louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03125694: Sitagliptin vs. Pioglitazone as add-on Treatments in Patients With Type 2 Diabetes Uncontrolled on the Full-dose Metformin Plus Sulfonylurea
Official title: Efficacy, Durability, Safety, and Tolerability of Sitagliptin vs. Pioglitazone as add-on Treatments in Patients With Type 2 Diabetes Uncontrolled on the Full-dose Metformin Plus Sulfonylurea: a 52-week, Randomized, Open-label, Parallel-group, Phase 3 Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Uncontrolled Type 2 Diabetes Mellitus
Lead sponsor: Tehran University of Medical Sciences
Sponsor class: OTHER
First posted: 2017-04-24
Enrollment: 250
Sex: ALL
Minimum age (years): 25
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study has been designed to investigate the comparative effects of sitagliptin vs. pioglitazone as add-on treatments in patients with type 2 diabetes who were uncontrolled on the full-dose of metformin and sulfonylurea


Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of type 2 diabetes according to the American Diabetes Association
* Baseline level of 7% ≤ A1C \< 11% despite a minimum 6 months period of active treatment with metformin 2000 mg/day plus gliclazide 240 mg/day (uncontrolled type 2 diabetes)

Exclusion Criteria:

* Acute or chronic diseases of heart, lung, kidney,
* Active or past infectious conditions
* Malignancy

Primary outcomes:
measure: Change from baseline in mean glycated hemoglobin (A1C) levels by sitagliptin vs. pioglitazone
timeFrame: 52 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Tehran
country: Iran, Islamic Republic of
facility: Tehran University of Medical Sciences
Study officials:
References:
Clinical trial NCT06262594: Lemborexant Treatment of Insomnia Linked to Epilepsy
Official title: Lemborexant Treatment of Insomnia Linked to Epilepsy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Epilepsy
Sleep
Lead sponsor: University of Manitoba
Sponsor class: OTHER
Collaborators: name: Duke University
First posted: 2024-02-16
Enrollment: 26
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 goal of this clinical trial is to assess whether Lemborexant can improve sleep in patients with epilepsy.


Eligibility criteria: Inclusion Criteria:

* Sleep-related focal epilepsy
* Contraception

Exclusion Criteria:

* Changes in antiseizure medication 1 month before study protocol or during study protocol
* Concomitant medications per SUNRISE1
* Individuals with hepatic impairment
* Female participants who are pregnant or breastfeeding
* Individuals with compromised respiratory function
* Individuals with a history of complex sleep-related behaviour
* Individuals with rare hereditary diseases of galactose intolerance such as galactosemia or glucose-galactose malabsorption
* Individuals with a history of dependence or tolerance - abuse, dependence, rebound insomnia
* Individuals with psychiatric disorders with abnormal thinking and behavioural changes, depression, or suicidal ideation
* Individuals with a diagnosis of narcolepsy

Primary outcomes:
measure: WASO
timeFrame: 36 Days
Secondary outcomes:
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University
state: North Carolina
city: Winnipeg
country: Canada
facility: Health Sciences Centre
state: Manitoba
Study officials:
References:
Clinical trial NCT00619294: Endothelial Dysfunction and Coronary Artery Spasm
Official title: Digital Tonometry for Measurement of Peripheral Artery Reactive Hyperemia as Non-invasive Test for Diagnosis of Coronary Artery Spasm
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coronary Vasospasm
Keywords: Coronary Vasospasm
Endothelium, Vascular
Vasodilation
Hyperemia
Lead sponsor: Kumamoto University
Sponsor class: OTHER
First posted: 2008-02-20
Enrollment: 158
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Kumamoto University Hospital

Brief summary: Non-obstructive coronary artery disease (NOCAD) frequently accounts for myocardial ischemia in women. Endothelial dysfunction is a pathogenic factor in coronary spastic angina (CSA). CSA is an important cause of NOCAD diagnosed invasively by coronary angiography (CAG). Digital reactive hyperemia peripheral arterial tonometry (RH-PAT) provides noninvasive evaluation of endothelial dysfunction. The investigators hypothesized that the fingertip RH-PAT could predict the presence of CSA in women.

Detailed description: Outline of methods:

RH-PAT was measured in women with chest pain prior to CAG. Coronary spasm was diagnosed by intra-coronary acetylcholine (ACh) provocation test. Using Flow-Wire, we assessed coronary endothelial function by coronary blood flow increase in response to ACh (ACh-CBF) and coronary flow reserve was assessed by adenosine (Ad-CFR).

Eligibility criteria: Inclusion Criteria:

* Stable post-menopausal women complaining angina-like chest pain

Exclusion Criteria:

* Severe valvular disease
* Hypertrophic cardiomyopathy
* Severe peripheral artery disease
* Uncontrolled hypertension
* Severe collagen diseases
* Acute coronary syndrome

Primary outcomes:
measure: Ischemic heart disease diagnosed by cardiac catheterization
timeFrame: From Aug 2006 to May 2009
Secondary outcomes:
Other outcomes:
Locations:
city: Kumamoto
country: Japan
facility: Kumamoto University Hospital
Study officials:
References:
citation: Matsuzawa Y, Sugiyama S, Sugamura K, Nozaki T, Ohba K, Konishi M, Matsubara J, Sumida H, Kaikita K, Kojima S, Nagayoshi Y, Yamamuro M, Izumiya Y, Iwashita S, Matsui K, Jinnouchi H, Kimura K, Umemura S, Ogawa H. Digital assessment of endothelial function and ischemic heart disease in women. J Am Coll Cardiol. 2010 Apr 20;55(16):1688-96. doi: 10.1016/j.jacc.2009.10.073.
Clinical trial NCT06828094: Enteral Nutrition and Immune Proteins Study
Official title: The Effect of Exclusive and Partial Enteral Nutrition on Inflammation-related Proteins and on the Gut Microbiome of Healthy Adults
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Healthy Adults
Lead sponsor: University of Glasgow
Sponsor class: OTHER
First posted: 2025-02-14
Enrollment: 38
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Eligible healthy adults who consent to take part in the study will be randomised to receive either a specialised milkshake for all of their normal daily diet (exculsive enteral nutrition, EEN) or the same specialised milkshake for half of their normal daily diet (partial enteral nutrition, PEN) for seven days. This randomisation is to prevent any bias. In the week before the allocated diet starts participants will be asked to give a weight and height measurement, blood sample, collect a stool and urine sample, and complete a food diary of everything they eat and drink using household measurements (e.g., a teaspoon) seven, four, and one day before the randomly allocated diet begins. Participants will also be asked to give a weight measurement, blood sample, and collect a stool and urine sample before they start the allocated diet. All participants will be asked to collect a third stool, urine, and blood sample and weight measurement at the end of the seven days dietary intervention. Blood samples collected during the study will be used to find out how the cells and proteins which instruct the immune system change during the special milkshake diet. Stool and urine samples will be used to measure the levels of different bacteria which naturally live inside the gut and how their behaviour might have changed during the diet. Those allocated to have PEN will be asked to complete a second set of food diaries for three days during your seven days of specialised milkshake.


Eligibility criteria: Inclusion Criteria:

* Healthy adults (\>/= 18 years)

Exclusion Criteria:

* Those sufferring from acute or chronic illness (defined as illness which requires regular visits to health services)
* Those who have experienced weight changes +/- 2kg in the past month.
* Previous gut surgery,
* Use of antibiotics or steroids in the past month
* Food allergies which prevent consumption of the enteral nutrition used (milk protein allergy)
* Current pregnancy or breastfeeding.

Primary outcomes:
measure: Changes in Inflammation-Related Proteins
timeFrame: Seven days
Secondary outcomes:
measure: Changes in Immune Cell Populations
timeFrame: Seven days
measure: Changes in Gut Microbiome Composition
timeFrame: Seven days
Other outcomes:
Locations:
city: Glasgow
country: United Kingdom
facility: University of Glasgow
Study officials:
References:
Clinical trial NCT03246594: Oesophageal Probe Evaluation in RF Ablation of Atrial Fibrillation
Official title: Oesophageal Probe Evaluation in RF Ablation of Atrial Fibrillation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Atrial Fibrillation
Keywords: atrial fibrillation
esophageal probe
thermolesion
Lead sponsor: Heart Center Leipzig - University Hospital
Sponsor class: OTHER
First posted: 2017-08-11
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The Trial will evaluate the influence of oesophageal probes in Radio frequency (RF)-ablation of atrial fibrillation regarding oesophageal ulcers after ablation.

Detailed description: The Trial will evaluate the influence of oesophageal probes in RF-ablation of atrial fibrillation regarding oesophageal complications after ablation.

200 patients will be prospectively randomised into 2 groups. The conventional group will undergo RF-Ablation of atrial fibrillation using an oesophageal probe to measure the temperature during ablation.

In the other group will receive ablation using fixed energy levels (25 Watt) at the posterior left atrial (LA) Wall without an oesophageal probe , All patients will get a gastroscopy for evaluation of oesophageal complications the day after the procedure.

All patients will have a 6 months follow up (FU) in our clinic to be reevaluated for complications (primary endpoint) and rhythm stability. (secondary endpoint)

Eligibility criteria: Inclusion Criteria:

* 12 lead ECG with documented atrial fibrillation
* Indication for RF ablation of atrial fibrillation according to the recent guidelines
* Signed informed consent
* Age 18-85 years

Exclusion Criteria:

* Pregnancy or possible pregnancy without negative test within 48h prior to ablation
* Intracardiac thrombus
* Contraindication for oral anticoagulation
* Conditions, that may complicate the positioning of the oesophageal probe

Primary outcomes:
measure: Oesophageal complications after RF Ablation depending on using an oesophageal probe
timeFrame: Up to 6 months
Secondary outcomes:
measure: Rhythm stability after RF ablation of atrial fibrillation (AF)
timeFrame: 6 Months
Other outcomes:
Locations:
city: Leipzig
country: Germany
facility: Heart Center Leipzig
Study officials:
References:
citation: Schoene K, Arya A, Grashoff F, Knopp H, Weber A, Lerche M, Konig S, Hilbert S, Kircher S, Bertagnolli L, Dinov B, Hindricks G, Halm U, Zachaus M, Sommer P. Oesophageal Probe Evaluation in Radiofrequency Ablation of Atrial Fibrillation (OPERA): results from a prospective randomized trial. Europace. 2020 Oct 1;22(10):1487-1494. doi: 10.1093/europace/euaa209.
Clinical trial NCT05537194: Effects of Dihydropyridine Calcium Channel Inhibitors on Respiratory Gas Exchanges in the Intensive Care Unit: a Pharmacovigilance Study in VigiBase® and a Comparison With Urapidil
Official title: Effects of Dihydropyridine Calcium Channel Inhibitors on Respiratory Gas Exchanges in the Intensive Care Unit: a Pharmacovigilance Study in VigiBase® and a Comparison With Urapidil
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hypoxia
Lead sponsor: University Hospital, Caen
Sponsor class: OTHER
First posted: 2022-09-13
Enrollment: 32000000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Reports in VigiBase

Brief summary: Due to their effects on hypoxic pulmonary vasoconstriction (HPV), dihydropyridine calcium channel inhibitors (CCI) could lead to hypoxia in patients with a pulmonary shunt. To the present time only preclinical studies and case reports focused on this potential adverse drug reaction. We aimed to assess the reporting association between CCI and hypoxia using the World Health Organization pharmacovigilance database (VigiBase®).


Eligibility criteria: Inclusion Criteria:

* present in the database

Exclusion Criteria:

* chronology not compatible with the drug imputability

Primary outcomes:
measure: association between dihydropyridine CCI or urapidil and hypoxia
timeFrame: from the 01/01/1963 to the 14/08/2022
Secondary outcomes:
Other outcomes:
Locations:
city: Caen
country: France
facility: Caen University Hospital, Department of Pharmacology
state: Normandie
Study officials:
References:
Clinical trial NCT01121094: Fetal Parenchymatic Evaluation (Liver, Spleen) Using T2* Sequences
Official title: Fetal Parenchymatic Evaluation (Liver, Spleen) Using T2* Sequences.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Iron Overload
Keywords: Liver, spleen , T2* , MRI, fetus
Lead sponsor: Sheba Medical Center
Sponsor class: OTHER_GOV
First posted: 2010-05-12
Enrollment: 50
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This study will be offered to motheres undergoing fetal MRI for any indication.

Brief summary: The purpose of this study is to prospectively evaluated the T2\* values of normal feti.A standardized scale of T2\* values for fetal and neonatal iron organ overload have yet to be reported or devised.

Detailed description: The purpose of this study is to prospectively evaluate the T2\* values of normal feti. This study will be offered to mothers undergoing fetal MRI for any indication. Subjects will be required to sign an informed consent from. The addition of T2\* sequences will add 2-4 minutes to the whole scan, not exposing the mother or the fetus to ionizing radiation or the administration of contrast material. A standardized scale has been created and multi-center studies have been conducted using different vendor scanners in order to verify the consistency of these scale. T2 and T2\* sequences have been addressed anecdotally in the literature as non invasive options for the evaluation fetal iron deposition . However, a standardized scale of T2\* values for fetal and neonatal iron organ overload have yet to be reported or devised.

Eligibility criteria: Inclusion Criteria:

* Any MRI study for fetus

Exclusion Criteria:

* Known iron deposition problem in the mother of fetus

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Tel Hashomer
country: Israel
facility: Sheba medical center
Study officials:
References:
Clinical trial NCT05326594: Effects of Physical Therapy on Improving Disc Height, Postural Stability, Pain and Function in Persons With Discogenic Low Back Pain
Official title: Effects of Physical Therapy on Improving Disc Height Index, Postural Stability, Pain and Function in Persons With Discogenic Low Back Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Low Back Pain
Disk Prolapse
Lead sponsor: Foundation University Islamabad
Sponsor class: OTHER
First posted: 2022-04-13
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Lumbar degenerative disc disease and discogenic low back pain is comparatively common and disabling musculoskeletal condition, however there is no conclusive evidence regarding the positive effects of conservative physical therapy management in terms of radiological changes and improvement in disc height. For this reason, the current study will not only look into the positive effects of conservative physical therapy on postural stability, pain and function, but also in terms of disc height in persons with discogenic low back pain.


Eligibility criteria: Inclusion Criteria:

* Both male and female participants
* Aged 18-50 years old
* low back pain intensity less than 80/100mm on visual analogue scale
* positive centralization phenomenon
* low signal intensity of IV disc on T2 - weighted MRI
* high intensity zone towards the posterior aspect of the disc on MRI

Exclusion Criteria:

* Individuals with and any musculoskeletal, metabolic, or neurological disorders that may impair gait, postural stability or sensory integrity will be excluded from the study.

Primary outcomes:
measure: Back Pain
timeFrame: 2 weeks
measure: Lumbar Range of Motion
timeFrame: 2 weeks
measure: Postural Stability
timeFrame: 2 weeks
measure: Lumbar Disability
timeFrame: 2 weeks
measure: Step length
timeFrame: 2 weeks
measure: Stride length
timeFrame: 2 weeks
measure: Gait velocity
timeFrame: 2 weeks
measure: Disc Height
timeFrame: 2 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Islamabad
country: Pakistan
facility: Foundation University Islamabad
Study officials:
affiliation: FUI
name: Muhammad Osama, PhD*
role: PRINCIPAL_INVESTIGATOR
affiliation: FUI
name: Aamer Naeem, PhD*
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00178594: Evaluation of Hemostasis in Bleeding and Thrombotic Disorders
Official title: Evaluation of Hemostasis in Bleeding and Thrombotic Disorders Using the Roteg Analyzer and the Thrombin Generation Assay
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Blood Coagulation Disorders, Inherited
Thrombotic Disorder
Keywords: Hereditary Bleeding disorder
Thrombotic Disorder
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
First posted: 2005-09-15
Enrollment: 1000
Sex: ALL
Minimum age (years): 1
Maximum age (years): 98
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Subjects with an acquired or congenital bleeding disorder or acquired thrombotic disorder receiving treatment for their condition at UTHealth Houston.

Brief summary: The objective of this study will be to assess the coagulation system in-vitro in a variety of bleeding and clotting disorders using the ROTEG analyzer and the thrombin generation assay.

Detailed description: This is an exploratory study involving blood coagulation assays in a select group of individuals receiving treatment for their congenital or acquired bleeding or clotting disorder at UTHealth Houston. The ROTEG is a newly developed coagulation analyzer which allows the continuous assessment of whole blood coagulation from the formation of the first fibrin fibers and activated platelets, to the formation of a three-dimensional whole blood clot until the eventual dissolution of the clot. This device will not be used as a diagnostic or procedure tool. No recommendations regarding interpretation of the results or implications for future treatment will be provided.

Eligibility criteria: Inclusion Criteria: patients with congenital or acquired bleeding or clotting disorders who have provided informed consent and/or assent

Exclusion Criteria: poor venous access

Primary outcomes:
measure: Assess primary and secondary hemostasis in individuals with bleeding and clotting disorders
timeFrame: 24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: The Univerisity of Texas Health Science Center at Houston
state: Texas
city: Houston
country: United States
facility: UT Physicians Women's Center-Texas Medical Center
state: Texas
Study officials:
affiliation: The University of Texas Health Science Center, Houston
name: Miguel Escobar, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00224094: A Comparison of Patch vs. Pill Estrogen Therapy on Testosterone Levels and Thyroid Tests in Menopausal Women
Official title: A Comparison of Transdermal vs. Oral Estrogen Replacement Therapy on Androgen Levels and Thyroid Function in Naturally Menopausal Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Menopause
Keywords: Menopause
Testosterone
Androgens
Sex Hormone Binding Globulin
Thyroid function
Cortisol
Lead sponsor: Watson Pharmaceuticals
Sponsor class: INDUSTRY
Collaborators: name: Massachusetts General Hospital
First posted: 2005-09-22
Enrollment: 27
Sex: FEMALE
Minimum age (years): 42
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This study compares the effects of 12 weeks of treatment with transdermal versus oral estrogen therapy on testsoterone levels and thyroid tests in healthy, naturally menopausal women.


Eligibility criteria: Inclusion Criteria:

* Healthy
* Naturally menopausal women
* Aged 42-70 years
* Currently using combination estrogen-progestin replacement therapy

Exclusion Criteria:

* Women with contraindications to HRT use, including:Unexplained vaginal bleeding, liver disease, breast or endometrial cancer, venous thromboembolic events
* Thyroid disease
* Adrenal disease

Primary outcomes:
measure: Compare the effects of a 12-week course of oral CEE to a 12-week course of transdermal estradiol on free testosterone concentrations in menopausal women.
timeFrame: 12 weeks
Secondary outcomes:
measure: Compare the effects of oral versus transdermal ERT on thyroid binding globulin concentrations and tests of thyroid function.
timeFrame: 12 weeks
measure: Compare the effects of oral versus transdermal ERT on cortisol binding globulin and total and free cortisol concentrations.
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Jan L Shifren, MD
role: PRINCIPAL_INVESTIGATOR
References: