louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02432313: Safety, Tolerability, and Pharmacokinetics of Modified and Immediate Release Anatabine Citrate Formulations
Official title: 3-Part Study With 2 6-Period Single Dose Parts (Pt 1, Pt 2 Optional) Followed by a 1-Period Multiple Dose Part (Pt 3) to Evaluate Prototype Modified Release Matrix and Multi Particulate Formulations of Anatabine Citrate to Determine PK
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Pharmacokinetics of Anatabine
Lead sponsor: Rock Creek Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
First posted: 2015-05-04
Enrollment: 37
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: Parts 1 and 2:

Subjects take 1 dose of various formulations of the study product, and provide samples for pharmacokinetic (PK) analysis after each, with at least 7 days between doses.

Part 3:

Subjects take 2-4 doses of study product or placebo for 6 days, plus 1 additional dose, and provides samples for PK analysis.

Detailed description: Parts 1 and 2:

Subjects will be admitted to the clinic on the day before dosing (Day -1). Subjects will fast overnight and receive the study product in the morning of Day 1 in a non-randomized manner. Subjects will remain onsite until 24 h post-dose and will return to the clinical unit at 36 and 48 h post-dose to provide a sample for PK analysis.

There will be at least a 7-day washout between regimens. Subject will be telephoned 3-5 days after the final dose to ensure his/her ongoing well-being.

Part 3:

Subjects will be admitted to the clinic on the day before dosing (Day -1). Subjects will fast overnight (for Day 1 and Day 7) and receive the study product or placebo on a once, twice, or three times a day regimen in a randomized, double-blind manner. Subjects will remain onsite until 24 h after the final dose (Day 7), leaving the clinic on the morning of Day 8 and returning at 36 and 48 h post last-dose to provide a sample for PK analysis.

Subject will be telephoned 3-5 days after the final dose to ensure his/her ongoing well-being.

Eligibility criteria: Inclusion Criteria:

* negative for urinary cotinine
* normal test values for liver function
* provide informed consent

Exclusion Criteria:

* clinically significant abnormal biochemistry, hematology, or urinalysis, as judged by the investigator

Primary outcomes:
measure: PK measures of blood anatabine
timeFrame: 0-2 hrs (every 15 min); 2-6 hrs (every 30 min); 6-12 hr (every 60 min); at 18, 24, 36, and 48 hr
Secondary outcomes:
measure: reported adverse events or serious adverse events
timeFrame: immediately post-dose to 5-days post-dose
Other outcomes:
measure: measures of pro-inflammatory mediators from stimulated peripheral blood mono-nuclear cells
timeFrame: pre-dose to 12 hours post-dose
Locations:
city: Nottingham
country: United Kingdom
facility: Quotient Clinical
Study officials:
affiliation: Quotient Clinical
name: Sharan Sidhu, MBChB, MRCS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00319813: General Practice Quality Assurance Project. Chronic Obstructive Pulmonary Disease (COPD) Diagnosis and Treatment
Official title: General Practice Quality Assurance Project. COPD Diagnosis and Treatment
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pulmonary Disease, Chronic Obstructive
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2006-04-27
Enrollment: 8000
Sex: ALL
Minimum age (years): 35
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no

Brief summary: A Cross sectional observational Quality Assurance Project in General Practice to COPD Diagnosis and Treatment


Eligibility criteria: Inclusion Criteria:

* COPD patients over 35 years of age
* More than two annual renewals with the following group of inhalation preparations: Anticholinergic, beta-2 antagonists, steroids or a combination of these

Exclusion Criteria:

* Asthma

Primary outcomes:
measure: To optimise the diagnosis and treatment of COPD via a quality assurance project
timeFrame: Up to 1.2 years
measure: Increase the knowledge and use of diagnostic tools and treatment amongst PCPs
timeFrame: Up to 1.2 years
measure: To focus on implementation of national guidelines for diagnosis and treatment of COPD
timeFrame: Up to 1.2 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: B.I. Denmark A/S
name: Boehringer Ingelheim Study Coordinator
role: STUDY_CHAIR
References:
Clinical trial NCT05193513: Tow Maxillary Hybrid Expanders Screw Supported Versus Lateral Angulated One; a Prospective Randomized Clinical Study
Official title: Comparison of Tow Maxillary Hybrid Expanders -Perpendicular Screw Supported Versus Lateral Angulated One; a Prospective Randomized Clinical Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cross Bite
Lead sponsor: Al-Azhar University
Sponsor class: OTHER
First posted: 2022-01-18
Enrollment: 20
Sex: ALL
Minimum age (years): 12
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: in this study i will use to different designs of t maxillary hybrid expanders that consists of HYREX supported with tow miniscrews to treat the collapsed maxilla in Yonge adolescents

Detailed description: the maxilla is expanded by tow diffrent designs of maxillary hybrid expanders

Eligibility criteria: Inclusion Criteria:

1. Medically free male or female patients
2. Patients that necessitated maxillary expansion due to constricted maxillary arch shown by a unilateral or bilateral posterior crossbite.
3. The patient should have no missing teeth except third molars.
4. Age ranged from 12 to 18 years old.
5. The patient should have a good gingival condition.
6. The patient should have a good periodontal condition.

Exclusion Criteria:

1-hisory of previous orthodontic treatment. 2- Lack of cooperation. 3- Mental problems. 4- Skeletal open bite. 5- TMJ problem.

-

Primary outcomes:
measure: change in maxillary width
timeFrame: 12 weeks following end of treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Al azhar university
Study officials:
References:
Clinical trial NCT03954613: Evaluation of the Contribution of Regular Cognitive Exercises to Treatment in Patients With Alzheimer's Disease
Official title: Evaluation of the Contribution of Regular Cognitive Exercises to Treatment in Patients With Alzheimer's Disease Receiving Donepezil, Memantine or Donepezil/Memantine Combination Therapy: Open-Labeled, Randomized, Phase IV, Superiority Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Alzheimer Disease
Cognitive Change
Keywords: Alzheimer Disease
Cognitive Exercises
Internet
Donepezil
Memantin
Combination
Lead sponsor: Neutec Ar-Ge San ve Tic A.Ş
Sponsor class: INDUSTRY
First posted: 2019-05-17
Enrollment: 198
Sex: ALL
Minimum age (years): 55
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: In this study, it is aimed to compare the effects of cognitive exercises applied on long-term internet environment to the cognitive level of patients who received donepezil, memantine or donepezil / memantin combination therapy.


Eligibility criteria: Inclusion Criteria:

* Patients between 55-90 years old who were diagnosed with Alzheimer's Dementia and had no history of cerebrovascular disease during the last 6 months,
* Patients without other neurodegenerative diseases and secondary dementia diagnoses,
* Patients with MOCA score of between 13-18,
* Patients with at least primary school graduation,
* Patients who have had no CNS disease including trauma in the last year,
* Patients without a diagnosis of psychiatric disease,
* Patients with a tablet or PC with an internet connection,
* Patients agreeing to perform BEYNEX daily activity at least 5 times per week,
* Patients signing informed consent form.

Exclusion Criteria:

* Patients who have hypersensitivity to study working drugs,
* Psychotic patients,
* Disabled patients with orthopedic dominant extremity,
* Patients with ICU follow-up due to trauma in the last 6 months,
* Patients with severe visual impairment or eye surgery,
* Patients who refuse to sign the informed consent form.

Primary outcomes:
measure: Change in MOCA total score
timeFrame: 6-months
Secondary outcomes:
measure: Change in GDS total score
timeFrame: 6-months
measure: Change in ADAS-Cog total score
timeFrame: 6-months
measure: Change in CDR total score
timeFrame: 6-months
measure: Change in B-ADL total score
timeFrame: 6-months
measure: Change in clock drawing test
timeFrame: 6-months
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Maltepe University Hospital
Study officials:
affiliation: Project Consultant
name: Türker Şahiner, Prof Dr
role: STUDY_CHAIR
References:
Clinical trial NCT04686513: Relative Risk of Hypertension Among Obese
Official title: Relative Risk of Hypertension Among Young Adult Obese Population
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Obesity
Lead sponsor: Ziauddin University
Sponsor class: OTHER
First posted: 2020-12-28
Enrollment: 1149
Sex: ALL
Minimum age (years): 25
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Obese young adult population of BMI \<25kg/m2

Brief summary: Observational study was conducted to determine the relative risk of hypertension among young adult obese population of Pakistan with age between 25-40 years


Eligibility criteria: Inclusion Criteria:

Adult population with age between 25- 40 years having normal weight or Obesity of grade I and II, with or without hypertension.

Exclusion Criteria:

Patients with co-morbid like Diabetes mellitus, dyslipidemia, and cardiovascular disorder were excluded from the study

Primary outcomes:
measure: Hypertension
timeFrame: day 1
Secondary outcomes:
Other outcomes:
Locations:
city: Karachi
country: Pakistan
facility: Batool Hassan
state: Sindh
Study officials:
References:
Clinical trial NCT00477113: TYSABRI Global Observational Program in Safety
Official title: TYGRIS: TYSABRI® Global Observational Program in Safety
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Multiple Sclerosis
Keywords: natalizumab
MS
Tysabri
Multiple Sclerosis
TYGRIS
Lead sponsor: Biogen
Sponsor class: INDUSTRY
First posted: 2007-05-22
Enrollment: 2207
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: MS patients treated with TYSABRI in North America

Brief summary: The Primary objective of this study is to determine the incidence and pattern of serious infections, malignancies, and other serious adverse events (SAE) in participants with multiple sclerosis (MS) treated with Tysabri (natalizumab).

Detailed description: The TYSABRI Global Observational Program in Safety (TYGRIS) is a safety observational cohort program designed to obtain long-term safety data in multiple sclerosis (MS) participants treated with natalizumab in a clinical practice setting in the United States or Canada.

Eligibility criteria: Key Inclusion Criteria:

* MS patients in the US and Canada receiving TYSABRI under standard clinical care for less than or equal to 3 infusions are eligible to participate in TYGRIS.

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

Primary outcomes:
measure: Number of participants with serious infections, malignancies, and other SAEs
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Kansas City
country: United States
facility: There may be mulitple sites in this clinical trial. Contact United BioSource Corporation
state: Missouri
Study officials:
affiliation: Biogen
name: Medical Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT00245713: Determine Effects of Adjunctive Levetiracetam on Sleep Architecture in Adults With Partial Onset Epilepsy.
Official title: 9-11 Week Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel Study to Determine Effects of Adjunctive Levetiracetam on Sleep Architecture of Adults With Partial Onset Epilepsy Receiving a First Generation Anti-epileptic Drug.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Epilepsy, Partial
Keywords: Levetiracetam, adult, partial-onset epilepsy, antiepileptic
Lead sponsor: UCB Pharma
Sponsor class: INDUSTRY
First posted: 2005-10-28
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: Effect of adjunctive levetiracetam on polysomnography in adults with partial-onset epilepsy receiving a classical antiepileptic drug


Eligibility criteria: Inclusion Criteria:

* Subjects must have partial onset epilepsy and have been taking carbamazepine or phenytoin at a stable dose for a period of 4 weeks prior to the selection visit
* Subjects must have controlled partial onset seizures which can potentially benefit from adjunctive treatment

Exclusion Criteria:

* Subjects dosing with LEV two weeks prior to the selection visit
* Subjects using more than one AED
* Subjects with specific and non-specific sleep disorders

Primary outcomes:
measure: Changes from Baseline to visit 7 in percent REM, percent slow wave sleep (stages 3 and 4), and sleep efficiency (which is total sleep time ÷ time in bed defined as lights out), with particular focus on sleep efficiency.
Secondary outcomes:
measure: Secondary endpoints are based on the changes from Baseline to visit 7
Other outcomes:
Locations:
Study officials:
affiliation: UCB Pharma
name: UCB Clinical Trial Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT02718313: Echocardiographic Findings and 30-days Outcomes for Intraventricular Conduction Delay in Patients Undergoing Elective Surgeries
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: General Anesthesia
Keywords: intraventricular conduction delay
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2016-03-24
Enrollment: 100
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adults patients who are planning surgery under general anesthesia and whose preoperative electrocardiography reading is intraventricular conduction delay

Brief summary: The purpose of this study is to investigate the type of the cardiac disease using transthoracic echocardiography in patients whose preoperative electrocardiography shows the intraventricular conduction delay.


Eligibility criteria: Inclusion Criteria:

* Adult patients aged over 20 yrs who are scheduled for surgery under the general anesthesia and whose preoperative electrocardiography finding is intraventricular conduction delay.

Exclusion Criteria:

* Patients who are planning cardiac surgery
* Patients who has chest wall disease
* Pregnancy

Primary outcomes:
measure: presence of cardiac disease
timeFrame: Within 1 hour after the induction of general anesthesia
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02745613: Type 2 Diabetes Affect Exercise Induced Improvement in Insulin Sensitivity
Official title: Does a Family History of Type 2 Diabetes Affect Exercise Induced Improvement in Insulin Sensitivity in a Hispanic Population?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Insulin Sensitivity/Resistance
Lead sponsor: University of Texas, El Paso
Sponsor class: OTHER
First posted: 2016-04-20
Enrollment: 24
Sex: MALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This study investigates weather a family history of type 2 diabetes affects exercise induced improvements in insulin sensitivity in the hispanic population

Detailed description: A family history of T2D (FH+) is a risk factor for developing insulin resistance (which precedes T2D) and T2D (Ryder et al., 2003). Exercise training on the other hand has been shown to improve insulin sensitivity and is highly effective to prevent/manage T2D. However it is not known if early signs of insulin resistance appear before being clinically diagnosed and if the benefits of exercise which prevent/cure T2D, are limited to the offspring of Hispanic T2D parents. Therefore, the proposed study will determine 1) if normoglycemic (normal blood glucose) offspring of T2D parents are insulin resistant, using the gold standard method to measure insulin sensitivity and metabolic flexibility (ability to switch between carbohydrate and fat oxidation) 2) if 8 weeks of exercise training improves insulin sensitivity and metabolic flexibility to the same extent in FH+ compared to normoglycemic offspring of parents without any history of T2D (FH-) and 3) if 8 weeks of exercise training will change the blood, lipid and molecular profiles relevant to insulin sensitivity to same extent in FH+ compared to offspring of parents without family history of T2D (FH-).

Eligibility criteria: Inclusion Criteria:

* 18 ≤ Age ≤ 40 years
* 18 ≤ BMI ≤ 30 kg/m2
* Both parents are Mexican/Mexican-American)
* Sedentary lifestyle
* Less than 60 minutes/wk. of structured exercise
* Physical activity level ≤ 1.4

Exclusion Criteria:

* Evidence of significant cardiovascular disease or diabetes
* A fasting blood glucose ≥100 mg/dL
* Screening blood pressure \>140/90
* Hyperlipidemia
* Use of drugs affecting energy metabolism or body weight
* Excess alcohol, drug abuse, and smoking
* Eating disorder or eating attitudes interfering with study
* Unwillingness to be abide by randomization

Primary outcomes:
measure: Insulin sensitivity
timeFrame: 8 weeks
Secondary outcomes:
measure: Myokine concentrations
timeFrame: 8 weeks
Other outcomes:
Locations:
city: El Paso
country: United States
facility: University of Texas at El Paso
state: Texas
Study officials:
affiliation: University of Texas, El Paso
name: Sudip Bajpeyi, PhD.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04748913: Diagnostic Accuracy of Near Infrared Transillumination in Combination With a Dye in the Cavitation Detection
Official title: Diagnostic Accuracy of Near Infrared Transillumination in Combination With a Dye in the Cavitation Detection
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Initial Proximal Caries
Lead sponsor: Universidad Rey Juan Carlos
Sponsor class: OTHER
First posted: 2021-02-10
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: The aim of the study will be to make a comparison in vivo of the following techniques:

DIAGNOcam, DIAGNOcam in combination with indocyanine and bitewing radiography, analyzing the ability to detect cavitation in initial proximal caries in posterior teeth using visual separation with tactile exploration as a gold standard.

Methodology:

During a period of 2 years, patients with initial proximal caries will be evaluated in the facilities of the clinic belonging to the Fundación de la Clínica Universitaria of the Rey Juan Carlos University (Madrid, Spain). Those subjects where a minimum of a proximal carious lesion (E1, E2 or D1) is diagnosed in posterior teeth will be candidates for the study. The exploration of proximal caries will be carried out in four phases: radiographic exploration, exploration with DIAGNOcam, exploration with DIAGNOcam and Indocyanine and visual-tactile exploration with separation. Once the visual-tactile examination with separation has been completed, the caries lesions will be treated. Depending on whether the lesion is cavitated or not, a non-invasive procedure or an operative treatment will be chosen.


Eligibility criteria: Inclusion Criteria:

* E1, E2 and D1 proximal carious lesions in permanent posterior teeth (E1: outer half of enamel; E2: inner half of enamel; D1: outer half of dentin)

Exclusion Criteria:

* estructural abnormalities
* visible clinical cavitation
* restorations on the proximal surfaces
* open contact points
* overlapping structures on the X-ray that prevent a clear view of the proximal area

Primary outcomes:
measure: Near infrared transillumination
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Alcorcón
country: Spain
facility: Santiago De Vega Calleja
state: Madrid
Study officials:
References:
Clinical trial NCT06372613: Association Between LRG and Histologic Remission in Ulcerative Colitis
Official title: What is the Level of Serum Leucine-rich α 2-glycoprotein (LRG) Which Predicts Histologic Remission in Patients With Ulcerative Colitis?
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Ulcerative Colitis in Histologic Remission
Lead sponsor: Showa Inan General Hospital
Sponsor class: OTHER
First posted: 2024-04-18
Enrollment: 100
Sex: ALL
Minimum age (years): 20
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Active UC patients

Brief summary: We attempt to clarify the serum leucine-rich α 2-glycoprotein (LRG) level which can predict histologic remission in ulcerative colitis patients in this study. Colonoscopy with histology will be performed when histologic remission is predicted, irrespective of symptoms or serum LRG values. Serum LRG levels are analyzed by an enzyme-linked immunosorbent assay.

Detailed description: Aim: Serum leucine-rich α 2-glycoprotein (LRG) may be a noninvasive biomarker for monitoring disease activity in patients with ulcerative colitis (UC). We attempt to clarify the LRG level which predicts histologic remission in UC patients in this study.

Methods: Patients with UC were consecutively enrolled with the measurement of serum LRG. Colonoscopy with histology is performed when histologic remission is predicted, irrespective of symptoms or serum LRG values. Serum LRG levels are analyzed by an enzyme-linked immunosorbent assay. For the evaluation of UC activity, clinical remission was defined as score 1 or 0 using the partial Mayo score and endoscopic remission was defined as score 0 using the Mayo endoscopic subscore. And histologic remission is defined as \< grade 2 using Geboes score. We analyze the area under receiver operating characteristic (ROC) curves to evaluate the diagnostic ability of LRG for predicting histologic remission of UC.

Eligibility criteria: Inclusion Criteria:

* active UC patients

Exclusion Criteria:

* None

Primary outcomes:
measure: Histologic remission of UC
timeFrame: 1 week
Secondary outcomes:
measure: Endoscopic remission
timeFrame: 1 week
Other outcomes:
Locations:
city: Komagane
country: Japan
facility: Showa Inan General Hospital
Study officials:
References: