cyrilzakka/clinical-trials huggingface dataset:
Feasibility, Safety and Outcome of Transrectal Hybrid-NOTES Anterior Resection

Natural orifice transluminal endoscopic surgery has become an important topic. NOTES access routes give the opportunity to reduce surgical access trauma leading to a more painless surgery and enhancing a fast postoperative recovery. Experience with transvaginal laparoscopic cholecystectomy and transvaginal anterior resection for diverticulitis show that such NOTES procedures are feasible and safe. The complication rate to conventional laparoscopic procedures is similar. Since transvaginal access is impossible in men, an alternative route is missing. There are experimental studies and small case series reporting the feasibility of transrectal anterior resection. However any prospective feasibility study demonstrating the safety of the procedure and functional outcomes (sphincter function) are missing. This study investigates the feasibility, practicability, safety and subjective as well as functional outcome of transrectal hybrid-NOTES anterior resection.

Primary endpoint:

To demonstrate in a prospective cohort study the feasibility (specimen extraction through rectum possible to perform or not), safety (complications graded according to Clavien-Dindo) and postoperative outcome (gastrointestinal quality of life questionnaire and anal sphincter manometry) of routine hybrid-NOTES transrectal anterior resection for benign indication in men and women.

Secondary endpoints:

* quality of life 6 months after surgery
* continence 6 months after surgery
* pain postoperative
* complication rate
* duration of procedure
* lengh of stay

Hypothesis:

The investigators expect specimen extraction through the rectum to be feasible in 80% of cases (in the others an alternative mini-laparotomy has to be performed).

study design: This is an open cohort study on 60 patients. The patients are included before surgery and baseline parameters are put in a registry. There are clinical controls 6 weeks, 3 and 6 months postoperative. 3 and 6 months postoperative as well as preoperative a anorectal manometry is performed.

Inclusion criteria:

- benign indication for left sided colectomy.

exclusion criteria:

* age \<18 years
* patient unable to understand informed consent or missing informed consent
* emergency surgery

power calculation: A feasibility of 80% with a precision of 15% is estimated. Given a 5% drop out rate 36 patients are to be included in the study.

Eligibility Criteria:
Inclusion Criteria:

* benign indication for left sided colectomy

Exclusion Criteria:

* age below 18 years
* unable to understand informed consent of missing informed consent
* emergency surgery
Recurrence and Distant Metastases in Hepatocellular Carcinoma Treated by Transcatheter Arterial Chemoembolization

This project will include at least 40 patients with hepatocellular carcinoma (HCC) who will receive transcatheter arterial chemoembolization (TACE) as a sole method for the management. The serum is collected before and at the 3rd and 7th day after TACE. The serum levels of vascular endothelial growth factor, angiopoietin 2, endostatin and cathepsin L are determined. All patients will be evaluated according to the TNM system for the cancer staging before and 3 months after each session of treatment. The vascularity of tumor, the drug and the dose used for embolization, and the area of infarction will be recorded. These data will be compared with the clinical courses of the patients to obtain the most suitable way in the management of these patients.

Transcatheter arterial chemoembolization (TACE) is the traditional method for the palliative management of patients with hepatocellular carcinoma (HCC). This method will cause tissue hypoxia in area of embolization. Several proangiogenic factors will be induced by the condition of hypoxia. This may have the possibility to promote the proliferation of the residual cancer cells. However, there is no study to clarify this issue. This project will determine the serial changes of serum proangiogenic factors (vascular endothelial growth factor, angiopoietin 2), antiangiogenic factor (endostatin) and cathepsin L before and after TACE. These data will be compared with the clinical courses of the patients to obtain the most suitable way in the management of these patients.

This project will include at least 40 patients with HCC who will receive TACE as a sole method for the management. The serum is collected before and at the 3rd and 7th day after TACE. The serum levels of vascular endothelial growth factor, angiopoietin 2, endostatin and cathepsin L are determined. All patients will be evaluated according to the TNM system for the cancer staging before and 3 months after each session of treatment. The vascularity of tumor, the drug and the dose used for embolization, and the area of infarction will be recorded.

Eligibility Criteria:
Inclusion Criteria:

* patients with hepatocellular carcinoma treated by transcatheter arterial chemoembolization

Exclusion Criteria:

* patients with hepatocellular carcinoma unable to be treated by transcatheter arterial chemoembolization
Evaluation of the Prevalence of Pulmonary Hypertension in Adult Patients With Sickle Cell Disease

Recent data show that pulmonary hypertension (PH), defined by a tricuspid regurgitation jet (TRJ) velocity \> or equal at 2.5m/s on Doppler echocardiography, is present in about 30% of adults with sickle cell disease (SCD) and is associated with poor prognosis. However in SCD the occurrence of PH (defined by mean pulmonary arterial pressure (mPAP)\> or equal at 25 mmHg) is related to at least 3 mechanisms: PH due to hyperkinetic state with high cardiac output (CO) but normal pulmonary vascular resistance (PVR \<160 dynes), or postcapillary PH (pulmonary capillary wedge pressure PCWP \>15 mmHg), or precapillary pulmonary arterial hypertension (PAH) defined by mPAP \> or equal at 25 mmHg, PCWP\< or equal at 15 mmHg and PVR \> or equal at 160 dynes.The aim of this study is to evaluate in a French population of adults with sickle cell disease the characteristics, prevalence and prognosis of pulmonary hypertension.

Consecutive adult patients with sickle cell disease (SCD) had a Doppler echocardiography to evaluate if they had a suspected pulmonary hypertension (PH) on the basis of a tricuspid regurgitation jet (TRJ) velocity \> or equal at 2.5m/s. In this case, a right heart catheterization was performed to confirm or not this diagnosis and its mechanisms. Each included patient was followed every year for 3 years: during each visit, a clinical evaluation was obtained and a Doppler echocardiography. In case of emergence of a suspected PH, a right heart catheterization was performed to confirm or not this diagnosis and its mechanisms.

Three groups of patients were defined: no PH, precapillary PH, and a third group including post-capillary PH and hyperkinetic state. These groups were well defined on the basis of the results of th Doppler echocardiography and right heart catheterisation.

Characteristics of patients and their prognosis were evaluated in each group.

In the same, way, biological study is planned to evaluate some biological markers of the mechanism of PH, and prognostic factors.

Eligibility Criteria:
Inclusion Criteria:

* Homozygous SS sickle cell disease
* Male or female \> 18 years of age
* VOC (Vaso-Occlusive crisis) or ACS (Acute chest syndrome)within 6 weeks of inclusion ("Stable state")
* Signed written Informed consent

Exclusion Criteria:

* Creatinine clearance \< 30 ml/mn
* prothrombin ratio \< 50%
* Severe pneumopathy and TLC (Total lung capacity) \< 70%
A Study to Evaluate Change in Viral Load After OPN-019 in Adults With COVID-19

The purpose of this study is to determine both the magnitude and duration of viral load (copies/mL) reduction after a single dose of OPN-019. The variability associated with viral counts will be utilized to inform the study design of future studies.

A randomized, single dose, adaptive design, proof of concept study in subjects who have tested positive for SARS-CoV-2 infection, are recently infected, and who have mild or no symptoms. Patients will be required to have a score ≤ 2 on the WHO ordinal scale for clinical improvement (Covid-19 Therapeutic Trial Synopsis; Feb 18, 2020). Those meeting the inclusion criteria will be randomized to 1 of 2 arms: OPN-019 (2 sprays per nostril) or SOC. Once randomized, subjects will have baseline nasal and oropharyngeal swabs performed for qRT-PCR viral load and infectious viral particle assessment. The subject will then be administered the study medication. Subsequent nasal and oropharyngeal swabs will be taken at 1 hour, 3 hours, 6 hours, 8 hours, 12 hours, and 24 hours. Cohorts of 10 subjects will be randomized into the study and the results from those subjects will be evaluated to determine if changes in the inclusion criteria or study assessments are required.

Eligibility Criteria:
Inclusion Criteria:

1. men or women aged 18 years and older at Visit 1 (Baseline/Screening)
2. women of child-bearing potential must have a negative urine pregnancy test at Visit 1 (Baseline/Screening)
3. must be confirmed positive for SARS-CoV-2 with RT-PCR testing of a nasal swab taken within 72 hours prior to randomization (first dose of study drug)
4. must have a score ≤ 2 on the WHO ordinal scale for clinical improvement
5. subject must be willing to refrain from any other intranasal instillations (e.g., medications, saline, etc.) for 24 hours after study medication dosing
6. must be capable, in the opinion of the investigator, of providing informed consent to participate in the study.

Exclusion Criteria:

1. women who are pregnant or lactating
2. hospitalized subjects or subjects requiring nursing care for COVID-19
3. currently has one of the clinical signs suggestive of moderate-to-severe COVID-19 illness:

   1. O2 saturation of ≤ 93% on room air at sea level
   2. Heart rate ≥ 90 beats per minute (after seated for 5 min)
   3. Respiratory rate ≥ 20 breaths per minute
4. receiving respiratory support (including any form of oxygen therapy)
5. history of hypothyroidism, goiter, hyperthyroidism, thyroid tumor, autoimmune thyroid disease
6. currently taking medications that contain iodine or currently taking lithium
7. receiving any other investigational drug
8. has an allergy, hypersensitivity, or contraindication to povidone iodine
9. has an allergy or hypersensitivity to any excipients in study medication
10. any serious or unstable concurrent disease, psychiatric disorder, or any significant condition that, in the opinion of the investigator could confound the results of the study or could interfere with the subject's participation or compliance in the study
Serum and Exhaled Breath Condensate MALDI-MS of Lung Cancer. (SPORE)

RATIONALE: Collecting and storing samples of blood and exhaled breath from patients with cancer and from healthy participants to study in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer.

PURPOSE: This research study is collecting and analyzing samples of blood and exhaled breath from patients who have or are at high risk for lung cancer and from healthy participants.

OBJECTIVES:

* To evaluate the ability of proteomic patterns in serum and exhaled breath condensate samples to detect and discriminate lung cancer from healthy and from high-risk individuals.
* To correlate proteomic patterns with tumor behavior.

OUTLINE: This is a multicenter study.

Blood and exhaled breath condensate samples are collected, whenever possible, at a time medically indicated for other purposes (e.g., work-up, pre-op, surgical procedures). The samples are used to produce genetic material (i.e., DNA, RNA) and molecular material (i.e., proteins) that will be stored for future studies, including studies that may not be related to lung cancer. Future genetic studies related to lung cancer may include studies of protein expression patterns via matrix-assisted laser desorption/ionization time of flight mass spectrometry that may serve as predictive molecular markers of lung cancer.

Participants complete a 15-minute Lung Spore Database questionnaire at the time of study enrollment to provide information on demographics (e.g., date of birth, address, phone number), medical and smoking history, personal and family history of cancer and cancer treatment, and current medications. Medical records are reviewed at the time of study enrollment and then over approximately 5 years to obtain information, including test results, associated with the diagnosis of cancer. Participants may also be contacted by phone at a later time to answer questions about their health status.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Meets 1 of the following criteria:

  * Normal healthy volunteer
  * At high risk for lung cancer (e.g., \> 30-pack year history of smoking; chronic obstructive pulmonary disease; or disease-free after surgical resection of lung cancer)
  * Diagnosis of stage I, II, IIIA, IIIB, or IV lung cancer
* Must be willing to allow blood and exhaled breath condensate samples to be stored for genetic testing

PATIENT CHARACTERISTICS:

* Not specified

PRIOR CONCURRENT THERAPY:

* Not specified
The Effect of Scalp Block on Surgical Pleth Index(SPI) During a Mayfield Head-holder Insertion

It is a randomized control trial to compare the surgical plethysmographic index (SPI) response during a Mayfield head-holder insertion in neurosurgical patients who receive a scalp block versus those who do not receive the scalp block after induction of anesthesia with propofol with fentanyl and intubation with cis-atracurium.

Study design is a randomized controlled trial Participants include adult neurosurgical patients scheduled to have a Mayfield head-holder insertion for supratentorial craniotomy Intervention is a scalp block prior to a Mayfield head holder insertion. Comparison is 'no scalp block' Outcome is surgical plethysmographic index (SPI) responses during/after a Mayfield head holder insertion Sample size includes 30 cases (15 cases per arm)

The eligible neurosurgical patients will be randomly allocated, by a concealed randomization process, to receive or not to receive a scalp block after induction and intubation with propofol/fentanyl and cisatracurium. Surgical plethysmographic index, direct arterial blood pressure, heart rate (EEG), End tidal Carbondioxide, Bispectral/entropy (40-60) will be recorded every one minute before/after induction and intubation, before/after the scalp block, and before/after the Mayfield head-holder insertion. The Mayfield head-holder insertion will be performed by a neurosurgeon who will be blinded to the allocated groups.

Data analysis is performed to compare the change of SPI during and after the Mayfield head-holder insertion from the baseline in both groups by using repeated measure ANOVA at the significant level of 0.05.

Eligibility Criteria:
Inclusion Criteria:

* patients will receive a Mayfield head-holder insertion for supratentorial craniotomy

Exclusion Criteria:

* History of chronic hypertension, Diabetes mellitus (DM), coronary heart diseases
* Receiving beta blockers
* BMI \> 30
* Coagulopathy
* severe liver and renal diseases
Blood Sampling Through Peripheral Venous Catheter in Infants

We hypothesize that peripheral venous catheter used for fluid administration can replace venipuncture blood sampling for selected basic analytes and thus reduce pain in infants under 2 years of age.

Multiple venipunctures in hospitalized children result in physical and emotional distress. Recently, we have found that blood sampling via peripheral venous catheter used for fluid administration in children significantly reduces pain and, except for glucose, can replace venipuncture for determining complete blood count and basic chemistry analytics, including white and red blood cell counts, hemoglobin and hematocrit levels, mean corpuscular volume, mean corpuscular hemoglobin level, red blood cell distribution width, platelet count, mean platelet volume, and sodium, potassium, chloride, and urea levels (Berger-Achituv S, Budde-Schwartzman B. Ellis MH, Shenkman Z. Erez I. Blood Sampling through Peripheral Venous Catheters for Selected Basic Analytes in Children. Pediatrics. In press).

The goal of this study is to investigate whether blood sampling via peripheral venous catheter used for fluid administration can significantly reduces pain and replace venipuncture for determining complete blood count and basic chemistry analytics in infants under 2 years of age.

Eligibility Criteria:
Inclusion Criteria:

* Infants under 2 years of age.
* Only hemodynamically stable infants.
* Infants with peripheral venous catheter present for less than 72 hours.
* At least 20 mL of fluids have been infused intravenously at the time of blood sampling.

Exclusion Criteria:

* Infants with signs of catheter-related thrombophlebitis.
Effect of Intake in Bioactive Molecules From Natural or Pasteurised Milk on Gut Maturation in Very Premature Newborns

It seems important to correlate real consumption in bioactives molecules of natural milk versus pasteurized with gut maturation in very preterm infants during small enteral feeding protocol. This objective will be reached through a clinical trial.

One hundred infants born between 28 and 30 weeks of gestational age will be enrolled in our clinical trial in two neonatal units of Marseille; they will receive small enteral feeding protocol with natural or pasteurized milk (according to the Neonatology Department). Infants monitoring will be conducted from birth until 32 weeks of gestational age through extra-uterine growth, dietary type evolution and determination of gut maturation markers levels in blood (Triglycerides and Cholesterol, PUFA, GLP-2, I and L-FABP, Gastrin, Citrullin) and faeces (Calprotectine). We will also look for new biological markers of intestinal growth, via metabolomic approach. Consumption of bioactives molecules (PUFA, sphingomyelin, sCD14, insulin, leptin, lactoferrin, sphingomyelinase acid and BSSL activity) will be quantified in milk 24h-representative samples received by each newborn. The benefits on digestive tract physiology evolution due to the molecules consumption will be observed from the 32nd week until the 36th week or the end of hospitalization.

Eligibility Criteria:
Inclusion Criteria:

* Children whose term is understood(included) between 28 (27SA+6j past(over)) and 30 LIMITED COMPANIES (30 SA+6j).
* Children fed by digestive stimulation.
* Children in 1st day of food(supply)
* Term of certain child.
* Children not presenting a genic syndrome, an evolutionary neurological disease, a pathology malformative.
* Children among whom both holders of the parental authority are of more than 18 years old and are not major protected by the law or deprived of freedom.
* Children among whom the relatives(parents) or the legal representatives accepted the participation of their child in this study, and having signed a lit(enlightened) consent.

Exclusion Criteria:

* Children been born \> 30 LIMITED COMPANIES and \< 28 limited companies.
* Children presenting a genic syndrome, an evolutionary neurological disease, a pathology malformative.
* Children among whom the relatives(parents) or the legal representatives refused that their child participates in the study.
The Goodnight Screen Media Study

To test the timing of evening tablet use on children's circadian phase and sleep (i.e., sleep onset and sleep duration) compared to no screen media use. To explore the effect of evening tablet use on children's inhibitory control and executive function.

The goal of the study is to test the effect of tablet use before bed on the sleep, circadian phase, and executive functioning (EF) of 4-year-olds using a 3-group randomized controlled trial in which children are assigned to receive one of 2 experimental conditions (Group A:1 hour of tablet use in the hour before bed; Group B:1 hour of tablet use 2 hours before bed) or a control condition (no evening screen media use). It is hypothesized that in comparison to no tablet use, daily exposure to tablet use before bed will be associated with a delay in children's circadian phase (e.g., occurring later in the evening/night), a longer sleep latency (i.e., later sleep onset), and shorter sleep duration. It is anticipated that tablet use in the hour before bed will have a greater impact on children's circadian phase and sleep than tablet use 2 hours before bed, or no tablet use before bed. We will explore whether changes in circadian phase and sleep result in poorer performance on measures of EF (i.e., inhibitory control and working memory).

Eligibility Criteria:
Inclusion Criteria:

* preschool-aged children (4.0 to \<5.0 years old) and their parent
* living in the Greater Houston area.
* parent must be a biological parent or legal guardian who lives with the child ≥50% of the time and has a primary role of caring for the child
* parent is comfortable participating in the study and responding to questionnaires in English.
* The child does not have to have access to mobile device, but if they do, the primary device they use has to be an Android OS ≥5.0 either used only by the study child or shared with others, or an Apple iOS ≥14.0 that only the child uses.
* Parent and child must be fluent in English.

Exclusion Criteria:

* The child has a chronic medical condition or takes a medication affecting sleep, or circadian rhythms (e.g., melatonin supplementation, diagnosed sleep disorder, steroid use, etc.) or a diagnosed cognitive or learning impairment affecting EF (e.g., attention deficit hyperactivity disorder).
* Child with blindness or significant vision problems that impacts both screen media use and sleep.
Comedy in Chemotherapy (COMIC) Study

Primary aims: To compare changes in (a) symptoms related to cancer and chemotherapy, (b) a marker of immune function (salivary immunoglobulin A), and (c) a hormonal marker of emotional stress (salivary cortisol) between two groups of patients who view a humorous or non-humorous DVD.

Secondary aim: To describe the perception of patients, caregivers, and nurses regarding the overall intervention experience.

Patients were recruited from the Outpatient Oncology (OPO) clinic at QMC. After signing an informed consent, patients receiving intravenous chemotherapy were randomly assigned to view a 45-minute humorous DVD or non-humorous DVD. The following measurements were obtained before and after patients viewed the DVD: Edmonton Symptom Assessment Scale (ESAS) and the state portion of the Spielberger State-Trait Anxiety Index (STAI-S) to assess symptoms related to cancer and chemotherapy, salivary immunoglobulin A (IgA) to assess immune function and salivary cortisol to assess emotional stress. In addition, patients, caregivers, and nurses were asked open-ended questions after the intervention to ascertain their impression of the overall intervention experience. Multiple analysis of covariance (MANCOVA) were be used to analyze changes in ESAS, STAI-S, IgA and cortisol within and between the two groups.

Eligibility Criteria:
Inclusion Criteria:

1. Diagnosis of cancer
2. Receiving intravenous chemotherapy in the OPO clinic at QMC
3. Has a minimum appointment time in OPO of two hours
4. Age 21 or older
5. Speaks English

Exclusion Criteria:

1. Blind
2. Deaf
3. Diagnosis of head/neck cancer
4. Severe oral mucositis
5. Cognitively impaired

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