cyrilzakka/clinical-trials huggingface dataset:
Medullary Colonic Carcinoma

Retrospective cohort of 10 cases of colonic adenocarcinoma of medullary type, operated between 2000 and 2020 at the University Hospital of Limoges. Collection of relevant data for this rare entity. Subgroup analysis in search of prognostic factors. Comparison of the data from our cohort with those from the literature.

Colorectal cancer (CRC) is the third most common cancer in the world after breast and prostate cancer (1). It is also the second most common cause of cancer death in France (2). Most CRCs are adenocarcinomas. However, there is a distinct subtype of adenocarcinoma of relatively recent recognition, called medullary carcinomas (MC). Its recent recognition as a distinct entity (3) has made it difficult to study the epidemiologic characteristics of this cancer, with little population-based data. The largest cohort studied in the literature is from a US sample of 74 patients seen between 1973 and 2006 (4). The main objective of this French retrospective study is to highlight some common features in this group of patients with medullary colorectal cancers, thus improving our knowledge of this cancer subtype and in particular its prognosis.

Medullary colorectal cancer is a type of cancer with a prognosis of its own, probably different from the most common histological entity, colorectal adenocarcinoma.

This is a retrospective study a cohort of 10 cases of colonic adenocarcinoma of medullary type, operated between 2000 and 2020 at the University Hospital of Limoges. A collection of relevant data was realised for the subgroup analysis in search of prognostic factors for this rare entity as well as a comparison of the data from this cohort with those from the literature.

Eligibility Criteria:
Inclusion Criteria:

* Pathological diagnosis of colorectal adenocarcinoma of medullary type between 2000 and 2020

Exclusion Criteria:

* Absence of anatomopathological confirmation on the surgical specimen
Even-Up to Minimize Secondary Site Pain For Ankle Fracture

Evaluating impact of use of Even-Up shoe wear device for patients treated in CAM boot walker for an ankle fracture. Randomized controlled trial, randomizing patients into control group with boot treatment only versus boot treatment with Even-Up device on contralateral extremity.

A variety of foot and ankle injuries can be treated effectively through the use of a controlled ankle movement (CAM) walker boot. CAM walker boots protect the injured area by restricting foot and ankle motion, providing a stable platform to distribute forces while bearing weight, and allowing the user to rollover the foot during ambulation because of a rocker bottom-shaped sole. Such qualities lend the CAM walker boot to provide ankle support that can be advantageous compared with other commonly used methods. Despite their utility, CAM walker boots create a simulated leg-length discrepancy (LLD), which can result in altered biomechanics during ambulation. Additionally, a LLD can be associated with lower back and joint pain.

We have previously conducted a study that suggests a relationship exists between CAM walker boot treatment and pain at sites other than the extremity being treated. There have been several randomized controlled trials (RCTs) examining a relationship between the correction of inherent LLD with insole inserts and lower back pain. Furthermore, there has been a past RCT and there is a current RCT examining a relationship between the use of the EVENup orthotic shoe lift to correct CAM walker boot simulated LLD and pain at sites other than the extremity being treated. However, these studies were not conducted with patient populations with uniform injuries. To the best of our knowledge, an RCT has not been conducted with the EVENup orthotic shoe lift to examine this relationship in a uniform patient population with nonoperative ankle fractures. This RCT aims to assess the efficacy of the EVENup orthotic shoe lift, towards reducing and even preventing such pain that may be associated with this common course of treatment.

Eligibility Criteria:
Inclusion Criteria:

* Non-operative Treatment of Ankle Fracture
* CAM boot as treatment for injury
* Weight bearing ad lib

Exclusion Criteria:

* Pregnancy
* Non-English speaking
* Recent surgery for lower extremity or back
* Recent other injury to lower extremity or back
* Restricted weight bearing
Cognitive Disorders and Brain Pulse

Following an initial consultation with a memory, resources and research centre (MRRC) doctor, a day hospital may be prescribed to carry out an assessment of cognitive disorders. Patients are then usually followed up in consultation at least once a year, in the framework of a new day hospital and/or consultations with a MRRC doctor.

Patients will be included at the time of the day hospital assessment. All patients received in the day hospital of the MRRC of Tours will be offered the TPI examination. The patients included will be followed up for a period of 5 years and the TPI examination will be repeated according to the same modalities, as part of their follow-up at the MRRC and/or in the context of a new day hospital if necessary.

Eligibility Criteria:
Inclusion Criteria:

* Patient benefiting from a day hospital at the MRRC of the CHU of Tours for assessment of cognitive functions

Exclusion Criteria:

* Refusal of TPI ultrasound examination
* Patients who opposed to data processing
* Patients under judicial protection
Muscle Tissue Oxygenation in Patients With Decompensated Liver Cirrhosis

Patients with decompensated liver cirrhosis exhibit numerous hemodynamic and microvascular changes, i.e., low systemic blood pressure and peripheral vasodilatation. In addition, alterations of tissue oxygenation are described in these patients.

Near-infrared spectroscopy (NIRS) has been proposed as a tool to quantify microvascular dysfunction, for example in patients with sepsis (1) or after trauma (2). NIRS is a non-invasive technique that uses the differential absorption properties of oxygenated and desoxygenated hemoglobin to evaluate skeletal muscle oxygenation (3).

Up to the investigators' knowledge no data exist on NIRS measurements in patients with decompensated liver cirrhosis.

Aims of this study are to evaluate:

* Are there any changes in NIRS parameters in patients with decompensated liver cirrhosis in comparison to other critically ill patients (matched to SAPS II Score) or healthy individuals?
* Is there a correlation with common accepted prognostic scores (MELD Score or indocyanin green clearance) in decompensated liver cirrhosis patients and initial NIRS parameters?
* Does the NIRS trend within the first three days of ICU care in decompensated liver cirrhosis patients receiving fluid replacement therapy correlate with the course of disease?

  1. De Backer D, Creteur J, Preiser JC, Dubois MJ, Vincent JL. Microvascular blood flow is altered in patients with sepsis. Am J Respir Crit Care Med. 2002 Jul 1;166(1):98-104.
  2. Creteur J. Muscle StO2 in critically ill patients. Curr Opin Crit Care. 2008 Jun;14(3):361-6.
  3. Creteur J, Carollo T, Soldati G, Buchele G, De Backer D, Vincent JL. The prognostic value of muscle StO2 in septic patients. Intensive Care Med. 2007 Sep;33(9):1549-56.

Patients fulfilling inclusion criteria and without exclusion criteria will be monitored by NIRS using InSpectra™ technology (Hutchinson, USA) for the first three days of their ICU hospitalization. Besides registration of the NIRS parameters (tissue hemoglobin saturation (StO2), total tissue hemoglobin (THI), dynamic test values by using occlusion testing) baseline characteristics (age, sex, SAPS II Score et.), disease relevant information (etiology of liver cirrhosis, cause of ICU hospitalization) and ICU data (catecholamine therapy, mechanical ventilation, hemodynamic monitoring, fluid therapy) will be recorded. Within the observation time, an indocyanin green-clearance measurement and further laboratory testing will be performed on a daily basis. Data will be pseudonymized and kept confidential according to the guidelines of the local ethics committee.

Eligibility Criteria:
Inclusion Criteria:

* patients with decompensated liver cirrhosis admitted to the medical ICU
* written informed consent signed by the patients or his/her closest family member
* age ≥ 18year

Exclusion Criteria:

* no written informed consent signed by the patients or his/her closest family member
Acupuncture for Post-tonsillectomy Pain Control in Children

A randomized, controlled, single-blinded study comparing conventional postoperative analgesia with paracetamol-on-demand with the same regime plus acupuncture.

The hypothesis is that postoperative treatment of children undergoing tonsillectomy with acupuncture will reduce pain with minimal unwanted effects.

A randomized, controlled, single-blinded study comparing conventional postoperative analgesia with paracetamol-on-demand with the same regime plus acupuncture.

The study will be conducted in accordance with the ethical standards of the Helsinki Declaration and has been approved by the Human Experimentation Ethics Committee of the Ziv Medical Center and the Ministry of Health.

Patients will be recruited through the preoperative clinic conducted on the day before surgery. All parents and children will be given a full explanation of the study by an experienced member of the research team before randomization. The explanation will include the nature of acupuncture and the proposed treatment. Parents will sign an informed consent. Patients randomized to the acupuncture group will have a "trial run" at the time of consenting with a member of the research team experienced with performing acupuncture in children , in order to familiarize the child and family with the procedure.

Eligibility Criteria:
Inclusion Criteria:

• children aged 3-12 years undergoing tonsillectomy with or without adenoidectomy for tonsillar hypertrophy with suspected sleep disordered breathing and for recurrent tonsillar infections.

Exclusion Criteria:

* lack of parental consent
* skin lesions near acupuncture sites
* relevant psychiatric disorder
* coagulopathy
* drug allergies to regular analgesic treatment
* intake of medications possibly affecting postoperative pain
* any child who has received acupuncture treatment in the past or the parents or siblings have received such treatment.
Comparison of Pharmacokinetic, Safety, Tolerability of Alpha-1 MP and Prolastin In Alpha1-antitrypsin Deficient Adults

The purpose of this clinical study (ChAMP - Comparability pharmacokinetics of Alpha-1 Modified Process) is to compare the pharmacokinetic, safety and tolerability of Alpha-1 Proteinase Inhibitor (Human), modified process (Alpha-1 MP) and Prolastin in adult Alpha1-antitrypsin deficient patients. Patients will be infused intravenously with study drug on a weekly schedule for 24 weeks.

The objective of this study is to demonstrate the pharmacokinetic comparability of Alpha-1 MP to Prolastin® in subjects with Alpha1-antitrypsin deficiency.

This study is divided into three 8-week treatment sequences including an initial 8-week double-blind treatment period (with one of the 2 study drugs), a second 8-week double-blind treatment period (with the other study drug), and a third 8-week open-label treatment period (with Alpha-1 MP).

Eligibility Criteria:
Inclusion Criteria:

* Documented diagnosis of congenital Alpha1-antitrypsin deficiency
* Must be receiving augmentation therapy with plasma-derived (human) Alpha1-Proteinase Inhibitor (Prolastin®) for at least one month prior to study entry.
* Signed written informed consent prior to initiation of any study related procedures

Exclusion Criteria:

* Females who are pregnant, breast feeding, or if of child-bearing potential, unwilling to practice adequate contraception throughout the study
* Use of systemic steroids within the 2 weeks prior to receiving study treatment (this does not include the use of inhaled steroids used on a routine or as needed basis).
* Subjects who have had exacerbations of their disease within one month of trial entry.
Effect of Electrostimulation on Glucose Profile of Patients With Type 2 Diabetes

Prevalence of type 2 diabetes (T2D) is increasing worldwide. Lifestyle remains the cornerstone treatment for patients with T2D who are often overweight and sedentary.

Physical activity improves glucose metabolism of patients with T2D : increased glucose utilization during acute muscle activity and improved insulin sensitivity after regular training. The molecular mechanism underlying the effects of exercise on glucose metabolism involves the glucose transporter GLUT-4 which is regulated by physical activity.

Several studies and meta-analysis have showed that physical activity reduces HbA1c by 0.6% on average. In addition, other data suggest a decrease in cardiovascular morbidity and mortality through physical activity.

Recent recommendations for T2D management call for the practice of a structured type of endurance 150 minutes per week and muscle building 2 times per week. However, implementation of these recommendations is low, even when integrated into a therapeutic education program. Adherence is often transient and / or partial. In addition, many T2D subjects are unable to initiate a physical activity because of disabling complications or comorbidities or because of a major cardiorespiratory deconditioning.

Neuro-myo electrical stimulation (NMES) is a physical treatment routinely used in functional rehabilitation to improve muscle strength and volume. The metabolic effect of NMES has been little studied. A pilot study conducted by our team on a population of 18 subjects with T2D showed that a week of daily NMES sessions significantly improved insulin sensitivity of about 25% and up to 50 % for good responders. This result contrasted with the low induced energy expenditure by each 20-minute session of bi-quadricipital NMES, suggesting the possibility of a humoral or neural mechanism associated with NMES.

To complete this work, we plan a randomized cross-over trial with 3 periods (6 weeks without NMES (control), 6 weeks with 3 sessions of NMES per week and 6 weeks with 5 sessions of NMES per week) to assess the glucose profile of sedentary T2D subjects during these different periods. We hypothesize that the bi-quadricipital NMES could improve glycemic control in T2D subjects and thus represent an alternative to traditional physical activity.


Eligibility Criteria:
Inclusion Criteria:

* Type 2 diabetes treated with lifestyle, oral hypoglycemic agents and/or GLP-1 agonists.
* HbA1c : 7 to 10%
* low physical activity (Ricci and Gagnon score below 27)
* Insulin-resistance (at least one criteria out three):
* Waist circumference \> 80cm in women and \> 94cm in men
* Triglycerides \> 150 mg/dl
* HDL-c \< 50 mg/dl for women, \< 40 mg/dl for men

Exclusion Criteria:

* type 1 diabetes
* pregnancy
* intense usual physical activity
* pace maker
* seizure
* knee or neuromuscular pathology
Impact of Diet on Capsule Endoscopy

Capsule endoscopy studies are used for the diagnosis of small bowel mucosal lesions. Since capsule endoscopy depends on the small intestinal peristaltism, the food intake - especially the amount of fat ingested - after the ingestion of the capsule may have an impact on the capsule endoscopy transit time and thus its diagnostic yield. As a consequence, an open-label randomized pilot study was designed to determine wether increased dietary intake of fat after the ingestion of the capsule endoscopy may influence small intestinal transit time and thus the diagnosis of small bowel lesions.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients undergoing capsule endoscopy study

Exclusion Criteria:

* Not being able to follow a diet with increased amount of fat
Recombinant Human Leptin Therapy Effects on Insulin Action

Leptin therapy improves insulin sensitivity in people with leptin-deficiency but it is not known whether it improves insulin action in persons who are not leptin deficient. The purpose of the present study was to determine whether leptin therapy has effects on insulin action in obese subjects with type 2 diabetes mellitus (T2DM). A randomized, placebo controlled trial was conducted in obese subjects with newly-diagnosed T2DM. Subjects were randomized to treatment with placebo, low-dose, or high-dose leptin. Insulin sensitivity was measured.

Leptin therapy improves insulin sensitivity in people with leptin-deficiency but it is not known whether it improves insulin action in persons who are not leptin deficient. The purpose of the present study was to determine whether leptin therapy has weight loss-independent effects on insulin action in obese subjects with type 2 diabetes mellitus (T2DM). A randomized, placebo controlled trial was conducted in obese subjects with newly-diagnosed T2DM. Subjects were randomized to treatment with placebo (saline), low-dose (30 mg/d), or high-dose (80 mg/d) recombinant methionyl human (r-met hu) leptin for 14 days. Multi-organ insulin sensitivity before and after treatment was evaluated by using the hyperinsulinemic-euglycemic clamp procedure in conjunction with stable isotopically labelled tracer infusions to measure glucose, glycerol and fatty acid kinetics.

Eligibility Criteria:
Inclusion Criteria:

* diagnosed with type 2 diabetes for less than ten years
* Body mass index 25 - 40
* hemoglobin A1C 7.5% - 12.0%
* fasting blood glucose between 90 and 240mg/dL

Exclusion Criteria:

* smoking
* pregnancy
* diabetes medications
* regular exercise (more than 3 hours per week)
* uncontrolled hypertension: systolic blood pressure greater than 160 or diastolic blood pressure greater than 95
IT-Supported Early Treatment Of Childhood Overweight

The goal of this exploratory/ developmental study is to develop and evaluate an integrated information system, Healthy Eating and Activity Today (HEAT), for promoting self-care in overweight children. HEAT is comprised of two components: 1)Telephone Linked Care-HEAT (TLC-HEAT), a self-care intervention delivered at home through totally automated telephone conversations; and 2) Primary Care-HEAT (PC-HEAT), a primary care intervention linked with TLC-HEAT and delivered through an electronic health record (EHR). The HEAT system will guide children in the early stages of overweight, i.e., children with Body Mass Index (BMI) 0-3 BMI points above the 95th percentile for age and gender, toward healthy weight management and assist the child's parent(s) and primary care provider (PCP) to support the child's efforts.

For this project we will: 1) develop TLC-HEAT for use by children in the earliest stage of overweight and their parents; 2) integrate TLC-HEAT with an electronic health record to provide child- and parent-reported behavior summaries combined with evidence-based decision support to primary care providers (PCPs) at the point-of-care (PC-HEAT); and 3) conduct a pilot study of the combined HEAT system to explore the appropriateness of conducting a larger, randomized clinical trial in the future.

Eligibility Criteria:
Inclusion Criteria:

* Children will be enrolled in the study if they meet a set of eligibility criteria which includes:

  1. 0-3 BMI points above the 95th %ile for age and gender
  2. age 9-12 years old
  3. a PCP at BMC
  4. an English speaking child and parent (based on interviewer assessment).

Exclusion Criteria:

* Children will be considered ineligible for the study if they:

  1. have a health condition for which dietary recommendations in TLC-HEAT would be contraindicated
  2. have cognitive impairment (not in a mainstream academic class in school)
  3. have a terminal illness, current or former diagnosis of an eating disorder, or other diagnosis that the PCP deems should exclude them from participation
  4. plan to move away from the Boston area in less than 12 months
  5. are participating in another clinical weight treatment program.
* Initial screening will be done by research assistants over the phone.
Performance of Two Silicone Hydrogel Toric Contact Lenses

Evaluation of the clinical performance of two toric contact lenses in a 2-week, single masked (subject), daily wear, randomized, bilateral, parallel group study.


Eligibility Criteria:
Inclusion Criteria:

* Be between 18 and 45 years of age.
* Sign Written Informed Consent (See separate document).
* Be an existing successful daily wear toric soft contact lens.
* Require a visual correction in both eyes (monovision or uniocular fitting is NOT allowed).
* Does not require presbyopic correction (can read J1 @ normal reading distance).
* Have a sphere requirement in the range -1.00 and -5.00D (-5.25D refractive)
* Have refractive astigmatism between 0.75D and 2.50D in both eyes.
* Achieve visual acuity of 20/30 or better in each eye with spherical distance correction.
* Have normal eyes with no evidence of abnormality or disease. For the purposes of this study a normal eye is defined as one having:

  * No amblyopia.
  * No evidence of lid abnormality or infection.
  * No conjunctival abnormality or infection.
  * No clinically significant slit lamp findings (i.e. stromal edema, vascularisation, infiltrates or abnormal opacities).
  * No other active ocular disease.

Exclusion Criteria:

* Requires concurrent ocular medication.
* Clinically significant (Grade 3 or 4) corneal stromal haze, corneal vascularisation, tarsal abnormalities, bulbar hyperemia, limbal hyperemia, or any other abnormality of the cornea that would contraindicate contact lens wear.
* Corneal staining Grade 3 in more than one region.
* Has had refractive surgery. Has had eye injury/surgery within 8 weeks immediately prior to enrolment for this study.
* Abnormal lacrimal secretions.
* Pre-existing ocular irritation that would preclude contact lens fitting.
* Keratoconus or other corneal irregularity.
* Polymethyl methacrylate (PMMA) or Rigid Gas Permeable (RGP) lens wear in the previous 8 weeks
* Extended lens wear in last 3 months.
* Any systemic illness which would contraindicate lens wear or the medical treatment of which would affect vision or successful lens wear.
* Diabetic.
* Infectious disease (e.g., hepatitis, tuberculosis) or an immunosuppressive disease (e.g., HIV).
* Pregnancy, lactating or planning a pregnancy at the time of enrolment.
* Participation in any concurrent clinical trial or in last 60 days.
ATAGLU: Study of Glucose Metabolism in HIV Positive Patients That Switch From Another Protease Inhibitor to Atazanavir

The association between HIV infection , insulin resistance and diabetes mellitus is the topic of many studies that have attempted to analyze the problem from different points of view. In fact, the risk of insulin resistance in HIV-positive patients on antiretroviral therapy seems to depend not only on the same factors that determine its incidence in the general population , but also on the effects of antiretroviral therapy on glucose metabolism. To confirm this observation, studies that have evaluated the incidence of diabetes in patients with HIV infection on antiretroviral therapy have shown that the incidence of diabetes in infected individuals is significantly higher than that observed in the uninfected population. Moreover others preliminar stadies observed that protease inhibitors may induce hyperglycemia and diabetes mellitus. Anyway at this moment no large data are available that indicate the utility to modify the antiretroviral therapy in HIV positive patients with a damage of glucose metabolism.

ATAGLU is a cohort composed by HIV positive patients in effective and stable combined antiretroviral therapy (cART) with undetectable viral load. All patients studied had carried out a therapy with Lopinavir/Ritonavir (LPV/r) + optimal backbone therapy (OBT) and then in part switch to Atazanavir (ATV) + OBT or Atazanavir/ritonavir (ATV/r) + OBT , in part continue with LPV/r + OBT .

The objective was to characterize the changes of carbohydrate profile of a cohort of patients who made a switch from a regimen with LPV/r to boosted or unboosted ATV.


Eligibility Criteria:
Inclusion Criteria:

* HIV postive patients
* Patients on stable and effective antiretroviral therapy with a Protease Inhibitor

Exclusion Criteria:

* use of Atazanavir before the enrolment
* pregnancy