cyrilzakka/clinical-trials huggingface dataset:
Fluorouracil, Cisplatin, and Radiation Therapy in Treating Patients With Stage II, Stage III, or Stage IV Nasopharyngeal Cancer

RATIONALE: Drugs used in chemotherapy, such as fluorouracil and cisplatin, work in different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining fluorouracil and cisplatin with radiation therapy may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving fluorouracil and cisplatin together with radiation therapy works in treating patients with stage II, stage III, or stage IV nasopharyngeal cancer.

OBJECTIVES:

Primary

* Determine progression-free survival of patients with previously untreated stage IIB-IVB nasopharyngeal cancer treated with fluorouracil, cisplatin, and radiotherapy.

Secondary

* Determine overall survival and response rate in patients treated with this regimen.
* Determine compliance to this regimen in these patients.
* Determine the toxicity of this regimen in these patients.

OUTLINE: This is a multicenter study.

Patients receive chemotherapy comprising fluorouracil IV continuously on days 1-5 and cisplatin IV continuously on days 6-7. Beginning 2-3 days after the completion of chemotherapy, patients undergo radiotherapy once daily, 5 days a week, for 4 weeks. With 2-3 days between each course, patients receive a second course of chemotherapy, undergo a second course of radiotherapy, and then receive a third course of chemotherapy. Treatment continues in the absence of unacceptable toxicity or disease progression.

Patients are followed for 3 years.

PROJECTED ACCRUAL: A total of 90 patients will be accrued for this study within 2 years.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Histologically confirmed nasopharyngeal cancer (NPC)

  * Type I-III disease by WHO classification
  * Stage IIB-IVB disease by TNM classification with no distant metastases by chest x-ray, liver ultrasonography or CT scan, and bone scintigraphy

    * Lymph node metastases evaluated by CT scan, MRI, and palpation
  * Progression range of primary lesion evaluated by MRI and pharyngeal fiberoptic endoscopy

PATIENT CHARACTERISTICS:

Age

* 18 to 70

Performance status

* ECOG 0-2

Life expectancy

* Not specified

Hematopoietic

* WBC \> 3,500/mm\^3
* Platelet count \> 100,000/mm\^3

Hepatic

* No severe hepatic dysfunction

Renal

* Creatinine clearance \> 60 mL/min
* No severe renal dysfunction

Cardiovascular

* No severe cardiac dysfunction

Pulmonary

* No severe pulmonary dysfunction

Other

* No other active cancer

PRIOR CONCURRENT THERAPY:

Biologic therapy

* No prior biologic therapy for NPC

Chemotherapy

* No prior systemic chemotherapy for NPC

Endocrine therapy

* Not specified

Radiotherapy

* Not specified

Surgery

* Not specified
Effectiveness of Bronchoscopic Interventions for Malignant Airway Obstruction

The goal of this clinical research study is learn about side effects and the success of bronchoscopies when performed in cancer patients with and without symptoms.

This is an investigational study.

Up to 110 patients will take part in this study. All will be enrolled at MD Anderson.

If participant agrees to take part in this study, researchers will collect information from participant's medical records.

Length of Study:

Researchers will continue to collect participant's medical information for up to 2 years.

Additional Information:

Participant's data will be kept in a database on a password-protected computer in a secure office. This information will only be available to the study doctors and staff.

Eligibility Criteria:
Inclusion Criteria:

° All patients undergoing interventional bronchoscopy during the first 12 months will be enrolled, with follow-up occurring out to 2 years from the study startup (the duration of the grant).

Exclusion Criteria:

* Age less than 18 years,
* Inability to participate in telephone follow-up
Risk Factors for Coronary Artery Calcification and Left Ventricular Hypertrophy in Hemodialysis Patients

Individuals with kidney disease are at a higher risk for heart and vascular diseases, including heart attacks and strokes, than those with normal kidney function. The purpose of this research study is to collect information on the causes, complications and treatment of kidney disease. Patient characteristics, comorbid diseases and laboratory markers used in routine practice, as well as novel biochemical markers and genetic data will be collected to examine relationships between biochemical and genetic markers and cardiovascular risk. Information on the health history of incident hemodialysis and peritoneal dialysis patients will be captured using structured patient interviews and review of medical records. Blood and urine specimens will be collected at the time of dialysis initiation and stored in order to perform novel biochemical and genetic assays in the future. The overall goal of the CKDCS/LUCID study is improve understanding of cardiac-associated risks and to improve treatment in patients with kidney disease. A cardiac imaging substudy will be performed in a subset of patients enrolled. The goals of the substudy are to examine whether the risks of developing common cardiac-related complications (coronary artery calcification \[CAC\] and left ventricular hypertrophy \[LVH\]) are associated with certain medications taken by individuals on dialysis and whether these risks are modified by a genotypic predisposition.

This study is being conducted under the Sponsorship of the University of Alberta (Edmonton, Alberta, Canada) and is funded by Canadian Institutes of Health Industry Partnered Research Grant IRO 90262 - with partnership funding from Abbott Laboratories. The co-Principal Investigators are Marcello Tonelli MD SM and Ravi Thadhani, MD, MPH . A total of 750 patients are anticipated being enrolled at Massachusetts General Hospital (MGH). The remaining patients are being enrolled in Canada.

This study will utilize data from "The Canadian Kidney Disease Cohort Study" (CKDCS) and "The Longitudinal US/Canada Incident Dialysis STUDY (LUCID).

Eligibility Criteria:
Inclusion Criteria:

* Adults (≥ 18 years of age) commencing hemodialysis or peritoneal dialysis.

Exclusion Criteria:

• Unable to provide informed consent.

Exclusion Criteria for the cardiac substudy:

CT exclusion criteria

1. Pregnancy
2. Obesity (\>275 lbs)
3. Rapid atrial fibrillation, bigeminy or trigeminy
4. Any condition that impedes the ability to lie flat during the CT (eg:decompensated congestive heart failure).

MRI exclusion criteria

1. Cardiac pacemaker or implantable defibrillator
2. Obesity (\>275lbs)
3. Intraocular metal
4. Cerebral aneurysm clips, programmable shunt, etc.
5. Any type of ear implant
6. Any implanted device (eg: insulin, drug infusion device)
7. Metal shrapnel or bullet
8. Any condition that impedes the ability to lie flat during the MRI (eg:decompensated congestive heart failure)
A Long Term Follow up of Anterior Meshes for Recurrent Prolapse

Prolapse of the vaginal wall and uterus are common conditions affecting up to 50% of parous women. The socioeconomic, psychological and physical impacts of prolapse are considerable. 11% of women will undergo a surgical repair by the age of 80 years. The commonest compartment affected is the anterior vaginal wall. Unfortunately there is a significant rate of recurrent prolapse or a failure of the primary procedure. This has lead to the introduction of new techniques and the use of different materials to augment the repair. Mesh augmented repairs aim to reduce the rate of recurrent prolapse. However, the use of synthetic mesh is associated with complications which are not found in non mesh repairs. 10% of women will have a mesh complication of which 70% will require a further surgical procedure to manage the complication. There are extra costs associated with purchasing the mesh, with longer operating times to insert the mesh and managing complications caused by the mesh. Balancing the extra risks of mesh surgery against the benefits is probably one of the most contentious issues in urogynaecology at the present time.

Regulatory authorities in the USA (FDA) and UK (MHRA) have become increasingly interested in the use of mesh to support the vaginal wall in prolapse surgery due to risks and complications being reported. To date there is little evidence regarding the long term safety and efficacy of anterior mesh repairs. This study aims to rectify this deficiency for Perigee.

This will be a consecutive cohort study of patients identified from a surgical database of Perigees performed in a single centre. All patients will have had the procedure performed between 2007 and 2011. This will be a single centre study. The principle investigator has both electronic and hand written records of all Perigee repairs performed since the introduction of this technique in 2007. The patients will be identified from both the paper and electronic databases and cross referenced.

After obtained appropriate ethical approval, patients identified as having a perigee mesh inserted will be asked to attend Medway Hospital for a full clinical evaluation. They will be sent a letter with an appointment to come to the hospital. They will be asked to complete the Pelvic floor distress inventory questionnaire to assess their symptoms. They will have a pelvic examination to determine if they have any mesh erosion and will undergo a POP-Q score. This visit will take 1 hour.

Eligibility Criteria:
Inclusion Criteria:

* Women undergoing a perigee procedure after January 2007

Exclusion Criteria:

* Patient having non mesh repairs over the same time scale
Evaluation of Safety of Filler Injection in Subcutaneous Tissues

Adipearl is an injectable filler intended to be injected subcutaneously.


Eligibility Criteria:
Inclusion Criteria:

* Subject having given freely and expressly informed consent;
* Subject deemed by the Investigator to be medically fit for injection of the product;
* Female or male subjects aged 22 to 65 years (inclusive);

Exclusion Criteria:

* Pregnant or nursing woman or planning a pregnancy during the study.
* Subject who had been deprived of their freedom by administrative or legal decision or who is under guardianship.
* Subject participating to another research study.
* Subject with the presence of any condition, which in the opinion of the Principal Investigator, that makes her/him unable to complete the study per protocol.
Efficacy and Safety of Intranasal Morphine for Pain After Elective Orthopedic Surgery

Multiple-center, multiple-dose, randomized, double-blind, six-arm, active- and placebo-controlled study in patients with moderate to severe post-surgical pain from elective orthopedic surgery with safety observed for a total of 30 hours post first dose.

Multiple-center, multiple-dose, randomized, double-blind, six-arm, active- and placebo-controlled study of repeated intermittent PRN dosing for 24 hours of Intranasal (IN) Morphine Nasal Spray (MNS075) 7.5 mg and 15 mg, 7.5 mg IV morphine infusions and placebo (either IN or IV), in patients with moderate to severe post-surgical pain from elective orthopedic surgery with safety observed for a total of 30 hours post first dose.

Eligibility Criteria:
Inclusion Criteria:

* Over 18 years old
* Scheduled (within two weeks of the screening visit) to undergo elective orthopedic surgery (e.g., bunionectomy, arthroscopic knee surgery, rotator cuff repair)
* Moderate to severe pain within 8 hours following completion of the required surgery

Exclusion Criteria:

* Previous anaphylactic or serious allergic reaction to shellfish or opioids
* History of sleep apnea

Other Inclusion/Exclusion Criteria May Apply
Three Dimension Laparoscopic Versus Open Surgery for Gallbladder Carcinoma

Introduction: Surgery is the only potential curative approach for the highly lethal gallbladder carcinoma. The laparoscopic surgery has developed rapidly since invented. As a kind of minimally invasive surgery, laparoscopic cholecystectomy including segmentg IVB and V is preferred by most of surgeons. There have been studies comparing intraoperative blood loss, postoperative morbidity, length of hospital stay and costs of laparoscopic cholecystectomy over open surgery. However, randomized controlled trials are still lacking but clearly required to reveal whether the laparoscopic approach or the open surgery is the better option for treating gallbladder carcinoma. We hypothesize that incidence of postoperative complications is lower, and time to functional recovery is shorter after laparosopic compared with open approach, even in an enhanced recovery setting.

Methods/design: We designed this prospective, randomized, controlled trial with two treatment approaches, laparoscopic versus open surgery for gallbladder carcinoma. The trial hypothesis is that laparoscopic approach has advantages in postoperative recoveries and be equivalent in operation time, oncological results and long-term follow-up compared with open counterpart. The duration of the entire trial is four years including prearrangement, follow-up and analyses.

Discussion: Although several studies have discussed different surgical approaches for gallbladder carcinoma treatment, this trial will be a thorough RCT comparing laparoscopic and open surgery for gallbladder carcinoma.


Eligibility Criteria:
Inclusion Criteria:

1. Histologically proven gallbladder carcinoma.
2. Highly presumed malignancy with difficulties to obtain histological evidence.
3. Preoperative staging work up performed by upper abdomen enhanced CT scan and showed no vessel involvment.
4. The subject understands the nature of this trial and willing to comply.
5. Ability to provide written informed consent.
6. Patients treated with curative intent in accordance to international guidelines.

Exclusion Criteria:

1. Distant metastases: peritoneal carcinomatosis, liver metastases, distant lymph node metastases, involvement of other organs.
2. Patients with high operative risk as defined by the American Society of Anesthesiologists (ASA) score \>4.
3. Synchronous malignancy in other organs.
4. Palliative surgery.
Trial of Excision Versus Photodynamic Therapy in the Treatment of Bowen's Disease

The purpose of this study is to identify the most optimal therapy for Bowen's disease: excision versus Photodynamic therapy.

The study is a randomized clinical trial in which two treatment options for Bowen's disease, excision and photodynamic therapy, are compared on recurrence rate, cosmesis en expenses.

Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years
* Histological proven Bowen's disease on scalp, face, trunk, arms and legs
* Informed Consent

Exclusion Criteria:

* Recurrent Bowen's disease
* Anogenital or subungual Bowe's disease
* Other skin malignancy in the same area
* Porphyria
Phase I Study of BAY73-4506 in Chinese Patients With Advanced, Refractory Solid Tumors

This will be an uncontrolled, open-label, non-randomized, phase I study. The primary objectives of this study are to define the pharmacokinetics (PK) and to evaluate the safety and tolerability of Regorafenib administered orally as a single agent in Chinese patients with advanced solid tumors. The secondary objectives are to evaluate tumor response of patients treated with Regorafenib.


Eligibility Criteria:
Inclusion Criteria:

* Male or female Chinese subjects \>/- 18 years
* Advanced, histologically or cytologically confirmed solid tumors
* Subjects malignancies must be refractory to standard treatment or have no standard therapy available, or the subject actively refused any treatment that would be regarded standard, and/or if, in the judgment of the investigator or his/her designated associate(s), experimental treatment is clinically and ethically acceptable.
* Eastern Cooperative Oncology Group performance status (ECOG-PS) 0-1;
* Adequate bone marrow, liver and renal function
* Life expectancy of at least 3 months

Exclusion Criteria:

* Unstable/uncontrolled cardiac disease
* History of arterial or venous thrombotic or embolic events
* Malabsorption condition
* Severe renal impairment; persistent proteinuria \>/= Grade 3
* Symptomatic metastatic brain or meningeal tumors
* Clinically significant bleeding \>/=Grade 3 within 30 days before start of study medication.
Early Weight Bearing for Ankle Fractures

The purpose of this observational study is to assess the rate of return to work, rate of return to activities, functional outcome measures and pain scores in operatively repaired rotational Bimalleolar and Trimalleolar (AO/OTA Classification of 44A and 44B) ankle fractures not requiring fixation of the syndesmosis and allowed early weight bearing on or before the first post-operative visit.


Eligibility Criteria:
Inclusion Criteria:

* Men and women ages of 18 and up
* Closed, low-energy Bimalleolar and Trimalleolar rotational ankle fractures
* Orthopaedic Trauma Association (OTA) classification of 44A and 44B
* English speaking
* Able and willing to consent

Exclusion Criteria:

* Open fractures
* OTA classification of 43 and 44C
* Patients with diabetes mellitus
* No other lower extremity injuries that would affect functional outcomes
* Previous use of walking aides
* Patients with paralysis or hemiplegia
* Ankle fractures requiring syndesmotic repair
* Ankle fractures requiring fixation of the posterior malleolar
* Associated neurovascular injury
* Problems maintaining follow up (homeless or not willing to return for follow up)
* Pathological fractures
* Prisoners
* Patients not allowed to bear weight before the 6 week post-operative follow up visit
An Individualized-health eLibrary App for People With Multiple Sclerosis

The purpose of this study is to assess the effectiveness after using a new individualized-health e-library app named SavvyHealth among people with multiple sclerosis.

Participants will use our developed app for 21 days and take a before-use survey and a post-use survey.

Eligibility Criteria:
Inclusion Criteria:

* diagnosed with MS;
* 18 years or older;
* one comorbidity evaluated by a validated comorbidity questionnaire for people with MS;
* willing to take a survey;
* willing to use the app for 21 days;
* willing to be assigned to either the intervention or control group.

Exclusion Criteria:

-
Testing the Cognitive Facilitation Effect by Dietary Supplementation of MelaGene+ Drink

To assess the efficacy of MelaGene+ on cognitive performance


Eligibility Criteria:
Inclusion Criteria:

* 20 to 65-year-old males or females

Exclusion Criteria:

* Participants are breastfeeding, pregnant or planning to become pregnant during the test (self-report)
* Participants with heart, liver, kidney, endocrine and other major organic diseases (self-reported)
* Participants take drugs for a long time (self-report)
* Participants with mental illness or have undergone brain surgery
* Participants still can not clearly see words with 12pt on computer after corrected vision
Wellbutrin XL, Major Depressive Disorder and Breast Cancer

* To evaluate the efficacy of bupropion extended release (Wellbutrin XL™) in the treatment of Major Depressive Disorder in women with breast cancer.
* To evaluate the tolerability of bupropion extended-release (Wellbutrin XL™) in these patients

This is research study for women diagnosed with breast cancer and major depression. Women with breast cancer who are depressed may report greater pain, poorer quality of life and worse overall functioning than those without depression. The study will determine whether or not bupropion extended release (Wellbutrin XLTM) is useful in lessening the symptoms of depression in women with breast cancer. One reason for conducting this research with bupropion extended release (Wellbutrin XLTM) instead of another antidepressant is because bupropion has a lower likelihood of causing the side effects of weight gain, sexual dysfunction, and fatigue, which may be important for women with breast cancer and may even have a beneficial effect on these symptoms.

Bupropion extended release (Wellbutrin XL™)is approved by the United States Food and Drug Administration (FDA) for the treatment of major depression.

Eligibility Criteria:
Inclusion Criteria:

* Women aged 18 years or older
* Diagnosis of breast cancer, confirmed by histopathology; Stages 0, I, II, IIIA, or IIIB
* Clinical diagnosis of Major Depressive Disorder (DSM-IV-TR)
* Hospital Anxiety and Depression Scale (Zigmond and Snaith, 1983) depression subscale score of 11 or greater
* Montgomery Asberg Depression Rating Scale (MADRS; Montgomery and Asberg, 1979) score of 25 or greater at Screening and Baseline visits
* Use of antidepressants in a previous episode of major depression or in the past for any other indication does not affect the patient's inclusion in this study.
* During the current episode of major depressive disorder, as stated in the Exclusion criteria, failure to respond to one or more adequate trials of an antidepressant will exclude the patient from the study since this is not a study of "treatment-resistant depression".
* During the study, the patient may not use any other antidepressants.

Exclusion Criteria:

* Presence of another current clinically significant Axis I disorder like bipolar disorder, schizophrenia, or panic disorder
* Current (in past 6 months) comorbid active substance abuse or dependence
* Failure to respond to one or more adequate trials of an antidepressant in the current episode of MDD
* A reduction in MADRS score of 20% or greater from Screening to Baseline visit
* Clinically significant laboratory abnormalities that in the judgment of the Investigator would increase risk of adverse effects with bupropion
* Pregnant or lactating women
* History of an eating disorder, seizures, head injury, or other intracranial pathology because these conditions are usually contraindications to the use of bupropion XL
* Previous allergy or intolerance to bupropion
* Patients judged to be at significant suicidal risk
A Study to Evaluate THB001 in Adult Patients With Chronic Cold Urticaria

This is a phase 1b, open label, non-randomized, sequential dose-escalation, multicenter trial in adult patients with chronic cold urticaria.


Eligibility Criteria:
Key Inclusion Criteria:

1. Women and Men ages 18-75
2. Diagnosed with chronic, cold inducible urticaria for at least 3 months prior to starting the study and refractory to antihistamine treatment
3. Positive cold stimulation test assessed by TempTest® at the Screening and Baseline visits
4. Considered healthy as assessed by medical evaluation including review of medical history, physical examination, vital signs, laboratory tests and ECG recording
5. Willing and able to participate in all visits, undergo all study procedures and adhere to study restrictions

Key Exclusion Criteria:

1. A diagnosis of acute urticaria or non-cold chronic inducible urticaria
2. Ongoing treatment with immunosuppressant drugs (corticosteroids, cyclosporine, azathioprine, methotrexate, omalizumab, dupilumab, sulfasala-zine, dapsone or others)
3. A positive test for pregnancy, HIV, Hepatitis B or Hepatitis C
4. Clinical laboratory values outside of the normal ranges at the Screening visit
5. History of any clinically significant abnormality that would contraindicate participation

There are additional criteria that your study doctor will review with you to confirm you are eligible for the study.