cyrilzakka/clinical-trials huggingface dataset:
Nonlinear Absorber in Essential Tremor Treatment

The goal of this study is to develop a non linear absorber for patients with essential tremor (ET). It 's an extern passive medical device which should improve patients tremor.

Investigators will evaluate the impact of this medical device through one clinical scale (Fahn-Tolosa-Marin) and accelerometry record. Investigators focus on motor improvement.


Eligibility Criteria:
Inclusion Criteria:

* Adult man or woman between 20 and 90 years old
* Diagnosis of ET (Essential Tremor) established by a neurologist
* ET affecting the upper limbs, associated or not with head tremor
* Drug-resistant nature of ET (failure of beta-blockers, mysoline, benzodiazepine)
* Affiliate to a social security or similar system
* Having given written consent to participate in the study, free and informed.

Exclusion Criteria:

* Severe comorbidity
* ET affecting only the leader
* Wounds on the forearm
* Modification of treatment or surgery to manage ET, planned within 3 months following inclusion
* Cognitive disorder known or suspected by the investigator
* Pregnant or breastfeeding woman
* Persons placed under guardianship, curatorship or under judicial protection
* Persons deprived of liberty, subject to psychiatric care or admitted to a health or social establishment for purposes other than that of clinical investigation

Criteria for premature discharge

* MMSE (Mini-Mental State Examination) score\<24;
* ET of the patient with frequency range not between 4 to 6 Hz or 8 to 12 Hz and/or amplitudes of movement greater than 20°.
* modification of treatment for ET or performance of tremor surgery before the final visit;
* withdrawal of consent or refusal to continue visits.
University At Buffalo Campus Veggie Van Mobile Market

The goal of this observational study is to develop an adaptable mobile produce market model to be used on college campuses to increase college students' access to fresh fruits and vegetables. Food insecurity on college campuses threatens academic success and student well-being, and affects first generation, lower-income, and racial/ethnic minority students at higher rates. This research will include a pilot campus mobile market operated on the University at Buffalo campus. The main questions it aims to answer are: 1.) What makes it hard for students to eat healthy foods on the University at Buffalo campus, 2.) How does a mobile market need to operate on a college campus to best reach students, and 3.) What is the relationship between mobile market use and changes in how many fruits and vegetables students eat, students' ability to consistently eat foods that promote health and well-being, and participation in the Special Nutrition Assistance Program (SNAP).

As first-generation, low-income, and racial/ethnic minority students have improved their access to higher education, food insecurity in United States campuses has increased and threatens their academic success and well-being. College food pantries have been the most common solution but only offer short-term emergency relief, and stigma has prevented their use. To provide a longer-term evidence-based approach that honors students' choices and dignity, this research will inform the development of an adaptable campus mobile market model that consistently provides access to healthy food and promotes nutrition security. The clinical trial portion of the research will evaluate how intervention dosage, gauged by University at Buffalo Campus Veggie Van (UB Veggie Van) visits, total fruit and vegetable purchasing, and incentive redemption, is associated with changes in fruit and vegetable consumption (including skin carotenoids), nutrition security measures, and Special Nutrition Assistance Program (SNAP) enrollment from the beginning to the end of the semester.

Eligibility Criteria:
Inclusion Criteria:

* current students at the University at Buffalo
* completed the online campus survey (Aim 1 of larger funded project)
* experienced food insecurity during Spring 2024
* undergraduate students
* at least 18 years of age
* speak English
* must plan to return to the University at Buffalo campus in Spring 2025.

Exclusion Criteria:

* non-students
* non-English speaking
* students who will not return to campus in Spring 2025
* graduate students
Evaluation of the Severity of Hepatic Fibrosis by Magnetic Resonance Elastography in the Diagnosis of Endogenous Hypercorticism

The main hypothesis of the HEPACORT study is that upon diagnosis of endogenous Cushing's syndrome, significant liver fibrosis may be present, particularly in the most severe forms of Cushing's syndrome.

the HEPACORT study is the first exploratory study to assess the severity of liver fibrosis in patients with Cushing's syndrome or suspected of presenting by Magnetic Resonance Elastography (MRE).


Eligibility Criteria:
Inclusion Criteria:

* age ≥ 18 years old;
* Person affiliated to a social security scheme or beneficiary of such a scheme;
* Person having received complete information on the organization of the research and having signed informed consent;
* Person having carried out a preliminary clinical examination adapted to the research.
* Patients with Cushing's syndrome (for the Cushing's Syndrome group)
* Patients with possible Cushing's syndrome (for the suspected Cushing's Syndrome group) defined as response to the dexamethasone supression test with 1 mg of Dexamethasone, with a plasma cortisol assay at 8 am between 18 and 50 µg/L carried out in the 3 months preceding ;
* Patients with metabolic syndrome (for the metabolic syndrome group)

Exclusion Criteria:

* Person having taken corticosteroid therapy for more than 3 months during the 2 years preceding inclusion;
* Person having received corticosteroid therapy of shorter duration with discontinuation less than one month before inclusion;
* Person having taken anticortisolic treatment for more than 3 months during the 2 years preceding inclusion;
* Person with chronic liver disease;
* Person with alcohol misuse, defined by a weekly consumption of more than 10 standard units;
* Person with a morphotype that does not allow an MRI examination to be performed;
* Woman of childbearing age who does not have an effective means of contraception;
* Contraindication to performing an MRI examination.
* Person referred to in Articles L. 1121-5, L. 1121-7 and L1121-8 of the French Public Health Code.
The Effect of Human Prostate Tissue on Platelet Activation

Transurethral resection of the prostate (TURP) is a common and standard urological surgical procedure for managing benign prostatic hyperplasia (BPH). Although surgical technology improved in recent decades, severe complications such as TURP syndrome, hematuria, and postoperative hemorrhage were still considerable. Coagulopathy is one of rare but devastating complication which may contribute to bleeding during and after TURP. Although the exact pathophysiological condition of coagulopathy is not clear, there are several possible mechanisms of TURP associated coagulopathy including: urokinase- (u-PA) and tissue-type plasminogen activator (t-PA)-related fibrinolysis; absorption of irrigating fluid associated dilutional coagulopathy; release of prostatic particles rich in tissue thromboplastins into the circulation causing secondary ﬁbrinolysis and disseminated intravascular coagulopathy (DIC); sepsis with DIC associated with bacteria entering the circulation due to prostatic venous sinuses opening and the using of high pressure irrigation. On the other hand, platelet are essential to hemostasis and thrombosis and its activation also contributes to leukocyte recruitment and DIC. Furthermore, previous studies demonstrated that activated platelets could express TLR4, CD40L, P-selectin and induce platelet-leukocyte aggregation (PLA), which were considered important for systemic inflammatory responses and DIC development. Currently, no study investigating the association of prostate particle and platelet activation. Here, we tested the hypothesis that prostate tissue may induce inflammatory responses through platelet activation by measuring the expression of TLR4, CD40L, P-selectin and PLA on platelets.


Eligibility Criteria:
Inclusion Criteria:

* scheduled for TURP surgery

Exclusion Criteria:

* morbid obesity, bedridden, thromboembolic disease, sepsis, nephrotic syndrome, trauma, malignant tumor, disease associated with increasing blood viscosity.
Stress, Sleep and Cardiovascular Risk

We are evaluating a model where trauma exposure and threatening environments elicit nocturnal vigilance and sleep-related fears that compromise the healthy reduction of autonomic arousal during sleep which in turn stimulates secretion of atherogenic humoral factors, arterial stiffening, and cardiovascular disease risk. We will examine the roles of pre-sleep cognition using a questionnaire and real time assessment, and modifiable strategies for coping with sleep disruptive cognitions. We will then evaluate the impact of providing personalized feedback and recommendations based on study observations on how participants cope with potentially sleep disruptive cognitions and sleep efficiency in a randomized trial.

The study has 3 specific aims.

Aim 1. To confirm the effects of neighborhood and posttraumatic stress, and nocturnal vigilance on nocturnal autonomic balance determined by complementary biomarkers.

Hypothesis 1a - Neighborhood disorder and posttraumatic stress symptom severity will be inversely correlated with indicators of autonomic balance derived from analyses of heart rate variability and cardiac impedence, and nocturnal/evening urinary noradrenergic excretion ratios.

Hypothesis 1b - These relationships will be partially or fully accounted for by nocturnal vigilance and the frequency and intensity of pre-sleep disruptive cognitions assessed in real time, and strategies for coping with sleep disruptive thoughts.

Aim 2. To determine relationships of nocturnal autonomic activity to biomarkers of inflammation and endothelial dysfunction.

Hypothesis 2 - Indicators of nocturnal autonomic balance will correlate with morning levels of pro-inflammatory cytokines and adhesion molecules; and pulse wave velocity.

Aim 3. To determine if sleep is improved 6 months after receiving personalized recommendations for adaptively modifying sleep-related behaviors, and if improved sleep and reduced pre-sleep cognitive arousal are associated with more favorable nocturnal autonomic balance and endothelial function.

Hypothesis 3a - Reduced frequency and intensity of sleep disruptive cognitions and improved sleep efficiency will be more likely in the group that received personalized feedback and recommendations for sleep.

Hypothesis 3b - Reduction of disruptive pre-sleep cognitions, and increased sleep efficiency will be associated with improved autonomic status at night and a more favorable profile of cardiovascular risk biomarkers.

Eligibility Criteria:
Inclusion Criteria:1. Healthy adults age 18 - 35, self-identified as Black or African American, born in the United States.

Exclusion Criteria:

* current medical or psychiatric condition that affects sleep or requires daily - use of medication other than PTSD, phobic disorders, or past history of major depression
* severe alcohol or drug use disorders
* overnight shift worker or an extreme chronotype
* sleep disorder other than insomnia or nightmares
* morbid obesity (body mass index \> 40)
An Observational Study on The Correlation Between Time of Initiation of Avastin (Bevacizumab) Treatment And Progression-Free Survival in Patients With Metastatic Breast Cancer (CRONOS 2)

This single arm, prospective, observational study will assess the correlation between the time from start of chemotherapy to the start of Avastin (bevacizumab) treatment with progression-free survival in patients with previously untreated metastatic breast cancer. Patients will be followed for up to 12 months after progressive disease occurs.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients, \>/=18 years of age
* Previously untreated metastatic breast cancer
* Scheduled to start 1st line chemotherapeutic treatment
* ECOG performance status 0-1

Exclusion Criteria:

* Any conditions included in contraindication list for Avastin
* Prior chemotherapy for metastatic breast cancer
* Adjuvant/neoadjuvant chemotherapy or radio-chemotherapy of non-metastatic malignancy completed \<6 months prior to treatment start
OA Clinic-Community CARE Model

The purpose of this study is to test the OA Clinic-Community CARE Model (OA CARE) which will address all recommended components of knee/hip (osteoarthritis) OA care, include interventions for both patients and primary care providers (PCPs), and utilize a tailored approach that efficiently matches treatments with patients' needs.

The patient component of OA CARE will include evidence-based weight management and exercise programs for all participants (delivered through the YMCA), as well as tailored referrals to physical therapy, additional weight management or nutrition services, sleep-related services and psychological services.

The PCP component of OA CARE will include a video-based summary of current OA treatment guidelines (with emphasis on practical application), collaboration on patients' referrals to specific services described above, and progress reports on enrolled patients.

This study will be a randomized pilot trial of OA CARE among n=60 patients with knee and/or hip osteoarthritis (OA) and overweight/obesity who are not currently meeting physical activity recommendations. Participants will be randomly assigned to OA CARE or a usual care (UC) group. Assessments will be conducted at baseline, 6 months and 12 months. Primary endpoint of the trial will be self-reported pain and function and secondary endpoint will be objectively assessed physical activity (PA), measured via accelerometer.

Eligibility Criteria:
Inclusion Criteria:

* Clinician diagnosis of knee or hip OA
* Self-reported knee or hip pain of ≥3 (scale of 0-10) on most days of the week
* Current Weekly Physical Activity \<150 minutes per week
* Body mass index (BMI) ≥27 kg/m\^2

Exclusion Criteria:

* No internet access and a device (computer, tablet, smartphone) to access the virtual weight loss intervention
* Pain in chest when performing physical activity
* Pain in chest when not performing physical activity
* No documented diagnosis of knee or hip OA
* Total knee or hip replacement surgery, meniscus tear, ligament tear, or other significant lower extremity injury or surgery in the last 6 months
* Dementia or other memory loss condition
* Active diagnosis of psychosis
* Active Substance abuse disorder
* Severe hearing or visual impairment
* Serious/terminal illness as indicated by referral to hospice or palliative care
* Hospitalization for cardiovascular event in last 6 months
* History of ventricular tachycardia
* Unstable chronic obstructive pulmonary disease (2 hospitalizations within the previous 6 months and/or on oxygen)
* Stroke with moderate to severe aphasia
* Recent history (last 6 months) of three or more falls
* Planning total joint replacement in next 6 months
* Any other health conditions determined by the study team to be contraindications to a home exercise program or weight loss
* Current participation in other study related to knee or hip osteoarthritis or physical activity
* Unable to speak English
Breakfast for Young Females

Investigators will test the health effects of eating a dairy-based protein-rich breakfast or isocaloric breakfast and performing regular physical exercise training for 12 weeks in young overweight women (2 x 2 factorial design). Measurements of body composition, physical fitness, metabolic health parameters, faeces and urine metabolites, and food diary will be collected.

The study is a 2×2-factorial randomized controlled trial with 4 study arms. One-hundred (100) subjects will be randomly allocated to eat breakfast consisting of high-protein yoghurt (300g/day) with oats or an isocaloric breakfast consisting of bread, jam and juice matched for fat and fiber content and to either exercise 3x per week or maintain habitual physical activity for 12 weeks. Measurements and biological sampling will be performed at baseline, half way (some parameters only) and at the end of the intervention period.

The primary outcome will be fat mass and fat free mass determined by DXA. The investigators will also measure effects on weight, waist, health-related blood parameters, muscle function, physical activity, habitual food intake and metabolites in faeces, urine and blood.

Eligibility Criteria:
Inclusion Criteria:

* Body mass index \> 25
* Regular exercise \< 1 hour per week

Exclusion Criteria:

* illness and use of medication affecting the study outcomes
* allergy towards milk and yoghurt
* weightloss/gain \>5kg the last 6 months
* dieting
* eating disorder
* pregnancy
* breast feeding
* unable to speak and understand danish
Evaluation of Vitoss With and Without BMA for Benign Cavitary Lesions

This is a retrospective, two-arm study reviewing the healing of cavitary defects in patients treated with Vitoss alone versus those treated with Vitoss with bone marrow aspirate (BMA). There will be a prospective follow-up visit at 24+ months to evaluate lont-term healing in patients identified during the retrospective portion of the study. It is thought that the inclusion of BMA will facilitate the resorption of the graft material, leading to better long-term bone healing.


Eligibility Criteria:
Inclusion Criteria:

* males and females \>/= 18 years of age at the time of surgery
* Patients treated with Vitoss alone or Vitoss with added BMA between 2004 and 2012
* willing and able to provide Informed Consent to participate in and follow study requirements (including a radiologic assessment)

Exclusion Criteria:

* Patients with a known post-traumatic defect
* active infection at the time of implantation
* history of bone marrow disorders
* contraindications to the use of supplemental BMA
Epidermal Growth Factor Receptor and K-ras Mutations in Patients With Stage III Non-Small Cell Lung Cancer

RATIONALE: Collecting and storing samples of tissue from patients with cancer to study in the laboratory may help doctors learn more about changes that may occur in DNA and identify biomarkers related to cancer.

PURPOSE: This laboratory study is looking at epidermal growth factor receptor mutations and k-ras oncogene mutations in patients with stage III non-small cell lung cancer.

OBJECTIVES:

* Determine the frequency of epidermal growth factor receptor (EGFR) and K-ras mutations in patients with stage III non-small cell lung cancer (NSCLC) treated on CALGB 30106.
* Correlate presence or absence of EGFR and/or K-ras mutations with radiographic response to treatment in these patients.

OUTLINE: Tissue samples are analyzed for epidermal growth factor receptor and K-ras mutations.

Eligibility Criteria:
Inclusion criteria:

1. Eligible patients had histologic documentation of un- treated stage III NSCLC.
2. Radiation oncologist confirmation was required that radiation could be given per protocol.
3. Eastern Cooperative Group Criteria Performance Status of 0 to 2
4. Tumor specimen paraffin block or unstained slides and standard initial laboratory tests
5. Signed institutional review board-approved, protocol-specific in- formed consent in accordance with federal and institutional guidelines

Exclusion criteria:

1. Patients with scalene, supraclavicular, or contralateral hilar lymph node involvement, or direct invasion of the vertebral body or with a pleural effusion were ineligible.
Assessing NHS ImplemeNTation of an onlinE Resilience Training Acceptance and Commitment Therapy (ACT) Programme to Prevent Job Loss in Multiple Sclerosis

People with MS (PwMS) are at increased risk of leaving work earlier than expected. Psychological factors that affect PwMS may make it more difficult to manage staying in work. These can include psychological flexibility and self efficacy. Psychological flexibility is the ability to effectively manage unwanted inner experiences (e.g., thoughts, memories, bodily sensations) in the present. Self-efficacy is the self-belief that an individual has in their ability to succeed.

Acceptance and Commitment Therapy (ACT) may help improve psychological flexibility and self-efficacy. Researchers and PwMS at Leeds have recently co-developed an online ACT-type programme called 'READY for MS'. This online programme may be helpful for PwMS who want to stay in work. READY for MS can be used on a computer or mobile device and does not need time off work traveling to see a psychologist. The aim is to understand the feasibility and effectiveness of training MS healthcare professionals to support delivery of the READY programme. Also to understand the long-term outcomes for both healthcare professionals and the PwMS they are supporting. What contexts contribute to effective delivery of the READY for MS programme will be explored. The aim is to test this READY for MS programme in various NHS settings to ensure that the programme is delivering the outcomes expected. This is a concept referred to as 'Intervention fidelity'. The key outcome that will be measured for PwMS is work instability (i.e. risk of job loss). Participants will be invited to complete online questionnaires. These will be completed at baseline, post-intervention and 6 month follow-up. The study team will invite a sub-set of participants to complete semi-structured interviews. The study team will use regular rapid qualitative analysis methods (lightning reports) to assess implementation.

Eligibility Criteria:
Inclusion Criteria:

* Participants capable of giving informed consent
* Age 18 years or above
* Currently in paid employment with an intention to remain in employment for at least 6 months
* Phase 2: A registered healthcare professional or allied health professional who works in direct contact with patients diagnosed with Multiple Sclerosis OR
* Phase 3: An individual with a clinical diagnosis of Multiple Sclerosis and reporting a WI score ≥11/22 (on MS-WIS)

Exclusion Criteria:

* Individuals lacking capacity to give informed consent
* Individuals intending to leave paid employment within the next 6 months
* Individuals who will not have access to a device used to access the internet (e.g.

laptop or smartphone) for the duration of study participation
The Role of Diet Education and Nutritional Counselling in the Ongoing Care of People Living With HIV in Thailand

To evaluate the effectiveness of nutrition education and dietary counselling to improve the nutritional status, well-being and quality of life of people living with HIV/AIDS (PLWHA) attending an HIV treatment facility in Bangkok Thailand.

To evaluate the effectiveness of nutrition education and dietary counselling to improve the nutritional status, well-being and quality of life of people living with HIV/AIDS (PLWHA) attending an HIV treatment facility in Bangkok Thailand. This will be achieved by determining if dietary counselling and nutrition education has an effect on nutritional status (weight, lean body mass and fat mass), dietary intake, food security, quality of life, biochemical parameters (including total cholesterol, LDL/ HDL cholesterol and Triglyceride), experience of symptoms and patient satisfaction

Eligibility Criteria:
Inclusion Criteria:

* HIV positive
* 18 years of age or older
* Receiving ongoing care as part of the TRCARC Family Clinic (TRCARC Wellness Plus clinic)
* Either ART naive or have been on stable ART for more than 6 months

Exclusion Criteria:

* HIV negative
* Unintentional weight loss of more than 10% usual body weight, or BMI\<17
* BMI\>30
* Suspected or documented HIV related opportunistic infection
* Pregnant women
* Women less than 3 months post-partum