louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00543998: Near Infrared Transillumination of the Paranasal Sinuses
Official title: Near Infrared Transillumination of the Paranasal Sinuses
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sinusitis
Keywords: Sinusitis
Lead sponsor: University of California, Irvine
Sponsor class: OTHER
Collaborators: name: Beckman Laser Institute University of California Irvine
First posted: 2007-10-16
Enrollment: 33
Sex: ALL
Minimum age (years): 15
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: primary care clinic,

Brief summary: This research project designed to diagnose sinusitis using a simple and low-cost optical tool. Healthy sinuses are typically filled with air, and show up as bright spots on the camera. Infected sinuses are filled with fluid and show up dark spots on the camera. Images of infected sinuses could be used to diagnose sinusitis, or to check if surgical treatments on the sinuses have been successful.

Detailed description: This device consists of a specialized flashlight that uses mostly non-visible light, and a small camera to record the light. The tool is the size and shape of spoon. The technique of shining light into the mouth, face, and sinuses is known as "transillumination" and has been used for nearly a century to aid in the diagnosis of sinusitis. The tool described in this study is a custom made device that uses light that is invisible to the eye.

Eligibility criteria: Inclusion Criteria:

* male and female age of 15 years or older.
* Has diagnose of sinusitis, nasal allergies,nasal breathing problem, and tumors.

Exclusion Criteria:

* Age less than 15 year sold

Primary outcomes:
measure: Healthy Sinus
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Irvine
country: United States
facility: Beckman Laser Institute Medical Cinic, University of California,Irvine
state: California
city: Irvine
country: United States
facility: Otolaryngology Medical Clinic, University of California, Irvine
state: California
Study officials:
affiliation: Beckman Laser Institute University of California Irvine
name: Brian JF Wong, M.D.,Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00055198: Daptomycin for the Treatment of Infections Due to Gram-Positive Bacteria
Official title: A Compassionate Use Protocol for Intravenous Daptomycin for the Treatment of Infections Due to Gram-Positive Bacteria That Cannot be Adequately Treated With Currently Available Therapy
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Gram-Positive Bacterial Infections
Keywords: Gram positive bacterial infections
expanded access program
resistant infections
bacteremia
Bacterial and fungal infections
bacterial infections
Lead sponsor: Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
Sponsor class: INDUSTRY
First posted: 2003-02-21
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to provide daptomycin, an antibiotic, to patients who are failing conventional therapy, or who cannot take approved antibiotics for one reason or another.


Eligibility criteria: Main Inclusion Criteria:

* Infection caused by Staphylococcus aureus, Staphylococcus epidermidis, Enterococcus faecalis, or Enterococcus faecium that requires inpatient hospitalization and treatment with injectable antibiotics\*\*
* Site of infection: complicated skin and skin structure infection; urinary tract infection; intra-abdominal infection; infective endocarditis; or bloodstream infection (including catheter-related).
* Pathogen resistant to, or patient intolerant of: beta-lactams, vancomycin, quinupristin/dalfopristin, or linezolid.
* Unable to receive any other standard commercially available antibacterial therapy for the infection.

Main Exclusion Criteria:

* Creatinine clearance less than 40 mL/min\*\*
* Hemodialysis or peritoneal dialysis
* Admitted to the hospital for drug overdose or other conditions associated with rhabdomyolysis, or is expected to require repeated intramuscular injections
* Creatine phosphokinase (CPK) level greater than 2.5 times above the upper limit of normal (ULN) at screening; if the elevation in CPK can be attributed to an obvious cause (eg, surgery)\*\*
* Central nervous system infection
* Pulmonary infection.

(\*\*) An exemption may be granted for patients not satisfying these criteria following a conversation with the Medical Monitor.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01301898: To Evaluate the Safety and Efficacy of GC1111 (Recombinant Human Iduronate-2-sulfatase) in Hunter Syndrome Patients
Official title: Randomized, Single-blind, Active-controlled, Phase 1/2 Study to Evaluate the Safety and Efficacy of GC1111 (Recombinant Human Iduronate-2-sulfatase) in Hunter Syndrome (Mucopolysaccharidosis II) Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Mucopolysaccharidosis II
Keywords: Hunter syndrome
MPS II
Idursulfase
Lead sponsor: GC Biopharma Corp
Sponsor class: INDUSTRY
First posted: 2011-02-23
Enrollment: 31
Sex: MALE
Minimum age (years): 6
Maximum age (years): 35
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the safety and efficacy of GC1111 (recombinant human iduronate-w-sulfatase) in Hunter Syndrome (Mucopolysaccharidosis II) patients


Eligibility criteria: Inclusion Criteria:

1. Patients with diagnosis of MPS II based on both clinical and biochemical criteria
2. Male, ages 6 to 35 years old
3. Patients who are able to comply with the study requirements
4. Patients who have given voluntary written consent to participate in the study
5. Patients who is acceptable for using an appropriate method of contraception

Exclusion Criteria:

1. History of a tracheostomy or a bone marrow transplant
2. Known hypersensitivity to idursulfase
3. Known shock to idursulfase
4. History of receiving treatment with another investigational therapy within the past 30 days
5. History of a stem cell transplant
6. Known hypersensitivity to any of the components of idursulfase
7. Female

Primary outcomes:
measure: Primary Outcome
timeFrame: baseline, every 4 weeks
Secondary outcomes:
measure: Secondary Outcome
timeFrame: baseline, every 12 weeks
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
state: Irwon-dong, Gangnam-Gu
Study officials:
References:
citation: Sohn YB, Cho SY, Park SW, Kim SJ, Ko AR, Kwon EK, Han SJ, Jin DK. Phase I/II clinical trial of enzyme replacement therapy with idursulfase beta in patients with mucopolysaccharidosis II (Hunter syndrome). Orphanet J Rare Dis. 2013 Mar 18;8:42. doi: 10.1186/1750-1172-8-42.
Clinical trial NCT06894498: Five PLus Year EffIcacy of Endoscopic Sleeve Gastroplasty (ESG) for Sustained WeigHT Loss
Official title: Five PLus Year EffIcacy of Endoscopic Sleeve Gastroplasty (ESG) for Sustained WeigHT Loss
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Obesity and Obesity-related Medical Conditions
Weight Loss
Lead sponsor: Boston Scientific Corporation
Sponsor class: INDUSTRY
First posted: 2025-03-25
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Study participants will be selected from weight loss or bariatric centers

Brief summary: The objective of this study is to assess the long term weight loss and weight loss journey of patients who received an Endoscopic Sleeve Gastroplasty (ESG) 5 or more years prior to enrollment.

Detailed description: Includes retrospective data collection and one prospective visit

Eligibility criteria: Inclusion Criteria:

* Subject is ≥ 18 years of age at the time of the ESG procedure
* Subject with a BMI between 30 kg/m2 and 50 kg/m2, inclusive, at the time of the primary ESG procedure using Overstitch Endoscopic Suturing System
* Subject completed follow-up 1-year from the ESG procedure for weight loss management
* Subject completed or is eligible for follow-up 5-years from the ESG procedure for weight loss management (visit can be collected either retrospectively or prospectively)
* Subject has returned for a minimum of one annual follow-up at the treating site for weight loss management annually between two and four years from the procedure.
* Subject is willing to complete one prospective visit (5 year or 5+ year, as appropriate)
* Subject is able to read, understand, and sign a written Informed Consent Form to participate in the study

Exclusion Criteria:

* None

Primary outcomes:
measure: Proportion of subjects that maintain clinically significant weightloss at five-year visit
timeFrame: TBWL assessed at five-years post ESG
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00001998: Pharmacokinetics of Nystatin LF I.V. in Patients With Acquired Immune Deficiency Syndrome-Related Complex (ARC)
Official title: Pharmacokinetics of Nystatin LF I.V. in Patients With Acquired Immune Deficiency Syndrome-Related Complex (ARC)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV Infections
Keywords: Nystatin
Acquired Immunodeficiency Syndrome
AIDS-Related Complex
Lead sponsor: NIH AIDS Clinical Trials Information Service
Sponsor class: INDUSTRY
First posted: 2001-08-31
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: To define the pharmacokinetic characteristics of Nystatin LF IV (intravenous) in human subjects with AIDS-related complex (ARC) after administration of a single IV dose at each of 4 dose levels.


Eligibility criteria: Inclusion Criteria

Patients must have the following:

* Positive HIV antibody test.
* Diagnosis of AIDS-related complex (ARC).
* CD4+ cell count between 100 and 300 cells/mm3.
* Estimated life expectancy of at least 6 months.
* Normal neurological status.

Exclusion Criteria

Co-existing Condition:

Patients with the following conditions or symptoms are excluded:

* Active opportunistic infection requiring ongoing therapy except patients being treated topically for oral thrush.

Patients with the following are excluded:

* Active opportunistic infection.
* Known hypersensitivity to polyene antibiotics.
* Unwillingness to sign an informed consent or to be in compliance of protocol requirements.

Prior Medication:

Excluded within 72 hours of study entry:

* Biologic response modifier agents.
* Corticosteroids.
* Cytotoxic chemotherapeutic agents.
* Potential nephrotoxins.
* Potential neutropenic agents.
* Rifampin or rifampin derivatives.
* Systemic anti-infectives.
* Phenytoin or barbiturates (inducers of microsomal enzymes).
* All systemic medications.

Prior Treatment:

Excluded within 72 hours prior to study entry:

* Radiation therapy.

Active alcohol or drug abuse unless they have been off drugs and/or alcohol for two weeks prior to start of study.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: Twelve Oaks Hosp
state: Texas
Study officials:
References:
citation: Rios A, Crofoot GE, Lenk R, Hayman A, Rosenblum M, Lopez-Berestein G. A phase 1 single dose safety evaluation and pharmacokinetic (Pkc) study of nystatin-liposomal formulation nystatin-LF i.v. in patients with HIV infection. Int Conf AIDS. 1992 Jul 19-24;8(3):127 (abstract no PuB 7473)
Clinical trial NCT02999698: Patients With Hidradenitis vs Patients With Psoriasis: Psychological Impact
Official title: A Comparative Retrospective Study Between Patients With Hidradenitis vs Patients With Psoriasis: Psychological Impact
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Psoriasis
Hidradenitis
Keywords: Psoriasis
Hidradenitis
Psychological impact
Quality of life
Lead sponsor: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Sponsor class: OTHER
Collaborators: name: Universitat Autonoma de Barcelona
First posted: 2016-12-21
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients diagnosed with hidradenitis suppurativa or psoriasis who have completed the questionnaires for psychological impact in the Hospital de la Santa Creu and Sant Pau, Barcelona.

Brief summary: The aim of this study is to evaluate the psychological impact of psoriasis or hidradenitis suppurativa on patients, in order to compare both pathologies.


Eligibility criteria: Inclusion Criteria:

* Men and women at least 18 years old at the time of selection.
* Subjects diagnosed with psoriasis or hidradenitis suppurativa
* Subjects who had completed the questionnaires for psychological impact.
* Patients should be able to understand and communicate with the investigator.

Exclusion Criteria:

* Subjects suffering from a serious concomitant illness.
* Subjects with a mental illness.
* Subjects who are performing psychiatric treatment.
* Patients who have alcohol dependence or drug abuse.
* Subjects that present legal incapacity or limited legal capacity.
* Subjects presenting illiteracy or language barriers.

Primary outcomes:
measure: Dermatology Quality of Life Index (DLQI)
timeFrame: 1 day
measure: Hospital Anxiety and Depression Scale (HADS)
timeFrame: 1 day
measure: Perceived Stress Scale (PSS)
timeFrame: 1 day
measure: The Holmes and Rahe stress scale
timeFrame: 1 day
Secondary outcomes:
measure: Psoriasis Area Severity Index (PASI)
timeFrame: 1 day
measure: Static Physician's Global Assessment (sPGA)
timeFrame: 1 day
measure: Hurley's staging system
timeFrame: 1 day
measure: Hidradenitis Suppurativa - Physician Global Assessment (HS-PGA)
timeFrame: 1 day
Other outcomes:
Locations:
Study officials:
affiliation: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
name: Esther Margarit de Miguel, Msc
role: PRINCIPAL_INVESTIGATOR
affiliation: Universitat Autonoma de Barcelona
name: Antoni Font Guiteras, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT05682898: Perioperative Management of Colorectal Cancer Patients Infected With COVID-19: a Multicenter Prospective Cohort Study.
Official title: Perioperative Management of Colorectal Cancer Patients Infected With COVID-19: a Multicenter Prospective Cohort Study.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Colorectal Cancer
Surgical Procedure, Unspecified
Lead sponsor: Changhai Hospital
Sponsor class: OTHER
First posted: 2023-01-12
Enrollment: 300
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Colorectal cancer patients undergoing surgery with perioperative COVID-19 infection.

Brief summary: This trial is a multicenter prospective cohort study to explore timing of colorectal cancer surgery after COVID-19 infection so that can assist clinicians and patients. Currently, there is less evidence on perioperative outcomes after COVID-19 vaccination and the omicron variant. Therefore, it is necessary to update previously published consensus which recommends that patients should avoid elective surgery within 7 weeks of COVID-19 infection remain, unless the benefits of doing so exceed the risk of waiting. Aiming at the above problems, we plan to carry out a multicenter prospective cohort study to develop perioperative management according patients' different conditions.


Eligibility criteria: Inclusion Criteria:

* undergoing colorectal cancer surgery
* infected with COVID-19 but nucleic acid test result is negative
* the patients compliance is good
* signed the consents voluntarily

Exclusion Criteria:

* undergoing emergency surgery(intestinal obstruction, intestinal perforation, intestinal hemorrhage, et al.)
* The patients' situations which judged by situations is not suitable to participate in the clinical trial

Primary outcomes:
measure: Incidence of surgical complications
timeFrame: 30 days after surgery
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05560698: A Motivation-enhancing App to Retain Patients With Hay Fever in a Trial After Treatment
Official title: A Motivation-enhancing Intervention to Retain Participants in a Trial After Treatment With Allergen Immunotherapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Grass Pollen Allergy
Rhinoconjunctivitis
Keywords: Retention
Motivation
Self-Determination Theory
Grass Pollen Allergic Rhinoconjunctivitis
Intralymphatic Immunotherapy
Patient and Public Involvement
Lead sponsor: University of Aarhus
Sponsor class: OTHER
Collaborators: name: Aarhus University Hospital
name: Innovation Fund Denmark
First posted: 2022-09-29
Enrollment: 224
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants are randomized 1:1 across treatment group
Primary purpose: OTHER

Brief summary: The motivation-enhancing intervention is designed for participants in the ILIT.NU trial. The participants are patients with hay fever who are treated with a vaccination in an inguinal lymph node. The motivation-enhancing intervention is a web-based app developed in collaboration with patient partners and is intended to increase retention and reporting in the ILIT.NU trial.

Detailed description: The ILIT.NU trial (EudraCT 2020-001060-28) investigates whether patient reported outcome measures compound symptom-medication score (cSMS) are relieved by intralymphatic immunotherapy (ILIT). The participants are asked for a three-year period to attend annual consultations and to daily fill in an online questionnaire about their allergy symptoms and medication use during the grass pollen season (100 days).

High attrition rates have been a problem in previous ILIT trials. High attrition affects generalizability, validity and reliability of a trial. To increase retention and reporting in the ILIT.NU trial, a motivation-enhancing web-based app has been developed. The web app is based on the Self-Determination Theory and is developed in collaboration with patient partners and clinicians. Participants are randomized across treatment group to either the motivation-enhancing web app or the standard reporting method. The project is conducted as a Study Within a Trial (SWAT).

Eligibility criteria: Inclusion Criteria:

* Participants enrolled in the ILIT.NU trial

Exclusion Criteria:

* Participants not enrolled in the ILIT.NU trial, Denmark

Primary outcomes:
measure: Rate of reporting daily cSMS data
timeFrame: 16 weeks
Secondary outcomes:
measure: Retention
timeFrame: 16 weeks
measure: Motivation
timeFrame: 14 days
measure: Participant experience with the web-based app
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Anne Poder Petersen
Study officials:
affiliation: University of Aarhus
name: Anne Poder Petersen
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06280898: Perioperative Factors and Early Postoperative Kidney Graft Function Recovery
Official title: Analysis of Perioperative Factors Affecting Early Postoperative Kidney Graft Function Recovery in Patients Undergoing Living Kidney Transplant Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Heart Injuries
Kidney Transplant; Complications
Lead sponsor: Seoul St. Mary's Hospital
Sponsor class: OTHER
First posted: 2024-02-28
Enrollment: 539
Sex: ALL
Minimum age (years): 19
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adult patients aged 19 or older who underwent kidney transplant surgery in the operating room of Seoul St. Mary's Hospital from January 1, 2016 to March 28, 2022.

Brief summary: Divided into two groups based on acute kidney injury: non-acute kidney injury group vs. non-acute kidney injury group. Acute kidney injury group, Acute Kidney Injury Network (AKIN), Risk, Injury, Failure, Loss of kidney function, and End-stage kidney disease (RIFLE), or Kidney Disease: Improving Global Outcomes (KDIGO) I would like to divide it according to the definition. After testing the normal distribution of patients, donors, grafts, types of immunosuppressants, surgery/anesthesia factors, and blood test findings between the two groups through the Shapiro-Wilk test, continuous data was tested using the student t-test or Mann-Whitney U test. Sizes are compared using , and categorical data is compared with proportions using the χ2 test or Fisher's exact test. Analysis of factors related to acute kidney injury will be performed through univariate and multivariate logistic regression analysis.


Eligibility criteria: Inclusion Criteria:

* Adult patients aged 19 years or older who underwent kidney transplant surgery in the operating room

Exclusion Criteria:

* Pediatric patients under 19 years of age
* Patients with multiple organ transplants, including kidney transplants
* Patients undergoing re-kidney transplant surgery
* Patient examination findings missing from electronic medical record

Primary outcomes:
measure: Troponin I
timeFrame: up to 24 hour postoperatively
Secondary outcomes:
measure: Troponin T
timeFrame: up to 24 hour postoperatively
measure: QTc interval
timeFrame: up to 24 hour postoperatively
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul St. Mary's hospital
Study officials:
References: