louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01815866: Cough-Generated Aerosols of NTM in Cystic Fibrosis
Official title: Cough-Generated Aerosols of Nontuberculous Mycobacteria in Patients With Cystic Fibrosis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cystic Fibrosis
Keywords: Positive Nontuberculous Mycobacteria
Lead sponsor: University of Florida
Sponsor class: OTHER
Collaborators: name: Children's Miracle Network
name: UF Peds
First posted: 2013-03-21
Enrollment: 5
Sex: ALL
Minimum age (years): 8
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Specialialty Clinics, Pulmonary

Brief summary: Non-tuberculous mycobacteria (NTM) are opportunistic pathogens normally found in soil and water that are being cultured from Cystic Fibrosis (CF) airways at an increasing frequency. They have been demonstrated to cause clinically significant lung disease in some cases and the transmission of NTM, from person to person has been proposed. There are currently no standardized guidelines for isolation of those colonized or infected with NTM.

The investigators will measure particle droplet size from patients with CF who have positive sputum cultures for NTM with the hypothesis that they will be in a range that can spread infection.

Detailed description: Patients with a positive NTM sputum culture will be asked to participate in the study. If they agree to participate they will sign an informed consent and will be scheduled to come to the University of Florida Clinical Research Center for the testing.

The test will consist of the following: pulmonary function test, collecting a sputum culture if possible, coughing for 5 minutes into a tube connected to a canister, hypertonic saline and albuterol will be given after the 5 minutes of coughing and then they would repeat with another 5 minutes of coughing. There can be a break inbetween the coughing if needed.

Patients maybe asked to come back a second time if they develop a different type of NTM or start treatment for NTM.

Eligibility criteria: Inclusion Criteria:

* Age greater than or equal to age 8 years
* Confirmed Diagnosis of CF
* Sputum/Throat/Bronchoscopic culture positive for NTM within the last 12 months

Exclusion Criteria:

* Pregnancy
* Pneumothorax within the last 6 months
* Forced Expiratory Volume at one second \<30% predicted
* Hemoptysis greater than 1 tablespoon within the last 7 days

Primary outcomes:
measure: The number of CF patients who produce culturable aerosols of NTM during coughing.
timeFrame: 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: University of Florida Clinical Research Center
state: Florida
Study officials:
affiliation: University of Florida
name: Pamela M Schuler, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00682266: High-intensity Exercise Training or Multidisciplinary Treatment in Extremely Obese Adolescents
Official title: Reducing Cardiovascular Risk Factors In Overweight Adolescents: Multidisciplinary Treatment and Intensity Controlled Interval Training
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Cardiovascular Diseases
Keywords: Adolescent
Overweight
Exercise
multidisciplinary approach
Oxygen uptake
Flow mediated dilatation
Cardiovascular Risk Factors
Lead sponsor: Norwegian University of Science and Technology
Sponsor class: OTHER
First posted: 2008-05-22
Enrollment: 54
Sex: ALL
Minimum age (years): 13
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of the present study was to determine the effects of a multidisciplinary approach and intensity-controlled interval training on cardiovascular risk factors in overweight adolescents


Eligibility criteria: Inclusion Criteria:

* BMI \>+ 2SD (age adjusted)
* Fitted for group treatment
* at least one parent attending the treatment

Exclusion Criteria:

* Not able to join treatment
* not able to walk

Primary outcomes:
measure: Flow mediated Diameter Maximal oxygen uptake BMI
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Trondheim
country: Norway
facility: St. Olavs Hospital
Study officials:
affiliation: St. Olavs Hospital
name: Rønnaug Ødegård, Dr.med
role: STUDY_DIRECTOR
References:
citation: Tjonna AE, Stolen TO, Bye A, Volden M, Slordahl SA, Odegard R, Skogvoll E, Wisloff U. Aerobic interval training reduces cardiovascular risk factors more than a multitreatment approach in overweight adolescents. Clin Sci (Lond). 2009 Feb;116(4):317-26. doi: 10.1042/CS20080249.
Clinical trial NCT03430466: Anti PD-L1 Antibody + Anti CTLA-4 Antibody in Combination With Hormone Therapy in Patients With Hormone Receptor Positive HER2-negative Recurrent or Metastatic Breast Cancer
Official title: Phase II Study to Assess Efficacy, Safety & Immunological Biomarker of Anti PD-L1 Antibody + Anti CTLA-4 Antibody in Combination With Hormone Therapy in Patients With Hormone Receptor Positive HER2-negative Recurrent or Metastatic Breast Cancer
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Breast Cancer
Lead sponsor: Kyoto Breast Cancer Research Network
Sponsor class: OTHER
First posted: 2018-02-13
Enrollment: 1
Sex: FEMALE
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The aim of this study is to evaluate the safety and efficacy of anti PD-L1 antibody + anti CTLA-4 antibody in combination with hormone therapy in patients with hormone receptor positive HER2-negative recurrent or metastatic breast cancer.


Eligibility criteria: Inclusion Criteria:

1. Patients aged \>= 20 years at informed consent.
2. Patients who have provided written informed consent themselves.
3. Patients who have metastatic and/or advanced lesion
4. Documentation of ER-positive and/or PR-positive tumor (\>=1% positive stained cells).
5. Patients with cancer confirmed to be HER2-negative.
6. Patients with confirmed menopause
7. Patients who have plans of 2nd hormone therapy.
8. Patients with a measurable lesion based on RECIST 1.1
9. Patients with ECOG PS of 0 to 1.
10. Patients without any severe disorder in the major organs.

Exclusion Criteria:

-

Exclusion Criteria:

1. Active or prior documented autoimmune disease within the past 2 years.
2. Current or prior use of immunosuppressive medication within 28 days before the first dose of durvalumab or tremelimumab
3. Patients with central nervous system metastasis
4. Patients with life-threatening disease.
5. Patients with a history of treatment with anti-PD-1, anti-PD-L1, anti-PD-L2 or anti-CTLA-4 antibody drug.
6. Patients who have received live vaccination within 30 days before start of the investigational products.
7. Patients with a past medical history of pneumonia requiring steroid treatment or with a past medical history of interstitial pneumonia.
8. Patients considered ineligible for participation in this study by their attending physicians.

Primary outcomes:
measure: Response rate based on RECIST1.1
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Kyoto
country: Japan
facility: Kyoto University Hospital
Study officials:
References:
Clinical trial NCT04232566: Investigating the Link Between Type 2 Immunity and NAFLD in Human Obesity
Official title: Investigating the Link Between Type 2 Immunity and NAFLD in Human Obesity- AIM 1
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Obesity, Morbid
NASH - Nonalcoholic Steatohepatitis
Chronic Inflammation
Keywords: obesity
nash
adipose tissue inflammation
insulin resistance
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2020-01-18
Enrollment: 60
Sex: ALL
Minimum age (years): 30
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Fourteen subjects with F=0 (no fibrosis) and forty-six patients undergoing gastric bypass Surgery with confirmed Area under the Receiver Operating Characteristic Curve (AUROC) F\>2 (moderate fibrosis), age 30-70yrs, both genders, BMI greater than 40 kg/m2 will be enrolled in the study.

Brief summary: This study is being done to better understand the relationship between inflammation in adipose tissue (AT), abnormal deposition of fat around the liver and how this affects its appearance and function and ultimately insulin resistance.


Eligibility criteria: Inclusion Criteria:

* Undergoing gastric bypass surgery
* Confirmed AUROC F=0 or F\>2 liver fibrosis
* Age 30-70 years
* BMI greater than 40 kg/m2
* Negative pregnancy test (female only)
* Lab Values: Normal TSH

Exclusion Criteria:

* Autoimmune diseases
* Hepatitis B or C positive
* Heavy alcohol use
* Active smoking history
* Active cancer history
* History of asthma
* History of COPD
* Taking Plavix or Coumadin
* Blood donation within past 2 months
* Glucocorticoid Therapy
* Taking antihistamine on regular basis

Primary outcomes:
measure: Liver fibrosis
timeFrame: Baseline
measure: Adipose tissue inflammation
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: Mayo Clinic in Arizona
state: Arizona
Study officials:
affiliation: Mayo Clinic
name: Elena Anna O De Filippis
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06112366: Comparison of Silk Suture and Tissue Adhesive for Wound Closure After Impacted Tooth
Official title: Comparison of the Efficiency of Tissue Adhesive (Periacryl 90) and Silk Suture in Bilateral Mandibular Impacted Wisdom Teeth Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tooth, Impacted
Tooth Diseases
Keywords: impacted wisdom teeth
tissue adhesive
silk suture
Lead sponsor: Yuzuncu Yıl University
Sponsor class: OTHER
First posted: 2023-11-01
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study was administered to 21 female and 9 male patients. Patients with impacted wisdom teeth on both sides of the mandible were selected. After extraction of the impacted teeth, silk sutures were used on one side and cyanoacrylate tissue adhesive on the other side for wound closure. The effects of these two materials on patient comfort were investigated.

Detailed description: The aim of this study was to compare the effectiveness of tissue adhesive (Periacryl 90) and silk suture in bilateral mandibular impacted wisdom tooth surgery. In the study of 30 patients, 21 females and 9 males, 60 fully impacted lower wisdom teeth were extracted bilaterally and in the same position. One of the bilaretal teeth of the patients was randomly selected and tissue adhesive (Periacryl 90) was applied for wound closure as the experimental group, while the other tooth was selected as the control group and the wound was closed with silk suture. The selected side was determined by a closed envelope procedure. After the first impacted tooth extraction, the patient waited until the wound healed and the symptoms disappeared completely, and then the other tooth was extracted. Both extractions were evaluated on days 3 and 7 for wound healing, edema and trismus. Wound healing was evaluated as good, acceptable and poor. VAS (Visual Analog Scale) was used for pain assessment

Eligibility criteria: Inclusion Criteria:

* Volunteers with bilateral fully impacted mandibular wisdom teeth

Exclusion Criteria:

* Patients were excluded from the study if they did not understand the clinical procedures of the study,
* Had allergies or intolerance to any of the substances used in the study,
* Patients on anticoagulant or psychiatric treatment,
* Pregnant or breastfeeding,
* Patients using oral contraceptiveswere,
* Diabetic,
* Patients with periodontal disease or active infection,
* Poor oral hygiene

Primary outcomes:
measure: Mouth opening measurements
timeFrame: 0-28 days
measure: Facial edema
timeFrame: 0-28 days
measure: Wound healing
timeFrame: 0-28 days
measure: Visual Analog Scale
timeFrame: 0-28 days
Secondary outcomes:
Other outcomes:
Locations:
city: Van
country: Turkey
facility: Serap Keskin Tunc
Study officials:
References:
Clinical trial NCT02233166: OSA in Children Referred for Adenotonsillectomy
Official title: Obstructive Sleep Apnea in Children Referred for Adenotonsillectomy
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Obstructive Sleep Apnea
Lead sponsor: Lovisenberg Diakonale Hospital
Sponsor class: OTHER
First posted: 2014-09-08
Enrollment: 115
Sex: ALL
Minimum age (years): 2
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Children aged between 2 and 5 years who are referred for adenoidectomy and/or tonsillectomy.

Brief summary: In children with OSA (Obstructive sleep apnea) adenotonsillectomy is regarded as the first choice of treatment. Studies in recent years have shown that the procedure does not always have the expected effect. Children with OSA are at greater risk for complications from the procedure.

There is disagreement regarding the need for sleep studies in children prior to surgery in order to verify an OSA diagnosis. Today less than 10% of these children have polysomnography (PSG).

The main purpose of this study is to describe the prevalence of OSA among children referred for adenotonsillectomy.

The investigators will also examine these children prior to and six months after surgery to assess their sleep pattern and quality of life.

The project outcome aims to improve the precision and quality of diagnosis and the short and long term effects of treatment of children with OSA.


Eligibility criteria: Inclusion Criteria:

* age 2-5 year
* referred for adenoidectomy and/or tonsillectomy

Exclusion Criteria:

* craniofacial anomalies
* neurological diseases
* neuropsychiatric diseases

Primary outcomes:
measure: Prevalence of OSA
timeFrame: Up to 2 years
Secondary outcomes:
measure: Post operative PSG results
timeFrame: Up to 2 years
Other outcomes:
measure: Quality of life
timeFrame: Up to 2 years
measure: Risk factors of OSA
timeFrame: Up to 2 years
measure: Post operative complications
timeFrame: Up to 2 years
Locations:
city: Oslo
country: Norway
facility: Lovisenberg Diakonale Hospital
Study officials:
References:
citation: Overland B, Berdal H, Akre H. Correlations between disease-specific quality of life and polysomnographic findings in children with obstructive sleep apnea. Int J Pediatr Otorhinolaryngol. 2020 Jul;134:110077. doi: 10.1016/j.ijporl.2020.110077. Epub 2020 Apr 30.
Clinical trial NCT00674466: A Study to Evaluate the Efficacy and Safety of CJC-1134-PC in Patients With Type 2 Diabetes Who Are Currently on Metformin Monotherapy
Official title: A Randomized, Double-blind, Placebo-controlled, Multiple-dose, Phase II Study to Evaluate the Efficacy and Safety of 3 Months of Twice-a-week Injections of CJC-1134-PC in Patients With Type 2 Diabetes Mellitus on Metformin Monotherapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Type 2 Diabetes Mellitus
Keywords: GLP-1, incretin, type 2 diabetes
Lead sponsor: ConjuChem
Sponsor class: INDUSTRY
First posted: 2008-05-07
Enrollment: 90
Sex: ALL
Minimum age (years): 25
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a multicenter, randomized, placebo-controlled, double-blind, Phase II study. The objective of this study is to evaluate the efficacy and safety of 12 weeks of treatment with CJC-1134-PC in patients who are currently on metformin monotherapy.


Eligibility criteria: Major Inclusion Criteria:

* BMI: 27 to 45 kg/m2
* Stable Type 2 diabetes mellitus for at least 3 months, as defined by the Investigator
* Stable life-style, i.e. diet \& physical activity, as determined by the Investigator
* Stable metformin daily dose ≥1000 mg for at least 3 months
* Glycosylated hemoglobin (HbA1c) at screening ≥ 7.1% and ≤ 11%

Primary outcomes:
measure: Reduction of HbA1c From Baseline
timeFrame: Screening and Day 85
Secondary outcomes:
measure: Reduction in Fasting Plasma Glucose From Baseline
timeFrame: Screening and Day 85
measure: Reduction in Fasting Body Weight From Baseline
timeFrame: Screening and Day 85
Other outcomes:
Locations:
city: Montreal
country: Canada
facility: Maggie Wang
state: Quebec
Study officials:
affiliation: ConjuChem Biotechnologies Inc.
name: Maggie Wang, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT01384266: A Comparison of 0.5% Loteprednol Etabonate Versus 1% Prednisolone Acetate Following Cataract Surgery
Official title: A Randomized, Multicenter, Masked Evaluation of 0.5% Loteprednol Etabonate Versus 1% Prednisolone Acetate for the Treatment of Inflammation Following Cataract Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Intraocular Inflammation
Keywords: Intraocular Inflammation following routine Cataract Surgery
Lead sponsor: Associated Eye Care, Minnesota
Sponsor class: OTHER
Collaborators: name: Bausch & Lomb Incorporated
First posted: 2011-06-29
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Eye Clinic

Brief summary: Patients are routinely given steroid eye drops following cataract surgery. This study will compare 2 approved drops:Loteprednol Etabonate versus Prednisolone Acetate Eye drops used following cataract surgery. Patients will be randomly assigned to one drop or the other, and evaluated for inflammation and intraocular pressure as part of the comparison. The study Doctor will be masked as to which drop the patient receives to avoid bias.


Eligibility criteria: Inclusion Criteria:

* Subjects age 18 and older undergoing routine cataract surgery.

Exclusion Criteria:

1. Subjects being treated for elevated intraocular pressure, retinopathy, maculopathy, cornea or vitreous opacities that would interfere with visual acuity.
2. Subjects with diabetes, pseudoexfoliation, uveitis, corneal endothelial disease, or active Herpes Simplex Virus(HSV) or Herpes Zoster Virus(HZV) Pupil Stretch and/or Limbal Relaxing Incision(LRIs) will be allowed.
3. Subjects with previous ocular trauma or intraocular surgery
4. Subjects with sensitivities to steroids.
5. Women who are not post-menopausal or are of child bearing potential will be excluded.
6. Intraoperative complications during surgery including posterior capsule rupture and vitreous loss
7. Subjects with best visual potential in the fellow eye worse than 20/60
8. Subjects who are expected to require concurrent ocular or systemic therapy with non-steroidal anti-inflammatory drugs (NSAIDS) mast cell stabilizers, antihistamines, or decongestants within 2 days prior to or during the 21 days following surgery. (Intraoperative NSAIDS for mydriasis are permitted.) 325 mg Aspirin is permitted.
9. Subjects who are expected to require concurrent ocular or systemic corticosteroids, immunosuppressants (including Restasis) within 14 days prior to or 21 days following surgery

Primary outcomes:
measure: Intraocular inflammation grading
timeFrame: Day 21 Post-op
Secondary outcomes:
measure: Intraocular pressure spikes
timeFrame: Day 21 post-op
Other outcomes:
Locations:
city: Edgewood
country: United States
facility: Cincinnati Eye Institute
state: Kentucky
city: Stillwater
country: United States
facility: Associated Eye Care
state: Minnesota
Study officials:
affiliation: Associated Eye Care
name: Stephen S Lane, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00601666: Bioequivalency Study of Zolpidem Tartrate Under Fasting Conditions
Official title: A Single Dose, Two-Period, Two-Treatment, 2-Way Crossover Bioequivalency Study of Zolpidem Tartrate Tablets 10 MG Under Fasting Conditions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Insomnia
Lead sponsor: West-Ward Pharmaceutical
Sponsor class: INDUSTRY
First posted: 2008-01-28
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The objective of this study was the bioequivalence of a Roxane Laboratories' Zolpidem Tablets, 10 mg, to Ambien® Tablets, 10 mg (Sanofi-Synthelabo Inc.) under fasting conditions using a single-dose, randomized, 2-treatment, 2-period, 2-sequence crossover design.


Eligibility criteria: Inclusion Criteria:

* No clinically significant abnormal findings on the physical examination, medical history, or clinical laboratory results during screening.

Exclusion Criteria:

* Positive test for HIV, Hepatitis B, or Hepatitis C.
* Treatment with known enzyme altering drugs.
* History of allergic or adverse response to Zolpidem or any comparable or similar product.

Primary outcomes:
measure: Bioequivalence
timeFrame: Baseline, Two period, Seven day washout
Secondary outcomes:
Other outcomes:
Locations:
city: Fargo
country: United States
facility: PRACS Institute, Ltd.
state: North Dakota
Study officials:
affiliation: PRACS Institute, Ltd.
name: Alan K Copa
role: PRINCIPAL_INVESTIGATOR
References: