louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05390515: Psoriatic Immune Response to Tildrakizumab
Official title: Psoriatic Immune Response to Tildrakizumab
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Psoriasis Vulgaris
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: Sun Pharmaceutical Industries Limited
First posted: 2022-05-25
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: This study aims to assess cutaneous and blood immune cell function of patients with psoriasis before and after initiation of treatment with the IL23 blocker, tildrakizumab.

Detailed description: This is a one-arm, open-label study to examine the effect of Tildrakizumab on cutaneous and blood immune cells of psoriatic patients. Ten subjects with moderate to severe psoriasis will be enrolled. Biopsy and blood samples will be collected before and during treatment and undergo molecular profiling to assess for tildrakizumab-corrected signatures.

Eligibility criteria: Inclusion Criteria:

* 18 years of age or older
* Patients with moderate-severe psoriasis or \> 5% body surface area affected.

Exclusion Criteria:

* taking systemic immunosuppressives in the last 4 weeks
* pregnancy
* severe immunodeficiency (either from genetic or infectious causes).
* tuberculosis or other active serious infection
* active systemic malignancy.
* breast-feeding
* Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient or the quality of the data.

Primary outcomes:
measure: Change in Psoriasis Area and Severity Index (PASI) Score at baseline and 3 months of treatment
timeFrame: Baseline, 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: University of California, San Francisco
state: California
Study officials:
affiliation: University of California, San Francisco
name: Raymond Cho, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01342315: Topical Antifungal Treatment for Tinea Cruris
Official title: A Randomized, Multi-Center, Double-Blind, Vehicle-Controlled Study Evaluating the Efficacy and Safety of Product 33525 in Subjects With Tinea Cruris
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Tinea Cruris
Keywords: Tinea Cruris, antifungal
Lead sponsor: Medicis Global Service Corporation
Sponsor class: INDUSTRY
First posted: 2011-04-27
Enrollment: 483
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To determine if a topical antifungal cream is safe and effective for the treatment of tinea cruris


Eligibility criteria: Inclusion Criteria:

* moderate erythema, mild scaling, and moderate pruritis

Exclusion Criteria:

* pregnancy and allergies

Primary outcomes:
measure: Proportion of patients achieving complete clearance
timeFrame: 3 weeks post-treatment
Secondary outcomes:
measure: Proportion of patients achieving effective treatment
timeFrame: 1 week Post Treatment, 2 weeks Post Treatment, and 3 weeks Post Treatment
Other outcomes:
Locations:
city: Fremont
country: United States
state: California
city: Los Angeles
country: United States
state: California
city: Miami
country: United States
state: Florida
city: Miramar
country: United States
state: Florida
city: St. Petersburg
country: United States
state: Florida
city: Evansville
country: United States
state: Indiana
city: Warren
country: United States
state: Michigan
city: Paramus
country: United States
state: New Jersey
city: Albuquerque
country: United States
state: New Mexico
city: Cincinatti
country: United States
state: Ohio
city: Philadelphia
country: United States
state: Pennsylvania
city: Goodletsville
country: United States
state: Tennessee
city: Austin
country: United States
state: Texas
city: College Station
country: United States
state: Texas
city: Plano
country: United States
state: Texas
city: San Antonio
country: United States
state: Texas
city: Lynchburg
country: United States
state: Virginia
city: Belize City
country: Belize
city: San Salvador
country: El Salvador
city: San Pedro Sula
country: Honduras
city: Cidra
country: Puerto Rico
Study officials:
affiliation: Medicis Pharmaceutical
name: Ron Staugaard
role: STUDY_DIRECTOR
References:
Clinical trial NCT04571515: Dose-Response Study of MR-107A-01 in The Treatment of Post-Surgical Dental Pain
Official title: A Randomized, Double Blind, Placebo-Controlled, Parallel Group, Dose-Response Study of MR-107A-01 in The Treatment of Post-Surgical Dental Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Pain
Postoperative Pain
Pain, Acute
Lead sponsor: Viatris Inc.
Sponsor class: INDUSTRY
First posted: 2020-10-01
Enrollment: 114
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: MR-107A-01 is being studied to investigate its efficacy, safety, and dose-response after dental surgery.


Eligibility criteria: Inclusion Criteria:

1. Males and females ≥18 years of age.
2. Requirement for dental surgery for extraction of ≥2 x third molars, at least 1 of which involves partial or complete mandibular bony impaction.
3. Pain Intensity (PI) using a Numeric Pain Rating Scale (NPRS) ≥5 during the 5 hours following the end of surgery.
4. Rating of moderate or severe pain on a 4-point categorical pain rating scale (i.e., none, mild, moderate, severe) during the 5 hours following the end of surgery.

Exclusion Criteria:

1. Previously dosed with MR-107A-01.
2. Subject with known hypersensitivity to nonsteroidal antiinflammatory drugs (NSAIDs).
3. Active GI bleeding or a history of peptic ulcer disease, active inflammatory bowel disease, e.g., Crohn's Disease or ulcerative colitis, bleeding disorders that may affect coagulation.
4. Use of any investigational drug within 28 days, or 5 half-lives, prior to screening whichever is longer.
5. Use of medications with the potential to interact with MR-107A-01.
6. Other acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study.

Primary outcomes:
measure: Overall Summed Pain Intensity Difference (SPID)
timeFrame: 24 hours after the first dose
Secondary outcomes:
measure: Pain Intensity Using a Numeric Pain Rating Scale Utilizing 2-hour Windowed Last Observation Carried Forward (W2LOCF)
timeFrame: 24 hours after the first dose
measure: Total Pain Relief
timeFrame: 24 hours after the first dose
measure: Pain Relief: Number and Percentage of Subjects With Perceptible and Meaningful Pain Relief
timeFrame: 24 hours after the first dose
measure: Patient's Global Assessment of Pain Control
timeFrame: 24 hours after the first dose
measure: Rescue Medication Use
timeFrame: 24 hours after the first dose
Other outcomes:
Locations:
city: Salt Lake City
country: United States
facility: Research Facility 101
state: Utah
Study officials:
affiliation: MEDA Pharma GmbH & Co. KG (A Viatris Company)
name: Susanne Vogt
role: STUDY_DIRECTOR
References:
Clinical trial NCT06819215: Phase I/II Clinical Study to Evaluate VB15010 Tablets in Patients With Advanced Solid Tumors
Official title: Phase I/II Clinical Study To Evaluate The Safety, Tolerability, Pharmacokinetics, Pharmacodynamics And Preliminary Efficacy of VB15010 Tablets In Patients With Advanced Solid Tumors
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
PHASE2
Conditions: Cancer
Neoplasms
Neoplasms, Breast
Tumor
PARP
Ovarian Neoplasms
Prostatic Cancer
Pancreatic Cancer
Breast Cancer
Biliary Cancer
Colorectal Cancer
Keywords: VB15010
PARP
Ovarian cancer
Prostatic Cancer
Pancreatic cancer
Breast cancer
Biliary Cancer
Lead sponsor: Shenzhen Yangli Pharmaceutical Technology Co., Ltd
Sponsor class: INDUSTRY
Collaborators: name: Shandong Cancer Hospital and Institute
First posted: 2025-02-11
Enrollment: 188
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This research is designed to determine if experimental treatment with PARP1 inhibitor, VB15010 is safe, tolerable, and has anti-cancer activity in patients with advanced solid tumors.


Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 at the time of screening;
* Histological or cytological confirmation of advanced malignancy ;
* Progressive cancer at the time of study entry;
* Adequate organ and marrow function as defined by the protocol;
* Homologous recombination repair gene mutation.

Exclusion Criteria:

* Major surgery within 4 weeks of the ﬁrst dose of study treatment.
* Spinal cord compression or brain metastases unless asymptomatic, treated and stable and not requiring continuous corticosteroids at a dose of \>10mg prednisone/day or equivalent for at least 4 weeks prior to start of study treatment. Patients with leptomeningeal carcinomatosis are excluded.
* Patients with myelodysplastic syndrome/acute myeloid leukaemia or with features suggestive of myelodysplastic syndrome (MDS)/acute myeloid leukaemia (AML).

Primary outcomes:
measure: The number of subjects with adverse events/serious adverse events
timeFrame: From time of Informed Consent to 30+7 days post last dose
measure: The number of subjects with dose-limiting toxicity (DLT), as deﬁned in the protocol.
timeFrame: At the end of Cycle 1(each cycle is 28 days)
Secondary outcomes:
measure: Maximum plasma concentration of the drug (Cmax)
timeFrame: At predefined intervals throughout the treatment period (through study completion, an everage of 1 year)
measure: Objective Response Rate (prostate cancer)
timeFrame: From Screening to conﬁrmed progressive disease (approximately 1 year)
Other outcomes:
Locations:
city: Jinan
country: China
facility: Cancer Hospital of Shandong First Medical university
state: Shandong
Study officials:
References:
Clinical trial NCT06664515: Changes InMPOD After Full-thickness Macular Hole Closure
Official title: Changes in Macular Pigment Optical Density After Full-thickness Macular Hole Closure Using Inverted Flap Technique
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Full Macular Hole
Lead sponsor: Federico II University
Sponsor class: OTHER
First posted: 2024-10-29
Enrollment: 15
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The participans were older than 50 years with diagnosis of FTHM and underwent invert flap surgery.The participans did not present other ophthalmological diseases.

Brief summary: The notable increase in MPOD following successful surgery suggests its potential role as a valuable adjunctive biomarker associated with a good visual prognosis following this type of macular hole surgical interventions.

Detailed description: Full-thickness macular hole (FTMH) is a debilitating retinal disorder, particularly in its advanced forms, necessitating surgical intervention for vision restoration. This study showes the successful closure of a large FTMH using the inverted flap technique, highlighting the essential role of multimodal imaging, and particularly of macular pigment optical density (MPOD) assessment, in preoperative and postoperative evaluation.

Surgery was performed by an expert vitreoretinal surgeon, resulting in significant postoperative improvements in visual acuity and retinal architecture. Multimodal imaging, including MPOD assessment, played a pivotal role in preoperative evaluation and postoperative monitoring.

Eligibility criteria: Inclusion Criteria:age older than 60 years

* diagnosis of FTHM
* absence of other ocular diseases, responsible for macular edema (retinal vein occlusion, diabetic retinopathy, age-related macular degeneration

Exclusion Criteria:

No diagnosis of pseudophakic cystoid macular oedema

* previous treatment for pseudophakic cystoid macular oedema
* presence of other ocular diseases, responsible for macular edema (retinal vein occlusion, diabetic retinopathy, age-related macular degeneration)

Primary outcomes:
measure: MPOD After Full-thickness Macular Hole Closure (FTMH)
timeFrame: 6 months
measure: MPOD and Macula hole: before and after surgery
timeFrame: six months
Secondary outcomes:
Other outcomes:
Locations:
city: Naples
country: Italy
facility: University of Naples "Federico II"
Study officials:
affiliation: FEDERICOII UNIVERSITY
name: Ciro Costagliola
role: STUDY_CHAIR
References:
Clinical trial NCT03448315: Role of Transcrainal Direct Current Brain Stimulation in Acute and Chronic Post-mastectomy Pain Management
Official title: Role of Transcrainal Direct Current Brain Stimulation in Acute and Chronic Post-mastectomy Pain Management
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Postoperative Pain
Keywords: brain stimulation, tDCS, acute postoperative pain, chronic pain
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2018-02-28
Enrollment: 30
Sex: FEMALE
Minimum age (years): 30
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: the role of transcranial magnetic stimulation over the primary motor cortex area on acute postoperative pain after breast cancer surgery and on the probability of developing chronic neuropathic pain.

Detailed description: New analgesic strategies are needed that can be used adjunctively to existing strategies with the potential to reduce reliance on opioid analgesia. Several novel brain stimulation technologies including transcranial direct current stimulation (tDCS) are beginning to demonstrate promise as treatments for a variety of pain conditions. Electricity has no metabolite or other residue, and can be delivered with minimal discomfort and without problems associated with drug-drug interactions.Transcranial direct current stimulation has been studied in patients with various disorders and multiple pain syndromes. There is also evidence that tDCS might be useful in postsurgical pain reduction.

Eligibility criteria: Inclusion Criteria:

* ASA I-II, scheduled for unilateral modified radical mastectomy with axillary dissection for breast cancer

Exclusion Criteria:

* patients with intracranial metallic devices or with pacemakers or any other device.
* patients with Neurological or psychiatric disorders,
* patients taking major centrally acting drugs (antiepileptics or antidepressants), -opioid dependence,
* substance abuse,
* severe cardiopulmonary, renal, hepatic diseases, and
* those with extensive myocardial ischemia or unstable angina.

Primary outcomes:
measure: total morphine comsuption
timeFrame: 48 hours
Secondary outcomes:
measure: Visual analogue scale
timeFrame: baseline,at 2,4,6, 12, 24,36,48 hours
measure: Douleur Neuropathique 4 questions DN4
timeFrame: 1month, 3month, 6 month
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: South Egypt Cancer Institute
Study officials:
References:
Clinical trial NCT04485715: Application of AI in Polypectomy
Official title: Application of Artificial Intelligence in Colorectal Polypectomy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Colonic Polyp
Lead sponsor: Shandong University
Sponsor class: OTHER
First posted: 2020-07-24
Enrollment: 1000
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: OTHER

Brief summary: The aim of this study was to assess the performance of AI system in polypectomy


Eligibility criteria: Inclusion Criteria:

* to undergo colorectal polypectomy;
* agree to give written informed consent

Exclusion Criteria:

* patients with the contraindications to colorectal polypectomy;
* patients with a history of inflammatory bowel disease (IBD), CRC, colorectal surgery;
* patients with high suspicion of polyposis syndromes, IBD and typical advanced CRC;
* patients refused to participate in the trial;
* the procedure cannot be completed due to stenosis, obstruction, huge occupying lesions, or solid stool;
* the procedure have to be terminated due to complications of anaesthesia.

Primary outcomes:
measure: polypectomy time
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Jinan
country: China
facility: Department of Gastroenterology, Qilu Hospital, Shandong University
state: Shandong
Study officials:
References:
Clinical trial NCT02784015: Response Based Treatment for Children With Unresectable Localized Soft Tissue Sarcoma
Official title: Response-based Treatment for Children With Unresectable Localized Soft Tissue Sarcomas
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Unresectable Localized Soft Tissue Sarcoma
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
First posted: 2016-05-26
Enrollment: 41
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To evaluate the treatment outcome of unresectable soft tissue sarcoma using response based treatment

Detailed description: Response after initial chemotherapy is one of the important prognostic factor in many cancers. In this study, treatment will be tailored according to the treatment responses which are assessed by tumor volume reduction, necrosis rate or residual fludeoxyglucose (FDG) uptake in positron emission tomography (PET) scan.

Eligibility criteria: Inclusion Criteria:

* Patients with unresectable localized high grade soft tissue sarcoma

Exclusion Criteria:

* Patients with organ dysfunction (ejection fraction, liver function test, creatinine \> CTCAE grade 2)

Primary outcomes:
measure: Rate of event free survival
timeFrame: Up to 3 years
Secondary outcomes:
measure: Rate of adverse events
timeFrame: Up to 3 years
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
Study officials:
References:
Clinical trial NCT01959815: Novel Screening Strategies for Scleroderma PAH
Official title: Novel Screening Strategies for Scleroderma PAH (Pulmonary Arterial Hypertension)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pulmonary Arterial Hypertension
Scleroderma
Lead sponsor: University of Michigan
Sponsor class: OTHER
First posted: 2013-10-10
Enrollment: 156
Sex: ALL
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Volunteers will be recruited from scleroderma clinics, pulmonary hypertension clinics, and (for healthy volunteers) the Ann Arbor area.

Brief summary: Patients with scleroderma can develop heart failure due to high blood pressure in the lungs (a condition called pulmonary arterial hypertension). It is important to find pulmonary arterial hypertension early, so that it can be treated before heart failure develops. However, the tests that we now use to find the earliest form of this disease in scleroderma patients are not good enough. This study will examine whether tests performed during exercise can improve our ability to find early pulmonary arterial hypertension. The study will also try to identify genes that are responsible for the development of pulmonary arterial hypertension.


Eligibility criteria: Inclusion Criteria:

* 30 years or older;
* diagnosis of limited or diffuse scleroderma (American College of Rheumatology criteria)
* for the "high risk" group, one of the following features:

  * resting transthoracic echocardiogram showing elevated right-sided pressures within previous 3 months \[tricuspid regurgitation (TR) jet \>2.8 m/s or evidence of right ventricular dysfunction\]
  * pulmonary function testing (PFT) showing abnormal diffusing capacity of carbon monoxide (DLCO) not due to significant interstitial lung disease (DLCO\<60% predicted or FVC: DLCO ratio \>1.4)

Exclusion Criteria:

* Pregnancy
* prior diagnosis of pulmonary hypertension
* treatment with endothelin receptor antagonists, phosphodiesterase-5 inhibitors, or prostacyclin analogues
* previous diagnosis of obstructive lung disease or pulmonary thromboembolic disease
* current smoker
* significant valvular disease
* resting echocardiogram showing left ventricular ejection fraction\<50% within previous 3 months
* resting echocardiogram showing significant (greater than Grade I) diastolic dysfunction
* pulmonary emboli (past or present).

Primary outcomes:
measure: Development of pulmonary arterial hypertension
timeFrame: Two years after enrollment.
Secondary outcomes:
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
Study officials:
affiliation: University of Michigan
name: Scott H Visovatti, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00697385: The Use of Cyclokapron for Treatment and Management of Women With Bleeding Disorders
Official title: Open Label Continuation Study for the Use of Cyclokapron for Treatment and Management of Women With Bleeding Disorders
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: vonWillebrand Disease
Hemophilia
Platelet Coagulation Disorders
Lead sponsor: Mary M. Gooley Hemophilia Center
Sponsor class: OTHER
First posted: 2008-06-13
Enrollment: 13
Sex: FEMALE
Minimum age (years): 8
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The high percentage of failure using available non-surgical options to treat menorrhagia in women with bleeding disorders shows a continuing need for innovative treatments. This has led to development of this protocol in order to make available tranexamic acid as a potentially effective menorrhagia therapy option in women with an underlying bleeding disorder. We anticipate that Tranexamic Acid may be a beneficial choice for controlling menorrhagia in bleeding disorder patients.

Detailed description: Women with heavy periods and with a diagnosed bleeding disorders are prescribed cyclokapron pills to be taken during their periods. Their periods are assessed at 3 and 6 months by filling out a pictorial blood assessment chart. If the drug appears to be working with no adverse effects the patients can continue to take the medication as long as it is available with follow up with the investigator every 6 months.

Eligibility criteria: Inclusion Criteria:

* all menstruating women regardless of age
* Women with heavy periods as measured by pictorial blood assessment chart
* Women diagnosed with a bleeding disorder

Exclusion Criteria:

* Acquired defective color vision
* Factor VIII, Factor IX, FactorXI levels \>250%
* An inherited thrombophilic defect detected because of a positive family or personal history of thrombosis
* Current use of oral contraceptives

Primary outcomes:
measure: Reduced pictorial blood assessment chart scores from baseline
timeFrame: 3 and 6 months after start of medication
Secondary outcomes:
measure: increased hematocrit
timeFrame: 3 and 6 months from start of medication
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mary M. Gooley Hemophilia Center
state: New York
Study officials:
affiliation: Mary M. Gooley Hemophilia Center
name: Peter A Kouides, MD
role: PRINCIPAL_INVESTIGATOR
References: