cyrilzakka/clinical-trials huggingface dataset:
Signs and Symptoms of Genetic Abnormalities Linked to Inherited Heart Disease

Genetically inherited heart diseases (familial cardiomyopathies) are conditions affecting the heart passed on to family members through abnormalities in genetic information. These conditions are responsible for many heart related deaths and illnesses.

In this study researchers hope to determine the signs and symptoms (clinical correlation) associated with specific genetic abnormalities causing inherited heart diseases.

In order to do this, researchers plan to evaluate patients and family members of patients diagnosed with inherited heart disease. Patients participating in the study will undergo several tests including blood tests, electrocardiograms (EKG), and echocardiograms. Patients may also be asked to undergo an MRI of the heart to provide a clearer picture of it.

Patients participating in this study may not be directly benefited by it. However, information gathered from the study may contribute to the medical care, treatment, and prevention of problems for others in the future.

Familial cardiomyopathy (FC) often demonstrates both non-allelic and allelic genetic heterogeneity. We propose to determine the clinical correlates of specific genetic defects which cause FC by identifying and expanding a set of kindreds with identical and distinct molecular defects.

Eligibility Criteria:
Individuals with cardiomyopathy referred for evaluation to the NIH.
Mutation of BRCA1/2 and Other Potential Genes in Triple-negative Breast Cancer

The study is to determine the prevalence of potential chemo-response related genes mutation in TNBC patients between pCR and SD/PD group, which achieved after NAC; and to evaluate potential relationship between these gene mutations and NAC-response in TNBC patients.Based on the results,we can further characterize TNBC from a phenotypical and molecular perspective, in order to identify potential new target agents and to individualize the treatment.

This is single centre，exploratory，parallel and retrospective study to analysis the mutation and expression of tBRCA1/2 and other potential genes in triple-negative breast cancer. Patients received neoadjuvant chemotherapy with paclitaxel and carboplation are enrolled in this study. The participants are required to have clinical stage II or III breast cancer with a clinical or radiographically measurable residual tumor after core biopsy. We will enroll the patients of pCR or SD/PD, which achieved after complete NAC. Every group will enroll 50 patients. This study is to identify relationship between different gene mutations and expression, which may be targeted with currently available investigational drugs, and chemo-response.

Patients who will fulfil all inclusion/exclusion criteria. We conducted a retrospective chart review of the 100 patients.

Eligibility Criteria:
Inclusion Criteria:

Patients receiving neoadjuvant chemotherapy with paclitaxel and carboplation are enrolled in this study.

* (1) histologically confirmed mainly invasive breast carcinoma
* (2) a unilateral and non-inflammatory tumors
* (3) status of ER, PR and HER-2 are available and negative
* (4) The participants are required to have clinical stage II or III breast cancer with a clinical or radiographically measurable residual tumor after core biopsy.
* (5)patients had pathological evaluation after NAC
* (6) the pathologic tissues are available for immunohistochemistry and next generation sequencing

Exclusion Criteria:

* (1) carcinoma in situ
* (2) received less than 4 cycles neoadjuvant chemotherapy
Stockholm hyperTRIglyceridemia REGister (STRIREG) Study

The STRIREG study is a retrospective longitudinal general population-based register study including all individuals who had had at least one plasma Tg measurement between 1st January 2000 and 31st December 2021 at Karolinska University Laboratory or Unilabs AB in Region Stockholm (population 2.41 million 2021). The exclusion criteria were a lack of a unique Swedish personal identification number (PIN). The index population consisted of 1,460,184 individuals between the age 0 and 107 years. The index population was extended to form the complete cohort (n=3,607,819) by associating the parents and the siblings (n=2,147,635) to the indexes by interlinkage of personal identification numbers via the Multi-Generation register (see below).

The study baseline for the index population was defined as the date for participant's first Tg measurement.

Hypertriglyceridemia (hTG) is associated with atherosclerotic cardiovascular disease, pancreatitis, and non-alcoholic fatty liver disease in large population-based studies. Less is known about the impact on hereditary hTG and cardiometabolic disease status for the development of hTG and its associated cardiometabolic outcomes. hTG remains a target for lipid lowering therapies and with new pharmacological interventions being developed, there is a need to identify patients that will benefit most from treatment with these new medicines.

The population-based observational Stockholm hyperTRIglyceridemia REGister (STRIREG) study include 1,460,184 index individuals that have measured plasma triglycerides in the clinical routine in Region Stockholm, Sweden, between 1st January 2000 and 31st December 2021. The laboratory measurements also included basic haematology, blood lipid panel, liver function tests and HbA1c. Using the Swedish Multi-Generation register, 2,147,635 parents and siblings to the indexes were identified to form the complete study cohort. Laboratory data from participants were combined with data from several national registers that provided information on cause of death, medical diagnoses, dispensed medicines, and socioeconomic factors including country of birth, education level and marital status.

The multigenerational longitudinal STRIREG cohort provides a unique opportunity to investigate different aspects of familial hTG as well as heredity for other metabolic diseases. Important outcome measures include mortality, cardiovascular mortality, major cardiovascular events, development of incident diabetes, and non-alcoholic fatty liver disease. The STRIREG study will provide a deeper understanding of the impact of heredity on hTG and associated cardiometabolic complications.

Eligibility Criteria:
Inclusion Criteria: All individuals who had had at least one plasma Triglyceride measurement between 1st January 2000 and 31st December 2021 at Karolinska University Laboratory or Unilabs AB in Stockholm County Sweden.

Exclusion Criteria: No Swedish social security number.
Conscious Awareness Practice in Adolescents

The aim of this study is to reveal the effect of mindfulness on self-efficacy and risky behaviors in adolescents.

This randomized controlled experimental study was carried out between 18 September and 27 October at Istanbul Bağcılar Necmettin Erbakan Science High School with a total of 60 students (30 experimental group / 30 control group). Research data were collected from the Conscious Awareness-Based Self-Efficacy Scale-Revised (BFÖS-Y), Risky Behaviors Scale (RDS) and Personal Information Form. Ethics committee approval, written institutional permission and written permission from the participants were obtained for the research. In the first week, pre-tests were given to the experimental and control groups, and the experimental group was given 30 minutes of mindfulness training. Mindfulness training continued to be given to the experimental group for the next 5 weeks, and post-tests were given to the experimental and control groups in the last week.

Eligibility Criteria:
Inclusion Criteria:

* Be between the ages of 14 and 18
* Agree to participate in the study
* Being literate and speaking Turkish fluently
* Have communication and understanding skills

Exclusion Criteria:

* Having a physical health problem that may impair group cohesion and integrity
Evaluation of Systemic Microvascular Endothelial Function in Metabolically Healthy Obesity

Obesity is known to be a risk factor for cardiovascular disease (CVD), type 2 diabetes mellitus, gastrointestinal tract disease, respiratory problems (such as obstructive sleep apnea), joint and muscle problems, reproductive disorders, depression and cancer.

However, recently a new classification has emerged about obesity, the metabolically healthy obesity (MHO). According to the definition of the term, MHO represents obesity that occurs segregated from the metabolic syndrome criteria defined by the International Diabetes Federation (IDF). However, as there is still disagreement about the definition of MHO, the cardiovascular risk of these individuals is also uncertain. This phenotype may present as an intermediate risk between metabolically healthy normal-weight individuals and metabolically unhealthy obese individuals (MUO) or as a transition stage of the disease; when evolving to MUO, represents a higher risk of developing CVDs.

The hypothesis of the present study is that obese individuals classified as metabolically healthy have worse vascular endothelial function when compared to non-obese individuals, demonstrating increased cardiovascular risk even in this subgroup considered "low risk". The detection of endothelial dysfunction in metabolically healthy obese may help in the prevention, treatment and follow-up of these individuals, aiming to reduce the development and morbidity and mortality of CVD.

In the present study, the investigators will use a laser-based method for evaluating non-invasive, operator-independent systemic microvascular function that detects microvascular flow in the skin for the evaluation of systemic vascular endothelial function.


Eligibility Criteria:
Inclusion Criteria:

• obese individuals (BMI ≥ 30.0 kg / m2) meeting the criteria for metabolically healthy obesity

Exclusion Criteria:

* Pregnancy or lactation.
* Endocrine disorders except diabetes, cardiovascular disease except systemic arterial hypertension, autoimmune diseases, malignant neoplasms.
Immunoregulation of Periodontal Disease

Our design is to test in hospital practice a selection of immune parameters that could assess the pathophysiology and progression of periodontal lesions.

These parameters will be measured in 25 healthy volunteers and 25 moderate-to severe periodontal disese patients. Phagocytes will be tested phenotypically and functionally, both ex vivo and in vitro.

Eligibility Criteria:
Inclusion Criteria:

* Persons appearing spontaneously at the consultation of parodontologie for parodontale disease,
* persons agreeing to undergo a sampling of blood intended for the search

Exclusion Criteria:

* Presence of a chronic or pointed pathology,
* an age 18-year-old subordinate or 65-year-old superior,
* pregnant women,
Posaconazole as Salvage Therapy for Aspergillus Pulmonary Infection.

Invasive Aspergillus infection (IAI) occasionally occurs in immunocompromised people. Except administrating empirical anti-fungal agent, using objective parameters to support the tentative diagnosis of an IAI in order to make the anti-fungal treatment more specifically is also important. At present, serum galactomannan (GM) test is the less-invasive, non-cultural, and time-saving examination for augmenting a diagnosis of Aspergillosis. It was suggested by Infectious Disease Society of America (IDSA) 2008 as a screening and monitoring tool for Aspergillosis , and the cut-off value was adjusted to 0.5 by USA FDA . However, in clinical practice, GM seems not to have good predicted value even the sensitivity and specificity are declaimed more than 80% . Other controversial issues include the reproducibility of GM5 and the effect of piperacillin-tazobactam or other antibiotics on the accuracy of GM baseline In this study, serum GMs are examined in two conditions, one is collected for establishing a baseline and the other is collected after piperacillin-tazobactam administration. We hope to confirm the validity of GM baseline and the effect of piperacillin-tazobactam on GM value in Taiwan.

We try to enroll patient who are followed in hematology department in TCVGH and are diagnosed as probable pulmonary Aspergillus infection or proven pulmonary Aspergillus infection. If they have poor response to current thought effective agent for pulmonary Aspergillus (eg, amphotericin B, Voriconazole, itraconazole) 2 weeks, then they can choose to receive Posaconazole as salvage therapy in our study. However, our study wants to quantification of therapeutic response, so the enrolled patient should be agree to let us check serum galactomannan level at beginning and per 2 weeks. They also should be receive chest CT in the beginning and in the end of posaconazole treatment. The rule out timing is evaluated by clinical doctors (hematology department) per 2 weeks, if posaconazole has poor effect to their disease, the clinical doctors can decided to terminate posaconazole administration. Another effective agent will be given when posaconazole fails.

Eligibility Criteria:
Inclusion Criteria:

* Taichung Veterans General Hospital Hematology and Oncology patients with pulmonary aspergillosis, the preliminary use of effective anti-Aspergillus drugs (including amphotericin B, itraconazole, or voriconazole) 14 days later, the symptoms worsen or improve, or can not tolerate the side effects.
* The default number of subjects 12.

Exclusion Criteria:

* Children, minors, pregnant women, newborns, prisoners, mental illness, loss of adult decision-making capacity due to illness, the Aboriginal ... and other vulnerable groups, and critically ill patients
An Observational Study of Xeloda (Capecitabine) in Patients With Metastatic Colorectal Cancer (AXIOM)

This prospective observational study will evaluate the safety and efficacy of Xeloda (capecitabine) administered in monotherapy in patients with metastatic colorectal cancer. Patients will be followed until disease progression or unacceptable toxicity occurs.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients, \>/= 18 years of age
* Metastatic colorectal cancer
* Receiving Xeloda according to registered indication

Exclusion Criteria:

* Patients who are not eligible for Xeloda treatment according to the Summary of Product Characteristics
Post Marketing Surveillance for Contac Bien Z in Japan

This is a post-marketing surveillance study on a marketed cetrizine hydrochloride formulation.


Eligibility Criteria:
Inclusion Criteria:

* Male and female participants, between 15-65 years of age, who purchase the marketed cetrizine hydrochloride formulation

Exclusion Criteria:

* Who have ever experienced allergic symptoms by taking this medication or any component of this medication, piperazine derivative (including levocetirizine, hydroxizine)
* Those who have been under 15en diagnosed with kidney disease
* Children under 15 years of age
A Study to Evaluate the Utilization, Effectiveness, and Quality of Life of Ozanimod in Participants With Ulcerative Colitis

The purpose of this study is to monitor the use, effectiveness and treatment persistence with Ozanimod (Zeposia®) as well as quality of life in participants undergoing treatment for moderate-to-severe ulcerative colitis (UC).


Eligibility Criteria:
Inclusion Criteria:

* Only Ozanimod (Zeposia®) naïve participants can be included into this prospective study
* Participants are suitable for therapy with Ozanimod (Zeposia®) according to the physician's recommendation (made before enrollment and independently of this Non-Interventional Study (NIS))
* Treatment with Ozanimod (Zeposia®) must be in-label and follow the approved Summary of Product Characteristics (SmPC)
* Participants must have confirmed diagnosis of moderate-to-severe Ulcerative Colitis

Exclusion Criteria:

* Participants that have previously been treated with Ozanimod (Zeposia®)
* Participants with mild Ulcerative Colitis (UC)
* Participants with a stoma
* Participants participating in other clinical trials
* Participants with a planned surgical intervention and hospitalization due to UC
* Participants with any contraindications specified in the current version of the SmPC

Other protocol-defined Inclusion/Exclusion Criteria apply.
Antidepressant Use During Pregnancy

This study will determine the safety of antidepressant use during pregnancy for both the mother and the child.

Symptoms of major depressive disorder (MDD) include persistent sad mood, feelings of hopelessness or guilt, decreased energy, irritability, and more. If untreated, MDD can interfere with the ability to work, study, sleep, eat, and enjoy once pleasurable activities. MDD occurs most commonly in females between the ages of 25 and 44. This puts women of childbearing age at a particularly high risk for developing the disorder. However, very little research has been done to determine the safety of antidepressant use during pregnancy and how the medication may affect the baby. This study will determine the safety of antidepressant use during pregnancy for both the mother and the child.

Participants in this observational study will not receive medication or treatment of any kind. Pregnant woman who are already taking medication for depression will be recruited, in addition to pregnant women who are not taking any medication. The participants will first undergo interviews to establish their psychiatric diagnoses. Subsequent interviews will be held to monitor levels of depressive symptoms, exposure to other substances that could potentially harm the fetus, levels of antidepressants in the blood, and dietary intake during pregnancy. Participants will report to the study site for these evaluations at Weeks 20, 30, and 36 of pregnancy. From Week 36 to Week 40, interviews will be conducted over the phone.

At birth, cord blood will be collected and the infant's cries will be recorded. The infant's development will be assessed at 2 weeks and 3, 6 ½, 12, 18, and 24 months postpartum. Mothers who take selective serotonin reuptake inhibitors (SSRIs) and are breastfeeding their children will report to the study site with their children at 1 month postpartum to measure the level of SSRIs in the infant's blood. In addition, digital photographs of the infant's face, profile, hands, and torso will be taken at 2 weeks and 3, 12, and 24 months postpartum. Additional face-only photographs of the infant will be taken at these times and at birth for further in-depth analyses of facial characteristics. Mother-child interactions will be videotaped at all postpartum assessments.

Eligibility Criteria:
Inclusion Criteria:

* Less than 24 weeks pregnant at the time of study entry
* As of 12/1/2005, at significant risk for developing depression or currently taking SSRIs during pregnancy

Exclusion Criteria:

* History of or current psychosis, bipolar disorder, or schizoaffective disorder
* Current substance use disorder
* Any medical condition that may be related to outcomes (such as multiple births or insulin-dependent diabetes)
* Has not attended at least two prenatal visits at the 20-week intake point
Comparison of Factor XII Levels in Gestational Diabetic and Healthy Pregnancies

To compare Factor XII levels in gestational diabetic and healthy pregnancies.

Thirty singleton term pregnant women with a diagnosis of Type I, Type II or gestational diabetes and thirty singleton uncomplicated term healthy pregnant women will be included in our study. Our study will be performed at Istanbul Acibadem Maslak Hospital, Turkey. Blood will be drawn from each patient when they are hospitalized and before they deliver either vaginally or by cesarean section. Blood will be drawn into two citrate tubes, each will contain 4 ml blood. Blood will be transferred to the lab immediately and will be centrifuged. The supernatant will be stored at -80°C. When the anticipated number of samples are completed Factor XII levels will be calculated in each sample.

Eligibility Criteria:
Inclusion Criteria:

* Term pregnancy
* Pregnant patients with a diagnosis of Type I diabetes
* Pregnant patients with a diagnosis of Type II diabetes
* Pregnant patients with a diagnosis of Gestational diabetes
* Non-diabetic pregnancies
* Uncomplicated pregnancies

Exclusion Criteria:

* Preterm pregnancy
* Postterm pregnancy
* Pregnant patients with a diagnosis of systemic diseases other than diabetes
* Complicated pregnancies
A Study of SCTT11 in Healthy Participants and Participants with Thyroid Eye Disease.

Multicentre, Randomized, Double-blinded, Phase I/II Clinical Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Efficacy of SCTT11 in Healthy Participants and Participants with Thyroid Eye Disease


Eligibility Criteria:
Inclusion Criteria for Healthy Participants:

1. Healthy male or female participants aged between18 and 45 inclusive
2. All participants must agree to not fall pregnant and voluntarily use highly effective double method contraception during the study for at least 180 days after the last dose; female participants must have a negative pregnancy test prior to dosing and must not be breastfeeding

Exclusion Criteriafor Healthy Participants:

1.With any other disease or medical condition of clinical significance (e.g., past medical history of chronic hepatic, renal, cardiovascular, neurological/psychiatric, gastrointestinal, respiratory, urological, endocrinological, or other systemic diseases, etc.) as assessed by the investigator.

Inclusion Criteria for TED Participants:

1. Male or female participants aged between 18 and 70 inclusive
2. Participants with moderate-to-severe (has an appreciable impact on daily life and requires intervention, but is not sight-threatening) TED
3. Normal thyroid function, or only mild hyperthyroidism or hypothyroidism (defined as screening free triiodothyronine \[FT3\] and free thyroxine \[FT4\] levels \< 50% above or below the normal limits).

Exclusion Criteria for TED Participants:

1. Decreased best corrected visual acuity of the study eye due to optic neuropathy within 6 months prior to the first dose
2. Corneal abnormalities in study eye with no relief from treatment, as evaluated by the investigator
3. A reduction of ≥2 points in the CAS value or a reduction of ≥2 mm in proptosis in the study eye from the screening assessment period to study baseline period
4. Presence of other ocular conditions that, in the judgement of the investigator, may affect the evaluation of the study results
5. Presence of poorly controlled diabetes mellitus
6. The current presence of other uncontrolled clinical diseases or conditions
7. Abnormalities in any of the following laboratory examinations during the screening phase
8. Poorly controlled hypertension
9. With past medical histories of major surgery and/or trauma within 1 month prior to the first dose
10. With past medical histories of severe allergies, histories of severe drug allergies, known or suspected allergy to any component of this investigational product
11. Vaccination with live or live attenuated vaccine within 1 month prior to the first dose or expected during the study
12. Participation in a clinical study of any drug or device within 3 months prior to the first dose and have used the investigational product or have been treated with the device
13. Pregnant, lactating females; or participants of childbearing potential who are unwilling to use effective contraception during the study and within 180 days after the last dose
14. Other conditions evaluated by the investigator to be unsuitable for enrolment
Early Results Of Coronary Artery Reconstruction For Extensive Coronary Disease

Evaluation of early outcome obtained from coronary reconstruction with or without endarterectomy in extensive diseased coronary arteries


Eligibility Criteria:
Inclusion Criteria:

* Primary elective CABG patients Patch anastomosis more than 2 cm

Exclusion Criteria:

* Patients with combined valvular procedure. Previous open heart surgery Patients with EF \<40%