cyrilzakka/clinical-trials huggingface dataset:
Seizure Detection and Warning System for Epilepsy Patients

The seizure detection and warning system is an ambulatory system designed to monitor and analyze EMG data to detect the onset of GTC seizures and to provide a warning signal to alert caregivers that a seizure is occurring.


Eligibility Criteria:
Inclusion Criteria:

1. Subject has a suspected history of GTC seizures, either primary GTC or partial onset seizures with secondary generalization.
2. Is being admitted to a hospital for routine vEEG monitoring related to seizures.
3. Male or female between the ages of 13-21.
4. If female and of childbearing potential, has a negative pregnancy urine test, and must also not be nursing.
5. Can understand and sign written informed consent, or will have a parent or a legally authorized representative (LAR) who can do so, prior to the performance of any study assessments.
6. Subject and/or Primary Caregiver must be competent to follow all study procedures.
7. Is able to read, speak, and understand English or has a LAR that does so.
8. Subject/LAR consents to the use of vEEG files, including video/audio recordings, for purposes of this research study.

Exclusion Criteria:

1. Has not had a GTC seizure within the last year AND is not expected to have a reduction of anti-epileptic drugs during their hospital admission.
2. Intracranial EEG electrodes are being used.
3. The subject is allergic to adhesives or any component of the electrode patch assembly
Use Of Blood Flow Rate Profiling For Postdialysis Washed-Out Patients

Hemodialysis patients frequently complain of postdialysis fatigue and washed-out feeling. The aim of this study is to use blood flow rate (BFR) profiling to mitigate postdialysis washed-out state.

Hemodialysis patients who complain of the postdialysis washed-out state were recruited. blood flow rate was altered to be 350 ml/min in the first hour of the session then decreased by 50 ml/min hourly for the 4-hour dialysis session. blood flow rate profiling was continued for 9 dialysis sessions (21 Days). Patients were asked to grade their washed-out state on a scale from 1 (no washed-out state) to 5 (severe washed-out state) before and after blood flow rate profiling. Paired t=-test and Wilcoxon Signed Ranks Test were used in appropriate context to compare washed out scale before and after together with urea reduction rate and other blood chemistry tests.

Eligibility Criteria:
Inclusion Criteria:

* Hemodialysis Patient
* Postdialysis washed-out complain

Exclusion Criteria:

* schedule-non complaint patients
* Patients with recent blood pressure drug modification
Comparative Efficacy of a Toothpaste That Reduces Plaque and Gingivitis

The objective of this study is to evaluate the performance of two toothpastes in controlling established gingivitis and dental plaque in adults.


Eligibility Criteria:
Inclusion Criteria:

* Availability for the six-month duration of the study.
* Good general health.
* Minimum of 20 uncrowned permanent natural teeth (excluding third molars).
* Initial gingivitis index of at least 1.0 as determined by the use of the Loe and Silness Gingival Index.
* Initial plaque index of at least 1.5 as determined by the use of the Quigley and Hein Plaque Index (Turesky Modification).
* Signed Informed Consent Form.

Exclusion Criteria:

* Presence of orthodontic bands.
* Presence of partial removable dentures.
* Tumor(s) of the soft or hard tissues of the oral cavity.
* Advanced periodontal disease (purulent exudate,tooth mobility, and/or extensive loss of
* periodontal attachment or alveolar bone).
* Five or more carious lesions requiring immediate restorative treatment.
* Use of antibiotics any time during the one month prior to entry into the study.
* Participation in any other clinical study or test panel within the one month prior to entry
* into the study.
* Pregnant women or women who are breast feeding.
* Receive a dental prophylaxis in the past two weeks prior to baseline examinations.
* History of allergic to personal care/consumer products or their ingredients.
* Taking any prescription medicines. That might interfere with the study outcome.
* Individuals with an existing medical condition which prohibits them from not eating or drinking for periods up to 4 hours.
A Study on the Safety and Tolerability of Rovalpituzumab Tesirine in Japanese Patients With Advanced, Recurrent Small Cell Lung Cancer

This is a Japanese, multicenter, open-label, dose-escalation study. This is the first study to assess the safety and tolerability as well as explore the pharmacokinetics, pharmacodynamics and antitumor activity of rovalpituzumab tesirine in Japanese participants with advanced small cell lung cancer (SCLC).


