cyrilzakka/clinical-trials huggingface dataset:
Impact of Bariatric Surgery in Patients With Morbid Obesity

The main objective is to compare the prevalence of anal incontinence (AI) before and after bariatric surgery in obese patients.

Inclusion: Patients who are scheduled for a bariatric surgical procedure after a multidisciplinary evaluation for about 1 year (following french national recommendations).

Primary objective: After inclusion, all patients will fill in a specific self-questionnaire evaluating AI (PFDI-20 score) before surgery and at 6 months after surgery.

Investigators will evaluate the prevalence of anal incontinence before and at 6months after surgery using this PFDI- 20 score.

In those patients with preoperative anal incontinence (only in patients with 3 positive answers to question n°9,10, and 11 of PFDI-20 score self-questionnaire), a pelvic MRI will be performed before and at 6 months after surgery. Consequently, no further imaging exam will be performed in patients without preoperative anal incontinence (less than 3 positive answers to question n°9,10, and 11),

Secondary objectives:

* to evaluate the AI severity variation before and at 6 months after bariatric surgery regarding the percentage of postoperative weight loss.
* to compare the quality of life (PFIQ-7 score) related to AI day before and at 6 months after bariatric surgery.

This study is proposed to all obese patients evaluated for potential bariatric surgery during a multidisciplinary evaluation for about 1 year following current french national recommendations.

Demographics are collected from medical records (age, sex, weight, height, diabetes, sleep apnea syndrome, hypertension, lipid disorders, distal neuropathy, depression, number of pregnancies, history of vaginal delivery, traumatic delivery, caesarean section, hysterectomy, urinary incontinence surgery, proctologic surgery, presence of rectal prolapse (operated or not), cholecystectomy, digestive resection, menopause, history of urinary or fecal or gaseous leakage, current treatments, tobacco consumption, diet.

Data are collected by self-questionnaire to all included patient during the preoperative consultation (about 6 weeks before bariatric surgery) and during the 6-months postoperative clinical visit scheduled during the regular follow-up.

Eligibility Criteria:
Inclusion Criteria:

* BMI\>40 kg/m2
* BMI\> 35 kg/m2 with comorbidity ( high blood pressure, diabetes, dyslipidemia, sleep apnea syndrome)

Exclusion Criteria:

* anal incontinence due to chronic diarrhea
* transit constipation
* peripheral neuropathy (diabetes ...)
* patient opposition
* any previous bariatric surgical procedure
* any pelvic surgical procedure performed during the study period (between preoperative and postoperative period at 6 months)
Study of the Impact of Welding Fumes on the Arterial System : RISCAS Study

Metals and oxydes are found in welding fumes and are thought to participate in increasing cardiovascular risk in exposed workers. Investigators aimed to evaluate the impact of this occupational exposure on cardiovascular system in a highly exposed population, ship repairing welders and to compare this population to paired controls.

In an exposed-non-exposed study, investigators will include 30 welders and 30 airport runway agents for control. As part of cardiovascular independent risk factors, microvascular endothelial function will be evaluated directly by laser Doppler flowmetry. Blood samples will be also collected and circulating markers of endothelial function (VW factor, E-selectin, VCAM, ICAM, circulating DNA), inflammation (CRP, IL-1β, IL-8, TNFα, IL-10), platelet activation (procoagulant microparticles, thrombin generation, fibin monomer) will be measured. A complete clinical and functional cardiovascular status will be documented in every participant.

Eligibility Criteria:
Inclusion Criteria:

* Male or Female ≥ 18 years
* Employee performing welding or airport operations
* free, informed and written consent
* Being affiliated to a social security system

Exclusion Criteria:

* Taking cardiovascular medications which modify endothelial function and / or coagulation (antiplatelet, antihypertensive, cardiotropic).
* People with a history of ischemic cardiovascular disease, thrombotic disease, chronic inflammatory disease
* Pregnant women
* People with health status would be likely, in the baseline state, to have parameters studied in the study disrupted.
A Clinical Investigation of the Decoria® Aesthetic Group (DAG) for Correction of Nasolabial Folds (NLF)

Decoria intense is a class III medical device and is CE-marked and has been on the market since 2014. Decoria intense is a hyaluronic acid filler that will be used according to intended use for correction of nasolabial folds.

According to the new MDR in EU this clinical investigation will confirm efficacy and safety of Decoria intense.

The plan is to recruit 80 subjects to receive 64 evaluable subjects during 6 months recruitment.

The clinical investigation contains 5 visits and the total time per subject is 12 months. All subjects will receive treatment at Visit 1 with the option to receive a touch-up treatment at Visit 2. Evaluation of the nasolabial folds will be performed by PI using the Wrinkle Severity Rating Scale (WSRS)


Eligibility Criteria:
Inclusion Criteria:

1. Male or Female, ≥18 years of age, of all weight spans, desiring correction of their nasolabial folds.
2. The subject is legally competent, has been informed of the nature, the scope and the relevance of the study, voluntarily agrees to participation and the study's provisions, and has duly signed the Informed Consent Form (ICF).
3. The subject has nasolabial folds considered at least moderate (grade 3) according to the Wrinkle Severity Rating Scale (WSRS), as assessed by the Principal Investigator.

Exclusion Criteria:

1. Pregnant or lactating females.
2. Any previous hypersensitivity reaction to any constituent of the Investigational medical device (IMD) or to local anaesthetic products.
3. Any acute or chronic skin disease or inflammation (such as pimples, rashes or hives) within or close to the area selected for correction.
4. Any bleeding disorder or treatment with thrombolytics or anticoagulants.
5. Any treatment with interferon and ribavirin.
6. Any vaccine taken within 2 weeks prior to the treatment visit.
7. Any other intradermal injection, such as fillers or toxins, received in the same injection area within 6 months of the Screening and Treatment visit (Visit 1).
8. Participation in a clinical investigation study that may affect the safety or performance of this investigation, within one year of enrolment, or planned participation in such investigation at any time during this clinical investigation, as judged by the Principal Investigator.
9. Any other condition or treatment making the subject unsuitable for participation in the clinical investigation, as judged by the Principal Investigator.
10. Employees of the study site or the sponsor directly involved with the conduct of the investigation, or immediate family members of any such individuals.
A Study Investigating the Clinical Parameters Associated With the Use of Ryzodeg® (Insulin Degludec/Insulin Aspart) in a Real-world Adult Population With Type 2 Diabetes in South Korea

This is a non-interventional (observational), retrospective medical record review study collecting data reported in medical records of patients with T2D (Type 2 Diabetes ) who were treated with any basal-insulin or premix-insulin (plus/minus OAD (Oral Antidiabetic Drug)) for at least 26 weeks prior to switching to Ryzodeg® and treated for at least 26 weeks after switching to Ryzodeg® (plus/minus OAD).

All patients have been treated at the discretion of the treating physician in accordance with the Ryzodeg® label in South Korea.


Eligibility Criteria:
Inclusion Criteria:

* Male or female, age above or equal to 19 years at the time of Ryzodeg® initiation
* Type 2 diabetes mellitus patients
* Treated with any basal-insulin (plus/minus OAD (Oral Antidiabetic Drug)) or premix-insulin (plus/minus OAD) for at least 26 weeks prior to switching to Ryzodeg®
* Treated with Ryzodeg® (plus/minus OAD) for at least 26 weeks after switch from any basal insulin (plus/minus OAD) or premix insulin (plus/minus OAD)
* At least more than once documented medical visit for 26weeks (plus/minus 6 weeks) after Ryzodeg® initiation
* Minimum available data : age, type of diabetes at the time of Ryzodeg® initiation, HbA1c \[Three values: most recent value within 26 weeks (plus/minus 6 weeks) prior to Ryzodeg® initiation, a value of Ryzodeg® initiation date (plus/minus 6 week), and a value in the first 26 weeks (plus/minus 6 weeks) after Ryzodeg® initiation\]
* The decision to treat with Ryzodeg® was taken by treating physician independently from decision to include patient in study.

Exclusion Criteria:

* Patients treated with any diabetic investigational drug within 26 weeks before or after the initiation of Ryzodeg®
* Patients switching to Ryzodeg® below 26 weeks prior to the data collection date
* Patients not treated with any basal-insulin or premix-insulin at least 26 weeks prior to receiving Ryzodeg®
* Patients treated by continuous subcutaneous insulin infusion prior to receiving Ryzodeg®
* Pregnancy patient
* Patients not treated with the local licensed Ryzodeg®
Perspective-taking, and Examining the Clinical Trial Informed Consent Process

Background:

- Very few people with cancer participate in clinical trials. Some are uncertain about the treatment, or are afraid of being treated like a guinea pig. They may also feel that they have inadequate information about the trial. One possible way of encouraging people to sign up for clinical trials is to improve the informed consent process. Researchers want to understand how people read and understand informed consent documents.

Objectives:

- To study perspective taking, and to study how people understand the information and enrollment process for a clinical trial.

Eligibility:

- Healthy volunteers at least 18 years of age.

Design:

* This study will require one study visit.
* Participants will watch one of four movie clips. They will be asked to respond to the film by looking at it from the main character s perspective. They will then answer questions about how the clips made them feel.
* Participants will read a sample cancer clinical trial consent form on a computer. The computer will record their eye movements while they read the text. They will then be asked whether they remember the information in the consent form, and whether they would participate in the trial.
* No treatment will be provided as part of this study.

This study aims to examine perspective-taking and emotional states. The study also aims to examine information processing in the context of clinical trial consent forms, perceptions of risk of study side effects, hypothetical intentions to enroll, and satisfaction with the consent review process. Adult human subjects will be randomly assigned to watch a movie and take the main character s. Participants will also be asked to read a consent form for a clinical trial. Finally, they will be asked a series of questions about the consent form. I have also attached changes to the lay summary, which I had previously submitted, just to make sure that you have them.

Eligibility Criteria:
* INCLUSION AND EXCLUSION CRITERIA:

Participants who are currently being treated for cancer will be excluded because their experience of a cancer clinical trial consent form would be qualitatively different from a noncancer patient s experience. Similarly, because individuals who have participated previously in a clinical trial might have a different perspective on participation or let previous experienced bias their perceptions of the hypothetical clinical trial context, we will also exclude individuals who have previously participated in a medical clinical trial.
The Communication of Genetic Risk to Adolescent Daughters of Women With Breast Cancer

The purpose of this study is to first understand how MSKCC Clinical Genetics Service doctors talk to women with breast cancer about any genetic risks they might carry, and if they help women to think about what they might say, in turn, to their relatives, especially their daughters.

A second part of the study asks women for their opinions about when and how their daughters should be told about any genetic risks.

All of this will help us develop teaching methods to help our doctors improve the way they talk about genetic risk when women with breast cancer have adolescent daughters.


Eligibility Criteria:
Inclusion Criteria:

* Women seen in the MSK CGS Service who have a diagnosis of breast cancer or
* a family history of breast cancer and
* have biological daughter(s) in the age range 12-20 years will be eligible to participate in Phase I \& II.
* Women who were consented to Phase I will automatically be eligible for Phase II.

Exclusion Criteria:

* Women seen in the MSK CGS Service will be ineligible if they have no diagnosis of breast cancer and no family history of breast cancer,
* do not have a biological daughter,
* or have a biological daughter fewer than 12 or greater than 20 years(unless they were consented to Phase 1).
* Women will be ineligible if they are not English speaking,
* have intellectual or cognitive impairment,
* or active mental illness rendering them incapable of giving informed consent, such as might occur with active psychosis.
Mucin Balls and Corneal Inflammation Events

The purpose of this study is to determine if the formation of mucin balls is a marker for protection from inflammatory events to the cornea and if mucin balls play a role in protection during extended contact lens wear.


Eligibility Criteria:
Inclusion Criteria:

* At least 18 years
* Free of any active anterior segment disorders that would preclude safe contact lens wear. Active anterior segment disorders and evidence of central microbial keratitis (via a large, \>1mm central deep stromal scar) are not allowed. However, evidence of past Contact Lens-Induces Peripheral Ulcer (CLPU) will be allowed so long as no more then three such scars are detected bilaterally. Evidence of more than 3 CLPU-like scars places excessive risk on the subject for a subsequent Corneal Infiltrate Event (CIE).
* Correctable vision to 20/25 or better in each eye with spectacles. Amblyopia will be excluded.
* Flat and steep corneal curvatures from keratometry readings must be between 39.00 and 48.50 D, respectively.
* Own or agree to purchase a pair of spectacles that can be worn when lenses are removed or in cases of ocular discomfort or emergency.
* Correctable vision to 20/30 or better at distance with dispensed contact lenses.

Exclusion Criteria:

* Use/wear of rigid gas permeable lenses within the last 30 days or Poly (methyl methacrylate) (PMMA) lenses within the last 3 months.
* Immunocompromising disease or insulin dependent diabetes or any other systemic disease that in the investigator's opinion will affect ocular health or increase risk during extended wear.
* Chronic use of systemic corticosteroids (with the exception of corticosteroid inhalers) or any other medication that in the investigator's opinion will affect ocular physiology or study participation.
* Ocular disease or condition such as aphakia, corneal dystrophies, corneal edema, external ocular infection, iritis, or had any anterior segment surgery.
* Use of any ocular medications in the last 2 weeks.
* Less than or equal to grade 2 on any of the slit lamp observations of: upper tarsal papilla, corneal staining, corneal neovascularization, conjunctival injection, and lid erythema or scales.
* Currently pregnant or lactating.
* Smoker
* Swimming routine of more than twice per month.
Long Term Dental Effects in Adolescents Who Were Treated for Cancer in Childhood

The investigators aim is to explore associations between specific types of cancer therapy, age at treatment and the presence of dental abnormalities in adolescence.

The study will help identify unique dental changes, malformations and or missing teeth that appear in adolescence as a secondary complication due to anticancer treatment (chemotherapy and or radiotherapy) given in childhood.

Materials and methods:

* Study Group: 200 patients, at least 12 years old, who were treated for Cancer at the age of 0-10 years old.
* The following data will be collected: Demographic information, Medical Status, Cancer therapy, Intraoral examination, Oral soft and hard tissue condition and radiographic examination.


Eligibility Criteria:
Inclusion Criteria:

* were treated for Cancer at the age of 0-10 years old

Exclusion Criteria:

* None
Host Response to Infection and Treatment in Lymphatic Filarial Disease in India

Patients admitted on this protocol will have, or be suspected of having, one of the lymphatic filarial infections affecting humans. After routine clinical evaluation they will be studied in depth immunologically, and their blood cells and/or serum will be collected to provide reagents (eg., specific antibodies, T cell clones, etc.) that will be used in the laboratory to address the broader questions of immunodiagnosis, immunoregulation, immunopathology and immunoprophylaxis. Careful observations of the patients' clinical and immunologic responses to therapy will be made, as well as long-term follow-up of these changes. It is anticipated both that the patients will receive optimal clinical care for their infections and that the specimens collected from them will prove to be valuable reagents for the laboratory studies of the immunologic responses unique to filarial or other helminthic infections.

This study is designed to determine the presence of and the immune response to filarial and stronglyloides infections in an area endemic for both infections in South India. This study will aim to examine the presence of filarial and Strongyloides stercoralis infection at a community level as well as in hospital settings. After routine clinical evaluation and screening, individuals enrolled in this protocol will be studied in depth immunologically, and their blood cells and/or serum will be collected to address the broader questions of immunodiagnosis, immunoregulation and immunopathology. Careful observations of the individual s clinical and immunologic responses to therapy will be made, as well as long-term follow-up of these changes. In addition to infected individuals, this protocol will also be used to study individuals with filarial pathology and endemic normal individuals. This will enable us to characterize the immunological profiles of infected, uninfected and diseased individuals in an endemic area and provide greater insight into the pathogenesis of lymphatic filarial disease as well as the immunology of strongyloides infection.

Eligibility Criteria:
* INCLUSION CRITERIA:

Age 18-75 years.

Ability to give informed consent.

EXCLUSION CRITERIA:

Pregnant or nursing women will be excluded from the treatment arm of the study.

Less than 18 years of age; greater than 75 years of age.
Safety and Immunogenicity Study of Live Attenuated Vaccine Against Herpes Zoster in Chinese Adults Aged 50 Years and Older

This study evaluates the safety and immunogenicity of live attenuated vaccine in adults aged 50 years and older. Half of participants will receive high doses of the vaccine,while the other half will receive low doses of the vaccine in phase I clinical trial. At the phase II clinical trial, participants will be distributed equally to four groups(low、middle, high doses of the vaccine and placebo).


Eligibility Criteria:
Inclusion Criteria:

* Adults 50 years and older,no vaccine contraindications;
* Subject to comply with the requirements of clinical trial programs;
* No immune globulin vaccination history within a month, no vaccination history within 28 days;
* Axillary temperature ≤37.0 ℃;
* Patients with chronic diseases should be in stable ;
* Postmenopausal or female subjects is no longer the possibility of pregnancy, or subjects pregnancy test was negative and has no pregnancy planner during the clinical trial period;
* The value of blood routine (WBC, RBC, Hb) is normal , or abnormal but meaningless by clinicians judgment ;
* Alanine aminotransferase (ALT) values is normal, or abnormal but meaningless by clinicians judgment ;
* Renal function (serum urea nitrogen) is normal, or abnormal but meaningless by clinicians judgment.

Exclusion Criteria:

* Allergies, seizures, epilepsy, encephalopathy and other medical history or family history of mental illness;
* Subjects who is allergic to any element of the vaccine,and have a history of severe allergy to any vaccine;
* Subjects who is suffering from immune deficiency, receiving immunosuppressive therapy or immunocompromised due to HIV;
* Subjects who had a history of herpes zoster five years ago;
* Varicella or herpes zoster vaccination history;
* Pregnant or lactating women;
* Women who are planning a pregnancy in the near future;
* Any prior administration of vaccine in last 28 days or planned to vaccinate any vaccine during the observation period;
* Suffering from acute febrile diseases, and infectious diseases;
* Thrombocytopenia or other coagulation disorder history, which may cause subcutaneous taboo;
* Accept any other investigational drug users within two months;
* Subjects had high fever (axillary temperature ≥38.0 ℃) in the past three days ;
* The value of blood routine (WBC, RBC, Hb) is abnormal and meaning by clinicians judgment ;
* Alanine aminotransferase (ALT) values is abnormal and meaning by clinicians judgment ;
* Renal function (serum urea nitrogen) is abnormal and meaning by clinicians judgment.
* Blood pressure is abnormal after medication control;
* Known or suspected diseases including: respiratory diseases, acute infection or chronic disease , and cardiovascular disease, kidney disease, skin disorders in the acute phase;
* Any condition that in the opinion of the investigator, may interfere with the evaluation of study objectives.
Clinical Trial of YH32367 in Patients With HER2 Positive Locally Advanced or Metastatic Solid Tumor

This first-in-human study will be counducted to evaluate the safety, tolerability, pharmacokinetics (PK) and anti-tumor activity of YH32367 in Patients with HER2-Positive Locally Advanced or Metastatic Solid Tumors.

YH32367, a novel HER2/4-1BB bispecific antibody (BsAb), simultaneously targets HER2 and h4-1BB and binds to both targets. YH32367 exhibits a strong 4-1BB signal activation as well as blocking of HER2 signaling in HER2-expressing tumor cells. YH32367 stimulates IFN-γ secretion from T cells and thereby induces tumor cells lysis.

This is a Phase 1/2, open-label, multicenter, first-in-human study of YH32367. This 2-part study will include both a Dose Escalation part, to identify the Maximum Tolerated Dose (MTD) and/or two dose levels for RP2D selection, and a Dose Expansion part, to determine RP2D and to confirm the safety, tolerability and efficacy of YH32367 at the RP2D.

Eligibility Criteria:
Inclusion Criteria:

\[Dose Escalation Part\]

* Pathologically confirmed HER2-positive
* Mandatory provision of tumor tissue sample

\[Dose Expansion Part\]

* Patients who have at least one measurable lesion
* Mandatory provision of tumor tissue sample

  1. Cohort 1: Pathologically confirmed HER2-positive biliary tract cancer
  2. Cohort 2: Pathologically confirmed HER2-positive metastatic solid tumor malignancy other than breast and gastric or gastroesophageal junction adenocarcinoma and biliary tract cancer

Exclusion Criteria:

* Uncontrolled central nervous system (CNS) metastases
* Spinal cord compression
* Carcinomatous meningitis
* Acute coronary syndromes
* Heart failure
* Interstitial lung disease (ILD)
* Pneumonitis
* History of a second primary cancer
* Human immunodeficiency virus (HIV)
* Active chronic hepatitis B
* Hepatitis C
* Systemic steroid therapy
* Autoimmune disease