cyrilzakka/clinical-trials huggingface dataset:
Comparative Study of Physiological and Cerebrovascular Reactivity in Depression, at the Three Phases of Emotion

The main objective is to compare the physiological reactivity (heart and respiratory rates, galvanic skin response, cerebral perfusion, and startle) in the three phases of emotion between depressive subjects, subjects remitted from depression and control subjects.


Eligibility Criteria:
Inclusion Criteria:

* Female between 18 and 55
* Informed consent form signed
* Affiliated to a medical insurance
* visual and hearing abilities suitable for exams
* for the depressive group (group D): major depressive disorder according to the DSM-IV criteria as evaluated by the MINI test and MADRS score ≥22
* for the depressive patients in remission's group (group R) : matched on age, at least 1 history of major depressive disorder in the last 10 years and solved for more than 6 months, and MADRS score \< 9
* for the control subjects (group T) : matched on age, no psychiatric history, MADRS score \< 9

Exclusion Criteria:

* psychotic disorder, bipolar disorder, addiction, suspected dementia (MMSE\<25)
* current betablockers or neuroleptics treatment
* any current organic unstable pathology
* history of serious cardiovascular disease (coronary syndrome, cardiac arrythmia, etc.)
* smoking \> 10 PY
* history of serious neurologic disease (stroke, cerebral tumour, serious cranial trauma, headache, ...)
* contra-indication to MRI
* uncorrected vision or audition troubles
* patient under juridic protection
* pregnancy, lactating or female without reliable contraception
Leveraging Transdermal Alcohol Monitoring to Reduce Drinking Among DWI Defendants

The current study will evaluate the efficacy of contingency management (i.e., reinforcement for avoiding heavy drinking) among adults arrested for drunk driving and who are at risk for ongoing heavy drinking.

Individuals who have a drunk driving arrest and are at risk for ongoing heavy drinking will be recruited to test the efficacy of contingency management for reducing alcohol use and identifying mechanisms of change. We will recruit those arrested for drunk driving offenses, ≥ 21 years of age, who at risk for ongoing heavy alcohol use and randomize them to one of two groups: control or a contingency management. Participants experience 8 weekly assessments of current alcohol use and other variables associated with changes in alcohol use. Post-intervention, participants will return to the laboratory once per month at 3, 6, 9, and 12 months post-study entry for follow-up procedures to determine the mechanisms of drinking behavior change.

Eligibility Criteria:
Inclusion Criteria:

* arrested for drunk driving offense

Exclusion Criteria:

* significant alcohol withdrawal symptoms
* medical condition that would contraindicate participation (e.g., pregnancy, scheduled surgery)
* inability to comprehend the informed consent process or study instructions
* presence of a DSM-5 psychiatric disorder with symptoms of psychosis and/or delirium
* incarceration
Enhance Physical Activity and Intergenerational Relationship Via Connect Active Program (CAP): a Pilot Randomized Controlled Trial

This study investigates how walking exercises and technology could enhance the quality of life in the older generation. It has three objectives: 1) To examine the effectiveness of the Connect Active Program (CAP) in improving intergenerational relationships, psychological well-being, and physical fitness for older adults; 2) To teach older adults to use mobile apps; 3) To examine the experiences and feedback from participants in using the apps and joining the CAP. This research will provide long-term insights into improving the overall health outcomes of older adults via intergenerational support and increasing the acceptance of mobile technology among older adults.


Eligibility Criteria:
Inclusion Criteria:

* Younger Adults/Participants:

  * Aged 18 to 30
  * Related to the older adult participant (i.e. family member, relatives)
  * Able to understand Cantonese
  * Own a smartphone and have access to the Internet
  * Able to take part in walking exercise and stretching program
* Older Adults/Participants:

  * Aged 60 or above
  * Able to understand Cantonese
  * Own a smartphone and have access to the Internet
  * Capable to participate in walking exercise and stretching program

Exclusion Criteria:

* Older Adults/Participants and Younger Adults/Participants:

  * Diagnosed with a mental disorder by neurologists or psychiatrists
  * With a history of drug addiction
Non-interventional Study of Long-term Treatment of Psoriasis With Calcipotriol Plus Betamethasone in Gel Formulation

The purpose of this observational study is to document the course of disease and relapse management during treatment with Daivobet® Gel under consideration of patient's individual application habits under daily use conditions.


Eligibility Criteria:
Inclusion Criteria:

* Patients with light to moderate psoriasis vulgaris of trunk and extremities and treatment with Daivobet® Gel was planned anyway.
* Minimum of 3 years diagnosed psoriasis vulgaris.

Exclusion Criteria:

* Previous therapy with Daivobet® Gel
* Systemic therapy of psoriasis vulgaris
* Contraindications of Daivobet® Gel in the German package insert
* people that are incapable to give free consent
Outcomes After Intravenous Alteplase / Tenecteplase With or Without Shuxuetong Injection in Routine Clinical Practice

Acute ischemic stroke is one of the main diseases leading to high risk of disability and morbidity worldwide. Since intravenous thrombolysis(IVT) can effectively improve the long-term functional prognosis of acute ischemic stroke(AIS), IVT within 4.5 hours of onset has been widely recommended by international guidelines.

Although 35-53% of AIS patients achieve functional independence after receiving IVT, there are still a large number of patients who are disabled or even dead, and nearly 70% of patients have ineffective recanalization. Therefore, there is an urgent need for therapeutic drugs after IVT to further improve the prognosis and reduce the burden of AIS.

Shuxuetong injection is widely used in China in patients with AIS after IVT, but the situation in real clinical practice is unclear. Therefore, the study aims to evaluate the effectiveness and safety of Shuxuetong Injection in patients with AIS treated with intravenous alteplase and tenecteplase, and obtain high-quality clinical evidence.


Eligibility Criteria:
Inclusion Criteria:

* Hospitalized patients aged ≥18 years
* Diagnosis of acute ischemic stroke
* Receiving alteplase or tenecteplase treatment ≤ 4.5 hours of onset
* Signed informed consent by patient or legally authorized representatives

Exclusion Criteria:

* Having received or planing to undergo endovascular therapy (including mechanical thrombectomy, arterial thrombolysis, angioplasty, etc.)
* Life expectancy is less than 90 days
* Other factors that the researchers think are not suitable for participating in the research
* Currently receiving any experimental treatment
Effects of a School-based Exercise Program on Posture, Trunk Range of Motion, and Musculoskeletal Pain

The objective of this study was to evaluate the effects of a school-based exercise program on posture, trunk range of motion and musculoskeletal pain in schoolchildren. This study was a Randomized controlled trial. The hypothesis was that the exercise group would have the postural deviations corrected, would have the trunk range of motion increased and would have the prevalence of pain decreased, while the control group would have not. Three schools from Brazil participated. The students that have been included (n=300) were randomly allocated to experimental (EG) or control group (CG). The intervention for EG consisted in a program based on stretching and strengthening exercises, applied twice a week, for eight weeks, with group sessions of 50 minutes. CG did not perform any intervention. Qualitative and quantitative postural evaluation (PAS/SAPO), musculoskeletal pain (self-report) and trunk mobility were collected.


Eligibility Criteria:
Inclusion Criteria: to attend elementary school and deliver the consent term signed by the parents.

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Exclusion Criteria: presence of disability on musculoskeletal or neurological system, exercise intolerance or attendance less than 50% in the exercise sections

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Optical Coherence Tomography Angiography in Subjects With Retinal Vascular Disease

This study will perform a prospective, longitudinal analysis of clinical and imaging findings from normal controls and subjects with retinal vascular disease to better define the diagnostic imaging criteria that signify change in disease stage. This includes disease progression in early stages of disease or disease regression with appropriate standard-of-care treatment.

The objective of this study is to perform a prospective, longitudinal analysis of clinical and imaging findings from normal controls and subjects with retinal vascular disease to better define the diagnostic imaging criteria that signify change in disease stage. This includes disease progression in early stages of disease or disease regression with appropriate standard-of-care treatment.

Subjects will be identified from healthy subjects (seen for screening eye exams) and diseased subjects undergoing standard-of-care treatment or screening at eye clinic locations. The study population will include subjects with retinal vascular disease including but not limited to diabetic retinopathy, hypertension, retinal vein/arterial occlusion, and macular degeneration. Subjects who are enrolled will undergo non-invasive, minimal risk, FDA approved diagnostic imaging procedures to identify vascular changes.

The study methods will include retrospective review and collection of clinically approved imaging data that is obtained through standard-of-care methods for subjects who meet inclusion and exclusion criteria. Subjects who are identified in this manner will be asked to participate in a prospective study by each clinical study site.

The study end-points include the correlation of diagnostic imaging findings from Optical Coherence Tomography (OCT) based images with fundus photographs, clinical disease stage and visual acuity.

Eligibility Criteria:
Exclusion Criteria:

* Both subjects with diseases and controls:
* Children (age\<18)
* Pregnant females
* Developmentally delayed subjects
* Subjects unable to provide informed consent
* Inability to cooperate with tests and study instructions
* Images with motion artifact or signal strength \< 7
* History of glaucoma
* History of age-related macular degeneration
* History of any visually significant eye disease
* History of proliferative diabetic retinopathy
* History of any inflammatory disease
* History of heart disease
* History of thyroid disease.
* Additional criteria for controls:
* History of any type of Diabetes Mellitus
* History of any type of Hypertension
Positron Emission Tomography Before Surgery in Evaluating Women With Primary or Recurrent Breast Cancer

RATIONALE: Imaging procedures such as positron emission tomography (PET) may improve the ability to detect the extent of breast cancer.

PURPOSE: Diagnostic trial to study the effectiveness of PET to detect the extent of breast cancer in women who have primary or recurrent breast cancer.

OBJECTIVES:

* Determine the sensitivity, specificity, and accuracy of fludeoxyglucose F 18 (FDG) positron emission tomography (PET) as compared to conventional imaging in determining the extent of disease in women with primary or recurrent breast cancer.
* Determine how often clinical management and operative intervention plans for patients are altered based on these FDG-PET scan findings.
* Determine whether FDG-PET results in more accurate detection of disease in these patients.

OUTLINE: Patients receive fludeoxyglucose F 18 IV. Approximately 1 hour later, patients undergo positron emission tomography imaging. Some patients may undergo a repeat scan in 4-6 months.

PROJECTED ACCRUAL: (50 with primary disease and 50 with recurrent disease) will be accrued for this study within 1-2 years.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Diagnosis of breast cancer for which surgical intervention is planned

  * Large primary breast cancer (i.e., larger than 5 cm, T3) as determined by prior biopsy, physical exam, or mammogram OR
  * Locally advanced breast cancer (T4) OR
  * Clinical suspicion of axillary nodal disease (N1-2) (i.e., stage IIB-IIIA) OR
  * Locally or regionally recurrent disease
* No locally recurrent disease that is non-invasive (i.e., ductal carcinoma in situ)
* No locally advanced disease (e.g., inflammatory breast cancer) that will be treated with neoadjuvant chemotherapy without surgery
* Hormone receptor status:

  * Not specified

PATIENT CHARACTERISTICS:

Age:

* Not specified

Sex:

* Female

Menopausal status:

* Not specified

Performance status:

* Not specified

Life expectancy:

* Not specified

Hematopoietic:

* Not specified

Hepatic:

* Not specified

Renal:

* Not specified

Other:

* No other malignancy except previously treated nonmelanoma skin cancer or carcinoma in situ of the cervix
* No known active infection
* No autoimmune disease or inflammatory disease (e.g., sarcoidosis or rheumatoid arthritis)
* Able to fast for 6 hours and tolerate a FDG-PET scan for the duration of the test
* Not pregnant or nursing

PRIOR CONCURRENT THERAPY:

Biologic therapy:

* Not specified

Chemotherapy:

* See Disease Characteristics

Endocrine therapy:

* Not specified

Radiotherapy:

* Not specified

Surgery:

* See Disease Characteristics
Study of Inborn Errors of Cholesterol Synthesis and Related Disorders

This study will investigate the cause and medical problems associated with a group of genetic disorders known as inborn errors of cholesterol synthesis, in which the body does not produce cholesterol. People with this disorder may have birth defects and learning and behavioral problems.

People with an inborn error of cholesterol synthesis and related disorders, including Smith-Lemli-Opitz syndrome, lathosterolosis, desmosterolosis, X-linked dominant chondrodysplasia, CHILD syndrome, Greenberg dysplasia, and some cases of Antley-Bixler syndrome, may be eligible for this study. People who are carriers of the disorders also may enroll.

Participants and family members will provide blood and urine samples, as well as other tissue samples collected during medically indicated procedures such as biopsy or surgery. These tissues may include, for example, gallstones, cataracts, cerebrospinal fluid, amniotic fluid, lymph tissue, and DNA samples. In rare instances, a skin biopsy may be requested to aid in establishing a diagnosis.

Medical information will also be gathered from medical records, photographs, and X-rays.

...

It is known that inborn errors of cholesterol synthesis give rise to human malformation/cognitive impairment syndromes. Smith-Lemli-Opitz syndrome is the prototypical example of a post-squalene inborn error of metabolism; however, this group of disorders now includes lathosterolosis, desmosterolosis, X-linked dominant chondrodysplasia (CDPX2), CHILD syndrome, HEM dysplasia, and some cases of Antley-Bixler syndrome (1-3). Due to the extremely rare occurrence of some of these disorders, the full phenotypic spectrum has yet to be defined. Cholesterol transport in cells can also cause a disorder known as Niemann-Pick Disease type C (NPC). NPC belongs to a group of disorders known as lysosomal storage disorders. The purpose of this protocol is to 1) allow for the collection of biomaterial and medical information that can be studied to gain insight into the pathological processes; 2) allow for the collection of DNA and medical information from individuals who have a phenotypic resemblance to known disorders of cholesterol synthesis, lysosomal storage disorders or individuals who may be carriers of these disorders.

Eligibility Criteria:
* INCLUSION CRITERIA:

Subjects will be eligible for this study if they have or are suspected to have an inborn error of cholesterol synthesis or if they are related to a proband with a suspected inborn error of cholesterol synthesis. No exclusions will be made based on gender, ethnicity or age.
Correlation of Ultrasound Based Measurements of Liver Stiffness and Steatosis With MRI

The investigators will assess the ability of ultrasound (US) to measure liver stiffness (cirrhosis) and liver fat content (steatosis).

Non-invasive monitoring of liver fibrosis using magnetic resonance imaging (MRI) can help determine which patients will most benefit from interventional therapies to help reverse the condition. Similarly, quantitative assessment of liver fat content using MRI can assist physicians in identifying patients at risk for hepatic steatohepatitis.

Due to the widespread dissemination of US machines and their relative lower cost compared to other imaging modalities, e.g. MRI, the ability of US to assess these parameters widens diagnostic availability.

Patients who have undergone an MRI exam to assess liver stiffness (cirrhosis) and/or liver fat content (steatosis) will be asked to undergo an US exam to assess the same parameters. The cirrhosis and steatosis measurements obtained from both exams will be compared. If US-based measurements of liver stiffness and/or liver fat content are shown to be reproducible and accurate when compared to MRI values (will be used as the gold standard), US may become the first-line diagnostic test for these liver conditions.

Eligibility Criteria:
Inclusion Criteria:

1. participants who have a clinical indication for a standard of care MRI exam that included assessment of the liver
2. participant is at least 18 years of age

Exclusion Criteria:

1. Participants unable to take part in the decision making process on whether to consent to the trial
2. Patients with previous chemoembolization or other focal liver therapies to the liver (\* NOTE: for liver transplant patients, this criterion is only applicable to the transplanted liver)
Tumoral Circulating Cells and Colorectal Cancer Progression

Prospective research of circulating tumor cells as markers of progression risk in colorectal cancer.

This study aims at allowing a better understanding of which circulating tumor cells (CTC) have the higher risk of metastasis of in the overall population of CTC.

Prospective monocenter open-label study.

In the frame of the management of the disease, blood samples will be collected at different times of treatment, regarding disease status (localized of stage II/III, metastatic non resectable, metastatic potentially resectable). Tissue samples will be collected for patients scheduled for surgery.

Eligibility Criteria:
Inclusion Criteria:

1. Patient of more than 18 years old
2. Histological diagnosis of colic adenocarcinoma metastatic or not
3. Before any treatment with systemic chemotherapy
4. Patient affiliated to, or beneficiating of the national security
5. Patient having signed informed consent

Exclusion Criteria:

1. Patient with previous chemothrapy treatment
2. Patient with more than one evolutive tumoral pathology
3. Patient under long-term immunosuppressor treatment
4. Patient with severe infection
5. Pregnant or breasting woman
6. Person in an emergency situation, adult subject to a legal protection measure (a guardian, guardianship or safeguard of justice), or unable of expressing his / her consent.
Mechanism and Immune Function Analysis of SARS-CoV-2 Infection in Hematologic Tumors

The goal of this observational study is to compare the immune function and infection mechanism of patients with hematologic tumors and those people without underlying diseases after infection with SARS-CoV-2. Clinical characteristics, treatment options and responses will be collected. Peripheral blood will be collected from patients with hematologic tumors infected with SARS-CoV-2 and those people without underlying diseases infected with SARS-CoV-2.

To establish a retrospective and prospective cohort of patients with hematologic tumors infected with SARS-CoV-2 and people without underlying diseases infected with SARS-CoV-2. Firstly, peripheral blood samples will be collected at infection time points and after SARS-CoV-2 nucleic acid testing turns negative. Subsequently, the transcriptome sequencing and immunological experiments will be performed to analyze the differentially expressed genes, immune function of cells, etc.

Comparative analysis:

1. To compare the immune function of patients with hematologic tumors and those without underlying diseases after infection with SARS-CoV-2.
2. The transcriptomic and proteomic changes of patients with hematologic tumors are compared with those without underlying diseases after infection with SARS-CoV-2.
3. From the perspective of complex (human protein interaction subnetwork), the dynamic change process of SARS-CoV-2-targeted human protein complex (periodic complex) was deeply explored, in order to further analyze its potential dynamic infection mechanism and provide new clues for the discovery of drug targets.

Eligibility Criteria:
Inclusion Criteria:

- Clinical diagnosis of hematologic tumors Clinical diagnosis of SARS-CoV-2 infection

Exclusion Criteria:

- Severe diseases associated with other systems
Effects of β-glucans on Gut Permeability and Microbiota in Elderly

The investigators aim was to compare healthy young adults, senior orienteers (model of healthy ageing) and elderly with gastrointestinal symptoms on intestinal permeability, microbiota compositions and well-being. In addition, assess whether 3 weeks of oral intake of soluble or dispersible forms yeast-dervied beta-glucan could improve intestinal barrier function against drug-induced barrier disruption vs placebo for a cohort of elderly people with gastrointestinal symptoms, in a randomized double blinded placebo-controlled cross-over clinical trial.

Baseline samples for measurements of intestinal permeability (multisugar test), microbiota composition (faecal samples) and well-being (questionnaires) were collected during the first week for:

Young healthy adults (healthy young controls) Senior orienteers (healthy elderly controls) Elderly with gastrointestinal (GI) symptoms

Thereafter only the elderly with GI symptoms continued into the randomized cross-over trial where they were blindly and randomly distributed one of the following: Soluble yeast-derived beta-glucan, dispersible (whole) yeast-derived beta-glucan and placebo. Each supplement was taken for 3 weeks with a 1 week washout until all participants had taken all supplements. Towards the end of each supplement period, samples for measurement of intestinal permeability and microbiota were collected, in addition to questionnaires being filled out.

Eligibility Criteria:
Elderly with gastrointestinal symptoms

Inclusion Criteria:

* Informed consent signed by study participant
* Age \>55 years
* Scoring above 2 on the dimensions for diarrhoea and constipation on the Gastrointestinal symptoms rating scale (GSRS)
* Mentally and physically fit to complete questionnaires during the study period

Exclusion Criteria:

* Known or genic gastrointestinal diseasewith strictures, malignance's and ischemia.
* Inflammatory bowel diseases (IBD)
* Participation in other clinical trials in the past three months.
* Intake of medications know to change the inflammatory status (i.e proton pump inhibitors, antibiotic, anti-inflammtory medication (including NSAIDs)

Healthy controls

Inclusion Criteria:

* Age ≥ 18 years
* Informed consent signed by the study participant
* Mentally and physically fit to complete questionnaires during the study period

Exclusion Criteria:

* Previous abdominal surgery
* A hypertonic condition demanding medical treatment
* Diagnosed psychiatric disease
* Lactose intolerance
* Usage of medical prescribed medications, expect oral contraceptives, during the 14 days preceding study start
* Premenstrual syndrome
* Pregnant or breast feeding
* Known or genic gastrointestinal disease, with strictures, malignance's and ischemia.
* Inflammatory bowel diseases (IBD)
* Participation in other clinical trials in the past three months.