in the study will take pre-made cinnamon extract pills three times a day, while the other half will take placebo pills (pills with no cinnamon extract) three times a day for 6 months. During this time, every patient will keep track of her period on a calendar.

Blood tests measuring insulin, substances important for insulin action, cholesterol, and glucose (sugar) will be taken before and after the 6 months of medication. A total of 8 separate visits will be needed to finish the study. At the end of the study, the investigators will then compare the number of periods, blood glucose, insulin, and cholesterol levels between the patients that took cinnamon and the patients that took placebo.

Arms: arm 1: PCOS patients receiving abstract of cinnamon arm 2: PCOS patients receiving placebo capsules
Interventions: intervention 1: Cinnamon Extract intervention 2: Placebo
Intervention descriptions: intervention 1: Purified aqueous abstract of cinnamon in 125mg capsules, which would be taken orally before each meal, for a total of 1,500mg/day for 6 months. intervention 2: Placebo capsules containing ground cereal.

Protocol documents:
Clinical trial NCT01549587
Conditions: Gingivitis Pregnancy
Sponsor: Procter and Gamble
Start date: 2012-02-01; Completion date: 2014-04-01
Enrollment: 746 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will track changes in oral health in pregnant women. Subjects will be assigned to either regular oral care or advanced oral care and be given oral care products to use until they deliver. A comparison between the two groups (regular and advanced oral care) will be made to see if the oral care products impacted oral health and maternity variables.

Detailed description:

Arms: arm 1: toothpaste, toothbrush and dental floss arm 2: toothpaste, toothbrush, mouth rinse and dental floss plus specialized education
Interventions: intervention 1: 0.243% sodium fluoride intervention 2: toothbrush intervention 3: dental floss intervention 4: 0.454% stannous fluoride intervention 5: toothbrush intervention 6: 0.07% Cetylpyridinium chloride intervention 7: dental floss
Intervention descriptions: intervention 1: dentifrice: brush thoroughly twice daily intervention 2: brush thoroughly twice daily intervention 3: floss the whole mouth once daily intervention 4: dentifrice: twice daily brush thoroughly for 2 minutes intervention 5: twice daily brush thoroughly for 2 minutes intervention 6: mouth rinse: rinse with 20 mL of mouth rinse for 30 seconds twice daily intervention 7: floss the whole mouth once daily

Protocol documents:
Prot_000.pdf: 







































SAP_001.pdf:
Clinical trial NCT01644175
Conditions: Hypercholesterolemia
Sponsor: Sanofi
Start date: 2012-07-01; Completion date: 2014-04-01
Enrollment: 316 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Alirocumab (SAR236553/REGN727) is a fully human monoclonal antibody that binds proprotein convertase subtilisin/kexin type 9 (PCSK9).

Primary Objective of the study:

* To demonstrate the reduction of low-density lipoprotein cholesterol (LDL-C) by alirocumab as add-on therapy to stable maximally tolerated daily statin therapy with or without other lipid-modifying therapy (LMT) in comparison with placebo after 24 weeks of treatment in high cardiovascular (CV) risk participants with hypercholesterolemia

Secondary Objectives:

* To evaluate the effect of alirocumab in comparison with placebo on LDL-C at other time points
* To evaluate the effect of alirocumab on other lipid parameters
* To evaluate the safety and tolerability of alirocumab

Detailed description:
The maximum study duration was 62 weeks per participant, including a 2-week screening period, 52-week randomized treatment period, and 8-week follow-up period.

Arms: arm 1: Placebo (for alirocumab) every 2 weeks (Q2W) added to stable Lipid-Modifying Therapy (LMT) for 52 weeks. arm 2: Alirocumab 75 mg Q2W added to stable LMT for 52 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) at Week 8.
Interventions: intervention 1: Placebo (for alirocumab) intervention 2: Alirocumab intervention 3: Lipid-Modifying Therapy (LMT)
Intervention descriptions: intervention 1: Solution for injection, one subcutaneous injection in the abdomen, thigh, or outer area of upper arm with a disposable auto-injector (also known as pre-filled pen). intervention 2: Solution for injection, one subcutaneous injection in the abdomen, thigh, or outer area of upper arm with a disposable auto-injector (also known as pre-filled pen). intervention 3: Statin (rosuvastatin, simvastatin or atorvastatin) at stable dose with or without other LMT as clinically indicated.

Protocol documents:
Clinical trial NCT02016625
Conditions: Healthy
Sponsor: Boehringer Ingelheim
Start date: 2013-12-01; Completion date: 2014-04-01
Enrollment: 32 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The primary objective of this trial is to investigate the effect of multiple-dose faldaprevir (FDV) on the single-dose pharmacokinetics of cyclosporine or tacrolimus

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Faldaprevir intervention 2: Faldaprevir intervention 3: Cyclosporine intervention 4: Tacrolimus
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None intervention 4: None

Protocol documents:
Clinical trial NCT00001304
Conditions: Hypoparathyroidism
Keywords: Hypoparathyroidism Parathyroid Hormone Vitamin D Calcium Metabolism PTH 1-34 Bone
Sponsor: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Start date: 1991-10-01; Completion date: 2014-04-01
Enrollment: 27 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study has been important in establishing synthetic human parathyroid hormone 1-34 (PTH) as a beneficial treatment for hypoparathyroidism, superior to conventional therapy with calcium and calcitriol. Providing synthetic human parathyroid hormone 1-34 (PTH) to patients who are unresponsive to conventional therapy has enabled severe cases of hypoparathyroidism to be managed effectively with the investigational drug, PTH. The primary goals of this study are to (1) provide long-term PTH therapy to patients who do not respond to conventional therapy; (2) understand the long-term effect of therapeutic PTH replacement on kidney function and bone mineral density; (3) study and track linear growth and bone accrual in children with hypoparathyroidism. (4) determine if subjects reach a normal level of peak bone mass and if the timing of this is comparable to normal age-matched healthy controls.

Detailed description:
Vitamin D and its analogs, the conventional treatment for hypoparathyroidism, are associated with chronic hypercalciuria due to their lack of calcium-retaining effect in the kidney. This side effect usually occurs even while maintaining the serum calcium in the normal range and may lead to calcium deposition in the kidney (nephrocalcinosis) and renal insufficiency. This study examines the long-term effects of subcutaneous parathyroid hormone (PTH) therapy on calcium metabolism, bone, and renal function. Our previous short-term pilot study comparing subcutaneous PTH with calcitriol demonstrated a significant decrease in urinary calcium excretion during PTH therapy. Based upon these results, we hypothesized that treatment with PTH is more physiologic and provides improved long-term metabolic control. Additionally, treatment with PTH may avoid the adverse side effects on the kidney that are associated with conventional therapy. Patients initially come to the Clinical Center for a two week inpatient evaluation. Subsequent follow-up will occur semiannually on an outpatient basis.

Arms: arm 1: All patients received twice daily synthetic Human Parathyroid Hormone 1-34. arm 2: All patients received twice daily Calcitriol and Calcium 1000mg divided into four doses daily.
Interventions: intervention 1: Synthetic Human Parathyroid Hormone 1-34 intervention 2: Calcitriol & Calcium
Intervention descriptions: intervention 1: twice daily subcutaneous injections intervention 2: Twice daily oral calcitriol with 1000 mg Calcium carbonate supplementation

Protocol documents:
Clinical trial NCT00094445
Conditions: Pancreatic Neoplasms Adenocarcinoma
Keywords: Pancreatic Cancer Adenocarcinoma of the pancreas Alternative therapy Pancreas Pancreatic Neoplasm Cancer of the pancreas
Sponsor: M.D. Anderson Cancer Center
Start date: 2004-11-01; Completion date: 2014-04-01
Enrollment: 50 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The goal of this clinical research study is to learn if treatment with curcumin can help shrink or slow the growth of pancreatic cancers. The effect of curcumin on the way pancreatic cancer cells function and the safety of treatment with curcumin will also be studied.

Detailed description:
Curcumin, a yellow substance extracted from the plant Curcuma longa, is commonly used as a food additive. It is a natural anti-inflammatory compound and has shown anti-tumor activity in the laboratory. During this study, you will receive much higher doses of curcumin than can be obtained from the diet.

During the study, you will receive curcumin by mouth every day. You will be required to take up to 16 pills per day each morning. Every 8-week period you take curcumin is considered a "course" of treatment. The number of courses you receive depends on how you are responding to treatment. You can continue treatment as long as the disease does not get worse. If the disease gets worse or you experience any intolerable side effects, you will be taken off the study and your doctor will discuss other treatment options with you.

You will be given a questionnaire to complete at the beginning of the study and once a week while you are on therapy to help the medical staff understand how the different symptoms from your disease are affecting you. This questionnaire, which should take about 5 minutes to complete, can be done over the telephone or with the help of one of the study staff during your visits.

At the end of each course of treatment (every 8 weeks), you will have a physical exam and the tumor will be re-evaluated using CT scans and/or blood (about 2 tablespoons) tests.

This is an investigational study. Curcumin is a commercially available substance, which is commonly used as a food additive. Up to 50 participants will take part in this study. All will be enrolled at M. D. Anderson.

Arms: arm 1: Oral curcumin daily for eight weeks, starting dose 8 gm per day.
Interventions: intervention 1: Curcumin
Intervention descriptions: intervention 1: Starting dose 8 gm orally per day for 8 weeks. If patient experiences grade III toxicity, dose held and restarted with a 50% dose reduction after resolution of toxicity to \</= Grade I. Patients with grade IV toxicity will discontinue treatments. Patients with \</= grade I toxicity may have a 25% dose increase at each four-week period. Patients will continue on treatment until disease progresses, unless Grade III toxicity supervenes.

Protocol documents:
Clinical trial NCT00104871
Conditions: Insular Thyroid Cancer Recurrent Thyroid Cancer Stage II Follicular Thyroid Cancer Stage II Papillary Thyroid Cancer Stage IV Follicular Thyroid Cancer Stage IV Papillary Thyroid Cancer
Keywords: National Thyroid Cancer Treatment Cooperative Study Group NTCTCSG bortezomib velcade metastatic differentiated thyroid carcinoma Differentiated thyroid carcinoma follicular epithelial thyroid cells papillary oxyphilic cell Hurthle cell insular cell columnar cell tall cell
Sponsor: National Cancer Institute (NCI)
Start date: 2004-12-01; Completion date: 2014-04-01
Enrollment: 24 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This phase II trial is studying how well bortezomib works in treating patients with metastatic thyroid cancer that did not respond to radioactive iodine therapy. Bortezomib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth

Detailed description:
PRIMARY OBJECTIVE:

I. Determine the efficacy of bortezomib, in terms of tumor response rate, in patients with metastatic papillary or follicular thyroid cancer unresponsive to prior radioiodine therapy.

SECONDARY OBJECTIVE:

I. Determine the clinical activity of this drug, in terms of progression-free survival, in patients treated with this drug.

OUTLINE: This is an open-label, multicenter study. Patients receive bortezomib IV over 3-5 seconds on days 1, 4, 8, and 11. Treatment repeats every 21 days for at least 4 courses in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed periodically.

Arms: arm 1: Bortezomib 1.3 mg/m\^2 intravenous (IV) at over 3-5 seconds on days 1, 4, 8, and 11. Treatment repeats every 21 days for at least 4 courses.
Interventions: intervention 1: Bortezomib
Intervention descriptions: intervention 1: Administered IV at the dose of 1.3 mg/m\^2 on a twice-weekly schedule for 2 consecutive weeks on days 1, 4, 8, and 11, followed by a 10 day rest period on days 12-21 (one cycle). In the absence of clinical progression, treatment continued for a minimum of 4 treatment cycles (or 12 weeks).

Protocol documents:
Clinical trial NCT00109928
Conditions: Lymphoma
Keywords: stage III adult diffuse mixed cell lymphoma stage IV adult diffuse mixed cell lymphoma contiguous stage II adult diffuse mixed cell lymphoma noncontiguous stage II adult diffuse mixed cell lymphoma contiguous stage II adult diffuse large cell lymphoma noncontiguous stage II adult diffuse large cell lymphoma stage III adult diffuse large cell lymphoma stage IV adult diffuse large cell lymphoma anaplastic large cell lymphoma
Sponsor: SWOG Cancer Research Network
Start date: 2005-09-01; Completion date: 2014-04-01
Enrollment: 34 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
RATIONALE: Drugs used in chemotherapy, such as cisplatin, etoposide, gemcitabine, and methylprednisolone, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more cancer cells.

PURPOSE: This phase II trial is studying how well combination chemotherapy works in treating patients with newly diagnosed stage II, stage III, or stage IV T-cell non-Hodgkin's lymphoma.

Detailed description:
OBJECTIVES:

Primary

* Determine 2-year overall survival of patients with newly diagnosed, bulky stage II or stage III or IV peripheral T-cell non-Hodgkin's lymphoma treated with cisplatin, etoposide, gemcitabine, and methylprednisolone.

Secondary

* Determine the toxicity of this regimen in these patients.
* Determine the response rate (complete unconfirmed response, complete response, and partial response) in patients treated with this regimen.
* Determine progression-free survival of patients treated with this regimen.

OUTLINE: This is a pilot, multicenter study.

Patients receive cisplatin IV over 30-60 minutes, etoposide IV over 30-60 minutes, and methylprednisolone IV over 5 minutes on days 1-4. Patients also receive gemcitabine IV over 30-60 minutes on day 1. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed at 3-6 weeks, 3 months, and then every 6 months for up to 3 years.

PROJECTED ACCRUAL: A total of 55 patients will be accrued for this study within 3 years.

Arms: arm 1: VP-16 (Etoposide) 40 mg/m2 IV Days 1-4 Methyl Prednisolone 250 mg IV Days 1-4 Cisplatin 25 mg/m2 IV Days 1-4 Gemcitabine 1,000 mg/m2 IV Day 1
Interventions: intervention 1: cisplatin intervention 2: etoposide intervention 3: gemcitabine intervention 4: methylprednisolone
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None intervention 4: None

Protocol documents:
Clinical trial NCT00153803
Conditions: Carcinoma, Non-Small-Cell Lung Non-small Cell Lung Cancer NSCLC
Keywords: Erlotinib Tarceva Web based Stage III NSCLC
Sponsor: Dartmouth-Hitchcock Medical Center
Start date: 2005-05-01; Completion date: 2014-04-01
Enrollment: 245 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a national, randomized, web-based, double-blind study to determine whether erlotinib (Tarceva) compared to placebo improves progression-free survival (PFS) for patients with inoperable, stage III NSCLC following concurrent docetaxel, carboplatin and thoracic radiotherapy. We hypothesize that the introduction of this orally active, well-tolerated agent following concurrent chemoradiation and prior to the emergence of drug resistance will prolong the progression-free survival by 40% (10 months → 14 months).

Detailed description:
The promising activity of erlotinib as a single agent in advanced refractory NSCLC along with its oral administration and favorable adverse event profile makes this agent an excellent candidate to incorporate into combined modality therapy in the early stages of lung cancer. Based on these data, erlotinib is an attractive novel approach to maintenance therapy in unresectable stage III NSCLC following completion of concomitant chemoradiation. Although, a subset of patients with unresectable stage III NSCLC will be long-term survivors following chemotherapy and thoracic radiation therapy, the vast majority relapse within the first year following therapy and eventually die from chemotherapy refractory disease. We hypothesize that the introduction of an potent tyrosine kinase inhibitor to the epidermal growth factor receptor following effective concomitant chemoradiotherapy with docetaxel and carboplatin will prolong the progression-free survival time for these patients.

Arms: arm 1: Erlotinib (Tarceva) 150mg: Erlotinib 150mg orally each day. Patients will be treated on a continuous, once daily oral dosing schedule until disease progression, withdrawal of consent, unacceptable adverse events, death or completion of 3 years of therapy. arm 2: Matched Placebo: Matched placebo orally each day. Patients will be treated on a continuous, once daily oral dosing schedule until disease progression, withdrawal of consent, unacceptable adverse events death or completion of 3 years of therapy.
Interventions: intervention 1: Erlotinib (tarceva) intervention 2: Placebo
Intervention descriptions: intervention 1: Erlotinib 150mg orally each day. Patients will be treated on a continuous, once daily oral dosing schedule until disease progression, withdrawal of consent, unacceptable adverse events, death or completion of 3 years of therapy. intervention 2: Matched placebo orally each day. Patients will be treated on a continuous, once daily oral dosing schedule until disease progression, withdrawal of consent, unacceptable adverse events death or completion of 3 years of therapy.

Protocol documents:
Clinical trial NCT00390611
Conditions: Ovarian Cancer
Keywords: Ovarian Cancer
Sponsor: SCRI Development Innovations, LLC
Start date: 2006-10-01; Completion date: 2014-04-01
Enrollment: 85 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This trial will compare the efficacy and toxicity of standard first-line chemotherapy alone vs. standard chemotherapy plus sorafenib in patients with stage III/IV ovarian cancer following cytoreductive surgery. Patients with residual large volume disease and/or bowel involvement will be excluded, to minimize the risk of bowel perforation.

Detailed description:
All patients must be at least 4 weeks from cytoreductive surgery before starting treatment. Patients will be randomized to receive treatment with either paclitaxel/carboplatin + sorafenib or paclitaxel/carboplatin. Paclitaxel/carboplatin will be repeated every 21 days for a maximum of 6 cycles. Patients with objective response/stable disease after completing 6 courses of chemotherapy will continue sorafenib until disease progression or for a total of 12 months.

\- Regimen A:

Paclitaxel 175 mg/m2 1-3 hour IV infusion, Day 1

Carboplatin AUC 6 infused over 20 minutes IV, Day 1

Sorafenib 400mg PO bid

\- Regimen B:

Paclitaxel 175mg/m2, 1-3 hour IV infusion, Day 1

Carboplatin AUC 6.0, 20 minute IV infusion, Day 1

Arms: arm 1: Paclitaxel 175 mg/m2 1-3 hour IV infusion, Day 1 Carboplatin AUC 6 infused over 20 minutes IV, Day 1 Sorafenib 400mg PO bid arm 2: Paclitaxel 175 mg/m2 1-3 hour IV infusion, Day 1 Carboplatin AUC 6 infused over 20 minutes IV
Interventions: intervention 1: Sorafenib intervention 2: Paclitaxel intervention 3: Carboplatin
Intervention descriptions: intervention 1: None intervention 2: Paclitaxel intervention 3: Carboplatin

Protocol documents: