louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00987038: A Midazolam Drug Interaction Study With PF-04171327
Official title: A Phase 1, Open Label, Multiple Dose Study Of The Effect Of PF-04171327 On Midazolam Pharmacokinetics In Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Keywords: drug interaction CYP3A4 glucocorticoids midazolam
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2009-09-30
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to investigate the effects of multiple doses of PF-04171327 on the blood levels (pharmacokinetics) of midazolam


Eligibility criteria: Inclusion Criteria:

* Healthy males and/or females (non-childbearing potential) volunteers.
* Cortisol level within normal reference range of the laboratory.

Exclusion Criteria:

* History of intolerance or significant adverse effect with glucocorticoid (steroid) therapy.
* History or current positive results for HIV, Hepatitis B or C or active TB or currently undergoing treatment for TB.
* Known history of hypersensitivity, allergy severe drug reaction or unable to tolerate midazolam or other benzodiazepines.

Primary outcomes:
measure: AUCinf of midazolam
timeFrame: 17 days
Secondary outcomes:
measure: AUClast, Cmax, Tmax, t1/2
timeFrame: 17 days
measure: Vital Signs, Clinical Laboratory tests and Adverse Events
timeFrame: 28 days
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Pfizer Investigational Site
state: Connecticut
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: Ripp SL, Mukherjee A, Eng H, Stock T, Fleishaker D, Checchio T, Tammara B. In Vitro and In Vivo Investigation of Potential for Complex CYP3A Interaction for PF-00251802 (Dagrocorat), a Novel Dissociated Agonist of the Glucocorticoid Receptor. Clin Pharmacol Drug Dev. 2018 Mar;7(3):244-255. doi: 10.1002/cpdd.411. Epub 2017 Nov 7.
Clinical trial NCT01926938: Endothelial Function in Young Hispanic Adults at Risk for Type 2 Diabetes
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Obesity
Insulin Resistance
Lead sponsor: Joslin Diabetes Center
Sponsor class: OTHER
First posted: 2013-08-21
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Young Latino adults with and without family history of type 2 diabetes

Brief summary: Diabetes is a major public health problem. Hispanics/Latinos are known to be at higher risk for type 2 diabetes. The function of the endothelium has played a key role in the understanding of vascular complications in people with diabetes. Endothelial function and vascular reactivity are impaired not only in white adults with type 2 diabetes but also in those at risk for the disease by virtue of having impaired glucose tolerance or parental history of type 2 diabetes. Whether this finding is applicable to hispanics is not known. The investigators plan to assess the endothelial function and vascular reactivity in young Hispanic adults at risk of developing type 2 diabetes by virtue of being obese and belonging to a minority population.


Eligibility criteria: Inclusion Criteria:

* Group 1:

  1. Age between 18-40 years;
  2. Hispanic (we will consider a subject being Hispanic if both parents are reported as Hispanics when asked the following question: "What ethnic group do you consider that you belong to?");
  3. History of type 2 diabetes in one or both parents;
  4. BMI above 27;
  5. Not have participated in any exercise program for the 6 months prior to the beginning of the study.

Group 2:

1. Age between 18-40 years;
2. Hispanic (same criteria as above );
3. No history of type 2 diabetes in any first degree relative;
4. BMI under 25;
5. Not have participated in any exercise program for the 6 months prior to the beginning of the study.

Exclusion Criteria:

* diabetes, glucose intolerance, pregnancy, smoking, cardiovascular disease, uncontrolled hypertension, renal disease, proteinuria, cancer, infectious diseases, severe GI diseases, lung disease, electrolyte abnormalities, anemia, endocrine disorders, severe dyslipidemia, peripheral vascular disease, medications: beta-blockers, any diuretic, calcium channel blockers, ACE inhibitors, angiotensin receptor blockers, niacin, glucocorticoids, any antineoplastic agent, antibiotics, psychoactive agents, bronchodilators or insulin.

Primary outcomes:
measure: markers of endothelial activation, coagulation and inflammation
timeFrame: cross sectional evaluation
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Joslin Diabetes Center
state: Massachusetts
Study officials:
affiliation: Joslin Diabetes Center
name: Enrique Caballero, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03415438: Assessment of Thoracolumbar Fascia Length
Official title: Assessment of Thoracolumbar Fascia Length in Patients With Subacromial Impingement Syndrome
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Fascia
Keywords: thoracolumbar fascia
subacromial impingement syndrome
Lead sponsor: Baskent University
Sponsor class: OTHER
First posted: 2018-01-30
Enrollment: 60
Sex: ALL
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 30 patients with Subacromial Impingement Syndrome and 30 volunteers

Brief summary: The purpose of the study is to compare the elasticity of thoracolumbar fascia in patients with and without subacromial impingement syndrome.

30 patients diagnosed as subacromial impingement syndrome in physical medicine and rehabilitation department of Baskent University will be recruited as group 1. 30 healthy volunteers will be recruited as group 2. Visual Analogue Scale (VAS) with the aim of assessing pain severity, tape measurement for posterior capsule shortness; body lateral flexion, rotation and extensor movements and lumbar extensor shortness will be observed for correlation with thoracalumbal fascia flexibility. Lateral flexion, flexion, and extension movements will be measured using goniometry for trunk normal joint movements. The thoracolumbar fascia length test and Modify Schober test will be used for thoracolumbar fascia length.


Eligibility criteria: Inclusion Criteria:

* 30 patients with Subacromial Impingement Syndrome and 30 volunteers
* between ages of 20-40 years
* both sexes

Exclusion Criteria:

* having lumbar surgery
* having problem with lumbar region in last 6 months
* having scoliosis
* radiologically diagnosed kiphosis
* MR diagnosed lumbar and thoracic herniation
* positive sacroiliac tests
* restricted pelvic motion
* having scapular dyskinesia

Primary outcomes:
measure: thoracolumbar fascia length test
timeFrame: 1 week
Secondary outcomes:
measure: Visual Analogue Scale measurement in cm with 0 pointing no pain and 10 pointing worst pain. patient marks the intensity of his/her pain in a 10 cm line and researcher measures the intensity of the pain with a tape.
timeFrame: 1 week
measure: Goniometric measurement
timeFrame: 1 week
measure: Shortness measurement with tape measurement in cm. patient stretches the posterior capsule and the beginning and the end positions are measured with tape.
timeFrame: 1 week
measure: lumbar extensor shortness test measurement in cm
timeFrame: 1 week
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Baskent University
Study officials:
References:
Clinical trial NCT01129908: Saliva Composition and Oral Hygiene in Children With Celiac Disease Before and After the Change in Diet
Official title: Saliva Composition and Oral Hygiene in Children With Celiac Disease Before and After the Change in Diet
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Celiac Disease
Keywords: oral health in children with celiac disease
Lead sponsor: Hadassah Medical Organization
Sponsor class: OTHER
First posted: 2010-05-25
Enrollment: 90
Sex: ALL
Minimum age (years): 3
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: chilren with celiac disease

Brief summary: The celiac disease (CD) is a disease with an immune and genetic component that is activated by the presence of gluten, and damages the intestine mucosa and causes malabsorption of food.

In the oral environment the investigators see enamel defects and recurrent ulcers.

Celiac patients have to keep a restrict gluten-free diet, in order to prevent the clinical symptoms of the disease (such as diarrhea, stomach ache and weight loss).

It has been assumed that the patients have less cariogenic diet, and that caries prevalence is not as high as in normal population.

In celiac patients the investigators find enamel defects that are characterized with pits and deep fissures and sometimes the complete loss of enamel. These defects are classified by the grading of the CD related DED's (dental enamel defects) according to Aine. These defects are symmetrical defects in the permanent dentition, in teeth that develops at the same time. The cause is thought to be hypocalcaemia or genetic.

These defects were found in 42.2% of celiac patients in appose to only 5.4% in healthy population.

Recurrent ulcers were found in 41% in the oral cavity of celiac patients, compare to 27% in healthy population.

After changing the diet to a gluten-free diet, an improvement is seen in the presence of these ulcers.


Eligibility criteria: Inclusion Criteria:

* celiac disease

Exclusion Criteria:

* no other systemic condition
* age 3-18
* children on medication

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05227508: The Effect of BRIZO on Lower Urinary Tract Symptoms (LUTS) Related to Benign Prostatic Hypertrophy (BPH)
Official title: A Double-blind, Placebo Controlled, 12-week Treatment Trial in Men With Signs and Symptoms of Benign Prostatic Hyperplasia
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: BPH Without Urinary Obstruction and Other Lower Urinary Tract Symptoms (LUTS)
Lead sponsor: Se-cure Pharmaceuticals Ltd.
Sponsor class: INDUSTRY
Collaborators: name: Clalit Health Services
First posted: 2022-02-07
Enrollment: 120
Sex: MALE
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: * Study arm- min. 80 patients
* Placebo arm- min. 40 patients
Primary purpose: TREATMENT

Brief summary: A randomized, placebo controlled double-blind, 12-week treatment trial in men with moderate to severe symptoms of benign prostatic hyperplasia. The trail is about to examine the effect of Brizo® on reduction of BPH related symptoms.

Detailed description: 1. Males in good general health 50 years of age and older, with symptoms of moderate to severe benign prostatic hyperplasia.
2. 120 patients: Study arm- min. 80 patients Placebo arm- min. 40 patients Final Aim for Stat. Sig.: 75% of recruitment group (90 patients)
3. Duration - 12 weeks with 3 visits: 0,6,12 weeks
4. The following procedures are utilized:

   * Physical exams - visit 1,3.
   * Drugs/food supplement usage questionnaire - visit 1.
   * Product supply Control - visit 1,2.3
   * Clinical laboratory tests : psa, cbc, bun - visit 1,3.
   * Uroflowmetry test visit - visit 1,3.
   * IPSS- International Prostate Symptom Score - questionnaire - visit 1, 3.
   * IIEF questionnaire - visit 1, 3.
5. dosage: 1 capsule twice daily (morning \& evening) can be taken with or without food

Eligibility criteria: Inclusion Criteria:

Males in good general health at least 50 years of age, with symptoms of moderate to severe benign prostatic hyperplasia

Exclusion Criteria:

* Inability to complete the questionnaire.
* Patients with or suspected of having prostate cancer.
* Patients who have undergone a surgical procedure in the past year and / or who have taken medications or supplements in the past six months to treat BPH.
* Patients treated with drugs for kidney / urinary tract problems.
* Allergy to soy.

Primary outcomes:
measure: Improved index in the IPSS test
timeFrame: 12 weeks
Secondary outcomes:
measure: Improve UROFLOWMETRY test
timeFrame: 12 WEEKS
Other outcomes:
Locations:
city: Petach Tikva
country: Israel
facility: Rabin Medical Center - Clalit Health Services
Study officials:
affiliation: Rabin Medical Center
name: Ohad Shoshani, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05730608: 18F-FDG PET/CT Imaging for Breast Cancer
Official title: Improving Breast Cancer Staging With 18F-FDG PET/CT Imaging (The IMBRECAS PET Study)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Breast Cancer Female
Breast Cancer Recurrent
Lead sponsor: Vestre Viken Hospital Trust
Sponsor class: OTHER
First posted: 2023-02-16
Enrollment: 300
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: Purpose To investigate the ability of 18F-FDG PET/CT imaging to detect metastases not detected by conventional imaging (CT and bone scintigraphy) in patients diagnosed with stage II/III and locoregional recurrent breast cancer (BC) which can affect the choice of treatment.

Hypothesis The hypothesis is that 18F-FDG PET/CT can provide information about disease stage beyond the currently used conventional imaging (CT and bone scintigraphy) in patients diagnosed with stage II/III or locoregional recurrent BC.

Objectives

Primary:

To evaluate if a 18F-FDG PET/CT scan in the initial work up of patients diagnosed with stage II/III or locoregional recurrent BC will lead to change in staging and/or treatment.

Secondary:

* Overall survival (OS) and progression-free survival (PFS) in the patients with upstaging based on findings on 18F-FDG PET/CT scan compared with the patients with unchanged stage of disease following 18F-FDG PET/CT.
* Obtain size of the primary BC from CT/MRI scan and evaluate if these metrics are correlated to outcome.
* Obtain PET parameters from the primary BC: maximum, mean, and peak standardized uptake value (SUVmax, SUVmean, SUVpeak), metabolic tumour volume (MTV), total lesion glycolysis (TLG), total MTV and total TLG and evaluate if these metrics are correlated with outcome.
* Obtain CT and PET texture parameters from the primary BC and evaluate if these metrics are correlated with outcome.
* Blood and tumor samples for molecular characterisation:


Eligibility criteria: Inclusion Criteria:

* Patients with high risk primary or recurrent breast cancer
* Non pregnant women \> 18 years
* Not receiving active treatment of other cancer types.
* Eastern Cooperative Oncology Group (ECOG) status 0-2.

Exclusion Criteria:

* Pregnant woman
* Males
* Age under 18
* Patients receiving active treatment for other cancers
* Poor general conditipon (ECOG 3 or higher)

Primary outcomes:
measure: Change in staging and/or management due to added 18F-FDG PET/CT scan
timeFrame: 5 years
Secondary outcomes:
measure: Overall survival
timeFrame: 5 years
Other outcomes:
Locations:
city: Drammen
country: Norway
facility: Drammen Hospital - Vestre Viken HF
Study officials:
affiliation: Vestre Viken Hospital Trust
name: Harald Grut, MD, PHD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03349008: Magnesium Isoglycyrrhizinate Followed by Diammonium Glycyrrhizinate and Combined With Entecavir in Chronic Hepatitis B
Official title: The Efficacy and Safety Study of Magnesium Isoglycyrrhizinate Injection Followed by Diammonium Glycyrrhizinate Enteric-coated Capsules and Combined With Entecavir on the Treatment of Chronic Hepatitis B
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Chronic Hepatitis b
Liver Inflammation
Keywords: necro-inflammatory
glycyrrhizin
entecavir
hepatic biological parameters
liver fibrosis
Lead sponsor: Cttq
Sponsor class: INDUSTRY
First posted: 2017-11-21
Enrollment: 480
Sex: ALL
Minimum age (years): 18
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 evaluates the addition of glycyrrhizin to entecavir in the treatment of patients with chronic hepatitis B in China. Half of participants will receive magnesium isoglycyrrhizinate followed by oral diammonium glycyrrhizinate and entecavir in combination, while the other half will receive a placebo and entecavir.

Detailed description: Chronic hepatitis B(HBV) has a high prevalence (\>8%) in China. Entecavir, aguanosine analog, is a potent and selective inhibitor of HBV DNA polymerase.

Glycyrrhizin has been used for more than 30 years in the treatment of liver diseases in Asian countries, who can relieve necro-inflammatory and liver fibrosis or cirrhosis Recent study has shown that inflammation plays the important role in chronic HBV and fibrosis or cirrhosis disease progression, but antiviral therapy only may not reduce inflammation ideally. The addition of glycyrrhizin to entecavir in the treatment may slow disease progression in patients with chronic HBV and advanced fibrosis or cirrhosis.

Eligibility criteria: Inclusion Criteria:

* Hepatitis B surface antigen \[HBsAg\]-positive,
* Either hepatitis B e antigen (HBeAg)-positive or HBeAgnegative/hepatitis B e antibody (HBeAb)-positive disease were eligible,
* Serum alanine aminotransferase (ALT) levels 3-10×the upper limit of normal (ULN),serum total bilirubin(TBIL)levels\<2×ULN

Exclusion Criteria:

* Co-infection with hepatitis C virus, hepatitis D virus, or human immunodeficiency virus;
* Other forms of liver disease;
* More than 24 weeks of therapy with a nucleoside or nucleotide analog with activity against HBV, and therapy with any anti-HBV drug within 24 weeks prior to randomization;
* More than 12 weeks of therapy with liver protectants, and therapy with glycyrrhizin;
* Has decompensated liver function or has a hint of hepatocellular carcinoma (HCC);
* During the study patients were not allowed to use other medicines.

Primary outcomes:
measure: Change of ALT(Alanine aminotransferase)
timeFrame: baseline and 24 weeks
Secondary outcomes:
measure: Change of Liver inflammatory
timeFrame: baseline and 24 weeks
measure: Change of Liver Fibrosis
timeFrame: baseline and 96 weeks
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01768208: Metabolomic Variations in the Saxagliptin-Treated Type 2 Diabetes Mellitus Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Type 2 Diabetes
Lead sponsor: Shanghai Jiao Tong University School of Medicine
Sponsor class: OTHER
First posted: 2013-01-15
Enrollment: 569
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP

Brief summary: This study is an open-label, cohort study to evaluate the potential mechanisms of Saxagliptin in the treatment of patients with type 2 diabetes (T2DM) using a comprehensive metabolomic method, in combination with fingerprint analysis and target analysis. It is a sub-study of STUDY: D168L00008.


Eligibility criteria: Inclusion Criteria:

* All the subject Inclusion Criteria should be referred to STUDY: D168L00008.

Briefly

1. Provision of informed consent prior to any study specific procedures
2. Diagnosed with type 2 diabetes
3. Men or women who are 18 years of age.
4. Patients should be drug naïve or treated with metformin alone on stable doses of for at least continues 8 weeks.
5. HbA1c are between 7.5% and 11.0%

Exclusion Criteria:

* All the subject Exclusion Criteria should be referred to STUDY: D168L00008.

Briefly

1. Pregnant or breastfeeding patients.
2. Insulin therapy within one year of enrolment(with the exception of insulin therapy during a hospitalization or use in gestational diabetes).
3. Previous treatment with any dipeptidyl peptidase-IV (DPP-IV) inhibitors or Glucagon-like peptide-1 (GLP-1) analogue.
4. History of administration of any antihyperglycemic therapy (other than metformin) during the 8 weeks prior to Visit 1(12 weeks for previous TZD).
5. Treatment with systemic glucocorticoids other than replacement therapy. Inhaled,local injected and topical use of glucocorticoids is allowed.
6. Treatment with strong cytochrome P450 inhibitors.
7. Gastrointestinal surgery that could impact the absorption of study drug.
8. Contraindications to therapy as outlined in the saxagliptin package insert.
9. Hypersensitivity to saxagliptin
10. Have a history of, or currently have, acute or chronic pancreatitis.
11. Type 1 diabetes, history of diabetic ketoacidosis or hyperosmolar non-ketonic coma.
12. Any condition where, in the opinion of the investigator, participation in this study may pose a significant risk to the patient or could render the patient unable to successfully complete the study.
13. Fasting plasma glucose \>15mmol/l.

Primary outcomes:
measure: The primary objective of the study is to evaluate the changes in the metabolomic parameters before and after Saxagliptin treatment in type 2 diabetic patients.
timeFrame: 24 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Jiao Tong University School of Medicine
state: Shanghai
Study officials:
References: