cyrilzakka/clinical-trials huggingface dataset:
Optical Imaging of Gastrointestinal Biopsy Samples and Their Correlation With Histology

To develop novel optical imaging technologies for use as a non-destructive and minimally invasive tool for detection and diagnosis of various diseases that affect the gastrointestinal system.

The investigators have previously developed optical imaging systems that have been able to provide highly detailed images of tissue structures in multiple application areas including Cardiology, Gastroenterology, and Pulmonology. They are looking to continue the advancement of these various technologies under development.

The population will include subjects who are undergoing elective esophagogastroduodenoscopy with biopsy, colonoscopy with biopsy, and/or endo-mucosal resection.The endoscopist will take no more than 3 biopsies in addition to the standard of care biopsies.

The study will be optical imaging of the ex vivo GI specimens that are being collected. Specimens will be collected for research purposes only. Offline analysis of the samples will be performed, and optical imaging findings will be correlated with the pathology findings. This will require review of the medical record to link the findings of the imaging with the pertinent medical information. Samples will be de-identified and subjects will be assigned a unique number. The tissues will be placed in marked containers labeled "for research purposes only". The samples collected will be brought to the Tearney Research Laboratory for imaging and processing. The Optical imaging of the tissue samples will not affect the standard of care procedure.

Eligibility Criteria:
Inclusion Criteria:

• Scheduled for an elective esophagoduodenoscopy and/or colonoscopy

Exclusion Criteria:

• According to standard of care at MGH endoscopy department.
Re-infusion of Unwashed Shed Blood During Off-pump Surgery

To assess the efficacy and side-effects of re-infusion of unwashed shed blood during off-pump coronary artery surgery using a novel cardiotomy circuit.

Introduction Blood transfusion is often required during cardiac surgical operations, and may be associated with known risks and complications. Off-pump coronary artery surgery has been shown to be associated with reduced need for blood transfusion, and cell-savers are widely used as an additional method for reducing blood transfusion demands.

Auto-transfusion of unwashed suctioned blood intra-operatively is thought to increase the inflammatory response and infective complications, but data related to this approach are scares.

Aims

To assess the effects and benefits of using an isolated cardiotomy circuit for re-infusion of unwashed shed blood during off-pump surgery and compare it to the conventional no re-infusion technique. Assessments will focus on:

* clinical outcome
* transfusion requirements
* inflammatory response
* alveolar/arterial oxygen pressure gradients
* cognitive status
* cost-benefit

Study design A prospective study involving patients undergoing off-pump coronary artery bypass surgery. Patients will be randomized to two groups; an isolated cardiotomy circuit for re-infusion of unwashed shed blood will be used in group (a) and the conventional no re-infusion technique will be used in group (b).

Participants Patients undergoing off-pump coronary artery bypass surgery.

Setting Damascus University Cardiac Surgery Hospital

Eligibility Criteria:
Inclusion Criteria:

* All patients undergoing isolated off-pump coronary artery bypass surgery between March 1st, 2024 and March 31st, 2026.

Exclusion Criteria:

* Missing data.
* Patients outside the study period.
* Patients under the age of 40 years or over the age of 75 years.
* Patients with impaired left ventricular function (EF less the 40%).
* Patients with history of renal failure, hepatic failure, CVA, or TIA.
* Patients who have not stopped anticoagulants (except aspirin) for 4 days preoperatively.
* Emergency operations.
Comparison of Remnant-Preserving Anterior Cruciate Ligament Reconstruction With Healthy Controls

Anterior cruciate ligament reconstruction stabilizes the knee joint biomechanically and returns the patients back to the sportive activities. Numerous techniques exist to perform an anterior cruciate ligament reconstruction surgery. Remnant- preserving reconstruction technique is performed to increase surgery success rates and to accelerate the post-surgical return to sport process. In general, there is no consensus regarding the clinical outcomes of remnant-preserving anterior ligament reconstruction over standart procedure. The purpose of this study is to compare the patients who had remnant-preserving anterior cruciate ligament reconstruction with healthy controls in terms of muscle strength and proprioception.


Eligibility Criteria:
Inclusion Criteria:

* Anatomical single-bundle ACL reconstruction with AM portal technique using hamstring autograft due to full-thickness ACL tear,
* Endobutton technique was used for femoral fixation,
* Not having any trauma or surgery on the opposite knee,
* Patients with a follow-up period of at least 12 months after surgery.

Exclusion Criteria:

* Fracture of lower extremity accompanying anterior cruciate ligament tear; posterior cruciate ligament, inner and outer lateral ligament tears,
* Patients who have undergone previous surgery on the knee to be evaluated,
* Cases with repeated anterior cruciate ligament reconstruction,
* Having a history of knee joint arthritis (osteoarthritis, inflammatory arthritis),
* Cases with neurological disease will be excluded from the study.
Physiological Effect of Ataulfo Mango (Manguifera Indica) Beverage in Exercise

The aim of this study is to assess the antioxidant capacity of two mango base beverages (AM1, AM2), against exercise-induced oxidative stress.

Introduction. The post-consumption physiological effect of mango cv. "Ataulfo" pulp (MP) and peel (MC) in humans before exercise has been poorly evaluated.

Objective. To evaluate the physiological response, to consumption of two mango base beverages, AM1 (200g MP/ 600mL water) and AM2 (160g MP; 40g MC / 600mL water), before and after a submaximal exercise test.

Methods. The antioxidant profile and physicochemical characteristics of AM1 and AM2 were evaluated. Several cardiorespiratory, anthropometric and body composition parameters of 19 university students, prior to the consumption of AM1, AM2 and water, were evaluated in three non-consecutive sessions (self-control cases). The glycemic, lactic and antioxidant (FRAP), uric acid (AU), reduced glutathione (GSH) and lipid oxidation (TBARS) and protein carbonyls (PC) responses were evaluated in plasma before and after an incremental cycle ergometer exercise test.

Eligibility Criteria:
Inclusion Criteria:

* healthy male
* university student
* no alcohol, cigar or drugs consumption

Exclusion Criteria:

* no antioxidant supplement or ergogenic consumption
* health issues with performing physical activity
Eval 3-Drug Therapy Diethylcarbamize, Albendazole and Ivermectin That Could Accelerate LF Elimination Outside of Africa

This study will determine if a combination of 3 drugs used to treat the infection that cause lymphatic filariasis (LF) due to Wuchereria bancrofti infection are more effective in killing or sterilizing the adult worms compared to just 2 of the 3 drugs that usually given to treat this infection. The three drugs used together are called albendazole (ALB), ivermectin (IVM) and diethylcarbamazine (DEC). The usual treatment in Papua New Guinea (PNG) for lymphatic filariasis are DEC and ALB. A combination of these 3 drugs has not been previously used to treat LF.

This study will determine whether a single dose of the triple drug regimen of DEC/Iver/Alb is non-inferior to annual treatments with DEC/Alb in inducing sustained clearance of Mf in LF infected subjects (\>50 Mf/ml) at 36 months post-treatment. This study also tests the hypothesis that single dose of triple drug is super in sustained clearance of microfilariae compared to single dose of DEC/ALB.

There will be 3 treatment arms as follows:

1. The comparator (standard treatment) DEC 6 mg/kg + Alb 400 mg administered annually (at 0, 12, and 24 months).
2. DEC 6 mg/kg + Alb 400 mg given once
3. DEC 6 mg/kg + Alb 400 mg + Iver 200 µg/kg administered once only at the beginning of the RCT (0 month).

Eligibility Criteria:
Inclusion Criteria:

* Men and women 18-65 years
* \>50 mf/ml in finger stick blood samples
* Willing to give informed consent

Exclusion Criteria:

* Prior treatment for LF within last 5 years
* Pregnant (do pregnancy test)
* Hemoglobin \< 7 g/dl
* permanent disability, serious medical illness that prevents or impedes study participation and/or comprehension
* AST/ALT and creatinine \> 1.5 upper limit of normal.
* Urine dipstick with glucose ≥ 2+ and/or protein ≥ 2+
Causes Associated With Small Fiber Neuropathy (SFN).

Small fiber neuropathy (SFN) is an injury of cutaneous nerve fibers, mainly by a decrease in their density within the cutaneous tissue. The symptomatology associated with this SFN is broad with symptoms that are essentially sensory, but also autonomic. The etiologies of SFN are numerous (diabetes, drug, infectious, immunological...) and clinically non-specific, justifying a broad etiological assessment. The appearance of staged skin biopsies in the SFN balance sheet has greatly helped to improve diagnosis.

Despite this, a significant part of SFN remains without associated etiology and is considered idiopathic.

As the distribution of the different causes of SFN remains a missing data to date, the completion of this cohort study by one of the SFN reference centres should make it possible to establish the prevalence of SFN causes over a large population.

Only patients with clinical symptoms that may be related to SFN and who have been sampled for SFN, positive or not, will be eligible for recruitment.

The result of the anatomopathological sampling will allow patients to be separated into two groups, with or without SFN.

The main judgement criteria will be the prevalence of etiologies associated with SFN: diabetes, medication, systemic lupus erythematosus, Gougerot-Sjögren syndrome, amylosis, dysthyroidism, alcoholism, vitamin B12 deficiency, HIV infection, hepatitis C, paraneoplastic syndrome, hereditary disease (Fabry disease, Friedreich ataxia,...), idiopathic, others.


Eligibility Criteria:
Inclusion Criteria:

* Age of majority (\>18 years old)
* Clinically managed patient at Brest University Hospital
* Patient who had a skin biopsy with anatomopathological examination for SFN performed at the University Hospital of Brest

Exclusion Criteria:

* Under age of majority (\<18 years old)
* Patient not followed at Brest University Hospital
* Refusal to participate to the study
Study of the Consumer Use of a New Home Test to Measure Sperm Concentration

The objective of the study is to evaluate the agreement in measurement of sperm concentration in human semen between lay users with TRAK and a recognized reference method. The study will also include the measurement of matched samples by TRAK when tested by healthcare professionals trained in use of the TRAK device.


Eligibility Criteria:
Inclusion Criteria:

Subjects (Donor/Tester)

* Generally healthy (apart from fertility or reproductive care), ambulatory, and have absence of chronic conditions or treatments, except those related to fertility and reproductive care
* 20 - 50 years of age inclusive
* Male sex (subjects providing and/or testing human semen specimens)
* For males providing human semen specimens, either healthy subjects or men receiving health care for any one or more of the following reasons:

  * Partner in a couple having difficulty conceiving
  * Diagnosed with male factor infertility
  * Post-vasectomy patients
  * Post-vasectomy reversal patients

Testers Only

* Be able to provide signed Informed Consent
* 20 - 50 years of age inclusive

Exclusion Criteria:

* Any medical or personal issue that would impair the ability of the subject to adhere to the protocol (e.g. substance abuse, neurological disorders)
* Patients currently taking investigational drugs or who are active participants in a treatment trial for any condition
* Unable to speak, understand, or write English
* Mental illness that would interfere with understanding during the discussion of Informed Consent or that would compromise ability to follow the study protocol including, but not limited to, review of the TRAK™ Instructional Booklet, semen specimen collection, and semen specimen testing.
Systemic Management in Extremely Preterm and Extremely Low Birth Weight Infants

to estimate incidences of major complications, such as bronchopulmonary dysplasia, death, and delivery room resuscitation among extremely preterm and extremely low birth weight infants in Northern China

to estimate incidences and risk factors of bronchopulmonary dysplasia, death, and delivery room resuscitation among extremely preterm and extremely low birth weight infants in Northern China

Eligibility Criteria:
Inclusion Criteria:

1. born between January 1, 2015, and December 31, 2018;
2. a birth weight \<1000grams or a gestational age \<28 weeks;
3. admitted within 72 hours after birth.

Exclusion Criteria:

No medical history in the electronic record
Smell Exploration in Patients With Nasal Polyposis : Study by Functional Magnetic Resonance Imaging

Nasal polyposis (NP) is a disease affecting 4% of the population. This disease is frequently accompanied by olfactory disorders (41%-84% of patients) that affect patients' quality of life.

The aim of this study is to show brain activity differences in olfactory areas before and after surgery in each patient and between patient groups (normosmic, hyposmic and anosmic one) using functional Magnetic Resonance Imaging (fMRI). Brain activity will be measured by the intensity of brain signals and of the size of olfactory areas during olfactory stimulation before and after surgery. We suppose that fMRI could predict whether or not the patient will be able to recover smell after surgery.


Eligibility Criteria:
Inclusion Criteria:

* Patients with nasal polyposis managed in the department of otorhinolaryngology and head and neck surgery of Nancy University Hospital,
* Adult Patients,
* Justifying a surgical treatment for nasal polyposis,
* Present hyposmia, anosmia or normosmia before surgery (confirmed by threshold and identification tests of the Sniffin' Stick kit),
* Affiliated with or beneficiary of a social security scheme,
* Having received complete information about the study and having signed an informed consent form.

Exclusion Criteria:

* General contraindications to Magnetic Resonance Imaging,
* Female of childbearing age without effective contraception,
* Persons referred in Articles L. 1121-5 to L. 1121-8 and L1122-2 of the Public Health Code,
* Qualitative sense of smell disorder (cacosmia, hyperosmia, phantosmia, parosmia),
* Smell disorders with neurological, post-traumatic, or neurodegenerative origin.
In-line Filters on ICU

The purpose of this study is to determine whether the use of 0.2/1.2 microliter in-line filter reduces the incidence of severe vasoplegia comparing to the 5 microliter filter.


Eligibility Criteria:
Inclusion Criteria:

* all patients

Exclusion Criteria:

* Younger than 18 years
Comparison of Two Liver Dialysis Systems : MARS Versus SPAD in Severe Liver Failure

A critical issue of the clinical syndrome in liver failure is the accumulation of toxins not cleared by the failing liver. Based on this hypothesis, albumin dialysis is used to remove those substances. Albumin dialysis with recirculation (MARS) is the most used system but required specific system and expert environment. Alternative system without recirculation (SPAD) is less expensive and can be realised in critical care services trained to extrarenal epuration. The primary objective of this study is to compare biological and clinical efficacy, pulsatility index of middle cerebral artery modification and tolerance of both systems.

This is a prospective, open, cross-over comparative study of two albumin dialysis system. Each patient will receive the two systems in an randomly assessed order. Patients are divided up according to bilirubin plasmatic level. (250µmol/L to 400 µmol/L and \>400µmol/L).


Eligibility Criteria:
Inclusion Criteria:

* severe hepatic failure on acute liver failure or acute on chronic liver failure
* hyperbilirubinemia (total plasmatic bilirubin level above 250µmol/L)
* hepatic encephalopathy or pruritus or hepatorenal syndrome.
* waiting for liver function recovery or liver transplantation
* Signed written informed consent by patient or patient's legally appointed representative or reliable person
* affiliation to social security

Exclusion Criteria:

* contraindication to extra-renal epuration
* hypersensibility to albumin or excipients
* patients for whom 2 albumin dialysis treatment cannot be considered
A Study of 3HP-2827 in Treatment of Unresectable or Metastatic Solid Tumors With FGFR2 Alterations

The study is being conducted to evaluate the safety, tolerability, efficacy, pharmacokinetics, and pharmacodynamics of 3HP-2827 in the treatment of unresectable or metastatic solid tumors with FGFR2 alterations.


Eligibility Criteria:
Inclusion Criteria:

* The patient is willing and able to provide written informed consent and has the ability to comply with the study protocol
* Men or women, age ≥ 18 years at the time of signing informed consent.
* Histologically or cytologically confirmed surgically unresectable, locally advanced, metastatic solid tumor.
* ECOG score is 0 or 1.
* An expected survival of ≥ 12 weeks.
* Evaluable or measurable disease per RECIST v1.1.
* Adequate organ function, as measured by laboratory values.

Exclusion Criteria:

* Active brain metastases.
* Have other malignancies within the past 3 years.
* The toxicity from previous anti-tumor treatment has not recovered to ≤ grade 1.
* Clinically significant corneal or retinal disease/keratopathy.
* Clinically significant cardiovascular disorders.
* Failure to swallow, chronic diarrhea, or presence of other factors affecting drug absorption.
* Known to be allergic to any study drug or any of its excipients.
* Assessed by the investigator to be unsuitable for participation in this study.
Exercise Effects on Sarco-Osteopenia in Older Men

The study determined the effects of predominately resistance type exercise in combination with protein supplements on parameters of sarcopenia and osteopenia (sarco-osteopenia) in older, community dwelling men with sarcopenia and -osteopenia over 18 months.


Eligibility Criteria:
Inclusion Criteria:

* Sarcopenia according to Baumgartner et al.(SMI: \> -2 SD\* T-Score)
* Osteopenia at the lumbar spine or hip according to WHO (\> -1 SD T-Score)
* community dwelling people
* able to transfer to our lab

Exclusion Criteria:

* secondary osteoporosis
* history of hip fracture
* medication/diseases that relevantly affect muscle/bone metabolism (last 2 years)
* alcohol abuses of more than 60 g/d ethanol
* cardio-vascular diseases that prevent exercise
* very low physical capacity that prevent exercise in a group setting

SD: Standard Deviation
Incidence of Iatrogenic Diseases on Hospital's Emergency Consultations

French population grows older year after year: 24.3% people were over 60 years old in 2006 against 20.6% in 2000 and the expected number might be over 33% in 2050.

The elderly suffer from lots of illnesses, so they usually take lots of drugs. Therefore, this drug use is most likely to have adverse drug reactions.

Finally, according to Health Ministry, the number of emergency department consultations doubled from 1996 to 2016.

Consequently, it is interesting to study the impact of drug iatrogenic effects on emergency consultations.

It would help to prevent these adverse drug reactions as we prescribe those drugs : First, do not harm.

This will be a retrospective study.

The number of patients will be defined by the number of visits during a random draw of 10 emergency department consultation days between 21st June 2018 and 22nd September 2018 in Toulon - La Seyne sur Mer public hospital.

There are between 100 and 300 emergency department consultations per day in this hospital so the estimated number of patients will be between 1000 and 3000.

Every patient who came to hospital for a consultation in emergency department during this period of time will be included in the study except those who expressed their opposition to their data collection and treatment.

Each patient will be anonymized with a code defined as follows : N(ame) L(ast name) 001 (chronological inclusion number)

Information of the patients involved in adverse drug reactions will be extracted and a description of this patient sample will be made.

Eligibility Criteria:
Inclusion Criteria:

* Man or woman over 18 years old
* Consultation in emergency department of Sainte Musse or La Seyne-sur-Mer hospital between 21st june 2018 and 22nd september 2018 included
* Consultation of the patient in emergency department during the 10 day random draw of the research (from 00h01 to 23h59)
* Consultation in emergency department because of a iatrogenic reason

Exclusion Criteria:

* Dead patients
* Patient's opposition
Safety, Tolerability and Pharmacodynamics After Oral Administration of BIIF 1149 BS in Healthy Male Volunteers

The objective of the study is to obtain information about the safety and tolerability of BIIF 1149 BS45 (single dose: 40, 65, 100 mg), to determine the pharmacologically active dose (range) by performing a citric acid challenge test and to obtain preliminary pharmacokinetic data.


Eligibility Criteria:
Inclusion Criteria:

* Healthy males, based on a complete medical examination
* Age range from 21 to 50 years
* +/- 20 % of their normal weight (Broca-Index)
* Written informed consent

Exclusion Criteria:

* Volunteers will be excluded from the study if the results of the medical examination or laboratory tests are judged by the clinical investigator to differ significantly from normal clinical values
* Volunteers with known gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
* Volunteers with diseases of the central nervous system (such as epilepsy) or with psychiatric disorders
* Volunteers with known history of orthostatic hypotension, fainting spells or blackouts
* Volunteers with chronic or relevant acute infections (especially respiratory infections, cough)
* Volunteers with history of allergy/hypersensitivity (including drug allergy) which is deemed relevant to the trial as judged by the investigator
* Volunteers who have taken a drug with a long half-life (≥ 24 hours) within ten half-lives of the respective drug before enrolment in the study
* Volunteers who received any other drugs which might influence the results of the study during the week prior to the start of the study
* Volunteers who have participated in another study with an investigational drug within the last 2 months preceding this study
* Volunteers who smoke more than 10 cigarettes (or equivalent) per day
* Volunteers who are not able to refrain from smoking on study days
* Volunteers who drink more than 40 g of alcohol per day
* Volunteers who are dependent on drugs
* Volunteers who are participated in excessive physical activities (e.g. competitive sports) during the last week before the study
* Volunteers who have donated blood (≥ 100 ml) within the last four weeks