cyrilzakka/clinical-trials huggingface dataset:
Translating Dietary Trials Into the Community

A diet that is rich in fruits, vegetables, and low fat dairy foods is known to lower blood pressure in adults. This research project seeks to promote the adoption of the Dietary Approaches to Stop Hypertension(DASH)eating pattern by African American adults with hypertension or prehypertension living in a lower income minority community. The randomized trial phase of this project will test a group-based intervention using materials adopted from prior studies and tailored to the community of interest.

Hypertension (HTN) is a prevalent risk factor for cardiovascular, cerebrovascular, and renal disease, and disproportionately affects African Americans (AA). Although HTN awareness and treatment rates among AA are similar to, or exceed non-Hispanic whites, control of HTN among AAs remains inadequate. Randomized clinical trials have demonstrated the effectiveness of lifestyle measures in lowering BP, including the Dietary Approaches to Stop Hypertension (DASH) diet, which lowers systolic BP 6-14 mmHg. DASH calls for increased consumption of fruits, vegetables, and low fat dairy, and decreased saturated fat and sodium intake. There is limited evidence that DASH has been widely adopted by the public and AA from lower income communities may be less able to adopt DASH as currently disseminated due to barriers related to income, education, attitudes about foods, health beliefs, and neighborhood availability of healthier foods. We propose to utilize quantitative and qualitative research techniques (including focus groups and surveys) to assess environmental, intra-personal, interpersonal and cultural factors that could affect the translation of the DASH diet in a low-income AA community, then utilize the knowledge gathered to adapt existing intervention strategies and tools. These will provide the materials for a randomized three month pilot lifestyle intervention implementing the DASH diet. The 40 participants will be aged 21+ and have pre-HTN or HTN with blood pressure between 120-150/80-95 mmHg on 0,1 or 2 antihypertensive agents, and will be AA residents of two zip codes in Winston-Salem (a lower-income area whose population is significantly minority).

Eligibility Criteria:
Inclusion Criteria:

* Being African American
* Age 21 years or older
* Residing in zip code 27105 or 27101
* Formal education less than 4-year college degree
* Blood pressure between 120/80 mmHg and 150/95 mmHg, inclusive (patients on BP lowering drugs eligible if BP is in above range)
* Willing to provide informed consent
* Able to participate in English

Exclusion Criteria:

* Clinical history of congestive heart failure
* Clinical history of diabetes, or newly diagnosed diabetes at screening
* Clinical history of renal insufficiency (Stage 3 or higher chronic kidney disease)
* BMI less than or equal to 18.5 kg/m2 or greater than or equal to 45.0 kg/m2
* Pregnancy
* Non-English speaker
A Combination Mindfulness and Music Intervention for Acute Pain

This project is a single-site, four-arm, randomized controlled trial evaluating a combination mindfulness + music intervention on acute pain among patients in an orthopedic clinic waiting room. Participants will be randomized to one of four conditions: 1) a 5-minute mindfulness recording, 2) a 5-minute mindfulness recording with an accompanying sustained tone at 65.41 Hertz, 3) a 5-minute mindfulness recording with an accompanying binaural beat set at 65.41 Hertz in the left ear and 69.41 Hertz in the right ear, or 4) a 5-minute mindfulness recording with an accompanying binaural beat set at 65.41 Hertz in the left ear and 69.41 Hertz in the right ear as well as instrumental, theta wave music.


Eligibility Criteria:
Inclusion Criteria:

* Being 18 years of age or older
* Receiving pain treatment at Tallahassee Orthopedic Center
* Understanding English instructions fluently

Exclusion Criteria:

* Unable to consent because of physical or mental incapacity.
Tribal Health and Resilience in Vulnerable Environments

The THRIVE study is a healthy retail intervention that improves the food environments in tribally owned and operated convenience stores in the Chickasaw Nation and Choctaw Nation of Oklahoma.

The THRIVE study is a cluster randomized trial, using a community-based participatory research approach, of "healthy makeovers" in eight convenience stores owned and operated by the Chickasaw Nation and Choctaw Nation of Oklahoma. The study will test the ability of tribal nations to increase fruit and vegetable purchasing and consumption among tribal members through environmental and policy approaches. Investigators hypothesize that tribal members exposed to the highest doses of the intervention (i.e. those who visit the intervention convenience stores the most) will increase their fruit and vegetable intake. Individual-level changes in fruit and vegetable intake will be measured via a survey administered to a cohort of 1600 American Indian shoppers before and after the intervention. A multimedia manual, Website, and documentary film will be created as part of the implementation of THRIVE to engage tribal citizens, enhance local knowledge, and guide other tribes to improve their food and physical activity environments.

Eligibility Criteria:
Inclusion criteria

* American Indian or Alaska Native
* Residing in the tribal jurisdictional areas
* No plans of moving within 12 months
* Self-report shopping at the stores for food at least 3 times per week

Exclusion Criteria:

• Anyone who does not meet these criteria
A Study of ELI-002 7P in Subjects With KRAS/NRAS Mutated Solid Tumors

This is a Phase 1/2 study to assess the safety and efficacy of ELI-002 7P immunotherapy (a lipid-conjugated immune-stimulatory oligonucleotide \[Amph-CpG-7909\] plus a mixture of lipid-conjugated peptide-based antigens \[Amph-Peptides 7P\]) as adjuvant treatment in subjects with solid tumors with mutated KRAS/NRAS. This study builds on the experience obtained with related product ELI-002 2P, which was studied in protocol ELI-002-001 under IND 26909.

The study consists of 3 phases: Phase 1A, Phase 1B, and Phase 2. In Phase 1A, seven Amph modified KRAS and NRAS peptides, G12D, G12R, G12V, G12A, G12C, G12S, G13D (Amph-Peptides 7P) will be evaluated in combination with recommended Phase 2 dose of Amph-CpG-7909 (10.0mg). This Amph-CpG-7909 dose will be evaluated with two Amph-Peptides 7P dose levels (1.4mg and 4.9mg) in 6 subjects per dose level. Following enrollment of these 12 subjects, the independent data monitoring committee (IDMC) will decide if another 6 subjects should be enrolled or if the dose can be determined for Phase 1B and Phase 2 portions of the study to be opened. If another 6 subjects are enrolled to Phase 1A, the IDMC will meet again to decide upon the dose for Phase 1B and Phase 2 prior to opening these portions of the study.

In Phase 1B, one dose expansion cohort of up to 17 colorectal cancer \[CRC\] subjects may be added to evaluate for preliminary evidence of biomarker response, including circulating tumor deoxyribonucleic acid (ctDNA) and/or serum tumor biomarker (such as CA19-9 and CEA) reduction and clearance in KRAS and NRAS.

In Phase 2, an additional 135 PDAC subjects will be randomized 2:1 (ELI-002 7P versus observation) to further evaluate antitumor activity. Subjects randomized to ELI-002 7P will receive subcutaneous (SC) injections of ELI-002 7P during Immunization and Booster Periods. Subjects randomized to observation will have the same safety and efficacy evaluations and will follow the same assessment schedule as subjects randomized to ELI-002 7P but will not receive study treatment. Subjects randomized to observation will be able to elect to cross-over to ELI-002 7P treatment in the event of confirmed disease progression.

Eligibility Criteria:
Inclusion Criteria:

* KRAS/NRAS mutated (G12D, G12R, G12V, G12A, G12C, G12S, G13D) solid tumor
* Phase 1 only: positive for circulating tumor DNA and/or elevated serum tumor biomarkers (such as CA19-9 and CEA) despite prior standard therapy including surgery and chemotherapy/radiation therapy where applicable
* Screening CT is negative for recurrent disease
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

Exclusion Criteria:

* Presence of tumor mutations where specific therapy is approved
* Known brain metastases
* Use of immunosuppressive drugs
Sensor-based Balance Training in Diabetes: A Virtual Reality Paradigm

Diabetic peripheral neuropathy (DPN) can severely deteriorate balance and gait in patients, thereby increasing risk of fall and injury. The aim of the study is to evaluate the efficacy of a virtual reality game based exercise training for improving postural body sway and gait in diabetes patients with peripheral neuropathy. The exercise training has been specifically designed for DPN patients with lost lower extremity joint perception and uses state-of-the-art inertial sensors (body-worn) to acquire joint movement and provide real-time joint feedback through an interactive interface on a LCD monitor. The investigators hypothesize that tailored exercise with real-time visual joint feedback during exercise will reduce improve balance and gait.

The game includes a series of ankle reaching tasks and crossing of virtual obstacles on the monitor screen; these exercises are aimed to improve weight shifting capabilities and medial-lateral movement of body.

Eligibility Criteria:
Inclusion Criteria:

* Diabetic peripheral neuropathy
* Age \> 50 (Men or Women)
* Able to walk 60 feet

Exclusion Criteria:

* Major lower extremity amputation
* Cognitive deficits (MMSE 24 or below)
* Severely impaired vision
The Effects of A Proprietary Spearmint Extract on Cognitive Performance

This study was designed to evaluate the chronic effects of a proprietary spearmint extract over 90 days of supplementation on aspects of cognitive performance (cognitive function and active reaction time), subjective mood, and sleep quality in healthy men and women.


Eligibility Criteria:
Inclusion Criteria:

* Men and pre-menopausal women, 18-50 years of age.
* Body mass index 18.5-29.99 kg/m2, inclusive or body mass index 30.0-34.99 kg/m2 and body fat via bioimpedance \<39% for women aged 18-39y, \<40% for women aged 40-50y, \<25% for men aged 18-39y, \<28% for men aged 40-50y.
* Participant has at least a high school diploma or the equivalent.
* Participant is recreationally active.
* Participant is judged by the Investigator to be in general good health.
* Participant understands the study procedures and signs forms providing informed consent to participate in the study and authorization for release of relevant protected health information to the study Investigators.

Exclusion Criteria:

* Participant is unable to understand and/or perform required tests.
* Participant is unwilling to maintain normal dietary (including vitamins and supplements), exercise, sleep and medication patterns throughout the study.
* Participant is a habitual consumer of mint tea defined as \>8oz per day.
* Participant is regularly taking a cognitive enhancing supplement.
* Participant has a history or presence of a clinically important cardiac, renal, hepatic, endocrine, pulmonary, biliary, gastrointestinal, pancreatic, or neurologic disorder.
* Participant has a sleep disorder or occupation where sleep during the overnight hours is irregular.
* Participant is pregnant, planning to be pregnant during the study period, lactating, or is of childbearing potential and is unwilling to commit to the use of a medically approved form of contraception throughout the study period.
* Participant is a current user of tobacco (defined as tobacco use within the previous 6 months).
Changes in Microcirculation and Functional Status During Exacerbation of COPD

This study investigates the influence of acute exacerbation of chronic obstructive pulmonary disease (COPD) on retinal microcirculation, on functional status and also investigates the prognostic value of retinal vessel caliber assessment in terms of hospitalization and mortality during 2 years of follow-up.

Recent findings suggest that patients with chronic obstructive pulmonary disease (COPD) are at increased risk for myocardial infarction and stroke during periods of acute exacerbation. These findings might be related to acute endothelial changes associated to increased systemic inflammation. Changes in the microcirculation can be explored noninvasively by studying retinal blood vessels that are visualized in fundus images. The retinal blood vessels have anatomical and physiological features that are comparable with the coronary circulation.

Patients with COPD experience quadriceps muscle weakness, which worsens during hospitalization by \~1% per day. This is the result of physical inactivity, in combination with increased oxidative stress and systemic inflammation. Physical inactivity is induced by the hospital environment, but is also related to symptoms of dyspnea caused by increased work of breathing and oxygen desaturation.

Muscle weakness and physical inactivity are associated to poor functional status and recurrent hospital admissions, independent of pulmonary impairment, which makes those patients with frequent exacerbations prone to enter a vicious cycle.

Simple functional screening tests during hospital stay might enable us to quantify the impact of a hospitalization on functional status and to identify patients at risk for repeated exacerbations.

Eligibility Criteria:
Inclusion Criteria:

* Stable COPD (post-bronchodilator forced expiratory volume / forced vital capacity \< 0.7), no exacerbations in the previous weeks. COPD patients with diagnosis of acute exacerbation, based on the GOLD criteria.

Exclusion Criteria:

* Inability to walk without support from others
PTFE Covered Stents Versus Naked Stents in the TIPS (Transjugular Intra-hepatic Porto-systemic Shunt)

Transjugular intrahepatic portosystemic shunts (TIPS) have been increasingly used for the treatment of complications of portal hypertension in patients with cirrhosis.

The initial experiment of the TIPS was reported during the 1990s with stents of various brands, manufacture and sizes, but all "non covered", thus owing the pseudointimal hyperplasia growing inside the stent, which progressively decreases the diameter of the shunt and thus its efficacy. Since the beginning of the 2000s, appeared stents known as "covered" by polytetrafluoroethylene (PTFE) designed to reduce the obstruction rate and thus the frequency shunt revisions. However, these stents are, on average, 2.5 times more expensive than the non covered stents and the cost-effectiveness ratio of the TIPS according to the type of stents used has not been assessed.

The aim of this multicentric and randomized study is to assess the cost-effectiveness ratio of these 2 principles of TIPS, the one using stents covered by PTFE, relatively expensive but seldom becoming obstructed, and the other using non covered stents, less expensive than PTFE but requiring regular gestures of redilatation.

Population concerned: Patients with a cirrhotic portal hypertension responsible for:

* recurrent variceal bleeding
* refractory ascite (or hydrothorax)


Eligibility Criteria:
Inclusion Criteria:

* Presence of a cirrhosis as documented by previous liverbiopsy or typical clinical signs
* Indication validated of the TIPS (Bavéno IV), except not-controlled acute hemorrhagic :

  * Recurrent variceal bleeding after failure of the usual pharmacological and endoscopic methods
  * Refractory or recurrent ascites or difficult to treat
  * Refractory Hydrothorax

Exclusion Criteria:

* Non cirrhotic HTP
* CHILD C ≥12
* Complete portal vein thrombosis
* Usual contra-indication for TIPS :

  * Known or suspected Hepatocarcinoma by increase of the alpha-foetoprotein \>100 UI/mL associated with the presence of at least one hepatic nodule
  * Cardiac insufficiency defined by a ventricular fraction of ejection \< 40% with the echocardiography preliminary to the procedure
  * Pulmonary arterial hypertension (PAP \> 40 mmHg)
  * Hepatic polycystosis
  * Intra-hepatic bile ducts dilatation,
  * Spontaneous clinical recurrent hepatic encephalopathy
Living After a Rare Cancer of the Ovary: Chronic Fatigue, Quality of Life and Late Effects of Chemotherapy

While they are documented in patients in remission of testicular cancer, the sequelae of chemotherapy and the impact of the disease and its treatments on the living conditions and QoL of women in remission of rare ovarian cancer remain poorly explored.

The coordinator therefore propose a national 2-step case-control study to evaluate 1) chronic fatigue and QoL and 2) chemotherapy-related sequelae in adult patients in remission of surgery-treated TGMO or TSCS (conservative or not) supplemented with chemotherapy


Eligibility Criteria:
Inclusion Criteria:

* Age\> 18 years;
* Patient with an ovarian malignant germ cell tumor (TGMO) or a stroma tumor and / or sex cords (TSCS) treated optimally;
* Patient who has had surgery and chemotherapy (interest group) or only a surgery (control group);
* Patient in remission more than 2 years after the end of the initial treatment;
* Relapse authorized if remission more than 2 years after the end of the treatment;
* Patient with no other cancers (with the exception of basal cell skin carcinomas, in situ cancers of the breast and cervix);
* Patient having signed his consent to participate

Exclusion Criteria:

* Pregnant or breastfeeding woman;
* Psychiatric pathology that may disrupt the course of the study or prevent the interpretation of results;
* Person deprived of liberty;
* Major subject to a legal protection measure or unable to express his consent.
Biodistribution and Dosimetry Evaluation of [124I]FIAU

This protocol will evaluate the biodistribution and dosimetry of \[124I\]FIAU in both healthy volunteers and patients with prosthetic joint infections. This pilot study will also investigate the safety and tolerability of \[124I\]FIAU.


Eligibility Criteria:
The following are the main inclusion criteria for all subjects:

1. Males or females age \> 18 years
2. Informed consent
3. Subjects with chronic medical conditions such as hypertension and diabetes should be considered stable by the principal investigator
4. Women should be postmenopausal or surgically sterile
5. Able to return for all study assessments

In addition, the following main inclusion criteria apply for subjects with suspected prosthetic joint infection:

1. Operative intervention planned in the 30 days following study enrollment
2. Prosthetic joint implant in site for more than 3 months prior to enrollment

The following are the main exclusion criteria for all subjects:

1. Unable to comply with study requirements
2. Indication in the opinion of the principal investigator for surgery within 48 hours of presentation.
3. Receipt of any antibiotic therapy in the 2 weeks preceding imaging
4. Immunosuppression, e.g., human immunodeficiency virus (HIV) infection, s/p organ transplantation, receipt of steroids for \> 10 days at \> 10 mg of prednisone equivalent daily within the 90 days prior to enrollment
5. Requirement for any medication that predisposes to lactic acidosis (e.g., metformin, iron, isoniazid and salicylates; see Appendix A)
6. Requirement for any medication that has potential mitochondrial toxicity, e.g., nucleoside analogues (zidovudine, didanosine, stavudine)
7. History of an inherited mitochondrial disorder (e.g., Leber's hereditary neuropathy, neuropathy, ataxia, retinitis pigmentosa and ptosis \[NARP\], myoneurogenic gastrointestinal encephalopathy \[MNGIE\], myoclonic epilepsy with ragged red fibers \[MERFF\] and mitochondrial myopathy, encephalomyopathy, lactic acidosis and stroke-like syndrome \[MELAS\]
8. Chronic hepatitis B virus (HBV) or hepatitis C virus (HCV) infection
9. Pre-existing myopathy or neuropathy
10. Abnormal liver function tests defined as alanine aminotransferase (ALT) \> the upper limit of normal (ULN), aspartate aminotransferase (AST) \> ULN, gamma glutamyl transferase (GGT) \> ULN
11. Alcohol use \> 3 units per day in men or 2 units per day in women or active intravenous drug use
12. Creatinine clearance \< 30 mL/min
13. Body mass index \> 40
14. Life expectancy \< 6 months
15. Hypersensitivity to iodine
Interest of TEG6S® in Reducing Transfusion Needs During Postpartum Haemorrhage

The main objective of this study is to evaluate fibrinogen consumption, transfusion need, and other security outcomes in women with postpartum hemorrhage of 1000 mL or more, before and after the implementation of a TEG6S® device at a level III maternity unit (Centre Hospitalier Sud Francilien, Corbeil-Essonnes, France).

Acquired obstetrical coagulopathy during massive postpartum hemorrhage (PPH) is a serious and frequent complication of delivery. It has been shown that fibrinogen levels are the first to fall during PPH, and that a level inferior to a threshold of 2g/L is strongly associated with progression to severe PPH, hemostatic impairment, transfusion, and invasive hemostatic procedures.

The clinical diagnosis of coagulopathy is difficult, and the biological diagnosis by usual laboratory tests is often delayed, leading to the empirical administration of fibrinogen and blood products, sometimes unnecessary.

The TEG6S® is a viscoelastic testing device performed on whole blood, which allows a reliable assessment of hemostasis and coagulation quality in about ten minutes.

The anomalies detected by the TEG6S® allow for the early diagnosis of acquired coagulopathy, especially hypofibrinogenemia. Its use during the management of PPH would therefore allow for transfusion savings and potential economic benefits, in addition to improving patient prognosis through early and appropriate treatment (including the absence of early "blind" treatment in the absence of coagulopathy).

Eligibility Criteria:
Inclusion Criteria:

* Woman of 18 years old or more
* Delivery at the level III maternity of Centre Hospitalier Sud Francilien (CHSF) (Corbeil-Essonnes, France) between 2022 and 2024, except deliveries during cyber-attack period at CHSF (from August 2022 to December 2022 included), due to uncertainty over the completeness of the data.
* Presenting postpartum hemorrhage with estimated blood loss of 1000mL or more
* No constitutional hemostasis anomaly
* No treatment interfering with hemostasis
* No use of blood products and/or pro-coagulant products before delivery

Exclusion Criteria:

- Patient informed of the research and refusing the use of the data
Efficacy and Safety of IBI110 in Combination With Sintilimab Versus Sintilimab Alone in Neoadjuvant and Adjuvant Therapy of Radically Resectable Non-small Cell Lung Cancer

The main purpose of this study is to evaluate the neoadjuvant therapy efficacy of IBI110 in combination with sintilimab versus sintilimab alone based on pathologic complete response (pCR) rate in stage IIB (primary tumor \> 4 cm ) to IIIB (N2 only) subjects with radically resectable NSCLC.


Eligibility Criteria:
Inclusion Criteria:

1. Have NSCLC that has been classified as stage IIB (primary tumor \> 4 cm), IIIA, or IIIB (N2 only) per the 8th edition of TNM staging system of International Association for the Study of Lung Cancer (IASLC) and the American Joint Committee on Cancer (AJCC).
2. Subjects with non-squamous NSCLC should undergo genetic testing to confirm the absence of epidermal growth factor receptor (EGFR) sensitizing mutations or anaplastic lymphoma kinase (ALK) rearrangements;
3. Eligible for radical resection (R0 resection) at the thoracic surgeon's discretion, and the lung function meets the criteria for planned surgery;
4. Have at least one measurable lesion per RECIST v1.1 criteria;
5. Have a performance scale of 0 or 1 on the Eastern Cooperative Oncology Group Performance Status (ECOG PS)

Exclusion Criteria:

1. Have pathological evidence for small cell carcinoma, neuroendocrine carcinoma, sarcoma, lymphoepithelial rumen carcinoma, salivary gland tumor, or mesenchymal tumor from the biopsy.
2. Have been previously exposed to immune-mediated therapies, including but not limited to LAG-3 antibody drugs, anti-cytotoxic T lymphocyte antigen-4 (CTLA-4), anti-PD-1, anti-PD-L1, and anti-PD-L2 antibodies.