louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03602417: Flare Type Self-expandable Metal Stent for Malignant Colorectal Obstruction
Official title: Comparison of Flare Type Self-expandable Metal Stent With Conventional D-type Self-expandable Metal Stent for Malignant Colorectal Obstruction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colorectal Cancer
Keywords: colorectal cancer
stent
Lead sponsor: Kyungpook National University Hospital
Sponsor class: OTHER
First posted: 2018-07-26
Enrollment: 61
Sex: ALL
Minimum age (years): 19
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study compares flare type self-expandable metal stent with conventional D-type self-expandable metal stent for malignant colorectal obstruction.


Eligibility criteria: Inclusion Criteria:

* Malignant colorectal obstruction confirmed by radiologic study

Exclusion Criteria:

* Bowel perforation
* Multiple obstruction
* Benign obstruction
* Pregnancy

Primary outcomes:
measure: Clinical success rate
timeFrame: 48 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Daegu
country: Korea, Republic of
facility: Kyungpook National University Hospital
Study officials:
References:
Clinical trial NCT01679717: Postoperative Therapy After Interposition Arthroplasty in CMC1
Official title: Postoperative Therapy After Interposition Arthroplasty in CMC1
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Thumb Osteoarthritis
Keywords: Osteoarthritis
CMC1-joint
Postoperative therapy
Interposition arthroplasty of the thumb
Occupational therapy
Lead sponsor: Diakonhjemmet Hospital
Sponsor class: OTHER
Collaborators: name: The Norwegian Women´s Public Health Association
First posted: 2012-09-06
Enrollment: 70
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: In this randomized controlled trial the investigators want to investigate whether early versus late mobilisation after surgery in the first carpometacarpal joint (CMC1) leads to a faster recovery of hand function. The investigators also want to explore patients' satisfaction with the two different treatment regimes. The participants in the control group will receive the standard treatment at Diakonhjemmet hospital: immobilisation of the thumb in a splint for six weeks. The participants in the intervention group will use a soft splint for six weeks, but will be instructed to remove the splint daily to perform exercises for the thumb. A total of 70 patients will be included in the study.


Eligibility criteria: Inclusion Criteria:

* Osteoarthritis in CMC1 diagnosed by radiography and a surgeon.
* Planned surgery(interposition arthroplasty) in CMC1
* Ability to communicate in Norwegian

Exclusion Criteria:

* Surgery involving other joints of the hand in addition to CMC1.
* Previous surgery of the same thumb.
* Other diseases og injuries that could influence hand function.
* Mental or cognitive deficit.

Primary outcomes:
measure: Change from baseline in The Canadian Occupational Performance Measure (COPM) at 3, 6 and 12 months.
timeFrame: Baseline, 3, 6 and 12 months
measure: Change from baseline in Patient satisfaction with the rehabilitation regimen at 3, 6 and 12 months.
timeFrame: Baseline, 3, 6 and 12 months
Secondary outcomes:
measure: Measure for activity performance (MAP-hand).
timeFrame: Baseline, 3, 6 and 12 months
measure: Grip force and pinch grip
timeFrame: Baseline, 3, 6 and 12 months
measure: Joint mobility
timeFrame: Baseline, 3, 6 and 12 months
measure: Pain
timeFrame: Baseline, 3, 6, and 12 months
Other outcomes:
measure: Training diary
timeFrame: Intervention group: 2-6 weeks and 3-4 months. Control group: 6-10 weeks and 3-4 months.
Locations:
city: Oslo
country: Norway
facility: Diakonhjemmet hospital
Study officials:
affiliation: Department of Rheumatology, Diakonhjemmet hospital
name: Ingvild Kjeken, Ph.d
role: STUDY_CHAIR
References:
Clinical trial NCT05625217: Total-Body FDG PET for Radiotherapy Response Assessment in Head and Neck Cancer
Official title: Characterizing Dynamics of FDG Uptake With Total-Body PET for Response Assessment in Radiotherapy for Head and Neck Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Head and Neck Cancer
Lead sponsor: University of California, Davis
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2022-11-22
Enrollment: 7
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The overall goal of this research study is to understand how 18F-fluorodeoxyglucose (FDG), a radioactive sugar behaves in head and neck cancer (HNC) and inflammation immediately following injection and at many hours post-injection, with the world's first total-body positron emission tomography (PET)/computed tomography (CT) scanner (EXPLORER).


Eligibility criteria: Inclusion Criteria:

1. Stage II-IVa (American Joint Committee on Cancer, 8th edition) OC who are planned for RT (≥60 Gy) as per routine clinical standard.
2. Patient must be ≥18 years of age.
3. Willing and able to lay motionless in a supine position for up to 60 minutes
4. Patient must be able to provide study specific informed consent prior to study entry.
5. Patient must be able to adhere to the study visit schedule and other protocol requirements (including prolonged fasting).

Exclusion Criteria:

1. Prior RT for any malignancy leading to overlap with planned RT fields.
2. Prior chemotherapy for any malignancy.
3. Subjects suffering from severe claustrophobia.
4. Subjects who have had a research study involving radiation within one year of enrolling in this study
5. Subjects who are pregnant (subjects 18 to 60 years old who are able to become pregnant unless documented hysterectomy or bilateral ovarian removal is available will be tested prior to injection of imaging agent - positive test will exclude from participating in the study)
6. Subjects who are breastfeeding
7. Prisoners.
8. Any significant medical condition that in the opinion of the investigator would prevent the subject from participating and/or adhering to study related procedures or interfere with subject safety (e.g., poorly controlled diabetes).
9. Children (\<18 years of age).
10. Body weight more than 240 kg (529 pounds)

    -

Primary outcomes:
measure: Utility of long-delayed FDG PET Imaging
timeFrame: Percent change from baseline to 2 hour post injection
Secondary outcomes:
Other outcomes:
Locations:
city: Sacramento
country: United States
facility: UC Davis EXPLORER Molecular Imaging Center
state: California
Study officials:
affiliation: University of California, Davis
name: Tokihiro Yamamoto, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02471417: Acute Dietary Nitrate in Dilated Cardiomyopathy
Official title: Dietary Nitrate Supplementation in Dilated Cardiomyopathy: An Acute, Double-blind, Randomized, Placebo-controlled, Crossover Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiomyopathy
Lead sponsor: Royal College of Surgeons, Ireland
Sponsor class: OTHER
Collaborators: name: University College Dublin
name: Connolly Hospital Blanchardstown
First posted: 2015-06-15
Enrollment: 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

Brief summary: Acute consumption of dietary nitrate (as beetroot juice) has been shown to improve exercise capacity in athletes, healthy adults and subjects with both peripheral vascular disease or COPD. Many patients with dilated cardiomyopathy have reduced exercise capacity, The investigators hypothesized that acute nitrate consumption might increase incremental shuttle walk test (ISWT) distance in dilated cardiomyopathy subjects compared to a placebo beetroot juice.

Detailed description: Acute consumption of dietary nitrate (as beetroot juice) has been shown to improve exercise capacity in athletes, healthy adults and subjects with both peripheral vascular disease or COPD. Many patients with dilated cardiomyopathy have reduced exercise capacity, The investigators hypothesized that acute nitrate consumption might increase incremental shuttle walk test (ISWT) distance in dilated cardiomyopathy subjects compared to a placebo beetroot juice. This study is a randomized, double-blind placebo-controlled, crossover trial. Resting blood pressure, phlebotomy and ISWT will be performed. Following completion, each subject is randomized to consume beetroot juice or placebo. 3 hours later, the same assessments are repeated by the same people. After a 7d washout, the entire protocol is repeated with the crossover beverage.

Eligibility criteria: Inclusion Criteria:

* Clinically stable,
* Confirmed non-ischemic, dilated cardiomyopathy

Exclusion Criteria:

* Active musculo-skeletal conditions
* Ischemic heart disease
* Pulmonary hypertension
* COPD
* Taking vasodilators
* Diabetes mellitus

Primary outcomes:
measure: Change between incremental shuttle walk test distance pre and post juice
timeFrame: Day 1 and day 8
Secondary outcomes:
measure: Clinic blood pressure
timeFrame: Day 1 and day 8
measure: Plasma nitrate
timeFrame: Day 1 and day 8
measure: Dyspnoea using self report, validated Borg scale
timeFrame: Day 1 and day 8
measure: Oxygen saturation using pulse oximetry
timeFrame: Day 1 and day 8
measure: Plasma nitrite
timeFrame: Day 1 and day 8
Other outcomes:
Locations:
Study officials:
affiliation: Connolly Hospital Blanchardstown
name: Jim O 'Neill, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00329017: Protocol for Postmenopausal Women at Increased Risk of Developing Breast Cancer
Official title: Correlation of SNP Patterns With Fine Needle Aspiration Cytomorphology in High Risk Postmenopausal Women
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Breast Cancer
Keywords: SNPs
single nucleotide polymorphism
breast atypia
breast epithelial hyperplasia
high risk for breast cancer
Lead sponsor: University of Kansas Medical Center
Sponsor class: OTHER
Collaborators: name: Intergenetics, Inc.
First posted: 2006-05-24
Enrollment: 0
Sex: FEMALE
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: Post menopausal women, on or off hormone replacement therapy, at high risk of developing breast cancer

Brief summary: A study to examine the potential associations between common single nucleotide polymorphisms and pre-cancerous conditions in breast tissue specimens from postmenopausal women.

Detailed description: A study to examine the correlation between single nucleotide polymorphisms (SNPs) affecting steroid and carcinogen metabolism and benign breast tissue cytomorphology collected via random periareolar fine needle aspiration in postmenopausal women at increased risk for breast cancer and taking hormone replacement therapy.

Eligibility criteria: Inclusion Criteria:

* postmenopausal women on or off hormone replacement therapy
* at high risk of developing breast cancer determined by family or personal history
* postmenopausal women not on hormone replacement therapy for at minimum six months prior to corresponding aspiration
* willing to participate in companion protocol (KUMC HSC#4601) for random periareolar fine needle aspiration (RPFNA) for correlational studies

Exclusion Criteria:

* women who have been on raloxifene, tamoxifen, letrozole, anastrozole or exemestane within the six months prior to RPFNA.

Primary outcomes:
measure: Correlation of SNP patterns with cytlomorphology of breast fine needle aspirates.
timeFrame: ongoing
Secondary outcomes:
Other outcomes:
Locations:
city: Kansas City
country: United States
facility: University of Kansas Medical Center
state: Kansas
Study officials:
affiliation: University of Kansas Medical Center
name: Carol J Fabian, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00898417: Biomarker Study of Blood Samples From Patients With Non-Small Cell Lung Cancer Treated With Carboplatin and Paclitaxel With or Without Bevacizumab
Official title: Development of a Serum Proteomic Classifier for the Prediction of Benefit From Bevacizumab in Combination With Carboplatin and Paclitaxel
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lung Cancer
Keywords: stage IIIB non-small cell lung cancer
recurrent non-small cell lung cancer
stage IV non-small cell lung cancer
adenocarcinoma of the lung
bronchoalveolar cell lung cancer
Lead sponsor: Eastern Cooperative Oncology Group
Sponsor class: NETWORK
Collaborators: name: National Cancer Institute (NCI)
First posted: 2009-05-12
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Samples submitted for research from patients participating in E4599

Brief summary: RATIONALE: Studying samples of blood in the laboratory from patients undergoing treatment for non-small cell lung cancer may help doctors predict how patients will respond to treatment.

PURPOSE: This laboratory study is looking at proteomic patterns in stored blood samples from patients undergoing treatment for non-small cell lung cancer.

Detailed description: OBJECTIVES:

Primary

* To develop a serum proteomic classifier using matrix-assisted laser-desorption/ionization time-of-flight mass spectrometry analysis of blood samples from patients with non-squamous cell non-small cell lung cancer to predict benefit, in terms of survival and time to progression, from treatment with bevacizumab in combination with carboplatin and paclitaxel.

Secondary

* To better quantitate candidate biomarkers by using more advanced mass spectrometric technologies, including multiple-reaction monitoring and heavy-labeled peptides.

OUTLINE: Previously collected pre-treatment samples of serum or plasma are randomly selected from patients enrolled on protocol ECOG-4599 (i.e., 60 from the bevacizumab arm and 30 from the control arm). Samples are analyzed by matrix-assisted laser-desorption/ionization time-of-flight mass spectrometry to identify patterns from protein spectra that correlate with patient survival.

Eligibility criteria: DISEASE CHARACTERISTICS:

* Available serum and plasma samples from patients with previously untreated locally advanced, metastatic, or recurrent non-squamous cell non-small cell lung cancer
* Enrolled on clinical trial ECOG-4599

  * Treated with carboplatin and paclitaxel with or without bevacizumab

PATIENT CHARACTERISTICS:

* Not specified

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics

Primary outcomes:
measure: Survival
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Vanderbilt-Ingram Cancer Center
name: David P. Carbone, MD, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT06298617: Systemic Inflammatory Indices as a Non-invasive Grading Modality for Endometriosis
Official title: Systemic Inflammatory Indices as a Non-invasive Grading Modality for Endometriosis: A Comparative Study Versus Exploratory Laparoscopy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Endometriosis
Lead sponsor: Benha University
Sponsor class: OTHER
First posted: 2024-03-07
Enrollment: 88
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All women attending the outpatient of Gynecology department with clinical picture suggestive of having EM or had previously diagnosed depending on radiologic workup were evaluated for the enrolment criteria.

Brief summary: Endometriosis (EMs) is one of the commonest chronic inflammatory disorder affecting women and is characterized by the presence and growth of endometrial-like glandular epithelial and stromal cells outside the uterus leading to multiple clinical symptoms affecting patients quality of life and fertility with high recurrence rate . The systemic immune inflammatory index (SII) and systemic inflammatory response index (SIRI) are documented as prognostic serum biomarker in many kinds of cancer and for the need and outcomes of adjuvant therapies for various cancers .


Eligibility criteria: Inclusion Criteria:

* Women with clinical manifestations suggestive of having EM;
* Women who was professionally diagnosed;
* Women who was diagnosed by radiologic workup;
* Women were free of exclusion criteria.

Exclusion Criteria:

* Women with EM and were maintained on treatment or underwent operative interference during the last three months;
* Patients had autoimmune diseases, maintained on immunosuppressive therapy for any indication;
* Women with cancer elsewhere in the body or receiving adjuvant therapies for cancer;
* Patients receiving therapies for viral disorders especially COVID;
* Patients refusing to undergo the exploratory laparoscopy.

Primary outcomes:
measure: Indices' ability to predict EM stage
timeFrame: 8 months
Secondary outcomes:
Other outcomes:
Locations:
city: Banhā
country: Egypt
facility: Benha University
state: Al Qalyobia
Study officials:
References:
Clinical trial NCT02710617: System Accuracy Evaluation of 2 CE-marked Blood Glucose Monitoring System
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes
Lead sponsor: Institut für Diabetes-Technologie Forschungs- und Entwicklungsgesellschaft mbH an der Universität Ulm
Sponsor class: OTHER
First posted: 2016-03-17
Enrollment: 109
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes

Brief summary: The objective of this study is the evaluation of system accuracy following ISO 15197:2013 (E), clause 6.3 in which accuracy requirements and applicable test procedures for blood glucose monitoring systems intended for self-monitoring of blood glucose by patients are stipulated.

However in this study, system accuracy evaluation will be performed for Hemocue Glucose 201+ and Hemocue Glucose 201 RT which are both glucose monitoring systems for professional use only on behalf of the IDT with one reagent system lot for each BGMS.

Main goal is the evaluation of system accuracy of both of the hemocue Systems. (english)


Eligibility criteria: Inclusion Criteria:

* Male or female, with type 1 diabetes, type 2 diabetes or subjects without diabetes
* Signed informed consent form
* Minimum age of 18 years
* Subjects are legally competent and capable to understand character, meaning and consequences of the study.
* If blood glucose values \< 80 mg/dl or \> 300 mg/dl shall be measured after short term alteration in insulin therapy:
* Male or female with type 1 diabetes and intensified insulin therapy or insulin pump therapy.
* Signature of subjects to document consent with these procedures on informed consent form.

Exclusion Criteria:

* Pregnancy or lactation period
* Severe acute disease (at the study physician's discretion)
* Severe chronic disease with potential risk during the test procedures (at the study physician's discretion)
* Current constitution that compromises the subject's capability to participate in the study (at the study physician's discretion)
* Being unable to give informed consent
* \< 18 years
* Legally incompetent
* Being committed to an institution (e.g. psychiatric clinic)
* Language barriers potentially compromising an adequate compliance with study procedures
* Dependent on investigator or sponsor
* If blood glucose values \< 80 mg/dl shall be measured after short term alteration in insulin therapy (concentration category 2, see Fehler! Verweisquelle konnte nicht gefunden werden.), subjects with type 1 diabetes, suffering from:
* Coronary heart disease
* Condition after myocardial infarction
* Condition after cerebral events
* Peripheral arterial occlusive disease
* Hypoglycemia unawareness

Primary outcomes:
measure: System accuracy criteria (see description)
timeFrame: For each subject, the experimental phase has an expected duration of up to 6 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Ulm
country: Germany
facility: Institut für Diabetes-Technologie Forschungs- und Entwicklungsgesellschaft mbH an der Universität Ulm
Study officials:
References:
Clinical trial NCT00906217: Safety, Efficacy, and Tolerance of Pico-Salax for Colon Cleansing Prior to Colonoscopy in an Elderly Population
Official title: Safety, Efficacy, and Tolerance of Pico-Salax for Colon Cleansing Prior to Colonoscopy in an Elderly Population
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Colon Cleansing
Keywords: colonoscopy
preparation
safety
elderly
Lead sponsor: Queen's University
Sponsor class: OTHER
First posted: 2009-05-21
Enrollment: 50
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients older than 70 scheduled for colonoscopy

Brief summary: This study aims to further define the appropriate population for Pico-Salax, a purgative used prior to colonoscopy. Patients over the age of 70 years with normal renal function scheduled for colonoscopy will receive Pico-Salax and have pre and post preparation bloodwork and electrocardiograms (ECGs).


Eligibility criteria: Inclusion Criteria:

* \>70 years

Exclusion Criteria:

* renal dysfunction
* congestive heart failure
* ileus

Primary outcomes:
measure: serum electrolyte changes pre and post preparation
timeFrame: 2 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Queen's University
name: Lawrence Hookey, MD
role: PRINCIPAL_INVESTIGATOR
References: