louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01515293: Single Incision Versus Conventional Laparoscopic Appendectomy
Official title: Prospective Randomised Study Comparing Single Incision Transumbilical Versus Conventional Laparoscopic Appendectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Appendicitis
Lead sponsor: Hospital Universitario Virgen de la Arrixaca
Sponsor class: OTHER
First posted: 2012-01-24
Enrollment: 184
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is to compare the short-term outcomes of single-incision and conventional laparoscopic appendectomy.

Detailed description: Appendicitis is the most common abdominal emergency. The treatment is surgical and single incision laparoscopic surgery (SILS) involves performing laparoscopic surgery through a single transumbilical point, in an attempt to improve the results of laparoscopic surgery.

Eligibility criteria: Inclusion Criteria:

* Patients with suspected acute appendicitis

Exclusion Criteria:

* Perforated appendicitis

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Frutos MD, Abrisqueta J, Lujan J, Abellan I, Parrilla P. Randomized prospective study to compare laparoscopic appendectomy versus umbilical single-incision appendectomy. Ann Surg. 2013 Mar;257(3):413-8. doi: 10.1097/SLA.0b013e318278d225.
Clinical trial NCT04373993: Prehospital Minutes Count During a Stroke.
Official title: Prehospital Minutes Count During a Stroke. Factors Associated With Prehospital Delays With Data From Various Regions in Norway and One Region in Switzerland
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Stroke, Acute
Lead sponsor: Nordlandssykehuset HF
Sponsor class: OTHER
Collaborators: name: University Hospital, Akershus
First posted: 2020-05-05
Enrollment: 1100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All patients discharged from the respective hospitals with a diagnosis of stroke during the period of inclusion.

Brief summary: The ultimate objective is to improve the efficacy of prehospital procedures for patients suffering an acute stroke. Increased precision in prehospital selection and a more efficient transport chain will lead to an even more rapid start of treatment and thus benefit patients. The research project has two parts: one part collecting data from medical reports and one study with qualitative in-depth interviews. The project will gather data from various parts of Norway and from a University hospital in Switzerland for comparison between regions and countries. Data will be retrieved through intrahospital and prehospital medical records from various parts of Norway (Nordland Hospital, Akershus University Hospital and Helgeland Hospital) and from Basel University hospital in Switzerland. Knowledge of factors associated with delays will be compared for regions in the north and south of Norway, as well as abroad. The information obtained will be analysed to identify components in the chain that may be improved as concerns time saving.


Eligibility criteria: Inclusion Criteria:

• Final diagnosis of stroke at discharge from hospital

Exclusion Criteria:

• Hospital admission later than one week from stroke onset

Primary outcomes:
measure: Time delay from ictus to hospital arrival
timeFrame: Within 4 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Bodø
country: Norway
facility: Maria Carlsson
Study officials:
References:
Clinical trial NCT03085693: Impact of Left Atrial Appendage Closure on Physical Capacity.
Official title: Impact of Left Atrial Appendage Closure With a Closure Device on Quality of Life, Physical Capacity and Expression of Atrial Natriuretic Peptide and Brain Natriuretic
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Atrial Fibrillation
Lead sponsor: University of Leipzig
Sponsor class: OTHER
Collaborators: name: University of Jena
First posted: 2017-03-21
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients before and after closure of the left atrial appendage

Brief summary: Closure of the left atrial appendage in patients with atrial fibrillation and risk for stroke is a increasing technology leading to exclusion of the left atrial appendage volume from the blood circulation and therefore protects from cardioembolic strokes- It is unclear if the volume reduction of the left atrium leads to a change in exercise capacity or Quality of life.

Detailed description: The monocentric trial deals with the endocrinological changes as a result of closure of the left atrial appendage with a internal closure device. Specially, the changes in atrial natriuretic peptide, brain natriuretic peptide and their impact on exercise capacity is on focus of the trial. The trial is planned as a all comers trial.

Eligibility criteria: Inclusion Criteria:

* Patient with a indication for LAA closure device Implantation

Exclusion Criteria:

* Inability to perform exercise testing

Primary outcomes:
measure: exercise capacity measured by maximal oxygen consumption
timeFrame: Baselina, 45 days, 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Jena
country: Germany
facility: University of Jena
Study officials:
affiliation: University of Jena
name: Sven Möbius-Winkler, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02904993: Study Comparing Regional Anesthetic Blocks and Periarticular Infiltration for the Management of Post-operative Pain After Direct Anterior Total Hip Arthroplasty
Official title: Prospective Randomized Study Comparing Regional Anesthetic Blocks and Periarticular Infiltration for the Management of Post-operative Pain After Direct Anterior Total Hip Replacement
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Degenerative Joint Disease
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2016-09-19
Enrollment: 9
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: To compare two methods of post-operative pain management in patients undergoing total hip arthroplasty. There is a perception that the periarticular injections may not be as effective in controlling post-operative pain.

Both methods are current standard of care. The investigators want to compare the outcomes of each when patients are randomized to one of the methods compared to the other method of post-operative pain control.


Eligibility criteria: Inclusion Criteria:

* Subject scheduled for Direct Anterior unilateral total hip replacement
* Weight ≥ 50 and ≤125 kg
* Intact neurological exam
* Cognitively intact with ability to sign consent

Exclusion Criteria:

* Renal insufficiency with creatinine \> 1.5 mg/dl
* Allergic to any of the following : Ropivacaine, Epinephrine, Ketorolac, Morphine sulfate, NSAIDs, Tylenol, Neurontin, Morphine, Oxycodone or Dilaudid.
* Subject taking regular narcotic medications prior to surgery (20mg/day Morphine equivalents for \>7days)
* Subject with prior open hip surgery who received regional anesthesia or periarticular injection for post op pain management.
* Subject with contraindication for spinal anesthesia

Primary outcomes:
measure: Changes in pain score
timeFrame: post-operative to 7 days
Secondary outcomes:
Other outcomes:
Locations:
city: Jacksonville
country: United States
facility: Mayo Clinic in Florida
state: Florida
Study officials:
affiliation: Mayo Clinic
name: John M Redmond
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05014893: Neural Mechanisms of Cognitive Assessment and Rehabilitation for Cognitive Decline
Official title: Neural Mechanisms of Cognitive Assessment and Rehabilitation for Cognitive Decline
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Mild Cognitive Impairment (MCI)
Subjective Cognitive Decline (SCD)
Aging
Healthy
Lead sponsor: National Research Center for Rehabilitation Technical Aids
Sponsor class: OTHER
Collaborators: name: Nanjing Brain Hospital
name: The Third People's Hospital of Yunnan Province
name: Central South University
name: Beijing academy of science and technology
name: Beijing University of Chinese Medicine
First posted: 2021-08-20
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief summary: This study investigates the neural mechanisms of cognitive function decline, cognitive assessment methods for subjects with mild cognitive dysfunction (Mild cognitive impairment, MCI, or cognitive decline milder than MCI), and the approaches used to improve and restore cognitive function.

Detailed description: Cognitive assessment tools are used to assess cognitive function of subjects in different cities. Functional and structural MRI and EEG are applied to investigate the neural mechanisms of cognitive function decline and effects of methods to improve and restore cognitive function.

Eligibility criteria: Inclusion Criteria:

* Adults being able to walk at least a block, and
* Adults with subjective cognitive decline (SCD), or
* Adults with mild cognitive impairment (MCI), or
* Adults with normal cognitive function

Exclusion Criteria:

* Clinical diagnosis of dementia
* Adults who cannot follow the protocal

Primary outcomes:
measure: Change in Cognitive function (SCD-9)
timeFrame: Change from Baseline Cognitive test results at 3 months.
measure: Change in Cognitive function (MoCA)
timeFrame: Change from Baseline Cognitive test results at 3 months.
measure: Change in Cognitive function (AD8)
timeFrame: Change from Baseline Cognitive test results at 3 months.
measure: Change in Cognitive function (CDR)
timeFrame: Change from Baseline Cognitive test results at 3 months.
Secondary outcomes:
measure: Change in Physical capacity (TUG)
timeFrame: Change from Baseline physical capacity test results at 3 months.
measure: Change in Physical capacity (chair standing)
timeFrame: Change from Baseline physical capacity test results at 3 months.
Other outcomes:
measure: Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
timeFrame: Up to 24 months.
Locations:
city: Beijing
country: China
facility: National Research Center for Rehabilitation Technical Aids
state: Beijing
Study officials:
affiliation: National Research Center for Rehabilitation Technical Aids
name: Pengxu Wei
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01825993: RANDOMISED STUDY OF EPIDURAL VS MPCA MORPHINE VS TAPP IN LAPAROSCOPIC SIGMOIDECTOMY
Official title: RANDOMISED STUDY ABOUT POTSOTERATORY PAIN CONTROL IN LAPAROSCOPIC SIGMOIDECTOMY
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Sigmoidal Tumour
Keywords: Peridural catheter
Morphine PCA
Transabdominal Block
laparoscopic sigmoidectomy
Lead sponsor: Corporacion Parc Tauli
Sponsor class: OTHER
First posted: 2013-04-08
Enrollment: 225
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The investigators would study the control of postoperative pain with peridural catheter, morphine PCA ev or Transabdominal block.


Eligibility criteria: Inclusion Criteria:

* Age more than 18
* Laparoscopic sigmoidectomy
* Informed consent firmed

Exclusion Criteria:

* ASA IV
* Urgent surgery
* Sigmoid tumour stage IV
* Cronic pain treatment
* No informed consent firmed
* Paliative surgery

Primary outcomes:
measure: EVA (POSTOPERATIVE PAIN)
timeFrame: 72 H POSTOPERATIVE
Secondary outcomes:
measure: ADVERSE EFFECTS
timeFrame: five days
Other outcomes:
Locations:
city: Sabadell
country: Spain
facility: Corporacion Parc Tauli
state: Sabadell-Barcelona
city: Sabadell
country: Spain
facility: Corporacion Parc Tauli
state: Sabadell-barcelona
Study officials:
affiliation: Corporacion Parc Tauli
name: PUJOL GEMMA, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04236193: Ultrasound and Immunological Findings in Patients With Shoulder Injury Related to Vaccine Administration (SIRVA)
Official title: Ultrasound and Immunological Findings in Patients With Shoulder Injury Related to Vaccine Administration (SIRVA)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Shoulder Injury Related to Vaccine Administration
Erosion, Localized
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
First posted: 2020-01-22
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects receiving the Influenza vaccine at a local vaccination campaign in Basel, Switzerland

Brief summary: Accidental vaccine injection into adjunct shoulder structures can cause tissue damage, termed Shoulder injury related to vaccine administration (SIRVA). The immunopathological mechanisms and consequences of SIRVA are unknown.

The study assesses the clinical and immunological consequences of an influenza vaccine if accidentally administered in periarticular space.


Eligibility criteria: Inclusion Criteria:

* participation at a local vaccination campaign
* Shoulder pain \>3 days after vaccination

Exclusion Criteria:

* no vaccine received
* preexisting shoulder pathology

Primary outcomes:
measure: Pathological Findings in Ultrasound
timeFrame: Ultrasound of the shoulder is performed at Baseline/Inclusion
Secondary outcomes:
measure: Increased Vaccine response
timeFrame: Baseline and 12 months
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: University Hospital Basel
Study officials:
affiliation: University Hospital, Basel, Switzerland
name: Christoph Berger, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04830293: Effect of Head Position During Thyroidectomy on Postoperative Cognitive Functions
Official title: The Effect of Head Position During Thyroidectomy on Cerebral Oxygenation and Postoperative Cognitive Functions
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Thyroid
Carotid Doppler
Cerebral Perfusion
Keywords: Head position
Cerebral Oxygenation
Postoperative Cognitive Dysfunction
Lead sponsor: Zonguldak Bulent Ecevit University
Sponsor class: OTHER
First posted: 2021-04-05
Enrollment: 1
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients between the ages of 18-50 who will undergo total thyroidectomy under general anesthesia due to elective thyroid cancer, Hashimoto's thyroiditis or thyrotoxicosis, in the American Society of Anesthesiologists (ASA) I-II risk group, who are euthyroid in the preoperative period

Brief summary: The aim of our study is to observe the effect of head-neck position of patients scheduled for thyroidectomy, on carotid artery blood flow, regional cerebral oxygen saturation measured using near-infrared spectroscopy technology, and postoperative cognitive dysfunction.


Eligibility criteria: Inclusion Criteria:

* undergo a total thyroidectomy operation
* ASA I-II
* euthyroid patients in the preoperative period

Exclusion Criteria:

* Hemoglobin\< 8 g / dl
* Hypertension
* Hyperlipidemia
* Pregnancy
* Patients diagnosed with diabetes mellitus
* Cerebrovascular insufficiency
* Known carotid artery lesion
* Metabolic diseases
* Any intracranial pathology present
* Surgeries exceeding 180 minutes

Primary outcomes:
measure: Changes in cognitive functions
timeFrame: 3 months after surgery
Secondary outcomes:
measure: Changes in Cerebral Perfusion
timeFrame: during surgery
Other outcomes:
Locations:
city: Zonguldak
country: Turkey
facility: Zonguldak Bülent Ecevit University Medicine Faculty
state: Kozlu
Study officials:
References:
Clinical trial NCT05394493: An Observational Chart Review Study To Describe The Real-World Outcomes And Use Of Avelumab In Combination With Axitinib For Treatment Of Patients With aRCC In The UK
Official title: An Observational Chart Review Study to Describe the Real-world Outcomes and Use of Avelumab in Combination With Axitinib for Treatment of Patients With Advanced Renal Cell Carcinoma in the United Kingdom.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Advanced Renal Cell Carcinoma
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2022-05-27
Enrollment: 130
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study will be conducted in between 10 and 15 National Health Service (NHS) hospital trusts and Health Boards

Brief summary: An observational chart review study to describe the real-world outcomes and use of avelumab in combination with axitinib for treatment of patients with advanced renal cell carcinoma in the United Kingdom.


Eligibility criteria: Inclusion criteria

* Patients must meet all of the following inclusion criteria to be eligible for inclusion in the study:
* Patients with a documented diagnosis of aRCC.
* Patients aged ≥18 years old at the index event date.
* Patient initiated on treatment with avelumab in combination with axitinib ( ≥1 dose) on or after 1st August 2019.

Exclusion criteria

* Patients meeting any of the following criteria will not be included in the study:
* Patients who received avelumab in combination with axitinib as part of a clinical trial
* Patients initiated on avelumab in combination with axitinib less than 12 months from the end of data collection.
* Patients who are known to have opted out of participation in any research

Primary outcomes:
measure: Objective response (OR)
timeFrame: August 2019 through July 2023
measure: Overall Survival (OS)
timeFrame: August 2019 through July 2023
measure: Progression Free Survival (PFS)
timeFrame: August 2019 through July 2023
measure: Duration of Response (DoR)
timeFrame: August 2019 through July 2023
measure: Duration of Treatment (DoT)
timeFrame: August 2019 through July 2023
Secondary outcomes:
Other outcomes:
Locations:
city: Sandwich
country: United Kingdom
facility: Pfizer Ltd
state: Kent
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT06443593: Effect of Micronutrient Supplementation on Nerve Conduction Velocity in T1D- RCT
Official title: Vitamin B12, Vitamin D and Iron Supplementation for Improvement of Nerve Conduction Velocities in Children and Youth With Type 1 Diabetes
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Type 1 Diabetes
Keywords: Diabetic neuropathy
children and youth with type 1 diabetes
vitamin B12
vitamin D
oral iron
Nerve conduction velocity
Lead sponsor: Hirabai Cowasji Jehangir Medical Research Institute
Sponsor class: OTHER
First posted: 2024-06-05
Enrollment: 120
Sex: ALL
Minimum age (years): 10
Maximum age (years): 22
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Type 1 diabetes can complicate to peripheral neuropathy due to preferential involvement of small unmyelinated nerve fibers (pain and temperature sensation) followed by myelinated nerve fibers (vibration and proprioception). The SEARCH for diabetes in youth study found diabetic neuropathy in 7% of T1D youth. The clinical form of peripheral neuropathy is rare in childhood and pathophysiological changes begin during childhood and accelerate in puberty. Adolescents with these changes can be picked up more reliably by electrophysiological studies than by clinical examination. Nerve conduction studies are the gold standard diagnostic tests for detection of peripheral neuropathy. Role of vitamin B12 in nerve regeneration is well known while causal association of vitamin D deficiency in type 1 diabetes and its role in axonal degeneration is also reported. The previous ongoing studies from authors' group have shown relationship between poor oral iron intake and subclinical neuropathy in children with type 1 diabetes (manuscript in submission). The present randomised clinical trial is aimed at assessing vitamin B12, vitamin D and iron supplementation for improvement of nerve conduction velocities in children and youth with type 1 diabetes.


Eligibility criteria: Inclusion Criteria:

1. Children/ parents/ youth willing to participate in the study with an informed consent/ assent.
2. Children/ youth Age \> 10 years
3. Diabetes duration \> 2 years
4. Diagnosed with type 1 diabetes

Exclusion Criteria:

1. Age \< 10 years
2. Diabetes duration \< 2 years
3. Children/ youth receiving vitamin B12, vitamin D and/or oral iron supplements
4. Children/ youth with any other disease condition involving nerve or muscle function
5. Children/ parents/ youth not willing to consent to participate in the study.

Primary outcomes:
measure: Nerve conduction velocity
timeFrame: 6 months
measure: Serum vitamin B12, serum ferritin, serum vitamin D3
timeFrame: 6 months
Secondary outcomes:
measure: Dynamic muscle function
timeFrame: 6 months
measure: Dynamic muscle function
timeFrame: 6 months
measure: Glycemic control (HbA1c)
timeFrame: 6 months
Other outcomes:
Locations:
city: Pune
country: India
facility: Hirabai Cowasji Jehangir Medical Research Institute
state: Maharashtra
Study officials:
References: