louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00304733: Wound Healing: Total Contact Cast Vs. Custom-Made Temporary Footwear for Patients With Diabetic Foot Ulceration
Official title: Wound Healing: Total Contact Cast Vs. Custom-Made Temporary Footwear for Patients With Diabetic Foot Ulceration
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Neuropathic Foot Ulceration in Individuals With Diabetes
Keywords: neuropathic foot ulcerations - total contact cast - custom -made footwear - off-loading
Lead sponsor: Rehabilitation Centre Amsterdam
Sponsor class: OTHER
Collaborators: name: ConvaTec Inc.
name: Ontwikkelingsfonds Orthopedisch maatschoeisel
First posted: 2006-03-20
Enrollment: 43
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Objective: to compare the effectiveness of irremovable total contact casts and custom made temporary footwear to heal neuropathic foot ulcerations in individuals with diabetes

Detailed description: In this prospective clinical trail, 43 patients with plantar ulcer grade 1 or 2 (wagner scale) were randomized to one of two off-loading modalities: total contact cast or custom-made temporary footwear.outcomes assessed were wound surface area reduction (square cm.)and time to wound healing (days0 at 2,4,8 and 16 weeks. to evaluate safety, possible side effects were recorded at each follow-up visit.

Eligibility criteria: Inclusion Criteria:

* confirmed diabetes
* neuropathic ulcer grade 1/2 (wagner scale)
* confirmed sensory neuropathy

Exclusion Criteria:

* osteomyelitis patients unable to walk
* life threatening co-morbidity ankle/brachial index , 0.4

Primary outcomes:
measure: wound surface area reduction
Secondary outcomes:
measure: time to wound healing (days)
Other outcomes:
Locations:
city: Amsterdam
country: Netherlands
facility: Onze Lieve Vrouwe Gasthuis
state: Noord Holland
Study officials:
affiliation: rehabiliation centre amsterdam
name: f. b. van de weg, m.d.
role: STUDY_CHAIR
References:
Clinical trial NCT04748133: Acupuncture for Recovery and Postoperative Nausea and Vomiting After Middle Ear Surgeries
Official title: Acupuncture for Enhancing Recovery and Attenuating Postoperative Nausea and Vomiting After Middle Ear Surgeries: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Treatment Complication
Lead sponsor: Zagazig University
Sponsor class: OTHER_GOV
First posted: 2021-02-10
Enrollment: 59
Sex: ALL
Minimum age (years): 21
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Modern surgery management needs increasing operating room turnover and more ambulatory surgery. In order to come over this challenge, the recovery needs to be optimized. Enhancing recovery could be achieved by preventing postoperative pain and postoperative nausea and vomiting. Middle ear surgery is a common ambulatory surgery with increasing occurrence of postoperative nausea and vomiting.

Detailed description: Sample size: as percent of vomiting following acupuncture and following standard anesthesia is 0.13% and 29.2% respectively so sample size is 58 (29 in each group). Sample is calculated using open epi program with confidence level 95% and power 80%.

Patients in Group C (control group) (n=29): will receive no treatment. While patients in Group A (Acupuncture group) (n=29): will receive needle acupuncture.

Eligibility criteria: Inclusion Criteria:

* Written informed consent from the patient.
* Age: 21-60 years old.
* Sex: both sex (males or females).
* Physical status: ASA 1\& II.
* BMI = (20-30 kg/m2).
* Type of operations: elective unilateral middle ear surgeries such as tempanoplasty, stapedectomy and mastedictomy.

Exclusion Criteria:

* Altered mental state
* Patients with Drug abuse or alcohol.
* Patients with on antipsychotic drugs, regular antiemetic therapy or receiving antiemetic 24 hour before surgery.
* Patients with pre-treatment with acupuncture or trigger point injection.
* Pregnancy.

Primary outcomes:
measure: incidence of postoperative nausea and vomiting
timeFrame: up to 24 hours postoperative
Secondary outcomes:
measure: extubation time
timeFrame: up to 10 minutes postoperative
measure: recovery time
timeFrame: up to 30 minutes postoperative
measure: The time of discharge
timeFrame: up to 30 minutes postoperative
measure: The total number of rescue antiemetic (metoclopramide)
timeFrame: in the first 24 hour postoperative
measure: Postoperative Pain
timeFrame: up to 30 minutes, 2 hours and 4 hours postoperative
measure: number of participant with side effects of acupuncture
timeFrame: up to 24 hours postoperative
Other outcomes:
Locations:
city: Zagazig
country: Egypt
facility: Zagazig University
Study officials:
affiliation: Zagazig University
name: Marwa Zakzouk, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01574833: Early Application of Pulsed Electromagnetic Field in the Treatment of Postoperative Delayed Union
Official title: Phase 4 Study of Early Applied Pulsed Electromagnetic Field in the Treatment of Postoperative Delayed Union of Long-bone Fractures
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Fracture
Delayed Union of Fracture
Lead sponsor: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Sponsor class: OTHER
First posted: 2012-04-10
Enrollment: 92
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: The investigators hypothesized that early applied pulsed electromagnetic field treatment on delayed union might lead to increased rate of fracture union and shortened period of treatment.


Eligibility criteria: Inclusion Criteria:

* The failure of healing after at least 16 weeks and not more than 9 months following surgical reduction and fixation of the fracture.

Exclusion Criteria:

* Implant loosening or failure, infection, established nonunion, fracture gap greater than 5 mm, presence of implant within the fracture gap, metabolic disorders or received medication affecting fracture healing

Primary outcomes:
measure: percentage of patient achieving fracture union
timeFrame: 12 months
Secondary outcomes:
measure: pain
timeFrame: 12 months
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Nanjing Drum Tower Hospital, the Affiliated Hospital of Nanjing University Medical School
state: Jiangsu
Study officials:
References:
Clinical trial NCT06427733: Green Banana Peel Extract for Stasis Dermatitis Treatment
Official title: Green Banana Peel Extract for Stasis Dermatitis Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Stasis Dermatitis
Keywords: Stasis dermatitis
Hyperpigmentation
banana skin
Musa sapientum
Lead sponsor: Universidade do Vale do Sapucai
Sponsor class: OTHER
First posted: 2024-05-24
Enrollment: 20
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: To develop and evaluate a pharmaceutical formula based on green banana peel extract for the treatment of stasis dermatitis.

Detailed description: Objective: to develop and evaluate a pharmaceutical formula based on green banana peel extract for the treatment of stasis dermatitis. Methods: it will be a clinical, interventional, longitudinal study, random sampling, Sample will have 20 patients divided into two groups. In the Control Group, a moisturizing cream with SPF 30 sunscreen plus a pharmaceutical formulation without green banana peel extract will be used, and in the Study Group, in addition to the SPF 30 sunscreen, a pharmaceutical formulation containing green banana peel extract will be used. Patients will undergo treatment for 90 days, applying the formulation twice a day, evaluated every 45 days through clinical, photographic and Chromatic Palette evaluation.

Eligibility criteria: Inclusion Criteria:

* Patients with stasis dermatitis.
* Patients aged 18 years or over and 60 years or less.
* Patients who agree to participate in the study. -

Exclusion Criteria:

* Patients who have other types of hyperchromia in the legs.
* Patients known to have an allergic reaction to bananas.
* Patients who give up, for any reason, to continue treatment.

Primary outcomes:
measure: Occurence of stasis dermatitis
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Pouso Alegre
country: Brazil
facility: Vale do Sapucaí University
state: Minas Gerais
Study officials:
affiliation: Vale do Sapucaí University
name: Adriana R dos Anjos Mendonça, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01128933: Renal Fractional Flow Reserve in Renal Artery Stenting
Official title: Prognostic Value of Renal Fractional Flow Reserve in Hypertensive Patients With Renal Artery Stenosis Qualified to Renal Artery Stenting
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Renal Artery Stenosis
Hypertension
Keywords: Fractional flow reserve
Revascularization
Prognosis
Hemodynamics
Hypertension
Lead sponsor: National Institute of Cardiology, Warsaw, Poland
Sponsor class: OTHER
Collaborators: name: Ministry of Science and Higher Education, Poland
First posted: 2010-05-24
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to determine potential utility of renal fractional flow reserve in prognosis predicting after renal stent implantation.


Eligibility criteria: Inclusion Criteria:

* At least moderate (60% or more) renal artery stenosis with atheromatic appearance in angiography
* Hypertension defined according to WHO criteria
* Age 18-75 years
* Signed informed consent obtained

Exclusion Criteria:

* Bilateral renal artery stenosis or significant renal artery stenosis in solitary kidney
* Contraindications to percutaneous renal angioplasty with stenting
* Atrophy of the kidney supplied with stenosed artery
* Other well known secondary reason for hypertension
* Chronic heart failure NYHA II-IV
* Significant valvular heart disease qualified for surgery
* Persistent atrial fibrillation
* Renal failure with GFR below 30ml/min

Primary outcomes:
measure: Blood pressure improvement
timeFrame: 6 months
Secondary outcomes:
measure: Kidney function preservation
timeFrame: 6 months
Other outcomes:
Locations:
city: Warsaw
country: Poland
facility: Institute of Cardiology
Study officials:
affiliation: National Institute of Cardiology, Warsaw, Poland
name: Jacek Kadziela, MD,PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: National Institute of Cardiology, Warsaw, Poland
name: Adam Witkowski, Prof
role: PRINCIPAL_INVESTIGATOR
affiliation: National Institute of Cardiology, Warsaw, Poland
name: Andrzej Januszewicz, Prof
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kadziela J, Prejbisz A, Michalowska I, Adamczak M, Warchol-Celinska E, Pregowska-Chwala B, Januszewicz M, Wiecek A, Januszewicz A, Witkowski A. Relationship between hemodynamic parameters of renal artery stenosis and the changes of kidney function after renal artery stenting in patients with hypertension and preserved renal function. Blood Press. 2015 Feb;24(1):30-4. doi: 10.3109/08037051.2014.958304. Epub 2014 Sep 30.
citation: Kadziela J, Januszewicz A, Prejbisz A, Michalowska I, Januszewicz M, Florczak E, Kalinczuk L, Norwa-Otto B, Warchol E, Witkowski A. Prognostic value of renal fractional flow reserve in blood pressure response after renal artery stenting (PREFER study). Cardiol J. 2013;20(4):418-22. doi: 10.5603/CJ.2013.0101.
Clinical trial NCT04780633: PRECEDE-PROCEED Model-based Program on Genital Hygiene Behaviors
Official title: The Effects of a PRECEDE-PROCEED Model-based Program on Genital Hygiene Behaviors: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Genital Infection Female
Keywords: Genital hygiene behavior
Women's health
Precede-Proceed model
Health education
Nursing
Lead sponsor: Ataturk University
Sponsor class: OTHER
First posted: 2021-03-03
Enrollment: 120
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The study was conducted to investigate the effect of a training program based on the PRECEDE-PROCEED Model on improving genital hygiene behaviors.It was carried out using experimental research design with pre-test and post-test, randomized and a control group. The study was conducted at Erzurum Saltuklu Family Health Center between June 2017 and January 2018. Of the women with genital infections, 120 women were included in the study, of which 60 were in the experimental group and 60 were in the control group. The data were collected by "Personal Information Form," "Genital Hygiene Knowledge, Attitude and Beliefs, Questionnaire" and "Genital Hygiene Behavior Inventory". In study, genital hygiene training intervention prepared according to the Precede-Proceed model was applied to the women in the experimental group. The women in the experimental group were measured at three different times: pre-test before training, post-test through training completition, and follow-up test after 4 weeks. The women in the control group did not receive any training intervention, the pre-test at the first encounter in the family health center and the post-test 5 weeks later.


Eligibility criteria: Inclusion Criteria:

* Between the ages of 18-49,
* married,
* At least primary school graduate,
* No mental and communication problems,
* No chronic disease,
* Non-pregnant.

Exclusion Criteria:

* Women who have entered menopause,
* Women who had received any training on genital hygiene before

Primary outcomes:
measure: H1 hypothesis: PRECEDE-PROCEED training-based program affects on improving genital hygiene behavior.
timeFrame: 5 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Izmir
country: Turkey
facility: Manolya Parlas
state: None Selected
Study officials:
References:
Clinical trial NCT01583933: Essix Retainer vs Hawley Retainer
Official title: PHASE 3 STUDY OF THE EFFECTIVITY OF TWO RETAINERS IN THE DENTAL AND OCCLUSAL STABILITY
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Dental and Occlusal Stability
Keywords: Dental stability
Occlusal stability
Retainers
Lead sponsor: CES University
Sponsor class: OTHER
Collaborators: name: Universidad de Antioquia
First posted: 2012-04-24
Enrollment: 46
Sex: ALL
Minimum age (years): 16
Maximum age (years): 40
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: There are several factors involved in the decision and the retention plan, such as occlusion, patient age, etiology of malocclusion, the speed of the correction, the length of the cusps and health of the tissues involved, relationships inclined planes, size of the arches, harmony of the arches, muscle pressure, interdental proximal contact, cell metabolism and atmospheric pressure. Given these concepts, we need to find grounds to enable decision making with respect to the retainer that offers the best features of containment and stability.

Detailed description: This study aims to assess the stability of tooth position and occlusal retention during treatment with two types of retainers, Essix type retainer and the retainer plate type Hawley in individuals who have completed their growth ending orthodontic treatment at the Faculty of Dentistry University of Antioquia and CES University Medellín

Eligibility criteria: Inclusion Criteria:

* Patients who have stabilized their growth between 16 and 40 who have completed orthodontic treatment and initiate retention treatment
* Who have agreed to participate in the study if elected and to sign informed consent
* Residing in the metropolitan area of Medellin and have the opportunity to attend recall appointments

Exclusion Criteria:

* Periodontal status deteriorated
* missing teeth
* Cleft lip and palate
* History of orthognathic surgery
* History of dental or skeletal open bite
* Presence of some habit oral tongue thrusting, mouth breathing, thumb sucking even after termination of orthodontic treatment

Primary outcomes:
measure: Dental stability
timeFrame: Up to 6 months
Secondary outcomes:
measure: Occlusal stability
timeFrame: Up to 6 months
Other outcomes:
Locations:
city: Medellín
country: Colombia
facility: CES University
state: Antioquia
Study officials:
References:
Clinical trial NCT00404833: Mycophenolate Mofetil in Membranous Nephropathy and Focal Segmental
Official title: A Prospective Randomized Open-label Study to Compare Mycophenolate Mofetil and Corticosteroid With Conventional Immunosuppressive Treatment on Proteinuria in Idiopathic Membranous Nephropathy (MN) and Focal Segmental Glomerulosclerosis (FSGS)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Glomerulonephritis, Membranous
Glomerulosclerosis, Focal
Keywords: idiopathic membranous nephropathy or focal segmental glomerulosclerosis
Lead sponsor: Hospital Authority, Hong Kong
Sponsor class: OTHER_GOV
Collaborators: name: The University of Hong Kong
First posted: 2006-11-29
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a prospective randomized open-label pilot study to investigate the effect of mycophenolate mofetil treatment in patients with abnormal urine protein excretion due to membranous nephropathy (MN) or focal segmental glomerulosclerosis (FSGS). The change in urine protein excretion will be the primary outcome studied. The treatment regimen comprising prednisolone and mycophenolate mofetil will be compared with prednisolone and chlorambucil in MN, and compared with prednisolone in FSGS. The study duration will be 12 months for each patient.


Eligibility criteria: Inclusion Criteria:

* abnormal urine protein excretion and biopsy-proven idiopathic membranous nephropathy or focal segmental glomerulosclerosis

Primary outcomes:
measure: Proteinuria
Secondary outcomes:
measure: Adverse effects
Other outcomes:
Locations:
city: Hong Kong
country: China
facility: Queen Mary Hospital
Study officials:
affiliation: Department of Medicine, Queen Mary Hospital
name: Daniel TM Chan, Prof
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hodson EM, Sinha A, Cooper TE. Interventions for focal segmental glomerulosclerosis in adults. Cochrane Database Syst Rev. 2022 Feb 28;2(2):CD003233. doi: 10.1002/14651858.CD003233.pub3.
citation: von Groote TC, Williams G, Au EH, Chen Y, Mathew AT, Hodson EM, Tunnicliffe DJ. Immunosuppressive treatment for primary membranous nephropathy in adults with nephrotic syndrome. Cochrane Database Syst Rev. 2021 Nov 15;11(11):CD004293. doi: 10.1002/14651858.CD004293.pub4.
Clinical trial NCT05287633: Proton Pump Inhibitors Effects on Dyspepsia During Ramadan Fasting
Official title: Proton Pump Inhibitors Effects on Dyspepsia During Ramadan Fasting
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Dyspepsia
Keywords: fasting
Proton Pump Inhibitors
dyspepsia
Lead sponsor: University of Monastir
Sponsor class: OTHER
First posted: 2022-03-18
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: the objective is to evaluate the interest of proton pump inhibitors in subjects with or without GI symptoms who intend to observe fasting in Ramadan. We will compare the effectiveness of proton pump inhibitors to prevent or reduce the signs of dyspepsia during at least Ramadan as compared to placebo.
Primary purpose: PREVENTION

Brief summary: evaluate the interest of proton pump inhibitors in subjects with or with GI symptoms who intend to observe fasting in Ramadan. The investigators will compare the effectiveness of proton pump inhibitors to prevent or reduce the signs of dyspepsia during Ramadan compared to placebo.

Detailed description: evaluate the interest of proton pump inhibitors in subjects with or with GI symptoms who intend to observe fasting in Ramadan. Investigators will compare the effectiveness of proton pump inhibitors to prevent or reduce the signs of dyspepsia during at least Ramadan compared to placebo.

The study will be conducted at least from April 2019 to at least June 2030.The study is prospective, two parallel groups, randomized controlled and double blind.

Eligibility criteria: Inclusion Criteria:

-

Exclusion Criteria:

* Diagnosed GastroDuodenal Ulcer

Primary outcomes:
measure: Overall symptom relief during the 4 weeks of treatment
timeFrame: 30 days after inclusion
Secondary outcomes:
measure: number of days without dyspepsia
timeFrame: 30 days after inclusion
measure: quality of life assessment
timeFrame: 30 days after inclusion
measure: Patients satisfaction of the treatment
timeFrame: 30 days after inclusion
Other outcomes:
Locations:
city: Monastir
country: Tunisia
facility: Emergency department of university hospital Fattouma Bourguiba of Monastir Monastir, Monastir Tunisia
Study officials:
affiliation: University of Monastir
name: Semir Nouira, Professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05502133: Identification of Acute Intermittent Porphyria Modifying Genes
Official title: Identification of Acute Intermittent Porphyria Modifying Genes
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Acute Intermittent Porphyria (AIP)
Lead sponsor: Icahn School of Medicine at Mount Sinai
Sponsor class: OTHER
First posted: 2022-08-16
Enrollment: 150
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: A member of an AIP family who possesses an AIP pathogenic mutation and is/has been symptomatic (experienced acute attacks). Parents with no known HMBS mutations or heterozygote with familial mutation or a first, second or third degree relative of the above.

Brief summary: This study proposes to identify the predisposing/protective modifying genes that underlie the acute attacks in symptomatic patients with Acute Intermittent Porphyria (AIP), an autosomal dominant inborn error of heme biosynthesis.


Eligibility criteria: Inclusion Criteria:

* Willing and able to give informed consent
* 12 years of age or older
* Willingness to provide blood/saliva and urine samples, and clinical information
* A member of an AIP family, defined as (must meet one of the following):

  1. proband: possesses an AIP pathogenic mutation and is/has been symptomatic (experienced acute attacks in the opinion of the investigator)
  2. Parents (no known HMBS mutations or heterozygote with familial mutation)
  3. First, second, or third degree relative of (a) or (b)

Primary outcomes:
measure: Odds ratios (OR) of the effects of identified modifier genes/variants
timeFrame: Day 1
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Icahn School of Medicine at Mount Sinai
state: New York
Study officials:
affiliation: Icahn School of Medicine at Mount Sinai
name: Robert J Desnick, Ph.D, MD
role: PRINCIPAL_INVESTIGATOR
References: