cyrilzakka/clinical-trials huggingface dataset:
A Study of How Safe Abrocitinib (CIBINQO) is in Pregnant Women and Their Offspring

The purpose of this observational study is to learn about the safety of abrocitinib (CIBINQO) in pregnant women and the offspring.

The study is seeking participants who:

* Are currently or recently pregnant
* Receive at least one dose of CIBINQO at any time during pregnancy or prior to pregnancy OR have a diagnosis of moderate-to-severe atopic dermatitis

All participants in this study will receive treatment according to routine care, as this is an observational study. The exposed group will consist of pregnant women exposed to abrocitinib during pregnancy. The unexposed group will consistent of pregnant women with moderate-to-severe atopic dermatitis who are not exposed to abrocitinib during pregnancy.

The study will compare the experiences of pregnant women receiving abrocitinib to pregnant women who do not. This will help us determine if abrocitinib is safe during pregnancy.

Participants will take part in this study until their infant is 12 months of age. During this time, the participant's care will be managed no differently than if she was not taking part in this study. Data will be collected through a virtual research coordinating center at enrollment, the end of the second trimester, and pregnancy outcome (live birth or fetal loss). For live-born infants, data on the infants will be collected at 4 and 12 months of age. No additional visits beyond routine care will be required.


Eligibility Criteria:
Inclusion Criteria:

* Women of any age who are currently or recently pregnant (recently pregnant defined as enrollment within 1 year of pregnancy outcome)
* Consent to participate in this study and evidence of a personally signed and dated informed consent document indicating that the patient (or a legally acceptable representative) has been informed of all pertinent aspects of the study
* Authorization for her healthcare provider(s) to provide data to the registry
* Must receive at least one dose of CIBINQO at any time during pregnancy or prior to pregnancy (within 1 day prior to the date of conception) OR have a diagnosis of moderate-to-severe atopic dermatitis at any time prior to pregnancy outcome.

Exclusion Criteria:

* Participants will be excluded from the registry if they do not meet the inclusion criteria listed above.
Brain Lesion and Visuospatial Impairment in CP Child

Children with cerebral palsy (CP) show varying degrees of motor impairment and movement disorders whose perceptive-visual contribution has yet to be established. The literature reports that children with CP have more frequent neuro-visual disorders. The link between the location and size of the brain lesion and neurovisual symptomatology has yet to be explored.

In this retrospective clinical data study, we will investigate in children with PC whether there is an anatomo-clinical correlation between visuo-spatial disorders is the brain injury of interest to the dorsal visual pathway. We will explore the volume of grey and white matter parietal involvement.

To test visuo-spatial disorders, we will use the PVSE (Visuo-Spatial Elementary Perception) test which does not require motor skills or language and is therefore suitable for children with a PC. This test will make it possible to better identify the deficit or deficits in order to adapt an early remediation. It could serve as a reference for comparing several pathologies/etiologies.


Eligibility Criteria:
Inclusion Criteria:

* Male or female aged 4 to 18 yo
* With a CP diagnosis
* With PVSE test completion during his/her regular follow-up
* With a cerebral MRI scan during his/her regular follow-up

Exclusion Criteria:

- With an incomplete PVSE test or whose interpretation was deemed unreliable by the rater
Goal-directed Resuscitation in High-risk Patients Undergoing Cardiac Surgery

The primary aim of the study is to investigate whether a goal-directed resuscitation therapy in high-risk patients through cardiac index optimization using the LiDCO Rapid device reduces complications after cardiac surgery. The hypothesis is that there are better outcomes when achieving a cardiac index higher than 3L/min/m2 in those patients with an arterial lactate higher than 1.5 mmol/L.


Eligibility Criteria:
Inclusion Criteria:

* All elective primary and redo adult cardiac surgical patients for coronary artery bypass grafting, valve procedure or combined procedures
* Adults patients
* Written informed consent
* One of the following criteria:

  * EuroSCORE (European System for Cardiac Operative Risk Evaluation) higher than or equal to 6
  * Ejection fraction lower than 50%
  * Recent myocardial infarction
  * Unstable angina

Exclusion Criteria:

* Age less than 18 years
* Infectious endocarditis
* Transplant procedures
* Emergency procedures
* Pulmonary hypertension
* Preoperative cardiogenic shock or use of dobutamine
* Congenital procedures
* Need for intra-aortic balloon pump (IABP)
* Noradrenaline dose higher than 1mcg/kg/min
* Pregnancy
* Patients who refused participation in the study
HPV Self-test to Increase Cervical Cancer Screening in Asian Women

The study was to pilot test the feability of using HPV self-sampling testing to increase cervical cancer screening among under-served Asian women through engaging community-based organizations in the greater Philadelphia and New York City area, addressing a significant global cancer burden, the preventable infection-related cervical cancer.


Eligibility Criteria:
Inclusion Criteria:

1. gender: female
2. age: 30-55
3. no current diagnosis of cervical cancer, and
4. have not participated in cervical cancer screening within the past 3 years.

Exclusion Criteria:

-
Impact of Hormonal Therapy on Prostate Cancer Recurrence After Radical Prostatectomy

Prostate cancer is the most common cancer in men and radical prostatectomy is the most frequent treatment for this disease. Unfortunately, approximately 40% of patients will develop recurrence after surgery, requiring additional salvage radiation. Salvage radiation after recurrence is successful in less than half of these men and most of those die from their disease. Measures to prevent recurrence are an important research priority for prostate cancer patients and their families. Hormonal therapy (androgen deprivation therapy; ADT) is routinely used to treat patients with metastases, but few clinical trials have examined if adjuvant ADT after surgery will prevent cancer recurrence. We aim to address this research oversight and test the hypothesis that for men at high risk of cancer recurrence, 1 year of ADT immediately after surgery will be safe and will significantly improve cancer outcomes.


Eligibility Criteria:
Inclusion Criteria:

1. undetectable PSA (\<0.02 ng/ml) within 16 weeks post-operative;
2. ≥25% predicted risk of PSA recurrence within 5 years of surgery (based on the Kattan nomogram)

Exclusion Criteria:

1. Unwilling to receive ADT;
2. previously received ADT;
3. lymph node metastases
4. allergy to any form of ADT
Clinical Predictors of Apnea-hypopnea During Propofol Sedation

To relate two different predictive values of sleep apnea: the STOP score (snoring while sleeping, daytime tiredness, observed breathing stoppages, and high blood pressure) and the estimated respiratory disturbance index (eRDI) with the occurrence of apnea-hypopnea during propofol sedation,thirty four middle-aged male patients who underwent urologic surgery under spinal anaesthesia will be enrolled. Before surgery, patients will be asked to complete a STOP-questionnaire. The eRDI will be calculated using the modified Mallampati's grade, tonsil grade, and the body mass index. After performing spinal anaesthesia, propofol will be infused and adjusted to BIS 70-75. An ApneaLinkTM, which measures airflow through a nasal cannula, will be then applied to estimate the level of apnea-hypopnea.

The investigators will evaluate correlation between STOP scor and AHI(apnea hypopnea index) or eRDI and AHI. After then the investigators will compare AHI severity between high risk group and low risk group subgrouped according to STOP score or eRDI.

Eligibility Criteria:
Inclusion Criteria:

* Thirty four males who underwent spinal anaesthesia for transurethral resection of the bladder (TURB) or prostate (TURP) were enrolled in this studyInclusion criteria were American Society of Anaesthesiologists (ASA) physical status of 1-2, and ages of more than 40 years.

Exclusion Criteria:

* Patients with electrocardiographic or simple chest radiographic abnormalities or who had taken medication that could affect their sleep patterns were excluded.
A Trial to Investigate the Impact of a Low Glycemic Index (GI) Diet on Body Mass Index and Obesity Related Cardiovascular and Hormonal Factors in Chinese Adolescents

Epidemiological studies suggest a role for a low glycemic index (GI) diet in the management of obesity and associated metabolic risks including diabetes. However, evidence from long-term, randomized controlled trials exploring the relationship between low GI diet, weight reduction and glycemia, particularly in children and adolescents, is lacking. Modern food-processing technology has produced many food products with high GI which may contribute to the burgeoning epidemic of obesity worldwide. Since dietary habits are shaped in early life, adolescence is a critical period to educate our young people to acquire a healthy eating habit to prevent obesity.

The investigators hypothesized that, in Chinese adolescents, low GI diet results in greater reduction in body mass index and body fat percentage, enhanced insulin sensitivity and favorable changes of cardiometabolic risk factors compared to conventional diet after 12 months of intervention.

This study is a randomized controlled trial of a low GI (\<55) versus conventional Chinese diet (GI\>/=70) in adolescents (12-month intervention followed by a 6-month observational period) to study; 1) the changes in body mass index and obesity associated changes in cardiometabolic profile; 2) the underlying hormonal factors associated with these changes.

This is a 12-month randomized controlled dietary interventional trial followed by a 6-month observational period. The objectives of this study include:

1. To study changes of body mass index, body fat percentage, insulin secretion, insulin resistance and obesity associated cardiometabolic factors;
2. To explore underlying neurohormonal mechanisms associated with these changes in both short- and long-term.

Eligibility Criteria:
Inclusion Criteria:

* Age between 15 and 18 years (inclusive)
* Male or female of Chinese ethnicity
* Body mass index \>/= 95th percentile of Hong Kong local age- and sex-specific reference
* No major medical illness
* Not on any chronic medications
* Post-pubertal as ascertained by clinical assessment by endocrinologist
* Willingness to give written informed consent by participants and his/her parents/guardian

Exclusion criteria:

* Concurrent participation in any clinical trial, dietary intervention or weight loss program
* Concomitant intake of weight reducing agent
* Active and uncontrolled endocrine diseases including hypo- or hyperthyroidism, Cushing's syndrome, diabetes mellitus, etc.
* Significant renal impairment, defined as serum creatinine \>150 umol/L and/or estimated glomerular filtration rate \<60ml/min/1.73m2
* Significant liver impairment, defined as \>2 times upper limit of alanine aminotransferase and asparate aminotransferase levels
* Gastrointestinal problems that would prevent them from following the test diets
* Active malignant disease
* Pregnant or lactating
* Any medical illness or condition including known non-compliance, as judged by the investigators as ineligible to participate the study
A Study to Determine the Efficacy of ZPL-3893787 in Subjects With Atopic Dermatitis

This was a randomized, double blind, placebo controlled, parallel group study in approximately 90 subjects with moderate-severe AD Eczema Area and Severity Index (EASI) ≥12 and ≤ 48 (0-72 scale). Following a run-in subjects were randomized to receive either oral 30 mg ZPL-3893787 once daily (od) or placebo od for 8 weeks (56 days).


Eligibility Criteria:
Inclusion Criteria:

Males and females aged 18-65 years inclusive with physician documented history or diagnosis of atopic dermatitis for at least 12 months prior to screening. Chronic AD should be diagnosed by the Eichenfield revised criteria of Hanifin and Rajka (Eichenfield, 2004)

Eczema Area and Severity Index (EASI) of ≥12 and \<48.

An Investigator's Global Assessment (IGA) score ≥ 3 at both Screening and Day 0.

A mean pruritus score of ≥ 5 on a 0-10 scale over the 7 day Run In (Days -7 to -1)

Atopic dermatitis affecting ≥10% BSA

Exclusion Criteria:

AD of such severity (EASI \>48) that the subject could not comply with the demands of the study and/or the subject is not a suitable candidate for a placebo-controlled study

Have concurrent skin disease (e.g. acne) of such severity in the study area that it could interfere with the study evaluation or presence of skin comorbidities that may interfere with study assessments.

Have an active skin infection or any other clinically apparent infections.

Hypersensitivity to mometasone or to any other ingredients contained by the topical corticosteroid product used as rescue medication in the study.

Have received phototherapy (e.g. UVA, UVB), or systemic therapy (e.g. immunosuppressants, cytostatics) known or suspected to have an effect on AD, within 4 weeks of the start of the Run In.

Have received systemic corticosteroids (\[CS\] e.g. oral, intravenous, intraarticular, rectal) within 4 weeks of the start of the Run in. Subjects on a stable maintenance dose (over the preceding 3 months) of inhaled or intranasal CS may participate.

Were treated with oral antihistamines or topical calcineurin inhibitors or topical steroids within 7 days of starting Run In; intranasal antihistamines for the treatment of allergic rhinitis are acceptable.
Impact Of Nutritional Education Program In Hemodialysis Patients

The study aims to improve the health status of chronic renal failure patients on hemodialysis using nutritional education program on quality of life anserum d electrolytes level by application of physical and clinical evaluation and some biochemical analysis before and after a specified nutritional program

The function of kidney is to control many biological mechanism such as fluid , electrolyte

, PH balance , blood pressure , excretion of toxins and waste , vitamin D and hormonal synthesis . Chronic kidney disease is referred to as " The silent killer " because it often goes undiagnosed due to lack of apparent symptoms. Hemodialysis is life saving treatment in ESRD patients and prolongs life expectancy .

Hemodialysis is a process where the patient"s blood is passed through a dialysis venous catheter via a dialysis fluid solution in a hemodialysis machine to be filtered externally then returned to the patient . Hemodialysis therapy is usually associated with large number of morbidities . However, the inception of hemodialysis is linked with a decrease in functional status among elderly.

As many patients undergoing regular hemodialysis treatment suffer from protein-energy wasting which causes the patient to lose one-three kilos of lean body mass per year, losing body mass is associated with reduction of the overall well being and activity of the patient .

This is associated with worsening of the nutritional status and consequently increase hospitalization and mortality among those patients undergoing regular hemodialysis treatment . Many studies recommended to use both physical and nutritional therapy in order to enhance the outcome and experience of patients on hemodialysis .

The aim of the study:

The study aims to improve the health status of chronic renal failure patients on hemodialysis using nutritional education program on quality of life and serum electrolytes level by application of physical and clinical evaluation and some biochemical analysis before and after a specified nutritional program

Eligibility Criteria:
Inclusion Criteria:

* hemodialysis patients whatever diabetic or hypertensive
* underweight patients

Exclusion Criteria:

* patients diagnosed CKD not on hemodialysis treatment
* patients with malignancy
* patients refuse to participate
* patients age over than 60 years or below 18
* patients with malignancy
* patients refuse to participate
Earlier Mobilization Post Acute Thrombectomy

This is a phase III trial trying to determine whether 12-hour bed rest following thrombectomy for ischemic stroke is non-inferior to 24-hour bed rest by measure of outcomes on the modified Rankin Scale (mRS) at 90 days post bed rest.


Eligibility Criteria:
Inclusion Criteria:

* Age 18 years or older
* Received thrombectomy (may have also received intravenous tPA) for a diagnosis of acute ischemic stroke
* TICI 2b/2c/3 score following thromectomy
* Patient and/or Legally Authorized Representative provide consent

Exclusion Criteria:

* TICI 0/1/2a score following thrombectomy
* Venous thromboembolism present at symptom onset
* Pneumonia present at symptom onset
* STEMI at symptom onset
* Positive troponins at symptom onset according to local values
* Bone fracture at symptom onset
* Intubation anticipated or occurred
* Symptomatic intracranial hemorrhage (defined as increase in NIHSS by 4 points or more accompanied by PH2 hemorrhage on imaging) at the time of screening.
* Pre-screening systolic blood pressure \< 110 mmHg
* Resting pulse oximetry \< 92% (with or without supplemental oxygen)
* Neurological worsening (defined as NIHSS increase of 4 points compared to initial score) prior to screening.
* Baseline modified Rankin Scale score \> 2
* Known Pregnancy
* Patient not anticipated to survive 3 months
* Patient not anticipated to follow-up at 3 months
A Study of the Use of Combination of Anti-cholinergic and Minor Tranquilliser in the Treatment of Non-cardiac Chest Pain - a Double Blind Placebo Controlled Study

Non-cardiac chest pain is a common clinical problem encountered in our practice but at present, the results of treatments are unsatisfactory. The pathogenesis remains unknown but altered motility of the esophagus and psychological factors including anxiety have been implicated as important factors. Reports of the single use of anticholinergic drugs and anxiolytics have yielded conflicting results, has been demonstrated to yield marginal or of no value. However the use of the combination therapy, especially with a double blind fashion have not been reported. On that basis, we propose to use a combination of anti-cholinergic and tranquilliser for the symptomatic treatment of non-cardiac chest pain. The aim of this study is to evaluate the efficacy of combination therapy of anti-cholinergic and anxiolytic drugs in the treatment of non-cardiac chest pain.


Eligibility Criteria:
Inclusion Criteria:

* Ambulatory patients over the age of 18
* Patients who are normal endoscopically
* Patients who do not have symptomatic reflux disease
* Patient who have normal coronary angiogram or patient with normal exercise radionuclide scan or patient with normal persantin radionuclide scan.

Exclusion Criteria:

* Patients with history of significant cardiac, renal, pulmonary or hepatic diseases,
* Patients with history of dyspepsia or peptic ulcer diseases
* Patient with documented reflux diseases.
* Patient on drugs that affect gastrointestinal motility in the past 2 weeks
* Patients who are pregnant or lactating
* Patients who are suffering from costochrondritis
* Patients who are known to be sensitive to benzodiazepine or anti-cholinergic
* Patients with glaucoma and benign prostatic hypertrophy
Vasopressor Infusion in Cesarean Delivery

Comparison will be conducted between continuous variable infusions of both drugs (Phenylephrine and Norepinephrine) with starting doses of 0.75 mcg/Kg/min and 0.1 mcg/Kg/min respectively for prophylaxis against Post-spinal hypotension during cesarean delivery.

Maternal hypotension is a common complication after spinal anesthesia for cesarean delivery (CD). Many vasopressors have been used for prevention of post-spinal hypotension (PSH) during CD; however, the optimum protocol for prophylaxis is not established yet. Phenylephrine (PE) is a popular vasopressor used in obstetric anesthesia; however, its use is limited by its marked cardiac depressant nature. Norepinephrine (NE) is a potent vasopressor characterized by both α adrenergic agonistic activity in addition to a weak β adrenergic agonistic activity; thus, NE is considered a vasopressor with minimal cardiac depressant effect; these pharmacological properties would make NE an attractive alternative to PE. In this study, we will compare continuous variable infusion of both drugs (PE and NE) with doses of 0.75 mcg/Kg/min and 0.1 mcg/Kg/min respectively for prophylaxis against PSH during CD.

Eligibility Criteria:
Inclusion Criteria:

* full term
* pregnant women
* scheduled for cesarean section

Exclusion Criteria:

* pre-ecpamsia
* eclampsia
* bleeding
* cardiac dysfuction
An Organoid-based Functional Precision Medicine Trial in Osteosarcoma

The purpose of this study is to examine if we can predict sensitivity of osteosarcoma to different chemotherapy agents using tissue cultures in the laboratory. We know that different chemotherapy agents can be used in the treatment, but not every sarcoma responds to them equally. It is important to understand if testing of the tissue obtained during a routine biopsy or surgery may be useful in selecting appropriate treatments. In addition, additional testing of the tumor, including genetic testing, will help us to understand osteosarcoma better.

Investigators successfully established a miniaturized system that allows the setup of hundreds of wells and perform assays with minimal manipulation. The adapted geometry used to plate tumor cells in Matrigel, to generate mini-rings around the rim of the wells. This is attained by plating single-cell suspensions obtained from a cell line or a surgical specimen pre-mixed with cold Matrigel in a ring shape around the rim in 96-well plates. Rings can be established using a single-well or multichannel pipette. Cancer cell lines grown in mini-ring format give rise to organized tumor organoids that recapitulate features of the original histology. Treatment protocols and readouts for the mini-ring approach have been optimized. Seeding cells takes place on day 0, 2-3 days are allowed to establish organoids and it is followed by two consecutive daily drug treatments. The assay is flexible and can be easily adapted to single treatments followed by longer incubations, multiple consecutive recurring treatments, multi-drug combinations, or other screening strategies. Assays were implemented to quantify drug response by measuring cell viability after staining of live organoids with specific dyes followed by imaging. The pipeline has been extended to sarcomas: the team characterized organoids established from over 120 sarcoma biopsies, resections, and metastasectomies. Sarcoma organoids showed patient-specific growth characteristics and subtype-specific histopathology. Organoid sensitivity correlated with diagnostic subtype, patient age at diagnosis, lesion type, prior treatment history, and disease trajectory for a subset of the compounds screened. Organoid screening can provide information to facilitate optimal drug selection, avoid ineffective therapies, and mirror patient outcomes in sarcoma.

Eligibility Criteria:
Inclusion / exclusion criteria - Group1:

- Patients without diagnosis of osteosarcoma and whose imaging studies are suggestive of osteosarcoma and who are planned to undergo biopsy or surgery for diagnostic purposes

Inclusion / exclusion criteria - Group 2:

- Patients whose imaging studies are suggestive of metastatic osteosarcoma and who are planned to undergo biopsy or surgery for diagnostic purposes