louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01021267: Clinical Study to Assess the Influence of a Saw Palmetto Preparation in Patients With Benign Prostatic Hyperplasia (BPH) and Sexual Dysfunctions
Official title: Clinical Pilot Trial on the Influence of a Saw Palmetto Berry Preparation on Sexual Functions in Patients With Benign Prostatic Hyperplasia
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Sexual Dysfunctions in Men With Benign Prostatic Hyperplasia
Keywords: sexual dysfunctions
benign prostatic hyperplasia
saw palmetto
Lead sponsor: A. Vogel AG
Sponsor class: INDUSTRY
Collaborators: name: University of London
First posted: 2009-11-26
Enrollment: 50
Sex: MALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Assessment in an open trial if a standardized saw palmetto preparation has a positive influence on sexual dysfunctions in patients with BPH and sexual dysfunctions.


Eligibility criteria: Inclusion Criteria:

* Patients with BPH and sexual dysfunctions (erectile dysfunction or decrease in libido)
* IPSS \> 4
* BSFI, sexual drive questions \< 5

Exclusion Criteria:

* Lack of libido which is due to a psychic disease or a depressive mood -Excessivly strong lack of libido in the judgement of the investigator within the last two months
* Patients with severe vascular disorders (microangiopathies)
* Patients with known neuropathies
* Severe diabetes mellitus
* Patients with hypertension who are for less than two months on a stable antihypertensive medication
* Known bad compliance of the patient

Primary outcomes:
measure: Change of the brief Sexual Function Inventory
timeFrame: day 0 and day 56
Secondary outcomes:
measure: change in IPSS change in Urolife Quality of Life questionnaire
timeFrame: day 0 and day 56
Other outcomes:
Locations:
city: Chur
country: Switzerland
facility: Dr. Eugen Riedi
Study officials:
affiliation: independent
name: Eugen Riedi, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04984967: Interest of Peripheral Venous Catheter Insertion Using a Micro-guide in Neonatology
Official title: Comparison of Two Techniques of Peripheral Venous Catheterization in Newborns : Insertion on Micro-guide Versus Conventional Insertion, Without Micro-guide
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Newborns
Neonatology
Intensive Care
Keywords: Newborn infant
Intensive care
vascular access
Peripheral intravenous catheterization
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2021-08-02
Enrollment: 116
Sex: ALL
Maximum age (years): 28
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Peripheral venous catheterization represents the preferential option for term or preterm infant care in order to start drug treatment or hydration, or perform anesthesia.

However, the peripheral venous access is associated in approximately 50% of cases with a failure of the insertion on the first attempt in an emergency context. Using a micro-guide may facilitate the peripheral venous catheterization in newborns, by guiding the catheter in the vein and, thereby reduce the risk of transfixion of the vascular lumen.


Eligibility criteria: Inclusion Criteria:

* Newborn admitted in the department of neonatal medicine and pediatric intensive care, at Montpellier University Hospital

Exclusion Criteria:

* Term neonate \> 28 days
* Premature neonate \> 41 weeks of corrected gestational age
* Exclusive requirement for an umbilical venous catheter, in the context of neonatal resuscitation
* Exclusive requirement for an epicutaneous-cava catheter, in the context of prolonged parenteral nutrition.

Primary outcomes:
measure: Success of peripheral venous catheterization at the first attempt
timeFrame: Up to 5 minutes after the success of the placement
Secondary outcomes:
measure: Efficiency of the technique
timeFrame: Up to 4 days.
measure: Efficiency of the technique
timeFrame: Up to 4 days.
measure: Efficiency of the technique
timeFrame: Up to 4 days.
measure: Efficiency of the technique
timeFrame: Up to 4 days.
measure: Adverse events
timeFrame: Up to 4 days.
measure: Adverse events
timeFrame: Up to 1 month.
Other outcomes:
Locations:
city: Montpellier
country: France
facility: University Hospital Montpellier
Study officials:
References:
Clinical trial NCT03085667: Impact of Implantation of an LAA Occluder on ANP and BNP Level and Quality of Life
Official title: Impact of Implantation of an LAA Occluder on ANP and BNP Level and Quality of Life
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Atrial Fibrillation
Keywords: Left atrial appendage occluder
Watchman device
Atrial fibrillation
atrial natriureitc peptide
brain natriuretic peptide
Lead sponsor: University of Leipzig
Sponsor class: OTHER
First posted: 2017-03-21
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Consecutive patients undergoing left atrial appendage closure

Brief summary: Closure of the LAA by several devices is a alternative therapy to oral anticoagulation in patients with Atrail fibrillation. Nothing is known about the acute influence of a device closure of the LAA on the secretion of ANB nad BNP hormones. Therefore aim of our study is to measure ANB and BNP levvels before and after Implantation of an LAA closure device.

Detailed description: ANB and BNP levels are measured before, directly after and late after 24 h in central or periphereal venous blood from patients undergoing interventional LAA closure.

Eligibility criteria: Inclusion Criteria:

* patients undergoing LAA closure

Exclusion Criteria:

* none

Primary outcomes:
measure: Change from baseline atrial natriuretic Peptide (ANP)
timeFrame: 24 h post intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Leipzig
country: Germany
facility: Heart Center Leipzig- University Leipzig
Study officials:
affiliation: University of Leipzig
name: Sven Möbius-Winkler, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06457867: Assessment of Microfragmented Adipose Tissue Loaded on Bovine Graft Versus Bovine Graft Only on Ridge Preservation.
Official title: Radiographic and Histomorphometric Assessment of Microfragmented Adipose Tissue Loaded on Bovine Graft on Ridge Preservation Versus Bovine Graft Only for Subsequent Implant Placement in the Maxillary Posterior Region, a Randomized Clinical Trial.
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Tooth Mobility
Keywords: unrestorable caries lesions or affected periodontium.
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2024-06-13
Enrollment: 22
Sex: ALL
Minimum age (years): 21
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Evaluation of maxillary alveolar ridge changes (bone quantity and quality as revealed by Radiographic and Histomorphometry) utilizing microfragmented adipose tissue loaded on bovine graft versus bovine graft only for maxillary posterior ridge preservation.

Detailed description: All patients involved in this study will be divided into two groups; each group will receive a different graft of bone augmentation: Adipose tissue loaded on bovine graft will be utilized for the study group and bovine raft only for the control group.

After 6 months, patients will be evaluated histomorphometrically via core biopsy at the time of implant placement and radiographically via assessment of ridge height on CBCT.

Radiographic assessment that will be achieved by CBCT scan will be used to calculate the changes of bone height from base line (1week) to 6 months postoperatively.

Eligibility criteria: Inclusion Criteria:

* Patients requiring implant treatment after tooth extraction due to either unrestorable caries lesions or affected periodontium.

  * Age group: above 21 years
  * Remaining natural teeth have good periodontal tissue support and occlusion showed sufficient inter arch space for future prosthesis.

Exclusion Criteria:

* General contraindications to implant surgery.

  * Subjected to irradiation in the head and neck area less than 1 year before implantation.
  * Poor oral hygiene and motivation.
  * Severe bruxism or clenching.
  * Systemic, immunologic, or debilitating diseases that could affect normal bone healing \& local pathosis.
  * Treated or under treatment of intravenous amino bisphosphonates.
  * Active infection or severe inflammation in the area intended for implant placement.
  * Patients participating in other studies if the present protocol could not be properly followed.
  * Heavy smokers

Primary outcomes:
measure: Quantity of bone (vertical bone height)
timeFrame: Quantity of bone (vertical bone height) by CBCT after 6 months
Secondary outcomes:
measure: Quality of bone
timeFrame: Histological analysis (Core biopsy) Percentage of newly formed bone after 6 months
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01954667: Anthropometric Measures and Severity of Gastroesophageal Reflux Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Gastroesophageal Reflux Disease
Keywords: Gastroesophageal Reflux Disease; Anthropometric Measures; Leptin
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2013-10-07
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This prospective, case-controlled study included 60 Egyptian patients who attended Ain Shams University Hospitals and Theodor Bilharz Research Institute; Cairo, Egypt

Brief summary: evaluate the impact of different anthropometric measures on clinical and endoscopic severity of GERD and its relation to serum leptin.


Eligibility criteria: Inclusion Criteria:

* Gastro esophageal reflux symptoms (e.g. heart burn, regurgitation, water brash or atypical symptoms such as hoarseness of voice, asthma and cough)
* complete upper gastrointestinal endoscopy.

Exclusion Criteria:

* Receiving medication for reflux disease (including proton pump inhibitor, histamine type 2 receptors blocker, prokinetic agents) in the previous month.
* Pregnant woman.
* History of upper abdominal surgery.
* Severe co-morbidity as cirrhosis, end-stage renal disease and heart failure.

Primary outcomes:
measure: Impact of anthropometric measures on GERD
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Tropical medicine department
Study officials:
References:
Clinical trial NCT05772767: Modulation of Ciliogenesis in Glioma Stem Cells
Official title: Control of Growth and Invasiveness of Glioblastoma by Modulation of Ciliogenesis in Glioma Stem Cells. A Novel Target Against Glioblastoma for Precision Medicine. RF-2019-12368786
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Glioblastoma
Glioma, Malignant
Keywords: cilia disassembly complex
Nek2
glioblastoma stem cells
Lead sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Sponsor class: OTHER
Collaborators: name: Istituto Superiore di Sanità
name: Fondazione C.N.R./Regione Toscana "G. Monasterio", Pisa, Italy
First posted: 2023-03-16
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The study aims at investigating the cilium-related transcriptome in patients-derived glioblastoma stem cells and the potential impact of modulation of cilium players in vitro, in vivo and ex vivo in glioblastoma brain organoids. Moreover, drugs inhibiting cilia disassembly will be tested. Finally, the potential prognostic role of a cilium-related gene expression signature in glioblastoma will be assessed.


Eligibility criteria: Inclusion Criteria:

To be enrolled in the study patients must:

1. Have a radiological diagnosis of supratentorial glioblastoma, or
2. Have a radiological diagnosis of first recurrence of a primary supratentorial glioblastoma (for which a formal histopathologic diagnosis of glioblastoma had been made at first surgery), according with RANO criteria (Wen, 2010);
3. Be a candidate to neurosurgery for glioblastoma at the Operational Unit of Neurosurgery FPG;
4. Be of an age of 18 years or above;
5. Provide written informed consent for participation to the study.

Exclusion criteria

To be enrolled in the study patients must not:

1. Have not enough pathological material removed at surgery available both for mandatory routine histopathological diagnosis and for the present study, as judged by the Principal Investigator;
2. Have not a definitive pathological diagnosis of a primary supratentorial GBM, according with 2016 WHO classification.

Primary outcomes:
measure: Biological
timeFrame: Through study completion, an average of 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Rome
country: Italy
facility: Fondazione Policlinico Universitario A. Gemelli IRCCS
Study officials:
affiliation: Fondazione Policlinico Universitario A. Gemelli, IRCCS
name: Roberto Pallini, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06538467: Comparison of Architectural and Performance Adaptations of Hip Extension Exercise Under Gravitational or Inertial Loading Conditions
Official title: Comparison of Architectural and Performance Adaptations of Hip Extension Exercise Under Gravitational or Inertial Loading Conditions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Injury;Sports
Lead sponsor: University of Valencia
Sponsor class: OTHER
First posted: 2024-08-05
Enrollment: 32
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The main objective of this study is to investigate training-induced adaptations in Biceps femoris long head (BFlh) architecture and performance measures such as muscle strength, jumping, and power variables after following 6 weeks of resistance training program with gravitational or inertial hip extension (HE) exercise and a subsequent detraining period, comparing those adaptations with a control group. In addition, this study aims to determine the time course of BFlh architectural adaptations throughout a 6-week training intervention.


Eligibility criteria: Inclusion Criteria:

* at least two years of resistance training experience
* not have any injury, disease or pain that could reduce their maximal effort

Exclusion Criteria:

* history of injury to the lower limbs (including the hamstrings), wrist, or back in the past 18 months

Primary outcomes:
measure: Fascicle length
timeFrame: Baseline, at weeks 2 and 3 of the intervention, at the end of the 6 weeks of training and 4 weeks after this (detraining period)
measure: Muscle Strength Assessment
timeFrame: Baseline, at the end of the 6 weeks of training and 4 weeks after this (detraining period)
measure: Jump performance
timeFrame: Baseline, at the end of the 6 weeks of training and 4 weeks after this (detraining period)
measure: Power
timeFrame: Baseline, at the end of the 6 weeks of training and 4 weeks after this (detraining period)
measure: Soreness
timeFrame: From session 1 (the beginning of week 1) to session 12 (the end of week 6), at the beginning and end of each session.
Secondary outcomes:
Other outcomes:
Locations:
city: Valencia
country: Spain
facility: Rodrigo Martin-San Agustin
Study officials:
affiliation: University of Valencia
name: Rodrigo Martín-San Agustín
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04492267: Inflammatory Bowel Disease (IBD) and Covid-19 Infection
Official title: SARS-CoV-2 Infection in Patients From Two Tertiary Inflammatory Bowel Disease (IBD) Centres: Frequency of Suspected and Confirmed Infections, Severity and Outcome Management
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Inflammatory Bowel Disease
Keywords: SARS-CoV-2
Inflammatory Bowel Disease
IBD
Crohn's disease
Ulcerative colitis
Immunosuppressant therapy
Biologicals
Severe respiratory disease
intensive care unit
Mechanical ventilation
Death
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2020-07-30
Enrollment: 700
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: IBD patient (Crohn's disease, ulcerative colitis, indeterminate colitis) over the age of 18 years

Brief summary: Most of the inflammatory bowel disease (IBD: Crohn's disease and ulcerative colitis) in a tertiary expert Centre are on immunosuppressive and/or biological therapy. Theoretically, these treatments may increase patients' risk of infection, in particular viral infection. Therefore, the current SARS-Cov-2 pandemia, with its unprecedent worldwide morbidity and mortality, may have a negative impact on IBD patients' clinical course. Identifying an increased risk in this particular patients' population as well as the risk/protective factors is of outstanding importance, in order to adapt their treatment and surveillance. As a consequence, our aims were (i) to measure retrospectively the risk of SARS-CoV-2 (proven by biological testing or suspected due to record of potential clinical symptoms of COVID-19 infection) in this patients' cohort (principal objective), (ii) to identify risk or protective factors for SARS-CoV-2 infection in IBD, and (iii) to analyze the outcome of patients in case of suspected or confirmed COVID-19. The results of this study may be important to adjust our surveillance and therapeutic strategy in these patients, in particular if high virus circulation will occur in the future.


Eligibility criteria: Inclusion Criteria:

* Patient over the age of 18 years
* IBD patients (Crohn's disease, ulcerative colitis, indeterminate colitis)
* Patient agreeing to participate in the study

Exclusion Criteria:

* Patient unable to understand the study protocol or to answer simple anamnestic questions due to language barrier
* Patient under guardianship or trusteeship
* Patient under safeguard of justice

Primary outcomes:
measure: Retrospective analysis of severity and specific needs in case of SARS-CoV-2 infection in IBD patients
timeFrame: Files analysed retrospectily from March 1st, 2020 to July 31, 2020 will be examined
Secondary outcomes:
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Service Hépato-Gastroentérologie et Assistance Nutritive Hôpitaux Univesitaires de Strasbourg
Study officials:
References:
Clinical trial NCT05831267: Fibrin Glue Versus Titanium Platelet-rich Fibrin in Lateral Sinus Lifting
Official title: Fibrin Glue Versus Titanium Platelet-rich Fibrin as a Sole Filling Material in Lateral Sinus Lifting With Simultaneous Implant Placement (Randomized Controlled Clinical Trial )
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sinus Floor Augmentation
Graftless Sinus Elevation
Keywords: Tenting implant
Fibrin glue
T-PRF
Lead sponsor: Alexandria University
Sponsor class: OTHER
First posted: 2023-04-26
Enrollment: 30
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Graftless sinus lift with simultaneous implant placement is one of the new techniques, this new technique is presented based on the physiology of intrasinus bone repair.

Schneiderian membrane is known to have an osteogenic nature, now blood clot can be considered autologous osteogenic graft material, to which osteoprogenitors can migrate, differentiate, and regenerate bone.

The aim of this study is to evaluate the effectiveness of using Fibrin glue versus Titanium platelet rich fibrin (T-PRF) as a sole filling material in lateral sinus lifting using with simultaneous implant placement in comparison to a negative control group.


Eligibility criteria: Inclusion Criteria:

* Patients requiring implant placement in the posterior maxilla.
* Tooth extractions at the implant sites were performed at least 4 months before surgery.
* Residual bone height between the alveolar bone crest and the sinus floor is 3-5 mm

Exclusion Criteria:

* Maxillary sinus pathologies (sinusitis, long-standing nasal obstruction).
* Any disease-contraindicating surgery (e.g. uncontrolled diabetes).
* Heavy smokers (smoke greater than or equal 25 cigarettes daily).
* Acute oral infections.
* Untreated periodontal disease (gingival index 2 and 3).
* Poor oral hygiene ( Silness-Löe index (score 2-3) ).
* A history of radiotherapy or chemotherapy of the head and neck region.
* Pregnancy.

Primary outcomes:
measure: change in implant stability
timeFrame: Baseline and 6 months
measure: change in bone density
timeFrame: Baseline and 6 months
measure: change in vertical bone height
timeFrame: Baseline and 6 months
Secondary outcomes:
measure: change in pain intensity
timeFrame: Through 1 week postopertaive
measure: Change in edema score
timeFrame: Through 1 week postopertaive
Other outcomes:
Locations:
city: Alexandria
country: Egypt
facility: Outpatient Clinic of Oral and Maxillofacial Surgery Department, Faculty of Dentistry, Alexandria University, Egypt
state: Azarita
Study officials:
References: