cyrilzakka/clinical-trials huggingface dataset:
Study of Erlotinib and Chemotherapy for Unresectable or Metastatic Cancer of the Esophagus and Gastric Cardia

In this study, Erlotinib and 5-Fluorouracil (5-FU), Leucovorin and Oxaliplatin (a regimen known also as FOLFOX-6) will be the chemotherapy study drugs. The main purpose of this study is to test the safety and effectiveness of this combination of chemotherapy drugs and to see how they affect your cancer.

Another purpose of this study is to examine samples from your blood and tumor. This research will be done to better understand how subjects respond to treatment. Specifically, researchers will look at the way your genes and proteins respond to drugs like those used in this study.


Eligibility Criteria:
Inclusion Criteria:

1. Metastatic or unresectable adenocarcinoma of the upper gastrointestinal tract that can be measured in at least one dimension according to RECIST criteria by CT or MRI
2. Gastric adenocarcinomas may be included if the primary tumor arises within 5 cm of the anatomic gastro-esophageal junction (distal esophagus) or from the gastric cardia as indicated by either endoscope or imaging.
3. Previously untreated with chemotherapeutic agents for unresectable or metastatic disease.
4. Adjuvant chemotherapy and/or radiotherapy are allowed as long as no oxaliplatin was used in the past 12 months.
5. ECOG performance status 0 or 1
6. Age \> 18 years old.
7. Life expectancy greater than 6 months.
8. Peripheral neuropathy: must be \< grade 1
9. Absolute neutrophil count \> 1,500/mm3
10. Hemoglobin \> 9.0 g/dl
11. Platelet count \> 100,000/mm3
12. Hepatic Function:

    1. Total Bilirubin \< or = to 1.5 x ULN
    2. AST and ALT must be \< or = to 3.0 x ULN (\< or = to 5.0 x ULN if there is liver metastasis).
13. Creatinine clearance of \> 60 ml/min as calculated by the Cockcroft Gault formula. (Ccr = ((140-Age) X Wt (kg))/ (72 X SCr (mg/100ml) for males).

    (Ccr = ((140-Age) X Wt (kg))/ (72 X SCr (mg/100ml) x 0.85 for females)
14. Women of childbearing potential must have a negative pregnancy test by urine or serum testing.
15. Men and women of childbearing potential must be willing to consent to using effective contraception while on treatment and for at least 4 months after the last treatment.
16. Patients must have signed IRB approved informed consent
17. Patients must have the ability to comply with study and follow-up procedures.

Exclusion Criteria:

1. Patients with known hypersensitivity to any components of oxaliplatin, leucovorin, 5-fluorouracil (or other fluoropyrimidines) or erlotinib.
2. Women who are breast-feeding or pregnant.
3. Presence of \> Grade 2 neuropathy
4. Patients with prior malignancy other than non-melanoma skin cancer or cervical carcinoma in situ within the past five years
5. Current or prior history of central nervous system or brain metastases
6. Any other medical conditions, which, in the opinion of the investigator, would preclude subjects to participate in the study.
7. Patients who have received chemotherapy, surgery or radiation therapy within 30 days prior to the first dose.
8. INR greater than 3.5 for patients on warfarin
9. Known HIV infection
Penn Biobank Return of Research Results Program

The overall goal of the proposed research is to assess the feasibility of a randomized study evaluating the non-inferiority of an electronic Health (e-Health) delivery alternative (e.g. private web portal) as compared to return of actionable genetic research results with a genetic counselor.


Eligibility Criteria:
Inclusion Criteria:

1. Consented participant in University of Pennsylvania Biobank who previously submitted a DNA sample for research testing
2. English speaking
3. Aged 18 years or older
4. Agreed to be re-contacted in the future or did not indicate a preference on future contact regarding research results
5. Have an actionable mutation or have been selected as a control participant
6. Have not previously received actionable results of clinical genetic testing

Exclusion Criteria:

1. Deceased assessed by electronic medical record, death index or identified after contact
2. Evidence in the electronic medical record that the subject has already received the same actionable result through clinical genetic testing
A Comparison of Two Different Single Doses of Prednisolone on Endodontic Inter-appointment Pain

The purpose of this prospective randomized, double-blind, placebo-controlled study is to compare the efficiency of 2 different single doses of pre-operative oral prednisolone (20 \& 40 mg) for the control of inter-appointment endodontic pain in patients diagnosed with symptomatic irreversible pulpitis. The tested null hypothesis is that there is no difference in pain relief between the two doses.

Seventy-two patients presented for treatment at Dental University Hospital will be selected. The inclusion criteria are systemically healthy patients (ASA classification I or II), with no contraindications to corticosteroids (osteoporosis, systemic fungal infections, poorly controlled insulin-dependent diabetes mellitus, ocular herpes simplex, primary glaucoma, allergy to corticosteroids, ulcerative colitis, a compromised immune status, and major psychosis). Patients under 18 years, pregnant or breast-feeding, took an analgesic agent within the last 6 hours, those with un-restorable teeth, teeth with periodontal disease will be excluded. Patients having mandibular molars with symptomatic irreversible pulpitis with normal periapical area and moderate-severe preoperative pain (i.e. ≥ 34 mm on a visual analog scale (VAS)) will be included.

Subjects will be randomly divided into 3 groups, namely placebo (control), 20 mg prednisolone and 40 mg prednisolone according to a computerized random numbers. Each participant will receive a single oral dose of either formulation (drug or placebo) 30 minutes before starting endodontic treatment. All medications will be placed in identical containers and will be coded; thus, both the operator and the patients will be blinded to the type of medication. Endodontic treatment will be performed and canals will be instrumented to a minimum of size 30, .04 taper following the standardized protocol. Postoperative pain will be assessed by using a visual analogue scale at 4, 12, 24 and 48 hours after initiation of therapy.


Eligibility Criteria:
Inclusion Criteria:

* Systemically healthy patients (ASA classification I or II), with no contraindications to corticosteroids (osteoporosis, systemic fungal infections, poorly controlled insulin- dependent diabetes mellitus, ocular herpes simplex, primary glaucoma, allergy to corticosteroids, ulcerative colitis, a compromised immune status, and major psychosis).

Exclusion Criteria:

* Patients under 18 years, pregnant or breast-feeding, took an analgesic agent within the last 6 hours, those with un-restorable teeth, teeth with periodontal disease
Long Term Follow Up to Evaluate DTX301 in Adults With Late-Onset OTC Deficiency

Determine the long-term safety of DTX301 following a single intravenous (IV) dose in adults with late-onset ornithine transcarbamylase (OTC) deficiency.

Study 301OTC02 is a long-term follow-up study to evaluate the safety and efficacy of adeno-associated virus (AAV) serotype 8 (AAV8)-mediated gene transfer of human OTC in adults with late-onset OTC deficiency. Only subjects who complete Study 301OTC01 (NCT02991144) are eligible to participate in Study 301OTC02.

Eligibility Criteria:
Inclusion Criteria:

1. Completed the Week 52 visit in Study 301OTC01.
2. Willing and able to provide written informed consent.
3. Willing, able, and committed to comply with scheduled study site visits, study procedures, and requirements.

Exclusion Criteria:

1. Planned or current participation in another interventional clinical study that may confound the efficacy or safety evaluation of DTX301 during the duration of this study.
2. Any clinically significant medical condition that, in the opinion of the investigator, would pose a risk to subject safety or would impede the study.
Validation of 5-Point Investigator Global Assessments for Pemphigus

This study aims to explore the reliability and validity of newly developed Investigator Global Assessments (IGAs) in scoring the severity of pemphigus. IGAs are simple 5-point scales ranging from clear - severe and are preferred by the FDA as endpoints in clinical trials.

This study aims to obtain statistical data regarding the inter-rater and intra-rater reliability of the IGAs, Pemphigus Disease Activity Index (PDAI) and Autoimmune Bullous Skin Disease Intensity Score (ABSIS) as well as the convergent validity of the IGAs with the PDAI and objective component of the ABSIS.

Photograph sets of pemphigus lesions will be gathered from the lead site and participant sites. They will be de-identified and printed in a two hardcopy booklets; the first containing 20 photo sets and the second containing 17 new photo sets and 3 repeat photo sets. In the first part of the study, 8 dermatologists will score 20 sets of photographs of pemphigus lesions (a mixture of skin and mucosal lesions), using the IGAs for pemphigus as well as the PDAI and ABSIS. The first booklet will be mailed to dermatologists and they will use the booklet to score each photo set and will submit their scores in a confidential online survey. In the second part of the study, the second booklet will be sent to dermatologists in the same manner 4 weeks later, and each dermatologist will score the photo sets using the same scoring tools. It is estimated that each scoring session will take two hours to complete. Data gathered here will allow for calculation of inter-rater reliability and intra-rater reliability of the IGAs and convergent validity of the IGAs with PDAI and ABSIS.

Later, a sub-study will occur to calculate minimal clinically important differences (MCID) for the IGAs and PDAI. This will involve scoring pemphigus severity of patients at Premier Specialists using PDAI and IGA scores and a Likert score to classify patients as improved, stable or deteriorated compared to previous visits.

Eligibility Criteria:
Inclusion Criteria:

* Having pemphigus diagnosed by a qualified dermatologist
* Aged 18 or older at the time of photography

Exclusion Criteria:

* Those whose photographs are unable to be adequately de-identified
Coagulation Factors and Postpartum Hemorrhage

Objective is to analyze a possible association of coagulation factors peripartal with the occurrence of postpartum hemorrhage.


Eligibility Criteria:
Inclusion Criteria:

* pregnant women \> 22 weeks of gestation

Exclusion Criteria:

* age \< 18 years, no informed consent
Breath Synchronized Abdominal Muscle Stimulation to Facilitate Ventilator Weaning: a Pilot Study

The primary objective of this study is to determine whether neuromuscular electrical stimulation applied to the abdominal wall muscles in synchrony with exhalation can increase the strength of the respiratory muscles in prolonged mechanical ventilation patients.

In the U.S. over 500,000 patients have difficulty weaning from mechanical ventilation every year. These patients cost the health care system $16 billion annually and have an increased risk of medical complications and morbidity.

A major factor responsible for weaning failure is the imbalance between decreased respiratory muscle strength and excessive respiratory load. This study includes an investigational device that applies electrical stimulation to the abdominal muscles in synchrony with exhalation. This is hypothesized to improve the strength of the respiratory muscles. The long term goal of this project is to determine whether this approach can reduce the number of days taken for patients to wean from mechanical ventilation.

Eligibility Criteria:
Inclusion Criteria:

* Patients who have been mechanically ventilated for at least fourteen days.
* Clinically stable: oxygen saturation \> 90% with a fractional inspired oxygen ≤ 0.40, external positive end expiratory pressure ≤ 5 centimeters water, temperature ranging from 35.5 to 38.5 degrees celsius, no intravenous administration of vasoactive agents.

Exclusion Criteria:

* Patients in whom Neuromuscular Electrical Stimulation (NMES) does not elicit a palpable contraction of the abdominal muscles.
* Patients with broken or irritated skin on the abdominal wall
* Patients with a history of neuromuscular disease
* Body Mass Index (BMI) \> 35 kg/m2
* Patients who are not medically stable
* Patients with a pacemaker
* Female patients who are pregnant
* Patients under the age of 18
* Patients who are expected to die within four weeks
* Patients who are unable to follow verbal instructions
* Patients with epilepsy
* Patients with an abdominal wall hernia
* Patients with anoxic encephalopathy
* Patients with history of, or active, substance abuse
Effects of Structured Group Education on Quality of Life and Glycemic Control in Type 1 Diabetes

Patients with type 1 diabetes aged 15-65 years without major complications will be randomized either to usual care or to a structured group education program, with 6 four-hour weekly interactive sessions devoted to diabetes management. The principal endpoint will be the variation of HbA1c at 12 months from enrolment. Secondary endpoints will include quality of life, treatment satisfaction, fear of hypoglycemia, incidence of hypoglycemia.

The group intervention consists of interactive sessions for groups of 5-7 patients, dealing with different aspects of management of type 1 diabetes: insulin therapy and hypoglycemia, management of insulin doses, diet, physical exercise, sick days, etc. The intervention is designed for the acquisition of specific skills of self-management. This intervention is provided by a team including physicians, dietitians, and nurses.

The control group will receive individual education during routine clinic visits, following usual care, complying with the recommendations of national (Italian) guidelines.

HbA1c will be assessed every three months for all the duration of the study. The principal endpoint will be variation from baseline of HbA1c at 12 weeks from the beginning of the intervention.

Eligibility Criteria:
Inclusion Criteria:

* type 1 diabetes

Exclusion Criteria:

* serious diabetic complications, such as to interfere with physical functioning (e.g., lower limb amputation, renal failure requiring dialysis, blindness)
* Illiteracy
Ocular-vestibular Biomarker Identification for ADHD

This study intends to establish a relationship between oculovestibular eye tracking measures, measures of ADHD, and medication prescribed for ADHD.

This study will use a predictive visual tracking paradigm (SyncThink EYE-SYNC eye tracking paradigm) to dynamically capture the participants' attentional state. It will examine the validity of the eye tracking paradigm in identifying the disruption in attentional networks caused by ADHD by examining the association between eye tracking performances and well-established standardized measures of ADHD.

Eligibility Criteria:
Inclusion Criteria:

* Men and women ages 6-70 seeking evaluation and treatment for ADHD.

Exclusion Criteria:

* Clinical diagnosis of a neurological condition including the following: stroke, multiple sclerosis, epilepsy, brain tumor/cancer, dyslexia, nystagmus and/or other major neurological condition.

  * Clinical diagnosis of any of the following eye-sight abnormalities: uncorrected amblyopia, uncorrected myopia, uncorrected presbyopia, uncorrected farsightedness or uncorrected Astigmatism.
  * Psychiatric history with any of the following:
* LIFETIME: Clinical diagnosis of a psychotic disorder; bipolar disorder
* LAST YEAR: Clinical diagnosis of major depressive disorder; PTSD; clinical diagnosis of substance abuse disorder; major anxiety disorder

  * Use of a psychotropic medication
  * Impairment of cranial nerves II-VI
  * Participants who receive a 'Poor' or 'Fair' eye tracking quality result on either their baseline or follow-up evaluations will be excluded from analysis. Subjects may not repeat participation
Effect of Maxillary Nerve Block for Septoplasty

The aim of this study was to determine the effect of maxillary nerve blockage on both postoperative pain scores and recovery quality index in septoplasty operations. Thus, it was aimed to determine an alternative method that can be used in postoperative analgesia that will suppress postoperative pain complaints and increase the comfort level of patients after septoplasty operations.

Patients who were planned to be operated for septoplasty at Adıyaman University Training and Research Hospital, who were informed about the study and agreed to participate in the study with their written consent were included in the study.

The patients who agreed to participate in the study were divided into two groups by closed envelope method and bilateral maxillary nerve blockade was planned to be performed using 10 cc 0.25% bupivacaine via suprazigomatic approach after providing airway safety in the block group with general anaesthesia applications in both groups. The haemodynamic values (blood pressure arterial, peak heart rate, peripheral oxygen saturation), postoperative numeric pain scores and postoperative quality of recovery index (QoR-15) values at the 24th hour were recorded and these values were compared in both groups.

Thus, it was aimed to evaluate the effects of maxillary nerve blockade in septoplasty operations.

Eligibility Criteria:
Inclusion Criteria:

* ASA I-II , Septoplasty patints

Exclusion Criteria:

* ASA III-IV
* Deny to participte in study
Simvastatin For Intracerebral Hemorrhage Study

Study Objective: To analyze if statins are effective in ameliorating perihematomal edema evolution thereby reducing mortality and improving functional outcomes following spontaneous intracerebral hemorrhage (ICH).

Intracerebral hemorrhage (ICH) causes 10% to 15% of first-ever strokes, with a 30-day mortality rate of 35% to 52% with only 20% expected to be functionally independent at 6 months. No medical or surgical interventions have been found to alter the natural evolution of this disease. The high risk for mortality and poor outcomes seems to occur despite relatively small hematoma volumes and small amounts of neuronal tissue at risk for injury. The reasons for this observation remain unknown; however perihematomal edema formation and inflammation that follows ICH seems to play an important role.

The Simvastatin for Intracerebral Hemorrhage Study is a prospective double blinded placebo controlled randomized (1:1) clinical trial that compares outcomes in patients receiving generic simvastatin 80 mg for 14 days or until death or discharge with patients in the placebo group.

The hypothesis for our study is that statins ameliorate perihematomal edema evolution thereby reducing mortality and improving functional outcomes following Intracerebral Hemorrhage (ICH). This hypothesis in turn is based on animal data showing suppression of inflammatory reaction and improved neurological outcomes following administration of statins to rodents with experimental ICH, and on a retrospective review of patients admitted to The Johns Hopkins Hospital over the last 7 years with spontaneous ICH which showed significantly better outcomes (decreased 30 day mortality secondary to decreased perihematomal edema) in patients on statins at the time of admission.

Eligibility Criteria:
Inclusion Criteria:

* Patient with CT evidence of ICH admitted within 24 hours of onset of symptoms.

Exclusion Criteria:

* Age \< 18 or \> 85
* Admission Glasgow Coma Score (GCS) \< 6
* ICH volume \< 10 cc
* ICH secondary to trauma, aneurysm, Arterio-Venous Malformation (AVM), tumor or post surgical
* Multiple ICH
* Associated Subdural hematoma or significant Subarachnoid hemorrhage
* History of prior neurologic disease with modified Rankin Scale (mRS) \> 1
* Hematoma evacuation, hemicraniectomy, clot lysis
* Myopathy
* Active Liver disease
* Pregnancy
* Statin allergy
* Patients on statins prior to admission
* Patients with an acute indication for statin therapy (Unstable angina)
HoLEP vs BPRP of a Large Volume BPH: a Randomised Controlled Trial

To compare bipolar resection versus holmium laser enucleation for management of large BPH.

To compare safety and efficacy of bipolar resection (BPRP) versus holmium laser enucleation (HoLEP) for management of large BPH (\> 75 gm).

Eligibility Criteria:
Inclusion Criteria:

* Patients suffering from LUTS secondary to infravesical obstruction from BPH
* failed medical treatment
* International Prostate Symptom Score (IPSS) \> 13
* a peak urinary flow rate (Qmax) \< 15 ml/sec
* a prostate size ≥ 75 gm

Exclusion Criteria:

* presence of a urethral stricture
* neurological disorder
* bladder cancer
* prostate cancer
* previous history of bladder neck surgery or TURP
A Dedicated Sedation Team for Paediatric Procedural Sedation

At a tertiary care university hospital a specialized interdisciplinary team of paediatric anaesthesiologists and paediatric intensivists was established for providing analgosedation for diagnostic and therapeutic procedures. The aim of the present study was to analyse the incidence and risk factors of adverse events during procedural sedation performed by the Children's Analgosedation Team (CAST).

At a tertiary care university hospital a dedicated Children's Analgosedation Team (CAST) performs all procedural sedations in children outside the operating room. Often patient age, comorbidities and procedures involving the airway are considered risk factors for adverse events, but previous studies investigating adverse events did not involve implementation of a specialised sedation team. Medical records of all children receiving procedural sedation by the CAST were reviewed for the incidence of adverse events. A bivariate analysis as well as an analysis of variance using type II Wald chi-square tests were conducted for identifying potential risk factors for adverse Events.

Eligibility Criteria:
Inclusion Criteria:

* Children (age 0-20 years) receiving procedural sedation
* Procedural sedation performed by the Children's Analgosedation Team

Exclusion Criteria:

* Missing medical records
* Procedural sedation not performed by the Children's Analgosedation Team