louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02782338: The Effect of Voltaren-ophtha 0.1% Eye Drops on INR Levels (International Normalized Ratio) in Patients Taking Warfarin
Official title: The Effect of Voltaren-ophtha 0.1% (Diclofenac Sodium 0.1%) Eye Drops After Cataract Surgery on INR Levels (International Normalized Ratio) in Patients Taking Warfarin
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Blood Coagulation Disorders
Keywords: warfarin
Voltaren eye drops
INR
Lead sponsor: Wolfson Medical Center
Sponsor class: OTHER_GOV
First posted: 2016-05-25
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population will include approximately 100 patients, taking warfarin and that are candidates for cataract surgery. These patients will continue their warfarin therapy as usual and at the same dose, before and after the operation.

Brief summary: A prospective study intended to examine the effect of topical Voltaren-Ophtha 0.1% eye drops after cataract surgery on INR levels (international normalized ratio) in patients taking warfarin.

Detailed description: Objective: To examine the effect of topical Voltaren-Ophtha 0.1% eye drops after cataract surgery on INR levels ( international normalized ratio) in patients taking warfarin.

Methods: A prospective study. The study population will include approximately 100 patients, taking warfarin and that are candidates for cataract surgery. These patients will continue their warfarin therapy as usual and at the same dose, before and after the operation.

INR levels (international normalized ratio) will be checked once a week while taking Voltaren eye drops as is customary after cataract surgery.

Eligibility criteria: Inclusion Criteria:

* people taking warfarin
* candidates for cataract surgery

Exclusion Criteria:

* age \<18 years
* pregnant women

Primary outcomes:
measure: INR levels (international normalized ratio) - change is being assessed
timeFrame: 1 week, 2 weeks, 3 weeks and 4 weeks after taking Voltaren Optha 0.1%
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01995903: Developing a Discrimination Model to Diagnose ALS
Official title: Developing a Discrimination Model to Diagnose ALS Using Advanced MRI Techniques
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Amyotrophic Lateral Sclerosis
Lead sponsor: University of Michigan
Sponsor class: OTHER
First posted: 2013-11-27
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: To combine several brain imaging techniques to develop a new diagnostic test to help with earlier diagnosis of amyotrophic lateral sclerosis.

Detailed description: Early diagnosis and lack of understanding of the pathophysiology of ALS remain a significant obstacle to making a timely intervention to help patients suffering from this fatal disease. We envision a future in which neuroimaging techniques will be a critical tool in the diagnostic work-up of ALS. Advanced neuroimaging techniques offer great potential in identifying central nervous system metabolite and cellular alterations in ALS. We propose an innovative approach to combine complementary advanced MRI techniques to interrogate brain chemistry (MRS), brain microstructure (DTI) and brain function (fcMRI) and develop a clinically relevant discriminatory disease model.

Eligibility criteria: Inclusion Criteria:

1. 18 years of age or older
2. subjects with ALS (amyotrophic lateral sclerosis)
3. healthy subjects -

Exclusion Criteria:

1. Active substance abuse
2. Has co-morbid psychiatric disease
3. Has opportunistic CNS (central nervous system) infection
4. Has a history of head injury
5. Has a contraindication for MRI (e.g. cardiac pacemaker, ferromagnetic or metallic implants)
6. Pregnant

Primary outcomes:
measure: Developing a Discrimination Model to Diagnose ALS
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan Hospital
state: Michigan
Study officials:
affiliation: University of Michigan Hospital
name: Bradley Foerster, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00386503: Bioavailability of the Fixed Combination of Amodiaquine and Artesunate Under Fed & Fasted Conditions
Official title: A Randomized, Open-Label, Cross-Over Study, to Compare the Bioavailability of the Fixed Combination of Amodiaquine and Artesunate (COARSUCAM™) After Single Oral Administration Under Fed and Fasted Conditions in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Malaria
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2006-10-11
Enrollment: 22
Sex: MALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: * Primary Objective: to evaluate the interaction with food after a single oral dose of a fixed combination of amodiaquine (AQ) and artesunate (AS) (COARSUCAM™) in healthy male subjects
* Secondary Objective: to assess the clinical and biological safety and tolerability of Coarsucam™


Eligibility criteria: Inclusion Criteria:

* Healthy Caucasian subjects
* Weight between 50 kg and 90 kg. 18 ≤ Body Mass Index ≤ 28 kg/m2.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Primary outcomes:
measure: Pharmacokinetics/Time course of the plasma concentrations of AS, AQ & their pharmacologically active metabolites dihydroartemisinin (DHA) & desethylamodiaquine (DSA), used to determine:Tmax, Cmax, t1/2, AUC(0-t) & AUC(0-Inf) for AS, DHA & AQ
timeFrame: During all the study conduct
measure: Tmax, Cmax, Truncated AUC(0-10d) for DSA
timeFrame: during the study conduct
Secondary outcomes:
measure: Safety and tolerability/Adverse events, physical examinations, vital signs including heart rate and blood pressure, ECG and laboratory parameters.
timeFrame: From the signature of the informed consent up to the end of the study
Other outcomes:
Locations:
city: Paris
country: France
facility: Sanofi-Aventis
Study officials:
affiliation: Sanofi
name: Valerie Lameyre
role: STUDY_DIRECTOR
References:
Clinical trial NCT02900703: Surveillance of Rotavirus Gastroenteritis
Official title: Epidemiological Surveillance of Rotavirus Gastroenteritis With a Perspective of Vaccination
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Gastroenteritis
Lead sponsor: Centre Hospitalier Universitaire Dijon
Sponsor class: OTHER
First posted: 2016-09-14
Enrollment: 9000
Sex: ALL
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children presenting gastroenteritis

Brief summary: * Epidemiological studies have shown the diversity of resistance genotypes and the evolution of their prevalence in the paediatric population. This large study conducted in a context of very low vaccination coverage will generate more precise data on the natural epidemiological evolution of rotavirus, notably the G9 genotype, which has appeared relatively recently.
* This study will allow us to identify and document rare or unusual strains of human or animal origin. The complete genetic characterization of these strains will also make it possible to study their ability to recombine and to assess the risk of emergence. Among these still rare strains, the investigators are particularly monitoring G12 rotavirus, whose ability to recombine raises the risk of emergence.
* For at least one of the centres taking part in the study, the paediatric population studied will be given strong vaccination coverage. It will be extremely interesting to compare the results obtained in the vaccinated population with non-vaccinated children to assess the impact of this vaccination on the distribution of rotavirus genotypes


Eligibility criteria: Inclusion Criteria:

* Children hospitalized or consulting in one of the participating centres since January 2007 for acute gastroenteritis (AGE). AGE is defined by at least 3 soft or liquid stools or at least 3 bouts of vomiting within 24 hours or one of the following signs - diarrhoea or vomiting accompanied by at least 2 additional symptoms among diarrhoea or vomistin, abdominal pain, fever.

Exclusion Criteria:

* Children older than 5 years.
* Children presenting chronic diarrhoea (\> 2 weeks).
* Children presentant immune deficiency.
* Children presenting nosocomial gastroenteritis. The nosocomial nature will be determined by the onset of acute diarrhoea occuring after 48 hours following admission

Primary outcomes:
measure: number of viral strains of rotavirus
timeFrame: through the completion study an average 10 years
Secondary outcomes:
Other outcomes:
Locations:
city: Dijon
country: France
facility: CHU Dijon Bourgogne
Study officials:
References:
Clinical trial NCT04953403: Evaluation of Physical Activity of Patients Admitted to Addiction Service
Official title: Evaluation of Physical Activity of Patients Admitted to Addiction Service
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Alcoholism
Keywords: Psychoactive substances consumption
Physical activity
Alcohol withdrawal
Dependence level
Drug users
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2021-07-08
Enrollment: 107
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: Any patient entering the addictology service for a reason related to addiction (withdrawal, VMI, etc.) at the CHU de St Eloi between January 01, 2020 and May 31, 2020 aged at least 18 years old

Brief summary: Addiction is a public health issue that affects nearly 30% of French people according to INSEE. For several years now, the investigators have known that sport is a real help in the fight against addictions, with recent medical authorization to prescribe physical activities. A study from August 2016 claims that regular physical activity may offset the harmful effects of alcohol. (1) Based on the answers given by 36,370 Britons between 1994 and 2006, the researchers showed the existence of a link between the practice of 150 minutes of physical activity per week and the decrease in deaths linked to consumption. alcohol. These results, compared to 18 other studies (2), reveal the benefits of physical activity in the management of addictions. But what about current practice and addictions and sports practice in general ?


Eligibility criteria: Inclusion criteria:

- Any patient entering the addictology service for a reason related to addiction (withdrawal, VMI, etc.) at the CHU de St Eloi between January 01, 2020 and May 31, 2020 aged at least 18 years old

Exclusion criteria:

* Patient whose hospitalization is not related to addictology (accommodation, medical examination, etc.)
* Minor patient (age \<18 years)

Primary outcomes:
measure: Assess the relationship between the level of physical activity of patients hospitalized for drug addiction withdrawal
timeFrame: 5 months
measure: Assess the relationship between the level of physical activity of patients hospitalized for dependence on alcohol and tobacco
timeFrame: 5 months
measure: level of physical activity of patients
timeFrame: 5 months
measure: The relationship between the level of physical activity before the onset of dependence
timeFrame: 5 months
Secondary outcomes:
Other outcomes:
Locations:
city: Montpellier
country: France
facility: Uhmontpellier
Study officials:
affiliation: University Hospital, Montpellier
name: Hélène Donnadieu-Rigole, MD PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT04545203: Effects of Slow-Stroke Back Massage on CRF
Official title: Effects of Slow-Stroke Back Massage on Chemotherapy-releated Fatigue in Breast Cancer Patients: An Assessor-blinded, Parallel Group, Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chemotherapy-releated Fatigue
Keywords: Chemotherapy-releated fatigue
Slow-stroke back massage
Nursing
Lead sponsor: Selcuk University
Sponsor class: OTHER
First posted: 2020-09-10
Enrollment: 62
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Chemotherapy-related fatigue (CRF) is common in patients with breast cancer and it can be seen between 27% and 96% depending on the stage of cancer and treatment method. At the same time, CRF is reported as the most important symptom that reduces the functional capacity of patients with breast cancer and impairs their quality of life. For this reason, there is a need for an intervention that could decrease or prevent of CRF in breast cancer patients. In the literature, it is stated in the evidence-based guidelines that massage, which is one of the non-pharmacological methods, can be effective in CRF management.

Detailed description: This an assessor-blinded,parallel group randomized controlled trial aimed that investigating the effect of slow-stroke back massage on CRF in breast cancer patients.This trial was conducted in the chemotherapy outpatient clinic of University Hospital located in Turkey. All patients were women who received Adriamycin-Cyclophosphamide (AC)/ Cyclophosphamide-Adriamycin-5 Fluoro-uracil (CAF) regimens every 21 days.

Eligibility criteria: Inclusion Criteria:

* 18 years and older women,
* Stages II or III breast cancer patients who had received at least 1 cycle of chemotherapy and were scheduled to receive 3 more cycles,
* Receiving one of the adriamycin-cyclophosphamide/cyclophosphamide-adriamycin-5-fluorouracil (AC/CAF) chemotherapy protocols,

Exclusion Criteria:

* With metastasis
* Having open wounds and edema on the upper limbs and back
* Using any complementary and alternative (CAM) treatment method to prevent fatigue during administration

Primary outcomes:
measure: Brief Fatigue Inventory
timeFrame: It was filled before and after the 2nd, 3rd and 4th chemotherapy cycles (each cycle is 21 days). Changes in the Brief Fatigue Inventory scores were recorded before and after each three cycles.
Secondary outcomes:
Other outcomes:
Locations:
city: Izmir
country: Turkey
facility: Izmir Bakircay University Health Sciences Faculty
Study officials:
References:
Clinical trial NCT02651103: Changes in Cerebral Oxygenation Based on Intraoperative Ventilation Strategy
Official title: Changes in Cerebral Oxygenation Based on Intraoperative Ventilation Strategy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Posterior Spinal Fusion
Lead sponsor: Nationwide Children's Hospital
Sponsor class: OTHER
First posted: 2016-01-08
Enrollment: 30
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients undergoing posterior spinal fusion

Brief summary: The proposed research aims to investigate how different ventilation strategies may affect cerebral tissue oxygenation in the pediatric population. It will contribute to the literature exploring the NIRS monitoring device which is becoming increasingly utilized in a variety of anesthetic and critical care settings. It may help to guide clinical practice regarding optimal ventilation strategies, and how ventilation may be altered to correct suboptimal cerebral tissue oxygenation.

This prospective study will include 50 patients undergoing posterior spinal fusion that requires placement of an arterial cannulation. There will be no change in the anesthetic or perioperative care of these patients. Tissue and cerebral oxygenation will be monitored using near infrared spectroscopy (NIRS).


Eligibility criteria: Inclusion Criteria:

* Any patient undergoing spinal surgery

Exclusion Criteria:

* None

Primary outcomes:
measure: Change in Cerebral Oxygenation Values Throughout the Procedure
timeFrame: prior to induction of anesthesia in the awake patient and following four ventilation strategies (average time frame of 15 mins. to 5 hours)
Secondary outcomes:
Other outcomes:
Locations:
city: Columbus
country: United States
facility: Nationwide Children's Hospital
state: Ohio
Study officials:
affiliation: Nationwide Children's Hospital
name: Joseph D Tobias, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03804203: Short Course Radiation Therapy in Palliative Treatment of Esophageal Cancer
Official title: SHort Course Accelerated RadiatiON Therapy (SHARON) in Palliative Treatment of Esophageal Cancer: an Interventional, Randomized, Multicentric Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Esophageal Cancer
Radiotherapy
Palliative Care
Keywords: Short Course Radiotherapy
Symptomatic esophageal lesions
Lead sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna
Sponsor class: OTHER
First posted: 2019-01-15
Enrollment: 98
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: Aim of the study is to assess efficacy of a short course radiation treatment in patients with symptomatic esophageal malignant lesions

Detailed description: Standard treatment for esophageal lesions (3000 cGy in 10 daily fractions of 300 cGy each) is compared with experimental treatment (2000 cGy in 4 fractions of 500 cGy twice a day) to demonstrate non-inferiority of this scheme

Eligibility criteria: Inclusion Criteria:

* symptomatic esophageal malignant lesions (primary solid tumors or metastases from solid tumor);
* age\>18 years;
* ECOG performance status 0-3
* no changes in supportive care in the week before radiotherapy

Exclusion Criteria:

* pregnancy
* previous irradiation of the same region

Primary outcomes:
measure: Efficacy of palliation using the short course scheme compared with the standard scheme: Likert scale
timeFrame: 3 months
Secondary outcomes:
measure: acute toxicity in the two treatment groups
timeFrame: 3 months
measure: late toxicity in the two treatment groups
timeFrame: 12 months
measure: Quality of Life (QoL): EORTC questionnaire C15-PAL
timeFrame: 12 months
Other outcomes:
Locations:
city: Bologna
country: Italy
facility: Radiation Oncology Center, Department of Experimental, Diagnostic and Speciality Medicine- DIMES, University of Bologna, S.Orsola-Malpighi Hospital
state: BO
Study officials:
affiliation: Radiation Oncology Center, Department of Experimental, Diagnostic and Speciality Medicine-DIMES, Unversity of Bologna, S. Orsola-Malpighi Hospital
name: Alessio G Morganti, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06734403: Urinary Calculi After Bladder Augmentation in Children
Official title: Management of Patients Who Had Urolithiasis After Bladder Augmentation in Childhood
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Calculi, Urinary
Neurogenic Bladder Disorder
Spina Bifida
Child, Only
Keywords: Urinary Calculus
Bladder Augmentation
Child
Retrospective Study
Lead sponsor: University Hospital, Clermont-Ferrand
Sponsor class: OTHER
Collaborators: name: Central Hospital, Nancy, France
First posted: 2024-12-16
Enrollment: 34
Sex: ALL
Minimum age (years): 0
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients younger than 18 years old, with urinary calculi, after bladder augmentation.

Brief summary: The goal of this observational study is to analyse the occurence of urinary calculi after bladder augmentation in children:

* location of the calculi (kidney or bladder)
* type of bladder augmentation with higher rate of urinary calculi and why
* Find risk factors of urinary calculi in bladder augmentation (age, sex, other bladder procedures..)

Detailed description: Study the data of patients younger than 18 years old, who underwent a bladder augmentation, complicated by urinary calculi.

Eligibility criteria: Inclusion Criteria:

* Patients younger than 18 years old, with urinary calculi, after bladder augmentation

Exclusion Criteria:

* Patients older than 18 years old, with urinary calculi, after bladder augmentation

Primary outcomes:
measure: Rate of participants with urinary calculi
timeFrame: Through study completion, an average of 2 years
measure: Location of urinary calculi in the participants
timeFrame: Through study completion, an average of 2 years
Secondary outcomes:
measure: Time frame between surgery and occurence of urinary calculi in the participants After bladder augmentation
timeFrame: Through study completion, an average of 2 years
measure: Management of urinary calculi after bladder augmentation in the participants
timeFrame: Through study completion, an average of 2 years
measure: Risk factors of urinary calculi after bladder augmentation in the participants
timeFrame: Through study completion, an average of 2 years
Other outcomes:
Locations:
city: Clermont-Ferrand
country: France
facility: University Hospital, Clermont-Ferrand
state: Auvergne
Study officials:
References:
Clinical trial NCT03074903: Does Skyla Insertion Timing Impact Bleeding?
Official title: Does Skyla Insertion Timing Impact Bleeding?
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Vaginal Bleeding
Keywords: intrauterine device
bleeding
Lead sponsor: Rutgers, The State University of New Jersey
Sponsor class: OTHER
First posted: 2017-03-09
Enrollment: 132
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women presenting for intrauterine device insertion.

Brief summary: Women presenting for contraception will be offered the IUS Skyla and study participation. Daily bleeding will be collected for a total of 90 days and correlated with insertion timing and baseline endometrial thickness.


Eligibility criteria: Inclusion Criteria:

* Women aged 18-45
* Parous or nulliparous
* Desire Skyla for contraception
* Regular menstrual cycles (21-35 days)
* Working mobile phone and willing to accept text messages and report daily bleeding data for 90 days

Exclusion Criteria:

* Vaginal or cesarean delivery in the past 12 weeks
* Abortion in the past 6 weeks
* Uterine anomaly distorting the uterus
* Acute pelvic inflammatory disease
* Uterine bleeding of unknown etiology
* Acute liver disease or tumor
* History of progestin-sensitive cancer
* Abnormal pap smear awaiting diagnostic or therapeutic intervention

Primary outcomes:
measure: Bleeding and spotting as collected by daily texts
timeFrame: 90 days
Secondary outcomes:
Other outcomes:
Locations:
city: Morristown
country: United States
facility: Planned Parenthood
state: New Jersey
city: Newark
country: United States
facility: NJFPC
state: New Jersey
city: Newark
country: United States
facility: SHS
state: New Jersey
Study officials:
affiliation: Rutgers University
name: Noa'a Shimoni, MD MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Shimoni N, Choudhury T, Goldman AR, Frondelli M, Chen PH. Bleeding and spotting with the levonorgestrel 13.5 mg intrauterine system: the impact of insertion timing. Contraception. 2019 Jun;99(6):340-344. doi: 10.1016/j.contraception.2019.02.004. Epub 2019 Mar 1.