cyrilzakka/clinical-trials huggingface dataset:
Liver Resection for Patients With Hepatocellular Carcinoma and Impaired Liver Function

Hepatic dysfunction limits the therapeutic options for hepatocellular carcinoma (HCC), which is closely associated with patient prognosis. Established practice guidelines for patients with HCC and impaired liver function are lacking. The treatment allocation in these populations is heterogeneous and remains controversial. This study compared the survival benefits of liver resection (LR) and transarterial chemoembolisation (TACE) in patients with HCC and impaired liver function.


Eligibility Criteria:
Inclusion Criteria:

* patients with HCC who received conventional LR or TACE

Exclusion Criteria:

* （1） presence of portal vein tumour thrombosis (PVTT), hepatic artery, biliary duct or inferior vena cava invasion
* （2） extrahepatic spread (EHS)
* （3） albumin-bilirubin grade 1 or 3
* （4） Eastern Cooperative Oncology Group Performance Status (ECOG-PS) \>1
* （5） tumour number \>3
* （6） other tumours or severe cardiac, cerebral, and renal insufficiency
* （7）ascites, hepatic encephalopathy, and jaundice
Hip Abductor Strengths, Limping and Trochanteric Tenderness After Hip Arthroplasty Due to Femoral Neck Fracture

A prospective cohort study to compare the direct lateral and poster-lateral approach concerning abductor function. Patients admitted with a femoral neck fracture operated with a hemiarthroplasty through a direct lateral or a poster-lateral approach were screened for inclusion. Patients with altered mental status SPMSQ \>7, pathological fractures, non-walkers were excluded.

Those who fulfilled the inclusion criteria and non of the exclusion criteria were followed 1 year postoperatively by clinical examination. Sample size were estimated to 30 patient in each group. Primary outcome variables were trendelenburg test, abductor strength measured with dynamometry, trochanteric tenderness measured with algometry and palptation.


Eligibility Criteria:
Inclusion Criteria:

* Displaced femoral neck fracture
* Walker
* Hemarthroplasty
* Preiffer test \>7/10

Exclusion Criteria:

* Pathological fracture
* Non-walker
* Pfeiffer test \<7/10 indicating mental alteration.
Low Dose β-carotene Supplementation Diminishes Oxidative Stress in Type 2 Diabetics and Healthy Individuals

Since diabetes has multiple etiologies and oxidative stress one of the proposed mechanisms, the objective is to determine the effect of supplementation with β-carotene to type 2 diabetics and healthy individuals, on iron metabolism, oxidative balance, and antioxidant plasma capacity, using doses similar to the daily nutritional requirement.

Type 2 diabetes is a chronic, multifactorial disease, and oxidative stress one of the pathophysiological mechanisms associated with its appearance and development. The objective was to determine the effect of supplementation with β-carotene to type 2 diabetics and healthy individuals, on iron metabolism, oxidative balance, and antioxidant plasma capacity, using doses similar to the daily nutritional requirement.

A total of 117 volunteers participated in the study. Type 2 diabetics (34) and healthy individuals (24), received 6 mg β-carotene for 45 d, and were compared to similar non-supplemented diabetic (33) and control (26) groups. Blood samples were taken at the beginning, end and 30 days after finishing supplementation, to determine hemoglobin, hematocrit unsaturated iron binding capacity, total iron binding capacity, transferrin saturation, ferritin, glycemia, glycosylated hemoglobin, cholesterol, triglycerides, HDL, LDL, oxidized LDL, copper, zinc, TBARS, FRAP, nitrites, GPx, SOD, folates, retinol and β-carotene.

Eligibility Criteria:
Inclusion Criteria:

Patients with a diagnose of Type 2 diabetes mellitus of at least 5 years of diagnosis, in treatment with oral hypoglycemics Patients in regular control (once a month) in the Hospital

Exclusion Criteria:

* Hospitalized patient
* Diabetic patient with diabetes related acute complications (ketoacidosis, hyperosmolar coma)in the 3 months previous to the study.
* Individuals with infections that required antibiotics in the 3 weeks previous to the study.
* Individuals with antibodies anti-insulin, autoimmune diseases or in treatment with immunosuppressive drugs.
* Individuals with viral infections such as hepatitis B, hematological, renal or hepatic diseases.
* Pregnancy
Observational Study of Patients Using Levemir® or Insulatard® as Start Insulin for Treatment of Diabetes

This trial is conducted in Europe. The aim of this observational study is to evaluate the glycaemic control, weight change and hypoglycaemic effects in patients with type 2 diabetes with Levemir® compared to Insulatard® under normal clinical practice conditions.


Eligibility Criteria:
Inclusion Criteria:

* Type 2 diabetes failing on oral blood glucose lowering therapy, and requiring insulin therapy.

Exclusion Criteria:

* Type 1 diabetes
* Previous use of insulin
Study To Investigate If Embody's Retinol Gummies Improve The Early Signs Of Skin Aging And Overall Skin Health

The Embody retinol study is a single-arm clinical trial on skin aging prevention and adult acne. The purpose of this study is to determine the effect of a retinol gummy in adults aged 18-45 on skin aging and overall skin health.

Embody has developed a retinol gummy with the aim to improve the appearance of early signs of aging, such as fine lines, dark spots, and sagging. Embody's retinol gummy has also the goal to reduce the overall frequency of adult acne and an improvement of overall skin health by promoting hydrated, brightened skin. The study aims to collect self-reported outcomes and photographic images to understand the assessment of the efficacy of treatment from the participant's perspective, and if participants see an improvement in their fine lines, wrinkles, dark spots, and sagging.

Eligibility Criteria:
Inclusion Criteria:

* Male or female between 18-45 years old
* Must be in good general health
* May experiences adult acne and/or early-stage wrinkles that are not treated by topical or oral prescription drugs/medication
* Must maintain a basic skincare routine
* Must discontinue the use of other dietary supplements
* Must be willing to comply with the requirements of the protocol
* Is able to communicate in English
* Is willing to skip their normal skincare routine
* Must provide written informed consent form (ICF)
* Is willing and able to share feedback and take skin pictures via the used technology portal

Exclusion Criteria:

* Unwilling to provide consent
* Unwilling to skip their normal skincare routine
* Unwilling to follow the routine of the protocol
* Use of other oral retinoids
* Use of prescription medication relevant to the skin
* Undergoing any cosmetic procedures during the study including Botox, laser or chemical treatments
* Deep-set of wrinkles
* History of the following medical conditions or diseases:
* Kidney disease
* Liver disease
* Alcohol abuse
* Use of prescription drug (topical or oral) that is targeted at any sort of skin condition (for example retinoids)
* Any known allergies/sensitivities to nuts
Adolescent and Young Adulte Scoliosis

Thoracic hypocyphosis and greater lumbar lordosis after correction of idiopathic scoliosis in adolescents and young adults may adversely affect overall sagittal alignment and increase the risk of proximal junctional kyphosis.

The objective of this study is to analyze surgical corrections and maintenance of correction over time using modern posterior instrumentation strategies by comparing technical developments.


Eligibility Criteria:
Inclusion criteria:

* Major subjects\> 18 years old
* Subject with a surgical indication for arthrodesis and surgical correction of adolescent or young adult scoliosis
* Subject not having expressed his opposition, after information, to the reuse of his data for the purposes of this research.

Exclusion criteria:

* Subject having expressed opposition to participating in the study
* Subject under guardianship or guardianship
* Subject under safeguard of justice
Periodontally Accelerated Osteogenic Orthodontics With BMP2

rhBMP-2 has the potential to function as a regenerative material in periodontally accelerated osteogenic orthodontics (PAOO). This study aimed to assess the effects of PAOO with BMP-2 on outcomes such as treatment period, bone density, healing and pain.

Subjects were randomly assigned into each of the following experimental groups; C+BMP: corticotomy with 0.5 μg/mL rhBMP-2 and C: corticotomy only. Clinical parameters included recording the duration of treatment period, visual analogue scale (VAS) scores and early healing index (EHI) scores. The evaluation of bone density was performed at baseline, 3 months and 6 months by using RVG.

Eligibility Criteria:
Inclusion Criteria:

* 30 subjects with moderate crowding of lower incisors based upon Little's index and willing to undergo undergoing orthodontic treatment with extraction therapy of lower 1st premolars and PAOO were included in the study.

Exclusion Criteria:

* Smokers and subjects with severe crowding of anterior teeth, periodontitis and systemic diseases were excluded from the study.
Gene Therapy for ADA-SCID Using an Improved Lentiviral Vector (Ivlv-ADA)

This is a Phase I/II trial of in vivo lentiviral gene therapy for treating adenosine deaminase severe combined immunodeficiency (ADA-SCID) using a self-inactivating lentiviral vector (LV) ivlv-ADA to functionally correct the genetic defect. The primary objectives are to evaluate the safety and efficacy of the direct intravenous (iv) LV gene therapy protocol.

This clinical trial will evaluate safety and efficiency of an improved LV system for delivering a therapeutic gene to patients with severe combined immunodeficiency (SCID) due to a defective adenosine deaminase (ADA) gene. This gene encodes for the adenosine deaminase enzyme, which is essential for the proper growth and function of infection-fighting white blood cells called T and B lymphocytes. Patients who lack this enzyme are vulnerable to frequent and severe infections.

ADA-SCID patients are normally rescued by a bone marrow transplant (BMT) from a matched healthy donor. However, matched donors are difficult to find and donor BMT is associated with high risk. This trial aims to treat ADA-SCID via direct intravenous (iv) injection of a safety and efficiency improved self-inactivating LV carrying a functional ADA gene (ivlv-ADA) to correct the genetic defect. By direct iv injection of ivlv-ADA, the defective immune cells and blood stem cells in the body can be modified to exhibit ADA activity and correct the immunodeficiency.

The primary objectives are to evaluate the safety of the improved ivlv-ADA, the iv LV gene transfer clinical protocol and the efficacy of immune recovery in patients to overcome frequent infections present at the time of treatment. We will assess the in vivo lentiviral gene transfer efficiency and the long-term effect of this gene transfer procedure.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of classical ADA-SCID based on:

  * A proven defective adenosine deaminase (ADA) gene as defined by direct sequencing of patient DNA.
  * T-cell immune deficiency defined as one or more of the following: CD3+ autologous T cells \< 300/ul, or less than 50% of normal value for in vitro mitogen stimulation, or absent proliferation in vitro to antigens.
* With severe infections, including but not limited to: pneumonitis; protracted diarrhea requiring total parenteral nutrition; infection with herpes viruses or adenovirus or fungus; disseminated BCG infection.
* No cytogenetic abnormalities (medullary karyotype) and no detection of main rearrangements associated with acute leukemia of children.
* No prior allogeneic stem cell transplantation.
* Life expectancy ≥ 2 months.
* Negative for HIV infection.
* Written, informed consent obtained prior to any study-specific procedures.

Exclusion Criteria:

* None
E3810-A001-312: Efficacy and Safety of 10 mg Rabeprazole for Treating Heartburn in Frequent Sufferers

The purpose of this study is to investigate the safety and efficacy of rabeprazole 10 mg in treating frequent heartburn.

This is a multicenter, double-blind, randomized, placebo-controlled study to investigate the safety and efficacy of rabeprazole 10 mg in treating frequent heartburn. The study will last for up to five weeks and consists of the following three phases: a one to two week screening period that includes a one week, single-blind, placebo run-in phase, a two week double-blind, randomized treatment phase, and a one week single-blind, placebo follow-up phase.

Eligibility Criteria:
Key Inclusion Criteria:

1. Male or female patients \> 18 years of age.
2. If female, not of childbearing potential by reason of surgery or menopause, or of childbearing potential, but using an approved method of contraception since the last menstrual period. Females of childbearing potential must have a negative serum pregnancy test before starting the study.
3. Patients must report a history of heartburn at least two days per week over the past month.

Key Exclusion Criteria:

1. History of erosive esophagitis verified by endoscopy.
2. History of gastroesophageal reflux disease (GERD) diagnosed by a physician.
3. Patients who have a history of Barrett's esophagus or esophageal stricture.
4. Evidence of any medical condition that may interfere with the conduct of the study, the interpretation of study results, or the health of the patient during the study.
5. Patients who require continuous use of proton pump inhibitors, histamine receptor (H2) blockers, or prokinetics. Prior intermittent use of these agents is permitted if they are discontinued at least three days prior to the run-in phase. The H2 blocker, cimetidine (Tagamet®), must be discontinued for at least seven days before the study drug is administered.
Remote Programming of Cardiac Implantable Electronic Devices 2

Cardiac Implantable Electronic Devices (CIEDs) such as pacemakers and implantable cardioverter defibrillators need to be regularly and systematically interrogated and reprogrammed to ensure proper functioning. While remote monitoring allows for partial interrogation at a remote location, full CIED check-up and reprogramming is only possible when the patient visits a cardiologist capable of performing device programming. This can be challenging for patients and may cause unnecessary delays, particularly in settings of limited resources, enforced physical distancing, and quarantines. The aim of this study is to evaluate our previously validated remote programming solution (REACT study, NCT05366660) in outpatient device clinics which are close to the patient's home but remote from the CIED expert.

Remote programming of a CIED offers multiple advantages such as shorter travel distances for the patient, reduced need for presence of specialized cardiologists and the possibility to offer expert support at remote locations or developing countries. Remote programming may be a way to mitigate disparities in health care access. The remote surveillance centre of CHU Bordeaux has previously developed and validated (REACT study, NCT05366660) a remote control system for CIED programmers that eliminates the physical presence of a cardiologist during the interrogation and programming process. The aim of this study is to evaluate this solution for the remote evaluation of CIEDs at the benefit of inhabitant of medically underserved population. Enrolled patients living \>100km from the Bordeaux University Hospital will undergo there an in person evaluation of their CIED which will be compared six months later with a remote evaluation in a nurse office close to the patient's home.

Eligibility Criteria:
Inclusion Criteria:

* Patient of both sexes over the age of 18
* Patients implanted with a cardiac pacemaker or an automatic defibrillator and an indication for device check-up (interrogation ± programming)
* Patient followed at the Bordeaux University Hospital but living more than 90km away
* Person beneficiary of social security insurance
* Informed consent confirmed in writing (at the latest on the day of inclusion and before any examination required by the research)
* Women of procreating age with effective contraception

Exclusion Criteria:

* Patients younger than 18 years old
* Patients who are incapable to understand the study design or to give informed consent.
* Pregnant or breastfeeding women
* Persons placed under legal protection
* Subject deprived of liberty on judicial or administrative decision
* Persons participating in another study who are still in their period of exclusion
Safety, Tolerability and Immunogenicity of Meningococcal C Conjugate Vaccine to Children 32 to 40 Months of Age

Safety, Tolerability and Immunogenicity of Meningococcal C Conjugate Vaccine to Children 32 to 40 Months of Age


Eligibility Criteria:
Inclusion Criteria:

* Healthy children

Exclusion Criteria:

* known hypersensitivity to any vaccine component
* significant acute or chronic infections requiring systemic antibiotic treatment or antiviral therapy within the past 14 days
* ascertained or suspected disease caused by N. meningitidis
* household contact with or intimate exposure to an individual with a positive culture of N. meningitidis serogroup C within the previous 60 days
A Study Comparing the Acceptability of Pentasa® Sachets Versus Pentasa® Tablets in Children With Crohn´s Disease

The primary objective of the clinical trial is the assessment of the acceptability of the new Pentasa formulation - PentasaR Sachets in comparison with the reference PentasaR tablets 500 mg in children with Crohn's disease. After the screening period (which includes medical history, physical examination, basic haematology, serum chemistry , urine analysis and stool microbiology , PCD Activity Index )patients will receive (visit I) Pentasa sachets 1g or Pentasa tablets 500mg for next 4 weeks according to the randomisation scheme in common dose 2× 1 g of PentasaR Sachets 1 g or PentasaR tablets 500 mg. The formulation of Pentasa will be switched at Visit 2, patients will receive the medication for next 4 weeks. Patients will record the acceptability of the both forms of the medication.

In 6 patients from each group (selected by the randomization), stool and urine will be taken to assess concentrations of mesalazine and N-acetylmesalazine during Visit 2 and Visit 3. Adverse events will be recorded during the whole course of the treatment period.


Eligibility Criteria:
Inclusion Criteria:

* Established diagnose of Crohn's disease
* Age 8-18 years, both sexes
* Weight above 40 kg
* Oral maintenance treatment with 5-ASA and any concomitant antinflammatory medication (maintained at the same dose during the study) before inclusion is permitted,
* written informed consent obtained (patient and his/her guardian)

Exclusion Criteria:

* Patients with a history of allergy to salicylates
* Patients with known significant hepatic or renal function abnormalities
* Positive enteric pathogens in stool (Salmonella, Shigella, Yersinia, Campylobacter)
* Pregnant or lactating women
* Patients with a known history of disease, including mental/emotional disorder, that would interfere with their participation in the study,
* Patients who participated in another clinical study in the last 3 months,
* Patients who are unable to comply with the requirements of the protocol
* Patients who are unable to fill in the diary cards
Tailoring Patient Education to Perceived Risk for Falls in Hospitalized Oncology Patients

This randomized pilot clinical trial studies tailored patient educational intervention or standard education in assessing perceived risk for falls in hospitalized oncology patients. A tailored patient educational intervention may be more beneficial than standard education in preventing patients from falling by increasing the patient's knowledge of the risk factors for falling routinely and then providing education in deficit areas. Making patients more aware of the risk factors for falling may lead to greater engagement in preventative activities.

PRIMARY OBJECTIVES:

I. To evaluate the effect of a tailored, nurse-delivered intervention, as compared to the control group, on perceived risk for falls in hospitalized hematology-oncology patients.

II. To evaluate the effect of a tailored, nurse-delivered intervention, as compared to the control group, on confidence to minimize falls in hospitalized hematology-oncology patients.

III. To evaluate the relationship between patients' perceived risk for falling and their willingness to call for assistance with ambulation.

SECONDARY OBJECTIVES:

I. To evaluate the relationship between patients' perceived risk for falls and nursing risk assessments when using the standard hospital assessment tool and the investigator-designed perceived risk survey.

II. To evaluate the relationship between a patients' perceived risk for falls and sustaining a fall.

III. To evaluate patient satisfaction with the intervention.

OUTLINE:

All participants complete the Perceived Risk Survey comprising the participants' perceived risk for falls, their confidence to prevent a fall, and their willingness to ask for assistance at baseline and at 24 and 72 hours (or at discharge if stay is less than 72 hours) post-intervention. Patients are then randomized to 1 of 2 arms.

ARM I: Participants receive tailored education comprising one of four two-minute videos determined by which educational group the participant is placed in: high risk/high perception, high risk/low perception, low risk/high perception, or low risk/low perception. Participants also receive printed education sheets based on the participants' answers given on the Perceived Risk Survey and are tailored to the participants' perception of falls risk.

ARM II: Participants receive a generic educational instruction sheet on falls prevention and receive standard care by nurses comprising a falls risk assessment and verbal education.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of cancer
* Admitted to the third floor of Seidman Cancer Center (SCC)
* Cognitively intact (alert, oriented to self, place, and time, and able to participate in the intervention)
* Ability to speak, read, and comprehend English

Exclusion Criteria:

* Nonmalignant diagnosis
* Actively dying
* Patients with a physician order for bed rest