louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00001992: A Phase I Study of the Safety and Immunogenicity of Rgp 120/HIV-1IIIB Vaccine in HIV-1 Seropositive Adult Volunteers
Official title: A Phase I Study of the Safety and Immunogenicity of Rgp 120/HIV-1IIIB Vaccine in HIV-1 Seropositive Adult Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: HIV Infections
Keywords: Vaccines, Synthetic
Drug Evaluation
Acquired Immunodeficiency Syndrome
AIDS Vaccines
Lead sponsor: NIH AIDS Clinical Trials Information Service
Sponsor class: INDUSTRY
First posted: 2001-08-31
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: PREVENTION

Brief summary: To test the safety and immunogenicity of rgp 120/HIV-1IIIB vaccine in HIV-1 seropositive adult patients.


Eligibility criteria: Inclusion Criteria

Patients must have the following:

* Stage 1 or 2 Walter Reed clinical staging of HIV infected individuals.
* The ability to understand and sign a written informed consent form, which must be obtained prior to study entry.
* Be available for 24 weeks so that follow up may be completed.
* Qualify for care as Department of Defense health care beneficiary.

Exclusion Criteria

Co-existing Condition:

Patients with the following conditions or symptoms are excluded:

* Prior history of clinically significant cardiac, pulmonary, hepatic, renal, neurologic or autoimmune disease, other than HIV-1 infection, and in less than average general health as determined by a medical history, physical examination, and the required laboratory test results.

Concurrent Medication:

Excluded:

* Corticosteroids or other known immunosuppressive drugs.
* Any experimental agents.

Patients with the following are excluded:

* Prior history of clinically significant cardiac, pulmonary, hepatic, renal, neurologic or autoimmune disease, other than HIV-1 infection, and in less than average general health as determined by a medical history, physical examination, and the required laboratory test results.

Prior Medication:

Excluded within 30 days of study entry:

* Zidovudine or other anti-retroviral agents.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Rockville
country: United States
facility: Walter Reed Army Institute of Research
state: Maryland
Study officials:
References:
Clinical trial NCT01914692: Application of Somatostatin for Advanced Gastric Cancer After D2 Lymph Node Dissection
Official title: Application of Somatostatin for Advanced Gastric Cancer After D2 Lymph Node Dissection -a Prospective Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Gastric Cancer After D2 Lymph Node Dissection
Lead sponsor: First Affiliated Hospital, Sun Yat-Sen University
Sponsor class: OTHER
First posted: 2013-08-02
Enrollment: 2
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Gastric cancer radical surgery related complications are common.Somatostatin is a conventional medical therapy for bleeding.This study explore the effect of Somatostatin for Advanced Gastric Cancer After D2 Lymph Node dissection.


Eligibility criteria: Inclusion Criteria:

1. More than eighteen years old
2. Gastric cancer diagnosed by pathological examination
3. Be given informed consent
4. Without diabetes/hyperthyroidism/Damages of functions of heart, liver and kidney/Systemic Infection/immunodeficiency

Exclusion Criteria:

1. Contraindication of vascular puncture operation
2. Patients who refused to take part in the programe
3. Poor compliance of treatment
4. Malnutrition,BMI\<18
5. with pancreatectomy

Primary outcomes:
measure: fistula of pancreas
timeFrame: one year
Secondary outcomes:
measure: amount of bleeding
timeFrame: six months
measure: seroperitoneum
timeFrame: six months
measure: infection of incisional wound
timeFrame: one year
Other outcomes:
measure: postoperative pancreatitis
timeFrame: one year
Locations:
Study officials:
affiliation: First Affiliated Hospital of Sun Yat-sen University
name: Song Wu, Doctor
role: STUDY_CHAIR
References:
Clinical trial NCT05745792: Clinico-immunological Characterization and Immune Tolerance Breakdown in HU-autoimmunity
Official title: Clinico-immunological Characterization and Immune Tolerance Breakdown in HU-autoimmunity
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Immune Tolerance
Keywords: PARANEOPLASTIC NEUROLOGICAL DISORDERS
LUNG CANCER
HU AUTOIMMUNITY
IMMUNE TOLERANCE BREAKDOWN
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2023-02-27
Enrollment: 400
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients harboring Hu Abs in serum and/or CSF with or without cancer

Brief summary: Phenotypic characterization of patients with Hu-Abs, including the different neurological presentation and the presence or not of an underlying cancer.

Analysis and clinical correlation of the diagnostic techniques for Hu-Abs detection (immunofluorescence, immunodot/Western blot, and CBA) in serum and/or CSF.

Genomic and transcriptomic features of tumors (histological and immune infiltrate characteristics, transcriptomic profile, mutational status).


Eligibility criteria: * Inclusion Criteria \* :

  * Patient with neurological disorder
  * Patient with Hu antibody in sera or CSF
* Exclusion Criteria \* :

  * Patient with no data
  * Patient without neurological disorder
  * Patient without Hu antibody in sera/CSF

Primary outcomes:
measure: Modified Rankin Scale (mRs)
timeFrame: At 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Lyon
country: France
facility: Centre de référence des syndromes neurologiques paranéoplasiques et encéphalites autoimmunes
Study officials:
References:
Clinical trial NCT05056792: Efficacy of Plyometric Training Isometric Strength Training on Quadriceps Strength and Functional Performance.
Official title: Effects of Plyometric Training vs. Isometric Strengthening of Quadriceps on Strength, Sprint Test, and Single-Leg Triple Hop Test in Soccer Players
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Football Players
Keywords: Strength Resisted sprint training
Plyometric training
Function performance
Resisted sprint training
Lead sponsor: Majmaah University
Sponsor class: OTHER
First posted: 2021-09-27
Enrollment: 60
Sex: MALE
Minimum age (years): 18
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled trial
Primary purpose: PREVENTION

Brief summary: This study aims to investigate the influence of an eight-week plyometric and quadriceps strength training program on muscular strength, sprint, and functional performance in collegiate football players.

Detailed description: Sixty collegiate football players aged 18-25 years were recruited, at the university campus. All of them were randomly divided into two experimental and control groups that participated in training for six weeks on alternate days (i.e., three sessions per week), and one control group (n=30) did not train. The control group was instructed to maintain regular activities and avoid any strenuous physical activity during the study.

Under the Declaration of Helsinki, participants were informed about the study's possible risks and benefits, and all participants signed informed consent before participation in the study. The ethical sub-committee of the College of applied medical science, Majmaah, Saudi Arabia approved this study (Ethics Number: MUREC-Jan. 25/COM-2021 / 19-5).

Eligibility criteria: Inclusion Criteria:

• Young players aged between 18 and 25 years required frequent sprinting

Exclusion Criteria:

* Current injury to the lower limb.
* Surgery affecting lower limb function.
* Any cardio-respiratory diseases.
* Impairments of the spine or lower extremities.

Primary outcomes:
measure: Maximal Voluntary Isometric Contraction Strength (STN)
timeFrame: After 8 weeks of intervention
measure: Sprint Test (ST)
timeFrame: After 8 weeks of intervention
measure: Single-Leg Triple Hop Test (SLTH)
timeFrame: After 8 weeks of intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Al Majma'ah
country: Saudi Arabia
facility: Physiotherapy and Rehabilitation center
state: Riyadh
Study officials:
affiliation: Majmaah University
name: Shahnaz Hasan, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06666244: Carbohydrate Quality, Quality of Life, and Menopausal Symptoms in Postmenopausal Women
Official title: Evaluation of the Effect of Carbohydrate Quality on Quality of Life and Menopausal Symptoms in Postmenopausal Women
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Woman
Keywords: Carbohydrate Quality
Quality of life
Menopausal Symptoms
Lead sponsor: Ankara Yildirim Beyazıt University
Sponsor class: OTHER
First posted: 2024-10-30
Enrollment: 604
Sex: FEMALE
Minimum age (years): 30
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Community sample in Ankara, Turkey

Brief summary: This study aimed to evaluate the effect of carbohydrate quality on quality of life and menopausal symptoms in postmenopausal women. Data were collected from 604 postmenopausal women using a demographic questionnaire, the Menopause-Specific Quality of Life Questionnaire (MENQOL), and the Menopause Rating Scale (MRS). Carbohydrate quality was assessed using food frequency consumption data, and the results were analyzed with SPSS 24 software.

Detailed description: Objective: This study aimed to evaluate the effect of carbohydrate quality on quality of life and menopausal symptoms in postmenopausal women.

Method: A total of 604 postmenopausal women participated in the study. Participants completed a demographic questionnaire, the Menopause-Specific Quality of Life Questionnaire (MENQOL), and the Menopause Rating Scale (MRS). Carbohydrate quality was assessed using food frequency consumption data and analyzed based on dietary fiber, glycemic index, solid carbohydrate-to-total carbohydrate ratio, and whole grains-to-total grains ratio. Results were divided into five quartiles, with Q5 representing the highest and Q1 the lowest carbohydrate quality. Data analysis was conducted using SPSS 24 software.

Eligibility criteria: Inclusion Criteria:

* Women who have not menstruated for 12 consecutive months and have no intermenstrual bleeding
* Aged between 30 and 90 years
* Must be willing to volunteer

Exclusion Criteria:

* Women diagnosed with any psychological disorder
* Cancer patients

Primary outcomes:
measure: Evaluating carbohydrate quality
timeFrame: Basaline
Secondary outcomes:
measure: Menopause-Specific Quality of Life Questionnaire (MENQOL)
timeFrame: Basaline
measure: Menopause Rating Scale (MRS)
timeFrame: Basaline
measure: Sociodemographic characteristics
timeFrame: Basaline
measure: Body Mass Index (BMI)
timeFrame: Basaline
measure: Body weight
timeFrame: Basaline
measure: Height
timeFrame: Basaline
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Ankara Yıldırım Beyazıt University
Study officials:
References:
Clinical trial NCT02646644: Heterogeneity of Metastatic Neuroendocrine Tumors as Determined With 18F-dihydroxyphenylalanine-PET /CT, a Retrospective Analysis
Official title: Heterogeneity of Metastatic Neuroendocrine Tumors as Determined With 18F-dihydroxyphenylalanine-PET /CT, a Retrospective Analysis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Neuroendocrine Tumors
Lead sponsor: University Medical Center Groningen
Sponsor class: OTHER
First posted: 2016-01-06
Enrollment: 38
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: We will select the 18F- DOPA-PET scans conducted in the UMCG of adult patients with a metastasized intestinal NET between February 2014 until November 2015. Only patients of whose clinical data are available within the UMCG are included.

Brief summary: In an individual cancer patient extensive genetic and phenotypic variation exists between and within tumor lesions. Tumour load in NET patients can be measured with fluorine-18-L-dihydroxyphenylalaninepositron emission tomography (18F-DOPA-PET) scan.

This aim of the study is to investigate heterogeneity between tumor lesions within patients with intestinal NET by determining the differences in tracer uptake measured on a 18F- DOPA-PET scan retrospectively.

Detailed description: In an individual cancer patient extensive genetic and phenotypic variation exists between and within tumor lesions. Tumour load in NET patients can be measured with fluorine-18-L-dihydroxyphenylalanine positron emission tomography (18F-DOPA-PET) scan.

This aim of the study is to investigate heterogeneity between tumor lesions within patients with intestinal NET by determining the differences in tracer uptake measured on a 18F- DOPA-PET scan in retrospect.

Eligibility criteria: Inclusion Criteria:

* age ≥18 years
* diagnosis of intestinal NET diagnosed by a dedicated NET specialist
* more than one positive lesion on the 18F-DOPA-PET scan.
* available CT-scan within 6 months before or after the 18F-DOPA-PET-scan.

Exclusion Criteria:

* no clinical data available at the UMCG, besides the results of the DOPA PET scan.

Primary outcomes:
measure: tracer uptake in tumor lesions within patients with intestinal NET
timeFrame: at the day of scan
Secondary outcomes:
measure: tracer uptake in tumor lesions within patients with intestinal NET adjusted for uptake of background organ
timeFrame: at the day of scan
Other outcomes:
measure: the correlation of the magnitude of heterogeneity with ki 67
timeFrame: date of diagnosis until date of scan
Locations:
city: Groningen
country: Netherlands
facility: University Medical Center Groningen
Study officials:
affiliation: University Medical Center Groningen
name: A. M.E. Walenkamp, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00262444: Effectivity and Efficiency of Turning Frequencies: a Randomised Controlled Trial
Official title: Effectivity and Efficiency of Turning Frequencies: a Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pressure Ulcer Lesions (Grade 2 or More)
Lead sponsor: University Ghent
Sponsor class: OTHER
Collaborators: name: Distrac
First posted: 2005-12-06
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: Evaluation of the difference in pressure ulcer incidence or the time to develop pressure ulcers depending on the turning frequencies.

Detailed description: Evaluation of the difference in pressure ulcer incidence or the time to develop pressure ulcers depending on the turning frequencies.

Eligibility criteria: Inclusion Criteria:

* non-blanchable erythema above a bony prominence
* Informed consent

Exclusion Criteria:

* Pressure ulcers grade 3 or 4
* Turning contra-indicated based on medical grounds

Primary outcomes:
measure: Incidence of pressure ulcers
timeFrame: during 5 weeks
measure: Time to develop pressure ulcers
Secondary outcomes:
measure: Different risk factors: age, length, weight, incontinence, urinary catheter, blood pressure, mobility, activity, diabetes, CVA, KATZ score, medication, duration in a sitting posture
Other outcomes:
Locations:
city: Ghent
country: Belgium
facility: University Hospital Ghent
Study officials:
affiliation: University Ghent
name: Tom Defloor, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Vanderwee K, Grypdonck MH, De Bacquer D, Defloor T. Effectiveness of turning with unequal time intervals on the incidence of pressure ulcer lesions. J Adv Nurs. 2007 Jan;57(1):59-68. doi: 10.1111/j.1365-2648.2006.04060.x.
Clinical trial NCT02560844: Cardiomyopathy Arrhythmia Risk Evaluation
Official title: Cardiomyopathy Arrhythmia Risk Evaluation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiomyopathy
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
First posted: 2015-09-25
Enrollment: 164
Sex: ALL
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 cardiomyopathy and primary prevention ICDs

Brief summary: This study will evaluate the prognostic utility of novel ECG markers of electrical instability in patients with cardiomyopathy.

Detailed description: Baseline ECG markers of electrical instability will be measured in patients with cardiomyopathy. These ECG markers will be evaluated from a clinical Holter recording. All patients will have a primary implantable cardioverter defibrillator (ICD) as part of their clinical care. Patients will be followed prospectively for 2 years to evaluate the primary outcome of appropriate ICD shocks. Multivariable modelling will be performed to determine whether the ECG markers of electrical instability independently predict the primary clinical outcome.

Eligibility criteria: Inclusion Criteria:

* cardiomyopathy, primary prevention ICD

Exclusion Criteria:

* brady-pacing requirement

Primary outcomes:
measure: Proportion of patients with appropriate implantable cardioverter defibrillator (ICD) shocks
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: University Health Network
state: Ontario
Study officials:
References:
citation: Chakraborty P, Suszko AM, Viswanathan K, Sheikholeslami K, Spears D, Adler A, Woo A, Rakowski H, Chauhan VS. Microvolt QRS Alternans in Hypertrophic Cardiomyopathy: A Novel Risk Marker of Late Ventricular Arrhythmias. J Am Heart Assoc. 2021 Dec 7;10(23):e022036. doi: 10.1161/JAHA.121.022036. Epub 2021 Dec 2.
Clinical trial NCT06325644: Well-Formulated Ketogenic Diet Polycystic Kidney Disease
Official title: Feasibility and Efficacy of a Well-Formulated Ketogenic Diet in Delaying Progression of Polycystic Kidney Disease in Patients at Risk for Rapid Progression
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Polycystic Kidney Disease
Lead sponsor: Ohio State University
Sponsor class: OTHER
First posted: 2024-03-22
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: This is a prospective study to determine ketogenic diet effect on htTKV, GFR, microalbuminuria. This is a single-center study of 20 patients with ADPKD and deemed high risk for progression to ESRD. This determined by combination of features of ADPKD and htTKV as assessed by prior computed tomography (CT) or MRI. Patients will be recruited from the Polycystic Kidney Disease (PKD) Clinic at Ohio State University Wexner Medical Center. Enrolled patients will have MRI for htTKV, urinary studies, blood tests at baseline, 6 months, and 52 weeks. Blood for GFR will be assessed three times over the course of the study including baseline, 6 months, and 1 year. Participants will follow ketogenic diet for 52 weeks. Investigatory diet team will manage the ketogenic diet.


Eligibility criteria: Inclusion Criteria:

* Age 18-65 years old
* Diagnosis of ADPKD by imaging and/or genetic testing
* GFR ≥ 25 mg/dl
* Patients at risk for rapid progression of ADPKD: Mayo Class 1C-1E along with any other high risk features including early decline in GFR, hypertension onset ≤ 35 years of age, urologic events ≤ 35 years of age, PKD 1 truncating mutation and PROPKD score of 4 or higher as determined by the treating physician
* No changes of medications within the last three months.
* Able to comply with dietary intervention
* Ability to sign informed consent

Exclusion Criteria:

* Patients currently being treated with Tolvaptan
* Diagnosed with diabetes.
* Pregnancy
* Contraindications to MRI
* Ketogenic diet within the last three months
* Severe kidney disease with GFR \< 25 mg/dl
* Unable to purchase food for the diet intervention
* Gastrointestinal disorders that will interfere with diet intervention
* Chronic alcohol or drug abuse

Primary outcomes:
measure: Finger Stick Beta-Hydroxybutyrate
timeFrame: Up to ~ 52 Weeks
measure: Finger Stick Glucose
timeFrame: Up to ~ 52 Weeks
Secondary outcomes:
measure: Blood Pressure
timeFrame: Time Frame: Up to ~ 12 Weeks
Other outcomes:
Locations:
city: Columbus
country: United States
facility: The Ohio State University
state: Ohio
Study officials:
References:
Clinical trial NCT06489444: Fecal Amino Acids，Gut Taste Receptors and Irritable Bowel Syndromes
Official title: Alterations in Nutrient-sensing Mechanisms May Play a Role in Symptom Generation in Patients With IBS
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Irritable Bowel Syndrome
Lead sponsor: Second Affiliated Hospital of Xi'an Jiaotong University
Sponsor class: OTHER
First posted: 2024-07-08
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with irritable bowel syndrome who met all inclusion and exclusion criteria and corresponding healthy controls admitted to the gastroenterology Department of the Second Affiliated Hospital of Xi 'an Jiaotong University

Brief summary: Clinical data, fresh feces and intestinal mucosal tissues of patients with diarrheal IBS were collected. High performance liquid chromatography, immunohistochemistry and immunofluorescence were used to study the amino acid levels in feces of patients with IBS, the expression of taste receptors in intestinal mucosa, and the correlation between symptoms of abdominal pain and diarrhea and the expression of taste receptors, so as to obtain the conclusion that "intestinal amino acid perception abnormalities exist in patients with IBS. And correlated with clinical symptoms."


Eligibility criteria: Inclusion Criteria:

* Patients with IBS who meet the Rome IV diagnostic criteria:

  1. that is, recurrent abdominal pain, with symptoms occurring at least 1 day per week or at least 3 days per month on average in the last 3 months, combining 2 or more of the following:

     1. related to defecation;
     2. accompanied by changes in the frequency of bowel movements;
     3. Accompanied by changes in fecal characteristics (appearance). (Symptoms appeared at least 6 months before diagnosis, and above diagnostic criteria were met in the last 3 months) 2. Age ≥18 years old.

Exclusion Criteria:

* 1. History of celiac disease and other organic intestinal diseases, metabolic diseases (thyroid dysfunction, diabetes, etc.); (2) Serious neurological, mental and psychological diseases, or accompanied by serious organ dysfunction; 3. Abdominal surgery; 4. Pregnant, possible pregnant and lactating patients; 5. History of colonoscopy in the past 1 year; 6. Declined to participate in the study.

Primary outcomes:
measure: Taste receptor expression was associated with symptom severity
timeFrame: 1 year
measure: Association between fecal amino acid levels and symptom severity in patients
timeFrame: 1year
Secondary outcomes:
Other outcomes:
Locations:
city: Xi'an
country: China
facility: The second affiliated hospital of xi'an jiaotong university
state: Shaanxi
Study officials:
References: