louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02168582: Improvement After Physiotherapy for Low Back Pain: The Good Responders
Official title: Improvement After Physiotherapy for Low Back Pain: The Good Responders. An Observational Study in Primary Care
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Low Back Pain
Keywords: Physical Therapy Modalities
Prognosis
Patient Selection
Lead sponsor: Norwegian University of Science and Technology
Sponsor class: OTHER
Collaborators: name: Trondheim Kommune
First posted: 2014-06-20
Enrollment: 44
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Persons seeking primary care physiotherapy because of low back pain.

Brief summary: This is an observational study that aims to characterize individual response of patients getting physical therapy for chronic non-specific low back pain.

Participants will be classified based on a questionnaire and motor tests to investigate whether individual improvement after physical therapy may be predicted. These observations may help to decide which should be the preferred treatment offered.


Eligibility criteria: Inclusion Criteria:

* low back pain
* receiving primary care physiotherapy

Exclusion Criteria:

-

-

Primary outcomes:
measure: patient-reported disability
timeFrame: 1 year
Secondary outcomes:
measure: self-efficacy
timeFrame: 1 year
measure: global perceived effect
timeFrame: 1 year
measure: quality of life
timeFrame: 1 year
Other outcomes:
Locations:
city: Trondheim
country: Norway
facility: Department of Public Health and General Practice
Study officials:
affiliation: Norwegian University of Science and Technology
name: Siri Forsmo, prof md
role: STUDY_DIRECTOR
References:
Clinical trial NCT01617382: Register With Patients in Which Hyperthermic Intra-Peritoneal Chemotherapy (HIPEC) Was Performed
Official title: Register With Data From Patients With the Diagnosis of a Peritoneal Surface Malignancy, for Which Cytoreductive Surgery and Hyperthermic Intra-Peritoneal Chemotherapy (HIPEC) is Performed
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Peritoneal Carcinomatosis
Pseudomyxoma Peritonei
Peritoneal Mesothelioma
Keywords: HIPEC
Hyperthermic (heated) chemotherapy after debulking
Lead sponsor: Universitaire Ziekenhuizen KU Leuven
Sponsor class: OTHER
First posted: 2012-06-12
Enrollment: 125
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with peritoneal carcinomatosis of colorectal origin, patients with pseudomyxoma peritonei (type DPAM or PMCA) and patients with peritoneal mesothelioma who are planned to undergo cytoreductive surgery and HIPEC because of a peritoneal surface malignancy.

Brief summary: The purpose of this study is to register the follow-up data of patients who, because of a peritoneal surface malignancy, will undergo cytoreductive surgery and HIPEC.

Detailed description: To register the follow-up data of patients who, because of a peritoneal surface malignancy, will undergo cytoreductive surgery and HIPEC. In this surgical intervention, the abdominal cavity is macroscopically cleared of tumor, by removing all visible tumor nodules, and is subsequently rinsed with hyperthermic (heated) chemotherapy, aiming to destroy all residual invisible tumor cells that might have stayed behind after the debulking.

The eventual aim of this procedure is to improve the prognosis/survival of patients with malignancies localized on the peritoneal surface.

Eligibility criteria: Inclusion Criteria:

* Patients with peritoneal carcinomatosis of colorectal origin, patients with pseudomyxoma peritonei (type DPAM or PMCA) and patients with peritoneal mesothelioma who are planned to undergo cytoreductive surgery and HIPEC because of a peritoneal surface malignancy

Primary outcomes:
measure: To improve the prognosis/survival of patients with malignancies localized on the peritoneal surface.
timeFrame: Follow-up over a time period of at least 5 years
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 NCT05878782: the Impact of Occupational Therapy : a Multicenter Randomized Controlled Trial
Official title: Occupational Engagement in Alder Adults With Cancer - the Impact of Occupational Therapy (OCEAN-OT): a Multicenter Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Elderly Patient
Cancer
Quality of Life
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2023-05-26
Enrollment: 232
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A randomized, controlled, superiority trial in 3 parallel arms
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The purpose of this randomized controlled superiority trial is to evaluate the impact of occupational therapy assessment and intervention on the quality of life of elderly cancer patients.

Patients will be randomized into 3 parallel, multicenter arms with patient-reported outcome and blinded evaluator.

* Experimental group A will combine the assessment of occupational problems (MCRO) and an occupational therapy intervention.
* Experimental group B will have only the MCRO assessment because the occupational problems assessment alone (without intervention) could improve quality of life and occupational performance outcomes, according to the Nielsen, 2019 study
* Group C will have the usual cancer management care combining specific treatments and supportive care.

Detailed description: in order to limit the potential grading bias associated with the open-label design, the reassessment at 3 and 6 months will be performed by a different occupational therapist than the one who performed the initial assessment and occupational therapy intervention. For this reason, at least two occupational therapists per geographic area of the centers that include the patients will be included in the project.

Eligibility criteria: Inclusion Criteria:

* ≥ 70 years;
* Colorectal, breast, prostate or lung cancer;
* Between 1 and 3 months after the start of cancer treatment depending on the type of treatment (Surgery and/or systemic treatment and/or radiotherapy);
* For curative purposes;
* Affiliated to a social security scheme;
* Living at home;
* Agreeing to participate in the research and having given a free, informed and signed consent

Exclusion Criteria:

* person caring for a patient meeting the above criteria;
* Living with the patient;
* Agreeing to participate in the research and having given free, informed and signed consent

Primary outcomes:
measure: Quality of life (QLQ-C30 questionnaire)
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03646682: Pharmakokinetik of Caffeine in Epiretinal Membranes After Oral Intake: a Pilot Study
Official title: Pharmakokinetik of Caffeine in Epiretinal Membranes After Oral Intake: a Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Epiretinal Membrane
Lead sponsor: Vienna Institute for Research in Ocular Surgery
Sponsor class: OTHER
First posted: 2018-08-24
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: Caffeine concentrations in the vitreous Body and exzised epiretinal membranes are measured by gas-chromatography/mass spectrometry.

Detailed description: Caffeine concentrations in the vitreous Body and exzised epiretinal membranes are measured by gas-chromatography/mass spectrometry. One hour before surgery patients in the caffeine Group will receive 180mg of caffeine. in all patients vitrectomy with Membrane Peeling will be performed, due to epiretinal membranes

Eligibility criteria: Inclusion Criteria:

* epiretinale membrane

Exclusion Criteria:

* none

Primary outcomes:
measure: concentration of caffeine in vitreous probes and epiretinal membranes
timeFrame: one hour
Secondary outcomes:
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Vienna Institute for Research in Ocular Surgery (VIROS), Hanusch Hospital Vienna
Study officials:
affiliation: Vienna Institute for Research in Ocular Surgery
name: Oliver Findl, Professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01149382: Immune Response to Influenza Vaccine in Islet Cell Transplant Recipients
Official title: Humoral Immune Response To Influenza Vaccine In Islet Cell In Transplant Recipients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Transplant
Keywords: flu shot
islet cell transplant recipients
Lead sponsor: University of Alberta
Sponsor class: OTHER
First posted: 2010-06-23
Enrollment: 61
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult islet cell transplant recipients

Brief summary: Influenza virus is an important cause of morbidity in the transplant population and can lead to viral and bacterial pneumonia. Although the annual influenza vaccine is recommended for organ transplant patients, studies have shown that the standard inactivated influenza vaccine has poor immunogenicity in this population. The investigators plan to test the humoral response to vaccination and look at HLA upregulation

Detailed description: OBJECTIVE AND HYPOTHESIS

* To test the specific humoral response of the influenza vaccine after islet cell transplantation
* To test the production of HLA alloantibodies after vaccination.

Eligibility criteria: Inclusion Criteria:

* Adult islet cell transplant recipients
* Able to provide informed consent

Exclusion Criteria:

* Egg allergy
* Previous life-threatening reaction to influenza vaccine (ie Guillain Barre Syndrome)
* Febrile illness in the past two weeks
* Unable to provide informed consent

Primary outcomes:
measure: •Seroprotection rate
timeFrame: 3 months
Secondary outcomes:
measure: •Seroconversion rate
timeFrame: 3 months
Other outcomes:
Locations:
city: Edmonton
country: Canada
facility: University of Alberta Hospital
state: Alberta
Study officials:
affiliation: University of Alberta
name: Deepali Kumar, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04977882: Abdominal Drainage, Postoperative Antibiotico-prophylaxis and CME With D3 Lyphadenectomy Effect on Gastrointestinal Function in Laparoscopic Right Hemicolectomy With Intracorporeal Anastomosis for Right Colon Cancer
Official title: Abdominal Drainage, Postoperative Antibiotico-prophylaxis and CME With D3 Lyphadenectomy Effect on Gastrointestinal Function in Laparoscopic Right Hemicolectomy With Intracorporeal Anastomosis for Right Colon Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Colon Cancer
Keywords: intracorporeal anastomosis
right hemicoletomy
colon cancer
Lead sponsor: University of Rome Tor Vergata
Sponsor class: OTHER
First posted: 2021-07-27
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: Patients were initially randomized for postoperative management into three arms to receive prolonged antibiotic prophylaxis (ABX group), abdominal drain placement (DRAIN group) or neither (NONE group) (I level randomization). The same patients were further randomized for surgical technique in two arms to receive RRC (RRC group) or standard hemicolectomy with D2 dissection (STANDARD group) (II level of randomization).
Primary purpose: TREATMENT

Brief summary: Monocentric, two-level factorial, parallel-arm, pilot randomized clinical trial, conducted comparing patients undergoing laparoscopic right hemicolectomy with ICA for right colon cancer in a single unit of a teaching hospital: Minimally Invasive Surgery Unit, Department of Surgical Sciences, Policlinico Tor Vergata, Rome, Italy.


Eligibility criteria: Inclusion Criteria:

* Right colon cancer
* Intracorporeal anastomosis
* Laparoscopic surgery
* Elective surgery
* informed consent signed

Exclusion Criteria:

* below 18 years old
* IBD
* ASA IV
* T4b
* Metastatic disease
* Preoperative steroids
* Conversion to open surgery
* Emergency surgery
* concomitant major operation
* preoperative infective status
* benign disease

Primary outcomes:
measure: Tolerance to solid diet
timeFrame: 30 days postoperatively
Secondary outcomes:
measure: White blood cell
timeFrame: 30 days postoperatively
measure: Procalcitonine
timeFrame: 30 days postoperatively
measure: Days of hospitalization
timeFrame: 90 days postoperatively
measure: Readmission rate
timeFrame: 90 days postoperatively
measure: Mortality rate
timeFrame: 90 days postoperatively
measure: Surgical site infection rate
timeFrame: 30 days postoperatively
measure: Anastomotic leak rate
timeFrame: 30 days postoperatively
measure: Tolerance to liquid diet
timeFrame: 30 days postoperatively
measure: Time to first flatus
timeFrame: 30 days postoperatively
measure: Time to first evacuation
timeFrame: 30 days postoperatively
measure: need of abdomen CTscan rate
timeFrame: 30 days postoperatively
measure: C-Reactive Proteine
timeFrame: 30 days postoperatively
Other outcomes:
Locations:
city: Rome
country: Italy
facility: University of Rome Tor Vergata
Study officials:
References:
Clinical trial NCT05254782: Using ctDNA to Detect Minimal Residual Disease After Lung Cancer Resection
Official title: From Liquid Biopsy to Cure: Using ctDNA Detection of Minimal Residual Disease to Identify Patients for Curative Therapy After Lung Cancer Resection (ctDNALung-Detect)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Non Small Cell Lung Cancer
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
Collaborators: name: Ontario Institute for Cancer Research
name: The Princess Margaret Cancer Foundation
First posted: 2022-02-24
Enrollment: 360
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Early stage (T1-T4 (T3,T4 multifocal) N0M0) non-small cell lung cancer, with planned complete surgical resection.

Brief summary: ctDNALung-Detect is an investigator-initiated single arm, multi-institution study designed to assess the ctDNA detection rate and its association with Relapse Free Survival (RFS) in operable stage T1-T4 (T3,T4 multifocal) N0M0 non-small cell lung cancer (NSCLC) patients.


Eligibility criteria: Inclusion Criteria:

1. Age ≥ 18 years;
2. Ability to provide written informed consent;
3. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;
4. T1-T4 (T3,T4 multifocal) N0M0 NSCLC who are planned for complete surgical resection;
5. Tumour size must be at least 1 cm (unidimensional) and have at least some solid component on imaging;
6. Surgical tumour formalin-fixed, paraffin-embedded (FFPE) specimens for ctDNA studies are required.

Exclusion Criteria:

1. Prior radiation, surgery or chemotherapy for the current diagnosis of NSCLC is not permitted.
2. Incomplete surgical resection. Participants who had pre-operative ctDNA samples taken but subsequently do not have a complete surgical resection would not qualify for post-operative ctDNA testing.
3. Concurrent enrolment in a therapeutic study using drug or radiation therapy. Enrolment in observational, diagnostic or studies of novel surgical techniques will be allowed.
4. Concurrent active malignancy or other invasive malignancy within previous 2 years. Non-invasive malignancies (i.e., cervical carcinoma in situ, in situ prostate cancer, non-melanomatous carcinoma of the skin, ductal carcinoma in situ of the breast that has been surgically cured) are excluded from this definition.
5. Pregnancy.

Primary outcomes:
measure: Rate of ctDNA Detection
timeFrame: Up to 24 Months
measure: Relapse Free Survival
timeFrame: Up to 36 Months
Secondary outcomes:
measure: Overall Survival
timeFrame: Up to 36 Months
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Michael Garron Hospital
state: Ontario
city: Toronto
country: Canada
facility: St. Joseph's Health Centre
state: Ontario
city: Toronto
country: Canada
facility: University Health Network
state: Ontario
Study officials:
References:
Clinical trial NCT02371382: Multicentre Prospective Study to Evaluate Long-term Clinical Outcomes of the Sirius Cemented Femoral Stem
Official title: Multicentre Prospective Study to Evaluate Long-term Clinical Outcomes of the Sirius Cemented Femoral Stem
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Arthroplasty, Replacement, Hip
Lead sponsor: Zimmer Biomet
Sponsor class: INDUSTRY
First posted: 2015-02-25
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: minimum age: 18 maximum age: gender: both

Brief summary: The purpose of this multicentre, prospective study is:

* Document the Clinical and Radiographic performance of the stem at 3 months, 1 year, 3 years, 5 years, 7 and 10 years.
* Report Safety and Survivorship up to 10 years F/up.

Detailed description: This study intends to evaluate the safety and performance of the Sirus cemented hip stem in terms of function improvement postoperatively, stability and fixation of femoral stem and survivorship.

Eligibility criteria: Inclusion Criteria:

Selection of subjects for this evaluation should be in accordance with the indications of Sirus stem:

1. Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis.
2. Rheumatoid arthritis
3. Correction of functional deformity
4. Treatment of non-union, femoral neck fracture and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques.
5. Revision procedures where other treatments or devices have failed. The Sirius Femoral Hip Stem is intended for cemented use only and may be used in partial and total hip arthroplasties

Exclusion Criteria:

* Absolute contraindications include:

infection, sepsis, osteomyelitis

Additional contraindications include:

* Uncooperative patient or patient with neurologic disorders who are incapable of following directions,
* Osteoporosis,
* Metabolic disorders which may impair bone formation
* Osteomalacia
* Distant foci of infections which may spread to the implant site
* Rapid joint destruction, marked bone loss or bone resorption apparent on roentgenogram
* Vascular insufficiency, muscular atrophy or neuromuscular disease.

Primary outcomes:
measure: Harris Hip Score
timeFrame: 1 year
Secondary outcomes:
measure: Oxford Hip score
timeFrame: 10 years
Other outcomes:
Locations:
city: Vejle
country: Denmark
facility: Sygehus Vejle
city: Penarth
country: United Kingdom
facility: University Hospital of Wales, Llandough Hospital
state: Wales
Study officials:
affiliation: University Hospital of Wales
name: Alun John
role: PRINCIPAL_INVESTIGATOR
affiliation: Lillebaelt Hospital Vejle, Denmark
name: Per Kjærsgaard-Andersen, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00780182: Comparative Bioavailability and Effect of Food on CMX001 in Healthy Volunteers
Official title: An Open-Label, Randomized, 3-Way Crossover, Single-Dose Study in Healthy Volunteers Comparing the Bioavailability of CMX001 (HDP-Cidofovir Conjugate) Delivered as a Tablet Formulation vs a Solution Formulation and the Effect of Food on CMX001 Bioavailability
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Bioavailability
Lead sponsor: Chimerix
Sponsor class: INDUSTRY
Collaborators: name: National Institutes of Health (NIH)
First posted: 2008-10-27
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare the bioavailability of CMX001 when administered as a tablet vs a solution and to determine the effect of a high-fat meal on CMX001 bioavailability.


Eligibility criteria: Inclusion Criteria:

* Healthy males and non-childbearing females 18-55 years old

Exclusion Criteria:

* Use of an investigational drug and/or treatment within 30 days prior to enrollment.
* Positive HIV, Hepatitis B or Hepatitis C test result
* Tobacco user
* History of GI disease or disorder
* History of positive fecal occult blood test (FOBT)
* Body Mass Index (BMI) \> 30 or \< 18, or body weight \< 50 kg
* Prior abdominal or pelvic surgery

Primary outcomes:
measure: AUC and Cmax of CMX001 and cidofovir
timeFrame: Each of 3 doses
Secondary outcomes:
measure: Clinical and laboratory endpoints and adverse events
timeFrame: Throughout the study
Other outcomes:
Locations:
city: Rtp
country: United States
facility: AAI Pharma
state: North Carolina
Study officials:
affiliation: AAIPharma
name: Evin H Sides, III, MD
role: PRINCIPAL_INVESTIGATOR
References: