louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04518033: Measuring Droplets in Children
Official title: Measuring Droplets in Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Droplet Spread
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: Harvard School of Public Health (HSPH)
First posted: 2020-08-19
Enrollment: 23
Sex: ALL
Minimum age (years): 3
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: This study will measure the size and quantity of respiratory particle production in children under a variety of conditions, including face coverings/masks and various common activities.


Eligibility criteria: Inclusion Criteria:

- Age 3 to 17 years

Exclusion Criteria:

* Chronic neuromuscular conditions that affect respiration
* Tracheostomy tube
* Unable to wear a face mask

Primary outcomes:
measure: Respiratory particle production
timeFrame: 2 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Peter P Moschovis, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03818633: Elastic Abdominal Binder Following Gynecologic Cancer Surgery
Official title: Effect of Elastic Abdominal Binder on Pain and Functional Recovery Following Gynecologic Cancer Surgery: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gynecologic Cancer
Lead sponsor: Chiang Mai University
Sponsor class: OTHER
First posted: 2019-01-28
Enrollment: 109
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Surgery is the primary treatment for gynecologic malignancies. The surgical approach provides opportunities for removal of the affected organs and complete assessment of extent of cancer spread. However, the procedures are often associated with significant morbidity. This is especially true with open laparotomy, the most frequently employed approach in developing countries. Delayed functional recovery influenced by pain and immobilization are important contributing factors for increased morbidity. Elastic abdominal binder, a wide elastic belt that is wore around the patient's abdomen to support surgical incision after surgery, has been employed by clinicians for pain relief, wound complications prevention, improved pulmonary function, and stabilization. Benefits of the abdominal binder use in this patient population have not been properly examined.

The aim of this study is to examine the effect of postoperative elastic abdominal binder use on recovery by comparing pain scores and mobility function (through the 6-minute walk test \[6MWT\]) in postoperative gynecologic cancer patients who use versus do not use the elastic abdominal binder to support incisional site.


Eligibility criteria: Inclusion Criteria:

* Women, diagnosed with gynecologic malignancies (carcinoma of the cervix, endometrium, and ovary), undergoing open abdominal surgery

Exclusion Criteria:

* Intraoperative accidental injury to urinary or gastrointestinal organs
* Postoperative admission to intensive care unit (ICU)
* Postoperative intraperitoneal drain placement
* Unable to understand and follow oral/written instructions
* Severe neuromuscular or circulatory disorders

Primary outcomes:
measure: Daily average postoperative pain scores
timeFrame: An average of pain scores at 8:00 am and 4:00 pm, up to 7 days postoperation
measure: Six-minute walk test score change from baseline
timeFrame: One day before operation and postoperative day 3
Secondary outcomes:
measure: Quality of life: EuroQol Group's ED-5D-5L questionnaire
timeFrame: In the morning of postoperative day 3
measure: Rate of postoperative complications
timeFrame: In the morning, up to 7 days postoperation
Other outcomes:
Locations:
city: Chiang Mai
country: Thailand
facility: Kittipat Charoenkwan
Study officials:
affiliation: Chiang Mai University
name: Kittipat Charoenkwan, MD, MSc
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03628833: Incontinence Management System ICU Field Evaluation
Official title: Hill-Rom Incontinence Management System ICU Field Evaluation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Urinary Incontinence
Fecal Incontinence
Lead sponsor: Hill-Rom
Sponsor class: INDUSTRY
First posted: 2018-08-14
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The objective of this Field Evaluation is to assess usage and satisfaction associated with the Hill-Rom Incontinence Management System.


Eligibility criteria: Inclusion Criteria:

* Patients with urinary, fecal, or dual incontinence who are ≥ 18 years old
* The patient, or the patient's legal authorized representative (LAR), is willing and able to provide written informed consent

Exclusion Criteria:

- Patients that are considered to be near death or require palliative care

Primary outcomes:
measure: Staff satisfaction surveys on product performance
timeFrame: Through study completion, an average of 4 months
Secondary outcomes:
measure: Patient exposure time following an incontinence event
timeFrame: Through study completion, an average of 4 months
Other outcomes:
Locations:
city: Lexington
country: United States
facility: Saint Joseph Hospital
state: Kentucky
Study officials:
References:
Clinical trial NCT02356133: The Relationship Among rSO2, MAP, et al by Near-Infrared Spectroscopy in Endovascular Neurosurgery
Official title: The Relationship Among rSO2, MAP,CAM Value, Vital Organ Disfunction and the Outcome of Patients After Operation by Near-Infrared Spectroscopy in Endovascular Neurosurgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Near-Infrared Spectroscopy in Endovascular Neurosurgery
Keywords: Near-Infrared Spectroscopy
Lead sponsor: China International Neuroscience Institution
Sponsor class: OTHER
First posted: 2015-02-05
Enrollment: 43
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Scheduled to undergoing Endovascular Neurosurgery

Brief summary: record,describe and discuss the relationship among rSO2, MAP,CAM value, vital organ disfunction and the outcome of patients after operation by Near-Infrared Spectroscopy in Endovascular Neurosurgery

Detailed description: record,describe and discuss the relationship among rSO2, MAP,CAM value, vital organ disfunction and the outcome of patients after operation using Near-Infrared Spectroscopy in Endovascular Neurosurgery meanwhile detect the Brain oxygen supply and function monitoring using noninvasive Near-Infrared Spectroscopy in Endovascular Neurosurgery.

Eligibility criteria: Inclusion Criteria:

* American Society of Anesthesiology (ASA) class I\~Ⅲ, ranging in age from 18 to 80 years

Exclusion Criteria:

* ASA\>Ⅳ
* Non-cooperators
* Morbid obesity (BMI\>35kg/m2)
* Preoperative hyperresponsiveness airway and gastro-esophageal reflux
* The existence of the state or a diagnosis of dementia, delirium, depression, cognitive dysfunction before surgery were also excluded

Primary outcomes:
measure: there is relationship between rSO2 and MAP during neurosurgery
timeFrame: 2 month
measure: there is relatinship between rSO2 and CAM values
timeFrame: 2 month
measure: vital organ disfunction related to rSO2 and bad outcome of the patients
timeFrame: 3 month
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Wang X, Feng K, Liu H, Liu Y, Ye M, Zhao G, Wang T. Regional cerebral oxygen saturation and postoperative delirium in endovascular surgery: a prospective cohort study. Trials. 2019 Aug 14;20(1):504. doi: 10.1186/s13063-019-3586-y.
Clinical trial NCT02932033: Trial Comparing Tack Versus Histoacryl Mesh Fixation After Endoscopic TEP(Total Extraperitoneal) Repair for Bilateral Inguinal Hernia
Official title: Randomized Control Trial Comparing Tack Versus Histoacryl Mesh Fixation After Endoscopic TEP (Total Extraperitoneal) Repair for Groin Hernias
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Inguinal Hernia
Lead sponsor: Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation
Sponsor class: OTHER
First posted: 2016-10-13
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: This prospective randomized trial is performed to analyze the post-operative pain (acute and chronic) after endoscopic TEP repair after bilateral inguinal hernia repair.

Detailed description: consecutive patients with bilateral inguinal hernias will be recruited for TEP repair. Mesh fixation methods spiral tacks glue is randomly assigned to one side to the groin and Histoacryl synthetic glue to the other side. Patients will be followed up regularly for up to 6 months by an independent clinical nurse was blinded to the mesh fixation assignment. The patients are also blinded to the the mesh fixation assignment. The post operative pain score, peri-operative complication, and recurrences will be documented.

Eligibility criteria: Inclusion Criteria:

* Patients present with clinical bilateral inguinal hernias And feasible for general anesthesia

Exclusion Criteria:

* Patient preference for either fixation technique, refusal to participate, previous major lower abdominal surgery, concomitant surgical procedures other than hernia repair, and history of allergy to Histoacryl.

Primary outcomes:
measure: acute post-operative pain with VAS
timeFrame: 6 hours after OP
Secondary outcomes:
measure: Chronic pain VAS pain scale
timeFrame: 6 months after OP
measure: Questionnaire of complications
timeFrame: 6 months after OP
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Buddhist Tzu Chi General Hospital, Taipei branch
Study officials:
References:
Clinical trial NCT04105933: Culturally Sensitive Cognitive Behavioural Therapy for the Survivors of Intimate Partner Violence (IPV)
Official title: The Effects of Culturally Sensitive Cognitive Behavioural Therapy on Women Experienced Intimate Partner Violence
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mental Abuse of Adult
Emotional Abuse
Domestic Violence
Lead sponsor: NMP Medical Research Institute
Sponsor class: OTHER
Collaborators: name: Warwick Research Services
First posted: 2019-09-26
Enrollment: 92
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Women experience negative psychological outcomes long after the violent relationship has ended. Women suffer constant trauma and psychological distress being in emotional and mentally abusive relationship. Present study developed Culturally sensitive cognitive-behaviour therapy (CBT) to fit the client's cultural identity, context, and preferences.


Eligibility criteria: Inclusion Criteria:

* Women victim of intimate partner violence
* Still in relationship with abuser
* Willing to attend 16-weeks sessions

Exclusion Criteria:

* In need of clinical supervision or treatment
* Severe mental disorders
* Cognitive disorders
* Refused to give written consent

Primary outcomes:
measure: Psychological symptoms
timeFrame: Change from baseline to 16 weeks
Secondary outcomes:
measure: Self esteem
timeFrame: Change from baseline to 16 weeks
measure: Forgiveness
timeFrame: Change from baseline to 16 weeks
Other outcomes:
Locations:
city: Bundi
country: India
facility: Gyansaneejvani
state: Rajasthan
city: Jaipur
country: India
facility: NMP Medical Research Institute
state: Rajasthan
Study officials:
affiliation: Warwick Research Services
name: Neha Sharma, PhD
role: STUDY_DIRECTOR
affiliation: NMP Medical Research Institute, India
name: Rachana Khandelwal, PhD
role: STUDY_CHAIR
affiliation: Patan Girls College, India
name: Anurag Sharma, MPhil
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03942133: Tow Techniques of Adductor Canal Block for Analgesia After Total Knee Replacement
Official title: Ultrasound-guided Continuous Adductor Canal Block for Analgesia After Total Knee Replacement: Comparison of Block at the Entrance and Middle of the Canal
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Total Knee Arthroplasty
Analgesia
Nerve Block
Keywords: adductor canal block
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
First posted: 2019-05-08
Enrollment: 62
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: SUPPORTIVE_CARE

Brief summary: This study compares the tow technique of continues adductor canal block for total knee replacement surgery. Half participants will receive catheterization at the entrance of the adductor canal, while the other half will receive catheterization at the middle point of the adductor canal.


Eligibility criteria: Inclusion Criteria:

* 18-80 years
* Knee-arthroscopy
* Written consent
* ASA I-III
* BMI 19-35

Exclusion Criteria:

* Unable to communicate with the investigators (e.g., a language barrier or a neuropsychiatric disorder).
* coagulopathy or on anticoagulant medication
* Allergic reactions toward drugs used in the trial
* History of substance abuse
* Infection at injection site
* Can not be mobilised to 5 meters of walk pre-surgery

Primary outcomes:
measure: cumulative sulfentanil consumption at 24 hours after surgery
timeFrame: 24 hours after surgery
Secondary outcomes:
measure: the strength of quadriceps femoris
timeFrame: 0,2,4,8,24,48 hours postoperatively
measure: The pain scores at rest determined by the numeric rating scale (NRS, 0-10)
timeFrame: at 0,2,4,8,24,48 hours postoperatively
measure: The pain scores on adduction of the keen determined by the numeric rating scale (NRS, 0-10)
timeFrame: at 0,2,4,8,24,48 hours postoperatively
measure: incidence of postoperative nausea and vomiting (PONV)
timeFrame: within 48 hours after surgery
measure: Patient satisfaction with anesthesia
timeFrame: within 5th day after surgery
measure: complications
timeFrame: within 3days after surgery
measure: cumulative sulfentanil consumption at other time points after surgery
timeFrame: 2,4,8,48 hours postoperatively
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking Union Medical College Hospital
Study officials:
References:
citation: Fei Y, Cui X, Chen S, Peng H, Feng B, Qian W, Lin J, Weng X, Huang Y. Continuous block at the proximal end of the adductor canal provides better analgesia compared to that at the middle of the canal after total knee arthroplasty: a randomized, double-blind, controlled trial. BMC Anesthesiol. 2020 Oct 9;20(1):260. doi: 10.1186/s12871-020-01165-w.
Clinical trial NCT06215287: Survey to Assess Physicians' Knowledge of Exjade Posology and Biological Monitoring Recommendations as Described in the Educational Materials
Official title: Survey to Assess Physicians' Knowledge of Exjade Posology and Biological Monitoring Recommendations as Described in the Educational Materials
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Iron Overload
Keywords: Physician Survey,
PAS,
Deferasirox
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2024-01-22
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Exjade (deferasirox) prescribers

Brief summary: The objective of this survey is to assess the knowledge of HCPs in relation to the recommended posology and biological monitoring for Exjade, based on the current locally valid Exjade educational materials (including the physician's reference checklist)


Eligibility criteria: Inclusion Criteria:

Physicians will be required to meet all of the following inclusion criteria:

* Must provide consent for participation
* Must spend ≥50% of time in direct patient care
* Have treated patients with transfusional iron overload or non-transfusion-dependent thalassemia with chelation therapy during the last 12 months.
* Have prescribed Exjade and/or generic deferasirox within the last 12 months.

Exclusion Criteria:

Physicians meeting the following criterion will not be eligible to take the survey:

• Currently employed by a pharmaceutical company, health care company, market research company, advertising agency, or government agency involved in pharmaceutical research or marketing.

Primary outcomes:
measure: Mean percentage of correct responses related to knowledge of posology and biological monitoring recommendations as described in the Exjade EU Summary of Product Characteristics (SmPC)
timeFrame: Through study completion, an average of 6 months.
Secondary outcomes:
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References:
Clinical trial NCT00271687: A Pilot Study of Exercise in Patients With Docetaxel-Based Chemotherapy for Hormone Refractory Prostate Cancer
Official title: A Pilot Study of Exercise in Patients With Docetaxel-Based Chemotherapy for Hormone Refractory Prostate Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Prostatic Neoplasms
Neoplasm Metastasis
Palliative Care
Keywords: exercise
exercise therapy
activities of daily living
quality of life
Lead sponsor: AHS Cancer Control Alberta
Sponsor class: OTHER
Collaborators: name: Cross Cancer Institute
First posted: 2006-01-04
Enrollment: 30
Sex: MALE
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: This study aims to provide preliminary data on the feasibility and outcomes of a 12 week exercise program on the quality of life of men with hormone refractory prostate cancer receiving docetaxel-based chemotherapy.


Eligibility criteria: Inclusion Criteria:

* diagnosis of prostate cancer
* receiving docetaxel-based chemotherapy at the CCI
* age 18 years or over
* approval of oncologist
* informed written consent

Exclusion Criteria:

* life expectancy less than 6 months
* Karnofsky performance score less than 70
* contraindications for exercise (e.g. uncontrolled cardiac, respiratory, hypertensive or psychiatric disorder)
* unable to understand, read, write and speak English
* unable or unwilling to attend supervised exercise sessions 3 times weekly
* unable or unwilling to complete outcome assessments

Primary outcomes:
measure: feasibility (recruitment, adherence, safety)
Secondary outcomes:
measure: quality of life
measure: functional abilities
Other outcomes:
Locations:
city: Edmonton
country: Canada
facility: Cross Cancer Institute
state: Alberta
Study officials:
affiliation: Cross Cancer Institute
name: Kerry Courneya, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04405687: Postoperative Follow up After Head and Face Reconstructive Surgeries
Official title: Post-reconstructive Surgeries of Severe Head and Face Deformities: An Observational Follow-up Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Deformity of Face
Lead sponsor: Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
Sponsor class: OTHER
First posted: 2020-05-28
Enrollment: 50
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This clinical study will include patients treated by Prof. Li Qingfeng 's professional team who have undergone major head and face reconstructive surgeries before January 1, 2019.

It is estimated that about 85 patients will be enrolled in this study.

Brief summary: In this observational follow-up study, patients with type III-IV head and face soft tissue deformities/defects following reconstructive surgeries will be asked to fill out 3 questionnaires, either through phone calls or video calls, in order to evaluate the post-operative outcomes such as morphological and functional recovery, quality of life and patients' return to the community.

Detailed description: The objective of this follow up study is to evaluate the effectiveness and to analyze the limitations of the existing management and treatment of severe burn injuries. Investigation of the factors affecting the recovery and patients' return to the community in patients with severe burn injury may lead to effective amendments of the existing management, and thus aiding in the development of an integrated diagnosis and treatment guidelines.

Eligibility criteria: Inclusion Criteria:

1. Preoperative facial soft tissue deformities/defects of type III and IV
2. Major reconstructive surgery of the head and neck (flap transfer with revision at least once) performed before January 1, 2019.
3. Agreed and able to cooperate with the follow-ups, with signed informed consent form or audio recorded informed consent.

Exclusion Criteria:

1. Patients with mental illness, reduced cognitive capacity, unable to consent and unable to cooperate.
2. Minor patients without legal guardian.
3. Not willing to participate; informed consent form not signed.

Primary outcomes:
measure: SF-36 total score
timeFrame: 12 minutes
measure: Aesthetic & Functional total score (Patient edition)
timeFrame: 8 minutes
measure: EQ-5D-5L total score
timeFrame: 2 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Ninth People's Hospital
state: Shanghai
Study officials:
affiliation: Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
name: Tao Zan, MD, PhD
role: STUDY_DIRECTOR
References: