louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05886556: Validity of Lung Ultrasound in Diagnosis of Acute Respiratory Distress Syndrome
Official title: Validity of Lung Ultrasound in Diagnosis of Acute Respiratory Distress Syndrome and Prediction of Successful Weaning From Mechanical Ventilation in Those Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: of Lung Ultrasound in Diagnosis of Acute Respiratory Distress Syndrome
Keywords: lung ultrasound, acute respiratory distress syndrome
Lead sponsor: Zagazig University
Sponsor class: OTHER_GOV
First posted: 2023-06-02
Enrollment: 57
Sex: ALL
Minimum age (years): 19
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patients highly suspected to be ARDS admitted to ICU

Brief summary: To evaluate the validity of lung ultrasound compared to CT chest and chest radiograph for diagnosis of ARDS and prediction of successful weaning from mechanical ventilation in those patients compared to traditional methods.

Detailed description: 57 patients will be diagnosed as ARDS by CT chest and clinical criteria, then will be compared between the findings by lung ultrasound and chest radiograph to detect the sensitivity of both imaging to CT chest as gold standard in diagnosis of ARDS patients

Eligibility criteria: Inclusion Criteria:

Patients or legal guardian's consent .All patients with suspicious criteria of acute respiratory distress syndrome .Hemodynamically stable in the absence or minimal of vasopressors.

Exclusion Criteria:

Pregnant women. patients with traumatic lung injury or pneumothorax. surgical dressings over the right lower rib cage which would preclude ultrasound examination. presence of ascites. presence of lung collapse, fibrosis, or pleural effusion.

-presence of any mass or mechanical factor in the chest or the abdomen interfering with the diaphragmatic mobility.

Primary outcomes:
measure: diagnostic data checklist
timeFrame: immediately after ICU admission
Secondary outcomes:
measure: success rate
timeFrame: within 24 hours after weaning
measure: lung ultrasound as a predictor for weaning
timeFrame: immediately before weaning
measure: diaphragmatic ultrasound as a predictor for weaning
timeFrame: immediately before weaning
Other outcomes:
Locations:
city: Zagazig
country: Egypt
facility: Faculty of Medicine,Zagazig University
state: El Sharkia
Study officials:
affiliation: zagazig university faculty of human medicine
name: mona elharisy, M.D
role: STUDY_DIRECTOR
affiliation: zagazig university faculty of human medicine
name: Marwa M Medhat, M.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00683956: Evaluation of a Closed-Loop Control System for Administering Patient-Specific Anesthesia
Official title: Evaluation of a Closed-Loop Control System for Patient-Specific Induction and Maintenance of Propofol Hypnosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Anesthesia, General
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2008-05-26
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP

Brief summary: Numerous efforts have focused on the development of closed-loop systems to control anesthesia using the electrical activity of the brain (EEG) and EEG-based parameters as surrogate measures of anesthetic depth. New systems have been recently developed to considerably improve anesthetic control using model-based, patient-adaptive methods. The purpose of this study is to evaluate the clinical efficacy of a new intelligent software, ReinLoop, in delivering closed-loop, patient-specific hypnosis.


Eligibility criteria: Inclusion Criteria:

1. 18-45 years of age
2. Body mass index (BMI) lower or equal to 25 m2/kg
3. Subjects must be able to comprehend spoken and written English

Exclusion Criteria:

1. Any type of psychiatric, neurological, or neuromuscular disorder
2. Thyroid disease
3. History of smoking
4. Alcohol consumption which exceeds 2 drinks per day and /or drug abuse. Volunteers will be asked the question: How many drinks are you drinking on your typical day?
5. Allergy to study medication (propofol), soy, or egg proteins.
6. History of drug abuse
7. Chronic or acute use of opioids, or other medications affecting the CNS
8. Pregnancy

Primary outcomes:
measure: To evaluate the clinical efficacy of the ReinLoop agent in delivering closed-loop, patient-specific hypnosis.
Secondary outcomes:
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University School of Medicine
state: California
Study officials:
affiliation: Stanford University
name: Anthony Doufas
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04773756: Evaluation of Sofosbuvir and Daclatasvir Combo in COIVD-19 Patients in Egypt
Official title: Evaluation of Sofosbuvir and Daclatasvir Combo in COIVD-19 Patients in Egypt (Single Center Study)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Covid19
Keywords: Sofosbuvir
Daclatasvir
Lead sponsor: Alexandria University
Sponsor class: OTHER
First posted: 2021-02-26
Enrollment: 54
Sex: ALL
Minimum age (years): 12
Maximum age (years): 90
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Sofosbuvir has been recently recommended as a possible antiviral for COVID-19, based on structural studies and multiple alignment analysis. By comparing the positive-stranded RNA genomes of HCV and SARS-CoV-2, it has been postulated that sofosbuvir might be an optimal nucleotide analogue to repurpose for COVID-19 treatment


Eligibility criteria: Inclusion Criteria:

* mild- moderate COVID-19 confirmed by PCR

Exclusion Criteria:

1. Patients on renal dialysis
2. Severe COVID-19 cases
3. Patients on amiodarone therapy (given the reported FDA warning of an interaction between amiodarone and sofosbuvir that might lead to severe bradycardia).
4. Children \< 12 years
5. Pregnant and breast feeding women
6. Exacerbation of hepatitis B

Primary outcomes:
measure: evaluate the combined effect of Sofosbuvir and Daclatasvir in treatment of patients with mild-moderate Covid-19.
timeFrame: it is estimated to be 2 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Alexandria
country: Egypt
facility: Amr Aly Abd elmoety
Study officials:
affiliation: Alexandria University, Faculty of Medicine
name: Amr Abd elmoety, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01383915: Clinical Risk State for Bipolar Disorder in Adolescents
Official title: Characterizing the Clinical Risk State for Bipolar Disorder in Adolescents
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Bipolar Disorder
Schizophrenia
Lead sponsor: Northwell Health
Sponsor class: OTHER
First posted: 2011-06-28
Enrollment: 402
Sex: ALL
Minimum age (years): 12
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Inpatients consecutively admitted to the adolescent inpatient unit of the Zucker Hillside Hospital, NY

Brief summary: Aim: The purpose of the study is to characterize the at-risk phases preceding a first episode of bipolar disorder and of schizophrenia, and to identify clinical and biological predictors of the disease development.

Hypothesis a: Over 6-24 months, 25% of at-risk youth will develop the full manifestations of Bipolar Disorder (BPD) or schizophrenia.

Hypothesis b: The symptoms utilized for characterizing the at-risk phase of BPD will differentiate between individuals developing BPD and schizophrenia.

Detailed description: Prospective, naturalistic, cohort study aiming to characterizing the bipolar and psychotic prodrome thoroughly with a variety of clinical and biological measures.

Eligibility criteria: Inclusion Criteria:

1. Age: 12-18 years;
2. Sex: male or female;
3. Race/ethnicity: no restrictions;
4. Definite or suspected chart diagnosis of BP-II, BP-NOS, cyclothymia, MDD, depressive disorder NOS, dysthymia or mood disorder NOS, schizophrenifiorm disorder or psychotic disorder NOS;
5. Subject and parent (if subject\<18) willing and able to provide written, informed consent/assent.

Exclusion Criteria:

1. Estimated Premorbid IQ \< 70;
2. Meets DSM-IV criteria for BP-I or schizophrenia, pervasive developmental disorder, autism spectrum disorders, current substance dependence;
3. History of medical condition known to affect the brain;
4. current group home affiliation.

Primary outcomes:
measure: Number of subjects with development of a bipolar or schizophrenia disorder
timeFrame: within 60 months
Secondary outcomes:
measure: Psychopathology
timeFrame: within 60 months
Other outcomes:
Locations:
city: Glen Oaks
country: United States
facility: The Zucker Hillside Hospital, NSLIJ
state: New York
Study officials:
affiliation: The Zucker Hillside Hospital, Feinstein Institute for Medical Research
name: Christoph Correll, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Gerstenberg M, Hauser M, Al-Jadiri A, Sheridan EM, Kishimoto T, Borenstein Y, Vernal DL, David L, Saito E, Landers SE, Carella M, Singh S, Carbon M, Jimenez-Fernandez S, Birnbaum ML, Auther A, Carrion RE, Cornblatt BA, Kane JM, Walitza S, Correll CU. Frequency and correlates of DSM-5 attenuated psychosis syndrome in a sample of adolescent inpatients with nonpsychotic psychiatric disorders. J Clin Psychiatry. 2015 Nov;76(11):e1449-58. doi: 10.4088/JCP.14m09435.
Clinical trial NCT04029415: The Study of the Antimicrobial Resistance of Helicobacter Pylori in Shandong Province
Official title: The Study of the Antimicrobial Resistance of Helicobacter Pylori in Shandong Province
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Helicobacter Pylori
Keywords: antimicrobial resistance
Lead sponsor: Shandong University
Sponsor class: OTHER
First posted: 2019-07-23
Enrollment: 1800
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The patients in Shandong province, aged between 18 and 70 years old, with positive H. pylori infection that was not eradicated by previous therapies are included.

Brief summary: The antimicrobial resistance of helicobacter pylori in Shandong province was analyzed by helicobacter pylori antibiotic sensitivity test.And the map of antimicrobial resistance of helicobacter pylori was constructed to provide clinical guidance for selecting effective eradication program and improve the eradication rate.

Detailed description: The patients with positive H. pylori infection that was not eradicated by previous therapies will accept the gastroscopy. The mucosa of the lesser curvature of gastric antrum and the greater curvature of the stomach will progress helicobacter pylori antibiotic sensitivity test to detect the antimicrobial resistance of helicobacter pylori.The antimicrobial resistance of helicobacter pylori in Shandong province will be described by frequency and percentage.

Eligibility criteria: Inclusion Criteria:

* Patients, aged between 18 and 70 years old, with positive H. pylori infection that was not eradicated by previous therapies are included. The H. pylori infection is confirmed by the positive rapid urease test or 13C-breath test.

Exclusion Criteria:

* Patients with significant underlying disease including liver, cardiac, pulmonary, and renal diseases, neoplasia, coagulopathy and genetic diseases, history of gastric surgery, pregnancy, breast-feeding, active gastrointestinal bleeding, the use of PPI, NSAID or antibiotics during the 4 weeks prior to enrolment, and previous history of allergic reactions to any of the medications used in this protocol. Patients previously treated with H. pylori eradication regimens or those unwilling to participate in the study were also excluded.

Primary outcomes:
measure: Antimicrobial resistance rate
timeFrame: 3years
Secondary outcomes:
measure: The influence factors of the antimicrobial resistance rate
timeFrame: 3years
Other outcomes:
Locations:
city: Jinan
country: China
facility: Qilu Hospital of Shandong University
state: Shandong
Study officials:
affiliation: Qilu Hospital of Shandong University
name: Xiuli Zuo, MD,PhD
role: STUDY_CHAIR
affiliation: Qilu Hospital of Shandong University
name: Tian Ma, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05814315: Harnessing Online Peer Education Opioid Study
Official title: Opioid Support and Risk Reduction Online Platform
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Medication Compliance
Pain
Lead sponsor: ElevateU
Sponsor class: INDUSTRY
First posted: 2023-04-14
Enrollment: 67
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The investigators have created an online peer support platform for chronic pain patients on opioid medications. This platform provides peer support and online mental health counselor run support groups to help participants manage pain and not abuse opioid medications.

Detailed description: This study determined the feasibility, acceptability, and preliminary efficacy of an online support and risk reduction platform to prevent opioid misuse and abuse. This is an urgent area of research; opioid misuse/abuse has reached epidemic proportions in recent years. It is linked to causing the largest drug epidemic in the history of the United States and has become the top priority of the US Surgeon General. Because the opioid crisis (including heroin use) is believed to have largely originated from chronic pain patients' opioid prescriptions, this application will initially focus on the needs of chronic pain patients on opioids who are high risk for addiction and overdose. Later versions of the technology will expand to the broader population of people affected by the opioid crisis, including heroin users.

Although low cost, novel interventions are needed to reduce opioid misuse and abuse, before they lead to addiction and fatal overdose, only 6 behavioral (non-pharmacological) randomized controlled trials have been successfully conducted in this area to date (with our group having conducted one of them), creating a tremendous need for solutions to the opioid crisis. Building off extensive preliminary research that our team conducted, including piloting technology-based behavior change interventions among chronic pain patients, and developing artificial intelligence (AI)-based prediction models of opioid outcomes, we propose to design and test the feasibility, acceptability, and preliminary efficacy of an online peer social support and clinical counseling community to reduce opioid misuse/abuse among chronic pain sufferers.

Eligibility criteria: Inclusion Criteria: adults over 18, COMM scores at risk of misuse, prescribed opioids by doctor -

Exclusion Criteria: cancer patients, elicit drug users, under 18 years

-

Primary outcomes:
measure: Generalized Anxiety Disorder scale 7 scores
timeFrame: 12 weeks
Secondary outcomes:
measure: Beck Depression Inventory scores
timeFrame: 12 weeks
measure: Current Opioid Misuse Measure scores
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Corona Del Mar
country: United States
facility: ElevateU
state: California
Study officials:
References:
Clinical trial NCT00568815: Rituximab Combined With ESHAP in Patients With Relapse or Refractory Diffuse Large B Cell Lymphoma (DLBCL)
Official title: Phase II Study of Rituximab Combined With ESHAP in Patients With Relapse or Refractory DLBCL
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Lymphoma
Keywords: DLBCL
Rituximab
ESHAP
Efficacy
Toxicity
Lead sponsor: Fudan University
Sponsor class: OTHER
First posted: 2007-12-06
Enrollment: 31
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the efficacy and toxicity of Rituximab combined with ESHAP (etoposide, methylprednisolone, cytarabine, and cisplatin) in the patients with diffuse large B cell lymphoma (DLBCL).

Detailed description: The salvage therapy in the patients with DLBCL is still controversial. The investigators conducted this study to evaluate the efficacy and tolerability of Rituximab combined with ESHAP in the patients with DLBCL. The patients enrolled were defined to be relapsed or refractory after the first-line chemotherapy like CHOP or other CHOP-like regimens.

Eligibility criteria: Inclusion Criteria:

* Age range 18-70 years old
* Histological confirmed diffuse large B cell lymphoma
* ECOG performance status no more than 2
* Life expectancy of more than 3 months
* Relapse or refractory after the first-line chemotherapy of DLBCL
* No evidence of bone marrow involvement
* Normal laboratory values: hemoglobin \> 8.0g/dl, neutrophil \> 1.5×109/L, platelet \> 80×109/L, serum creatine \< 1× upper limitation of normal(ULN), serum bilirubin \< 1× ULN, ALT and AST \< 1.5× ULN

Exclusion Criteria:

* Pregnant or lactating women
* Serious uncontrolled diseases and intercurrent infection
* The evidence of CNS metastasis and bone marrow involvement
* History of other malignancies except cured basal cell carcinoma of skin and carcinoma in-situ of uterine cervix
* History of allergic reaction/hypersensitivity to rituximab

Primary outcomes:
measure: Response rate
timeFrame: 6 weeks
Secondary outcomes:
measure: Toxicities
timeFrame: every cycle
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Fudan University Cancer Hospital
state: Shanghai
Study officials:
affiliation: Fudan University
name: Biyun Wang, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06056115: Efficacy and Safety of Tislelizumab for Lung Adenocarcinoma With Asymptomatic Brain Metastatic
Official title: Efficacy and Safety of Tislelizumab Combined With Platinum-containing Drug Chemotherapy in First-line Treatment of Lung Adenocarcinoma With Asymptomatic Brain Metastatic
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Lung Adenocarcinoma
Lead sponsor: Hebei Medical University Fourth Hospital
Sponsor class: OTHER
First posted: 2023-09-28
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Brain metastasis of lung cancer is one of the most important metastasis pathways in patients with life-threatening diseases. This study explore the efficacy and safety of Tislelizumab combining with platinum-containing drug chemotherapy in the first-line treatment of Lung Adenocarcinoma With Asymptomatic Brain Metastatic. Meanwhile, Related biomarkers were explored to provide theoretical basis for efficacy evaluation and resistance mechanism.


Eligibility criteria: Inclusion Criteria:

1. Patients with metastatic (stage IV) lung adenocarcinoma who have not been systematically treated and are histologically or cytologically confirmed as unable to undergo radical surgery or radiotherapy based on AJCC Stage VIII;
2. Patients with brain metastases confirmed by imaging;
3. Patients with asymptomatic BMS after initial diagnosis, local BMS surgery or radiotherapy;
4. ECOG PS: 0-1;
5. Measurable target lesions outside the skull (as per RECIST 1.1);
6. Life expectancy greater than 3 months;

Exclusion Criteria:

1. Patients had been treated with immune checkpoint inhibitors such as anti-PD-1, PD-L1, or CTLA-4 therapy;
2. The patient had received systemic chemotherapy as advanced treatment;
3. Patients with EGFR mutation or ALK gene translocation;
4. The patient had received approved systemic anticancer therapy or systemic immunomodulators (including but not limited to interferon, interleukin 2, and tumor necrosis factor) within 4 weeks prior to initial administration;
5. Clinically uncontrolled pleural fluid or ascites requiring puncture drainage within 2 weeks prior to initial administration;

Primary outcomes:
measure: 1 years PFS
timeFrame: up to 1year
Secondary outcomes:
measure: The objective response rate (ORR)
timeFrame: Through study completion, an average of 12 months
Other outcomes:
Locations:
city: Shijiazhuang
country: China
facility: The Fourth Hospital of Hebei Medical University (Hebei Tumor Hospital)
state: Hebei
Study officials:
affiliation: The Fourth Hospital of Hebei Medical University (Hebei Tumor Hospital)
name: Jian Shi, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04212715: Prostate SABR With Intra-Prostatic SABR Boost
Official title: Prostate SABR With Intra-Prostatic SABR Boost: A Phase II Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Prostate Cancer
Lead sponsor: King Saud University
Sponsor class: OTHER
First posted: 2019-12-27
Enrollment: 30
Sex: MALE
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Stereotactic Ablative Radiation (SABR/SBRT) will be prescribed to a dose of 35 Gy in 5 fractions, once weekly to prostate with a simultaneous intra-prostatic boost to the MR detected nodule up to 50Gy. The pelvic lymph nodes and seminal vesicles will also receive 25 Gy in 5 weekly fractions.


Eligibility criteria: Inclusion Criteria:

* Histologically confirmed prostate adenocarcinoma
* High-risk prostate cancer, defined as at least one of: T3, Gleason 8-10, OR PSA \> 20 ng/mL
* Willing to give informed consent to participate in this clinical trial

Exclusion Criteria:

* Prior pelvic radiotherapy
* Contraindication to radical prostate radiotherapy e.g. connective tissue disease or inflammatory bowel disease
* Contraindication to prostate MRI
* No evidence of castrate resistance (defined as PSA \< 3 ng/ml while testosterone is \< 0.7nmol/l. Patients could have been on combined androgen blockade but are excluded if this was started due to PSA progression.
* Definitive extrapelvic nodal or distant metastatic disease on staging investigations.

Primary outcomes:
measure: Acute Toxicity
timeFrame: 3 month after accrual is completed
Secondary outcomes:
Other outcomes:
Locations:
city: Riyadh
country: Saudi Arabia
facility: King Saud University Medical City
Study officials:
affiliation: King Saud Medical City
name: Yasir Alayed, MD
role: PRINCIPAL_INVESTIGATOR
References: