louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00970060: Exercise and Nerve Function in Diabetes
Official title: Effectiveness of an Exercise Program on Nerve Function and Cutaneous Nerve Fibers in Adults With Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetic Neuropathy
Keywords: neuropathy
diabetes
Lead sponsor: University of Kansas Medical Center
Sponsor class: OTHER
First posted: 2009-09-02
Enrollment: 26
Sex: ALL
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP

Brief summary: The purpose of this study is to describe the effect of a 10-week exercise program on nerve function and number of nerve fibers in the skin in the lower leg in people with diabetic neuropathy.

Detailed description: The objective for this application is to quantify the benefits of exercise on nerve function including proprioception, and investigate the relationship of these findings with improvements in epidermal and dermal innervation. In this pilot project, we will pursue 2 specific aims: 1) determine the effect of an exercise intervention on nerve function in people with diabetic neuropathy, and 2) assess changes in cutaneous innervation following participation in an exercise program.

Eligibility criteria: Inclusion Criteria:

* Age 40-70
* Type 2 diabetes
* Peripheral neuropathy

Exclusion Criteria:

* Serious cardiac history or other medical problems that would prevent safe participation in exercise

Primary outcomes:
measure: Quantitative sensory testing
timeFrame: 10 weeks
measure: Nerve conduction studies
timeFrame: 10 weeks
measure: Proprioception
timeFrame: 10 weeks
measure: Dermal and epidermal nerve fiber densities
timeFrame: 10 weeks
Secondary outcomes:
measure: Clinical assessments of neuropathy, pain, body mass index, muscle strength, and glycemic control (glycosylated hemoglobin or A1C)
timeFrame: 10 weeks
Other outcomes:
Locations:
city: Kansas City
country: United States
facility: Patricia Kluding PhD
state: Kansas
Study officials:
affiliation: University of Kansas Medical Center
name: Patricia Kluding, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kluding PM, Pasnoor M, Singh R, Jernigan S, Farmer K, Rucker J, Sharma NK, Wright DE. The effect of exercise on neuropathic symptoms, nerve function, and cutaneous innervation in people with diabetic peripheral neuropathy. J Diabetes Complications. 2012 Sep-Oct;26(5):424-9. doi: 10.1016/j.jdiacomp.2012.05.007. Epub 2012 Jun 18.
Clinical trial NCT02927860: Sleep and Activity Monitoring After Thoracic Surgery
Official title: Sleep and Activity Monitoring After Thoracic Surgery
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Thoracic Surgery
Surgery, Thoracic
Keywords: sleep
exercise
activity
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2016-10-07
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Mayo Clinic Rochester patients undergoing thoracic surgery

Brief summary: Show by collecting sleep and activity data, outcomes after thoracic surgery are improved with better sleep and increased activity.

Detailed description: Little is known about how sleep deprivation affects recovery after thoracic surgery. There is some evidence that in cardiac surgery, sleep disturbance can lead to delayed recovery and mental status changes in the postoperative period. There are no similar reports of studies after thoracic surgery. We think that increased activity after surgery is beneficial for a rapid recovery and prevents blood clots, pneumonia and deconditioning. Without specific data this is difficult to prove.

Eligibility criteria: Inclusion Criteria:

* undergoing thoracic surgery at Mayo Clinic Rochester
* expected to stay in hospital for at least 4 days
* signed consent form

Exclusion Criteria:

* Unable to provide consent

Primary outcomes:
measure: Length of Stay
timeFrame: Until discharge, an average of 5 days
Secondary outcomes:
measure: Incidence of pneumonia while hospitalized
timeFrame: Until discharge, an average of 5 days
measure: Incidence of blood clot while hospitalized
timeFrame: Until discharge, an average of 5 days
measure: Incidence of deconditioning while hospitalized
timeFrame: Until discharge, an average of 5 days
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Mark S Allen, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03826160: Growth Hormone Dynamics and Cardiac Steatosis in HIV
Official title: Role of Growth Hormone in the Pathogenesis and Treatment of Cardiac Steatosis and Diastolic Dysfunction in HIV
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Human Immunodeficiency Virus
Lipodystrophy
Cardiac Disease
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2019-02-01
Enrollment: 23
Sex: ALL
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: HIV patients, age 40-70 years old, with abdominal fat accumulation

Brief summary: Cardiac steatosis is increased among individuals with HIV, and may predispose to cardiac mechanical dysfunction and subsequent heart failure. The pathogenesis and treatment of cardiac steatosis is not well understood. The investigators have previously shown that perturbed growth hormone (GH) secretion in HIV contributes to ectopic fat accumulation in the viscera and the liver. Moreover, the investigators have found that augmentation of endogenous GH secretion with the FDA-approved medication tesamorelin reduces visceral and hepatic fat. In this longitudinal observational study, the investigators will examine patients with HIV and abdominal fat accumulation who either plan or do not plan to initiate tesamorelin prescribed clinically. The investigators hypothesize that blunted GH secretion in HIV is associated with cardiac steatosis. The investigators also hypothesize that use of tesamorelin for 6 months is associated with a reduction in intramyocardial fat and preserved cardiac function.


Eligibility criteria: Inclusion Criteria:

* Men and women, ages 40-70 years
* Documented HIV infection on stable antiretroviral therapy for ≥ 3 months
* Abdominal obesity with waist circumference ≥ 102 cm in men, ≥ 88 cm in women
* Indication for tesamorelin per clinical judgment

Exclusion Criteria:

* CD4 \< 100 cells/mm3 or HIV viral load \> 400 copies/mL
* Current active AIDS-defining illness
* History or symptoms consistent with heart failure
* Standard contraindications to MRI including severe allergy to gadolinium
* Glomerular filtration rate (eGFR) \< 45 mL/min/1.73 m2 within one month of MRI study
* Use of growth hormone-releasing hormone (GHRH) or growth hormone (GH) within the past 6 months
* HbA1c \> 7%, chronic insulin use within the past 6 months, and/or change in anti-diabetic agents within the past 3 months
* Change in statin therapy within the past 3 months
* Chronic corticosteroid use except intermittent topic steroid creams or inhalers
* Pregnancy or breastfeeding

Primary outcomes:
measure: Intramyocardial lipid content
timeFrame: 6 months
Secondary outcomes:
measure: Circumferential diastolic strain rate
timeFrame: 6 months
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Steven Grinspoon, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03980860: Effect of Two Exercise Programs on Obese Patients
Official title: Effect of HIIT vs Low Intensity Training on Fat Loss in Obese Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Hypertension
Lead sponsor: Rowan University
Sponsor class: OTHER
First posted: 2019-06-10
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: This is a case/control study comparing overweight/obese patients of three different groups (control, HIIT, LIT). The goal of a case/control is to show whether exposure to HIIT, two times a week for 6 weeks will decrease lean body mass versus control and LIT. If it turns out that lean body mass does decrease, then HIIT is not an effective exercise modality for overweight/obese patients, and in fact LIT or control may be a better option.
Primary purpose: PREVENTION

Brief summary: The purpose of the study is to compare the effectiveness of two exercise programs (High Intensity Interval Training/HIIT and Low Intensity (LIT) Long Duration training) on decreasing fat mass and preserving lean body mass in obese patients. What the investigators are proposing is that HIIT is less effective because it will most likely decrease lean body mass in obese patients, whereas LIT decreases fat mass and conserves lean body tissue.


Eligibility criteria: Inclusion Criteria:

* Anyone with a BMI of 25 and above

Exclusion Criteria:

* Those that cannot exercise

Primary outcomes:
measure: Body fat
timeFrame: 6 weeks
measure: Lean body mass
timeFrame: 6 weeks
Secondary outcomes:
measure: Blood pressure
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Stratford
country: United States
facility: Rowan SOM Family Medicine
state: New Jersey
Study officials:
affiliation: Rowan University
name: Adarsh Gupta, DO
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01847560: Anticoagulant Utilization Pattern
Official title: A Description of Warfarin and NOAC Utilization Patterns Including Initiation, Switching, and Discontinuation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Atrial Fibrillation
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2013-05-07
Enrollment: 333664
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients 18 years of age and older with non-valvular AF at risk for stroke treated with oral anticoagulation

Brief summary: This study plans to describe utilization patterns for oral anticoagulants over time in patients with non-valvular atrial fibrillation at risk for stroke using electronic claims data from a United States commercial insurance database.


Eligibility criteria: Inclusion criteria:

* A recorded diagnosis of atrial fibrillation
* Initiation of oral anticoagulant medication
* Congestive Heart Failure, Hypertension, Age \> 75, Diabetes Mellitus, Prior Stroke or Transient Ischemic Attack, Vascular Disease, Age 65-74, Sex Category (CHA2DS2-VASc) Score \>=1
* At least 18 years of age on the date of anticoagulant initiation

Exclusion criteria:

* Patients with missing or ambiguous age or sex information
* Patients with documented evidence of valvular disease
* Patients with less than 12 months enrolment in the UnitedHealth Research Database preceding the first dispensing
* Patients with prior use of any oral anticoagulant

Primary outcomes:
measure: Description of the Characteristics of Anticoagulant Initiators
timeFrame: From January 2009 to September 2015 (The study period)
measure: Percentage of Patients Initiating Specific Anticoagulant
timeFrame: From January 2009 to September 2015 (The study period)
measure: Percentage of Patients Initiating Specific Anticoagulant Dose - Dabigatran
timeFrame: From January 2009 to September 2015 (The study period)
measure: Percentage of Patients Initiating Specific Anticoagulant Dose - Apixaban
timeFrame: From January 2009 to September 2015 (The study period)
measure: Percentage of Patients Initiating Specific Anticoagulant Dose - Rivaroxaban
timeFrame: From January 2009 to September 2015 (The study period)
Secondary outcomes:
measure: Treatment Persistence Over Time
timeFrame: From January 2009 to September 2015 (The study period)
Other outcomes:
Locations:
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
Study officials:
affiliation: Boehringer Ingelheim
name: Boehringer Ingelheim
role: STUDY_CHAIR
References:
Clinical trial NCT06422260: Four-unit Implant Supported Fixed Partial Dentures Fabricated From Different Materials
Official title: Clinical and Radiographic Outcomes of Four-unit Implant Supported Fixed Partial Dentures Fabricated From Different Materials
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Prosthesis Survival
Bone Loss
Lead sponsor: Menoufia University
Sponsor class: OTHER
First posted: 2024-05-20
Enrollment: 60
Sex: ALL
Minimum age (years): 30
Maximum age (years): 50
Standard ages: ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 60 participants who needed an implant-supported fixed partial denture (FPD) in the esthetic zone.

Brief summary: Implant supported superstructure is necessary for long term success and durability of the implant itself in terms of stresses distribution and fracture strength capability. Stresses falling on an implant are too much greater than those applied on a tooth structure with a periodontal ligament offering a degree of elasticity. The important mechanical and physical properties of materials used for the fabrication of dental prostheses include adequate flexural and tensile strength and modulus of elasticity, maximum fracture resistance, optimal bond strength and adequate polishability.

Detailed description: One objective of implant dentistry is to provide excellent esthetics and soft-tissue profiles in the esthetic zone. Esthetic requirements have focused primarily on the position, inclination, shape, and color of the restoration. However, the peri-implant soft tissue also plays a major role in the esthetics of an implant-supported restoration especially in the anterior region.

Eligibility criteria: Inclusion Criteria:

* No systemic diseases that might alter the tissue response to implantation.
* Mobility grade 3 at the site of the 4 lateral incisors.
* sufficient available inter-arch space
* normal maxillomandibular relation.
* no temporomandibular joint

Exclusion Criteria:

* Grade 1 or 2 mobility at the incisor's region.
* Patients with systematic diseases that contraindicate implant placement.

Primary outcomes:
measure: Bone loss
timeFrame: 4 years
Secondary outcomes:
measure: Clinical performance of the prosthesis superstructure
timeFrame: 4 years
Other outcomes:
Locations:
city: Mansoura
country: Egypt
facility: Mohammed A. El-Sawy
Study officials:
affiliation: Menoufia University
name: Mohammed A. El-Sawy, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05809960: The Effect of Nursing Support Program for Women in Surgical Menopause on Their Life Quality
Official title: The Effect of Nursing Support Program Developed in Accordance With Roy Adaptation Model for Women in Surgical Menopause on Their Life Quality
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Nursing Caries
Surgical Menopause
Quality of Life
Keywords: Nursing support program
Roy Adaptation Model
Depressive symptom status
Sleep quality
Lead sponsor: T.C. ORDU ÜNİVERSİTESİ
Sponsor class: OTHER
First posted: 2023-04-12
Enrollment: 77
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Objective: The aim of this study was to determine the effect of the nursing support program developed in line with the Roy Adaptation Model on the quality of life, sleep quality and depressive symptom status of women in surgical menopause.

Design: The study was a single-center, randomized, controlled trial. Setting: This study was carried out in the gynecology clinic of a training and research hospital in Türkiye.

Method: The participants were randomized into two equal groups: intervention and control. The nursing support program developed in addition to routine nursing care was applied to the intervention group. Routine nursing care was given to the women in the control group. Data were collected with "Personal Information Form", "Menopause-Specific Quality of Life Questionnare", "Pittsburgh Sleep Quality Index" and "Perimenopausal Depression Scale".

Hypothesis:

H0-a: Nursing support program developed in line with the Roy Adaptation Model has no effect on the quality of life of women who have undergone surgical menopause.

H0-b: Nursing support program developed in line with the Roy Adaptation Model has no effect on the sleep quality of women who have undergone surgical menopause.

H0-c: Nursing support program developed in line with the Roy Adaptation Model has no effect on the depressive symptom status of women who have undergone surgical menopause.


Eligibility criteria: Inclusion Criteria:

* To have undergone surgical menopause
* To be literate
* To agree to participate in the study

Exclusion Criteria:

* To have natural menopause before the operation
* To have an oncological disease
* To have a psychiatric disease
* To use sleeping pills
* To use hormonal therapy
* To have physical and mental disability
* To have barrier to communication

Primary outcomes:
measure: Life quality
timeFrame: 6 months
measure: Sleep quality
timeFrame: 6 months
measure: Depressive symptom status
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Ordu
country: Turkey
facility: Ordu University
Study officials:
References:
Clinical trial NCT00287560: Effect of a Modified Propofol Preparation on Injection Pain During Induction of Anesthesia in Children
Official title: A Comparison of Venous Tolerability and Injection Pain of a Modified Propofol Preparation and Standard Propofol in the Induction of Anesthesia in Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Anesthesia
Lead sponsor: B. Braun Melsungen AG
Sponsor class: INDUSTRY
First posted: 2006-02-07
Enrollment: 64
Sex: ALL
Minimum age (years): 2
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of the study is to determine wether a modified propofol preparation shows any effect on the incidence of injection pain in children undergoing elective surgery under general anesthesia.

Study hypothesis: The use of a modified propofol preparation will reduce the incidence of injection pain in the study group.

Detailed description: Pain on injection is the most frequently reported side effect associated with the use of propofol for induction of anesthesia. Various measures have been taken to reduce the pain on injection, e.g. administration of lidocaine or fentanyl prior to propofol administration, mixture of lidocaine and propofol as well as cooling of the emulsion. Although pain on injection had been reduced with some of the above mentioned methods, they may not be regarded as a satisfactory solution of the problem.

Eligibility criteria: Inclusion Criteria:

* age \>= 2 and \< 6 years
* written informed consent of the parents
* anesthetic risc classified as ASA I - III
* patient undergoing elective surgery under general anesthesia
* venous access for induction of anesthesia on the dorsum of the hand
* hospital care for at least 3 hrs after end of anesthesia guaranteed

Exclusion Criteria:

* intolerability of the drugs tested
* current drug medication with sedative effect
* patient is expected to require concomitant medication not allowed in the study
* history of or current renal or hepatic disease, cardiac insufficiency
* hypovolemia
* increased cranial pressure
* simultaneous participation in another clinical trial or participation during the month preceding this study

Primary outcomes:
measure: incidence of spontaneous expression of pain during injection
Secondary outcomes:
measure: anesthetists VAS for assessment of injection pain, propofol dosage and requirements, hemodynamic parameters, safety laboratory, adverse events
Other outcomes:
Locations:
Study officials:
affiliation: Klinik für Anästhesie und operative Intensivmedizin, Klinikum Leverkusen gGmbH
name: Gerd P Molter, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05644860: Nano Composites and Light Cure Composites - A Comparative Assessment of Bond Failure Rates
Official title: Nano Composites and Light Cure Composites - A Comparative Assessment of Bond Failure Rates
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Nanotechnology, Dental Materials, Composites
Lead sponsor: Foundation University Islamabad
Sponsor class: OTHER
First posted: 2022-12-09
Enrollment: 40
Sex: ALL
Minimum age (years): 12
Maximum age (years): 35
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The patients meeting the slection criteria chall be randomly allocated in two groups (A and B)/ Brackets in the group A shall be bonded with the conventional composite (Transbond XT, 3M Unitek, USA) with appreciably good shear bond strength. In patients belonging to group B, brackets shall be bonded with nanohybrid composite (Filtek Z250).

Long term succes shall be evaluated by comparing the bracket failute rate between the two groups.
Primary purpose: TREATMENT

Brief summary: This randomized clinical trial is aimed to evaluate the bond failure rates of the brackets bonded with nano-hybrid composites (Filtek Z250) to that of conventional composites (Transbond XT)

Detailed description: Orthodontic brackets are attached to the teeth with a robust bonding material called composite resin, however sometimes the bond between the braket and the tooth surface may fail halting the desired tooth movement. Repeated bond failures like these are inconvenience both for the orthodontists as well as the patients. With each bracket loosening due to bond failure, treatment time is prolonged as the activation planned on eash visit is delayed resuling in increased treatment time.

Nanotechnology has recently made a breakthrough in dental materials through incorporation of nanoparticles. Composites containing nano-filler particles exhibit higher compression strength, flexural strength, elastic modulus and wear resistance (Rabia and Bilal). In vitro studies have shown that nanohbrid composites have shear bond stregnths similar to that of conventional composites however the environment of oral cavity is challenging and there are no long term clinical trials to validate these results.

The aim of this study is to compare the rate of bond failure between the brackets bonded with nano hybrid composites and that of the conventional composites over a period of six months.

Eligibility criteria: Inclusion Criteria:

* Patients having treatment with fixed metallic orthodontic appliances
* Patients in whom both upper and lower arches are bonded in single visit

Exclusion Criteria:

* Patients with variations in morphology of teeth
* Patients with defective enamel, dentine and cementum
* Patiens with parafunctioal habits
* Patients with restorations involving the facial surface of teeth

Primary outcomes:
measure: Bracket failure rate
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Islamabad
country: Pakistan
facility: Foundation University Islamabad
state: Islamabad/ Federal
Study officials:
References: