louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05752123: A Study to Evaluate the Safety and Efficacy of ET-01 Transplantation in Subjects with Transfusion Dependent Β-Thalassaemia.
Official title: A Single Site, Open Label Study to Evaluate the Safety and Efficacy of ET-01 Transplantation in Subjects with Transfusion Dependent Β-Thalassemia
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Transfusion Dependent Beta-Thalassaemia
Lead sponsor: EdiGene (GuangZhou) Inc.
Sponsor class: INDUSTRY
Collaborators: name: The 923rd Hospital of Joint Logistics Support Force of People's Liberation Army
First posted: 2023-03-02
Enrollment: 2
Sex: ALL
Minimum age (years): 6
Maximum age (years): 35
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is an open label, single site study to evaluate the safety and Efficacy of ET-01 Transplantation in subjects with Transfusion Dependent β-Thalassaemia.


Eligibility criteria: Key Inclusion Criteria:

* Subject and/or subject's legal personal representative fully understand and voluntarily sign informed consent forms;
* 6\~35 years old, all gender;
* Diagnosis of transfusion dependent β-thalassemia (β-TDT) as defined by protocol;
* Eligible for autologous stem cell transplant;
* Organs in good function.

Other protocol defined Inclusion criteria may apply.

Key Exclusion Criteria:

* Subjects with associated α-thalassemia;
* Active bacterial, virus, fungal or parasitic infection, including HIV infection, HbsAg and HBV DNA positive, HCV DNA positive, or Treponema Pallidum infection;
* HLA identical sibling or unrelated donors are available;
* Prior allo-HSCT or gene therapy.

Other protocol defined Exclusion criteria may apply.

Primary outcomes:
measure: Frequency and severity of AEs & SAEs identified according to NCI CTCAE 5.0.
timeFrame: From ET-01 infusion to 104 weeks post-transplant
measure: All-cause mortality.
timeFrame: From signing of informed consent to 104 weeks post-transplant
measure: Incidence of transplant-related mortality.
timeFrame: within 100 days post-transplant
measure: Proportion of subjects with engraftment.
timeFrame: up to 42 days post-transplant
Secondary outcomes:
measure: Change in total hemoglobin from baseline.
timeFrame: within 104 weeks post-transplant
measure: Change of HbF from baseline.
timeFrame: within 104 weeks post-transplant
measure: Change of proportion of HbF/Hb.
timeFrame: within 104 weeks post-transplant
measure: Change of frequency of packed RBC transfusions.
timeFrame: From 6 months before recruitment to 104 weeks post-transplant
measure: Change of volume of packed RBC transfusions.
timeFrame: From 6 months before recruitment to 104 weeks post-transplant
Other outcomes:
Locations:
city: Nanning
country: China
facility: PLA 923 Hospital
state: Guangxi
Study officials:
References:
Clinical trial NCT00168623: Vitamin A Supplementation With Routine Childhood Vaccines and Mortality and Morbidity
Official title: Randomised Trial of Vitamin A Supplementation Given With Routine Childhood Vaccines at National Immunisation Days
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Mortality
Morbidity
Keywords: Vitamin A
Vaccines
Mortality
Morbidity
Lead sponsor: Bandim Health Project
Sponsor class: OTHER
First posted: 2005-09-15
Enrollment: 6200
Sex: ALL
Minimum age (years): 6
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Vitamin A supplementation (VAS) is important for the immune system and may interact with different childhood vaccinations. We have hypothesized that the improved survival after VAS may depend on vitamin A amplifying the non-specific immune modulation induced by vaccinations.

In the present study we used information collected in connection with a national vitamin A campaign in Guinea-Bissau during which different doses of VAS was provided together with missing doses of DTP, OPV, and measles vaccines. We aimed to study the potential interactions between VAS and vaccine type.

Detailed description: Vitamin A supplementation (VAS) acts as an adjuvant to vaccines, and VAS has been shown to enhance both cellular and humoral immune responses in animals and in humans. Routine childhood vaccinations have recently been shown to have important non-targeted effects on mortality, i.e. effects that cannot be explained merely by the prevention of the targeted disease. We have hypothesized that the improved survival after VAS may depend not only on the prevention of vitamin A deficiency, but also on vitamin A amplifying the non-specific immune modulation induced by routine vaccinations.

In the present study we used information collected in connection with a national vitamin A campaign in Guinea-Bissau during which different doses of VAS was provided together with missing doses of DTP, OPV, and measles vaccines. We aimed to study the potential interactions between VAS and vaccine type.

Eligibility criteria: Inclusion Criteria:Between 6 months and 5 years and thus eligible for vitamin A and missing vaccines during national immunisation days -

Exclusion Criteria: Overt signs of vitamin A deficiency

-

Primary outcomes:
measure: Mortality
measure: Morbidity
measure: Both outcomes analysed according to vaccine received and sex
Secondary outcomes:
Other outcomes:
Locations:
city: Bissau
country: Guinea-Bissau
facility: Bandim Health Project, Apartado 861
Study officials:
affiliation: Bandim Health Project
name: Peter Aaby, DMSc
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02412423: Post-transplantation Cyclophosphamide for Haploidentical Transplant From Maternal or Collateral Donors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hematopoietic Stem Cell Transplantation
Lead sponsor: Peking University People's Hospital
Sponsor class: OTHER
First posted: 2015-04-09
Enrollment: 30
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: In "beijing model" for haploidentical transplant, the rate of acute graft-versus-host disease (GVHD) from maternal or collateral donors was significantly higher than that from other kins. To reduce the GVHD incidence from maternal or collateral donors, post-transplantation cyclophosphamide is planned to be added into the protocol in "beijing model".


Eligibility criteria: Inclusion Criteria:

* haploidentical patients from maternal or collateral donors

Exclusion Criteria:

* uncontrolled infection before transplant

Primary outcomes:
measure: rate of acute GVHD
timeFrame: participants will be followed for an expected average of 365 days
Secondary outcomes:
measure: rate of non-relapse mortality
timeFrame: participants will be followed for an expected average of 365 days
measure: rate of relapse
timeFrame: participants will be followed for an expected average of 365 days
measure: probability of survival
timeFrame: participants will be followed for an expected average of 365 days
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University People's Hospital
Study officials:
References:
citation: Wang Y, Wu DP, Liu QF, Xu LP, Liu KY, Zhang XH, Yu WJ, Xu Y, Huang F, Huang XJ. Low-dose post-transplant cyclophosphamide and anti-thymocyte globulin as an effective strategy for GVHD prevention in haploidentical patients. J Hematol Oncol. 2019 Sep 3;12(1):88. doi: 10.1186/s13045-019-0781-y.
Clinical trial NCT03881423: Deep vs Moderate Neuromuscular Blockade in Day Case Laparoscopic Cholecystectomy.
Official title: Deep vs Moderate Neuromuscular Blockade on Surgical Conditions and Quality of Recovery in Day Case Laparoscopic Cholecystectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Muscle Relaxation
Lead sponsor: Ain Shams University
Sponsor class: OTHER
Collaborators: name: Elite medical center
First posted: 2019-03-19
Enrollment: 80
Sex: ALL
Minimum age (years): 21
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Laparoscopic cholecystectomy (LC) is commonly performed on ambulatory basis as a result of its ability to improve postoperative quality of recovery (QOR) and significantly reduce hospital stay .

Detailed description: Laparoscopic cholecystectomy (LC) is commonly performed on ambulatory basis as a result of its ability to improve postoperative quality of recovery (QOR) and significantly reduce hospital stay.

The surgeon requires a good surgical conditions to perform the operation, whereas the anesthesiologist is concerned with postoperative QOR. Pneumoperitoneium -associated expansion of the abdominal cavity during LC is related to postoperative pain.

and other physiological changes, affecting the postoperative QOR negatively . Poor postoperative QOR leads to prolonged hospital stay .

Eligibility criteria: Inclusion Criteria:

* ASA I and II

Exclusion Criteria:

* Neuromuscular disorders

Primary outcomes:
measure: Surgical conditions
timeFrame: Intraoperative
measure: Quality of recovery
timeFrame: 24 hours postoperative
Secondary outcomes:
measure: Postoperative pain
timeFrame: During the length of hospital stay post surgery (on average 24 hours)
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ainshams University Hospitals
Study officials:
References:
Clinical trial NCT06685523: Evaluation of Fractalkine and Its Receptor in Peri-implantitis
Official title: Evaluation of Fractalkine and Its Receptor in the Non-Surgical Treatment of Peri-implantitis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Peri-implantitis
Keywords: Er:YAG laser
Debridment
peri-implantitis
Lead sponsor: Kırıkkale University
Sponsor class: OTHER
First posted: 2024-11-12
Enrollment: 100
Sex: ALL
Minimum age (years): 40
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Four group:

* Peri-implant healty
* Mechanical curette
* Er:YAG laser
* Diyot laser
Primary purpose: TREATMENT

Brief summary: In this study, mechanical debridement group, Er:YAG laser group and diode laser group will be compared in terms of reducing peri-implant sulcus depth in the treatment of peri-implantitis.


Eligibility criteria: Inclusion Criteria:

* Probing depth of 4-6 mm, bone loss of at least 2 mm on X-ray and presence of inflammatory symptoms in soft tissue
* No systemic disease that may affect the outcome of the treatment
* Patients with healthy periodontium or patients with completed periodontal treatment
* Individuals at least 6 months after prosthesis loading on the implant
* Individuals who do not require further surgery for the treatment of peri-implantitis
* Implants with at least 2 mm keratised gingiva
* Individuals aged 40-60 years

Exclusion Criteria:

* Individuals undergoing radiation therapy
* Individuals who smoke and drink alcohol
* Individuals in pregnancy or lactation
* Individuals who have received antibiotic treatment in the last three months
* Individuals with parafunctional habits

Primary outcomes:
measure: Probing depth, clinical attachment loss
timeFrame: sixth month
Secondary outcomes:
measure: gingival index, plaque index, sulcus blood index
timeFrame: sixth month
Other outcomes:
Locations:
city: Kırıkkale
country: Turkey
facility: Kırıkkale University, Faculty of Dentistry, Department of Periodontology
Study officials:
References:
Clinical trial NCT01992523: Mojito Study (Mashed Or Just Integral Pill of TicagrelOr ? )
Official title: Mojito Study (Mashed Or Just Integral Pill of TicagrelOr ? )
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Acute Coronary Syndrome
Adverse Reaction to Antiplatelet Agent
Keywords: Ticagrelor
antiplatelet
Acute Coronary Syndrome
Lead sponsor: Careggi Hospital
Sponsor class: OTHER
Collaborators: name: AstraZeneca
name: A.R. CARD Onlus Foundation
First posted: 2013-11-25
Enrollment: 82
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of the Mashed Or Just Integral pill of TicagrelOr (MOJITO) study is to evaluate the superiority of Ticagrelor 180 mg LD mashed pill versus Ticagrelor 180 mg LD integral pill both orally administrated in decreasing residual platelet reactivity 1 hour after the administration among 70 patients with STEMI (ST segment elevation myocardial infarction) undergoing PPCI (primary percutaneous coronary intervention) with bivalirudin monotherapy.


Eligibility criteria: Inclusion Criteria:

* Patients presenting within 12 hours from the onset of symptoms with STEMI
* Informed, written consent

Exclusion Criteria:

* Age \< 18 years or Age \> 75 years
* Active bleeding; bleeding diathesis; coagulopathy
* Increased risk of bradycardiac events
* History of gastrointestinal or genitourinary bleeding \<2 months
* Major surgery in the last 6 weeks
* History of intracranial bleeding or structural abnormalities
* Suspected aortic dissection
* Any other condition that may put the patient at risk or influence study results or investigator's opinion (severe hemodynamic instability, known malignancies or other comorbid conditions with life expectancy \<1 year)
* Administration in the week before the index event of clopidogrel, ticlopidine, prasugrel, ticagrelor, thrombolytics, bivalirudin, low-molecular weight heparin or fondaparinux .
* Concomitant oral or IV therapy with strong CYP3A inhibitors or strong CYP3A inducers, CYP3A with narrow therapeutic windows
* Known relevant hematological deviations: Hb \<10 g/dl, Thrombi. \<100x10\^9/l
* Use of coumadin derivatives within the last 7 days
* Chronic therapy with ticagrelor, prasugrel, clopidogrel or ticlopidine
* Known severe liver disease, severe renal failure
* Known allergy to the study medications
* Pregnancy

Primary outcomes:
measure: Residual Platelet Reactivity
timeFrame: 1 hour
Secondary outcomes:
measure: High Residual Platelet Reactivity
timeFrame: 1 hour
measure: Bleeding Events
timeFrame: 48 hours
measure: Dyspnoea and/or Symptomatic Bradycardia
timeFrame: 6 months
Other outcomes:
Locations:
city: Patras
country: Greece
facility: Department of Cardiology, Patras University Hospital
city: Florence
country: Italy
facility: Careggi Hospital
Study officials:
affiliation: Careggi Hospital, Division of Invasive Cardiology
name: Guido Parodi, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Careggi Hospital, Division of Invasive Cardiology
name: David Antoniucci, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT05181423: Identification of Noninvasive Biomarkers for Neonates Undergoing Abdominal Surgery
Official title: Identification of Noninvasive Biomarkers for Neonates Undergoing Abdominal Surgery
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Biomarkers
Neonate
Lead sponsor: West China Hospital
Sponsor class: OTHER
First posted: 2022-01-06
Enrollment: 2000
Sex: ALL
Minimum age (years): 0
Maximum age (years): 18
Standard ages: CHILD
ADULT
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Neonates undergoing abdominal surgery.

Brief summary: To identify the potential serum and radiological biomarkers with regard to neonates undergoing abdominal surgery, and to further evaluate the prognostic value of these markers.

Detailed description: First, the investigators will collect serum biomarkers in neonate patients receiving abdominal surgery. Then the investigators will identify the characteristics and change of biomarkers expressed in neonate patients before and after abdominal surgery. The investigators will further evaluate the prognostic value of these markers for neonate patients receiving abdominal surgery.

Eligibility criteria: Inclusion Criteria:

* Age up to 18 years old
* With written informed consent

Exclusion Criteria:

* Clinical data missing
* Without written informed consent

Primary outcomes:
measure: Value of non-invasive biomarkers
timeFrame: At least 5-year follow up
Secondary outcomes:
Other outcomes:
Locations:
city: Chengdu
country: China
facility: West China Hospital, Sichuan University
state: Sichuan
Study officials:
References:
Clinical trial NCT04549623: End-Tidal Carbon Dioxide Monitoring Device for Sedation During Endoscopic Ultrasonography
Official title: The Effect of A Novel End-Tidal Carbon Dioxide Monitoring Device for Sedation During Endoscopic Ultrasonography-Guided Fine Needle Aspiration
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Endoscopic Ultrasonography
Sedation
Monitoring
Lead sponsor: Changhai Hospital
Sponsor class: OTHER
First posted: 2020-09-16
Enrollment: 480
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: To meet the needs of both operators and patients, moderate and deep sedation has been widely used in digestive endoscopy, which is invasive and painful. With its pleasant effects, sedation has complications nevertheless. And respiratory depression is the most common one, which makes respiratory monitoring significant. SpO2 and respiratory motion are regularly monitored without satisfying timeliness or sensitivity. Capnography with current device is only able to detect either oral or nasal breathing. The present study was designed to test the effect of the investigator's modified End-Tidal Carbon Dioxide (ETCO2) monitoring device for sedation during endoscopic ultrasonography-guided fine needle aspiration.


Eligibility criteria: Inclusion Criteria:

* Scheduled for ultrasonography-guided fine needle aspiration
* Adult patients aged 18 to 65 years
* American Society of Anesthesiologists (ASA) Physical Status Classification I-III
* Subjects provide informed consent

Exclusion Criteria:

* Full stomach or upper gastrointestinal tract obstruction
* Baseline pulse oximetric saturation (SpO2) \<95% while breathing room air
* Obesity （BMI≥28kg/m2）or anticipated difficult airway
* Cardiovascular or cerebrovascular events within 3 months
* Pregnancy
* Chronic opioid user
* Allergic to anesthetics

Primary outcomes:
measure: Peripheral oxygen saturation
timeFrame: Across the sedation, assessed up to 2 hours
Secondary outcomes:
measure: Arterial pO2 and pCO2
timeFrame: 30 minutes after initiation of the sedation
measure: The numbers of the times of body movement
timeFrame: From the completion of sedation to the completion of endosonography procedure, assessed up to 2 hours
measure: Incidence of hypertension and hypotension
timeFrame: From the completion of sedation to the completion of endosonography procedure, assessed up to 2 hours
measure: Recovery time
timeFrame: After termination of the sedation medication, assessed up to 2 hours
measure: Total dosage of propofol
timeFrame: Across the sedation, assessed up to 2 hours
measure: Satisfaction score of the patients and endosonographers
timeFrame: Across the procedure, assessed up to 2 hours
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Faculty of Anesthesiology, Changhai Hospital
state: Shanghai
Study officials:
References:
Clinical trial NCT01276223: Evaluation of Anti-Inflammatory Treatment in Dry Eye Patients
Official title: A Multi-Center, Randomized, Double-Masked Evaluation of Anti-Inflammatory Treatment in Patients With Dry Eye
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Dry Eye Disease
Keywords: Dry eye
ocular discomfort
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2011-01-13
Enrollment: 722
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study was to determine if difluprednate ophthalmic emulsion is effective in reducing the ocular symptoms of dry eye disease, as measured by a global Visual Analog Scale (VAS) discomfort score.

Detailed description: Following Run-In, patients qualifying for treatment were randomized 1:1 to receive Durezol (experimental group) or Vehicle (control group) for 5 weeks.

Eligibility criteria: Inclusion Criteria:

Normal subjects:

* No known history of dry eye disease.
* Non-contact lens wearer.
* No current use of artificial tears or any other dry eye treatment.

OR

Dry eye patients:

* At least a 6 month history of dry eye.
* Non-contact lens wearer.
* Uses artificial tears.
* Experiences persistent ocular discomfort.
* Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

* The presence of any acute infectious or non-infectious ocular conditions in either eye within 1 month of Visit 1.
* Severe Sjogren's Syndrome.
* Lid function abnormalities.
* Use of steroids, tetracycline, doxycycline, etc., within 30 days of Visit 1.
* History of corneal surgery including refractive surgeries.
* History of glaucoma or ocular hypertension
* Other protocol-defined exclusion criteria may apply.

Primary outcomes:
measure: Mean Change From Baseline (Week 0) in Visual Analog Scale (VAS) Global Ocular Discomfort Score Over 4 Weeks
timeFrame: Baseline, up to 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Fort Worth
country: United States
facility: Contact Alcon Call Center at 1-888-451-3937 for Trial Locations
state: Texas
Study officials:
References:
Clinical trial NCT05484323: Acute Effects of Cookies Containing 2.5 g Spirulina on Postprandial Glycemic and Insulin Responses
Official title: Acute Effects of Cookies Containing 2.5 g Spirulina on Postprandial Glycemic and Insulin Responses: A Randomized Clinical Trial in Healthy Humans
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Potential Abnormality of Glucose Tolerance
Appetitive Behavior
Blood Pressure
Keywords: blood glucose responses
spirulina
blood glucose concentrations
glycemic index
Lead sponsor: Agricultural University of Athens
Sponsor class: OTHER
First posted: 2022-08-02
Enrollment: 13
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Crossover, double blind, randomized clinical trial
Primary purpose: OTHER

Brief summary: This study investigated the effects of cookies containing 2.5 g Spirulina on postprandial glycemic and insulin responses.

Detailed description: This study examined the short-term effects of cookies containing 0 and 2.5 g Spirulina on postprandial glycemic and insulin responses, arterial blood pressure and subjective appetite

Eligibility criteria: Inclusion Criteria:

* healthy
* non-smoking
* men and women
* body mass index between 18 and 24.9 kg/m2

Exclusion Criteria:

* severe chronic disease (e.g. cardiovascular diseases, diabetes mellitus, kidney or liver conditions, endrocrine conditions)
* gastrointestinal diseases
* pregnancy
* lactation
* competitive sports
* alcohol abuse
* drug dependency

Primary outcomes:
measure: Capillary blood glucose responses
timeFrame: 2 hours
Secondary outcomes:
measure: Salivary insulin responses
timeFrame: 2 hours
Other outcomes:
measure: Subjective appetite ratings
timeFrame: 2 hours
measure: Blood pressure
timeFrame: 2 hours
Locations:
city: Athens
country: Greece
facility: Agricultural University of Athens
Study officials:
affiliation: Agricultural University of Athens
name: Emilia Papakonstantinou, PhD
role: PRINCIPAL_INVESTIGATOR
References: