louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00327236: The Study of Immune Cell (T Cell) Activity in Patients With Paraneoplastic Neurologic Syndromes
Official title: Killer T Cell Activity in the Paraneoplastic Neurologic Syndromes
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Paraneoplastic Syndromes
Keywords: Paraneoplastic Neurologic Syndromes
Lead sponsor: Rockefeller University
Sponsor class: OTHER
First posted: 2006-05-18
Enrollment: 109
Sex: ALL
Minimum age (years): 1
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with paraneoplastic neurologic disease, diagnosed through the research lab of the PI, or from third party referrals in the NYC area.

Brief summary: The investigators believe that T cells, cells that are a part of the immune system, are what are causing the neurological problems while also attacking tumor cells. This protocol studies the clinical status of patients with paraneoplastic neurological disorder (PND) as well as their blood to understand the relationship between their neurological disease, their cancer, and their immune system.

Detailed description: Patients with paraneoplastic neurological disorders (PNDs) provide a unique model for studying tumor immunity and neuronal autoimmunity. We hypothesize that T lymphocyte autoimmune dysfunction is involved in the pathogenesis of the paraneoplastic neurological syndromes, and that killer T cells are involved in the targeting and successful killing of tumor cells in these cancer patients. Furthermore, we postulate that this activity may provide a model for autoimmune brain disease. We will assess the immune responses in PND patients, correlate these with the clinical data (time course of disease, symptoms and signs, disability), and collect and archive clinical data, serum and cells from PND patients for current and future studies into the basic immune system phenomenon present in PND patients.

Eligibility criteria: Inclusion Criteria:

* Neurological disease which is suspected to be paraneoplastic
* No known active additional malignancy other than non-melanoma skin cancer

Exclusion Criteria:

* Known central nervous system (CNS) metastasis
* Known active additional malignancy
* No pulmonary disease which limits daily activities

if leukapheresis: must be 14 or older no known hepatitis B or C, HIV, or syphilis (by history or prior negative tests) no known IV drug users HgB \> 8.5 WBC \> 3,500 platelets \> 100,000 INR \< 2

if large blood draw (1/2 to 1 unit; children 3 ml/kg) in lieu of leukapheresis: no known IV drug users HgB \> 10 WBC \> 3,500 platelets \> 100,000 INR \< 2

if lumbar puncture: platelets \> 120,000 INR \< 1.2 must be 14 or older

Primary outcomes:
measure: Immunologic responses to tumor antigens in vitro
timeFrame: throughout study
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Rockefeller University Hospital
state: New York
Study officials:
affiliation: Rockefeller University
name: Robert Darnell, MD, PHD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00834236: Proteiomic Fingerprints of Gastric Juice
Official title: Diagnosis of Gastroduodenal Diseases by Proteiomic Fingerprints of Gastric Juice
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gastric Cancer
Keywords: gastric cancer
proteomics
gastric juice
Lead sponsor: Kaohsiung Veterans General Hospital.
Sponsor class: OTHER
Collaborators: name: National Science and Technology Council, Taiwan
First posted: 2009-02-03
Enrollment: 76
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: No accurate, inexpensive and non-invasive test for gastric cancer screening is currently available. The investigators' recent study identified a1-antitrypsin and other proteins as potential biomarkers of gastric cancer in gastric juice. The aim of this study was to develop a novel non-invasive modality for detecting gastric cancer by measurement of biomarkers in gastric juice.

Detailed description: Patients and methods: The study consisted of two parts: (1) investigating the differences in gastric juice biomarker concentrations between gastric cancer patients and controls, and (2) screening gastric cancer using string test to obtain gastric juice followed by immunoassay for biomarker concentration.

Eligibility criteria: Inclusion Criteria:

* healthy subjects and gastric cancer patients documented by endoscopy.

Exclusion Criteria:

* the use of proton pump inhibitors or histamine-2 receptor antagonists within 4 weeks prior to the study
* coexistence of two kinds of gastroduodenal lesions
* coexistence of severe systemic diseases

Primary outcomes:
measure: Number of Participants With Accurate Diagnosis for Gastric Cancer
timeFrame: 2 months
Secondary outcomes:
Other outcomes:
Locations:
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Veterans General Hospital
Study officials:
affiliation: Kaohsiung Veterans Genaral hospital
name: Ping-I Hsu, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00164918: Role of Routine Nasogastric Decompression After Subtotal Gastrectomy
Official title: Role of Routine Nasogastric Decompression After Subtotal Gastrectomy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Cancer of Stomach
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
First posted: 2005-09-14
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of the study is to evaluate whether subtotal gastrectomy without post-operative nasogastric decompression is better in terms of early post-operative bowel function and chest complication.

Detailed description: Nasogastric decompression is an intra-operative routine in most of the time to facilitate exposure of operative field during elective subtotal gastrectomy, but whether it should be retained post-operatively is controversial. Nasogastric decompression helps to drain the gastric remnant in case there is edema around the gastrojejunostomy, ileus and delayed gastric emptying, which can theoretically relieve nausea and abdominal distension. Besides, it may help decrease diaphragmatic splintage and hence decrease chance of chest infection if ileus occurs. However, nasogastric intubation could cause patient discomfort; also it has been shown that it would cause gastroesophageal reflux which may be associated with chest complication. There have been studies showing that routine post-operative nasogastric decompression is not necessary for gastrectomy in general, but the role in subtotal gastrectomy for stomach cancer is not well defined.

Eligibility criteria: Inclusion Criteria:All patients suffering from carcinoma of stomach, decided for operation

* subtotal, D1/D2 dissection
* palliative resection

Exclusion Criteria:

* actively bleeding tumor
* perforation of tumor
* patient present with gastric outlet obstruction
* combine organ excision
* known diabetes with nephropathy

Primary outcomes:
measure: Bowel function and related symptoms early post-op
Secondary outcomes:
Other outcomes:
Locations:
city: Hong Kong
country: China
facility: Surgical Ward, Prince of Wales Hospital
Study officials:
affiliation: Chinese University of Hong Kong
name: Enders K.W. Ng, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06766318: Cryo-ultrasound Versus LASER Therapy on Ankle Sprain in Tennis Players
Official title: Cryo-ultrasound Versus LASER Therapy on Ankle Sprain in Tennis Players
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ankle (Ligaments); Instability (Old Injury)
Keywords: cryoultrasound
laser
Ankle sprain
Tennis players
Elite girl
Lead sponsor: October 6 University
Sponsor class: OTHER
First posted: 2025-01-09
Enrollment: 40
Sex: FEMALE
Minimum age (years): 12
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: OTHER

Brief summary: the effect cryo-ultrasound therapy and LASER therapy on the short-term recovery of tennis players with acute lateral ankle sprains.

Detailed description: Acute lateral ankle sprains are common injuries among athletes, but the optimal treatment strategies in elite athletes are still debated. This proof-of-concept study aimed to assess the impact of cryo-ultrasound therapy and LASER therapy on the short-term recovery of tennis players with acute lateral ankle sprains.

Eligibility criteria: Inclusion Criteria:

* Age ranged from 12-16 years.
* elite girls;
* semi-professional tennis players;
* I-II grade lateral ankle sprain injury;
* no persistent instability phenomena or chronic sprains;
* acute injury (within 2 weeks from trauma);
* no evidence of bone edema or skin disorder, once the area of intense pain in motion was delimited, the lack of neurological disturbances was investigated and assessed.

Exclusion Criteria:

* history of recurrent dislocation of the ankle or hyperlaxity of any joint;
* severe rheumatic diseases and/or collagen diseases;
* athletes who have received any form of local physical therapy and NSAIDs within the last 2 months prior to injury;
* athletes who admit to using steroids;
* any contraindication and/or limitation to the use of a physical agent modality (implantable electrophysiological devices, active neoplasms). Taking medications.
* Athletic adult.

Primary outcomes:
measure: Pain intensity a
timeFrame: 2 months
measure: Foot and Ankle Disability Index
timeFrame: 2 months
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Cairo University
city: Cairo
country: Egypt
facility: Kerolous Ishak Shehata Kelini
Study officials:
affiliation: AL-Zaytoonah University
name: Kerolous Ishak Kelini, PHD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02893618: A 5 Treatment Period Pharmacokinetic Study Evaluating Dose Proportionality and Food Effects of Diazoxide Choline Controlled-Release Tablet (DCCR)
Official title: A 5 Treatment Period Crossover Pharmacokinetic Study Evaluating Dose Proportionality and Food Effects of Diazoxide Choline Controlled-Release Tablet (DCCR)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Prader-Willi Syndrome
Lead sponsor: Essentialis, Inc.
Sponsor class: INDUSTRY
First posted: 2016-09-08
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Open label, parallel-group, single site, 5 treatment-period study with 4 dose levels of DCCR, 1 of which is administered both with and without food.

Detailed description: Open label, parallel-group, single site, 5 treatment-period study with 4 dose levels of DCCR, 1 of which is administered both with and without food, with a 10 Day washout period between treatments. There will be 8 treatment sequences with 4 subjects randomized to each.

Eligibility criteria: Inclusion Criteria:

* Ability to follow verbal and written instructions
* Informed consent form signed by the subject
* Completed screening within 7 days prior to dosing
* BMI between 18.5 and 35 kg/m2
* Generally healthy
* fasting glucose less than or equal to 100 mg/dL
* HbA1c less than or equal to 6%

Exclusion Criteria:

* Pregnancy or breast feeding
* absence of contraception
* administration of investigational drug within 1 month prior to screening
* anticipated requirement for prohibited medication (systemic corticosteroids or anti-diabetic medications)
* allergic reaction to or significant intolerance of diazoxide, thiazides or sulfonamides
* known type 1 or type 2 diabetes mellitus
* congestive heart failure
* gastric bypass surgery
* history of drug or alcohol abuse

Primary outcomes:
measure: Pharmacokinetic parameters: Cmax
timeFrame: up to 24 hours
measure: Pharmacokinetic parameters: AUC0-24
timeFrame: up to 24 hours
Secondary outcomes:
measure: Pharmacokinetic parameters: CL/F
timeFrame: up to 24 hours
measure: Pharmacokinetic parameters: Tmax
timeFrame: up to 24 hours
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00681018: Feeding Study in Premature Infants
Official title: Feeding Study in Premature Infants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Premature Infants
Keywords: premature
infants
Lead sponsor: Mead Johnson Nutrition
Sponsor class: INDUSTRY
First posted: 2008-05-20
Enrollment: 143
Sex: ALL
Maximum age (years): 40
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: To evaluate weight gain of preterm infants fed fortified human milk.


Eligibility criteria: Inclusion Criteria:

* premature infant
* birth weight less than/equal to 1250 g
* exclusively breast fed

Exclusion Criteria:

* metabolic or chronic disease
* major surgery
* ventilator dependent

Primary outcomes:
measure: Weight gain
timeFrame: 28 days
Secondary outcomes:
measure: Feeding tolerance
timeFrame: 28 days
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: The University of Arkansas for Medical Sciences
state: Arkansas
city: Jacksonville
country: United States
facility: University of Florida
state: Florida
city: Jacksonville
country: United States
facility: University of Florida
state: Florida
city: Plantation
country: United States
facility: Plantation General Hospital
state: Florida
city: St. Petersburg
country: United States
facility: All Children's Hospital
state: Florida
city: Oak Lawn
country: United States
facility: Advocate Hope Children's Hospital
state: Illinois
city: Park Ridge
country: United States
facility: Advocate Lutheran General Children's Hospital
state: Illinois
city: Omaha
country: United States
facility: Children's Hospital
state: Nebraska
city: Jamaica
country: United States
facility: Queen's Hospital
state: New York
city: Greenville
country: United States
facility: Pitt County Memorial Hospital
state: North Carolina
city: Wilmington
country: United States
facility: SEAHEC
state: North Carolina
city: Winston-Salem
country: United States
facility: Forsyth Medical Center
state: North Carolina
city: Falls Church
country: United States
facility: Fairfax Hospital
state: Virginia
city: Richmond
country: United States
facility: Virginia Commonwealth University
state: Virginia
Study officials:
affiliation: Mead Johnson Nutrition
name: Carol Lynn Berseth, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT05695118: Body Composition and Fatty Liver Disease
Official title: Analysis of the Prognostic Correlation Between Body Composition Analysis and Fatty Liver Progression in Patients With Fatty Liver Using Low-dose CT
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Fatty Liver
Keywords: CT
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2023-01-23
Enrollment: 150
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: This study investigates relationship between fatty liver prognosis and body composition analysis result based on non-contrast low dose CT in patients with fatty liver disease.


Eligibility criteria: Inclusion Criteria:

* metabolic dysfunction-associated fatty liver disease (fatty liver with overweight/obesity, or type II DM or other metabolic dysfunction)
* or non-alcoholic fatty liver disease with liver function test abnormality
* signed informed consent

Exclusion Criteria:

* chronic hepatitis B or C
* other disease related to fatty liver such as glycogen storage disease, lipodystrophy, familial combined hyperlipidemia, hypobetalipoproteinemia, Weber-Christian syndrome or abetalipoproteinemia
* on medication related to hepatic steatosis (tamoxifen, steroid, valproic acid, methotrexate, amiodarone)
* diabetes after pancreatectomy
* history of total parenteral nutrition in 6 months
* pregnancy or nursing mother

Primary outcomes:
measure: relationship between body composition analysis result from CT and liver fat fraction
timeFrame: 6 month after CT acquisition
Secondary outcomes:
measure: ratio of appropriate non-contrast low dose abdomen CT acquisition & analysis
timeFrame: 6 month after CT acquisition
measure: relationship between body composition analysis result from CT and hepatic fibrosis
timeFrame: 6 month after CT acquisition
measure: agreement between body composition analysis result from CT and bioelectrical impedance analysis (Inbody test)
timeFrame: 6 month after CT acquisition
Other outcomes:
measure: incidence of incidental finding
timeFrame: 6 month after CT acquisition
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Professor
name: Jeong Min Lee, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05058118: Evaluation of the Safety, Tolerability and Pharmacokinetics of Intravenous FL058 Administered in Healthy Subjects(SAD)
Official title: A Randomized, Double-Blind, Single-Dose, Placebo-Controlled Phase I Clinical Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of FL058 for Injection in Healthy Chinese Subjects.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Qilu Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2021-09-27
Enrollment: 54
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To evaluate the safety,tolerability and pharmacokinetics of single intravenous doses of FL058 in healthy Chinese subjects.


Eligibility criteria: Inclusion Criteria:

1. Healthy adults aged between 18 and 45 years (inclusive).
2. Body mass index (BMI) ranges from 19 to 26 kg/m2 (inclusive), and the body weight is ≥50kg.
3. Good general health as determined by the Investigator based on medical history, physical examination, vital signs, 12-lead ECG and clinical laboratory tests.
4. Provide voluntary written informed consent prior to any study procedures and are willing and able to comply with the prescribed treatment protocol and evaluations.

Exclusion Criteria:

1. Concurrent or history of clinically significant cardiovascular, hepatic, renal, endocrine, gastrointestinal, respiratory, psychiatric, neurologic and/or hematological disorders.
2. Positive screen result for HBsAg, HCV-Ab, or HIV-Ab at screening.
3. History of clinically significant food or drug allergy.
4. A QT interval corrected using Fridericia's formula \>450 msec.
5. eGFR\<90mL/min/1.73m2.

Primary outcomes:
measure: Number of patients with adverse events [Safety and Tolerability]
timeFrame: Day 1 to Day 7
Secondary outcomes:
measure: FL058 -Cmax
timeFrame: Up to 48 hours post-dose
measure: FL058 -AUC
timeFrame: Up to 48 hours post-dose
measure: FL058 -t1/2
timeFrame: Up to 48 hours post-dose
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Huashan Hospital affiliated to Fudan University
Study officials:
References:
Clinical trial NCT03099018: Comparison of Two Rapid Antigen Detection Tests for the Detection of Group-A Streptococcal Pharyngitis in Children
Official title: Comparison of Two Rapid Antigen Detection Tests for the Detection of Group-A Streptococcal Pharyngitis in Children
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pharyngitis
Keywords: GAS
pharyngitis
children
RADT
Lead sponsor: University Hospital, Geneva
Sponsor class: OTHER
Collaborators: name: Quidel Corporation
First posted: 2017-04-04
Enrollment: 1000
Sex: ALL
Minimum age (years): 3
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children 3 to 15 years old presenting to the PED with pharyngitis and Mc Isaac score ≥ 2

Brief summary: Group A streptococcal (GAS) pharyngitis in children represents a frequent diagnostic challenge in pediatric emergency departments, since isolated signs and clinical prediction rules are insufficient to accurately discriminate between GAS and non GAS infections. Rapid antigen detection tests (RADTs) therefore remain essential, simple and rapid tools, allowing for rapid GAS identification and prompt antibiotic prescription. However, their sensitivity is not optimal. The aim of the present study is to test the accuracy of a new fluorescent immunoassay (Sofia Strep A FIA) using the optical technology for GAS detection in children 3-15 years old with pharyngitis, compared to a standard RADT, using throat culture as the gold standard (or PCR for discrepant results, i.e. negative culture with any positive RADT).


Eligibility criteria: Inclusion Criteria:

* Patient age between 3 and 15 years
* Clinical diagnosis of pharyngitis
* McIsaac score ≥2

Exclusion Criteria:

* Antibiotic treatment in the two weeks preceding the consultation

Primary outcomes:
measure: Diagnostic accuracy of the new Sofia Strep A FIA test in children with pharyngitis
timeFrame: 1 hour
Secondary outcomes:
measure: Diagnostic accuracy of the new Sofia Strep A FIA test in children with pharyngitis stratified on the pretest probability of GAS infection (according to McIsaac scores)
timeFrame: 1 hour
Other outcomes:
Locations:
Study officials:
affiliation: University Hospital, Geneva
name: Laurence Lacroix, MD
role: PRINCIPAL_INVESTIGATOR
References: