cyrilzakka/clinical-trials huggingface dataset:
Isolated Mild Fetal Ventriculomegaly and Neurodevelopmental Outcome

Isolated mild fetal ventriculomegaly is a common finding in fetal ultrasound examinations.

When the ventricular diameter is more than 15 mm it is usually considered as severe and connected to other malformations. Most of these children will be severely affected later in life. Less than 10 mm ventricular width considered as normal.

The current medical knowledge can not answer questions regarding future development of children who were diagnosed to suffer from mild (10-14.9 mm) brain ventriculomegaly during the pregnancy.

We would like to assess the development and neurological status of all children who were diagnosed as "mild ventriculomegaly" during the pregnancy in the last 6 years and to prospectively follow up all the children who will be diagnosed from the beginning of the study on for 6 years.

We hypothesized that the course of their development is different than of other children.

Study design:

Patients:

1. All children who are currently 5-6 year-old who suffered from isolated fetal mild brain ventriculomegaly during the pregnancy.
2. All children who will be diagnosed with isolated fetal mild brain ventriculomegaly during the pregnancy from the beginning of the study for 6 years.

Methods:

1. All children will be examined by a pediatric neurologist who will perform a neuro-developmental assessment appropriate for age. The neurologist will decide individually whether there is a need for more medical tests.
2. All children will be assessed by a psychologist who will perform WIPPSI or BAYLEY tests according to age.

Eligibility Criteria:
Inclusion Criteria:

* All children who were or are diagnosed with isolated fetal mild ventriculomegaly

Exclusion Criteria:

* Anatomic malformations
* IVH
* Hydrocephalus
* Metabolic disorder
* CNS infection
Changes in Patients' Quality of Life With Differences in Seton Application

Investigators aim to investigate the changes in patients' quality of life with different type of seton application.

Perianal fistula is a very common disease. Perianal fistula develops in the 50% of the anorectal abscess. Perianal fistulas are usually complications of recurrent anorectal abscesses. The management of the fistula is sometimes challenging and requires a long period of time. One of the treatment methods in perianal fistula is seton application. Seton is a rubber band made of various materials such as silicone, silk, latex, etc. It is passed through the fistula tract, and then the tips are tied to each other. Seton is usually kept there for 3 - 6 months depending on the condition of the fistula. Seton causes a foreign body reaction. After this process, there are various fistula management methods. Seton application is again one of the choices besides fistulotomy, fistulectomy, ablation methods, etc.

As seton is a frequently preferred method, patients should get used to living with seton. Severe irritation and a decrease in quality of life are observed in patients depending potentially on the seton binding methods.

Investigators aim to evaluate the seton application methods that will minimize the decrease in the quality of life in this difficult process for patients by comparing 3 different seton application methods that investigators apply in daily practice.

Eligibility Criteria:
Inclusion Criteria:

* -Primary perianal fistula

Exclusion Criteria:

* Suprasphincteric fistula
* Patient who had previous perianal fistula surgery
* Crohn
* Radiotherapy
* Patient with pre-existing anal incontinence
vNOTES in Elective Bilateral Salpingectomy for Sterilization

Objective: To compare the vNOTES approach versus conventional laparoscopic approach to be used in elective bilateral salpingectomy for sterilisation as an opportunistic cancer prevention strategy.

Study design: Prospective cohort, two-centred trial. Study population: All women aged over 18 who are planned to undergo for definitive surgical sterilisation regardless of parity with a non-prolapsed uterus.

Primary outcomes: (1) Patient satisfaction (at 1st week and 1st month of the surgery) measured by The Patient Global Imression of Improvement (PGI-I), (2) Postoperative early pain (Visual Analog Score (VAS) at 6th and 24th hours of the surgery).

Secondary outcomes: (1) Conversion to laparoscopy or laparotomy, (2) duration of the procedure, (3)total amount of analgesics used, (4) New-onset dyspareunia at first coitus measured by the Pain subdomain of Female Sexual Function Index (FSFI), (5) intraoperative complications, (6) postoperative complications

Women who are indicated or seek for surgical sterilisation are routinely offered salpingectomy rather than tubal ligation for cancer prevention purposes as a local protocol. Those patients will be offered for vNOTES approach after detailed patient counselling and will be enrolled to the study upon acceptation.

Eligibility Criteria:
Inclusion Criteria:

* Women aged over 18 years regardless of parity with a non-prolapsed uterus
* Patients who are indicated or seek for definitive surgical sterilisation
* Patients who prefers salpingectomy over tubal ligation after considering its possible cancer prevention effect
* Written informed consent obtained prior to surgery

Exclusion Criteria:

* Any malignancy
* Suspected rectovaginal endometriosis
* History of pelvic inflammatory disease, pouch of Douglas abscess
* Being Virgo or Pregnant
* Failure to provide written informed consent prior to surgery
National Registry of Veterans With Amyotrophic Lateral Sclerosis and DNA Bank

This study will identify living veterans with amyotrophic lateral sclerosis (ALS) through a national registry that is being developed. Diagnosis of ALS will be verified by study neurologists via medical record review. Registry participation includes a bi-annual telephone interview to collect functional status data.

Primary Objective: To identify as completely as possible all veterans with ALS and to collect data which will be available for approved studies examining the cause(s) of ALS.

Secondary Objective: To provide a mechanism for the VA to inform veterans with ALS about clinical trials and other studies for which they may be eligible.

Primary Outcomes: Identification of all living veterans with ALS.

Intervention: N/A

Study Abstract: Amyotrophic lateral sclerosis (ALS) is an adult-onset, rapidly fatal neuromuscular disease of unknown etiology. ALS is a disease of high priority to the VA, particularly due to ongoing concerns about the health of veterans who served in the Gulf War. Efforts are needed to systematically identify and track veterans with ALS. Accordingly, the Department of Veterans Affairs (VA) is developing a national registry of veterans diagnosed with ALS.

Research Design: The registry will not be designed to test specific hypotheses but will focus on comprehensive identification of veterans with ALS who may be eligible for other studies.

Methodology: Eligible participants will include all living veterans with a physician diagnosis of ALS. Veterans with possible ALS will be identified through VA medical records, the Veterans Benefits Administration (VBA), and self-referral. Neurologists with expertise in ALS will review veterans' medical records to verify the diagnosis and determine eligibility. Upon enrollment, veterans will be asked to complete a brief telephone interview. Registry participants will also be contacted by telephone biannually to assess health and functional status. The VA may notify registry participants about clinical trials for which they may be eligible. A Scientific Review Committee will evaluate all studies that request use of registry data and/or access to Registry participants.

Results: N/A

Impacts: The registry will provide the VA with a valuable mechanism for involving veterans in clinical trials and other studies that may yield improved outcomes for ALS. In addition, data gathered as a part of the registry has the potential to benefit not only veterans, but also the larger community of individuals with ALS.

Eligibility Criteria:
Inclusion Criteria:

Living veteran with ALS verified via medical record review.

Exclusion Criteria:

Veteran whose medial records did not verify an ALS diagnosis.
A Study of the Effect of Aldurazyme® (Laronidase) Treatment on Lactation in Female Patients With Mucopolysaccharidosis I (MPS I) and Their Breastfed Infants

The purpose of this study is to determine if laronidase is present in the breast milk of post-partum women receiving Aldurazyme® (laronidase) and the effects of Aldurazyme (laronidase) on the growth, development, and immunologic response of their breastfed infants.

Recruitment is not limited to the facility listed; facilities not yet active may be added upon identification of a patient.

Eligibility Criteria:
Inclusion Criteria (Mothers):

* The patient must have a documented laronidase deficiency with a fibroblast, plasma, serum, leukocyte, or dried blood spot laronidase enzyme activity assay.
* Be pregnant, planning to breastfeed post-partum, and receiving Aldurazyme (laronidase) therapy while breastfeeding.
* Provide signed, written informed consent prior to any protocol-related procedures. Consent of a legally authorized guardian(s) is (are) required for mothers younger than 18 years of age. If a mother is under 18 years old and can understand the consent, written informed consent is required from both the mother and the authorized guardian(s).
* Provide signed, written informed consent for their infants to participate as study patients. If a mother is younger than 18 years of age, consent for mother and infant will be obtained from the legal guardian.

Exclusion Criteria (Mothers and Infants):

* Have a medical condition, serious intercurrent illness, or other extenuating circumstance that may interfere with study compliance, including all prescribed evaluations and follow-up activities.
* Have received an investigational drug within 30 days prior to study enrollment.
Military Women's Health and Illness Behaviors in Deployed Settings

The purpose of this study is to gain better understanding of how recently deployed military women managed urinary and vaginal symptoms while deployed. Participants in this study will be asked to take part in a 45-60 minute interview.


Eligibility Criteria:
Inclusion Criteria:

* Deployment within the last 12 months
* Managed genitourinary symptoms while deployed (does not have to be diagnosed by a medical provider)

Exclusion Criteria:

* Women who are assigned to a medical group/hospital
An Observational Study of MabThera/Rituxan (Rituximab) in Patients With Relapsing or Refractory Chronic Lymphocytic Leukemia

This multi-center, prospective, observational study will describe the management of relapsing or refractory chronic lymphocytic leukemia (CLL) patients. Data will be collected for 2 years.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients, \>/=18 years of age
* Diagnosis of relapsed or refractory chronic lymphocytic leukemia (CLL) with first or second relapse
* Previous treatment with MabThera/Rituxan
* MabThera/Rituxan treatment planned for current relapse

Exclusion Criteria:

* Richter syndrome
* Life expectancy \<6 months
A Pilot Study of Empagliflozin in the Treatment of Acromegalic Cardiomyopathy

Acromegaly is a disease characterized by excess growth hormone(GH) and insulin like growth factor(IGF)-1. Pituitary GH secreting adenoma is the major cause of acromegaly. Acromegalic cardiomyopathy is one of the leading causes of death in acromegalic patients. No efficient medicine is available for acromegalic cardiomyopathy until now and there were limited studies. Empagliflozin is proved to decrease the risk of heart failure in diabetic patients and independent of blood glucose control. We planed to evaluate the structure of heart by MRI before and after 6 months treatment with empagliflozin in acromegalic patients to investigate the effect of empagliflozin on acromegalic cardiomyopathy.


Eligibility Criteria:
Inclusion Criteria:

* patients with pituitary GH adenomas confirmed by surgery

active acromegalic patients although treated with surgery,radiation therapy and somatostatin analogs

Exclusion Criteria:

* patients with contraindications to empagliflozin pregnant patients patients with poor control of hypertension(SBP\>150mmHg or DBP\>95mmHg patients with contraindications to MRI
BESPONSA Injection 1 mg Special Investigation

The purpose of this study is to learn about the safety and effectiveness of BESPONSA. BESPONSA is approved for treatment of relapsed or refractory CD22-positive acute lymphocytic leukemia.

Registration criteria for this study is all patients who starting BESPONSA from its launch to the market to April 30, 2020.

All patients in this study will receive BESPONSA according to the prescriptions.

Patients will be followed up as follow.

* 52 weeks for patients who did not have a HSCT (Hematopoietic Stem Cell Transplant) within 52 weeks after starting BESPONSA.
* Up to 52 weeks after a HSCT for patients who had a HSCT within 52 weeks after starting BESPONSA.


Eligibility Criteria:
Inclusion Criteria:

* All patients prescribed BESPONSA

Exclusion Criteria:

* None
Dietary Patterns, Metabolomics and Colorectal Cancer Risk

Colorectal cancer (CRC) is the third most commonly diagnosed cancer in American men and women with ≥130,000 new cases each year. Several dietary patterns have been associated with CRC risk but underlying mechanisms are not fully understood. Researchers thus propose to integrate dietary patterns and metabolomics data to comprehensively investigate biological pathways linking dietary patterns and CRC risk.

Several dietary patterns have been associated with colorectal cancer (CRC) risk but underlying mechanisms are not fully understood. Also, evidence is lacking on the consistency of dietary guidelines for overall health and CRC prevention given that it is not feasible to have an optimal diet for every disease. Furthermore, metabolomic profiling has not been widely assessed with respect to CRC risk. Metabolomics is uniquely suited to assess metabolic responses to dietary stimuli, given that it is situated downstream to all the other "omics". Building on prior work in hypothesis-driven dietary patterns and CRC prevention, the researchers seek to fill these knowledge gaps by proposing to: 1) use a standardized methodology to compare the best diet for overall health with the best diet for CRC prevention, and further determine if any associations of dietary patterns with CRC prevention are mediated by mechanisms involving inflammation and insulin; 2) determine metabolites that may mediate the association of dietary intake with CRC risk. The researchers will utilize two large prospective cohort studies, the Nurses' Health Study (NHS) and the Health Professionals Follow-up Study (HPFS), in which dietary and nondietary data have been collected every 2 to 4 years among 173,230 women and men over the last ≥30 years, with ≥3,400 CRC cases and ≥43,800 all-cause deaths. This integrated interrogation of dietary patterns and metabolomics data will inform the design of guidelines for healthful lifestyles that are optimized for CRC prevention.

Eligibility Criteria:
Inclusion Criteria:

-Adult health professionals

Exclusion Criteria:

* Any cancer except nonmelanoma skin cancer
* Did not complete a food frequency questionnaire during follow-up
* Had implausible values for total energy intake (\<600 or \>3500 kcal/d for women and \<800 or \>4,200 kcal/d for men) at study entry
Myocardial Stress Perfusion Computed Tomography in the Evaluation of Patients With Acute Chest Pain Using a Novel 3rd Generation Dual-source CT System

To assess the ability of a novel 3rd generation dual-source CT system to demonstrate myocardial perfusion in a cohort of patients presenting to the Chest Pain Center with acute chest pain.

The investigators will assess the latest generation of CT scanner for heart disease detection. On this new machine the investigators will analyse the ability of the machine to show the delivery of blood to the heart muscle. Results will be compared with the results from the gold standard test for myocardial perfusion imaging, which is an imaging test that shows the blood supply to the heart muscle. Further analyses will record the amount of radiation, which is how the CT machine acquires images, and compare the amount of radiation necessary to produce images to previous CT systems. With this new CT system there should be reductions in the amount of radiation dose compared to previous systems.

Eligibility Criteria:
Inclusion Criteria:

* Subject must present with symptoms of acute but atypical or recurrent chest pain.
* Subject must have been referred for cardiac CT angiography OR subject must have undergone clinically indicated SPECT with positive or equivocal findings OR subject must have undergone clinically indicated SPECT with prior cardiac CT angiography that showed moderate or severe stenosis.
* Subject must be 18-85 years of age.
* Subject must provide written informed consent prior to any study-related procedures being conducted.
* Subject must be willing to comply with all clinical study procedures.

Exclusion Criteria:

* Subject is a pregnant or nursing female.
* Subject has severe asthma or COPD requiring frequent inhaler use.
* Subject has prior diagnosis of obstructive CAD that has not been revascularized.
* Subject with implanted rhythm devices (pacemaker, defibrillator).
* Subject has significant arrhythmia.
* Subject has high grade heart block.
* Subject has resting heart rate \< 45 bpm, systolic blood pressure \<90 mm Hg, or has consumed caffeine within the last 12 hours.
* Subject has an acute psychiatric disorder.
* Subject is unwilling to comply with the requirements of the protocol.
* Subject has previously entered this study.
* Subject has an allergy against iodinated contrast or pharmaceutical stressors used in this study.
* Subject suffers from claustrophobia.
* Subject has impaired renal function (creatinine \> 1.5 mg/dl).
* Subject is in unstable condition.
* ST-elevations, new transient ST changes greater than 0.05mV or T-wave inversions with symptoms.
* Subject cannot safely be administered Lexiscan per prescribing information as as determined by investigator.
* Subject has received interventional (PCI, stenting) or surgical (CABG) treatment that may alter the cardiac condition regarding myocardial perfusion status and/or stenosis degree between cardiac CTA, SPECT, and/or CT stress perfusion studies.
Deoxycholic Acid Injection for the Treatment of Superficial Lipomas

The purpose of this research is to compare the safety and effectiveness of 4 different concentrations of deoxycholic acid injection against a placebo in the treatment of superficial lipomas.

A lipoma is a fatty lump typically located on the trunk, shoulder, arms or legs. For the purposes of this study, only lipomas on the trunk, arms, legs, or neck were treated. (Lipomas on the face, wrists, hands, lower portion of the spine, genitals, ankles, or feet were not treated.)

Eligibility Criteria:
Inclusion Criteria:

* One or more lipomas, based on clinical diagnosis, which are accessible for treatment and assessment, are quantifiable along at least 2 perpendicular diameters, and have the following characteristics:

  * History of slow growth followed by dormancy, and stable for at least 6 months.
  * Greatest length by greatest perpendicular width between 1 and 16 square centimeters, inclusive
  * Discrete, oval to rounded in shape, not hard or attached to underlying tissue
  * Located on the trunk, arms, legs, or neck
* Stable body weight with a body mass index of less than 30 kg/m²
* Signed informed consent

Exclusion Criteria:

* Absence of significant medical conditions that could affect safety
* History of surgical treatment for lipomas
* Treatment with an investigational agent within 30 days before ATX-101 treatment
Study to Evaluate the Efficacy and Safety of PF-06480605 in Adult Participants With Moderate to Severe Crohn's Disease

This Phase 2a, multicenter, randomized, double-blind, placebo-controlled study examines subcutaneous dose of PF-06480605 150 mg administered every 4 weeks in participants with moderate to severe active Crohn's Disease to characterize safety, efficacy, pharmacokinetics, and immunogenicity


Eligibility Criteria:
Inclusion Criteria:

* Confirmed diagnosis of ileocolonic or colonic CD with at least 3 months or longer prior to the baseline;
* Central read total SES-CD score of ≥7. For isolated ileal disease, SES-CD total score should be ≥4;
* An average daily liquid/very soft SF ≥4 or daily AP score ≥2.0;
* CDAI between 220 and 450 inclusive;
* Must have inadequate response to, loss of response to, or intolerance to at least one conventional therapy for CD

Exclusion Criteria:

* Diagnosis of indeterminate colitis, microscopic colitis, ischemic colitis, infectious colitis, radiation colitis, diverticular disease, UC, or clinical findings suggestive of UC;
* Presence of active (draining) fistulae or intra-abdominal or perineal abscesses;
* Strictures or stenosis with obstructive symptoms;
* Short bowel syndrome;
* History of bowel perforation requiring surgical intervention within the past 12 months prior to baseline;
* Previous bowel surgery resulting in an existing stoma. Participants who have a j-pouch are excluded, as a j-pouch can result in a stoma;
* History of bowel surgery within 6 months prior to baseline.
Cohort Study of Pioglitazone and Cancer Incidence in Participants With Diabetes Mellitus.

The purpose of this study was to evaluate whether treatment with pioglitazone is associated with risk of incident cancer at the 10 most common sites in a cohort of participants with recognized diabetes.

The study enroll a large population of approximately 252467 participants. The study would analyze association of cancer and pioglitazone in 2 cohorts based on the usage of pioglitazone. Participants in were originally planned to be followed-up from January 1, 1997 to December 31, 2005. Based on the discussion with advisory board, it was recommended to increase the study population and duration of follow-up. The follow-up period was extended to June 30, 2012 for the study.

This multi-center trial was conducted in the United States of America. The overall time to participate in this study was approximately 15.5 years. Participants were followed-up from January 1, 1997 up to June 30, 2012 for the assessment of cancer risk associated with pioglitazone use.

Eligibility Criteria:
Inclusion Criteria:

1. has been in the KPNC diabetes registry Diabetes Mellitus (DM) registry, aged 40 years or older and are members of KPNC as of January 1, 1997, or
2. has been in the DM registry, reached aged 40 years between January 1, 1997 and June 30, 2005 and are KPNC members on their 40th birthday, or
3. has joined KPNC after January 1, 1997, aged 40 years or older when they are identified by the DM registry between January 1, 1997 and June 30, 2005.

Exclusion Criteria: 1. Age less than (\<) 40 years during study period. 2. No KPNC medication benefits at the time of entry into the cohort (baseline) or gap in medication benefit greater than equal to (\>=) 4 months that started in the first 4 months after entering in the cohort.

3. Gap in KPNC membership \>= 4 months that started in the first 4 months after entering in the cohort.

4. Participant with a diagnosis of Human immunodeficiency virus (HIV). 5. Participants with evidence of selected surgeries for some cancer sites. 6. All prevalent cancers at baseline, that is, all participants ever diagnosed with cancer other than non-melanoma skin cancer.