louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05561712: Method Optimization for the Quantification of the NAD
Official title: Method Optimization for the Quantification of the NAD (Nicotinamide Adenine Dinucleotide) Metabolome in Human Whole Blood, Plasma, and Urine, and Evaluation of Baseline Inter and Intra-subject Variability
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: NAD
Keywords: NAD quantification in blood and urine
Lead sponsor: Société des Produits Nestlé (SPN)
Sponsor class: INDUSTRY
First posted: 2022-09-30
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy volunteers

Brief summary: Method optimization for the quantification of the NAD metabolome in human whole blood, and evaluation of baseline inter and intra-subject variability.

Detailed description: Whole blood from healthy participants will be collected to optimize analytical method based on liquid chromatography tandem mass spectrometry (LC-MS/MS) for the analysis of the NAD metabolome in biological samples. Parameters such as collection volume and anti-coagulants will be investigated for optimal quantification. Moreover, inter- and intra-subject variability of NAD metabolite levels in whole blood will be evaluated. Plasma and urine will also collected for method development and variability measurements.

Eligibility criteria: Inclusion Criteria:

1. Healthy men and women (based on anamnesis),
2. Age between 18 and 55 years,
3. Body Mass Index (BMI) = weight (kg) / height (m)2 between 18.5 to 28 kg/m2.

Exclusion Criteria:

1. Pregnant or lactating women
2. Sick or with a strong cold
3. With vitamin B3 supplementations or under low carbohydrate of ketogenic diet
4. Under prescribed chronic medication, except contraceptive pill.

Primary outcomes:
measure: Comparison of NAD metabolite concentrations in whole blood, collected with different tubes and anticoagulants.
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
measure: Estimation of inter- and intra-subject variabilities of NAD metabolites in whole blood
timeFrame: through study completion, an average of 1 year
measure: Validation of the method for a set of NAD metabolites in plasma and urine (including determination of Limit Of Detection-LOD, Limit Of Quantification- LOQ).
timeFrame: through study completion, an average of 1 year
Other outcomes:
Locations:
city: Lausanne
country: Switzerland
facility: Clinical Innovation Lab.
Study officials:
affiliation: Nestle Health Science
name: Cuenoud Bernard
role: STUDY_DIRECTOR
References:
Clinical trial NCT02576912: Testing the Interactive Effects of Delta-9-Tetrahydrocannabinol and Pregnenolone
Official title: Testing the Interactive Effects of Delta-9-Tetrahydrocannabinol and Pregnenolone
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Cannabis
Marijuana
THC
Pregnenolone
Psychotic Disorders
PREG
Lead sponsor: Yale University
Sponsor class: OTHER
First posted: 2015-10-15
Enrollment: 38
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The overall purpose of this study is to examine the effect of pregnenolone (PREG) on the acute psychosis-like and cognitive effects of Delta-9-tetrahydrocannabinol (THC). This will be tested by pretreating healthy individuals with PREG and then assessing their responses to THC.


Eligibility criteria: Inclusion Criteria:

* Exposed to cannabis at least once in lifetime.

Exclusion Criteria:

* Cannabis naive
* Individuals with a documented reaction/allergy to Pregnenolone

Primary outcomes:
measure: Positive and Negative Syndrome Scale for Schizophrenia (PANSS)
timeFrame: Baseline, +110, +180, and +240 minutes after start of THC Infusion
Secondary outcomes:
measure: Clinician Administered Dissociative Symptoms Scale (CADSS)
timeFrame: Baseline; +15, +110, +180, and +240 minutes after start of THC infusion
measure: Visual Analog Scale (VAS)
timeFrame: Baseline; +15, +110, +180, and +240 minutes after start of THC infusion
measure: Psychotomimetic States Inventory (PSI)
timeFrame: Baseline; +110, +180, and +240 minutes after start of THC infusion
measure: Cognitive Test Battery
timeFrame: 25 minutes after start of THC infusion
Other outcomes:
Locations:
city: West Haven
country: United States
facility: Biological Studies Unit at the VA Connecticut Healthcare System, Yale School of Medicine
state: Connecticut
Study officials:
affiliation: Yale University
name: Deepak C D'Souza, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01305512: Pharmacokinetic, Safety and Tolerability Study of SPARC1028
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Solid Tumor in Advanced Stage
Keywords: Solid
Tumor
Taxane
Lead sponsor: Sun Pharma Advanced Research Company Limited
Sponsor class: INDUSTRY
First posted: 2011-02-28
Enrollment: 36
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: Evaluation of pharmacokinetic profile of SPARC1028

Detailed description: This is a phase I study of SPARC1028 and recommend phase II dose of SPARC1028 administered once a week for 3 weeks, followed by 1 week of rest.

Eligibility criteria: Inclusion Criteria:

* Histologically or cytologically confirmed diagnosis of solid tumor in advanced stage which taxane-based therapy is a rational treatment option.
* Age ≥18 years
* ECOG Performance Status ≤ 1.
* Estimated life expectancy of at least 12-weeks;

Exclusion Criteria:

* Any malignancy within past 5-years, except non-melanoma skin cancer, cervical intraepithelial neoplasia, or in situ cervical cancer
* Known hypersensitivity to the study drugs
* Treatment with any anti-cancer agents within 28 days of study entry
* Presence of clinically evident active CNS metastases, including leptomeningeal involvement, requiring steroid or radiation therapy

Primary outcomes:
measure: Determination of Maximum Tolerated Dose (MTD) during dose escalation
timeFrame: One 21-day treatment cycle
Secondary outcomes:
measure: Establishing pharmacokinectic profile at each dose level for SPARC1028
timeFrame: One 21-day treatment cycle
Other outcomes:
Locations:
city: Buffalo
country: United States
facility: SPARC Site 1
state: New York
Study officials:
References:
Clinical trial NCT02843412: The Clinical Study of Assessing HER-2 Expression in Gastric Cancer With Extra Tumor Tissue Paraffin Blocks Using Immunohistochemistry
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Gastric Cancer Surgical Specimens,18-80 Years Old, at Least Two Tumor Tissue Blocks
Keywords: Gastric cancer
Her2/neu
Dual paraffin blocks
Trastuzumab
Clinical Prospective Multicenter Cohort Study
Lead sponsor: Shanghai Zhongshan Hospital
Sponsor class: OTHER
First posted: 2016-07-25
Enrollment: 2000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Undergone curative surgery of gastric cancer, 18-80 years old

Brief summary: Background: Gastric cancer (GC) is major global health concern and the second leading cause of cancer deaths worldwide. Amplification of Her2/neu gene and/or overexpression of the Her2/neu protein have been observed in GC. Trastuzumab (Herceptin™) is an anti-Her2/neu antibody, which has been successfully applied in GC. However, the intratumoral heterogeneity of Her2/neu overexpression and amplification in GC should be noticed. The investigators investigated the significance of evaluating Her2/neu expression in different paraffin blocks of tumor tissue in GC.

Methods: 2000 GC patients from ten centers, patients were divided into a cohort using one tumor tissue paraffin block (cohort 1, n=1000) and a cohort using dual tumor tissue paraffin blocks (cohort 2, n=1000) when evaluating Her2/neu expression status by immunohistochemistry (IHC). In cohort 2, the investigators combined the results from two different paraffin blocks and used the higher one as the final score.


Eligibility criteria: Inclusion Criteria:

* Undergone curative surgery of gastric cancer,
* 18-80 years old.

Exclusion Criteria:

* None

Primary outcomes:
measure: compare the positive rate
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Xu C, Sun M, Jin M, Li Z, Qin R, Ren G, Sun W, Chen L, Luan L, Liu Y, Jiang D, Chen L, Luo R, Hou Y. Dual block HER2 assessment increased HER2 immunohistochemistry positive rate in resected specimens of gastric cancer: a prospective multicenter clinical trial from China. Diagn Pathol. 2022 Jun 28;17(1):54. doi: 10.1186/s13000-022-01230-7.
Clinical trial NCT03290612: Vitamin C to Reduce Morning Cardiovascular Risk
Official title: Chronotherapeutic Use of Vitamin C to Reduce Morning Cardiovascular Risk
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiovascular Risk Factor
Keywords: Sleep
Vitamin C
Lead sponsor: Oregon Health and Science University
Sponsor class: OTHER
First posted: 2017-09-25
Enrollment: 10
Sex: ALL
Minimum age (years): 40
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study will test the efficacy of Vitamin C to counteract morning cardiovascular (CV) risk markers in a randomized, double blind, placebo controlled crossover pilot study. The participants will also perform morning typical behaviors such as arousal from sleep, change in posture (getting out of bed) and mild intensity physical activity; identical to the stressors encountered in everyday life. Primary dependent variables are markers of cardiovascular risk including vascular endothelial function and oxidative stress.

Detailed description: The investigators plan to test the efficacy of Vitamin C to counteract morning cardiovascular (CV) risk markers in a randomized, double blind, placebo controlled crossover pilot study. The participants will also perform morning typical behaviors such as arousal from sleep, change in posture (getting out of bed) and mild intensity physical activity; identical to the stressors encountered in everyday life. This pilot study is in healthy middle aged adults without a history of CV disease.

Participants will spend two nights in an inpatient hospital suite at Hatfield Research Center. Upon awakening in the morning, they will either ingest Vitamin C or placebo in a randomized order. This will be followed by moderate intensity exercise, recovery, and discharge.

Eligibility criteria: Inclusion Criteria:

* Healthy participants
* Normal weight or overweight but not obese (18.5\<BMI\<33 kg/m2)

Exclusion Criteria:

* History of smoking/tobacco use
* Current prescription/non-prescription medications or drugs of abuse
* Acute, chronic, or debilitating medical conditions
* History of working irregular day and night hours, regular night work, or rotating shift work for the six months prior to the study.

Primary outcomes:
measure: Vascular Endothelial Function
timeFrame: Approximately three months
measure: Oxidative stress
timeFrame: Approximately three months
measure: Plasma Vitamin C and Tetrahydrobiopterin
timeFrame: Approximately three months
Secondary outcomes:
measure: Platelet aggregation
timeFrame: Approximately three months
measure: Plasminogen activator inhibitor -1
timeFrame: Approximately three months
Other outcomes:
Locations:
city: Portland
country: United States
facility: Oregon Health & Science University
state: Oregon
Study officials:
affiliation: Oregon Health and Science University
name: Saurabh S Thosar, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04263012: Establishment of a LVAD Destination Program in a Swiss Non Cardiac Transplant University Hospital
Official title: Establishment of a LVAD Destination Program in a Swiss Non Cardiac Transplant University Hospital: 5 Year Experience
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Heart Implant Complication
Keywords: left ventricular assist device (LVAD)
heart
implant
artificial
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
First posted: 2020-02-10
Enrollment: 20
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients who received an LVAD implant

Brief summary: The goal of this study is to demonstrate the challenges and the effort to set up an artificial heart program as well as to report about the follow-up treatment and the mortality rate


Eligibility criteria: Inclusion Criteria:

* Patients who received an LVAD implant

Exclusion Criteria:

* not enough data collected
* stated will of the Patient, that his data can not be used

Primary outcomes:
measure: 30 days mortality
timeFrame: 30 days after surgery
measure: rehospitalization rate
timeFrame: between day of surgery and 31.12.2019
Secondary outcomes:
measure: survival rate
timeFrame: between day of surgery and 31.12.2019
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: Herzchirurgie University Hospital Basel
Study officials:
affiliation: Herzzentrum Hirslanden Zürich
name: Martin Grapow, Prof Dr. med.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Schaeffer T, Pfister O, Mork C, Mohacsi P, Rueter F, Scheifele S, Morgen A, Zenklusen U, Doebele T, Maurer M, Erb J, Fassl J, Cueni N, Siegemund M, Pargger H, Gahl B, Osswald S, Eckstein F, Grapow M. 5-year results of a newly implemented mechanical circulatory support program for terminal heart failure patients in a Swiss non-cardiac transplant university hospital. J Cardiothorac Surg. 2021 Mar 31;16(1):64. doi: 10.1186/s13019-021-01447-5.
Clinical trial NCT01822912: Heart Failure Management Program Versus Usual Care
Official title: Evaluation of a Skilled Nursing Facility Heart Failure Disease Management Program Versus Usual Care
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiac Failure
Congestive Heart Failure
Keywords: Skilled Nursing Facility
Heart Failure
Transitional Care
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2013-04-04
Enrollment: 713
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Heart Failure (HF) patients discharged to Skilled Nursing Facilities have higher rehospitalization rates and mortality than patients discharged to home.

HF disease management programs have been shown to reduce rehospitalizations in community settings, no national guidelines have been set forth for Skilled Nursing Facilities (SNF).

This study will investigate the the effect of a heart failure-disease management program on the outcome of all-cause hospital readmissions, emergency room admissions and mortality for 30 days post-SNF admission using 7 component heart failure disease management program.


Eligibility criteria: Inclusion Criteria:

* Heart Failure is listed as the hospital discharge primary diagnosis
* Heart Failure is listed as the hospital discharge secondary diagnosis

Exclusion Criteria:

* Any life threatening condition which predicts mortality in 6 months or less

Primary outcomes:
measure: Change in 60 day post SNF admission outcomes
timeFrame: Up to 60 days post SNF admission
Secondary outcomes:
measure: Difference in health status and self-care 60 days post SNF admission
timeFrame: 60 days post SNF admission
measure: Change in Patients living at home 60 days post-SNF admission with Heart Failure (HF)
timeFrame: 60 days post SNF admission
measure: Difference in Cost-effectiveness
timeFrame: Up to 60 days post SNF admission
Other outcomes:
Locations:
city: Aurora
country: United States
facility: University of Colorado
state: Colorado
Study officials:
affiliation: University of Colorado, Denver
name: Rebecca Boxer, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lum H, Obafemi O, Dukes J, Nowels M, Samon K, Boxer RS. Use of Medical Orders for Scope of Treatment for Heart Failure Patients During Postacute Care in Skilled Nursing Facilities. J Am Med Dir Assoc. 2017 Oct 1;18(10):885-890. doi: 10.1016/j.jamda.2017.05.021. Epub 2017 Jul 6.
Clinical trial NCT06712212: Non-mesh Repair of Inguinal Hernia: Desarda Versus Darn
Official title: Non-mesh Repair of Inguinal Hernia: Desarda Versus Darn
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Inguinal Hernia Repair
Inguinal Hernia
Keywords: Hernia
Desarda repair
Darn repair
Inguinal Hernia
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2024-12-02
Enrollment: 30
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: To compare the results of Desarda and Darn techniques in inguinal hernia repair in Assiut University Hospital.

Detailed description: Inguinal hernia is one of the most common types of abdominal hernias with a prevalence of 75% of all abdominal hernias. Inguinal hernia repair is one of the most encountered surgeries all over the world. The use of mesh for inguinal hernia repair is the most commonly applied technique. However, being a foreign body, mesh repair has its own disadvantages. These include Postoperative hematoma and seroma, foreign body reaction, infection, mesh rejection, mesh migration, and fistula formation. Moreover, the use of mesh in potentially contaminated operating field is not advisable. Infectious complication and their consequences have restricted the use of mesh in emergency settings. In addition, mesh repair is not available in every part of the world since it increases the cost of the operation. Therefore, the non-mesh repair of inguinal hernia has been recently revisited. Different techniques for non-mesh inguinal hernia repair are available including Bassini, Shouldice, Desarda and Darn. In 2001,Indian Surgeon Dr. Desarda, introduced a novel technique of a tissue- based hernia repair without mesh with almost zero recurrence rates in which an undetached strip of the external oblique aponeurosis is sutured to the inguinal ligament below and the muscle arch above, behind the cord, to form a new posterior wall. External oblique muscle gives additional strength to the weakened muscle arch to keep this strip physiologically dynamic. In 1948, Moloney described a suture inguinal herniorrhaphy in which two layers of continuous monofilament non-absorbable suture lines with no tension were inserted. The first suture line is between the lower edge of the internal oblique muscle/aponeurosis and the inguinal ligament. The second superficial layer is between the rectus sheath and the inguinal ligament. All sutures should be placed without tension but with no slack .

Literature are deficient in comparing Desarda technique and Darn technique in the repair of inguinal hernia.

Eligibility criteria: Inclusion Criteria:

* inguinal hernia
* Age more than 18
* Male patients

Exclusion Criteria:

• simultaneous performance of other surgical procedures

Primary outcomes:
measure: Short term recurrence of hernia
timeFrame: From the day post operative to 6 months after the operation
Secondary outcomes:
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Assiut University
Study officials:
References:
Clinical trial NCT01591512: A Prospective Longitudinal Collection of Subjects Diagnosed With Small Cell Lung Cancer
Official title: A Prospective Longitudinal Collection of Subjects Diagnosed With Small Cell
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Small Cell Lung Cancer
Keywords: Small Cell Lung Cancer
SCLC
Lung Cancer
Subjects diagnosed with SCLC who will undergo treatment
Lead sponsor: Fujirebio Diagnostics, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Medical Research Networx LLC
First posted: 2012-05-04
Enrollment: 4
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Small cell lung cancer patients undergoing treatment.

Brief summary: The purpose of this study is to collect samples to evaluate the ProGRP and NSE assays independently as aids for monitoring the course of disease and therapy in subjects diagnosed with SCLC.


Eligibility criteria: Inclusion Criteria:

* Age ≥ 18
* Confirmed diagnosis of SCLC or mixed SCLC/non-SCLC per histopathology results
* Scheduled to undergo first-, second- or third-line treatment for SCLC, including chemotherapy, chemotherapy + radiation therapy, or combined concurrent chemoradiotherapy.
* Able to understand and willing to provide Informed Consent

Exclusion Criteria:

* No diagnosis of SCLC
* Not scheduled to undergo treatment for the diagnosis of SCLC
* Unable to provide Informed Consent

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Eastpointe
country: United States
facility: Kelly Family Medical Center, PC
state: Michigan
city: Bridgeton
country: United States
facility: St.Louis Cancer Care, LLP
state: Missouri
city: St. Joseph
country: United States
facility: Heartland Regional Medical Center
state: Missouri
city: St. Louis
country: United States
facility: Hematology Oncology Consultants, Inc.
state: Missouri
Study officials:
References:
Clinical trial NCT00418912: Family Study in Schizophrenia
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Schizophrenia
Family
Genetics
Lead sponsor: Sheba Medical Center
Sponsor class: OTHER_GOV
First posted: 2007-01-05
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: FAMILY_BASED
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: schizophrenia

Brief summary: Schizophrenia is a severe mental illness which is considered to have, among other, a genetic etiology. One of the most efficient tools in genetic-psychiatry is the investigation of multiplex families.

The current study will identify patients of multiplex families and to map their family connections and the presence of mental illnesses among family members.


Eligibility criteria: Inclusion Criteria:

1. Schizophrenia
2. Multiplex family
3. Able to understand and sign the informed concent form.
4. Hebrew speaker

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Tel Hashomer
country: Israel
facility: Psychiatric unit, Sheba Medical Center
city: Tel Hashomer
country: Israel
facility: Seba Medical Center
Study officials:
affiliation: Mental Health Epidemiology & Psychosocial Aspects of Illness, The Gertner Institute for Epidemiology and Health Policy Research, Sheba Medical Center, Tel Hashomer , Israel
name: Raz Gross, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Psychiatric Unit, Sheba Medical Center, Tel Hashomer, Israel
name: Michael Bunzel, MD
role: STUDY_DIRECTOR
References: