cyrilzakka/clinical-trials huggingface dataset:
PLAC1 in Reproduction

The PLAC1 gene is a recently described X-linked gene that maps to a region of the X chromosome thought to be important for normal fetal and placental development. Elevated levels of PLAC1 mRNA were detected in preeclampsia and appeared to be directly related to disease severity. PLAC1 may serve as a useful marker of placental dysfunction or threatened pregnancy.

The objective of this study is to measure the prevalence of circulating anti-PLAC1 antibodies in pregnant maternal serum and correlate it with pregnancy outcome. It is likely that women with these antibodies are at higher risk for adverse pregnancy outcomes. Approximately 5% (50 of 1000) will be expected to have anti-PLAC1 antibodies based on previously reported data. The prevalence of these antibodies and their clinical impact on pregnancy outcomes will be determined.

1000 healthy, multiparous and primigravid women will be screened for anti-PLAC1 antibodies at their routine prenatal clinic visits. Subjects will be enrolled at their first clinic visit at USF Health, South Tampa Center, Department of Obstetrics. Blood (1.0 ml) will be obtained as part of the routine blood draw at the time of enrollment. Blood will only be collected when drawn as part of routine laboratory testing as determined by the primary care provider.

Additional blood samples (1.0 ml) will be collected throughout pregnancy at the same time blood is obtained for routine or otherwise clinically indicated laboratory testing. A maximum of 5 samples will be collected through the pregnancy.

Maternal demographic data will be collected and patients will be followed longitudinally to the completion of pregnancy to ascertain their clinical status during pregnancy, onset of premature labor, premature rupture of membranes, delivery date, and gestational age at delivery.


Eligibility Criteria:
Inclusion Criteria:

* Pregnant, primigravid and multigravid women between the ages of 14 and 55, receiving prenatal care at USF Health, STC, Dept. of Obstetrics.

Exclusion Criteria:

* presence of significant cardiac disease
* renal disease
* chronic hypertension
* chromosomal abnormalities
* cancer
Prognostic Significance of Fine-Needle Aspiration Cytology Features in Papillary Thyroid Carcinoma

The purpose of this study is to investigate the relationship between prognosis and fine needle aspiration cytology character of papillary thyroid cancer.

Papillary thyroid carcinoma is the most common thyroid malignancy worldwide. The influence of clinicopathologic features on prognosis has been examined, but the relationship between cytologic features obtained by fine-needle aspiration (FNA) and prognosis has been minimally studied. We retrospectively studied the cytologic features with computerized morphometry in 83 patients with usual-type papillary thyroid cancer and followed them for more than 10 years except for one with metastasis at diagnosis. The cytologic features of FNA and recurrence of cancer were examined statistically.

Eligibility Criteria:
Inclusion Criteria:

* Papillary thyroid cancer diagnosed in NTUH from 1977 to 2000

Exclusion Criteria:

* Patient without complete medical record
TRIGGERING AND PROTECTIVE FACTORS OF BURNOUT IN MEDICAL RESIDENT

Residents and interns are prone to emotional and physical exhaustion, also known as burnout. Burnout has not been studied much in physicians working in lower-middle income countries. We conducted this cross-sectional study at two institutes to determine the burden of burnout among internal medicine residents and to identify triggering and protective factors associated with burnout. An abbreviated version of the Maslach Burnout scale was used to measure burnout, and protective and triggering factors were recorded according to known factors.


Eligibility Criteria:
Inclusion Criteria:

- All residents of the internal medicine program at both institutes

Exclusion Criteria:

* Residents who were part of a flexible training program, working in shifts and those who had done less than six months of training were excluded
Surgical Outcomes in Pediatric Patients With Coarctation and VSD

Recently, a paper was published that compared outcomes of patients requiring repair of aortic coarctation and ventricular septal defect. Some surgeons opt to repair both defects in one surgery while other surgeons do the repair in two separate operations. Recently at Children's Healthcare of Atlanta, we have adopted the practice of correcting both defects during the same operation but through two separate incisions (one on the chest and the other through the ribs on the side. This reduces the amount of time the patient is on the heart-lung bypass machine during surgery. This study is a review of patient charts to compare outcomes of patients who have had surgery to repair their coarctation and VSD during 2002 through 2005.

This study is a retrospective chart review of patients who carry the diagnosis of aortic coarctation and VSD and have had their surgical repair at Children's Healthcare of Atlanta between the dates of January 1, 2002 and December 31, 2005. The data collected will be surgical data such as type of repair, and the time the patient required cross clamp, circulatory arrest and cardiopulmonary bypass while in the operating room for the repair(s). We would also like to gather post-operative information such as time the patient required ventilation, whether they required a re-operation during the same admission, along with intensive care hours and hospital length of stay.

Eligibility Criteria:
Inclusion Criteria:

* diagnosis of coarctation and VSD
* surgical repair at Children's Healthcare of Atlanta between January 1, 2002 and December 31, 2005.

Exclusion Criteria:

* does not have coarctation and VSD
* did not have surgery at Children's Healthcare of Atlanta between January 1, 2002 and December 31, 2005.
Randomized Controlled Trial Methods for Novel Tobacco Products Evaluation

The purpose of this study is to use Randomized Controlled Trial (RCT) methods to examine the influence of novel tobacco products on biomarkers of toxicant exposure and disease risk, reports of adverse events, and concurrent use of other tobacco products. In this case, the novel products are one type of electronic cigarette and an imitation cigarette or cigarette substitute.


Eligibility Criteria:
Inclusion Criteria:

* Age 21-65
* Smoke \>9 cigarettes per day for at least 1 year
* Smoke regular filtered cigarettes or machine-rolled cigarettes with a filter
* CO measurement \>9 ppm at baseline
* No serious quit attempt in the prior 1 month. This includes use of any FDA approved smoking cessation medication (varenicline, bupropion \[used specifically as a quitting aid\], patch, gum, lozenge, inhaler, and nasal spray) in the past 1 month as an indication of treatment seeking.
* Not planning to quit in the next 6 months
* Interested in reducing cigarette consumption
* Willing to attend visits weekly and monthly over a 9-month period (not planning to move, not planning extended vacation, no planned surgeries)
* Read and write in English
* Able to understand and consent

Exclusion Criteria:

* Pregnant and/or nursing women
* Unstable or significant medical condition in the past 12 months (Recent heart attack or some other heart conditions, stroke, severe angina including high blood pressure if systolic \>159 or diastolic \>99 observed during screening).
* Immune system disorders, respiratory diseases (exacerbations of asthma or COPD, require oxygen, require oral prednisone), kidney (dialysis) or liver diseases (cirrhosis), or any medical disorder/medication that may affect participant safety or biomarker data.
* Use of any non-cigarette nicotine delivery product (pipe, cigar, dip, chew, snus, hookah, ECIGs, strips, sticks) in the past 7 days
* Uncontrolled mental illness or substance abuse or inpatient treatment for these in the past 6 months
* History of difficulty providing or unwilling to provide blood samples (fainting, poor veins, anxiety)
* No surgery requiring general anesthesia in the past 6 weeks
* Use of an ECIG for 5 or more days in the past 28 days or any use in the past 7 days
* Use of marijuana or any illicit drug/prescription drugs for non-medical use daily/almost daily, or weekly in the past 3 months per NIDA Quick Screen
* Use of hand-rolled, roll your own cigarettes
* Known allergy to propylene glycol or vegetable glycerin
* Other member of household is currently participating/participated in the study
SYNERGY China: Assess SYNERGY Stent in China

Prospective, multicenter, single-arm study, enroll 100 patients in no more than 10 sites across China, the primary endpoint is Technical success.

The study is To evaluate clinical and peri-procedural angiographic outcomes for the SYNERGYTM MONORAILTM Everolimus-Eluting Platinum Chromium Coronary Stent System in the treatment of subjects with atherosclerotic lesion(s) ≤34 mm in length (by visual estimate) in native coronary arteries ≥2.25 mm to ≤4.0 mm in diameter (by visual estimate).

Eligibility Criteria:
Key Inclusion Criteria:

1. Subject must be at least 18 -75 years of age
2. Subject is eligible for percutaneous coronary intervention (PCI)
3. Target lesion(s) must be located in a native coronary artery with a visually estimated reference vessel diameter (RVD) ≥2.25 mm and ≤4.0 mm, length must be ≤34\* mm (by visual estimate), Target lesion(s) must have visually estimated stenosis ≥50% and \<100% with thrombolysis in Myocardial Infarction (TIMI) flow \>1

Key Exclusion Criteria:

1. Planned PCI (including staged procedures) or CABG after the index procedure
2. Subject with out of range complete blood count (CBC) values that are determined by the study physician to be clinically significant.
3. Subject is on dialysis or has baseline serum creatinine level \>2.0 mg/dL (177µmol/L)
4. Planned treatment of more than 3 lesions, Planned treatment of lesions in more than 2 major epicardial vessels, Planned treatment of a single lesion with more than 1 stent
5. Target lesion(s) is located within 3 mm of the origin of the left anterior descending (LAD) coronary artery or left circumflex (LCx) coronary artery by visual estimate.
6. Target vessel develops a dissection greater than National Heart, Lung, Blood Institute (NHLBI) type C following the pre-dilatation/pre-treatment of the first target lesion
Photodynamic Therapy With Visudyne for Human Retinoblastoma: A Preliminary Study

To study the effectiveness and safety profiles of photodynamic therapy (PDT) for the treatment of human retinoblastoma.

Retinoblastoma is the commonest primary intraocular malignancy in infancy and early childhood. Ophthalmologist are trying to seek other more safe and effective treatment modalities to well control the tumor and preserve the visual function. Photodynamic therapy (PDT) is a potentially therapeutic approach for retinoblastoma which has been underestimated. In this study, we are gonging to investigate the the effectiveness and safety profiles of photodynamic therapy (PDT) for the treatment of human retinoblastoma.

Eligibility Criteria:
Inclusion Criteria:

* patients with intraocular retinoblastoma of Group A-D

Exclusion Criteria:

* (1) patients with intraocular retinoblastoma of group E; (2) patients with extraocular spread; (3); media opacities such as corneal opacity, significant cataract, or vitreous hemorrhage obscuring fundus examination; (4) patients who were allergic to verteporfin or other benzoporphyrin derivatives.
A Study of CC-95251, a Monoclonal Antibody Directed Against SIRPα, in Participants With Advanced Solid and Hematologic Cancers

The purpose of this study is to evaluate the safety, tolerability, and preliminary clinical activity of CC-95251 as a single agent and in combination with cetuximab and rituximab in participants with advanced solid and hematologic cancers.

This is a test.

Eligibility Criteria:
Inclusion Criteria:

* Progressed on standard anticancer therapy or for whom no other approved conventional therapy exists and have histological or cytological confirmation of advanced unresectable solid tumors, advanced unresectable colorectal cancer, or squamous cell carcinoma of the head and neck, or CD20-positive non-Hodgkin's lymphoma, or diffuse large B cell lymphoma, or follicular lymphoma
* Solid tumors must have at least one site of measurable disease as determined by RECIST v1.1
* Eastern cooperative oncology group performance status of 0 or 1

Exclusion Criteria:

* High-grade lymphomas (Burkitt's or lymphoblastic)
* Has cancer with symptomatic central nervous system (CNS) involvement
* History of class III or IV congestive heart failure (CHF) or severe non-ischemic cardiomyopathy, unstable angina, myocardial infarction, or ventricular arrhythmia within the previous 6 months

Other protocol-defined inclusion/exclusion criteria apply
Effectiveness Assessment of Riluzole in the Prevention of Oxaliplatin-induced Peripheral Neuropathy.

It is a phase II trial, randomized, parallel, double blind, multicenter, comparing riluzole versus placebo.

The trial population is composed of patients ≥18 years old that have developed stage II/III colorectal cancer and are eligible for Simplified FOLFOX4 (6-12 cycles) adjuvant chemotherapy.

The primary objective is to assess the preventive efficacy of riluzole on the severity of oxaliplatin-induced peripheral neuropathy during the Simplified FOLFOX4 adjuvant chemotherapy of stage II/III colorectal cancers.


Eligibility Criteria:
Inclusion Criteria:

1. Patients aged ≥ 18 years old,
2. Eligible patient starting adjuvant oxaliplatin-based chemotherapy (6-12 cycles, Simplified FOLFOX4) for stage II/III colorectal cancer,
3. Histological or cytological confirmation of colorectal cancer,
4. Performance status (ECOG) ≤2,
5. Normal hematological function (ANC ≥1.5 x 10⁹/L; platelets count ≥100 x 10⁹/L; hemoglobin ≥9.0 g/dL),
6. Normal hepatic function: total bilirubin ≤1.5 x upper limit of normal (ULN) (unless documented Gilbert's syndrome); aspartate aminotransferase (ASAT) and alanine aminotransferase (ALAT) ≤3 x ULN, and gamma-glutamyltransferase (GGT) ≤3 x ULN,
7. Normal renal function: serum creatinine ≤1.5 x ULN,
8. Normal cardiac function: ECG,
9. Patients affiliated to the French national health insurance,
10. Patient must have signed a written informed consent form prior to any study specific procedures,
11. French language comprehension,
12. Patient is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up.

Exclusion Criteria:

1. Metastatic cancer,
2. Diagnosis of neuropathy,
3. EORTC QLQ-CIPN20 sensory score \>6,
4. Previous neurotoxic chemotherapy treatment,
5. Patients with chronic obstructive pulmonary disease,
6. ALAT/ASAT elevated more than 3 times the normal value,
7. Patients with known allergy or severe hypersensitivity to riluzole or any of the study drug excipients,
8. Dependence on alcohol or drugs,
9. Psychotic disorders,
10. Women pregnant or breastfeeding,
11. Patients undergoing a measure of legal protection (trusteeship, guardianship ...).
Study to Investigate if Sucking a Coldamaris Lozenge Elutes Sufficient Iota-carrageenan to Inactivate Usual Common Cold Viruses

Coldamaris lozenges are a medical device containing 10 mg carrageenan/lozenge. The goal of the study is to determine whether the iota-carrageenan content in the saliva of subjects who sucked Coldamaris® lozenges is sufficient to inhibit the replication of 4 of the most common respiratory viruses causing common cold. At least 29 subjects will be screened, in order to get 24 subjects included.

Coldamaris lozenges are a medical device containing 10 mg carrageenan/lozenge. The goal of the study is to determine whether the iota-carrageenan content in the saliva of subjects who sucked Coldamaris® lozenges is sufficient to inhibit the replication of 4 of the most common respiratory viruses causing common cold. At least 29 subjects will be screened, in order to get 24 subjects included.

The primary objective is whether the mean iota-carrageenan concentration in saliva during sucking an iota-carrageenan containing lozenge reaches published IC90 values for HRV1a and HRV8.

The secondary objectives are whether the mean iota-carrageenan concentration in saliva (µg/ml; base line corrected) during sucking an iota-carrageenan containing lozenge reaches the respective IC90/MIC values (paired t-tests) of the clinical saliva samples for HRV1a, HRV8, hCoV OC43, influenza virus H1N1n and Coxsackie virus A10.

Eligibility Criteria:
Inclusion Criteria:

* personally signed and dated informed consent
* healthy respiratory tract, no acute infection
* age \> 18 years

Exclusion Criteria:

* subjects with signs of an acute respiratory infection
* subjects with a known hypersensitivity to one of the ingredients
* presence of pregnancy confirmed
BEATRIS Study: A Study of Adherence to Bonviva (Ibandronate) Once Monthly in Women With Post-Menopausal Osteoporosis

This 2 arm study will assess the impact of Bone Marker Feedback (BMF), using blood sampling and communication of the results at 2 months, on adherence to monthly Bonviva (150mg po) in women with post-menopausal osteoporosis. Patients will be randomized into either 1) a group which receives bone marker feedback or 2)a group which does not receive feedback on the results. The study will also assess patient satisfaction with treatment with once monthly Bonviva. The anticipated time on study treatment is 3-12 months, and the target sample size is 500+ individuals.


Eligibility Criteria:
Inclusion Criteria:

* ambulatory post-menopausal women with osteoporosis;
* 55-85 years of age;
* eligible for bisphosphonate treatment;
* naive to bisphosphonate therapy, or lapsed users (last bisphosphonate intake \> 6 months ago).

Exclusion Criteria:

* inability to stand or sit in an upright position for at least 60 minutes;
* inability to swallow a tablet whole;
* hypersensitivity to bisphosphonates;
* administration of any drug, or presence of active disease, known to influence bone metabolism;
* uncorrected hypocalcemia or other bone disturbances of bone and mineral metabolism;
* history of major upper gastrointestinal disease.
Case Collection Study in the Evaluation of Doubling Time Rates in Non-Suspicious Breast Masses Using QT Ultrasound Technology

This is a prospective case collection study to collect cases for subsequent statistical studies and future reader studies.


Eligibility Criteria:
Inclusion Criteria:

1. Female
2. Age 18 or older
3. Willing to receive QT Ultrasound Breast Scans
4. Willing to undergo an ultrasound-guided needle breast biopsy if performed after enrollment in the study
5. Willing and able to provide Informed Consent prior to any research-related procedure(s)
6. Have an identified solid non-suspicious breast mass

Exclusion Criteria:

1. Pregnancy
2. Currently breastfeeding
3. Magnetic material in the chest which in the judgement of the Principal Investigator would interfere or be impacted by the magnets utilized with the study device.
4. Not willing to provide information for primary care physician
5. History of breast cancer
6. History of treated or untreated cancer of a non-breast origin which in the judgment of the Principal Investigator would be a concern for metastatic disease to the breast
7. Physical inability to tolerate the QT scan, i.e. inability to lie prone and still for up to 30 minutes at a time
8. Open wounds, sores or skin rash present on the breast(s) or nipple discharge from the scanned breast(s)
9. Breasts too large for scanner, i.e. bra size larger than DDD or inability to successfully "fit" breast after the subject is placed on scanner
10. Body weight greater than 400 lbs. (180 kg)
11. Concurrent disease or condition which in the judgment of the Principal Investigator disqualifies the subject from participating in the study
Postoperative Hyponatremia - Are There Gender Differences?

The proposed study will focus on anesthesia and anesthesia-induced hypotension as a possible cause for postoperative fluid retention and hyponatremia, and investigate gender differences in this response.

30 healthy women and 30 healthy men, who are scheduled for surgery of the middle ear or parotic gland are included in the study. Within each gender group, the subjects are randomized to receive perioperative intravenous fluid regimes either based on body weight or lean body mass (LBM). The surgery lasts for at least 3 hours, the intervention period (fluid administration according to protocol) will last 10-12 hours, the study period will be 20-24 hours. Blood samples for analysis of plasma sodium, potassium, glucose and osmolality are collected preoperatively and the following morning together with analysis of urine produced during the study period.

Eligibility Criteria:
Inclusion Criteria:

* ASA Physical status I-II
* Subjects scheduled for otorinolaryngoiatric surgery in general anesthesia of at least 3 hours duration

Exclusion Criteria:

* BMI less than 18
* BMI greater than 33
* Diabetes mellitus requiring medication
* Treatment with diuretics
* ACE-inhibitors
* Angiotensin II antagonists
* Cortisone
* Lithium
* Diseases of the kidney
* Females:

  * Pregnancy
  * Menopause
  * Endocrine dysfunction influencing menstruation
Efficacy and Safety of Alflorex Bei Reizdarm in Patients With Irritable Bowel Syndrome

This Post-Market Clinical-Follow Up (PMCF) study gains data on the efficacy and safety of "Alflorex bei Reizdarm", a probiotic based on Bifidobacterium longum 35624, in the daily use by irritable bowel syndrome (IBS) patients. The aim of this study is the observation of the influence of "Alflorex bei Reizdarm" on typical symptoms, severity score and quality of life of IBS patients in medical practice and everyday use.

This Post-Market Clinical-Follow Up (PMCF) study observes adult patients with irritable bowel syndrome (IBS) which receive "Alflorex bei Reizdarm", a probiotic based on Bifidobacterium longum 35624, for 8 weeks by recommendation of their physician. IBS symptoms are recorded on a weekly basis by the participants. IBS severity score, interference with general life and safety parameters are also recorded. Primary objective is the assessment of the change in overall IBS symptoms (sum of abdominal pain, bloating, gas, difficulty in defecating/constipation and urgency/diarrhoea).

Eligibility Criteria:
Inclusion Criteria:

Adult, diagnosed IBS patients with typical IBS symptoms (abdominal pain, bloating, gas, constipation or diarrhea) and physician's recommendation to take the study medication (probiotic with B. longum 35624) for 8 weeks

Exclusion Criteria:

-