louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05474430: Estimating Risk of Respiratory Infections Attributable to CFTR Heterozygosity
Official title: Estimating the Risk for and Severity of Respiratory Infections Attributable to CFTR Heterozygosity
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Carrier State
Respiratory Infections
Lead sponsor: University of Iowa
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: National Institute of Allergy and Infectious Diseases (NIAID)
First posted: 2022-07-26
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: CF Carriers and Controls who are not CF carriers.

Brief summary: A research team member will brush the inferior surface of the subjects' middle turbinate (nasal cavity) using a cytology brush to obtain the cells needed to perform our functional respiratory assays.

An individual trained in phlebotomy will draw one 3 ml lavender top tube of blood to test c-reactive protein, calprotectin, and lactoferrin. They will also draw a 5 ml gold top serum separator tube of blood to test fibroblast growth factor-19.

The participant will answer questions from the baseline survey and report their current medications interview-style with the research team member.


Eligibility criteria: CF Carrier Inclusion Criteria:

* Previously tested and shown to be a CF carrier
* English-speaking

Control Group Inclusion Criteria:

* Previously tested and shown to not be a CF carrier or CF patient
* English-speaking

Exclusion Criteria:

* Currently sick with a respiratory infection
* Prisoner Status
* Unable to provide own written, informed consent

Primary outcomes:
measure: Comparison of Chloride Transport Values
timeFrame: At baseline
measure: Comparison of Bicarbonate Transport Values
timeFrame: At baseline
measure: Comparison of Airway Surface Liquid pH Values
timeFrame: At baseline
measure: Comparison of Mucous Viscosity Values
timeFrame: At baseline
measure: Comparison of Bacterial Killing Values
timeFrame: At baseline
Secondary outcomes:
measure: Comparison of Fibroblast Growth Factor-19 Values
timeFrame: At baseline
Other outcomes:
Locations:
city: Iowa City
country: United States
facility: University of Iowa Hospitals and Clinics
state: Iowa
Study officials:
affiliation: University of Iowa
name: Philip M Polgreen, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05027230: A Safety and Efficacy Study of STSP-0601 in Adult Patients With Hemophilia A or B With Inhibitor
Official title: A Phase Ib/II,Multi-center, Open, Multiple-dose Design to Evaluate the Safety,Tolerability and Efficacy of STSP-0601 for Injection in Patients With Inhibitory Hemophilia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Hemophilia
Lead sponsor: Staidson (Beijing) Biopharmaceuticals Co., Ltd
Sponsor class: INDUSTRY
First posted: 2021-08-30
Enrollment: 77
Sex: MALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: This study will assess the safety and efficacy of multiple-dose of STSP-0601 for the treatment of bleeding episodes in hemophilia A or B patients with inhibitors.


Eligibility criteria: Inclusion Criteria:

* 18 years old ≤age≤65 years of age,male.
* Hemophilia A or B patients with inhibitors.
* Received hemostatic treatment with investigational drug, or to undergo minor surgical or other invasive procedures (Only for phase 2. Minor surgical procedures: procedures without general anesthesia and the wounds are easy to observe).
* Peak historical inhibitor titer ≥ 5 BU and a positive inhibitor test when enrolled.
* Establish proper venous access.
* Agree to use adequate contraception to avoid pregnancy.
* Provide signed informed consent.

Exclusion Criteria:

* Have any coagulation disorder other than hemophilia A or B.
* Treat with prophylactic treatment of coagulation factor.
* Treat with anticoagulant within 7d of the time of study drug administration.
* Have a history of arterial and/or venous thromboembolic events.
* Have platelet \<100,000/mL,hemoglobin\<90g/L.
* Severe liver or kidney disease.
* Bleeding in the central nervous system or throat before screening.
* Accept major operation or blood transfusion within 1 month of the time of screening.
* HIV positive with current CD4+ count of less than 200/μl.
* Have a known allergy to Blood product.
* Participate in other clinical research within 1 month of the time of study drug administration.
* Treat with coagulant within 7d of the time of study drug administration.

Primary outcomes:
measure: Incidence of adverse events
timeFrame: From day 0 to up to day 8
measure: Proportion of successfully treated bleeding episodes
timeFrame: 24 hours after administration of study drug
Secondary outcomes:
measure: Proportion of bleeding episodes with clinical relief of signs and symptoms
timeFrame: 4 hours、8 hours、24 hours after first administration of study drug
Other outcomes:
Locations:
city: Tianjin
country: China
facility: Hospital of Hematology, Chinese Academy of Medical Sciences
state: Tianjin
Study officials:
affiliation: Hospital of Hematology, Chinese Academy of Medical Sciences
name: Lei Zhang, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02537730: BIOCLEAN MPS (Multi-Purpose Solution) VII in Combination With Biofinity Lens: A Two Week Crossover Study
Official title: BIOCLEAN MPS (Multi-Purpose Solution) VII in Combination With Biofinity Lens: A Two Week Crossover Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Myopia
Lead sponsor: CooperVision International Limited (CVIL)
Sponsor class: INDUSTRY
First posted: 2015-09-02
Enrollment: 33
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Two week, Open Label, randomized, bilateral, crossover, 1 week of daily wear in each combination (lens / disinfecting cleaning system).

Detailed description: To determine if patients are unreactive to the lens care solution / Biofinity combination. It is expected that there will be a total of three visits: V1 (Initial), V2 (1 week), \& V3 (2 weeks).

Eligibility criteria: Inclusion Criteria:

* Is over 18 years of age (inclusive)
* Has had a self-reported visual exam in the last two years
* Has a CL (contact lens) spherical prescription between -0.25D (Diopters) and -12.00D (inclusive)
* Has less than 1.00 D spectacle cylinder in each eye
* Is correctable to a visual acuity of 20/20 or better in both eyes
* Has clear corneas and no active ocular disease
* Has read, understood and signed the informed consent letter
* Is willing to comply with the wear schedule (at least 40hrs per week)
* Is willing to comply with the visit schedule

Exclusion Criteria:

* Has never worn contact lenses before
* Currently wears rigid gas permeable contact lens
* Has a history of not achieving comfortable CL (contact lens) wear (5 days per week; \> 8 hours per day)
* Has a CL prescription outside the range of -0.25D to -12.00D
* Has a spectacle cylinder greater than -0.75D of cylinder in either eye
* Has best corrected spectacle distant vision worse than 20/20 in ether eye
* Has any systemic disease affecting ocular health
* Is using any systemic or topical medications that will affect ocular health
* Has any ocular pathology or sever insufficiency of lacrimal secretion
* Has persistent, clinically significant corneal or conjunctival staining
* Has active neovascularization or any central corneal scars
* Is aphakic
* Is pregnant or lactating

Primary outcomes:
measure: Ocular Health - Corneal Staining
timeFrame: 1 week
Secondary outcomes:
measure: Comfort
timeFrame: 1 week
measure: Dryness
timeFrame: 1 week
measure: Stinging and Burning Sensation
timeFrame: Baseline
Other outcomes:
Locations:
city: Joyo-shi
country: Japan
facility: Kodama Eye Clinic
state: Kyoto-fu
city: Kameoka
country: Japan
facility: Higashihara Eye Clinic
state: Kyoto-fu
city: Osaka-shi
country: Japan
facility: Iwasaki Eye Clinic
state: Osaka-fu
Study officials:
affiliation: Kodama Eye Clinic
name: Yuji Kodama, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00152230: A Randomized Controlled Study of Postoperative Adjuvant Chemotherapy of Uracil- Tegafur (UFT) Compared With Surgery Alone (NSAS-CC)
Official title: A Randomized Controlled Study of Postoperative Adjuvant Chemotherapy of UFT Compared With Surgery Alone in Patients With Dukes C Colorectal Cancer (NSAS-CC)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Colorectal Cancer
Keywords: Colorectal Cancer
Lead sponsor: Taiho Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2005-09-09
Enrollment: 900
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a controlled study designed to compare relapse-free survival and overall survival in patients receiving UFT with those in patients receiving surgery alone. Patients will be randomly assigned to surgery alone or surgery followed by UFT within 6 weeks after curative resection. To assess treatment efficacy, data on recurrence and survival will be collected for 5 years after enrollment of the last patient. To evaluate safety, data on adverse events will be collected for 12 months after the start of treatment.Evaluations will be separately done for colon cancer and rectal cancer.


Eligibility criteria: Inclusion Criteria:

* Age 20 to 75
* Performance status 0 , 1, or 2 (ECOG)
* Hematopoietic WBC ≥ 4,000/mm\^3 Platelet ≥ 100,000/mm\^3
* Hepatic AST and ALT ≤ 2 times upper limit of normal(ULN) Total bilirubin ≤ 1.2mg/dL
* Renal BUN ≤ 25mg/dL Creatinine ≤ 1.5mg/dL

Exclusion Criteria:

* Prior anticancer treatment

Primary outcomes:
measure: Relapse-free survival and overall survival
timeFrame: every course for first three courses, then every other course
Secondary outcomes:
measure: Adverse events
timeFrame: any time
Other outcomes:
Locations:
city: 6-5-1, Kashiwanoha, Kashiwa, Chiba
country: Japan
facility: National Cancer Center Hospital East
Study officials:
affiliation: National Cancer Center Hospital East
name: Shigeaki Yoshida, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hamaguchi T, Shirao K, Moriya Y, Yoshida S, Kodaira S, Ohashi Y; NSAS-CC Group. Final results of randomized trials by the National Surgical Adjuvant Study of Colorectal Cancer (NSAS-CC). Cancer Chemother Pharmacol. 2011 Mar;67(3):587-96. doi: 10.1007/s00280-010-1358-1. Epub 2010 May 19.
citation: Akasu T, Moriya Y, Ohashi Y, Yoshida S, Shirao K, Kodaira S; National Surgical Adjuvant Study of Colorectal Cancer. Adjuvant chemotherapy with uracil-tegafur for pathological stage III rectal cancer after mesorectal excision with selective lateral pelvic lymphadenectomy: a multicenter randomized controlled trial. Jpn J Clin Oncol. 2006 Apr;36(4):237-44. doi: 10.1093/jjco/hyl014. Epub 2006 May 4.
Clinical trial NCT00968630: Immune Response After Stem Cell Transplant in HIV-Positive Patients With Hematologic Cancer
Official title: Human Immunodeficiency Virus (HIV)-Specific Immune Reconstitution After Hematopoietic Cell Transplant for Treatment of Hematologic Malignancy in Patients Infected With HIV
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Hematopoietic and Lymphoid Cell Neoplasm
HIV Infection
Lead sponsor: Fred Hutchinson Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
name: National Institute of Allergy and Infectious Diseases (NIAID)
First posted: 2009-08-31
Enrollment: 9
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This phase II trial studies the immune response after stem cell transplant in human immunodeficiency virus (HIV)-positive patients with hematologic cancer (blood cancer). Studying samples of blood from HIV-positive patients with cancer in the laboratory may help doctors learn more about changes that occur in the immune system after stem cell transplant.

Detailed description: PRIMARY OBJECTIVES:

I. Examine the development of donor-derived HIV-1-specific immune response following hematopoietic cell transplant (HCT) for treatment of hematologic malignancy in HIV+ patients.

II. Examine the affect of HCT on the pool of latently infected cluster of differentiation (CD)4+ T cells in HIV+ patients given HCT for treatment of hematologic malignancy.

OUTLINE:

Patients undergo leukapheresis for analysis of HIV-1 latent reservoir at baseline and at days +90, +180, +365, and +730, and then annually thereafter as feasible.

Eligibility criteria: Inclusion Criteria:

* HIV positive
* Treatment with highly active antiretroviral therapy (HAART) for at least 1 month
* Viral load has decreased by \>= 1.5 logs or viral load \< 5000 copies/ml plasma on HAART therapy
* Hematologic malignancy associated with a poor prognosis or other diagnosis for which hematopoietic cell therapy (allogeneic or autologous, including gene therapy) is indicated
* Approval for allogenic regimen given at Patient Care Conference
* DONOR: Autologous or allogeneic gene modified cells allowed

Exclusion Criteria:

* A medical history of noncompliance with HAART or medical therapy
* Inability to provide informed consent
* DONOR: Allogeneic donors must not have HIV infection

Primary outcomes:
measure: Quantification of donor-derived HIV-1-specific immune responses following HCT
timeFrame: Up to 1 year
measure: Quantification of latently infected CD4+ cells in HIV+ patients
timeFrame: Up to 7 years
Secondary outcomes:
Other outcomes:
Locations:
city: Seattle
country: United States
facility: Fred Hutch/University of Washington Cancer Consortium
state: Washington
Study officials:
affiliation: Fred Hutch/University of Washington Cancer Consortium
name: Ann Woolfrey
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05909930: Effectiveness of TheRApeutic ExercIse aNd EDucation on Patients With Massive Rotator Cuff Tears
Official title: Effectiveness of TheRApeutic ExercIse aNd EDucation on Patients With Massive Rotator Cuff Tears (the TRAINED Study): a Multicenter Non-controlled Trial
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: NA
Conditions: Rotator Cuff Injuries
Keywords: Physical therapy
Massive rotator cuff tear
Therapeutic resistance exercise
Multicenter
Lead sponsor: Hospital Universitario Fundación Alcorcón
Sponsor class: OTHER
Collaborators: name: Hospital Universitario La Paz
name: Hospital Universitario Ramon y Cajal
name: Hospital Universitario La Princesa
name: Hospital General Universitario Gregorio Marañon
name: Hospital Universitario Principe de Asturias
name: Hospital Universitario de Fuenlabrada
name: Hospital Universitario Infanta Leonor - Vallecas/H. Virgen de la Torre
First posted: 2023-06-18
Enrollment: 149
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The aim of this multicenter non-controlled study will be to evaluate the effectiveness of a physical therapy treatment based on resistance exercise and education for patients with massive rotator cuff tears.


Eligibility criteria: Inclusion Criteria:

* Massive rotator cuff tear diagnosed by ultrasound imaging or magnetic resonance imaging. The definition of massive will be the rears including 2 or more tneonds, or the ones with an extension equal or greater to 5cm in the short or long axis.
* To have a degree of disability equal or greater to 15% in the Oxford Shoulder Score.
* Adequate comprehension of written and spoken Spanish

Exclusion Criteria:

* Loss of passive external rotation at 0º of shoulder abduction equal or greater to 50% compared to contralateral side.
* Suspected neck-related shoulder pain.
* Suspected visceral-related shoulder pain.
* Humerus and/or scapular fractures within the last year.
* Previous rotator cuff repair surgery within the last year.
* Presence of cancer, fibromyalgia, neurological and/or other systemic diseases.
* Cognitive impairment that makes it impossible to perform therapeutic exercise.

Primary outcomes:
measure: Shoulder disability
timeFrame: Baseline, change from baseline to 3-month, change from baseline to 6-month, and change from baseline to 1-year.
Secondary outcomes:
measure: Shoulder pain intensity
timeFrame: Baseline, change from baseline to 3-month, change from baseline to 6-month, and change from baseline to 1-year.
measure: Need for surgery
timeFrame: 3-month, 6-month, and 1-year.
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Hospital Universitario Fundación Alcorcón
Study officials:
References:
Clinical trial NCT03269630: New Orleans Pulmonary Hypertension Biobank
Official title: New Orleans Pulmonary Hypertension Biobank
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Pulmonary Hypertension
Systemic Sclerosis
Mixed Connective Tissue Disease
Heart Failure With Normal Ejection Fraction
Healthy
Lead sponsor: Louisiana State University Health Sciences Center in New Orleans
Sponsor class: OTHER
First posted: 2017-09-01
Enrollment: 450
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects will be enrolled from 2 venues: 1) Comprehensive Pulmonary Hypertension Center clinic (pulmonary hypertension, systemic sclerosis without PH, mixed connective tissue disease without PH) and 2) Outpatient right heart catheterization lab. Healthy subjects (age\>18, not currently smoking, no chronic medical conditions) will also be enrolled.

Brief summary: Pulmonary hypertension (PH) is a serious condition characterized by a mean pulmonary artery pressure \>=25mmHg on right heart catheterization (RHC). Despite advances in PH care, outcomes are still sub-optimal and further research is required into the pathobiology of the disease and development of biomarkers that can guide clinical care. The investigators are establishing a biobank to collect samples (blood, urine, stool) from patients with pulmonary hypertension, patients at high risk for pulmonary hypertension, healthy controls, and patients undergoing right heart catheterization. Specimens will be stored for future investigations.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of pulmonary hypertension and followed at the Comprehensive Pulmonary Hypertension Center OR
* Diagnosis of systemic sclerosis and followed at the Comprehensive Pulmonary Hypertension Center OR
* Diagnosis of mixed connective tissue disease and followed at the Comprehensive Pulmonary Hypertension Center OR
* Undergoing outpatient right heart catheterization

Exclusion Criteria:

* Age\<18
* Pregnant
* Unable to understand English
* Currently incarcerated
* Unwilling or unable to sign informed consent

Primary outcomes:
measure: Collection of biospecimens
timeFrame: 10 years
Secondary outcomes:
Other outcomes:
Locations:
city: New Orleans
country: United States
facility: University Medical Center-New Orleans
state: Louisiana
Study officials:
References:
Clinical trial NCT01527630: Bioequivalence of Two Formulations of Biphasic Insulin Aspart 50 in Healthy Japanese Subjects
Official title: A Randomised, Double-blind, Single-centre, Two-Period Crossover Trial Testing the Bioequivalence of Two Formulations of NN-X14Mix50 in Healthy Japanese Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Diabetes
Diabetes Mellitus, Type 2
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2012-02-07
Enrollment: 30
Sex: MALE
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This trial is conducted in Japan. The aim of this trial is to investigate the bioequivalence of two formulations of biphasic insulin aspart 50 (NN-X14Mix50) in healthy Japanese subjects.


Eligibility criteria: Inclusion Criteria:

* Considered generally healthy upon completion of medical history and physical examination, as judged by the Investigator or Sub-Investigator.
* Body Mass Index (BMI) between 19-29 kg/m\^2 (inclusive)
* Fasting plasma glucose between 3.8-6.0 mmol/L (both inclusive)

Exclusion Criteria:

* Clinically significant abnormal haematology, biochemistry or urinalysis screening tests, as judged by the Investigator or Sub-Investigator
* Any serious systemic infectious disease that had occurred during the 4 weeks prior to the screening, as judged by the Investigator or Sub-Investigator
* Any inter-current illness that might affect blood glucose, as judged by the Investigator or Sub-Investigator
* Hepatitis B or C, or HIV (human immunodeficiency virus) positive
* Subjects with a first degree relative with diabetes mellitus
* History of or presence of diabetes, cancer or any clinically significant cardiac, respiratory, metabolic, renal, hepatic, gastrointestinal, endocrinological, dermatological, venereal, haematologic, neurologic, or psychiatric diseases or disorder
* Subjects who consumed more than 28 units of alcohol per week or who had a significant history of alcoholism or drug/chemical abuse
* Subjects who smoked more than 5 cigarettes per day
* Subjects who had taken part in strenuous exercise within 7 days prior to the screening

Primary outcomes:
measure: Area under the insulin aspart concentration-time curve in the interval from 0 to 16 hours
measure: Cmax, maximum insulin aspart concentration
Secondary outcomes:
measure: Area under the insulin aspart concentration-time curve
measure: Tmax, time to maximum insulin aspart concentration
measure: MRT, mean residence time
measure: t½, terminal half-life
Other outcomes:
Locations:
city: Tokyo
country: Japan
facility: Novo Nordisk Investigational Site
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References: