louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02139228: Persistency Study After Hib-CRM (Cross-Reacting Material)197 or Hib-TT (Tetanus Toxoid) Vaccines in Chinese Children
Official title: A Phase IIIb, Controlled, Open Label, Single-Center, Persistency, Extension Study in Chinese Children After a 2+1 Dose Series of Either CRM197-Conjugate Haemophilus Influenzae Type b Vaccine or Tetanus Toxoid-Conjugate Haemophilus Influenzae Type b Vaccine
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Meningitis, Epiglottitis, Pneumonia, Arthritis Caused by Haemophilus Influenzae Type b
Keywords: Haemophilus influenzae type b
persistency
children
CRM197
anti-PRP antibody
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2014-05-15
Enrollment: 426
Sex: ALL
Minimum age (years): 5
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Evaluate the persistency of immune response against Haemophilus influenzae type b by assessing anti-PRP antibody levels in children vaccinated with either Hib-CRM197 or Hib-TT booster vaccine approximately 4 years before.


Eligibility criteria: Inclusion Criteria:

1. Children previously enrolled in V37_07E1 study and who received the appropriate vaccination.
2. Children whose parent(s) or legal guardian(s) had given written consent after the nature of the study was explained according to local regulatory requirements.

Exclusion Criteria:

1. Any confirmed or suspected current immunosuppressive or immunodeficient condition since the end of V37_07E1 study, based on medical history and physical examination (no laboratory testing required).
2. Treatment with corticosteroids or other immunosuppressive/immunostimulant drugs as defined below:

   i) chronic use of oral and parenteral immunosuppressants (\>= 15 days of use) or other immune-modifying drugs within 60 days prior to the blood sampling (short term usage of topical, inhaled and/or intranasal corticosteroids were allowed) ii) receipt of immunostimulants within 60 days prior to Visit 1
3. Administration of immunoglobulins and/or any blood products up to 3 months before enrollment.
4. Use of any investigational or non-registered product (drug or vaccine) within 30 days preceding the blood sampling.
5. Any condition, which, in the opinion of the investigator, might be a contraindication to the execution of the blood draw.

Primary outcomes:
measure: Geometric Mean Anti-PRP (Polyribosyl Ribitol Phosphate) Concentrations at Day 1 (4 Years Post Booster Dose Administered in Study V37_07E1)
timeFrame: At Day 1 (4 years post booster dose administered in study V37_07E1)
Secondary outcomes:
measure: Percentages of Subjects With Anti-PRP Concentrations ≥1.0 μg/mL and ≥0.15 μg/mL at Day 1 (4 Years Post Booster Dose Administered in Study V37_07E1)
timeFrame: At Day 1 (4 years post booster dose administered in study V37_07E1)
Other outcomes:
Locations:
city: Dingxing
country: China
facility: DingXing Center for Disease Control and Prevention
state: Hebei
Study officials:
affiliation: Novartis Vaccines
name: Novartis Vaccines
role: STUDY_CHAIR
References:
Clinical trial NCT03297528: Chemotherapy and DLI for Prevention of Second Relapse in Patients With Relapsed Acute Leukemia After Allotransplant
Official title: Multiple Consolidation Chemotherapy and DLI Prevent Second Relapse in Patients With Relapsed Acute Leukemia After Allotransplant and Achieving Complete Remission After Induction Chemotherapy and DLI
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Donor Lymphocyte Infusion
Allogeneic Hematopoietic Stem Cell Transplantation
Acute Leukemia
Minimal Residual Disease
Graft-versus-host Disease
Relapse
Lead sponsor: Peking University People's Hospital
Sponsor class: OTHER
First posted: 2017-09-29
Enrollment: 40
Sex: ALL
Minimum age (years): 5
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Patients with acute leukemia relapsing after allotransplant and who respond to anti-leukaemia interventions are at high-risk of a second relapse. Previous studies from investigators reported an association between a positive minimal residual disease (MRD)-test after transplant and an increased risk of subsequent relapse. Also, patients developing chronic graft-versus-host disease (GvHD) after receiving DLI (donor lymphocyte infusion)for leukemia relapse after a first allotransplant have a lower likelihood of a second relapse compared with similar patients not developing chronic GvHD. And, our previous study also reported patients with chronic GvHD after DLI was associated with a greater frequency of a negative MRD-test and lower likelihood of subsequent relapse compared with similar persons not developing chronic GvHD. Based on these data the investigators designed a randomized control study to determine whether giving additional consolidation chemotherapy and DLI might decrease likelihood of second relapse in persons without chronic GvHD or with a positive MRD-test after initial post-relapse therapy with induction chemotherapy and DLI.


Eligibility criteria: Inclusion Criteria:

* (1) acute leukemia in first complete or second complete remission;
* (2) relapse after an allotransplant;
* (3) had full or partial donor chimerism;
* (4) received re-induction chemotherapy and DLI and achieved a negative MRD-test.

Exclusion Criteria:

* (1) active GvHD
* (2) active infection
* (3) organ dysfunction

Primary outcomes:
measure: Number of participants with a positive results of minimal residual disease that is evaluated by testing aberrant leukemia-associated immune phenotypes and WT1 mRNA levels.
timeFrame: one year
Secondary outcomes:
measure: Number of participants who relapsed
timeFrame: one year
measure: Number of surviving participants
timeFrame: one year
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University Institute of Hematology,Beijing
state: Beijing
Study officials:
affiliation: Peking University People's Hospital
name: Xiao-jun Huang
role: STUDY_DIRECTOR
References:
Clinical trial NCT03557528: Role of Low Inferior Mesenteric Artery Ligation During Laparoscopic Surgery for Rectosigmoid Cancer
Official title: Evaluation of the Role of Low Inferior Mesenteric Artery Ligation During Laparoscopic Surgery for Rectosigmoid Tumors
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rectosigmoid Adenocarcinoma
Lead sponsor: University of Roma La Sapienza
Sponsor class: OTHER
First posted: 2018-06-15
Enrollment: 120
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients affectced by clinical stage I-III cancer of sigmoid and rectum.

Brief summary: During sigmoid or rectal cancer surgery, dissection of lymphnodes at the origin of inferior mesenteric artery is mandatory. Nevertheless, ligation of the origin of IMA should compromise blood supply to left colon and affect anastomosis. The aim of this retrospective evaluation is to compare high and low IMA ligation with preservation of LCA, with or without skeletonization of the origin of IMA in laparoscopic colorectal resection.


Eligibility criteria: Inclusion Criteria:

* stage I-III carcinoma

Exclusion Criteria:

* stage IV
* Urgent resection
* conversion to open surgery

Primary outcomes:
measure: effectivenes of lymphnode dissection
timeFrame: 3 years
Secondary outcomes:
measure: complication
timeFrame: 3 years
Other outcomes:
Locations:
city: Roma
country: Italy
facility: Policlinico Umberto I
Study officials:
References:
Clinical trial NCT02747628: Transdermal Nicotine and Melatonin Patches for Postoperative Pain Relief
Official title: Comparative Study Between Transdermal Nicotine and Melatonin Patches on Postoperative Pain Relief After Laparoscopic Cholecystectomy, a Double-blind, Placebo-controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Postoperative Pain Relief
Keywords: Transdermal nicotine
Transdermal melatonin
Postoperative pain
Laparoscopic cholecystectomy
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2016-04-22
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Sixty female non-smoker patients, aged 18-50 years and ASA I and II undergoing elective laparoscopic cholecystectomy under general anesthesia were included in this randomized controlled double-blind study. Patients were randomly divided into 3 groups 20 each, C group patients received transdermal placebo patch, TDN group (15 mg/16 h) and TDM group (7 mg/8h). Assessment of postoperative pain, sedation, hemodynamic variables such as HR and MAP, postoperative monitoring of arterial SpO2 and side effects (e.g. nausea, vomiting, pruritis, respiratory depression and hemodynamic instability) were done 30 minutes, 1, 2, 6 and 12 hours postoperatively. Postoperative Patient's and Surgeons' satisfaction, Intraoperative bleeding and plasma cortisol (µg / dl) 2 hours postoperatively were also assessed.


Eligibility criteria: Inclusion Criteria:

* 60 female patients.
* non-smoker patients.
* aged between 18 and 50 years old.
* ASA physical status I and II.
* 70-90 kg body weight and height 160-180 cm.
* undergoing elective laparoscopic cholecystectomy under general anesthesia.

Exclusion Criteria:

* Patients with impaired kidney or liver functions.
* history of cardiac or central nervous system disease.
* history of smoking.
* history of drug or alcohol abuse.
* history of chronic pain or daily intake of analgesics.
* uncontrolled medical disease (diabetes mellitus and hypertension).
* history of intake of non-steroidal anti-inflammatory drugs or opioids within 24 h before surgery.
* allergy to the used medications.
* coagulation defect.
* local infection at the site of application of transdermal patch.
* patient's refusal.
* duration of surgery more than 120 minutes.

Primary outcomes:
measure: A Mean Difference of Total Analgesic (Pethidine) Consumption.
timeFrame: [Time Frame: The total pethidine requirements (mg) 12 hours postop]
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06435728: Predictive Value of Combining AccuIMR and AccuFFR in Patients With STEMI
Official title: Predictive Value of Combining Angio-Based Index of Microcirculatory Resistance and Fractional Flow Reserve in Patients With STEMI
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Acute ST Segment Elevation Myocardial Infarction
Prognosis
Lead sponsor: Peking University Third Hospital
Sponsor class: OTHER
First posted: 2024-05-30
Enrollment: 1297
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with STEMI who underwent primary PCI and were hospitalized at Peking University Third Hospital between January 2017 and March 2022.

Brief summary: Patients with acute myocardial infarction were enrolled retrospectively. The fractional flow reserve (AccuFFR) and microcirculatory resistance index (AccuIMR) based on coronary angiography were analyzed, and the relationship between FFR and IMR and the prognosis of patients with acute myocardial infarction was analyzed

Detailed description: We retrospectively enrolled STEMI patients who underwent PCI in Peking University Third Hospital. The fractional flow reserve (AccuFFR) and microcirculatory resistance index (AccuIMR) based on coronary angiography were obtained by analyzing the coronary angiography images. The prognosis of patients was obtained by searching inpatient and outpatient systems and telephone follow-up. The relationship between AccuFFR, AccuIMR and prognosis was statistically analyzed

Eligibility criteria: Inclusion Criteria:

* Age of \>18 years;
* Onset-to-treatment time of ≤12 h, meeting the diagnostic criteria for STEMI;
* underwent primary PCI within 12 h of symptom onset and achieved successful PCI in the culprit vessel;
* Availability of complete clinical data

Exclusion Criteria:

* severe tortuosity and overlap of the target vessel;
* poor-quality coronary angiography images;
* missing two coronary angiography images \>25° apart

Primary outcomes:
measure: MACE
timeFrame: 3 years after myocardial infarction
Secondary outcomes:
measure: recurrent coronary events
timeFrame: 3 years after myocardial infarction
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University Third Hospital
Study officials:
affiliation: Peking University Third Hospital
name: Ming Cui, Dorctor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06998628: Pentoxifylline as Anti-Inflammatory in Patients With Rheumatoid Arthritis
Official title: Clinical Study Evaluating the Effect of Pentoxifylline as Anti Inflammatory in Patients With Rheumatoid Arthritis
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: Rheumatoid Arthritis
Lead sponsor: Tanta University
Sponsor class: OTHER
Collaborators: name: Prof. Sahar Kamal Hegazy, Professor of Clinical Pharmacy, Faculty of Pharmacy - Tanta University
name: Dr. Mustafa Adel Mustafa Elmenawy Lecturer of Rheumatology and Rehabilitation, Faculty of Medicine - El-Azhar University - Damietta
First posted: 2025-05-31
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Rheumatoid arthritis (RA) is a long-term inflammatory condition that leads to gradual damage of joints lined by synovial membranes, along with various potential effects outside of the joints. While RA can affect any joint, it typically involves the metacarpophalangeal, proximal interphalangeal, and metatarsophalangeal joints, as well as the wrists and knees. Symptoms related to the joints and surrounding tissues include swelling, tenderness upon touch, morning stiffness, and significant difficulty moving the affected joints


Eligibility criteria: Inclusion Criteria:

* Patients with active rheumatoid arthritis (not in remission) according to American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) \[9\] i.e., 28 joints disease activity score (DAS 28) \>2.6.
* Patients receiving the conventional DMARDs.
* Both sexes.
* Age range between 18and 70 years old

Exclusion Criteria:

* Patients with retinal or cerebral hemorrhage.
* Patients with renal and hepatic dysfunction.
* Patients with hypersensitivity to study medications.
* Pregnant and lactating females.
* Patients receiving biological or synthetic DMARDs

Primary outcomes:
measure: change in Disease Activity Score (DAS28)
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Damietta
country: Egypt
facility: Faculty of Medicine, Al-Azhar University
Study officials:
References:
Clinical trial NCT04497428: Sensory Basis of Speech Motor Learning
Official title: Brain Structures in Speech Motor Memory Consolidation
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Speech
Consolidation
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: McGill University
name: National Institute on Deafness and Other Communication Disorders (NIDCD)
First posted: 2020-08-04
Enrollment: 160
Sex: ALL
Minimum age (years): 21
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: These studies test the hypothesis that sensory areas of the brain participate in the consolidation of speech motor memory by using transcranial magnetic stimulation to suppress activity in somatosensory and auditory cortex following adaptation in order to block retention of learning.

Detailed description: Subjects will train using either altered somatosensory feedback or altered auditory feedback (different groups of subjects). Immediately following adaptation, continuous theta burst magnetic stimulation (cTBS) will be applied to either auditory or somatosensory or motor cortex with the goal of blocking consolidation of motor memory. The logic of applying cTBS to both sensory areas is to test the hypothesis that both areas are involved in motor memory consolidation. Subjects leave the laboratory following cTBS and return 24 hours later to assess retention of learning. Learning is assessed as percentage change in speech sounds or movements relative to baseline. Retention is measured on a 0 to 100 scale relative to the end of learning.

Eligibility criteria: Inclusion Criteria:

* right handed adults
* no known physical or neurological abnormalities

Exclusion Criteria:

* patients with:
* cardiac pacemaker
* surgical clips or values on the heart
* implants
* metal or metallic fragments in any part of the body
* pregnancy
* claustrophobia
* a personal or family history of epilepsy
* currently taking antipsychotic drugs
* currently taking antidepressant drugs
* currently taking antianxiety drugs
* history of concussion.

Primary outcomes:
measure: Motor Learning
timeFrame: Performance as measured at the end of learning (30 minute session)
measure: Retention of Learning
timeFrame: 24 hours after learning (re-test lasts 30 minutes)
Secondary outcomes:
Other outcomes:
Locations:
city: Montréal
country: Canada
facility: McGill University
state: Quebec
Study officials:
affiliation: Haskins Laboratories
name: David Ostry
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04060628: Expanded Access to NanoDoce
Official title: Expanded Access to NanoDoce
Study type: EXPANDED_ACCESS
Overall status: AVAILABLE
Conditions: Urogenital Neoplasms
Lead sponsor: NanOlogy, LLC
Sponsor class: INDUSTRY
Collaborators: name: US Biotest, Inc.
First posted: 2019-08-19
Standard ages: CHILD
ADULT
OLDER_ADULT

Brief summary: NanOlogy may consider offering expanded access to NanoDoce for patients who do not meet the enrollment criteria of clinical trials in progress.


Eligibility criteria: Inclusion Criteria:

-

Exclusion Criteria:

-

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04117828: Assessment of Glycemic Index of Different Dates
Official title: Assessment of Glycemic Index of Different Dates
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Glycemic Index and Glycemic Load
Lead sponsor: Aga Khan University
Sponsor class: OTHER
First posted: 2019-10-07
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 40 participants will be included in the study and will be divided into four groups. The AKU faculty and staff will be invited to MDL with fasting of 12 hr. Written informed consent (a copy will also be provided to the participant) will be taken from each individual.Following vitals will be measured body weight, height and blood pressure. 1st group will be the control that will consume 50 g of glucose and 2nd, 3rd, and 4th group will consume 50 g of different kinds of dates. Their blood sugar level will be checked at 0, 30, 60, 90 and 120 mins. Glycemic index and glycemic load will be calculated and will be compared.
Primary purpose: OTHER

Brief summary: Glycemic Index is a system of classification of different foods with significant levels of carbohydrates based on how they affect blood glucose levels after being consumed. In this study we will compare glycemic index of different varieties

Detailed description: Glycemic Index is a system of classification of different foods with significant levels of carbohydrates based on how they affect blood glucose levels after being consumed. Despite being a significant parameter of blood glucose, GI does not depict the effect of the food when taken in a controlled recommended amount, and so the Glycemic Loads (GL) must also be calculated, thereby measuring the impact on glycemic levels after consumption of standard food portion sizes. Dates are high energy foods consumed in various parts of the world, are known to be a source of several important nutrients and are also shown to have significant impacts in preventing illnesses due to their anti-inflammatory and anti-microbial actions as well as preventative action against oxidative reactions The greatly frequent consumption of dates necessitates the identification of their GI and GL to ensure whether consumption is beneficial and safe for individuals. The objective of the study is to determine and compare the values of GI and GL of three varieties of dates in order to assess their safe consumption by individuals

Eligibility criteria: Inclusion Criteria:

* General population from AKU
* Adult ages (18- 60 years) will be included in the study

Exclusion Criteria:

* Individuals with Dates/Ajwa allergy
* Pregnant women and individuals with diabetes, metabolic syndrome or any other co-morbidity will be excluded

Primary outcomes:
measure: Blood Glucose level
timeFrame: 1 week
Secondary outcomes:
Other outcomes:
Locations:
city: Karachi
country: Pakistan
facility: Agha Khan University Hospital
state: Sindh
Study officials:
affiliation: AKU
name: Naseer Ahmed, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04533828: 68Ga-FAPI PET/CT in Liver Fibrosis Patients
Official title: Value of 68Ga-FAPI-04 PET/CT for Diagnosis and Prognostic Evaluation in Liver Fibrosis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: EARLY_PHASE1
Conditions: Liver Fibrosis
Positron Emission Tomography
Lead sponsor: First Affiliated Hospital of Fujian Medical University
Sponsor class: OTHER
First posted: 2020-09-01
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: To evaluate the potential value of 68Ga-FAPI-04 positron emission tomography/computed tomography (PET/CT) for the diagnosis and prognosis in liver fibrosis disease.

Detailed description: Subjects with liver fibrosis underwent 68Ga-FAPI-04 PET/CT scanning. Liver fibrosis lesion uptake was quantified by the maximum standard uptake value (SUVmax). Subjects also received the conventional clinical assessment for liver fibrosis, such as transient elastography (TE) and blood biochemical indexes (BBI) testing. The sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV) and accuracy of 68Ga-FAPI-04 PET/CT, TE and BBI were calculated and compared to evaluate the diagnostic efficacy.

Eligibility criteria: Inclusion Criteria:

* adult patients (aged 18 years or order)
* patients with suspected or new diagnosed or previously treated liver fibrosis (supporting evidence may include TE, BBI, MRI, CT and pathology report)
* patients who had scheduled 68Ga-FAPI-04 PET/CT scan
* patients who were able to provide informed consent (signed by participant, parent or legal representative) and assent according to the guidelines of the Clinical Research Ethics Committee

Exclusion Criteria:

* patients without liver fibrosis lesions
* patients with pregnancy
* the inability or unwillingness of the research participant, parent or legal representative to provide written informed consent

Primary outcomes:
measure: Standardized uptake value (SUV)
timeFrame: 30 days
Secondary outcomes:
measure: Liver stiffness measurement (LSM)
timeFrame: 30 days
measure: Blood biochemical indexes (BBI) testing
timeFrame: 30 days
Other outcomes:
Locations:
city: Fuzhou
country: China
facility: The First Affiliated Hospital of Fujian Medical University
state: Fujian
Study officials:
References: