louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02197299: Improving Glycaemic Control With L-carnitine
Official title: Increasing Skeletal Muscle Carnitine Content to Improve Glycaemic Control in Type 2 Diabetes Mellitus
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Type 2 Diabetes
Lead sponsor: University of Nottingham
Sponsor class: OTHER
First posted: 2014-07-22
Enrollment: 24
Sex: MALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: A characteristic of Type 2 diabetes is a high blood glucose level, which is partly caused by the inability of insulin to stimulate glucose uptake into our muscles (insulin resistance). Insulin resistance can be caused by the accumulation of fat within muscle of overweight individuals. The aim of the present research is to test whether a novel nutritional intervention containing L-carnitine can increase the amount of carnitine within muscle of individuals recently diagnosed with Type 2 diabetes. Carnitine is essential for 'burning fat' within our muscles and it is hoped that increasing the amount of carnitine within muscle can increase fat burning, lower muscle fat, reverse insulin resistance and ultimately lower blood glucose levels and wellbeing. We also aim to investigate the cellular mechanisms underlying any observed effects in a hope to identify further targets to lower muscle fat.


Eligibility criteria: Inclusion Criteria:

* Body mass index (BMI) 27-37 kg/m2
* Male
* Age 18-60 years old
* Type 2 diabetes mellitus reasonably well controlled (HbA1c less than or equal to 58 mmol/mol) on diet therapy or metformin alone
* Not taking anti-diabetes medication other than metformin
* Understand verbal and/or written explanation of the study requirements

Exclusion Criteria:

* Malignancy (excluding localised basal and squamous cell skin cancer)
* Metabolic diseases (stable treated hypothyroidism allowed)
* Active cardiovascular disease (current angina, myocardial infarct, or coronary artery surgery/angioplasty within 12 months)
* Primary muscle disorders
* Cerebrovascular disease
* Neurological disease e.g. epilepsy, Parkinsons disease
* Active respiratory disease
* Active gastrointestinal or liver disease
* Renal impairment (eGFR \<60 ml/min)
* Clotting dysfunction
* Anti-diabetes medication other than metformin
* Other medications that may affect glucose tolerance (e.g. corticosteroids), muscle metabolism, or safety (e.g. anticoagulants)
* Any other conditions in addition to the above that the investigators consider may affect study measurements or safety

Primary outcomes:
measure: Skeletal muscle total carnitine content
timeFrame: up to 24 weeks of L-carnitine supplementation
Secondary outcomes:
Other outcomes:
Locations:
city: Nottingham
country: United Kingdom
facility: David Greenfield Human Physiology Unit, School of Life Sciences, The University of Nottingham
Study officials:
affiliation: The University of Nottingham
name: Francis B Stephens, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02643199: Automated Fetal Heart Echocardiography by Five-Dimensional Ultrasound in the Third Trimester of Pregnancy
Official title: Automated Fetal Heart Echocardiography by Five-Dimensional Ultrasound in the Third Trimester of Pregnancy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Fetal Heart Echocardiography by Five Dimensional Ultrasound
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2015-12-31
Enrollment: 90
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 38
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This is a Prospective pilot study that will be performed at the Fetal Care Unit at Ain Shams University Maternity Hospital.

Ninety pregnant women will be recruited from the Fetal Care Unit who will fulfill the inclusion criteria. They will be counseled to be included into the study.

Brief summary: The aim of the study to evaluate Five-Dimensional Ultrasound in automated assessment of the fetal heart from 20-36 weeks of gestation.

Detailed description: This is a Prospective pilot study that will be performed at the Fetal Care Unit at Ain Shams University Maternity Hospital.

90 pregnant women will be recruited from the Fetal Care Unit who will fulfill the inclusion criteria. They will be counseled to be included into the study.

All cases will be subjected to:

1. Full history taking including patient's age, parity, last menstrual period, estimated gestational age by dates, past history of medical disorders, clinical examinations (General and abdominal).
2. Two-Dimensional Ultrasound and Five-Dimensional Ultrasound will be done for all cases for assessment of fetal Heart.

   * 90 consecutive patients will undergo 2D fetal echocardiography by one observer
   * Then they will undergo blindly Five-Dimensional fetal echocardiography by another observer
   * The data collected will be compared to evaluate the accuracy of Five-Dimensional US in fetal heart assessment.

Eligibility criteria: Inclusion Criteria:

1. Singleton pregnancy.
2. Gestational age at 34-36 weeks as determined be date and last menstrual period.
3. Normal Amniotic Fluid Index.

Exclusion Criteria:

1. Multiple pregnancies.
2. Oligohydramnios or Polyhydramnios (AFI \> 95th percentile or \< 5th percentile).
3. Obese patient, BMI \> 30
4. Intrauterine growth restriction.
5. Fetal spine between the 11- and 1- O'clock positions due to possibility of shadowing from ribs or spine

Primary outcomes:
measure: Number of Satisfactory Fetal Echocardiography Views by Two-Dimensional Ultrasound
timeFrame: 20 - 36 weeks of gestation
Secondary outcomes:
measure: Number of Satisfactory Fetal Echocardiography Views by Five-Dimensional Ultrasound
timeFrame: 20 - 36 weeks of gestation
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04265599: Exploring Pathogenesis and Treatment of Hypercalcemia Caused by Intramuscular Injection of Paraffinoil
Official title: Hypercalcemia After Cosmetic Paraffin Oil Injections: Unravelling Etiology, Pathogenesis and Potential Treatments
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Hypercalcemia
Renal Injury
Paraffinoma
Lead sponsor: Herlev Hospital
Sponsor class: OTHER
First posted: 2020-02-11
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: General population

Brief summary: The aim of the study is to characterize paraffin oil induced granulomatous disease. We will investigate pathogenesis and natural history of paraffin disease. Subsequently, through further translational studies, we intend to identify novel treatments to be tested in future randomized clinical trials.


Eligibility criteria: Inclusion Criteria:

* previous intramuscular injection of paraffin or other oil

Exclusion Criteria:

* none

Primary outcomes:
measure: Number of patients with concentration of ionized calcium in plasma above normal range = Hypercalcemia
timeFrame: at first examination or developed during observation period until 2025
measure: Number of patients with concentration of parathyroid hormone PTH in plasma below normal range
timeFrame: at first examination or developed during observation period until 2025
Secondary outcomes:
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Herlev Hospital
Study officials:
References:
Clinical trial NCT06753799: The Effect of Education on Patient Care Outcomes in Individuals With Diabetic Foot Ulcer
Official title: The Effect of Education Based on Social Cognitive Learning Theory on Patient Participation, Self-Efficacy and Wound Healing in Individuals With Diabetic Foot Ulcer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Foot Ulcer, Diabetic
Patient Engagement
Self Efficacy
Wound Healing
Nursing
Keywords: Diabetic foot ulcer
patient participation
self-efficacy
wound healing
nursing
Lead sponsor: Saglik Bilimleri Universitesi Gulhane Tip Fakultesi
Sponsor class: OTHER
First posted: 2024-12-31
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The aim of this study is to determine the effect of Social Cognitive Learning Theory-based education on patient participation, self-efficacy and wound healing in individuals with diabetic foot ulcers. The research was conducted with 52 patients (25 intervention and 27 control) with Wagner 2 diabetic foot ulcers at Gülhane Training and Research Hospital between January and September 2024.

Detailed description: The study was conducted in four stages: first application to the clinic, 1st month, 2nd month and 3rd month. While the Social Cognitive Learning Theory was applied to the intervention group, only the currrent clinical education was provided to the control group. The research data were collected using the "Data Collection Form Regarding Participants' Identifying Characteristics", "Diabetic Foot Information Form", "Metabolic Status and Wound Follow-up Form", "Patient Participation Scale" and "Diabetic Foot Care Self-Efficacy Scale". The results of this study show that education based on Social Cognitive Learning Theory is effective on patient participation, self-efficacy and wound healing in individuals with diabetic foot ulcers.

Eligibility criteria: Inclusion Criteria:

* Individuals 18 years of age or older Agree to participate in the study Have type 2 diabetes Have a Wagner classification score of 2 Have the same wound care protocols (epidermal growth factor/hyalunoric acid containing cream and dressing with gauze)

Exclusion Criteria:

* Having communication difficulties and mental retardation Having vision and manual dexterity problems Having diabetic foot infection

Primary outcomes:
measure: Change in ulcer size
timeFrame: From enrollment to the end of treatment at 3 months
measure: Change in patient participation
timeFrame: From enrollment to the end of treatment at 3 months
measure: Change in self-efficacy
timeFrame: From enrollment to the end of treatment at 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: University of Health Sciences Gulhane Faculty of Nursing
Study officials:
affiliation: University of Health Sciences Gulhane Faculty of Nursing
name: Fadime Koyuncu, 2
role: STUDY_CHAIR
affiliation: Gulhane Training and Research Hospital
name: Kerim Bora YILMAZ, 3
role: STUDY_CHAIR
References:
Clinical trial NCT01929499: Efficacy of Adjuvant Cytokine-induced Killer Cells in Colon Cancer
Official title: Efficacy of Adjuvant Immunotherapy With Cytokine-induced Killer Cells in Patients With Stage II/III Colon Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Colonic Neoplasms
Keywords: Colon cancer
Cytokine-induced killer cells
Adjuvant immunotherapy
Adjuvant chemotherapy
Lead sponsor: Guangdong Provincial Hospital of Traditional Chinese Medicine
Sponsor class: OTHER
First posted: 2013-08-28
Enrollment: 210
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: It has been reported that the immune status of patients with cancer were suppressed, especially those after surgery and adjuvant chemotherapy. Thus, immunotherapy may decrease the recurrence rate after surgery. CIK cells transfusion has been reported as an effect therapy in advanced cancers. In another retrospective study, investigators found that adjuvant CIK therapy would prolong the disease-free survival (DFS) for colorectal cancer patients.

The purpose of this study is to determine wether adjuvant immunotherapy with CIK cells in patients with colon cancer after operation will prolong DFS, and overall survival (OS).


Eligibility criteria: Inclusion Criteria:

* Colon cancer in stage III or stage II with high risk after R0 resection
* Eastern Cooperative Oncology Group (ECOG) performance status was 0 - 1;
* Life expectancy of at least 3 months;
* Normal bone marrow, liver, renal, heart and lung function;
* Age between 18-80;
* Patients who provided written informed consent for this study

Exclusion Criteria:

* With uncontrolled other malignant tumors;
* With uncontrolled infection or tubercle bacillus (TB) or underlying diseases that were severe or life threatening;
* Patients who need to treat with radiotherapy;
* Patients who accepted other immunotherapy
* With sever mental disease or disease with central nervous system (CNS);
* With the history of organ transplantation, including bone marrow transplantation or stem cell transplantation;
* Patients with auto immune diseases;
* pregnant or lactating.

Primary outcomes:
measure: DFS (Disease free survival)
timeFrame: Time elapsedelapsed from the date of surgery to either the date of recurrence or the date of last follow-up information,whichever come first, assessed up to 5 years.
Secondary outcomes:
measure: OS (overall survival)
timeFrame: Time elapsed from the date of surgery to either the date of death or the date of last follow-up information, whichever came first, assessed up to 5 years.
measure: Side effect
timeFrame: Up to 2 years
measure: T lymphocyte subset
timeFrame: Up to 6 months
measure: QoL (quality of life)
timeFrame: Up to 1 year
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Guangdong Provincial Hospital of Chinese Medicine
state: Guangdong
Study officials:
affiliation: Guangdong Provincial Hospital of Chinese Medicine, China
name: Haibo Zhang, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02887599: Assessment of the Cytotoxic Immune Status of Pancreatic Cancer Patients and the Severity of the Cancer Using Measurement of Natural Killer Cell Activities
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pancreatic Cancer
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2016-09-02
Enrollment: 203
Sex: ALL
Minimum age (years): 19
Maximum age (years): 84
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: Pancreatic cancer is the 5th leading cause of cancer death and the worst prognostic cancer in the world. This is due to high recurrent rate after surgical resection and poor response to chemotherapy and radiotherapy.

Recent studies revealed that peri-tumoral structure and patients' immune status including cytotoxic immunity played significant role in the bad behavior of pancreatic cancer. While past studies focused on oncogenes and tumor suppressor genes, recent studies focused on patients' own immunity. Patients' immunity modified by cancer cells is found to be correlated to cancer progression and metastasis.

Natural killer cells, playing an important role in cytotoxic immune system, are revealed to be decreased in patients with lung cancer, ovarian cancer, prostate cancer, colorectal cancer, and breast cancer. And in melanoma mouse model, when NK cell was suppressed, cancer progression and metastasis were accelerated.

This study sought to find the correlation of patients' cytotoxic immune status to cancer progression and status by measurement of NK cell activity in pancreatic cancer patients. This would be basic support to construct a prognostic model of pancreatic cancer for early metastasis and post operational recurrence.


Eligibility criteria: Inclusion Criteria:

* age over 18 and under 85
* Control group : incidental found benign pancreatic cyst, non-neoplastic gall bladder polyp (ex, cholesterol polyp), healthy people having no evidence of malignancy in check up within 1 year
* Patient group : histological diagnosed pancreatic cancer patients, clinically diagnosed pancreatic cancer patients by radiologic evaluation
* Agreed to enroll the study and signed informed consent

Exclusion Criteria:

* Patients with other malignancies within 5 years
* Patients treated with steroid due to any reason within 1 year
* Not signed informed consent

Primary outcomes:
measure: Difference of the cytotoxic immune status
timeFrame: 24-hour after blood collection
measure: Difference of the severity of the pancreatic cancer
timeFrame: 24-hour after blood collection
Secondary outcomes:
measure: Correlation of the cytotoxic immune status
timeFrame: 24-hour after blood collection
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Severance Hospital, Yonsei University
Study officials:
References:
Clinical trial NCT03376399: Potential Benefits of Sleeve Gastrectomy Surgery on Diabetic Gastroparesis Symptoms
Official title: Do Sleeve Gastrectomies Result in Improved Gastric Emptying and Thus Improved Symptoms in Patients With Diabetic Gastroparesis?
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Weight Loss
Diabetic Gastroparesis
Bariatric Surgery Candidate
Sleeve Gastrectomy
Gastric Emptying
Keywords: Sleeve Gastrectomy
Gastric Emptying
Diabetic Gastroparesis
Bariatric Surgery Candidate
Lead sponsor: Baylor Research Institute
Sponsor class: OTHER
First posted: 2017-12-18
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study group will be patients with diabetic gastroparesis who qualify for bariatric weight loss surgery (BMI \>35, insurance/medicare bariatric coverage). These patients are referred by gastroenterologists and/or endocrinologists with established diagnosis of diabetic gastroparesis confirmed via delayed gastric emptying on scintigraphy. All available treatment options will be discussed with every qualifying patient. Patients opting for sleeve gastrectomy will be invited to participate in the registry.

Brief summary: The purpose of this registry is to evaluate if sleeve gastrectomy surgery will help with symptoms of delayed gastric emptying for patients suffering from diabetic gastroparesis.

Detailed description: This is a prospective registry enrolling patients with an established diagnosis of diabetic gastroparesis and interested in receiving a sleeve gastrectomy for weight loss. An often intentional outcome of sleeve gastrectomy is an increase in gastric emptying. The relationship between how beneficial this outcome could be for diabetic gastroparesis patients suffering from delayed gastric emptying is not very well established. The purpose of this study is to find out if sleeve gastrectomy surgery will also help with symptoms of delayed gastric emptying. This study involves completing the Gastroparesis Cardinal Symptom Index questionnaire before your weight loss surgery and after surgery at the following time points; 30 days, 3 months, 6 months, and 12 months.

Eligibility criteria: Inclusion Criteria:

* Age 18 years and above
* BMI \> 35
* Diagnosis of diabetic gastroparesis as confirmed via scintigraphy
* Subject opting to undergo sleeve gastrectomy

Exclusion Criteria:

- Any previous weight loss surgery or prior gastrectomies

Primary outcomes:
measure: Examine gastroparesis symptoms
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Dallas
country: United States
facility: Baylor Weight Loss Surgery Center
state: Texas
Study officials:
affiliation: Baylor Scott & White, Baylor University Medical Center
name: Daniel Davis, DO
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02400099: Protein-rich Diet and NAFLD in Bariatric Surgery
Official title: Protein-rich Diet and Non-Alcoholic Fatty Liver Disease in Bariatric Surgery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Obesity
Non-alcoholic Fatty Liver Disease
Lead sponsor: Catholic University of the Sacred Heart
Sponsor class: OTHER
Collaborators: name: Federico II University
First posted: 2015-03-26
Enrollment: 60
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: Randomized, single-blind, trial to determine whether a high-protein, low calorie diet is more effective than a control low calorie diet in improving the metabolic and histologic abnormalities in patients with Non-alcoholic Fatty Liver Disease undergoing bariatric surgery.


Eligibility criteria: Inclusion Criteria:

* Morbidly obese subjects with a BMI \>40 kg/m2 who are eligible for bariatric surgery and have accepted to undergo RYGB
* Weight stable for at least 6 months before the study (+/- 5 kg within the previous 6 months)
* Stable medication
* Provision of informed consent

Exclusion Criteria:

* Patients not eligible for laparoscopic RYGB
* Incapacity to give a valid informed consent or unwilling to give the consent
* Pregnancy or lactating
* Type 2-diabetes mellitus
* Significant illness within the two weeks preceding surgery, as judged by the physician.
* Obvious infection (bacteria, virus etc)
* Major cardiovascular disease
* Major gastrointestinal, respiratory, or any hormonal disorders
* History of drug addiction and/or alcohol use
* Suspected or confirmed poor compliance
* Alcohol consumption of \> 20 g per day in the case of women and \> 30 g per day in the case of men for at least 3 consecutive months during the previous 5 years
* Presence of hepatitis C or frank cirrhosis.

Primary outcomes:
measure: Liver fat content assessment
timeFrame: 1 year
Secondary outcomes:
measure: Insulin sensitivity assessment
timeFrame: 1 year
measure: fat free mass assessment
timeFrame: 1 year
Other outcomes:
Locations:
city: Rome
country: Italy
facility: Catholic University School of Medicine
Study officials:
References:
Clinical trial NCT04247399: Simulation-assisted Teaching in Learning Gastroscopy
Official title: Simulation-assisted Teaching in Learning Gastroscopy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Endoscopy
Education
Gastroscopy
Esophagogastroduodenoscopy
Simulation
Lead sponsor: Odense University Hospital
Sponsor class: OTHER
First posted: 2020-01-30
Enrollment: 25
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This project is a single-blinded randomized controlled trial investigating the effect of simulation-based teaching in learning gastroscopy for medical doctors.


Eligibility criteria: Inclusion Criteria:

* Medical doctors in medical gastroenterology or surgery

Exclusion Criteria:

* prior experience with gastroscopy

Primary outcomes:
measure: Number of procedures before declared unassisted
timeFrame: 1 year
Secondary outcomes:
measure: Patient satisfaction
timeFrame: 1 year
measure: Complication rate
timeFrame: 1 year
measure: Mucosa visualization percent of the upper gastrointestinal tract
timeFrame: 1 year
measure: Duration of intubation
timeFrame: 1 year
measure: Time
timeFrame: 1 year
Other outcomes:
Locations:
city: Odense
country: Denmark
facility: Odense University Hospital
state: Region Of Southern Denmark
Study officials:
affiliation: Odense University Hospital
name: Anders Bo Nielsen, MD
role: PRINCIPAL_INVESTIGATOR
References: