louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00514566: PDS vs Polyamide for Midline Abdominal Closure
Official title: Is Polydioxanone 'THE' Suture of Choice for Midline Abdominal Closure? Results of a Prospective Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Laparotomy
Keywords: Polyamide
Polydioxanone
Midline
Abdominal
Closure
Lead sponsor: Christian Medical College and Hospital, Ludhiana, India
Sponsor class: OTHER
First posted: 2007-08-10
Enrollment: 64
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Within the last decade the customary trend of using non absorbable sutures has changed, with numerous studies and meta-analyses advocating the use of slowly absorbable sutures, claiming comparable wound strength with significantly lower incidence of wound complications. It was the objective of this randomized clinical trial to compare two universally accepted suture materials, the non-absorbable Nylon and the slowly absorbable Polydioxanone for midline abdominal closure in the Indian context.

Detailed description: 64 patients undergoing midline laparotomy were allocated, using block randomization, to mass closure of the abdominal wall with continuous polyamide (34 patients) or continuous polydioxanone (30 patients).

There was an alarmingly higher incidence of wound dehiscence in the PDS group requiring secondary suturing (Nylon 0; PDS 5). Mid-way through the trial, an interim analysis was performed which revealed an unacceptably high incidence of wound dehiscence in the PDS group. This necessitated a premature curtailment of the study. There was, however, a statistically significantly higher incidence of scar pain in the Nylon group (Nylon 9; PDS 1).

There is a need for a study with larger series, and PDS as a choice of suture for midline wound closure cannot be recommended.

Eligibility criteria: Inclusion Criteria:

* All patients above 12 years of age undergoing midline abdominal fascial closure using a continuous technique in the Department of Surgery, Christian Medical College and Hospital

Exclusion Criteria:

* All patients under 12 years of age
* Gynaecological operations
* Abdominal wall hernia repair

Primary outcomes:
measure: Wound Complications associated with suture material used for closure- Wound Dehiscence, Wound Infection, Incisional Hernia, Suture Sinus, Scar Pain
timeFrame: 2 years
Secondary outcomes:
measure: Factors independent of suture materials responsible for wound complications such as age, gender, type of surgery, degree of contamination, surgeon, and presence of a stoma
timeFrame: 2 years
Other outcomes:
Locations:
city: Ludhiana
country: India
facility: Christian Medical College and Hospital
state: Punjab
Study officials:
affiliation: Christian Medical College and Hospital, Ludhiana, India
name: Rajeev Kapoor, MS(Gen Surg)
role: STUDY_CHAIR
References:
Clinical trial NCT05372666: Glycaemic Index of Fibre-rich Flours in Healthy Volunteers
Official title: Study of the Glycaemic Index of Breads Made From Flour Naturally Rich in Fibre in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Lead sponsor: Paulic Meunerie SA
Sponsor class: INDUSTRY
Collaborators: name: Institut Polytechnique UniLaSalle
First posted: 2022-05-13
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Latin square randomization for test products following reference treatment (as per standard protocol)
Primary purpose: OTHER

Brief summary: The project aims to evaluate the glycaemic index of breads from different types of flour. In particular, we aim to understand the glycaemic and insulin responses as well as satiety and sensory profiles of the products.


Eligibility criteria: Inclusion Criteria:

* Having a Body Mass Index (BMI) between 18.5 and 30 kg/m²
* Non-smoker for more than three months
* Having signed the informed consent form
* Likely to follow the constraints generated by the study (one morning per week for 9 weeks)
* Social insurance

Exclusion Criteria:

* Pregnant woman
* Subject with a known progressive somatic or psychiatric disease
* Fasting blood glucose greater than 6.1 mmol/L (1.10 g/L), postprandial blood glucose greater than 7.7 mmol/L (1.4 g/L) or known diabetes treated or untreated
* Hyperinsulinemia or a history of insulinoma
* HbA1c greater than 7 %
* History of hypercholesterolemia, hypertension, diabetes or glucose intolerance
* History of food allergy or digestive pathology likely to affect digestion or absorption
* Renal failure
* ASAT or ALAT elevation beyond 1.5 times the upper limit
* Subject consuming more than three glasses per day of alcohol or suffering from various addictions
* Weight change of more than 3 kg in the last three months
* Person participating in another clinical study, or in a period of exclusion from another study
* Person deprived of liberty or under judicial protection

Primary outcomes:
measure: Glycaemic index
timeFrame: glycemia measured over 120 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Amiens
country: France
facility: Centre de recherche clinique - Centre Hospitalo Universitaire
Study officials:
References:
Clinical trial NCT01715766: VIPER: Veterans Integrated Pain Evaluation Research
Official title: VIPER: Veterans Integrated Pain Evaluation Research- Molecular Subtypes of Chronic Pain Syndromes
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pain
Keywords: Proteomics study
biomarker study of pain
Lead sponsor: Defense and Veterans Center for Integrative Pain Management
Sponsor class: OTHER
Collaborators: name: Duke University
First posted: 2012-10-29
Enrollment: 124
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: Male and female active duty military personnel age 18 years and older presenting with the diagnosis of amputation of 1 limb in the previous 18 months. At least 3 months must have passed since the first amputation procedure.

Brief summary: The purpose of the study is to learn about the causes of different types of pain that can occur in people who have had an amputation. By gathering information through blood tests, photographs, a nerve test, and questionnaires, we hope to de-code how each individual's special characteristics affect the type and amount of pain they experience in their amputated limb.

Detailed description: Studies have already shown that pain following amputation might be caused by differences in a person's genes. This study may help us find out how genes affect the way you feel pain and why you may feel more or less or different kinds of pain than another person with a similar amputation. What we learn in this research study may lead to discoveries as to why some painkillers work better for some people than others.

Eligibility criteria: Inclusion Criteria:

* Male and female active duty military personnel age 18 years and older undergoing treatment at WRAMC and future WRNMMC with the diagnosis of post injury amputation of 1 limb, more than 3 but less than 18 months prior to enrollment. In particular, phantom limb pain patients will be included

Exclusion Criteria:

* Severe Traumatic Brain Injury (Primary major head trauma and diagnosis of traumatic brain injury resulting in documented, permanent or prolonged cognitive deficits that would preclude participation in the study (i.e. decreased intellectual capacity, marked memory deficits, or inability to communicate verbally or in writing)
* Significant cognitive deficits that would preclude participation in the study.
* Substantial hearing loss without alternative means of communication.
* Documented spinal cord injury with permanent or persistent deficits.
* Diagnosis of fibromyalgia or other chronic pain syndrome such as chronic headaches.
* Evidence of ongoing tissue damage pain, infection, bone spur, or poorly fitting prosthesis.

Primary outcomes:
measure: Proteomics
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Bethesda
country: United States
facility: Walter Reed National Military Medical Center
state: Maryland
Study officials:
References:
Clinical trial NCT02101866: A Study to Compare the Oral Bioavailability of Single Doses of Two Vapendavir Drug Formulations in Healthy Volunteers
Official title: A Randomized, Single-Center, Open-Label, Two-Period, Two-Sequence, Crossover, Comparative Study to Compare the Oral Bioavailability of Single Doses of Two Vapendavir Drug Product Formulations in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Bioavailability Study
Aviragen Therapeutics, Inc.
Aviragen Therapeutics
Aviragen
Lead sponsor: Vaxart
Sponsor class: INDUSTRY
First posted: 2014-04-02
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: This Phase 1 study aims to determine the oral bioavailability of a single dose of a new vapendavir tablet formulation and compare it to that of the previous vapendavir capsule formulation. The safety of both drug products will also be assessed.


Eligibility criteria: Inclusion Criteria:

* Must be male or female between 18 and 55 years of age (inclusive) with BMI between 18 and 30 kg/m2 (inclusive), and weight ≥50 kg at the time of screening
* Capable of giving written informed consent
* Subject is able to understand and comply with the protocol requirements, instructions and restrictions
* Healthy on the basis of physical examination, medical history, medication usage, VS, ECGs, and clinical laboratory tests
* Female subjects must be of non-childbearing potential
* Male subjects must agree to use a double barrier method of birth control

Exclusion Criteria:

* Positive results for Hepatitis B, Hepatitis C, or HIV
* Frequent use of tobacco products, including cigarettes, cigars, chewing tobacco
* A medical history of significant hematological, gastrointestinal, respiratory, renal, hepatic, cerebrovascular, immunologic, psychiatric or cardiovascular disease or event; Current or recent respiratory infection
* Presence or history of significant allergy
* Clinically significant abnormalities noted on ECG
* Screening vital signs representing sustained elevated blood pressure
* Presence of significant gastrointestinal abnormalities
* Safety laboratory abnormalities noted at screening which are clinically significant
* Current or defined history of abuse of alcohol or illicit drugs
* A positive pregnancy test at screening
* Poor vein access or fear of venipuncture or sight of blood

Primary outcomes:
measure: Systemic exposure profile of a single dose of a vapendavir 300 mg tablet compared to the exposure profile following a single dose of two 132 mg vapendavir capsules
timeFrame: maximum up to 46 days
Secondary outcomes:
Other outcomes:
Locations:
city: Saint Paul
country: United States
facility: Investigative Site
state: Minnesota
Study officials:
affiliation: Prism Research, Inc
name: Mark Matson, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03111966: Effectiveness, Safety and Clinical Outcomes of Elbasvir/Grazoprevir: Results From a Spanish Real World Cohort
Official title: Effectiveness, Safety and Clinical Outcomes of Elbasvir/Grazoprevir: Results From a Spanish Real World Cohort
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hepatitis C
Keywords: Hepatitis C
Lead sponsor: Hepa C
Sponsor class: OTHER
First posted: 2017-04-13
Enrollment: 130
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: Patients with HCV who are treated in real practice with Elbasvir/Grazoprevir

Brief summary: This is a multicentre, descriptive, observational and ambispective study carried out in patients who are treated with Elbasvir/Grazoprevir in hospitals that included their data in Hepa-C Registry (directed by the Spanish Association for the Study of the Liver and the Networked Biomedical Research Centre for Hepatic and Digestive Diseases).

Detailed description: This is a multicentre, descriptive, observational and ambispective study carried out in patients who are treated with Elbasvir/Grazoprevir in hospitals that included their data in Hepa-C Registry (directed by the Spanish Association for the Study of the Liver and the Networked Biomedical Research Centre for Hepatic and Digestive Diseases)

Eligibility criteria: Inclusion Criteria:

* Age: 18 years to 100 years (adult).
* Sexes: all
* Healthy volunteers: no
* Chronic hepatitis C (anti-HCV antibodies and detectable HCV-RNA).

Exclusion Criteria:

-

Primary outcomes:
measure: sustained virological response 12 weeks post-treatment (SVR12)
timeFrame: 12 weeks after the last dose of study drug
Secondary outcomes:
measure: virologic failure
timeFrame: Up to 8 weeks while on treatment
measure: SVR 12 and patients with mild fibrosis
timeFrame: Up to 12 weeks after last dose of study drug
measure: low baseline viral load and SVR12
timeFrame: Baseline and 12 weeks after the last dose of drug
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: HepaC
Study officials:
References:
citation: Hernandez-Conde M, Fernandez I, Perello C, Gallego A, Bonacci M, Pascasio JM, Romero-Gomez M, Llerena S, Fernandez-Rodriguez C, Castro Urda JL, Garcia Buey L, Carmona I, Morillas RM, Garcia ND, Gea F, Carrion JA, Castellote J, Moreno-Planas JM, Piqueras Alcol B, Molina E, Diago M, Montoliu S, de la Vega J, Menendez F, Sanchez Ruano JJ, Garcia-Samaniego J, Rosales-Zabal JM, Anton MD, Badia E, Souto-Rodriguez R, Salmeron FJ, Fernandez-Bermejo M, Figueruela B, Moreno-Palomares JJ, Calleja JL. Effectiveness and safety of elbasvir/grazoprevir therapy in patients with chronic HCV infection: Results from the Spanish HEPA-C real-world cohort. J Viral Hepat. 2019 Jan;26(1):55-64. doi: 10.1111/jvh.13008. Epub 2018 Oct 25.
Clinical trial NCT00582166: Ibritumomab Tiuxetan (Zevalin)+ Rituximab Maintenance
Official title: Ibritumomab Tiuxetan Plus Rituximab as Initial Therapy for Patients With High Tumor Burden, Indolent Histology Non-Hodgkin's Lymphoma
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Non-Hodgkin's Lymphoma
Keywords: Zevalin, High Tumor Burden Indolent Non-Hodgkin's Lymphoma, Ibritumomab Tiuxetan
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
Collaborators: name: Genentech, Inc.
First posted: 2007-12-28
Enrollment: 18
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: Subjects will receive the Ibritumomab Tiuxetan (Zevalin) therapeutic regimen; then rituximab consolidation and maintenance therapy every 3 months until disease progression

Detailed description: The objective of this study is to estimate the median progression-free survival for patients receiving this regimen, along with the rate of complete response at 6 months, toxicities associated with this regimen, and laboratory correlates. Subjects will receive the Ibritumomab Tiuxetan (Zevalin) therapeutic regimen; then rituximab consolidation and maintenance therapy every 3 months until disease progression.

Eligibility criteria: Inclusion Criteria:

* Patients with biopsy-proven non-hodgkins lymphoma of follicular grade 1, 2, or 3
* Meeting FLIPI criteria for intermediate or high risk.
* No prior chemotherapy, radiotherapy or immunotherapy for lymphoma;
* Patients may not have known HIV infection, and must not be Hepatitis B Surface Antigen positive.

Exclusion Criteria:

* May not be pregnant or breastfeeding, have documented CNS (Central Nervous System) disease, G-CSF (Granulocyte Colony Stimulating Facto) or GM-CSF (Granulocyte/Macrophage Colony Stimulating Factor) within 2 weeks prior

Primary outcomes:
measure: Median Progression Free Survival (PFS)
timeFrame: up to 5 years, 9.5 months, from first day on treatment to last follow up
Secondary outcomes:
measure: 24-month Progression Free Survival (PFS)
timeFrame: Up to 24 months
measure: Response Rates
timeFrame: Up to 5 years and 9.5 months
measure: Number of Participants Experiencing Toxicities, Measured by CTCAE v3.0
timeFrame: Up to 5 years and 9.5 months
measure: Overall Survival (OS)
timeFrame: At 12 months
Other outcomes:
Locations:
city: Madison
country: United States
facility: University Of Wisconsin
state: Wisconsin
Study officials:
affiliation: University of Wisconsin, Madison
name: Brad S Kahl, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01818466: Anterior Tibiotalar Arthrodesis With Blade Plate Fixation
Official title: Anterior Tibiotalar Arthrodesis With Blade Plate Fixation in Treatment of Post-traumatic Arthritis Secondary to Pilon Fracture
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Pilon Fracture
Arthritis
Lead sponsor: University of Utah
Sponsor class: OTHER
First posted: 2013-03-26
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who have previously undergone tibiotalar arthrodesis using an anterior approach with blade-plate fixation for tibiotalar arthritis secondary to injury to the articular surface of the distal tibia.

Brief summary: The aim of this study is to evaluate the clinical and radiographic outcomes of patients who have previously undergone tibiotalar arthrodesis using an anterior approach with blade-plate fixation for tibiotalar arthritis secondary to injury to the articular surface of the distal tibia.


Eligibility criteria: Inclusion Criteria:

* All patients whom have undergone anterior ankle arthrodesis with a blade plate construct, performed by a single surgeon, between January 2003 and July 2011 at the University of Utah or Primary Childrens Medical Center (PCMC) will be eligible for inclusion.

Exclusion Criteria:

* Any patient who is not 18 years of age or older will not be eligible for the study.

Primary outcomes:
measure: Outcome Questionnaires relating to the patients current condition
timeFrame: 1 Year after Surgery
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Orthopedic Surgery Operations
name: Thomas Higgins, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06348966: Predictors of Hospital Readmission for Chronic Obstructive Pulmonary Disease Patients
Official title: Predictors of Hospital Readmission for Chronic Obstructive Pulmonary Disease Patients,A Prospective Cohort Study
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Hospital Radmission for COPD Patients
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2024-04-05
Enrollment: 188
Sex: ALL
Minimum age (years): 25
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: this study is a prospective hospital-based cohort study

Brief summary: This study is aimed to determine the risk factors for hospital readmission within 6 months in COPD patients

Detailed description: This study is aimed to determine the risk factors for hospital readmission within 6 months in COPD patients and develop early warning model

Eligibility criteria: Inclusion Criteria:

* All COPD patients of both genders diagnosed by (GOLD) Guidelines (2024 Revision).
* Cooprative patients who accept to participate in the current study .

Exclusion Criteria:

* patients with cognitive impairment ,and unable to answer needed questions.
* patients with other lung diseases such as active pulmonary tuberculosis ,asthma ,bronchiactesis,and pulmonary embolism .
* patients with incomplete clinical data .
* Refused to participate in the current study .

Primary outcomes:
measure: assessment of potential predictors of readmission among COPD patients
timeFrame: 6 months
Secondary outcomes:
measure: development of early warning model for hospital readmission in COPD patients
timeFrame: within 6 months
Other outcomes:
Locations:
Study officials:
References:
citation: Alqahtani JS, Aldabayan YS, Aldhahir AM, Al Rajeh AM, Mandal S, Hurst JR. Predictors of 30- and 90-Day COPD Exacerbation Readmission: A Prospective Cohort Study. Int J Chron Obstruct Pulmon Dis. 2021 Oct 7;16:2769-2781. doi: 10.2147/COPD.S328030. eCollection 2021.
citation: Anbesse ZK, Mega TA, Tesfaye BT, Negera GZ. Early readmission and its predictors among patients treated for acute exacerbations of chronic obstructive respiratory disease in Ethiopia: A prospective cohort study. PLoS One. 2020 Oct 6;15(10):e0239665. doi: 10.1371/journal.pone.0239665. eCollection 2020.