louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02937610: Percutaneous Endoscopic Gastrostomy in Hands of ORL-HN Surgeon
Official title: Prospective Experience of Percutaneous Endoscopic Gastrostomy Tubes in an Otolaryngologist Service - Safety and Benefits
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Head and Neck Cancer
Percutaneous Endoscopic Gastrostomy
Complication
Lead sponsor: University of Helsinki
Sponsor class: OTHER
First posted: 2016-10-18
Enrollment: 127
Sex: ALL
Minimum age (years): 31
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 127 consecutive head and neck cancer patients, who underwent PEG placement at the Department of ORL - HNS, Helsinki University Hospital, between October 2011 and May 2013.

Brief summary: PEG tubes are commonly used to provide nutritional support to patients with head and neck cancer. PEG insertions are typically carried out by gastroenterologists, but also otorhinolaryngologist - head and neck surgeons perform the procedure in some countries. Prospective studies on PEG tube placements in an ORL - HNS service are lacking. The investigators aim was to prospectively evaluate the preformance of ORL - HN surgeons in PEG tube insertions, and analyze the time gains and cost effectiveness achieved of the independency from other specialities.


Eligibility criteria: Inclusion Criteria:

* head and neck cancer as a underlying disease

Exclusion Criteria:

-

Primary outcomes:
measure: complications
timeFrame: 1 year
measure: mortality
timeFrame: 1 year
Secondary outcomes:
measure: delay
timeFrame: 1 year
Other outcomes:
measure: costs
timeFrame: 1 year
Locations:
Study officials:
affiliation: Otorhinolaryngology - Head and Neck Surgery
name: Johanna Ruohoalho, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06882681: Silymarin Bioavailability Study
Official title: Novel Micellar Formulation of Silymarin with Enhanced Bioavailability in a Double-Blind, Randomized, Crossover Human Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bioavailability and Pharmacokinetics
Keywords: milk thistle
silymarin
LipoMicel
pharmacokinetics
bioavailability
absorption
micelles
Lead sponsor: Isura
Sponsor class: OTHER
First posted: 2025-03-18
Enrollment: 16
Sex: ALL
Minimum age (years): 21
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This study seeks to evaluate and compare the pharmacokinetics of a novel micellar silymarin formulation with that of a standard silymarin formulation.


Eligibility criteria: Inclusion Criteria:

* Male or female aged 21- 65 years
* Healthy, good physical condition
* Voluntary, written, informed consent to participate in the study.

Exclusion Criteria:

* Serious acute or chronic diseases e.g. liver, kidney, or gastrointestinal diseases
* Contraindication or allergies to milk thistle
* Pregnancy or breastfeeding
* Concurrent use of supplements and/or medications
* Participation in another investigational study

Primary outcomes:
measure: AUC: the area under the concentration-time curve
timeFrame: 0 (baseline; pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 12, 24 hours (post-dose)
measure: Cmax: maximum plasma concentration
timeFrame: 0 (baseline; pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 12, 24 hours (post-dose)
measure: Tmax: the time point of maximum plasma concentration
timeFrame: 0 (baseline; pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 12, 24 hours (post-dose)
measure: MRT: Mean residence time
timeFrame: 0 (baseline; pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 12, 24 hours (post-dose)
measure: T1/2: elimination half-life
timeFrame: 0 (baseline; pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 12, 24 hours (post-dose)
Secondary outcomes:
Other outcomes:
Locations:
city: Burnaby
country: Canada
facility: ISURA
state: British Columbia
Study officials:
affiliation: Isura
name: Julia Solnier, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04948281: Joint Infection Following ACL Reconstruction
Official title: The Effects of Joint Infection Following Arthroscopic Single-bundle ACL Reconstruction With Autologous Hamstring: a Retrospective Matched Cohort Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Joint Infection
Lead sponsor: Peking University Third Hospital
Sponsor class: OTHER
First posted: 2021-07-01
Enrollment: 104
Sex: ALL
Minimum age (years): 16
Maximum age (years): 50
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The study population were from 20549 arthroscopic ACL reconstruction surgeries in our institute between January 2002 to December 2017.

Brief summary: This study was conducted to analyze the effect of joint infection on the bone tunnel, graft and articular cartilage following arthroscopic single-bundle anterior cruciate ligament (ACL) reconstruction with autologous hamstring, to summarize the features of MR findings after joint infection, and to correlate these findings with their possible factors.

Detailed description: A retrospective matched cohort study was performed in 26 patients who underwent arthroscopic single-bundle ACL reconstruction with hamstring graft and developed postoperative joint infection in our institute from January 2002 to December 2017. They were matched 1:3 to patients who did not sustain joint infection after ACL reconstruction. MR scan was collected at the time of follow-up. Bone tunnel enlargement at tunnel aperture, midsection and exit of tibial and femoral tunnel was carefully assessed. Graft signal-to-noise quotient (SNQ) on MRI was calculated to evaluate graft maturity. Cartilage morphology was graded using Whole Organ Magnetic Resonance Imaging Score. A generalized linear mixed model was applied to analyze the effect of joint infection on the bone tunnel, graft and articular cartilage.

Eligibility criteria: Inclusion Criteria:

* Age between 16 to 50 years;
* Underwent single-bundle ACL reconstruction with autologous hamstring;
* Had valid follow-up magnetic resonance imaging (MRI) at least 1 year after surgery

Exclusion Criteria:

* Concomitant ligament injury which need surgical repair;
* Delayed onset of postoperative joint infection (\>3 months after surgery).

Primary outcomes:
measure: Tunnel enlargement
timeFrame: 1 year after operation/infection
measure: Graft signal intensity
timeFrame: 1 year after operation/infection
measure: Cartilage morphology
timeFrame: 1 year after operation/infection
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking university third hospital
state: Beijing
Study officials:
affiliation: Peking University Third Hospital
name: yingfang ao, M.D.
role: STUDY_CHAIR
References:
Clinical trial NCT05399381: Traveling-wave Transcranial Electric Stimulation
Official title: Precision Transcranial Electric Stimulation for the Therapy of Cognitive Impairment
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Working Memory
Lead sponsor: University of Minnesota
Sponsor class: OTHER
Collaborators: name: Brain & Behavior Research Foundation
First posted: 2022-06-01
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: This study will assess the impact of traveling wave transcranial alternating current stimulation (tACS) on working memory performance in adults.

Detailed description: Transcranial alternating current stimulation (tACS) can non-invasively alter neuroelectric activity in the brain by applying weak time-varying electric currents via the scalp. Complex patterns of electric brain activity can take the form of traveling waves - spatially coherent brain rhythms that gradually propagate through the neocortex. Traveling waves are crucial for the temporal coordination of informational flow in the brain. Using the novel traveling-wave transcranial alternating current stimulation (tACS) approach, the investigators will explore the effects of frontal-to-parietal and parietal-to-frontal traveling waves on working memory performance and brain electrophysiology in adults.

Eligibility criteria: Inclusion Criteria:

1. Age between 18 and 45 years old.
2. Confident level of English language.

Exclusion Criteria:

1. History or evidence of chronic neurological or mental disorder.
2. Metal or electric implant in the head, neck, or chest area.
3. History of head injuries with loss of consciousness.
4. Any acute or chronic medical condition that requires ongoing pharmacological treatment.
5. Pregnancy or breast-feeding.
6. Alcohol or drug addiction.

Primary outcomes:
measure: Changes in working memory performance
timeFrame: Immediate effect during stimulation
Secondary outcomes:
measure: Changes in reaction time
timeFrame: Immediate effect during stimulation
measure: Changes in electroencephalographic (EEG) connectivity
timeFrame: Five minutes post-stimulation
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
Study officials:
affiliation: University of Minnesota
name: Ivan Alekseichuk, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00524381: Etanercept Treatment in the Early Course of Polymyalgia Rheumatica
Official title: The Effect of Etanercept on the Early Clinical Course of Polymyalgia Rheumatica (Pilot Study)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Polymyalgia Rheumatica
Lead sponsor: Bispebjerg Hospital
Sponsor class: OTHER
First posted: 2007-09-03
Enrollment: 40
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the effect of the tumor necrosis factor alpha (TNF) antagonist, etanercept, on the early clinical course of polymyalgia rheumatica (PMR).

PMR is a common inflammatory disease with an unknown etiology that is characterized by aching, tender, and stiff proximal muscle. Some evidence suggests that TNF plays a central role in the pathophysiology of PMR.

The preferred treatment with glucocorticoids (GCs) is adequate for most patients, but a subset of patients have a more prolonged, relapsing disease course. These patients require treatment with GCs for 1 to 2 years. GC related adverse events are frequent during treatment.


Eligibility criteria: Inclusion Criteria:

* Persons with active polymyalgia rheumatica (patients only).
* Signed informed consent and written authorization.

Exclusion Criteria:

* Other inflammatory conditions than polymyalgia rheumatica, including symptoms of giant cell arteritis, e.g. head aches, jaw claudication and visual disturbances.
* Current malignancy or history of malignancy.
* Neuromuscular conditions.
* Infections with systemic impact.
* Uncontrolled diabetes mellitus.
* Uncontrolled hypertension.
* Current tuberculosis or history of tuberculosis.
* Severe heart failure (NYHA class 3 and 4).
* Current use of glucocorticoids, biological drugs, and immunosuppressive drugs.

Exclusion Criteria (controls):

* Polymyalgia rheumatica.

Primary outcomes:
measure: Polymyalgia rheumatica activity score (PMR-AS)
timeFrame: 14 days
Secondary outcomes:
measure: Plasma concentrations of various cytokines, chemokines, and adipokines
timeFrame: 14 days
measure: Quantitative use of analgesics
timeFrame: 14 days
measure: Insulin sensitivity (HOMA)
timeFrame: 14 days
Other outcomes:
Locations:
city: Copenhagen NV
country: Denmark
facility: Bispebjerg Hospital, Department of Rheumatology
Study officials:
affiliation: Bispebjerg Hospital, Department of Rheumatology
name: Henrik Galbo, Professor
role: STUDY_DIRECTOR
References:
citation: Kreiner FF, Galbo H. Activity of the neuroendocrine axes in patients with polymyalgia rheumatica before and after TNF-alpha blocking etanercept treatment. Arthritis Res Ther. 2012 Aug 15;14(4):R186. doi: 10.1186/ar4017.
citation: Kreiner F, Galbo H. Effect of etanercept in polymyalgia rheumatica: a randomized controlled trial. Arthritis Res Ther. 2010;12(5):R176. doi: 10.1186/ar3140. Epub 2010 Sep 20.
Clinical trial NCT05478681: Home-based Transcranial Direct Current Stimulation (tDCS) for Behavioral Symptoms in Alzheimer's Disease and Related Dementias (ADRD)
Official title: Home-based tDCS for Behavioral Symptoms in Alzheimer's Disease and Related Dementias (ADRD)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Alzheimer Disease
Keywords: depression
anxiety
irritability
apathy
psychosis
tDCS
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
Collaborators: name: Texas Alzheimer's Research and Care Consortium
First posted: 2022-07-28
Enrollment: 20
Sex: ALL
Minimum age (years): 60
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 assess acceptability, and safety of providing tDCS to ADRD patients with behavioral symptoms and to assess the efficacy of tDCS for ADRD-related symptoms, mainly behavioral symptoms.


Eligibility criteria: Inclusion Criteria:

* have ADRD and clinically-meaningful behavioral symptoms
* have a caregiver willing to participate in the study
* can speak and read English
* have stable doses of medications for at least one month

Exclusion Criteria:

* any unstable concurrent medical conditions
* history of brain surgery
* seizure
* intracranial metal implantation
* current alcohol/substance use disorder

Primary outcomes:
measure: Acceptability of the tDCS treatment as assessed by the tDCS acceptability questionnaire
timeFrame: week 2
measure: Acceptability of the tDCS treatment as assessed by the tDCS acceptability questionnaire
timeFrame: week 4
measure: Acceptability of the tDCS treatment as assessed by the tDCS acceptability questionnaire
timeFrame: week 6
measure: Acceptability of the tDCS treatment as assessed by the tDCS acceptability questionnaire
timeFrame: week 12
measure: safety as assessed by the side effects questionnaire
timeFrame: week 2
measure: safety as assessed by the side effects questionnaire
timeFrame: week 4
measure: safety as assessed by the side effects questionnaire
timeFrame: week 6
Secondary outcomes:
measure: Change in dementia-related behavioral symptoms as assessed by the Neuropsychiatric Inventory (NPI-Q) scale
timeFrame: Baseline, week 2, week 4, week 6, 6 weeks post treatment
measure: Change in apathy as assessed by the Brief Dimensional Apathy Scale (b-DAS)
timeFrame: Baseline, Week 6 and Week 12.
measure: Change in depressive symptoms as assessed by the Cornell Scale for Depression in Dementia (CSDD)
timeFrame: Baseline, Week 6 and Week 12.
measure: Change in cognition as evaluated by the Mini-Mental State Examination (MMSE)
timeFrame: Baseline, Week 6 and Week 12.
Other outcomes:
Locations:
city: Houston
country: United States
facility: The University of Texas Health Science Center at Houston
state: Texas
Study officials:
affiliation: The University of Texas Health Science Center, Houston
name: Kendra M Anderson, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04205981: The Effect of Aerobic Exercise in Overweight and Obese Women
Official title: The Effect of Aerobic Exercise on Body Composition, Cardiovascular System and Autonomic Stress Response, and Cognition in Overweight and Obese Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Overweight
Lead sponsor: Lithuanian Sports University
Sponsor class: OTHER
First posted: 2019-12-20
Enrollment: 33
Sex: FEMALE
Minimum age (years): 38
Maximum age (years): 56
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Study design The study was designed as a prospective controlled randomized trial. Participants were randomly assigned to one of two groups. In the experimental group, participants (n = 17) received 8-week aerobic exercise intervention without nutrition modifications. In the control group, participants (n = 16) did not undergo any intervention and were instructed to maintain their regular physical activity and diet regime for 8 weeks.

Experimental measurements: Anthropometric measurements, Measurement of BDNF, Cardiac autonomic responses, Measurement of aerobic fitness, Measurement of cognitive functions.


Eligibility criteria: Inclusion Criteria:

1. obese women (BMI) \> 25 kg/m2;
2. exhibiting weight stability (body weight change \< 2 kg) for at least 2 months prior to enrollment;
3. with a sedentary lifestyle (regular exercise \< 1 h/week);
4. had no medical condition that would affect study results and limit physical activity;
5. not undergoing lactation;
6. who were not pregnant or postmenopausal.

Primary outcomes:
measure: Weight
timeFrame: 8 weeks
measure: Blood brain-derived neurotrophic factor (BDNF)
timeFrame: 8 weeks
measure: Cognitive performance
timeFrame: 8 weeks
measure: Maximal oxygen uptake
timeFrame: 8 weeks
measure: Waist and hip circumference
timeFrame: 8 weeks
measure: Resting blood pressure
timeFrame: 8 weeks
measure: Heart rate variability
timeFrame: 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Kaunas
country: Lithuania
facility: Lithuanian Sports University
Study officials:
References:
Clinical trial NCT00001981: The Treatment and Natural History of Acromegaly
Official title: Acromegaly Treatment and Natural History
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acromegaly
Pituitary Neoplasm
Keywords: Acromegaly
Lead sponsor: National Institutes of Health Clinical Center (CC)
Sponsor class: NIH
First posted: 2000-01-24
Enrollment: 117
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: The study involved patients who were referred to us and had acromegaly.@@@@@@

Brief summary: The purpose of this study is to investigate the treatment and natural history of acromegaly. We have a longstanding interest in acromegaly treatment, and a cohort that has been followed for 30 years, or more in some cases. We will continue to follow patients and recruit new patients for treatment and follow-up. Blood and pituitary tumor tissue (when available through clinical care) will be saved for future analyses related to acromegaly.

Detailed description: The purpose of this study is to investigate the treatment and natural history of acromegaly. We have a longstanding interest in acromegaly treatment, and a cohort that has been followed for 30 years, or more in some cases. We will continue to follow patients and recruit new patients for treatment and follow-up.

Eligibility criteria: * INCLUSION CRITERIA:

Patients will be enrolled who are 18 years of age or over who are referred for care.

Primary outcomes:
measure: resolution of IGF-1 Growth Hormone abnormality
timeFrame: every 6 months &amp; at end of study
Secondary outcomes:
Other outcomes:
Locations:
city: Bethesda
country: United States
facility: National Institutes of Health Clinical Center, 9000 Rockville Pike
state: Maryland
Study officials:
affiliation: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
name: Phillip Gorden, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05777681: Management of Aorto-iliac Infection With BioIntegral Surgical No-React® Bovine Pericardial Xenografts
Official title: Management of Aorto-iliac Infection With BioIntegral Surgical No-React® Bovine Pericardial Xenografts
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Aortic Diseases
Lead sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Sponsor class: OTHER
First posted: 2023-03-21
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All consecutive patients who underwent replacement of an infected aneurysm or graft with a BioIntegral Surgical No-React® bovine pericardial prosthesis at our Institution.

Brief summary: Aortic infections (AIs), including aortic graft infections (AGI) as well as mycotic aortic aneurysms (MAA), are rare. The aim of this study is to present our experience with xenogeneic aortic and aortoiliac reconstructions using the BioIntegral Surgical No-React® bovine pericardial graft.


Eligibility criteria: Inclusion Criteria:

* Aortic infection
* Mycotic Aneurysm
* Aortic Graft Infection

Exclusion Criteria:

* Absence of signs of infection

Primary outcomes:
measure: Early Mortality
timeFrame: 30 days
Secondary outcomes:
Other outcomes:
Locations:
city: Rome
country: Italy
facility: Fondazione Policlinico Universitario A Gemelli IRCCS
Study officials:
References:
Clinical trial NCT06577181: Effect of HCG on Endometrial Preparation in Frozen Embryo Transfer
Official title: Effect of Intramuscular Injection of Human Chorionic Gonadotropins on Endometrial Preparation for Frozen Embryo Transfer
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: IVF
Lead sponsor: Assiut University
Sponsor class: OTHER
Collaborators: name: Banon fertility center
First posted: 2024-08-29
Enrollment: 50
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Reproductive age female

Brief summary: Intramuscular injection of HCG to prepare endometrium for frozen embryo transfer

Detailed description: This study is to compare the effectiveness of intramuscular injections of Human chorionic gonadotropins in preparing the endometrium for frozen embryo transfer compared to the control group who did not receive the injection

Eligibility criteria: Inclusion Criteria:

1. Infertile women being prepared for frozen embryo transfer (FET) in an ART program

   Exclusion Criteria:
   * (1) Use of preimplantation genetic test.
2. History of recurrent spontaneous abortion.
3. Presence of congenital uterine malformations.
4. Use of sequential embryo transfer.

Primary outcomes:
measure: Clinical pregnancy
timeFrame: 2months
Secondary outcomes:
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Assiut university
Study officials:
References:
citation: Eftekhar M, Rahmani E, Eftekhar T. Effect of adding human chorionic gonadotropin to the endometrial preparation protocol in frozen embryo transfer cycles. Int J Fertil Steril. 2012 Oct;6(3):175-8. Epub 2012 Dec 17.