louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06626607: Different Antihypertensive Drugs on Aortic Diseases
Official title: A Study of the Effect of Different Antihypertensive Drugs on the Disease Progression of Aortic Dissection/Aneurysm
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Aortic Aneurysm
Aortic Dissection
Lead sponsor: Eighth Affiliated Hospital, Sun Yat-sen University
Sponsor class: OTHER
Collaborators: name: Beijing Anzhen Hospital
First posted: 2024-10-04
Enrollment: 704
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: From January 1, 2017 to December 1, 2023, 704 patients with hypertention underwent aortic surgery in the institutions. These patients have complete medical records and follow-up data.

Brief summary: The goal of this observational study is to learn about the effect of different hypotensive drugs on the prognosis of postoperative aortic patients. The main question it aims to answer is:

Does different hypotensive drugs influence the prognosis of postoperative aortic patients? As participants already taking hypotensive drugs as part of their regular medical care, the investigators collect the participants' pre-operation medical record and post-operative follow-up record to evaluate the aorta condition.

Detailed description: This study is a cohort study that aims to explore the effects of different antihypertensive regimens on aortic remodelling in patients after aortic surgery by collecting the hospitalization and outpatient follow-up data. The study plans to gather perioperative and postoperative follow-up data from over 600 patients who underwent aortic surgery at the Eighth Affiliated Hospital and Beijing Anzhen Cardiothoracic Surgery Center. Patients were assigned based on the postoperative antihypertensive medication regimens. Datas was collected to compare the cardiovascular-related prognoses.

This study primarily includes patients who take oral antihypertensive medications after aortic surgery. The main observations will focus on postoperative complications related to the aorta (such as death, reoperation, dilation, etc.) and aortic diameters after the administration of different antihypertensive medications. Multivariate regression analysis will be employed to investigate the impact of different antihypertensive regimens on patients after aortic surgery.

Eligibility criteria: Inclusion Criteria:

* aortic diseases\&#39; patients underwent aortic surgery who require antihypertensive medication.

Exclusion Criteria:

* Patients with active vasculitis;
* Patients allergic to contrast agent
* Patients with aorta variation

Primary outcomes:
measure: Aortic diameter
timeFrame: Through the study completion, on an average of 3 years
Secondary outcomes:
measure: Number of Participants with adverse aortic event
timeFrame: Through the study completion, on an average of 3 years
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02564107: A Study of Ibandronate (Bondronat) in Participants With Metastatic Bone Disease
Official title: An Open Label Study of the Efficacy, Safety, and Pharmacoeconomics of Oral Ibandronate (Bondronat 50 mg) in Treatment of Metastatic Bone Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Pain; Bone Neoplasms; Neoplasm Metastasis
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2015-09-30
Enrollment: 48
Sex: FEMALE
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: This study will evaluate the efficacy, safety, and effect on quality of life of oral ibandronate (Bondronat) in participants with breast cancer and metastatic bone disease. The anticipated time on study treatment is 25 weeks, and the target sample size is 50 individuals.


Eligibility criteria: Inclusion Criteria:

* Females at least 18 years of age
* Breast cancer
* Bone metastases

Exclusion Criteria:

* Use of bisphosphonates within the last 3 months
* Prior use of gallium nitrate or metastron
* Severely impaired renal function
* Hypocalcemia or primary hyperparathyroidism
* Central nervous system (CNS) metastases

Primary outcomes:
measure: Cumulative incidence of skeletal events according to Skeletal Morbidity Period Rate (SMPR)
timeFrame: Up to 25 weeks
Secondary outcomes:
measure: Incidence of bone pain according to participant questionnaire
timeFrame: Up to 25 weeks
measure: Analgesic consumption according to participant questionnaire
timeFrame: Up to 25 weeks
measure: Change in serum pyridinoline cross-linked carboxyterminal telopeptide of collagen type I (ICTP)
timeFrame: Up to 25 weeks
measure: Short Form 36 (SF-36) score
timeFrame: Up to 25 weeks
measure: Incidence of adverse events (AEs)
timeFrame: Up to approximately 7 months
Other outcomes:
Locations:
city: Plovdiv
country: Bulgaria
city: Shumen
country: Bulgaria
city: Sofia
country: Bulgaria
city: Sofia
country: Bulgaria
city: Sofia
country: Bulgaria
city: Stara Zagora
country: Bulgaria
city: Varna
country: Bulgaria
city: Veliko Tarnovo
country: Bulgaria
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_CHAIR
References:
Clinical trial NCT05876507: Effect of Progressive Exercise on Renal Transplant Patients
Official title: The Effects of Progressive Exercises on the Vital Signs and Fatigue in Patients With Renal Transplant
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Renal Transplant
Fatigue
Vital Signs
Progressive Relaxation Exercise
Nursing
Lead sponsor: Baskent University
Sponsor class: OTHER
First posted: 2023-05-25
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a single blind, randomized controlled study. The intervention group will receive an audio record explaining progressive relaxation exercise. Then participants will undergo training about the exercises. After training, the intervention group will perform the exercises at home by their own. The exercises will be performed everyday for 4 weeks about 25-30 minutes. Principal investigator will check the participants weekly about implementation of exercises.
Primary purpose: SUPPORTIVE_CARE

Brief summary: The goal of this interventional study is to determine the effect of progressive relaxation exercises on the vital signs and fatigue levels of patients with renal transplantation.

Detailed description: Renal transplant patients experience intense level of fatigue as well as vital sign problems due to treatment protocol. This research is designed to determine the effect of progressive relaxation exercises on vital signs and fatigue level of patients with renal transplantation.

In this study, the participants will be randomized in a single blind manner (participant) to either intervention (4 week exercise program) or control (routine care) groups.

Eligibility criteria: Inclusion Criteria:

* Patients underwent renal transplant within one year from the beginning of the study
* Patients having no communication problems
* Patients having a smart phone either own or o family member

Exclusion Criteria:

* Patients having musculoskeletal, cardiopulmonary, or psychiatric disorders

Primary outcomes:
measure: Systolic and diastolic blood pressure
timeFrame: Change fron baseline at 4th week
measure: fatigue level
timeFrame: Change from baseline at 4th week
measure: Heart rate
timeFrame: Change from baseline at 4th week
measure: Respiratory rate
timeFrame: Change from baseline at 4th week
measure: Body temperature
timeFrame: Change from baseline at 4th week
measure: Oxygen saturation
timeFrame: Change from baseline at 4th week
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Baskent University Hospital
state: Çankaya
Study officials:
References:
Clinical trial NCT04280107: Evaluation of Styloid Chain Calcification to the Patient With the Temporomandibular Joint Disorder
Official title: Evaluation of Styloid Chain Calcification to the Patient With the Temporomandibular Joint Disorder: a Retrospective Uncontrolled Cohort Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Styloid-Stylohoid Syndrome
Temporomandibular Disorder
Keywords: magnetic resonance imaging
cone beam computed tomography
temporomandibular dysfunction
Styloid-Stylohoid Syndrome
Lead sponsor: Nuh Naci Yazgan University
Sponsor class: OTHER
First posted: 2020-02-21
Enrollment: 47
Sex: ALL
Minimum age (years): 18
Maximum age (years): 81
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients have at least one of these clinic conditions: TMJ pain, mouth opening restriction, joint sound, joint function disorder.

Brief summary: The aim of the study was to evaluate any relation between elongated styloid process (ESP) and type of Temporomandibular Joint Disorders (TMD).

Detailed description: The styloid process (SP) of the temporal bone is a long conical cartilaginous projection lies anterior to the mastoid process. Patients who have ESP or styloid chain calcification are usually asymptomatic, only 4% are symptomatic. Symptoms vary as different syndromes which related affected anatomic structures by calcified process or ligament. Temporomandibular Dysfunction (TMD) describe the temporomandibular joint (TMJ) disfunction that divided three branches according to temporomandibular joint's disc status: non-displacement (ND), displacement with reduction (DWR) and displacement without reduction (DWoR). Since orofacial pain shows similar features in both ESP or styloid chain calcification and TMD, it is possible to confuse and misdiagnosis both of these clinical conditions. This study aimed to investigate the length and calcification pattern of the styloid process in patients with TMD diagnosis.

Eligibility criteria: Inclusion Criteria:

* Clinical Diagnosis of Temporomandibular Dysfunction(TMD)
* TMD patients with MR and CBCT images recorded in the digital archive.

Exclusion Criteria:

* operated or treated for any Temporomandibular Joint Diseases
* head and neck trauma
* orthodontic treatment

Primary outcomes:
measure: Styloid chain calsifiaction pattern
timeFrame: 2 months
measure: Styloid processes length
timeFrame: 2 months
Secondary outcomes:
Other outcomes:
Locations:
city: Kayseri
country: Turkey
facility: Nuh Naci Yazgan University
state: Kocasinan
Study officials:
References:
citation: Kis HC, Soydan Cabuk D. Evaluation of styloid chain calcification related to temporomandibular joint disc displacement: a retrospective cohort study. Oral Radiol. 2021 Jul;37(3):395-402. doi: 10.1007/s11282-020-00463-w. Epub 2020 Jul 6.
Clinical trial NCT04765007: Efficacy of Mindfulness Therapy in Orofacial Chronic Pain
Official title: Efficacy of Mindfulness Therapy in Orofacial Chronic Pain
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Mindfulness
Chronic Pain
Orofacial Pain
Keywords: mindfulness
chronic pain
orofacial pain
Lead sponsor: University of Jaén
Sponsor class: OTHER
First posted: 2021-02-21
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Psychological impairments have a significant role in management and coping of pain in patients with orofacial pain disorders. The response of this kind of pathologies to topical or systemic medications is not predictable and mindfulness breathing and relaxation techniques could present good results since it help patients to accept their problem and to cope it. In consequence, the present study is aimed to evaluate the efficacy of a mindfulness therapy program in management of chronic orofacial pain.


Eligibility criteria: Inclusion Criteria:

* Patients diagnosed of orofacial chronic pain by a physician.

Exclusion Criteria:

* Pain with oncologic origin
* Severe mental disorder

Primary outcomes:
measure: orofacial pain intensity
timeFrame: pre-intervention
measure: orofacial pain intensity
timeFrame: 8 weeks
measure: orofacial pain intensity
timeFrame: 5 months
measure: Symptoms of temporomandibular disorders
timeFrame: pre-intervention
measure: Symptoms of temporomandibular disorders
timeFrame: 8 weeks
measure: Symptoms of temporomandibular disorders
timeFrame: 5 months
measure: Catastrophization of pain
timeFrame: pre-intervention
measure: Catastrophization of pain
timeFrame: 8 weeks
measure: Catastrophization of pain
timeFrame: 5 months
measure: Kinesiophobia
timeFrame: pre-intervention
measure: Kinesiophobia
timeFrame: 8 weeks
measure: Kinesiophobia
timeFrame: 5 months
measure: Impact of headache
timeFrame: pre-intervention
measure: Impact of headache
timeFrame: 8 weeks
measure: Impact of headache
timeFrame: 5 months
measure: Sleep quality
timeFrame: pre-intervention
measure: Sleep quality
timeFrame: 8 weeks
measure: Sleep quality
timeFrame: 5 months
measure: Dizziness-related disability
timeFrame: pre-intervention
measure: Dizziness-related disability
timeFrame: 8 weeks
measure: Dizziness-related disability
timeFrame: 5 months
measure: Neck pain-related disability
timeFrame: pre-intervention
measure: Neck pain-related disability
timeFrame: 8 weeks
measure: Neck pain-related disability
timeFrame: 5 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00371007: MK-0431 Early Phase II Double-blind Study - Type 2 Diabetes Mellitus (0431-043)
Official title: MK0431 Early Phase II Double-blind Study - Type 2 Diabetes Mellitus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Type 2 Diabetes Mellitus
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2006-09-01
Enrollment: 126
Sex: ALL
Minimum age (years): 20
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A clinical study to determine the safety and efficacy of MK-0431 in patients with Type 2 diabetes mellitus who have inadequate glycemic control on diet/exercise therapy


Eligibility criteria: Inclusion Criteria:

* Patients have type 2 diabetes mellitus
* On diet/exercise therapy

Exclusion Criteria:

* Patients have type 1 diabetes mellitus

Primary outcomes:
measure: HbA1c, safety and tolerability
Secondary outcomes:
measure: Plasma glucose
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
citation: Nonaka K, Kakikawa T, Sato A, Okuyama K, Fujimoto G, Kato N, Suzuki H, Hirayama Y, Ahmed T, Davies MJ, Stein PP. Efficacy and safety of sitagliptin monotherapy in Japanese patients with type 2 diabetes. Diabetes Res Clin Pract. 2008 Feb;79(2):291-8. doi: 10.1016/j.diabres.2007.08.021. Epub 2007 Oct 22.
Clinical trial NCT04910607: Social and Psychological Impacts of SARS-Cov-2 Pandemic Period in the Obese Population.
Official title: Social and Psychological Impacts of SARS-Cov-2 Pandemic Period in the Obese Population.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Obesity
Covid19
Keywords: Obesity
COVID19
semi-directive interview
Lead sponsor: University Hospital, Bordeaux
Sponsor class: OTHER
Collaborators: name: Région Nouvelle Aquitaine
First posted: 2021-06-02
Enrollment: 279
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The obese population is the target population of the study.

Brief summary: The population suffering from obesity is particularly at risk during this pandemic period. The Nouvelle Aquitaine region is not spared, since according to the regional epidemiological report of 7 May 2020, carried out by Santé Publique France, 39.2% of cases admitted to the intensive care unit in Nouvelle Aquitaine and presenting risk factors are overweight or obese.

Other risk factors, such as social-environmental factors, must be taken into consideration. Socio-demographic surveys in this area highlight the socio-economic and territorial inequalities that interfere with obesity issues. Similarly, the issues of stigmatisation and isolation seem to be at the heart of the question of how to deal with these people.

Detailed description: This is a prospective multicentre study. Participating patients will be recruited from the Specialised Obesity Centres (CHU and SSR, as well as patient associations) to fill in a questionnaire and take part in an interview (a varied panel representative of the target population in terms of place of residence, socio-professional category, sex and age).

The medical and paramedical staff involved in the partner CSOs and the patients' resources (identified by the patients' associations) will also be asked to participate in a semi-directive interview.

Eligibility criteria: Inclusion Criteria:

* Patients 18 years of age.
* Be registered in an active file of the 3 partner CSOs.

Exclusion Criteria:

* Patients under 18 years of age.
* Patients under protective measures or deprived of liberty:

  * pregnant or breastfeeding woman,
  * under guardianship,
  * under guardianship,
  * safeguard of justice,
  * incarcerated.

Primary outcomes:
measure: Analysed social and psychological impacts of containment
timeFrame: 9 months after inclusion day
measure: Consequences of social distancing during the containment
timeFrame: 9 months after inclusion day
Secondary outcomes:
Other outcomes:
Locations:
city: Limoges
country: France
facility: CHU de Limoges
city: Pessac
country: France
facility: Hôpital Haut-Lévêque
city: Poitiers
country: France
facility: CHU de Poitiers
Study officials:
affiliation: Universite de Bordeaux
name: Arnaud ALESSANDRIN, Dr
role: STUDY_CHAIR
References:
Clinical trial NCT02032407: A Study of Dapsone Gel in Females With Skin of Color and Acne Vulgaris
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Acne Vulgaris
Lead sponsor: Allergan
Sponsor class: INDUSTRY
First posted: 2014-01-10
Enrollment: 68
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study will evaluate the effect of dapsone gel in female subjects with skin of color (Fitzpatrick Skin Types IV, V, and VI) with acne vulgaris.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of acne vulgaris
* Medium to dark complexion (Fitzpatrick Skin Type IV, V or VI)
* Willing to avoid excessive or prolonged exposure of the face to ultraviolet light (eg, sunlight, tanning beds) throughout the study

Exclusion Criteria:

* Received treatment with botulinum toxin of any serotype in the face within 6 months

Primary outcomes:
measure: Change From Baseline in the Global Assessment of Acne Severity (GAAS) Score by Physician
timeFrame: Baseline, Week 12
Secondary outcomes:
measure: Change From Baseline in the GAAS
timeFrame: Baseline, Weeks 2 and 6
measure: Percent Change From Baseline in Total Lesion Counts
timeFrame: Baseline, Weeks 2, 6 and 12
measure: Percent Change From Baseline in Inflammatory Lesion Counts
timeFrame: Baseline, Weeks 2, 6 and 12
measure: Percent Change From Baseline in Non-Inflammatory Lesion Counts
timeFrame: Baseline, Weeks 2, 6 and 12
measure: Percentage of Participants With 0 (None) or 1 (Minimal) on the GAAS
timeFrame: Weeks 2, 6 and 12
measure: Acne Symptom and Impact Scale (ASIS) Sign Domain Score
timeFrame: Weeks 2, 6 and 12
measure: ASIS Impact Domain Score
timeFrame: Weeks 2, 6 and 12
Other outcomes:
Locations:
city: Washington
country: United States
state: District of Columbia
Study officials:
affiliation: Allergan
name: Medical Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT06198088: Effects of PNF Technique in Children With Post Fracture Elbow Stiffness
Official title: Effects of Proprioception Neuromuscular Facilitation Technique in Children With Post Fracture Elbow Stiffness
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fracture
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2024-01-10
Enrollment: 26
Sex: ALL
Minimum age (years): 3
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Daily living activities are an essential part of a child's development, providing endless opportunities for play, learning, and imaginative expression. The desired result as the child get bored after a while so we use it for benefits. Proprioceptive Neuromuscular Facilitation is a stretching technique utilized to improve muscle elasticity and has been shown to have a positive effect on active and passive range of motions. In clinical settings, PNF is already utilized by therapists to restore functional range of motion (ROM) and increase strength in patients who have sustained soft tissue damage or received invasive surgeries.

Detailed description: This Randomized clinical trial study will be conducted in THQ hospital Arifwala/DHQ pakpattan with calculated sample size 26. Study will be approved by ethical committee. After that informed consent will be taken and patients will be randomly assigned to (Group A) control group these individuals will receive Maitland's mobilization with everyday object activities (Group B) experimental group (these individuals will receive baseline treatment and PNF technique ) frequency will be 5 session per week of 30 min and duration is of 4 weeks. Ranges will be assessed by Goniometry DASH outcome measure scale will use to assess functional activity. Data will be analyzed by SPSS latest version.

Eligibility criteria: Inclusion Criteria:

* Children Age 3-7 years
* Either gender
* Contracture 4-8 weeks post traumatic injuries.
* Post-operative

Exclusion Criteria:

* Burn contracture
* Contracture due to neurological conditions
* Dupytren's contracture, Volkmann's contracture etc.
* Contracture more than 8 week

Primary outcomes:
measure: DASH
timeFrame: 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: Riphah international university
Study officials:
affiliation: Riphah International University
name: Sumaira Bibi, MS*
role: PRINCIPAL_INVESTIGATOR
References:
citation: Sim G, Fleming J, Glasgow C. Mobilizing orthoses in the management of post-traumatic elbow contractures: A survey of Australian hand therapy practice. J Hand Ther. 2021 Jan-Mar;34(1):90-99. doi: 10.1016/j.jht.2019.12.014. Epub 2020 Mar 7.