cyrilzakka/clinical-trials huggingface dataset:
Trial Comparing Sedation for Endoscopy With Propofol Versus Midazolam in Cirrhotics

To compare effects of sedation for upper gastrointestinal endoscopy with propofol and midazolam on psychometric tests and critical flicker frequency (CFF) in cirrhotics

Upper GI Endoscopy is routinely performed in patients with chronic liver disease to screen for complications related to portal hypertension such as esophageal and gastric varices and portal gastropathy. Sedation is frequently administered to facilitate patient tolerance.Patients with hepatic dysfunction who undergo endoscopy are at increased risk for complications related to sedation.Propofol has a favorable pharmacokinetic profile in comparison with benzodiazepines and opioids, which makes it especially appropriate for sedation in endoscopy.In previous studies cognitive functions were assessed by various paper and pencil tests. However learning affects the paper and pencil tests if repeated at short interval of time.CFF analysis was found to be sensitive and objective in the quantification of low-grade HE, and there is a significant correlation between CFF and the portosystemic encephalopathy syndrome (PHES) battery.Considering this, we designed a prospective randomized controlled study with cirrhotic outpatients to compare effects of sedation for upper gastrointestinal endoscopy with propofol versus midazolam on psychometric tests and critical flicker frequency in cirrhotics

Eligibility Criteria:
Inclusion Criteria:

* Known chronic liver disease (Child-Pugh class A , B or C ) who presented for upper GI endoscopy for routine variceal screening.
* The diagnosis of liver disease will be based on available past history, serological testing, radiological imaging, and liver histology when available.
* Staging of cirrhosis will be determined by MELD score and by Child-Pugh score . All patients will complete a standard preprocedure history and physical examination to establish current degree of encephalopathy and ascites.

Exclusion Criteria:

* Active GI bleeding
* Overt encephalopathy
* Active alcohol intake during the past 6 weeks
* Significant co morbid illness such as heart, respiratory, or renal failure and any neurologic diseases such as alzheimer's disease, parkinson's disease and nonhepatic metabolic encephalopathies.
* Patients with known allergy to sedative
* hepatocellular carcinoma
* Previous TIPS or shunt surgery,
* Patients on psychoactive drugs, such as antidepressants or sedatives
* Patients with an American Society of Anesthesiology (ASA) physical status of class IV or V
* Patients with visual or mental impairment who will unable to complete the psychometric testing or CFF
Human Papilloma Virus (HPV) Knowledge and Attitudes and the Role of (SES) Socioeconomic Status and Ethnicity

This is a survey study to assess the vaccination knowledge and attitudes of women in an inner city Gynecology clinic. Results of this study will help determine which factors influence vaccination knowledge and attitudes. This may help improve future vaccination tools.


Eligibility Criteria:
Inclusion Criteria:

* all women attending gynecology clinic

Exclusion Criteria:

* none
Factor XA - Inhibition in RENal Patients With Non-valvular Atrial Fibrillation - Observational Registry

The multicenter registry will collect clinical data from 1600 patients with non valvular atrial fibrillation (NVAF) and chronic kidney disease (eGFR 15-49 mL/min per 1.73 m2).

The overall objective of this registry is to assess chronic kidney disease (CKD) progression and clinical outcomes with regard to anticoagulation strategies in NVAF patients with eGFR 15-49 mL/min per 1.73 m2 in routine clinical practice.

This is a prospective registry allowing a structured, non-interventional collection of data. Participating physicians will not be subject to any instructions with regard to the diagnosis and therapy of their patients. All patient treatment is carried out within clinical routine, at the discretion of the physician and according to existing treatment guidelines.

This registry will be carried out as an investigator-initiated, multicentre, prospective, non-interventional and observational registry at approximately 160 sites in Germany, Austria, Switzerland, France, Belgium and Luxembourg.

The registry will collect clinical data of approximately 1600 patients with CKD (eGFR 15-49 mL/min per 1.73 m2) and NVAF receiving rivaroxaban, OAC with VKA, or no AC therapy, who are prospectively followed for a flexible duration with a minimal follow-up duration of 12 months until study end is announced (planned minimum 360 days / planned maximum 84 months).

The plan of the registry is to include at least 1600 patients with CKD and NVAF and rivaroxaban therapy or VKA therapy or no AC therapy.

The aim is to include at least 700 patients with rivaroxaban therapy and VKA therapy, respectively. Into the exploratory treatment arm of patients receiving no AC therapy about 100 patients will be included.

Eligibility Criteria:
Inclusion Criteria:

* male and female patients, age ≥ 18 years
* CKD with eGFR 15 - 49 mL/min per 1.73 m2
* non-valvular atrial fibrillation (NVAF) with indication for anticoagulation therapy
* a treatment strategy for the ≥ 3 previous months before enrolment with either: rivaroxaban or VKA (OAC cohorts) or no anticoagulation (no AC cohort)
* informed consent
* availability for follow up
* life expectancy of ≥6 months

Exclusion Criteria:

* exclusion criteria according to the local product information for the respective anticoagulation treatment
* planned treatment with other anticoagulants
* expected renal-replacement therapy within the next 3 months
Clinical Trial Evaluating Chlorine e6 Derivative-mediated Antimicrobial Photodynamic Therapy as a Treatment for Denture Stomatitis

Objective: This randomized clinical trial assessed antimicrobial Photodynamic Therapy (aPDT) mediated by Photodithazine (PDZ) to treat patients with denture stomatitis (DS). Methodologies: Patients with DS were randomly assigned to the groups: aPDT (n=30) and nystatin (NYS, n=35). aPDT patients received 6 aPDT sessions, three times a week for 15 days, which involved PDZ (200 mg/L) topical application (20 min) on the palate and upper denture, followed by light emitting diode (LED) illumination (660 nm, 50 J/cm²). NYS patients were instructed to rinse one dropper of this medication for one minute, four times a day, for 15 days. Microbiological collections of dentures and palates were performed and cultured on blood agar and CHROMAgar Candida. Microbial viability was determined, and photographs of the palates were taken for clinical evaluation. Data were analyzed by Repeated Measure Linear Model and Bonferroni (p≤0.05).


Eligibility Criteria:
Inclusion Criteria:

* Edentulous denture wearers clinically diagnosed with denture stomatitis.

Exclusion Criteria:

* patients who received antibiotics, antifungal or steroids in the past 3 months prior to the beginning of the research, women in the reproductive phase, patients who had worn the same denture in the past 10 years, diabetics, anemics, immunocompromised and under cancer treatment.
A Behavioral Intervention for Depression and Chronic Pain in Primary Care (Relief-Hybrid)

Chronic pain and depression frequently co-exist in late and mid-life and contribute to increased disability, high health care costs, psychiatric comorbidity, and suicide. Older and middle-aged depressed-pain patients: a) are mainly treated in primary care practices; and b) are often prescribed medication, which increases the risk for addiction to opioids and benzodiazepines. Despite the need and desire by the patients and providers for primary care behavioral intervention, behavioral interventions are scarce in primary care.

To address this need, Relief-Hybrid was created. Subjects are randomized to either the Relief-Hybrid intervention or to Referral to Mental Health/Usual Care. Subjects in both arms will complete research assessments at 6, 9, and 12 weeks. Subjects in the Relief-Hybrid arm will receive 5 weekly sessions with the study therapist (licensed social workers, LCSWs) and 4 self-administered, mobile technology-assisted sessions.


Eligibility Criteria:
Inclusion Criteria:

* 50 years or older
* PHQ-9 score greater or equal to 10
* Chronic pain (non-cancer related, most days over the past 3 months)
* Capacity to consent

Exclusion Criteria:

* DSM-5 Axis 1 diagnoses other than depression and anxiety disorders
* Montreal Cognitive Assessment (MoCA) \< 24
* Active suicidal ideation (MADRS item #10 greater or equal to 4
* Severe or life-threatening medical illness
* Patients on psychotropics, opioids or benzodiazepines will be included if they do not meet DSM-5 criteria for opioid, anxiolytics or other substance abuse disorders
Hepatectomy for Early-stage HCC Patients With CSPH

Clinically significant portal hypertension (CSPH) can affect the surgical prognosis of early-stage (BCLC stage A) HCC. An additional stage, such as the BCLC stage A-B, can be considered.


Eligibility Criteria:
Inclusion Criteria:

HCC was diagnosed by two experienced pathologists in Child-Pugh grade A/B negative resection margin Initial diagnosis of HCC in the patients

Exclusion Criteria:

Distant transfer Not HCC
Exercise for Elderly Lymphoma Patients

This pilot study was designed in a real-life setting to establish the feasibility, the safety and the activity of a supervised and combined Exercise Training (ET) program in adult and elderly lymphoma patients undergoing cancer-treatments.

Eligible patients were assigned to the ET group. All the patients eligible for exercise but not partiticpating to the ET program because of logistical reasons, were considered as the control group. All clinical outcomes were assessed before exercise training (T0), 3 (T1) and 6-months (T2) after the beginning of the exercise.

Eligibility Criteria:
Inclusion Criteria:

* ≥18-80 years old, histologically conﬁrmed HL or NHL, patients in need of first or subsequent lines of systemic treatment and with a long-life expectancy

Exclusion Criteria:

* Patients were excluded if they had less than 4 months of anti-cancer treatment to be delivered, severe orthopaedic, cardiac, pulmonary, or cognitive impairment, osteolytic lesions with the risk of fracture, cachexia or if they were ≥ 65 years and frail on the basis of comprehensive geriatric assessment
Does Additional Use of Preoperative Azithromycin Decrease Posthysterectomy Infections

During hysterectomy bacteria may enter into the peritoneal cavity through vaginal opening and contaminate the healing tissues. The risk for deep infection after hysterectomy is about 5%. By reducing post-hysterectomy infections, it is possible to reduce individual burden of disease in addition to the direct and indirect financial costs. This study primary aim is to assess if prophylactic preoperative use of azithromycin in addition to generally used cefuroxime decreases post-hysterectomy infections as compared to cefuroxime only prophylaxis during 30 days after hysterectomy. Secondary aim is to assess if there is change in post-hysterectomy superficial infections, urinary tract infections, or post-operative fever between the cohorts and to report possible side-effects of the used antibiotics. In addition, the study finds out a possible role of bacterial vaginosis and microbiome n post-hysterectomy infections.


Eligibility Criteria:
Inclusion Criteria:

* Women undergoing hysterectomy for benign indication in University Hospitals (Helsinki University Hospital, Turku University Hospital, Tampere University Hospital, Oulu University Hospital and Kuopio University Hospital) who have not any contraindications for azithromycin or cefuroxime.

Exclusion Criteria:

* Inability to understand the study protocol.
* Allergy for either cefuroxime or azithromycin.
* Congenital or acquired prolonged Q-T-corrected interval. All the participants will be asked about arrhythmias and whether they have congenital arrhythmias in the family,
* Electrocardiogram will be checked for all the participants.
* Use of medicines that may prolong Q-T-corrected interval (class Ia arrhythmia medications, quinidine, procainamide, and class III arrhythmia medications dofetilide, amiodarone and sotalol).
* Use of selective serotonin reuptake inhibitor medication and prolonged Q-T-corrected interval.
PRE- MISTIC: MRI and Cine Imaging to Improve Staging of Tumors in the Colon

At this moment, we use CT and endoscopy to clinically stage colon tumours. Unfortunately, the combination of these imaging techniques is highly inaccurate. 40% of advanced pathological colon tumours (so called T4 tumours) are not staged as a T4 tumour pre-operatively. Preoperative or neoadjuvant chemotherapy (NAC) has improved outcomes in other gastrointestinal cancers and seems to be a promising pretreatment for colon tumours. To implement NACin colon tumours, we first need to stage the colon tumours with much higher accuracy. MRI sequences and cine imaging hold promise to provide more accurate staging of colon tumours.


Eligibility Criteria:
Inclusion Criteria:

* Patients with clinical suspicion for T3 or T4 tumor based on standard clinical work-up with endoscopy and CT-scan
* Age \> 18 years
* WHO Performance status of 0-2

Exclusion Criteria:

* Patients with contraindications for MRI
* Patients with clinical contraindications to undergo colon surgery
* Patients receiving neoadjuvant therapy prior to surgery
* Patients with known allergy to iodine or gadolinium contrast
* Patient with contra-indication for contrasts based on kidney failure Neoadjuvant therapy is currently not the standard of care for advanced colon carcinoma, and applied only in selected cases or as part of a clinical trial. Because neoadjuvant therapy could result in tumor regression, thus impacting the gold standard of histological examination, patients selected for neoadjuvant therapy are excluded from this study.
Effectiveness of the Use of Lightback in Conventional Football Training.

Lightback is a patented device that allows instrumental stretching of the gluteal muscles. Football players overload this musculature and this type of device is effective and the cost/benefit ratio is high.

The intention is to carry out a randomised clinical trial to carry out a study on athletes to see the differences between a group of football players with their normal training and a group of football players with their normal training and the application of lightback beforehand.

The variables studied will be sprint speed in 20 and 40m, vertical jump height, hamstring muscle injuries throughout the season, triceps sural injuries throughout the season, internal and external hip ROM, dorsal flexion ankle ROM.


Eligibility Criteria:
Inclusion Criteria:

* Professional football players
* Age range 18 to 45 years
* Able to perform physical exertion without discomfort.

Exclusion Criteria:

* Football players recently injured or in an active recovery phase.
* Heterometrics
* Non-collaborators
* Alteration of sensitivity
Improving Relationships Using Motivational Interviewing

This research aims to optimize patient-clinician relationships through motivational interviewing training in a Federally Qualified Health Center (FQHC) to improve health outcomes for African American patients with Type 2 diabetes.

Motivational Interviewing (MI) is an evidence-based approach that has been demonstrated to increase both the patient engagement and activation necessary for effective management of chronic conditions, but is underutilized due to the inadequate training of and implementation by health professionals. This research aims to optimize patient-clinician relationships through MI training in a Federally Qualified Health Center (FQHC) to improve health outcomes for African American patients with Type 2 diabetes. MI training and cuing in this study will make use of a human-artificial intelligence (AI) teaming solution, Real-time Assessment of Dialogue in Motivational Interviewing (ReadMI), a tool that uses natural language processing to provide automatic and immediate metrics relevant for patient-clinician interaction.

Eligibility Criteria:
Inclusion Criteria:

* Eligible participants are residents in Family Medicine and Internal Medicine residency programs at Wright State University who will be recruited to participate in the study.

Exclusion Criteria:

* None

Note: Patients of these participating residents will be invited to participate in the study by providing survey and health data at specified intervals, but these patients will not be the direct recipients of any intervention in this study. Eligible patients will be self-identifying African American individuals ages 18 and over with a diagnosis of Type 2 diabetes, and are patients of either Family Medicine or Internal Medicine residents participating in this study. The target number of patients is 200.
Taking a Look at Patient Experiences In Rectal Cancer Clinical Trials

The primary objective of this research study is to explore the barriers encountered by specific demographic groups of rectal cancer patients during the engagement in clinical trials, which historically lack diverse representation.

By carefully analyzing data from various demographic perspectives, this study aims to uncover patterns that impact the experiences of future rectal cancer patients. Active involvement in this crucial research is of utmost importance, as it can offer unique insights to enhance the participation and completion rates of rectal cancer patients in clinical study.


Eligibility Criteria:
Inclusion Criteria:

* Confirmed diagnosis of rectal cancer
* Aged ≥ 18 years old and ability to provide written informed consent obtained prior to participation in the study and any related procedures being performed
* No prior treatment for rectal cancer

Exclusion Criteria:

* Pregnant or lactating woman
* Inability to provide written informed consent
* Enrolled in another research study
Retrospective Analysis of Survival in Adult MRD Positive Acute Lymphoblastic Leukemia Patients

A retrospective analysis of historical data looking at relapse free survival and overall survival rates in adult philadelphia negative B-pre-cursor acute lymphoblastic leukemia patients.

A retrospective observational study reviewing historical survival data (relapse free survival and overall survival) for adult patients who have philadelphia negative B-precursor acute lymphoblastic leukemia, and are in complete hematological remission with minimal residual disease.

Eligibility Criteria:
Inclusion Criteria:

* patients with Philadelphia-negative B-Precursor Acute Lyphmoblastic Leukemia in complete hematological remission defined as less than 5% blasts in bone marrow after at least 3 intensive chemotherapy blocks (i.e. any standard or investigational regimen according to adult protocols as long as 3 age appropriate chemotherapy blocks were given, this also includes relapse treatment
* detection of minimal residual disease (molecular failure or molecular relapse) at a level of greater than or equal to 10\*(-4) by PCR or greater than or equal to 10\*(-3) by flow cytometry at a reference lab
* Age 15 or greater at time of initial diagnosis with acute lymphoblastic leukemia. For patients aged 15-17 treatment according to adult protocols is required
* Initial diagnosis in the year 2000 or later
* History of acute lymphoblastic leukemia treatment (including response to first therapy, number of prior relapses) is available
* Relapse status and disease follow up after timepoint of minimal residual disease detection is available

Exclusion Criteria:

* Patients with extramedullary disease at timepoint of minimal residual disease detection
* Use of Blinatumomab within 18 months of minimal residual disease detection
* Allogeneic hematopoietic stem cell transplantation prior to minimal residual disease detection at the required level
Svangerskap, Arv, Og Miljo (Pregnancy, Heredity and Environment)

This proposal describes a population-based case-control study of all Norwegian infants born with cleft lip or palate over a five-year period. The study will be jointly supported by the U.S. National Institute of Environmental Health Sciences (NIEHS), and the Norwegian National Institute of Public Health (SIFF) and Medical Birth Registry of Norway (MBR). Cases will be identified through the two surgery clinics that treat all clefts in Norway. Controls will be randomly selected from all live births through the MBR. Mothers will complete two selfadministered questionnaires; one regarding exposures before and during pregnancy, the other their diet during their early months of pregnancy. Biological specimens for DNA testing (blood samples, buccal swabs) will be collected from cases, controls and mothers in order to describe possible gene-environment interactions. With 750 cases and 1100 controls, this will be one of the largest and most complete field studies of facial clefting yet conducted.

This proposal describes a population-based case-control study of all Norwegian infants born with cleft lip or palate over a five-year period. The study will be jointly supported by the U.S. National Institute of Environmental Health Sciences (NIEHS), and the Norwegian National Institute of Public Health (SIFF) and Medical Birth Registry of Norway (MBR). Cases will be identified through the two surgery clinics that treat all clefts in Norway. Controls will be randomly selected from all live births through the MBR. Mothers will complete two selfadministered questionnaires; one regarding exposures before and during pregnancy, the other their diet during their early months of pregnancy. Biological specimens for DNA testing (blood samples, buccal swabs) will be collected from cases, controls and mothers in order to describe possible gene-environment interactions. With 750 cases and 1100 controls, this will be one of the largest and most complete field studies of facial clefting yet conducted.

Eligibility Criteria:
* INCLUSION CRITERIA:

We expect to enroll about 150 infants with cleft lip or palate annually for five years (550 with cleft lip with or without cleft palate, and 200 with cleft palate alone)

Controls will be chosen randomly from all Norwegian live-births through the Medical Birth Registry.

EXCLUSION CRITERIA:

There will be no exclusion by race, sex or ethnic group.
A Study of AMG 706 or Bevacizumab, in Combination With Paclitaxel Chemotherapy, as Treatment for Breast Cancer

To determine if treatment with paclitaxel plus AMG 706 is superior to paclitaxel plus AMG 706 placebo in subjects with HER2 negative locally recurrent or metastatic breast cancer. Also to estimate differences between treatment with paclitaxel plus AMG 706 and paclitaxel plus bevacizumab.


Eligibility Criteria:
Inclusion Criteria:

* Histologically or cytologically confirmed adenocarcinoma of the breast with locally recurrent or metastatic disease.
* Measurable disease by RECIST guidelines.
* Tumor (primary or metastatic) must be HER2 negative.
* Adequate organ and hematologic function. Exclusion:
* Taxane treatment within 12 months prior to registration.
* Prior chemotherapy for locally recurrent or metastatic breast cancer (prior endocrine therapy is permitted).
* Prior radiation therapy, radiofrequency ablation, percutaneous cryotherapy or hepatic chemoembolization on all sites of measurable disease.
* Current or prior history of central nervous system metastases.
* Peripheral neuropathy ≥ grade 2 (CTCAE v3.0) at registration.
* History of arterial or venous thrombosis within 1 year prior to registration.
* History of bleeding diathesis or bleeding within 14 days of registration.
* Uncontrolled hypertension (systolic \>145 mmHg; diastolic \>85 mmHg).
* Clinically significant cardiac disease within 12 months of registration.
* Known HIV positive, hepatitis C positive or hepatitis B surface antigen positive.
* Prior treatment with VEGFr targeted therapies.