louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04988542: Clinical Efficacy of a Supplement on Sleep Quality
Official title: Clinical Efficacy of a Novel Delivery Supplement on Sleep Quality
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Sleep
Lead sponsor: TruDiagnostic
Sponsor class: INDUSTRY
Collaborators: name: Circadian Wellness Corp
First posted: 2021-08-03
Enrollment: 30
Sex: ALL
Minimum age (years): 16
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Patients will be in the control group for 1 month and in the intervention group for one month
Primary purpose: OTHER

Brief summary: This is a prospective randomized clinical study of 30 patients to evaluate a novel sleep supplement. This study will be evaluating the effectiveness of the supplement over a 2 month program. The study will assess the effects that the supplement has on a patient's sleep metrics and epigenetic age biomarkers.


Eligibility criteria: Inclusion Criteria:

* Men and women of any ethnicity.
* Age Range - 16 - 65
* Patient must be able to comply with treatment plan and laboratory tests

Exclusion Criteria:

* Neoplastic cancer within 5 years prior to screening, except for cutaneous basal cell or squamous cell cancer resolved by excision
* No immune system issues or immunodeficiency disease
* No history of viral illness which could be reactivated by immune downregulation
* Presence of clinically significant acute or unstable cardiovascular and cerebrovascular (stroke)
* Diagnosis of a transient ischemic attack in the 6 months prior to screening
* Patients infected with hepatitis, C or HIV
* Patients with Body Mass Index (BMI) \> 40 kg/m2
* Presence of active infection
* Any other illness, psychiatric disorder, alcohol or chemical dependence that in the opinion of the investigator would render a patient unsuitable to participate in the study
* Unable or unwilling to provide required blood sample for testing
* As for the male-participants they are recommended to avoid fertilization for the first 6 months after the clinical trial.
* If the patient has previously used any products in a month prior to the start of the trial.
* Known sleep disorder ie. obstructive sleep apnea
* Presence of schizophrenia, bipolar disorder
* Concurrent use of cannabis

Primary outcomes:
measure: Epigenetic Age
timeFrame: Change from baseline to 2 months
Secondary outcomes:
measure: Sleep duration
timeFrame: change from baseline to 2 months
Other outcomes:
Locations:
Study officials:
affiliation: Peak Human Labs
name: Sanjeev Goel
role: PRINCIPAL_INVESTIGATOR
References:
citation: Cui XY, Cui SY, Zhang J, Wang ZJ, Yu B, Sheng ZF, Zhang XQ, Zhang YH. Extract of Ganoderma lucidum prolongs sleep time in rats. J Ethnopharmacol. 2012 Feb 15;139(3):796-800. doi: 10.1016/j.jep.2011.12.020. Epub 2011 Dec 21.
Clinical trial NCT05612542: Pediatric Cardiac Surgery Comparing Short 24-hour Antibiotic Prophylaxis to Extended Antibiotic Prophylaxis
Official title: Non-inferiority Study in Pediatric Cardiac Surgery Comparing Short 24-hour Antibiotic Prophylaxis to Extended Antibiotic Prophylaxis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Antibiotic Prophylaxis
Keywords: Antibiotic Prophylaxis
Bacterial proliferation
Bacterial infections
Postoperative infection
Pediatric cardiac surgery
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2022-11-10
Enrollment: 400
Sex: ALL
Minimum age (years): 0
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Minor patient, under 18 years of age, operated for cardiac surgery at the University Hospital of Strasbourg between January 2015 and June 2019, by sternal approach (sternotomy)

Brief summary: The objective of antibiotic prophylaxis is to prevent bacterial proliferation in order to reduce the risk of postoperative infection.

Numerous recent recommendations show a benefit of a reduced duration of antibiotic prophylaxis in surgery, particularly in pediatrics.

The study focuses on the incidence of postoperative infection by comparing antibiotic prophylaxis with 2nd generation cephalosporin (G2G) for 48 hours to a short antibiotic prophylaxis protocol limited to 24 hours.

The bacterial infections considered were those said to be care-related, according to the criteria of the French Society of Anesthesia and Intensive Care if they occurred within the 3 months postoperative interval and were not present before the surgery:

* sepsis
* superficial or deep surgical site infection (mediastinitis, sternitis, scar infection)
* catheterization infection,
* urinary tract infection or
* respiratory infection such as pneumopathy acquired under mechanical ventilation

The hypothesis is that reducing the duration of antibiotic prophylaxis does not expose patients to an increased risk of infection and limits exposure to antibiotics


Eligibility criteria: Inclusion criteria:

* Child less than 18 years of age,
* Operated for cardiac surgery at the University Hospital of Strasbourg between January 2015 and June 2019, by sternal approach (sternotomy),
* Child and holders of parental authority who have not expressed, after information, their objections to the reuse of his for the purpose of this research.

Exclusion criteria:

* Child who has undergone thoracic heart surgery (thoracotomy),
* Child with an infection at the time of heart surgery,
* Child and parental authority holders who have expressed their objections to participating in this research

Primary outcomes:
measure: Number of postoperative care-related infections in cardiac surgery
timeFrame: 24 hours after antibiotic prophylaxis
Secondary outcomes:
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Service réanimation pédiatrique médico-chirurgicale spécialisée - CHU de Strasbourg - France
Study officials:
References:
Clinical trial NCT03611842: Study of the Expression of MMPs in OME in Children With Atrophy of the Eardrum
Official title: Study of the Expression of MMPs (Metalloproteinase Matricial) in OME (Otitis Media With Effusion) in Children Under Twelve Years Old With Atrophy of the Eardrum
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Otitis Media With Effusion
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
Collaborators: name: INM : institut des neurosciences Montpellier
First posted: 2018-08-02
Enrollment: 35
Sex: ALL
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Children under the age of twelve with OME and surgical indication for myringostomy of tube placement

Brief summary: Metalloproteinases (MMPs) constitute a family of endopeptidases that cleaves the extracellular matrix as collagen included in the eardrum. Activity of MMP has been shown in some otitis media with effusion (OME) fluids. These enzymes could be directly linked to the prosnostic of OME as it may damage the eardrum and leads to tympanic atrophy.

The main goal of the study is to find out the correlation between activity of MMPs and tympanic atrophy. The investigator will also study if there is any clinical predictive factors in relation to the level of MMPs.

Detailed description: The investigator will include 35 children under 12 years old with OME and who need tympanostomy or tube placement under general anesthesia. Middle ear effusion will be collected, divided in two and frozen.

The investigator will perform ELISA tests to measure the level of MMP2 MMP9 MMP7 et TIMP2 (inhibitor of MMPs). The investigator want to compare the level of MMPs between healthy eardrum and atrophic membrane.

Clinical data will be collected such as age, gender, chronicity of the OME, quality of the eardrum and middle ear effusion type to see if there is any difference when MMPs level is higher.

Eligibility criteria: Inclusion Criteria:

- every children under 12 yo operated on in Gui de Chauliac Hospital

Exclusion criteria:

- when effusion is not possible to collect (too thick or amount of fluid not enough)

Collection of both MEE on each ear when OME is bilateral. We will perform the tests on only one ear. The other one will be kept in case of technical issue. A random draw will establish which ear will be tested.

Primary outcomes:
measure: Microscopic evaluation of the quality of the eardrum : normal or atrophic
timeFrame: before surgery
Secondary outcomes:
measure: biochemical assay of the level of TIMP
timeFrame: 1 day
measure: biochemical assay of the level of MMPs
timeFrame: 1 day
Other outcomes:
Locations:
city: Montpellier
country: France
facility: Uhmontpellier
Study officials:
affiliation: University Hospital, Montpellier
name: Lylou Casteil Baume, ENT resident
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05647642: The Effect of Premedication on Postoperative Pain and Anxiety in Breast Cancer Surgery
Official title: The Effect of Premedication Methods to be Applied to Prevent Preoperative Anxiety in Patients Who Will be Operated for Breast Cancer, on Postoperative Anxiety and Pain
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Female Patients Under the Age of 65 Who Will Undergo Breast Cancer Surgery
Lead sponsor: Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital
Sponsor class: OTHER
First posted: 2022-12-12
Enrollment: 80
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: ASA 1-2-3, female patients aged 18-65 who will undergo breast cancer surgery

Brief summary: In this study, it was investigated whether the premedication drug administered before the surgery had an effect on postoperative pain and anxiety scores in female patients under the age of 65 who will undergo breast cancer surgery.

Detailed description: In this study, it was investigated whether the premedication drug administered before the surgery had an effect on postoperative pain and anxiety scores in female patients under the age of 65 who will undergo breast cancer surgery. The STAI-1(State Trait Anxiety İnventory ) form and APAIS (Amsterdam Preoperative Anxiety and İnformation Scale) scale were filled in for all preoperative patients. Afterwards, the patients were treated with either midazolam or dexmedetothymidine, depending on the anesthesiologist's preference. After administration, he was taken to surgery. As intraoperative analgesics, 2 mg/kg tramadol and 15 mg/kg paracetamol were administered to all patients. postoperative recovery time (aldrete 10), 1., 2.,6.,12.,24. VAS score, postoperative nausea-vomiting scale, STAI-1(State Trait Anxiety İnventory ) form, first need time if postoperative analgesic was needed, and 24-hour total analgesic consumption were recorded. It was aimed to examine the effects of different premedications on postoperative pain and anxiety

Eligibility criteria: Inclusion Criteria:

* ASA 1-2-3
* 18-65 aged
* Female patients

Exclusion Criteria:

* Under 18 years old and over 65 years old
* Having a history of cerebrovascular disease illiteracy
* Have visual and auditory problems İnability to cooperate with cognitive function test
* Having emergency surgery
* Those who are unable to read, understand and sign the consent form
* Patients deemed unsuitable by the investigator

Primary outcomes:
measure: effect of premedication on postoperative pain and anxiety scores
timeFrame: November 2022-December 2022
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: AbdurrahmanYAOTRH
Study officials:
References:
Clinical trial NCT05148442: A Study Evaluating the Safety, Tolerability and Preliminary Efficacy of IBI322 in Subjects With Myeloid Tumor
Official title: A Phase Ia/Ib Study Evaluating the Safety, Tolerability and Preliminary Efficacy of IBI322 in Subjects With Myeloid Tumor
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Myeloid Tumor
Lead sponsor: Innovent Biologics (Suzhou) Co. Ltd.
Sponsor class: INDUSTRY
First posted: 2021-12-08
Enrollment: 1
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a phase I study evaluating the safety, tolerability and preliminary efficacy of IBI322 in Myeloid tumor patients.

Detailed description: Phase 1a/1b study will be conducted to evaluate the tolerability, safety, PK, PD, immunogenicity and preliminary antitumor activity of IBI322 in patients with myeloid tumor. Phase 1a is the dose escalation part of the study and Phase 1b is the dose expansion part. Combination therapy with HMA(Azacitidine or Decitabine) will be evaluated.

Eligibility criteria: Inclusion Criteria:

1. Patients who met the diagnostic criteria of recurrent / refractory AML (WHO 2016)(primordial cells in bone marrow ≥ 5%) (excluding APL and bcr-abl positive AML ) and underwent treatment.
2. Patients who meet the diagnostic criteria of recurrent / refractory MDS (WHO 2016)and underwent treatment.
3. Patients with recurrent / refractory Essential thrombocythemia (WHO2016) after treatment (for Phase Ia)
4. Male or female subject above 18 years old
5. Eastern Cooperative Oncology Group Performance Status (ECOG PS) performance status 0 \~ 2.
6. Must have adequate organ function

Exclusion Criteria:

1. Previous history with myeloproliferative Neoplasms(MPN) or MDS/MPN
2. Transformation or treatment related AML/MDS.
3. PV/MF/AML/MDS evolved from Essential thrombocythemia
4. Relapse after allogeneic hematopoietic stem cell transplantation, or autologous hematopoietic stem cell transplantation within 1 year
5. Central nervous system leukemia infiltration
6. Previous history of chronic hemolytic anemia or screening Coombe test positive
7. Previous exposure to any anti-CD47 monoclonal antibody, SIRPα antibody, or CD47/SIRPα recombinant protein.
8. Previous exposure to chimeric antigen receptor T cell immunotherapy (CAR-T)
9. Patients who received immunotherapy, targeted therapy, biological therapy or any clinical research treatment within 14 days before receiving the first dose
10. Uncontrolled concurrent diseases
11. Subjects who are allergic to the ingredients of the study drug
12. Subjects who have used immunosuppressive drugs within 7 days before the first dose of study treatment

Primary outcomes:
measure: Number of treatment related AEs
timeFrame: Up to 90 days post last dose
Secondary outcomes:
measure: Number of patients with response
timeFrame: Last patient enrolled+24 weeks
Other outcomes:
Locations:
city: Suzhou
country: China
facility: The first affiliated hospital of soochow university
state: Jiangsu
Study officials:
References:
Clinical trial NCT01043042: Identification of Inpatients at Risk for Poor Glycemic Control
Official title: Identification of Inpatients at Risk for Poor Glycemic Control
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hypoglycemia
Hyperglycemia
Keywords: hypoglycemia among inpatients
hyperglycemia among inpatients
Lead sponsor: Vanderbilt University Medical Center
Sponsor class: OTHER
First posted: 2010-01-06
Enrollment: 33011
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Candidates for inclusion will include all adult (age ≥ 18 years) patients admitted to Vanderbilt University Medical Center from 04/01/2008 to 10/31/2009. Patients will be excluded if they were pregnant at the time of admission or had length of stay \< 24 hours.

Brief summary: Both hypoglycemia and hyperglycemia can be detrimental to hospitalized patients. However, it is not clear which patients are more likely to develop significant problems with hypoglycemia or severe hyperglycemia in the hospital. Our hypothesis is that we will be able to identify risk factors present at admission that identify patients at greater risk of poor inpatient glycemic control


Eligibility criteria: Inclusion Criteria:

* age ≥ 18 years
* hospitalized in VUH

Exclusion Criteria:

* -length of stay \< 24 hours
* pregnant women
* patients receiving palliative/hospice care

Primary outcomes:
measure: hypoglycemia or hypoglycemia
timeFrame: during hospitalization
Secondary outcomes:
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Vanderbilt University Hospital
state: Tennessee
Study officials:
affiliation: Vanderbilt University
name: Jeffrey Boord, MD MPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06041542: Evaluation of the Screening Effect of Artificial Intelligence Hand Activity Evaluation System for Cervical Spondylosis
Official title: Evaluation of the Screening Effect of Artificial Intelligence Hand Activity Evaluation System for Cervical Spondylosis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: 10-second G&R Test
Keywords: 10-second G&R test
cervical spondylotic myelopathy
hand motion analysis
video analysis
Lead sponsor: Guangdong Provincial People's Hospital
Sponsor class: OTHER
First posted: 2023-09-18
Enrollment: 1380
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 1000 asymptomatic population in community; 200 cases of cervical spondylosis; Arthritis, Parkinson's disease, cerebral apoplexy 60 patients each.

Brief summary: The purpose of this study:

1. Build an artificial intelligence screening tool for cervical spondylosis based on hand function analysis;
2. Verify the accuracy of cervical spondylosis screening tools.

Detailed description: Cervical spondylotic myelopathy (CSM) has a high incidence in the middle-aged and elderly people. According to clinical research, the surgeon can makes a preliminary assessment of the severity of CSM based on a 10-second grip and release (G\&R) test. The statistics of G\&R test mainly rely on the surgeon's manual counting. When a patient's hand motion speed is too fast, the surgeon's manual counting is prone to error, leading to potential misdiagnosis. We construct and verify the intelligent video analysis system for Grip-\&-release. The system has a high accuracy and inference speed that ensure the proposed model can be used as a screening examination tool for CSM and a medical assistance tool to help decision making during CSM treatment planning.

Eligibility criteria: Inclusion Criteria:

1. Age between 18-80 years old;
2. Patients who have received cervical CT or MR examination within the last month and have been clearly diagnosed or excluded from cervical spondylosis (i.e., those who have been clearly diagnosed before participating in the study);
3. People who are willing to participate in the study with CT/MR examination (i.e., those who have not been diagnosed before joining the study).

Exclusion Criteria:

1. Subjects with cervical spondylosis who have been examined but still cannot be definitively diagnosed or ruled out;
2. Subjects with definite presence of hand trauma;
3. People who do not have access to CT or MR;
4. Subjects who did not comply with the examination, were unable to perform neurological assessment, or were unable to fill out questionnaires.

Primary outcomes:
measure: mJOA score
timeFrame: 2022-10-01-2022-12-30
Secondary outcomes:
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Guangdong Provincial People's Hospital
state: Guangdong
Study officials:
affiliation: Guangdong Provincial People's Hospital
name: Yunbing Chang, M.D.
role: STUDY_CHAIR
References:
Clinical trial NCT05632042: Response of Metabolic Syndrome and Sexual Dysfunction to Lifestyle Changes in Men With Psoriasis
Official title: Response of Metabolic Syndrome and Sexual Dysfunction to Lifestyle Changes/Modifications in Men With Psoriasis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Psoriasis
Metabolic Syndrome
Erectile Dysfunction
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2022-11-30
Enrollment: 60
Sex: MALE
Minimum age (years): 35
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: complaint of sexual dysfunction and metabolic syndrome are highly reported in men with psoriasis

Detailed description: erectile dysfunction (ED) psoriatic men with metabolic syndrome (number of the patients will be 60) will assigned to study group (group = 30 patients) that will receive lifestyle changes (12 weeks of low calorie diet and moderate-intensity walking on treadmill, the walking duration will be 40 minutes, the walking will be three times per week) or control group (group=30 patients) that will receive no lifestyle changes/modifications.

Eligibility criteria: Inclusion Criteria:

* psoriatic married men with metabolic syndrome and erectile dysfunction

Exclusion Criteria:

* patients with heart, respiratory, other autoimmune problems

Primary outcomes:
measure: International Index of Erectile Function
timeFrame: It will be measured after 12-week intervention
Secondary outcomes:
measure: psoriasis area and severity index
timeFrame: It will be measured after 12-week intervention
measure: body mass index
timeFrame: It will be measured after 12-week intervention
measure: systolic blood pressure
timeFrame: It will be measured after 12-week intervention
measure: diastolic blood presure
timeFrame: It will be measured after 12-week intervention
measure: waist circumference
timeFrame: It will be measured after 12-week intervention
measure: blood glucose
timeFrame: It will be measured after 12-week intervention
measure: triglycerides
timeFrame: It will be measured after 12-week intervention
measure: high density lipoprotein
timeFrame: It will be measured after 12-week intervention
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: Cairo Unoversity
Study officials:
affiliation: Cairo University
name: Ali Ismail, lecturer
role: PRINCIPAL_INVESTIGATOR
References: