cyrilzakka/clinical-trials huggingface dataset:
Intestinal Akkermansia Muciniphila in Prostate Cancer

Prostate cancer has the highest incidence and is the second leading cause of cancer death in men in western countries. Androgen deprivation therapy is the backbone treatment. However, after a latency hormone sensitive prostate cancer (HSPC) usually progresses to castration-resistant prostate cancer (CRPC) requiring treatments including next generation hormonal therapies with Abiraterone Acetate (AA). This, with limited survival.

A particularly challenging area of interest to improve outcome in cancer is the interaction between the microbiome and anti-cancer therapies. Emerging data demontrate in pre-clincal studies that prostate cancer alters the microbiota, with loss of diversity and depletion of beneficial bacteria including A. muciniphila. In the other hand, Androgen deprivation therapy, reverses these effects. Specifically, in advanced disease with castration-resistant prostate cancer (CRPC), it has been shown in small studies that Abiraterone Acetate, can modulate patient-associated gastro-intestinal microbiota through promoting the growth of A. muciniphila.

The goal of our study is to confirm that AA could promote fecal Akkermansia muciniphila growth and to use the enrichment of fecal Akkermansia muciniphila as a minimally invasive biomarker of response to AA in first line metastatic CRPC.


Eligibility Criteria:
Inclusion Criteria:

* Be willing and not opposed to the study
* Be ≥ 18 years of age at the time of inclusion.
* Histologically or cytologically documented adenocarcinoma of the prostate.
* Have metastatic castration-resistant prostate cancer with castrate-level testosterone (\<50 ng/dL) during the study
* Initiation of abiraterone acetate therapy or any other next-generation hormonal therapies within 15 days after inclusion
* Participants must be able and willing to comply with the study visit schedule and study procedures
* Affiliated with French social security

Exclusion Criteria:

* CRPC patients who were previously treated with any next generation hormonal therapies in a metastatic CRPC setting
* Person under legal protection
* Inability to obtain the non-opposition
Multi-centre Study to Assess Long-term Safety and Efficacy of the Silent™ Hip Prosthesis in Primary THR

The purpose of this study is to determine if the Silent™ hip is effective in the treatment of patients with hip joint disease requiring a total hip replacement. Patients who enter the study will be evaluated at regular intervals following hip surgery using patient, clinical and x-ray assessments. A subset of patients will undergo scans to allow the bone mineral density of the bone surrounding the implant to be monitored

The purpose of this study is to determine if the Silent™ hip, when used as part of an artificial hip joint, is effective in the treatment of patients with hip joint disease requiring a total hip replacement. Patients who enter the study will be evaluated at regular intervals following hip surgery using patient, clinical and x-ray assessments. A subset of patients will undergo scans to allow the bone mineral density of the bone surrounding the implant to be monitored

Eligibility Criteria:
Inclusion Criteria:

* Male or female subjects, aged 18 years or above at the point of screening for participation.
* Subjects who are able to give voluntary, written informed consent to participate in this clinical investigation and from whom consent has been obtained.
* Subjects who, in the opinion of the Clinical Investigator, are able to understand this clinical investigation, co-operate with the investigational procedures and are willing to return to the hospital for all the required post-treatment follow-ups.
* Subjects with non-inflammatory osteoarthritis of the hip who require a primary total hip replacement and are considered suitable for a cementless femoral and acetabular component.

Exclusion Criteria:

* Subjects who, in the opinion of the Investigator, have an existing condition that would compromise their participation and follow-up in this study.
* Women who are pregnant.
* Subjects who are known drug or alcohol abusers or with psychological disorders that could affect follow-up care or treatment outcomes.
* Subjects who have participated in a clinical study with an investigational product in the last 6 months. This exclusion does not apply to those subjects who are participating in the pilot investigation of the DePuy Silent Hip (CT01/27)
* Subjects who are currently involved in any injury litigation claims.
* Subjects who have osteonecrosis of the femoral neck
* Subjects with significant bone loss or gross deformity in the region of the neck of the femur as identified on the pre-operative radiographs, where in the Investigator's opinion, there could be considerable migration of the DePuy Silent Hip or a significant chance of fracture of the femoral shaft and/or the lack of adequate bone to support the DePuy Silent Hip.
* Subjects with a Charnley C classification.
* Subjects with an active local or systemic infection.
* Subjects with loss of musculature, neuromuscular compromise or vascular deficiency in the affected limb rendering the arthroplasty procedure unjustified.
* Subjects with Paget's disease
Study of CAR-T Cell Therapy in the Treatment of Relapsed/Refractory Hematological Malignancies

The primary purpose of this study is to determine the safety and efficacy of novel autologous CAR-T cells in patients with relapsed/refractory hematological malignancies.

CAR-T cells targeted CD19 have demonstrated unprecedented successes. Besides CD19, many other molecules such as CD123, BCMA, and CD7 may be potential in developing the corresponding CAR-T cells to treat patients with hematopoietic and lymphoid malignancies. UTC Therapeutics Inc. have developed an efficient platform for constructing CAR-T cells that can remodel of tumor microenvironment and enhance the anti-tumor immune response and persistence of CAR-T cells. In this study, all eligible subjects will receive a conditioning chemotherapy regimen of fludarabine and cyclophosphamide followed by investigational treatment, CAR-T cells. Safety and efficacy of the CAR-T cells will be assessed.

Eligibility Criteria:
Inclusion Criteria:

1. Histological diagnosis of hematological malignancies (such as lymphoma, myeloma, leukemia) refractory to, or relapsing after standard therapy.
2. Positive expression of specific antigens.
3. Eastern Cooperative Oncology Group (ECOG) performance status of 0\~2.
4. Adequate organ functions:

   * Serum bilirubin ≤ 35 μmol/L;
   * Serum aspartate aminotransferase (AST)/alanine aminotransferase (ALT) \< 2;
   * Serum creatinine (Cr) ≤ 2 × upper limit of normal (ULN);
   * Brain natriuretic peptide (BNP)\<80 pg/mL.
5. Subjects must be able to understand the protocol and be willing to enroll the study, sign the informed consent, and be able to comply with the study and follow-up procedures.

Exclusion Criteria:

1. History of allergy to any of the drugs involved in the protocol.
2. History of cardiac diseases:

   * Left ventricular ejection fraction (LVEF) \< 50%;
   * Class III or IV heart failure as defined by the New York Heart Association (NYHA).
3. History of another malignancy tumor.
4. Active hepatitis C (HCV), hepatitis B (HBV), human immunodeficiency virus (HIV), or syphilis infection.
5. Patients with any contraindications to allogeneic hematopoietic stem cell transplantation.
6. Uncontrolled fungal, bacterial, viral, or other infection.
7. Female subjects who are pregnant or lactating.
Anti-Müllerian Hormone is Not Predictive of Pregnancy in Donor Insemination Cycles in Non-infertile Women

To evaluate if ovarian reserve (measured by means of anti-mullerian hormone -AMH- and antral follicle count -AFC-) can predict pregnancy in donor insemination cycles (dIUI) performed in non-infertile women.


Eligibility Criteria:
Inclusion Criteria:

* absence of male partner
* complete azoospermia or the presence of a genetic condition in the partner that made the couple opt for donor sperm
* absence of previous history of infertility.
* d ta on AMH and AFC assessment before the first dIUI cycle.

Exclusion Criteria:

* previous history of infertility.
* Presence of any gynaecological condition that could impair the inseminations results:

  * endometriosis, hydrosalpinx,...
Statins and CPAP in Adipose Tissue of OSA

This study is aimed at examining the alterations in adipose tissue in obstructive sleep apnea (OSA) patients in response to treatment with atorvastatin in continuation with standard treatment with continuous positive airway pressure (CPAP).

In recent years the role adipose tissue to the development of cardiometabolic disorders has been increasingly recognized. Dysfunctional adipose tissue is an important source for systemic inflammation, AngII, and FFA, thus increasing CV risk in obese and aging populations. Even though heightened cardiovascular risk in OSA patients is acknowledged, adipose tissue from OSA patients has not been investigated.

CPAP is standard therapy for OSA, but has shown mixed results for improvement of vascular function, insulin sensitivity, and BP, and does not reduce CV events and mortality, even in patients with established CV disease. Hence, eliminating IH alone may not be sufficient to repair preexisting damage; additional adjunct strategies aimed at cellular repair may be required to reduce cardiometabolic burden and CV risk. Statins have pleiotropic effects including reducing inflammation, and improving BP. The aim of this study is to examine the longitudinal changes in the cellular and molecular composition of adipose tissue in OSA subjects in response to 6 months combination therapy of CPAP and atorvastatin. We hypothesize that the combination therapy will reduce adipose tissue cellular damage (p16INK4A+γ-H2AX dual positive cells). Also, decreases in adipose tissue cellular damage will be associated with improved cardiometabolic profile. These studies will provide pivotal insights into potential therapeutic strategies which may reduce cardiometabolic burden in OSA population.

Eligibility Criteria:
Inclusion Criteria

* Participated in IRB 17-003825
* Apnea hypopnea index, AHI/RDI ≥10, or AHI/RDI \>5 with significant nocturnal hypoxemia documented by a fall in oxygen saturation to 90% or below.
* Women of child-bearing age will be allowed to participate if they agree to use acceptable birth control during the study period.
* TSH levels in range of 0.3-6 mIU/L (TSH above 6 mIU/L will be allowed if free thyroxine (free T4) is within normal range)

Exclusion Criteria

* Elevated ALT (\>3 times upper normal limit)
* Fasting glucose \>120 mg/dL and/or HbA1c ≥ 6.5 %
* Females planning to be pregnant in next six months will not be included in the study
* Known serious or hypersensitivity to HMG-CoA reductase inhibitors.
* Alcohol consumption \>3 units/day
Stress and Immunity Breast Cancer Project

An investigative study of the effectiveness of the BioBehavioral Intervention on Stage II/III breast cancer patients. A total of 231 patients were split between an assessment-only control group and an experimental group receiving the Intervention and assessment. The goal of the Intervention is to use psychological, behavioral, and biologic methods with the primary goal of reducing cancer recurrence.


Eligibility Criteria:
Inclusion Criteria:

* Stage II or III breast cancer diagnosis prior to adjuvant therapy

Exclusion Criteria:

-
Hospitalizations During Pandemia in the Italian Coronary Care Unit Network

Multicentre, national, observational, retrospective and prospective study.

The BLITZ-COVID19 study aims at describing the epidemiology of admissions to Italian Cardiology Intensive Care Units in the COVID-19 infection pandemia, the main aspects of the clinical management of inpatients, their short-term outcome, the absorption of resources related to their admission.

The BLITZ-COVID19 study, aims at describing the epidemiology of admissions to Italian Cardiology Intensive Care Units .

The study is observational, multicentre, national and involves the collection of clinical data, both retrospectively and prospectively, using a web-based system. In conducting the study, no drugs are tested, nor are diagnostic tests or non-pharmacological therapies performed other than those that each participating cardiologist decides to perform following the rules of normal clinical practice. Diagnostic procedures and pharmacological and non-pharmacological therapies habitually prescribed for cardiovascular pathologies, which are the object of hospitalization, and those used in the event of a COVID-19 infection, will be recorded in the database.

Eligibility Criteria:
Inclusion Criteria:

- All patients aged ≥18 years admitted with any diagnosis to one of the participating ICU

Exclusion Criteria:

- Refuse to signe consent
Absorbable vs Non-Absorbable Sutures for Hip Capsular Closure

The study is to prospectively compare absorbable sutures with non-absorbable sutures used for capsular repair during hip arthroscopic procedures. Major outcomes will be measured using three questionnaires ((1) International Hip Outcome Tool-12 (iHOT-12), (2) modified Harris hip score, (3) hip outcome score) in addition to the standard of care set of 9 questionnaires. The other major outcome will be any radiographic heterotrophic ossification at the 6-month follow-up time point.

1. International Hip Outcome Tool-12 is a 33-item patient-reported measure of health-related quality of life. It was designed to measure the impact of hip disease in young, active patients and to measure the effect of treatment of this disease.
2. Modified Harris hip score is composed of 8 survey questions to determine gait, functionality and pain.
3. The hip outcome score is 26 survey questions designed to asses the outcome of arthroscopic hip surgery for individuals with acetabular labral tears, including sports related questions and activities of daily living.

Standard of care questionnaires will be given at follow up clinic visits. They are the:

1. Patient Reported Outcomes Measurement Information System (PROMIS) Physical Function
2. PROMIS pain interference
3. PROMIS Global Health
4. Pain Visual Analog Scale
5. Hip Single Assessment Numeric Evaluation (SANE)
6. Modified Harris Hip Score
7. Marx Activity Scale
8. Tegner Activity Scale
9. Surgical Satisfaction

These questionnaires will be given at preoperative, 6-week, 3-month, 6-month, 1 year, 2 years and any other follow-up visits in association with surgery.

Any Radiographic images taken as standard of care (SOC) (post-operative radiographs are SOC) will be used in the study to determine Radiographic Heterotroph Ossification (HO) at 6 Months.

Eligibility Criteria:
Inclusion Criteria:

* Subjects 18 years of age and older.
* Subject requiring surgical hip arthroscopic intervention for their hip pathology

Exclusion Criteria:

* Subjects less than 18 years of age.
* Subjects with any other medical problem precluding anesthesia or surgery.
* Unable to provide informed consent.
Pulsed Radiofrequency Therapy for Hand OsteoArthritis Pain

Different types of pain may be present in patients with hand osteoarthritis, including nociceptive pain and non-nociceptive pain. This makes adequate pain treatment difficult, and thus new treatment options are needed. To this end, this trial will evaluate the effect of transcutaneous pulsed radiofrequency for the treatment of hand osteoarthritis pain.

In this randomized clinical trial, patients with hand osteoarthritis, recruited from the Leiden University Medical Center Rheumatology outpatient clinic, aged 18-80 and fulfilling hand pain criteria will be randomized to undergo trancutaneous pulsed radiofrequency therapy of the hand or a sham. The effect will be measured in change in 10 point numeric rating scale for pain in the hand over 6 weeks. This RCT will have little burdens and risk for the subjects. The proposed intervention, tPRF, is well tolerated, with no known serious side effects.

Eligibility Criteria:
Inclusion Criteria:

* Age 18-80
* Hand osteoarthritis according to the ACR criteria
* Hand pain of at least 30mm on a 100mm VAS
* Chronic hand pain

Exclusion Criteria:

* Known inflammatory rheumatic diseases
* Psoriasis
* Seropositivity for rheumatoid factor of anti-CCP antibodies
* No understanding of the Dutch language
* Fibromyalgia (Following the ACR 2011 classification criteria)
* Neurological disorders interfering with pain perception and measurements
* Carpal tunnel syndrome interfering with pain perception and measurements
* History of chemo- and/or radiotherapy
* Spinal surgery or spinal trauma with lasting complaints interfering with pain perception and measurements
* Cognitive impairment or psychiatric conditions interfering with pain perception and measurements
* Pregnancy or breast-feeding
* Eye surgery for glaucoma or keratoconus or other surgery of the cornea in the three preceding months
* Presence of an implantable cardioverter-defibrillator (ICD), neurostimulator or pacemaker
* Metal implants in the hand, arm, shoulder or neck of the side that is to be treated
DOTATATE PETMRI AAA Study

Abdominal Aortic Aneurysm (AAA) screening and an aging population have increased the prevalence of AAA diagnoses. Small AAAs (\<5.5cm) are monitored with ultrasound. Large AAAs may rupture and this is usually fatal. Surgery is considered at a crude size threshold of 5.5cm when the annual rupture risk reaches 5%. AAA size is the only predictor of growth and rupture available but growth is non-linear and some small AAAs rupture. Thus, only 1 in 20 patients treated at 5.5cm will have benefited from rupture prevention in the year following surgery, and others may miss out on life-saving surgery. This study will develop an imaging tool PETMRI with radiotracer Ga- DOTATATE with high clinical utility, to improve prediction of aneurysm growth and risk.

The prevalence of abdominal aortic aneurysm (AAA) in those over 65 years is 4-8% and rising. Currently, AAA size is the only metric to determine risk of growth/rupture; we are unable to image the underlying disease process. Using size alone is problematic. For small AAAs there is no consensus between surgical societies on appropriate surveillance intervals. AAA growth is non-linear and thus some small AAAs may rupture between screening intervals.

Macrophage mediated inflammation leads to weakening of the aortic wall. Our own laboratory work indicates macrophages correlate with AAA severity in mice. In humans, activated macrophages express SomatoSTatin Receptor 2 (SSTR2). For the first time ever, using a radiotracer probe specific for SSTR 2 (gallium-dotatate), we will detect activated macrophages in AAAs using Positron Emission Tomography- Magnetic Resonance Imaging (PET-MRI). Patients attending the University Health Network (UHN) Vascular clinic undergoing ultrasound surveillance of small AAAs of differing sizes will be imaged with Ga-Dotatate PET-MRI. We will correlate aneurysm size and anatomical information with in-vivo imaging of aortic macrophages detected with Ga-Dotatate, to determine the risk of aneurysm growth.

Eligibility Criteria:
Inclusion Criteria:

1. Diagnosis of asymptomatic abdominal aortic aneurysm AAA \>3cm in maximum diameter;
2. Minimum 2 years prior ultrasound or CT imaging of their AAA;
3. No prior treatment for AAA;
4. Age \>50 years;
5. No contraindications to PET/MRI, such as claustrophobia;

Exclusion Criteria:

1. Pregnant females. All women of child-bearing potential must receive a negative urine pregnancy test prior to administration of 68Ga-DOTATATE;
2. Allergy and/or hypersensitivity to MRI contrast agents (gadolinium) or components of 68Ga-DOTATATE drug product (as listed in IB);
3. Presence of pacemaker or implanted cardioverter defibrillator (ICD);
4. History of alcohol or substance abuse.
Fitness and Sleep in People With Family History of Type 2 Diabetes.

Currently, it is not known if the amount of nighttime sleep has any effect on the overall physical fitness, and on how much energy do people who have a relative with type 2 diabetes (parent, sibling, or grandparent) use to perform activities of daily living. This study will test the hypothesis that individual differences in nighttime sleep duration are related to differences in the amount of energy used to perform activities of daily living and the overall level of physical fitness of the individual.

The study includes 2 weeks of monitoring of the participants' patterns of sleep and wakefulness at home. At the beginning of this period, all participants will undergo measurements of their body composition (lean tissue, bone and fat) and their metabolic rate at rest and after a standard meal. At that time, all participants will also drink a glass of water containing harmless non-radioactive dense forms of oxygen and hydrogen, small amounts of which are found in natural water. Several urine samples will be collected before and after the participants drink the water at the beginning of the study and again 14 days later in order to measure the amount of energy that was used by them during this time. Participants will also wear small wristwatch-like activity monitors on their wrist and around their waist as they follow their usual everyday activities and sleep-wake schedules at home. The recordings from these monitors combined with daily sleep logs will be used to determine when the participants slept and when they were awake. On the last day of the study, the participants will undergo MRI measurements of the distribution of fat in their abdomen and complete a graded exercise test on a treadmill or stationary bicycle in order to determine what is the most strenuous level of exercise that they can perform. A medical doctor will supervise all study procedures that are done in the research laboratory.

Eligibility Criteria:
Inclusion Criteria:

* regular sleep habits
* BMI 20 to 27 kg/m2
* at least one parent, sibling or grandparent with type 2 diabetes
* no regular exercise habits

Exclusion Criteria:

* active smoker
* night or shift work
* have highly variable sleep habits
* have a hormonal disorder
* have a sleep disorder
* have an active medical problem
* for women: use of birth control pills
* for women: irregular menstrual periods or pregnancy
* use of medications/compounds that can disrupt sleep