cyrilzakka/clinical-trials huggingface dataset:
Executive Functions and Preterm Children in 11 to 12 Year Old

Preterm children have a high risk for neurodevelopmental impairments. The impact on motor functions and neurosensory functions is demonstrated but the incidence of executive functions is not described for preterm infants.

It is an epidemiologic, observational, prospective study. All patients, included in the LIFT cohort, in 11 to 12 year old during the period study, are contacted by mail. Patients with congenital anomalies or genetic syndromes are excluded. Children with parents who do not speak French are excluded. Antenatal and postnatal criteria known to be associated with disorders of executive functions are collected as gestational age, sex, multiple pregnancy, intrauterine growth retardation, antenatal or postnatal steroid use, breastfeeding, cerebral injuries and socio-economic status. After a couple of weeks, parents are contacted by a study manager, by phone call, to collect parental consent and answer some parental questions. After consent collect, BRIEF questionnaires are sending. If they wish, parents could give the BRIEF teacher questionnaire to the mean teacher. Teachers send by themselves their response. An informatic version is available with a personal link given especially by mail for each child. All data are anonymous. BRIEF questionnaire is composed of 86 items, exploring 2 main domains: behavior and metacognition. Twenty minutes are necessary to complete questionnaire. In case of no questionnaire return after one month, parents are contacted by phone. The investigators hypothesize a lost to follow-up at 0.25 and no response at 0.35. The response expected is 300 questionnaires.

Eligibility Criteria:
Inclusion Criteria:

* patient in 11 to 12 year old, included in LIFT cohort

Exclusion Criteria:

* Congenital abnormalities including nervous system malformations; genetic diseases; incomplete understanding of written and oral French by parents
Dose Ranging and Dose Frequency of LIPO-102

Dose Ranging and Dose Frequency of LIPO-102


Eligibility Criteria:
Inclusion Criteria:

* Male or non pregnant female
* Good general health
* Sufficient abdominal fat for injections
* Signed informed consent

Exclusion Criteria:

* Known hypersensitivity to study drugs
* Treatment with an investigational agent within 30 days of first dose
Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetics of MBX-2982 Administered Daily for 4 Weeks as Monotherapy in Patients With Type 2 Diabetes

To define the relative efficacy, safety and tolerability profiles of oral daily MBX-2982 at three different daily doses vs. placebo and sitagliptin 100 mg when administered for up to 4 weeks in patients that are treatment-naive or taking a single anti-diabetic medication (non-TZD, non-injectable).

Approximately 100 patients will be randomized in this study, 20 to each of of the three MBX-2982 treatment groups, 20 to placebo, and 20 to the sitagliptin group. Patients will be taking 3 tablets and 1 capsule daily. This sample size provides the minimum number expected to ensure a power of at least 80% to detect a 20% decrease in the weighted mean glucose level associated with an extended mixed meal tolerance test (with 2 standardized meals) relative to placebo after 4 weeks of daily treatment with MBX-2982, assuming a drop-out rate of 20% and a common SD of 25%.

Eligibility Criteria:
Inclusion Criteria:

* History of type 2 diabetes of at least 3 months duration
* Treatment-naïve (not on any anti-diabetic medication) or treated with a single anti-diabetic agent (excluding insulin, exenatide or other GLP-1 analogs, pioglitazone or rosiglitazone)
* HbA1c 7.0-8.5% (inclusive) at screening
* BMI ≥ 26 kg/m2 for patients recruited from U.S or Georgia or ≥ 22 kg/m2 for patients recruited from India

Exclusion Criteria:

* Any history of type 1 diabetes or diabetic ketoacidosis
* History of major upper GI surgery
* Evidence or history of clinically significant GI illness including dyspepsia, PUD, nausea, diarrhea, malabsorption, etc.
* History of outpatient insulin use within last 1 year (insulin use while hospitalized is acceptable)
* Weight loss \> 10 pounds (4.5 kg) in the 3 months prior to screening visit or use of weight loss medications (prescription or OTC) within 30 days of screening
The Effects of Smoking Withdrawal On Resting State Functional Connectivity

The purpose of this study is to see how the brain differs between smoking regularly and after not smoking for 24 hours. The investigators will be using an MRI machine to get the information from adult smokers and non-smokers while they lie in the scanner with their eyes closed. Smokers will be scanned when they have not smoked for 24 hrs and shortly after smoking. It is our hypothesis that brain activity will be altered after not smoking for 24 hours.

The broad objective of this proposal is to identify functional neuroanatomical correlates of changes in brain functional connectivity during smoking abstinence. The investigators will measure changes in regional blood oxygenation levels using fMRI while adult smokers and non-smokers lie in the scanner with their eyes closed. Smokers will be scanned when they are abstinent from smoking for 24 hrs and shortly after smoking. Our primary hypothesis is that smoking abstinence will alter resting state brain activity (or resting state functional connectivity; RSFC) across widely distributed neural networks and that high-resolution fMRI will help in resolving the exact nature of such changes. Data will be analyzed using methods developed in our laboratory and applied to other resting state datasets. All of the procedures used in the study are well validated and introduce only minor risk to participants (e.g. blood draw; MRI).

Eligibility Criteria:
Inclusion Criteria:

* Right handed
* Drug free
* No known health problems
* Currently not taking any medication
* Uninterested in quitting smoking long term

Exclusion Criteria:

* Left handed/ambidextrous
* Currently taking medication
* Interested in quitting long term
Prospective Randomized Trial Evaluating the Utility of Esophageal Stitches During Laparoscopic Fundoplication

This is a prospective trial of the utility of esophageal stitches during fundoplication.

The hypothesis is that recurrence rate may be different with or without the esophageal stitches.

This will be a single center, prospective randomized clinical trial involving patients who require an operation for gastroesophageal reflux disease. This is intended to be a definitive study. All patients will receive the standard operation for reflux: laparoscopic fundoplication. The dissection will be performed by leaving the phrenoesophageal membrane intact in all patients.

One group will undergo laparoscopic fundoplication with 4 esophageal-crural sutures while the other group will not have these placed. The operation, post-operative care, and follow-up plan will otherwise not differ between groups.

Eligibility Criteria:
Inclusion Criteria:

Patients less than 7 years of age requiring fundoplication for gastroesophageal reflux disease who are considered good laparoscopic candidates by the staff surgeon will be considered candidates.

Exclusion Criteria:

1. Hiatal hernia demonstrated on preoperative contrast study, computed tomography, endoscopy, or intraoperative findings.
2. Prior esophageal operation (e.g. esophageal atresia repair, esophageal myotomy)
3. Prior operation for congenital diaphragmatic hernia
4. Patients not considered laparoscopic candidates by the staff surgeon or anesthesiologist (e.g. carbon dioxide retaining lung disease, congenital heart disease, or complex previous abdominal operations)
The Effect of Dexmedetomidine, Melatonin and Pregabalin

Various drugs have been used for the purpose: nitroglycerine, sodium nitroprusside, propofol, beta blockers, calcium channel blockers, higher concentrations of inhalational anesthetics etc. Since all these drugs have certain limitations there was a search for more safe and effective drug

Functional Endoscopic Sinus Surgery (FESS) is done via endoscope and the area is highly vascular thus it becomes important to minimize bleeding, hence we require hypotensive anesthesia.

Dexmedetomidine (a highly selective α2-receptor agonist that has sedative, analgesic, anxiolytic, and opioid sparing effects without significant respiratory depression) it also reduces the need for inhaled anesthetics. dexmedetomidine also minimizes postoperative opioid consumption as well as nausea, vomiting, and anxiety.

Melatonin is a neurohormone mainly secreted from the pineal gland by the suprachiasmatic nucleus. It possesses a circadian secretion pattern and regulates the biological clock; it also offers antiemetic, analgesic, and anxiolytic effects. Due to its effect on both acute and chronic pain, melatonin (available in 5mg tablet form) fulfills a beneficial role in reducing postoperative opioid consumption while minimizing nausea and vomiting.

Pregabalin, whose structure is similar to the inhibitory neurotransmitter gamma-aminobutyric acid (GABA), possesses analgesic and anxiolytic activities and is effective in alleviating the neuropathic component of acute nociceptive pain of surgery. It has also been used as premedication to attenuate the hemodynamic stress response to laryngoscopy and intubation and to decrease intraoperative anesthetic requirement

Eligibility Criteria:
Inclusion Criteria:

- Patients undergoing Functional endoscopic sinus surgery (ASA I \& II)

Exclusion Criteria:

- Hepatic, renal, endocrinal, hematological disorders.

* BMI\>30 kg/m2.
* Patients receiving magnesium supplementation, anticonvulsant drugs or antipsychotic drugs.
* Chronic use of opioids.
* Current treatment with β-blocker or calcium channel blocker.
* Known allergies to any of study drugs.
* Patients refusal to the study
Office-based Radial Expansion Balloon Dilation of the Esophagus and Trachea

Retrospective chart review of UCDMC patients who have undergone esophageal or tracheal balloon dilation to record data including age, gender, diagnosis pre-and post-procedure eating assessment tool, esophagoscopy findings, tracheobronchoscopy findings, and pre-and post-procedure videofluoroscopic findings.

Dilation of the esophagus is performed for strictures, webs, and rings at all levels of the esophagus. Dilation of the trachea is performed for subglottic and tracheal stenosis. Radial expansion balloons have been developed by Bost Scientific Corporation for the purpose of dilating the esophagus and trachea through flexible esophagoscopies. These sequential controlled radial-expansion balloons can be introduced via a guide wire through the working channel of a 5.1 mm transnasal esophagoscope. Traditionally, otolaryngologists have performed esophageal and tracheal dilation per oral under general anesthesia. This technique allows the procedure to be performed in the office, sparing the patient the risk of anesthetics. The purpose of this study is to review the UCDMC experience with esophageal and tracheal balloon dilation using the transnasal esophagoscope.

Eligibility Criteria:
Inclusion Criteria:

* patients who have undergone esophageal or tracheal balloon dilation since 1/1/05
* patients who underwent an attempted dilation since 1/1/05

Exclusion Criteria:

* Younger than 18 years of age
* Those who do not meet the inclusion criteria
Comparing 61.2 Gy Radiotherapy Dose Versus 50.4 Gy Radiotherapy Dose for Locally Advanced Esophageal Carcinoma

The purpose of this study is to determined the best definitive radiotherapy dosage for patients with locally advanced esophageal squamous cell carcinoma.


Eligibility Criteria:
Inclusion Criteria:

* Joined the study voluntarily and signed informed consent form;
* Age 18-75 years; both genders
* Esophageal squamous cell carcinoma confirmed by pathology.
* No radiotherapy, chemotherapy or other treatments prior to enrollment
* Locally advanced esophageal squamous cell carcinoma (T1N1-3M0, T2-4NxM0, TxNxM1 (supraclavicular lymph node metastasis only) (AJCC 8th)
* Use of an effective contraceptive for adults to prevent pregnancy.
* No severely abnormal hematopoietic, cardiac, pulmonary, renal, or hepatic function. No immunodeficiency.
* WBC ≥ 3.5\*109/L, Hemoglobin ≥ 9 g/dL, Neutrophils ≥ 1·5\*109/L, Platelet count ≥ 100\*109/L, ALAT and ASAT \< 2·5 \* ULN, TBIL \< 1·5 \* ULN, and Creatinine \< 1·5 \*ULN.
* ECOG 0-2.
* Life expectancy of more than 3 months.
* Agreement of PET/CT accessment at 25-28 radiotherapy fraction.

Exclusion Criteria:

* Total radiotherapy dose cannot reach 61.2Gy/34Fx in the condition of the nomal tissue dose complying to the standard criteria.
* Esophageal perforation, or hematemesis.
* History of radiotherapy or chemotherapy for esophageal cancer.
* History of surgery within 28 days before Day 1.
* History of prior malignancies (other than skin basal cell carcinoma or cervical carcinoma in situ with a disease-free survival of at least 3 years).
* Participation in other interventional clinical trials within 30 days.
* Pregnant or breast-feeding women or fertile patients who refused to use contraceptives.
* Drug addiction, alcoholism or AIDS.
* Uncontrolled seizures or psychiatric disorders.
* Any other condition which in the investigator's opinion would not make the patient a good candidate for the clinical trial.
Prehabilitation for Adults With End Stage Renal Disease on the Kidney Transplant Waitlist

This pilot study will be a clinical trial to test the feasibility and effectiveness of a kidney transplant (KT) prehabilitation intervention in adults with end stage renal disease (ESRD) who are within 3-6 months of transplantation.

Prehabilitation is the enhancement of functional capacity of a patient to improve their ability to withstand a future stressor. The investigators primary objective is to demonstrate feasibility for prehabilitation in Aim 1 and test whether the number of prehabilitation sessions is associated with increased physical activity. The investigators will formally test whether prehabilitation is associated with a reduction in short term and long term KT outcomes as part of Aim 2. The investigators will test whether there is an effect of prehabilitation on short-term (KT length of stay\> 2 weeks, early hospital readmission and delayed graft function) and long-term (acute rejection (within the first year), 1 year patient and graft survival) outcomes compared to standard of care controls. Participants will be followed for 3-6 months or until they receive a kidney transplant.

Eligibility Criteria:
Inclusion Criteria:

1. Men and women with end stage renal disease who are within 3-6 months of kidney transplantation and are on the kidney transplant waitlist at Johns Hopkins
2. Must be at least 18 years or older at enrollment
3. Must be English speaking
4. Must be enrolled in an ongoing cohort study of adults with ESRD who are being evaluated for kidney transplantation
5. Must be willing to participate in a prehabilitation program and able to give informed consent

Exclusion Criteria:

1. Patients who have any of the following medical conditions will be excluded from the study:

   * Active Angina pectoris
   * Chronic lung disease and daily use of oxygen
   * Cerebral vascular disease
   * Musculoskeletal conditions that would limit participation in prehabilitation
   * Lower- or upper-extremity amputation
   * Orthopedic disorders exacerbated by physical activity
   * Decreased mental capacity
2. Patients who live outside of Maryland will not be included in the study.
Double Regional Anesthesia in Video Assisted Thoracoscopy

Monocentric, randomized, controlled, single-blind study who's aim is to demonstrate the efficacy of the association of paravertebral block and serratus plane block with paravertebral block alone


Eligibility Criteria:
Inclusion Criteria:

* Patient aged 18 to 75 years;
* Programmed for unilateral videothoracoscopy for anatomical resection (segmentectomy, lobectomy);
* Subject affiliated to a social security scheme;
* Subject having signed an informed consent

Exclusion Criteria:

* Chronic treatment with opiates;
* Contraindication to administration of morphine;
* Allergy to local anesthetics or contraindications to the use of ropivacaine;
* Contraindication to the realization of paravertebral blocks and serratus;
* Pregnancy, breastfeeding;
* Severe obesity (BMI \> 40 kg/m²);
* Renal impairment (GFR \< 30 mL/min) or known severe hepatic impairment;
* Difficulties of comprehension preventing the collection of consent and the realization of the study;
Evaluation of WP200 With the Unified Probe (WP200U)

The prevalence of OSAS is estimated at 2% and 4% for adult women and men respectively, most of whom are undiagnosed and untreated. The severity of the disorder is expressed by the Apnea Hypopnea Index (AHI) which is the number of Apnea/Hypopnea episodes per hours of actual sleep and the Respiratory Disturbances Index (RDI) which is an extended index incorporating in addition to the previous episodes also respiratory effort related arousal episodes. The high cost of in-lab full night PSG, together with long waiting lists for sleep studies, have led to the development of a variety of ambulatory sleep study systems.

The primary objective of the study is to evaluate the newly developed WP200 with the unified probe (WP200U) compared to the currently used configuration of WP200 that uses an incorporated Nonin oximetry module in the sleep lab or in the home sleep environment.


Eligibility Criteria:
Inclusion Criteria:

* Age between 5-90
* Subjects that are able to read understand and sign the informed consent form of the study or by parents of subjects that are less than 18 years of age that are either referred or volunteering to undergo an overnight sleep study in the clinical sleep laboratory or at home

Exclusion Criteria:

* Permanent pacemaker.
* Severe lung disease.
* Severe peripheral neuropathy.
* Finger deformity that precludes adequate sensor appliance.
* Using one of the following medications: short/Long acting nitrates (less than 3 hours before the sleep study) or alpha-adrenergic receptor blockers (less than 24 hours before the sleep study).
A Study to Assess the Efficacy and Safety of Nemolizumab (CD14152) in Participants With Prurigo Nodularis (PN)

The primary objective was to assess the efficacy of nemolizumab (CD14152) compared to placebo in participants greater than or equal to (\>=) 18 years of age with prurigo nodularis (PN) after a 16-week treatment period.


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of PN for at least 6 months with: Pruriginous nodular lesions on upper limbs, trunk, and/or lower limbs, at least 20 nodules on the entire body with a bilateral distribution and Investigator Global Assessment (IGA) score more than equal to (\>=) 3 (based on the IGA scale ranging from 0 to 4, in which 3 was moderate and 4 is severe) at both the screening and baseline visits
* Severe pruritus was defined as follows on the PP NRS:

  1. At the screening visit (Visit 1): PP NRS score was \>= 7.0 for the 24-hour period immediately preceding the screening visit.
  2. At the baseline visit (Visit 2): Mean of the daily intensity of the PP NRS score was \>= 7.0 over the previous week
* Female participants of childbearing potential (that is \[i.e,\], fertile, following menarche and until becoming post-menopausal unless permanently sterile) must agree to use at least 1 adequate and approved method of contraception throughout the study and for 12 weeks after the last study drug injection

Exclusion Criteria:

* Body weight less than \< 30 kg
* Chronic pruritus resulting from another active condition other than PN, such as but not limited to scabies, lichen simplex chronicus, psoriasis, atopic dermatitis, contact dermatitis, acne, folliculitis, lichen planus, habitual picking/excoriation disorder, sporotrichosis, bullous autoimmune disease, end-stage renal disease, or cholestatic liver disease (example \[eg\] primary biliary cirrhosis) or diabetes mellitus or thyroid disease that is not adequately treated, as per standard of care
* Unilateral lesions of prurigo (eg, only one arm affected)
* History of or current confounding skin condition (eg, Netherton syndrome, cutaneous T-cell lymphoma \[mycosis fungoides or Sezary syndrome\], chronic actinic dermatitis, dermatitis herpetiformis)
* Participants with a current medical history of chronic obstructive pulmonary disease and/or chronic bronchitis
* Neuropathic and psychogenic pruritus such as but not limited to notalgia paresthetica, brachioradial pruritus, small fiber neuropathy, skin picking syndrome, or delusional parasitosis
* Requiring rescue therapy for PN during the screening period or expected to require rescue therapy within 4 weeks following the baseline visit
* Positive serology results (hepatitis B surface antigen \[HBsAg\] or hepatitis B core antibody \[HBcAb\], hepatitis C (HCV) antibody with positive confirmatory test for HCV (eg, polymerase chain reaction \[PCR\]), or human immunodeficiency virus antibody) at the screening visit
Project inCharge: Increasing the Rate of Comprehensive Eye Care Utilization by Older African Americans Through Community-Based Eye Health Education Program

The study design is a randomized intervention evaluation. Ten senior centers in predominately African American communities in the Birmingham, Alabama will be selected as sites for the educational intervention. Five centers will be randomly assigned to receive an educational intervention communicating practical information about vision, eye conditions and eye care as pertinent to the older African American population. The other five centers will serve as social-contact controls, where participants will receive an engaging information session on a non-health related topic. The primary outcome of interest is the change in percentage of persons receiving comprehensive eye care from pre- to post- intervention. The secondary outcomes are the process outcomes of improvement in knowledge, attitudes, and values about vision, eye conditions, and eye care.


Eligibility Criteria:
Inclusion Criteria:

* African Americans ages \>=60 years residing in the communities targeted for intervention or control activities

Exclusion Criteria:

* Persons who do not speak English, persons who are not community-dwelling.
Ratio of Inferior Vena Cava and Aorta Diameter in Dehydrated Children

* There is no definite tool for measurement of dehydration in children
* Subjective clinical dehydration scale is considered as valuable scoring system, but it cannot be reliable among clinicians sometimes.
* Some authors found Inferior vena cava/Aorta ratio can be a objective marker for dehydration
* However, there is no evidence of correlation between clinical dehydration scale and inferior vena cava/aorta ratio
* We will observe correlation between clinical dehydration scale and inferior vena cava/aorta ratio and change of the ratio according to hydration with intravenous normal saline infusion.


Eligibility Criteria:
Inclusion Criteria:

* All children with dehydration who visit emergency department

Exclusion Criteria:

* congenital heart disease
* bronchopulmonary dysplasia
* renal disease
* liver disease
Study of BMS-754807 Combined With Letrozole or BMS-754807 Alone in Patients With Hormone Receptor-Positive Breast Cancer and Resistance to Non-Steroidal Aromatase Inhibitors

The purpose of this study is to evaluate oral doses of BMS-754807 in combination with letrozole or BMS-754807 alone are safe and efficacious in locally advanced or metastatic hormone receptor positive breast cancer subjects who have progressed with prior non-steroidal aromatase inhibitor treatment.


Eligibility Criteria:
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com.

Inclusion Criteria:

* Postmenopausal women with hormone receptor-positive and HER-2 negative breast cancer
* Disease progression following non-steroidal aromatase inhibitor treatment

Exclusion Criteria:

* Known symptomatic brain metastasis
* Medical condition requiring chronic steroids
* History of Type 1 or 2 Diabetes
* Uncontrolled or significant cardiovascular (CV) disease
* Concomitant second malignancies