louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06561672: Paracetamol Plus Tramadol Versus Fentanyl As Preemptive Analgesia For Enhanced Recovery After Day Case Surgeries
Official title: Paracetamol Plus Tramadol Versus Fentanyl As Preemptive Analgesia For Enhanced Recovery
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: EARLY_PHASE1
Conditions: Preemptive Paracetamol Plus Tramadol and Preemptive Fentanyl
Keywords: paracetamol ,tramadol , fentanyl, day case surgeries
Lead sponsor: Zagazig University
Sponsor class: OTHER_GOV
First posted: 2024-08-20
Enrollment: 102
Sex: ALL
Minimum age (years): 21
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Implementation of enhanced recovery in day case surgeries using either preemptive intravenous paracetamol plus tramadol or preemptive intravenous fentanyl.

Detailed description: after being informed about the study and potential risks. All patients giving written consent will be randomized by double blind manner into two equal groups (T group and F group). Using computer generated randomization table; each group consists of 51 patients:Group (T) (n=51): Patients will receive preemptive intravenous infusion of tramadol plus paracetamol .

Group (F) (n=51): Patients will receive preemptive intravenous fentanyl.

Eligibility criteria: Inclusion Criteria:

* Patients scheduled for day case surgeries.
* Patient acceptance to be included into the study.
* Both sex.
* Patients with ASA physical status I, II.
* BMI 25 - 30 kg m-2.
* Duration of surgery from 1-2 hours

Exclusion Criteria:

-Uncooperative patients and patients with psychological problems.-

* Patients with liver or renal impairment.
* Patients with history of allergy to drug used in the study.
* Patients with chronic pain.
* Patient on pain therapy.

Primary outcomes:
measure: Enhanced recovery score
timeFrame: at the end of 24 hour after surgery.
Secondary outcomes:
measure: The duration of PACU stay
timeFrame: 2 days postoperative
measure: Duration of postoperative hospital stay
timeFrame: 2 days postoperative
measure: Postoperative pain severity
timeFrame: recorded upon arrival to recovery room and at 1, 2, 4, 6 and 12hours postoperatively based
measure: postoperative agitation score
timeFrame: immediately after extubation, on arrival to PACU, 10 minutes and 20 minutes after arrival to PACU:
Other outcomes:
Locations:
city: Zagazig
country: Egypt
facility: Aculty of Medicine,Zagazig University
state: El Sharkia
Study officials:
affiliation: Zagazig University
name: marwa M Medhat, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04346472: Longitudinal MRI Assessment in Patients With Diffuse Low-grade Gliomas
Official title: Retrospective Longitudinal Follow-up in Patients With Diffuse Low-grade Glioma With Multimodal MRI Assessment
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Low-grade Glioma
Keywords: Glioma
Magnetic Resonance Imaging
Magnetic Resonance Angiography
Disease Progression
Supratentorial Neoplasms
Blood Volume
Contrast Media
Gadolinium DTPA
Image Processing, Computer-Assisted
Neovascularization, Pathologic
Diffuse low grade glioma
Relative regional cerebral blood volume ( rRCBV)
Early prognosis of anaplasic transformation
Diffuse low grade glioma anaplasic transformation
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2020-04-15
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with diffuse low-grade glioma (WHO grade II)

Brief summary: Retrospective longitudinal follow-up in patients with diffuse low-grade glioma with multimodal MRI assessment


Eligibility criteria: Inclusion criteria:

* Initial WHO grade II
* At least 3 exploitable MRI each including a morphologic FLAIR sequence and perfusion imaging

Exclusion criteria:

-Major protected person ( trusteeship, curatorship, justice safeguard)

Primary outcomes:
measure: Longitudinal variation of the relative regional cerebral blood volume
timeFrame: 1 day
Secondary outcomes:
measure: Collection of histological
timeFrame: 1 day
measure: Collection of radiological
timeFrame: 1 day
measure: Collection of clinical varaibles
timeFrame: 1 day
Other outcomes:
Locations:
city: Montpellier
country: France
facility: Uhmontpellier
Study officials:
affiliation: University Hospital, Montpellier
name: Nicolas MENJOT DE CHAMPFLEUR, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03848572: Repetitive Assessement of PRECISE-DAPT Score
Official title: A Randomized Study of Repetitive Assessement of PRECISE-DAPT Score During Dual Antiplatelet Therapy: The RE-SCORE Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiovascular Diseases
Interventional Cardiology
Keywords: Dual Anti-platelet Therapy
Bleeding
Lead sponsor: University of Roma La Sapienza
Sponsor class: OTHER
First posted: 2019-02-20
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel Assignment
Primary purpose: PREVENTION

Brief summary: Patients treated with percutaneous coronary intervention (PCI) require dual antiplatelet therapy (DAPT). Preliminary assessment of the PRECISE-DAPT score is mandatory in order to assess the risk of bleeding while on DAPT. The score takes into consideration age, creatinine clearance, haemoglobin, white blood- cell count and previous spontaneous bleeding. One should consider, however, that some of the variables included in the PRECISE-DAPT score might change with time. As a consequence, the PRECISE-DAPT score should not be considered a static score as it might vary after the initial computation.

It remains unknown, however, if the use of the delta PRECISE-SCORE, which reflects the change in score between baseline and follow-up, might help to improve the management of PCI patients in order to decrease the bleeding risk during follow-up.

Detailed description: The RE-SCORE trial is a multicenter study aimed at comparing usual care of patients treated with PCI with a novel strategy of change of therapy during follow-up on the base of the Delta PRECISE-DAPT score, as assessed every 3 months in PCI patients receiving DAPT. The primary end-point of the study is the occurrence of bleeding, as defined according to the criteria of the Bleeding Academic Research Consortium (BARC). The second end-point is a composite of cardiac death, myocardial infarction, stroke, definite or probable stent thrombosis (ST), or BARC criteria type 2, 3 or 5 bleeding.

Eligibility criteria: Inclusion Criteria:

* Consecutive patients undergoing percutaneous coronary intervention
* Indication to dual antiplatelet therapy for at least 3 months

Exclusion Criteria:

- Contraindications to dual antiplatelet therapy lasting more than 3 months

Primary outcomes:
measure: Bleeding episode
timeFrame: 12 months
Secondary outcomes:
measure: Ischemic episode
timeFrame: 12 months
Other outcomes:
Locations:
city: Rome
country: Italy
facility: San Raffaele Pisana
city: Rome
country: Italy
facility: Sapienza University
Study officials:
affiliation: Sapienza University
name: Carlo Gaudio, MD
role: STUDY_CHAIR
References:
Clinical trial NCT05255172: Exercise Intervention in Patients With Heart Failure With Preserved and Reduced Ejection Fraction
Official title: Physiological Mechanisms Affecting Exercise Capacity in Patients With Heart Failure - an Exercise Intervention Study Evaluated With Several Modalities
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Heart Failure New York Heart Association (NYHA) Class II
Heart Failure New York Heart Association (NYHA) Class III
Lead sponsor: Region Skane
Sponsor class: OTHER
First posted: 2022-02-24
Enrollment: 120
Sex: ALL
Minimum age (years): 50
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The objective of this study is to assess by what physiological mechanisms patients with heart failure benefit from exercise. Effects of an exercise intervention will be assessed for both central (heart and lungs) and peripheral (muscle fiber and mitochondria) factors.

Detailed description: A randomized, non-blinded prospective intervention trial. Patients randomized to exercise intervention will undergo supervised aerobic training on ergometer cycle for 12 weeks whilst control group receives standard care. Before and after the intervention, all participants will undergo cardiac magnetic resonance imaging (cardiac MR) examinations, Ventilation/Perfusion Single Photon Emission Computed Tomography (V/P SPECT), Cardiopulmonary exercise tests, muscle biopsies and blood sampling.

Eligibility criteria: Inclusion Criteria:

1. Signs and symptoms of heart failure
2. Age ≥50 years
3. Stable chronic heart failure (no hospitalizations within past month, no new medications past month)
4. Able to understand and follow exercise prescription
5. Currently physically inactive (less than 150 minutes/week moderate intensity exercise)

Exclusion criteria:

1. Currently or within the past 6 months been involved in cardiac rehab with exercise
2. Devices or implants not compatible with magnetic resonance imaging or exercise testing
3. Any orthopedic or medical condition affecting participation in testing and training
4. Signs of acute ischemia during baseline cardiopulmonary exercise testing
5. Participation in other clinical trials that may affect results
6. Moderate or severe valvular disease
7. Atrial fibrillation
8. Moderate or severe chronic obstructive pulmonary disease
9. NYHA class IV

Primary outcomes:
measure: Maximal oxygen uptake (VO2peak)
timeFrame: 12 weeks intervention
Secondary outcomes:
measure: Health related quality of life
timeFrame: 12 weeks intervention
measure: Cardiac volumes and function
timeFrame: 12 weeks intervention
measure: Perfusion gradients on Ventilation / Perfusion Single Photon Emission Computed Tomography (V/P SPECT)
timeFrame: 12 weeks intervention
measure: Mitochondrial function
timeFrame: 12 weeks intervention
Other outcomes:
Locations:
city: Lund
country: Sweden
facility: Skåne University Hospital Lund
Study officials:
References:
Clinical trial NCT00118872: Beneficial Bacteria to Prevent Malnutrition and Diarrhea in Pakistani Infants
Official title: Feasibility Study of Probiotics for Growth Faltering in Pakistan
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Malnutrition
Diarrhea
Keywords: Growth and Development
Pakistan
Weaning
Probiotics
Infant
Lactobacillus GG
Lead sponsor: Tufts University
Sponsor class: OTHER
Collaborators: name: National Center for Complementary and Integrative Health (NCCIH)
First posted: 2005-07-12
Enrollment: 120
Sex: ALL
Minimum age (years): 1
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study will determine whether lactobacillus GG (LGG), a beneficial bacterium, when given in yogurt, will reduce growth faltering in babies living in a poor area of Pakistan who are being weaned from breastfeeding.

Study hypothesis: Use of the probiotic bacteria LGG at the time of weaning will lessen the impact of faltering growth in babies living in the slums of Pakistan.

Detailed description: Faltering growth due to malnutrition and recurrent diarrhea is a serious public health concern in developing nations, particularly among infants who are being weaned from breastfeeding. Evidence suggests that the use of the probiotic bacterium LGG reduces the risk of diarrhea, shortens episodes of diarrhea, and enhances the immune system. Babies who are being weaned from breastfeeding will be given LGG-containing yogurt in this study to determine whether LGG will reduce faltering growth caused by diarrhea and malnutrition.

Infant participants will be enrolled at or within 5 weeks of birth and followed throughout the weaning period. During the weaning period, participants will be randomly assigned to either receive LGG-containing yogurt or placebo yogurt everyday for 3 months. All participants will have height and weight measurements taken at study entry and at Month 3 (study completion). The number of diarrhea episodes experienced by participants during the study will be assessed at study completion to determine participants' health.

Eligibility criteria: Inclusion Criteria:

* Born and reside in Bilal Colony, Karachi Pakistan during the study
* Parent or guardian willing to provide informed consent
* Parent or guardian willing to permit home visits
* Predominantly breastfed at study start

Exclusion Criteria:

* Malnutrition at time of weaning
* Medical condition that would affect response to LGG

Primary outcomes:
measure: Growth, as measured by weight for age and height
timeFrame: 3 months
Secondary outcomes:
measure: Number of episodes of diarrhea
timeFrame: 3 months
measure: duration of episodes of diarrhea
timeFrame: 3 months
Other outcomes:
Locations:
city: Karachi
country: Pakistan
facility: Aga Khan Medical Center
Study officials:
affiliation: Tufts University
name: Christine A. Wanke, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06787872: Prevalence of Lichen Planus
Official title: PREVALENCE of LICHEN PLANUS AMONG PATIENTS REFERRED to the DEPARTMENT of ORAL DISEASES and PERIODONTOLOGY, LJUBLJANA, SLOVENIA in the PERIOD 2021-2023
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Oral Lichen Planus
Lead sponsor: University of Ljubljana
Sponsor class: OTHER
First posted: 2025-01-22
Enrollment: 111
Sex: ALL
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 111 patients with Oral Lichen Planus referred to the Departement of Oral diseases and Periodontology, Ljubljana, Slovenia during the period 2021-2023 were included in the study.

Brief summary: Clinical records of all patients referred to the Department of Oral diseases and periodontology in the period 2021-2023 were retrogradely assesed. The prevalence of patients with the diagnosis of Oral lichen planus and contributing factors were accordingly analyzed.

Detailed description: Clinical records of 111 patients with the clinical or histopathological diagnosis of Oral ichen planus were included in the study. The prevalence of oral lichen planus was calculated and all the contributing factors including age, gender, location, type, skin involvement, presence of peridontal disease, systemic diseases and medications were assesed.

Eligibility criteria: Inclusion Criteria:

* All patients clinically or histopathologically diagnosed with Oral Lichen Planus

Exclusion Criteria:

* All patients not clinically or histopathologically diagnosed with Oral Lichen Planus

Primary outcomes:
measure: Prevalence of Oral Lichen Planus of referred patients
timeFrame: 2021-2023
Secondary outcomes:
Other outcomes:
Locations:
city: Ljubljana
country: Slovenia
facility: University Medical Centre, Ljubljana, Slovenia
Study officials:
References:
Clinical trial NCT00628472: Novel Technique for Botulinum Toxin Injection to Minimize Patient Discomfort
Official title: Novel Technique for Botulinum Toxin Injection to Minimize Patient Discomfort
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain
Keywords: botulinum toxin a
botox
Decreasing botox injection pain
injections
Lead sponsor: Henry Ford Health System
Sponsor class: OTHER
First posted: 2008-03-05
Enrollment: 21
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: This single blinded randomized pilot study was performed on 21 Caucasian females to determine if injections through follicular openings were less painful than traditional injections for cosmetic botulinum toxin type A injections.

Detailed description: Objective: To investigate whether injection of botulinum toxin type A is less painful if performed through follicular openings versus traditional non-specific approach.

Design: Prospective, randomized, single-blinded study.

Setting: Academic dermatology department.

Patients: A volunteer sample of twenty female patients aged 25-55 who had no prior history of botulinum toxin injection.

Intervention: Each patient received six randomized injections of botulinum toxin type A (Botox® Allergan). Two injections into the procerus muscle and two into each corrugator muscle. Three of the injections were performed through follicular openings and three were performed traditionally.

Main Outcome Measure: Patient discomfort on a 1-10 scale and direct comparison between the two injection techniques.

Eligibility criteria: Inclusion Criteria:

* Female
* No prior history of botulinum toxin
* Age 25-55

Exclusion Criteria:

* Male
* Prior history of botulinum toxin
* Neuromuscular disorders
* Aminoglycoside therapy

Primary outcomes:
measure: Decrease pain on injection for treatment intervention assessed on a 10 point scale
timeFrame: At time of intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Detroit
country: United States
facility: Henry Ford Health System
state: Michigan
Study officials:
affiliation: Henry Ford Health System
name: David M Ozog, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04056572: Study of TQ-B3139 in Subjects With Anaplastic Lymphoma Kinase (ALK) Positive Non-Small Cell Lung Cancer (NSCLC) Previously Treated With Crizotinib
Official title: A Single-arm, Multicenter Study to Evaluate the Efficacy and Safety of TQ-B3139 in Patients With Anaplastic Lymphoma Kinase (ALK) Positive Non-Small Cell Lung Cancer (NSCLC) Previously Treated With Crizotinib.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: ALK-positive NSCLC
Lead sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2019-08-14
Enrollment: 135
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To evaluate the efficacy and safety of TQ-B3139 in subjects with ALK-positive non-small cell lung cancer that have demonstrated progression during or after crizotinib treatment whether or not previously treated with cytotoxic chemotherapy.


Eligibility criteria: Inclusion Criteria:

1. 18 and 75 years.
2. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 1.
3. Life expectancy ≥12 weeks.
4. Histologically or cytologically confirmed diagnosis of advanced or metastatic NSCLC that is ALK-positive.
5. Has progressive disease during or after crizotinib treatment.
6. Has a measurable disease.
7. Adequate organ system function.
8. Understood and signed an informed consent form.

Exclusion Criteria:

1. Diagnosed and/or treated additional malignancy within 5 years prior to randomization.
2. Hypersensitivity to TQ-B3139 capsule.
3. Has received ALK TKIs other than crizotinib.
4. Has received any cancer therapy within 4 weeks or 5 times of t1/2.
5. Has received major surgery within 4 weeks.
6. Has received any radiotherapy or minor surgery within 2 weeks.
7. Acute toxicity ≥ Grade 2 caused by previous cancer therapy.
8. Has active viral, bacterial and fungal infections within 2 weeks.
9. Has serious cardiovascular diseases.
10. Has currently uncontrollable congestive heart failure.
11. Has continuous arrhythmia ≥ Grade 2, any degree of poor controlled atrial fibrillation or QTc interval \> 480ms.
12. Has interstitial fibrosis or interstitial lung disease.
13. Brain metastases with symptom or carcinomatous meningitis.
14. Has active hepatitis B or hepatitis C.
15. Has multiple factors affecting oral medication.
16. Breastfeeding or pregnant women.
17. According to the judgement of the researchers, there are other factors that subjects are not suitable for the study.

Primary outcomes:
measure: Objective Response Rate (ORR)
timeFrame: up to 36 months
Secondary outcomes:
measure: Progression-free survival (PFS)
timeFrame: up to 36 months
measure: Disease control rate (DCR)
timeFrame: up to 36 months
measure: Overall survival (OS)
timeFrame: up to 36 months
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Sun-Yat-Sen University Cancer Center
state: Guangdong
city: Changsha
country: China
facility: Hunan Cancer Hospital
state: Hunan
Study officials:
References:
Clinical trial NCT03212872: Blood Ammonia as Predictor for Esophageal Varices and Risk of Bleeding
Official title: Evaluation of Blood Ammonia Level as a Non Invasive Predictor for Presence of Gastroesophageal Varices and Risk of Bleeding
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Chronic Liver Disease
Esophageal Varices
Keywords: Ammonia
bleeding risk factors
endoscopic risk signs for bleeding
esophageal varices
Lead sponsor: Tanta University
Sponsor class: OTHER
First posted: 2017-07-11
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

Brief summary: Assessment of blood ammonia level as a non-invasive predictor for presence of EV and risk of bleeding

Detailed description: A prospective cross sectional study on 150 consecutive patients screening for esophageal varices.

Patient groups groups:

Group (1): 100 patients with esophageal varices

Group (2): 50 chronic liver disease patients with no esophageal varices as a control group.

All patients will be subjected to:

1. - Detailed history-taking
2. - Full clinical examination
3. - Laboratory investigations:

   * Complete blood picture (CBC)
   * Erythrocyte sedimentation rate (ESR)
   * Renal function tests
   * Liver function tests
   * Prothrombin time and activity
   * Viral markers (HCV Ab - HBV Ag)
   * Blood ammonia level.
4. - Pelviabdominal US: Ultrasound examination of the liver, portal venous system, spleen, kidney and other abdominal organs.
5. - Upper GITendoscopy:

   * Varices will be classified according to the Japanese classification 1996,
   * The Baveno 11 score will be used to differentiate between mild and severe portal hypertensive gastropathy.

Eligibility criteria: Inclusion Criteria:

* patients with chronic liver disease

Exclusion Criteria:

* Patient in hepatic encephalopathy or coma.
* Patient in active bleeding or with history of bleeding within the two weeks prior to entry in the study .
* Patients with heart failure.
* Patients with renal failure.
* Patient with hepatocellular carcinoma and portal vein thrombosis.
* Patient taking Beta blockers.

Primary outcomes:
measure: level of serum ammonia in patients with risk factors for bleeding from esophageal varices
timeFrame: 24 months
Secondary outcomes:
Other outcomes:
Locations:
city: Tanta
country: Egypt
facility: Tanta Faculty of Medicine
state: Gharbiah
Study officials:
affiliation: Tanta University
name: Ferial El-Kalla, MD
role: PRINCIPAL_INVESTIGATOR
References: