louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06673784: Evaluation and Risk Factors of Post-traumatic Endophthalmitis
Official title: Evaluation and Risk Factors of Post-traumatic Endophthalmitis
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Endophthalmitis
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2024-11-05
Enrollment: 41
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Evaluation and risk factors of post-traumatic endophthalmitis with general and optical examination on patients exposed to eye trauma and developed post-traumatic endophthalmitis

Brief summary: 1. identify the incidence of post-traumatic endophthalmitis and the related risk factors influencing its development.
2. study the clinical- microbiological profile and evaluate the functional and anatomical outcomes of post-traumatic endophthalmitis (PPTE).


Eligibility criteria: Inclusion Criteria:

* Patients exposed to eye trauma and developed post-traumatic endophthalmitis

Exclusion Criteria:

* Patients who refuse to sign informed consent in this study

Primary outcomes:
measure: Knowledge of clinical features outcomes of post-traumatic endophthalmitis
timeFrame: Baseline
Secondary outcomes:
measure: The factors associated with a worse prognosis in post-traumatic endophthalmitis
timeFrame: Baseline
Other outcomes:
Locations:
Study officials:
References:
citation: Alfaro DV, Roth DB, Laughlin RM, Goyal M, Liggett PE. Paediatric post-traumatic endophthalmitis. Br J Ophthalmol. 1995 Oct;79(10):888-91. doi: 10.1136/bjo.79.10.888.
Clinical trial NCT00935779: Ultra Structure Of Peritoneum At Electronic Microscopy In Control Subjects And Patients With Gastric Cancer
Official title: Ultra Structure of Peritoneum at Electronic Microscopy in Control Subjects and Patients With Gastric Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Stomach Neoplasm
Keywords: Stomach Neoplasms
Peritoneum
Lead sponsor: University of Chile
Sponsor class: OTHER
First posted: 2009-07-09
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients with operable local gastric adenocarcinoma consulting to Hospital Clinico, University of Chile during study period.

Brief summary: Peritoneal metastases appear in a great proportion of patients affected by gastric carcinoma. Involved mechanisms are poorly understood though experimentally it has been demonstrated that neoplastic cells exfoliated from primary tumor can only implant and proliferate in areas of damaged peritoneum. Objectives: to study ultra-structure of peritoneal surface by electronic microscopy in control subjects and in patients with early or locally advanced gastric cancer looking for spontaneous changes in peritoneal surface not related with surgical injury.

Detailed description: 18 out of 32 cases were eligible for analysis. Four patients operated on for benign diseases served as control and 14 patients with operable local gastric adenocarcinoma (4 mucosa/submucosa/muscular y 10 serosa lesions) were studied. At the beginning of surgery, a 2 x 2 cm. sample from macroscopically normal visceral peritoneum at mesenterium root was carefully obtained, washed with saline and fixed in glutaraldehyde solution. Besides a sample of peritoneal washing fluid was studied to exclude patients with free cancer cells. Peritoneal tissue was fixed during 24 hours and then all samples were evaluated by electronic microscope.

Eligibility criteria: Inclusion Criteria:

* patients with operable local gastric adenocarcinoma

Exclusion Criteria:

* previous abdominal surgery
* previous open or blunt abdominal trauma
* history of inflammatory bowel disease or Typhoid Fever, Gallstone disease, chemotherapy or radiotherapy, or any other abdominal condition that could alter peritoneal integrity.
* All other gastric malignancies such as lymphomas, GIST, carcinoids

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Santiago
country: Chile
facility: Department of Surgery, Clinical Hospital, University of Chile
state: Region Metropolitana
Study officials:
affiliation: Department of Surgery, Clinical Hospital, University of Chile
name: Patricio Burdiles, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03284879: Post-Marketing Surveillance Study of OTEZLA
Official title: OTEZLA® Tablets Drug Use-Results Survey
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Psoriasis
Keywords: Psoriasis vulgaris
Psoriasis arthropathica
Serious infections
Gastrointestinal Disorders
Serious Hypersensitivity
Weight Decrease
Vasculitis
Malignancies
Depression and Suicidal Ideation
Lead sponsor: Amgen
Sponsor class: INDUSTRY
First posted: 2017-09-15
Enrollment: 1086
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients who have received a diagnosis of either of the following diseases and have received OTEZLA for the first time will be included in this survey.

* Psoriasis vulgaris that is with an inadequate response to topical therapies
* Psoriasis arthropathica

Brief summary: To evaluate the safety and efficacy of OTEZLA in actual clinical settings of use in patients with Psoriasis vulgaris that is with an inadequate response to topical therapies and Psoriasis arthropathica

1. Planned registration period 2 years
2. Planned surveillance period for 4 years from 6 months after launch


Eligibility criteria: Inclusion Criteria:

- Patients who have received a diagnosis of either of the following diseases and have received OTEZLA for the first time will be included in this survey.

* Psoriasis vulgaris that is with an inadequate response to topical therapies
* Psoriasis arthropathica

Exclusion Criteria:

* N/A

Primary outcomes:
measure: Adverse Events (AEs)
timeFrame: Up to approximately 12 months
measure: General Improvement Rating
timeFrame: Approximately 1 year from administration
measure: General health assessment on VAS
timeFrame: Approximately 1 year from administration
measure: Changes in physician general assessment
timeFrame: Approximately 1 year from administration
measure: Percentage of patients with Dermatology Life Quality Index (DLQI)
timeFrame: Approximately 1 year from administration
measure: Change from baseline activity for arthritis
timeFrame: Approximately 1 year from administration
Secondary outcomes:
Other outcomes:
Locations:
city: Kitakyushu
country: Japan
facility: Tugi dermatology clinic
state: Fukuoka
Study officials:
affiliation: Amgen
name: MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT03039179: Polyurethane Foam on the Heel for Prevention in Children
Official title: Effectiveness of Polyurethane Foam in Preventing the Onset of Pressure Sores in a Pediatric Orthopedic Population: Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Flat Foot
Pressure Ulcer
Lead sponsor: Istituto Ortopedico Rizzoli
Sponsor class: OTHER
First posted: 2017-02-01
Enrollment: 80
Sex: ALL
Minimum age (years): 3
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The post-operative treatment of pediatric patients operated for the correction of flat foot, sees today the use of preformed leg-foot splint (Walker) as an alternative to the application of plaster casts. The change of the immobilization system has led to the appearance of problems of tolerability in particular in the skin. The aim of the study is to assess whether by placing a polyurethane foam dress at the heel in the immediate postoperative period until removal of the Walker, the rate of skin lesion and pain is reduced.


Eligibility criteria: Inclusion Criteria:

* Children aged \> 3 years underwent surgery for flat foot
* Children with intact skin at the heel

Exclusion Criteria:

* Caregivers who cannot speak Italian
* Those who refuse to give their consent to take part in the study
* Patients with lower limb casts after surgery

Primary outcomes:
measure: Heel Pressure Sores (Numbers of Participants With Heel Pressure Sores)
timeFrame: every day until discharge (expected average of 3 days)
Secondary outcomes:
measure: Pain (Score on the "Numeric Rating Scale")
timeFrame: up to the first 3 days post intervention
Other outcomes:
Locations:
Study officials:
affiliation: Istituto Ortopedico Rizzoli
name: Caterina Guerra, RN
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00171379: Clinical Study to Evaluate the Tolerability, Safety and Efficacy of Enteric-coated Mycophenolate Sodium After Equimolar Conversion From Mycophenolate Mofetil (MMF) in Patients With Renal Transplant
Official title: Open-label Study to Evaluate the Tolerability, Safety and Efficacy of the Equimolar Conversion From Mycophenolate Mofetil (MMF) to Enteric-Coated Mycophenolate Sodium (EC-MPS) in Patients With Renal Transplant
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Prevention of Acute Rejection After Kidney Transplantation
Keywords: Kidney transplantation; acute rejection; gastrointestinal adverse events; quality of life; mycophenolate sodium.
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2005-09-15
Enrollment: 162
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The aim of the study is to evaluate the safety and efficacy of equimolar conversion from MMF to enteric-coated mycophenolate sodium, in renal transplant patients receiving cyclosporine.


Eligibility criteria: Inclusion Criteria:

* First or second (single or double) deceased or living donor kidney transplant received at least six months previously;

  * Immunosuppressive therapy with cyclosporin and mycophenolate mofetil (MMF);
  * Receiving an MMF dose of \<2/g/day because of any adverse event and/or altered laboratory test result attributed to MMF

Exclusion Criteria:

* • Subjects expected to discontinue cyclosporin therapy;

  * Patients with thrombocytopenia (\<75,000/mm3), an absolute neutrophil count of \<1,500/mm3 and/or leukopenia (\<2,500/mm3), or anemia (hemoglobin \<6 g/dl) at baseline;
  * Patients experiencing an acute rejection in the previous two months, with inadequate (creatininemia \>2.5 mg/dL) or worsening renal function in the previous two months.

Primary outcomes:
measure: Renal function, measured as calculated creatinine clearance according to the Cockcroft and Gault formula
Secondary outcomes:
measure: Incidence of biopsy proven acute rejection
measure: Overall Gastrointestinal disturbances as measured by visual analog scales (upper and lower gastrointestinal symptoms)
measure: Quality of life related to GI symptoms (GIQLI scale)
measure: Full blood count
measure: Gastrointestinal Adverse Events (check-list)
Other outcomes:
Locations:
Study officials:
affiliation: Novartis
name: Novartis
role: STUDY_DIRECTOR
References:
Clinical trial NCT06919679: Phase II Trial of BrECADD in HIV-Positive Patients With Advanced-Stage Classical Hodgkin Lymphoma
Official title: Phase II Trial of BrECADD in HIV-Positive Patients With Advanced-Stage Classical Hodgkin Lymphoma
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: Hodgkin Lymphoma (Category)
Keywords: advanced stage
HIV positive
Brentuximab Vedotin
Lead sponsor: University of Cologne
Sponsor class: OTHER
First posted: 2025-04-09
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Participants receive chemotherapy with BrECADD in standard doses and cycle length. After the first two cycles, a restaging is performed by contrast-enhanced computed tomography (ceCT) and PET (PET/CT) in order to guide response-adapted continuation of therapy consisting of 4 or only 2 additional cycles of BrECADD in case of a PET-positive or -negative staging result, respectively. A second restaging will be performed after completion of chemotherapy. In patients with PET-positive residual disease, local irradiation followed by another restaging is recommended. ART should be continued during chemotherapy.


Eligibility criteria: Inclusion Criteria:

* Histologically confirmed first diagnosis of cHL
* Advanced-stage disease: stage IIB with large mediastinal mass and/or extranodal lesions or stage III or IV
* No previous treatment for HL with the exception of steroid prephase
* Confirmed HIV infection with CD4 counts ≥ 150/μL at registration or \> 250/μL at any time within 8 months prior to HL diagnosis
* Continuation of antiretroviral treatment (ART) / Initiation of ART in patients who are ART-naive
* Age: 18-60 years

Exclusion Criteria:

* Previous malignancy during last 5 years or active malignancy, prior chemotherapy or radiotherapy which precludes protocol treatment
* Nodular lymphocyte-predominant Hodgkin lymphoma or composite lymphoma
* Multi-drug resistant HIV infection or concurrent AIDS-defining conditions
* Pregnancy or breastfeeding

Primary outcomes:
measure: Progression Free Survival
timeFrame: PFS at 1 year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05882279: A Survey on NINLARO Risk Management Plan (RMP) Material Utilization Among Pharmacists in Japan
Official title: Evaluation of the Effectiveness of Risk Minimization Measures: A Survey Among Pharmacists to Assess the Impact of the RMP Material for Patients on Promoting the Proper Use of NINLARO in Japan
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Multiple Myeloma
Keywords: Drug Therapy
Lead sponsor: Takeda
Sponsor class: INDUSTRY
First posted: 2023-05-31
Enrollment: 330
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: Pharmacists included in Nikkei Research Access Panel, active in clinical practice, and with valid contact details who belong to hospitals prescribing NINLARO and instructed the dosing of NINLARO in IRD therapy to patients with rrMM will be randomly selected to participate in the survey.

Brief summary: This is a survey among pharmacists who have instructed NINLARO therapy in ixazomib, lenalidomide and dexamethasone (IRD) dosing to patients with relapsed/refractory multiple myeloma (rrMM).

The main aims of the study are:

* To assess the frequency of pharmacists who have provided patients with the contents of the RMP material for patients.
* To assess the frequency of pharmacists who have obtained the RMP material for patients.
* To evaluate the depth of understanding of proper usage of NINLARO among pharmacists.

Detailed description: This is a prospective, non-interventional, observational web-based survey in pharmacists who have instructed the dosing of NINLARO (ixazomib) in combination with lenalidomide and dexamethasone therapy to patients with rrMM. The study will assess the effectiveness of distributed RMP material in prevention of ixazomib overdose in Japanese clinical practice.

The study will enroll approximately 300 pharmacists who belong to hospitals prescribing NINLARO. The data will be collected through a self-administered web-based survey with questionnaires provided in Japanese.

This web-based survey will be conducted in Japan.

Eligibility criteria: Inclusion criteria:

1. Who belong to hospitals prescribing NINLARO.
2. Who have instructed the dosing of NINLARO in IRD therapy to patients.

Exclusion criteria:

None

Primary outcomes:
measure: Number of Pharmacists Who Had Provided Patients With the Contents of the Risk Management Plan (RMP) Material
timeFrame: Up to Day 9
Secondary outcomes:
measure: Number of Pharmacists Who Had Received the RMP Material for Patients
timeFrame: Up to Day 9
measure: Number of Pharmacist With Understanding of the Proper NINLARO Dosing Schedule
timeFrame: Up to Day 9
measure: Number of Pharmacist With Understanding of the Importance of Providing NINLARO Dosing Schedule
timeFrame: Up to Day 9
Other outcomes:
Locations:
city: Tokyo
country: Japan
facility: Takeda selected site
Study officials:
affiliation: Takeda
name: Study Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT00004479: Randomized Study of Midodrine, an Alpha Adrenergic Agonist, in Patients With Neurally Mediated Syncope
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Syncope
Keywords: neurologic and psychiatric disorders
rare disease
syncope
Lead sponsor: Office of Rare Diseases (ORD)
Sponsor class: NIH
First posted: 1999-10-19
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Primary purpose: TREATMENT

Brief summary: OBJECTIVES:

Determine the efficacy of midodrine, a selective alpha 1 adrenergic agonist, in preventing neurally mediated syncope.

Detailed description: PROTOCOL OUTLINE: This is a randomized, double-blind, crossover, placebo-controlled study.

On day one, patients receive either midodrine or placebo. On day three, patients receive the opposite drug.

Eligibility criteria: PROTOCOL ENTRY CRITERIA:

--Disease Characteristics-- Diagnosis of neurally mediated syncope (vasovagal fainting) Sudden fall in blood pressure AND Slowing of the heart AND Temporary loss of consciousness AND Hemodynamic response to head up tilt --Prior/Concurrent Therapy-- No other concurrent adrenergic agonist or antiagonist --Patient Characteristics-- Fertile patients must use effective birth control

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Mount Sinai School of Medicine
state: New York
Study officials:
affiliation: Icahn School of Medicine at Mount Sinai
name: Horacio Kaufmann
role: STUDY_CHAIR
References:
Clinical trial NCT02170779: Developing and Testing a Comprehensive MS Spasticity Management Program
Official title: Developing and Testing a Comprehensive MS Spasticity Management Program
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Multiple Sclerosis
Spasticity
Keywords: multiple sclerosis
spasticity
stretching
exercise
rehabilitation
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
Collaborators: name: Oregon Health and Science University
First posted: 2014-06-23
Enrollment: 40
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: This is a study to determine the impact of education and specific lower extremity stretches for MS-related spasticity. The study will evaluate the acceptance and efficacy of education and stretching using a randomized controlled pilot trial.

Detailed description: Participants have 2-4 visits depending on program assignment. All participants will have screening/baseline and follow-up visits. Participants in the intervention program will have 2 additional visits with a group of other people with MS to view and discuss the DVDs on spasticity education and stretching for lower extremity MS spasticity and then practice the stretching exercises learned. They will be asked to track exercise electronically and on paper for 4 weeks. Participants will be compensated for participation.

Eligibility criteria: Inclusion Criteria:

Diagnosis of definite MS

* At least 18 years old
* Able to walk 25 feet independently with common assistive devices if needed
* Presence of spasticity by self-report interfering with usual daily activities
* Have an email account and be familiar with using it
* Willing to track daily exercise for 4 weeks
* Fluent in English

Exclusion Criteria:

Other medical or behavioral conditions that would limit participation or completion of the study.

Primary outcomes:
measure: MS Walking Scale-12 (MSWS-12)
timeFrame: at average of 4 months
Secondary outcomes:
measure: Timed 25 Foot Walk
timeFrame: at average of 4 months
measure: Timed up and go Test
timeFrame: at average of 4 months
measure: 2 Minute Walk Test
timeFrame: at average of 4 months
measure: Modified Fatigue Impact Scale (MFIS)
timeFrame: at average of 4 months
measure: Multiple Sclerosis Impact Scale (MSIS-29)
timeFrame: at average of 4 months
measure: Spasticity Measured by the Modified Ashworth Scale
timeFrame: at average of 4 months
measure: Multiple Sclerosis Spasticity Scale - 88 (MSSS-88)
timeFrame: at average of 4 months
measure: Beck Depression Inventory II (BDI II)
timeFrame: at average of 4 months
Other outcomes:
Locations:
city: Portland
country: United States
facility: VA Portland Health Care System, Portland, OR
state: Oregon
Study officials:
affiliation: VA Portland Health Care System, Portland, OR
name: Lucinda L Hugos, MS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04809779: PD-1 Inhibitor Concurrent With Chemotherapy as Neoadjuvant Therapy for TNBC
Official title: PD-1 Inhibitor Sintilimab Concurrent With Epirubicin Cyclophosphamide and Nab-paclitaxel as Neoadjuvant Therapy for Triple Negative Breast Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Triple Negative Breast Cancer
Lead sponsor: First Affiliated Hospital, Sun Yat-Sen University
Sponsor class: OTHER
First posted: 2021-03-22
Enrollment: 49
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to address the following hypotheses: the PD-1 inhibitor Sintilimab 200mg for intravenous (IV) administration will be given together with three-week epirubincin, cyclophosphamide (EC) × 4 treatments from the second cycle followed by weekly nab-paclitaxel x12 treatments or three-week nab-paclitaxel x4 treatments. This regimen will induce higher pathologic complete response (pCR) rate in triple negative breast cancer than historical pCR rates (30-40%) observed with chemotherapy alone.


Eligibility criteria: Inclusion Criteria:

* Newly diagnosed histologically confirmed stage I-III, ER, PR and HER2 negative invasive breast cancer as defined by the ASCO CAP guidelines for whom systemic chemotherapy would be indicated based on physician judgment following standard NCCN practice guidelines.

Exclusion Criteria:

* Patients for whom anthracycline, nab-paclitaxel or antibody therapies are contraindicated.

Primary outcomes:
measure: Pathologic Complete Response (pCR)
timeFrame: 21 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: The First Affiliated Hospital of Sun Yat-sen University
Study officials:
References: