louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05074589: Irinotecan Liposome in Combination With 5-FU/LV Versus 5-FU/LV in Second-line Therapy for Gemcitabine-Refractory Pancreatic Cancer
Official title: A Randomized, Double-blind, Single-dummy, Parallel-controlled, Multicentre, Phase III Clinical Study of Irinotecan Hydrochloride Liposome in Combination With 5-FU/LV as Second-line Treatment for Locally Advanced or Metastatic Pancreatic Cancer After Treatment Failure With Gemcitabine-based Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Second-line Treatment for Locally Advanced or Metastatic Pancreatic Cancer After Treatment Failure With Gemcitabine-based Therapy
Lead sponsor: Jiangsu HengRui Medicine Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2021-10-12
Enrollment: 298
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A randomized, double-blind, single-dummy, parallel-controlled, multicentre study
Primary purpose: TREATMENT

Brief summary: To evaluate efficacy and safety of irinotecan hydrochloride liposome in combination with 5-FU/LV as second-line treatment for locally advanced or metastatic pancreatic cancer after treatment failure with gemcitabine-based therapy.


Eligibility criteria: Inclusion Criteria:

1. Histologically or cytologically confirmed pancreatic cancer;
2. Unresectable locally advanced or metastatic disease ;
3. Documented disease progression after first-line treatment gemcitabine based therapy
4. ECOG: 0-1;
5. Adequate organ and bone marrow function;
6. sign an informed consent.

Exclusion Criteria:

1. Active CNS metastasis;
2. Uncontrolled tumor-related pain;
3. Clinically significant GI disorders;
4. Significant cardiovascular disease;
5. Active infection or uncontrolled fever;
6. Pregnant or breast feeding patients;
7. Allergic to a drug ingredient or component;
8. The investigators determined that other conditions were inappropriate for participation in this clinical trial.

Primary outcomes:
measure: Overall Survival(OS)
timeFrame: The maximum time in follow up was approximately 12 months
Secondary outcomes:
measure: Progression Free Survival
timeFrame: The maximum time in follow up was 12 months
measure: Objective Response Rate
timeFrame: Assessment every 6 weeks after initial response; maximum time on study 12 months
measure: Time to Treatment Failure
timeFrame: The maximum time in follow up was 12 months
measure: Percentage of Patients With Tumor Marker (CA 19-9) Response
timeFrame: Baseline to treatment discontinuation every 6 weeks; The maximum time in follow up was 12 months
measure: Quality of life（QoL）
timeFrame: Baseline to treatment discontinuation every 6 weeks; The maximum time in follow up was 12 months
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Qinhuai Medical Area, General Hospital of PLA Eastern Theater Command
state: Jiangsu
Study officials:
References:
Clinical trial NCT06119789: Precision Cancer Therapy in Rare Cancers
Official title: The MATRIX Clinical Studies of Precision Cancer Therapy for Rare Cancers
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Rare Malignant Neoplasm
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
Collaborators: name: Helse Stavanger HF
name: University Hospital of North Norway
name: StOlavs Hospital
name: Nordlandssykehuset HF
name: Helse Nord-Trøndelag HF
name: Sorlandet Hospital HF
name: Møre og Romsdal Hospital Trust
name: The Hospital of Vestfold
name: Helse Fonna
name: Haukeland University Hospital
name: Sykehuset Ostfold
name: Helse Forde
name: Sykehuset Innlandet HF
First posted: 2023-11-07
Enrollment: 96
Sex: ALL
Minimum age (years): 16
Maximum age (years): 99
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: simon two stage model
Primary purpose: TREATMENT

Brief summary: Some rare cancers are hard-to-treat and patients have a poor prognosis. It is known that some of these patients have targetable molecular alterations, and some benefit from targeted drugs. However in many cases these drugs are not approved for the rare cancers.

In this study the aim is to do advanced molecular diagnostics to identify possible targets for therapy, and to treat accordingly.

Detailed description: All patients will have the tumour cells diagnosed with a large genepanel, analyzing more than 500 genes on DNA / RNA level. Patients will be treated based on the molecular characteristics of the tumor cells.

Eligibility criteria: Inclusion Criteria:

* ECOG 0-2,
* identified biomarker,
* reasonable biochemistry

Exclusion Criteria:

* ECOG 3-5
* serious other diseases

Primary outcomes:
measure: Radiological response evaluation at 16 weeks of treatment
timeFrame: 16 weeks
Secondary outcomes:
measure: Molecular analyses predicting responses
timeFrame: 2 years
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Oslo University Hospital
Study officials:
affiliation: Oslo University Hospital
name: Sigbjørn Smeland, MD PhD
role: STUDY_CHAIR
References:
Clinical trial NCT01949389: Piloting an Internet-based Therapy for Insomnia in a Population of Veterans With Substance Use Disorders
Official title: Piloting an Internet-based Therapy for Insomnia in a Population of Veterans With Substance Use Disorders
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Insomnia
Lead sponsor: VA Connecticut Healthcare System
Sponsor class: FED
First posted: 2013-09-24
Enrollment: 51
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purposes of this study is to examine the feasibility of implementing an internet-based treatment for insomnia among veterans with substance use disorders, some with co-morbid serious mental illness, and to develop potential methods to support and encourage veterans while they self-administer this treatment. Our hypotheses are that the implementation of an internet-based therapy will be feasible and that a method of support can be devised, and tested in the future.


Eligibility criteria: Inclusion Criteria:

* Inability to sleep within 30 minutes of going to bed or awakening during the night for 30 minutes for greater than or equal to 3 days per week
* Above Criteria occurring every week for greater than or equal to 3 months
* At least one symptom of daytime impairment: (reduced motivation, sleepiness, fatigue, lack of concentration, performance at home, work, social life, relationships impaired)
* Able to provide valid consent
* Willing to participate in an internet-based cognitive behavioral therapy for insomnia
* English speaking

Exclusion Criteria:

* Self-reported or provider diagnosed sleep apnea or related nighttime respiratory problem, restless legs syndrome or related nighttime movement disorder
* Acute psychiatric decompensation requiring inpatient admission or emergency department services within the last month (suicidality, homicidally, mania, psychotic decompensation)
* Current treatment or treatment within the last month for opiate addiction with methadone maintenance or buprenorphine.
* Has a conservator E. Shift work interfering with the establishment of regular sleep patterns F. Previous or ongoing cognitive behavioral therapy for insomnia

Primary outcomes:
measure: Insomnia Severity Index (Total), Change From Baseline to Follow-up
timeFrame: pre-intervention, intervention completion (expected average of 7 weeks)
measure: Completion of All 7 Modules of the Intervention
timeFrame: on average 7 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: West Haven
country: United States
facility: VA Connecticut Healthcare System
state: Connecticut
Study officials:
References:
Clinical trial NCT01889589: NYC Heart Follow-Up Study 2010
Official title: Baseline 24 Hour Urine Collection in Population-based Sample of NYC Adults
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sodium
Lead sponsor: New York City Department of Health and Mental Hygiene
Sponsor class: OTHER_GOV
First posted: 2013-06-28
Enrollment: 1775
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: NYC adult population

Brief summary: This surveillance project will assess NYC population sodium intake using the gold standard measurement of 24-hour urine collection. This surveillance project is a critical component of a larger initiative, coordinated by NYC, to reduce sodium intake nationwide through voluntary industry reductions in processed food sodium content. The project will assess current population sodium intake, against which population intake changes at three years can be assessed


Eligibility criteria: Inclusion Criteria:

* \> 18 Years

Exclusion Criteria:

* Pregnant, breastfeeding or lactating; past or current dialysis

Primary outcomes:
measure: 24-hour urinary sodium
timeFrame: 24-hour period
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
state: New York
Study officials:
References:
citation: Elfassy T, Yi SS, Llabre MM, Schneiderman N, Gellman M, Florez H, Prado G, Zeki Al Hazzouri A. Neighbourhood socioeconomic status and cross-sectional associations with obesity and urinary biomarkers of diet among New York City adults: the heart follow-up study. BMJ Open. 2017 Dec 29;7(12):e018566. doi: 10.1136/bmjopen-2017-018566.
citation: Loftfield E, Yi S, Curtis CJ, Bartley K, Kansagra SM. Potassium and fruit and vegetable intakes in relation to social determinants and access to produce in New York City. Am J Clin Nutr. 2013 Nov;98(5):1282-8. doi: 10.3945/ajcn.113.059204. Epub 2013 Sep 11.
Clinical trial NCT06531889: Core Stabilization Exercises on Shoulder Impingement Syndrome
Official title: Core Stabilization Exercises in Shoulder Impingement Syndrome: A Preliminary Retrospective Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Subacromial Impingement Syndrome
Lead sponsor: Acibadem University
Sponsor class: OTHER
Collaborators: name: Yeditepe University
First posted: 2024-08-01
Enrollment: 50
Sex: ALL
Minimum age (years): 35
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The objective of this retrospective study was to look into the effects of core stabilization exercises applied in conjunction with classic physiotherapy program on pain, muscle strength, disability, and posture in SIS.


Eligibility criteria: Inclusion Criteria:

* Patients between the ages of 35 and 60 who were diagnosed by a Physical Therapy and Rehabilitation doctor with at least ten years of experience, whose SIS was confirmed by MRI, and who had shoulder complaints for at least three months, patients with positive signs, a positive Hawkins-Kennedy test, significant loss of active and passive shoulder movements or painful range of motion (ROM), and patients whose treatment and evaluation methods were appropriate for the study design were enrolled in the study

Exclusion Criteria:

* Patients who had upper extremity surgery, patients with a history of shoulder trauma and corticosteroid application to the shoulder region in the previous year, a history of shoulder dislocation, infection, tumor, adhesive capsulitis, reflex sympathetic dystrophy, congenital anomaly, rheumatic disease, and chronic severe systemic disease, as well as professional athletes and patients whose evaluations were missing in the previous month were excluded

Primary outcomes:
measure: The Numerical Rating Scale (NPRS-11)
timeFrame: Change from baseline pain score at 6th week
measure: New York Posture Rating Method to determine their postures
timeFrame: Change from baseline pain score at 6th week
measure: Shoulder pain and disability index
timeFrame: Change from baseline score of The Shoulder Pain and Disability Index at 6th week
Secondary outcomes:
measure: Shoulder mobility on the Shoulder Range of Motion
timeFrame: Change from baseline range of motion at 6th week
measure: Core muscle strength test
timeFrame: Change from baseline strenght score at 6th week
measure: Endurance of Core Muscles
timeFrame: Change from baseline endurance score at 6th week
measure: Manual muscle test
timeFrame: Change from baseline manual muscle testing score at 6th week
Other outcomes:
Locations:
city: İ̇stanbul
country: Turkey
facility: Yeditepe University
Study officials:
affiliation: Acibadem University
name: Nuray ALACA
role: STUDY_DIRECTOR
References:
Clinical trial NCT01086189: Does Green Tea Affect Postprandial Glucose, Insulin and Satiety in Healthy Subjects
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes Type 2
Obesity
Lead sponsor: Skane University Hospital
Sponsor class: OTHER
First posted: 2010-03-12
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CROSSOVER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 14 healthy volunteers

Brief summary: Green tea consumption could lower the risk of type II diabetes, as suggested by epidemiological studies. There is also evidence from intervention studies that green tea can decrease blood glucose levels and contribute to weight loss.

The aim with this study is therefore to examine the postprandial effects of green tea on glycemic index, insulin levels and satiety in healthy individuals after the consumption of a meal.

Detailed description: The study was conducted on 14 healthy volunteers, with a crossover design. Participants were randomized to either green tea or water. This was consumed together with a breakfast consisting of white bread. Blood samples were drawn at 0, 15, 30, 45, 60, 90 and 120 minutes. Participants completed two different satiety scores at the same time intervals.

Eligibility criteria: Inclusion Criteria:

* Healthy subjects

Exclusion Criteria:

* Diabetes

Primary outcomes:
measure: Postprandial glucose and insulin
Secondary outcomes:
measure: Postprandial satiety
Other outcomes:
Locations:
city: Malmo
country: Sweden
facility: Skane University Hospital
state: Skane
Study officials:
References:
citation: Josic J, Olsson AT, Wickeberg J, Lindstedt S, Hlebowicz J. Does green tea affect postprandial glucose, insulin and satiety in healthy subjects: a randomized controlled trial. Nutr J. 2010 Nov 30;9:63. doi: 10.1186/1475-2891-9-63.
Clinical trial NCT01953289: Importance of Peritoneal Free Fluid Cultures in Acute Appendicitis
Official title: Importance of Peritoneal Free Fluid Cultures in Both Perforated and Non-perforated Appendicitis
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Appendicitis
Keywords: Appendicitis
Free fluid
Lead sponsor: Universitaire Ziekenhuizen KU Leuven
Sponsor class: OTHER
First posted: 2013-09-30
Enrollment: 0
Sex: ALL
Minimum age (years): 6
Maximum age (years): 90
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with perforated or non-perforated appendicitis

Brief summary: The purpose of this study is to evaluate the frequency of positive free fluid cultures in both perforated and non-perforated appendicitis. In addition predictors of positive free fluid cultures will be analyzed.

Detailed description: Prior to surgery, all patients will receive antibioprophylaxis. In case of free peritoneal fluid, a sample is aspirated and sent for microbiology. A lavage with saline is not necessary. The decision to start postoperative antibiotic is left at the discretion of the surgeon. The decision to leave an abdominal drain is left at the discretion of the surgeon.

The use of a preoperative single dose administration of antibiotics has been extensively studied and found beneficial in the prevention of SSI in appendicitis. However, the use of continued postoperative antibiotics has barely been studied. The sparse evidence that exist does not seem to support its systematic use. During appendectomy the surgeon frequently encounters turbid free fluid, even in non-perforated appendicitis. It is common practice in Belgium to continue antibiotic prophylaxis for 5 days after aspiration and lavage. Although the aspect often seems purulent, it is unknown in what percentage this fluid is contaminated. Also, it is unknown whether after aspiration and lavage intra-abdominal drains are necessary.

Eligibility criteria: Inclusion Criteria:

* Appendicitis (Perforated/ Non-perforated) Free fluid Age: 6 - 90y

Exclusion Criteria:

* Immunosuppression (recent chemotherapy, chronic use of immunosuppressive medication) Age \< 6 and \> 90y

Primary outcomes:
measure: To evaluate the frequency of positive free fluid cultures in both perforated and non-perforated appendicitis
timeFrame: 24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: University Clinics Gasthuisberg
state: Flemish Brabant
Study officials:
affiliation: university Clinics Gasthuisberg department of abdominal surgery
name: André JL D'Hoore, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02414789: Lyme Borreliosis and Early Cutaneous Diagnostic
Official title: Lyme Borreliosis and Early Cutaneous Diagnostic
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Erythema Migrans
Keywords: erythema migrans
Lyme
early diagnosis
skin biomarkers
proteomics diagnostic
mass spectrometry
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2015-04-13
Enrollment: 84
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: Test and evaluate a new diagnostic method (SRM-MS/MS: Selected Reaction Monitoring- Mass spectrometry) for Lyme Borreliosis on human skin biopsies. Patients included are those with the early skin manifestation (erythema migrans).

This new proteomic method will be compared to the two existing method: culture of Borrelia and PCR detection of Borrelia (DNA detection of the bacteria).


Eligibility criteria: Inclusion Criteria:

* Erythema migrant as criteria EUCALB or atypical form associated to tick's sting
* Patient having signed a consent
* Patient affiliated to a social security scheme

Exclusion Criteria:

* Prior treatment with antibiotics
* Erythema migrans on the face
* Bleeding disorders
* Anticoagulant treatment
* Inability to give clear information (subject in an emergency situation, understanding of the topic difficulty, ...)

Primary outcomes:
measure: Compare the sensitivity (percentage of positive tests) of the SRM / MS-MS to techniques of PCR and culture Borrelia
timeFrame: One year study
Secondary outcomes:
Other outcomes:
Locations:
city: Besancon
country: France
facility: Centre Hospitalo-Universitaire Jean Minjoz
city: Chalon-sur-Saône
country: France
facility: Centre Hospitalier William Morey
city: Colmar
country: France
facility: Hôpital Pasteur
city: Mulhouse
country: France
facility: Hôpital E. Muller
city: Reims
country: France
facility: Hôpital Robert Debré
city: Strasbourg
country: France
facility: Hôpitaux Universitaires de Strasbourg
city: Thionville
country: France
facility: Hôpital Bel Air
Study officials:
References:
Clinical trial NCT03054389: Non-Interventional Study to Capture the Patient Experience on Gene Therapy for Hemophilia Within the AskBio009-101 Study Through Patient and Investigator Interviews
Official title: Non-Interventional Study to Capture the Patient Experience on Gene Therapy for Hemophilia Within the AskBio009-101 Study Through Patient and Investigator Interviews
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hemophilia B
Lead sponsor: Takeda
Sponsor class: INDUSTRY
First posted: 2017-02-15
Enrollment: 27
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Investigators, Study Coordinators, and Participants from the AskBio009-101 Study

Brief summary: The purpose of this study is to seek to understand the patient's perspective around deciding to participate in a clinical trial for a Hemophilia therapy


Eligibility criteria: Inclusion criteria for patients:

* Were screened and consented for the AskBio009-101study at any point in time
* Are able to speak and understand English
* Are between ages of 18 and 75
* Are physically able to participate in a one-hour phone interview
* Consented into this study independently of the AskBio009-101 study

Exclusion criteria for patients:

- N/A

Inclusion criteria for investigators and coordinators:

* Worked at a site as an investigator or study coordinator that consented a patient into the
* AskBio009-101 trial at any point in time, including those that no longer work at a AskBio009-101 site
* Are able to speak and understand English
* Are between ages of 18 and 75
* Are physically able to participate in a one-hour phone interview

Exclusion criteria for investigators and coordinators:

- Not directly involved in the consent process at the gene therapy site

Primary outcomes:
measure: Interview - AskBio009-101 Study - Participants/ Patients
timeFrame: Approximately 1 hour
measure: Interview - AskBio009-101 Study - Investigators and Study Coordinators
timeFrame: Approximately 1 hour
Secondary outcomes:
Other outcomes:
Locations:
city: Cambridge
country: United States
facility: QuintilesIMS
state: Massachusetts
Study officials:
affiliation: Takeda
name: Study Director
role: STUDY_DIRECTOR
References: