louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02267486: Exploratory Study for the Validity of QuQu Scale
Official title: Exploratory Study for the Validity of a Novel Dementia Rating Scale (QUick QUestion Scale) for Alzheimer's Disease Dementia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Alzheimer Dementia
Keywords: Alzheimer Dementia, AD
patients
cognitive
Lead sponsor: Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan
Sponsor class: OTHER
Collaborators: name: Daiichi Sankyo Co., Ltd.
First posted: 2014-10-17
Enrollment: 972
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Alzheimer Dementia (AD), non-dementia

Brief summary: Examine the construct validity, the group discriminant ability, and the inter-rater reliability of a novel dementia rating scale (QuQu scale: QUick QUestion scale) candidate for the evaluation of patients with Alzheimer Dementia (AD)


Eligibility criteria: Inclusion Criteria:

1. Alzheimer Dementia (AD) patients and patients with cognitive concern without dementia
2. Written Informed consent by each subject and/or a legal representative, and study informant. If the doctor decides that the patient has no trouble in understanding this study, the written informed consent of a legal representative may be exempted. If not, this study needs a written informed consent by a legal representative and the patient except the case where the consent is hardly obtained due to the progression of the disease.

Exclusion Criteria:

1. patients with other types of dementia (e.g. vascular dementia, Levy body dementia, frontotemporal dementia)
2. patients with other diseases which cause secondary dementia prior to Alzheimer Dementia (AD)
3. patients with other severe neurological disease or psychiatric disorder without Alzheimer Dementia (AD)
4. patients with other medical conditions where the investigators determine that it is inappropriate for the subject of this study (e.g. inappropriate for the evaluation of dementia rating scale)

Primary outcomes:
measure: Novel Dementia Rating Scale (QUick QUestion Scale)
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Kida-gun
country: Japan
facility: Kagawa University School of Medicine
state: Kagawa
Study officials:
affiliation: Kagawa University School of Medicine
name: Yu Nakamura
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02535286: Study of Immunotherapy in Combination With Ublituximab and Umbralisib in Patients With Relapsed-refractory CLL or Richter's Transformation
Official title: Phase I Study of Ublituximab and Umbralisib in Combination With Targeted Immunotherapy in Patients With Relapsed-refractory Chronic Lymphocytic Leukemia (CLL) or Richter's Transformation (RT) of CLL
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Chronic Lymphocytic Leukemia
Richter Syndrome
Lead sponsor: TG Therapeutics, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Memorial Sloan Kettering Cancer Center
First posted: 2015-08-28
Enrollment: 27
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: The purpose of this study is to evaluate the safety and effectiveness of targeted immunotherapy in combination with ublituximab and umbralisib, in patients with advanced CLL or Richter's Transformation.


Eligibility criteria: Inclusion Criteria:

* Confirmed diagnosis of B-cell Chronic Lymphocytic Leukemia or Richter's Transformation
* Refractory to or relapsed after at least 1 prior treatment regimen
* Eastern Cooperative Oncology Group (ECOG) score of 0 to 2

Exclusion Criteria:

* Any major surgery, chemotherapy or immunotherapy within the last 14 days
* Known hepatitis B virus, hepatitis C virus or HIV infection
* Active autoimmune disorder (with the exception of autoimmune hemolytic anemia or ITP)

Primary outcomes:
measure: Determine Acceptable Adverse Events That Are Related to Treatment
timeFrame: 6 months of therapy
Secondary outcomes:
measure: Overall Response Rate
timeFrame: Up to 1 year
Other outcomes:
Locations:
city: New York
country: United States
facility: TG Therapeutics Investigational Trial Site
state: New York
city: Durham
country: United States
facility: TG Therapeutics Investigational Trial Site
state: North Carolina
city: Philadelphia
country: United States
facility: TG Therapeutics Investigational Trial Site
state: Pennsylvania
city: Seattle
country: United States
facility: TG Therapeutics Investigational Trial Site
state: Washington
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Anthony R. Mato, MD
role: STUDY_CHAIR
References:
Clinical trial NCT05009186: Changing of Prostate Specific Antigen Value in Patients With Covid-19
Official title: Changing of PSA With Covid-19
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Covid19
Prostate Specific Antigen
Keywords: Covid-19
Prostate cancer
Prostate Specific Antigen
Lead sponsor: Saglik Bilimleri Universitesi
Sponsor class: OTHER
First posted: 2021-08-17
Enrollment: 100
Sex: MALE
Minimum age (years): 45
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: We measured PSA value during and after Covid-19 infection
Primary purpose: DIAGNOSTIC

Brief summary: Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) caused a worldwide pandemic in over 100 years. The disease caused by this newly discovered virus was called Covid-19. In this study, we aimed to evaluate changing of PSA value in patients with Covid-19.

Detailed description: Patients with positive PCR test results were included in the study. The age of the patient and urea, leukocyte, hemoglobin, platelet, urea, and creatinine values of the patients were recorded. Urinalysis and urine culture were taken from all patients. Acute phase reactants such as sedimentation, C-reaktif protein (CRP), ferritin, and fibrinogen were measured both at the time the patients applied and three weeks after the patient recovered. PSA and free PSA were also measured in the same way. Patients whose symptoms improved and the PCR test result was negative were considered as recovered.

Eligibility criteria: Inclusion Criteria:

* Male patients (\>45 and \<70 years of age) positive PCR test results were included in the study

Exclusion Criteria:

* The patients \<45 and \>70 years of age who described lower urinary tract symptoms who had urinary tract infection who a history of prostate biopsy and previous high level of PSA who history of prostatitis were excluded.

Primary outcomes:
measure: PSA value
timeFrame: 2 months
Secondary outcomes:
measure: Ferritin, CRP
timeFrame: 2 months
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Omer Gokhan Doluoglu
state: Altindag
Study officials:
affiliation: Ankara Training and Research Hospital
name: Omer G Doluoglu, Associate Professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04786886: Patient Performance and Acceptance of Virtual Reality Visual Field Devices
Official title: Patient Performance and Acceptance of Virtual Reality Visual Field Devices
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Visual Field Defect, Peripheral
Visual Field Defect, Nasal Step
Visual Field Defect, Paracentral Scotoma of Both Eyes
Keywords: Retinal Sensitivity
Lead sponsor: University of Miami
Sponsor class: OTHER
First posted: 2021-03-08
Enrollment: 58
Sex: ALL
Minimum age (years): 13
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this research is to study the effectiveness and patient experience when measuring visual fields using virtual reality goggles.


Eligibility criteria: Inclusion Criteria:

* Any patient \>13 years old at Bascom Palmer Eye Institute
* Patients who either have glaucoma, are glaucoma suspects, or have a strong family history of glaucoma

Exclusion Criteria:

* Adults unable to consent, pregnant women, prisoners
* Patients under the age of 13

Primary outcomes:
measure: Operational Effectiveness
timeFrame: Day 1
measure: Medical Effectiveness as Measured by Visual Field Indexes
timeFrame: Day 1
measure: Medical Effectiveness as Measured by Glaucoma Hemifield Test
timeFrame: Day 1
measure: Reliability Indices
timeFrame: Day 1
Secondary outcomes:
Other outcomes:
Locations:
city: Miami
country: United States
facility: Bascom Palmer Eye Institute
state: Florida
Study officials:
affiliation: University of Miami
name: Alana Grajewski, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06372886: Clinical Outcomes of Preservation Versus Resection of Portal/Superior Mesenteric Vein During Pancreaticoduodenectomy in Pancreatic Cancer Patients Who Respond to Neoadjuvant Treatment
Official title: Clinical Outcomes of Preservation Versus Resection of Portal/Superior Mesenteric Vein During Pancreaticoduodenectomy in Pancreatic Cancer Patients Who Respond to Neoadjuvant Treatment
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pancreatic Head Cancer Patients Who Underwent Surgery After Neoadjuvant Treatment
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2024-04-18
Enrollment: 264
Sex: ALL
Maximum age (years): 79
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This study retrospectively included 264 pancreatic head cancer patients who underwent surgery after neoadjuvant treatment between January 2012 and December 2022 at Seoul National University Hospital in Korea. Among 264 patients, we included 113 patients with resectable and borderline resectable pancreatic ductal adenocarcinoma with venous involvement who responded to NAT and underwent curative PD.

Brief summary: 1. There is a lack of evidence on the need to perform portal/superior mesenteric vein (PV/SMV) resection routinely in pancreatic ductal adenocarcinoma (PDAC) patients with venous involvement who responded to neoadjuvant treatment (NAT).
2. There is no significant differences in R0 rate, 5-year overall survival and recurrence-free survival between the PV/SMV preservation (PVP) group and PV/SMV resection (PVR) group.
3. PVP group showed significantly better 5-year PV/SMV stenosis free survival than the PVR group.
4. We propose that if dissection is possible and there is a high likelihood of achieving R0 resection after NAT, routine PVR may be unnecessary in PDAC patients with venous involvement.


Eligibility criteria: Inclusion Criteria:

* Pancreatic head cancer patients who underwent surgery after neoadjuvant treatment between January 2012 and December 2022 at Seoul National University Hospital

Exclusion Criteria:

* Metastatic unresectable and locally advanced pancreatic cancer
* Resectable pancreatic cancer without portal/superior mesenteric vein invasion
* Cancer aggravation after neoadjuvant treatment
* Portal/superior mesenteric vein encasing and narrowing after neoadjuvant treatment
* Patients who underwent palliative surgery
* Non-pancreatic ductal adenocarcinoma patients
* Patients who death within 30 days of surgery
* Loss of follow-up patients
* Patients who underwent resection for suspected main artery and adjacent organ invasion

Primary outcomes:
measure: 5-year overall survival
timeFrame: assessed up to 60months
measure: 5-year portal/superior mesenteric vein stenosis free survival
timeFrame: assessed up to 60months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02506686: Meropenem Penetration Across BBB in Patients With CNS Infection and Optimization of Meropenem Treatment
Official title: Evaluation of Meropenem Penetration Across Blood-Brain Barrier in Patients With Central Nervous System Infection After Neurosurgery and Optimization of Meropenem Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Central Nervous System Infections
Lead sponsor: Huashan Hospital
Sponsor class: OTHER
First posted: 2015-07-23
Enrollment: 82
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: A prospective, open-label study investigated the pharmacokinetic profile of meropenem in patients with post-neurosurgical central nervous system (CNS) infection, especially its BBB penetration into cerebrospinal fluid (CSF).

Detailed description: Meropenem is important for management of post-neurosurgical meningitis, but the data about its penetration across blood-brain barrier (BBB) are inadequate. This prospective, open-label study investigated the pharmacokinetic profile of meropenem in patients with post-neurosurgical central nervous system (CNS) infection, especially its BBB penetration into cerebrospinal fluid (CSF). A total of 82 patients with post-neurosurgical CNS infection were included to receive meropenem intravenously according to regimen of 2g q8h, 1g q8h or 1g q6h. After infusion of 4 doses, blood and CSF samples were collected simultaneously at predefined timepoints. High-performance liquid chromatography ultraviolet method was used to determine the concentration of meropenem.

Eligibility criteria: Inclusion Criteria:

* at least 18 years of age
* requiring continuous drainage of CSF or gram-negative bacteria were identified from CSF culture
* have temperature fever (T \> 37.5℃)
* have signs of meningeal irritation
* white blood cells in CSF \> 300 × 10\^6/L

Exclusion Criteria:

* hypersensitive to meropenem
* did not receive at least 3 days of meropenem treatment
* are receiving hemodialysis
* unstable vital signs
* have lumbar puncture contraindications and so inappropriate for sample collection
* severe hepatic or renal dysfunction
* status epilepticus
* potential neurodegenerative diseases
* pregnancy
* breast-feeding

Primary outcomes:
measure: Concentrations of meropenem in plasma and CSF in patients with CNS Infections
timeFrame: Up to 12 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Huashan Hospital
name: Jufang Wu, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lu C, Zhang Y, Chen M, Zhong P, Chen Y, Yu J, Wu X, Wu J, Zhang J. Population Pharmacokinetics and Dosing Regimen Optimization of Meropenem in Cerebrospinal Fluid and Plasma in Patients with Meningitis after Neurosurgery. Antimicrob Agents Chemother. 2016 Oct 21;60(11):6619-6625. doi: 10.1128/AAC.00997-16. Print 2016 Nov.
Clinical trial NCT06271486: Pregabalin in Treatment of Postdural Puncture Headache
Official title: Pregabalin as Alternative to Epidural Blood Patch in Treatment of Postdural Puncture Headache: A Randomized Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Postdural Puncture Headache
Lead sponsor: Al-Azhar University
Sponsor class: OTHER
Collaborators: name: Benha University
First posted: 2024-02-21
Enrollment: 75
Sex: ALL
Minimum age (years): 21
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Lumbar puncture (LP), often known as a "spinal tap," is a standard medical technique pioneered in the late 1900s by Heinrich Quincke. It involves the retrieval and analysis of cerebrospinal fluid (CSF) from the spinal cord, serving as the benchmark for diagnosing conditions like subarachnoid hemorrhage, meningitis, and specific neurological conditions. Pregabalin, an anticonvulsant medicine that blocks calcium entry, is used to treat a variety of diseases. It has been used to relieve pain in a variety of patient groups, including those with chronic pain, epilepsy, and anxiety disorders


Eligibility criteria: Inclusion Criteria:

* age from 21 to 65 years old,
* both genders,
* confirmed diagnosis of postdural puncture headache (PDPH)

Exclusion Criteria:

* patient refusal
* known allergy to the drug used in the study
* patients with a history of convulsions
* chronic headaches
* contraindications to regional anesthesia (such as local infection and coagulation abnormalities).
* Clinical indications of elevated intracranial pressure or associated risk factors
* Deteriorated patients

Primary outcomes:
measure: the incidence of complete relief
timeFrame: 48 hours
Secondary outcomes:
measure: The intensity of the headache
timeFrame: 48 hours
Other outcomes:
Locations:
city: Tanta
country: Egypt
facility: Neveen Kohaf
Study officials:
References:
Clinical trial NCT06469086: Appendicoliths in Acute Complicated Appendicitis Patients With Abscess
Official title: Clinical Significance of Appendicoliths in Conservative Treatment of Acute Complicated Appendicitis Patients With Abscess: A Single-center Retrospective Study
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Acute Complicated Appendicitis With Abscess
Lead sponsor: Shanghai Zhongshan Hospital
Sponsor class: OTHER
First posted: 2024-06-21
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Acute complicated appendicitis patients with absces swho met the criteria.

Brief summary: Complicated appendicitis, characterized by the presence of an abscess or perforation, involves acute inflammation of the peritoneum secondary to an infection of the appendix, presenting additional challenges for management. Traditionally, the standard treatment for complicated appendicitis has been surgical intervention. However, conservative management, involving antibiotics and drainage, has emerged as a viable alternative for selected patients. Recent studies emphasize the importance of selecting appropriate antibiotics based on local resistance patterns and the patient's clinical condition. Broad-spectrum antibiotics, including those targeting anaerobic bacteria, are often preferred. In addition, advances in imaging technology, such as ultrasound-guided drainage, have improved the precision and success rates of percutaneous abscess drainage. This minimally invasive approach helps manage localized infections and can prevent the need for immediate surgery.

One factor that has gained significant attention in determining the success of conservative treatment for acute complicated appendicitis is the presence of appendicoliths-calcified deposits within the appendix. This study aims to investigate the clinical significance of appendicoliths in the conservative management of acute complicated appendicitis with abscesses.


Eligibility criteria: Inclusion Criteria:

* Patients who aged ≥18 years, who diagnosed as acute appendicitis clinically, who had peri-appendiceal abscess larger than 2 cm in diameter on CT scan, who agreed conservative treatment first, who refused immediate emergency surgery

Exclusion Criteria:

* Patients younger than 18 years, those with malignancies, those with incomplete clinical or pathological records were excluded from the study

Primary outcomes:
measure: The success rate of conservative treatment
timeFrame: January 01, 2025 to December 31, 2025.
Secondary outcomes:
measure: Postoperative complications
timeFrame: January 01, 2025 to December 31, 2025.
measure: Length of postoperative hospital stay
timeFrame: January 01, 2025 to December 31, 2025.
measure: The surgical approach used
timeFrame: January 01, 2025 to December 31, 2025.
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02528786: Blood Sample Collection Study for Pharmacogenomic Characterization of Participants That Previously Received Namilumab in M1-1188-002-EM (PRIORA, [NCT01317797]) Study
Official title: A Phase 1, Single-Time Blood Sample Collection Study for Pharmacogenomic Characterization of Subjects That Previously Received Namilumab and Participated in the Phase 1 PRIORA Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Rheumatoid Arthritis
Keywords: Drug therapy
Lead sponsor: Takeda
Sponsor class: INDUSTRY
First posted: 2015-08-19
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this study is to obtain blood samples from up to 14 participants who previously received namilumab in the previous study M1-1188-002-EM (PRIORA, \[NCT01317797\]) to correlate genetic markers with clinical outcomes.

Detailed description: Participants who received treatment with namilumab in the previous study M1-1188-002-EM (PRIORA \[NCT01317797\]) will have two whole blood samples (3 mL each) collected to correlate genetic markers with namilumab treatment responses as determined in the previous study.

The study will enroll approximately 14 participants who received namilumab in the previous study.

• No intervention is administered in this study.

This trial will be conducted in Bulgaria, Spain and The Netherlands. The overall time to participate in this study is 1 day.

Eligibility criteria: Inclusion Criteria:

1. The participant (or, when applicable, the participant's legally acceptable representative) voluntarily signs and dates a written, informed consent form and any required privacy authorization prior to the initiation of any study procedures.

Exclusion Criteria:

1. Did not receive namilumab during the PRIORA study (A phase Ib double-blind, placebo controlled, randomized, dose-escalating study).
2. Participants without any response time point recorded 4-week after the last dose of namilumab and beyond this time point
3. Participants who were excluded from post-hoc analysis due to protocol violations during the previous PRIORA study.

Primary outcomes:
measure: Number of Participants in Each Cluster
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Takeda
name: Medical Director Clinical Science
role: STUDY_DIRECTOR
References: