louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06808594: The Use of Adaptive Proximal Scaphoid Implant (APSI): Long Term Follow-up
Official title: The Use of APSI: Long Term Follow-up
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Scaphoid Non-union Advanced Collapse (SNAC Wrist)
Keywords: osteoarthritis
arthroplasty
Scaphoid fracture
Pyrocarbon
Bone implant
Lead sponsor: Azienda Ospedaliera Universitaria Integrata Verona
Sponsor class: OTHER
First posted: 2025-02-05
Enrollment: 36
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Retrospective study
Primary purpose: TREATMENT

Brief summary: Scaphoid proximal pole fracture with avascular necrosis is a complex surgical problem. In some cases, it's possible to perform a scaphoid hemiarthroplasty with an adaptative proximal scaphoid implant (APSI), made of pyrocarbon, replacing the necrotic proximal pole. APSI allows an early mobilization of the wrist, an optimal recovery of strength and a rapid return to normal daily and work activities without limitations. This implant delays palliative and more invasive surgical treatments in patients that are generally young with high functional demands. The investigators have performed a long-term follow up (with a mean follow-up of 17 years) of the early cases of APSI implant performed, starting from 1999. Radiographic and clinical strength recovery, along with subjective outcomes, have been shown to be good, with a rapid return to daily and work activities, indicating that APSI implants are a good alternative to traditional and invasive techniques.


Eligibility criteria: Inclusion Criteria:

* patients who underwent APSI implant surgery in the period from December 1999 to December 2016, with surgery performed via dorsal or volar approach in the case of previous surgical access;
* collection of informed consent to the processing of personal data by the Patients contacted in order to be included in the study.

Exclusion Criteria:

* patients for whom it was not possible to obtain informed consent to the processing of personal data.

Primary outcomes:
measure: Radiographic outcome
timeFrame: Through study completion, an average of 17 year
Secondary outcomes:
measure: DASH (Disabilities of the Arm, Shoulder, and Hand)
timeFrame: Through study completion, an average of 17 year
measure: PRWE (Patient Rated Wrist Evaluation)
timeFrame: Through study completion, an average of 17 year
measure: VAS (Visual Analogue Scale)
timeFrame: Through study completion, an average of 17 year
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04801394: Retrospective Analysis on Large Incisional Hernia in High Risk Patients
Official title: Retrospective Analysis on Large Incisional Hernia in High Risk Patients: the Innovative "Neo-peritoneum" Approach With a Composite Mesh
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Incisional Hernia
Large Incisional Hernia
Lead sponsor: University of Campania Luigi Vanvitelli
Sponsor class: OTHER
First posted: 2021-03-17
Enrollment: 43
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Large incisional hernia (LIH) is a challenging condition where the abdominal wall is hopelessly compromised. Nowadays the best treatment option in this particularly frail subset of patients is a major issue. The Auhtors proposed the clinical experience with an innovative approach with the composite Free Lateral Polypropylene prosthesis (FLaPp®) mesh fashioned as "neoperitoneum" analyzing its feasibility and short/medium term results.


Eligibility criteria: Inclusion Criteria:

* symptomatic patients with midline Large incisional hernia

Exclusion Criteria:

* lateral incisional hernias
* collagen diseases
* patients who recently have undergone chemotherapy and/or radiation therapy
* patients with acquired immunodeficiency

Primary outcomes:
measure: Early surgical outcome of FLaPp® prosthesis classified according to Clavien Dindo Classification
timeFrame: one month
measure: Evaluation of pain after FLaPp® prosthesis
timeFrame: one month
measure: Mortality after FLaPp® prosthesis
timeFrame: One month
Secondary outcomes:
measure: incisional hernia recurrence at medium term
timeFrame: 36 months
measure: Patients' satisfatcion after FLaPp® prosthesis
timeFrame: 36 months
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00867594: Effectiveness of Oral Insulin in Unstable Type 1 Diabetes Patients
Official title: A Single Blind, Open-Label Study to Assess the Safety, Pharmacokinetics and Pharmacodynamics of Oral Insulin Formulation in Type 1 Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Brittle Type I Diabetes Mellitus
Lead sponsor: Hadassah Medical Organization
Sponsor class: OTHER
Collaborators: name: Oramed Pharmaceutical Inc.
First posted: 2009-03-24
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The intent of the proposed study is to assess the potential of oral insulin to mitigate diabetic instability and reduce the frequency and severity of hypoglycemic episodes in patients with type 1 diabetes. Restoring hepatic glycogen stores is critical for the normalization of counter-regulation to hypoglycemia in these patients. Oral insulin can provide a means to increase portal insulin levels, shift the ratio of insulin/glucagon in favor of glycogenesis while sparing the patient the risk of hypoglycemia due to peripheral hyperinsulinemia


Eligibility criteria: Inclusion Criteria:

* Type 1 diabetes mellitus
* Male or female aged 18-50 years inclusive
* Body weight between 50-100kg and BMI between 18 and 30 kg/m2
* Diagnosed 6 or more months ago, unstable diabetes with frequent episodes of hypoglycemia
* No other medical problems

Exclusion Criteria:

* History or presence of clinical significant gastrointestinal pathology or symptoms, liver or kidney disease or any condition that might interfere with the absorption, distribution, metabolism or excretion of the drug
* Positive pregnancy test or lactation
* Lack of family support
* Unwilling or unable to follow the study protocol
* Concurrent medical problems

Primary outcomes:
measure: To determine the safety and tolerability of multi-doses of Oramed oral insulin in people with type 1 diabetes
timeFrame: 15 days
Secondary outcomes:
measure: To determine if oral insulin is likely to improve glycemic stability assessed by the reduction of the frequency and severity of hypoglycemic episodes in people with unstable type 1 diabetes
timeFrame: 15 days
Other outcomes:
Locations:
city: Jerusalem
country: Israel
facility: Hadassah University Hospital
Study officials:
affiliation: Hadassah
name: Roy Eldor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Eldor R, Arbit E, Corcos A, Kidron M. Glucose-reducing effect of the ORMD-0801 oral insulin preparation in patients with uncontrolled type 1 diabetes: a pilot study. PLoS One. 2013 Apr 9;8(4):e59524. doi: 10.1371/journal.pone.0059524. Print 2013.
Clinical trial NCT01238094: Trial of XELIRI/FOLFIRI + Simvastatin Followed by Simvastatin Maintenance in Metastatic Colorectal Cancer
Official title: Placebo-controlled, Double-blinded Phase III Trial of XELIRI/FOLFIRI + Simvastatin Followed by Simvastatin Maintenance in Metastatic Colorectal Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Colorectal Cancer
Keywords: colorectal cancer
simvastatin
second-line chemotherapy
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
First posted: 2010-11-10
Enrollment: 258
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare 2nd line XELIRI/FOLFIRI + simvastatin vs XELIRI/FOLFIRI + placebo.

Detailed description: To compare progression free survival of the standard second line chemotherapy (FOLFIRI, XELIRI) plus simvastatin in metastatic colorectal cancer patients. This trial is a placebo-controlled study.

Eligibility criteria: Inclusion Criteria:

1. Histologically documented colorectal adenocarcinoma (previously failed to oxaliplatin)
2. Age over 19 years old
3. Performance status (ECOG scale): 0-2
4. Measurable or evaluable disease
5. Adequate organ functions
6. Life expectancy ≥ 3 months
7. No history of statin treatment within the last 12 months
8. Patients should sign a written informed consent before study entry.

Exclusion Criteria:

1. Tumor type other than adenocarcinoma
2. Second primary malignancy (except in situ carcinoma of the cervix or adequately treated basal cell carcinoma of the skin, papillary thyroid carcinoma or prior malignancy treated more than 5 years ago without recurrence)
3. Adjuvant or neo-adjuvant treatment for non-metastatic (M0) disease is allowed if completed at least 6 months prior to initiation of study treatment.
4. Prior radiotherapy is permitted if it was not administered to target lesions selected for this study, unless progression of the selected target lesions within the radiation portal is documented, and provided it has been completed at least 4 weeks before randomization.

Primary outcomes:
measure: Progression free survival
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
Study officials:
affiliation: Samsung Medical Center
name: Won Ki Kang, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03860194: Effects of Dietary Supplements on Sarcopenic Elders
Official title: Effects of Adequate Dietary Protein With Whey Protein, Leucine, and Vitamin D Supplementation on Sarcopenia in Elderly Subjects：An Open-label, Parallel-group Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sarcopenia
Lead sponsor: Far Eastern Memorial Hospital
Sponsor class: OTHER
First posted: 2019-03-01
Enrollment: 85
Sex: ALL
Minimum age (years): 65
Maximum age (years): 95
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Sarcopenia is defined as a syndrome characterized by decline of skeletal muscle mass and strength or an alteration in physical function. Although some studies showed nutritional supplementation alone might have health benefits for older sarcopenic patients, the results were inconsistent and remain controversial. The objective of this study was to evaluate if a sufficient protein diet including supplements with leucine-enriched whey protein and vitamin D can lead to better improvement than sufficient dietary protein alone in maintaining muscle mass and strength among sarcopenic elders.


Eligibility criteria: Inclusion Criteria:

* Older adults (≥ 65 years)
* Subject has lower appendicular muscle mass index (AMMI) (\<7 kg/m\^2 in men; \<5.7 kg/m\^2 in women) using Bioelectrical impedance analysis (BIA, TANITA BC-418®, Tokyo, Japan)
* Subject has lower handgrip strength (\<26 kg in men; \<18 kg in women) using dynamometer (CAMRY®, Zhongshan, Guangdong) or slowly gait speed (\<1 m/s)

Exclusion Criteria:

* Subject's life expectancy was shorter than 6 months
* Nursing home resident
* Subject has the history of kidney failure
* Subject has the history of liver failure
* Subject has the history of diabetes mellitus
* Subject has resistance exercise habit.

Primary outcomes:
measure: AMMI(appendicular muscle mass index)
timeFrame: Change measures (baseline and 4 weeks, baseline and 12 weeks)
measure: Handgrip strength
timeFrame: Change measures (baseline and 4 weeks, baseline and 12 weeks)
measure: Gait speed
timeFrame: Change measures (baseline and 4 weeks, baseline and 12 weeks)
Secondary outcomes:
Other outcomes:
Locations:
city: New Taipei City
country: Taiwan
facility: Far Eastern Memorial Hospital
state: Banciao Dist
Study officials:
affiliation: Family Medicine department
name: Chih-Chien Lin
role: STUDY_CHAIR
References:
citation: Lin CC, Yeh SL. Reply to the letter to the editor: Effects of adequate dietary protein with whey protein, leucine, and vitamin D supplementation on sarcopenia in older adults: An open-label, parallel-group study. Clin Nutr. 2022 Mar;41(3):792-793. doi: 10.1016/j.clnu.2022.01.030. Epub 2022 Feb 5.
citation: Lin CC, Shih MH, Chen CD, Yeh SL. Effects of adequate dietary protein with whey protein, leucine, and vitamin D supplementation on sarcopenia in older adults: An open-label, parallel-group study. Clin Nutr. 2021 Mar;40(3):1323-1329. doi: 10.1016/j.clnu.2020.08.017. Epub 2020 Aug 27.
Clinical trial NCT06165094: Effect of Cervical Paraesophageal Lymph Node Metastasis Versus Supraclavicular Lymph Node Metastasis on the Overall Survival of Patients With Thoracic Esophageal Squamous Cell Carcinoma: An Observational Study
Official title: Effect of Cervical Paraesophageal Lymph Node Metastasis Versus Supraclavicular Lymph Node Metastasis on the Overall Survival of Patients With Thoracic Esophageal Squamous Cell Carcinoma: An Observational Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Esophageal Cancer
Keywords: oesophageal squamous cell carcinoma; cervical paraesophageal lymph node metastasis; supraclavicular lymph node metastasis; lymphadenectomy; esophagectomy
Lead sponsor: Sichuan Cancer Hospital and Research Institute
Sponsor class: OTHER
First posted: 2023-12-11
Enrollment: 122
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Demographic and pathologic data, including gender, age, pathological T stage, pathological N stage, 8th tumor-node-metastasis (TNM) stage, tumor location, tumor grade, lymphovascular invasion, perineural invasion, LNM, cervical paraesophageal LNM, supraclavicular LNM, and radical resection, were collected from the Sichuan Cancer Hospital and Institute Esophageal Cancer Case Management (SCH-ECCM) database.

Brief summary: The goal of this observational study is to learn about in health conditions of ESCC. The main question\[s\] it aims to answer are:

•Lymph node metastasis(LNM) in cervical paraesophageal or supraclavicular which influence OS more.

Participants will describe the main status quo after surgery

Researchers will compare Lymph node metastasis(LNM) in cervical paraesophageal and supraclavicular to see if dead.

Detailed description: Demographic and pathologic data, including gender, age, pathological T stage, pathological N stage, 8th tumor-node-metastasis (TNM) stage, tumor location, tumor grade, lymphovascular invasion, perineural invasion, LNM, cervical paraesophageal LNM, supraclavicular LNM, and radical resection, were collected from the Sichuan Cancer Hospital and Institute Esophageal Cancer Case Management (SCH-ECCM) database.

Eligibility criteria: The inclusion criteria were as follows:

* patients who had undergone esophagectomy and
* patients who exhibited LNM in the supraclavicular region.

The exclusion criteria:

* tumor location outside the thoracic region,
* pathological examination results confirming the presence of non-squamous cell carcinoma, - patients with both cervical paraesophageal LNM and supraclavicular LNM, or
* those with missing required data

Primary outcomes:
measure: Overall survival
timeFrame: 2009.01.01-2017.12.30
Secondary outcomes:
Other outcomes:
Locations:
city: Chengdu
country: China
facility: Sichaun cancer hospital
state: Sichuan
Study officials:
References:
Clinical trial NCT04683094: Comparative Study for the Validity of Various Severity Scoring System
Official title: Comparative Study for the Validity of Various Severity Scoring System in the Surgical Intensive Care Unit at Aswan University Hospital
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Head Trauma
Polytrauma
Pre-Eclampsia
Sepsis
Septic Shock
Keywords: APACH IV; SAPS III , SOFA score
Lead sponsor: Aswan University Hospital
Sponsor class: OTHER
First posted: 2020-12-24
Enrollment: 200
Sex: ALL
Minimum age (years): 16
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: newly admitted patients to the Surgical Intensive Care Unit at Aswan University Hospital

Brief summary: Scoring systems for use in intensive care unit (ICU) patients have been introduced and developed over the last 30 years. They allow an assessment of the severity of disease and provide an estimate of in-hospital mortality

Detailed description: Severity scoring systems that are commonly used in critical care settings include Acute Physiology and Chronic Health Evaluation (APACHE), which was developed in the 1980s for predicting mortality, Simplified Acute Physiology Score (SAPS), and Mortality Probability Model (MPM). Although these scoring systems use different variables and weights for the classification of disease severity, they commonly monitor parameters such as heart rate, blood pressure, neurological state, and clinical data as these factors significantly deviate from physiological normality in the progression of critical disease. Old age and chronic disease are also captured by the scoring systems. Sequential Organ Failure Assessment (SOFA) score, which is based on organ failure over time to evaluate morbidity and multiple organ dysfunction is also used.

Eligibility criteria: Inclusion Criteria:

* newly admitted patients to the Surgical Intensive Care Unit with head trauma multiple trauma craniotomy sepsis preeclampsia - eclampsia postop. for vascular surgery

Exclusion Criteria:

less than 16 years old, readmitted to the ICU during the study period as only the first admission will be considered, ICU length of stay (LOS) less than 24 h

Primary outcomes:
measure: Acute Physiology and Chronic Health Evaluation (APACHE) IV
timeFrame: the first 24 hours after ICU admission
measure: Simplified Acute Physiology Score (SAPS III)
timeFrame: the first 24 hours after ICU admission
measure: Sequential Organ Failure Assessment (SOFA) score
timeFrame: the first 24 hours after ICU admission
Secondary outcomes:
Other outcomes:
Locations:
city: Aswan
country: Egypt
facility: Huda Fahmy
Study officials:
affiliation: Aswan University
name: huda fahmy
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03890094: Safety and Efficacy of Sufentanil Combined With Midazolam in Bronchoscopy Under Conscious Sedation: Retrospective Study
Official title: Safety and Efficacy of Sufentanil Combined With Midazolam in Bronchoscopy Under Conscious Sedation: Retrospective Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bronchoscopy
Sedation
Keywords: Sufentanil
Bronchoscopy
Conscious sedation
midazolam
Lead sponsor: Guangzhou Institute of Respiratory Disease
Sponsor class: OTHER
First posted: 2019-03-26
Enrollment: 11158
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: According to guidelines of bronchoscopy, patients had no food by mouth for 4h and to allow clear fluids by mouth up to 2 h before bronchoscopy. Oxygen supplementation was given to the patients through the nasal cannula (2-5L/min, adjusted as needed). 2% lidocaine was applied for topical anesthesia. Sufentanil and midazolam were applied intravenously.

Brief summary: The aim of this study was to determine the safety and efficacy of sufentanil combined with midazolam in bronchoscopy under conscious sedation. A retrospective analysis was conducted on all patients undergoing bronchoscopy applying sufentanil and midazolam under conscious sedation in the First Affiliated Hospital of Guangzhou Medical University from September 2013 to July 2017.


Eligibility criteria: Inclusion Criteria:

Patients who had undergone bronchoscopy applying topical lidocaine, sufentanil and midazolam under conscious sedation in the First Affiliated Hospital of Guangzhou Medical University from September 2013 to July 2017

Exclusion Criteria:

Patients who had undergone bronchoscopy not applying topical lidocaine, sufentanil and midazolam under conscious sedation

Primary outcomes:
measure: Oxygen desaturation
timeFrame: during the procedure
Secondary outcomes:
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: The Affiliated Hospital of Guangzhou Medical University
state: Guangdong
Study officials:
affiliation: The First Affiliated Hospital of Guangzhou Medical University
name: Shiyue Li, Professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05212194: The Relationship Between Post Dural Puncture Headache and Joint Laxity
Official title: The Relationship Between Post Dural Puncture Headache and Joint Laxity
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Postdural Puncture Headache
Lead sponsor: Adiyaman University Research Hospital
Sponsor class: OTHER
First posted: 2022-01-27
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Post-spinal headache is divided into 3 according to the severity scale. It is divided into 3 groups as mild, moderate and severe according to the presence of symptoms such as nausea, vomiting, and dizziness that prevent daily activity.

It has been reported that CSF leakage may be higher due to the weakness of the regional dural sac in primary connective tissue diseases with joint laxity and isolated joint hypermobility. Joint laxity is scored according to the level of motion in 5 different joints and a maximum of 9 points is obtained.

In this study, it was aimed to investigate whether joint laxity contributes to the development of post-spinal headache by questioning the correlation between joint laxity examination score and postspinal headache in patients with post-spinal headache.

Detailed description: Post dural puncture headache (PDPH), also known as post lumbar puncture (LP) headache, is a common complication of diagnostic LP. It also can occur following spinal anesthesia or, more commonly, inadvertent dural puncture during attempted epidural catheter placement. The headache is usually positional (worse when upright, better when lying flat) and is often accompanied by neck stiffness, photophobia, nausea, or subjective hearing symptoms.

In various studies, common patient risk factors for PDPH have included female gender, pregnancy, age 18 to 50 years compared with older or younger ages, and a prior history of headache

Additionally it has been thought that joint laxity contributes to the development of post dural puncture headache. However, no study has been found in the literature examining this relationship between them. In thıs study it was aimed to investigate the relationship between joint laxity and post dural puncture headache.

Eligibility criteria: Inclusion Criteria:

* 18-65 age
* the patients who develop PDPH

Exclusion Criteria:

* \<18 and \>65 age
* the patients refused to participate in the study

Primary outcomes:
measure: Post dural puncture headache (PDPH) severity
timeFrame: 24 hours after spinal anesthesia
measure: joint laxity score
timeFrame: 24 hours after spinal anesthesia
Secondary outcomes:
Other outcomes:
Locations:
city: Adıyaman
country: Turkey
facility: Adıyaman Training and Research Hospital
Study officials:
affiliation: Adiyaman Training and Research Hospital
name: Nezir yılmaz, Dr
role: PRINCIPAL_INVESTIGATOR
affiliation: Adiyaman Training and Research Hospital
name: Mustafa Çukurlu, Dr
role: STUDY_DIRECTOR
References: