cyrilzakka/clinical-trials huggingface dataset:
Neuropsychological Functioning in Children With Attention-Deficit/Hyperactivity Disorder.

The purpose of this study is to evaluate the change in neuropsychological status from baseline to 6 months post-initiation of atomoxetine treatment in children ages 6 to 10.5 diagnosed with ADHD.


Eligibility Criteria:
A) Patients:

Inclusion Criteria:

1. Patients must have ADHD, be outpatients, who are at least 6 years of age and not more than 10 years 6 months of age at Visit 1 so that all testing will be completed before the child reaches age 11.
2. Patients must have moderately severe symptoms of ADHD.
3. Patients must be able to swallow study drug capsules.

Exclusion Criteria:

1. Patients must not have Bipolar disorder, psychosis, autism, Asperger's syndrome, pervasive developmental disorder, or seizure disorder.
2. Patients must not be home-schooled.

B) Controls:

Subjects will be recruited by the investigator, age and gender-matched to the atomoxetine-treated patients.

Inclusion Criteria:

1) Control subjects must be assessed to be not diagnosed with a psychiatric disorder or a medically significant disorder

Exclusion Criteria:

1) Subjects must not be home-schooled.
Characteristics of a Maxillofacial Prosthesis Consultation Within Assistance Publique - Hopitaux de Paris

Patients treated with Maxillofacial Prosthesis have loss of maxillary and/or mandibular substances. Few data are available on quality of life of these patients and its association with some of their socio-demographic, medical and clinical characteristics.

Patients treated with Maxillofacial Prosthesis have loss of maxillary and/or mandibular substances (oral-nasal or oral-sinusal communication, removal of the soft palate, removal of part of the lower jaw). These losses are mainly due to the surgical consequences of cancers of the upper aerodigestive tract, trauma or sequelae of labio-palate clefts. Depending on the etiology of substance loss, there are 3 main therapeutics: surgical approach, radiotherapy and chemotherapy. The effects of these treatments are functional, aesthetic and psychological. The functions impacted are chewing, phonation, ventilation and swallowing.

Few data are available on quality of life of these patients and its association with some of their socio-demographic, medical and clinical characteristics (drug use, type of maxillo-mandibular loss of substance, disorder(s) associated with substance loss, ...).

This study investigates the socio-demographic, medical and quality of life characteristics of Maxillofacial Prosthesis consultation's patients (Department of Dentistry, GHPS) and the potential associations between quality of life and some of these characteristics.

Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 18 years old
2. Patients consulting for Maxillofacial Prosthesis management (Dental Department, Pitié-Salpêtrière Hospital Group)
3. Information and collection of the patient's non-opposition to participation in the research
4. Good written and oral comprehension of the French language

Exclusion Criteria:

1. Under guardianship or curatorship
2. Cognitive disorders: confounding, impaired memory, attention, reasoning and/or judgment
Observational Study for the Evaluation of Immune-mediated Endocrinological Adverse Events in Patients with Hematological Malignancies and Subjected to Treatment with Immune-checkpoint Inhibitors

Retrospective / prospective observational study of endocrinological adverse events in hematologic patients treated with immunological checkpoint inhibitors


Eligibility Criteria:
Inclusion Criteria:

Retrospective cohort

* patients aged\> 18 years
* cyto-histological diagnosis of mature lymphoproliferative syndrome of B or T lymphocyte origin
* advanced stage of illness (relapsed or refractory)
* patients undergoing treatment with immune anticheckpoint antibodies.
* written informed consent

Prospective cohort

* patients aged\> 18 years
* cyto-histological diagnosis of mature lymphoproliferative syndrome of B or T lymphocyte origin
* advanced stage of illness (relapsed or refractory)
* patients who are candidates for therapy with anticheckpoint immune antibodies (it is specified that this therapy is completely independent of the subject's participation in the study).
* written informed consent

Exclusion Criteria:

* Severe, acute and chronic medical or psychiatric disorders that may affect the interpretation of the study results or interfere with it.
Nalmefene Smoking Cessation Study

To determine if nalmefene is safe and effective in smoking cessation.

Single centered, randomized, placebo-controlled,double-blind, outpatient pilot study to evaluate the efficacy, safety and tolerability of 2 doses of nalmefene on smoking cessation.

