cyrilzakka/clinical-trials huggingface dataset:
Augmentation of Standard Psychotherapy With a Habit Change App

The goal of this clinical trial is to document the efficacy of using a habit change application (app) as an adjunct to standard psychotherapy among individuals with diabetes receiving mental health treatment for depression, anxiety, or substance use disorders. The main questions it aims to answer are:

Question 1: When behavioral health treatment is augmented with a habit change app for between visit care, does the use of this tool improve mental and behavioral health outcomes?

Question 2: Are there certain populations who benefit more from using a habit change app?

Question 3: Does use of a habit change app impact healthcare utilization and costs?

Exploratory Research Question: Does use of a habit change app impact physical health outcomes, including A1c levels, blood pressure, and weight?

Participants selected to receive the habit change app will be asked to track goals that they set for themselves in adjunct to their current behavioral health treatment; those selected for treatment as usual will have no additional steps to take. Researchers will compare the groups to see if there are different outcomes in symptom reports and healthcare utilization.

As part of this research, participants with a diagnosis of diabetes and depression, anxiety, and/or substance use disorder will be randomized to one of two treatment groups: (1) Habit Change and (2) Treatment as Usual (TAU). All participants will currently be engaged in behavioral health treatment. Participants in the Habit Change arm will obtain access to a habit change app and set their personal health goals in the app to track throughout the study period. Participants in the TAU arm will continue to engage in their behavioral health treatment as usual and will not be provided access to the habit change app. Participants randomly assigned to the Habit Change arm will be asked to track behaviors related to their specific goals on a daily basis through the app and will be allowed to engage with the app freely. Outside of using the app, participants will not be asked to engage in any additional activities beyond those typically engaged in for behavioral health treatment (e.g., completion of mental and behavioral health outcome measures).We will be recruiting up to 600 participants as part of this research study (300 per treatment arm).

Eligibility Criteria:
Inclusion Criteria:

* Type 1 or 2 Diabetes
* Are being seen by a clinician for depression, anxiety and/or substance use disorder
* Speak English
* Have an Apple device to download the habit change app

Exclusion Criteria:

* Unable to provide informed consent
Hemosonics- VCU Cardiac Surgery Clinical Study

This study compares the results of current standard coagulation measurement devices to the Quantra System, a new device, using small amount of extra blood obtained during routine blood draws in cardiac surgery patients.

HemoSonics is developing a novel POC diagnostic device, the Quantra System, to perform whole blood coagulation analysis and which is suitable for use in surgical and intensive care settings. The Quantra System employs a patented technology named sonorheometry, which was invented at the University of Virginia. Sonorheometry uses ultrasound pulses to characterize the dynamic changes in viscoelastic properties of a blood sample during coagulation and clot lysis. The initial assay performed on the Quantra System will be the surgical assay for monitoring hemostasis during major surgical procedures in adult patients.

A clinical study will be conducted to evaluate the analytical performance as well as provide a preliminary evaluation of the performance comparability of the HemoSonics' device as compared to existing coagulation monitoring technology in heart surgery. This study will be performed at HemoSonics and the Virginia Commonwealth University Medical Center and will involve patients undergoing cardiac surgery requiring bypass.

Eligibility Criteria:
Inclusion Criteria:

* Subject is scheduled for cardiac surgery involving bypass circuit
* Subject is older than 18 years
* Subject is willing to participate and he/she has signed a consent form

Exclusion Criteria:

* Subject is unable to provide written informed consent
* Subject is incarcerated at the time of the study
* Subject is affected by any condition that, in the opinion of the surgical team, may pose additional risks
* Patients on emergency cases
A Study of RAY1225 in Participants With Impaired Kidney Function

The purpose of this study is to assess how fast RAY1225 gets into the blood stream and how long it takes the body to remove it in participants with impaired kidney function compared to healthy participants.


Eligibility Criteria:
Inclusion Criteria:

1. Body mass index (BMI) ≥18 to ≤28kg/m2 and total body weight \>50 kg(male) or \>40kg(female) at Screening (calculated as a function of measured height and weight according to the formula, BMI = kg / m2 where m2 is height in meters squared);
2. Ability to understand and willingness to sign a written informed consent form;

   Participants with normal renal function only:
3. Normal physical examination, vital signs, 12-lead ECG, Chest X-ray images (anteroposterior) and clinical laboratory values, or any abnormality that is non-clinically significant；
4. Glomerular filtration rate (GFR)≥ 90 mL/min and \<130 mL/min ；
5. Age, BMI, and sex comparable to those of subjects of renal impairment；

   Participants with severe renal impairment only:
6. Diagnosis of CKD (any indicators of renal impairment or GFR \< 60 mL/min/1.73 m2 for more than 3 months)；

Exclusion Criteria:

1. Participants with an allergic disposition (multiple drug and food allergies) or who, have known allergies to RAY1225 or related compounds;
2. Have a personal or family history of medullary thyroid carcinoma or have multiple endocrine neoplasia syndrome type 2;
3. Participants who donated blood or bleeding profusely (\> 400 mL) in the 3 months or donated blood or bleeding profusely (\> 200 mL) in the 1 months;
4. Pregnant or lactating women, or women of childbearing age with a positive pregnancy test
5. Participants with serious infections, trauma, gastrointestinal surgery or other major surgical procedures within 4 weeks

   Participants with severe renal impairment only:
6. Participants with acute renal failure, or a kidney transplant history; or requiring renal dialysis during the study period;
7. Hypertension that is not well controlled with antihypertensive medication (systolic blood pressure ≥ 160mm Hg or diastolic blood pressure ≥ 100mm Hg)
8. New York heart association (NYHA) class III or IV congestive heart failure
9. Alanine aminotransferase (ALT) ≥ 2×ULN, aspartate aminotransferase(AST) ≥ 2×ULN; Serum total bilirubin \> 1.5×ULN;
CASPR2 Encephalitis Initial Symptoms

Auto-immune encephalitides involve auto-antibodies targeting the central nervous system, and particularly the synapse and its structure, such as protein CASPR2.

CASPR2 antibody-associated auto-immune encephalitides lead to an inflammation of the limbic system and generate focal temporal seizures and cognitive impairment. Most patients are initially hospitalized because of the temporal seizures (Joubert et al., JAMA Neurology 2016). However, many already show at that time cognitive impairment, which has failed to elicit the appropriate investigations, therefore delaying the diagnosis.

The study will hence investigate precisely the initial, sometimes neglected, clinical symptoms and those leading to the diagnosis, in the cohort of patients suffering from a CASPR2 antibody-associated encephalitis, from the French reference center on paraneoplastic neurological diseases and autoimmune encephalitis.

This way, the study aims to delineate the symptoms that should trigger suspicions of a CASPR2 antibody-associated encephalitis


Eligibility Criteria:
Inclusion Criteria:

* Positive CASPR2-Ab in serum and/or CSF tested by immunohistochemistry on mouse brain slices and confirmed by cell-based assay (CBA) of HEK293 cells expressing CASPR2.
* Diagnosis and follow-up in France
* From 18 to unlimited age

Exclusion Criteria:

* Patients CASPR2-IgG negative in serum and CSF
* Foreign follow-up
Relationship Between Dopaminergic Asymmetric Degeneration and Attentional Resources in Parkinson's Disease.

The researchers aimed to investigate the relationship between the asymmetric dopaminergic degeneration and the attentional resources in a group of patients with Parkinson's disease (PD).

To bypass the impaired habitual motor-behavioural control, Parkinson's disease (PD) patients may exploit the network of goal-directed mode of action. The frontostriatal connections underline this functioning, that is based on attention. Since the cognitive processes are related with dopamine, the asymmetrical degeneration of the dopaminergic system affects differently the right side affected (RPD) and the left side affected (LPD) PD patients.

The aim of the study was to investigate the relationship between the asymmetric dopaminergic degeneration and the attentional resources in a group of patients with PD.

Eligibility Criteria:
Inclusion Criteria:

* Stage 2.5-3 according to the Hoehn and Yahr scale (H\&Y);
* Stable pharmacological treatment for the last 6 weeks before the enrolment and during the hospitalization;
* Mini Mental State Examination (MMSE) ≥ 24;
* No evidences of dysexecutive syndrome.

Exclusion Criteria:

* Any focal brain lesion detected in brain imaging studies (CT or MRI) performed in the previous 12 months;
* Drug-induced dyskinesias;
* Disturbing resting and/or action tremor, corresponding to scores 2-4 in the specific items of UPDRS III;
* Behavioral disturbances (evaluated with Neuropsychiatric Inventory);
* Visual and auditory dysfunctions according to the general clinical evaluation and medical history;
* Equivocal report about the side of disease onset or bilateral motor involvement.
Effects of Plasmapheresis on Aging Biomarkers

The aim of the study is to evaluate the effect of plasmapheresis (repeated plasma withdrawals) on selected health indicators (hematological, biochemical, immunological and indicators of biological age) of plasma donors.


Eligibility Criteria:
Inclusion Criteria:

1. Generally healthy volunteer subjects age 40 - 60
2. 50:50 man and woman

Exclusion Criteria:

1. Subjects excluded from plasma donation protocols (serious illness, infection, etc)
2. Subjects undergoing stronger anti-aging interventions
GP2013 in Japanese Patients With CD20 Positive Low Tumor Burden Indolent B-cell Non-Hodgkin's Lymphoma

The purpose of this study is to evaluate safety and pharmacokinetic of GP2013 in Japanese patients with CD20 positive low tumor burden indolent B-cell NHL under weekly dosing schedule.


Eligibility Criteria:
Inclusion Criteria:

* Patient with CD20 positive low tumor burden indolent B-cell non- Hodgkin's lymphoma.
* Patient with at least one measurable lesion.
* Patient with ECOG performance status 0 or 1.

Exclusion Criteria:

* Patient who has received radiotherapy within the last 28 days prior to administration, or are not recovered from previous radiotherapy.
* Patient who has received immunotherapy, chemotherapy, antibodies and experimental treatment within the last 28 days prior to administration, or are not recovered from previous therapy.
* Patient who has mAb therapy other than rituximab as prior line of therapy.
* Patient with evidence of any uncontrolled, acute or chronic active infection (viral, bacterial or fungal).
* Patient with any other malignancy within 5 years prior to date of screening, with the exception of adequately treated in situ carcinoma of the cervix uteri, basal or squamous cell carcinoma or nonmelanomatous skin cancer.

Other protocol-defined inclusion/exclusion criteria may apply.
Effect of Continuous Invasive Blood Pressure Monitoring on Postinduction Hypotension in Patients Having Major Surgery

This is a randomized trial (1) investigating whether continuous invasive arterial blood pressure monitoring using an arterial catheter reduces the area under a mean arterial pressure (MAP) of 65 mmHg within the first 15 minutes of anesthetic induction compared to intermittent arterial blood pressure monitoring using oscillometry in patients having major surgery under general anesthesia; and (2) investigating the effect of continuous invasive arterial blood pressure monitoring using an arterial catheter on cardiac output, stroke volume, and heart rate within the first 15 minutes of anesthetic induction compared to intermittent blood pressure monitoring using upper-arm cuff oscillometry in patients having major surgery under general anesthesia.

not provided

Eligibility Criteria:
Inclusion Criteria:

Patients...

* at least 18 years of age
* scheduled for elective major surgery under general anesthesia that requires continuous invasive arterial blood pressure monitoring using a radial arterial catheter for clinical indications not related to the study

Exclusion Criteria:

* Clinical indication to insert the arterial catheter before anesthetic induction ("awake arterial catheter"; this is usually the case in patients with severe cardiovascular diseases, such as heart failure or left ventricular assist device)
* emergency surgery
* American Society of Anesthesiologists physical status classification V or VI
* need for femoral artery catheterization
* heart rhythms other than sinus rhythm.
Medial Branch Radiofrequency Ablation and Lumbar Multifidi

The purpose of this study is to evaluate the effects of lumbar medial branch radiofrequency ablation (RFA) on lumbar multifidi muscle size and clinical spinal stability. Specifically, this study is designed to highlight the comparison of multifidi muscle architecture using ultrasound imaging (USI) and MRI before and after lumbar medial branch RFA. This study will also include a commonly utilized functional assessment of the lumbar spine to evaluate the effects of RFA on lumbar spinal stability.

Radiofrequency ablation (RFA) for the lumbar spine (lower back) is a procedure used to treat lower back pain secondary to facet arthritis. The procedure ablates (burns) a small nerve that goes to the arthritic joint in the back. This nerve also innervates a muscle called the multifidus, thought to be important for lumbar stability. The investigators are conducting a study to evaluate if RFA has any impact on multifidi size, spinal stability, and overall function. The tools the investigators will be using to assess the multifidi muscles are musculoskeletal ultrasound, MRI, physical therapy assessment, and functional questionnaires. The goal of the study is to determine if RFA impacts the multifidi in a clinically significant fashion, causing atrophy, spinal instability, and/or functional decline.

Eligibility Criteria:
Inclusion criteria are:

* Aged over 18 years
* Presence of lumbar spondylosis or facet arthropathy (as determined by a radiologist) \*Unilateral back pain without radicular symptoms
* Positive physical findings for facet mediated pain (pain with lumbar extension and rotation to affected side)
* Ability to complete outcome measure forms.

Exclusion criteria are:

* Prior spinal surgery
* Prior RFA procedures
* Pregnancy
* Contraindications to MRI
* Presence of therapeutic anti-coagulation, medical co-morbidities that would interfere with the ability to perform the procedure safely
* Presence of neurologic changes
* Active tobacco smoking history
* Presence of active litigation
* Presence of open workers compensation case
Intrathecal Injection of Hyperbaric Bupivacaine Versus a Mixture of Hyperbaric and Isobaric Bupivacaine in Patients Undergoing Lower Abdominal Surgery

The aim of this study is to compare the effects of intrathecal injection of hyperbaric bupivacaine versus injection of hyperbaric and isobaric bupivacaine in patients undergoing lower abdominal surgery.

Spinal anesthesia is one of the most commonly used nerve block procedures for surgical operations involving the lower abdomen, the perineum, and the lower limbs, owing to its quick effect and cost-effectiveness. Spinal anesthesia is advantageous in that it uses a small dose of anesthesia, is simple to perform, and offers a rapid onset of action, reliable surgical analgesia, and good muscle relaxation.

The Baricity of a solution is defined as the ratio of the density of the solution to that of the cerebrospinal fluid (CSF). The most common anesthetic used for SA in obstetric and non-obstetric surgery is bupivacaine, which can be formulated as an isobaric or hyperbaric solution. Baricity differences between spinal anesthetic solutions are thought to affect hemodynamic parameters and distribution within the subarachnoid space, which may, in turn, affect the onset, extent, and duration of sensory block as well as side effects.

Spinal anesthesia has been linked to different adverse effects, out of which hypotension is most common complication. The incidence of hypotension is 25-75% in general population. Factors that increase the risk of hypotension include patient factors (advanced age, pregnancy, obesity, diabetes mellitus, hypertension, and anemia) and technical factors such as a block level at or above T5, use of opioids during premedication, and high local anesthetic dosages.

Eligibility Criteria:
Inclusion Criteria:

* Age between 18-65 years old.
* Both sexes.
* American Society of Anaesthesia (ASA) I to II.
* Undergoing lower abdominal or urological surgery under spinal anesthesia

Exclusion Criteria:

* Allergy to amide.
* Patients with a significant history of substance abuse.
* Patients with diabetes mellitus, neurological or cardiovascular diseases.
* Patients with neuromuscular diseases.
* Pregnant patients.
The Effects of Mixed Grain on Blood Glucose and Insulin in Healthy Male

This study was an open, 4-treatment, 5-sequence, 5-day cross-over randomized design clinical trial to evaluate the efficacy of mixed grain on blood glucose, insulin and Glycemic index(GI) in healthy males.

After a 12-hour fast, oral glucose or meal tolerance test was performed with blood samples drawn at time 0, 15, 30, 45, 90, 120, 150, and 180 min.

1. Serum levels of glucose, insulin, and C-peptide were analyzed by biochemical autoanalyzer. The area under the curve (AUC) changes in blood glucose were computed by the trapezoidal method.
2. Glycemic index(GI): the area under the glucose response curve after consumption of a test food divided by the area under the curve after consumption of a control food containing the same amount of carbohydrate and calculated using 50 g glucose as the reference.

Eligibility Criteria:
Inclusion Criteria:

* Males, 19\~60years old
* Bodyweight was more than 50 kg with ideal body weight within ±30%
* Less than 100 mg/dl in fasting blood glucose and less than 140 mg/dl in an oral glucose tolerance test (OGTT)
* Able to give informed consent

Exclusion Criteria:

* Major medical illness such as cardiovascular, neurologic, psychiatric, renal, pulmonary and hepatic diseases
* History of disease that could interfere with the test products or impede their absorption such as gastrointestinal disease or gastrointestinal surgery
* Medical or psychological conditions deemed by the investigators to interfere with successful participation in the study
* Poor vital sign (systolic blood pressure: below 100 mmHg or above 150 mmHg, diastolic blood pressure: below 65 mmHg or above95 mmHg)
* Allergic or hypersensitive to any of the ingredients in the test products; treated with any drug within past 2 weeks
* Participation in any other clinical trials within past 2 months
* Alcohol consumption above 21 units per week or abnormal screening laboratory test
* Being judged by the responsible physician of the local study center as unfit to participate in the study
Social Interactions Between People With Dementia in Nursing Home

The aim of this study is to evaluate the direct impact of one session of social stimulation on social interactions of people with moderate dementia living in nursing home in comparison of one session without direct social stimulation.

60 people with moderate dementia living in a french nursing homme participated in this study. Residents gave oral consent twice to participate. They were classified in groups of six residents taking into account socio-demographic and medical characteristics. Two experimental conditions were proposed : 1. a social stimulation session (36 residents) and 2. a control group without direct social stimulation (24 residents). Collected socio-demographic and medical characteristics are age, gender, timf of institutionalization, sociocultural level, marital status and diagnostic hypothesis. Before the study, scales and questionnaires were used to assess cognitive status with the Mini Mental State Examination (Folstein et al, 1975); functional abilities with Instrumental Activities of Daily Living (Lawton and Brody, 1969); depression with the Cornell Scale for Depression in Dementia (Alexopoulos et al, 1988); psychological and behavioural disorders with the Neuropsychiatric Inventory (Cummings et al, 1994); and the quality of life with the Alzheimer's Disease Related Quality of Life (Rabins et al, 1999).

Social interactions are video taped and analyzed in a grid of observation.

The aim of the study is to see if there is an impact on social interactions after just one social stimulation session compared to a control group situation. Expected results are that residents of the social stimulation group will have more social interactions between us than the resident of the control group.

Eligibility Criteria:
Inclusion Criteria:

* presence of a diagnostic of dementia in medical report and a MMSE score between 9 and 20.

Exclusion Criteria:

* arrival in the institution dating less than six months
* invalidating visual or hearing disorders
* phasic disorders not allowing a minimum of communication
* significant behavioural disorders (which can disturb the meeting)
* residents not fluent in French language
The Effects of Stromal Vascular Fraction and Mesenchymal Stem Cells as Intra-articular Injection in Knee Joint Osteoarthritis

Osteoarthritis of the knee is one of the most common causes of disability among elderly. As the disease progresses the cartilage become frustrated, surrounding bone react to become thicker and inflammation occurs in subchondral bone seen in T2-weighted MRI as increase in signal density. Patients are treated initially by pain management. In patients who don't response to first line treatment invasive treatment like total knee replacement is done. The investigators designed this clinical study with the aim of evaluating therapeutic effects of intra-articular injection of bone marrow Mesenchymal Stem Cells (MSC) and stromal Vascular Fraction (SVF) in patients with severe knee osteoarthritis

This is single center, randomized, triple blind phase II clinical study. Patients will be divided into two groups of case and control. All subjects will undergo bone marrow aspiration. Mesenchymal Stem Cells will be isolated from bone marrow and stromal Vascular Fraction fram lipoaspirate, cultured and transplanted back to the knee joint. Patients of case group will receive cell injection 1 and 4 months after bone marrow aspiration. Placebo will be administered in this group 6 months after the first injection. Patients of control group will receive placebo 1 and 4 months after bone marrow aspiration. They all receive cell injection 6 months after first placebo injection. Follow up visit will occur at 2 and 6 weeks, and 3 and 6 months after the first injection. Radiological exams will be performed before and 6 months after the first injection by MRI. Clinical quantitative assessment will measure joint function by the WOMAC index and pain by the visual analogue scale

Eligibility Criteria:
Inclusion Criteria:

* Osteoarthritis diagnosed by MRI

Exclusion Criteria:

* Pregnancy or lactating
* Positive tests for HIV, Hepatitis C virus (HCV), Hepatitis C virus (HBV)
* Active neurologic disorder
* End organ damage
* Uncontrolled endocrine disorder