louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03424473: Expanded Access Use of Tucatinib for HER2+ Metastatic Breast Cancer
Study type: EXPANDED_ACCESS
Overall status: NO_LONGER_AVAILABLE
Keywords: tucatinib
Breast Cancer
ARRY-380
ONT-380
HER2 Positive Breast Carcinoma
HER2 Positive Locally Advanced Breast Cancer
HER-2 Positive Breast Cancer
HER-2 Positive Locally Advanced Breast Cancer
Recurrent Breast Carcinoma
Stage IV Breast Cancer
Metastatic Breast Cancer
Breast Carcinoma
Metastatic Malignant Neoplasm in the Brain
Brain Metastases in Breast Cancer
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Lead sponsor: Seagen Inc.
Sponsor class: INDUSTRY
First posted: 2018-02-07
Standard ages: CHILD
ADULT
OLDER_ADULT

Brief summary: Physicians interested in requesting a single patient IND should contact Seattle Genetics' Medical Information (medinfo@seagen.com).


Eligibility criteria: Inclusion Criteria:

-

Exclusion Criteria:

-

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00469573: Safety and Efficacy of Optive in Contact Lens Wearers With Dry Eyes
Official title: Safety and Efficacy of Optive in Contact Lens Wearers With Dry Eyes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Dry Eye
Lead sponsor: Innovative Medical
Sponsor class: INDUSTRY
First posted: 2007-05-04
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP

Brief summary: The purpose of this study is to determine if Optive®eye drops are safe for people who wear contact lenses and have dry eyes. The second goal of the study is to determine if using Optive®eye drops can improve my dry eye scores on a standard dry eye test (called the OSDI).


Eligibility criteria: Inclusion Criteria:

* Men and women 18 and over

  * Self-reported use of daily-wear soft contact lenses that have been a proper fit for at least one month prior to the screening visit.
  * Complaint of dry eyes
  * OSDI score \> 23

Exclusion Criteria:

* Use of RGP or PMMA contact lenses

  * Poorly fitting contact lenses
  * Concurrent ocular conditions or pathology that could affect contact lens fit or patient's ability to complete study
  * Concurrent use of topical medications other than study medications
  * Use of systemic medications with ocular drying sequelae:

    * Antihistamines
    * Decongestants
    * Antispasmotics Antidepressants Change in contact lens care solutions within the prior 30 days

Primary outcomes:
measure: Safety
timeFrame: 8 months
Secondary outcomes:
measure: Efficacy
timeFrame: 8 months
Other outcomes:
Locations:
city: Wantagh
country: United States
facility: South Shore Eye Care
state: New York
Study officials:
affiliation: South Shore Eye Care
name: Jodi Luchs, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01708473: Feasibility Study: Compare the Effectiveness Between Two Pain Medications When Used Prior to Ultherapy™ Treatments
Official title: Feasibility Study: Comparison Of Advil® Vs. Lortab® For Reducing Discomfort Associated With Ultherapy™ Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Skin Laxity
Lead sponsor: Merz North America, Inc.
Sponsor class: INDUSTRY
First posted: 2012-10-17
Enrollment: 20
Sex: ALL
Minimum age (years): 30
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will compare the effectiveness of two pain medications for reducing discomfort during an Ultherapy treatment.

Detailed description: This trial is a prospective, single-site, double-blinded, randomized trial. All study subjects will receive a full face and neck Ultherapy treatment. Subjects will be randomized to receive one of two pain medications prior to treatment. Each subject will be asked to rate the level of discomfort during the Ultherapy treatment. All study subjects will be followed for 90 days following treatment.

Eligibility criteria: Inclusion Criteria:

* Male or female, aged 30 to 65 years
* Subject in good health
* Skin laxity on the upper and lower face and neck
* Understands and accepts the obligation not to undergo any other procedures in the areas to be treated through the followup period

Exclusion Criteria:

* Known sensitivity to ibuprofen, acetaminophen, or opiates
* Presence of an active systemic or local skin disease that may affect wound healing
* Severe solar elastosis
* Excessive subcutaneous fat in the face and neck
* Excessive skin laxity on the face and neck
* Significant scarring in areas to be treated
* Significant open facial wounds or lesions
* Severe or cystic acne on the face
* Presence of a metal stent or implant in the facial area to be treated

Primary outcomes:
measure: Treatment discomfort
timeFrame: During treatment
Secondary outcomes:
measure: Improvement in skin laxity
timeFrame: 90 days following treatment
Other outcomes:
Locations:
city: Rockville
country: United States
facility: Dermatology, Cosmetic & Laser Surgery
state: Maryland
Study officials:
affiliation: Dermatology, Cosmetic & Laser Surgery
name: Hema Sundaram, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03651973: Prevention of Sequelae Pain After Breast Cancer Surgery by Self-massages and Self Stretching. Impact of Learning Workshops.
Official title: Prevention of Sequelae Pain After Breast Cancer Surgery by Daily Self Massages and Self Stretching of Serratus Anterior Muscle, Pectoralis Major Muscle, Infraspinatus Muscle and Latissimus Dorsi Muscle: Impact of Learning Workshops Performed by a Multidisciplinary Team.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Breast Cancer
Surgery
Keywords: Self massages and self stretching
Workshops for self massages and stretching learning
Lead sponsor: Center Eugene Marquis
Sponsor class: OTHER
First posted: 2018-08-29
Enrollment: 144
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Myofascial pain syndrome is a common cause of chronic pain characterized by myofascial pain and trigger points. Recommendations regarding management of pain after breast cancer don't mention myofascial syndrome despite a study suggests possible myofascial syndrome with roughly 75% of patients in pain.

144 patients having a local breast cancer requiring surgery will be randomized in this study, ratio 1:1 standard and experimental groups.

Every patients (standard and experimental groups) will attend 4 specific consultations during which standard recommendations will be given, pain, quality of life, shoulder range of motion, global upper limbs force will be assessed.

In addition, patient randomized in experimental group will attend self massages and self stretching workshops, one before surgery and one after surgery. Patients will be encouraged to performed daily self massages and self stretching.

The aim of the study is to assess impact of self massages and self stretching workshops on sequelae pain further surgery for breast cancer.


Eligibility criteria: Inclusion Criteria:

* Woman
* Local development of breast cancer, every stages except stage IV
* Indication of surgery whatever surgery type except breast reconstruction
* More than18 years
* Life expectancy \> 12 months assessed by surgeon or pain specialist
* Informed and written consent
* Affiliated to a social security system

Exclusion Criteria:

* History of chronic pain
* History of shoulder pain
* Any illness or severe disease, medical or psychiatric, that could prevent the patient to follow study procedures or to give her informed consent, according investigators,
* History of breast surgery
* Pregnant or lactating woman
* Protected adult or deprived of her liberty

Primary outcomes:
measure: Impact of Learning workshops (self massages and self stretching) on sequelae pain after breast cancer surgery
timeFrame: For 12 months after surgery
Secondary outcomes:
measure: Impact of patient quality of life
timeFrame: at 3, 6 and 12 months
Other outcomes:
Locations:
city: Rennes
country: France
facility: Centre Eugène Marquis
Study officials:
affiliation: Centre Eugène Marquis
name: Aurélie THEBAULT
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05063773: Novel Wireless Mixed Reality Headset for Image Guidance in Cardiac Catheterization Laboratory
Official title: Novel Wireless Mixed Reality Headset for Image Guidance in Cardiac Catheterization Laboratory
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Radiation Injuries
Lead sponsor: SG Devices LLC
Sponsor class: INDUSTRY
Collaborators: name: National Institutes of Health (NIH)
name: University of Minnesota
First posted: 2021-10-01
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: randomized controlled
Primary purpose: PREVENTION

Brief summary: Our hypothesis is that improved line of sight to patient data, ergonomics, and headset lead shielding in the CCL will lead to behavioral changes in the CCL personnel that will reduce radiation exposure to all members of the team. Further, reducing the burden of large, cumbersome monitors will enable improved use of shielding. Our approach is a single center randomized controlled trial of consecutive patients randomly assigned to one of two groups with group 1 using mixed reality display and group 2 using standard 2D displays to perform diagnostic angiography in the CCL. Radiation exposure will be evaluated at multiple levels including total radiation exposure, exposure of each individual staff member, as well as specific exposure to eyes and head in group 1 versus group 2.


Eligibility criteria: Inclusion Criteria:

* undergoing diagnostic coronary angiography

Exclusion Criteria:

* acute coronary syndrome, cardiogenic shock, cardiac arrest, planned intervention

Primary outcomes:
measure: Radiation exposure to the physician
timeFrame: up to 24 months
Secondary outcomes:
measure: radiation exposure to the patient and medical staff
timeFrame: up to 24 months
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01096173: Determination of the in Vitro Effects of Cationic Airway Lining Modulators (CALM) on Chronic Obstructive Pulmonary Disease (COPD) Sputum
Official title: Determination of the in Vitro Effects of CALM on COPD Sputum
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: Sputum
chronic obstructive pulmonary disease
Lead sponsor: Pulmatrix Inc.
Sponsor class: INDUSTRY
Collaborators: name: The VA Western New York Healthcare System
name: Buffalo Institute For Medical Research
First posted: 2010-03-30
Enrollment: 10
Sex: ALL
Minimum age (years): 35
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Outpatient clinic setting

Brief summary: This study is intended to be an evaluation of the properties of human sputum collected from patients with COPD. It is hypothesized that cationic airway lining modulators will have beneficial effects on the rheological properties of sputum derived from patients with COPD. Approximately 10 patients with COPD will collect sputum at home for 5 days. Samples will be collected and tested in laboratory tests.


Eligibility criteria: Inclusion Criteria:

1. Clinical and spirometric diagnosis of COPD
2. Smoking history of at least 10 pack yrs
3. Sputum production of greater than 2 tablespoons per day by patient report.

Exclusion Criteria:

1. a primary diagnosis of asthma or bronchiectasis
2. a COPD exacerbation within 4 weeks
3. Inability to comply with study procedures.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Buffalo
country: United States
facility: VA WNY Healthcare System
state: New York
Study officials:
affiliation: Va Western NY Healthcare, Buffalo Institute for Medical Research
name: Sanjay Sethi, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00404573: Study Evaluating RGH-188 in the Treatment of Patients With Schizophrenia
Official title: A Double-Blind, Placebo-Controlled Evaluation of the Safety and Efficacy of RGH-188 in the Acute Exacerbation of Schizophrenia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Schizophrenia
Keywords: Schizophrenia
Lead sponsor: Forest Laboratories
Sponsor class: INDUSTRY
First posted: 2006-11-29
Enrollment: 375
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: This is a study designed to evalute the safety and efficacy of RGH-188 in the treatment of acute schizophrenia. This study will be 10 weeks in duration; 6 weeks double-blind treatment, and 4 weeks safety follow-up. All patients meeting the eligibility criteria will be randomized to one of the three treatment groups--one of two doses of RGH-188 or placebo


Eligibility criteria: Inclusion Criteria:

* Male and female inpatients, 18-65 years of age, meeting DSM-IV-TR criteria for schizophrenia and having a Total Positive and Negative Syndrome Scale (PANSS) Score \>=80 and \<=120. A score \>=4 on item P1 (delusions) or P3 (hallucinatory behavior) and a score of \>=4 on item P2 (conceptual disorganization) or P6 (suspiciousness/persecution) of the PNASS

Exclusion Criteria:

* Patients with documented disease of the central nervous system that can interfere with the trial assessments, including but not limited to stroke, tumor, Parkinson's, organic brain disease, seizure disorder (except for febrile convulsions during infancy), chronic infection, or neurosyphilis; or patients who have suffered a traumatic brain injury resulting in significant impairment

Primary outcomes:
measure: PANSS Total Score
Secondary outcomes:
measure: CGI-S
Other outcomes:
Locations:
city: St Louis
country: United States
facility: For information regarding investigative sites, contact Forest Professional Affairs
state: Missouri
Study officials:
References:
citation: Laszlovszky I, Barabassy A, Nemeth G. Cariprazine, A Broad-Spectrum Antipsychotic for the Treatment of Schizophrenia: Pharmacology, Efficacy, and Safety. Adv Ther. 2021 Jul;38(7):3652-3673. doi: 10.1007/s12325-021-01797-5. Epub 2021 Jun 6.
citation: Barabassy A, Sebe B, Acsai K, Laszlovszky I, Szatmari B, Earley WR, Nemeth G. Safety and Tolerability of Cariprazine in Patients with Schizophrenia: A Pooled Analysis of Eight Phase II/III Studies. Neuropsychiatr Dis Treat. 2021 Apr 7;17:957-970. doi: 10.2147/NDT.S301225. eCollection 2021.
citation: Earley W, Durgam S, Lu K, Laszlovszky I, Debelle M, Kane JM. Safety and tolerability of cariprazine in patients with acute exacerbation of schizophrenia: a pooled analysis of four phase II/III randomized, double-blind, placebo-controlled studies. Int Clin Psychopharmacol. 2017 Nov;32(6):319-328. doi: 10.1097/YIC.0000000000000187.
Clinical trial NCT03696173: Safety Study of Abatacept in Rheumatoid Arthritis Participants
Official title: Comparative Safety of Biologic Disease-modifying Treatment Initiation With Abatacept in Rheumatoid Arthritis: A Real-world Population-based Observational Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rheumatoid Arthritis
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2018-10-04
Enrollment: 5800
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Rheumatoid arthritis (RA) participant, population-based cohort study approach within the US-based Truven MarketScan population and Supplemental US Medicare database

Brief summary: A observational study to assess whether biologic disease-modifying (BDM) treatment initiation with abatacept for rheumatoid arthritis is associated with an increased risk of serious infection and cancer


Eligibility criteria: Inclusion Criteria:

* Patient initiates BDM treatment with at least one claim for the treatment. Patients will be presumed to be new users of a treatment if there is no claim for the drug or any other BDM in the 180 days prior to the cohort entry date
* Patient has at least two diagnoses for RA in the patient's history prior to and including the entry date or within the 180 days after the entry date
* Patient is aged 18 years or older on the entry date
* Patient was enrolled in the database for at least 180 days before the entry date

Exclusion Criteria:

* Patient is younger than 18 years on the entry date
* Patients who receive abatacept and another biologic simultaneously
* Patients who have an outcome diagnosis in the baseline period will be excluded from the cohort analyses for that outcome

Other protocol defined inclusion/exclusion criteria could apply

Primary outcomes:
measure: Incidence of increased risk of serious infection while taking abatacept
timeFrame: Approximately 7 years
measure: Incidence of malignancy while taking abatacept
timeFrame: Approximately 7 years
measure: Incidence of increased risk of serious infection while taking abatacept
timeFrame: Approximately 7 years
measure: Incidence of malignancy while taking abatacept
timeFrame: Approximately 7 years
Secondary outcomes:
Other outcomes:
Locations:
city: Princeton
country: United States
facility: Local Institution
state: New Jersey
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References:
Clinical trial NCT00951873: A Single Dose Trial Investigating Safety and Local Tolerability of Ascending Doses of Long Acting Activated Recombinant Human Factor VII in Healthy Male Volunteers
Official title: A Single-centre, Randomised, Placebo-controlled, Double-blind Single Dose, Dose Escalation Trial Investigating Safety, Pharmacokinetics and Local Tolerability of Ascending Subcutaneous Doses of Long Acting-rFVIIa in Healthy Male Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Congenital Bleeding Disorder
Haemophilia A
Haemophilia B
Healthy
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2009-08-04
Enrollment: 38
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This trial is conducted in Europe. The aim of this clinical trial is to investigate the safety, local tolerability and pharmacokinetic profile (the determination of the concentration of the administered medication in blood over time) of long acting activated recombinant human factor VII when injected subcutaneously (under the skin).


Eligibility criteria: Inclusion Criteria:

* Caucasian origin
* Body weight between 50 and 100 kg and a Body Mass Index (BMI) between 18.0 and 28.0 kg/m2 inclusive
* Smoke less than 10 cigarettes/day or equivalent and willingness to abstain from smoking during the entire duration of Trial Product Administration (9 days)

Exclusion Criteria:

* Known or suspected allergy to trial product or related products, such as activated recombinant human factor VII (NovoSeven®)
* Previous participation in this trial, defined as randomised to receive trial product
* Evidence of clinically relevant pathology or potential thromboembolic risk as judged by the Investigator
* Known history of atherosclerosis or thromboembolic events
* Overt bleeding, including from gastrointestinal tract
* Hepatitis B or C infection
* HIV infection
* Positive test for drugs of abuse

Primary outcomes:
measure: Number of adverse events
timeFrame: assessed throughout the trial period from visit 1 to visit 5
Secondary outcomes:
measure: Area under activity concentration-time curve from time zero to infinity
timeFrame: assessed up to 168 hours after trial product administration
Other outcomes:
Locations:
city: Harrow
country: United Kingdom
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References:
Clinical trial NCT02600273: Novel Approaches to Reducing Tobacco Related Harm
Official title: Novel Approaches to Reducing Tobacco Related Harm Among HIV-Infected Smokers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Smoking
Tobacco Smoking Behavior
Cigarette Smoking
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: National Institute of Allergy and Infectious Diseases (NIAID)
First posted: 2015-11-09
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: The purpose of this study is to assess initial reactions to alternative nicotine/tobacco products among smokers living with HIV.

Detailed description: Participants will sample 4 alternative nicotine/tobacco products and provide initial reactions to the products.

Eligibility criteria: Inclusion Criteria:

1. HIV-infected adults age 18 and older currently receiving HIV care
2. Self-report smoking ≥10 cigarettes/day of a brand delivering \>0.5mg nicotine for \>2yrs
3. Have afternoon expired CO concentrations of ≥10ppm or morning urinary cotinine \>100ng/ml (as measured with NicAlert)

Exclusion Criteria:

1. Impaired mental status as assessed by observation
2. Acute intoxication as measured by breath alcohol level (BAL) \> 0
3. Current use of nicotine replacement or other pharmacotherapy for smoking cessation
4. Previous use of e-cigarettes
5. Use of other tobacco products (e.g., chew tobacco, cigars) on \> 10 of the past 30 days
6. Unstable HIV or associated comorbidities, as determined by a licensed medical professional.
7. Pregnancy (Females testing positive for pregnancy and any participants wishing to quit immediately will be referred to community smoking cessation treatment and will be excluded from the study)
8. Blood pressure at or above 160/100 or below 90/50
9. Heart rate at or above 105 bpm or below 45 bpm

Primary outcomes:
measure: Subjective effects, as measured by survey
timeFrame: within 2 minutes after sampling product(s)
measure: Risk perceptions, as measured by survey
timeFrame: Before and within 2 minutes after sampling product(s)
measure: Interest and confidence in quitting, as measured by survey
timeFrame: within 2 minutes after sampling product(s)
Secondary outcomes:
measure: Reinforcing properties of product(s), as measured by survey
timeFrame: within 2 minutes after sampling product(s)
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University School of Medicine
state: North Carolina
Study officials:
affiliation: Duke University
name: F. Joseph McClernon, PhD
role: PRINCIPAL_INVESTIGATOR
References: