louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05434377: A Study of Fixed Dose Versus Serum Level-Based Titration Regimen of Vitamin D Supplementation in Dialysis Patients
Official title: A Randomized Study Comparing Between Fixed Dose and Serum Level-Based Titration Regimen of Vitamin D Supplementation Among Dialysis Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Vitamin D Deficiency
End Stage Renal Disease
Keywords: vitamin D insufficiency
dialysis
ergocalciferol
Lead sponsor: Chulalongkorn University
Sponsor class: OTHER
First posted: 2022-06-28
Enrollment: 78
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Vitamin D insufficiency, defined as serum 25-hydroxyvitamin (OH) D level less than 30 ng/ml, is highly prevalent not only in the general population but also in chronic kidney disease (CKD) population. Many guidelines including the National Kidney Foundation-Kidney Disease Outcomes Quality Initiative (NKF-KDOQI) have consistently recommended vitamin D supplementation in patients with pre-dialysis CKD with vitamin D insufficiency with ergocalciferol or cholecalciferol to achieve 25(OH)D level of more than 30 ng/ml using serum levels-based titration regimen. However, this protocol has not been studied in end stage kidney disease patients treated with maintenance dialysis.

Detailed description: The investigators plan to conduct a randomized study comparing the two different protocols between serum 25(OH)D level-based titration regimen and fixed dose of ergocalciferol supplementation among dialysis patients for a total period of 6 months. At the study completion, investigators also plan to compare the proportion of participants achieving serum 25(OH)D of more than 30 ng/ml, CKD-related metabolic and bone parameters as well as non-skeletal effect of vitamin D supplementation for each group.

Eligibility criteria: Inclusion Criteria:

* age \> 18 years
* on maintenance dialysis (hemodialysis or peritoneal dialysis) \> 3 months
* 25(OH)D \< 30 ng/ml
* able to provide inform consent form

Exclusion Criteria:

* current ergocalciferol or cholecalciferol treatment
* known allergy to ergocalciferol
* active inflammation or infection
* advanced stage of cancer
* pregnancy
* lactation
* on immunosuppressive drugs or corticosteroids

Primary outcomes:
measure: proportion of patients with vitamin D adequacy
timeFrame: 6 months
Secondary outcomes:
measure: serum calcium
timeFrame: 6 months
measure: serum phosphorus
timeFrame: 6 months
measure: serum intact parathyroid hormone
timeFrame: 6 months
measure: muscle mass
timeFrame: 6 months
measure: muscle strength
timeFrame: 6 months
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Chulalongkorn Univeristy
Study officials:
affiliation: Chulalongkorn University
name: Piyawan Kittiskulnam
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01098877: First In Human Study Of Increasing Oral Doses Of PF-04634817
Official title: A Double Blind, Randomized, Placebo Controlled, Dose Escalation Study To Investigate The Pharmacokinetics (In The Fed And Fasted State), Safety And Toleration Of Single Oral Doses Of PF-04634817 In Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Phase1
pharmacokinetics
safety
toleration
pharmacodynamics
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2010-04-05
Enrollment: 27
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The study will evaluate the hypothesis that at doses and plasma concentrations which affect pharmacodynamic markers of activity at the chemokine receptors, CCR2 and CCR5, the compound is safe and well tolerated. It will also evaluate the hypothesis that the pharmacokinetic profile is robust and consistent with a once or twice a day therapeutic administration.


Eligibility criteria: Inclusion Criteria:

* Healthy male or female (of non-child bearing potential) subjects between 18 and 55 years of age.
* Body mass index of 17.5 to 30.5 kg/m2 and total body weight \> 50kg.

Exclusion Criteria:

* Evidence or history of any clinically significant disease.
* Treatment with an investigational drug within 30 days of study start
* Use of prescription and non-prescription medicines within 7 days of study start

Primary outcomes:
measure: Safety and toleration: adverse events, supine and standing vital sign measurements, telemetry, 12-lead ECGs, blood and urine tests
timeFrame: 0-3 days
measure: Plasma pharmacokinetics: Cmax, Tmax, AUClast, AUCinf, AUC0-24, CL/F, Vz/F and T1/2
timeFrame: 0-4 days
measure: Urinary pharmacokinetics: Aet (mount excreted in urine), Aet% and CLr
timeFrame: 0-2 days
measure: p-ERK inhibition in human monocytes
timeFrame: 0-3 days
measure: Change in circulating monocytes
timeFrame: 0-3 days
Secondary outcomes:
measure: Change from baseline in plasma MCP-1
timeFrame: 0-3 days
measure: MIP 1B stimulated CCR5 receptor internalization
timeFrame: 0-3 days
measure: MCP-1 stimulated CCR5 receptor internalization
timeFrame: 0-3 days
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Pfizer Investigational Site
state: Connecticut
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT04953377: PFMT Educational Intervention for Patients With Advancer Breast Cancer
Official title: Pelvic Floor Muscle Training Educational Intervention for Patients With Breast Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Advanced Breast Cancer
Keywords: pelvic floor muscle training
urinary incontinence
educational intervention
Lead sponsor: Onkologikoa
Sponsor class: OTHER
First posted: 2021-07-08
Enrollment: 42
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: A PFMT educational intervention was designed for women with metastasic breast cancer. It consisted in a 120 min workshop and 8 weeks of non-supervised (but with follow-up) self-training. ICIQ, IQOL and ad hoc questions were performed before the workshop and after the 8 weeks training to see the prevalence of UI, the impact in their quality of life and the empowerment of self-training.

Detailed description: Urinary incontinence (UI) affects women of all ages and has a great impact on the quality of life. Cancer treatments such as chemotherapy or hormone therapy may play an important rol in the development and worsening of pelvic floor disorders. Little evidence on the prevalence and impact of UI in metastassis breast cancer women is known.

A protocol was designed to analyze the effect of a PFMT educational intervention on the UI and the impact on the QoL, as well as in the empowerment feeling of the participants. Feasibility of the protocol will be analized to design an optimal RCT for testing our hypothesis

During the usual visits, oncologist wil recruit women with advanced breast cancer who meet the inclusion criteria for the participation.

Eligibility criteria: Inclusion Criteria:

* Advanced breast cancer
* Over 18 years old
* ECOG≤2
* No inestable bone metastasis
* life expentancy\>6 months
* Literate in spanish

Exclusion Criteria:

* Physical exercise contraindications
* Intense pain
* Being pregnant

Primary outcomes:
measure: Feasibility- Recruitment rates
timeFrame: 8 weeks
measure: Feasibility - Qualitative analyses of recruitment
timeFrame: 8 weeks
measure: Feasibility-Quantitative and qualitative retention log
timeFrame: 8 weeks
measure: Feasibility- Adherence to the program
timeFrame: 8 weeks
measure: Feasibility- Satisfaction with the workshop
timeFrame: baseline
measure: Prevalence of urinary incontinence
timeFrame: baseline
Secondary outcomes:
measure: Changes in urinary incontinence
timeFrame: 8 weeks
measure: Impact of urinary incontinence on the quality of life
timeFrame: 8 weeks
measure: Knowledge and empowerment
timeFrame: 8 weeks
Other outcomes:
Locations:
city: San Sebastián
country: Spain
facility: Onkologikoa
Study officials:
affiliation: Onkologikoa
name: Mireia Pelaez
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00812747: Surgical Wound Infections After Vascular Surgery: Prospective Multicenter Trial
Official title: Surgical Wound Infections After Vascular Surgery: Prospective Multicenter Trial
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Surgical Wound Infection
Keywords: surgical wound infection
risk factor
Lead sponsor: North Karelia Central Hospital
Sponsor class: OTHER
Collaborators: name: Kuopio University Hospital
name: South Carelia Central Hospital
name: South Savo Hospital District
First posted: 2008-12-22
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: All patients who underwent non-emergency infrarenal aortic or lower limb arterial surgery between June 2007 and January 2008 were enrolled to this study.

Brief summary: The purpose of this multicentre prospective trial is to determine the incidence and risk factors for surgical wound infections. Also the investigators will evaluate consequences of wound infections to the patients, and extra costs caused by wound infections.


Eligibility criteria: Inclusion Criteria:

* non-emergency infrarenal aortic or lower limb arterial surgery

Exclusion Criteria:

* patient's refusal to participate

Primary outcomes:
measure: wound infection incidence
Secondary outcomes:
Other outcomes:
Locations:
city: Joensuu
country: Finland
facility: North Karelia Central Hospital
Study officials:
References:
Clinical trial NCT04342247: Effects of External Testosteron Intake on the Choroid: Enhance-depth Imaging Optical Coherence Tomography Study
Official title: Effects of External Testosteron Intake on the Choroid: Enhance-depth Imaging Optical
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Effects of the External Testosteron Intake Over the Choroids of the Patients With Androgen Deficiency
Lead sponsor: Neon Hospital
Sponsor class: OTHER
First posted: 2020-04-10
Enrollment: 30
Sex: ALL
Minimum age (years): 30
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: randomly selected subjects aged between 30 and 800

Brief summary: According to the results Ciloğlu et al., CSC is related to elevated total testosterone levels. Testosterone may play a role in predisposing males to CSC. Thus, we aimed to investigate the possible effect of external testosteron intake over choroidal parameters; such as choroidal thickness, choroidal vascularity index, choroidal stromal ve luminal areas,ect.

Detailed description: In the study, we have two group: First group consists of patients with testosteron deficiency and there are sex and age-matched healthy control subjects in the second group. We will measure the parameters of both groups at baseline. And first month and 3rd month we will remeasure the values of the parameters by enhance depth optical coherence tomography. The results will be compared between the groups.

Eligibility criteria: Inclusion Criteria:

for androgen deficient group: no other ocular and systemic disease except androgen deficiency. no history of ocular surgery or disease no medicine use for healthy controls :no other ocular and systemic disease. no history of ocular surgery or disease no medicine use, no smoking or any tobocco use

Exclusion Criteria:having any ocular and systemic disease. history of ocular surgery or disease,medicine use, smoking or any tobocco use

-

Primary outcomes:
measure: to evaluate Effects of External Testosteron Intake on the Choroid: Enhance-depth Imaging Optical Coherence Tomography Study
timeFrame: 2019 and 20120
Secondary outcomes:
Other outcomes:
Locations:
city: Samsun
country: Turkey
facility: Volkan YETER
Study officials:
References:
Clinical trial NCT03052647: Comparison of Adhesive Latch Device to Subcuticular Skin Closure at the Time of Cesarean Section
Official title: Comparison of Adhesive Latch Device to Subcuticular Skin Closure at the Time of Cesarean Section
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Wound
Keywords: dermaclip
subcuticular
cesarean section
staples
adhesive latch
rousseau
Lead sponsor: Rubino Ob-Gyn Group
Sponsor class: OTHER
First posted: 2017-02-14
Enrollment: 32
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A control group of subcuticular closure and the experimental group is skin closure withthe adhesive latch device ("dermaclip")
Primary purpose: TREATMENT

Brief summary: The objective of this study was to compare the an adhesive latch device (" Dermaclip") to subcuticular skin closure at the time of cesarean section. Currently, no studies exist comparing these two closure techniques. The hypothesis is dermaclip closure is faster than subcuticular closure. The null hypothesis is there is no difference in closure times. There is a study (see reference at bottom) that compares staples closure to subcuticular closure, but none comparing subcuticular to dermaclip closure. Dermaclip device is easily deployed and is expected to be as fast as staples closure compared to subcuticular as noted in the prior study referenced below.


Eligibility criteria: Inclusion Criteria:

1. Age greater than 18
2. Elective cesarean section
3. Term pregnancy

Exclusion Criteria:

1. Fever \>101F in the past 14 days
2. Antibiotics in the past 14 days
3. Suspected ongoing infection
4. Poorly controlled gestational diabetes
5. Allergic to adhesive

Primary outcomes:
measure: Comparison of adhesive latch device to subcuticular skin closure at the time of cesarean section
timeFrame: 18 months
Secondary outcomes:
measure: Pain Scores
timeFrame: 18 months
measure: Wound Infections as measured in centimeters of erythema
timeFrame: 18 months
measure: Wound separation as measured in centimeters
timeFrame: 18 months
measure: Patient Satisfaction scores
timeFrame: 18 months
measure: Total surgery time
timeFrame: 18 months
measure: Age
timeFrame: 18 months
measure: BMI
timeFrame: 18 months
measure: Ethnicity
timeFrame: 18 months
measure: Race
timeFrame: 18 months
Other outcomes:
Locations:
city: West Orange
country: United States
facility: Rubino OBGYN Group
state: New Jersey
Study officials:
References:
Clinical trial NCT03810547: Abdominoplasty Under Spinal Anesthesia
Official title: A Comparative Study Between Spinal and General Anesthesia for Abdominoplasty.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Spinal Anesthesia Suitability for Abdominoplasty
Keywords: Abdominoplasty
spinal anesthesia
general anesthesia
postoperative pain
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2019-01-18
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 100 patients undergoing abdominoplasty under spinal anesthesia. 100 patients undergoing abdominoplasty under general anesthesia

Detailed description: 200 patients, American Society of Anesthesiologists (ASA) physical status classes I and II, were enrolled in this feasible study. All patients were subjected to abdominoplasty operation under spinal anesthesia or general anesthesia. Any intraoperative complications like hypotension, bradycardia, pain, nausea and vomiting related to spinal anesthesia were managed and recorded. Postoperative visual analogue scale (VAS) was used to assess pain severity and the need for analgesia to be administered.

Eligibility criteria: Inclusion Criteria:

* All patients between 18-55 years
* ASA I and II

Exclusion Criteria:

* BMI more than 35 years
* Contraindications for regional anesthesia

Primary outcomes:
measure: Change in Pain sensation: Visual analogue scale
timeFrame: pain assessment during the operation and every 4 hours for 12 hours
measure: Patients satisfaction: Satisfaction score changes
timeFrame: Intraoperative assessment every 30 minutes till end of surgery.
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ain Shams University
Study officials:
References:
Clinical trial NCT06522347: Mycobacteria Registry Study: Prospective Observational Study in Austria
Official title: Mycobacteria Registry Study: Prospective Observational Study in Austria
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Non-Tuberculous Mycobacterial Pneumonia
Tuberculosis
Keywords: Mycobacterium tuberculosis
Nontuberculous Mycobacteria
Mycobacterium Infections
Lead sponsor: Ludwig Boltzmann Institute for Lung Health
Sponsor class: OTHER
Collaborators: name: Sigmund Freud PrivatUniversitat
First posted: 2024-07-26
Enrollment: 1000
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: Any patient presenting to outpatient clinic or ward of Klink Penzing or Klinik Hietzing due to Mycobacteria infection.

Brief summary: The goal of this non-interventional registry study is to systematically collect epidemiological and clinical data throughout the treatment course to learn about effectiveness of treatments. We will document the natural course of therapy without additional interventions. The main question to answer is:

What are the risk factors for mortality due to infection with Mycobacteria tuberculosis (TB) or Nontuberculous mycobacteria (NTM) in Austria?

Data from participants already receiving treatment as part of their regular medical care for TB or NTM infections will be collected.


Eligibility criteria: Inclusion Criteria:

* patients diagnosed with Mycobacterium tuberculosis or non-tuberculous mycobacteria infection
* individuals aged 18 years or older
* written informed consent

Exclusion Criteria:

* to not comprehend and rightfully judge participation

Primary outcomes:
measure: Mortality
timeFrame: 30 years
Secondary outcomes:
measure: Prevalence
timeFrame: 30 years
measure: Patient cohort
timeFrame: 30 years
measure: Risk factors
timeFrame: 30 years
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Klinik Hietzing
city: Vienna
country: Austria
facility: Klinik Penzing
city: Vienna
country: Austria
facility: Ludwig Boltzmann Institut for Lung Health
Study officials:
References:
Clinical trial NCT03451747: The Potential Role of Testosterone on Target Organ Damage in Postmenopausal Hypertensive Women
Official title: The Potential Role of Testosterone Between Hypertension and Target Organ Damage in Postmenopausal Hypertensive Women
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Hypertension
Keywords: hypertension
female
Lead sponsor: LanZhou University
Sponsor class: OTHER
First posted: 2018-03-02
Enrollment: 322
Sex: ALL
Minimum age (years): 45
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: A total of 322 hypertensive patients hospitalized in our department from 2016 to 2017 were enrolled. Included 161 postmenopausal hypertensive women and 161 mached hypertensive men.

Brief summary: The incidence of CVD-related deaths is generally higher in women than men. Postmenopausal changes in estrogen/androgen ratio that induce a relative androgen excess have been proposed as important factors in the higher prevalence of hypertension. Therefore, the investigators hypothesize that testosterone has potential role between hypertension and target organ damage in postmenopausal hypertensive women. And the objective is to evaluate the effects of testosterone between hypertension and target organ damage in postmenopausal hypertensive women.


Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of hypertension
* Women are all postmenopausal
* Men are matched with women.

Exclusion Criteria:

* Secondary hypertension
* Coronary disease
* Heart failure
* Arterial fibrillation
* Previous myocardial infarction
* Previous stroke
* Malignant disease
* Kidney failure
* Liver failure
* Neoplastic disease
* Severe neurological diseases
* Severe metabolic or organic decompensation
* Refuse to sign the informed consent form

Primary outcomes:
measure: Relative indexes of myocardial remodeling
timeFrame: Baseline
measure: Ambulatory blood pressure monitoring
timeFrame: Baseline
measure: The level of testosterone (T)
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Li N, Ma R, Wang S, Zhao Y, Wang P, Yang Z, Jin L, Zhang P, Ding H, Bai F, Yu J. The potential role of testosterone in hypertension and target organ damage in hypertensive postmenopausal women. Clin Interv Aging. 2019 Apr 29;14:743-752. doi: 10.2147/CIA.S195498. eCollection 2019.
Clinical trial NCT01647347: PVP Iodine Effect on Post Debridement Bacteraemia
Official title: Effects of Ultrasonic Debridement With PVP-iodine Irrigation on Post-treatment Bacteraemia Compared to Ultrasonic Debridement With Water
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Bacteraemia Post Debridement
Keywords: bacteria
bacteremia
PVP-iodine
periodontitis
Lead sponsor: University of Zurich
Sponsor class: OTHER
First posted: 2012-07-23
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: The study investigates the effect of supra- and subgingival rinsing of 10% PVP prior to ultrasonic debridement in patients with periodontitis (as compared to rinsing with water) in terms of post treatment bacteraemia.

Study design: Randomized split-mouth (cross-over) study on 20 generally healthy subjects.

Detailed description: Process:

Test treatment:

* 1 min mouthwash with 10% PVP-iodine
* 1 min subgingival rinsing with 10% PVP-iodine
* 1 min ultrasonic debridement with 10% PVP-iodine as cooling liquid
* blood sampling from the V.mediana cupidi

Control:

* 1 min mouthwash with water
* 1 min subgingival rinsing with water
* 1 min ultrasonic debridement with water as cooling liquid
* blood sampling from the V.mediana cupidi

lysis, culturing and analysis of bacteria in the samples

Eligibility criteria: Inclusion Criteria:

* generally healthy, adult (≥ 18 years) patients with at least two periodontal pockets of ≥ 5 mm

Exclusion Criteria:

* Pregnancy
* Lactation
* Allergy on PVP-iodine
* anticoagulation (exception 100mg/d acetylsalicylic acid)
* high risc for endocarditis
* therapeutical radiation
* participation in other clinical studies
* cognitive impairment (patient unable to understand aim and conduction of the study

Primary outcomes:
measure: quantity of bacteraemia in central blood stream
timeFrame: three minutes after starting debridement
measure: quality of bacteraemia in central blood stream
timeFrame: three minutes after starting debridement
Secondary outcomes:
Other outcomes:
Locations:
city: Zurich
country: Switzerland
facility: Clinic for Preventive Dentistry, Perioodntology and Cariology, University of Zurich
state: ZH
Study officials:
affiliation: Clinic for Preventive Dentistry, Periodontology and Cariology, University of Zurich
name: Philipp Sahrmann, Senior Assistant
role: PRINCIPAL_INVESTIGATOR
References: