cyrilzakka/clinical-trials huggingface dataset:
Clinical Performance of the Asqelio™ Trifocal Diffractive Intraocular Lens

The goal of this observational study is to evaluate whether the Asqelio™ Trifocal intraocular lens (IOL) can improve refractive outcomes and optical quality in patients (aged ≥45 years) undergoing cataract surgery or clear lens exchange, including both male and female participants. The main questions it aims to answer are:

* Does the Asqelio™ Trifocal IOL provide accurate refractive correction with minimal residual refractive error?
* Does the lens reduce light distortion and provide good visual acuity at multiple distances (far, intermediate, near)?

Researchers will not use a comparison group, as this is a post-marketing, single-arm observational study.

Participants will undergo bilateral implantation of the Asqelio™ Trifocal IOL during cataract or lens replacement surgery and attend a study follow-up exam approximately 270±90 days post-surgery.

Complete evaluations including:

* Manifest refraction testing
* Uncorrected and corrected visual acuity at far, intermediate, and near distances
* Binocular defocus curve analysis
* Contrast sensitivity testing
* Light distortion analysis using a Light Distortion Analyzer
* Patient-reported outcomes via the Catquest-9SF and visual symptoms questionnaires.


Eligibility Criteria:
Inclusion Criteria:

* Patients 50 years of age or older undergoing cataract surgery by phacoemulsification and binocular IOL implant AsqelioTM Trifocal TFLIO130C
* Independence of use of glasses after surgery.
* IOL power between +5.0D and +34.0D
* Transparent intraocular media except for cataracts in both eyes.
* Potential postoperative visual acuity of 20/25 or better.

Exclusion Criteria:

* Preoperative corneal astigmatism greater than 1.0D
* Previous corneal surgery or trauma.
* Irregular cornea (e.g. keratoconus)
* Choroidal hemorrhage
* Microphtalmos
* Severe corneal dystrophy
* Uncontrolled or medically controlled glaucoma
* Clinically significant macular changes
* Concomitant severe eye disease
* Non-age-related cataract
* Severe optic nerve atrophy
* Diabetic retinopathy
* Proliferative diabetic retinopathy
* Amblyopia
* Extremely shallow anterior camera
* Severe chronic uveitis
* Pregnant or nursing
* Rubella
* Mature/dense cataract that makes it difficult to examine the eye fundus preoperatively.
* Previous retinal detachment
* Concurrent participation in other research with drugs or clinical devices
A Clinical Trial of Silk Peptide for the Evaluation of Efficacy on Immune Function

This study is a 8-week, randomized, double-blind, placebo-controlled clinical trial of Silk Peptide for the evaluation of efficacy on immune function enhancement.

This study will evaluate Silk Peptide's efficacy on immune function in healthy volunteers who white blood cells count is in between 4000/㎕ and 8000/㎕ by assessing improvements in certain immune indices (i.e. NK cell activity, IFN-γ, TNF-α, IL-1β, 2, 12, IgG1, IgG2).

Eligibility Criteria:
Inclusion Criteria:

1. Adult male and female volunteers over 50 years
2. Screening result for WBC counts in between 4,000 cells/ul and 8,000 cells/ul
3. Volunteers who have agreed to participate in the study and provided a written content by him/herself or through its legal representative

Exclusion Criteria:

1. Those with a history of drug and clinically significant hypersensitivity reactions
2. Those with thyroid or pituitary disease
3. Those with acute severe cardiovascular disease such as heart failure, myocardial infarction, and stroke
4. Those with immune system disease or severe liver failure, kidney failure or history
5. Those with a history of systemic diseases such as malignancy, lung disease, leukemia, collagenosis, multiple sclerosis, allergic skin disease and other autoimmune diseases
6. Those with a BMI of less than 18.5 kg/m2 at screening
7. Those diagnosed with diabetes
8. Those with a history of gastrointestinal disorders (ex. Crohn's disease) or gastrointestinal surgery (excluding simple appendectomy or hernia surgery) that may affect the absorption of clinical trial products
9. Those who have consumed medicines, healthy functional foods within 2 weeks before screening or are currently consuming health supplements that can affect immune function. (For health functional foods, they can participate through 1 week before the first intake day.)
10. Those who have received antipsychotic medication within 2 months before screening
11. Those with a alcoholism or history of substance abuse
12. Those who participated in other clinical trials within 2 months before screening
13. Those who are pregnant, breastfeeding
14. Fertile women who do not accept the appropriate method of contraception (except for women who have undergone sterilization operation)
15. Those who are deemed inappropriate by the researcher
Nutritional State and Care Pathway of Hospitalized Malnourished Patients, Within 3 Months of Admission

Malnourished patients are at risk of many complications, including infections, pressure ulcers and readmissions. Little is known about their care pathway after hospital discharge.

This study aims to determine care pathways of malnourished patients after hospital discharge and to determine what they need to better take care of their malnutrition.

All patients hospitalized in the post-emergency unit of Rennes University Hospital during the study period will be screened for malnutrition.

Data concerning newly diagnosed malnourished patients will be recorded and those patients will be contacted 3 months after their hospital discharge.

A qualitative study will be conducted among malnourished patients and their families : a sample of patients and their caregivers will be interviewed to better understand their perception of malnutrition and what they need to better take care of malnutrition.

Eligibility Criteria:
Inclusion Criteria:

* Malnourished patients, hospitalized in the post-emergency unit during the study period, according to the malnutrition diagnostic criteria defined by the French Health Authority :
* age ≥ 70 years old: weight loss ≥ 5% within 1 month or ≥ 10% within 6 months and/or BMI \<21 and or serum albumin level \< 35 g/l
* age \< 70 years old : weight loss ≥ 5% in 1 month or ≥ 10% in 6 months or ≥ 10% compared to the usual weight before the onset of the disease; or BMI \<18.5 kg / m2

Non-inclusion criteria :

* refusing to participate in the study
* age \< 18 years old
* patients under tutorship or guardianship
* patients living in retirement home
* Patients without a fixed address

Exclusion criteria :

-patients transferred in another unit
A Study Comparing Music Therapy and Cognitive Behavioral Therapy for Anxiety in Cancer Survivors

The researchers are doing this study to compare how music therapy and cognitive behavioral therapy, given virtually, may be able to reduce anxiety in people who have had cancer. In addition, this study will see if certain factors affect how well participants respond to music therapy or cognitive behavioral therapy. For example, the researchers will see if personal characteristics (like age, sex, race, and education) and ways of thinking (like expectations of therapy) may affect how well participants respond.


Eligibility Criteria:
Inclusion Criteria:

* English- or Spanish-speaking
* 18 years or older
* Prior cancer diagnosis of any type or stage
* Free of oncological disease, or stable disease with no evidence of progression
* Score of ≥8 on the anxiety subscale of the Hospital Anxiety and Depression Scale (HADS)
* Report anxiety symptoms lasting at least one month
* Willing to adhere to all study-related procedures, including randomization to one of two treatment arms: MT or CBT
* Access to Zoom and a quiet/private location

Inclusion Criteria for Advanced Cancer Sub-Study (N=50)

* English-speaking
* 18 years or older
* Advanced cancer diagnosis: stage III or IV lung cancer; any stage pancreatic cancer, unresectable cholangiocarcinoma, unresectable liver cancer, unresectable ampullary or peri-ampullary cancer, or other stage IV gastrointestinal cancer; stage III or IV ovarian or fallopian tube cancers or other stage IV gynecologic cancer; stage IV breast cancer; stage III testicular cancer or any stage IV genitourinary cancer; stage IV sarcoma; stage IV melanoma; stage IV endocrine cancer; lymphoma, myeloma, or leukemia
* Currently receiving oncological treatment or on active surveillance
* Karnofsky performance score of ≥60
* Score of ≥8 on the HADS anxiety subscale
* Anxiety symptoms lasting for at least 1 month
* Greater than 6-month expected survival as judged by the treating oncologist
* Willing to adhere to all study procedures
* Access to Zoom and a quiet/private location

Exclusion Criteria:

* Completed active cancer treatment (e.g., surgery, radiation, chemotherapy) less than one month prior to enrollment (maintenance hormonal or targeted therapies are allowed).
* Active suicidal ideation, bipolar disorder, schizophrenia, or substance abuse
* Score of ≥10 indicative of cognitive impairment on the Blessed Orientation-Memory-Concentration
* Received a treatment course of seven or greater MT or CBT sessions for anxiety symptoms within the last six months
* Unable to provide informed consent for themselves

Exclusion Criteria for Advanced Cancer Sub-Study

* Active suicidal ideation; bipolar disorder, schizophrenia, or substance abuse
* Score of ≥10 on Blessed Orientation-Memory-Concentration
* Prior receipt of MT within the past six months
* Plan to receive any form of psychotherapy in the coming 8 weeks
* Initiation or change in anxiety medications within the past 4 weeks
* Plan to initiate or change anxiety medications in the coming 8 weeks
* Unable to provide informed consent for themselves
Airway Clearance in Bronchiectasis: is Non-Invasive Ventilation a Useful Adjunct in Moderate to Severe Disease?

This clinical trial is investigating the efficacy of Non Invasive Ventilation (NIV) as a method of airway clearance in patients with an acute exacerbation and moderate to severe bronchiectasis disease. Current treatment focuses on the use of Active Cycle of Breathing Techniques (ACBT) but this modality alone may not be sufficient when patients have more severe disease and an acute infection. The use of NIV may result in better patient care and more appropriate physiotherapy treatment in the more unwell population.The aim of this study is to compare the efficacy of two physiotherapy airways clearance interventions in bronchiectasis.

Twenty patients with moderate to severe bronchiectasis admitted to hospital with an acute exacerbation were recruited (October 2004 to April 2006) and allocated to one of two groups that received twice daily airway clearance treatment for a course of IVAB. Group 1 {ACBT} and group 2 {NIV and ACBT}. A number of measurements were recorded on the first and final day of treatment as well as daily to provide important comparative information on physiological changes, ease of use, and clinical efficacy.

Outcomes measured on day 1 and final day of IVAB were: LifeshirtTM which recorded tidal volume; respiratory rate; airway flow; thoracoabdominal coordination; oxygen saturation and heart rate during treatment; respiratory muscle strength (PImax and PEmax); spirometry; arterial blood gases (ABGs); breathlessness scores; patients perception of tiredness, benefit and ease of treatment; auscultation; number of coughs per treatment; duration of treatment; sputum production, wet and dry weight; sputum rheology.

The Lifeshirt is a novel technique (respiratory induction plethysmography)which provides data on a wide range of dynamic lung function values (lung volumes; flow volume curves; relative excursion of rib cage and abdomen; SpO2) during airway clearance intervention to help understanding of the possible mechanisms of action of different airway clearance mechanisms.

Eligibility Criteria:
Inclusion Criteria:

* Moderate to severe bronchiectasis (FEV1 \< 60%),
* Indicators of difficulty expectorating sputum, and
* An acute exacerbation requiring intravenous antibiotics (IVAB)

Exclusion Criteria:

* Unable to tolerate positive pressure
* Presence of pneumothorax
High-activity Natural Killer Immunotherapy for Small Metastases of Non-small Cell Lung Cancer

The aim of this study is the safety and efficacy of high-activity natural killer immunotherapy to small metastases of non-small cell lung cancer.

By enrolling patients with small metastases of non-small cell lung cancer adapted to enrolled criteria, this study will document for the first time the safety and the short and long term efficacy of high-activity natural killer cells.

The safety will be evaluated by statistics of adverse reactions. The efficacy will be evaluated according to local relief degree, progress free survival (PFS) and overall survival (OS).

Eligibility Criteria:
Inclusion Criteria:

* All standard therapies have failed according to NCCN guidelines or the patient refuses standard therapies after cancer recurrence
* Body tumor 1-6, the maximum tumor length \< 2 cm
* KPS ≥ 70, lifespan \> 6 months
* Platelet count ≥ 80×109/L，white blood cell count ≥ 3×109/L, neutrophil count ≥ 2×109/L, hemoglobin ≥ 80 g/L

Exclusion Criteria:

* Patients with cardiac pacemaker
* Patients with brain metastasis
* Patients with grade 3 hypertension or diabetic complication, severe cardiac and pulmonary dysfunction
Sleep Respiratory Disorders in Patients With Moderate to Severe Persistent Rhinitis

The general aim of this study is to demonstrate that the measurement of respiratory effort assessed by mandibular movements during sleep is a useful measure for the screening of sleep disordered breathing (SDB) in patients with moderate to severe persistent rhinitis (R). The primary objective is therefore to determine a mandibular movement respiratory disturbance index (MM-RDI) threshold associated with a polysomnography respiratory disturbance index (PSG-RDI) ≥ 15 / h in a population of patients with moderate-to-severe persistent R.

The secondary objectives of the study are to evaluate the concordance and correlation between:

* MM-RDI,
* the respiratory effort evaluated by MM,
* polysomnography (PSG) results,
* quality of life questionnaires,
* clinical data,
* treatments.

Eligibility Criteria:
Inclusion Criteria:

* Patient consulting for persistant, moderate-to-severe rhinitis
* The patient has signed the informed consent
* The patient is a beneficiary of a social security programme (national health insurance)
* Patient living in the Montpellier region (\< 30 kilometers).

Exclusion Criteria:

* The patient is participating in another study that precludes participation in the present study
* The patient is in an exclusion period determined by another study
* It is impossible to correctly inform the patient
* The patient cannot fluently read French
* Vulnerable patient populations according to French Health Code article L1121-6
* Adult under guardianship or incapable of giving consent according to French Health Code article L1121-8
* Pregnancy, breastfeeding (French Health Code article L1121-5)
* Any element that renders participation in the study problematic according to the investigator
Dexpramipexole Japanese PK Study

This is a single and multiple dose, open-label study to evaluate the pharmacokinetics (PK), safety, and tolerability of dexpramipexole administered orally to adult Japanese and Caucasian healthy subjects.

The study is designed to evaluate the influence of ethnic factors on dexpramipexole safety, tolerability, and PK. Subjects will be admitted to the clinical unit on Day -1 (the day prior to first dosing) and will remain in the clinical unit under observation until discharge. All subjects will have a final follow up visit. Whilst resident in the clinic, subjects will receive 4 treatments: The first 3 treatments comprise Part A of the study and the final treatment group comprises Part B.

Part A:

Treatment 1: Dose 1 (reduced) of dexpramipexole; a single dose Treatment 2: Dose 2 (standard) dexpramipexole; a single dose Treatment 3: Dose 3 (standard) dexpramipexole; 5 doses administered at 12 hour intervals Part B: Dose 4 (standard) dexpramipexole; 5 doses administered at 12 hour intervals There will be a minimum washout of 3 days between treatments.

For all subjects, prior to proceeding to the next treatment group, safety and tolerability data will be reviewed.

Caucasian subjects will be matched individually (on a 1:1 basis) to Japanese subjects with respect to gender and age and if possible BMI.

Eligibility Criteria:
Inclusion Criteria:

* Subjects who are able and willing to give written informed consent.
* Adult Japanese and Caucasian males/females aged 18 to 60 years inclusive and between 18 and 30 kg/m2 body mass index (BMI), inclusive.
* Male and female subjects will be enrolled on the study. Male subjects and female subjects of childbearing potential, must practice effective contraception during the study and be willing and able to continue contraception for 1 month (females) or 3 months (males) after their last dose of study treatment
* Japanese subjects must be born in Japan and have both parents and four grandparents of Japanese descent.
* Japanese subjects must have lived outside of Japan for no more than 5 years.
* Japanese subjects must not have significant changes with regard to diet; i.e., their diet must not have significantly changed since leaving Japan.
* Caucasian subjects will be matched individually (on a 1:1 basis) to Japanese subjects with respect to gender and age, and if possible BMI.

Exclusion Criteria:

* Subjects who do not conform to the above inclusion criteria.
* Female subjects who are pregnant, trying to become pregnant or lactating.
* Subjects who have a clinically relevant history or presence of respiratory, gastrointestinal, renal, hepatic, hematological, lymphatic, neurological, cardiovascular, psychiatric, musculoskeletal, genitourinary, immunological, dermatological, connective tissue diseases or disorders.
* Subjects who have a clinically relevant surgical history.
* Subjects who have previously received dexpramipexole or pramipexole.
Foundations of Fitness Program Pilot

Approximately 17% of US children have obesity resulting in significant childhood co-morbidities and increased lifetime risk of adult obesity, diabetes, cardiovascular disease and cancer. Guidelines recommend intensive lifestyle programs as first-line treatment, yet few pediatric practices are equipped to provide this. Clinical-community partnerships are well-positioned to address this care gap. This proposal aims to assess whether a community-delivered lifestyle program offered in adjunct to primary care obesity management is feasible, acceptable, effective, and easily implemented in a rural care setting. In this study, approximately 40 children aged 7-13 years old and their caregiver pairs will be recruited from a primary care pediatric clinic. Child-adult dyads will participate in a 24-week program that includes 2 phases, a 12-week usual care phase and a 12-week intervention phase. The intervention phase will include bi-weekly meetings of a community intensive lifestyle program which focuses on healthy diet, daily physical activity, self-esteem and support for individual and family behavior change. A mixed-methods approach using qualitative interviews and study questionnaires, combined with objective measures of adiposity and fitness will assess study outcomes.


Eligibility Criteria:
Inclusion Criteria:

* Age 7-13 years;
* BMI% ≥85th%;
* Regional pediatric medical home patient;
* English speaking child and parent/caregiver;

Exclusion Criteria:

* Physical or developmental limitation to participation as determined by referring provider
Inspiratory Flow Using the Osmohaler

The OsmohalerTM is a registered device in Australia. It is used to deliver a dry powder a commercial preparation of mannitol registered as AridolTM to test if a person has irritable airways such as active asthma.

The overseas regulatory authorities need to know that people of all ages can achieve an adequate inspiratory flow through this device during a controlled deep inspiration. Adequate flow is generally regarded as greater than 30 litres per minute in children and 60 litres per minute in adults. The OsmohalerTM is a device with low resistance and is already in use in Australia to deliver mannitol. However there is a need to document inspiratory flows through the device during a controlled deep inspiration. The protocol requires subjects to perform a controlled deep inspiration from the device on three or five occasions. No substance will be inhaled.


Eligibility Criteria:
Inclusion Criteria:

* has asthma or is healthy
* aged 6 to 69 years inclusive
* FEV1 \>/= 70% predicted

Exclusion Criteria:

* has condition contraindicating performance of spirometrt
Optimal Handling of Common Bile Duct Calculus, a Prospective Study

The purpose is to study natural process of gallstones in common bile duct, stones less than or equal to 6 mm. And if the gallstones give any complications under 1 year follow up. The second outcome is to study side-effects of gallstones removed with surgery.


Eligibility Criteria:
Inclusion Criteria:

* cholecystectomy

Exclusion Criteria:

* Ongoing icterus or pancreatitis
* History of anamneses pancreatitis/icterus
* Allergy against x-ray contrast
* Stones more than 6 mm in ductus
* No passage of contrast to duodenum
* malignant
A Pilot Study Evaluating the Usability of the Oabi Mobile Application

Our primary purpose is to assess the use feasibility and acceptability of the study phone app called, "Oabi" app with patients diagnosed with overactive bladder disorder (OAB).

Tracking overactive bladder disorder can be an important part of managing the disease. It can help the patient and the health care providers keep a tab on what is working to help manage OAB symptoms. Tracking urination patterns can actually help patients normalize their bladder problems. By focusing on certain behaviors and habits that contribute to their OAB and changing those behaviors, patients can effectively control OAB symptoms. The Oabi mobile application has been created with the goal of helping patients learn more about their day-to-day symptoms as well as track and self-manage their symptoms. Additionally, the Oabi app connects patients with their HCP via a clinician portal to boost communication, and encourage patient-provider interaction. The goal of this pilot study is to evaluate the usability and acceptability of the Oabi mobile app.

Eligibility Criteria:
Inclusion Criteria:

* Patients with a primary diagnosis of OAB (with active OAB symptoms) with or without urge incontinence who are:

  * Treatment-naive patients who started a new treatment within two weeks prior to the study enrollment
  * Transitioning to another treatment (pharmacotherapy)
  * Transitioning from behavioral therapy to pharmacotherapy
* Adults aged 18 yrs and above.
* Own a Smartphone with Android Operating System with an OS of 5.0 or higher or willing to use a study phone as their primary for the duration of the study (Samsung Galaxy S6).
* Sufficient understanding of the English language to be able to read and understand study procedures.
* Willing to participate in the research study and sign informed consent.
* Has adequate access to the internet to use the app.

Exclusion Criteria:

* Subjects unable or unwilling to participate for at least three months.
* Subjects with vision, hearing, and/or speech problems that may limit their participation in data collection procedures.
* Subjects with physical limitations that limit may their ability to use a Smartphone, effectively navigate a Smartphone app, and type on a Smartphone.
* Participants with the history of urological surgery or those currently using a urinary sling.
* Participants on botox treatment for OAB.
* Participants with OAB symptoms due to coexisting conditions such as urinary tract infection (UTI), and or benign prostatic hypertrophy (BPH).