cyrilzakka/clinical-trials huggingface dataset:
Febrile Illness in Kinshasa and Kimpese

This is a bi-centric prospective observational cohort study of adults and children presenting to the emergency room or outpatient department with community febrile illness (with or without signs of focalization) in 2 clinical sites (hospitals) in the DRC. The study will describe the epidemiology, clinical aspects, severity, management and outcome of febrile illnesses using data collected during routine diagnostic and therapeutic procedures.

Each patient will be followed for 21 days. The follow-up will include

* Daily visits for hospitalized patients,
* Telephone calls (or study center visit or home visit) on days 7, 14 and 21 for outpatients and discharged patients.

The study has been amended (EC UZA approval in June 2021) to perform a set of laboratory analyses in the partners institutions and at the ITM. We aim as a new primary objective at describing the profile of different biomarkers (C-reactive protein and white blood cell count with differentiation) in participants enrolled with febrile illness, and as secondary objectives to correlate them with outcome (assessed at day 21) and with several etiological diagnoses, especially malaria (as assessed by rapid diagnostic test and blood smear). The purpose is to investigate the potential diagnostic and prognostic value of these biomarkers which are increasingly available at the point-of-care.


Eligibility Criteria:
Inclusion Criteria:

1. Ongoing and objectified fever at presentation, or documented at home or other health center within 24 hours prior to presentation, defined by:

   * Axillary or tympanic temperature \> 37.5°C OR
   * Oral or rectal temperature \> 38°C
2. Possibility of contact between the patient (or designated relative) and the study team on days 7, 14 and 21
3. Informed consent signed by the patient (adults) or a legally acceptable representative (children or patients whose condition does not allow them to sign informed consent), with the consent of children as young as 12 years of age, whenever possible.

Exclusion Criteria:

1. Children less than two months old
2. Hospitalization \> 48 h in the last 14 days (to exclude nosocomial fevers)
Cognitive Behaviour Therapy for Sleep Problems in Children With Autism Spectrum Disorder

Sleep disturbance is very common in children with autism spectrum disorder (ASD),and closely associated with their core symptom, social deficit.This trial investigates the effects of Cognitive behaviour therapy for insomnia (CBT-I) in children with autism spectrum disorder with sleep problems through synchronized eye-tracking and functional near-infrared spectroscopy (fNIRS). This is a 1:1 parallel single-blind randomized controlled trial.

sleep disturbance is significantly associated with social deficit of ASD and but the congnitive-neural mechanism underlying this association remains unclear. Cognitive behaviour therapy for insomnia (iCBT-I) is considered as an evidence-based treatment for insomnia. After 5 consecutive sleep interventions is a 2-year following up study, the above issue is further tested with emphasis on progressive trajectory from a developmental perspective. we examine the influence of sleep disturbance on face processing and neural response during naturalistic social behavior of ASD children using synchronized eye-tracking and functional near-infrared spectroscopy (fNIRS) to uncover the neural mechanism for that sleep disturbance influences social deficit.

Eligibility Criteria:
Inclusion Criteria:

1. meet the diagnostic criteria for autism DSM-5 and ADOS-2;
2. age 24months to 59months s old;
3. willing to participate in this study, and can complete the following assessments at the specific time.

Exclusion Criteria:

Exclusion of severe respiratory diseases, schizophrenia, epilepsy and other brain diseases;
A Study of LCAR-HL30 in Subjects With Relapsed/Refractory Hodgkin's Lymphoma and Anaplastic Large Cell Lymphoma

This is a prospective, single-arm, open-label, exploratory clinical study of LCAR-HL30 in adult subjects with relapsed/refractory Hodgkin's Lymphoma and Anaplastic Large Cell Lymphoma.

This is a prospective, single-arm, open-label exploratory clinical study to evaluate the safety, tolerability, pharmacokinetics and anti-tumor efficacy profiles of LCAR-HL30, a chimeric antigen receptor(CAR)-T cell therapy in subjects with relapsed/refractory Hodgkin's Lymphoma and Anaplastic Large Cell Lymphoma. Patients who meet the eligibility criteria will receive LCAR-HL30 infusion. The study will include the following sequential stages: screening, pre-treatment (cell product preparation: lymphodepleting chemotherapy), treatment and follow-up.

Eligibility Criteria:
Inclusion Criteria:

1. Subjects voluntarily participate in clinical research.
2. Aged 18 to 75 years, either sex.
3. Eastern Cooperative Oncology Group (ECOG) score 0-1 (Dose escalation phase). ECOG score 0-2 (Dose expansion period).
4. Histologically confirmed Hodgkin's lymphoma or Anaplastic large cell lymphoma with positive CD30 expression.
5. At least one evaluable tumor lesion according to Lugano 2014 criteria.
6. Expected survival ≥3 months.
7. Clinical laboratory values in the screening period meet criteria.
8. Effective contraception.

Exclusion Criteria:

1. Prior antitumor therapy with insufficient washout period.
2. Previous treatment with CAR-T therapy, allogeneic hematopoietic stem cell transplantation.
3. Severe underlying diseases;
4. Hepatitis B virus surface antigen (HbsAg), Hepatitis B virus deoxyribonucleic acid (HBV DNA), hepatitis C virus ribonucleic acid (HCV RNA) or human immunodeficiency virus antibody (HIV-Ab) positive.
5. Presence of other serious pre-existing medical conditions that may limit patient participation in the study. Any condition that, in the investigator's judgment, will make the subject unsuitable for participation in this study.
A Prospective, Multi-Center, Pivotal Study to Evaluate the Safety and Effectiveness of the NovaCross™ Micro-catheter in Facilitating Crossing Chronic Total Occlusion (CTO) Coronary Lesions

This study evaluates the safety and effectiveness of the a novel device called NovaCross to help cross Chronic Total Occlusion (CTO) lesions in coronary arteries.

The purpose of this trial is to evaluate the safety and effectiveness of the NovaCross™ micro-catheter when used to facilitate crossing of Chronic Total Occlusion (CTO) lesions in coronary arteries. The procedure will be conducted on consenting patients diagnosed with a CTO in a coronary vessel that requires revascularization after a previously failed attempt to cross or refractory to 10 minutes of conventional guidewire attempt.

Eligibility Criteria:
Inclusion Criteria:

* Adult aged 25-80
* Patient understands and has signed the study informed consent form.
* Patient has an angiographic documented Chronic Total Occlusion (i.e. \>3 months occlusion duration) showing distal TIMI flow 0.
* Suitable candidate for non-emergent, coronary angioplasty
* Documented coronary angiography preceding the PCI reveals at least one CTO lesion situated in a non-infarct related coronary artery or its side branches
* Body Mass Index (BMI) \< 40
* Left ventricle ejection fraction \> 25%

Exclusion Criteria:

* Patient unable to give informed consent.
* Current participation in another study with any investigational drug or device.
* Patient is known or suspected not to tolerate the contrast agent.
* Aorta-ostial CTO location (Ostial bifurcation origins may be considered), SVG CTO, in-stent CTO.
* Intolerance to Aspirin and/or inability to tolerate a second antiplatelet agent (Clopidogrel and Prasugrel and Ticagrelor).
* Appearance of a fresh thrombus or intraluminal filling defects.
* Recent major cerebrovascular event (history of stroke or TIA within 1 month)
* Cardiac intervention within 4 weeks of the procedure
* Renal insufficiency (serum creatinine of \> 2.3mg/dl or 203μmol/L)
* Active gastrointestinal bleeding
* Active infection or fever that may be due to infection
* Life expectancy \< 2 years due to other illnesses
* Significant anemia (hemoglobin \< 8.0 mg / dl)
* Severe uncontrolled systemic hypertension (\> 240 mmHg within 1 month of procedure)
* Severe electrolyte imbalance
* Congestive heart failure \[New York Heart Association (NYHA) Class III\\IV\] CSA Class IV.
* Unstable angina requiring emergent percutaneous trans-luminal coronary angioplasty (PTCA) or coronary artery bypass graft (CABG)
* Recent myocardial infarction (MI) (within the past two weeks)
* Uncontrolled diabetes \>2 serum glucose concentrations of \>350 mg/dl within 7 days.
* Unwillingness or inability to comply with any protocol requirements
* Pregnant or nursing
* Extensive prior dissection from a coronary guidewire use
* Drug abuse or alcoholism.
* Patients under custodial care.
* Bleeding diathesis or coagulation disorder;
* Kawasaki's disease or other vasculitis
A Study to Assess the Efficacy of XEN-D0501 in Reducing the Cough Frequency in Patients With Chronic Idiopathic Cough

The purpose of this study is to determine the effectiveness of XEN-D0501 over placebo in reducing the daytime cough frequency in patients with chronic idiopathic cough.

The effectiveness of XEN-D0501 over placebo in reducing capsaicin cough responses, objective 24-hour cough frequency, hourly change in cough frequency, cough severity (via visual analogue scale \[VAS\]), urge to cough (via VAS), global rating of change scale and Leicester Cough Questionnaire (LCQ) will be evaluated.


Eligibility Criteria:
Inclusion Criteria:

* Male/female subjects aged 18 or over with chronic idiopathic cough

Exclusion Criteria:

* Clinically significant medical history
* Abnormal laboratory results, ECGs or vital signs
Optimizing Care for Challenging People Living With HIV

Conduct an intervention combining social and behavioral health models with digital health technologies to improve their adherence to their medication schedules. The success of the intervention is assessed by comparing adherence rates before and after its implementation to see if there's a notable enhancement in how well patients follow their antiretroviral therapy.

This is an intervention strategy for HIV-infected individuals based on their viral load measurements and medication adherence rates, measured by the proportion of days covered (PDC) for the past 365 days. A specific PDC threshold identifies individuals with less than 90% viral suppression at under 200 copies/mL. An intervention approach integrating social and behavioral models with electronic health (eHealth) technology is implemented for cases with a PDC below this threshold. The intervention aims to enhance the patient's adherence to their medication regimen. The effectiveness of this intervention is evaluated by comparing indicators before and after its application to determine if there are significant improvements in the participants' compliance with their antiretroviral therapy.

Eligibility Criteria:
Inclusion Criteria:

1. PLWH with adherence below the specific proportion of days covered (PDC), which is defined as the specific level that corresponds to 90% at viral suppression (\< 200 copies/mL).

Exclusion Criteria:

1. Under 18 years of age.
2. Illiterate.
3. Non-consenting individuals.
4. Less than 365 days from the initial use of antiretroviral drugs to the assessment for inclusion in the study.
5. Inability to obtain complete medication records for the 365 days prior to inclusion.
6. Lack of a smart phone.
7. No willingness to return for follow-up at the participating hospital.
Clinical and Molecular Characterization of Familial Microsatellite Stable Colorectal Cancer

Two major genetic pathways leading to colorectal carcinoma can well be distinguished; the 'suppressor pathway', which is characterized by inactivation of tumor-suppressor genes and the 'mutator pathway', which is characterized by microsatellite instability. The purpose of this study is to explore a third putative pathway; microsatellite and chromosome stable colorectal cancer where an alternative cancer-causative mechanism might play a role.

Patients with familial colorectal cancer will be characterized with respect to family history, medical history and demographic characteristics. The histopathology of the tumors will be reviewed. Tumor specimens will be analysed on molecular defects.

Eligibility Criteria:
Inclusion Criteria:

- Colorectal cancer before the age of 51 years

Microsatellite stable tumor

Exclusion Criteria:

-
Microneedling Plus the Universal Peel For Acne Scarring

Acne is a prevalent disorder mostly witnessed in adolescents, but can be seen in adults. Early treatment is imperative to reduce acne scarring which can appear with atrophic lesions, and depending on the skin type, significant erythema (redness) or post-inflammatory hyperpigmentation. A multi-modality approach to treatment is necessary when dealing with the aforementioned types of lesions. Pharmacologic management is essential, but safe procedural therapies are also necessary specifically with darker skinned individuals.

Percutaneous collagen induction therapy (PCIT) is a non-invasive treatment achieved by using a micro-needling device, which is safe and effective in causing "micro-wounds" into the dermis thereby initiating wound healing followed by collagen production. This is an ideal treatment for acne scarring, re-texturizing of the skin, and hyperpigmentation for all skin types . Currently there are very few studies evaluating the safety and efficacy of microneedling and chemical peels in skin types III-VI.

The aim of this study is to evaluate the effects of the combination of microneedling and chemical peel for the treatment of acne scars in skin types III-VI.


Eligibility Criteria:
Inclusion Criteria:

* Subject \> 18 and \< 60 years of age.
* Subject has skin type III, IV, V, or VI as defined by the Fitzpatrick Classification Scale.
* Subject has acne scarring as defined by the Goodman and Baron Grading System.

Exclusion Criteria:

* Subject currently has moderate to severe acne on the face.
* Subject has an active infection.
* Subject is pregnant or lactating.
* Subject has a history of a bleeding disorder.
* Subject is taking an anti-coagulant.
* Subject has a history of keloidal tendency.
* Subject has received ablative or non-ablative laser treatments in the previous 6 months.
* Subject has taken Accutane within the previous 3 months.
Comparison of Adaptive Dose Painting by Numbers With Standard Radiotherapy for Head and Neck Cancer.

The investigators hypothesize that treatment adaptation to biological and anatomical changes, occurring during treatment, can increase the chance of cure at minimized or equal radiation-induced toxicity in head and neck cancer patients. This trial compares standard intensity-modulated radiotherapy (IMRT), using only pre-treatment planning 18F-2-fluoro-2-deoxy-D-glucose positron emission tomography to adaptive 18F-2-fluoro-2-deoxy-D-glucose positron emission tomography voxel intensity based IMRT or volumetric-modulated arc therapy (VMAT) using repetitive per-treatment planning 18F-2-fluoro-2-deoxy-D-glucose positron emission tomography for head and neck cancer.


Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed squamous cell carcinoma of oral cavity, oropharynx, hypopharynx or larynx
* Primary unresectable tumor and/or patients that refused surgery
* Stages T1-4; T3-4 N0 or T(any) N1-3 for glottic cancer
* Multidisciplinary decision of curative radiotherapy or radiochemotherapy
* Karnofsky performance status \>= 70 %
* Age \>= 18 years old
* Informed consent obtained, signed and dated before specific protocol procedures

Exclusion Criteria:

* High risk Human Papilloma Virus (HPV)
* Treatment combined with brachytherapy
* Prior irradiation to the head and neck region
* History of prior malignancies, except for cured non-melanoma skin cancer, curatively treated in-situ carcinoma of the cervix or other cancer curatively treated and with no evidence of disease for at least 5 years.
* Distant metastases
* Pregnant or lactating women
* Creatinine clearance (Cockcroft-Gault) =\< 60 mL/min
* Mental condition rendering the patient unable to understand the nature, scope and possible consequences of the study
* Patient unlikely to comply with protocol, i.e. uncooperative attitude, inability to return for follow-up visits, and unlikely to complete the study.
Effect of Variance on Error Correction During Coupling

This study is a case-control study, involving persons with progressive multiple sclerosis and healthy controls. The study contains 1 descriptive and 3 experimental sessions. In the descriptive session, participant's clinical motor and cognitive functions are collected. In the first experimental session, participant's beat perception and synchronisation abilities is examined within a finger tapping paradigm. In the following experimental sessions participants synchronsiation abilities is examined during walking paradigms, to music and metronomes, with period and phase auditory manipulations. In the latter twp sessions, apart from outcome measures of synchronization the following will be collected as well: brain activity using EEG recordings, spatio-temporal gait parameters, perceived fatigue, perceived motivation and perceived speed of walking.


Eligibility Criteria:
Inclusion Criteria:

* diagnosis of Multiple sclerosis \>1 year, diagnosis of progressive MS,
* walking speed 0.8-1.2m/s, ability to walk for 6 minutes continuously (canes and rollators are permitted)

Exclusion Criteria:

* relapse 3 months prior to enrollment,
* cognitive impairment impeding understanding of instructions,
* beat amusia,
* deafness,
* pregnancy
A Phase II Clinical Trial to Evaluate HLX208 in Advanced Solid Tumor Patients With BRAF V600 Mutation

An Open-label, Multicenter Phase II Clinical Study to Evaluate Safety, Efficacy and PK of HLX208 (BRAF V600E Inhibitor) in Advanced Solid Tumor With BRAF V600 Mutation


Eligibility Criteria:
Inclusion Criteria:

* Age\>=18Y
* Good Organ Function
* Expected survival time ≥ 3 months
* advanced solid tumors with BRAF V600 mutation that have been diagnosed
* Previous failure to standard treatment, absence of standard treatment, or insuitability for standard treatment at this stage.
* ECOG score 0-1;

Exclusion Criteria:

* Previous treatment with BRAF inhibitors or MEK inhibitors
* Symptomatic brain or meningeal metastases (unless the patient has beenon \> treatment for 6 months, has no evidence of progress on imagingwithin 4 weeks prior to initial administration, and tumor-related clinical symptoms are stable)
* A history of other malignancies within two years, except for cured carcinoma in situ of the cervix or basal cell carcinoma of the skin
* Patient with non-small cell lung cancer, anaplastic thyroid cancer, malignant primary intracranial tumor, melanoma, colorectal cancer or hematological tumor（Vulva and vaginal melanoma are excluded.）
* Severe active infections requiring systemic anti-infective therapy
Transcranial Direct Current Stimulation for Post-stroke Fatigue

The investigators hypothesize that delivery of anodal tDCS to the left frontal head region will reduce fatigue severity following stroke.

The purpose of this study is to investigate transcranial direct current stimulation (tDCS) as a home-based non-pharmacologic intervention for post-stroke fatigue (PSF). Investigators will perform a double-blind, sham-controlled, randomized clinical trial with 24 subjects; 12 will receive sham stimulation and 12 will receive real stimulation. After a baseline assessment, the tDCS device will be applied for 20 minutes, once daily over the left dorsolateral prefrontal cortex (DLPFC), for a total of two weeks. Follow-up assessments with outcome metrics will be completed after the seventh and fourteenth sessions, and one-month following the start date (2 weeks post-treatment). Neuroimaging will be completed at baseline and post-treatment.

Eligibility Criteria:
Inclusion Criteria:

* Male or female patients aged \>18 years
* Greater than 3 months from first hemorrhagic or ischemic stroke (subacute to chronic), confirmed through neuroimaging (CT or MRI).
* Fatigue severity score average \>4 (severe fatigue)
* Willingness to remain stable on pharmacologic therapy through the duration of the study.
* Availability of a caregiver, family member, or friend to be present during the administration of the tDCS intervention.

Exclusion Criteria:

* Metal in the head (except mouth) or implanted cranial or thoracic devices (i.e. pacemaker, DBS stimulator)
* History of seizure
* History of moderate to severe traumatic brain injury
* A score of 10 or more on the PHQ-9 or GAD-7 scale, suggestive of moderate to severe depression/anxiety.
* A score of less than 21 on the MoCA suggesting major neurocognitive disorder.
* Signs of skin rash, infection, or laceration in the supraorbital region where the tDCS will be applied.
* Inability to provide informed consent
* Other major neurological, medical, or psychiatric illnesses that could confound results in the opinion of the site investigator.
Uses of CMR in Detection of Left Atrial Thrombus

The incidence of rheumatic heart diseases have not declined in our population .Rheumatic heart diseases, often neglected by media and policy makers, is a major burden in developing countries where it causes most of the cardiovascular morbidity and mortality in young people, leading to about 250000 deaths per year worldwide. Mitralstenosis is one of the most common complications of rheumatic heart diseases in our community. A treatment of choice in suitable cases is percutaneous Mitral Commissurotomy .Preoperative evaluation for Percutaneous Mitral Commissurotomy typically requires trans-esophageal echocardiogram (TEE) for the presence of LA thrombus. TEE is currently considered the gold standard for LA thrombus detection given its favorable sensitivity and specificity . With recent advances,CMRis now becoming another reliable diagnostic method for evaluation of thrombus in the left atrium, particularly when delayed imaging is performed.

Whereas TEE is a semi-invasive procedure, CMRis totally non-invasive . Effectiveness of left ventricular thrombus detection by CMR has been validated, and it is now becoming a preferred imaging modality for evaluation of left ventricular thrombus . Moreover, in patients undergoing pulmonary vein isolation,Cardiac Magnetic Resonance was validated against TEE for LA \& left atrial appendage . To our knowledge, there are few data regarding the utility of Cardiac Magnetic Resonance for detection of LA thrombus in patients undergoing Percutaneous Mitral Commissurotomy.

Patients with Mitral stenosis that admitted in Assiut University hospital -Cardiovascular Department for doing Percutaneous Mitral Commissurotomy Will undergo Trans-esophageal echo and Cardiac Magnetic Resonance for detection of left atrial Thrombus and left atrial appendage thrombus. Investigators will compare the result of Cardiac Magnetic Resonance with the results of Trans-esophageal echo for seen the sensitivity and specificity of Cardiac Magnetic Resonance in compare to Trans-esophageal echo who is the gold standard imaging for detection of left atrial and left atrial appendage Thrombus.Data will be presented as mean ± standard deviation for continuous variables and frequency for categorical variables.

* Patients with and without thrombus will be compared using independent (unpaired) Student t test for continuous variables and the Fisher exact test for categorical variables, or their non-parametric equivalents, after testing the data for normality.
* Diagnostic performance of each CMR component will be calculated in the standard manner.

Eligibility Criteria:
Inclusion Criteria:

* Severe mitral stenosis .
* Significant dyspnea.
* Favorable anatomical characteristics for Percutaneous Mitral Commissurotomy as assessed by trans-thoracic echo.

Exclusion criteria:

* Critically ill patients including hemo-dynamically unstable patient.
* Implanted pacemakers/cardiac defibrillators and other electronic implants.
* Cerebral aneurysm clips.
* Pregnancy.
* Significant renal impairment