louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03212599: Disulfiram as a Modulator of Amyloid Precursor Protein-processing
Official title: Quantitative Analysis of the Expression of Dementia-relevant Genes by Intake of the Drug Disulfiram
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Alcohol Addiction
Keywords: APP-processing
Disulfiram
ADAM10
Alzheimer's disease
blood
Lead sponsor: Johannes Gutenberg University Mainz
Sponsor class: OTHER
First posted: 2017-07-11
Enrollment: 17
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Recruited are alhohol addicted patients, which take Disulfiram as recrudescence prevention after successful detoxication. Patients between 20 and 60 years of age are included in the study independent from gender or ethnic background

Brief summary: A causal therapeutic approach for treatment of Alzheimer's disease has not been established so far. The protein ADAM10 represents a promising target for an A-beta peptide preventing strategy. Treatment of human neuronal cells with Disulfiram, a drug which is used in clinical routine for recrudescence prevention of alcohol dependency, revealed an increased expression of ADAM10. This finding indicates a neuroprotective potential of Disulfiram. The investigators' research purpose aims at the verification of the results obtained in cell culture experiments in the human organism. Therefore, include alcohol addicted patients were included, which take the drug Disulfiram for recrudescence prevention, in our study. Patients are recruited from the patient-collective of the University Medical Center Mainz and the Central Institute for Mental Health Mannheim. Blood samples (max. 5 ml) are taken from the participants before the intake of Disulfiram and about two weeks after treatment. Demographic data are collected (such as age or onset of addiction). Gene expression is analyzed via reverse transcription polymerase chain reaction(RT-PCR) from blood cell-derived messenger ribonucleic acid (mRNA).


Eligibility criteria: Inclusion Criteria:

ambulant or stationary patients, which receive Disulfiram for recrudescence prevention

Exclusion Criteria:

Diagnosed Alzheimer's dementia Previous Disulfiram treatment less than four weeks before baseline blood collection

Primary outcomes:
measure: expression of ADAM10
timeFrame: August 2016
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Medical Center Johannes Gutenberg University
name: Kristina Endres
role: PRINCIPAL_INVESTIGATOR
References:
citation: Saifi MA, Shaikh AS, Kaki VR, Godugu C. Disulfiram prevents collagen crosslinking and inhibits renal fibrosis by inhibiting lysyl oxidase enzymes. J Cell Physiol. 2022 May;237(5):2516-2527. doi: 10.1002/jcp.30717. Epub 2022 Mar 13.
Clinical trial NCT02670499: Study Comparing GAP-Flex to CPM Therapy in Treatment of TKR
Official title: A Randomized Controlled Multicenter Study Comparing GAP-FLEX to Continuous Passive Motion (CPM) Therapy in Combination With Standard of Care Physical Therapy in Subjects With Total Knee Replacement (TKR)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Total Knee Replacement
Lead sponsor: Xeras Medical Technologies
Sponsor class: INDUSTRY
First posted: 2016-02-01
Enrollment: 28
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Post Market TKR study

Detailed description: A post-market study to evaluate the safety and effectiveness of the GAP-FLEX device in combination with standard of care physical therapy compared to the standard of care CPM device in combination with standard of care physical therapy in Subjects who have undergone TKR

Eligibility criteria: Inclusion Criteria:

* Minimum age 50 years
* Subject is undergoing total knee replacement
* Subject agrees to comply with the physical therapy regime

Exclusion Criteria:

* With a flexure contracture \> 10 degrees
* Degree of flexion \< 60 degrees pre-procedure or immediately post-procedure
* Severe motion restriction as determined by the investigator
* Severe deformity determined by the investigator
* Taking chronic pain medication for use other than knee pain
* Post surgery hospital stay is \> 4 days
* Knee disorders other than osteoarthritis
* With fibromyalgia
* Chronic narcotic use as determined by the investigator.
* Have a medical or psychological history that in the opinion of the investigator would make the subject a poor candidate for the study.
* Who need a revision implant
* Who have participated in clinical study within the past 30 days (prior to enrollment) that may affect the outcome of this study
* Amputations below or above knee of non-operated leg
* Weight is \>250 pounds and/or morbidly obese (BMI \> 40)
* History of blood clots
* Deep vein thrombosis
* Females who are pregnant
* Females who wish to become pregnant during the length of study participation
* Subjects with any of the following post-surgery conditions;
* Screws needed
* Intraoperative identification of a fracture or soft bone
* Admitted to ICU
* Additional procedures (other than TKR) needed for other identified or pre-existing conditions

Primary outcomes:
measure: Flexion
timeFrame: Degree of flexion achieved at week 4 visit
Secondary outcomes:
Other outcomes:
Locations:
city: San Antonio
country: United States
facility: Nix Orthopaedic Center
state: Texas
city: San Antonio
country: United States
facility: Orthopaedic Institute
state: Texas
Study officials:
References:
Clinical trial NCT00000242: Carbamazepine Treatment of Cocaine Dependence - 1
Official title: Carbamazepine Treatment of Cocaine Dependence
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Cocaine-Related Disorders
Substance-Related Disorders
Keywords: Cocaine
Substance Abuse
Lead sponsor: Medical University of South Carolina
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 1999-09-21
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare the efficacy of carbamazepine in treatment of cocaine-dependence in patients with affective disorders.


Eligibility criteria: Please contact site for information.

Primary outcomes:
measure: Severity addiction
measure: Amount of drug use
measure: Affective stability
measure: Medication compliance
Secondary outcomes:
Other outcomes:
Locations:
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
Study officials:
affiliation: Medical University of South Carolina
name: Kathleen Brady, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Brady KT, Sonne S, Randall CL, Adinoff B, Malcolm R. Features of cocaine dependence with concurrent alcohol abuse. Drug Alcohol Depend. 1995 Jul;39(1):69-71. doi: 10.1016/0376-8716(95)01128-l.
Clinical trial NCT00532142: The ROVO Study: Radial Optic Neurotomy for CVO
Official title: A Multicenter Trial for Surgical Treatment of Central Retinal Vein Occlusion - Radial Optic Neurotomy for CVO The ROVO Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Central Retinal Vein Occlusion
Lead sponsor: Rudolf Foundation Clinic
Sponsor class: OTHER
First posted: 2007-09-20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The ROVO study is a prospective, placebocontrolled and randomised study designed to evaluate the effect of radial optic neurotomy in central vein occlusion, versus triamcinolone acetonide. 240 patients with a visual acuity \< 0.5 Snellen will be randomised. Patients are treated with either RON, or a single intravitreal injection of 4 mg triamcinolone acetonide, or a placebo treatment - a "sham" injection of intravitreal triamcinolone. Patients will be examined regularly over a period of one year.

Best corrected visual acuity for far and near, as well as clinical examinations, fluorescein- and indocyanine green angiograms, optical coherence tomography, and perimetry, are performed pre- and postoperatively.


Eligibility criteria: Inclusion Criteria:

* Onset of CVO not longer than 12 months
* On FLA 1. nonperfused - (greater than 10 disc area of nonperfusion) 2. perfused - visual acuity lower than 0.1 Snellen,or 3. perfused with no improvement of visual acuity over 4 weeks)

Exclusion Criteria:

* • Dense cataract\* (grade 3 and 4) which precludes judgement of the fundus.

  * Pregnancy
  * Allergy against Fluoresceine or Indocyanine green
  * Unable to come for follow up visit
  * Presence of other severe retinopathy or
  * Presence of advanced optic atrophy or uncontrolled glaucoma.
  * Visual acuity higher than 0.5 Snellen.

Primary outcomes:
measure: Proportion of eyes with an improvement of more than 15 letters (approximately > 3 lines of visual acuity gain) after one year as compared to baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Rudolf foundation Clinic
Study officials:
affiliation: no affiliation
name: Susanne Binder, M.D.
role: STUDY_CHAIR
References:
citation: Aggermann T, Brunner S, Krebs I, Haas P, Womastek I, Brannath W, Binder S; ROVO Study Group. A prospective, randomised, multicenter trial for surgical treatment of central retinal vein occlusion: results of the Radial Optic Neurotomy for Central Vein Occlusion (ROVO) study group. Graefes Arch Clin Exp Ophthalmol. 2013 Apr;251(4):1065-72. doi: 10.1007/s00417-012-2134-1. Epub 2012 Sep 8.
Clinical trial NCT01915342: Developing Optimal Focal Muscle Vibration for Improving Spasticity
Official title: Optimization of Physical Focal Stimulation Parameters for Improving Spasticity and Identification of Neurophysiological Mechanism
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Vibration
Electrophysiology
Muscle Spasticity
Keywords: Monosynaptic reflex
H-reflex
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
Collaborators: name: Korea Institute of Science and Technology
First posted: 2013-08-02
Enrollment: 17
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The overall aim of the proposed study is to determine optimal parameter of focal muscle vibration for improving spasticity and identify neurophysiological mechanism in healthy subjects.

In investigation I-1, subjects will undergo focal muscle vibration with 40, 80, 120 Hz frequency at the medial gastrocnemius muscles (mGCM). As a surrogate maker of spasticity, H-reflex and compound motor action potential (CMAP) of the tibial nerve at mGCM will be recorded pre, during, and post vibration.

In investigation I-2, subjects will undergo focal muscle vibration with 0.1, 0.3, 0.5 mm amplitude at mGCM. H-reflex and CMAP of the tibial nerve at mGCM will be recorded pre, during, and post vibration.

In investigation II, subjects will undergo focal muscle vibration with predetermined parameters by the investigation I at mGCM. H-reflex and CMAP of the tibial nerve and motor evoked potential at mGCM will be recorded pre, during, and post vibration.


Eligibility criteria: Inclusion Criteria:

* Healthy volunteer

Exclusion Criteria:

* Unstable medical conditions
* History of epilepsy
* History of drug abuse

Primary outcomes:
measure: H/M ratio
timeFrame: baseline, 1, 5 and 10 minutes during vibration, and 1 and 5 minutes after vibration
Secondary outcomes:
measure: H amplitude
timeFrame: baseline, 1, 5 and 10 minutes during vibration, and 1 and 5 minutes after vibration
measure: M amplitude
timeFrame: baseline, 1, 5 and 10 minutes during vibration, and 1 and 5 minutes after vibration
measure: motor evoked potential (MEP) amplitude
timeFrame: baseline, 10 minutes during vibration, and 5 minutes after vibration
measure: Resting motor threshold (RMT)
timeFrame: baseline, 10 minutes during vibration, and 5 minutes after vibration
measure: Short interval intracortical inhibition
timeFrame: baseline, 10 minutes during vibration, and 5 minutes after vibration
measure: Intracortical facilitation
timeFrame: baseline, 10 minutes during vibration, and 5 minutes after vibration
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
References:
Clinical trial NCT03691142: Evaluation of Obstetrical and Neonatal Complications in Hereditary Haemorrhagic Telangiectasia (HHT)
Official title: A Retrospective Study of Obstetrical and Neonatal Complications in Hereditary Haemorrhagic Telangiectasia (HHT)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Osler Rendu Disease
Hereditary Hemorrhagic Telangiectasia
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2018-10-01
Enrollment: 207
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women with Hereditary Haemorrhagic Telangiectasia and one or more past pregnancies.

Brief summary: Hereditary Haemorrhagic Telangiectasia (HHT) is a rare inherited genetic disease of autosomal dominant inheritance with a prevalence of about 1/5000. It is manifested by haemorrhage, mucocutaneous telangiectasia and visceral arteriovenous malformations (AVMs) (lung, liver and nervous system).

Severe complications during pregnancy in HHT are rare but considered high risk. Intracranial or pulmonary haemorrhage, stroke and heart failure have been reported in some women with HHT during pregnancy. These complications occur most often in the second and third trimesters when maternal physiological changes such as peripheral vasodilatation and increased cardiac output are at their peak.

Previous retrospective studies were conducted with numbers ranging from 40 to 97 patients and highlighted the importance of early screening of complications and specific management.

The aim of this study is to describe, on a larger number of patients, the obstetric and neonatal complications in patients with HHT and followed in the French Reference Center for HHT.


Eligibility criteria: Inclusion Criteria:

* Women ≥ 18 years.
* Patients monitored for clinically confirmed Hereditary Haemorrhagic Telangiectasia (presence of at least three Curaçao criteria) and / or with molecular biology confirmation.
* Patients with at least 1 full term pregnancy between 1960 and 2018.
* Received information and no opposition to participate in the study.

Exclusion Criteria:

* No full term pregnancies.
* Refusal to participate in the study.

Primary outcomes:
measure: Occurrence of complications during pregnancy
timeFrame: Interview time (about 15 minutes)
Secondary outcomes:
Other outcomes:
Locations:
city: Bron
country: France
facility: Centre de Référence pour la maladie de Rendu-Osler Service Génétique Clinique Bâtiment A1 - Hôpital Femme-Mère-Enfant - Hospices Civils de Lyon
Study officials:
References:
Clinical trial NCT00602342: Bioequivalency Study of Terbinafine Tablets Under Fasting Conditions
Official title: A Single Dose, Two-Period, Two-Treatment, 2-Way Crossover Bioequivalency Study of 250 mg Terbinafine Hydrochloride Tablets Under Fasting Conditions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Onychomycosis
Lead sponsor: West-Ward Pharmaceutical
Sponsor class: INDUSTRY
First posted: 2008-01-28
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: TREATMENT

Brief summary: The objective of this study was the bioequivalence of a Roxane Laboratories' terbinafine tablets, 250 mg, to Lamisil® Tablets, 250 mg (Novartis Pharmaceutical Corporation.) under fasting conditions using a single-dose, randomized, 2-treatment, 2-period, 2-sequence crossover design.


Eligibility criteria: Inclusion Criteria:

* No clinically significant abnormal findings on the physical examination, medical history, or clinical laboratory results during screening.

Exclusion Criteria:

* Positive test for HIV, Hepatitis B, or Hepatitis C.
* Treatment with known enzyme altering drugs.
* History of allergic or adverse response to terbinafine or any comparable or similar product.

Primary outcomes:
measure: Bioequivalence
timeFrame: Baseline, Two period, Twenty-one day washout
Secondary outcomes:
Other outcomes:
Locations:
city: Saint Charles
country: United States
facility: Gateway Medical Research, Inc.
state: Missouri
Study officials:
affiliation: Cetero Research, San Antonio
name: Steven Herrmann, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00676442: Study Evaluating the Effect of Food on the Bioavailability of PN400 Components
Official title: An Open-Label, Randomized, Four-Way Crossover Study to Evaluate the Effect of Food on the Bioavailability of Naproxen and Esomeprazole From a PN 400 Tablet in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Arthritis
Lead sponsor: POZEN
Sponsor class: INDUSTRY
First posted: 2008-05-13
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: We will evaluate the effect of food on the bioavailability of the components of PN400


Eligibility criteria: Inclusion Criteria:

* Healthy male or non-pregnant female subjects between 18-55 years old as well as other standard inclusion criteria for a study of this nature.

Exclusion Criteria:

* Standard exclusion criteria for a study of this nature.

Primary outcomes:
measure: To determine the effects of food eaten at different times on the bioavailability of the components of PN400 following a single oral dose in healthy subjects.
timeFrame: 72-hours
Secondary outcomes:
measure: To assess the safety and tolerability of PN 400 under fasting and fed conditions.
timeFrame: entire study duration
Other outcomes:
Locations:
city: Austin
country: United States
state: Texas
Study officials:
References:
Clinical trial NCT04503642: Changing the Surgical Team for Wound Closure and Surgical Site Infection
Official title: Impact of Changing the Surgical Team for Wound Closure on Surgical Site Infection: a Matched Case-control Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Incidence of Surgical Site Infection
Morality
Fascial Hernia
Keywords: Surgical Site Infection
Changing the surgical team
Lead sponsor: Insel Gruppe AG, University Hospital Bern
Sponsor class: OTHER
First posted: 2020-08-07
Enrollment: 1160
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Department of Visceral Surgery of the University Hospital Bern, a tertiary care centre

Brief summary: Surgical site infection is a frequent complication after abdominal surgery. The wound closure is done at the end of the procedure when the attention of the entire team may be affected because of tiredness and reduced attention of the surgical team.

With this study, the investigators aim to test if an exchange of the surgical team by a specialised wound closure team may reduce the impact of surgical site infection.


Eligibility criteria: Inclusion Criteria:

* General Consent as documented by signature
* Patients undergoing elective or emergency abdominal surgery from Monday to Friday with wound closure from 8:00 until 17:30 and duration of operation.
* Age over 18 years

Exclusion Criteria:

* Patients \< 18 years of age
* Patients with preexisting SSI

Primary outcomes:
measure: Number of patients with SSIs
timeFrame: 30 days postoperative
Secondary outcomes:
measure: Postoperative Mortality at 30 days
timeFrame: 30 days postoperative
measure: Numbers of patients with fascial dehiscence at 30 days postoperative
timeFrame: 30 days postoperative
measure: Numbers of patients with complications
timeFrame: 30 days postoperative
Other outcomes:
Locations:
city: Berne
country: Switzerland
facility: Dep. of Visceral and transplant surgery, Berne University Hospital
Study officials:
affiliation: Visceral and transplant sugery, university hospital Berne
name: Guido Beldi, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Salm L, Chapalley D, Perrodin SF, Tschan F, Candinas D, Beldi G. Impact of changing the surgical team for wound closure on surgical site infection: A matched case-control study. PLoS One. 2020 Nov 5;15(11):e0241712. doi: 10.1371/journal.pone.0241712. eCollection 2020.
Clinical trial NCT05442242: Unicompartmental Knee Arthroplasty vs. High Tibial Osteotomy for Medial Knee Osteoarthritis (UNIKORN): a Study Protocol of a Randomized Controlled Trial
Official title: Unicompartmental Knee Arthroplasty vs. High Tibial Osteotomy for Medial Knee Osteoarthritis (UNIKORN): a Study Protocol of a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Knee Osteoarthritis
Lead sponsor: Töölö Hospital
Sponsor class: OTHER
First posted: 2022-07-01
Enrollment: 100
Sex: ALL
Minimum age (years): 45
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Unicompartmental knee arthroplasty (UKA) and High Tibial Osteotomy are both valid treatment options for isolated medial knee osteoarthritis. Literature to date is lacking high grade evidence of the outcomes between these procedures. This is a study protocol for randomized controlled trial comparing UKA vs HTO in late stage medial knee osteoarthritis.


Eligibility criteria: Inclusion Criteria:

* Isolated KL 3-4 medial knee arthrosis
* Varus \> 3 degrees
* Age 45-65 years

Exclusion Criteria:

* Post-traumatic arthrosis
* Arthrosis in the lateral compartment more than KL grade I in MRI
* Post- traumatic arthrosis
* Instability
* Malignancy Obesity

Primary outcomes:
measure: KOOS
timeFrame: 1- year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: