cyrilzakka/clinical-trials huggingface dataset:
Self-Management for Anxiety, Depression and Somatoform Disorders

Anxiety, Depression and Somatoform disorders are highly prevalent in primary care. Very often these conditions remain undiscovered and/or untreated.

In order to ease this urgent health care problem in the future, the investigators conduct a cluster-randomized controlled trial, implementing a tandem working cooperation between a nurse practitioner (Counseling Assistant - CA) and a general practitioner (GP) on-site its own practise.

The CA's task is to enhance the patients abilities to engage in a better self-management of their psychological symptoms and complaints, to enhance self-efficacy and empower the patients to tackle problems of daily living.

Anxiety, Depression and Somatoform disorders are highly prevalent in primary care. Very often these conditions remain undiscovered and/or untreated. Managing it is time-consuming and communication-intensive. Furthermore, the management is restraint by the high contact-frequencies in primary care practices in Germany.

In order to ease this urgent health care problem in the future, the investigators conduct a cluster-randomized controlled trial, implementing a tandem working cooperation between a nurse practitioner (Counseling Assistant - CA) and a general practitioner (GP) on-site its own practise.

The CA's task is to enhance the patients abilities to engage in a better self-management of their psychological symptoms and complaints, to enhance self-efficacy and empower the patients to tackle problems of daily living.

Eligibility Criteria:
Inclusion Criteria:

* Patients scoring \>= 5 on the Patient Health Questionnaire (German Version), corresponding to a probable or established diagnosis of Anxiety, Depression or Somatoform Disorder

Exclusion Criteria:

* Negation of Inclusion Criteria
Lutein Supplementation in Healthy Children

This is a single site, randomized, double-blind placebo controlled parallel arm study assessing the effects of 6 months lutein supplementation on cognitive and visual outcomes in healthy children exposed to excessive digital screen time.

Studies in humans and primates have also shown that appropriate daily intake of lutein provides protection to the eyes from blue light from screen time devices such as computers, televisions and phones. It has been well-documented that children are spending far over the recommended two hours screen time per day and excessive exposure to the high energy blue light associated with digital devices has been shown to cause both short-term and long-term visual damage as well as disruption to the sleep cycle. With a globally aging population, if this deficit is not addressed adequately early on in life then there will be substantial public health consequences. A recent study predicted that if individuals were to consume the recommended levels of lutein and zeaxanthin daily, there would be a seven percent reduced risk for age related eye disease and a potential savings of over five billion US dollars annually.

Eligibility Criteria:
Inclusion Criteria:

* Age of 8 to 16 years
* guardian-reported general good health
* guardian-reported 4 hours or more of digital screen time daily

Exclusion Criteria:

* Currently using a supplement containing lutein or zeaxanthin
Validating Wireless Gait Sensor for Elderly Fall Risk Classification

The walking status of elderly patients over 65 years of age in the hospital will be verified through political analysis and objective fall risk assessment through wireless inertial sensors and diagnostic machine learning models, and based on the results, As investigators, providing a foundation for the objective evaluation of the risk of falling patients by nurses in general wards in the future.

Currently, in the case of general clinical wards in Korea, the evaluator who assesses the risk of falling during the patient's hospitalization changes every time, and the evaluation of fall risk differs for the same patient depending on the subjectivity of the evaluator. Hence, evaluating falls requires assessing the patient's walking based on consistent criteria. Through walking analysis with a wireless small inertial sensor, there is an expectation that the incidence of fall risk will decrease. When analyzing walking to classify fall risk groups, quantitative evaluation should be applied for stride length, gait speed, step width, cadence, and gait cycle, but currently, fall assessments taking this into account are not properly conducted. Therefore, it is necessary to prepare and apply quantitative standards for fall evaluation through walking analysis through wireless small inertial sensors and data machine learning to classify the risk of falling in elderly hospitalized patients.

Eligibility Criteria:
Inclusion Criteria:

1. a person over the age of 55
2. Persons who can walk independently for at least one minute
3. Those who do not take drugs that affect their ability to maintain balance
4. A person who does not have an orthopedic problem such as a fracture of the lower extremities within six months

Exclusion Criteria:

1. Those who have difficulty understanding the gait analysis program or difficulty expressing symptoms
2. A person deemed unfit for this study by a rehabilitation specialist due to other conditions
3. A person who is unable to apply this walking analysis program due to serious cardiovascular diseases
Botulinum Toxin Efficiency on Spasticity of Rectus Femoris and Semitendinosus Muscles as Functional Agonist and Antagonist Muscles

The aim of the study is to confirm the functional improvement obtained through treatment of spasticity on 2 agonist and antagonist muscles. The hypothesis is that treatment of both muscles gives a better and longer functional improvement than treatment of only one muscle. The target muscles are the rectus femoris and semitendinosus and the treatment is botulinum toxin. Clinical assessment (passive range of motion of the lower limbs, spasticity level, functional scales and subjective feeling) and gait analysis data (kinematics and kinetics data) are collected. Evaluations take place before treatment, 2 months and 6 months after treatment.


Eligibility Criteria:
Inclusion Criteria:

* Patients between 7 to 17 years old
* Cerebral palsy children with walking ability (even with crutch or knee-walker) allowing gait analysis.
* Patients with functional status allowing the use of botulinum toxin on target muscles.

Exclusion Criteria:

* Patients under 7 years old
* Patients up to 17 years old
* Patients in whom botulinum toxin is contra-indicated
* Patients who received botulinum toxin within a 6 month period before the beginning of the study
MOrphometric MRI Analysis of Cortical Sulci: Development of NEurodevelopmental Biomarkers of Bipolar Disorder.

Given the phenotypic heterogeneity of bipolar disorder, it seems essential to propose new methodologies to improve the stratification of this pathology in order to describe more homogeneous groups of patients. In this perspective, the neurodevelopmental hypothesis of bipolar disorder seems promising. Brain sulcation is an indirect marker of neurodevelopmental processes. The objective of the study is to highlight sulcal variations between a group of bipolar patients with a neurodevelopmental phenotype (ND) and a group of bipolar subjects without a ND phenotype. A sulcation marker (GPR56) will also be measured from patient blood samples. In order to carry out this project we would like to include 120 participants for a period of 12 months.


Eligibility Criteria:
Inclusion Criteria:

For the "neurodevelopmental" group :

The volunteer has at least 2 of the 12 neurodevelopmental criteria

For the "non-neurodevelopmental" group The volunteer does not present any of the 12 neurodevelopmental criteria

List of the 12 neurodevelopmental criteria :

1. The volunteer had at birth a paternal age ≥ 40 years
2. The volunteer had at birth a maternal age ≥ 35 years
3. The volunteer was born by cesarean section
4. The volunteer had a history of perinatal infection
5. The volunteer has a history of generalized anxiety disorder that began before the age of 16 (≤ 15 years)
6. The volunteer has a history of an eating disorder that began before the age of 16 (≤ 15 years)
7. The volunteer has a history of a substance use disorder (excluding tobacco) as described in the DSM-5 prior to age 16 (≤ 15 years)
8. The volunteer has a learning disability or "dys" disorder as defined in the DSM-5 or number of repeats \> 2
9. The volunteer has a history of trauma assessed as severe by the CTQ self-assessment questionnaire
10. The volunteer has symptoms suggestive of Attention Deficit Hyperactivity Disorder (WURS score \> 46)
11. The volunteer has a history of psychotic features during episodes.
12. The volunteer has an early age of onset of bipolar disorder at an age below 18 years.

Exclusion Criteria:

* Serious symptomatic or unstable physiological or medical condition (including pregnancy)
* History of stable or non-stable psychiatric illness, schizophrenia or any other condition that may interfere with bipolar disorder
* History of comorbid autism spectrum disorder
* History of severe head injury (GCS\<8 at time of injury)
* Neurological disorder affecting central nervous system function
* Moderate to severe substance use disorder (\>=4/11 as defined in the DSM-5) with the exception of tobacco use disorder
* Under court protection or guardianship
* Unable to give the volunteer informed information, or the volunteer refuses to sign the consent form
* Insufficient command of the French language to complete the assessments
* Has a contraindication to MRI
A Community Health Worker Home Intervention to Improve Pediatric Asthma Outcomes

The investigators propose to test the hypothesis that a home-based asthma intervention, the Wee Wheezers program, delivered by the Community Health Workers and tailored to the needs of the investigators community, will improve anti-inflammatory medication adherence, parental asthma knowledge and management behaviors, which in turn will reduce asthma morbidity (defined as days with asthma symptoms) and health care utilization (defined as asthma-related Emergency Department visits) among low-income, minority children with persistent asthma in the Bronx.

Asthma disproportionately burdens low-income inner city and minority children residing in inner cities. Daily use of inhaled corticosteroids (ICS) control symptoms and reduce asthma morbidity. Less then 50% of children with persistent asthma adhere to such therapy. Poor adherence to ICS medications is one of the major contributors to asthma morbidity. One way to reduce asthma disparities is to work in partnership with communities. Community Health Workers (CHWs) share the ethnic, cultural, social, and environmental experiences of the people in the community. Although, CHW home interventions have been successful in reducing asthma allergens, no studies using CHWs to deliver a previously identified evidence-based home intervention to improve ICS adherence and health outcomes in a population of inner-city, minority children with persistent asthma have been found. Objective: To evaluate the effectiveness of an evidence-based asthma home intervention, the Wee Wheezers program, tailored to the needs of the community and delivered by CHWs, in improving medication adherence, health outcomes and parental management behaviors among low-income, minority children with persistent asthma in the Bronx.

Eligibility Criteria:
Inclusion Criteria:

* children 2-9 years of age with persistent asthma
* children being currently prescribed ICS in the Metered Dose Inhaler (MDI) form
* if the child is 2 years of age at the time of the recruitment, he/she must have at least two prior episodes of wheezing treated and reversible with beta-agonists
* primary caregiver speaks English or Spanish
* family has a phone.

Exclusion Criteria:

* children with other chronic pulmonary diseases (e.g, cystic fibrosis, bronchopulmonary dysplasia) or presence of tracheostomy
Hypoglycemia and Autonomic Nervous System Function- B2

We will study the effect of hypoglycemia (low blood sugar) on baroreflex sensitivity in participants with well controlled type 2 diabetes.

Participants are admitted for two days and two nights to an inpatient clinical research center for performance of study procedures. On Day 1, two hyperinsulinemic hypoglycemic (50 mg/dl) clamps are performed - an AM clamp from about 9 to 11 am and a PM clamp from about 1 to 3 pm.. Modified Oxford procedures are performed in duplicate at five time points -- before the AM clamp, during the AM clamp, before the PM clamp, during the PM clamp, and the morning of Day 2 (about 16 hrs after completion of the the PM clamp). The Modified Oxford procedure involves the sequential intravenous administration of nitroprusside and phenylephrine with assessment of blood pressure and heart rate by finapress. Baroreflex sensitivity is the relationship of changes in heart rate to changes in blood pressure. .

Eligibility Criteria:
Inclusion Criteria:

* Males and females age 18 to 55 years
* Type 2 Diabetes Mellitus controlled by diet, exercise and non-insulin glycemic control agents (metformin, thiazolidinediones, sulfonylureas, dipeptidyl peptidase-4 inhibitors, sodium-glucose co-transporter 2 inhibitors, alpha-glucosidase inhibitors or glucagon-like peptide-1 receptor agonist) or basal insulin at doses less than or equal to 0.3 units/ kg per day.

Exclusion Criteria:

* Hemoglobin A1c \> 9% for type 2 diabetes
* Recurrent hypoglycemic episodes within the past month
* BMI \< 25 or \> 42 (Type 2 diabetes only)
* Pregnancy
* Lactation
* Clinically significant coronary artery, cerebrovascular, or peripheral vascular disease, or presence of systemic illness that might affect autonomic function. Such illnesses include congestive heart failure, renal, pulmonary, hepatic disease, anemia, malignancies, untreated thyroid disease, and alcoholism.
* Current major depressive illness
* In all subjects, any individuals on oral, injected, inhaled or topical corticosteroids within the last year or oral contraceptives within the past 3 months will be excluded.
* Known hypersensitivity to nitroglycerin, nitroprusside and/or phenylephrine.
* Blood pressure \> 160/100 mmHg (applies to participants with T2 diabetes)
* Creatinine \> 1.5 mg/dL
* Serum potassium \>5.2 mmol/L
* Estimated GFR \< 50 mL/min
* Use of Viagra, Cialis, and similar drugs within 72 hours of admission.
* Use of beta-blockers or mineralocorticoid receptor antagonists
Ischemic Conditioning During Air tRansport Save penUmbral Tissue

The purpose of this study is to demonstrate the feasibility of performing remote limb ischemic conditioning (RLIC) using the Doctormate device, a special blood pressure device used to perform RLIC, on patients with acute ischemic stroke due to large vessel occlusion being transported to a thrombectomy capable center by the helicopter.

In this study, 15 subjects presenting to a community hospital with signs and symptoms of ischemic stroke due to large vessel occlusion, transported to a comprehensive stroke center by aircew will receive RLIC using the Doctormate device.

The RLIC treatment will consist of 3-5 cycles ( depending on transportation time) of 5 minutes inflations of both blood pressure cuffs simultaneously. Blood pressure will be 200 mm HG with 5 minutes of reperfusion between each inflation.

Subjects will be evaluated upon arrival to the comprehensive stroke center and evaluated for side effects.

The study will be conducted at one site ( University of Iowa Hospitals and Clinics)

Eligibility Criteria:
Inclusion Criteria:

1. Age ≥18 and ≤ 80 years
2. Suspected acute ischemic stroke with symptoms suggestive of large vessel occlusion (aphasia, agnosia, neglect, visual field cut, and gaze preference).
3. Patient screened for rtPA, and rtPA administered if eligible
4. Subject or legally authorized representative able to provide consent at the time of the assessment
5. NIHSS 6-20

Exclusion Criteria:

1. Any intracranial hemorrhage (parenchymal, subarachnoid, subdural, epidural) on CT scan at the community hospital
2. History of upper or lower extremity ischemia, known subclavian, brachial artery, iliac or femoral artery stenosis, subclavian steal syndrome, any upper or lower extremity soft tissue, orthopedic or vascular injury, or mastectomy or other procedure that may contraindicate taking blood pressure or having a cuff on the arm or leg for the conditioning treatment
3. History of diabetes mellitus
4. Enrollment in another clinical trial
5. Patient incarcerated
6. Pregnancy. Patients ages 18-55 will need to have a negative urine or blood based pregnancy test.
7. Agitation deemed unsafe for ischemic preconditioning testing.
8. Arteriovenous fistula in upper limb
Evaluation of GEMCITEST in Patients With Pancreatic Cancer and Treated by Chemotherapy

Pancreatic cancer has a 5-year overall survival rate around 5%. It is the 6th most common cancer in France (11 600 new annual cases in 2012) and the 4th leading cause of cancer deaths in France and Europe.

Many translational research has tried to identify biomarkers in pancreatic cancer. Only the expression of hENT1 evaluated on the tumor tissue with the mouse antibody seems really relevant by providing a predictive value of the effectiveness of gemcitabine adjuvant. In a metastatic situation, there is no predictive marker of the effectiveness of chemotherapy treatments.

GemciTest(TM), studied in this study, is developed by the company Acobiom. Test based on the qRT-PCR technology that allows the establishment of a molecular signature of 10 genes that showed its interest as a biomarker in 60 patients with metastatic pancreatic adenocarcinoma treated with gemcitabine. Retrospective analysis differentiated 2 patient populations:

* 22 patients with a "favorable" expression gene with a median survival of 14.9 months
* 35 patients with an "adverse" expression gene with a median survival of 5.1 months

Primary objective: To evaluate in patients with pancreatic cancer, treated with Gemcitabine alone or combined (nab-paclitaxel) or with Folfirinox, the prognostic value of the GemciTest(TM) test on overall survival and response to treatment.

To realize this study, only one 2.5 mL blood sample is taken before starting chemotherapy. The standard practice data is then saved.

100 patients will be included.


Eligibility Criteria:
Inclusion Criteria:

1. Cytologically or histologically confirmed pancreatic cancer
2. Patient seeking first-line chemotherapy for pancreatic cancer
3. Age\> 18 years
4. Presence of at least 1 measurable tumor lesion according to RECIST 1.1 criteria
5. Performance index ≤ 2
6. Patient able and willing to comply with the study procedures according to the protocol
7. Patient able to understand, sign and date informed consent
8. Affiliation to a social security scheme.

Exclusion Criteria:

1. Contraindication to chemotherapy
2. Anti-tumor therapy, experimental or not, recent in the last 4 weeks before the inclusion of the patient
3. Active infection requiring antibiotics within 14 days before inclusion
4. Patients unable to understand, read and / or sign informed consent
5. Persons benefiting from a protection system for adults (including tutorship and guardianship)
6. Pregnant or lactating women
Pilot Testing a New Pregnancy Decision Making Tool for Women With Physical Disabilities

The purpose of this project is to develop, and pilot test a decision-making tool that is tailored for women with physical disabilities to support those women in making a decision about whether or not a pregnancy is right given the participant's situation.


Eligibility Criteria:
Inclusion Criteria:

* Physical disability, defined by loss or impairment of physical function limiting one or more important life activities
* Mild, moderate or severe disability severity; severity will be assessed based on the need for assistance with daily life activities and/or personal care
* Actively planning or in the process of making a decision about whether or not to get pregnant in the near future.
Localized Therapeutics for the Treatment of Gastrointestinal Disorders

The purpose of this study is to determine the patient preference for a biocompatible thermosensitive solution-gel versus water or saline (liquid) enema. The thermosensitive solution-gel is comprised of poloxamer, an inactive compound that is designated as GRAS (generally recognized as safe) by FDA. It could subsequently be used as a medium for drug delivery. The poloxamer (gel) is administered to study participants in order to assess preference and proximal distribution.


Eligibility Criteria:
Inclusion Criteria:

* Generally healthy
* Age 18 to 70 years old
* Non-pregnant

Exclusion Criteria:

* GI complaints
* Pregnancy
* Patients with previous colonic surgery or current bowel injury or obstruction
* Allergies to contrast
HPI Effect in Robotic Urological Surgery on AKI

It is a single-center randomized controlled trial that aims to figure out the effect of the hypotension prediction index (HPI) on the prevention of acute kidney injury (AKI) after robot-assisted urological surgery. The primary hypothesis is that HPI software guidance prevents postoperative AKI by reducing the duration and severity of intraoperative hypotension (IOH).


Eligibility Criteria:
Inclusion Criteria:

* Age ≧ 19
* Patients undergoing robot-assisted urological surgery

Exclusion Criteria:

* Unable to voluntarily give consent
* Unable to use both radial arteries due to such reasons: prior surgery on the radial artery, breast cancer history with axillary LN dissection, AV fistula for renal replacement therapy, or abnormal Allen's test.
A Study to Evaluate the Pharmacokinetics and the Safety After Administration of "BR1017-1" and Co-administration of "BR1017-1A" and "BR1017-1B"

The objective of this clinical study is to evaluate the pharmacokinetics and the safety after administration of "BR1017-1" and co-administration of "BR1017-1A" and "BR1017-1B" in healthy volunteers


Eligibility Criteria:
Inclusion Criteria:

* Those who weigh 50 kg or more and have body mass index (BMI) within the range of 18.0 to 30.0kg/m² at screening visit.
* Those who sign written consent spontaneously after listening to and understanding sufficient explanation of the purpose and contents of this clinical trial, characteristics of the Investigational products, expected adverse events, etc.

Exclusion Criteria:

* Those who have taken drugs that induce and inhibit metabolizing enzymes such as barbiturate within 30 days prior to the first day of administration or have taken drugs concerned about affecting this clinical trial within 10 days prior to the first day of administration. (however, participation is possible considering pharmacokinetics and pharmacodynamics such as Interaction of investigational products, half-life of concomitant drugs, etc.)
* Those who have participated in other clinical trials(including bioequivalence tests) and administered their investigational products within 6 months prior to the first administration date.(However, the termination for participation in other clinical trials are based on the last administration date of their investigational products)
* Those who have a medical history of gastrointestinal surgery or gastrointestinal diseases that may affect the absorption of drugs. (Except for simple appendectomy, hernia surgery)
* Those who can't discontinue a diet (ex. raw grapefruit, grapefruit juice or its products) that may affect the absorption, distribution, metabolism, and excretion of the drug within 48 hours prior to the first day of administration.
* In the case of a female subject, those suspected pregnancy, pregnant woman, lactating woman.