louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00737867: Vinorelbine/Gemcitabine Versus Vinorelbine/Carboplatin in Advanced Non-small Cell Lung Cancer
Official title: Vinorelbine Plus Gemcitabine (VG) Versus Vinorelbine Plus Carboplatin (VC) in Advanced Non-small Cell Lung Cancer. An Open Randomized Multicenter Phase III Trial From Norwegian Lung Cancer Study Group (NLCG)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Advanced Non-Small Cell Lung Cancer
Keywords: lung cancer
chemotherapy
vinorelbine
gemcitabine
carboplatin
advanced lung cancer
non-small cell lung cancer
Lead sponsor: The Norwegian Lung Cancer Study Group
Sponsor class: NETWORK
First posted: 2008-08-20
Enrollment: 444
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 explore if the combination of vinorelbine and gemcitabine is better than vinorelbine and carboplatin in the treatment of advanced non-small cell lung cancer, in terms of survival, quality of life and need for palliative radiotherapy.


Eligibility criteria: Inclusion Criteria:

* Non-small cell lung cancer stage IIIB or IV
* Not eligible for radical radiotherapy or surgery
* WHO performance status 0-2

Exclusion Criteria:

* Pregnancy
* Other clinical active cancer disease
* ALAT/ALP more than 3 times upper normal limit, bilirubin \>1.5 upper limit
* Bowel disease that causes malabsorption

Primary outcomes:
measure: survival
timeFrame: one year
Secondary outcomes:
measure: Health related quality of life (HrQoL)
timeFrame: 3 months
measure: Toxicity
timeFrame: 3 months
measure: Need for palliative radiotherapy
timeFrame: one year
Other outcomes:
Locations:
city: Bergen
country: Norway
facility: Øystein Fløtten
city: Haugesund
country: Norway
facility: Sverre Fluge
city: Kristiansand
country: Norway
facility: Heidi Rolke
city: Trondheim
country: Norway
facility: Tore Amundsen
Study officials:
affiliation: Haukeland University Hospital, thoracic department
name: Øystein Fløtten
role: STUDY_CHAIR
References:
Clinical trial NCT00758667: Chemically Assisted Capsulectomy-A New Clinical Approach
Official title: Chemically Assisted Capsulectomy-A New Clinical Approach
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Implant Capsular Contracture
Keywords: capsular contracture
capsulectomy
mesna
Capsular contracture after breast implant placement
Lead sponsor: Vanderbilt University
Sponsor class: OTHER
First posted: 2008-09-25
Enrollment: 20
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to make available an agent,Mesna, which can assist the surgeon during the procedure of capsulectomy.

Detailed description: Mesna is a FDA approved drug for the treatment of respiratory diseases and is used a protective agent against drugs in oncology patients. It has also been used in Gynecologic surgery and ENT. Mesna is a drug that breaks down adhesions between tissue layers.

Eligibility criteria: Inclusion Criteria:

* All females undergoing capsulectomy

Exclusion Criteria:

* All pregnant women and nursing mothers will be exclued

Primary outcomes:
measure: Compare Number of Patients With Capsular Contracture in Mesna Group vs Standard of Care
timeFrame: one year
Secondary outcomes:
measure: Compare Number of Patients With Adverse Events in the Mesna Group vs the Standard of Care
timeFrame: one year
Other outcomes:
Locations:
Study officials:
affiliation: Vanderbit Unviersity Medical Center
name: Bruce Shack, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01001767: Pilot Placebo Controlled Study With Lovaza in Cardiovascular Disease
Official title: Prospective Randomized Placebo Controlled Trial of Omega-3 Fatty Acids in HIV Infected Subjects to Modulate Cardiovascular Risk
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: HIV Infections
Heart Disease
Keywords: Omega-3 Fatty Acids
HIV
Heart Disease
Treatment experienced
Lead sponsor: University Hospitals Cleveland Medical Center
Sponsor class: OTHER
Collaborators: name: The Campbell Foundation
name: Case Western Reserve University
name: GlaxoSmithKline
First posted: 2009-10-27
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: Several studies have shown that there is an increased risk of heart disease in people with HIV. In this study the investigators are looking at the effect of Lovaza (Omega-3 fatty acid) on improving endothelial function and decreasing inflammation which may contribute to this increased risk. The investigators will also be doing studies to analyze coagulation and inflammation markers.


Eligibility criteria: Inclusion Criteria:

* HIV+
* Ages 18-70
* HIV-1 RNA \<400 copies/ml.
* On stable ART (antiretroviral therapy) regimen for 12 weeks with no intent of modifying regimen, and cumulative ART before study entry of 12 mos.

Exclusion Criteria:

* Active infection
* Inflammation or malignancy
* Uncontrolled diabetes or hypothyroidism
* LDL (low density lipoprotein) cholesterol \>160 and triglyceride levels \>750
* Framingham risk score \<6.

Primary outcomes:
measure: Change in Flow Mediated Dilation (FMD) of the Brachial Artery
timeFrame: baseline and week 24
Secondary outcomes:
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: University Hospitals of Cleveland Case Medical Center
state: Ohio
Study officials:
affiliation: University Hospitals Cleveland Medical Center
name: Grace McComsey, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hileman CO, Carman TL, Storer NJ, Labbato DE, White CA, McComsey GA. Omega-3 fatty acids do not improve endothelial function in virologically suppressed HIV-infected men: a randomized placebo-controlled trial. AIDS Res Hum Retroviruses. 2012 Jul;28(7):649-55. doi: 10.1089/aid.2011.0088. Epub 2011 Oct 17.
Clinical trial NCT04406467: Retrospective Review of Xen Gel Stent Implantation With Open vs. Closed Conjunctiva Approach
Official title: Retrospective Review of Xen Gel Stent Implantation With Open vs. Closed Conjunctiva Approach
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Glaucoma, Open-Angle
Keywords: Glaucoma surgery
Xen Gel Stent
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: New York University
First posted: 2020-05-28
Enrollment: 137
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients presenting to the two institutions with elevated IOP and required surgery to lower IOP.

Brief summary: To measure surgical success of open vs closed conjunctiva with Xen implantation.

Detailed description: This retrospective, single-arm multicenter study included \>100 eyes (\>100 patients) with glaucoma refractory to medical therapy. All surgeries were performed by two groups of surgeons at Johns Hopkins University and the sub-investigator group at New York University. Group 1: Xen with open conjunctiva for positioning and application of mitomycin. The Xen was placed through the sclera either ab-interno or ab-externa. Group 2 had Xen placed ab-interno or ab-externa (trans conjunctival), but the conjunctiva was not opened for positioning or application of mitomycin-C.

Success rates will be determined based on need for re-intervention and intraocular pressure control.

Eligibility criteria: Inclusion Criteria:

* Require surgery for uncontrolled glaucoma

Exclusion Criteria:

* None

Primary outcomes:
measure: re-intervention rate
timeFrame: 3 months
Secondary outcomes:
measure: Change in intraocular pressure
timeFrame: 1 day, 1 week, 1 month and 3 months
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins Univeristy
state: Maryland
Study officials:
References:
citation: Panarelli JF, Yan DB, Francis B, Craven ER. XEN Gel Stent Open Conjunctiva Technique: A Practical Approach Paper. Adv Ther. 2020 May;37(5):2538-2549. doi: 10.1007/s12325-020-01278-1. Epub 2020 Mar 21.
citation: Do A, McGlumphy E, Shukla A, Dangda S, Schuman JS, Boland MV, Yohannan J, Panarelli JF, Craven ER. Comparison of Clinical Outcomes with Open Versus Closed Conjunctiva Implantation of the XEN45 Gel Stent. Ophthalmol Glaucoma. 2021 Jul-Aug;4(4):343-349. doi: 10.1016/j.ogla.2020.12.003. Epub 2020 Dec 13.
Clinical trial NCT05438940: Support Through Remote Observation and Nutrition Guidance (STRONG) Program for Gastroesophageal Cancer (GEC) Patients
Official title: Support Through Remote Observation and Nutrition Guidance (STRONG) Program for Gastroesophageal Cancer (GEC) Patients
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: GastroEsophageal Cancer
Keywords: Nutrition Support
Lead sponsor: H. Lee Moffitt Cancer Center and Research Institute
Sponsor class: OTHER
First posted: 2022-06-30
Enrollment: 23
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of the study is to assess the feasibility and patient satisfaction with the Support through Remote Observation and Nutrition Guidance (STRONG) program. The program provides nutrition support for participants living with gastroesophageal cancer who are receiving chemotherapy and radiation treatment


Eligibility criteria: Inclusion Criteria:

* ≥18 years old
* Locally advanced or metastatic GEC diagnosis
* Planned to initiate chemoradiation and/or radiation therapy with a plan to have surgery or a plan to have definitive treatment at Moffitt.
* Able to speak and read English
* Able to provide informed consent

Exclusion Criteria:

* Documented or observable psychiatric or neurological disorder that would interfere with study participation (e.g., psychosis, active substance abuse)
* Undergoing concurrent treatment for a secondary primary cancer
* Use of feeding tubes before enrollment (The last exclusion criterion was included because investigators do not anticipate these participants would benefit from a dietary monitoring intervention)

Primary outcomes:
measure: Recruitment Rate - Feasibility
timeFrame: 12 Months
measure: Retention Rate - Feasibility
timeFrame: 12 Months
measure: Data Collection - Feasibility
timeFrame: 12 Months
measure: Participant Satisfaction - Acceptability
timeFrame: 12 Months
measure: Participant Rating on Ease of Use the Mobile Application - Usability
timeFrame: 12 Months
Secondary outcomes:
measure: Participant Compliance with Dietician Visit - Intervention adherence
timeFrame: 12 Months
measure: Participant Compliance with Dietary Log - Intervention adherence
timeFrame: 12 Months
Other outcomes:
Locations:
city: Tampa
country: United States
facility: Moffitt Cancer Center
state: Florida
Study officials:
affiliation: Moffitt Cancer Center
name: Kea Turner, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Moffitt Cancer Center
name: Jose M Pimiento, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02832440: Comparison of Two Exercise Programmes in Patients Undergoing Hemodialysis
Official title: Comparison of Intradialytic Versus Home-based Programmes on Adherence and Strength of Stage 5 Chronic Kidney Disease Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: End Stage Renal Disease
Lead sponsor: Cardenal Herrera University
Sponsor class: OTHER
First posted: 2016-07-14
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Although exercise training of haemodialysis patients is associated with generally positive outcomes few haemodialysis units routinely offer intradialytic exercise therapy. This is often related to financial cost and/or staffing limitations. Home-based programs could be an alternative means of providing exercise benefits without associated implementation costs The aim of this study was to compare the effects of 4 weeks intradialytic versus home based exercise for haemodialysis patients regarding adherence and strength gains.


Eligibility criteria: Inclusion Criteria:

* people under hemodialysis treatment at least 3 months
* be medicable stable
* complete all the physical tests

Exclusion Criteria:

* heart stroke in the previous 6 weeks of the study
* inferior limb amputation without artificial aids
* cerebral vascular disease (ictus, ischemic)
* disability to complete functional tests

Primary outcomes:
measure: Change from Baseline Short Physical Performance Battery at 4 months
timeFrame: At the beginning and after 4 months
measure: Change from Baseline One leg standing test at 4 months
timeFrame: At the beginning and after 4 months
measure: Change from Baseline Timed Up and Go test at 4 months
timeFrame: At the beginning and after 4 months
measure: Change from Baseline Sit to stand to sit 10 and 60 at 4 months
timeFrame: At the beginning and after 4 months
measure: Change from Baseline One leg heel rise at 4 months
timeFrame: At the beginning and after 4 months
measure: Change from Baseline Handgrip Strength at 4 months
timeFrame: At the beginning and after 4 months
measure: Change from Baseline Six minutes walking test at 4 months
timeFrame: At the beginning and after 4 months
Secondary outcomes:
Other outcomes:
Locations:
city: Moncada
country: Spain
facility: Universidad CEU Cardenal Herrera
state: Valencia
Study officials:
affiliation: Lecturer in the Cardenal Herrera University
name: Eva Segura Ortí
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00497640: CPAP Titration Using an Artificial Neural Network: A Randomized Controlled Study
Official title: CPAP Titration Using an Artificial Neural Network: A Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Obstructive Sleep Apnea
Keywords: sleep apnea, titration, CPAP, neural network
Lead sponsor: State University of New York at Buffalo
Sponsor class: OTHER
First posted: 2007-07-06
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of the study is to determine the validity of the prediction model in reducing the rate of CPAP titration failure and in achieving a shorter time to optimal pressure

Detailed description: In order to derive the most effective pressure, CPAP titration is performed in the sleep laboratory during which the pressure is gradually increased until apneas and hypopneas are abolished in all sleep stages and in all body positions. The technique is however time consuming and labor intensive. Furthermore, the duration of the study may not be sufficient to attain this goal because of patient's poor ability to sleep in this environment or due to difficulty in attaining an appropriate pressure. A predictive algorithm based on demographic, anthropometric, and polysomnographic data was developed to facilitate the selection of a starting pressure during the overnight titration study. Yet, the performance of this model was inconsistent when validated by other centers. One of the potential reasons for the lack of reproducibility is the complex relation of behavioral processes with nonlinear attributes. In areas of complex interactions, the artificial neural network (ANN) has been found to be a more appropriate alternative to linear, parametric statistical tools due to its inherent property of seeking information embedded in relations among variables thought to be independent.

Comparison: time to achieve optimal pressure in the conventional technique versus the intervention model

Eligibility criteria: Inclusion Criteria:

1. patients 18 years of age and older,
2. documented OSA by sleep study defined as AHI \> 5/hr

Exclusion Criteria:

1. previously treated OSA,
2. unwilling to undergo a titration study,
3. unable or unwilling to sign an informed consent.

Primary outcomes:
measure: Time to achieve optimal CPAP
timeFrame: minutes
Secondary outcomes:
measure: Failure Rate of CPAP titration
timeFrame: percentage
Other outcomes:
Locations:
city: Buffalo
country: United States
facility: State University of New York at Buffalo
state: New York
Study officials:
affiliation: Sate University of New York at Buffalo
name: Ali A El Solh, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: El Solh AA, Aldik Z, Alnabhan M, Grant B. Predicting effective continuous positive airway pressure in sleep apnea using an artificial neural network. Sleep Med. 2007 Aug;8(5):471-7. doi: 10.1016/j.sleep.2006.09.005. Epub 2007 May 18.
Clinical trial NCT03108040: Evaluation of Fetal Cardiac Function and Vascular Hemodynamics in Intrauterine Growth Restriction
Official title: Evaluation of Non Invasive Fetal Cardiac Functions and Fetal Arterial&Venous Doppler Study in Intrauterine Growth Restriction as Predictive Parameters of Perinatal Outcome
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Fetal Hypoxia
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2017-04-11
Enrollment: 534
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: observational study conducted at academic perinatalcenter that investigates relationships between antenatal testing parameters and outcome in IUGR fetuses Patients who give written consent to participate in the study undergo a uniform antenatal assessment protocol that includes umbilical artery (UA), middle cerebral artery (MCA) and ductus venosus (DV) Doppler ultrasound studies as well as detailed fetal echocardiography and five-component biophysical profile score.

- Criteria for study eligibility are:

* Singleton fetus with normal fetal anatomy documentedon a detailed sonogram.
* Fetal abdominal circumference \<5th percentile forgestational age.•
* Evidence of placental insufficiency documented by an elevated umbilical artery pulsatility index (UA-PI) by reference ranges.

Brief summary: Intrauterine growth restriction (IUGR) is one of the major contributors to perinatal mortality and morbidity and is characterized by complex hemodynamic changes involving placental and fetal arterial, cardiac and venous circulations .However, the temporal sequence of these modifications in relation to other hemodynamic changes of the fetal arterial and venous circulations is unknown.

The aim of this study was to evaluate cardiac function and other hemodynamic changes in a group of fetuses with IUGR and clinical impact on perinatal outcome .


Eligibility criteria: Inclusion Criteria:

* Singleton fetus with normal fetal anatomy documented a detailed sonogram.
* Fetal abdominal circumference \<5th percentile for gestational age.
* Evidence of placental insufficiency documented by an elevated umbilical artery pulsatility index (UA-PI) by reference ranges.

Exclusion Criteria:

* evidence of fetal infection
* chorioamnionitis
* fetal anomalies
* abnormal fetal karyotype
* patient withdrawal from the study and/or unavailability for follow-up.

Primary outcomes:
measure: Myocardial performance index
timeFrame: 5 minutes
measure: Aortic isthmus flow index
timeFrame: 5 minutes
measure: Cerebroplacental ratio
timeFrame: 5 minutes
measure: Preload Index in inferior vena cava
timeFrame: 5 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Advanced Fetal Cair Unit - Assiut University
Study officials:
References:
Clinical trial NCT04591340: Effect of Standardized Nutrient Management on Clinical Outcomes of Hematopoientic Stem Cell Transportation Patients
Official title: Effect of Standardized Nutrient Management on Clinical Outcomes of Hematopoientic Stem Cell Transportation Patients--a Cross-sectional Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Nutrition Related Cancer
Keywords: HSCT; Nutrtion
Lead sponsor: The Third Xiangya Hospital of Central South University
Sponsor class: OTHER
First posted: 2020-10-19
Enrollment: 100
Sex: ALL
Minimum age (years): 10
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Both female and male patients and between 10 to 79 years old treated with HSCT can be included.

Brief summary: To analysis a standardized stepped nutritional treatment process for patients with hematopoietic stem cell transportation, including nutritional risk screening and assessment, standardized nutritional treatment implementation, therapeutic effect follow-up and monitoring, family nutritional treatment follow-up, etc

Detailed description: Standardized nutrition therapy for patients with hematopoietic stem cell transportation should follow the principle of sequential treatment of nutrition, which is the preferred scheme with individualized dietary advice or oral nutritional supplement, if their energy intake will not reach 60% of the goal level during the transplanting, then supplementary parenteral nutrition or total parenteral nutrition is needed. The standardized nutrition therapy aims to improve quality of life and long-term survival rate of patients, reduce the complications and social burden of disease.

Eligibility criteria: Inclusion Criteria:

* • Patients treated with HSCT

Exclusion Criteria:

* nothing

Primary outcomes:
measure: Improvement of nutritional status
timeFrame: 4 months
measure: Improvement of quality of life
timeFrame: 4 months
Secondary outcomes:
Other outcomes:
Locations:
city: Changsha
country: China
facility: Feng
state: Hunan
Study officials:
References: