louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00719225: A Belatacept Compassionate Use Study for Patients With a Kidney Transplant
Official title: Belatacept for Renal Allograft Recipients: A Compassionate Use Program
Study type: EXPANDED_ACCESS
Overall status: NO_LONGER_AVAILABLE
Conditions: Renal Transplantation
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2008-07-21
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT

Brief summary: To make belatacept available for recipients of a renal allograft who are currently intolerant to or have contraindications to CNIs and/or m-TOR inhibitors and are either:

* unable to construct an adequate immunosuppression regimen due to nonrenal toxicity / contraindication (and withdrawing the causative agent would lead to renal graft loss) OR
* at imminent risk of losing the allograft kidney due to nephrotoxicity and have no other options for renal replacement therapy


Eligibility criteria: Please call 800-398-9157 for information on this study

Inclusion Criteria:

* Men and women of age 18 years or older inclusive
* Recipient of a renal allograft for at least ≥ 2 months
* EBV positive
* Unable to tolerate a suitable immunosuppression regimen to prevent acute allograft rejection, due to:
* Extra-renal toxicity related to CNIs and/or m-TOR inhibitors that is refractory to medical management (eg, uncontrolled seizures)
* Contraindication to CNIs and/or m-TOR inhibitors

OR

* At imminent risk of losing allograft kidney due to nephrotoxicity
* Renal failure: ≥ Stage 4 on KDOQI Scale (GFR 15 - 29 cc/min)
* And no other renal replacement therapy
* Subjects must be receiving the maintenance immunosuppressants MMF, MPA, or AZA

Exclusion Criteria:

* Any significant infection, extra-renal solid organ (heart, liver, pancreas) or cell (islet, bone marrow, stem cell) transplants, with an unresolved episode of AR within the last 6 weeks
* EBV negative

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: La Jolla
country: United States
facility: Scripps Green Hospital
state: California
city: Atlanta
country: United States
facility: Office Of Dr. Allan Kirk
state: Georgia
city: New Iberia
country: United States
facility: Acadiana Renal Physicians
state: Louisiana
city: New Orleans
country: United States
facility: Tulane Abdominal Transplant Institute
state: Louisiana
city: Chapel Hill
country: United States
facility: UNC Kidney Center
state: North Carolina
city: Allentown
country: United States
facility: The Transplant Center Of The Lehigh Valley
state: Pennsylvania
city: San Antonio
country: United States
facility: Texas Transplant Physician'S Group
state: Texas
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References:
Clinical trial NCT01484730: A Pilot Study to Evaluate Multi-Spectral and Laser Speckle Imaging and Multiphoton Microscopy During Vascular Occlusion
Official title: A Pilot Study to Evaluate Multi-Spectral Imaging (MI) and Laser Speckle Imaging (LSI) and Multiphoton Microscopy (MPM) During Vascular Occlusion
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Abnormal Vascular Flow
Lead sponsor: University of California, Irvine
Sponsor class: OTHER
Collaborators: name: United States Department of Defense
First posted: 2011-12-02
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Study population will be selected from University of California Irvine, student and staff member.

Brief summary: The purpose of this research is to evaluate and validate the performance of non-invasive imaging modalities for assessment of skin. A pressure cuff occlusion will be used to stimulate blood flow dynamic that these instruments are designed to sense. The researcher currently plan to assess only basic feasibility of the imaging instruments.

Detailed description: The primary reason for including pressure cuff occlusion in this protocol is to test the performance of Multi-Spectral Imaging and Laser Speckle Imaging can measure in the full range of vascular conditions ranging from ischemic (under-perfused or unsaturated) to hyperemic (over-perfused and over-saturated).

1. Modulated Imaging a non-contact optical imaging technology can detect the concentration of total hemoglobin, deoxygenated and oxygenated hemoglobin in absolute amounts in units of millimoles / unit volume of tissue measured.
2. Laser Speckle Imaging a non-contact optical imaging technology consists of a coherent light source, camera, and image acquisition system. This image device can measure and compare relative flow in vasculature at varied time points.

Eligibility criteria: Inclusion Criteria:

* Male and female adult 18 years and older

Exclusion Criteria:

* Younger than 18 years of age
* Pregnant women

Primary outcomes:
measure: Skin blood flow
timeFrame: 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Irvine
country: United States
facility: Beckman Laser Institute and Medical Clinic
state: California
Study officials:
affiliation: University of California, Irvine
name: Anthony Durkin, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03707730: A Randomized, Double-Blind, Placebo Controlled, Crossover Trial to Evaluate Safety and Efficacy of AGY in Celiac Disease
Official title: A Randomized, Double-Blind, Placebo Controlled, Crossover Trial to Evaluate Safety and Efficacy of AGY in Persons With Celiac Disease Age > 10 Years
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Celiac Disease
Lead sponsor: Igy Inc.
Sponsor class: INDUSTRY
Collaborators: name: Vetanda Group Ltd
First posted: 2018-10-16
Enrollment: 161
Sex: ALL
Minimum age (years): 10
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: randomized double-blind, placebo-controlled crossover trial
Primary purpose: TREATMENT

Brief summary: To assess the efficacy and safety of AGY vs placebo when administered to individuals age 10 to 65 years with medically proven CD and on a gluten free diet

Detailed description: We propose to conduct a randomized double-blind, placebo-controlled crossover trial in 149 individuals with celiac disease proven by biopsy (or other medically documented confirmation of CD, e.g. TTG counts \> 10 times the upper limit of normal on two occasions) at least 12 months before study entry, and who are following a gluten-free diet but continue to have recurrent symptoms.

AGY is designed to neutralize the hidden gliadin in food, thus preventing gliadin absorption and gliadin induced pathogenesis. The study will test whether AGY is safe and effective in the study population, versus placebo.

Primary Objective: The primary objective will be to evaluate the effect of AGY on celiac symptoms using the daily Celiac Symptom Index (CSI).

Secondary objectives: Secondary objectives will be to evaluate product safety and the effect of AGY on quality of life, autoantibodies, and gut permeability.

Eligibility criteria: Inclusion Criteria:

* history of CD
* experience periodic celiac related symptoms
* following a gluten free diet for at least 12 months

Exclusion Criteria:

* severe complications of CD or chronic active GI disease
* type 1 diabetic
* pregnant or breast feeding
* daily ASA/NSAID use
* any condition that in the opinion of the investigator, would preclude safe participation

Primary outcomes:
measure: symptoms
timeFrame: 14 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Edmonton
country: Canada
facility: University of Alberta
state: Alberta
city: Winnipeg
country: Canada
facility: St Boniface Hospital
state: Manitoba
Study officials:
affiliation: University of Alberta
name: Justine Turner, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02371330: The Neonatal Hemorrhagic Risk Assessment in Thrombocytopenia Study
Official title: The Neonatal Hemorrhagic Risk Assessment in Thrombocytopenia Study - Neo-HAT Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Thrombocytopenia
Keywords: Thrombocytopenia
Neonate
PFA-100
Neo-BAT
Hemorrhage
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
Collaborators: name: Thrasher Research Fund
First posted: 2015-02-25
Enrollment: 76
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients admitted to the Neonatal Intensive Care Unit who are \<32 weeks gestation or with a birth weight \<1500 grams.

Brief summary: This is a prospective longitudinal study that evaluates Platelet Function Analyzer-100 (PFA-100) CT-ADPs (closure time-ADP) and incidence of bleeding using the Neonatal Bleeding Assessment Tool - Neo-BAT in preterm neonates \<32 weeks gestational age or with a birth weight \<1500 grams and with different degrees of thrombocytopenia.

The investigators hypothesized that PFA-100 CT-ADP, a global in vitro test of primary hemostasis, will be a better predictor of clinical bleeding in neonates than platelet count alone. A bleeding risk assessment marker could help physicians more accurately determine the risk/benefit ratio of platelet transfusions, guiding platelet transfusion decisions in neonates with thrombocytopenia.


Eligibility criteria: Inclusion Criteria:

* \<32 weeks gestation or with a birth weight \<1500 grams;
* Have confirmed moderate-to-severe thrombocytopenia, defined as a platelet count \<100x109/L;
* Have a parent/guardian willing to comply with the protocol and provide written informed consent.

Exclusion Criteria:

* Are not expected to survive by the Attending Neonatologist;
* Are thought to have a congenital thrombocytopenia or platelet dysfunction, based on family history or clinical presentation (e.g. associated congenital malformations, platelet morphology);
* Have a major chromosomal anomaly such as Trisomy 13, 18, or 21.

Primary outcomes:
measure: Neo-BAT score (Neo-BAT: Neonatal Bleeding Assessment Tool)
timeFrame: study period: 5 days
Secondary outcomes:
measure: Number of thrombotic events
timeFrame: up to post-conceptional age 36 weeks
Other outcomes:
Locations:
city: Charlotte
country: United States
facility: Department of Pediatrics, Levine Children's Hospital, Carolinas Healthcare System
state: North Carolina
city: Stockholm
country: Sweden
facility: Astrid Lindgren Children's Hospital, Karolinska University Hospital
Study officials:
affiliation: Department of Women's and Children's Health, Karolinska Institutet
name: Emoke Deschmann, M.D., M.M.Sc.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Deschmann E, Sola-Visner M, Saxonhouse MA. Primary hemostasis in neonates with thrombocytopenia. J Pediatr. 2014 Jan;164(1):167-72. doi: 10.1016/j.jpeds.2013.08.037. Epub 2013 Oct 3.
Clinical trial NCT02948530: Measurement of Lung Elastance and Transpulmonary Pressure Using Two Different Methods (Lungbarometry)
Official title: Measurement of Lung Elastance and Transpulmonary Pressure Using Two Different Methods (Lungbarometry)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Acute Lung Injury
Lead sponsor: Sahlgrenska University Hospital
Sponsor class: OTHER
First posted: 2016-10-28
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CROSSOVER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Sedated and mechanically ventilated patients in the intensive care unit

Brief summary: Classically lung elastance and transpulmonary pressure are measured from the difference in tidal variations of airway pressure subtracted by tidal variations i esophagus pressure divided by the tidal volume. This requires the presence of a esophageal balloon catheter which is cumbersome and costly. In this study values obtained as described above are compared to values obtained with a new method in which a stepwise increase in positive endexpiratory pressure (PEEP) is performed with a size of the lung volume increase which corresponds to the tidal volume which the patient is ventilated with. The measurements are performed in sedated and mechanically ventilated patients in the intensive care unit.

Detailed description: Classically lung elastance and transpulmonary pressure are measured from the difference in tidal variations of airway pressure subtracted by tidal variations in esophageal pressure divided by the tidal volume (Method 1). This requires the presence of a esophageal balloon catheter which is cumbersome and costly.

In this study values obtained as described in Method 1 above are compared to values obtained with a new method (Method 2) in which a PEEP-step is performed with a size of the lung volume increase which corresponds to the tidal volume which the patient is ventilated with. Measurements using Method 1 and 2 are performed in sedated and mechanically ventilated patients in the intensive care unit.

Eligibility criteria: Inclusion Criteria:

Mechanically ventilated patients in the intensive care unit

Exclusion Criteria:

Patients with chronic obstrucive lung disease

Primary outcomes:
measure: Measurement of lung elastance and transpulmonary pressure
timeFrame: Within one hour
Secondary outcomes:
Other outcomes:
Locations:
city: Gothenburg
country: Sweden
facility: Sahlgrenska University Hospital
Study officials:
affiliation: Sahlgrenska University Hospital
name: Stefan Lundin, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00825630: 13-C Urea Breath Test Using BreathID System and PPIs (Proton Pump Inhibitors)
Official title: The Effect of High Dose Citric on PPI (Proton Pump Inhibitors)Induced False Negative H. Pylori UBT Rates
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Helicobacter Pylori Infection
Keywords: HP
UBT
PPI
Lead sponsor: Meridian Bioscience, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Rabin Medical Center
First posted: 2009-01-21
Enrollment: 123
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: Approximately 200 patients with suspected H.pylori will be tested with a 13C-Urea Breath Test (UBT) to ascertain H.pylori positive. 100 H.Pylori positive patients will tested before and after prescribed with one of the four selected Proton Pump Inhibitors (PPIs); 25 patients in each arm. This will provide information on the influence of PPIs on the UBT (Urea Breath Test). The aim of the trial is to observe the effect of different PPIs on the breath test and choose the optimal protocol of when to stop PPI. The hypothesis is that there will be a minimal effect on the UBT while using selected PPIs.

Detailed description: Adult subjects with suspected H pylori infection will be recruited and will undergo a 13C -Urea breath test (including citrica) with the BreathID test device. Those were found positive will undergo selected PPI treatment for 14 days and after 24 or 72 hours from the completion of the two weeks, will undergo a second breath test. Those found to be negative (false negative), will undergo additional breath tests.

* Those subjects that underwent any antibiotic, bismuth or PPI therapy 4 weeks prior to the trial, are to be excluded.
* Furthermore, pregnant or nursing women and subjects with an allergy or sensitivity to one of the tests substrates, will be excluded from the study.

Eligibility criteria: Inclusion Criteria:

* Adults with H.pylori infection.

Exclusion Criteria:

* Pregnancy,
* Nursing,
* Antibiotic, bismuth or PPI treatment 2 weeks prior to trial,
* Known sensitivity to Urea or citrica.

Primary outcomes:
measure: Urea Breath Test Result (DOB > 5 is Positive)After Different Time Periods From When PPI (Proton Pump Inhibitor) Was Stopped.
timeFrame: 17 days
Secondary outcomes:
Other outcomes:
Locations:
city: Petah Tikva
country: Israel
facility: Rabin Medical Center
Study officials:
affiliation: Sharon Hospital
name: Haim Shirin, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Shirin H, Frenkel D, Shevah O, Levine A, Bruck R, Moss SF, Niv Y, Avni Y. Effect of proton pump inhibitors on the continuous real time (13)C-urea breath test. Am J Gastroenterol. 2003 Jan;98(1):46-50. doi: 10.1111/j.1572-0241.2003.07187.x.
Clinical trial NCT00065130: Safety and Efficacy of Insulin Aspart vs. Regular Human Insulin in Gestational Diabetes
Official title: Safety and Efficacy of Insulin Aspart vs. Regular Human Insulin in Basal/Bolus Therapy for Patients With Gestational Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Diabetes
Gestational Diabetes
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2003-07-18
Enrollment: 27
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This trial is conducted in the United States of America (USA). The purpose of this study is to test whether NovoLog (insulin aspart) is a safe and at least as effective alternative to regular human insulin for the control of blood glucose after meals in women who develop diabetes during pregnancy.


Eligibility criteria: Inclusion Criteria:

* Subjects older than 35 years old will be considered
* Gestational diabetes mellitus

Primary outcomes:
measure: Postprandial glycemic control
Secondary outcomes:
measure: HbA1c (glycosylated haemoglobin A1c)
measure: Postprandial endogenous insulin secretory response
measure: Hypoglycemic episodes
measure: Adverse events
Other outcomes:
Locations:
city: Santa Barbara
country: United States
facility: Novo Nordisk Investigational Site
state: California
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References:
citation: Pettitt DJ, Ospina P, Kolaczynski JW, Jovanovic L. Comparison of an insulin analog, insulin aspart, and regular human insulin with no insulin in gestational diabetes mellitus. Diabetes Care. 2003 Jan;26(1):183-6. doi: 10.2337/diacare.26.1.183.
citation: Pettitt DJ, Ospina P, Howard C, Zisser H, Jovanovic L. Efficacy, safety and lack of immunogenicity of insulin aspart compared with regular human insulin for women with gestational diabetes mellitus. Diabet Med. 2007 Oct;24(10):1129-35. doi: 10.1111/j.1464-5491.2007.02247.x.
Clinical trial NCT00408330: A Study of Azelaic Acid (AzA) 15% Gel in the Treatment of Seborrheic Dermatitis of the Face
Official title: A Double-Blind, Randomized, Vehicle-Controlled, Six-Week Exploratory Multicenter Pilot Study of the Efficacy and Safety of Azelaic Acid (AzA) 15% Gel in the Topical Treatment of Mild to Moderate Seborrheic Dermatitis of the Face
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Seborrheic Dermatitis on the Face
Lead sponsor: LEO Pharma
Sponsor class: INDUSTRY
Collaborators: name: Bayer
First posted: 2006-12-06
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is to determine whether a medication on the market for other indications is effective and safe in treating seborrheic dermatitis of the face.

Detailed description: To test the efficacy and safety of azelaic acid 15% gel in the treatment of seborrheic dermatitis of the face

Eligibility criteria: Inclusion Criteria:

- Stable or exacerbating seborrheic dermatitis in the facial area

Exclusion Criteria:

* Psoriasis
* Atopic dermatitis
* Facial acne and rosacea
* Dermatophytic skin infections
* Parkinson's disease
* Known immunosuppression; HIV infection
* Any condition requiring continuous systemic or topical corticosteroid or antimycotic therapy
* Continuous asthma inhalation treatment requiring \> 800 mg corticosteroids
* Any severe disease likely to interfere with the conduct or the planned termination of the study

Primary outcomes:
measure: Sum Score of the symptoms of seborrheic dermatitis and the investigator's global assessment.
timeFrame: Measurement of parameters during the course of treatment (six weeks)
Secondary outcomes:
measure: Investigators' and patients' subjective assessment of improvement; frequency and intensity of single symptoms
timeFrame: Measurement of parameters during the course of treatment (six weeks)
Other outcomes:
Locations:
city: Blankenfelde-Mahlow
country: Germany
city: Buchholz
country: Germany
city: Hamburg
country: Germany
city: Hamburg
country: Germany
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT01078025: Evaluation of Microbial Colonisation and Contamination Caused by the Transvaginal and Transabdominal Access for Cholecystectomy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cholecystectomy
Keywords: transvaginal access for cholecystectomy
Lead sponsor: Cantonal Hospital of St. Gallen
Sponsor class: OTHER
First posted: 2010-03-02
Enrollment: 30
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Female patients with symptomatic cholecystolithiasis and given informed consent for laparoscopic cholecystectomy or transvaginal hybrid cholecystectomy

Brief summary: Transvaginal hybrid procedures are of interest as an available NOTES procedure for the clinical routine. The gynaecologists' experiences and the available studies report on low morbidity related to the transvaginal access. However, little is known about the vaginal and intraabdominal microbial contamination due to the transvaginal approach.

The aim of this cohort study is to evaluate the microbial colonisation and contamination in patients with transvaginal hybrid and conventional laparoscopic cholecystectomy.

Therefore, pre- and intraoperative microbiological evaluations will be performed in patients with transvaginal hybrid cholecystectomy and laparoscopic cholecystectomy.


Eligibility criteria: Inclusion Criteria:

* indication for elective cholecystectomy
* informed consent for laparoscopic cholecystectomy or transvaginal hybrid cholecystectomy

Exclusion Criteria:

* cholecystitis
* intraabdominal infection
* existing antibiotic therapy
* adnexitis
* pelvic inflammatory disease
* infection (CRP \> 10 mg /l; Lc \> 11 G/l)

Primary outcomes:
measure: Microbial colonisation and contamination vaginally and intraabdominally
timeFrame: 1 day
Secondary outcomes:
measure: Morbidity (wound, vaginal and intraabdominal infection) two weeks and six weeks postoperatively
timeFrame: 6 weeks
Other outcomes:
Locations:
city: St.Gallen
country: Switzerland
facility: Department of Surgery
Study officials:
affiliation: Cantonal Hospital St. Gallen
name: Andreas Zerz, MD
role: PRINCIPAL_INVESTIGATOR
References: