cyrilzakka/clinical-trials huggingface dataset:
Nomograms to Precisely Predict Conditional Risk of Recurrence for Patients With Laryngeal Cancer

Advanced laryngeal squamous cell carcinoma (SCC) remains a highly morbid and fatal disease despite aggressive interventions. Mortality is high in this cohort: laryngeal cancer affects over 13 000 patients in the United States, with over 3500 deaths annually.The results of the Veterans Affairs Cooperative Studies Program Laryngeal Cancer Trial and subsequent studies demonstrated similar overall survival (OS) rates for organ preservation protocols involving radiotherapy (RT) or chemoradiotherapy (CRT) when compared to surgery, with the benefit of preserving the larynx in a large majority of patients. As such, the use of RT or CRT has become the predominant initial intervention for patients with laryngeal SCC.6 However, the prognosis of recurrent and persistent laryngeal SCC is particularly dire.In this study, we sought to identify preoperative predictors of survival for patients with recurrent or persistent laryngeal SCC in order to set patient expectations and address modifiable risk factors. Identification of predictors of survival may also identify patients who could benefit from novel therapeutic agents in a neo/adjuvant fashion. Herein,we examine a cohort of patients with recurrent or persistent laryngeal SCC after definitive RT/CRT who has undergone total laryngectomy in order to identify potential preoperative predictors of clinical outcomes.

Demographic, clinical, and survival data were abstracted. Death was verified via medical records and the social security death index. Primary outcome measures were OS (time from salvage laryngectomy to death from any cause), disease-specific survival (DSS; time from salvage laryngectomy to death from recurrent/persistent laryngeal SCC), and DFS (time from salvage laryngectomy to laryngeal SCC recurrence)

Eligibility Criteria:
Inclusion Criteria:

patients with a diagnosis of laryngeal squamous cell carcinoma

Exclusion Criteria:

multiple primarry malignant neo-plasms
A Study of Niraparib in Combination With Abiraterone Acetate and Prednisone Versus Abiraterone Acetate and Prednisone for Treatment of Participants With Metastatic Prostate Cancer

The purpose of this study is to evaluate the effectiveness of niraparib in combination with abiraterone acetate plus prednisone (AAP) compared to AAP and placebo.


Eligibility Criteria:
Inclusion Criteria:

* HRR gene alteration (as identified by the sponsor's required assays) as follows:

  1. Cohort 1: positive for HRR gene alteration
  2. Cohort 2: not positive for DRD (that is, HRR gene alteration)
  3. Cohort 3: eligible by HRR status
* Metastatic disease documented by positive bone scan or metastatic lesions on computed tomography (CT) or magnetic resonance imaging (MRI)
* Metastatic prostate cancer in the setting of castrate levels of testosterone less than or equal to (\<=) 50 nanogram per deciliter (ng/dL) on a gonadotropin releasing hormone analog (GnRHa) or bilateral orchiectomy
* Able to continue GnRHa during the study if not surgically castrate
* Score of \<= 3 on the brief pain inventory-short form (BPI-SF) question number 3 (worst pain in last 24 hours)

Exclusion Criteria:

* Prior treatment with a poly (adenosine diphosphate \[ADP\]-ribose) polymerase (PARP) inhibitor
* Systemic therapy (that is, novel second-generation AR-targeted therapy such as enzalutamide, apalutamide, or darolutamide; taxane-based chemotherapy, or more than 4 months of abiraterone acetate plus prednisone \[AAP\] prior to randomization) in the metastatic castration-resistant prostate cancer (mCRPC) setting; or AAP outside of the mCRPC setting
* Symptomatic brain metastases
* History or current diagnosis of myelodysplastic syndrome (MDS)/acute myeloid leukemia (AML)
* Other prior malignancy (exceptions: adequately treated basal cell or squamous cell skin cancer, superficial bladder cancer, or any other cancer in situ currently in complete remission) \<= 2 years prior to randomization, or malignancy that currently requires active systemic therapy
Improving Antimicrobial Prescribing Practices in the Neonatal ICU

To determine if 3 randomly assigned bundles of stewardship interventions would reduce overall and inappropriate antimicrobial use in the neonatal intensive care unit (NICU), a pre-post study was performed in 4 NICUs.

Antimicrobial stewardship can improve the safety and quality of healthcare, reduce antimicrobial resistance, and reduce healthcare costs. However, the optimal strategies for the NICU population are unknown and few studies have evaluated the impact of stewardship in this population. To determine if 3 randomly assigned bundles of stewardship interventions would reduce overall and inappropriate antimicrobial use in the NICU. The investigators hypothesized that the bundle using all three interdisciplinary antimicrobial stewardship strategies (education, computer decision support and prescriber audit and feedback) would more effectively reduce overall and inappropriate antimicrobial use compared to usual care. A pre-post intervention study (one baseline year without interventions - May 1, 2009 - April 30, 2010, followed by two years of interventions - May 1, 2010 - April 30, 2012) was performed in 4 academically affiliated, level III NICUs. The sites were randomly assigned to usual care, one intervention, two interventions, or three interventions.

Eligibility Criteria:
Inclusion Criteria:

* infants admitted to study NICUs \<7 days of age who remained hospitalized 4 days or more days

Exclusion Criteria:

* Infants admitted to study NICUs 7 days of age and older who were hospitalized less than 4 days
Study on the Effectiveness of Gastroscope Operation Quality Control Based on Artificial Intelligence Technology

This study aims to construct a real-time quality monitoring system based on artificial intelligence technology.

Gastroscopy plays an important role in the detection and diagnosis of upper gastrointestinal diseases. It is necessary for endoscopists to operate gastroscope according to the standardized process, in order to avoid missing early lesions. However, with the rapid increase in the number of endoscopies, the workload of endoscopists increases further. High workload reduces the quality of endoscopy, resulting in incomplete observation of anatomical parts that are easy to be missed in the process of gastroscopy. There are significant differences in the operation level of different endoscopists. Therefore, carrying out artificial intelligence methods has good academic research and practical value for improving the quality of endoscopic diagnosis and treatment.

Artificial intelligence devices need to use a large number of endoscopic images, based on this, we intends to collect endoscopic image data from our hospitals for training and validation of the model.

Eligibility Criteria:
Inclusion Criteria:

1. Patiens aged 18 years or above undergoing gastroscopy；
2. Be able to read, understand and sign informed consent；

Exclusion Criteria:

1. Patients with absolute contraindications to endoscopy examination;
2. pregnant women;
3. previous history of gastric surgery;
4. the researcher considers that the subject is not suitable for clinical trial.
Safety and Long-term Evaluation (up to 5 Years) of First Booster Immunization With Novartis' TBE Vaccine for Adults in Adolescents and Adults

evaluate safety and immunogenicity of first TBE booster and long-term immunogenicity up to 5 years after first TBE booster


Eligibility Criteria:
Inclusion Criteria:

* healthy subjects who have completed study V48P7

Exclusion Criteria:

* acute illness at day of immunization
* general decrease in resistance
* progressive neurological disorders
* history of febrile or afebrile convulsions
* major congenital defects
* serious chronic illness
* hypersensitivity to study vaccine
* treatment with immunosuppressants or systemic corticosteroids, immunoglobulins, whole blood or plasma derivates
Intrathecal Hydromorphone for Postoperative Pain of Anorectal Surgery

Anorectal problems, such as hemorrhoids, fistula, fissures, Etc., often require surgical treatment. Patients often have postoperative pain after these surgeries, which increases discomfort and hospital length of stay. The efficacy of oral non-opioids in the treatment of such pain is poor. Hydromorphone is an opioid analgesic commonly used orally or intravenously for postoperative pain management. We designed this trial to investigate the efficacy and safety of intrathecal (delivery directly to the spinal cord during spinal anesthesia) single dose hydromorphone versus intrathecal placebo in treating postoperative pain among human subjects after anorectal surgery, but also the recovery of postoperative motor capacity in these human subjects.


Eligibility Criteria:
Inclusion Criteria:

* 1. Clinical Diagnosis of anorectal disease, ready to undergo elective surgery
* 2. American Society of Anesthesiologists(ASA) physical status I-II
* 3. Desire to have a spinal anesthesia
* 4. Must be able to follow the medication dose and visit schedule

Exclusion Criteria:

* 1. Any contraindications to spinal anesthesia and intrathecal analgesia.
* 2. Complex co-morbidities, including

  1. Severe infection,
  2. Respiratory insufficiency,
  3. History of psychiatric or neurological disorders and other cognitive impairments
* 3. Chronic pain syndrome or current opioid use \>10mg oral morphine equivalents/day
* 4. Allergy or intolerance to hydromorphone, NSAIDs and Cox-2 selective Inhibitor
* 5. Clinical diagnosis of obstructive sleep apnea syndrome(OSAS)
* 6. History of drug abuse
* 7. Women who are breastfeeding or pregnant
* 8. Participation in other clinical trials within three months
* 9. Already participated in this study once
* 10. Not considered suitable for the clinical trial by the investigators
Aquagenic Wrinkling Prediction

The goal of this observational study is to determine whether an aquagenic wrinkling procedure (i.e., soaking hands in a water bath for up to 20 minutes) can be used as a screening tool for cystic fibrosis carrier status.

Participants will complete one visit where they will undergo an aquagenic wrinkling procedure to see how their hands respond.


Eligibility Criteria:
Inclusion Criteria:

* Interested in participating in other CF Carrier-related research studies.

Exclusion Criteria:

* CF patient status
* Unable to speak English
* Unable to provide written informed consent
* Prisoner status
* An open wound on either hand
* A tattoo on either hand
* Missing any portion of either hand
* Diagnosis of Diabetes
* Diagnosis of Hyperhidrosis
* Diagnosis of Raynaud's Disease
* Diagnosis of Atopic Dermatitis
* Regularly taking ACE inhibitors or angiotensin receptor blockers
A Phase 1 Comparative Study of E2022 Current and New Patch Formulations

The purpose of this study is to investigate the safety and pharmacokinetics of new patch formulation (tape) of E2022 by conducting patch test.


Eligibility Criteria:
Inclusion criteria

1. Non-smoker or not smoking for 4 weeks or longer before study treatment
2. BMI at screening is greater than or equal to 18.5 kg/m2 or less than 25.0 kg/m2
3. With written informed consent
4. Given full explanation of this study and is willing to and able to comply with study requirements.

Exclusion criteria

(Cohort 1 and 2):

1. Have a disorder which affects the evaluation of study drug such as psychiatric, gastrointestinal, hepatic, renal, respiratory, endocrinological, hematological, neurological, or cardiovascular system, or congenital metabolic abnormality
2. Have a clinically significant abnormality or organ dysfunction
3. Have a history of allergy to drug or food requiring medical treatment or seasonal allergy at screening
4. Have a history or complication of contact dermatitis or atopic dermatitis
5. Have hairy back or have shaved within 4 weeks before study treatment
6. Have a skin disease (e.g., eczema, dermatitis, dyschromatosis), or skin damage (e.g., injury, scar, or sun burn) which may affect skin assessment
7. Have a history or suspected to have drug or alcohol dependence, or positive for urine drug screen at baseline or a day before screening
8. Have had caffeine-containing drink or food, or alcohol within 72 hours before study treatment
9. Have used liquid product (including cosmetics), or applied patch, tape, or bandage on the back within 4 weeks before study treatment
10. Had hard exercise at least 5 days a week or a 1-hour or longer hard exercise within 2 weeks before study treatment

(Only Cohort 2):

1. Meet QTc of greater than 450 milliseconds at screening or immediately before study treatment
2. Had nutrients, herb preparations (e.g. oriental medicine), other food or drink (e.g., grapefruit-containing juice) which may affect the activity of drug-metabolizing enzyme or transporter within 2 weeks before study treatment
3. Had St. John's Wort-containing preparation within 4 weeks before Period 1 application
Effects of Therapeutic Doses of Acetaminophen in Moderate Drinkers

The study objective was to evaluate the safety of ten consecutive days of therapeutic acetaminophen dosing in moderate alcohol consumers. The main outcome was liver injury (measured by an increase in mean serum ALT or AST levels). Patients were randomly assigned to 10 days of acetaminophen or placebo. Blood tests were measured at baseline, day 4 and day 11 to look for injury. We hypothesized that there would be no difference in liver enzymes between the two groups.


