louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00261235: Trial of Supported Employment Versus USES Supported Employment
Official title: A Randomized Trial of Supported Employment Versus USES Enhanced Supported Employment in Veterans With Serious Mental Illness
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mental Disorders
Keywords: Rehabilitation, Vocational
Virtues
Employment, supported
veterans
Mentally Ill Persons
Lead sponsor: VA Connecticut Healthcare System
Sponsor class: FED
Collaborators: name: US Department of Veterans Affairs
First posted: 2005-12-02
Enrollment: 300
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 test the effectiveness of USES, a strengths-based enhancement to supported employment (SE), as compared to supported employment alone.

Detailed description: The objective of this study is to test the effectiveness of supported employment plus Using Strengths in Employment Services (USES), an enhancement to supported employment that seeks to identify and increase the use of personal strengths, as compared to supported employment alone, for veterans with severe mental illness and/or substance abuse disorders. We hypothesize that rates of competitive employment will be greater in the experimental group than the control group. We also expect that individuals in the USES group will have greater job tenure, and will show greater improvements in recovery measures such as empowerment, self-efficacy and self-esteem.

Eligibility criteria: Inclusion Criteria:

* Veteran
* Unemployed
* Referred by clinician to SE services
* Able to provide informed consent

Primary outcomes:
measure: job tenure (cumulative throughout course of study)
Secondary outcomes:
measure: empowerment
measure: self-efficacy
measure: self-esteem
Other outcomes:
Locations:
city: West Haven
country: United States
facility: West Haven VAMC
state: Connecticut
city: Syracuse
country: United States
facility: Syracuse VA Healthcare System
state: New York
Study officials:
affiliation: VA Northeast Program Evaluation Center
name: Sandra G. Resnick, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05068635: Evaluation of the Efficacy of Distal Gastrectomy for the Treatment of Gastric Cancer (a Case Series)
Official title: Evaluation of the Efficacy of Distal Gastrectomy for the Treatment of Gastric Cancer (a Case Series)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Gastric Cancer
Keywords: gastric cancer, gastric adenocarcinoma, total gastrectomy, subtotal gastrectomy, distal gastrectomy.
Lead sponsor: Centre Hospitalier Universitaire Ibn Rochd
Sponsor class: OTHER
First posted: 2021-10-06
Enrollment: 30
Sex: ALL
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study concerns patients who have been treated in our service for gastric cancer from fifteen years to unlimited age

Brief summary: Case series of a retrospective study of patients operated for distal adenocarcinoma of the stomach, either by total gastrectomy or distal gastrectomy at Ibn Rochd University Hospital in Casablanca, with the analysis of outcome of patients on a follow up periode of three years and eight months.

Detailed description: Thirty (30) patients were treated for gastric cancer and were included in this study. The average age was 64 years, the sex ratio 1.5. Twenty eight patients underwent a distal gastrectomy and 2 patients underwent total gastrectomy. The median number of lymph nodes resected was 6 following distal gastrectomy versus 26 after total gastrectomy. Resection margins were clean except for three patients who underwent a distal gastrectomy. Postoperative complicationsoccured in 05 patients. They were mainly infectious, anastomotic leakage. Two 2 cases of postoperative mortality (\<30 days) among patients with distal gastrectomy was noted. A progression to metastasis was found in 3 patients with subtotal gastrectomy, two of whom had insufficient lymph node clearance, compared to no cases of metastasis in patients with total gastrectomy.

Eligibility criteria: Inclusion Criteria: Patients bwith gastric cancer with histologic confirmation

Exclusion Criteria: Incomplete patients records

Primary outcomes:
measure: Number of patients who died for gastric cancer after distal gastrectomy
timeFrame: Fourty four months
measure: Number of patients who developped morbidity after subgastrectmy for gastric cancer
timeFrame: Forty for months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04244435: Neuroaxial Prophylaxis for CABG
Official title: Consequences of Using Thoracic Epidural Analgesia for Coronary Artery Bypass Grafting
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: EARLY_PHASE1
Conditions: Coronary Artery Occlusion
Keywords: coronary artery bypass grafting
prevention of complication
neuroaxial prophylaxis
thoracic epidural analgesia
Lead sponsor: Volgograd State Medical University
Sponsor class: OTHER
First posted: 2020-01-28
Enrollment: 300
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: PREVENTION

Brief summary: Investigators plan to study the effect of thoracic epidural analgesia on postoperative parameters (complication rate, duration of hospitalization, mortality, etc.) of coronary artery bypass grafting.

Detailed description: Investigators plan to conduct a comparative analysis of early postoperative complications of coronary artery bypass grafting with and without cardiopulmonary bypass in patients with independent risk factors for the development of postoperative complications (advanced age, diabetes mellitus, chronic kidney disease, obesity, chronic obstructive pulmonary disease) with various types of anesthesiology benefits (general anesthesia and thoracic epidural analgesia versus general anesthesia and opioids). Investigators predict a decrease in the risk of developing cardiac, respiratory, infectious and renal complications, a reduction in the duration of intensive care, inpatient treatment and mortality.

Eligibility criteria: Inclusion Criteria:

* coronary artery bypass grafting

Exclusion Criteria:

* Absolute contraindications for the use of thoracic epidural analgesia

Primary outcomes:
measure: hospital mortality
timeFrame: 1 year
measure: Hospitalization duration
timeFrame: 1 year
measure: Duration of treatment in the intensive care unit
timeFrame: up to 1 year
Secondary outcomes:
measure: Complications
timeFrame: 1 year
Other outcomes:
Locations:
city: Volgograd
country: Russian Federation
facility: Hospital №1 of Volgograd State Medical University
Study officials:
References:
Clinical trial NCT03062735: Efficacy of Inspiratory Muscle Training on Elite Swimmers
Official title: Protocol for a Randomized Controlled Trial Evaluating the Efficacy of Inspiratory Muscle Training on Swimming Performance, Airway Dysfunction and Perceived Breathlessness in Elite Swimmers
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Reactive Airways Dysfunction Syndrome (Disorder)
Muscle Weakness
Dyspnea
Lead sponsor: Universidade do Porto
Sponsor class: OTHER
First posted: 2017-02-23
Enrollment: 40
Sex: ALL
Minimum age (years): 14
Maximum age (years): 40
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: This study is a randomized controlled trial on the efficacy of inspiratory muscle training on swimming performance, airway dysfunction and perceived breathlessness in elite swimmers.

Detailed description: Only a few studies have assessed the impact of Inspiratory Muscle Training (IMT) on swim performance with unclear and inconsistent results. This study aims to evaluate the effect of a 12-week IMT program in swimming performance, airway dysfunction and perceived breathlessness among elite swimmers. Participants will be recruited from the elite competitive Futebol Clube do Porto swimming team. After consent, individuals will be randomly allocated into the IMT or Sham-IMT group. A pressure threshold device will be used to perform the inspiratory training. The IMT group will perform 30 inspiratory efforts, 5 times a week, twice a day, against a pressure threshold load equivalent to 50% of maximal inspiratory pressure (MIP). Sham-IMT group will follow a similar protocol, except for the inspiratory effort that will be made against 15% of MIP. Measures of lung function, swimming performance, airway dysfunction, inspiratory muscle strength and perceived breathlessness will be assessed at the beginning and then in 4 weeks intervals until the end of study period. All outcome measures will be assessed by an investigator who will be not involved in the intervention process. Data will be expressed as mean ± standard deviation (SD) and respective 95% confidence interval. The significance level will be 5% (p˂0.05).

Eligibility criteria: Inclusion Criteria:

* Healthy elite swimmers engaged in competitive training for a minimum period of three years;
* Individuals with no disability;
* Individuals aged between 14 and 40 years.

Exclusion Criteria:

* Individuals presenting co-morbidities or physical impairment that affects regular training;
* Smokers;
* Athletes already in a regular respiratory muscle training program
* Individuals with a predicted forced expiratory volume in the first second (FEV1) below 60%.

Primary outcomes:
measure: Swimming time trials performance
timeFrame: twelve weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Porto
country: Portugal
facility: Faculty of Medicine of Porto University
Study officials:
affiliation: Faculty of Medicine of the University of Porto
name: André Moreira, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02797535: GI Fluids Collection for an Ex-Vivo Development of Ingestible Capsule Devices With Real Time Biosensors
Official title: GI Fluids Collection for an Ex-Vivo Development of Ingestible Capsule Devices With Real Time Biosensors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Inflammatory Small Bowel Disease
Lead sponsor: Medtronic - MITG
Sponsor class: INDUSTRY
First posted: 2016-06-13
Enrollment: 66
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Up to 500 subjects undergoing standard endoscopy / pouchoscopy, or having ileostomy or colostomy bags or having an ileal pouch and who meet the eligibility criteria will be enrolled to this study during up to three years at up to 4 clinical sites. GI fluids samples will be collected from: (i) fluids suctioned during standard endoscopy procedures / pouchoscopy, (ii) from ileostomy/colostomy bags removed for bag replacement and (iii) from stool samples collected by patients after pouch surgery.

Detailed description: Up to 500 subjects undergoing standard endoscopy / pouchoscopy, or having ileostomy or colostomy bags or having an ileal pouch and who meet the eligibility criteria will be enrolled to this study during up to three years at up to 4 clinical sites. GI fluids samples will be collected from: (i) fluids suctioned during standard endoscopy procedures / pouchoscopy, (ii) from ileostomy/colostomy bags removed for bag replacement and (iii) from stool samples collected by patients after pouchsurgery.

The samples will be collected into sealed plastic containers, clearly labeled with "Biohazard" stickers and patient's code and be kept on ice for up to 30min and then freezed in -20deg to -80deg.

Characterization and quanification of small molecules- and protein biomarkers of GI diseases such as IBD will be performed.

Eligibility criteria: Inclusion Criteria:

* Subjects ages 18-75 years
* Subjects referred to endoscopic procedures gastroscopy, esophagogastroduodenoscopy (EGD), colonoscopy, single balloon or double balloon enteroscopy Or Subjects having ileostomy or colostomy bags Or Subjects having an ileal pouch
* Subjects agree to sign consent form

Exclusion Criteria:

* Patients has any medical condition that requires special handling of body fluids beyond routine infection control measures (i.e. standard surgical gloves)

Primary outcomes:
measure: Characterization and quantification of small molecules- and protein biomarkers of GI diseases will be performed. Examples of such biomarkers include - calprotectin, lactoferrin, albumin, hemoglobin, CEA, CA19-9, CA 72-4, LYVE-1, REG1A, TFF1 and ammonia.
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Ramat-Gan
country: Israel
facility: Sheba Medical Center
city: Tel-Aviv
country: Israel
facility: The Tel-Aviv Sourasky Medical Center
Study officials:
affiliation: Sheba Medical Center
name: Rami Eliakim, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00418535: Clinical Study of Chemoradiation Followed by VIPD in Nasal Natural Killer (NK)/T-cell Lymphoma
Official title: A Phase II Study of Concurrent Chemoradiation Followed by VIPD (Etoposide/Ifosfamide/Cisplatin/Dexamethasone) in Stage I, II Nasal NK/T-cell Lymphoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Lymphoma, T-Cell
Keywords: Lymphoma, NK/T-Cell
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
Collaborators: name: Korea University Anam Hospital
name: Asan Medical Center
name: Gyeongsang National University Hospital
First posted: 2007-01-05
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Nasal NK/T-cell lymphoma is a peculiar clinico-pathologic subtype of non-Hodgkin's lymphoma (NHL). Although most patients present with stage I/II, only 30-60% of the patients remain disease-free. The efficacy of the conventional anthracycline-based chemotherapy (cyclophosphamide, doxorubicin, vincristine, prednisone \[CHOPP\]) has been unsatisfactory.

The optimal treatment of localized NK/T-cell lymphoma has not been defined yet. The optimal dose, sequence, and multi-modality treatment with involved field radiotherapy still need to be refined. This trial is to evaluate the efficacy of concurrent chemoradiotherapy with cisplatin followed by VIPD (etoposide, ifosfamide, cisplatin, dexamethasone) in localized NK/T-cell lymphoma patients.


Eligibility criteria: Inclusion Criteria:

* Pathologically confirmed NK/T-cell lymphoma
* Localized (Ann Arbor stage I/II) disease
* At least one measurable lesion
* Age \> 18
* ECOG performance status 0 - 2
* Expected life span of at least 12 weeks
* Normal marrow function (hemoglobin ≥ 9.0 g/dL; absolute neutrophil count ≥ 1,500/mm3; platelet count ≥ 100,000/mm3)
* Normal liver function (total bilirubin \< 2x upper limit of normal \[ULN\], transaminase \< 3x ULN)
* Normal renal function (serum creatinine ≤ 1.5 mg/dL, creatinine clearance ≥ 50 mL/min)
* Written informed consent

Exclusion Criteria:

* Other malignancies except for treated non-melanoma skin cancers and cervical cancer in situ
* Serious medical illnesses (congestive heart failure, angina, respiratory failure, and renal failure)
* Acute or active infection requiring intravenous (IV) antibiotics
* Pregnant, lactating women
* Previous history of chemotherapy or radiotherapy
* Concomitant medication that may influence the study drugs
* Allergic reaction to study drugs
* Grade 2 or greater peripheral neuropathy

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
Study officials:
affiliation: Samsung Medical Center
name: Won Seog Kim, MD, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03208335: Recombinant Human Endostatin(Rh-endostatin) Combine With Radiotherapy in the Treatment of Hepatocellular Carcinoma(HCC)
Official title: A Phase II Trial Of Rh-Endostatin In Combination With Radiotherapy In The Treatment Of Hepatocellular Carcinoma
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Hepatocellular Carcinoma
Keywords: rh-endostatin
radiotherapy
Lead sponsor: Chinese PLA General Hospital
Sponsor class: OTHER
First posted: 2017-07-05
Enrollment: 61
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Hepatocellular carcinoma(HCC) is a high malignancy cancer which progress rapidly , and the rates of morbidity and mortality is very high in China. Radiotherapy as a effective treatment is commonly used in unresectable HCC patients. Preclinical models have shown that anti-angiogenesis medicine,such as rh-endostatin, can normalize the tumor vasculature to make it more efficient for oxygen delivery, which can enhance the radiosensitivity subsequently. This study is to evaluate the safety and efficacy of rh-endostatin combined with radiotherapy in the treatment of HCC.


Eligibility criteria: Inclusion Criteria:

* Histologically or cytologically confirmed hepatocellular carcinoma,or radiographic indicative HCC with AFP\>250ug/l
* Inoperable and untransplantable,Child-pugh score A or B
* PS score 0-1
* At least one measurable site(diameter \>20mm measured by CT or MRI,\>10mm measured by helical CT scan.
* No distant metastases
* Life expectancy longer than 3 months
* Willingness and ability to comply the study and signed informed consent.

Exclusion Criteria:

* Not comply the designed treatment or change to other treatment
* Miss follow-up visits or have incomplete follow-up data
* The efficacy will not be assessed if the Patient withdrawal the treatment due to severe adverse events(SAE),but SAE will be recorded.
* Disease progression
* Patients request to withdraw
* Patients with III hematologic or Ⅳ nonhematologic drug related toxicity ,or SAE

Primary outcomes:
measure: progress-free survival(PFS)
timeFrame: 18 months
Secondary outcomes:
measure: response rate(RR)
timeFrame: 18months
measure: clinical benefit rate(CBR)
timeFrame: 24months
measure: overall survival(OS)
timeFrame: 36 months
measure: adverse event(AE)
timeFrame: 36 months
measure: Quality of life (QOL)
timeFrame: 36months
Other outcomes:
Locations:
city: Beijing
country: China
facility: Chinese PLA Gereral Hospital
state: Beijing
Study officials:
affiliation: China PLA hospital
name: Yu Li, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02870335: Manual Therapy and Proprioceptive Neuromuscular Facilitation in Field Hockey Players.
Official title: Effectiveness of a Protocol Manual Therapy and Proprioceptive Neuromuscular Facilitation in Field Hockey Players.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hockey Players Whith Lower Back and Hamstring Pain
Keywords: low back
manual therapy
stretching
Lead sponsor: University of Valencia
Sponsor class: OTHER
First posted: 2016-08-17
Enrollment: 47
Sex: ALL
Minimum age (years): 16
Maximum age (years): 30
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Introduction: Field hockey is a contact sport. Semiflexion asymmetric position, along with other theories such as the weakness of the extensor muscles of the back or hamstring injury, can be causes or aggravating that suelan hockey players suffer back pain. Objectives: To observe the effectiveness of manual therapy techniques and post-isometric stretching (PNF) after three treatment sessions. In turn, know which of the two treatments have a greater benefit and longer. Methods: The population consists of grass hockey players and senior category aged between 16-30 years. They were randomly divided into two treatment groups. Group 1 corresponded to manual therapy techniques and group 2 to PNF stretching. The study duration for each subject was 5 sessions that included 3 treatment and 3 assessments. Each evaluation consisted of goniometry, balance test using the Sit and Reach, and Roland Morris questionnaire.


Eligibility criteria: Inclusion Criteria:

* field hockey players (HH) (senior category).
* between 16 and 30 years.
* suffered injuries and microtraumatic not prevent them from sports.

Exclusion Criteria:

* subjects with structural abnormalities of the spine.
* plantar alterations.
* other moderate or severe musculoskeletal previous injuries in the last 6 months and prevented them make sport normally.

Primary outcomes:
measure: Dynamic balance
timeFrame: 6 weeks
Secondary outcomes:
measure: Active Range of Moviment
timeFrame: 6 weeks
measure: Lumbar flexibility
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Valencia
country: Spain
facility: Gemma Espí López
Study officials:
References:
Clinical trial NCT06382935: Impact of Non-surgical Periodontal Treatment of miRNome
Official title: Effects of Minimally Non-surgical Periodontal Treatment Versus Quadrantwise Subgingival Instrumentations on miRNome in Gingival Tissues
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Periodontitis
Lead sponsor: University of Catania
Sponsor class: OTHER
First posted: 2024-04-24
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Non-surgical periodontal treatment Subgingival biofilm ultrasonic debridement with MINST or Q-SI
Primary purpose: TREATMENT

Brief summary: A double-blind randomized-controlled clinical trial is conducted in order to evaluate the impact of non-surgical periodontal treatment by means of minimally invasive approach MINST or Q-SI (quadrantwise) approach in subjects with periodontitis on miRNome in gingival crevicular fluid

Detailed description: A double-blind randomized-controlled clinical trial is conducted in order to evaluate the impact of non-surgical periodontal treatment in subjects with periodontitis.

60 patients: 30 with periodontitis and 30 healthy controls. All the patients are assessed for clinical, periodontal, blood following of minimally invasive approach MINST or Q-SI (quadrantwise).

Measurements are taken before and after initial periodontal treatment in the periodontal subjects.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of Periodontitis

Exclusion Criteria:

* Periodontal treatment
* Use of antibiotics, NSAIDs, and immunosuppressants during the last 6 months
* Pregnancy

Primary outcomes:
measure: Probing Pocket Depth
timeFrame: 6-months
Secondary outcomes:
Other outcomes:
Locations:
city: Catania
country: Italy
facility: AOU Policlinico G. Rodolico
Study officials:
affiliation: Università degli Studi di Catania
name: Gaetano Isola
role: PRINCIPAL_INVESTIGATOR
References: