louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01212835: Effect of RING on Gastroesophageal Reflux (GERD) After RYGBP
Official title: The Use of a Silastic Ring in Open Gastric Bypass for Morbid Obesity and Its Association With Gastroesophageal Reflux Disease
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Morbid Obesity
Gastroesophageal Reflux Disease
Vomiting
Keywords: Obesity
gastroesophageal reflux disease
Morbid obesity
esophagitis
GERD
silastic ring
Gastric bypass
Lead sponsor: Clinica Gastrobese
Sponsor class: OTHER
First posted: 2010-10-01
Enrollment: 114
Sex: ALL
Minimum age (years): 18
Maximum age (years): 58
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Silastic rings have been used around the gastric pouch in order to promote better weight loss after Roux-and-Y gastric bypass surgery ( RYGBP). However the investigators have shown that some patients developed gastroesophageal reflux disease after RYGBP in a previous study. The investigators hypothesized that the use of a silastic ring may play a role in promoting GERD after this operation.

Detailed description: This is a randomized controlled double blind trial designed to identify if the use of the ring induces food intolerance and vomiting which may lead a esophageal mucosal erosions and/or GERD symptoms.

Eligibility criteria: Inclusion Criteria:

* Indications for bariatric surgery (BMI over 40Kg/m2 or over 35Kg/m2 associated to a life-treating morbid conditions.
* Acceptance to be submitted to a 24h pH-monitoring and esophageal manometry
* No contra-indication for gastric bypass
* Absence of previous gastric surgery
* Option for open gastric bypass

Exclusion Criteria:

* Inferior and superior total teeth prosthesis
* Poor surgical conditions

Primary outcomes:
measure: Occurence of gastroesophageal reflux disease
timeFrame: march 2010 to march 2014
Secondary outcomes:
measure: The role of the ring in open GBP in terms of weight loss
timeFrame: march 2010 to march 2014
measure: The impact of the ring on food tolerance
timeFrame: March 2010 to March 2014
Other outcomes:
Locations:
city: Passo Fundo
country: Brazil
facility: Clínica Gastrobese
state: RS
city: Passo Fundo
country: Brazil
facility: Gastrobese Clinic
state: RS
city: Passo Fundo
country: Brazil
facility: Hospital Sao Vicente de Paulo
state: RS
Study officials:
affiliation: Clinica Gastrobese
name: Daniel Navarini, M.D.
role: STUDY_CHAIR
affiliation: Clinica Gastrobese
name: Carlos AS Madalosso, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Clinica Gastrobese
name: Iran Moraes Jr, M.D.
role: STUDY_CHAIR
affiliation: Protocol control
name: Fabio R Barao, Admn
role: STUDY_DIRECTOR
References:
citation: Madalosso CA, Gurski RR, Callegari-Jacques SM, Navarini D, Thiesen V, Fornari F. The impact of gastric bypass on gastroesophageal reflux disease in patients with morbid obesity: a prospective study based on the Montreal Consensus. Ann Surg. 2010 Feb;251(2):244-8. doi: 10.1097/SLA.0b013e3181bdff20.
Clinical trial NCT02423135: Detection of Autologous DEHP (DiEthylHexyl Phthalate)-Free Blood Transfusion in Anti-doping
Official title: Detection of Autologous DEHP (DiEthylHexyl Phthalate)-Free Blood Transfusion Using a Combination of Multiple Biomarkers in Different Matrices.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Transfusion Reaction
Lead sponsor: Centre Hospitalier Universitaire Vaudois
Sponsor class: OTHER
First posted: 2015-04-22
Enrollment: 20
Sex: MALE
Minimum age (years): 20
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The aim of the proposed project is to perform a clinical study in which volunteers will receive autologous blood transfusions in DEHP-free blood bags.


Eligibility criteria: Inclusion Criteria:

* Have to fill the swiss blood donation formulary

Exclusion Criteria:

* Anemia
* Cardiovascular disease
* Neurologic disease
* Not performed a blood donation for 5 weeks ago the start of the study.
* Immunological disease

Primary outcomes:
measure: Measurement of blood parameters profile, iron metabolism and genomic compounds
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Epalinges
country: Switzerland
facility: Swiss Laboratory for Doping Analyses
state: Vaud
Study officials:
affiliation: Swiss Laboratory for Doping Analyses
name: Nicolas Leuenberger, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Leuenberger N, Barras L, Nicoli R, Robinson N, Baume N, Lion N, Barelli S, Tissot JD, Saugy M. Hepcidin as a new biomarker for detecting autologous blood transfusion. Am J Hematol. 2016 May;91(5):467-72. doi: 10.1002/ajh.24313. Epub 2016 Apr 6.
Clinical trial NCT06070935: Nailfold Capillaroscopic Assessment in Pediatric Uveitis Patients
Official title: Nailfold Capillaroscopic Assessment in Pediatric Uveitis Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Uveitis
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2023-10-06
Enrollment: 46
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: pediatric uveitis patients and healthy pediatric control

Brief summary: Pediatric uveitis accounts for 5-10% of uveitis cases. it may be infectious or noninfectious in etiology. The etiology of noninfectious uveitis may be autoimmune. The most common causes of pediatric uveitis are idiopathic and juvenile idiopathic arthritis-associated uveitis. Uveitis morbidities in pediatric patients include cataract, glaucoma, and amblyopia. Pediatric uveitis may be accopanied by involvement of the ocular vasculature, such as retinal vasculitis. We hypothesize that there are differences in systemic microcirculation between pediatric uveitis patients and healthy pediatric controls.

Detailed description: The systemic microcirculation will be investigated through nailfold capillaroscopic (NFC) assessment with noninfectious uveitis and healthy pediatric controls.

The NFC parameters are:

capillary density (number of capillaries per mm), dilated capillaries (apex of \>20µm), avascular areas, the presence of microhemorrhages, and capillary morphology (normal, multiple crossings, tortuous, bushy, ramified, non-convex, or bizarre capillaries).

Eligibility criteria: Inclusion Criteria:

* patients with uveitis \< 18 years old

Exclusion Criteria:

* infectious uveitis
* age \> 18 years old

Primary outcomes:
measure: capillary density by nailfold capillaroscopy
timeFrame: 6 months
measure: detection of number of dilated capillaries by nailfold capillaroscopy
timeFrame: 6 months
measure: detection of other abnormalities as avascular areas, microhemorrhages, and abnormal capillary morphology
timeFrame: 6 months
Secondary outcomes:
measure: correlation of nailfold findings with uveitis activity
timeFrame: 6 months
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Maha Abdelrahman
Study officials:
affiliation: Assiut University
name: Maha Abdelrahman, MD, PHD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05829135: Improving Glare and Visual Comfort for Patients With Visual Impairment
Official title: Managing Visual Comfort and Function in Patients With Low Vision Using Acuvue Oasys
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Photophobia
Visual Impairment
Low Vision
Lead sponsor: Nova Southeastern University
Sponsor class: OTHER
Collaborators: name: American Academy of Optometry
First posted: 2023-04-25
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To assess the use of contact lenses with transitions technology to improve glare, light sensitivity and overall visual comfort in patients with visual impairment.

Detailed description: Acuvue Oasys Contact Lenses with Transitions Light Intelligent Technology can adapt to the amount of visible light in the environment, darkening the lenses in bright sunlight, and returning to regular tint in normal or dim environment.

Purpose of this study is to assess whether individuals with visual impairment may benefit from these lenses to minimize glare, light sensitivity symptoms and improve the overall visual comfort.

Eligibility criteria: Inclusion Criteria:

* Ability to give informed consent
* Able to speak and read English
* Experience glare and light sensitivity that impacts patient's daily living activities
* Have confirmed diagnosis of ocular condition including but not limited to Stargardt's, Cone dystrophy, Cone-rod dystrophy, Albinism, Retinitis Pigmentosa and Achromatopsia.
* Willing and able to wear the contact lenses as instructed

Exclusion Criteria:

* Are pregnant, nursing or planning to become pregnant during the course of the study
* Have current/recent ocular infection, inflammation, surgery in the past 3 months that contraindicates contact lens wear

Primary outcomes:
measure: Glare test
timeFrame: Measure change from baseline at the 6 week follow-up visit
Secondary outcomes:
measure: Visual Activities Questionnaire on Glare and Light sensitivity visual functions
timeFrame: Measure change from baseline at the 6 week follow-up visit
Other outcomes:
Locations:
city: Davie
country: United States
facility: Nova Southeastern University
state: Florida
Study officials:
affiliation: Nova Southeastern University
name: So Yeon Lee, OD
role: STUDY_CHAIR
References:
Clinical trial NCT04721535: A Study of DWJ1248 in Prevention of COVID-19 Infection After the Exposure of SARS-COV-2
Official title: A Randomized Double-blinded Controlled Clinical Trial of DWJ1248 in Prevention of COVID-19 Infection After the Exposure of SARS-COV-2
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Covid19
SARS-COV-2 Infection
Lead sponsor: Daewoong Pharmaceutical Co. LTD.
Sponsor class: INDUSTRY
First posted: 2021-01-22
Enrollment: 9
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: To evaluate the prevention of SARS-COV-2 infection after administration of DWJ1248 in person who contact from COVID-19 confirmed patient compared to the placebo.


Eligibility criteria: Inclusion Criteria:

* Adults over the age of 19 as of the signed date in written consent
* Subjects in self-quarantine who contact from COVID-19 confirmed patient
* Subjects who have COVID-19 negative RT-PCR result
* Subjects with no symptoms of COVID-19

Exclusion Criteria:

* Subjects who cannot orally administer the investigational products
* Subjects who need administration of immunosuppressants
* Subjects who are allergic or sensitive to investigational products or its ingredients
* Subjects who have a history of drug and/or alcohol abuse within 12 months before screening
* Subjects who have been identified with uncontrolled concomitant diseases or conditions, including significant mental illness and social conditions, that may affect compliance with clinical trial procedures according to the determination of the investigators

Primary outcomes:
measure: Percentage of subjects with COVID-19
timeFrame: Up to 14 days
Secondary outcomes:
measure: Percentage of subjects with hospitalization
timeFrame: Days 3, 7, 14, and 28
measure: Percentage of subjects who experience intensive care unit (ICU)
timeFrame: Days 3, 7, 14, and 28
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
Study officials:
References:
Clinical trial NCT06008535: 10-year Results of Open Inguinal Hernia Repair
Official title: 10-year Results of Open Inguinal Hernia Repair. A Prospective Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Recurrence
Chronic Pain
Lead sponsor: Tartu University Hospital
Sponsor class: OTHER
First posted: 2023-08-23
Enrollment: 234
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study group consists of patients who were operated on with a primary inguinal hernia in the department of general surgery and plastic surgery between 2008-2013 at the Tartu University Hospital.

Brief summary: The main goal of the research is to evaluate the long-term results of open anterior alloplasty of inguinal hernia, mainly the occurrence of recurrences. The secondary aim of the study is to clarify the incidence of chronic pain and foreign body sensation 10 years after inguinal hernia surgery.

Patients who meet the criteria for inclusion in the study are invited to an appointment, where a questionnaire is filled out, an clinical examination and an ultrasound examination are performed.


Eligibility criteria: Inclusion Criteria:

* primary inguinal hernia operated between 2008-2013 at the Tartu University Hospital
* elective surgery
* age at least 18 years old at the time of the operation
* ability to understand the guidelines and willing to participate in the study

Exclusion Criteria:

* recurrent hernia
* strangulated hernia
* age under 18 years at the time of surgery
* does not agree to participate in the study
* does not understand the guidelines. Regarding the last exclusion criterion: since it is an assessment of the remote results of the treatment and probably relatively many of the subjects are very elderly, it may happen that when contacting the patient by phone it turns out that the patient is no longer adequate to make a decision about participating in the study or to answer questions (experienced cerebral infarction, dementia, etc. .) - in this case, the patient is not invited to the appointment.

Primary outcomes:
measure: Recurrence
timeFrame: at 10-year follow-up
Secondary outcomes:
measure: Chronic pain
timeFrame: at 10-year follow-up
Other outcomes:
Locations:
city: Tartu
country: Estonia
facility: Tartu University Hospital
state: Tartumaa
Study officials:
affiliation: Tartu University Hospital
name: Ceith Nikkolo, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02525835: Tissue Sodium in Autoimmune Disease
Official title: Tissue Sodium in Autoimmune Disease
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Systemic Lupus Erythematosus
Lead sponsor: Vanderbilt University Medical Center
Sponsor class: OTHER
First posted: 2015-08-17
Enrollment: 0
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: This pilot study will test the hypothesis that a low sodium diet will decrease sodium (23Na) magnetic resonance imaging-determined skin sodium concentrations in patients with systemic lupus erythematosus (SLE) and improve blood pressure and inflammation

Detailed description: This pilot study will test the hypothesis that a low sodium diet will decrease 23Na magnetic resonance imaging-determined skin sodium concentrations in patients with SLE and improve blood pressure and inflammation. Investigators plan to enroll 21 participants who will be randomized to low salt or high salt diet. Participants will eat the first diet for 28 days, and after a 2 week washout, Participants will eat the second diet (whichever the participant was not randomized to for the first phase). Participant will know what diet participant is on, study coordinator who does the assessment will be blinded to diet.

Eligibility criteria: Inclusion Criteria:

* male and female patients 18 and over
* meets 2012 International criteria for the diagnosis of SLE
* have stable disease activity as evidenced by no significant change in immunomodulating therapy in last month
* provide written informed consent

Exclusion Criteria:

* Pregnancy
* Receiving dialysis
* Organ or bone marrow transplant
* Uncontrolled hypertension, BP\> 160/100 mm Hg at screening
* Severe edema as judged by investigator
* Diabetes mellitus requiring drug therapy
* Major surgery within the previous 3 months
* Severe co-morbid conditions such as active cancer likely to compromise study participation
* unwillingness or other inability to cooperate
* Conditions that alter sodium homeostasis substantially including heart failure, clinically evident liver disease, clinically evident renal dysfunction (creatinine clearance \< 50 nl/min or \> 2+ proteinuria, or being treated for lupus nephritis

Primary outcomes:
measure: sodium concentration in skin
timeFrame: 3 months
Secondary outcomes:
measure: SLEDAI
timeFrame: 3 months
measure: blood pressure
timeFrame: 3 months
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Vanderbilt University
state: Tennessee
Study officials:
affiliation: Vanderbilt University
name: Charles M Stein, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01201135: GDF 15 in Sickle Cell Disease and Hereditary Spherocytosis
Official title: The Impact of Growth Differentiating Factor (GDF) 15 in Sickle Cell Disease and Hereditary Spherocytosis
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Patients With Thalassemia Intermedia,
Congenital Dyserythropoietic Anemia Type I
Lead sponsor: Wolfson Medical Center
Sponsor class: OTHER_GOV
First posted: 2010-09-14
Enrollment: 80
Sex: ALL
Minimum age (years): 5
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study will contain 40 patients with Sickle cell disease and 40 patients with hereditary spherocytosis.

After ICF (Informed Consent Form) has been signed by the patients the following laboratory tests will be taken once during the study:

1. GDF 15( 3ml of serum) (at the laboratory of hematology at Wolfson Medical Center/Israel)
2. Hepcidine (3ml of serum) (at the laboratory of Prof. T. Ganz, USA). The blood samples should be taken at least one week apart from blood transfusion.

In case of infection or acute inflammation , blood samples should be taken only one week after resolution of these conditions.

Brief summary: Patients with thalassemia intermedia, congenital dyserythropoietic anemia type I , and sideroblastic anemia were found to express very high levels of serum GDF15, and this contributed to the inappropriate suppression of hepcidin with subsequent secondary iron overload.The aim of our present study is to asses the levels of GDF15 and hepcidin in patients with Sickle cell disease and hereditary spherocytosis

Detailed description: The identification of the ferroportin/hepcidin axis has allowed the effect of erythroid activity on iron balance to be studied and has created the basis for better defining the erythroid regulators.

In iron-loading anemias, ineffective erythropoiesis suppresses hepcidin production, which result in dysregulating iron homeostasis. Miller and co-workers showed that release of cytokines like growth differentiation factor 15 (GDF15) during the process of ineffective erythropoiesis inhibits hepcidin production, thus defining a molecular link between ineffective erythropoiesis, suppression of hepcidin production and parenchymal iron loading.

Eligibility criteria: Inclusion Criteria:

* non

Exclusion Criteria:

* non

Primary outcomes:
measure: GDF 15
timeFrame: year
Secondary outcomes:
measure: Hepcidine
timeFrame: year
Other outcomes:
Locations:
Study officials:
affiliation: HEMATOLOGY DEPARTMENT ON WOLFSSON MEDICAL CENTER
name: GHOTI HOSSAM, doctor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03209635: Weissella Cibaria JW15 Consumption and NK Cell Activity
Official title: Weissella Cibaria JW15 Consumption and NK Cell Activity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Immune Function
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2017-07-06
Enrollment: 100
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

Brief summary: A The aim of this study was to investigate the impact of consuming Weissella cibaria (W. cibaria) JW15 supplementation isolated from Kimchi, Korea traditional fermented food, on natural killer (NK) cell activity and circulating levels of cytokines and immunoglobulin (Ig).

Detailed description: A randomized, double-blinded, placebo-controlled study was conducted on 100 nondiabetic subjects. Over an eight-week testing period, the probiotic group consumed 4 capsules (300 mg/capsule) containing 1 x 10\^10 colony-forming units (cfu) of W. cibaria JW15 each day, whereas the placebo group consumed the same product without a probiotic.

Eligibility criteria: Inclusion Criteria:

* Nondiabetic (fasting serum glucose concentration \< 126 mg/dL)
* Subjects with 4,000-8,000 leukocyte counts

Exclusion Criteria:

* Constant consumption of any probiotic products
* Taking medicine related to inflammation within one month before screening
* Allergy to probiotics
* Lactose intolerance
* Diabetes
* History/presence of significant metabolic disease
* Acute or chronic disease requiring treatment
* Taking any medications

Primary outcomes:
measure: Natural killer cell activity at baseline
timeFrame: Baseline
measure: Natural killer cell activity at 8-week follow up
timeFrame: 8-week follow up
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Dept. of Food and Nutrition, Colleage of Human Ecology, Yonsei University
name: Jong Ho Lee, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00038935: Study Evaluating BDDRFVIII and ReFacto AF in Hemophilia A
Official title: A Single Dose, Randomized, Double-Blind, 2-Period Crossover Study in Patients With Hemophilia A to Evaluate the Pharmacokinetics of B-Domain Deleted Recombinant Human Factor VIII (BDDrFVIII) Manufactured by the Current Process (ReFacto) and by an Albumin Free Manufacturing Process (ReFacto AF)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hemophilia A
Keywords: Hemophilia
Lead sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
Sponsor class: INDUSTRY
First posted: 2002-06-07
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine the relative bioavailability of ReFacto AF as compared to ReFacto, when each is administered as 2-minute bolus infusions.


Eligibility criteria: Inclusion Criteria:

* Severe hemophilia A (FVIII:C \< 1% at local laboratory)
* Previously treated patients (PTP) with at least 250 exposure days to any factor VIII product
* Age greater than or equal to 12 years\\

Exclusion Criteria:

* The presence of any bleeding disorder in addition to hemophilia A
* Concomitant therapy with immunosuppressant drugs (e.g., intravenous immunoglobulin (IVIG), routine systemic corticosteroid use)
* History of detectable factor VIII inhibitor

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Wyeth is now a wholly owned subsidiary of Pfizer
name: Medical Monitor, MD
role: STUDY_DIRECTOR
References:
citation: Korth-Bradley J, Rupon J, Plotka A, Charnigo R, Rendo P. Assessment of Relative Bioavailability of Moroctocog Alfa and Moroctocog Alfa (AF-CC) in Subjects With Severe Hemophilia A. Clin Transl Sci. 2018 May;11(3):283-288. doi: 10.1111/cts.12544. Epub 2018 Mar 25.