cyrilzakka/clinical-trials huggingface dataset:
Effects of Mindfulness Training on Emotion Regulation and Impulsivity

Mindfulness training has proven to be a reliable treatment for patients with Borderline Personality Disorder (BPD).The present randomized-controlled study examines the effects of mindfulness training on emotion regulation and impulsitivy. In addition, fMRI data was collected pre and post intervention. 70 patients with BPD diagnosis were randomized to either mindfulness or interpersonal effectiveness skills training. Assessments were conucted pre-and-post-intervention.


Eligibility Criteria:
Inclusion criteria:

* BPD diagnosis according to two semi -structured interviews: the Structured Clinical Interview for DSM-IV Axis II disorders and the Revised Diagnostic Interview for Borderlines
* Age between 18 and 50 years old
* No comorbidities with schizophrenia, drug induced psychosis, organic brain syndrome, substance dependence, bipolar disorder, mental retardation, or major depressive episode in course
* Not being participating in any other psychotherapy at the moment of the study.

Exclusion criteria:

• Having participated of skills training in the past.
Early Life Nutritional Exposures and Long-term Health and Cognitive Outcomes

This study aims to investigate the relationship of the various exposures during infancy and childhood on later health and development of adolescents. Various exposures to be assessed include, but not limit to, nutritional status, body composition, energy expenditure, dietary intake, micronutrient status, breastfeeding, lifestyle, and other environment exposures.

The study will specifically aim to respond these research questions:

1.1 What are the factors associated with overweight, obesity, and stunted in adolescents? 1.2 What are the factors associated with increased risk of NCDs during adolescence? 1.3 What are the factors associated with cognitive functioning during adolescence? Since numerous variables were collected, additional research questions can be possibly studied or other interested variables can be included in the future.

A longitudinal data were collected in children in the northeast of Thailand beginning at 4-6 months of age and every 2 months through 10-12 months of age while children had been given iron and/or zinc supplementation. Biochemical, anthropometric, socio-demographic, feeding practices, and maternal characteristics data were collected. Children were followed up at 9 years of age to assess the long-term consequences of supplementation and early life nutrition on cognitive functioning and growth. There is a need to continue the follow-up of this study in order to address the association between early nutritional exposures and risks of cardio-metabolic dysfunction and cognitive and behavioral development later in childhood, adolescence and adulthood. Thus, we propose to follow-up these children during adolescence to assess the relationship of early life nutrition and exposures during infancy and childhood and outcomes including nutritional status, cognitive functioning, and risk for non-communicable diseases (NCDs). Findings from this study could provide awareness and information in developing policies and timely interventions to maintain optimal nutritional status throughout vulnerable life stages and reduce risks of NCDs and disabilities later in life.

Eligibility Criteria:
Inclusion Criteria:

* Apparently healthy children

Exclusion Criteria:

* none
Evaluation of Infants With Intrauterine Growth Restriction

Purpose: Clinical assessment (anthropometric) and paraclinical (biochemical and immunological by dosing serum insuline growth factors IGF1 and IGF2 and their receptors) of neonates with intrauterine growth restriction (IUGR) and the integration in a multidimensional statistical model .

Objectives:

1. IGF1 and IGF2 evaluation of serum and IGF1 receptor, IGF2 receptor and IGF2 receptor gene expression in cord blood from newborns with intrauterine growth restriction (IUGR). (Prospective)
2. Evaluation and monitoring of anthropometric, clinical (non-cardiac morbidity) and paraclinical. (Retrospective \& prospective)
3. Evaluation and monitoring of morphological and functional by echocardiography. (Prospective)
4. Integrating multidimensional clinical and paraclinical parameters in a statistical model for evaluating newborn with intrauterine growth restriction.


Eligibility Criteria:
Inclusion Criteria:

* newborns with intrauterine growth restriction (IUGR): weight below the 10th percentile for gestational age
* parental consent for enrollment

Exclusion Criteria:

* IUGR neonates in the context chromosomopathies: trisomy 21, trisomy 18.
* neonates with congenital heart disease
* twins
* refusal of parents for participation to the study
Diagnostic Performances of Urine and Plasma 5-hydroxyindolacetic Acid (5HIAA) Values in Patients With Small-intestine Neuroendocrine Tumors

Urinary measure of 5-hydroxyindolacetic acid (5HIAA) is an important marker for the diagnosis and follow-up of patients with small-intestine neuroendocrine tumors. Although this marker has good specificity, its sensitivity is moderate and its dosage is constraining, since it requires urine collection over 2-3 days and specific diet. Preliminary data suggested that overnight 5HIAA value may be representative of 24-hour 5HIAA value, and that plasma 5HIAA dosage could be a valuable alternative to urine 5HIAA dosage. The main objective of this study is to compare sensitivity and specificity of overnight 5HIAA value, 24-hour 5HIAA value and plasma 5HIAA value, in patients with small-intestine neuroendocrine tumors.

This study primarily aims at comparing the sensitivity and specificity of overnight 5HIAA value, 24-hour 5HIAA value and plasma 5HIAA value, in patients with small-intestine neuroendocrine tumors. Secondary objectives include the correlation of 5HIAA values with chromogranin A, carcinoid syndrome and tumor burden and the evaluation of the compliance to the diet and its correlation with 5HIAA values.

The study group will include patients with proven neuroendocrine tumors of various stages and functioning syndrome profile. A control group will be constituted with subjects having irritable bowel syndrome, in which a neuroendocrine tumor is ruled out. After providing informed consent, patients fitting with inclusion criteria will be included in the study. Patients will have to follow a specific diet, and interrupt/avoid certain medication, during the 2 days before and the 2 days during the sampling period. Whole urine samples will be collected during 2 consecutive days, in 4 parts (day1, night 1, day 2, night 2). Blood samples will be collected at the morning of days 2 and 3. Observance with diet and drug restriction will be evaluated at the morning of day 3.

Eligibility Criteria:
Inclusion criteria:

* Histologically proven small-intestine neuroendocrine tumors, at initial diagnosis or during the follow-up
* Irritable bowel syndrome, diagnosed following Rome III criteria, who had an ileo-colonoscopy and an abdominal CT-scan within the 12 last months
* Age \> 18 years
* No antitumor treatment within the last three months excepted somatostatin analogs
* Ability of understanding and approving the study protocol and of providing written consent
* Affiliation to the French Health Social System

Exclusion criteria

* Small-intestine neuroendocrine tumor in remission (no detectable disease)
* Other malignancies than small-intestine neuroendocrine tumors (excepted if in remission for more than 2 years)
* Kidney insufficiency (MDRD \< 60/min)
* Urinary incontinency or inability to collect urines
* Any antitumor treatment within the last three months excepted somatostatin analogs
* Inability to interrupt treatments interfering with 5HIAA dosage
* Pregnancy
* Patients under law protection
Blepharospasm Short Interval

The objective of this Phase II study is to show that pre-treated patients with BEB with the need of shortened injection intervals achieve an improved and stable quality of life level if they receive repeated NT 201 injections at short injection intervals. In addition, the tolerability of repeated shortened NT 201 administrations in patients with BEB including the development of neutralizing antibodies will be investigated.


Eligibility Criteria:
Inclusion Criteria:

* A clinical diagnosis of bilateral BEB characterized by spontaneous, spasmodic, intermittent or persistent involuntary contractions of the orbicular oculi muscles
* Medical need for treatment with shortened injection intervals (\< 12 weeks) confirmed by the patient and investigator
* Blepharospasm Disability Index (BSDI) at baseline visit before injection of \> / = 1,6

Exclusion Criteria:

* Atypical variant of blepharospasm caused by inhibition of levator palpebrae muscle (apraxia of the eyelid)
* Generalized disorders of muscle activity (e.g. myasthenia gravis, Lambert-Eaton syndrome), as well as amyotrophic lateral sclerosis or any other significant neuromuscular disease which might interfere with the trial
* The previous three injections with Botulinum toxin Type A with more than 50 Units \[U\] per eye per injection session
* Treatment with Botulinum toxins for any indication other than BEB within 4 months prior to baseline and during the trial
Hoosier Sport Re-Social: A Biobehavioral Intervention in Rural Indiana

Hoosier Sport Re-Social is a sport-based intervention designed to increase physical activity (PA) and reduce social media use among children in under-resourced rural areas, aiming to mitigate cardiovascular disease (CVD) risk. The intervention integrates physical activity with social media literacy (SML) training, addressing the dual challenges of low PA levels and high social media usage, which are prevalent in rural communities.

Hoosier Sport Re-Social is a comprehensive, sport-based intervention designed to address the dual challenges of low physical activity (PA) and high social media use among children in under-resourced rural areas. This innovative program aims to reduce cardiovascular disease (CVD) risk by promoting healthier behaviors through the integration of physical activity and social media literacy (SML) training. Recognizing that CVD is a leading cause of death, particularly in under-resourced populations, and that fewer than one in five U.S. children meet the recommended PA levels-especially in rural areas-this intervention targets a significant public health need.

The program is designed to be implemented within the school setting, leveraging both physical education (PE) and health classes to deliver its core components. The PA portion of the intervention takes place during PE classes, where students engage in structured sport activities aimed at increasing daily physical activity levels. This component is designed to enhance students' fitness, build confidence in their physical abilities, and foster a lifelong interest in staying active.

Complementing the physical activity focus, the SML portion is integrated into health classes. Here, students are educated about the impacts of social media on health, particularly its role in influencing behavior and well-being. The curriculum equips students with the knowledge and skills to critically analyze social media content, make informed decisions about their digital consumption, and develop healthier online habits.

Eligibility Criteria:
Inclusion Criteria:

* enrolled in 7th-9th grade
* provides parental consent
* provides assent

Exclusion Criteria:

- Inability to attend school regularly during the 6-week intervention period
Magnetic Resonance Cholangio-pancreatography (MRCP) for Suspected Bilio-pancreatic Disease

The interpretation of Magnetic Resonance Cholangio-pancreatography (MRCP)-findings is primarily performed by radiologists who only in some cases have experience with the interpretation of endoscopic retrograde cholangiopancreatography (ERCP)-images. It is unclear if MRCP-interpretation by the radiologist is sufficient to decide which additional endoscopic procedures might be necessary in an individual case or if an additional MRCP-interpretation by the endoscopist renders any clinical impact.


Eligibility Criteria:
Inclusion Criteria:

* Patients aged 18 years or older who were referred for pancreato-biliary endoscopy to our unit based on actual MRCP-findings. In all cases MRCP should have been performed within 4 weeks prior admittance and a written radiological report as well as the digital images must be available.

Exclusion Criteria:

* Patients who had any endoscopic interventions in our institution before and also patients who underwent MRCP at our hospital were excluded.
Efficacy and Safety of Dexmedetomidine Added to Modified Pectoral's Block

The Pecs block (pectoral nerves block) is an easy and reliable superficial block inspired by the infraclavicular block approach and the intercostal abdominis plane blocks . Many additives were used in combination with local anesthetics in Pecs block to prolong the postoperative analgesia (fentanyl, dexmedetomidine).

60 patients scheduled for modified radical mastectomy surgery under general anesthesia. Group I (Bupivacaine group): patients underwent modified radical mastectomy were given preoperative ultrasound guided modified Pecs block with 30 mL of 0.25% bupivacaine divided into 10 ml injected between the pectoralis muscles on the interfascial plane, and 20 ml injected between the Pectoralis minor muscle and the serratus muscle.Group II (Bupivacaine + Dexmedetomidine group) : preoperative ultrasound guided modified Pecs block with 30 mL of 0.25% bupivacaine plus Dexmedetomidine (1 µg/kg) divided into 20 ml injected between the pectoralis muscles on the interfascial plane , and 10 ml injected between the Pectoralis minor muscle and the serratus muscle.

Eligibility Criteria:
Inclusion Criteria:

* ASA I - II patients

  * weight 50- 100 kg
* age 18-60 years

Exclusion Criteria:

* History of bleeding diathesis
* Relevant drug allergy
* Opioid dependence
* Sepsis
* Those with psychiatric illnesses that would interfere with perception and assessment of pain will be excluded from the study
Evaluation of Non-Invasive Continuous vs Intermittent BloodPressure Monitors in Maintenance Dialysis (BP Dialysis)

Prospective, single center, open label, non-randomized, post-market study of the Tablo Hemodialysis System and VitalStream Monitor in participants with End-Stage KidneyDisease undergoing In-Center Hemodialysis.


Eligibility Criteria:
Inclusion Criteria:

* Participant is at least 18 years of age and has provided informed consent and has signed a Health Insurance Portability and Accountability Act of 1996 (HIPAA) compliant authorization statement.
* Participant weighs ≥ 34kg.
* Participant has end stage kidney disease (ESKD) adequately treated by maintenance dialysis.

Exclusion Criteria:

* Participant has lack of perfusion of the digitalarteries and arterioles in the lower arm and hand.
* The Non-Invasive Blood Pressure (NIPB) monitorcuffs (finger and/or brachial) are unable to becorrectly sized to the participant.
Identification of Clostridium Butyricum and Clostridium Neonatal in the Digestive Microbiota of Premature Infants Before 34 Weeks and Developing or Not Ulcerative Necrotizing Enterocolitis (NEC) During Hospitalization

The study investigators hypothesize that Clostridium butyricum and Clostridium neonatal will be more frequently found in the stool of preterm infants with ulcerative necrotizing enterocolitis compared to healthy matched control infants. Systematic daily samples should show that the kinetics of colonization precedes the onset of the pathology. Finally, the systematic ecological survey at the time of infection could help understand the mode of acquisition and transmission of these bacteria.


Eligibility Criteria:
Inclusion Criteria:

* Premature newborn with a term of birth ≤ 34 weeks of gestation admitted to the neonatology department at the CHU of Nîmes.
* Affiliated or beneficiary of a health insurance plan.
* Newborn whose parents received informed information about the study and did not express their opposition to their child's participation in the study.

Exclusion Criteria:

* Newborn with malformative digestive pathology
* Newborn baby participating in another category 1 trial
Effect of Malnutrition on Primary and Permanent Dentation

The caries index delayed eruption and enamel malformation will recorded for a 2 group of participants

The participants suffering from malnutrition will be divided into age group from 4 to 6 to study the primary dentition and another group age from 13 to 16to study the primary dentition caries index with dmf and DMF score Modified DDE index for measurement of developmental defects in enamel

Eligibility Criteria:
Inclusion Criteria:

* parent accept to sign the informed consent Participants not suffering from any other systematic disease

Exclusion Criteria:

* non coopreative patient Suffering from systematic disease
Effect of Reparel Knee Sleeve with Knee Injection

The goals of treating knee osteoarthritis (OA) is to improve or maintain quality of life, mobility and function, pain relief, and improve inflammation. The different treatment options for knee OA have been extensively studied and implemented, but the optimum treatment is still undecided. There is a belief that anti-inflammatory sleeve technology may be beneficial in treating knee OA. The purpose of this study is to determine if the Reparel™ knee sleeve results in superior mobility, functionality, and pain outcomes as compared to a placebo knee sleeve in managing knee OA.

Patients who are recommended non-operative management of their knee osteoarthritis and have consented to participate in the study will be randomized into two groups to receive either of the following

1. Reparel knee sleeve
2. Placebo knee sleeve

Participants assigned to both groups will be given instructions on how to use/wear the sleeve while performing activities of daily living or sports that had previously resulted in knee pain and also be asked to do the follows:

* Wear the sleeve as much as they possibly can
* Not change their usual activities and diet during the time they are on this study.
* Record in a diary the number of hours sleeve was worn per day
* Record any adverse effects or discomfort due to sleeve use.
* Not to receive any injections in the subsequent 6 months following baseline randomization visit.

Participant background information that is relevant to this study will also be collected from their medical record including age, sex, and race and stored in a hospital secure computer database (REDCap).

Participants will also be asked to complete the Knee Injury and Osteoarthritis Outcome Score (KOOS), Single Assessment Numeric Evaluation (SANE), Oxford Knee Score (OKS), Lysholm Score, UCLA Activity Score and Visual Analog Scale (VAS) survey questionnaires at baseline randomization visit (T0), at 4 weeks (T1), at 3 months (T2), and at 6 months (T3) to assess the mobility, functionality, and pain associated with the affected leg.

The responses to the surveys will be recorded on a password-protected laptop and all patient identifiers will be replaced with unique identifier numbers. Only the study team will have access to the responses from the forms. The analysis of de-identified data will be done through SPSS 27, and scores for the questionnaires will be averaged and compared between the two groups.

Eligibility Criteria:
Inclusion Criteria:

* osteoarthritis visible on knee radiograph
* patient opting for non-surgical treatment

Exclusion Criteria:

* bilateral symptomatic knee osteoarthritis
* prior surgery on the knee of interest
* hardware present on the knee of interest
* gross instability detected on physical exam
* malignancy in the knee of question
Ruxolitinib for the Treatment of Chronic Myelomonocytic Leukemia (CMML): A Phase 2 Expansion

This study is to find out if treating Chronic Myelomonocytic Leukemia (CMML) with a study drug (ruxolitinib) can improve outcomes of patients with CMML.


Eligibility Criteria:
Inclusion Criteria:

* Confirmed diagnosis of Chronic Myelomonocytic Leukemia (CMML)using the World Health Organization (WHO) classification.
* 18 years of age or older at the time of obtaining informed consent.
* Must be able to adhere to the study visit schedule and other protocol requirements.
* Participants must be able to provide adequate BM aspirate and biopsy specimens for histopathological analysis and standard cytogenetic analysis during the screening procedure.
* An Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1, or 2 is required.
* Women of childbearing potential must agree to use two reliable forms of contraception simultaneously or to practice complete abstinence from heterosexual intercourse 1) for at least 28 days before starting study drug; 2) while participating in the study; and 3) for at least 28 days after discontinuation from the study.
* Must understand and voluntarily sign an informed consent form.
* Must have a life expectancy of greater than 3 months at time of screening.
* Must have symptomatic splenomegaly and/or an Myeloproliferative Neoplasms Symptom Assessment Form Total Symptom Score \>17.

Exclusion Criteria:

* Any of the following lab abnormalities: Platelet count of less than 35,000/uL, Absolute Neutrophil Count (ANC) less than 250/uL, Serum Creatinine ≥ 2.0, Serum total bilirubin \>1.5x ULN
* Use of cytotoxic chemotherapeutic agents, or experimental agents (agents that are not commercially available) for the treatment of CMML within 28 days of the first day of study drug treatment.
* Prior history of metastatic malignancy in past 2 years
* Any serious medical condition or psychiatric illness that will prevent the subject from signing the informed consent form or will place the subject at unacceptable risk if he/she participates in the study.
* Concurrent use of Granulocyte-Macrophage Colony Stimulating Factor (GM-CSF). Granulocyte Colony Stimulating Factor (G-CSF) could be used for the short-term management of neutropenic infection. Stable doses of erythropoietin stimulating agents that were started \>8 weeks from first ruxolitinib dose or corticosteroids that were being administered prior to screening are allowed.
* Uncontrolled current illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
* Pregnant women are excluded from this study because ruxolitinib has not been studied in pregnant participants. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with ruxolitinib, breastfeeding should be discontinued if the mother is treated with ruxolitinib.