louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03232671: Role of Macrophage Migration Inhibitory Factor (MIF) in Heart Failure
Official title: Role of Macrophage Migration Inhibitory Factor (MIF) in Heart Failure
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Heart Diseases
Lead sponsor: University Hospital, Essen
Sponsor class: OTHER
First posted: 2017-07-28
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All patients presenting with symptoms of heart failure.

Brief summary: Evaluating the additional value of Macrophage Migration Inhibitory factor (MIF) in cardiovascular diseases when assessed in clinical routine.


Eligibility criteria: Inclusion Criteria:

All patients presenting with symptoms of heart failure to the West-German Heart and Vascular Center according to the definition of the ESC 2016.

* Patients fulfilling criteria for the diagnosis of HFrEF
* Patients fulfilling criteria for the diagnosis of HFpEF
* Patients fulfilling criteria for the diagnosis of HFmrEF
* Patients presenting with dyspnea according to the NYHA classification I-IV, elevated BNP/NT-proBNP levels and echocardiographic findings of heart failure.

Exclusion Criteria:

* Age \< 18 years
* Patients with symptoms of heart failure without fulfilling the criteria of the ESC guidelines 2016
* Denial to participate

Primary outcomes:
measure: 180 days mortality
timeFrame: 180 days
Secondary outcomes:
Other outcomes:
Locations:
city: Essen
country: Germany
facility: University Hospital of Essen
state: NRW
Study officials:
affiliation: University Hospital of Essen, Department of Cardiology and Vascular medicine
name: Peter Lüdike, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Luedike P, Alatzides G, Papathanasiou M, Heisler M, Pohl J, Lehmann N, Rassaf T. Predictive potential of macrophage migration inhibitory factor (MIF) in patients with heart failure with preserved ejection fraction (HFpEF). Eur J Med Res. 2018 May 4;23(1):22. doi: 10.1186/s40001-018-0321-1.
Clinical trial NCT01703871: Music During Diagnostic Hysteroscopy
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Pain
Anxiety
Tolerability
Lead sponsor: Campus Bio-Medico University
Sponsor class: OTHER
First posted: 2012-10-11
Enrollment: 200
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: primary care clinic

Brief summary: Office Hysteroscopy is associated with a level of anxiety that could condition tolerability of the procedure by the patient.

The aim of this study is to evaluate the impact of music on anxiety state, expected and received pain by patients during office hysteroscopy.


Eligibility criteria: Inclusion Criteria:

* Patients candidates for office hysteroscopy in menopausal status or in childbearing age

Exclusion Criteria:

* Previous diagnostic hysteroscopy and/or RCU
* Current or recent pelvic Inflammation
* Invasive cervix cancer
* Ongoing pregnancy

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03068871: A Comparison of Two Psycho-educational Group Interventions for Tinnitus Patients
Official title: A Comparison of Two Psycho-educational Group Interventions for Tinnitus Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tinnitus
Lead sponsor: Tel-Aviv Sourasky Medical Center
Sponsor class: OTHER_GOV
First posted: 2017-03-03
Enrollment: 45
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: participants will be randomized into one of three groups: 3-session CET intervention, 3-session ACT intervention, or Waiting List group. Each weekly session will last up to 2 hours and 10 participants will be assigned to each group. There will be two cohorts, with 30 participants in each cohort. The Waiting List group will receive the CET intervention after the groups have completed theirs.


Eligibility criteria: Inclusion Criteria:

* Tinnitus lasting more than 3 months
* Hebrew speaking
* Use hearing aids if needed
* Signed informed consent

Exclusion Criteria:

* None

Primary outcomes:
measure: COPE
timeFrame: Before the intervention (T1) and at the end of intervention (T2-4 weeks after T1), 1 month after end of intervention (T3)
Secondary outcomes:
Other outcomes:
Locations:
city: Tel-Aviv
country: Israel
facility: Sourasky Medical Centre
Study officials:
References:
Clinical trial NCT02971371: The Role of MNS in Improving Motor Performance
Official title: The Role of Mirror Neuron System in Improving Motor Performance by Using Virtual Reality, as Revealed by EEG: a Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Lead sponsor: IRCCS Centro Neurolesi Bonino Pulejo
Sponsor class: OTHER
First posted: 2016-11-22
Enrollment: 24
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Many studies have demonstrated the usefulness of repetitive task practice by using robotic devices, including Lokomat, for the treatment of lower limb paresis. Virtual reality (VR) has proved to be a valuable tool to improve neurorehabilitation training. Our pilot randomized clinical trial aimed at evaluating the correlation between the modifications of brain oscillations during a VR neurorehabilitative training of gait and the motor function recovery in patients with chronic stroke.

Twenty-four patients suffering from a first unilateral ischemic stroke in the chronic phase were randomized into two groups. One group performed 40 sessions of Lokomat with VR (RAGT+VR) whereas the other group underwent Lokomat without VR (RAGT-VR). Outcomes (clinical, kinematic, and event-related synchronization, ERS, and desynchronization, ERD, at the EEG) were measured before and after the robotic intervention.

The robotic-based rehabilitation combined with VR could be associated with improvements in several measurements of lower limb function, gait, and balance in patient with chronic hemiparesis. Moreover, ERS/ERD analysis can be proposed as a tool to monitor motor performance and to develop non-invasive brain-computer interfaces controlling robotic devices.


Eligibility criteria: Inclusion Criteria:

* Age ≥55 years
* A first-ever ischemic supra-tentorial stroke (confirmed by MRI scan) at least 6 months before their enrollment;
* An unilateral hemiparesis, with a Muscle Research Council -MCR- score ≤3
* Ability to follow verbal instructions, with a Mini-Mental State Examination (MMSE) \>24
* A mild to moderate spasticity according to a Modified Ashworth Scale (MAS) ≤2
* No severe bone or joint disease
* No history of concomitant neurodegenerative diseases or brain surgery.

Exclusion Criteria:

* Severe cognitive and behavioral impairments
* Severe osteoporosis and previous bone fractures

Primary outcomes:
measure: gait evaluated by Rivermead Mobility Index (RMI)
timeFrame: Six months
Secondary outcomes:
measure: Spasticity evaluated by Modified Ashworth Scale (MAS)
timeFrame: Six months
Other outcomes:
Locations:
Study officials:
References:
citation: Calabro RS, Naro A, Russo M, Leo A, De Luca R, Balletta T, Buda A, La Rosa G, Bramanti A, Bramanti P. The role of virtual reality in improving motor performance as revealed by EEG: a randomized clinical trial. J Neuroeng Rehabil. 2017 Jun 7;14(1):53. doi: 10.1186/s12984-017-0268-4.
Clinical trial NCT00986271: Extravascular Lung Water Index in Severe Sepsis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Severe Sepsis
Keywords: severe sepsis, intensive care units
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
First posted: 2009-09-29
Enrollment: 67
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: To investigate whether extravascular lung water index (EVLI) is an independent predictor for multiorgan dysfunction syndrome (MODS) in patients with severe sepsis and to determine if increased EVLI may serve as an predictor for MODS and mortality in those patients.


Eligibility criteria: Inclusion Criteria:

* All enrolled patients were recruited consecutively on the day of MICU admission and within 24 hours of the diagnosis of severe sepsis.

Exclusion Criteria:

* Pregnancy,
* Age less than 18 years old, and
* Uncontrolled malignancy.

Primary outcomes:
measure: Developement of MODS (multiorgan dysfunction syndrome) and mortality
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01289171: Acquired Epidermodysplasia Verruciformis (EV) Syndrome in HIV-infected Pediatric Patients
Official title: Acquired Epidermodysplasia Verruciformis (EV) Syndrome in HIV-infected Pediatric Patients: Prospective Treatment Trial With Topical Glycolic Acid and HPV Genotype Characterization
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Flat Warts
HIV
Keywords: The efficacy, tolerability and safety of 15% glycolic acid lotion for treatment of diffuse flat warts among HIV+ children were investigated
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
Collaborators: name: NeoStrata Company, Inc.
name: Penn Center for AIDS Research (CFAR)
First posted: 2011-02-03
Enrollment: 38
Sex: ALL
Minimum age (years): 7
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Many human immunodeficiency virus (HIV)-positive children are afflicted with diffuse flat warts that have been recalcitrant to multiple treatments.The aim of this prospective study was to evaluate the efficacy, safety and tolerability of 15% glycolic acid lotion (NeoStrata) for treatment of flat warts in HIV-positive children in Botswana. Additionally, the investigators characterized the flat warts in this population, including Human Papillomavirus (HPV) type(s) and degree of immunosuppression within the patients.


Eligibility criteria: Inclusion Criteria:

* Male or female HIV-positive patients 7 years of age or older with at least 15 flat warts, diagnosed clinically by one dermatologist (RLM), on the face and/or dorsal hands were included in the study.

Exclusion Criteria:

* Key exclusion criteria included current use of potential wart treatments or other topical OTC products on the affected area(s).

Primary outcomes:
measure: Treatment efficacy of 15% glycolic acid lotion for flat warts
timeFrame: Patients were evaluated every two weeks for eight weeks and monthly for the next eight weeks, for a total monitoring period of 16 weeks.
measure: Safety and tolerability of 15% glycolic acid lotion for flat warts
timeFrame: Patients were evaluated every two weeks for eight weeks and monthly for the next eight weeks, for a total monitoring period of 16 weeks.
Secondary outcomes:
measure: HPV typing in EV-like flat warts
timeFrame: Biopsies were taken at the first visit, and the HPV typing was performed on all samples after the 16 week monitoring period was complete.
Other outcomes:
Locations:
city: Gaborone
country: Botswana
facility: Princess Marina Hospital
Study officials:
References:
Clinical trial NCT02396771: Effect of Uterine Massage Versus Sustained Uterine Compression on Blood Loss After Vaginal Delivery
Official title: Effect of Uterine Massage Versus Sustained Uterine Compression on Blood Loss and Maternal Pain After Vaginal Delivery: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postpartum Hemorrhage
Keywords: Uterine
Massage
Compression
Lead sponsor: American University of Beirut Medical Center
Sponsor class: OTHER
First posted: 2015-03-24
Enrollment: 445
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to compare trans-abdominal uterine massage to sustained uterine compression after vaginal delivery with respect to blood loss and maternal pain. It is a randomized controlled trial that will be conducted at the American University of Beirut Medical Center - Delivery Suite.

Detailed description: Women allocated to either the massage or compression group will be given 10 units of oxytocin intramuscularly immediately after delivery of the shoulder and controlled cord traction will be performed to assist placental delivery. The umbilical cord will be clamped and cut approximately 1 minute after delivery of the baby. The uterine fundus will be rubbed and blood clots expelled as quickly as possible after delivery of the placenta.

Eligibility criteria: Inclusion Criteria:

* Women giving birth vaginally, aged between 20 and 40 years, with a singleton pregnancy, gestational age of 36 or more weeks, and with fewer than or equal to three previous childbirths.

Exclusion Criteria:

* Exclusion criteria include multiple gestation, fetal malpresentation, the third stage of labor lasting more than 30 minutes, a previous cesarean delivery, chorioamnionitis, three or more previous induced abortions, preeclampsia, fetal death, polyhydramnios, hemoglobin of 9 g/L or less before delivery, coagulopathy, on magnesium sulfate infusion, abruptio placentae and having an abdominal wall too thick to palpate the fundus of the uterus or to perform uterine massage or compressions after delivery.

Primary outcomes:
measure: Incidence of blood loss of 500 mL or more
timeFrame: 2 years
Secondary outcomes:
measure: Maternal pain
timeFrame: 2 years
measure: Change in hemoglobin as a measure of blood loss
timeFrame: 2 years
measure: Use of therapeutic uterotonics
timeFrame: 2 years
measure: Use of balloon or surgical procedures for postpartum hemorrhage
timeFrame: 2 years
measure: Need for blood transfusion and hospital stay
timeFrame: 2 years
Other outcomes:
Locations:
city: Beirut
country: Lebanon
facility: American University of Beirut Medical Center
Study officials:
affiliation: AUBMC
name: Labib M Ghulmiyyah, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01898871: Effectiveness of Nutritional Products to Treat Moderate Acute Malnutrition
Official title: Using Indigenous Foods to Reduce Malnutrition in Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Wasting
Moderate Acute Malnutrition
Lead sponsor: Centre for Food and Nutrition Research, Yaounde
Sponsor class: OTHER_GOV
Collaborators: name: International Atomic Energy Agency
First posted: 2013-07-12
Enrollment: 81
Sex: ALL
Minimum age (years): 6
Maximum age (years): 59
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether an improved corn-soya blend (CSB+) and a new formulated ready-to-use supplementary food (RUSF) are effective in the treatment of moderate acute malnutrition in children.

Detailed description: Assuming the availability of some food in the household, the caregivers were instructed on how best to use the food they have and the quantity of supplementary food distributed was calculated to provide about 50% of child energy requirement.

Eligibility criteria: Inclusion Criteria:

* Children aged 6-59 month
* Weight-for-height between -3 and -2 z-scores without edema
* Good appetite
* Stable clinical conditions

Exclusion Criteria:

* Weight-for-Height Z-score \< -3
* Presence of bilateral pitting edema
* Unstable clinical conditions
* Not showing appetite

Primary outcomes:
measure: Recovery rate of the children receiving CSB+ or RUSF
timeFrame: 56 days
Secondary outcomes:
Other outcomes:
Locations:
city: Evodoula
country: Cameroon
facility: Evodoula Health District
city: Yaounde
country: Cameroon
facility: Biyem Assi District Centre
Study officials:
affiliation: Centre for Food and Nutrition Research, IMPM
name: Gabriel Medoua Nama, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00916071: Association Between Attention Deficit Hyperactivity Disorder and Bulimia Nervosa in Outpatients With Eating Disorders
Official title: Association Between Attention Deficit Hyperactivity Disorder and Bulimia Nervosa in Outpatients With Eating Disorders
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bulimia Nervosa
Eating Disorders
ADHD
Keywords: Bulimia Nervosa
Eating Disorder NOS
Attention Deficit Hyperactivity Disorder
ADHD
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: The Hilda and Preston Davis Foundation
First posted: 2009-06-09
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Male and female outpatients between, and including, 18 and 55 years of age with a history of eating disorder diagnosis.

Brief summary: To understand whether a relationship exists between eating disorders and ADHD, we seek to clarify the prevalence of ADHD in individuals with eating disorders. To this end, we will estimate the prevalence of ADHD, and other neuropsychiatric disorders, in outpatients with history of an eating disorder diagnosis. Secondarily, we will identify patterns of cognitive deficits in outpatients with history of an eating disorder diagnosis. We will also examine whether ADHD in this population is associated with functional and familial correlates associated with ADHD.


Eligibility criteria: Inclusion Criteria:

* Male and female outpatients between, and including, 18 and 55 years of age with a history of eating disorder diagnosis.

Exclusion Criteria:

* Any clinically unstable psychiatric conditions such as: acute psychosis, acute panic, acute obsessive compulsive disorder, acute mania, acute suicidality, acute substance use disorders (alcohol or drugs), and sociopathy.
* Any metabolic, neurological, hepatic, renal, cardiovascular, hematological, opthalmic, or endocrine disease that would confound ability to participate in valid assessments.
* Mental retardation (IQ \<75).
* Organic brain disorders.
* Non-English speaking subjects will not be allowed into the study because the assessment instruments are unavailable and have not been adequately standardized in other languages.

Primary outcomes:
measure: We will identify the lifetime rate of mental health conditions using structured clinical interviews in subjects with a lifetime history of eating disorders and compare the rate of these conditions to that of non-ED control subjects.
timeFrame: 1 time
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Massachusetts General Hospital
name: Craig Surman, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05449171: High Molecular Weight Hyaluronic Acid, α-lipoic Acid, Magnesium, Vitamin B6 and Vitamin D, in the Prevention of Spontaneous Abortion
Official title: Efficacy of the Association of Hyaluronic Acid With High Molecular Weight, α-lipoic Acid (ALA), Magnesium, Vitamin B6 and Vitamin D, in the Prevention of Spontaneous Abortion in Patients at Risk
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Abortion, Spontaneous
Lead sponsor: Lo.Li.Pharma s.r.l
Sponsor class: INDUSTRY
First posted: 2022-07-08
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The study aims to verify if the association of high molecular weight hyaluronic acid, α-lipoic acid (ALA), magnesium, vitamin B6 and vitamin D, reduces the risk of miscarriage in patients at risk.


Eligibility criteria: Inclusion Criteria:

* two or more previous spontaneous first trimester abortions without apparent risk factors (idiopathic polyabortion)
* Endocrinopathies
* Autoimmune diseases
* Thrombophililic or coagulation diseases

Exclusion Criteria:

* Multiple pregnancies
* Presence of genetic abnormalities of one or both partners leading to increased risk of fetal aneuploidies
* Presence of Mullerian abnormalities in the uterus
* Symptoms present at recruitment such as pelvic pain or metrorrhagia

Primary outcomes:
measure: Incidence of metrorrhagia and/or pelvic pain in the first trimester of gestation.
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Napoli
country: Italy
facility: Dipartimento di Neuroscienze e Scienze riproduttive ed odontostomatologiche
Study officials:
References:
Clinical trial NCT04860271: Manual Acupuncture Using Acupuncture Needle vs Press Needle for COVID-19 Healthcare Anxiety
Official title: Comparison of Manual Acupuncture Effectivity Using Filiform Needles and Press Tack Needle for Healthcare Worker's Anxiety During COVID-19 Outbreak: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anxiety
Keywords: acupuncture
press needle
anxiety
Lead sponsor: Indonesia University
Sponsor class: OTHER
First posted: 2021-04-26
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study would like to compare manual acupunture treatment for anxiety in COVID Health workers population in Cipto Mangunkusumo Hospital using filiform needles and press needle.

Detailed description: This study wanted to know would press needle be having better outcome for anxiety treatment, compared with filiform needles, because press needle taken home and could be manipulated as needed at home, unlike filiform needle where an acupuncturist must be available to do the treatment. Furthermore, the press needle needed to be changed once within 5 days, that is 2-3 times in week. So we hope to have better acupuncture option (in effectivity and timewise) for COVID healthcare workers anxiety treatment. There are no study to compare the usage of the two types of needles for anxiety treatment to date.

Eligibility criteria: Inclusion Criteria:

* COVID-19 health workers.
* Rapid test COVID-19 t or PCR swab non reactive within 7 days before intervention
* HAM-A score below 25
* Could still do daily activities
* Willing to enroll this study and sign the informed consent
* Willing to comply with the study procedure

Exclusion Criteria:

* Contraindicated for acupuncture : having medical emergencies, pregnancy, blood clotting issue, uncontrolled diabetic mellitus, fever.
* Having acupunture treatment within 7 days prior to study intervention
* Having tumor or infection at the pucture site
* Cognitive or consciouseness impairment
* Having anxiety therapy with a psychiatrist

Primary outcomes:
measure: Hamilton Anxiety Scale
timeFrame: two weeks
measure: Short-Form 36
timeFrame: two weeks
Secondary outcomes:
measure: Heart Rate Variability
timeFrame: two weeks
Other outcomes:
Locations:
city: Jakarta
country: Indonesia
facility: Cipto Mangunkusumo Hospital
state: Jakarta Pusat
Study officials:
affiliation: Faculty of Medicine, University of Indonesia
name: Irma Nareswari, dr. Sp.Ak
role: PRINCIPAL_INVESTIGATOR
References: