cyrilzakka/clinical-trials huggingface dataset:
Uterine Fibroid Pregnancy Registry

The Uterine Fibroid Pregnancy Registry is a USA and European-based registry designed to monitor pregnancies in women with uterine fibroids in order to

1. estimate the risk ratio of birth defects in women with uterine fibroids who were treated or untreated during pregnancy and
2. detect any pattern of birth defects among pregnancies in specific treatment groups.

Those pregnant women exposed to various therapies used to treat uterine fibroids will be compared with those not exposed to treatment in order to detect any potential increase in the risk of major birth defects.

This is a prospective, observational, registration and follow-up study of patients with uterine fibroids who become pregnant and their offspring. Those who are exposed to treatment at any time during pregnancy or within one month of conception will be compared with those not exposed to treatment. Enrollment of patients into the Registry may be initiated by health care providers and/or pregnant patients. Health care providers provide all information related to the pregnancy and the outcome.

During the study, data will be collected on uterine fibroids, exposure to treatment for uterine fibroids, potential confounding factors, and pregnancy outcome. Reported cases will be reviewed and classified according to type of birth defects. Registry enrollment is voluntary and should occur as early in pregnancy as possible, preferably before any prenatal testing. Midway between enrollment and the expected date of delivery, the Registry conducts a short interim follow-up with the health care provider to supplement registration data. Near the estimated date of delivery, the Registry prompts the health care provider to provide pregnancy outcome data. The data elements requested include:

* Health care provider contact information
* Eligibility criteria
* Uterine fibroid treatment (30 days prior to conception and during pregnancy and includes non-steroidal anti-inflammatory drugs, oral contraceptive pills, progestational agents, gonadotropin-releasing hormone (GnRH) agonists, and other oral agents)
* Pregnancy/Birth outcome
* Maternal information
* Prenatal tests
* Uterine fibroid classification

If a live birth is reported, the Registry conducts the follow-up with the infant's health care provider within 2 months of birth, and at 12 months of age. If a birth defect is indicated, the Registry will request additional targeted follow-up information from the health care provider. Data on any adverse event will be forwarded to the Sponsors.

Eligibility Criteria:
Inclusion Criteria:

* Patient is currently pregnant or report is a retrospective defect
* Patient was diagnosed with uterine fibroids prior to becoming pregnant
* Patient is between the ages of 20 and 55
Safety and Effectiveness of a Multifocal Intraocular Lens (IOL)

To evaluate the safety and effectiveness of the ZM900 Tecnis Multifocal lens. Results from two studies (an original study with 125 multifocal and 123 monofocal subjects, protocol DIOL-101-TCNS, and an expansion study with 222 additional multifocal subjects, protocol DIOL-104-TCNS) are combined to evaluate the ZM900 Tecnis Multifocal lens vs. a monofocal control. The original study was conducted in 2004-2006; the expansion study was conducted in 2007-2008. Results from both studies were analyzed together for FDA approval.

The original study was protocol DIOL-101-TCNS; the expansion study was protocol DIOL-104-TCNS. The study protocols were almost identical with the exception that no control subjects were enrolled in the expansion study; only additional multifocal subjects. All eligibility criteria and testing conducted in the expansion study was the same as that in the original study. The hypotheses were that best corrected distance visual acuity of the ZM900 lens would meet or exceed the FDA grid values, complication and adverse event rates of the ZM900 would be similar to the FDA grid rates for posterior chamber IOLs, and near visual acuity of the ZM900 lens would be improved compared to that of the monofocal control lens.

Eligibility Criteria:
Inclusion Criteria:

* Visual potential of 20/30 or better in each study eye
* Preoperative BCDVA worse than Snellen 20/40 or worse than 20/30 in the presence of glare (as measured using a Snellen chart with BAT at medium)
* Naturally dilated pupil size (in dim light) \> 4.0 mm (with no dilation medications) for each study eye
* Preoperative corneal astigmatism of 1.0 D or less

Exclusion Criteria:

* Use of systemic or ocular medications that may affect vision (the use of any miotic agent is specifically contraindicated)
* Acute or chronic disease or illness that would increase the operative risk or confound the study outcome(s),(e.g., diabetes mellitus, immunocompromised, connective tissue disease, etc.)
* Uncontrolled systemic or ocular disease
* History of ocular trauma or prior ocular surgery or subjects expected to require retinal laser treatment or other surgical intervention
* Presence of ocular pathology other than cataract such as:

  * Amblyopia or strabismus
  * Corneal abnormalities
  * Pupil abnormalities
  * Capsule or zonule abnormalities
  * Intraocular inflammation
  * Known pathology that may affect visual acuity and/or are predicted to cause future acuity losses to a level of 20/30 or worse (e.g. macular degeneration)
* Requiring an intraocular lens outside the study diopter range
* Contact lens usage prior to study procedure (time interval dependent upon contact lens type)
Interaction Between Body Posture and Nocturnal Sleeping Disorders in Dysgnathic Patients

The role of head posture has been demonstrated in patient with dentofacial deformities. However, the relationship between body posture and jaw disorders is unclear. Moreover, patients with obstructive sleep apnea have the same anatomical abnormalities than patients with dentofacial deformities. The aim of this study is to evaluate, firstly, nocturnal sleeping disorders among patients with jaw disorders. Secondly, the investigators aim to evaluate the interaction between body posture, breathing and dentofacial deformities.

A polygraphy will be performed on patient with dentofacial deformities before and after correcting jaw surgery. A postural evaluation will be done using EOS imaging system and a force plate


Eligibility Criteria:
Inclusion Criteria:

* patient in orthodontic preparation for a surgical treatment,
* age \> 16 years

Exclusion Criteria:

* postural disorder (scoliosis, history of spine surgery),
* pregnancy or breastfeeding,
* patients under guardianship
A Randomized, Double Blind, Placebo-controlled Study to Assess the the Preemptive Benefit of Etoricoxib in Patients Receiving Anterior Cruciate Ligament Reconstruction

Post surgical pain associated with ligament reconstruction may persist for few days after the surgical procedure. Arcoxia is a new anti-inflammatory and analgesic drug that alleviate pain through oral administration. This study will test the safety and efficacy of Arcoxia in the management of post-operational pain in patients receive the ligament reconstruction surgery.


Eligibility Criteria:
Inclusion Criteria:

1. Men and women age ranged from 16\~35 who have anterior cruciate ligament injury and/or associated injuries are scheduled for ACL reconstruction surgery.
2. Patient agrees to participate into this study and is willing to sign the patient informed consent form.
Vertebral Artery and Cerebral Hemodynamics After Various Head Positions & Manipulation in Patients With Neck Pain

The Investigators are performing a study to determine, in patients with chronic/recurrent neck pain, the cerebrovascular hemodynamic consequences of cervical spine movements, including manipulation, in vivo using fMRI technology on vertebral and cranial blood flow dynamics affecting brain perfusion, and extend the current data set on these variables

The goal of the study is to further investigate in patients with chronic/recurrent neck pain, the cerebrovascular hemodynamic consequences of cervical spine positions, including manipulation, in vivo under clinically relevant circumstances using two advanced MRI technology on the vertebral and posterior cerebral and cerebellar blood flow dynamics affecting brain perfusion. According to the knowledge of the investigators, a study utilizing MRI to examine blood flow and perfusion, turbulence and evidence of micro-trauma within these blood vessels has yet to be conducted.

Eligibility Criteria:
Inclusion Criteria:

1. Adults aged 18 years and older with chronic/recurrent neck pain Grade II.
2. Must have been prescribed cervical spinal manipulation for treatment of their neck pain condition.

Exclusion Criteria:

1. A history of neck pain with associated arm pain within the last 6 months
2. Any current or history of neurologic symptoms including facial or extremity weakness, abnormal sensation to the face, body, or extremities, uncontrolled movements, abnormal gait, dizziness, unexplained nausea/vomiting, difficulty with speaking or swallowing
3. History of new or severe (Visual Analogue Scale \>6) headaches in the last 3 months
4. Any contraindications to MRI
5. Any history of using drugs that affect blood flow such as Warfarin, or anti-coagulants.
Cetuximab/Paclitaxel/Cisplatin Concurrent Chemoradiotherapy Followed by Esophagectomy for Loco-regional Esophageal Cancer

We hypothesize that the addition of cetuximab to twice weekly paclitaxel/cisplatin concurrent chemoradiotherapy (TP-CCRT) as the adjunctive therapy before esophagectomy or as a definitive CRT would improve the therapeutic efficacy of TP-CCRT in patients with loco-regional esophageal squamous cell carcinoma (ESCC).

We hypothesize that the addition of cetuximab to twice weekly paclitaxel/cisplatin concurrent chemoradiotherapy as the adjunctive therapy before esophagectomy or as a definitive CRT would improve the therapeutic efficacy of TP-CCRT in patients with loco-regional esophageal squamous cell carcinoma.

Eligibility Criteria:
Inclusion Criteria:

1. Pathologically proven squamous cell carcinoma of esophagus.
2. Loco-regional diseases, which are defined by TNM system of American Joint Committee on Cancer (AJCC) Cancer Staging System (6th edition) in 2002, fulfilling one of the following criteria:

   A. T3, N0, M0; B. T1-3, N1, M0; C. T1-3 or N0-1, M1a will be eligible provided the lesions could be covered by appropriate radiation fields.
3. Age ≥ 18 years old.
4. Performance status ECOG 0\~2.
5. Adequate bone marrow reserves, defined as:

   A. white blood cells (WBC) ≥ 4,000/µl or neutrophil count (ANC) ≥ 2,000/µl; B. platelets ≥ 100,000/µl.
6. Adequate liver function reserves, defined as:

   A. hepatic transaminases ≤ 2.5 x upper limit of normal (ULN); B. serum total bilirubin ≤ 1.5 x upper limit of normal (ULN).
7. Adequate renal function: Creatinine ≤1.5 mg/dl
8. Written informed consent.

Exclusion Criteria:

1. Invasion to surrounding organ (T4 disease).
2. Distant metastasis, except M1a disease listed in the inclusion criteria 2-C.
3. Adenocarcinoma of gastroesophageal (GE) junction.
4. Prior thoracic irradiation.
5. Synchronously diagnosed squamous cell carcinoma of aerodigestive way, other than esophageal cancer.
6. Prior malignancy, except for the following:

   A. adequately treated basal cell or squamous cell skin cancer; B. in-situ cervical cancer; C. Note: previously treated aerodigestive squamous cell carcinoma is not allowed.
7. Significant co-morbid disease, which prohibit the conduction of chemotherapy, concurrent chemoradiotherapy, or radical surgery, such as active systemic infection, symptomatic cardiac or pulmonary disease, or psychiatric disorders.
8. Estimated life expectancy less than 3 months.
Metabolic Effects of the Manipulation of Nutrient Sequence in the Main Meals in Type 2 Diabetic Patients

The investigators aimed at evaluating the metabolic effects of the inversion of the typical Italian sequence of food ingestion at the main meals in type 2 diabetic patients.

An intervention group follows a modified diet over a period of two months in which the ingestion of protein and lipid happens before that of carbohydrates. A control group follows a standardized diet in which the ingestion of carbohydrates happens before that of protein and lipid. Both diets contain a reduced intake of high-glycemic index meals, saturated fatty acids, trans fatty acids and alcohol.

On four days separated by one month each other (two before the beginning of the diet and two after 1 month and 2 months of diet) we measure clinical and metabolic parameters (weight, waist and hip circumferences, glucose, glycated hemoglobin, fructosamine, lipid profile) to compare the effects of the two diets.

Eligibility Criteria:
Inclusion Criteria:

* Well-controlled type 2 diabetes
* HbA1c 48-58 mmol/mol (6.5-7.5%)
* Treatment with metformin or diet only
* BMI: \< 35 kg/m\^2

Exclusion Criteria:

* Autoimmune diseases, neoplasia, heart, kidney, liver or respiratory failure
* Pregnancy
* Bariatric surgery
Impact of Beta-3 Agonist on Psychological Distress and Blood Flow of the Bladder in Women With Overactive Bladder Syndrome

We will get the impact of mirabegron on psychological distress, urethra and bladder blood flow and c reactive protein.

Background/Purpose: Pharmacologic treatments for female overactive bladder syndrome (OAB) include antimuscarinics and beta-agonist. Similar efficacy has been reported between antimuscarinics and beta-agonist. Antimuscarinics has been found to be beneficial for patients with psychological distress. However, the impact of mirabegron on psychological distress in female OAB remains unknown. In addition, some animal studies found that beta-3 agonist can improve arterial blood flow, bladder ischemia and might improve bladder function; however, there is still lack of human study. Besides, c reactive protein was found to be elevated in female OAB. Nonetheless there is no study mentioning about the impact of mirabegron on c reactive protein. Thus, the aim of this study is to elucidate the impact of mirabegron on psychological distress, bladder blood flow and c reactive protein.

Eligibility Criteria:
Inclusion Criteria:

* All OAB female patients
* \>20 years

Exclusion Criteria:

* Allergy to mirabegron, urinary tract infections
The Prognosis of Migraine and Tension-Type Headache in Children and Adolescents

Children and adolescents that visited the pediatric neurology clinic at the Bnai Zion medical center do to migraine or TTH headache between the years 2007-2010 were reevaluated. We used a structured headache questionnaire through a phone interview with the patients and their caregivers. Data regarding demographics, the patients' and families' medical history, and headache history, past and current (age at onset, location, quality, frequency, duration of episodes, aura, associated symptoms and treatment) were collected.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of migraine or TTH headache according to the ICHD-3 criteria.
* Can describe the current headache status.

Exclusion Criteria:

\* Secondary headaches.
Young Adult Hypertension Feasibility Study

This study was designed to evaluate the feasibility of a telephone-based health coach self-management intervention for young adults.

To address the unmet need for hypertension care in young adults, MyHEART (My Hypertension Education and Reaching Target), a multi-component hypertension intervention was developed. Eligible patients were identified via the healthcare system's electronic health record.

Inclusion criteria included:

1. 18-39 years old at the start of the study,
2. previous hypertension ICD-9 coded office visits and
3. uncontrolled hypertension (≥140/90 mmHg) based on the last ambulatory blood pressure reading.

Exclusion criteria included a pre-defined list of co-morbidities, in addition to planned or current pregnancy, any health condition that limits physical activity or dietary changes, current participation in another study, and planning to leave the area in the next three months. During the feasibility study, all participants continued to receive usual hypertension care from their primary care provider. The intervention involved health coach calls over a 3-month period using self-management modules. The order of the modules was guided by the participant's choice. All encounters were documented in the electronic health record. Patient acceptability and home blood pressure monitoring survey data was acquired.

Eligibility Criteria:
Inclusion Criteria:

* 18-39 years old at the start of the study
* previous hypertension ICD-9 coded office visits
* uncontrolled hypertension (≥140/90 mmHg) based on the last ambulatory blood pressure reading

Exclusion Criteria:

* Chronic Kidney Disease (Stage 4 or 5 or Dialysis)
* Congestive Heart Failure, Any Etiology
* Activated Healthcare Power of Attorney
* Skilled nursing facility or correctional facility residence
* Currently enrolled in case management or chronic disease management support services
* Sensitive condition diagnosis (e.g. HIV)
* Prescribed warfarin, novel oral anticoagulant, or insulin
* Diagnosis of sickle cell anemia or cystic fibrosis
* Prior stroke, myocardial infarction, coronary artery revascularization
* Syncope within past 12 months
* Prior or planned organ transplant
* Chemotherapy or radiation therapy within 6 months
* Severely impaired hearing or speech
* Current participation in another research study
* Pregnant/planning to become pregnant in the next 12 months
* Planning to leave the area in the next 3 months
* Any health condition that will limit physical activity or dietary changes
* Illegal drug use (other than marijuana) in the past 30 days (Self-report)
* Unable to read or communicate in English
Comparison of Effectiveness of Zinc Supplementation With ORS and Bacillus Clausii Versus Zinc With ORS and Saccharomyces Boulardii in Acute Watery Diarrhea in Paediatric Patients

The current study was carried out to directly compare the effectiveness of zinc supplementation with ORS and Bacillus clausii versus zinc with ORS and Saccharomyces boulardii among the local pediatric population presenting with acute watery diarrhea.

The results and importance of effective treatment for acute watery diarrhea in pediatric patients vary throughout the world. Previously, very limited literature was available comparing the efficacy of Bacillus clausii and Saccharomyces boulardii in acute watery diarrhea, providing mixed results. The current study aims to directly compare the effectiveness of zinc supplementation with ORS and Bacillus clausii versus zinc with ORS and Saccharomyces boulardii.

Eligibility Criteria:
Inclusion Criteria:

* Patients of either gender
* Aged 3 months to 5 years
* With acute watery diarrhea last less fewer than 14 days
* Presenting with mild to moderate dehydration

Exclusion Criteria:

* Patients with a history of blood or pus in their stools
* History of recent antibiotic or probiotic treatment
* Patients with immunodeficiency conditions, acute systemic illnesses, or chronic diarrhea
* Patients with hypersensitivity to Bacillus clausii or Saccharomyces boulardii
A Study Validating the Use of Candin as a Challenge Agent in Healthy Participants - Intervention Specific Appendix 3

The purpose of this study is to characterize the delayed-type hypersensitivity (DTH) response at the site of Candin intradermal injection in the presence of a targeted immune pathway inhibitor.


Eligibility Criteria:
Inclusion Criteria:

* Have a body mass index (BMI) between 18 and 30 kilograms per meter square (kg/m\^2) (BMI = weight/height\^2), inclusive, and a body weight of no less than 50 kilograms (kg)
* Healthy on the basis of physical examination, medical history, and vital signs performed at screening. Any abnormalities, must be considered not clinically significant and this determination must be recorded in the participant's source documents and initialed by the investigator
* Healthy on the basis of clinical laboratory tests performed at screening. If the results of the serum chemistry panel, hematology, or urinalysis are outside the normal reference ranges, the participant may be included only if the investigator judges the abnormalities or deviations from normal to be not clinically significant or to be appropriate and reasonable for the population under study. This determination must be recorded in the participant's source documents and initialed by the investigator
* Must sign an informed consent forms (ICFs) indicating that he or she understands the purpose of, and procedures required for, the study and is willing to participate in the study
* A woman must agree not to donate eggs (ova, oocytes) or freeze for future use for the purposes of assisted reproduction during the study and for a period of 30 days after the last dose of study intervention

Exclusion Criteria:

* History of liver or renal insufficiency, significant cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, psychiatric, or metabolic, or mucocutaneous disturbances
* History of any type of immunodeficiency or autoimmune disease or disease treatment associated with immune suppression or lymphopenia. These include but are not limited to bone marrow or organ transplantation, lymphoproliferative disorders, T- or B-cell deficiency syndromes, splenectomy, functional asplenia and chronic granulomatous disease
* Any condition for which, in the opinion of the investigator, participation would not be in the best interest of the participant (for example, compromise the well-being) or that could prevent, limit, or confound the protocol-specified assessments
* Has experienced a recent single dermatomal herpes zoster eruption within the past 6 months or has had multi-dermatomal herpes zoster or central nervous system zoster within the past 5 years
* Has surgery planned within 30 days after study intervention administration
Chinese Multi-provincial Cohort Study-Beijing Project

The Chinese Multi-provincial Cohort Study (CMCS)-Beijing project is a sub-study in CMCS participants from Beijing, which intended to investigate the progression and determinants of atherosclerosis and aging related health problems through repeat examinations. Exam 0 to Exam 3 have been conducted during 1992 to 2012. Exam 4 is scheduled in 2020.


Eligibility Criteria:
Inclusion Criteria:

* Participants from CMCS-Beijing
* sign the informed consent

Exclusion Criteria:

* participanting in clinical trials
Mechanocardiography in Patients With STEMI

The study aim is to evaluate the capability of mechanocardiography in detecting acute myocardial ischemia in patients suffering evolving ST-segment elevation infarction.

Subsequent patients with ST-segment elevation assigned to the Turku University Hospital Heart Center cathlab for primary percutaneous coronary intervention are enrolled in the study. A 2 to 15 minutes mechanocardiographic recording is acquired before the intervention. A control recording is collected after the coronary intervention, within 24 hours. These recordings are compared and the results analyzed to determine the ability of this novel modality to discriminate between the two circumstances.

Eligibility Criteria:
Inclusion Criteria:

* Myocardial ischemia with ST-segment elevation in ECG
* Primary PCI procedure

Exclusion Criteria:

* Age \>17 years
* No informed consent