louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00454506: Hospital for Special Surgery Hip Arthroplasty Cohort
Official title: Prospective Evaluation of the Clinical and Economic Outcomes of Total Joint Replacement: HSS Hip Arthroplasty Cohort
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Hip Arthroplasty
Lead sponsor: Hospital for Special Surgery, New York
Sponsor class: OTHER
Collaborators: name: Agency for Healthcare Research and Quality (AHRQ)
First posted: 2007-03-30
Enrollment: 3000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: We will be asking all patients undergoing a total hip arthroplasty to participate.

Brief summary: Total joint replacements are some of the most successful medical devices developed over the last fifty years. They enable millions of people to remain ambulatory and pain free, with minimal risk. In 2002, over 200,000 total hip replacements, 350,000 total knee replacements, and 25,000 total or partial shoulder replacements were performed in the United States (HCUP data). Future use will likely be even higher: it is estimated that by the year 2020, the population 65 and over in developed countries will increase by 71%. Existing studies do not provide adequate prospective data to evaluate long-term outcomes. Most health related quality of life studies in THA and TKA only report data up to twelve months post-operatively. In addition, most large studies of TKA and THA have been performed in Medicare patients. While these databases are important in providing population based data, Medicare studies do not permit any direct patient contact, and provide no information on patients under 65.

Existing studies have also investigated predictors of patient outcome at one and two years after joint arthroplasty. However, very little is known about predictors of prosthesis failure, and there are no validated clinical indicators for choosing one prosthesis model over another. Once a device is FDA approved, there is very little motivation on the part of the developer to perform complete post-marketing research, despite the importance of these data to the public health. Most existent studies are not powered to compare differences between models.

The purpose of this study is to establish a prospective cohort of HSS total hip arthroplasty.


Eligibility criteria: Inclusion Criteria:

* 18 years or older
* Undergoing total knee arthroplasty at HSS
* Pregnant women are eligible for the registry as this is a non-interventional study which only involves filling out questionnaires.

Exclusion Criteria:

* No other exclusion criteria;this is a non-interventional study which only involves filling out questionnaires.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Hospital for Special Surgery
state: New York
Study officials:
affiliation: Hospital for Special Surgery, New York
name: Thomas P Sculco, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06387706: The Development of a Gamified Web-based Pain Management Program (GAP) for Community-dwelling Older Adults With Chronic Pain
Official title: The Development of a Gamified Web-based Pain Management Program (GAP) for Community-dwelling Older Adults With Chronic Pain
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Chronic Pain Syndrome
Lead sponsor: The Hong Kong Polytechnic University
Sponsor class: OTHER
First posted: 2024-04-29
Enrollment: 4
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: Pain Management in Older Adults: Pain significantly impacts the well-being of older adults, often leading to diminished physical abilities and a reduced quality of life. Despite this, pain management remains suboptimal, with concerns about medication side effects and a tendency to view pain as a natural aspect of aging. Consequently, many seniors are hesitant to use painkillers. As an alternative, non-pharmacological strategies such as educational programs, physical activity, massage, relaxation techniques, and music therapy are gaining traction.

Innovative Non-Drug Solutions: To improve participation in non-medication pain relief methods, we suggest incorporating gaming elements into these programs (GAP). Originating in digital media in 2008, gamification has since spread across various industries. It involves adding game-like elements to activities to boost engagement, experience, and motivation.

Project Goals: The aims of this initiative include creating a web-based Gamified Pain Management Program (GAP), engaging older adults with chronic pain in the development of GAP, and gathering their feedback on the program's effectiveness.


Eligibility criteria: Inclusion Criteria:

* Aged 60 or above
* Can understand Cantonese
* Scored \>6 in the Abbreviated Mental Test; a cut-off point of 6 is valid for differentiating between normal and abnormal cognitive functions in geriatric clients
* Have a history of non-cancer pain in the past 6 months
* Have a pain score of at least 2 on the Numeric Rating Scale
* Able to take part in light exercise and stretching
* Owns a smartphone and can access the Internet

Exclusion Criteria:

* Have severe visual and/or auditory deficits that affect that seeing and hearing
* Have a serious organic disease or malignant tumor
* Have a mental disorder diagnosed by neurologists or psychiatrists
* Had a surgical treatment in the past two months
* Experienced drug addiction

Primary outcomes:
measure: Pain Relief
timeFrame: 4-week
Secondary outcomes:
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Hong Kong Metropolitan University
Study officials:
References:
Clinical trial NCT03454906: Factors Influencing Hemoglobin Variability and Its Association With Mortality in Hemodialysis Patients
Official title: Baskent University Nephrology Department
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hemodialysis-Induced Symptom
Keywords: hemodialysis
hemoglobin variability
mortality
nutrition
inflammation
Lead sponsor: Baskent University
Sponsor class: OTHER
First posted: 2018-03-06
Enrollment: 169
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: -one hundred and sixty nine patient that receive chronic hemodialysis treatment in Baskent university hospital were enrolled to the study.

Brief summary: The aim of the study is to investigate the factors influencing hemoglobin variability with inflammatory and nutritional parameters and its associations with all-cause mortality among hemodialysis patients.

Detailed description: Fluctuation in hemoglobin levels that is known as hemoglobin variability during treatment with ESA is a well-documented phenomenon. Several factors have been found to affect hemoglobin variability, including drug related, such as pharmacokinetic parameters, patient-related differences in demographic characteristics and factors affecting clinical status, as well as clinical practice guidelines, treatment protocols and reimbursement policies. Inflammation is also an important factor associated with hemoglobin variability, and the consequences of persistent inflammatory activity are far-reaching in affected patients.

In present study, the factors influencing hemoglobin variability with inflammatory and nutritional parameters and its associations with all-cause mortality among hemodialysis patients are investigated.

Eligibility criteria: Inclusion Criteria:

* Age \>18
* on chronic hemodialysis treatment

Exclusion Criteria:

* All patients had a minimum of six hemoglobin measurements within a 6- month period, and they were excluded if they received a kidney transplant during this period or those who had blood transfusions during the baseline period.
* Patients with serum ferritin\<100 μg/L were also excluded from the study because of reimbursement of our country.

Primary outcomes:
measure: Factors Influencing Hemoglobin Variability and Its Association with Mortality in Hemodialysis Patients
timeFrame: six month
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Bal Z, Demirci BG, Karakose S, Tutal E, Erkmen Uyar M, Acar NO, Sezer S. Factors Influencing Hemoglobin Variability and Its Association with Mortality in Hemodialysis Patients. ScientificWorldJournal. 2018 Apr 1;2018:8065691. doi: 10.1155/2018/8065691. eCollection 2018.
Clinical trial NCT05632406: Breathing & Blood Pressure
Official title: Breathing & Blood Pressure
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Healthy
Overweight and Obesity
Lead sponsor: Florida State University
Sponsor class: OTHER
First posted: 2022-11-30
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Individuals living in, or near, Tallahassee, FL, USA

Brief summary: The purpose of this study is to determine the effect of obesity on cardiovascular responses during various breathing maneuvers.

Detailed description: Adults with higher body mass can have trouble breathing during exercise, which could be due to high respiratory muscle workloads. These breathing muscles can require a lot of energy, which takes away energy from other (e.g., leg) muscles. Participating in this study will help us understand how the heart and blood vessels respond during brief exercise and during various breathing maneuvers.

Eligibility criteria: Inclusion Criteria:

• Body mass index values of ≤40 kg/m\^2

Exclusion Criteria:

* Not weight stable (\<5% change in body mass over the past six months)
* Overt cardiovascular, neurological, renal, liver, and/or metabolic illness (e.g., diabetes mellitus)
* Current, or history of uncontrolled, Stage 2 hypertension (blood pressure \>140 / 90 mmHg; anti-hypertensive medications are permitted)
* Diagnosed obstructive sleep apnea
* Previous bariatric surgery
* Diagnosis or signs (e.g., values below the lower limit of normal) of overt airway disease(s)
* Current or recent (regular use within the past 6 months) use of tobacco or nicotine products (e.g., cigarettes, vaping)
* Per the POWERbreathe® company:
* Patients who have undergone recent abdominal surgery and those with abdominal hernia.
* Asthma patients who have a very low symptom perception and suffer from frequent, severe exacerbations or with an abnormally low perception of dyspnoea.
* If a patient is suffering from a ruptured eardrum or any other condition of the ear.
* Patients with marked elevated left ventricular end-diastolic volume and pressure.
* Patients with worsening heart failure signs and symptoms after a respiratory/inspiratory muscle training (IMT) session
* If you are suffering from a cold, sinusitis, or respiratory tract infection, we advise that you do not use your POWERbreathe IMT device.
* Individuals who are not yet adults (infants, children, teenagers)
* Pregnant (self-reported and urine pregnancy test conducted), lactating (self-reported), or post-menopausal (self-reported) females
* Prisoners

Primary outcomes:
measure: Blood pressure during exercise
timeFrame: Up to one week
Secondary outcomes:
measure: Blood pressure during respiratory muscle testing
timeFrame: Up to one week
Other outcomes:
Locations:
city: Tallahassee
country: United States
facility: Florida State University
state: Florida
Study officials:
affiliation: Florida State University
name: Joseph Watso, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01519206: Lifting and Tightening of the Face and Neck Following an Increased Density Treatment
Official title: Evaluation of the Efficacy and Safety of the Ulthera® System for Lifting and Tightening of the Face and Neck Following an Increased Density Treatment.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Skin Laxity
Keywords: Ulthera® System
Ultherapy™ Treatment
Ulthera, Inc.
Lead sponsor: Merz North America, Inc.
Sponsor class: INDUSTRY
First posted: 2012-01-26
Enrollment: 32
Sex: ALL
Minimum age (years): 30
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the Ulthera® System for obtaining lift and tightening of the cheek tissue, reduction of jowling, and improving jawline definition and/or submental skin laxity when increased density treatment is applied.

Detailed description: All enrolled study subjects will receive one full face and neck Ultherapy™ treatment. Pre- and post-treatment photos will be taken. Subjects will be required to return for follow-up visits at 60 days, 90 days, 180 days and 1 year following treatment.

Eligibility criteria: Inclusion Criteria:

* Male or female, aged 30 to 65 years
* Subject in good health
* Desires lift and tightening of cheek tissue, reduction of jowling, improvement of jawline definition and/or submental skin laxity
* Understands and accepts the obligation not to undergo any other procedures in the areas to be treated through the followup period
* Willingness and ability to comply with protocol requirements, including returning for follow-up visits and abstaining from exclusionary procedures for the duration of the study

Exclusion Criteria:

* Presence of an active systemic or local skin disease that may affect wound healing
* Severe solar elastosis
* Excessive subcutaneous fat on the cheeks
* Excessive skin laxity on the lower face and neck
* Significant scarring in areas to be treated
* Significant open facial wounds or lesions
* Severe or cystic acne on the face
* Presence of a metal stent or implant in the facial area to be treated, a pacemaker, or cochlear implants

Primary outcomes:
measure: Improvement in Overall Lifting and Tightening of Skin
timeFrame: Baseline to 90 days post treatment
Secondary outcomes:
measure: Overall Aesthetic Improvement at 60 Days, 90 Days, 180 Days and 1 Year Post-treatment.
timeFrame: Baseline to 60 days, 90 days, 180 days and 1 year post-treatment
measure: Subjects' Assessment of Pain
timeFrame: During Ulthera treatment
measure: Subject Satisfaction at 90 Days, 180 Days and 1 Year Post-treatment
timeFrame: Baseline to 90 days, 180 days and 1 year post-treatment
Other outcomes:
Locations:
city: New York
country: United States
facility: Laser & Skin Surgery Center of NY
state: New York
Study officials:
affiliation: Laser & Skin Surgery Center of NY
name: Roy Geronemus, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02186106: Dosage Calculation for Vitamin D Treatment
Official title: The Effect of Oral Loading Doses of Cholecalciferol on the Serum Concentration of 25-OH-vitamin-D
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Deficiency, Vitamin D
Obesity
Lead sponsor: Bispebjerg Hospital
Sponsor class: OTHER
First posted: 2014-07-10
Enrollment: 31
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Severe vitamin D deficiency can be treated with oral loading doses of cholecalciferol. Our objective was to determine how to calculate the quantity of cholecalciferol needed for supplementation by single algorithm, usable on a patient-to-patient basis.

We've conducted two studies. Study 1 was done retroactively and included 88 patients treated for low vitamin D, 60 of those with a loading dose. The second study included 29 patients and aimed to test the validity of an algorithm based on data from study 1, which included patient BMI. Both studies used oral loading doses and daily supplementation of cholecalciferol.


Eligibility criteria: Inclusion Criteria:

* severe hypovitaminosis D (25OH-vit.D \<25 nmol/L)

Exclusion Criteria:

* Malabsorption
* Renal disease
* Other treatment with vitamin D related products
* Patients with a recent travel history with suspected increased sun exposure

Primary outcomes:
measure: Change in baseline value of [25-OH-vitamin-D]
timeFrame: 1 week, 3 weeks and 3 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02156206: Impact Evaluation of the 123 Women Emergency Phone Line in Medellín, Colombia
Official title: Building Capacity of State and Local Actors to Respond to Violence Against Women: Impact Evaluation of the 123 Women Emergency Phone Line in Medellín (Colombia), Component of the Program "Seguridad Pública".
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Violence Against Women (VAW)
Lead sponsor: Econometría Consultores
Sponsor class: OTHER
Collaborators: name: Inter-American Development Bank
First posted: 2014-06-05
Enrollment: 765
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Women that call the 123 emergency line in Medellín, Colombia

Brief summary: The purpose of this study is to determine whether the 123 women emergency phone line of Medellin (Colombia) leads to a reduction in the violence suffered by women, as well as in their psychological wellbeing and attitudes towards violence.

Detailed description: The purpose of this study is to determine whether the 123 women emergency phone line of Medellin (Colombia) leads to a reduction in the violence suffered by women, as well as in their psychological wellbeing and attitudes towards violence.

There is excess demand for the 123 women emergency phone line of Medellin. While on average 10 cases are reported (excluding referrals at night by the police, between 7pm and 7:00 a.m.), the average daily capacity of operation is 6 cases. So, is not possible for the 123 women team to track all women who call in 24 hours. Women who cannot receive the services of the 123 women team only get the emergency support of the police and do not receive additional aid (while it is verified that the rights of women are respected and they are guided to relevant services). The excess of demand over the capacity of the team of the 123 women line represents a natural experiment.

Women will be recruited from those who are attended by the 123 emergency women phone line immediately as well as from those who were only attended by emergency support of the police and may have received later the support of the 123 women line (control group). In a first instance, women will be called to verify their address. A face to face survey will be conducted by mid-2015.

Eligibility criteria: Inclusion Criteria:

* Women that call the 123 emergency line

Exclusion Criteria:

-

Primary outcomes:
measure: Occurrence of violence
timeFrame: 3 months
Secondary outcomes:
measure: Knowledge, attitudes and practices (KAP) on violence and care pathways
timeFrame: Average of 6 months after calling the 123 emergency line
measure: Psychological well-being (self-acceptance, positive relationships, autonomy, environmental mastery, personal growth, purpose in life)
timeFrame: Average of 6 months after calling the 123 emergency line
measure: Formal complaints
timeFrame: 3 months
Other outcomes:
Locations:
city: Bogota
country: Colombia
facility: Econometria Consultores
Study officials:
References:
Clinical trial NCT00198406: A FRENCH SURVEY OF THE DIAGNOSTIC AND THERAPEUTIC MANAGEMENT OF ELDERLY PEOPLE WITH HISTOLOGICALLY/CYTOLOGICALLY CONFIRMED LUNG CANCER.
Official title: A FRENCH SURVEY OF THE DIAGNOSTIC AND THERAPEUTIC MANAGEMENT OF ELDERLY PEOPLE WITH HISTOLOGICALLY/CYTOLOGICALLY CONFIRMED LUNG CANCER.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: ELDERLY PEOPLE
Non-small Cell Lung Cancer
Lead sponsor: Intergroupe Francophone de Cancerologie Thoracique
Sponsor class: OTHER
First posted: 2005-09-20
Enrollment: 1653
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE

Brief summary: Management of lung cancer remains very controversial for elderly patients (pts) and they are often excluded from clinical trials. We present here a survey performed about the management of lung cancer pts aged 70 or more in France. All pts aged 70 or more with histo/cytologically proved lung cancer diagnosed between sept 02 and oct 03 in participating centers were recorded and their characteristics, the diagnostic procedures, therapeutic management and survival were analysed.


Eligibility criteria: Inclusion Criteria:

* histo/cytologically proved lung cancer

Exclusion Criteria:

-

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: CHU Lyautey - Pneumologie
Study officials:
affiliation: Intergroupe Francophone de Cancerologie Thoracique
name: Elisabeth Quoix
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04709406: Determinants on Rocuronium Dose for Deep Block in Bariatric Surgery
Official title: Analysis of Determinants on the Dose of Rocuronium for Deep Neuromuscular Blockade in Bariatric Surgery.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Bariatric Surgery
Keywords: bariatric surgery
deep neuromuscular blockade
Lead sponsor: Seoul National University Bundang Hospital
Sponsor class: OTHER
First posted: 2021-01-14
Enrollment: 90
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: obese patients who scheduled bariatric surgery

Brief summary: Find out the deciding factor(total body weight, corrected body weight, ideal body weight, fat-free mass, body mass index, skeletal muscle mass, body fat) of neuromuscular blocker dose for deep neuromuscular blockade in bariatric surgery.

Detailed description: Before the surgery, total body weight, corrected body weight, ideal body weight, fat-free mass, body mass index were measured by height and weight and skeletal muscle mass and body fat were measured by Bioelectrical impedance analysis (InbodyH20B). Find the highest correlation between the 8 factors (total body weight, corrected body weight, ideal body weight, fat-free mass, body mass index, skeletal muscle mass, body fat) and the amount of rocuronium administered to deep neuromuscular blockade in bariatric surgery.

Eligibility criteria: Inclusion Criteria:

* Patients aged 20-80 and American Society of Anesthesiology Physical Grade (ASA) I-II, who undergo bariatric surgery

Exclusion Criteria:

* kidney disease (GFR\<60)
* allergy to study drugs
* decline participation
* side effect of propofol and remifentanil
* when anesthesia does not maintain the level of alertness (BIS) below 60 even when the anesthetic dose is increased, or when hemodynamic instability such as bradycardia and hypotension appears

Primary outcomes:
measure: the highest correlation coefficient
timeFrame: preoperative 1 days to postoperative 1 days
Secondary outcomes:
measure: onset time of rocuronium
timeFrame: preoperative 1 days to postoperative 1 days
measure: time to deep neuromuscular blockade
timeFrame: preoperative 1 days to postoperative 1 days
measure: Recovery time
timeFrame: preoperative 1 days to postoperative 1 days
Other outcomes:
Locations:
Study officials:
References:
citation: Choi YJ, Hee Kim Y, Bae GE, Yu JH, Yoon SZ, Kang HW, Lee KS, Kim JH, Lee YS. Relationship between the muscle relaxation effect and body muscle mass measured using bioelectrical impedance analysis: A nonrandomized controlled trial. J Int Med Res. 2019 Apr;47(4):1521-1532. doi: 10.1177/0300060518822197. Epub 2019 Feb 5.