cyrilzakka/clinical-trials huggingface dataset:
Safety and Efficacy of the HA-based Dermal Fillers HYAcorp Lips and Face

Purpose of this study is the demonstration of safety and efficacy of the dermal fillers HYAcorp Lips and HYAcorp Face for restoration of the facial volume and contour.

This is a prospective, multicenter, observational, open label, two-arm, crossover, PMCF clinical trial for demonstration of the safety and efficacy of the HA-based dermal fillers HYAcorp Lips and HYAcorp Face for restoration of the facial volume and contour. Besides safety aspects, evaluated immediately after the treatment, 4 weeks, 3 and 6 months after the treatment, the performance of the demal fillers are evaluated in the 3 and 6 months follow-up by using GAIS and WSRS.

Eligibility Criteria:
Inclusion Criteria:

* subjects intended for the treatment with HYAcorp Lips and/or Face according to the instructions for use of the product
* decision for the treatment with HYAcorp Lips and/or Face was made before the subject was recruited for the clinical trial
* subjects signed written informed consent
* adult subjects at least 18 years old
* all Fitzpatrick skin types
* area treated with one investigational device - no combination of products in one treatment area

Exclusion Criteria:

* tendency to hypertrophic and keloid scarring
* intolerance to gram-positive bacteria
* prone to active inflammatory or infectious processes
* suffering from acute or chronic skin diseases
* undergoing anti-coagulant therapy
* known allergy to hyaluronic acid
* suffering from autoimmune diseases
* multiple allergies
* pregnancy or lactating women
* subjects unlikely to cooperate in the clinical investigation or to comply with the treatment or with the clinical investigation visits
Frozen Embryo Transfer in PCOS Patients

Polycystic ovarian syndrome (PCOS) is condition characterized by being complex, familial and polygenetic metabolic condition with heterogeneous involvement of several genes in the hypothalamic-pituitary-gonadal axis. PCOS is the most incident endocrine-metabolic syndrome that is characterized by hyperandrogenemia, menstrual irregularities, and/or small cysts in one or both ovaries and could be considered as the main cause of female infertility.

Assisted reproductive technologies (ART) were defined by the American Center for Disease Control as any fertility-related treatments where eggs or embryos are manipulated. In vitro fertilization involves the transfer of fresh embryos, however, the freeze-all strategy that entails cryopreservation of all embryos to be transferred subsequently in un-stimulated cycle to guard against the negative effects of controlled ovarian stimulation on the endometrium and to minimize the risk of ovarian hyper-stimulation syndrome. Intracytroplasmatic sperm injection (ICSI) is a common procedure used to improve reproductive results, even among couples without male factor infertility.

However, there are several points of controversy in the fields of ART traditionally, multiple embryo transfer strategy was used to increase the chance for getting a baby, however, multiple pregnancy is a common complication for this strategy with subsequent adverse fetal, maternal and neonatal outcomes. Also, the developmental stage of embryos at time of transfer; cleavage versus blastocyst was a matter of debit, but giving the chance for in-vitro maturation to the stage of blastocyst increased the possibility of getting good quality embryo to be transferred. However, the exaggeration of prolongation of the in-vitro duration appeared as a trend, but recent studies found no advantages for transfer of D7 or D6 blastocyst over D5 blastocyst transfer (BT).


Eligibility Criteria:
Inclusion Criteria:

* Infertile women fulfilling at least two of the Rotterdam criteria for diagnosis of PCOS;
* aged 20-35 years;
* had body mass index (BMI) of less than 35 kg/m2;
* mild hirsutism on Ferriman-Gallwey (FG) visual scoring system;
* their hormonal profile of serum AMH \>4.5, FSH \<5.85 LH\>5.39;
* had no previous attempts of ICSI were included in the study.

Exclusion Criteria:

* Patients who were out of the predetermined age range and BMI;
* had uterine abnormalities;
* hydrosaplnix;
* recurrent miscarriage;
* medical diseases interfering with or being complicated by occurrence of pregnancy;
* cases requiring ICSI with TESE samples;
* had obesity-inducing endocrinopathy
* severe symptomatizing hypovitaminosis or maintained on hormonal contraception within the last 6 months before inclusion in the study, were excluded from the study.
Prospective and Non-randomized Registry of CardioCel 3D

Post-market, prospective, multi-centre, open-label, registry designed to collect prospective safety and performance data on the use of CardioCel in patients with cardiovascular disorders and in accordance with local standard of care.

The Registry will collect data with a minimum of 50 subjects per major indication (minimum total of 200) in 5-10 sites in Europe. The clinical investigation will maintain data for each patient from the date of implant through 2 years post-implantation.

Post-market, prospective, multi-centre, open-label, registry designed to collect prospective safety and performance data on the use of CardioCel in patients with cardiovascular disorders and in accordance with local standard of care. The Registry has been designed to collect prospective product safety and performance data after the CardioCel line extension for CardioCel 3D and the indication expansion to include great vessel and peripheral reconstruction and suture line buttressing and will collect safety and performance data up to 2 years following implantation. The CardioCel 3D Registry will collect data on the use of the CardioCel,

CardioCel Neo and CardioCel 3D for the following major indications:

* Intracardiac and septal defects
* Valve and annulus repair
* Great vessel reconstruction
* Peripheral vascular reconstruction

As suture line buttressing is a procedure that does not consistently use tissue, data on this indication will only be included if available. Data will be prospectively collected by the sites on registry-specific electronic case report forms (eCRFs). The primary endpoints will assess devices' safety and performance through measures and images obtained via the facility's standard of care at the respective registry site. Additional data will also be collected from the implant procedure to assess user (surgeon) satisfaction with the devices' handling and performance.

Eligibility Criteria:
Inclusion Criteria:

* patient has signed the informed consent
* patient is a candidate for treatment with CardioCel/CardioCel Neo/CardioCel 3D per approved device indications.

Exclusion Criteria:

- no study specific exclusion criteria; patients treated per standard clinical practice
Safety and Efficacy of Mometasone Furoate Nasal Spray With the Addition of Loratadine Versus Placebo in Participants With Seasonal Allergic Rhinitis (C94-145)

The purpose of this study is to evaluate the safety and efficacy of mometasone furoate nasal spray (MFNS) with the addition of loratadine vs MFNS alone, loratadine alone, or placebo, in the treatment of patients with seasonal allergic rhinitis.


Eligibility Criteria:
Inclusion Criteria:

* 2-year history of seasonal allergic rhinitis
* Positive skin test response to a local seasonal allergen (current, or performed in investigator's office within the past year)
* Good health and free of any unstable, clinically significant disease, other than allergic rhinitis, that would interfere with the study schedule or evaluation of seasonal allergic rhinitis

Exclusion Criteria:

* Women who are pregnant or breastfeeding
* Women of childbearing potential who are not using an acceptable form of birth control
* Significant history of metabolic, cardiovascular, neurologic, hematologic, hepatic, gastrointestinal, cerebrovascular, respiratory, or renal disease, or any other disorder which, in the judgment of the investigator, could interfere with the study, or require treatment which might interfere with the study
* Use of any chronic medication which could affect the course of seasonal allergic rhinitis
* Asthma requiring chronic use of inhaled or systemic corticosteroids (inhaled bronchodilators are permitted for asthma treatment)
* Current or history of frequent, clinically significant sinusitis or chronic purulent postnasal drip
* Upper respiratory tract or sinus infection that requires antibiotic therapy within the previous 2 weeks, or a viral upper respiratory infection (URI) within the 7 days prior to Screening
* Dependence upon nasal, oral or ocular decongestants, or nasal topical antihistamines, in the opinion of the investigator
* Has rhinitis medicamentosa
* Evidence of clinically significant nasal candidiasis
* Investigational drug use within the previous 30 days
* Nasal structural abnormalities, including large nasal polyps and marked septal deviation, that significantly interfere with nasal air flow
* Immunotherapy (desensitization therapy), unless on a stable maintenance schedule for at least one month prior to the Screening visit
* History of multiple drug allergies, allergy to antihistamines or corticoids
* History of psychosis, antagonistic personality, poor motivation, hypochondriasis, or any other emotional or intellectual problems that are likely to limit the validity of consent to participate in the study
3-dimensional Versus 2-dimensional Laparoscopy for Hysterectomy

The aim of this study is to compare the surgical outcomes and efficacy of 3-dimensional (3D) versus 2-dimensional (2D) imaging systems in laparoscopic hysterectomy.

Laparoscopy is founded as a treatment of choice for benign uterine disease. The advantages of laparoscopic surgery over conventional open surgery are less pain, shorter recovery time, shorter hospital stay, and consequently faster return to normal activity as well as better cosmetic effects. However, laparoscopic surgery is more demanding compared with open surgery because operators should project three-dimensional (3D) field through a two-dimensional (2D) monitor.

However, to date, studies examining the possible benefits and drawbacks of 3D imaging system versus 2D in laparoscopic surgery have brought about conflicting results. Moreover, there have been few studies comparing the surgical outcomes of 3D and 2D laparoscopic laparoscopic hysterectomy. The aim of this study is to compare the surgical outcomes and efficacy of 3-dimensional (3D) versus 2-dimensional (2D) imaging systems in laparoscopic hysterectomy.

Eligibility Criteria:
Inclusion Criteria:

* Uterine myoma requiring laparoscopic myomectomy
* American Society of Anesthesiologists physical status (ASAPS) classification I-II
* absence of pregnancy at the time of surgery.

Exclusion Criteria:

* any suspicious findings of malignant gynecologic diseases,
Targeted ACT Compared to Supportive Therapy for Depression RCT

Acceptance and Commitment Therapy (ACT) has demonstrated efficacy in reducing depressive symptoms, primarily compared to no treatment or minimal treatment controls. This study compared the efficacy of ACT targeting cognitive defusion (CD, 3 sessions) and values-based activity scheduling (VBAS, 3 sessions) to supportive therapy (ST). Both treatments offered six sessions, a rationale for the approach, related techniques, and homework assignments. A parallel group randomized controlled efficacy trial design was used. Participants were stratified by gender identification and depression severity and then randomly allocated, according to a predetermined sequence, 2:1 to ACT or ST. Dependent measures were collected during acute treatment (pre, mid, and post-treatment) and follow-up at one-month.


Eligibility Criteria:
Inclusion Criteria:

* 18 years or older
* Scored one SD below the mean on the RSES and BSI
* Proficiency in English
* If taking medication for psychiatric reasons, stable medication use for at least eight weeks prior to enrollment and agreement to no changes in dosing during study participation.

Exclusion Criteria:

* Receiving other forms of psychological treatment
* Meeting PDSQ Interview criteria for psychosis, panic disorder, substance use, or endorsement of significant suicidal ideation
The Effects of a Home-based Occupational Therapy Tele-rehabilitation for Outpatients After Hip Fracture Surgery

The investigators will investigate the effects of a home-based occupational therapy telerehabilitation (TR) via smartphones in enhancing functional and motor performances, and fall efficacy, for outpatients receiving day hospital rehabilitation after hip fracture surgery.

This is a feasibility randomized controlled trial with two groups - experimental and comparison groups, involving older adults after hip fracture surgery within 12 weeks attending the Geriatric Day Hospital. Patients will be assessed at baseline, immediately post 3-weeks intervention, and follow-up after 3-weeks for motor performances, daily activities functioning and fall efficacy. The experimental group will receive home program using the use of Caspar Health e-system and a mobile app in smartphones, while the comparison group will receive paper-and-pencil instructions for the home program on weekly basis, for 3 weeks.


Eligibility Criteria:
Inclusion Criteria:

* Primary diagnosis of hip fracture
* Post-hip surgery within 12 weeks
* Aged 60 years old or above
* Medically stable
* With Abbreviated Mental Test scored 6 or above
* Having at least one functional limitation in the basic activities of daily living assessments

Exclusion Criteria:

* The hip fracture is the result of malignancy
* There is risk of falls due to postural hypotension
* Either patients or caregiver do not understand Cantonese, English or Mandarin instructions
* They do not use a smartphone
* They are unable to read the instructions on the screen of the smartphone because of visual difficulty
Effect of Mindfulness-based Stress Reduction Intervention on Psychological Distress and Hope Among Female Patients Undergoing Radiotherapy for Breast Cancer

Breast cancer is a significant issue in Egypt, affecting a large number of women and impacting their psychological well-being. Younger patients and those undergoing adjuvant therapy or radiotherapy are particularly susceptible to psychological distress. Psychological counseling and support groups can help improve patients' quality of life and social functioning. Hope plays a crucial role in the treatment process, as it is associated with positive outcomes and serves as a protective mechanism against stress and disease. Mindfulness-Based Stress Reduction (MBSR) is an intervention that can reduce stress and depression in cancer patients. It involves cultivating awareness of the present moment and has positive effects on quality of life. Investigating the impact of MBSR on psychological distress and hope in women undergoing radiotherapy for breast cancer is important for providing effective support during treatment.

The aim of this study is to:

Examine the effect of the Mindfulness-Based Stress reduction intervention on psychological distress and hope among female patients undergoing radiotherapy for breast cancer.

RESEARCH HYPOTHESIS Female patients undergoing radiotherapy for breast cancer who attend Mindfulness-Based Stress reduction intervention sessions exhibit higher levels of hope and lower levels of psychological distress compared to those who receive conventional hospital treatment.


Eligibility Criteria:
Inclusion Criteria:

* Adult female patients with post-mastectomy (within one to six months).
* Able to communicate verbally.
* Able to read and write.
* Willing to participate in the study.

Exclusion Criteria:

* other associated diseases such as (renal disease, ischemic heart disease, liver disease) will e excluded.
A Phase I/II Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Initial Efficacy of JS212 in Subjects With Advanced Malignant Solid Tumour

This study is a Phase I/II Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Initial Efficacy of JS212 in Subjects with Advanced Malignant Solid Tumour. Patients will be enrolled in two stages: a dose-escalation stage and a dose expansion stage.


Eligibility Criteria:
Inclusion Criteria:

1. Subjects of either sex who are 18 to 75 years of age (inclusive of 18 and 75 years) at the time of signing the consent form;
2. Histologically or cytologically confirmed advanced malignant solid tumors;
3. Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1;
4. Expected survival of ≥ 12 weeks;
5. Subjects have at least 1 measurable lesion according to RECIST v1.1 criteria (without measurable lesions are allowed during dose escalation phase);

Exclusion Criteria:

1. Presence of active central nervous system metastasis. If previous radiotherapy or surgery, etc. has been received, and the imaging examination within 4 weeks before the first dose suggests that the brain metastasis is stable without exacerbation or new neurological symptoms, and hormone therapy has been discontinued two weeks before the first dose, screening is allowed; for the presence of meningeal metastasis and brainstem metastasis, regardless of the treatment or not, screening is not allowed;
2. Presence of clinically symptomatic pleural effusion, ascites, or pericardial effusion that requires repeated management (puncture or drainage, etc.);
3. Presence of medically uncontrolled hypertension, or with a history of hypertensive crisis or hypertensive encephalopathy;
4. Presence of a history of (non-infectious) interstitial lung disease (ILD)/non-infectious pneumonia requiring steroid therapy (e.g., idiopathic pulmonary fibrosis, mechanized pneumonia, drug-induced pneumonia, radiation pneumonitis, idiopathic pneumonia, etc.), and current ILD/non-infectious pneumonia;
5. Presence of clinically significant lung-specific co-morbidities including, but not limited to, any underlying lung disease (e.g., pulmonary embolism, severe asthma, severe COPD, restrictive lung disease, etc., diagnosed within 3 months prior to the first study dose) and any autoimmune, connective tissue, or inflammatory disease with pulmonary involvement (e.g., rheumatoid arthritis, Scheugelin's syndrome, sarcoidosis, etc.) and prior total pneumonectomy;
6. Presence of a history of immunodeficiency, including a positive test for Human Immunodeficiency Virus (HIV), or a known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation；
7. the presence of other factors that may cause them to be forced to terminate the study midway, such as serious physical or mental illness or abnormal laboratory tests, which may increase the risk of participation in the study, affect treatment compliance, or interfere with the results of the study, and which, in the judgment of the investigator, make the subject unsuitable for participation in this study；
Cerebral Safety After Pulsed-Field Ablation of Atrial Fibrillation

A study evaluating the incidence of ischaemic lesions detected by brain MRI scan in subjects undergoing pulsed-field ablation for atrial fibrillation (VARIPULSE system).

An observational study evaluating the incidence of ischaemic lesions on brain MRI performed after ablation of atrial fibrillation using the Varipulse catheter.

1. A baseline MRI scan will be carried out one day before the procedure.
2. A post-procedure MRI scan will be performed 24-36 hours after the procedure.
3. A follow-up MRI will be performed within 1 year after the ablation.

Paroxysmal and non-paroxysmal AF patients will be included. Regarding the extent of ablation lesions, pulmonary vein isolation (PVI) will be performed in paroxysmal AF, whereas PVI + left atrial posterior wall ablation will be performed in non-paroxysmal patients. All procedures will be performed under intracardiac echocardiography guidance.

The patients will undergo a neurocognitive evaluation:

1. One day before the procedure: Montreal Cognitive Assessment (The MoCA Test)
2. 24-36 hours after the procedure: The National Institutes of Health Stroke Scale (NIHSS)
3. Up to 1 year after the procedure the MoCA test.

Eligibility Criteria:
Inclusion Criteria:

* AF with an indication for ablation

Exclusion Criteria:

* MRI contraindication
Evaluating Progression of and Diagnostic Tools for Primary Ciliary Dyskinesia in Children and Adolescents

Mucociliary clearance, in which mucus secretions are cleared from the breathing airways, is the primary defense mechanism for the lungs. Inhaled particles, including microbes that can cause infections, are normally entrapped in mucus on the airway surfaces and then cleared out by the coordinated action of tiny hair-like structures called cilia. Individuals with primary ciliary dyskinesia (PCD) have defective mucociliary clearance, which in turn leads to lung infections and disease. The purpose of this study is to determine how lung disease progresses over time in children and adolescents with PCD.

PCD is a rare genetic disorder in which impaired mucus clearance commonly results in chronic cough and infections in the airways, sinuses, and middle ears. Long lasting airway infection ultimately leads to structural damage to the airways, known as bronchiectasis, and, in turn, loss of lung function. While PCD shares some similarities with the disease cystic fibrosis, it is important to distinguish PCD from cystic fibrosis. In particular, the age of onset and progression of PCD's clinical lung disease, including timing of specific microbial pathogen infections and bronchiectasis, remain poorly defined. The purpose of this study is to determine how lung disease progresses over time in children and adolescents with PCD. Specific attention will be directed toward determining whether certain factors play a role in lung disease progression. The study will also evaluate diagnostic tools and quality of life among individuals with PCD. Filling these gaps of knowledge may help to improve the clinical management of PCD in the future.

This longitudinal study will last 5 years. There will be a total of 5 study visits, and these visits will occur yearly. Each study visit will last 3 to 4 hours. All study visits will include a medical history review; physical exam; height, weight, and vital sign measurements; sampling of respiratory fluids and mucus; lung function tests; and questionnaires. The initial visit may also include using a probe to measure nasal nitric oxide levels and blood collection for genetic testing. Study visits 1, 3, and 5 will also include blood collection for pregnancy testing and a high resolution computed tomography (HRCT) scan of the chest to image the lungs. At the end of each month, participants will report any use of oral, inhaled, or intravenous antibiotics.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of PCD or probable PCD. More information about the criteria for a PCD diagnosis can be found in the protocol.
* Parent or guardian willing to provide informed consent

Exclusion Criteria:

* Inability to attend follow-up appointments
* Previously received lung transplant
* Any disease that may have significant impact on lung function (e.g., severe congenital heart disease, severe scoliosis), respiratory infections (e.g., AIDS), or overall health status (e.g., cancer, end-stage kidney disease)
* Pregnant or breastfeeding