louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00975832: Adipocytokines and Polycystic Ovary Syndrome (PCOS)
Official title: Adipose Expression of Leptin, Adiponectin and IL-6, and Plasma Levels of Adipocytokines in Lean and Obese Women With PCOS
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Polycystic Ovary Syndrome
Keywords: The independent effect of PCOS and obesity on adipose expression and plasma levels of adipocytokines
Lead sponsor: Hvidovre University Hospital
Sponsor class: OTHER
Collaborators: name: Statens Serum Institut
name: Aarhus University Hospital
First posted: 2009-09-11
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 36 women (17 lean and 19 obese)with PCOS and 24 (8 lean and 16 obese) control women

Brief summary: Inflammation may play a role in the development of polycystic ovary syndrome (PCOS). In this study, the investigators investigated the expression of different mediators of inflammation in fatty tissue and in blood in women with and without PCOS.


Eligibility criteria: Inclusion Criteria:

* Women with PCOS were included according to the Rotterdam diagnostic criteria for PCOS. Control women met none of the criteria for PCOS

Exclusion Criteria:

* Oc´s within the last three months, or other medication known to alter glucose/insulin metabolism
* Other known chronic diseases

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Svendsen PF, Christiansen M, Hedley PL, Nilas L, Pedersen SB, Madsbad S. Adipose expression of adipocytokines in women with polycystic ovary syndrome. Fertil Steril. 2012 Jul;98(1):235-41. doi: 10.1016/j.fertnstert.2012.03.056. Epub 2012 May 16.
Clinical trial NCT00267332: Modafinil in Opioid Induced Sedation
Official title: A Randomized Double-Blinded, Placebo Controlled, Crossover Trial Examining the Effectiveness of Modafinil in Opioid Induced Sedation
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Cancer
Pain
Keywords: Sedation
Pain
modafinil
opioids
Lead sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Sponsor class: OTHER
First posted: 2005-12-20
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: * The primary objective of this study is to evaluate the efficacy of modafinil in the treatment of opioid induced sedation as measured by the Epworth Sleepiness Scale (ESS).
* The secondary objective is to estimate the frequency and severity of toxicity associated with Modafinil (400mg) in patients with opioid induced sedation.

Detailed description: Sedation is a common side effect of opioid analgesics. In patients where this remains a dose limiting toxicity, stimulants (caffeine, methylphenidate, ephedrine, amphetamine) have been the primary class of agents used to counteract sedation. Modafinil is a novel stimulant that is FDA approved for the treatment of narcolepsy and has a very different side effect profile than traditional stimulants. The potential role of this agent in the treatment of opioid induced sedation remains undefined. This study, which utilizes a prospective, randomized, blinded, cross-over design, will collect daily information on sedation (Epworth Sleepiness Scale), pain, opioid consumption, and adverse effects in 90 patients suffering from opioid induced sedation within the Johns Hopkins Medical Institutions.

Eligibility criteria: Inclusion Criteria:

* Epworth Sleepiness Scale \> 10
* Etiology of sleepiness is attributed only to opioids
* Patient must have been taking an opioid for more than 2 weeks or have been on a non-escalating dose of opioids for at least 1 week
* Patient must be able to give written informed consent
* Age \>18 years

Exclusion Criteria:

* Hypersensitivity to modafinil
* Mini-Mental Status Exam (MMSE) \< 25/30
* Renal impairment (calculated creatinine clearance \< 40)
* Hepatic dysfunction (total bilirubin \> 1.8, AST \> 75IU/l, ALT \> 100IU/l, prothrombin time \> 40%
* Known history of cardiovascular disease (i.e., left ventricular hypertrophy, ischemic ECG changes, chest pain, arrhythmia, mitral valve prolapse, recent myocardial infarction, unstable angina, uncontrolled hypertension)
* Woman who are pregnant, breast-feeding or on hormonal contraception
* Patients taking tricyclic antidepressants, CNS stimulants, hormonal contraceptives or drugs that are inhibitors or inducers of CYP 3A4

Primary outcomes:
measure: Sedation
measure: Pain
Secondary outcomes:
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: The Johns Hopkins Hospital
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Stuart A Grossman, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04831632: Diagnostic Performance Assessment of Qualitative Ifobt and Quantitative Ifobt for Advanced Neoplastic
Official title: Diagnostic Performance Assessment of Qualitative Ifobt and Various Quantitative Ifobt Cut-off Points for Advanced Neoplastic Wound Screening in an Argentine Patient Cohort
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Colorectal Neoplasms
Keywords: screening
colorectal cancer
fecal immunochemical test
FIT accuracy
Lead sponsor: Hospital El Cruce
Sponsor class: OTHER
Collaborators: name: Ministry of Public Health, Argentina
First posted: 2021-04-05
Enrollment: 630
Sex: ALL
Minimum age (years): 50
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: people who belong to Hospital El Cruce's coverage area

Brief summary: In Argentina, there is vast experience in qualitative iFOBT population screening that is part of the CRC Prevention and Early Detection National Program. The screening's cut-off point is at 50 ng/mL buffer. Its positivity rate for 2019 has been an average of 26.15%, over the double of the one reported in the international literature (7.5-11%) for this cut-off point (1). There are no studies that assess such technology and suggest an appropriate cut-off point for this population. The goal of this study is to assess the diagnostic performance of the qualitative iFOBT used in the present and the quantitative iFOBT with various cut-off points for advanced neoplastic wound screening (colorectal cancer and advanced adenoma) in an Argentine patient cohort.


Eligibility criteria: Inclusion Criteria:

* men and women aged 50-75
* Hospital El Cruce's coverage area and

Exclusion Criteria:

* those that have taken part in a previous VCC screening in the 5 past years or in a CRC screening program the year before the recruitment
* personal history of colorectal cancer or inflammatory bowel disease, personal or family history of syndromes of predisposition to known cancers, or family history of colorectal cancer in a first-degree relative aged less than 60
* those refuse to sign the consent form to take part in this study

Primary outcomes:
measure: diagnostic performance
timeFrame: 2 years
Secondary outcomes:
measure: qualitative iFOBT positivity rate
timeFrame: 2 years
Other outcomes:
Locations:
city: Florencio Varela
country: Argentina
facility: Hospital El Cruce
state: Buenos Aires
Study officials:
References:
Clinical trial NCT05501132: Efficacy of Intensified Transcranial Direct Current Stimulation in Obsessive-compulsive Disorder
Official title: Efficacy of Transcranial Direct Current Stimulation (tDCS) in Symptoms, Quality of Life, Cognitive Deficits and Brain Physiology of Patients with Obsessive-compulsive Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Obsessive-Compulsive Symptom
Lead sponsor: The National Brain Mapping Laboratory (NBML)
Sponsor class: OTHER
Collaborators: name: Ardabil University of Medical Sciences
name: Leibniz Research Centre for Working Environment and Human Factors
First posted: 2022-08-15
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a randomized, double-blind, parallel-group, sham-controlled trial that aims to investigate the effectiveness of transcranial direct current stimulation (TDCS) on improving symptoms, quality of life, depression, and cognitive functions in 39 patients with obsessive-compulsive disorder (OCD) that are randomized in 3 experimental groups.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of Obsessive-compulsive Disorder by a psychiatrist and DSM-5-based behavioral checklist
* being 18-50 years old
* providing written informed consent
* If female, negative urine pregnancy test
* stable medication regime especially the classical neuroleptics and all CNS-activating medications, if taken, 4-6 weeks before the experiment and during the experiment

Exclusion Criteria:

* smoker
* pregnancy
* alcohol or substance dependence
* history of seizure
* history of neurological disorder
* history of head injury
* presence of ferromagnetic objects in the body that are contraindicated for brain stimulation of the head (pacemakers or other implanted electrical devices, brain stimulators, some types of dental implants, aneurysm clips, metallic prostheses, permanent eyeliner, implanted delivery pump, or shrapnel fragments) or fear of enclosed spaces.

Primary outcomes:
measure: Yale-Brown Obsessive-Compulsive (Y-BOCS) rating scale
timeFrame: up to 1 month after the intervention
measure: Beck Anxiety Questionnaire (BAI)
timeFrame: up to 1 month after the intervention
measure: Response inhibition task 1
timeFrame: up to 1 month after the intervention
measure: Working memory task
timeFrame: up to 1 month after the intervention
measure: Response inhibition task 2
timeFrame: up to 1 month after the intervention
Secondary outcomes:
measure: Beck Depression Questionnaire (BDI-II)
timeFrame: up to 1 month after the intervention
measure: Quality of Life Questionnaire (WHOQUL)
timeFrame: up to 1 month after the intervention
measure: electroencephalogram (EEG) oscillatory power
timeFrame: up to 1 month after the intervention
measure: electroencephalogram (EEG) functional connectivity
timeFrame: up to 1 month after the intervention
Other outcomes:
Locations:
city: Ardabīl
country: Iran, Islamic Republic of
facility: Ardabil University of Medical Sciences
Study officials:
References:
Clinical trial NCT02611232: Incretin-based Therapy in Preclinical Type 1 Diabetes in Adults
Official title: Incretin-based Therapy in Preclinical Type 1 Diabetes in Adults
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Type 1 Diabetes
Keywords: Diabetes Type 1
Diabetes, Insulin-Dependent
Liraglutide
Preclinical Type 1 Diabetes
GLP-1 Analogue
Lead sponsor: University of Oulu
Sponsor class: OTHER
Collaborators: name: Oulu University Hospital
name: Tampere University Hospital
name: Turku University Hospital
First posted: 2015-11-20
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The main objectives of the trial are to study whether daily treatment with liraglutide improves insulin secretion and glucose metabolism, and whether liraglutide treatment is tolerable and safe in subjects with preclinical type 1 diabetes aged 18-30 years.


Eligibility criteria: Inclusion Criteria:

* 18-30 years of age
* positive for at least 2 biochemical islet autoantibodies
* have normal glucose tolerance in OGTT
* are not pregnant

Exclusion Criteria:

* allergic to liraglutide or other ingredients of Victoza®
* Type 1 diabetes
* diabetic ketoacidosis
* previous treatment in the last three months with any antidiabetic medication
* impaired liver or kidney function or on dialysis
* severe heart failure
* severe stomach or gut problem resulting in gastroparesis, or inflammatory bowel disease
* past or current history of pancreatitis
* serum calcitonin value above normal (\>50 ng/l or ≥3.4pmol/l)
* presence of any chronic metabolic, hematologic or malignant disease
* obesity BMI ≥30
* pregnant females and females of childbearing potential who are not using adequate contraceptive methods.
* breast-feeding

Primary outcomes:
measure: FPIR (first phase insulin response)
timeFrame: From baseline to 26 and 104 weeks
Secondary outcomes:
measure: Safety: serum and urine amylase, serum lipase, serum calcitonin, hypoglycemia
timeFrame: From baseline to 26 and 104 weeks
measure: Tolerability
timeFrame: From baseline to 26 and 104 weeks
measure: Serum C-peptide AUC
timeFrame: From baseline to 26 and 104 weeks
Other outcomes:
Locations:
city: Oulu
country: Finland
facility: University of Oulu and Oulu University Hospital
city: Tampere
country: Finland
facility: University of Tampere and Tampere University Hospital
city: Turku
country: Finland
facility: University of Turku and Turku University Hospital
Study officials:
affiliation: University of Oulu
name: Riitta Veijola, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kero J, Koskenniemi JJ, Karsikas S, Pokka T, Lou O, Toppari J, Veijola R. INnoVative trial design for testing the Efficacy, Safety and Tolerability of 6-month treatment with incretin-based therapy to prevent type 1 DIAbetes in autoantibody positive participants: A protocol for three parallel double-blind, randomised controlled trials (INVESTDIA). Diabet Med. 2022 Oct;39(10):e14913. doi: 10.1111/dme.14913. Epub 2022 Jul 22.
Clinical trial NCT05663632: Triglyceride-Glucose Index In Heart Failure Patients In Sohag University Hospital
Official title: Triglyceride-Glucose Index In Heart Failure Patients In Sohag University Hospital
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Heart Failure
Insulin Resistance
Keywords: heart failure
triglyceride-glucose index
Lead sponsor: Sohag University
Sponsor class: OTHER
First posted: 2022-12-23
Enrollment: 200
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients will be divided into2 groups, as following:

Group (1) Heart Failure patients (100 patients) Group (2) control group(100 person)

All groups will be subjected to :

1. Complete history taking with special emphasis on Age ,Sex, Smoking, Diabetes mellitus and Hypertension.
2. A thorough clinical examination will stress on:

1- Heart rate (b.p.m.). 2-Systolic BP (mmHg). 3-BMI calculated as the ( weight (kg)/height (m)2). 3-The following investigations will be done to every subject:

1. FBG (mg/dL)
2. FTG, (mg/dL)
3. Total cholesterol (TC) (mg/dL)
4. SCr (mg/dL)
5. Echocardiography

TyG index is calculated as ln \[fasting triglyceride (mg/dL) \* fasting glucose (mg/dL) / 2\]

Brief summary: study the relationship between Triglyceride glucose index and heart failure patients


Eligibility criteria: Inclusion Criteria:

* All Heart Failure patients attend to sohag university hospital aged above 18 year old .

Exclusion Criteria:

* Patients on lipid lowering medications
* Patients on antidiabetic drugs
* Patients with comorbidities eg liver cirrhosis or malignancy

Primary outcomes:
measure: Triglyceride-Glucose Index in Heart Failure Patients
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Sohag
country: Egypt
facility: Sohag University Hospital
Study officials:
References:
citation: GBD 2019 Diseases and Injuries Collaborators. Global burden of 369 diseases and injuries in 204 countries and territories, 1990-2019: a systematic analysis for the Global Burden of Disease Study 2019. Lancet. 2020 Oct 17;396(10258):1204-1222. doi: 10.1016/S0140-6736(20)30925-9.
citation: Davison B, Cotter G. Why is heart failure so important in the 21st century? Eur J Heart Fail. 2015 Feb;17(2):122-4. doi: 10.1002/ejhf.219. Epub 2014 Dec 30. No abstract available.
citation: Miller M, Seidler A, Moalemi A, Pearson TA. Normal triglyceride levels and coronary artery disease events: the Baltimore Coronary Observational Long-Term Study. J Am Coll Cardiol. 1998 May;31(6):1252-7. doi: 10.1016/s0735-1097(98)00083-7.
citation: Shaye K, Amir T, Shlomo S, Yechezkel S. Fasting glucose levels within the high normal range predict cardiovascular outcome. Am Heart J. 2012 Jul;164(1):111-6. doi: 10.1016/j.ahj.2012.03.023.
Clinical trial NCT05057832: Determination of Ustekinumab Levels in Patients With Crohn's Disease
Official title: Determination of Ustekinumab Levels in Patients With Crohn's Disease: Use in Clinical Practice
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Crohn Disease
Lead sponsor: Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
Sponsor class: OTHER
First posted: 2021-09-27
Enrollment: 95
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All patients treated with ustekinumab who have had their levels measured will be included.

Brief summary: Observational, prospective, single-center follow-up study carried out with patients from the area of the Virgen de Macarena University Hospital, diagnosed with chronic kidney disease, who started treatment with ustekinumab.

Detailed description: Prospective follow-up observational study carried out with patients from the Virgen de Macarena University Hospital, under treatment with ustekinumab in the induction and maintenance phase in order to determine the cut-off points of the ustekinumab levels between which a clinical remission is expected in patients with inflammatory bowel disease.

Eligibility criteria: Inclusion Criteria:

* Over 18 years.
* Patients treated with ustekinumab in induction and maintenance phase.
* They must agree to participate in the clinical study, having previously signed the informed consent.

Exclusion Criteria:

* Any patient who does not meet the inclusion criteria previously described and / or who refuses to participate in the study.

Primary outcomes:
measure: Determine breakpoints.
timeFrame: Up to 44 weeks.
Secondary outcomes:
Other outcomes:
Locations:
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen de Macarena
Study officials:
affiliation: Hospital Universitario Virgen Macarena
name: Federico Arguelles Arlas
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05043532: Randomized Trial for Optimal Number of Passes Required for Molecular Profiling During EUS-FNB of Pancreatic Cancer
Official title: Randomized Trial to Evaluate the Optimal Number of Passes Required for Molecular Profiling During Endoscopic Ultrasound-guided Fine Needle Biopsy of Pancreatic Adenocarcinoma
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pancreatic Cancer
Pancreatic Neoplasms
Adenocarcinoma of the Pancreas
Lead sponsor: Orlando Health, Inc.
Sponsor class: OTHER
First posted: 2021-09-14
Enrollment: 33
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: This is a randomized trial to evaluate the optimal number of passes required during endoscopic ultrasound-guided fine needle biopsy for molecular profiling in pancreatic cancer

Detailed description: Endoscopic ultrasound-guided fine needle tissue acquisition is currently the gold standard for sampling solid pancreatic masses. By using novel fine needle biopsy (FNB) needles during EUS-guided tissue sampling, core tissue samples can also now be obtained, with diagnostic adequacy of \>90%.

Molecular profiling is becoming increasingly important in the management of pancreatic adenocarcinoma for targeted therapy. As the procurement of core tissue is possible with EUS-FNB, adequate tissue can now be obtained for molecular profiling. However, the number of passes required during EUS-FNB to obtain sufficient quantity of core tissue to successfully perform molecular profiling is unknown, although usually 2-3 passes are performed as standard of care practice.

The primary aim of this study is therefore to elucidate the optimal number of passes required during EUS-FNB to procure adequate tissue for molecular profiling in patients with pancreatic adenocarcinoma.

Eligibility criteria: Inclusion Criteria:

1. Age 18 years and over
2. Suspected or confirmed pancreatic mass seen on imaging, requiring endoscopic ultrasound-guided fine needle biopsy

Exclusion Criteria:

1. Age \< 18 years
2. Females who are pregnant
3. Pancreatic mass is not accessible for fine needle biopsy via endoscopic ultrasound
4. Biopsied pancreatic mass is not adenocarcinoma on pathology

Primary outcomes:
measure: Rate of ability to perform successful molecular profiling in core tissue obtained during EUS-guided fine needle biopsy
timeFrame: 7 days
Secondary outcomes:
measure: Number of actionable mutations detected on molecular profiling
timeFrame: 7 days
measure: Rate of technical success
timeFrame: 1 day
measure: Rate of procedure-related adverse events
timeFrame: 7 days
measure: Type of actionable mutations detected on molecular profiling
timeFrame: 7 days
Other outcomes:
Locations:
city: Orlando
country: United States
facility: Orlando Health
state: Florida
Study officials:
affiliation: Orlando Health
name: Ji Young Bang, MD MPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01754532: Correlation Between Clinical Deterioration in Schizophrenic Patients and Hair Cortisol Levels
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Schizophrenia
Schizo-Affective Disorder
Keywords: Schizophrenia
Schizo-Affective Disorder
Stress
Cortisol
PANSS
Lead sponsor: Shalvata Mental Health Center
Sponsor class: OTHER
First posted: 2012-12-21
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients diagnosed with Schizophrenia or Schizo-Affective Disorder

Brief summary: The importance of stress as a possible deteriorating factor for schizophrenic patients is well documented. However, this notion is based on subjective experience and retrospective psychological analysis.

A novel method of measuring cortisol using hair has a proven correlation to subjective stress in non-clinical as well as psychiatric clinical populations.

This pilot study will attempt to assess the use of cortisol hair level, as a marker of stress, to predict clinical deterioration in schizophrenic patients.


Eligibility criteria: Inclusion Criteria:

* Age 18-50
* Diagnosis of schizophrenia or schizoaffective disorder, made by a senior psychiatrist.
* Signing an informed consent.

Exclusion Criteria:

* Additional psychiatric diagnosis
* Boldness or hair shorter than 1cm
* Physiological disturbance in the HPA or the use of steroidal medication
* Neurological disease (past or present) or neurosurgery.
* Pregnancy
* Substantial chronic physical diseases/

Primary outcomes:
measure: Change from Baseline in Positive And Negative Symptoms Score
timeFrame: 3 month
measure: Change from Baseline in Positive And Negative Symptoms Score
timeFrame: 6 month
Secondary outcomes:
measure: Change from Baseline in SANS, CGI, CDS, GAF and QOL Scores
timeFrame: 3 month
measure: Change from Baseline in SANS, CGI, CDS, GAF and QOL Scores
timeFrame: 6 month
Other outcomes:
Locations:
city: Hod Hasharon
country: Israel
facility: Shalvata MHC
Study officials:
affiliation: Shalvata MHC
name: Aviv Segev, MD
role: PRINCIPAL_INVESTIGATOR
References: