cyrilzakka/clinical-trials huggingface dataset:
A Study to Assess Stroke Risk Among Users of Typical Versus Atypical Antipsychotics Stratified by Broad Age Group

The purpose of this study is to extend the recent Food and Drug Administration (FDA) Sentinel tabulations regarding stroke risk among new users of typical and atypical antipsychotics to participants who were aged 18-64 years and did not have dementia to participants aged 65 years and older regardless of dementia status.


Eligibility Criteria:
Inclusion Criteria:

For entry event of an initial drug exposure:

* First exposure to the particular drug(s) in the past 183 days (index date)
* Had at least 183 days of continuous observation time prior to index
* Exactly 0 condition occurrences of 'Cancer' any time in the 183 days before or on the index date
* Exactly 0 condition occurrences of 'Stroke' any time in the 183 days before or on the index date
* Exactly 0 exposures to any other typical or atypical antipsychotics any time in the 183 days before or on the index date
A Study to Assess the Efficacy and Safety of Induction Therapy With RO7790121 in Participants With Moderately to Severely Active Crohn's Disease

This Phase III, multicenter, double-blind, placebo-controlled study will evaluate the efficacy and safety of induction therapy with RO7790121 in participants with moderately to severely active Crohn's disease (CD).


Eligibility Criteria:
Inclusion Criteria:

* Confirmed diagnosis of CD
* Moderately to severely active CD
* Bodyweight \>= 40 kilogram (kg)
* Demonstrated inadequate response, loss of response and/or intolerance to at least one protocol-specified conventional or advanced CD therapy
* Males and females of childbearing potential must meet protocol criteria for contraception requirements

Exclusion Criteria:

* Current diagnosis of ulcerative colitis (UC) or indeterminate colitis, ischemic colitis, infectious colitis, radiation colitis, microscopic colitis
* Participant with a history of \>= 3 bowel resections (\> 2 missing segments of the 5 following segments: terminal ilelium, right colon, transverse colon, sigmoid and left colon, and rectum)
* Diagnosis of short gut or short bowel syndrome
* Presence of an ileostomy, colostomy or ileoanal pouch
* Participants with symptomatic bowel strictures, fulminant colitis, or toxic megacolon
* Presence of abdominal or perianal abscess
* Presence of rectovaginal fistulas or perianal fistulas with \>3 openings
* Participants with symptomatic bowel strictures, fulminant colitis, or toxic megacolon
* Current diagnosis or suspicion of primary sclerosing cholangitis
* Pregnancy or breastfeeding, or intention of becoming pregnant during the study
* Past or current evidence of definite low-grade or high-grade colonic dysplasia or adenomas or neoplasia not completely removed
* History of malignancy within 5 years, with the exception of malignancies adequately treated with resection for non-metastatic basal cell or squamous cell cancer or in situ cervical cancer
* Evidence of infection with Clostridioides difficile (C. difficile; formerly known as Clostridium difficile), cytomegalovirus (CMV), human immunodeficiency virus (HIV), Hepatitis B (HBV), Hepatitis C (HCV)
* Has evidence of active tuberculosis (TB), latent TB not successfully treated (per local guidance) or inadequately treated TB
* Has received protocol-specified prohibited medicines, including known exposure to any type of anti-TL1A therapy
(TIMP-2)x(IGFPB7) to Predict Acute Kidney Injury (AKI) in Aortic Surgery

New biomarkers that predict the development of renal dysfunction in patients with aortic surgery are urgently needed. The investigators investigate whether urinary (TIMP-2)x(IGFBP7) predicts postoperative Acute Kidney Injury and/or need for Renal Replacement Therapy (RRT) in patients after aortic surgery (including EVAR).


Eligibility Criteria:
Inclusion Criteria:

* Patients in need of emergency or elective abdominal aortic surgery (infra- or suprarenal clamping or EVAR) are eligible for study inclusion.

Exclusion Criteria:

* Patients unable to give informed consent
* Age \< 18
* Patients not speaking German or French.
Water and the Gastropressor Response - Tachyphylaxis

We are studying the effects of oral water ingestion in patients with orthostatic hypotension. In this study, we are testing the null hypothesis that the blood pressure increase with oral water ingestion will not be diminished if a full prior water dose is given a few hours earlier.

We are studying the effects of oral water ingestion in patients with orthostatic hypotension. This has been termed the Gastropressor Response. In this study, we are testing the null hypothesis that the blood pressure increase with oral water ingestion will not be diminished if a full prior water dose is given a few hours earlier. In this 2 day study, subjects will be asked to drink with 1 oz or 16 oz of water in the morning followed a few hours later by 16 oz water while the blood pressure is monitored. On the 2nd day, the other dose of water will be given to start, with 16 oz again as the second dose.

Eligibility Criteria:
Inclusion Criteria:

* orthostatic hypotension (fall in BP\>20/10 mmHg)
* pressor response to water in other studies
* Age 18-80 years

Exclusion Criteria:

* pregnancy
Use of Thalidomide in Chronic Uveitis

This research study is for patients that have been diagnosed with chronic uveitis, a disease that causes inflammation in the eye. Patients are currently being treated with Remicade, Humira, Methotrexate and or similar chemotherapy type drugs to control this inflammation. Despite these medications, patients still have inflammation in their eyes. Patients are being asked to add an additional drug, thalidomide.

Patients will be in the study for approximately 24 weeks. The visits are at screening, baseline (week 0), and weeks 4,8,12, and 24.

The purpose of this research study is to see if Thalidomide is safe and effective in the treatment of patients with chronic inflammation in their eyes. Thalidomide is approved by the Food and Drug Administration (FDA) for a leprosy skin condition, erythema nodosum leprosum (ENL). The drug works in many different ways, including as an anti-inflammation drug. Therefore, it is thought that this drug might be able to improve symptoms and lung function. At this time, the drug is not approved for use for uveitis.

Eligibility Criteria:
Inclusion Criteria:

* You are being asked to take part in this research study because you have been diagnosed with chronic uveitis, a disease that causes inflammation in the eye. You are currently being treated with Remicade, Humira, Methotrexate and or similar chemotherapy type drugs to control this inflammation. Despite these medications, you still have inflammation in your eyes. You are being asked to add an additional drug, thalidomide.

Exclusion Criteria:

* You will not participate in this research study if any of the following apply to you:

  * Pregnant
  * If you are a man or woman not willing to take adequate birth control measures comply with FDA-mandated S.T.E.P.S.â program. .
  * If you are a breast feeding woman
  * If you have a significant peripheral neuropathy (numbness or tingling in your hands or feet)
  * Have had a recent blood clot in your leg or lungs
  * If you are currently receiving biphosphonates such as zoledronic acid (fosamax)
A Study to Assess the Relative Bioavailability of Oral ABBV-932 in Healthy Adult Participants

This study will assess the relative bioavailability and effect of food on pharmacokinetics of ABBV-932 oral administration in healthy adult participants.


Eligibility Criteria:
Inclusion Criteria:

* Body Mass Index (BMI) ≥ 18.0 to ≤ 32.0 kg/m\^2 after rounding to the tenths decimal at the time of screening and upon initial confinement. BMI is calculated as weight in kg divided by the square of height measured in meters.
* A condition of general good health, based upon the results of a medical history, physical examination, vital signs, laboratory profile, and a 12-lead ECG

Exclusion Criteria:

* History of epilepsy, any clinically significant cardiac, respiratory (except mild asthma as a child), renal, hepatic, gastrointestinal, hematologic or psychiatric disease or disorder, or any uncontrolled medical illness.
* History of any clinically significant sensitivity or allergy to any medication or food.
Safety Study of LLF580 in Obese Volunteers

The purpose of the study is to evaluate the safety and tolerability of multiple doses of LLF580 administered subcutaneously over 3 months in obese subjects. In addition, the study will also determine early efficacy signals in various metabolic diseases associated with elevated triglycerides and/or obesity.


Eligibility Criteria:
Inclusion Criteria:

* Body mass index (BMI) within the range of 30 to 45 kg/m2, inclusive, with ethnic adjustment (≥27.5 kg/m2 for Asian individuals).
* Fasting triglyceride 150 - 500 mg/dL (1.69 - 5.65 mmol/L), inclusive, at screening.
* Able to communicate well with the investigator, to understand and comply with the requirements of the study.

Exclusion Criteria:

* History of hepatobilliary disease.
* Liver disease or liver injury as indicated by abnormal liver function tests.
* Chronic infection with Human Immunodeficiency Virus (HIV), Hepatitis B (HBV) or Hepatitis C (HCV).
* Fasting triglycerides greater than or equal to 500 mg/dL \[5.65 mmol/L\], or concomitant use of drug treatment for hypertriglyceridemia (fibrates, omega-3 fatty acids, nicotinic acid).
* History of pancreatic injury or pancreatitis.
* History of hypersensitivity to drugs of similar biological class, FGF21 protein analogue, or Fc fusion proteins.
* History of bone disorders or low vitamin D level.
* Contraindications to MRI.
* Change in body weight (more than 5% self-reported OR 5 kg self-reported change during the previous 3 months).
* Use of weight loss drugs.
* Enrollment in a diet, weight loss or exercise programs.
Pesticide Exposure Pathways for Farmworker Children

This project is aimed at better understanding how children living in agricultural environments are exposed to pesticides, and how such exposures can be prevented or reduced. The current project will characterize pesticide exposure pathways for children of farmworkers.

This project is aimed at better understanding how children living in agricultural environments are exposed to pesticides, and how such exposures can be prevented or reduced. Since 1991 our group has investigated pesticide expsoures among children of agricultural families in Washington state, focusing on exposure to organophosphate insecticides. We have demonstrated in these studies that the residential environments of agricultural families have higher pesticide residues than do other homes in this region. We have also found that children living in these residential environments have elevated levels of pesticide metabolites in their urine. We need to better understand how these children are being exposed in order to develop recomendations for exposure prevention or reduction. The current project will characterize pesticide exposure pathways for children of farmworkers. A complementary project is also underway by the UW-Child Health Center to develop and implement a community-wide intervention to reduce the transfer of pesticides from the workplace to the home (take home pathway).

Eligibility Criteria:
Each family recruited must include one child between the ages of 1-5.
Demographic , Clinicopathological Characteristics and Survival of Breast Cancer

The investigators will retrospectively study the demographic , clinicopathological characteristics and survival of breast cancer patients admitted to Assiut University hospital from the year 2015 to 2019

Breast cancer is one of the most common malignancies in females, which is the second leading cause of cancer death throughout the world after lung cancer . The incidence of breast cancer has been increasing over the past decades , especially in young women (≤ 35 years old). There is approximately 182,000 women with breast neoplasm annually in the United States, accounting for about 26% of all incident cancers among women.

In Asia, the morbidity rate is as high as 9.5%-12% . Even worse in China, the average onset age of breast cancer might be 8-10 years younger than that in Western countries which account for upto 4% in total breast cancer patients .

In Egypt, breast cancer is the commonest type of female malignancy represented about 38.8% among common cancer sites in females.Although The unclear etiology of the majority of breast cancer, but there are numerous risk factors for the disease. Screening and early detection when combined with adequate, efficient treatment is considered the hope for a reduction of mortality in breast cancer as postulated by World Health organization (WHO).

Eligibility Criteria:
Inclusion Criteria:

* All histologically confirmed and documented patients with invasive ductal or lobular carcinoma of the breast attending at Assiut University hospital from year 2015 to 2019.

Exclusion Criteria:

* • Patients who previously received treatment outside Assiut University hospital.

  * A serious un controlled concomitant disease that would contraindicate with use of systemic treatment. .
Neoplasia Detection With Methylene Blue MMX Tablets in Patients With UC Undergoing Colonoscopy

Evaluation of the intraepithelial neoplasia detection rate in patients with long standing ulcerative colitis undergoing mucosal staining with oral methylene blue MMX tablets prior to colonoscopy.


Eligibility Criteria:
Inclusion Criteria:

* endoscopically verified UC signed written informed consent

Exclusion Criteria:

* Known or suspected GI obstruction or perforation Liver or renal impairment, malignancy, pregnancy or lactation, suppressed PT.
Double Trigger in Patients With Low Proportion of Mature Oocytes

The aim of this randomized controlled trial is to determine whether co-administration of GnRH agonist and hCG for final oocyte maturation ( 40 and 34 h prior to oocyte retrieval , respectively) can increase the number of mature oocytes in patients with history of low proportion of mature oocytes in previous IVF cycle triggered by HCG.


Eligibility Criteria:
Inclusion Criteria:

* Patients with history of low proportion of mature oocytes in previous IVF attempt (triggered by HCG).
* Patients with 6 to 15 mature follicles on the day oocyte trigger in the current IVF-ET attempt

Exclusion Criteria:

* Endometriosis
* PCOS
Diet and Exercise in Overweight Children Postburn

Examine clinical results of an interdisciplinary weight management program that includes medical evaluation, nutrition counseling, exercise, and behavioral interventions.


Eligibility Criteria:
Inclusion Criteria:

* 10-18 years old
* BMI \> or = 95th percentile
* \> 1 year postburn and out of pressure garments
* Live within 100 minle radius of SHC
* Informed consent and HIPPA form signed
* Parent/guardia willing to make time commitment

Exclusion Criteria:

* Undergone major surgery in the 4 months prior to start of program or have any major surgery planned in 2 year time frame
* Physical/health condition that precludes regular exercise
* Significant mental health diagnosis
* Advised by MD not to exercise
* Thyroid disease, routine steroid use,pregnancy
* Unable to understand the instructions/content of program
High Tea Consumption on Smoking Related Oxidative Stress

The overall objective of this study is to determine the effect of high tea consumption on biological markers of oxidative stress that mediate lung cancer risk.


Eligibility Criteria:
Inclusion Criteria:

* FEV1 \< 85% and at least 25 pack-years of current or former smoking history.
* No diagnosis of internal cancer within the last 5 years or no chemotherapy or radiation for an internal cancer within the last 5 years.
* Meets the Southwest Oncology Group (SWOG) performance status criteria of 0-1.
* Not be pregnant or intending to get pregnant during the study period (women participants).
* Willing to drink 4 cups of tea (each cup will be brewed with 2 tea bags and 12 ounces of water) for 1-month run-in period and for the 6-month intervention period.
* Willing to refrain from consuming other tea or tea products starting one month before the placebo run-in period and for the entire study period (a total of 8 months)
* Willing to refrain from consuming more than one caffeinated product (coffee, soda..) starting one month before the placebo run-in period and for the entire study period (a total of 8 months).
* Subjects cannot take mega-doses of vitamins during the trial. This is defined as more than 400 IU of vitamin E, 200 ug of selenium, or 1 gm of vitamin C per day, or more than the tolerable upper limits of any other supplement as defined in the Dietary Reference Intake panels developed by the Food and Nutrition Board under the Institute of Medicine. Such vitamin therapy must be discontinued at least 2 weeks prior to study entry.

Exclusion Criteria:

* Subjects immunosuppressed by virtue of medication or disease.
* Serious concurrent illness that could interfere with study regimen.
* Subjects with a history of invasive cancer within the past 5 years.
* Subjects who are drinking more than 5 cups of non-herbal tea per week.
* Subjects who cannot or are unwilling to consume caffeinated beverages.
* Subjects unable to perform forced expiratory maneuver during spirometry testing.
* More than one acute emphysema exacerbation within the last 6 month -period .
* Subjects on oxygen.
* Women with positive urinary pregnancy test.
A Study to Assess the Efficacy, Safety and Tolerability of Pregabalin in Patients With Symptoms of Neuropathic Pain

The objective of this study is to evaluate the efficacy, safety and tolerability for pregabalin using a flexible, optimized dose schedule compared to placebo in relieving the symptoms of neuropathic pain.


Eligibility Criteria:
Inclusion Criteria:

* Chinese outpatient of age 18 to 75
* At screening and baseline, a score of greater than 40 mm on the visual log scale of SF-MPQ

Exclusion Criteria:

* Neurologic disorders unrelated to neuropathic pain, which in the opinion of the investigator, might impair the assessment of pain
* Serum creatinine clearance greater than 60 ml/min
Education With Inhalers in Patients With COPD Exacerbation

Chronic obstructive pulmonary disease (COPD) is a public health problem with great morbidity. The main therapeutic strategy is inhalers. The objective of this study is to determine the efficacy of an educational intervention in the use of inhalers in patients with COPD including ventilatory re-education and video recordings of the patients themselves.

The importance of this pathology lies not only in its high prevalence, which is expected to increase due to the aging of society but also in its high mortality. In Europe, it is estimated that 50% of adult patients do not use the inhaler correctly. The clinical development of COPD includes periods of stability interspersed with symptomatic exacerbations, which usually involve hospitalization. During these hospitalizations, respiratory symptoms are worsening.Nevertheless, in Europe, it is estimated that 50% of adult patients do not use the inhaler correctly. Thus, it is very important the pharmacological education in this patients.

Eligibility Criteria:
Inclusion Criteria:

* Inclusion criteria were to be clinically diagnosed of exacerbation of COPD, to possess pharmacological treatment in the form of inhalers.

Exclusion Criteria:

* Exclusion criteria were inability to provide informed consent, presence of psychiatric or cognitive disorders, neurological disorders, organ failure, cancer or inability to cooperate. Patients who had experienced an exacerbation of prior COPD in less than one month were excluded.
Treatment-related Benefit and Satisfaction in Fabry Patients. Insight in Patients Expectations and Preferences

In the shared decision-making process, patients should express their expectations and preferences regarding treatment to the physician. A specific questionnaire addressing needs and expectations of Fabry patients has been built at the initiative of Amicus. In addition, this questionnaire also evaluates the benefit of treatment from the patient's perspective. Nothing is known until now on patient's expectations, potential clustering of patients regarding their expectations and evaluation of treatment benefit from the patients perspective.

Study objectives are differentiated according to the study phase (inclusion and follow-up). At inclusion, the primary objective is to cluster patients according to their needs and expectations regarding treatment. During follow-up, the primary objective is to evaluate treatment benefit in relation with patients needs and expectations.

Prospective, longitudinal, non-comparative, open-label, multicentre, non interventional cohort study.

Eligibility Criteria:
Inclusion Criteria:

* Patients ≥ 16 years old
* Diagnosed with Fabry disease
* With amenable mutation
* Decision by clinician to start or pursue ongoing ERT or migalastat
* Non-opposition form to participate in the study signed

Exclusion Criteria:

- Concomitant patient participation in an interventional clinical study (Category 1 interventional research or category 2 interventional research according to the Jardé law classification in France)
Comparison of Teriparatide With Alendronate for Treating Glucocorticoid-Induced Osteoporosis

Osteoporosis is a condition in which the amount of bone is reduced, the bones are weak, and there is an increased risk for fractures. Glucocorticoids (such as prednisone) are prescribed to treat a large number of conditions such as arthritis and asthma. When taken for several months or longer, glucocorticoids can cause bone loss and lead to a form of osteoporosis called "glucocorticoid-induced osteoporosis." This study compared the effects of teriparatide, the study drug, with alendronate, an approved drug for treating glucocorticoid-induced osteoporosis.


Eligibility Criteria:
Inclusion Criteria:

* Men or women age 21 years or older
* Taking on average 5.0 mg/day prednisone or equivalent for at least 3 months prior to screening

Exclusion Criteria:

* Taking bisphosphonates within past 6 months
* More than 30 micrograms/day of estradiol or equivalent in past 3 months
* History of alcoholism or drug abuse in past year
* Pregnant women or nursing mothers