louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00531401: Study of Salirasib to Treat Non-Small Cell Lung Cancer
Official title: Salirasib for Treatment of Advanced Non-Small Cell Lung Cancer: a Phase II Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Carcinoma, Non-Small-Cell Lung
Keywords: Non-Small-Cell Lung
Lead sponsor: Concordia Pharmaceuticals, Inc
Sponsor class: INDUSTRY
First posted: 2007-09-18
Enrollment: 71
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this study is to determine whether Salirasib is effective to shrink or prevent the growth of the tumors associated with non-small cell lung cancer in both patients who are newly diagnosed or have recurrent disease.


Eligibility criteria: Inclusion Criteria:

* Age 18 or older
* Non-Small Cell Lung Cancer not amenable to curative therapy with surgery or radiation
* Measurable disease
* Adenocarinoma of the lung, have not received prior chemotherapy for the malignancy and has a ≥ 15 pack year history of smoking; OR previously treated with recurrent disease and documented KRAS mutation
* Last dose of radiotherapy \> 3 weeks prior to study entry and recovered from all acute toxicities associated with the prior therapy
* No history of another malignancy in the past 5 years except treated non-melanomatous skin cancer or superficial bladder cancer or carcinoma-in-situ of the cervix
* Karnofsky Performance status of 70 or greater
* Body Weight \> 50 kg
* Life expectancy ≥ 3 months
* Serum Creatinine ≤2.0 mg/dL, total bilirubin ≤ 2.0 mg/dL, ALT and AST ≤ 3x ULN, alkaline phosphatase ≤ 5x ULN, WBC \> 3000/mm³, ANC ≥ 1500/mm³, platelets ≥ 100,000/mm³, hemoglobin ≥ 10g/dL.
* No coexisting cardiac or medical problems that would limit compliance in the study
* Willing to undergo blood sampling for pharmacokinetic analysis
* Negative pregnancy test, if applicable

Exclusion Criteria:

* Evidence of active heart disease including myocardial infarction within previous 3 months
* Active infectious process
* Active central nervous system metastases (requiring increasing doses of corticosteroids over the prior month, known progressing lesions)
* Pregnant or lactating
* Major surgery without full recovery or major surgery within 3 weeks prior to treatment start
* QTc Interval \> 470 msec
* Gastrointestinal tract disease resulting in inability to take or absorb oral medications

Primary outcomes:
measure: Rate of non-progression (as reflected in the tumor control rate of percent patients with CR+PR+SD) defined as the number of patients whose tumor did not progress (<20% tumor increase to total disappearance of tumor according to RECIST)
timeFrame: 10 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Gregory J Riely, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05354401: Heated Humidified High Flow Nasal Cannula Oxygen in Obstructive Sleep Apnea in Adolescents
Official title: Use of Heated Humidified High Flow Nasal Cannula Oxygen in Obstructive Sleep Apnea in Adolescents With Obesity and Complex Medical Conditions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Obstructive Sleep Apnea (Moderate to Severe)
Central Sleep Apnea
Lead sponsor: The Hospital for Sick Children
Sponsor class: OTHER
First posted: 2022-04-29
Enrollment: 20
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The research study is being done to test heated humidified high-flow air (HHF), as a treatment for OSA.


Eligibility criteria: OBESE SUBJECTS:

Inclusion Criteria:

* Obesity, defined as a BMI \> 95th percentile for age and gender
* Age 10 through 18 years
* Informed consent with assent in accordance with the institutional policies (institutional IRB approval) must be signed by the patient's legally authorized guardian acknowledging written consent to join the study
* Moderate-severe OSA or Central Sleep Apnea (CSA) as defined by OAHI or CAHI

Exclusion Criteria:

* Patients with other neurological problems, including but not limited to neurocutaneous disorders such as neurofibromatosis or tuberous sclerosis
* Obesity due to other diseases and syndromes (e.g. Prader-Willi syndrome)
* Pregnancy
* Currently unwell, hospitalized or recent viral/bacterial infection in the previous 4 weeks
* Adenoidal and/or tonsillar hypertrophy which may be amenable to surgical intervention to help alleviate OSA
* Patients with severe respiratory distress
* Patients with increased risk of pneumothorax including but not limited to previous pneumothorax, bronchiectasis or severe untreated asthma.

CHILDREN WITH MEDICAL COMPLEXITY SUBJECTS:

Inclusion Criteria:

* CMC recently diagnosed with moderate to severe OSA or CSA requiring CPAP therapy
* 0-18 years of age
* Informed consent with assent in accordance with the institutional policies (institutional IRB approval) must be signed by the patient's legally authorized guardian acknowledging written consent to join the study

Exclusion Criteria:

* Current upper respiratory tract infection
* Subjects who are receiving oxygen therapy

Primary outcomes:
measure: Change in apnea-hypopnea index (AHI) with HHF compared to the change in AHI with CPAP
timeFrame: week 1-4
Secondary outcomes:
measure: Comparative COMFORT scales with HHF and CPAP.
timeFrame: week 1-4
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Hospital for Sick Children
state: Ontario
Study officials:
affiliation: The Hospital for Sick Children
name: Indra Narang, BMEDSci, MBBCH, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05672901: Silicone Gel Vs. Estrogen Vaginal Cream for the Management of Genitourinary Syndrome of Menopause
Official title: Comparison of a Novel Silicone Gel Vs. Estrogen Vaginal Cream for the Management of Genitourinary Syndrome of Menopause: a Non-inferiority Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Genitourinary Syndrome of Menopause
Lead sponsor: Stratpharma AG
Sponsor class: INDUSTRY
First posted: 2023-01-05
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The goal of this randomized controlled trial is to test the efficacy of StrataMGT in the management of Genitourinary Syndrome of Menopause (GSM) compared to estrogen therapy. The main question it aims to answer is:

- Will StrataMGT be non-inferior regarding patient quality of life compared to standard of care?

Participants will use either StrataMGT or estrogen vaginal cream to treat GSM for 3 consecutive months. After the baseline assessment, participants will be assessed monthly for quality of life, clinical signs, symptoms, pathology and adverse reactions.


Eligibility criteria: Inclusion Criteria:

* Able to provide informed consent
* Confirmed postmenopausal age
* Diagnosed genitourinary syndrome of menopause
* Access to a smartphone, tablet or computer, and to a functional email address.

Exclusion Criteria:

* Contraindication for the use of estrogen therapy
* Unable to provide informed consent
* Patient unable to apply topical device
* Allergy or intolerance to ingredients or excipients of the formulation of studied products

Primary outcomes:
measure: PROM: Quality of Life
timeFrame: 3 months
Secondary outcomes:
measure: Clinical signs
timeFrame: 3 months
measure: Adverse Reactions
timeFrame: 3 months
measure: Visual pathology
timeFrame: 3 months
measure: PROM: Symptoms
timeFrame: 3 months
measure: PROM: Dyspareunia
timeFrame: 3 months
measure: PROM: Product Rating
timeFrame: 3 months
measure: PROM: Treatment Adherence
timeFrame: 3 months
Other outcomes:
Locations:
city: Laguna Hills
country: United States
facility: Orange Coast Women's Medical Group
state: California
city: Miami
country: United States
facility: Abba Medical Group
state: Florida
city: Johns Creek
country: United States
facility: One Health Research Clinic
state: Georgia
Study officials:
References:
Clinical trial NCT03911401: Comparison Trial of OPA-15406 Ointment in Pediatric Patients With Atopic Dermatitis
Official title: A Multicenter, Randomized, Double-blind, Vehicle Controlled, Parallel-group Comparison Trial to Demonstrate the Superiority of 0.3% and 1% OPA-15406 Ointment to the Vehicle in Pediatric Patients With Atopic Dermatitis (Phase 3 Trial)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Atopic Dermatitis
Lead sponsor: Otsuka Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2019-04-11
Enrollment: 251
Sex: ALL
Minimum age (years): 2
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To demonstrate the superiority of the investigational medicinal product (IMP; 0.3% OPA-15406 ointment, 1% OPA-15406 ointment, or vehicle) to the vehicle when administered twice daily for 4 weeks using success rate in Investigator's Global Assessment (IGA) at Week 4 as the primary endpoint in pediatric patients with Atopic Dermatitis (AD).


Eligibility criteria: Inclusion Criteria:

* Diagnosis of AD based on the Japanese Dermatological Association's criteria
* Atopic dermatitis affecting more than or equal to 5%, to less than or equal to 40% of body surface area (BSA, excluding scalp) at the screening and baseline examinations
* IGA score of 2 or 3 at the screening and baseline examinations

Exclusion Criteria:

* Subjects who have an AD or contact dermatitis flare-up defined as a rapid intensification of AD, within 28 days prior to the baseline examination

Primary outcomes:
measure: Responder Rate of Investigator's Global Assesment (IGA) of Disease Severity
timeFrame: At Week 4
Secondary outcomes:
measure: Change From Baseline in Eczema Area and Severity Index (EASI) Score
timeFrame: Baseline, Week 4
measure: Change From Baseline in Verbal Rating Scale (VRS) for Pruritus Score
timeFrame: Baseline, Week 4
Other outcomes:
Locations:
city: Sapporo
country: Japan
facility: Kato Dermatology Clinic
Study officials:
affiliation: Otsuka Pharmaceutical Co., Ltd.
name: Osamu Sato
role: STUDY_DIRECTOR
References:
citation: Saeki H, Baba N, Ito K, Yokota D, Tsubouchi H. Difamilast, a selective phosphodiesterase 4 inhibitor, ointment in paediatric patients with atopic dermatitis: a phase III randomized double-blind, vehicle-controlled trial. Br J Dermatol. 2022 Jan;186(1):40-49. doi: 10.1111/bjd.20655. Epub 2021 Nov 1.
Clinical trial NCT00067301: PUFA Augmentation in Treatment of Major Depression
Official title: PUFA Augmentation in Treatment of Major Depression
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Major Depression
Keywords: depression
citalopram
Celexa
Polyunsaturated Fatty Acids
omega-3
EPA
antidepressants
Lead sponsor: National Center for Complementary and Integrative Health (NCCIH)
Sponsor class: NIH
First posted: 2003-08-15
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine if omega-3 fatty acid EPA will enhance and speed up response to antidepressant therapy with Celexa (Citalopram) in people suffering from Major Depressive Disorder. All patients will receive Celexa, 50% will receive EPA, 50% placebo EPA.

Detailed description: As per brief summary

Eligibility criteria: Inclusion Criteria:

* Meet DSM-IV criteria for current major depression, and have a HAM-D (21 item) score of \> 17
* Male or female who, if of child-bearing potential, agrees to use effective contraception including the regular use of contraceptive pills, intra-uterine devices, barrier methods or abstinence
* Age between 18 and 65
* Capable of giving informed consent

Exclusion Criteria:

* Diagnosis of schizophrenia, schizophreniform disorder, schizoaffective disorder, schizotypal disorder, psychotic depression or bipolar disorders
* Current drug or alcohol abuse or dependence, or history of drug or alcohol abuse or dependence within the previous 6 months
* Unstable medical or neurological conditions that are likely to interfere with the treatment of depression
* History of allergy to citalopram or ProEPA, finfish or shellfish
* History of failure of response to citalopram, as documented by an adequate trial of the medication \[defined as having been treated with the medication at a dose level typically regarded as adequate (i.e., 40 mg of citalopram per day) for at least 6 weeks\]
* History of seizure disorder
* Pregnancy
* Currently on psychotropic medications including antidepressants or neuroleptics
* Active suicidal ideation or other safety issues determined by the clinician to not be suitable for inclusion in the study
* Exposure to treatment with fluoxetine or MAOIs in the previous two months
* Patients on anticoagulant therapy
* Patients with a dietary intake of \> 3.0g total omega-3 PUFA/day at baseline

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Cedars-Sinai Medical Center Dept. of Psychiatry
state: California
Study officials:
affiliation: Cedars-Sinai Medical Center
name: Lev Gertsik, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Appleton KM, Voyias PD, Sallis HM, Dawson S, Ness AR, Churchill R, Perry R. Omega-3 fatty acids for depression in adults. Cochrane Database Syst Rev. 2021 Nov 24;11(11):CD004692. doi: 10.1002/14651858.CD004692.pub5.
Clinical trial NCT06112301: Pivotal, Clinical Study for the Accuracy Evaluation of the IdentiClone Dx IGH Assay
Official title: Pivotal, Clinical Study for the Accuracy Evaluation of the IdentiClone Dx IGH Assay
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: B-Cell Lymphoproliferative Disorder
Lead sponsor: Invivoscribe, Inc.
Sponsor class: INDUSTRY
First posted: 2023-11-01
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Samples from subjects with diagnosed B-Cell Lymphoproliferative disorders or suspected of B-Cell Lymphoproliferative disorders with negative B-Cell Clonality Testing results

Brief summary: This protocol describes the pivotal accuracy study for the IdentiClone Dx IGH (IC IGH Dx) Assay. The intent of the accuracy study is to demonstrate agreement between the results of the IC IGH Dx Assay and a predicate devise or assay on retrospective and residual de-identified DNA extracted from peripheral blood (PB) samples from individuals with suspected B-Cell Lymphoproliferations. The predicate device will be the LymphoTrack Dx IGH (FR1/FR2/FR3) Assays - MiSeq (LT Dx IGH-CE-IVD), which is a CE-IVD assay with a similar intended use as the IC IGH Assay on the same sample type.


Eligibility criteria: Inclusion Criteria:

1. DNA extracted from Peripheral Blood (PB) with EDTA as anticoagulant with minimum total DNA ≥ 2 µg with concentration at ≥ 50ng/µl
2. DNA extracted from PB specimens no more than 7 days
3. DNA stored at -15°C to -30°C up to 5 years
4. Donor Age: ≥ 18
5. For positive sample, DNA from PB of subjects diagnosed (at the time the specimen was drawn) with Lymphoproliferative disease, with:

   1. ICD 10 Codes: C8300, C8330, C8510 or other B-cell leukemia/lymphoma diagnosis
   2. B-cell Lymphoproliferative disease diagnosis per collection site procedure (i.e. SNOMED)
6. For negative sample, DNA from PB of subjects suspected of Lymphoproliferative disease

Exclusion Criteria:

1. PB specimens that have been frozen prior to extraction

Primary outcomes:
measure: % Agreement
timeFrame: Through Study Completion at one year
Secondary outcomes:
Other outcomes:
Locations:
city: San Diego
country: United States
facility: Invivoscribe, Inc.
state: California
city: Hallbergmoos
country: Germany
facility: LabPMM GmbH
city: Kawasaki-shi
country: Japan
facility: LabPMM GK
state: Kanagawa
Study officials:
References:
Clinical trial NCT00275301: PET Imaging and Olanzapine Treatment in Borderline Personality Disorder
Official title: Brain Correlates of Olanzapine Treatment Response in BPD
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Borderline Personality Disorder
Keywords: Borderline Personality Disorder
BPD
PET
olanzapine
brain
Lead sponsor: University of Minnesota
Sponsor class: OTHER
Collaborators: name: Eli Lilly and Company
First posted: 2006-01-11
Enrollment: 19
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The overall design of the study is to perform both a PET and MRI scan on objectively identified borderline personality disorder patients, to treat them with olanzapine for 8 weeks, and to then re-scan the patients with PET.

Detailed description: The primary objective of this proposed study will be to compare the baseline PET scan to the endpoint scan in 15 BPD patients who have been treated with olanzapine. The comparison of the scans will be done through a statistical image analysis, using a pixel-by-pixel group mean subtraction strategy with appropriate correction for multiple comparisons. In an exploratory fashion we will compare frontal and temporal regions of interest to address hypotheses of which areas of the brain might show changes with olanzapine treatment.

A secondary objective is to use a normal database to compare the baseline PET scan of the 15 patients in a medication free state to normal subjects. The advantage of this strategy is the ability to closely match subjects by gender and age. As noted earlier, Dr. Pardo has data on 35 control subjects studied on the same scanner we plan to use for this study.

Eligibility criteria: Inclusion Criteria:

1. Age 18-45 years
2. Diagnosis: borderline personality disorder by DSM-IV criteria
3. Gender: Female
4. May have history of substance use and other Axis II disorders

Exclusion Criteria:

1. Axis I diagnosis of schizophrenia, schizoaffective disorder, or bipolar I disorder during the subject's lifetime. No current major depression or PTSD.
2. Treatment with psychotropic medication in the previous month.
3. Medical disorder that would influence outcome of the study - e.g. epilepsy, thyroid disease, HIV, etc.
4. Medical disorder that would not allow use of olanzapine
5. Active substance abuse or dependence
6. Previous adverse reaction to olanzapine
7. Females whom are pregnant or nursing

Primary outcomes:
measure: Change in Brain Metabolism From Baseline to Eight Weeks as Seen in PET Scan
timeFrame: Baseline to 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: University of Minnesota, Dept of Psychiatry
state: Minnesota
Study officials:
affiliation: University of Minnesota
name: S. Charles Schulz, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04423601: Effect of Itraconazole on the Pharmacokinetics of SHR6390 in Healthy Subjects
Official title: A Single-centre, Open, Single-dose, Self-control Study to Investigate the Effect of Itraconazole on the Pharmacokinetics of SHR6390 in Healthy Chinese Adult Subjects.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Subjects
Lead sponsor: Jiangsu HengRui Medicine Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2020-06-09
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The primary objective of the study is to evaluate the effect of itraconazole on pharmacokinetics of healthy Chinese adult subjects after oral administration of SHR6390 tablets. The secondary objective of the study is to evaluate the safety of SHR6390 alone and when co-administered with itraconazole. The exploratory objective of the study is to explore the effect of SHR6390 related metabolic enzymes and transporter gene polymorphisms on the pharmacokinetics of SHR6390.


Eligibility criteria: Inclusion Criteria:

1. Sign the informed consent before the trial, and fully understand the trial content, process and possible adverse reactions;
2. Ability to complete the study as required by the protocol;
3. Healthy male or female subjects aged 18 to 45 (including 18 and 45) at the date of signing the informed consent;
4. Male body weight ≥ 50 kg, female body weight ≥ 45 kg, and body mass index (BMI) within the range of 19 \~ 26 kg /m2 (including 19 and 26);

Exclusion Criteria:

1. Allergic constitution;
2. History of drug use, or drug abuse screening positive;
3. Alcoholic or often drinkers;
4. Left ventricular ejection fraction (LVEF) \<50% by echocardiography;
5. A clear medical history of important primary organ diseases such as nervous system, cardiovascular system, urinary system, digestive system, respiratory system, metabolism and musculoskeletal system.
6. Abnormal clinical laboratory tests and clinical significance judged by the investigator or other clinical findings showing the following diseases, including but not limited to gastrointestinal tract, kidney, liver, nerve, blood, endocrine, tumor, lung, immune, mental or cardiovascular and cerebrovascular diseases.

Primary outcomes:
measure: Pharmacokinetics parameter: Cmax of SHR6390
timeFrame: through study completion, an average of 32 days
measure: Pharmacokinetics parameter: AUC of SHR6390
timeFrame: through study completion, an average of 32 days
Secondary outcomes:
measure: Pharmacokinetics parameter: Tmax of SHR6390
timeFrame: through study completion, an average of 32 days
measure: Pharmacokinetics parameter: T1/2 of SHR6390
timeFrame: through study completion, an average of 32 days
measure: Pharmacokinetics parameter: CL/F of SHR6390
timeFrame: through study completion, an average of 32 days
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Sun Yat-sen Memorial Hospital, Sun Yat-sen University
state: Guangdong
Study officials:
References: