louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05023395: Safety and Efficacy of MEE-HU Medicus
Official title: Safety and Efficacy of an Investigational Medicinal Product "MEE-HU Medicus",in Combination With Antimicrobial, in Urinary Tract Infection A Randomized, Double Blind, Placebo Controlled, Multicenter Study (SEM)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Urinary Tract Infections
Lead sponsor: Heliopolis University
Sponsor class: OTHER
Collaborators: name: Theodor Bilharz Research Institute
name: The Cairo Kidney Center
name: Helwan University
name: Zagazig University
First posted: 2021-08-26
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Primary objective: is evaluation of the investigational product's safety and evaluation of its effect, in combination with antimicrobial treatment, on urine culture (microbiological cure, no microbial growth on 24-48 hrs culture). The secondary objective: is evaluation of the investigational product's effect, in combination with antimicrobial treatment, on disease related symptoms (Clinical cure, disappearance of symptoms and signs).

Detailed description: Design: Randomized, Double blind, Placebo controlled multicenter study. Recurrent urinary tract infection patients will blindly receive MEE-HU Medicus, or matching placebo, orally, daily, for 10 days, adjunct to the empirical antibiotic.

Population: Male and female patients over 18 years old diagnosed with recurrent urinary tract infection. Sample Size: 200 patients, 100 from each center.

Eligibility criteria: Inclusion Criteria:

Male and female patients over 18 years old - Symptomatic urinary tract infection (pain, dysuria, frequency, urgency, fever) confirmed by urine analysis (Pyuria, which is defined as urine WBC \>10). - Negative pregnancy test and absence of vaginal discharge. - Recurrent urinary tract infection 2 times or more in the last 6 months or 3time or more in the last year. - Signed informed consent.

Exclusion Criteria Patients unable or unwilling to provide their free consent to participate in the study - Patients known or suspected to be hypersensitive to medications that will be used in the study. - Simultaneous participation in other studies. - Patients on palliative care, terminal illness. - Evidence of acute or chronic prostatitis or pyelonephritis. - History of antimicrobial use in the last 72 hrs. - Patients with renal transplantation.

Primary outcomes:
measure: Complete response status
timeFrame: 5-7 days after completion of treatment
Secondary outcomes:
measure: Incomplete response status
timeFrame: 5-7 days after completion of treatment
Other outcomes:
measure: - Failure status
timeFrame: 5-7 days after completion of treatment
measure: Recurrence
timeFrame: 60 ±10 days from the first day of the study drug administration
Locations:
city: Cairo
country: Egypt
facility: Cairo Kidney Center
city: Giza
country: Egypt
facility: Theodor Bilharz Research Institute
Study officials:
References:
Clinical trial NCT00960895: Pulmonary Hypertension in Lymphangioleiomyomatosis
Official title: Observational Study of Patients With Lymphangioleiomyomatosis and Pulmonary Hypertension
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lymphangioleiomyomatosis
Pulmonary Hypertension
Keywords: Lymphangioleiomyomatosis
Pulmonary hypertension
Lead sponsor: Groupe d'Etudes et de Recherche sur les Maladies Orphelines Pulmonaires
Sponsor class: OTHER
Collaborators: name: Hospices Civils de Lyon
First posted: 2009-08-18
Enrollment: 20
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Lymphangioleiomyomatosis, either sporadic or associated with tuberous sclerosis Precapillary pulmonary hypertension, as defined by right-sided heart catheterization (mean pulmonary artery pressure higher than 25 mmHg, wedge capillary pulmonary pressure less than 15 mmHg, pulmonary vascular resistance higher than 3 Wood units)

Brief summary: This is a descriptive study of patients with Lymphangioleiomyomatosis and precapillary pulmonary hypertension.

Detailed description: Descriptive study of patients with Lymphangioleiomyomatosis and precapillary pulmonary hypertension This will include modality of diagnosis of lLymphangioleiomyomatosis, results of right-sided heart catheterization, and pulmonary function tests

Eligibility criteria: Inclusion Criteria:

* Lymphangioleiomyomatosis (definite or probable), either sporadic or associated with tuberous sclerosis
* Precapillary pulmonary hypertension, as defined by right-sided heart catheterization (mean pulmonary artery pressure higher than 25 mmHg, wedge capillary pulmonary pressure less than 15 mmHg, pulmonary vascular resistance higher than 3 Wood units)

Exclusion Criteria:

* Post capillary pulmonary hypertension
* Other identifiable causes of pulmonary hypertension (ex: thromboembolic disease)
* Not willing to participate

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Lyon
country: France
facility: Louis Pradel Hospital
state: University of Lyon
Study officials:
affiliation: University of Lyon
name: Vincent Cottin, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03673995: Myoinositol Plus L-tyrosine, Selenium and Chromium in PCOS
Official title: Use of Myoinositol Plus L-tyrosine, Selenium and Chromium in PCOS Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Polycystic Ovary Syndrome
Menstrual Problem
Hirsutism
Lead sponsor: Pharmarte srl
Sponsor class: INDUSTRY
First posted: 2018-09-17
Enrollment: 186
Sex: FEMALE
Minimum age (years): 16
Maximum age (years): 38
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: PCOS patients were treated every day, with one sachet containing 2000 mg myo-inositol, 500 mg L-tyrosine, 40 mcg chromium picolinate, 55 mcg selenium, 200 mcg folic acid. All patients underwent, before starting the therapy, after 3 months and 6 months, hormonal evaluation , hirsutism scoring and ovulation assesment. Most of them during the treatment improved their symptoms.


Eligibility criteria: Inclusion Criteria:

° PCOS patients

Exclusion Criteria:

* thyroid dysfunction
* hyperprolactinemia
* adrenal hyperplasia
* patients taking oral contraceptive
* any other endocrinological pathologies

Primary outcomes:
measure: Restore of regular menstrual period
timeFrame: 6 months of treatment
Secondary outcomes:
measure: Improving hirsutism
timeFrame: 6 months of treatment
measure: Restore ovulation
timeFrame: 6 months of treatment
Other outcomes:
Locations:
city: Roma
country: Italy
facility: Altamedica Reproductive Medicine
Study officials:
affiliation: Altamedica Reproductive Medicine
name: Mario Montanino Oliva, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02445495: Chart Review of the Efficacy of the GenesisPlus 1064 nm Nd:YAG Laser in the Treatment of Onychomycosis
Official title: A Single Centre Retrospective Chart Review Study to Assess the Efficacy of the GenesisPlus 1064 nm Nd:YAG Laser in the Treatment of Onychomycosis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Onychomycosis
Lead sponsor: Pacific Dermaesthetics
Sponsor class: OTHER
Collaborators: name: Cutera Inc.
First posted: 2015-05-15
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 100 participants at primary clinic

Brief summary: The purpose of this study is to determine if toenail onychomycosis can be reduced by means of exposure to laser energy from the Cutera® GenesisPlus 1064 Nd:YAG laser system.

Detailed description: This is a retrospective, open-label, single-centre study for the collection of clinical data on the efficacy and safety of the Cutera® GenesisPlus 1064 nm Nd:YAG laser for the treatment of nail fungus (onychomycosis). Safety and efficacy of treatment with the GenesisPlus laser will be evaluated by (1) assessment of subject's great toenail photographs at baseline and after two treatments with GenesisPlus Laser utilizing planimetry measurement of infected vs. clear nail area in target toenail photographs, (2) by clinical and subjective review of acute and follow up adverse events that may have resulted from laser treatment of the target toenails.

Eligibility criteria: Inclusion Criteria:

1. Male or Female subjects, age 18 to 80 years (inclusive).
2. Subject with a clinical diagnosis of onychomycosis of one or both great toenails at baseline.
3. Subject with a positive potassium hydroxide (KOH) stain and/or fungal culture.
4. Subject has baseline and post treatment digital photographs of target great toenails.
5. Subjects provided informed consent for treatment of nails with the Cutera GenesisPlus laser system.

Exclusion Criteria:

1. Subjects have received laser treatment of the infected great toenail(s) with a non-Cutera® laser system within twelve (12) months prior to Cutera® GenesisPlus laser treatment.
2. Subjects have had a history or clinical diagnosis of moccasin type tinea pedis, lichen planus, psoriasis or bacterial nail infection.
3. Subjects had a history or clinical diagnosis of coexisting disorders that may potentially demonstrate nail manifestations.
4. Systemic antifungal medication within six (6) months prior to or following Cutera® GenesisPlus laser treatment.
5. Subjects who have had a history or clinical diagnosis of repetitive nail trauma prior to treatment.
6. Subjects who have participated in any clinical research study within thirty (30) days prior to or within 210 days following final Cutera® GenesisPlus laser treatment.
7. Subjects who were pregnant or breastfeeding.

Primary outcomes:
measure: change in % of infected toenail involvement
timeFrame: change from baseline up to 6 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03879395: Surgery for Gastrointestinal Metastases of Malignant Melanoma - a Single Center Retrospective Cohort Study
Official title: Surgery for Gastrointestinal Metastases of Malignant Melanoma - a Single Center Retrospective Cohort Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Melanoma Stage Iv
Melanoma Metastatic
Abdominal Tumor
Keywords: melanoma
abdominal metastasis
metastasectomy
tumor resection
M1c
Lead sponsor: Vastra Gotaland Region
Sponsor class: OTHER_GOV
First posted: 2019-03-18
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with abdominally metastasized malignant melanoma stage IV.

Brief summary: The aim is to conduct a single centre retrospective study of all patients with stage IV melanoma that underwent surgery for metastases at Sahlgrenska University Hospital between 2010-01-01 and 2018-12-31. Pre- and postoperative data will be collected from digital medical records, the Swedish Cancer Registry, the Swedish Cause of Death Register as well as from the national Swedish cancer patient database (INCA). If needed, patient records will be collected from other hospitals. Results will be presented in written format as a summary and analysis of the characteristics of the cases operated on during the inclusion period.

The aim is to identify predictive and prognostic factors for outcome and complications in the surgical treatment of stage IV metastatic melanoma.


Eligibility criteria: Inclusion Criteria:

* Biopsy verified stage IV malignant melanoma, stage M1c.
* Having undergone surgery with metastasectomy of melanoma tumors.

Exclusion Criteria:

* retroperitoneal tumors

Primary outcomes:
measure: Overall survival
timeFrame: December 2018
Secondary outcomes:
measure: Complications according to Clavien-Dindo within 90 days.
timeFrame: 90 days
Other outcomes:
Locations:
city: Gothenburg
country: Sweden
facility: Sahlgrenska University Hospital
Study officials:
References:
citation: Holmberg CJ, Alwan G, Ny L, Olofsson Bagge R, Katsarelias D. Surgery for gastrointestinal metastases of malignant melanoma - a retrospective exploratory study. World J Surg Oncol. 2019 Jul 12;17(1):123. doi: 10.1186/s12957-019-1663-z.
Clinical trial NCT05178095: Artificial Intelligence in Colonic Polyp Detection
Official title: Artificial Intelligence in Colonic Polyp Detection
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Polyp of Colon
Adenoma Colon
Gastrointestinal Neoplasms
Keywords: colonoscopy
artificial intelligence
Lead sponsor: Sahlgrenska University Hospital
Sponsor class: OTHER
First posted: 2022-01-05
Enrollment: 250
Sex: ALL
Minimum age (years): 40
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: A randomized, controlled study investigating the potential benefits of artificial intelligence (AI) in the detection of colonic polyps during outpatient colonoscopy. Randomization between the use of AI and no AI is performed before the study procedure.


Eligibility criteria: Inclusion Criteria:

* All patients without IBD referred for colonoscopy

Exclusion Criteria:

* Age \< 40 years
* Not willing to participate

Primary outcomes:
measure: ADR
timeFrame: 1 hour
Secondary outcomes:
measure: APC
timeFrame: 1 hour
measure: Procedural time
timeFrame: 1 hour
Other outcomes:
Locations:
city: Gothenburg
country: Sweden
facility: Dr Per Hedenström
Study officials:
affiliation: Sahlgrenska University Hospital
name: Björn Lindkvist
role: STUDY_DIRECTOR
References:
Clinical trial NCT04768595: Study of the Effect of Different Fish Oils on Omega-3 Index (CetoIndex)
Official title: A Nutritional, Placebo Controlled, Randomised, Blinded Study of the Effect of Different Fish Oils on Omega-3 Index (CetoIndex)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Healthy Volunteers
Lead sponsor: Epax Norway AS
Sponsor class: INDUSTRY
Collaborators: name: Møreforsking AS
First posted: 2021-02-24
Enrollment: 56
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The study determines the EPA DHA uptake from different omega-3 supplements against a control.

Detailed description: The chronic uptake of omega-3 fatty acids EPA and DHA are commonly determined by measurement of EPA and DHA in red bloods cells and presented as a % of total fatty acids, the so-called Omega-3 Index. The index is a validated risk assessment for cardiovascular disease. Different fish oils may influence the Omega-3 Index differently depending on their composition. This study assesses omega-3 commonly found as a supplement vs a fish oil based on north atlantic fish species.

Eligibility criteria: Inclusion Criteria:

1. Men or women, ≥18 -65 years of age.
2. Willing to refrain from taking omega-3 supplements for 1 month prior to study start
3. Willing to take study supplement for 2 months

Exclusion Criteria:

1. Subjects with known allergy to fish products
2. Subjects known to be pregnant or breast feeding

Primary outcomes:
measure: Change in Omega-3 index
timeFrame: Baseline (supplementation start: time point 0) to 2 months of supplementation
Secondary outcomes:
measure: Change in fatty acid profile from baseline to end of supplementation between study arms.
timeFrame: Baseline to 2 months of supplementation.
Other outcomes:
Locations:
city: Ålesund
country: Norway
facility: Møreforsking AS
Study officials:
affiliation: Møreforsking AS
name: Lisa Midtbø, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01436695: Safety and Feasibility of Using Epicall for Monitoring Pre-seizure Biomarkers
Official title: Safety and Feasibility of Using Epicall for Monitoring Pre-seizure Biomarkers
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Seizure
Keywords: seizure early detection
Lead sponsor: Epicall LTD
Sponsor class: INDUSTRY
First posted: 2011-09-20
Enrollment: 30
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Hospitalized patients who diagnosed with epilepsy and meet all of the eligibility criteria will be recruited for the study.

Brief summary: Epilepsy is a syndrome of episodic brain dysfunction characterized by recurrent seemingly unpredictable spontaneous seizures. The occurrence of the seizure in patients without any forewarning is the most debilitating aspect of the disease.

The Epicall system is intended for early detection of seizure related life threatening events by monitoring per-seizures biomarkers. The system is based on a sticker placed on the side of the face. The external sticker incorporates EOG (electrooculograph electrode) and PPG (photoplethysmograph electrode) sensors for continuous monitoring of:

1. Heart Rate (base line, increase, decrease, asystole).
2. Extra ocular eye movement (blinking, eye deviation, roving eye movements).


Eligibility criteria: Inclusion Criteria:

* Children age 1 year -18 years old.
* Hospitalized patient who is diagnosed with epilepsy.
* Patient's parents/care giver able to comprehend and give informed consent for participation in this study.
* Patient's parents/care giver must commit to both screening and monitoring visits.
* Patient's parents/care giver must sign the Informed Consent Form.

Exclusion Criteria:

* Patient with any infection / abscess / bleeding / blister / crack / edema / fissure / ulcer / pain in monitoring electrode area
* General weakness.
* Patient's parents/care giver objects to the study protocol.
* Concurrent participation in any other clinical study.
* Physician objection.

Primary outcomes:
measure: Lack of adverse events
timeFrame: 1-2 weeks
Secondary outcomes:
measure: Epicall feasibility for monitoring pre-seizure biomarkers
timeFrame: 1-2 weeks
Other outcomes:
Locations:
city: Zrifin
country: Israel
facility: Asaf Harofeh Medical Center
Study officials:
affiliation: Asaf-Harofeh Medical Center, Zrifin Israel
name: Eli Heyman, Dr
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06080295: The Kallikrein-Kinin System in Cardiac Surgery
Official title: The Involvement of the Kallikrein-Kinin System in the Pathogenesis of Postoperative Injury in Cardiac Surgery: An Observational Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiosurgery
Keywords: KKS; tissue kallikrein; ;cardiosurgery;cardiopulmonary bypass
Lead sponsor: Tongji Hospital
Sponsor class: OTHER
First posted: 2023-10-12
Enrollment: 308
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients undergoing cardiac surgery: (coronary artery bypass grafting, heart valve surgery, Morrow operation, aortic dissection surgery).

Brief summary: We aimed to established an interlink among the kallikrein-kinin system (KKS), endothelial dysfunction and cardiac inflammation in response to cardiosurgery , using clinic investigation.

Detailed description: The KKS, which is located on the vascular endothelium, plays a pivotal role in maintaining cardiovascular homeostasis. Tissue kallikrein (TK), a serine protease and a key enzyme of the KKS, is responsible for cleaving low-molecular-weight kininogen into bradykinin and kallidin. Under normal physiological conditions, the activation of the B2 receptor (B2R)/endothelial nitric oxide synthase (eNOS) signaling pathway leads to the transient release of nitric oxide (NO), resulting in cardiovascular protection. However, during reperfusion injury, the activation of the B1 receptor (B1R)/inducible nitric oxide synthase (iNOS) pathway leads to excessive NO production, promoting inflammation and cellular injury. Therefore, it is hypothesized that the KKS plays a critical role in the early stages of reperfusion injury during cardiac surgery with cardiopulmonary bypass.

Eligibility criteria: Inclusion Criteria:

1) Willing to participate in the study. 2) Age ≥ 18 years and ≤ 80 years. 3) Patients undergoing cardiac surgery: (coronary artery bypass grafting, heart valve surgery, Morrow operation, aortic dissection surgery).

Exclusion Criteria:

1) Patients with heart failure. 2) Patients experiencing adverse events during surgery. 3) Solid organ or bone marrow transplant recipients. 4) Patients with autoimmune diseases, tumors, or those who received high-dose steroid or immunosuppressant therapy within the past two months. 5) Deemed unsuitable for participation in this study by the researchers' judgment.

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Primary outcomes:
measure: survival
timeFrame: 24 hours
measure: Cardiac function
timeFrame: 24 hours
measure: POD-postoperative delirium
timeFrame: 7 days
Secondary outcomes:
measure: survival
timeFrame: 28 days
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
state: Hubei
Study officials:
affiliation: Tongji Hospital
name: Qin Zhang, phd
role: PRINCIPAL_INVESTIGATOR
References: