cyrilzakka/clinical-trials huggingface dataset:
Living Conditions and Breast Cancer

The main objective of this study is to estimate of the link (odds ratio) between the precariousness defined by the score SPICE (2 groups: precarious and insecure) and stage at diagnosis (2 groups: CAS: stages 1 or 2 the "good prognosis "versus the witnesses: stage 3 or 4 bad prognosis).

Our secondary objectives include:

* To study the link between cancer stage at diagnosis and diverse parameters describing living conditions
* To construct a new score for social fragility based on new data collected in this study, and to compare this score with the EPICES score
* To study patient quality of life at study baseline

Eligibility Criteria:
Inclusion Criteria (for cases):

* Patient has been correctly informed about the study, and agrees to participate
* The patient must be insured or beneficiary of a health insurance plan
* Incident breast cancer cases (diagnosis based on pathology) excluding sarcoma, classifiable as stage III-IV, surgical cases

Inclusion Criteria (for controls):

* Patient has been correctly informed about the study, and agrees to participate
* The patient must be insured or beneficiary of a health insurance plan
* Incident breast cancer cases (diagnosis based on pathology) excluding sarcoma, classifiable as stage I-II, surgical cases

Exclusion Criteria (for cases and controls):

* The patient is in an exclusion period determined by a previous study
* The patient is under judicial protection, under tutorship or curatorship
* The patient is pregnant, parturient, or breastfeeding
* The patient is opposed to study participation
* Women not able to answer a questionnaire due to language barriers or due to vascular or degenerative cerebral dysfunction
* It is impossible to correctly inform the patient
Comparison of AZD6244 in Combination With Dacarbazine Versus (vs) Dacarbazine Alone in BRAF Mutation Positive Melanoma Patients

To assess the efficacy in terms of overall survival of AZD6244 in combination with dacarbazine, compared with dacarbazine alone, in first line patients with BRAF mutation positive advanced cutaneous or unknown primary melanoma


Eligibility Criteria:
Inclusion Criteria:

* Histological or cytological confirmation of advanced (inoperable stage III and stage IV) cutaneous or unknown primary melanoma
* Tumor sample confirmed as BRAF mutation positive

Exclusion Criteria:

* Diagnosis of uveal or mucosal melanoma
* Any prior Investigational therapy comprising inhibitors of Ras, Raf or MEK
* Having received an investigational drug within 30 days of starting treatment, or have not recovered from side effects of an investigational drug
Metabolic Syndrome and Vitamin D Level in Old People

In 2012, a cross-sectional survey sampling 1,966 community-dwelling old people was conducted. Structurized questionnaires were interviewed face-to-face by well-trained staffs. An overnight fasting blood were obtained for biochemistry parameters.


Eligibility Criteria:
Inclusion Criteria:

* more than 65-year-old

Exclusion Criteria:

* excluding empty houses, death, non-ambulatory subjects (subjects with significant disabilities, such as handicapped cerebral vascular accident, cancerous cachexia, unstable chronic diseases or psychiatric disorders, severe arthritis or inflammatory disease), uncomfortable anorexia by any medications, and non-reachable subjects
Effect of Clarithromycin and Rifampicin on the Pharmacokinetics of XZP-3287 in Healthy Subjects

This is a phase I study to assess the drug-drug interaction of XZP-3287 and Clarithromycin/Rifampicin. The study also evaluates the pharmacokinetic and tolerability of XZP-3287 in healthy subjects.


Eligibility Criteria:
Inclusion Criteria:

1. Healthy male or female subjects aged 18 to 65 years (including 18 and 65);
2. Male body weight ≥50kg, female body weight ≥45kg, body mass index between 18 to 28 kg/m2 (inclusive).
3. No medical history of important primary organ diseases such as nervous system, cardiovascular system, urinary system, digestive system, respiratory system, metabolism and musculoskeletal system.
4. Subjects shall ake effective contraceptive measures voluntarily within 3 months from the date of signing the informed consent form (for women, 2 weeks before trial screening) to the date of the last medication.
5. Willing and able to comply with all scheduled visits, study procedures, and provides written informed consent

Exclusion Criteria:

1. Allergic constitution and those with known allergy to XZP-3287 or similar drugs and excipients
2. Abnormal clinical tests and clinical significance judged by the investigator
3. Frequent use of sedatives, sleeping pills or other addictive drugs within 6 months before enrollment
4. History of drug use, or drug abuse screening positive
5. Those who had smoked more than 5 cigarettes per day on average in the 3 months before the screening period or habitually used nicotine-containing products and were unable to quit during the test period
6. Heavy drinking or regular drinking in the six months preceding the screening period
7. Use of any prescription drug or Chinese herbal medicine within 4 weeks prior to enrollment, or use of any over-the-counter drug, any vitamin product, health care drug within 14 days prior to enrollment;
8. Treatment with an investigational drug within 3 months
9. Participated in blood donation with blood donation volume ≥400 mL or received blood transfusion within 3 months before screening.
10. Had a severe infection, trauma or major surgery within 4 weeks of screening
11. Gastrointestinal disorders causing clinically significant symptoms such as nausea, vomiting, and diarrhea, or malabsorption syndromes
12. Pregnant or lactating women, or subjects cannot take strict contraceptive measures as required.
13. Hepatitis B surface antigen or E antigen, hepatitis C antibody, HIV antibody and syphilis antibody, any of which are positive.
14. Allergic to any food ingredients or has special requirements on diet, cannot follow the unified diet
15. habitual consumption of food or beverage containing methylxanthine, such as tea, coffee, cola, chocolate and so on during the study period
16. habitual consumption of grapefruit juice during the study period
17. have difficulty in blood collection or cannot tolerate vein puncture for blood collection
18. As determined by the investigator, the subject has other factors that are not suitable for the study
Ultrasound-guided Femoral Vein Accessibility, Safety and Time for Atrial Fibrillation Treatment

This study is designed to evaluate the use of real-time ultrasound-guided femoral venipuncture during pulmonary vein isolation for treating atrial fibrillation .

The number of pulmonary vein isolation (PVI) therapy for atrial fibrillation (AF) is increasing. Multiple femoral vein cannulation is mandatory for this procedure. There are mainly two methods to cannulate the femoral vein; by anatomical landmark or by under real-time ultrasound-guided. As high anticoagulant level is required for the procedure, there are 0-13% of vascular access complication.

Real-time ultrasound assistance for central venous catheter cannulation has been proven to reduce complications. In the field of AF treatment, multiple femoral vein cannulation is required as many catheter is required for the procedure and larger sheaths are inserted with a high anticoagulant level during the procedure. In this setting, the use of ultrasound use is not well studied.

The current study is to confirm whether real time ultrasound-guided femoral vein cannulation for PVI can prevent complications, reduce puncture time, puncture attempts and accidental artery puncture compared to conventional anatomical approach. Two seethes for each femoral vein is going to be cannulated.

The study design is a multicenter prospective randomized trial to compare the above safety and efficacy by using the ultrasound-guided and anatomical landmark approach. Also time for cannulation, number of puncture attempts, need of X-ray for cannulation will be analyzed in the setting of patient factors including age, body mass index and sex.

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing pulmonary vein isolation with radiofrequency catheter ablation for atrial fibrillation treatment.

Exclusion Criteria:

* Patients with prior known vascular access problems or priory included to the current study.
Effect of Supplementation With ω-3 Fatty Acids, Vitamin D and Calcium in Patients With Acute Lymphoblastic Leukemia.

The purpose of this study is to evaluate the efficacy of supplementation with Omega 3, Vitamin D and Calcium, in a cohort of children with ALL undergoing treatment and compare changes in the concentrations of biomarkers of bone resorption (TRAP5b, CTX, and RANKL), the RANKL/OPG ratio, and biomarkers of bone formation (BALP, OC, PINP, PICP and OPG) after 6 and 12 weeks of supplementation.

In pediatric hematological patients, the administration of high and prolonged doses of corticosteroids has a negative effect on bone metabolism, causing a significant reduction in bone mineral density (BMD). Maintaining adequate levels of vitamin D (VD) and calcium is crucial for bone health, and deficiencies in these nutrients increase the risk of osteoporosis. Children with acute lymphoblastic leukemia (ALL) have been found to have a high prevalence of VD deficiency. Bone turnover markers (BTMs) are substances produced by osteoblasts and osteoclasts that provide information about the dynamic remodeling of bone. Limited research has investigated the role of BTMs in pediatric ALL patients receiving VD supplementation.

Emerging evidence suggests that long-chain ω-3 polyunsaturated fatty acids (LCPUFA-ω3) play a significant role in bone health. Consumption of eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) may inhibit bone resorption and promote bone formation in humans.

Currently, there are no randomized controlled clinical trials comparing the effects of combined supplementation with LCPUFA-ω3, VD, and calcium on BTMs in children with cancer.

Eligibility Criteria:
Inclusion Criteria:

* Children with acute lymphoblastic leukemia in maintenance
* authorization from both parents or legal guardian for recruiting of the child into the study with consent have been explained
* Must be able to swallow capsules

Exclusion Criteria:

* Patients with acute or chronic renal failure
* Added pathology
* Fish Hypersensitivity
* Down´s Syndrome
Optimal Management of Extreme Obesity and Severe Knee Osteoarthritis Feasibility Trial

Does weight loss surgery in patients with morbid obesity prior to knee replacement surgery improve outcomes from knee replacement surgery

RCT involving patients who have severe knee osteoarthritis and have a body-mass index (BMI; the weight in kilograms divided by the square of the height in meters) of 45 to 60 and are randomly assigned to receive dietary and lifestyle counseling for 9 to 13 months followed by total knee replacement (control arm) or sleeve gastrectomy with dietary and lifestyle counseling for 9 to 13 months followed by total knee replacement (treatment arm).

Eligibility Criteria:
Inclusion Criteria:

severe knee osteoarthritis body-mass index of 45 to 60

Exclusion Criteria:

previous total replacement of the same knee, a need for bilateral total knee replacement, and knee pain during the previous week that the patient rated at higher than 60 mm on a 100-mm visual-analogue scale. Also,prior bariatric or complex foregut surgery, significant cardiovascular, pulmonary, renal, liver, gastrointestinal, psychiatric disorders, pregnancy, malignancy within last 5 years, anemia, coagulopathy requiring anti-coagulation therapy.
Impact of Double-layer Versus Single-layer Uterine Closure Suture in Cesarean Section on the Development of Postoperative Uterine Scar Deficiency

In recent decades, the rate of cesarean section delivery has steadily increased worldwide ranging at 30% of deliveries, thus long-term risks after cesarean section need to be evaluated. Postoperative risks include, among others, uterine scar rupture and placental complications such as placenta previa and accreta- complications, which are possibly associated with uterine scar dehiscence.

The prevalence of lower-segment uterine scar deficiency has previously been described as 63%. One recent systematic review and meta analysis investigated closure techniques of low transverse cesarean. No significant difference in risk of uterine scar defect comparing single layer versus double layer closure could be detected (RR 0.53), whereas in women with single layer closure, a lower residual myo-metrial thickness was observed (-2.6mm). However, the authors do conclude that data is insufficient to determine the risk of uterine rupture, dehiscence or gynecological outcomes due to insufficient power of available studies. A recently published Randomized Controlled Trial concluded that double-layer closure with unlocked first layer showed a better scar healing than locked single layer.

The investigators main objective is to identify if single-layer suture of the uterus during cesarean section results in a higher rate of cesarean scar deficiency than double-layer suture.

Interventions

Single- layer versus double- layer uterine closure Two different techniques of uterine closure in cesarean section will be compared: single- layer versus double- layer continuous uterotomy suture.

Standardized transvaginal sonography

Transvaginal ultrasound examination is carried out by one expert sonographer. The ultrasound machine used for all examinations is GE Voluson E10.

Primary outcome: CS scar deficiency visualized in transvaginal ultrasound at 3 months after CS (yes/no).

Secondary outcome: Myometrial thickness at the site of uterine scar (mm).


Eligibility Criteria:
Inclusion Criteria:

* First cesarean section
* Scheduled cesarean section at Department of Obstetrics and Gynecology, Medical University of Vienna
* Age ≥ 18 years
* Informed Consent
* Cesarean section at ≥ 37+0 weeks of gestation

Exclusion Criteria:

* Previous cesarean section
* Emergency cesarean section
* Cesarean section \< 37+0 weeks of gestation
* Corporal incision during cesarean section
* Diseases which favor wound healing disruptions (e.g. chronic inflammatory diseases)
* Uterine anatomic anomalies
* BMI \> 35kg/m2
* Placenta previa
Genetics of COVID-19 Susceptibility and Manifestations

Background:

Coronavirus 2019 (COVID-19, or SARS-CoV-2) is a serious public health problem, and genetics may play a role in how serious the illness becomes in certain people. Genes are the instructions that our body uses to grow and develop. Variations in our genes can cause medical conditions and may be the reason why some people get sicker than others.

Objective:

This study aims to learn more about the genetic contributions to the severity of COVID-19. We hope to use this information to develop therapies that reduce the severity of COVID-19 symptoms in some people.

Eligibility:

Anyone located in the United States who has tested positive for SARS-CoV-2 infection may be eligible to join (including NIH staff).

Design:

Participants will complete a questionnaire about their health history and COVID-19 symptoms.

Participants will give a blood or saliva sample. It will be about 2 tablespoons of blood, or we will send a saliva collection kit. Researchers will use this blood or saliva sample to study the participant s DNA.

The data about participants genes will be stored in a large database. The database will be shared with other qualified researchers who are trying to learn about COVID-19. Participants names and other personal details will not be shared. Instead, the data will be labeled with a code.

Participants may be contacted by study team members for up to a year after they join the study.

The current SARS-CoV-2 pandemic presents a serious challenge to public health. Individuals infected with SARS-CoV-2 experience extremes in symptomatology ranging from a complete lack of symptoms to rapidly worsening end-stage pulmonary disease. The explanatory mechanism underlying susceptibility to severe disease remains unknown. We hypothesize that underlying genetic factors are at least partially explanatory. We aim to employ a phenotypic extremes approach to rapidly ascertain severely and mildly affected COVID-19 patients for genomic interrogation to identify germline and somatic variants that may play a role in host susceptibility to disease to correlate those phenotypic extremes with genetic variants. We will employ both a rare and common variant approach, using both genome sequencing and SNP chip analysis and B and T cell repertoire interrogation.

Eligibility Criteria:
* INCLUSION CRITERIA
* Cohort 1 (Existing NIH Clinical Center Patient/Participants invited to participate by their NIH study team)
* Cohort 2 (Individuals recruited through NIH Occupational Medicine Services (OMS) patients referred by NIH investigators or other providers; individuals who self-refer)
* Located in the United States
* Positive test for SARS-CoV-2 virus infection
* Age greater than or equal to 3 years old

  * only for participants providing a blood sample

EXCLUSION CRITERIA:

* Individuals for whom we cannot consent for participation in a language offered by our existing interpretation service.
* Weight less than 10 kg\*
Continuation Treatment Protocol for Patient Who Participated in the BIA 9-1067-302 Clinical Trial

The purpose of the study is to extend the use of opicapone 25 or 50mg once per day by subjects who participated in the BIA 9-1067-302 clinical trial according form 4a for additional three years.


Eligibility Criteria:
Inclusion Criteria:

* clinical diagnosis with PD
* subjects who are willing to participate in the trial.
* subjects who participated in the BIA 9-1067-302 clinical trial.

Exclusion Criteria:

* subjects who didn't take part at the BIA 9-1067-302 clinical trial.
Change in C-reactive Protein (CRP) in Men and Women With Sleep Apnea After Continuous Positive Airway Pressure (CPAP)

C-reactive protein (CRP) is directly implicated in atherogenesis and associated cardiovascular morbidity in patients with obstructive sleep apnea (OSA). Effective Continuous Positive Airway Pressure (CPAP) treatment has been shown to gradually decrease CRP levels and thus consequently improve disease-related cardiovascular morbidity. However, the influence of gender on the CRP evolution pattern has never been assessed before. The aim of our study was to investigate possible gender differences in CRP evolution in OSA patients 3 and 6 months after the start of effective CPAP treatment.

OSA is an independent risk factor for a number of cardiovascular diseases. One important possible mechanism underlying cardiovascular disease in patients with OSA is systemic inflammation. CRP, an acute phase reactant secreted by the liver, is one of the most actively studied biomarkers of low-grade inflammation, and numerous studies have shown that higher CRP levels are associated with high mortality and morbidity due to cardiovascular disease in men and women. In patients with OSA, the question as to whether or not CRP levels are elevated is still under debate. Although continuous positive airway pressure (CPAP) is effective in the management of OSA, conflicting data also exist regarding the effects of CPAP on CRP levels. However, none of the existing studies assessed the influence of gender on the CRP evolution pattern. Therefore, the aim of this study was to investigate possible gender differences in CRP evolution in patients with moderate to severe OSA, free of medical comorbidities, 3 and 6 months after the start of effective CPAP treatment.

Eligibility Criteria:
Inclusion Criteria:

* Patients with apnoea-hypopnoea index \>15/h

Exclusion Criteria:

* chronic obstructive pulmonary disease
* diabetes mellitus
* coronary artery disease
* congestive heart failure
* chronic renal failure
* known dyslipidemia
* smoking history
* hypothyroidism
* chronic or recent infectious or inflammatory disease
* use of anti-inflammatory or antibiotic drugs, or statins.
* postmenopausal females on estrogen replacement therapy.
Preview Rapid Strep A Test Method Comparison Study

This study is designed to determine the accuracy of the Preview Rapid Strep A Test compared to a laboratory reference method for Group A Streptococcal infection and to determine the precision of the Preview Rapid Strep A test.


Eligibility Criteria:
Inclusion Criteria:

* Any patient presenting with symptoms of pharyngitis

  * Fever
  * Sore throat
  * Swollen lymph nodes in neck
  * Redness of throat/tonsils
  * White/yellow patches on tonsils
  * Not currently on antibiotics
* ≥3 years or older
* Ability to read, understand and sign a consent form, in English, or for parent(s) to sign an assent form providing permission to include children under the age of 18.

Exclusion Criteria:

* Currently taking antibiotics
* Previously enrolled in this study
Mirena or Conventional Medical Treatment for Menorrhagia

The aim of this prospective, non-interventional post-marketing surveillance study is to obtain data on safety and efficacy of Mirena in treatment of prolonged or heavy menstrual bleeding (Menorrhagia) under daily-life treatment conditions.

It is planned to conduct the study in about 10 countries with a total of 1000 patients. In several countries, a comparator group will also be documented.

For each patient, an initial visit and one to three follow-up visits after about 3, 6 and 12 months will be documented by the treating physician on the case report form. Observations include the patient's demographic parameters (date of birth, height, weight, race and smoking habits), previous contraceptives and menorrhagia treatment, gynaecological history, baseline menstruation, result of insertion, concomitant medications and diseases as well as menorrhagia symptoms. Overall treatment success will be evaluated at the end of treatment including number of weeks until improvement and reduction of menstrual bleeding with respect to duration and severity, and patient's satisfaction.

The "MiCo - Mirena or conventional medical treatment for menorrhagia" study consist of two parts, MiCo Asia-Pacific and MiCo MA0901 (Rest of World).

Data from both parts will be analysed in separate pools as well as in a global pool. The trial alias are IMPACT Nos. 14697, 14536 (NCT01085487).

Eligibility Criteria:
Inclusion Criteria:

* Women between the ages of 18-45 (inclusive) not intending to get pregnant during the next year
* Women complaining of heavy menstrual bleeding over several consecutive cycles
* Women without structural or histological abnormality of the uterus, or with fibroids less than 3 cm in diameter which are causing no distortion of the uterine cavity (eligible for pharmaceutical treatment according to the NICE guideline 2007)
* Informed consent (where required by laws or regulations)

Exclusion Criteria:

* The contraindications and warnings of the respective Summary of Product Characteristics (Mirena, combined oral contraceptives, oral/injectable progestogens, non-steroidal anti-inflammatory drug, or anti-fibrinolytic agent) must be followed.
* Women taking hormone replacement therapy
* Women with symptoms such as intermenstrual or post-coital bleeding, unless an endometrial biopsy has been performed and pathology excluded
* Women with fibroids that are palpable abdominally or who have intra-cavity fibroids and/or whose uterine length as measured at ultrasound or hysteroscopy is greater than 12 cm (NICE guideline 2007)
* Women on anticoagulative therapy or other treatment (including e.g. Copper IUD use) known to cause menorrhagia