louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05746910: Patient's Perception of Exercise After Bone Tumor Resection-A Qualitative Study
Official title: Patient's Perception of Exercise After Bone Tumor Resection-A Qualitative Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Bone Cancer Tumor
Keywords: bone cancer tumor
exercise
Patient
Lead sponsor: Istanbul Medeniyet University
Sponsor class: OTHER
First posted: 2023-02-28
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Individuals who have been diagnosed with a bone tumor for the first time and who have undergone resection surgery

Brief summary: The aim of this study is to investigate the opinions of patients who have undergone bone tumor resection surgery about post-op exercises.

Detailed description: Semi-structured in-depth individual interviews will be conducted with patients who have undergone bone tumor surgery. In in-depth individual interviews, the same questions will be asked to all participants and the verbal answers to these questions will be recorded with voice recorders. Compared to taking notes by hand; It will be preferable to record the conversation with a voice recorder because it has advantages such as recording all the interviews and allowing the interviewer to focus on the interview. Thematic analysis method will be used in the evaluation of the data.

Eligibility criteria: Inclusion Criteria:

* Individuals aged between 18 and 65,
* Individuals without communication problems,
* Individuals who have been diagnosed with a bone tumor for the first time and who have undergone resection surgery
* Patients who have previously received therapeutic exercises

Exclusion Criteria:

* Uncontrollable arrhythmia and/or hypertension
* Presence of advanced sensory deficit
* Visual and hearing problems
* Not having sufficient communication skills (Mini-Mental Test score below 24 points)
* Patients undergoing head and neck bone resection

Primary outcomes:
measure: Semi-structured in-depth individual interviews about Patient's Perceptions of post-op exercises
timeFrame: baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Emel Mete
Study officials:
References:
Clinical trial NCT03423810: Assessing a Dose-Response Relationship of Hydralazine and Its Effects on DNA Methyltransferase 1 in Polycystic Kidney Disease Patients
Official title: Assessing a Dose-Response Relationship of Hydralazine and Its Effects on DNA Methyltransferase 1 in Polycystic Kidney Disease Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Polycystic Kidney Diseases
Lead sponsor: University of Kansas Medical Center
Sponsor class: OTHER
First posted: 2018-02-06
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to find a protein (ex. Polycystin 1 or mucin and cadherin like protein) in the urine that is changed after treatment of hydralazine.


Eligibility criteria: Inclusion Criteria:

* Confirmed diagnosis of ADPKD
* estimated glomerular filtration rate (eGFR) \> 60 ml/min/1.73m\^2

Exclusion Criteria:

* History of systemic lupus erythematous or other rheumatologic disorder
* Baseline anti-nuclear antibody (ANA) \>1:80 for females and \>1:40 for males
* Blood pressure \< 120/80 without anti-hypertensive
* Angina pectoris or myocardial infarction in the last 6 months
* Liver disease
* Allergy to hydralazine

Primary outcomes:
measure: Change in polycystin-1 (PC1)
timeFrame: Change from Baseline to Week 8
measure: Change in mucin-like protocadherin (MUPCDH)
timeFrame: Change from Baseline to Week 8
Secondary outcomes:
measure: Circulating methylated RASAL1 levels
timeFrame: Change from Baseline to Week 8
Other outcomes:
Locations:
city: Kansas City
country: United States
facility: University of Kansas Medical Center
state: Kansas
Study officials:
affiliation: University of Kansas Medical Center
name: Kerri McGreal, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05132010: Prevalence of Gummy Smile and Its Causes Among the Egyptian Population.
Official title: Prevalence of Gummy Smile: Cross-Sectional Study on A Sample of Egyptian Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Gummy Smile
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2021-11-23
Enrollment: 444
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Egyptian population

Brief summary: prevalence of gummy smile among the Egyptian population

Detailed description: prevalence of gummy smile among Egyptian population in patients attending the kasr el aini hospital

Eligibility criteria: Inclusion Criteria:

* patients attending El kasr el Aini hospital at the department of periodontology.
* patients whose above 18 years old of both genders
* patients consulting the outpatient clinic
* provide informed consent

Exclusion Criteria:

* less than 18 years old
* patients having problems opening their mouth or undergoing inter maxillary fixation where oral examination will not be possible
* patients diagnosed with psychiatric problems or intoxicated with alcohol or drugs
* patients with gingival hyperplasia
* patients with extracted maxillary anterior teeth

Primary outcomes:
measure: prevalence of gummy smile
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
measure: determining associated risk factors and classifying them onto further sub analytical groups
timeFrame: through study completion, an average of 1 year
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: Faculty of dentistry , Cairo university
Study officials:
References:
Clinical trial NCT04420910: Non-motor Symptoms, Balance, Muscle Strength, and Functional Mobility in Patients With Parkinson's Disease
Official title: Investigation of Non-motor Symptoms, Balance, Muscle Strength, and Functional Mobility in Patients With Parkinson's Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Parkinson Disease
Balance
Muscle Strength
Mobility
Non-motor Symptoms
Lead sponsor: Ankara Yildirim Beyazıt University
Sponsor class: OTHER
First posted: 2020-06-09
Enrollment: 44
Sex: ALL
Minimum age (years): 50
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: being diagnosed with PD by a neurologist, being in Hoehn \& Yahr Stage 1-3 and healthy individuals of similar age and sex

Brief summary: The purposes of this study is to examine balance, muscle strength, and mobility in relation with non-motor symptoms (NMSs) in patients with Parkinsosn's Disease (PD).

NMSs have been shown to be the key determinant of health-related quality of life (HRQoL) and have a greater effect on HRQoL compared to motor symptoms.Despite a growing literature on NMSs, there are few data on the association between NMSs and motor phenotypes of PD, and they have usually focused only on specific domains of NMSs, such as cognition, mood/anxiety issues, or sleep disorders.

When literature is examined, there is no study which examines balance, muscle strength, and mobility in relation with NMSs in patients with PD.For all these reasons, we think that balance, muscle strength, mobility, and NMSs in patients with PD are worse than those of the healthy individuals and that there is a relationship between NMSs and motor symptoms.


Eligibility criteria: Inclusion Criteria:

* being diagnosed with PD by a neurologist, being in Hoehn \& Yahr Stage 1-3, having no musculoskeletal system problems in the previous 6 months, having a score of 24 or more in the Mini-Mental State Examination (MMSE), and being volunteer.

Exclusion Criteria:

* Healthy individuals of similar age and sex, without neurological problems, and who did not experience any musculoskeletal system problems in the previous 6 months were included in the control group.

Primary outcomes:
measure: Non-Motor Symptoms
timeFrame: one hour
measure: Balance
timeFrame: one hour
measure: Lower limb strength
timeFrame: one hour
measure: Functional mobility
timeFrame: one hour
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Ankara Yıldırım Beyazıt University, Faculty of Health Sciences,Department of Physiotherapy and Rehabilitation
state: Esenboğa
Study officials:
References:
Clinical trial NCT04290910: A Pilot Study Evaluating a Clinically Managed Weight Loss Program
Official title: A Pilot Study Evaluating the Clinically Managed Weight Loss Program At the Wellness Institute At Seven Oaks General Hospital
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Keywords: pilot study
program evaluation
nutrition
exercise
psychology
Lead sponsor: University of Manitoba
Sponsor class: OTHER
First posted: 2020-03-02
Enrollment: 43
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: This is a pilot study evaluating a clinically managed weight loss program. The program consists of a 17-week weight loss program which involves a multidisciplinary team where personalized interventions are given to participants from the team based on the participants goals.

Detailed description: The clinically managed weight loss program is managed by a clinical team including a Program Manager, Registered Dietitians, Canadian Society of Exercise Physiology-Certified Personal Trainers, Clinical Psychology Associate or Cognitive Behavioural Therapist, and a Physician. The team will collaborate together to prescribe a plan best suited for the participants' needs with the focus on lifestyle changes, such as, sleep, mental health, and behaviours. Outcome measures will be collected as part of the pilot study, such as, anthropometric measurements and body composition, cardiovascular assessment, clinical chemistry, physical activity, nutrition, and behaviour and health screening questionnaires.

Eligibility criteria: Inclusion Criteria:

* Participant is willing and able to give informed consent for participation in the trial.
* Male or female, aged 18 years or above.
* Are overweight or obese (BMI over 24.9)

Exclusion Criteria:

- Female participant who is pregnant or lactating.

Primary outcomes:
measure: Body Weight Loss
timeFrame: 4 months
Secondary outcomes:
measure: Changes in Quality of Life
timeFrame: 4 months
measure: Changes in Sleep Quality
timeFrame: 4 months
Other outcomes:
measure: Attendance
timeFrame: 4 months
measure: Intervention Adherence
timeFrame: 4 months
measure: Waist Circumference
timeFrame: 4 months
measure: Body fat percentage
timeFrame: 4 months
measure: Lean mass percentage
timeFrame: 4 months
measure: Systolic Blood Pressure
timeFrame: 4 months
measure: Diastolic Blood Pressure
timeFrame: 4 months
measure: Heart Rate
timeFrame: 4 months
measure: Total cholesterol
timeFrame: 4 months
measure: High density lipoprotein cholesterol
timeFrame: 4 months
measure: Low density lipoprotein cholesterol
timeFrame: 4 months
measure: Triglyceride
timeFrame: 4 months
measure: total cholesterol and high density lipoprotein cholesterol ratio
timeFrame: 4 months
measure: Hemoglobin A1C
timeFrame: 4 months
Locations:
city: Winnipeg
country: Canada
facility: Wellness Institute
state: Manitoba
Study officials:
References:
Clinical trial NCT01969110: Additional Effects of Perioperative Immunonutrition in Patients Undergoing Pancreaticoduodenectomy
Official title: Additional Effects of Perioperative Immunonutrition on Th1/Th2 Differentiation in Patients Undergoing Pancreaticoduodenectomy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Pancreatic Tumor
Bile Duct Tumor
Keywords: Immunonutrition
Lead sponsor: Chiba University
Sponsor class: OTHER
First posted: 2013-10-25
Enrollment: 60
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: PREVENTION

Brief summary: The purpose of this study is to investigate whether perioperative immunonutrition has additional effects on cell-mediated immunity in patients undergoing pancreaticoduodenectomy.

Detailed description: The investigators reported that perioperative immunonutrition had no additional effects compared with preoperative immunonutrition in patients underwent colorectal surgery (Braga M, Gianotti L, Vignali A, Carlo VD. Preoperative oral arginine and n-3 fatty acid supplementation improves the immunometabolic host response and outcome after colorectal resection for cancer. Surgery. 2002; 132:805-14, PMID: 12464864). Object of this study is to investigate the additional effects of perioperative immunonutrition on cell-mediated immunity and incidence of infectious complication after pancreaticoduodenectomy.

Eligibility criteria: Inclusion Criteria:

* patients undergoing pancreaticoduodenectomy

Exclusion Criteria:

* age younger than 18 years old
* ongoing infection
* gastrointestinal obstruction
* respiratory dysfunction
* cardiac dysfunction
* hepatic dysfunction
* renal failure
* history of recent immunosuppressive or immunological disease
* preoperative evidence of widespread metastatic disease

Primary outcomes:
measure: plasma resolvin E1, cell-mediated immunity
timeFrame: 30 days
Secondary outcomes:
measure: infectious complication rate
timeFrame: 30 days
Other outcomes:
Locations:
city: Chiba
country: Japan
facility: Chiba University Hospital
Study officials:
affiliation: Chiba University
name: Katsunori Furukawa, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT02888210: A Study Assessing Safety and Efficacy of MD-15 Intraocular Lens in Patients With Aphakic Eye After Cataract Surgery
Official title: Open Label, Phase/3 Study Assessing Safety and Efficacy of MD-15 Intraocular Lens in Patients With Aphakic Eye After Cataract Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Cataract
Lead sponsor: Santen Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2016-09-02
Enrollment: 110
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To evaluate safety and efficacy of MD-15 intraocular lens implanted into the aphakic eyes


Eligibility criteria: Inclusion Criteria:

* Patients who intend to undergo phacoemulsification cataract extraction

Exclusion Criteria:

* Patients who undergo secondary implantation
* Patients with vision loss induced by causes other than cataract
* Patients who the principal investigator/subinvestigator considers ineligible for enrollment

Primary outcomes:
measure: Corrected visual acuity
timeFrame: Week 52
Secondary outcomes:
Other outcomes:
Locations:
city: Tokyo
country: Japan
Study officials:
References:
Clinical trial NCT01694810: Cutaneous Tolerability and Safety of NVN1000 Topical Gel in Healthy Volunteers
Official title: A Phase 1 Multiple Dose, Single-Center, Observer-Blind Parallel Group Study Evaluating Safety and Cutaneous Tolerability of NVN1000 Topical Gel in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Acne Vulgaris
Keywords: acne vulgaris
Lead sponsor: Novan, Inc.
Sponsor class: INDUSTRY
First posted: 2012-09-27
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study will assess safety and tolerability of different doses of topical gel containing a new chemical entity, NVN1000, and the vehicle (gel without drug) applied to the face of healthy volunteers with high counts of Propionibacterium acnes. The test product will be applied once daily for 4 weeks. Exploratory measures include whether the topical product decreases the amount of a bacteria associated with acne (P. acnes).

Detailed description: This is a single center, observer blinded, randomized, multiple dose study with 3 doses of NVN1000 and vehicle applied once daily for 4 weeks. There are 4 arms to the study (3 active and 1 vehicle).

Eligibility criteria: Inclusion Criteria:

* Healthy male and female volunteers
* Age 18 or older
* High degree of fluorescence of facial skin under Wood's lamp

Exclusion Criteria:

* Acute or chronic skin disorders
* Use of topical or systemic antibiotics within 4 weeks of study
* Concomitant use of nitroglycerin or other nitric oxide donor drugs
* Females who are pregnant, planning pregnancy or breast feeding

Primary outcomes:
measure: Cutaneous tolerability Evaluation
timeFrame: 4 weeks
Secondary outcomes:
measure: Safety Assessment
timeFrame: 4 weeks
measure: Safety Assessment
timeFrame: 4 weeks
measure: Safety Assessment
timeFrame: 4 weeks
measure: Safety Assessment
timeFrame: 4 weeks
measure: Safety Assessment
timeFrame: 4 weeks
measure: Safety Assessment
timeFrame: 4 weeks
measure: Safety Assessment
timeFrame: 4 weeks
measure: Safety Assessment
timeFrame: 4 weeks
measure: Safety Assessment
timeFrame: 4 weeks
measure: Safety Assessment
timeFrame: 4 weeks
measure: Safety Assessment
timeFrame: 4 weeks
measure: Safety Assessment
timeFrame: 4 weeks
measure: Safety Assessment
timeFrame: 4 weeks
measure: Safety Assessment
timeFrame: 4 weeks
measure: Safety Assessment
timeFrame: 4 weeks
measure: Safety Assessment
timeFrame: 4 weeks
measure: Safety Assessment
timeFrame: 4 weeks
measure: Safety Assessment
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Broomall
country: United States
facility: KGL, Inc
state: Pennsylvania
Study officials:
affiliation: KGL, Inc.
name: James J Leyden, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02066610: Effect of Selenium Supplementation on Trace Mineral Antioxidant Enzyme and Amino Acid Metabolism in Infants
Official title: Effect of Parenteral and Enteral Selenium Supplementation on Trace Mineral Antioxidant Enzyme and Amino Acid Metabolism in Low Birth Weight Infants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Preterm Infants
Lead sponsor: Abbott Nutrition
Sponsor class: INDUSTRY
First posted: 2014-02-19
Enrollment: 47
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: The objectives of the study were to assess the serum selenium, zinc, and copper status and plasma and white blood cell antioxidant enzyme activities of low birth weight infants receiving selenium supplemented and non-selenium supplemented parenteral nutrition from initiation of parenteral nutrition until discontinuation of preterm formula or hospital discharge.


Eligibility criteria: Inclusion Criteria:

* Weight less than 1500 g at birth
* Not capable of receiving enteral feedings prior to 7 days postnatally

Exclusion Criteria:

* Metabolic abnormalities such as inborn errors of metabolism
* Current viral infections
* Enterocolitis confirmed by diagnosis
* Presence of congenital anomalies, severe cardiac disease, liver disease, severe renal and neurological diseases, cholestasis, hemolytic disease and severe gastrointestinal disease
* Evidence of chronic white blood cell disease

Primary outcomes:
measure: Serum Selenium
timeFrame: Change from Baseline to Discharge (~50-60 days)
Secondary outcomes:
measure: Weight
timeFrame: Change from study day 1 to study exit (~50-60 days)
measure: Length
timeFrame: Change from study day 1 to study exit (~50-60 days)
measure: Head Circumference
timeFrame: Change from study day 1 to study exit (~50-60 days)
measure: Intake
timeFrame: Change from study day 1 to study exit (~50-60 days)
measure: Serum Copper
timeFrame: Change from Baseline to Discharge (~50-60 days)
measure: Serum Zinc
timeFrame: Change from Baseline to Discharge (~50-60 days)
measure: WBC Super oxide dismutase (SOD) activity
timeFrame: Change from Baseline to Discharge (~50-60 days)
measure: Glutathione peroxidase (GSHpx) activity
timeFrame: Change from Baseline to Discharge (~50-60 days)
measure: Plasma GSHpx activity
timeFrame: Change from Baseline to Discharge (~50-60 days)
measure: Plasma Amino Acid Concentrations
timeFrame: Change from Baseline to Discharge (~50-60 days)
Other outcomes:
Locations:
city: Portland
country: United States
facility: Legacy Emanuel Children's Hospital
state: Oregon
Study officials:
affiliation: Abbott Nutrition
name: Marlene Borschel, Ph.D
role: STUDY_CHAIR
References:
Clinical trial NCT03834610: Daily Oral L-arginine Plus Tadalafil in Diabetic Patients With Erectile Dysfunction
Official title: Daily Oral L-arginine Plus Tadalafil in Diabetic Patients With Erectile Dysfunction: A Double-blinded Randomized Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Erectile Dysfunction
Keywords: Erectile dysfunction
Diabetes
Tadaladil
L-arginine
Lead sponsor: Aswan University Hospital
Sponsor class: OTHER
First posted: 2019-02-08
Enrollment: 108
Sex: MALE
Minimum age (years): 35
Maximum age (years): 56
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Tadalafil is an effective oral therapy in erectile dysfunction. L-arginine is a pro drug that increase the level of nitrous oxide in the smooth muscles so can increase the strength and duration of erection. this clinical trials compare the daily oral L-arginine plus tadalafil in treatment of erectile dysfunction in diabetic patients.


Eligibility criteria: Inclusion Criteria:

* patients with type 2 DM

Exclusion Criteria:

* Patients with history of pelvic trauma, major pelvic surgical intervention, hypogonadism, hyperprolactinemia, hypertension, chronic prostatitis, chronic liver disease, smokers, history of chronic intake of CNS or anti-androgen drugs and patients with Peyronie's Disease or any fibrotic anomalies

Primary outcomes:
measure: International Index of Erectile Function score (IIEF-5) improvement after treatment. IIEF-5 score of 22-25: No erectile dysfunction (ED), 17-21: Mild ED, 12-16: Mild to moderate ED, 8-11: Moderate ED, 5-7: Severe ED.
timeFrame: 8 weeks of treatment
measure: Increase in Serum Total testosterone level in (nmol/L) after treatment.
timeFrame: 8 weeks of treatment
measure: Improvement in Penile Doppler parameters after treatment including peak systolic velocity in (cm/sec), end diastolic volume in (cm/sec) and resistive index (RI) that = (peak systolic velocity - end diastolic velocity ) / peak systolic velocity.
timeFrame: 8 weeks of treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Aswan
country: Egypt
facility: Aswan University Hospital
Study officials:
affiliation: Aswan University Hospital
name: Moustafa M El Taieb, MD
role: PRINCIPAL_INVESTIGATOR
References: