louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05313659: Intramuscular Ketamine Effect on Postnasal Surgery Agitation
Official title: Intramuscular Ketamine Effect on Postnasal Surgery Agitation: a Double Blinded Randomized Controlled Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Agitation, Emergence
Keywords: Agitation
Emergence
Ketamine
Intramuscular
Nasal surgery
Lead sponsor: Jordanian Royal Medical Services
Sponsor class: OTHER
First posted: 2022-04-06
Enrollment: 193
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Emergence agitation (EA) is a common complication after nasal surgery. In this study, we aimed to investigate the effect of intramuscular ketamine on EA following septoplasty and open septorhinoplasty (OSRP) when administered at subanesthetic doses at the end of surgery. Sedation and Agitation scores were recorded using The Richmond agitation-sedation score after extubation.

Detailed description: At the end of surgery and immediately after the inhalational agent was discontinued, 2mL of normal saline containing 0.7 mg/kg racemic ketamine was administered intramuscularly to Group-K, whereas 2 mL of normal saline was administered intramuscularly to Group-S using a 3 ml syringe. The injection site of both groups was at the lateral thigh. For postoperative analgesia, 0.07 mg/kg morphine was also given when turning off the inhalational agent. A nasal pack was used in all of the patients. The patients were ventilated with 100% oxygen at a flow rate of 7 L/min. Once the patients met the extubation criteria, they were extubated.

The EA level of the patients was evaluated immediately after extubation till the patient was handed over to the PACU using Richmond Agitation-Sedation Scale (RASS), Table 1, and the highest score was documented by the main investigators. In this study patients with a RASS score of +2 or more were considered to have EA.

Eligibility criteria: Inclusion Criteria:

1. Age group 18-64 years old
2. ASA I-II
3. BMI 20-29.9
4. Patients accepting the study and consenting
5. Undergoing general anesthesia for scheduled septoplasty or open septorhinoplasty.

Exclusion Criteria:

1. ketamine allergy
2. Morphine allergy
3. History of cardiac, neurological, or psychiatric disease, glaucoma,
4. Patients with a body mass index of less than 20 or more than 30 kg/m2

Primary outcomes:
measure: Development of Agitation
timeFrame: immediately After extubation.
Secondary outcomes:
Other outcomes:
Locations:
city: Amman
country: Jordan
facility: Jordanian Royal Medical Services
Study officials:
affiliation: Jordanian Royal Medical Services
name: Husam A. Almajali, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Jordanian Royal Medical Services
name: Ali M. Abu Dalo, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03955159: Effects of Probiotic Supplementation in Hypertensive Women on Menopause
Official title: Effects of Probiotic Supplementation on Autonomic Nervous System Imbalance and Vascular Changes in Hypertensive Menopausal Women: RANDOMIZED CLINICAL TRIAL
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Systemic Arterial Hypertension
Menopause
Dysbiosis
Autonomic Nervous System Imbalance
Lead sponsor: Instituto de Cardiologia do Rio Grande do Sul
Sponsor class: OTHER
First posted: 2019-05-17
Enrollment: 86
Sex: FEMALE
Minimum age (years): 45
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: In postmenopausal women, cardiovascular risk is increased and the mechanisms involving imbalance of the Autonomic Nervous System should be extensively investigated. Recent data suggest a link with intestinal microbiota dysbiosis and probiotic supplementation could be a useful strategy for treating women with increased cardiovascular risk.

Detailed description: After randomization, subjects will be included in their intervention group for a period of three months with initial and final evaluations.

The study will evaluate the effects and possible benefits of probiotic supplementation on the functioning of the Autonomic Nervous System and vascular changes in hypertension in menopausal women.

The intervention groups will be as follows:

1. - Menopausal women with hypertension + Probiotic supplementation
2. - Menopausal women with hypertension + Placebo supplementation

Eligibility criteria: Inclusion Criteria:

* Hypertensive
* At least 1 year of menopause
* Sedentary

Exclusion Criteria:

* Smoker
* Use of psychiatric medications
* Cardiovascular events
* Recent surgeries
* Diabetic
* Use of beta blockers

Primary outcomes:
measure: Autonomic Nervous System
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Porto Alegre
country: Brazil
facility: Instituto de Cardiologia do Rio Grande do Sul
state: RS
Study officials:
affiliation: Instituto de Cardiologia - Fundação Universitária de Cardiologia
name: Maria Claudia Irigoyen, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT06135870: Role of Senescent Cells in Uterine Fibroid Pathogenesis (SOUL Study)
Official title: Role of Senescent Cells in Uterine Fibroid Pathogenesis
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Fibroid
Leiomyoma
Keywords: Senescent cells
Fibroids
Leiomyomas
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2023-11-18
Enrollment: 150
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women between the age of 18-55 years undergoing elective hysterectomy or myomectomy for uterine fibroids

Brief summary: The investigators are evaluating the role of senescent cells in uterine fibroids.

Detailed description: Uterine fibroids are prevalent tumors of uterus characterized by excessive fibrotic tissues. Using new cutting-edge computational methods, the investigators have found that small groups of senescent cells in fibroids work in concert with immune cells to produce soluble factors in fibroid tissues to create a feed-forward loop leading to fibrosis. This project seeks to unravel key cell-cell communication networks involving senescent and immune cells in fibroids to develop new treatments for uterine fibroids.

Eligibility criteria: Inclusion Criteria:

* Subjects must be women above the age of ≥18 - ≤55 years.
* Women with suspected uterine fibroids.
* Subject must be or have been sexually active or have had a previous vaginal exam that used a speculum.
* Subject must be able to understand, read and speak English or Spanish and subsequently, be able to understand what she is consenting to in terms of procedures and use/disclosure of protected health information.

Exclusion Criteria:

* Unwilling to sign the consent form or complete questionnaire.
* Pregnancy.
* Cancer of the uterus

Primary outcomes:
measure: Develop an atlas to comprehensively quantify the rate of senescent cell (SnC) types in fibroid and myometrium tissue samples
timeFrame: 5 years
Secondary outcomes:
measure: Validate the concentration senescence-associated secretory profile (SASP) in cell cultures of senescent cells in uterine fibroids
timeFrame: 5 years
measure: Rate of inhibition of cellular proliferation and ECM deposition by senolytics and senomorphics in fibroids
timeFrame: 5 years
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins Hospital
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: James Segars, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04183270: Survey on Belgian Patients Suffering From Irregular Heartbeat and Starting Treatment With a Drug to Prevent Blood Clots in Blood Vessels and the Heart. This Study is Also Called BELANCOS.
Official title: BELgian ANtiCOagulation Survey for NVAF Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Atrial Fibrillation
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2019-12-03
Enrollment: 164
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: The source population of this study would be approximately 15 cardiologists (hospital or office-based) and 300 NOAC treatment-naïve patients diagnosed with NVAF who will start treatment with a NOAC for this indication.

Brief summary: In this study researchers want to learn more about the patient's and treating doctor's concerns about possible bleedings during treatment with drugs preventing blood clots in blood vessels and the heart - so called blood thinner. The study also wants to find out more about the patient's knowledge on the importance, risks and benefits of treatment with this drug group.

Patients with irregular heartbeat not caused by valvular heart disease who will start treatment with a blood thinner will be asked by their treating cardiologist to complete a questionnaire related to their knowledge and fear of possible bleedings or stroke (blockage or rupture of a blood vessel to the brain) due to the intake of a blood thinner. The treating doctor will complete a similar questionnaire. The study plans to involve 15 cardiologists and 300 patients in Belgium.


Eligibility criteria: Inclusion criteria:

* Male or female adult patients diagnosed with NVAF.
* NOAC treatment-naive patients who will start a NOAC treatment.

Exclusion criteria:

* Previous stroke or thrombosis
* Previous severe bleeding

Primary outcomes:
measure: Age categories of patients
timeFrame: 1 day
measure: Gender (Female or male) of patients
timeFrame: 1 day
measure: Patients' level of agreement with various statements of using NOACs in general
timeFrame: 1 day
measure: Level of patients fear of having a bleeding on a scale from 0 - 10
timeFrame: 1 day
measure: Level of patients fear of having a stroke or thrombosis on a scale from 0 - 10
timeFrame: 1 day
measure: Age categories of physicians
timeFrame: 1 day
measure: Gender (Female or male) of physicians
timeFrame: 1 day
measure: Physicans' level of agreement with various statement of using NOACs in general
timeFrame: 1 day
measure: Level of patients fear of having a bleeding assessed by physicans on a scale from 0 - 10
timeFrame: 1 day
measure: Level of patients fear of having a stroke or thrombosis assessed by physicians on a scale from 0 - 10
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Multiple Locations
country: Belgium
facility: Many locations
Study officials:
References:
Clinical trial NCT06727370: Cognitive Screening in Lung Cancer Patients
Official title: Cognitive Screening in Lung Cancer Patients
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Lung Disease
NSCLC (Non-small Cell Lung Cancer)
SCLC
Keywords: lung cancer
nsclc
sclc
cognitive
Lead sponsor: European Institute of Oncology
Sponsor class: OTHER
First posted: 2024-12-10
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patients diagnosed with lung cancer (both SCLC and NSCLC)

Brief summary: This study aims to investigate the occurrence of cancer and adjuvant therapy-related cognitive impairment in patients with both NSCLC and SCLC. The primary endpoint measure will be the presence of cognitive impairment during the first year after enrollment through the administration of a comprehensive neuropsychological assessment.


Eligibility criteria: Inclusion Criteria:

* Small-cell and non-small-cell lung cancer (stage I, II, III, IV)
* Age ≥ 18 years
* Patients able to speak and read the local language(s) fluently
* Acceptance and signature of informed consent

Exclusion Criteria:

* Age ≥ 70
* Presence of brain metastases
* Patients with concomitant neurological or psychiatric disorders.
* Patients undergoing brain radiotherapy
* Previous diagnosis of lung cancer

Primary outcomes:
measure: cognitive impairment
timeFrame: From baseline to 12 months
Secondary outcomes:
measure: Risk factors on the cognitive profile of lung cancer patients
timeFrame: From baseline to 12 months
Other outcomes:
Locations:
city: Milano
country: Italy
facility: Istituto Europeo di Oncologia
Study officials:
affiliation: Istituto Europeo di Oncologia
name: Gabriella Pravettoni
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00371670: Safety/Efficacy of Balicatib (AAE581) in Adults With Osteoarthritis of the Knee
Official title: A Phase II, 12-month, Double-blind, Placebo-controlled, Dose-finding, Multicenter Study to Evaluate the Safety, Tolerability, and Disease Modifying Efficacy of Daily Oral AAE581 (10, 25 and 50 mg Tablets) in Patients With Painful Knee Osteoarthritis, Kellgren-Lawrence Grade 3 by X-ray
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Knee Osteoarthritis
Keywords: Knee, osteoarthritis, pain, disease modifying
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2006-09-04
Enrollment: 223
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will test efficacy and safety of AAE581 compared to placebo in limiting cartilage loss in patients with painful knee osteoarthritis which is confirmed by X-ray


Eligibility criteria: Inclusion Criteria:

* At least one knee with osteoarthritis with Kellgren-Lawrence grade 3
* Significant osteoarthritis pain in the knee
* Presence of at least one of the risk factors: obesity (BMI \> 28), osteoarthritis at other sites, knee effusion, family history of total joint replacement

Exclusion Criteria:

* Women with childbearing potential
* Secondary osteoarthritis
* Treatment with intra-articular or systemic steroids
* Inability to undergo MRI acquisition

Other protocol defined inclusion/exclusion criteria may apply.

Primary outcomes:
measure: Change from baseline in knee cartilage volume in the target compartment after 6 months
Secondary outcomes:
measure: Change from baseline in:
measure: - Cartilage volume in the different regions of the knee after 6 and 12 months,
measure: - Cartilage score (Whole Organ MRI Scoring system (WORMS)) in the different regions of the knee after 6 and 12 months,
measure: - Bone marrow edema score (WORMS) in the different regions of the knee after 6 and 12 months,
measure: - Joint space width after 6 and 12 months,
measure: - Markers of bone and cartilage degradation (CTX-I and CTX-II at 3, 6, 9, and 12 months
measure: - Pain (analgesic consumption, Western Ontario and McMaster Universities Osteoarthritis Index, Visual Analogue Scale, criteria of the Outcome Measures in Rheumatology Osteoarthritis-Research Society International at 1, 3, 6, 9, and 12 months
Other outcomes:
Locations:
city: Anniston
country: United States
facility: Pinnacle Research Group
state: Alabama
city: Nuernberg
country: Germany
facility: Novartis
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References:
Clinical trial NCT02311270: Survey on Cardiovascular Events in Patients With Metabolic Disease on Chronic Carnitine Supplementation
Official title: Survey on Cardiovascular Events in Patients With Metabolic Disease on Chronic Carnitine Supplementation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Metabolic Disorders
Lead sponsor: University of South Florida
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
First posted: 2014-12-08
Enrollment: 106
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients enrolled in the NAMDC portion of the RDCRN Contact Registry

Brief summary: The purpose of this study is to learn about the effects of long term carnitine use in patients with metabolic disorders and its potential relationship to cardiovascular events.

Detailed description: This online cross-sectional survey will examine the self-reported long-term carnitine use in patients with metabolic disorders and any potential relationship to cardiovascular events.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of mitochondrial disease or any other metabolic disorder
* Any age group
* NAMDC or RDCRN registry participant

Exclusion Criteria:

* Inability to provide informed consent and complete survey
* Lack of participation in NAMDC or RDCRN registry

Primary outcomes:
measure: Assess how many patients with metabolic disorders are on chronic carnitine supplementation.
timeFrame: Up to one year from study activation.
Secondary outcomes:
measure: Assess how many patients who are on chronic carnitine supplementation have experienced a cardiovascular event.
timeFrame: Up to one year from study activation
Other outcomes:
Locations:
city: Tampa
country: United States
facility: University of South Florida
state: Florida
Study officials:
affiliation: Massachusetts General Hospital
name: Amel Karaa, MD
role: STUDY_CHAIR
References:
Clinical trial NCT01908270: Effects of Yoga on Menopausal Symptoms in Women With Breast Cancer
Official title: Randomized Controlled Trial of Yoga for Menopausal Symptoms in Women With Breast Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Menopause
Breast Cancer
Lead sponsor: Universität Duisburg-Essen
Sponsor class: OTHER
First posted: 2013-07-25
Enrollment: 40
Sex: FEMALE
Minimum age (years): 30
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Women with breast cancer and breast cancer survivors are often bothered by menopausal symptoms to a special degree. Treatment options for those symptoms are currently limited as hormone replacement therapy is often prohibited. Yoga has been shown to reduce menopausal symptoms as well as symptoms associated with breast cancer. Therefore, this study aims to investigate whether a 12-week yoga intervention can reduce menopausal symptoms in women with breast cancer and breast cancer survivors.


Eligibility criteria: Inclusion Criteria:

* Breast cancer (Stage I-III)
* After completion of surgical therapy
* After completion of adjuvant radiotherapy and chemotherapy
* Score of 5 or greater on the Menopausal Rating Scale
* Physical and cognitive capacity to participate in the yoga intervention
* Willingness to participate in 10 or more of the 12 yoga interventions
* signed informed consent

Exclusion Criteria:

* Regular yoga practice in the past 12 months
* Planned surgery in the study period
* Diagnosed and medically treated psychosis
* Hormone replacement therapy

Primary outcomes:
measure: Menopausal symptoms
timeFrame: Week 12
Secondary outcomes:
measure: Health-related quality of life (disease-specific)
timeFrame: Week 12
measure: Fatigue
timeFrame: Week 12
measure: Anxiety
timeFrame: Week 12
measure: Depression
timeFrame: Week 12
measure: Menopausal symptoms
timeFrame: Week 24
measure: Health-related quality of life (disease-specific)
timeFrame: Week 24
measure: Fatigue
timeFrame: Week 24
measure: Anxiety
timeFrame: Week 24
measure: Depression
timeFrame: Week 24
measure: Adverse events
timeFrame: Week 12
measure: Adverse events
timeFrame: Week 24
Other outcomes:
measure: Appraisal of body
timeFrame: Week 12
measure: Appraisal of body
timeFrame: Week 24
measure: Body awareness
timeFrame: Week 12
measure: Body awareness
timeFrame: Week 24
measure: Self-esteem
timeFrame: Week 12
measure: Self-esteem
timeFrame: Week 24
measure: Adherence
timeFrame: Week 12
measure: Adherence
timeFrame: Week 24
Locations:
city: Essen
country: Germany
facility: Department of Internal and Integrative Medicine, Kliniken Essen-Mitte, Faculty of Medicine, University of Duisburg-Essen
Study officials:
affiliation: Department of Internal and Integrative Medicine, Kliniken Essen-Mitte, Faculty of Medicine, University of Duisburg-Essen
name: Holger Cramer, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02525770: Comparative Study of the Wear of Uncemented Acetabular Conventional Polyethylene and X3 in Total Hip Replacement, for Stereo-radiographic Analysis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Total Hip Arthroplasty
Lead sponsor: University Hospital, Caen
Sponsor class: OTHER
First posted: 2015-08-17
Enrollment: 112
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: Total hip arthroplasty (THA) is one of the most effective medical procedures. Except for the few early complications (acute infections and dislocations), the patient made a PTH can be assured of a significant improvement in its function and its short-term quality of life. However, clinical studies and records have shown that the lifetime of these implants was limited. The main cause of failure is the "aseptic loosening" influenced by many factors, foremost of which is due to periprosthetic osteolysis debris. This is a major concern for orthopedic surgeons loosening leads, in most cases, the recovery, the importance of osteolysis is a major cause of difficulties and poorer results.

The main objective of the study is to compare, 2 years after the intervention, the penetration of the femoral head in the polyethylene and X3 in the acetabulum in N2VAC® conventional polyethylene.


Eligibility criteria: Inclusion Criteria:

* Patient (18-70 years) with hip disease necessitating the establishment of a total hip replacement

Exclusion Criteria:

* Patient aged 71 or more
* Pregnant woman or wishing to be for the duration of the study
* Resumption of total hip replacement, or cephalic prosthesis cups
* Primary or secondary malignant neoplasm of the hip
* Protected adult patient

Primary outcomes:
measure: Penetration of the femoral head in the polyethylene measure in millimeters
timeFrame: change over baseline and 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Caen
country: France
facility: Département d'orthopédie traumatologie, CHu de Caen
Study officials:
References: