louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03736772: A Study of LY3090106 in Japanese and Caucasian Healthy Participants
Official title: A Single-Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of LY3090106 in Japanese and Caucasian Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2018-11-09
Enrollment: 30
Sex: ALL
Minimum age (years): 20
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The main purpose of this study is to evaluate the safety of a study drug known as LY3090106 in healthy Caucasian and Japanese participants. Side effects and tolerability will be documented. Blood samples will be taken to compare how the body handles the drug. The study will last about 12 weeks, not including screening or additional follow-up.


Eligibility criteria: Inclusion Criteria:

* Overtly healthy Japanese or Caucasian
* Body mass index (BMI) 18.0 - 32.0 kilograms per square meter (kg/m²)

Exclusion Criteria:

* Have participated, within the last 30 days, in a clinical study involving an investigational product (IP). If the previous IP has a long half-life, 5 half-lives or 30 days (whichever is longer) should have passed
* Have had symptomatic herpes zoster within 3 months of screening
* Show evidence of active or latent tuberculosis (TB)
* Have known hypogammaglobulinemia or a screening serum immunoglobulin (Ig) G \<565 milligrams per deciliter (mg/dL)
* Have received live or attenuated vaccine(s) within 1 month of screening, or intend to during the study
* Are immunocompromised
* Have received treatment with biologic agents (such as monoclonal antibodies, including marketed drugs) within 3 months or 5 half-lives (whichever is longer) prior to dosing. Participants with any prior exposure to ixekizumab, tabalumab or other biologic agents directly targeting Interleukin 17 (IL-17) and/or B cells (e.g., rituximab, belimumab, etc.) are excluded

Primary outcomes:
measure: Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration
timeFrame: Baseline through Day 85
Secondary outcomes:
measure: Maximum Observed Drug Concentration (Cmax) of LY3090106
timeFrame: Baseline through Day 85
measure: Area Under the Concentration-Versus-Time Curve (AUC) of LY3090106
timeFrame: Baseline through Day 85
Other outcomes:
Locations:
city: Anaheim
country: United States
facility: Anaheim Clinical Trials, LLC
state: California
Study officials:
affiliation: Eli Lilly and Company
name: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
role: STUDY_DIRECTOR
References:
Clinical trial NCT03214172: Characterizing Recurrent Thromboembolism, Major Bleeding and All-Cause Death in Patients With Cancer-Associated Thromboembolism Treated With Rivaroxaban
Official title: Characterizing Recurrent Thromboembolism, Major Bleeding and All-Cause Death in Patients With Cancer-Associated Thromboembolism Treated With Rivaroxaban
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Venous Thromboembolism
Lead sponsor: Bayer
Sponsor class: INDUSTRY
Collaborators: name: Janssen Research & Development, LLC
First posted: 2017-07-11
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Truven Health MarketScan Commercial Claims and Medicare Supplemental Databases is used. The Truven Health MarketScan® Research Databases capture person-specific clinical utilization, expenditures, and enrollment across inpatient, outpatient, prescription drug, and carve-out services. Individuals enrolled in the MarketScan databases are largely representative of the United States population in terms of age, sex, and type of health insurance coverage. The data come from a selection of large employers, health plans, and government and public organizations and contain claims from approximately 100 employers, health plans, and government and public organizations representing about 50 million covered lives across all age groups. The data elements to be used in the proposed study will include health plan enrollment records, participant demographics, inpatient and outpatient medical claims and outpatient prescription drug dispensing records.

Brief summary: To estimate the real-world rates of recurrent Venous thromboembolism (VTE), major bleeding and all-cause mortality in patients with Cancer-associated thrombosis (CAT) treated with rivaroxaban


Eligibility criteria: Inclusion Criteria:

* Adult patients (≥18 years-of-age) with active cancer
* Patient with at least one index venous thromboembolism (VTE )
* ≥6-months of continuous eligibility prior to the index VTE event (baseline period).
* Newly initiated on rivaroxaban

Exclusion Criteria:

* Patients with any medical claim for Deep vein thrombosis (DVT) or Pulmonary embolism (PE) during the 6 months pre-index date
* Patients with prescription claim for anticoagulation therapy during the 6-month pre-index VTE period

Primary outcomes:
measure: Recurrent Venous thromboembolism
timeFrame: Retrospective analysis from November 2012 through September 2015
measure: Bleeding (based on the Cunningham algorithm)
timeFrame: Retrospective analysis from November 2012 through September 2015
measure: Mortality (In-hospital mortality or need for hospice care without subsequent healthcare claims)
timeFrame: Retrospective analysis from November 2012 through September 2015
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: US database
state: New York
Study officials:
References:
Clinical trial NCT00584272: Retrospective Study on the Outcome of Cleft Palate Repair: Comparing US Surgical and Ethicon Suture Materials
Official title: Retrospective Study on the Outcome of Cleft Palate Repair: Comparing US Surgical and Ethicon Suture Materials
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cleft Palate
Keywords: cleft palate
suture materials
Lead sponsor: University of California, Davis
Sponsor class: OTHER
First posted: 2008-01-02
Enrollment: 88
Sex: ALL
Minimum age (years): 1
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: UCDMC pediatric clinic

Brief summary: Investigator initiated retrospective chart review to study the effects of changing suture material on the healing and outcome of cleft palate surgery were.

Detailed description: This study aims to show what the effects of changing suture material were on the healing and outcome of cleft palate surgery. The study will be considered successful if we find that either there is an effect on the healing after surgery, one of the suture materials seems to promote better healing and final outcome, or that there is no difference between the suture materials.

Eligibility criteria: Inclusion Criteria:

* Cleft palate repair performed at UCDMC between 1/1996 and 6/2006

Exclusion Criteria:

* Those who do not meet the inclusion criteria

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Sacramento
country: United States
facility: University of California Davis Medical Center
state: California
Study officials:
affiliation: University of California, Davis
name: Craig W. Senders, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06770972: Family Foundations for Individuals Pregnant Via ART
Official title: Family Foundations for Individuals Pregnant Via Assisted Reproductive Technology
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Assisted Reproductive Technology
Keywords: Assisted Reproductive Technology
mental health outcomes
single individuals pregnant
Lead sponsor: Cedars-Sinai Medical Center
Sponsor class: OTHER
First posted: 2025-01-13
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The purpose of this study is to help expectant single mothers build a coparenting bond and improve communication with a support person (co-caregiver). Participation will include completing two online surveys (one at 12-30 weeks gestation \& one at 3 months postpartum), providing two at-home bloodspot collections and return via mail. Studies suggest that stress increases inflammation. Investigators aim to explore this by collecting a small amount of blood at the first and last session; attending 9 virtual one-two hour Family Foundations (FF) intervention sessions (at no cost to participants) with a supportive co-caregiver (total time commitment will be 18 hours, max, over a 6 month period).


Eligibility criteria: Inclusion Criteria:

1. Pregnant individuals via ART, at least 18 years of age
2. Self-identify as a single parent
3. Have a caregiving partner (e.g. grandparent; nanny; friend) who will attend sessions
4. Provision of signed and dated informed consent form
5. Stated willingness to comply with all study procedures and availability for the duration of the study
6. English speaking
7. Access to and familiarity with a tablet, smartphone, or computer

Exclusion Criteria:

1. Psychosis
2. Perinatal loss (current) - history of loss is OK
3. Individuals outside of the US
4. Do not have smartphones, tablets, computers (the FF class is virtual)

Primary outcomes:
measure: Change in Depressive Symptoms
timeFrame: From enrollment to the end of intervention at 6 months postpartum
measure: Change in social support
timeFrame: From enrollment to the end of intervention at 6 months postpartum
measure: Change in Anxiety Symptoms
timeFrame: From enrollment to the end of intervention at 6 months postpartum
measure: Change in symptoms of perceived stress
timeFrame: From enrollment to the end of intervention at 6 months postpartum
measure: Change in communication
timeFrame: From enrollment to the end of intervention at 6 months postpartum
measure: Change in symptoms of post-traumatic stress
timeFrame: From enrollment to the end of intervention at 6 months postpartum
Secondary outcomes:
measure: Change in levels of high sensitivity C-reactive protein (mg/dL)
timeFrame: From enrollment to the end of treatment at 6 months postpartum
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Cedars Sinai Medical Center
state: California
Study officials:
References:
Clinical trial NCT05634772: Dormia Basket Versus Extraction Ballon in Proximally Migrated Biliary Stents
Official title: Dormia Basket Versus Extraction Ballon in Proximally Migrated Biliary Stents:A Randomized Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Biliary Obstruction
Lead sponsor: Kafrelsheikh University
Sponsor class: OTHER
First posted: 2022-12-02
Enrollment: 80
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: Dormia basket versus extraction ballon in proximally migrated biliary stents:A randomized controlled clinical trial

Detailed description: Dormia basket versus extraction ballon in proximally migrated biliary stents:A randomized controlled clinical trial The study aims to evaluate the efficacy of dormia basket versus extraction biliary balloon in management of proximal stent migration

Eligibility criteria: Inclusion Criteria:

1. Adults
2. both gender
3. Patients with biliary stenting following ERCP and who had signs of biliary obstruction.

Exclusion Criteria:

ERCP without stent insertion.

Primary outcomes:
measure: To compare between dormia basket and extraction ballon in management of proximally migrated biliary stents regarding operative time (min)
timeFrame: 4 weeks
Secondary outcomes:
Other outcomes:
measure: To compare between dormia basket and extraction ballon regarding occurrence of re- obstruction
timeFrame: 4 weeks
Locations:
city: Kafr Ash Shaykh
country: Egypt
facility: Mohamed Hussien Ahmed
Study officials:
References:
Clinical trial NCT05594368: Dose Escalation for SBRT of Recurrent VT Ventricular Tachyarrhythmia - a Single Center, Phase II Clinical Trial
Official title: Dose Escalation for Stereotactic Cardiac Radiation Therapy of Recurrent Ventricular Tachyarrhythmia - a Multi Center, Phase II Clinical Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Ventricular Tachycardia
Lead sponsor: University of Zurich
Sponsor class: OTHER
First posted: 2022-10-26
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: The study is designed as a one arm, multi-center dose escalation trial employing the i3+3 design.
Primary purpose: TREATMENT

Brief summary: The objective of this study is to demonstrate that higher radiation doses are necessary to induce transmural scar formation which is currently assumed to be the underlying mechanism of successful long-term efficacy of VT treatment and therefore dose-escalation will lead to a significantly reduced long-term VT recurrence rate compared to the currently applied single dose of 25 Gy.


Eligibility criteria: Inclusion Criteria:

Patients with structural heart disease, in particular ischemic and non-ischemic cardiomyopathy: Implanted ICD and/or CRT-D. Prior ≥1 failed catheter ablation (with endocardial ± epicardial approach based on the substrate location and the ECG morphology of clinical VTs) procedure to control sustained monomorphic VT using currently recommended mapping and ablation techniques,2 or patients in whom ablation is not feasible. Reasons for lack of epicardial ablation and non-feasibility of catheter ablation must be specified. Sustained VT recurrence after catheter ablation on optimised antiarrhythmic medication.

Age ≥18 years. IRB-approved, written informed consent must be provided

Exclusion Criteria:

Patients with only premature ventricular contractions.

Patients with sustained VT/VF who demonstrate:

Acute myocardial infarction; Primary electrical disease (channelopathy); Reversible and treatable cause (e.g., drug-induced or intoxication) of VT that can be adequately addressed otherwise; A target that cannot be safely and precisely defined based on stereotactic radiotherapy accuracy requirements (e.g., anatomical interference from OARs, overlapping prior radiation therapy to the thoracic region); Pregnancy or breastfeeding; Inability to provide informed consent.

Primary outcomes:
measure: safety measured by registered radiation associated adverse events up to 90 days
timeFrame: up to 90 days
Secondary outcomes:
measure: Radiation associated serious adverse event (at least grade 4 or 5 according to CTCAE v5)
timeFrame: As assessed at 90 days
Other outcomes:
Locations:
city: Ostrava
country: Czech Republic
facility: University Hospital Ostrava
city: Zürich
country: Switzerland
facility: University Hospital Zurich
state: Zurich
Study officials:
References:
Clinical trial NCT01046968: Lepticore in Metabolic Syndrome and Weight Loss
Official title: The Use of LeptiCore® in Reducing Fat Gain and Managing Weight Loss in Patients With Metabolic Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Obesity
Hyperlipidemia
Hyperglycemia
Keywords: Obesity
metabolic syndrome
C-reactive protein
Leptin
Lead sponsor: University of Yaounde 1
Sponsor class: OTHER
Collaborators: name: Cameroon Nutritional Science Society
First posted: 2010-01-12
Enrollment: 92
Sex: ALL
Minimum age (years): 19
Maximum age (years): 52
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: Metabolic syndrome is directly related to obesity. This study investigated the use of a plant based formulation to improve on the condition of people with metabolic syndrome.

Detailed description: LeptiCore is a proprietary combination of various ingredients which have been shown to have properties which could be beneficial to weight loss in obese and overweight human subjects. This study evaluates the effect of Lepticore on bodyweight as well as parameters associated with obesity and metabolic syndrome.

The study was an 8 week randomized, double-blind, placebo-controlled design involving 92 obese (mean BMI\>30kg/m2) participants (37 males; 55 females; ages 19-52; mean age = 30.7). The participants were randomly divided into three groups: placebo (n=30), LeptiCore formula A (low dose) (n=31) and LeptiCore formula B (high dose) (n=31). Capsules containing the placebo or active formulations were administered twice daily before meals with 300 ml of water. None of the participants followed any specific diet nor took any weight-reducing medications for the duration of the study. A total of 12 anthropomorphic and serological measurements were taken at the beginning of the study and after 2, 4, 6, and 8 weeks of treatment.

Eligibility criteria: Inclusion Criteria:

* BMI \>30 kg/m2
* Total cholesterol \>200 mg/dl
* LDL cholesterol \>160 mg/dl
* HDL cholesterol \<40 mg/dl; triglycerides \>150 mg/dl
* Fasting blood glucose \>100 mg/dl
* Blood pressure \>130/85 mmHg.

Exclusion Criteria:

* Morbid obesity (BMI \>40 kg/m2 )
* Diabetes mellitus requiring daily insulin management
* Pregnancy/lactation
* Active infection
* Systemic disease such as HIV/AIDS,
* Use of any cholesterol-lowering medications 30 days prior to study
* Enrollment in another clinical study within the past 6 months.

Primary outcomes:
measure: Improvement of symptoms of metabolic syndrome
timeFrame: 8 weeks
Secondary outcomes:
measure: Change in weight
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Yaounde
country: Cameroon
facility: Laboratory of Nutrition and Nutritional Biochemistry
state: Centre
Study officials:
affiliation: University of Yaounde 1
name: Julius E Oben, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02179268: Antidepressants and Bone Mineral Density
Official title: International Committee of Medical Journal Editors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Bone Mineral Density Quantitative Trait Locus 7
Keywords: Antidepressants
bone mineral density
bone turnover markers
Lead sponsor: Guiyang Medical University
Sponsor class: OTHER
First posted: 2014-07-01
Enrollment: 203
Sex: ALL
Minimum age (years): 20
Maximum age (years): 48
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: The aim of this five arm randomized trial was thus to compare selective serotonin reuptake inhibitor (SSRI)sertraline and citalopram to a dual reuptake inhibitor venlafaxine, a nor-adrenaline reuptake inhibitor reboxetine and a control group receiving placebo, with the primary endpoint being bone mineral density, and secondary endpoints being bone turnover markers.

Detailed description: These results have overt clinical implications. They suggest a noxious effect, particularly of selective serotonin reuptake inhibitor (SSRI) antidepressants, on bone. Osteoporosis and fracture is overtly the problem of the elderly. However, the process of skeletal consolidation begins in childhood and the corresponding phase of demineralisation proceeds at a glacial pace and lasts throughout adulthood, as a consequence antidepressant therapy is likely to have a substantive impact on a phenomenon likely to manifest decades hence. It is known that numerically small changes in bone mineral density are associated with a substantial increase in fracture risk. Because the SSRIs have only been in widespread use for two decades, it is plausible that the consequences of this adverse effect are yet to emerge. These data consequently suggest a recalibration of the risk/benefit ratio of this class of agents and additionally beg the question of the potential role of screening for bone mineral density in this at-risk population group.

Eligibility criteria: Inclusion Criteria:

* Participants needed to have a primary diagnosis of depression with Zung Self Rated Depression Scale (SDS) \> 53, and Hamilton Depression Scale (HAMD) ≥20.

Exclusion Criteria:

* The patients with hyperparathyroidism, myeloma or other disorders known to affect bone metabolism
* Use of estrogen
* Calcitonin drugs
* Previous antidepressant or other psychiatric drug use or prior treatment history

Primary outcomes:
measure: bone mineral density (BMD)
timeFrame: Change from Baseline in bone mineral density at one year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: World Health Organization
name: yiming wang, Ph.D
role: STUDY_CHAIR
References:
Clinical trial NCT04038268: Criteria Used by Health Professionals on the Selection of Allergen Immunotherapy in Real Clinical Practice
Official title: Criteria Used by Health Professionals on the Selection of Allergen Immunotherapy in Real Clinical Practice: an International E-survey
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Allergen Immunotherapy
Keywords: Immunotherapy
Real Clinical Practice
Respiratory disease
Aeroallergens
IgE-dependent hypersensitivity
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2019-07-30
Enrollment: 400
Sex: ALL
Minimum age (years): 5
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with IgE mediated hypersensitivity to aeroallergens who will initiate AIT, either SCIT, SLIT-drops or SLIT-tablets according to real life clinical standards of practice

Brief summary: Background : Allergen Immunotherapy (AIT) is the only etiological treatment for allergic respiratory diseases. In order to improve the competence on the use of AIT, it is important to extend the investigator's knowledge on its use in routine clinical practice, outside the experimental setting of clinical trials, in real life population of patients receiving AIT.

Objective: To evaluate the clinical criteria used by treating clinicians and by the patients themselves, when establishing AIT as treatment in a patient with respiratory disease caused by an IgE-dependent-hypersensitivity to aeroallergens Methods: In 6 country (Denmark, France, Germany, Norway, Spain \& Sweden), the national coordinator will be directly responsible for selection of Survey Doctor's participants (Investigators).

During 12 months:

* Firstly, each investigator will complete the Survey Doctor, online, on SurveyMonkey platform to explain what are the key drivers in Allergen Immunotherapy (AIT) selection (Doctors' Questionnaire, DQ).
* On the other hand, at each AIT prescription to a patient, doctors will complete the Survey Patient, on the same platform, to explain how and why they have chosen this type of AIT (Patients' Questionnaire, PQ).


Eligibility criteria: Inclusion criteria:

* Patients with IgE mediated respiratory allergy
* Patients who will initiate any type of aeroallergen AIT according to real life clinical standards of practice
* Any type of aeroallergen for AIT will be included : pollen, house dust mite, animal, dander, moulds
* Patient who is under the care of the Doctor participating in the survey

Exclusion criteria:

* Patients who refuse to give their informed consent
* Food immunotherapy
* Venom Immunotherapy

Primary outcomes:
measure: Clinical criteria in AIT
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Montpellier
country: France
facility: Uhmontpellier
Study officials:
affiliation: University Hospital, Montpellier
name: Pascal Demoly
role: PRINCIPAL_INVESTIGATOR
References: