louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03189043: Controlled Crossover Study of AIONX Antimicrobial Surface for the Prevention of Healthcare-associated Infections
Official title: Controlled Crossover Study of AIONX Antimicrobial Surface for the Prevention of Healthcare-associated Infections
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Healthcare Associated Infection
Lead sponsor: Aionx, Inc.
Sponsor class: INDUSTRY
First posted: 2017-06-16
Enrollment: 10000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: This is a controlled open label efficacy study of Aionx antimicrobial surface for the prevention of healthcare-associated infections.

Detailed description: The study is an open label controlled efficacy trial of Aionx patented antimicrobial surface for the prevention of healthcare-associated infections (HAIs). It will take place at Penn State Hershey. Half of the single occupancy rooms of the 5th and 7th floor will be assigned to contain the antimicrobial surface at five locations: bed rails, overbed table, door handles, counter, and arm rests of bedside chair. The remaining rooms will serve as controls. Data on HAIs will be gathered for all the patients admitted to the rooms during the duration of the study. After 45 days the rooms will be flipped so that test rooms become controls and control rooms become test rooms. The duration of the study will be for a minimum of 90 days.

Eligibility criteria: Inclusion Criteria:

* Admission to a single occupancy room in a participating floor at Hershey Medical Center

Exclusion Criteria:

* Refusal to participate in the study.

Primary outcomes:
measure: Healthcare-Associated Infections
timeFrame: 90 days
Secondary outcomes:
measure: 30-day Readmission for infection
timeFrame: 90 days
Other outcomes:
Locations:
Study officials:
affiliation: Milton S. Hershey Medical Center
name: Jose A Stoute, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06405243: Myoinositol, L-arginine and Chromium With Letrozole for Ovulation Induction in Polycystic Ovarian Syndrome Patients
Official title: The Combination of Myoinositol, L-arginine and Chromium With Letrozole for Ovulation Induction in Polycystic Ovarian Syndrome Patients
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE3
Conditions: Polycystic Ovary Syndrome
Keywords: Polycystic Ovary Syndrome
letrazole
myoinositol
L-arginine
Chromium
Lead sponsor: Beni-Suef University
Sponsor class: OTHER
First posted: 2024-05-08
Enrollment: 100
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of the study is to compare and assess the efficacy of combined letrozole with myoinositol, chromium, or L-arginine in infertile women with PCOS. This study will help in the investigation of alternative therapeutic modalities for fertility improvement in polycystic ovarian syndrome

Detailed description: d prospective Study Trial. We will recruit patients diagnosed with PCOS according to Rotterdam criteria of PCOS and who present to outpatient clinics at Beni-Suef University Hospital. Infertile women will be randomized to receive letrozole (2.5 mg for 5 days from 3rd day of patients' menstrual cycle) combination with myoinositol, chromium or L-arginine

Eligibility criteria: Inclusion Criteria:

* Primary or secondary infertility associated with PCOS as defined by the revised Rotterdam criteria
* Normal values of the following laboratory tests: thyroid function, prolactin level, and husband's sperm analysis and hysterosalpingography

Exclusion Criteria:

1. Patients with a history of systemic diseases such as liver, kidney, cardiovascular, diabetes (type I or II) or malignancy.
2. Patients who consumed myoinositol, metformin, SGLT2 or drugs effecting insulin secretion or clomiphene citrate in the previous 2 months.

3. Use of hormonal medications, lipid-lowering agents (statins, etc.), anti-obesity drugs or medications for weight loss in the previous 2 months.

4. Patients with hormonal disorders such as hyperprolactinemia, hypo or hyperthyroidism or Cushing syndrome. 5. Presence of hypersensitivity to any of the study medications.

Primary outcomes:
measure: ovulation
timeFrame: 3 cycles ( 3 months / one month for each cycle)
Secondary outcomes:
Other outcomes:
Locations:
city: Banī Suwayf
country: Egypt
facility: Beni-suef university Hospital
city: Banī Suwayf
country: Egypt
facility: Beni-suef university
Study officials:
References:
Clinical trial NCT00226603: Lyske Trial (Danish) Groin Trial
Official title: Prevention of Groin Injuries in Football Players
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Groin Injuries in Football Players
Keywords: groin injury
football
prevention
traing programme
cluster randomized study
Lead sponsor: Hölmich, Per, M.D.
Sponsor class: INDIV
First posted: 2005-09-27
Enrollment: 1600
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: To examine the effect of a specific training programme towards groin injuries in male footbal players. To evaluate the effect on other football related injuries as well. To examine any possible relations between various possible predictors such as experience, age, hypermobility and others, and the risk of sustaining inujries during football.


Eligibility criteria: Inclusion Criteria:

male adult football players playing in the participating clubs in the study period

-

Exclusion Criteria:

* under 18 years groin injury at the start of the study

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Per Holmich
state: Værløse
Study officials:
affiliation: H:S Copenhagen Trial Unit
name: Christian Gluud, PHD
role: STUDY_CHAIR
References:
Clinical trial NCT03936803: Interval Training Versus Electro Acupuncture on Liver Functions in Patients With Non-alcoholic Fatty Liver Disease
Official title: Interval Training Versus Electro Acupuncture on Liver Functions in Patients With Non-alcoholic Fatty Liver Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Non-Alcoholic Fatty Liver Disease
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2019-05-03
Enrollment: 50
Sex: ALL
Minimum age (years): 30
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: in this study, the investigators compare the effect of interval training exercise and electroacupuncture on liver functions in non-alcoholic fatty liver disease patients

Detailed description: fifty patients suffering from Nonalcoholic fatty liver disease (NAFLD) will be recruited in this study with age ranged from 30-55 years old from both sexes, chosen from internal medicine department at Kasr El Aini hospital and from the outpatient clinic of nutrition and cardiovascular disorders at the faculty of Physical Therapy Cairo University, they were divided in to two groups:Group (1):

Twenty-five patients suffering from Nonalcoholic fatty liver disease (NAFLD), and taking their standard medications In addition to electroacupuncture at points of LR3 (Taichong), LR14 (Qimen), GB 34(Yanglingquan) and ST36 (Zu San Li). Group (2):

Twenty-five patients suffering from Nonalcoholic fatty liver disease(NAFLD) and taking their standard medications in addition to aerobic interval training exercise.Lab investigations of:

Aspartate aminotransferase (AST), Alanine aminotransferase (ALT), Triglycerides (TG) and C-reactive protein (CRP).to judge liver functions

Eligibility criteria: Inclusion Criteria:

1. Sixty patients suffering from Nonalcoholic fatty liver disease (NAFLD).
2. Their age will be ranged from 30-55 years old.
3. Body mass index (30 - 40)
4. All patients are medically stable.

Exclusion Criteria:

* Patients with Hepatitis C \& b
* Acute and chronic significant illnesses that may interfere with actual training, severe ventricular arrhythmia, hemodynamic deterioration or exercise-induced arrhythmia at baseline testing.
* Co-morbidities that limit exercise tolerance (hemoglobin 10 g/dl, a chronic obstructive pulmonary disease with FEV1 50%).
* Hypertension (resting blood pressure \>140/90 mmHg).
* Heart failure, inability to exercise, or drug abuse.
* Pacemakers
* Pregnancy
* Epileptic Seizures
* Cancer

Primary outcomes:
measure: body mass index
timeFrame: about 4 weeks
measure: lab investigations
timeFrame: about 12 weeks
measure: lab investigations
timeFrame: about 14weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: faculty of physical therapy Cairo university
Study officials:
affiliation: Cairo University
name: zahra 63 serry, prof
role: STUDY_DIRECTOR
References:
Clinical trial NCT03195803: Cognitive Intervention in Mild Cognitive Impairment With or Without White Matter Hyperintensities
Official title: Evaluation of Differential Effects of a Computer-based-cognitive Intervention on Cognition Among Elderly With Mild Cognitive Impairment With and Without White Matter Hyperintensities: A Comparative Study.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mild Cognitive Impairment
Lead sponsor: Broca Hospital
Sponsor class: OTHER
First posted: 2017-06-22
Enrollment: 51
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Comparison, non-randomized single blind study
Primary purpose: PREVENTION

Brief summary: This is a non-pharmacological study evaluating the differential effects of a computerized cognitive stimulation program according to the existence or not of white matter hyperintensities in elderly with mild cognitive impairment.

Detailed description: White matter hyperintensities (WMH) are increasingly recognized as a factor determining the heterogeneity of Mild Cognitive Impairment (MCI) and have been associated to executive and processing speed impairment. Cognitive interventions in MCI remain quite limited for these MCI with vascular profile and studies often distinguish patients by clinical subtypes rather than brain profile before an intervention. Considering magnetic resonance imaging (MRI) data, this study investigated the effects of a computer-based cognitive stimulation (CCS) program on MCI with WMH compared to MCI without WMH.

Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of Mild Cognitive Impairment
* With and without white matter hyperintensities
* MRI available or accept to perform one
* No engagement in other cognitive intervention program

Exclusion Criteria:

* Psychiatric and neurological disorders
* History of alcohol or other substance abuse
* Sensory and/or motor deficit affecting the use of a tablet

Primary outcomes:
measure: Rey Auditory Verbal Learning test
timeFrame: Baseline assessment, change from Baseline on Rey Auditory Verbal Learning test at 3 months immediately after intervention and at 3 months follow-up
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Broca University Hospital
name: Anne-Sophie AR RIGAUD, Professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01444443: DiaCon Overnight Closed-Loop Glucose Control Study
Official title: DiaCon Closed-Loop Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 1 Diabetes
Keywords: Type 1 diabetes
Glucose control
Closed-loop
Insulin pump
Glucose sensor
Lead sponsor: Hvidovre University Hospital
Sponsor class: OTHER
Collaborators: name: Technical University of Denmark
name: Novo Nordisk A/S
First posted: 2011-09-30
Enrollment: 12
Sex: ALL
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 objective of this in-clinic study is to test our closed-loop glucose control system in patients with type 1 diabetes.


Eligibility criteria: Inclusion Criteria:

* Age 18-65 years
* Type 1 diabetes duration \> 2 years
* HbA1c \< 8%
* Insulin pump user \> 1 year

Exclusion Criteria:

* Use of medication affecting glucose metabolism
* Pregnancy or nursing

Primary outcomes:
measure: Number of hypoglycemic events
timeFrame: 22:00-07:00
Secondary outcomes:
measure: Time spent in euglycemia (3.9-8.0 mmol/l); mean blood glucose level; LBGI
timeFrame: 22:00-07:00
Other outcomes:
Locations:
city: Hvidovre
country: Denmark
facility: Hvidovre University Hospital
Study officials:
affiliation: Hvidovre University Hospital
name: Signe Schmidt, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00348543: Prophylactic Laser Treatment of Drusen Maculopathy
Official title: Prophylactic Laser Treatment of Drusen Maculopathy in Age-related Macular Degeneration.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Age-related Macular Degeneration
Keywords: age-related macula degeneration
prophylactic laser treatment
exudative complication
Lead sponsor: University Hospital, Linkoeping
Sponsor class: OTHER
First posted: 2006-07-04
Enrollment: 150
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: To study the effect of mild laser treatment on the incidence of exudative complications in soft drusen maculopathy. We hypothesise that mild laser treatment causing a proliferation of the retinal pigment epithelium and enhancing the capacity of clearing drusen material from Bruch's membrane.


Eligibility criteria: Inclusion Criteria:

* \> 55 years of age,
* Soft drusen maculopathy,
* VA 0.8-1.0

Exclusion Criteria:

* VA \<0.8,
* Pigment clumps,
* PED,
* CNV,
* Atrophy,
* Haemorrhage,
* Diabetes retinopathy,
* Sign cataract,
* Glaucoma

Primary outcomes:
measure: Change in visual acuity
Secondary outcomes:
measure: incidence of exudative complications
Other outcomes:
Locations:
city: Linköping
country: Sweden
facility: Dept of Ophthalmology, Linköping University
Study officials:
affiliation: Linkoeping University
name: Christina I Frennesson, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04512443: Clinical Efficacy of Conservative Treatment in Female Patients With Plevic Congestion Syndrome
Official title: Clinical Efficacy of Conservative Treatment in Female Patients With Plevic Congestion Syndrome
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pelvic Congestion Syndrome
Lead sponsor: Interregional Clinical Diagnostic Center, Russia
Sponsor class: OTHER
First posted: 2020-08-13
Enrollment: 83
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: women with Pelvic congestion syndrome

Brief summary: The article presents the results of a randomized, placebo-controlled study of the conservative treatment with Daflon (Detralex) in female patients with Pelvic congestion syndrome .


Eligibility criteria: Inclusion Criteria:

•The presence of pelvic varicose veins verified by transvaginal and transabdominal duplex ultrasound scanning

Exclusion Criteria:

* Severe disease of the gastrointestinal tract or hematopoietic system
* Terminal stage of cardiovascular, respiratory, renal or hepatic failure
* Grade IV malignancy
* Peripheral artery disease (PAD) of the lower extremities, any type of diabetes, or mental disease.
* Pregnant women at any gestational age, women who gave birth less than 12 months ago, and breastfeeding mothers.

Primary outcomes:
measure: Pelvic Varicose Veins Questionnaire
timeFrame: 2 months
Secondary outcomes:
Other outcomes:
Locations:
city: Kazan
country: Russian Federation
facility: Akhmetzianov Rustem
city: Kazan
country: Russian Federation
facility: Roman Bredikhin
Study officials:
References:
Clinical trial NCT00496743: Study of Low-Dose Total Skin Electron Beam Therapy in Mycosis Fungoides
Official title: A Prospective, Open-Label Study on Low-Dose Total Skin Electron Beam Therapy in Mycosis Fungoides
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Mycosis Fungoides
Lead sponsor: Bispebjerg Hospital
Sponsor class: OTHER
First posted: 2007-07-04
Enrollment: 10
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 purpise of this study was to determine the effect of low-dose (4 Gy) total skin electron beam therapy as a second-line treatment of stage IB-II mycosis fungoides.

Detailed description: Current treatment modalities are usually not curative and having treatment options suitable for the long-term control therefore essential. Electron beam therapy is generally applied to the skin in total doses of 30-36 Gy over a 8-10 week period.Due to the potential risk of toxicity including bone marrow supression, no more than 2-3 courses in a life time are generally recommended. In the current study we explored the possibility of using lower radiation doses for total skin electron beam therapy for long-term disease control.

Eligibility criteria: Inclusion Criteria:

* histologically confirmed mycosis fungoides stage I-II with failure to obtain full remission after standard PUVA treatment or relapse within 4 months of PUVA treatment

Exclusion Criteria:

* under 18 years, pregnancy, other somatic diseases with a life expentancy under 1/2 years, psycological disorder preventing the patient to understand the information and cooperate in the treatment

Primary outcomes:
measure: Response rates
measure: Duration of responses
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Bispebjerg Hospital
name: Robert Gniadecki, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06195943: Feasibility, Safety and Acceptability of a Mobile Health Delivered Exercise Training Program in Patients with Nonalcoholic Steatohepatitis
Official title: Feasibility, Safety and Acceptability of a Mobile Health Delivered Exercise Training Program in Patients with Nonalcoholic Steatohepatitis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: NASH - Nonalcoholic Steatohepatitis
NASH
Exercise
Liver
Lead sponsor: Milton S. Hershey Medical Center
Sponsor class: OTHER
First posted: 2024-01-08
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: This study will be a pilot study to evaluate the feasibility, safety and acceptability of Exercise and Liver FITness (EL-FIT), a mHealth exercise training program previously validated in patients with cirrhosis in patients with nonalcoholic steatohepatitis.


Eligibility criteria: Inclusion Criteria:

* Adults age \>18 years
* Evidence of NASH indicated by at least one of the following

  * Liver biopsy with evidence of steatohepatitis (NAS \>=4) within 6 months of the screening interval or;
  * Historical Imaging study (e.g., ultrasound, CT, MRI) with hepatic steatosis and one of the following non-invasive tests within 6 months of the screening interval: i. FIB-4 \>= 1.3 or; ii. NFS \>= -1.44 or; iii. ELF \>= 7.7 or; iv. VCTE kPa \>=8 or; v. ARFI \>=1.3 or; vi. FAST \>= 0.35 or; vii. MRE kPa \>=2.55 or; viii. MAST \> 0.165 or;
* Possession of a smartphone

Exclusion Criteria:

* Active cardiac symptoms precluding participation in vigorous exercise
* Active or recent participation in exercise training program within the last 90 days
* Active or recent weight-loss supplement use within the last 90 days (does not include GLP-1 receptor agonist use)
* Active illicit substance use
* Cancer that is active
* Cirrhosis
* Exercise identified to be unsafe by study PI or EL-FIT mHealth program
* Inability to provide informed consent
* Inability to walk \> 2 blocks
* Institutionalized/prisoner
* Other chronic liver disease (e.g., viral hepatitis)

Primary outcomes:
measure: Number of subjects that complete at least 50% of the exercise sessions
timeFrame: 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Hershey
country: United States
facility: Penn State Hershey Medical Center
state: Pennsylvania
Study officials:
affiliation: Penn State Health
name: Jonathan G Stine, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04672343: Prognostic Impact of the Nutritional Status of Individuals Aged 70 Years and Older With SARS-CoV-2
Official title: IPrognostic Impact of the Nutritional Status of Individuals Aged 70 Years and Older With SARS-CoV-2
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: SARS-CoV-2
Lead sponsor: Centre Hospitalier Universitaire Dijon
Sponsor class: OTHER
First posted: 2020-12-17
Enrollment: 300
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Seniors with CoV-2-RASS

Brief summary: Mortality due to Covid-19 is much higher in the elderly. There are several reasons for the vulnerability of the elderly to the coronavirus: a less efficient immune system, underlying chronic conditions, less protected living conditions. They may also present a poor nutritional state and/or degraded metabolic reserves aggravating an underlying state of frailty. The prevalence of the risk of undernutrition in elderly patients with COVID-19 is high. The evolution of the nutritional status of people aged 70 years or older infected with SARS-Cov-2 is not yet well known. The prognosis of these patients could depend on their nutritional status at the time of the disease. In view of the lack of data, it would be interesting to compare the risk of mortality based on nutritional status in individuals with vs. those without COVID-19.


Eligibility criteria: Inclusion Criteria:

* SARS-CoV-2 test positive (positive PCR test or evocative CT scan) or negative (with clinical suspicion of COVID, negative PCR test and non-evocative CT scan)
* Age ≥ 70 years old
* Hospitalization at Dijon University Hospital
* Person or legal representative has not stated their opposition to inclusion in the study after being informed

Exclusion Criteria:

* Person subject to a measure of judicial safeguard
* Non-affiliated or non-beneficiary of national health insurance

Primary outcomes:
measure: Death
timeFrame: to 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Dijon
country: France
facility: Chu Dijon Bourogne
Study officials:
References: