cyrilzakka/clinical-trials huggingface dataset:
Docetaxel/Cisplatin/5-Fluorouracil (TPF) Human Papillomavirus (HPV) Squamous Cell Carcinoma Study

In this research study, the investigators are studying whether a reduced dose of radiation when given with standard doses of chemotherapy can reduce side effects without compromising control of the cancer. An approved treatment for squamous cell carcinoma of the head and neck is initial chemotherapy followed by radiation and chemotherapy together. This treatment is effective but has many immediate and long-term side effects. People who have squamous cell carcinoma of the head and neck (SSCHN) that is related to an infection by the human papillomavirus (HPV) have been shown to have a high response to this treatment along with a high cure rate. The investigators think that by reducing the intensity of this treatment, they may be able to reduce immediate and long-term side effects which may lead to long term improvements in quality of life and function.

OBJECTIVES:

Primary

To determine rate of local-regional control at 2 years

Secondary

To determine Progression Free Survival at 2 and 5 years

To determine Overall Survival at 2 and 5 years

To assess acute toxicity and long term toxicity of reduced radiation dose at 2 and 5 years

Eligibility Criteria:
Inclusion Criteria

* Histologically or cytologically confirmed squamous cell carcinoma of the oropharynx or unknown primary that is HPV 16 positive as determined by ISH and p16 positive as determined by IHC.
* Stage 3 or 4 disease without evidence of distant metastases
* At least one evaluable or uni- or bi-dimensionally measurable lesion by RECIST 1.1 criteria
* 18 years of age or older
* No previous surgery, radiation therapy or chemotherapy for SSCHN is allowed at time of study entry
* ECOG Performance Status of 0 or 1
* No active alcohol addiction
* Adequate bone marrow, hepatic and renal function as defined in the protocol
* Women of child-bearing potential must have a negative pregnancy test within 7 days of starting treatment

Exclusion Criteria

* Pregnant or breast feeding women or women and men of childbearing potential not willing to use adequate contraception while on treatment and for at least 3 months after
* Previous or current malignancies at other sites
* Symptomatic peripheral neuropathy of grade 2 or greater
* Symptomatic altered hearing greater than grade 2
* Other serious illnesses or medical conditions
* Patients that have experienced an involuntary weight loss of more than 25% of their body weight in the 2 months preceding study entry
* Concurrent treatment with any other anticancer therapy
* Participation in an investigational trial within 30 days of study entry
Whole-Body Cryotherapy (WBC) as an Adjunct Treatment on Pain in Fibromyalgia Persons: Short Time Effect.

Our aim was to determine whether Whole Body Cryotherapy (WBC) can result in improved pain status, perceived health, and quality of life in patients with fibromyalgia. It is hypothesized that this positive effect can be achieved through increased functional mobility and decreased pain intensity resulting from cold-induced modulation of the inflammation-immune axis.

24 patients with fibromyalgia were randomized into 2 groups (n=11 in the WBC group, n=13 in the control group). In the WBC group, 10 sessions of WBC were performed (in addition to usual care) in a standard cryotherapy room over a duration of 8 days. Patients in the control group did not change anything in their everyday activities. Several self-reported variables relating to perceived health were measured repeatedly (pain intensity, functional mobility, and quality of life).

Eligibility Criteria:
Inclusion Criteria:

Fibromyalgia diagnosis

Exclusion Criteria:

cardiorespiratory disorder current pregnancy cold intolerance Embolic diseases
Effects of Neo40(TM) With Caffeine on Cycling Time Trial Performance

Acute supplementation of Neo40(TM), a nitrate lozenge, will improve cycling performance


Eligibility Criteria:
Inclusion Criteria:

* Regular commuter cyclist or spin class participant
* Male (VO2max \< 50) or Female (VO2max \< 45)
* Healthy
* Blood pressure below 140/90
* Non-smoker

Exclusion Criteria:

* Does not cycle 2-3 times/week
* Regular consumption of performance-enhancing substances
* Type I or Type II diabetes
* Renal, hepatic or cardiac disease
* Current infectious disease
BetaPlus Survey - Observational Study to Assess Drug Adherence in Patients With Multiple Sclerosis After Conversion to Betaferon® by Using Elements of the BetaPlus Program

This is an observational survey to assess the factors that influence adherence to Betaferon therapy in multiple sclerosis patients using elements of the BetaPlus support program, including the nurse support and auto-injectors. The patients were evaluated under normal clinical practice and were asked to fill out the quality of life FAMS questionnaire, Coping processes (WCQ - Ways of Coping Questionnaire) and depression questionnaire CES-D.


Eligibility Criteria:
Inclusion Criteria:

* Relapsing-remitting MS (RRMS) or secondary-progressive MS (SPMS)
* Previous treatment with disease modifying drugs
* Adjustment of disease modifying treatment necessary at the discretion of the investigator
* Switch to Betaferon at least 1 month but not longer than 3 months prior to inclusion

Exclusion Criteria:

* Patients not fulfilling the indications in the local prescribing information
* Refusal to sign inform consent
Exercise for Stable Myasthenia Gravis

Generalized fatigue in myasthenia gravis results in physical deconditioning that reduces fitness and increases risk of obesity, hypertension, elevated cholesterol and type 2 diabetes. This study will examine how active and fit are 30 individuals with chronic, generalized myasthenic subjects. This study will also determine whether a 3 month home exercise program with aerobic, resistive, and pulmonary training can improve physical activity, strength, fitness, lung function and reduce cardiovascular disease risk.

Generalized fatigue in myasthenia gravis results in a sedentary lifestyle and profound physical deconditioning, leading to reduced fitness and increased risk of obesity, hypertension, dyslipidemia, and type 2 diabetes. This study will characterize the activity and fitness levels and cardiovascular disease risk profile in 30 chronic, generalized myasthenic subjects. Hypotheses are that a) subjects with myasthenia gravis are physically inactive with reduced fitness level and high incidence of obesity and poor cardiovascular disease risk profile, and b) a 3 month multi-modal home exercise program that includes aerobic, resistive, and pulmonary training components will improve physical activity, strength, fitness, dyspnea, body composition and reduce cardiovascular disease risk. Specific aims are to a) define the baseline physical activity and fitness levels and prevalence of insulin resistance and dyslipidemia in stable sedentary myasthenic subjects, b) determine whether a 3 month moderate intensity home exercise program is safe and feasible in deconditioned, stable myasthenic subjects and c) whether a 3 month comprehensive home exercise program can enhance fitness, strength, and lung function to improve physical activity and reduce cardiovascular disease risk.

Eligibility Criteria:
Inclusion Criteria:

* stable generalized myasthenia gravis
* adults age 18-70

Exclusion Criteria:

* already performing regular exercise
* unstable angina
* recent (\<3 month) myocardial infarction, stroke, hospitalization for major illness or major surgery
* chronic pain or orthopedic condition restricting exercise
* active cancer, excluding basal cell cancer
* anemia (HCT \<30)
* pregnancy
* myasthenia gravis exacerbation in past 3 months
Prostate Cancer - Comparative Outcomes of New Conceptual Paradigms for Treatment

This study will use a population-based cohort design to study men with newly diagnosed low- and intermediate-risk prostate cancer at high-volume centers in Southern California (SCa) and New York State (NYS). Complications of contemporary treatments for prostate cancer and quality of life outcomes, such as general health, urinary, sexual, and bowel function, cancer anxiety, and treatment regret will be compared and tracked over the course of this study.

Prostate cancer remains the most commonly diagnosed, solid organ tumor and the second most common cause of cancer death in U.S. men. Technological advances have enabled new treatment options, such as stereotactic body radiation therapy (SBRT) and partial gland ablation (PGA). Although heavily marketed as more convenient with fewer side effects, there is an absence of high-level, comparative effective research (CER) to discern relative outcomes to traditional therapies such as active surveillance (AS), radical prostatectomy (RP) and intensity modulated radiation therapy (IMRT).

Investigators hypothesize that PGA will be associated with less reduction of urinary and sexual function compared to before treatment than both RP and IMRT. SBRT is hypothesized to be associated with less reduction of urinary and sexual function before treatment compared to RP and IMRT. SBRT is hypothesized to be associated with less reduction in bowel function compared to IMRT. PGA hypothesized to be associated with better overall quality of life at 12 months compared to AS. Investigators hypothesize PGA and SBRT will be associated with fewer adverse events compared to RP and IMRT.

The investigators will conduct a pragmatic, population-based cohort study of men with newly diagnosed low and intermediate risk prostate cancer in Southern California (SCa) and New York State (NYS) Surveillance Epidemiology and End Results (SEER) regions to bridge the evidence gap concerning adverse events and patient reported outcomes. This study will inform multiple stakeholders, who contributed to the study design. Stakeholders include prostate cancer survivors, payers, medical device manufacturers, professional organizations, community and academic prostate cancer experts and the Food and Drug Administration (FDA).

Eligibility Criteria:
Inclusion Criteria:

* Pathologically-confirmed clinically localized prostate adenocarcinoma with National Comprehensive Cancer Network (NCCN) low (T1-T2a, Gleason 6, Grade Group 1, PSA \<10 ng/mL) or intermediate risk (T2b-T2c or, Gleason 7, Grade Group 2 or 3 or PSA 10-20 ng/mL)72 at one of the selected hospitals in SCa and NYS
* Diagnosis date during the 18 month recruitment window
* Able to read/speak English or Spanish
* Agree to participate by completing the baseline questionnaire

Exclusion Criteria:

* Clinically metastatic disease or high-risk PCa (T3a-T4, Gleason Grade Group 4 or 5 or PSA \>20 ng/mL
* Unable to read/speak English or Spanish
* Unwilling or unable to give informed consent.
A Suspected Association Between Sarcoidosis and Development of Diabetes Mellitus

The purpose of the study is to determine the characteristics of patients with diabetes and sarcoidosis and to compare them with those of patients with diabetes and no sarcoidosis. The investigators will approach these aims by measuring hemoglobin A1c, C peptide, insulin levels, and 2-hour glucose tolerance test results on the study population as well as collecting clinical data from records. Three groups of patients will be identified from pulmonary and endocrinology clinics at the University of Alabama at Birmingham. The first group will have a diagnosis of sarcoidosis without diabetes, the second group will have a diagnosis of both sarcoidosis and diabetes, and the third group will have a diagnosis of diabetes without sarcoidosis. Sample size is not pre-determined, but investigators anticipate this number to be less than 100. These patients will be asked in person during an office visit to join the study. For each patient who agrees to join, at a clinic visit, investigators will review and sign consent. Following the visit or at a time convenient for each patient, study subjects will undergo a fasting plasma venous sample collection for a hemoglobin A1c, C peptide, insulin level and perform a 2-hour oral glucose tolerance test. The degree of glucose intolerance and prevalence of diabetes will be analyzed and compared between the groups and to historical published control data via T test comparisons. At a later separate visit, patients recruited will undergo ultrasound of the pancreas to assess pancreatic size and morphology.


Eligibility Criteria:
Inclusion Criteria:

* Any adult patient referred to or followed in UAB pulmonary clinic with an established diagnosis of sarcoidosis. Any adult patient followed in UAB endocrinology clinic with a diagnosis of diabetes mellitus (excluding type 1 diabetes).

Exclusion Criteria:

* Type 1 diabetes and/or chronic use of corticosteroids.
Evaluation System and Clinical Application for Diabetic Retinopathy

Diabetic retinopathy(DR) is one of the most common and serious microvascular complications of diabetes,which is the primary cause of vision loss of diabetic patients. The risk of blindness is 25 times that of healthy people.Fundus fluorescein angiography (FFA) is the gold standard for diagnosing the stage of diabetic retinopathy.However,FFA is an invasive examination which requires the patient to be in good physical condition and is not suitable for large-scale screening.Therefore, it is important to build up an evaluation system for early diagnosis of DR,which is more convenient, safer, and non-invasive.Firstly, this study will retrospectively analyze the FFA images of DR to find the earliest and most frequently occurring fundus quadrant.Secondly,based on the retrospective analysis results, a prospective comparative study will be conducted,which combines the fundus photography with optical coherence tomography angiography(angio-OCT) and physical indicators to find out whether it has consistency, sensitivity and specificity with FFA in diagnosing the stage of DR in order to build up a more effective,safer and faster evaluation system and clinical application for DR.

Firstly, this study will retrospectively analyze the FFA images of DR to find the earliest and most frequently occurring fundus quadrant.Secondly,based on the retrospective analysis results, a prospective comparative study will be conducted,which combines the fundus photography with angio-OCT and physical indicators to find out whether it has consistency, sensitivity and specificity with FFA in diagnosing the stage of DR.Finally，based on all the results,to build up a more effective,safer and faster evaluation system and clinical application for DR.

Eligibility Criteria:
Inclusion Criteria:

Patients with diabetic retinopathy

Exclusion Criteria:

Refractive interstitial turbidity Cannot cooperate with examiner Retinal surgery in patients Malignant tumors Hematological diseases Immune diseases Glaucoma or other retinal diseases
Long-term Safety and Tolerability of Atacicept (Long-term Follow-Up of Participant Who Participated in ADDRESS II)

This is a multicenter, double-blind, Phase 2b, long-term extension (LTE) to the ADDRESS II core trial (EMR 700461-023) (NCT01972568), to evaluate long-term safety and tolerability of atacicept in participants with systemic lupus erythematosus (SLE). Participants who completed the 24-week core study ADDRESS II core study (NCT01972568) and thus not met any of the discontinuation criteria were invited to enter this long-term extension (LTE) study NCT02070978.


Eligibility Criteria:
Inclusion Criteria:

* Participants who had completed the 24-week treatment period of study EMR-700461-023 (ADDRESS II core trial)
* Women of childbearing potential who had a negative pregnancy test
* Other protocol defined inclusion criteria were applied

Exclusion Criteria:

* Active neurological symptoms of SLE that were deemed severe or progressive
* Diagnosis of any demyelinating disease, such as, but not restricted to, multiple sclerosis (MS) or optic neuritis
* Pregnancy
* Active clinically significant viral, bacterial, or fungal infection, or any major episode of infection that in the investigator's opinion makes the participants unsuitable to continued participation in the study
* Other protocol defined exclusion criteria were applied
Therapeutic Effects of Silymarin in Patients With B-thalassemia Major

Silymarin, a flavonolignan complex isolated from Silybum marianum, has a strong antioxidant, hepatoprotective and iron chelating activities. The present study has been designed to investigate the therapeutic activity of orally administered silymarin in patients with thalassemia major under conventional iron chelation therapy. A 6-month randomized, double-blind, clinical trial was conducted in 140 beta-thalassemia major patients in two well-matched groups. Patients are randomized to receive a silymarin tablet (140 mg) three times a day plus conventional desferrioxamine therapy or the same therapy but a placebo tablet instead of silymarin. Clinical laboratory tests of iron status and liver function are assessed at the beginning and the end of the trial.


Eligibility Criteria:
Inclusion Criteria:

* Presence of major Beta-thalassemia
* Age 12 years or older
* Iron overload condition (serum ferritin levels between 1000-5000 ng/mL) Regular desferrioxamine administration (50 mg/kg)
* Continuous blood transfusions
* Negative CRP test

Exclusion criteria:

* Hepatitis B or C infection
* Positive HIV test
* Chronic renal or heart failure
* Iron chelating therapy with other iron chelators
Post Operative Analgesia and Patient Satisfaction

To understand how patients perceive the quality of care they receive when given different post-operative analgesic medications. Specifically the investigators want to assess whether patients who receive non-opioid analgesia following surgery endorse appropriate quality and satisfaction with their care compared to those who receive opioid medication.

It is routine practice to give analgesic medication after any surgical procedure to provide adequate pain control for patients. However with the increase in abuse of opioid prescription medications, physicians have given a new emphasis to different pain regimens that aim to limit the use of opioid medications. The investigator's previous clinical trial demonstrated that for patients undergoing outpatient otolaryngology procedures, not only does Ibuprofen provide equally effective analgesia compared to opioid medication but it can also decrease overall opioid requirement.

In the current proposed study, the investigators wish to build on previous work. The investigators hypothesize that with the addition of Acetaminophen to Ibuprofen, patients undergoing outpatient otolaryngology procedures may not require opioid analgesia at all. While numerous studies corroborate these results, there is little information about patients' satisfaction with their care in light of a shifting emphasis on decreasing opioid prescription. The primary goal of the current study is to better understand patients' perception of care and level of satisfaction when given opioid versus non-opioid postoperative analgesia. If there is conflicting data with regards to patients reporting adequate pain control but poor satisfaction, then perhaps further public health intervention may be necessary to provide additional patient education to help re-establish appropriate and safe patient expectations for postsurgical analgesia.

Eligibility Criteria:
Inclusion Criteria:

* Patients between the ages of 18 and 89 years of age
* Patients undergoing the following outpatient procedures at a LLUHS associated surgical facility:

  * total or partial thyroidectomy
  * parathyroidectomy
  * parotidectomy
  * submandibular gland excision
  * neck mass excision
  * facial mass excision
  * MOHS defect repair
  * excision of cutaneous lesions
  * Other surgeries may qualify and will be assessed on a case by case basis.

Exclusion Criteria:

* Patients under 18 years old or older than 89 years old
* Those allergic to Hydrocodone, Acetaminophen, or NSAIDS
* Patients who are pregnant
* Patients with chronic medical conditions including hepatic/renal disease that precludes their ability to utilize the study medications.
ASSESSING THE GAY MALE EXPERIENCE WITH ANAL CANCER PREVENTION STRATEGIES

The purpose of this study is to describe current knowledge and opinions about anal cancer screening among men who have sex with men (MSM), as well as their experience receiving guideline-compliant care aimed at anal cancer risk reduction using a large-scale survey disseminated via social media.


Eligibility Criteria:
Inclusion Criteria:

* ≥18 years of age
* Current resident of the U.S.
* Engage in anoreceptive intercourse with male partners
* Fluent in English or Spanish

Exclusion Criteria:

* Under the age of 18 years old
* Not living in the United States
* Not born with sex assigned at birth as male
* Does not engage in sex with male partners
3D-CT-guided Percutaneous Radiofrequency Thermocoagulation for Tumor-related Trigeminal Neuralgia

This study is designed to investigate the effectiveness and safety of 3D-CT-guided percutaneous radiofrequency thermocoagulation for the treatment of tumor-related trigeminal neuralgia.

Approximately 1-13% of trigeminal neuralgia cases are secondary to intracranial tumors, and this condition is referred to as tumor-related trigeminal neuralgia (TRTN). TRTN can result from a lesion affecting any location along the pathway of the trigeminal nerve, such as Meckel's Cave, the posterior fossa, and the cerebellopontine angle. The posterior fossa is the most common location of TRTN, whereas meningioma and epidermoid cysts are the most common pathologies. The goals of TRTN treatment include controlling tumors and relieving pain. Tumor resection is regarded as the most effective treatment, and complete tumor removal is often followed by complete pain remission. However, for patients who cannot undergo the risk of a craniotomy and those with end-stage of malignant tumors or slow-growing benign tumors, surgery may not be the best choice. Conservatively, medication is considered the first-line therapy for relieving pain. However, pharmacology cannot provide satisfactory relief for all patients, and some patients may experience intolerable side effects. For these patients, minimally invasive interventional techniques are preferred. Radiosurgery has been commonly performed for the treatment of TRTN with promising efficacy. However, this intervention is associated with delayed latency of response. Percutaneous radiofrequency thermocoagulation (PRFT) is a low-risk, minimally invasive technique with an acute success rate of 97.6-99%. PRFT remains the most common percutaneous treatment for TN. In addition, this popular procedure may also safely and effectively be repeated if pain recurs. The PRFT procedure involves positioning the radiofrequency (RF) needle at the Gasserian ganglion via the foremen ovale. Suboptimal piercing may lead to unpleasant complications, including cerebrospinal fluid leakage, cranial nerve (VI) palsy and intracranial hemorrhage. Recently, computed tomography (CT) has been demonstrated to be a useful method to identify the optimal position and predict the intraoperative difficulties of the intervention.

Eligibility Criteria:
Inclusion Criteria:

* age\>18 years,
* typical TN symptoms in the same lateral as intracranial tumors,
* uncontrolled symptoms or intolerable side effects of medication,
* pain duration longer than 90 days
* brain magnetic resonance imaging (MRI)confirmed that the trigeminal pain was secondary to intracranial tumors.

Exclusion Criteria:

* patients with infection at the puncture site,
* coagulopathy,
* epilepsy,
* other causes of TN,
* a history of mental disorders or anesthetic drug abuse.