Eligibility Criteria:
Inclusion criteria Adult volunteers of age 21 years or older, regardless of ethnicity or gender, who provided written consent and met all three of the following criteria of a moderate alcohol consumer:

1. Average baseline ethanol consumption of at least one alcoholic beverage per day before enrollment for the past two months. The estimate of ethanol intake was based on the average intake over seven days. For example, a person who ingested no alcohol on Sunday, Monday, Tuesday or Wednesday, two drinks on Thursday and four drinks on Friday and Saturday would be calculated as 10 drinks/7days = 1.4 drinks/day. The average alcoholic beverage contains 15 grams of alcohol(9).
2. Average baseline ethanol consumption of no more than three alcoholic beverages (\> 45 grams of alcohol) per day, calculated as a weekly average over the preceding two months.
3. At least one alcohol-containing drink within the last 48 hours

Exclusion Criteria

Subjects were excluded from the study at baseline if any of the following were evident at baseline:

1. Serum acetaminophen level greater than 20 mcg/ml
2. Serum AST or ALT levels greater than 50 IU/L
3. If female, positive for b-HCG
4. Clinically intoxicated, psychiatrically impaired or unable to give informed consent
5. Known hypersensitivity to acetaminophen
6. History of ingesting more than four grams of acetaminophen per day for any of the four days preceding study enrollment
7. Alcoholic patients as defined by those who consume on average more than three alcoholic beverages daily
8. Currently enrolled in another trial or had been enrolled in another trial in the preceding three months
Lifestyle Changes and Glycemic Control in T1D

Pakistani studies report non-adherence to self-management by type 1 diabetes (T1D) patients, and episodes of hypoglycemia and ketoacidosis as acute complications. Self-management guidelines include maintenance of logbooks for blood glucose, physical activity, and dietary intake, that affect glycated hemoglobin (HbA1C) and acute complications. The proposed study will evaluate whether mobile messaging for maintaining log books for blood glucose or e-device use for step count will modify HbA1c levels to be examined at three and six months after enrollment. In addition, episodes of acute complications and blood glucose variability will be correlated with daily log book maintenance and step counts.

Type 1 diabetes (T1D) occurs due to destruction of insulin producing beta cells in pancreas. T1D usually occurs in children and young individuals, and requires continuous blood glucose monitoring for adjustment of insulin dosage on a daily basis. Incidence of T1D has been increasing over the past three decades. Hyperglycemia and ketoacidosis episodes are common adverse effects due to irregular monitoring of daily blood glucose. It is a big challenge in developed as well as developing countries to live with T1D due to less optimal use of timely entry in logbook for self-monitoring of blood glucose (SMBG). Current guidelines recommend SMBG use in all patients with diabetes. According to a study, increased daily frequency of SMBG was significantly associated with lower glycated hemoglobin (HbA1C) along with added benefits of fewer acute complications among children and adolescents. Available literature from Pakistan highlights non-adherence of T1D patients to recommended dietary advice (58.5%), physical activity (42.3%) and prescribed insulin regimen (88.1%). Use of mobile applications has been shown to increase the medication adherence and use of self-blood glucose testing. Increased daily step count by T1D patients helped to reduce the risk of cardiovascular events. A wearable e-device accompanied with an application (Fitbit App) tracks step count by recording data in mobile application. HbA1C levels acts as an indicator for the glycemic control and correlates with complications. However, HbA1C cannot determine the daily variability of blood glucose, thus SMBG can help predict the average daily risk reduction in T1D complications. The proposed study will address the adherence to standard protocols for maintaining home based records by patients and caregivers and insulin therapy, optimizing the quarterly HbA1C levels.

Eligibility Criteria:
Inclusion Criteria:

* Patient diagnosed with T1D \> 6 months
* Patient's age ≥ 15 years
* Patient or any one of the family member like father, mother or sibling using smart phone.
* Patient or any one of the family member know how to use (receive calls or read text message) a smart phone.

Exclusion Criteria:

* Patient on insulin pump
* Pregnant females,
* Patient with neurodevelopmental delay or thalassemia
* Patient currently using any kind of authentic e-device for step count or physical activity.
Effectiveness of Standard Emergency Department Psychiatric Treatment Associated With Treatment Delivery by a Suicide Prevention Center

Very few studies have proved the effectiveness of treatment for suicide attempt patients. Our objective is to evaluate the addition of the resources of an suicide prevention centre to standard psychiatric treatment in the Emergency Department. Consecutive suicide attempt patients in 2 Emergency departments (multicenter study) were included after standard psychiatric treatment and referral. After Written informed consent, psychological assessment (depression, suicide intention) was carried out After randomisation, control patients were given an information card describing the Suicide Prevention Center (SPC); experimental patients had a first meeting with a psychologist of the SPC.

To verify the hypothesis of a decrease in suicidal behaviors in the experimental group, an evaluation of these behaviors was carried out every month during a two year follow-up.

Very few studies have proved the effectiveness of treatment for suicide attempt patients. Our objective is to evaluate the addition of the resources of an existent suicide prevention centre to standard psychiatric treatment in the Emergency Department. Consecutive suicide attempt (self poisoning) patients in 2 Emergency departments (multicenter study) were included after standard psychiatric treatment and referral. After Written informed consent, psychological assessment (depression, suicide intent scale/SIS Beck Depression Inventory, Toronto Ale, Beck Hopelessness Sc, Audit, mini, PDQ 4) was carried out After randomisation, control patients were given an information card describing the Suicide Prevention Center (SPC); experimental patients had a first meeting with a psychologist of the SPC. The number of subjects included should be 405 per group. To verify the hypothesis of a decrease in suicidal behaviors in the experimental group, an evaluation of these behaviors was carried out every month during a two year follow-up The frequency of subsequent suicidal behavior will be monitored by the scrutiny of the Emergency Dept records. Death by suicide will be identified by the examination of information obtained from the national death statistics office (INSERM).

Eligibility Criteria:
Inclusion Criteria:

* parasuicide by self-poisoning
* Glasgow score=15
* Standard psychiatric treatment

Exclusion Criteria:

* No speaking french
* committed inpatient
Collection of Blood From Patients With Cancer

This study will collect blood from patients with cancer to study the level of cells which decrease the immune response (suppressor cells) before and after chemotherapy. Patients 18 years of age and older with cancer may participate. This study does not involve treatment.

Participants will have about 50 ml (3 tablespoonfuls) of blood drawn. Depending on their condition, patients may be invited to enroll in a clinical research study involving chemotherapy, radiotherapy, or surgery. Additional 40-ml blood samples may be drawn during the course of treatment.

Background:

* Correlative studies performed on biospecimens of human subjects can be used to investigate the biology of solid tumors, inform the development of new strategies for treating those cancers, and evaluate these new therapeutic approaches. Specific areas of interest include, but are not limited to:
* the underlying mechanisms of tumor-specific immune response and suppression in cancer patients
* genetic and molecular profiling of tumors through circulating tumor cell (cTC), circulating DNA, and tissue analysis
* investigation of potential early diagnostic and prognostic indicators for solid tumors such as cTCs and miRNA expression of serum exosomes
* identification of mechanisms of drug-related adverse events and correlation with clinical parameters
* the role of commensal gut microbiota in both the innate and adaptive responses to tumors as well as with the use of anticancer agents

Objectives:

* Analyze biospecimens such as tissue, urine, saliva, stool and blood components, which include serum, leukocytes, peripheral blood mononuclear cells (PBMC), and circulating tumor cells (cTC), of human subjects.
* Correlate analysis results with clinical parameters such as demographics, toxicities, and treatment outcomes.
* Undertake genetic analysis of both prokaryotic and eukaryotic samples for advanced mutational analysis.

Eligibility:

* Patients and healthy volunteers whose biospecimens are of interest to NIH investigators.
* 18 years of age or older.

Design:

- Cases will be evaluated by NCI or Interventional Radiology, NIH Clinical Center personnel. Blood, tissue, urine, saliva or other samples may be collected at the initial visit and at follow-up visits.

Eligibility Criteria:
* INCLUSION CRITERIA:

Patients with a known or suspected malignancy and healthy volunteers 18 years of age and older are eligible.

Performance status of ECOG 0, 1, 2, or 3 for admission to this protocol.

Ability to understand and the willingness to sign a written informed consent document.

INCLUSION FOR APHERESIS:

Note: Effective with Amendment CC, participants will no longer be asked to undergo apheresis. This content is being retained for historical reference.

Hemoglobin greater than or equal to 10 mg/dL and platelet count \> 75,000/mm(3)

Weight greater than 25 kg

HIV negative

Prothrombin Time - within normal limits

Partial Thromboplastin Time - within normal limits

Medically indicated central line in place or adequate peripheral venous access

EXCLUSION CRITERIA:

None.