Eligibility Criteria:
Inclusion Criteria:

* Smokers in good general health self reporting more than 15 cigarettes per day

Exclusion Criteria:

-
Standardization of Surgery on the Pancreatic Cancer

This study was designed to test the hypothesis that more extensive nodal and soft-tissue clearance in patients with adenocarcinoma of the head of the pancreas would improve survival without an increase in morbidity and mortality.

In Japan and in some western treatment centers, there has been a general belief that more extensive surgery may improve outcome for patients with localized, operable pancreatic adenocarcinoma. Initial retrospective reports from centers in Japan suggested that 5-year overall survival rates in patients treated with pancreaticoduodenectomy plus extended lymphadenectomy were higher than those in patients treated by pancreaticoduodenectomy with standard lymphadenectomy. Subsequent prospective randomized trials performed in Europe and the United States failed to confirm a survival benefit from extended lymphadenectomy. Although they failed to confirm a survival benefit from extended lymphadenectomy, the studies had a few pitfalls. The need for Well-designed randomised controlled study is the starting point of our study. This study was designed to test the hypothesis that more extensive nodal and soft-tissue clearance in patients with adenocarcinoma of the head of the pancreas would improve survival without an increase in morbidity and mortality.

Eligibility Criteria:
Inclusion Criteria:

* Age : 20- 85 years old
* No evidence of metastasis and to be possible to resect radically
* No history of previous radiation therapy or chemotherapy
* Pathological diagnosis: adenocarcinoma of pancreas
* Patients who agree and sign the informed consent
* More than 70 in Karnofsky performance scale

Exclusion Criteria:

* Past medical history of treatment for other malignant disease
* Recurred pancreatic cancer patients
* Patients with R1/R2 resection
* Patients who underwent neoadjuvant chemotherapy
Evaluation of PROCHYMAL® Adult Human Stem Cells for Treatment-resistant Moderate-to-severe Crohn's Disease

Protocol 603 is enrolling subjects with moderate-to-severe Crohn's disease who are intolerant to, or have previously failed therapy with, at least one steroid and at least one immunosuppressant and a biologic monoclonal anti-body to tumor necrosis factor alpha. The protocol investigates the safety and efficacy of using PROCHYMAL® adult human stem cells to induce remission. PROCHYMAL is delivered through a vein in the arm four times over two weeks, for approximately an hour each time.

A significant number of individuals with Crohn's disease do not find relief with existing steroidal, immunosuppressive, or biologic therapies, and are forced to seek surgery or other drastic measures for treatment.

PROCHYMAL® adult human stem cells are manufactured from healthy, volunteer donors, extensively tested, and are stored to be available as needed. Human and animal studies have shown that the cells do not require any donor-recipient matching. The cells may have both immunosuppressive and healing benefits in Crohn's disease. The cells naturally migrate specifically to sites of inflammation, so their effects are believed to be local and self-limiting rather than systemic.

Protocol 603 is enrolling subjects to evaluate the ability of PROCHYMAL to induce remission in subjects with moderate-to-severe disease (Crohn's disease activity index -- CDAI -- of between 250 and 450, inclusive) who have failed or been intolerant of at least one drug in each of the steroid, immunosuppressant, and biologic classes.

Eligibility Criteria:
Inclusion Criteria:

* failed (within last 2 yr) or intolerant of at least one steroid AND at least one immunosuppressant AND at EXACTLY one biologic
* CDAI between 250 and 450, inclusive
* endoscopically or radiographically confirmed Crohn's disease of ileus or colon or both
* C-Reactive Protein Test (CRP) of at least 5 mg/l (0.5 mg/dl)\*OR\* CDAI of at least 300
* weight between 40 and 150 kg, inclusive
* adequate renal function
* negative tuberculosis skin (PPD) test (or evaluated low risk of TB activation)

Exclusion Criteria:

* HIV or hepatitis infection active
* allergy to CT contrast agents, or to bovine or porcine products
* symptomatic fibrostenotic Crohn's disease
* permanent ostomy
* biologic therapy within past 90 d
* prednisone greater than 20 mg/d within past month
* short-bowel syndrome
* total parenteral nutrition
* abnormal liver function
* malignancy active within past 5 years (except completely resected basal or squamous cell carcinoma of skin)
* enteric pathogens, including C. difficile
* history of colonic mucosal dysplasia
* current or prior evidence of tuberculosis (TB) (unless risk of activation or re-activation deemed low)
Immunointervention With Calcitriol in New-Onset Type 1 Diabetes

This is a randomized, two-arm, placebo-controlled phase-2 trial to determine whether the daily intake of 1,25-dihydroxy-vitamin D3 \[1,25(OH)2D3\], improves beta cell function in patients with recently diagnosed type 1 diabetes. The treatment consists of the daily oral administration of 0.25 µg 1,25(OH)2D3 or placebo for 9 months and an equal follow-up time without supplementation. Fasting, peak and AUC C-peptide concentrations during a 2-hour mixed meal tolerance test are measured at the beginning of the study, as well as at the end of the treatment and the follow-up period in month 9 and 18. The null hypothesis is that there is no difference between 1,25(OH)2D3 treated subjects and the placebo group in the AUC C-peptide at month 18.


Eligibility Criteria:
Inclusion Criteria:

* New onset Typ 1 diabetes (\< 6 weeks insulin therapy)
* Age 18-39 years
* GADA and/or IA-2A positive

Exclusion Criteria:

* Kidney disease
* Pregnancy
* Lactating
Aerobic Exercise and Covid-19 Survivors With Post-Intensive Care Syndrome (Pics)

To investigate the effects of aerobic exercise program on physical activity, aerobic capacity, anxiety\& depression in Covid-19 survivors discharged from Intensive Care Unit. There is evidence in the literature that post-intensive case survivors who have been mechanically ventilated will likely experience short- and medium-term consequences in the form of Post Intensive Care Syndrome (PICS).

The notion that patients surviving intensive care and mechanical ventilation for several weeks can be discharged home without further medical attention is a dangerous illusion. Post-Intensive Care Syndrome and other severe conditions will require not only adequate screening but early rehabilitation and other interventions. So, this focused control trial will contribute particularly to determining the Effects of the Aerobic Exercise Program in Covid-19 Survivors with Post-Intensive Care Syndrome.

Eligibility Criteria:
Inclusion Criteria:

* Patients undergo mechanical ventilation in the ICU.
* Recovered from Covid-19 \& Discharged from ICU within the past 2 months.
* Hospital Anxiety and Depression Scale (HADS)\>8.
* Scale≥ 2 on MRC Dyspnoea Scale.
* Subjects consenting to participate in the study.

Exclusion Criteria:

* Positive Covid-19 Test.
* COPD and other respiratory diseases.
* Pre-existing psychotic dementia-type illness.
* Acute neurologic diseases (meningitis, ischemic hemorrhagic stroke).
* Patients with chronic systemic disease.
Evaluation of the Influence of Output on Skin Wearing a New Adhesive

The purpose is to investigate the impact real output has on the peristomal skin covered by a newly developed adhesive.


Eligibility Criteria:
Inclusion Criteria:

1. Have given written informed consent
2. Be at least 18 years of age and have full legal capacity
3. Have had a stoma for more than one year
4. Have intact skin on the area used in the evalua-tion
5. Has a stoma with a diameter up to (≤) 35 mm
6. Have a peristomal area accessible for application of patches/adhesive strips (assessed by investigating scientist)

Exclusion Criteria:

1. Currently receiving or have within the past 2 month received radio- and/or chemotherapy
2. Currently receiving or have within the past month received topical steroid treatment in the peristomal skin area or systemic steroid (tablet/injection) treatment.
3. Are pregnant or breastfeeding
4. Having dermatological problems in the peristomal- or abdominal area (assessed by investigating scientist)
5. Actively participating in other interventional clinical investigations or have previously participated in this investigation.
Biometrical Evaluation of the Efficacy of a Food Supplement Versus Placebo

The purpose of this clinical trial is to evaluate whether nutritional supplementation over a 2-month period improves skin physiological parameters. This is a national, single-center, double-blind, randomized pilot study.

The study will be conducted using a supplement and a placebo, the safety of which has been assured by the sponsor.

Participants will:

* Take a food supplement or a placebo once daily for 2 months
* Visit the study center at beginning, after 28 days and after 56 days of supplementation.
* Keep a diary of their skin status and tolerability

The secondary objective is to evaluate product characteristics and performance during normal use in healthy subjects.


Eligibility Criteria:
Inclusion Criteria:

* Phototype: I to IV;
* Subjects with normal to dry skin;
* Subjects with healthy skin on the study area;
* Non-smokers;
* Has normal nutritional habits (not vegetarian/vegan);
* Is not pregnant or lactating;
* Has a BMI of 18 - 33 kg/m2;
* Is willing to refrain from taking dietary supplements (at best not at all, in any case not during the last month before study start);
* Willing not to use any oral products or any nutritional supplementation aiming at improving skin status during the course of the study;
* No history of malabsorption diseases, liver diseases, or diseases of the lipid metabolism;
* Uses no medication, which may interact with the study product

Exclusion Criteria:

* For women: pregnant or nursing woman or woman planning to get pregnant during the study;
* Cutaneous pathology on the study zone (eczema, etc.);
* Subject with make-up on the day of the visit at the laboratory;
* Use of topical or systemic treatment during the previous weeks liable to interfere with the assessment of the efficacy of the study product:

  * change in anti-wrinkle, smoothing and/or firming topical products within previous week on the studied zones,
  * non-invasive procedures within previous month on the studied zones,
  * intake of food supplement acting on skin within the three previous months,
  * invasive procedures:

    * deep chemical peeling within previous 3 months on the studied zones,
    * mesotherapy, dermapen, laser within previous 6 months on the studied zones,
    * botox and/or hyaluronic acid injections within previous 12 months on the studied zones;
* Intake of vitamin substances and diets comprising a change of normal eating habits;
* Known allergy to one or several investigational product´s ingredients;
* Participation in a nutritional study within the last 30 days;
* Surgical or internal diseases e.g. a metabolic or endocrine disease that may affect the outcome of the study (e.g. diabetes, liver diseases, kidney disorders) or having a history of medical or surgical events that may significantly affect the study outcome including any cardiovascular disease, skin disease, hypertension (\>140/90 mm Hg in three repeated measurements).
Cognitive Effects of Immunomodulatory Drugs in MS

The purpose of this study is to examine and compare changes in the specific thinking skills of patients with RRMS who are receiving treatment with one of three immunomodulatory medications (Avonex, Copaxone, or Rebif).

In addition this study will compare the patients' personal view of how they are doing, any changes in physical disability, and the frequency and severity of relapses over the three year period.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of RRMS for at least one year,
* Currently on one of three immunomodulatory drugs (Avonex, Copaxone, or Rebif),
* Visual Acuity is 20/50 or better,
* patient has four color vision,
* Must have at least a high school education

Exclusion Criteria:

* History of head injury, drug/alcohol abuse, and/or psychiatric problems, -current diagnosis of a severe or lifethreatening disease other than MS,
* currently taking immunosuppressant medication,
* resides greater than 200 miles from the study site
Brain Imaging Studies of the Effects of Cocaine Abstinence

This study evaluates theories regarding cocaine abstinence which propose that increased presynaptic and postsynaptic dopamine activity and increased serotonin activity are associated with abstinence in cocaine dependent subjects at the beginning and three to six months after a treatment program. We are using positron emission tomography (PET), Magnetic Resonance Imaging (MRI) and diffusion tensor imaging (DTI) in cortical and subcortical areas in a series of brain imaging studies testing these theories of abnormalities in the dopamine and serotonin system for cocaine addiction by examining the distribution of 18F-fallypride, 18F-altanserin, and FDG. We are evaluating genetic theories associated with cocaine addiction through the examination of genetic markers and functional genomics.


Eligibility Criteria:
Inclusion Criteria:

Inclusion criteria include:

1. Subjects must be male or female and English speaking.
2. Subjects must be adults with a history of diagnosis of cocaine dependence disorder (n=20) who are under supervised treatment for dependence or normal control (n=10).
3. Subjects must be between 21 to 65 years of age.

Exclusion Criteria:

Exclusion criteria include:

1. Suicidality or psychosis.
2. Head injury, kidney or bladder disease or any unstable or serious medical conditions.
3. Prior exposure to radiation (including diagnostic or treatment x-rays), which might cause subjects to exceed standard guidelines.
4. Unwillingness or inability to adhere to the requirements of the study.
5. Donation or large loss of blood (\>400 ml) within the past month.
6. Current or very recent illnesses, painful conditions or other disorders, which in the judgment of the investigators, might invalidate the scientific goals of the study or pose undesirable difficulties or risks for subjects.
7. Pregnancy or breast feeding.
8. Individuals who would be unable to undergo a magnetic resonance imaging (MRI) scan, for example, individuals who suffer from claustrophobia, or who have metal clips in their body, metallic prostheses (i.e., replacement body parts, such as a hip joint), a pacemaker, or other pieces of metal in their body (shrapnel, metal filings, etc.).
Correlation Between Electromyography and Thickness Change of the Trunk Muscles in Subjects With Low Back Pain

Transversus abdominis (TrA) and lumbar multifidus (LM) muscle have been proposed to play key role in stability of the lumbosacral spine. The muscles' functional and/or structural deficits have been linked to the low back pain (LBP) syndrome. Evaluation of the transversus abdominis and lumbar multifidus muscles' function in clinical practice is scarce and not well defined due to number of reasons. Surface electromyography of TrA and LM muscles, as a method of examining muscles function, is not involved in clinical routine. Rehabilitative Ultrasound Imaging (RUSI) of the TrA and LM, apart from providing information about their morphology, could be helpful in assessing their function. Since concentric muscle contraction results in the shortening and thickening of the muscle, evaluation of the potential association between muscle's morphometry, assessed by the ultrasound, and electromyography, may be of potential clinical interest. However, this potential relationship is context-dependant. Our aim was to establish the difference in the thickness change of the TrA and LM muscle during activation in subjects with and without low back pain, and to establish the possible correlation between electromyography and the thickness change of these muscles assessed by ultrasound in both groups of subjects.


Eligibility Criteria:
Inclusion Criteria:

Low back pain, with or without radiculopathy, that lasted for at least 12 weeks, caused by prolapsed intervertebral disc (PID), confirmed by magnetic resonance imaging (MRI)

Exclusion Criteria:

The exclusion criteria for all participants were pregnancy,diabetes mellitus,corticosteroids administrated in one months or less prior to enrollment, spinal fractures, surgery, infectious diseases, tumors, spina bifida, advanced forms of spinal deformity, hip diseases, and neuromuscular disorders. Additional exclusion criteria for LBP participants were self-reported pain levels of less than 3 on the Visual Analog Scale to account for patients commonly encountered in clinical practice, and inability to remain in prone and supine hook-lying positions for 10 minutes each in order to ensure compliance.
Pelvic Neuromuscular Facilitation and Swiss Ball Exercises on Trunk Control in Children With Diaplegic CP

Cerebral palsy is an umbrella term that covers a group of non-progressive motor impairment syndromes that are associated with abnormalities in the brain particularly during the early stages of its development. CP usually involves a number of musculoskeletal and neurological problems they include spasticity, contractures, dystonia, abnormal growth, poor trunk control, and poor balance. Poor trunk control leads to a disturbance in activities of daily living along with postural issues. PNF techniques and Swiss ball exercises target the trunk muscles by stimulating the proprioceptors and by allowing maximum resistance to them respectively. The aim of the study is to do a comparison of Pelvic neuromuscular facilitation techniques and Swiss ball exercises in improving trunk control in children with diplegic cerebral palsy.

The studies conducted in the past were focused on finding out the effect of proprioceptive neuromuscular facilitation techniques on the lower extremities of children suffering from diplegic cerebral palsy. The effects of PNF on trunk control the children suffering from diplegic CP are nearly minimal. In addition to PNF, the literature shows that studies have been conducted to find the effects of Swiss ball training exercise on trunk control of the post-stroke patients however there is very little research on the effects of Swiss ball training in children suffering from diplegic CP. Even if the studies are conducted the time duration of the studies are not enough to gain the maximum outcomes.

Eligibility Criteria:
Inclusion Criteria:

* Patients with no trunk control
* Age between 5-12 years
* Patients with diplegia

Exclusion Criteria:

* Patients with Cognitive impairment
* Patients with comorbidities
* Patients who are unable to follow instructions