louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05870657: Adherence and Persistence to Inclisiran Among Early Users in Germany
Official title: Adherence and Persistence to Inclisiran Among Early Users in Germany
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: High Levels of Low-density Lipoprotein Cholesterol
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2023-05-23
Enrollment: 1109
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: This was a retrospective, noninterventional cohort study

Brief summary: The present study was a descriptive, non-interventional, retrospective cohort study aimed at evaluating early data on adherence, persistence, and treatment patterns among patients receiving inclisiran and other lipid-lowering therapies (LLT) in a real-world setting in Germany. Analysis was carried out using the IQVIA™ LRx database.


Eligibility criteria: Inclusion Criteria:

* Study subjects ≥18 years old who were prescribed an inclisiran dose.

Exclusion Criteria:

None

Primary outcomes:
measure: Number and percentage of patients with at least 5 months of potential follow-up who were prescribed a second dose of inclisiran
timeFrame: 8 months
measure: Percentage of patients who were prescribed a second dose of inclisiran between 1 and 6 months after prescription of first dose
timeFrame: 8 months
measure: Median time between first and second prescribed doses
timeFrame: 8 months
Secondary outcomes:
measure: Age and gender characteristics
timeFrame: 6 months
measure: Age and gender distribution
timeFrame: 6 months
measure: Prescriber specialty distribution for patients
timeFrame: 6 months
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: Novartis
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References:
Clinical trial NCT04972357: Bariatric Procedures and Changes Gastric Passage
Official title: Bariatric Procedures and Changes in Gut Hormone and Gastric Passage
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Gastric Emptying
Roux-en-Y Gastric Bypass
Bariatric Surgery
Lead sponsor: Rijnstate Hospital
Sponsor class: OTHER
First posted: 2021-07-22
Enrollment: 15
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Female patients who inderwent S-RYGB, B-RYGB or E-RYGB as a primary bariatric surgery.

Brief summary: Gastric emptying measured with scintigraphy in patients after standard Roux-en-Y Gastric Bypass (S-RYGB), Banded-RYGB (B-RYGB) or Extended pouch-RYGB (E-RYGB).


Eligibility criteria: Inclusion Criteria:

Female patients who underwent S-RYGB, B-RYGB or E-RYGB as a primary bariatric surgery.

Exclusion Criteria:

(1) had a disease known to affect appetite, gastric emptying or gastrointestinal motility (e.g., diabetes mellitus or hyper-/hypothyroidism); (2) were unable to stop medications that affect gastric emptying and/or motility three days prior to measurements (e.g., anti-cholinergic drugs, prokinetics, theophylline, calcium blocking agents, opioids); (3) started menopause; (4) were pregnant or lactating; (5) had a drug or alcohol addiction; (6) were unable to stop smoking for 24 hours.

Primary outcomes:
measure: Gastric emptying rate
timeFrame: cross-sectional study. Measured once over a period of 45-60 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Arnhem
country: Netherlands
facility: Rijnstate Hospital
Study officials:
References:
Clinical trial NCT03625557: Guardant360® Test-Related Clinical Outcomes in Patients Who Share Medical Records
Official title: Guardant360® Test-Related Clinical Outcomes in Patients Who Share Medical Records (GRECO)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Non-Hematologic Malignancy
Keywords: Guardant Health
GRECO
Lead sponsor: Guardant Health, Inc.
Sponsor class: INDUSTRY
First posted: 2018-08-10
Enrollment: 30
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: Participants with advanced cancer involving genetic pathway alterations identified through Guardant 360®.

Brief summary: To document the clinical outcomes of cancer patients who received the Guardant360® test and agree to share their records with Guardant Health.

Detailed description: This is an observational study of clinical outcomes to be conducted in the United States. Patients with a diagnosis of Stage 3-4 advanced cancer who possess specific pathway mutations identified by the Guardant360® test will be eligible to enroll in the study. Patients will be recruited by telephone or email and/or through the Guardant Health Patient Portal to determine interest in the study. Should patients be interested in contributing to this registry study, they will be prompted to consent via a commercial service for patients to request, manage, and view their medical records. Enrolled participants will be requested to release copies of their medical records for review by the principal investigator. Study adminsitrators will abstract participant demographics, cancer-related therapies, and clinical outcomes for analysis.

Eligibility criteria: General Inclusion Criteria:

* Adults (≥ 18 years old) with a diagnosis of Stage 3 or Stage 4 cancer (non-hematologic malignancy). Patients with advanced cancers not typically staged 1-4 (such as extensive stage small lung cancer) may be enrolled.
* Results from Guardant360® test
* Patient has previously provided contact information (either email or phone) to Guardant Health.
* Able and wiling to complete the informed consent process.
* Willingness to consent to the release of medical records.
* Willingness to provide Medical Records Release

General Exclusion Criteria:

* Unwilling or unable to provide written informed consent.
* Unable to understand English.
* Diagnosis of NSCLC
* Guardant 360® test results released to the patient's physician no less than 14 days and no greater than 60 days prior to initial patient contact.

Primary outcomes:
measure: Objective response rate (ORR)
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Redwood City
country: United States
facility: Guardant Health
state: California
Study officials:
affiliation: Guardant Health, Inc.
name: Kathryn Lang, MBBS, MRCP, FRCPath
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02378857: Fontan Circulation and Cardiopulmonary Function: Prognostic Factors, Hemodynamics and Long-term Effects
Official title: Fontan Circulation and Cardiopulmonary Function: Prognostic Factors, Hemodynamics and Long-term Effects
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Congenital Heart Disease
Keywords: Univentricular heart defect
Fontan circulation
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
Collaborators: name: The Hospital for Sick Children
First posted: 2015-03-04
Enrollment: 76
Sex: ALL
Minimum age (years): 15
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All adolescents i Norway with univentricular heart defects and Fontan type palliation

Brief summary: Cross-sectional study of a national cohort of adolescents with univentricular congenital heart defects and Fontan type palliation.

Detailed description: A study group of 40-50 individuals will be investigated by non-invasive and invasive methods, including echocardiography at rest and during exercise, heart catheterization with advanced hemodynamic studies, cardiac and abdominal MRI, abdominal ultrasound and transient elastography, quality of life assessment and cardiopulmonary exercise testing. A selection of tests will be performed in a healthy control group as well.

Eligibility criteria: Inclusion Criteria:

* age, heart defect, heart surgery and type of palliation/correction, informed consent

Exclusion Criteria:

* non-consenting, contraindications or increased risk to perform study tests (i.e. metal parts prohibiting MRI, motoric impairment prohibiting CPET)

Primary outcomes:
measure: Hemodynamic status
timeFrame: Current at time of inclusion
measure: Structural and functional hepatic changes
timeFrame: Current at time of inclusion
measure: Cardio-pulmonary function and functional reserve
timeFrame: Current at time of inclusion
measure: Quality of life and psycho-social outcome
timeFrame: Current at time of inclusion
Secondary outcomes:
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Oslo University Hospital, Rikshospitalet, Department of Paediatric Cardiology
Study officials:
affiliation: Oslo University Hospital, University of Oslo
name: Thomas Moller, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Moller T, Klungerbo V, Diab S, Holmstrom H, Edvardsen E, Grindheim G, Brun H, Thaulow E, Kohn-Luque A, Rosner A, Dohlen G. Circulatory Response to Rapid Volume Expansion and Cardiorespiratory Fitness in Fontan Circulation. Pediatr Cardiol. 2022 Apr;43(4):903-913. doi: 10.1007/s00246-021-02802-y. Epub 2021 Dec 17.
Clinical trial NCT06999057: Quadriceps Motor Unit Adaptation to Simulated Knee Injury
Official title: Quadriceps Motor Unit Adaptation to Simulated Knee Injury
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Muscle Inhibition
Knee Injury Simulation
Keywords: Quadriceps
Electromyography
Motor Unit
Knee Effusion
Lidocaine
Deafferentation
Neuromuscular Adaptation
Muscle Strength
Lead sponsor: University of Central Florida
Sponsor class: OTHER
First posted: 2025-05-31
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel Assignment
Primary purpose: BASIC_SCIENCE

Brief summary: This study investigates how simulated knee injury-via artificial joint effusion or deafferentation-affects quadriceps motor unit behavior in healthy young adults. Participants will complete neuromuscular testing during a single 2-hour lab session. This research seeks to improve understanding of muscle inhibition and inform interventions after real-world knee trauma.

Detailed description: Using a controlled laboratory model, the investigators will simulate knee injury through two methods: (1) intra-articular saline injection to induce effusion, and (2) intra-articular lidocaine injection to induce sensory deafferentation. Healthy participants aged 18-30 will undergo surface and decomposition EMG, isometric strength testing, and reflex measurements before and after the intervention. The primary outcome is motor unit recruitment characteristics, with secondary outcomes including quadriceps inhibition (Hoffmann reflex) and isometric peak torque. The findings will inform future neuromodulatory approaches in rehabilitation.

Eligibility criteria: Inclusion Criteria:

1. Age 18-30 years
2. Physically active (Tegner ≥ 5)
3. No prior lower-limb surgery or major injury

Exclusion Criteria:

1. Lower limb surgery or significant injury in past 2 years
2. Cardiopulmonary, neurological, or psychiatric disorders
3. Needle/electrical stimulation anxiety
4. Medications affecting neuromuscular or psychological function
5. Pregnancy
6. Allergic to lidocaine
7. Inability to elicit Hoffmann reflex

Primary outcomes:
measure: Motor Unit Recruitment (amplitude relative to recruitment threshold)
timeFrame: Baseline, 0, 30, and 60 minutes post-intervention
measure: Motor Unit Recruitment (firing rate relative to recruitment threshold)
timeFrame: Baseline, 0, 30, and 60 minutes post-intervention
Secondary outcomes:
measure: Quadriceps Inhibition (Hoffmann Reflex)
timeFrame: Baseline, 0 and 60 minutes post-intervention
measure: Isometric Peak Torque (Quadriceps Strength)
timeFrame: Baseline and 60 minutes post-intervention
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04610957: Effect of Adding Isoflavonoids to Clomiphene Citrate for Ovulation Induction in Women With Polycystic Ovary Syndrome
Official title: Effect of Adding Isoflavonoids to Clomiphene Citrate for Ovulation Induction in Women With Polycystic Ovary Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ovulation Induction
Polycystic Ovary Syndrome
Keywords: Human chorionic gonadotropin
clomiphene Citrate
Isoflavonoids
polycystic ovary syndrome
Lead sponsor: Zagazig University
Sponsor class: OTHER_GOV
First posted: 2020-11-02
Enrollment: 160
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This prospective, randomized clinical trial double blinded study, has been carried on 160 infertile patients seeking pregnancy in Gynecology and Obstetrics Department, Zagazig University Hospitals during the period from January 2019 to November 2019, the participants' randomizations were done and patients divided into two groups; group I: included 80 women receiving Clomiphene citrate (CC) plus Isoflavonoids. Group 2: included 80 women receiving Clomiphene citrate only

Detailed description: Phytoestrogens continue to be of increasing interest because of their possible influence on the physiology of the reproductive tract.

The aim of Prospective randomized clinical trial study is to evaluate effect of adding isoflavonoids to clomiphene citrate during ovulation induction in women with PCOS on the endometrial thickness which has an impact on pregnancy rate.

This study included 160 infertile women seeking pregnancy and they were divided into two groups. Clomiphene is given orally at dose, one tablet twice per day (tablet 50 mg), from day 3 to day 7 for all patients (group I and group II),while phytoestrogens are given at dose, two tablets two times per day (tablet 800mg), from day 3 to day 12 only for group I, followed by HCG injection on attaining mature follicle(s) by trans-vaginal US scan with diameter ≥ 18 mm.

Eligibility criteria: Inclusion Criteria:

• Patient aged 18- 35 years old with primary or secondary infertility

Exclusion Criteria:

* Patient aged 18- 35 years old with primary or secondary infertility
* Patient whose husband has a male factor of infertility.
* Hepatic, renal, diabetic, thyroid or cardiovascular disorders.
* Organic pelvic disease (uterine fibroids or ovarian cysts).
* Abnormality detected by HSG as blocked tubes

Primary outcomes:
measure: Clinical pregnancy rate
timeFrame: up to 24 weeks
Secondary outcomes:
measure: Endometrial thickness,
timeFrame: up to 24 weeks
measure: ovulation rate
timeFrame: up to 24 weeks
Other outcomes:
Locations:
city: Zagazig
country: Egypt
facility: Faculty of Medicine
state: Sharkia
Study officials:
References:
Clinical trial NCT00825357: Biological Markers to Identify Early Sepsis and Acute Lung Injury
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sepsis
Acute Lung Injury
Keywords: biological markers
sepsis
acute lung injury
Lead sponsor: Chimei Medical Center
Sponsor class: OTHER
First posted: 2009-01-21
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients admitted to ICU and age ≧18-year-old.

Brief summary: There are no clear markers to identify sepsis and acute lung injury at early stage in clinical settings which would result in improved survival of the patients. In collaboration with the research team led by Dr. Zhang at St. Michael's Hospital, Toronto, we have initiated a pilot study looking for biological markers to detect severe sepsis and ARDS. We have found that human neutrophils peptides (a-defensins), certain coagulation variables and cytokine levels are very sensitive markers to differentiate severe sepsis, ARDS from cardiovascular diseases in ICU patients. These findings may provide valuable information for therapeutic guideline in clinical practice. The present study will focus on testing 'biological markers' to identify patients with sepsis and acute lung injury. We will examine the roles of three components of markers including inflammation, neutrophil activation and coagulation. We are hoping that this proposed translational research will help develop novel therapeutic strategy in sepsis and acute lung injury patients.


Eligibility criteria: Inclusion Criteria:

* Meet diagnostic criteria of ≧2 SIRS or acute lung injury.
* Get agreement of patient's attending physician and inform consent form patient or family.

Exclusion Criteria:

* Use Antibiotics over 24 hrs（only SIRS group）.
* Active bleeding.
* Pregnancy.
* Active Cancer (refer to malignancy which is recently diagnosed, under treatment, or relapsed)
* VS or Subject or Family refuse

Primary outcomes:
measure: The present study will focus on testing 'biological markers' to identify patients with sepsis and acute lung injury in early stage.
timeFrame: 72 hrs
Secondary outcomes:
Other outcomes:
Locations:
city: Tainan
country: Taiwan
facility: Department of Intensive Care Medicine; Chi Mei Medical Center
Study officials:
References:
Clinical trial NCT02911857: An Extention Study of Safety of Canakinumab in Japanese Patients With Periodic Fever Syndromes
Official title: An Extension Study of CACZ885N2301 (NCT02059291), Multi-center, Open Label Study of Canakinumab in Japanese Patients With Periodic Fever Syndromes (Tumor Necrosis Factor Receptor Associated Periodic Syndrome (TRAPS), Hyper Immunoglobulin D Syndrome ((Also Known as Mevalonate Kinase Deficiency) (HIDS/MKD), or Colchicine Resistant/Intolerant Familial Mediterranean Fever (crFMF))
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Periodic Fevers Syndrome
Keywords: Canakinumab,
interleukin-1
Periodic Fevers Syndrome
TRAPS
HIDS
crFMF
auto-inflammatory diseases
extension study
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2016-09-22
Enrollment: 4
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The primary objective of this study was to evaluate safety and tolerability of ACZ885 in this extension study. This extension study offered the opportunity for participants who completed Epoch 4 of the preceding CACZ885N2301 (NCT02059291) study to continue to be treated with ACZ885 until approval in Japan of the drug in Periodic Fever Syndromes or until development of ACZ885 in Periodic Fever Syndromes was suspended.


Eligibility criteria: Inclusion Criteria:

* Completed Epoch 4 of the CACZ885N2301 study in Japan before the approval of canakinumab in Japan
* Written informed consent. Parent or legal guardian's written informed consent and child's assent, if appropriate, are required before any assessment is performed for patients \< 20 years of age

Exclusion Criteria:

* Any conditions or significant medical problems in which the investigator judges the patient should not enter this extension study

Primary outcomes:
measure: Number of Participants With Non-serious Adverse Events, Serious Adverse Events and Deaths
timeFrame: Participants were followed for the duration until approval, an expected average of 3 months.
Secondary outcomes:
Other outcomes:
Locations:
city: Fukuoka city
country: Japan
facility: Novartis Investigative Site
state: Fukuoka
city: Yokohama-city
country: Japan
facility: Novartis Investigative Site
state: Kanagawa
city: Kyoto-city
country: Japan
facility: Novartis Investigative Site
state: Kyoto
Study officials:
References:
Clinical trial NCT02026557: Mortality Among Children With Congenital Heart Defects in Norway
Official title: Mortality Among Children With Congenital Heart Defects in Norway
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Congenital Heart Disease
Lead sponsor: Sorlandet Hospital HF
Sponsor class: OTHER_GOV
Collaborators: name: University of Oslo
name: University of Bergen
name: Oslo University Hospital
First posted: 2014-01-03
Enrollment: 15000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Oslo University hospital´s registry of patients with congenital heart diseases

Brief summary: To describe mortality among children with congenital heart defects in Norway


Eligibility criteria: Inclusion Criteria:

* children with congenital heart defects

Exclusion Criteria:

* no

Primary outcomes:
measure: Number of death until 31 dec 2012 among Norwegian children with congenital heart defects born 1994-2009
timeFrame: 31.12.2010
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Sorlandet Hospital
name: Jarle Jortveit, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Jortveit J, Leirgul E, Eskedal L, Greve G, Fomina T, Dohlen G, Tell GS, Birkeland S, Oyen N, Holmstrom H. Mortality and complications in 3495 children with isolated ventricular septal defects. Arch Dis Child. 2016 Sep;101(9):808-13. doi: 10.1136/archdischild-2015-310154. Epub 2016 Apr 18.
Clinical trial NCT03756857: Does the Embryo Transfer Technique Affect the Success of in Vitro Fertilization?
Official title: Comparison of IVF Success Rates Between Different Embryo Transfer Techniques: Afterload Technique and Trial Followed by Transfer Technique
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Infertility
Assisted Reproductive Technology
IVF
Lead sponsor: Acibadem Kadiköy Hospital
Sponsor class: OTHER
First posted: 2018-11-28
Enrollment: 200
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 37
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective, open, randomized, parallel, two-arm trial
Primary purpose: TREATMENT

Brief summary: Prospective, open, randomized, parallel, two-arm trial to compare the clinical pregnancy rate between most commonly used two embryo transfer techniques: trial followed by transfer technique and afterloading technique

Detailed description: Eligible patients will be informed about the possibility of participating in the clinical trial in the beginning of treatment and on the day ET, a signed consent form will be collected from those recipients who confirmed their participation. These patients will be randomized immediately before the ET procedure by sequentially numbered, opaque, sealed envelopes

Eligibility criteria: Inclusion Criteria:

1. Patient has given written informed consent
2. BMI 18-30 kg/m2
3. \< 2 previous failed IVF trials
4. At least two good quality embryos on the day of transfer

Exclusion Criteria:

1. Congenital uterine anomaly
2. Untreated endometrial polyp or fibroid distorting uterine cavity
3. Presence of hydrosalpinx 4.2 or more prior IVF trial failure

5.Moderate to severe endometriosis 6.Recurrent pregnancy loss history

Primary outcomes:
measure: clinical pregnancy rate
timeFrame: 5-6 weeks after embryo transfer
Secondary outcomes:
measure: implantation rate
timeFrame: 3-4 weeks after embryo transfer
Other outcomes:
Locations:
city: İstanbul
country: Turkey
facility: Acibadem Altunizade Hospital, Unit of ART
Study officials:
References: