cyrilzakka/clinical-trials huggingface dataset:
Effect of Tele-consultation in Addition With Psychiatric Follow-up During COVID-19 in Women Who Have Medical History of Post-partum Depression

Women who were able to benefit from psychiatric follow-up during the quarantine by tele-consultation have a lower risk of anxious and depressive symptoms than those who did not receive follow-up.

The pandemic of COVID-19 (coronavirus desease 19) led to a strict quarantine from 15 March 2020 to 11 May 2020. Maternal depression is a current pathology , especially in the post-partum (more than 15%). The quarantine could lead to anxious and/or depressive symptoms and difficulties in parents-children bonding.

Women who have experenced post-partum period have more chance to developp subsequent depression.

Among women who have experienced post-partum depression, those who were able to benefit from psychiatric follow-up during the quarantine by tele-consultation have a lower risk of anxious and depressive symptoms than those who did not receive follow-up.

Eligibility Criteria:
Inclusion Criteria:

Women above 18 years old

Who have experienced a post-partum depression between 2013 and late of 2019

Who have benefit a psychiatry post-partum follow-up (hospitalizations in psychiatry post-partum unity and/or medical consultation) by Bicêtre psychiatry service

Who have a child less than 7 years old (preschool age)

Speaking and reading in french

And their partner (above 18 years old)

In the main analyze, only women with a indication of following psychiatric follow-up by tele-consultation (with a psychiatric follow-up at the begenning of the quarantine, who have not been follow-up by psychiatrist in hospitalization or in face to face consultation) will be analyzed

Exclusion Criteria:

People with chronic psychotic disorder (Diagnostic and Statistical Manual of Mental Disorders:DSM-5 criteria)

People with mental handicap

People who are not able to give their consent

People subject to protection measure

People refusing to participate in the study
Epoprostenol for Injection in Pulmonary Arterial Hypertension - Extension of AC-066A401

This is an open-label, non-randomized extension to study AC-066A401. The study will assess safety and tolerability of ACT-385781A and Flolan (epoprostenol sodium) while providing a means for continuing treatment after ending participation in study AC-0066A401.


Eligibility Criteria:
Inclusion Criteria:

1. Signed informed consent prior to initiation of any study-mandated procedure
2. Patients who completed participation in study AC-066A401
3. Patients who have not obtained authorization for commercial ACT-385781 and Flolan at the time of ending participation in study AC-066A401

Exclusion Criteria:

1. Patients who prematurely discontinued study drug in study AC-066A401
2. Patients for whom continued treatment with either ACT-385781 and Flolan is no longer considered appropriate
3. Known hypersensitivity to the investigational drug or comparative drug or drugs of the same class, or any of their excipients
4. Any known factor or disease that might interfere with treatment compliance, study conduct or interpretation of the results such as drug or alcohol dependence or psychiatric disease
5. Known concomitant life-threatening disease with a life expectancy \< 12 months
Double-blind Extension of HORIZON Pivotal Fracture Trial (Zoledronic Acid in the Treatment of Postmenopausal Osteoporosis)

This extension study is designed to assess the long term safety and efficacy of zoledronic acid in postmenopausal women with osteoporosis who have participated in the CZOL446H2301 (NCT00049829): HORIZON Pivotal Fracture Trial. This extension study began after the 3-year core study ended. Baseline is the same as Year 3.


Eligibility Criteria:
Inclusion Criteria:

* Patients who have received 3 infusions in the HORIZON-Pivotal Fracture (PFT) Study.

Exclusion Criteria:

* Poor kidney, eye, or liver health
* Use of certain therapies for osteoporosis in the HORIZON-PFT study (other than the study medication)
* Abnormal calcium levels in the blood

Other protocol-defined inclusion/exclusion criteria may apply.
Comparison of the Short-Term Effect of Dietary Carbohydrate Restriction Versus Exogenous Ketone Supplementation on Myocardial Glucose Suppression and Timing to Achieve a State of Ketosis Using FDG PET/CT Serial Imaging

The purpose of this study is to test different methods of preparation that can be used prior to a test called an FDG PET/CT scan. FDG PET/CT scans are routinely done for evaluation of heart inflammation. Standard preparation for the scan includes a ketogenic (high fat and low carbohydrate) diet for 24 hours and overnight fasting to help suppress the amount of sugar taken up in the heart muscle. However, Investigator still do not know if this preparation is the most effective method. So the Investigator, want to investigate alternative methods for decreasing the amount of sugar uptake seen in the heart during FDG PET/CT scan, thus, investigator will have participants try up to 3 different methods of preparation prior to the FDG PET/CT scans to see which type of preparation works the best.


Eligibility Criteria:
Inclusion Criteria:

1. Adult patients, at least 18 years of age
2. No history of cardiovascular disease, including hypertension, hyperlipidemia, coronary artery disease, cardiac surgery, arrhythmias per medical record review and/or self-report
3. No history of diabetes mellitus, chronic liver or kidney disease per medical record review and/or self-report.
4. Participants must be informed of the investigational nature of this study and provide written informed consent in accordance with institutional and federal guidelines prior to study-specific procedures.

Exclusion Criteria:

1. Females who are pregnant or breast-feeding at the time of screening will not be eligible for this study. Female participants of child-bearing potential will have a urine or serum pregnancy test before the first study visit.
2. Inability to tolerate imaging procedures in the opinion of the investigator or treating physician.
3. Serious or unstable medical or psychological conditions that, in the opinion of the investigator would compromise the subject's safety or successful participation in the study.
Quantitative Muscle Ultrasound as a Marker of Progression in Children With Muscular Diseases

The aim of our study is to Assess skeletal muscle structural status in children with inflammatory myositis and Duchenne muscular dystrophy using musculoskeletal ultrasound and to perform a longitudinal follow up of these changes over 2 years and to assess the relation between these findings with clinical parameters, functional scales, biochemical and electromyographic tests.

This study will be carried out on two groups:

• Group (I): fifty children diagnosed to have duchenne muscular dystrophy and inflammatory myositis.

Group (II): including 20 healthy children matching age and sex as control group.

patients will be subjected to

(A) Clinical evaluation

1. Complete history taking.
2. Thorough clinical examination.
3. Body mass index (BMI) assessment.
4. Quantitative muscle strength tests
5. Functional grading
6. Childhood Myositis Assessment Scale. 7 (B) Laboratory assessment:

All patients will be subjected to the following measurements:

1. Serum creatine kinase levels (CK).
2. Serum Lactate dehydrogenase levels
3. Serum of Liver enzymes (SGOT\& SGPT) levels.

(C) Electromyographic (EMG) assessment:

(D) Musculoskeletal ultrasound assessment (E) Statistical analysis

Eligibility Criteria:
Inclusion Criteria:

* children with Duchenne muscular dystrophy (DMD). Diagnosis with DMD was established according to DMD diagnostic criteria (Jennekens et al., 1991).
* children with juvenile dermatomyositis (JDM) according to Bohan and Peter diagnostic criteria ( (Bohan and Peter, 1975).

Exclusion Criteria:

* Patients with age less than 2 years were excluded from the study due to inability to perform manual muscle testing and functional scales.
* If no final diagnosis could be established.
* The presence of a concomitant illness that may result in peripheral neuropathy or myopathy.
Study to Determine Pediatric Bladder Volume Prior to Catheterization

This is a randomized controlled trial evaluating the effectiveness of bedside volumetric bladder ultrasound prior to transurethral catheterization of pediatric patients presenting to an emergency department with suspected urinary tract infection.

Ultrasound prior to catheterization allows Emergency Physicians to determine if the urine volume of the bladder is sufficient for successful catheterization. Advance knowledge of insufficient urine allows the Emergency Physician to defer the procedure until success is likely.


Eligibility Criteria:
Inclusion Criteria:

* Children 0-36 months of age
* Require urethral catheterization for urine analysis

Exclusion Criteria:

* Recently voided and unlikely to provide sufficient urine when catheterized
* Documented or suspected genitourinary abnormalities precluding urethral catheterization
* Indwelling catheter or urostomy
* Critical illness
* No available legal guardian or legal guardian does not understand English well enough to provide informed consent
* Technical failure of the utlrasound equipment
Smart Phone for Stroke Upper Limb Motor Function Training

Stroke rehabilitation for stroke patients can enhance the upper and lower limb function, daily of daily activity improvement, and be beneficial to the family members' quality of life. Literature studies have supported the use of tele-rehabilitation to be as effective as stroke home rehabilitation. Stroke tele-rehabilitation model can use smartphones and apps to practice the mobile health model. Nevertheless, effects of tele-rehabilitation analysis for the proximal recovery of the stroke upper limbs still need to be explored. The main purpose of this research is to develop a smart phone with app system for stroke upper limb motor training, and further analyze its feasibility and treatment effects. The investigators randomly assigned chronic home stroke cases to the experimental group (n=20) and control group (n=20), each group received 8 weeks of treatment.

Stroke rehabilitation (including occupational therapy and physical therapy) for stroke patients can enhance the upper and lower limb function, daily of daily activity improvement, and be beneficial to the family members' quality of life. Literature studies have supported the use of tele-rehabilitation to be as effective as stroke home rehabilitation. Stroke tele-rehabilitation model can use smartphones and apps to practice the mobile health model. This technology with remote rehabilitation have the important characteristics, including ease of use, high-intensity, repetitive exercises, and providing feedback information, to facilitate the recovery of training functions. Nevertheless, effects of tele-rehabilitation analysis for the proximal recovery of the stroke upper limbs still need to be explored. The main purpose of this research is to develop a smart phone with app system for stroke upper limb motor training, and further analyze its feasibility and treatment effects. The investigators randomly assigned chronic home stroke cases to the experimental group (n=20) and control group (n=20), each group received 8 weeks of treatment.

Eligibility Criteria:
Inclusion Criteria:

* First onset
* Unilateral Hemiplegia
* No obvious cognitive impairment (Mini-Mental State Examination (MMSE) score \> 23)
* The FMA upper limb movement score is above 30 points
* Those who have used a smartphone for more than 3 months before the onset of the disease or at present
* Those who have no obvious vision loss and can read the text on mobile phones clearly
* Those who own a smart phone

Exclusion Criteria:

* Language barriers or aphasia
* Other orthopedic diseases (such as severe shoulder pain, joint contractures) or nerve damage (such as peripheral nerve damage) that affect the movement of the upper limbs
* Feel severe Absence, FMA sensory score \<12 points
* Other progressive diseases such as cancer, amyotrophic lateral sclerosis, multiple sclerosis, etc
A Study of Vortioxetine (Lu AA21004) in Comparison to Agomelatine in Adults Suffering From Major Depression With Inadequate Response to Previous Medication

The objective of the present study is to evaluate whether vortioxetine (10 or 20 mg/day) is at least as effective as agomelatine (25 to 50 mg/day) in patients with depressive symptoms that showed inadequate response to Serotonin Reuptake Inhibitors (SRI) antidepressants.


Eligibility Criteria:
Inclusion Criteria:

* The patient is being treated with a serotonin reuptake inhibitor (SRI) antidepressant (monotherapy) that was prescribed to treat Major Depressive Episode (DSM-IV-TR criteria)
* The response to the current SRI treatment is inadequate and patient agrees to discontinue the current SRI at the baseline
* Montgomery Åsberg Depression Rating Scale (MADRS) total score ≥22 at the Screening Visit and Baseline
* The patient, if a woman, must: agree not to try to become pregnant during the study, AND use adequate, highly effective contraception

Exclusion Criteria:

* The patient has any current Axis I disorders (DSM-IV criteria) other than Major Depressive Disorder (MDD), General Anxiety Disorder (GAD) and Social Anxiety Disorder (SAD)
* The patient is at significant risk of suicide
* The patient is currently receiving formal psychotherapy or other psychoactive medications

Other protocol-defined inclusion and exclusion criteria may apply.
P-PSMA-101 CAR-T Cells in the Treatment of Subjects With Metastatic Castration-Resistant Prostate Cancer (mCRPC) and Advanced Salivary Gland Cancers (SGC)

An open-label, multi-center, single and cyclic ascending dose study of P-PSMA-101 autologous CAR-T cells in patients with mCRPC and SGC.

This is an open label, multi-center Phase 1 study that will follow a 3 + 3 design of dose-escalating cohorts of single and multiple doses of P-PSMA-101 to determine a Recommended Phase 2 Dose (RP2D). Additional participants will be treated with P-PSMA-101 at the determined RP2D.

Following consent, enrolled participants will undergo a leukapheresis procedure to obtain peripheral blood mononuclear cells (PBMCs) which will be sent to a manufacturing site to produce P-PSMA-101 CAR-T cells. The cells will then be returned to the investigational site and administered after a lymphodepleting chemotherapy regimen. Rimiducid may be administered as indicated.

Eligibility Criteria:
Inclusion Criteria:

* Subjects ≥18 years of age
* Must have a confirmed diagnosis of mCRPC or SGC
* Must have measurable disease by RECIST 1.1 or bone only metastases with measurable PSA (≥1 ng/mL) (mCRPC subjects only)
* Must have progressed by PCWG3 and/or RECIST 1.1 (mCRPC subjects only)
* Must be willing to practice birth control from screening and for 2 years after the last administration of P-PSMA-101
* Must have adequate vital organ function within pre-determined parameters
* Must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1

Exclusion Criteria:

* Has inadequate venous access and/or contraindications to leukapheresis
* Has an active second malignancy in addition to mCRPC or SGC, excluding low-risk neoplasms such as non-metastatic basal cell or squamous cell skin carcinoma
* Has a history of or active autoimmune disease
* Has a history of significant central nervous system (CNS) disease, such as stroke or epilepsy
* Has an active systemic (viral, bacterial or fungal) infection
* Has received anti-cancer medications (excluding GnRH targeted therapies) within 2 weeks of the time of initiating conditioning chemotherapy
* Has received immunosuppressive medications (including anti-cancer medications) within 2 weeks of initiating leukapheresis and/or expected to require them while enrolled in the study
* Has received systemic corticosteroid therapy within 2 weeks of either the required leukapheresis or is expected to require it during the course of the study
* Has CNS metastases or symptomatic CNS involvement
* Has a history of significant ocular disease
* Has a history of significant liver disease or active liver disease
* Has liver metastases (\<5 lesions and maximum diameter \</= 2.5 cm permitted)
* Has a history of or known predisposition to HLH or MAS
Impact of Mortality Salience on Treatment Decisions

The goal of this clinical trial is to learn if mortality salience has an impact on treatment decisions in urologists and patients with urological cancer. The main questions it aims to answer are:

Does mortality salience lead to more aggressive treatment decisions in a) urologists and b) patients with urological cancer? Which factors predict more aggressive treatment decisions a) in urologists and b) in patients with urological cancer? Is the Fear of cancer recurrence-1 (FCR-1) in German language a valid screening tool for fear of cancer progression in patients with urological cancer?

Researchers will compare a mortality salience trigger to control questions to see if mortality salience leads to more aggressive treatment decisions.

Participants will:

Answer the Mortality Attitudes Personality survey (MAPS) to trigger mortality salience and, in three borderline case vignettes, provide information on how likely they would be to choose a more aggressive therapy.

Background: Harmful overtreatment is a major problem in oncology. Unconscious fear of death (mortality salience) could increase the likelihood of a physician or patient decision in favor of aggressive therapy and thus contribute to overtreatment.

Methods: Conduction of two randomized controlled trials: 1. online survey of n = 260 urological patients, 2. paper questionnaire survey of n = 260 urological cancer inpatients. Intervention group: triggering of mortality salience with two open questions on death, control group: two open questions on dental treatment. The primary endpoint is the probability of opting for aggressive treatment in three questions on a treatment decision Likert scale from 0 to 10). In both studies, the evaluation is carried out as a comparison of means using a two-sided t-test. Secondary endpoints are further factors associated with a decision in favor of aggressive therapy.

Result: An increase in the probability of a decision in favor of the more aggressive therapy as a result of triggering mortality salience is expected with an effect size of d = .35.

Discussion: In order to avoid harmful overtreatment due to unconscious fear of death, doctors could undergo training to deal with their existential fears - this could take place as part of communication training. For cancer patients, this confrontation can take place as part of psycho-oncology training.

Eligibility Criteria:
Study 1) Urologists

Inclusion Criteria:

* sufficient cognitive ability
* German language skills

Exclusion Criteria:

* none

Study 2) Patients

Inclusion Criteria:

* urological cancer (ICD-10: C60, C61, C62, C63, C64, C65, C66, C67, C68)
* age at least 18 years
* German language skills
* sufficient cognitive ability
* capacity to consent

Exclusion Criteria:

* none
Labelled Carbon Sucrose Breath Test (13C-SBT) as a Marker of Environmental Enteropathy

Linear growth failure, a manifestation of chronic undernutrition in early childhood, is a recalcitrant problem in resource constrained settings. The underlying causes of growth failure are multifactorial, but persistent and recurrent infection and inflammation of the gastrointestinal tract and immune activation, a condition commonly referred to as environmental enteropathy, is an important contributor. A highly enriched 13C-Sucrose Breath Test, a measure of sucrase-isomaltase activity, will be evaluated as a non-invasive biomarker of environmental enteropathy, and more specifically of intestinal brush border enzyme activity in 6 resource poor countries (Bangladesh, India, Jamaica, Kenya, Peru and Zambia) in 100 volunteers aged 12-15 months (total n=600) and evaluated relative to the lactose rhamnose test and linear and ponderal growth over a 3-6 month period following biomarker assessment. Field usability will also be assessed.

Environmental enteropathy is associated with linear and ponderal growth shortfalls in young children in resource constrained settings. However, the physiological alterations of intestinal function that accompany both the demonstrable evidence of inflammation and architectural changes seen in biopsies from effected children have yet to be elucidated, and this knowledge gap limits the development of effective strategies to optimally manage the condition. Furthermore, a limited number of non-invasive assays exist with which to assess the presence of environmental enteropathy in low resource settings. This study aims 1) to determine if sucrose-isomaltase enzyme is altered in children with environmental enteropathy by using a 13C-Sucrose breath test 2) to determine if the test is able to be employed in resource limited settings.

Eligibility Criteria:
Inclusion Criteria:

All children will be recruited and enrolled through convenience sampling, either at the community level (if the study site has previously censused the community) or through child clinic visits.

Exclusion Criteria:

1. Severe acute malnutrition
2. HIV positive
3. Weight for height Z \>+2
4. Known medical illness contributing to growth failure
Handwriting Analysis in Movement Disorders

Handwriting is a complex cognitive prowess that deteriorates in patients affected by neurodegenerative diseases, including movement disorders. More in detail, patients with Parkinson's disease (PD) may manifest prominent handwriting abnormalities which have been collectively identified as parkinsonian micrographia. MIcrographia may manifest at the onset of the disease and then worsens progressively with time. Previous techniques released to investigate micrographia in PD relied on perceptual analysis of simple tasks or were based on expensive technological tools, including tablets. However, handwriting can be promptly collected in an ecological scenario, through safe, cheap, and largely available tools. Also, the objective handwriting analysis through artificial intelligence would represent an innovative strategy even superior to previous techniques, since it allows for the analysis of large amounts of data. In this experimental project, the investigators apply a specific machine learning algorithm to analyze handwriting samples recorded in healthy controls and PD patients. The study aims to verify whether the technique proposed by the investigators would be able to detect parkinsonian micrographia objectively, monitor the evolution of handwriting abnormalities and assess the symptomatic improvement of handwriting following L-Dopa administration in PD patients.


Eligibility Criteria:
Inclusion Criteria:

* Healthy conditions
* clinical diagnosis of Parkinson's disease

Exclusion Criteria:

* cognitive decline
The Effect of Pain Neuroscience Education on Patients With Arthroscopic Rotator Cuff Repair

During the rehabilitation process after rotator cuff repair surgery, patients suffer from increased pain and discomfort due to dysfunction. Pain neuroscience education, a more modern educational method, has been reported to be effective in controlling pain by reducing the fear of movement based on an understanding of neurophysiology.


Eligibility Criteria:
Inclusion Criteria:

* Adults over 18 years old
* In case of 4 weeks after receiving arthroscopic rotator cuff repair
* If you wish to participate in research

Exclusion Criteria:

* 65 years old or older
* Those who are limited in conducting education remotely
* If the tear area is large and augmentation is performed
* If there is a previous surgical history at the surgical site
* Osteoarthritis in the shoulder joint
* If you cannot understand the guidelines for evaluation or intervention
* Mental health and cognitive problems