louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06729944: Diagnostic Value of Next-Generation Sequencing Analysis in Biliary Tract Tumours
Official title: Diagnostic Value of Next-Generation Sequencing Analysis in Biliary Tract Tumours
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hepatectomy
NGS
Stenosis of Bile Duct
Keywords: Next Generation Sequencing
Stenosis of bile duct
Lead sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna
Sponsor class: OTHER
First posted: 2024-12-12
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: The patients' biological sample will be analysed by NGS and the results obtained will be compared with the morphological data
Primary purpose: DIAGNOSTIC

Brief summary: The aim of this study is to identify a dysplasia- and CCA-specific NGS panel to increase the diagnostic sensitivity of histological and/or cytological examination of biliary tract stenosis.

Detailed description: Patients undergoing biliary tract resection, as part of the normal course of care, at the O.U. General Surgery and Transplantation will be enrolled. Tissue samples will be processed and analysed at the O.U. of Pathological Anatomy.

Clinical, serological and instrumental data from patients, considered necessary for the intended analyses, will be collected for the purposes of the study.

The study will have a total duration of 36 months. It is planned to enrol 50 patients, all belonging to the U.O. Hepatobiliary and Transplant Surgery of the IRCCS Azienda Ospedaliero-Universitaria di Bologna. The size of the population is estimated on the basis of the number of cases/year from the U.O. Hepatobiliary and Transplant Surgery, and is considered sufficient to achieve the primary objective, since it is an exploratory study. Surgical material (resection of biliary tract, possibly hepatectomy or duodenocephalopancreasectomy), which will be sampled according to clinical practice and sent to the O.U. of Pathological Anatomy of the IRCCS AOUBO, where it will be sampled, fixed in formalin, included in paraffin and processed. From paraffin blocks (selected from those obtained from the sampling of surgical pieces according to clinical practice) 2 µm sections will be cut for Next Generation Sequencing investigations.

Eligibility criteria: Inclusion Criteria:

* Availability of enough tissue for histological and NGS analysis (at least 20 ng DNA).
* Age greater than/equal to 18 years.

Exclusion Criteria:

* None

Primary outcomes:
measure: Identification of an NGS panel specific to dysplasia and CCA
timeFrame: During enrollment period, up to 30 months
Secondary outcomes:
Other outcomes:
Locations:
city: Bologna
country: Italy
facility: IRCCS Azienda Ospedaliero-Universitaria di Bologna
Study officials:
affiliation: IRCCS Azienda Ospedaliero-Universitaria di Bologna
name: Francesco Vasuri, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06997744: TENS for Limb Function in Stroke: Design and Rationale for a Randomized Trial
Official title: Comparative Effects of 2Hz Versus 100Hz Transcutaneous Electrical Nerve Stimulation on Upper Limb Motor Function Post-Stroke: Design and Rationale for a Randomized Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Stroke
Lead sponsor: Shenzhen Baoan District Fuyong People's Hospital
Sponsor class: OTHER
First posted: 2025-05-30
Enrollment: 156
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: This study tests whether slow or fast electrical nerve stimulation (TENS) works better to improve arm movement in people recovering from a stroke. Participants will receive TENS on their weak arm three times a week for eight weeks. The results will help find the best TENS setting to support stroke recovery.


Eligibility criteria: Inclusion Criteria:

1. Age 18 to 85 years
2. Clinical diagnosis of stroke (ischemic or hemorrhagic) within the past 10 days to 2 months
3. Presence of voluntary movement in the non-paretic arm and at least minimal antigravity movement in the paretic shoulder
4. At least 5 degrees of active wrist extension on the paretic side
5. Able to provide informed consent

Exclusion Criteria:

1. Uncontrolled medical, cardiovascular, or orthopedic conditions
2. Contraindications to TENS (e.g., implanted cardiac pacemaker, skin allergies)
3. Receptive aphasia preventing informed consent or cooperation
4. Significant peripheral neuropathy affecting upper limbs
5. Current participation in another clinical trial or drug study
6. Severe contractures in the shoulder, elbow, wrist, or fingers

Primary outcomes:
measure: Fugl-Meyer Assessment for Upper Extremity (FMA-UE)
timeFrame: Baseline, Week 4, Week 8, 1-month follow-up, and 3-month follow-up
Secondary outcomes:
measure: Manual Muscle Testing (MMT) for Wrist Flexion and Extension
timeFrame: Baseline, Week 4, Week 8, 1-month follow-up, 3-month follow-up
measure: Modified Ashworth Scale (MAS) for Wrist Flexor Spasticity
timeFrame: Baseline, Week 4, Week 8, 1-month follow-up, 3-month follow-up
measure: Lindmark Motor Score - Grasp Function Subscale
timeFrame: Baseline, Week 4, Week 8, 1-month follow-up, 3-month follow-up
measure: Barthel Index
timeFrame: Baseline, Week 4, Week 8, 1-month follow-up, 3-month follow-up
Other outcomes:
Locations:
city: Shenzhen
country: China
facility: Fuyong People's Hospital, Bao'an District, Shenzhen
state: Guangdong
Study officials:
References:
Clinical trial NCT02809144: A Novel Combination of Peripheral Nerve Blocks for Patients Scheduled for Shoulder Surgery
Official title: A Novel Combination of Peripheral Nerve Blocks for Patients Scheduled for Shoulder Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain
Lead sponsor: University Hospital of North Norway
Sponsor class: OTHER
First posted: 2016-06-22
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Interscalene block has been the traditional regional anesthesia for shoulder surgery and postoperative pain. However, the risk of phrenic nerve palsy and irreversible nerve injury have encouraged search for alternative methods.

Detailed description: Analyzing block effects of the lateral sagittal infraclavicular brachial plexus block(posterior and lateral chord), the investigators found it affecting all shoulder relevant nerves , except for the suprascapular and the supraclavicular nerves.

Accordingly, by combining a superficial cervical plexus block, suprascapular nerve block and block of the posterior and lateral chords infraclavicularly, the investigators believe this novel combination would provide anesthesia for patients scheduled for shoulder surgery.

Eligibility criteria: Inclusion Criteria:

* Patients scheduled for shoulder surgery.
* American Society of Anesthesiologist grad I-III,
* 18-70 years,
* BMI 20-35,

Exclusion Criteria:

* Pregnancy,
* coagulopathy,
* allergy to local anesthetics,
* atrioventricular block,
* peripheral neuropathy or drug-treated diabetes.
* Patients using anticoagulation other than acetylsalicylic acid or dipyridamol will be excluded.

Primary outcomes:
measure: The need for general anaesthesia
timeFrame: Intraoperatively
Secondary outcomes:
measure: Surgeons satisfaction with the working conditions
timeFrame: Intraoperatively
Other outcomes:
Locations:
city: Tromsø
country: Norway
facility: University Hospital of North Norway
state: Troms
Study officials:
affiliation: University Hospital of North Norway
name: Lars Marius Ytrebø, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02673944: Portable Pves Study
Official title: An Accuracy Study to Assess the Performance of the Peritron+ in Measuring Vesical Pressure in Patients in Comparison With Standard Urodynamic Measurements
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lower Urinary Tract Symptoms
Lead sponsor: Laborie Medical Technologies Inc.
Sponsor class: INDUSTRY
First posted: 2016-02-04
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP

Brief summary: A comparative study will be conducted and the patient will undergo a conventional urodynamic study. In order to successfully determine if the Peritron+ is capturing vesical pressure measurements consistent with conventional urodynamics the two sources of Pves will be collected concurrently.


Eligibility criteria: Inclusion Criteria:

* Patients normally indicated for urodynamic evaluation

Exclusion Criteria:

* Patients who suffer from bladder infections
* Patients who suffer from strictures in the urethra

Primary outcomes:
measure: Accurate Vesical PRessure
timeFrame: During a routine urodynamic study (1 hr approx)
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01864044: Prospective Observational Lymphoedema Intensive Treatment
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lymphoedema
Lead sponsor: Thuasne
Sponsor class: INDUSTRY
First posted: 2013-05-29
Enrollment: 306
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All consecutive adult patients hospitalized with a clinical diagnosis of unilateral stage II-III upper or lower limb lymphoedema of any etiology and an indication for intensive decongestive therapy (IDT) were enrolled.

Brief summary: The aim of this observational study was to describe usual practices in lymphedema management in France.

It was the opportunity to assess the effects of these practices on lymphedema volume in a large number of patients, to identify predictive factors of response, and to assess the safety of this therapy.

Detailed description: Lymphoedema is commonly treated according a strategy called Complex Decongestive Therapy (CDT). This CDT is usually composed of 2 different treatment phases. The first phase is an acute phase which aim is to reduce affected limb volume. The second phase is a maintenance phase which aim is to maintain as long as possible the volume reduction acheived during the first phase.

These 2 phases required multi modal parameters such as bandages, lymphatic drainages, physical exercises...and can be managed very differently from one site to another.

Eligibility criteria: Inclusion Criteria:

* consecutive adult patients
* hospitalized with a clinical diagnosis of unilateral stage II-III upper or lower limb lymphoedema of any etiology
* indication for intensive decongestive therapy (IDT)

Exclusion Criteria:

* bilateral lymphedema,
* lymphedema of both upper and lower limbs,
* intensive decongestive therapy in the previous 6 months,
* cancer recurrence,
* systolic pressure index \< 0.5

Primary outcomes:
measure: Change from baseline in affected limb volume
timeFrame: At the end of 1st phase of Complex Decongestive Therapy and 6 months later
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05699044: Screening of ATTRwt in Patient With Advanced AV-Block Undergoing Pacemaker Implantation
Official title: Prevalence, Characteristics and Prognosis of Transthyretin Amyloidosis in Patients With New-onset Advanced AV-block - A National Screening Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Amyloid Cardiomyopathy
Block, AV
Lead sponsor: Aarhus University Hospital Skejby
Sponsor class: OTHER
First posted: 2023-01-26
Enrollment: 170
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients admitted for pacemakerimplantation with advanced AV-block fulfilling eligibility criteria as described.

Brief summary: The investigators will nationally investigate the prevalence of Transthyretin Amyloidosis wildtype (ATTRwt) in patients of ≥ 65 years with left ventricular hypertrophy who present with high degree atrioventricular block (AV-block) and are admitted for pacemaker implantation. The investigators aim to characterize the group of patients with positive screening of ATTR and compare the ATTRwt disease stage at time of diagnosis for patients identified with ATTR at screening with a control group of routinely clinically diagnosed ATTRwt patients.


Eligibility criteria: Inclusion Criteria:

* Men ≥65years or women ≥75years with unexplained AV-block with pacemaker indication, as decided per treating physician and presence of left ventricular hypertrophy ≥12mm.

Exclusion Criteria:

* Reversible causes for AV-block, som as AV-node disturbing medicament, ion-disturbances, hypothyroidism, hypoxia, ischemia, new heart surgery \<1month, endocarditis.

Primary outcomes:
measure: Diagnosis of ATTRwt in study cohort.
timeFrame: 3 years
Secondary outcomes:
measure: Characteristics of patients with ATTRwt
timeFrame: 3 years
measure: Clinical Stage of time of diagnosis in patients with ATTRwt
timeFrame: 3 years
measure: Number of heart-failure associated hospitalization among ATTRwt patients
timeFrame: 5 years
measure: All-cause mortality among ATTRwt patients.
timeFrame: 5 year
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Department of Cardiology, Aarhus University Hospital
Study officials:
affiliation: Department of Cardiology, Aarhus University Hospital
name: Steen Poulsen, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01773044: Pain on Injection of Propofol: a Comparison of Lidocaine and Alkalinized Lidocaine
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Pain on Injection of Propofol,Lidocaine, Alkalinized Lidocaine
Lead sponsor: Inonu University
Sponsor class: OTHER
First posted: 2013-01-23
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Aim: The aim of this study was to compare the efficacy of pretreatment 0.5 mg/kg lidocaine and 0.5 mg/kg alkalinized lidocaine for prevention of propofol induced pain.

Methods: In this double-blind, placebo controlled study, 300 adults patients ASA I or II, scheduled to undergo elective surgery, were randomly assigned into three groups of 100 each. Group L, recevied 0.05 mL/kg lidocaine (% 2 lidocaine 5 mL + 5 mL SF), Group A, 0.05 mL/kg lidocaine with bicarbonate ( % 2 lidocaine 5 mL + 1 mL %8,4 NaHCO3+ 4 mL SF) and control group received isotonic saline pretreatment in the dorsum of the hand, followed by propofol 30 sec later. A blinded researcher assessed the patient's pain level via a four-point scale.


Eligibility criteria: Inclusion Criteria:

* undergoing elective surgery

Exclusion Criteria:

* allergy to the study drug

Primary outcomes:
measure: Pain on injection of propofol
timeFrame: 5 th minutes after propofol injection
Secondary outcomes:
Other outcomes:
Locations:
city: Malatya
country: Turkey
facility: Inonu university medicine faculty
Study officials:
References:
citation: Borazan H, Erdem TB, Kececioglu M, Otelcioglu S. Prevention of pain on injection of propofol: a comparison of lidocaine with different doses of paracetamol. Eur J Anaesthesiol. 2010 Mar;27(3):253-7. doi: 10.1097/EJA.0b013e328330eca2.
Clinical trial NCT03547544: Rapid Urease Test for Diagnosis Helicobacter Pylori Infection
Official title: Effectiveness of Rapid Urease Test (Helicotec) for The Diagnosis of Helicobacter Pylori Infection in Dyspepsia Patients in Endoscopy Centre
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Helicobacter Pylori Infection
Keywords: helicobacter pylori
urease test
helicotec
Lead sponsor: Indonesia University
Sponsor class: OTHER
First posted: 2018-06-06
Enrollment: 97
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: General population: Jakarta citizen Targeted population: Patients of endoscopy centre Cipto Mangunkusumo Hospital Sample: Targeted population who undergo endoscopy examination and met the inclusion and exclusion criteria

Brief summary: Nowadays, the gold standard examinations for diagnosing H. pylori infection are histopathology and culture examination. However, those examinations take long preparation so they are not suitable to be applied in daily practice. In progress, another examination is being developed to detect urease enzyme from tissue biopsy. It is relatively faster in diagnosing H. Pylori infection. Some commercial urease tests which are available in Indonesia are Helicotec® and Pronto Dry®.

This study aims to determine the effectivity of Helicotec® in diagnosing H. pylori infection. It is expected to be scientific evidence that can be used as the basis daily routine of urease test in diagnosing H. Pylori infection.

Detailed description: This study is a diagnostic study. There will be 97 dyspepsia patients who met the inclusion and exclusion criteria. They will answer the questionnaire about personal data and examined physically. They will also undergo endoscopy, biopsy, and urease test using Helicotec®

Eligibility criteria: Inclusion Criteria:

* Adult (18-55 years old),
* Diagnosed with dyspepsia,
* Indicated for endoscopy,
* Agreed to participate in the study and signed the informed consent.

Exclusion Criteria:

* Pregnancy and breastfeeding woman,
* Patients with alarm symptom,
* History taking of antibiotics (amoxicillin, clarithromycin, levofloxacin), H2 receptor antagonist, proton pump inhibitor, misoprostol, sucralfat, bismuth, NSAIDs, steroid, rheumatoid drug within the last 2 weeks.

Primary outcomes:
measure: Effectivity of Helicotec
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Jakarta Pusat
country: Indonesia
facility: Cipto Mangunkusumo Hospital
state: DKI Jakarta
Study officials:
affiliation: Gastroenterology Division, Internal Medicine Department RSCM/UI
name: Ari F Syam, Dr, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00345644: Risedronate in Osteopenic Postmenopausal Women
Official title: A Non-invasive Evaluation of Bone Microarchitecture Modification in Osteopenic Postmenopausal Women by 3D Peripheral Quantitative Computed Tomography: A 24 Month, Monocenter Study Comparing Weekly Oral Risedronate 35 mg and Placebo
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Osteoporosis
Keywords: Postmenopausal
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
Collaborators: name: Procter and Gamble
First posted: 2006-06-28
Enrollment: 156
Sex: FEMALE
Minimum age (years): 55
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary objective of this study is to compare risedronate 35 mg and placebo with respect to the percent change at 12 months for distal radius trabecular bone volume (BV/TV) in osteopenic postmenopausal women, as measured by three-dimensional peripheral quantitative computed tomography (3D pQCT).

The secondary objectives are to compare the percent change from Screening/Baseline between the 2 treatment groups for the following measurements:

* Bone mineral density of the lumbar spine, femoral neck, femoral trochanter, and total proximal femur using a dual energy X-ray absorptiometry (DXA) scan at 12 and 24 months;
* 3D pQCT analysis of distal radius and distal tibia bone microarchitecture data at 6, 12, and 24 months; and
* Bone turnover markers (BTMs) of:

  * fasting serum carboxyterminal cross linking telopeptide of type 1 bone collagen (CTX 1);
  * serum aminoterminal propeptide of type 1 procollagen (PINP); and
  * urine N-telopeptide cross-links (NTX) at 3, 6, 12, and 24 months.


Eligibility criteria: Inclusion Criteria:

* Osteopenic, postmenopausal women, between 55 and 75 years of age with a body mass index (BMI) \< 30 kg/m²

Exclusion Criteria:

* Clinical or radiological evidence of osteoporosis
* Severe renal impairment
* Serum 5-hydroxy vitamin D level \< 15 ng/ml
* History of recent primary hyperparathyroidism or recent thyroid disorder
* History of any generalized bone disease
* Current use of glucocorticoids, estrogens, progestins, calcium supplements \> 1 g/day, vitamin D supplements \> 800 IU/day, parathyroid hormone (PTH), or any bisphosphonate for \> 1 month at any time within the past 6 months.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Primary outcomes:
measure: Efficacy data : 3-D-pQCT Data-Microarchitectural Parameters (Distal Radius BV/TV Measurements)
timeFrame: BV/TV percent change from Baseline at distal radius as measured in the non dominant wrist at Month 12
Secondary outcomes:
measure: Tolerance data :collection of AEs, with special interest for upper gastrointestinal (UGI) AEs and clinical fractures
timeFrame: at all visits
Other outcomes:
Locations:
city: Paris
country: France
facility: Sanofi-Aventis
Study officials:
affiliation: Sanofi
name: Marie SEBILLE, Dr
role: STUDY_DIRECTOR
References:
Clinical trial NCT01685944: Anti-Obesity Effect of Pediococcus Pentosaceus LP28
Official title: A Randomized, Double-blind, Placebo Controlled Study to Evaluate the Effect of Pediococcus Pentosaceus LP28 on Obesity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Lead sponsor: Hiroshima University
Sponsor class: OTHER
First posted: 2012-09-14
Enrollment: 62
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study is designed to evaluate efficacy of Pediococcus pentosaceus LP28 in reducing body fat and body weight in subjects with BMI 25-30 kg/m2.


Eligibility criteria: Inclusion Criteria:

* BMI 25-30 kg/m2

Exclusion Criteria:

* Taking medicines or functional food that may affect body weight or body fat
* Pregnant or nursing a child
* Participation in any clinical trial within 90 days of the commencement of the trial
* Renal or hepatic dysfunction
* Heart disease

Primary outcomes:
measure: Body fat
timeFrame: Every 4 weeks (Overall 12 weeks)
measure: BMI
timeFrame: Every day (Overall 14 weeks)
Secondary outcomes:
measure: Abdominal circumference
timeFrame: Every 4 weeks (Overall 12 weeks)
measure: Serum triglyceride
timeFrame: Every 4 weeks (Overall 12 weeks)
measure: Total cholesterol
timeFrame: Every 4 weeks (Overall 12 weeks)
measure: LDL cholesterol
timeFrame: Every 4 weeks (Overall 12 weeks)
measure: HDL cholesterol
timeFrame: Every 4 weeks (Overall 12 weeks)
measure: Fasting blood glucose
timeFrame: Every 4 weeks (Overall 12 weeks)
measure: Fasting insulin
timeFrame: Weeks 0 and 12
measure: HOMA-R
timeFrame: Weeks 0 and 12
measure: Adiponectin
timeFrame: Weeks 0 and 12
measure: Leptin
timeFrame: Weeks 0 and 12
measure: Resistin
timeFrame: Weeks 0 and 12
Other outcomes:
Locations:
city: Hiroshima
country: Japan
facility: Hiroshima University
Study officials:
affiliation: Hiroshima University
name: Fumiko Higashikawa, PhD
role: PRINCIPAL_INVESTIGATOR
References: