louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06964555: Effect of Intravenous Low-Dose Ketamine Infusion With Intravenous Lignocaine Infusion on Post-Operative Pain in Patients Undergoing Laparoscopic Choleysystectomy Under General Anesthesia
Official title: Effect of Intravenous Low-Dose Ketamine Infusion With Intravenous Lignocaine Infusion on Post-Operative Pain in Patients Undergoing Laparoscopic Choleysystectomy Under General Anesthesia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Cholelithiases
Keywords: Cholelithiases
Cholecystectomy
Laparoscopy
Lead sponsor: Fazaia Ruth Pfau Medical College
Sponsor class: OTHER
First posted: 2025-05-09
Enrollment: 100
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: Objective: To determine the effect of low-dose ketamine versus lignocaine on post-operative pain in patients undergoing LC under general anesthesia in a tertiary care hospital.

Sample Selection: Patients of both the gender of age at least 18 years, planned for elective LC with ASA grade I-II were included. Patients with obesity, history of alcohol consumptions, drug abusers, uncontrolled hypertension and diabetics, with chronic pain, allergic to study drugs, having neurological disorders, unable to understand pain scoring system and converted to open LC were excluded.


Eligibility criteria: Inclusion Criteria:

* Patients of both the gender of age at least 18 years
* Patients planned for elective LC
* Patients with ASA grade I-II were included.

Exclusion Criteria:

* Patients with obesity,
* Patients with history of alcohol consumptions, uncontrolled hypertension and diabetics,
* Drug abusers
* Patients with chronic pain
* Patients allergic to study drugs
* Patients having neurological disorders or unable to understand pain scoring system
* Patients converted to open LC

Primary outcomes:
measure: Post operative Pain
timeFrame: 24 hours
Secondary outcomes:
measure: Time to rescue analgesia
timeFrame: 24 hours
measure: Wound Closure
timeFrame: End of Surgery
Other outcomes:
Locations:
city: Karachi
country: Pakistan
facility: Fazaia Ruth Pfau Medical College
state: Sindh
Study officials:
References:
Clinical trial NCT05153655: Ischemic Post-conditioning in Acute Ischemic Stroke Thrombectomy
Official title: Safety and Tolerability of Local Ischemic Post-conditioning in Patients With Acute Ischemic Stroke After Mechanical Thrombectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute Ischemic Stroke
Keywords: acute ischemic stroke
ischemic postconditioning
endovascular thrombectomy
Lead sponsor: Capital Medical University
Sponsor class: OTHER
First posted: 2021-12-10
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Ischemic post-conditioning is a neuroprotective strategy that has been proven to attenuate reperfusion injury in animal models of stroke. The purpose of this proof-of-concept study is to determine the safety and tolerability of ischemic post-conditioning in patients with acute ischemic stroke who are treated with mechanical thrombectomy.


Eligibility criteria: Inclusion Criteria:

* Age 18-80 years;
* Acute ischemic stroke caused by middle cerebral artery M1 segment occlusion;
* Successful recanalization (mTICI 2b/3) after endovascular thrombectomy that confirmed by digital subtraction angiography;
* Written informed consent provided by the patients or their legal relatives.

Exclusion Criteria:

* Known diagnosis or clinical suspicion of cerebral vasculitis or fibromuscular dysplasia;
* Difficulty in reaching the designated position of the balloon used for ischemic post-conditioning;
* Stenting in the middle cerebral artery as rescue therapy during the thrombectomy procedures;
* \> 2 times of balloon dilations as rescue therapy due to angioplasty during the thrombectomy procedures;
* Moderate or severe residual stenosis (≥ 50%) of the culprit artery after recanalization;
* Difficulty in complying with ischemic post-conditioning or other conditions that the investigator considered inappropriate for inclusion.

Primary outcomes:
measure: Number of participants with major response
timeFrame: Immediately after intervention on the day of ischemic post-conditioning
Secondary outcomes:
Other outcomes:
Locations:
city: Tianjin
country: China
facility: Tianjin Huanhu Hospital
state: Tianjin
Study officials:
References:
Clinical trial NCT04281914: Reliability and Validity of The Turkish Version of the Functional Assessment of Chronic Illness Therapy - Treatment Satisfaction - General Questionnaire
Official title: Reliability and Validity of The Turkish Version of the Functional Assessment of Chronic Illness Therapy - Treatment Satisfaction - General Questionnaire
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Satisfaction, Patient
Lead sponsor: Hacettepe University
Sponsor class: OTHER
First posted: 2020-02-24
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patients undergoing physiotherapy and rehabilitation

Brief summary: In the evaluation of the services provided in hospitals in recent years, importance has been given to the measurements based on the perception of the patients. Today, the most frequently used criteria for this purpose are quality of life and patient satisfaction. The general opinion of the experts is that the information obtained with these criteria is valid and reliable.The researchers pointed out that patients who are dissatisfied with the health service provided comply with the recommendations of the healthcare personnel less and thus the primary and secondary preventive services are adversely affected.Although treatment satisfaction is a very important factor in terms of patient adherence to treatment, there is no valid and reliable scale in Turkish to evaluate this factor. This study was carried out to investigate the validity and reliability of The Turkish version of the Functional Assessment of Chronic Illness Therapy - Treatment Satisfaction - General Questionnaire in the patients receiving health care.


Eligibility criteria: Inclusion Criteria:

Getting at least 3 sessions of physiotherapy and rehabilitation services, To be at the cooperative level to understand and answer the surveys. Volunteering to participate in the study.

Exclusion Criteria:

Primary outcomes:
measure: European Organisation for Research and Treatment of Cancer Quality-of-life Questionnaire Core 30
timeFrame: 30 July 2020
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01181414: Spanish Atrial Fibrillation And Resynchronization Study
Official title: Phase 4. Study of Cardiac Resynchronization Therapy in Patients With Permanent Atrial Fibrillation.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Chronic Heart Failure
Cardiomyopathy, Dilated
Atrial Fibrillation
Keywords: Permanent Atrial Fibrillation
Resynchronization therapy
Ablation
Lead sponsor: Hospital Clinic of Barcelona
Sponsor class: OTHER
Collaborators: name: University of Navarrra Hospital (Clinica Universitaria)
name: Fundación para la Investigación del Hospital Clínico de Valencia
name: Puerta de Hierro University Hospital
name: Hospital Universitario Ramon y Cajal
name: Hospital Universitario La Fe
name: Hospital Universitario La Paz
name: Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
First posted: 2010-08-13
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of the present study is to compare the response to cardiac resynchronization therapy (CRT) in patients with chronic advanced heart failure and permanent atrial fibrillation (AF) depending on atrio ventricular junction (AVJ) is ablated or not.

Detailed description: Cardiac resynchronization therapy (CRT) improves the functional capacity and the quality of life and reduces the mortality of patients with dilated cardiomyopathy, low ejection fraction and wide QRS.

Only 2% of patients included in CRT randomized trials were in AF.

To obtain a good response to CRT, percentage \>90% of ventricular pacing must be obtained.

Based on observational studies, current guidelines of CRT recommend the atrio ventricular junction (AVJ) ablation in those patients with permanent atrial fibrillation.

Eligibility criteria: Inclusion Criteria:

* Dilated cardiomyopathy (LVEDD \>56 mm)
* wide QRS (\> 120 msec)
* NYHA III-IV
* EF\<35%
* Permanent AF

Primary outcomes:
measure: Left ventricular reverse remodelling in cardiac resynchronization therapy and atrial fibrillation.
timeFrame: 1-year follow-up
Secondary outcomes:
measure: Clinical response to Cardiac resynchronization therapy.
timeFrame: 1-year follow-up
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Hospital Clinic de Barcelona
Study officials:
affiliation: Hospital Clinic, University of Barcelona
name: Jose M Tolosana, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01399814: Restricted Intravenous Fluid Regime Effects on Immunological Indicators of Elderly Patients Operated for Abdominal Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Surgery
Perioperative Care
Immunization
Abdominal Neoplasms
Lead sponsor: Nanjing PLA General Hospital
Sponsor class: OTHER
First posted: 2011-07-22
Enrollment: 179
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to find out whether perioperative fluid restriction influence on postoperative immunological function. And discuss the probable mechanism that fluid restriction regime effect on clinical data.

Detailed description: Perioperative fluid administration is a common therapy in clinical practice, and recent regime has a history about 50 years. Recently, clinicians found that traditional regime had some disadvantages, for example, pulmonary edema, increased cardiac load, increased body weight. And thus, perioperative fluid restriction regimen has been suggested and proved could reduce cardiopulmonary complications and mortality rates after major elective gastrointestinal surgery.

Patients were divided into two groups randomly and underwent restricted fluid regimen or traditional fluid regimen. We determined the complications and immunological function in two groups, and analyzed the relationship between complications and immunological changes. Based on this we decide the probable mechanism that perioperative fluid restriction effects on complications.

Eligibility criteria: Inclusion Criteria:

* All patients(age≧65y) who was admitted for gastrointestinal cancer surgery were considered eligible if they had no life-threatening systemic disease (ASA groups 1\~3)

Exclusion Criteria:

* lactation
* mental disorders
* language problems
* smoking within two weeks
* diabetes mellitus
* renal insufficiency
* disseminated cancer
* secondary cancers
* inflammatory bowel disease, or diseases hindering epidural analgesia

Primary outcomes:
measure: clinical perioperative complications
timeFrame: 30 days after surgery
Secondary outcomes:
measure: death
timeFrame: 30 days after surgery
measure: adverse effects
timeFrame: 30 days after surgery
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06061614: Safety and Efficacy Study of NGGT002 in PKU Adult Subjects
Official title: A Clinical Study for the Safety and Efficacy of IV Infusion of NGGT002 in the Treatment of Phenylketonuria
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: EARLY_PHASE1
Conditions: Phenylketonurias
Keywords: PAH Deficiency
Lead sponsor: The First Affiliated Hospital of Bengbu Medical University
Sponsor class: OTHER
First posted: 2023-09-29
Enrollment: 9
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: single group
Primary purpose: TREATMENT

Brief summary: This investigator initiated trial is an open-label, dose escalation study to evaluate the safety, tolerability and efficacy of NGGT002, an AAV derived investigational gene therapy product expressing human PAH enzyme in adult Phenylketonuria (PKU) subjects with PAH deficiency. All participants will receive a single administration of NGGT002 and will be followed for safety and efficacy for 5 years.

Detailed description: This study will evaluate the safety and efficacy of NGGT002 gene therapy with three dose cohorts in adult subjects with diagnosis of PKU characterized by PAH deficiency with confirmed PAH gene mutations. NGGT002 will be administered through intravenous infusion. Dose escalation will be initiated from the low dose of NGGT002. After evaluating the safety and efficacy data, a decision will be made regarding the cohort expansion or the escalation to the next dose level. The same process will be followed for subsequent dose cohorts.

Eligibility criteria: Inclusion Criteria:

* Voluntarily sign informed consent form;
* Male and female subjects with diagnosis of PKU caused by confirmed PAH mutation as per the "Clinical Practice Guidelines for Phenylketonuria 2020";
* Age ≥ 18 years;
* Phe concentration ≥ 600 μmol/L at screening and ≥ 600 μmol/L at least once within 2 years prior to screening;
* Subjects who are willing and able to maintain their baseline diet throughout the study, regardless of phenylalanine restriction, except at the investigator's request;

Exclusion Criteria:

* Presence of anti-AAV8 neutralizing antibody
* Prior gene therapy
* Positive hepatitis B virus surface antigen, hepatitis C virus antibody, anti-human immunodeficiency virus antibody or treponema pallidum-specific antibody
* Hepatic function abnormal: alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \> 1.5 × ULN; alkaline phosphatase (ALP) \> 1.5 × ULN; total bilirubin (TBil) \> 1.5 × ULN; international normalized ratio (INR) \> 1.3

Primary outcomes:
measure: Incidence and severity of adverse events (AEs) and serious adverse events (SAEs)
timeFrame: Week 52
Secondary outcomes:
measure: plasma Phe levels
timeFrame: W12, W28, W52
Other outcomes:
measure: total protein intake
timeFrame: W12, W28, W52
Locations:
city: Bengbu
country: China
facility: The First Affiliated Hospital of Bengbu Medical College
state: Anhui
Study officials:
References:
Clinical trial NCT01906814: Adjuvant Chemotherapy for High-risk Retinoblastoma After Enucleation
Official title: Three Cycles Versus Six Cycles of Adjuvant Chemotherapy for the Patients With High-risk Retinoblastoma After Enucleation: Prospective Randomized Control Study
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Retinoblastoma
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
Collaborators: name: Fudan University
First posted: 2013-07-24
Enrollment: 179
Sex: ALL
Standard ages: CHILD
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 3 cycles of chemotherapy(CEV) is not inferior to 6 cycles of chemotherapy(CEV) in the treatment of Stage I enucleated retinoblastoma.

Detailed description: This study will be a phase Ⅲ open label interventional case series. Patients with unilateral Stage I enucleated retinoblastoma will be randomized to receive chemotherapy(CEV) of 3 cycles or 6 cycles every 21 days. Patients will be followed for 60 months.

Eligibility criteria: Inclusion Criteria:

* Ability to provide written informed consent and comply with study assessments for the full duration of the study.
* Definite pathology signs of retinoblastoma, Stage I base on International Retinoblastoma Staging System.
* Received enucleation in the study eye.
* Monocular retinoblastoma.

Exclusion Criteria:

* Any previous disease in the study eye.
* Previous participation in any studies of investigational drugs within 1 month preceding Day 0 (excluding vitamins and minerals).
* History of chemical intervention for retinoblastoma in the study eye.

Primary outcomes:
measure: disease-free survival
timeFrame: five years
Secondary outcomes:
measure: overall survival
timeFrame: five years
measure: safety: side effects of chemotherapy in the Treatment of Retinoblastoma
timeFrame: five years
measure: quality of life (PedsQL4.0 scale) in the Treatment of Retinoblastoma
timeFrame: five years
measure: economic burden due to chemotherapy
timeFrame: during chemotherapy (9 weeks for 3-cycle group, and 18 weeks for 6-cycle group)
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Zhongshan Ophthalmic Center, Sun Yat-sen University
state: Guangdong
Study officials:
affiliation: Zhongshan Ophthalmic Center, Sun Yat-sen University
name: Huasheng Yang, Doctor
role: STUDY_CHAIR
References:
Clinical trial NCT04309214: Market Research - Acceptability Study for New MCT Fat Products
Official title: Market Research - Acceptability Study for a Range of New MCT Based Products (Dr Schär - Kanso) Kanso DeliMCT 53% (Cream) Kanso DeliMCT 28% (Tomato or Mushroom) Kanso DeliMCT 21% (Cacaobar)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ketosis
Epilepsy
Fatty Acid Oxidation Disorder
Malabsorption
Ketogenic Diet
Medium Chain Triglycerides
Lead sponsor: Dr. Schär AG / SPA
Sponsor class: INDUSTRY
First posted: 2020-03-16
Enrollment: 12
Sex: ALL
Minimum age (years): 3
Maximum age (years): 20
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: This is a market research, observational study to evaluate the tolerability and acceptability of MCT supplements for young children, young people and adults with intractable epilepsy, GLUT-1 or PDHD from 3 years to adulthood.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of epilepsy requiring a ketogenic or a specialist diet as part of their treatment.
* Subjects new to taking or who are already taking an MCT product and are willing to try each of the 3 study products for 7 days each. 21 days taking product with 2 days between each new product trialled.
* Those patients who have been taking MCT in their diet should do so for a minimum of 4 weeks before commencement of the study.
* Patients aged 3 years of age to adulthood.
* Written informed consent obtained from patient or parental caregiver.

Exclusion Criteria:

* Presence of serious concurrent illness
* Investigator's uncertainty about the willingness or ability of the patient to comply with the protocol requirements
* Participation in any other studies involving investigational or marketed products concomitantly or within two weeks prior to entry into the study
* Any patients having taken antibiotics over the previous 2 weeks leading up to the study
* Patients already on and MCT product who have been taking it in their diet for less than 4 weeks
* Patients less than 3 years of age
* Patients over 20 years.

Primary outcomes:
measure: Gastrointestinal tolerance
timeFrame: 7 days for each product, maximum 25 days
measure: Product compliance
timeFrame: 7 days for each product, maximum 25 days
measure: Product palatability
timeFrame: 7 days for each product, maximum 25 days
measure: Product acceptability
timeFrame: 7 days for each product, maximum 25 days
Secondary outcomes:
Other outcomes:
Locations:
city: Aberdeen
country: United Kingdom
facility: Royal Aberdeen Children's Hospital
state: Grampian
Study officials:
References:
Clinical trial NCT02944214: Compare the Renal Protective Effects of Febuxostat and Benzbromarone in CKD Chinese Patients
Official title: Compare the Renal Protective Effects of Febuxostat and Benzbromarone in Middle-to-late Stages of Chronic Kidney Disease Patients: a Multi-center Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Chronic Kidney Disease
Hyperuricemia
Abnormal Renal Function
Keywords: Hyperuricemia
Renal Function
Chronic kidney disease
Febuxostat
Benzbromarone
Lead sponsor: Shanghai 10th People's Hospital
Sponsor class: OTHER
First posted: 2016-10-25
Enrollment: 800
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
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 febuxostat and benzbromarone could protect renal function in chinese, and which one could be better.

Detailed description: Chronic kidney disease patients with hyperuricemia and glomerular filtration rate (GFR) 20-60 ml/min were treated by febuxostat or benzbromarone. Follow up the changes of serum uric acid, serum creatinine and GFR levels. Compare the effects on renal function of these two drugs.

Eligibility criteria: Inclusion Criteria:

Chronic kidney disease patients with glomerular filtration rate (GFR,20-60ml/min) who match one of the following criteria:

1. Gout
2. serum uric acid \> 480umol/L

Exclusion Criteria:

1. GFR\<20ml/min or GFR \>60ml/min
2. Liver dysfunction (Aspartate transaminase or/and alanine aminotransferase exceed 2 times of normal range)
3. Urinary tract obstruction
4. unstable angina, heart failure (stage III-IV, NYHA), new stroke, need diuretics for long-term treatment
5. Severe lung diseases or cancers
6. Pregnant woman or woman who prepare to be pregnant，nursing mothers
7. unable to sign informed consent form，or disagree with following-up

Primary outcomes:
measure: serum creatinine, estimated glomerular filtration rate (eGFR)
timeFrame: up to 12th months
Secondary outcomes:
measure: urine protein
timeFrame: 6th months, 12th months
measure: adverse drug reaction
timeFrame: 1st month, 2nd months, 3rd months, 6th months, 9th months, 12th months
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Department of Nephrology & Rheumatology, Shanghai Tenth People's Hospital
state: Shanghai
Study officials:
affiliation: Department of Nephrology & Rheumatology, Shanghai Tenth People's Hospital
name: Ai Peng, MD, PhD
role: STUDY_CHAIR
References: