louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05490303: HeartGuide: Preliminary Study
Official title: Development of Guidance Algorithms for Acquisition of Echocardiographic Reference Views
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cardiac Disease
Keywords: Echocardiography
Guidance algorithm
Lead sponsor: University Hospital, Bordeaux
Sponsor class: OTHER
Collaborators: name: DESKi
First posted: 2022-08-05
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: Echocardiography is the examination of choice for the study of cardiac pathologies. Interest of echocardiography for other medical specialties has already been demonstrated (intensive care in the case of hemodynamic failure - in intra and extra hospital emergency medicine for the initial assessment of chest pain or dyspnea).

The expansion of echocardiography'use has been catalyzed by miniaturization of echographic systems and decrease in their price. Recently, probes directly connected to a tablet or phone have been developed at a limited cost.

Therefore, it's possible to consider these ultrasound scanners as the new stethoscope that could be used by any health professional.

The last limit to this democratization is the training, especially for non-specialists (non-cardiologists).

Detailed description: Since January 2019, echocardiography laboratory headed by Prof. Stéphane Lafitte and DESKi (start-up - Bordeaux) have been working on guiding non-experts through their cardiac ultrasound examination.

An algorithm indicating in real time if the view obtained corresponds to a reference view has already been validated. However, this algorithm does not tell the operator which movement would improve the image quality.

Thanks to advances in deep learning and by combining cardiac ultrasound acquisitions with systems that record the position of the probes in real time, it would be possible to develop an algorithm able to guide the operator's movements.

Eligibility criteria: Inclusion Criteria:

* Patients (male or female) older than 18 years,
* Patient having a scheduled cardiac ultrasound outside any emergency context,
* Patients who have not objected to participating in the research (at the latest on the day of inclusion and before any examination required by the research),
* Subjects affiliated or benefiting from a social security plan,
* Women of childbearing age who are using effective contraception.

Exclusion Criteria:

* Person under legal protection (legal protection, guardianship or curatorship),
* Person deprived of liberty by judicial or administrative decision,
* Person who is unable to give his/her non-opposition,
* Pregnant or breastfeeding women.

Primary outcomes:
measure: Probe position
timeFrame: Day 0
Secondary outcomes:
measure: Percentage of matches between algorithm and expert
timeFrame: Day 0
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: CHU de Bordeaux
Study officials:
affiliation: University Hospital, Bordeaux
name: Stéphane LAFITTE, MD,PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT02956603: Studying Electromyographic Activity in Patients With Upper Limb Amputations
Official title: Studying Electromyographic Activity in Patients With Upper Limb Amputations
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Amputation, Traumatic
Lead sponsor: University of Michigan
Sponsor class: OTHER
First posted: 2016-11-06
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The primary purpose of this study is to determine the extent to which the Regenerative Peripheral Nerve Interface ( i.e. reinnervation of partial muscle grafts by residual peripheral nerves) enables both the generation of high-performance motor control signals for prosthetic limbs, and the input of sensory percepts by electrical stimulation.


Eligibility criteria: Inclusion criteria:

* For the prosthetic control graft arm:

  * Must have previously undergone upper limb amputation
  * Must be otherwise healthy (e.g. no severe pain syndromes or untreated mental health disorders)
  * Must be American Society of Anesthesiologists (ASA) Class I (low surgical risk)
  * Must have sufficient soft tissue quality to support performance of the operative procedures
  * Must have NOT previously received the partial muscle graft surgery
* For the neuroma graft arm:

  * Must have previously undergone upper limb amputation
  * Must be otherwise healthy (e.g. no severe pain syndromes or untreated mental health disorders)
  * Must have previously received the partial muscle graft surgery
* For the able-bodied arm:

  * Must have NOT undergone upper limb amputation
  * Must be in good health

Exclusion criteria:

* For the prosthetic control graft arm:

  * Participants sustaining severe crushing or avulsion injuries with substantial superficial and deep scarring, may not be appropriate candidates for inclusion in the study
* For the able-bodied arm:

  * Participants with a history of nerve pain may not be appropriate candidates for inclusion in the study

Primary outcomes:
measure: Amplitude of EMG signal
timeFrame: <4 hours
measure: Number of separate sensory percepts evoked
timeFrame: <4 hours
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01755403: Population Pharmacokinetics in Benznidazole-treated Adults With Chronic With Chagas Disease
Official title: Population Pharmacokinetics in Benznidazole-treated Adults With Chronic Chagas Disease. Benznidazole Pharmacokinetics and Adverse Reactions Relationship.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Chagas Disease
Lead sponsor: Barcelona Centre for International Health Research
Sponsor class: OTHER
First posted: 2012-12-24
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: o study population pharmacokinetics in Benznidazole-treated adult patients with Chronic Chagas Disease to get information to optimize drug doses.


Eligibility criteria: Inclusion Criteria:

* Adult patients with Chronic Chagas Disease diagnosed by 2 different and positive serological tests.
* Patients with Chronic Chagas Disease who are going to start treatment with Benznidazole.
* Any gender.
* All the participants must agree to participate in the study and must sign the informed consent.

Exclusion Criteria:

* Patients younger than 18.
* Patients with previous hypersensitivity to Benznidazole.
* Immunocompromised patients as AIDS, cancer, chemotherapy, longterm corticoids need, primary immunodeficiency, or any other.
* Hepatic dysfunction
* Renal dysfunction: serum creatinin higher than 3 mg/dl.
* Pregnancy or lactation.
* Low adhesion to treatment or check-up.
* Impossibility of follow-up.
* Severe adverse reaction to Benznidazole.
* Any other situation that could be risky for the patient.

Primary outcomes:
measure: Population pharmacokinetic parameters of Benznidazole
timeFrame: 2 months (treatment period)
Secondary outcomes:
measure: Adverse reactions
timeFrame: 2 months (treatment period)
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: International Health Department, Hospital Clinic, Barcelona
state: Cataluña
Study officials:
affiliation: Barcelona Centre for International Health Research (CRESIB)
name: Joaquim Gascón, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Aldasoro E, Posada E, Requena-Mendez A, Calvo-Cano A, Serret N, Casellas A, Sanz S, Soy D, Pinazo MJ, Gascon J. What to expect and when: benznidazole toxicity in chronic Chagas' disease treatment. J Antimicrob Chemother. 2018 Apr 1;73(4):1060-1067. doi: 10.1093/jac/dkx516.
citation: Soy D, Aldasoro E, Guerrero L, Posada E, Serret N, Mejia T, Urbina JA, Gascon J. Population pharmacokinetics of benznidazole in adult patients with Chagas disease. Antimicrob Agents Chemother. 2015;59(6):3342-9. doi: 10.1128/AAC.05018-14. Epub 2015 Mar 30.
Clinical trial NCT06051903: Effect of Talar Mobilization With Movement Versus Acupuncture on Knee Pain and Function in the Postmenopausal Women
Official title: Effect of Talar Mobilization With Movement Versus Acupuncture on Knee Pain and Function in the Postmenopausal Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Talar Mobilization Acupuncture
Lead sponsor: October 6 University
Sponsor class: OTHER
First posted: 2023-09-25
Enrollment: 40
Sex: FEMALE
Minimum age (years): 50
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine the effect of talar mobilization with movement versus acupuncture on knee pain and function in the postmenopausal women

Detailed description: A sample of forty postmenopausal women were selected from Department of Gynecology and Obstetrics, Participants were assigned into two groups (group A) postmenopausal women who receive the talar mobilization with movement technique for knee joint , their age raged from 50-60 years (n= 20) and (group B) postmenopausal women who receive acupuncture for knee joint (n= 20), their age ranged from 50-60 years and body mass index (BMI) for both groups were less than 30 kg/m2. All participants were evaluated through measuring knee range of motion by using goniometer and the degree of knee pain by using numeric rating scale and pressure algometer

Eligibility criteria: Inclusion Criteria:

* ) Females patients refered from orthopedic surgeon diagnosed with knee OA (2) Their age ranged from 50 _60 years old 3) Their BMI less than 30 kg/m2. 5) knee pain in the previous week with an intensity of at least 3 points on a numeric pain rating scale (NPRS ) (5) Patients limited ankle dorsiflexion ROM 6) All Patients had 3 points on NPS (7) Presence of knee pain for at least 3 moonths 8) All patients were given the arabic version of KOOS questionnaire

Exclusion Criteria:

* 1) Patients with Rheumatoid arthritis 2) Their BMI more than 30 kg/m2. 3) Unrelated to any traumatic knee event 4) Patients with Previous tibial fracture 5) Patients with Ankle instability 6) Patients with previous meniscal degeneration 7) Patients with hyper laxity 8) Patients with neurological disorders

Primary outcomes:
measure: . Numeric pain rating scale
timeFrame: up to 4 weeks
Secondary outcomes:
measure: KOOS questionnaire
timeFrame: up to 4 weeks
measure: Pressure algometer
timeFrame: up to 4 weeks
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Kerolous Ishak Shehata Kelini
Study officials:
References:
Clinical trial NCT05035303: Can Trajectory Nor-epinephrine Infiltration Reduce Blood Loss During Percutaneous Nephrolithotomy (PCNL)?
Official title: Can Trajectory Nor-epinephrine Infiltration Reduce Blood Loss During Percutaneous Nephrolithotomy?: A Double-blind Randomized Placebo Controlled Study.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Blood Loss, Surgical
Lead sponsor: Benha University
Sponsor class: OTHER
First posted: 2021-09-05
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: during PCNL; A few milliliters of nor-epinephrine is injected into the intended tract after puncture of pelvicalyceal system and before its dilatation compared to injection of saline (placebo). hemoglobin change \& blood loss is estimated and will compared.

Detailed description: All patients of are positioned in lithotomy position and 6 F open tip ureteral catheter is fixed by cystoscope. Then, A pelvicalyceal system is punctured under ultrasound and/or fluoroscopic guidance, then a 18 Gauge (G) puncture needle is introduced toward the desired calyx and a 0.038 inch guide wire is inserted. then 20 G Chiba needle is introduced alongside the puncture needle for infiltration of the whole tract by either a few milliliters of nor-epinephrine or saline. then, the tract is dilated over the guide wire, lastly an Amplatz sheath was inserted.

nephroscope is used for stones disintegration by pneumatic or laser lithotripter . Fragments are washed out or removed by forceps.

Eligibility criteria: Inclusion Criteria:

* renal stones\>2 cm

Exclusion Criteria:

* coagulopathy, congenital anomalies, active Urinary tract infections

Primary outcomes:
measure: hemoglobin drop
timeFrame: 72 hours post intervention
measure: blood loss
timeFrame: immediately after surgery
Secondary outcomes:
measure: stone free rate
timeFrame: within 3 months post-operative
measure: adverse events
timeFrame: within 30 days post-operative
Other outcomes:
Locations:
city: Banha
country: Egypt
facility: Banha University Hospitals
state: Kalubiaya
city: Banhā
country: Egypt
facility: Banha university hospital
state: Qalubia
Study officials:
affiliation: Faculty of medicine, Banha university
name: Waleed El-Shaer
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05950503: Single-center Ambispective Observational Study on the Role of Magnetic Resonance Imaging (MRI) in the Evaluation of Patient Affected by Hepatic Metastases of Carcinoma of the Colorectal Cancer (CRC).
Official title: Single-center Ambispective Observational Study on the Role of Magnetic Resonance Imaging (MRI) in the Evaluation of Patient Affected by Hepatic Metastases of Carcinoma of the
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Colorectal Cancer
Lead sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Sponsor class: OTHER
First posted: 2023-07-18
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Colorectal cancer patients with liver metastases treated at the U.O.C. of Medical Oncology of Foundation Agostino Gemelli University Hospital

Brief summary: This study wants to evaluate the use of MRI in the managemente of mCRC with liver only metastases.


Eligibility criteria: Inclusion Criteria:

* Age \> 18 years;
* Histological diagnosis of colorectal cancer;
* Presence of liver metastases in the staging exams (chest-abdomen CT with contrast medium or PET-CT with 18-FDG);
* At least one measurable liver lesion according to RECIST 1.1 criteria;
* Adequate organ and marrow function.

Exclusion Criteria:

* Age \< 18 years;
* Inability to undergo MRI;
* Major contraindications to liver surgery;
* No written informed consent.

Primary outcomes:
measure: Surgery conversion rates
timeFrame: 3 years
Secondary outcomes:
measure: Overall survival
timeFrame: 3 years
Other outcomes:
Locations:
city: Roma
country: Italy
facility: Policlinico Agostino Gemelli
Study officials:
References:
Clinical trial NCT05749003: Sensorimotor Training Exercise After Lower Extremity Burns
Official title: Effect of Sensorimotor Training Exercise After Lower Extremity Burns, Prospective Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lower Extremity Burns
Keywords: Sensorimotor training
Stability
Mobility
Balance
Burn
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2023-03-01
Enrollment: 60
Sex: ALL
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Burn injury affects dermal tissue which contains sensory neurones that contribute to the conscious and automatic feedback systems which in turn, control balance and coordination. Impediments arising from lower limb burn injuries are similar to those observed in other populations suffering lower limb disease or pathology and further, these complications cause balance dysfunction. Balance and mobility are complex bodily functions integral to discharge disposition, social function and quality of life. Therefore, to guide recovery accurately and facilitate rehabilitation after LLBI, multi-factorial assessment is required.

Detailed description: Burns to the lower limbs can cause pain, scar tissue contracture, impaired sensation, muscle weakness and postural imbalance are all potential complications of lower limb burn injury (LLBI) which negatively influence a person's ability to function normally

Sensorimotor training is a special form of proprioceptive and balance exercise that was designed for management of patients with chronic musculoskeletal pain syndromes. It is based on the concept that instead of emphasizing the isolated strength of a group of muscles around a joint, we should realize the importance of the central nervous system in regulating movement in order to reach proper firing patterns for maintaining joint stability.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of thermal burn injuries at the lower extremities.
* Total body surface area burned approximately from 40 to 50%.
* Patients age: 20 to 50 years.

Exclusion Criteria:

* Cognitive or mentality dysfunctions.
* Psychiatric conditions.
* Fractures.
* Pregnancy.
* Cancer.
* Severe vascular complications.

Primary outcomes:
measure: Stability assessment
timeFrame: 2 months
measure: Balance assessment
timeFrame: 2 months
Secondary outcomes:
measure: Mobility assessment
timeFrame: 2 months
measure: Quality of life (36-Item Short Form Health Survey (SF-36).
timeFrame: 2 months
measure: Muscle Torque assessment
timeFrame: 2 months
Other outcomes:
Locations:
city: Tanta
country: Egypt
facility: Nesma Morgan Allam
Study officials:
affiliation: Assisstant professor of physical therapy for surgery, Faculty of physical therapy
name: Hadaya M Eladl, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT00666003: Hemodynamic Assessment APCO Monitor vs Crit Line for Renal Replacement Rx
Official title: Hemodynamic Assessment Comparison Between Arterial Pressure Cardiac Output Monitor and Crit Line Utilized During Renal Replacement Therapy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Renal Failure
Hemodynamics
Keywords: Hemodynamics
Lead sponsor: Baystate Medical Center
Sponsor class: OTHER
First posted: 2008-04-24
Enrollment: 26
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: Renal Failure Patients in the ICU

Brief summary: Fluid and volume management are a challenging part of critical care and the difficulties increase in the face of renal failure. Utilizing the Crit-Line to monitor blood volume changes in conjunction with arterial pressure cardiac output monitoring may lead to better understanding of the impact fluid removal during dialysis has on hemodynamics.

Detailed description: Patients in an ICU often require large amounts of IV fluid to maintain adequate cardiac function. In patients with renal failure, the ability to gauge adequacy of circulating blood volume based on urine output is obviously lacking. The FDA approved devices called Flotrac/Vigileo and Crit-Line are used in this setting to determine adequacy of fluid resuscitation. This study proposes to use the data collected in a retrospective manner to determine if correlation of the various measured parameters can serve as a predictor of hemodynamic status.

Eligibility criteria: Inclusion Criteria:

* Indwelling arterial catheter
* Require dialysis
* CVP in place
* Use of Crit-Line and Flotrak device

Exclusion Criteria:

* Aortic Regurgitation
* Use of an intra-aortic balloon pump
* Weight less than 90 lbs
* Cardiac arrhythmias

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Springfield
country: United States
facility: Baystate Medical Center
state: Massachusetts
Study officials:
affiliation: Baystate Medical Center
name: Patrick Mailloux, D.O.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01964703: Effect of Rubus Occidentalis Extract on Plasma Glucose Levels in Subject With Prediabetes
Official title: Effect of Rubus Occidentalis Extract on Plasma Glucose Levels in Subject With Prediabetes; A Proof-of-concept, Randomized, Double-blind, Parallel-group Placebo-controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Prediabetes (Impaired Fasting Glucose and/or Impaired Glucose Tolerance)
Lead sponsor: Korea University Anam Hospital
Sponsor class: OTHER
First posted: 2013-10-17
Enrollment: 29
Sex: ALL
Minimum age (years): 19
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 determine whether Rubus occidentalis extract could improve fasting or postprandial serum glucose levels, and related metabolic markers among patients with prediabetes (impaired fasting glucose and/or impaired glucose tolerance).


Eligibility criteria: Inclusion Criteria:

* 19 years of age or older
* prediabetes (fasting plasma glucose 100-125mg/dl, and/or post 75g OGTT plasma glucose 140-199mg/dl)

Exclusion Criteria:

* pregnant women
* taking anti-hyperglycemic agents within 3 months at the time of enrollment
* history of heart failure, myocardial infarction, cerebral infarction
* uncontrolled hypertension (systolic BP \> 160mmHg, or diastolic BP \> 100mmHg)
* serum triglyceride level \> 500mg/dl
* kidney dysfunction (serum Creatinine \> 30% of upper normal limits)
* hepatic dysfunction (AST, ALT \> 3 times of upper normal limits)
* taking systemic glucocorticoids within 1 month

Primary outcomes:
measure: serum glucose (fasting and post 75g oral glucose tolerance test)
timeFrame: 12 weeks
Secondary outcomes:
measure: serum insulin
timeFrame: 12 weeks
Other outcomes:
measure: HOMA IR, QUICKI, HOMA beta, lipid profile, inflammatory markers
timeFrame: 12 weeks
Locations:
Study officials:
References:
citation: An JH, Kim DL, Lee TB, Kim KJ, Kim SH, Kim NH, Kim HY, Choi DS, Kim SG. Effect of Rubus Occidentalis Extract on Metabolic Parameters in Subjects with Prediabetes: A Proof-of-concept, Randomized, Double-blind, Placebo-controlled Clinical Trial. Phytother Res. 2016 Oct;30(10):1634-1640. doi: 10.1002/ptr.5664. Epub 2016 Jun 9.