cyrilzakka/clinical-trials huggingface dataset:
Dynamic Light Scattering to Study Crystalline Proteins in Young Normal Lenses

This study will use a method called dynamic light scattering (DLS) to study the lens of the eye in young normal subjects. The DLS device uses a very dim laser light to study the lens of the eye. It detects proteins in the lens, identifying early changes that may make the device useful in future cataract studies. This study will use DLS to examine the characteristics of proteins in healthy young lenses that can be used for comparison with lenses in older people and people with cataracts.

Normal volunteers aged 5 to 21 years may be eligible for this study. Participants undergo the following procedures:

Medical history

Eye examination with dilation to include:

* Measurement of visual acuity
* Examination of pupils and eye movements
* Examination of the front of the eye (cornea, lens) with a slit lamp bio-microscope
* Examination of retina with an ophthalmoscope (instrument with a strong light and magnifying lens)
* Dynamic light scattering

The NASA-NEI Dynamic Light Scattering (DLS) device detects early molecular lens changes before clinical means are able to detect any lens changes in animal and limited human studies. This ability will make it very useful in future clinical studies of cataract etiology as well as treatment. A recently concluded clinical cross sectional study of lenses (in vivo) using the DLS device showed good reproducibility and good correlation with clinical cataract grading. It also detected remarkable changes in the lens crystalline proteins with aging and with cataract formation. We therefore propose to study the characteristics of the crystalline proteins in pristine young normal lenses with DLS for comparison with aging and cataractous lens findings. We will examine 30 young normal subjects, perform undilated eye examinations, and obtain DLS measurements of their lenses. We will then use these DLS measurements for comparison with the previously obtained aging and cataract DLS measurements, to obtain normative data for future lens and cataract clinical studies.

Eligibility Criteria:
* INCLUSION CRITERIA

The study will enroll 30 normal control subjects, aged 5-21 years. Eligible participants must have normal clear lenses as determined by the eye examination.

EXCLUSION CRITERIA

Individuals who cannot cooperate or keep still for the DLS measurements will be excluded.
Paclitaxel Coated PTA Balloons for Treatment of Dysfunctional AV Fistulae and Grafts

The purpose of this study is to evaluate the Lutonix® 035 Drug Coated Balloon PTA Catheter (CE mark) for use as intended in the treatment of subjects with clinically significant hemodialysis vascular access stenosis or occlusion.


Eligibility Criteria:
Inclusion Criteria:

1. Age ≥18 years
2. The subject is legally competent, has been informed of the nature, the scope and the relevance of the study, voluntarily agrees to participation and the study's provisions, and has duly signed the informed consent form (ICF)
3. Hemodialysis access on the arm presenting with any clinical abnormalities as defined in the K/DOQI guidelines
4. Native AV fistula or synthetic AV graft has been implanted ≥30 days
5. Target de novo or non-stented restenotic lesion(s) consisting of a \>50% stenosis by visual estimate. Successful treatment of non target lesion(s) (residual stenosis \<30% by visual estimate) without procedural complication by standard of care
6. Successful predilatation of the target lesion with a percutaneous transluminal angioplasty (PTA) balloon
7. Intended target lesion(s) (maximum of 2) can be treated
8. No other prior surgical or vascular interventions within 2 weeks before and/or planned 30 days after the treatment

Exclusion Criteria:

1. Women who are pregnant, lactating, or planning on becoming pregnant or men intending to father children
2. Known contraindication (including allergic reaction) or sensitivity to contrast media, ASA, clopidogrel, ticlopidine, paclitaxel (mild to severe cases), that cannot be adequately managed with pre-and post-procedure medication
3. Life expectancy \<12months
4. Scheduled for kidney transplant or peritoneal dialysis in the next 12months;
5. Thrombosed access
6. Stent in the target treatment area
7. Blood coagulative disorder, sepsis, or current AV access infection
8. Currently participating in an investigational drug, biologic, or device study, or previous enrollment in this study NOTE: Enrollment in another investigational drug, biologic, or device study during the follow- up period is not allowed
Effects of Painful Compared to Painless Manual Therapy on Pain Processing in University Students With Neck Pain

The purpose of this study is to evaluate the effects of provoking pain with manual therapy on pain processing in university students with recurrent or chronic neck pain.

The mechanical stimulus produced in manual therapy (MT) techniques elicits neurophysiological responses within the peripheral and central nervous system responsible for pain inhibition. Almost all types of MT elicit a neurophysiological response that is associated with the descending pain modulation circuit. But it has not been demonstrated whether this inhibition occurs through a conditioned pain modulation mechanism generated by the pain that manual therapy techniques may elicit in the patient.

Eligibility Criteria:
Inclusion Criteria:

* University students
* Chronic neck pain (persistent pain \> 3 months almost every day of the week) or recurrent neck pain (repeated episodes of neck pain starting \> 3 months ago with pain-free periods)
* Non-specific neck pain (pain in the neck region that is not attributable to a known specific such as herniated disc, myelopathy, fractures, spinal stenosis, neoplasm etc. nor is it associated with traumatic causes such as whiplash)
* Mean NRS score the last week \> 2/10 and presence of pain on the day of assesment and treatment

Exclusion Criteria:

* Signs of radiculopathy or neuropathic pain
* Neck surgeries
* Inflammatory rheumatic
* Neurological, cardiorespiratory, oncological or psychiatric disease
* Pregnancy
* Not being able to read Spanish in order to fill in the questionnaires
A Study of Efficacy, Safety, and Tolerability of KAN-101 in People with Celiac Disease

The study goal is to evaluate the efficacy, safety, and tolerability of KAN-101 in participants with Celiac Disease (CeD)

Study KAN-101-03 is a multi-center, double-blind, placebo-controlled Phase 2a study to examine whether KAN-101 confers protection from gluten exposure induced histological changes in the duodenum and to further evaluate the safety/tolerability of KAN-101 in adult participants (≥18 years) with CeD on a gluten free diet. Approximately 52 participants who meet study inclusion/exclusion criteria will be randomized 1:1 to receive KAN-101 or placebo.

Eligibility Criteria:
Inclusion Criteria:

* Previous diagnosis of celiac disease based on histology and positive celiac serology
* HLA-DQ2.5 genotype
* Gluten-free diet for at least 12 months
* Negative or weak positive for transglutaminase IgA and negative or weak positive for DGP-IgA/IgG during screening
* Screening intestinal biopsy demonstrating Vh:Cd ratio of 2.3 or higher

Exclusion Criteria:

* Refractory celiac disease
* HLA-DQ8 genotype
* Selective IgA deficiency
* Diagnosis of type-I diabetes
* Other Active gastrointestinal diseases
* History of dermatitis herpetiformis
Ocular Sequelae of Patients Hospitalized for Respiratory Failure During the COVID-19 Epidemic

Ophthalmologic damages secondary to COVID-19 coronavirus infection are little described. The ocular involvement is probably multiple, ranging from pathologies of the anterior segment such as conjunctivitis and anterior uveitis to disorders that threaten vision such as retinitis or optic neuropathy. On the other hand, in addition to this impairment, when patients are hospitalized for acute respiratory failure, complications related to possible resuscitation, medication prescriptions, positioning and oxygenation.

COVID-19 itself, has several components:

* An apoptotic action of the viral attack which will generate cellular destruction, whether pulmonary, cardiac or renal or maybe ocular
* A secondary autoimmune action with the development of major vascular inflammation, possibly reaching the retinal, choroidal, and optic nerve vessels. A secondary "hyper" inflammatory syndrome with flashing hypercytokinemia and multi-organ decompensation is described in 3,7% to 4 ,3% of severe cases.
* A thromboembolic action

Upon discharge from hospital for COVID-19 infection (or during a telephone call for patients already discharged at the start of the study), patients will be informed of the study. An ophthalmology appointment will be given to them between 4 and 6 months after their discharge.

During the ophthalmology appointment, the patient's clinical data will be collected during an interview (medical and treatment history, blood group). The patient will benefit from a full ophthalmological examination.

Eligibility Criteria:
Inclusion Criteria:

* Patients having been hospitalized for a confirmed COVID-19 infection (CT-scanner or PCR- Polymerase chain reaction)

Exclusion Criteria:

* Pregnant or breastfeeding woman
Acute Hip Fracture Study in Patients 65 Years or Greater

This is a randomized, double-blind, parallel group, placebo-controlled, multicenter study to investigate the safety, tolerability, and efficacy of VK5211 after 12 weeks of treatment.

Males and females ≥65 years old who are ambulatory and recovering from a hip fracture will be eligible for participation 3-7 weeks post-injury.


Eligibility Criteria:
Inclusion Criteria:

* Males or females ≥65 years old who are recovering from a hip fracture (occurring 3-7 weeks prior) with no residual surgical issues will be eligible for participation.

Exclusion Criteria:

* Pathological fracture (e.g. fracture due to Paget's disease of bone, malignancy, etc.). Fracture due to postmenopausal osteoporosis is not considered pathological for this trial.
Eccentric Cycling Exercise on Hemodynamic and Hemorheologic Properties

The effects of an eccentric endurance training on central and peripheral hemodynamic adaptations and erythrocyte rheology during maximal exercise remained to be unexplored. The current study examined the contribution of rheological functions and/or hemodynamic adaptation to changes in oxygen consumption (VO2) following the matched-power output eccentric (ECT) or concentric cycling training (CCT).

Method: A total of 39 sedentary males were randomly assigned into either CCT (n=13) or ECT (n=13) for 30 min a day, 5 days a week for 6 weeks at 60% of maximal workload or to a CTL (control group, n = 13). A graded exercise test (GXT) was performed before and after the intervention. Central and microvascular adaptations were evaluated using thoracic impedance and near-infrared spectroscopy (NIRS), respectively. Rheological characteristics was determined by an ektacytometer.

Endurance training is a well known strategy for improving fitness capacity. However, some populations are intolerance to complete the usual exercise training program, such as chronic heart or pulmonary disease or the elderly. Therefore, ECT is a candidate training strategy for those individuals.

Erythrocytes deformability is significantly related to the blood perfusion in microcirculation. The impaired erythrocyte-related rheology further lead to reduced aerobic capacity by our research team. Therefore, the lower energy consumed in ECT may avoid the oxidative stress. To now, less studies have demonstrated whether ECT influences peripheral hemodynamics by erythrocyte rheology and the blood flow from the central effect.

The investigators aimed to investigate the effects of CCT and ECT on oxygen consumption response explained by changes in local blood perfusion, blood cell rheology, or central function to attempt developing its application in rehabilitation.

Eligibility Criteria:
Inclusion Criteria:

* in sedentary lifestyle, who were nonsmokers, nonusers of medications/vitamins, and free of any cardiopulmonary/hematological risks

Exclusion Criteria:

* regular exercise habits (i.e., exercise frequency once per week, duration \>20 min).
Risk of Reactivation of Occult Hepatitis B in Cancer Patients During Immunotherapy.

The goal of this observational study is to evalue the cumulative proportion of patients with OBI who do not develop HBsAg seroreversion and/or an increase of serum HBV DNA by at least 1 log above the lower limit of detection of the assay in a patient who had previously undetectable HBsAg and HBV DNA in serum during the study.


Eligibility Criteria:
Inclusion Criteria:

* Life-expectancy (as estimated by treating physician) ≥ 6 months;
* Patients HBsAg negative
* Patients HBcAb positive with or without HBV-DNA detectable
* Patients with cancer undergoing immunotherapy with or without chemotherapy

Exclusion Criteria:

* Patients who did not give informed consent
* Patients under prophylaxis for HBV
* Patients vaccinated for hepatitis B
* Patients with HBsAg positivity
* Patients with HIV positivity
* Patients with current history of alcohol (more than 5 alcohol unit daily) and drug use
* Patients with other cause of liver disease with known etiology (autoimmune liver disorder and storage liver disease)
* Patients with current active Hepatitis C virus (HCV-positive)
* Patients with hepatocellular carcinoma (HCC)
Comparative Evaluation of Two Different Post-Operative Analgesia After Hallux Valgus Correction

Background: Recent studies showed the efficiency of several techniques of anesthesia in foot surgery. The new mini-invasive surgical approaches should require less analgesia and rapid motor recovery after surgery. The aim of this study was the evaluation of two different techniques on postoperative analgesia and motor recovery after hallux valgus correction in one-day surgery patients.

The hallux valgus surgery is often characterized by a significant post-operative pain difficult to control with oral analgesics. Consequently, large doses of parenteral opioids are often required Various nerve blocks (popliteal, saphenous, sciatic) can give excellent post-operative pain control. Among loco-regional anesthesia techniques, the sciatic nerve block provides good post-operative pain relief after foot surgery. Thus, sciatic nerve block with long-acting local anesthetics (with or without a peri-neural catheter) has been recommended as a primary option. This analgesic approach should cause a difficult discharge in ambulatory and one-day surgery patients, due to the prolonged motor recovery and loss of proprioception and protective pain reflexes. Therefore, it would be preferable to use the sciatic nerve block just for intra- operative anesthesia without affecting motor recovery, and to apply multimodal analgesia for post- operative pain management. Hallux valgus repair can now be done percutaneously, a minimally invasive technique called ''mini-invasive hallux valgus repair'', consisting in osteotomies through 3 to 5 mm incisions, without internal fixation. This approach requires less dissection and exposure, determining a smaller inflammatory response and theoretically causing less pain. Ideal anesthesia for these procedures should provide rapid patient recovery, minimal nursing care requirements in the post- anesthesia care unit and an earlier hospital discharge. It must provide effective analgesia, since the foot surgery is known to induce a moderate-to- severe post-operative pain, that represents one of the major limitations to hospital discharge on the day of surgery and is the main cause of re-admission.

The aim of this matched-control study was to evaluate two different techniques of post-operative analgesia after hallux valgus correction in one-day surgery patients.

Eligibility Criteria:
Inclusion Criteria:

* hallux valgus deformity
* pain
* walking difficulty with shoes

Exclusion Criteria:

* peripheral circulatory disorders
* foot skin lesion
* local anesthetic allergy
18F-HER2 PET in Evaluating the Efficacy of Anti-HER2 Therapy for Urothelial Carcinoma.

This is a open-label, one-arm, multicenter study aimed to explore the efficacy and safety of 18F-HER2 PET in Evaluating the Efficacy of Anti-HER2 Therapy for Urothelial Carcinoma.


Eligibility Criteria:
Inclusion Criteria:

1. Informed consent document must be signed.
2. Aged 30-80 years old, both genders.
3. Patients with locally advanced or advanced urothelial carcinoma
4. Patients plan to undergo anti HER2 treatment.

Exclusion Criteria:

1. Subjects with active malignancies other than urothelial carcinoma within 5 years should be excluded.
2. Patients with severe liver, kidney, and hematopoietic diseases
3. Patients with other mental disorders or primary emotional disorders
4. Those who are unable to understand, comply with the research protocol, or sign an informed consent form
5. PET imaging Contraindication (including pregnant women, lactating women, women of childbearing age who have a recent fertility plan, etc.)
6. Individuals who are allergic to imaging agents
7. Hypoglycemic reactions, severe pain, etc. cannot be accompanied by PET scans
Diary for Severe Trauma

Treatment of severe trauma patients includes intensive cares. Both trauma and intensive care may lead to a post-traumatic stress disorder‬ and then to a decreased quality of life. Diaries may improve the frequency and the intensity of PTSD. Aim of investigator is to assess if diaries may improve quality of life after a severe trauma.

Trauma is the third cause of death in France and the first cause of death of people under 40 years (48 000 deaths a year).

Severe trauma defined by an Injury Severity Score ( ISS) \> 15 implies intensive care.

Intensive care unit admission induces considerable psychological distress and memory troubles, both promoting posttraumatic stress disorder (PTSD) and symptoms of anxiety and depression. A diary written prospectively during the ICU stay by the staff and relatives has been suggested as a means of help¬ing patients to build a more detailed and factual narrative of their ICU stay than would be possible based only on their fragmented memories. Garrouste et al. have shown that the intensive care unit diary significantly affected posttraumatic stress disorders in surviving patients 12 months after intensive care unit discharge.

Besides, severe trauma by itself may decrease the quality of life (QoL). It is recommended to assess QoL on one year after the trauma. In trauma patients, the change in QoL is associated with the presence of a PTSD.

Consequently, severe trauma patients who undergo a double stress, that of the accident and that of the intensive care unit stay: they may so even more have a decrease of their QoL by developing a PSTD.

The investigator formulate the hypothesis that a diary, written by the staff and relatives from the very acute phase of the ICU stay (first 48 hours) to the discharge of ICU would improve the QoL and would decrease the frequency and the intensity of PTSD of the severe trauma patients one year after the trauma.

Eligibility Criteria:
Inclusion Criteria:

* all patients over 18
* with severe trauma (Injury Severity Score (ISS) \> 15)
* admitted in our trauma centered and hospitalized in intensive care unit for more than 48 h

Exclusion Criteria:

* non-French language fluent patients
* Patients with dementia
* Hospitalization in intensive care unit less than
* opposition to data utilization
Effectiveness of Internet-Based Self-Help ACT With Behavioral Activation in Improving Alcohol Use Abstinence Among Ethnic Minority Young Adults With Alcohol Use Disorder

The goal of this clinical trial is to examine the preliminary effectiveness and feasibility of internet-based self-help acceptance and commitment therapy with behavioral activation for ethnic minority young adults with alcohol use disorder. The main questions it aims to answer are:

* Is the internet-based self-help acceptance and commitment therapy with Behavioral activation (self-help iACT-BA) feasible and acceptable for ethnic minority young adults with AUD?
* Does the self-help iACT-BA promote greater abstinence from alcohol use compared to treatment as usual (TAU) in ethnic minority young adults diagnosed with AUD? Researchers will compare self-help iACT-BA to treatment as usual (TAU) to see if self-help iACT-BA works to treat alcohol use disorder in ethnic minority young adults.

Participants will:

* Received a self-help iACT-BA module every week for 6 weeks. or a placebo every day for 4 months
* Access the module every week, read the material, practice, and complete home assignments.


Eligibility Criteria:
Inclusion Criteria:

* Hong Kong ethnic minority young adults
* They have to read, write, and speak English
* Their age will range from 18 to 25
* They will be voluntary to participate
* Participants should have smartphones or other electronic devices to access the internet
* They must have AUD based on DSM-5 criteria.

Exclusion Criteria:

* Currently having psychiatric problems, other mental health problems, being actively involved in suicidal attempts, or immediate care
* Having a plan to go out of Hong Kong during intervention implementation
* Having no access to the internet, smart telephone, or other electronic devices
* Have participated in another psychosocial or pharmacological intervention for AUD.
Colchicine Has Anti-diabetic Effect

Colchicine has antidiabetic effect and may be an option for type 2 diabetes management

Observational cohort prospective study with following of 150 newly diagnosed type 2 diabetes patients who were in 3 groups, had been monitored in a private clinic, each group 50 patients number, with 30 females and 20 males after written consent from all patients. The ages of all patients were between 35 and 55 years.

The aim of this study was to evaluate colchicine effect on A1C of newly diagnosed type2 diabetes compared to the metformin and control group on diet only.

The first group patients received colchicine 0.5twice daily for 6 months, the second group received metformin 1gm twice daily, the third group patients were on diet only. During the period of treatment, the investigators followed the patients if there were side effects of the drugs used. No side effects were monitored during the period of treatment except for gastric upset in some patients using metformin

Eligibility Criteria:
Inclusion Criteria:

* type 2 diabetes newly diagnosed age 35- 55 years

Exclusion Criteria:

* severe anemia hypothyroidism and hyperthyroidism moderate to severe liver or kidney disease