cyrilzakka/clinical-trials huggingface dataset:
A Study of Curcumin (Soloways ™) in Patients With Inflammatory Bowel Disease Homozygous for the IL-10 Variant

This pilot, genotype-stratified clinical trial aims to evaluate the safety and preliminary efficacy of liposomal curcumin in patients with inflammatory bowel disease (IBD) who are homozygous for a specific "unfavorable" IL-10 gene variant (e.g., rs1800896). The study will compare clinical and inflammatory markers in two cohorts: (1) homozygous carriers of the IL-10 variant and (2) non- carriers. The hypothesis is that curcumin supplementation will lead to more pronounced improvement in clinical activity scores and inflammatory biomarkers among homozygous carriers due to their inherently reduced anti-inflammatory capacity.

Inflammatory bowel diseases (including Crohn's disease and ulcerative colitis) are characterized by chronic intestinal inflammation driven by a complex interplay of genetic, immune, and environmental factors. IL-10 plays a crucial role in anti-inflammatory pathways; certain genetic variants can reduce IL-10 production and predispose patients to more severe disease phenotypes.

Curcumin, a polyphenol derived from turmeric, has shown anti-inflammatory effects via multiple molecular targets, including NF-κB. However, curcumin's bioavailability is limited; liposomal formulations may enhance its absorption and therapeutic impact. This pilot trial examines whether liposomal curcumin provides a more significant clinical benefit specifically in patients with the homozygous IL-10 variant, as this subgroup may be particularly responsive to additional anti- inflammatory support.

Eligibility Criteria:
Inclusion Criteria:

- Adults aged 18-70 years with a confirmed diagnosis of ulcerative colitis or Crohn's disease.

Stable background IBD treatment regimen (5-ASA, immunomodulators, or low-dose corticosteroids) for at least 4 weeks prior to enrollment.

* Willingness to undergo genotyping for the IL-10 variant and to comply with the study protocol.
* For the IL-10 Homozygous Variant Cohort: confirmed homozygous "unfavorable" variant (e.g., rs1800896) prior to enrollment. 5. For the Non-Variant Cohort: confirmed absence of the "unfavorable" allele (wild-type).

Exclusion Criteria:

* Use of high-dose corticosteroids or biologics (e.g., TNF inhibitors) initiated within 4 weeks prior to enrollment.
* Known allergy or hypersensitivity to curcumin or related compounds. Severe concomitant illness (significant liver or renal dysfunction, uncontrolled diabetes, etc.) that could interfere with interpretation of results or patient safety.
* Pregnancy or breastfeeding.
* Inability to provide informed consent or comply with study procedures.
Dose Ranging Study of Metronidazole Vaginal Gel in the Treatment of Bacterial Vaginosis

The objective of this study is to evaluate the efficacy and safety of GW05 administered in 3 regimens versus metronidazole 0.75% for the treatment of bacterial vaginosis.

This is a multicenter, randomized, investigator-blinded, phase 2, dose ranging study of GW05 vaginal gel administered in 3 regimens compared to metronidazole 0.75% (QD x 5 days) for the treatment of bacterial vaginosis. Subjects will be evaluated at three timepoints (1 screening/baseline visit, post-treatment phone call and 1 test-of-cure visit). The total study duration may be up to 30 days for a subject.

Study medication will be applied intravaginally once daily at bedtime according to the assigned dosing schedule using the supplied 5-gram vaginal applicators.

Investigator blinding will be ensured by utilizing an independent drug dispensing coordinator at each site.

Bacterial vaginosis (BV) is an infection of the vagina (birth canal) that is the result of an overgrowth of bacteria that are often normally found in the vagina. This type of vaginal infection typically does not cause irritation. The most common complaint of patients who suffer from BV is a fishy-smelling vaginal discharge. The amount of vaginal discharge may or may not be increased above a normal discharge. The bad odor may get worse after sexual intercourse or during the menstrual period. BV is also strongly associated with problems during pregnancy, such as premature (early) birth, and with an increased risk of sexually transmitted diseases. Therefore, it is important to treat the infection.

Eligibility Criteria:
Inclusion Criteria:

* Females at least 18 years of age
* In good general health
* Confirmed current diagnosis of bacterial vaginosis (determined at study screening)
* Negative pregnancy test (for women who are able to become pregnant)
* Must abstain from sexual intercourse throughout the first 7 days of thes study
* Must abstain from alcohol ingestion during the treatment period and for one day afterward
* Must not use intra-vaginal products for the duration of the study

Exclusion Criteria:

* Pregnant, lactating, or planning to become pregnant during the study period
* Menstruating at the time of the diagnosis or anticipate the onset of menses during the treatment phase of the study
* Had a medical event within 90 days of the visit (e.g., stroke, heart attack, etc.)
* Received specific treatments/medications /therapy within the designated time period prior to study enrollment
McKenzie Protocol With/Without Postural Control Exercises on Pain, ROM, and Disability in Low Back Pain

Chronic Low Back Pain (CLBP) is a prevalent global musculoskeletal disorder associated with significant physical, psychosocial, and economic burdens. The McKenzie method focuses on the use of sustained postures or repeated movements tailored to alleviate pain and restore function. Progressive Postural Control Exercise (PPCE) is an innovative approach for managing CLBP. It combines elements of motor control exercises and resistance training, emphasizing challenges to postural control through phased progression to improve stability and function.

The aim of this study is to compare the effects of the McKenzie protocol, both with and without the integration of Progressive Postural Control Exercises (PPCE), on pain, range of motion, and disability in patients with low back pain.

This study utilized a randomized controlled design with two groups. Participants were recruited from Shaikh Zaid Hospital using non-probability convenience sampling. The intervention lasted six weeks, with assessments conducted at baseline, three weeks, and six weeks.

Group A received McKenzie exercises combined with Progressive Postural Control Exercises (PPCE), while Group B was treated with McKenzie exercises alone, without PPCE. Assessment tools included the Numeric Pain Rating Scale (NPRS) for pain, the Roland-Morris Disability Questionnaire (RMDQ) for disability, the Oswestry Disability Index (ODI) for disability, and an inclinometer for measuring range of motion.


Eligibility Criteria:
Inclusion Criteria:

* Patients aged 18-65 years
* Diagnosed with non-specific low back pain, with symptoms and pain persisting for over 3 months
* Individuals reporting a pain intensity of at least 4 out of 7 on the 11-point Numeric Pain Rating Scale (11-NPRS)
* Individuals scoring 4 or above on the Roland-Morris Questionnaire (RMQ) for low back pain

Exclusion Criteria:

* Pregnancy
* Chronic low back pain (LBP) due to trauma, structural issues, neurological symptoms, or radiating pain to the lower legs
* History of back surgery, spinal tumors, or infections
* Diagnosed neurological or musculoskeletal disorders unrelated to LBP, including, Stroke, Parkinson's disease, Demyelination disorders, Multiple sclerosis
Cardiovascular Effects of COVID-19

Cardiometabolic disease may confer increased risk of adverse outcomes in COVID-19 patients by activation of the aldose reductase pathway, a trigger of the inflammatory cascade. The study team hypothesizes that aldose reductase inhibition with AT-001 (caficrestat) might represent a novel therapeutic approach to reduce inflammation and risk of adverse outcomes in diabetic patients with COVID-19.

An open-label pilot study to assess safety, tolerability and efficacy of AT-001 in hospitalized COVID-19 patients with history of diabetes mellitus and heart disease will be conducted. Eligible participants will be treated with AT-001 1500 mg twice daily for up to 14 days. Safety, tolerability, survival and length of hospital stay data were compared with matched controls from a contemporaneous registry of COVID-19 patients.


Eligibility Criteria:
Inclusion Criteria

Registry Study: In order to be eligible to participate in the registry study, an individual must meet all of the following criteria:

1. Age ≥18 years of age
2. Hospitalized at one of the participating NYULH locations
3. Confirmed COVID-19 infection

Interventional Study: In order to be eligible to participate in the registry study, and individual must meet all of the inclusion criteria of the registry study plus the following criteria:

1. Hospitalized at NYU Tisch
2. History of diabetes mellitus or blood glucose measurement \>126 mg/dl AND EITHER
3. History of hypertension and/or ischemic heart disease and/or heart failure OR
4. Other co-morbid condition that in the opinion of the PI increases risk of heart or lung injury related to the aldose reductase pathway

Exclusion Criteria

Registry Study: An individual who meets any of the following criteria will be excluded from participation in the registry study:

1. Persons who have opted out of research participation at NYU
2. Pregnancy

Interventional study: An individual who meets any of the following criteria will be excluded from participation in the interventional study:

1. Persons who have opted out of research participation at NYU
2. Pregnancy
3. Women of childbearing potential
4. Breast-feeding women
5. Participation in another investigational drug protocol within previous 30 days
Effects of Phototherapy on Gait and Balance of Post-stroke Individuals

Hemiparesis and/or hemiplegia is one of the most common clinical signs of stroke, characterized by partial or complete loss of motor function, resulting in varying degrees of impairment and disability. The aim of this study is evaluate the acute effects of application of phototherapy to detect if this therapeutic approach may be beneficial in gait and balance post-stroke individuals. For such, 10 volunteers, with a history of injury (stroke) between 6 months to 5 years, with deficit in functional capacity in the gait due spasticity of extensor muscles of the affected limb, specifically the Triceps Sural. The evaluation will consist of three-dimensional gait analysis, muscle activity during gait, mobility, static and functional balance, and mobility of volunteers.

This is a clinical, randomized, placebo-controlled, crossover and triple-blind study. Ten participants with injury history (stroke) will perform the protocol. The intervention will be held once a week for 4 weeks. Each week a different dose of phototherapy (Placebo, 10J, 30J and 50J) will be applied. The phototherapy, active or placebo, will be applied in 9 different points of anterior muscle of the thigh, 6 different points of posterior muscle of the thigh and 2 different points of the gastrocnemius muscle, bilaterally, before the tests. Only one investigator, that will not participat in any phase of the assessments sessions, will know about what program is active or placebo in phototherapy device. Randomisation will occur by a simple drawing of lots (A, B, C, or D) in the first visit. The phototherapy unit emitted the same sound regardless of the program used, active or placebo. For three-dimensional gait assessment and muscle activity will be used a SMART-D system 140® - BTS Engineering with six cameras, two Kistler force platforms Platform model 9286BA and FREEEMG® electromyography - BTS Engineering wireless system with four channels. In addition, the evaluation will quantify the static balance (force platform), the functional balance (Berg Balance Scale) and mobility (6 minute walk test and go upand team test).

Eligibility Criteria:
Inclusion Criteria:

* Hemiparetic adults with a single stroke event, with crural predominance;
* Injury (stroke) from 6 months to 5 years;
* Aged between 40 and 60 years old;
* In treatment at the Uninove physical therapy clinic;
* Able to walk barefoot, with or without support;
* With verbal comprehension, controlled systemic disease and clinically stable;
* Able to perform the 6-minute walk test.

Exclusion Criteria:

* Subjects with fixed deformities, previous surgery, previous osteoarticular dysfunction, any disease that influences the performance of the march;
* Cognitive impairment detrimental to the tests;
* Subjects who do not fit the inclusion criteria.
Enhanced Recovery Program After Colorectal Surgery in Elderly (ERPOLD)

Comparison of the efficiency of enhanced recovery program after colorectal surgery in elderly patients (≥ 70 yo) and younger patients (\< 70 yo). Efficiency will be rated as a function of length of hospital stay, postoperative complications (medical and surgical, as well as adherence to protocol.

In 1995 Henrik Kehlet described the concept of fast track surgery after colectomy. It consisted of a multimodal and multidisciplinary approach that aimed at controlling the surgical stress response and at mitigating its consequences. Subsequently postoperative recovery is improved and accelerated, which allows a median hospital stay of 2-days after laparoscopic colectomy. The concept of fast track surgery progressively evolved into enhanced recovery programme (ERP). The acceleration of postoperative recovery and the reduction in the duration of hospitalisation are not associated with an increased incidence of surgical complications nor a greater rate of unplanned hospital readmission, but rather result in less medical complications. The economic benefits are obvious.

The elderly present specific physical, metabolic and socio-environmental characteristics that should be considered in case of surgery. Age has been shown to be an independent prognostic factor for postoperative morbidity after colorectal surgery, but this was reported before the development of ERP. Indeed implementation of ERP significantly reduces the rate of postoperative complications, even in the elderly. Increased risk of postoperative morbidity in elderly as compared to younger patients is nevertheless commonly admitted. Moreover adherence of elderly with the items of ERP is usually considered inferior than that of younger patients. Adaptation of ERP to the specificities of elderly is sometimes advocated. All these explain the reluctance of many practitioners to propose ERP in older patients. However recent meta-analyses suggest that implementation of ERP is feasible and efficient in these patients. The retrospective analysis of our first 100 patients introduced in our audit database revealed even similar length of hospital stay for elderly and younger patients.

The investigators therefore compared the length of hospital stay in the elderly and the younger patients and tested the hypothesis of non-inferiority for elderly patients as compared to younger patients. This is a retrospective analysis of 270 consecutive patients scheduled for colorectal surgery, all managed with the same ERP protocol, and prospectively introduced in our audit database.

Eligibility Criteria:
Inclusion Criteria:

• All patients scheduled for colorectal surgery since November 2015

Exclusion Criteria:

• Emergency surgery
Effects of Acupuncture on Sjögren's Syndrome

Sjögren's syndrome (SS) is a multisystemic chronic autoimmune disease characterized by lymphocytic infiltration of the exocrine glands, resulting in salivary and lacrimal glands hypofunction, with symptoms of dry eyes and mouth. Xerostomia and xerophthalmia present profound negative impact on patients' quality of life, especially due to difficulties in swallowing, dysarthria, dysgeusia, halitosis and burning tongue, discomfort and visual disturbances that lead to daily activities difficulty such as driving or reading. Although some drugs may improve symptoms and prevent SS complications, they can cause significant adverse effects and even fail to relieve symptoms. Integrative and complementary techniques have become a therapeutic option for SS patients. Scientific evidence has supported the efficacy of acupuncture in relieving symptoms of xerostomia and xerophthalmia. Due to the lack of well-controlled and standardized clinical studies, this study aimed to conduct a randomized and controlled trial to determine the efficacy of acupuncture as a therapeutic option for SS patients' symptoms relief.

The present study is designed as a 24-month, single centre, double-blind, randomized, controlled, two-arm clinical trial (acupuncture and control). The research will be conducted following the CONSORT recommendations and the STRICTA extension. The study care protocol will consist in acupuncture or control intervention at the selected acupoints (R6, E6,E2, Ig4, VC24, TA23, B2) for 8 weeks, 20 minutes sessions with 12 weeks of follow up. Complementary clinical approaches (sialometry, sialochemistry, Schirmer test, staining with topical lissamine green), and the questionnaires (OHIP-14, Eular Sjögren's Syndrome Patient Reported Index (ESSPRI), Xerostomia Inventory, ocular surface disease index (OSDI) will be performed in weeks 1, 8 and 12. The control group will consist of superficial acupuncture, or placebo, or sham. After all interventions and evaluation methods completed, data will be analyzed for their distribution and homogeneity in order to choose the most appropriate statistical test.

Eligibility Criteria:
Inclusion Criteria:

* Adults ≥ 18 years old, both genres, who consent to participate of the study
* Patients who were diagnosed with SJ according to the criteria of the American College of Rheumatology and the European League against Rheumatism

Exclusion Criteria:

* Patients who have undergone head and neck radiation therapy;
* Patients with a history of neoplasias and salivary gland infections;
* Patients with acquired immunodeficiency virus infection, sarcoidosis, viral hepatitis, diabetes mellitus and smokers;
* Patients with inability to undergo total saliva collection by established techniques;
* Patients who can not attend regular acupuncture sessions;
* Patients who had a change in the dosage of medications in use within 6 weeks before the start of the study.
* Patients who received acupuncture therapy up to 6 weeks prior to the start of the study.
NOX-E36 First-in-Human (FIH) Study

This is the first time NOX-E36 will be administered to man. The principal aim of this study is to obtain safety and tolerability data when NOX-E36 is administered by single intravenous (IV) and subcutaneous (SC) doses to healthy male and female subjects. This information, together with the pharmacokinetic and pharmacodynamic data, will help establish the doses, dosage regimen and route of administration suitable for multiple dose administration to healthy volunteers, followed by the studies in the patient population.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male and female subjects
* Body mass index (BMI) between 19.0 and 29.0 kg/m2 inclusive
* Body weight between 50 and 100 kg inclusive
* Creatinine clearance of greater than 80 mL/min

Exclusion Criteria:

* Male and female subjects who are not or whose partners are not willing to use appropriate contraception methods
* Intake of any prescribed systemic or topical medication within 14 days prior to dosing
* Intake of any non-prescribed systemic or topical medication (including herbal remedies) within 7 days prior to dosing (with the exception of vitamin/mineral supplements)
* Supine blood pressure and supine pulse rate higher than 140/90 mmHg and 100 beats per minute (bpm), respectively, or lower than 90/50 mmHg and 40 bpm, respectively, as confirmed by a repeat assessment
* History of any clinically significant neurological, dermatological, gastrointestinal, renal, hepatic, cardiovascular, psychiatric, respiratory, metabolic, endocrine, haematological or other major disorders
STRONG Program for Cancer Patients

The purpose of the study is to assess the feasibility and participant satisfaction with the Support through Remote Observation and Nutrition Guidance (STRONG) program. The program provides nutrition support for participants living with gastrointestinal cancer who are receiving chemotherapy and surgical treatment.


Eligibility Criteria:
Inclusion Criteria:

* Gastrointestinal Cancer diagnosis (e.g., colon cancer, appendiceal cancer)
* Peritoneal disease diagnosis
* Received Cytoreductive Surgery and Heated Intra-Peritoneal Chemotherapy (CRS-HIPEC) for curative intent at Moffitt
* Transitioned to an oral diet post-surgery
* Able to speak and read English
* Able to provide informed consent

Exclusion Criteria:

* Documented or observable psychiatric or neurological disorder that would interfere with study participation (e.g., psychosis, active substance abuse)
* Undergoing concurrent treatment for a secondary primary cancer
* Receipt of parenteral or enteral nutrition after surgery
Mobile Health Intervention for Family Smoking Cessation in Romania

The objectives of this study are to determine in a randomized controlled trial (RCT) whether a mobile health (mHealth) couples intervention shows promise in increasing smoking cessation among pregnant couples who smoke and to build mHealth research capacity in Romania. The intervention will be novel in its use of the unique functionality of smartphones, its emphasis on the dyadic efficacy for smoking cessation, and the focus on pregnant couples. Our aims are to (1) Test the implementation feasibility, acceptability, and initial efficacy of a culturally-adapted mHealth smoking cessation intervention among couples during pregnancy and postpartum in Romania. (2) Develop mHealth research capacity by enhancing individual and institutional research capabilities in Romania and expanding the existing international research network.


Eligibility Criteria:
Inclusion Criteria:

* pregnant smokers in the 2nd or 3rd pregnancy trimester and their partners.
* 18 years or older
* married or in a stable relationship
* owns and uses an Android smartphone with broadband internet connection
* willing to have the partner contacted for participation.

Exclusion Criteria:

-