louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03663231: Duration of Effect of Biotene Spray in Patients With Dry Mouth
Official title: Duration of Effect of Biotene Spray in Patients With Symptomatic Dry Mouth
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dry Mouth
Lead sponsor: University of Rochester
Sponsor class: OTHER
First posted: 2018-09-10
Enrollment: 37
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: To determine the duration of effect of a single dose of Biotène Moisturizing Mouth Spray in subjects who complain of a clinically dry mouth. The effect of the product will be compared to a control spray (water).


Eligibility criteria: Inclusion Criteria:

* Adults who are in good general health and reply initially affirmatively to the question, "Do you feel that your mouth is too dry and causes you discomfort at times during the day other than on awakening from sleep?" This question is an adaptation of the question used successfully by Jose and others (2016) to recruit study subjects.
* Adults who are able to communicate easily in English and who are able to demonstrate understanding of the study instructions.
* Adults who are physically able to perform an unstimulated whole saliva flow rate (UWSFR) test and who produce 0.2 mL/min or less of saliva.

Exclusion Criteria:

* Adults under the care of a health professional specifically for xerostomia treatment, including those taking prescription systemic parasympathetic medications.
* Adults who regularly "self-medicate" their xerostomia with water or other agents or products designed to treat their xerostomia and are unwilling or unable to cease use of the agent for at least 48 hours prior to the two test visits.
* Adults who are primarily mouth breathers (i.e. mouth breathing secondary to nasal obstruction)
* Adults who cannot consent for themselves or have physical/mental disabilities requiring a caregiver.
* Adults with a known allergy to any of the ingredients in Biotène Spray (eg. dairy allergy)

Primary outcomes:
measure: Mean Duration of Action of Intervention
timeFrame: baseline up to 2 hours
Secondary outcomes:
measure: Mean Tolerability of Product
timeFrame: 2 hours
measure: Mean Acceptability of Product
timeFrame: 2 hours
measure: Mean Continued Use of Project
timeFrame: 2 hours
measure: Mean Purchase Product Rating
timeFrame: 2 hours
measure: Mean Ease of Use of Product
timeFrame: 2 hours
measure: Mean Preference for Another Product
timeFrame: 2 hours
Other outcomes:
Locations:
city: Rochester
country: United States
facility: University of Rochester Eastman Dental Center
state: New York
Study officials:
References:
citation: Lung CB, Watson GE, Verma S, Feng C, Saunders RH. Duration of effect of Biotene spray in patients with symptomatic dry mouth: A pilot study. Oral Surg Oral Med Oral Pathol Oral Radiol. 2021 Apr;131(4):415-421. doi: 10.1016/j.oooo.2020.12.002. Epub 2021 Jan 16.
Clinical trial NCT01815931: Hemolysis in Blood Samples in the ER
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hemolysis
Emergency Service, Hospital
Emergencies
Blood Specimen Collection
Lead sponsor: University Hospital, Geneva
Sponsor class: OTHER
First posted: 2013-03-21
Enrollment: 2800
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All adult (\> 16 y) patients admitted in the emergency departement during the study period

Brief summary: In this study, we aim to identify risk factors for hemolysis in blood samples drawn in the ED.


Eligibility criteria: Inclusion Criteria:

* \> 16 years

Exclusion Criteria:

* In vivo hemolysis

Primary outcomes:
measure: Hemolysis rate
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Geneva
country: Switzerland
facility: University Hospital, Geneva
state: GE
Study officials:
References:
Clinical trial NCT06845631: Retrospective-Prospective PNS Study
Official title: Retrospective-Prospective Clinical Trial Investigating the Treatment of Chronic Pain With the Freedom Peripheral Nerve Stimulation System
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Chronic Pain
Keywords: chronic pain, PNS, Retrospective, prospective
Lead sponsor: Curonix LLC
Sponsor class: INDUSTRY
Collaborators: name: MetroHealth System, Ohio
First posted: 2025-02-25
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Retrospective/Prospective
Primary purpose: OTHER

Brief summary: This is a retrospective-prospective study in which 40 patients have received a permanent Freedom PNS System. Subjects presented with chronic, intractable pain of peripheral nerve origin refractory to standard medical and/or surgical treatment.

A retrospective chart review will be conducted to assess baseline and follow-up parameters in patients who have received a permanent implant with the Freedom PNS system for at least 12 months. Missing data might be collected after informed consent.


Eligibility criteria: Inclusion Criteria:

A. Subject is ≥ 18 years of age at time permanent implant; B. Subject has been implanted with the Freedom PNS system; C. Subject is willing to attend visit as scheduled, and comply with the study requirements (if prospective); D. Patient is capable of giving informed consent.

Exclusion Criteria:

A. Subject is currently enrolled in or plans to enroll in any concurrent drug and/or device study while participating in this study (if prospective); B. Any additional active implanted devices for the treatment of chronic pain in addition to the Freedom PNS system.

Primary outcomes:
measure: Pain scores
timeFrame: 12 months
Secondary outcomes:
measure: Opioids
timeFrame: 12 months
measure: Work status
timeFrame: 12 months
measure: GPES
timeFrame: 12 months
measure: Amount of sleep
timeFrame: 12 months
measure: Sleep disturbances
timeFrame: 12 months
measure: EQ-5D-5L
timeFrame: 12 months
measure: Claims data
timeFrame: 12 months
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: The Metrohealth System
state: Ohio
Study officials:
References:
Clinical trial NCT00824031: Study of Mental Care in Spain
Official title: Study of Mental Care in Spain
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Schizophrenia
Keywords: schizophrenia
medical mental care
caregiver
Sapin
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2009-01-16
Enrollment: 76
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient aged 18-year old or older who has been diagnosed as schizophrenia

Brief summary: Non-interventional, multicenter, cross-sectional study to evaluate the mental care received by schizophrenic patients and their caregivers in Spain irrespective of the drug prescribed.


Eligibility criteria: Inclusion Criteria:

* Schizophrenia (DSM-IV criteria)
* Attended to the mental care units for the first time in 2006

Exclusion Criteria:

* Participation in another clinical trial
* Other criteria that according to the medical criteria make difficult the normal development of the study

Primary outcomes:
measure: Camberwell's scale of Needs Analysis (CAN)
timeFrame: Once
measure: Caregiver Needs Questionnaire(CNF)
timeFrame: Once
Secondary outcomes:
measure: Health of the Nation Outcome Scales (HoNOS)
timeFrame: Once
Other outcomes:
Locations:
city: Ferrol
country: Spain
facility: Research Site
state: A Coruna
city: Aviles
country: Spain
facility: Research Site
state: Asturias
city: Jerez de la Frontera
country: Spain
facility: Research Site
state: Cadiz
city: Torrejon de Ardoz
country: Spain
facility: Research Site
state: Castellon
city: La Plana
country: Spain
facility: Research Site
state: Valencia
city: Bilbao
country: Spain
facility: Research Site
state: Vizcaya
city: Cordoba
country: Spain
facility: Research Site
city: Girona
country: Spain
facility: Research Site
city: Madrid
country: Spain
facility: Research Site
Study officials:
affiliation: University of Valencia
name: Manuel Gomez-Beneyto
role: STUDY_CHAIR
affiliation: Hospital Universitario Principe de Asturias
name: Alberto Gonzalez
role: STUDY_CHAIR
References:
Clinical trial NCT06642831: Polycystic Ovarian Syndrome (PCOS) Biomarker Evaluation Study
Official title: Polycystic Ovarian Syndrome (PCOS) in Human Adolescent and Young Adult Females - Biomarker Evaluation Study (PHOEBE)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Polycystic Ovarian Syndrome (PCOS)
Keywords: PCOS
biomarker
adolescents
Lead sponsor: University Hospital Erlangen
Sponsor class: OTHER
Collaborators: name: Roche Diagnostics International AG
First posted: 2024-10-15
Enrollment: 380
Sex: FEMALE
Minimum age (years): 15
Maximum age (years): 25
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adolescent and young adult women aged between the ages of 15 and 25 with and without PCOS who present at the Women's Clinic of the University Hospital Erlangen.

Brief summary: The purpose of the study is to validate recently identified biomarkers for the identification of PCOS in adolecent and young adult women.

Detailed description: The purpose of the study is to validate potential biomarkers for the aid in the diagnosis of PCOS in adolescent and young adult women in the age range of 15-25 years. Female subjects included in this study will have one visit where clinical data for assessing PCOS will be collected and a blood draw will be performed to collect serum for measurement of parameters relevant to PCOS will be performed. Study subjects that receive a PCOS diagnosis will have two follow up visits for follow up on treatment where additional serum and clinical data will be collected. The first visit will be 3 months after receiving the diagnosis and the second visit 6-12 months after the initial visit.

Eligibility criteria: Inclusion Criteria:

* Female subjects age 15-25 years
* Signed written informed consent

Exclusion Criteria:

* Less than 1 years from onset of menarche
* Use of hormonal contraceptives
* Documented ongoing pregnancy
* Major ovarian abnormalities, including subject with only one ovary, cysts and solid masses \> 2 cm as detected by transvaginal ultrasound
* Malignancy ( documented malignancy, documentation of current radiation therapy or chemotherapy in medical record)

Primary outcomes:
measure: The validation of new potential biomarkers for aid in the diagnoisis of PCOS in adolescent and young adult women
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Erlangen
country: Germany
facility: Department of Obstetrics and Gynecology, University Erlangen Hospital, Friedrich Alexander University of Erlangen-Nuremberg, Erlangen, Germany
Study officials:
affiliation: University Hospital Erlangen
name: Ralf Dittrich, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00064831: Black Cohosh Extract in Postmenopausal Breast Health
Official title: The Effect of Black Cohosh Extract on the Human Breast
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Menopause
Hot Flashes
Keywords: estrogen stimulation
relief of hot flashes
nipple aspirate fluid
body fluid levels of black cohosh
Lead sponsor: National Center for Complementary and Integrative Health (NCCIH)
Sponsor class: NIH
Collaborators: name: University of Missouri-Columbia
First posted: 2003-07-15
Enrollment: 73
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The purpose of the study is to determine if black cohosh extract (BCE) administration in symptomatic postmenopausal women results in estrogenic stimulation of the breast, as determined by estradiol, pS2, FSH, LH, and PSA levels in nipple aspirate fluid.

Detailed description: As in Brief Summary

Eligibility criteria: * Postmenopausal females
* 20 months since any breastfeeding
* Active postmenopausal symptoms, i.e., hot flashes
* At least 6 months since last menstrual period or have had a hysterectomy with both ovaries removed
* Able to make 4 visits during the trial to the study clinic in Columbia, Missouri

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Columbia
country: United States
facility: University of Missouri-Columbia
state: Missouri
Study officials:
affiliation: University of Missouri-Columbia
name: Edward Sauter, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00636831: Prophylactic Antibiotic Use in Hernioplasty
Official title: Prophylactic Antibiotic Use in Inguinal Hernioplasty: A Placebo-controlled, Double-blind Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Inguinal Hernia
Keywords: Prophylactic
Antibiotic
Infection
Primary case
Lead sponsor: Nihon University
Sponsor class: OTHER
First posted: 2008-03-17
Enrollment: 400
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to determine whether prophylactic antibiotic use in inguinal hernioplasty are effective in prevention of infectious complication.


Eligibility criteria: Inclusion Criteria:

* Primary inguinal hernia
* Elective surgery
* Must be older than 20 years of age
* Must not have any serious complication

Exclusion Criteria:

* Incarceration
* Recurrence
* Drug allergy
* Diabetes mellitus
* Malignant diseases
* Serious heart diseases
* Psychological diseases
* Pregnancy
* Have been medicated with corticosteroids

Primary outcomes:
measure: infectious complication
timeFrame: two year
Secondary outcomes:
measure: Recurrence of inguinal hernia
timeFrame: two year
Other outcomes:
Locations:
city: Tokyo
country: Japan
facility: Nihon University School of Medicine, Department of Surgery
Study officials:
References:
Clinical trial NCT05289531: (LARS) Score Validation of Turkish Language
Official title: Validation of the Turkish Translation of the Low Anterior Resection Syndrome (LARS) Score
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: LARS - Low Anterior Resection Syndrome
Keywords: Turkish LARS
Lead sponsor: Ankara University
Sponsor class: OTHER
Collaborators: name: Aarhus University Hospital
name: Dokuz Eylul University
name: Lokman Hekim Üniversitesi
First posted: 2022-03-21
Enrollment: 222
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients had their surgeries performed by expert colorectal surgeons with at least 15 years of experience and performing more than 20 rectal cancer surgeries in a year to minimize surgeon-related hazards for poor functional outcome. The first rectal resection with a diverting ileostomy in the study group was performed in May 2000, which was closed in January 2001, and the last stoma closure was in September 2018. All patients had their bowel continuity restored for at least 6 months prior to completing the survey.

Brief summary: Long-term bowel dysfunction after resection for rectal cancer, known as low anterior resection syndrome (LARS), is observed in many patients. The LARS score was developed to measure this syndrome and its impact on quality of life in Danish patients. Recently, English and many other language versions have been validated. The aim of this study was to validate the Turkish translation of the LARS score in Turkish patients who have undergone treatment for rectal cancer.

Detailed description: A total of 326 patients were reviewed and contacted for the study, and 222 (68%) were eligible for the analyses. The association between the LARS score and quality of life and the test-retest reliability were studied. The intraclass correlation coefficient (ICC) was calculated to understand the degree of reliability.

Eligibility criteria: Inclusion Criteria:The inclusion criteria were

* rectal adenocarcinoma within 15 cm from the anal verge
* LAR with either PME or TME.
* Bowel continuity restored for at least 18 months when invited for the study.

Exclusion Criteria:Exclusion criteria included

* failed R0 surgery,
* recurrence or dissemination,
* having intestinal stoma,
* previous cancer (except minor skin cancers)
* dementia and inability to speak Turkish (i.e., the need for a translator during treatment).

Primary outcomes:
measure: Validity of LARS Score
timeFrame: From Feb 2016 to Feb 2020
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02788331: Trends in Volume-Outcome Relationship in Surgery
Official title: Revisiting the Volume-outcome Relationship in Surgery: Trends Analysis in French Hospitals
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Surgical Procedures
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2016-06-02
Enrollment: 759518
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients operated in French public and private hospitals from January 2010 to December 2014

Brief summary: The explanatory mechanism of the relationship between the volume of surgical procedures performed by individual hospitals and the occurrence of serious adverse events is not clear. Based on the " practice makes perfect " dogma, we will explore whether a learning effect can explain the volume-outcome relationship for complex surgical procedures using a nationwide dataset. Especially, we assume that increasing volume of procedures over time may be associated with improved outcomes.


Eligibility criteria: Inclusion Criteria:

All adults hospitalized to have one of the following major surgery: resection of oeso-gastric, intestinal and pancreatic cancer, treatment of intra-abdominal aortic aneurysm, coronary artery bypass graft, endarterectomy, hip fracture prosthesis

Exclusion Criteria:

* Hospitalization \<24 hours
* Absence of surgical procedure
* Ambulatory care
* Palliative care
* Organ transplantation

Primary outcomes:
measure: Inpatient mortality
timeFrame: Within 30 days of surgical procedure
Secondary outcomes:
measure: Reoperation occurence
timeFrame: Within 30 days of surgical procedure
measure: Occurence of intensive or critical care unit stay
timeFrame: Within 30 days of surgical procedure
measure: Occurence of postoperative complication
timeFrame: Within 30 days of surgical procedure
measure: Occurence of unplanned hospital readmission
timeFrame: Within 30 days of hospital discharge related to index stay
Other outcomes:
Locations:
city: Lyon
country: France
facility: Pôle Information Médicale Evaluation Recherche des Hospices Civils de Lyon
Study officials:
affiliation: Hospices Civils de Lyon
name: Antoine DUCLOS, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Payet C, Polazzi S, Lifante JC, Cotte E, Grinberg D, Carty MJ, Sanchez S, Rabilloud M, Duclos A. Influence of trends in hospital volume over time on patient outcomes for high-risk surgery. BMC Health Serv Res. 2020 Apr 1;20(1):274. doi: 10.1186/s12913-020-05126-4.
Clinical trial NCT02560831: Effects of Therapeutic Exercises in Elderly Women With Knee Osteoarthritis
Official title: Assessment of the Effects of Therapeutic Exercises Associated With Pompage Technique on Pain, Muscle Strength and Postural Balance in Older Women With Knee Osteoarthritis: a Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteoarthritis
Keywords: Osteoarthritis
Therapeutic exercises
Pain
Muscle strength
Postural balance
Lead sponsor: Universidade Federal de Pernambuco
Sponsor class: OTHER
First posted: 2015-09-25
Enrollment: 22
Sex: FEMALE
Minimum age (years): 60
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Knee Osteoarthritis is a degenerative disease associated with muscle weakness, arthralgia, rigidity and postural instability. Therapeutic exercise can reduce pain and improve muscle strength and postural balance, however benefits from association with pompage is not known. This study aims to evaluate the effects of therapeutic exercise on pain, muscle strength and postural balance in elderly women with knee osteoarthritis. Methodology: Almost randomized controlled trial, in which were included elderly between 60 and 80 years diagnosed with knee osteoarthritis, randomized into two groups with 11 participants each. Intervention group held strengthening exercises for flexors and knee extensors, balance training, and manual knee pompage for 12 weeks. Control Group received educational lectures. Arthralgia was estimated by pain subscale of the questionnaire Western Ontario McMaster Universities Osteoarthritis Index and (WOMAC); muscle strength was assessed by the isokinetic dynamometer HUMAC® NORM Testing \& Rehabilitation System and the postural balance by the Biodex Balance SD postural stability protocol (Biodex Medical Systems, Inc. New York, USA). The Student t test was used for statistical analysis.


Eligibility criteria: Inclusion Criteria:

* Female
* Aged between 60 and 80 years
* Diagnosed with knee's osteoarthritis according to clinical and radiographic criteria of the American College of Rheumatology.

Exclusion Criteria:

* Cardiovascular and/or unstable respiratory diseases
* Knee or hip arthroplasty; in the last 6 months: surgery on lower limbs, intraarticular corticosteroid injection in the knee, physical therapy
* Associated diseases that contribute to the balance disorders (for example ankylosing spondylitis, rheumatoid arthritis, diabetes mellitus, neurological diseases, Parkinson's disease, cerebral palsy and vestibular).

Primary outcomes:
measure: The concentric muscular peak torque of the knee extensors
timeFrame: 3 months
measure: Postural stability
timeFrame: 3 months
Secondary outcomes:
measure: Level of knee's pain
timeFrame: 3 months
Other outcomes:
Locations:
Study officials:
References: