cyrilzakka/clinical-trials huggingface dataset:
The Effect of OSA on Severity and Prognosis of Patients With CKD

This study aims to investigate the influence of obstructive sleep apnea hypopnea syndrome (OSA) on the severity and prognosis of patients with chronic kidney disease (CKD), and to evaluate the therapeutic effect of continuous positive airway pressure (CPAP) intervention in such patients. Although the study is designed as an observational cohort study, where patients self-selected whether to receive treatment rather than being assigned, there is still an intervention project, CPAP, present in the observational cohort. Through a cohort study design, scientific evidences are expected for clinical decision-making and optimize treatment strategies for patients with OSA and CKD.


Eligibility Criteria:
Inclusion Criteria:

* Diagnostic criteria: Chronic kidney disease is diagnosed based on clinical manifestations (such as hematuria, proteinuria, abnormal renal function, etc.), in accordance with the internationally recognized diagnostic criteria. Obstructive sleep apnea-hypopnea syndrome (OSAHS) is confirmed through overnight polysomnography (PSG) with an apnea-hypopnea index (AHI) of ≥5 events per hour, primarily consisting of obstructive events.
* Age and gender: Participants must be ≥18 years old, with no gender restrictions.
* Informed consent: Participants are required to voluntarily sign a written informed consent form, acknowledging and agreeing to participate in the study, including all its contents and potential risks.

Exclusion Criteria:

* Other sleep-related breathing disorders: Participants with mixed sleep apnea, central sleep apnea, or severe snoring with an AHI index of \<5 events per hour will be excluded to ensure that the study population is limited to patients with OSAHS.
* Severe internal medical conditions: Patients with severe cardiopulmonary dysfunction, malignancy, severe liver disease, mental disorders, or other severe internal medical conditions that may significantly affect sleep or the progression of kidney disease will be excluded.
* Recent surgery or medication: Individuals who have undergone surgery within the past 3 months that may affect sleep or kidney function, or who are currently using medications that may significantly interfere with sleep or the assessment of kidney disease (such as corticosteroids, immunosuppressants, novel antipsychotics, etc.) will be excluded.
* Pregnant women.
* Inability to cooperate with the study: Patients who are unable to complete the study procedures (including polysomnography, follow-up, etc.) due to cognitive impairment, language communication difficulties, remote residence, or other reasons will be excluded.
Non Randomized Humerusshaft Fracture

The aim of the study is to radiologically compare the fracture healing as well

as the functional treatment outcome of conservative and operative treatment of

defined humerusshaft fractures after 6w./12w./and 12 month based on the

modified "constant score".

Radiologically compare the fracture healing as well

as the functional treatment outcome of conservative and operative treatment of

defined humerusshaft fractures after 6w./12w./and 12 month based on the

modified "constant score".

Eligibility Criteria:
Inclusion Criteria:

* over age 16
* fracture according to AO classifications 12A2, 12A3, 12B2
* have to be available for the FU's

Exclusion Criteria:

* open fractures
* polytraumatized patients
* multiple sclerosis, paraplegic, or other conditions having a direct impact on the healing
* pseudoarthrosis
* pathological and refractures
Paclitaxel Plus Bevacizumab for Older Patients With Breast Cancer

This study will evaluate the efficacy, safety and effect on quality of life of weekly paclitaxel plus bevacizumab as first line treatment in elderly patients (≥ 70 years old) with metastatic breast cancer. Furthermore, the efficacy of the combination therapy will be correlated with the functional status of patients according to the comprehensive geriatric assessment.

Elderly individuals make up a large part of the breast cancer population. Older women are more likely than younger women to be diagnosed at a more advanced stage of breast cancer. However, when treated with chemotherapy for metastatic disease they derive similar benefits to their younger counterparts. Preference should be given to chemotherapeutic drugs with safer profiles regimens, such as weekly taxane, according to the SIOG recommendations. Recently, initial therapy of metastatic breast cancer with paclitaxel plus bevacizumab demonstrated prolonged progression-free survival, as compared with paclitaxel alone

Eligibility Criteria:
Inclusion Criteria:

* Histologically or cytologically confirmed metastatic breast adenocarcinoma
* No previous therapy (other than hormonal therapy) for metastatic disease is accepted
* Measurable disease as defined by the presence of at least one measurable lesion (except bone metastases, ascites or pleural effusions)
* Performance status (WHO) 0-2
* Adequate liver (serum bilirubin \<1.5 times the upper normal limit, AST and ALT \<2.5 times the upper normal limit in the absence of demonstrable liver metastases, or \<5 times the upper normal limit in the presence of liver metastases)
* adequate renal function (serum creatinine \<1.5 times the upper normal limit)
* bone marrow (neutrophils ≥ 1.5x 109 /L, and platelets ≥ 100x 109 /L)
* No radiation of measurable disease (except brain metastases)
* No progressive brain metastases according to clinical or radiological criteria
* No brain metastases without prior radiation therapy
* Written informed consent

Exclusion Criteria:

* Active infection
* History of significant cardiac disease (unstable angina, congestive heart failure, myocardial infarction within the previous 6 months, ventricular arrhythmias)
* History of stroke
* Anticoagulation therapy (except of low dose aspirin \<325mg)
* Other invasive malignancy except non-melanoma skin cancer
* Psychiatric illness or social situation that would preclude study compliance
* Pregnant or lactating women
Real-World Treatment Patterns and Patient Reported Outcome in COPD (REMIND)

This retrospective observational study aims to report distribution of the proportion of symptomatic Chronic obstructive pulmonary disease (COPD) patients classified by the COPD Assessment Test (CAT) managed with single or dual inhaler treatment using the data at cohort entry in the COPD cohort study, and treatment change and longitudinal CAT score by each inhaler treatment will also be evaluated using the data during the follow-up period.


Eligibility Criteria:
Inclusion Criteria:

* Patients taken with any of following inhaler treatments; LAMA, LAMA+LABA(both single and dual inhaler) or ICS+LABA(both single and dual inhaler) at cohort entry

Exclusion Criteria:

* Patients enrolled at the sites participated in the COPD cohort study where not agreed on secondary use of data for this study
An Open, Multicenter, Randomized, Dose-Ranging Study of Azithromycin in the Treatment of Disseminated Mycobacterium Avium-Intracellulare Complex Infection (MAC) in Patients With Acquired Immune Deficiency Syndrome (AIDS)

To evaluate the efficacy and safety of two doses of azithromycin given chronically for the treatment of Mycobacterium avium bacteremia in AIDS patients.


Eligibility Criteria:
Inclusion Criteria

Concurrent Medication:

Allowed:

* Medications allowed under a Treatment IND program.

Patients must have:

* HIV infection.
* Disseminated Mycobacterium avium Complex.
* Fever (\> 100 degrees F) that cannot be attributed to another active infection, and at least one other constitutional symptom (such as fatigue, malaise, anorexia).
* Life expectancy of at least the duration of the study.
* Consent of parent or guardian if below the legal age of consent.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms and conditions are excluded:

* Known hypersensitivity or significant intolerance to macrolide antibiotics.
* Inability to take oral medications or a current condition likely to interfere with drug absorption (e.g., gastrectomy).

Prior Medication:

Excluded:

* Treatment with an immunostimulant or immunomodulator compound such as alpha-interferon, gamma-interferon, or any interleukin within 7 days prior to study entry.
* Any other antibiotic with known activity against M. avium within 7 days prior to study entry.

Not expected to comply with the requirements of the protocol, in the opinion of the investigator.
Treosulfan-based Conditioning for Allogeneic Stem-cell Transplantation (SCT) in Lymphoid Malignancies

The study hypotheses is that the introduction of dose escalated treosulfan, in substitution to busulfan or melphalan, will reduce toxicity after allogeneic transplantation while improving disease eradication in patients with lymphoid malignancies not eligible for standard transplantation.


Eligibility Criteria:
Inclusion Criteria:

1. Age less than physiologic 68 years.
2. Patients with NHL and HL with an indication for allogeneic transplantation as follows:

   * Aggressive lymphoma and Hodgkin lymphoma; relapse after autologous transplants
   * Follicular lymphoma; failure of at least one prior regimen
3. Disease must be at chemo-sensitive or stable status to prior therapy before transplant.
4. Patients must have an HLA matched related or unrelated donor willing to donate either peripheral blood stem cells or bone marrow. Matching is based on high-resolution class I (HLA-A, -B, -C) and class II (HLA-DRB1, -DQB1) typing. The goal is to transplant \> 3 x 106 CD34+ cells per kg body weight of the recipient
5. Patients must sign written informed consent
6. Adequate birth control in fertile patients

Exclusion Criteria:

1. Overt progressive disease prior to transplantation.
2. Bilirubin \> 3.0 mg/dl, transaminases \> 3 times upper normal limit
3. Creatinine \> 2.0 mg/dl
4. ECOG-Performance status \> 2
5. Uncontrolled infection
6. Pregnancy or lactation
7. Abnormal lung diffusion capacity (DLCO \< 40% predicted)
8. Severe cardiovascular disease
9. CNS disease involvement
10. Pleural effusion or ascites \> 1 liter
11. Known hypersensitivity to fludarabine or treosulfan
12. Psychiatric conditions/disease that impair the ability to give informed consent or to adequately co-operate
Clinical Evaluation of Pink Esthetic Score

Clinical evaluation of pink esthetic score in delayed implants in thin gingival biotype with and without temporization in the esthetic zone

Clinical evaluation of the pink esthetic score with and withiut temporization in thin gingival biotype in the maxillary esthetic zone with subepithelial connective tissue graft in bith groups

Eligibility Criteria:
Inclusion Criteria:

* patients with missing teeth in the maxillary esthetic zone with thin gingival biotype and adequate arch space

Exclusion Criteria:

* deficient ridge , crowns on the adjacent teeth
Efficacy of Endoscopic Subureteral Injection for Vesicoureteral Reflux in Adults With Decreased Bladder Compliance

Endoscopic subureteral injection for vesicoureteral reflux has become an established alternative to ureter reimplantation in children. Some recent studies suggest that ESI can be also a primary treatment option for VUR in adults. However, the experience with ESI in adults who have VUR associated with decreased bladder compliance is limited. We evaluated the efficacy of endoscopic subureteral injection treatment for vesicoureteral reflux in adults with decreased bladder compliance.


Eligibility Criteria:
Inclusion Criteria:

* Who is aged 18 and greater
* Who underwent endoscopic subureteral injection for vesicoureteral reflux

Exclusion Criteria:

* Medical records of whom is not evaluabe
Assessing eFficacy and Safety of DEXTENZA 0.4 mg inseRt, Following Corneal Transplant Surgery

Assessing the efficacy and safety of DEXTENZA, sustained release dexamethasone 0.4 mg insert following corneal transplant surgery (PKP, DSEK, DMEK) as compared to topical prednisolone acetate 1%.

Assessing the efficacy and safety of DEXTENZA, sustained release dexamethasone 0.4 mg insert, when placed within the lower or upper eye lid canaliculus in conjunction with topical prednisolone acetate 1% for the treatment of pain, and inflammation following corneal transplant surgery (PKP, DSEK, DMEK) as compared to topical prednisolone acetate 1%.

Eligibility Criteria:
Inclusion Criteria: A patient's study eye must meet the following criteria to be eligible for inclusion in the study:

* Age 18 years and older
* Scheduled corneal transplant surgery: PKP, DSEK, DMEK
* Willing and able to comply with clinic visits and study related procedures
* Willing and able to sign the informed consent form

Exclusion Criteria: A patient who meets any of the following criteria will be excluded from the study:

* Patients under the age of 18.
* Pregnancy (must be ruled out in women of child-bearing age with pregnancy test)
* Active infectious systemic disease
* Active infectious ocular or extraocular disease
* Presence of punctal plug in the study eye
* Obstructed nasolacrimal duct in the study eye(s)
* Hypersensitivity to dexamethasone or prednisolone eye drops
* Patients being treated with immunomodulating agents in the study eye(s)
* Patients being treated with immunosuppressants and/or oral steroids
* Patients with severe disease that warrants critical attention, deemed unsafe for the study by the investigator
Pre-operative Steroids in CRSsP

Randomized controlled trial to determine the effectiveness of a five-day course of pre-operative oral steroids on decreasing intra-operative blood loss during endoscopic sinus surgery.

The study will be a randomized cohort study, and patients will be recruited before surgery. Following randomization, patients will be given either a course of Prednisone (30 milligrams per day for 5 days, to be started five days prior to surgery) or no additional pre-operative prescriptions besides what is clinically determined by their treating physician. Patients will be scheduled for surgery and undergo functional endoscopic sinus surgery with timing as clinically indicated.

During endoscopic sinus surgery, surgical video will be recorded and stored on encrypted, flash drives with unique, non PHI, indicators to identify drives. Subsequently, each video will be graded by two, blinded surgeons for field visualization and thoroughness of dissection. Intra-operative blood loss will also be recorded. Post-operative data through 30 days post-operatively will be collected including: post-operative complications, resolution of symptoms, and nasal crusting during post-operative follow up. Following completion of data collection, these data will be analyzed by a separate, blinded investigator.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients between the ages of 18 and 99 years of age with a diagnosis of chronic rhinosinusitis without polyps who are being scheduled for functional endoscopic sinus surgery

Exclusion Criteria:

* Patients under 18 years old, patients with a condition in which the use of systemic corticosteroids is contraindicated (poorly controlled diabetes mellitus, poorly controlled hypertension, active or untreated tuberculosis, active viral or fungal infection, acute angle glaucoma, osteoporosis, or acute congestive heart failure) patients allergic to corticosteroids, or, patients unwilling or unable to take the prescribed course of pre-operative steroids.
The Effect of Dexmedetomidine on Postoperative Analgesia

The purpose of this study is to determine whether additional Dexmedetomidine to patient controlled analgesia can reduce fentanyl consumption.


Eligibility Criteria:
Inclusion Criteria:

* Elective surgery for colon cancer

Exclusion Criteria:

* Liver disease
* Kidney disease
* Allergy for study drugs
* Inability to receive patient controlled analgesia
QTX3544 in Patients with Advanced Solid Tumors with KRAS G12V Mutations

Phase 1 study to determine the safety, tolerability, and anti-tumor activity of QTX3544 as a single agent or in combination with cetuximab.


Eligibility Criteria:
Inclusion Criteria:

* Pathologically documented, locally advanced or metastatic malignancy with KRAS G12V mutations identified through molecular testing (NGS- or PCR-based) with a Clinical Laboratory Improvement Amendments-certified (or equivalent) diagnostic.
* Part 1: Advanced solid tumors with at least one prior systemic therapy.
* Evaluable and measurable disease per RECIST v1.1.
* Part 2 and 3: Measurable disease per RECIST v1.1.

Exclusion Criteria:

* Active brain metastasis or carcinomatous meningitis
* Significant cardiovascular disease
* Active infection requiring intravenous (IV) antibiotics
* Prior treatment with a KRAS inhibitor

Other protocol-defined Inclusion/Exclusion Criteria may apply
Neuropsychological Development and Functional Outcome Sin Children With Hirschsprung Disease at School Age

Hirschsprung's disease (HD) is a rare congenital disease (1:5000) characterized by neonatal functional low bowel obstruction that is caused by aganglionosis of the distal bowel. HD treatment consists in surgery of colonic reduction in the early childhood, requiring afterward a long-term follow-up. In the long term complications (incontinence, constipation, enterocolitis, soiling)but also iterative anesthesia in childhood and repeated hospitalizations can have negative effects on child's development.

The main aim of the study is to estimate neuropsychological development at school age (6-10 years). Of children operated of HD Secondary aims are evaluation of the neuro-driving development and global health, comparison of quality of life levels to those of French population standards as well as to study the complex relations between on one hand the quality of life of these children and on the other hand the socio-demographic data, the initial clinical elements and the surgical coverage, as well as their health and current cognitive profile.

This multicenter study included pediatric surgery departments of Marseille. All children born between 1/1/2005 and 31/12/2010 and presenting HD represent the population. All the families will be contacted resting on the networks of set up follow-up. A written agreement will be collected with the parents. For all the participating children, a consultation will be organized: quality of life data (reported by children and by their parents in validated standardized questionnaires), clinical examination of the child, cognitive profile of the child. The duration of inclusion is scheduled for 12 months.

This is the first French study using auto-reported data on children's quality of life at school age affected by a HD. The results of this study will allow developing hypotheses on predictive risk factors for neuropsychological development disorders. Besides a better knowledge of the relation existing between these children quality of life and their functional results due to the disease could help clinicians in their medical reflections.


Eligibility Criteria:
Inclusion Criteria:

* Child aged 8 to 13
* Child with Hirschsprung's disease (diagnosis confirmed by anatomopathological analysis),
* Child with no severe cerebral palsy
* Child with no developmental psychosis
* Child not showing amblyopia
* Child not deaf hearing
* Child able to answer a questionnaire in French language,
* a child whose parents or legal representatives have accepted the principle of participation in this study, and who have signed an informed consent,

Exclusion Criteria:

* Child deceased between birth and the date of assessment,
* Child with cerebral palsy
* Child whose parents or legal representatives refused to allow their child to participate in this study
A Trial Comparing Interpersonal Therapy to Exposure Therapy for PTSD Due to Military Sexual Trauma (MST) in Male and Female Military Personnel

The purpose of this study is to compare two kinds of therapy for Posttraumatic Stress Disorder (PTSD): exposure therapy (ET) and Interpersonal Psychotherapy (IPT). The results of this study will allow us to see if IPT and ET are equally effective in treating PTSD due to Military Sexual Trauma, with the long-term goal of making PTSD treatment effective for as many people as possible.


Eligibility Criteria:
Inclusion Criteria:

* English-speaking
* Military Sexual Trauma (MST) survivors, with MST defined as actual or threatened sexual violence, from Vietnam era to current Operation Iraqi Freedom/Operation Enduring Freedom/Operation New Dawn
* Diagnosed with PTSD consequent to MST, with a minimum CAPS score \> 40
* Medically stable at time of study enrollment (for persons with chronic injuries and that any disability present does not prevent attendance of weekly outpatient therapy sessions)
* Ability to provide informed consent and function at an intellectual level sufficient to allow accurate completion of all assessment instruments
* Stable on psychotropic medication for the prior 60 days

Exclusion Criteria:

* Lifetime or current diagnosis of schizophrenia or other psychotic disorder, bipolar disorder
* Participation in a clinical trial or concurrent evidence-based treatment for MST-related psychiatric conditions or PTSD during the previous 3 months
* Current evidence of significant unstable medical illness or organic brain impairment such that the patient could not attend sessions regularly or complete assessments
* Patients who in the investigator's judgment pose a current homicidal or suicidal risk
* Current or history of substance dependence in the past 90 days.
Piloting the IPROACTIF Program to Preserve Functioning and Prevent Cognitive Decline

Conduct a pilot randomized control to assess the preliminary efficacy of IPROACTIF, an occupational therapist-delivered primary care intervention for aging and chronic disease management.

The IPROACTIF intervention is based on the premise of preventing the physical and cognitive decline that is associated with aging and chronic disease. The 12-week intervention includes a comprehensive assessment of ADL functioning and ten intervention sessions addressing disease management, physical activity and executive functioning. This pilot randomized control trial will compare whether patients who receive IPROACTIF perform better than usual care patients on physical functioning, self-efficacy for chronic disease management, physical activity levels, executive functioning, health-related quality of life, and participation in life roles and activities.

Eligibility Criteria:
Inclusion Criteria:

* English speaking
* Community-dwelling
* 55 years of age
* Primary diagnosis of heart disease (coronary artery disease, ischemic heart disease, hypertensive heart disease), or uncontrolled diabetes (HBA1c greater than/equal to 10)
* Self-reported risk of functional decline (score of 3 or higher) on the 11-item Brief Risk Identification of Geriatric Health Tool or self-reported need for assistance with disease management

Exclusion Criteria

* Current/past diagnosis of stroke or other neurological disorders
* Receiving pharmacological treatment for cognition
* Participating in other exercise or ADL-focused intervention studies
* Non-English speaking
* Residing in a long-term care institution
* Compromised decision-making capacity (score \>8 on SOMCT)
Drug-Eluting Registry: Real-World Treatment of Lesions in the Peripheral Vasculature

The ELEGANCE Registry's objective is to collect Real-World Data (RWD), including populations previously not represented in Peripheral Vascular Disease (PVD) trials, health economics data, and to support the safe use of commercially available Boston Scientific Corporation (BSC) drug-eluting devices for the treatment of lesions located in the peripheral vasculature.

A global prospective, non-randomized, open-label, multi-center Registry to collect Real-World Data, including health economic data, to support the use of commercially available drug-eluting BSC devices for the treatment of lesions located in the peripheral vasculature.

Eligibility Criteria:
Inclusion Criteria:

* Patients 18 years and older
* Written informed consent (patient data release-form)
* Use of any commercially available Boston Scientific drug-eluting device marketed for treatment of lesions in the peripheral vasculature and specified in the Registry Enrollment Guide

Exclusion Criteria:

* Life expectancy of \<1 year