louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02658864: Pharmacokinetic Properties and Effect of Food on Pharmacokinetic Properties of the Oral Lafutidine Tablets
Official title: Pharmacokinetic Properties and Effect of Food on Pharmacokinetic Properties of the Oral Lafutidine Tablets in Healthy Chinese Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Chronic Gastritis
Keywords: lafutidine tablet
pharmacokinetics
food
safety
healthy subjects
Lead sponsor: Wuhan Union Hospital, China
Sponsor class: OTHER
First posted: 2016-01-20
Enrollment: 12
Sex: ALL
Minimum age (years): 19
Maximum age (years): 27
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: This study was to evaluate the pharmacokinetics of single and multiple doses of oral lafutidine tablets and the effect of food on pharmacokinetics in healthy Chinese subjects. The tolerability and the effect of sex on the pharmacokinetic properties were also evaluated to acquire more pharmacokinetic information.

Detailed description: The study of single-dose was randomized, three-period, crossover. And in this study, 12 subjects were randomly assigned to 3 dose groups and received a single dose of 10mg, 20mg and 40mg lafutidine tablets. The washout period was 7 calendar days. In the multiple-dose, 12 subjects took lafutidine tablets of 10 mg twice a day for 6 consecutive days. In the food-effect study, 12 subjects were randomly assigned to 2 groups. One group received a single dose of 10mg lafutidine tablets under fasted condition, while the other were in fed condition. The drug administrations were separated by a wash-out period of seven calendar days. In each study group, the male and the female are both in half of the subjects. Using a liquid chromatography tandem mass spectrometry (LC/MS/MS) method to determine the plasma concentration of lafutidine. Pharmacokinetic parameters were calculated using the single compartment model.

Eligibility criteria: Inclusion Criteria:

* body mass index between19 and 24 kg/m2
* negative for HIV and hepatitis B
* had no clinical important findings on health tests
* thorax radiography and ECG with no abnormalities
* normal blood pressure values
* heart rate

Exclusion Criteria:

* any drug treatment within 2 weeks before starting the study
* participation in another clinical study within the previous 3 months
* alcoholism and smoking
* pregnancy
* breast-feeding
* hypocalcemia
* blood donation or participation in other clinical trials within 3 months before enrollment in the study
* sitting blood pressure \<80/50 mm Hg or \>140/100 mm Hg
* A ventricular rate \<60 beats/min or \>100 beats/min at rest

Primary outcomes:
measure: Cmax
timeFrame: one day
measure: Area under the curve
timeFrame: one day
measure: Clearance
timeFrame: one day
measure: Apparent volume of distribution-V
timeFrame: one day
Secondary outcomes:
measure: Safety (adverse events)
timeFrame: six weeks
Other outcomes:
Locations:
Study officials:
affiliation: HUST/Union Hospital
name: Weiyong Li, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05712564: Fatigue, Depressive Disorders and Insomnia in Adult Patients with Marfan Syndrome and Ehlers-Danlos Syndrome: Survey
Official title: Observational Survey on Fatigue Levels in Relation to Depressive Disorders and Insomnia in Adult Patients with Marfan Syndrome and Hypermobile Ehlers-Danlos Syndrome
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rare Diseases
Fatigue
Insomnia
Depression
Keywords: Marfan syndrome
Ehlers-Danlos syndrome
Fatigue
Survey
Lead sponsor: IRCCS Policlinico S. Donato
Sponsor class: OTHER
Collaborators: name: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
First posted: 2023-02-03
Enrollment: 282
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Enrollment of 200 subjects with MFS and hEDS currently in follow-up at the Cardiovascular Genetic Centre, IRCCS Policlinico San Donato. The study includes the involvement of subjects with hEDS currently in follow-up at Fondazione Ca' Granda IRCCS Policliclinico.

Brief summary: The goal of this observational study is to describe and assess the presence of perceived fatigue in subjects with MFS and EDS. the main question it aims to answer through the FSS instrument is:

* The relationship of fatigue with physical and psychological characteristics, the presence of depressive disorders and insomnia.

Detailed description: Marfan syndrome (MFS) and hypermobile Ehlers-Danlos Syndrome (hEDS) are rare diseases of the connective tissue presenting peculiar symptoms as well as high mortality due to complications related to dilatation and dissection of the ascending aorta and great arteries. Life expectancy of patients with MFS and hEDS has improved markedly in the last decades, but still remains lower than that of the general population. Fatigue represent one of the main causes that limit the quality of life in these populations. The Fatigue Severity Scale (FSS) is a questionnaire widely used in populations with chronic diseases and has been previously applied in MFS and hEDS population: indeed, fatigue interferes with activities of daily living and the presence of chronic pain. However, the potential correlations that fatigue may have with different aspects of psychological well-being (i.e. insomnia and depression) were not investigated in MFS and hEDS.

Eligibility criteria: Inclusion Criteria:

* Subjects aged 18 or greater with clinical and/or genetic diagnosis of Marfan syndrome;
* Subjects aged 18 or greater with clinical and/or genetic diagnosis of hypermobile Ehlers-Danlos syndrome;
* Signed informed consent;
* Ability to speak, read and write in Italian.

Primary outcomes:
measure: Physical and psychological features
timeFrame: 10 months
Secondary outcomes:
measure: Psychosocial variables
timeFrame: 10 months
Other outcomes:
Locations:
city: San Donato Milanese
country: Italy
facility: IRCCS Policlinico San Donato
state: Lombardia
Study officials:
References:
Clinical trial NCT05543564: Prophylactic PRP in Moderate NPDR
Official title: The Case for Selective Prophylactic Pan-retinal Photocoagulation in Moderate Non-Proliferative Diabetic Retinopathy in Ophthalmic Practice in Low- Resource Settings
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Eye Diseases
Diabetes
Diabetic Retinopathy
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2022-09-16
Enrollment: 68
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with moderate NPDR at high risk

Brief summary: Diabetic retinopathy (DR) is a challenge to ophthalmic practice in communities with poor socioeconomic development. The COVID 19 pandemic has accentuated the challenge. DR is one of the leading causes of vision loss worldwide, estimated to account for 1.25% of moderate to severe visual impairment and 1.07% of blindness. Pan retinal photocoagulation (PRP) remains the gold standard treatment for preventing visual loss in PDR. Scatter photocoagulation is not recommended for eyes with mild or moderate non-proliferative diabetic retinopathy (NPDR) provided careful follow-up can be maintained,. When retinopathy is more severe, scatter photocoagulation should be considered and should not be delayed if the eye has reached the high-risk proliferative stage. As many as 27% of patients with moderate NPDR are estimated to progress to PDR in 1 year; therefore, they should be seen every 4 to 8 months. This ideal, good as it is, is not what ophthalmic practice has to deal with in communities of low-resource settings, where patients often seek medical advice due to visual complaints from the complications of PDR without being diagnosed in the non-proliferative stage or high risk PDR. Screening protocols are not followed, a situation aggravated during the COVID pandemic lockdown.


Eligibility criteria: Inclusion Criteria:

Patients with moderate NPDR at high risk which includ:

* Patients with PDR in the other eye
* Patients whose Glycosylated Haemoglobin (HbA1c) more than 8 %.
* Patients with early cataract
* Patients on regular renal dialysis or with impaired renal function
* Patients with restricted mobility because of neurological or orthopedic conditions
* Patients dependent on others, including old age.
* Women in rural areas, who are dependent on the accompaniment of a male relative.

Exclusion Criteria:

* Any patient who or whose relatives confirmed their attendance for regular follow-up according to the planned schedules after being informed of the possible complications which could happen if he or she did not attend.
* Patients with clinically significant macular edema (CSME).

Primary outcomes:
measure: BCVA
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Assiut University
Study officials:
References:
Clinical trial NCT06044064: "Effect of Screening Using Imaging (CT/ EUS) on Early Detection of Pancreatic Ductal Adenocarcinoma (PDAC) in Patients With New Onset Diabetes (NOD)" - A Prospective Pilot Observational Study
Official title: "Effect of Screening Using Imaging (CT/ EUS) on Early Detection of Pancreatic Ductal Adenocarcinoma (PDAC) in Patients With New Onset Diabetes (NOD)" - A Prospective Pilot Observational Study
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Pancreatic Ductal Adenocarcinoma (PDAC)
Lead sponsor: Asian Institute of Gastroenterology, India
Sponsor class: OTHER
First posted: 2023-09-21
Enrollment: 100
Sex: ALL
Minimum age (years): 50
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All the consecutive patients coming to OP will be screened at AIG for the study criterias, those who are meeting them, shall be enrolled after consent. Patients will enrolled for 1 year and followed up for 3 years

Brief summary: To assess whether EUS (Endoscopic Ultrasound) can serve as a valuable diagnostic tool for identifying PDAC at an early stage in individuals who have recently been diagnosed with diabetes.

Purpose: To improve the rates of early detection of pancreatic cancer.

Pancreatic ductal adenocarcinoma (PDAC) is a type of cancer that starts in the pancreas, a gland located in your abdomen. It happens when some cells in the pancreas start growing abnormally and form a cancer.


Eligibility criteria: Inclusion Criteria:

* Age \> 50 years
* Patients diagnosed with diabetes based on FBS/ PPBS/ HbA1C
* Presence of atleast 1 FBS parameter measured in the past 6-18 months which was not \> 125 mg/dl
* END-PDAC score \> 2

Exclusion Criteria:

* Known or newly detected chronic pancreatitis
* Past history of pancreatic cancer
* History of steroid use
* Contraindications for EUS

Primary outcomes:
measure: Incidence of PDAC at 3 years
timeFrame: 3yrs
Secondary outcomes:
measure: • Incidence of PDAC at baseline • Incidence of resectable PDAC at baseline • Incidence of resectable PDAC at 3 years
timeFrame: baseline and 3yrs
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03926364: Profile of Pain and Unpleasant Sensations in Patients With Referred Pain
Official title: Spatiotemporal Profile of Pain and Unpleasant Sensations in Referred Pain: a Feasibility Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Referred Pain
Somatic Pain
Neuropathic Pain
Keywords: Pain drawings
referred pain
somatic pain
neuropathic pain
e-health
pain location
biopsychosocial factors
back pain
neck pain
pain extent
function
Lead sponsor: Aalborg University
Sponsor class: OTHER
Collaborators: name: Aalborg University Hospital
First posted: 2019-04-24
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with referred pain recruited from advertisement in public areas, social media, public and collaborating private clinics and hospitals.

Brief summary: This feasibility study primarily aimed to assess the technology acceptance and usability of a pain tracking software in patients with spinally referred chronic pain. The secondary aim was to assess the fluctuations in pain intensity and distribution, using the pain tracking software during a 3-month period. Additionally, the study aimed to explore the patients' behavior when self-reporting pain when given the opportunity to use a variety of pain quality descriptors, such as tingling, burning and stabbing.

Patients with spinally referred chronic pain will be recruited to participate. Participants will be asked to use a pain tracking software to create weekly pain reports for a 3-month period. These pain reports consist of pain drawings and intensity scales. Additionally, patients will complete baseline disability and pain catastrophizing online questionnaires. The project does not affect treatment or does not offer any intervention.


Eligibility criteria: Inclusion Criteria:

* Suffer from pain in the neck or lumbar spine referring to a limb for a more than 7 consecutive days
* Participant is willing and able to give informed consent for participation in the study.

Exclusion Criteria:

* Pregnancy or breastfeeding, severe infections, cancer.
* Epilepsy, Multiple sclerosis, history of stroke, diabetes, traumatic spinal cord injury resulting in permanent functions loss
* Lack of ability to cooperate due to language barrier, cognition or inability to use technology.

Primary outcomes:
measure: Change in pain extent for 3 months
timeFrame: 3 months
Secondary outcomes:
measure: Change in pain intensity for 3 months
timeFrame: 3 months
measure: Changes in pain location for 3 months
timeFrame: 3 months
measure: Disability levels at baseline
timeFrame: Baseline
measure: Pain Catastrophizing score
timeFrame: Baseline
Other outcomes:
measure: Demographic information
timeFrame: At baseline
Locations:
city: Aalborg
country: Denmark
facility: Aalborg University Hospital
city: Aalborg
country: Denmark
facility: Aalborg University
Study officials:
affiliation: Associate Professor
name: Shellie A Boudreau, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01601964: Vascular Endothelial Growth Factor Levels in Ectopic Pregnancy
Official title: Vascular Endothelial Growth Factor Levels in Ectopic Pregnancy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Complication Following Ectopic Pregnancy
Keywords: VEGF, ectopic pregnancy.
Lead sponsor: Bagcilar Training and Research Hospital
Sponsor class: OTHER_GOV
First posted: 2012-05-18
Enrollment: 30
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 46
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The patients with ectopic pregnancy

Brief summary: The aim of this study is to determine plasma Vascular Endothelial Growth Factor level and change in patient with ectopic pregnancy who needs to surgical treatment.

Patient with ectopic pregnancy diagnosed and treated with medically or surgically will be included in the study. This is an observational study.The plasma Vascular Endothelial Growth Factor level will be measured first day and two day after the diagnosis of ectopic pregnancy.

Detailed description: This study is a prospective, observational, single-center study. Ethical approval was obtained from the Institutional Review Board. This study will be completed with 30 patients with ectopic pregnancy. An intervenous cannula will be centrifuged for 15 minutes at 1000 g within 30 minutes of collection. Aliquots of plasma will be added to eppendorf tubes and stored at -20°C.

Plasma Vascular Endothelial Growth Factor levels will be measured using a Human VEGF-A Platinum ELISA kit (bioscience company, Catalog No: 00122, Santa Clara, California, USA). All assays will be performed according to the manufacturer's instructions. The test kit sensitivity is 2.5 pg/ml. Intracycle variability is %4-6, intercycle variability is %8-10.

Eligibility criteria: Inclusion Criteria:

* Patients who suspected ectopic pregnancy

Exclusion Criteria:

* hemodynamically unstable patient
* healthy pregnancy (a healthy increase in ß HCG)
* missed abortion
* incomplete abortion
* The patient who need immediate surgical treatment

Primary outcomes:
measure: The primary Outcome Measure of this study is to determine plasma Vascular Endothelial Growth Factor cut-off level in patient with ectopic pregnancy who needs to surgical treatment.
timeFrame: 3-4 months
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Bagcilar Training and Research Hospital
Study officials:
affiliation: Bagcilar Training and Research Hospital, Istanbul, Turkey.
name: TANER A USTA, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00469521: Pilot Study Evaluation of 2 Artificial Tears. Evaluation of TBUT, Tear Meniscus Height and Tear Thickness
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Tear Film Thickness
Lead sponsor: Innovative Medical
Sponsor class: INDUSTRY
First posted: 2007-05-04
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL

Brief summary: To determine baseline tear thickness and improvement immediately post installation of two artificial tear solutions:(9582X) and Allergan Refresh Tears.


Eligibility criteria: Inclusion Criteria:

1. Normal, healthy volunteers 18 years or older
2. Males or females
3. Any race or ethnic background

Exclusion Criteria:

1. Corneal refractive surgery within 6 months of this study.
2. Contact lens use on day of examination.
3. Corneal ectasia

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Charleston
country: United States
facility: Magill Research Center Institute MUSC
state: South Carolina
Study officials:
affiliation: Magill Research Center Institute MUSC
name: Helga Sandoval, MS, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00210821: Comparing the Safety and Effectiveness of Topiramate With the Safety and Effectiveness of Amitriptyline in Preventing Migraine Headaches
Official title: A Comparison of Topiramate Versus Amitriptyline in Migraine Prophylaxis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Migraine
Headache
Keywords: migraine
headache
analgesics
prophylaxis
prevention
Lead sponsor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Sponsor class: INDUSTRY
Collaborators: name: Ortho-McNeil Neurologics, Inc.
First posted: 2005-09-21
Enrollment: 347
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to compare the effectiveness and safety of two treatment regimens in preventing migraines. The antidepressant amitriptyline has been used successfully to prevent migraine headaches.

Detailed description: People who suffer from migraines have many prescription medications to choose from, both to treat the migraine and to prevent it from starting. However, many patients have not had success in finding the drug that helps them best. Amitriptyline, an antidepressant, has been used successfully for many years to prevent migraine headaches. This study will compare the effectiveness of amitriptyline with the effectiveness of topiramate, an anti-seizure drug, in preventing migraines. The safety of both drugs will also be assessed. The objective of the study is to demonstrate that topiramate will be at least as effective as amitriptyline in preventing migraines. During the first 4 weeks of the study, topiramate or amitriptyline will be increased by 25 mg per week up to a total dose of 100 mg per day or up to the maximum tolerated dose, whichever is less. Treatment will continue at 100 mg per day for 22 weeks.

Eligibility criteria: Inclusion Criteria:

* Migraine headache for at least 6 months, with 3 to 12 headaches a month for the previous 3 months
* no more than 15 headache days in the previous month before study start
* no heart rhythm problems or neurologic problems
* women must not be pregnant and must use birth control

Exclusion Criteria:

* Cannot have failed at least 2 previous trials of migraine prevention drugs
* cannot have failed a previous trial of topiramate or amitriptyline
* no cluster headaches
* no migraine with aura without headache
* no pain that is worse than the migraine pain

Primary outcomes:
measure: Change from baseline in the average monthly migraine episode rate.
Secondary outcomes:
measure: Change in average monthly rate of days with migraine headache; change in average monthly rate of headache (migraine & non-migraine) days; change in average monthly rate of acute abortive medications; weight changes; quality of life assessments
Other outcomes:
Locations:
Study officials:
affiliation: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
name: Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial
role: STUDY_DIRECTOR
References: