louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05157945: ALTO-300 in Depression (ALTO-300-004)
Official title: AN OPEN-LABEL STUDY OF ALTO-300 IN ADULTS WITH MAJOR DEPRESSIVE DISORDER
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Major Depressive Disorder
Lead sponsor: Alto Neuroscience
Sponsor class: INDUSTRY
First posted: 2021-12-15
Enrollment: 148
Sex: ALL
Minimum age (years): 18
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to collect biologically-based data for defining predictors and correlates of the effects of ALTO-300.


Eligibility criteria: Inclusion Criteria:

* Have a diagnosis of moderate to severe major depressive disorder
* Currently taking a SSRI, SNRI, or bupropion for at least 6 weeks with no dose modifications in the past 2 weeks
* Must have failed to adequately respond to the current antidepressant medication
* Willing to comply with all study assessments and procedures
* Must not be pregnant or breastfeeding at time of enrollment or throughout study

Exclusion Criteria:

* Evidence of liver impairment or disease
* Active suicidal ideation
* Moderate to severe Alcohol Use Disorder
* Diagnosed bipolar disorder or psychotic disorder
* Has a history of hypersensitivity or allergic reaction to ALTO-300 or any of its components/excipients
* Concurrent or recent participation in another clinical trial for mental illness involving an investigational product or device

Primary outcomes:
measure: To understand the relationship between baseline biology and change in the Montgomery-Asberg Depression Rating Scale (MADRS) with ALTO-300
timeFrame: Measured 6 times over 8 weeks
measure: To understand the relationship between baseline biology and change in the Clinical Global Impression scale - Severity (CGI-S) with ALTO-300
timeFrame: Measured 6 times over 8 weeks
measure: Number of Participants with Adverse Events (AEs) as a Measure of Safety and Tolerability of ALTO-300
timeFrame: From the signing of the ICF until the follow-up visit (up to 12 weeks)
measure: Number of Participants With Clinically Significant Vital Signs Abnormalities as a Measure of Safety and Tolerability of ALTO-300
timeFrame: From the signing of the ICF until the end-of-treatment visit (up to 11 weeks)]
measure: Number of Participants With Clinically Significant Laboratory Abnormalities as a Measure of Safety and Tolerability of ALTO-300
timeFrame: From the signing of the ICF until the end-of-treatment visit (up to 11 weeks)]
Secondary outcomes:
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Cerebral - Atlanta
state: Georgia
city: Jackson
country: United States
facility: Site 171
state: Mississippi
city: New York
country: United States
facility: Cerebral - New York City
state: New York
city: Dallas
country: United States
facility: Cerebral - Dallas
state: Texas
Study officials:
References:
Clinical trial NCT05720845: Effects of Different Ventilatory Strategy on Intraoperative Atelectasis During Bronchoscopy Under General Anesthesia.
Official title: Effects of Different Ventilatory Strategy on Intraoperative Atelectasis During Bronchoscopy Under General Anesthesia.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Lung Disorder
Keywords: atelectasis
general anesthesia
Lead sponsor: Guangzhou Institute of Respiratory Disease
Sponsor class: OTHER
First posted: 2023-02-09
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: This trial compares two different types of ventilation for the prevention of partial or complete collapsed lung (atelectasis) in patients undergoing interventional pulmonology procedures under general anesthesia. Ventilatory strategy to prevent reduce the intra-procedural development of atelectasis during interventional pulmonology procedures under general anesthesia.


Eligibility criteria: Inclusion Criteria:

* Adult patients undergoing interventional pulmonology procedures with radial probe endobronchial ultrasound (RP-EBUS) for peripheral lung lesions
* Recent (\< 4 weeks) chest computed tomography (CT) performed prior to the bronchoscopy

Exclusion Criteria:

* Patients with baseline lung consolidation, interstitial changes or lung masses (\> 3 cm in diameter) in dependent areas of the lung (right/left \[R/L\] B6, 9, or 10 bronchial segments) as seen on most recent CT
* History of primary or secondary spontaneous pneumothorax

Primary outcomes:
measure: Presence or absence of new atelectasis for each segment
timeFrame: During bronchoscopy, an average of 1 hour.
Secondary outcomes:
measure: Ventilation-induced complications
timeFrame: Within 48 hours of bronchoscopy
measure: Bronchoscopy-induced complications
timeFrame: Within 48 hours of bronchoscopy
measure: Assess the regional ventilation distribution by Electrical impedance tomography (EIT)
timeFrame: During bronchoscopy, an average of 1 hour.
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Guangzhou Institute of Respiratory Disease, The First Affiliated Hospital of Guangzhou Medical University
state: Guangdong
Study officials:
References:
Clinical trial NCT00717145: Food Effects on the Relative Bioavailability of Different Dosages of Risedronate
Official title: Food Effects on the Relative Bioavailability of a Risedronate 20 mg Delayed-release [DR] Tablet and to Compare the 20 mg DR Tablet to 35 mg DR and 35 mg Immediate-release Tablets
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Postmenopausal
Non-lactating
Surgically Sterile
Keywords: bioequivalence
Lead sponsor: Warner Chilcott
Sponsor class: INDUSTRY
Collaborators: name: Sanofi
First posted: 2008-07-16
Enrollment: 94
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief summary: Randomized, open-label, multi-center, 4-treatment, 4-period crossover study. The study will consist of a screening visit, study center admission (preceding Treatment Periods 1, 2, 3, and 4), 4 treatment periods (4 days each), 3 washout periods (14 to 17 days in duration separating each treatment period), and exit procedures.


Eligibility criteria: Inclusion Criteria:

* non-lactating and either surgically sterile or postmenopausal:
* body mass index less than or equal to 32 kg/m2 at screening

Exclusion Criteria:

* No use of a bisphosphonate within 1 month
* no history of GI disease
* no use of any medications within 7-14 days prior to scheduled dosing day

Primary outcomes:
measure: Assess the relative bioavailability of the risedronate 20 mg DR tablet administered immediately after a high-fat meal compared to the risedronate 35 mg IR tablet administered 30 minutes prior to a high-fat meal.
timeFrame: 4 Days
Secondary outcomes:
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: Research Site
state: Florida
city: Miramar
country: United States
facility: Research site
state: Florida
city: Austin
country: United States
facility: Research Site
state: Texas
Study officials:
References:
Clinical trial NCT02854345: Preliminary Study Concerning the Validity of Parathyroid Exploration on a CZT Camera
Official title: Preliminary Study Concerning the Validity of Parathyroid Exploration on a Discovery NM 530c CZT Camera
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Primary Hyperparathyroidism
Keywords: CZT camera
pinhole
Lead sponsor: Centre Hospitalier Universitaire de Besancon
Sponsor class: OTHER
First posted: 2016-08-03
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The goal of this study is to assess the performance of parathyroid imaging on a cardiac-dedicated CZT camera, compared to planar pinhole imaging, in patients referred for primary hyperparathyroidism.

Detailed description: The goal is to determine if parathyroid tomoscintigraphy on a CZT camera can provide at least equivalent diagnostic performance, compared with planar pinhole imaging.

Eligibility criteria: Inclusion Criteria:

* suffering from sporadic primary hyperparathyroidism
* referred to the Nuclear Medicine Dept for a pre-operative scintigraphy of the parathyroid glands
* who have given their written consent
* who benefit from the French Government Medical Insurance

Exclusion Criteria:

* pregnant women
* ages \< 18 or \> 80 years
* hyperparathyroidism recidive after a first surgery
* secondary or tertiary hyperparathyroidism
* Multiple endocrine Neoplasia (MEN) type I context or familial history of hyperparathyroidism
* absence of written consent
* non-beneficiary of the French Government Medical Insurance

Primary outcomes:
measure: Comparison of pathologic parathyroid detection performances between planar pinhole on Anger camera and tomoscintigraphy on CZT camera, gold standard being the pathological results after surgery
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Besancon
country: France
facility: CHU Besancon
Study officials:
affiliation: Centre Hospitalier Universitaire de Besancon
name: Constantin Ungureanu, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00334945: Evaluate the Effect of Growth Hormone (GH) Treatment on Fibroblast Growth Factor 23, a Known Phosphaturic Agent
Official title: Evaluate the Effect of Growth Hormone (GH) Treatment on Fibroblast Growth Factor 23 (a Known Phosphaturic Agent)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Growth Disorders
Keywords: Fibroblast Growth Factors
Bone development
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
Collaborators: name: Genentech, Inc.
First posted: 2006-06-08
Enrollment: 35
Sex: ALL
Minimum age (years): 3
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children attending Endocrinology clinics of Children's Hospital of Alabama. Ages are 3-14 years of age.

Brief summary: The purpose of this study is to evaluate the effect of growth hormone treatment on phosphorus levels in the body. Phosphorus is an important mineral for bone growth. It is well known that growth hormone treatment improves bone density and bone mineral content. The amount of phosphorus is maintained by the kidneys. Fibroblast Growth Factor 23 has recently been recognized to help kidneys control phosphate levels.

Detailed description: This study will compare Fibroblast Growth Factor 23 levels in children with and without growth hormone deficiency. Children with growth hormone deficiency will have levels taken before starting growth hormone replacement and after it has been initiated.

Eligibility criteria: Inclusion Criteria:

* Twenty children with significant short stature \< 3rd percentile, ages 3-14 years, and referred to Children's Hospital of Alabama
* Normal healthy volunteer children 3-18 years with normal stature

Exclusion Criteria:

* Patients on medication including GH
* Patients with concomitant hormonal abnormalities
* Patients with disorders of calcium and phosphate metabolism
* Active neoplasms
* Closed epiphysis
* Known bone disorders

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University of Alabama at Birmingham
name: Ambika Ashraf, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05963945: Multi-Reader Retrospective Study Examining Carebot AI CXR 2.0.21-v2.01 Implementation in Everyday Radiology Clinical Practice
Official title: Multi-Reader Retrospective Study Examining Carebot AI CXR 2.0.21-v2.01 Implementation in Everyday Radiology Clinical Practice
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pneumothorax
Pulmonary Nodule, Solitary
Atelectasis
Subcutaneous Emphysema
Cardiomegaly
Consolidation
Pleural Effusion
Keywords: Artificial Intelligence
Computer-Aided Detection
Deep Learning
Chest X-ray
Radiology
Lead sponsor: Carebot s.r.o.
Sponsor class: INDUSTRY
First posted: 2023-07-27
Enrollment: 956
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient's Sex Female: 480 (50.21 %) Male: 474 (49.58 %) Unspecified: 2 (0.21 %)

Patient's Age 18-30: 58 (6.07 %) 31-50: 163 (17.05 %) 51-70: 366 38.28 %) 70+: 369 (38.60 %)

Brief summary: The primary objective is to evaluate the performance parameters of the proposed DLAD (Carebot AI CXR) in comparison to individual radiologists.

Detailed description: In the period between October 18th, 2022, and November 17th, 2022, anonymized chest X-ray images of patients were collected at the Radiodiagnostic Department of the Havířov Hospital, p.o. The collection process involved utilizing the CloudPACS imaging and archiving system provided by OR-CZ spol. s r.o.

The collected X-ray images were subjected to the proposed DLAD (Carebot AI CXR) for analysis. Subsequently, the DLAD's performance was compared with the standard clinical practice, where radiologists assessed the CXR images in the simulated hospital setting with access to standard viewing tools (e.g., pan, zoom, WW/WL) and were given an unlimited amount of time to complete the review. Each radiologist determined the presence or absence of 7 indicated radiological findings, including atelectasis (ATE), consolidation (CON), pleural effusion (EFF), pulmonary lesion (LES), subcutaneous emphysema (SCE), cardiomegaly (CMG), and pneumothorax (PNO).

Eligibility criteria: Inclusion Criteria:

* Hospital patients \> 18 years who were referred for chest radiography October 18th, 2022, and November 17th, 2022 at the Radiodiagnostic Department of the Havířov Hospital, p.o.

Exclusion Criteria:

* Patients \< 18 years
* Chest X-ray images in lateral positions
* Duplicated chest X-ray images

Primary outcomes:
measure: Performance test
timeFrame: March 2023
Secondary outcomes:
Other outcomes:
Locations:
city: Havířov
country: Czechia
facility: Nemocnice Havířov, p. o.
Study officials:
References:
citation: KVAK, Daniel, Anna CHROMCOVÁ, Petra OVESNÁ, Jakub DANDÁR, Marek BIROŠ, Robert HRUBÝ, Daniel DUFEK a Marija PAJDAKOVIĆ. Can Deep Learning Reliably Recognize Abnormality Patterns on Chest X-rays? A Multi-Reader Study Examining One Month of AI Implementation in Everyday Radiology Clinical Practice. arXiv. 2023, 2305.10116, 26 s.
Clinical trial NCT03841045: Unraveling a Potential Connection Between Bilirubin Metabolism, Gut Microbiota and Inflammatory Bowel Diseases
Official title: Unraveling a Potential Connection Between Bilirubin Metabolism, Gut Microbiota and Inflammatory Bowel Diseases
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Colitis, Ulcerative
Crohn Disease
Lead sponsor: Soroka University Medical Center
Sponsor class: OTHER
First posted: 2019-02-15
Enrollment: 150
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: people that have UC, CD diagnosis and healthy can participate in the study. the disease can be at any level and the patients can handle any medications.

each participant will give fresh stool, saliva and skin samples during the study. only one visit is planned in the study-for sighning ICF and returning samples.

Brief summary: Inflammatory Bowel Diseases (IBDs) are a set of recurrent inflammatory conditions that include the colon and small intestine. The two principal conditions include Crohn's disease (CD) and ulcerative colitis (UC). The etiology of which is likely to stem from the interplay of gut microbial imbalances and host. In this study stool cultures, saliva and skin samples will be taken from all participants.

Detailed description: Recent studies have shown that certain CD patients harbor microbial communities that are distinct from those of healthy individuals. These studies suggest a central role of the gut microbial population in CD. The high complexity of the gut microbiome, which is the most densely populated bacterial niche, makes the identification of these bacteria a significant challenge. The bacterial population is comprised from 1013 - 1014 individuals, all belonging roughly to a thousand different species, mostly anaerobic, and most of them (roughly 70% - 80%) are uncultivable.

The goals of this project are to examine a potential link between bilirubin metabolism and IBD, by comparing fecal extracts from healthy humans and IBD patients, and to investigate the underlying mechanism explaining these differences.

Eligibility criteria: Inclusion Criteria:

* UC
* CD
* healthy Volunteers

Exclusion Criteria:

• N/A

Primary outcomes:
measure: change of bilirubin metabolism in fecal samples
timeFrame: an average of 1 year after recruitment
measure: microbial diversity of fecal matter
timeFrame: an average of 1 year after recruitment
Secondary outcomes:
Other outcomes:
Locations:
city: Be'er Sheva
country: Israel
facility: soroka MC
Study officials:
affiliation: SOROKA MC
name: ARIK SEGAL, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01254045: Double-blind Placebo Controlled Study of Oxytocin in Fragile X Syndrome
Official title: Double-blind Placebo Controlled Study of Oxytocin in Fragile X Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Fragile X Syndrome
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2010-12-06
Enrollment: 10
Sex: MALE
Minimum age (years): 13
Maximum age (years): 29
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether the medication oxytocin is an effective and tolerable treatment in adolescent males with fragile X syndrome (FraX) for improving socially appropriate behaviors and reducing social anxiety.

Detailed description: Twelve male adolescent (13-24 years) subjects with confirmed genetic diagnosis of FraX (full mutation) will participate in this randomized double-blind placebo-controlled study. They will receive a dose of either 24 IU oxytocin, 48 IU oxytocin or placebo at each of three visits to the lab, with each visit spaced one week apart. The efficacy of each dose will be evaluated using behavioral, cognitive and physiological metrics. If individual subject results suggest that either of the oxytocin dosage levels (24 IU or 48 IU) is superior to placebo in the double-blind phase, a single-blind trial using the optimal dosage of oxytocin will then be administered daily for 14 days by parents at home. Subjects will then come into the lab for a final assessment on Day 30. Determination of beneficial response to oxytocin will be based on a 20% change (improvement) in behavior or test performance (see below). If both oxytocin dosage levels provide similar benefits compared to placebo, the lower dose will be chosen for the 14 day single-blind trial.

Eligibility criteria: Inclusion Criteria:

1. Confirmed genetic diagnosis of Fragile X (FraX) (full mutation).
2. Male (who have more serious effects due to the X chromosome nature of the disorder)
3. Age 13-29 years.
4. Parent of adolescent must be willing to sign informed consent.
5. Intelligence Quotient (IQ) \> 42.

Exclusion Criteria:

1. Cardiac risk factors.
2. Medication exclusions: opiates or opiate antagonists, corticosteroids, typical or atypical antipsychotics.

Primary outcomes:
measure: Eye Contact/Gaze During 10 Minute Social Challenge Task
timeFrame: baseline, week 2, and week 3
Secondary outcomes:
measure: Salivary Cortisol
timeFrame: baseline, week 2, and week 3
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University School of Medicine
state: California
Study officials:
affiliation: Stanford University
name: Allan L Reiss
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hall SS, Lightbody AA, McCarthy BE, Parker KJ, Reiss AL. Effects of intranasal oxytocin on social anxiety in males with fragile X syndrome. Psychoneuroendocrinology. 2012 Apr;37(4):509-18. doi: 10.1016/j.psyneuen.2011.07.020. Epub 2011 Aug 20.
Clinical trial NCT03139045: Impact of VeinViewer® Vision to Guide Peripheral Venipuncture in Geriatrics
Official title: Impact of VeinViewer® Vision to Guide Peripheral Venipuncture in Geriatrics
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Venipuncture
Geriatric
Lead sponsor: Centre Hospitalier Universitaire, Amiens
Sponsor class: OTHER
First posted: 2017-05-03
Enrollment: 200
Sex: ALL
Minimum age (years): 75
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: Peripheral venipuncture is a common procedure in geriatrics. This procedure due to altered cutaneous alteration and venous capital associated with age poses problems of comfort and quality of life of elderly patients hospitalized. There is little data from the literature that highlights the difficulties of venipuncture in the context of old age. New venous visualization technologies by infrared spectroscopy (NIR) such as VeinViewer® Vision (VVV) have been developed to guide the placement of a peripheral venous (VVP) or venipuncture (PV) route.


Eligibility criteria: Inclusion Criteria:

* Patient aged 75 years and over
* Patient hospitalized in a department of acute geriatrics, whose venipuncture was prescribed

Exclusion Criteria:

* Patient not affiliated to a social security scheme
* Patient under legal protection

Primary outcomes:
measure: Quantification of the number of attempts to place the venous catheter for venipuncture
timeFrame: 3 days
Secondary outcomes:
Other outcomes:
Locations:
city: Amiens
country: France
facility: CHU Amiens Picardie
state: Picardie
Study officials:
References: