louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02703051: A Study to Evaluate the PK, Safety and Tolerability of GMI-1271 With and Without Filgrastim in Healthy Adult Subjects
Official title: A Phase 1, Open-Label Study to Evaluate the Pharmacodynamics, Safety and Tolerability of GMI-1271 With and Without Filgrastim in Healthy Adult Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Lead sponsor: GlycoMimetics Incorporated
Sponsor class: INDUSTRY
Collaborators: name: Celerion
First posted: 2016-03-09
Enrollment: 54
Sex: ALL
Minimum age (years): 19
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: Phase 1, open-label, parallel, active-controlled, multiple IV dose, proof of concept study conducted at one study center in the United States (US).


Eligibility criteria: Inclusion Criteria:

1. Healthy adult male and/or females, 19 to 60 years of age, inclusive.
2. Medically healthy with no clinically significant screening results as deemed by the PI.

Exclusion Criteria:

1. History of presence of clinically significant medical condition or disease in the opinion of the PI.
2. Alcoholism or drug abuse.
3. Liver disease.
4. Female subjects who are pregnant or lactating.
5. Known history or evidence of active hepatitis A, B, or C or HIV.
6. Clinically significant cardiovascular disease.
7. Participation in another clinical trial within 28 days prior to the first dose of GMI-1271 or filgrastim, whichever occurs first.

Primary outcomes:
measure: Measurement of subsets of WBC
timeFrame: 10 days
Secondary outcomes:
measure: Number of adverse events as a measure of safety and tolerability
timeFrame: 19 days
Other outcomes:
Locations:
city: Lincoln
country: United States
facility: Celerion
state: Nebraska
Study officials:
affiliation: Celerion
name: Laura Sterling, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01825551: The Effect of GCSF in the Treatment of ALS Patients
Official title: The Effect of Granulocyte Colony Stimulating Factor (GCSF) in the Treatment of Amyotrophic Lateral Sclerosis (ALS) Patients Referred to Tehran Imam Khomeini and Shariati Hospital Centers in 2013
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Amyotrophic Lateral Sclerosis
Keywords: Amyotrophic Lateral Sclerosis
Granulocyte Colony Stimulating Factor
Lead sponsor: Tehran University of Medical Sciences
Sponsor class: OTHER
First posted: 2013-04-05
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is to evaluate the effect off Granulocyte Colony Stimulating Factor (GCSF) in the treatment of Amyotrophic Lateral Sclerosis (ALS) patients.


Eligibility criteria: Inclusion Criteria:

* age between 18 and 85
* definite or probable ALS according to revised El Escorial criteria
* maximum 2 years from initiation of symptoms to study entry
* mild to moderate disability according to revised ALS functional rating scale (ALSFRS-r)

Exclusion Criteria:

* familial ALS
* pregnancy or lactation
* myeloproliferative or hematologic disorders
* active immunological disease
* liver or renal or heart disease
* HIV positive
* significant cognitive disorder
* hypersensitivity to GCSF

Primary outcomes:
measure: patient's function
timeFrame: one year
Secondary outcomes:
measure: mobilizing bone marrow stem cells
timeFrame: 1 year
measure: amplitude of compound muscle action potential in ulnar and peroneal nerve
timeFrame: 1 year
measure: quality of life
timeFrame: 1 year
measure: muscle power
timeFrame: 1 year
Other outcomes:
Locations:
city: Tehran
country: Iran, Islamic Republic of
facility: Iranian Neurology Research Center of Tehran University of Medical Sciences
Study officials:
References:
Clinical trial NCT02159651: A Survey for Long-term Use of Prograf Capsules in Patient With Interstitial Pneumonia
Official title: Specified Drug Use-results Survey for Long-term Use of Prograf Capsules in Patient With Interstitial Pneumonia Associated With Polymyositis/Dermatomyositis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Interstitial Pneumonia Associated With Polymyositis/Dermatomyositis
Keywords: tacrolimus
interstitial pneumonia
prograf
Lead sponsor: Astellas Pharma Inc
Sponsor class: INDUSTRY
First posted: 2014-06-10
Enrollment: 179
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with interstitial pneumonia associated with polymyositis/dermatomyositis who treated with Prograf

Brief summary: This study is to evaluate the safety and the efficacy of Prograf in patients with interstitial pneumonia associated with polymyositis / dermatomyositis in acute clinical setting.


Eligibility criteria: Inclusion Criteria:

* Hospitalized patient
* Patient diagnosed with Interstitial pneumonia associated with polymyositis/dermatomyositis

Primary outcomes:
measure: Overall survival
timeFrame: Up to three years
Secondary outcomes:
measure: Respiratory function test value (%FVC, %DLco)
timeFrame: Up to three years
measure: Arterial blood gas analysis value (PaO2, AaDO2)
timeFrame: Up to three years
measure: Chest CT findings
timeFrame: Up to three years
measure: Serum KL-6 value (serum SP-D value)
timeFrame: Up to three years
measure: Patient disposition
timeFrame: Up to three years
measure: Safety assessed by the incidence of adverse events
timeFrame: Up to three years
Other outcomes:
Locations:
city: Chubu
country: Japan
city: Chugoku
country: Japan
city: Hokkaido
country: Japan
city: Kansai
country: Japan
city: Kanto
country: Japan
city: Kyushu
country: Japan
city: Shikoku
country: Japan
city: Tohoku
country: Japan
Study officials:
affiliation: Astellas Pharma Inc
name: Medical Director
role: STUDY_DIRECTOR
References:
citation: Kuwana M, Wakasugi N, Furuya T, Uno S, Suda T. Tacrolimus in Patients With Interstitial Pneumonia Associated With Polymyositis or Dermatomyositis: Interim Report of Postmarketing Surveillance in Japan. J Rheumatol. 2022 Jul;49(7):707-718. doi: 10.3899/jrheum.210322. Epub 2022 Apr 15.
Clinical trial NCT01387451: The Detection and Factors of Brown Adipose Tissue in Different Locations of Adults
Official title: Cross Sectional Study on the Detection and Factors of Brown Adipose Tissue in Different Locations of Adults
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Obesity
Keywords: Brown adipose tissue
Different regions
Chinese adults
Lead sponsor: Huashan Hospital
Sponsor class: OTHER
First posted: 2011-07-04
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects who underwent surgical therapy from 2010 to 2013 in Huashan Hospital and the operation scope includes brown adipose tissue sample sites.

Brief summary: Retrospective studies have combined positron-emission tomography and computed tomography (PET-CT) to identify adipose tissue with a high rate of uptake of 18F-fluorodeoxyglucose(18F-FDG) as active brown adipose tissue(BAT). In addition, biopsy specimens and immunohistochemical staining with a UCP1-specific antiserum were used to indicate that normal adults were able to have BAT. However,these studies only chose few subjects and limited to the neck tissue. Therefore, the investigators intend to test BAT in different parts of adults and analyse the clinical factors.

Detailed description: The investigators will promote the cross-sectional study from 2010 to 2013 in Shanghai. Data on demographic statistics, medical history,physical examination and fasting blood sample will be collected for all patients. Adipose tissue of adults will be collected from different regions, such as cervical, perirenal, along the large blood vessels and trachea, because they are included in the range of surgical therapy and are the major locations of BAT. Adipose tissue samples will be used to immunohistochemical stain, to detect the expression of BAT related genes.

Eligibility criteria: Inclusion Criteria:

* Subjects who underwent surgical therapy and the operation scope includes BAT sample sites.

Exclusion Criteria:

* Pregnant women
* With implantable medical electronic instrument
* Younger than 18 years

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Huashan Hospital
state: Shanghai
Study officials:
affiliation: Huashan Hospital
name: Yiming Li, Doctor
role: STUDY_CHAIR
References:
Clinical trial NCT01742351: Internet-based Cognitive Behaviour Therapy (CBT) for Persons Diagnosed With Bipolar II
Official title: Internet-based Cognitive Behaviour Therapy for Persons Diagnosed With Bipolar II - a Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bipolar Disorder, Type II
Lead sponsor: Örebro County Council
Sponsor class: OTHER_GOV
Collaborators: name: School of Law, Psychology and Social Work, Örebro University
First posted: 2012-12-05
Enrollment: 7
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: The aim of the study is to test the feasibility and acceptability of internet-based Cognitive Behaviour Therapy (CBT) for persons diagnosed with bipolar disorder, type II. The idea is to treat residual depressive symptoms as well as using psychoeducation to improve their prognosis. Each participant will have a personal therapist that will provide guidance and support throughout the treatment.


Eligibility criteria: Inclusion Criteria:

* A diagnosis of bipolar disorder type II
* Mild to moderate depressive symptoms
* 18 years of age
* Stable medication with a mood stabiliser
* Access to the internet

Exclusion Criteria:

* Diagnosis of psychosis
* Having received psychiatric in-patient care during the past year
* Ongoing psychotherapy
* Previous manic episode
* Previous suicide attempt
* Previous parasuicidal behavior documented in patient record (e.g. self-injury)

Primary outcomes:
measure: Change in score on the Montgomery-Åsberg Depression Rating Scale - Self rated (MADRS-S) between baseline and post treatment
timeFrame: 9 weeks
Secondary outcomes:
measure: Change in the score on the Affective Self Rating Scale (AS-18-M) between baseline and post treatment
timeFrame: 9 weeks
Other outcomes:
Locations:
city: Örebro
country: Sweden
facility: Psychiatric Research Centre
Study officials:
affiliation: School of Health and Medical Science, Psychiatric Research Centre
name: Fredrik Holländare, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hollandare F, Eriksson A, Lovgren L, Humble MB, Boersma K. Internet-Based Cognitive Behavioral Therapy for Residual Symptoms in Bipolar Disorder Type II: A Single-Subject Design Pilot Study. JMIR Res Protoc. 2015 Apr 23;4(2):e44. doi: 10.2196/resprot.3910.
Clinical trial NCT05131451: ACCESS: AI for pediatriC diabetiC Eye examS Study
Official title: Autonomous AI for Diabetic Retinopathy Screening in Youth (AI-DR): A Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 1 Diabetes
Type 2 Diabetes
Keywords: Diabetic Retinopathy
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: National Eye Institute (NEI)
First posted: 2021-11-23
Enrollment: 164
Sex: ALL
Minimum age (years): 8
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 1. Control Arm - Standard of care referral to an eye care provider + Educational Reinforcement
2. Intervention Arm - Point of Care Diabetic Retinopathy screening using Autonomous artificial intelligence on a non-mydriatic fundus camera
Primary purpose: SCREENING

Brief summary: The purpose of this study is to determine if providing in clinic point-of-care autonomous AI diabetic retinopathy exams improves screening rates compared to standard of care referral to an eye care provider, in a randomized control trial in a racially and ethnically diverse cohort of youth.

Detailed description: This study will recruit 164 individuals ages 8-21 with type 1 and type 2 diabetes. Participants will be randomized to usual care (referral to an eye care provider for a dilated eye exam) or the intervention arm and undergo a point-of-care diabetic eye exam using autonomous AI software on a non-mydriatic fundus camera. Participants in the intervention group will receive the diabetic eye exam results immediately from the autonomous AI system, and if abnormal will be referred to an eye care provider for a dilated eye exam. Participants in the standard of care group will have 6 months to complete the diabetic eye exam.

Eligibility criteria: Inclusion Criteria:

Meets American Diabetes Association (ADA) criteria for diabetic retinopathy screening:

* Diagnosis of Type 1 diabetes for ≥3 years, and age 11 or in puberty
* Diagnosis of Type 2 diabetes

Exclusion Criteria:

* Diabetic eye exam within the last 6 months
* Known diabetic retinopathy

Primary outcomes:
measure: Number of Participants Who Get Screened With a Diabetic Eye Exam
timeFrame: 6 months
Secondary outcomes:
measure: Follow-up Rates With an Eye Care Provider
timeFrame: 6 months
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins Pediatric Diabetes Center
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Risa Wolf, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00931151: Effects of Dietary Protein on Undesirable Postprandial Events in Overweight Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Overweight
Lead sponsor: Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement
Sponsor class: OTHER
Collaborators: name: National Research Agency, France
First posted: 2009-07-02
Enrollment: 10
Sex: MALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: Dietary protein differing by their amino acid composition could modulate undesirable metabolic and functional responses to a meal rich in saturated fat and sugars. This study aims at examining the specific effects of dairy protein with different cysteine contents on the postprandial undesirables effects elicited by the ingestion of a high fat meal in overweight subjects.


Eligibility criteria: Inclusion Criteria:

* BMI between 25 and 30
* Waist circumference \> 94 cm

Exclusion Criteria:

* Allergy to milk protein
* Abusive drug consumption
* Smoking
* Hypertension, diabetes
* High level of physical activity

Primary outcomes:
measure: Endothelial dysfunction
timeFrame: 0-2-4-6 hours (after meal ingestion)
Secondary outcomes:
measure: Postprandial inflammation
timeFrame: 0-0.5-1-1.5-2-3-4-6 hours (after meal ingestion)
Other outcomes:
Locations:
city: Bobigny
country: France
facility: Centre de recherche sur volontaires
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Robert Benamouzig, MD, Ph. D
role: PRINCIPAL_INVESTIGATOR
References:
citation: Pujos-Guillot E, Brandolini-Bunlon M, Fouillet H, Joly C, Martin JF, Huneau JF, Dardevet D, Mariotti F. Metabolomics Reveals that the Type of Protein in a High-Fat Meal Modulates Postprandial Mitochondrial Overload and Incomplete Substrate Oxidation in Healthy Overweight Men. J Nutr. 2018 Jun 1;148(6):876-884. doi: 10.1093/jn/nxy049.
citation: Mariotti F, Valette M, Lopez C, Fouillet H, Famelart MH, Mathe V, Airinei G, Benamouzig R, Gaudichon C, Tome D, Tsikas D, Huneau JF. Casein Compared with Whey Proteins Affects the Organization of Dietary Fat during Digestion and Attenuates the Postprandial Triglyceride Response to a Mixed High-Fat Meal in Healthy, Overweight Men. J Nutr. 2015 Dec;145(12):2657-64. doi: 10.3945/jn.115.216812. Epub 2015 Oct 21.
Clinical trial NCT05709951: Effects of Functional Versus Core Stability Exercises on Pain and Sleep Quality in Patients With Primary Dysmenorrhea
Official title: Effects of Functional Versus Core Stability Exercises on Pain and Sleep Quality in Patients With Primary Dysmenorrhea
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Primary Dysmenorrhea
Keywords: Core stability,Exercises,Primary dysmenorrhea,sleep quality
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2023-02-02
Enrollment: 24
Sex: FEMALE
Minimum age (years): 15
Maximum age (years): 30
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To compare the effects of Functional and Core stability exercises on pain and sleep quality in Patients with Primary Dysmenorrhea and to check the results of exercises may be effective in pain during Menstrual and before cramping in menses.


Eligibility criteria: Inclusion Criteria:

* Having used medication for menstrual pain and not having used oral contraceptives during the three months prior to admission to the study.
* Pain must be periodic (at least following 3 menstrual cycles).
* Lower abdominal cramps pain ends after periods and gradually diminish over 12 to 72 hrs.
* No history of blood disorders including thalassemia and folate or iron-deficiency anemia

Exclusion Criteria:

* Pelvic inflammatory disease
* Ovarian cysts
* Chronic abdominal pain
* Fibroids, obstructive endometrial polyps,
* Irritable bowel syndrome
* Major abdominal or pelvic surgery
* Intrauterine devices.

Primary outcomes:
measure: Visual analogue scale for lower abdominal pain
timeFrame: 8 week
measure: Menstrual Symptom Questionnaire
timeFrame: 8 weeks
measure: Pittsburgh Sleep Quality Index
timeFrame: 8 week
Secondary outcomes:
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: Jinnah Hospital
state: Punjab
Study officials:
affiliation: Riphah International University
name: Fatima Tariq, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01266551: Car Safety Seat and Gastroesophageal Reflux Disease
Official title: The Car Safety Seat; Cause of Increased Gastroesophageal Reflux Disease in Infants?
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Gastroesophageal Reflux Disease and Position
Keywords: Antireflux procedure
Gastroesophageal reflux
Infant sleep position
pH monitoring
Lead sponsor: University Hospital, Antwerp
Sponsor class: OTHER
First posted: 2010-12-24
Sex: ALL
Minimum age (years): 2
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: What's known? Prone position is no longer a treatment option for GERD because of the association with SIDS. Originally, positioning in an infant seat was recommended for infants with GERD. However, Orenstein proved this position has a detrimental effect on GER, compared to prone positioning.

What's new? Positioning in an infant seat caused no increase in GER, compared with the supine 15 degrees anti-Trendelenburg position. Except for the number of long reflux episodes, which was significantly higher in the car safety seat. Larger trials are needed for decisive conclusions.

Detailed description: OBJECTIVE - Over the past few decades, an increase in gastroesophageal reflux disease (GERD) has been seen in infants. This increase may be due to a continuous growth in the use of car safety seats. The objective of this study was to evaluate this hypothesis by comparing positioning in a car safety seat with the supine 15 degrees anti-Trendelenburg position.

PATIENTS AND METHODS - From October 2008 till August 2010 a crossover, randomized, controlled trial was performed on 31 infants, aged two weeks to six months old, who were suspected to have GERD. Twenty hour continuous esophageal pH monitoring was used to compare both positions.

RESULTS - The results of this trial demonstrated no differences between positioning in a car safety seat and in supine 15 degrees anti-Trendelenburg position for the reflux index, the duration of the longest reflux episode and number of reflux episodes (PRI = NS; PLRE = NS respectively PNRE = NS). Only the difference between the number of reflux episodes lasting longer than five minutes was significant (PNRE5 = 0,05).

CONCLUSIONS - The results of this study suggest that an increase in GERD is not caused by a growing use of car safety seats in infants. As the sample size was limited, larger trials are needed.

Eligibility criteria: Inclusion Criteria:

* Inclusion criteria were: healthy term-born infants between two weeks and six months old suspected to have GERD, in general good health. The infants did not need to meet the criteria for GERD to be eligible.

Exclusion Criteria:

* Exclusion criteria were infants with psychomotor retardation, acute illness or contra-indication for pH monitoring.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Antwerp
country: Belgium
facility: Antwerp University Hospital
Study officials:
References:
Clinical trial NCT01317251: Effect of Milk and Cheese on Fecal Fat Excretion and Blood Lipid
Official title: Effect of Milk and Cheese on Fecal Fat Excretion and Blood Lipid
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Keywords: Obesity prevention
appetite regulation
hyperlipidemia
Lead sponsor: University of Copenhagen
Sponsor class: OTHER
First posted: 2011-03-17
Enrollment: 15
Sex: MALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: The aim is to study the effect of milk versus cheese on fecal fat excretion and blood lipids. To do this, a randomized crossover intervention study with 3 14-day periods (control diet, milk diet, cheese diet) will be conducted in 16 young males. Fasting blood samples will be collected before and after each period, and fecal samples will be collected for the last 5 days in each period.


Eligibility criteria: Inclusion Criteria:

* Healthy males
* BMI 20-28 mg/m2

Exclusion Criteria:

* Smoking
* Medicine use
* Dietary supplements
* Lactose intolerance, milk allergy
* Dislike of dairy products
* Excessive physical activity (\> 10h/wk)
* Known chronic illnesses

Primary outcomes:
measure: Fecal fat excretion
timeFrame: During day 10-14 in each period
Secondary outcomes:
measure: Total, HDL and LDL cholesterol
timeFrame: Day 1 and 14 in each period
measure: Triglycerides
timeFrame: Day 1 and 14 in each period
measure: Appetite sensation
timeFrame: Assessed on day 1, 8 and 14 in each period
Other outcomes:
Locations:
city: Frederiksberg C
country: Denmark
facility: Department of Human Nutrition, University of Copenhagen
Study officials:
affiliation: University of Copenhagen
name: Arne Astrup, Dr med
role: PRINCIPAL_INVESTIGATOR
References:
citation: Soerensen KV, Thorning TK, Astrup A, Kristensen M, Lorenzen JK. Effect of dairy calcium from cheese and milk on fecal fat excretion, blood lipids, and appetite in young men. Am J Clin Nutr. 2014 May;99(5):984-91. doi: 10.3945/ajcn.113.077735. Epub 2014 Mar 12.