louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05707520: Long-term Benefit of MPA in Liver Transplantation
Official title: Clinical Evaluation of the Long-term Benefit of Enteric-coated Mycophenolate (MPAs) After Liver Transplantation
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Liver Transplant Rejection
Immunosuppressant Adverse Reaction
Keywords: enteric-coated mycophenolate
adverse reaction
liver transplantation
transplant rejection
Lead sponsor: Third Affiliated Hospital, Sun Yat-Sen University
Sponsor class: OTHER
Collaborators: name: Shulan (Hangzhou) Hospital
name: RenJi Hospital
name: The First Affiliated Hospital of Zhengzhou University
name: Beijing YouAn Hospital
name: Huashan Hospital
name: The Third Xiangya Hospital of Central South University
name: West China Hospital
name: Hebei Medical University Third Hospital
name: People's Hospital of Guangxi Zhuang Autonomous Region
name: Beijing Friendship Hospital
name: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
First posted: 2023-02-01
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Long-term survived liver transplant recipients in 13 hospitals in China

Brief summary: MPA drugs are antiproliferative immunosuppressants and are widely used in solid organ transplantation. MPA drugs do not affect the recipient's kidney function and do not cause metabolic abnormalities and other problems. Intestinal solvent-based MPA drugs are widely used in clinical practice by improving the dosage form, reducing the irritation of MPA to the mucosa of the digestive tract, improving the tolerability of patients and maintaining a sufficient amount of MPA. However, data on the use/long-term use of intestinal solvent-based MPAs in liver transplant recipients are lacking. The study aims to evaluate the long-term benefits of enteric-coated mycophenolic acid in liver transplant recipients.


Eligibility criteria: Inclusion Criteria:

* Patients who underwent their first liver transplantation between January 1, 2016 and February 28, 2021;
* Recipient's survival time≥ 1 year;
* Age 18\~65 years old;
* Patients with complete data and no loss to follow-up.

Exclusion Criteria:

* use of other types of anti-metabolic immunosuppressants;
* Second liver transplantation for various reasons within 1 year after the first transplantation;
* Patients with serious underlying diseases, including heart disease, infection and renal insufficiency, combined with other malignant tumors.

Primary outcomes:
measure: complex endpoint
timeFrame: 60 months after liver transplantation
Secondary outcomes:
measure: Late onset acute rejection
timeFrame: 60 months after liver transplantation
measure: Incidence of AKI or CKD
timeFrame: 60 months after liver transplantation
measure: Adverse events
timeFrame: 60 months after liver transplantation
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Third Affiliated Hospital, Sun Yat-Sen University
state: Guangdong
Study officials:
References:
Clinical trial NCT00491920: High Dosage Vitamin D and Osteoporosis
Official title: High Dosage Vitamin D in the Treatment of Osteoporosis in Postmenopausal Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Osteoporosis
Osteopenia
Keywords: osteoporosis
bone mineral density
vitamin D
Lead sponsor: University Hospital of North Norway
Sponsor class: OTHER
Collaborators: name: Norske Kvinners Sanitetsforening Troms
First posted: 2007-06-26
Enrollment: 297
Sex: FEMALE
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Vitamin D and calcium are essential in the treatment and prevention of osteoporosis. What dosage of vitamin D which is the ideal one, is not yet clear. We want to test the hypothesis that high dosage of vitamin D (i.e. 6500 IU/d) is better than standard dosage (800 IU/d) in a randomized double-blind trial. We will include 400 postmenopausal otherwise healthy women with T-score \<= -2.0 in L2-4 or mean total hip. Everybody will receive calcium 1000 mg and vitamin D 800 IU every day. Half of the group will also receive vitamin D 40 000 IU/week, while the other half will have placebo. The study period is one year.


Eligibility criteria: Inclusion Criteria:

* bone mineral density in L2-4 or mean total hip with T-score \<= -2.0

Exclusion Criteria:

* current use of bisphosphonates, PTH-analogs, estrogen, SERM, p.o. steroids or use of any of these agents last year
* serum creatinin \>110 umol/L
* systolic blood pressure \>175 mmHg or diastolic blod pressure \>105
* serious disease (heart failure, angina pectoris, myocardial infarction, diabetes, mental reduction, granulomatous disease like sarcoidosis, cancer)
* kidney stone
* serum calcium \> 2.55 mmol/L
* suspect primary hyperparathyroidism with serum calcium \>2.50 mmol/L combined with PTH \> 5.0 mmol/L or serum calcium \> 2.45 mmol/L combined with PTH \>= 7.0 pmol/L

Primary outcomes:
measure: changes in bone mineral density in columna and total hip.
timeFrame: One year
Secondary outcomes:
measure: Muscle strength (hand grip strength and knee extension)
timeFrame: One year
measure: balance (tandem test)
timeFrame: One year
measure: body composition (Dexa)
timeFrame: One year
measure: inflammation markers
timeFrame: One year
measure: calcium and vitamin D metabolism
timeFrame: One year
measure: blood lipids
timeFrame: One year
measure: renal function
timeFrame: One year
measure: telomere length
timeFrame: one year
measure: perception of own health
timeFrame: one year
measure: Urinary tract symptoms
timeFrame: one year
measure: effects of polymorphisms in VDR on the other endpoints
timeFrame: one year
measure: side effects
timeFrame: one year
Other outcomes:
Locations:
city: Tromsø
country: Norway
facility: Medical Dpt. B, University Hospital of Northern Norway
Study officials:
affiliation: Medical Dpt, University Hospital of Northern Norway
name: Rolf Jorde, Ph.D, M.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05434520: Relieving the Bile Ducts Prior to Pancreatoduodenectomy
Official title: Relieving the Bile Ducts Prior to Pancreatoduodenectomy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pancreas Cancer
Surgery-Complications
Biliary Fistula
Keywords: pancreatoduodenectomy
complications
percutaneous transhepatic biliary drainage
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
First posted: 2022-06-28
Enrollment: 722
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients who had undergone pancreatoduodenectomy from January 1st, 2015 to September 31, 2021

Brief summary: The aim of this study was to assess the risk and complications after preoperative drainage of biliary obstruction in patients who underwent pancreatoduodenectomy.

A retrospective cohort study of all patients who underwent pancreatoduodenectomy from January 1st, 2015 to September 30th, 2021. Patients who had preoperative bile duct drainage were compared to patients without intervention. Type of interventions, complications and outcome after surgery were compared using univariate and multivariate analysis.

Detailed description: Obstructive jaundice is a common problem in pancreatic and periampullary tumors, but preoperative biliary drainage in patients with hyperbilirubinemia is still controversial. The aim of this retrospective cohort study was to assess the risk and complications after preoperative drainage of biliary obstruction in patients who underwent pancreatoduodenectomy.

A retrospective cohort study of all patients who underwent pancreatoduodenectomy from January 1st, 2015 to September 30th, 2021.

Eligibility criteria: Inclusion Criteria:

* All patients who had undergone pancreatoduodenectomy

Exclusion Criteria:

* None

Primary outcomes:
measure: Post-operative complication score (Clavien-Dindo)
timeFrame: During hospital admission, median time 13 days, up to 390 days.
measure: 30-day Mortality
timeFrame: up to 30 days
measure: 90-day Mortality
timeFrame: up to 90 days
measure: Length of Hospital Stay
timeFrame: Days from admission until discharge, up to 390 days, median time 13 days
measure: 30-day Readmission
timeFrame: up to 30-days from hospital discharge
Secondary outcomes:
measure: Complications following preoperative bile duct drainage
timeFrame: up to 7 days after bile duct drainage
measure: Time from Bile Duct Drainage to Pancreatoduodenectomy
timeFrame: Days from bile duct decompression to pancreatoduodenectomy, median time 32 days, up to 534 days
measure: Histological Specimen
timeFrame: Obtained within 21 days after resection
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Rigshospitalet
state: Capitol
Study officials:
References:
Clinical trial NCT01083420: The Efficacy of Topical Minocycline in Managing Symptomatic Oral Lichen Planus
Official title: The Efficacy of Topical Minocycline in Managing Symptomatic Oral Lichen Planus. A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Oral Lichen Planus
Keywords: Oral lichen planus
Minocycline
Dexamethasone
Lead sponsor: Sheba Medical Center
Sponsor class: OTHER_GOV
First posted: 2010-03-09
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The aim of the present study is to assess the clinical efficacy of topical minocyclin in managing of symptoms associated with oral lichen planus (OLP). The rationale of the study is based on our previous studies demonstrating the beneficial effect of minocyclin mouthwash on recurrent aphthous stomatitis. The planned study will be a randomized controlled, cross-over trail. Patients with symptomatic OLP will randomly receive minocycline or dexamethasone rinses.

The patients will rinse and expectorate 5 ml of the 1st mouthwash 4 times daily for 14 days. Subjects will complete a daily follow-up form that includes data regarding the daily intensity of pain (using VAS) caused by OLP and regarding possible side effects. After a washout period (at least 14 days) the patients will repeat the protocol with the second mouthwash.


Eligibility criteria: Inclusion Criteria:

* OLP patients (Biopsy proven)

Exclusion Criteria:

* Known allergy to Dexamethasone or Minocycline
* Pregnancy

Primary outcomes:
measure: symptoms relief
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Sheba Medical Center
name: Noam Yarom, DMD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00632320: Continuous Positive Airway Pressure and Oxygen Concentration on Measurement of Rapid Shallow Breathing Index
Official title: Effect of Continuous Positive Airway Pressure and Oxygen Concentration on Measurement of Rapid Shallow Breathing Index
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Respiratory Failure
Keywords: Ventilator, mechanical
Ventilator weaning
Rapid shallow breathing index
Continuous positive airway pressure
Receiver operating characteristic curve
COPD
Lead sponsor: Taipei Veterans General Hospital, Taiwan
Sponsor class: OTHER_GOV
First posted: 2008-03-10
Enrollment: 98
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: respiratory therapy intensive Care unit in a medical center

Brief summary: To compare the rapid shallow breathing index (RSBI) values, the incidence of adverse reactions, and the predictive accuracy measured under 5 different ventilator strategies in the same patient group.

Detailed description: 98 ready for weaning patients were included and divided into success (n=71) and failure (n=27) groups based upon their weaning outcome. Before weaning, the RSBI values were determined under the patients disconnecting from the ventilator (RA-no ventilator) and still connecting to the ventilator with 4 different settings (fraction of inspired oxygen (FiO2) 21 or 40% combined with continuous positive airway pressure (CPAP) 0 or 5 cm H2O). The patients were extubated after completing the weaning trials. Successful weaning was defined as patients free from the ventilator for over 48 hours.

Eligibility criteria: Inclusion Criteria:

* intubated medical patients with mechanically ventilated more than 48 hours
* clinically ready for weaning
* Glasgow coma scales were at least 8
* their ventilator settings were: assist-controlled, pressure support (PS)or synchronized intermittent mandatory ventilation plus PS mode, FiO2 40% or less, positive end-expiratory pressure 5 cm H2O or less, and sensitivity setting on 1 L/min. Their arterial blood gases results were acceptable

Exclusion Criteria:

* having ongoing lung or neuromuscular disease and signs of increased intracranial pressure

Primary outcomes:
measure: The patients connecting or disconnecting to the ventilators affected the RSBI values but not their predictive accuracies.
timeFrame: Before the patient processing weaning trials
Secondary outcomes:
measure: Changes in FiO2 and CPAP settings have no effect on RSBI values but ventilator methods with FiO2 21% have higher incidence of adverse reactions.
timeFrame: Before the patient processing weaning trials
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Respiratory Therapy Intensive Care Unit, Taipei Veterans General Hospital
Study officials:
affiliation: School of Respiratory Therapy, Taipei Medical University, Taipei, Taiwan, ROC
name: Mauo-Ying Bien, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02337920: Prediction of Femoral Revascularization Quality Using the Somatic NIRS Signal
Official title: Prediction of Femoral Revascularization Quality Using the Somatic NIRS Signal
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lower Limb Vascular Surgery - Femoral Artery Endarteriectomy
Lead sponsor: University Hospital, Caen
Sponsor class: OTHER
First posted: 2015-01-14
Enrollment: 31
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients undergoing unilateral femoral endarteriectomy

Brief summary: Despite effective femoral artery endarteriectomy, patients with occlusive arteritis may need complementary stenting of revascularization procedures within the 2 years after the primary surgery because of a poor blood supply in their lower limb extremity. The Near infrared spectrophotometry (NIRS) is a non-invasive monitoring of the brain or tissue oxygenation and provide information on the quality of the local oxygen supply. The aim of our observational study is to correlate the intraoperative NIRS variations at the calf and the soles and the one-year evolution of the arteritis.


Eligibility criteria: Inclusion Criteria:

* Patients undergoing unilateral femoral endarteriectomy

Exclusion Criteria:

* emergency surgery, allergy to adhesive glues, skin abnormalities of the operated leg, multiple associated revascularization procedures other than endarteriectomy

Primary outcomes:
measure: Relationship between the Maximum NIRS difference before and during the femoral artery clamping and the increase of walking perimeter
timeFrame: Change - One month, six months and one year after the surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Caen
country: France
facility: Caen University Hospital
state: Calvados
Study officials:
affiliation: University Hospital, Caen
name: Georges Daccache, M.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05312320: Improving Sexual Function After Myocardial Infarction
Official title: Improving Sexual Function After Myocardial Infarction - a Randomized Controlled Trial.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Sexual Function Disturbances
Myocardial Infarction
Lead sponsor: Sorlandet Hospital HF
Sponsor class: OTHER_GOV
Collaborators: name: Oslo University Hospital
First posted: 2022-04-05
Enrollment: 1200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 110
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The study is completely digital. Men and women who recently had an MI will be invited through a written brochure that will be present in all Norwegian departments of cardiology. Post-MI patients can check the investigators web site (www.sefh.no) to determine whether they are eligible for the study. After consent and answering the baseline questionnaire, each participant will be randomized to either the intervention or control group.

Control group: Standard surveillance after MI (no specific focus on sexual activity and functioning) Intervention group: Online sexual counselling including a short information film.

In order to assess the generalizability of the results, we will compare the age, sex and MI treatment of the respondents with data on Norwegian MI-patients in general.

Detailed description: The investigators will include 600 women and 600 men within 4 weeks after an acute MI. The investigators will invite the same number of women and men from the general population, invited through mass and social media.

All participants will be provided the same questionnaire at 4 weeks. Then outcome data will be obtained by a follow-up quest after 6 and 12 months.

The intervention is a film with the following main message:

* Sexual activity after MI does not increase risk of recurrence or death
* Sexual activity is associated with improved outcome after MI
* Resuming sexual activity as normal is recommended and completely safe

Eligibility criteria: Inclusion Criteria:

* Men and women ≥18 years old
* Acute MI during the last 6 weeks
* Informed consent for participation

Exclusion Criteria:

* Lack of ability to cooperate
* Known alcohol- or drug-abuse, or use of narcotics
* Pregnancy or breast-feeding
* Serious comorbidity with a life expectancy \<12 months
* Unstable or refractory angina
* Uncontrolled hypertension
* Congestive heart failure (NYHA class III/IV)
* High-risk arrhythmias
* Hypertrophic obstructive and other cardiomyopathies
* Severe valvular disease

Primary outcomes:
measure: Does specific sexual counselling improve sexual functioning in post-MI?
timeFrame: 12 months
measure: Changes in sexual activity and functioning after MI
timeFrame: 12 months
measure: Establish predictors of improved sexual functioning in post-MI patients
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Arendal
country: Norway
facility: Www.Sefh.No
Study officials:
affiliation: Sorlandets hospital HF
name: Frode Gallefoss
role: STUDY_DIRECTOR
References:
Clinical trial NCT00966420: Traction Assisted Polypectomy of the Intestine
Official title: Traction Assisted Endoscopic Mucosa Resection (TAEMR)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colonic Polyps
Adenomatous Polyps
Lead sponsor: St John of God Hospital, Vienna
Sponsor class: OTHER
First posted: 2009-08-27
Enrollment: 7
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to verify if the ablation of lesions (polyps, adenomas) in the large (and small) intestine can be facilitated by using a traction on the lesions.

Detailed description: We want to facilitate the ablation of lesions (polyps, adenomas) in the large (and small) intestine by using a traction assisted technique.

The traction will be performed by using a haemoclip connected to surgical suture materials. The haemoclip will be fixed to the intestinal mucosa next to the lesion and a loop will be mounted to perform an endoscopic mucosal resection.

The aim of the study is to show the feasibility of this technique.

Eligibility criteria: Inclusion Criteria:

* benign lesions in the large and small intestine
* diameter of lesion smaller than 3cm

Exclusion Criteria:

* malign lesions of the large and small intestine
* diameter of lesions larger than 3cm

Primary outcomes:
measure: ablation of lesion in toto
timeFrame: 1 week after intervention
Secondary outcomes:
measure: complications after resection
timeFrame: within one week after intervention
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Departement of Surgery, St John of God Hospital
Study officials:
affiliation: St John of God Hospital, Vienna
name: Bernhard Dauser, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06841120: Reversal of Anaesthesia with Diode Laser
Official title: Evaluation of Photobiomodulation Therapy with Diode Laser in Reversal of Maxillary and Mandibular Soft Tissue Local Anaesthesia in Paediatric Dentistry: Randomized Clinical Trial:a Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Photobiomodulation Therapy
Keywords: photobiomodulation therapy
diode laser
dental local anaesthesia
child
Lead sponsor: Recep Tayyip Erdogan University
Sponsor class: OTHER
First posted: 2025-02-24
Enrollment: 40
Sex: ALL
Minimum age (years): 4
Maximum age (years): 9
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Background: After local anesthesia, which is frequently used in pediatric dentistry, long-term soft tissue numbness can cause various problems. The aim of this study was to evaluate the effectiveness of PBMT in reversing soft tissue anaesthesia in children following local anaesthesia administration.

Methods: In a split-mouth randomized study, 40 children aged 4 to 9 years, eligible to receive local infiltration injection on both maxillary (n=20) and mandibular (n=20) right and left sides, will included. Maxillary and mandibular quadrants will be randomly assigned to laser or sham laser groups. Normality will assessed using the Kolmogorov-Smirnov test. Categorical variables between laser and control groups will compared using the McNemar paired sample test. Significance will be set at p\<0.05.


Eligibility criteria: Inclusion Criteria:

* - Children whose parents signed the written informed consent form and who themselves gave assent,
* Children with a Frankl behaviour rating scale score of 3 or 4,
* Children aged between 4 and 9 years old who can understand soft tissue sensation and respond to it,
* Children requiring treatment with local infiltration anaesthesia for multiple teeth in both the mandible and maxilla,
* Children with no history of allergy to materials used for anaesthesia or sulphite,
* Children who have not taken any analgesic medication at least 24 hours before treatment,
* Children without any systemic conditions that would interfere with dental treatment under local anaesthesia.

Exclusion Criteria:

* Occurrence of an error during anaesthesia injection resulting in insufficient anaesthesia for treatment,
* Inability of the patient to provide clear assessments of response to soft tissue anaesthesia,
* Presence of systemic conditions that would prevent anaesthesia administration or dental treatment,
* Children requiring urgent dental treatment priority such as acute painful teeth.

Primary outcomes:
measure: Anesthesia reversal time
timeFrame: up to 30 minutes after procedure
Secondary outcomes:
Other outcomes:
Locations:
city: Rize
country: Turkey
facility: Recep Tayyip Erdoğan University, Faculty of Dentistry
Study officials:
References: