cyrilzakka/clinical-trials huggingface dataset:
Treatment of Primary Basal Cell Carcinomas of the Skin With Combination of Topical Imiquimod and Cryosurgery

The purpose of this study is to evaluate the efficacy of cryosurgery during continuing imiquimod application in the treatment of basal cell carcinoma of the skin.

Evaluation of efficacy:

* Number of patient: N=50
* Inclusion criteria: Basal cell carcinoma of the skin proven with biopsy
* Exclusion criteria: (1) Size of the tumors \>2cm; (2) Distance from the eyelid \<1cm; (3)Number of tumors \>5

Treatment protocol: Patients will apply imiquimod daily for 14 days on the tumor and a rim of 2mm around the tumor. On day 14 a session of mild cryosurgery (2 cycles of 10-15 seconds, with open spray liquid nitrogen) will be applied and the patients will continue application of imiquimod for another 3 weeks before being evaluated again. Persisting erosion will be considered as persistence of the tumor and imiquimod will be continued for another 3 weeks with/or without a cryosurgery session. The patients will be evaluated at 1,3,6,12 months after discontinuation of imiquimod and yearly thereafter for relapse. In case of clinical relapse, it will be confirmed by biopsy.

Eligibility Criteria:
Inclusion Criteria:

* Basal cell carcinoma of the skin
* Size \< or = 2cm
* Number of tumors \< or = 5
* Distance from eyelids, mouth \>1cm

Exclusion Criteria:

* Size \>2cm Number of tumors \> 5 Distance from eyelids or mouth \< or = 1cm
A Study to Evaluate the Efficacy of SAGE-217 in the Treatment of Adult Participants With Major Depressive Disorder

This study is a phase 3, multicenter, double-blind, randomized, placebo-controlled study evaluating the efficacy of SAGE-217 in the treatment of adult participants with major depressive disorder (MDD).

This study was previously posted by Sage Therapeutics. In November 2023, sponsorship of the trial was transferred to Biogen.

Eligibility Criteria:
Inclusion Criteria:

1. Participant had a diagnosis of MDD with symptoms that had been present for at least a 4-week period.
2. Participant had a Montgomery-Åsberg Depression Rating Scale (MADRS) total score of ≥32 and a 17-item Hamilton Rating Scale for Depression (HAM-D) total score ≥22 at screening and Day 1 (prior to dosing).

Exclusion Criteria:

1. Participant had active psychosis.
2. Participant had attempted suicide associated with the current episode of MDD.
3. Participant had a medical history of bipolar disorder, schizophrenia, and/or schizoaffective disorder.
CD19/BCMA CAR-T Cell Therapy for Refractory/Relapsed Lupus Nephritis

A Clinical Study of the Safety and Efficacy of CD19/BCMA CAR-T Cell Therapy for Refractory/Relapsed Lupus Nephritis.

In this study, 9 patients with relapsed refractory Lupus Nephritis were proposed to undergo CD19/BCMA CAR-T Cells therapy. Under the premise that its safety has been clarified in previous studies, further observation and evaluation of the effectiveness of CD19/BCMA CAR-T Cells therapy for relapsed refractory Lupus Nephritis; At the same time, on the basis of expanding the sample size, more safety data on CD19/BCMA CAR-T Cells treatment for relapsed refractory Lupus Nephritis were accumulated.

Eligibility Criteria:
Inclusion Criteria:

* 1. Age ≥18 years old;
* 2. A clinical diagnosis of systemic lupus erythematosus (SLE) according to the 2019 American College of Rheumatology (ACR) and European Federation of Rheumatology Societies (EULAR) /ACR classification criteria. Grade III, IV, or V lupus nephritis was confirmed by biopsy according to the 2003 ISN/RPS standard.
* 3. SLEDAI-2K ≥8 during screening
* 4. failure to respond to two or more standard immunosuppressive therapies, or relapse (increased disease activity index and need to adjust drug dose or type);
* 5. Expected survival \>12 weeks;
* 6. Fertile women and men agree to use appropriate contraceptive methods before entering the study, during study participation, and for 6 months after transfusion (the safety of this therapy for the unborn child is not known);
* 7. Volunteer to participate in this experiment and sign the informed consent.

Exclusion Criteria:

* 1. History of craniocerebral trauma, conscious disturbance, epilepsy, cerebrovascular ischemia, and cerebrovascular hemorrhagic diseases;
* 2. Electrocardiogram shows prolonged QT interval, severe heart diseases such as severe arrhythmia in the past;
* 3. Active infected persons who are not cured:
* 4. Active hepatitis B or C virus infection;
* 5. Patients who have taken more than 20mg/d of prednisone or equivalent systemic steroid drugs within 1 week prior to treatment (except those who have recently or currently taken inhaled steroids);
* 6. Have used any gene therapy products before;
* 7. Insufficient amplification ability (\<5 times) in response to CD3 / CD28 costimulation signals;
* 8. ALT/AST\>3 times the normal amount or bilirubin \>2.0 mg/dl;
* 9. Those who have other uncontrolled diseases that the researcher deems unsuitable for enrollment;
* 10. HIV-infected people;
* 11. Any situation that the investigator believes may increase the risk to the subject or interfere with the test results.
Rapid Diagnosis of COVID-19 by Chemical Analysis of Exhaled Air

Since the start of 2020, the new SARS-CoV-2 coronavirus is causing a real global health crisis.

In France, nasopharyngeal swabs are used to obtain the sample needed for respiratory infection screening. There are three major difficulties with this type of sampling:

I) It is really unpleasant for the patient because the device has to be pushed into the nostril to reach the nasopharynx. It causes some patients to bleed or even feel uncomfortable.

II) It is not easily accepted by children. III) It is dependent on the availability of swabs. Faced with these difficulties linked to the initial sampling, new methods are being studied to enable a rapid and non-invasive diagnosis of COVID-19 based on the instantaneous identification of metabolites or volatile organic compounds (VOCs).

Due to their sensitivity and the wealth of information that can be provided, the most promising techniques are based on mass spectrometry coupled with a soft ionisation system. For example, on-line exhaled air analysis is capable of detecting a very large number of VOCs. Various tests on metabolites in the exhaled air have already been carried out without being totally conclusive because the existing instruments suffer from various limitations:

I) poor repeatability/accuracy in the chemical characterisation of exhaled air ; II) too high specificity (detection of only part of the emitted compounds); III) too limited sensitivity; IV) and poor adaptation to be deployed in a clinic.

In order to overcome these various limitations, we propose the use of a new generation of mass spectrometer: Vocus PTR-TOF. The Vocus PTR-TOF is a Proton Transfer Mass Spectrometer (PTR-MS) developed for the detection, in real time, of trace VOCs in industrial environments, laboratories or directly in the environment. This new generation of instrument offers the following advantages:

I) unequalled sensitivity :

II) a robust ionisation system not affected by environmental conditions (relative humidity...) ; III) a high mass resolution allowing precise identification of compounds ; IV) a compact and durable architecture allowing deployment in a constrained environment such as hospital, airport... The sensitivity and speed of measurement allow the expiration process to be monitored in real time, bringing an additional dimension to the measurement and the chances of success.


Eligibility Criteria:
Inclusion Criteria:

* Symptomatic and asymptomatic outpatient without hospitalisation criteria
* No medical contraindications to nasopharyngeal swabbing (deviation of the nasal septum, epistaxis, anticoagulant treatment).
* Patient able to blow into the test device
* Patients or parents with parental authority who have been informed of the study and have not objected to participating in it

Exclusion Criteria:

* Major subject under guardianship or curatorship or unable to consent to study.
* Subject under safeguard of justice
* Minor patient (age \< 6 years).
Study of Ketamine for Depression in Cancer Patients Receiving Palliative Care

This is a phase 2 study of the drug ketamine for the treatment of depression in cancer patients receiving palliative care. The purpose of this study is to see how useful the drug is at decreasing the severity of depression these patients. Ketamine will be given through the nose.


Eligibility Criteria:
Inclusion Criteria:

* Provide written, voluntary informed consent prior to study enrollment. Participants must be capable of consenting to treatment as substitute decision makers will not be allowed to consent to the study on their behalf
* Males and females ≥ 18 years of age
* Patient is receiving palliative care at Princess Margaret Cancer Centre (PM) including all in-patient units and outpatients
* Meet Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria for Major Depressive Disorder (MDD), with a current Major Depressive Episode (MDE)
* Depression severity must be in the moderate to severe range, as determined by a Montgomery-Åsberg Depression Rating Scale (MADRS) score greater than or equal to 20
* Participants must have a confirmed diagnosis of cancer and an estimated life expectancy of less than twelve months, as determined by the palliative care physician

Exclusion Criteria:

* Presence of delirium or suspected delirium
* Severe hypertension or severe cardiac decompensation
* Previous stroke history
* History of intolerability, hypersensitivity or allergy to ketamine
* Patients with bipolar disorder, psychotic disorders, substance use disorders or active suicidality based on a Mini-International Neuropsychiatric Interview (MINI) conducted by a delegated physician will also be excluded
* Current symptoms of psychosis or perceptual disturbances of any kind per investigator discretion
* Pregnancy or breastfeeding women
Effectiveness of Pregnancy Tests as an Assessment Tool to Identify Continuing Pregnancy

This randomized study will examine the effectiveness of two types of pregnancy tests (a semi-quantitative test and a high sensitivity test) to identify continuing pregnancy at home at various time points after early medical abortion. The first test a semi-quantitative panel test marketed under the brand name dBest (AmeriTek, Seattle WA, USA). This urine-based, one-step kit has been used in two previous studies in Vietnam (12, 13). The second test is a locally available urine dipstick (Quickstick one-step hCG Pregnancy Test, Phamatech, San Diego, CA, USA).

1. The investigators hypothesize that 99% of the SQPT and 35% of the HSPT will correctly identify ongoing pregnancy at day 14.
2. The investigators hypothesize that 99% of the SQPT and 25% of the HSPT will correctly identify ongoing pregnancy at day 7.
3. The investigators hypothesize that 75% of the SQPT and 10% of the HSPT will correctly identify ongoing pregnancy at day 4.


Eligibility Criteria:
Inclusion Criteria:

* Gestational age ≤63days from LMP
* Eligible for mifepristone- misoprostol medical abortion according to clinic guidelines(national guidelines stipulate that women can receive medical abortion thru 63 days LMP at Hung Vuong (tertiary level) hospital; women with gestations up to 49 days LMP can receive medical abortion at Hocmon (district) hospital)
* Willing to follow instructions of the provider regarding use of the pregnancy tests
* Able to read and write to use pregnancy test at home
* Willing to be randomized to perform one of two types of urine pregnancy tests at three time points at home
* Willing to provide an address and/or telephone number for purposes of follow-up
* Agrees to return for follow-up visit at clinic to confirm abortion status
* Wishes to participate in the study
* Able to consent to study participation

Exclusion Criteria:

* Women not meeting the above inclusion criteria
Deep Cervical Lymphatlc-Venous Anastomosis Surgery for the Treatment of Alzheimer's Disease: A Pilot Study (DIVA Study)

The goal of this clinical trial is to To demonstrate the Safety and Efficacy of dcLVA Surgery for the Treatment of Alzheimer's Disease. Patients who meet the inclusion and exclusion criteria and consent to participate will be randomly assigned to either the experimental group (receiving dcLVA surgery plus standard medication) or the control group (receiving standard medication alone)

Participants will:

Undergo cognitive assessment and brain MRI assessment; Undergo a lumbar puncture; Undergo an injection of 20ml of gadodiamide contrast agent at a concentration of 0.5 mmol/L (1ml gadodiamide: 20ml 0.9% saline).

Primary Outcome Measures: The change in the sum of Clinical Dementia Rating Scale (CDR) scores at 12-month in relative to baseline

This study aims to enroll patients diagnosed with AD. Patients who meet the inclusion and exclusion criteria and consent to participate will be randomly assigned to either the experimental group (receiving dcLVA surgery plus standard medication) or the control group (receiving standard medication alone). Following randomization, patients will undergo cognitive and brain MRI assessments, a lumbar puncture, and an injection of 20ml of gadodiamide contrast agent at a concentration of 0.5 mmol/L (1ml gadodiamide: 20ml 0.9% saline). MRI imaging scans will be conducted at 4 hours, 24 hours, and 48 hours post-injection to measure the dural signal unit ratio, which will be used to assess glymphatic clearance function. The study will track changes in cognitive function and glymphatic clearance function at baseline and during follow-up periods (7 days post-surgery, 6 months, and 12 months) and will evaluate the safety of the two treatment approaches.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed as an AD patient according to biological markers and clinical symptoms;
* Over 35 years old and with an MMSE or MOCA score ≤ 26;
* The patient or family member has signed an informed consent form.

Exclusion Criteria:

* Inability to cooperate with lumbar puncture;
* Cognitive impairment due to neurological infections (e.g., HIV, neurosyphilis, autoimmune encephalitis) or systemic diseases (e.g., diabetes, thyroid dysfunction);
* Significant organ dysfunction (heart, lung, liver, kidney);
* Coagulation disorders or contraindications to surgery;
* Inability to fully cooperate with follow-up visits.
Mixture of Prebiotics on Intestinal Microbiota of Patients Receiving Abdominal Radiotherapy.

Abdominal and pelvic radiotherapy (RT) reduces the renewal capacity of the epithelium. Rectal biopsies obtained from patients receiving pelvic RT have revealed atrophy of surface epithelium, acute cryptitis, crypt abscesses, crypt distortion and atrophy, and stromal inflammation. Modifications in intestinal microbiota, such as an increase in the number of pathogens, may contribute to intestinal injury. The prebiotic effect of a carbohydrate is assessed by its capacity to stimulate the proliferation of healthy bacteria (Bifidobacterium, Lactobacillus) rather than pathogenic bacteria (Clostridium, E. coli).

The hypothesis of the study is that a mixture of inulin and fructooligosaccharide could modulate Lactobacillus and Bifidobacterium and reduce the intestinal injury in patients affected of gynaecological cancer and treated with abdominal radiotherapy.


Eligibility Criteria:
Inclusion Criteria:

* female gender, age ≥ 18 years, and a diagnosis of gynaecologic cancer requiring postoperative pelvic RT.

Exclusion Criteria:

* previous RT, previous or adjuvant chemotherapy, other types of pelvic tumours or other gynaecologic malignancies, antibiotic or immunosuppressive treatment one week before inclusion or during treatment, and the presence of acute or chronic gastrointestinal disease contraindicating ingestion of the fibre
Prospective Cohort Study of Complications and Outcomes in Cirrhosis

This is a multi-center, nested cohort study intended to investigate the prevalence, risk factors, and outcomes of complications in patients with acutely decompensated cirrhosis, especially focused on Cytomegalovirus (CMV) reactivation, bacterial infections, hepatic encephalopathy, and Hepatorenal syndrome. Patients diagnosed with acutely decompensated cirrhosis were enrolled. Upon enrollment, detailed baseline data were collected and samples were harvested. Complications were assessed during hospitalization. Post-discharge follow-up was conducted through telephonic interviews at Day 30 and Day 90.

This is a multi-center, nested cohort study intended to investigate the prevalence, risk factors, and outcomes of complications in patients with acutely decompensated cirrhosis, especially focused on CMV reactivation, bacterial infections, hepatic encephalopathy, and Hepatorenal syndrome. Patients diagnosed with acute decompensated cirrhosis were enrolled. Upon enrollment, detailed baseline data were collected and samples including ascites, feces, plasma, urine and PBMC were harvested. Following enrollment, patients were subjected to a rigorous follow-up regimen extending over a period of 90 days. Complications were assessed every 3-4 days during hospitalization through a combination of laboratory and clinical evaluations. Post-discharge follow-up was conducted through telephonic interviews at Day 30 and Day 90. Upon the emergence of new complications, such as infections (viral, bacterial or fungal) or hepatic encephalopathy, a detailed, complication-specific protocol was activated (Per complications protocols as follows).

Special complications protocols:

Hepatic encephalopathy:

1. The feces, plasma, and urine were collected at hepatic encephalopathy diagnosis before treatment and at Day 4, 7, 14 since hepatic encephalopathy treatment. If patients were discharged before14 days post-hepatic encephalopathy, the sample at discharge were collocated;
2. The treatment strategy for HE is recorded;
3. The HE severity assessments were carried out daily.

CMV reactivation:

1. The patients' plasma were collected twice a week for the assessment of CMV reactivation; The patients' peripheral blood mononuclear cells (PBMC) samples were collected at baseline and at the time of diagnosis of CMV reactivation;
2. The treatment strategy for CMV is recorded.

Eligibility Criteria:
Inclusion Criteria:

* Informed written consent
* Age between 18 years and 80 years
* Cirrhosis based on liver histology or a combination of characteristic clinical, biochemical, and imaging features
* Complications of decompensated cirrhosis (ascites, gastrointestinal bleeding and hepatic encephalopathy)

Exclusion Criteria:

* Malignancy
* Acquired immune deficiency syndrome
* Received immunosuppressive drugs for non-hepatic reasons
* Received organ transplantations
The Therapeutic Use of Botulinum Toxin Type A in Subacute Cervical/Upper Back Pain

To determine the therapeutic efficacy of Botox not only for chronic cervical/upper back pain but also for subacute pain.

Subjects diagnosed with subacute (2-6 months post-onset) bilateral cervical/ upper back pain will be recruited in this double-blind control study.

A total of 30 subjects with subacute cervical/upper back pain will be recruited. If patients are qualified as participants and agreed to participate in the study by signing the consent form, they will be randomized into either (A) control group (injection of normal saline injection) or (B) study group (injection of BOTOX). The initial history taking step will include medical history including medication and surgery history, duration of pain, pre-injection neck disability index (NDI) and visual analogue scale (VAS) for pain. VAS score will be collected for 4 weeks before injection to ensure stable VAS, otherwise medical records will be reviewed to ensure stable feature of pain. Short Form (SF) -36 Health Survey will be used to assess functional status, and the Beck Depression Inventory (BDI) will be applied to assess psychological aspect. Physical examination will be performed to determine the most tender cervical/ upper back muscles, and rule out operative condition. A simple swallowing test (3-oz water swallowing test) will be applied for dysphagia screening.

The patients will be maintained with routine, standardized physical therapy, oral medication, and stretch exercise after the injection. NDI, VAS, and SF-36 questionnaire will be re-collected at 1, 2, 3, 4, and 6 months after the injection session.

Eligibility Criteria:
Inclusion Criteria:

* Male or female 18 y/o or greater,
* Subacute bilateral cervical/ upper back pain, pain of longer than 2 months and shorter than 6 months duration,
* VAS pain score of 5 or greater for the cervical/ upper back pain for 4 week period before injection,
* If female or child bearing potential, concurrent use of a reliable method of contraception.

Exclusion Criteria:

* Known allergy or sensitivity to Botulinum toxin type A.
* Any medical condition that may put the subject at increased risk with exposure to BOTOX®, including diagnosed myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral sclerosis, or any other significant disease that might interfere with neuromuscular function
* Use of aminoglycoside antibiotics, curare-like agents, or other agents that might interfere with neuromuscular function
* Pregnancy, breast feeding, or planned pregnancy
* Acute or operative pathology on cervical MRI
* History of treatment for gatro-esophageal reflux disease
* Abnormal finding on 3-oz water swallowing test on the initial screening visit
Comparison of Two Extubation Techniques in Critically Ill Adult Patients

Orotracheal extubation consists in the removal of the endotracheal tube (ETT) when it is no longer required. This procedure may carry a considerable risk of complications and extubation failure. The literature points out two methods of extubation: the traditional method and the positive pressure method.

In a noninferiority clinical trial it was demonstrated that EOT with positive pressure and without endotracheal suction was a safe technique and could be better than traditional extubation. Although prior studies reported better clinical outcomes with the positive pressure extubation technique, its superiority has not been deeply studied yet. Therefore, the objective of our study is to determine whether the positive pressure OTE technique, compared with the traditional OTE technique, reduces the incidence of major postextubation complications (up to 60 minutes) in critically ill adult patients.

Design: Multicenter randomized controlled clinical trial Methods: Critically ill adult subjects on invasive mechanical ventilation who met extubation criteria will be included. Will be randomly assigned to positive-pressure extubation (n=389) or to traditional extubation (n=389).

The main variable will be incidence of major complications.

Eligibility Criteria:
Inclusion Criteria:

* Age \>18
* Invasive mechanical ventilation through an endotracheal tube,
* Successfully complete a spontaneous breathing trial
* Adequate level of consciousness (Glasgow Coma Score \>8)
* Effective cough.
* Written informed consent from a relative or legal representative.

Exclusion Criteria:

* History of upper airway injury or surgery
* Previously extubated or tracheostomized
* Noninvasive ventilation (NIV) as a weaning method
* Decision to not reanimate