louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT07001579: Cross-sectional Study of the Prevalence and Risk Factors of Asymptomatic Bacteriuria in Pregnancy
Official title: Prevalence and Associated Risk Factors of Asymptomatic Bacteriuria in Pregnancy at a Tertiary Care Hospital: a Cross-sectional Duty
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Urinary Tract Infection (Diagnosis)
Pregnancy
Lead sponsor: Nepalese Army Institute of Health Sciences
Sponsor class: OTHER
First posted: 2025-06-03
Enrollment: 390
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pregnant women visiting the Department of Obstetrics and Gynecology OPD, (Shree Birendra Hospital) located in Kathmandu for Antenatal Check-up.

Brief summary: Asymptomatic bacteriuria (ASB) is the presence of bacteria in the urine without symptoms of urinary tract infection. It is common during pregnancy and, if left untreated, may lead to complications such as pyelonephritis, preterm labor, and low birth weight. This cross-sectional study aims to determine the prevalence and identify associated risk factors of ASB among pregnant women attending antenatal care at a tertiary care hospital. Pregnant women meeting the inclusion criteria will be enrolled and evaluated through urine analysis and relevant history-taking. The findings may help guide future screening and treatment policies in antenatal care settings


Eligibility criteria: Inclusion Criteria:

* Pregnant women attending her regular ANC check-ups at the hospital.
* Who give consent to participate in the study.

Exclusion Criteria:

* Individuals not willing to participate
* Pregnant women showing signs and symptoms of UTI.
* Pregnant women on antibiotics or had been on antibiotics at least two weeks prior to presentation.
* Pregnant women with known underlying renal pathology.
* Pregnant women who are using immune-suppressants.

Primary outcomes:
measure: Prevalence of Asymptomatic Bacteriuria in Pregnant Women
timeFrame: Data was collected for 6 months after approval from IRC from April 2022 to September 2022 during each participant's first antenatal care (ANC) visit irrespective of the gestational age, using simple convenient sampling method.
Secondary outcomes:
Other outcomes:
Locations:
city: Kathmandu
country: Nepal
facility: Shree Birendra Hospita
state: Bagmati
Study officials:
References:
Clinical trial NCT00310479: Clinico-pathologic Correlative Study of 3T Magnetic Resonance Spectroscopy in the Localization of Prostate Cancer
Official title: Clinico-pathologic Correlative Study of 3T Magnetic Resonance Spectroscopy in the Localization of Prostate Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prostate Cancer
Keywords: Magnetic Resonance Imaging
prostate cancer imaging
3T MRS
functional imaging
Lead sponsor: AHS Cancer Control Alberta
Sponsor class: OTHER
Collaborators: name: Cross Cancer Institute
First posted: 2006-04-04
Enrollment: 16
Sex: MALE
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: We seek to develop an advanced imaging approach to identifying and localizing prostate cancer. We believe that high field MRI (magnetic resonance imaging) has the potential to do this and we will endeavor to prove this by having patients with prostate cancer pre-operatively undergo a technique called magnetic resonance spectroscopy. After surgery, the microscopic locations of cancer will be compared with the pre-operative images to assess how well the imaging technique succeeds.

Detailed description: The proposed research is enormously relevant to the clinical understanding of early prostate cancer. We propose to test to see whether characteristic patterns of invivo 3T MRSI associated metabolites can be identified in correlation with clinically active tumor reserved on histopathologic analysis of resected specimens. We also plan to demonstrate that 3T MR spectra of prostate cancer will allow for more detailed metabolic assessment with higher sensitivity, specificity and accuracy and publish results established from MR spectra using 1.5T MR units. Functional imaging (eg. molecular imaging such as this) is felt to be the clinical wave of the future for cancer imaging, and if successful, will assume a very major role in the detection, assessment, treatment planning and delivery of drugs, radiation, heat and novel therapeutics in the fight against prostate cancer.

Eligibility criteria: Inclusion Criteria:

* Histologically verified prostate cancer
* Patient has opted for surgery
* Low risk prostate cancer PSA \<1 0, Gleason \< 7, Stage \< T2b
* No contraindication to MR scanning
* No prior history of malignancy
* Fit for surgery

Exclusion Criteria:

* Nonbiopsied lesion
* Intermediate or high risk prostate cancer
* Unfit for surgery
* Contraindication to MR scanning (i.e. pacemaker, aneurysm clips, claustrophobia)

Primary outcomes:
measure: characteristic metabolic pattern of prostate cancer at 3Tesla
Secondary outcomes:
measure: specificity, accuracy, NPV
measure: PPV of MRS in the detection of prostate cancer
Other outcomes:
Locations:
city: Edmonton
country: Canada
facility: Cross Cancer Institute
state: Alberta
Study officials:
affiliation: AHS Cancer Control Alberta
name: Matthew Parliament, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03044379: Dapivirine Gel Rectal Safety and PK Study
Official title: A Randomized, Double Blind, Placebo-Controlled, Phase 1 Safety and Pharmacokinetic Study of Dapivirine Gel (0.05%) Administered Rectally to HIV-1 Seronegative Adults
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
Conditions: HIV 1 Infection
Lead sponsor: International Partnership for Microbicides, Inc.
Sponsor class: INDUSTRY
First posted: 2017-02-07
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Dapivirine Gel Rectal Safety and PK Study

Detailed description: A Randomized, Double Blind, Placebo-Controlled Phase 1 Safety and Pharmacokinetic Study of Dapivirine Gel (0.05%) Administered Rectally to HIV-1 Seronegative Adults

Eligibility criteria: Inclusion Criteria:

* Age of 18 - 45 years (inclusive), verified per site SOP
* Able and willing to provide written informed consent
* HIV-1/2 uninfected at Screening and Enrollment, per applicable algorithm in Appendix II and willing to receive HIV test results
* Able and willing to provide adequate locator information, as defined in site SOP
* Available to return for all study visits and willing to comply with study participation requirements
* In general good health at Screening and Enrollment, as determined by the site IoR or designee
* Per participant report, a history of consensual RAI at least once in the past calendar year
* Willing to not take part in other research studies involving drugs, medical devices, genital products, or vaccines for the duration of study participation, including the time between Screening and Enrollment

Exclusion Criteria: At Screening:

* Hemoglobin Grade 1 or higher\*
* Platelet count Grade 1 or higher\*
* White blood count Grade 2 or higher\*
* Serum creatinine 1.3 the site laboratory upper limit of normal (ULN)
* International normalized ratio (INR) 1.5 the site laboratory ULN
* Aspartate aminotransferase (AST) or alanine transaminase (ALT) Grade 1 or higher\*
* Positive for hepatitis C antibody
* Positive for hepatitis B surface antigen
* History of inflammatory bowel disease by participant report

Primary outcomes:
measure: Safety To characterize the systemic and compartmental pharmacokinetics of dapivirine gel following rectal application.
timeFrame: 9-12 months
Secondary outcomes:
measure: Acceptability
timeFrame: 9-12 months
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center
state: Pennsylvania
Study officials:
References:
Clinical trial NCT05080179: Impact of Nudges on Downloads of COVID-19 Exposure Notification Smartphone Apps: A Randomized Trial
Official title: The Interactive Effect of Social Norm and Self (vs. Others) Benefit Nudges on Downloads of COVID-19 Exposure Notification Smartphone Apps: A Randomized Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: COVID-19
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
Collaborators: name: Pennsylvania Department of Health
First posted: 2021-10-15
Enrollment: 16903
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: This is a 2 (Self-Benefit vs. Other-Benefit) x 2 (Social Norm vs. No Social Norm) design. There are thus four conditions total.
Primary purpose: TREATMENT

Brief summary: Eligible participants who were active beneficiaries of a large insurer living in Pennsylvania were sent an email encouraging them to download the contact tracing app in Pennsylvania, COVID Alert PA.

Participants will be randomly assigned to one of four conditions in a 2 (Self-benefit vs. Other-Benefit) x 2 (Social Norms Present vs. Social Norms absent) design.

All participants received an email that said :

"COVID Alert PA is the official Exposure Notification App from the Pennsylvania Department of Health. Join Penn Medicine in the fight against COVID-19 and download COVID Alert PA today!"

---Investigators manipulated the content here---

"The app uses Bluetooth to sense when one person is in close contact with another person with the app. If someone tests positive for COVID-19, and they decide to upload the information to the health department, people who have the app and who have been in contact with them will be alerted.

If you are interested in downloading the app, please click COVID Alert PA. We appreciate you joining our efforts. Together we can beat COVID-19!"

In the Other-Benefit condition, it said: "It can help you reduce your risk of unknowingly spreading the virus to your friends, family, and larger community."

In the Self-Benefit condition, it said: "It can help you determine where and when to get testing, and how to get care if you need it."

In the Social Norms Present condition, it said: "Over 650,000 Pennsylvanians have already downloaded the app!"

In the Social Norms Absent condition, it said the statement about social norms above.

Participants who do not open the initial email received a follow-up email.


Eligibility criteria: Inclusion Criteria:

* Eligible participants were active beneficiaries of a large insurer living in Pennsylvania.

Exclusion Criteria:

* Participants who did not subscribe to offers and promotions emails were excluded, as were Medigap beneficiaries.

Primary outcomes:
measure: Click on Link to Download COVID Alert PA App
timeFrame: 48 days
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Independence Blue Cross (IBX)
state: Pennsylvania
Study officials:
References:
Clinical trial NCT05774379: Virtual Reality and Fatigue Education
Official title: The Effect of Virtual Reality and Fatigue Education on Fatigue and Anxiety Levels in Children With Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fatigue
Anxiety
Keywords: virtual reality
Lead sponsor: Dokuz Eylul University
Sponsor class: OTHER
First posted: 2023-03-17
Enrollment: 41
Sex: ALL
Minimum age (years): 7
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: It was planned to evaluate the effect of distraction intervention with virtual reality and fatigue education on the level of fatigue and anxiety in children with cancer.

Detailed description: H1: The fatigue scores of the patients who received distraction intervention with virtual reality and were given fatigue training were lower than the group that was given only fatigue training.

H2: The anxiety scores of the patients who received distraction intervention with virtual reality and were given fatigue training were lower than the group that was given only fatigue training.

Data collection After the child and his family are informed about the study, their written informed consent will be obtained. All children included in the study on the day (day 0) prior to the start of chemotherapy treatment will be given training on fatigue. In order to determine how he felt and his level of fatigue on the day of the training, it was planned to apply the Child Anxiety Scale-State (CAS-D), Child Fatigue Scale-24 Hours and Visual Fatigue Scale at 16.00 (pretest).

After randomization is achieved, a distraction intervention will be applied once a day for 10-15 minutes with virtual glasses on the 1st, 2nd and 3rd days of the chemotherapy treatment of the children in the study group. This intervention is planned to take place between 14.00-15.00 in the afternoon.

Eligibility criteria: Inclusion Criteria:

* Be between 7-18 years old
* Inpatient chemotherapy treatment for more than three days
* 4 weeks over the time of diagnosis (not in the induction phase)
* Having a hemoglobin level above the criteria for transfusion of blood products (8 mg/dl for hematological malignancies, below 7 mg/dl for oncological malignancies).
* The child voluntarily agrees to participate in the study and consent is obtained from the child and parent

Exclusion Criteria:

* Being in terminal period
* undergoing a surgical operation
* Unwillingness to participate in the study

Primary outcomes:
measure: fatigue
timeFrame: pretest, 1., 2. and 3. days of chemotheraphy
measure: anxiety
timeFrame: pretest, 1., 2. and 3. days of chemotheraphy
Secondary outcomes:
Other outcomes:
Locations:
city: İzmir
country: Turkey
facility: Gülçin Özalp Gerçeker
Study officials:
affiliation: Dokuz Eylul University
name: Gülçin Özalp Gerçeker, pHD, RN
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00839579: Cardiovascular Treatment
Official title: How Little Pain for Cardiac Gain? A Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Keywords: slightly overweight
males 35-45 years
Lead sponsor: Norwegian University of Science and Technology
Sponsor class: OTHER
First posted: 2009-02-09
Enrollment: 26
Sex: MALE
Minimum age (years): 35
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Exercise training is proved to protect against premature cardiovascular mortality. Additionally there is evidence that relatively high exercise intensity may be an important factor for improving aerobic capacity and endothelial function in patients with post-infarction heart failure, metabolic syndrome, coronary artery disease, as well as in overweight and obese individuals.

The aim of this study is to investigate the amount of high-intensity exercise needed to improve aerobic capacity and endothelial function.


Eligibility criteria: Inclusion Criteria:

* BMI: 25-30
* Males, 35-45 years
* Healthy

Primary outcomes:
measure: Maximal oxygen consumption and endothelial function
timeFrame: baseline and 12 weeks followup
Secondary outcomes:
Other outcomes:
Locations:
city: Trondheim
country: Norway
facility: Norwegian University of Science and Technology
Study officials:
affiliation: Norwegian University of Science and Technology
name: Arnt E Tjønna, PhD
role: STUDY_CHAIR
affiliation: Norwegian University of Science and Technology
name: Ulrik Wisløff, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Tjonna AE, Leinan IM, Bartnes AT, Jenssen BM, Gibala MJ, Winett RA, Wisloff U. Low- and high-volume of intensive endurance training significantly improves maximal oxygen uptake after 10-weeks of training in healthy men. PLoS One. 2013 May 29;8(5):e65382. doi: 10.1371/journal.pone.0065382. Print 2013.
Clinical trial NCT00556179: Lactoserum (Dermacyd Femina®) and Prevention of Recurrence of Bacterial Vaginosis
Official title: Local, National (Brazil), Multicentric, Open, Non-Controlled, Phase IV, Study of Lactoserum (Dermacyd Femina®), in Women at Reproductive Age, to Prevent Recurrence of Bacterial Vaginosis, During Three Months, After Standard Treatment With Metronidazole.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Bacterial Vaginosis
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2007-11-09
Enrollment: 122
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to demonstrate if the use of Dermacyd can avoid the recurrence of bacterial vaginosis after three months of the standard treatment.


Eligibility criteria: Inclusion Criteria:

* Women in reproductive age
* Confirmed cure of bacterial vaginosis after treatment with oral metronidazole.
* Vaginal bacterioscopic examination negative for candida and trichomonas.

Exclusion Criteria:

* Pregnant or breastfeeding women
* Allergy to dermacyd

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Primary outcomes:
measure: Rate of recurrence of bacterial vaginosis after three months of treatment.
timeFrame: Three months
Secondary outcomes:
measure: Quality of life
timeFrame: Three months
measure: Vaginal Candidiasis
timeFrame: Three months
measure: AE, particularly genital irritation (tolerability use of dermacyd)
timeFrame: During the study
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Sanofi-aventis
Study officials:
affiliation: Sanofi-aventis administrative office Brazil
name: Jaderson Lima
role: STUDY_DIRECTOR
References:
Clinical trial NCT05034679: Impact of Corona Vaccination on AMH- Anti Mullerian Hormone
Official title: Wether Corona Vaccination Has Negative Impact on AMH- Anti Mullerian Hormone Which Express Ovarin Function
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Patient Participation
Lead sponsor: Wolfson Medical Center
Sponsor class: OTHER_GOV
First posted: 2021-09-05
Enrollment: 90
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 44
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Women who are going through IVF treatments.

Brief summary: Since December 2020 Nationwide anti-COVID-19 vaccination began in Israel using the Pfizer - BioNtech vaccine (BNT162b2 mRNA). The vaccination campaign has been associated with concerns regarding potential detrimental effects on future fertility. The aim of the study is to determine the impact of COVID-19 vaccination on n AMH- Anti Mullerian Hormone which express ovarin function.

disease and/or immunization on human follicular function, by comparing follicular steroidogenesis, response to the LH/hCG trigger, and oocyte quality biomarker (HSPG2), in the aspirated follicular fluid of patients undergoing ovum pick-up.

Detailed description: Our assumption is that there is no effect of the vaccination on the AMH level. We plan to recruit 90 patients who are divided to three groups First group patients who vaccinated and measure the AMH before and up to 9 months after vaccination. Second group patients who were infected by Covid-19 ant therefor were not vaccinated to compare the AMH level before and after the infectious. The third group patients who were not infected and not vaccinated.

Eligibility criteria: Inclusion Criteria:

* Age 18-44

Exclusion Criteria:

Age over 45

Primary outcomes:
measure: Amh levels
timeFrame: 9 months
Secondary outcomes:
Other outcomes:
Locations:
city: Holon
country: Israel
facility: Wolfson medical center
Study officials:
References:
Clinical trial NCT03063879: Treating Hepatitis C in CRF Using Sofosbuvir and Daclatasvir
Official title: Efficacy and Safety of Sofosbuvir and Daclatasvir in Treating Patients With Hepatitis C and Renal Failure.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hepatitis C, Chronic
Chronic Renal Failure
Keywords: hepatitis C
renal failure
sofosbuvir
daclatasvir
Lead sponsor: Tehran University of Medical Sciences
Sponsor class: OTHER
Collaborators: name: Ahvaz Jundishapur University of Medical Sciences
name: Shiraz University of Medical Sciences
name: Hamadan University of Medical Science
First posted: 2017-02-24
Enrollment: 95
Sex: ALL
Minimum age (years): 16
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Sofosbuvir is the base of most treatment regimens for hepatitis C. In patients with renal failure the blood level of one of its metabolites (GS-331007) rises up to 20 folds. Although no particular adverse event has been linked to this metabolite sofosbuvir is not recommended for patients with renal failure mainly because of lack of data. Nevertheless there are anecdotal reports and small studies proving the safety of sofosbuvir in renal failure. This study addresses this lack of information by evaluating the safety and efficacy of sofosbuvir and daclatasvir in treating hepatitis C in 100 patients with renal failure.


Eligibility criteria: Inclusion Criteria:

* Positive qualitative hepatitis C virus RNA test on two occasions at least 6 months apart
* Renal failure (eGFR \< 30 cc/min) or under hemodialysis

Exclusion Criteria:

* Model for End-stage Liver Disease (MELD) score \> 20,
* Child's C (CTP score \> 12),
* Heart rate \< 50/min,
* Taking amiodarone

Primary outcomes:
measure: Sustained Viral Response (SVR12)
timeFrame: 12 weeks after end of treatment
Secondary outcomes:
measure: Safety as assessed by adverse drug events
timeFrame: From start of treatment to 12 weeks after end of treatment
Other outcomes:
Locations:
city: Tehran
country: Iran, Islamic Republic of
facility: Shariati Hospital
Study officials:
affiliation: Tehran University of Medical Sciences
name: Shahin Merat, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Poustchi H, Majd Jabbari S, Merat S, Sharifi AH, Shayesteh AA, Shayesteh E, Minakari M, Fattahi MR, Moini M, Roozbeh F, Mansour-Ghanaei F, Afshar B, Mokhtare M, Amiriani T, Sofian M, Somi MH, Agah S, Maleki I, Latifnia M, Fattahi Abdizadeh M, Hormati A, Khoshnia M, Sohrabi M, Malekzadeh Z, Merat D, Malekzadeh R. The combination of sofosbuvir and daclatasvir is effective and safe in treating patients with hepatitis C and severe renal impairment. J Gastroenterol Hepatol. 2020 Sep;35(9):1590-1594. doi: 10.1111/jgh.14994. Epub 2020 Feb 5.