cyrilzakka/clinical-trials huggingface dataset:
Natural History of Human Papillomavirus (HPV) Infections in Mid-Adult Women (WHIM)

The purpose of this study is to determine rates of oral and genital human papillomavirus (HPV) infections, and look at risk factors for HPV infection in healthy mid-adult women.

The investigators propose a longitudinal study of 500 women in order to determine rates and risk factors for HPV infections in 30-50 year old women. Participants will be followed for 6 months and will be asked to complete online questionnaires on their health, sexual behavior, HPV vaccinations, and cervical cancer screening. The investigators will ask participants to self-collect monthly vaginal swab samples and self-collect 2 oral swab samples. Women will also be asked to provide 2 blood samples. All swab samples will be tested for type-specific HPV deoxyribonucleic acid (DNA) using a polymerase chain reaction (PCR)-based assay, blood samples will be tested for HPV antibodies.

Eligibility Criteria:
Inclusion Criteria:

* affiliated with the University of Washington (student, staff, faculty)
* willing to self-collect vaginal samples at home for HPV testing
* able to provide informed consent

Exclusion Criteria:

* pregnant
* have had hysterectomy
* serious medical condition which prevents completion of activities of daily living
Human Leukocyte Antigen-A*02:01-restricted Tumor Vessel Specific Peptide Vaccination for Advanced Pancreatic Cancer

Pancreatic cancer is the fourth leading cause of cancer death in the United States, and no combination therapy is far superior to gemcitabine alone. Vascular endothelial growth factor receptor type 1 (VEGFR1) is expressed on the tumor vessels and a candidate of tumor vessel-specific peptide vaccination strategy to induce T cell immune response. We conducted the study to confirm the safety and efficacy of combined modality intervention using conventional dose of gemcitabine with peptide vaccination targeting tumor-vessel specific VEGFR1 in case of advanced/inoperable or therapy-resistant pancreatic cancer patients.

Gemcitabine 1,000 mg/m\^2 (body surface area) will be administered on day 1, day 8, day 15, day 29, day 36, and day 43, respectively.

VEGFR1-derived HLA-A\*02:01-restricted peptide (VEGFR1-A02-770; TLFWLLLTL) emulsified with Montanide ISA51 will be subcutaneously injected twice weekly for 8 weeks (total 16 doses).

HLA-A\*02:01-restricted VEGFR1-specific cytotoxic T lymphocyte (CTL) responses were obtained from HLA-A2/Kd transgenic murine model.

HLA-A\*02:01-restricted VEGFR1-specific CTL clones were also obtained from peripheral blood mononuclear cells of healthy volunteer donors.

These CTL clones showed potent anti-tumor CTL responses in HLA class Ⅰ-restricted manner in vitro.

Vaccination of HLA-A\*02:01-restricted VEGFR1-specific peptide to A2/Kd transgenic mice markedly suppress the tumor-induced angiogenesis and tumor growth in vivo.

Eligibility Criteria:
Inclusion Criteria:

* Heterozygote or homozygote of HLA-A\*02:01 allele
* Inoperable or recurrent pancreatic cancer with or without any prior therapy
* Difficult to continue the prior therapy due to treatment-related toxicities
* ECOG performance status 0-2
* Evaluable primary or metastatic lesion with RECIST v.1.0 criteria
* Clearance period from prior therapy more than 4 weeks
* Life expectancy more than 3 months
* Laboratory values as follows 2,000/μL\< WBC \<15,000/μL Platelet count \>100,000/μL AST \<150 IU/L ALT \<150 IU/L Total bilirubin \<3.0 mg/dl Serum creatinine \<3.0 mg/dl

Exclusion Criteria:

* Pregnancy (refusal or inability to use effective contraceptives)
* Breastfeeding
* Active or uncontrolled infection
* Systemic use of corticosteroids or immunosuppressants
* Uncontrollable brain metastasis and/or meningeal infiltration
* Unhealed external wound
* Possibilities of complicated paralytic ileus or interstitial pneumonitis
* Decision of not eligible determined by principal investigator or attending doctor
A Double-Blind, Placebo-Controlled, Dose Ranging Study of Xanamem® in Healthy Elderly Volunteers

Xanamem® is being developed as a potential drug for Mild Cognitive Impairment in Alzheimer's disease. This study drug has been designed to change the cortisol levels in the brain. Cortisol is a naturally occurring hormone in the body. It is believed that reducing the level of cortisol will be a benefit in the treatment of Mild Cognitive Impairment in Alzheimer's disease.

The purpose of this study in older volunteers is to investigate the smallest dose of Xanamem® (5 mg or 10 mg) which works and to investigate which dose in this study will be used in the upcoming clinical trials in patients.


Eligibility Criteria:
Inclusion Criteria:

1. Male or female aged 50 to 80
2. Body mass index 17.5 to \< 35 kg/m2, inclusive at the time of screening
3. Mini-Mental State Score of ≥ 25 points at screening
4. Must provide written informed consent

Exclusion Criteria:

1. Abnormalities in vital signs at screening or baseline
2. Clinically significant abnormal hematology or biochemistry values, as determined by the investigator at screening and/or baseline.
3. Previous clinically significant systemic illness or infection within the past 4 weeks prior to screening or baseline, as determined by the investigator
4. Clinically significant ECG abnormalities
5. Use of tobacco- or nicotine-containing products in the past month or unwillingness to abstain during study participation
6. Participation in another clinical study of a drug or device
7. Known allergy to the study drug (Xanamem®) or any of the excipients
8. Subjects who are likely to be unable to comply with the study schedule and/ or subjects with an inability to communicate well with the investigator
9. Positive testing for human immunodeficiency virus (HIV), hepatitis B surface antigen, or hepatitis C antibodies at screening
10. Subjects with a history of drug abuse or addiction in the past 5 years.
11. Evidence of alcohol abuse (defined as greater than 21 standard units per week for males and greater than 14 standard units per week for females)
The Effectiveness of Vibrational Applications on Orthodontic Treatment

The aim of this study is to determine whether vibrational applications, as an adjunct to orthodontic forces, increases the rate of tooth movement in patients with fixed orthodontic appliances.

Nineteen patients who had class 2 division 1 malocclusion or severe crowding and needed first premolar extractions as a treatment modality were included to the study. The patients were divided into two groups, 8 in control and 11 in the study. The subjects assigned to study group were applied suplementary vibrational forces for 20 min/daily. 3-dimensional digital models were generated just before canine distalization and after space closure by 3Shape TRİOS R700 (3Shape Inc., Copenhagen, Denmark) device. The linear measurements between molars and canines were evaluated. The results were assessed with SPSS 23.0 programme (lBM SPSS Statistics for Windows, NY, USA). The amount of tooth movement for all samples were measured twice by the responsible investigator at one week interval. Interclass correlation coefficient-ICC was used to asses intraobserver accuracy and reliability.Mann- Whitney U test was used to assess treatment effect in terms of time to reach canine distalization. Correlation between measurements were described with Spearman Correlation Coefficient. Interclass correlation was 95%, which is in the range of excellent measurement agreement.

Eligibility Criteria:
Inclusion Criteria:

* patients who were planned first premolar extractions
* demonstrated good oral hygiene

Exclusion Criteria:

* patients with poor oral hygiene and have periodontal problem
A Clinical Pharmacology Study of MT-2990 in Seasonal Allergic Rhinitis Patients

The objective of this study is to investigate the safety, tolerability, and pharmacokinetics of MT-2990 in patients with Japanese cedar pollen-induced seasonal allergic rhinitis (JC-SAR). Additional objective of the study is to investigate the efficacy and pharmacodynamics profile of MT-2990 in an environmental exposure chamber (EEC) on Day 8, 29, 57, and 85.


Eligibility Criteria:
Inclusion Criteria:

* A body weight of 40 to 100 kg for female or 45 to 100 kg for male
* A body mass index of 18 to 30 kg/m2
* Subjects who have current history of JC-SAR in previous 2 consecutive years.
* Presence (CAP-RAST: ≥2) of IgE specific to Japanese cedar pollens and absence (CAP-RAST: ≤1) of IgE specific to other 4 allergens
* Presence of at least 2 symptoms, which are moderate to very severe, in 4 nasal symptoms (runny nose, sneezing, blocked nose, itchy nose) at any time point during allergen exposure in EEC at screening period

Exclusion Criteria:

* Presence of any symptoms of allergic rhinitis within 1 year except scattering season of cedar pollen or cypress pollen
* Subjects who have persistent symptom caused by allergen exposure in EEC at screening period until Day 1 (pre-dose)
* Underwent nasal surgery (include laser surgery) to improve nasal symptoms within 2 years
* Underwent specific immunotherapy or non-specific immunotherapy within 5 years
* Underwent medication of anti-histamine, oral mast cell stabilizer, leukotriene receptor antagonist, prostaglandin D2/thromboxane A2 receptor antagonist, Th2 cytokine inhibitor, corticosteroid (oral form, intra-nasal form, ocular form), or vasoconstrictor within 4 weeks
* Underwent medication of corticosteroid (injection form) or anti-IgE antibody within 6 months
* Subject who is concerned about exacerbation of the physical condition due to allergen exposure in EEC
Adjunctive Aripiprazole in the Treatment of Risperidone-Induced Hyperprolactinemia

Hyperprolactinemia is a frequent consequence of treatment with typical antipsychotic agents and atypical antipsychotics such as risperidone. Recent studies have suggested that aripiprazole, a partial dopamine agonist, reduces the prolactin response to antipsychotics. Thus, we conducted this study to evaluate the dose effects of adjunctive treatment with aripiprazole on hyperprolactinemia in stable schizophrenic patients maintained with risperidone.


Eligibility Criteria:
Inclusion Criteria:

1. aged 18-45 years of and fulfilled Diagnostic and Statistical Manual of Mental Disorders(DSM-IV )criteria (American Psychiatric Association, 1994) for schizophrenia;
2. having a stable psychiatric condition, defined as taking the same dosage of risperidone for at least 6 weeks;
3. being treated with risperidone monotherapy; and presence of hyperprolactinemia associated with risperidone.

Exclusion Criteria:

1. any other major psychiatric disorder;
2. significant concurrent medical illnesses, organic brain disorder, history of substance and alcohol abuse, and mental retardation
AME Study of [14C]-PC14586 in Healthy Male Participants

This study will assess the PK and rates of elimination and mass balance of total radioactivity from \[14C\]-PC14586

PC14586 is a first-in-class, oral, small molecule p53 reactivator that is selective for the TP53 Y220C mutation. The study will assess the PK, absorption, metabolism, and excretion of \[14C\]-PC14586 following a single dose in healthy male participants.

The aim is to recruit approximately 8 participants with a minimum number of 6 evaluable participants.

Each participant will be admitted to the study site pre-dose on Day -1 and will remain at the study site until at least Day 14. Participants will receive a single administration of \[14C\]-PC14586 as oral capsules on Day 1. During this study, whole blood, plasma, urine, feces, and vomit samples (if presented) will be collected at various timepoints to characterize the absorption, metabolism, excretion, and PK of \[14C\]-PC14586.

The duration of the residential period will be evaluated following the administration of \[14C\]-PC14586 and may be extended to ensure recovery of at least 90% of the total radioactivity, or until less than 1% of dose is recovered in urine and/or feces.

Eligibility Criteria:
Inclusion Criteria:

1. Healthy, non-smoking males of any race, between 18 and 55 years of age, with BMI between 18.0 and 32.0 kg/m2 inclusive.
2. In good health, determined by no clinically significant findings from medical history and evaluations at screening and check-in as assessed by the investigator.
3. Agree to use a highly effective method of contraception from check-in through 90 days after discharge.
4. History of a minimum of 1 bowel movement per day.
5. Creatinine clearance ≥90 mL/min determined using the Cockcroft-Gault equation.
6. Able to swallow capsules.

Exclusion Criteria:

1. Significant history or clinical manifestation of any medical condition, disease or disorder, as determined by the investigator.
2. Blood pressure \>140 mm systolic or \>90 diastolic at screening or Day -1.
3. Positive hepatitis panel and/or positive human immunodeficiency virus test
4. Use or intend to use any prescription and/or nonprescription medications/products within14 days prior to check-in.
5. Participation in a clinical study involving last administration of an investigational drug within the past 30 days prior to dosing, or within 5 half-lives of the IMP, whichever is longer, or who have participated in more than 3 radiolabeled drug studies in the last 12 months.
6. Participants who have previously completed or withdrawn from this study or any other study investigating PC14586, or have previously received PC14586.
7. Participants with a history of alcoholism or drug/chemical abuse within 2 years prior to check-in, use of tobacco or nicotine-containing products within 3 months prior to check-in or with a positive drug and/or alcohol test result at check-in.
8. A positive p53 Y220C germline test at screening
Single Dose Phase I Study of FYU-981

The purpose of this study is to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of single doses of FYU-981 administered orally to healthy male adults in fasted and fed conditions. Participants are randomized to placebo (n=3) or FYU-981 (n=6) in each step. After follow-up examination in the step of lower dose, the next dose is administered. The effect of food on PK/PD of FYU-981 is also investigated.


Eligibility Criteria:
Inclusion Criteria:

* Japanese healthy adult subjects
* Body mass index: \>=18.5 and \<25.0

Exclusion Criteria:

* Subjects with any disease or any history of diseases that might be unsuitable for participation in the clinical study
Contribution of Hypnosis to Anxiety and Pain in Brachytherapy Patients

Formal hypnosis is a non-drug technique known to decrease anxiety and pain during the preoperative procedure.

In brachytherapy, the practice of hypnosis has been shown to be feasible and beneficial for patients treated for prostate cancer The goal of the study is to demonstrate the added value of hypnosis during a brachytherapy detachment by improving the comfort of the patient.

The investigators want to evaluate the contribution of hypnosis during brachytherapy detachment by quantifying the anxiety and pain felt by the patient during the procedure.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients ≥ 18 and ≤ 80 years
* Patients expected to benefit a brachytherapy detachment Under KALINOX® for one of the types of applications described below:

  * Deep interstitial application: anal canal, vagina, vulva
  * Gynecological application: mold, Utrecht® system or Venezia® system
* Ability to provide written informed consent
* Patients affiliated to the social security system

Exclusion Criteria:

* Minor and patients over 80 years old
* Patients with major hearing loss
* Patients who had recent ocular surgery with oculiare gas injection.
* Patients suffering from psychotic disorders, and dementias.
* Patients who do not understand the French language
* Patients under guardianship or deprived of liberty
* Patients with a contraindication to the administration of KALINOX®
Transcriptional Framework for the Molecular Diagnosis of Response to Immunotherapy in Lung Cancer With Agnostic Potential

Through genomic and transcriptomic sequencing techniques (whole exome sequencing, WES; whole transcriptome sequencing, WTS) patients with enrichment for KEAPness and specific gene interactions associated with it.

Retrospective-prospective, non-pharmacological, biological, multicenter observational study, for which the collection and use of tissue samples from patients suffering from NSCLC and/or other tumor types. Through genomic and transcriptomic sequencing techniques (whole exome sequencing, WES; whole transcriptome sequencing, WTS) patients with enrichment for KEAPness and specific gene interactions associated with it. Subsequently, through the same techniques, applied to different tumor regions taken from operating site it will be possible to identify the evolution of the tumor at a spatio-temporal level and the immune subtype associated with the presence/absence of KEAPness. Finally, cell lines will be used to recapitulate what was observed in the patient and per-patient cohorts identify new pharmacological vulnerabilities associated with the characteristics of KEAPness.

Eligibility Criteria:
Inclusion Criteria cohort (NSCLC-IC):

* Age \>18 years;
* Histological diagnosis of NSCLC
* metastatic disease
* Availability, at the time of enrollment, of adequate biological material to be able to perform molecular analyses, taken (surgical or by biopsy) before administration of any anti-tumor treatment (chemotherapy and/or radiotherapy);
* ECOG PS 0-2;
* Adequate hematological, hepatic and renal function;
* Measurable disease according to RECIST criteria
* Availability of follow-up data for at least 6 months and/or until death/progression

Exclusion Criteria cohort (NSCLC-IC):

* Previous systemic therapy for metastatic disease;
* Comorbidities not controlled with adequate medical therapy.

Inclusion Criteria NSCLC-VC cohort:

* Age \>18 years;
* Histological diagnosis of NSCLC
* metastatic disease
* Availability, at the time of enrollment, of adequate biological material to be able to perform molecular analyses, taken (during surgery and/or by biopsy) before administration of any anti-tumor treatment (chemotherapy and/or radiotherapy);
* ECOG PS 0-2;
* Adequate hematological, hepatic and renal function;
* Measurable disease according to RECIST criteria;
* Written informed consent (participation in the study and data processing)

Exclusion Criteria NSCLC-VC cohort:

* Previous systemic treatment for metastatic disease;
* Comorbidities not controlled with adequate medical therapy;
Follow-up Study After 11 Years of Patients Who Were Included in the BENEFIT Trial (304747) With a First Demyelinating Event Suggestive of Multiple Sclerosis

This study assesses clinical and imaging long-term data, after early or delayed interferon-beta-1b treatment in patients with a first demyelinating event suggestive of multiple sclerosis (MS), 11 years after enrollment in the Betaferon/Betaseron in Newly Emerging Multiple Sclerosis for Initial Treatment (BENEFIT) study (304747). The main objectives are to describe the disease course, change in disability, cognitive function, resource use and employment status, in relation to Interferon beta-1b in the long term.

As optic coherence tomography (OCT) and magnetic resonance imaging (MRI) studies are essential to standardize the procedures and assessments for all OCT and MRI test centers that may take part in this study, 122 additional volunteers will be enrolled to test the dummy scans of OCT and MRI, only.

Eligibility Criteria:
Inclusion Criteria:

* Male and female patients with clinical-isolated syndrome or multiple sclerosis who have been treated at least once in BENEFIT Study 304747

Exclusion Criteria:

* Patients who, according to the investigator's judgment, have medical, psychiatric, or other conditions that compromise the patient's ability to understand the purpose of the study
Treatment of Hemodialysis Catheter-Related Bacteremia

Patients who undergo hemodialysis via a tunneled catheter often develop bloodstream infections that arise from the catheter. There are several management options for treatment of such an infection, though the best option is not clearly delineated. Standard of care options include exchanging the catheter for a new one over a guide-wire and instilling a high concentration of an antibiotic directly into the catheter lumen. The investigators are planning to treat hemodialysis catheter bloodstream infections by one of two strategies: 1. Use of a novel antibiotic lock solution Or 2. Changing out the infected catheter for a new one. Both these options have comparable cure rates as shown in the medical literature. After obtaining informed consent, patients will be randomized to either treatment arm and will continue to receive all other standard medical care.

Specific Aim: To conduct a randomized clinical trial to demonstrate that the use of a novel antibiotic lock solution (consisting of N-acetylcysteine, tigecycline and heparin) is non-inferior to guide-wire exchange in the treatment of hemodialysis catheter-related bacteremia.


Eligibility Criteria:
Inclusion Criteria:

* Any adult (≥ 18 years of age) who has ESRD and a prevalent or incident tunneled hemodialysis catheter with bacteremia will be eligible for enrollment.

Exclusion Criteria:

* The following patients will be excluded: 1) patient is unable (and no guardian or legal representative is available) or unwilling to provide informed consent, 2) patient is allergic to NAC, tigecycline, minocycline, or heparin, 3) patient has evidence of a complicated bacteremia such as endocarditis, septic thrombophlebitis, septic emboli, osteomyelitis, deep seated abscess, or hypotension requiring use of vasopressors, 4) patient has evidence of an exit site infection around the catheter such as a pus pocket, purulent drainage, or erythema, 5) patient is pregnant or will become pregnant, 6) the infection is due to an organism that is resistant to tigecycline such as Candida or Pseudomonas species.