cyrilzakka/clinical-trials huggingface dataset:
Health-related Quality of Life After Massive Burn Injury

Massive burns are serious life-threatening conditions. Recent advances in their management now allow the survival of a growing number of patients. The burn care paradigm is transformed: the evaluation of survival at the end of acute care is no longer sufficient for a good evaluation of practices; the attention now focuses on long-term health-related quality of life (HR-QOL).The recently validated French translation of the burn specific health scale brief version makes this evaluation now feasible in French burn centers. The objectives of this study are to evaluate the HR-QOL of massive burn survivors, to compare it to another chronic condition (necrotizing fasciitis) and to determine the main predictive factor of health-related quality of life. This study is retrospectively conducted in 18 patients who survived a massive burn injury involving more than 80% of the total body surface area, or more than 70% of the total body surface area if the injury occured during childhood and who were treated between 1997 and 2017 in our Lyon burn center. Short Form-36 Medical Outcomes Survey (SF-36), and Brief Version of Burn Speciﬁc Health Scale (BSHS-B) are used for the present evaluation.

The hypotheses are as follows:

* the HR-QOL of massive burns shows a significative alteration compared to general population
* this alteration is comparable with another chronic disease
* the main predictors of impaired quality of life related to physical health status are hand injury, age at time of burn and time since burn
* the main predictive factors of change in quality of life related to mental health status are age of onset and facial involvement.

Eligibility Criteria:
Inclusion Criteria:

1. Patients over 14 years of age
2. Patients with a childhood burn reaching more than 70% of the total body surface OR Adult patients with burns of more than 80% of total body surface area
3. Patients who were treated at the burn center between January 1997 and January 2017
4. Patients who survived after initial hospitalization for burn management

Exclusion Criteria:

1. Patients with superficial burning, without sequelae or with extensive sequelae at less than 70% of total body surface area in children and less than 80% of total body surface area in adults
2. Patients who expressed opposition to their participation in the study
Study of Compound Edaravone Injection for Treatment of Acute Ischemic Stroke

The primary objective of the study is to confirm the efficacy of compound Edaravone Injection via intravenous infusion every 12 hours in the patients with Acute Ischemic Stroke(AIS) in a double-blind, active-controlled manner. The study is also to examine the safety of compound Edaravone Injection for the AIS patients.


Eligibility Criteria:
Inclusion Criteria:

* Hospitalized patients, diagnosed of ischemic stroke;
* Onset of stroke is less than or equal to 48 hours;
* There are clear signs of neurological deficit: 4≤NIHSS score≤24, and also, the sum of NIHSS score for the upper limb and the lower limb is greater than or equal to 2;
* Patients signed written inform consent

Exclusion Criteria:

* Cranial CT scan finds intracranial bleeding disorders: hemorrhagic stroke, epidural hematoma, intracranial hematoma, intraventricular hemorrhage, subarachnoid hemorrhage;
* Iatrogenic stroke;
* Severe disturbance of consciousness: NIHSS category 1a for consciousness is greater than 1；
* The mRS score prior to this onset is greater than 1;
* Transient ischemic attack (TIA);
* SBP after blood pressure control is still greater than or equal to 220 mmHg, or DBP after blood pressure control is still greater than or equal to 120 mmHg;
* Patients with severe mental disorders and dementia;
* ALT or AST is greater than 2.0×ULN or previously known liver diseases, such as acute hepatitis, chronic active hepatitis, liver cirrhosis;
* Serum Creatinine (SCr) is greater than 1.5×ULN, Creatinine Clearance (CrCl) is less than 50 ml/min or previously known severe renal diseases;
* Therapeutic neuroprotective agents have been applied after onset of stroke, including commercially available edaravone, nimodipine, ganglioside, citicoline, piracetam, butyl benzene peptides, Urinary Kallidinogenase;
* Arterial or venous thrombolytic therapy has been applied after onset of stroke;
* Patients with malignant tumors or receiving concurrent antitumor treatment;
* Patients with severe systemic disease, life expectancy is less than 90 days;
* allergic to edaravone , (+)-Borneol or related excipients;
* Pregnant or lactating women;
* Have major surgery within 4 weeks before enrollment;
* Participated in other clinical studies within 30 days before randomization; or participating in other clinical trials at present;
* The investigators consider the patients are not suitable for this trial.
Cultivating Well-being in Severe Psychiatric Conditions

The multicomponet psychological intervention is called Feliz-Mente, with third generation therapy components that aims to improve wellbeing and self-enhancement. Without intervening directly on the symptoms, it is expected to increase positive experiences, the use of personal strengths and positive relationships, and aims to build a more meaningful self-narrative in persons with severe psychiatric conditions. Feliz-Mente is a group intervention of 12 sessions in which participants are expected to perform exercises during and between sessions to improve treatment adherence and daily practice. The design for the present study is a randomized controlled trial, which compares the post-intervention measures of the experimental group (group receiving the intervention) with the post-intervention measures of the control group (treatment as usual + waiting list).


Eligibility Criteria:
Inclusion Criteria:

* 1) were aged 18-65 years
* 2) had a minimum of motivation and commitment to participate in group therapy

Exclusion Criteria:

* 1) limited cognitive resources or serious formal thinking disorder and/or
* 2) a concurrent diagnosis of substance dependence or a severe personality disorder that could interfere with benefiting from a psychotherapy group.
Transcutaneous Electroacupuncture for Gastric Complications of Scleroderma

An innovative method of needleless transcutaneous electroacupuncture (TEA) using a newly developed watch-size stimulator is proposed. Weak electrical current will be delivered via skin surface electrodes to acupuncture points related to gastrointestinal functions. The stimulator can be attached to the skin near the acupuncture points and therefore daily activity of the patient does not need to be altered. Two experiments are designed to prove the feasibility of the proposed therapy for gastric complications of Scleroderma .


Eligibility Criteria:
Inclusion Criteria:

* No any systemic diseases;
* no scleroderma; no history of gastrointestinal surgery;
* no dyspeptic symptoms during the past 2 weeks;
* not taking any medications except contraceptives during the past 2 weeks;
* age 18 and older.

Exclusion Criteria:

* History of any systemic diseases or surgeries;
* allergic to adhesives; pregnancy;
* unable to sign the consent form.
Pharmacokinetics of Resveratrol Comprising Products

This study was designed to assess the pharmacokinetics of 2 doses of Red Grape Cells (RGC) containing resveratrol compared with a reference. RGC will be administered as single oral dose to fasting healthy volunteers. Plasma concentration of free resveratrol and total conjugates will be analyzed.


Eligibility Criteria:
Inclusion Criteria:

* Ages 18-55 years;
* BMI \>/= 19 and \</= 30
* non smoking
* without history or evidence of significant cardiovascular, hepatic, renal, respiratory, gastrointestinal disease
* normal physical and laboratory examinations

Exclusion Criteria:

* History or evidence of alcohol or drug abuse
* subjects receiving chronic medication
* unusual dietary habits or a recent change in body weight
* acute medical situation 48 hours prior to initiation of the study
* poor venous access
* Subjects participated in a trial or donated blood within 4 weeks before initiation of the study
CKD-391 Pharmacokinetic Study

A randomized, open-label, 2-way crossover study to compare the pharmacokinetics and safety CKD-391 to coadministration Atorvastatin and Ezetimibe in health volunteers.

To compare the CKD-391 (Experimental product) to the dose Atorvastatin calcium and Ezetimibe combination in health male subjects is the purpose of this trial.

Following are evaluated in this trial; Characteristics and safety/Tolerability Of CKD-391.

Eligibility Criteria:
Inclusion Criteria:

* Bwt \>=50kg, BMI 18\~29
* signed the informed consent form prior to the study participation

Exclusion Criteria:

* Clinically significant disease
* Subject has signs of symptoms of acute disease within 28 days of starting administration of investigational drug
* Clinically significant allergic disease
* Impossible to taking the institutional standard meal
* Previously donate whole blood within 60 days or component blood within 20 days
* Previously participated in other trial within 90 days
* Continued to be taking caffeine (caffeine \> 5 cup/day), drinking(alcohol \> 30 g/day) or cannot stop drinking or severe heavy smoker(cigarette \> 10 cigarettes per day)during clinical trials
* An impossible one who participates in clinical trial by investigator's decision including laboratory test result
Metacognitive Intervention in Youth With Oncological Disease - the Mio Study

The aim of the Mio-Study is to address the current lack of effective treatment options to reduce cognitive and physical long-term problems in adolescents with cancer. Through the use of the Mio-App, cognitive and physical development will be strengthened and metacognitive thinking and awareness will increase.

The Mio-App for adolescence with cancer will include a combination of cognitive and physical training tasks and prospective as well as retrospective metacognitive questions. In a randomized controlled trial, the App will be analysed for its efficacy on metacognitive thinking and executive functions. In particular, the investigators are interested in factors that affect the efficacy of the training program such as compliance, age, sex or the presence of fatigue. This study will give insight into the role of metacognition in cognitive and physical performance and will foster the development of adolescents with cancer in the long-term.

In the Mio-Study, the investigators are developing a training app at the interface between neuropsychology and sports science - the Mio-training. The aim of the Mio-training is to strengthen the cognitive and motor development of adolescents after cancer in the long-term. The App contains a combination of cognitive and physical training tasks and metacognitive questions to promote knowledge and awareness of one's own thinking. In order to counteract the shortage of skilled workers and the increasing specialization of individual specialist areas, solutions are needed that can be implemented without a lot of staff. From today's perspective, there are hardly any trainings for adolescents that show long-term effects on cognitive and motor development and can also be transferred to non-trained tasks in school and everyday life.

The investigators are testing the effectiveness of the Mio-training in a randomized clinical trial (RCT) and expect a strengthening of metacognition and core cognitive functions (i.e. executive functions). The Mio-Study will provide information about the role of metacognition in cognitive and physical performance and, ideally, provide evidence for a novel, interdisciplinary rehabilitation strategy for adolescents after cancer.

Eligibility Criteria:
Inclusion Criteria:

* Informed consent as documented by signature (see Informed Consent Form) of participants and / or parents / legal guardians
* Age 10-16 years
* A diagnosis of cancer either with or without central nervous system (CNS) involvement
* Treatment of cancer including either radiation, chemotherapy and/ or surgical tumor removal
* Three months before to three months after the end of cancer treatment
* German or French speaking

Exclusion Criteria:

* Any other instable neurological condition (e.g. epilepsy)
* A severe psychiatric disease (e.g., eating disorder) or severe learning disability
* Known or suspected non-compliance
* Drug or alcohol abuse
* Inability to follow the procedures of the study, e.g. due to language problems
* Enrolment of the investigator, his/her family members, employees and other dependent persons
Analysis of Motor Performance in Children with Duchene's Muscular Dystrophy

25 boys, ages ranging from 6 to 16 years, diagnosed with Duchene's muscular Dystrophy (DMD) will participated in the study. They will be selected from the Pediatric Rehabilitation Center of Deraya University's outpatient clinic in El-Minia district, Minia-Egypt. The outcome will be assessed motor performance will be assed by Bruininks-Oseretsky Test of Motor Proficiency Second Edition (BOT™-2) : balance, running speed and agility, bilateral coordination and strength and by Blue Cherry; Geratherm Respiratory. It is used to measure vital capacity (VC), forced expired volume in one second (FEV1), FEV1/FVC, FEV1/VC, and peak expiratory flow (PEF) to provide objective information for monitoring lung health.


Eligibility Criteria:
Inclusion Criteria:

* the diagnosis is Duchene's muscular Dystrophy only not other types,
* ambulated with or without assistance,
* oriented and endurance enough to understand orders to perform ventilation on the Blue Cherry; Geratherm Respiratory device.

Exclusion Criteria:

* any cognitive or neurological condition (other than Duchene's muscular Dystrophy),
* history of previous surgical operations that can affect pulmonary functions, and structural scoliosis
Prevention of Missed Opportunities for HIV Diagnosis by Promoting HIV Testing of Patients With Pneumococcal Pneumonia at Nice University Hospital (PneumoVIH)

According to usual practices, HIV testing should be performed for each patient diagnosed for pneumococcal pneumonia. Unfortunately, in 2018, only 27% of patients were tested for HIV following pneumococcal pneumonia in Nice University Hospital. The aim of PneumoVIH protocol is to promote HIV testing by reminding good practices to physicians. To achieve this, the team of the bacteriology laboratory will contact physicians for each patient positive for pneumococcal antigenuria to suggest HIV testing. This prospective public health action will aim to integrate this HIV test into routine care and to evaluate benefits through the number of HIV positive patients that will be diagnosed.


Eligibility Criteria:
Inclusion Criteria:

* Male or female 18 years or older with validated diagnosis of bacterial pneumococcal pneumonia.

Exclusion Criteria:

* documented history of HIV infection.
Study of Oral Upadacitinib to Assess Change in Disease Activity and Adverse Events in Adult Participants With Ulcerative Colitis or Crohn's Disease

Ulcerative colitis (UC) is an idiopathic, chronic, inflammatory disease affecting the colon. Crohn's disease (CD) is an incurable chronic inflammatory disorder of the gastrointestinal tract. This study will assess how safe and effective upadacitinib is in treating adult participants with moderate to severe ulcerative colitis and Crohn's disease. Adverse events and change in disease activity will be assessed.

Upadacitinib is an approved drug for treating Atopic dermatitis (AD), psoriatic arthritis (PsA), ankylosing spondylitis (AS), non-radiographic axial spondyloarthritis (nr-axSpA), ulcerative colitis (UC), and Crohn's disease (CD). Approximately 600 adult participants who are prescribed Upadacitinib by their physician in accordance with local label will be enrolled in Korea.

Upadacitinib will be administered in accordance with the terms of the local marketing authorization, and treatment of participants will be determined solely by the investigator. Participants in the study will be followed for up to 52 weeks.

There is expected to be no additional burden for participants in this trial. Participants will attend regular visits during the study at a hospital or clinic according to their routine clinical practice.


Eligibility Criteria:
Inclusion Criteria:

* Participants diagnosis with ulcerative colitis or Crohn's Disease suitable for the treatment with Upadacitinib.
* Participants prescribed upadacitinib in accordance with the approved local label.

Exclusion Criteria:

* Participants with any contraindication to Upadacitinib.
* Participants currently participating in another clinical research not including observational study.
Artesunate Ointment for the Treatment of Anal HSIL in HIV-negative Participants

This is a phase II double blind, placebo-controlled, randomized study of artesunate ointment for the treatment of HIV-negative men and women who have anal high grade squamous intraepithelial lesions (anal HSIL)

Eligible participants in this study are randomized 2:1 to receive either artesunate or placebo ointment for the treatment of anal HSIL. Both groups receive four 5-day cycles of ointment, at weeks 0, 2, 4, and 6. Participants are followed closely with anoscopy or high resolution anoscopy (HRA) at weeks 8, 18, 30, and 42. After the week 18 HRA visit, participants who have at least partial response will be followed with HRA at week 30.

Participants who are found to be non-responders at week 18 will undergo standard of care ablation.

Participants who are found to have anal HSIL at weeks 30 or 42 will be followed according to standard of care procedures.

Primary Objective: To evaluate the complete and partial histopathologic response to four 5-day cycles of artesunate ointment in adult patients with biopsy-proven HPV-associated intra-anal HSIL (18 weeks).

Secondary Objectives:

Efficacy:

To evaluate the viral clearance after four 5-day cycles of artesunate ointment To evaluate complete and partial intra-anal response To evaluate complete and partial peri-anal response To evaluate persistence of response throughout the study window

Safety:

To evaluate the safety of artesunate ointment for the treatment of intra-anal HSIL.

Eligibility Criteria:
Inclusion Criteria:

* Adult men and women age ≥ 18 years
* Capable of informed consent
* Biopsy-confirmed intra-anal high-grade dysplasia (AIN 2, AIN 3, anal HSIL) by HRA.
* Positive anal human papillomavirus (HPV) test.
* Women of childbearing potential agree to use birth control for the duration of the study.
* Laboratory values at Screening of:

  1. Serum alanine transaminase (SGPT/ALT) \< 5 x upper limit of normal (ULN)
  2. Serum aspartate transaminase (SGOT/AST) \< 5 x ULN
  3. Serum Bilirubin (total) \< 2.5 x ULN
  4. Serum Creatinine ≤ 1.5 x ULN
* Electrocardiogram (ECG) with no clinically significant findings as assessed by the Investigator.
* Weight ≥ 50kg

Exclusion Criteria:

* Pregnant and nursing women
* Diagnosis of low-grade anal dysplasia (AIN 1, LSIL), without the concomitant diagnosis of anal HSIL, by HRA
* Concurrent anal, vulvar, cervical, or penile cancer
* HIV-seropositivity
* Currently receiving systemic chemotherapy or radiation therapy for another cancer.
* Patients who are on medical treatment with systemic immunosuppressants or steroids (e.g., active autoimmune disease). Participants using nasal steroid treatments for allergic conditions may participate in the study.
* Concomitant use of strong UGT (Uridine-diphosphate-glucuronosyltransferase) inhibitors
* Concomitant use of imiquimod or 5-fluorouracil (5-FU) for the duration of the study
Retinal Pigment Epithelial Characteristics in Eyes With Neovascular Age-related Macular Degeneration Following Long-term Treatment With Anti Neovascular Endothelial Growth Factor

Purpose:

To assess retinal pigment epithelial (RPE) and retinal structural changes in eyes with neovascular age-related macular degeneration (AMD) treated with anti-vascular endothelial growth factor (anti-VEGF) during long-term follow-up and to evaluate morphological markers potentially influencing prognosis.

Methods:

18 patients (18 eyes) with neovascular AMD were recruited subsequent to completion the Avastin Versus Lucentis in Age Related Macular Degeneration (MANTA) study following a mean period of 84 months (range: 69-93 months). After receiving a loading dose of 3 intravitreal anti-VEGF injections subsequent to baseline of the MANTA study, patients were treated as-needed \[pro re nata (PRN)\]. Functional and morphological changes were assessed using spectral domain optical coherence tomography (SD-OCT).


Eligibility Criteria:
Inclusion Criteria:

* Inclusion and exclusion criteria corresponded to the criteria of the MANTA study

Exclusion Criteria:

* Inclusion and exclusion criteria corresponded to the criteria of the MANTA study
Multimodal Computed Tomography in Patients With Acute Hemorrhagic Stroke

Acute hemorrhagic stroke is a series of neurosurgical diseases characterized by bleeding with high morbidity and mortality. It accounts for about 20% of all strokes worldwide and mainly includes subtypes such as intracerebral hemorrhage (ICH) and subarachnoid hemorrhage (SAH). Multimodal computed tomography including non-contrast computed tomography, computed tomography angiography and computed tomography perfusion, is of great important in understanding pathophysiological changes, evaluating prognosis and guiding interventions in these diseases.

Study overview: The data of the population in the MACTAHS study will be prospectively collected. The CT strategies for acute hemorrhagic stroke are mainly three categories: non-contrast computed tomography, computed tomography angiography and computed tomography perfusion. Each participants will be followed at least until 1 year after discharge. Finally, investigators will clarify the prognostic value of multimodal CT for patients with acute hemorrhagic stroke.

Sample size: About 10000 patients will be enrolled in this study. All the population will be expected to undergo non-contrast computed tomography, computed tomography angiography and computed tomography perfusion.

Study endpoints: Neurological functional outcomes, delayed ischemia and infarction, recurrent bleeding, cognition and emotional dysfunction, systemic in-hospital systemic complications, rehabilitation and recovery status will be evaluated and follow-up would be completed.

Eligibility Criteria:
Inclusion Criteria:

1. age ≥ 18, ≤ 85 years;
2. presence with hemorrhagic stroke

Exclusion Criteria:

1. with a history of previous history of ischemic/hemorrhagic stroke;
2. admission to the emergency department more than a week after symptom onset;
3. serious medical history or existing comorbidities;
4. physical disability due to previous diseases;
5. prior treatment such as external ventricular drainage, digital subtraction angiography and lumbar puncture in other institution;
6. poor original image quality;
7. incomplete follow-up.