louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05224674: Comparative Effects of Focused and Radial Shock-Wave Therapies in Hip Osteoarthritis.
Official title: Comparative Effects of Focused (Large Focused) and Radial (Controlled Unfocused) Shock-Wave Therapies in Hip Osteoarthritis.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hip Osteoarthritis
Lead sponsor: Yuzuncu Yıl University
Sponsor class: OTHER
First posted: 2022-02-04
Enrollment: 150
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: There is no scientific study in the literature regarding the use of shock wave therapy in hip osteoarthritis. In this study, we aim to investigate both the effectiveness of ESWT and which type of ESWT can be more effective in hip osteoarthritis.


Eligibility criteria: Inclusion Criteria:

* unilateral or bilateral hip osteoarthritis

Exclusion Criteria:

* other disorders that are contraindications for shockwave therapy, not have received ESWT treatment before

Primary outcomes:
measure: Visual Analogue Scale (VAS)
timeFrame: at baseline.
measure: Visual Analogue Scale (VAS)
timeFrame: 4 weeks after baseline.
measure: Visual Analogue Scale (VAS)
timeFrame: 8 weeks after baseline.
Secondary outcomes:
measure: Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
timeFrame: at baseline.
measure: Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
timeFrame: 4 weeks after baseline.
measure: Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
timeFrame: 8 weeks after baseline.
Other outcomes:
Locations:
city: Van
country: Turkey
facility: Volkan Şah
Study officials:
affiliation: Yüzüncü Yıl Üniversitesi Tıp Fakültesi
name: Volkan Şah
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00523874: Recurrence of Acute Alcoholic Pancreatitis
Official title: Recurrence of Acute Alcoholic Pancreatitis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Recurrent Acute Pancreatitis
Lead sponsor: Tampere University
Sponsor class: OTHER
First posted: 2007-09-03
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: DEFINED_POPULATION
Time perspective: PROSPECTIVE

Brief summary: Previously our retrospective study showed that almost half of the patients with acute alcoholic pancreatitis had a recurrent attack in the long-term, mild pancreatitis and young age being risk factors for recurrence. The aim of this prospective follow-up study was aimed to find out the risk factors in detail.

Detailed description: Patients admitted to Tampere University Hospital for first acute alcoholic pancreatitis were included. The diagnostic criteria for acute pancreatitis were epigastric pain, serum amylase \> 3 x upper normal range, elevated serum CRP and signs of acute pancreatitis in imaging. Other etiologies were excluded. Alcohol consumption and dependency were detected. Serum and fecal markers of the endocrine and exocrine function and secretin stimulated MRCP were studied. The patients were followed median 38 (25 - 61) months for the recurrences and had a follow up visit at two years to investigate trends in the alcohol consumption.

Eligibility criteria: Inclusion Criteria:

* Patients who survived their first acute alcoholic pancreatitis. The diagnostic criteria for acute pancreatitis were epigastric pain, serum amylase \> 3 x upper normal range, elevated serum CRP and signs of acute pancreatitis in imaging. Other etiologies were excluded.
* High alcohol consumption was detected

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Tampere
country: Finland
facility: Tampere University Hospital
Study officials:
affiliation: Tampere University Hospital
name: Isto Nordback, MD,dos
role: STUDY_DIRECTOR
References:
Clinical trial NCT03694574: Emotion Regulation in Trait Schizotypy
Official title: Emotion Regulation in Individuals With High and Low Trait Schizotypy. A Randomized Controlled Trial Comparing Suppression and Reappraisal
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Trait Schizotypy
Lead sponsor: Danube University Krems
Sponsor class: OTHER
Collaborators: name: University of Vienna
First posted: 2018-10-03
Enrollment: 131
Sex: ALL
Minimum age (years): 18
Maximum age (years): 58
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Our aim is to compare state anger and state emotion regulation strategies in healthy individuals with high trait schizotypy and to look at differences of induced anger, negative emotions, decrease of positive emotions and aggressive behaviour after anger induction. Our further aim is to compare conditions where an instruction to suppress or reappraise emotions is given with a control condition with no instruction.


Eligibility criteria: Inclusion Criteria:

* age between 18 and 58 years,
* good command of German language

Exclusion Criteria:

* present or past psychiatric or neurological illness,
* ongoing treatment with psychiatric drugs,
* constant consume of heroin or hallucinogenic drugs,
* alcohol dependence,
* cannabis consume two weeks before testing.

Primary outcomes:
measure: state anger
timeFrame: 3 minutes
measure: state negative emotions
timeFrame: 3 minutes
measure: state positive emotions
timeFrame: 3 minutes
measure: aggressive behavior
timeFrame: 3 minutes
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Klein, C., Andresen, B., & Jahn, T. (1997). Erfassung der schizotypen Persönlichkeit nach DSM-III-R: Psychometrische Eigenschaften einer autorisierten deutschsprachigen Übersetzung des
citation: Krohne, H. W., Egloff, B., Kohlmann, C. W., & Tausch, A. (1996). Untersuchung mit einer deutschen Form der Positive and Negative Affect Schedule (PANAS). Diagnostica, 42, 139-156.
citation: Lieberman, J. D., Solomon, S., Greenberg, J. & McGregor, H. A. (1999). A hot new way to measure aggression: hot sauce allocation, Aggressive Behavior, 25, 331-348
citation: Schwenkmetzger, P., Hodapp, V., & Spielberger, C. D. (1992). Das State-Trait-Ärgerausdrucks-Inventar (STAXI). Bern: Huber.
citation: Szasz PL, Szentagotai A, Hofmann SG. The effect of emotion regulation strategies on anger. Behav Res Ther. 2011 Feb;49(2):114-9. doi: 10.1016/j.brat.2010.11.011. Epub 2010 Dec 9.
Clinical trial NCT01897974: Revisiting Survey Investigating Why Patients Are Not Receiving Home Anti-convulsant Medication Prior to Surgery/or Procedure Involving General Anesthesia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Seizures
Lead sponsor: Nationwide Children's Hospital
Sponsor class: OTHER
First posted: 2013-07-12
Enrollment: 300
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who are taking anti-seizure medications.

Brief summary: Children with seizure disorder face unique challenges during the perioperative period. Fasting, sleep-deprivation, and missed doses of medications while patients are required to have nothing per mouth (NPO) are a few factors that decrease the seizure threshold. The incidence of seizures in this population is unknown but correlated with patient's underlying condition and missed doses of anti-convulsant. Previous work has determined this is not a unique problem.

The investigators initially found compliance extremely poor at 60%. The investigators have made improvement to about 80% compliance through various interventions: education of nursing, availability of anticonvulsant intravenous dosing alternatives, and re-wording the hospital NPO policy. The investigators feel that a new, more focused, survey will help identify, perioperative reasons for non-compliance on part of the parents. This information will be utilized to guide further interventions aimed at improving compliance.


Eligibility criteria: Inclusion Criteria:

* We plan to include all children 0-18 years of age on anticonvulsant(s) for seizure disorder.

Exclusion Criteria:

* None.

Primary outcomes:
measure: Anticonvuslant compliance
timeFrame: 1 Day
Secondary outcomes:
Other outcomes:
Locations:
city: Columbus
country: United States
facility: Nationwide Children's Hospital
state: Ohio
Study officials:
References:
Clinical trial NCT04793074: Transforming Nanoparticle Dressing For Management of Chronic Venous Ulcers
Official title: Transforming Nanoparticle Dressing For Management of Chronic Venous Ulcers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Chronic Venous Hypertension With Ulcer
Lead sponsor: Egyptian Biomedical Research Network
Sponsor class: NETWORK
First posted: 2021-03-11
Enrollment: 60
Sex: ALL
Minimum age (years): 30
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The present randomized controlled study aims to evaluate the role of transforming nanoparticle dressing n management of chronic venous ulcers.

Detailed description: The present randomized controlled study was conducted at Helwan University Hospitals, Cairo, Egypt. The study protocol was approved by the local ethical committee and all patients gave informed consent before enrollment.

The study included 60 patients with CVU. Patients were diagnosed on the basis of clinical findings and vascular Doppler ultrasonography. Exclusion criteria were associated infection and associated ulcers of other etiologies. Patients randomization was achieved using computer generated numbers and sealed envelope technique. Randomization and patients' allocation to the study interventions was performed by an independent researcher who wasn't aware of the study interventions and outcome.

Upon recruitment, patients were subjected to careful history taking, thorough clinical examination, standard laboratory investigations and vascular ultrasound examination. The recorded parameters included demographic data (age, sex and body mass index), associated morbidities, duration and size of CVU and history of previous interventions.

After randomization, patients in the treatment group (n=30) had transforming nanoparticle dressing while the control group (n=30) received conventional compression dressing. Before applications of both dressings, the wound area was thoroughly cleaned. In the treatment group, the dressing powder was applied as a thin layer to the ulcer surface. Any excess powder surrounding the ulcer area was removed. In both groups, a secondary protective gauze dressing was applied. Patients were follow up at weekly intervals until complete healing occurs.

The primary end-point in the present study is the time to complete healing. The secondary end-point the rate of healing (percent of reduction in ulcer area).

Eligibility criteria: Inclusion Criteria:

* Chronic venous ulcers.

Exclusion Criteria:

- Associated infection and associated ulcers of other etiologies.

Primary outcomes:
measure: Time to complete healing (weeks)
timeFrame: 16 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Helwan
country: Egypt
facility: Helwan University
Study officials:
affiliation: Helwan University
name: Barakat Abdelreheem
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02122874: Percutaneous Electric Neurostimulation of Dermatome T7 Improves Glycemic Profile in Obese and Typo 2 Diabetic Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Diabetes Mellitus Type 2 in Obese
Type 2 Diabetes Mellitus With Features of Insulin Resistance
Keywords: Percutaneous neurostimulation; dermatome T7, type 2 diabetes
Lead sponsor: Hospital General Universitario Elche
Sponsor class: OTHER
First posted: 2014-04-25
Enrollment: 60
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: Percutaneous neurostimulation of dermatome T7 increases Insulin segregation by the apancreas and improves glycemic profile in diabetic patients


Eligibility criteria: Inclusion Criteria:

* BMI\>30 Kg/m2
* Type 2 diabetes mellitus
* Treatment with Metformin

Exclusion Criteria:

* Under insulin treatment
* Endocrinological disorders causing diabetes mellitus

Primary outcomes:
measure: Serum glucose levels (mg/dl)
timeFrame: Baseline and 12 weeks after beginning the therapy
Secondary outcomes:
measure: Homeostasis model assessment (HOMA)
timeFrame: Baseline and 12 weeks after beginning the therapy
Other outcomes:
Locations:
city: Elche
country: Spain
facility: General Hospital Elche
state: Alicante
Study officials:
References:
Clinical trial NCT04101474: Role Of Ketamine in Treatment-Resistant Major Depressive Disorder And Its Effect on Suicidality
Official title: Role Of Ketamine in Treatment-Resistant Major Depressive Disorder And Its Effect on Suicidality
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Treatment Resistant Depression
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2019-09-24
Enrollment: 36
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: In this study we will assess the effect of Ketamine infusion on depressive symptoms and in particular its effect on Suicidal behavior, ideation and thoughts in patients with treatment- resistant MDD.

Detailed description: A Twice repetition of IV infusion of 0.5 mg/kg of ketamine produces an antidepressant response in individuals with treatment-resistant MDD

The work aims to:

1. To assess the onset of action and degree of improvement and the duration of antidepressant effect of ketamine in a sample of patients with treatment -resistant major depressive disorder.
2. To find out whether the onset of Ketamine antidepressant effect is associated with an improvement of suicidality in those patients.

Eligibility criteria: Inclusion Criteria:

1. Patients fulfilling diagnostic criteria of treatment-resistant MDD.
2. Presence of suicidal risk.
3. No comorbid medical or neurological conditions.
4. Age above 18 years old.
5. Both gender.
6. Informed written consent from the patient or his legitimate.

Exclusion Criteria:

1. Presence of perceptual disturbance.
2. History of sensitivity to ketamine.
3. Refusal to participate in the study.

Primary outcomes:
measure: Role of Ketamine as Antidepressant
timeFrame: 1 year
measure: Effect of Ketamine on Suicidality
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Assiut university
Study officials:
References:
Clinical trial NCT01322074: Systemic Inflammation Versus Acute Pain in Total Knee Arthroplasty (TKA)
Official title: The Relation Between Systemic Inflammatory Markers and Acute Pain in TKA
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Other Acute Postoperative Pain
Systemic Inflammatory Response Syndrome
Keywords: Acute postoperative pain
systemic inflammation
CRP
IL6
Lead sponsor: Hvidovre University Hospital
Sponsor class: OTHER
First posted: 2011-03-24
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients operated with total knee arthroplasty

Brief summary: In this study we evaluate if there is a correlation between acute pain and systemic inflammatory markers after total Knee Arthroplasty (TKA).

Detailed description: The correlation between acute pain and systemic inflammatory markers after total Knee Arthroplasty (TKA) is evaluated.

Level of systemic inflammatory markers (CRP and IL6) are measured preoperatively and 4 and 24 hours postoperatively. These measurements are correlated to postoperative pain (a detailed assessment of pain at rest and during ambulation).

We pole blood-samples collected prospectively (from two data set)

Eligibility criteria: Inclusion Criteria:

* Elective unilateral primary total knee arthroplasty
* Able to speak and understand danish
* Able to give informed consent

Exclusion Criteria:

* Alcohol or medical abuse
* Allergies to local anesthetics or methylprednisolone
* Age \< 18 years old
* Daily use of strong opioids or glucocorticoids
* Pregnancy or breastfeeding (fertile women)
* Bilateral / revision arthroplasty
* Dementia or other cognitive dysfunction
* Diabetic neuropathy, rheumatoid arthritis, and neurologic or psychiatric diseases potentially influencing pain perception

Primary outcomes:
measure: Systemic inflammation vs. pain
timeFrame: 1 week
Secondary outcomes:
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Dep. of Anesthsiology, Hvidovre University Hospital
state: Hvidovre
Study officials:
References:
Clinical trial NCT00781274: Efficacy and Safety of MP-424, Peginterferon Alfa-2b and Ribavirin in Chronic Hepatitis C Who Have Not Achieved an Undetectable HCV RNA Level With Previous Interferon Based Therapy
Official title: A Phase 3 Study of MP-424 in Combination With Peginterferon Alfa-2b and Ribavirin (RBV) in Subjects With (Genotype 1) Hepatitis C Who Did Not Respond to Previous Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hepatitis C
Lead sponsor: Mitsubishi Tanabe Pharma Corporation
Sponsor class: INDUSTRY
Collaborators: name: Vertex Pharmaceuticals Incorporated
First posted: 2008-10-28
Enrollment: 32
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study will evaluate the efficacy and safety of MP-424 with Peginterferon Alfa-2b and RBV in patients with (Genotype 1) hepatitis C, who did not respond to previous treatment.


Eligibility criteria: Inclusion Criteria:

* Genotype 1, chronic hepatitis C
* Non-responders (patient who did not respond to previous treatment)
* Able and willing to follow contraception requirements

Exclusion Criteria:

* Cirrhosis of the liver or hepatic failure
* Hepatitis B surface antigen-positive or HIV antibodies-positive
* History of, or concurrent hepatocellular carcinoma
* History of, or concurrent depression, schizophrenia; or suicide attempt in the past
* Pregnant, lactating, or suspected pregnant patients, or male patients whose female partner is pregnant

Primary outcomes:
measure: The Percentage of Subjects Achieving Undetectable Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) at 24 Weeks After Completion of Drug Administration (SVR, Sustained Viral Response)
timeFrame: After 24 weeks of follow-up
Secondary outcomes:
Other outcomes:
Locations:
city: Kawasaki City
country: Japan
facility: Toranomon Hospital
state: Takatsu-ku
Study officials:
affiliation: Department of Hepatology, Toranomon Hospital
name: Fumitaka Suzuki, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hayashi N, Okanoue T, Tsubouchi H, Toyota J, Chayama K, Kumada H. Efficacy and safety of telaprevir, a new protease inhibitor, for difficult-to-treat patients with genotype 1 chronic hepatitis C. J Viral Hepat. 2012 Feb;19(2):e134-42. doi: 10.1111/j.1365-2893.2011.01528.x. Epub 2011 Nov 8.
Clinical trial NCT04738474: Assessing and Promoting Resilience in Patients With Adult Congenital Heart Disease
Official title: Assessing and Promoting Resilience in Patients With Adult Congenital Heart Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Congenital Heart Disease
Keywords: resilience
adult congenital heart disease
stress management
advance care planning
Lead sponsor: University of Washington
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2021-02-04
Enrollment: 78
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: The purpose of this study is to evaluate the feasibility and preliminary efficacy of the Promoting Resilience in Stress Management (PRISM) intervention in patients with adult congenital heart disease.

Detailed description: After consent is obtained, eligible patients (moderate or complex ACHD, stages B, C, or D) will complete the baseline study measures assessment and be randomized to receive PRISM or usual care (anticipated n=86, 43 per group). Patients in the intervention group will participate in the six PRISM sessions over 3 months. At 3 months following enrollment, patients in both groups will again complete study measures. We will define feasibility as a) the proportion of eligible patients who enroll and b) the proportion of patients who complete the intervention among those randomized to intervention. We will define preliminary efficacy as the change in mean resilience from baseline to 3 months after randomization between those randomized to intervention and usual care. Exploratory analyses will examine PRISM's impact on patient-centered outcomes of quality of life, symptoms of anxiety and depression, and perceived competence for health care.

Eligibility criteria: Inclusion Criteria:

* adults with moderate or complex ACHD, stages B, C, or D as defined by the 2018 ACHD guidelines
* receive care in our health system

Exclusion Criteria:

* diagnosis of another life-limiting illness
* inability to participate in study activities independently and in English

Primary outcomes:
measure: The proportion of patients who enroll in the study among those eligible during the recruitment period
timeFrame: 3 months
measure: The proportion of patients who complete the PRISM intervention among those randomized to intervention.
timeFrame: 3 months
Secondary outcomes:
measure: Resilience
timeFrame: 3 months
Other outcomes:
measure: Health-Related Quality of Life
timeFrame: 3 months
measure: Psychological Distress
timeFrame: 3 months
measure: Competence in Managing Healthcare
timeFrame: 3 months
Locations:
city: Seattle
country: United States
facility: University of Washington
state: Washington
Study officials:
affiliation: University of Washington
name: Jill M Steiner, MD,MS
role: PRINCIPAL_INVESTIGATOR
References: