cyrilzakka/clinical-trials huggingface dataset:
Decision Making in Serious Pediatric Illness

This study will look at a cohort of parents whose children are confronting life-threatening illnesses in intensive care, palliative care, and complex care settings, to test whether parents with higher levels of hopeful patterns of thinking are subsequently more likely a) to change the "level of care" order status of their child (as an important and demonstrable example of adapting goals); b) to reprioritize goals for the child when they are reassessed regarding goals ; and c) to report a higher degree of achieving self-defined 'good parent' attributes.

Parents making medical decisions for a child living with a life-threatening condition confront, sometimes repeatedly, an extremely daunting task: how to decide when to set aside the therapeutic goal of cure or of life prolongation and instead prioritize the goals of comfort or quality of life.

This study will look at a cohort of parents whose children are confronting life-threatening illnesses in intensive care, palliative care, and complex care settings, to test whether parents with higher levels of hopeful patterns of thinking are subsequently more likely a) to change the "level of care" order status of their child (as an important and demonstrable example of adapting goals); b) to reprioritize goals for the child when they are reassessed regarding goals ; and c) to report a higher degree of achieving self-defined 'good parent' attributes.

We hypothesize that parents with higher levels of hopeful patterns of thinking subsequently will be:

More likely to enact a limit of intervention order. More likely, upon explicit formal reassessment, to reprioritize goals for the child.

More likely to report a higher degree of achieving self-defined 'good parent' attributes.

Eligibility Criteria:
Inclusion Criteria:

* Parents of children who are patients at The Children's Hospital of Philadelphia (CHOP) admitted to the neonatal, pediatric, or cardiac intensive care unit (NICU, PICU, or CICU), or who have been referred to the Pediatric Advanced Care Team (PACT) for palliative care services. A patient is eligible when the patient's attending physician considers it likely that parents will have major treatment decisions to make for their child within the coming 12 to 24 months.

Exclusion Criteria:

* Non English-speaking parents
Treatment of IgAN With Multi-glycoside of Tripterygium Wilfordii HOOK. f.

The purpose of this study is to determine whether Multi-glycoside of Tripterygium Wilfordii HOOK. f. is effective and safe in the treatment of IgA nephropathy.

Primary IgA nephropathy (IgAN) is the most common form of idiopathic glomerulonephritis throughout of the world. The disease is characterized by the predominant deposition of polymer Gal-deﬁcient IgA1 immune complex（pGd-IgA1-IC）in the glomeruli which leads to the proliferation of mesangial cells. Mycophenolate mofetil is reported to be useful in the treatment of IgAN in Chinese patients, but the price is expensive together with some adverse events. Tripterygium Wilfordii HOOK. f. is a traditional chinese medicine and is useful in the treatment of CKD, the purpose of this study is to determine whether Multi-glycoside of Tripterygium Wilfordii HOOK. f. is effective and safe in the treatment of IgA nephropathy

Eligibility Criteria:
Inclusion Criteria:

* urinary protein levels ≥1.0 g/24 h
* estimated glomerular filtration rate (eGFR) ≥30 ml·min-1·1.73 m-2body surface area by the MDRD formula (eGFR=194×age-0.287×serum creatinine
* 1.094(×0.739, if female) (where sCr is the serum creatinine, dry chemistry method, mg/dl))
* peripheral blood white blood cell count ≥3000×109/L
* no other cause for tubulointerstitial lesions
* no history of immunomodulatory agent intake before renal biopsy
* no systemic infection
* age between 16 and 65 years

Exclusion Criteria:

* severe infections
Devitalized Non-valved Pulmonary Artery Allograft Implant for the Repair of Congenital Cardiac Abnormalities

Study no longer required


Eligibility Criteria:
Pentostatin Followed by Peripheral Stem Cell Transplantation in Treating Patients With Advanced Kidney Cancer

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining chemotherapy with donor peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells.

PURPOSE: Phase I/II trial to study the effectiveness of pentostatin followed by peripheral stem cell transplantation in treating patients who have advanced kidney cancer.

OBJECTIVES:

* Determine the duration and efficiency of hematopoietic and immunologic engraftment in patients with advanced renal cell carcinoma treated with pentostatin followed by related allogeneic stem cell transplantation.
* Determine the hematologic and non-hematologic toxic effects of this regimen in these patients.
* Determine the incidence and severity of graft-versus-host disease in patients treated with this regimen.

OUTLINE: This is a dose-escalation study of pentostatin.

* Phase I: Patients receive pentostatin IV on days -7, -5, and -3 followed by allogeneic stem cell transplantation on day 0. Beginning on day 1, patients receive filgrastim (G-CSF) IV over 1 hour or subcutaneously daily until blood counts recover. As graft-versus-host disease prophylaxis, patients receive cyclosporine IV continuously until stem cell engraftment and then orally with gradual tapering.

Cohorts of 3 to 6 patients receive escalating doses of pentostatin until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which 2 of 6 patients experience dose-limiting toxicity.

* Phase II: Patients receive treatment as in phase I at the MTD for pentostatin. Patients are followed weekly for 60 days and then monthly for 10 months.

PROJECTED ACCRUAL: A total of 24 patients (12 per phase) will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Histologically confirmed advanced renal cell cancer
* No bone metastases
* No CNS disease
* Must have an allogeneic donor available

PATIENT CHARACTERISTICS:

Age:

* Over 18

Performance status:

* ECOG 0-1

Life expectancy:

* 3 to 6 months

Hematopoietic:

* Hemoglobin at least 10 g/dL
* Complete blood count normal

Hepatic:

* Bilirubin no greater than 3 times upper limit of normal (ULN)
* Transaminases no greater than 4 times ULN
* No evidence of portal hypertension

Renal:

* Creatinine no greater than 2.0 mg/dL
* No uncontrolled hypercalcemia

Cardiovascular:

* No New York Heart Association class 3 or 4 heart disease

Pulmonary:

* DLCO at least 40% of predicted

Other:

* No severe functional neurological impairment
* HIV negative
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

* No more than 1 prior biologic therapy

Chemotherapy:

* No more than 6 months of prior chemotherapy

Endocrine therapy:

* At least 1 year since prior steroids

Radiotherapy:

* Not specified

Surgery:

* Not specified
REVEAL 2 Trial (Evaluation of VGX-3100 and Electroporation for the Treatment of Cervical HSIL)

HPV-303 is a prospective, randomized, double-blind, placebo-controlled study of VGX-3100 delivered intramuscularly (IM) followed by electroporation (EP) delivered with CELLECTRA™ 5PSP in adult women with histologically confirmed high-grade squamous intraepithelial lesions (HSIL) (cervical intraepithelial neoplasia grade 2 \[CIN2\] or grade 3 \[CIN3\]) of the cervix, associated with human papillomavirus (HPV-16) and/or HPV-18.


Eligibility Criteria:
Inclusion Criteria:

* Women aged 18 years and above
* Confirmed cervical infection with HPV types 16 and/or 18 at screening
* Cervical tissue specimen/slides provided to Study Pathology Adjudication Committee for diagnosis scheduled to be collected within 10 weeks prior to anticipated date of first dose of study drug
* Confirmed histologic evidence of cervical HSIL at screening
* Must be judged by Investigator to be an appropriate candidate for the protocol-specified procedure required at Week 36
* With respect to their reproductive capacity must be post-menopausal or surgically sterile or willing to use a contraceptive method with failure rate of less than 1% per year when used consistently and correctly from screening until Week 36
* Normal screening electrocardiogram (ECG)

Exclusion Criteria:

* Microscopic or gross evidence of adenocarcinoma-in-situ (AIS), high grade vulvar, vaginal, or anal intraepithelial neoplasia or invasive cancer in any histopathologic specimen at screening
* Cervical lesion(s) that cannot be fully visualized on colposcopy
* History of endocervical curettage (ECC) which showed cervical HSIL indeterminate, or insufficient for diagnosis
* Treatment for cervical HSIL within 4 weeks prior to screening
* Pregnant, breastfeeding or considering becoming pregnant during the study
* History of previous therapeutic HPV vaccination
* Immunosuppression as a result of underlying illness or treatment
* Receipt of any non-study, non-live vaccine within 2 weeks of Day 0
* Receipt of any non-study, live vaccine within 4 weeks of Day 0
* Current or history of clinically significant, medically unstable disease or condition which, in the judgment of the investigator, would jeopardize the safety of the participant, interfere with study assessments or endpoint evaluation, or otherwise impact the validity of the study results
* Presence of acute or chronic bleeding or clotting disorder that would contraindicate IM injections, or use of blood thinners within 2 weeks of Day 0
* Participation in an interventional study with an investigational compound or device within 30 days of signing informed consent
* Less than two acceptable sites available for IM injection
Metformin and Esomeprazole For Preterm Pre-eclampsia

A recent randomized controlled trial by Cluver et al included 180 women with preterm pre-eclampsia between 26+0 to 31+6 weeks' gestation undergoing expectant management: 90 were randomised to extended release metformin and 90 to placebo. Investigators found that extended release metformin (3g daily) can prolong gestation in women with preterm pre-eclampsia. Combination metformin and esomeprazole has shown promise in the treatment of preeclampsia as both agents reduce placental and endothelial secretion of soluble fms-like tyrosine kinase 1 (sFlt-1) and soluble endoglin, and reduce endothelial dysfunction.


Eligibility Criteria:
Inclusion Criteria:

Individuals presenting with pre-eclampsia between 24+0 and 31+6 weeks of gestation, with a single viable fetus and no major anomalies

* Women 18 years or older
* Women diagnosed with preeclampsia
* Women with pre-eclampsia superimposed on chronic hypertension
* Candidates for expectant management and had no clinical indication for immediate delivery

Exclusion Criteria:

* Delivery within 48hr is highly likely
* Maternal or fetal compromise that necessitated immediate delivery
* Diabetes or gestational diabetes currently on metformin therapy
* Contraindications to metformin, esomeprazole
* Baseline creatinine \>124 μmol/L
* Hypersensitivity to metformin or esomeprazole
* Metabolic acidosis
* Use of drugs that might interact with metformin (glyburide, furosemide, or cationic drugs) Multiple gestations
Timing of Carbetocin Administration in Postpartum Hemorrhage

Postpartum haemorrhage (PPH) is one of the major contributors to maternal mortality and morbidity worldwide. Active management of the third stage of labour has been proven to be effective in the prevention of PPH. Syntometrine is more effective than oxytocin but is associated with more side effects. Carbetocin, a long-acting oxytocin agonist, appears to be a promising agent for the prevention of PPH. The use of carbetocin, being an important agent in the prevention of PPH, also increases its prevalence. It is planned to investigate the advantages and disadvantages of the timing of its use.


Eligibility Criteria:
Inclusion Criteria:

* Singleton pregnancy
* Vaginal delivery at or beyond 38 weeks of gestation
* Primipar

Exclusion Criteria:

* Multiparity
* Contraindications to carbetocin use (e.g., pre-existing hypertension, pre-eclampsia,asthma, cardiac, renal, or liver disease)
* High-risk factors for primary postpartum hemorrhage, including grand multiparity,presence of uterine fibroids, or a need for prophylactic oxytocin infusion
* Anemia or
* body mass index (BMI) over 35
* Baby weight over 4000 grams
* Comorbidities or chronic diseases
* History of curettage
* Use of propess or oxytocin during labor
The Neural Correlates of Food Choice Decision-making in Obesity and Weight Loss

This study is designed to determine whether obese, normal weight, and successful weight loss maintainers differ in their food choice decision-making and/or executive function, and whether participation in a behavioral weight loss program leads to neural and/or behavioral changes. The investigators will examine behavioral performance on several tasks involving decision-making and self-control in conjunction with brain imaging data acquired during a food-choice decision-making task. Participants enrolled in the behavioral weight loss program will also be assessed following the treatment.


Eligibility Criteria:
Inclusion Criteria:

* women, ages 35-55, who are either currently obese (BMI = 30-40 kg/m2), always normal weight (lifetime BMI \< 25, NW) or successful weight loss maintainers who have lost 10% of their body weight and maintained that loss for at least 1 year (lifetime maximum BMI = 30-40 kg/m2)

Exclusion Criteria:

* weight loss medications, binge eating, standard MRI contraindications (e.g., metal implants, claustrophobia, pregnancy), left-handedness, food allergies, neurological or psychiatric conditions, including but not limited to schizophrenia, bipolar disorder, epilepsy, stroke and traumatic brain injury with loss of consciousness, and, among obese participants, inability to participate at two time points and lack of interest in participating in a behavioral weight loss trial
* serious current physical disease (e.g., heart disease and cancer) for which physician supervision of diet and exercise prescription is needed, physical problems that limit the ability to exercise, participation in a weight loss program in the last 2 months and intention to become pregnant in the next 6 months
Virtual A2 Study for At Risk Children

The goal of this behavioral-interventional study is to learn if the Abecedarian Approach implemented virtually for children ages 0-5 with a history of Hypoxic Ischaemic Encephalopathy (HIE) and/or premature birth produces the same effects as when administered at in-person facilities.


Eligibility Criteria:
Inclusion Criteria:

1. IPNH-NDCP patients, including:

   * Term-born children diagnosed during the neonatal period with hypoxic-ischemic encephalopathy, or
   * premature children (born at less than 28 weeks gestational age).
2. Parent or legal guardian will also be enrolled as a participant
3. Parents must be English-speaking (able to provide consent and complete questionnaires).

Exclusion Criteria:

1. Not suitable for study participation due to other reasons at the discretion of the investigator.
2. Infants with chromosomal abnormalities, genetic syndromes (for example, such as Down Syndrome or Trisomy18) and major congenital malformations will be excluded.
3. Infants with vision impairment will also be excluded from the study, as our study procedures do require intact vision to be able to complete.
4. For parents or legal guardians, there are no exclusion criteria.
Diabetes Study With Rosiglitazone Monotherapy Versus Metformin Or Glyburide/Glibenclamide

The study will compare and evaluate the effects of long-term treatment of monotherapy with rosiglitazone, metformin and glyburide/glibenclamide on the improvement and maintenance of glycemic control in patients with recently diagnosed type 2 diabetes mellitus.


Eligibility Criteria:
Inclusion criteria:

* Newly diagnosed patients (\< 3years) with type 2 diabetes.
* Fasting plasma glucose (FPG) range of 126-240 mg/dL at Screening.
* No previous treatment with oral or parenteral glucose-lowering therapy.

Exclusion criteria:

* History of lactic acidosis.
* Anemia (\<11g for males, \<10 g for females).
* Unstable or severe NY Heart Association-class 3 or 4.
* Any NY Heart Association congestive heart failure.
* Patients with chronic diseases requiring periodic or intermittent treatment with oral or intravenous corticosteroids.
Performance of Red Tinted Contact Lenses on Colour Defects

This study aimed to relate and compare the performance of 4 types of red-tinted contact lenses (CL) with the Total Error Score (TES) from the Farnsworth-Munsell 100 Hue test on colour deficient subjects. Only 6 subject with colour vision defect was tested in this study.

Six congenital CVD subjects were recruited. After colour vision screening using Ishihara plate, the Farnsworth-Munsell 100 Hue test was carried out to determine the type and severity of colour vision deficiency. Four types of red-tinted CL (Type A, B, C and D) were used. The performance of each of these lenses was determined through the comparison of error scores in the Ishihara test before and after wearing tinted contact lens on only the non-dominant eye. Then, the transmittance of each tinted CL was determined using a spectrophotometer. All these lenses were fitted on the subjects in one day where the subjects were given a 30-minute break for each intervention.

Eligibility Criteria:
Inclusion Criteria:

* Age range 18-40 years
* all sex
* color defect diagnosed with Ishihara Test
* no contraindication in contact lens wear

Exclusion Criteria:

* have ocular and systemic diseases
Clinical Outcomes of Patients with a Light Adjustable Lens (LAL) in At Least One Eye

To collect data on bilateral pseudophakic patients implanted with the RxSight Light Adjustable Lens (LAL) in at least one eye


Eligibility Criteria:
Inclusion Criteria:

* Adults with bilateral pseudophakia who have been implanted with the LAL in at least one eye and who have completed LDD light treatments

Exclusion Criteria:

* Visually significant eye disease
A Study Evaluating The Absorption Of Varenicline Into The Body From A Varenicline Solution And A Varenicline Patch Applied To The Skin

To evaluate the absorption, safety, and tolerability of a varenicline solution and a varenicline patch applied to the skin.

Additional Study Purpose Details: Evaluation of the pharmacokinetic profile of a varenicline solution and a varenicline patch applied to the skin

Eligibility Criteria:
Inclusion Criteria:

* healthy, adult, male smokers

Exclusion Criteria:

* significant medical illness
Evaluation of Automatic Oxygen Flow Titration During Walking in Patients With COPD

The aim of the current study was to evaluate a new system (FreeO2) that automatically titrates oxygen flow to maintain stable SpO2, in patients with moderate or severe chronic obstructive pulmonary disease during exercise. The investigators hypothesized that continuous automatic adjustment of the oxygen flows during exercise would better maintain patients within the oxygenation target, reduce episodes of desaturation and hyperoxia and would improve walking exercise tolerance in comparison with fixed levels of low-flow oxygen and with compressed air breathing.


Eligibility Criteria:
Inclusion Criteria:

* Patients older than 40 years
* Moderate to severe COPD according to the Global Initiative for Chronic Obstructive Lung Disease guidelines
* Who did not require long-term oxygen therapy were included in the study.
* Patients were also selected on the basis of known (end-exercise SpO2 \< 90% on a previous exercise test) or suspected (SpO2 \< 95% at rest) desaturation during exercise

Exclusion Criteria:

* Episode of exacerbation or hospitalisation within last four weeks
* Current medical condition that could influence exercise tolerance
H. Pylori Eradication on Healing of Iatrogenic Gastric Ulcer by Endoscopic Mucosal Resection

This study will evaluate the effect of Helicobacter pylori eradication therapy on the healing of iatrogenic gastric ulcer caused by endoscopic mucosal resection of gastric neoplastic lesions and is a multicenter, randomized, double blind, and placebo controlled trial.


Eligibility Criteria:
Inclusion Criteria:

* 30 - 75 years old
* Early gastric cancer (\< 3 cm in size, mucosa confined, differentiated type) or gastric adenoma (\< 3 cm in size)
* Helicobacter pylori positive

Exclusion Criteria:

* Medication of anti-secretory drugs (proton pump inhibitors, H2-receptor antagonists, antacid, bismuth compound)
* History of Helicobacter pylori eradication
* History of gastric surgery or other cancers
* Major comorbidities
* Medication of ASA, NSAIDS, steroids, anti-coagulants
Comparison of 2 Strategies of Adjustment of Mechanical Ventilation in Patients With Acute Respiratory Distress Syndrome

The aim of this multicenter randomized controlled trial is to compare the impact on mortality of patients mechanically ventilated for acute lung injury or acute respiratory distress syndrome of two strategies for setting end-expiratory pressure.

Most patients suffering from acute lung injury or acute respiratory distress syndrome require mechanical ventilation. In this setting, positive end-expiratory pressure is used to improve arterial oxygenation. While the beneficial effect on clinical outcome of using low tidal volume is clearly proven, the best way to titrate PEEP is not known. Higher PEEP levels may better improve oxygenation and reduce ventilator-induced lung injury by reducing end-expiratory alveolar collapse but may also cause circulatory depression and aggravate lung injury from end-inspiratory overdistension. This trial compares the impact on outcome of two strategies for setting PEEP. In the "minimal alveolar distension" arm, PEEP is set for a total PEEP (PEEP + intrinsic PEEP) between 5 and 9 cm H20). In the "maximal alveolar recruitment" arm, PEEP is set for a plateau pressure between 28 and 30 cm H20. A tidal volume of 6 ml/kg predicted body weight is used in the two arms. The goals for arterial oxygenation and PaCO2 are the same in the two arms.

Eligibility Criteria:
Inclusion Criteria:

* Mechanical ventilation through an endotracheal tube
* Bilateral infiltrates consistent with pulmonary edema
* PaO2/FiO2 \< 300 mmHg
* No clinical evidence of left atrial hypertension. If measured, pulmonary artery occlusion pressure \< 18 mmHg
* Criteria 1, 2 et 3 jointly present for less than 48 hours
* Written informed consent obtained from the patient or surrogate

Exclusion Criteria:

* Age \< 18 years
* Pregnancy
* Expected duration of mechanical ventilation through an endotracheal tube \< 48 hours
* Participation in other trials within the previous 30 days
* Increased intracranial pressure
* Severe chronic respiratory disease
* Morbid obesity (weight \> 1kg/cm)
* Sickle cell disease
* Bone marrow transplant or chemotherapy-induced neutropenia
* Extended burns (\> 30 % total body surface area)
* Severe chronic liver disease (Child-Pugh score C)
* Pneumothorax