cyrilzakka/clinical-trials huggingface dataset:
TAP vs QL for Postoperative Analgesia After DIEP Free Flap Breast Reconstruction

The purpose of this study is to compare the efficacy of Transversus abdominus plane (TAP) block and Quadratus Lumborum (QL) block on the quality of recovery after breast reconstruction with deep inferior epigastric perforator (DIEP) flap.

Breast reconstruction after mastectomy has seen continued growth and popularity in recent years secondary to improved surgical techniques and improved patient awareness and understanding. While implant-based reconstruction remain the most popular option, autologous tissue transfer, reconstruction of the breast with a patient's own tissues, has emerged as the gold standard for breast reconstruction, most commonly performed with abdominally-based flaps, such as the deep inferior epigastric perforator (DIEP) flap.

Postoperative pain can be a difficult challenge in patients who have undergone DIEP flap. Patients with worse postoperative pain control report worse overall satisfaction with their surgical experience.

A multimodal analgesia protocol is a key component in the postoperative care after DIEP flap. Regional nerve blocks present an adjunct to these protocols that can potentially improve the quality of recovery of these patients.

Transversus abdominus plane (TAP) blocks have been shown to be a safe and effective technique to manage postoperative pain at the abdomen in this population; lowering usage of opiates, shortening length of stay and reducing episodes of nausea and vomiting. TAP's efficacy is well-established and documented for postoperative analgesia in abdominal surgery. This can be done preoperatively by an anesthetist via ultrasound-guidance or, using traditional technique of direct visualization, intraoperatively by the operating surgeon. Surgeon-performed intra-operative TAP block are often preferred as it is less time-consuming. TAP block has become the standard abdominal regional nerve block to perform during this procedure.

More recently, QL block has emerged as an alternative to TAP block for lower abdominal surgery. The QL block is an ultrasound-guided fascial plane block performed by an anesthetist for anterior abdominal wall analgesia.

This study will compare QL block to TAP block in patients undergoing DIEP free flap breast reconstruction.

Eligibility Criteria:
Inclusion Criteria:

* Women (age 18 years or older) who are booked for abdominally based free flap for breast reconstruction
* Patients with America Society of Anesthesiologists (ASA) physical status class I, II and III

Exclusion Criteria:

* Patients not consenting for regional block
* Patients allergic to local anesthetics and adjuvants
* Patients with America Society of Anesthesiologists (ASA) physical status class IV and V
* Patients with any baseline opiate consumption
* Presence of infection at needle insertion site
* Patients with coagulopathy (INR\>1.3)
* Patients with thrombocytopenia (Platelets\<100)
* Patients on therapeutic anticoagulation
Effect of Prosthetic Rehabilitation on Nutritional Status of Geriatric Patients

This study examines the effects of prosthetic treatment options applied to edentulous geriatric individuals who applied to Marmara University Faculty of Dentistry on chewing function, food consumption status, malnutrition status and oral health-related quality of life.


Eligibility Criteria:
Inclusion Criteria:

* ≥ 50 years old,
* Those who volunteer to participate in the study,
* Those who have adequate bone height and thickness in the intraforaminal region
* Those who have Upper and lower fully edentulous jaws

Exclusion Criteria:

* Those who have systemic diseases that may cause systemic neuropathy, such as diabetes, hypertension, kidney disease,
* Those who do not want to sign the consent form,
* Clinical or radiographic pathological condition in the intraforaminal region
* Patients with a history of malignancy, radiotherapy or chemotherapy will be excluded from the study.
Effects of Enriched Gardens in Nursing Home Residents With Dementia

Comparing the effect of the frequentation of an enriched garden vs sensory conventional garden by nursing home residents with Alzheimer disease. The effects will be evaluated as regards to cognitive impairment (MMSE), autonomy (ADL) and prevention of falls (Unipodal stance and UpandGo Test)

The cluster controlled trial is conducted over a six months period after recruitment of residents from 4 different nursing homes in France. The participants are distributed into 3 groups. One group does not receive incentive from carers to visit any garden, the second group receives incentives to visit regularly a conventional sensory garden and the third group receive incentives from carers to visit regularly an enriched garden. The study is conducted over a period of 6 months. All participants are giving consent to the study. They will be evaluated before and after over 4 different tests. MMSE (Mini Mental Status Examination) for cognitive impairment, ADL (Activity for day Living) for functional autonomy, TUG (Test up and Go) and Unipodal Stance for prevention of falls.

Eligibility Criteria:
Inclusion Criteria:

* Give consent
* Ability walking alone
* Alzheimer's disease

Exclusion Criteria:

* No dementia
* Severe dementia
* Severe behavioural disorder
* Inability to walk alone
DWI Breast MRI in Dense Breast: A Clinical Trial to Assess the Efficacy and Diagnostic Accuracy of Diffusion Weighted Imaging in Dense Breast Tissue

his clinical trial aims to evaluate the efficacy and diagnostic accuracy of Diffusion Weighted Imaging (DWI) in breast MRI for women with dense breast tissue. DWI is investigated as an adjunctive method to improve early tumor detection in women with dense breasts, a group at high risk for delayed diagnosis due to limited visibility in mammography.

Study Purpose:

To assess the utility of Diffusion Weighted Imaging (DWI) in improving diagnostic accuracy for patients with dense breasts.


Eligibility Criteria:
Inclusion Criteria:

* Women aged 40-75 years.
* Patients with dense breast tissue, classified according to BI-RADS (Breast Imaging-Reporting and Data System).
* Patients who previously underwent breast MRI, including Diffusion Weighted Imaging (DWI).
* Availability of histopathological confirmation for breast lesions (biopsy results).

Exclusion Criteria:

* Patients with a known allergy to gadolinium-based contrast agents.
* Pregnant or breastfeeding women at the time of imaging.
* Presence of metallic implants or other MRI-incompatible devices.
* Patients with incomplete imaging datasets (e.g., missing DWI sequences or non-standardized protocols).
* Prior history of breast cancer treatment (surgery, chemotherapy, or radiotherapy) before the imaging study.
National Data Bank for Rheumatic Disease Registry Study of Safety in Patients With Rheumatoid Arthritis Treated With Cimzia® or Disease-modifying Antirheumatic Drugs (DMARDs)

Observational registry to assess the longer-term risk of serious infections and malignancies reported with TNFα-blocker therapy, as well as the longer-term risk of cardiovascular and thromboembolic events in adult Rheumatoid Arthritis (RA) patients treated with Cimzia® as compared to non-biologic DMARD-treated controls.


Eligibility Criteria:
Inclusion Criteria:

* RA and started treatment with certolizumab pegol (Cimzia®; CZP) or non-biologic DMARD within the last 6 months
Human Papillomavirus Education Programs

This clinical trial aims to implement a culturally-tailored educational outreach actives with the goal of increasing knowledge of human papillomavirus (HPV) types that can lead to cancer and uptake of the available vaccine. The initiative also addresses barriers to vaccination and refer people to sites where they can get the HPV vaccine (e.g., private doctor offices, community health clinics, school-based health centers, and health departments). The HPV education program may help increase HPV vaccination rates and ultimately prevent HPV-related cancers.

PRIMARY OBJECTIVE:

I. To implement culturally tailored educational outreach activities with the goal of increasing knowledge of HPV types that can lead to cancer and uptake of the available vaccine.

OUTLINE:

Participants attend educational session about HPV-related cancers, screening, and HPV vaccination and guidelines and receive informational infographic handout on HPV vaccination. Participants also complete surveys pre and post education session over 5 minutes each to assess HPV vaccination status among children of participants, HPV knowledge, and intentions to get the HPV vaccination, and screening among participants. Participants participate in surveys over telephone or face-to-face at 3 and 6 months.

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age and older
* From Ohio
Effects of LEDs on Memory in TBI Patients

The purpose of the study is to investigate whether transcranial, high-intensity LED placed on the scalp can improve working memory in people who have sustained a concussion with lingering effects or a mild brain injury.

This is a four month, outpatient, single center study investigating whether transcranial, high intensity LED applied outside the skull can improve frontal lobe executive function and working memory in participants with chronic, mild Traumatic Brain Injury (TBI), with or without mild posttraumatic stress disorder (PTSD), due to closed head injury.

Participants will sign the Informed Consent Form(ICF) before Neuropsychological Screening test are administered. If the participant's neuropsychological screening test scores meet the Inclusion/Exclusion criteria and the participant meets the other Inclusion/Exclusion criteria, then he/she will be tested again on the tests that are part of the Neuropsychological Outcome Measures, the week before the Transcranial LED treatments, and during the week after the last LED treatment and again at one and two months after the last LED treatment. Treatment with Transcranial LED will be for 6 weeks. Participants will be treated three times per week: Monday, Wednesday and Friday. A total of 18 Transcranial LED treatments will be administered.

Eligibility Criteria:
Inclusion Criteria:

* Male or female, Ages 18-65
* sustained a mild traumatic brain injury(mTBI) at least 6 months ago
* mTBI is defined as \< 30 minutes loss of consciousness and \<30 minutes, post trauma amnesia
* since the injury patient continues having problems with memory and thinking ability

Exclusion Criteria:

* Younger than 18 or older than 65
* mTBI occured less than 6 months ago
* moderate to severe Traumatic Brain Injury (TBI)
* non-closed head injury
* presence of craniotomy, craniectomy, or ventriculoperitoneal shunt
* Non-English speaking subjects - Neuropsychological Tests only in English
* Neuropsychological Screening Test Scores not at least 2 SD below norm on one of the neuropsychological tests or not 1 SD below norm on at least two of the tests administered during screening)
Expanded Indications in the Adult Cochlear Implant Population

The purpose of this investigation is to expand FDA-approved labeling for MED-EL cochlear implants to include adults who have moderate to profound sensorineural hearing loss and obtain limited benefit from appropriately fit hearing aids.

Fifty (50) subjects, 18 years of age and older, will be implanted across the United States and Canada. Subjects with moderate to profound bilateral sensorineural hearing loss will be implanted with the MED-EL SYNCHRONY/SYNCHRONY PIN Cochlear Implant System. .

Limited benefit from amplification is defined by test scores of 60% correct or less in the ear to be implanted (70% or less in the nonimplanted ear) on monosyllabic words in quiet. Subjects will be followed for twelve (12) months post-activation of the SONNETEAS Audio Processor.

Eligibility Criteria:
Inclusion Criteria:

* Adults, 18 years of age or older at the time of implantation
* Moderate to profound hearing loss in the low frequencies and severe to profound hearing loss in the high frequencies, bilaterally as defined by: Low-frequency PTA (250, 500, and 1000 Hz) greater than 40 dB High-frequencies not better than 65 dB (3000 Hz - 8000 Hz)
* Sensorineural hearing loss, demonstrated by an air-bone gap of less than or equal to 10dB
* Limited benefit from appropriately fit hearing aids, defined by CNC word score in quiet of 60% or less in the ear to be implanted and 70% or less in the non-implanted ear
* CNC word score in quiet of greater than or equal to 10% in the ear to be implanted
* Evidence of appropriately fit hearing aids as determined by the audiologist
* Bilateral hearing aids should be considered standard of care, except in situations where the audiologist, physician, or potential subject determines that unilateral fit is optimal
* Hearing aid fit should be verified through accepted measures such as functional gain or real-ear verification
* If appropriately fit hearing aids have not been worn within the last year, a 30-day hearing aid trial must be completed prior to enrollment in the study
* Fluent in English
* No radiological contraindications
* Ability to undergo general anesthesia
* Appropriate motivation and expectation levels
* Stated willingness to comply with all study procedures for the duration of the study

Exclusion Criteria:

* Evidence that hearing loss is retrocochlear in origin
* Active middle ear infection
* Skin or scalp condition precluding use of external audio processor- Suspected cognitive impairment or organic brain dysfunction
* History of prior use of a hearing implant
A Study on the Safety and Effectiveness of Adefovir Dipivoxil in Combination With Anti-HIV Therapy (HAART) in HIV-Positive Patients

The purpose of this study is to see if it is safe and effective to give an experimental anti-HIV drug, adefovir dipivoxil (ADV), in combination with other anti-HIV drugs (HAART) to patients who have a viral load (level of HIV in the blood) between 50 and 400 copies/ml.

Patients are randomized to 1 of 2 arms in a 2:1 ratio. Approximately 260 patients receive ADV and approximately 130 patients receive placebo. Patients receive ADV or placebo in addition to L-carnitine and their current stable HAART regimen. Each patient receives blinded study medication for 48 weeks and is evaluated at Weeks 16, 24, and 48. Patients who reach the primary endpoint of virologic failure prior to Week 48 may continue blinded study medication or receive open-label ADV at the investigator's discretion. In both cases, patients continue their study visits as per the original visit schedule. Virologic failure is defined as 2 consecutive HIV-1 RNA measurements, after baseline, above 400 copies/ml (measured by the Roche Amplicor HIV-1 Monitor UltraSensitive assay) drawn at least 14 days apart. All patients who complete study visits without treatment-limiting ADV toxicity may continue open-label ADV in the Maintenance Phase at the discretion of the principal investigator.

Eligibility Criteria:
Inclusion Criteria

You may be eligible for this study if you:

* Are HIV-positive.
* Have been on a stable HAART regimen consisting of at least 3 antiretroviral drugs for at least 16 weeks prior to study entry.
* Have a CD4 count of 50 cells/mm3 or more.
* Have a viral load greater than 50 and less than or equal to 400 copies/ml within 14 days prior to study entry.
* Have had at least 1 additional viral load in the past that was less than or equal to 400 copies/ml while on your current stable HAART regimen.
Impact of Clinical Pharmacy Services on Medication Cost and Hospitalization Rates in Hemodialysis Patients

The purpose of this study is to evaluate the effects of pharmaceutical care interventions in the ambulatory hemodialysis patients over a one-year period. Cost containment occurs through pharmaceutical care interventions designed to identify and ameliorate drug-related problems (DRPs), improve the cost-effectiveness of therapeutic regimens and prevent hospitalizations.

Approximately 350,000 end-stage renal disease (ESRD) patients in the United States utilized over $17.9 billion Medicare dollars in 1999. The ESRD population and cost is projected to double by 2010. ESRD patients have a mean of 5 comorbidities per patient and are prescribed a median of eight medications. The average monthly medication cost per patient is approximately $1,200.00. For every dollar spent on medication an additional $1.77 is spent on drug-related problems (DRPs). Dialysis patients are at high risk for DRPs. It is unknown if continued pharmacist intervention in hemodialysis patients will improve patient care, reduce medication utilization and cost, and prevent hospitalization as seen in other populations. The purpose of this study is to investigate the impact of continued pharmacist intervention in ambulatory hemodialysis patients.

Eligibility Criteria:
Inclusion Criteria:

* Patients are eligible for inclusion in the study if they have been on HD for greater than three months, greater than 18 years of age, those who plan to be continuously enrollment in therapy at the same dialysis center throughout the duration of the study. Informed consent will be obtained on eligible patients. The study is to be approved by the Human Research Review Committee prior to initiation.

Exclusion Criteria:

* Patients will be excluded if they have been on HD for less than three months, decline the opportunity to participate, or are less than 18 years of age.
Preanesthetic Analgesia/Nociception Index (ANI) and Propofol Injection Pain

Recently, Analgesia Nociception Index (ANI) has been evaluated for objectively measuring peri-operative pain and to guide intra-operative opioid administration during various surgeries.

Propofol injection pain (PIP) is a common problem and can be very distressing to the patient.

This study aimed to the association of preanesthetic ANI scores and PIP in patients who scheduled for general anesthesia.

Before propofol administration in remifentanil group, preanesthetic ANI values (instant and mean) were checked after remifentanil to a target Ce of 4 ng/ml.

Control group received the same volume of saline as remifentanil group. Heart rate and bispectral index were checked as ANI. Point biserial correlation and ROC curve were analyzed.

Eligibility Criteria:
Inclusion Criteria:

* Male patients who scheduled for general anesthesia
* Cognitive patients who could understand this study

Exclusion Criteria:

* Patients receiving β-receptor blockers, ketamine, clonidine, or any vasoactive substance (i.e. metaraminol, ephedrine) and patients receiving neostigmine, atropine or glycopyrrolate.
Paclitaxel and Capecitabine in Patients With Metastatic/Recurrence Esophageal Cancer

Capecitabine is an orally administered fluoropyrimidine that is converted by 5-FU by thymidine phosphorylase (TP), preferentially in tumor tissues and has demonstrated activity as single agent in patients with gastrointestinal cancer. Up-regulation of TP after taxane treatment in vitro suggested that there may be synergistic effects in combined treatment with taxane and capecitabine. The combination of taxane and capecitabine was reported to be highly active against non-small cell lung cancer, breast cancer, and stomach cancer.

Paclitaxel-80 mg/m2/IV D1 \& D8 q 3 weeks Capecitabine-900 mg/m2/PO twice daily Days 1-14 q 3 weeks

Patients receive treatment every 3 weeks till disease progression.

Eligibility Criteria:
Inclusion Criteria:

1. Histologically or cytologically confirmed esophageal cancer with histology of squamous carcinoma or adenocarcinoma
2. Clinically diagnosed metastatic or recurrent esophageal cancer according to Sixth Edition of the AJCC Cancer Staging Manual (Appendix V)
3. At least 18 years old
4. Disease status must be that of measurable disease defined as RECIST:Lesions that can be accurately measured in at least one dimension \> 10 mm with chest x-ray, spiral CT scan or physical examination
5. ECOG performance status 0-2
6. No prior radiotherapy to measurable lesion(s) but previous surgery and/or chest radiotherapy for the primary lesion is allowed
7. Adequate major organ function including the following:Hematologic function: WBC ≥ 3,500/mm3 or absolute neutrophil count (ANC) ≥ 1,500/mm3, platelet count ≥ 100,000/mm3Hepatic function: bilirubin ≤ 1.5 x UNL , AST/ALT levels ≤ 2.5 x UNLRenal function: serum creatinine ≤ 1.5mg/dL
8. Patients should sign an informed consent
9. If female: childbearing potential either terminated by surgery, radiation, or menopause, or attenuated by use of an approved contraceptive method (intrauterine device \[IUD\], birth control pills, or barrier device) during and for 3 months after trial. If male, use of an approved contraceptive method during the study and 3 months afterwards. Females with childbearing potential must have a urine negative hCG test within 7 days prior to the study enrollment.

Exclusion Criteria:

1. MI within preceding 6 months or symptomatic heart disease including unstable angina, congestive heart failure, or uncontrolled arrhythmia
2. Serious concurrent infection or nonmalignant illness that is uncontrolled or whose control may be jeopardized by complication of study therapy
3. Pregnant or nursing women
4. Other malignancy with the past 5 years except adequately treated cutaneous basal cell carcinoma or uterine cervix in situ cancer
5. Psychiatric disorder that would preclude compliance.
6. Major surgery other than biopsy within the past two weeks
Efficacy and Safety of Recombinant Asparaginase in Infants With Previously Untreated Acute Lymphoid Leukemia (ALL)

This non-controlled multicentre phase II study is designed to assess the safety and to describe (in relation to children of higher age) the pharmacodynamics of recombinant ASNase (rASNase) for first-line treatment of infants (\< 1 year of age at diagnosis) with de novo acute lymphoblastic leukaemia


Eligibility Criteria:
Inclusion Criteria:

* Previously untreated T-lineage or precursor B-lineage ALL or biphenotypic leukaemia according to EGIL criteria.
* Morphological verification of the diagnosis, confirmed with cyto¬chemistry and immunophenotyping.
* Age \< 1 year at diagnosis.
* Written informed consent of the parents or other legally authorised guardian of the patient.
* Treatment according to protocol INTERFANT 06

Exclusion Criteria:

* Mature B-lineage ALL, defined by the immunophenotypical presence of surface immunoglobulins or t(8;14) and breakpoint as in B-ALL.
* The presence of the t(9;22)(q34;q11) or bcr-abl fusion in the leukaemic cells.
* Systemic use of corticosteroids less than 4 weeks before diagnosis. Patients who received corticosteroids by aerosol are eligible.
* Known allergy to any ASNase preparation.
* Pre-existing known coagulopathy (e.g. haemophilia).
* Pre-existing pancreatitis.
* Liver insufficiency (bilirubin \> 50 µmol/L; SGOT/SGPT \> 10 x the upper limit of normal).
Long-term Cognitive, Neuropsychiatric and Functional Outcomes in Adults Who Have Received Chimeric Antigen-Receptor T-Cell (CAR-T) Therapy for Aggressive Lymphoma at Stanford

This study aims to assess the feasibility of performing neuropsychological testing to measure the cognitive performance of individuals following Axicabtagene ciloleucel CAR-T therapy at Stanford.


Eligibility Criteria:
Inclusion Criteria:

* \>/= 18 years-old
* Treated with Axicabtagene ciloleucel CAR-T therapy at Stanford Or
* Treated with standard commercial Axicabtagene ciloleucel CAR-T therapy elsewhere and followed primarily by SHC Blood and Bone Marrow transplant providers
* \>/= 6 months from the date of CAR-T infusion
* Fluent in English
* Able to attend and participate in in-person testing (Arm I)
* Able to participate in remote video testing with adequate workspace, computer and internet capabilities for a reliable telehealth video connection (Arm II)

Exclusion Criteria:

* Concurrent enrollment in a CAR-T therapeutics research study
* Unable to be present for the scheduled testing
* Unable to participate in testing due to severe cognitive or physical limitation
* Actively receiving chemotherapy
* Progressive cancer