louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06279052: Adolescent Projections During Transition in Prader-Willi Syndrome
Official title: What Projections Towards the Future During a Period of Transition? A Qualitative Study of Adolescents With Prader-Willi Syndrome
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Prader-Willi Syndrome
Lead sponsor: University Hospital, Toulouse
Sponsor class: OTHER
First posted: 2024-02-26
Enrollment: 20
Sex: ALL
Minimum age (years): 15
Maximum age (years): 20
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: Single-center, cross-sectional qualitative study seeking to collect the experience of adolescence and the transition to adulthood of people affected by Prader-Willi syndrome in a population. To do this, the present will carry out a qualitative study with a reflexive thematic analysis of the data collected through semi-structured interviews using an interview guide.


Eligibility criteria: Inclusion Criteria:

* Patients with genetically confirmed Prader-Willi syndrome
* Patients affiliated or beneficiaries of a social security system
* Patients known and followed by the reference center, presenting sufficient intellectual skills to answer the interview questions

Exclusion Criteria:

* Refusal of family participation (if minor)
* Refusal of participation by the patient or his guardian (if of legal age)

Primary outcomes:
measure: Experience of the disease and aspirations regarding the future
timeFrame: 1 hour
Secondary outcomes:
Other outcomes:
Locations:
city: Toulouse
country: France
facility: CHU de Toulouse
Study officials:
affiliation: University Hospital, Toulouse
name: Grégoire BENVEGNU
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01952652: Naproxen Codeine in Arthroscopic Surgery
Official title: Comparison of Post-operative Analgesic Effects of Naproxen Sodium and Naproxen Sodium-codeine Phosphate Administered Preemptively for Arthroscopic Meniscus Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Arthroscopic Meniscus Surgery
Keywords: Naproxen-codeine
preemptive analgesia
day case surgery
Lead sponsor: Baskent University
Sponsor class: OTHER
First posted: 2013-09-30
Enrollment: 61
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: In this study, the aim is to compare the efficacy of single dose naproxen sodium and combination of naproxen sodium-codeine phosphate on post-operative pain in adult patients undergoing arthroscopic menisectomy.Pre-emptive oral naproxen-codeine may be safely and more advantageous than naproxen alone.

Detailed description: Patients receiving preemptive oral naproxen sodium (Group N) or naproxen sodium-codeine phosphate (Group NC) were assigned in 2 groups.Preoperatively, drugs were given orally by a nurse unaware of the study to both groups within 60 minutes before surgery. Hemodynamic datas, possible side effects, pain and sedation levels of patients were recorded. Patient's pain and sedation levels were statistically assessed.

Eligibility criteria: Inclusion Criteria:

* Patients undergoing arthroscopic meniscectomy were included in the study.

Exclusion Criteria:

* ≤ 18 years of age
* hypersensitivity to non-steroidal anti-inflammatory drugs and codeine,
* history of peptic ulcer, gastritis, upper gastrointestinal bleeding
* coagulation disorder
* serious hepatic and renal impairment
* pregnancy
* long-term NSAID and opioid use

Primary outcomes:
measure: Pain scores as measured by Visual Analogue Scale were significantly lower in Group Naproxen codeine (group NC) at all time points compared to Group Naproxen (group N) in 61 patients who underwent arthroscopic meniscus surgery.
timeFrame: postoperative 18 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Adana
country: Turkey
facility: Baskent University School of Medicine Adana Teaching and Research Hospital
Study officials:
affiliation: Baskent University School of Medicine
name: Anis Aribogan, Prof.,MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT03521752: Influence of an Exercise Program in the Elderly Balance
Official title: Influence of a Specific Exercise Program in the Institutionalized Elderly Balance
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Balance; Distorted
Keywords: BALANCE
INSTITUTIONALIZED ELDERLY PEOPLE
THERAPEUTIC EXERCISE
FUNCTIONAL CAPACITY
Lead sponsor: Cooperativa de Ensino Superior, Politécnico e Universitário
Sponsor class: OTHER
First posted: 2018-05-11
Enrollment: 21
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: This study has the objective to determinate the effectiveness of a specific exercise program on balance and functional capacity of the daily activities of institutionalized elderly.

It was a randomized controlled trial with a total of 21 elderly that were randomly distributed into experimental (n = 11) and control groups (n=10). The experimental group performed a specific program exercises during 4 weeks, while the control group wasn't subjected to any intervention. Evaluations were carried out at the beginning and end of the exercise program, for both groups. After the intervention there were no statistically significant differences between groups in total balance and dynamic balance subscale, except static balance subscale.


Eligibility criteria: Inclusion Criteria:

* Age ≥ 65 years
* institutionalized elderly
* Both genders
* Mini-Mental ≥19 pontos
* Protocol attendance ≥ 90%

Exclusion Criteria:

* Cardiovascular diseases
* Contraindication to physical exercise
* Medication (anxiolytics, antidepressants)
* Vestibular disorders
* Previous physiotherapy of 6 months to the present study
* Neurological and neuromuscular diseases
* Use of gaiters
* Another type of physical exercise during the study

Primary outcomes:
measure: Balance
timeFrame: 4 weeks
Secondary outcomes:
measure: Functional capacity
timeFrame: 4 weeks
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03227952: Sensory Stimulation in Fibromyalgia
Official title: Study of the Effectiveness of Vibrotactile Sensory Stimulation in Fibromyalgia Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fibromyalgia
Lead sponsor: Neurovoxel SLP
Sponsor class: OTHER
First posted: 2017-07-24
Enrollment: 77
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Parallel Assignment
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to investigate the effectiveness of low-intensity and prolonged vibrotactile sensory stimulation on symptom relieve in fibromyalgia patients.

Detailed description: The trial will last up to 8 weeks for each subject and includes:

Three weeks treatment 1 (sham or actual) Two week washout Three weeks treatment 2 (sham or actual) Vibrotactile sensory stimulation will consist on whole-body stimulation with mechanical stimuli of pallesthetic type at high rate, low intensity and long daily duration.

Eligibility criteria: Inclusion Criteria:

* A diagnosis of fibromyalgia according to the American College of Rheumatology (ACR) (Arthritis Rheum, 1990;33:160-172)
* Clinical symptoms are not a consequence of other medical disorder (although the presence of other disorders is not an exclusion criterion)
* Diagnoses established by an expert on fibromyalgia.
* Stable treatment of chronic use.
* Subject demonstrates an understanding of the study and a willingness to participate as evidenced by voluntary written informed consent.

Exclusion Criteria:

* Generalized inflammatory articular or rheumatic disease.
* Heavily exercise for 12 hours prior to fMRI assessment
* Severe, non-stable medical, endocrinological or neurological disorder.
* Psychotic disorder or drug abuse.

Primary outcomes:
measure: 101-point verbal rating scale (VRS)
timeFrame: 3 weeks
Secondary outcomes:
measure: Associated symptom improvement
timeFrame: 3 weeks
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Hospital del Mar
Study officials:
affiliation: Hospital del Mar
name: Jesus Pujol, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Pujol J, Ramos-Lopez D, Blanco-Hinojo L, Pujol G, Ortiz H, Martinez-Vilavella G, Blanch J, Monfort J, Deus J. Testing the effects of gentle vibrotactile stimulation on symptom relief in fibromyalgia. Arthritis Res Ther. 2019 Jun 14;21(1):148. doi: 10.1186/s13075-019-1932-9.
Clinical trial NCT01670552: Evaluation of Two Therapies for the Treatment of Osteoarticular Inflammation in Dyspeptic Patients
Official title: Parallel Study, Double-blind, Randomized, to Compare the Safety of Two Therapies for the Treatment of Osteoarticular Inflammation in Dyspeptic Patients.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Acute and Chronic Inflammation
Dyspepsia
Lead sponsor: EMS
Sponsor class: INDUSTRY
First posted: 2012-08-22
Enrollment: 490
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: The purpose of this study is to evaluate the safety of an association with one anti-inflammatory and one gastroprotective agent compared to the one anti-inflammatory and one gastroprotective agent in patients with acute or chronic osteoarticular inflammation.

Detailed description: * Double-blind,randomized, multicenter
* Experiment duration: 14 days
* 03 visits
* Evaluate the safety of an association with one anti-inflammatory and one gastroprotective compared to association with one anti-inflammatory and one gastroprotective agent in patients with acute or chronic osteoarticular inflammation
* Adverse events evaluation

Eligibility criteria: Inclusion Criteria:

* Adults male or female aged ≥ 18 years old;
* Comply with all the purposes and procedures of the study by signing and dating the Informed Consent.
* Acute or chronic osteo-articular injury in need of of anti-inflammatory for a period of 14 days.

Exclusion Criteria:

* Pregnant women, or women in childbearing age who are not in use effective contraception or intending to become pregnant during the study period
* History of peptic ulcer or gastric surgery;
* Use of Non-steroidal anti-inflammatory (NSAIDs), aspirin, proton pump inhibitor (PPIs), H2 blocker and antacid in the past 7 days;
* Contraindication to the use of NSAIDs or PPIs;
* Renal or hepatic impairment;

Primary outcomes:
measure: Comparison relieve pain in patients with osteoarticular diseases and dyspeptic symptoms, defined as visual analogue scale (VAS) version modified Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC).
timeFrame: 14 days
Secondary outcomes:
measure: Incidence of adverse events and dyspeptic complaints during the study
timeFrame: 14 days
Other outcomes:
Locations:
city: Campinas
country: Brazil
facility: Allegisa
state: São Paulo
Study officials:
affiliation: Allergisa Pesquisa Dermato-Cosmetica LTDA
name: Pedro A. Petersen, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Scheinberg M, Pott Junior H, Macedo EA, Bocchi de Oliveira MF, Ecclissato C, Amazonas RB. Efficacy and safety of a fixed-dose combination of nimesulide/pantoprazole compared to naproxen/esomeprazole for pain relief in patients with osteoarticular diseases and dyspeptic symptoms. Drug Des Devel Ther. 2018 Sep 6;12:2775-2783. doi: 10.2147/DDDT.S172068. eCollection 2018.
Clinical trial NCT00414752: Effects of AFQ056 and Nicotine in Reducing Cigarette Smoking
Official title: A Randomized, Double Blind, Multiple Dose, Cross-Over, Placebo- and Active-Controlled Proof of Concept Study to Explore the Effects of AFQ056 and Nicotine (Active Comparator) on Craving and Withdrawal During Voluntary Smoking Abstinence in Healthy Smokers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Smoking Abstinence
Keywords: Smoking, abstinence, craving, smoker, AFQ056, nicotine, placebo
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2006-12-22
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to assess the safety and efficacy of AFQ056 and nicotine compared to placebo on craving and withdrawal symptoms during voluntary smoking stoppage in healthy smokers. This study will also assess how the body interacts with AFQ056.


Eligibility criteria: Inclusion Criteria:

* Healthy, male \& female subjects at least 18 years and ≤60 years of age
* In good health
* Female subjects must be surgically sterilized or postmenopausal.
* Current smokers not intending to quit
* Smoke on average 15 cigarettes or more and less than 60 cigarettes a day for the past year
* Fagerström Test for Nicotine Dependence score of at least 5 (indicates moderate to heavy smokers)
* Willing to refrain from smoking as required
* Written informed consent before entering the study

Exclusion Criteria:

* History of heart disease, septum defect and/or cardiac valves surgery; clinical relevant abnormality in the ECG
* Investigational drug treatment within 4 weeks prior to screening unless local health authority guidelines mandate a longer period
* Women of childbearing potential, pregnant or lactating females
* Donation of one unit (400mL) or more of blood, significant blood loss equaling at least one unit of blood within the past 2 months or a blood transfusion within 8 weeks prior to screening.
* Coffee consumption of more than 6 cups coffee/day
* Use of a medication within 2 weeks prior to Day 1 of each treatment period

Other protocol-defined inclusion/exclusion criteria may apply

Primary outcomes:
measure: Reduction of craving by self-report questionnaires during 3 days of voluntary smoking stoppage
Secondary outcomes:
measure: Reduction in symptoms of withdrawal during 3 days of voluntary smoking stoppage
measure: Reduction in nicotine consumption during 6 days of free smoking
measure: Reduction in impulsivity during 3 days of free smoking and during 3 days of voluntary smoking stoppage
measure: Reduction in craving during 6 days of free smoking
measure: Safety and tolerability of AFQ056 during treatment periods
measure: Assessment of how the body interacts with AFQ056
Other outcomes:
Locations:
city: Nuernberg
country: Germany
facility: Novartis Investigative Site
Study officials:
affiliation: Investigator site
name: Novartis
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06258252: Effect of Metabolic Dysfunction in Branched-chain Amino Acids on Cardiac Function in Patients With Sepsis
Official title: Effect of Metabolic Dysfunction in Branched-chain Amino Acids on Cardiac Function in Patients With Sepsis: an Observational Study
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Sepsis
Lead sponsor: West China Hospital
Sponsor class: OTHER
First posted: 2024-02-14
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with sepsis

Brief summary: The current project was designed to examine the effects of BCAA metabolic dysfunction on cardiac function in septic patients.

Detailed description: Patients with sepsis and with/without type 2 diabetes will be included. Patients prospectively collected the following indicators in the intensive care unit: 1. myocardial injury-related biomarkers: troponin T and B natriuretic peptide levels; 2. cardiac structure-related indicators: the size of the left and right ventricle, left ventricular ejection fraction, etc.3. septic cardiomyopathy incidence: Troponin T\>0.01ng/ml is the standard for the diagnosis of septic cardiomyopathy. Additionally, the investigators will collect the peripheral blood at preoperative, day 1, day 3, and day 5 after surgery. Peripheral blood plasma and PBMCs were separated by differential centrifugation: the concentration of BCAAs in serum and PBMCs; the expression of PBMCs BCAAs metabolic enzymes BCAT 1, BCKDH, and PP 2 Cm by WB; and the levels of AST, ALT, LDH, CK, and CK-MB

Eligibility criteria: Inclusion Criteria:

- patients diagnosed with sepsis with or without type 2 diabetes

Exclusion Criteria:

- patients with immunodeficient diseases patients who accept glucocorticoid or immunosuppressant patients with an age younger than 18 years patients who cannot provide informed consent

Primary outcomes:
measure: The incidence of Sepsis induced cardiomyopathy
timeFrame: up to 7 days post-ICU admission, or at hospital discharge, whichever comes first
Secondary outcomes:
measure: Plasma levels of TroponinT
timeFrame: up to 7 days post-ICU admission, or at hospital discharge, whichever comes first
measure: Plasma levels of type B natriuretic peptide
timeFrame: up to 7 days post-ICU admission, or at hospital discharge, whichever comes first
measure: ejection fraction
timeFrame: up to 7 days post-ICU admission, or at hospital discharge, whichever comes first
measure: Left ventricular and right ventricular size
timeFrame: up to 7 days post-ICU admission, or at hospital discharge, whichever comes first
Other outcomes:
Locations:
Study officials:
affiliation: West China Hospital
name: Fengmin Luo, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01739452: Spanish Registry of Erythropoietic Stimulating Agents Study
Official title: National Registry of Patients Diagnosed With Low-risk Myelodysplastic Syndromes According to the Criteria of the WHO / French-American-British Classification System (FAB) and IPSS and Treated With Erythropoietic Agents.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Myelodysplastic Syndrome
Keywords: Low-risk MDS
myelodysplastic syndrome
retrospective
Lead sponsor: Grupo Español de Síndromes Mielodisplásicos
Sponsor class: OTHER
First posted: 2012-12-03
Enrollment: 722
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients diagnosed with MDS according to WHO classifications or FAB low-risk (IPSS low and intermediate-1) with anemia (Hb ≤ 11 g / dL) and treatment (support / ESA) started before December 31, 2011.

Brief summary: Reviewing Spanish record of myelodysplastic syndromes (RESMD) data base in the group of patients with MDS. The information will be collected retrospectively from diagnosis of MDS, until the date of December 31, 2011.

Detailed description: Review of RESMD data base in the group of patients with MDS from diagnosis of low risk myelodysplastic syndrome (MDS) and occurrence of anemia that began treatment with erythropoiesis stimulating agent (ESAs) / support transfusional before December 31, 2011. In all cases, data obtained will be prior to the date of the start of the study to ensure its retrospective nature, thus reflecting the routine use of erythropoietic agents in clinical and non-interference in the doctor's clinical practice.

Eligibility criteria: Inclusion Criteria:

* The patient has given consent to the collection of data in the RESMD.
* Age ≥ 18 years.
* Patient must be diagnosed with MDS according to WHO classifications or FAB low-risk (IPSS low and intermediate-1) with anemia (Hb ≤ 11 g / dL).
* The patient has studies at the time of diagnosis discard the possibility that MDS anemia is due to deficiency of factors (iron, vitamin B12 or folic acid).
* Initiation of treatment with ESAs or support transfusional at any spanish hematology service before December 31, 2011.

Exclusion Criteria:

* Pretreatment of SMD with hypomethylating agents, lenalidomide, chemotherapy, other.

Primary outcomes:
measure: Collect and evaluate the Spanish experience of anemia treatment.
timeFrame: 6 months
Secondary outcomes:
measure: Duration of response
timeFrame: 6 months
measure: Overall survival.
timeFrame: 6 months
measure: Adverse events
timeFrame: 6 months
Other outcomes:
Locations:
Study officials:
affiliation: University of Salamanca
name: Maria Consuelo Cañizo, MD
role: STUDY_CHAIR
affiliation: University of Salamanca
name: María Díez, MD
role: STUDY_CHAIR
References:
Clinical trial NCT05714852: Promotion of Healthy Eating Behaviors in Type 2 Diabetes Patients
Official title: Promotion of Healthy Eating Behaviors in Type 2 Diabetes Patients
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Healthy Lifestyle
Diabetes
Lead sponsor: University of Valencia
Sponsor class: OTHER
First posted: 2023-02-06
Enrollment: 80
Sex: ALL
Minimum age (years): 50
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Intervention designed to promote healthy eating in patients with type 2 diabetes.


Eligibility criteria: Inclusion Criteria:

* Age
* Type 2 diabetes
* Poor dietary habits

Exclusion Criteria:

* Micro and macro-vascular complications
* Poor glycemic control
* Food allergy

Primary outcomes:
measure: Change in plasma triglycerides
timeFrame: Before - 16 weeks
measure: Change in blood glucose
timeFrame: Before - 16 weeks
Secondary outcomes:
measure: Change in waist circumference
timeFrame: Before - 16 weeks
Other outcomes:
Locations:
city: Valencia
country: Spain
facility: University hospital valencia
Study officials:
References:
Clinical trial NCT03833752: Flexible V/S Rigid Cystoscopy In Men With Urinary Tract Infection
Official title: Randomized Controlled Study To Evaluate The Outcomes Between Rigid And Flexible Cystoscopy In Men With Lower Urinary Tract Symptoms Undergoing Diagnostic Cystoscopy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lower Urinary Tract Symptoms
Keywords: rigid cystoscopy
flexible cystosocpy
UTI
BPH
Lead sponsor: Maulana Azad Medical College
Sponsor class: OTHER
First posted: 2019-02-07
Enrollment: 60
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: The objective of this study is to perform a randomized study, comparing the outcomes of the above two types of cystoscopy in terms of discomfort experienced by the patient, while undergoing the procedure.

Detailed description: Cystoscopy is a commonly performed routine outpatient procedure and an essential diagnostic tool in urology.Compared with flexible endoscopes, rigid instruments offer better image quality, a wider lumen of the working channel, improved irrigant flow and superior handiness. However, flexible cystoscopes provide more options for patient positioning, enable smooth passage over an elevated bladder neck or median lobe, facilitate full inspection of the bladder because of their movable tip and, what is most important is it significantly improve patient comfort(patient can be positioned in any comfortable position).

Eligibility criteria: Inclusion Criteria:

* patients with lower urinary tract symptoms

Exclusion Criteria:

* patients with Suprapubic catheter
* History of radical prostatectomy or cystoprostatectomy
* Clinical evidence of urethral stricture, prostatitis
* Patients with bacterial growth on urine culture

Primary outcomes:
measure: Post Procedure Discomfort
timeFrame: periprocedure
measure: Duration of Procedure
timeFrame: periprocedure
Secondary outcomes:
Other outcomes:
Locations:
city: New Delhi
country: India
facility: Maulana Aazad Medical College
Study officials:
affiliation: Professor, Department of Surgery
name: PAWAN LAL, MS,DNB,DA
role: STUDY_DIRECTOR
References: