louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02230761: Phase 2 Study of XAF5 (XOPH5) Ointment for Reduction of Excess Eyelid Fat (Steatoblepharon)
Official title: A Phase 2, Randomized, Double-masked, Placebo-controlled Study of XOPH5 Ointment for Reduction of Lower Lid Steatoblepharon
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Lower Eyelid Steatoblepharon (Excess Eyelid Fat)
Keywords: steatoblepharon
blepharoptosis
dermatochalasis
blepharoplasty
periorbital
orbital
eyelid
eyebags
eye bags
Lead sponsor: Topokine Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2014-09-03
Enrollment: 90
Sex: ALL
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will test whether XAF5 (XOPH5) ointment, applied once daily to the lower eyelids for 10 weeks, reduces the prominence of lower eyelid fat in adults with moderate to severe steatoblepharon (excess eyelid fat).


Eligibility criteria: Inclusion Criteria (abbreviated):

* Moderate to severe lower eyelid steatoblepharon (LESS score of 2-4 bilaterally)
* Men and women 40-70 years old
* Healthy facial skin
* Must understand and provide informed consent

Exclusion Criteria (abbreviated):

* Best corrected visual acuity worse than 20/40 in either eye
* Regular use of ophthalmic medication in either eye
* Planned use of contact lenses during the study
* Any history of lower eyelid surgery

Primary outcomes:
measure: Lower Eyelid Steatoblepharon Severity (LESS) Score--Clinician-Reported
timeFrame: 11 weeks
Secondary outcomes:
Other outcomes:
measure: Patient Satisfaction Scale 1 (PSS1)
timeFrame: 0-11 weeks
measure: Patient Satisfaction Scale 2 (PSS2)
timeFrame: 11 weeks
Locations:
city: Boston
country: United States
facility: Topokine Therapeutics Clinical Study Centers
state: Massachusetts
Study officials:
affiliation: Topokine Therapeutics, Inc.
name: Michael S. Singer, MD, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT00415961: Multi-Center Clinical Trial: Evaluation of Effectiveness and Safety
Official title: Multi-Center Clinical Trial: Evaluation of Effectiveness and Safety
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Coronary Disease
Keywords: Percutaneous Coronary Intervention (PCI)
Drug-eluting stent (DES)
Lead sponsor: Conor Medsystems
Sponsor class: INDUSTRY
Collaborators: name: Getz Pharma
First posted: 2006-12-27
Enrollment: 120
Sex: ALL
Minimum age (years): 20
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This trial aims to demonstrate the non-inferiority of the CI-CMS-005 Coronary Stent System to the study device as well as to the TAXUS™ Express2™ Drug-Eluting Coronary Stent System in in-segment late lumen loss at 9 months after treatment of a single de novo lesion per vessel.

Detailed description: This is a complementary, multi-center, open-label, single-arm trial investigating angiographic and clinical patient outcomes in Japan. Historical data from the 2-arm randomized COSTAR II trial will be used for comparison.

Eligibility criteria: Inclusion Criteria:

General Inclusion Criteria

* Eligible for percutaneous coronary intervention (PCI)
* Documented stable or unstable angina pectoris (Class I, II, III or IV), documented ischemia, or documented silent ischemia
* Documented LVEF ≥25% within the last 6 weeks.
* Eligible for coronary artery bypass graft surgery (CABG)

Exclusion Criteria:

General Exclusion Criteria: -

* Known sensitivity to paclitaxel or polymeric matrices.
* Planned treatment with any other PCI device in the target vessel(s).
* MI within 72 hours prior to the index procedure
* Patient is in cardiogenic shock
* Cerebrovascular Accident (CVA) within the past 6 months
* Acute or chronic renal dysfunction (creatinine \>2.0 mg/dl or \>150 µmol/L)
* Contraindication to ASA or to ticlopidine
* Thrombocytopenia
* Active GI bleeding within past three months
* Known allergy to cobalt chromium
* Any prior true anaphylactic reaction to contrast agents

Primary outcomes:
measure: In-segment late lumen loss at 9 months, as measured by QCA.
timeFrame: 9 months
Secondary outcomes:
measure: Device, lesion and procedure success; MACE at 30 days and 8 months, Angiographic restenosis at 9 months; Clinically driven Target Lesion Revascularization at 8 months
timeFrame: MACE at 30 days and 8 months, Angiographic restenosis at 9 months; Clinically driven Target Lesion Revascularization at 8 months
Other outcomes:
Locations:
city: Kamakura City
country: Japan
facility: Shonan Kamakura General Hospital
Study officials:
affiliation: ShonanKamakura General Hospital
name: Shigeru Saito, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06016361: Evaluation of a Novel Amino Acid Based Moisturizing Cream as Part of the Daily Standard Skincare Regimen Recommended During Radiation Therapy
Official title: Evaluation of a Novel Amino Acid Based Moisturizing Cream as Part of the Daily Standard Skincare Regimen Recommended During Radiation Therapy
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Erythema
Radiation Therapy, Secondary Skin Reactions
Lead sponsor: Entrinsic Bioscience Inc.
Sponsor class: INDUSTRY
First posted: 2023-08-29
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The goal of this clinical study is to evaluate a novel amino acid based moisturizing cream as part of the daily standard skincare regimen recommended during radiation therapy. The main aim of this study is to assess if the investigational product can improve skin redness associated with radiation therapy. Participants will apply a moisturizer daily during the course of their prescribed radiation therapy for breast cancer. Researchers will compare against the standard of care.


Eligibility criteria: Inclusion Criteria:

* Provision of signed and dated informed consent form.
* Aged over 18 years old.
* Has been diagnosed with breast cancer and prescribed radiotherapy as a part of their cancer treatment.
* Planned radiotherapy, as prescribed by the oncologist, is expected to provide a total radiation dose of up to 60 gray within the first 4 weeks of treatment.
* Be able to adhere to proposed daily wound/site care as proposed by the protocol in line with the AADs recommendations.

Exclusion Criteria:

* Pre-existing skin conditions which in the opinion of the investigator could impact on the integrity of the study or compromise the safety of the patient (i.e., active eczema, psoriasis, or an open wound over the planned site of radiation).
* Have a concurrent medical condition or poor functional baseline which in the opinion of the investigator would make them unsuitable or able to fully comply with the study protocol.
* Are pregnant or actively breast feeding.
* Known allergic reactions to ingredients of the Investigational Product or the Standard of Care.

Primary outcomes:
measure: Reduction in Erythema
timeFrame: Up to 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Fort Myers
country: United States
facility: Advocate Radiation Oncology
state: Florida
Study officials:
References:
Clinical trial NCT05641961: Mobile App to Help Survivors of Childhood Cancer Navigate Long-Term Follow-Up Care
Official title: Utilizing a Mobile App to Help Survivors of Childhood Cancer Navigate Long-Term Follow-Up Care
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Childhood Cancer
Hematopoietic and Lymphoid Cell Neoplasm
Malignant Solid Neoplasm
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: Swim Across America
First posted: 2022-12-08
Enrollment: 30
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This clinical trial studies the effectiveness of a newly developed survivorship mobile application (app) designed for survivors, or their caregivers, of childhood cancer to help them better navigate long-term follow-up care. The survivorship app provides survivors access to their treatment history and follow-up recommendations, improves knowledge of their diagnosis, treatment, risks, and recommended follow-up care by using a message notification. The ability to quickly connect and establish care planning may enhance adherence to recommended follow-up.

Detailed description: PRIMARY OBJECTIVE:

I. To determine the difference in survivor/caregiver knowledge and understanding of diagnosis, treatment information, and follow-up needs using the survivorship app.

SECONDARY OBJECTIVE:

I. To validate the usability and effectiveness of the survivorship mobile application.

OUTLINE:

Participants are seen in the survivorship clinic and receive education about potential late effects and the survivorship application on study. Participants then use the survivorship app for 4 months on study.

Eligibility criteria: Inclusion Criteria:

* Survivors of childhood cancer attending Survivorship Clinic at University of California, San Francisco (UCSF) OR caregivers of a childhood cancer survivor attending Survivorship Clinic at UCSF.
* Must have a mobile device (smartphone or smart-tablet) with service plan.
* Must have ability to read, write, and understand English language.

Exclusion Criteria:

* An individual who does not meet any of the criteria mentioned above will be excluded from participation in this study.

Primary outcomes:
measure: Change in knowledge questionnaire score
timeFrame: Up to 4 months
Secondary outcomes:
measure: System usability scale (SUS) score > 68
timeFrame: Up to 2 months
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: Robert Goldsby, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00510861: Influence of Paternal Age on Assisted Reproduction Outcome
Official title: Influence of Paternal Age on Assisted Reproduction Outcome
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: We Will Retrospectively Assess Our Databases in Our Clinic
Instituto Valenciano de Infertilidad in Valencia (Spain)
Searching for Assisted Reproduction Procedures
IUI Standard IVF/ICSI Cycles and Ovum Donation IVF/ICSI Cycles
Who Were Referred to Our Unit to Cryopreserve Sperm During the Period
From January 2000 to December 2006
Keywords: male age, assisted reproduction, sperm, pregnancy outcome
Lead sponsor: Instituto Valenciano de Infertilidad, IVI VALENCIA
Sponsor class: OTHER
First posted: 2007-08-02
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: RETROSPECTIVE

Brief summary: In the recent years, there is an increasing tendency to the parenthood delay in developed countries, and there is not enough information available regarding the influence of the male's age on fertility. If any, the negative impact should be acting at advanced ages.

Our aim with this work was to determine the role of paternal age on IUI results embryo quality and IVF outcome. Evenmore, in order to standardize the female factor, good quality oocytes (from fertile oocyte donors) and only first IVF cycles in young women were considered.

Detailed description: A retrospective study has been designed with a total number of 2204 IUI, 1286 IVF cycles and 1412 IVF cycles with donated oocytes from 2000 to 2006.

The inclusion criteria will be for IUI: women under 38 years old, tubal patency demonstrated by hysterosalpingography, normal uterine scan, normal basal hormonal levels, body mass index \< 27 kg/m2, and absence of polycystic ovarian syndrome and endometriosis. For normal IVF cycles and oocyte donation cycles only first cycles will be analyzed. Cycles will be studied only in couples with absence of severe male factor.

Eligibility criteria: Inclusion Criteria:

* women under 38 years old, tubal patency demonstrated by hysterosalpingography, normal uterine scan, normal basal hormonal levels, body mass index \< 27 kg/m2.

Exclusion Criteria:

* absence of polycystic ovarian syndrome, hydrosalpinx or endometriosis.
* Cycles were studied only in couples with absence of severe male factor.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Valencia
country: Spain
facility: IVI
Study officials:
affiliation: IVI Valencia
name: Marcos Meseguer, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05020483: FEIBA to Optimize Postcardiopulmonary Bypass Hemostasis in Pediatric Cardiac Patients
Official title: Activated Prothrombin Complex Concentrate FEIBA to Optimize Postcardiopulomonary Bypass Hemostasis in Pediatric Cardiac Patients
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Cardiac Disease
Keywords: Cardiac Surgery
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2021-08-25
Enrollment: 0
Sex: ALL
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this research is to understand if the medication called FEIBA helps to stop bleeding and decrease transfusion of blood products to small children operated on the heart.


Eligibility criteria: Inclusion Criteria:

* Weight ≤ 15 kg.
* Elective cardiac surgery with cardiopulmonary bypass.
* Coagulopathic bleeding after cardiopulmonary bypass.
* Availability and willingness of the parent/legal guardian to provide informed consent.

Exclusion Criteria:

* Presence of mechanical circulatory support at the time of randomization or POD 0 and 1.
* Patient or family history of coagulopathy and/or thromboses.
* Preoperative anticoagulation (excluding low dose heparin for "line prophylaxis").

Primary outcomes:
measure: Number of units of allogeneic blood products required early perioperatively in pediatric cardiac patients.
timeFrame: approximately 1 day postoperatively
Secondary outcomes:
measure: Hospital length of stay
timeFrame: Through hospital discharge, approximately 3 days
measure: Mortality
timeFrame: Through hospital discharge, approximately 3 days
measure: Intravascular and intracardiac thromboses
timeFrame: approximately 3 days postoperatively
Other outcomes:
Locations:
Study officials:
affiliation: Mayo Clinic
name: Elena Ashikhmina, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00227383: Effect of Electroacupuncture in Diabetic Patients With Gastroparesis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Diabetes Mellitus
Gastroparesis
Keywords: Diabetes
gastroparesis
electroacupuncture
Lead sponsor: China Medical University Hospital
Sponsor class: OTHER
First posted: 2005-09-28
Enrollment: 30
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: In this study, we aim at evaluating the effect of electroacupuncture in diabetic patients with gastroparesis. Patient-based symptom severity measure, serum parameters and solid-phase gastric emptying time are measured to evaluate the effectiveness of electroacupuncture.

Detailed description: Initially, we will collect 30 patients with type 2 diabetes with a ≧ 3-month history of dyspeptic symptoms. An upper GI endocopy will be obtained to rule out possibility of organic obstruction. Cardiac arrhythmia and pregnancy will be excluded. None of them ever received abdominal surgery. Patients are then randomized to one of two treatment arms. Arm I: 15 patients received EA stimulation on acupoints St-36 (Zusanli) and Li-4 (Hegu). Arm II: 15 subjected to EA stimulation on non-acupoints around St-36 and Li-4 with the same electrical pulse and amplitude. Gastroparesis Cardinal Symptom Index (GCSI) and solid-phase gastric emptying time will be measured on baseline and after EA. In addition, serum gastrin, motilin, human pancreatic polypeptide, fasting blood sugar, and postprandial glucose levels will be also monitored.

Eligibility criteria: Inclusion Criteria:

* Type 2 diabetes
* Dyspetic symptoms for more than 3 months
* Symptoms include nausea, vomiting, upper abdominal discomfort, early satiety, bloating and anorexia

Exclusion Criteria:

* Organic gastrointestinal obstruction
* Previous surgery of gastrointestinal tract
* Cardiac arrhythmia
* Pregnancy

Primary outcomes:
measure: Solid-phase gastric emptying time and score on Gastroparesis Cardinal Symptom Index(GCSI) at 2 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Taichung
country: Taiwan
facility: China Medical University Hospital
Study officials:
affiliation: China Medical University Hospital
name: Chung-Pang Wang, MD
role: STUDY_CHAIR
References:
Clinical trial NCT03720483: Inhaled NAC in Treatment of IPF
Official title: Pilot Study to Evaluate Inhaled N-Acetylcysteine in Pulmonary Fibrosis
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
PHASE2
Conditions: Idiopathic Pulmonary Fibrosis (IPF)
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
First posted: 2018-10-25
Enrollment: 0
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This study plans to learn more about the safety and tolerability of inhaled N-Acetylcysteine (NAC) in patients with pulmonary fibrosis. The study will also create a bank of data, blood, and sputum from IPF patients for future research.

Detailed description: This study plans to learn more about the safety and tolerability of inhaled N-Acetylcysteine (NAC) in patients with pulmonary fibrosis. The study will also create a bank of data, blood, and sputum from IPF patients for future research.

NAC is a medication used to loosen thick mucus. NAC was initially licensed for use in 1968. It is on the World Health Organization's List of Essential Medicines, the most effective and safe medicines needed in a health system, and it is available as a generic medication and is not very expensive. Inhaled NAC has been used as a mucus-dissolving therapy in respiratory conditions with excessive and/or thick mucus production.

Eligibility criteria: Inclusion Criteria:

* Diagnosed by study team with expertise in IPF utilizing standard ATS/ERS definition of "probable" or "definite" IPF
* DLCO \>50% predicted
* FVC \>60% predicted
* FEV1/FVC \> 0.7

Exclusion Criteria:

* History of bronchospasm (requiring treatment)
* Current acute exacerbation of their IPF disease
* Current smoker
* Supplemental O2 requirement \> 4 liters/min via nasal cannula
* History of asthma, COPD, coronary artery disease, or cancer
* Currently using NAC, hypertonic saline, or DNase (dornase alfa) inhalation therapy

Primary outcomes:
measure: Changes in Pulmonary function - FVC
timeFrame: Baseline, week 10, and week 18
measure: Changes in Pulmonary function - DLCO
timeFrame: Baseline, week 10, and week 18
Secondary outcomes:
Other outcomes:
Locations:
city: Aurora
country: United States
facility: University of Colorado Anschutz Medical Campus
state: Colorado
Study officials:
affiliation: University of Colorado, Denver
name: Mark Steele, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02243683: Safety Study of Immune System Modulator for Autoimmune Diseases
Official title: A Randomized, Placebo Controlled, Double Blind, Dose Escalating, Crossover, Safety and Pharmacokinetic Study of AX-024.HCl in Healthy Male Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Lead sponsor: Artax Biopharma Inc
Sponsor class: INDUSTRY
Collaborators: name: Simbec Research
name: ORION Clinical Services
name: Packaging Coordinators Inc
name: Centro de Biología Molecular Severo Ochoa, Spain (CBMSO)
First posted: 2014-09-18
Enrollment: 18
Sex: MALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief summary: The purpose of this study is to determine the toxicity, tolerability and safety of single ascending doses of AX-024.HCl in healthy male subjects.


Eligibility criteria: Inclusion Criteria:

* Subjects with a body mass index (BMI) of 18 - 35 kg/m2, inclusive. BMI = Body weight (kg) / \[Height (m)\]2.
* In good health as determined by medical history, physical examination, and clinical judgment of the investigator
* Subject with no history of autoimmune disease or cardiac disease
* Subjects must be available to complete the study (including follow-up visit).
* Subjects must satisfy a medical examiner about their fitness to participate in the study.
* Subjects must provide written informed consent to participate in the study.

Exclusion Criteria:

* A clinically significant history of gastrointestinal disorder likely to influence drug absorption.
* Receipt of regular medication within 21 days of the first dose that may have an impact on the safety and objectives of the study (at the Investigator's discretion).
* Evidence of renal, hepatic, central nervous system, respiratory, cardiovascular or metabolic dysfunction.
* Subjects who are smokers, or ex-smokers who have smoked in the last 3 months (determined by negative urine cotinine at screening visit).
* A clinically significant history of hypersensitivity (anaphylaxis, angioedema) to any drug.
* A clinically significant history of drug or alcohol abuse.
* Participation in a New Chemical Entity clinical study within the previous 4 months or a marketed drug clinical study within the previous 3 months. (N.B. washout period between studies is defined as the period of time elapsed between the last dose of the previous study and the first dose of the next study).

Primary outcomes:
measure: Number of Participants with Serious and Non-Serious Adverse Events
timeFrame: Over a 72 hours period and 7 days after last dose
Secondary outcomes:
measure: Area Under the Concentration-Time Curve
timeFrame: Over a 72 hours period post dose
Other outcomes:
Locations:
city: Merthyr Tydfil
country: United Kingdom
facility: Simbec Research Ltd
state: Cardiff Road
Study officials:
affiliation: Simbec Research
name: Girish Sharma, MBBS
role: PRINCIPAL_INVESTIGATOR
References: