cyrilzakka/clinical-trials huggingface dataset:
Zoledronic Acid to Prevent Bone Loss After Kidney Transplantation

The purpose of this study is to determine whether zolendronic acid, a third generation bisphosphonate, is effective in preventing bone loss in the first year after kidney transplantation.

For the treatment of osteoporosis in the general population, a number of drugs reduce BMD (bone mineral density) loss and the rate of incident fractures. For instance, bisphosphonates improve BMD, reduce hip fracture rates and decrease mortality in post-menopausal women. Because of lack of data on safety and an increased risk of adverse effects, the use of these drugs is controversial in patients with chronic kidney disease (CKD) and abnormalities of PTH or vitamin D, an estimated glomerular filtration rate (GFR) less than 30 ml/min/1.73m² (CKD stages 4 and 5) and after transplantation. The efficacy of short and long term bisphosphonate treatment after kidney transplantation has been examined; however, histomorphometric and fracture rate reduction data are lacking.

The purpose of this study is to determine whether zolendronic acid, a third generation bisphosphonate, is effective in preventing bone loss in the first year after kidney transplantation.

Eligibility Criteria:
Inclusion Criteria:

* All adult kidney transplant recipients who were stable perioperative and able to return for regular follow-up

Exclusion Criteria:

* Glomerular filtration rate \< 30 ml/min/1.73m² one week after transplantation
* Previous parathyroidectomy or diagnosis of adynamic bone disease (with bone biopsy)
Balloon Eustachian Tuboplasty in Treatment of Chronic Eustachian Tube Dysfunction

The prevalence of Eustachian tube (ET) dysfunction in adults reaches 1%. It causes a feeling of fullness in the ear, otalgia and hearing loss and can lead to recurrent acute otitis media, development of chronic otitis media with effusion and cholesteatoma. Endoscopic transnasal balloon ET dilatation is a novel surgical technique for ET dysfunction. The main goal is to restore ET function by dilation its cartilaginous part leading to better ventilation and drainage of the middle ear. However, its real effect in the treatment of particular subgroups of patients with ET dysfunction remains unknown. Patients are mostly evaluated as one group.

Adults with chronic ET dysfunction will be strictly divided into particular subgroups and included in the study. Subgroups will be compared in order to identify treatment effect in particular subgroups.

The prevalence of Eustachian tube (ET) dysfunction in adults reaches 1%. It causes a feeling of fullness in the ear, otalgia and hearing loss and can lead to recurrent acute otitis media, development of chronic otitis media with effusion and cholesteatoma. Endoscopic transnasal balloon ET dilatation is a novel surgical technique for ET dysfunction. The main goal is to restore ET function by dilation its cartilaginous part leading to better ventilation and drainage of the middle ear. However, its real effect in the treatment of particular subgroups of patients with ET dysfunction remains unknown. Patients are mostly evaluated as one group.

Adults with chronic ET dysfunction will be strictly divided into particular subgroups and included in the study. The otomicro(endo)scopy, symptoms severity according to VAS (Visual Analogue Pain Scale), ETDQ-7 (Eustachian Tube Dysfunction Questionnaire) questionnaire, tympanometry, audiometry and the possibility of Valsalva and Toynbee maneuver will be used to evaluate the effect of balloon ET dilatation. Only patients with standard treatment failure will be included in the study. Tuboplasty with and without myringotomy will be performed (and compared) in patients with chronic otitis media with effusion. Subgroups will be compared in order to find patients who could profit from the treatments the most.

Eligibility Criteria:
Inclusion Criteria:

* adult patients with chronic Eustachian tube dysfunction lasting more than 6 months, with or without recurrence of chronic otitis media with effusion after tympanostomy

Exclusion Criteria:

* anatomic obstruction in nasopharynx
* nasopharyngeal cancer
* head and neck cancer
* other middle ear surgery except for myringotomy or tympanostomy
* chronic suppurative otitis media
* patients who could not undergo general anesthesia
* patients who did not give consent to be included in the study
Potential Injury Incidents At the FIFA World Cup Qatar 2022

This is an exploratory observational study.

Video footage is used to review all 64 matches in the football tournament.

All players actions are registered using the FIFA football language, such as, pass completed, clearance, etc.

Potential injury incidents are registered, and for each incident the injury location, contact type, player reaction, velocity, location, game reaction, referee reaction, medical staff on pitch, and outcome (e.g. substitution) are also registered.

Video footage is used to review all 64 matches in the FIFA World Cup Qatar 2022.

All players actions are registered using the FIFA football language, such as, pass completed, clearance, etc.(https://www.fifatrainingcentre.com/en/resources-tools/football-language/index.php)

Potential injury incidents are registered, and for each incident the injury location, contact type, player reaction, velocity, location, game reaction, referee reaction, medical staff on pitch, and outcome (e.g. substitution) are also registered.

Simple descriptive statistics are used to create overviews of the outcomes described above, including comparisons between actions which do or do not lead to potential injury incidents.

A secondary analysis may be performed including injury diagnoses, if players consent as part of another study on injury surveillance allowing video analysis of their injuries.

No a priori sample size calculation was performed, as all potential injury incidents are included.

Eligibility Criteria:
Inclusion Criteria:

* All participating football players at the FIFA World Cup Qatar 2022.

Exclusion Criteria:

* None
Bortezomib (Velcade) With Standard Chemotherapy for Relapsed or Refractory Follicular Lymphoma

The purpose of this study is to evaluate the effectiveness and safety of combining bortezomib (Velcade) with rituximab, fludarabine, mitoxantrone, and dexamethasone in treating patients with follicular cell lymphoma.

This is a phase II study using the combination of bortezomib, rituximab, fludarabine, mitoxantrone and dexamethasone. The combination will given over a 28 day cycle. In addition each patient will receive Pneumocystis carinii Pneumonia (PCP) prophylaxis with Trimethoprim/sulfamethoxazole (TMP/Sulfa) or equivalent agent. On day 4 the physician has the option of starting granulocyte colony-stimulating factor (GCSF), granulocyte macrophage colony-stimulating factor (GMCSF), or pegylated GCSF.

All patients who receive at least one dose of the drug will be evaluated for toxicity. Patients will be treated with the agent for at least 2 cycles to be considered eligible for evaluation of response. The chemotherapy dosing will continue until there is evidence of disease progression, a second recurrence of unacceptable toxicity, or a maximum of 8 courses of therapy.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of grade 1-3 follicular lymphoma with persistent, relapsed, or refractory disease to at least one prior regimen.
* No prior bortezomib therapy.
* Voluntary written informed consent.
* Female subject is either post-menopausal or surgically sterilized or willing to use an acceptable method of birth control.
* Male subject agrees to use an acceptable method for contraception for the duration of the study therapy.
* 18 years of age or older.
* aspartate aminotransferase (AST),alanine aminotransferase (ALT), total bilirubin \< 3 times the upper limit of normal unless documented by the treating physician to be secondary to underlying lymphoma.
* Eastern Cooperative Oncology Group (ECOG) performance status 0-2.

Exclusion Criteria:

* Platelet count of \< 50,000 within 14 days before enrollment unless documented by the treating physician to be due to the disease.
* Absolute neutrophil count of \< 1000 within 14 days before enrollment unless documented by the treating physician to be due to disease.
* Estimated or measured creatinine clearance of less than 30 ml/min within 14 days before enrollment.
* ≥Grade 2 peripheral neuropathy within 14 days before enrollment.
* Myocardial infarction within 6 months prior to enrollment or has New York Hospital Association (NYHA) Class III or IV heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia.
* Patient has hypersensitivity to boron, mannitol or any drug included in the current protocol.
* Female subject is pregnant or lactating.
* Received other investigational drugs for this disease within 14 days of enrollment
* Serious medical or psychiatric illness likely to interfere with participation in this clinical study.
* Known HIV+ status.
* Cardiac ejection fraction less than 35% at study entry measured by echocardiogram, Multigated Acquisition (MUGA) or cardiac MRI.
A Study of Mircera in Renal Anemia Among Filipino Chronic Kidney Disease Patients

This study will assess the efficacy and safety of once monthly administration of Mircera in Filipino patients with chronic kidney disease who are either on dialysis or predialysis, and not receiving erythropoiesis stimulating agents.Patients will receive Mircera at a starting dose of 0.6 micrograms/kg sc every 2 weeks, with dose adjustments until a target hemoglobin level is achieved, and then dosing will continue every 4 weeks. The anticipated time on study treatment is 3-12 months, and the target sample is \<100 individuals.


Eligibility Criteria:
Inclusion Criteria:

* adult patients, \>=18 years of age;
* chronic kidney disease;
* anemia (Hb \>8 and \<11 g/dL);
* regular dialysis or predialysis, not treated with ESA.

Exclusion Criteria:

* transfusion of red blood cells during previous 8 weeks;
* poorly controlled hypertension;
* overt gastrointestinal bleeding, or other bleeding necessitating transfusion during previous 8 weeks;
* active malignant disease (except melanoma of skin).
Novel mHealth Physical Activity Intervention for Youth With Type 1 Diabetes Mellitus

The goal of this longitudinal cohort study is to learn about a mHealth intervention in Type 1 Diabetes (T1D)

The main question\[s\] it aims to answer are:

* Does the intervention increase the amount of text messages between the mHealth software and participants?
* Do the text messages from the Nudge software increase moderate to vigorous physical activity (MVPA) in participants?
* Does the MVPA encouraged by the Nudge software improve the HbA1c levels of participants?

Participants will:

* Receive text messages from the Nudge software
* Report physical activity goals via the text messages to the Nudge software
* Wear both an accelerometer and an actigraph for three weeks (spread out across the beginning, 30 days, and 90 days of participation)
* Complete surveys at the beginning of participation
* Complete daily surveys while wearing the devices
* Complete surveys at the end of participation
* Record physical activity in study surveys


Eligibility Criteria:
Inclusion Criteria:

* Participants 12.00-21.99 years old
* Participants with a physician confirmed T1D diagnosis.
* T1D diagnosis was at least 6 months prior to study enrollment
* Participants are on an intensive insulin regiment (either with an insulin pump or multiple daily injection)
* Participants must be using a continuous glucose monitor (CGM)
* Participants and parents/legally authorized representatives (LARS) of participants less than 18.00 speak/read English.

Exclusion Criteria:

* Participants with evidence of type 2 or monogenic diabetes.
* Participants with a comorbid chronic condition (e.g., renal disease).
* Participants with presence of severe psychiatric disorders.
* Participants with a diagnosis of low vision (vision that cannot be corrected with contact lenses or eyeglasses).
* Participants with limited mobility that would prevent participant from engaging in daily physical activity, self-assessed by participant.
Textbook Outcomes in Urgent Appendectomy

A "textbook outcome" patient is defined as one whose surgical course is uneventful, with no complications, readmissions, or mortality. There is a lack of published research regarding textbook outcomes with an acute appendicitis that are treated with an appendectomy.

The objective of this study is to analyze the attainment of textbook outcomes (TO) in patients undergoing urgent appendicectomy (UA) for acute appendicitis and to identify the factors associated with achieving TO.

Eligibility Criteria:
Inclusion Criteria:

* Acute Appendicits in older than 18 years old
* Acute Appendicitis that needs appendectomy

Exclusion Criteria:

* Age under 18 years old
* Other diagnostic than an Acute Appendicitis
The Application of Novel Identified CD8 Regulatory Precursors in Inducing Immune Tolerance After Allo-HSCT

Allogeneic hematopoietic stem cell transplantation (allo-HSCT) is the most effective treatment for acute leukaemia. The reconstitution of the recipient's immune system with donor-derived HSCT cells and the development of immune tolerance are critical to the success of HSCT. Patients who fail to establish immune tolerance after transplantation develop graft-versus-host disease (GVHD), which is a serious threat to patients' lives and quality of life.

Utilising single-cell multi-omics sequencing technology, the study's principal investigator elucidated the distribution of immune cell subpopulations in patients who successfully established immune tolerance post-transplantation. This research also identified a novel group of CD8 regulatory precursors (CD8 Trps), confirming their critical regulatory role in inducing immune tolerance in post-transplantation patients. This finding suggests that this subpopulation may serve as a novel target for predicting and intervening in GVHD. The successful implementation of this project will establish a new method for early prediction of GVHD and provide a new strategy for clinical intervention of GVHD.

The goal of this observational study is to explore the sensitivity and validity of the CD8 Trps as a novel biomarker molecule for predicting the development of GVHD through a prospective clinical cohort. The main question it aims to answer is:

Can the CD8 Trps serve as an effective molecular marker for the prediction of GVHD occurrence? Can the CD8 Trps cell serve as a novel strategy for GVHD intervention?


Eligibility Criteria:
Inclusion Criteria:

1. Patients proposed for allogeneic haematopoietic stem cell transplantation;
2. Age 18\~60 years old;
3. All enrolled patients need to sign an informed consent.

Exclusion Criteria:

1. Patients with type of transplantation as unrelated or cord blood transplantation;
2. lack of patient compliance.
Fibromyalgia Integrative Training for Adolescents With Juvenile Fibromyalgia

This study evaluated whether Fibromyalgia Integrative Training program for Teens (FIT Teens), a combined cognitive behavioral therapy and neuromuscular exercise training program is more effective in reducing disability in adolescents with Juvenile Fibromyalgia compared to cognitive behavioral therapy (CBT) alone or a graded aerobic exercise (GAE) program alone. One third of participants received the FIT Teens training; one third received CBT training; and one third of participants received the GAE training.

Juvenile-onset fibromyalgia (JFM) is a chronic, debilitating pain condition that typically persists into adulthood for the majority of patients. Whereas medications offer limited and short-term symptom relief for JFM, our research group has demonstrated that cognitive-behavioral therapy (CBT) is safe, effective and durable in reducing functional disability and depressive symptoms in adolescents with this condition. However, 60% of patients receiving CBT did not show clinically significant improvement in functional disability, and pain levels remained in the moderate range despite being reduced overall. Our multidisciplinary team of experts in Behavioral Medicine, Rheumatology and Exercise Science has developed and tested the feasibility of a new Fibromyalgia Integrative Training program for Teens (FIT Teens), which enhances the established CBT intervention with a novel neuromuscular exercise training program derived from evidence-based pediatric injury prevention research. Pilot testing showed excellent patient engagement, no adverse effects and very promising early results indicating this treatment to have even stronger effects on disability and pain outcomes than CBT alone. This trial evaluated whether the FIT Teens intervention is more effective than CBT alone or graded aerobic exercise alone and whether treatment effects are sustainable over 1 year follow-up.

Eligibility Criteria:
Inclusion Criteria:

* Juvenile Fibromyalgia diagnosis by pediatric rheumatologist or pain physician and confirmed by 2010 American College of Rheumatology (ACR) criteria modified for pediatric use
* Functional Disability Score ≥ 13, indicating at least moderate disability
* Average pain intensity in the past week ≥ 4 on a 0 -10 cm Visual Analog Scale
* Stable medications prior to enrollment

Exclusion Criteria:

* Comorbid rheumatic disease (e.g. juvenile arthritis, systemic lupus erythematous)
* Untreated major psychiatric diagnoses (e.g. bipolar disorder, psychoses, symptoms of major depression) or documented developmental delay
* Any medical condition determined by their physician to be a contraindication for physical exercise
* Taking opioid pain medication
Detection and Management of Sinusitis in a Single-center Prospective Cohort of Patients with Exudative AMD (SINE)

An inflammatory component associated with AMD has been highlighted by genetic associations of predisposition to AMD, as well as by the recently demonstrated link between AMD and periodontitis.

Some patients followed at the Fondation Adolphe de Rothschild Hospital for wet AMD seemed to show an improvement of neovascular activity (less need for intravitreal injections of anti-VEGF) after treatment of their sinusitis.

The investigators would therefore like to assess the link between AMD and sinusitis, an infection close to the site of AMD.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* Patient followed and treated for at least 2 years for bilateral neovascular form of age-related macular degeneration (AMD)
* At least one eye treated with ≥ 6 intravitreal injections during the year preceding preinclusion
* Express consent to participate in the study
* Affiliated with or beneficiary of a social security plan

Exclusion Criteria:

* Persons referred to in articles L1121-5 to L1121-8 of the CSP (corresponding to all protected persons: pregnant women, parturients, nursing mothers, persons deprived of liberty by judicial or administrative decision, minors, and persons under legal protection: guardianship or curatorship).
* Severe myopia (\> 6 diopters)
* Patient already being treated for acute or chronic sinusitis
* History of central serous chorioretinopathy or diffuse retinal epitheliopathy
Preliminary Study of Piclozotan in Patients With Motor Complications Associated With Parkinson's Disease

The purpose of this study is to obtain preliminary information on the effect of piclozotan on motor complications associated with Parkinson's Disease.


Eligibility Criteria:
Main Inclusion Criteria:

* Idiopathic Parkinson's disease for at least 5 years
* Presence of motor fluctuations and dyskinesia
* Stable regimen of levodopa/carbidopa for 30 days
* At least 25% response/improvement in Unified Parkinson's Disease Rating Scale (UPDRS) part III scores after dosing with regular Parkinson's disease (PD) medications
* Mini-Mental State Examination (MMSE) score of 25 or higher

Main Exclusion Criteria:

* Atypical or secondary parkinsonism.
* Prior use of neuroleptic agents.
* History of intracranial procedures for PD.
* Active psychosis.
* History of drug or alcohol abuse in past 12 months.
* Cardiac conduction system abnormality.
* Predisposing medical condition that causes nausea or vomiting or routine use of an anti-emetic.
An Exploratory Clinical Study Non-invasive Monitoring of Cardiac Outputs

Pulsify Medical aims at developing a sensor designed for the non-invasive, continuous and real-time monitoring of cardiac hemodynamics in patients at risk based on new transducer technology and artificial intelligence. It relies on real-time 3D greyscale ultrasound reconstruction of the LV myocardium. This medical device is still under development and the main objective of this clinical investigation is to gather data on the accuracy of the current version of the sensor developed by Pulsify Medical to further guide the development of the device. The data generated will not be used for conformity assessment and this single-center prospective study on 8 patients is therefore deemed appropriate for this purpose.

During the pretreatment visit, eligibility of the subjects for the investigation will be assessed. Once subjects are considered eligible and they have consented to participate in the investigation, the visit to perform the monitoring will be scheduled. An operator will then perform on each patient two scans with the Pulsify sensor. For accurate 3D reconstruction, the ECG and breathing cycle during the acquisition will also be recorded. Immediately after acquisition with the Pulsify sensor, an echocardiographist will record a complete 2D and 3D ultrasound data set using regular ultrasound equipment used for medical examinations in the hospital. The data generated will then be used to compare the accuracy of the Pulsify sensor for cardiac output measurements with state-of-the-art ultrasound. The data will also enable to acquire a dataset of ultrasound images taken with the Pulsify sensor technology in a manner that is very close to the image capture mechanism of Pulsify's final product.


Eligibility Criteria:
Inclusion Criteria:

Healthy volunteers can participate in this study if they:

* are aged over 18 years old
* have no known cardiovascular diseases
* are willing and able to comply with all investigation related procedures

Exclusion Criteria:

* Volunteers with arrhythmias, PM or ICD
* Volunteers with life supporting electronic devices (e.g. pacemakers)
* Volunteers with bad echocardiographic windows
* Volunteers post recent thorax surgery and open chest wounds
* Volunteers with abnormal thorax configuration (COPD, scoliosis, pectus excavatum, etc.) on criteria for the selection of topics
* Women in gestation
* Women that are breastfeeding
TAP Block and Subacute Pain in Inguinal Herniography

Inguinal hernia repair with mesh has a high incidence of postoperative chronic pain. Transversus abdominis plane block is a current intervention to support postoperative analgesia, however it is recently in research area how to be applied in different surgical areas to be more effective than intravenous opioids. Subcostal transversus abdominis plane block is not advised but has not been studied to be effective for postoperative analgesia in inguinal herniography patients.

This study aims to research the effect of subcostal transversus abdominis plane block in subacute postoperative pain after inguinal hernia repair

Patients were divided into two groups, one is control and the second is subcostal transversus abdominis plane block (STAP) group. After standard general anesthesia application, control group ( Group I) had 1 gram of paracetamol and 100 mg of contramal just after starting surgical closure. Group II (STAP) had 1 gram of paracetamol and 100 mg of contramal, after surgical closure transversus abdominis plane block in subcostal area was applied to the patient.

Eligibility Criteria:
Inclusion Criteria:

* ASA I-III
* who were to undergo elective unilateral inguinal herniography with "mesh" under general anesthesia.

Exclusion Criteria:

* patients who have allergy to local anesthetics