cyrilzakka/clinical-trials huggingface dataset:
Different Factors Affecting Patients With Newly Diagnosed Bladder Cancer

RATIONALE: Studying different factors that effect patients with newly diagnosed bladder cancer may help doctors learn more about the disease, improve the ability to plan cancer treatment, and help patients live more comfortably.

PURPOSE: This clinical trial is studying different factors affecting patients with newly diagnosed bladder cancer.

OBJECTIVES:

* To assess the effect of lifestyle factors (e.g., smoking, dietary habits, fluid intake, or environmental exposures) on the recurrence and progression of bladder cancer.
* To assess the impact of selenium and/or vitamin E on the progression and recurrence of bladder cancer.
* To study health-related quality of life and its association with recurrence and progression of bladder cancer.
* To establish a bladder cancer tissue bank that will comprise blood, urine, and bladder tissue.
* To study the predictive effect of molecular markers on the recurrence and progression of bladder cancer.

OUTLINE: This is a multicenter study.

The study will be based on a cohort of patients with newly detected bladder cancer in all 16 urological centres within the West Midlands, commencing in late 2005 for a period of 5 years. This research project consists of 5 individual studies: CRUK-BCPP-2005-01-COHORT, CRUK-BCPP-2005-01-MARKERS, CRUK-BCPP-2005-01-QOL, CRUK-BCPP-2005-01-TISSUE-BANK, and CRUK-BCPP-2005-01-TREATMENT. Patients may participate in all or only some of these individual studies.

Peer Reviewed and Funded or Endorsed by Cancer Research UK.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Bladder lesion with cystoscopic characteristics compatible with urothelial cancer or transitional cell carcinoma meeting 1 of the following criteria:

  * Non-muscle-invasive tumor
  * Muscle-invasive tumor
  * Solitary G1 pTa tumor
* No previous diagnosis of cancer of the urethra, bladder, ureter, or renal pelvis within the 10 years prior to current diagnosis

PATIENT CHARACTERISTICS:

* Fit for cystoscopy and surgical biopsy/resection
* No HIV infection
* No condition that, in the opinion of the local investigator, might interfere with the safety of the patient or evaluation of the study objectives

PRIOR CONCURRENT THERAPY:

* Not specified
The Survival Outcome of Adjuvant Chemotherapy for Stage I Pancreatic Cancer

This study aimed to evaluate the impact of adjuvant chemotherapy on survival in patients with Stage I pancreatic cancer stratified by pathologic risk factors.


Eligibility Criteria:
Inclusion Criteria: Patients who underwent surgical resection and were pathologically diagnosed as PDAC between 2010 and 2021.

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Exclusion Criteria: Patients with pN1-N2, patients with pT3-T4, patients with distant metastasis, patients who received neoadjuvant therapy, patients with R1 resection, and patients who died due to perioperative mortality within 30 days.

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Genetic Registry for Rheumatoid Arthritis

Many genes are thought to contribute to rheumatoid arthritis (RA). This study will attempt to identify genes that may contribute to RA.

The identification of genes for complex disorders such as RA requires large numbers of genetically informative families. This study enrolls people diagnosed with with RA and their families.

This study will enroll 1000 RA patients and their parents. Participants with RA will be evaluated at his or her doctor's office or other location convenient for the participant. Participants will have a brief phone interview with a study coordinator and a blood sample will be obtained. Disease evaluation will be done at one visit and will include confirmation of diagnosis, a 28 joint count, joint alignment and mobility score (JAMS) and administration of a health assessment questionnaire.

Eligibility Criteria:
Inclusion Criteria:

* Adult onset RA
* Diagnosis of RA made between 18 and 60 years old
* Both parents alive and willing to participate
* Parents may have diagnosis of RA (affected) or be unaffected

Exclusion Criteria:

* Inflammatory bowel disease
* Lupus
* Psoriatic arthritis
Hypotensive Anesthesia for Orthognathic Surgery

The overall objective of this double blinded, randomized controlled trial (RCT) is to compare specific outcomes of three medications (Dexmedetomidine, Nicardipine, and Labetalol) which are routinely used to lower blood pressure used during general anesthesia for orthognathic (jaw) surgery. The outcome measures for the study will be surgical field visibility, estimated blood loss, hemodynamic parameters, operation time, and adverse events.

The specific objectives of this study are to compare:

1. Dexmedetomidine, Nicardipine, and Labetalol's effect on the quality of the surgical field. (Primary Outcome)
2. Dexmedetomidine, Nicardipine, and Labetalol's effect on estimated blood loss.
3. Dexmedetomidine, Nicardipine, and Labetalol's effect on hemodynamic parameters including systolic blood pressure, mean arterial pressure, and heart rate.
4. Dexmedetomidine, Nicardipine, and Labetalol's effect on operation time.
5. Dexmedetomidine, Nicardipine, and Labetalol's effect on adverse events.

The investigators will evaluate healthy adult male and female patients who require jaw surgery at Boston Medical Center. The anticipated 90 participants will be randomized into three groups: ) A Labetalol group in which the patients receive hypotensive anesthesia with the aid of labetalol, 2) A Nicardipine group in which the patients receive hypotensive anesthesia with the aid of nicardipine, and 3) A Dexmedetomidine group in which the patients receive hypotensive anesthesia with the aid of dexmedetomidine.

The time it will take for each individual participant ranges from 1-3 months. This time includes the pre-operative visit, the surgical procedure, a 1-week post-operation visit, and then followed for 30 days post-operatively after which the patient's participation in the study will conclude.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients undergoing orthognathic surgery \[Le Fort I, Surgically Assisted Rapid Palatal Expansion (SARPE), Bilateral Sagittal Split Osteotomy (BSSO), or a combination these surgeries\] at Boston Medical Center with Dr. Mehra
* Healthy, American Society of Anesthesiologists (ASA) physical status classification system I or II

Exclusion Criteria:

* Patients on a home beta blocker
* Patients on home calcium channel blocker
* Patients on home alpha 2 agonists
* Patients with an allergy to one or more of the intervention medications
* Does not speak English
* Pregnant patients (this is assessed day of surgery per standard care with a urine pregnancy test)
* Patients who have contraindications to induced hypotensive anesthesia
Evaluation of Health Education Theater

This study evaluates the feasibility and the potential positive health impacts of a novel "health education theater," which will task participants of a health education program to create an original 10-minute theater that is required to use the health guidelines about physical activity and diet/nutrition. The outcomes include the changes in (a) knowledge about these guidelines, (b) compliance to these guidelines, (c) health related quality of life, and (d) self-perception well-being measures such as self-esteem and self-efficacy.


Eligibility Criteria:
Inclusion Criteria:

* University of California (UC) Davis students who register for the course entitled " Health Education Theater," to be held during the 2019 Spring Quarter, i.e., from April 2019 to June 2019.

Exclusion Criteria:

* Adults unable to consent
* Individuals who are not yet adults (infants, children, teenagers)
* Prisoners
* Individuals who are not compliant to this project's guideline of health limitations. Under this project guideline, absences due to health limitations are not expected to exceed 3 days maximum in addition to standard class policy during the quarter. As long as a subject is compliant to this project guideline and the additional accommodations authorized by the UC Davis Student Disability Center (SDC), any student (including a pregnant woman student and a student with a disability) can participate in this study.
Evaluation of Sexual Functions With Validated Measurement Scale After Transvaginal Extraction of Tissue by Laparoscopic Surgery With Uterus Preservation (FSF-TVE)

The retrieval of tissues removed by laparoscopic surgery larger than trocars caliber, with preservation of the uterus, required for a long time intraperitoneal electromechanical morcellation, until the Food and Drug Administration expressed concern about intraperitoneal dissemination of malignant cells, in the case of unrecognized sarcomas.

Transvaginal contained tissue extraction via a posterior colpotomy and manual morcellation in the bag is one of the possible alternatives.

Available data suggested the effectiveness and safety of this technique, also in terms of time and costs, without a increased risk intra and post-operative complications.

The available evidence shows the lack of sequelae also on fertility and sexual function.

Nevertheless, sexual function has never been evaluated qualitatively in all its aspects nor quantitatively with a validated measurement scale, which can allow us to inform the consequences on the real risk of implications on sexual function determined by vaginal incision. In view of these elements, the aim of the investigator's study is to compare patients in whom laparoscopic tissue removal has been carried out with posterior colpotomy or without it with removal from the trocars.


Eligibility Criteria:
Inclusion Criteria:

* Benign uterine and adnexal pathology
* Preservation of the uterus
* Sexually active women
* Premenopausal women

Exclusion Criteria:

* Pelvic inflammatory disease, endometriosis and pre-existing dyspareunia or chronic pelvic pain of any origin
* Previous Hysterectomy
* Other gynecological and non-gynecological (chronic endocrine, metabolic, autoimmune, neoplastic diseases, psychopathology, mental and sensory-motor disabilities) comorbidities
* Language barrier
Standardized Home Exercise Prescription Education

This project will encompass an evaluation of the educational value of having evidence based home exercise protocols available for family medicine residents in regard to the prescription of home exercise treatment for common musculoskeletal conditions. Investigators will be evaluating resident knowledge on home exercise prescription as well as their level of comfort in educating their patients before and after a series of didactic sessions and implementation of exercise protocols.

This study aims to fill the gap in this area of the literature pertaining to home exercise prescription. The justification of this study's scientific merit comes from the lack of literature and the need for research in this area. There have been multiple studies that have shown different exercise modality treatments for common musculoskeletal (MSK) complaints significantly improve both disability and overall quality of life. Despite the evidence of the short and long term effectiveness of exercise based therapies, there is a general lack of confidence of residents in prescribing and teaching patients rehab exercises.Additionally, many of the patients seen in the University of Florida (UF) Family medicine residency program cannot afford or do not have time to attend physical therapist led rehab sessions. This makes physician led education and the ability of prescribing exercise based treatments for musculoskeletal (MSK) complaints a very important component of patient care.

Eligibility Criteria:
Inclusion Criteria:

* Resident of the Family Medicine Department at the University of Florida.

Exclusion Criteria:

* None
TrasGEX™: Phase 1 Study in Cancer Patients

This was a prospective, open label, multicenter study evaluating the safety, tolerability and pharmacokinetics of TrasGEX™ after intravenous administration in patients with HER-2 positive cancers. The effect of TrasGEX™ on the development of anti-drug antibodies and on tumour response was also evaluated.

Adult patients with advanced and/or metastatic HER2-positive cancer who were resistant to or for whom there was no standard anti-tumor therapy available at the time of enrollment and who had an estimated life expectancy of at least 3 months were eligible for participation in this study.

Patients were to receive the study drug until disease progression (clinical or radiologic), unacceptable toxicity, or any other reason leading to termination of study treatment.

Dose-escalation was performed in 3 to 6-patient cohorts.

Eligibility Criteria:
Main Inclusion Criteria:

1. Signed written informed consent granted prior to initiation of any study-specific procedures;
2. Male or female patients of ≥18 years of age;
3. ERBB2 (HER-2) gene amplification or ERBB2 overexpression
4. Histologically or cytologically confirmed cancer, either locally advanced or metastatic;
5. No anti-tumor therapy of proven benefit available at study enrollment;
6. Life expectancy of \>=3 months;
7. Eastern Cooperative Oncology Group (ECOG) performance status (PS) \<=2;
8. Male or female patients of child-producing potential must agree to use contraceptive measures or oral contraception during the study and for 28 days after the last dose of TrasGEX™;
9. Female patients of childbearing potential must have a negative serum pregnancy test within 7 days prior to the first dose of TrasGEX™;

and

Main Exclusion Criteria:

1. Anti-cancer chemotherapy, radiotherapy, immunotherapy, or investigational agents within 4 weeks of the first dose of TrasGEX™;
2. Major surgery within four weeks of the first dose of TrasGEX™;
3. Newly diagnosed brain metastases, metastases that have been documented to be stable for \<3 months, or metastases for which systemic corticosteroids are required;
4. History of allergic reactions attributed to compounds of similar chemical or biologic composition as TrasGEX™;
5. History of myocardial infarction within 12 months of the administration of the first dose of TrasGEX™;
6. History of congestive heart failure defined as Class II to IV per New York Heart Association classification within 12 months of the administration of the first dose of TrasGEX™;
7. Left ventricular ejection fraction \<50%;
8. Previous malignancy other than the current diagnosis within 5 years of the first dose of TrasGEX™;
9. Pregnancy or lactation; and
10. Concurrent uncontrolled significant illness
Incretin-based Therapy in Preclinical Type 1 Diabetes in Adults

The main objectives of the trial are to study whether daily treatment with liraglutide improves insulin secretion and glucose metabolism, and whether liraglutide treatment is tolerable and safe in subjects with preclinical type 1 diabetes aged 18-30 years.


Eligibility Criteria:
Inclusion Criteria:

* 18-30 years of age
* positive for at least 2 biochemical islet autoantibodies
* have normal glucose tolerance in OGTT
* are not pregnant

Exclusion Criteria:

* allergic to liraglutide or other ingredients of Victoza®
* Type 1 diabetes
* diabetic ketoacidosis
* previous treatment in the last three months with any antidiabetic medication
* impaired liver or kidney function or on dialysis
* severe heart failure
* severe stomach or gut problem resulting in gastroparesis, or inflammatory bowel disease
* past or current history of pancreatitis
* serum calcitonin value above normal (\>50 ng/l or ≥3.4pmol/l)
* presence of any chronic metabolic, hematologic or malignant disease
* obesity BMI ≥30
* pregnant females and females of childbearing potential who are not using adequate contraceptive methods.
* breast-feeding
FARD (RaDiCo Cohort) (RaDiCo-FARD)

The goal of this observational study is to conduct a prospective assessment of the individual Burden of 9 rare skin diseases to assess disability in the broadest sense of the term (psychological, social, economic and physical) for patients and/or families.

Two types of indicators will be used to reach this objective :

1. an individual burden score calculated based on a burden questionnaire created specifically, approved and designed to understand the tendency to changes in care and lifestyles. The burden questionnaire should be used by patients and/or their family themselves in self-assessment.
2. a descriptive analysis of all resources (medical and non-medical) used by the family unit to manage the disease.


Eligibility Criteria:
Inclusion criteria :

* adults or children with a confirmed diagnosis of one of the 9 following rare skin disease: Inherited epidermolysis bullosa, Ichthyosis, Ectodermal dysplasia, Incontinetia Pigmenti, Neurofibromatosis type 1, Albinism, Pemphigus, Mucous membrane pemphigoid or Palmoplantar keratoderma.
* prevalent or incident and followed in one the reference/competence centers of the FIMARAD healthcare network,
* able to understand a survey (for child, survey should be understood by parents),
* having given their signed consent to participate to the cohort RaDiCo-FARD (parents' consent for child).

Non-inclusion criteria :

* Patients, for whom regular care follow-up is not feasible with the FIMARAD healthcare network sites,
* Unconfirmed diagnosis (according to criteria for each disease),
* Patients (and/or parents) not able to understand a survey
* Patients (and/or parents) not having given their signed consent to participate to the study
Cervical Cancer Screening Intervention Among Korean American Women

This is a randomized trial to evaluate the effects of a community-based intervention on increasing cervical cancer screening rates in underserved Korean American women. Due to the multiple factors that contribute to screening uptake, an educational program customized to Korean culture combined with navigation assistance may be effective in increasing the number of Korean American women who can access cervical cancer screening.

PRIMARY OBJECTIVES:

I. To evaluate the efficacy of a culturally-appropriate educational intervention compared to a general cancer health education program in increasing cervical cancer screening among Korean American women.

SECONDARY OBJECTIVES:

I. To examine the effects of a culturally-appropriate intervention on women's knowledge, psychosocial beliefs about cervical cancer and screening, and barriers to screening compared to a general cancer health education program.

II. To examine the extent to which changes in knowledge, psychosocial beliefs, and barriers mediate the effects of the intervention on screening behavior.

OUTLINE: Participants are randomized to 1 of 2 arms.

ARM I (INTERVENTION CONDITION): Participants undergo a culturally appropriate, church-based intervention comprised of four components: 2-hour small group education sessions delivered at church sites by professional, bilingual community health educators (CHEs) that include culturally appropriate visual aids and print materials in Korean; navigation assistance, including language services, appointment scheduling, and transportation assistance from CHEs and church health workers (CHWs); referrals to Pap test sites; and a 6-month reminder letter for screening.

ARM II (CONTROL CONDITION): Participants undergo 2-hour general health and cancer education by bilingual CHEs, which covers nutrition, regular check-ups, tobacco use, and cancer screening. Participants also receive pre-existing written material produced by the American Cancer Society (ACS), National Institutes of Health (NIH), and Centers for Disease Control (CDC)., and are advised to seek regular preventive health services.

After completion of study, participants are followed up post-intervention and at 12 months.

Eligibility Criteria:
Inclusion Criteria:

* Self-identified Korean ethnicity
* Possessing a functional telephone in the home or on person
* Anticipated presence in this geographic region for a period of one year

Exclusion Criteria:

* A current diagnosis of cervical cancer
* Have had a Pap test within the past 12 months
* Are currently adherent to doctor recommended screening interval
Virtual Reality Stimulation to Enhance Cognitive Function of Intensive Care Unit Patients

An observational study will be conducted in the ICU (Intensive care unit) including patients with heart surgery (\< 5 days) and prolonged ICU stay (\> 5 days). Patients will receive 5 min Virtual reality stimulation per day. A modified version of the Oculus Rift VR glasses (Facebook inc., USA) with stereoscopic vision and stereo sound will be used to present the virtual world to patients. An integrated eye tracker will measure oculomotor responses that will be synchronized with the physiological data recording. All participants will undergo neuropsychological testing after ICU stay, and after a three-months follow-up. Quality of life prior to the ICU stay will be enquired from relatives. Main outcome variable is the explorative behaviour (attention). Secondary outcomes are the quality of life and cognitive functioning.


Eligibility Criteria:
Inclusion Criteria:

* Age \> =18
* Speak German or French
* Are able to participate the follow up measurements
* Written informed consent

Exclusion Criteria:

* Visual impairments
* Cognitive impairments
* Cognitive impairments
* Craniocerebral injury before admitting the ICU
* Already admitted the intensive care unit (last year) or at reentry
* Psychotic disorders
Human Breast Milk's Role in Food Allergy Development

The goal of this prospective cohort pilot study is to learn about food allergens being passed on in breast milk to breast feeding infants.

The main question\[s\] it aims to answer are:

* Will major allergens for milk, egg, and peanut be passed on to infants in breast milk?
* Will the infants become sensitized to and develop an allergy to the food allergens found in breast milk?
* Will early introduction interventions prevent the development of these food allergies?

Participants will

* provide breast milk sample (s) for testing for food allergens
* Infants will be tested for sensitization via skin prick and blood testing
* Infants will be challenge with suspected foods to determine allergy and undergo early introduction procedures

Recruitment of subjects will be open enrollment pregnant or post-partum women with a personal history of atopic disease such as allergic rhinitis/conjunctivitis, asthma, atopic dermatitis (eczema), and/or food allergy who are exclusively breastfeeding.

Mothers will provide a breastmilk sample(s) for testing of allergens to milk, egg, and wheat. Prior to the introduction of solid foods, infants will need to be tested for sensitization to milk, egg, and wheat via skin prick testing and blood allergy testing.

Infants that are negative for sensitization will undergo introduction of these foods per standard practice. Infants that are positive for sensitization will undergo an office food challenge for those foods that they are sensitized to. A positive food challenge is diagnostic for a food allergy and they will be managed according to standard practice. A negative food challenge means that they are not allergic, and they will undergo early introduction protocols and monitored to continued tolerance.

Eligibility Criteria:
Inclusion Criteria:

1. Pregnant or post-partum females who plan to exclusively breastfeed and their infants who have completed at least 37 weeks of gestation

   1. These are vulnerable populations
   2. Our study involves breastmilk analysis, which we need postpartum mothers to supply.
   3. (Parent) Testing will be done solely on breastmilk samples, with only potential dietary intervention done to the parent postpartum depending on the outcomes of the infant and breastmilk.
   4. (Infant) In order to determine if allergens in breastmilk play a role in food allergen sensitization, we need to test the infants prior to the introduction of solid foods.
2. Personal history of atopic disease such as allergic rhinitis/conjunctivitis, asthma, food allergies, and atopic dermatitis
3. Maternal diet must include hen's egg, cow's milk, and wheat products.

Exclusion Criteria:

1. No maternal history of atopic disease
2. Exclusive formula feeding
3. Maternal diet devoid of hen's egg, cow's milk, or wheat, for example, vegan diets and persons with gluten sensitivity.