louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00006432: Acute Glycemic Effects of a Very Low Fat Diet in Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus, Non-Insulin-Dependent
Lead sponsor: National Center for Research Resources (NCRR)
Sponsor class: NIH
Collaborators: name: Duke University
name: Procter and Gamble
name: Jenny Craig, Inc.
First posted: 2000-11-06
Sex: ALL
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Primary purpose: TREATMENT

Brief summary: There is some consensus that high fat diets can contribute to the development of obesity and type 2 diabetes in humans and animals. An increase in dietary fat has been shown to produce obesity and diabetes in mice; such diet-induced diabetes can be reversed by reducing the fat in the diet. In humans, there is some evidence that low-fat diets can produce acute improvements in blood sugar control in type 2 diabetes-even in the absence of weight loss. In most human studies, however, dietary fat reduction has been accompanied by a reduction in total calorie intake. It is thus not possible to separate the effects of these 2 metabolic changes. The purpose of this study is to gather preliminary information on the effect of a very-low-fat diet on blood metabolism in persons with type 2 diabetes. The design incorporates controlled feeding procedures, and 30 men and women with type 2 diabetes will be given all foods for 4 weeks--a 2-week diet standardization period (diet composition: 35% fat, 15% protein, 50% carbohydrate), followed by a 2-week experimental diet period. The experimental diet conditions are A) continuation of the moderately-high-fat standardization diet, or B) a very-low-fat diet composed of 10% fat, 15% protein, 75% carbohydrate. Outcomes will be measured after the standardization and the experimental periods. The primary outcome variable is fasting plasma glucose; secondary outcomes are fasting insulin, carbohydrate (meal) tolerance, insulin secretion and blood lipids. In addition, we will gather descriptive data on the potential acceptability and utility of a very-low-fat diet constructed using the fat substitute, olestra (sucrose polyester). There are no results yet.


Eligibility criteria: Inclusion Criteria:

* Type 2 diabetes, not tightly controlled at present
* Not using medication (insulin or oral) to control blood sugar
* Overweight, but generally healthy

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
Study officials:
name: Richard S. Surwit, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00272532: EMINEM: Efficacy of Muscoril In NEck Myofascial Syndromes
Official title: The Efficacy of Topical Thiocolchicoside in Cervical Myofascial Pain Syndrome: Triple-Arm, Single-Blind, Randomized, Prospective, Phase IV Clinical Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Myofascial Pain Syndromes
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2006-01-06
Enrollment: 65
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: Study objective:

* To demonstrate, in patients with myofascial pain syndrome in cervical region, the degree of efficacy of thiocolchicoside ointment administered to trigger point regions compared with the trigger point injection.


Eligibility criteria: Inclusion Criteria:

* Submitted to clinic with a complaint of head and neck pain
* Be diagnosed as having myofascial pain syndrome by determining the active trigger points in trapezius and/or interscapular region according to criteria of Simons and Travel
* Have 1 to 8 active trigger point(s)

Exclusion Criteria:

* Have evident cervical discopathy and signs of osteoarthritis
* Have bleeding diathesis or using anticoagulant medication which hinders injection
* Have known malignity, being used steroids, have immunodepressive disorders and/or being taken immunodepressive drugs
* Be pregnant or have the possibility of being pregnant or not being used a regular contraceptive method
* Have known allergic reaction against Thiocolchicoside

Primary outcomes:
measure: Pain relief (Visual Analog Scale and sensitometer) and increase in mobility of neck. Patient and physician satisfaction
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Sanofi-Aventis
Study officials:
affiliation: Sanofi
name: Edibe Taylan
role: STUDY_DIRECTOR
References:
Clinical trial NCT02784132: Video Diversion Improves Success Rate of Fundoscopic Examination in Children
Official title: Video Diversion Improves the Success Rate of Fundoscopic Examination in Children: a Prospective Multi-clinic, Multi-practitioner, Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fundoscopy
Lead sponsor: University of British Columbia
Sponsor class: OTHER
First posted: 2016-05-26
Enrollment: 101
Sex: ALL
Minimum age (years): 1
Maximum age (years): 4
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Primary purpose: DIAGNOSTIC

Brief summary: Fundoscopy is an important component of the neurological examination as it can detect pathologies such as high intracranial pressure. However, the exam can be challenging in uncooperative children. This study looked at whether playing a video during eye examination, improves the success, duration and ease of pediatric fundoscopy.

Detailed description: Fundoscopy is an important component of the neurological examination as it can detect pathologies such as high intracranial pressure. However, the exam can be challenging in uncooperative children. This study looked at whether playing a video during eye examination, improves the success, duration and ease of pediatric fundoscopy. The authors plan to recruit from 4 different clinical care settings for a total of 101 subjects. Success rate is defined as visualizing the optic disc within 60 seconds from commencement of fundoscopy. The ease of examination is determined by using a 10 point likert scale.

Eligibility criteria: Inclusion Criteria:

* patient aged 1 to 4 years of age (inclusive) with 2 examinable eyes

Exclusion Criteria:

* Patients who were blind, younger than 1 year of age, or older than 4 years of age

Primary outcomes:
measure: Success rate of visualizing the optic disc within 60 seconds
timeFrame: 60 second
Secondary outcomes:
measure: Time required to visualize the optic disc
timeFrame: 60 seconds
measure: Ease of performing fundoscopy
timeFrame: 60 seconds
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: BC Children's Hospital
state: British Columbia
Study officials:
affiliation: The University of British Columbia
name: Ash Singhal, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Yang MMH, Singhal A, Hengel AR, Kerr JM, St-Pierre GH, George S, Muir K, Thiessen P, Enarson P. Video Diversion Improves Success Rate of Fundoscopic Examination in Children: A Prospective Randomized Controlled Trial. Pediatr Neurol. 2018 Jun;83:32-37. doi: 10.1016/j.pediatrneurol.2017.09.008. Epub 2017 Sep 14.
Clinical trial NCT00001232: The Effect of GnRH on Pitutitary Hormones in Menstrual-Cycle Mood Related Disorders
Official title: Pituitary Gonadotropin Response to GnRH Stimulation in Menstrual, Climacteric and, Menopause-Related Mood and Behavioral Disorders
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Depressive Disorder
Healthy
Mental Disorders
Mood Disorders
Keywords: Depression
FSH
GnRH
LH
Menopause
Menstrual Cycle
Lead sponsor: National Institutes of Health Clinical Center (CC)
Sponsor class: NIH
First posted: 2002-12-10
Enrollment: 140
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes

Brief summary: The normal menstrual cycle is produced by a series of hormonal signals that starts with the release of gonadotropin-releasing hormone (GnRH) from the hypothalamus. The hypothalamus is located in the brain and is often referred to as the master gland. GnRH then acts on the pituitary gland and causes it to release two hormones, follicle stimulating hormone (FSH) and lutenizng hormone (LH). LH and FSH act on the ovary and cause it to release the hormones directly involved in menstruation, estrogen and progesterone.

The purpose of this research study is to evaluate the hypothalamic-pituitary-gonadal axis activity as measured by pituitary hormones, FSH and LH in response to intravenous doses of gonadotropin releasing hormone (GnRH) in menstrual cycle-related hormones.

Detailed description: This protocol is designed to accompany clinical protocol #81-M-0126, "The Phenomenology and Biophysiology of Menstrually Regulated Mood and Behavior Disorders", as well as the submitted protocol, "The Phenomenology and Biophysiology of Climacteric and Menopause-Related Mood and Behavioral Disorders." Its purpose will be to evaluate hypothalamic-pituitary-gonadal axis regulation as measured by pituitary gonadotropin, i.e., follicle stimulating hormone (FSH) and luteinizing hormone (LH), response to intravenous administration of gonadotropin releasing hormone (GnRH) in menstrual cycle-related mood disorders.

Eligibility criteria: Age 18-65.

Female.

Use of barrier methods of birth control.

Not pregnant.

Not taking ongoing medications.

No medical illnesses.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Bethesda
country: United States
facility: National Institute of Mental Health (NIMH)
state: Maryland
Study officials:
References:
citation: Rubinow DR, Hoban MC, Grover GN, Galloway DS, Roy-Byrne P, Andersen R, Merriam GR. Changes in plasma hormones across the menstrual cycle in patients with menstrually related mood disorder and in control subjects. Am J Obstet Gynecol. 1988 Jan;158(1):5-11. doi: 10.1016/0002-9378(88)90765-x.
citation: Schmidt PJ, Gindoff PR, Baron DA, Rubinow DR. Basal and stimulated gonadotropin levels in the perimenopause. Am J Obstet Gynecol. 1996 Sep;175(3 Pt 1):643-50. doi: 10.1053/ob.1996.v175.a74255.
citation: Fujimoto VY, Klein NA, Battaglia DE, Bremner WJ, Soules MR. The anterior pituitary response to a gonadotropin-releasing hormone challenge test in normal older reproductive-age women. Fertil Steril. 1996 Mar;65(3):539-44.
Clinical trial NCT01036932: Granulocyte Colony Stimulating Factor(G-CSF) Therapy for Patients With ACLF
Official title: To Study the Safety and Efficacy of G-CSF Therapy on the CD 34 Cell Mobilization and Outcome of Patients With ACLF
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Acute on Chronic Liver Failure
Lead sponsor: Govind Ballabh Pant Hospital
Sponsor class: OTHER_GOV
First posted: 2009-12-21
Enrollment: 50
Sex: ALL
Minimum age (years): 12
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to determine whether Granulocyte Colony Stimulating factor(G-CSF) therapy is effective in the treatment of patients with Acute on chronic liver failure(ACLF). The investigators hypothesize that ACLF is a disease where severe hepatic impairment is accompanied by impaired hepatic regeneration. BMC mobilization using G-CSF therapy, or G-CSF therapy per se would increase the regenerative capacity of the liver and shall lead to clinical, biochemical and histological improvements in patients with ACLF.


Eligibility criteria: Inclusion Criteria:

* Patients with acute hepatic insult manifesting as jaundice (Sr. Bil. ≥5 mg/dL) and coagulopathy (INR≥1.5), complicated within 4 weeks by ascites and/or encephalopathy in a patient with previously diagnosed or undiagnosed chronic liver disease.(APASL criteria)

Exclusion Criteria:

* HCC or portal vein thrombosis. Refusal to participate in the study. Sepsis ( Any culture positive: blood, urine, focus of infection on Xray chest, any other obvious source of infection: UTI, SBP) Multi organ failure. Grade 3 or 4 hepatic encephalopathy.

Primary outcomes:
measure: mobilization of CD34 cells in the peripheral blood
timeFrame: 1 month
Secondary outcomes:
measure: clinical/ biochemical improvement in liver function profile
timeFrame: 2 months
measure: frequency of multi-organ failure
timeFrame: 2 months
Other outcomes:
Locations:
city: New Delhi
country: India
facility: Shiv K Sarin
Study officials:
affiliation: G B Pant Hospital, New Delhi, India
name: Shiv K Sarin, MD, DM
role: PRINCIPAL_INVESTIGATOR
References:
citation: Garg V, Garg H, Khan A, Trehanpati N, Kumar A, Sharma BC, Sakhuja P, Sarin SK. Granulocyte colony-stimulating factor mobilizes CD34(+) cells and improves survival of patients with acute-on-chronic liver failure. Gastroenterology. 2012 Mar;142(3):505-512.e1. doi: 10.1053/j.gastro.2011.11.027. Epub 2011 Nov 23.
Clinical trial NCT05508932: Atrial Fibrillation in Beta-Thalassemia
Official title: Atrial Fibrillation in Beta-Thalassemia
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Atrial Fibrillation
Thalassemia
Keywords: Atrial Fibrillation
Thalassemia
Thalassaemia
Arrhythmia
Hemoglobinopathies
Lead sponsor: University Hospital of Ferrara
Sponsor class: OTHER
First posted: 2022-08-19
Enrollment: 350
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Transfusion-dependent Beta-thalassemia patients

Brief summary: The study aims to evaluate the clinical, laboratory and instrumental differences that exist between beta-thalassemia patients with atrial fibrillation and those not affected by arrhythmia.

Detailed description: Observational, retrospective and prospective, single-center study, which involves the collection of clinical, laboratory, electrocardiographic and imaging data of patients with major or intermediate thalassemia who have performed, from 2012 to 2022, or will perform in the next 10 years, a cardiological evaluation at the Cardiology Unit of the University Hospital of Ferrara. Patients will be divided into two groups: thalassemia patients with atrial fibrillation (paroxysmal, persistent or permanent) and thalassemia patients with no history of atrial fibrillation.

The objective of the study is to evaluate whether there is a different prevalence of the characteristics analyzed among these patient populations.

Eligibility criteria: Inclusion Criteria:

1. Transfusion-dependent Beta-thalassemia;
2. Follow-Up at the Cardiology Unit of the University Hospital of Ferrara;
3. Electrocardiogram performed;
4. Echocardiogram performed.

Exclusion Criteria:

1. Age \<18 years;
2. State Of pregnancy;
3. Inability to give informed consent.

Primary outcomes:
measure: Atrial fibrillation
timeFrame: 10 years
Secondary outcomes:
measure: Thromboembolism
timeFrame: 10 years
measure: Epicardial adipose tissue
timeFrame: Baseline
Other outcomes:
Locations:
city: Ferrara
country: Italy
facility: Matteo Bertini
Study officials:
References:
Clinical trial NCT00004332: Study of the Effect of Growth Hormone-Releasing Hormone Antagonist on Growth Hormone Release in Acromegaly
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acromegaly
Keywords: acromegaly
endocrine disorders
rare disease
Lead sponsor: Office of Rare Diseases (ORD)
Sponsor class: NIH
Collaborators: name: University of Michigan
First posted: 1999-10-19
Enrollment: 148
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes

Brief summary: OBJECTIVES: I. Determine whether release of endogenous growth hormone (GH)-releasing hormone is involved in GH responses to clonidine, pyridostigmine, levodopa, arginine, GH-releasing peptide, insulin-induced hypoglycemia, and exercise in patients with acromegaly.

II. Determine whether endogenous GH-releasing hormone influences the maintenance of GH hypersecretion.

Detailed description: PROTOCOL OUTLINE: Growth hormone-releasing hormone antagonist (GHRH-A) is administered to volunteers and followed with 1 of these challenges: insulin, clonidine, pyridostigmine, arginine, levodopa, growth hormone-releasing peptide, or exercise. Tests are repeated with normal saline as the control; the order of administration (control vs. pharmacologic stimulation) is randomly assigned.

Patients receive GHRH-A (dose determined in volunteer study), thyrotropin-releasing hormone, and growth-releasing hormone.

All stimulation tests follow an overnight fast.

Eligibility criteria: PROTOCOL ENTRY CRITERIA:

--Disease Characteristics-- Active acromegaly with growth hormone (GH) hypersecretion confirmed within 1 month prior to entry, i.e.: Somatomedin C elevated GH not below 2 ng/mL on standard 100 g oral glucose tolerance test Postmenopausal and hypogonadal women eligible Volunteers aged 18 to 30 recruited for up to 3 stimulation tests Weight within 15% of ideal Physical exam normal No history of disease No requirement for medication No medical or mental contraindication to protocol participation, including heavy alcohol or tobacco use No pregnant women --Prior/Concurrent Therapy-- Not specified --Patient Characteristics-- Age: 18 to 65 Hematopoietic: No anemia Hepatic: No hepatic disease Renal: No renal disease Cardiovascular: No uncontrolled hypertension No heart disease Other: No requirement for replacement gonadal steroids, glucocorticoids, or thyroxine No mental illness No heavy alcohol use No tobacco use No drug abuse No medical contraindication to protocol therapy

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University of Michigan
name: Ariel Barban
role: STUDY_CHAIR
References:
Clinical trial NCT00347932: A Study to Determine if 0.6% ISV-403 is Safe and Effective in the Treatment of Bacterial Conjunctivitis.
Official title: A Study to Evaluate the Clinical and Microbial Efficacy of 0.6% ISV-403 Compared to Vehicle in the Treatment of Bacterial Conjunctivitis.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Acute Bacterial Conjunctivitis
Lead sponsor: Bausch & Lomb Incorporated
Sponsor class: INDUSTRY
First posted: 2006-07-04
Enrollment: 957
Sex: ALL
Minimum age (years): 1
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Evaluation of the clinical and microbial efficacy of 0.6% ISV-403, compared to vehicle in the treatment of bacterial conjunctivitis.


Eligibility criteria: Inclusion Criteria:

* Must have a diagnosis of acute bacterial conjunctivitis and exhibit purulent conjunctival discharge and redness in at least one eye.
* Females of childbearing potential must utilized reliable contraceptive methods and have a negative pregnancy test.

Exclusion Criteria:

* Pregnant or nursing females.
* Known hypersensitivity to fluoroquinolones or to any of the study ingredients.
* Use of any antibiotic within 72 hours of treatment.
* Any disease or condition that could interfere with the safety and efficacy evaluations of the study medications.
* Participation in an ophthalmic drug or device research study within 30 days prior to entry into the study.

Primary outcomes:
measure: Clinical Resolution of Baseline Bacterial Conjunctivitis
timeFrame: Day 5 +/- 1 day
measure: Microbial Eradication of Baseline Bacterial Infection
timeFrame: Day 5 +/- 1 day
Secondary outcomes:
measure: Clinical Resolution of Baseline Bacterial Conjunctivitis
timeFrame: Day 8 or 9
measure: Microbial Eradication of Baseline Bacterial Infection
timeFrame: Day 8 or 9
Other outcomes:
Locations:
Study officials:
affiliation: Bausch & Lomb Incorporated
name: Laura Trusso
role: STUDY_DIRECTOR
References:
citation: DeCory HH, Sanfilippo CM, Proskin HM, Blondeau JM. Characterization of baseline polybacterial versus monobacterial infections in three randomized controlled bacterial conjunctivitis trials and microbial outcomes with besifloxacin ophthalmic suspension 0.6. PLoS One. 2020 Aug 25;15(8):e0237603. doi: 10.1371/journal.pone.0237603. eCollection 2020.
citation: Comstock TL, Paterno MR, Decory HH, Usner DW. Safety and tolerability of besifloxacin ophthalmic suspension 0.6% in the treatment of bacterial conjunctivitis: data from six clinical and phase I safety studies. Clin Drug Investig. 2010;30(10):675-85. doi: 10.2165/11536720-000000000-00000.
citation: Tepedino ME, Heller WH, Usner DW, Brunner LS, Morris TW, Haas W, Paterno MR, Comstock TL. Phase III efficacy and safety study of besifloxacin ophthalmic suspension 0.6% in the treatment of bacterial conjunctivitis. Curr Med Res Opin. 2009 May;25(5):1159-69. doi: 10.1185/03007990902837919.
Clinical trial NCT00305032: Effect of Endoscopic Gastric Balloon Insertion on Obstructive Sleep Apnea in Patients With Morbid Obesity
Official title: Effect of Endoscopic Gastric Balloon Insertion on Obstructive Sleep Apnea in Patients With Morbid Obesity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Morbid Obesity
Obstructive Sleep Apnea
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
First posted: 2006-03-21
Enrollment: 60
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To investigate the effect of weight loss by gastric balloon insertion on parameters of obstructive sleep apnea.

Detailed description: Most of the patients with obstructive sleep apnea (OSA) are obese. It has been noted that significant weight loss could improve the severity of sleep apnea. Significant weight loss is difficult to achieve especially in morbidly obese patients. Endoscopic gastric balloon insertion is minimally invasive procedure is employed by surgeon for weight reduction for morbidly obese patients. This study would assess the parameters of sleep which could be affected by weight reduction. If results are positive, this procedure might be considered as treatment for obstructive sleep apnea in morbidly obese patients.

Patient population would be selected from patients who would undergo gastric balloon insertion in the surgical department. There would be no sex or age limit. Patient recruited would have BMI \> 35. Consent would be signed for sleep studies. Baseline sleep study, lung function, Epworth Sleepiness Scale (ESS) and quality of life would be assessed in patients who have symptoms suggestive of OSA. If a patient is confirmed to have OSA, a continuous positive airway pressure (CPAP) titration would be offered if the patient is willing to try CPAP. Otherwise patients would be discharged home and wait for balloon insertion. The same assessment would be repeated 3 months and 6 months after the surgical procedure. All sleep studies would be done as in-patient.

Leptin and ghrelin are hormones control satiety, which are also related to the degree of obesity. Blood for plasma leptin and ghrelin would be taken before and 6 months after gastric balloon insertion to assess the relationship of weight reduction by reducing appetite and plasma level of the hormones

Eligibility criteria: Inclusion Criteria:

* morbidly obese patients with BMI \> 30
* confirmed obstructive sleep apnea with RDI \> 10/hr
* able to sign consent

Exclusion Criteria:

* patients undergoing weight reduction surgery
* sleep apnea other than obstructive sleep apnea
* untreated endocrine disorder
* patient refusal

Primary outcomes:
measure: effect of gastric balloon on sleep apnea
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Hong Kong
country: China
facility: Prince of Wales Hospital
state: Hong Kong
Study officials:
affiliation: Prince of Wales Hospital
name: To K Wang, FHKCP, FACCP
role: PRINCIPAL_INVESTIGATOR
References: