cyrilzakka/clinical-trials huggingface dataset:
Randomized Clinical Trial to Improve Mobility After Hospitalization

The objective of this study is to test the feasibility of using behavioral economic interventions (gamification with social incentives) to increase physical activity after hospital discharge to reduce incident mobility disability among older adults.

MOVE ON is a 2-arm, randomized trial enrolling older adults 50 years or older with a recent hospitalization for hypertension, diabetes, and mild-moderate heart failure. The 52 week trial compares a control group wearing a wearable activity tracker to the intervention group that uses the same device and receives a supportive social incentive-based gamification intervention. The primary goal is to increase physical activity after discharge from the hospital to reduce incident mobility disability associated with acute illness and to reduce acute and post-acute care utilization.

Eligibility Criteria:
Inclusion Criteria:

* Age 50 years or older
* Admitted to the University of Pennsylvania Health System acute care hospital (Hospital of the University of Pennsylvania, Penn Presbyterian Medical Center, Pennsylvania Hospital, Lancaster General Health, Chester County Hospital, or Penn Medicine Princeton Medical Center) and discharged to home
* Able to ambulate independently

Exclusion Criteria:

* Inability to provide informed consent
* Does not have daily access to a smartphone compatible with the wearable device and is not willing to use a device that the investigators can provide participants' with
* Already enrolled in another physical activity study
* Low mobility score indicating that the patient is not able to walk distances greater than 1000 steps/day independently
* Any other medical conditions that would prohibit participation in a 6-month physical activity program
* Unable to complete the baseline period (must have at least 4 out of 7 days of step data with minimum step count of 1000 steps/day)
* Not willing to use the wearable device for the full duration of the study
* Enrolled in hospice
Response or Resistance to Chemotherapy in Young Patients With Acute Lymphoblastic Leukemia Treated With Methotrexate

This laboratory study is looking at response or resistance to chemotherapy in young patients with acute lymphoblastic leukemia treated with methotrexate. Studying samples of tumor tissue in the laboratory from patients with cancer may help doctors learn more about changes that occur in DNA and drug resistance in patients.

OBJECTIVES:

I. Determine the molecular basis for human reduced folate carrier (hRFC) transcripts in B-precursor and T-cell acute lymphoblastic leukemia (ALL) blasts obtained from children with newly diagnosed ALL subsequently treated with methotrexate.

II. Correlate hRFC expression in these specimens with methotrexate transport and sensitivities.

III. Determine the roles of high frequency gene/transcript variants for hRFC as determinants of response and resistance to methotrexate in these patients.

IV. Determine the roles of multidrug resistance-associated proteins as determinants of response and resistance to methotrexate and mercaptopurine in these patients.

OUTLINE: This is a multicenter study.

Tumor diagnostic specimens from patients who subsequently failed therapy within 4 years of diagnosis or who did not fail therapy within 4 years of diagnosis (control patients) are obtained from the Children's Oncology Group cellbank. Specimens are studied for molecular determinants of human reduced folate carrier (hRFC) gene expression and gene sequence alterations using reverse transcriptase-polymerase chain reaction (RT-PCR), thymidylate synthase inhibition assay, Rnase protection assay, or 5'RACE. Multidrug resistance proteins are also studied by RT-PCR.

A certificate of confidentiality protecting the identity of research participants in this project has been issued by the National Cancer Institute.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of B-precursor or T-cell acute lymphoblastic leukemia

  * Newly diagnosed disease subsequently treated with methotrexate
* Banked diagnostic blast specimens are available from Childrens Oncology Group (COG) cellbank
Does Pregabalin Improve Post-operative Pain After C-section Delivery

Pregabalin due to its antihyperalgesic effect, has proven its efficacy on neuropathic pain, essentially in nociceptive surgeries. Few studies have attempted to identify the utility of pregabalin as a premedication before cesarean delivery.

The investigators aimed to determine whether or not pregabalin as premedication improves analgesia post cesarean delivery.

The investigators conducted a controlled, randomised, prospective and double-blind trial. One hundred thirty eight participants were included, with American Society of Anesthesiologists physical status classification of I to II, with pregnancies of at least 36 weeks of gestation who were scheduled for elective caesarean delivery under spinal anaesthesia. One hour before induction of anaesthesia participants received a capsule containing sugar placebo (placebo group), pregabalin 150 mg or pregabalin 300 mg. Data related to surgical history, pre-existing medical problems, indications for cesarean and peroperative hemodynamic changes were analyzed. The primary outcome was first analgesic request. Secondary outcomes included maternal pain scores at rest and during movement, rescue analgesics consumption, sedation, nausea, vomiting, pruritus and Apgar scores. All maternal secondary outcome variables were recorded 0, 2, 4, 6, 12, 18, and 24 h after delivery. Common side effects linked to pregabalin such as somnolence, blurred or abnormal vision, or fetal distress were collected.

Eligibility Criteria:
Inclusion Criteria:

* American Society of Anesthesiologists class I or II
* single pregnancies at term
* under spinal anesthesia

Exclusion Criteria:

* conversion to general anesthesia
* post partum hemorrhage requiring specific resuscitation
* local anesthetic toxicity
* violation of the protocol
Observational Study Evaluating the Management of Chronic Coronary Occlusions In France

Data from the literature on the management of Chronic Coronary Occlusions (CTO) in France highlight a lack of epidemiological data on these patients at the national level.

For this reason, it was decided to set up this large-scale survey in order to have a picture of the management of patients with chronic coronary occlusion in France, to study the prevalence of CTOs in France as well as their management (medical, surgical or interventional), and then by analysing more precisely, over a second survey period, CTO angioplasties in terms of success rates, complications, medico-economic impact.

This exhaustive and descriptive study of CTO patients, performed on a set of approximately 100 interventional cardiology centers in France, will be conducted in two steps:

* 1st step: This collection will be done over one month, the objective of which will be to photograph the therapeutic choice in the management of CTO (drug, surgical, endovascular approach).
* 2nd step: a second collection will be carried out over a period of two months, the objective of which will be to evaluate, in patients presenting a CTO with an attempt at angioplasty, the success of the procedure.

Eligibility Criteria:
Phase I

Inclusion Criteria:

* Patient over 18 years old
* Patient with CTO

Exclusion Criteria:

* Patient with acute occlusion or subocclusive lesion or CTO of less than 3 months
* Patient expressing his refusal to participate in the observatory

Phase II

Inclusion Criteria:

* Patient over 18 years old
* Patient with CTO who has attempted angioplasty

Exclusion Criteria:

* Patient with acute occlusion or less than 3 months.
* Patient demonstrating refusal to participate in the observatory
Exercise Capacity in Bronchiectasis Resection

Bronchiectasis can be defined as an abnormal and irreversible dilatation of the bronchial tree due to repeated cycles of inflammation and infection, resulting in progressive loss of lung function. The surgical treatment by pulmonary resection or even lung transplantation is indicated in cases of bronchiectasis primary nonresponsive to appropriate medical treatment, or when associated with serious complications. There are few literature data on the influence of bronchiectasis in exercise capacity, quality of life and functional capacity, and the impact of lung resection in patients with this diagnosis. The primary objective of this study is to evaluate prospectively the impact of lung resection on exercise capacity in patients with clinical and radiological diagnosis of bronchiectasis. The secondary objective of this study is to evaluate the impact of lung resection on quality of life and lung function and to analyze the the presence of predictors of postoperative functional deterioration and the occurrence of complications.


Eligibility Criteria:
Inclusion Criteria:

* Clinical and radiographic diagnosis of bronchiectasis;
* Lack of adequate response to clinical treatment after 1 year of follow-up and / or presence of disease complications;
* Agreement to participate of the study by signing of the Informed Consent Term

Exclusion Criteria:

* Comorbidities that prevent the patient to undergo general anesthesia;
* Musculoskeletal and/or psychomotor disability to perform pulmonary function tests and cardiopulmonary exercise tests;
* Inability to understand the quality of life questionnaires;
* Age over 90 years or less 18 years.
Vaginal Douching and Painting in Women Who Underwent Total Abdominal Hysterectomy

Comparison of the effectiveness of povidone-iodine douching and painting for reducing febrile morbidity after total abdominal hysterectomy

Total abdominal hysterectomy (TAH) is the most common gynecologic operation worldwide. The two most common complications after TAH are febrile and infectious morbidities, incidence varying between 5 and 50 percent. After performing TAH, vaginal canal must be breached and closed to be blind-pouch stump. Routing vaginal douching at the night before and on the morning of the surgical date, and intra-operative painting are routinely practiced. However, no good quality of evidence base supports the effectiveness of vaginal douching and painting in preventing febrile and infectious morbidities after TAH.

Eligibility Criteria:
Inclusion Criteria:

* Women who undergoing total abdominal hysterectomy
* Woman who agrees to participate in this study

Exclusion Criteria:

* Women with history of sea-food or iodine allergy
* Women who undergo emergency TAH
* Women who have intestinal resection in this operation
* Women who have active pelvic inflammatory disease before operation
* Women who have fever before operation
* Women who received antibiotic within 1 weeks before operation
* Women who be immunocompromised host
Randomized Evaluation for Failed TAVR

REVIVE TAVR is an acronym for the Randomized Evaluation of Valve-In-Valve versus Explantation for failed TAVR. This is a prospective, multicenter, global randomized trial investigating the safety and efficacy of reintervention for transcatheter heart valve (THV) failure by comparing redo-TAVR (TAV-in-TAV) with TAVR surgical explantation (TAVR-explant) in subjects who are suitable for both options in a real-world clinical setting


Eligibility Criteria:
Inclusion Criteria:

* Heart Team has confirmed eligibility for both TAVR-explant and redo-TAVR for failed THV
* Subject is symptomatic from their failed THV, as demonstrated by NYHA Functional Class ≥II
* Subject and the treating physician agree that the subject will return for all required post-procedure follow-up visits
* Subject meets the legal minimum age to provide informed consent based on local regulatory requirements.

Exclusion Criteria:

* Ongoing sepsis, including active endocarditis;
* Severe dementia (resulting in either inability to provide informed consent for the trial/procedure, prevents independent lifestyle outside of a chronic care facility, or will fundamentally complicate rehabilitation from the procedure or compliance with follow-up visits);
* Other medical, social, or psychological conditions that in the opinion of the Investigator precludes the subject from appropriate consent or adherence to the protocol required follow-up exams;
* Pregnancy or intent to become pregnant for the next 12 months;

Coronary obstruction risk:

- Patients at risk of coronary obstruction may be enrolled into the randomized cohort if the operators determine that redo-TAVR can be safely accomplished with leaflet modification or other coronary protection strategies.
Airway Secretion Clearance in Cystic Fibrosis

The purpose of this study is to compare the effect of three airway secretion clearance techniques (chest physical therapy, flutter device and high frequency chest wall oscillation) on decline in pulmonary function over a three year period in patients with cystic fibrosis.

Study Design: Randomized clinical trial with pulmonary function testing obtained every three months in each of the three treatment groups. Change in slope of FEV1 will be compared. Days of hospitalization and use of oral or IV antibiotics for respiratory tract infection, quality of life, subject satisfaction, and compliance will also be compared.

Sample Size: Enrollment will be completed after 180 subjects have been recruited. Fifteen CF centers will participate.

Subject Selection: Subjects must have the diagnosis of CF, be \> 7 years of age and have an FEV1 \> 45% of predicted.

Prescribed Therapy: Each subject will receive airway secretion clearance twice a day.

Outcomes: Change in slope of FEV1; days of hospitalization and use of oral or IV antibiotics for respiratory tract infection; quality of life; subject satisfaction; compliance.

Eligibility Criteria:
Inclusion Criteria:

* A proven diagnosis of CF as evidenced by a positive sweat test (as documented by a sweat chloride \>60 mEq/L by quantitative pilocarpine iontophoresis), or by the presence of two known CF mutations.
* Aged 7 or older.
* FEV1 \>45% (Knudson).
* Able to perform reproducible maneuvers for spirometry at screening as defined by the American Thoracic Society (ATS) and European Respiratory Society (ERS) guidelines.
* Willing to participate in and comply with the study procedures, and willingness of a parent or legally authorized representative to provide written informed consent.

Exclusion Criteria:

* Hospitalization for complications of CF, or a respiratory exacerbation resulting in - treatment with IV antibiotics within 60 days prior to screening.
* Use of any investigational drug or device within 60 days prior to screening.
* An episode of gross hemoptysis (\>249 ml) within 60 days prior to screening, or during the course of the study.
* A pneumothorax in the six months preceding the study or during the course of the study.
* Patients who are pregnant or become pregnant.
* Patients colonized with Burkholderia cepacia.
TRANSVERSE ABDOMINAL PLANE BLOCK VS. ILIO-INGUINAL ILIO-HYPOGASTRIC BLOCK in PEDIATRIC INGUINAL SURGERY

The ilio-inguinal ilio-hypogastric (IIIH) nerve block remains the gold standard analgesic technique after inguinal surgery in children. Transverse abdominal plane (TAP) block has been reported to provide effective analgesia after lower abdominal surgery in adults. The aim of our study was to compare the analgesic effect of ultrasound-guided TAP block to IIIH nerve block after inguinal surgery in children.

The study aimed to compare the analgesic effect of ultrasound-guided transverse abdominal plane (TAP) block to ilio-inguinal ilio-hypogastric (IIIH) nerve block in children after inguinal surgery. This prospective, randomized study included children aged six months to twelve years, classified as ASA I or II, scheduled for elective unilateral inguinal surgery. Participants received either a TAP block or an IIIH block with bupivacaine following standardized induction of general anesthesia. Analgesics were not systematically administered post-induction. Postoperative pain was monitored for six hours in the hospital, and if the CHEOPS score exceeded 7, paracetamol was administered, with nalbuphine as a secondary option if needed. At home, parents assessed pain using the PPMP score, administering paracetamol and ibuprofen if necessary. Primary outcomes included postoperative analgesia quality, determined by time to first analgesic requirement and the need for analgesics at hospital and home. Secondary outcomes measured included block performance duration, parental satisfaction, and incidence of complications.

Eligibility Criteria:
Inclusion Criteria:

* Children aged 6 months to 12 years
* ASA physical status 1 or 2
* Scheduled for unilateral inguinal surgery

Exclusion Criteria:

* Children scheduled for bilateral surgery or associated procedures (e.g., circumcision)
* Parental refusal
Effect of Oxytocin on Masked Facial Expressions: an fMRI Study

The purpose is to test whether oxytocin has an effect on masked facial expressions

The neuropeptide oxytocin (OXT) has been shown to modulate several aspects of human social cognition. Although the exact mechanisms behind these effects remain unclear, recent research suggests that OXT modulates the perception of cues that are important for interpersonal processing, particularly emotional facial expressions. Using a backward masking procedure and functional magnetic resonance imaging, we investigated the modulatory effects of intranasal OXT on the processing of sub-liminally presented emotional faces. In a double-blind placebo-controlled between-subject pharmaco-fMRI experiment healthy volunteers received either 24IU of intranasal oxytocin or placebo 45mins before they were presented emotional (happy, angry, fearful, sad, disgusting) faces and mirror-reversed neutral faces masked by neutral faces of the same individual. To ensure attentional processing of the faces subjects were required to perform a simple gender decision task in the scanner and a recognition memory task afterwards. All subjects were additionally assessed for their state and trait anxiety and depression as well as empathy. For the analysis, we will use matlab, SPM and SPSS to conduct structural ROI analysis and two Sample t test.

Eligibility Criteria:
Inclusion Criteria:

* Healthy subjects, no smoke or drink alcohol, coffee or other stimulants during the day before Experiment.

Exclusion Criteria:

* history of head injury; pregnancy; uterine cavity operations were took within one year; medical or psychiatric illness; rhinitis in case they may not fully absorb the spray.
Efficacy/Safety of Amlodipine Plus Losartan Versus Amlodipine in Patients With Stage 2 Hypertension

The purpose of this study is to evaluate the blood pressure lowering effects of an amlodipine/losartan combination treatment and amlodipine monotherapy for treatment of Stage 2 hypertensive patients.


Eligibility Criteria:
Inclusion Criteria:

* 18 aged or over
* Patients with blood pressure measured at Visit 1; MSSBP≤180mmHg and MSDBP≤110 mmHg if on anti-hypertensive drugs, 160mmHg≤MSSBP≤199mmHg and 80mmHg≤MSDBP≤119mmHg if not on anti-hypertensive drugs
* Patients with blood pressure measured at Visit 2 were 160mmHg≤MSSBP≤199mmHg and 80mmHg≤MSDBP≤119mmHg

Exclusion Criteria:

* Inability to stop all prior anti-hypertensive drugs safely during wash out period of 3 to 7 days
* ≥ sitSBP 20mmHg or ≥ sitDBP 10mmHg of variation in three measurements from the reference arm selected at Screening
* History of hypersensitivity to dihydropyridines, angiotensin II receptor blockers or thiazide diuretics
* Secondary hypertension or suspected to be
* Continuously took medicinal drugs that might affect blood pressure rather than anti-hypertensive drugs more than 3 months
* Type 2 diabetes mellitus which is not controlled or with type 1 diabetes mellitus
* History of severe neurovascular disease, severe heart disease
* Known as moderate or malignant retinopathy.
* Renal diseases; serum creatinine ≥ 2mg/dl
* Hepatic diseases; increase in ALT or AST ≥ 2xUNL
* Anuria
* Hyponatremia/hypokalemia or hypercalcemia
* Active Gout
* Surgical or medical diseases which might significantly change ADME of medicines
* History of malignant tumor
* Autoimmune diseases
* History of alcohol or drug abuse
* Positive to pregnancy test, nursing mother, woman with an intention of pregnancy
* Considered inappropriate to participate in the clinical trial with any reason, based on investigator's decision

Other protocol-defined inclusion/exclusion criteria may apply
CBT Group for Adolescents With ADHD: a Randomized Controlled Trial

This is the first randomized controlled study that tests the efficacy of a cognitive-behavioral group therapy (CBT) on adolescents with ADHD who were in pharmacological treatment but still presented persistent symptoms.

A multicenter, randomized rater-blinded controlled trial was carried out in a sample of 119 adolescents (15-21 years) and was conducted between April 2012- May 2014. Patients were randomly assigned to 12 group manualized cognitive-behavioural group therapy sessions (n=45) or a waiting list control group (N=44). Primary outcomes were assessed by a blind evaluator (ADHD Rating Scale, Clinical Global Impression Scale for Severity, Global Assessment Functioning) before and after treatment as well as by self-report and parent informant ratings.

Eligibility Criteria:
Inclusion Criteria:

* DSM-IV ADHD diagnosis
* age between 15 and 21 years
* stabilized doses of medication for ADHD for at least 2 months prior to the study
* agreement not to seek out any other psychiatric or psychological treatment during the study.

Exclusion Criteria:

* affective disorders
* anxiety disorders
* psychotic disorders
* personality disorders
* substance use disorders in the past 6 months
* pervasive developmental disorder
* patients with an IQ lower than 85
* patients receiving concurrent psychological interventions.
Reproducibility of the Measurement of the Right Portal Vein Diameter

Although routine ultrasound is offered during the third trimester of pregnancy, less than a quarter of newborns with intrauterine growth retardation (IUGR) are suspected antenatally.

The measurement of the right portal vein (RPV) diameter on the transverse abdominal view at the 32 weeks' scan may be a new a tool for detecting small-for-gestational-age (SGA) at birth. The irregular and collapsed aspect of the right portal vein (RPV) on the third trimester ultrasound could be used for identifying hypoxemic and growth-restricted fetuses.

However, to our knowledge, the only interoperator reproducibility study of this measurement was performed using the same stored images or datasets without performing a new examination.

The main objective of this study is to assess the intra and interoperator reproducibility of the measurement of the right portal vein diameter at the routine third trimester ultrasound.

The secondary objective is to quantify the interoperator reproducibility of the assessment of the aspect, normal or collapsed, of the right portal vein, using an evaluation grid.

Two referees will perform four successive measurements of the diameter of the right portal vein (RPV) during the same ultrasound examination at the third trimester. Each operator will qualify the appearance of the right portal vein as normal or collapsed using an evaluation grid, and will independently performe a series of two measurements using the same method.


Eligibility Criteria:
Inclusion Criteria:

* Women carrying a pregnancy from 30 weeks to 33 weeks either normal or with IUGR,
* Patient without guardianship or curatorship or subordination,
* Patient benefiting from a Social Security scheme

Exclusion Criteria:

* Presence of a fetal malformation,
* Multiple pregnancy,
* Premature rupture of membranes,
* History of bariatric surgery,
* Body mass index (BMI)\> 30 kg / m2,
* Patient benefiting from enhanced protection, namely: minors, persons deprived of their liberty by a judicial or administrative decision, persons staying in a health or social establishment, adults under legal protection.