cyrilzakka/clinical-trials huggingface dataset:
Clinical and Histological Evaluation of the Picosure 755nm Laser With Cap Array for Facial Rejuvenation

The purpose of this study is to assess treatment of facial rejuvenation using the standard hand piece and a Lens Array for the 755nm Alexandrite laser.


Eligibility Criteria:
Inclusion Criteria:

1. Is a healthy male or female between 18 and 65 years old
2. Is willing to consent to participate in the study.
3. Is willing to comply with all requirements of the study including biopsies, being photographed, following post treatment care and attending all treatment and follow up visits.

Exclusion Criteria:

1. The subject is female and pregnant, has been pregnant within the last 3 months, is currently breast feeding or planning a pregnancy during the study period.
2. The subject is hypersensitive to light exposure OR takes photo sensitized medication.
3. The subject has active or localized systemic infections.
4. The subject has a coagulation disorder or is currently using anti-coagulation medication (including but not limited to heavy aspirin therapy {greater than 81 mg per day}).
5. The subject has any condition which, in the investigator's opinion, would make it unsafe for the subject to participate in this research study.
6. The subject is currently enrolled in an investigational drug or device trial, or has received an investigational drug or been treated with an investigational device within 3 months prior to entering this study.
7. The subject has used Accutane within 6 months prior to enrollment.
8. The subject has the need to be exposed to artificial tanning devices or excessive sunlight during the trial.
9. The subject has had prior treatment with parenteral gold therapy (gold sodium thiomalate).
10. The subject has a history of keloids.
11. The subject has evidence of compromised wound healing.
12. The subject has a history of squamous cell carcinoma or melanoma.
13. The subject has a history of immunosuppression/immune deficiency disorders (including HIV infection or AIDS) or use of immunosuppressive medications.
14. The subject has an allergy to lidocaine and epinephrine.
IMU-935 in Patients With Progressive, Metastatic Castration Resistant Prostate Cancer

Dose escalation study to evaluate the safety, tolerability and anti-tumor activity of single agent IMU-935 in patients with progressive, metastatic castration resistant prostate cancer (mCRPC).

This is an open-label, non-randomized Phase 1 dose escalation, followed by dose expansion, study to define the safety, tolerability, biomarker change and anti-tumor activity of IMU-935 in patients with mCRPC. Throughout the study, safety, anti-tumor activity, biomarkers and IMU-935 plasma concentrations will be evaluated at regular intervals as per schedule of assessments. Disease progression will be assessed as per standard medical practice.

The dose escalation and expansion parts of the study will have the same treatment duration with similarly structured treatment cycles.

The study will consist of the following periods:

* Screening Period: Approximately 28 days
* Treatment Phase:

Main treatment over 3 cycles of 28 days each, extended treatment as long as patient benefits

Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 years
* Male patients with histologically or cytologically confirmed adenocarcinoma of the prostate with no evidence of small cell or neuroendocrine features
* Metastatic disease with limited therapeutic options, prior treatment with at least one next-generation hormonal agent (e.g., abiraterone, enzalutamide, apalutamide, darolutamide) and one taxane line of treatment is allowed
* Progressive disease is defined as rising prostate-specific antigen (PSA) levels ≥2ng/mL and/or radiographic progression according to Prostate Cancer Working Group 3 (PCWG3) criteria at screening
* Able and willing to comply with all study requirements for the duration of the study
* Patients must sign an ICF prior to the start of any study-related procedures

Exclusion Criteria:

* Anti-tumor therapy (chemotherapy, antibody therapy, molecular targeted therapy) within 28 days prior to starting study treatment
* Uncontrolled intercurrent illness such as active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, uncontrolled hypertension, or psychiatric illness/social situations that would limit compliance with the study protocol
* Malignancy within the previous 2 years with a ≥30% probability of recurrence within 12 months, with the exception of non-melanoma skin cancer or superficial bladder cancer
* Patients receiving strong inhibitors or inducers of cytochrome P450 (CYP) 3A4
* Chronic use of systemic steroid therapy (\>1 month of \>10 mg prednisone per day or equivalent, except replacement therapy)
* Patients for whom biopsies cannot be taken or are not willing to undergo biopsies
* Positive hepatitis B virus (HBV) surface antigen, hepatitis B core antibody, positive hepatitis C virus (HCV) antibody, and/or HIV-antigen-antibody test at screening
Bioavailability of Pea Protein in Young and Old Volunteers

The aim of this study done in healthy, non-malnourished young and elderly subjects, is to measure the bioavailability of protein intake and the variation of metabolic markers following consumption of pea protein " NUTRALYS ® S85 plus" or a reference protein brought in water either alone or at the end of a standardized meal.


Eligibility Criteria:
Inclusion Criteria:

* Adult male volunteers, aged over 65 or under 30
* Body mass index (weight in kg/ height² in m²) between 22 and 28 kg/m²,
* Subjects considered to be healthy by the principal investigator doctor according to the interview, medical and clinical examination,
* Biological assessment considered compatible with participation in the study,
* Persons able to sign the informed consent,
* Persons affiliated to social security scheme.

Exclusion Criteria:

* Pathologies or treatments not compatible with the study
* Food allergy or a contraindication to the consumption of the products tested
* Subject in a situation which, in the opinion of the investigator, could interfere with their optimal participation in the study or constitute a particular risk for the subject,
* Subject with a particular diet (vegetarians, vegans, nutritional supplements, etc.),
* Subject weighing \< 55 kg,
Evaluation of Root Coverage After the Use of Coronally Advanced Flap Either With Advanced Paltelet Rich Fibrin or Subepithilial Connective Tissue Graft in Treatment of Miller Class I and II Gingival Recession.

patients with Miller class I , II gingival recession will be divided into 2 groups (control, intervention).the control one will receive coronally advanced flap with subepithililal connective tissue graft harvested from the palate while the intervention one will have coronally advanced flap with advanced platelet rich fibrin(A-PRF).as it represent a new generation of platelet concentrate allow for better healing and root coverage results.

Null hypothesis: In patients with Miller class I and II gingival recession, there is no difference in amount of root coverage (mm) following the application of SCTG+A-PRF compared to CAF+SCTG.

* Population (P): Patients with single Miller class I, II gingival recessions.
* Intervention (I): Coronally advanced flap (CAF) plus platelet rich fibrin (A-PRF).
* Comparator (C): Coronally advanced flap (CAF) plus subepithelial connective tissue graft (SCTG).
* Primary Outcome (O): Root coverage (mm).
* Time frame: 9 months.
* Study design: Randomized controlled clinical trial.
* Patients are to be selected from the outpatient clinic of the department of Oral Medicine and Periodontology-Cairo University

Eligibility Criteria:
Inclusion Criteria:

* Systemically healthy patients 18 years old and older both males and females.
* Good oral hygiene after phase I therapy.
* Miller's class I or II gingival recession.
* Not using antibiotics, steroids, chemotherapy or other medications that may modify results of the surgery and healing.
* Cooperative patients able and accept to come for follow up appointments

Exclusion Criteria:

* Pregnant or lactating females.
* Current Smokers.
* Patients with any systemic disease that may affect the periodontal healing.
* Teeth with endodontic treatment, buccal restoration or caries.
* Patients with poor oral hygiene
Nebulized Versus Intravenous Dexmedetomidine for Sevoflurane Induced Emergence Agitation After Pediatric Tonsillectomy

Pediatric patients undergoing tonsillectomy and adenoidectomy usually have a high incidence of postoperative EA, which increases the risk of developing postoperative airway obstruction and respiratory depression due to anatomical characteristics of operative location and increased susceptibility to opioid analgesics. the study will compare between nebulized and intravenous bolus of dexmedetomidine as a prophylaxis against postanesthetic emergence agitation in children undergoing tonsillectomy, adenoidectomy or adeno-tonsillectomy procedures.


Eligibility Criteria:
Inclusion Criteria:

* ASA I and II
* Children scheduled for tonsillectomy with or without adenoidectomy with or without myringotomy, and/or tympanostomy tube insertion.

Exclusion Criteria:

* Patient's guardian refusal to participate in the study.
* Children with Behavioral changes; physical or developmental delay; neurological disorder or psychological disorder.
* Children on sedative or anticonvulsant medication.
* history of sleep apnea
* significant organ dysfunction, cardiac dysrhythmia, congenital heart disease
* Known allergy to the study drugs.
Psychosocial Outcomes and Transition Readiness in JIA

It is widely acknowledged that the transition from paediatric to adult health services should be a multidimensional and multidisciplinary process that addresses the medical, psychosocial, and educational needs of adolescents and young adults (AYA). Despite this, there is currently a scarcity of research examining the relationships between psychosocial factors (e.g., anxiety, social support) and transition readiness in AYA with juvenile idiopathic arthritis (JIA). This study therefore aimed to examine the relationships between psychosocial factors and transition readiness in pre-transfer adolescents and post-transfer young adults aged 10-25 years diagnosed with JIA at a single centre.

In total, 40 adolescents aged 10-16 years together with a parent/guardian, will take part at Sheffield Children's Hospital and 40 young adults aged 16-25 years will take part at Sheffield Teaching Hospitals. Participants will be asked to complete a battery of self-report questionnaire measuring psychosocial factors (anxiety/depression, social support, family functioning, health-related quality of life) and transition readiness (transition knowledge and skills, self-efficacy). JIA disease severity was also measured during clinic appointments. This study has received full ethical approval, and all participants will give their written informed assent or consent before taking part.

The results from this research will be important in better understanding which psychosocial factors affect how ready young people with JIA feel to move from paediatric to adult rheumatology services. We hope this research will inform further work to help target psychological interventions in this group of patients.


Eligibility Criteria:
Patient Inclusion Criteria:

* Aged 10-25 years
* Diagnosis of juvenile idiopathic arthritis (including all ILAR subtypes except 'systemic arthritis' and 'undifferentiated arthritis')
* Juvenile idiopathic arthritis managed by Sheffield Children's Hospital or Sheffield Teaching Hospitals
* Fluent in verbal and written English

Patient Exclusion Criteria:

* Aged \<10 years or \>25 years
* Diagnosis of juvenile idiopathic arthritis ILAR subtypes 'systemic arthritis' or 'undifferentiated arthritis')
* Diagnosis of uveitis
* Non-fluent in verbal and written English
The Italian Coronary Artery Aneurysm and Ectasia In Patients With Acute Coronary Syndrome

The ITACA study is a prospective, observational no profit registry enrolling patients with Acute Coronary Syndrome and angiographic evidence of coronary aneurysms and/or ectasia.

The ITACA study is aimed at evaluating short and long term outcomes in patients with acute coronary sindrome and angiographic evidence of coronary aneurysm and/or actasia. Data regarding safety and effectiveness of invasive and pharmacological treatment strategies will be also collected.

Eligibility Criteria:
Inclusion Criteria:

* Signature of informed consent;
* Patients aged ≥18 years;
* diagnosis of ACS (ST-elevation myocardial infarction, non ST-elevation myocardial infarction, unstable angina), in accordance with the definition provided in the latest guidelines;
* diagnosis of ectasia or coronary aneurysm according to the definitions contained in this protocol, either in the culprit vessel of the SCA than in another vessel. Coronary pseudoaneurysms are excluded.

Exclusion Criteria:

* impossibility or unwillingness to provide signed informed consent;
* contraindications to dual antiplatelet therapy;
* contraindications to anticoagulant therapy;
* active bleeding or severe anemia (Hb \<6 g / dl);
* life expectancy \<12 months;
* female patients with potential pregnancy;
Safety And Efficacy Of Rescriptor In Patients For Human Immunodeficiency Virus (HIV) Patients

The objective of this surveillance is to collect information about 1) adverse drug reaction not expected from the Local Product Document (LPD) (unlisted adverse drug reaction), 2) the incidence of adverse drug reactions in this surveillance, and 3)factors considered to affect the safety and/or efficacy of this drug.

All the patients whom an investigator prescribes the first Rescriptor® should be registered consecutively until the number of subjects reaches target number in order to extract patients enrolled into the investigation at random.

Eligibility Criteria:
Inclusion Criteria:

Patients need to be administered Rescriptor® in order to be enrolled in the surveillance.

Exclusion Criteria:

Patients not administered Rescriptor®.
The Impact of Polycystic Ovary Syndrome (PCOS) on Quality of Life and Healthcare Beliefs

Women with Polycystic Ovary Syndrome (PCOS) between the age of 18 and 55 are being recruited to participate in an online survey to determine the impact of PCOS on quality of life and interaction with the healthcare system. This online survey will take 15-20 minutes to complete. Participants will receive no direct benefit, but the information provided will contribute to the knowledge of this condition and the development of improved healthcare for women with PCOS. For more information or to participate in this study, please visit http://pcossurvey.vze.com


Eligibility Criteria:
Inclusion Criteria:

* Women with Polycystic Ovary Syndrome (PCOS) between the age of 18 and 55

Exclusion Criteria:

* N/A
Making Sense Out of Total Knee Sensor Assisted Technology: A Randomized Control Trial

The purpose of this study is to compare the patient reported outcome measures of total knee replacement patients who received intra operative sensor guided technique for soft tissue balancing to a group of patients who receive surgeon guided soft tissue balancing.

This study will compare a group of total knee arthroplasty patients who receive sensor guidance technology for soft tissue balancing intra operatively to a group of patients who receive surgeon guided soft tissue balancing. Patients will be randomized to either the experimental group with the sensor guided technology or the control group which is the surgeon guided technique and current standard of care. All patients will have the sensor placed intra operatively so that measurements can be captured and recorded however, the measurements for the patients who are not in the sensor guided group will not be revealed to the surgeon. The information will be gathered for post enrollment data analysis only. The patients measurements in the sensor guided group will be revealed to the surgeon and the surgeon will use this information in order to help guide soft tissue balancing for optimal alignment intra operatively. Patients will be followed for 1 year post operatively. Patient reported outcomes measures such as KSS, KOOS, PROMIS PF CAT, EQ-5D and UCLA activity will be collected preoperatively and at 3 months, 6 months, and 12 months. Post-operative Likert scale patient satisfaction scores will also be collected. All outcomes will be scored and compared to determine significance.

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing primary unilateral total knee arthroplasty for osteoarthritis, avascular necrosis, inflammatory arthropathy, or post traumatic arthritis.
* Patients able to understand study intent, and agree to study participation.
* Patients receiving Smith and Nephew Journey II total knee implant system.

Exclusion Criteria:

* Patients with previous ipsilateral knee ligament surgery.
* Patients with orthopaedic and medical co-morbidities that would thwart postoperative recovery such as extra-articular pathology with referred pain to the knee (spinal stenosis, neuropathy, ipsilateral hip disease), severe knee deformity.
* Untreated Osteoarthritis
* BMI \> 40
* ASA class \> III
* History of drug or alcohol abuse
Role of Topical Putrescine (Fibrostat) for Prevention of Hypertrophic Scars in Mammoplasty Patients

Linked to previous Clinical Trial E92:069 in which biochemical effect of 1,4 diaminobutane was studied in human scar harvested at revision surgery after a 12 week application. Analytical data was collected in this phase of the work completed in 1999. This was then followed by clinical correlation in a scar prevention model with topical application of 1,4 diaminobutane for 12 weeks and measuring duredness , as well photographic and POSAS score data for quality of scar formation.

In this study, patients were "randomized" into one of 2 study groups described below. They agreed to being treated on the right side or the left with active agent, while the other side was to receive inactive cream. The active molecule is called Fibrostat or 1,4 diaminobutane and is a naturally occurring inhibitor of scar formation. The inactive jar contains the vehicle alone without Fibrostat.

The patients received both cream types to be applied to the appropriate side assigned by the randomization process, one numbered jar each per breast in the order and amount as explained in detail by the patient educator. The cream was applied daily and in the same order, one jar for the right and the other jar for the left consistently. The randomization was performed at the factory with an assigned number recorded on each jar and the jar contents listed and recorded with its assigned number. Each jar of active cream is randomly assigned with another jar of inactive cream to form a pair which were both given to the patient. The cream in both jars looks and smells the same. Neither the patient nor the study doctor knew which breast as receiving the active agent. In an emergency, this information was to be made available.

Participation in the study was for 12 weeks. the patients were seen for photos and scar testing using a painless surface testing device called a Rex® durometer at 1, 3, 6, and 12 weeks post op.

The researcher could decide to take patients off this study if a patient were to develop a rash during the run-in period of 1 week from the cream on either side.

The patients could stop participating at any time. However, this was usually accompanied by a valid reason such as lack of transportation to regular follow up appointments. No serious effects were seen and the only patients to stop participation in the study except 1 which was lost to follow-up could be accounted for. The results were revealed to patients at the completion of the 12 week trial.

Eligibility Criteria:
Inclusion Criteria: Undergoing breast reduction surgery -

Exclusion Criteria: Not pregnant or lactating

-
Post Marketing Surveillance Study To Observe Safety And Efficacy Of Aromasin In The Patients With Early Or Advanced Breast Cancer

This non-interventional study is to monitor use in real practice in Korea including adverse events on Aromasin (Exemestane).

All cases at the participating institutions.

Eligibility Criteria:
Inclusion Criteria:

* - Postmenopausal women with breast cancer eligible for hormonal therapy.

Exclusion Criteria:

* Pregnant breast-feeding premenopausal.
Non-invasive Estimation of CSF Pressure Using MRI in Patients With Spontaneous Intracranial Hypotension

The purpose of this study is to estimate the intracranial pressure (ICP, the pressure in your head) in subjects with intracranial hypotension (a condition caused by leakage of the fluid that surrounds your brain and spine) using non-invasive magnetic resonance imaging (MRI) techniques, and to determine whether changes in estimated ICP are seen after treatment of this condition.

Subjects with known intracranial hypotension who are scheduled to undergo standard-of-care CSF pressure measurement using lumbar puncture prior to planned epidural patch treatment will first undergo a research MRI of the brain in order to estimate ICP. The imaging protocol is listed in Appendix 1. All research scans are performed without intravenous contrast. Approximate scan time per session will be 20-22 minutes.

Subjects will then undergo lumbar puncture according to the standard-of-care treatment plan. Estimated values of CSF pressure derived from MRI will be compared to values measured during lumbar puncture. Patients will then undergo standard-of-care epidural patching. A repeat research MRI after epidural patching will be performed to assess for differences in pre- and post-treatment scans.

Eligibility Criteria:
Inclusion Criteria:

* Known diagnosis of intracranial hypotension, established by the following criteria: the presence of orthostatic headache, and one or more of the following criteria: prior CSF opening pressure ≤6 cmH20, demonstration of an active spinal CSF leak on prior spine imaging, or cranial MRI changes of intracranial hypotension.15
* Ability to provide informed consent.
* Expected ability to complete standard-of-care procedures (lumbar puncture and epidural patching)

Exclusion Criteria:

* Known contraindication to MRI (pacemaker, MRI incompatible hardware, etc.)
* Severe claustrophobia or other condition requiring the need for anxiolysis, sedation, or any other medication for MRI scanning
* Inability or expected inability to complete study interventions as scheduled
* Any known contraindication to standard-of-care procedures (e.g. coagulopathy, allergic reaction to required medication, lack of vascular access, etc.)