louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02223299: Pilot Study: Combining Nutritional Supplements With Standard Antidepressant to Treat Depression.
Official title: A Randomized Double-Blind Placebo-Controlled Pilot Study of L-tyrosine and L-tryptophan in Depressed Patients Receiving L-methylfolate and and SSRI
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Depression
Keywords: Depression
SSRI
Nutritional Supplements
Beck Depression Scale
Lead sponsor: John D. Dingell VA Medical Center
Sponsor class: FED
First posted: 2014-08-22
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: \*\*This study never received IRB approval and no participants were ever enrolled\*\* The purpose of this study is to determine if adding over the counter nutritional supplements will have a benefit to participants currently taking prescribed antidepressants who have not experienced complete remission of their depression symptoms.

Detailed description: Inclusion Criteria:

Detroit VA Patients with major depression, mild to moderate treated with an SSRI and not having complete remission of symptoms as defined by "feeling their normal selves"

Randomized into two groups:

Experimental: will receive month supply of deplin 15mg, L-tyrosine 6g/d into 2 divided doses, and L-tryptophan 2g/d into 2 divided doses.

Control: will receive month supply of deplin 15mg , and 2 placebo pills.

Beck Depression Scale (BDI-2) to be administered at baseline and every 2 weeks for 1 month.

Eligibility criteria: \*\*This study never received IRB approval and no participants were enrolled\*\*

Inclusion Criteria:

* Veterans Administration Medical Center patients with major depression, mild to moderate treated with an SSRI and not having complete remission of symptoms.

Primary outcomes:
measure: Benefit of nutritional supplement
timeFrame: 30 days
Secondary outcomes:
Other outcomes:
Locations:
city: Detroit
country: United States
facility: John D Dingell VA Medical Center
state: Michigan
Study officials:
References:
Clinical trial NCT05651399: Comparison in Frequency of Hypotension Between Remimazolam and Propofol in Hip Surgery
Official title: Comparison in Frequency of Hypotension During Sedation of Propofol and Remimazolam in Spinal Anesthesia in Hip Surgery Patients: a Randomized Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Remimazolam
Propofol
Orthopedic Procedures
Sedatives
Anesthesia, Spinal
Lead sponsor: Asan Medical Center
Sponsor class: OTHER
First posted: 2022-12-15
Enrollment: 78
Sex: ALL
Minimum age (years): 20
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare the incidence of hypotension between remimazolam and propofol for intraoperative sedation in patients undergoing hip surgery with spinal anesthesia.


Eligibility criteria: Inclusion Criteria:

* ASA physical status 1-3
* Patients scheduled for hip joint surgery under spinal anesthesia and sedation with propofol or remimzolam

Exclusion Criteria:

* Patients who refuse to participate in this study
* Patients with uncontrolled high blood pressure, hyperthyroidism, dementia in the inability to communicate, or symptomatic coronary artery disease
* Patients with an allergy to propofol, fentanyl, or bupivacaine
* Patients contraindicated for spinal anesthesia, such as coagulopathy, severe aortic stenosis/mitral stenosis, and active infection on lumbar region
* Patients judged to be inappropriate for this study

Primary outcomes:
measure: Frequency of hypotension during surgery (1hour)
timeFrame: up to 1 hour after initiation of drug infusion
Secondary outcomes:
measure: Frequency of hypotension during surgery
timeFrame: Throughout the surgery
measure: Total administered phenylephrine
timeFrame: Throughout the surgery
measure: Fluid volume
timeFrame: Throughout the surgery
measure: Number of hypotensive episodes in the post-anesthesia care unit after surgery
timeFrame: up to 1 hour after postanesthesia care unit entry
measure: Complications after surgery
timeFrame: up to 7 days after surgery
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
Study officials:
References:
Clinical trial NCT01051999: Glutamine Supplementation in Cystic Fibrosis
Official title: Glutamine Supplementation and Immunity in Adults With Cystic Fibrosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Cystic Fibrosis
Immune Function
Keywords: Glutamine
Lead sponsor: Emory University
Sponsor class: OTHER
Collaborators: name: Emmaus Medical, Inc.
First posted: 2010-01-20
Enrollment: 17
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Patients with cystic fibrosis develop frequent and potentially life-threatening lung infections. Recent studies suggest that the nutrient "glutamine" may help the body fight off infection. Glutamine is an amino acid; a type of nutrient the body requires to build muscle. It is one of the building blocks of protein. During an illness, blood levels of glutamine tend to be lower than normal. Also, many patients with cystic fibrosis have difficulty getting normal levels of nutrients from food. The aim of this study is to see if patients with cystic fibrosis have low levels of glutamine when they experience an infection, and whether a dietary glutamine supplement taken daily for three months can raise these levels. We also want to see if this supplement can improve other blood markers of immunity (the body's ability to defend itself from infection). We hope to enroll 40 people with cystic fibrosis who experience a lung infection, over a one year period, into this study.


Eligibility criteria: Inclusion Criteria:

* Adult patients (≥ 18 years of age) with cystic fibrosis who give informed consent
* Patients must have a clinically diagnosed pulmonary exacerbation at time of enrollment, characterized by clinical requirement for oral or intravenous antibiotics associated with pulmonary symptoms such as increased cough or decreased forced expiratory volumes (FEV1)
* Participants must agree to provide phlebotomy samples and complete all study protocol at presentation and at return visits

Exclusion Criteria:

* Any patients taking specific glutamine supplements within 30 days of enrollment
* Pregnant or lactating women
* Patients involved in any other research protocol involving intake of a study drug, in the last 60 days.
* Patients who are chronically immunosuppressed due to drugs or immunosuppressive illness other than CF (e.g. HIV/AIDS, chronic autoimmune disease)
* Patients receiving hemodialysis or with creatinine \>2.5mg/dL
* Patients with liver failure from any cause
* Patients with a history of cancer within the past 12 months or currently receiving anti-neoplastic therapy.
* Patients with a history of seizures

Primary outcomes:
measure: Percent increase in plasma glutamine and glutathione redox levels measured at weeks 0, 4, 8, and 12.
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Emory University
state: Georgia
Study officials:
References:
Clinical trial NCT05146999: Assess Aesthetic Improvement and Onset of QM1114-DP in Subjects With Moderate to Severe Glabellar Lines
Official title: A Phase 3b, Randomized, Double-Blind, Placebo-Controlled Study to Assess Aesthetic Improvement and Onset of QM1114-DP Treatment Effect in Subjects With Moderate to Severe Glabellar Lines
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Glabellar Frown Lines
Lead sponsor: Galderma R&D
Sponsor class: INDUSTRY
First posted: 2021-12-07
Enrollment: 132
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel assignment
Primary purpose: TREATMENT

Brief summary: The objective of this study is to evaluate the aesthetic improvement and onset of QM1114-DP treatment for subjects with moderate to severe glabellar lines


Eligibility criteria: Inclusion Criteria:

* Male or Female 18 years or older
* Moderate to severe GL at maximum frown as assessed by the Investigator
* Moderate to severe GL at maximum frown as assessed by the subject

Exclusion Criteria:

* Previous use of any botulinum toxin in facial areas within 9 months prior to study treatment
* Female who is pregnant, breast feeding or intends to conceive a child during the study.

Primary outcomes:
measure: Number of Responders Using the Global Aesthetic Improvement Scale (GAIS) at Month 1
timeFrame: At Month 1
Secondary outcomes:
measure: Percentage of Participants Reporting Onset of Treatment Effect Using the Diary Card
timeFrame: At Days 0 through 7 post-treatment
measure: Number of Responders Using the Global Aesthetic Improvement Scale (GAIS) From Day 1 Through Month 12
timeFrame: From Day 1 through Month 12
Other outcomes:
Locations:
city: Homewood
country: United States
facility: Galderma Research Site
state: Alabama
city: Manhattan Beach
country: United States
facility: Galderma Research Site
state: California
city: Vista
country: United States
facility: Galderma Research Site
state: California
city: Coral Gables
country: United States
facility: Galderma Research Site
state: Florida
city: Hunt Valley
country: United States
facility: Galderma Research Site
state: Maryland
city: Omaha
country: United States
facility: Galderma Research Site
state: Nebraska
city: Chapel Hill
country: United States
facility: Galderma Research Site
state: North Carolina
city: Pflugerville
country: United States
facility: Galderma Research Site
state: Texas
city: Spring
country: United States
facility: Galderma Research Site
state: Texas
Study officials:
References:
Clinical trial NCT04905199: Temporary Transvenous Pacemaker Placement by Intracavitary Electrocardiogram Monitoring
Official title: Bedside Precise Temporary Transvenous Cardiac Pacemaker Placement by Intracavitary Electrocardiogram Monitoring
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Bradycardia; Syncope
Bradyarrhythmia
Brady-tachy Syndrome
Tachycardia Bradycardia
AVB - Atrioventricular Block
Tachyarrhythmia
Lead sponsor: Hunan Provincial People's Hospital
Sponsor class: OTHER
First posted: 2021-05-27
Enrollment: 60
Sex: ALL
Minimum age (years): 14
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients need emergency or selective temporary pacing.

Brief summary: Traditional temporary pacing catheter insertion by intracavitary electrocardiogram (IC-ECG) monitoring which only monitoring tip polar, the negative one. The investigators modified the technique by monitoring both negative and positive polar which will be precisely locating catheter tip and indicating the direction of the catheter tip.

Extensively used temporary pacing catheter tip has two electrodes which are about 1 cm apart. Distal electrode is negative (-) and active, proximal electrode is positive (+) and indifferent.

Investigators use both distal (-) and proximal (+) electrodes which can be attached to any two of the V leads, record as V(-) and V(+). Monitoring positions of the electrodes by V(-) and V(+) could provide more information about the tip position. Comparing the QRS amplitudes between V(-) and V(+), when catheter tip enters right ventricle chamber: the case of V(-) \> V(+) infers tip toward apex ventricle wall ; conversely, the case of V(-)\<V(+) indicates tip directs to outflow tract.

The investigators hypothesis this monitoring will help precisely placement.


Eligibility criteria: Inclusion Criteria:

* Patients with indication of temporary transvenous pacing

Exclusion Criteria:

* Not applicate to IC-ECG monitoring.

Primary outcomes:
measure: Pacer leads location
timeFrame: One day.
measure: Catheter-related complications
timeFrame: One month.
Secondary outcomes:
measure: Other complications
timeFrame: One month.
Other outcomes:
Locations:
city: Changsha
country: China
facility: Hunan Provincial People's hospital
state: Hunan
Study officials:
affiliation: Hunan Provincial People's Hospital
name: Xiaotong Han, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT00651599: Treatment of Vasomotor Symptoms in Korean Post Menopausal Women
Official title: A Double-blind, Randomized, Placebo-controlled, Multicenter Study Investigating the Efficacy and Tolerability of Angeliq(drospirenon2mg and Estradiol 1mg) in Postmenopausal Korean Women With Vasomotor Symptoms Over 3, 28 Day Treatment Cycle
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Vasomotor Symptoms
Keywords: Vasomotor symptoms
Vasomotor System
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2008-04-03
Enrollment: 90
Sex: FEMALE
Minimum age (years): 45
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Study to demonstrate that the therapeutic efficacy of Angeliq® is better than placebo in Korean postmenopausal women with hot flushes and other climacteric symptoms. Safety and tolerability of Angeliq.


Eligibility criteria: Inclusion Criteria:

* Postmenopausal Korean women suffering from hot flushes

Exclusion Criteria:

* Standard exclusion criteria for HRT clinical trials had to be obeyed, including current or history of hormone dependent malignant disease, thromboembolic disorders, abnormal cervical smear, undiagnosed vaginal bleeding.

Primary outcomes:
measure: Hot flush (frequency and severity)
timeFrame: Daily in pre-treatment and treatment period
Secondary outcomes:
measure: Menopausal symptoms
timeFrame: Baseline and after 4 weeks, 8, 12 and 16 weeks of treatment
measure: Urogenital symptoms
timeFrame: Baseline and after 4 weeks, 8, 12 and 16 weeks of treatment
measure: Assessment of bleeding
timeFrame: daily in pre-treatment and treatment period
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
city: Seoul
country: Korea, Republic of
city: Seoul
country: Korea, Republic of
city: Seoul
country: Korea, Republic of
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT05457699: Ablative Radiotherapy to Consolidate Maximal Systemic Response in Metastatic Prostate Cancer (ANCHOR-Prostate)
Official title: Ablative Radiotherapy to Consolidate Maximal Systemic Response in Metastatic Prostate Cancer (ANCHOR-Prostate)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Prostate Cancer Metastatic
Lead sponsor: Centre hospitalier de l'Université de Montréal (CHUM)
Sponsor class: OTHER
First posted: 2022-07-14
Enrollment: 80
Sex: MALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: A phase IIR cmRCT trial companion to PERa registry, investigating the merit of SABR consolidation in men with metastatic prostate cancer. 80 patients will be randomly selected to be offered experimental SABR based on PSMA-PET detected disease after maximal systemic response. The primary endpoint is the rate of FFS at 1 year. Patients will be stratified according to hormone sensitive vs resistant disease prior to randomisation.


Eligibility criteria: Inclusion Criteria:

3.1.1 Enrolled in PERa (CHUM CER 17.032) and randomly selected for AnChoR-Prostate.

3.1.2 Diagnosis of metastatic prostate cancer having achieved maximum PSA response to SOC systemic therapy defined as two consecutive stable PSA within 6 months of regimen start. Stable PSA is defined as non- progressing (\<25% rise from nadir, per PCWG3 guidelines).

3.1.3 ECOG 0-2 3.1.4 PSA \> 0.2 ng/mL 3.1.5 1-5 sites of PSMA-PET avid disease amenable to SABR.

Exclusion Criteria:

* none

Primary outcomes:
measure: FFS
timeFrame: 1 year
Secondary outcomes:
measure: HRQoL
timeFrame: 5 years
measure: Toxicity
timeFrame: 5 years
measure: Time to progression
timeFrame: 5 years
Other outcomes:
Locations:
city: Montreal
country: Canada
facility: CRCHUM
state: Quebec
Study officials:
References:
Clinical trial NCT03727399: Identification of Allergen-reactive Antibodies in the Blood of Pollen Allergic Patients
Official title: Identification of Allergen-reactive Antibodies in the Blood of Pollen Allergic Patients
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Pollen Allergy
Lead sponsor: Mabylon AG
Sponsor class: INDUSTRY
First posted: 2018-11-01
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The project population will include adult (\> 18 years) patients with a history of grass and birch pollen allergy verified by positive skin prick test and allergen-specific IgE in blood. The study population may also include patients with ongoing or completed AIT.

Brief summary: The project examines the hypothesis that monoclonal allergen-neutralizing antibodies can be recombinantly produced from B lymphocytes isolated from pollen allergic patients. Patient samples suitable for antibody cloning are selected based on seroprofiling for the respective allergens. The study aims at isolating lymphocytes from patients with potential allergen-neutralizing IgG in serum and to clone antibodies from antibody gene sequences obtained from B cells of those patients.


Eligibility criteria: Inclusion Criteria:

* History of allergic rhinitis, conjunctivitis or asthma due to sensitization to grass- or birch Allergens
* Male or female patients older than 18 years
* Written informed consent for providing blood and also to allow experimental manipulation

Exclusion Criteria:

* Age \< 18 years
* Any corticosteroids within the last three days
* Oral corticosteroid therapy within the last ten days
* Parenteral depot corticosteroids within the last three months

Primary outcomes:
measure: Antibody profiling
timeFrame: October 2018 - September 2021
Secondary outcomes:
Other outcomes:
Locations:
city: Zürich
country: Switzerland
facility: Immunologie Zentrum Zürich
Study officials:
References:
Clinical trial NCT04343599: Hypopressive Effectiveness in Postural Control and Pelvic Floor.
Official title: Hypopressive Effectiveness in Postural Control and Pelvic Floor.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pelvic Floor Disorders
Postural; Defect
Muscle Weakness
Lead sponsor: University of Jaén
Sponsor class: OTHER
First posted: 2020-04-13
Enrollment: 130
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: This study was a single-blinded randomized controlled trial
Primary purpose: TREATMENT

Brief summary: Effects of an exercise program based on hypopressive exercises in the female population.

Detailed description: Participants allocated to the intervention group completed 10 weeks of hypopressive exercises training with a frequency of two sessions of 30 minutes twice a week.

Eligibility criteria: Inclusion Criteria:

* Women
* Physical autonomy

Exclusion Criteria:

* Vestibular disorders.
* Coronary diseases.
* Recent surgery.

Primary outcomes:
measure: Postural control
timeFrame: From baseline to 10 weeks.
Secondary outcomes:
measure: Pelvic floor muscles strength
timeFrame: From baseline to 10 weeks.
measure: Self-reported pelvic floor status
timeFrame: From baseline to 10 weeks
measure: Urinary incontinence
timeFrame: From baseline to 10 weeks
measure: Transversus abdominis activation
timeFrame: From baseline to 10 weeks.
measure: Pulmonary ventilation
timeFrame: From baseline to 10 weeks
Other outcomes:
Locations:
city: Jaén
country: Spain
facility: University of Jaen
Study officials:
affiliation: University of Jaén
name: David Cruz-Díaz
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00054899: An Open Label Study of a Peptide Vaccine in Patients With Stage IIb or IIIa Non-Small Cell Lung Cancer
Official title: An Open Label, Multi-center Safety and Tolerance Study of EP2101 Peptide Vaccine in Patients With Stage IIb or IIIa Non-Small Cell Lung Cancer (NSCLC)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Carcinoma, Non-Small-Cell Lung
Lung Neoplasm
Keywords: vaccine
lung
cancer
Carcinoma, Large Cell
Non-Small-Cell Lung Carcinoma
Lead sponsor: Epimmune
Sponsor class: INDUSTRY
First posted: 2003-02-14
Enrollment: 18
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: EP2101 is a new cancer vaccine containing 10 different peptide antigens. The vaccine is designed to activate the immune system to develop a response against tumor cells in order to delay or prevent the recurrence of cancer. This study will test the safety and measure the level of immune stimulating capability of EP2101 in patients with Non-Small Cell Lung Cancer.


Eligibility criteria: Inclusion Criteria:

* Confirmed diagnosis of Non-Small Cell Lung Cancer, stage IIb or IIIa
* At least four weeks following prior standard treatment, with no evidence of disease
* Must use adequate birth control

Exclusion Criteria:

* Prior cancer vaccine therapy or concurrent participation in any other investigational study
* A history of HIV, Hepatitis B or C, or any other acute medical condition which may compromise patient safety or the activity of the study vaccine treatment
* A history of adverse reactions following administration of any vaccines, or a history of hypersensitivity to any components of the study vaccine
* Women who are pregnant, intend to become pregnant, or who are breast feeding

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: University of California, Los Angeles
state: California
city: Orlando
country: United States
facility: Cancer Centers of Florida
state: Florida
city: Albany
country: United States
facility: New York Oncology Hematology
state: New York
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Dallas
country: United States
facility: Mary Crowley Medical Research Center
state: Texas
city: Tyler
country: United States
facility: Tyler Cancer Center
state: Texas
city: Seattle
country: United States
facility: University of Washington
state: Washington
city: Spokane
country: United States
facility: Cancer Care Northwest
state: Washington
Study officials:
References: