cyrilzakka/clinical-trials huggingface dataset:
Optimization of DE-CTPA Images and Diagnostic Pathway: Using Low Concentration Iodine Contrast Material

The investigators aimed to compare the image quality and diagnostic performance of DECTPA using lower concentration iodine contrast materials and using normal concentration iodine contrast materials in the evaluation of suspected pulmonary embolism.

All patients met the inclusion and exclusion criteria will be given written informed consensus. The enrolled patients will randomly receive one of the three injection protocols: A: 30mL Iomeprol (Iomeron 300, Bracco Imaging, Milano, Italia) injected at a flow rate of 4mL/s; B: 50mL Iomeprol (Iomeron 300, Bracco Imaging, Milano, Italia) injected at a flow rate of 4mL/s; C: 50mL Ioversol (Ioversol 350, Hengrui, Jiansun, China) injected at a flow rate of 4mL/s. A and B groups are both lower concentration iodine contrast material groups, with different total iodine loads.

Eligibility Criteria:
Inclusion Criteria:

* Age greater than 18 years old
* Clinical suspicion of pulmonary embolism suggests CTPA examination (Wells score\>4 or D-2 polymer elevation)
* Patient's general physical condition tolerates CTPA examination

Exclusion Criteria:

* Allergy to iodine contrast agents
* Hyperthyroidism
* Pregnancy
* Weight greater than 80kg
* Heart failure patients, NYHA heart function level III or IV
Effect of Anesthetics on Microcirculation in Patients Undergoing Off-pump Coronary Artery Bypass Surgery

Volatile anesthetics, such as sevoflurane and desflurane, are commonly used in patients undergoing cardiac surgeries including off-pump coronary artery bypass. However, the effect of volatile anesthetics on microcirculation in patients undergoing off-pump coronary artery bypass has not been well conducted.

This is a prospective randomized clinical trial investigating the effect of sevoflurane vs. desflurane on tissue microcirculation in patients undergoing off-pump coronary artery bypass surgery. Eligible patients are going to be randomized to receive sevoflurane or desflurane, as a maintenance anesthetic, during the surgery. Tissue oxygen saturation and microcirculatory changes, such as an occlusion and recovery slope, during vascular occlusion test will be recorded during the surgery. The primary end point of the study is the difference in tissue oxygen saturation between the groups.

Eligibility Criteria:
Inclusion Criteria:

* scheduled for off-pump coronary artery bypass surgery

Exclusion Criteria:

* any deformity or vascular abnormalities on upper arms
* cannot receive sevoflurane or desflurane for any reason (muscular diseases, etc)
* uncontrolled diabetes
* peripheral vascular disease
* severe renal dysfunction (end-stage renal disease)
* refuse to enroll
* pregnant
Safety and Efficacy of Remote Ischemic Conditioning in Patients With Acute Ischemic Stroke

he purpose of this study is to determine the efficacy and safety of remote ischemic conditioning for acute ischemic stroke.

In this study, 912 cases of ischemic stroke in 48 hours were included in 5 centers in China according to the principle of random, double-blind and parallel control .The experimental group receive basic treatment and remote ischemic conditioning for 200mmHg, 2 times per day for 7 consecutive days .The control group receive basic treatment and remote ischemic conditioning control for 60mmHg, 2 times per day, 7 days in a row . Two groups will be followed up for 90 days to evaluate the efficacy and safety of remote ischemic conditioning therapy.

Eligibility Criteria:
Inclusion Criteria:

* 1）Age≥18 years, \< 80 years, regardless of sex；
* 2）Patients with clinically definite diagnosis of acute ischemic stroke and able to commence RIC treatment within 12 hours of stroke onset
* 3）Baseline NIHSS score\>5, and≤25 ；
* 4）GCS score ≥8；
* 5）Signed and dated informed consent is obtained

Exclusion Criteria:

* 1) Patients with suspected posterior circulation infarction；
* 2) Patients who undergo thrombolytic therapy or endovascular treatment；
* 3) mRS≥2 score before the onset of the disease；
* 4) Double upper limbs or lower limbs paralysis was found in this case；
* 5）Active bleeding of organs within 6 months of admission or current, including cerebral hemorrhage, subarachnoid hemorrhage, gastrointestinal hemorrhage, fundus hemorrhage and so on；
* 6) Other intracranial lesions, such as cerebrovascular malformation cerebral venous diseases, tumor and other diseases involving the brain；
* 7) Treated blood pressure ≤90mmHg/60mmHg or≥180mmHg/100mmHg；
* 8) Severe organ dysfunction or failure；
* 9) Persons suffering from severe hematological diseases or severe coagulation disorder dysfunction；
* 10) Those who had a history of severe trauma or had major surgery within 6 months prior to admission；
* 11) The patients who had the contraindication of remote ischemic conditioning treatment, such as severe soft tissue injury, fracture or vascular injury in the upper limb；Acute or subacute venous thrombosis, arterial occlusive disease, subclavian steal syndrome, etc；
* 12) Pregnant or lactating women；
* 13) Previous remote ischemic conditioning therapy or similar treatment；
* 14) Patients with a life expectancy of less than 3 months or patients unable to complete the study for other reasons；
* 15) Severe hepatic and renal dysfunction
* 16) Unwilling to be followed up or treated for poor compliance；
* 17) He/She is participating in other clinical research or has participated in other clinical research or has participated in this study within 3 months prior to admission；
* 18) Other conditions that the researchers think are not suitable for the group.
Clinical Effects of Oral Trehalose In Patients With Spinocerebellar Ataxia 3

There are no clinically established treatments which have been proven to delay the disease progression in spinocerebellar ataxia (SCA) 3. Most available treatments are only for symptom alleviation, and thus the majority of patients will eventually progress to needing and wheel chair and eventually bedridden.

As trehalose appear to be potentially promising treatment in SCA, the investigators aim to conduct this study using oral trehalose in our genetically confirmed SCA 3 patients.

This prospective single arm interventional study involved 13 genetically confirmed spinocerebellar ataxia (SCA) 3 patients with no concomitant diabetes, over 6 months. Following baseline assessment, patients were instructed to ingest 100g of oral trehalose diluted in 500ml of water or other beverages daily. Assessments were performed at baseline, 2, 4 and 6 months using ataxia rating scales (SARA, SCAFI and INAS) and EQ-5D-3L scale for quality of life assessment.

Eligibility Criteria:
Inclusion Criteria:

1. DNA diagnosis of SCA 3 in the study subject of his/ her affected family member(s)
2. Consent to participate in the study
3. The age of 18 years and older

Exclusion Criteria:

1. Unconfirmed SCA 3
2. Concomitant disorder(s) that affect SARA and other ataxia measures used in this study
3. Diabetes
4. Malabsorption of trehalose underlies intolerance to mushrooms, since the lack of absorption results in diarrhoea and intestinal distress.
5. Less than 18 years old
Memory Inhibition and Delayed Onset Post-traumatic Stress Disorder in Older Subjects

In the elderly, we can see a post-traumatic syndrome associated with an event that occurred before old age that had not previously manifested or not fully manifested.

This little-known pathology and notable psychiatric co-morbidities (depression, anxiety) can take in elderly subjects different masks that interfere with diagnosis and treatment.

The data in the literature suggest that this Post-Traumatic Stress Disorder with Delayed Expression (TSPT-R) may be related to a deficiency of the executive functions of inhibition, and more particularly a deficit of mental memory inhibition and therefore the removal of unwanted memories.


Eligibility Criteria:
Inclusion Criteria:

-

Regarding the constitution of the group patient (TSPT-R):

* Subjects 65 years of age or older
* Clinical diagnosis of delayed-onset PTSD according to DSM-5 criteria after 65 years
* The traumatic event must have taken place at the latest before 65 years
* Affiliated person or beneficiary of a social security scheme.
* Written consent before any examination required by research)

Regarding the constitution of the control group:

* Subjects 65 years of age or older
* No diagnosis of PTSD (delayed or not) or history of PTSD (delayed or not)
* Affiliated person or beneficiary of a social security scheme.
* Written consent before any examination required by the research).

Exclusion Criteria:

* For both groups:
* Acute or chronic cognitive impairment known
* GRECO MMSE pathological score less than or equal to the pathological threshold weighted according to level of education and age, namely:

  * 22 if no diploma
  * 23 if certificate of study
  * 25 if patent
  * 26 if bin or more
  * Remove one point at each threshold if age\> 80 years
* Sensory or motor disorder preventing the passing of different tests
* Psychotic disorder
* Mood disorder in decompensation (for depression, HAD-D score equal to or greater than 11)
* Disorder of the use of a moderate or severe substance (except tobacco).
* Patients under guardianship or curatorship.
The Scleroderma Biorepository and Pathogenesis Study (STOP Scleroderma)

The Scleroderma bioreposiTOry and Pathogenesis Study (STOP Scleroderma) will help researchers use clinical data and human biospecimens to investigate why scleroderma patients develop certain complications from their disease. Patients with confirmed scleroderma, raynauds or positive autoantibodies are invited to participate. This research may help us understand how to prevent and treat scleroderma and other diseases.


Eligibility Criteria:
Inclusion Criteria:

* Age \>18 years
* Able to give informed consent.
* Diagnosed with scleroderma or with positive autoantibodies

Exclusion Criteria:

* \< 18 years old
Heat Shock Protein Inhibitor- MPT0B640 for COVID-19 Infection

Indication : Treatment of Subject with COVID-19 infection Phase : Phase I Duration of Study : 12 day Sample size : at least 15 subjects Methodology : Classical 3+3 design Investigational Product : MPT0B640, 15, 30, 60, 80 and 100mg, oral suspension Study Objective

1. Primary Objective To determine the maximum tolerated dose (MTD) or maximum feasible dose (MFD) of MPT0B640
2. Secondary Objectives To evaluate the safety and tolerability of MPT0B640 during entire study period To assess the efficacy of MPT0B640 To characterize the 48 hours PK of MPT0B640


Eligibility Criteria:
Inclusion Criteria:

Subjects must meet all inclusion criteria as listed below:

1. Age ≥18 years at time of signing Informed Consent Form
2. Laboratory (quantitative Polymerase Chain Reaction, qPCR) confirmed infection with 2019-nCoV.
3. Lung involvement confirmed with chest imaging
4. Hospitalized with a SaO2/SPO2≤94% on room air or PaO2/FiO2 ratio \<300mgHg
5. ≤7 days since illness onset
6. Must agree not to enroll in another study of an investigational agent prior to completion of Day 12 of study.

Exclusion Criteria:

1. Physician makes a decision that trial involvement is not in patients' best interest, or any condition that does not allow the protocol to be followed safely.
2. Severe liver disease (e.g. Child Pugh score ≥ C, AST\>5 times upper limit)
3. Pregnant or breastfeeding, or positive pregnancy test in a pre-dose examination
4. Patients with known severe renal impairment (estimated glomerular filtration rate ≤30 mL/min/1.73 m2) or receiving continuous renal replacement therapy, hemodialysis, peritoneal dialysis
5. Will be transferred to another hospital which is not the study site within 72 hours.
6. Receipt of any experimental treatment for 2019-nCoV (off-label, compassionate use, or trial related) within the 30 days prior to the time of the screening evaluation.
Carbapenem-resistant Pseudomonas Aeruginosa: the SAMPAN Study.

Pseudomonas aeruginosa causes severe infections in hospitalized patients. The worldwide emergence of carbapenem-resistant P. aeruginosa (CR-PA) makes infections by these pathogens almost untreatable. The World Health Organization now ranks CR-PA highest in the list of 'urgent threats'. Information for action to prevent further emergence has to come from insight into sources and transmission routes through smart surveillance. At present, a smart surveillance strategy is not available for CR-PA. The aim of this project is to develop a globally-applicable smart surveillance strategy to guide action against the spread of CR-PA. Since P. aeruginosa prefers moist niches, we will focus on the human-water interface. First, highly-sensitive methods to detect CR-PA in specific environmental and human niches will be developed. Subsequently, CR-PA will be collected in three study sites with increasing prevalences of CR-PA, increasingly warmer climates, and different water situations: Rotterdam (The Netherlands), Rome (Italy), Jakarta (Indonesia). CR-PA will be searched for in a variety of niches in the environment outside and inside the hospital, and in healthy humans and hospitalized patients. Whole genome sequencing will be performed to compare the CR-PA from different sources and identify transmission routes. Our project will provide insight into the relative contribution of the different potential reservoirs of CR-PA to its spread in different settings which will be used for the development of a globally-applicable surveillance strategy for CR-PA to guide preventive actions.


Eligibility Criteria:
Inclusion Criteria healthy individuals:

* All healthy individuals living in a "high-risk area" in Rotterdam, Rome or Jakarta.

Exclusion Criteria healthy individuals:

* No signed consent sheet

Inclusion Criteria patients:

* Must be aged 18 years or older;
* Should be capable of providing answers to the questions in the questionnaire by himself/herself;
* Should have a minimum expected length of stay of at least 24 hours;
* Inclusion only once during the sampling year.

Exclusion Criteria patients:

* Cystic fibrosis patients
* No signed consent sheet.
Therapeutic Education for Harm Reduction in People With Alcohol Use Disorder

Alcohol is the most harmful psychoactive substance in terms of overall damage. Although abstinence remains the objective of most pharmacological and non-pharmacological approaches addressing alcohol use disorder (AUD), new therapeutic objectives of reduced alcohol intake and controlled-drinking have emerged.

ETHER ("Education THEérapeutique pour la Réduction des dommages en alcoologie" or therapeutic education for the reduction of alcohol-related harms) is an ongoing, multicentre, community-based mixed-methods study, which aims to evaluate the innovative therapeutic patient education (TPE) programme named "Choizitaconso". This programme teaches psychosocial skills to people with alcohol use disorder (PWAUD), to help them (re)establish controlled drinking and reduce harms.

The evaluation of the programme will rely on a sequential explanatory design, where the qualitative study (16 semi-structured interviews) will assist in explaining and interpreting the findings of the controlled before-and-after quantitative study.

ETHER's quantitative component is a 6-month controlled study which evaluates the effectiveness of "Choizitaconso" by comparing 30 PWAUD following the programme with a control group of 60 PWAUD not following it. All 90 PWAUD are individually interviewed using standardized face-to-face and phone-based interviews.

34 questions on alcohol-related harms were identified in the international literature and approved by the PWAUD community. The sum of these harms, considered as a measure of the individual "burden" related to alcohol use, will be used as principal outcome.

Secondary outcomes are quantity and frequency of alcohol consumption, craving for alcohol, coping strategies, Health-Related Quality of Life (HRQL), self-confidence to resist drinking, anticipated and internalized stigma, treatment self-regulation, anxiety and depressive symptoms, alcohol-related neuropsychological impairments and capabilities (i.e., a measure of wellbeing for the general adult population, used in economic evaluations).

Primary and secondary outcomes will be collected in face-to-face and phone-based interviews at enrolment and 6 months after enrolment. We will use a binomial test and linear regression models to assess the impact of the TPE programme on changes in the principal and secondary outcomes, while adjusting for other correlates and confounders.

The study's qualitative component comprises semi-structured interviews of 16 PWAUD who completed the TPE programme at least 6 months before the interview. Qualitative interviews will be analysed using thematic analysis.

Eligibility Criteria:
Inclusion Criteria:

* at least 18 years old
* fluent in French speaker
* able to provide written, informed consent
* reachable by phone
* followed-up for Alcohol Use Disorder

Exclusion Criteria:

* cocaine or opiate dependence
* being a legally-protected adult (tutorship, curatorship)
* being pregnant
* participation in another study during the duration of follow-up (6 months)
* having severe cognitive impairment which could conflict with successful group work
A Multicenter Open-label Clinical Study on the Prevention of Premature Ovarian Failure After HSCT

HSCT is an effective method to cure hematologic malignancies. However, the reproductive system is prone to be damaged during radiotherapy and chemotherapy before transplantation, leading to ovarian failure, followed by infertility and premature ovarian failure (POF), which seriously affect the long-term quality of life of patients. This clinical trial aimed to observe the effect of Gonadotropin-releasing hormone analogues (GnRHa) on ovarian function in women of reproductive age after HSCT, so as to provide clinical evidence for whether GnRHa should be used for the prevention of POF.

Hematopoietic stem cell transplantation (HSCT) is an effective method for the treatment of hematologic malignancies. However, in the process of radiotherapy and chemotherapy before transplantation, the reproductive system is vulnerable to damage, leading to ovarian failure, which leads to infertility and premature ovarian failure (POF), seriously affecting the long-term quality of life of patients. Exogenous injection of gonadotropin-releasing hormone analogue (GnRHa) has a significant effect on fertility preservation in adolescent and reproductive female patients with breast cancer and cervical cancer. However, there is a lack of large-scale clinical studies on POF in HSCT. Therefore, this clinical trial aimed to observe the effect of GnRHa application before transplantation on ovarian function in women of reproductive age after transplantation, so as to provide clinical evidence for whether GnRHa application for fertility function protection.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with acute leukemia, MDS, lymphoma, multiple myeloma, SAA and other hematological diseases, with the indications for autologous or allogeneic hematopoietic stem cell transplantation.
* Female, aged 18-45 years.
* Ovarian function was normal before treatment.
* Volunteer to participate in clinical research and sign the informed consent form.

Exclusion Criteria:

* No menstruation before treatment, undergone hysterectomy or ovarian surgery.
* Abnormal sexual development.
* Received radiotherapy.
* Combined with tumors affecting gonadal function.
* Deep vein thrombosis.
* Hypertension, liver and/or kidney dysfunction cannot tolerate hematopoietic stem cell transplantation.
ARX788 in HER2-positive Metastatic Breast Cancer Patients

A phase 2 study of ARX788 given every 6 weeks in HER2-positive, metastatic breast cancer patients.

A single arm, phase 2 study of ARX788 in HER2-positive, metastatic breast cancer patients. The ARX788 will be administered every 6 weeks (Q6W) intravenous (IV) infusion.

Eligibility Criteria:
Inclusion Criteria:

* 18 to 75 years old (including upper and lower limits), male or female;
* Unresectable locally advanced, recurrent or metastatic BC;
* Has previously received ≤ two lines of chemotherapy (excluding hormone therapy) for recurrent or metastatic BC;
* Tissue samples determined to be HER2 positive (defined as IHC3+ or FISH+);
* Has at least one measurable target lesion as per RECIST1.1 criteria;
* Has recovered from any AE (≤ Grade 1) related to prior surgery and prior cancer treatment;
* Adequate bone marrow, liver, kidney and coagulation function;
* ECOG Performance Status Score of 0-1;
* Voluntarily sign the informed consent, have good compliance and are willing to comply with the follow-up visit.

Exclusion Criteria:

* Has known history to be allergic to any active ingredient or excipient of ARX788;
* With meningeal metastases or disseminated brain metastases or active brain metastases, who need radiation, surgery or drug therapy;
* Has pericardial effusion, pleural effusion or ascites effusion with clinical symptoms, signs or require symptomatic treatment;
* Has interstitial lung disease requiring steroid therapy, a history of drug-induced interstitial lung disease, a history of radiation pneumonitis, or any evidence indicating clinically active interstitial lung disease;
* Has any eye disease that require medical intervention such as keratitis, corneal diseases or active eye infection;
* Has cardiac insufficiency;
* Uncontrolled hypertension;
* Has evidence of severe or uncontrollable systemic diseases;
* Received live vaccines within 4 weeks before the first use of the investigational product or plans to receive live vaccines during the trial;
* Breastfeeding female, or who has childbearing potential with a positive baseline pregnancy test or who is unwilling to use effective contraception during the trial;
* Is unwilling or unable to stop wearing corneal contact lens during the trial;
* Has received any systemic anti-tumor therapy (with the exception of endocrine therapy, with an interval of at least 7 days) within 28 days (or at least 5 half-lives) before the first use of the investigational product;
* Has any mental or cognitive disorder that may restrict his/her understanding and execution of the informed consent form;
* Other conditions that the Investigator considers inappropriate for participation in this trial, such as poor compliance.
Children's Preferences on Digital and Conventional Impression Techniques

The goal of this crossover study is to compare children's perceptions and preferences regarding digital and conventional impression techniques in the 5- to 11-year-old age group. The main questions it aims to answer are

* Which impression methods do kids prefer?
* What influences kids' perception of impression methods?

Dental impressions will be obtained using both the conventional alginate impression (CAI) (Cavex ColorChange; Cavex Holland BV, Haarlem, the Netherlands) and digital intraoral scanning procedure (DIS) (3Shape TRIOS Color, 3Shape, Copenhagen, Denmark). After each procedure, patients will score their perceptions using a Modified Impression Perception Test, a 5-point Likert scale, for gag reflex, queasiness, difficulty breathing, uncomfortable feeling, pain perception, chairside time, and stress levels. Dental anxiety will be assessed using the Visual Anxiety Scale (1-10). Children will also be asked about their preferences and reasons in one or two sentences. Content analysis will be performed on answers to open-ended questions. Statistical analysis will be done using Fisher's Exact test.


Eligibility Criteria:
Inclusion Criteria:

* No prior exposure to either digital or conventional impression techniques
* Absence of temporomandibular joint disorders and periodontal disease
* Cleft lip and/or palate, or other significant craniofacial anomalies
* No current use of psychiatric or neuropathic medications

Exclusion Criteria:

* Individuals with a known history of dental anxiety or a pronounced gag reflex