cyrilzakka/clinical-trials huggingface dataset:
UNiD Rods Register

Retro-prospective study allowing inclusion of patients with spinal deformities treated by patient-specific rods (UNiD).

This study aims to assess performance, clinical outcomes and safety

Despite decades of treatment and great diversity of instrumentation, the objective of sagittal spinal realignment in adult spinal deformity is achieved in only 38% of patients which reflects an inadequacy of the approach currently used.

Patient specific rods were created by Medicrea to address this gap and support surgeons in achieving what they planned to perform in terms of spinal correction based on preoperative X-rays analyses.

Beside to help surgeons in planning and to improve performance, the avoidance of manual bending is supposed to save time during surgery and to limit notches which should then reduce rod fractures responsible for surgical revisions.

A European register-like study has been set-up to assess radiological performance, clinical outcomes and revision rate following implantation of patient-specific rods in adult spinal deformities

Eligibility Criteria:
Inclusion Criteria:

* Patient operated with UNiD® Patient Specific rods from MEDICREA® INTERNATIONAL
* Patient affiliated to health care insurance (social security in France)
* Patient able to complete a self-administered questionnaire
* Patient able to sign a disclosure form or a non-opposition form

Exclusion Criteria:

* Patient not operated with Patient Specific rods from MEDICREA® INTERNATIONAL
* Pregnant patient
* Patient not affiliated to health care insurance (social security in France)
* Patient unable to sign a disclosure form
* Patient unable to complete a self-administered questionnaire
Biomarkers in Patients With Diffuse Large B-Cell Lymphoma Treated With Combination Chemotherapy With or Without Rituximab

RATIONALE: Studying samples of tissue from patients with cancer in the laboratory may help doctors identify and learn more about biomarkers related to cancer. It may also help doctors predict how well patients will respond to treatment.

PURPOSE: This research study is studying biomarkers in patients with diffuse large B-cell lymphoma treated with combination chemotherapy with or without rituximab.

OBJECTIVES:

* To identify genes predictive of clinical outcome (failure-free survival and overall survival) among patients with diffuse large B-cell lymphoma treated with CHOP or R-CHOP induction on ECOG-E4494 using the nuclease protection assay for measuring gene expression in paraffin-embedded tissue.
* To identify genes that change their prognostic profile with the addition of rituximab to CHOP chemotherapy.

OUTLINE: This is a multicenter study.

Unstained formalin-fixed, paraffin-embedded samples are analyzed for gene expression via nuclease protection assay.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Diagnosis of diffuse large B-cell lymphoma
* Treated with CHOP or R-CHOP on ECOG-E4494

PATIENT CHARACTERISTICS:

* Not specified

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics
Cognitive Stimulation in Elderly Individuals at Risk to Develop Dementia (Allena-Mente).

The Allena-Mente study is a randomized, controlled, single-blind trial assessing the efficacy of cognitive stimulation (CS) compared to an active control group, participating to sanitary education lessons (AC). This non-pharmacological intervention is delivered to Mild Cognitive Impairment (MCI) and cognitively healthy individuals with first-degree relative with dementia (NDFAM).

The experimental protocol was set up with a pilot study on healthy elderly individuals. Data from this pilot study will be excluded from the statistical analysis.

Sample size: a priori power analysis was performed to evaluate the sample size required for the study. MCI and NDFAM were considered separately for sample size calculation. For power calculation a two-tailed test was used and a significance level (α) and test power (1-β) were set at 0.05 and 0.8/0.9, respectively.

Randomization: The individuals belonging to MCI and NDFAM subgroup were randomly assigned to CS or AC group. The randomization was performed by a statistician blind to participants characteristics using the Random Allocation Software. Allocation ratio was set at 1:1, stratification was performed for birth cohort (≤1937 and ≥1938), education level (years of education ≤5 years and \>5 years).

Participants provided written informed consent before study participation.

Eligibility Criteria:
Inclusion Criteria:

* Positive diagnosis for mild cognitive impairment (MCI) according to Petersen's criteria;
* Cognitively healthy elderly individuals, having at least one first-degree relative affected by dementia (Alzheimer's Disease, pre-senile and senile dementia, vascular dementia) (NDFAM).

Exclusion Criteria:

* (Major physical illness) Compromission of motor performance of lower and upper limbs
* Medical conditions leading to clinical instability;
* Therapies that reduce cognitive and communicative abilities and consciousness;
* Perceptual disorders (sight, hearing)
* Language disorders
* Education level lower than 3 years
* Psychiatric and behavioral disorders
* Addiction to drugs or alcohol
A Study in Dentinal Hypersensitivity (DH) Participants to Assess the Efficacy of an Occluding Dentifrice.

This study will investigate the longitudinal efficacy of two experimental oral rinses, one containing 1.5% weight/weight (w/w) dipotassium oxalate monohydride (KOX) /0 Parts per Million (ppm fluoride) and the other 2.0% w/w KOX /45ppm fluoride, for the relief of dentinal hypersensitivity (DH), compared to a placebo oral rinse, when used as an adjunct to twice daily brushing with a standard fluoride toothpaste.


Eligibility Criteria:
Inclusion Criteria:

* Participants in good general health with no clinically significant/ relevant abnormalities in medical history or upon oral examination
* Pre-existing self reported and clinically diagnosed tooth sensitivity
* At screening a minimum of 20 natural teeth and at least two accessible, non-adjacent teeth (incisors, canines or pre-molars) preferably in different quadrants with a signs of facial/cervical gingival recession and/or signs of erosion or abrasion (EAR),tooth with modified gingival index (MGI) score =0 adjacent to the test area (exposed dentine) only and a clinical mobility of ≤1 and tooth with signs of sensitivity measured by qualifying evaporative air assessment (Y/N response).
* At baseline, a minimum of 2 non-adjacent accessible teeth (incisors, canines or premolars) with DH (qualifying tactile threshold Yeaple ≤ 20g, Schiff Sensitivity Score ≥ 2)

Exclusion Criteria:

* Participants with a known or suspected intolerance or hypersensitivity to study products
* Presence of chronic debilitating disease which could affect study outcomes
* Any condition which is causing dry mouth
* Use of an oral care product indicated for the relief of dentine hypersensitivity
* Participation in a DH treatment study in the 8 weeks prior to screening
* Taking daily doses of a medication/ treatment which could interfere with perception of pain or is causing dry mouth
* Require antibiotic prophylaxis for dental procedures
* Dental prophylaxis within 4 weeks of screening
* Treatment of periodontal disease within 12 months of screening
* Scaling or root planning within 3 months of screening
* Tooth bleaching within 8 weeks of screening
* Active caries or periodontitis
* Partial dentures, orthodontic appliances or dental implants which could affect study outcomes
* Pregnant and breast-feeding females
* Main Exclusions for Test Teeth: evidence of current or recent caries; treatment of decay within 12 months of screening; teeth with exposed dentine but with deep, defective or facial restorations; teeth used as abutments for fixed or removable partial dentures; teeth with full crowns or veneers, orthodontic bands or cracked enamel; sensitive teeth with contributing aetiologies other than erosion, abrasion or recession
Recurrent Bacterial Vaginosis and Vaginal Acidifying Gel Trial

Bacterial vaginosis (BV) is a common, complex clinical syndrome characterized by alterations in the normal vaginal flora. Bacterial vaginosis has been associated with a variety of adverse health outcomes including endometritis; post-abortion endometritis; nongonococcal, nonchlamydial pelvic inflammatory disease; and an increased risk of acquiring and transmitting HIV infection. In pregnancy, BV is associated with premature rupture of the membranes, chorioamnionitis, amniotic fluid infection, preterm labor, preterm birth, and postpartum endometritis. Several studies have documented increased postpartum complications in the newborn and infants. The etiology of BV is poorly understood but recurrence is quite common despite treatment. Documented recurrence rate of up to 30% within three months are reported. Small studies have shown that adding vaginal acidifying gel to standard antibiotic regimens may reduce recurrence rates of BV. We plan an RCT comparing standard antibiotic therapy to antibiotics plus vaginal acidifying gel. Our hypothesis is that the addition of an acidifying gel will decrease the chance of recurrence of BV within 3 months.

Women with recurrent BV will be randomly assigned to standard care of metronidazole vs metronidazole plus vaginal acidifying gel. Symptoms and presence of BV will be measured at followup.

Eligibility Criteria:
Inclusion Criteria:

1. All women of between 18-50 years of age.
2. Confirmed current diagnosis of BV using Amsel's criteria.
3. Women with at least total 2 confirmed episodes of BV including most recent episode (by Amsel's criteria) within a six month period or at least total three or more in the past twelve months

Exclusion Criteria:

1. Patient who received antibiotic therapy within the past two weeks.
2. Patients who had co-existing gonorrhea or Chlamydia infection
3. Any contraindications or sensitivity to taking the vaginal gel.
4. Allergy to metronidazole
5. Alcoholics or those unable to abstain from alcohol consumption.
6. Pregnancy
Side Effects of Bone Marrow Derived CD133 Transplantation in Cerebral Palsy

Cerebral palsy (CP) is condition, sometimes thought of as a group of disorders that can involve brain and nervous system functions such as movement, learning, hearing, seeing, and thinking.Cerebral palsy is caused by injuries or abnormalities of the brain. Most of these problems occur as the baby grows in the womb, but they can happen at any time during the first 2 years of life, while the baby's brain is still developing.Bone marrow derived stem cells are known as a effective therapy.

In this study the investigators evaluate the side effect of bone marrow stem cell transplantation in patients with cerebral palsy.

Our study evaluate the side effects of bone marrow derived CD133 cells transplantation in 4-12years old patients with cerebral palsy.first all the patients undergone a comprehensive evaluation(physical exam, serology tests,EEG,MRI,GMFM66).

After bone marrow aspiration,autologous stem cells prepare for each patient. In operation room ,the cells are transplanted by intrathecal injection. all the patients would be under observed to notice acute side effects and 3,6,9 and 12 months after injection they will be followed and evaluate by comprehensive tests.

Eligibility Criteria:
Inclusion Criteria:

1. A diagnosis of spastic quadriplegic CP
2. Children must be between the ages of 4 and 12 years
3. Children must be cleared by an orthopedic surgeon for risk of hip subluxation or dislocation and cannot have significant scoliosis (curvature \> 40 degrees)
4. Children must be seizure-free or seizure controlled

Exclusion Criteria:

1. Children who have a diagnosis of "mixed" types of CP (i.e. athetosis) or other movement disorders (i.e. ataxia)
2. Children who have had a selective dorsal rhizotomy, are presently are receiving intrathecal Baclofen, or have changed their spasticity medications in the past 6 months.
3. Children who have a metallic or electrical implants
Optimizing the Management of Postpartum Urinary Retention

A study aimed at characterizing the comparing duration of catheterization for treatment of postpartum urinary retention (PUR) and characterizing short and long-term pelvic floor symptoms in women who have PUR.

The purpose of the study is to compare clinical outcomes of women with bladder distension injuries due to postpartum urinary retention (PUR) who have varying duration of catheterization for initial treatment of postpartum urinary retention.

Hypotheses

1. Longer duration of therapeutic catheterization will be associated with resolution of postpartum voiding dysfunction in women who sustain severe bladder distension injuries due to postpartum urinary retention.

   Definition of resolution of postpartum voiding dysfunction:

   A. A post void residual volume of less than half of initial instilled volume on the first retrograde voiding trial, AND B. No need for re-treatment for urinary retention within 1 week
2. The incidence of postpartum urinary retention (PUR) will vary by route of delivery, with operative vaginal delivery having the highest incidence.
3. Risk factors for PUR will be related to intrapartum and delivery conditions

Eligibility Criteria:
Inclusion Criteria:

1. Age greater than or equal to 18.
2. Vaginal or cesarean delivery at term (37 weeks gestational age or later) of live-born infants.
3. English or Spanish speaking and reading.

Exclusion Criteria:

1. Adults unable to consent.
2. Women under the age of 18.
3. Women who are currently pregnant (All women in the study will have already delivered).
4. Prisoners or detained individuals.
5. Women who chronically use a urinary catheter for another medical condition.
6. Women with a neurological disease with bladder manifestations (examples: Cerebrovascular accidents, Multiple sclerosis, Parkinson disease, cerebral palsy).
7. Women with preeclampsia requiring magnesium treatment for seizure prevention.
8. Women with prior PUR
9. Women on anticholinergic medications.
10. Women who are actively being treated for a UTI.
Global and Regional Myocardial Strain and Power Output In Patients With Single Ventricles Using Novel MRI Techniques

The investigators are beginning a clinical research study here at UCSF to learn more about how hearts with single ventricles work. The investigators hypothesize that myocardial strain , as measured by cardiac MRI,in patients with single ventricles differs from normal hearts. This abnormality is associated with depressed cardiac power output and impaired exercise capacity. The study will utilize cardiac magnetic resonance imaging, exercise testing, and lung function testing to study how the single ventricle heart works so that in the future the investigators can improve how the investigators care for patients with this type of congenital heart disease.

The research protocol involves: Cardiac magnetic resonance imaging (MRI of the heart), exercise tests, and lung function tests. Some of these tests are routinely used to follow patients with single ventricles. Some of these tests are part of the research protocol. If you agree to participate in this study, these tests will be performed at UCSF. The results of the routine tests will be shared with your doctor.

Participation will require approximately 30 additional minutes to the cardiac MRI procedure to collect the research data. The exercise tests, and lung function tests time commitment will take about two hours.


Eligibility Criteria:
Inclusion Criteria:

* Anatomy: The investigators will enroll 10 patients with single right ventricles status post Fontan and 10 patients with single left ventricles status post Fontan.
* Age range: 5 patients in each group will be between the ages of 10-18 years of age and 5 patients in each group will be older than 18 years of age.

Exclusion Criteria:

* Study subjects will be excluded if there are any contraindications to MRI including permanent pacemaker, ICD, retained permanent wires, cerebral aneurysm clips, neurostimulators, insulin or infusion pumps, implanted drug infusion devices, bone growth/fusion stimulators, or cochlear implants.
* In addition, patients with implanted hardware that may lead to inadequate imaging, such as steel coils or ventricular septal defect occluder devices, will be excluded.
* Finally, patients with developmental delay or physical limitations precluding cooperation with the MRI or exercise test or patients with claustrophobia will be excluded. Patients will be asked if there is any chance that they are pregnant. If they are possibly pregnant, they will be excluded.
Erythropoietin Protects Very Preterm Infants Against Necrotizing Enterocolitis

This study evaluates the effect of repeated low-dose erythropoietin (EPO) treatment on necrotizing enterocolitis (NEC) in very preterm infants. Half of participants will receive EPO, while the other half will receive a placebo.

NEC is one of the most severe complications in preterm neonates and is associated with high morbility and mortality. Studies have reported that EPO treatment decreases the incidence and severity of experimental NEC in animal models. Evidence from previous clinical studies about the effect of EPO treatment against NEC have all been hampered by small numbers of patients. The study is to investigate whether repeated low-dose EPO protects against NEC. Preterm infants with gestational age ≤32 weeks who are admitted to neonatal intensive care units within 72 hours after birth are randomized to EPO (500IU/kg, intravenously every other day for 2 weeks) or control group (the same volume of saline). Primary outcome is the incidence of NEC at 36 weeks of corrected age. Secondary outcome is growth and neurodevelopment at 18 months of corrected age in infants with NEC.

Eligibility Criteria:
Inclusion Criteria:

* Preterm infants with gestation age ≤ 32weeks
* Within 72 hours after birth
* Written informed consent obtained from parents

Exclusion Criteria:

* Genetic or metabolic diseases
* Congenital abnormalities
* Polycythemia
* Intracranial hemorrhage grade III/IV
* Unstable vital signs (such as respiration and circulation failure)
Characterization of Laryngeal Contact Granulomas: Retrospective Analysis of Symptoms, Promotive Factors and Therapy

Retrospective analysis of data from patients with laryngeal contact granulomas in order to identify possible differences and/or similarities between the cases and in order to determine whether and which conclusions can be drawn on disease and therapy.

This is a retrospective analysis of data from patients with laryngeal contact granulomas in order to identify possible differences and/or similarities between the cases and in order to determine whether and which conclusions can be drawn on disease and therapy.

Eligibility Criteria:
Inclusion criteria:

Laryngeal contact granuloma in adults with documentation of symptoms, possible causes, therapy and outcome

Exclusion criteria:

Incomplete information on the diagnosis laryngeal contact granuloma (symptoms, promotive factors, findings)
Postoperative Delirium in Cardiac Surgery ICU

Postoperative Delirium (POD) is a common complication in patients after cardiac surgery, which is associated with short-term prognosis and long-term quality of life. Due to the lack of specific treatment, prevention is the most effective strategy to reduce delirium. Risk assessment greatly contributes to guide prevention by stratifying the risk of the POD. However, the high-quality risk assessment tools are still sparse, and the combination of risk assessment and stratified prevention has not been applied to the management of delirium after cardiac surgery. In the previous work, we found the predictive value of preoperative cardiac function on POD, and found a critical value. On the basis of previous research, this project will learn from previous studies on risk factors of POD, and deeply explore potential predictors. Furthermore, we will develop and validate POD risk prediction model, and then develop it into a visual evaluation system. In addition, based on the theory of risk management and risk assessment tools, using the concepts and methods of evidence-based medicine, the risk assessment system and stratified management program of POD will be formed and evaluated by expert discussion meetings. It is expected that the risk assessment system and stratified management program constructed by this project could simply and quickly screen high-risk patients and carry out timely intervention, so as to reduce the incidence of POD, improve patients' prognosis and the quality of life after cardiac surgery.


Eligibility Criteria:
Inclusion Criteria:

* Aged above 18
* Patients after cardiac surgery
* Admitted to ICU after surgery

Exclusion Criteria:

* Preoperative delirium or dementia patients
* Unable to fully participate in delirium testing, including blind, deaf, illiterate or inability to understand Chinese
* Undergoing surgery procedures do not require admission to SICU
* Transfer to ICU from wards after surgery
Dysphagia and Quality of Life in Patients With Oral Squamous Cell Carcinoma Before and After Treatment

While the group of oral cavity cancer (OCC) survivors continue to increase, surgeons and oncologist intensify their search for improved treatment and rehabilitation methods to reduce the morbidity of management without compromising the oncological safety. The predominant problem after treatment of OCC is dysphagia, which is associated with malnutrition, aspiration pneumonia, hospital re-admission, and reduced quality of life (QoL) and survival.

In a pilot study, the investigators found that 45% of OCC patients reported significant eating disabilities two years after surgical treatment. However, the international literature is limited on the dysphagia and QoL of OCC survivors.

With an overall goal to improve the QoL and health status in patients treated for OCC, the present study aims to

1. systematically evaluate the swallowing function before and after treatment,
2. investigate the impact of swallowing function on QoL,
3. identify risk factors for dysphagia,
4. investigate if swallowing function is an independent factor for the number of ´days alive and out of hospital´
5. evaluate the rehabilitation offered to OCC patients in Danish municipalities and the effect on swallowing outcomes.

One hundred patients treated for OCC will be included prospectively during a 2-year period. Data on type and location of tumour, treatment modality, complications, patient weight, dietary intake, rehabilitation program, hospital admissions, recurrences, and survival will be collected. Questionnaires and Modified Barium Swallow Study (MBSS) will be performed before and 2 and 12 months after treatment.


Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed squamous cell carcinoma with any location in the oral cavity including recurrences. Patients will only be included once
* Treatment with curative intent (surgery and/or (chemo)radio therapy)

Exclusion Criteria:

* Allergy to barium contrast
* Pregnancy or breastfeeding
* Inability or unwillingness to complete questionnaires and undergo examinations