louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05205863: Dose-Response in PD and Safety of Cofact Under VKA Anticoagulation
Official title: A Phase 1/2 Study of the Dose-Response in Pharmacodynamics and Safety of Prothrombin Complex Concentrate Cofact in Healthy Subjects Under Vitamin K Antagonist Anticoagulation.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Healthy Volunteers
Lead sponsor: Prothya Biosolutions
Sponsor class: INDUSTRY
Collaborators: name: PRA Health Sciences
First posted: 2022-01-25
Enrollment: 69
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a randomized, open label, placebo-controlled, parallel design, single center, prospective study. Subjects will receive treatment with VKA. Subjects who reach the targeted INR, will receive single dose of Cofact. Multiple coagulation laboratory tests will be evaluated over a period of 15 days


Eligibility criteria: Inclusion Criteria:

* Male or female of nonchildbearing potential.
* Healthy subjects.

Exclusion Criteria:

* Evidence of coagulation disturbances, or disposition for thrombo-embolic events
* Liver function tests more than 1.2 times the upper normal limits
* Participants with thyroid disorders as evidenced by assessment of TSH levels outside the normal reference range at screening.
* Prior history of thromboembolic complications including those in first degree relatives.
* Glomerular filtration rate (GFR) is lower than estimated GFR 62 mL/min/1.73 m2 using the Modification of Diet in Renal Disease Study equation.
* Anaphylactic or systemic reactions to human plasma, plasma products, or blood products.
* History of hypersensitivity to active or inactive excipients of VKA
* Gastrointestinal disease that may impair VKA absorption..
* Participation in another clinical study \<30 days prior to study entry.
* Any clinically significant history of or current clinically significant disease or disorder as judged by the Investigator.
* Positive nasopharyngeal PCR test for SARS-CoV-2 on Day -11 or Day -1.
* Positive pregnancy test at screening, Day -11, or Day -1.

Primary outcomes:
measure: Peak thrombin generation at 30 minutes after end of the Cofact infusion
timeFrame: 30 minutes post Cofact infusion
Secondary outcomes:
measure: Changes in ETP
timeFrame: 24 hours post Cofact infusion
measure: Concentration in clotting factors
timeFrame: up to Day 15
measure: Coagulation markers
timeFrame: up to Day 15
measure: Coagulation activation markers
timeFrame: up to Day 15
measure: Safety outcome
timeFrame: up to Day 15
Other outcomes:
Locations:
city: Groningen
country: Netherlands
facility: PRA Health Sciences
Study officials:
affiliation: PRA Health Sciences
name: Salah Hadi, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Prothya Biosolutions
name: Thomas Bodewes, MD
role: STUDY_CHAIR
References:
Clinical trial NCT03835663: The Bacterial Composition of the Stomach in Reflux Disease
Official title: Identification of Bacteria Responsible for the the Development of Oesophago-gastric Cancer
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: GORD
Oesophageal Cancer
Oesophageal Reflux
Gastric Cancer
Gastro Esophageal Reflux
Oesophageal Carcinoma
Barrett Esophagus
Esophagitis
Lead sponsor: Imperial College London
Sponsor class: OTHER
First posted: 2019-02-08
Enrollment: 100
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: Patients with erosive, non-erosive reflux and patients with no symptoms of reflux and healthy upper GI mucosa.

Brief summary: Gastric and oesophageal (OG) cancer associated with poor long term outcome as overall less than 25% of patients survive for more than 5 years due to late recognition of the disease. Growing evidence suggests an important role for bacteria in OG cancer and gastro esophageal reflux disease (GORD) development. About 1 in 10 people suffer from GORD and this one of the most common conditions leading to gastric and oesophageal cancer.

In GORD surgical therapy is the most successful preventing cancer but around 85% of patient experience complications afterwards. Acid suppressing medications are reducing the risk of oesophageal cancer but equally increasing the risk of gastric cancer. They also shorten patients' life expectancy and often fail to provide relief. Analysis of stool samples of patients with GORD demonstrated different gut bacterial compositions to normal and rather resembled the one found in cancer.

There is a clear need to improve the outcome of OG cancer. This could be achieved by identifying bacteria responsible for cancer development in gastric tissue, gastric content and saliva and potentially eliminate them hence avoid the development of cancer.


Eligibility criteria: Inclusion Criteria:

* Patients who deemed necessary for an upper gastro intestinal endoscopy for clinical reasons and consent for additional gastric mucosal biopsies for study purposes

Exclusion Criteria:

* Patients who have upper GI malignancy

Primary outcomes:
measure: Difference in the bacterial composition of the gastric mucosa between the three groups
timeFrame: Samples are collected on the day of endoscopy following min 6 hours starvation and preserved on -80C
measure: Difference in the amount of bacteria of the gastric mucosa between the three previously described groups.
timeFrame: Samples are collected on the day of endoscopy following min 6 hours starvation and preserved on -80C
Secondary outcomes:
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Imperial College Healthcare, St Mary's Hospital, Paddington
Study officials:
References:
Clinical trial NCT00389363: Efficacy and Safety Trial of the ALK HDM Tablet in House Dust Mite Allergic Subjects
Official title: A Phase II-III Trial Assessing the Efficacy and Safety of Three Doses of the ALK HDM Tablet in House Dust Mite Allergic Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Asthma
Lead sponsor: ALK-Abelló A/S
Sponsor class: INDUSTRY
First posted: 2006-10-18
Enrollment: 800
Sex: ALL
Minimum age (years): 14
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of the trial is to determine if treatment of asthma patients allergic to house dust mites with the ALK HDM tablet can reduce the need of inhaled corticosteroids (ICS).


Eligibility criteria: Inclusion Criteria:

* A history of house dust mite induced asthma
* Use of inhaled corticosteroids (ICS)
* Positive skin prick test to house dust mites
* Positive specific IgE to house dust mites

Exclusion Criteria:

* FEV1 lower than 70%

Primary outcomes:
measure: Use of inhaled corticosteroid (ICS).
Secondary outcomes:
measure: Use of rescue medication and symptoms.
measure: Quality of Life.
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Rigshospitalet
Study officials:
affiliation: ALK-Abelló
name: Kim Simonsen, MD.
role: STUDY_DIRECTOR
References:
citation: Bernstein DI, Kleine-Tebbe J, Nelson HS, Bardelas JA Jr, Sussman GL, Lu S, Rehm D, Svanholm Fogh B, Nolte H. SQ house dust mite sublingual immunotherapy tablet subgroup efficacy and local application site reaction duration. Ann Allergy Asthma Immunol. 2018 Jul;121(1):105-110. doi: 10.1016/j.anai.2018.04.007. Epub 2018 Apr 12.
citation: Mosbech H, Canonica GW, Backer V, de Blay F, Klimek L, Broge L, Ljorring C. SQ house dust mite sublingually administered immunotherapy tablet (ALK) improves allergic rhinitis in patients with house dust mite allergic asthma and rhinitis symptoms. Ann Allergy Asthma Immunol. 2015 Feb;114(2):134-40. doi: 10.1016/j.anai.2014.11.015.
Clinical trial NCT00116363: Safety and Efficacy Study of INGN 241 Gene Therapy in Patients With In Transit Melanoma
Official title: Phase II Study Examining the Biological Efficacy of Intratumoral INGN 241 (Ad-mda7) Administration in Patients With In Transit Melanoma
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Malignant Melanoma
Neoplasm Metastasis
Keywords: gene therapy
melanoma
adenovirus
in-transit melanoma
metastatic melanoma
Lead sponsor: Introgen Therapeutics
Sponsor class: INDUSTRY
Collaborators: name: M.D. Anderson Cancer Center
First posted: 2005-06-29
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a research study to look at the ways in which a treatment called INGN241 can kill melanoma cells or help the patient's immune system kill melanoma cells.

Detailed description: INGN 241 is an adenoviral vector carrying the MDA-7 cDNA. MDA-7 is a novel tumor suppressor molecule with cytokine properties, recently designated as IL-24. Over expression of MDA-7 in melanoma cells in vitro has been shown to inhibit cellular proliferation and induce apoptosis. Loss of MDA-7 expression in human melanomas has been shown to correlate with invasion and metastasis. The INGN 241 gene transfer construct has been previously used in human subjects in an ongoing open label Phase I study using intratumoral administration, and has been well tolerated to date. The primary objectives of the present study are to determine if INGN 241, injected into a melanoma in transit lesion, can induce apoptosis in regional uninjected lesions and initiate systemic immune activation. Secondary objectives include examination of specific immunity and of clinical response and toxicity.

Eligibility criteria: Inclusion Criteria:

* Histologically proven melanoma, must have 3 regional metastatic lesions that are in transit

Exclusion Criteria:

* Central nervous system involvement by melanoma

Primary outcomes:
measure: anti-tumor effects and systemic immune activation at 28 days
Secondary outcomes:
measure: tumor response
measure: toxicity and safety
measure: the induction of antigen-specific T-lymphocytes after multiple cycles of treatment
Other outcomes:
Locations:
city: Houston
country: United States
facility: University of Texas MD Anderson Cancer Center
state: Texas
Study officials:
affiliation: UT MD Anderson Cancer Center
name: Kevin B Kim, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Casciello F, Kelly GM, Ramarao-Milne P, Kamal N, Stewart TA, Mukhopadhyay P, Kazakoff SH, Miranda M, Kim D, Davis FM, Hayward NK, Vertino PM, Waddell N, Gannon F, Lee JS. Combined Inhibition of G9a and EZH2 Suppresses Tumor Growth via Synergistic Induction of IL24-Mediated Apoptosis. Cancer Res. 2022 Apr 1;82(7):1208-1221. doi: 10.1158/0008-5472.CAN-21-2218.
Clinical trial NCT02642263: Effect of the Uterotonic Carbetocin on Acute Post Cesarean-Section Pain
Official title: Effect of the Uterotonic Carbetocin on Acute Post Cesarean-Section Pain, A Prospective Randomised Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Cesarean Delivery
Lead sponsor: Insel Gruppe AG, University Hospital Bern
Sponsor class: OTHER
First posted: 2015-12-30
Enrollment: 78
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Carbetocin is an oxytocin agonist used for prevention of postpartum bleeding after cesarean delivery. First studies revealed in 2012 an analgesic effect of carbetocin, compared to its parent substance oxytocin. This study will enroll 78 women undergoing cesarean delivery. In a double-blind, prospective design patients will be either attributed to the oxytocin or the carbetocin study arm. The primary endpoint will be the area of hyperalgesia around the cesarean delivery scar. This will be performed with a von Frey hair, resulting in a unpleasant feeling in the area of hyperalgesia.


Eligibility criteria: Inclusion Criteria:

* Age 18-45, uneventful pregnancy, on term (\>37 0/7 weeks of gestation), scheduled elective CS including repeat CS

Exclusion Criteria:

* lack of informed consent, active labor, multiple pregnancy, polyhydramnios, severe fetal malformations

Primary outcomes:
measure: Cesarean delivery scar cutaneous hyperalgesia
timeFrame: 4 hours after cesarean delivery
Secondary outcomes:
measure: Pressure pain detection threshold
timeFrame: before cesarean
measure: Pressure pain detection threshold
timeFrame: 4 hours after cesarean
measure: Pressure pain detection threshold
timeFrame: 24 hours after cesarean
measure: Pressure pain detection threshold
timeFrame: 48 hours after cesarean
measure: Pressure pain detection threshold
timeFrame: 6 weeks after cesarean
measure: Baseline depression detection
timeFrame: before cesarean
measure: Postpartum depression
timeFrame: 6 weeks post cesarean
measure: Cesarean delivery scar cutaneous hyperalgesia
timeFrame: 24 hours after cesarean
measure: Cesarean delivery scar cutaneous hyperalgesia
timeFrame: 48 hours after cesarean
measure: Cesarean delivery scar cutaneous hyperalgesia
timeFrame: 6 weeks after cesarean
Other outcomes:
Locations:
city: Bern
country: Switzerland
facility: Dep. of Anesthesiology and Pain Medicine, Bern University Hospital
Study officials:
affiliation: Bern University Hospital
name: Daniel Surbek, Prof
role: STUDY_DIRECTOR
References:
Clinical trial NCT06499363: Treprostinil in Newborns With Pulmonary Hypertension; a Non-Interventional Study to Collect Data on Drug Utilization, Safety, and Effectiveness
Official title: Treprostinil in Newborns With Pulmonary Hypertension; a Noninterventional Study to Collect Data on Drug Utilization, Safety, and Effectiveness.
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Persistent Pulmonary Hypertension of Newborn
Lead sponsor: Ferrer Internacional S.A.
Sponsor class: INDUSTRY
First posted: 2024-07-12
Enrollment: 60
Sex: ALL
Maximum age (years): 44
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Approximately 60 newborns with PH (of whom at least 40 newborns with persistent pulmonary hypertension of the newborn \[PPHN\]) are expected to be included.

Brief summary: This observational study will seek to describe the uses and safety and efficacy outcomes of treprostinil in clinical practice in patients with persistent pulmonary hypertension (PPHN).


Eligibility criteria: Inclusion Criteria:

1. Newborn infants who received at least one dose of IV or SC treprostinil as per clinical practice within 5 years from the moment of data collection.
2. Aged up to 44 weeks after conception at treprostinil initiation.
3. Pulmonary hypertension (PH) or suspicion of PH at the moment of treprostinil initiation.
4. Parent(s) or legally authorized representative(s) provides non-opposition consent for the patient participation in the study.
5. Newborn infants affiliated to French social security.

Exclusion Criteria:

* None.

Primary outcomes:
measure: Characteristics of neonates receiving treprostinil in the clinical practice.
timeFrame: From baseline to Day 30 after last dose of treprostinil
measure: Treprostinil-specific treatment patterns.
timeFrame: From baseline to Day 30 after last dose of treprostinil
measure: Number of participants with treatment-related adverse events to evaluate safety.
timeFrame: From baseline to Day 30 after last dose of treprostinil
Secondary outcomes:
measure: Composite endpoint of absence of complications through Day 14 after the index date.
timeFrame: From baseline to Day 30 after last dose of treprostinil
measure: Description of the clinical outcomes from treprostinil start day (i.e., Day 0) to Day 14 and at Day 30 after last dose of treprostinil.
timeFrame: 0h, 24h, 48h, 72h, Day 7, Day 14, and Day 30 after last dose of treprostinil (if applicable).
measure: Description of neurodevelopmental progress over 2 years after treprostinil initiation through a Global Clinical Impression Scale.
timeFrame: From day 30 after treprostinil treatment to Year 2 after last dose of treprostinil
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00620763: Calcium Retention as Influenced by Dietary Components That Induce an Acid Load
Official title: Calcium Retention in Postmenopausal Women as Influenced by Beef and Other Dietary Components That Induce an Acid Load
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: Meat protein
acid load
calcium retention
postmenopausal women
Lead sponsor: USDA Grand Forks Human Nutrition Research Center
Sponsor class: FED
First posted: 2008-02-21
Enrollment: 22
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: The impact of protein sources such as beef as part of Western diet on calcium retention remains controversial. We propose to test the hypothesis that the positive effect of high protein intake (especially from meat protein) can offset the negative effect of protein-induced net acid load on bone metabolism and the retention of body calcium. Healthy postmenopausal women recruited from the community will consume two diets differing in meat protein and acid load for 7 weeks. Calcium retention from diets will be determined using a highly sensitive measurement of whole body retention of a calcium isotope added to the diet.


Eligibility criteria: Inclusion Criteria:

* Average body mass index
* Normal blood work
* Normal bone density

Exclusion Criteria:

* Chronic disorder
* Non-traumatic bone fractures

Primary outcomes:
measure: Calcium Absorption
timeFrame: 18 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Grand Forks
country: United States
facility: United States Department of Agriculture (USDA) Grand Forks Human Nutrition Research Center
state: North Dakota
Study officials:
affiliation: USDA Grand Forks Human Nutrition Research Center
name: Jay Cao, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Roughead ZK, Johnson LK, Lykken GI, Hunt JR. Controlled high meat diets do not affect calcium retention or indices of bone status in healthy postmenopausal women. J Nutr. 2003 Apr;133(4):1020-6. doi: 10.1093/jn/133.4.1020.
citation: Cao JJ, Johnson LK, Hunt JR. A diet high in meat protein and potential renal acid load increases fractional calcium absorption and urinary calcium excretion without affecting markers of bone resorption or formation in postmenopausal women. J Nutr. 2011 Mar;141(3):391-7. doi: 10.3945/jn.110.129361. Epub 2011 Jan 19.
Clinical trial NCT05881863: To Investigate Airway Oxygen Concentrations During Rigid Bronchoscopy Procedures Performed With High Frequency Jet Ventilation
Official title: To Investigate Airway Oxygen Concentrations During Rigid Bronchoscopy Procedures Performed With High Frequency Jet Ventilation
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Central Airway Obstruction
Lead sponsor: University of Minnesota
Sponsor class: OTHER
First posted: 2023-05-31
Enrollment: 50
Sex: ALL
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: Patients undergoing rigid bronchoscopy for treatment of central airway obstruction at FV UMMC will be identified.

Brief summary: Thermal ablation (use of treatment modalities that generate heat) has become a widely used tool for treatment of central airway obstruction (e.g. laser, electrocautery, radiofrequency, and argon plasma coagulation). However, this method carries with it an increased risk for airway fire - a surgical fire that occurs in a patient's airway and could also include a fire in the attached breathing circuit. To decrease the risk of airway fire during mechanical ventilation with an endotracheal tube, the concentration of inspired oxygen (FiO2) is set below 40% while waiting for end tidal oxygen concentration (EtO2) to fall below 40% prior to starting thermal ablation. There is no published literature describing O2 concentration within the airways (AiO2) during jet ventilation with rigid bronchoscopy. The co-investigators of this study have recently collected data on AiO2 during rigid bronchoscopy using manual low frequency jet ventilation/high frequency jet ventilation with a period of apnea. The intent of this study is to measure the time taken for the central airway oxygen concentration to drop from 90 to 40% when the "laser mode" is activated on the Monsoon jet ventilator. Ventilation is continued during "laser mode."


Eligibility criteria: Inclusion Criteria:

* Patients undergoing rigid bronchoscopy for treatment of central airway obstruction at FV UMMC will be identified.
* 18 years or older
* Need rigid bronchoscopy as pre-determined by the interventional pulmonologist

Exclusion Criteria:

* Refusal to sign consent
* Pregnant patients
* Hemodynamic instability defined as continuous infusion of medication in order to support blood pressure and/or heart rate/rhythm
* Respiratory instability defined as SpO2\&lt;90% with \&gt;90% supplemental oxygen.
* Ineligible for rigid bronchoscopic intubation
* Latex allergy
* Evidence of fistulous airway
* Active Bronchopleural fistula

Primary outcomes:
measure: Time in seconds to AiO2 from 90 to 40%
timeFrame: baseline
Secondary outcomes:
measure: Differences in time to laser mode AiO2
timeFrame: baseline
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
Study officials:
affiliation: University of Minnesota
name: Sudarshan Setty, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04065763: Correlation of the Dural Sac Dimension With the Spread of Spinal Anesthesia
Official title: Correlation of the Dural Sac Dimension With the Spread of Spinal Anesthesia in Elderly Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Elderly Patients
Lead sponsor: SMG-SNU Boramae Medical Center
Sponsor class: OTHER
First posted: 2019-08-22
Enrollment: 41
Sex: FEMALE
Minimum age (years): 65
Standard ages: OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Female patients older than 65 years of age who are undergoing elective surgery under spinal anesthesia

Brief summary: Cerebrospinal fluid volume is an important factor that influences peak block height and regression of sensory and motor blockade. The aim of this study is to evaluate the effect of dural sac dimension on the spread of spinal anesthesia in elderly patient using ultrasound.


Eligibility criteria: Inclusion Criteria:

* Patients who are scheduled for elective surgery under spinal anesthesia

Exclusion Criteria:

* Known anatomical abnormality or pathology in the spine
* History of lumbar spinal surgery or compression fracture
* Height less than 150 cm

Primary outcomes:
measure: Correlation between the dural sac dimension and spinal anesthesia spread (peak sensory block)
timeFrame: At 30 minutes after the induction of spinal anesthesia
Secondary outcomes:
measure: Correlation between the dural sac dimension and duration of spinal anesthesia
timeFrame: At 30 minutes after the end of surgery
measure: Correlation between the dural sac dimension and body mass index
timeFrame: 5 minutes before spinal anesthesia
measure: Correlation between the dural sac dimension and waist circumference
timeFrame: 5 minutes before spinal anesthesia
measure: Correlation between the dural sac dimension and age
timeFrame: 5 minutes before spinal anesthesia
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: SMG-SNU Boramae Medical Center
Study officials:
References: