louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06948383: SPSIPB vs. SAPB in Breast Surgery
Official title: Serratus Posterior Superior Intercostal Plane Block Versus Serratus Anterior Plane Block for Breast Surgery: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Postoperative Pain
Quality of Recovery
Keywords: postoperative pain
pain scores
Pain management
Fasial plane blocks
Lead sponsor: Zonguldak Bulent Ecevit University
Sponsor class: OTHER
First posted: 2025-04-29
Enrollment: 90
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The effects of the newly defined serratus posterior superior intercostal plane block and serratus anterior plane block on postoperative analgesia and quality of recovery in women undergoing breast surgery will be investigated.


Eligibility criteria: Inclusion Criteria:

* Patients who have received informed consent form Patients who will undergo Breast Cancer Surgery aged between 18-65

Exclusion Criteria:

* \<18 years and \>65 years
* ASA ≥ IV
* History of allergy to local anesthetics
* Clinical diagnosis of coagulation disorders
* Infection near the entry site
* Chronic analgesic use Patients who will undergo bilateral Breast Cancer Surgery
* Body mass index \>35
* Clinical diagnosis of Dementia or confusion
* Lack of cooperation

Primary outcomes:
measure: postoperative opioid consumption
timeFrame: up to 24 hour after surgery
Secondary outcomes:
measure: Postoperative pain scores
timeFrame: postoperative 2nd 6th, 12th 24th hour
measure: quality of recovery
timeFrame: postoperative 24 hour
Other outcomes:
Locations:
city: Zonguldak
country: Turkey
facility: Zonguldak Bülent Ecevit University Medicine Faculty
state: Kozlu
Study officials:
References:
Clinical trial NCT01550861: In Vitro Maturation (IVM) of Human Oocytes
Official title: In Vitro Maturation (IVM) of Human Oocytes
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Infertility
Keywords: infertility
in vitro maturation (IVM)
in vitro fertilization (IVF)
natural cycle
Lead sponsor: Weill Medical College of Cornell University
Sponsor class: OTHER
First posted: 2012-03-12
Enrollment: 2
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 42
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The objectives of this study are to evaluate the clinical efficacy of Natural in vitro Fertilization and in vitro maturation.

Detailed description: Collection of one mature egg from a follicle in the ovary without gonadotropin medications (natural cycle IVF) results in low pregnancy rates. One way to improve natural cycle IVF is to combine this procedure with the removal of immature eggs from the ovary and mature these eggs in the laboratory ( in vitro maturation-IVM). The in vitro mature eggs are fertilized and the resultant embryos are cultured using conventional IVF techniques.

Eligibility criteria: Inclusion Criteria:

1. Each subject must be female.
2. Each subject must have an indication for COH and IVF with or without ICSI.
3. Each subject must be willing and able to provide written informed consent for the trial
4. Each subject must be 25 to ≤42 years of age at the time of signing informed consent.
5. Each subject must have a normal cervical smear result (no atypical or abnormal cells, or in case of atypical squamous or glandular cells, no signs of malignancy; corresponding to Papanicolaou \[PAP\] I or II) obtained within 12 months prior to signing informed consent must be available

Exclusion Criteria:

1. Subject with premature ovarian failure
2. Subject with endocrine abnormalities such as hyperprolactinaemia or thyroid dysfunction
3. Subject with malformation or absence of uterus
4. Subject has tested positive for Human Immunodeficiency Virus (HIV) or Hepatitis B (by local laboratory; results obtained within 1 year prior to signing ICF are considered valid).
5. Subject with contraindication or allergy/hypersensitivity to hCG, estrogen and progesterone

Primary outcomes:
measure: number of oocytes retrieved and embryos generated
timeFrame: 1 year
Secondary outcomes:
measure: live birth rate
timeFrame: 1 year
Other outcomes:
Locations:
city: New York
country: United States
facility: Center for Reproductive Medicine- Weill Cornell Medical College
state: New York
Study officials:
affiliation: Weill Cornell
name: Zev Rosenwaks, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04041661: Concurrent Transcranial Direct Current Stimulation and Gait Training in Parkinson's Disease
Official title: The Effect of Concurrent Transcranial Direct Current Stimulation and Gait Training on Gait Performance When Doing the Cognitive Dual-task in People With Parkinson's Disease
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Parkinson's Disease
Keywords: Dual task performance
Executive function
Transcrainal direct current stimulation (tDCS)
Lead sponsor: National Yang Ming Chiao Tung University
Sponsor class: OTHER
First posted: 2019-08-01
Enrollment: 30
Sex: ALL
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To investigate the effect of concurrent transcranial direct current stimulation and gait training on gait performance when doing the cognitive dual-task in people with Parkinson's Disease.


Eligibility criteria: Inclusion Criteria:

* Diagnosed with idiopathic PD
* Hoehn and Yahr stages I-III
* Mini Mental Status Examination (MMSE) score ≧ 24
* Could walk 10m independently with or without gait aid

Exclusion Criteria:

* Concurrent medication likely to affect mental performance
* tDCS contraindication
* Significant neurological, vestibular, visual disorders or psychiatric illness
* Musculoskeletal or cardiopulmonary disease
* Sensory system pathology

Primary outcomes:
measure: Dual-task walking performance
timeFrame: Change from baseline at 4 weeks
Secondary outcomes:
measure: Single walking performance
timeFrame: Change from baseline at 4 weeks
measure: Trail-making test A & B
timeFrame: Change from baseline at 4 weeks
measure: Stroop color and word test-Chinese version
timeFrame: Change from baseline at 4 weeks
measure: Digit span test
timeFrame: Change from baseline at 4 weeks
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05878561: A Study to Evaluate the Efficacy and Safety of BR1015 Combination Therapy
Official title: A Randomized, Double-blind, Multicenter, Phase III Study to Evaluate the Efficacy and Safety of BR1015 Combination Therapy in Comparison With Fimasartan Monotherapy for Essential Hypertension Patients Not Adequately Responded by Fimasartan 30 mg
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Essential Hypertension
Lead sponsor: Boryung Pharmaceutical Co., Ltd
Sponsor class: INDUSTRY
First posted: 2023-05-26
Enrollment: 248
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The objective of this clinical trial is to evaluate the efficacy and safety of BR1015 Combination therapy group in comparison with Fimasartan monotherapy group at Week 8 for essential hypertension patients who do not adequately responded by Fimasartan 30 mg


Eligibility criteria: * Inclusion Criteria:

  * Patients with uncontrolled essential hypertension at screening(V1) under the following criteria:

    * Naïve : 140 mmHg ≤ SiSBP \< 180 mmHg
    * Use antihypertensive drugs : 130 mmHg ≤ SiSBP \< 180 mmHg
  * Patients with uncontrolled essential hypertension at randomization(V2) after Fimasartan 30mg monotherapy for 4 weeks under the following criteria:

    * Selected reference arm : 140 mmHg ≤ SiSBP \< 180 mmHg (For patients with cardiovascular disease, diabetes or chronic kidney disease (CKD) with albuminuria, 130 mmHg ≤ SiSBP \< 180 mmHg)
    * Treatment compliance of Fimasartan 30 mg ≥70% at baseline visit (V2)
  * Voluntarily provided a written consent to participate in this clinical study
  * Able to understand this study, be cooperative in the execution of the study, and participate in the study until its completion
* Exclusion Criteria:

  * Patients taking three or more antihypertensive drugs of different families
  * Patients with blood pressure results showing SiSBP ≥ 180 mmHg or SiDBP ≥ 110 mmHg in the selected reference arm at screening(V1) and randomization(V2)
  * Patients with a difference of SiSBP ≥ 20 mmHg and SiDBP ≥ 10 mmHg in blood pressure measured three times on both arms at screening(V1)
  * Patients with secondary hypertension: Secondary hypertension is not limited to the following diseases; (e.g., coarctation of the aorta, Primary hyperaldosteronism, renal artery stenosis, Cushing's syndrome, pheochromocytoma and polycystic kidney disease, etc.)
  * Patients with orthostatic hypotension accompanied by symptoms
  * Patients who need to be administered in combination with antihypertensive drugs other than investigational product while participating in clinical trials

Primary outcomes:
measure: Sitting systolic blood pressure
timeFrame: 8weeks from Baseline Visit
Secondary outcomes:
measure: Sitting systolic blood pressure
timeFrame: 4weeks from Baseline Visit
Other outcomes:
Locations:
city: Bucheon-si
country: Korea, Republic of
facility: The Catholic University of Korea, Bucheon St.Mary's Hospital
state: Kyunggi-do
Study officials:
References:
Clinical trial NCT00404261: Evaluation Of Patient Satisfaction Of Metered Dose Inhaler (MDI) With Counter In Asthmatics And Chronic Obstructive Pulmonary Disease Patients (COPD).
Official title: An Open Label, Multicentre Study to Evaluate Patient Satisfaction With Fluticasone/Salmeterol HFA MDI With Counter in Adult Subjects (18 Years of Age and Older) With Asthma or COPD.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Asthma
Keywords: Fluticasone Propionate
healthcare professional satisfaction
patient satisfaction
metered dose inhaler with counter
Salmeterol
Chronic Obstructive Pulmonary Disease (COPD)
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2006-11-28
Enrollment: 132
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: The purpose of this study is to evaluate the level of satisfaction experienced by asthma or chronic obstructive pulmonary disease (COPD) patients when using the Fluticasone/Salmeterol HFA Metered Dose Inhaler (MDI) with counter, as compared to using Fluticasone/Salmeterol HFA MDI without counter.


Eligibility criteria: Inclusion Criteria:

* Outpatient
* Documented physician diagnosis of asthma or COPD
* Requires use of a controller and long acting beta 2 agonist
* Ability to provided written informed consent

Exclusion Criteria:

* Patients with life threatening asthma or COPD
* Historical or current evidence of significant diseases
* Immediate or delayed hypersensitivity to inhaled short acting beta2agonist or sympathomimetic drug or any component of the MDI formulation
* History of drug or alcohol abuse Abnormal chest x ray not consistent with asthma or COPD
* Use of supplemental oxygen; systemic corticosteroids; short acting beta2agonists other than VENTOLIN HFA; antibiotics for respiratory infections; anti-arrhythmics; anticonvulsants; central nervous system stimulants; tricyclic antidepressants and monoamine oxidase inhibitors.

Primary outcomes:
measure: Patient satisfaction questionnaires administered at baseline and at the end of treatment (day 30).
timeFrame: Day 30
Secondary outcomes:
measure: Healthcare professional satisfaction questionnaires administered at baseline and at the end of treatment (day 30) Patient compliance as measured by the device counter readings at the end of treatment (day 30), compared to the baseline reading.
timeFrame: Day 30
measure: Healthcare professional satisfaction questionnaires Patient Compliance Safety Evaluations: adverse events
timeFrame: 8 months
Other outcomes:
Locations:
city: Auchenflower
country: Australia
facility: GSK Investigational Site
state: Queensland
city: Caboolture
country: Australia
facility: GSK Investigational Site
state: Queensland
city: Kippa Ring
country: Australia
facility: GSK Investigational Site
state: Queensland
city: Perth
country: Australia
facility: GSK Investigational Site
state: Western Australia
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT05909761: Observational Safety Study in Women With Neuromyelitis Optica Spectrum Disorder (NMOSD) Exposed to UPLIZNA® During Pregnancy
Official title: An Observational Pregnancy Safety Study in Women With Neuromyelitis Optica Spectrum Disorder (NMOSD) Exposed to UPLIZNA® (Inebilizumab-cdon) During Pregnancy
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Neuromyelitis Optica Spectrum Disorder
Pregnancy Related
Keywords: Neuromyelitis Optica Spectrum Disorder
Pregnancy
UPLIZNA
inebilizumab
birth complications
Lead sponsor: Amgen
Sponsor class: INDUSTRY
First posted: 2023-06-18
Enrollment: 60
Sex: FEMALE
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population will consist of participants who have been exposed to UPLIZNA during pregnancy and have signed an informed consent form (ICF).

Brief summary: This is an observational study to monitor female participants exposed to UPLIZNA during pregnancy. This study requires voluntary reporting of pregnancies in female participants with NMOSD exposed to UPLIZNA during pregnancy or within 6 months preceding conception. Pregnancy-related data, potential confounding factors and information related to pregnancy outcome will be collected. The schedule of office visits and all treatment regimens will be determined by the treating healthcare provider. Duration of the study is 10 years, at minimum.

Detailed description: Acquired from Horizon in 2024.

Eligibility criteria: Inclusion Criteria:

* Provide informed consent
* Are a female of reproductive potential with a confirmed or suspected diagnosis of NMOSD
* Have been exposed to UPLIZNA during pregnancy as defined by receipt of any dose during pregnancy or within 6 months preceding conception

Note: Other Protocol Defined Inclusion/Exclusion Criteria Apply

Primary outcomes:
measure: Number of newborns with Major Congenital Malformations (MCMs)
timeFrame: Minimum of 10 years
measure: Number of newborns with Preterm birth
timeFrame: Minimum of 10 years
measure: Number of newborns with low birth weight
timeFrame: Minimum of 10 years
measure: Number of stillbirths
timeFrame: Minimum of 10 years
Secondary outcomes:
measure: Number of newborns with Minor Congenital Malformations
timeFrame: Minimum of 10 years
measure: Number of infants with developmental milestone abnormalities
timeFrame: Minimum of 10 years
measure: Number of infants with neurologic abnormalities
timeFrame: Minimum of 10 years
measure: Number of infants with immune system development abnormalities
timeFrame: Minimum of 10 years
measure: Number of Spontaneous Abortions
timeFrame: Minimum of 10 years
measure: Number of Induced or Elective Abortions
timeFrame: Minimum of 10 years
Other outcomes:
Locations:
city: Aurora
country: United States
facility: University of Colorado Denver
state: Colorado
Study officials:
affiliation: Amgen
name: MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT03446183: Short Term Effect of Smoking Cessation on Human Metabolism
Official title: Short Term Effect of Smoking Cessation on Human Metabolism
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Smoking Cessation
Metabolic Syndrome
Lead sponsor: Hebrew University of Jerusalem
Sponsor class: OTHER
Collaborators: name: Meuhedet. Healthcare Organization
First posted: 2018-02-26
Enrollment: 308
Sex: ALL
Minimum age (years): 25
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Volunteers who were recruited from the smoking cessation workshops of the Meuhedet HMO (Israeli Health Services) during 2016-2017.

Brief summary: Investigating the short term smoking cessation on metabolism, examining of participant of smoking cessation workshops and former participants' file survey for metabolic aspects

Detailed description: Objective: To examine metabolic aspects occurring during the first 6-12 months following smoking cessation in participants of smoking cessation workshops.

Design: A two armed study: prospective and retrospective. Prospective: Weight, BMI, waist circumference and waist: hip ratio were measured before, during and 6 months post cessation program. Retrospective: Blood test data for Blood fasting glucose (BFG) and lipid profile from the year preceding the workshops and the year after them were analyzed from participants' files. Smoking status was verified by phone conversation.

Eligibility criteria: Inclusion Criteria:

* Volunteers who were recruited from the smoking cessation workshops of the Meuhedet HMO (Israeli Health Services) during 2016-2017.

Exclusion Criteria:

* Candidates with benign tumors, bariatric surgeries, and endoscopic bariatric procedures before or during the study period were excluded

Primary outcomes:
measure: Change in weight
timeFrame: 6 months from baseline
measure: Change in BMI
timeFrame: 6 months from baseline
measure: Change in waist and hip circumference
timeFrame: 6 months from baseline
measure: Change in Blood fasting glucose according to patient files (unspecified time points up to a year before and a year after the workshops)
timeFrame: up to 2 years from baseline
measure: Change in lipid profile according to patient files (unspecified time points up to a year before and a year after the workshops)
timeFrame: up to 2 years from baseline
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01028183: Impact of Maternal-infant Therapeutics on Safety, Mortality, and Disability
Official title: Impact of Maternal-infant Therapeutics on Safety, Mortality, and Disability
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Gastroesophageal Reflux
Presumed Sepsis
Patent Ductus Arteriosus
Chronic Lung Disease
Neurodevelopmental Impairment
Keywords: therapeutics
safety
maternal
neonatal
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2009-12-09
Enrollment: 0
Sex: ALL
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: We will enroll 10,000 infants at 40 centers. Infants will be enrolled into one of four strata: extremely premature (\<30 weeks, n=5,000), premature (30-36 weeks inclusive n=2,000), hospitalized term (≥37 weeks gestation, n=2,000), and healthy term (≥37 weeks gestation, n=1,000).

Brief summary: The purpose of this research is to address the comparative effectiveness and harm of the therapeutics frequently given to pregnant women and their young infants including antibiotics, tocolytic agents, non-steroidal anti-inflammatory drugs, H2 blockers, and steroids.

Our overall hypothesis is that the use of an existing electronic medical record with additional resources for precise data collection and 18 month follow up will successfully address current knowledge gaps in therapeutic effectiveness and relative therapeutic harm.

We will use an existing electronic medical record into which detailed healthcare information is entered for over 100,000 newborns each year. These infants will comprise the "Source Cohort". Nested within that database, we will prospectively enroll 10% of the population (10,000 newborns) as the Follow-Up Cohort.

The current electronic medical record for the Source Cohort does not capture therapeutic dosing with sufficient precision to conduct comparative effectiveness research sufficient to change medical practice. The proposed research will: 1) ensure accurate data collection through electronic monitoring and real-time quality assurance evaluation in the Source Cohort; and 2) conduct 18 months post-hospital follow-up for neurologic outcomes and disability for the Follow-Up Cohort. We will complete assessments of neurologic outcomes and disability using an interactive web-based system, mail, telephone follow up, and in-person examination.


Eligibility criteria: Inclusion Criteria:

* Admitted to the a Pediatrix Medical Group NICU
* \<=5 days of life
* likely to follow-up at 18 months adjusted age

Exclusion Criteria:

* failure to consent

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke Clinical Research Institute
state: North Carolina
Study officials:
affiliation: Duke Clinical Research Institute
name: Daniel K Benjamin, MD PhD MPH
role: PRINCIPAL_INVESTIGATOR
References: