louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04613505: Determining Parental Attitudes Toward Day of Surgery Consent for Research
Official title: Determining Parental Attitudes Toward Day of Surgery Consent for Research
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Surgery
Consent
Lead sponsor: The Hospital for Sick Children
Sponsor class: OTHER
First posted: 2020-11-03
Enrollment: 214
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All participants receiving same day surgery at our institution are eligible to participate.

Brief summary: There are no studies examining parents' attitudes towards day of surgery consent for research. The purpose of the study is to determine the attitudes parents of potential research participants have toward being approached for day of surgery consent. The primary objective is to determine parental attitudes regarding day of surgery consent for anesthesia research. The secondary objective is to determine the boundaries for day of surgery consent (e.g., study types, interventions, risk factors).

Detailed description: This is a multi-phase prospective cohort study. In the first phase the investigators will interview parents and consult the Family Research Advisory Committee (FRAC) to determine their attitudes toward day of surgery research consent. The investigators will use the participants' responses and instruments already found in the literature to develop the questionnaire. In the second phase, the investigators will interview parents and consult FRAC about the questionnaire to determine which items to add, remove, or modify. In the third phase, the investigators will distribute the adapted questionnaire to clarify parents' attitudes surrounding day of surgery consent. The investigators will use the results of the third phase to develop a table of guidelines for day of surgery consent. In the final phase, the investigators will interview parents, healthcare professionals, and consult FRAC for feedback and modification of the table of guidelines.

Eligibility criteria: Inclusion Criteria:

* The parents of children undergoing elective surgical procedures at Sickkids will be invited to participate in the study.
* If multiple parents are present, they are permitted to participate jointly; however, their participation will count as a single response.

Exclusion Criteria:

-Parents of children who are undergoing urgent or add-on procedures will be excluded.

Primary outcomes:
measure: Parental attitude towards day of surgery consent
timeFrame: Day of surgery
Secondary outcomes:
measure: Boundary for day of surgery consent
timeFrame: Day of surgery
measure: Boundary for day of surgery consent
timeFrame: Day of surgery
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: The Hospital for Sick Children
state: Ontario
Study officials:
affiliation: Staff Anesthesiologist
name: Katherine Taylor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05892198: A Single Center Experience in the Management of Pilonidal Disease
Official title: A Single Center Experience in the Management of Pilonidal Disease; the Impact of Pits Location on the Choice of the Best Surgical Option.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pilonidal Sinus
Keywords: sacrococcygeal pilonidal sinus
primary closure
limberg flap
rotational flap
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2023-06-07
Enrollment: 101
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Sacrococcygeal pilonidal disease (PND) is a common entity affecting the skin and subcutaneous tissue of the upper portion of the natal cleft of the buttocks. It is characterized by the presence of sinus tracts with recurrent inflammation and infection. It poses a significant healthcare problem due to its related morbidity, impaired quality of life, and financial costs.

Detailed description: This acquired disease is caused by negative suction of the hair present in the natal cleft region, leading to a foreign body reaction and subsequent granuloma . It affects 26 per 100000 people, and it mainly affects young men . Surgery for PND is frequently performed in Egypt by general surgeons, with no published data regarding its incidence or prevalence in the Egyptian population.

The PND patient may report different presentations ranging from asymptomatic disease to acute infection and abscess formation. Others may have a chronic disease with recurrent perianal inflammation and discharge.

Multiple surgical options have been described for chronic PND. However, no technique has been universally accepted. The idea of any procedure is to excise the pits with the related sinus tracts leaving healthy tissue as possible to decrease recurrence. The most commonly performed surgical techniques include excision with either primary closure, lay open, or flap-based reconstruction.

Eligibility criteria: Inclusion Criteria:

* Both sexes
* aging between 18- 60 years old
* who underwent surgical intervention for the pilonidal sinus (Either primary or recurrent)
* The surgical intervention includes excision with primary closure or lay open technique, Rhomboid flap and rotational flap.

Exclusion Criteria:

* surgically unfit due to commodities.
* those who lost follow up

Primary outcomes:
measure: Select the best operative technique as regard the number and distribution of the pits in pilonidal sinus cases.
timeFrame: 6 months
measure: Recurrence rate
timeFrame: 6 months - 1 year
Secondary outcomes:
measure: the incidence of complications such as: wound infection, wound dehiscence, postoperative pain.
timeFrame: 1 month
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04434105: Ultrasound-guided PRP Versus Steroid Injections in Management of Carpal Tunnel Syndrome
Official title: Ultrasound-guided PRP Versus Steroid Injections in Management of Carpal Tunnel Syndrome; a Comparative Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Carpal Tunnel Syndrome
Keywords: PRP injection
Local injection
CTS
Lead sponsor: Tanta University
Sponsor class: OTHER
First posted: 2020-06-16
Enrollment: 90
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Patients will be randomly divided into 3 equal groups: Group I received ultrasound guided injection of 2 mL PRP into the affected carpal tunnel. Group II received ultrasound guided injection of 2 mL steroids (40 mg triamcinolone acetonide). Group III received ultrasound guided injection of 2 mL saline as placebo control.

Detailed description: Patients will be randomly divided into 3 equal groups: Group I received ultrasound guided injection of 2 mL PRP into the affected carpal tunnel. Group II received ultrasound guided injection of 2 mL steroids (40 mg triamcinolone acetonide). Group III received ultrasound guided injection of 2 mL saline as placebo control.

Each group will be injected twice with 2 weeks intervals. All procedures were done after informed consent. Evaluation of the patients at baseline, 3 and 6 months after last injection was done clinically by measuring visual analogue scale (VAS), electrophysiologically (by measuring motor and sensory nerve conduction studies of median nerve using a standardized technique) and ultrasonographic study by measuring cross sectional area (CSA) of median nerve at the level of pisiform.

Eligibility criteria: Inclusion Criteria:

* mild or moderate idiopathic CTS (diagnosed clinically, ultrasonography \& electrophysiologically and classified according to the American Association of neuromuscular diagnostic medicine monograph).

Exclusion Criteria:

* Patients with severe or secondary type of CTS

Primary outcomes:
measure: visual analogue scale
timeFrame: Change from 3 months after last injection and 6 months after last injection
measure: measuring motor and sensory nerve conduction studies of median nerve using a standardized technique
timeFrame: Change from 3 months after last injection and 6 months after last injection
measure: cross-sectional area (CSA) of the median nerve at the level of the pisiform.
timeFrame: Change from 3 months after last injection and 6 months after last injection
Secondary outcomes:
Other outcomes:
Locations:
city: Tanta
country: Egypt
facility: Tanta University Hospital
Study officials:
References:
citation: Malahias MA, Johnson EO, Babis GC, Nikolaou VS. Single injection of platelet-rich plasma as a novel treatment of carpal tunnel syndrome. Neural Regen Res. 2015 Nov;10(11):1856-9. doi: 10.4103/1673-5374.165322.
Clinical trial NCT03084705: Wearable Device for Motivating Hand Use After Stroke
Official title: An Interactive, Wearable Device for Measuring and Motivating Hand Use After Stroke
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cerebral Stroke
Lead sponsor: University of California, Irvine
Sponsor class: OTHER
First posted: 2017-03-21
Enrollment: 17
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: The goal of this study is to determine the effectiveness of interactive feedback from a wearable device that senses hand function, the Manumeter, in improving upper extremity function in a pilot, randomized controlled trial with chronic stroke patients

Detailed description: In this randomized controlled trial, the investigators will compare two groups of chronic stroke participants Group 1 of study participants will use the Manumeter with interactive functions to monitor and motivate upper extremity functional activity. Group 2 of study participants will use the Manumeter but receive no feedback and will be given the current standard-of-care, a booklet describing a home exercise program for increasing upper extremity exercise. The investigators hypothesize that study participants who interactively monitor functional activity with the Manumeter will improve their upper extremity function significantly more.

Eligibility criteria: Inclusion Criteria:

* 18 to 80 years of age
* Experienced one or multiple strokes at least six months previously
* Upper Extremity Fugl-Meyer Score \< 60 out of 66
* Absence of moderate to severe upper limb pain (\< 3 on the a 10 point visual-analog pain scale)
* Ability to understand the instructions to operate the device

Exclusion Criteria:

* 80 years of age and above
* Implanted pacemaker
* moderate to severe pain in affected arm
* severe tone in affected arm as measured on a standard clinical scale
* language problem that would prevent from properly understanding instructions
* currently pregnant
* difficulty in understanding or complying with the instructions given by the experimenter
* inability to perform the experimental task that will be studied

Primary outcomes:
measure: Box and Blocks Test (BBT)
timeFrame: 3 months
Secondary outcomes:
measure: Action Research Arm Test (ARAT)
timeFrame: 3 months
measure: Fugl-Meyer Motor Assessment (FM)
timeFrame: 3 months
measure: Motor Activity Log (MAL)
timeFrame: 3 months
measure: Amount of upper extremity activity
timeFrame: 3 months
Other outcomes:
Locations:
city: Irvine
country: United States
facility: University of California, Irvine
state: California
Study officials:
affiliation: University of California, Irvine
name: David Reinkensmeyer, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04853498: A Study to Evaluate the Tolerance and Pharmacokinetics of TQB3720 Tablets
Official title: A Phase I, Open-label, Dose Escalation and Expansion Study to Evaluate the Tolerance and Pharmacokinetics of TQB3720 Tablets
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Metastatic Castration-resistant Prostate Cancer
Lead sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2021-04-21
Enrollment: 120
Sex: MALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study is conducted to investigate the pharmacokinetic and safety profiles of TQB3720 in patients with metastatic castration-resistant prostate cancer.


Eligibility criteria: Inclusion Criteria:

* 1. Histologically or cytologically confirmed prostate carcinoma. 2.Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 2; Life expectancy ≥12 weeks.

  3.Testosterone levels \< 50 ng/dL. 4. Has received ≥1 previous regimens for metastatic castration-resistant prostate cancer.

  5.Male subjects should agree to use an adequate method of contraception starting with signing ICF through 6 months after the last dose of study.

  6.Understood and signed an informed consent form.

Exclusion Criteria:

-1.Has symptomatic brain metastases or control of symptoms \< 1 month. 2.Has other malignancies within 3 years. 3.Has used second-generation androgen receptor antagonists. 4. Abnormal liver function. 5. Abnormal renal function. 6. Has received any other investigational drug within 30 days weeks before first dose.

7. According to the judgement of the researchers, there are other factors that subjects are not suitable for the study.

Primary outcomes:
measure: Maximum tolerated dose (MTD)
timeFrame: Baseline up to 28 days
Secondary outcomes:
measure: Cmax
timeFrame: 0hour, 2hour, 4hour, 8hour, 12hour, 24hour, 36hour, 48hour, 72hour, 96hour,120hour post-dose on single dose; Hour 0 of day 8、day 15、day 22；0 hour, 2 hour, 4 hour, 8 hour, 12 hour, 24 hour post-dose on multiple dose of day 28; Hour 0 of day 42 and day 56.
measure: Tmax
timeFrame: 0hour, 2hour, 4hour, 8hour, 12hour, 24hour, 36hour, 48hour, 72hour, 96hour,120hour post-dose on single dose; Hour 0 of day 8、day 15、day 22；0 hour, 2 hour, 4 hour, 8 hour, 12 hour, 24 hour post-dose on multiple dose of day 28; Hour 0 of day 42 and day 56.
measure: AUC0-t
timeFrame: 0hour, 2hour, 4hour, 8hour, 12hour, 24hour, 36hour, 48hour, 72hour, 96hour,120hour post-dose on single dose; Hour 0 of day 8、day 15、day 22；0 hour, 2 hour, 4 hour, 8 hour, 12 hour, 24 hour post-dose on multiple dose of day 28; Hour 0 of day 42 and day 56.
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Fudan University Shanghai Cancer Center
state: Shanghai
Study officials:
References:
Clinical trial NCT01409798: The Midwest Head and Neck Cancer Consortium Multi-Institutional Parathyroid Registry
Official title: The Midwest Head and Neck Cancer Consortium Multi-Institutional Parathyroid Registry
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Primary Hyperparathyroidism
Keywords: Hyperparathyroidism
Hypercalcemia
Lead sponsor: University of Nebraska
Sponsor class: OTHER
First posted: 2011-08-04
Enrollment: 175
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Otolaryngology, Head and Neck Surgery clinic patients

Brief summary: The purpose of this registry is to create a database that collects clinical data to improve knowledge about primary hyperparathyroidism.

Detailed description: This will be a multi-institutional prospective study in which patients that have undergone parathyroidectomy with intra-operative PTH assessment. The success of minimally invasive parathyroidectomy without and with intra-operative PTH will be assessed for each patient. Success for exploration without intra-operative PTH will be defined as directed exploration with detection of an abnormal parathyroid in the location suggested by imaging. Success with intra-operative PTH will be defined as per standard protocols (50% or \> decrease in intra-operative PTH following excision).

Eligibility criteria: Inclusion Criteria:

* Adult individuals (male and female) who have a personal diagnosis/history of primary hyperparathyroidism.
* Age 19 or greater.
* Patients who are seen and treated surgically at UNMC's Department of Otolaryngology- Head Neck Surgery .
* Able to provide informed consent.

Exclusion Criteria:

-No history of primary hyperparathyroidism

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Iowa City
country: United States
facility: University of Iowa
state: Iowa
city: Lawrence
country: United States
facility: Kansas University Medical Center
state: Kansas
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
city: Columbia
country: United States
facility: University Of Missiouri
state: Missouri
city: Omaha
country: United States
facility: University of Nebraska Medical Center
state: Nebraska
city: Sioux Falls
country: United States
facility: Sanford School of Medicine
state: South Dakota
Study officials:
affiliation: University of Nebraska
name: Russell B Smith, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05481398: A Randomized Controlled Trial Evaluating the Role of Negative Pressure Wound Therapy (NPWT) for Incisional Surgical Site Infections in Patients Undergoing Hepatopancreatobiliary Surgery
Official title: Negative Pressure Wound Therapy (NPWT) for Incisional Surgical Site Infections in Patients Undergoing Hepatopancreatobiliary Surgery: A Randomized Controlled Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hepatobiliary Disease
Hepatobiliary Disorders
Surgical Site Infection
Keywords: Hepatopancreatobiliary surgery
Surgical site infection
Negative pressure wound therapy
Lead sponsor: Sindh Institute of Urology and Transplantation
Sponsor class: OTHER
First posted: 2022-08-01
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomization Patients will be randomly allocated into intervention group A (NPWT) or control group (B) by simple randomization.
Primary purpose: PREVENTION

Brief summary: To compare the rates of incisional surgical site infections (iSSIs) within 7 days of hepatopancreatobiliary (HPB) surgery using negative pressure wound therapy (NWPT) versus using standard sterile gauze dressing.


Eligibility criteria: Inclusion Criteria:

All patients undergoing elective open HPB surgery (benign or malignant disease) of age \> 18 years consenting to the study protocol.

Exclusion Criteria:

The patient in which primary wound closure is not achieved. The patient planned for a second look surgery. The patient with the history of long-term antibiotic use (more than a month). Past history of open abdominal surgery (less than 1 month).

Primary outcomes:
measure: Rate of incisional surgical site infections (iSSIs)
timeFrame: within 7 days of hepatopancreatobiliary (HPB) surgery
Secondary outcomes:
measure: Wound infections
timeFrame: day 7 till 30 days following HPB surgery
measure: Surgical site complication
timeFrame: within 30 days of HPB surgery
measure: Rate of fascial dehiscence
timeFrame: within 30 days of HPB surgery
measure: Antibiotic therapy
timeFrame: Day 1 to day 30
measure: Length of hospital stay.
timeFrame: Day 1 to day 30
Other outcomes:
Locations:
city: Karachi
country: Pakistan
facility: Sindh Institute of Urology and Transplantation
state: Sindh
Study officials:
affiliation: Sindh Institute of Urology and Transplantation
name: Uzma Soomro
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06785298: Fexofenadine As Adjuvant Therapy in Parkinson Disease
Official title: Clinical Study to Evaluate the Possible Efficacy and Safety of Fexofenadine in Patients with Parkinson's Disease Treated with Conventional Treatment
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
PHASE3
Conditions: Parkinson Disease
Keywords: Fexofenadine
Lead sponsor: Tanta University
Sponsor class: OTHER
First posted: 2025-01-21
Enrollment: 46
Sex: ALL
Minimum age (years): 50
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Parkinson's disease (PD) is a chronic, progressive neurological disorder characterized by both motor and non-motor symptoms. PD is the second most common neurodegenerative disorder after Alzheimer's disease and the most common movement disorder. PD has age-related pathology; it is present in 1-2% of the population over 60 years of age. The disease is characterized by a triad of disordered voluntary motor activity in the form of bradykinesia (slowness of movement) or even akinesia (absence of movement),rigidity and postural instability, and a resting tremor of the hands and less commonly the feet.


Eligibility criteria: Inclusion Criteria:• Age ≥ 50 years. Both male and female will be included. Patients with Parkinson's disease on dopamine replacement therapy. Modified Hoehn and Yahr stage, MHY 1-4

Exclusion Criteria:• Atypical parkinsonism or drug-induced parkinsonism Breast feeding Pregnant women and women with planned pregnancy. Patients with significant liver and kidney function abnormalities. History/presence of acute heart disease Alcohol and / or drug abusers. Patients with known allergy to the study medications Other medical conditions that can interfere with results or endanger the participant.

Primary outcomes:
measure: The primary outcome is the change in quality of life in Parkinson's disease by Unified Parkinson's Disease Rating Scale
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Tanta
country: Egypt
facility: Tanta University
Study officials:
References: