louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00851448: Safety, Tolerance and Efficacy of an Oral Nutritional Supplement in Lung Cancer Patients
Official title: Safety, Tolerance and Efficacy of an Oral Nutritional Supplement in Lung Cancer Patients. A Randomised, Double-blind, Controlled Pilot Study
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Cachexia
Cancer
Lead sponsor: Fresenius Kabi
Sponsor class: INDUSTRY
First posted: 2009-02-26
Enrollment: 17
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: To test the compliance, tolerance, safety and to get preliminary insights into the efficacy of a new oral nutritional supplement (containing n-3 fatty acids, amino acids and antioxidants) designed to prevent or delay cachexia and anorexia in lung cancer patients.


Eligibility criteria: Inclusion Criteria:

* non-small cell lung cancer patients stage IIIb or IV
* planned chemotherapy or combined chemo-/radiotherapy
* current body weight less than 6 months ago
* abnormal CRF level
* BMI \>=20 kg/m2 and \<=30kg/m2

Exclusion Criteria:

* significant oedema in the time of screening and randomisation
* concomitant inflammatory diseases
* active infections including HIV and AIDS
* liver failure
* chronic renal failure or cardiac pacemaker
* chronic heart failure
* insulin treated diabetes mellitus
* medications that impair sex hormone synthesis, secretion or function
* acute or chronic infections
* body weight loss \> 5% during the last 6 months or \> 10% during the last 10 months
* fish oil supplementation within 3 months prior to study entry
* taking vitamins in doses greater than recommended daily allowance
* life expectancy less than 6 months in the opinion of the investigator

Primary outcomes:
measure: compliance to nutrition therapy
timeFrame: baseline, months 1, 2, 3, 4
Secondary outcomes:
measure: anorexia questionnaire
timeFrame: baseline, months 1, 2, 3, 4
measure: gastrointestinal syndrome score (GIS)
timeFrame: baseline, months 1, 2, 3, 4
measure: body cell mass
timeFrame: baseline, months 1, 2, 3, 4
measure: weight change
timeFrame: baseline, months 1, 2, 3, 4
measure: hand grip strength
timeFrame: baseline, months 1, 2, 3, 4
measure: ECOG performance status
timeFrame: baseline, months 1, 2, 3, 4
Other outcomes:
Locations:
city: Rome
country: Italy
facility: Dipartimento di Medicina Clinica, La Sapienza Università, Rome
city: Ruda Slaska
country: Poland
facility: Indywidualna Specjalistyczna Praktyka lekarska
city: Warsaw
country: Poland
facility: Pulmonology Dept. of Miedzylesie Hospital
Study officials:
affiliation: La Sapienza Università, Rome
name: Filippo Rossi-Fanelli, Professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00152048: Evaluation of Eflornithine on Facial and Forearm Skin
Official title: A 24 Week Randomised Double Blind Placebo Controlled Study to Evaluate the Atrophogenic Potential of Eflornithine in the Treatment of Women With Excessive Facial Hair
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hirsutism
Lead sponsor: Allergan
Sponsor class: INDUSTRY
First posted: 2005-09-09
Enrollment: 78
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 85
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 evaluate whether regular use of eflornithine 11.5% cream in treating women with facial hair will induce skin damage (atrophy) on the face and/or forearms


Eligibility criteria: Inclusion Criteria:

* Female subjects with clinical diagnosis of facial hirsutism/excessive facial hair
* Women of childbearing potential must agree to use an effective form of birth control for the duration of the study
* Skin type I-IV
* Customary frequency of removal of facial hair two or more times per week

Exclusion Criteria:

* Pregnant or lactating women
* Severe inflammatory acne or presence of significant scarring on the face
* History of skin malignancy
* Connective tissue disorders

Primary outcomes:
measure: Change in facial skin thickness measured by ultrasound at 24 weeks
Secondary outcomes:
measure: Skin biopsies
measure: Histology and histochemistry in the dermis
measure: Physician Global Assessment
measure: Subject Self-Assessment Questionnaire
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03295448: Fatty Acid Biomarkers of Carbohydrate Intake
Official title: Circulating Fatty Acids as Biomarkers of Dietary Carbohydrates: a Randomized Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dyslipidemias
Keywords: fatty acids
biomarker
carbohydrate
lipogenesis
Lead sponsor: Uppsala University
Sponsor class: OTHER
First posted: 2017-09-27
Enrollment: 19
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The overall aim is to investigate if circulating fatty acids and lipids are influenced by alterations in carbohydrate amount and quality.

Detailed description: In this isocaloric clinical cross-over trial, the investigators aim to investigate if circulating fatty acids and lipids are influenced by alterations in carbohydrate amount and quality. The investigators intend to evaluate if changes in carbohydrate quantity and quality (including sugar) influence circulating even-chain saturated fatty acids or if fatty acid-derived indices of desaturation and de novo lipogenesis are more sensitive biomarkers of carbohydrate intake. By performing untargeted lipidomic analyses, the investigators aim to search for novel lipid biomarkers of carbohydrate quantity and quality. The investigators also want to evaluate the influence of moderate alterations of carbohydrate and sugar intake on lipoproteins, insulin sensitivity, inflammatory proteins.

Eligibility criteria: Inclusion Criteria:

* BMI 20-38

Exclusion Criteria:

* abnormal lab tests (assessed by screening and judged by a physician), diabetes, cardiovascular, kidney, liver or malignant disease, and weight-loss (±3kg) the preceding 3 months of screening. Extreme diets, i.e. very-low carbohydrate diets, intermittent fasting, vegan diets or allergic to gluten

Primary outcomes:
measure: Palmitic acid in different plasma fractions
timeFrame: 14-20 days
Secondary outcomes:
measure: Even-chain saturated fatty acids (i.e. 14:0, 18:0) and monounsaturated fatty acids
timeFrame: 14-20 days
Other outcomes:
measure: Desaturation indices end lipogenic indices
timeFrame: 14-20 days
Locations:
city: Uppsala
country: Sweden
facility: Uppsala univeristy hospital
Study officials:
affiliation: Uppsala University
name: Ulf Riserus, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05125848: Clinical Evaluation of the CM-1500 During Hemodialysis
Official title: Clinical Evaluation of the CM-1500 During Hemodialysis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fluid Loss
Dialysis
Lead sponsor: Zynex Monitoring Solutions
Sponsor class: INDUSTRY
First posted: 2021-11-18
Enrollment: 15
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: The study is a prospective, single-arm, non-randomized, non-blinded, non-controlled, non-significant risk, single center study enrolling up to 20 subjects consented to undergo a hemodialysis session as a part of their standard prescribed treatment plan. Subjects will consent to undergo non-invasive monitoring with the CM-1500 during three (3) separate sequential hemodialysis sessions.


Eligibility criteria: Inclusion Criteria:

* Ability to provide written informed consent
* Ability and willingness to comply with the study procedures and duration requirements, including connection of the device to the left wrist/hand and maintaining relatively motionless during the session
* 18 years of age or older
* Planned to undergo a minimum of three (3) hemodialysis sessions within the two (2) weeks following enrollment.

Exclusion Criteria:

* Females who are pregnant or breastfeeding
* Undergone an amputation of the left upper extremity
* Subjects with left arm hemodialysis access only
* Diagnosed with dextrocardia
* Subjects who have a pacemaker
* Subjects who have any other underlying condition that would inhibit completion of participation in the study, per Investigator opinion

Primary outcomes:
measure: Average Relative Index Value Following a Hemodialysis Procedure
timeFrame: Duration of post-hemodialysis recovery period (10-minutes)
Secondary outcomes:
measure: Mean Intrasubject Variability (Standard Deviation) in Relative Index (RI) During Hemodialysis Sessions
timeFrame: Duration of standard dialysis procedure (Range: 131 to 241 minutes)
measure: Mean Intersubject Variability (Standard Deviation) in Relative Index (RI) During Hemodialysis Sessions
timeFrame: Duration of standard dialysis procedure (Range: 131 to 241 minutes)
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: DaVita Clinical Research
state: Minnesota
Study officials:
affiliation: InterMed Consultants
name: Jonathan Tolins, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02770248: 24-hr Intraocular Pressure Control With SIMBRINZA ®
Official title: 24-hr Intraocular Pressure Control With Brinzolamide 1% / Brimonidine 0.2% Ophthalmic Suspension vs Vehicle
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Glaucoma
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2016-05-12
Enrollment: 162
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate differences between treatments in mean change from baseline in 24-hr intraocular pressure (IOP) at Week 4.

Detailed description: Subjects will undergo washout of pre-study IOP-lowering medications for the appropriate duration, then undergo 2 eligibility visits. Eligible subjects will be randomized 1:1, to receive masked SIMBRINZA ® or Vehicle for 4 weeks. Two 24-hour visits will be conducted (Day 0 and Week 4) during which intraocular pressure will be collected every 2 hours. The expected duration of subject participation in the study is 10 weeks.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of either open-angle glaucoma or ocular hypertension;
* Able to attend all study related visits and be housed overnight at clinical site for the study assessments;
* Willing and able to sign an informed consent form;
* Other protocol-specified inclusion criteria may apply.

Exclusion Criteria:

* Women of childbearing potential who are pregnant, intend to become pregnant during the study, breast-feeding, or not using adequate birth control;
* Diagnosed with any form of glaucoma other than open angle glaucoma or ocular hypertension;
* Ocular surgeries or procedures excluded by the protocol;
* Diseases, illnesses, infections, or ocular abnormalities excluded by the protocol;
* Best-corrected visual acuity score less than 55 ETDRS letters (equivalent to approximately 20/80 Snellen) in either eye;
* Other protocol-specific exclusion criteria may apply.

Primary outcomes:
measure: Least Squares Mean Change From Baseline in 24-hr Intraocular Pressure (IOP) at Week 4
timeFrame: Baseline (Day 0), Week 4
Secondary outcomes:
measure: Least Squares Mean Change From Baseline in Daytime IOP at Week 4
timeFrame: Baseline (Day 0), Week 4
measure: Least Squares Mean Change From Baseline in Nocturnal IOP at Week 4
timeFrame: Baseline (Day 0), Week 4
measure: Least Squares Mean Change From Baseline in IOP for Each Time Point (8 AM Through 6 AM) at Week 4
timeFrame: Baseline (Day 0), Week 4
Other outcomes:
Locations:
Study officials:
affiliation: Alcon Research
name: Clinical Manager, GCRA
role: STUDY_DIRECTOR
References:
Clinical trial NCT01371448: Special Drug Use Investigation for PAXIL Tablet (Long-term)
Official title: Special Drug Use Investigation for PAXIL Tablet (Long-term)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Mental Disorders
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2011-06-10
Enrollment: 339
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with depression/depressed state or panic disorder which are the indications of PAXIL for long-term use

Brief summary: This surveillance study is designed to detect adverse events (particularly clinically significant adverse drug reactions) occurring in clinical settings and to examine factors likely to affect the safety and efficacy of paroxetine in long-term use (1 year).


Eligibility criteria: Inclusion Criteria:

* Patients with depression/depressed state or panic disorder
* PAXIL must be used for long-term

Exclusion Criteria:

* Patients who had been taking PAXIL since before the start of the survey
* Patients with hypersensitivity to paroxetine
* Patients taking monoamine oxidase inhibitors (MAOIs) or within 2 weeks of stopping treatment with MAOIs
* Concomitant use in patients taking pimozide

Primary outcomes:
measure: Incidence of adverse events in Japanese subjects treated with paroxetine tablet based on prescribing information under the conditions of general clinical practice
timeFrame: 1 year
measure: Presence/absence of concomitant use of drugs metabolized by CYP2D6
timeFrame: Within 2 weeks after discontinuation or completion of treatment
measure: Presence/absence of concomitant use of products containing Saint John's Wort (Hypericum perforatum; "SJW", hereinafter)
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT03976648: A Clinical Study to Test Long Term Safety of GLPG1690 for Patients With Systemic Sclerosis
Official title: A Multicenter, Open-label Extension Study to Evaluate the Long-term Safety, Tolerability and Efficacy of Orally Administered GLPG1690 in Subjects With Systemic Sclerosis
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Systemic Sclerosis
Lead sponsor: Galapagos NV
Sponsor class: INDUSTRY
First posted: 2019-06-06
Enrollment: 31
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study was the extension of the double-blind study GLPG1690-CL-204 (NCT03798366). The main purpose of the study was to see how GLPG1690 was tolerated in participants with systemic sclerosis and whether there were any side effects in a long-term treatment period.


Eligibility criteria: Inclusion Criteria:

* Male or female participants who completed the 24-week treatment period of Study GLPG1690-CL-204 and who according to the investigator's judgment may benefit from long-term treatment with GLPG1690.

Exclusion Criteria:

* Any condition or circumstances that, in the opinion of the investigator, may make a participant unlikely or unable to complete the study or comply with study procedures and requirements.

Primary outcomes:
measure: Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious TEAEs
timeFrame: Day 1 up to 91 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Pacific Arthritis Care Center
state: California
city: Los Angeles
country: United States
facility: UCLA Rheumatology
state: California
city: Boca Raton
country: United States
facility: RASF Clinical Research Center
state: Florida
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
city: Dallas
country: United States
facility: Metroplex Clinical Research Center
state: Texas
city: Houston
country: United States
facility: UT Physicians Center for Autoimmunity
state: Texas
city: Gent
country: Belgium
facility: UZ Gent
city: Leuven
country: Belgium
facility: UZ Leuven
city: Firenze
country: Italy
facility: Azienda Ospedaliero Universitaria Careggi
city: Milano
country: Italy
facility: Ospedale San Raffaele S.r.l. - PPDS
city: Barcelona
country: Spain
facility: Hospital Universitario Vall d'Hebron
city: Madrid
country: Spain
facility: Hospital Universitario 12 de Octubre
city: Liverpool
country: United Kingdom
facility: University Hospital Aintree
city: London
country: United Kingdom
facility: Royal Free Hospital
Study officials:
affiliation: Galapagos NV
name: Galapagos Study Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT06284148: Confidential IPV Screening Tool
Official title: EHR-based Screening and Intervention for Intimate Partner Violence
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Violence, Domestic
Keywords: Intimate Partner Violence
Lead sponsor: Medical University of South Carolina
Sponsor class: OTHER
Collaborators: name: Agency for Healthcare Research and Quality (AHRQ)
First posted: 2024-02-28
Enrollment: 19655
Sex: ALL
Minimum age (years): 18
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: This is a stepped wedge cluster randomized trial which has 3 sequences starting intervention in randomized order.
Primary purpose: SCREENING

Brief summary: Intimate partner violence (IPV) against women in the US is a serious public health problem and a human rights issue. Our research team has developed confidential screening tools using exam-room computer for intimate partner violence to be used in primary care.

Detailed description: The objective of this study was to develop and evaluate an integrated suite of electronic health record (EHR) tools that automates "best practices" from Northern California Kaiser Permanente for screening and intervention for IPV identified within clinical settings. The goal of the intervention goes beyond mere screening of patients for IPV and includes tools for assessment of IPV risk, for documentation of IPV care, and support for a warm hand-off during the primary care visit to a national IPV hotline resource. Importantly, the study includes work to keep notes documenting IPV and billing for IPV care confidential, segmenting this care in a secure segment of the electronic health record.

Eligibility criteria: Inclusion Criteria:

* Being an Medical University of South Carolina patient at primary care clinics (family medicine)
* Women 18-49 years of age inclusive
* Reported yes to wanting to be contacted for a follow-up research study
* English-speaking

Exclusion Criteria:

* No exclusion criteria

Primary outcomes:
measure: IPV positive (Yes/No)
timeFrame: 29 months
measure: Screening completed (Yes/No)
timeFrame: 29 months
Secondary outcomes:
measure: Severity of risk
timeFrame: 29 months
measure: Physician compliance with IPV management tools
timeFrame: 29 months
Other outcomes:
Locations:
city: Charleston
country: United States
facility: Biomedical Informatics Center
state: South Carolina
Study officials:
References:
Clinical trial NCT06207448: Deep Infiltrating Endometriosis : Laparoscopic Nerve-sparing Surgery and Use of Neutral Argon Plasma
Official title: Deep Infiltrating Endometriosis : Laparoscopic Nerve-sparing Surgery and Use of Neutral Argon Plasma
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Endometriosis Ovary
Keywords: Endometriosis Ovary
Laparoscopic Surgery
Laparoscopic Surgical Procedure
Schwanoma
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2024-01-17
Enrollment: 1
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult woman (≥18 years old) who benefited from treatment by nerve-sparing surgery and the use of neutral argon plasma in the context of symptomatic deep pelvic endometriosis at the Strasbourg University Hospital during 2021

Brief summary: Medical treatment of endometriosis has a suspensive and sometimes incomplete effect on the symptoms, making surgical treatment necessary. The aim of surgical treatment of deep endometriosis is to restore normal anatomy and functional integrity. Resection of deep endometriosis lesions is recommended to relieve pain, gynecological and digestive symptoms, but rarely urinary disorders. Nerve-sparing surgery, when feasible, reduces post-operative dysuria by sparing the lower hypogastric plexus.

The major limitations of these surgical procedures are the experience of the surgeon and the extent of the disease. Acquiring the surgical techniques and skills necessary to carry out these types of procedures is essential to providing optimal patient care.


Eligibility criteria: Inclusion Criteria:

* Adult woman (≥18 years old)
* Patient who benefited from treatment by nerve-sparing surgery and the use of neutral argon plasma in the context of symptomatic deep pelvic endometriosis at the Strasbourg University Hospital during 2021
* Patient who did not express, after information, the reuse of her data for the purposes of this research.

Exclusion Criteria:

* Patient who expressed her opposition to participating in the study
* Patient under legal protection, under guardianship or under curatorship

Primary outcomes:
measure: To retrospectively describe the minimally invasive management of deep pelvic endometriosis using nerve-sparing surgery and the use of neutral argon plasma for extensive endometriotic lesions by laparoscopy
timeFrame: up to 2 months
Secondary outcomes:
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Service de Gynécologie Obstétrique - CHU de Strasbourg - France
Study officials:
References: