louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00754078: A Phase II Study to Assess Acute Toxicity and Quality of Life of Patients With Carcinoma of the Anal Canal Receiving Chemotherapy and Radiation Using Helical Tomotherapy
Official title: A Phase II Study to Assess Acute Toxicity and Quality of Life of Patients With Carcinoma of the Anal Canal Receiving Chemotherapy and Radiation Using Helical Tomotherapy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Anal Canal Cancer
Keywords: tomotherapy
Lead sponsor: AHS Cancer Control Alberta
Sponsor class: OTHER
First posted: 2008-09-17
Enrollment: 58
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The hypothesis is that helical tomotherapy could minimize radiation related toxicity by avoiding or limiting doses to structures such as small bowel, external genitalia, skin, bladder, rectum, and femoral neck and head.

Detailed description: This is a phase II study using tomotherapy for radiation treatment delivery along with concurrent 5-FU/mitomycin C for the treatment of T2-T4 cancer of the anal canal. They hypothesis is that helical tomotherapy could minimize radiation related toxicity by avoiding or limiting doses to structures such as small bowel, external genitalia, skin, bladder, rectum, and femoral neck and head. This is expected to limit or reduce treatment related toxicity and hence prevent or reduce treatment breaks. This may result in delivery of radical treatment with better local control and treatment outcome than using the current radiation treatment technique at our center.

Eligibility criteria: Inclusion Criteria:

* Patient should have histologically proven primary squamous carcinoma or its variant
* No history of prior malignancy.
* Patients must be free of metastatic disease out of pelvis at the time of diagnosis
* Patients must be at least 18 years of age
* Performance status 0, 1 or 2 ECOG
* T stage 2-4, Any N, stage MO
* Patient should be eligible for concomitant chemotherapy
* Informed written consent required to participate

Exclusion Criteria:

* Prior radiation to pelvis
* Pregnant or lactating
* prior surgical treatment for anal cancer other than biopsy
* prior surgical or chemotherapy treatment for anal cancer
* T1 tumours (2cm) or evidence of distant mets
* comorbid medical conditions precluding radical treatment at the discretion of oncologist

Primary outcomes:
measure: Acute Toxicity and Quality of LIfe
timeFrame: 3 months
Secondary outcomes:
measure: colostomy-free survival and/or overall survival
timeFrame: 3 and 5 years
measure: Local Recurrence
timeFrame: 3 and 5 years
Other outcomes:
Locations:
city: Edmonton
country: Canada
facility: Cross Cancer Institute
state: Alberta
Study officials:
affiliation: AHS Cancer Control Alberta
name: Kurian J Joseph, MD, FRCPC
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02197078: Active Surveillance Research Program for the Assessment of the Safety and the Effectiveness of Linagliptin
Official title: Active Surveillance Research Program for the Assessment of the Safety and the Effectiveness of Linagliptin
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes Mellitus, Type 2
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
Collaborators: name: Eli Lilly and Company
First posted: 2014-07-22
Enrollment: 189426
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: T2DM patients aged 18 or older, initiating antidiabetic treatment after at least 6 months of continuous enrollment

Brief summary: This protocol is for a series of comparative effectiveness and safety analyses within periodically updated cohorts of patients initiating linagliptin, other DPP-4 inhibitors, and other oral hypoglycemic medications, followed longitudinally for the occurrence of a variety of health outcomes. The primary analysis will be conducted among patients without prior within-class medication use.


Eligibility criteria: Inclusion criteria:

* A dispensing of an oral hypoglycemic medication
* A diagnosis of type 2 diabetes mellitus (T2DM)

Exclusion criteria:

* less than 18 years old
* missing or ambiguous age or sex information
* at least one diagnosis of type 1 diabetes mellitus
* less than 6 months enrolment in the database preceding the date of the first dispensing
* secondary diabetes
* history of cancer
* end-stage renal disease (ESRD)
* HIV
* organ transplant

Primary outcomes:
measure: Number of Participants With Major Adverse Cardiovascular Event
timeFrame: Up to 5 years and 7 months
measure: Number of Participants With Coronary Revascularization
timeFrame: Up to 5 years and 7 month
measure: Number of Participants With Acute Coronary Syndrome
timeFrame: Up to 5 years and 7 months
measure: Number of Participants With Stroke
timeFrame: Up to 5 years and 7 months
Secondary outcomes:
measure: Number of Participants With Heart Failure Hospitalization
timeFrame: Up to 5 years and 7 months
measure: Number of Participants With Incident End Stage Renal Disease
timeFrame: Up to 5 years and 7 months
measure: Number of Participants With Acute Renal Failure
timeFrame: Up to 5 years and 7 months
measure: Number of Participants With Acute Renal Failure Requiring Dialysis
timeFrame: Up to 5 years and 7 months
Other outcomes:
Locations:
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
Study officials:
affiliation: Boehringer Ingelheim
name: Boehringer Ingelheim
role: STUDY_CHAIR
References:
Clinical trial NCT04589871: Taping Technique With Supervised Exercises Protocol on Pain and Functional Status in Individuals With Arthritis
Official title: Efficacy of Taping Technique in Addition to the Supervised Exercises Protocol on Pain and Functional Status in Individuals With Patello-femoral Arthritis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Patellofemoral Osteoarthritis
Keywords: Patellofemoral osteoarthritis
Therapeutic exercises
VAS
WOMAC
Taping
Lead sponsor: King Saud University
Sponsor class: OTHER
First posted: 2020-10-19
Enrollment: 40
Sex: ALL
Minimum age (years): 40
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Two-arm parallel groups randomized control trial
Primary purpose: TREATMENT

Brief summary: Osteoarthritis (OA) is claimed to be a global burden and a key health issue that affects the large weight-bearing joints of the lower extremity such as the knee and hip joints. The study was aimed to find out the efficacy of the tapping technique in addition to the supervised exercise protocol on pain intensity and functional status of an individual with patella-femoral arthritis.

Detailed description: The study was based on a controlled pretest-posttest experimental group design. After initial screening, forty individuals (mean age 55years, ranged 40-60years) with patello-femoral arthritis randomly (n=20each) assigned into two group A and B. Group A received taping technique in addition to the supervised exercises protocol while group B received supervised exercises protocol only. Both the groups received their specified treatment 5 consecutive days in a week for 4weeks. Data collected for the variables (VAS and WOMAC) at day1 pre-intervention (baseline) and at day 28th post-intervention. The t-test used for within and between group analysis with keeping the p\<0.05.

Eligibility criteria: Inclusion Criteria:

* The individuals with unilateral patella-femoral osteoarthritis
* Aged between 40-60years;
* Pain more than 3cm on VAS;
* Crepitus on movement,
* Showing osteophytes on standing skyline view of radiograph (Kallgren/Lawrence grade ≥2),
* found positive for the special tests (coordination test for the muscle vastus medialis, apprehension test for patellar, Clarke's test, and Waldron's test with phase I and II)

Exclusion Criteria:

* The individuals with involvement of tibio-femoral joint;
* Presence of patella alta/baja;
* History of rheumatoid arthritis/traumatic knee, knee surgeries within six months
* On steroid injection, neurological deficit, fragile skin around the knee, allergic to tape;
* Poor cooperation

Primary outcomes:
measure: Pain Intensity
timeFrame: 4-weeks
measure: Functional status
timeFrame: 4-weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Riyadh
country: Saudi Arabia
facility: Rehabilitation Research Chair
Study officials:
affiliation: Rehabilitation Research Chair, CAMS, King Saud University, Riyadh, Saudi Arabia
name: AMIR IQBAL, MPT-Ortho
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03772171: Estimate for Dietary Intakes and Hemodialysis Patients
Official title: Evaluation of the Use of an Analog Scale to Estimate Dietary Intakes, EPA, for Hemodialysis Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Nutrition Disorders
Dialysis
Chronic Renal Failure
Dietetician
Lead sponsor: University Hospital, Caen
Sponsor class: OTHER
First posted: 2018-12-11
Enrollment: 100
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 chronic end stage renal failure treated by hemodialysis in hemodialysis center

Brief summary: The aim of this clinical research is to evaluate the relevance of using the EPA slide to estimate dietary intakes in dialysis patients. The obtained results will be compared with the reference technique validated by the HAS: food intake over 3 days.

The aim is also to improve the global management of dialysis patients and improve their quality of life. The aim is to evaluate a quick and easy-to-use tool whose use has been demonstrated in hospitals but for which no study has been carried out in an ambulatory hospitalization context.


Eligibility criteria: Inclusion Criteria:

* Patient must be able to understand and voluntarily sign an informed consent form
* Patient with chronic end stage renal failure treated with hemodialysis.
* Patient with age \>= 18 years

Exclusion Criteria:

* Patient treated by peritoneal dialysis
* Patient with age \< 18 years
* Patient with intellectual limitations that may limit the comprehension of questionnaires
* Patient with communication disorders or verbal comprehension
* Patient not French speaking
* Patient with enteral nutrition
* Patient having been hospitalized for less than 2 months

Primary outcomes:
measure: Evaluation of the validity of the EPA to estimate, on an outpatient basis, dietary intakes in dialysis patients
timeFrame: 10 days
Secondary outcomes:
Other outcomes:
Locations:
city: Caen
country: France
facility: Néphrology Caen University Hospital
Study officials:
References:
Clinical trial NCT02560571: Pre-operative Studies for Prediction of Lymph Nodes Involvement in Endometrial Cancer Patients
Official title: Preoperative Evaluation of Endometrial Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Endometrial Cancer
Lead sponsor: Meir Medical Center
Sponsor class: OTHER
First posted: 2015-09-25
Enrollment: 200
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The study evaluates pre-operative prediction of the risk for lymph nodes involvement in endometrial cancer patients. Patients will undergo ultrasound exam (bi and three dimensional) and biomarker test - Ca 125, in addition to routine physical and laboratory exams, before surgery.

The sonographic evaluation will include endometrial characteristics and myometrial invasion, pelvic findings and enlarged lymph nodes.


Eligibility criteria: Inclusion Criteria:

* Endometrial cancer patients
* Surgical candidates

Exclusion Criteria:

* Fertility preservation therapy
* Contraindication for surgery
* Stage 2 and higher

Primary outcomes:
measure: number of participants with positive nodes
timeFrame: 4 weeks after surgery (4-6 weeks from enrollment)
Secondary outcomes:
Other outcomes:
Locations:
city: Kefar Saba
country: Israel
facility: Meir medical center
Study officials:
References:
Clinical trial NCT02807571: Office Based Hand Surgery Using WALANT (Wide Awake Local Anesthesia No Tourniquet): Outcomes and Cost Savings Analysis
Official title: Office Based Hand Surgery Using WALANT (Wide Awake Local Anesthesia No Tourniquet): Outcomes and Cost Savings Analysis
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Surgery
Keywords: Hand
Lead sponsor: Spectrum Health Hospitals
Sponsor class: OTHER
First posted: 2016-06-21
Enrollment: 0
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: Consecutive patients seen for office based procedures that otherwise would be performed in the outpatient surgical setting from January 1, 2015 to December 4, 2015.

Brief summary: This study is aimed at determining if office based surgery is an effective way of cutting health care cost while maintaining patient safety and satisfaction.

Detailed description: The study is a retrospective chart review with prospective patient satisfaction and functional outcome surveys.

Patients that have had office based procedures that otherwise could be performed in the outpatient surgical setting from January 1, 2015 to December 4, 2015 will be contacted for study enrollment. Patient satisfaction and functional outcome surveys will be administered to those patients that consent to the research study.

The data to be collected will include but is not limited to: age gender limb dominance, complications and co-morbidities.

Eligibility criteria: Inclusion Criteria:

* Patients seen for office based procedures that otherwise would be performed in the outpatient surgical setting from January 1, 2015 to December 4, 2015

Exclusion Criteria:

* K-wire hardware removal
* Closed reductions
* Patients receiving antibiotics at the time of the procedure

Primary outcomes:
measure: Complication Rates
timeFrame: 2 months
Secondary outcomes:
measure: Cost savings
timeFrame: 2 months
Other outcomes:
Locations:
city: Grand Rapids
country: United States
facility: Spectrum Health
state: Michigan
Study officials:
affiliation: Spectrum Health Hospitals
name: Peter Jebson, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04314271: The Observational Study of Cardiac and Pulmonary Ultrasound and Evaluation of Treatment of Severe Patients With Novel Coronavirus Pneumonia
Official title: The Observational Study of Cardiac and Pulmonary Ultrasound and Evaluation of Treatment of Severe Patients With Novel Coronavirus Pneumonia
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Novel Coronavirus Pneumonia
Lead sponsor: Xiangya Hospital of Central South University
Sponsor class: OTHER
First posted: 2020-03-19
Enrollment: 80
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: Adult (Age ≥ 18 years) patients with novel coronavirus pneumonia

Brief summary: Complete the examination of cardio-pulmonary ultrasound in accordance with the a-ccue process of patients with novel coronavirus bedside. To summarize and analyze the characteristics of cardiopulmonary ultrasound in patients with novel coronavirus pneumonia, and assess the relationship between pulmonary ultrasound imaging score and National Early Warning Score(NEWS) and prognosis. Auto line B is a method which is based on artificial intelligence is used to calculate the lungs ultrasonic B line numbers reviewing the status of patients with lung, and also evaluate patients' lungs using the traditional artificial semi-quantitative method, to evaluate those two kinds of evaluation methods for the evaluation of patients with lung condition effects are consistent or not, and verify consistency of ultrasonic evaluation method and the way of CT evaluation.


Eligibility criteria: Inclusion Criteria:

1. age \>18 years old
2. identify the patients infected with novel coronavirus pneumonia;
3. the patient completed CT examination;
4. sign the informed consent.

Exclusion Criteria:

1. age \< 18;
2. those who cannot complete cardiopulmonary ultrasound according to the a-ccue process;
3. the patient or his guardian requests to withdraw from the researcher;

Primary outcomes:
measure: characteristics of cardiopulmonary ultrasound
timeFrame: 30 mins
Secondary outcomes:
measure: assess the relationship between pulmonary ultrasound imaging score and National Early Warning Score(NEWS) and prognosis.
timeFrame: 2-3weeks
Other outcomes:
measure: evaluate two kinds of evaluation methods for the evaluation of patients with lung condition effects are consistent or not, and verify consistency of ultrasonic evaluation method and the way of CT evaluation.
timeFrame: 3 hours
Locations:
city: Changsha
country: China
facility: Xiangya Hospital, Central South University
state: Hunan
Study officials:
affiliation: Xiangya Hospital
name: Zhang Li Na, MD
role: STUDY_CHAIR
References:
Clinical trial NCT00939471: Safety and Efficacy of Balloon Sinuplasty in Pediatric Sinusitis
Official title: Clinical Evaluation of Confirm the Safety and Efficacy of Balloon Sinuplasty Devices in the Treatment of Pediatric Sinusitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Sinusitis
Lead sponsor: Integra LifeSciences Corporation
Sponsor class: INDUSTRY
Collaborators: name: Acclarent
First posted: 2009-07-15
Enrollment: 44
Sex: ALL
Minimum age (years): 2
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: A non-randomized, multi-center, prospective, clinical study intended to evaluate the safety and efficacy of balloon sinuplasty devices in pediatric patients with longstanding sinusitis following failed medical management.


Eligibility criteria: Inclusion Criteria:

1. Age \> 2 and \< 18 years
2. Both male and female patients eligible
3. Planned surgical intervention (i.e. endoscopic sinus surgery, adenoidectomy, sinus irrigation for obtaining a culture) recommended by PI, consented to by patient's legal guardian)
4. Longstanding sinusitis: \>3 mo symptoms OR 6 episodes/yr AND failed 2 courses antibiotics followed by positive CT scan

Exclusion Criteria:

1. Extensive previous sinonasal surgery in target ostia
2. Cystic fibrosis
3. Extensive sinonasal osteoneogenesis
4. Sinonasal tumors or obstructive lesions
5. History of facial trauma that distorts sinus anatomy and precludes access to the sinus ostium
6. Ciliary dysfunction
7. For female patients of childbearing age: the patient is either pregnant or lactating

Primary outcomes:
measure: Safety: Device-related Adverse Events During Balloon Dilation Through 12 Months
timeFrame: 12 months
measure: Effectiveness: Change in Sinus Symptom Scores (SN-5)
timeFrame: 12 months
measure: Effectiveness: Change in Sinus Symptom Scores (SNOT-20)
timeFrame: 12 months
Secondary outcomes:
measure: Device Success: Ability to Access/Dilate Sinus Ostia
timeFrame: 12 months
measure: Effectiveness: Medication Thru 1 yr
timeFrame: 12 months
measure: Effectiveness of Dilation/Measured by Post-op Interventions
timeFrame: 12 months
measure: Days Out of School During the 12 Months of Follow-up
timeFrame: 12 months
measure: Revision Rate
timeFrame: at 1 year
Other outcomes:
Locations:
city: Morgantown
country: United States
facility: West Virginia University
state: West Virginia
Study officials:
affiliation: West Virginia University
name: Hassan Ramadan, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06239571: Resilient Families
Official title: Resilient Families: A Dyadic Resiliency Intervention for Parents of Babies in the NICU
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Parents
Keywords: Neonatal Intensive Care Unit
Parental mental health
Parental relationships
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2024-02-02
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The goal is to develop, refine, and test the feasibility and acceptability of a dyadic, resiliency intervention ("Resilient Families;" R-FAM) that aims to reduce emotional distress and improve relationships among parents in the Neonatal Intensive Care Unit (NICU). To achieve this goal, my aims are three-fold: (1) develop R-FAM using stakeholder input from interviews with parent dyads and focus groups with NICU staff; (2) optimize R-FAM through an open pilot with pre/post assessments and exit interviews; and (3) test R-FAM for feasibility and acceptability through a randomized clinical trial of R-FAM compared with a minimally enhanced usual control (MEUC).


Eligibility criteria: Inclusion Criteria:

* Adult parent/legal guardian (and/or their partner) of a baby admitted to the NICU within past week (age ≥ 18)
* Currently in an intimate relationship and will live with baby after NICU discharge
* At least one dyad member is emotionally distressed (HADS \>7 on depression or anxiety subscale)
* English fluency/literacy
* Ability and willingness to participate via live video

Exclusion Criteria:

* Baby is expected to pass away (as determined by medical team)
* Current, untreated psychosis or substance dependence/abuse
* Current self-report of suicidal ideation

Primary outcomes:
measure: Depression
timeFrame: Baseline to end of intervention (6 weeks)
measure: Anxiety
timeFrame: Baseline to end of intervention (6 weeks)
measure: Posttraumatic Stress
timeFrame: Baseline to end of intervention (6 weeks)
Secondary outcomes:
measure: Couple relationship functioning
timeFrame: Baseline to end of intervention (6 weeks)
measure: Family Impact
timeFrame: Baseline to end of intervention (6 weeks)
Other outcomes:
Locations:
city: Boston
country: United States
facility: Mass General Brigham
state: Massachusetts
Study officials:
References: