louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02237963: Influence of the Surgical Approach on the Development of a Chronic Pain After Thoracic Surgery
Official title: Influence of the Surgical Approach on the Development of a Chronic Pain After Thoracic Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pain, Postoperative
Lead sponsor: Hopital Foch
Sponsor class: OTHER
First posted: 2014-09-12
Enrollment: 209
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: Patients undergoing thoracic surgery by posterolateral or axillary thoracotomy, having no exclusion criteria for the study,

Brief summary: The prevalence of chronic pain after a thoracotomy is around 48 %. This research focuses on the surgical approach. The posterolateral approach is compared to the axillary approach especially in term of development of a chronic pain.


Eligibility criteria: Inclusion Criteria:

* patients undergoing thoracic surgery intervention by posterolateral or axillary thoracotomy, having no exclusion criteria for the study,

Exclusion Criteria:

* planned surgery by thoracoscopy or extended surgery,
* mental disability,
* vulnerable person within the meaning of French law,
* inability to communicate by phone,
* poor understanding of French.

Primary outcomes:
measure: Chronic pain
timeFrame: 4 months
Secondary outcomes:
measure: Early postoperative pain
timeFrame: 7 days
measure: Characteristics of chronic pain
timeFrame: 4 months
measure: Quality of life
timeFrame: 4 months
measure: Catastrophism
timeFrame: 4 months
measure: Anxiety
timeFrame: 4 months
measure: Preventive role of epidural analgesia
timeFrame: 4 months
Other outcomes:
Locations:
city: Suresnes
country: France
facility: Hopital Foch
Study officials:
affiliation: Hôpital Foch
name: Mireille Michel-Cherqui, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ringsted TK, Wildgaard K, Kreiner S, Kehlet H. Pain-related impairment of daily activities after thoracic surgery: a questionnaire validation. Clin J Pain. 2013 Sep;29(9):791-9. doi: 10.1097/AJP.0b013e318278d4e2.
Clinical trial NCT03352063: Prolonged Sitting on Responses to Short-Term Exercise Training
Official title: Effect of Prolonged Sitting on Metabolic and Cardiovascular Responses to Short-Term Exercise Training
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Atherosclerosis
Metabolic Syndrome
Lead sponsor: University of Texas at Austin
Sponsor class: OTHER
First posted: 2017-11-24
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Subjects will be randomly assigned to either the sitting plus exercise or walking plus exercise.
Primary purpose: PREVENTION

Brief summary: Prolonged sitting has been shown to effect the response to a high fat tolerance test (HFTT) after acute exercise. This study will evaluate the effect of prolonged sitting on response to a HFTT after a short term training period.


Eligibility criteria: Inclusion Criteria:

* 18 to 35 years

Exclusion Criteria:

* cardiovascular problems (e.g. pre-existing heart issues, coronary artery disease, hypertension, etc.)
* respiratory problems
* musculoskeletal problems that prevent prolonged sitting or exercise
* obesity
* susceptibility to fainting
* pregnancy

Primary outcomes:
measure: Plasma Triglycerides
timeFrame: 6 hours
Secondary outcomes:
measure: Plasma Insulin
timeFrame: 6 hours
measure: Plasma glucose
timeFrame: 6 hours
Other outcomes:
Locations:
city: Austin
country: United States
facility: University of Texas at Austin Human Performance Laboratory
state: Texas
Study officials:
References:
citation: Burton HM, Wolfe AS, Vardarli E, Satiroglu R, Coyle EF. Background Inactivity Blunts Metabolic Adaptations to Intense Short-Term Training. Med Sci Sports Exerc. 2021 Sep 1;53(9):1937-1944. doi: 10.1249/MSS.0000000000002646.
Clinical trial NCT06414863: Effects of Invisalign Palatal Expander System
Official title: Treatment Effects of Invisalign Palatal Expander System and Hyrax Palatal Expander - A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Palatal Expansion Technique
Lead sponsor: University of the Pacific
Sponsor class: OTHER
First posted: 2024-05-16
Enrollment: 120
Sex: ALL
Minimum age (years): 6
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is to evaluate the effectiveness of Invisalign Palatal Expander system ingrowing patients. This study compares the treatment outcomes of Invisalign Palatal Expander system to conventional treatments through randomized controlled trial.


Eligibility criteria: Inclusion criteria:

1. Mixed dentition phase with at least three nonmobile (stable) teeth which have more than 1/4 of primary molar root length left16 in either side
2. Early permanent dentition stage and early permanent dentition but second permanent molars not yet fully erupted in the arch
3. Unilateral or bilateral posterior cross bite patients; or Patients who have been diagnosed with transverse maxillary deficiency (Skeletal transverse discrepancy measured from the estimated center of resistances of the first molars17 ≤ - 3 mm);
4. Patients with Class I or Class II skeletal relationship
5. Subjects willing to consent to the trial

Exclusion Criteria:

1. Any general medical health problems which may influence treatment
2. Any craniofacial anomalies
3. Skeletal Class III patients
4. Mixed dentition patients with more than 2 heavily restored primary second or permanent first molars.

Primary outcomes:
measure: Width change
timeFrame: 12-18 months
measure: Arch width change
timeFrame: 12-18 months
Secondary outcomes:
measure: Cephalometric changes
timeFrame: 12-18 months
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: University of the Pacific
state: California
Study officials:
affiliation: University of the Pacific
name: Heeyeon Suh
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04442763: The Effect of Osseodensification on Implant Stability in Posterior Maxilla
Official title: Assessment of Dental Implants Stability After Using Osseodensification Method Versus Conventional Drilling in the Posterior Maxilla: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Implant Stability
Keywords: Osseodensification
Densah burs
conventional drilling
implant stability
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2020-06-23
Enrollment: 20
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: Implants will be placed in posterior maxilla using two drilling methods; the osseodensification technique and conventional drilling protocols. Implant stability will be measured after implant placement , 1,2,3,4,6 and 8 weeks and 3 months later. Insertion torque will be evaluated at the termination of implant placement and crestal bone loss will be measured post-implant insertion, after 3 months and after 6 and 12 months of loading. Post-operative pain and patients' satisfaction will be assessed as well. implant survival will be assessed at the end of the follow up period


Eligibility criteria: Inclusion Criteria:

* Age: \>18 years; medically free,
* Partially edentulous patients in maxillary posterior area (premolar-molar area)
* Sufficient ridge height
* Sufficient ridge width
* Adequate soft tissue biotype.
* Patients with adequate inter-arch space for placement of implant prosthetic part.
* Cooperative patients with good oral hygiene
* Patients who accept to sign an informed consent.

Exclusion Criteria:

* Active periodontal diseases
* Parafunctional habits.
* History of radiation therapy to the head and neck
* Bone augmentation to implant site
* Smoking
* Pregnant females

Primary outcomes:
measure: Implant stability
timeFrame: immediately post-implant insertion, 1,2,3,4,6,8 weeks and 3 months
Secondary outcomes:
measure: Crestal bone loss
timeFrame: immediately post-implant insertion - 3 months- 6 and 12 months post-loading
measure: Insertion torque
timeFrame: at the termination of implant insertion
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Cairo University
Study officials:
affiliation: Professor, Faculty of Dentistry, Cairo University
name: Omnia Aboul Dahab
role: STUDY_DIRECTOR
References:
Clinical trial NCT06452563: Amino Acids Supplementation and Exercise Intervention in Hemodialysis Patients
Official title: Amino Acids Supplementation and Exercise Intervention in Hemodialysis Patients: Effects on Muscle and Fatigue - a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE4
Conditions: Hemodialysis Complication
Malnutrition
Keywords: haemodialysis patients
ketoanalogs
malnutrition
exercise
Muscle function
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2024-06-11
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The goal of this randomized clinical trial is to observe the effect of Amino acids (AAs)supplementation and exercises in haemodialysis patients . The main question it aims to answer is :

Does AAs supplementation and regular exercises have an effect on the muscle mass and function in haemodialysis patients ? Participants will receive daily a total of six tablets of amino acids supplementation divided into three doses. And some Participants will also be asked to do intradialytic exercise.

Researchers will compare the effects of these interventions on the muscle mass and fatigue, among four groups:

1. A group that will be only taking AAs supplementation
2. A group taking AAs supplementation along with intradialytic exercise
3. A group only performing intradialytic exercise
4. A passive control group This will be monitored through BMI, anthropometric measures, Musculoskeletal ultrasound assessment of the quadriceps muscle , fatigue questionnaires and sit and stand test.


Eligibility criteria: Inclusion Criteria:

* Hemodialysis patients due to chronic kidney diseases
* Age between 18 - 60

Exclusion Criteria:

* Frail patients
* The patients who refused to participate
* Growth retarded patients
* Disabilities

Primary outcomes:
measure: Muscle mass
timeFrame: 3 months
measure: Muscle function test
timeFrame: 3 months
measure: The thickness of the quadriceps rectus femoris and quadriceps vastus intermedius
timeFrame: 3 months
Secondary outcomes:
measure: Fatigue score
timeFrame: 3 months
Other outcomes:
Locations:
city: El Mansura
country: Egypt
facility: Mansoura University
Study officials:
References:
Clinical trial NCT01963663: Metformin and Pioglitazone Effects on YKL-40 Concentrations in Type 2 Diabetes Patients
Official title: Comparison of Metformin and Pioglitazone Effects on Serum YKL-40 Concentrations in Patients With Newly Diagnosed Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 2 Diabetes Mellitus
Keywords: YKL-40
Chronic low grade inflammation
type 2 diabetes mellitus
metformin
pioglitazone
Lead sponsor: Tehran University of Medical Sciences
Sponsor class: OTHER
First posted: 2013-10-16
Enrollment: 84
Sex: ALL
Minimum age (years): 35
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: Patients with type 2 diabetes are at an increased risk for developing atherosclerosis, largely due to the underlying insulin resistance and chronic low grade inflammation. Cardiovascular events could be prevented with proper interventions targeted at ameliorating the aforementioned detrimental processes. YKL-40, a novel surrogate marker of acute and chronic inflammatory states has been implicated to have a putative role in both pathways. Given the shared pathway of insulin resistance and atherosclerosis, it is conceivable that anti-diabetes medications are able to modify coronary artery disease risk via direct and indirect amelioration of YKL-40 concentrations. The present clinical trial was therefore launched to examine the comparative effects of metformin and pioglitazone, two commonly prescribed anti-diabetes medications on YKL-40 concentrations in medication-naïve, newly-diagnosed type 2 diabetes patients.


Eligibility criteria: Inclusion Criteria:

* Newly diagnosed type 2 diabetes patients based on American Diabetes Association criteria for diagnosis of diabetes

Exclusion Criteria:

* positive history for taking anti-diabetes medications of any class in the past
* positive current history for taking over-the-counter vitamin or anti-oxidant supplements
* presence of clinically significant chronic illnesses of the heart, lungs, or kidneys.

Primary outcomes:
measure: Serum concentration of YKL-40
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Tehran
country: Iran, Islamic Republic of
facility: Diabetes Clinic, Vali-Asr Hospital, Tehran University of Medical Sciences
Study officials:
affiliation: Tehran University of Medical Sciences
name: Alireza Esteghamati, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Esteghamati A, Azizi R, Ebadi M, Noshad S, Mousavizadeh M, Afarideh M, Nakhjavani M. The comparative effect of pioglitazone and metformin on serum osteoprotegerin, adiponectin and intercellular adhesion molecule concentrations in patients with newly diagnosed type 2 diabetes: a randomized clinical trial. Exp Clin Endocrinol Diabetes. 2015 May;123(5):289-95. doi: 10.1055/s-0034-1396864. Epub 2015 Jan 21.
Clinical trial NCT05077163: Patients With Acute Renal Failure During Severe COVID-19
Official title: Renal Assessment of Patients With Acute Renal Failure During Severe COVID-19
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Renal Failure Chronic
Keywords: COVID-19
SARS-COV-2
Renal failure
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2021-10-14
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: - Major subject hospitalized in an intensive care unit, Strasbourg, Nancy or Reims Hospitals, for severe COVID-19 between February 1, 2020 and July 31, 2020.

Brief summary: The occurrence of renal failure during severe forms of COVID-19 is common (20-35% of patients treated in intensive care) and associated with an unfavorable short-term prognosis, but the medium-term renal outcome is not is not known.

The aim of the study is to establish the frequency of chronic kidney failure after AKI KDIGO 2 and 3 occurring during severe COVID-19 in intensive care.


Eligibility criteria: Inclusion criteria:

* Major subject (≥18 years old)
* Subject hospitalized in an intensive care unit, Strasbourg, Nancy or Reims hospitals, for severe COVID-19 between February 1, 2020 and July 31, 2020.
* Having presented acute renal failure KDIGO 2 (assessed on a doubling of serum creatinine compared to the patient's reference values) or 3 (serum creatinine greater than 3 times the patient's reference, or anuria, or any recourse to extra-purification renal)
* Having left hospital alive after initial treatment for COVID-19
* Subject not having expressed his opposition, after information, to the reuse of his data for the purposes of this research.

Exclusion criteria:

* Subject having expressed opposition to participating in the study
* Subject under guardianship or guardianship
* Subject under safeguard of justice

Primary outcomes:
measure: Retrospective study of renal development in patients with acute renal failure during severe COVID-19
timeFrame: Files analysed retrospectively from February 01, 2020 to July 31, 2020 will be examined]
Secondary outcomes:
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Service de Néphrologie et Transplantation - Hôpitaux Universitaires de Strasbourg
Study officials:
affiliation: Service de Néphrologie et Transplantation - Hôpitaux Universitaires de Strasbourg
name: Bruno MOULIN, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02932163: Predictors of Chronic Non-specific Low Back Pain
Official title: Relationships Between Muscular Impairments, Pain, and Disability in Patients With Chronic Non-specific Low Back Pain: a Cross Sectional Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Low Back Pain
Keywords: Chronic low back pain
disability
endurance
Lead sponsor: Fondazione Don Carlo Gnocchi Onlus
Sponsor class: OTHER
First posted: 2016-10-13
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with chronic non-specific LBP were recruited from five hospitals in Ahvaz, Iran.

Brief summary: Chronic non-specific low back pain (CNSLBP) has been defined as a persistent pain in the lower back for at least three months with no known causes. The CNSLBP prevalence is estimated of 90% among all types of the LBP. The LBP imposes high direct and indirect costs on the patients and the society. Whereas a specific pathology has not been identified for CNSLBP, mechanical factors (e.g. changes in muscle length, strength, or endurance) may contribute to the pain and disability.


Eligibility criteria: Inclusion Criteria:

* Patients with chronic non-specific LBP,
* LBP duration ≥ 6 months.

Exclusion Criteria:

* spinal osteoarthritis,
* spondylolisthesis,
* history of vertebral fractures.

Primary outcomes:
measure: Change of Pain intensity
timeFrame: Baseline
measure: Change of Disability
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: IRCCS Don Gnocchi Foundation
name: JORGE H VILLAFAÑE, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04935463: Mucormycosis in COVID-19
Official title: Mucormycosis in COVID-19
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Covid19
Mucormycosis
Aspergillosis
Candida Infection
Lead sponsor: Montefiore Medical Center
Sponsor class: OTHER
Collaborators: name: Medanta Institute Delhi
name: AIIMS Patna
name: HCG Oncology Bangalore
name: NSCB Jabalpur
First posted: 2021-06-23
Enrollment: 728
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The investigators have a web-based platform to allow physicians or other healthcare providers to report cases of confirmed Mucormycosis in patients with COVID 19. Physician reporters will individually enter de-identified data into a secure, electronic database (REDCap). The case report form will include items requesting the following information: age, country of residence, state of residence(within India), name of center/practice/physician reporting the case, gender, height, weight, patient's history specifics (diabetes, cancer, organ transplant, neutropenia, prior steroid use and intravenous drug use), COVID severity ( mild/moderate/severe), admission CRP values in mg/dL, COVID treatments prescribed, Mucormycosis treatment prescribed and site of mucormycosis( rhinocerebral, pulmonary, cutaneous or gastrointestinal) Once a reporter completes a survey, the reporter will not be able to access the survey again or update it

Brief summary: The purpose is to allow phsyician reporters to contribute to MUNCO registry. Mucormycosis in COVID-19 is a rapidly escalating medical emergency reported in high numbers in India during the ongoing coronavirus surge. There is very little known about the risk factors, patterns and complications of mucormycosis as it occurs either during the infection or treatment phase of the novel coronavirus (COVID-19). In light of this emerging epidemic within a pandemic, it is of time sensitive importance to obtain a better understanding of the risk factors and outcomes of this fatal complication


Eligibility criteria: Inclusion Criteria:

Diagnosed case of Mycotic Infection in COVID-19

Exclusion Criteria:

* None

Primary outcomes:
measure: Vision loss
timeFrame: 60 days
Secondary outcomes:
Other outcomes:
Locations:
city: Bronx
country: United States
facility: Montefiore Medical Center
state: New York
Study officials:
References:
Clinical trial NCT01758263: Economic Impact of Switching From Metoprolol to Nebivolol for Hypertension Treatment
Official title: Economic Impact of Switching From Metoprolol to Nebivolol for Hypertension Treatment: A Retrospective Database Analysis
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Hypertension
Keywords: Hypertension
Health Care Cost
Monthly health care cost
Lead sponsor: Forest Laboratories
Sponsor class: INDUSTRY
First posted: 2013-01-01
Enrollment: 3000
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: Patents treated for hypertension during the period of 2007-2011 in the United States.

Brief summary: This is a retrospective data analysis of patients with high blood pressure (hypertension) who took metoprolol for a minimum of 6 months who then switched to taking nebivolol for a minimum of 6 month to treat hypertension. These patients will be identified from a large medical claims database. This study tests the hypothesis (alternative, higher or lower) that average patient monthly health care administrative cost changes after switching from metoprolol to nebivolol.


Eligibility criteria: Inclusion Criteria:

* Be at least 18 years old at initiation of metoprolol (or first date on metoprolol treatment between 2007 and 2011)
* Had one or more inpatient or outpatient claims with a primary or non-primary diagnosis of hypertension (ICD-9-CM 401.xx-405.xx)
* Received nebivolol treatment continuously (defined as supply gap \<30 days) for at least 6 months after initiation
* Received metoprolol treatment continuously for at least 6 months prior to switching to (initiation of) nebivolol (defined as metoprolol was discontinued whereas a prescription for nebivolol was filled)
* Had at least 12 months of continuous enrollment (as verified using enrollment file): 6 month prior to nebivolol initiation and 6 months following nebivolol initiation.

Primary outcomes:
measure: Patient monthly health care cost
timeFrame: 6 months
Secondary outcomes:
measure: Number of monthly out-patient visits
timeFrame: 6 months
measure: Monthly Emergency Room visits per patient
timeFrame: 6 months
measure: Monthly hospitalizations per patient
timeFrame: 6 months
Other outcomes:
Locations:
city: Jersey City
country: United States
facility: Forest Investigative Site 0
state: New Jersey
Study officials:
affiliation: Forest Laboratories
name: Stephanie Chen, PhD
role: STUDY_DIRECTOR
References: