louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01682057: A Multicenter Study to Evaluate the ROX Anastomotic Coupler System (ACS) In Patients With Severe Hypertension
Official title: A Prospective, Non-Randomized, Open Label, Multi-Center Study to Evaluate the ROX Anastomotic Coupler System (ACS) in Patients With Severe Hypertension
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Hypertension
Keywords: High Blood Pressure
Hypertension
Resistant Hypertension
Lead sponsor: ROX Medical, Inc.
Sponsor class: INDUSTRY
First posted: 2012-09-10
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the safety and performance of the ROX Anastomotic Coupler System (ACS) in patients with severe hypertension.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of severe hypertension must be made on the basis of current findings, medical history, and physical examination

Exclusion Criteria:

* Any serious medical condition that may adversely affect the patient's safety, limit the subject's ability to participate in the study, comply with follow-up requirements or impact the scientific integrity of the study.

Primary outcomes:
measure: Change in mean office SBP
timeFrame: Baseline, 6 months
Secondary outcomes:
measure: Change in mean office DBP
timeFrame: Change in mean office DBP six months as compared to Baseline
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: Universitair Ziekenhuis Brussel
Study officials:
References:
Clinical trial NCT06107257: Cardiogenic Acute Pulmonary Edema in Subjects Over 75 Years Old: Impact of Non-invasive Ventilation on Mortality
Official title: Cardiogenic Acute Pulmonary Edema in Subjects Over 75 Years Old: Impact of Non-invasive Ventilation on Mortality
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cardiogenic Pulmonary Edema
Keywords: Cardiogenic Pulmonary Edema
Acute pulmonary edema
Non-invasive ventilation
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2023-10-30
Enrollment: 200
Sex: ALL
Minimum age (years): 76
Standard ages: OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult subject (\> 75 years) with a diagnosis of cardiogenic PAO treated at Strasbourg University Hospital between January 1, 2021 and October 31, 2021

Brief summary: People aged over 75 represent almost 10% of the general population, and 12 to 14% of patients consulting emergency departments. Cardiogenic acute pulmonary edema (APO) is a very common reason for admission to the emergency room. The effectiveness of non-invasive ventilation (NIV) has been demonstrated during the management of PAO and would allow, compared to medical treatment alone, a more rapid improvement in clinical and gasometric parameters as well as a reduction in the need for ventilation. orotracheal intubation. On the other hand, the impact of NIV on mortality in cardiogenic PAO seems poorly defined, with lower levels of scientific evidence regarding a possible benefit in terms of survival, particularly in the elderly population.

The objective of this study is to determine whether the use of NIV in cardiogenic PAO in elderly subjects admitted to the emergency room of Strasbourg University Hospital would have an impact in terms of mortality up to 6 months compared to medical treatment alone.


Eligibility criteria: Inclusion Criteria:

* Adult subject (\> 75 years old)
* Admission to the NHC emergency room between January 1, 2021 and October 31, 2021
* Diagnosis of cardiogenic PAO
* Indication of NIV according to current recommendations
* Subject not opposing the reuse of their data for scientific research purposes.

Exclusion Criteria:

* Subject having expressed his opposition to the reuse of his data for scientific research purposes.
* Presence of an absolute contraindication to NIV
* Respiratory distress due to pneumonia or other diagnosis
* RT-PCR Sars Cov 2 positive in emergency

Primary outcomes:
measure: Survival Analysis
timeFrame: 6 months after cardiogenic acute pulmonary edema
Secondary outcomes:
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Gériatrie - Service de Soins de Soins Médicaux et de Réadaptation - CHU de Strasbourg - France
Study officials:
References:
Clinical trial NCT01679457: Assessing Models of Exposure Therapy
Official title: Assessing Models of Exposure Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obsessive-compulsive Disorders and Symptoms
Lead sponsor: Mclean Hospital
Sponsor class: OTHER
Collaborators: name: Utah State University
First posted: 2012-09-06
Enrollment: 29
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The objective of this study is to learn how to improve treatment for clients who are working hard in treatment at the McLean Hospital Obsessive Compulsive Disorder Institute (OCDI), but who are not making the progress that would typically be expected. Therefore, the investigators will be comparing the performance of such clients in a treatment as usual (TAU)-Exposure and Response Prevention (ERP) session with their performance in an Acceptance and Commitment Therapy (ACT)-focused ERP session that follows an ACT booster session. The investigators hypothesize that clients will perform significantly better in the ACT-focused ERP session than they will in the TAU-ERP session. More specifically, the investigators hypothesize that clients and an independent rater will report that in the ACT-focused ERP session, clients performed significantly fewer rituals and/or avoidance behaviors, experienced comparable levels of distress, exerted significantly more effort, had significantly less difficulty getting started with the ERP, were significantly less influenced by their uncomfortable thoughts/feelings, were significantly more willing to experience discomfort, were significantly more focused on working towards what is important to the client. The investigators also hypothesize that an independent rater will rate clients as significantly more compliant with the ACT-focused ERP session than with the TAU-ERP session. The investigators also hypothesize that clients will rate the ACT-focused ERP session as significantly more preferable and acceptable than the TAU-ERP session, and that they will report being significantly more willing to do the ACT-focused ERP session again.


Eligibility criteria: Inclusion Criteria:

* Participants will be adults at least 18 years of age currently enrolled in the residential or day treatment program at the OCDI.

Primary outcomes:
measure: Client Post-ERP Session Questions (Day 1).
timeFrame: Client Post-ERP Session Questions (Day 1) will be administered immediately after the "Day 1" TAU-ERP session.
measure: Client Post-ERP Session Questions (Day 2).
timeFrame: Client Post-ERP Session Questions (Day 2) will be administered immediately after the "Day 2" ACT-focused ERP session.
Secondary outcomes:
Other outcomes:
Locations:
city: Belmont
country: United States
facility: Obsessive Compulsive Disorder Institute at McLean Hospital
state: Massachusetts
Study officials:
affiliation: Mclean Hospital
name: Nate G Gruner, LICSW
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT07023757: Effect of Age on PRF Quality; Assessed by Evaluating Healing Outcomes of ARP
Official title: Effect of Age on PRF Quality; Assessed by Evaluating Healing Outcomes of ARP
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Healing Wound
Lead sponsor: University of Michigan
Sponsor class: OTHER
First posted: 2025-06-17
Enrollment: 44
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will examine whether using PRF and your age are going to affect the healing and regeneration benefits gained from PRF.

Detailed description: Platelet-rich fibrin (PRF) is commonly used to enhance gum tissue healing and reducing pain after tooth extraction and before placing a dental implant. 44 patients requiring a tooth extraction will be recruited and randomized to receive a collagen plug with or without platelet-rich fibrin.

Eligibility criteria: Inclusion Criteria:

1. Age range: 20 to 80 years.
2. Patients must require tooth extraction (molars) as a result of caries, periodontal disease, tooth fracture or deemed unrestorable.
3. Non-infected sockets with intact buccal bone (≥1.5 mm in thickness measured through calipers)
4. Patients interested in implant placement following tooth extraction.

Exclusion Criteria:

1. Allergies or hypersensitivities to study related medications.
2. Hematologic disorders/blood dyscrasias.
3. Active infectious diseases of any kind.
4. Liver or kidney dysfunction/failure.
5. Uncontrolled diabetes (HbA1c \> 8).
6. Active cancer treatment - such as active chemotherapy or radiation therapy.
7. Taking medications that will affect their bone healing (for example, bisphosphonates, Long-term NSAIDs use, Steroid).
8. Metabolic bone diseases that affect bone healing such as osteoporosis.
9. Pregnant or lactating women (self-reported).
10. Smoke 10 or more cigarettes per day (self-reported).
11. Poor oral hygiene.
12. Systemic diseases that compromise the immune system
13. Anti-coagulant therapy

Primary outcomes:
measure: Alveolar ridge dimension changes
timeFrame: 4 months
measure: Soft tissue dimension changes
timeFrame: 4 months
Secondary outcomes:
measure: Histological bone density.
timeFrame: 4 months
measure: Presence of bone turnover proteins.
timeFrame: 4 months
measure: Amount of growth factors
timeFrame: At baseline surgery
measure: Wound healing index
timeFrame: 1 week, 2 weeks, 4 weeks, and 8 weeks
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan School of Dentistry
state: Michigan
Study officials:
affiliation: University of Michigan
name: Muhammad Saleh, BDS, MSD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02571257: Efficacy and Safety of Gemcabene in Hypercholesterolemic Patients on Stable Statin Therapy
Official title: An 8-Week, Double-Blind, Placebo-Controlled, Randomized, Multicenter Study in Hypercholesterolemic Patients to Determine the Efficacy and Safety of Combination Therapy With CI-1027 and a Statin
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Hypercholesterolemia
Keywords: LDL-C
Lipid Regulator
Lead sponsor: NeuroBo Pharmaceuticals Inc.
Sponsor class: INDUSTRY
First posted: 2015-10-08
Enrollment: 66
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: The purpose of this study is to evaluate the effect of gemcabene on LDL-C and other lipid parameters in hypercholesterolemic patients on a stable dose of a statin.


Eligibility criteria: Inclusion Criteria:

* Males and Females
* 18 to 65 years of age
* Baseline LDL-C ≥ 130 mg/dL (3.4 mmol/L)

Exclusion Criteria:

* If female, postmenopausal or surgically menopausal
* Triglycerides (TG) \>400 mg/dL
* Creatine phosphokinase (CPK) \>3 × the upper limit of normal (ULN)
* Body Mass Index (BMI) \>35 kg/m2
* Uncontrolled diabetes mellitus (HbA1c \>10%)
* Renal dysfunction (blood urea nitrogen \[BUN\] or creatinine \>2 × ULN)
* Hepatic dysfunction (aspartate aminotransferase \[AST\] or alanine aminotransferase \[ALT\] \>2 × ULN)
* Myocardial infarction, severe or unstable angina pectoris, coronary angioplasty, coronary artery bypass graft, or any other major cardiovascular event resulting in hospitalization in previous month

Primary outcomes:
measure: LDL-C - percent change from baseline at Week 8
timeFrame: 56 days
Secondary outcomes:
measure: Plasma lipid levels - percent change from baseline at Week 8
timeFrame: 56 days
measure: Adverse Events
timeFrame: 56 days
measure: Clinical Laboratory
timeFrame: 56 days
Other outcomes:
Locations:
Study officials:
References:
citation: Stein E, Bays H, Koren M, Bakker-Arkema R, Bisgaier C. Efficacy and safety of gemcabene as add-on to stable statin therapy in hypercholesterolemic patients. J Clin Lipidol. 2016 Sep-Oct;10(5):1212-22. doi: 10.1016/j.jacl.2016.08.002. Epub 2016 Aug 10.
Clinical trial NCT03030157: Single Versus Long-term Intravesical Instillation Chemotherapy for Recurrence After Nephroureterectomy for Upper Tract Urothelial Carcinoma
Official title: Prospective Randomized Phase II Trial: Single Instillation Versus Long-term Prophylactic Intravesical Instillation of Pirarubicin in the Prevention of Bladder Recurrence After Nephroureterectomy for Primary Upper Tract Urothelial Carcinoma
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Intravesical Instillation
Keywords: urothelial cancer
bladder cancer
nephroureterectomy
Lead sponsor: RenJi Hospital
Sponsor class: OTHER
Collaborators: name: Shanghai Pudong Hospital
name: Shanghai Pudong New Area Gongli Hospital
First posted: 2017-01-24
Enrollment: 220
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Up to 30-40% of the patients may develop bladder recurrance after radical nephroureterectomy for primary upper tract urothelial carcinoma. Bladder tumor needs transurethral resection, which is associated with costs of treatment and potential poor prognosis. Although several randomized controlled trial have shown that prophylactic intravesical chemotherapy could prevent bladder tumor recurrence, the optimal schedule and duration of treatment are unkown. The investigators want to determine the efficiacy of single instillation versus long-term intravesical instillation of pirarubicin for bladder recurrence after radical nephrouretectomy for primary upper tract urothelial carcinoma.


Eligibility criteria: Inclusion Criteria:

* clinically diagnosed with upper tract urothelial carcinoma
* have no distant metastasis
* have an ECOG 0 to 2
* expected to receive radical nephroureterectomy

Exclusion Criteria:

* a prior history of bladder or synchronous bladder cancer
* administration of neoadjuvant chemotherapy
* the presence of severe complications
* deny to receive cytoscopy
* patients with advanced stage (T4)
* patients with contralateral UTUCs

Primary outcomes:
measure: The incidence of bladder cancer in the first 12 month following nephroureterectomy
timeFrame: 12 month
Secondary outcomes:
measure: Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
timeFrame: 2 day, 1 month and 12 month
measure: questionnaire for quality of life
timeFrame: baseline, 1 month and 12 month
measure: progression-free survival
timeFrame: 12 month
measure: cancer-specific survival
timeFrame: 12 month
measure: overall survival
timeFrame: 12 month
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Renji Hospital
state: Shanghai
Study officials:
References:
Clinical trial NCT04172857: Treatment of Malignant Glaucoma by Anterior Vitrectomy From Two Different Approaches
Official title: Treatment of Malignant Glaucoma Secondary to Cataract Surgery Combined With Goniosynechialysis by Anterior Vitrectomy From Two Different Approaches
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Glaucoma Secondary
Lead sponsor: Wenzhou Medical University
Sponsor class: OTHER
First posted: 2019-11-21
Enrollment: 9
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 medical records of all patients who developed clinical evidence of MG after Phaco-IOL-GSL, at the Affiliated Eye Hospital of Wenzhou Medical University from May 2015 to February 2018, were reviewed.

Brief summary: To compare the surgical outcomes of treating phacoemulsification with intraocular lens implantation combined with goniosynechialysis (Phaco-IOL-GSL) associated malignant glaucoma (MG), using different incision sites in anterior vitrectomy combined with hyaloidotomy, zonulectomy, and iridectomy (VHZI).


Eligibility criteria: Inclusion Criteria:

* MG was diagnosed based on the presence of a central and peripheral shallow anterior chamber with normal or elevated intraocular pressure (IOP).

Exclusion Criteria:

* The diagnosis was made only after confirming the absence of choroidal detachment or hemorrhage and posterior segment mass lesion, using B-scan ultrasonography or ophthalmoscopy

Primary outcomes:
measure: Relapse of MG
timeFrame: follow up: 3 to 31 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Qian Z, Chan YK, Wei L, Zheng B, Nie L, Pan W. Evaluation of Two Different Anterior Vitrectomies for Fluid Misdirection Syndrome Secondary to Cataract Surgery Combined with Goniosynechialysis. J Ophthalmol. 2020 Mar 23;2020:1934086. doi: 10.1155/2020/1934086. eCollection 2020.
Clinical trial NCT03799757: Using Bupivacaine Locally in the Mastectomy Drains to Control Postoperative Pain
Official title: Role of Wound Installation With Bupivacaine Through Surgical Drains in Postoperative Analgesia in Modified Radical Mastectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Pain, Postoperative
Breast Cancer
Keywords: bupivacaine
Post-mastectomy acute pain
Wound instillation
Lead sponsor: Alexandria University
Sponsor class: OTHER
First posted: 2019-01-10
Enrollment: 168
Sex: FEMALE
Minimum age (years): 30
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: in this study we are investigating the role of instillation of Bupivacaine through surgical drains at the end of mastectomy surgeries in controlling post operative pain and decreasing their pain killers requirement in the early postoperative period

Detailed description: patients were enrolled into 2 groups. in one group the wound was installed by 40ml of 0.25% bupivacaine through axillary and chest wall drains (20ml in each drain). Then, the drains were clamped for 20 minutes.

in the other group the wound was installed by 40ml of 0.9% normal saline through axillary and chest wall drains (20ml in each drain). Then, the drains were clamped for 20 minutes. (placebo group) patients and health care providers were blinded as regard the study group patients enrolled in. Visual Analog Pain Scale which is a score for detection of how much the patient is annoyed from the pain- was assessed two and four hours post-operative then every four hours thereafter.

Eligibility criteria: Inclusion Criteria:

female patients with unilateral breast cancer candidates for total mastectomy and axillary dissection

Exclusion Criteria:

1. Male patients
2. Bilateral breast cancer.
3. Patients with a history of a long duration of NSAID intake or other painkillers, drug abuse
4. Patients with chest wall pain like Tietze syndrome, history of angina pectoris or recent HZV infection.
5. Patients with known psychological or mental problems.
6. Patients who were not exposed to axillary dissection

Primary outcomes:
measure: Visual analogue pain score
timeFrame: first 24 hours
measure: Number of demands for analgesic
timeFrame: First 24 hours
measure: Timing of first demand for analgesic
timeFrame: First 24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Alexandria
country: Egypt
facility: Faculty of Medicine, Main Univeristy Hospital
Study officials:
affiliation: faculty of medicine , univeristy of alexandria
name: Mahmoud A Alhussini, md
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02655757: Effect of Sitagliptin on Progression of Coronary Intermediate Lesion
Official title: Effect of Sitagliptin on Progression of Coronary Intermediate Lesion in Patients With Coronary Heart Disease Complicated With Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Atherosclerosis
Type 2 Diabetes Mellitus
Lead sponsor: Chinese PLA General Hospital
Sponsor class: OTHER
First posted: 2016-01-14
Enrollment: 120
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: TREATMENT

Brief summary: This study was to investigate the Effect of Sitagliptin, a dipeptidyl peptidase-4 inhibitor, on Progression of Coronary Intermediate Lesion.


Eligibility criteria: Inclusion Criteria:

* Patients \> 18, \< 80 years old, with type 2 diabetes mellitus and angiographically proven Coronary Intermediate Lesion.

Exclusion Criteria:

* Allergy or hypersensitivity to any of the drug's components.
* Severe liver failure, moderate or severe kidney failure
* Malignant disease.
* Active infectious disease.
* Pregnancy or breastfeeding.

Primary outcomes:
measure: Changes in late lumen loss of target lesion
timeFrame: Changes from baseline in late lumen loss of target lesion at 12 months
Secondary outcomes:
measure: Incidence rate of MACE
timeFrame: Incidence rate of MACE from baseline to 12 months
Other outcomes:
Locations:
city: Beijing
country: China
facility: The General Hospital of PLA
state: Beijing
Study officials:
affiliation: The General Hospital of PLA
name: Chen yundai, MD
role: PRINCIPAL_INVESTIGATOR
References: