cyrilzakka/clinical-trials huggingface dataset:
Structure and Function of Retinal Disease

Current clinical cameras do not allow clinicians to see the cells of the retina. This study will evaluate a new electronic camera's ability to image the human retina in finer detail.

This research study will (1) test the ability of a new electronic camera developed in Dr. Miller's laboratory to collect extremely sharp volumetric images of the retina in human subjects, and (2) use the camera for addressing fundamental questions about how disease progresses in the eye. This new camera integrates cutting-edge technologies in adaptive optics (AO) and optical coherence tomography (OCT) that enable the camera to capture sharp images. However, many aspects of the camera are already employed in clinical instruments used routinely by eyecare practitioners worldwide. The objective of our study is to find out (1) whether the AO-OCT camera will allow researchers to observe and quantify finer detail in the retina than current clinical cameras, and (2) whether this finer detail is useful for understanding the progression of disease in the eye.

To address the second objective, the study will look at two subgroups of retinal disease. The first is age-related macular degeneration (AMD), a leading cause of blindness in the developed world. Because this disease is difficult to study directly as it takes years to progress, we will study it indirectly using subjects with a form of retinal toxicity that exhibits a retinal phenotype similar to that of AMD but progresses on a much faster time scale. The second disease subgroup is inherited retinal degeneration that affects as many as 1 in every 2,000 people worldwide. For this subgroup, the researchers will test the exquisite sensitivity of the AO-OCT imaging system to detect minute changes in disease progression over short periods of time covering weeks and months.

Eligibility Criteria:
Inclusion Criteria:

* Retinal disease of either inherited retinal degeneration or retinal toxicity

Exclusion Criteria:

* Ocular media opacities
* High refractive error
* Pupil dilation imposes a risk to ocular health
Diagnosis of Rectal Cancer by Electromagnetic Device

The aim of the present prospective study was to evaluate the prediction accuracy of electromagnetic detection of rectal cancer (RC). Eligible subjects were consecutively enrolled in the investigators' Institute and subjected to electromagnetic detection followed by colonoscopy and histopathologic analysis of biopsies. A putative RC carrier status was attributed to subjects showing an electromagnetic signal \< 50 units (U).

Eligibility criteria: Gastrointestinal disease or clinical symptoms related to colorectal cancer risk. Exclusion criteria consisted of age younger than 18 years, history of psychiatric illness, and preoperative radiotherapy.

Outcome measures: RC screening was carried out using a Tissue Resonance InterferoMeter probe (TRIMprobe) electromagnetic detector (Galileo Avionica, Turin, Italy), which consists of a nonlinear oscillator placed in a cylindrical probe about 30 cm long, a radiofrequency spectrum analyzer, and dedicated computer software. Detection of RC is based on the decrease of the electromagnetic signal compared to the mean signal obtained in healthy subjects. The test was performed while the patient stood 120 cm from the receiver. The operator was on the opposite side of the examined pelvis. No metallic objects were allowed on the patient and no electronic devices were admitted in the test area. The detector was kept at close contact to the pelvis surface and was moved through six planes, to obtain a scan of the whole pelvis volume. Based on the investigators previous study, we used the electromagnetic detection system at 465 MHz frequency, in a scale from 0 to 255 arbitrary U. The device lets the examination limited to the pelvis and we regarded the rectum cutoff within 15 cm from the anal verge.

Eligibility Criteria:
Inclusion Criteria:

* Gastrointestinal disease or clinical symptoms related to colorectal cancer risk.

Exclusion Criteria:

* Age younger than 18 years, history of psychiatric illness, and preoperative radiotherapy.
Refinement and Testing of Recruitment Methodology for Behavioral Medication Adherence Interventions Using Behavioral Science-based Approaches

The overarching goal of the proposed research is to prepare the clinical pharmacist intervention for sustainable implementation and dissemination. Because the effectiveness of the intervention has already been demonstrated in a NIH Stage Model IV trial, the investigators propose an Effectiveness-Implementation Type 3 Hybrid design, in which the primary focus is on testing different implementation methods, while secondarily observing clinical effects. The investigators' overarching hypothesis is to identify the most impactful elements of a behavioral theory-informed recruitment approach, which can be replicable across clinical settings.

Accordingly, the investigators propose to perform testing of a behaviorally-informed recruitment approaches in a community-based setting. Like the previous Tele-Pharmacy Intervention to Improve Treatment Adherence (STIC2IT) trial (NCT02512276), participants will be English or Spanish speaking adults ≥18 years of age identified through the electronic health record (EHR) as having poor disease control and/or poor medication adherence for diabetes. The primary care physicians of eligible patients identified through the EHR will be contacted to opt-out any patients they wish not to be included. Patients will then be randomized to each of the following conditions, such that there will be 8 total arms: (1) inclusion of a mailer primer (yes/no), (2) the most successful recruitment letter from the preliminary study using prospect theory (versus the control letter), and (3) intensity of the intervention outreach (4 calls vs. 2 calls). The investigators plan to enroll 584 participants who meet the inclusion criteria, with 73 patients per each of the 8 study arms.

Patients across all arms who agree to be scheduled will receive an appointment with one of the clinical pharmacists within the established BMC pharmacist program. The primary outcome will be completion of a clinical pharmacist appointment within 8 weeks after randomization. Key secondary outcomes will include scheduled visit rates, no-show rates for scheduled appointments, medication adherence over the 3-month follow-up, and clinical outcomes, including HbA1c levels measured using EHR data in the 3 months after randomization. The medication adherence and clinical outcomes will be used for the Aim 2 evaluation.


Eligibility Criteria:
Inclusion Criteria:

* ≥18 years of age
* English or Spanish speaking
* Receiving care from a BMC primary care provider
* Non-adherent to prescribed oral glucose-lowering medications as per pharmacy dispense records (proportion of days covered \<80% to at least one eligible medication in last 6 months)
* Evidence of poor or worsening disease control

Exclusion Criteria:

* Evidence of terminal conditions
Pilot Study to Improve Therapeutic Outcomes for Dysphagia After Radiation Therapy

Patients with head and neck cancer treated with chemoradiation, often develop a treatment associated dysphagia. The common complaint is foods sticking in the pharynx. This study seeks to test the Iowa Oral Performance Instrument (IOPI) in the management of treatment induced dysphagia following chemoradiation for oral, pharyngeal, laryngeal, hypopharyngeal cancer. This pilot study seeks to compare standard exercise therapy plus IOPI to standard exercise alone to determine if recovery is enhanced and to determine if rate of recovery is accelerated.


Eligibility Criteria:
Inclusion Criteria:

* diagnosed with oral, oropharyngeal, hypopharyngeal or laryngeal cancer having non-surgical treatment with chemoradiation, or radiation therapy alone, resulting in treatment associated dysphagia.

Exclusion Criteria:

* unable to adhere to assigned therapy program due to cognitive deficits
* surgical treatment for head and neck cancer
* unable to give informed consent
Integral Single-cell Landscape of Immunological Hallmarks for Ankylosing Spondylitis

Three HLA-B27-positive health donors (HDs) with matching age were enrolled via genetic screening, and fourteen AS patients were recruited at Fujian provincial hospital from May to July 2021. All AS patients satisfied the modified New York (NY) criteria, and the categorization of three disease groups (EA, LD and RM) was according to clinical hallmarks and imaging evidences. The five patients in the EA group were in the early stage of disease, showing obvious symptoms, and had not yet received standard treatments, including various NSAIDs and DMARDs. The five patients in the LD group were all disabled, and confirmed by radiographic evidence of structural damage in hip joints and spinal deformity. The four patients in the RM group received standardized treatment under the guidance of specialist doctors, and maintained clinical remission and normal laboratory indicators for over six months. Patients in both EA and RM groups were confirmed to have no structural damage or deformities by radiographic evidences.


Eligibility Criteria:
Inclusion Criteria:

Clinical diagnosis of ankylosing spondylitis Clinical hallmarks and imaging evidences

Exclusion Criteria:

Pregnant patients Other diseases, tumors and injuries
Acupuncture for Hemiplegic Shoulder Pain

Shoulder pain has been reported to be one of the most common complications after stroke. Several factors have been related to shoulder pain after stroke such as paralysis, restricted range of motion in the shoulder, spasticity, sensory abnormalities, but the relationship between these factors and pain was not discussed.

The aim of this study is to identify the efficacy of electroacupuncture in reducing upper limbs spasticity and shoulder pain in stroke patients, and to evaluate the quality of life (QOL) for stroke patients.


Eligibility Criteria:
Inclusion Criteria:

* Stroke within 6 months from onset
* Hemiplegia with shoulder pain (VAS \> 2)

Exclusion Criteria:

* previous pathology of the shoulder or cardiac pacemaker, and cognition problems
Contrast-enhanced Ultrasound for Follow-up After Radiofrequency Ablation of Kidney Lesions

Radiofrequency ablation (RFA) is an increasingly popular therapy option for treating small kidney cancer, especially for patients who are not ideal candidates for traditional surgery. Currently, follow-up after this procedure involves the patient having several CT scans (or MRI scans in some cases) over time to monitor for possible cancer recurrence. However, there are risks associated with the radiation exposure from CT scans and other risks, such as adverse events from the contrast media used in these scans. This study will therefore investigate whether a different technique, contrast-enhanced ultrasound (CEUS), can be an effective tool for follow-up monitoring of kidney cancer patients who have undergone RFA by comparing the results of their standard follow-up CT scans (or MRIs if applicable) with the results of CEUS. If CEUS is found to be just as effective as CT scans or MRIs in detecting kidney cancer recurrence, this technique could potentially become the new standard of care for follow-up.


Eligibility Criteria:
Inclusion Criteria:

* at least 18 years of age and capable of giving informed consent
* patient undergoing CT of MRI for monitoring of renal lesions after radiofrequency ablation

Exclusion Criteria:

* pregnant patients
* patients with allergies to iodinated contrast agents
* patients with pulmonary hypertension, right-to-left cardiac shunts, or unstable cardiopulmonary disease (these are absolute or relative contraindications to the use of the ultrasound contrast agent, perflutren lipid microsphere)
Phase III Clinical Trial to Evaluate the Efficacy and Safety of DP-R208 and Each Monotherapy

The purpose of this study is to determine superiority of DP-R208 compare to each monotherapy in patient with hypertension and primary hypercholesterolemia.


Eligibility Criteria:
Inclusion Criteria:

* Both man and woman who is over 19years old.
* Hypertension with primary cholesterolemia and satisfy the lab results that Mean msSBP is under 180mmHg and Mean msDBP is under 110mmHg and LDL-C is 250mg/DL or under and Triglycerides is under 400mg/dL

Exclusion Criteria:

* Therapeutic lifestylechange is not enought during the study period
* SBP difference is bigger than 20mmHg or DBP difference is bigger than 10mmHg at screening visit
Efficacy and Safety of an Electronic Nicotine Delivery Device (E-Cigarette)

The study's major aim is to investigate the ability of a commercial Electronic Nicotine Delivery Device (E-Cigarette) to induce long-term smoking reduction/abstinence in smokers unwilling to quit. Secondary aims are to investigate changes in withdrawal symptoms and cravings and to examine whether concomitant use of the E-Cigarette and smoking is safe.

The study will monitor smoking reduction/abstinence effects, changes in withdrawal symptoms, and adverse events of a currently marketed device in Italy ("Categoria" electronic cigarette - "ORIGINAL" 7.2 mg nicotine cartridges).

The primary hypothesis is that the E-Cigarette is a safe device that allows smoking reduction or abstinence in smokers possibly by suppressing withdrawal symptoms and cravings.

The electronic cigarette (E-Cigarette) is an electronic nicotine delivery systems designed for the purpose of nicotine delivery to the respiratory system where nor tobacco nor combustion are necessary for its operation. For these reasons, it is possible that this product may be safer than cigarettes. Marketing claims also include that they can be useful smoking cessation aids. Although E-Cigarette may produce lung delivery of nicotine similar to that of tobacco cigarettes and reproduces the gesture component associated with tobacco smoking, very little is known about the effect of E-Cigarette on the smoking habits of regular tobacco smokers.

Therefore, we designed a prospective observational study consisting of 8 office-based visits (a baseline visit and a 2, 4, 6, 8, 10, and 12-weeks and a final visit at 24-weeks) to monitor possible modifications in the smoking habits of a group of well characterized regular smokers experimenting the e-cigarette focusing on long-term smoking reduction/abstinence, changes in withdrawal symptoms/cravings and adverse events.

Specifically, 100 smokers will be given "Categoria" electronic cigarette loaded with "ORIGINAL" 7.2 mg nicotine cartridges and followed up for a total of 24 weeks.

Eligibility Criteria:
Inclusion Criteria: healthy smokers unwilling to quit, between 18 and 60 years of age. They should report a cigarette intake of ≥ 15 cig/day for at least 5 years. At screening they must provide a CO level of ≥ 15 ppm and an FTND ≥ 5.

Exclusion Criteria: alcohol and illicit drug use, breastfeeding, or pregnancy. Individuals who report current attempts to quit smoking and previous experience with electronic cigarettes will be also excluded.
Luteolin for the Treatment of People With Schizophrenia

Luteolin is a natural product found in foods such as celery, green pepper, parsley, and chamomile tea. It has been found to have anti-cancer, anti-oxidant, and anti-inflammatory properties. The purpose of this study is to determine if luteolin helps improve symptoms of schizophrenia.

The study is a 12-week, double-blind, placebo-controlled, parallel group, randomized clinical trial of the efficacy of luteolin for the treatment of people with schizophrenia, who present with residual symptoms and cognitive impairments. The study will be conducted at two sites: The Maryland Psychiatric Research Center (MPRC) and the University of California Los Angeles (UCLA). Participants will be randomized to either 300mg BID luteolin (three 100mg capsules) or placebo. We hypothesize that luteolin will have significant beneficial effects on global psychopathology and cognitive impairments; decrease antioxidant stress and levels of inflammatory markers; and that improvement in global psychopathology and cognition will be associated with changes in the oxidative stress and inflammatory measures. We also hypothesize that luteolin will be associated with improvements in positive and negative symptoms of schizophrenia.

Eligibility Criteria:
Inclusion Criteria:

* Either male or female of any race
* Age is 18-60 years old
* Meets DSM-5 criteria for schizophrenia or schizoaffective disorder
* Positive and Negative Syndrome Scale (PANSS) total score of 75 or more OR a Clinical Global Impression severity of illness item score of 4 or more
* Clinically stable
* Treated with the same antipsychotic for at least 60 days and have received a constant therapeutic dose for at least 30 days prior to study entry
* Able to participate in the informed consent process and provide voluntary informed consent

Exclusion Criteria:

* Meets DSM-5 criteria for alcohol or substance misuse (except caffeine and nicotine) within the last 6 months; or a positive baseline urine drug screen. Participants who meet DSM-5 criteria for marijuana misuse - mild will be included in the study
* A current infection, including HIV and Hepatitis C; or an organic brain disorder or medical condition, whose pathology or treatment could alter the presentation or treatment of schizophrenia or significantly increase the risk associated with the proposed treatment protocol
* Currently taking immunosuppressive medications (e.g. oral scheduled corticosteroids, chemotherapy or transplantation or HIV/AIDs associated drugs); or anti-inflammatory medications, including NSAIDs (e.g. ibuprofen, celecoxib, or naproxen) or aspirin \> 81 mg on a daily basis. The use of PRN anti-inflammatory agents will be allowed.
* Female participants who are pregnant or nursing
Extension Study of Secukinumab Prefilled Syringes in Subjects With Moderate to Severe Chronic Plaque-type Psoriasis Completing Preceding Psoriasis Phase III Studies With Secukinumab

This was an extension study of secukinumab prefilled syringes in subjects with moderate to severe chronic plaque-type psoriasis completing preceding psoriasis phase III studies with secukinumab. Subjects on secukinumab at the end of treatment period in phase III studies (e.g., ongoing CAIN457A2302 and CAIN457A2303 and potentially other secukinumab phase III studies) were eligible to join this extension study. This extension study was planned to collect an additional 2 years of long-term efficacy, safety, and tolerability data of secukinumab in either continuous or interrupted therapy (randomized withdrawal period) in subjects showing at least partial response to secukinumab and completing treatment period on secukinumab in previous phase III studies. In this extension study, the prefilled syringe (PFS) liquid formulation of secukinumab were used.


Eligibility Criteria:
Key Inclusion Criteria:

Completed the full study treatment period of 52 weeks in preceding phase III studies, and have been receiving secukinumab treatment during the maintenance phase of the preceding phase III studies, and show at least a partial response (PASI 50 or better) at Week 52 of the preceding phase III studies.

Written informed consent form.

Key Exclusion Criteria:

A protocol deviation in either of the preceding phase III studies which according to the investigator prevented the meaningful analysis of the extension study for the individual subject.

Ongoing use of prohibited psoriasis or non-psoriasis treatments.

Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test (\>10 mIU/mL).

Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unwilling to use effective contraception during the study and for 16 weeks after stopping treatment.
Single Anastomosis Sleeve Ileal Bypass Versus Single Anastomosis Sleeve Jejunal Bypass

to compare the results of SASI to SAS-J in treatment of morbid obesity

200 of patients indicated for obesity surgery will be divided into 2 groups : Group 1, will be operated by SASI and Group 2, will be operated by SAS-J

Eligibility Criteria:
Inclusion Criteria:

* obese patients with BMI more than 40 with or without co-morbidity or more than 35 with co-morbidity
* patients fit for laparoscopic surgery
* give approval to share in the study

Exclusion Criteria:

* patients refused to share in the study
* patients unfit for surgery
* patients aged less than 18 and older than 60
* patient with previous upper abdominal surgery either for obesity or other diseases
* revisional bariatric procedures
Different Insulin Regimens and Postprandial Coagulation Activation

The purpose of this study in patients with type 2 diabetes was to investigate the acute effect of postprandial blood glucose levels modified by two different insulin treatment regimens on coagulation activation, inflammation and endothelial cell function. The investigators hypothesized that the rapid-acting insulin analogue aspart has a beneficial postprandial effect on coagulation, endothelial dysfunction and inflammation compared with the intermediate-acting insulin NPH due to its ability to lower postprandial glycaemia.


Eligibility Criteria:
Inclusion Criteria:

* age 30-75 years
* BMI \> 25 kg/m2
* type 2 diabetes for more than 4 years
* pharmacological anti-diabetic treatment with insulin NPH at bedtime or insulin aspart at meals for more than 24 months
* metformin with stable dose \>1000 mg/d for more than 12 weeks
* acetylsalicylic acid (75 mg/d) for more than 2 weeks
* no other anti-diabetic treatment 3 month previously
* HbA1c\<8.5% at recruitment.

Exclusion Criteria:

* creatinine \> 120 µmol/l
* ALAT /ASAT \> 2.5 x upper reference limit
* use of anticoagulants within 1 month previously
* any changes in dose of statins within 1 month previously
* night work
* present or planned pregnancy
* mental sickness or alcohol abuse
* clinically relevant major organ or systemic illness
* uncontrolled hypertension \>180/110 mmHg
* steroid treatment
* known or suspected allergy to trial medications.
Phase III Clinical Study in Patients With Mild to Severe Scalp Psoriasis

A Randomized, Double-Blind, Vehicle-Controlled, Parallel-Design, Multiple-Site, Phase III Clinical Study to Evaluate the Efficacy and Safety of DSXS topical product in Patients with Mild to Severe Scalp Psoriasis

To evaluate the therapeutic efficacy and safety of DSXS topical product (Taro Pharmaceuticals, U.S.A., Inc.) compared to a Vehicle topical product (Taro Pharmaceuticals, U.S.A., Inc.) in patients with mild to severe scalp psoriasis.

Eligibility Criteria:
Inclusion Criteria:

* Male or non-pregnant, non-lactating females 18 years of age and older.

Exclusion Criteria:

* Females who are pregnant, lactating or likely to become pregnant during the study.