cyrilzakka/clinical-trials huggingface dataset:
Gemcitabine in Treating Patients With Recurrent or Refractory Cancer of the Uterus

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase II trial to study the effectiveness of gemcitabine in treating patients with recurrent or refractory cancer of the uterus.

OBJECTIVES: I. Determine the antitumor activity of gemcitabine in patients with recurrent or persistent leiomyosarcoma of the uterus who failed higher priority treatment protocols. II. Determine the toxicity of gemcitabine in these patients.

OUTLINE: Patients receive gemcitabine IV over 30 minutes weekly for 3 weeks. Courses repeat every 4 weeks in the absence of unacceptable toxicity and disease progression. Patients with partial response, complete response, or stable disease receive at least 3 courses of therapy. Patients are followed every 3 months for 2 years, then every 6 months for 3 years.

PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study within 4 years.

Eligibility Criteria:
DISEASE CHARACTERISTICS: Histologically confirmed recurrent or persistent uterine leiomyosarcoma that is refractory to curative therapy or standard treatments Failed local therapeutic measures and considered incurable Measurable disease Not eligible for a higher priority GOG protocol

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: GOG 0-2 Life expectancy: Not specified Hematopoietic: WBC at least 3,000/mm3 Platelet count at least 100,000/mm3 Granulocyte count at least 1,500/mm3 Hepatic: Bilirubin no greater than 1.5 times normal SGOT no greater than 3 times normal Alkaline phosphatase no greater than 3 times normal Renal: Creatinine no greater than 1.5 mg/dL Other: No significant infection At least 5 years since any other invasive malignancy except nonmelanoma skin cancer

PRIOR CONCURRENT THERAPY: Biologic therapy: At least 3 weeks since prior biologic therapy Chemotherapy: At least 3 weeks since prior chemotherapy and recovered No prior gemcitabine No more than 1 prior chemotherapy regimen (single agent or combination therapy) Endocrine therapy: At least 3 weeks since prior endocrine therapy Radiotherapy: At least 3 weeks since prior radiotherapy and recovered Surgery: At least 3 weeks since prior surgery and recovered
Trial of Pemetrexed for Patients With Pancreatic Cancer Which Cannot be Treated With Surgery or is Metastatic

This study with pemetrexed is for patients with metastatic or unresectable pancreatic cancer who progressed after first line chemotherapy with gemcitabine.


Eligibility Criteria:
Inclusion Criteria:

* Histological or cytological diagnosis of adenocarcinoma of the pancreas that is locally advanced (Stage II, III) or metastatic (Stage IV), as staged by the American Joint Committee on Cancer (AJCC; Protocol Attachment S041.2; Fleming et al. 1997), and not amenable to resection with curative intent.
* Prior systemic first line chemotherapy with gemcitabine single agent or a combination regimen including gemcitabine (not more than one prior systemic chemotherapy allowed).
* Uni-dimensionally measurable disease according to the RECIST criteria (Therasse et al. 2000), defined as: At least one lesion that can be accurately measured in at least one dimension, with the longest diameter greater than or equal to 2 cm with conventional techniques or greater than or equal to 1.0 cm with spiral CT scans. Ultrasound and X-ray are NOT allowed to measure or follow lesions.

Exclusion Criteria:

* Prior radiation of equal to or greater than 25% of the bone marrow (Cristy and Eckerman 1987)
* Prior immunotherapy, biological therapy, and/or hormonal therapy for pancreas cancer.
* Prior systemic chemotherapy with 5-FU.
* Patient not yet recovered from the acute toxic effects of the treatment prior to study enrollment.
* Radiotherapy within the last 4 weeks before study entry
Comparison of Oral and Nasal Tube Feeding on Stroke-related Dysphagia

This was a prospective multicenter study. the patients after stroke with were randomly divided into the observation group and the control group. All patients were given comprehensive rehabilitation therapy. During the treatment, enteral nutrition support was provided for the two groups by Intermittent Oro-esophageal tube feeding and nasogastric tube feeding, respectively. Nutritional status, dysphagia, quality of life and depression before and after treatment were compared.

Dysphagia in patients after stroke continues to be a challenge. To avoid the wound caused by gastrostomy, nasogastric tube feeding has been the mainstay of palliation, but potential side effects exist this choice. Intermittent Oro-esophageal tube feeding is an established modality that can be used with comprehensive rehabilitation therapy. This study reports the outcomes of Intermittent Oro-esophageal tube feeding and comparison with nasogastric tube feeding, including nutritional status, dysphagia, quality of life, depression, and follow-up in patients receiving comprehensive rehabilitation therapy.This was a prospective multicenter study. the patients after stroke with were randomly divided into the observation group and the control group. All patients were given comprehensive rehabilitation therapy. During the treatment, enteral nutrition support was provided for the two groups by Intermittent Oro-esophageal tube feeding and nasogastric tube feeding, respectively. Nutritional status, dysphagia, quality of life and depression before and after treatment were compared.

Eligibility Criteria:
Inclusion Criteria:

* age ≥ 18 years;
* meeting the diagnostic criteria of stroke;
* any degree of dysphagia at admission;
* steady vital signs, without severe cognitive impairment or sensory aphasia, able to cooperate with the assessment.
* transferred out within three weeks of hospitalization in the neurology department.

Exclusion Criteria:

* complicated with other neurological diseases;
* damaged mucosa or incomplete structure in nasopharynx;
* tracheostomy tube plugged;
* unfeasible to the support of parenteral nutrition;
* simultaneously suffering from liver, kidney failure, tumors, or hematological diseases.
Home Based Clinical Management of Interstitial Lung Disease in Systemic Rheumatic Diseases

The RMD-mILDer trial is a home monitoring strategy trial aiming to improve management of interstitial lung disease related to rheumatic diseases applying eHealth technology.

It is planned as a 2 arm 54 week multi-centre randomised controlled trial to assess outcome of home monitoring with bi-weekly serial forced vital capacity- and patient reported outcome-measurements compared to standard of care with fixed-interval hospital visits in adult patients with rheumatic disease associated interstitial lung diseases.


Eligibility Criteria:
Inclusion Criteria:

* Systemic rheumatic disease (Systemic sclerosis (SSc), rheumatoid arthritis (RA), idiopathic inflammatory myopathies including antisynthetasis syndromes (IIM), mixed connective tissue disease (MCTD) or Sjøgrens disease (SjD)) classifiable by disease-specific classification criteria
* Diagnosed interstitial lung disease (ILD) on high resolution computed tomography (HRCT) ≥ 1 year prior to randomization, not explained by other diseases or exposures
* On stable standard of care treatment 6 months prior to randomization
* Participants must be able to understand and follow trial procedures including completion of questionnaires regarding Patient Reported Outcome measures
* Participants must have access to the internet, and experience in using smartphones or other electronic devices with internet access
* Signed informed consent form

Exclusion Criteria:

* Severe heart failure with ejection fraction (EF) \< 30%
* Chronic renal failure G4 or more (defined by KDIGO) with glomerular filtration rate (eGFR) \< 30 mL/min using Cockroft-Gault formula.
* End stage lung disease with forced vital capacity (FVC) \< 50% and/or diffusion capacity for carbon monoxide (DLCO) \< 40% or coexisting severe other lung diseases (e.g. chronic obstructive pulmonary disease, emphysema)
* Airway obstruction (pre-bronchodilator FEV1/FVC \< 0.7) (FEV1 is defined as forced expiratory volume in 1 sec)
* In the opinion of the investigator, other clinically significant pulmonary abnormalities
* Significant pulmonary hypertension defined by the following: Previous clinical or echocardiographic evidence of significant right heart failure OR history of right heart catheterization showing a cardiac index \</= 2 L/min/m2 OR pulmonary hypertension requiring therapy with epoprostenol/treprostinil
* Active treatment for cancer or non-curable cancer
* Relative contraindications to performing spirometry, as specified in ATS/ERS guidelines.
* Ongoing Prednisolone ≥ 20 mg/day at inclusion
* Unable to speak, write and read Norwegian, German or Romanian in the respective country of inclusion.
* Unable to perform good quality measurements of FVC on the home-device comparable to results on an in-hospital device, after training.
* Pregnancy or planned pregnancy
Optimizing Left Ventricular Lead To Improve Cardiac Output

The purpose of this study is to determine if optimal lead placement, guided by the largest improvement in aortic flow measured by Doppler will:

1. Improve the way the heart's left ventricle functions
2. Decrease the number of hospital admissions for heart failure related symptoms
3. Reduces uncoordinated heart contractions
4. Improve quality of life as measured by the Minnesota Living with Heart Failure Questionaire and NYHA Class assessed after six months

The hypothesis of this study determines if response to CRT therapy could be improved by optimizing LV lead position at the time of the left ventricular pacing lead implantation. This optimization (using a Doppler wire) would alter the left ventricular activation pattern and contraction mechanics. This increase in contractility may improve the likelihood of mid/long term response to therapy. This study will compare 6-month response to CRT (left ventricular ejection fraction, decrease in left ventricular end systolic and end diastolic dimensions and volumes) in heart failure patients.

The secondary objective will be to:

1. To determine if optimal lead placement, guided by the largest improvement in stroke volume, results in a greater 6-month improvement in clinical QOL and NYHA class.
2. Acutely compare and/or correlate intra-operative A-V and V-V timing optimization via invasive pressure volume data to post-operative echo optimization of these same parameters.
3. Acutely contrast changes in stroke volume during pacing from several different left ventricular lead locations.

Eligibility Criteria:
Inclusion Criteria:

* Clinical indication for CRT-P or CRT-D
* QRS Duration\>=120 MSEC
* Left Ventricular Ejection fraction\<=35%
* NYHA Class III-IV
* History of Cardiomyopathy, least one month post MI, or at least six months old in case of non-ischemic cardiomyopathy
* At least 18 years of afe

Exclusion Criteria:

* Previous implanted CRT-P/CRT-D
* woman who are pregnant
* Psychological or emotional problems
The Renin-Aldosterone Axis in Postural Tachycardia Syndrome

The purpose of this study is to determine the role of the renin-angiotensin-aldosterone in the pathophysiology of postural tachycardia syndrome, and to provide an insight about the disease process in this disorder.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of postural tachycardia syndrome by the Vanderbilt Autonomic Dysfunction Center criteria
* Age between 18-64 years
* Male or females are eligible
* Able and willing to provide informed consent
* Healthy control subjects with no major medical problem (including postural tachycardia syndrome), free of medications during the study

Exclusion Criteria:

* Overt cause of postural tachycardia e.g., dehydration
* Inability to give or withdraw informed consent
* Pregnancy
* Hypertension (BP \> 140/90)
* Significant co-morbid condition
* Other factors which in the investigator's opinion would prevent the subject from completing the protocol
Pelacarsen Roll-over Extension Program

This non-randomized, rollover extension study will provide post-trial access to pelacarsen (TQJ230) to participants who have successfully completed either of the double-blind parent studies (CTQJ230A12303 or CTQJ230A12304).

This study will evaluate long-term safety and tolerability of pelacarsen (TQJ230) 80 mg Once a month (QM) in patients with elevated Lp(a) and established ASCVD. All consenting participants from the parent study who meet the eligibility criteria will be participating in this open label extension study.

Eligibility Criteria:
Inclusion Criteria:

* Participants who have provided informed consent prior to initiation of any study-specific activities/procedures.
* Participants who have completed the parent study and received the assigned study treatment at the time of its completion

Exclusion Criteria:

* Participants who permanently discontinued the study treatment as mandated per protocol or due to adverse events in the parent study
* Any medical condition(s) in the investigator's opinion that may put the participant at risk or interfere with the study participation
* Participants who are receiving another investigational drug or device before the open-label treatment period
* Participants who have a known sensitivity to the study drug and are deemed as unsuited for the study by the investigator

Other protocol-defined inclusion/exclusion criteria may apply.
Etiology, Epidemiology and Prognostics of Acute Kidney Injury (AKI)

* To investigate the etiology, epidemiology and prognostic factors of acute kidney injury.
* To find out risk factors that relate with the prognosis of acute kidney injury,focusing on inflammation, oxidative stress and nutritional status.
* To study on the relationship between gene polymorphism and prognosis of acute kidney injury.

1. to investigate the relationship between preexisting malnutrition and adverse outcomes in patients with AKI

   - Several nutritional assessment methods such as anthropometric, clinical and biochemical evaluations have been used; however, no single indicator is considered to be a "gold standard."
2. to evaluate the association of serum nutritional variables and prognosis of acute kidney injury
3. Given the different half-lives of serum nutritional markers, we hypothesized that the utility of serum nutritional variables as prognostic predictors may differ in early death (\<7 days) and late death (\>7 days, \<28 days) patients.

Eligibility Criteria:
Inclusion Criteria:

* age \>=16 years and \<= 88 years
* clinically diagnosed with acute kidney injury, according RIFLE or KDIGO criteria.

Exclusion Criteria:

* acute Renal Failure occurring in the setting of burns, obstructive uropathy, allergic interstitial nephritis, acute or rapidly progressive glomerulonephritis, vasculitis, hemolytic-uremic syndrome, thrombotic thrombocytopenic purpura (TTP), malignant hypertension, scleroderma renal crisis, atheroembolism, functional or surgical nephrectomy, hepatorenal syndrome, cyclosporin or tacrolimus nephrotoxicity
* Do Not Resuscitate (DNR) status
* subjects enrolled in another clinical trial that could affect the outcome of this study protocol
A Comparison of Kidney Function After Nephrectomy in Living Donors Under Sevoflurane and Desflurane Anesthesia

Living-donor kidney transplantation has been considered as the best treatment for patients with end-stage renal disease (ESRD). Kidney donation from living donors has been performed widely under their noble humanity and a belief that donation would not harm the donor. Although the overall evidences proposed that living kidney donor have medical outcomes similar to those in general population, several reports have demonstrated the potential risks for development of hypertension, proteinuria, and ESRD. Thus, all efforts should be concentrated on ensuring their safety and preserving the function of their remained kidney during anesthesia maintenance.

Inhaled anesthetics have been frequently used for the induction and maintenance of general anesthesia. The metabolism of certain inhaled anesthetics can produce inorganic fluoride, which may be directly nephrotoxic through impairments of renal concentrating ability. The typical inhaled anesthetics commonly used nowadays are sevoflurane and desflurane. The defluorination of sevoflurane can results in increased serum inorganic fluoride ion concentrations, but any neprhotoxic effect of sevoflurane has not been proven yet in human. On the other hand, desflurane is extremely resistant to defluorination, and desflurane does not appear to be nephrotoxic.

The inhaled anesthetics which are currently used in general anesthesia have no clinical evidence of nephrotoxicity, but the possible risks cannot be excluded entirely, especially in the patients who one kidney is donated. The purpose of the current retrospective, single center study was to evaluate and compare postoperative renal function of living kidney donor after nephrectomy under sevoflurane or desflurane anesthesia, and make evidence-based recommendations of proper inhaled anesthetics for anesthesia of living kidney donor.


Eligibility Criteria:
Inclusion Criteria:

* donors who went through nephrectomy for kidney donation under general anesthesia with sevoflurane or desflurane

Exclusion Criteria:

* donors who went through nephrectomy for kidney donation under general anesthesia with other inhaled anesthetics except sevoflurane and desflurane
Timing of Target Enteral Feeding in the Mechanically Ventilated Patient

This study tests the hypothesis that initial trophic enteral feedings will increase the time alive and free of mechanical ventilation as compared to initial goal enteral feedings in patients who are mechanically ventilated.

Mechanically ventilated patients, within 48 hours of initiating mechanical ventilation, are randomized in a 1:1 fashion to receive trophic enteral feedings for 96 hours followed by advancement to goal feeding rates or initial advancement to goal feeding rates. Primary endpoints are ventilator free days, ICU-free days, gastrointestinal intolerances, development of nosocomial infections, and mortality.

Eligibility Criteria:
Inclusion Criteria: Patients will be eligible for inclusion in the study if they meet the following criteria:

* Mechanical ventilation expected to last at least 72 hours.
* Presence of, or primary physician's intent to place, an enteral feeding tube and begin enteral feeds.

Exclusion Criteria:

* More than 48 hours elapsed since both inclusion criteria met.
* Patient, legal representative, or physician refuses consent or is unavailable to provide consent.
* Patient, legal representative, or physician not committed to full support (Exception: A patient will not be excluded if he/she would receive all supportive care except for attempts at resuscitation from cardiac arrest).
* Presence of malignant or irreversible condition and estimated 28 day mortality greater than 50%.
* Severe or refractory shock.
* Moribund patients not expected to survive 24 hours from start of enteral feeding (as determined by primary medical team).
* Child-Pugh score greater than 10.
* Presence of partial or complete mechanical bowel obstruction, or ischemia, or infarction.
* Current TPN use or intent to use TPN within 7 days.
* Severe malnutrition with BMI less than 18.5 and/or loss of more than 30% total body weight in the previous 6 months.
* Neuromuscular disease impairing the ability to ventilate spontaneously.
* Laparotomy expected within 7 days.
* Unable to raise head of bed 45°.
* greater than 30% total body surface area burns.
* Absence of GI tract/short bowel syndrome - defined as entire length of small bowel totaling 4 feet or less.
* Presence of high-output (\> 500 cc/day) enterocutaneous fistula.
* Age less than 13 years
* Allergy to enteral formula
Effectiveness of a Brief Intensive Trauma Treatment for Adolescents With (s)PTSD: a Multi-center RCT

The primary objective of this study is to examine the effectiveness of a Brief Intensive Trauma Treatment (BITT) for adolescents with (s)PTSD.

This study is a multi-center, single-blinded RCT. Adolescents (12-18 years old) with (s)PTSD will be randomly allocated by an independent researcher to the BITT (n=50) versus a waitlist control group (WLCG; n=50), stratified by center. Measurements are done at comparable time intervals for both groups: at pre-treatment (T0), directly after BITT or WLCG (T1) and at 3 (T2), 6 (T3) and 9 (T4) months follow-up. The WLCG receives BITT after the 3 months follow-up.

Eligibility Criteria:
Inclusion Criteria:

In order to be eligible to participate in this study, a subject must meet all of the following criteria:

* 12-18 years of age;
* with a history of psychological trauma (conform the Life Events Checklist of the Clinician Administered PTSD Scale for Children and Adolescents DSM-5 (CAPS-CA DSM-5) (Nader, 2004; van Meijel et al., 2019);
* at least subthreshold PTSD criteria, conform the CAPS-CA DSM-5, i.e.;

  * fully meeting criterion A, F and G and at least one symptom of criteria B, C, D and E;
  * or fully meeting criterion A, F, G and at least the B, C, D or E symptom clusters;
* and written informed consent must be provided by the adolescent and, for adolescents aged 12-15 years, all legal guardians.

Exclusion Criteria:

A potential subject who meets any of the following criteria will be excluded from participation in this study in case of:

* inability to speak and write Dutch;
* estimated or determined mental retardation (IQ \<70);
* suffering from ongoing trauma by a parent who is part of the adolescent's current primary-care system.
Surgical Management of Optic Disc Pit Maculaopathy

To evaluate the anatomical and functional results of pars plana vitrectomy (PPV) combined with internal limiting membrane (ILM) peeling, endolaser photocoagulation and gas tamponade in management of optic disc pit (ODP) maculopathy.

As it is well known, optic disc pit (ODP) is a rare congenital disease which is usually associated with maculopathy (ODP-M) in the form of intraretinal and subretinal fluid accumulation at the macular area leading to visual impairment.

With no definite treatment and absence of guidelines for its management, the invistigators considered their prospective, interventional case series to evaluate the anatomical and functional results of pars plana vitrectomy (PPV) combined with internal limiting membrane (ILM) peeling, endolaser photocoagulation and gas tamponade in management of optic disc pit (ODP) maculopathy.

Eligibility Criteria:
Inclusion Criteria:

* Patients included in this study are those with ODP associated with macular detachment

Exclusion Criteria:

* Exclusion criteria included patients unfit for general anesthesia, those with insufficient clear media to perform the surgery with ILM peeling and those with other ocular diseases that can affect central macular thickness (CMT) and the best corrected visual acuity (BCVA).
Drusen Morphology Changes in Nonexudative Age-related Degeneration After Oral Antioxidants Supplementation

Purpose: To determine drusen morphology (volume and area) changes in nonexudative age-related macular degeneration (AMD) after one year of oral supplementation with AREDS-like formulation.

Methods: Patients with AREDS category 2 and 3 AMD were prospectively enrolled in this study, and were randomized to receive daily oral supplementation with lutein (12mg) + zeaxanthin (2mg) + astaxanthin (8mg) + omega-3 fatty acids (docosahexaenoic acid \[DHA\] 540mg + eicosapentaenoic acid \[EPA\] 360mg) + vitamin C (40mg) + vitamin E (20mg) + zinc (16mg) + copper (2mg), or observation during one year. ETDRS vision, biomicroscopy, intraocular pressure (IOP), color fundus photography and automatic measurement of drusen with Topcon 3D-OCT 2000 (Topcon, Tokyo, Japan) using the 6 x 6 mm 3D cube scan protocol, were performed in all patients, at baseline and 12 months after. Automated delineation of macular drusen was modified by the investigators when evident segmentation errors occurred.

Eligibility Criteria:
Inclusion Criteria:

* AREDS category 2 and 3 AMD

Exclusion Criteria:

* AREDS category 4 AMD
* other ophthalmological diseases
* currently on antioxidant supplementation