louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04124614: Brexpiprazole as Combination Therapy With Sertraline in Treatment of Adults With PTSD
Official title: A Phase 3, Multicenter, Randomized, Double-blind Trial of Brexpiprazole as Combination Therapy With Sertraline in the Treatment of Adults With Post-traumatic Stress Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Post Traumatic Stress Disorder
Keywords: PTSD
Lead sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.
Sponsor class: INDUSTRY
First posted: 2019-10-11
Enrollment: 450
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: This will be a 12-week, multicenter, randomized, double-blind trial evaluating the efficacy, safety, and tolerability of brexpiprazole + sertraline combination treatment in adult participants with Post-Traumatic Stress Disorder.


Eligibility criteria: Inclusion Criteria:

* Male and female outpatients 18 to 65 years of age, inclusive, at the time of informed consent.
* Participants who have PTSD, diagnosed according to the Diagnostic and Statistical Manual of Mental Disorders, 5th edition (DSM-5), and confirmed by the Mini International Neuropsychiatric Interview (MINI).
* Onset of symptoms meeting the DSM-5 criteria for PTSD symptoms for a minimum of 6 months prior to screening.

Exclusion Criteria:

* The index traumatic event that led to the develop of PTSD took place \> 9 years before screening.
* The index traumatic event occurred before age 16.
* Participants who have experienced a traumatic event within 3 months of screening.
* Participants who are receiving disability payments because of PTSD or any other psychiatric disorder; unless the disability payments will not be impacted by potential improvements demonstrated in the trial.

Primary outcomes:
measure: Change From Baseline in Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) Total Score
timeFrame: Baseline (Week 1), Week 10
Secondary outcomes:
measure: Change in Clinical Global Impression - Severity (CGI-S) Score
timeFrame: Baseline (Week 1), Week 10
measure: Change in Brief Inventory or Psychosocial Functions (B-IPF) Score
timeFrame: Baseline (Day 1), Week 12
Other outcomes:
Locations:
city: San Diego
country: United States
facility: For additional information regarding sites, contact 844-687-8522
state: California
Study officials:
References:
Clinical trial NCT01099514: Study of Nilotinib in Metastatic Melanoma With KIT Aberrations
Official title: Phase II Study of Nilotinib in Metastatic Melanoma With KIT Aberrations
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Metastatic Melanoma With KIT Aberration
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
First posted: 2010-04-07
Enrollment: 33
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Major response was observed to imatinib mesylate in KIT-mutated metastatic rectal melanoma (Hodi FS et al, J Clin Oncol 26:2046-2051, 2008). In the ASCO annual meeting in 2009ar, KIT mutations were reported to be present in 23% of acral and 15.2% of mucosal melanomas (Heinrich MC et al, J Clin Oncol 26:2008 abstr 9016). Nilotinib is a novel tyrosine kinase inhibitor (TKI) targeting KIT, PDGFR, and Bcr-Abl and inhibiting the proliferating of both imatinib-sensitive and imatinib-resistant cells in vitro. Phase I study of nilotinib alone and in combination with imatinib in patients with imatinib-resistant gastrointestinal stromal tumors (GIST) demonstrated significant activity (72% stable disease for nilotinib alone and 56% for nilotinib/imatinib combination) (Blay JY et al, J Clin Oncol 26:2008, abstr 10553).

Thus, we propose to conduct a phase II study of nilotinib in metastatic melanoma with KIT mutations.


Eligibility criteria: Inclusion Criteria:

1. Histologically or cytologically proven melanoma with stage IV or unresectable stage III disease
2. Documented KIT aberration
3. Adequate organ function as defined by the following criteria:

   * Serum aspartate transaminase (AST); serum glutamic oxaloacetic transaminase (SGOT)) and serum alanine transaminase (ALT); serum glutamic pyruvic transaminase (SGPT)) ≤ 2.5 x local laboratory upper limit of normal (ULN), or AST and ALT less than or equal to 5 x ULN if liver function abnormalities are due to underlying malignancy
   * Total serum bilirubin ≤ 1.5 x ULN
   * Absolute neutrophil count (ANC) ≥ 1500/µL
   * Platelets ≥ 100,000/µL
   * Hemoglobin ≥ 9.0 g/dL (may be transfused or erythropoietin treated)
   * Serum calcium ≤ 12.0 mg/dL
   * Serum creatinine ≤ 1.5 x ULN
4. Patients with CNS metastasis must have stable neurologic function without evidence of CNS progression within 8 weeks
5. May have previous adjuvant therapy with interferon, vaccines or therapy with IL-2, chemotherapy
6. At least one measurable lesion by RECIST criteria
7. ECOG PS 0-2

Exclusion Criteria:

1. Major surgery or radiation therapy within 4 weeks of starting the study treatment.
2. History of or known carcinomatous meningitis, or evidence of symptomatic leptomeningeal disease on screening CT or MRI scan.
3. Ongoing cardiac dysrhythmias of NCI CTCAE grade ≥ 2.
4. QTc \> 470 msec on baseline EKG.
5. Pregnancy or breastfeeding.

Primary outcomes:
measure: response rate
timeFrame: 1~2 year
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Cancer Center
Study officials:
References:
Clinical trial NCT05030714: Evaluation of a Novel Head-Mounted Device for Glaucoma Testing: A Proof-of-Concept Study
Official title: Evaluation of a Novel Head-Mounted Device for Glaucoma Testing: A Proof-of-Concept Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Glaucoma
Lead sponsor: Nova Scotia Health Authority
Sponsor class: OTHER
First posted: 2021-09-01
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: This proof-of-concept study aims to determine the feasibility and effectiveness of using a custom head-mounted device for visual field testing. The novel head-mounted device, with custom software, will be compared to a conventional visual field test: The Humphrey Visual Field Analyzer. The investigators will include 30 healthy normal patients, 30 glaucoma suspects, 30 patients with moderate glaucoma, and 30 patients with advanced glaucoma (total: 120 patients). Each patient will perform the conventional test and the head-mounted device visual field test during the study visit, with the order (i.e., which device the patient starts with) being randomized. After the two tests, the patient will fill out a questionnaire to gather information regarding patient comfort and satisfaction. This will repeat each week for 5 weeks, for a total of 5 study visits. The results of the tests (sensitivity thresholds) will be compared. The investigators hypothesize that the results of the conventional and head-mounted device will be similar.


Eligibility criteria: Inclusion Criteria:

* Previous visual field test with Humphrey Field Analyzer indicating normal field, early glaucomatous field damage, moderate glaucomatous field damage, or advanced glaucomatous field damage.
* Ability to understand and consent to the study.

Exclusion Criteria:

* Diagnosis of secondary glaucoma
* Diagnosis of non-glaucomatous optic neuropathy or other significant ophthalmic diagnosis that could limit vision (ex. age-related macular degeneration)
* Significant media opacity
* Previous intraocular surgery other than cataract surgery
* Anxiety disorder
* Pregnancy
* Seizure disorder
* Cardiac pacemaker or other implantable devices
* Severe vertigo or balance disturbance
* Refractive error greater than +4 diopters and less than -6 diopters spherical equivalent
* Inability to demonstrate competence to make informed decision regarding study participation

Primary outcomes:
measure: Visual field differential light sensitivity
timeFrame: 5 weeks
Secondary outcomes:
measure: Reproducibility of sensitivity values
timeFrame: 5 weeks
Other outcomes:
Locations:
city: Halifax
country: Canada
facility: Victoria General Hopsital - Nova Scotia Health Authority
state: Nova Scotia
city: Halifax
country: Canada
facility: Eadie Technologies Inc.
state: Nova Scotia
Study officials:
affiliation: Nova Scotia Healthy Authority
name: Brennan Eadie, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04686214: Body Temperature and Perioperative Bleeding in Adolescent Idiopathic Scoliosis Surgery
Official title: The Effect of the Alterations in Body Temperature to Perioperative Bleeding in Adolescent Idiopathic Scoliosis Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypothermia; Anesthesia
Lead sponsor: Istanbul University
Sponsor class: OTHER
First posted: 2020-12-28
Enrollment: 39
Sex: ALL
Minimum age (years): 12
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: In this study, patient groups in which normothermia is preserved by using multiple active warming methods in the intraoperative period in AIS surgery, followed by a single compressed air blowing system and allowed mild to moderate hypothermia were compared.


Eligibility criteria: Inclusion Criteria:

* Patients between the ages of 12-18 who were evaluated as ASI by axial skeletal deformity, who would undergo elective deformity correction surgery, who did not have scoliosis due to a secondary cause, and whose data were allowed to be used by themselves and parents

Exclusion Criteria:

* Patients with body weight \<35kg, morbid obesity (BMI\> 40kg / m2), known allergy, known bleeding-coagulation disease, use of drugs that affect blood clotting parameters in the last week, presence of hepatic, renal, hematological, rheumatological disease, the patient's own or family with psychiatric disorders who could not cooperate

Primary outcomes:
measure: blood loss in the group of patients who are kept normothermic
timeFrame: surgery time (approximately 2 hours)
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul University, Faculty of Medicine
state: Fatih
Study officials:
References:
citation: Gozubuyuk E, Aygun E, Basaran I, Canbolat N, Cavdaroglu B, Akgul T, Buget MI. Effects of Changes in Body Temperature on Perioperative Bleeding in Adolescent Idiopathic Scoliosis Surgery. Ther Hypothermia Temp Manag. 2022 Sep;12(3):146-154. doi: 10.1089/ther.2021.0016. Epub 2021 Oct 18.
Clinical trial NCT05155514: Pulse Wave Velocity and Hemodynamic Response During Anesthesia Induction in Hypertensive Patients
Official title: Comparison of the Relationship Between Preoperatively Measured Pulse Wave Velocity and Hemodynamic Changes During Anesthesia Induction in Hypertensive and Normotensive Patients.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Arterial Stiffness
Lead sponsor: Aydin Adnan Menderes University
Sponsor class: OTHER
First posted: 2021-12-13
Enrollment: 139
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All Patients aged 50 and over

Brief summary: Hypertension is a disease with increasing and serious complications all over the world. In particular, the incidence of hypertension increases with advancing age. Secondary problems that can be caused by hypertension include peripheral vascular diseases, arteriosclerosis, increased risk of heart attack and stroke. It is a measurement of pulse wave velocity (PWV), a non-invasive indicator of arterial stiffness. It is known that sudden hemodynamic changes that occur during the induction of anesthesia cause undesirable intraoperative and postoperative complications. It is known that arterial stiffness, which is more common in elderly patients, causes orthostatic hypotension in particular. For this reason, more hemodynamic instability may be seen in the general anesthesia procedure in elderly patients with increased arterial stiffness.

In our study, we aimed to investigate whether the hemodynamic changes observed during anesthesia induction in hypertensive elderly patients, whom we think have a high pulse wave velocity, are different from normotensive patients.


Eligibility criteria: Inclusion Criteria:

* According to the American Society of Anesthesiologists (ASA), physical condition I-II,
* Elective otolaryngology surgery with endotracheal intubation planned
* Patients aged 50 and over

Exclusion Criteria:

* Hypersensitivity to drugs
* Difficult intubation history
* Diabetes mellitus receiving insulin therapy
* Chronic renal failure or end-stage renal disease
* Heart failure (left ventricular ejection fraction ≤30%)
* Valve disease (moderate to severe)
* Atrial fibrillation

Primary outcomes:
measure: Difference between hemodynamic values
timeFrame: Basal measurement before induction of anesthesia, then at 1-minute intervals until after endotracheal intubation
Secondary outcomes:
Other outcomes:
Locations:
city: Aydın
country: Turkey
facility: Aydın Adnan Menderes University Faculty of Medicine, Department of Anesthesiology and Reanimation
Study officials:
References:
Clinical trial NCT01509014: Community Pharmacy Assisting in Total Cardiovascular Health
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Statin Therapy
Adherence
Keywords: Statins
Adherence
Pharmacists
Lead sponsor: University of Saskatchewan
Sponsor class: OTHER
Collaborators: name: Ministry of Health, Saskatchewan
name: Merck Frosst Canada Ltd.
First posted: 2012-01-12
Enrollment: 2250
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Despite proven benefits in reducing morbidity and mortality, many patients become nonadherent to statin therapy within the first year of starting. Due to their accessibility and frequent patient contact, pharmacists are well-positioned to improve medication adherence.

The purpose of this study is to determine whether a simple intervention by community pharmacists can improve statin adherence in new statin users.


Eligibility criteria: Inclusion Criteria:

* Pharmacies must fill at least 85 statin prescriptions in a six-week period
* CPATCH intervention was given priority over other study initiatives offered by the pharmacy
* All members of pharmacy staff provided informed consent

Primary outcomes:
measure: Mean statin adherence among all eligible new users of statin medications with at least 6 months of follow-up from index prescription
timeFrame: 6 months
Secondary outcomes:
measure: Proportion of new statin users with adherence greater than or equal to 80%
timeFrame: 6 months
measure: Persistence with statin use among patients with a minimum of 12 months of follow-up
timeFrame: 6 months
Other outcomes:
Locations:
city: Saskatoon
country: Canada
facility: College of Pharmacy and Nutrition, University of Saskatchewan
state: Saskatchewan
Study officials:
References:
citation: Evans CD, Eurich DT, Taylor JG, Remillard AJ, Shevchuk YM, Blackburn DF. A pragmatic cluster randomized trial evaluating the impact of a community pharmacy intervention on statin adherence: rationale and design of the Community Pharmacy Assisting in Total Cardiovascular Health (CPATCH) study. Trials. 2010 Jul 8;11:76. doi: 10.1186/1745-6215-11-76.
Clinical trial NCT05474014: Superior Trunk Block Applied for Upper Arm Surgery
Official title: Investigation of the Effectiveness of Superior Trunk Block Applied for Upper Arm Surgery Operation Analgesia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Post Operative Pain
Lead sponsor: Bursa Yüksek İhtisas Education and Research Hospital
Sponsor class: OTHER_GOV
First posted: 2022-07-26
Enrollment: 60
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: Nerve blocks applied with ultrasonography are currently used for many post-operative pain and operations. Providing adequate area analgesia is the primary goal of clinicians, as early mobilization is suggested after shoulder and arm surgery.

In this study aimed to investigate the effect of superior trunk block application on postoperative analgesic and motor functions.


Eligibility criteria: Inclusion Criteria:

* Patients who were in the American Society of Anesthesiologists (ASA) I-III class
* Underwent upper arm surgery

Exclusion Criteria:

* Previous local anesthetic allergy,
* Having a bleeding diathesis disorder,
* Mental disorder,
* Allergic to the drugs used,
* Patients who did not consent to participate in the study,
* Presence of infection in the block area,
* Patients with a body mass index above 30

Primary outcomes:
measure: Visual Analog Scale
timeFrame: Postoperative 24 hours
Secondary outcomes:
measure: tramadol consumption amount
timeFrame: Postoperative 24 hours
measure: additional analgesic use amount
timeFrame: Postoperative 24 hours
measure: postoperative complications
timeFrame: Postoperative 24 hours
measure: Horner syndrome
timeFrame: Postoperative 24 hours
Other outcomes:
Locations:
city: Bursa
country: Turkey
facility: Bursa Yuksek Ihtisas Training and Research Hospital
Study officials:
affiliation: Sağlık Bilimleri Üniversitesi Bursa Yüksek İhtisas Eğitim Ve Araştırma Hastanesi
name: Korgün Ökmen, Assoc. PhD.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06242314: L-PRF Versus A-PRF on Palatal Wound Healing
Official title: Comparison of The Effect of A-PRF and L-PRF Application to The Palatal Region on Quality of Life and Wound Healing After Free Gingival Graft Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Palate; Wound
Keywords: free gingival graft
platelet rich fibrin
Lead sponsor: Izmir Katip Celebi University
Sponsor class: OTHER
First posted: 2024-02-05
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Different approaches are used to reduce post-operative complications associated with the palatal wound site after free gingival graft (FGG) harvesting. The aim of this study was to compare the effects of L-PRF and A-PRF on palatal wound healing after free gingival graft harvesting and patients' quality of life.

Detailed description: Thirty-six patients between the ages of 18 and 60 years (11 males and 25 females) who had completed Phase 1 periodontal treatments and for whom FGG surgery was indicated for isolated gingival recession defects limited to one or two teeth with shallow vestibule and insufficient keratinized or attached gingival width were included in the present study.

Three different treatments were performed on palatal wound areas: L-PRF (L-PRF group, n = 12), A-PRF (A-PRF group, n = 12) and palatal stent (control group, n = 12) OHIP-14 scores, VAS scores (for pain), analgesic tablet intake, and epithelialization condition were recorded for different time points.

Eligibility criteria: Inclusion Criteria:

• Patients ≥18 years requiring FGG surgery because of shallow vestibule and insufficient keratinized/attached gingival width

Exclusion Criteria:

* no smoking /no alcohol use,
* not suffering from any systemic disease that could impair the healing of wounds,
* pregnancy or lactation,
* Previous graft harvesting from the same site.

Primary outcomes:
measure: Epithelialization
timeFrame: 1 month
Secondary outcomes:
measure: Pain at Palatal wound area
timeFrame: First 7 days and day 14
measure: Pain at Palatal wound area
timeFrame: First 7 days
measure: Oral health-related quality of life (OHRQoL)
timeFrame: 7 and 14 days after free gingival graft surgery
Other outcomes:
Locations:
city: İzmir
country: Turkey
facility: Mehmet Sağlam
state: Çiğli
Study officials:
References:
Clinical trial NCT04197414: Development of Urologic Registry for Personalized Medicine in Patients With Urological Malignancy by Analyzing Circulating Tumor DNA
Official title: Development of Urologic Registry for Personalized Medicine in Patients With Urological Malignancy by Analyzing Circulating Tumor DNA
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Prostate Cancer
Renal Cell Cancer
Bladder Cancer
Ureter Cancer
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2019-12-13
Enrollment: 3000
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who have undergone surgeries with urological malignancies (prostate cancer, renal cell cancer, bladder cancer, and ureter cancer) in Severance Hospital, Sinchon from 2019.12 and 2029.11 were selected.

Brief summary: Urological malignancies such as prostate cancer and renal cell cancer in Korean population have been increased due to the aged population and the westernized lifestyles. With the advancement of sequencing technologies, use of genetic mutation profiles in cancer detection and progression has been increased. However, use of circulating tumor DNA in urological malignances have been limited and few studies have been reported. Therefore, we tried to evaluate the usefulness of circulating tumor DNA in detection and monitoring of urological malignancies in Korean population. This study aims to use circulating tumor DNA in plasma and urine for the diagnosis, disease progression monitoring and therapeutic response evaluation. This study plan includes building big databases for circulating tumor DNA of urological malignancies in Korean population and to develop optimized circulating tumor DNA platform.


Eligibility criteria: Inclusion Criteria:

* 1. Patients diagnosed as urological malignances (prostate cancer, renal cell cancer, bladder cancer, and ureter cancer)
* 2. Patients who have undergone surgeries due to urological malignancies in Severance Hospital, Sinchon from 2019.12 and 2029.11
* 3. Those who agree to give permission to use their human source information - 4. Those who agree with this study

Exclusion Criteria:

* 1. Those who do not agree with this study
* 2. Vulnerable participants who are likely to be vulnerable to coercion or undue influence or lack decision-making

Primary outcomes:
measure: Correlation between genetic mutations of circulating tumor DNA in plasma and urine samples and genetic mutations of primary tumor tissue samples
timeFrame: within 2 weeks after the surgery
Secondary outcomes:
measure: Correlation between circulating tumor DNA and early diagnosis and prognosis in urological malignancies
timeFrame: within 10 years after the surgery
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Department of Urology, Urological Science Institute, Yonsei University, Colleage of Medicine
Study officials:
References: