cyrilzakka/clinical-trials huggingface dataset:
Intermittent Androgen Deprivation Therapy With or Without Stereotactic Body Radiotherapy for Molecularly Identified Hormone Sensitive Oligometastatic Prostate Cancer

This study is evaluating whether adding stereotactic radiotherapy (a new, more focused type of radiotherapy) to treat all the tumours that are present will improve outcomes or not compared to drugs alone for patients who are negative on conventional imaging and positive on PSMA PET scan


Eligibility Criteria:
Inclusion Criteria:

1. Age \> 18 years.
2. Able to provide informed consent.
3. Histologic diagnosis of prostate adenocarcinoma.
4. ECOG performance status 0-1.
5. Stage IV hormone sensitive, synchronous or metachronous oligometastatic prostate cancer as detected by PSMA PET-CT scan with no metastases visible on conventional imaging (CT chest/abdomen/pelvis and bone scan +/- MRI) performed within 3 months of starting ADT.
6. Up to a maximum of 3 PSMA avid areas of metastatic disease.
7. For patients with metachronous disease, there must be a documented PSA rise. For those who had previous prostatectomy, PSA must be \> 0.2 ng/mL. For those who had previous radical radiotherapy, PSA must have risen to at least 2 ng/mL above the nadir (Phoenix definition). The primary tumor must be controlled, with no PSMA avid progression within the primary prostate.
8. All sites of disease are amenable to and can be safely treated with SBRT.

Exclusion Criteria:

1. Significant comorbidities rendering patient not suitable for ADT and/or SBRT.
2. History of malignancy within the past 5 years, excluding non-melanoma skin cancer and in-situ cancer.
3. Prior use of salvage or palliative intent ADT. Prior ADT use allowed only if it was delivered neoadjuvantly, concurrently, or adjuvantly with curative-intent treatment to the prostate or prostate bed (for patients with metachronous presentations), and at least 12 months have elapsed.
4. Castrate resistant prostate cancer.
5. Evidence of spinal cord compression.
Functional Impact of Reconstructive Surgery by Harvesting a Vascularized Free Fibula Flap Postoperatively.

The fibula is a leg bone that can be used in complex bone reconstruction by reconstructive surgery. This innovative surgical procedure is increasingly used in complex facial (mandibular) reconstructions following cancer and trauma involving a bone segment. Following this surgery, chronic pain and post-operative complications can occur, with a functional impact on locomotion, leading to instability, ankle stiffness and a risk of falls. The causes of functional deficits following surgery remain complex and difficult to objectivate by clinical examination alone. However, these deficits need to be better evaluated to develop specific therapeutic targets that will allow the implementation of a personalized postoperative rehabilitation. At present, no study has been performed to objectively quantify the short- and medium-term functional repercussions of the operation.

This study proposes, for the first time, to quantify the repercussions on muscular and locomotor functions as well as the quality of life after reconstructive surgery by transfer of a free vascularized fibula flap in the short and medium term (1 month and 6 months postoperatively).

This is a biomedical, interventional study, which will take place on the Technological Investigation Platform (PIT) located on the garden level of the Rehabilitation Center (C2R) of the Dijon Bourgogne University Hospital, 35 participants will be included in this study over a period of 36 months. For this study, you will be followed for about 7 months, during 3 obligatory visits


Eligibility Criteria:
Inclusion Criteria:

* All patients eligible for bone reconstruction with a free fibula flap
* Age ≥ 18 years
* Procedure scheduled in the plastic and maxillofacial surgery department of the Dijon University Hospital
* Willingness to comply with the protocol requirements
* Person having given oral, free and informed consent

Exclusion Criteria:

* Person who is not affiliated or not a beneficiary of a social security system
* Person subject to a legal protection measure (curatorship, guardianship)
* Person subject to a legal protection measure
* Pregnant, parturient or breastfeeding woman
* Major who is incapable or unable to give oral consent
* Minor
* Indication for bone reconstruction of a lower limb (e.g. femur) or pelvis
* Musculoskeletal or neurological disorders causing significant prior impairment of walking (whatever the etiology)
* Cognitive disorders that prevent the proper understanding of instructions and the completion of questionnaires
* Non operated patient
Chocolate Balloon Angioplasty Registry

To collect data from real-world use with the Chocolate PTA Balloon Catheter to support the effectiveness of the device for use during percutaneous transluminal angioplasty (PTA) procedures.


Eligibility Criteria:
Inclusion Criteria:

1. \>18 years of age
2. Lesion successfully crossed with a guide-wire
3. Reference Vessel Diameter (RVD) within the treatment range of the Chocolate PTA Catheter used at the target lesion appropriate for 1:1 dilatation
4. Patient has given consent for their information to be submitted to this registry

Exclusion Criteria:

1. Lesion required stenting as the primary treatment approach
2. Life expectancy \<12 months
3. Patient is enrolled in another clinical study that may impact the results of this registry
Advanced Sensor Based Functional ASsessmenTs in Axial Spondyloarthritis

This is an observational study using Inertial Measurement Unit (IMU) sensors to measure the effects of biological therapy on spinal mobility and function in axial spondyloarthritis. Participants will undergo MRI scans before and after therapy in parallel to the sensor tests to establish correlation between changes in inflammatory signs and changes in spinal mobility.

We will study 20 participants with active axial spondyloarthritis (axSpA) who are about to start biologic therapy as part of routine care. In brief, we will carry out the following assessments before and after therapy:

1. MRI of spine and Sacroiliac (SI) joints - modified Stoke Ankylosing Spondylitis Spine Score (mSASSS) scoring
2. Record standard Patient recorded outcomes (PROs): Bath Ankylosing Spondylitis Disease Activity Index (BASDAI), Bath Ankylosing Global (BASG), Bath Ankylosing Spondylitis Metrology Index (BASMI), Bath Ankylosing Spondylitis Functional Index (BASFI), Ankylosing Spondylitis Disease Activity Score (ASDAS), Ankylosing Spondylitis Disease Activity Score Health Index (ASAS-HI), Euroquol 3 level health assessment (EQ5D-3L), work productivity and activity impairment questionnaire (WPAI), Short QUestionnaire to ASsess Health enhancing physical activity (SQUASH),
3. Erythrocyte sedimentation rate (ESR), C-reactive protein (CRP)
4. IMU sensor tests in clinic for range of motion (ROM) in cervical, thoracic and lumbar spine.
5. IMU sensor tests at home for standardised function testing

Eligibility Criteria:
Inclusion Criteria:

1. Diagnosis of axial spondyloarthritis fulfilling ASAS classification criteria.
2. Age ≥18 years old and \<80 years.
3. Fulfilment of local criteria for biologic therapy for axSpA.
4. The subjects should be able to read, write, understand and complete study questionnaires.
5. Each subject must sign an informed consent form (ICF) indicating that he or she understands the purpose of and procedures required for the study and are willing to participate in the study.

Exclusion Criteria:

1. Safety contra-indication for biologic drug therapy.
2. Severely restricted hip movement (less than 20 degrees rotation in either hip).
3. History of previous clinical (symptomatic) vertebral fracture.
4. History of previous spinal surgery.
5. History of previous hip replacement surgery.
6. Major scoliosis deformity (in the opinion of the investigator).
7. Safety contra-indication for MRI assessment.
8. Previous biologic agent within 2 months.
9. Pregnant or breast-feeding women.
The Role of Carotid Flow Time-Based Fluid Administration in Caesarean Section

It has been reported that corrected carotid flow time (FTc) may indicate the responsiveness of spontaneously breathing patients to fluid therapy. The primary objective of the study is to determine the effect of fluid preload applied to patients with preanesthetic FTc values below the cut-off value on the incidence of hypotension in cesarean section (C/S) surgery. Pregnant women who underwent cesarean section under spinal anesthesia were included in this prospective study. In the preoperative care unit, patients were assigned to two groups according to their baseline FTc values. Patients with baseline FTc \< 327 ms were assigned to the first group, and Ringer Lactate (RL) preload fluid administration to these patients was continued until FTc \> 327 ms. On the other hand, patients with baseline FTc \> 327 ms were assigned to the second group, and preload fluid was not administered to these patients. Intraoperative hemodynamic data were recorded for each patient.


Eligibility Criteria:
Inclusion Criteria:

* 20-40 years of age pregnant women
* American Society of Anesthesiologists (ASA) physical status-II patients
* Uncomplicated, singleton, term pregnancy
* Elective C/S surgery

Exclusion Criteria:

* Placental disorders
* Gestational hypertensive disorders
* Morbid obesity (BMI\>39 kg/m2)
* Carotid stenosis more than 50%
* Baseline SAP more than 160 mmHg
* Arrhythmia
* History of cardiovascular or cerebrovascular disease, and chronic kidney disease (estimated glomerular filtration rate \<60 mL/min/1.73 m2)
* Emergency surgery
Clinical Pilates Exercises On Posture In Patients With Shoulder-Neck Posture Problem

This study was designed to investigate the effect of clinic pilates exercise in adult patients whith shoulder- neck posture problem. 51 patients with forward head posture(FHP) and rounded shoulder posture(RSP) were included in this study and they were randomly divided into two groups as clinical pilates (group 1, n=26) and classical posture exercises (group 2, n=25). Patients' demographics were recorded. Deep neck fleksor muscle(DNFM) endurance was evaluated by pressure biofeedback unit (PBU). Head, neck and shoulder posture were evaluated with wall- tragus, wall-acromion, tragus-acromion and chin-sternal notch distance. Flexibility for shoulder region was evaluated with back scratch test. The patients were evaluated both before the study and 6 weeks later.

Fifty-one individuals aged between 20-55 years whose FHP and RSP problems were determined by lateral posture analysis were included in the study. However, a total of 12 individuals, 6 from each of the 2 groups, were excluded from the study because they could not complete the treatment sessions. The study was completed with 39 participants.Individuals aged between 20-60 years, whose FHP and RSP problems were determined by lateral posture analysis, were included in the study. Those with severe pain in the neck and shoulder girdle, scoliosis and neurological problems and those who had undergone any surgery in the relevant regions were not included in the study. The individuals included in the study were randomized by lot and divided into 2 groups. Group 1 was given clinical pilates exercises, and Group 2 was given a program consisting of classical posture exercises. The exercise programs of both groups were performed by the same physiotherapist, and pre- and post-exercise evaluations were made by a different physiotherapist.

Eligibility Criteria:
Inclusion Criteria:

* FHP and RSP problems were determined by lateral posture analysis

Exclusion Criteria:

* skoliosis
Effect Baroreflex Activation Therapy on the Carotid Body

Carotid baroreflex activation therapy (BAT) by the Rheos® system produces a sustained fall in blood pressure in patients with resistant hypertension. Since the activation electrodes are implanted at the level of the carotid sinus, it is conceivable that the nearby located carotid body chemoreceptors are stimulated as well. Physiological stimulation of carotid chemoreceptors not only raises respiration, but it also increases sympathetic activity which may in part counteract the effects of BAT. The aim of the present study is to investigate whether there is evidence for concomitant carotid chemoreflex activation during BAT. We hypothesized that there is no clinically relevant co-activation of the carotid body chemoreceptors during BAT in patients with resistant hypertension.


Eligibility Criteria:
Inclusion Criteria:

* Be currently implanted with Rheos system and have completed the 13-month follow-up period.
* Be on stable anti-hypertensive therapy for at least 4 weeks prior to inclusion, where stable is defined as no changes in medications or dosage of medications.
* Have at least one functional carotid baroreflex activation electrode.
* Have signed and approved informed consent form for participation in this study.

Exclusion Criteria:

* Myocardial infarction (MI) or cerebral vascular accident (CVA) within the past 90 days, or subject is still unstable from a prior MI or CVA that occurred more than 90 days ago.
* Are unable or unwilling to comply with the protocol requirements of this study.
* Diagnosed with severe chronic obstructive lung disease (COPD/asthma GOLD stadium III and IV).
Resveratrol in Patients With Non-alcoholic Fatty Liver Disease

Non-alcoholic fatty liver disease (NAFLD) and fatty liver hepatitis (NASH) are very common in the Western world and strongly associated with obesity. No known effective treatment is known. From animal studies, it is known that the compound resveratrol perhaps has the potential to neutralize obesity-induced diseases. Resveratrol is already widely used as a food supplement though the precise effects are unknown. This project focuses on the effect of Resveratrol on fatty liver disease. The researchers plan to investigate the effects of Resveratrol or placebo treatment for 6 months on NAFLD/NASH in obese patients.

Obesity is associated with non-alcoholic fatty liver disease (NAFLD) and steatohepatitis (NASH) and recently, low-grade inflammation has been hypothesized to be the causative link. From animal studies, it is known that the compound resveratrol (RES) has strong anti-inflammatory and antioxidant effects and perhaps the potential to neutralize obesity-induced diseases. RES is already widely used as a food supplement though the precise effects are unknown. This project focuses on the effect of RES on fatty liver disease. In a double-blind controlled clinical trial, the researchers investigate the effects of RES 500 mg or placebo treatment x 3 daily for 6 months on NAFLD/NASH in 48 obese patients in a double-blind, randomised, controlled clinical trial. The researchers hypothesize that RES improves the ALT levels and reduces liver fat and inflammation assessed by MR spectroscopy and histological evaluation.

Eligibility Criteria:
Inclusion Criteria:

* ALT ≥70 U/L for men and ≥45 U/L for women
* steatosis of the liver, assessed by ultrasonography
* one of the following:

  * waist circumference ≥102 cm for men and ≥88 for women
  * hypertension: BP ≥130/80 mmHg
  * raised triglycerides ≥1,7 mmol/L
  * reduced HDL cholesterol ≤1.0 mmol/L
* BMI ≥ 25 kg/m²

Exclusion Criteria:

* weight \> 130 kg
* comorbidity such as diabetes, cancer, metabolic or coagulation disorder, or significant liver-, heart- or kidney disease
* MRI contraindication
* treatment with glucocorticoids or methotrexate
* alcohol intake \>20g/daily for men and \>12 for women
Optical Coherence Pachymetry to Evaluate Central Corneal Ablation Depth in Myopic Femtosecond Laser in Situ Keratomileusis

Prospective study aiming to measure central ablation depth during excimer laser surgery in myopic patients operated with femtosecond laser assisted LASIK with intraoperative OCP, before and after laser ablation. This measurement will be compared with pre and 1 month postoperative topography differential pachymetric measurements.


Eligibility Criteria:
Inclusion Criteria:

* Patients over 18 years old
* undergoing refractive surgery with LASIK
* with myopic or compound myopic astigmatism ametropia
* without irregular cornea and topographical sign of keratoconus
* preoperative corneal thickness compatible with LASIK

Exclusion Criteria:

* hyperopia
* opposition to participate in the study
* no health insurance coverage
* patient under legal protection
* pregnant or breastfeeding patient
Post-Market Study of the EPIK Knee System

The purpose of this study is to determine the short-term (2 yr) and midterm (5 yr) cumulative revision rates of the EPIK™ Uni-compartmental Knee System.

Medial uni-compartmental knee replacement (UKA) has been used for over 40 years to treat osteoarthritis (OA) of the knee. It is becoming more widely accepted as a treatment for early stage OA of the knee in order to preserve bony and ligamentous structures. The majority of the subjects who have received this knee are older (over 65 yrs) however, it is being used increasingly more frequently in younger individuals who have uni-compartmental knee disease so that bone may be spared in case the need arises in the future for a total knee arthroplasty. The study will take place at two sites within the United States and be managed by the Clinical Affairs Department at DJO Surgical in Austin, TX. The study will include only subjects who meet the indications for use criteria for the EPIK™ Uni-compartmental Knee System and who are candidates for UKA. Investigators will enroll up to 60 subjects at each of 2 sites within the United States, for a total of 100 subjects maximum.

Eligibility Criteria:
Inclusion Criteria:

* Meet the indications for use of the EPIK Uni-compartmental knee system
* Must be a primary surgery
* Have a primary diagnosis of OA in the medial knee compartment
* Have active and passive flexion \> 90º
* Have a fixed flexion contracture \< 10º
* Have an intact ACL and PCL
* Be a primary, unilateral surgery
* Have BMI ≤ 35.00
* Must not have infection (or history of infection within last 3 months), chronic or acute, local or systemic
* Must not be pregnant
* Be willing and able to sign the informed consent
* Be willing to follow study procedures, including all follow up visits
* Be over 18 years of age (≥ 18) and 60 years or younger (≤ 60) at time of consent

Exclusion Criteria:

* Prior total or uni-knee arthroplasty (must be a primary surgery)
* Patello-femoral joint symptoms
* Bilateral surgical procedures
* BMI \> 35.00
* Muscular, neurological or vascular deficiencies which compromise the affected extremity
* Insufficient bone quality which may affect the stability of the implant
* Infection (or history of infection within last 3 months), chronic or acute, local or systemic
* Is younger than 18 years of age (\<18) or over 60 (\>60) years of age
* Mental conditions that may interfere with the subject's ability to give an informed consent or willingness to fulfill the study requirements
* High levels of physical activity (ex. Competitive sports, heavy physical labor)
* Documented (active) alcohol or drug addictions
* Loss of ligamentous structures
* Prisoner
* Metals sensitivity
* Subject is pregnant
A Postmarketing Study of Lecanemab in South Korean Participants With Alzheimer's Disease

The primary purpose of this study is to evaluate safety of lecanemab in the real-world clinical setting as reported by events of amyloid-related imaging abnormalities (ARIA)-edema (ARIA-E), ARIA-hemosiderin deposition (ARIA-H), symptomatic ARIA-E, symptomatic ARIA-H, and intracerebral hemorrhage (ICH) greater-than 1 centimeter (cm) in participants treated with lecanemab.


Eligibility Criteria:
Inclusion Criteria:

* 18 years or older at consent
* Prior to JOY-ALZ enrollment, the treating physician confirms that the participant is suitable for lecanemab treatment, as per the approved indications in South Korea
* Has an identified study partner who provides separate written informed consent
* Provides written informed consent for the use of medical information to be shared with Eisai Korea Inc.

Exclusion Criteria:

* Currently participating in an interventional clinical study
* Has contraindications for lecanemab according to the approved prescribing information in South Korea
A Placebo and Active Controlled Study of ONO-6950 in Asthmatic Patients

The primary objectives of this study are:

i. to determine the effect of single oral doses (20 and 200 mg) of ONO-6950 versus placebo on exercise induced bronchoconstriction (EIB) as percent attenuation in the decrease of forced expiratory volume in 1 second (FEV1) after exercise challenge

ii. to determine the safety and tolerability of single dose administrations of 20 and 200 mg of ONO-6950 in asthmatic patients.

The secondary objectives of this study are:

i. to compare the effect of different (20 and 200 mg) single oral doses of ONO-6950 versus montelukast (10 mg) on EIB as percent attenuation in the decrease of FEV1 after exercise challenge

ii. to determine the ratio of responders/non-responders in FEV1 for different (20 and 200 mg) single oral doses of ONO-6950 in comparison to montelukast (10 mg) and placebo.

The study will examine if ONO-6950 could alleviate EIB in asthmatic patients. Eligible patients will complete a randomized, double-blind, four-way crossover study. During each of four evaluation periods, patients will be administered a single dose of either 20 or 200 mg ONO-6950, 10 mg Montelukast, or placebo. Each evaluation period include various assessments following exercise challenge in an ambulatory setting.

Eligibility Criteria:
Inclusion Criteria:

* Patients of both genders, between 18 to 60 years of age, with bronchial asthma for at least 6 months and history of exercise induced bronchospasm
* Patients with FEV1 ≥ 70% of predicted after withholding short-acting β agonists for at least 8 hours prior to testing
* Screening exercise challenge demonstrates that the patient experiences a fall in FEV1 of ≥ 20%
* Non-smokers with free from the usage of nicotine-containing products at least for a year prior to screening

Exclusion Criteria:

* Previous history of life-threatening asthma, respiratory tract infection and/or exacerbation of asthma within 6 weeks prior to the first screening visit
* History of being unable to tolerate or complete an exercise challenge and clinically significant multiple drug or food allergies
* Past or present disorders and diseases including, but are not limited to cardiovascular, malignancy, hepatic, renal, hematological, neurological, psychiatric, endocrine, or pulmonary other than asthma
* Patients with Seasonal Allergic Rhinitis (SAR) or seasonal allergic asthma,with significant symptoms that may confound study assessment
* Significant safety laboratory, ECG, or vital sign abnormalities that would place the patient at undue risk during the study procedures