louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02458313: Nicotinic Agonist Effects on BMI and Neuronal Response
Official title: Nicotinic Agonist Effects on BMI and Neuronal Response in Overweight/Obese Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Obesity
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
First posted: 2015-06-01
Enrollment: 61
Sex: ALL
Minimum age (years): 21
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Obesity is a serious and growing health problem in the United States. Obesity is associated with health problems such as type-2 diabetes and cardiovascular disease, leading to decreased quality of life and increased mortality. Given the health and quality-of-life effects of obesity, developing effective treatments clearly is an important goal.

This study plans to learn more about the effects of an investigational new drug (DMXB-A (3-(2,4-dimethoxybenzylidene anabaseine)) and its effects on obesity. The study drug has similar effects to nicotine. Since nicotine has been found to affect appetite, the investigators are interested in studying effects of the study drug, which has some similarities to nicotine, on how your brain responds to such things as pictures of food. The study drug has not been approved by the Food and Drug Administration (FDA), and is considered experimental.


Eligibility criteria: Inclusion Criteria:

* Overweight/obese (BMI \> 27)
* Between 21-65 years old

Exclusion Criteria:

* Known cardiovascular disease (e.g., coronary artery disease, uncontrolled hypertension
* Women capable of conception (must be post-menopausal, surgically sterilized, or have adhered to an anti-contraception birth control regimen for at least 1 year)
* Nicotine use
* Significant endocrine/metabolic disease
* Kidney disease
* Neurological illness
* Liver disease
* Medication use affecting appetite and/or metabolism
* MRI-specific exclusion criteria (e.g., claustrophobia, metal in the body)

Primary outcomes:
measure: Neuronal Response to Visual Food Cues
timeFrame: 14 weeks
measure: Resting-state Neuronal Response
timeFrame: 14 weeks
Secondary outcomes:
measure: Body Weight
timeFrame: 14 weeks
measure: Fat Mass
timeFrame: 14 weeks
measure: Appetite Rating
timeFrame: 14 weeks
Other outcomes:
Locations:
city: Denver
country: United States
facility: University of Colorado
state: Colorado
Study officials:
affiliation: University of Colorado, Denver
name: Jason Tregellas, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00627913: Retrobulbar Injection of Anesthesia Versus Healon 5 in the Management of Intraoperative Floppy Iris Syndrome
Official title: Retrobulbar Injection of Anesthesia Versus Injection of Healon 5 Viscoelastic Into the Anterior Chamber in the Management of Intraoperative Floppy Iris Syndrome
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Intraoperative Floppy Iris Syndrome
Keywords: Floppy Iris Syndrome
Lead sponsor: Penn State University
Sponsor class: OTHER
First posted: 2008-03-04
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: In this study, the investigators plan to compare the incidence and complications of intraoperative floppy iris syndrome (IFIS) during cataract surgery in patients taking tamsulosin (Flomax) and treated with retrobulbar injection of anesthesia, versus injection of Healon 5 viscoelastic into the anterior chamber.


Eligibility criteria: Inclusion Criteria:

* All cataract patients taking tamsulosin

Exclusion Criteria:

* Patients with any history of iridocyclitis
* Presence of iris neovascularization
* History of prior iris surgery
* Presence of traumatic cataracts
* Presence of zonular dialysis

Primary outcomes:
measure: Pupil diameter after hydrodissection
timeFrame: 2 years
Secondary outcomes:
measure: Pupil diameter after nuclear removal
timeFrame: 2 years
measure: Pupil diameter after cortex removal
timeFrame: 2 years
measure: Pupil diameter at conclusion of surgery
timeFrame: 2 years
Other outcomes:
Locations:
city: Hershey
country: United States
facility: Penn State Hershey Eye Center
state: Pennsylvania
Study officials:
affiliation: The Penn State Hershey Eye Center
name: Ahmad A Aref, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Chang DF, Osher RH, Wang L, Koch DD. Prospective multicenter evaluation of cataract surgery in patients taking tamsulosin (Flomax). Ophthalmology. 2007 May;114(5):957-64. doi: 10.1016/j.ophtha.2007.01.011.
Clinical trial NCT02713113: Efficacy of Low Dose Sugammadex in Reversal of NMB in Laparoscopic Barbaric Surgery
Official title: Comparison of Three Different Doses Sugammadex Based on Ideal Body Weight for Reversal of Moderate Rocuronium-induced Neuromuscular Blockade in Laparoscopic Bariatric Surgery.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Bariatric Patients
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2016-03-18
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: the investigators aimed to compare the efficacy and safety of sugammadex at doses of 1.5, 2, and 4 mg/ kg for the reversal of moderate rocuronium-induced neuromuscular blockade in laparoscopic bariatric surgery.

Detailed description: Patients were randomly assigned using a randomization-computer program into three groups according to the dose of sugammadex administrated (according to the IBW after T2 of TOF):

Group I: patients were given 1.5 mg / kg. Group II: patients were given 2 mg / kg. Group III: patients were given 4 mg / kg.

Eligibility criteria: Inclusion Criteria:

* morbidly obese patients of both sex (BMI \> 40 kg.m-2)
* scheduled for elective laparoscopic bariatric surgery (gastric bypass or sleeve surgery) under general anesthesia using rocuronium for tracheal intubation and maintenance of NMB
* aged between 18 and 60 years and classified as ASA II - III

Exclusion Criteria:

* liver and renal dysfunction,
* disabling neuropsychiatric disorders,
* history of stroke, brain trauma in the last 12 months
* hypersensitivity to anesthetics, history of myocardial infarction, congestive heart failure
* difficult tracheal intubation, and known or suspected disorder affecting NMB.

Primary outcomes:
measure: sugammadex time following a dose of 1.5 mg / kg of sugammadex according to IBW in comparison to 2, and 4 mg / kg,
timeFrame: 2 hrs
Secondary outcomes:
measure: extubation time
timeFrame: 2 hrs
Other outcomes:
Locations:
city: Assuit
country: Egypt
facility: South Egypt Cancer Instuite
Study officials:
affiliation: ASSUIT UNVERSITY
name: Ahmed H Othman, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT00466713: Defining the Role of Insulin Resistance in 'Idiopathic' Dilated Cardiomyopathy
Official title: Defining the Role of Insulin Resistance in 'Idiopathic' Dilated Cardiomyopathy
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Dilated Cardiomyopathy
Keywords: Nonischemic dilated cardiomyopathy
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2007-04-27
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP

Brief summary: This study will investigate the effects of rosiglitazone, a medicine commonly used to treat type 2 diabetes, on the utilization of glucose by the heart in patients with heart failure which is not due to heart attacks. The primary purpose of the study is to determine whether treatment with an insulin-sensitizing medication will improve the heart's ability to metabolize glucose (sugar).

Detailed description: Nondiabetic patients with nonischemic cardiomyopathy who are insulin-resistance or insulin-sensitive based on a fasting homeostasis model assessment (HOMA) value are eligible for the trial. At baseline, a 6-minute walk test is performed, followed by assessment of coronary flow reserve with ammonia-PET imaging before/after adenosine infusion. Subjects are then given an oral glucose load (75g), followed by PET imaging with F-18-fluoro-2-deoxyglucose (FDG). Subjects then begin taking rosiglitazone 4 mg qd x 12 weeks, after which the 6-minute walk test \& PET imaging is repeated.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of nonischemic dilated cardiomyopathy, current NYHA class I-II congestive heart failure
* History of Stage C-D heart failure with EF ≤ 40% during the course of the disease
* Treatment with a stable comprehensive heart failure regimen for at least 3 months (including beta-blockers and ACE-inhibitors or angiotensin receptor blockers unless intolerant)
* Age \> 18 yrs

Exclusion Criteria:

* Cardiomyopathy due to one of the following:

  * Ischemic heart disease
  * Primary valvular lesion
  * Hypertrophic cardiomyopathy
* Cardiac resynchronization within the last 3 months
* Transaminase values \> 2.5 x upper limit of normal or history of liver disease
* Diagnosis of diabetes mellitus by:

  * Diabetes previously diagnosed per patient history
  * 2 or more fasting glucose values \> 125 mg/dl
* Current NYHA class III or IV heart failure
* Serum creatinine \> 1.6 mg/dl
* History of heart transplantation
* Pregnancy or active breast feeding
* Hospitalization for decompensated heart failure within 30 days prior to enrollment.

Primary outcomes:
measure: Myocardial glucose uptake (intrasubject before/after rosiglitazone)
measure: Myocardial glucose uptake (between insulin-resistant & insulin-sensitive groups)
Secondary outcomes:
measure: Coronary flow-reserve
measure: 6-minute walk time
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University Hospital
state: California
Study officials:
affiliation: Stanford University
name: Michael Fowler, MB
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05684913: The Effects of Zn-containing Granulate on Patient Morbidity and Wound Healing After Free Gingival Graft Surgery
Official title: Cukurova University Faculty of Dentistry
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Surgery
Keywords: free gingival graft surgery
surgical stent
zinc
pain
bleeding
Lead sponsor: Cukurova University
Sponsor class: OTHER
First posted: 2023-01-13
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: There is no study in the literature showing the effects of Zn on wound healing after free gingival graft (FGG) operation. The aim of this randomized clinical study was to compare the early healing results of the palatal wound after FGG harvesting by sterile hemostatic agent suturing or the use of surgical stent from thermoplastic Zn-containing granules which was prepared chairside.

Detailed description: There are many studies reporting paresthesia, herpetic lesion, mucocele, excessive bleeding and severe postoperative pain after procedure.The highest pain level perceived in the palatal region after the FGG operation is experienced on the first day after the operation and decreases to the preoperative levels approximately 2 weeks after the operation. Although hemostatics, bioactive substances, antibacterial and antiseptic agents, herbal effective products, platelet concentrations, low-dose laser applications, palatal stents are used in the palatal region to accelerate the healing stages and prevent such complications, an ideal support has not been found.

Eligibility criteria: Inclusion Criteria:

* Periodontal and systemically healthy

  * ≥19 years old
  * Amount of attached gingival width in the maxillary or mandibular anterior region \<2 mm
  * Full mouth plaque index score, bleeding index score on full-mouth probing \<15%

Exclusion criteria;

* Previously undergone surgery for a graft harvested from the palate
* Presence of systemic disease
* Taking medication known to interfere with periodontal health
* Smoking

Primary outcomes:
measure: Post-operative pain
timeFrame: post operative 8 weeks
Secondary outcomes:
measure: Bleeding
timeFrame: post operative 7 days
measure: Burning sensation
timeFrame: post operative 8 weeks
measure: Change in dietary habits
timeFrame: post operative 8 weeks
measure: Complete epithelization
timeFrame: post-operative 8 weeks
measure: Patient discomfort
timeFrame: post-operative 8 weeks
Other outcomes:
Locations:
city: Adana
country: Turkey
facility: Cukurova University Faculty of Dentistry
Study officials:
affiliation: Professor
name: Cenk Haytac
role: STUDY_DIRECTOR
References:
Clinical trial NCT05865613: Effect of Electromagnetic Therapy on Patients With Chronic Rhinosinusitis.
Official title: Effect of Pulsed Electromagnetic Field Therapy on Headache, Fatigue, and CT Finding on Patients With Chronic Rhinosinusitis.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Magnetic Therapy
Rhinosinusitis
Headache
Fatigue
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2023-05-19
Enrollment: 37
Sex: ALL
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study aimed to evaluate the efficacy of Pulsed electromagnetic field (PEMF) for Chronic sinusitis in a randomized, double-blind, placebo-controlled trial.

Detailed description: Chronic sinusitis, or chronic rhinosinusitis, is an inflammatory condition defined by symptomatic inflammation of the paranasal sinuses lasting longer than 3 months. Common presenting symptoms include nasal obstruction, facial pressure or fullness, nasal discharge (anterior or posterior), and olfactory loss. Furthermore, chronic sinusitis is associated with reductions in patient quality of life, sleep quality, and daily productivity.

A pulsed electromagnetic field (PEMF) has an anti-inflammatory, antimicrobial, and improves the microcirculation of the mucosal membrane of the nasal cavity. It has been suggested that magnetic therapy can be used in treating chronic sinusitis but there is a scarce of studies about its usage.

Eligibility criteria: Inclusion Criteria:

* patients suffering from mild to moderate symptoms of rhinosinusitis.

Exclusion Criteria:

* pregnant or breastfeeding women.
* patients with definite deviated nasal septum, sinusitis, or history of operation within the last 6 months.
* patients with hypertension, diabetes mellitus, malignancy, active pulmonary tuberculosis, infection, active respiratory disease like asthma, or other systemic diseases.
* patients with long-term use of corticosteroids or immunosuppressive agents.
* patients who were involved in another clinical study within 30 days.
* patients who were unable to comply with the follow-up schedules.
* patients who had used antihistamines within 1 week, topical corticosteroids within 2 weeks, systemic corticosteroids within 4 weeks, anti-cholinergic drugs within 3 days, antileukotriene drugs within 1 week, decongestants within 3 days, tricyclic antidepressants or phenothiazines within 2 weeks, non-steroidal analgesics within 2 weeks, and other drugs which the researchers believed were inappropriate.

Primary outcomes:
measure: Headache
timeFrame: Baseline and one month.
Secondary outcomes:
measure: Fatigue
timeFrame: Baseline and one month.
measure: CT finding
timeFrame: Baseline and one month.
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: Faculty of physical therapy, Cairo university
state: Dokki
Study officials:
References:
Clinical trial NCT00950313: Assessment of Response Rates and Yields for Two Tools for Early Detection of Non-diabetic Hyperglycaemia and Diabetes
Official title: Assessment of Response Rates and Yields for Two Tools for Early Detection of Non-diabetic Hyperglycaemia and Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes
Keywords: Diabetes
Screening
Risk
Self assessment
Lead sponsor: University of Leicester
Sponsor class: OTHER
Collaborators: name: University Hospitals, Leicester
First posted: 2009-07-31
Enrollment: 432
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief summary: The purpose of this study is to establish the most effective method of increasing attendance to screening of type 2 Diabetes within a primary care setting within the backdrop of the NHS Health Check programme.

Detailed description: The University Hospitals of Leicester and The University of Leicester have developed a self-assessment risk score and a practice data risk score that can be used in a variety of setting to detect undiagnosed diabetes and impaired glucose regulation. This is done to establish a simple and effective 1st stage screen to identify those people at risk of diabetes and engage the public to increase the number of high risk individuals attending screening invitations but reducing the overall number of oral glucose tolerance tests. This study aims to test in a pragmatic way the use of such tools in a primary care setting administered by primary care staff as part of the NHS Health Check programme.

Eligibility criteria: Inclusion Criteria:

* 40-75 years old (30 -75 years old if South Asian origin)

Exclusion Criteria:

* Current diagnosis of diabetes
* Terminal illness or mental incapacity

Primary outcomes:
measure: Increase in response rates to invitation to 2nd stage blood test
timeFrame: 12 months
Secondary outcomes:
measure: Increase in yield of OGTT positive results through filtering of high risk participants that pass 1st and 2nd stage screens
timeFrame: 12
Other outcomes:
Locations:
city: Leicester
country: United Kingdom
facility: Leicester City PCT
state: Leicestershire
Study officials:
affiliation: University of Leicester
name: Kamlesh Khunti, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02119013: Effects of Somatostatin on ADPKD Heart
Official title: EFFECT OF SOMATOSTTIN ON EARLY DIASTOLIC LEFT VENTRICULAR FUNCTION IN AUTOSOMAL DOMINANT POLYCYSTIC KIDNEY DISEASE: A MATCHED-COHORT, SPECKLE-TRACKING ECHOCARDIOGRAPHIC STUDY
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Autosomal Dominant Polycystic Kidney Disease
Glomerular Filtration Rate > 40 ml/Min
Lead sponsor: Federico II University
Sponsor class: OTHER
First posted: 2014-04-21
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Autosomal dominant polycystic kidney disease (ADPKD) is associated with early onset hypertension and left ventricular (LV) hypertrophy. Since LV hypertrophy is associated with LV diastolic function impairment, we aimed to assess the changes over time of LV diastolic function in ADPKD patients and whether they were affected by the treatment with the somatostatin analogue, octreotide.

35 ADPKD patients (14 males) aged 34±8 years (mean glomerular filtration rate 82±26 mL/min/1.73m2) were randomly assigned to 36 month treatment with placebo (n=18) or octreotide (n=17). Clinical and echocardiography parameters were evaluated at baseline and study end. LV mass (M) and ejection fraction (EF) were calculated according to Devereux formula and biplane Simpson's algorithm, respectively. LV filling was assessed by mitral and pulmonary vein flow velocity curves and mitral annulus early diastolic velocity peak (Ea) by tissue Doppler imaging.


Eligibility criteria: Inclusion Criteria:

* diagnosis of autosomal dominant polycystic kidney disease
* glomerular filtration rate grater than 40 ml/min

Exclusion Criteria:

* diabetes mellitus
* proteinuria greater than 1 g/24 hours
* significant glomerular disease
* urinary tract lithiasis and infections
* symptomatic gallstones
* biliary sludge
* cancer
* pregnant women
* lactanting women

Primary outcomes:
measure: EFFECT ON LEFT VENTRICULAR DYASTOLIC FUNCTION
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Federico II University
name: eleonora riccio, md
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04568213: Hypochlorous Acid Disinfection Prior to Cataract Surgery
Official title: Effect of Hypochlorous Acid Disinfection on Ocular Flora Prior to Cataract Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Cataract
Endophthalmitis
Keywords: Ocular/Eyelid Flora
Lead sponsor: Loma Linda University
Sponsor class: OTHER
First posted: 2020-09-29
Enrollment: 54
Sex: ALL
Minimum age (years): 18
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: Antibiotics are commonly utilized to reduce the bacterial population of the eye prior to surgery with the assumption that this reduces the risk of endophthalmitis, although it is not clear if this actually occurs. This study will investigate the use of Hypochlorous Acid, a commercially available over the counter (OTC) medication to see if this will reduce the bacterial population prior the cataract surgery.


Eligibility criteria: Inclusion Criteria:

- Patients undergoing cataract surgery.

Exclusion Criteria:

* Age \<18 years old
* Vulnerable subjects
* Non-English Speakers

Primary outcomes:
measure: Reduction in bacterial flora in eyelashes of treatment eye compared to fellow eye
timeFrame: On day of surgery prior to surgical prep
measure: Reduction in bacterial flora in conjunctiva of treatment eye compared to fellow
timeFrame: On day of surgery prior to surgical prep
Secondary outcomes:
Other outcomes:
Locations:
city: Loma Linda
country: United States
facility: Loma Linda University Health
state: California
Study officials:
affiliation: Loma Linda University Department of Ophthalmology
name: Jeffrey J Ing, MD
role: PRINCIPAL_INVESTIGATOR
References: