louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05566249: A Study to Validate the Safety and Feasibility of ArtiSential in Colorectal Cancer Surgery Using Prospectively Constructed Multi-center Registry
Official title: A Study to Validate the Safety and Feasibility of ArtiSential in Colorectal Cancer Surgery Using Prospectively Constructed Multi-center Registry
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Rectal Cancer
Rectosigmoid Cancer
Rectosigmoid Junction Cancer
Keywords: laparoscopic surgery
minimally invasive surgery
robotic-assisted surgery
robotic surgery
Da Vinci system
ArtiSential
Articulating laparoscopic instrument
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
Collaborators: name: Asan Medical Center
name: Seoul St. Mary's Hospital
name: Chonnam National University Hospital
name: Severance Hospital
name: Seoul National University Bundang Hospital
name: Uijeongbu St. Mary Hospital
name: LivsMed
First posted: 2022-10-04
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The patients with rectal or rectosigmoid junction adenocarcinoma who will be planned to undergo elective low anterior resection with double stapled technique.

Brief summary: This study is to validate the safety and feasibility of ArtiSential (Articulating laparoscopic instrument) colorectal surgery and compare it with robotic surgery for patients with rectal cancer and rectosigmoid junction cancer.


Eligibility criteria: Inclusion Criteria:

* Age : 18 \~ 80 year old male or female
* Biopsy-proven adenocarcinoma
* Rectal cancer or Rectosigmoid junction cancer
* Primary cancer
* Non-metastatic cancer
* Planned (or elective) curative resection
* Low anterior resection with double-stapled technique

Exclusion Criteria:

* Preoperative systemic chemotherapy
* Distant metastasis at initial diagnosis
* Palliative surgery
* Emergent surgery
* Lynch syndrome or FAP-associated cancer

Primary outcomes:
measure: Surgical failure
timeFrame: 1 month
measure: Cost
timeFrame: 1 month
Secondary outcomes:
measure: Oncologic outcomes
timeFrame: 5-year
measure: Oncologic outcomes
timeFrame: 5-year
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
Study officials:
References:
Clinical trial NCT02850549: Preliminary Neck Classification Study
Official title: Implementation of a Neck Pain Classification System: A Preliminary Analysis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Neck Pain
Keywords: neck pain
cervical
classification
outcomes
physical therapy
Lead sponsor: St. Ambrose University
Sponsor class: OTHER
First posted: 2016-08-01
Enrollment: 17
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study was to assess if pain and function in patients with neck pain is less when physical therapists use a classification system.

Detailed description: The purpose of this study was to prospectively assess pain and function scores in patients with neck pain, with therapists specifically trained to implement a treatment based classification and matched interventions system. This study consisted of two phases to determine whether implementing a classification changed patient outcomes. In phase one, baseline data was obtained while physical therapists continued with their current neck pain evaluation and intervention approaches. The second phase involved educating the therapists in the neck classification system with the matched interventions. Pain and function outcomes were analyzed for 2 phases. The overall goal was to prospectively determine if the implementation of this classification system with matched interventions could enhance patient outcomes.

Eligibility criteria: Inclusion Criteria:

* Licensed physical therapists
* Treat patients with neck pain on a regular basis

Exclusion Criteria:

* Do not utilize interventions included in the study

Primary outcomes:
measure: Numeric Pain Rating (NPR)
timeFrame: up to 107 days
measure: Neck Disability Index (NDI)
timeFrame: up to 107 days
Secondary outcomes:
measure: Number of Visits
timeFrame: Measured from initial evaluation to time of discharge from care; up to 107 days.
measure: Duration of Care
timeFrame: Number of days of care, measured from initial evaluation to time of discharge from care; up to 107 days.
Other outcomes:
Locations:
city: Moline
country: United States
facility: Genesis Physical Therapy - King Plaza
state: Illinois
city: Silvis
country: United States
facility: Genesis Physical Therapy - Illini
state: Illinois
city: Bettendorf
country: United States
facility: Genesis Physical Therapy - Maplecrest
state: Iowa
city: Davenport
country: United States
facility: Genesis Physical Therapy - Lombard
state: Iowa
city: Davenport
country: United States
facility: Genesis Physical Therapy - 53rd St
state: Iowa
city: Davenport
country: United States
facility: Genesis Physical Therapy - Valley Fair
state: Iowa
city: Le Claire
country: United States
facility: Genesis Physical Therapy - Le Claire
state: Iowa
Study officials:
affiliation: St. Ambrose University
name: Kevin Farrell
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04383249: Routine Pathological Examination of Hernia Sac; Is it a Workload or Necessary?
Official title: Routine Pathological Examination of Hernia Sac; Is it a Workload or Necessary?
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pathology
Keywords: Hernia sac
inguinal hernia
incisional hernia
intestine
omentum
Lead sponsor: Dr. Ersin Arslan Education and Training Hospital
Sponsor class: OTHER_GOV
First posted: 2020-05-12
Enrollment: 437
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who have operated hernia and sent hernia sac for histopathological examination.

Brief summary: Routine microscopic examination of the hernia sac is controversial. While some centers do not recommend a routine microscopic examination in inguinal hernias in adult patients, they recommend them in abdominal wall hernias. The investigators aimed to discuss the pathology results and unexpected histopathological findings who underwent abdominal wall and inguinal hernia operation in the light of the literature.

Detailed description: The hernia is defined as the passage of an organ or tissue from one anatomical region to another. Hernia sacs are sent to the pathology department, although there is a difference between clinics. Routine microscopic examination of the hernia sac is controversial. While some centers do not recommend a routine microscopic examination in inguinal hernias in adult patients, they recommend them in abdominal wall hernias. Here, the investigators aimed to discuss the pathology results and unexpected histopathological findings who underwent abdominal wall and inguinal hernia operation in the light of the literature. Patients who have operated hernia and sent hernia sac for histopathological examination were retrospectively screened. Emergency and elective operated patients were included. Hernia repairs without pathology were excluded from the study. Patients' gender, age, operation notes, and pathology results were analyzed. Pathology results were analyzed in two groups as expected findings and unexpected findings. In our study, the probability of encountering an unexpected pathological result was found to be quite low in the pathological evaluation of the hernia sac. Although it may cause additional workload and cost, all hernia sacs should be sent to routine pathological examination. The investigators believe that making savings in these areas through further investigation after the decision of the pathologist.

Eligibility criteria: Inclusion Criteria:

* Emergency operated patients
* Elective operated patients

Exclusion Criteria:

* Hernia repairs without pathology examinations

Primary outcomes:
measure: unexpected finding
timeFrame: 2 or 3 week
Secondary outcomes:
Other outcomes:
Locations:
city: Gaziantep
country: Turkey
facility: Dr. Ersin Arslan Training and Resource Hospital
Study officials:
References:
Clinical trial NCT01986049: Transversus Abdominis Plane (TAP) Block for Post Caesarian Pain
Official title: Phase 3 Study Comparing Transversus Abdominis Plane Block After Caesarian Section Usin Bupivacaine 0.5% vs. Bupivacaine 0.25% vs. Placebo (Normal Saline).
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE3
Conditions: Obstetrical Complications From Sedation During Parturition
Lead sponsor: New York Presbyterian Brooklyn Methodist Hospital
Sponsor class: OTHER
First posted: 2013-11-18
Enrollment: 0
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Adding TAP block with Bupivacaine may decrease the use of PCA bolus use after caesarean section for pain relief.

Detailed description: Participants in the study will be randomized to TAP block with 0.5% or 0.25% bupivacaine or with placebo (normal saline).

The number of PCA bolus used within 24 hours post cesarean section will be compared between the groups.

Eligibility criteria: Inclusion Criteria:

Healthy pregnant (ASA II) patients presenting for planned Cesarean delivery at New York Methodist Hospital under combined spinal epidural anesthesia

Exclusion Criteria:

* They are unable or are unwilling to take part in the study
* They have a history of allergy to any of the medications to be used in the study
* They have a history of drug abuse or chronic pain or opioid use
* They weigh less than 60kg
* They have a multiple gestation, placental disease, preeclampsia other disease of pregnancy
* They have a contraindication to neuraxial anesthesia (i.e., bleeding problems, bacteremia, etc.)
* They are unable to understand instructions or questions related to the study
* ASA III or IV

Primary outcomes:
measure: Transversus Abdominis Plane (TAP) Block for Post Caesarean Pain
timeFrame: The first post operative 24 hours
Secondary outcomes:
measure: Decrease in the pain score as measured by Visual Analog Scale (VAS)
timeFrame: The first post operative 24 hours
Other outcomes:
Locations:
city: Brooklyn
country: United States
facility: New Yoyk Methodist Hospital
state: New York
Study officials:
affiliation: New York Methodist Hospital Hospital
name: Jonathan Weinberg, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT06034249: Mindfulness-Based VR for Family Caregivers of People With Dementia
Official title: The Effect of Mindfulness-Based VR on Depression, Sleep and Quality of Life Among Family Caregivers of People With Dementia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Caregivers of People With Dementia
Quality of Life
Keywords: Virtual Reality
Depression
Sleep Quality
Lead sponsor: Taipei Medical University
Sponsor class: OTHER
Collaborators: name: National Science and Technology Council
First posted: 2023-09-13
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A randomized controlled trial (RCT) design was used. Participants will be ask to attend the six-week course encompassed various mindfulness practices, including breathing observation, body scanning, mindful yoga, mindful walking, holistic meditation, and non-selective awareness practices. The control group will only be given the mindfulness-based audio files for six weeks.
Primary purpose: SUPPORTIVE_CARE

Brief summary: The goal of this clinical trial is to explore the effectiveness of mindfulness-based VR could enhance depression, sleep quality, and overall quality of life for family caregivers providing care for people with dementia.

Participants will be ask to attend the six-week course encompassed various mindfulness practices, including breathing observation, body scanning, mindful yoga, mindful walking, holistic meditation, and non-selective awareness practices. The control group will only be given the mindfulness-based audio files for six weeks.

Detailed description: The inclusion criteria for participants were as follows: (1) being a family caregiver responsible for caring for a family member diagnosed with dementia by a medical institution, (2) having the ability to communicate in Mandarin or Taiwanese, and (3) providing informed consent to participate in the study by signing the consent form. Individuals with visual and auditory impairments were excluded from the study.

Outcome measure: basic characteristics of participants; The Center for Epidemiologic Studies Depression Scale; Questionnaire of Taiwan's World Health Organization Quality of Life Brief Version.

Eligibility criteria: Inclusion Criteria:

1. being a family caregiver responsible for caring for a family member diagnosed with dementia by a medical institution,
2. having the ability to communicate in Mandarin or Taiwanese, and
3. providing informed consent to participate in the study by signing the consent form.

Exclusion Criteria:

Visual and auditory impairments were excluded from the study.

Primary outcomes:
measure: Depression
timeFrame: Baseline and six-week
Secondary outcomes:
measure: Sleep
timeFrame: Baseline and six-week
measure: QoL
timeFrame: Baseline and six-week
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Taipei Medical University
Study officials:
affiliation: Taipei Medical University
name: Megan F Liu, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01429649: Study of Ablation for the Pulmonary Focal Pure Ground Glass Opacity (pGGO)
Official title: A Prospective Study of Ablation of Pulmonary Focal Pure Ground Glass Opacity
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Pulmonary Lesions
Keywords: pure pulmonary ground glass opacity
Lead sponsor: Dongfang Hospital Beijing University of Chinese Medicine
Sponsor class: OTHER
First posted: 2011-09-07
Enrollment: 100
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: With the advent of CT screening for lung cancer, there is an increase in the detection of pulmonary lesions with focal pure ground-glass opacity (pGGO). The pure Ground-glass opacities can be caused by normal expiration, partial filling of air spaces, partial collapse of alveoli, interstitial thickening, inflammation, oedema, fibrosis, and lepidic proliferation of neoplasm. Precise details of the natural history of focal pure GGO are still largely unclear. A number of differential diagnoses are possible, including inflammatory disease, focal scar, atypical adenomatous hyperplasia (AAH), and adenocarcinoma in situ. Some of pGGOs remained stable over a considerable time. A long doubling time for pGGOs is already known. Therefore, the strategy of treatment for focal pure GGO lesions is still undecided. The major issue is whether or not the doctors should treat these patients at all or wait until the first sign of a solid lesion developes which may take many years.

The purpose of this study is to determine if the ablation therapy is safe and effective for the pulmonary pGGO.


Eligibility criteria: Inclusion Criteria:

* The lesion(s) treated with ablation must be =\< 2.0 cm in greatest dimension
* All patients are required to have been evaluated in a multi-disciplinary tumor conference to ensure that the lesion is suitable for Image-guided percutaneous ablation
* Platelet count ≥ 100 x 109/L
* International normalized ratio (INR) \< 1.5
* Absolute neutrophil count (ANC) ≥ 1.5 x 109/L
* A signed study specific consent form is required

Exclusion Criteria:

* Direct evidence of regional or distant metastases,or synchronous primary or prior malignancy in the past 5 years
* Unable to lie flat or has respiratory distress at rest
* Uncontrolled coagulopathy or bleeding disorders
* Evidence of active systemic, pulmonary, or pericardial infection
* Women who are pregnant or breastfeeding
* Patients with poor pulmonary function

Primary outcomes:
measure: The changing of the lesion
timeFrame: 3 years
Secondary outcomes:
measure: The side effect of the therapy.
timeFrame: 3 years
Other outcomes:
Locations:
city: Fuzhou
country: China
facility: Dongfang Hospital
state: Fujian
Study officials:
affiliation: Dongfang Hospital Beijing University of Chinese Medicine
name: Weisheng Chen, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03027349: Serum Calcium to Phosphorous Ratio (Ca/P) as a Simple, Inexpensive Screening Tool in the Diagnosis of Primary Hyperparathyroidism
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hyperparathyroidism
Lead sponsor: Azienda USL Modena
Sponsor class: OTHER
First posted: 2017-01-23
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with diagnosis of primary hyperparathyroidism

Brief summary: Background:

Primary hyperparathyroidism (PHPT) is often overlooked and underdiagnosed. At present the diagnosis of PHPT remains challenging and is based on serum calcium (Ca) and PTH.

As serum Ca and phosphorous (P) are inversely related in PHPT, the Ca/P ratio might be considered a good candidate tool in the diagnosis of PHPT.

AIM: The aim of this study is to investigate the diagnostic value of the Ca/P ratio in the diagnosis of PHPT.

Study design: Retrospective, observational, cross-sectional, case-control clinical trial will be carried out.

Biochemical measurements will include PTH, Vitamin D, serum Ca, P, albumin, and creatinine.


Eligibility criteria: Inclusion Criteria:

* elevated parathormone serum levels
* normal or elevated calcium serum levels

Exclusion Criteria:

* age younger than 18 years
* renal and liver failure and insufficiency
* active metabolic bone disease (such as Paget's disease of the bone, osteomalacia, rickets, etc)
* any type of cancer
* malnutrition, severe obesity (BMI \> 40 kg/m2) and malabsorption
* transplantation
* sarcoidosis
* endocrinological disorders such as hypercortisolism, diabetes insipidus, hyperthyroidism, pseudohypoparathyroidism
* familial hypocalciuric hypercalcemia
* hypophosphoremia sustained by genetic causes or secondary to other causes.

Primary outcomes:
measure: Calcium
timeFrame: Enrollment time
Secondary outcomes:
measure: Phosphorus
timeFrame: Enrollment time
measure: Parathormone
timeFrame: Enrollment time
measure: Creatinine
timeFrame: Enrollment time
measure: Albumine
timeFrame: Enrollment time
measure: Vitamin D
timeFrame: Enrollment time
Other outcomes:
Locations:
city: Modena
country: Italy
facility: Azienda USL of Modena
Study officials:
References:
Clinical trial NCT02217449: Virtual Chromoendoscopy for Distal Polyps
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Colorectal Polyps
Lead sponsor: University of Erlangen-Nürnberg Medical School
Sponsor class: OTHER
First posted: 2014-08-15
Enrollment: 230
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients undergoing screeining or surveillance colonoscopy

Brief summary: To assess the accuracy of predicting histology with virtual chromoendoscopy for distal colorectal polyps according to the ASGE PIVI statement.


Eligibility criteria: Inclusion Criteria:

* Written informed consent
* Screening or surveillance colonoscopy

Exclusion Criteria:

* history of inflammatory bowel disease
* poor bowel preparation
* colectomy
* anticoagulation
* polyposis syndrome

Primary outcomes:
measure: Effectivity of virtual chromoendoscopy
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Erlangen
country: Germany
facility: University Hospital Erlangen
Study officials:
References:
citation: Rath T, Tontini GE, Nagel A, Vieth M, Zopf S, Gunther C, Hoffman A, Neurath MF, Neumann H. High-definition endoscopy with digital chromoendoscopy for histologic prediction of distal colorectal polyps. BMC Gastroenterol. 2015 Oct 22;15:145. doi: 10.1186/s12876-015-0374-3.
Clinical trial NCT05280249: The Effects of Green Exercise Program Consisting of 12-week Aerobic and Resistance Exercises on Sleep Quality, Alexithymia, Anxiety and Depression in Elderly People
Official title: The Effects of Green Exercise Program Consisting of 12-week Aerobic and Resistance Exercises on Sleep Quality, Alexithymia, Anxiety and Depression in Elderly People
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Elderly
Exercise
Keywords: elderly
exercise
Affective Symptoms
anxiety
depression
Lead sponsor: Istanbul Medeniyet University
Sponsor class: OTHER
First posted: 2022-03-15
Enrollment: 40
Sex: ALL
Minimum age (years): 65
Maximum age (years): 85
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel Assignment Parallel Assignment Randomized
Primary purpose: TREATMENT

Brief summary: The aim of this study is to investigate the effects of combination of aerobic and resistance exercises in the green exercise concept on depression, anxiety, alexithymia and sleep quality of elderly individuals. Elderly individuals over the age of 65 will be included in the study. Two groups of 20 people each will take part in the study. One group will be given aerobic and resistance exercises for 12 weeks, 2 days a week in the green exercise concept, the other group will be the control group and will not be included in the exercise program. Participants will be evaluated twice, at the beginning of the study and at the end of 12 weeks.

Detailed description: Forty volunteer participants aged 65 years over will be included in the study. Participants will be randomly divided into two groups as experimental and control group. While experimental group will receive both aerobic and resistance exercises and control group will receive no exercise. Exercises will be held in an open and green area. Depression, anxiety, alexithymia and sleep quality of elderly individuals will be evaulated at the beginning of the treatment and at the end of the twelfth week. The exercise program will be done for 12 weeks, 2 days a week.

Eligibility criteria: Inclusion Criteria:

* people aged over 65 years
* Be fit to participate in exercise program after the first cardiac examination by the physician
* Having a score above 24 in the Minimental Test

Exclusion Criteria:

* Having neuromuscular disease
* Serious medical condition (for example, advanced malignancy or major neurological, psychiatric or endocrine disease, respiratory failure, etc.)
* Having an orthopedic disease that interferes with walking
* Having a score below 24 in the Minimental Test

Primary outcomes:
measure: Sleep quality
timeFrame: Change from baseline sleep quality at week 12.
measure: Anxiety
timeFrame: Change from baseline anxiety level at week 12.
measure: Depression
timeFrame: Change from baseline depression level at week 12.
measure: Alexithymia
timeFrame: Change from baseline alexithymia level at week 12.
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul Medeniyet University
Study officials:
References: