louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02353195: Effects of Radio-frequency in Patients With Myofascial Chronic Neck Pain
Official title: "Analgesic Effects of Capacitive Resistive Monopolar Radio-frequency (448 kHz) in Patients With Myofascial Chronic Neck Pain: A Pilot Randomized Controlled Trial."
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Neck Pain
Lead sponsor: Universidad Rey Juan Carlos
Sponsor class: OTHER
First posted: 2015-02-02
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study was to evaluate the potential clinical benefits of Monopolar Capacitive Resistive Radio-frequency (448 kHz) (MCRR)F for the treatment of myofascial chronic neck pain.

Detailed description: A randomized, double-blind, placebo-controlled trial. Setting: University community.

Patients with myofascial chronic neck pain with active MTrP in one upper trapezius muscle were involved. The patients were randomly divided into two groups: a radiofrequency group (RFG), who (14 patients) received 8 sessions of a monopolar capacitive resistive radiofrequency (MCRRF) application over the upper trapezius muscle and ten patients received 8 sessions of placebo radiofrequency (PG) over the same muscle. Main outcome measures: Visual analog scale (VAS), neck disability index (NDI) and cervical range of motion (pre-treatment, immediately post-first session treatment and post-treatment.

Eligibility criteria: Inclusion Criteria:

-Patients aged between 18 and 60 years with myofascial chronic neck pain. The area of neck pain was defined as the cervical region, possibly with referred or radiating pain into the occiput, nuchal muscles, shoulders and upper limbs. Symptoms had to have been present for at least six months before. At least one active MTrP in one upper trapezius muscle had to be present. For bilateral neck pain, the most painful side was designated for treatment.

Exclusion Criteria:

* Severe disorders of the cervical spine, such as spinal stenosis, disk prolapse, postoperative conditions of the neck and shoulder areas, history of severe trauma, whiplash, spasmodic torticollis, instability, migraine, peripheral nerve entrapment, fibromyalgia, shoulder diseases, inflammatory rheumatic diseases, severe psychiatric illness and pregnancy.

Primary outcomes:
measure: Visual analogue scale (VAS).
timeFrame: 1 month
Secondary outcomes:
measure: Neck disability
timeFrame: 1 month
measure: Cervical Range of Motion
timeFrame: 1 month
Other outcomes:
Locations:
Study officials:
affiliation: Universidad Rey Juan Carlos
name: Josué Fernández-Carnero, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Diego IMA, Fernandez-Carnero J, Val SL, Cano-de-la-Cuerda R, Calvo-Lobo C, Piedrola RM, Oliva LCL, Rueda FM. Analgesic effects of a capacitive-resistive monopolar radiofrequency in patients with myofascial chronic neck pain: a pilot randomized controlled trial. Rev Assoc Med Bras (1992). 2019 Feb;65(2):156-164. doi: 10.1590/1806-9282.65.2.156.
Clinical trial NCT00556595: Primary Anatomical Versus Primary Electrophysiological Approach in Circumferential Pulmonary Vein Ablation
Official title: Circumferential Pulmonary Vein Ablation in Paroxysmal Atrial Fibrillation: Randomized Comparison Between a Primary Anatomical Versus a Primary Electrophysiological Approach
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Paroxysmal Atrial Fibrillation
Keywords: atrial fibrillation
paroxysmal
symptomatic
drug-refractory
Lead sponsor: University Hospital, Bonn
Sponsor class: OTHER
First posted: 2007-11-12
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Randomized comparison between 2 techniques of circumferential pulmonary vein ablation in paroxysmal atrial fibrillation: Primary anatomical ablation with secondary closure of possible electrical gaps versus primary electrophysiological ablation at the sites of atrio-venous electrical breakthroughs with secondary circumferential ablation around the pulmonary vein orifice


Eligibility criteria: Inclusion Criteria:

* paroxysmal atrial fibrillation
* age over 18 years

Exclusion Criteria:

* persistent atrial fibrillation
* reversible cause of atrial fibrillation
* inability to comply with follow-up