Eligibility Criteria:
Inclusion Criteria:

* Histologically or cytologically confirmed advanced, recurrent small-cell lung cancer (SCLC) with documented disease progression after at least two (2) prior systemic regimens, including at least one (1) platinum-based regimen.
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
* Adequate hematologic, hepatic and renal function.

Exclusion Criteria:

* No prior exposure to a pyrrolobenzodiazepine (PBD)-based drug.
Steroid Treatment for Meatal Stenosis

The goal of this observational study is to learn about the efficacy of topical steroid treatment for meatal stenosis.

The main question it aims to answer is:

Is steroid therapy effective for treatment of meatal stenosis? Participants already treated for meatal stenosis will be included.


Eligibility Criteria:
Inclusion Criteria:

* Presence of meatal stenosis

Exclusion Criteria:

* Presence of any anatomical problem or history of surgery
Construction of Computerized Intraoperative Keratometer and Experimental Study

To construct a computerized intraoperative keratometer to analyze the axis of corneal astigmatism accurately as well as rapidly by self-designed software during surgery.

The study is designed to construct a computerized intraoperative keratometer to analyze the axis of corneal astigmatism accurately as well as rapidly by self-designed software during surgery.

Eligibility Criteria:
Inclusion Criteria:

* Cornea astigmatism from -1.0 D to -4.0D;

Exclusion Criteria:

* any significant corneal disease
* Other eye diseases induces impaired vision ,such as retinal detachment,keratoconus,pterygium,glaucoma,choroidal detachment,vitreous hemorrhage,congenital cataract,lens dislocation,anterior uveitis ,pupil deformation and so on;
* Previous corneal or intraocular surgery;
* Refuse surgery;
Diagnostic Performance of PSMA PET/CT for Pre-operative Lymph Node Assessment in Intermediate and High-risk Non-metastasic Prostate Cancer (PREOP-PSMA ).

In France, prostate cancer is the most common cancer in men over 50 years of age (nearly 50,000 new cases per year) and is the second most common cause of cancer death in men (approximately 9,000 deaths per year). Although mortality has been declining since the end of the 1990s (about 7%/year), about 30 to 35% of them will have a biological recurrence.

Accurate assessment of local, regional and distant spread of the disease is therefore needed to design optimal personalised care for each patient, either curative or palliative.

Currently, in France, recommended disease assessment includes bone scintigraphy and Abdomino-Pelvic Magnetic Resonance Imaging. However, conventional imaging has limited performance with regard to lymph node extension.

Node dissection is the best way to assess node status. Currently, no imaging exam allows this level of accuracy.

Recently, molecular imaging has emerged as a promising tool to improve the initial extensional assessment of prostate cancer. Prostate-specific membrane antigen (PSMA) is a transmembrane glycoprotein, specific to the prostate, which is over-expressed on the surface of prostate cancer cells.

Recent studies of PSMA PET/CT as part of the initial extension assessment of prostate cancer report superior diagnostic performance in terms of sensitivity and specificity compared to conventional tests, as well as an impact of PSMA PET/CT on patient management.


Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed prostate cancer;
* Intermediate-risk prostate cancer (PSA level of 10- 20 ng/mL and/or Clinical tumor stage ≥ T2b and/or ISUP 2 or 3, AND with risk of lymph node extension \> 5% according to the Briganti nomogram) or high-risk prostate cancer (PSA ≥ 20 ng/mL and/or TR ≥ T2c and/or ISUP 4 or 5) according to d'Amico classification;
* Curative treatment by radical prostatectomy chosen by the multidisciplinary consultation meeting.

Exclusion Criteria:

* Refusal or inability to participate in the study ;
* Low-risk prostate cancer according to D'Amico's classification, or an intermediate-risk but with a risk of lymph node extension \<5% according to Briganti's nomogram;
* Curative treatment other than surgical treatment chosen;
* Life expectancy \< 12 months;
* Karnofsky score \< 70 or ECOG score \> 2.
Clinical Trials Education Program for Hispanic Americans

Hispanic Americans are underrepresented in cancer clinical trials. The purpose of this study is to develop and test programs designed to reduce barriers and increase facilitators associated with cancer clinical trials participation for Hispanic Americans.

Hispanic Americans are underrepresented in cancer clinical trials. The purpose of this study is to develop and test education programs designed to reduce barriers and Increase facilitators associated with cancer clinical trials participation for Hispanic Americans. Focus groups were conducted with Hispanic American men and women to obtain culturally-linked attitudes related to clinical trials participation. This information was used to create a prototypic educational program anticipated to increase participation in clinical trials. It was then vetted and honed via additional focus groups.

Simultaneously, a validation study was conducted with Hispanic Americans for a packet of psychosocial instruments that could be used for a subsequent randomized controlled trial to evaluate the impact of the clinical trials education program.

The finalized clinical trials education program was tested via a randomized controlled trial. Participants assigned to the experimental group received the clinical trials education program, while participants in the control arm were administered a comparable, but non-relevant education program. Recruitment to this study has been completed.

Eligibility Criteria:
Inclusion Criteria:

* Self-identified as Hispanic American
* At least 21 years of age
* Sufficiently literate to comprehend written and spoken testing materials in English or Spanish
* Living in southern California
* Mentally competent to complete the informed consenting process

Exclusion Criteria:

-
Smart-phone Application to Promote Medication Adherence in Adolescents and Young Adults (AYA) With Cancer

To explore use of a smart-phone medication reminder application to promote adherence to oral medications by AYA with cancer.

Non-adherence to oral medications is a prevalent problem in adolescents and young adults (AYA) with cancer that may impact both survival and quality of life while on treatment. The purpose of this study is to explore use of a smart-phone medication reminder application to promote adherence to oral medications by AYA with cancer. The study's primary aim is to explore the feasibility and acceptability of using a smart-phone medication reminder application to promote adherence to oral medications by AYA with cancer as well as to characterize application use. Secondary aims include: 1) to obtain initial estimates of intervention effect- measured by pre-intervention to post-intervention differences in perceived behavioral control for adherence, intention to adhere, and adherence behavior - to inform design of a future trial powered to detect a clinically significant effect of smart-phone medication reminder application use on adherence to oral medications; and 2) to examine the relationships among perceived behavioral control for adherence, intention to adhere, and adherence behavior. A pre-post single group design will be used. Data will be collected weekly for 4 weeks before introduction of the intervention and for 8 weeks following introduction of the intervention. Analytic approaches will include descriptive statistics and generalized estimating equation (GEE) modeling.

Eligibility Criteria:
Inclusion criteria:

1)15-29 year olds receiving treatment for any type of cancer, either primary or recurrent/relapsed disease.

2) Patient has completed at least one month of therapy

3)Patient is expected to remain on therapy for 3 month duration of study

4) Patient has an iPhone, iPad, or iTouch running iOS 4.0 or later

5) Patient is willing to use a smart-phone medication reminder application-

Exclusion Criteria:

1)Patients who are unable to speak/read/write English as required for use of smart-phone medication reminder application and completion of study measures.
Optimal Duration of Pre-operative Treatment With Letrozole and to Correlate Clinical Efficacy With Appropriate Surrogate Markers

This study will assess optimal duration of pre-operative treatment with letrozole and to correlate clinical efficacy with appropriate surrogate markers.


Eligibility Criteria:
Inclusion criteria:

1. Female Breast Cancer patients with primary invasive breast cancer, histologically confirmed by core needle biopsy, whose tumors are estrogen (ER) and / or progesterone (PgR) positive (Clinical Stage \*T2, T3, T4a,b,c, N0, M0)
2. Patients after menopause
3. Tumor measurable by clinical examination, mammography and ultrasound
4. Adequate bone marrow, renal and hepatic function
5. A life expectancy of at least 6 months.

Exclusion criteria:

1. Prior treatment with aromatase inhibitors or antiestrogens.
2. Uncontrolled endocrine disorders such as diabetes mellitus, confirmed hypo- or hyperthyroidism, Cushing´s Syndrome, Addison´s disease (treated or untreated), Patients with unstable angina, uncontrolled cardiac disease (e.g. Class II or IV New York Heart Association's Functional Classification).
3. Patients with tumors in both breasts, evidence of inflammatory breast cancer or distant metastasis
4. Patients who are eligible for breast conserving surgery.
5. Concomitant anti-cancer treatments such as chemotherapy, immunotherapy/biological response modifiers (BRM's), endocrine therapy (including steroids), bisphosphonate therapy and radiotherapy. Patients who have received HRT will NOT be excluded, provided that HRT is discontinued at least 2 weeks prior to entry into the study.

Other protocol defined inclusion/exclusion criteria may apply
The Value of Tranxemic Acid to Reduce Intraoperative Blood Loss During Elective Cesarean Sections in High Risk Women

A full medical history will be obtained from all participants. Obstetric ultrasonography and laboratory tests will be performed.According to group assignment, either 1 g(10 mL) tranexamic acid stored in a dry container at 15 °C-30 °C) diluted in 20 mL of 5% glucose or 30 mL of 5% glucose will be slowly administered intravenously 15 minutes before skin incision over a 5-minute period.

Following delivery, patients in both groups will receive an intravenous bolus of 5 IU oxytocin , 1 mL(0.2 mg) intramuscular ergometrine , and 20 IU oxytocin in 500 mL lactated Ringer's solution(infused at a rate of 125 mL/h)

A full medical history will be obtained from all participants. Obstetric ultrasonography and laboratory tests will be performed, including prothrombin time, prothrombin concentration, complete blood count, and liver and kidney function tests. Maternal body weight and vital signs (heart rate, blood pressure, and respiratory rate) will be checked 30 minutes before surgery. According to group assignment, either 1 g(10 mL) tranexamic acid (Kapron, Amoun, Egypt; stored in a dry container at 15 °C-30 °C) diluted in 20 mL of 5% glucose or 30 mL of 5% glucose will be slowly administered intravenously 15 minutes before skin incision over a 5-minute period.

Following delivery, patients in both groups will receive an intravenous bolus of 5 IU oxytocin (Syntocinon, Novartis, Basel, Switzerland), 1 mL(0.2 mg) intramuscular ergometrine (Methergin, Novartis, Basel, Switzerland), and 20 IU oxytocin in 500 mL lactated Ringer's solution(infused at a rate of 125 mL/h).

Fluid monitoring will be performed through rate of infusion and urine output. A complete blood count test will be performed 24 hours after delivery. On discharge, patients who received tranexamic acid will be given a brief orientation regarding symptoms and signs of a thromboembolic event and will be instructed to contact the investigators immediately if any occurred.

All patients will be examined for thromboembolic events at the 1- and 4-week follow-up visits

EBL will be calculated according to the formula:

EBL = EBV x Preoperative hematocrit-Postoperative hematocrit Preoperative hematocrit where EBV is estimated blood volume (mL; weight in kg × 85). For a two-tailed test at an α level of 0.05, the difference between the two groups regarding the primary outcome measure (EBL) had a power of 1.0 (100%) in a post hoc calculation.

Eligibility Criteria:
Inclusion Criteria:

* • Grand multipara

  * Multiple pregnancy
  * Polyhydraminos (AFI is more than 24 cm).
  * Placenta previa
  * Gestational diabetes mellitus
  * Preeclampsia
  * Anemia complicating pregnancy (Hemoglobin is less than 11 gm/dl)

Exclusion Criteria:

* • Allergy to tranxemic acid.

  * H/o suggestive of bleeding disorders
  * previous history of deep vein thrombosis
  * Abnormally invasive placenta
  * Emergency cesarean sections
  * Intraoprative complications during cesarean sections as uterine artery injury and broad ligamentary hematoma.
Angiotensin II in Liver Transplantation

The purpose of this study is to determine the efficacy and safety of Angiotensin II as a second-line vasopressor (drug that raises the blood pressure) during liver transplantation.

This is a single center, randomized, double-blind, placebo-controlled trial. Subjects will receive an infusion of either Angiotensin II (AngII) or a saline control (placebo) in addition to usual care with traditional vasopressors (catecholamines and vasopressin) during liver transplantation (LT). AngII is a vasopressor approved by the FDA for the treatment of vasodilatory shock. It targets the renin-angiotensin system (RAS) and has been shown to effectively raise the mean arterial blood pressure (MAP) in patients with septic shock. It also allows for lower doses of traditional vasopressors and may improve microcirculatory flow to the kidneys. The study drug will only be administered if the participants require \> 0.05 mcg/kg/min of norepinephrine while undergoing liver transplantation. The study drug will be titrated throughout the case and discontinued at the end of surgery. Randomization will be stratified based on (a) the need for renal replacement therapy preoperatively and (b) the use of normothermic machine perfusion of the liver graft.

Eligibility Criteria:
Inclusion Criteria:

* Age \> or = 18 years
* Liver transplantation from a deceased donor
* Model for End-stage Liver Disease Sodium (MELD-Na) score \> or = 25 at the time of transplant (not counting MELD exception points)
* Patient requiring \> 0.05 mcg/kg/min of norepinephrine (NE) during LT

Exclusion Criteria:

* Living-donor liver transplantation (LDLT)
* Split liver transplantation (isolated right or left lobe)
* Donation after cardiac death (DCD) without normothermic machine perfusion (NMP)
* Acute liver failure (ALF)
* Listed for or receiving simultaneous liver-kidney transplantation (SLKT)
* Liver re-transplantation (patient who has previously received a liver transplant)
* Preoperative treatment with angiotensin II receptor blocker or angiotensin converting enzyme inhibitor (within 48 h)
* Portopulmonary hypertension
* Left ventricular systolic dysfunction (defined as ejection fraction \< 45%)
* Active bronchospasm at time of LT
* History of thrombotic or embolic disease, inherited hypercoagulable disorder, or therapeutic anticoagulation
* Portal vein thrombosis
* Celiac stenosis
* End-stage renal disease (chronic eGFR \< 15 mL/min/1.73 m2 or chronic RRT - not including AKI requiring RRT)
* History of Raynaud's disease
* Known history of allergy to synthetic human angiotensin II
* Subject intubated and/or mechanically ventilated prior to entering OR for LT
* Presence of other condition or abnormality that would compromise the safety of the patient or quality of the data
Assessment of Colonic Permeability by Confocal Laser Endomicroscopy

The purpose of this study is to evaluate the efficacy of confocal laser endomicroscopy in assessment of colonic permeability against conventional sugar absorption test.

Increased intestinal permeability has been shown significant in many gastrointestinal diseases, including inflammatory bowel disease and recently irritable bowel syndrome. The conventional test methods of permeability is sugar absorption test which is neither reliable and practical. Confocal laser endomicrosopy is a newly developed device which allows in vivo and real time observation of gastrointestinal mucosa. In our preliminary study we found that the commonly used contrast agent, fluorescein sodium shew differences of leakage into colonic crypt lumen among different patients. The fluorescein leakage might be due to abnormal colonic permeability, so we planed to compare the fluorescein leakage under confocal laser endomicroscopy with conventional sucralose absorption test.

Eligibility Criteria:
Inclusion Criteria:

* Patients with history of ulcerative colitis
* Bowel habits alterations meeting IBS diagnosis criteria and indications for colonoscopy investigation
* Asymptomatic individuals for health surveillance or patients for follow up after polypectomy
* Patients complained of hemafecia but colonoscopy revealed only haemorrhoid

Exclusion Criteria:

* Known cancers or abdominal surgery
* Scheduled for endoscopic treatment
* Alarm symptoms such as anaemia, gastrointestinal bleeding or obstruction, marked weight loss, abdominal mass
* Under conditions such as:

  * ascites
  * jaundice
  * liver cirrhosis
  * impaired renal function
  * coagulopathy
  * fever
  * pregnancy
  * breastfeeding
* Inability to provide informed consent
* Known allergy to fluorescein sodium
Sorafenib in Hepatocellular Carcinoma Clinical Practice in Italy

Prospective, non-interventional, multi-center study. Patients affected by Hepatocellular Carcinoma (HCC) who are candidates for systemic therapy and in whom a decision to treat with sorafenib has been made. Aim of this non-interventional, post-marketing study is to evaluate the efficacy of sorafenib in terms of overall survival rate at 12 months in patients with HCC under daily-life treatment conditions.


Eligibility Criteria:
Inclusion Criteria:

* Patients with histologically/cytologically confirmed HCC or radiographically diagnosed as per AASLD criteria, who are candidates for systemic therapy and for whom a decision to treat with sorafenib has been made
* Patients must have signed the informed consent form
* Patients must have a life expectancy of at least 8 weeks Inclusion criteria must follow the approved local product information.

Exclusion Criteria:

* Prior treatment with sorafenib
* Concomitant participation in other clinical studies Exclusion criteria must follow the approved local product information.