louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06397014: The Clinical Applications of D-type Parastomal Hernia Repair Surgery
Official title: The Clinical Applications of D-type Parastomal Hernia Repair Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hernia Repair
Stoma Reconstruction
Function and Appearance
Lead sponsor: Northern Jiangsu People's Hospital
Sponsor class: OTHER
First posted: 2024-05-02
Enrollment: 91
Sex: ALL
Minimum age (years): 60
Maximum age (years): 80
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 parastomal hernia

Brief summary: During the period from February 2018 to February 2022, a study was conducted on patients with parastomal hernia.There were 23 patients who underwent repair surgery for D-type colostomy hernia, while 68 patients underwent traditional laparoscopic repair surgery for hernia.The inclusion criteria were: (1) preoperative diagnosis of parastomal hernia by CT scan; (2) underwent laparoscopic repair surgery or combined laparoscopic repair with abdominal wall and stoma reconstruction surgery.The exclusion criteria were: (1) occurrence of tumor recurrence and/or new tumors during the follow-up period; (2) death or loss to follow-up during the follow-up period.


Eligibility criteria: Inclusion Criteria:

(1) preoperative diagnosis of parastomal hernia by CT scan; (2) underwent laparoscopic repair surgery or combined laparoscopic repair with abdominal wall and stoma reconstruction surgery.

Exclusion Criteria:

(1) occurrence of tumor recurrence and/or new tumors during the follow-up period; (2) death or loss to follow-up during the follow-up period.

Primary outcomes:
measure: postoperative recurrence rate
timeFrame: 2018-2024
measure: treatment cost
timeFrame: 2018-2024
Secondary outcomes:
Other outcomes:
Locations:
city: Yangzhou
country: China
facility: Northern Jiangsu People's Hospital
state: Jiangsu
Study officials:
References:
Clinical trial NCT00121914: Treatment of Hepatocellular Carcinoma: Long-Acting Somatostatin Plus Percutaneous Ethanol Instillation (PEI) Versus Long-Acting Somatostatin Alone
Official title: Treatment of Hepatocellular Carcinoma: A Randomized Controlled Study With Long-Acting Somatostatin Plus Percutaneous Ethanol Instillation (PEI) Versus Long-Acting Somatostatin Alone
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Carcinoma, Hepatocellular
Keywords: Carcinoma, Hepatocellular,
percutaneous ethanol instillation
long-acting somatostatin
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2005-07-21
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Hepatocellular carcinoma (HCC) is a consequence of liver cirrhosis. In early tumour stages, tumour resection or liver transplantation are therapeutic options; later tumour stages may be treated with locally ablative treatments such as percutaneous ethanol instillation (PEI), transarterial chemoembolization (TACE) or radio-frequency thermoablation. This randomized study investigates the effect of PEI on survival of patients with HCC. All patients will receive hormonal treatment (long-acting somatostatin intramuscularly \[i.m.\]) and will be randomized for treatment with PEI or no additional treatment.

Detailed description: This is a randomized two-arm parallel group study.

* Study group: PEI + long-acting somatostatin
* Control group: long-acting somatostatin alone

Aims of the study:

* Does treatment with PEI+ long-acting somatostatin prolong survival as compared to treatment with long-acting somatostatin alone?
* Can time to tumour progression be extended in patients treated with PEI + long-acting somatostatin as compared to treatment with long-acting somatostatin alone?

Eligibility criteria: Inclusion Criteria:

* Histologically-proven hepatocellular carcinoma
* Treatable with percutaneous ethanol instillation
* Inoperable tumour
* Age 18-85 years

Exclusion Criteria:

* Liver cirrhosis Child C
* Tumour diameter \> 8 cm

Primary outcomes:
measure: survival time
measure: time to tumour progression
Secondary outcomes:
measure: quality of life
measure: causes of death
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Universitaetsklinik fuer Innere Medizin IV / Gastroenterologie und Hepatologie
Study officials:
affiliation: Universitaetsklinik fuer Innere Medizin IV
name: Christian Mueller, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Muller C, Schoniger-Hekele M, Schernthaner R, Renner B, Peck-Radosavljevic M, Brichta A, Wrba F, Posch M, Bauer P, Ferenci P, Gangl A. Percutaneous ethanol instillation therapy for hepatocellular carcinoma - a randomized controlled trial. Wien Klin Wochenschr. 2008;120(19-20):608-18. doi: 10.1007/s00508-008-1086-2.
Clinical trial NCT06182514: What Are the Main Themes Concerned by the Second-line SMUR 67, Known as Reinforcements, in the Bas-Rhin Sector
Official title: State of Play at the SAMU 67: What Are the Themes Mainly Concerned by the Second Intention SMUR, Called Reinforcements, on the Sector of the Bas-Rhin? Are There Modifiable Factors That Could Allow us to Anticipate Them Better
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Reasons for Emergency Calls
Keywords: emergency calls
SAMU67
SMUR
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2023-12-27
Enrollment: 1200
Sex: ALL
Minimum age (years): 1
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients having benefited from a pre-hospital SMUR over the period from 01/01/2020 to 14/07/2020.

Brief summary: In this study the investigators wish to evaluate the possibility of anticipating the requests for SMUR reinforcement within the SAMU67.

The studied population concerns each patient having benefited from an SMUR at the time of his pre-hospital care. The investigators expect from this study an improvement of the assumption of responsibility of the patients in the future with optimization of the delay of sending of an SMUR when this one is necessary.


Eligibility criteria: Inclusion criteria:

* Adult patients having benefited from a pre-hospital SMUR over the period from 01/01/2020 to 14/07/2020.
* No opposition from the patient or his parental authority to the re-use of his medical data for scientific research.

Exclusion criteria:

- Presence of opposition from the patient or his parental authority to the re-use of his medical data for scientific research purposes.

Primary outcomes:
measure: Retrospective description of the main reasons and themes of patient calls leading to the Emergency Medical Service being sent for reinforcement
timeFrame: Through study completion, an average of 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Service d'Urgences Médico-Chirurgicales Adules
Study officials:
References:
Clinical trial NCT04730414: Full Spectrum Hemp Observational Study
Official title: Acne Vulgaris Blemish Full Spectrum Hemp Observational Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Acne Vulgaris
Acne Vulgaris Superficial Mixed Comedonal and Inflammatory
Keywords: Blemishes
Lead sponsor: Charlotte's Web, Inc
Sponsor class: INDUSTRY
First posted: 2021-01-29
Enrollment: 50
Sex: ALL
Minimum age (years): 13
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Inclusive of genders, adolescents to elderly, ethnicities, and must present with facial blemishes.

Brief summary: In westernized societies, acne vulgaris is nearly a universal skin disease afflicting 79% to 95% of the adolescent population; older than 25 years - 40% to 54% have facial blemishes and persists into middle age in 12% of women and 3% of men. Standard treatment modalities present with high risk morbidities. Charlotte's Web hemp blemish product is predicted to significantly reduce the risks mentioned above, while improving efficacy as well as imparting other skin benefits.

Detailed description: Charlotte's Web Full spectrum hemp blemish product will contain a mere 0.018% THC and will therefor not impart a psychotic affect. Hemp has been shown to be well tolerated in humans and has a very acceptable dosage, efficacy and safety profile when topically applied. The FDA has labeled hemp as Generally Regarded As Safe (GRAS) and as such reduces the risk of severe adverse reactions to the subject.

Benefits of hemp blemish 'cream" is that it has been formulated in such a way as to promote natural skin balance, and may eliminate skin dryness, inflammation, hyperpigmentation, and scaring.

The primary objective and endpoint of the study is to obtain total eradication of the blemish eruptions. The secondary objective and endpoints is the continued use of the hemp product will continue to prevent further blemish eruptions and provide other skin benefits especially reducing the propensity to scar.

Eligibility criteria: Inclusion Criteria:

* Male/female
* Diagnosed acne vulgaris
* Not on current acne treatment(s) or off current treatment for 2 weeks
* 13-70 yrs old

Exclusion Criteria:

* Not willing to stop current acne treatment(s)
* males that present with facial hair
* active TB, HIV or hepatitis
* pregnant or lactating females

Primary outcomes:
measure: Facial Blemishes
timeFrame: 2-3 months
Secondary outcomes:
measure: Improvement of overall skin tone
timeFrame: 2-3-6 months
Other outcomes:
measure: Social Benefits of Full Spectrum Hemp
timeFrame: 2-3-6 months
Locations:
Study officials:
affiliation: Charlottes Web, Inc
name: Jeff Lokken
role: STUDY_DIRECTOR
References:
Clinical trial NCT05912855: To Investigate the Impact of Analgesic Management Guided by qNOX Monitoring on the Comfort and Prognosis of Mechanically Ventilated ICU Patients
Official title: To Investigate the Impact of Analgesic Management Guided by qNOX Monitoring on the Comfort and Prognosis of Mechanically Ventilated ICU Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Pain
Lead sponsor: Tianjin Medical University General Hospital
Sponsor class: OTHER
First posted: 2023-06-22
Enrollment: 110
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: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: ICU patients receiving mechanical ventilation.

Brief summary: Purpose: To explore the effect of analgesic management under the guidance of qNOX monitoring on the comfort level and prognosis of patients with mechanical ventilation in ICU.

Method:After admission to ICU, the patients were randomly divided into the analgesia group guided by BPS（Behavioral Pain Scale） and physiological indicators monitoring and qNOX-guided analgesia group (qNOX group). Sedation and analgesia program after admission to ICU (continuous injection pump) : propofol 1.5-4.5mg/kg.h, remifentanil 5-8ug/kg.h, maintain sedation goals RASS（Richmond Agitation-Sedation Scale）-3 to -4 scores, BPS（Behavioral Pain Scale）3 to 4 scores. The researchers worked with the bedside nurse to plan different care procedures, including :1) central venous catheter or arterial catheter puncture; 2) The patient is turned over completely so that the back can be washed and the sheets changed; 3) Endotracheal sputum aspiration (patients with intubation or in tracheotomy state ); 4) Dressing the wound.

Primary outcome:Value of qNOX at BPS（Behavioral Pain Scale）≥5 (qNOX sensitivity, specificity, positive predictive value and negative predictive value) Secondary outcome:To investigate the patient baseline variables that may affect qNOX; Variables that may influence qNOX in relation to critical illness.


Eligibility criteria: Inclusion Criteria:

1. Patients aged 18 years or older who are undergoing abdominal, orthopedic, ENT（ear-nose-throat）, urological, neurosurgical or cardiothoracic surgery and require ICU treatment with mechanical ventilation while having an RASS（Richmond Agitation-Sedation Scale）-3 or -4 score;
2. Patients unable to self-assess pain intensity using NRS（Numerical Pain Rating Scale）;
3. Patients who have provided informed consent.

Exclusion Criteria:

1. \< 18 years of age;
2. Pregnant individuals;
3. Patients with communication impairments, such as those who have experienced cerebrovascular accidents;
4. A decision to withdraw life-sustaining treatment or an unstable medical condition that disrupts planned routine care.

Primary outcomes:
measure: Value of qNOX with BPS≥5
timeFrame: During procedure
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02509455: Balance Measures During Stance and Gait: Comparison of Gyroscopic Measurements of Trunk Sway
Official title: Quantified Balance Measures During Stance and Gait: Comparison of a New Micro-mechanical Gyro-system (Sensoro Von Hocoma AG) With SwayStar (Balance Int. Innov.) for Measurements of Balance Control of Healthy Controls.
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Healthy
Keywords: Balance control
Body-mounted sensors
Balance Measures
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
First posted: 2015-07-28
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy adults

Brief summary: To investigate whether an extended version of Valedo®Motion (termed Sensoro for brand management purposes), has the same trunk sway measures similar normal reference values of SwayStar. Offline data analysis of data obtained from Sensoro will be compared to data obtained by SwayStar, a highly accurate and widely accepted system for measuring balance control.

Detailed description: 1. Determine a long time recording (over 60s) description of any differences in the drift and noise for the 2 systems during simultaneous recordings with the systems aligned with each other at rest.
2. Compare Sensoro trunk sway measures with those of SwayStar for a battery of 17 stance and gait tasks. The tasks to range from tasks with small velocities (standing on 2 legs eyes open, ca 0.1 deg/s or eyes closed on foam ca.10 deg/s) through tandem and gait tasks with velocities of ca 70 deg/s to the most dynamic with high velocities (rising from a chair, ca 150 deg/sec).
3. Estimate the additional value of adding trunk sway values for the yaw axis as an outcome measure of balance control.
4. Estimate the advantage of adding one or two sensors on the legs to help identify gait balance events and body posture.

Eligibility criteria: Inclusion Criteria:

* self reported lack of balance problems (checked by the ability to stand on 1 leg, eyes closed, for at least 14 secs).

Exclusion Criteria:

* orthopaedic problems
* presence of diseases which cause balance problems.

Primary outcomes:
measure: Trunk sway angular velocity and displacement stance and gait tasks.
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: Lab for Exp Otoneurology, University Hospital Basel
Study officials:
affiliation: University Hospital, Basel, Switzerland
name: John HJ Allum, DSc
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04568655: The Noninvasive Ventilation to COVID-19 Patients
Official title: The Noninvasive Ventilation to COVID-19 Patients With Respiratory Failure
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Noninvavie Ventilation to Patients With COVID-19
Keywords: noninvavie ventilation
COVID-19
respiratory failure
Lead sponsor: The First Affiliated Hospital of Guangzhou Medical University
Sponsor class: OTHER
First posted: 2020-09-29
Enrollment: 23
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: respiratory failure patients with COVID-19

Brief summary: Noninvasive ventilation(NIV) is an important treatment to the respiratory failure patients.The severe Corona Virus Disease-19(COVID-19) patients are incline to respiratory failure.The NIV may reduce the intubtion rate.This research was taken to investigate the factor to the success of the noninvasive ventilation to the COVID-19 patients with respiratory failure.

Detailed description: Noninvasive ventilation(NIV) is an important treatment to the respiratory failure patients.The severe Corona Virus Disease-19(COVID-19) patients are incline to respiratory failure.The NIV may reduce the intubtion rate.This research was taken to investigate the factor to the success of the noninvasive ventilation to the COVID-19 patients with respiratory failure.We wish to raise the success rate to COVID-19 patients with respiratory failure.More critically ill COVID-19 patients could avoid the intubtion.

Eligibility criteria: Inclusion Criteria:

1. Shortness of breath, RR\>30 times per minute;
2. At room air, SpO2 lower than 93%;
3. The partial pressure of Arterial blood oxygen (PaO2)/the fraction of inspired oxygen (FiO2) ≤ 300mmHg;
4. CT（computed tomography） chest imaging shows that lung damage develops significantly within 24 to 48 hours.

Exclusion Criteria:

1. Severe cardiovascular disease,
2. respiratory arrest,
3. cardiovascular instability (hypotension, arrhythmias, myocardial infarction),
4. change in mental status or patients who were uncooperative, high risk of aspiration, viscous or copious
5. secretions,
6. recent facial or gastroesophageal surgery,
7. craniofacial trauma, 8)fixed nasopharyngeal abnormalities,

9）burns, 10) extreme obesity.

Primary outcomes:
measure: success rate
timeFrame: 4 month
measure: the intubtion rate
timeFrame: 4 month
Secondary outcomes:
measure: blood lymphocyte
timeFrame: 4month
measure: B-type natriuretic peptide
timeFrame: 4 month
measure: Procalcitonin
timeFrame: 4 month
measure: Oxygen Saturation
timeFrame: 4 month
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: The First Affiliated Hospital of Guangzhou Medical University
state: Guangdong
Study officials:
References:
Clinical trial NCT04852055: Effect of an Advance Care Planning Intervention
Official title: Effect of an Advance Care Planning Intervention on Documentation of Advance Directives and Goals of Care in Assisted Living Centers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dementia
Keywords: assisted living facilities
dementia
advance care planning
Lead sponsor: Brown University
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2021-04-21
Enrollment: 2611
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The intervention being studied is an advance care planning intervention. The trial has two arms: usual care and information arm.

Detailed description: Eligible patients whose assisted living centers are randomized to the information arm will receive a letter from their clinician with links to informational video. Eligible patients whose assisted living centers are randomized to the usual care arm have advance care planning discussions with a clinician at admission, annually, and sometimes with a hospitalization or other change in condition.

Eligibility criteria: Inclusion Criteria:

* Partnering assisted living center with at least 20 patients with a dementia diagnosis (based on International Classification of Diseases, version 10 codes)
* Patients not on hospice
* Patients who do not have comfort care or do-not-hospitalize orders at baseline

Exclusion Criteria:

* Partnering assisted living center with less than 20 patients with a dementia diagnosis (based on International Classification of Diseases, version 10 codes)
* Patients on hospice
* Patients with comfort care or do-not-hospitalize orders at baseline

Primary outcomes:
measure: Do-Not-Resuscitate
timeFrame: 4 months
Secondary outcomes:
measure: Do-Not-Hospitalize
timeFrame: 4 months
measure: Advance Care Planning Billing
timeFrame: 4 months
measure: Hospitalization
timeFrame: 4 months
Other outcomes:
Locations:
city: Stillwater
country: United States
facility: Bluestone Physician Services
state: Minnesota
Study officials:
affiliation: Brown University, School of Public Health
name: Vincent Mor, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05274555: Reliability and Validity of the Turkish Version of the Upper Limb Short Questionnaire in Duchenne Muscular Dystrophy
Official title: Reliability and Validity of the Turkish Version of the Upper Limb Short Questionnaire in Duchenne Muscular Dystrophy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Duchenne Muscular Dystrophy
Upper Extremity Problem
Lead sponsor: Dokuz Eylul University
Sponsor class: OTHER
First posted: 2022-03-10
Enrollment: 41
Sex: MALE
Minimum age (years): 5
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: This study was planned as a methodological research. A total of 41 children with DMD between the ages of 5-18 were included in the study.

Brief summary: Purpose: This study aimed to evaluate the construct validity and reliability of the Turkish version of the Upper Limb Short Questionnaire (ULSQ) in Duchenne muscular dystrophy (DMD).

Materials and methods: A total of 41 children with DMD have participated in the study. Upper and lower extremities functional levels were assessed with Vignos Scale and Brooke Upper Extremity Functional Rating Scale, respectively. The construct validity of the questionnaire was determined using the correlation between the ULSQ and ABILHAND-Kids. The Cronbach alpha value was calculated to determine internal consistency. To determine test-retest reliability, 17 randomly selected children were evaluated seven days after the first evaluation, and the "Intraclass Correlation Coefficient (ICC)" value was calculated.


Eligibility criteria: Inclusion Criteria:

* being diagnosed with DMD, being between the ages of 5-18, not having any additional neurological disorder, volunteering to participate in the research

Exclusion Criteria:

* patients diagnosed after 10 years of age, patients who had never taken corticosteroids, and patients aged 14 years or older but were still ambulatory

Primary outcomes:
measure: Upper Limb Short Questionnaire
timeFrame: 2 years
measure: ABILHAND-Kids
timeFrame: 2 years
measure: The Vignos Scale
timeFrame: 2 years
measure: The Brooke Upper Extremity Functional Rating Scale
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Izmir
country: Turkey
facility: Dokuz Eylul University
Study officials:
References: