cyrilzakka/clinical-trials huggingface dataset:
Systemic Sclerosis Clinical and Biomarker Study

The primary objective of the study is to assess the change in systemic sclerosis (SSc)-associated gastrointestinal (GI) tract symptoms over a 1-year period in participants with SSc.

No study treatment will be administered. Study participants will continue to be treated by their respective physicians according to standard clinical practice. Data on concomitant therapy and procedures, administered as part of standard of care, will be collected at baseline and at each study visit.

Eligibility Criteria:
Key Inclusion Criteria:

Healthy volunteers

* Must be in good health as determined by the Investigator, based on medical history, physical examination, and vital signs.

Participants with diffuse cutaneous systemic sclerosis (dcSSc):

* Must fulfill the 2013 classification criteria for SSc of the American College of Rheumatology (ACR) and European League Against Rheumatism (EULAR).
* Absence of the anti-centromere autoantibody.

Participants with limited cutaneous systemic sclerosis (lcSSc):

* Must fulfill the 2013 classification criteria for SSc of the ACR and EULAR.
* Subjects with lcSSc must have disease duration of less than 5 years.

Key Exclusion Criteria:

* History of any clinically significant medical condition that can interfere with the conduct of the study, or that in the opinion of the Investigator, would compromise data interpretation.
* An active severe infection as determined by the Investigator.
* Female subjects who are pregnant or currently breastfeeding.
* A known history of malignancy.

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply
Medications Effect on Lenstar Measurements

Prior to cataract surgery the lens must be calculated to appropriately fit a patient for the intraocular lens implant. Lenstar is an optical biometer that calculates the axial length, keratometry, lens thickness, pupillometry, and anterior chamber depth. Dilation drops are routinely used in eye exams in addition to pre-cataract surgery. The dilation drops include Tropicamide 1%, and Phenylephrine 2.5%. The Tropicamide achieves the dilation of the pupil which causes an anterior rotation of the ciliary body, which may affect the Lenstar measurements. This study is to determine if dilating medications affect the lens power prediction for emmetropia by the Lenstar biometer. Prior to dilation, Lenstar biometry will be performed on each eye. Patients will receive dilation medication and after waiting 20 minutes Lenstar biometry will be performed on each eye. Dilation and measurement with Lenstar will be done as standard of care. Measurements and calculations from before and after will be compared.


Eligibility Criteria:
Inclusion Criteria:

* Candidates for cataract surgery undergoing routine evaluation of cataracts.

Exclusion Criteria:

* Patients that have had their cataracts removed
* Patients that cannot undergo routine evaluation for cataract surgery (because they are too ill to sit upright in a chair)
CBT for Insomnia With Anxiety and Depression

Objective to explore whether cbt-i plus is more effective and feasible for patients with insomnia complicated with anxiety and depression than the traditional cognitive behavioral therapy for insomnia.

Hypothesis: cbt-i plus is superior to cbt-i in efficacy and feasibility.

The purpose of this study was to explore the treatment of cognitive behavioral enhancement of insomnia (cbt-i plus), which was randomly divided into cbt-i plus intervention group (Study Group) and cbt-i intervention group (control group). The study group used the unified cognitive behavioral therapy manual for insomnia (cbt-i plus) for one-to-one individual treatment intervention, once a week, 45-50 minutes each time, a total of 8 times; the control group used the unified cognitive behavioral therapy manual for insomnia (cbt-i) for one-on-one treatment intervention, once a week, 45-50 minutes each time, a total of 8 times. The related indexes were evaluated at baseline, 2 weeks, 4 weeks and 8 weeks after enrollment, and were followed up at 12 weeks and 24 weeks after enrollment. Hypothesis: cbt-i plus is superior to cbt-i in efficacy and feasibility.

Eligibility Criteria:
Inclusion Criteria:

1. Age ≥18 years, male and female
2. Meet the diagnostic criteria of DSM-5 for insomnia, the Pittsburgh Sleep Quality Index (PSQI) scale total score ≥10
3. May be accompanied by depression symptoms, but currently does not meet any depression disorders diagnostic criteria,14≤HAMD-17≤23
4. May be accompanied by anxiety symptoms, but currently does not meet any anxiety disorders diagnostic criteria ,14≤HAMA≤29
5. Have sufficient education and understanding to complete this study to be examined and evaluated
6. Voluntary participation in this clinical trial and signature of informed consent.

Exclusion Criteria:

1. DSM-5 other sleep problems, such as apnea syndrome, restless leg syndrome
2. Women who are pregnant, nursing or planning to become pregnant during the study
3. Insomnia caused by alcohol or substance abuse
4. Severe cognitive problems
5. Patients who were previously or currently diagnosed as bipolar and related disorders, obsessive-compulsive and related disorders, schizophrenia spectrum and other psychotic disorders, trauma and stress related disorders, separation disorders, eating disorders
6. Patients with history of epilepsy or other serious somatic diseases
7. Persons receiving MECT treatment for nearly one month
8. Excluding those who have received systemic psychotherapy for more than 3 months in a row
9. The researchers believe that it is not suitable to participate in this clinical study.
Assessment of the Handling Experience With the BI 695501 Autoinjector in Patients With Rheumatoid Arthritis Followed by an Extension Phase Using BI 695501 Prefilled Syringe

This is an open-label, phase II study of BI 695501 to assess handling experience of patients with Rheumatoid Arthritis using an autoinjector. The extension phase is to provide patients with additional exposure to BI 695501 and to enhance the safety database for this compound.


Eligibility Criteria:
Inclusion criteria:

* Moderately to severely active Rheumatoid arthritis (RA) for at least 6 months, which is not adequately controlled by non-biologics DMARDs.
* No contraindications to anti-Tumor necrosis factor (TNF) agents.
* Either biologics naive or biologics-experienced but with no experience of self-administration medication using autoinjector or pen.
* Patients must be able and willing to self-inject BI 695501. Further inclusion criteria apply.

Exclusion criteria:

* Experience with self-administration of medication using an autoinjector or pen.
* American College of Rheumatology functional Class IV or wheelchair/ bed bound.
* Primary or secondary immunodeficiency.
* History of tuberculosis (TB). Further exclusion criteria apply.
Development of a Questionnaire on Patients' Perception of Their Oncology Care Pathway (Onco-PREMs)

Healthcare systems are evolving, giving increasing prominence to the patient-centered model, accompanied by objective and perceived outcomes.

PREMs (Patient Reported Experience Measures) are used to assess how patients feel about their experience of care. PREMs enable patients to take an active role in their own care, and enable healthcare establishments to identify areas for improvement that can be incorporated into their quality processes.

In oncology, the collection of patient-perceived quality regarding their care pathway would enable better coordination of their care. While a few initiatives have emerged in the field of PREMs, the development of a reliable questionnaire assessing patient perception of their care pathway in oncology remains a challenge.

The aims of the study are to constitute a questionnaire to assess patients' perceptions of their oncology care pathway and to perform its psychometric validation.

Eligibility Criteria:
Inclusion Criteria:

* cancer patient
* regardless of location or stage
* Fluent in French
* aged more than 18 years old
* Agreeing to take part in the study

Exclusion Criteria:

* With an estimated life expectancy of less than 3 months
* In remission, untreated or without follow-up for more than 12 months
* Protected by law
Diafert® for Embryo Selection and Fertility Improvement

Prospective, single-center, single-blind, randomized, controlled, two-arm, interventional study.


Eligibility Criteria:
Inclusion Criteria:

1. Women at least 18 years old at the time of Informed Consent.
2. Able to understand and voluntarily sign an Informed Consent form approved by the relevant Independent Ethics Committee (IEC) governing the site.
3. First or second fresh Assisted Reproductive Technology (ART) cycle attempt (since last successful implantation, if any).
4. Eligible for elective SET of fresh embryo on Day 2/3. Elective SET is defined as a transfer for which there is more than one embryo in the same morphological ("best") category as that of the selected embryo.

Exclusion Criteria:

1. Presence or history of ovarian endometriotic cyst.
2. Presence or history of diagnosed severe endometriosis (i.e. stage IV of the revised American Fertility Society classification for endometriosis).
3. Hormonal, functional, anatomical and/or other abnormalities potentially increasing the risk of miscarriage and/or ectopic pregnancy as judged by the Investigator and determined by medical history and clinical laboratory. This includes, but is not limited to, uncontrolled diabetes mellitus, uncontrolled thyroid disease, alcoholism, drug abuse, abnormal uterine cavity etc.
4. History of two or more consecutive miscarriages.
5. Known history of human immunodeficiency virus, Hepatitis C virus and/or Hepatitis B virus infection.
6. The subject has other serious or acute conditions that, in the Investigator's opinion, would preclude her participation in the study.
7. Need for preimplantation genetic diagnosis/screening.
8. Use of time-lapse embryo imaging
9. Participating in oocyte donation procedure.
10. Participation in any interventional drug clinical investigation within 2 months
11. Dependency on sponsor or investigator (e.g. co-worker or family member).
A Multicenter Study on the Diagnosis and Intervention of New Biomarkers on the Prodromal Stage of Alzheimer's Disease

The prevalence of Mild Cognitive Impairment (MCI) is about 15%-17%. 10%-15% of MCI progresses to Alzheimer's disease (AD) every year. The annual incidence of MCI in the normal elderly is about 1%. is the key and difficult points in AD research. Except expensive brain β amyloid plaque imaging, few breakthroughs of early diagnosis technology of MCI due to AD can be made to facilitate clinical application. The purpose of this program is to study the reliability and validity of plasma miRNAs for early diagnosis of MCI due to AD. The clinical diagnosis of AD and MCI due to AD are according to the National Institute of Aging and the Alzheimer's Disease Association (NIA-AA) diagnostic criteria in 2011. \[18F\]-AV-45 plaque imaging is used to be golden criteria for the diagnosis of AD and MCI due to AD. Next, a pilot intervention study on APP/PS1 transgenic mice will be promoted based on miRNAs gene regulation.


Eligibility Criteria:
Inclusion Criteria:

* 2011 NIA-AA criteria of MCI due to AD or AD

Exclusion Criteria:

* Non AD dementia
OCT Angiography in Wet AMD

The primary goals of this study are to use optical coherence tomography (OCT) angiography (blood vessel mapping) to:

1. diagnose the presence of new blood vessels in wet age-related macular degeneration (AMD)
2. evaluate patients undergoing treatment for wet AMD
3. determine if reduced flow to the choroid is a risk factor for developing wet AMD.


Eligibility Criteria:
Inclusion Criteria (Groups with wet AMD):

* Adults aged 50 and older with clinical findings of treatment-naïve (never treated) neovascular AMD with active new blood vessel growth confirmed by clinical testing will be considered

Inclusion Criteria (Group with healthy eyes)

* No evidence of retinal disease
* Refractive error greater than +3.00 diopters or -7.00 diopters (glasses Rx)
* No recent eye surgery in the last 4 months
* No significant cataract to interfere with the quality of the imaging

Exclusion Criteria (All Groups):

* Inability to give informed consent
* Significant kidney disease
* Blood pressure greater than 180/110
* Previous macular laser treatment
* Inability to maintain stable fixation during OCT imaging
* Visual acuity worse than 20/200
HFNC vs NPPV After Early Extubation for Patients With COPD

High-flow nasal cannula oxygen therapy(HFNC) has proved no significant difference compared with noninvasive positive pressure ventilation (NPPV) in preventing postextubation respiratory failure and reintubation in patients with acute hypoxemic respiratory failure.However, the efficacy of early postextubation sequential HFNC in COPD patients with hypercapnic respiratory failure is inconclusive.

The investigators conducted this prospective randomized controlled trial to explore the efficacy, safety of HFNC versus NPPV after early extubation in COPD patients with hypercapnic respiratory failure.The investigators hypothesized that the efficacy of HFNC after early extubation is non-inferior to that of NPPV.

Eligibility Criteria:
Inclusion Criteria:

* 1. COPD patients with bronchopulmonary infection 2. Patients with hypercapnia respiratory failure treated with invasive mechanical 3.14 days ≥ invasive mechanical ventilation ≥ 48 hours; 4.Reached the pulmonary infection control (PIC) window; 5.Have self-care ability with oxygen supply during stable phrase

Exclusion Criteria:

* Severe organ dysfunction;Myopathy or myasthenia gravis;Upper airway obstruction;A large amount of secretions and inability to drain;
The Air Test: A New Simple, Non-invasive Method to Diagnose Anesthesia-induced Atelectasis

Anesthesia-induced atelectasis persist in the postoperative period but are not usually diagnosed because imaging techniques are required. The aim of the study is to determine whether the value of SpO2≤96 while breathing room air (0.21 FiO2) for 5 min, maneuver that we defined as the Air Test, was able to diagnose atelectasis in the postoperative period after a general anesthesia.


Eligibility Criteria:
Inclusion Criteria:

* ASA I-III
* Scheduled for elective surgery

Exclusion Criteria:

* age of \<18 years
* pregnant women
* previous lung resection
* local-regional anesthesia
* cardio-thoracic anesthesia
* preoperative room air SpO2 less than 97%
Study to Evaluate the Potential for Interaction Between OC000459 and CYP 450 3A4

This will be an open label, sequential study of midazolam (dose 5 mg orally) followed by midazolam (5 mg orally) given after dosing with OC000459 100 mg twice daily for 6.5 days. Twenty subjects will be included to ensure at least 16 subjects with analysable PK data. PK sampling for midazolam and 4-hydroxymidazolam plasma concentrations will continue for up to and including 24 hours after dosing with midazolam on both occasions.


Eligibility Criteria:
Inclusion Criteria:

* Judged to be in good health at screening (blood tests, physical examination, medical history)

Exclusion Criteria:

* Evidence of a clinically significant underlying medical condition that in the opinion of the Investigator would represent a risk to study participation.
Study of VSN16R for the Treatment of Spasticity in Multiple Sclerosis

Phase II a Proof of concept study in Multiple Sclerosis (MS) patients with spasticity.

Single dose escalation followed by multiple fixed dose administrations to assess short term safety and to determine whether spasticity improves.

Eligibility Criteria:
Inclusion Criteria:

* Have a confirmed diagnosis of MS
* Have an Expanded Disability Status Scale (EDSS) ≤ than 6.5 at screening.
* Spasticity due to MS of at least 3 months duration with minimum mean score of \>/=2 mASH

Exclusion Criteria:

* Acute MS relapse requiring treatment with steroids within 30 days of screening.
* Initiation or discontinuation of MS disease modifying treatment (DMT) within 30 days of screening.
* Receiving medications that would potentially interfere with the actions of the study medication or outcome variables
* Significant renal and hepatic abnormalities
* Previous history of other significant medical disorders
Sinew Acupuncture for Neck Pain: Randomized Controlled Trial

The study aims to examine the efficacy and safety of sinew acupuncture for chronic mechanical neck pain (CMNP).

Objectives:

Sinew acupuncture is a superficial needling technique with the advantage of minimal pain, feasible manipulation, and no apparent adverse effects. The proposal aims to examine the efficacy and safety of sinew acupuncture for chronic mechanical neck pain (CMNP).

Hypothesis to be tested:

Sinew acupuncture can reduce pain intensity, and improve neck pain disability and health-related quality of life without significant side effects for CMNP subjects compared to a sham acupuncture treatment.

Design:

A randomized, subject- and assessor-blind, sham acupuncture-controlled clinical trial

Participants:

Subjects (N=130) will be randomized into sinew acupuncture or sham acupuncture group (in 1:1 ratio).

Study instrument:

Visual Analog Scale (VAS), Northwick Park Neck Pain Questionnaire (NPQ) and Short Form-36 (SF-36)

Intervention:

Sinew acupuncture group will receive five sessions of needling in two weeks. Sham group will receive the non-invasive treatment with the same procedures. All subjects are followed up for 4 weeks.

Main outcome measures:

VAS for neck pain intensity at week 3 serves as the primary outcome. VAS at other time points, NPQ score and SF-36 at week 1, 2, 3, and 6, and adverse events are analyzed as the secondary outcomes.

Data analysis:

Analysis will be on the 'intention to treat' principle. T-test and mixed-effect model analysis will be used to measure primary and secondary outcomes respectively.

Expected results:

Five sessions of sinew acupuncture treatment can significantly reduce neck pain intensity, and improve neck pain disability and quality of life without obvious side effects.

Eligibility Criteria:
Inclusion Criteria:

* (1) aged 18 years or above; (2) able to read and write Chinese; (3) the pain is located between the neck and shoulder regions and movement or palpation of the cervical region provokes the symptoms (18); (4) the pain has persisted for more than 3 months; (5) VAS (0 to 100 mm) pain score is ≥30 mm at baseline assessment; (6) no treatments (Chinese medicine, acupuncture, moxibustion, physiotherapies, medications, etc) intended for pain management have been received within the preceding two weeks.

Exclusion Criteria:

* (1) a history of fracture or surgery to the neck; (2) malignant tumor; (3) cervical congenital abnormality; (4) a severe psychiatric illness; (5) needle phobia; (6) acupuncture treatment in the preceding 3 months, and (7) other acupuncture contraindications as indicated in Hospital Authority Guideline on Safety in Acupuncture for Chinese Medicine Practitioners (Quality and Risk Sub-Committee, Hospital Authority, 2010).
Treatment of Disruptive Behaviors in Fragile X Syndrome

Disruptive behaviors such as self-injury, aggression, and property destruction pose significant health-related issues to children diagnosed with fragile X syndrome (FXS), impacting the child's quality of life and causing significant distress to families.

Access to appropriate treatment for families is severely limited by factors such as cost of care, shortages of qualified treatment providers, and geographic spread of children with FXS across the country. To address these potential issues, the effectiveness of administering a standardized function-based behavioral treatment for problem behaviors in FXS will be evaluated using telemedicine. The proposed study intervention therefore offers a tremendous step forward in clinical research both in the field of FXS and in the field of developmental disabilities more broadly, and thus will have a significant impact on public health.


Eligibility Criteria:
Inclusion Criteria:

1. Child has a confirmed diagnosis of FXS (\>200 CGG repeats on the FMR1 gene with evidence of aberrant methylation)
2. Child is male, between the ages of 3-10 years old
3. Child is reported to show self-injury, property destruction and/or aggression on at least a daily basis
4. The caregiver agrees to keep any therapies that the child receives (i.e., medications or other treatments) as stable as possible throughout involvement in the study
5. The family has a high-speed internet connection at home or lives in an area with 4G network coverage
6. Availability for one-hour daily telemedicine treatment sessions
7. Availability for in-home assessment totaling 8 hours across two consecutive days

Exclusion Criteria:

1. The child or caregiver has significant sensory impairments (e.g., blindness or deafness)
2. Non-English speaking
3. The child receives Applied Behavior Analysis services in excess of five hours per week
4. The child has a significant neurological condition (e.g., frequent seizures, brain injury, Tourette's syndrome) that would preclude participation
5. The child or caregiver has significant mobility issues
6. The child is currently participating in another research study that would preclude participation in the study
Measurement of Retinal Blood Flow, Retinal Oxygenation and Retinal Oxygen Extraction in Healthy Subjects During Normoxia and Systemic Hyperoxia

The inner retina is crucially dependent on an adequate retinal blood supply. When the retina becomes ischemic and hypoxic this results in severe vision loss due to retinal neovascularization. Measurement of retinal blood flow and retinal oxygenation is, however, still a difficult task. Information on retinal oxygenation is almost unavailable from human studies. In the present protocol the investigators propose a procedure allowing for the measurement of retinal blood flow, retinal oxygenation and retinal oxygen extraction by combining a number of innovative techniques. Specifically, retinal vessel diameters will be measured with a Retinal Vessel Analyzer, retinal blood velocities with bi-directional laser Doppler velocimetry and retinal oxygenation with spectroscopic evaluation of retinal fundus images. This will allow for the calculation of retinal oxygen extraction, a fundamental parameter of retinal function. Up to now, no data for retinal oxygen extraction are available in the literature.


Eligibility Criteria:
Inclusion Criteria:

* Men and women aged between 18 and 35 years
* Nonsmokers
* Body mass index between 15th and 85th percentile
* Normal findings in the medical history and physical examination unless the investigator considers an abnormality to be clinically irrelevant
* Normal laboratory values unless the investigator considers an abnormality to be clinically irrelevant
* Normal ophthalmic findings, ametropia \< 3 Dpt

Exclusion Criteria:

* Regular use of medication, abuse of alcoholic beverages, participation in a clinical trial in the 3 weeks preceding the study
* Treatment in the previous 3 weeks with any drug except oral contraceptives
* Symptoms of a clinically relevant illness in the 3 weeks before the first study day
* Blood donation during the previous 3 weeks
* Pregnancy