louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05112016: Long-term Cohort Study of Mesorectal Excision for Rectal Cancer
Official title: Long-term Cohort Study of Mesorectal Excision for Rectal Cancer
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Rectum
Cancer
Keywords: TME (total mesorectal excision)
Transanal TME
Laparoscopic TME
Robotic TME
Open TME
Quality of life
Lead sponsor: Kantonsspital Winterthur KSW
Sponsor class: OTHER
First posted: 2021-11-08
Enrollment: 250
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: Patients with rectal cancer who benefit from surgical resection

Brief summary: The aim of this cohort study is to record, evaluate and compare the surgical, oncological as well as the functional outcome and Quality of life after mesorectal excision for rectal cancer

Detailed description: Outcomes of mesorectal excision patients will be analysed. Medical records will be reviewed and perioperative outcomes retrieved, incl. long-term oncological and functional/quality of life data. A retrospective cohort over 10 years (2007-2016) will serve as a control to a prospective cohort over 10 further years (2017-2026) as to investigate trends in perioperative and oncological outcomes (min. follow-up of 5 years + adequate cohort size). Prospective data on bowel function, urogenital function and quality of life will measured at time of diagnosis and further. Variations in neoadjuvant/adjuvant treatment and surgical approaches will be assessed for their effect on the outcomes of interest.

Eligibility criteria: Inclusion Criteria:

* Men and Women \>18 years
* Patients with rectal cancer
* Underwent mesorectal excision
* Agreed to fill in a validated questionnaires before surgery and after stoma reversal
* Informed consent

Exclusion Criteria:

* Age \< 18
* No informed consent (no general consent, no consent to use personal data for research purpose)

Primary outcomes:
measure: Perioperative mortality
timeFrame: 90 days
measure: Age
timeFrame: 10 years
measure: Body mass index
timeFrame: 10 years
measure: Gender
timeFrame: 10 years
measure: ASA score
timeFrame: 10 years
measure: Date of surgery
timeFrame: day of surgery
measure: Tumor localisation
timeFrame: 10 years
measure: Comorbidities
timeFrame: day of surgery
measure: Perioperative complications
timeFrame: 90 days
measure: Histological results
timeFrame: 30 days
measure: Quality of life, including functional and symptom scales, incontinence scores, sexual function
timeFrame: 10 years
Secondary outcomes:
measure: Perioperative treatment
timeFrame: 10 years
measure: Surgery time
timeFrame: day of surgery
measure: Length of hospital stay
timeFrame: 90 days
measure: Readmission rate
timeFrame: 90 days
measure: Costs
timeFrame: 10 years
Other outcomes:
Locations:
city: Winterthur
country: Switzerland
facility: Kantonsspital Winterthur
state: Zürich
Study officials:
affiliation: Kantonsspital Winterthur KSW
name: Michel Adamina, Prof/MD/MSc
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01436916: Oral Cholecalciferol in Prevention of Type 2 Diabetes Mellitus
Official title: Oral Cholecalciferol in Prevention of Type 2 DM in Prediabetic Population With Vitamin D Insufficiency
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Prediabetes
Vitamin D Deficiency
Keywords: prediabetes
oral cholecalciferol
Lead sponsor: PIMERIndia
Sponsor class: UNKNOWN
First posted: 2011-09-20
Enrollment: 50
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Type 2 diabetes mellitus (T2DM) is a major public health problem .Prevalence of vitamin D deficiency is also high i.e. 78-96% in different groups of population in north India. Observational studies find association between low Vitamin D status and type 2 diabetes mellitus. Prediabetes is a condition that progress to diabetes at a rate of 6-10% per year .There is mechanistic support that vitamin D may influence both insulin secretion and insulin sensitivity and subsequently T2DM incidence. In general, cross-sectional and prospective studies support the role of vitamin D in the prevention of T2DM. This study will be a single blind randomized placebo controlled trial to study the effect of oral cholecalciferol in insulin sensitivity and secretion in adults with prediabetes who are also vitamin D insufficient.


Eligibility criteria: Inclusion Criteria:

* Adults \> 20 years
* Impaired fasting glucose (IFG) - FPG 100-125 mg/dl
* Impaired glucose tolerance((IGT)- 2hr PPG 140-199mg/dl

OR

* both ( IFG +IGT)
* with or without Hb A1c -5.7-6.4 %

WITH

* Asymptomatic Vitamin D deficiency(\< 20ng/ml) or vitamin D in sufficiency(\< 32ng/ml)

Exclusion Criteria:

* Diabetes mellitus,
* Base line 25(OH)D3 \> 32 ng/ml,
* Symptomatic vitamin D deficiency,
* Any medication within last month that could affect insulin secretion, insulin sensitivity , vitamin D and calcium metabolism
* Chronic renal , hepatic ,malignant, intestinal or endocrine diseases
* Febrile illness or infective morbidity in last 2 weeks,
* Grossly deranged liver and kidney function

Primary outcomes:
measure: Change in insulin sensitivity using OGIS (oral glucose insulin sensitivity index)
timeFrame: Base line and 6 months
Secondary outcomes:
measure: change in indices of insulin secretion using HOMA1-beta% and HOMA2-beta %
timeFrame: Base line and 6 months
measure: change in other insulin sensitivity indices
timeFrame: Base line and 6 months
measure: Change in Hb A1c
timeFrame: Base line and 6 months
measure: Change in fasting and post prandial blood glucose
timeFrame: 0,3, 6months
Other outcomes:
Locations:
city: Chandigarh
country: India
facility: PGIMER
state: Chandigarh(UT)
Study officials:
affiliation: PGIMER
name: Anil Bhansali, MD, DM
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02740816: Comparative Study of Menstrual Blood and Systemic Blood
Official title: Comparative Study of Menstrual Blood and Systemic Blood: Quantifying the Difference
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Retention; Menstruation
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2016-04-15
Enrollment: 35
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy menstruating women.

Brief summary: The purpose is to investigate how menstrual blood differs from systemic blood to evaluate if menstrual blood could be utilized as a natural and non-invasive access to blood for regular health monitoring and early diagnostics.


Eligibility criteria: Inclusion Criteria:

* Age 18-45

Exclusion Criteria:

* weigh less then 110 pounds
* currently on a birth control method

Primary outcomes:
measure: Health Markers in Systemic Blood vs. Menstrual Blood
timeFrame: Up to 2 months
Secondary outcomes:
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University
state: California
Study officials:
affiliation: Stanford University, Department of OB/GYN
name: Paul D Blumenthal, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04382716: Pediatric Acute-Onset Neuropsychiatric Syndrome (PANS): Clinical Characterization and Prospective Course
Official title: Pediatric Acute-Onset Neuropsychiatric Syndrome (PANS): Clinical Characterization and Prospective Course
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: PANS
PANDAS
Lead sponsor: University of Minnesota
Sponsor class: OTHER
First posted: 2020-05-11
Enrollment: 22
Sex: ALL
Minimum age (years): 4
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children with an established or suspected diagnosis of PANS/PANDAS.

Brief summary: This study is a brief (3 month) longitudinal study following children between the ages of 4-16 years old who have been diagnosed with Pediatric Acute-Onset Neuropsychiatric Syndrome (PANS). Parents and children (who are at a 2nd grade reading level) will complete questionnaires online or in person weekly for 3 months. Additionally, parents will track their child's symptoms 3 times/week using a mobile application for 3 months. The investigators are hoping to begin to characterize the longitudinal trajectory of neuropsychiatric symptoms in children with PANS. Additionally, the study will seek to identify baseline demographic and clinical characteristics (e.g., gender, recent onset versus chronic course, GAS versus other triggers) that predict severity of baseline neuropsychiatric symptoms and predict change in symptoms over time.


Eligibility criteria: Inclusion Criteria:

* English-speaking boys and girls ages 4-16 years
* Abrupt onset of OCD or severely restricted food intake
* At least 2 equally abrupt-onset concurrent neuropsychiatric symptoms from the following 7 categories: anxiety, emotional lability/depression, irritability/aggression/severely oppositional behaviors, behavioral/developmental regression, deterioration in school performance, sensory or motor abnormalities (e.g. tics), somatic symptoms (e.g., urinary, sleep)
* Neuropsychiatric symptoms are not better explained by a known neurological or medical disorder.

Exclusion Criteria:

- Too unstable psychiatrically or medically to participate safely in the protocol, per clinical judgment of the Principal Investigator or Co-Investigator

Primary outcomes:
measure: Pediatric Acute-Onset Neuropsychiatric Syndrome (PANS) Symptom Rating Scale Compliance
timeFrame: Week 12
measure: Pediatric Acute-Onset Neuropsychiatric Syndrome (PANS) Symptom Rating Scale Agreement
timeFrame: Week 12
measure: Pediatric Acute-Onset Neuropsychiatric Syndrome (PANS) Symptom Rating Scale Predictors
timeFrame: Week 12
Secondary outcomes:
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
Study officials:
References:
citation: Harris EC, Conelea CA, Shyne MT, Bernstein GA. Predictors and Prospective Course of PANS: A Pilot Study Using Electronic Platforms for Data Collection. J Child Adolesc Psychopharmacol. 2021 Mar;31(2):102-108. doi: 10.1089/cap.2020.0124. Epub 2020 Dec 31.
Clinical trial NCT00517816: A Single Ascending Dose Study of R1671 in Patients With Mild Intermittent Asymptomatic Asthma.
Official title: A Randomized, Double-blind, Single Ascending Dose Study to Investigate the Safety, Tolerability, Pharmacokinetics and Effect on Pharmacodynamic Biomarkers of an Intravenous Infusion of R1671 in Patients With Mild, Intermittent Asymptomatic Asthma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Asthma
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2007-08-17
Enrollment: 43
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This 8 arm study will evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of single ascending doses of R1671 or placebo in patients with mild, intermittent, asymptomatic asthma. Patients will be randomized to receive placebo or R1671, at a starting dose of 0.0015mg, by intravenous infusion; this dose will be escalated in subsequent groups of patients after a satisfactory assessment of the data from the previous dose. The anticipated time on study treatment is \<3 months, and the target sample size is \<100 individuals.


Eligibility criteria: Inclusion Criteria:

* adult patients, 18-50 years of age;
* mild, intermittent, asymptomatic asthma;
* history of asthma for \>=6 months;
* non-smokers.

Exclusion Criteria:

* females of childbearing potential, or lactating;
* history of immunologically medicated disease;
* systemic antineoplastic or immunomodulatory treatment in past 6 months.

Primary outcomes:
measure: AEs, laboratory parameters, vital signs, ECG.
timeFrame: Throughout study
measure: Serum concentration of R1671, and serum pharmacokinetic parameters.
timeFrame: Throughout study
Secondary outcomes:
measure: Pharmacodynamic biomarker sampling; skin prick test.
timeFrame: At intervals during study
Other outcomes:
Locations:
city: Little Rock
country: United States
state: Arkansas
city: North Hollywood
country: United States
state: California
city: Port Orange
country: United States
state: Florida
city: Normal
country: United States
state: Illinois
city: Madisonville
country: United States
state: Kentucky
city: North Dartmouth
country: United States
state: Massachusetts
city: Morrisville
country: United States
state: North Carolina
city: San Antonio
country: United States
state: Texas
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT05287516: Validation of a Digital Visual Analogue Scale for Appetite Measurement
Official title: Use of a Digital Visual Analog Scale With Smart Phones for Appetite Measures in the Real World: A Validation Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Lead sponsor: General Mills
Sponsor class: INDUSTRY
First posted: 2022-03-18
Enrollment: 130
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The objective of the study is to validate a newly developed digital visual analog scales with a mobile app for measuring human appetite and compare it with a traditional paper-based visual analog scales for appetite measurement.


Eligibility criteria: Inclusion Criteria:

* Healthy adults 18-70 years.
* Body mass index 20-29.9 kg/m² (based on self-reported weight and height).
* Understand the study procedures.
* Willing to maintain habitual diet, physical activity pattern, and body weight throughout the trial.
* Willing to follow study procedures on test days.
* Willing to abstain from strenuous exercise, consuming alcoholic drinks 24 hours before the test day.
* Willing to provide informed consent to participate in the study.

Exclusion Criteria:

* Pregnant or lactating women, or women who are planning to become pregnant during the study
* Known food allergies, sensitivity, or intolerance to any food or food ingredients
* Participating in another clinical trial for food, investigational drug, nutritional supplement, or lifestyle modification
* Taking medications that affect appetite, metabolism, or blood pressure
* Presence of acute diseases or infection
* Presence or history of chronic diseases
* Diagnosed with eating disorders
* Restraint eaters
* Lost or gained 5 pounds or more in the past 3 months
* On a weight-loss diet, or undergoing intermittent fasting
* COVID-19 infection in the past 3 months.

Primary outcomes:
measure: Area Under the Curve for Hunger 0-240 min
timeFrame: 0-240 min
measure: Area Under the Curve for Fullness 0-240 min
timeFrame: 0-240 min
measure: Area Under the Curve for Desire to Eat 0-240 min
timeFrame: 0-240 min
measure: Area Under the Curve for Prospective Consumption 0-240 min
timeFrame: 0-240 min
measure: Area Under the Curve for Satiety 0-240 min
timeFrame: 0-240 min
Secondary outcomes:
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: Remote study, No physical facility
state: Minnesota
Study officials:
References:
Clinical trial NCT06648616: Impact of Elastic Band Resistance Training on Female Football Performance: A Pilot Study
Official title: Evaluating the Effects of Elastic Bands Resistance Training on Performance Parameters in Female Football Players: A Pilot Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Physical Perfrormance Parameters
Lead sponsor: University Institute of Maia
Sponsor class: OTHER
First posted: 2024-10-18
Enrollment: 10
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The goal of this clinical trial is to assess the effects of a 6-week strength training program with elastic bands on several physical components in adult female football players. The main question it aims to answer is:

Will a specific elastic band resistance training help improve some components of physical performance in adult female football players?

Participants will perform a bi-weekly elastic band resistance training, during a period of 6-weeks. This program will be incorporated into their in-season regimen, before their training session.


Eligibility criteria: Inclusion Criteria:

* be over 18 years of age;
* belong in the senior level of an amateur or professional women´s football club;
* play in one of the three Portuguese national women´s football leagues.

Primary outcomes:
measure: Knee extension and flexion isometric strength
timeFrame: At the beginning and end of the study (Week 1 and Week 6)
measure: Vertical jump
timeFrame: At the beginning and end of the study (Week 1 and Week 6)
measure: Change of direction sprint
timeFrame: At the beginning and end of the study (Week 1 and Week 6)
Secondary outcomes:
Other outcomes:
Locations:
city: Maia
country: Portugal
facility: University of Maia
state: Porto
Study officials:
References:
Clinical trial NCT05777616: The Impact of Medication Belief on Adherence to Infliximab in Patients With Crohn's Disease
Official title: The Impact of Medication Belief on Adherence to Infliximab in Patients With Crohn's Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Inflammatory Bowel Diseases
Keywords: Crohn's disease; adherence; medication concern; infliximab
Lead sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Sponsor class: OTHER
First posted: 2023-03-21
Enrollment: 166
Sex: ALL
Minimum age (years): 14
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study was conducted at the Second Affiliated Hospital, Zhejiang University School of Medicine (SAHZU) from November 15 to December 28, 2021. All CD patients treated with infliximab were retrospectively identified in the electronic medical records (EMRs) from the SAHZU Crohn's and Colitis Center.

Brief summary: The IFX adherence to CD in China was not high. Medicine concerns may be predictive factor of adherence. By enhancing knowledge and relieving medicine concerns, we may increase patients' adherence to IFX.

Detailed description: Crohn's disease (CD) is an incurable chronic disease that requires long-term treatment. As an anti-tumor necrosis factor (TNF) agent, Infliximab (IFX) is widely used in the treatment of Crohn's disease, while the adherence is not high. The purpose of this study was to investigate the adherence to IFX among CD patients in China and evaluate the association between medication belief and IFX adherence.

Eligibility criteria: Inclusion Criteria:

* patients with a confirmed diagnosis of CD; were treated with infliximab for at least 12 weeks; were informed consent.

Exclusion Criteria:

* The exclusion criteria were received treatment from mental health professionals due to any mental or cognitive impairment; suffered from other serious diseases, such as heart, brain, lung, liver and kidney dysfunction; severe infection, anemia, cachexia or other serious complications were found.

Primary outcomes:
measure: Adherence
timeFrame: November 15 to December 28, 2021
Secondary outcomes:
Other outcomes:
Locations:
city: Zhejiang
country: China
facility: 2ndAffiliated Hospital, School of Medicine, Zhejiang University, China
Study officials:
affiliation: 2nd Affiliated Hospital, School of Medicine, Zhejiang University,China
name: Yan Chen
role: STUDY_DIRECTOR
References:
Clinical trial NCT00927316: E. Coli 83972 Induced Asymptomatic Bacteriuria (ABU) in Patients With Recurrent Urinary Tract Infections (UTI)
Official title: Induced Asymptomatic E. Coli 83972 Bacteriuria in Patients With Recurrent Urinary Tract Infections and Bladder Dysfunction- is There a Protective Effect Against Recurrent Symptomatic Infections? A Blinded Placebo Controlled Cross-over Study.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Urinary Tract Infection
Keywords: Report of Urinary Tract Infection episode
Lead sponsor: Region Skane
Sponsor class: OTHER
Collaborators: name: Coloplast A/S
name: Riksförbundet för Trafik, Olycksfall och Polioskadade (RTP), Sundbyberg, Sweden
name: Swedish Institute for Infectious Disease Control
name: Lund University Hospital
First posted: 2009-06-24
Enrollment: 30
Sex: ALL
Minimum age (years): 20
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: This study tests the following hypothesis: Does induced asymptomatic bacteriuria (E. coli 83972) protect against symptomatic urinary tract infections in individuals with bladder emptying dysfunctions and prone to recurrent infection episodes? The study is performed using a double-blind randomized study protocol with a cross-over, with re-inoculations being patient-blinded (phase 1). After patients have fulfilled the cross-over, those who have had bacteriuria or placebo-periods \< 12 months will be subjected to additional patient blinded inoculations (phase 2). During the entire study (phase 1+2) the study-team and the patients are unaware of urine culture results.


Eligibility criteria: Inclusion Criteria:

* Recurrent UTI
* Bladder emptying dysfunction
* Optimal conservative treatment incl. clean intermittent catheterization
* Capable of "self reporting of UTI episodes"

Exclusion Criteria:

* Malignant disease
* Immunosuppression
* Recurrent pyelonephritis
* Abnormalities within upper urinary tract, including renal stones and poor kidney function

Primary outcomes:
measure: Time to UTI
timeFrame: 12 months
measure: Number of UTI
timeFrame: During 12 months placebo or active treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Lund
country: Sweden
facility: Department of Urology, Lund University
Study officials:
affiliation: Dept. of Urology, University Hospital, 221 85 Lund
name: Fredrik Sundén, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Dept. of Urology, Lund University Hospital, 221 85 Lund
name: Björn Wullt, MD, PhD
role: STUDY_CHAIR
References: