louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00273416: A Randomized Double Blind, Placebo Controlled Balanced 4-Way Crossover Study To Assess The Efficacy Of Single Oral Doses
Official title: A Randomized Double Blind, Placebo Controlled Balanced 4-Way Crossover Study To Assess The Efficacy Of Single Oral Doses Of PF-00592379 On Erectile Function, Using 100mg Sildenafil As A Positive Control
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Impotence
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2006-01-09
Enrollment: 32
Sex: MALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The primary aim of this study is to assess how effective PF-00592379 is in restoring penile erections in patients with erectile dysfunction. Patients will attend for 4 treatment visits where they will receive the following in random order; 2 separate doses of PF-00592379, sildenafil 100mg used as a positive control, or placebo (dummy medication). The effect on penile erections will be assessed in the clinic using penile plethysmography (RigiScan PlusTM technique).


Eligibility criteria: Inclusion Criteria:

* Erectile dysfunction, previous good response to an oral treatment for erectile dysfunction.

Exclusion Criteria:

* Patients with high blood pressure or certain heart conditions (e.g. angina, heart failure), regardless of whether treated or not.
* Patients on nitrates or alpha-blocker medications.

Primary outcomes:
measure: Duration of penile erections of greater than or equal to 60% rigidity as assessed by penile plethysmography (RigiScan PlusTM).
Secondary outcomes:
measure: Duration and quality of penile erections recorded in a self-assessment diary.
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Pfizer Investigational Site
city: Belfast
country: United Kingdom
facility: Pfizer Investigational Site
state: Northern Ireland
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT00915616: The Potential Therapeutic Effect of Melatonin in Gastro-Esophageal Reflux Disease
Official title: The Potential Therapeutic Effect of Melatonin in Gastro-Esophageal Reflux Disease
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE3
Conditions: Gastroesophageal Reflux Disease
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2009-06-08
Sex: ALL
Minimum age (years): 42
Maximum age (years): 56
Standard ages: ADULT
Accepts healthy volunteers: yes
Primary purpose: TREATMENT

Brief summary: Gastro-Esophageal Reflux Disease was defined as a condition that develops when the reflux of stomach contents causes troublesome symptoms and/or complications. Many drugs used for the treatment of GERD such as omeprazole (a proton pump inhibitor) which is widely used anti-ulcer drug and has been demonstrated to protect against esophageal mucosal injury. Melatonin has been found to protect the gastrointestinal mucosa from oxidative damage caused by reactive oxygen species in different experimental ulcer models. The aim of this study is to evaluate the role of exogenous melatonin in the treatment of reflux disease in human either alone and in combination with omeprazole therapy.


Eligibility criteria: Inclusion Criteria:

* patient with GERD ranged from 42 to 56 years

Exclusion Criteria:

* patients with cardiac disease
* patients with renal affection
* patients with liver diseases (due to drug induced, autoimmune disease and viral hepatitis)
* patients on the drugs known to affect the GIT motility (phenothiazines, anticholinergics, nitrates or calcium channel blockers) were excluded during the time of conduction of the study or the preceding two weeks

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Kandil TS, Mousa AA, El-Gendy AA, Abbas AM. The potential therapeutic effect of melatonin in Gastro-Esophageal Reflux Disease. BMC Gastroenterol. 2010 Jan 18;10:7. doi: 10.1186/1471-230X-10-7.
Clinical trial NCT06345716: Paracetamol-Tramadol and Paracetamol-caffeine Versus Placebo in the Emergency Discharge Treatment of Renal Colic
Official title: Paracetamol-Tramadol and Paracetamol-caffeine Versus Placebo in the Emergency Discharge Treatment of Renal Colic
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Renal Colic
Keywords: renal colic
paracetamol-tramadol
paracetamol-cafeine
placebo
Lead sponsor: University of Monastir
Sponsor class: OTHER
First posted: 2024-04-03
Enrollment: 1500
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a prospective, randomized, single-blind study. Patients included in the study after successful treatment of the acute attack were randomized upon discharge from the Emergency Department into three groups: oral paracetamol-tramadol group, oral paracetamol-caffeine group and oral placebo group.

Detailed description: This is a prospective, randomized, single-blind study. Patients included in the study after successful treatment of the acute attack were randomized upon discharge from the Emergency Department into three groups: oral paracetamol-tramadol group, oral paracetamol-caffeine group and oral placebo group.

Different parameters are collected on a standard form prepared for all cases of renal colic included in our study. This sheet essentially contains:

Temperature, systolic and diastolic blood pressure, heart rate, pain intensity assessed by VAS, abdominal tenderness as well as the existence of Giardano signs.

Additional examinations were not systematically carried out for all patients: AUSP, ECBU, renal ultrasound, creatinemia and blood sugar. Their realization depended on the clinical context.

The use of imaging was done following the indications specified in the text of the consensus of the French Society of Emergency Medicine (updated in 2008)

Eligibility criteria: Inclusion Criteria:

* -Age \> 18 years old.
* Consent to participate in the study.
* Pain in the flank/lumbar fossa of sudden onset with urine strips and/or imaging corresponding to the diagnosis of renal colic.
* Pain score at discharge \< 30 (visual analog scale - VAS or verbal numerical scale - VAS from 0 to 100).

Exclusion Criteria:

* -Inability to appreciate pain according to the VAS.
* Pregnant or breastfeeding woman.
* Renal insufficiency with creatinine clearance \< 60 ml/min.

Primary outcomes:
measure: Recurrence of RC and ED readmission
timeFrame: 7 day after inclusion
Secondary outcomes:
measure: mean time interval
timeFrame: 7 day after inclusion
measure: side effects
timeFrame: 7 days 30 days
Other outcomes:
measure: Adverse effects
timeFrame: 7 days 30 days
Locations:
city: Monastir
country: Tunisia
facility: Semir Nouira
Study officials:
affiliation: CHU Fattouma Bourguiba Monastir, service des urgences
name: Khaoula Bel Haj Ali
role: STUDY_DIRECTOR
References:
Clinical trial NCT06825416: Phase III Clinical Study of SHR-2004 Injection in Preventing Venous Thromboembolism in Patients Undergoing Total Knee Arthroplasty
Official title: Multicenter, Randomized, Double-blind, Active-controlled Phase III Clinical Study to Evaluate the Efficacy and Safety of SHR-2004 Injection in the Prevention of Venous Thromboembolism in Patients Undergoing Elective Total Knee Arthroplasty
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Prevention of Arterial and Venous Thrombosis
Lead sponsor: Beijing Suncadia Pharmaceuticals Co., Ltd
Sponsor class: INDUSTRY
First posted: 2025-02-13
Enrollment: 1167
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of the study is to evaluate the efficacy and safety of SHR-2004 in preventing venous thromboembolism after elective unilateral total knee arthroplasty.


Eligibility criteria: Inclusion Criteria:

1. Understand the research procedures and methods, volunteer to participate in this trial, and sign the informed consent form in writing;
2. Planned elective schedule total knee arthroplasty (TKA) patients;
3. Men or women who are ≥ 18 years old and \< 80 years old on the day of signing the informed consent form.

Exclusion Criteria:

1. Unable to receive CT angiography of both lower limbs;
2. Malignant tumor within one year of the screening;
3. Myocardial infarction, transient ischemic attack or ischemic stroke occurred within 6 months of the screening;
4. Any medical history that may increase the risk of bleeding or any conditions that the investigator considers to increase the risk of bleeding;
5. History of drug abuse;
6. Pregnant or lactating women.

Primary outcomes:
measure: Incidence of asymptomatic deep vein thrombosis (DVT)
timeFrame: Day 12.
measure: Incidence of non-fatal pulmonary embolism (PE)
timeFrame: Day 12.
Secondary outcomes:
measure: Adverse events (AEs)
timeFrame: Day 65.
measure: Bleeding events
timeFrame: Day 12.
Other outcomes:
Locations:
city: Beijing
country: China
facility: Fourth Medical Center of Chinese People's Liberation Army General Hospital
state: Beijing
city: Changsha
country: China
facility: Xiangya Hospital, Central South University
state: Hunan
Study officials:
References:
Clinical trial NCT06001216: The Relationship of ACWR and FMS With Injury Risk in Adolescent Players
Official title: The Relationship of Acute-Chronic Workload Ratio and Functional Movement Screen With Injury Risk in Adolescent Team Sport Players
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Injury;Sports
Lead sponsor: Hacettepe University
Sponsor class: OTHER
First posted: 2023-08-21
Enrollment: 60
Sex: ALL
Minimum age (years): 15
Maximum age (years): 25
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: All volunteer employees who are over the age of 15, have been playing a team sport for at least one year, have not been away from their spor for more than two weeks and meet the inclusion criteria of the study will be included.

Brief summary: In this study, we examine how acute to chronic workload ratio and functional movement screen scores relate to injury risk in teenage athletes who play team sports.

Detailed description: At least 60 volunteer athletes who have played team sport for at least 1 year, have not been away from the field for more than 2 weeks, 15 years and older are planned to include this study. All participating athletes in this study will sign an informed consent form then their demographic information will be recorded. The injury risk of athletes will be evaluated by functional movement screen. The functional movement screen is a test battery consisting of 7 tests. These tests are deep squat, hurdle step, in-line lunge, active straight-leg raise, trunk stability push-up, rotary stability and shoulder mobility. To calculate the acute-chronic workload, internal workloads during training and/or matches will be added up over a period of 8 weeks. As part of the study, health professionals on the team will provide injury information for the athletes. Sports injuries will be classified based on the type of injury (contact or non-contact) and the area of the body affected. The severity of the injury will be determined as follows: minimal (1-3 days of missed sports activity), mild (4-7 days of missed sports activity), moderate (1-4 weeks of missed sports activity), and severe (4 or more weeks of missed sports activity).

Eligibility criteria: Inclusion Criteria:

* Be over 16 years old,
* Participating in a team sport for at least one year,
* The players who have not stayed away from their sport for more than two weeks,

Exclusion Criteria:

* Any history of orthopedic or neurological injury or pain that may interfere with normal training or competition during assessment,
* Structural deformities such as scoliosis and leg length inequality,
* Their level of activity differs from other athletes in the same sport will be excluded from the study.

Primary outcomes:
measure: Functional Movement Screen
timeFrame: baseline
measure: Acute chronic workload ratio
timeFrame: 8 weeks
measure: Injury
timeFrame: 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02024516: The Effect of Concentrated Pomegranate Juice Consumption on Lipid Profile and Inflammatory Factors in Patients With Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Type 2 Diabetes
Keywords: Type 2 diabetes
Pomegranate
Inflammation
lipid profiles
Lead sponsor: Ahvaz Jundishapur University of Medical Sciences
Sponsor class: OTHER
First posted: 2013-12-31
Sex: ALL
Minimum age (years): 25
Maximum age (years): 60
Standard ages: ADULT
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The aim of this study is to examine the effects of concentrated pomegranate juice on serum lipid profile and some inflammatory factors in patients with type 2 diabetes. Forty patients aged between 25-60 years old from both sexes are recruited. Patients consume 50gr/day concentrated pomegranate juice for 4 weeks. Anthropometric and blood pressure measurements, 3-days food-record questionnaire ,physical activity and fasting blood samples were collected at the beginning and at the end of the study. Fasting blood sugar, lipid profile, TNF- a, IL-6,hs -CRP and adiponectin levels are measured. LDL are calculated by formula. The participants are asked not to change their regular diet, medicine and activity during the study.


Eligibility criteria: Inclusion Criteria:

* male or female 25 to 60 years old
* having type 2 diabetes for at least 6 month

Exclusion Criteria:

* pregnancy
* lactation
* cardiac disease
* hepatic disease
* respiratory disease
* chronic renal diseases
* acute or chronic inflammation
* retinopathy
* intake of antioxidant supplement
* insulin therapy
* sensitivity to concentrated pomegranate juice
* change oral drug for controlling blood glucose

Primary outcomes:
measure: Triglyceride change
timeFrame: Baseline and after 4 weeks
measure: Total Cholesterol change
timeFrame: Baseline and after 4 weeks
measure: HDL- Cholesterol change
timeFrame: Baseline and after 4 weeks
measure: LDL- Cholesterol change
timeFrame: Baseline and after 4 weeks
measure: hsCRP change
timeFrame: Baseline and after 4 weeks
measure: TNF- α change
timeFrame: Baseline and after 4 weeks
measure: IL-6 change
timeFrame: Baseline and after 4 weeks
measure: adiponectin change
timeFrame: Baseline and after 4 weeks
Secondary outcomes:
measure: Fasting Blood Sugar change
timeFrame: baseline and after 4 weeks
measure: Blood Pressure change
timeFrame: Baseline and after 4 weeks
measure: Body Mass Index change
timeFrame: baseline and after 4 weeks
Other outcomes:
Locations:
city: Ahvaz
country: Iran, Islamic Republic of
facility: Ahvaz Jundishapoor University of Medical Sciences
state: Khoozestan
Study officials:
References:
Clinical trial NCT03762616: Urology San Antonio MRI/MicroUS Comparison
Official title: Urology San Antonio MRI/MicroUS Comparison
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prostate Cancer
Keywords: multiparametric MRI
micro-ultrasound
prostate biopsy
Lead sponsor: Exact Imaging
Sponsor class: INDUSTRY
First posted: 2018-12-04
Enrollment: 120
Sex: MALE
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: DIAGNOSTIC

Brief summary: This study compares micro-ultrasound image targeted prostate biopsy with multi-parametric MRI targeted biopsy in men indicated for prostate biopsy due to suspicion of prostate cancer. Both imaging techniques will be applied to each subject and compared, along with systematic biopsy.

Detailed description: The investigational protocol describes a study designed to compare ultra-high resolution transrectal micro-ultrasound (micro-US), and multi-parametric MRI (mpMRI). These modalities are both used clinically to identify targets for prostate biopsy, however little data is available to compare their sensitivity. While mpMRI is used clinically to identify targets for biopsy, it is not used for real-time biopsy guidance due to challenges performing the biopsy procedure within the MRI gantry. Instead, targets identified on mpMRI are sampled during transrectal ultrasound guided biopsy as part of the prostate biopsy procedure, often using software assisted fusion products. For this investigation, the biopsy procedure will be guided by transrectal micro-US (current standard of care at Urology San Antonio), and will include systematic (standard, random, extended sextant) plus image-guided prostate biopsies among men with clinical suspicion of prostate cancer and an indication for prostate biopsy.

Eligibility criteria: Inclusion Criteria:

1. Men presenting for prostate biopsy due to clinical suspicion of prostate cancer
2. 40-75 years old
3. Available mpMRI images and report, performed according to the PI-RADS v2 standard

Exclusion Criteria:

1. Men with anorectal abnormalities preventing TRUS-guided prostate biopsy
2. Men who are unable to provide their own informed consent
3. Prostate volume on MRI \> 100cc

Primary outcomes:
measure: Number of Participants With Clinically Significant Cancer
timeFrame: At time of biopsy
Secondary outcomes:
Other outcomes:
Locations:
city: San Antonio
country: United States
facility: Urology San Antonio - Pasteur Plaza Surgery Center
state: Texas
Study officials:
affiliation: Urology San Antonio
name: David R Talley, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02842216: Retrospective Analysis of Hospital Medical Records on Medication and Supplement Use in Pregnant Women
Official title: Retrospective Analysis of Hospital Medical Records on Medication and Supplement Use in Pregnant Women
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Medication and Supplement Use During Pregnancy
Keywords: Pharmaceutical preparations
Dietary supplements
Lead sponsor: KU Leuven
Sponsor class: OTHER
Collaborators: name: Universitaire Ziekenhuizen KU Leuven
First posted: 2016-07-22
Enrollment: 1200
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pregnant women who delivered in the University Hospital of Leuven

Brief summary: Monocentric study in University Hospitals Leuven (campus Gasthuisberg).

Hospital medical records from all pregnant women who delivered between 01/07/2015 and 31/12/2015 in University Hospitals will be analyzed for the presence of medication and supplements.

Some demographic and obstetric parameters will be collected as well.

The anonymized dataset will be analyzed using descriptive statistics (Excel). There will be no intervention among the selected sample.


Eligibility criteria: Inclusion Criteria:

* All pregnant women who delivered in the University Hospital of Leuven between 01/07/2015 and 31/12/2015

Primary outcomes:
measure: Number of registered medicines and supplements in hospital medical records of Belgian pregnant women
timeFrame: Hospital medical records from 11 months before delivery until 1 month postpartum
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02556216: Systematic Study of Parameters of Chronic Kidney Disease Mineral and Bone Disorder (CKD-MBD)
Official title: Systematic Study of Parameters of Chronic Kidney Disease Mineral and Bone Disorder (CKD-MBD)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Renal Osteodystrophy
Keywords: bone biopsy; bone density
Lead sponsor: Hannover Medical School
Sponsor class: OTHER
Collaborators: name: University of Jena
First posted: 2015-09-22
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with chronic kidney disease (including kidney transplanted patients) with mineral and bone disease

Brief summary: Bone and mineral disease is a key problem in patients with kidney disease. The available clinical parameters are non-specific, unproven for the assessment of the bone metabolism and do not reflect the complexity and diversity of the underlying bone pathology. The aim of this study is to use bone histology, novel bone markers and bone imaging results to establish a reliable decision model (diagnostic tool) that can be used to guide the individual therapy.

Detailed description: Bone and mineral disease is a key problem in patients with kidney disease. The available clinical parameters are non-specific, unproven for the assessment of the bone metabolism and do not reflect the complexity and diversity of the underlying bone pathology.

In this study bone histology parameters including results of tetracycline labeling will be compared to non-invasive parameters of bone metabolism (e.g. sclerostin, calciprotein particles) and bone structure obtained by imaging (e.g. bone density).

The aim of the study is to establish a reliable decision model (diagnostic tool) with these non-invasive parameters that can be used to guide the individual therapy. The decision model will be based on single calculations of the area under the curve for each parameter, including determination of the optimal cutpoint, sensitivity and specificity. These results will be integrated in a multivariate logistic regression analysis. The resulting model will enable to calculate the individual probability of the underlying bone diagnosis as a single value (without a specific dimension).

Eligibility criteria: Inclusion Criteria:

* Patients with kidney disease who have an indication for a bone biopsy, based on clinical, laboratory and radiologic findings

Exclusion Criteria:

* known malignant bone or bone marrow disease

Primary outcomes:
measure: Accuracy of a diagnostic model (derived from the non-invasive radiologic and blood parameters of the bone) in relation to the 'gold standard' bone biopsy result
timeFrame: cross-sectional study, one week
Secondary outcomes:
Other outcomes:
Locations:
city: Hannover
country: Germany
facility: Hannover Medical School
Study officials:
affiliation: Hannover Medical School
name: Margret Patecki, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00836316: Levobupivacaine During Cholecystectomy
Official title: Effects of Intraperitoneal Levobupivacaine on Pain After Laparoscopic Cholecystectomy: A Prospective, Randomized, Double-Blinded Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Cholelithiasis
Pain
Keywords: laparoscopic cholecystectomy
Lead sponsor: Ege University
Sponsor class: OTHER
First posted: 2009-02-04
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine the effects of intraperitoneal administration of levobupivacaine on pain after laparoscopic cholecystectomy.


Eligibility criteria: Inclusion Criteria:

* cholelithiasis
* chronic cholecystitis

Exclusion Criteria:

* hypersensitivity to local anesthetics
* acute cholecystitis
* morbid obesity

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Izmir
country: Turkey
facility: Ege University School of Medicine
Study officials:
References: