cyrilzakka/clinical-trials huggingface dataset:
Study of Predictive Biomarkers for Rational Management of Drug-resistant Epilepsy Associated With Focal Cortical Dysplasia

Focal Cortical Dysplasias (FCDs) are neurodevelopmental disorders that represent a major cause of early onset drug-resistant epilepsies with cognitive and behavioral impairments, carrying a lifelong perspective of disability and reduced quality of life. Despite a major medical and socio-economic burden, rationale therapeutic strategies are still under debate. Surgical removal of the epileptogenic brain area (Epileptogenic Zone) is the most successful treatment, yet it fails to control FCD-associated seizures in as much as 40% of cases. Precise definition and complete resection of the Epileptogenic Zone are the main determinants of outcome. In current practice of French centers, up to 80% FCD-patients require an intracranial EEG (icEEG) recording to accurately define the epileptogenic zone. However, the indications for icEEG in MRI-visible FCD remain empirical and are essentially based on expert opinion.


Eligibility Criteria:
Inclusion Criteria:

* Adult or pediatric patient suffering from drug-resistant focal epilepsy;
* Age more than 2 years old;
* Brain MRI suggestive of FCD or normal;
* Standardized presurgical evaluation available including medical history, scalp video-EEG, 3T MRI, FDG-PET, Neuropsychological tests;
* Inpatient in one of the participating centers for recording seizure during long term scalp video-EEG and / or SEEG-monitoring;
* Resective surgery with a minimal post-operative follow-up of 12 months;
* Histopathologic evidence for FCD or non-pathologic findings (normal histology or mMCD type II).
* Patient, parents or legally representative who have given written informed consent to allow the study data collection procedures.

Exclusion Criteria:

* Brain MRI suggestive of another type of lesion;
* Difficulty to read or understand French, or inability to understand the information;
* Pregnant or breastfeeding woman;
* Subject under judicial protection.
* Other lesion discovered on histological examination;
* FCD type 3, dual pathology, ambiguous or unavailable neuropathological findings
* Lack of longitudinal pre- and post-surgical follow-up.
Antithymocyte Globulin as a Second Line Therapy in Graves Orbitopathy

The overall objective of the study is to evaluate the safety and efficacy of rabbit antithymocyte globulin in the treatment of Graves orbitopathy (GO) after ineffective treatment with moderate-to-high doses of glucocorticoids.

This is a prospective interventional, single-center study examining the safety and efficacy of rabbit antithymocyte globulin (rATG) in adult patients with active moderate-to-severe GO after ineffective treatment with moderate-to-high doses of glucocorticoids. All enrolled participants will receive 0.8 - 1.0 mg/kg of rATG (cumulative dose of 150-200 mg given intravenously in two or three divided doses, 24 hours apart) after premedication with methylprednisolone i.v. (in total dose of 375 mg), 1 mg of antihistaminic agent clemastine and 1000 mg paracetamol i.v.

In order to assess efficacy and safety of the treatment, patients will be evaluated at baseline and at 6, 12, 24 and 48 weeks. Baseline and subsequent evaluation will involve medical history, physical examination, including detailed eye examination, laboratory assessment (thyroid-stimulating hormone \[TSH\], flow cytometry, TSH-receptor antibodies, CBC) and orbital magnetic resonance imaging (MRI).

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of Graves' disease associated with active thyroid eye disease and a clinical activity score of ≥ 3
* Euthyroid or with mild hypo- or hyperthyroidism defined as free thyroxine (FT4) and free triiodothyronine (FT3) levels less than 50% above or below the normal limits
* previous ineffective treatment (partial response, recurrence or progression of symptoms) with moderate-to-high doses of glucocorticoids (at least 4.5 g of methylprednisolone)

Exclusion Criteria:

* hypersensitivity to rabbit proteins or to any product excipients
* active acute or chronic infections
* latent tuberculosis
* leucopenia below 3000/μl
* lymphopenia below 400/μl
* thrombocytopenia below 75000/μl
* coagulation disorders
* active malignancy and pregnancy
Interventional Program Educates, Identifies + Overcomes Barriers to Complete Screening Mammography

The purpose of this study is to identify interventions that are designed to better serve women who are homeless, with a speciﬁc focus on increasing screening rates and decreasing late stage breast cancer diagnosis among this high-risk understudied community of women. As a result, the study team hopes to influence the broader homeless healthcare initiative

The goal of this program will be to bring 6-8 mobile on site mammography clinics to homeless shelters that house women over a two-year period. Prior to arrival, clinic staff will recruit women to participate in a survey to elucidate beliefs and barriers around breast health and mammography. After the survey, clinic staff will conduct the outreach program, consisting of a brief educational session about breast health and mammography for any participating women. Education will be tailored to be culturally appropriate, and delivered by a female public health educator with experience in the underserved community. The educational session will explain screening options and address common barriers. After education, eligible women who wish to receive a mammogram may receive one from the on-site mobile mammography clinic free of charge. Throughout the day, the community educator will also lead activities and meals will be provided in order to create a festive atmosphere and inspire a sense of community among the women. Spanish speaking staff will be available for the educational sessions.

Eligibility Criteria:
Inclusion Criteria:

* Women under age 40 who present with high risk breast cancer related symptoms or a first degree relative with breast cancer
* Have not had mammogram in the last 12 months
* Resident at a homeless shelter or transitioning housing facility.

Exclusion Criteria:

- Participant experiencing homelessness under age 40 who DO NOT present with high risk breast cancer related symptoms or a first degree relative with breast cancer.
Study of Heat and Intravenous Fluids for Exogenous Rewarming

The purpose of this study is to compare two novel active rewarming techniques in mildly hypothermic people. Volunteers will undergo 3 cooling trials in a circulating bath at 14 degrees celsius and will then be rewarmed with either shivering alone, warmed iv fluids (IVF), or water perfusion pads applied to the hands and feet. The investigators hypothesize that both heated IVF and water perfusion pads to the arteriovenous anastomoses (AVAs) will prove to provide significantly superior rewarming rates than shivering alone.


Eligibility Criteria:
Inclusion Criteria:

* Any healthy male or female over 18 years of age

Exclusion Criteria:

* No heart/blood pressure/cholesterol medications.
* No history of Raynaud's disease or any other condition (including asthma) that could be aggravated by cold-water immersion
Function Outcome of Impaction Injuries in Acetabular Fractures

Is the anatomical reduction of osteochondral impaction in the acetabular fractures will improve the functional outcome? Despite the increasing amount of literature related to the management of anteromedial dome impactions and marginal impactions, there are still remaining issues and controversies pertaining mainly to the exact anatomy and location of the lesion, the best method of reduction, the need and type of subchondral void filling, the best method of stabilization, the need of reduction in elderly population and its true value as an outcome prognostic factor.

The reduction of the impacted fragment done through many ways and techniques , all acetabular approaches can be used to reach to the impacted part or through independent cortical window, The impacted part can be reached through the fracture itself as in marginal impaction through the posterior wall and in anteromedial impaction through the quadrilateral plate. Then using a bone graft as a void filling which can be taken from iliac bone or greater trochanter. Post-operative x-rays and computed tomography scan will be done to all patients , Radiological grading immediate post-operative and at the last follow-up according to Matta , Heterotopic ossification will be classified according to the Brooker classes on an Anteroposterior radiograph, Posttraumatic arthritis will be evaluated according to the method by Kellgren and Lawrence, functional outcome will be assessed according to Merle D'Aubigne and Postel scoring which was modified by Matta, Avascular necrosis of hips will be classified according to Ficat and Arlet classification.

Eligibility Criteria:
Inclusion Criteria:

* Traumatic Osteochondral impaction injuries of the acetabulum (marginal and dome ).
* Pure impaction without cortical interruption
* Closed fractures.
* Skeletally mature (adults and elderly).

Exclusion Criteria:

* Fractures in skeletally immature patients.
* Pathological fractures .
* Associated proximal Hip fractures.
* Open acetabular Fractures.
* Fractures more than 3 weeks
Chronic Suppurative Otitis Media Microbiology

This study is planned to reveal the microbiological agents and drug sensitivities to these agents in patients diagnosed with chronic suppurative otitis media who complain of ear discharge.

Patients with complaints of ear discharge and who were diagnosed with chronic suppurative otitis media will be included in the study. Patients will be divided into two groups: CSOM with cholesteatoma and CSOM without cholesteatoma. One hundred ten patients from each group will be included in the study. After a comprehensive medical history is taken for each patient, the patient's external auditory canal will be cleaned with sterile aspirators. A sterile culture will be taken from the discharge of the ear and sent to microbiology. With the data obtained from microbiological examination, pathogens will be classified as gram-positive, gram-negative, anaerobic, and fungal and examined according to monomicrobial and polymicrobial growth. Antibiotic susceptibility tests will be conducted to determine the effectiveness of antibiotics against the bacteria causing the infection.

Eligibility Criteria:
Inclusion Criteria:

1. Patients diagnosed with chronic suppurative otitis media
2. Patients over 18 years of age

Exclusion Criteria:

1. Chronic nonsuppurative otitis media patients
2. Patients diagnosed with external ear canal/middle ear malignancy
3. Patients who take immunosuppressive drugs
4. Immunosuppressive patients
5. Patients who used antibiotics (topical-systemic) in the last week
A Study to Evaluate Efficacy and Safety of Methacholine Chloride Challenge Test in Diagnosis of Adult Asthma

The purpose of this study is to evaluate efficacy and safety of Methacholine Chloride challenge test in diagnosis of adult asthma


Eligibility Criteria:
Inclusion Criteria:

* FEV1/forced vital capacity(FVC) must be 70% or more
* \<10% decrease in FEV1 in response to inhalation of normal saline

Exclusion Criteria:

* Moderate airflow limitation (FEV1 \< 60% predicted or \< 1.5 L)
* Heart attack or stroke in last 3 months
* Uncontrolled hypertension, systolic BP\>200, or diastolic BP\>100
Lung Ultrasound in Children With Severe Malaria

A prospective cohort study, with 171 children admitted for severe malaria that will be included in the cohort. The study will take place in Kinshasa, Democratic Republic of Congo.

The primary objective is to evaluate the prevalence of five pre-specified pulmonary diagnoses that can be facilitated by the use of LUS (normal lung or acidotic breathing, ARDS, concomitant pneumonia, hydrostatic pulmonary oedema, pleural effusion).

A prospective cohort study, with 171 children (between 1 - 14 years) admitted for severe malaria that will be included in the cohort. The study will take place at the Maluku District Hospital, located in Kinshasa, Democratic Republic of Congo.

Lung ultrasound will be performed on admission, h24, and unscheduled timepoints (in case of respiratory deterioration during hospital stay). Lung auscultation and peripheral capillary oxygen saturation (SpO2) will be assessed at each time points. All children will be observed from admission to hospital discharge. At 30 days a phone call will be made by the study staff to follow up clinical conditions of the child.

The total duration for each subject's participation in the study is approximately 1 month. The study period is approximately 12 months

Funder: The Wellcome Trust (ITPA grant) WT-iTP-2019/005

Eligibility Criteria:
Inclusion Criteria:

* Children aged between 1 and 14 years;
* Admitted for confirmed severe malaria (i.e. positive peripheral blood slide for malaria parasite and/or positive rapid diagnostic test for malaria in combination with one or more clinical or laboratory severity criteria detailed below).
* Informed consent signed

Clinical features of severe malaria

* Cerebral malaria; A Glasgow Coma Scale of less than 11 or a Blantyre coma scale less than 3 in preverbal children
* Respiratory distress (costal indrawing, use of accessory muscles, nasal flaring, deep breathing or severe tachypnea (respiratory rate \> upper normal limit for age)
* Jaundice (visible jaundice)
* Circulatory collapse or shock: age \<12 systolic blood pressure \< 70mm Hg; age \> 12 systolic blood pressure \<80mm Hg with cool extremities or capillary refill time \>3 seconds
* Spontaneous bleeding
* Multiple generalized convulsions: more than two episodes within 24h
* Prostration, i.e. generalized weakness so that the patient is unable to sit, stand or walk without assistance

Laboratory features and other findings

* Metabolic acidosis (venous plasma bicarbonate \< 15mmol/l or base excess \< -2.2mEq/L)
* Severe anaemia (age \<12: hematocrit \< 15% or haemoglobin \< 5g/dl; age\>12: hematocrit \< 20% or hemoglobin \< 7 g /dl)
* Hypoglycaemia (\< 2.2mmol/l or \< 40mg/dl)
* Hyperparasitaemia defined as \> 10%
* Hyperlactataemia (venous lactate \< 5 mmol/L)
* Kidney dysfunction (blood urea \>20mmol/L)

Exclusion Criteria:

* Co-morbidity which, in the judgement of the investigator or treating physician, would place the subject at undue risk or interfere with the patient's treatment or results of the study. E.g. immediate transfer needed.
Comparison of Treatment Simplification by LPV/r vs Current Treatment Continuation in HIV-Infected Patients

The purpose of this study is to compare the efficacy and tolerance of a treatment simplification by a Lopinavir/ritonavir monotherapy versus continuation of current treatment in HIV-infected patients

Highly active antiretroviral therapy (HAART) has made a significant impact on the natural history of HIV-1 infection, but toxicities and complexities of therapy limit long-term efficacy, and make simpler yet effective HAART regimens highly desirable. Previous attempts to 'de-intensify' protease inhibitor (PI)-based therapy by discontinuing reverse transcriptase inhibitors (RTI) after achieving viral suppression met with failure, probably because plasma levels of most individually administered PI are too low to inhibit viral replication consistently.

Low-dose ritonavir substantially enhances lopinavir plasma levels, and lopinavir/ritonavir (LPV/r) is effective as part of a combination therapy in both naive and PI-experienced patients. Furthermore, lopinavir is known to have a high genetic barrier to selection of resistance. LPV/r monotherapy could thus have the right combination of potency, favorable pharmacokinetics, and high genetic barrier needed to suppress viral replication and prevent the selection of lopinavir resistance. Preliminary results with "maintenance"LPV/r monotherapy show interesting results but data from randomized studies are needed.

Eligibility Criteria:
Inclusion Criteria:

* Age \> or = 18 years
* Confirmed HIV-1 seropositivity
* Antiretroviral treatment stable since 3 months at least
* HIV-1 ARN load \< 50 copies/mL since 6 months at least
* Signed consent form
* No history of treatment failure (= viral load \> 1000 copies/mL) including a protease inhibitor
* No opportunistic infection in the previous 6 months

Exclusion Criteria:

* Neutrophils \< 750/mm3
* Hemoglobin \< 8 g/dL
* Platelets \< 60,000/mm3
* Creatinin \> 150 micromoles/L
* SGOT \> 5 NUL (Normal Upper Limit)
* SGPT \> 5 NUL
* Current IL-2 treatment
* HBV infection treated or not by lamivudine or tenofovir
* Pregnancy or feeding
* Enrollment in another study not compliant with KALESOLO Study group assignment
Patient-Derived Organoids for Rectal Cancer

The purpose of this study is to determine the feasibility of establishing patient-derived organoids from pre-treatment rectal adenocarcinoma biopsies.


Eligibility Criteria:
Inclusion

1. Age ≥18 years old.
2. Able to provide informed consent.
3. Undergoing proctoscopy.

Exclusion

1. Patient not planned to receive neoadjuvant radiotherapy
Determination of Lung Maturity and Prediction of RDS at Birth

The overall objective is to identify quickly after birth the preterm infants who will develop respiratory distress syndrome (RDS) for the purpose of treating them as early as possible with surfactant, to reduce, and if possible, to avoid sequelae, including long-term oxygen treatment.

We have therefore developed a quick test, which we believe will be ideal for this type of diagnostics, and will now test the method in a preclinical trial.

In at least 135 preterm infants with gestational age 24-32 weeks we will collect gastric aspirate and hypopharyngeal secretion. The infants are stratified into three groups: gestational age 24-25 weeks, 26-29 weeks and 30-31 weeks.

The aspirates will be frozen at -20 centigrade and lecithin-sphingomyelin ratio (L/S) will be analysed retrospectively using Fourier Transform Infrared Spectroscopy.

The infants will be monitored for the first five days with regard to possible development of RDS.

Clinical and biochemical data will be compared retrospectively.

There a no intervention procedures.

Eligibility Criteria:
Inclusion Criteria:

* Preterm infants with gestational ages of 24 (24+0) to 32 (31+6) weeks.
* Age \< ½ hour

Exclusion Criteria:

* Lack of informed consent
* lack of aspirate
The Safety and Pharmacokinetics of Intraperitoneal Administration in Patients Undergoing Appendectomy for Uncomplicated Appendicitis

The objective of this trial is to evaluate the safety of the intraperitoneal administration of the combination of fosfomycin, metronidazole, and granulocyte-macrophage colony-stimulating factor (GM-CSF) in patients undergoing surgery for uncomplicated appendicitis. Further, in a sub-trial the aim is to investigate the plasma concentrations of fosfomycin and metronidazole after intraperitoneal administration.


Eligibility Criteria:
Inclusion Criteria:

* Men ≥18 years old
* Suspicion of acute appendicitis and planned for diagnostic laparoscopy and eventual appendectomy
* Written informed consent after written and verbal information

Exclusion Criteria:

* Cannot understand, read or speak Danish
* Previous allergic reaction to fosfomycin, metronidazole, or GM-CSF
* Perforated appendicitis (diagnosed either during surgery or at a preoperative computer tomography (CT) scan)
* Diagnostic laparoscopy revealing normal appendix not requiring an appendectomy
* Other intra-abdominal pathology requiring surgical intervention (diagnosed either during surgery or at a preoperative CT-scan)
* Known renal or hepatic disease or biochemical evidence at the time of admission
* Known autoimmune disease or other chronic inflammation
* Known hematologic disease or cancer
* Previous abdominal surgery (either laparoscopic or open surgery)
* Daily use or use of medication one week prior to or during the trial period apart from painkillers such as paracetamol, ibuprofen, tramadol, and morphine as well as drugs needed for anaesthesia, thrombosis prophylaxis, and nausea. Limitations for antibiotics are defined below
* Use of other antimicrobial agents than the trial treatment one month before until 24 hours after the trial treatment
* Participant in another drug trial one month prior to the date of the surgery
* Body mass index ≥35 kg/m2
* Weekly intake of alcohol \>14 units, where one unit corresponds to 12 g alcohol
Tongue Root Retractor For Fibroscopic Intubation

Patients admit to the operation rooms of First Affiliated Hospital of Nanjing Medical University and requiring endotracheal intubation for general anesthesia will be enrolled in this case controlled study.

Patients 1) aged 18 to 70 years; 2) ASA graded I\~II class; 3) general anesthesia should be performed under endotracheal intubation, will be included from this study. Patients 1) with organ transplant operations; 2) with thoracic and cardiac vascular surgery; 3) with severe heart or lung disease; 4) BMI over 35kg/m2, will be excluded from this study.

The primary aim is to compare airway clearance for fibreoptic tracheal intubation in each patient position. Secondary outcomes include times to view the vocal cord and carina, the time for tube advancement through the vocal cords, as well as the total time to achieve tracheal intubation.Two anesthesiologists with 5 years of experience in conventional endotracheal intubation and trained for fibreoptic intubation will perform the maneuvers.


Eligibility Criteria:
Inclusion Criteria:

* aged 18 to 70 years
* ASA graded I\~II class
* scheduled for elective surgery requiring orotracheal intubation

Exclusion Criteria:

* with organ transplant operations
* with thoracic and cardiac vascular surgery
* with severe cadiac or pulmonary disease
* BMI over 35kg/m2