louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05684861: Serum TWEAK Levels in Acne Vulgaris
Official title: Serum TWEAK Levels in Acne Vulgaris Patients Treated With Oral Isotretinoin
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Acne Vulgaris
Lead sponsor: South Valley University
Sponsor class: OTHER
First posted: 2023-01-13
Enrollment: 150
Sex: ALL
Minimum age (years): 10
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Evaluate the serum level of TWEAK in patients with AV and their relations before and after treatment with isotretinoin.

Detailed description: Acne vulgaris is a chronic inflammatory disease of the pilosebaceous follicles, characterized by comedones, papules, pustules, cysts, nodules, and occasionally scars. Its pathogenesis includes follicular hyperkeratinization, sebaceous hypersecretion due to androgen stimulation, follicular colonization by Propionibacterium acnes, immune and inflammatory responses. It affects the face, anterior chest, and upper back . Inflammation is regarded as a key component in the pathogenesis of acne . An increase in the activity of the pro inflammatory cytokine, interleukin (IL) 1, is observed before the beginning of hyperproliferation around the uninvolved follicles and is thought to trigger the activation of keratinocyte proliferation. Nuclear factor kappa beta (NF κβ) regulated mRNA gene levels of the cytokines tumour necrosis factor (TNF) α, IL 1 β, IL 8 and IL 10 levels also affected.

Isotretinoin (13-cis retinoic acid) is a synthetic analog of vitamin A. Its oral form is prescribed for severe cases which are resistant to other treatments.

Tumor necrosis factor (TNF)-like weak inducer of apoptosis (TWEAK) belongs to the TNF superfamily. It has an important role in the regulation of cell growth, apoptosis, angiogenesis, and immune reactions.

Eligibility criteria: Inclusion Criteria:

* Patients classified according to the global acne grading system(GAGS) into moderate, severe, and very severe cases

Exclusion Criteria:

* Pregnant and lactating women, patients with renal, GIT, skeletal, psychiatric, and endocrine disorders, sarcoidosis, and patients receiving drugs such as diuretics, multivitamins, anticonvulsants, glucocorticoids, erythromycin, estrogen compound pill were excluded.

Primary outcomes:
measure: serum level of TWEAK
timeFrame: 12 weeks
Secondary outcomes:
measure: evaluate the effect of systemic isotretinoin on serum TWEAK level
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Qinā
country: Egypt
facility: South Valley University
state: Qena
Study officials:
affiliation: South Valley University
name: Hassan M Ibrahim, professor
role: STUDY_DIRECTOR
References:
Clinical trial NCT03565861: Safety and Pharmacokinetics of NP10679 in Normal Healthy Volunteers
Official title: A Phase 1, Randomized , Double Blind, Single Ascending Dose Study to Investigate Safety, Tolerability and PK of NP10679 in Healthy Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Safety Issues
Lead sponsor: Neurop Inc.
Sponsor class: INDUSTRY
First posted: 2018-06-21
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: Adaptive design of placebo and up to six escalating doses of NP10679
Primary purpose: TREATMENT

Brief summary: This study assesses the safety, tolerability and pharmacokinetics of NP10679 when delivered intravenously in escalating dose levels in comparison to placebo.

Detailed description: NP10679 is a pH dependent inhibitor of the GluN2B subtype of the NMDA receptor. Compounds of this drug class are hypothesized to be beneficial in a number of central nervous system disorders, including brain ischemia associated with subarachnoid hemorrhage, severe pain, major depression and substance abuse disorders. This study uses a double blind, adaptive design approach to evaluate the safety, tolerability and pharmacokinetics of a single dose of NP10679 when delivered intravenously in up to six escalating dose levels in comparison to placebo.

Eligibility criteria: Inclusion Criteria:

* Male and female subjects aged 18 to 55 years
* Ability to understand the requirements of the study, provide written informed consent, abide by the study restrictions, and agree to return for the required assessments.
* If of child bearing potential (both men and women) must agree to use 2 forms of contraceptive methods for the duration of study.

Exclusion Criteria:

* Clinical laboratory values greater than or equal to 2 times the upper limit of normal.
* Recent history (within 2 yrs) or current tobacco use.

Primary outcomes:
measure: Incidence of adverse events as a measure of safety and tolerability
timeFrame: 8 days
Secondary outcomes:
measure: Plasma concentration of parent drug
timeFrame: 4 days
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Pharmaron CPC
state: Maryland
Study officials:
affiliation: Neurop Inc.
name: Robert Zaczek, Ph.D.
role: STUDY_CHAIR
affiliation: Pharmaron CPC
name: Paolo DePetrillo
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01956461: Effects of Teriparatide Therapy for Japanese
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Osteoporosis
Keywords: osteoporosis
BMD
teriparatide
nursing home
Lead sponsor: Tomidahama Hospital
Sponsor class: OTHER
First posted: 2013-10-08
Enrollment: 500
Sex: ALL
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Osteoporotic patients who admit to our hospital

Brief summary: In this study, the investigators would like to analyze the bone mineral density (BMD) , bone turnover makers, and fracture prevention effects of daily teriparatide in Japanese patients under clinical practice. The participants are treated in the investigators hospital, who are under severe osteoporotic condition.

Several determinants were reported to be related to subsequent BMD increase, such as baseline bone turnover markers (BTMs), low BMD at baseline, age, prior treatment, but comprehensive discussion is lacking. Specifically, there analyses were performed fragmentarily.

The main objective of this study is to reveal the determinants of subsequent BMD increase and fracture preventing effect by teriparatide.

Next, in Japan, as the baby boom generation retires, aging and depopulation occur rapidly. As a result, there is a lot of nursing home. But there are few reports concerning to the efficacy of teriparatide treatment in nursing home patients. The second objective is to reveal the efficacy of teriparatide for patients living nursing home, especially BMD changes, bone turnover makers change, and adverse events.

Detailed description: Registry criteria: Patients treated in the investigators hospital using teriparatide. Enrolled patients are severe osteoporosis; more than two previous osteoporotic fractures, low BMD (\< young adult mean 65%).

Interventions: blood analyses and dual-energy X-ray absorptiometry (DXA) every 4 months Informed consent: Written informed consent will be obtained. Sample size: Five-hundreds participants

Eligibility criteria: Inclusion Criteria:

* severe osteoporotic patients

Exclusion Criteria:

* cancer, hypercalcemia, etc (i.e. patients who could not use teriparatide)

Primary outcomes:
measure: The determinants related to BMD increase and fracture prevention for teriparatide treatment
timeFrame: Up to 36 months
Secondary outcomes:
measure: BMD and BTMs response, and fracture prevention effects of teriparatide for the patients in nursing home
timeFrame: Oct 2014
Other outcomes:
Locations:
city: Yokkaichi
country: Japan
facility: Tomidahama Hospital
state: Mie
Study officials:
References:
Clinical trial NCT03903861: Galactose Mediated Glycogen Resynthesis
Official title: Galactose Mediated Glycogen Resynthesis and the Effects on Metabolism During Subsequent Exercise
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Exercise
Lead sponsor: University of Birmingham
Sponsor class: OTHER
Collaborators: name: Dairy Management Inc.
First posted: 2019-04-04
Enrollment: 9
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: This study will compare short-term post-exercise muscle glycogen synthesis following combined galactose-glucose, glucose alone or galactose alone ingestion.

Detailed description: Lactose, the sugar contained within milk, consists of glucose and galactose. Post-exercise consumption of a carbohydrate mixture containing glucose with galactose has been shown to accelerate liver glycogen repletion as compared to glucose-only provision. However, the extent to which galactose-glucose combinations influence post-exercise muscle glycogen storage has yet to be determined.

Therefore, this study will investigate whether short-term muscle glycogen storage after strenuous endurance exercise is enhanced by combined galactose-glucose or glucose only ingestion as compared to the ingestion of galactose alone.

Eligibility criteria: Inclusion Criteria:.

* Body mass index in the range: 18.5 - 27.5 kg/m2
* Participates in endurance-based exercise (e.g. cycling, running, rowing) at least 3 times per week
* Aerobic fitness: VO2max \>45 ml/kg/min (men), \>40 ml/kg/min (women)

Exclusion Criteria:

* Lidocaine allergy
* Current participation in another scientific/clinical study
* Bleeding disorder/s
* Current or recent smoker to include vaping (last 60 days)
* Vegan
* Existence of food intolerances
* Poor recent health as indicated in the general health questionnaire
* Engage in uncommon eating practices (e.g. sustained periods of fasting)
* Diagnosed with galactosemia

Primary outcomes:
measure: Muscle glycogen synthesis rates (mmol/kg/dm/h)
timeFrame: 4 hours
Secondary outcomes:
measure: Carbohydrate oxidation rates (g/min)
timeFrame: Up to 90 minutes
measure: Fat oxidation rates (g/min)
timeFrame: Up to 90 minutes
measure: Plasma glucose (mmol/L)
timeFrame: Up to 6 hours
measure: Serum insulin (mU/L)
timeFrame: Up to 6 hours
measure: Plasma galactose (mmol/L)
timeFrame: Up to 6 hours
measure: Plasma lactate (mmol/L)
timeFrame: Up to 6 hours
measure: Plasma non-esterified fatty acids (mmol/L)
timeFrame: Up to 6 hours
measure: Plasma glycerol (umol/L)
timeFrame: Up to 6 hours
measure: Plasma glucagon (pmol/L)
timeFrame: Up to 6 hours
Other outcomes:
Locations:
city: Birmingham
country: United Kingdom
facility: School of Sport, Exercise and Rehabilitation Sciences
state: West Midlands
Study officials:
affiliation: University of Birmingham
name: Gareth Wallis, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00226161: Chronic Pain After Inguinal Herniorrhaphy
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Inguinal Hernia
Lead sponsor: University Hospital, Gentofte, Copenhagen
Sponsor class: OTHER
First posted: 2005-09-26
Sex: MALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to determine whether laparoscopic inguinal hernia repair leads to a lower incidence of chronic pain compared to open herniorrhaphy.


Eligibility criteria: Inclusion Criteria:

* Primary inguinal hernia

Exclusion Criteria:

* History of severe mental illness or chronic pain elsewhere

Primary outcomes:
measure: Chronic pain
Secondary outcomes:
measure: Recurrence of the hernia
Other outcomes:
Locations:
city: Hellerup
country: Denmark
facility: Department of Surgical Gastroenterology, Gentofte University Hospital,
Study officials:
affiliation: Gentofte University Hospital
name: Jacob Rosenberg, professor,dr.med,chief consul
role: STUDY_DIRECTOR
References:
Clinical trial NCT06230861: Effects of Quercetin on Cardiometabolic Outcomes
Official title: Effects of Quercetin Supplementation on Cardiometabolic Parameters
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cardiometabolic Syndrome
Lead sponsor: University of Central Lancashire
Sponsor class: OTHER
First posted: 2024-01-30
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Cardiovascular disease, type 2 diabetes mellitus and associated diseases combined are the leading health burden and cause of mortality worldwide; therefore, the necessity for an intervention is paramount. Dietary interventions to improve cardiometabolic health are highly sought after as they possess less risk than pharmacological drugs. It has been postulated that Quercetin may be beneficial in improving cardiometabolic outcomes. However, to date, no research has explored this using a placebo randomized intervention.


Eligibility criteria: Inclusion Criteria:

* Healthy
* Between 18 \& 65 years
* Non-smoker
* BMI \< 30
* Able to give informed consent

Exclusion Criteria:

* Pregnancy
* Diabetes or any other metabolic/ uncontrolled hypertensive conditions
* Food allergies to quercetin
* Habitual consumption of quercetin
* Not regularly taking medication or antioxidant supplements

Primary outcomes:
measure: Systolic blood pressure
timeFrame: Baseline
measure: Systolic blood pressure
timeFrame: 20 days
Secondary outcomes:
measure: Diastolic blood pressure
timeFrame: Baseline
measure: Diastolic blood pressure
timeFrame: 20 days
measure: Percent bodyfat
timeFrame: Baseline
measure: Percent bodyfat
timeFrame: 20 days
measure: Waist to hip ratio
timeFrame: Baseline
measure: Waist to hip ratio
timeFrame: 20 days
measure: Blood glucose
timeFrame: Baseline
measure: Blood glucose
timeFrame: 20 days
measure: Blood triglycerides
timeFrame: Baseline
measure: Blood triglycerides
timeFrame: 20 days
measure: Triglyceride glucose index
timeFrame: Baseline
measure: Triglyceride glucose index
timeFrame: 20 days
measure: Blood cholesterol (Total, HDL & LDL)
timeFrame: Baseline
measure: Blood cholesterol (Total, HDL & LDL)
timeFrame: 20 days
measure: Coop-Wonka chart
timeFrame: Baseline
measure: Coop-Wonka chart
timeFrame: 20 days
measure: Beck Depression Inventory
timeFrame: Baseline
measure: Beck Depression Inventory
timeFrame: 20 days
measure: State Trait Anxiety Inventory
timeFrame: Baseline
measure: State Trait Anxiety Inventory
timeFrame: 20 days
measure: Insomnia Severity Index
timeFrame: Baseline
measure: Insomnia Severity Index
timeFrame: 20 days
measure: Pittsburgh Sleep Quality Index
timeFrame: Baseline
measure: Pittsburgh Sleep Quality Index
timeFrame: 20 days
measure: Epworth Sleepiness Scale
timeFrame: Baseline
measure: Epworth Sleepiness Scale
timeFrame: 20 days
Other outcomes:
Locations:
city: Preston
country: United Kingdom
facility: University of Central Lancashire
state: Lancashire
Study officials:
References:
Clinical trial NCT05383261: The Impact of the Social Factors and Rehabilitation Program to Address the Implications on Kidney Failure in Hail
Official title: The Impact of the Social Factors and Medical Rehabilitation Program to Address the Implications on Kidney Failure Disease in Hail Region (Under the Vision 2030)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Renal Disease
Keywords: Renal failure patients -Saudi community - social program
Lead sponsor: University of Hail
Sponsor class: OTHER
First posted: 2022-05-20
Enrollment: 75
Sex: MALE
Minimum age (years): 40
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: participants with CKD stages (3 and 4) will be participated in this study, their ages ranged from 40 to 60 years. Both sexes will be included.

Participants should be: Saudi persons living in Hail City, married, both genders,

Brief summary: The aims of our study to evaluate the effect of social factors and medical rehabilitation program on kidney function and quality of life among chronic kidney disease patients.

Detailed description: 1. This study aims to evaluate the effect of social factors and medical rehabilitation program on kidney function and quality of life among chronic kidney disease patients.
2. Identify the health problems facing patients with kidney failure in Hail region.
3. Detect the reality of the problems facing patients with kidney failure in Hail region and ways to reduce them.
4. Identify the family, psychological, economic and social problems facing patients with kidney failure in Hail region.

Eligibility criteria: Inclusion Criteria:

participants with CKD stages (3 and 4) will be participated in this study, their ages ranged from 40 to 60 years. Both sexes will be included.

Participants should be: Saudi persons living in Hail City, married, both genders,

Exclusion Criteria:

* (1) Severe chronic cardiac problems. (2) Chronic chest disease. (3) Chronic inflammatory orthopedic disorders and rheumatoid arthritis. (4) Mental impairments.

Primary outcomes:
measure: 6-minute walk test (6MWT). And Kidney Disease and Quality of Life (KDQOL™-36)
timeFrame: after 6 week
Secondary outcomes:
measure: muscle power of lower limb
timeFrame: after 6 week
Other outcomes:
Locations:
city: Hail
country: Saudi Arabia
facility: University of Hail
Study officials:
References:
Clinical trial NCT02813161: The Diabetic Foot Ulcer Registry
Official title: A Real World, Observational Registry of Diabetic Foot Ulcers and Quality of Care in Clinical Practice
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Diabetic Foot Ulcer Outcome
Quality of Patient Care
Keywords: diabetic foot ulcer
diabetes
arterial disease
neuropathy
amputation
QCDR
quality measure
wound
Lead sponsor: U.S. Wound Registry
Sponsor class: OTHER
Collaborators: name: APMA
First posted: 2016-06-24
Enrollment: 10000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Prospectively followed diabetic foot ulcers in the practice of clinicians submitting data to the registry

Brief summary: This is an observational, longitudinal real world registry of diabetic foot ulcers created from electronic health record data obtained in the course of clinical care. Data from certified electronic health records transmit data as part of the requirement to share data with a specialty registry under Objective 10 of Meaningful Use of an EHR.

Detailed description: This is an observational, longitudinal real world registry of diabetic foot ulcers created from electronic health record data obtained in the course of clinical care. Data from certified electronic health records transmit data as part of the requirement to share data with a specialty registry under Objective 10 of Meaningful Use of an EHR. No secondary data entry are required and all data are obtained via structured language from data entered in the EHR. Data from quality measures designed as electronic clinical quality measures (eCQMs) standardize the quality of care provided to patients and their clinical outcomes which are risk stratified using the Wound Healing Index (WHI). The eCQMs enable standardized data collection and the ability to transmit data electronically obviates the possibility of transcription errors. National benchmarking is possible since data are available from thousands of participants across the USA. While an independent IRB oversees this project, the data are collected for the purpose of measuring and improving the quality of care delivered to diabetic patients with foot ulcers and understanding their outcomes in relation to level of risk. Quality performance is reported as part of PQRS. These functions are exempt from the requirements of informed consent.

Eligibility criteria: Inclusion Criteria:

* All patients with diabetic foot ulcers seen by the practitioner

Exclusion Criteria:

* None

Primary outcomes:
measure: Wound healing
timeFrame: 6 months
measure: major amputation
timeFrame: 6 months
measure: minor amputation with preservation of ambulation
timeFrame: 6 months
measure: Death
timeFrame: 6 months
Secondary outcomes:
measure: Patient Quality of life
timeFrame: 12 weeks
measure: Patient Reported Outcome
timeFrame: 12 months
Other outcomes:
Locations:
city: The Woodlands
country: United States
facility: CHI St. Luke's The Woodlands
state: Texas
Study officials:
References:
Clinical trial NCT06571461: Liposomal Irinotecan in Combination With Oxaliplatin and S-1 Versus Gemcitabine Combined With Capecitabine as Postoperative Adjuvant Therapy for Pancreatic Cancer
Official title: A Randomized, Open-label, Multi-center Phase III Clinical Study of Liposomal Irinotecan Combined With Oxaliplatin and S-1 Versus Gemcitabine Combined With Capecitabine for Postoperative Adjuvant Treatment of Pancreatic Cancer
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE3
Conditions: Pancreatic Cancer
Lead sponsor: CSPC Ouyi Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2024-08-26
Enrollment: 408
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This study is designed as a phase III, two-arm, open-label, multi-center, randomized clinical trial comparing combination liposomal irinotecan, oxaliplatin and S-1 with gemcitabine + capecitabine when used as adjuvant therapy following resection for pancreatic ductal adenocarcinoma.
Primary purpose: TREATMENT

Brief summary: This study will evaluate the efficacy and safety of adjuvant therapy with liposomal irinotecan in combination with oxaliplatin, and S-1 compared with capecitabine combined with capecitabine in participants with pancreatic ductal adenocarcinoma after radical surgery.


Eligibility criteria: Inclusion Criteria:

1. Patients able and willing to provide a written informed consent aged 18-75 years.
2. Histologically confirmed resected ductal pancreatic adenocarcinoma (including adenosquamous carcinoma).
3. Undergone radical resection and confirmed macroscopic complete resection (R0 and R1).
4. Full recovery after surgery; able to start adjuvant treatment within 12 weeks after surgery.
5. Eastern Cooperative Oncology Group (ECOG) performance status 0-1.
6. The main organs function well.

Exclusion Criteria:

1. Patients with other types of non-ductal tumor of the pancreas, including endocrine tumors or acinar cell adenocarcinoma, pancreatoblastoma, and solid-pseudopapillary tumor.
2. Macroscopic incomplete tumor removal (R2 resection).
3. Prior neo-adjuvant treatment, radiation therapy, or systemic therapy for pancreatic adenocarcinoma.
4. Presence or history of metastatic or locally recurrent pancreatic adenocarcinoma.
5. CA 19-9\> 180 U / ml within 21 days before randomization.
6. The toxicity of previous therapy has not recovered to Grade 1 or below.
7. Known peripheral neuropathy (CTCAE ≥ Grade 2).
8. Known deficiency of dihydropyrimidine dehydrogenase (DPD)
9. Subjects with a confirmed diagnosis of Gilbert's syndrome

Primary outcomes:
measure: Disease-free survival (DFS)
timeFrame: Approximately 3 years.
Secondary outcomes:
measure: Overall survival (OS)
timeFrame: Approximately 5 years.
Other outcomes:
Locations:
Study officials:
References: