louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05564923: CARG, VES13, G8 Scales in Predicting Drug Toxicity in Patients Receiving Nivolumab
Official title: CARG, VES13, G8 Scales in Predicting Drug Toxicity in Patients Receiving Nivolumab
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Nivolumab Related Toxicity
Lead sponsor: Namik Kemal University
Sponsor class: OTHER
First posted: 2022-10-04
Enrollment: 100
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Advanced stage cancer patients who have been treated with nivolumab

Brief summary: The Geriatric 8 (G8), Vulnerable Elders Survey (VES-13), and Cancer and Aging Research Group (CARG) questionnaires are among the main tests whose purpose is to predict the risk of chemotherapy-induced toxicity (CRT) and allow treatment. Investigators aimed to investigate the effect of using the G8, VES13, and CARG scales in the geriatric age group in cancer patients receiving nivolumab treatment in predicting side effects.

Detailed description: Investigator aimed to examine whether the G8, VES13, and CARG scales can shed light on clinicians in predicting side effects during the use of nivolumab in geriatric cancer patients. In the chemotherapy unit, demographic information, diagnosis date of the disease, previous treatments, comorbidities, and CARG, VES13, and G8 questionnaires will be recorded face-to-face to the patients who meet the study criteria. In addition, routine hemogram and biochemistry tests, which were requested by the patient's follow-up physician before Nivolumab treatment and which will be requested by the patient's own physician during follow-up visits, will be recorded prospectively. Side effects that may occur during nivolumab treatment will be pursued at each visit. CTCA v.6. will be used for grading.

inclusion criteria

1-Advanced cancer patients whose nivolumab treatment was started by the physician followed up (independent of diagnosis) 2-60 years and over, 3-ECOG performance score 0-1 4-Patients who signed the informed consent form

exclusion criteria

1. Under 60 years old
2. Ecog score \>1

Eligibility criteria: Inclusion Criteria:

* Advanced stage cancer patients who have been treated with nivolumab
* be over 60 years old

Exclusion Criteria:

* be under the age of 60

Primary outcomes:
measure: grade 3-4 nivolumab toxicity
timeFrame: one year from first patient enrolled
Secondary outcomes:
Other outcomes:
Locations:
city: Tekirdağ
country: Turkey
facility: Tekirdağ Namık Kemal University
Study officials:
References:
Clinical trial NCT05099523: Intraoperative Different Concentrations Oxygen And Oxidatıve Stress Markers
Official title: The Effects of Intraoperative Oxygen Used at Different Concentrations on Oxidatıve Stress Markers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stress
Hyperoxia
Keywords: oxidative stress markers
general anesthesia
Lead sponsor: Zonguldak Bulent Ecevit University
Sponsor class: OTHER
First posted: 2021-10-29
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The aim of the study was to assess the effect of intraoperative oxygen (O2), which was applied at 30% and 50% concentrations on patients who had undergone septoplasty surgery, on Total Oxidant Status (TOS), Total Antioxidant Status (TAS), and Oxidative Stress Index (OSI).


Eligibility criteria: Inclusion Criteria:

* patients aged between 18-60 years,
* ASA I-II risk class with a minimum operative time of 1.5 hour(s) for whom septoplasty operation under elective conditions

Exclusion Criteria:

* metabolic, endocrine, hepatic, cardiac, or renal diseases,
* malignancies and who used a drug with antioxidant properties such as vitamin E-C
* acetylcysteine in the last 48 hours,
* patients requiring intraoperative 100% O2 inhalation

Primary outcomes:
measure: EFFECTS OF INTRAOPERATIVE OXYGEN USED AT DIFFERENT CONCENTRATIONS ON OXIDATIVE STRESS MARKERS
timeFrame: end of the surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Zonguldak
country: Turkey
facility: Zonguldak Bülent Ecevit University
state: Kozlu
Study officials:
References:
Clinical trial NCT05770323: Association Between Uric Acid and Acute Coronary Syndrome
Official title: The Association Between Serum Uric Acid Level and Acute Coronary Syndrome in_hospital Outcomes
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Acute Coronary Syndrome
Lead sponsor: Sohag University
Sponsor class: OTHER
First posted: 2023-03-15
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All Patient admited to sohag University in CCU with acute coronary syndrome

Brief summary: The aim of the study is to acess the association between admission serum uric acid level and in_hospital outcomes in patients with acute coronary syndromes

Detailed description: Prospective study

1. To acess patients with acute coronary syndrome including one of (typical Chest pain _ECGchanges _elevated cardic enzyme)
2. the complication occur in patients with hyperurecemia and those with normal uric acid

Eligibility criteria: Inclusion Criteria:

all patients with acute coronary syndrome with one of the Following

* Typical Chest pain
* ECG changes
* Elevated cardiac enzyme

Exclusion Criteria:

* patients aged less than 18 years
* patients with gout
* patients with treated with diuretics
* Patient with CKD
* Patient with chronic haemolytic anemia

Primary outcomes:
measure: Association between serum uric acid level and acute coronary syndrome in hospital outcomes
timeFrame: From the day of admission and 30 days post discharge
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Maloberti A, Biolcati M, Ruzzenenti G, Giani V, Leidi F, Monticelli M, Algeri M, Scarpellini S, Nava S, Soriano F, Oreglia J, Sacco A, Morici N, Oliva F, Piani F, Borghi C, Giannattasio C. The Role of Uric Acid in Acute and Chronic Coronary Syndromes. J Clin Med. 2021 Oct 16;10(20):4750. doi: 10.3390/jcm10204750.
Clinical trial NCT05243823: Vaginal Estradiol Tablets (Vagifem®) and Endometrial Cancer Risk in the Treatment of Postmenopausal Vaginal Atrophy
Official title: Vaginal Estradiol Tablets (Vagifem®) and Endometrial Cancer Risk in the Treatment of Postmenopausal Vaginal Atrophy: A Register-based Cohort Study in Postmenopausal Women
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Postmenopausal Vaginal Atrophy
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2022-02-17
Enrollment: 500000
Sex: FEMALE
Minimum age (years): 50
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population includes postmenopausal women split into two separate cohort studies from two countries - Denmark and US. The study population for both the Danish and the US cohort consists of new users of LDVE (split into Vagifem® and other LDVE products) in the study period, and a comparator group consisting of women using no hormone replacement therapy.

Brief summary: The study will include data from a nationwide Danish cohort of postmenopausal women and the United States of America (US) cohort of postmenopausal women. The Danish nationwide cohort will be established through linkage of Danish national patient registries. The US cohort will be established based on data from US claims database, Truven. The aim of this study is to evaluate whether exposure to Vagifem® increases the rate of endometrial cancer in postmenopausal women.


Eligibility criteria: Inclusion Criteria:

1. Female
2. Age 50-75 years at entry

Exclusion Criteria:

1. Endometrial cancer prior to entry
2. Any use of vaginal estrogen products prior to entry
3. Hysterectomy prior to entry

Primary outcomes:
measure: First time occurrence of endometrial cancer (yes/no) during time in cohort from entry (start of treatment) to exit (end of study period, occurrence of any other cancer (except non-melanoma skin cancer), date of emigration or date of death)
timeFrame: From entry (day 0) to exit (upto 19 years)
Secondary outcomes:
Other outcomes:
Locations:
city: Soeborg
country: Denmark
facility: Novo Nordisk Investigational Site
Study officials:
affiliation: Novo Nordisk A/S
name: Clinical Transparency dept. 2834
role: STUDY_DIRECTOR
References:
Clinical trial NCT06011408: Remote Monitoring and Detecting of Tardive Dyskinesia for Improving Patient Outcomes
Official title: Remote Monitoring and Detecting of Tardive Dyskinesia for Improving Patient Outcomes
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Tardive Dyskinesia
Lead sponsor: iRxReminder
Sponsor class: INDUSTRY
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2023-08-25
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Open-label, observational study with two groups taking antipsychotic with or without Tardive Dyskinesia
Primary purpose: SCREENING

Brief summary: The study is being conducted to validate the feasibility of remote assessment of Tardive Dyskinesia.

Detailed description: The study is being conducted to validate the feasibility of remote assessment of Tardive Dyskinesia. Participants will all be taking an antipsychotic medication and half will have a diagnosis of Tardive Dyskinesia and half will not. Participant responses to interview questions and elements of the Abnormal Involuntary Movement Scale will be collected on video. The videos will be rated by trained observers. Machine learning methods will be used to develop an algorithm to detect abnormal movements in individuals with a known Tardive Dyskinesia diagnosis. The trained rater results will be compared to the algorithm to determine the accuracy of the algorithm.

Eligibility criteria: Inclusion Criteria:

For the non-TD group:

1. Prescribed and taking an antipsychotic medication for 90-days or longer.
2. Tardive Dyskinesia symptoms if present are not from Parkinsons, Tourette's syndrome, Huntington disease.
3. Signed an informed consent.
4. Speaks English fluently.

Exclusion Criteria:

1. Suffered a moderate or severe head injury in the last year;
2. History of a learning disorder or developmental disability that would inhibit a patient from completing the TD protocol.
3. Severe visual impairment that is cannot be corrected by glasses or contacts.

Primary outcomes:
measure: AIMS Score
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Brooklyn
country: United States
facility: Fermata Helath
state: New York
city: Garfield Heights
country: United States
facility: Charak Research Center
state: Ohio
Study officials:
affiliation: Charak Research Center
name: Rakesh Ranjan, M.D.
role: STUDY_DIRECTOR
affiliation: Fermata Health
name: Owen Muir, M.D.
role: STUDY_DIRECTOR
References:
Clinical trial NCT06379308: Anterior Cruciate Ligament (ACL) Revision Surgery: French National Study
Official title: Anterior Cruciate Ligament (ACL) Revision Surgery: French National Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Anterior Cruciate Ligament Rupture
Keywords: Knee
ACL
revision
surgery
Lead sponsor: Centre Hospitalier Universitaire de Saint Etienne
Sponsor class: OTHER
First posted: 2024-04-23
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient with an anterior cruciate ligament (ACL) revision will be included.

Brief summary: This is a national multicentric study led by the French Arthroscopy Society (SFA) evaluating clinical practice in anterior cruciate ligament (ACL) revision surgery (epidemiological data, morphological data, operative data, clinical and functional outcomes, and surgical complication rates).


Eligibility criteria: Inclusion Criteria:

* Patient with an anterior cruciate ligament (ACL) revision, defined as "all surgical procedures involving replacement of the anterior cruciate ligament (ACL) graft with a new graft".

Exclusion Criteria:

* multil-igament injuries
* any procedure where the ACL was not revised and where any additional graft was inserted
* Patients who had already undergone their first revision anterior cruciate ligament (ACL) procedure

Primary outcomes:
measure: Results of Functional score questionary Anterior Cruciate Ligament Return to Sport and Injury (ACL-RSI)
timeFrame: Months: 0, 6, 12 and 24
measure: Results of Functional score questionary Tegner Activity Scale (TAS)
timeFrame: Months: 0, 6, 12 and 24
measure: Results of Functional score questionary Simple Knee Value (SKV)
timeFrame: Months: 0, 6, 12 and 24
measure: Results of Functional score questionary International Knee Documentation Commitee (IKDC)
timeFrame: Months: 0, 6, 12 and 24
Secondary outcomes:
measure: Surgical complications
timeFrame: From surgery to 2 months
Other outcomes:
Locations:
city: Saint-Étienne
country: France
facility: CHU Saint-Etienne
Study officials:
affiliation: CHU SAINT-ETIENNE
name: Thomas NERI, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03089008: Eccentric Exercise in Treatment of Achilles Tendinopathy
Official title: Eccentric Exercise in Treatment of Achilles Tendinopathy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Achillodynia
Lead sponsor: Copenhagen Trial Unit, Center for Clinical Intervention Research
Sponsor class: OTHER
Collaborators: name: Bispebjerg Hospital
First posted: 2017-03-24
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of the present study is to examine the long-term effect of eccentric exercises compared with stretching exercises on patients with achillodynia.

Detailed description: Patients with achillodynia for at least 3 months are randomly allocated to one of two exercise regimens. Exercise is performed daily for a 3-month period. Symptom severity is evaluated by tendon tenderness, ultrasonography, a questionnaire on pain and other symptoms, and a global assessment of improvement. Follow-up is performed at time points 3, 6, 9, 12 weeks and 1 year.

Eligibility criteria: Inclusion Criteria:

1. Pain in the Achilles tendon area with one of the two following findings. a) Distinct tenderness of Achilles tendon with no pain in the neighboring structures. b) Ultrasonographic changes defined as local thickening of the symptomatic tendon or a globally more than 2mm thicker tendon on the sick side.
2. Diffuse pain in the posterior region of the ankle with local tenderness of the Achilles tendon and ultrasonographic changes (as described above).

Exclusion Criteria:

1. Treatment of achillodynia with stretching or eccentric training for more than 2 weeks within the last 2 years.
2. Other injuries in the lower extremity or the knee, which by the examining doctor was evaluated to influence the evaluation of symptoms or the ability to perform the training program.
3. Acute symptoms with ultrasonographic changes consistent with a partial rupture of the tendon.
4. Age less than 18 years or over 70 years.
5. Previous operation on the tendon or steroid injections.

Primary outcomes:
measure: Manually assessed tenderness at inclusion
timeFrame: At inclusion
measure: Change in manually assessed tenderness after 12 weeks
timeFrame: 12 weeks
measure: Change in manually assessed tenderness after 39 weeks
timeFrame: 39 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Bispebjerg Hospital
Study officials:
name: Per Jessen
role: STUDY_CHAIR
References:
Clinical trial NCT04753008: Respiratory Effects of Dopamine in the Perioperative Care
Official title: Respiratory Effects of Dopamine in the Perioperative Care
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Dopamine
Bronchodilation
Heart
Surgery
Functional Disturbance
Lead sponsor: Szeged University
Sponsor class: OTHER
First posted: 2021-02-12
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Dopamine is frequently used as an inotropic drug to elevate cardiac output. In addition to the beneficial cardiac effect of this drug, the few previous studies addressing its ability to alter the airway tone reported controversial results.

Thus, the investigators aimed at clarifying the potential of dopamine to alter gas exchange outcomes and the airway tone in patients undergoing cardiac surgeries with cardiopulmonary bypass.

Blood gas parameters, airway resistance, tissue damping and tissue elastance will be measured in the patients before the CPB, immediately after CPB, and 5 min after administration of dopamine (3 mcg/kg/min).

The importance of the research is to reveal whether the beneficial mechanical changes after dopamine administrations are associated with improvements in gas exchange outcomes. Clarification of this research question have scientific relevance and may also improves patient outcomes.


Eligibility criteria: Inclusion Criteria:

* Cardial surgery patients undergoing cardiopulmonary bypass procedures

Exclusion Criteria:

* Chronic respiratory diseases, elderly (\>80 years)

Primary outcomes:
measure: Arterial oxygen partial pressure (PaO2)
timeFrame: 5 min after administration of dopamine
measure: Arterial carbon dioxide partial pressure (PaCO2)
timeFrame: 5 min after administration of dopamine
measure: Lung mechanics
timeFrame: 5 min after administration of dopamine
Secondary outcomes:
measure: Capnography
timeFrame: 5 min after administration of dopamine
measure: Intrapulmonary shunt
timeFrame: 5 min after administration of dopamine
Other outcomes:
Locations:
city: Szeged
country: Hungary
facility: Barna Babik
Study officials:
References:
Clinical trial NCT06875908: Reliability and Validity of the Turkish Version of General Sleep Disturbance Scale (GSDS-T) in Multiple Sclerosis
Official title: Reliability and Validity of the Turkish Version of General Sleep Disturbance Scale (GSDS-T) in Multiple Sclerosis
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Multiple Sclerosis
Sleep Disturbance
Keywords: Multiple sclerosis
Sleep disturbances
Lead sponsor: Istanbul Medeniyet University
Sponsor class: OTHER
First posted: 2025-03-13
Enrollment: 126
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with Multiple sclerosis who are aged 18-65 years with EDSS score \> 2 and able to speak and read Turkish.

Brief summary: The GSDS-T was developed by Lee KA to assess difficulty falling asleep, waking up during sleep, sleep quality, and daytime alertnes. The Turkish validity and reliability of the scale have been conducted on stroke patients but not on multiple sclerosis patients. The aim of this study is to investigate the validity and reliability of the Turkish version of general sleep disturbance scale (GSDS-T) in patients with multiple sclerosis

Detailed description: The GSDS-T was developed by Lee KA to assess difficulty falling asleep, waking up during sleep, sleep quality, and daytime alertnes. The Turkish validity and reliability of the scale has been conducted on stroke patients but not on multiple sclerosis patients. The aim of this study is to investigate the validity and reliability of the Turkish version of general sleep disturbance scale (GSDS-T) in patients with multiple sclerosis. GSD has 21 questions. This study will be conducted on patients with multiple sclerosis (MS). 126 participants will be included in the study. In order to evaluate the validity of the GSDS-T, the Pittsburgh Sleep Quality Index (PSQI) which can evaluate sleep quality and has been validated in Turkish, will be used. Scales will be repeated after 15 days to assess test-retest reliability.

Eligibility criteria: Inclusion Criteria:

* Individuals over the age of 18 who have been diagnosed with Multiple Sclerosis for at least two years,
* Those with an EDSS score \>2.
* Those without symptoms of insomnia according to the Diagnostic and Statistical Manual of Mental Disorders-5 (DSM-5) diagnostic criteria
* Individuals whose native language is Turkish and who have the ability to speak and understand.

Exclusion Criteria:

* Those with severe spasticity,
* Those with vision and hearing problems,
* Those with a known mental illness (major depression, schizophrenia, psychosis, etc.),
* Those in an acute relapse phase,
* Those using dietary supplements,
* Those using tranquilizers or immunosuppressants.

Primary outcomes:
measure: Sleep disturbances
timeFrame: baseline
measure: Sleep quality
timeFrame: baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Bağcılar
country: Turkey
facility: Bağcılar Training and Research Hospital
state: İstanbul
Study officials:
References:
Clinical trial NCT06588608: Auricular Vagus Nerve Stimulation (aVNS) in Chronic Spinal Cord Injuries (SCI)
Official title: A Pilot Study of Auricular Vagus Nerve Stimulation on Cardiovascular Biomarkers and Glycemic Homeostasis in Persons With Chronic Spinal Cord Injuries
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Spinal Cord Injuries
Lead sponsor: University of Miami
Sponsor class: OTHER
Collaborators: name: United States Department of Defense
First posted: 2024-09-19
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this research is to test if Auricular Vagal Nerve Stimulation (aVNS) is safe in persons with spinal cord injury (SCI).


Eligibility criteria: Inclusion Criteria:

1. Males and females
2. Chronic (equal or greater to 1 year) motor-complete and incomplete SCI Abbreviated Injury Scale (AIS) of A or B at the C5-T10 levels

Exclusion Criteria:

1. Pregnant or breastfeeding
2. Prisoner
3. Failure to satisfy inclusion criteria
4. Previous bariatric surgery
5. Active implantable devices (such as pacemakers)
6. Skin irritation or damage at the site (ear)

Primary outcomes:
measure: Number of Treatment-related Adverse Events (AEs)
timeFrame: Up to 2 weeks
measure: Number of subjects that complete the study
timeFrame: Up to 2 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Miami
country: United States
facility: University of Miami
state: Florida
Study officials:
affiliation: University of Miami
name: Patrick D Ganzer, PhD
role: PRINCIPAL_INVESTIGATOR
References: