louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05344781: Relationship and Sexual Satisfaction of Stoma Patients
Official title: Relationship and Sexual Satisfaction of Stoma Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Satisfaction, Patient
Stoma Ileostomy
Stoma Colostomy
Keywords: Sexual satisfaction
stoma patients
relationship satisfaction
Lead sponsor: Klinikum Konstanz
Sponsor class: OTHER
First posted: 2022-04-25
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with ileostomy or colostomy, regardless of reason

Brief summary: Anonymous questionnaire regarding relationship and sexual satisfaction as well as quality of life of stoma patients.

Detailed description: With an anonymous questionnaire relationship, sexual and life satisfaction of stoma patients are investigated. The questionnaire will be made public by support groups and stoma nurses. Analysis of data and publication of sexual and relationship satisfaction of stoma patients.

Eligibility criteria: Inclusion Criteria:

* Ileostomy or Colostomy

Exclusion Criteria:

* Disease affecting sexual functioning
* Disease affecting daily life

Primary outcomes:
measure: sexual satisfaction
timeFrame: September 2022
measure: relationship satisfaction
timeFrame: September 2022
Secondary outcomes:
measure: satisfaction influences
timeFrame: September 2022
Other outcomes:
Locations:
Study officials:
affiliation: Klinikum Konstanz
name: Silvan Haemmerli
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01956981: Controlled Hypotension During Functional Endoscopic Sinus Surgery
Official title: Comparison Between Magnesium Sulfate and Dexmedetomidine in Controlled Hypotension During Functional Endoscopic Sinus Surgery: A Double-blind, Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hemorrhage
Keywords: controlled hypotension, dexmedetomidine, magnesium sulfate.
Lead sponsor: TC Erciyes University
Sponsor class: OTHER
First posted: 2013-10-08
Enrollment: 60
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: PREVENTION

Brief summary: It is very important to decrease the bleeding during functional endoscopic sinus surgery (FESS) in order to increase the visibility of the surgical site. Our primary goal was to investigate the effects of magnesium sulfate and dexmedetomidine used for controlled hypotension on visibility of surgical site.

Detailed description: Background: It is very important to decrease the bleeding during functional endoscopic sinus surgery (FESS) in order to increase the visibility of the surgical site. Our primary goal was to investigate the effects of magnesium sulfate and dexmedetomidine used for controlled hypotension on visibility of surgical site.

Methods: Sixty patients aged between 18-65 years were enrolled. Patients were divided into two groups. In the magnesium sulfate group (Group M) patients were administered 40 kg-1 magnesium sulfate in 100 ml saline solution in 10 minutes as IV loading dose 10 minutes before the induction and 10-15 mgkg-1hour-1 infusion during the surgery. In the dexmedetomidine group (Group D) patients were administered 1 µgkg-1 dexmedetomidine in 100 ml saline solution as loading dose 10 minutes before the surgery and 0.5-1 µgkg-1hour-1 dexmedetomidine during the surgery. Deliberate hypotension was defined as a mean arterial pressure (MAP) being 60-70 mmHg.

Eligibility criteria: Inclusion Criteria:

18 and 65 years scheduled for functional endoscopic sinus surgery

Exclusion Criteria:

* Patients with kidney, liver, hematological and neuromuscular diseases, diabetic neuropathy, any known allergy history to studied agents.
* weight exceeding the ideal body weight more than 30%,
* Being treated with calcium channel blockers, non-steroidal anti-inflammatory drugs, agents affecting neuromuscular blockage,and agents contraindicated for controlled hypotension

Primary outcomes:
measure: visibility scale of the surgical site
timeFrame: every 5 minutes during surgery up to 60 minutes
Secondary outcomes:
measure: Blood Pressure
timeFrame: up to 24 hours
Other outcomes:
Locations:
Study officials:
affiliation: TC Erciyes University
name: Adnan Bayram, Asst. Prof.
role: STUDY_CHAIR
References:
Clinical trial NCT00002781: Boron Neutron Capture Therapy in Treating Patients With Stage III Melanoma
Official title: PROCEDURES FOR BNCT PHASE-I STUDY OF MELANOMA IN THE EXTREMITIES
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Melanoma (Skin)
Keywords: stage III melanoma
recurrent melanoma
Lead sponsor: National Cancer Institute (NCI)
Sponsor class: NIH
First posted: 2004-09-02
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: RATIONALE: Boron neutron capture therapy may selectively kill tumor cells without harming normal tissue.

PURPOSE: Phase I trial to study the effectiveness of boron neuron capture therapy in treating patients with stage III melanoma.

Detailed description: OBJECTIVES: I. Estimate the maximum tolerated dose of neutron irradiation that can be given in combination with borophenylalanine-fructose complex (BPA-F) in patients with stage III melanoma. II. Evaluate the safety of this regimen. III. Evaluate tumor response to this regimen.

OUTLINE: This is a dose-finding study. Patients receive a test dose of borophenylalanine-fructose complex (BPA-F) for biodistribution studies and undergo punch biopses of tumor and normal tissue to measure B-10 concentration. Later, a treatment dose of BPA-F over 1 hour is followed by neutron irradiation. Groups of 3 patients receive escalated doses of neutron irradiation until the maximum tolerated dose is determined. Patients who complete protocol treatment and continue to meet the eligibility criteria may re-enter the study, provided at least 6 months has elapsed since the completion of prior therapy and the field boundary for the new irradiation site is seperated from the boundary of the previously irradiated site. Patients are followed monthly for 12 months, then every 3-6 months as needed.

PROJECTED ACCRUAL: Approximately 15 patients will be entered.

Eligibility criteria: DISEASE CHARACTERISTICS: Biopsy-proven melanoma that is clinical stage III Estimated clinical tumor depth 1.0-6.0 cm from the epidermis Tumor surface diameter no greater than 10 cm Grossly evident cutaneous or subcutaneous tumor nodules are eligible for irradiation

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 70%-100% Life expectancy: More than 3 months Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified Other: No history of phenylketonuria Negative serum pregnancy test required of fertile women Adequate contraception required of fertile women during and for 6 months after the study

PRIOR CONCURRENT THERAPY: No prior radiotherapy to the target area

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Boston University School of Medicine
state: Massachusetts
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
Study officials:
affiliation: Beth Israel Deaconess Medical Center
name: Paul M. Busse, MD, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT06349681: Describe Relations Between qCON and qNOX Indicies During Propofol-Remifentanil General Anesthesia
Official title: Describe Relationship Between qCON and qNOX of the CONOX Monitor During General Anesthesia Perfromed With Propofol and Remifentanil Target Controlled Infusion (TCI)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Anesthesia Brain Monitoring
Keywords: Anesthesia brain Monitoring
TIVA-TCI
CONOX
Lead sponsor: University of Padova
Sponsor class: OTHER
First posted: 2024-04-05
Enrollment: 14
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Women undergoing brast cancer surgery with general anesthesia with Propofol and Remifentanil TCI will be recruited

Brief summary: CONOX is a neuromonitoring EEG- device for sedation (qCON) and analgesia (qNOX) monitoring during general anesthesia.

It is unknown on how the indicies can differentiate themselves so aim of this study is to determine the relationship bewtween the 2 indicies.

Detailed description: CONOX is a neuromonitoring EEG- device for sedation (qCON) and analgesia (qNOX) monitoring during general anesthesia.

It is unknown on how the indicies can differentiate themselves so aim of this study is to determine the relationship bwtween the 2 indicies, as well as with EMG, Concentration of Propofol (CeP) and Remifentanil (CeR) during Total Intravenous Anesthesia with Target Controlled Infusion (TIVA-TCI).

Eligibility criteria: Inclusion Criteria:

* Undergo general anaesthesia with Targeted Controlled Infusion of Propofol (Eleveld or Schnider model) and Remifentanil (Minto model) and CONOX monitoring

Exclusion Criteria:

* Neurological disease
* Psychiatric disease
* Obesity
* Locoregional anesthesia

Primary outcomes:
measure: Correlation between qCON and qNOX
timeFrame: CONOX values will be recorded from start of anesthesia to the return of responsiveness at the end of surgery
Secondary outcomes:
measure: Correlation between qCON and concentrations of Propofol(CeP)
timeFrame: CONOX and TCI values will be recorded from start of anesthesia to the return of responsiveness at the end of surgery
measure: Correlation between qNOX and concentrations of Remifentanil (CeR)
timeFrame: CONOX and TCI values will be recorded from start of anesthesia to the return of responsiveness at the end of surgery
Other outcomes:
Locations:
city: Treviso
country: Italy
facility: Treviso Regional Hospital
state: TV
Study officials:
References:
Clinical trial NCT02749981: Cefazolin Dosing in Children Undergoing Cardiac Surgery With Cardiopulmonary Bypass
Official title: Cefazolin Dosing in Children Undergoing Cardiac Surgery With Cardiopulmonary Bypass
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiopulmonary Bypass
Lead sponsor: University Hospital, Ghent
Sponsor class: OTHER
First posted: 2016-04-25
Enrollment: 56
Sex: ALL
Minimum age (years): 0
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: children undergoing cardiac surgery with cardiopulmonary bypass

Brief summary: Pharmacokinetics of cefazolin in children undergoing cardiac surgery.


Eligibility criteria: Inclusion Criteria:

* pediatric patients undergoing cardiac surgery with cardiopulmonary bypass
* minimum weight 1.8 kg
* intra-arterial or intravenous access other than the drug infusion line available for blood sampling (arterial line is preferred)

Exclusion Criteria:

* no catheter in place for blood sampling
* absence of parental/patient consent
* known hypersensitivity to cefazolin

Primary outcomes:
measure: Assessment of the time during which the unbound cefazolin concentration is above the MIC of S. aureus (fT>MIC) with the current dosing regimen
timeFrame: 3 years
Secondary outcomes:
measure: Optimalisation of the cefazolin dosing regimen to aim for a target unbound cefazolin concentration above the MIC of S. aureus during surgery
timeFrame: 3 years
Other outcomes:
Locations:
Study officials:
affiliation: Ghent University Hospital, Department of Cardiac Surgery
name: Katrien Francois, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: De Cock PA, Mulla H, Desmet S, De Somer F, McWhinney BC, Ungerer JP, Moerman A, Commeyne S, Vande Walle J, Francois K, Van Hasselt JG, De Paepe P. Population pharmacokinetics of cefazolin before, during and after cardiopulmonary bypass to optimize dosing regimens for children undergoing cardiac surgery. J Antimicrob Chemother. 2017 Mar 1;72(3):791-800. doi: 10.1093/jac/dkw496.
Clinical trial NCT02993081: Capsulotomy YAG Laser
Official title: REFRACTIVE CHANGES AFTER CAPSULOTOMY WITH YAG LASER
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Refractive and Accommodative Disorders
Keywords: YAG laser
Lead sponsor: Instituto de Olhos de Goiania
Sponsor class: OTHER
First posted: 2016-12-15
Enrollment: 67
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Sampling method: NON_PROBABILITY_SAMPLE
Study population: We studied 67 eyes of 66 patients , both men and women by analyzing the medical records of a reference ophthalmologic hospital in Goiás.

Brief summary: Study of refractive changes after capsulotomy with YAG laser in facectomized patients.

Detailed description: A retrospective, quantitative study was carried out by analyzing the medical records of a reference ophthalmologic hospital in Goiás. Data from the pre and post YAG laser refractive index data were collected from 67 eyes of 66 patients analyzed in the period from May to November 2016.

We studied 67 eyes of 66 patients , both men and women , and 32 ( 47,7%) underwent myopia after the capsulotomy procedure with YAG laser and 25 ( 37.3%) hypermetropization and 10 (14.9%) maintained the refraction. The difference in refraction was found by the arithmetic mean of the spherical equivalent for the precapsulotomy procedure of -28.85D and post-capsulotomy of -31.75 D , giving a difference of -2.9 .

It was concluded with this study that the use of posterior capsulotomy with YAG laser post facectomy caused changes in the refraction of the patients studied, presenting myopia with greater frequency in the results. With these data, we observed the need for other future studies with a large number of eyes to prove what happened in this study.

Eligibility criteria: Inclusion Criteria: Complete data information about refraction and the date of the YAG laser -

Exclusion Criteria: Incomplete data

-

Primary outcomes:
measure: Refractive changes after capsulotomy with YAG laser
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06011681: The Rapid Diagnosis of MCI and Depression in Patients Ages 60 and Over
Official title: The Proactive Screening and Diagnosis of Mild Cognitive Impairment and Depression in Patients Ages 60 and Over: An Implementation Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Depression
Mild Cognitive Impairment
Lead sponsor: Miro Health
Sponsor class: OTHER
First posted: 2023-08-25
Enrollment: 960
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population will include healthy, worried well, depressed, and mild cognitively impaired seniors from multiple, disparate U.S. geographic regions.

Brief summary: Mild cognitive impairment (MCI) leading to Alzheimer's disease and related disorders (ADRD) represents a significant health and economic burden of the rapidly expanding senior population. The accurate detection and diagnosis of MCI and its common comorbidity, late-life depression (LLD), is essential for prolonging patient quality of life and developing advancements in research and treatment options. The purpose of the proposed program is to refine Miro Health's A.I. to accurately detect, differentiate and diagnose MCI and LLD.


Eligibility criteria: Inclusion Criteria:

* LLD: Age 60 or over; diagnosis of LLD or symptoms consonant with LLD; PHQ-9 score from 15 to 27
* MCI: Age 60 or over; diagnosis of MCI or self-reported insidious onset and continued worsening of cognitive decline; intact activities of daily living
* HC: Age 60 or over

Exclusion Criteria:

* Age 59 or younger; history of unresolved neurological or psychiatric conditions; current medications known to affect cognition; history of substance abuse; unable to perform activities of daily living; change in employment status due to condition

Primary outcomes:
measure: Measure usability of Miro Health assessments (iOS and Android) for patients
timeFrame: Year 1, Q3 - Year 2, Q2
measure: Measure acceptability of Miro Health assessments (iOS and Android) for patients
timeFrame: Year 1, Q3 - Year 2, Q2
Secondary outcomes:
measure: Measure domain score correlations of pencil-paper tests and Miro Health Mobile Assessment
timeFrame: Year 1, Q1 - Year 2, Q2
Other outcomes:
measure: Measure relevance of algorithms in separating depressed, MCI, and healthy control groups
timeFrame: Year 1, Q1 - Year 2, Q2
Locations:
city: Sacramento
country: United States
facility: Miro Health
state: California
city: Miami
country: United States
facility: Miro Health
state: Florida
Study officials:
affiliation: Miro Health
name: Shenly Glenn, BS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05183581: Feeling Hot 1: Environmental Influences of Overnight Measurement on Skin Temperature of the Erectile Penis
Official title: Feeling Hot 1: Investigating the Influence of Clothing and Blankets on Penile Skin Temperature During Male Sexual Arousal
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Erectile Dysfunction
Keywords: Erectile Dysfunction
RigiScan
Nocturnal erection
Penile temperature
Lead sponsor: St. Antonius Hospital
Sponsor class: OTHER
First posted: 2022-01-10
Enrollment: 10
Sex: MALE
Minimum age (years): 18
Maximum age (years): 29
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The Feeling Hot studies focus on the proof-of-principle of using temperature sensing as a tool to detect nocturnal erections. In the Feeling Hot 1 study the influence of environmental factors of overnight measurements are studied in a controlled setting. Healthy individuals will have visually aroused erections in different circumstances (naked, clothing, blankets) to determine the feasibility of this new measurement method for nocturnal erection detection in the search to modernize erectile dysfunction diagnostics.

Detailed description: Differentiation in nature of erectile dysfunction (ED) is currently made by nocturnal erection detection with the RigiScan. The RigiScan uses outdated software, measurements are user unfriendly and system components are out of stock. In the search of modernizing erectile dysfunctions diagnostics, the question has arisen whether temperature measurements can function as a tool for nocturnal erection detection. With the absence of a pressure component, the patient experience should improve. Literature and mathematical modelling studies have shown that the penile temperature increases significantly during erection. However, it is unclear what the influence of environmental factors such as blankets and clothing is on the increase in penile temperature during erection. The Feeling Hot 1 study explores the effects of these environmental factors in a controlled setting to gain insight into the possibility of using temperature sensing to detect nocturnal erections.

Eligibility criteria: Inclusion Criteria:

* Male
* Aged 18 - 29 years
* Capable of getting visually arousable erections

Exclusion Criteria:

* Test subject unwilling to sign informed consent
* Test subject with erectile dysfunction
* IIEF-5 score below 17
* Medical history consisting of sickle cell anaemia, atherosclerosis and/or diabetes type I/II

Primary outcomes:
measure: Temperature increase
timeFrame: 10 minutes
measure: (De)tumescence duration
timeFrame: 10 minutes
Secondary outcomes:
measure: Difference between sexual and nocturnal erections
timeFrame: 10 hours
Other outcomes:
Locations:
city: Nieuwegein
country: Netherlands
facility: St. Antonius Ziekenhuis
state: Utrecht
Study officials:
affiliation: Urologist, St. Antonius Ziekenhuis
name: Jack Beck, Dr.,MD.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00156481: A Qualitative Study About Smoking Practices
Official title: Smoking Practices Among Parents of Urban Children With Asthma: A Qualitative Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Asthma
Lead sponsor: University of Rochester
Sponsor class: OTHER
Collaborators: name: Halcyon Hill Foundation
name: Rochester City School District
name: The Children's Institute
First posted: 2005-09-12
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Parents of children with asthma in Rochester, NY

Brief summary: This study involves in-depth interviews with parents of urban children with asthma and focus groups with additional parents in order to understand their attitudes and beliefs about smoking.


Eligibility criteria: Inclusion Criteria:

* Child with asthma
* Parents being current smokers, ex-smokers, or non-smokers

Exclusion Criteria:

* Non-English speaking families

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Rochester - Families Homes
state: New York
Study officials:
affiliation: University of Rochester
name: Jill S Halterman, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Halterman JS, Fagnano M, Conn KM, Lynch KA, DelBalso MA, Chin NP. Barriers to reducing ETS in the homes of inner-city children with asthma. J Asthma. 2007 Mar;44(2):83-8. doi: 10.1080/02770900601180545.
Clinical trial NCT05095181: To Study the Effects of Host Genetic Factors on Liver Cirrhosis
Official title: Preventive and Personalized Medicine (2021-2023)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Liver Cirrhosis
Keywords: SNP
Lead sponsor: Asfendiyarov Kazakh National Medical University
Sponsor class: OTHER
First posted: 2021-10-27
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: KAZAKH POPULATION

Brief summary: The purpose of this study is to identify genetic determinants of susceptibility to liver cirrhosis . It will assist in predicting individual risks of disease progression and would help to clarify pathophysiologic mechanisms of liver cirrhosis .


Eligibility criteria: Inclusion Criteria:

* hepatitis B

Exclusion Criteria:

* the casual aget of liver disease is not viral infection, such as alcohol abuse

Primary outcomes:
measure: genotyping for the SNP associated with liver cirrhosis
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Almaty
country: Kazakhstan
facility: National Scientific Center of Surgery named after A.N. Syzganova
Study officials:
affiliation: JSC "National Scientific Center of Surgery named after A.N. Syzganova "
name: Bibigul Saparbekovna, PhD
role: PRINCIPAL_INVESTIGATOR
References: