louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05916105: Ciprofloxacin Utilization and Adverse Events Occurrence in Community Pharmacy Setting
Official title: Drug Utilization Evaluation Study of Ciprofloxacin Utilization and Adverse Events Occurrence in Community Pharmacy Setting: A Cross-Sectional Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ciprofloxacin Adverse Reaction
Keywords: Ciprofloxacin
Use evaluation
Drug interaction
Lead sponsor: Damanhour University
Sponsor class: OTHER
First posted: 2023-06-23
Enrollment: 151
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: A total of 151 patients' record indicated for ciprofloxacin were included in the study.

Brief summary: Background: Ciprofloxacin is a fluoroquinolone that is commonly used to treat a variety of diseases. Ciprofloxacin resistance is rising, resulting in suboptimal patient care. The goal of this study was to evaluate ciprofloxacin use in the community in terms of acceptable prescription, dose, frequency, and duration of use.

Methods: A cross-sectional research was done in Egyptian community pharmacies by community pharmacists. Patients who were administered oral ciprofloxacin during the research period were included.

Detailed description: From September 2021 to February 2022, a cross-sectional, research was undertaken to evaluate ciprofloxacin usage. The investigation was carried out by community pharmacists in seven Egyptian community pharmacies.

Data Collection: data gathered from pharmacy patients' records on a data collection form that included the factors indicated. The General Symptoms Questionnaire, physical examination, and blood testing were used to identify adverse occurrences.

Study variables:

* age, gender, pregnancy/lactation
* Department/indication
* Dose, Frequency, Duration, Adverse events, Drug interactions.

Data was categorized and analyzed using appropriate software.

Eligibility criteria: Inclusion Criteria:

* All ciprofloxacin included prescription during the study period.

Exclusion Criteria:

* un included ciprofloxacin prescription.

Primary outcomes:
measure: Indications
timeFrame: 6 months
measure: ciprofloxacin prescription (frequency )
timeFrame: 6 months
measure: adverse events
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Damanhūr
country: Egypt
facility: Rehab Hussein Werida
state: Elbehairah
Study officials:
affiliation: Damanhour University
name: Rehab H Werida, Ass. Prof.
role: STUDY_DIRECTOR
References:
citation: Goldman MP. Ciprofloxacin drug utilization review and prospective drug use evaluation. DICP. 1990 Jan;24(1):82-6. doi: 10.1177/106002809002400115.
citation: Davis R, Markham A, Balfour JA. Ciprofloxacin. An updated review of its pharmacology, therapeutic efficacy and tolerability. Drugs. 1996 Jun;51(6):1019-74. doi: 10.2165/00003495-199651060-00010.
Clinical trial NCT04817605: Effects of Therapeutic Exercise in Patients With Fibromyalgia
Official title: Effects of Therapeutic Exercise in Patients With Fibromyalgia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Therapeutic Exercise
Chronic Pain
Lead sponsor: Universidad de Zaragoza
Sponsor class: OTHER
First posted: 2021-03-26
Enrollment: 30
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Fibromyalgia syndrome is characterized by chronic generalized musculoskeletal pain associated with fatigue, sleep disturbances and some biochemical markers. The European League Againts Rheumatism (EULAR) described an algorithm how to treat step by step these patients.

The objective of this trial is to evaluate if therapeutic exercise is effective on fatigue, pain threshold, quality of life, quality of sleep, pain coping and biochemical and genetic markers.

For this purpose, the investigators conduct a randomized controlled trial double-blind (patient and examiner). The investigators included patients diagnosed of fibromyalgia according to the American College of Rheumatology (ACR).

Patients included one group receiving exercise therapy consisting of 3 treatment sessions a week over 10 weeks.

The variables are measured at the beginning and end of treatment.


Eligibility criteria: Inclusion Criteria:

* Diagnosed medically with Fibromyalgia
* Diagnosed according to the American College of Rheumatology criteria
* Agreement to attend to treatment sessions

Exclusion Criteria:

* Any kind of contraindications for physical activity
* Other kind of diseases that could limit the intervention
* Previous surgery last year
* Medication modifications in the last 3 months

Primary outcomes:
measure: Pain intensity
timeFrame: Baseline
measure: Pain intensity
timeFrame: through study completion, an average 10 weeks
measure: Quality of Sleep
timeFrame: Baseline
measure: Quality of Sleep
timeFrame: through study completion, an average 10 weeks
Secondary outcomes:
measure: Pressure pain threshold
timeFrame: Baseline
measure: Pressure pain threshold
timeFrame: through study completion, an average 10 weeks
measure: Central sensitization
timeFrame: Baseline
measure: Central sensitization
timeFrame: through study completion, an average 10 weeks
measure: Analysis of tryptophan metabolites
timeFrame: Baseline
measure: Analysis of tryptophan metabolites
timeFrame: through study completion, an average 10 weeks
Other outcomes:
Locations:
city: Soria
country: Spain
facility: Sandra Jiménez Jiménez-del-Barrio
Study officials:
References:
Clinical trial NCT02738905: Impact of Rifaximin Therapy on Intestinal Byproducts in End-Stage Renal Disease
Official title: Impact of Rifaximin Therapy on Intestinal Byproducts in End-Stage Renal Disease
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: EARLY_PHASE1
Conditions: End Stage Renal Disease
Lead sponsor: University of Kansas Medical Center
Sponsor class: OTHER
Collaborators: name: American Heart Association
First posted: 2016-04-14
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine if rifaximin reduces serum trimethylamine-N-oxide (TMAO) levels in patients with end-stage renal disease.

Detailed description: Study participants will undergo 3 study visits: baseline, day 7 (immediately post-therapy), day 21 (2 weeks post-therapy). All participants will provide blood and stool samples at each visit.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of end-stage renal disease
* Receiving chronic intermittent hemodialysis

Exclusion Criteria:

* Patients with less advanced kidney disease
* Inability or unwillingness to provide informed consent
* Patients who may be pregnant
* Hemodynamically unstable patients
* Patients with liver failure, pancreatic insufficiency, or inflammatory bowel disease
* Patients with ongoing or recent infection and those with history of C-diff infection
* Patients with abnormal bowel structure secondary to surgical or anatomic variations
* Patients on certain medications, including immunosuppressants, antidiarrheal agents, or recent (within the last 2 months) use of antibiotics

Primary outcomes:
measure: Change in serum TMAO levels
timeFrame: Change from Baseline to Day 7
Secondary outcomes:
measure: Change in serum TMAO levels
timeFrame: Change from Baseline to Day 21
measure: Change in fecal bacterial species
timeFrame: Change from Baseline to Day 7
measure: Change in fecal bacterial colony numbers
timeFrame: Change from Baseline to Day 7
measure: Change in fecal bacterial species
timeFrame: Change from Baseline to Day 21
measure: Change in fecal bacterial colony numbers
timeFrame: Change from Baseline to Day 21
Other outcomes:
Locations:
city: Kansas City
country: United States
facility: University of Kansas Medical Center
state: Kansas
city: Westwood
country: United States
facility: Westwood Dialysis Center
state: Kansas
Study officials:
affiliation: University of Kansas Medical Center
name: Jason Stubbs, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04780698: DCI COVID-19 Surveillance Project
Official title: DCI COVID-19 Surveillance Project
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Covid19
Lead sponsor: Temple University
Sponsor class: OTHER
Collaborators: name: Dialysis Clinic, Inc.
First posted: 2021-03-03
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

Brief summary: This is a prospective longitudinal census study conducted at a single center (DCI Inc., Henry Avenue, Philadelphia). The purpose of this study is to gain information about COVID-19 infection and antibody response in an in-center dialysis population. The investigators hypothesize that screening and surveillance for COVID-19 positive test (viral infection) and antibodies response to infection (potential immunity) in a dialysis center population within a high-prevalence region can provide foundational information to guide approaches toward prevention of COVID-19 related illness in a susceptible population. Participants will be given a questionnaire initially and monthly over the study period to find out whether they have had COVID-19 infection, hospitalization, or symptoms. A nasopharyngeal swab test for COVID-19 infection and a blood sample for COVID-19 antibody will be collected monthly for the study period.


Eligibility criteria: Inclusion Criteria:

* Patients who receive in-center chronic dialysis (\>3 months) at DCI Henry Avenue
* Patients who are able to consent for study

Exclusion Criteria:

* Patients receiving transient hemodialysis at DCI or receiving hemodialysis for Acute Renal Failure
* Patients who are unable to consent
* Patients who are receiving other forms of dialysis therapy (e.g. home hemodialysis, peritoneal dialysis)
* Patients whose life expectancy is \<12 months
* Patients who are planning to leave the dialysis center within 12 months

Primary outcomes:
measure: Incidence of COVID-19 infection in the cohort
timeFrame: monthly through study completion (average of 18 months)
measure: Link the presence of COVID-19 infection to COVID-19 antibody formation (seroconversion) from qualitative testing
timeFrame: monthly through study completion (average of 18 months)
measure: Incidence of COVID-19 reinfection
timeFrame: monthly through study completion (average of 18 months)
measure: Presence of antibodies in cases of reinfection
timeFrame: monthly through study completion (average of 18 months)
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Dialysis Clinic, Inc.
state: Pennsylvania
Study officials:
affiliation: Temple University
name: Avrum Gillespie, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02844998: The Impact and Benefit of Physical Activity on Premature Ejaculation
Official title: The Impact and Benefit of Physical Activity on Premature Ejaculation: Results of a Prospective, Randomized, Placebo-controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Premature Ejaculation
Keywords: intravaginal ejaculatory latency time
international physical activity questionnaire
premature ejaculation diagnostic tool
Lead sponsor: Ankara Training and Research Hospital
Sponsor class: OTHER
First posted: 2016-07-26
Enrollment: 120
Sex: MALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to investigate the relationship between physical activity and PE, and determine whether moderate physical activity might delay ejaculation time or be an alternative treatment for PE.


Eligibility criteria: Inclusion Criteria:

* Sexually active, heterosexual patients without regular physical activity or erectile dysfunction, and had a sexual partner for at least six months, and sexual intercourse at least twice a week

Exclusion Criteria:

* Use of medications for endocrinological, metabolic, chronic systemic, or psychiatric diseases, use of alcohol or addictive substances, or use of drugs that might affect erection and ejaculation, presence of patients with Peyronie's disease, chronic prostatitis, urethritis, or active urinary tract infection, and absence of regular physical activity or previous treatment for premature ejaculation.

Primary outcomes:
measure: Premature Ejaculation Diagnostic Tool (Total Score)
timeFrame: Baseline and 30 Days
measure: Intravaginal Ejaculatory Latency Time
timeFrame: Baseline and 30 Days
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Craig CL, Marshall AL, Sjostrom M, Bauman AE, Booth ML, Ainsworth BE, Pratt M, Ekelund U, Yngve A, Sallis JF, Oja P. International physical activity questionnaire: 12-country reliability and validity. Med Sci Sports Exerc. 2003 Aug;35(8):1381-95. doi: 10.1249/01.MSS.0000078924.61453.FB.
citation: Symonds T, Perelman MA, Althof S, Giuliano F, Martin M, May K, Abraham L, Crossland A, Morris M. Development and validation of a premature ejaculation diagnostic tool. Eur Urol. 2007 Aug;52(2):565-73. doi: 10.1016/j.eururo.2007.01.028. Epub 2007 Jan 16.
citation: Sunay D, Sunay M, Aydogmus Y, Bagbanci S, Arslan H, Karabulut A, Emir L. Acupuncture versus paroxetine for the treatment of premature ejaculation: a randomized, placebo-controlled clinical trial. Eur Urol. 2011 May;59(5):765-71. doi: 10.1016/j.eururo.2011.01.019. Epub 2011 Jan 18.
Clinical trial NCT00403598: Preliminary Study for Identification of Calcium-Binding Proteins in the Serum in Various Metabolic Bone Disorders
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Osteoporosis
Osteitis Deformans
Parathyroid Diseases
Lead sponsor: Sheba Medical Center
Sponsor class: OTHER_GOV
Collaborators: name: Ben-Gurion University of the Negev
First posted: 2006-11-27
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: OTHER

Brief summary: The purpose of this study is to determine whether the serum levels of certain calcium-binding proteins may be helpful in the diagnosis and management of metabolic bone diseases.

Detailed description: Osteoporosis is an important and costly health issue. The diagnosis of the disease is based on measurement of bone mineral density or the occurrence of characteristic fractures. Currently it is not possible to predict fractures in individual patients, and the ability to monitor the response to treatment is limited as well.

We have synthesized and characterized a novel photoreactive Ca2+-analog reagent, Azido ruthenium (AzRu) that binds covalently to Ca2+-binding sites in proteins. The specificity of AzRu for Ca2+-binding proteins, its photoactivation and its radioactive labeling pave the way for a wide use of AzRu as a powerful tool to assess Ca2+-dependent cellular processes, both in vitro and in vivo. Using radiolabeled AzRu, it will be possible to identify Ca2+-binding proteins in a biological sample such as whole cell, isolated mitochondria, ER or other protein containing fractions. Protein bound \[103Ru\]AzRu in biological sample can be separated by SDS gel electrophoresis, followed by Coomassie staining and exposure of the dried gel to X-ray film (autoradiography). This allows the identification of the \[103Ru\] radiolabeled proteins. The labeled protein bands can be cut from the gel and subjected to MALADI-TOF analysis and the identity of the protein can be determined by a sequence homology search.

These would allow detection of Ca2+-binding proteins in the serum of various diseases and disorders, potentially leading to identification of novel biomarkers for disease diagnostics.

We would like to use blood samples to carry out the procedure described above for identification of Ca2+ binding proteins appearing or their level is increased in disease or under pathogenic conditions. Since Ca2+ binding proteins play an important role in bone metabolism, we chose to test their occurrence in the serum of patients with osteoporosis and other metabolic bone diseases.

Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of a metabolic bone disorder

Exclusion Criteria:

* none

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Ramat Gan
country: Israel
facility: Sheba Medical Center, Tel Hashomer
Study officials:
affiliation: Sheba Medical Center, Tel Hashomer
name: Iris Vered, M.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02601898: Vaginal Administration of ALA vs Progesterone for the Subchorionic Hematoma Treatment
Official title: Vaginal Administration of Alpha Lipoic Acid vs Progesterone for the Subchorionic Hematoma Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Subchorionic Hematoma in the First Trimester Pregnancy
Miscarriage
Lead sponsor: Azienda USL Ferrara
Sponsor class: OTHER_GOV
First posted: 2015-11-11
Enrollment: 54
Sex: FEMALE
Minimum age (years): 24
Maximum age (years): 37
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study was to compare the therapeutic efficacy of lipoic acid versus progesterone by vaginal administration on subchorionic hematoma resorption in women at the first trimester of pregnancy with threatened miscarriage.


Eligibility criteria: Inclusion Criteria:

* Age: 24-37
* Gestational week: 7- 12
* Evidence of threatened miscarriage (pelvic pain with or without vaginal bleeding)
* Ultrasound evidence of subchorionic hematoma

Exclusion Criteria:

* Lack of fetus
* Absence of fetal heart tone
* Uterine anomaly or fetal anomaly
* Presence of multiple pregnancy
* Gestation pathology
* Therapies with anti-coagulants or anti-hypertensive drugs

Primary outcomes:
measure: Change in subchorionic hematoma from baseline at 20 days and 40 days, assessed as %improvement/worsening by ultrasoud examination
timeFrame: T1 (20 days); T2 (40 days)
Secondary outcomes:
measure: Number of participants with abdominal pain as assessed by questionnaire
timeFrame: T1 (20 days)
measure: Number of participants with vaginal bleeding as assessed by questionnaire
timeFrame: T1 (20 days)
measure: Number of participants with abdominal pain as assessed by questionnaire
timeFrame: T2 (40 days)
measure: Number of participants with vaginal bleeding as assessed by questionnaire
timeFrame: T2 (40 days)
measure: Number of participants who miscarried as assessed by ultrosound examination
timeFrame: 20 weeks of gestation
Other outcomes:
Locations:
city: Ferrara
country: Italy
facility: Azienda USL Ferrara
Study officials:
References:
citation: Yassaee F, Shekarriz-Foumani R, Afsari S, Fallahian M. The effect of progesterone suppositories on threatened abortion: a randomized clinical trial. J Reprod Infertil. 2014 Jul;15(3):147-51.
citation: Porcaro G, Brillo E, Giardina I, Di Iorio R. Alpha Lipoic Acid (ALA) effects on subchorionic hematoma: preliminary clinical results. Eur Rev Med Pharmacol Sci. 2015 Sep;19(18):3426-32.
citation: Costantino M, Guaraldi C, Costantino D. Resolution of subchorionic hematoma and symptoms of threatened miscarriage using vaginal alpha lipoic acid or progesterone: clinical evidences. Eur Rev Med Pharmacol Sci. 2016 Apr;20(8):1656-63.
Clinical trial NCT05255198: Anterior Minimal Invasive Surgery Versus Antero-lateral Approach in Hip Joint Hemiarthroplasty
Official title: Anterior Minimal Invasive Surgery Versus Antero-lateral Approach in Hip Joint Hemiarthroplasty
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Arthroplasty
Clinical Outcome
Lead sponsor: Rehabilitation Hospital Tobelbad
Sponsor class: OTHER
First posted: 2022-02-24
Enrollment: 83
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 consecutive patients, presenting with indication for bipolar hemiarthroplasty of the hip joint due to Garden III and IV fractures, who had given their written informed consent, were enrolled in the study. Exclusion

Brief summary: Comparison between two minimally invasive approaches to the hip joint.

Detailed description: Following parameters were compared: modified Barthel-Index, pain, complications, developing of heterotopic ossification.

Eligibility criteria: Exclusion Criteria:

Exclusion criteria represented acute local or systemic infection, open or pathological fractures, concomitant injuries of the ipsi- or contralateral leg and rheumatoid arthritis.

Primary outcomes:
measure: Visual Analogue Scale
timeFrame: one year after surgery
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01455298: Liver Disease in Adults With Alpha-1 AT Deficiency
Official title: Research of Infra Clinical Liver Injuries in Adult Patients Presented With Alpha-1 AT Deficiency
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Alpha-1 AT Deficiency
Keywords: Alpha-1 AT deficiency
liver injury
Transient Elastography
FibroTest
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2011-10-19
Enrollment: 33
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

Brief summary: This cohort study will evaluate the prevalence of the infra clinical liver injuries among a group of adult patients presenting with Alpha-1 AT deficiency followed up in a large university hospital in Lyon, France.


Eligibility criteria: Inclusion Criteria:

* Patients over 18 years old
* Presenting an Alpha-1 AT deficiency (Alpha-1 AT level \<0.8g/l at the time of diagnosis)

Exclusion Criteria:

* Patients presenting a liver disease not related to the Alpha-1 AT deficiency

Primary outcomes:
measure: The prevalence of infra clinical liver injuries
timeFrame: At least one day depending on the schedule of the exams
Secondary outcomes:
measure: morphological liver complications description
timeFrame: At least one day depending on the schedule of the exams
measure: measure of biological parameters
timeFrame: At least one day depending on the schedule of the exams
Other outcomes:
Locations:
city: Bron
country: France
facility: Hôpital Femme Mère Enfant - Hospices Civils de Lyon
Study officials:
affiliation: Hospices Civils de Lyon
name: Jean-François MORNEX, PhD, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Guillaud O, Dumortier J, Traclet J, Restier L, Joly P, Chapuis-Cellier C, Lachaux A, Mornex JF. Assessment of liver fibrosis by transient elastography (Fibroscan(R)) in patients with A1AT deficiency. Clin Res Hepatol Gastroenterol. 2019 Feb;43(1):77-81. doi: 10.1016/j.clinre.2018.08.016. Epub 2019 Jan 3.