Primary outcomes:
measure: Freedom from atrial tachyarrhythmias at 6-months follow-up
timeFrame: 6 months
Secondary outcomes:
measure: Comparison of procedural characteristics (duration, fluoroscopy time, ablation time, ablation energy, complications)
timeFrame: 6 months
Other outcomes:
Locations:
Study officials:
affiliation: University Hospital Bonn, Department of Cardiology
name: Lars M Lickfett, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Oral H, Scharf C, Chugh A, Hall B, Cheung P, Good E, Veerareddy S, Pelosi F Jr, Morady F. Catheter ablation for paroxysmal atrial fibrillation: segmental pulmonary vein ostial ablation versus left atrial ablation. Circulation. 2003 Nov 11;108(19):2355-60. doi: 10.1161/01.CIR.0000095796.45180.88. Epub 2003 Oct 13.
citation: Arentz T, Weber R, Burkle G, Herrera C, Blum T, Stockinger J, Minners J, Neumann FJ, Kalusche D. Small or large isolation areas around the pulmonary veins for the treatment of atrial fibrillation? Results from a prospective randomized study. Circulation. 2007 Jun 19;115(24):3057-63. doi: 10.1161/CIRCULATIONAHA.107.690578. Epub 2007 Jun 11.
citation: Karch MR, Zrenner B, Deisenhofer I, Schreieck J, Ndrepepa G, Dong J, Lamprecht K, Barthel P, Luciani E, Schomig A, Schmitt C. Freedom from atrial tachyarrhythmias after catheter ablation of atrial fibrillation: a randomized comparison between 2 current ablation strategies. Circulation. 2005 Jun 7;111(22):2875-80. doi: 10.1161/CIRCULATIONAHA.104.491530. Epub 2005 May 31.
Clinical trial NCT03575195: Microbiota Intervention to Change the Response of Parkinson's Disease
Official title: Microbiota Intervention to Change the Response of Parkinson's Disease
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: PHASE1
PHASE2
Conditions: Parkinson Disease
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: Nova Southeastern University
name: Gateway Institute for Brain Research
First posted: 2018-07-02
Enrollment: 86
Sex: ALL
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The clinical phenotype of Parkinson's disease (PD) is quite variable, as is the response to and side effects from medications. While many patients respond to carbidopa/levodopa early on, motor fluctuations and dyskinesias can become a problem as the condition progresses, causing significant impairment in function and quality of life. The gut microbiome is of increasing interest in PD, potentially contributing to pathophysiology and clinical phenotype. Furthermore, gut bacteria are capable of metabolizing levodopa, which may decrease its ability to reach the central nervous system and could explain the variable effect seen clinically. Altering the population of drug-metabolizing bacteria could improve the clinical symptoms of PD and the benefit seen with medications. The investigators hypothesize that the gut microbiome in people with PD correlates with their phenotypic characteristics, which can be improved with targeting the microbiome through dietary or therapeutic interventions. The investigators propose a two-part clinical trial. First, a cross-sectional analysis will correlate the microbiome profile with (a) the clinical phenotype of PD and (b) medication response. Second, a randomized, controlled trial, will evaluate the effect of microbiome manipulation on clinical phenotype and medication response. The investigators plan to reduce the level of bacteria through antibiotic use, resetting the potentially disadvantageous microbiome population. Outcomes will include changes in clinical symptoms, alterations in the the microbiome, and changes in serum markers of inflammation. This thorough characterization will broaden our understanding of the gut-brain axis significantly in PD in clinically relevant ways that have yet to be explored.


Eligibility criteria: Inclusion Criteria:

* Parkinson's disease
* Stable on levodopa therapy with fluctuations

Exclusion Criteria:

* Chronic gastrointestinal disease
* Recent antibiotic or probiotic therapy
* Pregnant
* Immunocompromised

Primary outcomes:
measure: MDS-UPDRS Part III
timeFrame: Two weeks
measure: Percent of OFF time according to home motor diaries
timeFrame: Two weeks
Secondary outcomes:
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: University of California San Francisco
state: California
Study officials:
affiliation: University of California, San Francisco
name: Caroline Tanner, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04197895: Clinical and Radiographic Evaluation of Advanced Platelet Rich Fibrin in the Preservation of Alveolar Ridge Following Atraumatic Tooth Extraction
Official title: Clinical and Radiographic Evaluation of Advanced Platelet Rich Fibrin in the Preservation of Alveolar Ridge Following Atraumatic Tooth Extraction: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Socket Preservation
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2019-12-13
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: compare the effect of application of A-PRF in socket preservation after atraumatic tooth extraction and natural healing regarding to bone remodeling . Null hypotheis, after atraumatic extraction, socket with advanced PRF has no difference with socket with blood clot in primary outcome


Eligibility criteria: Inclusion Criteria:

* The inclusion criteria are as follow :

  * patients with an unremarkable medical history
  * subjects with at least one site bordered by minimum of one tooth.
  * Nonsmoker
  * Teeth with root fracture, teeth with failed endodontic therapy or advanced caries
  * Intact extraction socket with no dehiscence or fenestration.
  * The buccolingual thickness of the buccal plate of bone in surgical area is 1 mm or more

Exclusion Criteria:

* Patients with systemic diseases.
* Patients with presence or history of osteonecrosis of the jaws, with use of bisphosphonates, exposure to head and neck radiation, chemotherapy.
* patients with large distinct pre-apical pathology

Primary outcomes:
measure: mesial and distal height of extraction site
timeFrame: 2 months
Secondary outcomes:
measure: soft tissue thickness
timeFrame: 2 months
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00048295: Alicaforsen (ISIS 2302) in Patients With Active Crohn's Disease
Official title: ISIS 2302-CS21, Phase 3 Double-Masked, Placebo-Controlled Study of Alicaforsen (ISIS 2302), an Antisense Inhibitor of ICAM-1, for the Treatment of Patients With Active Crohn's Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Crohn's Disease
Lead sponsor: Ionis Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
First posted: 2002-10-30
Enrollment: 150
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Primary purpose: TREATMENT

Brief summary: ISIS 2302 is an antisense oligonucleotide drug that reduces the production of a specific protein called intercellular adhesion molecule (ICAM-1), a substance that plays a significant role in the increase of inflammation. People with Crohn's disease have been shown to over-produce ICAM-1 in their gut tissues. Alicaforsen works by blocking ICAM-1 messenger RNA, the "instruction" molecule that is required for the production of ICAM-1 protein. This trial will examine effects of alicaforsen delivered by 2-hour intravenous infusion over a four-week period, compared to a placebo. Patients may remain on stable background 5-ASA, antibiotic, or immunosuppressive drugs, and prednisone (or equivalent) at \</= 30 mg per day.


Eligibility criteria: Inclusion Criteria

1. Age \>/= 12 years
2. Weight \>/= 36 kg
3. CDAI score of 220 - 400
4. Documentation of Crohn's disease activity by endoscopy, biopsy or imaging in the last 2 years
5. No TNF-α inhibitor treatment for three months prior to first study drug infusion

Exclusion Criteria

1. Known severe, fixed, symptomatic stenosis of the small or large intestine with significant dilation
2. Extensive external fistulization (\> 3 external fistulae which are expressible with gentle compression); colostomy or ileostomy
3. Active infection, including infectious colitis, or infection with HIV, Hepatitis B or Hepatitis C
4. Malignancy within 3 years or poorly controlled medical illness
5. Requires intravenous heparin therapy or with a history of a bleeding problem

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Kortrijk
country: Belgium
city: Roeselare
country: Belgium
city: Hradic Kralove 2
country: Czechia
city: Olomouc
country: Czechia
city: Prague
country: Czechia
city: Praha
country: Czechia
city: Usti nad Orlici
country: Czechia
city: Minden
country: Germany
city: Munster
country: Germany
city: Torino
country: Italy
city: Krakow
country: Poland
city: Szczecin
country: Poland
city: Warszawa
country: Poland
city: Wroclaw
country: Poland
city: Barcelona
country: Spain
city: Valencia
country: Spain
Study officials:
References:
Clinical trial NCT04687995: Tragal Perichondrium Versus Pretragal Fascial (SMAS) Graft for Endoscopic Myringoplasty
Official title: The Tragal Perichondrium Versus the Pretragal Fascial Grafts for Endoscopic Myringoplasty: Comparative Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Tympanic Membrane Perforation
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2020-12-29
Enrollment: 40
Sex: ALL
Minimum age (years): 16
Maximum age (years): 50
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 1. Examine the treatment outcomes of the pretragal (SMAS) fascia as a new graft when used in endoscopic myringoplasty.
2. Compare the results when using the tragal pericondrium as a graft in endoscopic myringoplasty regarding donor site and success.

Detailed description: The exclusive transcanal endoscopic tympanoplasty technique emerged in the1990s : it provides a more direct and wider surgical viewing angle, largely reduces the necessity for a traumatic postauricular incision. Some otolgists have adopted this technique using the nearby tragal perichondrium/cartilage graft. The tragus has a pivotal function in reconstruction in ear surgery. The superficial musculoaponeurotic system (SMAS) was first introduced by Mits and Peyroniein1976. It is located in the mid-face overlying the parotid gland and mimic muscles, It connects the dermis and the muscles, acting as a unique motor unit to produce facial expressions. The SMAS graft has great potential because it is accessible from the least invasive transcanal route of tympanoplasty, and is located away from the vital structures.

Eligibility criteria: Inclusion Criteria:

1. Above 16 yrs old and less than 50 yrs old.
2. Clinically diagnosed central tympanic membrane perforations or chronic suppurative otitis media (tubo-tympanic).
3. Dry ear: no otorrhea without medication for at least 1 month.
4. Hearing loss gap not more than 50dB

Exclusion Criteria:

1. Age less than 16 or more than 50.
2. Discharging (active) central perforations.
3. Unsafe CSOM with cholesteatoma.
4. Suspected ossicular pathology in safe CSOM if the gap \> 50dB.
5. Previous ear surgery.
6. Patients unfit for surgery or having chronic medical illness.

Primary outcomes:
measure: comparison of tragal perichondrium versus pretragal fascial (SMAS) graft for endoscopic myringoplasty
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Lin MY, Chang TS, Liao JB. The Pretragal Superficial Musculoaponeurotic System Fascia: A New Graft Material for Transcanal Tympanoplasty. Otol Neurotol. 2020 Jun;41(5):644-653. doi: 10.1097/MAO.0000000000002599.
Clinical trial NCT02945995: Outcome After Arthroscopic Surgery in Patients Treated With PAO
Official title: Outcome After Arthroscopic Labrum Surgery in Patients Treated With Periacetabular Osteotomy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Developmental Dysplasia of the Hip
Lead sponsor: Aarhus University Hospital
Sponsor class: OTHER
First posted: 2016-10-26
Enrollment: 45
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients undergoing hip arthrocopy previous treated with periacetabular osteotomy

Brief summary: The purpose of the study is to evaluate outcome after arthroscopy if the hip in patients previous treated with periacetabular osteotomy

Detailed description: It is well known the patients with developmental dysplasia of the hip beyond the bony malformation has intraarticular damage to labrum and chondral structures.

In DK, if the patients has persistent pain in the hip joint after PAO, they have been offered a hip arthroscopy, however we do not if their hip functions and pain improved by the surgery

The investigator aimed to make a short to middle-term followup study to see if the patients had benefits of the surgery.

Eligibility criteria: Inclusion Criteria:

* previous PAO and hip arthroscopy
* developmental dysplasia of the hip

Exclusion Criteria:

* calve legg perthes disease
* femoral osteotomy

Primary outcomes:
measure: Number of patient with the need of a total hip arthroplasty after PAO and hip arthroscopy
timeFrame: 48 months after hip arthroscopy
Secondary outcomes:
measure: Evaluation of the patients pain in rest and during activity on a NRS Scale
timeFrame: 48 months after hip arthroscopy
measure: Evaluation of hip function and pain using MHHS (modified harris hip score)
timeFrame: 48 months after hip arthroscopy
measure: Evaluation of hip function and pain using HOS (Hip outcome score)
timeFrame: 48 months after hip arthroscopy
Other outcomes:
Locations:
Study officials:
affiliation: Aarhus University Hospital
name: Martin Lind, MD,PhD,DmSc
role: STUDY_DIRECTOR
References:
Clinical trial NCT00329095: An Evaluation of Use of Topical Ocular Hypotensive Medication by Compliance
Official title: An Evaluation of Use of Topical Ocular Hypotensive Medication by Electronic Compliance Measures
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Glaucoma
Ocular Hypertension
Keywords: Glaucoma
Compliance
Lead sponsor: Robin, Alan L., M.D.
Sponsor class: INDIV
First posted: 2006-05-24
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: This is an open-label study in patients who are currently using either a topical prostaglandin as sole ocular hypotensive medical therapy q.d., or a topical prostaglandin plus an adjunctive topical ocular hypotensive marketed product either q.d., or b.i.d. in the same eye(s). Compliance will be measured over the two months of participation.

Detailed description: This is an open-label study in patients who are currently using either a topical prostaglandin as sole ocular hypotensive medical therapy q.d., or a topical prostaglandin plus an adjunctive topical ocular hypotensive marketed product either q.d., or b.i.d. in the same eye(s). Compliance will be measured over the two months of participation.

Eligibility criteria: Inclusion Criteria:

* Currently using one or two topical ocular hypotensive medications

Exclusion Criteria:

* Hypersensitivity to any component of medication

Primary outcomes:
measure: Compliance.
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Alan L. Robin, M.D.
name: Alan L. Robin, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Robin AL, Novack GD, Covert DW, Crockett RS, Marcic TS. Adherence in glaucoma: objective measurements of once-daily and adjunctive medication use. Am J Ophthalmol. 2007 Oct;144(4):533-40. doi: 10.1016/j.ajo.2007.06.012. Epub 2007 Aug 8.
Clinical trial NCT02224495: The Effect of Exercise Training on Cardiac Structure and Function
Official title: The Effect of Exercise Training on Cardiac Structure and Function
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Myocardial Infarction
Lead sponsor: Gaia Hospital
Sponsor class: OTHER
Collaborators: name: Universidade do Porto
First posted: 2014-08-25
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Exercise training, as part of cardiac rehabilitation, is effective in improving functional capacity and quality of life in patients with coronary artery disease. Other cardiovascular and non-cardiovascular benefits have been reported, namely in glucose metabolism, skeletal muscle function, oxidative stress, vascular function, pulmonary circulation, ischaemia-reperfusion lesion and ventricular remodelling.

However, the benefit of exercise training on systolic and diastolic function is controversial especially after acute myocardial infarction where no longitudinal study has evaluated diastolic function using modern echocardiographic parameters.

The hypothesis is that a structured program of exercise training can improve systolic and diastolic function in patients after myocardial infarction.


Eligibility criteria: Inclusion Criteria:

* Patients one month after myocardial infarction
* Older 18 years

Exclusion Criteria:

* Age above 75 years,
* Inability to exercise,
* Hemodinamically significant valvular disease,
* Moderate to severe chronic lung disease (vital capacity and/or forced expiratory volume in 1 s \<80% of age-dependent predicted value),
* Atrial fibrillation
* Exercise induced myocardial ischemia
* Anaemia (haemoglobin \<12 g/dl).

Primary outcomes:
measure: Myocardial early diastolic velocity at mitral annulus by tissue Doppler (E' velocity)
timeFrame: 4 months
Secondary outcomes:
measure: Ratio between early diastolic filling velocity from mitral inflow and myocardial early diastolic velocity at mitral annulus by tissue Doppler (E/E' ratio)
timeFrame: 4 months
measure: Myocardial systolic velocity at mitral annulus by tissue Doppler (S' velocity)
timeFrame: 4 months
measure: Left ventriclular ejection fraction
timeFrame: 4 months
Other outcomes:
Locations:
city: Gaia
country: Portugal
facility: Cardiology Department Gaia Hospital Center
Study officials:
affiliation: Universidade do Porto
name: Adelino Leite-Moreira, PhD
role: STUDY_DIRECTOR
References:
citation: Fontes-Carvalho R, Sampaio F, Teixeira M, Gama V, Leite-Moreira AF. The role of a structured exercise training program on cardiac structure and function after acute myocardial infarction: study protocol for a randomized controlled trial. Trials. 2015 Mar 12;16:90. doi: 10.1186/s13063-015-0612-6.