cyrilzakka/clinical-trials huggingface dataset:
S-1 or Tegafur-Uracil in Treating Patients With Previously Treated Stage III or Stage IV Head and Neck Cancer

RATIONALE: Drugs used in chemotherapy, such as S-1 and tegafur-uracil, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving S-1 or tegafur-uracil after surgery, chemotherapy, biological therapy, and/or radiation therapy may kill any remaining tumor cells. It is not yet known whether S-1 is more effective than tegafur-uracil in treating head and neck cancer.

PURPOSE: This randomized phase III trial is studying S-1 to see how well it works compared with tegafur-uracil in treating patients with previously treated stage III or stage IV head and neck cancer.

OBJECTIVES:

* Compare the disease-free survival rate in patients with definitively treated stage III or IV squamous cell carcinoma of the head and neck treated with adjuvant chemotherapy comprising S-1 vs tegafur-uracil (UFT).

OUTLINE: This is a randomized, controlled, multicenter study. Patients are stratified according to primary site, disease stage, type of prior definitive treatment, and participating center. Patients are randomized to 1 of 2 treatment arms.

* Arm I: Patients receive oral S-1 once daily on days 1-14. Courses repeat every 21 days for 1 year in the absence of disease progression or unacceptable toxicity.
* Arm II:Patients receive oral tegafur-uracil (UFT) once daily on days 1-21. Courses repeat every 21 days for 1 year in the absence of disease progression or unacceptable toxicity.

PROJECTED ACCRUAL: A total of 500 patients will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Histologically or cytologically confirmed squamous cell carcinoma of the head and neck (SCCHN)

  * Stage III or IV disease
  * Primary tumor in the mesopharynx, hypopharynx, larynx (except T3 N0 tumors of the glottis), oral cavity, or maxillary sinus
* Completed definitive treatment for SCCHN within the past 3 months, that included any of the following:

  * Surgery
  * Chemotherapy
  * Biologic therapy
  * Radiotherapy (e.g., radiotherapy in combination with chemotherapy or pre- or postoperative radiotherapy)
  * Any other treatment
* No clinical evidence of locoregional tumors or distant metastasis within 3 months after the completion of definitive treatment

PATIENT CHARACTERISTICS:

* ECOG performance status 0-1
* WBC ≥ 3,500/mm\^3 AND ≤ 12,000/mm\^3
* Neutrophil count ≥ 2,000/mm\^3
* Platelet count ≥ 100,000/mm\^3
* Hemoglobin ≥ 9 g/dL
* AST and ALT \< 100 IU/L
* Bilirubin \< 1.5 mg/dL
* Creatinine \< 1.2 mg/dL
* No uncontrolled cardiovascular disease
* No interstitial pneumonia or pulmonary fibrosis
* Must have sufficient oral intake

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics
* No concurrent biologic therapy, radiotherapy, other chemotherapy, or any other therapy
IBD-Sleep: A Pilot Study Looking at Changes in Sleep Timing and IBD Symptoms

This research study is testing whether changes in sleep timing and morning light treatment may have an impact on symptoms related to inflammatory bowel disease.

This study will test a consumer health light therapy device (Re-Timer) for people with inflammatory bowel disease to better understand how it affects IBD-related quality of life.

Eligibility Criteria:
Inclusion Criteria:

* Biopsy-proven IBD
* Active IBD symptoms
* Impaired IBD quality of life
* Age \>/=18 years old
* Fluency in English
* Physically able to travel for study visits

Exclusion Criteria:

* Ileostomy, colostomy, ileoanal pouch, or ileorectal anastomoses, are planned for imminent surgery and/or have short bowel syndrome
* Other significant chronic disease
* Retinal pathology, history of eye surgery, taking photosensitizing medications
* Recent history of light treatment
* Lifetime psychotic or bipolar disorder
* Acute suicidal ideation
* Substance use disorder in the past 3 months, cannabis use \>1/week
* High risk for or diagnosed with obstructive sleep apnea, and/or narcolepsy
* Severe hearing problem, intellectual disability or serious cognitive impairment
* Pregnant, trying to get pregnant, or breastfeeding
* Night work or travel outside the eastern time zone in the past month
The Effects of Hydromorphone on Responses to Verbal Tasks

In this study, the investigators will examine the effects of hydromorphone, as compared to placebo, upon physiological, subjective, and hormonal responses to a stressful speech task and a non-stressful control task in healthy adults. There is strong evidence in support of the role of endogenous opioids and opiates in mediating social behavior in humans and other animals, and particularly, in social distress. The investigators have recently shown that buprenorphine, a partial mu-opioid agonist, reduces cortisol responses to stress. Here, the investigators propose to further explore the role of the opioid system in mediating stress responses in humans through the use of hydromorphone, a full mu opioid agonist, in addition to acetaminophen. The investigators hypothesize that like acetaminophen, hydromorphone will reduce both physiological and subjective measures of stress.

Participants be randomly assigned to receive 1000 mg acetaminophen, 2mg hydromorphone, 4mg hydromorphone, or placebo at each of two sessions; one during which they well participate in a stressful speaking task, and one during which they'll participate in a nonstressful control task. Physiological and subjective measures will be taken throughout each session.

Eligibility Criteria:
Inclusion Criteria:

* Healthy adult volunteers

Exclusion Criteria:

1. any current medical condition requiring medication or abnormal electrocardiogram
2. current or past medical condition considered to be a contraindication for the study conditions
3. any current Axis I psychiatric disorder (APA, 1994) including Substance Use Disorder, or Anxiety Disorder or Major Depression in the past year, any history of psychosis
4. less than high school education
5. lack of fluency in English
6. night shift work
7. Pregnancy, lactation or plans to become pregnant.
8. Use of hormonal contraception.
9. Daily cigarette smokers i.e., \>7 cigarettes per week
A Post Marketing Surveillance Study Assessing the Long-term Efficacy and Safety of Aptivus Co-administered With Low-dose Ritonavir in Treatment Experienced Patients With HIV-1 Infection in the Daily Clinical Practice.

The aim of this trial is to evaluate the safety and virological and immunological efficacy of Aptivus in treatment-experienced patients with advanced HIV-1 infection who had developed resistance to more than one protease inhibitor.


Eligibility Criteria:
Inclusion criteria:

1. HIV-1 infected patients who are treatment experienced and infected with HIV-1 strains resistant to more than one protease inhibitor and no other therapeutic options.
2. The inclusion criteria follow the same criteria which are describe in the newest SPC

Exclusion criteria:

The exclusion criteria follow the same criteria which are describe in the newest SPC
Tryptophan Requirement of Healthy School Age Children

Our objective is to determine the requirement for the amino acid tryptophan in school age children using the indicator amino acid technique.

Seven healthy children will participate in the study. The children will participate as an outpatient basis with study days carried out in the Physiological Research Unit at the Hospital of Sick Children, Toronto, Canada. Inclusion criteria include: being healthy, not taking any medications, no recent weight changes, no history of significant illness, willing to participate in the study. Exclusion criteria were the presence of illness, significant weight change, not acceptance of the diet. Prior to enrolment, each subject will have to fill 3 days food record form to ensure his or her normal dietary behavior. The study will be explained to subjects and their parents/guardians, benefits and potential risks will be explained as well and written assent, from the children, and consent from parents will be obtained. Subjects will receive financial compensations. Each subject will receive compensation for participation. Each parent/guardian will be reimbursed for the transpiration/parking expenses and a meal each study day.

Eligibility Criteria:
Inclusion Criteria:

* Healthy children age 6-10 inclusive

Exclusion Criteria:

* significant recent illness
Impact of Maternal Body Weight on Vitamin D Status During Pregnancy

Research shows high levels of vitamin D deficiency in pregnant women in Northern Ireland. Body composition is a determinant of vitamin D status. Vitamin D is a fat soluble vitamin and therefore may be hidden within the adipose/fat tissue in overweight/obese individuals. All pregnant and breastfeeding women are advised to take a daily supplement containing 10μg vitamin D. The investigators hypothesise that overweight/ obese pregnant women have a lower vitamin D status than their leaner counterparts at the start of pregnancy and may need a higher daily supplementation to achieve a sufficient status.

The investigators propose a randomised supplementation study where pregnant women (n 240) from the Western Health and Social Care Trust Area will be invited to take part.

Inclusion criteria: pregnant women first trimester, without current pregnancy related complications, singleton pregnancy, aged ≥18 years, with Body Mass Index (BMI) \> 18.5kg /m².

Participants will be randomised to receive either 0μg (placebo) plus a multivitamin or 10μg vitamin D plus a multivitamin from 12 weeks gestation until delivery. The multivitamin already contains 10μg vitamin D; Therefore participants will be randomised to receive a total of 10μg or 20μg vitamin D.

Blood samples (20mls) will be taken at 12, 28 and 36 weeks gestation. A sample of blood will be taken from the cord after delivery. Vitamin D status is the main outcome measurement. All blood samples will be analysed for vitamin D and other associated metabolites. Data will be collected on health and lifestyle, supplementation use and food intake. Body composition measurements will be recorded at each appointment and infant anthropometric measurements will be taken from the maternal notes after delivery. Findings from this research will be used to inform nutrition policy on appropriate vitamin D supplementation levels in pregnancy which may be dependent upon pre pregnancy BMI.


Eligibility Criteria:
Inclusion Criteria:

* Pregnant women
* Age ≥18years
* BMI \>18.5 kg/m²
* Without current pregnancy related complications
* At least 12 weeks gestation
* Have a singleton pregnancy (as confirmed at first scan)
* Pregnant women who are currently taking vitamin D and have had a sun holiday will be included in this study. All participants will agree to discontinue any current supplementation and will be provided with a multivitamin for the duration of pregnancy.

Exclusion Criteria:

* Aged \<18 years
* Pregnancy BMI \<18.5kg/m²
* Participants with multiple pregnancy
* Participants currently involved in another research study
* Participants with a history of gastrointestinal, hepatic, renal, vascular or haematological disorders.
* Participants who have had in vitro fertilisation (IVF) treatment
* Participants with a history of NTD affected pregnancies
* Pregnant women with active thyroid disease (e.g., Graves, Hashimoto or thyroiditis)
* Planned home births
The Role of Bexarotene in Inducing Susceptibility to Chemotherapy in Metastatic TNBC

Triple-negative breast cancer (TNBC) is biologically aggressive and has limited systemic treatment options, often compounded by treatment resistance.

Cell state transitions, e.g. epithelial-to-mesenchymal transition (EMT) govern cancer cell behaviour.

The investigators hypothesize that by inducing change in cell state change, TNBC cells that have manifested taxane-resistance will be more sensitized to subsequent chemotherapy.


Eligibility Criteria:
Inclusion Criteria:

* Patients with histologically or cytologically proven metastatic TNBC
* Patients whose TNBC has progressed after prior taxane therapy in the (neo)adjuvant or metastatic setting, and have not received Capecitabine or 5-fluorouracil
* Females aged 21 years and older
* ECOG performance status 0 or 1
* Life expectancy greater than three months
* Patients have normal organ and marrow function
* Site(s) of disease amenable to serial bedside biopsies before, during and after study treatment

Exclusion Criteria:

* Previous palliative radiotherapy to potentially biopsy-able lesion
* Active symptomatic central nervous system (CNS) metastases
* Spinal cord compression not definitively treated with surgery and/or radiation
* Uncontrolled pleural effusion, pericardial effusion, ascites requiring recurrent drainage procedures
Posterior Capsule Opacification (PCO) With AcrySof Single-Piece IOL

The purpose of this study what to evaluate if axial myopia might influence the development of PCO.

We sought to prospectively compare PCO in eyes with myopia in relation to axial length with PCO in eyes with normal axial length, to decipher the role of axial myopia in PCO 4 years after surgery for senile cataract.

Eligibility Criteria:
Inclusion Criteria:

* local residency and presence of a cataract in an otherwise normal eye.
* Patients older than 50 years
* a dilated pupil after mydriasis
* Patients with retinochoroidal atrophy, retinal laser prophylaxis,
* hypertension

Exclusion Criteria:

* nondilating pupil after maximal dilation;
* pseudoexfoliation; mature, traumatic, black, or complicated cataracts;
* previous intraocular surgery;
* previous surgery for glaucoma;
* uveitis
* diabetes mellitus
* Patients who did not give consent preoperatively
Persistent Pain After Breast Cancer Treatment With Docetaxel

Breast cancer treatment is for many patients followed by sequelae, such as persistent pain, sensory disturbances, lymphedema and reduced physical function. These undesired consequences of the treatment are a major clinical problem, with persistent pain affecting 25-60%, sensory disturbances 20-80%, lymphedema 2-86% and reduced physical function 13-28% of patients. Development of persistent pain after breast cancer treatment, involves a complex pathophysiology that involves pre-, intra- and postoperative factors. Several risk factors for the development of persistent pain after breast cancer treatment have been identified; young age, psychosocial factors, surgical procedure and radiation therapy. Neurotoxicity is a well know attribute of many chemotherapeutic agents, such as taxanes. The purpose of this nationwide study is to retrospectively examine a cohort of breast cancer patients treated with docetaxel, to clarify if docetaxel may influence the prevalence and intensity of persistent pain and other sequelae.


Eligibility Criteria:
Inclusion Criteria:

* Treated for primary breast cancer in Denmark 2007-2008
* Age between 18-80 years
* No recurrent cancer
* Female

Exclusion Criteria:

* Previous breast surgery same side (including plastic and reconstructive surgery)
* Bilateral breast surgery
* Recurrent cancer or metastatic cancer
Spironolactone for Hidradenitis Suppurativa

The purpose of this study is to evaluate if the drug spironolactone - which is used to treat acne and male pattern hair growth in women - is effective in treating hidradenitis suppurativa in females and which dose of the drug works the best. Participation in this study will take about 4 clinic visits over approximately 7 months with the option to continue for longer if desired.


Eligibility Criteria:
Individuals will be screened for eligibility by a screening visit conducted by named investigators.

Inclusion Criteria To be eligible for the study: (All answers must be "YES" for subject to be eligible.)

1. Subject must have clinically diagnosed hidradenitis suppurativa, with an inadequate response to other treatment modalities, including but not limited to local or systemic antibiotics, immunosuppressive agents, retinoids, biologic therapies, surgical management.
2. Subject disease severity must be classified as 'mild' or more severe on the HS-PGA Scale at screening exam, because subjects classified as 'clear' or 'minimal' on the scale will be unable to achieve the prespecified treatment response.
3. Subject must be a female.
4. Subject must be 18-70 years of age.
5. Women of child-bearing potential must be on effective contraception. Acceptable methods of contraception include oral contraceptive pills (OCPs), hormonal or copper IUDs, contraceptive implants, contraceptive injections, birth control patches, vaginal rings, condom, sponge, diaphragm with spermicide, or prior surgical sterilization.
6. Subject must provide written informed consent prior to any study-related procedures being performed.
7. Subject must be willing to comply with all clinical study procedures.

Exclusion Criteria The presence of the following excludes subjects from the study: (All answers must be "NO" for subject to be eligible.)

1. Subject has previously received spironolactone or another antiandrogenic treatment for hidradenitis suppurativa.
2. The subject is a pregnant or nursing female.
3. Subject is hyperkalemic, defined by a potassium level of greater than 5.1 mEq/liter.
4. Subjects with Addison's disease.
5. Subjects taking eplerenone or other potassium-sparing diuretics, lithium, cholestyramine, ACE inhibitors/angiotensin II antagonists/aldosterone blockers, or NSAIDS.
6. Subjects receiving potassium supplementation.
7. Subjects with history of renal disease or an eFGR \< 30.
8. Subjects with acute or chronic liver failure.
9. Subject has an acute psychiatric condition that impairs ability to give consent or follow study protocols.

   * All races and ethnicities will be considered for inclusion in the study.
   * Males will be excluded from this study due to the high incidence of gynecomastia and sexual dysfunction seen in spironolactone use at higher doses in men. It is not routinely used to treat dermatologic conditions in men due to its poor tolerability.
   * Subjects under the age of 18 will not be considered for inclusion in this study. The disease most often manifests during the second and third decades of life, therefore the disorder is far less prevalent in children and adolescents.2
Follow Up Safety Study of SCH 420814 in Subjects With Parkinson's Disease (P05175)

The purpose of this study is to assess the long term safety of SCH 420814 (preladenant) in participants with moderate to severe Parkinson's Disease who are taking an L-Dopa/dopa decarboxylase inhibitor and/or dopamine agonist. All participants must have participated in the main study (P04501; NCT00406029) entitled "A Phase 2, 12 Week, Double Blind, Dose Finding, Placebo Controlled Study to Assess the Efficacy and Safety of a Range of SCH 420814 Doses in Subjects With Moderate to Severe Parkinson's Disease Experiencing Motor Fluctuations and Dyskinesias."


Eligibility Criteria:
Inclusion Criteria:

* Participants must have participated in P04501.
* Participants must be \>=30 years of age, with a diagnosis of moderate to severe idiopathic Parkinson's disease.
* Participants must have been on a regimen of L-Dopa and/or a dopamine agonist.

Exclusion Criteria:

* Participants who discontinued from Study P04501 because they experienced a serious adverse event (SAE)
* Participants with any form of drug-induced or atypical parkinsonism, cognitive impairment, or psychosis
* Participants taking tolcapone
* Participants who are participating in any other clinical study
Evaluation of the Incidence of Cancer in the Follow-up of Women With 3 Consecutive Embryonic Demises Before 10 Weeks or 1 Fetal Death, According to Their Thrombophilia Status, With a Special Focus on Women With an Obstetric Antiphospholipid Symdrome (oAPS)

A number of case reports describe the association of antiphospholipid antibodies (aPL Abs) with hematological and solid organ malignancies. Especially in elderly patients, thrombotic events associated with aPL Abs can be the first manifestation of malignancy. Cancer-associated monoclonal gammopathy of the IgM type can be accompanied by positive lupus anticoagulant (LA) or an anticardiolipin (aCL) IgM. Cancer and antiphospholipid antibody syndrome (APS) can coexist in sporadic cases, while some cancer patients with or without thrombosis may show some transitory aPL Ab positivity, the most striking symptomatic clinical feature, catastrophic APS, being even described in cancer patients.

Some reports suggest a significant incidence of malignancies in APS patients. Cancer was the 2nd cause of death (13.9%), after bacterial infection, during the 10-year follow-up of the 1,000 APS patients studied by the Euro-Phospholipid Project Group, but no control group was simultaneously evaluated. The risk of cancer in patients with APS is thus still uncertain.

The Nîmes Obstetricians and Haematologists APS (NOH-APS) study was based on the recruitment of a cohort of women with no history of thrombosis, who had experienced pregnancy loss fulfilling the clinical criteria of obstetrical APS (oAPS), who were either positive for aPL Abs (APS group), or positive for the F5 rs6025 or F2 rs1799963 polymorphism (Thrombophilia group), or negative for thrombophilia screening (Control group). We now want to assess the comparative incidence of cancer in women for whom an oAPS diagnosis had been made. This evaluation will be carried out during the 2017 medical follow-up step, corresponding to a median follow-up of 17 years. An external, local population-derived control group, the registry of tumors in Montpellier area (Registre des Tumeurs de l'Hérault) will be used to compute standardized incidence ratios (SIRs).


Eligibility Criteria:
Inclusion Criteria:

Women initially included into the NOH-APS cohort (N=1,592): no history of thrombosis, pregnancy loss fulfilling the clinical criteria of obstetrical APS, i.e. 3 unexplained consecutive embryonic demises before 10 weeks or 1 unexplained fetal death

Exclusion Criteria:

Women included into the NOH-APS cohort, lost to follow-up (N=37).