louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04826289: Vertical Distance Between Medial and Lateral Malleolus in Normal Population
Official title: Radiological Assessment of Vertical Distance Between Medial and Lateral Malleolus in Normal Population
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Ankle Fractures
Keywords: Radiological standard f ankle fixation
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2021-04-01
Enrollment: 580
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Prospective cross sectional study

Brief summary: Determine variation in vertical distance between the medial and lateral malleolus in the normal population subjected to X-rays for any other causes than ankle fracture Determine the effect of weight bearing on this variation

Detailed description: There is gap of knowledge about determination of vertical distance between medial and lateral malleolus Our research will cover this gap of knowledge ,so our research question will be what is the normal variation of vertical distance between medial and lateral malleolus Fractures of ankle are common injuries,approximately 2% of the general population will sustain an ankle fracture during their life time .many can be successfully treated non operatively However,for those injuries that require surgical intervention ,restoration of the anatomy is the main principle The importance of anatomic restoration of the fibula ,specially in preserving normal length has been appreciated by several authors Data will be obtained from measuring the vertical distance between lateral and medial malleolus in AP view of ankle in traumatic non ankle fractured people in standing and non standing position

Eligibility criteria: Inclusion Criteria:

* non ankle fractured people Non arthritic ankle Age more than 18 years old Non diabetic people Normal ankle X-rays as determined by tibiocrural angle and tibiofibular overlap

Exclusion Criteria:

* people with fracture ankle (United \&non United) Arthritic ankle Diabetic people Abnormal ankle X-rays

Primary outcomes:
measure: Vertical distance between medial and lateral malleolus Radiologically
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Michael Lotfy Makin
Study officials:
affiliation: Resident of orthopedic surgery at assiut university
name: Michael Lotfy
role: STUDY_CHAIR
References:
Clinical trial NCT03996889: Treatment of Popliteal Aneurysms With VIABAHN Stent Graft in Elective Surgery
Official title: Treatment of Popliteal Aneurysms With VIABAHN Stent Graft in Elective Surgery: Multicenter Prospective Registry of the Research in Vascular Surgery University Association (AURC)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Popliteal Aneurysm
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2019-06-25
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The study population will include all popliteal aneurysm patients treated with GORE VIABAHN® stent graft in scheduled elective surgery, whether symptomatic or asymptomatic.

Brief summary: This multicentric, prospective study will evaluate the medium-term outcomes of patients implanted with GORE VIABAHN® stent grafts for popliteal artery aneurysms in scheduled elective surgery with the registry of the Research in Vascular Surgery University Association (AURC)


Eligibility criteria: Inclusion Criteria:

* \> 18 years old at time of treatment
* symptomatic or asymptomatic popliteal artery aneurysm needing surgery
* scheduled elective surgery

Exclusion Criteria:

* life expectancy of \<1 year
* thrombotic occlusion of popliteal artery
* intolerance to antiplatelet drugs (antiaggregants)
* known allergies to GORE VIABAHN® stent graft materials/composition
* emergency surgery

Primary outcomes:
measure: Major limb events
timeFrame: 2 years of follow-up
Secondary outcomes:
Other outcomes:
Locations:
city: Bron
country: France
facility: Hôpital pneumologique et cardiovasculaire Louis Pradel (HCL)
Study officials:
References:
Clinical trial NCT00306189: A Randomized, Double-blind, Placebo-controlled, Dose Response Study of AMG 162 (Denosumab) in Japanese Postmenopausal Osteoporotic Subjects
Official title: Dose Response Study of AMG 162 (Denosumab) in Subjects With Osteoporosis - A Randomized, Double-blind, Placebo-controlled, Dose Response Study of AMG 162 (Denosumab) in Japanese Postmenopausal Osteoporotic Subjects -
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Osteoporosis
Keywords: RANKL
RANK
denosumab
AMG 162
osteoporosis
bone turnover
bone mineral density
Japanese
Lead sponsor: Amgen
Sponsor class: INDUSTRY
First posted: 2006-03-23
Enrollment: 212
Sex: FEMALE
Maximum age (years): 80
Standard ages: CHILD
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 assess the effect of AMG 162 (denosumab) treatment on the lumbar spine BMD at month 12 and safety profile across the dose range tested (14, 60 and 100 mg SC once every 6 months) in Japanese postmenopausal osteoporotic subjects compared with those treated with placebo over 12 months.


Eligibility criteria: Inclusion Criteria: - Ambulatory postmenopausal women. - BMD values (g/cm2, Hologic) must be lower than 0.714 at lumbar spine, 0.515 at femoral neck, 0.588 at total hip. - BMD values must not be lower than 0.535 at the lumbar spine, 0.406 at the femoral neck and 0.478 at the total hip. Exclusion Criteria: - Oral bisphosphonate treatments, PTH or PTH derivatives use within the last 12 months and administration of any of anti-osteoporotic treatments within the last 3 months before initial administration of the investigational product. - History of hypocalcemia. - More than two moderate vertebral fractures or any severe vertebral fracture.

Primary outcomes:
measure: Lumbar Spine Bone Mineral Density Percent Change From Baseline at Month 12
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Amgen
name: MD
role: STUDY_DIRECTOR
References:
citation: Nakamura T, Matsumoto T, Sugimoto T, Shiraki M. Dose-response study of denosumab on bone mineral density and bone turnover markers in Japanese postmenopausal women with osteoporosis. Osteoporos Int. 2012 Mar;23(3):1131-40. doi: 10.1007/s00198-011-1786-8. Epub 2011 Sep 17.
Clinical trial NCT03302689: Comparison Levobupivacaine and Ropivacaine for TAP-block After Caesarean Section
Official title: The Double-blind, Randomized Controlled Trial: Comparison of Levobupivacaine and Ropivacaine for Postoperative Analgesia TAP-block After Caesarean Section
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pain, Postoperative
Keywords: TAP-block
VAS of pain
Cesarean section
Postoperative analgesia
Lead sponsor: Tver Regional Perinatal Center
Sponsor class: OTHER
First posted: 2017-10-05
Enrollment: 50
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Two groups of women after cesarean section under spinal anesthesia
Primary purpose: TREATMENT

Brief summary: Randomized, double-blind, controlled trial: a comparison of Levobupivacaine and Ropivacaine for postoperative analgesia using TAP-block

Objectives:

1. VAS score during the first 12 hours
2. Determine which drug is more effective for postoperative analgesia in the first 12 hours after surgery
3. Side effects

Detailed description: For TAP-block was used Hirokain® (Levobupivacaine) . Injectable solution 7.5 mg / ml; ampoule polypropylene 10 ml, a pack of cardboard 10; No. ЛП-003106, 2015-07-21 to 2020-07-21 from EbbVi Ltd. (Russia); manufacturer: Kurida AS (Norway); Packer: AbbVi S.r.l. (Italy), or Ropivacaine Kabi (Ropivacaine Kabi) (Ropivacaine) Solution for injection 7.5 mg / ml; ampoule polypropylene 1 10 ml, a pack of cardboard 5; EAN code: 4607085481524; No. ЛП-002897, 2015-03-04 to 2020-03-04 from Fresenius Kabi Deutschland GmbH (Germany); manufacturer: Fresenius Kabi Norge (Norway).

Both preparations were diluted to a volume of 50 ml, at a concentration of 3 mg / ml.

It was performed by TAP-block in-plain with a 22G needle Quincke, on both sides, and 25 ml on each side was injected.

The pain syndrome was assessed with admission, and every 2 hours during the first 12 hours after the operation, using a digital scale on the VAS.

All patients received NSAIDs (Ketorol 3 mg IV every 6 hours from admission)

Additionally:

Paracetamol IV infusion 100 ml with VAS = 4 score, lockout time 6 hours Tramadol 5% - 2 ml IM with VAS = or \> 5 score, lockout time 6 hours

Eligibility criteria: Inclusion Criteria:

* Cesarean section pfannenstiel incision under spinal anesthesia
* Spinal anesthesia with Bupivacaine heavy 0,5%
* Without any adjuvants

Exclusion Criteria:

* Any other anesthesia exept spinal
* Any other surgical incision

Primary outcomes:
measure: Level of pain
timeFrame: 12 hours
Secondary outcomes:
measure: The need for additional analgesics (Paracetamol, Tramadol)
timeFrame: 12 hours
Other outcomes:
Locations:
city: Tver
country: Russian Federation
facility: Tver Regional Perinatal Center
Study officials:
References:
Clinical trial NCT02464189: Assessment of Asthma Knowledge Perception in Parents of Asthmatic Children. Pilot Study by Means of Q-KAP ( Questionnaire on Knowledge, Attitudes and Practices )
Official title: Assessment of Asthma Knowledge Perception in Parents of Asthmatic Children. Pilot Study by Means of Q-KAP ( Questionnaire on Knowledge, Attitudes and Practices )
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Asthma
Lead sponsor: Istituto per la Ricerca e l'Innovazione Biomedica
Sponsor class: OTHER
First posted: 2015-06-08
Enrollment: 390
Sex: ALL
Minimum age (years): 5
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 390 asthmatic children, recruited in the outpatient clinic of Pediatric Allergology \& Pulmonology (PAP) of Respiratory Disease Research Center (RDRC) within the Institute of Biomedicine and Molecular Immunology (IBIM) of the National Research Council (CNR) of Palermo (RDRC-IBIM CNR), Italy.

Brief summary: The aim of this study is to assess the knowledge, the attitudes and the practices of parents of asthmatic children.

Detailed description: The aim of this study is to assess the knowledge, the attitudes and the practices of parents of asthmatic children.

The study proposes the validation of Q- KAP by means of the recruiting of 390 parents of asthmatic children, recruited in the outpatient clinic of Pediatric Allergology \& Pulmonology (PAP) of Respiratory Disease Research Center (RDRC) within the Institute of Biomedicine and Molecular Immunology (IBIM) of the National Research Council (CNR) of Palermo (RDRC-IBIM CNR), Italy.

Q-KAP will be given to one of the parents during their children medical examination. Q-KAP is a multiple answer questionnaire investigating on knowledge, attitudes and practices for what concerns Asthma.

At the end of the recruitment time, data will be stored and analyzed in a dataset.

The expected result is the identification of a tool able to assess knowledge, attitudes and practices of asthmatic children parents, but also the identification of a tool able to identify two groups of parents (well-experienced and bad-experienced) to assess if there is a link between a low degree of knowledge and a bad control of the disease.

Eligibility criteria: Inclusion Criteria:

* Asthma

Exclusion Criteria:

* No consent by parents

Primary outcomes:
measure: Knowledge, attitudes and practices of parents of asthmatic children assessment.
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Palermo
country: Italy
facility: Institute of Biomedicine and Molecular Immunology, IBIM
Study officials:
References:
Clinical trial NCT01413789: Measurement and Comparison of the Occlusive and Hydrating Capacity of Three Silicone Gels and One Gel Cream
Official title: Measurement and Comparison of the Occlusive and Hydrating Capacity of Three Silicone Gels: BAP Scar Gel, Dermatix, Kelocote and One Gel- Cream: Alhydran
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Scar Tissue or Healthy Skin
Lead sponsor: University Hospital, Ghent
Sponsor class: OTHER
First posted: 2011-08-10
Enrollment: 55
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Study hypothesis: Is Alhydran gel-cream as efficient as silicone gel for skin occlusion and hydration?

For this study 16 volunteers and ten patients with healed full thickness burns will be included.

After a short period of acclimatization four test areas will be determined. For healthy volunteers the standard zones are located on the inner forearm, two on each forearm.

For patients with healed burns the 4 test zones are located on either the healed donor site or the healed skin grafted area.

In each test zone baseline measurements will be taken before application of the products.After application of the three silicone gels and the hydrating gel cream the trans epidermal water loss (TEWL) and the moisture content of the stratum corneum will be measured by using the TEWAmeter®TM300 and the Corneometer® CM825 (Courage \& Khazaka).


Eligibility criteria: Inclusion Criteria:

* healthy volunteers or patients with healed full thickness burns and donor sites
* not pregnant
* age\>18 years
* male or female
* written authorisation of the patient or volunteer is required.

Exclusion Criteria:

-

Primary outcomes:
measure: The occlusive and hydrating capacity of the products.
timeFrame: 1 hour after application
Secondary outcomes:
measure: The occlusive and hydrating capacity of the products.
timeFrame: 2 hours after application
measure: The occlusive and hydrating capacity of the products.
timeFrame: 3 hours after application
Other outcomes:
Locations:
city: Ghent
country: Belgium
facility: University Hospital
Study officials:
affiliation: University Hospital, Ghent
name: S. Monstrey, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06118489: Effects of Different Anesthetic Gases on Hemodynamics, Arterial Oxygenation and Pulmonary Mechanics
Official title: Evaluation of the Effects of Different Anesthetic Gases on Hemodynamics, Arterial Oxygenation and Pulmonary Mechanics in Spinal Surgery.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Oxygenation
Spinal Surgery
Sevoflurane
Desflurane
Lead sponsor: Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey
Sponsor class: OTHER
First posted: 2023-11-07
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: ASA 1-2 patients between the ages of 18 and 65 who are scheduled for spinal surgery will be included in the study.

Brief summary: The bronchodilator effects of volatile anesthetics have been the subject of many clinical studies. It is known that all volatile anesthetics, especially halothane, have similar effects. Sevoflurane has been shown to reduce airway resistance more than halothane and isoflurane. Desflurane is difficult to use as an induction agent due to its harsh and extremely pungent odor and airway irritating effect. However, it has been shown that the risk of cough, respiratory arrest and laryngospasm is no different from sevoflurane when administered after intravenous induction. Although it irritates the airway, it is thought to have a bronchodilation effect as it stimulates the sympathetic system.

In spinal surgeries, prone position is required to access the operating field. When the patient is placed in the prone position, pulmonary physiology are affected. In the prone position, V/Q mismatch decreases and arterial oxygenation increases. However, lung compliance decreases and the peak inspiratory pressure required to reach the required tidal volume increases. The main purpose of this study is the effect of volatile agents on lung mechanics and oxygenisation in the prone position.


Eligibility criteria: Inclusion Criteria:

* 18-65 years old
* ASA1-2
* Patients planned to undergo spinal surgery

Exclusion Criteria:

* 1 - Lung disease
* BMI 35 and above
* Smokers
* Those under the age of 18 and over the age of 65
* Hepatorenal disease
* Reynaud's disease
* Burger disease
* Hypotensive patient
* Neuromuscular disease
* Those who have had thoracic surgery before
* Those with bad Allen test results

Primary outcomes:
measure: compliance
timeFrame: 2 hour
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Yadigar Yılmaz
Study officials:
References:
Clinical trial NCT04159844: Evaluation of the Stiffness and Pressure Applied on the Lower Leg by a New Compression Bandage on Healthy Subjects
Official title: Evaluation of the Stiffness and Pressure Applied on the Lower Leg by a New Compression Bandage on Healthy Subjects
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Healthy Subjects
Lead sponsor: Laboratoires URGO
Sponsor class: INDUSTRY
First posted: 2019-11-12
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 3 separate sets :

* URGOBD001 SSI compared with the SSI of a short stretch bandage
* URGOBD001 SSI associated with wading bandage compared with the SSI of a short stretch bandage
* URGOBD001 SSI compared with the SSI of a multi component bandage.
Primary purpose: OTHER

Brief summary: This study evaluates the stiffness and interface pressures of a new compression system URGOBD001 on healthy subjects, compares with a short stretch bandage and a multi component bandage.

Detailed description: Compression therapy is widely used in the treatment of chronic venous leg ulcers (VLUs). The clinical performance of a compression system depends on the apply pressure and the stiffness.

The static stiffness index (SSI) is defined by the difference in interface pressure measured when the subject is standing (working pressure) and the interface pressure measured when the subject is in the lying position (resting pressure).

Eligibility criteria: Inclusion Criteria:

* Subject with a body mass index of less than 30 (BMI = kg / m²),
* Subject presenting a healthy skin on both legs without any sign of dermatological lesion,
* Subject presenting a venous doppler of the lower limbs without detectable anomaly
* Subject with a ankle brachial pressure index (ABPI) greater than 0.9 and less than 1.3 for each of the lower limbs,
* Subject accepting to wear a compressive system on both legs for a period of three days.

Exclusion Criteria:

* Subject with chronic venous insufficiency whose stage is greater than or equal to 2 (CEAP classification of chronic venous diseases)
* Subject with type I or II diabetes
* Subject with lipoedema and / or dismorphic leg
* Subject presenting ankle ankylosis

Primary outcomes:
measure: SSI(Static Stiffness Index) ≥ 10 mmHg
timeFrame: Hour 48 after the application
Secondary outcomes:
measure: SSI (Static Stiffness Index)
timeFrame: From Hour 0 (Baseline) to Hour 72 (end of study) after application
measure: Interface pressure under the bandage
timeFrame: From Hour 0 (Baseline) to Hour 72 after application
measure: Slippage of the bandage in cm
timeFrame: From Hour 0 (Baseline) to Hour 72 (end of study) after application
Other outcomes:
Locations:
city: Paris
country: France
facility: Intertek France Clinical studies
Study officials:
affiliation: Intertek France clinical studies
name: Benigni JP, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06311344: Filling Key Research Gaps With Clinical Implications in Mansonellosis and Schistosomiasis: a Network Approach
Official title: Filling Key Research Gaps With Clinical Implications in Mansonellosis and Schistosomiasis: a Network Approach
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Schistosoma Mansoni
Lead sponsor: IRCCS Sacro Cuore Don Calabria di Negrar
Sponsor class: OTHER
First posted: 2024-03-15
Enrollment: 200
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: This is an experimental, multicenter, non-profit study promoted by the Department of Infectious and Tropical Diseases of the IRCCS (Istituto di Ricerca e Cura a carattere scientifico) Sacro Cuore Don Calabria of Negrar which aims to evaluate the presence of endosymbiont Wolbachia in circulating microfilariae obtained from biological samples of individuals infected with M .perstans and the presence of infection with hybrid Schistosoma species in the population of Schistosoma eggs isolated from biological samples of patients with active schistosomiasis.


Eligibility criteria: Inclusion criteria:

* samples from patients who gave consent to the storage and use for research purposes of their samples. In the case a network centre necessitates a template for the storage and use for research purposes of their samples;
* samples collected before any treatment with praziquantel and/or benzimidazole and/or avermectin and/or diethylcarbamazine and/or doxycycline drug;
* samples collected and stored in conditions suitable for this study (Annex 2);
* known country of birth of the patient or of most likely infection (if different from the country of birth)

Exclusion criteria:

- no compliance with at least one of the above-mentioned inclusion criteria.

Primary outcomes:
measure: Number of M. perstans microfilariae
timeFrame: Baseline
measure: Percentage of M. perstans microfilariae
timeFrame: Baseline
measure: Number of Schistosoma eggs
timeFrame: Baseline
measure: Percentage of Schistosoma eggs
timeFrame: Baseline
Secondary outcomes:
measure: Number of samples positive for Wolbachia
timeFrame: Baseline
measure: Percentage of samples positive for Wolbachia
timeFrame: Baseline
measure: Number of samples positive for Schistosoma hybrid species
timeFrame: Baseline
measure: Percentage of samples positive for Schistosoma hybrid species
timeFrame: Baseline
measure: Identification of hybrid species of Schistosoma spp.
timeFrame: Baseline
Other outcomes:
Locations:
city: Negrar
country: Italy
facility: IRCCS Sacro Cuore Don Calabria hospital
state: Verona
Study officials:
References: