cyrilzakka/clinical-trials huggingface dataset:
Hereditary Risk Factors for Thyroid Cancer

Thyroid cancers can occur sporadically, but can also be found as tumors that cluster in families with other cancers or genetic syndromes. Researchers are studying thyroid cancer in children and families, with a particular interest in understanding genes and other factors that may put individuals at risk for developing thyroid cancer and thyroid nodules.

* In this study, family and medical history information is collected alongside a blood or saliva sample for genetic studies.
* Individuals with a past or present childhood thyroid cancer/nodule or a thyroid cancer suspected to be inherited in their family are invited to participate.

The purpose of this research study is to learn more about risk factors for inherited thyroid cancer.

The investigators would like to use the participant DNA to look for alterations in genes. The investigator will perform DNA sequencing and other genetic studies to identify errors in the genes that may contribute to the formation of thyroid nodules and cancer.

Eligibility Criteria:
Inclusion Criteria:

* Individual pediatric patient with current or previous known or suspected thyroid cancer or nodule(s).
* Individual adult patient with current or previous known or suspected thyroid cancer or nodule(s) if they come from a family with a high suspicion of hereditary cancer (as below).
* Individuals from families with a high suspicion of hereditary thyroid cancer:

  * Families with a current or previous diagnosis of a thyroid cancer/nodule occurring in childhood (\<18 years old).
  * Families with a high suspicion of hereditary thyroid cancer/nodules other than above to include:

    * Families with thyroid cancer in multiple individuals
    * Families with thyroid cancer and a known genetic syndrome
    * Families with thyroid cancer and a suspected genetic syndrome (e.g. multiple childhood cancers in the family, multiple primary cancers, multiple endocrinopathies, etc.)

Exclusion Criteria:

* Individuals who are unable to give informed consent.
* Individuals who are unable to complete study materials.
Myocardial Perfusion Echocardiography to Detect Human Heart Transplant Rejection

The primary objective of this proposal is to show the efficacy of contrast enhanced ultrasonography in detecting heart transplant rejection in humans. The secondary objective is to demonstrate the efficacy of this technique in generating data which allow for the assessment of short and long term outcomes.


Eligibility Criteria:
Inclusion Criteria:

* All adult subjects (ages 18 to 75) who have undergone heart transplant at Brigham and Women's Hospital

Exclusion Criteria:

* hemodynamic instability (e.g., systolic blood pressure \< 90 mmHg)
* atrial fibrillation with rapid ventricular response (e.g., heart rate \> 120 bpm)
* premature atrial or ventricular complexes of a frequency that will not allow adequate echocardiographic assessment
* poor acoustic windows
* inability to provide informed consent
* any contraindication listed in the Optison package insert (i.e., history of an allergic reaction)
BAY81-8973 Pediatric Safety and Efficacy Trial

The primary objective was to evaluate the safety and efficacy of the treatment with BAY81-8973 for prophylaxis and treatment of breakthrough bleeds in children with severe hemophilia A.

The secondary objectives were

* To assess the safety and efficacy of BAY81-8973 during surgeries.
* To assess incremental recovery of BAY81-8973.
* To assess pharmacokinetic (PK) parameters in a subset of children (Previously treated patients \[PTPs\] and previously untreated patients \[PUPs\] / minimally treated patients \[MTPs\] - participation in PK sampling was voluntary and required consent).


Eligibility Criteria:
Inclusion Criteria:

* Male
* PTPs (previously treated patients): aged \<= 12 years
* PUPs (previously untreated patients) / MTPs (minimally treated patients): aged \< 6 years
* Severe hemophilia A defined as \< 1% FVIII concentration (FVIII:C)
* PTPs: \>= 50 exposure days (EDs) with any FVIII concentrate, no current evidence of inhibitory antibody, and no history of FVIII inhibitor formation
* PUPs: no prior exposure to any FVIII product
* MTPs: having no more than 3 EDs with any FVIII product, no current evidence of inhibitory antibody and no history of FVIII inhibitor formation

Exclusion Criteria:

* With another bleeding disorder that is different from Hemophilia A
* With thrombocytopenia (platelet count \< 100 000/mm\^3)
* Creatinine \> 2x upper limit of normal or Aspartate aminotransferase (AST)/Alanine aminotransferase (ALT) \> 5x upper limit of normal
* Without a negative inhibitor testing at screening (except for PUPs)
* Receiving chemotherapy, immune modulatory drugs, has received another investigational FVIII product within the last month, or received another experimental drug within the last 3 months
* Requires any pre-medication to tolerate FVIII treatment
* Known hypersensitivity to active substance, mouse, or hamster protein
Hip Fracture Prevention Follow-up of Elderly Women in Primary Health Care

Researchers plan a 2022 follow-up of medical records data to investigate fracture incidence and survival for 1248 women, born 1902-1931, in a comparative fracture prevention study with 435 participants from an intervention area and 813 participants from two control areas.

In 2022 researchers want to assess patient records data in intervention and control areas and compare A) Survival B) Risk factors for osteoporotic fractures (wrist, upper arm, vertebral, pelvic, hip) C) physical activity, exercise and drugs that affect fracture risk.

Researchers plan a 2022 follow-up of medical records data to investigate fracture incidence and survival for 1248 women, born 1902-1931, in a comparative fracture prevention study with participants from an intervention area (Vislanda, n=435) and control areas (Emmaboda n=395 and Tingsryd (n=418). Fragility fracture prevalence after 40 years of age was 33% in the 1248 participants with mean age 79 years at baseline 2001.

Participants with 2-4 risk factors (age ≥80, body weight \<60kg, previous fragility fracture or impaired rise-up ability) provided prospective data with FRAMO (FRActure and Mortality) Index as an outcome measure and this index identified 80% of hip, fragility fractures or death within a 2-year follow-up period.

Hip fracture incidence 2004-2005 was not significantly lower in the intervention area but the trend of the odds ratio (0.33) was in line with significantly fewer falls and improved recovery in the intervention area.

In 2022 researchers want to assess patient records data in intervention and control areas and compare A) Survival B) Risk factors for osteoporotic fractures (wrist, upper arm, vertebral, pelvic, hip) C) physical activity, exercise and drugs that affect fracture risk. Data analysis will be blinded for participation in intervention or control groups and statistical methods include Cox regression and Kaplan-Meier's survival analyzes. Birth cohort differences in outcomes will be analysed by using Lexi's diagrams.

Eligibility Criteria:
Inclusion Criteria:

Invitation letter was sent out to all women in three predefined geographical areas of south Sweden born 1902-1931

Exclusion Criteria:

Participants who themselves or their significant others did not read or understand Swedish were excluded.
Interferon Alfa Sensitivity in HIV/HCV Persons Before and After HIV Meds

The chief purpose of this research is to evaluate interferon alpha sensitivity and cell type specific levels of interferon receptor and interferon stimulated genes and proteins in HIV/ HCV (hepatitis C virus) coinfected persons before and after administration of HIV medications (antiretroviral therapy).

We plan to perform liver biopsy by microlaparoscopy on previously untreated HIV/HCV coinfected persons, then give them a dose of peginterferon alfa 2b. HCV and HIV kinetics will be studied. Afterward, HIV will be treated using antiretroviral therapy and the procedure will be repeated.

Eligibility Criteria:
Inclusion Criteria:

* Adult Human
* Able to provide written informed consent
* HIV antibody positive
* HIV viral load positive
* HIV treatment naive
* Hepatitis C antibody positive
* Hepatitis C viral load positive
* Hepatitis C treatment naive
* Approved to take HIV medications for minimum 9 months
* Willing to use contraception, Life expectancy greater than 2 years

Exclusion Criteria:

* Significant opportunistic infections within 12 month
* Hepatitis B positive
* Evidence of liver cirrhosis
* Decompensated liver disease
* Chronic alcohol abuse
* Allergy to raltegravir, tenofovir, and/or emtricitabine
* Active or suspected malignancy
* Sarcoidosis
* Active TB
* Coronary artery disease
* Uncontrolled seizures
* Untreated thyroid disease
* Untreated diabetes
* Weight greater than 125 kg
* Severe depression or severe psychiatric disorder
* Ongoing alcohol or illicit drug use
* Pregnant, nursing, pr planning to become pregnant
* Allergy to interferon
A Clinical Trial of Oral Suberoylanilide Hydroxamic Acid (SAHA) in Patients With Advanced Multiple Myeloma (0683-004)

The purposes of this study are:

* To determine the maximum tolerated dose (MTD) of SAHA administered every 12 hours for 14 consecutive days followed by 7 days of rest during the first two cycles (i.e., first 6 weeks) in patients with advanced multiple myeloma;
* To assess the safety and overall response rate to SAHA in patients with advanced multiple myeloma.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients with refractory or relapsed multiple myeloma, ECOG performance status 0-2 (ECOG)
* Adequate bone marrow reserve
* Adequate hepatic and renal function
* Ability to swallow capsules
* 3 weeks or more from prior chemotherapy and have recovered from prior toxicities

Exclusion Criteria:

* Patients who plan to go for bone marrow transplant within 4 weeks of start of treatment
* Patients with prior treatment with other investigational agents with a similar anti-tumor mechanism
* Patients with other active/uncontrolled clinically significant illnesses
* Pregnant or nursing female patients
Melanoma: Genomic Profiles, Molecular Markers and Therapeutic Implications

The goal of this study is to evaluate the genomic profiles and investigate the prevalence of germ line and pathogenic mutations in Greek population with early and metastatic melanoma and their correlation with the treatment and prognosis of the disease.

In this context, it is aimed to utilize tissue biopsy tests that will focus on specific areas of clinical applications, namely, diagnosis, prognosis and identification of mutations for targeted therapy and assessment of acquiring treatment resistance. Thus, the tissue biopsy Next Generation Sequencing (NGS) panels in development by NIPD Genetics will be used in clinical practice as complementary diagnostics.

For tumor genotyping of the 200 patients with melanoma skin cancer in the present study it will be used the comprehensive tissue biopsy melanoma cancer panel from NIPD Genetics These panels are designed to target clinically actionable and clinically significant mutations that will provide physicians with genetic information regarding a) prediction of the patient's response to targeted therapy, b) prognosis, that is, prediction of clinical outcome, c) diagnosis and molecular classification of melanoma cancer. The panel allows for the detection of single nucleotide (SNVs) and copy number variants (CNVs), as well as gene fusions and indels; it necessitates at least 400ng of appropriate quality DNA template that is achievable from FFPE samples and is validated with molecular standards and controls for the exclusion of artefacts.

Thorough histological evaluation of the Formalin-Fixed-Paraffin-Embedded (FFPE) tumor tissue blocks will be done by an experienced pathologist to evaluate H\&E sections for confirmation of diagnosis, histologic type, grade and tumor cell content (TCC%). DNA isolation will be performed from 10 μm whole sections following manual macro-dissection to enrich samples for tumor DNA, whereby TCC will be assessed as an approximate metric for tumor DNA in the extracted samples, corresponding to tumor nuclei vs. all nuclei in the areas marked for macro-dissection.

A total of 200 patients with melanoma skin cancer are expected to be included in the analysis based on the number of patients registered in the Hellenic Cooperative Oncology Group's (HeCOG's) database along with the ability to achieve precision around the primary and secondary endpoints. Primary endpoint will be the evaluation of the prevalence of mutations, while the secondary endpoint will be the assessment of prognostic significance of mutations with respect to overall survival (OS).

Eligibility Criteria:
Inclusion Criteria:

* Melanoma skin cancer patients
* the ability to achieve FFPE

Exclusion Criteria:

-
Preoperative Edema is a Significant Risk Factor for Post-hepatectomy Complications

Aims: The relationship between bioelectrical impedance analysis (BIA) results and post-hepatectomy complications is unknown. This study aimed to identify the risk factors for post-hepatectomy complications from the BIA results.

Methods: This prospective, observational cohort study reviewed the data of patients who underwent hepatectomy between March 2018 and December 2022. The patients were matched using the following propensity score covariates: biliary enteric anastomosis and major hepatectomy. Risk factors for postoperative complications were investigated in a matched cohort.


Eligibility Criteria:
Inclusion Criteria:

* clinical diagnosis of liver neoplasms

Exclusion Criteria:

* a body weight loss of \>10% during the 6 months before surgery; the presence of distant metastases; or seriously impaired function of vital organs because of respiratory, renal, or heart disease
Blood Pressure Assessment in Waiting Room During Pregnancy

The goal of this observational study is to compare in healthy pregnant women during the first trimester. The main question it aims to answer are:

Accuracy of measuring automatically Blood Pressure (BP) at appointment compared to 24 Hour Ambulatory Blood Pressure Monitor (ABPM).

Participants will be BP measured with homologated device every 3 minutes in waiting room for 20 minutes.

Researchers will compare Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) in clinical visit to see if are comparable to ABPM.

659 pregnant women will be recruitment if they In with SBP readings above 130 mmHg in office or the presence of a risk factor for eclampsia: (hypertensive disease in previous pregnancy, chronic hypertension, chronic renal disease, diabetes mellitus, or autoimmune disease) or any two moderate-risk factors (nulliparity, age ≥40 years, BMI ≥35 kg/m2, family history of PE, or interpregnancy interval \>10 years).

Measured of BP will be performance in waiting room for 20 minutes every 3 minutes and report by an mobile app. After 24h-ABPM device will be implanted. Results of SBP and DBP obtained in office will be compared with 24-h, diurnal and nocturnal SBP/DBP mean.

BP will be measured automatically and repeatedly every 3 minutes in the waiting room for 20 minutes. Subsequently, a SpaceLab ABPM monitor will be implanted. The SBP and DBP results obtained in the waiting room will be compared with the ABPM results.

Clinical data related to eclampsia and maternal and newborn pregnancy outcomes will be collected from all patients.

Eligibility Criteria:
Inclusion Criteria:

Woman during the first 12 weeks of pregnancy Maternal age\>35 Nulliparity Previous history of hypertension Short and long interpregnancy interval Use of assisted reproductive technologies Family history of preeclampsia Obesity. BMI\>30. Hyperglycemia Renal disease

Exclusion Criteria:

Any inability to perform 24-h ambulatory BP measurement
Studying Blood Samples in Young Patients With Cytopenia After a Donor Stem Cell Transplant

RATIONALE: Studying samples of blood from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer.

PURPOSE: This research study is looking at blood samples in young patients with cytopenia after undergoing a donor stem cell transplant.

OBJECTIVES:

Primary

* To study hematopoietic chimerism in whole blood and different cell populations (i.e., CD14, CD15, CD 56, CD3, and CD19) as well as in dendritic cells and regulatory T cells after allogeneic hematopoietic stem cell transplantation with reduced intensity conditioning in patients with refractory cytopenia.
* To compare the results of chimerism obtained with standard short tandem nucleotide polymorphism PCR (sensitivity 1%) with those obtained with single nucleotide polymorphisms PCR (sensitivity 0.1- 0.01%).

Secondary

* To evaluate the relationship between mixed chimerism and hematological engraftment, overall survival, and event-free survival.
* To study the impact of mixed chimerism in plasmacytoid dendritic and regulatory T cells on the incidence of acute and chronic graft-versus-host-disease.

OUTLINE: This is a multicenter study.

Peripheral blood is collected from patients and donors prior to hematopoietic stem cell transplantation (HSCT). Patients also undergo blood sample collection on days 30, 60, 100, and 180 after transplantation. Peripheral blood cells are enriched and separated into lineage-specific subpopulations (i.e., CD3, CD14, CD15, CD19, and CD56) which are then divided equally for either DNA isolation via PCR or for flow cytometry. DNA concentrations in pre-HSCT donor and patient samples and in post-HSCT subpopulation samples are determined using quantitative real-time PCR. Samples are also analyzed for quantification of chimerism and detection of genetic markers via short tandem repeats- and sequence nucleotide polymorphism-based chimerism analyses.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Diagnosed with refractory cytopenia

  * Hypocellular bone marrow and normal karyotype
* Underwent stem cell transplantation (SCT) from an HLA identical (8/8) sibling, an HLA identical (10/10) relative, or an HLA identical or single allelic disparate unrelated donor

  * Received a preparative regimen including either thiotepa or fludarabine phosphate
* Concurrently enrolled on EWOG-MDS-2006

PATIENT CHARACTERISTICS:

* Not specified

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics
Validation of Sexual Function Scale in Female Cancer

To validate the FSFI(Female Sexual Function Index)-K, FSFI - 6 item and Quality of Sexual Function(QSF) version in Korean language of the cancer patients.

Due to the observational nature of the study which aims to evaluate the internal consistency and validity of the Korean version of Questionnaire, formal sample size and power calculations were not performed. When the number of observations (items) per subject ranges from 4 to 6, roughly 152-199 patients are required to show 10% increase in intraclass correlation from baseline ICC of 30% with 85% power and 5% type I error rate. The sample size was determined based on this calculation and practical considerations.

The pilot study will be performed based on 30 people (include reference), and the main study will include 1100 people (considering 10% drop-out from 200 people in each group) cancer type (ovary, cervix, endometrium, and breast) and healthy female. Total 1130 patients.

Eligibility Criteria:
Inclusion Criteria:

* Healthy women

  * Female without history of cancer
  * Cancer free as of the most recent linkage
  * At least 18 years of age
  * Able to speak and read Korean
  * Sexual activity within 3months.
* Female cancer patient

  * History of gynecological or breast cancer
  * At least 18 years of age
  * Able to speak and read Korean
  * Sexual activity within 3months.

Exclusion Criteria:

* Women who are unable to complete the questionnaires.
* Refuse to participate in the survey.
Vision Screening for the Detection of Amblyopia

INTRODUCTION. Amblyopia is defined as the loss of visual acuity (VA) in one or both eyes, without any obvious structural or pathological anomalies. Amblyopic eye should be able to regain some VA if treatment is initiated before the age of seven. It is the leading cause of monocular blindness in the 20- to 70-year olds with prevalence 2-5%. Amblyopia is mainly monocular, hence children are general asymptomatic. VA testing is the only reliable method of detecting amblyopia, and the fourth year of life is considered best for vision screening programs.

AIM: The purpose of the study is to reduce the preventable vision loss. The main goal of the study is to evidence the problem of amblyopia in Zagreb and to release a model for formal, government directed vision-screening program as a Croatian public health policy.

HYPOTHESIS. In Croatia, the prevalence and actual effect of amblyopia and amblyogenic factors, along with treatment efficacy is impossible to quantify, since no population-based studies have been performed regarding this issue. In addition, national screening of preschool children does not exist, while the school-entry screening is prescribed by law. The object of the study is to determine the prevalence of amblyopia in a 4-4.5 year old children of The Town of Zagreb, the efficacy of screening and effectiveness of treatment on reducing amblyopia prevalence. The primary hypothesis is defined: screening of visual acuity monocularly at distance and near in 4-4.5 year old children in Zagreb is effective in detecting amblyopia.

PATIENTS AND METHODS: Monocular vision of about 7000 children/ year aged 4-4.5 for whom both parents gave consent is to be tested with Lea chart at near (40cm) and distance (3m) in the kindergartens of The Town of Zagreb. The criterion for referral to complete ophthalmological examination is VA \<0.8.


Eligibility Criteria:
Inclusion Criteria:

* children in the kindergartens of The Town of Zagreb aged 4-4.5 for whom both parents gave written informed consent

Exclusion Criteria:

* children younger than 4 years and children older than 4.5 years