cyrilzakka/clinical-trials huggingface dataset:
The Study of Human Atherosclerosis by Polarization-Sensitive Optical Coherence Tomography

Atherosclerosis is unquestionably the leading cause of morbidity and mortality in developed countries, and the world-wide importance of acute vascular syndromes is increasing. Rupture of atherosclerotic plaque has been identified as the proximate event in the majority of cases of acute ischemic syndromes. Therefore, modalities capable of characterizing the atherosclerotic lesion may be helpful in understanding its natural history and detecting lesions with high risk for acute events.

Optical coherence tomography (OCT) is a powerful tool capable of tomographic imaging based on low coherence interferometry. It is analogous to ultrasound imaging except that it uses infrared light instead of sound. Polarization-sensitive optical coherence tomography (PS-OCT) combines the advantages of OCT with additional image contrast of the sample. The added contrast is based on the ability of PS-OCT to detect the birefringent properties of a sample (phase retardation and fast-axis orientation) simultaneously.

The goals of this project are: 1) to examine whether PS-OCT is an acceptable tool for the characterization of typical plaque constituents; and 2) to explain the correlation between birefringence and forming or rupture of a plaque; and 3) to establish a quantitative PS-OCT image criteria for atherosclerotic plaque characterization in vitro.

Optical Coherence Tomography (OCT) is a promising new class of diagnostic medical imaging technology that utilizes advanced photonics and fiber optics to obtain images and tissue characterization on a scale never before possible within the human body. OCT combines the principles of ultrasound with the imaging performance of a microscope and a form factor that is familiar to clinicians. Whereas ultrasound produces images from backscattered sound "echoes," OCT uses infrared light waves that reflect off the internal microstructure within the biological tissues.

Eligibility Criteria:
Inclusion Criteria:

* Heart transplantation, atherosclerosis

Exclusion Criteria:

* Infection
Effectiveness of Levonorgestrel-intrauterine System (LNG-IUS) Versus Depot Medroxyprogesterone Acetate (DMPA) in Treatment of Pelvic Pain in Clinically Diagnosed Endometriotic Patients

The primary objective : To compare effectiveness of pain control in endometriosis associated pelvic pain between LNG-IUS and DMPA The secondary objective : To compare vaginal bleeding pattern, side effect, continuation rate, satisfaction and quality of life between LNG-IUS and DMPA in treatment of endometriosis associated pelvic pain

The participants were randomized into two treatment groups, by Block Of Four method, LNG-IUS and DMPA group. For the patients in the LNG-IUS group, a LNG-IUS (Mirena) was inserted. The system released the active ingredient LNG for up to five years at a virtually constant rate. For the patients in the Depot MPA Group, 150 mg depot MPA was given intramuscularly once every three months.

All participants were recieved the individual calendars to record all vaginal bleeding occured during treatment. The amount of bleeding was described relative to normal menstruation of each patient; less than, same as, more than their baseline menses. To use easily, we assigned the symbols to represent quantity of vaginal bleeding as described. Each symbol was recorded every day except no bleeding, which was represented with blank space in the calendar. The bleeding pattern were assessed as bleeding rating score; less than normal menses = 1, same amount of normal menses = 2, more than normal menses = 3. No bleeding was defined as 30 consecutive days with bleeding score 0. The mean bleeding score was calculated by sum of the daily scores in each month period.

Follow-up visits were scheduled three times at months 1, 3 and 6 after initial treatment. At each visit, VAS and bleeding pattern was recorded. Side-effects of the two therapies were checked. Patients were allowed to choose to withdraw from their designated therapy at any time. The follow-up was completed in May 2016 for the last patient.

At the final visit, 6 months after treatment, all participants in both treatment groups were recorded the datas of blood pressure, body weight, transvaginal ultrasonography, lipid profiles and SF-36 quesionaires. In addition, all50 patients were asked whether they want to continue in the given treatement and the reason of discontinuation including the satisfaction scores during therapy were rated as 1-5 Likert-scale; 1-very dissatisfied, 2- dissatisfied, 3-neither satisfied/dissatisfied, 4-satisfied, 5-very satified.

Eligibility Criteria:
Inclusion Criteria:

* age 18-45year Pelvic pain VAS\>50 Previous Sexual intercouse

Exclusion Criteria:

* other genital tract disease causing pelvic pain Previous hromonal treament 3 month History of DMPA treatment failure WHO eligibility criteria 2009 categorized in 3-4 for DMPA and LNG-IUS user Fertility desire within 1 year Psychoneurosis Pregnant and breast fed women
Evaluation of Marginal Integrity of Hydroxyapatite Nano-Fiber Reinforced Flowable Composite Versus Conventional Resin-Based Flowable Composite in Initially Demineralized Pits and Fissure: A One Year, Randomized Clinical Trial

This study will be conducted to evaluate the Marginal integrity of Hydroxyapatite Nanofiber reinforced flowable composite compared to a conventional resin-based flowable composite during management of initial carious lesion in adult population over a one year period.

A total of 26 volunteer patients with at least 2 non-cavitated molar teeth will be assigned in this study. Patients will be divided into two groups according to type of flowable composite (R) where groups R1 the pits and fissure will be sealed with Hydroxyapatite Nanofiber reinforced flowable composite while groups R2 the pits and fissure will be sealed with conventional resin-based flowable composite. Each restoration will be assessed after one week, six and twelve months Both materials will be applied according to manufacturer's instructions where teeth should be cleaned to remove surface stains, then select appropriate shade of the flowable composite, A rubber dam is the preferred method of isolation, etch and rinse adhesive system is applied, where acid etching will be applied for 15 seconds then rinse and dry followed by application of adhesive then light cure 10 seconds, then place and cure in 2 mm increments of the flowable composite for 20 s., gently remove oxygen inhibition layer after light cure with slurry of pumice or polishing paste All restorations were reviewed after 1 week, 6, 12 months by two investigators who were blinded to the material used for the restorations. All restorations were be evaluated by calibrated examiners following the FDI criteria

Eligibility Criteria:
Inclusion Criteria:

* Patients should be over 18 Years old.
* Patient should have good oral hygiene and general health
* With at least 2 non-cavitated initial occlusal carious lesion first and/or Second molar teeth in each quadrant of maxilla or mandible

Exclusion Criteria:

* Known allergy to any of the resins used,
* Clinically detectable caries,
* Previously placed sealants or restorations,
* Bruxism or malocclusion
Are There Differences in Postoperative Pain Between Bupivacaine and Lidocaine for Carpal Tunnel Release?

The goal of this clinical trial is to compare the use of bupivacaine and lidocaine as local anesthetics in carpal tunnel release surgery. The main questions it aims to answer are:

* Are there any differences in pain after surgery?
* Are there any differences in postoperative analgesic consumption?

The Wide-Awake Local Anesthesia No Tourniquet (WALANT) technique has become popular for hand surgery in the past decade. It consists of injecting a local anesthetic and epinephrine into the surgical site. Lidocaine, a short-acting local anesthetic, is used in the classic description. Adding a long-acting local anesthetic, such as bupivacaine, has been suggested for long surgeries.

However, the use of bupivacaine in shorter-duration procedures could combine the advantages of ambulatory surgery without a tourniquet with long-acting analgesia, improving postoperative pain and reducing the consumption of analgesics.

Patients undergoing first-time open carpal tunnel release surgery will be randomized to receive bupivacaine or lidocaine. Randomization will be generated by computer using random block sizes of 2 or 4 with an allocation ratio of 1:1.

Postoperatively, patients will receive standard medical care. It consists of 50 mg of diclofenac to take when they feel pain (with a minimum interval of 8 hours). Patients will be instructed to complete a medication log for pain and analgesic consumption. A blinded investigator will contact them by phone at 24 hours and 48hs. At two weeks, they will be controlled by research staff for complications.

Eighty-two patients will be recruited, 41 per arm, assuming a 20% loss. The sample size was calculated using a 90% power and 5% significance level. The objective was to detect a minimum difference of 2 points on a numeric scale ranging from 0 to 10 with a standard deviation of 2.5 points.

Eligibility Criteria:
Inclusion Criteria:

* Patients with carpal tunnel syndrome undergoing first-time surgery

Exclusion Criteria:

* Pregnant
* End-stage kidney disease
* End-stage liver disease
* Allergy to bupivacaine, lidocaine or diclofenac
* Carpal tunnel revision surgery
* Associated surgery (e.g., trigger finger release)
* Unable to understand informed consent or indications
* Patients with anxiety related to surgery who explicitly prefer to be sedated or asleep during their surgery
* Preoperative American Society of Anaesthesiology (ASA) scale ≥3
Effectiveness of Rice Germ Supplementation on Body Composition, Metabolic Parameters, Satiating Capacity and Amino Acid Profiles in Obese Postmenopausal Women

Rice germ (RG) may be a safe and effective dietary supplement for obesity in menopause, considering its high protein content and considerable amounts of essential amino acids, good fatty acids, and fiber. This pilot randomized, blinded, parallel group, placebo-controlled pilot trial investigated the effectiveness of four weeks of RG supplementation (25 g twice a day) on body composition, measured by Dual Energy X-Ray Absorptiometry (DXA), as primary outcome, and metabolic parameters, amino acid profiles and satiating capacity, as secondary outcomes, in obese postmenopausal women following a tailored hypocaloric diet (25-30% less than daily energy requirements). Twenty-seven women were randomly assigned to the supplemented group (14) or placebo group (13). There was a significant interaction between time and group for body mass index (BMI) (p\<0.0001), waist (p=0.002), and hip circumference (p=0.01), total protein (0.008), albumin (0.005), Homeostasis Model Assessment index (p=0.04), glycine (p=0.002), glutamine (p=0.004), and histidine (p=0.007). Haber's means over time showed a clearly greater feeling of satiety for the supplemented compared to the placebo group. These findings indicate that RG supplementation in addition to a tailored diet counterbalanced the metabolic changes typical of menopause, with improvements in BMI, body composition, insulin resistance, amino acid profiles and satiety.


Eligibility Criteria:
Inclusion Criteria:

* obesity (BMI 30-40 kg/m2)
* age 50-65
* menopause
* sedentary women and non-smoking,
* women who did not drink more than six glasses (one glass: 125 mL) of wine a week and did not drink hard liquor (alcohol content at least 20% alcohol by volume)
* women who agreed not to take part in any other weight loss program

Exclusion Criteria:

* evidence of heart, kidney or liver disease
* women who met the Diagnostic and Statistical Manual-IV (DSM-V) criteria for a current diagnosis of major depressive disorder
* taking any medications for weight loss
* control of cholesterol and triglycerides for anti-inflammatory purposes
* pregnancy
* lactating
* Type 1 diabetes mellitus, irritable bowel disease, celiac disease, chronic pancreatitis
* antibiotic use in the last three months
* probiotic/prebiotic treatment in the last four weeks.
Efficacy of Coordinated Insulin Boluses in Type 1 Diabetic Patients

A recent study suggests that, in Type 1 Diabetes (T1D) patients treated by insulin pumps, a better coordination of meal boluses and post prandial basal rate could reduce the importance of postprandial hyperglycaemias without increasing the risk of delayed hypoglycaemias.

The aim of the investigators study is to assess if these results are confirmed in a clinical trial.

The aim of this study is to compare the efficacy of coordinated boluses versus normal boluses on postprandial glycaemic control of T1D patients treated with continuous subcutaneous insulin infusion.


Eligibility Criteria:
Inclusion Criteria:

* Type 1 diabetes mellitus
* with confirmed Negative C-peptide or diabetes duration\>5 years
* Treated by external insulin pump and rapid insulin analog for more than 3 months
* using a Medtronic Paradigm Real-Time or Veo™ model
* Educated to and practicing functional insulin treatment and carbohydrate counting for more than 3 months
* Able to use the "basal temp" and "glycaemia reminder" functions of their pump
* Basal infusion rate ≥ 0,5 Unit/h
* Self-monitoring of blood glucose frequency \> 4/days
* Aware of hypoglycaemia

Exclusion Criteria:

* known impaired renal function (creatinin clearance \<60ml/min)
* Gastroparesis
* Serious or instable disease likely to induce a glycaemic control deterioration - treatment with corticosteroids
A Long-term Study to Evaluate Safety and Maintenance of Treatment Effect of LY3074828 in Participants With Moderate-to-Severe Plaque Psoriasis (OASIS-3)

The purpose of this study is to evaluate the long-term safety and maintenance of efficacy of mirikizumab in participants with moderate-to-severe plaque psoriasis.


Eligibility Criteria:
Inclusion Criteria:

* Participant must have completed the last visit of an eligible study period of originating study.
* Participant must be willing to follow the birth control measures during and after study treatment if woman of childbearing potential.

Exclusion Criteria:

* Participant must not have an unstable or uncontrolled illness, including but not limited to a cerebro-cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematologic, or neurologic disease or abnormal lab results, that the study investigator thinks makes it unsafe or inappropriate for the participant to participate in this study.
* Participant must not have stopped taking mirikizumab during a previous study or if the study investigator thinks restarting mirikizumab would create an unacceptable risk to the participant.
A Study to Evaluate the Effect of VX-661 in Combination With Ivacaftor on Chest Imaging Endpoints in Subjects With Cystic Fibrosis, Homozygous for the F508del CFTR Mutation

The primary purpose of study is to evaluate the treatment effect of tezacaftor in combination with ivacaftor (TEZ/IVA) on chest imaging endpoints using low-dose computed tomography (LDCT) at Week 72, and to evaluate the safety of TEZ/IVA through Week 72.


Eligibility Criteria:
Inclusion Criteria:

* Homozygous for the F508del CFTR mutation
* Confirmed diagnosis of CF
* Percent predicted forced expiratory volume (ppFEV1) ≥70% of predicted normal for age, sex, and height during screening.
* Stable CF disease as judged by the investigator

Exclusion Criteria:

* History of any comorbidity that, in the opinion of the investigator, might confound the results of the study or pose an additional risk in administering study drug to the subject.
* An acute upper or lower respiratory infection, pulmonary exacerbation, or changes in therapy (including antibiotics) for pulmonary disease within 28 days before Day 1 (first dose of study drug)
* Pregnant or nursing females.
* Sexually active subjects of reproductive potential who are not willing to follow the contraception requirements.
* Any contraindication to undergoing chest imaging, as per the site's institutional guidelines
64Cu-LLP2A for Imaging Multiple Myeloma

The investigators are performing a trial with goals to demonstrate the feasibility of imaging multiple myeloma (MM) patients with 64Cu-LLP2A-positron emission tomography (PET)/magnetic resonance (MR). The investigators suggest that 64Cu-LLP2A will allow for an accurate molecular imaging of MM lesions, which will have an important impact on early stage disease detection and in the long term on the initiation and choice of therapy in these patients.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients 18 years of age or older with clinically or pathologically defined MM in accordance with International Myeloma Working Group or as stated in office note / clinical assessment from treating physician.

  \*All types of active myeloma are eligible including both newly diagnosed and previously treated provided plans are to start a new treatment or restart a prior treatment.
* Healthy Volunteer Subjects: Adult 18 years of age or older with no known hematologic disorder such as anemia, leukemia, etc. who is considered healthy based on assessment by PI. (Cohort 1 only).
* Able to give informed consent.
* Does not have any exclusions related to PET/MR imaging: No implanted medical devices such as: pacemaker, defibrillator, neurostimulator, artificial heart valve, cerebral aneurysm clips, no accidental exposure to metal fragments (if applicable)
* If applicable for administration of contrast with MRI imaging subject must have a calculated GFR of at least 60 mg/mL/1.73 m\^2.
* Not currently pregnant or nursing: Subject must be surgically sterile (has had a documented bilateral oophorectomy and/or documented hysterectomy), post-menopausal (cessation of menses for more than 1 year), non-lactating, or of childbearing potential for whom a urine pregnancy test (with the test performed within the 24 hour period immediately prior to administration of 64Cu-LLP2A) is negative.

Exclusion Criteria:

* Patients with other invasive malignancies, with the exception of non-melanoma skin cancer, who had (or have) any evidence of the other cancer present within the last 5 years.
* Unable to tolerate up to 90 min of PET/MR or PET/CT imaging per imaging session.
Fatigue and Inspiratory Muscles Training in Patients With Multiple Sclerosis

The purpose of this study is to assess the effect of a training of the inspiratory muscles against resistance at home during 10 weeks in multiple sclerosis patients with a severe disability.

Patients will be informed about the study procedures during a follow-up consultation or an hospitalization in a Physical and Rehabilitation Medicine Unit. If they give their informed consent to participate in the study, an investigator will randomize them into one of the 2 arms of the study. This study consists of 3 visits. The first visit (inclusion) is planned at day 0, the second visit 10 weeks later and the third 3 months after day 0. A patient who is randomized in the experimental arm will have to follow 10 weeks of rehabilitation of the inspiratory muscles at home between first and second visit. During this period, investigators will call these patients once a week to assess the compliance with the rehabilitation. The patients who have been randomized in the control group will not follow this rehabilitation program.

Eligibility Criteria:
Inclusion Criteria:

* Patient with remitting or progressive multiple sclerosis defined by McDonald criteria revised in 2005, with an EDSS between 6 and 7,5
* Aged between 18 and 65 years
* Patients able to maintain the Powerbreathe
* Not to have had a flare-up since at least 6 weeks
* Patients at least 4 weeks since a corticoid bolus
* Patients at least 6 weeks since a botulinum toxin injection
* Patients at least 4 weeks since a pulmonary infection
* Questionnaire EMIF-SEP \>= 55
* Patients given their informed consent
* Patients who benefit or are affiliated to a social security regimen

Exclusion Criteria:

* Patients with neurologic antecedents other that multiple sclerosis
* Patients with respiratory disorders other than those induced by multiple sclerosis
* Patients with orthopedic, cardiac, and rheumatologic invalidating antecedents
* Patients with comprehension or cognitive disorders impeding the realization of rehabilitation
* Pregnant women
* Patients under legal guardianship, or safeguard of justice
* Patients participating or planning participate within the 3 months of the study to another clinical research project
Prediction Model of Treatment Efficacy for Age-related Macular Degeneration Based on Multi-source Imaging Modalities

Age-related macular degeneration (AMD) is one of the main causes of blindness in the elderly population. Intraocular injection of anti-VEGF drugs for neovascular AMD (nAMD) is the main treatment method at present. However, patients have different responses to anti-VEGF therapy, and some patients do not respond well to short - and long-term treatment.

In this study, a retrospective study was adopted to collate and analyze the clinical data and imaging data of nAMD in the past, and to extract the imaging features from the multimodal modalities before and after treatment for deep learning, and to evaluate and quantify the clinical features, and to construct two multi-source feature models for predicting the short-term and long-term prognosis of nAMD patients. By verifying the accuracy of the model to predict the curative effect, the classification efficiency of the above characteristic models was compared, and the optimal model was selected. Its clinical application value was evaluated by calibration curve and decision curve. In addition, patients with poor treatment response in the study cohort were retrospectively analyzed, and the efficacy and safety of the combination of other treatment options in the actual clinic were analyzed. The purpose of this study is to provide scientific basis for early prediction, dynamic monitoring and optimization of overall treatment strategies for nAMD.


Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with nAMD by ophthalmic examinations including OCT, OCTA, FFA and ICGA;
* Complete clinical data and imaging data of patients were available at baseline, 3 months and 1 year after anti-VEGF treatment.

Exclusion Criteria:

* Medical records showed other diseases affecting visual function or fundus imaging, such as macular edema, glaucoma, ocular trauma, etc;
* Medical records showed that two or more macular lesions coexist in the affected eye;
* Medical records showed that patients received other treatments within 1 year of anti-VEGF therapy, such as intraocular laser therapy or ocular surgery;
* Medical records showed that there were ocular media opacity, dense macular hemorrhage, or severe macular atrophy, resulting in the inability to accurately measure the required parameters;
* Medical records showed the use of drugs known to cause retinal toxicity, or a history of radiation exposure.