louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04039282: Exploring the Use of myfood24 (an Online Nutritional Assessment Tool) in Clinical Dietetic Practice
Official title: Exploring the Use of myfood24 (an Online Nutritional Assessment Tool) in Clinical Dietetic Practice
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Nutritional Disorders
Nutrition Therapy
Food Habits
Keywords: nutrition
dietary recall
Lead sponsor: Sheffield Teaching Hospitals NHS Foundation Trust
Sponsor class: OTHER
Collaborators: name: University of Sheffield
name: British Dietetic Association
name: Dietary Assessment Ltd
First posted: 2019-07-31
Enrollment: 56
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: Dietary assessment is a key component of the dietetic care process. Assessments usually take place within dietetic consultations using methods such as 24-hour recall and paper food diaries. This study will examine the feasibility of using an online dietary assessment tool, myfood24 as an alternative to current dietary assessment practices and explore the barriers and facilitators to its use within dietetic clinical practice. This will be a mixed method study using questionnaires and semi structures interviews with both dietitians and patients. Dietitians, and patients with a range of clinical conditions referred to an NHS Dietetic Service, will be recruited. Patients will be asked to trial the system to record their food intake prior to their dietetic appointment. This data will then be used for the dietary assessment within the consultation. Following this, patients and dietitians will be interviewed about their experiences. Quantitative data will be statistically analysed, and thematic analysis will be used to analyse qualitative data.


Eligibility criteria: Inclusion Criteria:

* Aged over 18 years
* Referred to the STH Dietetic Department
* Willing and able to attend a dietetic out-patient appointment
* Can read and understand English
* Have access to the internet
* Willing to engage in technology as part of their care
* Have or willing to obtain their own email address

Exclusion Criteria:

* Under 18 years
* Unable or unwilling to attend a dietetic out-patient appointment
* Unable to read and understand English
* No access to the internet
* Unwilling to engage in technology as part of their care
* Does not have or unwilling to obtain their own email address

Primary outcomes:
measure: System Usability
timeFrame: After patients have used the system. Approximately 4 to 8 weeks after baseline.
Secondary outcomes:
measure: Patient Activation
timeFrame: Baseline and end of intervention. (approximately 3 months from baseline)
measure: Acceptability of using the system as part of dietetic care
timeFrame: The acceptability questionnaire and interviews will be completed at the end of the intervention.(approx 3 months from baseline)
Other outcomes:
Locations:
city: Sheffield
country: United Kingdom
facility: Sheffield Teaching Hospitals
Study officials:
References:
Clinical trial NCT05686382: TAP Block vs CWI for Total Abdominal Hysterectomy, a RCT
Official title: Anestesia Generale + TAP Block vs Anestesia Generale + CWI Per Intervento di Isterectomia Totale Laparotomica. Trial Randomizzato Controllato.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Postoperative Pain
Lead sponsor: Campus Bio-Medico University
Sponsor class: OTHER
First posted: 2023-01-17
Enrollment: 32
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This no-profit, monocentric, prospective randomized controlled trial, aims to demonstrate the non-inferiority of continuous wound infusion (CWI) when compared to transversus abdominis plane (TAP) block for postoperative pain control after total abdominal hysterectomy.

Detailed description: After signing the informed consent, patients will be enrolled and randomly allocated into either the study group (CWI) or the control group (TAP). Both groups will receive standard general anesthesia. At the end of the surgery, the CWI patients will receive a preperitoneal catheter in the surgical wound and CWI of ropivacaine 2 mg/ml, 5 ml/h for 24 hours; with the TAP block patients will receive a bilateral, standard lateral TAP block with 5 mg/ml ropivacaine 24 ml per side. All patients will receive multimodal analgesia with ketorolac 30 mg e.v. plus 90 mg/24h IV, paracetamol 1g plus 1g TID, dexamethasone 0,1 mg/kg IV preoperatively, oxycodone 5 mg per OS upon request.

Eligibility criteria: Inclusion Criteria:

* ASA I - III
* laparotomic hysterectomy with Pfannenstiel incision
* signed informed consent

Exclusion Criteria:

* ASA IV
* allergy to local anesthetics or other components of multimodal analgesia
* inability to walk or eat

Primary outcomes:
measure: opioid consumption
timeFrame: Change from baseline and hours 6, 12, 24, 48
Secondary outcomes:
measure: postoperative pain at rest
timeFrame: hours 6, 12, 24, 48
measure: postoperative pain during movements
timeFrame: hours 6, 12, 24, 48
measure: Postoperative Nausea and Vomiting (PONV)
timeFrame: hours 6, 12, 24, 48
measure: early refeeding
timeFrame: hours 3, 12, 24, 48
measure: early mobilization SIT-STAND-WALK
timeFrame: hours 3, 12, 24, 48
measure: vital parameters stability YES/NO
timeFrame: hours 3, 12, 24, 48
measure: vital parameter ( heart rate) stability YES/NO
timeFrame: hours 3, 12, 24, 48
measure: vital parameter (oxygen saturation) stability YES/NO
timeFrame: hours 3, 12, 24, 48
measure: Home dischargeable YES/NO
timeFrame: hours 3, 12, 24, 48
measure: complications
timeFrame: hours 0, 6, 12, 24, 48 (days 30 for DVT)
measure: HCP time consuming
timeFrame: hour 0
measure: Costs of all procedure
timeFrame: hour 0
Other outcomes:
Locations:
city: Rome
country: Italy
facility: CampusBioMedico
Study officials:
affiliation: Fondazione Policlinico Universitario Campus Biomedico di Roma
name: Fabio Costa, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02441582: The Effect of 12 Lead ECG Telemetry on Reperfusion Time in Resource-limited Settings
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Myocardial Infarction
STEMI
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
Collaborators: name: ER24
name: University of Stellenbosch
name: Philips Healthcare
First posted: 2015-05-12
Enrollment: 19
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This study aims to determine whether prehospital 12 lead ECG telemetry decreases the time to reperfusion in patients presenting with STEMI. A randomised controlled trial will be conducted in Gauteng and the Western Cape among 100 adult patients (\>18 years) presenting with ST-elevation myocardial infarction according to a specific inclusion and exclusion criteria outlined in the full protocol. Consenting patients will be randomly assigned to have their prehospital ECG sent to the receiving cardiac facility or not. The onset-to-reperfusion and door-to-reperfusion times will be recorded and compared between the two groups by using the Fisher's exact test and a simple unpaired Student's t-test. Data will also be subjected to multivariate analysis of variance to test for statistical significance within a variety of factors that may influence reperfusion times.


Eligibility criteria: Inclusion Criteria:

* Adult patients (\> 18 years of age)
* Patients presenting within the Gauteng or Western Cape areas
* Current chest pain or dyspnoea, presumed to be of cardiac origin
* ST-elevation (STEMI) on the ECG (defined as ST-elevation of 0.1 mV in two or more contiguous leads).

Exclusion Criteria:

* Non-adult patients
* Chest pain of non-cardiac aetiology (following trauma or due to a primary respiratory pathology)
* Non-consent to inclusion within the study
* Patients without medical aid or who states that they cannot afford private healthcare.
* Non-ST-elevation myocardial infarction

Primary outcomes:
measure: Reperfusion Time
timeFrame: At the first moment of reperfusion, from the date of randomisation up to 14 days
Secondary outcomes:
measure: Prehospital Time
timeFrame: On arrival at hospital; from the time of randomisation up to six hours
measure: Onset to reperfusion time
timeFrame: At the first moment of reperfusion, from the date of randomisation up to 14 days
Other outcomes:
Locations:
city: Johannesburg
country: South Africa
facility: ER24 Gauteng Region
state: Gauteng
city: Cape Town
country: South Africa
facility: ER24 Western Cape Region
state: Western Cape
Study officials:
References:
Clinical trial NCT02436382: Hypothermia and the Effect of Ambient Temperature
Official title: The Impact of Ambient Operative Room Temperature on Neonatal and Maternal Hypothermia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypothermia
Lead sponsor: University of Texas Southwestern Medical Center
Sponsor class: OTHER
First posted: 2015-05-06
Enrollment: 846
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Neonatal hypothermia is associated with increased risk of mortality as well as multiple morbidities. The investigators objective is to determine if an increase in ambient operative room temperature decreases the rate of hypothermia. Operating room temperature will be randomized to the current institutional standard (67°F) or a temperature of 73°F on a weekly basis for a period of six months.


Eligibility criteria: Inclusion Criteria:

* All pregnant women and their neonates undergoing cesarean delivery by the Parkland Hospital Obstetrics Service on the Labor and Delivery "West" Unit (operating rooms 1, 2, 3, and 5) during the study period.

Exclusion Criteria:

* Subjects will be excluded from the study if cesarean delivery is planned but a precipitous vaginal delivery occurs, intrauterine fetal demise has been diagnosed prior to start of surgery, the neonate is noted to have a major congenital anomaly, resuscitative efforts are not performed ("comfort care only" provided), or a neonatal temperature is not available.

Primary outcomes:
measure: neonatal hypothermia
timeFrame: up to 2 hours following delivery
Secondary outcomes:
measure: maternal hypothermia
timeFrame: up to 10 hours following delivery
Other outcomes:
measure: neonatal hypoglycemia
timeFrame: up to 8 hours following delivery
Locations:
city: Dallas
country: United States
facility: Parkland Memorial Hospital
state: Texas
Study officials:
References:
Clinical trial NCT05694182: The Safety and Efficacy of an Oral Superfruits Supplement
Official title: The Safety and Efficacy of an Oral Superfruits Supplement for Skin Brightening and Wrinkle Reduction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Lead sponsor: Ungku Shahrin Medical Aesthetic Research & Innovation (USMARI) Centre
Sponsor class: INDUSTRY
First posted: 2023-01-23
Enrollment: 15
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: This study is conducted to evaluate the safety and effectiveness of an oral superfruits supplement for skin brightening and wrinkle reduction. Superfruits are reported to have high bioactive compounds with beneficial effects on human health. The study duration is 12 weeks and the skin assessment will be carried out at baseline, week 2, week 6 and week 12. The participants will consume the supplement for 6 weeks and at week 12, final skin assessment will be conducted. The main questions this study aims to answer are:

1. The skin brightening effect of the oral superfruits supplement.
2. The effect of the oral superfruits supplement on wrinkle reduction.
3. To observe any adverse effect occurrence with the consumption of the oral superfruits supplement.


Eligibility criteria: Inclusion Criteria:

* Malaysian citizen
* Male and female (age 20-60 years old)

Exclusion Criteria:

* Participant who taking any dietary supplements for the past 4 weeks which can affect the study results
* Participant who are on contraceptive pills for the past 3 months
* Participant who undergo cosmetics treatments such as botox, filler and laser and light treatment within the last 3 months
* Pregnant or plans to get pregnant and breastfeeding women

Primary outcomes:
measure: Changes in skin tone from baseline and at week 2, week 6 and week 12 after consumption of the superfruits supplement
timeFrame: Baseline, week 2, week 6 and week 12
measure: Changes in skin wrinkles from baseline and at week 2, week 6 and week 12 after consumption of the superfruits supplement
timeFrame: Baseline, week 2, week 6 and week 12
measure: Adverse effect after consumption of the superfruits supplement
timeFrame: Week 12
Secondary outcomes:
Other outcomes:
Locations:
city: Petaling Jaya
country: Malaysia
facility: Ungku Shahrin Medical Aesthetic Research & Innovation (USMARI) Centre
state: Selangor
Study officials:
References:
Clinical trial NCT00322582: The Genetic Basis for Familial Cardiomyopathy in Patients With Idiopathic Cardiomyopathy
Official title: Open Labeled of the Study the Genetic Basis for Familial Cardiomyopathy in Patients With Idiopathic
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Cardiomyopathy
Keywords: familial cardiomyopathy
genetics analysis
Lead sponsor: Carmel Medical Center
Sponsor class: OTHER
First posted: 2006-05-08
Enrollment: 41
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: FAMILY_BASED
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: History of cardiomyopathy

Brief summary: In many of the patients with cardiomyopathy, the etiology is not clear . In about 30% there is a family history of cardiomyopathy .Our aim is to study the genetics basis for these patients with cardiomyopathy with no clear etiology and who have a first degree family relative with cardiomyopathy as well.

Detailed description: A total of 950 blood samples will be collected from patients with idiopathic cardiomyopathy and their relatives and will be analysed for genetics analysis.

Eligibility criteria: Inclusion Criteria:

* history of cardiomyopathy
* etiology not known
* family history of cardiomyopathy
* ability to understand and sign the informed consent

Exclusion Criteria:

* refusal to participate
* pregnancy
* current participation in another active treatment study

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Haifa
country: Israel
facility: Carmel Medical Center
Study officials:
affiliation: Lady Davis Carmel Hospital
name: Offer Amir, MD
role: STUDY_DIRECTOR
References:
citation: Murphy RT, Starling RC. Genetics and cardiomyopathy: where are we now? Cleve Clin J Med. 2005 Jun;72(6):465-6, 469-70, 472-3 passim. doi: 10.3949/ccjm.72.6.465.
Clinical trial NCT03232320: Meditoxin® Treatment in Patients With Cervical Dystonia
Official title: A Prospective, Randomized, Multi-center, Phase III, Double-blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of MEDITOXIN in Treatment of Cervical Dystonia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Dystonia
Dystonic Disorder
Lead sponsor: Medy-Tox
Sponsor class: INDUSTRY
First posted: 2017-07-27
Enrollment: 66
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To determine the efficacy and safety of Meditoxin in subjects with cervical dystonia compared with placebo (normal saline)


Eligibility criteria: Inclusion Criteria:

* Male or female aged 20 to less than 75 years
* Subjects requiring treatment for a clinical diagnosis of cervical dystonia with Toronto Western Spasmodic Torticollis Rating Scale(TWSTRS)-Total Score \>=20 and TWSTRS-Severity score \>=10

Exclusion Criteria:

* Subjects with pure anterocollis
* Subjects with neuromuscular junctional disorders (e.g., myasthenia gravis, Lambert-Eaton syndrome)
* A history of an anaphylactic response to Botulinum toxin type A and other involved ingredients of Investigational product
* Subjects of reproductive age who do not agree to use suitable contraceptive methods for the duration of the study

Primary outcomes:
measure: Change in Toronto Western Spasmodic Torticollis Rating Scale Total Score From Baseline
timeFrame: week 4 follow-up visit
Secondary outcomes:
measure: Toronto Western Spasmodic Torticollis Rating Scale Severity Subscale as a change From Baseline
timeFrame: week 4 follow-up visit
measure: Toronto Western Spasmodic Torticollis Rating Scale Disability Subscale as a change From Baseline
timeFrame: week 4 follow-up visit
measure: Toronto Western Spasmodic Torticollis Rating Scale Pain Subscale as a change From Baseline
timeFrame: week 4 follow-up visit
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
Study officials:
References:
Clinical trial NCT04755920: SGM-101 in Colorectal Brain Metastases.
Official title: A Feasibility Study of SGM-101, a Fluorochrome-labeled Anti-carcinoembryonic Antigen Monoclonal Antibody for the Intraoperative Detection of Colorectal Brain Metastases.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Rectal Neoplasms
Rectum Cancer
Colorectal Neoplasms
Brain Metastases
Brain Neoplasms
Brain Diseases
Brain Cancer
Brain Tumor
Intestinal Neoplasms
Gastrointestinal Neoplasms
Gastrointestinal Cancer
Gastrointestinal Disease
Intestinal Disease
Lead sponsor: Leiden University Medical Center
Sponsor class: OTHER
Collaborators: name: Medical Center Haaglanden
name: Surgimab
First posted: 2021-02-16
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: This study assesses the feasibility of SGM-101, a fluorochrome-labeled anti-carcinoembryonic antigen monoclonal antibody, for intraoperative near-infrared fluorescence imaging of colorectal brain metastases by injecting SGM-101 intravenously 3 - 5 days prior to surgery.


Eligibility criteria: Inclusion Criteria:

1. Signed informed consent prior to any study-mandated procedure;
2. Patients aged over 18 years old;
3. All women of child bearing potential and all males must practice effective contraception during the study and be willing and able to continue contraception for at least 30 days after their last dose of study treatment.
4. Has the ability to communicate well with the Investigator in the Dutch language and willing to comply with the study restrictions.
5. Diagnosed with brain metastasis of colorectal origin and scheduled for a resection.

Exclusion Criteria:

1. History of any anaphylactic reaction;
2. Previous use of SGM-101;
3. Other malignancies either currently active or diagnosed in the last 5 years, except adequately treated in situ carcinoma of the cervix and basal or squamous cell skin carcinoma;
4. Laboratory abnormalities defined as:

   1. Aspartate AminoTransferase, Alanine AminoTransferase, Gamma Glutamyl Transferase) or Alkaline Phosphatase levels above 5 times the or;
   2. Total bilirubin above 2 times the ULN or;
   3. Serum creatinine above 1.5 times the ULN or;
   4. Platelet count below 100 x 109/L or;
   5. Hemoglobin below 4 mmol/L (females) or below 5 mmol/l (males);
   6. Known positive test for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAG) or hepatitis C virus (HCV) antibody or patients with untreated serious infections;
5. Patients pregnant or breastfeeding;
6. Any condition that the investigator considers to be potentially jeopardizing the patient's well-being or the study objectives.

Primary outcomes:
measure: To determine the feasibility of SGM-101 for intraoperative imaging of colorectal brain metastases.
timeFrame: Intraoperative
Secondary outcomes:
Other outcomes:
Locations:
city: Leiden
country: Netherlands
facility: Leiden University Medical Center
city: The Hague
country: Netherlands
facility: Medical Center Haaglanden
Study officials:
References:
Clinical trial NCT02694120: Study on Complications, EfficAcy and Costs of Large Polypectomy
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Polypectomy
Lead sponsor: Valduce Hospital
Sponsor class: OTHER
First posted: 2016-02-29
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Population undergoing large endoscopic polypectomy

Brief summary: Colonoscopy has been shown to reduce the incidence and mortality of colorectal cancer, through the recognition and removal of pre-cancerous lesions, which in most cases evolve with a sequence that goes through formation of high-grade dysplasia (HGD).

The probability of HGD increases with the increase of the lesion of the polyp itself. Lesions\> 2 cm are present in 1% of colonoscopy screening. The resection of these lesions presents a greater technical difficulty and consequently a decrease in the efficiency. The rate of incomplete resection reported in the literature reaches 10% while that of recurrence / residual adenoma 16.4 / 31.7%.

The aim of the study SCALP is to evaluate the incidence of complications, efficacy and cost of endoscopic resection of colic lesions\> 2cm in a setting of clinical practice in an unselected population


Eligibility criteria: Inclusion Criteria:

* adult patients undergoing large endoscopic polypectomy

Exclusion Criteria:

* pregnancy
* incapacity to give informed consent

Primary outcomes:
measure: complications of large polypectomy
timeFrame: 15 days
Secondary outcomes:
measure: costs of large polypectomy
timeFrame: 15 days
measure: efficacy of large polypectomy
timeFrame: 6 months
Other outcomes:
Locations:
Study officials:
References:
citation: Amato A, Radaelli F, Correale L, Di Giulio E, Buda A, Cennamo V, Fuccio L, Devani M, Tarantino O, Fiori G, De Nucci G, De Bellis M, Hassan C, Repici A; Bowell Group. Intra-procedural and delayed bleeding after resection of large colorectal lesions: The SCALP study. United European Gastroenterol J. 2019 Dec;7(10):1361-1372. doi: 10.1177/2050640619874176. Epub 2019 Sep 23.