louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00385177: Phase 1 Dose Escalation Study of SN2310 Injectable Emulsion in Patients With Advanced Solid Tumors
Official title: A Multicenter Phase 1 Dose Escalation Study of SN2310 Injectable Emulsion in Patients With Advanced Solid Tumors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Breast Neoplasms
Colorectal Neoplasms
Pancreatic Neoplasms
Pelvic Neoplasms
Lung Neoplasms
Lead sponsor: Achieve Life Sciences
Sponsor class: INDUSTRY
First posted: 2006-10-06
Enrollment: 61
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a Phase 1 open-label study of SN2310 Injectable Emulsion in patients with advanced solid malignancies. The study is designed to determine the maximum tolerated dose and dose-limiting toxicity of SN2310 Injectable Emulsion, and to characterize the pharmacokinetics of SN2310 and SN-38 following intravenous administration of SN2310 Injectable Emulsion. Additionally, evaluation of side effects as a function of dose, and observation of any anti-tumor effects of SN2310 Injectable Emulsion will be made.

Detailed description: This is a Phase 1 open-label study of SN2310 Injectable Emulsion in patients with advanced solid malignancies who have failed conventional therapy. SN2310 Injectable Emulsion will be administered intravenously every 21 days. The study is designed to determine the maximum tolerated dose and dose-limiting toxicity of SN2310 Injectable Emulsion; to characterize the pharmacokinetics of SN2310 and SN-38 following intravenous administration of SN2310 Injectable Emulsion; to evaluate side effects as a function of dose level; and, to observe any anti-tumor effects of SN2310 Injectable Emulsion.

Eligibility criteria: Inclusion Criteria:

* Histologically or cytologically confirmed diagnosis of solid tumor with disease progression despite standard therapy and/or for which no other solid therapeutic option exists
* ANC \> 1,500 cell/mm3, platelets \> 100,000/mm3 and Hgb \> 9 g/dl
* At least one unidimensionally measurable lesion per RECIST
* Negative serum or urine pregnancy test, if female of childbearing potential

Exclusion Criteria:

* Female who is pregnant or lactating
* History of chronic diarrhea

Primary outcomes:
measure: Maximum Tolerated Dose
timeFrame: December 2008
measure: Dose-Limiting Toxicity
timeFrame: December 2008
measure: Adverse Events
timeFrame: December 2008
measure: Pharmacokinetic parameters for SN2310 and SN-38
timeFrame: December 2008
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Fox Chase Cancer Center
state: Pennsylvania
city: Nashville
country: United States
facility: Sarah Cannon Research Institute
state: Tennessee
Study officials:
References:
Clinical trial NCT02947477: Emotion Tracking Study for Residents
Official title: EmoTrak, Ecological Momentary Assessment of Emotion, Stress and Satisfaction Among Residents
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stress, Emotional
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
First posted: 2016-10-28
Enrollment: 100
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The proposed study will develop and pilot a fourteen-day assessment tailored for the high-demand schedule of residents through a smart phone intervention, EmoTrak.EmoTrak uses ecological measurement assessment (EMA), which solicits real-time user feedback at various time points across a series of days or weeks.

Detailed description: The investigators will perform a randomized controlled trial that compares residents, using EmoTrak with a wait list control group. After two weeks, the active control group becomes the treatment group. All participants will be evaluated four times from at baseline to two months. The measures to explore for any pre and post change are stress reduction on the emotional exhaustion scale of the Maslach Burnout Inventory (MBI) and improved resilience on the Perceived Stress Scale (PSS).

Eligibility criteria: Inclusion Criteria:

* Currently in Residency or Fellowship at UCSF

Exclusion Criteria:

* Not having an Iphone

Primary outcomes:
measure: Retention of Participants Iphone App for Residents
timeFrame: 14 days
measure: Acceptability of Iphone App for Residents Online Evaluation and Mini Interviews
timeFrame: 30 days
Secondary outcomes:
measure: Real Time Assessment Comparison to Standardized Measures
timeFrame: 35 days
measure: Ecological Assessment of Emotions Compared to Standardized Emotion Awareness Measures, PANAS
timeFrame: 14 days
measure: Ecological Assessment of Stress Compared to Standardized Perceived Stress and Emotional Exhaustion from the Maslach Burnout Inventory
timeFrame: 14 days
Other outcomes:
measure: Exploratory Analysis of Reduction in Pre and Post Reported Emotional Exhaustion on the MBI
timeFrame: 30 days
measure: Exploratory Analysis of Reduction in Pre and Post Reported Stress on PSS and MBI
timeFrame: 30 days
measure: Exploratory Analysis of Increase in Pre and Post Reported Resilience on the CDRisc
timeFrame: 30 days
Locations:
city: San Francisco
country: United States
facility: University of California
state: California
Study officials:
affiliation: University of California, San Francisco
name: Eve Ekman, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Riess H, Kelley JM, Bailey RW, Dunn EJ, Phillips M. Empathy training for resident physicians: a randomized controlled trial of a neuroscience-informed curriculum. J Gen Intern Med. 2012 Oct;27(10):1280-6. doi: 10.1007/s11606-012-2063-z. Epub 2012 May 2.
Clinical trial NCT02534077: Intravenous Fat Emulsion Comprised of Fish Oil in the Treatment of Parenteral Nutrition Induced Liver Injury in Infants
Official title: Compassionate Use of an Intravenous Fat Emulsion Comprised of Fish Oil in the Treatment of Parenteral Nutrition Induced Liver Injury in Infants
Study type: EXPANDED_ACCESS
Overall status: APPROVED_FOR_MARKETING
Conditions: Total Parenteral Nutrition-induced Cholestasis
Keywords: omegaven
cholestasis
parenteral nutrition associated liver disease
Lead sponsor: Pediatrix
Sponsor class: OTHER
First posted: 2015-08-27
Sex: ALL
Minimum age (years): 14
Maximum age (years): 2
Standard ages: CHILD
Accepts healthy volunteers: no

Brief summary: To provide a mechanism for critically ill infants with parenteral nutrition (PN) associated cholestasis to receive Omegaven for compassionate use situations for which there are no satisfactory alternative treatments.

Detailed description: Compassionate Use

Eligibility criteria: Inclusion Criteria:

1. Critically ill infants with either a known anatomic short gut (greater than 50% of the bowel removed) or known severe dysmotility of the gut reflecting non-functional gut similar to anatomic short gut will be offered Omegaven® when their direct bilirubin reaches 2 mg/dL. Infants who do not meet the above criteria for anatomic or dysfunctional short gut will be allowed to receive Omegaven® when their direct bilirubin reaches 4 mg/dL. The qualifying measurements of 2 mg/dL or 4 mg/dL direct bilirubin must be consecutive and obtained at least 24 hours apart.
2. Be expected to require intravenous nutrition for at least an additional 28 days
3. Patient must have documented failure of or ineligibility for the following therapies to prevent progression of PNALD:

   * Reduction of Intralipid® to 1 g/kg/day
   * Limiting trace minerals including copper and manganese
   * Initiation and use of Ursodiol
   * Cycling of parenteral nutrition
   * Advancement of enteral feedings
4. Parental informed consent must be signed.

Exclusion Criteria:

1. Have a congenitally lethal condition (e.g. Trisomy 13).
2. Have clinically severe bleeding not able to be managed with routine measures.
3. Have evidence of a viral hepatitis or primary liver disease as the primary etiology of their cholestasis.
4. Have other health problems such that survival is extremely unlikely even if the infant's cholestasis improves.
5. Has culture positive sepsis

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: San Antonio
country: United States
facility: Children's Hospital of San Antonio
state: Texas
Study officials:
affiliation: Pediatrix
name: Kaashif Ahmad, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01318577: Study of A New Contact Lens Cleaning and Disinfecting Solution
Official title: Study of A New Contact Lens Cleaning and Disinfecting Solution
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Vision Disorders
Keywords: Contact lens
Cleaning solution
Lead sponsor: Bausch & Lomb Incorporated
Sponsor class: INDUSTRY
First posted: 2011-03-18
Enrollment: 444
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The objective of this study is to evaluate the safety and efficacy of a new investigational cleaning and disinfecting solution (Test) compared to Clear Care cleaning and disinfecting solution (Control) when used by contact lens wearers to clean and disinfect their contact lenses for approximately three months.


Eligibility criteria: Inclusion Criteria:

* Subjects must be habitual wearers of one of the protocol specified lenses.
* Subjects must habitually use a NON-PEROXIDE lens care product for cleaning, disinfecting and storage of their lenses.
* Subjects must be adapted lens wearers and wear a lens in each eye and each lens must be of the same manufacture and brand.
* Subjects must agree to wear their lenses on a daily wear basis for approximately three months.

Exclusion Criteria:

* Subjects who currently use a hydrogen peroxide cleaning and disinfecting solution.
* Subjects who currently wear Opaque Cosmetic Tint Contact Lenses.
* Subjects who have worn polymethylmethacrylate (PMMA) lenses within the last three months.
* Subjects with any systemic disease currently affecting ocular health or which in the Investigator"s opinion may have an effect on ocular health during the course of the study.
* Subjects using any systemic or topical medications that will, in the Investigator"s opinion, affect ocular physiology or lens performance.
* Subjects with any "Present" finding during the slit lamp examination that, in the Investigator"s judgment, interferes with contact lens wear.
* Subjects with any scar or neovascularization within the central 4 mm of the cornea.
* Subjects who are allergic to any component in the study care products.

Primary outcomes:
measure: Percentage of Eyes With > Grade 2 Slit Lamp Findings
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Bausch & Lomb Incorporated
state: New York
Study officials:
affiliation: Bausch & Lomb Incorporated
name: Beverly Barna
role: STUDY_DIRECTOR
References:
Clinical trial NCT02185183: Oral Administration of AlequelTM for Patients With Inflammatory Bowel Disease (IBD)
Official title: Phase 2 Clinical Trial for Oral Administration of Alequel for Patients With IBD
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Crohn's Disease
Lead sponsor: Hadassah Medical Organization
Sponsor class: OTHER
First posted: 2014-07-09
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Oral administration of Alequel, a mixture of proteins derived from the patient's bowel will be tested in patients with inflammatory bowel disease.

Detailed description: Oral administration of Alequel prepared from patients biopsies will be tested in patients with inflammatory bowel disease to determine its anti inflammatory effect.

Eligibility criteria: Inclusion Criteria:

* Crohn's disease

Exclusion Criteria:

* Immune suppression

Primary outcomes:
measure: Number of Participants With Improved in Disease Activity
timeFrame: 15 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Hadassah Medical Organization
name: Yaron Ilan, M.D.
role: STUDY_DIRECTOR
References:
Clinical trial NCT01060683: Non-invasive Measurement of Hemoglobin Concentration With Pulse Co-oximetry
Official title: Liver Resection and Non-invasive Measurement of Hemoglobin Concentration With Pulse Co-oximetry
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Elective Hepatic Resection
Keywords: hemoglobin
Coagulation variables
blood chemistry
Blood gas analysis
Lead sponsor: University Medical Center Groningen
Sponsor class: OTHER
First posted: 2010-02-02
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: ASA class I and II patients for elective hepatic resection

Brief summary: The purpose of this study is to evaluate the accuracy of continuous SpHb measurement ( Rainbow DCI, Masimo, Irvine Ca, USA) compared to the current method of monitoring (blood sampling), both during phases of hemoconcentration and hemodilution.


Eligibility criteria: Inclusion Criteria:

* All patients: Age \> 18 years
* ASA class I and II patient requiring hepatic resection

Exclusion Criteria:

* Patient refusal
* Patients with a perioperative blood loss exceeding 5ml/kg

Primary outcomes:
measure: To evaluate the accuracy of continuous SpHb measurement during hepatic resection compared with standard (invasive) Hb measurement
timeFrame: during operation
Secondary outcomes:
measure: the effect of a bolus of crystalloid on SpHb level will be compared to the effect of a bolus of colloid on the SpHb level.
timeFrame: during operation
Other outcomes:
Locations:
city: Groningen
country: Netherlands
facility: University Medical Center Groningen,University of Groningen, the Netherlands
Study officials:
affiliation: University Medical Center Groningen
name: Herman G.D. Hendriks, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Vos JJ, Kalmar AF, Struys MM, Wietasch JK, Hendriks HG, Scheeren TW. Comparison of arterial pressure and plethysmographic waveform-based dynamic preload variables in assessing fluid responsiveness and dynamic arterial tone in patients undergoing major hepatic resection. Br J Anaesth. 2013 Jun;110(6):940-6. doi: 10.1093/bja/aes508. Epub 2013 Jan 24.
Clinical trial NCT02369783: Screening for Social Weaknesses and Coordination Course of Cancer Patients
Official title: Screening for Social Weaknesses and Coordination Course of Cancer Patients: A New Approach by an Expert System IT
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cancer
Lead sponsor: Institut de Cancérologie de la Loire
Sponsor class: OTHER
First posted: 2015-02-24
Enrollment: 71
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

Brief summary: The main objective of the study is to validate a methodology with Psychometric tool to measure levels of patients social fragility.

This tool will be dematerialized on a tablet. The answers will be then processed by a decision support algorithm, which automatically send an alert to detection of social fragility of the patient to the nurse navigators.


Eligibility criteria: Inclusion Criteria:

* All new patients enter ICLN for a diagnosis of cancer
* Patients who can read French or patients who can not read French, but accepting the translation by a close friend or family
* Patient having signed a free and informed consent

Exclusion Criteria:

* Refusal of participation, major patients protected under guardianship.
* Patient can not read French without possibility of translation by a close friend or family

Primary outcomes:
measure: Questionnaire validity
timeFrame: 1 hour
Secondary outcomes:
Other outcomes:
Locations:
city: St Priest en Jarez
country: France
facility: Institut de Cancerologie de la Loire
Study officials:
affiliation: INSTITUT DE CANCEROLOGIE DE LA LOIRE
name: Franck Chauvin, PhD-MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT01128283: Indicators of Inflammation and Coagulation in Sepsis
Official title: Temporal Behavior of Coagulation Factors, Cytokines and Tissue Injury Markers in Sepsis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sepsis
Keywords: Sepsis
organ failure
cytokines
clotting factors
Lead sponsor: University of Oklahoma
Sponsor class: OTHER
First posted: 2010-05-21
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: ICU patients

Brief summary: We will collect blood samples from patients with the diagnosis of sepsis and other ICU patients. We will describe the course of different mediator levels and organ injury markers and follow their progression throughout the course of the study.

Detailed description: After informed consent is obtained 5 cc of blood is collected on the day of admission and on days 0, 1, 3, and 7 thereafter. Plasma is collected and frozen for the subsequent measurement of biomarkers.

Eligibility criteria: Inclusion Criteria:

* Admission to the ICU

Exclusion Criteria:

* No blood draws scheduled
* Hemoglobin level \< 6,5 gm/dl

Primary outcomes:
measure: Death
timeFrame: 30 days
Secondary outcomes:
Other outcomes:
Locations:
city: Oklahoma City
country: United States
facility: OU Medical Center
state: Oklahoma
Study officials:
affiliation: University of Oklahoma
name: Gary T. Kinasewitz, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06215183: The Effect of Music on Pain, Anxiety and Satisfaction During Intrauterine Device Application
Official title: The Effect of Music on Pain, Anxiety and Satisfaction During Intrauterine Device Application
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Reproductive Health
Pain
Women Health
Keywords: Intrauterine device
Pain
Anxiety
Satisfaction
Lead sponsor: Saglik Bilimleri Universitesi
Sponsor class: OTHER
First posted: 2024-01-22
Enrollment: 70
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The study is a randomized controlled trial.
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study was planned to determine the effect of music listened to during intrauterine device application on pain,anxiety and satisfaction.

Detailed description: The randomized controlled and experimental study will be conducted with 70 women who apply to a Maternal and Child Health and Family Planning Center to have an Intrauterine Device (IUD). Women in the experimental group (n=35) will listen to music before, during and after the IUD application process, and the control group (n=35) will undergo routine IUD application. Information Form containing sociodemographic information, Situational Anxiety

Eligibility criteria: Inclusion Criteria:

* Knowing how to read and write,
* Not having had an IUD inserted before,
* Being between the ages of 18-49,
* No hearing-related problems,
* Not having used analgesic or anesthetic medication within 24 hours before or during the procedure,
* Voluntarily participating in the study,

Exclusion Criteria:

* The woman has a cognitive and auditory problem
* Having a history of cervical surgery

Primary outcomes:
measure: Anxiety
timeFrame: 30 minütes
measure: Pain Level
timeFrame: 30 minütes
Secondary outcomes:
measure: Satisfaction Level
timeFrame: 30 minütes
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Pendik District Health Directorate Maternal Child Health and Family Planning Center
state: Pendik
Study officials:
References:
Clinical trial NCT00534183: Metabolic Profile and Anthropometric Changes in Schizophrenia
Official title: Metabolic Profile and Anthropometric Changes in Schizophrenia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Metabolic Syndrome
Diabetes
Obesity
Keywords: Metabolic syndrome
Obesity
Diabetes
Lead sponsor: Central Institute of Psychiatry, Ranchi, India
Sponsor class: OTHER
First posted: 2007-09-24
Enrollment: 2006
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief summary: "No clinical differences will be found between the three antipsychotics under study - olanzapine, risperidone and haloperidol - on the patients' metabolic profile and weight. "

Detailed description: we aimed to study the effects of antipsychotics, olanzapine, risperidone and haloperidol on development of metabolic syndrome in a drug naïve population suffering from first episode schizophrenia and compared it with a matched healthy control group. We also aimed to examine the prevalence of metabolic syndrome as defined by the two most widely accepted definitions, the ATP IIIA and the IDF.

Eligibility criteria: Inclusion Criteria:

* Age between 18-40 years
* Diagnosis of schizophrenia
* Drug naive on admission

Exclusion Criteria:

* Other psychiatric co-morbidity
* History of severe physical illness
* Alcohol and substance abuse or dependence
* History of pre-existing diabetes or hypertension
* Family history of hypertension or diabetes

Primary outcomes:
measure: Study of metabolic profile
timeFrame: 6 weeks
Secondary outcomes:
measure: Study of obesity and diabetes
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Ranchi
country: India
facility: Central Institute of Psychiatry
Study officials:
affiliation: Central Institute of Psychiatry
name: Sahoo Saddichha, DPM
role: PRINCIPAL_INVESTIGATOR
References:
citation: Saddichha S, Manjunatha N, Ameen S, Akhtar S. Effect of olanzapine, risperidone, and haloperidol treatment on weight and body mass index in first-episode schizophrenia patients in India: a randomized, double-blind, controlled, prospective study. J Clin Psychiatry. 2007 Nov;68(11):1793-8. doi: 10.4088/jcp.v68n1120.