louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00261261: Family-Centered Behavioral Preparation for Surgery
Official title: Study of the ADVANCE Behavioral Preparation Program for Children and Their Parents
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anxiety
Keywords: children
anxiety
behavioral preparation
family
surgery
parents
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: National Center for Research Resources (NCRR)
First posted: 2005-12-02
Enrollment: 400
Sex: ALL
Minimum age (years): 2
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Children experience significant anxiety and distress during the preoperative period. Currently available interventions are ineffective and/or associated with significant disadvantages. These interventions exclusively target the child and do not attempt to reduce parental anxiety. Based on an integration of the literature in both the anesthesia and psychological milieus, we developed ADVANCE, a behaviorally oriented anxiety reduction program for children undergoing surgery that targets the family as a whole.

Detailed description: Children and their parents (n=408) were randomly assigned to one of four groups: 1) Control: received standard of care, 2) PPIA: received standard parental presence during induction of anesthesia, 3) ADVANCE: received family-centered behavioral preparation, and 4) oral Midazolam. We assessed the effect of group assignment on anxiety levels and postoperative outcomes.

Eligibility criteria: Inclusion Criteria:

* Children 2-10 years old who were in good health (American Society of Anesthesiology physical status I-II) and who were undergoing general anesthesia and elective, outpatient surgery, and their parents.

Exclusion Criteria:

* Children with a history of chronic illness, prematurity (fewer than 36 weeks gestation) or reported developmental delay

Primary outcomes:
measure: Anxiety in children: modified Yale Preoperative anxiety scale
measure: Anxiety in parents: STAI
Secondary outcomes:
measure: Emergence delirium
measure: Analgesic consumption
measure: Time to discharge from recovery room
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale University
state: Connecticut
Study officials:
affiliation: Yale University
name: Zeev N Kain, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00547261: Phase I Dose Finding Study of SSR97225 Given in Patients With Refractory Cancer
Official title: Phase I Dose Escalation and Pharmacokinetic Study of SSR97225 Administered as a 1 Hour IV Infusion D1 Every 3 Weeks (Arm A) or Administered as a 1hour IV Infusion D1, D8, D15 Every 3 Weeks (Arm B) in Patients With Refractory Solid Tumors
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Neoplasms
Keywords: solid tumor
antimitotic
tubulin binder
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2007-10-22
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine the maximally tolerated dose and the dose limiting toxicity of this antimitotic, tubulin binding investigational drug for those patients who have failed standard anticancer treatments.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of metastatic or locally advanced non-hematological cancer
* Patients with solid tumors refractory to therapy or for whom no therapy exists

Exclusion Criteria:

* Five or more prior chemotherapy lines for metastatic disease
* Eastern Cooperative Oncology Group (ECOG) performance status \>2
* Patients having discontinued previous specific anti-cancer treatment
* Patients who have not recovered from all toxic effects from previous specific anti-cancer treatment (excluding alopecia)
* Patients with abnormal biological/hematological parameters, cardiac abnormalities or serious infection/intercurrent illness likely to jeopardize the patient's safety or the course of the protocol treatment
* No adequate birth control methods

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Primary outcomes:
measure: Maximal tolerated dose (MTD) and dose limiting toxicity (DLT)
timeFrame: Study period
Secondary outcomes:
measure: Pharmacokinetic profile, antitumor activity in patients with measurable disease, effect of drug on CYP3A4 activity
timeFrame: Study period
Other outcomes:
Locations:
city: Bridgewater
country: United States
facility: Sanofi-Aventis Administrative Office
state: New Jersey
Study officials:
affiliation: Sanofi
name: ICD CSD
role: STUDY_DIRECTOR
References:
Clinical trial NCT04981561: Safety and Tolerability of GATE-251 in Normal Human Volunteers
Official title: A Phase 1, Single Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of AGN-241751 After Oral Administration in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Major Depressive Disorder
Keywords: NMDA receptor
NMDA receptor positive allosteric modulator
pharmacokinetics
biomarker
eeg
Lead sponsor: Gate Neurosciences, Inc
Sponsor class: INDUSTRY
First posted: 2021-07-29
Enrollment: 68
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Double blind placebo controlled
Primary purpose: TREATMENT

Brief summary: To evaluate the safety and tolerability of single ascending doses of GATE-251 in normal human volunteers

Detailed description: Single ascending dose (SAD), double-blind placebo-controlled study in normal human volunteers.

Secondary objectives:

To evaluate the pharmacokinetics (PK) and eeg biomarker of target engagement of GATE-251 following increasing single doses of GATE-251.

GATE-251 or Placebo: Dose/Mode of Administration: Single dose; oral

Eligibility criteria: Inclusion Criteria:

* Agree to effective method of birth control
* If female, negative pregnancy test at screening and Day -1
* Nonsmoking at least 2 years
* BMI 18-30
* Supine pulse rate 30-100

Exclusion Criteria:

* Known hypersensitivity to NMDA receptor drugs
* clinically significant disease in any body system
* QTcF \> 430 ms in males, \>450 ms in females
* positive test for hepatitis B or C
* abnormal liver function tests on Day -1
* History of alcohol or other substance abuse during the previous 5 years
* Positive drug screen at screening or Day -1
* Taken any medication within the past 14 days

Primary outcomes:
measure: Treatment emergent adverse events
timeFrame: 28 days
Secondary outcomes:
measure: Pharmacokinetics, maximum plasma concentration
timeFrame: 24 hours
measure: Pharmacokinetics, time to maximum plasma concentration
timeFrame: 24 hours
measure: Pharmacokinetics, area under the curve for plasma concentration
timeFrame: 72 hours
Other outcomes:
Locations:
Study officials:
affiliation: Gate Neurosciences, Inc
name: Ronald M Burch, MD PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT01645761: Additive Effect of Endonase on Eradication Rate of First Line Therapy for Helicobacter Pylori
Official title: Additive Effect of Endonase on Eradication Rate of the 7-day Standard Proton Pump Inhibitor-based Triple Therapy for Helicobacter Pylori
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gastric Ulcer Associated With Helicobacter Pylori
Keywords: Helicobacter pylori eradication
Peptic ulcer
Lead sponsor: Chuncheon Sacred Heart Hospital
Sponsor class: OTHER
First posted: 2012-07-20
Enrollment: 112
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: Endonase, a kind of protease, is known to cause both extensive degradation of mucins and a reduction in mucus viscosity. As part of the search for more effective forms of therapy against H. pylori when it colonizes not only the surface of the surface mucosal cells but also the surface mucous gel layer covering the mucosal surface of the stomach. The investigators decided to investigate whether or not endonase might have additive effect of pronase on the efficacy of eradication therapy against Helicobacter pylori.


Eligibility criteria: Inclusion Criteria:

Male or Female with 18 years or more of age without history of H. pylori eradication AND

1. Patients with H. pylori associated peptic ulcer in scar stage, OR
2. Non-ulcer dyspepsia patients with H. pylori infection

Exclusion Criteria:

1. Under 18 years, OR
2. Patients with a history of previous treatment of H. pylori infection, OR
3. Pregnant or Breast feeding women, OR
4. Patients with severe renal, liver, or heart disease, OR
5. Patients with gastric malignancy, OR
6. Patients with a history of drug allergy or hypersensitivity, OR
7. Patients who had received treatment with antibiotics or proton pump inhibitors, H2 Blocker, Bismuth preparation, Anticoagulant, Ketoconazole, Glucocorticoid during the 2 weeks preceding endoscopy

Primary outcomes:
measure: Eradication rate
timeFrame: 4 weeks
Secondary outcomes:
measure: Number of participants with adverse events
timeFrame: 4 weeks
measure: Number of participants taking over 85% of medicine
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Chuncheon
country: Korea, Republic of
facility: Chuncheon Sacred Heart Hospital
state: Gangwon
Study officials:
affiliation: Department of Internal Medicine, Hallym university college of medicine
name: Jin Bong Kim, MD
role: STUDY_CHAIR
affiliation: Department of Internal Medicine, Hallym University College of Medicine
name: Yeon Soo Kim, MD, PhD.
role: STUDY_DIRECTOR
affiliation: Department of Internal Medicine, Hallym University of College of Medicine
name: Chang Seok Bang, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bang CS, Kim YS, Park SH, Kim JB, Baik GH, Suk KT, Yoon JH, Kim DJ. Additive Effect of Pronase on the Eradication Rate of First-Line Therapy for Helicobacter pylori Infection. Gut Liver. 2015 May 23;9(3):340-5. doi: 10.5009/gnl13399.
Clinical trial NCT02592161: Clinical Study of Efficacy and Safety of Chung A Won in Women's Patients With Osteoporosis
Official title: A Randomized, Single Center, Double Blind, Parallel, Placebo-controlled Clinical Study of Efficacy and Safety of Chung A Won in Women's Patients With Osteoporosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Osteoporosis
Lead sponsor: Korea Health Industry Development Institute
Sponsor class: OTHER_GOV
First posted: 2015-10-30
Enrollment: 166
Sex: FEMALE
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A randomized, single center, double blind, parallel, placebo-controlled, clinical study of efficacy and safety of Chung A Won and placebo for 24 weeks three times a day on the improvement of osteoporosis and symptoms in Women's older than 50 patients with osteoporosis.


Eligibility criteria: Inclusion Criteria:

1)Female more than 50 years old in osteoporosis

Exclusion Criteria:

1. Wash out peroid: using agents more than 3 months against osteoporosis
2. Subject who takes drugs that may affect the clinical trials (Corticosteroids, anticonvulsants, tranquilizers, antidepressants, hypnotic, diuretic)
3. Subject who has a chronic liver disease, thyroid disease and chronic renal disease
4. Subject who is chronic alcoholics and undernourished
5. Other conditions were not suitable in study : Severe physical defects mental defects
6. Pregnant woman
7. Subject who is not calibrated hypercalcemia/hypocalcemia
8. Secondary osteoporosis : Subject who takes drugs(Glucocorticoid, Diabetes Medications)
9. Subject who has 60% more fracture risk in FRAX(WHO fracture risk assessment tool)

Primary outcomes:
measure: The change of T-score of bone mineral density(QCT)
timeFrame: baseline, After 24 weeks(± 3 days) from the baseline of the trial
Secondary outcomes:
measure: The change of T-score
timeFrame: baseline, After 4 weeks, 12 weeks from the baseline of the trial
measure: The change of osteoporosis-related indicators of blood tests
timeFrame: baseline, After 4 weeks, 12 weeks, 24 weeks(endpoint) from the baseline of the trial
measure: The change of ODI(Oswestry Disability Index)
timeFrame: baseline, After 4 weeks, 12 weeks, 24 weeks(endpoint) from the baseline of the trial
measure: The change of QVAS(Quardruple Visual Analog Scale)
timeFrame: baseline, After 4 weeks, 12 weeks, 24 weeks(endpoint) from the baseline of the trial
measure: The change of kupperman index
timeFrame: baseline, After 4 weeks, 12 weeks, 24 weeks(endpoint) from the baseline of the trial
measure: The change of shin-huh symptoms
timeFrame: baseline, After 4 weeks, 12 weeks, 24 weeks(endpoint) from the baseline of the trial
measure: The change of quality of life using SF-36
timeFrame: baseline, After 4 weeks, 12 weeks, 24 weeks(endpoint) from the baseline of the trial
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00851461: Effect of Goserelin (Zoladex®) in Spinal and Bulbar Muscular Atrophy
Official title: Effect of Goserelin (Zoladex®) in Spinal and Bulbar Muscular Atrophy in Thai Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Spinobulbar Muscular Atrophy
Kennedy's Disease
Keywords: Spinobulbar muscular atrophy
Kennedy's disease
Goserelin
Electrophysiologic study
Inclusion body
Lead sponsor: Ramathibodi Hospital
Sponsor class: OTHER
Collaborators: name: AstraZeneca
First posted: 2009-02-26
Enrollment: 10
Sex: MALE
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a therapeutic trial study to demonstrate whether Goserelin, a LHRH agonist has benefit in SBMA

Objective:

1. To study effects of Goserelin to clinical course of patients with spinal and bulbar muscular atrophy in Thailand
2. To demonstrate physiological and pathological changes in treated patients with Goserelin.
3. To assess tolerability and adverse effect of Goserelin therapy


Eligibility criteria: Inclusion Criteria:

1. Provision of informed consent
2. Males, age over 20 years, undesired fertility
3. Have positive family history of muscle weakness with these clinical signs:

   * bulbar involvement (difficulty in breathing, swallowing, talking)
   * muscle atrophy with or without fasciculation
   * decrease or normal deep tendon reflex
   * normal Babinski response
   * no sensory impairment
   * mild tremor (either postural or intention)
   * gynecomastia
   * decrease libido and infertility
4. Subjects have a confirmed diagnosis to SBMA by both NCV test and DNA study demonstrated the number of CAG repeated more than 35.

Exclusion Criteria:

1. Have weakness caused by other etiologies and have liver or kidney disease.
2. Have currently prostatic cancer
3. Want to have a child
4. Participation in a clinical study during the last 30 days.
5. Females and children age \< 20 years old

Primary outcomes:
measure: muscle power
timeFrame: every 3 months
Secondary outcomes:
measure: electrophysiologic study (Nerve conduction and Electromyogram)
timeFrame: every 3 months
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Medical Genetics and Molecular Medicine Unit,, Department of Medicine, Ramathibodi Hospital
Study officials:
affiliation: Ramathibodi Hospital
name: Thanyachau Sura, M.D., MRCP
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06268561: Ozurdex Endophtamitis Cohort, Prognostic Assessment at 12 Months
Official title: Ozurdex Endophtamitis Cohort, Prognostic Assessment at 12 Months
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Endophthalmitis
Keywords: OZURDEX
Visual Acuity
Endophtalmitis
Lead sponsor: Centre Hospitalier Universitaire de Saint Etienne
Sponsor class: OTHER
First posted: 2024-02-20
Enrollment: 8
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: Patients treated by Dr Garcin and Pr Thuret CHU of Saint Etienne in the context of post-OZURDEX endophthalmitis

Brief summary: OZURDEX endophthalmitis is a rare and potentially very serious pathology. Different treatments can be carried out early and change the functional prognosis of the patient.


Eligibility criteria: Inclusion Criteria:

* Patient who had endophtalmitis following an OZURDEX implant injection within 2 months

Exclusion Criteria:

* Intra oculaire procedure in the interval between the injection of OZURDEX and endophtalmitis

Primary outcomes:
measure: Visual acuity
timeFrame: 2018 to 2023
Secondary outcomes:
measure: IOP measured in mmHg by tonometer and confirmed with Goldman Applanation
timeFrame: 2018 to 2023
measure: Tomography
timeFrame: 2018 to 2023
measure: Resumption of intravitreal therapy
timeFrame: 2018 to 2023
Other outcomes:
Locations:
city: Saint-Étienne
country: France
facility: CHU Saint Etienne
Study officials:
affiliation: CHU SAINT-ETIENNE
name: Thibaud GARCIN, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05931861: Performance and Safety Assessment of T2769 in Contact Lens Wearers With Dry Eye Symptoms.
Official title: Performance and Safety Assessment of T2769 in Contact Lens Wearers With Dry Eye Symptoms.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dry Eye
Lead sponsor: Laboratoires Thea
Sponsor class: INDUSTRY
First posted: 2023-07-05
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a confirmatory clinical investigation. The objective is to collect new additional clinical data demonstrating the safety and performance of the device in the contact-lens wearing population with dry eyes. The hypotheses are that T2769 improves dry eye symptomatology (e.g. decrease in CLDEQ-8 score, in OSDI score, ocular discomfort assessed by VAS) and signs (e.g. increase in Schirmer and TBUT, decrease in Oxford score) at D36, in comparison to baseline.

The primary objective of this investigation is to assess the performance of T2769 in contact lens wearers with dry eye symptoms in terms of change from baseline (Day 1) to Day 36 (Final visit) in Contact Lens Dry Eye Questionnaire-8 (CLDEQ-8) total score.


Eligibility criteria: Main Inclusion Criteria:

* Informed consent signed and dated
* Patient aged ≥ 18 years old
* Well fitted contact lenses (CL) according to the investigator judgement
* Daily wearer of any type of CL for a minimum of 5 days/week for 6 hours/day over at least the last month and is willing to continue to do so during the study
* Patient with an Ocular Surface Disease Index (OSDI) score ≥ 18
* CLDEQ-8 score ≥ 12

Main Exclusion Criteria:

* Far Best-Corrected Visual Acuity (BCVA) ≥+0.7 LogMar (e.g., ≤0.2 in decimal value or ≤20/100 Snellen equivalent or ≤50 ETDRS letters).
* Severe blepharitis
* Severe Meibomian gland dysfunction
* Palpebral or nasolacrimal disorders
* Dry eye associated with at least one of the following diseases/symptoms: ocular rosacea, Pterygium, Eyelid malposition, Corneal dystrophy, Ocular neoplasia, Filamentous keratitis, Corneal neovascularisation, Orbital radiotherapy, Cataract, Retinal disease.

Primary outcomes:
measure: Change From Baseline in Contact Lens Dry Eye Questionnaire-8 (CLDEQ-8) Total Score.
timeFrame: CLDEQ- score is assessed at Day 1 and Day 36
Secondary outcomes:
Other outcomes:
Locations:
city: Burgas
country: Bulgaria
facility: Medical Center "Oxycom"
city: Smolyan
country: Bulgaria
facility: "Asmp Ob - Ip Glm" Eood
city: Sofia
country: Bulgaria
facility: Medical Center For Eye Health "Focus"
city: Sofia
country: Bulgaria
facility: Specialized Ophthalmological Hospital For Active Treatment "Pentagram"
city: Stara Zagora
country: Bulgaria
facility: Medical Center "Vereya"
city: Varna
country: Bulgaria
facility: Ambulatory For Group Practice For Specialized Medical Care For Eye Diseases - Dr. Grupchevi
Study officials:
affiliation: Individual Practice for Specialized Ophthalmology Care
name: Christina Grupcheva, Professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01491061: Ranolazine Loading to Prevent PCI-induced Myocardial Injury
Official title: TWice overnIght High-dose ranoLazIne Pretreatment for preventinG Myocardial iscHemic Damage in Patients With Stable Angina Undergoing percuTaneous Coronary Intervention
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Coronary Artery Disease
Keywords: periprocedural myocardial infarction
ranolazine
Lead sponsor: University of Roma La Sapienza
Sponsor class: OTHER
First posted: 2011-12-13
Enrollment: 100
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: It has previously been shown that pretreatment with ranolazine 1,000 mg twice daily for 7 days can significantly reduce procedural myocardial injury in elective percutaneous coronary intervention (PCI). The investigators tested the hypothesis that twice overnight high-dose ranolazine loading before PCI can reduce the peri-procedural myocardial ischemic damage similarly to long-term pre-treatment with standard doses.

Detailed description: Background

Ranolazine is a novel antianginal drug that reduces intracellular sodium and calcium accumulation during ischemia thus limiting ischemic injury.

It has previously been shown that pretreatment with ranolazine 1,000 mg twice daily for 7 days can significantly reduce procedural myocardial injury in elective percutaneous coronary intervention.

It remains unknown, however, which of these two therapeutic approaches is more effective after PCI.

Purpose

The primary objective of this study is to test the hypothesis that twice overnight high-dose ranolazine loading before PCI can reduce the peri-procedural myocardial ischemic damage similarly to long-term pre-treatment with standard doses.

Eligibility criteria: Inclusion Criteria:

* Angiographically-proven coronary artery disease
* Class I indication to elective percutaneous coronary intervention
* Stable conditions
* No recent acute coronary syndromes
* Normal baseline values of markers of myocardial damage (creatine kinase, creatine kinase-MB, myoglobin, and troponin I)
* Able to understand and willing to sign the informed consent form

Exclusion Criteria:

• Women of child bearing potential patients must demonstrate a negative pregnancy test performed within 24 hours before

Primary outcomes:
measure: Frequency of PCI-induced myocardial infarction
timeFrame: Up to 48 hours after PCI
Secondary outcomes:
measure: Assessment of post-PCI peak values of markers of myocardial damage
timeFrame: Baseline and 48 hours after PCI
measure: Rate of 30-day MACE
timeFrame: Up to 30 days after PCI
Other outcomes:
Locations:
city: Rome
country: Italy
facility: San Raffaele Pisana
Study officials:
References: