louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05304949: Regulatory PMS Study for Lucentis® in Patients With Retinopathy of Prematurity
Official title: Regulatory Post-Marketing Surveillance(PMS) Study for Lucentis®(Ranibizumab) in Patients With Retinopathy of Prematurity
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Retinopathy of Prematurity
Keywords: Retinopathy of Prematurity
NIS
Post-Marketing Surveillance
Lucentis
Ranibizumab
Korea
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2022-03-31
Enrollment: 71
Sex: ALL
Minimum age (years): 0
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Korean patients who are prescribed with Lucentis® (Ranibizumab) injection in ROP indication

Brief summary: This study is an open-labeled, multicenter, single arm, observational post-marketing surveillance study under routine clinical practice with no mandated treatments, visits or assessments.

Detailed description: The investigators will collect safety information and evaluate effectiveness in patients who are prescribed with Lucentis® (Ranibizumab) injection in Retinopathy of Prematurity indication after receiving informed consent over a period of 4 weeks.

Subjects who received multiple doses, i.e., 2 or more doses, of Lucentis® injection will be defined as subjects with long-term use, and the safety and effectiveness information of up to 12 weeks will be collected and analyzed separately.

Eligibility criteria: Inclusion Criteria:

1. Premature infants with retinopathy of prematurity (ROP)
2. Patients (infants) prescribed with Lucentis® injection according to the product approval information in the Republic of Korea
3. In the case that the legal guardian of the patient (infant) provided a written consent to participate in this study

Exclusion Criteria:

1. In the case that the legal guardian of the patient (infant) does not want participation in this study
2. In the case that it falls under any of the contraindications listed in local prescribing information of Lucentis® injection

   * Patients with hypersensitivity to the active substance or to any of the excipients
   * Patients with an active or suspected ocular or periocular infection.
   * Patients with active intraocular inflammation

Primary outcomes:
measure: Incidence of adverse events/adverse drug reactions
timeFrame: Up to 12 weeks
Secondary outcomes:
measure: Proportion of treatment success
timeFrame: Up to 12 weeks
Other outcomes:
Locations:
city: Daegu
country: Korea, Republic of
facility: Novartis Investigative Site
state: Dalseo Gu
city: Seoul
country: Korea, Republic of
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References:
Clinical trial NCT06980649: Study of BHV-1300 in Graves' Disease
Official title: An Open-Label Biomarker Study of BHV-1300 in Graves' Disease
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Graves Disease
Keywords: Autoimmune thyroid disease
hyperthyroidism
anti thyroid drug
thyroid disease
autoimmune diseases
endocrine system diseases
Lead sponsor: Biohaven Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
First posted: 2025-05-20
Enrollment: 15
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: The purpose of this study is to determine if BHV-1300 is a safe and effective treatment in participants with Graves' Disease.


Eligibility criteria: Key Inclusion Criteria:

1. Participants must have serologically confirmed Graves' Disease.
2. Participants must have active hyperthyroidism due to Graves' Disease.

Key Exclusion Criteria:

1. History of hyperthyroidism not caused by Graves' Disease (e.g., toxic adenoma or toxic multinodular goiter) and/or history of thyroid storm within six weeks of the Baseline visit.
2. History of treatment with radioactive iodine or thyroid surgery.

Primary outcomes:
measure: Proportion of participants with normalization of T3 and T4
timeFrame: Baseline to Week 12
Secondary outcomes:
measure: Number of participants with Serious AEs (SAEs), AEs leading to discontinuation, deaths
timeFrame: Baseline to Week 12
measure: Number of participants with Grade 3-4 (CTCAE/DAIDS) treatment-emergent laboratory abnormalities.
timeFrame: Baseline to Week 12
Other outcomes:
Locations:
city: Kotara
country: Australia
facility: Site-001
Study officials:
References:
Clinical trial NCT02658149: Psoas Compartment Block Versus Periarticular Local Anesthetic for Total Hip Arthroplasty
Official title: Psoas Compartment Block Versus Periarticular Local Anesthetic Infiltration for Pain Management for Total Hip Arthroplasty: A Prospective, Randomized Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Osteoarthritis
Arthroplasty
Lead sponsor: William Beaumont Hospitals
Sponsor class: OTHER
First posted: 2016-01-18
Enrollment: 100
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: The primary objective of this study is to examine whether there is a difference in the level of resting pain following total hip arthroplasty with an anterior approach with use of a psoas compartment block versus a local periarticular anesthetic infiltration

Detailed description: A single-center, prospective, randomized clinical trial with a total of 100 patients. One orthopaedic adult reconstruction surgeon at Beaumont Hospital Royal Oak (JJV) will perform all surgeries. After the patient has consented they will be randomized to one of the following two groups:

1. Psoas compartment block (n=50)
2. Periarticular local anesthetic infiltration (n=50),

The patient will be blinded to the study group.

Eligibility criteria: Inclusion Criteria:

* Patients undergoing unilateral primary total hip arthroplasty by Dr. James Verner at Beaumont Hospital Royal Oak
* Have a diagnosis of primary osteoarthritis (i.e. degenerative joint disease)
* Surgical approach is anterior

Exclusion Criteria:

* Minors (age less than 18 years)
* Pregnant (surgically sterile, post-menopausal, or negative blood test)
* Previous ipsilateral hip surgery
* Lumbar instrumentation
* Acute trauma
* Rheumatoid arthritis
* Avascular necrosis
* Hip dysplasia
* Known sensitivity, allergy, or contraindication to anesthetics being used in the study
* Narcotic sensitivity
* History of over 6 months of opioid dependency prior to surgery (excluding tramadol)
* Peripheral neuropathy
* Mental/cognitive impairment that would interfere with the patient's self-assessments of function, pain, or quality of life

Primary outcomes:
measure: Pain Score at 3 Hours
timeFrame: 3 hours postoperative
Secondary outcomes:
measure: Pain Score at 3-24 Hours
timeFrame: measured once during time frame 3 hours-24 hours postoperative
measure: Pain Score at 24-48 Hours
timeFrame: measured once during time froma 24-48 hours postoperative
measure: Opioid Usage In-hospital at 24 Hours
timeFrame: 24 hours postoperatively
measure: Opioid Usage In-hospital at 48 Hours
timeFrame: 48 hours postoperatively
Other outcomes:
Locations:
city: Royal Oak
country: United States
facility: Beaumont Hospital
state: Michigan
Study officials:
affiliation: William Beaumont Health
name: James Verner, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00892749: Long-term Study in Patients With Chronic Kidney Disease and Hyperphosphatemia on Hemodialysis
Official title: A Phase 3, Long-term Study in Patients With Chronic Kidney Disease (CKD) and Hyperphosphatemia on Hemodialysis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Chronic Kidney Disease
Renal Dialysis
Renal Insufficiency
Hyperphosphatemia
Keywords: hyperphosphatemia
hemodialysis
CKD
ASP1585
Lead sponsor: Astellas Pharma Inc
Sponsor class: INDUSTRY
First posted: 2009-05-04
Enrollment: 248
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a multi-center, open-labeled, non-comparative study to examine the safety and efficacy of ASP1585 for long-term dosing in chronic kidney disease and hyperphosphatemia patients on hemodialysis.


Eligibility criteria: Inclusion Criteria:

* Chronic kidney disease patients on hemodialysis
* Hyperphosphatemia
* Written informed consent

Exclusion Criteria:

* Patients with gastrointestinal surgery or enterectomy
* Severe cardiac disease patients
* Patients with severe constipation or diarrhea
* Patients with a complication of malignant tumors
* Patients with uncontrolled hypertension
* Patients treated with parathyroid intervention

Primary outcomes:
measure: Changes in serum Phosphorus level
timeFrame: After 48 weeks
Secondary outcomes:
measure: Percent of the patients meeting the target range of serum Phosphorus levels
timeFrame: During the treatment
measure: Changes in serum Calcium level
timeFrame: After 48 weeks
measure: Changes in serum Ca x P
timeFrame: After 48 weeks
measure: Changes in intact PTH level
timeFrame: After 48 weeks
Other outcomes:
Locations:
city: Chubu
country: Japan
city: Chugoku
country: Japan
city: Kansai
country: Japan
city: Kantou
country: Japan
Study officials:
affiliation: Astellas Pharma Inc
name: Use Central Contact
role: STUDY_CHAIR
References:
Clinical trial NCT03533049: mHealth Family Self-Management
Official title: mHealth Family Self-Management Intervention for Parents of Transplanted Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Transplantation
Pediatric ALL
Lead sponsor: Medical College of Wisconsin
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
First posted: 2018-05-22
Enrollment: 67
Sex: ALL
Maximum age (years): 100
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: This innovative research will address a gap in the literature involving the evaluation of the impact of an individualized family-centered mHealth application to enhance daily post-discharge communication following pediatric transplant. This proposal lays the foundation for future research with myFAMI (self-management intervention) at multiple pediatric transplant centers and builds the science from which to consider post discharge monitoring and decrease cost of care in other pediatric chronic illness populations.


Eligibility criteria: Inclusion Criteria:

Pediatric patients:

1. Has undergone a heart, kidney, or liver transplant being discharged home from the hospital
2. Has two eligible family members available to answer questions about the patient

Family members will be eligible for participation upon meeting the following inclusion criteria:

1. is English speaking (to date the instruments being used have been validated for English speaking participants only)
2. is 18 years of age or older
3. has a pediatric family member (\< 18 years old) who has undergone a heart, kidney, or liver transplant being discharged home from the hospital.

Exclusion Criteria for the family members are:

1. presence of significant communication or cognitive impairment that would preclude completion of questionnaires based on self-report; or
2. the pediatric family member has experienced a previous transplant based on self report.

Participants unable to speak and read English will be excluded due to the lack of resources to develop the app and communicate via FaceTime in different languages. We will recruit family members from three types of transplant populations to allow for sufficient sample in a limited time frame for this complex pediatric surgery and high-risk population.

-

Primary outcomes:
measure: Improve family coping
timeFrame: 30 days
Secondary outcomes:
measure: Decrease healthcare resources
timeFrame: 30 days
Other outcomes:
Locations:
city: Milwaukee
country: United States
facility: Children's Hospital of Wisconsin
state: Wisconsin
Study officials:
affiliation: Medical College of Wisconsin
name: Stacee Lerret, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lerret SM, Flynn E, White-Traut R, Alonso E, Mavis AM, Jensen MK, Peterson CG, Schiffman R. Acceptability of an mHealth Family Self-management Intervention (myFAMI) for Pediatric Transplantation Families: Qualitative Focus. JMIR Nurs. 2022 Jul 15;5(1):e39263. doi: 10.2196/39263.
Clinical trial NCT04817449: Spectroscopy in Ovarian Cancer
Official title: Molecular Spectroscopy in Identification and Assessment of Ovarian Cancer
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Ovarian Cancer
Ovarian Neoplasms
Ovary Cyst
Ovary Disease
Lead sponsor: University of Exeter
Sponsor class: OTHER
Collaborators: name: University Hospitals Bristol and Weston NHS Foundation Trust
First posted: 2021-03-26
Enrollment: 160
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients presenting to secondary care with suspected ovarian cancer symptoms. Patients with likely ovarian cancer, yet to start definitive treatment.

Brief summary: Ovarian cancer is the eighth most common cause of cancer death in the world. Advanced stage at diagnosis is associated with lower survival rates, thus early detection appears to have an important role.

Raman Spectroscopy is a non-invasive technique that uses the interaction of light to identify the composition of the sample tested.

The aim of the project is to explore the use of spectroscopic techniques in the detection of ovarian cancer. There are two different assessments within the project:

1. Identify ovarian cancer in blood - Raman spectroscopic analysis will be performed on blood plasma taken from patients with suspected ovarian cancer.
2. Detect active cancer within post chemotherapy fibrotic tissue - Ex vivo Raman spectroscopic analysis of peritoneal, omental or ovarian tissues collected from patients undergoing surgical treatment for ovarian cancer.

The results of the spectroscopy will be correlated to clinical outcome and histological diagnosis respectively.


Eligibility criteria: Inclusion Criteria:

* Female
* Symptoms suggestive of ovarian cancer
* Patients undergoing treatment of Ovarian Cancer

Exclusion Criteria:

* Less than 18 years of age
* Unable to consent to the study due to communication difficulties
* Unable to consent to the study due to lack of capacity

Primary outcomes:
measure: Ascertain the diagnostic performance of vibrational spectroscopy for detection of Ovarian Cancer
timeFrame: 2 years
measure: Ascertain the discriminatory ability of vibrational spectroscopy to differentiate between normal, fibrotic and cancerous tissue
timeFrame: 2 years
Secondary outcomes:
measure: Performance of vibrational spectroscopy in chemotherapy response prediction
timeFrame: 2 years
measure: Performance of vibrational spectroscopy in recurrence prediction
timeFrame: 2 years
Other outcomes:
Locations:
city: Bristol
country: United Kingdom
facility: University Hospitals Bristol and Weston NHS Trust
Study officials:
References:
Clinical trial NCT02036749: Ultrasound-guided Quadratus Lumborum Block for Postoperative Pain Relief After Cesarean Delivery
Official title: Ultrasound-guided Quadratus Lumborum Block for Postoperative Pain Relief After Cesarean Delivery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postoperative Pain
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
First posted: 2014-01-15
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: The Quadratus Lumborum (QL) Block is an ultrasound-guided technique described by Rafael Blanco in 2007. The nerves to the lower abdominal wall can be anesthetized by injecting local anesthetics close to the anterior border of the quadratus lumborum muscle. In our randomized, controlled, double-blinded study ultrasound-guided QL-blocks in 20 female patients after cesarean delivery will be compared with a placebo control group of 20 patients to investigate analgesic consumption, pain level, opioid related side effects and mobilization.


Eligibility criteria: Inclusion Criteria:

* Patients with cesarean delivery
* American Society of Anesthesiologists classification (ASA) \< 3
* adequate communication skills
* Body mass index \< 32

Exclusion Criteria:

* ASA \> 2
* chronic pain
* neurological illness/ neuropathy
* contraindication against local anesthetics

Primary outcomes:
measure: morphine consumption
timeFrame: 48 hours
Secondary outcomes:
measure: pain level (NRS)
timeFrame: 48 hours
Other outcomes:
measure: time to mobilization
timeFrame: 48 hours
Locations:
city: Oslo
country: Norway
facility: Oslo University Hospital
Study officials:
affiliation: Oslo University Hospital
name: Anders Krohg, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00740649: Single Ascending Dose Study of the Safety, Tolerability, Pharmacokinetics (PK), and Pharmacodynamics (PD) of HSD-016
Official title: Single Ascending Dose Study Of The Safety, Tolerability, Pharmacokinetics, And Pharmacodynamics Of HSD-016 Administered Orally To Healthy Japanese Male Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Subjects
Lead sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
Sponsor class: INDUSTRY
First posted: 2008-08-25
Enrollment: 74
Sex: MALE
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a single ascending dose study of HSD-016 to provide the initial assessment of the safety, tolerability, how the drug is absorbed and eliminated, and it's effect on the body in Japanese male subjects.


Eligibility criteria: Inclusion:

1. Men, aged 20 to 45 years inclusive at screening.
2. Body mass index (BMI) in the range of 17.6 to 26.4 kg/m2 and body weight ≥45 kg
3. Healthy as determined by the investigator on the basis of screening evaluations.
4. Nonsmoker or smoker of fewer than 10 cigarettes per day as determined by history.

Exclusion:

1. No presence or history of any disorder that may prevent the successful completion of the study.
2. No history of drug abuse within 1 year.

Primary outcomes:
measure: clinical labs, adverse events
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Toshima-ku
country: Japan
state: Tokyo
Study officials:
affiliation: Wyeth is now a wholly owned subsidiary of Pfizer
name: Medical Monitor
role: STUDY_DIRECTOR
References:
Clinical trial NCT02581449: Effect of Omega-3 Fatty Acids on Oxidative Stress and Dyslipidemia in Pediatric Patients Undergoing Hemodialysis
Official title: Evaluation of the Effect of Omega-3 Fatty Acids Supplementation on Pediatric Patients Undergoing Hemodialysis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: End Stage Renal Disease
Keywords: omega-3 fatty acids
hemodialysis
oxidative stress
dyslipidemia
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2015-10-21
Enrollment: 50
Sex: ALL
Minimum age (years): 8
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to evaluate the effect of omega-3 fatty acids supplementation on pediatric patients undergoing hemodialysis via the measurement of the following before and after omega-3 administration:oxidative stress markers, inflammatory markers and serum lipids.


Eligibility criteria: Inclusion Criteria:

* Patients between 8 and 18 years old
* Patients treated with HD for at least 6 months

Exclusion Criteria:

* Patients with malignancy and active inflammatory disease.
* Patients who received vitamin E or any antioxidant treatment during the past 3 months.

Primary outcomes:
measure: effect on oxidative stress status via measurement of superoxide dismutase and glutathione peroxidase and malondialdehyde
timeFrame: four months
Secondary outcomes:
measure: effect on serum lipid levels (HDL cholesterol, LDL cholesterol, total cholesterol, and triglycerides)
timeFrame: four months
Other outcomes:
measure: effect on inflammation via measurement of C- Reactive Protein
timeFrame: four months
measure: effect on nitric oxide (serum concentration)
timeFrame: four months
Locations:
Study officials:
affiliation: university
name: Ain Shams
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02450149: Single-arm Study to Evaluate the Safety and Efficacy of Sorafenib, in Subjects With BRAF Mutation Refractory Solid Tumors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Refractory Solid Tumors
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
First posted: 2015-05-21
Enrollment: 1
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a pilot study of sorafenib in patients with BRAF Mutation Refractory Solid Tumors.

This study is a single-arm, pilot study of sorafenib in patients with Refractory Solid Tumors harboring BRAF Mutation Sorafenib 400 mg will be administered orally twice a day for 28 days.

To investigate the efficacy of sorafenib in patients with Refractory Solid Tumors harboring BRAF Mutation.


Eligibility criteria: Inclusion Criteria:

1. Provision of fully informed consent prior to any study specific procedures.
2. Patients must be ≥20 years of age.
3. BRAF mutation Refractory Solid Tumors that has recurred or progressed following standard therapy, or that has not responded to standard therapy, or for which there is no standard therapy.
4. ECOG performance status 0-2.
5. Have measurable or evaluated disease based on RECIST1.1. as determined by investigator.
6. Adequate Organ Function Laboratory Values

   * Absolute neutrophil count ≥ 1.5 x 109/L, Hemoglobin ≥ 9g/dL, Platelets ≥ 100 x 109/L
   * bilirubin ≤ 1.5 x upper limit of normal AST/ALT ≤ 2.5 x upper limit of normal (5.0 X upper limit of normal , for subjects with liver metastases)
   * creatinine ≤1.5 x UNL
7. Patients of child-bearing potential should be using adequate contraceptive measures (two forms of highly reliable methods) should not be breast feeding and must have a negative pregnancy test prior to start of dosing.
8. Adequate heart function.

Exclusion Criteria:

1. Patients with second primary cancer, except: adequately treated non-melanoma skin cancer, curatively treated in-situ cancer of the cervix, or other solid tumours curatively treated with no evidence of disease for ≤3 years.
2. Has known active central nervous system (CNS) metastases.
3. Has an active infection requiring systemic therapy.
4. Pregnancy or breast feeding
5. Patients with cardiac problem.
6. Any previous treatment with sorafenib

Primary outcomes:
measure: progression-free survival
timeFrame: expected average of 24 weeks
Secondary outcomes:
measure: objective response rate
timeFrame: expected average of 24 weeks
measure: Time to progression
timeFrame: expected average of 24 weeks
measure: overall survival
timeFrame: expected average of 24 weeks
measure: Number of subjects with Adverse Events as a measure of toxicity profile
timeFrame: expected average of 24 weeks
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
state: seoul, korea, Republic of
Study officials:
References: