louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06426862: Effects of Otago Exercise Program in Falls, Balance and Physical Performance in Stroke Patients
Official title: To Determine the Effects of the Otago Exercise Program on the Frequency of Falls, Balance Capabilities, and Overall Physical Performance in Stroke Patients.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Stroke
Keywords: Stroke
Cardiovascular Attack
Otago Exercise Program
Berg Balance Scale
Time Up & Go Test
Fugl-Meyer Assessment
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2024-05-23
Enrollment: 30
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study aims to determine the effects of the Otago Exercise Program (OEP) on falls and balance as well as overall physical performance. Participants will be divided into two groups; control and intervention group. It is a week-long study, the participants will be assessed through the Berg Balance Scale (BBS), Time Up and Go (TUG) and Fugl-Meyer Assessment (FMA).

Detailed description: The previous literature suggested that the Otago exercise showed significant improvement in terms of fall and balance. Most of the Studies were conducted on the elderly population but limited studies are available regarding stroke. This study will look at the effect of Otago exercise on stroke patients. The Otago exercise consists of 17 exercises; strengthening and balancing exercises. The participants will receive Otago exercise and routine physiotherapy treatment for six weeks. The participants will go through three assessments; Baseline Assessment, After 3 weeks assessment and final assessment. For association, a mixed method ANOVA test will be used.

Eligibility criteria: Inclusion Criteria:

* Ischemic or hemorrhagic stroke
* Medically stable patients with acute to subacute level of stroke recovery (\< 6 month).
* Patients 40 plus age
* Berg balance scale \<45 and \>20 score
* TUG test scoring \>20 sec

Exclusion Criteria:

* Participants having cognition problem or language barrier
* Physical disability (fracture or amputation) other than stroke
* Previous surgery 6 weeks
* Cardiovascular and pulmonary disease

Primary outcomes:
measure: Berg Balance Scale
timeFrame: Baseline
measure: Berg Balance Scale
timeFrame: After 3 weeks
measure: Berg Balance Scale
timeFrame: After 6 weeks
measure: Time Up & Go Test
timeFrame: Baseline
measure: Time Up & Go Test
timeFrame: After 3 weeks
measure: Time Up & Go Test
timeFrame: After 6 weeks
measure: Fugl-Meyer Assessment
timeFrame: Baseline
measure: Fugl-Meyer Assessment
timeFrame: After 3 weeks
measure: Fugl-Meyer Assessment
timeFrame: After 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Peshawar
country: Pakistan
facility: Muhammad Baqir
state: KPK
Study officials:
affiliation: Riphah International University
name: IMRAN AMJAD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05510362: Management and Short Term Outcome of Traumatic Wounds in the Emergency Department
Official title: Management and Short Term Outcome of Traumatic Wounds in the Emergency Department
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Wound Heal
Keywords: wounds
superinfections
stitches
Lead sponsor: University of Monastir
Sponsor class: OTHER
First posted: 2022-08-22
Enrollment: 3000
Sex: ALL
Minimum age (years): 1
Maximum age (years): 90
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients with an acute suturable wound and accept to enroll the study .

Brief summary: Identify the risk factors for complications as well as study the evolution of wounds sutured in the emergency room towards complications such as superinfections, necrosis, disunity of the stitches linked to inadequate initial care.

Detailed description: All traumatic injuries should be considered contaminated upon presentation to the emergency room. This is why the main objective of this study was to describe the attitude of patients towards their wounds, to identify the risk factors for complications as well as to study the evolution of sutured wounds in the emergency room towards complications such as superinfections, necrosis, disunity of stitches linked to inadequate initial treatment.

This is a prospective, observational, monocentric study carried out in the emergency services of the Fattouma Bourguiba hospital in Monastir.

Eligibility criteria: Inclusion Criteria:

* Patients who presented to the ambulatory emergency circuit of the EPS Fattouma Bourguiba Monastir having as main reason for consultation an acute suturable wound.

Exclusion Criteria:

* Wounds requiring surgical treatment
* Septic wounds
* Chronic lesions
* Vascular wounds
* Patients who did not consent to the protocol.

Primary outcomes:
measure: Evolution of the wound and the healing period.
timeFrame: day 10
Secondary outcomes:
Other outcomes:
Locations:
city: Monastir
country: Tunisia
facility: Nouira
Study officials:
affiliation: CHU Fattouma Bourguiba Monastir, service des urgences
name: Bel Haj Ali A Khaoula, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT04300062: Tumor Rebiopsy During Progression Under Immunotherapy for Patients With Lung Cancer
Official title: Tumor Rebiopsy During Progression Under Immunotherapy for Patients With Lung Cancer
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Lung Cancer
Keywords: lung cancer
rebiopsy
immunotherapy
progression
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2020-03-09
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The objective of the study aims to collect tumor tissue at the moment of progression under Immune checkpoint inhibitors (ICI) in biological resources center in Ambroise Paré hospital, in order to insure later study on molecular mechanism involving the progression of NSCLC and SCLC under ICI.

The further analysis of research will be performed in the EA 4340 unity, Biomarkers and Clinical Trials in cancerology and onco-hematology, UVSQ, University of Paris-Saclay.

Detailed description: The study will consist of creation a tumor tissue bank, all sampling will be stored in the biological resources center of Ambroise Paré hospital.

Eligibility criteria: Inclusion Criteria:

* Diagnosed NSCLC or SCLC;
* Patient treated priorly by ICI and progressed under ICI;
* Have provided written informed consent for the study;
* Be \>/= 18 years of age on day of signing informed consent.

Exclusion Criteria:

* Patient under guardianship or curatorship;
* Unable to provide written informed consent for the study;
* Technical impossibility to carry out tissular rebiopsy under local anesthesia.

Primary outcomes:
measure: Incidence of specific histomolecular resistance
timeFrame: At the end of study, up to 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Boulogne-Billancourt
country: France
facility: Service de Pneumologie et Oncologie thoracique, Hôpital Ambroise Paré, APHP
Study officials:
affiliation: Service de Pneumologie et Oncologie thoracique, Hôpital Ambroise Paré, APHP
name: Etienne Giroux Leprieur, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Giroux Leprieur E, Dumenil C, Julie C, Giraud V, Dumoulin J, Labrune S, Chinet T. Immunotherapy revolutionises non-small-cell lung cancer therapy: Results, perspectives and new challenges. Eur J Cancer. 2017 Jun;78:16-23. doi: 10.1016/j.ejca.2016.12.041. Epub 2017 Apr 11.
Clinical trial NCT02061462: EVLP to Evaluate the Eligibility for Transplantation of DCD-Lungs
Official title: Extracorporeal Lung Perfusion and Ventilation to Evaluate the Eligibility for Transplantation of Lungs Retrieved From Donors After Cardio-circulatory Death (DCD)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Disorders Related to Lung Transplantation
Graft Failure
Lead sponsor: Policlinico Hospital
Sponsor class: OTHER
Collaborators: name: San Gerardo Hospital
First posted: 2014-02-12
Enrollment: 10
Sex: ALL
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: The procurement of organs from donors after cardiocirculatory death (DCD) is an accepted strategy to increase organ supply.

Detailed description: Aim of the investigation: to compare the clinical outcome after transplantation of subjects receiving lungs procured from donors after cardiocirculatory death reconditioned and assessed by EVLP, with that of subjects receiving lungs procured from brain death donors.

Eligibility criteria: Lung donors:

* subjects with brain death according to neurological or cardiocirculatory criteria
* age below 65 yrs
* absence of massive lung contusion, aspiration, pneumonia, sepsis
* absence of infection, malignancy

Recipients:

* subjects to undergo single or bilateral lung transplantation
* informed consent to participate in the study

Primary outcomes:
measure: 30 Day Mortality and Graft Survival
timeFrame: 30 days
Secondary outcomes:
measure: Duration of mechanical ventilation after transplantation
timeFrame: 30 days
measure: ICU length of stay after transplantation
timeFrame: 30 days
measure: Primary Graft Dysfunction 72 hours After Transplantation
timeFrame: 72 hours
Other outcomes:
measure: Bronchiolitis Obliterans Syndrome (BOS)
timeFrame: 12 months
Locations:
city: Milan
country: Italy
facility: Fondazione IRCCS a' Granda - Ospedale Maggiore Policlinico
Study officials:
affiliation: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
name: Franco Valenza, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03133962: Evaluation of the Contribution of the Ultrasound Tracking and the Positioning of the Distal End During the Implantation of Implantable Chamber or Long-lasting Venous Catheter
Official title: Evaluation of the Contribution of the Ultrasound Tracking and the Positioning of the Distal End During the Implantation of Implantable Chamber or Long-lasting Venous Catheter
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Echocardiography
Implantable Chamber
Lead sponsor: Centre Hospitalier Universitaire, Amiens
Sponsor class: OTHER
First posted: 2017-04-28
Enrollment: 0
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: Given the increase in the number of PAC implants or long-term catheters, and the ease of access to cardiac ultrasound in the operating theaters, the investigator thought to use ultrasound to PAC or long-term catheters.

The investigator considers cardiac echocardiography through its costal pathway to locate the correct positioning of the distal end of the catheter in a manner equivalent to the scopic locating with all the side effects of the irradiation and with Equivalent efficiency


Eligibility criteria: Inclusion Criteria:

* All adult patients are candidates for a long-term CAP or central catheter placement.
* Benefiting from sedation or general anesthesia.

Exclusion Criteria:

* Patient aged \<18 years.
* Pregnant woman.
* Lack of anesthesiologist with knowledge of ultrasound.
* Site of femoral puncture

Primary outcomes:
measure: Good positioning of the distal end of the catheter by ETT, without repositioning following the scopy
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Amiens
country: France
facility: CHU Amiens Picardie
state: Picardie
Study officials:
References:
Clinical trial NCT01112462: To Test Bioequivalence Between Two Formulations of Paracetamol/Phenylephrine
Official title: A Single-dose, Randomized, Crossover Bioequivalence Study to Compare Two Formulations of Paracetamol/Phenylephrine
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Respiratory Tract Infections
Keywords: Nasal congestion, Headache
Lead sponsor: Johnson & Johnson Consumer and Personal Products Worldwide
Sponsor class: INDUSTRY
First posted: 2010-04-28
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: This study is designed to assess bioequivalence between two paracetamol/ phenylephrine combination products.

Detailed description: The study will be a single dose, randomized, two-way crossover study in 40 healthy subjects, with equal numbers of males and females. Drop-outs will not be replaced. The two doses of medication given in the study (a single dose in each of the two study periods) will be separated by a washout period of at least 7 days. In each study period, sixteen blood samples for pharmacokinetic analysis will be taken over 24 hours. Blood samples will be centrifuged and concentrations of paracetamol and phenylephrine in plasma will be measured using a validated chromatographic assay. Pharmacokinetic parameters will be calculated from plasma concentration data. The rate and extent of absorption of the formulations will be compared.

Eligibility criteria: Inclusion Criteria:

* Healthy male and female
* Caucasians
* Aged between 18 and 50 years
* BMI ≤ 30 kg/m2
* Clinically normal medical history
* Physical normal examination
* Normal laboratory test results

Exclusion Criteria:

* Pregnancy, lactation or intended pregnancy
* Hypersensitivity to or intolerant of the study medications
* Donation or loss of blood within 90 days preceding the first dose of study medication

Primary outcomes:
measure: Pharmacokinetic measurements
timeFrame: during 24 hours following drug administration
Secondary outcomes:
Other outcomes:
Locations:
city: Cork
country: Ireland
facility: Shandon Clinical Trials Ltd.
Study officials:
affiliation: McNeil AB
name: Elisabeth Kruse, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT01131962: Comparing Two Methods to Stop Vomiting of Blood Using the Endoscope
Official title: Control of Acute Variceal Bleeding Using the Multi-shooter Band Ligator Compared to Injection Sclerotherapy.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hematemesis
Portal Hypertension
Keywords: esophageal varices
hematemesis
endoscopy
Lead sponsor: University of Alexandria
Sponsor class: OTHER
First posted: 2010-05-27
Enrollment: 200
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: Band ligation and injection sclerotherapy are two modalities of treatment that are applied using the endoscope. The purpose of this study is to determine which of two methods is better for controlling bleeding from the upper gut.

Detailed description: The use of band ligation for endoscopy during the attack of hematemesis is a novel practice as opposed to injection sclerotherapy.

Eligibility criteria: Inclusion Criteria:

* Active hematemesis
* esophageal varices

Exclusion Criteria:

* Hemodynamic unstability
* Hepatic coma or precoma
* Tense ascitis
* Coagulopathies
* concomitant gastric varices

Primary outcomes:
measure: control of hematemesis
timeFrame: 72 hours
Secondary outcomes:
measure: occurence of complications from the intervention
timeFrame: 30 days
Other outcomes:
Locations:
city: Alexandria
country: Egypt
facility: Hematemesis unit, Alexandria Main University Hospital, Azarita
Study officials:
affiliation: University of Alexandria
name: Yasser Hamza, A Prof
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04831762: Markers of Executive Attention Development in Preschoolers - Behavioral Measures in Various Populations
Official title: MARQUEURS DE DEVELOPPEMENT DE L'ATTENTION EXECUTIVE CHEZ L'ENFANT : POPULATIONS VARIEES
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Attention Deficit
Lead sponsor: University Hospital, Caen
Sponsor class: OTHER
First posted: 2021-04-05
Enrollment: 200
Sex: ALL
Minimum age (years): 48
Maximum age (years): 71
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Preschoolers 48 to 71 months of age.

Brief summary: Executive attention is essential for emotional and behavioral self-regulation. There is inter-individual variability in the level of efficiency of executive attention from kindergarten entry, and this variability predicts children's academic performance at entry to elementary school and beyond. It is therefore essential to better understand the early stages of executive attention development and self-regulation from an early age in order to develop tools for early detection of executive attention disorders, so that school accommodations can be proposed as early as possible.

In previous work, we have identified early tactile information processing skills that underpin the development of executive attention. We would like to extend this work to a diverse population of preschool children, in order to consider new tools for the early detection of attention disorders. The MEDiATE-PRV project aims to compare the performance obtained in a validated attentional task in preschool children with assessments of tactile information processing, in relation to the psychomotor and executive development of the child. We will include 200 children aged 4 years to 5 years 11 months with different risk factors for ADHD.


Eligibility criteria: Inclusion Criteria:

* Attending preschool
* Parental informed consent

Exclusion Criteria:

- None

Primary outcomes:
measure: ANT performance
timeFrame: 48 to 71 months of age
measure: Tactile processing score
timeFrame: 48 to 71 months of age
Secondary outcomes:
Other outcomes:
Locations:
city: Caen
country: France
facility: Comete U1075 Inserm Unicaen
Study officials:
References:
Clinical trial NCT01150162: Mucosta in Gastric Ulcer Treatment, Effectiveness and Safety Evaluation
Official title: A Prospective Randomized, Multi-center Study to Assess the Safety and Efficacy of Mucosta (Rebamipide), in Combination With Omeprazole as Adjuvant Therapy in Gastric Ulcer Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Gastric Ulcer
Lead sponsor: Otsuka Pakistan Limited
Sponsor class: INDUSTRY
First posted: 2010-06-24
Enrollment: 129
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A Prospective Randomized, Multi-center study to assess the Safety and Efficacy of Mucosta (Rebamipide), in combination with Omeprazole as adjuvant therapy in Gastric Ulcer Patients.


Eligibility criteria: Inclusion Criteria:

* Patients with dyspepsia or epigastric pain and endoscopically proven gastric and duodenal ulcers
* Required laboratory parameters and time limits (screening blood tests will be taken including hemoglobin, white blood cell count, random glucose, potassium, sodium, chlorine, creatinine, AST, ALT, bilirubin, and alkaline phosphatase)
* Age \> 18 years
* A statement that all patients must have signed an informed consent form prior to registration in study

Exclusion Criteria:

* Patients who had undergone surgery for ulcers
* History of hypersensitivity to drugs to be used in the study
* Women who are pregnant or lactating or intended to get pregnant during the study period

Primary outcomes:
measure: Healing rates for gastric ulcer patients via endoscopic examination
timeFrame: 8 weeks treatment plus 4 weeks follow-up
measure: Improvement or absence of gastric ulcer associated symptoms
timeFrame: 8 weeks treatment plus 4 weeks follow-up
Secondary outcomes:
measure: To determine and compare the Safety profile in both the treatment arms.
timeFrame: 8 weeks treatment plus 4 weeks follow-up
Other outcomes:
Locations:
city: Karachi
country: Pakistan
facility: Abbasi Shaheed Hospital
city: Karachi
country: Pakistan
facility: Dow University of Health Sciences
city: Karachi
country: Pakistan
facility: Dr. Ziauddin University Hospital
Study officials:
affiliation: Dr. Ziauddin University Hospital
name: Dr. Laeeque Ahmed, Asst. Professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02867462: Information Consultation by Radiotherapy Manipulator
Official title: Information Consultation by a Manipulator Radiotherapy: Impact on Information to Patients Treated With Radiotherapy for Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cancer
Lead sponsor: Centre Antoine Lacassagne
Sponsor class: OTHER
First posted: 2016-08-16
Enrollment: 308
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The medical teams are increasingly sought by patients to get the most possible information, probably expressed in a different form and thereby supplementing the information already received. Coulter et al. reached similar conclusions in their study of the writings of patient information documents. They point out, moreover, the best adaptation of the patients better informed compared to those with less or no information.

This need for information varies over time. It is present before treatment begins, continues during treatment and persists after treatment. Given the specific features of radiotherapy, the manipulators are important interlocutors to participate in the accompanying caregiver time.

In conclusion, the quality of information delivered to the patient has been poorly evaluated, let alone with validated tools in this area.

The impact of information on the tolerance of the treatment also needs to be confirmed, knowing that an informed patient seems less anxious and better prepared for future treatment.


Eligibility criteria: Inclusion Criteria:

* Patients with cancer of the head and neck, esophagus, stomach, breast, rectum, anal canal, prostate, lung, bile duct, pancreas or female genital histologically proven
* Patient being treated by radiotherapy alone or combined with chemotherapy / immunotherapy, exclusive treatment or adjuvant
* Age over 18 years

Exclusion Criteria:

* Patient has been treated with radiation to the tumor site
* Patient with metastatic stage disease
* Patient targeted for hypofractionated radiotherapy

Primary outcomes:
measure: EORTC QLQ-INFO25
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Nice
country: France
facility: Centre Antoine LACASSAGNE
Study officials:
affiliation: Centre Antoine Lacassagne
name: Karen BENEZERY, md
role: PRINCIPAL_INVESTIGATOR
References: