cyrilzakka/clinical-trials huggingface dataset:
Efficiency Study of Aspirin to Prevent the Occurrence of Prostate Cancer

Though the pathogenesis of prostate cancer (PCa) is still obscure, it has been reported, by investigators previous studies and some other researches, that PCa is often combined with tissue inflammation which is closely related to prostate specific antigen (PSA) level. Inflammation could play an important role in the process of occurrence and development of PCa, however the mechanism is unknown. Inflammatory cytokines could not only mediate inflammatory reactions, but also participate in the growth, proliferation, invasion and progression of tumor cells. It has been found that non-steroid anti-inflammatory drugs (NSAIDs), such as aspirin, can effectively prevent several inflammation related tumor, and coincidentally, PCa is also closely associated with inflammation. Moreover, latest researches demonstrated that hormone therapy could induce tissue inflammation in PCa, in which a large quantity of immune B cells were attracted into the focal and then a lot of cytokines, such as IKK-β, NF-κB, were released. These cytokines could inhibit apoptosis and promote the growth of tumor cells, which might be a possible mechanism for long-term inflammatory infiltration inducing the occurrence of PCa and the transformation to castration-resistant prostate cancer (CRPC). Based on these proofs, investigators presume it could be possibly an effective way to prevent the occurrence of PCa and the transformation from androgen-dependent prostate cancer to CRPC by means of long-term oral aspirin. In this study, investigators intend to explore the possible effect of anti-inflammatory therapy on the progress of transformations from inflammation to PCa and from androgen-dependent prostate cancer to CRPC. Investigators plan to conduct both clinical trials in four groups, including the control group, the NSAIDs group, the antibiotics group and the NSAIDs+antibiotics group, and a basic experiment in vitro to assess the effectiveness of anti-inflammatory drugs and elucidate the specific molecular mechanism.


Eligibility Criteria:
Inclusion Criteria:

* Prostate Specific Antigen(PSA)\>10ng/ml
* Suspected of Prostate Cancer
* Prostate Biopsy showed Benign Prostate Hyperplasia with infiltrated with lymphocytes

Exclusion Criteria:

* Serious Complication:heart disease;respiratory disease;blood disease;
* refused to join the trial
* Disease of hemorrhagic tendency
Chronic Abdominal Pain After Gastric Bypass

The study aims to explore patients perception of chronic abdominal pain after Roux en Y gastric bypass surgery for morbid obesity. The investigators aim to describe characteristics of symptoms of pain. Potential risk factors for developing abdominal pain post gastric bypass will be explored.

This is a single-center, prospective, longitudinal, cohort study performed at the Department of Morbid Obesity and Bariatric Surgery, Oslo University Hospital. Patients undergoing gastric bypass are eligible for inclusion. The study is approved by the Regional Committee for Medical and Health Research Ethics (no.2013/1263), South-East health region. All participants provide written consent for study paennrollment.

The participants are asked to fill inn a set of questionnaires before and during follow-up after gastric bypass surgery. Symptom characteristics are explored and evaluated. Quality of life is included in the analyses. The main outcome is findings at 2 years post surgery, but the patients will be followed for 5 years.

The investigators also aim to evaluate by objective measures the patients perception of pain by temperature and skin pressure stimulants before and after surgery (2 years).

Eligibility Criteria:
Inclusion Criteria:

• Indication for gastric bypass surgery i.e. BMI \> 40 kg/m2 or BMI \> 35 kg/m2 and obesity related comorbidity following failed attempts of sustained weight loss

Exclusion Criteria:

* Other indications for gastric bypass surgery than obesity
* Previous bariatric surgery
* Other concomitant surgical procedures for abdominal pain such as cholecystectomy
Effect of Vestibular Rehabilitation on Static Posturography Results

Thirty subjects with unilateral vestibular hypofunction diagnosed by videonystagmography (VNG) were voluntarily included in the study. In addition to Static Posturography test, head thrust test, Unterberger test, bucket test, eyes open/closed tandem stance test, eyes open/closed semitandem stance test, Romberg test, one leg standing on foam floor with eyes open/closed and before vestibular rehabilitation treatment In the initial evaluations, the Visual Analogue Scale (VAS) and the Dizziness Disability Inventory (DHI) were applied to assess the severity of standing on one leg with eyes open/closed, dynamic visual acuity, vertigo, and fatigue. As a result of the study, it was concluded that vestibular rehabilitation is beneficial in patients with unilateral vestibular hypofunction and its effectiveness can be monitored with Static Posturography.

Patients were re-evaluated after 8 weeks of vestibular rehabilitation and the results were compared. The vestibular rehabilitation program was changed every two weeks. During the eight-week period, the patients performed the exercise program 3 times a day with 10 repetitions of each exercise. According to the evaluation results after the treatment, there was a statistically significant improvement in static posturography, especially in the modified-CTSIB test. There was a statistically significant improvement in dynamic visual acuity, head thrust test, bucket test, standing on one leg on firm and foam ground with eyes open/closed, tandem stance test with eyes closed, and Unterberger test. Statistically significant scores were obtained in VAS and DHI results.

Eligibility Criteria:
Inclusion Criteria:

* Individuals diagnosed with unilateral vestibular hypofunction by VNG
* Individuals aged 18-65
* Normal otomicroscopic examination

Exclusion Criteria:

* Individuals with neurological disorders
* Having physical problems that may interfere with walking
* Central finding as a result of the VNG test
* Pathology in temporal bone MRI
* Having a cognitive impairment that prevents communication
* Have a severe visual impairment
Healthy Activities Improve Lives (HAIL)

The investigators have developed an online platform to support the 8-week, F\&S! exercise program called the Healthy Activity Improves Lives (HAIL) online platform. The aim of this study is to perform a cluster randomization of four racially diverse churches or senior centers to either the standard F\&S! program, or the combined HAIL Online Platform + F\&S! program to examine the efficacy of the HAIL online platform + F\&S! program for older adults in black communities.

This is randomized clinical trial of cluster randomization evaluating the efficacy and feasibility of the HAIL online platform + F\&S! program. We will enroll four cohorts (i.e., at two racially diverse churches or senior centers) for a total number of 120 participants. We will use a phone screen to assess participants' eligibility and explain the study procedures. Eligible individuals will then be given a link to complete an e-Consent in REDCap. Those randomized into the intervention group will also receive instructions on how to access the HAIL online platform to complete assessments as part of the baseline visit. Participants in both the intervention and comparison groups will complete the 8-week F\&S! exercise program which will be delivered in-person as well as remote. Participants in the intervention group will have access to the adjunct HAIL online platform during the F\&S! program, and then continue to use the HAIL online platform during the 3-mo follow-up.

Eligibility Criteria:
Inclusion Criteria:

* Individuals over the age of 60 years
* Participants are able to travel to one of the churches for the in-person F\&S! exercise sessions
* Participants cannot be currently participating in a regular PA program (i.e., at least 100 min per week of moderate to vigorous physical activities)

Exclusion Criteria:

* Participants do not understand study procedures or are unable to participate in the verbal consent process
* Participants must have a physician responsible for their medical care
* Participants endorse an item on the Revised Physical Activity Readiness Questionnaire (rPAR-Q) as confirmed by their treating physician
* Participants who report any contraindication to exercising (e.g., recent ECG changes or myocardial infarction, unstable angina, uncontrolled arrhythmias, third degree heart block, congestive heart failure)
* Participants who receive a score of 28 or higher on the Telephone Interview for Cognitive Status (TICS) during pre-screening
Safety and Efficacy of VSJ-110 in the Treatment of Allergic Conjunctivitis in Adults With a History of Ocular Allergies

The purpose of this study is to determine the safety and efficacy of VSJ-110 compared to placebo in the treatment of allergic conjunctivitis using an antigen challenge model


Eligibility Criteria:
Inclusion Criteria:

* At least 18 years of age of either gender and any race
* Able to provide written informed consent and sign the HIPAA form
* Willing and able to follow all instructions and attend all study visits

Exclusion Criteria:

* Able and willing to avoid all disallowed medications during washout and study period
A Modified Lateral Lumbar Interbody Fusion VS. Transforaminal Lumbar Interbody Fusion for Adult Degenerative Scoliosis

A modified lateral lumbar interbody fusion VS. transforaminal lumbar interbody fusion for the treatment of adult degenerative scoliosis with 2 year follow-up with a multiple center, randomized case-control study

Adult degenerative scoliosis (ADS) is the most common spinal deformity in the elderly, and the severe patients need surgical treatment. The elderly are often complicated with many medical diseases and the perioperative risk is high, so minimally invasive surgery is a new choice for spinal surgeons to treat ADS. Modified lateral lumbar interbody fusion (CLIF) is an new modified spinal minimally invasive interbody fusion technique in the investigator's department. The results of preliminary studies showed that it has the advantages of less trauma, short operation time and fewer complications, and the clinical and imaging outcome are remarkable. Therefore, the present study aims to establish a multicenter, large sample prospective randomized controlled study to explore the technical advantages and surgical indications of the new technique in the treatment of ADS by comparing with the traditional posterior spinal interbody fusion; (2) to compare the postoperative clinical and imaging results and analyze the surgical complications and preventive measures; (3) to establish a long-term follow-up to further quantify the clinical and imaging outcome of the new technique. Therefore, this study will further verify the safety and effectiveness of the CLIF in the treatment of ADS on the basis of previous studies, and provide a new clinical approach for minimally invasive treatment of ADS.

Eligibility Criteria:
Inclusion Criteria:

* at least 50 years of age, diagnosed with adult thoracolumbar scoliosis including any number of intervertebral levels between T8 and S1, unresponsive to conservative treatment for at least 6 months, and had a preoperative coronal Cobb angle of at least 10° and preoperative ODI score of at least 30%.

Exclusion Criteria:

* with prior lumbar fusion surgery or spondylolisthesis greater than Grade II
Stent Thrombosis After Tandem Lesions Thrombectomy

The aim is to describe the rate of delayed stent thrombosis after endovascular management of consecutive tandem lesions, in a patient series with systematic follow-up of stent patency. In addition, Investigatros aim to research baseline patient characteristics that are associated with a higher risk of delayed stent thrombosis and to evaluate the clinical consequences of stent thrombosis


Eligibility Criteria:
Inclusion Criteria:

* Patients who underwent endovascular treatments for acute ischemic stroke in Strasbourg University Hospitals between 01/01/2009 and 01/04/2018
* Association of extracranial internal carotid artery (ICA) occlusion or stenosis ≥70% using NASCET criteria and an intracranial arterial occlusion in the anterior circulation

Exclusion Criteria:

- Endovascular treatments for complication of surgical carotid endarterectomy
HoLEP Vs BipolEP in Management of BPH Patients with Large Prostates

This is a non-inferiority prospective randomized comparative clinical trial aiming to prove the non-inferiority of bipolar enucleation of the prostate in comparison to holmium laser enucleation of the prostate in management of benign prostatic hyperplasia patients with large prostates and in turn its feasibility as an alternative procedure in hospitals with limited resources

Benign prostatic hyperplasia (BPH) is a prevalent condition among older men. It is characterized by non-cancerous enlargement of the prostate gland often leading to urinary obstruction and significant morbidity. In case of failure of medical treatment, surgical intervention is often required especially in patients with larger prostates. Surgical options in such cases include Holmium Laser Enucleation of the Prostate (HoLEP) and Bipolar Enucleation of the Prostate (BipolEP). These modalities have emerged as promising relatively minimally invasive treatment options in patients with large prostates. HoLEP, utilizing laser technology to enucleate prostatic tissue, has been associated with reduced intraoperative blood loss, shorter catheterization time, and quicker recovery in comparison to open prostatectomy. Likewise, BipolEP, utilizing bipolar energy for enucleation, offers the advantage of reduced bleeding and shorter operative time. Both HoLEP and BipolEP have demonstrated efficacy in improving lower urinary tract symptoms (LUTS) and alleviating obstruction in BPH patients with large prostates, but the comparative efficacy and safety of both techniques remains highly debated. This study aims to compare the efficacy and safety of these two surgical modalities aiming to provide valuable insights that can enhance clinical decision-making and patient care in BPH management.

Eligibility Criteria:
Inclusion Criteria:

* Age \>50 years
* Prostate volume \>80 ml
* Failure of or noncompliance with medical treatment
* IPSS \>15
* Qmax \<15 ml/sec
* Urinary retention and fixed catheters with poor results on trial of voiding without catheter

Exclusion Criteria:

* Patients with active UTI
* Prostate cancer
* Bladder carcinoma
* Urethral stricture
* Neurogenic bladder disorders
* Redo cases
Fungal Infection After Oral Cavity Surgeries

this prospective study we will examine the prevalence of fungal infection in patients undergoing oral cavity surgery without treatment with antifungal drug


Eligibility Criteria:
Inclusion Criteria:

* Age over 18

Exclusion Criteria:

* Previous oral cavity surgery.

  * Previous radiotherapy to the head and neck.
  * Previous treatment with antifungal drugs in the 30 days preceding the surgery Immunocompomised state at the date of surgery.
  * Pregnancy
  * Lack of follow-up
A Study of CAR-T Cells Targeting Autoimmune Diseases

The purpose of this study is to assess the safety and efficacy of CAR-T cell therapy in patients with autoimmune disease.

Autoimmune disease refers to the disease in which the immune system reacts to the host's own body and causes damage to tissues and organs.

Autoreactive B cells can self-activate and differentiate into plasma cells releasing large amounts of autoantibodies, while they can also present their own antigens to autoimmune T cells, thus activating T cells and promoting the release of inflammatory factors.

CAR-T cells can theoretically completely deplete abnormal antibody-producing B cells, allowing immune rebuilding and restoring the patient's normal immune function, achieving drug-free survival, which fully reflects the application prospects of CAR-T therapy in autoimmune disease.

Eligibility Criteria:
Inclusion Criteria:

1. Male or female, between 18 and 56 years old;
2. Diagnosed with Autoimmune Diseases；
3. Good organ functions;
4. Voluntary participates this trial and can comprehend and sign ICF.

Exclusion Criteria:

1. Had or has active malignancy;
2. Had been subjected to treatment by CD19 targeted therapy or CAR-T therapy or any gene therapy;
3. Combined with other autoimmune disease that needs treatment;
4. Pregnant or lactating women;
5. Has other factors that deemed not suitable by investigator.
A Study of IBI302 in Patients With nAMD

This is a multi-center, randomized, double-blind, active-controlled study to evaluate the efficacy and safety of IBI302 in subjects with neovascular age-related macular degeneration.


Eligibility Criteria:
Inclusion criteria

1. Male or female patient ≥ 50 yrs. of age.
2. Active subfoveal or parafoveal CNV secondary to neovascular AMD.
3. BCVA score of 24-73 letters using ETDRS charts in the study eye.
4. Willing and able to sign informed consent form and comply with visit and study procedures per protocol.

Exclusion criteria

1. Concomitant diseases that may cause subjects fail to respond to the treatment or confuse the interpretation of the study results;
2. Presence of uncontrolled glaucoma in the study eye (defined as IOP≥25mmHg despite the standardized treatment);
3. Presence of active intraocular or periocular inflammation or infection;
4. Prior any treatment of following in the study eye:

   1. Anti-VEGF therapy or anti-complement therapy within 3 months prior to screening;
   2. Laser photocoagulation within 3 months prior to screening;
   3. Photodynamic therapy or vitreoretinal surgery;
   4. Intraocular glucocorticoid injection within 6 months prior to enrollment;
5. Presence of any systemic disease: including but not limited toactive infections (such as active viral hepatitis); unstable angina; cerebrovascular accident or transient cerebral ischemia (within 6 months prior to selection); myocardial infarction (within 6 months prior to selection); serious arrhythmia requiring medical treatment; liver, kidney or metabolic diseases; or malignant tumor;
6. History of severe hypersensitivity/allergy to active ingredients or any excipients of the study drug, or fluorescein and povidone iodine;
7. Pregnant or lactating women or women preparing to become pregnant or breastfeeding during the study period;
8. Participated in any clinical study of any other drug within three months prior to enrollment, or attempted to participate in other drug trials during the study;
9. Other conditions unsuitable for enrollment judged by investigators
A Study of Fluoroquinolones Exposure and Collagen-Related Serious Adverse Events

The purpose of this study is to evaluate whether there is an increased risk of achilles tendon rupture (ATR), retinal detachment (RD) or aortic aneurysm and dissection (AAD) following exposure to fluoroquinolone (FQ) or other antibiotics (amoxicillin, azithromycin, trimethoprim and trimethroprim/sulfamethoxazole) or febrile illness not treated with antibiotics, using a study design that minimizes the impact of confounders not usually captured in health services databases such as heredity or smoking.


Eligibility Criteria:
Inclusion Criteria:

* Have evidence of at least 1 instance of Achilles Tendon Rupture (ATR) or Retinal Detachment (RD) or Aortic Aneurysm and Dissection (AAD)
* Have at least 1 exposure to Fluoroquinolones or any of the other antibiotics (amoxicillin, azithromycin, trimethoprim and trimethroprim/sulfamethoxazole) or febrile illness not treated with antibiotic
* Have at least 1 year of continuous enrollment with pharmacy benefits prior to the ATR, RD or AAD

Exclusion Criteria:

ATR, AAD and RD cohorts:

- Participants who experience the index event while within a time-at-risk window for more than one exposure type. (The exposure types in this study include FQ as a class, amoxicillin, azithromycin, trimethoprim, trimethroprim/sulfamethoxazole, and febrile illness not treated with antibiotics. Events while within a time-at-risk window of two or more exposure types cannot be associated with any one exposure. Participants are therefore excluded from the study)

For ATR and AAD cohorts:

* Have inherited disorders of connective tissue, specifically: Ehlers-Danlos syndrome, epidermolysis bullosa, Marfan syndrome, osteogenesis imperfecta
* Have an ATR or AAD event prior to index, during the 1-year pre-index period

For RD cohort:

* Have cataract surgery prior to index
* Have iridotomy or iridectomy prior to index
Pharmacokinetics of G3139 in Subjects With Advanced Melanoma, Including Those With Normal Hepatic Function and Those With Moderate Hepatic Impairment

This is an open-label, parallel-group study with a total of 16 evaluable subjects. Subjects will be assigned to 1 of the following cohorts: Cohorts I (subjects with normal hepatic function; n+8 and Cohort II (subjects with moderate hepatic impairment, Child-Pugh classification Grade B; n=8). If, for any reason, the Genasense infusion is interrupted or discontinued prior to completion or the rate of administration of the Genasense infusion is changed, the subject will be replaced.


Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed diagnosis of malignant melanoma
* Metastatic Stage IV disease, or Stage III disease that is not surgically resectable
* ECOG Performance status of 0,1,or 2
* Adequate venous access
* Agreement to practice effective methods of birth control
* Hepatically impaired consistent with Child-Pugh classification Grade B

Exclusion Criteria:

* Chronic intravascular coagulopathy confirmed by the presence of fibrinogen degradation products, metastases to the liver, or exudative ascites
* Prior organ allograft
* Requirement for concomitant anticoagulant therapy (with the exception of 1 mg/day of warfarin for central line prophylaxis) while receiving protocol therapy
* Known hypersensitive to DTIC
* Prior treatment with Genasense
High Flow Nasal Oxygen Therapy for Hypoxemy After Cardiac Surgery

The main objective of this study is to evaluate the gas exchange (ventilation-perfusion ratio) with the system Optiflow® compared to facial mask among patients having an acute respiratory failure after cardiac surgery.


Eligibility Criteria:
Inclusion Criteria:

* Patient with indication of coronary artery bypass
* Absence of preoperative respiratory failure
* Hypoxia after extubation defined as SpO2 \< 96% with Venturi mask 50% 8L/min
* Age \> 18 years
* Signed informed consent

Exclusion Criteria:

* Patients requiring an imminent intubation, in coma or respiratory exhaustion, in a state of shock or severe rhythm disorders
* Hemodynamic instability, low flow rate
* Pneumothorax or hemothorax
* Bleeding major, ischemic signs
* Ventricular arrhythmia
* Respiratory failure
* Non controlled hyperalgia
* Alteration of mental status
* Cardiac surgery patients in post-operative valve surgery associated with coronary artery bypass surgery or isolated valve surgery
* Pregnancy
* Major under guardianship