louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04359498: Retrospective Study of Surgical Complications in Patients With Defunctioning Stoma After Low Anterior Resection (LAR)
Official title: Retrospective Study of Surgical Complications in Patients With Defunctioning Stoma After Low Anterior Resection for Rectal Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rectal Cancer
Keywords: Low Anterior Resection
Lead sponsor: Safeheal
Sponsor class: INDUSTRY
Collaborators: name: Clinical Research Consultants, Inc.
First posted: 2020-04-24
Enrollment: 372
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients who underwent LAR for rectal cancer and are 12 months or longer postoperative from the LAR surgery will be reviewed for eligibility.

Brief summary: This study is being conducted to evaluate the incidence and type of surgical complications occurring in patients who have a defunctioning stoma after LARfor rectal cancer. The data from this retrospective study will be analyzed by the study Sponsor to aid in designing a prospective clinical trial for a new technology that offers a treatment alternative to standard of care defunctioning stoma in patients undergoing LAR for rectal cancer.


Eligibility criteria: Inclusion Criteria:

1. Adults, 18 years of age or older at the time the LAR surgery was performed.
2. Having an open or minimally invasive colorectal resection with diverting loop ileostomy surgical procedure performed between January 15, 2015 and January 15, 2019 for treatment of a known or suspected malignant condition.
3. Availability of medical records for a postoperative visit occurring 12 months (± 3 months) after the LAR surgery.

Exclusion Criteria:

1. Planned surgical procedure is a Hartmann's procedure (surgical resection of the rectosigmoid colon with closure of the anorectal stump and formation of an end colostomy).
2. Having a documented medical history of inflammatory bowel disease prior to the LAR surgery.
3. Having a concomitant major surgical procedure performed in combination with the LAR surgery (e.g., colorectal resection with hepatectomy).

Primary outcomes:
measure: Surgical complications
timeFrame: 12 Months
Secondary outcomes:
Other outcomes:
Locations:
city: Irvine
country: United States
facility: University of California, Irvine
state: California
city: Los Angeles
country: United States
facility: Keck School of Medicine of USC
state: California
city: Los Angeles
country: United States
facility: Cedars-Sinai Medical Center
state: California
city: Tampa
country: United States
facility: University of South Florida
state: Florida
city: Worcester
country: United States
facility: UMASS Memorial
state: Massachusetts
city: New Hyde Park
country: United States
facility: Northwell Health, Inc.
state: New York
city: New York
country: United States
facility: Icahn School of Medicine
state: New York
city: London
country: Canada
facility: Lawson Health Research Institute
state: Ontario
Study officials:
References:
Clinical trial NCT02812498: Teleconsultation in Type 1 Diabetes Mellitus
Official title: Teleconsultation in Type 1 Diabetes Mellitus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 1 Diabetes Mellitus
Keywords: teleconsultation
insulin therapy
HbA1c
Lead sponsor: Niguarda Hospital
Sponsor class: OTHER
First posted: 2016-06-24
Enrollment: 150
Sex: ALL
Minimum age (years): 5
Maximum age (years): 50
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The purpose of this study is to compare the effects on glycemic control of Teleconsultation versus standard visit in outpatient clinic for patients affected by type 1 diabetes mellitus.

Detailed description: The growing incidence of diabetes and the need to contain health care costs empower the necessity to identify new models to cope with regular periodic follow up of patients affected by diabetes mellitus. Telemedicine offers an acknowledged instrument to provide clinical health care at a distance, increasing patient compliance and the achievement of therapeutical goals. This study wants to verify the feasibility and the efficacy of teleconsultation in patients with type 1 diabetes mellitus. In particular by a randomized controlled approach the effects on glycemic control of patients followed by teleconsultation or traditionally in standard visit in the outpatient clinic. The patients in the teleconsultation group will arrange their bookings on a website (http://www.telediabete-fid.it/) In this website they could also access to web educational courses (mainly nutrition, insulin management, glucose monitoring auto-control) or to nutritional and psychological counselling.

Eligibility criteria: Inclusion Criteria:

* patients affected by type 1 diabetes mellitus, 5-50 years old under multi injection insulin therapy or under continuous subcutaneous insulin infusion
* with a feasible web access

Exclusion Criteria:

* without a feasible web access
* that need a periodic physical examination

Primary outcomes:
measure: glycosylated hemoglobin HbA1c
timeFrame: 12th month
Secondary outcomes:
measure: HbA1c glycosylated hemoglobin
timeFrame: 3rd to 6th to 9th month
measure: Patient satisfactory assessment by a questionnaire on their perception of advantages (diabetes management, comfort and convenience) and limits (technical problems, poor interaction with physicians) of the service
timeFrame: 12th month
measure: Cost analysis by patient estimation through a questionnaire of the overall cost and time saved thanks to the service
timeFrame: 12th month
Other outcomes:
Locations:
city: Legnano
country: Italy
facility: AO Ospedale Civile Legnano Legnano
city: Milano
country: Italy
facility: ASST Grande Ospedale Metropolitano Niguarda
Study officials:
References:
citation: Bertuzzi F, Stefani I, Rivolta B, Pintaudi B, Meneghini E, Luzi L, Mazzone A. Teleconsultation in type 1 diabetes mellitus (TELEDIABE). Acta Diabetol. 2018 Feb;55(2):185-192. doi: 10.1007/s00592-017-1084-9. Epub 2017 Dec 5.
Clinical trial NCT01988298: Nonsteroidal Antiinflammatory Drugs in Women With Postpartum Pre-eclampsia
Official title: Ibuprofen Versus Acetaminophen in Women With Severe Pre-eclampsia After Vaginal Delivery.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Hypertension
Lead sponsor: Complejo Hospitalario Dr. Arnulfo Arias Madrid
Sponsor class: OTHER
First posted: 2013-11-20
Enrollment: 114
Sex: FEMALE
Minimum age (years): 15
Maximum age (years): 44
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Hypertensive disorders of pregnancy are a major cause of maternal mortality and morbidity, especially in developing countries. Postpartum hypertension can be related to persistence of gestational hypertension, preeclampsia, or preexisting chronic hypertension, or it could develop de novo secondary to other causes. The available data in the medical literature have primarily focused on antenatal and peripartum management. There are few data regarding the evaluation in women who are diagnosis with postpartum hypertension. Some medications that cause vasoconstriction are often used for pain relief, in women having perineal lacerations, episiotomy, or cesarean delivery. Such women usually require large doses of nonsteroidal antiinflammatory drugs that are associated with vasoconstriction and sodium and water retention, this drugs can result in severe hypertension.

The purpose of this study is to evaluate maternal postpartum hypertension in women with severe preeclampsia treated with nonsteroidal antiinflammatory drugs or acetaminophen.

Detailed description: Our objective is evaluate Ibuprofen or acetaminophen used for pain during the postpartum period in women with severe pre-eclampsia. We include only women with vaginal delivery.

Eligibility criteria: Inclusion Criteria:

Vaginal delivery severe pre-eclampsia severe gestational hypertension aggregate pre-eclampsia

Exclusion Criteria:

sensitivities to ibuprofen cesarean delivery

Primary outcomes:
measure: level of postpartum hypertension
timeFrame: levels of hypertension up to 4 days post paertum
Secondary outcomes:
measure: complications
timeFrame: complications during the postpartum period (4 days)
Other outcomes:
measure: convulsions
timeFrame: maternal complicactions for 4 days postpartum
Locations:
city: Panamá
country: Panama
facility: Paulino Vigil-De Gracia
Study officials:
affiliation: Complejo Hospitalario Caja de Seguro social
name: Paulino Vigil-De Gracia, MD
role: STUDY_CHAIR
References:
Clinical trial NCT03452098: Post-Operative Rehabilitation of Knee Osteochondral Defect: A Case Series
Official title: Examination and Post-operative Rehabilitation of University Athletes With Osteochondral Lesions of the Knee: A Case Series Report
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Osteochondral Defect
Osteochondritis Dissecans
Lead sponsor: California State University, Northridge
Sponsor class: OTHER
First posted: 2018-03-02
Enrollment: 5
Sex: ALL
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 subjects were recruited from a population of student athletes at California State University, Northridge. These athletes were being treated by the Physical Therapy and/or Athletic Training Departments for Osteochondral Defect of the knee.

Brief summary: A case-series review was performed on five collegiate athletes with osteochondral lesions of the knee at California State University, Northridge (CSUN). All subjects received surgical intervention to treat the defect. The surgeries performed were either an Osteoarticular Transfer System (OATS) procedure and/or a Microfracturing procedure. Subjects were treated post-operatively by the CSUN team physical therapist and/or athletic trainers at CSUN. This paper seeks to provide information about osteochondral defects of the knee, the surgical interventions, and a protocol for post-operative treatment and rehabilitation of such injuries.


Eligibility criteria: Inclusion Criteria:

* Student athlete at CSUN
* Diagnosed with Osteochondral dissecans (OCD)
* Underwent surgical procedure to treat OCD
* Treated postoperatively by the team physical therapist and/or athletic trainers at CSUN.

Exclusion Criteria:

- No concurrent ligamentous injures to the knee during the time of subject participation in the study

Primary outcomes:
measure: Level of Function
timeFrame: Through study completion; an average of 6 months
Secondary outcomes:
measure: Pain
timeFrame: Monthly until the completion of the study; an average of 6 months
Other outcomes:
Locations:
city: Northridge
country: United States
facility: California State University, Northridge
state: California
Study officials:
affiliation: CSUN Physical Therapy Department
name: Aimie Kachingwe, PT, DPT, EdD, OCS, FAAOMPT
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01248598: The Prevelance Rate of Human Cytomegalovirus (HCMV), Epstein-Barr Virus (EBV) and Human Herpes Virus (HHV-6) in a Saliva of the Patient With Periodantitis
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cytomegalovirus
Epstein-Barr Virus Infections
Herpesvirus Infection
Lead sponsor: Rambam Health Care Campus
Sponsor class: OTHER
First posted: 2010-11-25
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient of the Department of Periodontology, School of Graduate Dentistry Rambam Health care campus

Brief summary: The purpose of this study is to study the prevalence of EBV, HCMV, HHV-6 in saliva and on the toothbrush patient with periodontitis.

Detailed description: Human cytomegalovirus (HCMV), Epstein-Barr virus (EBV) Human Herpes virus6 (HHV-6)

Eligibility criteria: Inclusion Criteria:

* Patient with peridontitis

Exclusion Criteria:

* Previous periodontal treatment in last 3 month
* Toothbrushing disability

Primary outcomes:
measure: The Prevelance Rate of the EBV, HCMV, HHV-6 in saliva
timeFrame: 1 year
Secondary outcomes:
measure: change outcomes EBV, HCMV, HHV-6 in saliva before and after toothbrushing
timeFrame: 1 year
Other outcomes:
Locations:
city: Haifa
country: Israel
facility: Department of Periodontology, School of Graduate Dentistry Rambam Health care campus
Study officials:
References:
Clinical trial NCT05125198: Translation, Cultural Adaptation and Validation of Urdu Version of VISA-A Questionnaire
Official title: Translation, Cultural Adaptation, and Validation of Urdu Version of Victorian Institute of Sports Assessment - Achilles (VISA-A) Questionnaire for Athletes With Achilles Tendinopathy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Achilles Tendinopathy
Keywords: Achilles tendinopathy
Validity
Reliability
Translation
VISA-A
Lead sponsor: University of Lahore
Sponsor class: OTHER
First posted: 2021-11-18
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: * Using the rule of Thumb: Minimum of 3 per items.
* Total items in the questionnaire=8
* As per rule of Thumb=8\*5=40
* n=40
* \*For better accuracy investigators will take sample size of 40 individuals with Achilles tendinopathy and 40 healthy ankles (Conventional group to assess known group validity).
* So n=80

Brief summary: This study is designed to translate and validate the VISA-A questionnaire to the Urdu language, to interpret its psychometric properties, and to determine the reliability of scores obtained from the population of Pakistan. The translated version of the gold standard tool will be used by the local population as well as Urdu-speaking immigrants across the globe to better understand and report the severity of their symptoms. Hence, to improve quality of life across cultures, there is a need of standard outcome measures in Urdu language.


Eligibility criteria: Inclusion Criteria:

* Individuals aged over 18 years and both genders.
* Athletic population with the diagnosis of unilateral mid-portion or insertional Achilles tendinopathy, paratendinosis, partial tendon rupture with or without retrocalcaneal bursitis.
* With positive Painful arc sign and Royal London Hospital Test.
* Healthy individuals.

Exclusion Criteria:

* Complete rupture of Achilles tendon,
* Pregnant women and those with any history of radicular pain or lower extremity injury
* Previous surgery

Primary outcomes:
measure: Change being assessed in interpretation of Severity of Achilles tendinopathy.among participants using translated version of VISA-A questionnaire.
timeFrame: 1 week
Secondary outcomes:
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: The University of Lahore
state: Punjab
Study officials:
References:
Clinical trial NCT04773977: Clinical Study of IBI362 in Healthy Chinese Male Subjects
Official title: Clinical Study to Evaluate the Pharmacokinetics and Safety of IBI362 Lyophilized Powder and IBI362 Liquid Formulation in Healthy Chinese Male Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Overweight/Obesity
Keywords: Pharmacokinetic
Safety
Lead sponsor: Innovent Biologics (Suzhou) Co. Ltd.
Sponsor class: INDUSTRY
First posted: 2021-02-26
Enrollment: 24
Sex: MALE
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a study to evaluate the pharmacokinetic characteristics and safety of IBI362 lyophilized powder and IBI362 liquid formulation in healthy Chinese male subjects.

Detailed description: Pharmacokinetic；Safety

Eligibility criteria: Inclusion Criteria:

1. 20 years old≤ Healthy males≤45 years old
2. 19 kilograms per meter squared (kg/m²)≤Body Mass Index≤26 kg/m²
3. Willing and agreeable to commit to the duration of the study and undergo study procedures as instructed by the clinic staff

Exclusion Criteria:

1. Subjects who have previously completed or discontinued from this study, or who have used IBI362.
2. Abnormal vital signs and physical examination during the screening period;
3. Having cardiovascular, respiratory, liver, kidney, digestive, endocrine, hematologic, neurological, or muscle degenerative diseases can significantly affect drug absorption, metabolism, or elimination, or participation in the study increases risk or interferes with data interpretation.
4. Have a previous or current mental illness.
5. A family history of medullary thyroid carcinoma or multiple endocrine tumor syndrome type 2.
6. There are other factors judged by the investigators that are not suitable for inclusion in this study.

Primary outcomes:
measure: Evaluate the PK parameters of IBI362 in healthy Chinese male subjects
timeFrame: From the first dose of study drug until 8 weeks
measure: Evaluate the PK parameters of IBI362 in healthy Chinese male subjects
timeFrame: From the first dose of study drug until 8 weeks
Secondary outcomes:
measure: Number of Participants With Adverse Events
timeFrame: From the first dose of study drug until 8 weeks
Other outcomes:
Locations:
city: Nanchang
country: China
facility: The Sceond Affiliated Hospital of Nanchang University
Study officials:
affiliation: The Sceond Affiliated Hospital of Nanchang University
name: Jian Li
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05360277: Maintenance Tislelizumab + Capecitabine to Treat Metastatic Colorectal Cancer
Official title: Maintenance Tislelizumab Combined With Capecitabine to Treat Metastatic Colorectal Cancer With No Evidence of Disease
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Metastatic Colorectal Cancer，NED
Keywords: Metastatic Colorectal Cancer，NED
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2022-05-04
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Surgery with integrated treatment for metastatic colorectal cancer (mCRC) has created a new clinical setting known as mCRC with no evidence of disease (NED). However, these patients have a high risk of developing persistent cancer. This study aimed to investigate the efficacy and safety of Tislelizumab combined with capecitabine as a maintenance treatment for patients with mCRC-NED.

Detailed description: This is a Phase 2, randomized, open-label, single-center study designed to compare the efficacy and safety of tislelizumab+ capecitabine versus best-supported care as a first-line maintenance treatment in participants with mCRC-NED.

Patients who underwent synchronously or staged removal of primary and metastatic lesions, achieving NED, and histologically confirmed colorectal adenocarcinoma were recruited in this trial. The primary endpoint was disease-free survival (DFS). Secondary endpoints included overall survival (OS) and adverse events. This study will provide novel data on the efficacy and safety profile of the combination of tislelizumab and capecitabine in patients with mCRC-NED.

Eligibility criteria: Inclusion Criteria:

1. Age ≥ 20 years, \< 80 years
2. Written informed consent
3. Histologically or cytologically confirmed CRC
4. Surgery with integrated treatment for metastatic colorectal cancer (mCRC) and achieved a statute of no evidence of disease (NED), as determined by a multidisciplinary tumor board.
5. cytoreduction surgery achieves CC0 (no visible residual tumor) if there is peritoneal metastasis
6. No previous chemotherapy
7. Synchronous or metachronous metastatic disease: maximum of two distant organs or regions involved
8. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1
9. Adequate hematologic and organ function

Exclusion Criteria:

1. Presence of any other active cancer
2. Presence of active infections requiring antibiotics
3. History of active autoimmune disease requiring systemic treatment

Primary outcomes:
measure: Disease-free survival
timeFrame: 36 months
Secondary outcomes:
measure: Overall survival
timeFrame: 60 months
measure: Adverse events
timeFrame: 60 months
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Gastrointestinal Hospital, Sun Yat-sen University
state: Guangdong
Study officials:
References:
Clinical trial NCT04242277: Wide-field Optical Coherence Tomography Imaging of Excised Breast Tissue.
Official title: A Prospective, Multi-center, Randomized, Double-arm Trial to Determine the Impact of the SELENE System on Positive Margin Rates in Breast Conservation Surgery.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer Female
Lead sponsor: Perimeter Medical Imaging
Sponsor class: INDUSTRY
Collaborators: name: Cancer Prevention Research Institute of Texas
First posted: 2020-01-27
Enrollment: 198
Sex: FEMALE
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: Consented patients meeting eligibility criteria, undergoing breast conservation surgery.

Brief summary: This is a single-arm, multi-center data collection study designed to collect WF-OCT imaging data of excised breast tissue margins with corresponding margin status from histopathology.

Detailed description: Data collected during this study will be used for product development by the study sponsor, Perimeter Medical Imaging.

Eligibility criteria: Inclusion Criteria:

* Female
* Age 18 years or older
* Invasive ductal breast carcinoma and ductal carcinoma in situ having undergone breast conservation surgery
* May include neo-adjuvant treated subjects (chemotherapeutic, endocrine therapy, or radiation)
* Ability to understand and the willingness to sign a written informed consent document

Exclusion Criteria:

* Metastatic cancer (Stage IV)
* Lobular carcinoma as primary diagnosis

Primary outcomes:
measure: WF-OCT image acquisition of excised lumpectomy tissue margins
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: Baylor College of Medicine
state: Texas
city: Houston
country: United States
facility: MD Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Savitri Krishnamurthy, MD
role: PRINCIPAL_INVESTIGATOR
References: