louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00490438: Measurement of Vaginal Squeeze Pressure in Incontinent Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Urinary Incontinence
Keywords: perineometry
Modified Oxford Score
pelvic muscles evaluation
urinary incontinence
vaginal palpation
Lead sponsor: Hospital de Clinicas de Porto Alegre
Sponsor class: OTHER
First posted: 2007-06-22
Sex: FEMALE
Minimum age (years): 30
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE

Brief summary: The patients will be submited to a vaginal squeeze pressure measurements before and after surgeries for urinary incontinence.

Detailed description: Several techniques had been proposed for pelvic floor muscles assessment, however none of them were able to measure the two main functions of these muscles: rising and force of compression. Vaginal palpation is frequently used in clinical evaluation routine and especially the modified Oxford score, but some articles question the Oxford scale sensitivity and its correlation with objective force contraction measurements.

Methods: 45 patients with urinary incontinence treated at the Uroginecology Ambulatory Service of the Hospital de Clínicas de Porto Alegre were included. The patients had been submitted to vaginal palpation using the Oxford score, assessed by a skilled physical therapist, and to the compression force measurement by means of an air filled ballonet connected to a pressure transducer. The two evaluations had been carried in the same day.

Eligibility criteria: Inclusion Criteria:

* Stress, urge or mixed stress and urge urinary incontinence.
* Understanding and signing a letter of informed consent

Exclusion Criteria:

* Urinary tract infection.
* Genitourinary surgery during the previous six months.
* Pregnancy or in puerperal period.
* BMI \> 40

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Porto Alegre
country: Brazil
facility: Hospital de Clínicas de Porto Alegre
state: RS
Study officials:
affiliation: Hospital de Clnicas de Porto Alegre
name: José G Lopes ramos, Dr
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00197938: Lactic Acid in the Rectum and Life-Threatening Infection
Official title: Does the Concentration of L-Lactate in the Rectum Correlate With Mortality and Morbidity in Patients With Septic Shock?
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Septic Shock
Lead sponsor: Herlev Hospital
Sponsor class: OTHER
First posted: 2005-09-20
Enrollment: 130
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: Adult patients with early septic shock (\< 24 h).

Brief summary: Life-threatening infection impairs bloodflow to the gut, thereby causing less delivery of oxygen. This leads to increased formation of lactic acid.

The investigators hypothesize, that the more serious the condition, the higher the concentration of lactic acid will be, thus relating to the risk of multiple organ failure or death.


Eligibility criteria: Inclusion Criteria:

* Fluid resuscitated septic shock \< 24 h.

Exclusion Criteria:

* Septic shock \> 24 h.
* Pathology in the rectum.
* Bleeding per rectum.
* Limitation of therapy.
* Where informed consent from relatives cannot be obtained.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Dept. of Intensive Care 4131, Rigshospitalet
city: Glostrup
country: Denmark
facility: Dept. of Intensive Care, Glostrup University Hospital
city: Hellerup
country: Denmark
facility: Dept. of Intensive Care, Gentofte University Hospital
city: Herlev
country: Denmark
facility: Dept. of Intensive Care, Herlev University Hospital
city: Tampere
country: Finland
facility: Dept. of Intensive Care, Tampere University Hospital
Study officials:
affiliation: Dept. of Anaesthesia and Intensive Care, Herlev University Hospital, DK-2730 Herlev
name: Anders Perner, MD, PhD
role: STUDY_CHAIR
References:
citation: Ibsen M, Tenhunen J, Wiis J, Waldau T, Lauritsen AO, Thornberg K, Joensen H, Perner A. Lactate concentrations in the rectal lumen in patients in early septic shock. Acta Anaesthesiol Scand. 2010 Aug;54(7):827-32. doi: 10.1111/j.1399-6576.2010.02263.x. Epub 2010 Jun 15.
Clinical trial NCT00002138: A Phase I Trial of Tecogalan Sodium ( DS-4152 ) Administered as an Infusion Twice Weekly for 21 Days.
Official title: A Phase I Trial of Tecogalan Sodium ( DS-4152 ) Administered as an Infusion Twice Weekly for 21 Days.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Sarcoma, Kaposi
HIV Infections
Keywords: Neoplasms
Sarcoma, Kaposi
Acquired Immunodeficiency Syndrome
Antineoplastic Agents
tecogalan
Lead sponsor: NIH AIDS Clinical Trials Information Service
Sponsor class: INDUSTRY
First posted: 2001-08-31
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: To evaluate the safety of different doses and dosing regimens of tecogalan sodium (DS-4152) and to establish the MTD at each of the different dosing schedules.

Detailed description: Patients receive intravenous DS-4152 by infusion twice weekly for 21 days, followed by 2 weeks of rest; courses may repeat. Patients undergo weekly follow-up. A punch biopsy will be obtained from patients with Kaposi's sarcoma.

Eligibility criteria: Inclusion Criteria

Patients must have:

* Kaposi's sarcoma plus HIV infection OR metastatic solid tumor.
* Life expectancy of at least 12 weeks.
* NO symptomatic AIDS-defining opportunistic infection within the past 4 weeks.
* Recovered from toxicity of any prior anticancer therapy.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms or conditions are excluded:

* Leukemia or lymphoma.
* Current gastrointestinal bleeding by stool guaiac.
* Extensive bone metastases or significant radiographic osteoporosis in patients with solid tumors.
* Active heart disease such as uncontrolled angina, uncompensated congestive heart failure, or dysrhythmias requiring antiarrhythmics.
* Acute intercurrent infection other than genital herpes.
* Symptomatic or known central nervous system involvement (including brain metastases) unless stable and off therapy.

Concurrent Medication:

Excluded:

* Other anticancer therapy.
* Other investigational agents.

Patients with the following prior conditions are excluded:

* History of acute or chronic gastrointestinal bleeding or inflammatory bowel disease.
* History of myocardial infarction within past 6 months.

Prior Medication:

Excluded:

* Anticancer therapy within the past 3 weeks (6 weeks for nitrosourea or mitomycin C).
* Investigational agents within the past 4 weeks.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: Univ of California at San Francisco Gen Hosp
state: California
Study officials:
References:
Clinical trial NCT03350438: Participation in Occupations and Perception of Quality of Life, Comparing Adults With and Without PTSD
Official title: Participation in Everyday Occupations and Perception of Quality of Life-comparing Adults Eith PTSD With Typical Adults and Assessing the Relationship Between the Two Measures
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Post Traumatic Stress Disorder
Keywords: participation
quality of life
occupational therapy
Lead sponsor: Ziv Hospital
Sponsor class: OTHER_GOV
First posted: 2017-11-22
Enrollment: 80
Sex: MALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: men, age 18-60, Hebrew speaking, read and write in Hebrew, have been diagnosed with PTSD following a trauma that occurred over one year before the current study.

Brief summary: This study assesses the relationship between participation and quality of life the way adults with and without Post Traumatic Stress Disorder (PTSD) experience it in everyday life. Both groups will fill out Questionnaires and the answers will be compared. In addition different aspects of dissociation will be taken in to consideration.

Detailed description: Post Traumatic Stress Disorder has been known to severely impair participation in everyday activities such as work, recreation and social participation. In turn, these impairments can diminish quality of life. However, the relationship between PTSD, functioning and quality of life remains incompletely understood.

Since achieving full participation in daily activities is the main goal of occupational therapy, and since quality of life is a primary treatment success measure, it is important to fully understand the relationship between PTSD, participation and quality of life.

Various studies show that dissociation affects different body functions that manage and monitor mental functioning. Since quality of life is a subjective measure that relies on one's ability to mentally represent himself and others it is important to tack into consideration the way that dissociation affects the relationships described above.

The research contains 4 Questionnaires that will be filed out by the participants and the data from the Questionnaires will be analyzed and compared.

Eligibility criteria: Inclusion Criteria:

* Hebrew speaking, read and write in Hebrew, have been diagnosed with PTSD following a trauma that occurred over one year before the current study.

Exclusion Criteria:

* Other psychiatric disorders, cognitive or physical impairments.

Primary outcomes:
measure: self reported quality of life
timeFrame: two weeks
Secondary outcomes:
measure: Self Reported Dissociation
timeFrame: 24-48 hours
measure: self reported participation
timeFrame: 1 month
measure: self reported ptsd symptoms
timeFrame: 1 month
Other outcomes:
Locations:
city: Safed
country: Israel
facility: Ziv Hospital
state: Galilee
Study officials:
affiliation: Ziv Hospital
name: Lidia Isakson, PHD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06690138: A Study to Determine the Effect of Itraconazole on the Pharmacokinetics of Divarasib in Healthy Participants
Official title: A Phase 1, Open-Label, Single-Dose, Two-Period, Fixed Sequence, Crossover Study to Determine the Effect of Itraconazole on the Pharmacokinetics of Divarasib in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Participants
Lead sponsor: Genentech, Inc.
Sponsor class: INDUSTRY
First posted: 2024-11-15
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: This is a Phase 1, open-label, two-period, fixed sequence drug-drug interaction study to evaluate the impact of multiple doses of Itraconazole on the pharmacokinetics (PK) and safety of Divarasib in healthy participants.


Eligibility criteria: Inclusion Criteria:

* Males or females of non-childbearing potential
* Within body mass index (BMI) range of 18.0 to 32.0 kg/m2, inclusive

Exclusion Criteria:

* Significant history or clinical manifestation of any metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal (GI), neurological, or psychiatric disorder
* History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance, unless approved by the investigator
* Poor peripheral venous access

Primary outcomes:
measure: Maximum Plasma Concentration (Cmax) of Divarasib
timeFrame: Day 1 of Period 1 and Day 5 of Period 2
measure: Area Under the Concentration-time Curve from Hour 0 to the Last Measurable Concentration (AUC0-t) of Divarasib
timeFrame: Day 1 of Period 1 and Day 5 of Period 2
measure: Area Under the Concentration-time Curve Extrapolated to Infinity (AUC0-inf) of Divarasib
timeFrame: Day 1 of Period 1 and Day 5 of Period 2
Secondary outcomes:
measure: Percentage of Participants With Adverse Events (AEs)
timeFrame: Up to Week 12
Other outcomes:
Locations:
city: Dallas
country: United States
facility: Dallas Clinical Research Unit
state: Texas
Study officials:
affiliation: Genentech, Inc.
name: Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT02565238: BIO.MASTER.BioMonitor 2 Study
Official title: Master Study of the Insertable Cardiac Monitor BioMonitor 2.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Tachyarrhythmia
Atrial Fibrillation
Syncope
Lead sponsor: Biotronik SE & Co. KG
Sponsor class: INDUSTRY
First posted: 2015-10-01
Enrollment: 92
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The patient collective consists mainly of patients with indications of an insertable cardiac monitor or who are planned for loop recorded guided AF-therapy management. The investigator will select patients who are appropriate for particiation from his general patient population.

Brief summary: The objective of the study is to confirm safety and efficacy of the BioMonitor 2. The data is collected to support the regulatory approval of this product in countries outside the CE region.


Eligibility criteria: Inclusion Criteria:

* Patients without history of atrial fibrillation and with an indication for BioMonitor 2 device or paients planned for loop recorded guided AF-therapy management, with either current known and documented paroxysmal atrial fibrillation or with current known and documented persistent atrial fibrillation indicated for an ablation or was ablated within the last four weeks.
* Patient is able to understand the nature of the study and provides written informed consent.
* Patient is able and willing to complete the planned follow-up visits at the investigational site.
* Patient accepts the Home Monitoring® concept.
* Age is ≥ 18 years.

Exclusion Criteria:

* Patients implanted with ICD or pacemaker.
* Patient who is pregnant and/or breast-feeding or who intends to become pregnant during the time of the study will be excluded.
* Life expectancy of less than 6 months.
* Participation in another interventional clinical investigation. Participation in a non-interventional study is permitted.

Primary outcomes:
measure: Serious Adverse Device Effect (SADE)-free rate ≥ 90% related to BioMonitor 2
timeFrame: 3 month
Secondary outcomes:
measure: R-Wave amplitude ≥ 0.3 mV
timeFrame: 1 week
Other outcomes:
Locations:
Study officials:
affiliation: Heart Center Dresden, Germany
name: Christopher Piorkowski, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05267938: Microneedle Pretreatment as a Strategy to Improve the Effectiveness of Topical Anesthetics Formulations
Official title: Microneedle Pretreatment as a Strategy to Improve the Effectiveness of Topical Anesthetics Formulations
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Oral Cavity Disease
Keywords: Microneedles
Oral Cavity
Transbuccal administration
Lead sponsor: University of Campinas, Brazil
Sponsor class: OTHER
Collaborators: name: Texas Tech University
First posted: 2022-03-07
Enrollment: 30
Sex: MALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: A randomized, crossover, double-blind, two-sessions clinical trial with 30 male volunteers was performed to access pain of local anesthesia after using a topical anesthetic associated or not with prior application of microneedles to the palatal mucosa region

Detailed description: A randomized, crossover, double-blind, two-sessions clinical trial with 30 male volunteers was performed by applying a microneedle patch and as a negative control the an identical patch but without microneedles sticking out and after the topical anesthetic was applied for in one session 2 minutes and the other session 5 minutes and the investigators evaluated the pain of needle introduction and the injection of the anesthetic.

The application force of the microneedles was standardized to 10N by an applicator composed of a 5 mL syringe and a spring. Pain and discomfort associated to the procedure was evaluated with a Visual Analogue Scale (VAS), in these two different moments, introduction of the needle and injection of the anesthetic.

Eligibility criteria: Inclusion Criteria:

- Healthy male

Exclusion Criteria:

* Volunteers were free from cardiac, hepatic, renal, pulmonary, neurological, gastrointestinal and haematological diseases, psychiatric disorders, smokers or alcoholic.

Primary outcomes:
measure: Pain sensitivity assessment by Visual Analogue Scale after the after puncture and injection of local anesthetic
timeFrame: 2 minutes or 5 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Piracicaba
country: Brazil
facility: Michelle Franz Montan Braga Leite
state: São Paulo
Study officials:
References:
Clinical trial NCT04746508: Flat Foot and Coronal Spinopelvic Alignment
Official title: The Influence of Bilateral and Unilateral Flat Foot on Coronal Spinopelvic Alignment in Asymptomatic Young Healthy Males
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Flat Foot [Pes Planus] (Acquired), Left Foot
Flat Foot [Pes Planus] (Acquired), Right Foot
Flat Foot Acquired Bilateral (Pes Planus)
Pelvic Obliquity
Spinal Curvatures
Keywords: Flat foot
pelvic obliquity
spinal asymmetry
Cobb angle
calcaneal pitch angle
Lead sponsor: Hacettepe University
Sponsor class: OTHER
First posted: 2021-02-09
Enrollment: 360
Sex: MALE
Minimum age (years): 18
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy individuals who applied to the National Health Boards to work in positions requiring physical fitness between January 2018 and January 2019.

Brief summary: This study aimed to present the influence of unilateral and bilateral flat foot on coronal spinopelvic alignment in asymptomatic young healthy males. It will be carried out by examining the medical reports of individuals who apply to the National Health Board to work in positions requiring physical fitness between January 2018 and January 2019. Plain radiographies of the feet, pelvis, and spine will be analyzed. Calcaneal pitch angle (CPA) for flat foot, pelvic obliquity (PO), and Cobb angle (CA) for spinal asymmetry will be measured. After all analyzes were completed, participants will be divided into 2 groups as unilateral (UniFF) or bilateral (BiFF) flat foot, depending on the CPA measurements and will be compared.


Eligibility criteria: Inclusion Criteria:

* Body mass index (BMI) ranging between 18.5-24.9 kg/m2 (accepted as normal weight by World Health Organisation (WHO))
* Age ranging between 18-25 years
* Male gender

Exclusion Criteria:

* Being older than 25 years
* BMI out of normal weight according to WHO
* Being female
* History of spinal trauma/ surgery
* Having/had spinal disorders like spondylolisthesis, spondylodiscitis, etc.
* Having/had chronic inflammatory arthritis especially spodiloarthrosis (i.e., ankylosing spondylitis, psoriatic arthritis, etc.)
* Having/had a vertebral fracture
* Having/had aseptic necrosis of the vertebra
* Radiographs with inappropriate image qualities.

Primary outcomes:
measure: Calcaneal pitch angle (CPA)
timeFrame: Baseline
measure: Pelvic obliquity (PO)
timeFrame: Baseline
measure: The Cobb angle (CA
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Pınar Kısacık
Study officials:
affiliation: Hacettepe University Faculty of Physical Therapy and REhabilitation
name: Pınar Kısacık, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01760408: Sustain, A.S.P.E.N. HPN Registry 2011
Official title: SustainTM,LLC: A.S.P.E.N.'s National Patient Registry for Nutrition Care- Home Parenteral Nutrition
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Patients Requiring Home Parenteral Nutrition
Lead sponsor: Sustain, LLC of the American Society for Parenteral and Enteral Nutrition
Sponsor class: OTHER
First posted: 2013-01-04
Enrollment: 1600
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients receiving parenteral nutrition at home

Brief summary: The American Society for Parenteral and Enteral Nutrition (A.S.P.E.N.) developed a Web-based registry for nutrition care launched in early 2011, initially focusing on the home parenteral nutrition (HPN) patient population. The purpose of Sustain is to collect information regarding the patients and populations who require HPN in the United States, measure outcomes associated with HPN, allow institutional benchmarking against the aggregate data, and publish the findings to improve the quality of care for patients receiving HPN. The registry is open to all sites (hospital and home based) who care for new or existing HPN patients.


Eligibility criteria: Inclusion Criteria:must receive PN at home -

Exclusion Criteria:patients receiving PN in long-term care or as IDPN

-

Primary outcomes:
measure: catheter infection rate
timeFrame: per 1000 PN days
Secondary outcomes:
measure: rehospitalization rate
timeFrame: ongoing
Other outcomes:
Locations:
city: Silver Spring
country: United States
facility: A.S.P.E.N.
state: Maryland
Study officials:
References:
citation: Guenter P, Robinson L, DiMaria-Ghalili RA, Lyman B, Steiger E, Winkler MF. Development of Sustain: A.S.P.E.N.'s National Patient Registry for Nutrition Care. JPEN J Parenter Enteral Nutr. 2012 Jul;36(4):399-406. doi: 10.1177/0148607111432760. Epub 2012 Jan 26.
citation: Winkler MF, DiMaria-Ghalili RA, Guenter P, Resnick HE, Robinson L, Lyman B, Ireton-Jones C, Banchik LH, Steiger E. Characteristics of a Cohort of Home Parenteral Nutrition Patients at the Time of Enrollment in the Sustain Registry. JPEN J Parenter Enteral Nutr. 2016 Nov;40(8):1140-1149. doi: 10.1177/0148607115586575. Epub 2015 May 13.