cyrilzakka/clinical-trials huggingface dataset:
Quality of Life Following Gastric Bypass Surgery.

A central goal of health care is to maximize patient functioning and well-being. This has prompted measurement of health-related quality of life (HRQOL) that encompasses physical, psychological, and social functioning. While obese people have generally impaired HRQOL, people seeking bariatric surgery for obesity appear to have poorer HRQOL than obese individuals seeking non-surgical treatment or obese individuals not seeking weight-loss treatment. HRQOL improves significantly after bariatric surgery, but often with large individual variations in outcome. As gastric bypass is an invasive procedure with irreversible influences on eating behaviour and possible serious adverse events, it is important to identify potential risk factors for a poorer long-term result. In Denmark, bariatric surgery is free of charge for patients fulfilling the Danish Health and Medicines Authority guidelines, which until 2011 were in line with international guidelines. However, in 2011 access to surgery was dramatically restricted and the annual number of operations reduced from 0.9 per 1000 inhabitants (2010) to 0.2 per 1000 inhabitants (2012). The restrictions involved a tightening of the criteria for patients without manifest obesity comorbidities, raising lower body mass index (BMI) threshold from 40 to 50 and increasing the lower age limit from 18 to 25 years (11). It is not known whether patients fulfilling the tighter criteria benefit more from surgery than patients who only met the previous criteria.

This study assessed HRQOL changes associated with Roux-en-Y gastric bypass with follow-up over an average of 22 months. The aim was to explore whether postoperative HRQOL variations were associated with identifiable socio-demographic or clinical characteristics. In particular, whether HRQOL changes differed for patients fulfilling the current Danish criteria and patients only fulfilling the previous criteria.


Eligibility Criteria:
Inclusion Criteria:

* Patients referred for gastric bypass.

Exclusion Criteria:

* Patients who did not fulfill the national criteria.
Cognitive Detection of Preclinical AD: Validation Using Biomarkers

The current study aims to validate several novel cognitive tasks expected to be sensitive to brain impairment in specific anatomic regions affected in preclinical Alzheimer's disease(pAD). The tasks are validated in 60 cognitively and clinically normal participants ages 60 - 85, inclusive, against reasonably well-established biomarkers of Alzheimer's disease, including 1) simultaneous positron emission tomography (PET) \[18F\]Flutemetamol amyloid and CT imaging and 2) to the extent data is available from other studies, participants' brain MRI and cerebral spinal fluid (CSF) amyloid and tau.

Biomarkers, such as amyloid deposition, and Hipp volume loss, and low Aβ and high pTau in CSF, are useful for identifying cognitively normal (CN) elderly who are likely have early AD pathology ("preclinical AD"). However, they are invasive and/or expensive. The goal of the current study is to develop and validate cognitive proxies of AD biomarkers by using cognitive tasks that are dependent on brain regions impaired by very early AD pathology. If successful, these tasks will provide a non-invasive and cost-effective way to identify and track change in CN individuals at high risk for progressing to mild cognitive impairment (MCI) and dementia stages of AD and thus will facilitate future prevention trials in pAD.

Subjects will attend three study visits. During the first study visit, subjects will have eligibility criteria confirmed, have a blood sample drawn, and complete about half of the cognitive tasks. The second visit, which will occur within one week of visit one, will involve completion of the remaining cognitive tasks. Subjects will also be asked to have a PET-CT scan during visit three (to occur within 3 months of visits 1 and 2).

Eligibility Criteria:
Inclusion Criteria:

* Prior enrollment as a participant in the NYU Alzheimer's Disease Center (ADC) and completion of the ADC Clinical Evaluation within the past year.
* Clinical diagnosis of "cognitively normal" or "amnestic mild cognitive impairment" based on recent (within 1 year) consensus meeting cross-referenced with standard neuropsychological scores.
* Normal or corrected-to-normal vision and hearing (able to see images on computer screen and hear auditory events delivered through the computer speaker).

Exclusion Criteria:

* Significant history of mental illness, drug or alcohol abuse; severe trauma preventing normal use of dominant hand (needed to move the mouse cursor); clinical depression (unless medically controlled); other neurologic conditions (i.e. stroke), or learning disability; ophthalmologic/visual problems that prevent viewing a computer screen at a normal distance (such as legal blindness, detached retinas, occlusive cataracts).
* Lack of capacity to give informed consent and no legally authorized representative to provide consent.
* Having pacemakers, aneurysm clips, cochlear implants, or metal/foreign objects in body and therefore, unable to receive MRI.
* Pregnancy, breastfeeding or planning to have a baby.
Observatory on Cow's Milk Protein Allergy

The purpose of this study is to describe the symptoms and their evolution up to the age of 5 years in a population of newly diagnosed infants with a suspected or confirmed allergy to cow proteins, for whom the doctor prescribed the Pepticate® Syneo® replacement formula as soon as they were diagnosed.

The Pepticate® Syneo® product is an advanced protein hydrolyzate, food type intended for special medical purposes. This is a product already available on the market.

This is a prospective, observational, descriptive, longitudinal, multicentric study aimed at describing a cohort of infants with a recently suspected or confirmed allergy to cow's milk protein, who were treated in outpatient and inpatient settings.

The recruitment of patients eligible for this observatory will be done via community medicine (private practices of pediatricians and general practitioners) as well as in hospitals throughout France.

Eligibility Criteria:
Inclusion Criteria:

* Infants up to and including 8 months (up to 8 months and 29 days).
* Initial diagnosis of allergy to cow proteins, suspected (clinical presumption) or confirmed.
* Prescription of the substitution formula Pepticate® Syneo, according to the doctor's judgement, whether the child is under mixed or weaned breastfeeding.
* Authorisation from a legal representative for the child to take part in the observatory and to collect personal information about the child and the family.
* Membership of the social security system.

Exclusion Criteria:

* Infants who have already received partial or total replacement infant formula (regardless of the type of infant formula).
* Contraindication to the use of symbiotics (short small intestine, parenteral nutrition, post-pyloric feeding, central venous catheter) due to the use of Pepticate® Syneo®.
* Diagnosis of severe cow protein allergy requiring an infant amino acid formula from the outset.
* The child's legal guardian is protected (under legal protection, or deprived of liberty by judicial or administrative decision).
* The legal representative is unable to understand the study protocol.
Assessment of Pain When Removing Metallic Brackets for Orthodontic Patients Using Two Removal Methods

Patients at the Orthodontic Department of the University of Damascus Dental School will be examined, and subjects who meet the inclusion criteria will be included. Then after finishing the orthodontic treatment, Patients were randomly assigned into two groups:

Open mouth group:

The debonding procedure was conducted using the open-mouth technique. All brackets were removed using a Weingart plier (American Orthodontics, Sheboygan, Wisc) by squeezing them from both sides of the mesial-distal surfaces. Before debonding, the stainless steel finishing archwires (0.017 × 0.025 inches) were removed.

Biting-on a-cotton-roll-group:

All brackets were removed using the same plier. The brackets were debonded using a Weingart plier (American Orthodontics, Sheboygan, Wisc) by squeezing them from both sides of the mesial-distal surfaces. Additionally, cotton rolls were placed between the upper and lower teeth, and patients were instructed to bite on them during the procedure. Before debonding, the stainless steel finishing archwires (0.017 × 0.025 inches) were removed. Patients in the second group were instructed to bite on a cotton roll throughout the debonding process.

Pain is a subjective experience that can vary widely among individuals. It is influenced by several factors, including age, gender, personal pain threshold, psychological and social conditions, past negative experiences, and the degree of force applied.

Although various methods for bracket debonding, such as ultrasonic instrumentation, lasers, and electro-thermal debonding, are documented in the literature, hand tools like Weingart pliers remain among the most practical solutions. This study focused on using Weingart pliers to compare the pain scores in two techniques-open mouth and biting on a cotton roll-during bracket removal. These methods are widely used in orthodontic clinics and are readily available to orthodontists.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged 16 to 25 years,
* Undergoing orthodontic treatment with MBT prescription 0.022-inch metal brackets with a single-mesh base (Pinnacle®, MBT compatible 0.022, OrthoTechnology™, Florida, USA) who were in the final stage of their treatment and planned for debonding,
* The brackets bonded with the same bonding cement (Ivoclar Heliosit Orthodontic Adhesive Composite) and the same primer (Ivoclar Vivadent Tetric N-Bond),
* Absence of debonded brackets at the debonding process,
* The 0.017 × 0.025-inch stainless steel finishing archwires in their places for at least one month,
* Good occlusal relationships and strong intercuspation,
* No recent use of medications such as painkillers or corticosteroids in the last day,
* Absence of acute or chronic dental pain induced by periodontal/periapical lesions or caries,
* There is an absence of a history of surgical treatment, including impacted tooth eruption, tooth transplantation, or the presence of mini-screws.

Exclusion Criteria:

* Presence of any craniofacial syndromes or systemic diseases
* Previous facial trauma
* Previous orthodontic treatment
Study of the Usefulness of the Probiotic 'Lactobacillus Reuteri' in the Therapy of Quadruple Eradication of Helicobacter Pylori Infection in Usual Clinical Practice.

Helicobacter pylori is a Gram-negative bacterium with a helical bacillus shape that it's able to penetrate and colonize the stomach mucosal lining by infecting it.

The eradication treatment of H. pylori is supported by numerous consensus groups worldwide and it is generally safe and well tolerated. Standard treatment is based on multiple drug regimens. However, its effectiveness has been increasingly compromised due to the emergence of resistant strains, as well as poor adherence to treatment. Therefore, it's proposed a randomized, double-blind, placebo-controlled study whose aims are:

1. Determine whether the combination of two probiotic strains of L reuteri (Gastrus) will improve gastrointestinal symptoms when associated with four-way therapy (of any type).
2. Prove whether supplementation with Gastrus (food supplement) versus Placebo is able to reduce the gastrointestinal adverse effects of quadruple eradication therapy.

They will be determined by the GSRS gastrointestinal symptom scale in routine clinical practice.


Eligibility Criteria:
Inclusion Criteria:

* Patients attended at the clinic visit who present a positive diagnosis of H pylori infection using different diagnostic techniques (C13 breath test, histology, urease and / or H pylori antigen in stools).
* Age between 18 and 65 years

Exclusion Criteria:

* Patients taking other probiotics 4 weeks prior to study start.
* Patients who have previously received eradicating therapy.
* Patients who are treated with NSAIDs, aspirin or other anti-inflammatory drugs either on an occasional basis (one week prior to the study) or on a chronic basis (3 weeks prior to inclusion).
* Patients who have used oral antibiotics two weeks prior to inclusion.
* Pregnancy
Bile Duct Injury Digestif

Data accumulated from medical record collected from January 2008 until December 2018


Eligibility Criteria:
Inclusion Criteria:

* adult patients with extrahepatic bile duct injury managed by digestive division of Cipto Mangunkusumo hospital

Exclusion Criteria:

* none
Observational Pilot Study With TachoSil as a Ventricular Sealant

The working hypothesis in this study is that after entering the cerebral ventricular system the sealing with TachoSil is effective and safe.

A more specific hypothesis is that the use of Tachosil for brain surgery with ventricular entry reduces the number of postoperative complications (hydrocephalus, CSF leak, meningitis and pseudomeningocele).

Pilot observational study with medications (MOE), single-center, prospective and retrospective study with a group of patients operated on for periventricular lesions and with ventricular entry. As it is an infrequent type of surgery in our centre, the study includes a retrospective group (same surgery and use of TachoSil).

Primary objectives:

The main objective of the study is to evaluate the effectiveness and safety of TachoSil in patients who require ventricular entry.

To evaluate the effectiveness, the percentage of complications related to the ventricular entry during surgery are recorded. These complications are hydrocephalus, CSF leak, meningitis, and pseudomeningocele.

Secondary objectives

* Intraoperative incidence of fistula after application of the ventricular patch at 20cm PEEP H20 (efficacy objective).
* Incidence of clinically confirmed percutaneous fistula during the first 30 days after surgery (efficacy objective).
* Incidence of pseudomeningocele \>20cc confirmed with MRI or ultrasound (effectiveness objective).
* Incidence of radiologically confirmed hydrocephalus during the first 90 days after of the surgery.
* Record the percentage of use of other dural sealants
* Evaluate the cost effectiveness of the product.
* Describe the adverse effects related to the product
* Incidence of complication requiring reintervention within 30 days to the main surgery (safety objective).
* Assessment of the complications that are avoided: readmissions.

Study period: from December 2020 to December 2023.

Eligibility Criteria:
Inclusion Criteria:

* Patients who are candidates for elective supratentorial surgery (tumoral, vascular or epilepsy) that during the procedure present ventricular entry, being sealed by a patch of TachoSil
* Ventricular entry during the procedure (intraoperative CSF outflow from the ventricle noticed by the surgeon)
* Adults over the age of 18
* Informed consent signed by the patient or representative (see annex 2). For cases in which the patient has died during this time a waiver of consent will be requested.

Exclusion Criteria:

* Patients or representatives who do not want to sign the consent are excluded informed, pregnant women or those under 18 years of age.
Xience V at Wake Forest University Baptist Medical Center (WFUBMC)

The effectiveness, safety, and deliverability of second generation drug eluting stents (DES), including Xience V, will need to be examined in real world patients to provide the same level of evidence base and comfort that has accompanied the use of the first generation devices. Randomized clinical trials provide the fairest evaluation of outcomes by controlling for confounding patient and procedural characteristics; however, randomized clinical trials also exclude the very high risk patients that account for upwards of 80% of real world patient populations such as those at Wake Forest University Baptist Medical Center (WFUBMC).

Clinical follow-up data including non-fatal MI, all cause mortality and stent thrombosis, as well as medications compliance, of patients undergoing stent therapy including Xience V in a real world patient population will be collected at WFUBMC. Existing data for several control groups will be used to compare outcomes with Xience V including a consecutively treated bare metal stent (BMS) cohort of 1,200 patients, and a DES cohort of 1,200 patients (900 sirolimus-eluting and 300 paclitaxel-eluting) treated between April 2004 and April 2005. Patients undergoing stent therapy in the year prior to use of Xience V, and contemporaneous patients receiving non-Xience V stent therapy during Xience V use will serve as additional controls. All patient data will be de-identified using unique blinded identification codes after data collection is completed.

The null hypothesis of this study states that safety outcomes (stent thrombosis, non-fatal MI, death) with Xience V will be equivalent to historical and contemporaneous controls; effectiveness outcomes (target lesion and target vessel revascularization) with Xience V will be superior to historical and contemporaneous BMS controls, and equivalent to historical and contemporaneous DES controls; and the need for crossover to another stent type will be equal to that observed with historical DES controls. Outcomes will be reported using contemporary measures of clinical outcomes and analyzed using Cox proportional hazards survival analysis methodology. These data should provide important information on the clinical effectiveness and safety of Xience V in routine practice.


Eligibility Criteria:
Inclusion Criteria:

* percutaneous coronary intervention with stenting

Exclusion Criteria:

* none
Cell Mediated Immunity and the Prediction of CMV Infection In Solid Organ Transplant Recipients

Cytomegalovirus (CMV) is a common cause of illness in patients who have undergone a transplant. Serious infections due to CMV can affect many parts of the body including the lungs, the gut, and the liver. Since transplant recipients are at risk for CMV or have evidence of infection with CMV, they are given an antiviral drug (usually ganciclovir or valganciclovir). Despite this, there are a chance that CMV infection may cause problems in the future. The purpose of this study is to assess how well patients'immune systems responds to the CMV virus, so that in the future it may be possible to predict which patients are at highest risk of CMV.


Eligibility Criteria:
Inclusion Criteria:

* Male or female patients who fulfill the following criteria are eligible for inclusion.

  * CMV D+/R- liver, kidney and heart recipient
  * CMV R+ liver,kidney and heart recipients who have received thymoglobulin induction therapy.
  * D+/R- and R+ lung transplant recipients.
  * Able to give written informed consent
  * Are willing and able to comply with the protocol
  * Age \>=18 years

Exclusion Criteria:

* Patient unwilling or unable to give informed consent
International Validation Study of Sentinel Node Biopsy in Early Cervical Cancer

SENTICOL III is large prospective multicenter international randomized study designed to validate the Sentinel Lymph Node (SLN) mapping technique in early cervical cancer. This "validation study" will compare the outcome of patients with negative SLN (experimental arm) vs patients with negative SLN + Pelvic Lymph Node dissection (PLN)(reference arm).

There will be a "quality assurance" program which will be developed in participating centers with detailed requirements in terms of surgeons' qualifications, pathology qualification, SLN ultrastaging, standardization of the procedure, etc. as well as respect of the "safety algorithm".


Eligibility Criteria:
Inclusion Criteria:

I 1. Patient must be ≥ 18 years old, I 2. With squamous or adenocarcinoma or adenosquamous carcinoma of the cervix (proven by biopsy or cone biopsy), I 3. Stage Ia1 with lymphovascular emboli, Ia2, Ib1 IIa1, Ib2 (clinical stage) of the 2018 FIGO classification (see appendix 1), I 4. Maximum diameter ≤ 40 mm by clinical examination and/or magnetic resonance imaging (MRI), I 5. No suspicious node on pelvic MRI with an exploration up to the left renal vein (according to RECIST 1.1), I 6. ECOG performance status 0-2 (see appendix 2), I 7. Signed informed consent and ability to comply with follow-up, I 8. French subjects: in France, a subject will be eligible for inclusion in this study only if either affiliated to, or a beneficiary of, a social security category.

Exclusion Criteria:

E 1. Pregnancy, E 2. Previous pelvic or abdominal cancer, E 3. Previous chemotherapy and/or radiation therapy for the cervical cancer (previous brachytherapy is accepted), E 4. Proven allergy to blue dye, isotope or indocyanine green (ICG) E 5. Other malignancy within the last 5 years except for treated cancer free of disease and treatment, E 6. Patients with synchronous cancer
Imatinib for Cytomegalovirus Prophylaxis and Treatment After Allogeneic Hematopoietic Stem Cell Transplantation

This study aim at examining whether blocking platelet-derived growth factor receptor-α by imatinib lowers the risk of post-allogeneic hematopoietic stem cell transplantation CMV infection.

This is a randomized, double-blind, multicenter phase II clinical trial. In the trial, post-allo-HSCT patients with signs of bone marrow engraftment and without evidence of CMV reactivation will be enrolled. All enrolled patients will be monitored for their blood CMV DNA copy numbers by Q-PCR and safety throughout the trial. In addition to their routine post-allo-HSCT care, eligible patients will receive imatinib (100mg/tablet, 2 tablets daily) or placebo (2 tablets daily) administration after myeloid engraftment (defined as absolute neutrophil count higher than 500 for three consecutive days). While receiving the trial therapy, patients will have a regular CMV surveillance every week by the quantification of plasma CMV DNA copies. During the administration of the investigational drugs, other concomitant anti-CMV prophylaxis treatments are prohibited. When a patient has any signs suggesting CMV infection that the treating physician determines that an anti-CMV therapy is indicated, the patient will be defined as failure of prophylaxis for the efficacy evaluation. Whether the conventional anti-CMV therapy is started or not, the investigational drugs with imatinib or placebo will be continued till at least Day+100 unless the patient is defined as prophylaxis failure or withdraws from the study including personal reasons, early mortality, disease recurrence after transplantation, pregnancy, or the investigator decides that the subject should be withdrawn for safety reasons or physical conditions.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients (Age ≧ 20) who received the first allo-HSCT are eligible;
* Patients with underlying disease of acute leukemia in morphological remission, or myelodysplastic syndrome;
* Received allo-HSCT with HLA-matched sibling or unrelated donors (at least 8/8 match for HLA-A/B/C/DR);
* Evidence of post-transplantation neutrophil engraftment: absolute neutrophil count \> 500/mm3 for at least 3 consecutive days;
* No detectable CMV infection before study enrollment: negative plasma CMV DNA surveillance within passing 2 weeks;
* No previous post-transplantation anti-CMV therapy and no planned prophylactic anti-CMV therapy;
* The patients has the ability to swallow tablets

Exclusion Criteria:

* They have renal insufficiency: serum creatinine \> 2.5 mg/dL;
* They have hepatic dysfunction: serum alanine or aspartate aminotransferase levels of \> 5 times the upper limit of the normal range or a serum total bilirubin of \> 3 mg/dL;
* Patients with history of HIV infection;
* Unstable post-BMT condition or other medical condition deemed not appropriate to be included to this study as judged by investigator;
* Life expectancy less than 3 months;
* Unwillingness or unable to give consent;
* Patients with diseases that are positive for t(9;22) or BCR-ABL fusion gene.