louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01030003: Snoring in Pregnancy and Adverse Maternal and Fetal Outcomes
Official title: The Impact of Sleep-Disordered Breathing on Adverse Pregnancy Outcomes
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sleep Apnea Syndromes
Keywords: Sleep-Disordered Breathing
Snoring
Pregnancy
Fetal Growth Retardation
Pre-Eclampsia
Lead sponsor: University of Michigan
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2009-12-10
Enrollment: 1685
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Eligible pregnant women are those receiving prenatal care and planning on delivering at the University of Michigan.

Brief summary: The purpose of the study is to determine the prevalence of sleep-disordered breathing in pregnant women during the third trimester of pregnancy and to investigate whether this is associated with high blood pressure in the mother and/or growth retardation in the baby.


Eligibility criteria: Inclusion Criteria:

* Women attending obstetric clinics at University of Michigan Hospitals.
* Willing and able to provide informed consent.
* Aged 18 years or older

Exclusion Criteria:

* Aged under 18 years

Primary outcomes:
measure: Maternal diagnosis of hypertension
timeFrame: 0-3 months after enrollment.
Secondary outcomes:
measure: Infant birth centile
timeFrame: 0-3 months after enrollment.
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
Study officials:
affiliation: University of Michigan
name: Louise M O'Brien, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: O'Brien LM, Bullough AS, Owusu JT, Tremblay KA, Brincat CA, Chames MC, Kalbfleisch JD, Chervin RD. Snoring during pregnancy and delivery outcomes: a cohort study. Sleep. 2013 Nov 1;36(11):1625-32. doi: 10.5665/sleep.3112.
Clinical trial NCT01388803: The Depth of Right Bronchial Blocker Placement in Taiwanese in Video-assisted Thoracoscopic Surgery(VATS)
Official title: Right Side Bronchial Blocker in Video-assisted Thoracoscopic Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lung Tumor
Pneumothorax
Keywords: bronchial blocker
VATS
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2011-07-07
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 77
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients receiving right side VATS( video-assisted thoracoscopic surgery) with right side bronchial blocker

Brief summary: A retrospective study to demonstrate the optimal depth of right side bronchial blocker for complete right lung separation. Data were collected from all patients who completed right side VATS with right side BB from Jan 2010 through Nov 2010.

Detailed description: After general anesthesia, an 8.0 mm internal-diameter single-lumen endotracheal tube was inserted orally. An independent Coopdech bronchial blocker, which has a formed-curvature near the catheter tip, was directly inserted through the single-lumen endotracheal tube into right main bronchus. Chest inspection, auscultation, fiberoptic bronchoscopy confirmation, if necessary, by visualizing the blocker cuff located at right main bronchus just below the carina was performed firstly. After placing patients in left decubitus position, the position of BB was reconfirmed by auscultation firstly; then complete collapse of the right upper lobe was adjust, if necessary and reconfirmed on the video of thoracoscopy by both surgeon and anesthesiologists. The depth of BB and the need of fiberoptic bronchoscope were recorded. All the patients were extubated in operation room after completion of operation with optimal analgesia. Data collected included; age, sex, body height and weight and the depth of right-sided BB from incisor was then recorded.

Eligibility criteria: Inclusion Criteria:

* Patients receiving right side VATS( video-assisted thoracoscopic surgery) with right side bronchial blocker

Exclusion Criteria:

* Patients receiving thoracic surgery with double lumen tubes

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
affiliation: deaprtment of anesthesiology, national taiwan university hospital
name: ya-jung cheng, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT00002303: The Safety and Effectiveness of r-HuEPO in Patients With AIDS or Advanced AIDS-Related Complex (ARC) Who Are Anemic
Official title: A Double-Blind, Placebo-Controlled Study With Open-Label Follow-Up To Determine the Safety and Efficacy of r-HuEPO in Patients With AIDS or Advanced ARC and Anemia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV Infections
Cytopenias
Keywords: Recombinant Proteins
Erythropoietin
Acquired Immunodeficiency Syndrome
Anemia
AIDS-Related Complex
Zidovudine
Lead sponsor: NIH AIDS Clinical Trials Information Service
Sponsor class: INDUSTRY
First posted: 2001-08-31
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: To determine the safety and efficacy of erythropoietin administered to patients with AIDS or advanced AIDS related complex ARC and anemia.


Eligibility criteria: Exclusion Criteria

Co-existing Condition:

Patients with the following are excluded:

* History of any primary hematologic disease.
* Clinically significant disease / dysfunction of the pulmonary, cardiovascular, endocrine, neurologic, gastrointestinal, or genitourinary systems not attributable to underlying HIV disease.
* AIDS-related dementia.
* Uncontrolled hypertension (diastolic blood pressure \> 100 mmHg).
* Presence of concomitant iron deficiency.
* Anemia attributable to factors other than AIDS or zidovudine (AZT) therapy.
* Acute opportunistic infection.
* History of seizures.

Concurrent Medication:

Excluded:

* Zidovudine (AZT) during the double-blind phase of the study.

Patients with clinically significant disease / dysfunction of the pulmonary, cardiovascular, endocrine, neurologic, gastrointestinal, or genitourinary systems not attributable to underlying AIDS are excluded.

Prior Medication:

Excluded within 30 days of study entry:

* Experimental drug or experimental device.
* Cytotoxic chemotherapy.
* Excluded within 2 months of study entry:
* Androgen therapy.
* Zidovudine (AZT) and during double-blind phase of study.

Clinical diagnosis of AIDS related anemia.

* Clinical diagnosis of AIDS or advanced AIDS related complex (ARC).
* Clinically stable for 1 month preceding study entry.

Substance abuse.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Raritan
country: United States
facility: Ortho Pharmaceutical Corp
state: New Jersey
Study officials:
References:
Clinical trial NCT05182203: Safety and Retention Rate of the JAK and TNF Inhibitors in Rheumatoid Arthritis: a Real-life Experience
Official title: Safety and Retention Rate of the JAK and TNF Inhibitors in Rheumatoid Arthritis: a Real-life Experience
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rheumatoid Arthritis
Drug Use
Keywords: rheumatoid arthitis
biological agents
targeted agents
Lead sponsor: Tuen Mun Hospital
Sponsor class: OTHER_GOV
First posted: 2022-01-10
Enrollment: 1732
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Diagnosis of RA Ever received treatment with any biologic/targeted DMARDs data entered into our Biologics registry age \>=18 years

Brief summary: This study aims to extract data from the Hong Kong Biologics Registry for retention rate of the JAK inhibitors in rheumatoid arthritis and review other adverse events by looking at the medical record retrospectively. These real life data are important as they cannot be provided by randomized controlled trials which are limited by the duration of observation and fixed protocols in research settings. Moreover, data will represent our local experience of the JAK inhibitors in Chinese patients with RA. The retention rate and adverse effects of the JAK inhibitors are compared with conventional TNF inhibitors.

Detailed description: This study aims to extract data from the Hong Kong Biologics Registry for retention rate of the JAK inhibitors in rheumatoid arthritis and review other adverse events by looking at the medical record retrospectively. Efficacy data and adverse events, in particular major adverse cardiovascular events (MACEs) and malignancy will be looked at and compared with the TNF inhibitors. Retention / withdrawal rates of the drugs will be studied by statistical analyses.

Eligibility criteria: Inclusion Criteria:

* All RA patients in our biologics registry treated with the JAK inhibitors (N=411)
* All RA patients in our biologics registry treated with the TNF inhibitors (N=1392)

Exclusion Criteria:

- RA patients in our biologics registry treated with other biologic/targeted DMARDs

Primary outcomes:
measure: Withdrawal rate due to major / serious adverse events
timeFrame: from start of biologic/targeted DMARD use to these event(s) up to 10 years
Secondary outcomes:
measure: Withdrawal rate due to inefficacy
timeFrame: from start of biologic/targeted DMARD use to last clinic visit up to 10 years
Other outcomes:
Locations:
city: Hong Kong
country: China
facility: Department of Medicine, Tuen Mun Hospital
Study officials:
affiliation: Tuen Mun Hospital
name: Chi Chiu Mok, MD, FRCP
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01127503: Metyrosine (Demser®) for the Treatment of Psychotic Disorders in Patients With Velocardiofacial Syndrome
Official title: A Double-Blind, Placebo-Controlled, Multi-Center, Randomized Trial of the Safety and Efficacy of Metyrosine (Demser®) for the Treatment of Psychotic Disorders in Patients With Velo-Cardio-Facial Syndrome
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Velo-cardio-facial Syndrome
Psychosis
Keywords: Patients with velocardiofacial syndrome and psychosis
Lead sponsor: Bausch Health Americas, Inc.
Sponsor class: INDUSTRY
First posted: 2010-05-21
Enrollment: 2
Sex: ALL
Minimum age (years): 16
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is an exploratory clinical investigation. The objectives of this study are to evaluate the safety, steady-state pharmacokinetics, and efficacy of metyrosine (Demser®) for the treatment of psychosis in patients with velocardiofacial syndrome (VCFS).


Eligibility criteria: Key Inclusion Criteria:

1. Females of childbearing potential cannot be at risk of pregnancy during the study.
2. Genetically confirmed diagnosis of VCFS at the time of screening.
3. Must have one of the following Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition Text Revision (DSM-IV TR) diagnoses (applicable based upon clinical assessments): schizophrenia, schizoaffective disorder, psychosis not otherwise specified (NOS), bipolar disorder, or mood disorder with psychotic features.
4. A total PANSS composite score \>65.
5. Willing to discontinue psychotropic medications. -

Key Exclusion Criteria:

1. Evidence of acute suicidality.
2. Known or observed clinically significant cardiovascular, pulmonary, renal, hepatic, or gastrointestinal disorders; other clinically significant psychiatric/neurological and sleep disorders by DSM-IV-TR criteria; endocrine, or hematological or metabolic diseases.
3. Full scale IQ of less than 50.
4. Pregnancy.
5. Not using a reliable means of contraception.
6. Systolic blood pressure of ≤110 mm/Hg or ≥160 mm/Hg, diastolic blood pressure ≤60 mm/Hg or ≥90 mm/Hg, or has clinically symptomatic orthostatic changes.
7. QTcF \> 450 msec, or PR \> 250 msec, or QRS \> 110 msec on ECG.
8. History of seizure disorder. -

Primary outcomes:
measure: To Evaluate the Safety of Metyrosine (Demser®) for the Treatment of Psychosis in Patients With VCFS
timeFrame: 13 weeks
Secondary outcomes:
measure: To Evaluate the Efficacy of Metyrosine (Demser®) for the Treatment of Psychosis in Patients With VCFS
timeFrame: 13 weeks
Other outcomes:
Locations:
city: Syracuse
country: United States
facility: VCFS International Center
state: New York
Study officials:
affiliation: Upstate Medical University
name: Robert J Shprintzen, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04498403: A Study of the Long-Term Safety of Crisaborole Ointment, 2% in Japanese Pediatric and Adult Participants With Mild to Moderate Atopic Dermatitis
Official title: A PHASE 3, MULTICENTER, OPEN-LABEL STUDY OF THE LONG-TERM SAFETY OF CRISABOROLE OINTMENT, 2% IN JAPANESE PEDIATRIC AND ADULT PARTICIPANTS WITH MILD TO MODERATE ATOPIC DERMATITIS
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Atopic Dermatitis
Keywords: Eczema
Crisaborole
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2020-08-04
Enrollment: 40
Sex: ALL
Minimum age (years): 7
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study is a Phase 3, multicenter, open-label, long-term safety extension study of Studies C3291032 and C3291031 in Japanese pediatric and adult participants with mild to moderate Atopic Dermatitis (AD).


Eligibility criteria: Inclusion Criteria:

* Male or female participants;
* Who were patients with mild to moderate AD aged 2 years old or older and met eligibility criteria for study C3291032 at the time when entering Study C3291032, and completed treatment period in Study C3291032 without safety issues. Or
* Who were patients with mild to moderate AD aged 1 months to \<24 months and met eligibility criteria for Study C3291031 at the time when entering Study C3291031, and completed treatment period in Study C3291031 without safety issues

Exclusion Criteria:

* Has other medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study.

Primary outcomes:
measure: Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
timeFrame: Baseline up to 28 days after last dose of study drug (maximum up to 12 weeks)
Secondary outcomes:
Other outcomes:
Locations:
city: Hiroshima-shi
country: Japan
facility: Shirao Clinic of Pediatrics and Pediatric Allergy
state: Hiroshima
city: Chitose Shi
country: Japan
facility: Chitose dermatology and plastic surgery clinic
state: Hokkaido
city: Obihiro
country: Japan
facility: Takagi Dermatological Clinic
state: Hokkaido
city: Akashi-City
country: Japan
facility: Yoshimura Child Clinic
state: Hyōgo
city: Kobe-City
country: Japan
facility: Iryouhoujinshadan Yamayurikai Tsujino. Kodomo Clinic
state: Hyōgo
city: Kamimashiki-gun
country: Japan
facility: Noguchi Dermatology Clinic
state: Kumamoto
city: Neyagawa
country: Japan
facility: Yoshioka Dermatology Clinic
state: Osaka
city: Adachi-ku
country: Japan
facility: Mildix Skin Clinic
state: Tokyo
city: Setagaya-ku
country: Japan
facility: Yoga Allergy Clinic
state: Tokyo
city: Toshima-Ku
country: Japan
facility: Sugamo Kobayashi Derma Clinic
state: Tokyo
city: Fukuoka
country: Japan
facility: Hoshikuma Dermatology・Allergy Clinic
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT01898403: Lymph Node Mapping Using Indocyanine Green Solution in Diagnosing Patients With Malignant Melanoma
Official title: Testing the Efficacy of Indocyanine Green Imaging (ICG-SPY) in the Identification of Sentinel Lymph Nodes (SLN) in Patients With Malignant Melanoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Recurrent Melanoma
Lead sponsor: Stanford University
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2013-07-12
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: This clinical trial compares and contrasts lymph node mapping using indocyanine green (IC-GREEN), isosulfan blue (ISB), and TSC and Lymphoscintigraphy with 99-technetium (99Tc) sulfur colloid (TSC).

Study participants with malignant melanoma will undergo all 3 evaluations to assess the extent of the spread of the melanoma.

Detailed description: PRIMARY OBJECTIVES:

I. To show that indocyanine green (ICG) (indocyanine green solution) is equal to both isosulfan blue (ISB) and technetium Tc 99m sulfur colloid (TSC) and will allow all lymph node mapping to occur in the operating room (OR).

OUTLINE:

Patients receive peri-tumoral, intradermal injections of isosulfan blue and indocyanine green solution. During surgery, patients undergo identification of the sentinel lymph node and imaging using a laser with videocamera (SPY Elite camera).

Eligibility criteria: Inclusion Criteria:

* Ability to understand and willingness to sign informed consent document
* Signed written informed consent
* Malignant melanoma (MM) undergoing sentinel lymph node biopsy (SNLB)
* 18 years of age or older
* Complete blood count (CBC) and metabolic panel within 6 months

Exclusion Criteria:

* History of hepatic or renal failure
* Allergy to iodine containing products
* Pregnant or may be pregnant
* Psychiatric or addictive disorders that in the opinion of the research team, may not be able to meet study requirements
* Undergoing dialysis

Primary outcomes:
measure: Sentinel Lymph Nodes (SLN) Mapping
timeFrame: Up to 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University Hospitals and Clinics
state: California
Study officials:
affiliation: Stanford University Hospitals and Clinics
name: Ralph Greco
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00161603: Cornell Translational Behavioral Science Research Consortium: Angioplasty Qualitative Study
Official title: Cornell Translational Behavioral Science Research Consortium: Angioplasty Qualitative Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Angioplasty Patients
Keywords: Angioplasty
Behavior change
Physical activity
Risk reduction
Lead sponsor: Weill Medical College of Cornell University
Sponsor class: OTHER
First posted: 2005-09-12
Enrollment: 18
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE

Brief summary: To explore and illuminate the cultural, social, and psychological factors that either facilitate or serve as barriers to behavioral change in angioplasty patients. Through a series of open-ended questions we will explore and build a better understanding of how culturally different patient groups perceive heart disease and the difficulties in changing health behavior. In addition, we hope to better understand and anticipate barriers and issues that participants face in successfully changing their behaviors.

Detailed description: 1. To explore and illuminate the cultural, social, and psychological factors that either facilitate or serve as barriers to behavioral change in angioplasty patients. Through a series of open-ended questions we will explore and build a better understanding of how culturally different patient groups perceive heart disease and the difficulties in changing health behavior. In addition, we hope to better understand and anticipate barriers and issues that participants face in successfully changing their behaviors.
2. To use the responses obtained in the qualitative interviews to inform how we should operationalize and tailor the positive affect induction and self-affirmation intervention methods in each of the populations under study. Specifically, this involves assessing what small gifts participants prefer to receive and what would be most effective in inducing positive affect.

Eligibility criteria: Inclusion Criteria:

* Post-angioplasty patients who had previously participated in an RCT designed to motivate multi-behavior change.

Exclusion Criteria:

* Patients who refuse to be interviewed, Patients who were not enrolled in the parent trial

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: The New York Presbyterian Hospital-Weill Medical Center
state: New York
Study officials:
affiliation: Weill Medical College of Cornell University
name: Mary E Charlson, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Janey C. Peterson, RN, MA, Paul A. Pirraglia, MD, Sung Lee, MD, Laura Robbins, DSW, John P. Allegrante, PhD and Mary E. Charlson, MD. Living with heart disease: A qualitative study. Annals of Behavioral Medicine; 29(Supp), p. 28. April 14, 2005, Boston, MA.
Clinical trial NCT03704103: mHealth Insulin Titration and Management (iSage)
Official title: mHealth Insulin Titration and Management (iSage)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 2 Diabetes Mellitus
Lead sponsor: University of Kansas Medical Center
Sponsor class: OTHER
First posted: 2018-10-12
Enrollment: 6
Sex: ALL
Minimum age (years): 21
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 the benefits of using the iSage app for basal insulin titration and support. By doing this study the investigators hope to learn whether the app improves the participant's ability to follow his/her healthcare provider's instructions to adjust his/her insulin doses.


Eligibility criteria: Inclusion Criteria:

* Diagnosed Type 2 Diabetes, based on the World Health Organization (WHO) criteria, treated with basal insulin
* HbA1c 8-11% inclusive
* Glomerular filtration rate (GFR) \> 60 ml/min
* Has an Android or iOS based compatible smartphone (iOS 9.0 or above, Android 4.4 or above)
* Willing to perform at least 1 fasting finger stick glucose measurements every morning
* English speaking

Exclusion Criteria:

* Diagnosis of hypoglycemic unawareness
* Diagnosis of hyperglycemic hyperosmolar non-ketotic coma (HONK) or diabetic ketoacidosis (DKA) within 6 months of enrollment
* Recent (within the last 6 months)/current use of non-topical steroids
* Insulin requirements in excess of 1 U/kg per day
* Use of pioglitazone or another thiazolidinedione (TZD)
* In the opinion of the provider, HgbA1c goals should be adjusted above 7% due to infirmity, unstable cardiovascular disease, etc.

Primary outcomes:
measure: Concentration of HgbA1c
timeFrame: 90 days
measure: Number of participants meeting HgbA1c <7%
timeFrame: 90 days
Secondary outcomes:
measure: Sustained use of the iSage app (iSage group only)
timeFrame: 90 days
measure: Hypoglycemia
timeFrame: 90 days
Other outcomes:
measure: Healthcare resource utilization
timeFrame: 90 days
measure: Diabetes Quality of Life Survey (DQOL)
timeFrame: 90 days
measure: Insulin Treatment Satisfaction Questionnaire (ITSQ)
timeFrame: 90 days
measure: iSage Product Satisfaction Survey (iSage group only)
timeFrame: 90 days
Locations:
city: Kansas City
country: United States
facility: University of Kansas Medical Center
state: Kansas
Study officials:
References: