louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00446121: Inhaled Mannitol and Ciliary Beat Frequency in COPD Patients
Official title: The Effect of Inhaled Mannitol on Ciliary Beat Frequency in COPD Patients
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: COPD
Lead sponsor: Imperial College London
Sponsor class: OTHER
First posted: 2007-03-12
Enrollment: 0
Sex: ALL
Minimum age (years): 38
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients with COPD

Brief summary: The main purpose of the study is to evaluate the effect of mannitol on the cilia's beat frequency (ciliary beat frequency) in COPD patients.


Eligibility criteria: Inclusion Criteria:

* COPD

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Airway Disease Section, Asthma Lab, Imperial College London, Royal Brompton Hospital
Study officials:
affiliation: Imperial College London
name: Sergei Kharitonov, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04606121: The Benefit of Enhanced Day Care of Traditional Chinese Medicine: A Retrospective Study of Medical Records
Official title: The Benefit of Enhanced Day Care of Traditional Chinese Medicine: A Retrospective Study of Medical Records
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chemotherapy-Induced Change
Lead sponsor: Taipei City Hospital
Sponsor class: OTHER_GOV
First posted: 2020-10-28
Enrollment: 401
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: cancer patients who needed to accept surgery, or chemotherapy, or radiotherapy, or other conventional cancer therapy

Brief summary: We collected medical records since June 2017 to November 2019., used pair-T test for questionnaire of CTCAE, BFT-I, WHOQOL to evaluate the benefit of enhanced day care of TCM for cancer patients.

Detailed description: using TCM method as Complementary and Alternative Medicine is worldwide. we collected medical records that using TCM methods for adverse event from cancer therapies. we used CTCAE BFI-T and WHOQOF-BREF to evaluate the benefit.

Eligibility criteria: Inclusion Criteria:

- The medical records since June 2017 to December 2019 needed to meet the following criterial: (1)age\>20 years old, (2)diagnosis meet ICD10:C00.0-C97 (3) needed to do Taiwan brief version of Common Terminology Criteria for Adverse Events Version4.0(Taiwan brief version scale of CTCAE), scale of the Taiwanese Version of the Brief Fatigue Inventory(BFI-T) and scale of the World Health Organization Quality of Life-BREF(WHOQOL-BREF), and those scales needed to be done pretest when patient came to the clinics and posttest when case end.

Exclusion Criteria:

- The subjects will be excluded if they do not complete pretest and posttest of the following scales:(1) Taiwan brief version scale of CTCAE, (2) BFI-T scale (3) WHOQOL-BREF scale

Primary outcomes:
measure: scale of Taiwan brief version of Common Terminology Criteria for Adverse Events Version4.0(Taiwan brief version scale of CTCAE)
timeFrame: 2020
Secondary outcomes:
measure: scale of the Taiwanese Version of the Brief Fatigue Inventory(BFI-T)
timeFrame: 2020
measure: scale of the World Health Organization Quality of Life-BREF(WHOQOL-BREF)
timeFrame: 2020
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Taipei city hospital
Study officials:
References:
citation: Wu HA, Chen CH, Hsieh MH, Wu YC, Chiu JP, Huang CJ, Hsu CH. The Benefit of Enhanced Daycare of Traditional Chinese Medicine for Cancer Treatment Related Adverse Events: A Retrospective Study of Medical Records. Integr Cancer Ther. 2021 Jan-Dec;20:15347354211025634. doi: 10.1177/15347354211025634.
Clinical trial NCT00989521: Effect of PUR003 on Asthma
Official title: Double-blind, Placebo-controlled Crossover Evaluation of the Effect of PUR003 on Subjects With Asthma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Asthma
Lung Diseases
Bronchial Diseases
Keywords: Asthma
bronchial diseases
lung diseases
bronchitis
respiratory tract diseases
Lead sponsor: Pulmatrix Inc.
Sponsor class: INDUSTRY
Collaborators: name: St. Joseph's Healthcare Hamilton / Firestone Institute for Respiratory Health
name: McMaster University
First posted: 2009-10-05
Enrollment: 7
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: PUR003 is an inhaled substance that is proposed to assist in the treatment of asthma.

Study objectives are to :

1. to evaluate the safety of PUR003 in subjects with asthma, and
2. to evaluate the efficacy of PUR003 in assisting the treatment of asthma.


Eligibility criteria: Inclusion Criteria:

1. Signed written informed consent.
2. Ability and willingness to return to the outpatient clinic for repeated clinic visits and complete all assessments.
3. Adult male or female subject, 18-60 years of age.
4. Stable, mild asthma not requiring any medical treatment other than short acting inhaled bronchodilators, as needed.
5. No smoking within six months prior to entry
6. Must be medically stable.
7. Female subjects must have a negative pregnancy test
8. Subjects of child bearing potential should be sexually inactive (abstinent) for 14 days prior to the first dose of study medication or using an acceptable form of birth control methods.

Exclusion Criteria:

1. History or presence of significant co-existing chronic diseases.
2. History of asthma exacerbations or upper or lower respiratory illness (viral respiratory syndrome, bronchitis, pneumonia) within four weeks of first visit.
3. Pregnancy, breastfeeding.
4. Abused alcohol or illicit drugs that required treatment.
5. Participated in any other investigational drug evaluation within last 30 days.
6. Scheduled to have elective or invasive medical intervention, procedure, or surgery within 6 months.

Primary outcomes:
measure: Safety and tolerability of PUR003 as determined by incidence of adverse events (AEs); changes in physical examination, chest examination; pulmonary function; vital signs; electrocardiogram (ECG) and clinical laboratory assessments.
timeFrame: after three doses
Secondary outcomes:
Other outcomes:
Locations:
city: Hamilton
country: Canada
facility: Firestone Institute for Respiratory Health
state: Ontario
Study officials:
affiliation: St. Joseph's Healthcare Hamilton / Firestone Institute for Respiratory Health
name: Parameswaran Nair, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00586521: BAY14-2222 Prophylaxis and Joint Function Improvement (Adults)
Official title: A Prospective Controlled Study on the Effect on Bleeding Events and Joint Function in Young Adults With Severe Hemophilia A After a 6 Month Prophylaxis Treatment Compared to on Demand Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hematologic Disease
Hemophilia A
Keywords: Coagulation Disorders
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2008-01-04
Enrollment: 20
Sex: MALE
Minimum age (years): 30
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to evaluate the effect of prophylactic treatment on the number of joint bleeds and quality of life in severe hemophilia A subjects compared to on-demand treatment in a one-group two-treatment schedule design.

In addition, the effect of prophylactic treatment on the joint function, the number of all bleeds, and on the quality of life compared to on-demand treatment and health-economic data will be assessed.


Eligibility criteria: Inclusion Criteria:

* Severe hemophilia A (\< 1% FVIII)
* 30-45 years of age
* Previously treated subject (\> 100 Exposure days to any FVIII)
* On-demand therapy with any FVIII

Exclusion Criteria:

* No history of inhibitor
* No planned elective orthopedic surgery during the study duration (13 months)
* No severe concomitant disease
* No history of anaphylactic or other severe reaction to previous FVIII treatment

Primary outcomes:
measure: Number of Joint Bleeds
timeFrame: Months 1-6 (on-demand treatment) and 8-13 (prophylactic treatment)
Secondary outcomes:
measure: Number of All Bleeds
timeFrame: Months 1-6 (on-demand treatment) and 8-13 (prophylactic treatment)
measure: Physical Assessment Compared to On-demand Treatment as Determined by the Gilbert Score
timeFrame: Month 13 (end of prophylactic treatment) and Month 6 (end of on-demand treatment)
measure: Quality of Life Compared to On-demand Treatment as Measured by the Haemo-QoL A Questionnaire
timeFrame: Month 13 (end of prophylactic treatment) and Month 6 (end of on-demand treatment)
Other outcomes:
Locations:
city: Aurora
country: United States
state: Colorado
city: Chapel Hill
country: United States
state: North Carolina
city: Houston
country: United States
state: Texas
city: Strasbourg
country: France
city: Firenze
country: Italy
city: Pavia
country: Italy
city: Roma
country: Italy
city: Sta. Cruz de Tenerife
country: Spain
state: Santa Cruz de Tenerife
city: Madrid
country: Spain
city: Cardiff
country: United Kingdom
state: South Glamorgan
city: Sheffield
country: United Kingdom
state: South Yorkshire
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT02826421: Clinical Investigation of Corneal Incision Size After Intraocular Lens (IOL) Implantation
Official title: Clinical Investigation of Corneal Incision Size After IOL Implantation With Preloaded Delivery Devices and a Manual Delivery Device
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cataracts
Keywords: Intraocular lens
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2016-07-11
Enrollment: 114
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare corneal incision size after IOL implantation with the use of one of four IOL delivery systems (three preloaded IOL delivery systems and one manually loaded IOL delivery system).


Eligibility criteria: Inclusion Criteria:

* Able to comprehend and sign a statement of informed consent;
* Willing and able to complete all required postoperative visits;
* Cataract;
* Planned cataract removal by phacoemulsification;
* Calculated lens power from 18.0 through 27.0 D inclusive;
* Preoperative astigmatism \<1.0D;
* Other protocol-specified inclusion criteria may apply.

Exclusion Criteria:

* Systemic disease that affects the cornea;
* Any inflammation or edema of the cornea;
* Previous or planned refractive or corneal surgery during the subject's participation in the study;
* Previous corneal transplant;
* Previous retinal detachment;
* Pregnancy or lactation, current or planned, during the course of the study;
* Current participation in another investigational drug or device study that may confound the results of this investigation;
* Any condition observed before or during surgery that in the surgeon's medical opinion may affect the success of the cataract surgery;
* Other protocol-specified exclusion criteria may apply.

Primary outcomes:
measure: Mean Corneal Incision Size After IOL Implantation (UltraSert, iTec, and iSert)
timeFrame: Day 0, operative day
Secondary outcomes:
measure: Mean Corneal Incision Size After IOL Implantation (UltraSert and Monarch III D)
timeFrame: Day 0, operative day
Other outcomes:
Locations:
Study officials:
affiliation: Alcon Research
name: Sr. Clinical Manager, GCRA
role: STUDY_DIRECTOR
References:
Clinical trial NCT05224921: Peripherel Perfusion Index to Predict Sepsis in Very Low Birth Weight Infants
Official title: Study of Peripherel Perfusion Index to Predict Late Onset Sepsis in Very Low Birth Weight Infants
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: VLBW - Very Low Birth Weight Infant
Keywords: Late onset sepsis
Peripheral perfusion index
Lead sponsor: Children's Hospital of Fudan University
Sponsor class: OTHER
First posted: 2022-02-04
Enrollment: 216
Sex: ALL
Minimum age (years): 0
Maximum age (years): 3
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Infant's birth weight \<1500g

Brief summary: To explore the predictive value of peripheral perfusion index in late onset sepsis of very low birth weight infants , obtain the threshold by observing the perfusion index of very low birth-weight infants within one month after birth, this value can be used as a threshold to predict late onset sepsis in very low birth weight infants.

Detailed description: From the day the very low birth weight infant was admitted to hospital, monitoring was recorded once a day, and continuous monitoring was recorded for 1 month. Before collection, the infant was confirmed to be in supine position with neutral temperature, and at the same time, the infant was in a quiet state, without the contact and operation of medical personnel. This study will first use LMS curve to fit the trend of perfusion index in very low birth weight infants within one month after birth.The perfusion index threshold of the outcome index was determined by ROC curve.

Eligibility criteria: Inclusion Criteria:

* Infants weighting \<1500g
* Infants admitted to Children's Hospital of Fudan University

Primary outcomes:
measure: Incidence of late onset sepsis
timeFrame: From admission into the ward to one month after birth
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Children's Hospital of Fudan University
state: Shanghai
Study officials:
References:
Clinical trial NCT01324921: Effect of Nutritional Products on Metabolic Parameters in Subjects With Type 2 Diabetics
Official title: Effect of Nutritional Products on Metabolic Parameters in Subjects With Type 2 Diabetics
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Diabetes Mellitus, Type 2
Lead sponsor: Abbott Nutrition
Sponsor class: INDUSTRY
First posted: 2011-03-29
Enrollment: 37
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: To compare the postprandial glycemic and insulinemic response of subjects with type 2 diabetes consuming a typical breakfast meal or no breakfast to 10004RF via a meal tolerance test (MTT).


Eligibility criteria: Inclusion Criteria:

1. type 2 diabetes
2. between 21 and 75 years of age
3. male or a non-pregnant, non-lactating female, at least 6 weeks postpartum or postmenopausal or surgically sterile
4. BMI is \> 18.5 kg/m2 and \<35 kg/m2
5. If subject is on a chronic medication such as an anti-hypertensive, lipid-lowering, thyroid medication or hormone therapy, they have been on constant dosage for at least two months prior to screening visit.

Exclusion Criteria:

1. Hemoglobin A1c value at screening of greater than or equal to 9%.
2. Uses exogenous insulin or exenatide for glucose control.
3. type 1 diabetes.
4. history of diabetic ketoacidosis.
5. current infection; has had inpatient surgery, or corticosteroid treatment in the last 3 months or antibiotics in the last 3 weeks prior to screening visit.
6. active malignancy
7. significant cardiovascular event ≤ six months prior to screening visit; or stated history of congestive heart failure.
8. end-stage organ failure or is status post organ transplant.
9. history of renal disease.
10. current hepatic disease.
11. history of severe gastroparesis.
12. chronic, contagious, infectious disease
13. taking any herbals, dietary supplements, or medications, other than anti-hyperglycemic medications, that could profoundly affect blood glucose.
14. clotting or bleeding disorders
15. allergic or intolerant to any ingredient found in the study products.
16. habitual user of tobacco products (

Primary outcomes:
measure: Positive AUC for plasma glucose concentration
timeFrame: 0 to 180 minutes
Secondary outcomes:
measure: Plasma glucose concentrations
timeFrame: 0 to 180 minutes
measure: Positive AUC for serum insulin concentration
timeFrame: 0-180 minutes
Other outcomes:
Locations:
city: Glen Ellyn
country: United States
facility: Provident Clinical Research and Consulting LLC
state: Illinois
city: Cincinnati
country: United States
facility: Radiant Research
state: Ohio
Study officials:
affiliation: Abbott Nutrition
name: Amy Devitt-Maicher, PhD
role: STUDY_CHAIR
References:
citation: Lohner S, Kuellenberg de Gaudry D, Toews I, Ferenci T, Meerpohl JJ. Non-nutritive sweeteners for diabetes mellitus. Cochrane Database Syst Rev. 2020 May 25;5(5):CD012885. doi: 10.1002/14651858.CD012885.pub2.
Clinical trial NCT04158921: Control:Diabetes Pilot Study I
Official title: Control:Diabetes - a Mobile App to Improve Glycemic Control in Patients With Diabetes
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Insulin Treated Type 2 Diabetes Mellitus
Diabetes Mellitus, Type 1
Keywords: Diabetes Mellitus
Insulin Therapy
Glycemic Control
Hyperglycemia
Hypoglycemia
Health Education
Self-Management
Lifestyle
Lead sponsor: Brigham and Women's Hospital
Sponsor class: OTHER
First posted: 2019-11-12
Enrollment: 55
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a single arm open label pilot clinical trial that will assess patient-reported blood glucose levels before and after using the Control:Diabetes mobile app, while collecting user feedback and recommendations for further improvements to the app functionality and user interface. This study will enroll approximately 70 individuals with insulin-treated diabetes mellitus. The study will include two online surveys (baseline and exit), one study initiation phone call, and will also collect data entered by the users into the mobile app.

Detailed description: The objectives of this study are to:

* Test the hypothesis that patients with diabetes mellitus treated with insulin and elevated blood glucose will achieve better glycemic control after using the Control:Diabetes mobile app.
* Test the hypothesis that patients with diabetes mellitus treated with insulin and frequent hypoglycemia will achieve lower frequency of hypoglycemia after using the Control:Diabetes mobile app.

Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 years
* Diagnosis of Type 1 Diabetes or Type 2 Diabetes
* Treatment with multiple daily insulin injections (MDII) or continuous subcutaneous insulin infusion (CSII)
* Baseline HbA1c between 7% and 10.5% (as reported by the participant) and/or self- reported frequency of symptomatic hypoglycemia ≥ 3 times / week
* Ownership of a smartphone running either Android or iOS operating system with an active data plan

Exclusion Criteria:

* Using a closed loop insulin delivery system (Medtronic 670G or OpenAPS)

Primary outcomes:
measure: The mean change in blood glucose.
timeFrame: Measured between the first two weeks and the last two weeks of the study.
Secondary outcomes:
measure: The change in the number of hypoglycemic episodes.
timeFrame: Measured every week between the two weeks prior to the study entry and the last two weeks of study follow-up.
Other outcomes:
Locations:
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
Study officials:
References:
Clinical trial NCT00271921: Does Metabolic Syndrome Exist in Anorexia Nervosa?
Official title: Does Metabolic Syndrome Exist in Anorexia Nervosa?
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Anorexia Nervosa
Metabolic Syndrome
Keywords: eating disorders
anorexia nervosa
body fat distribution
metabolic syndrome
visceral adipose tissue
Lead sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Sponsor class: NIH
First posted: 2006-01-04
Enrollment: 50
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE

Brief summary: The purpose of this study is to examine whether body fat distribution changes that occur with weight gain in women recovering from anorexia nervosa are transient or persistent, and if they are associated with other features of Metabolic Syndrome.


Eligibility criteria: Inclusion Criteria:

* DSM-IV diagnosis of Anorexia Nervosa (except amenorrhea) (restricting or binge eating/purging subtype)
* Female
* Age 18-40
* Medically stable
* Participation in inpatient or daypatient treatment sufficient to restore patient to a BMI of at least 19.5kg/m²

Exclusion Criteria:

* Additional Major Axis I disorder (including substance abuse or dependence
* On daily prescription medication (including oral contraceptives)
* History of suicide attempt or other self-injurious behavior within the previous 6 months
* Significant current or past medical illness,including diabetes mellitus, heart disease
* Indwelling metallic object (e.g., pacemaker,pump), non-removable metal jewelry or recent metallic ink tattoo

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: St. Luke's Roosevelt Hosptial Center
state: New York
city: New York
country: United States
facility: New York State Psychiatric Institute/Columbia University
state: New York
Study officials:
affiliation: New York State Psychiatric Institute/Columbia University
name: Laurel Mayer, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Columbia University
name: Henry Ginsberg, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Schebendach J, Mayer LE, Devlin MJ, Attia E, Walsh BT. Dietary energy density and diet variety as risk factors for relapse in anorexia nervosa: a replication. Int J Eat Disord. 2012 Jan;45(1):79-84. doi: 10.1002/eat.20922. Epub 2011 Mar 29.
citation: Bodell LP, Mayer LE. Percent body fat is a risk factor for relapse in anorexia nervosa: a replication study. Int J Eat Disord. 2011 Mar;44(2):118-23. doi: 10.1002/eat.20801.
citation: Mayer LE, Klein DA, Black E, Attia E, Shen W, Mao X, Shungu DC, Punyanita M, Gallagher D, Wang J, Heymsfield SB, Hirsch J, Ginsberg HN, Walsh BT. Adipose tissue distribution after weight restoration and weight maintenance in women with anorexia nervosa. Am J Clin Nutr. 2009 Nov;90(5):1132-7. doi: 10.3945/ajcn.2009.27820. Epub 2009 Sep 30.