louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04174482: Morphological and Functional Evaluation of Adult Flat Foot Before and After Corrective Surgery
Official title: Pilot Study of Morphological and Functional Evaluation of Adult Flat Foot by Weight Bearing CT and Gait Analysis Before and After Corrective Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Flat Feet
Lead sponsor: Istituto Ortopedico Rizzoli
Sponsor class: OTHER
First posted: 2019-11-22
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Morphological weight bearing computed tomography parameters and gait analysis can implement the evaluation of the flat foot. Weight bearing CT is useful to verify the severity of the 3D deformities typical of flat foot, while kinematic and kinetic variables of gait is able to quantify the functional improvements of the foot after surgery.


Eligibility criteria: Inclusion Criteria:

* patients with idiopathic flat foot with indication for corrective surgical treatment according to Grice (arthrodesis of the subtalar joint)
* age between 18 and 65 years
* BMI less than 40
* signature of informed consent.

Exclusion Criteria:

* patients with severe alterations or other pathologies affecting the foot and lower limb
* severe vascular and neurological systemic diseases
* systemic diseases that can compromise bone consolidation

Primary outcomes:
measure: Weight bearing computed tomography parameter
timeFrame: change from baseline at 6-months
measure: Gait Analysis parameter
timeFrame: change from baseline at 6-months
Secondary outcomes:
measure: Pain clinical examination parameter
timeFrame: pre-operative phase and at a 6-months follow-up from the intervention
measure: Posture clinical examination parameter
timeFrame: pre-operative phase and at a 6-months follow-up from the intervention
measure: Function clinical examination parameter
timeFrame: pre-operative phase and at a 6-months follow-up from the intervention
Other outcomes:
Locations:
city: Bologna
country: Italy
facility: Istituto Ortopedico Rizzoli
Study officials:
References:
citation: Burssens A, Peeters J, Buedts K, Victor J, Vandeputte G. Measuring hindfoot alignment in weight bearing CT: A novel clinical relevant measurement method. Foot Ankle Surg. 2016 Dec;22(4):233-238. doi: 10.1016/j.fas.2015.10.002. Epub 2015 Oct 30.
citation: Buldt AK, Levinger P, Murley GS, Menz HB, Nester CJ, Landorf KB. Foot posture is associated with kinematics of the foot during gait: A comparison of normal, planus and cavus feet. Gait Posture. 2015 Jun;42(1):42-8. doi: 10.1016/j.gaitpost.2015.03.004. Epub 2015 Mar 12.
citation: Leardini A, Benedetti MG, Berti L, Bettinelli D, Nativo R, Giannini S. Rear-foot, mid-foot and fore-foot motion during the stance phase of gait. Gait Posture. 2007 Mar;25(3):453-62. doi: 10.1016/j.gaitpost.2006.05.017. Epub 2006 Sep 11.
Clinical trial NCT03919682: Promoting Early Detection of Breast Cancer in Rural Rwanda: Impact of Community Health Worker and Nurse Training
Official title: Promoting Early Detection of Breast Cancer in Rural Rwanda: Impact of a Community Health Worker and Health Center Nurse Training Program
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Keywords: early detection
Rwanda
Lead sponsor: Brigham and Women's Hospital
Sponsor class: OTHER
Collaborators: name: Breast Cancer Research Foundation
name: University of Pennsylvania
name: Partners in Health
name: Ministry of Health, Rwanda
First posted: 2019-04-18
Enrollment: 1203
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This project proposes a pilot intervention in Burera District to train rural Rwandan community health workers (CHWs) in breast awareness, and to train primary care nurses at rural health centers in the assessment and management of breast complaints, with a focus on when patients must be urgently referred for more advanced evaluation. The project will randomize health centers to receive the intervention and will evaluate the impact of these trainings on nurse and CHW knowledge and skills. In order to help Rwanda prepare for national early detection efforts, the investigators will also assess the impact of these trainings on patient volume at the health center level, and visits and further diagnostic testing at the district hospital level. The investigators will also examine the impact on the length of diagnostic delays experienced by patients with a breast problem. Among those patients diagnosed with breast cancer, the investigators will also assess their stage at diagnosis.


Eligibility criteria: Inclusion Criteria

* Community health workers or health center nurses affiliated with a designated intervention health center
* Interested in participating

Exclusion Criteria

* Not interested in participating
* Not available for training

Primary outcomes:
measure: Health center nurse knowledge
timeFrame: up to 6 months
measure: Community health worker knowledge
timeFrame: up to 6 months
measure: Health center nurse clinical skills
timeFrame: up to 16 months
Secondary outcomes:
measure: Health center volume
timeFrame: 30 months
measure: District hospital referrals
timeFrame: 30 months
measure: Breast ultrasounds
timeFrame: 30 months
measure: Breast biopsy
timeFrame: 30 months
measure: Patient delays
timeFrame: 24 months
measure: System delays
timeFrame: 24 months
measure: Breast cancer detection rate
timeFrame: 30 months
measure: Breast cancer stage
timeFrame: 30 months
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05068882: Impact of Oral Diets on Postoperative Fluid Collection
Official title: Impact of Preoperative Oral Diets on Postoperative Fluid Collection After Axillary Lymphadenectomy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Postoperative Complications
Lead sponsor: Stanley Dudrick's Memorial Hospital
Sponsor class: OTHER
First posted: 2021-10-06
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 4 arm randomized study
Primary purpose: TREATMENT

Brief summary: Patients after the surgical removal of axillary lymphnodes suffers from prolonged fluid collections. The aim of the study is to assess the impact of oral immunonutrition and high-protein diets on the reduction of fluid collection.

Detailed description: Patients after the surgical removal of axillary lymphnodes suffers from prolonged fluid collections, which requires either prolonged drainage or multiple punctuations. The aim of the study is to assess the impact of oral immunonutrition and high-protein diets on the reduction of fluid collection.

Eligibility criteria: Inclusion Criteria:

* confirmed breast cancer or melanoma
* scheduled surgery with axillary lymph nodes resection
* informed consent
* eligible for surgery

Exclusion Criteria:

* benign disease
* no consent

Primary outcomes:
measure: Fluid collection
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Kraków
country: Poland
facility: Maria Sklodowska-Curie National Cancer Institute
state: Malopolska
city: Skawina
country: Poland
facility: Stanley Dudrick's Memorial Hospital
Study officials:
affiliation: Stanley Dudrick's Memorial Hospital
name: Stanislaw Klek, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01164982: Investigation Evaluating Handling of Mepitel® One Used in Acute Wounds in Home Care
Official title: An Open Non-controlled Proof of Concept Investigation Evaluating the Handling of a Soft Silicone Wound Contact Layer, Mepitel® One Used in Acute Wounds in Home Care
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Acute Wounds
Lead sponsor: Molnlycke Health Care AB
Sponsor class: INDUSTRY
First posted: 2010-07-19
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: The primary objective is to evaluate the handling of Mepitel® One when used in acute wounds in home care.

Secondary objective is to evaluate the comfort, conformability, stay-on ability, pain at removal, transparency of dressing and adverse events.

Detailed description: The investigation is designed as an open, non-controlled, proof of concept investigation. Subjects with acute wounds at one centre will be included. Each subject will be followed once a week for 3 weeks or until healing if that occurs earlier. All dressing changes will be done according to clinical routine and registered in a dressing log. Cover dressing will be used when needed according to clinical routine.

A total of 10 subjects will be enrolled provided that they fulfil all the inclusion criteria and none of the exclusion criteria and have signed and dated the written informed consent.

The subjects will be consecutively allocated to a subject code.

At baseline, subject characteristics will be registered together with subject status of health, wound history and wound status, wound characteristics and current treatment of the wound.

The following variables will be measured as follows:

Eligibility criteria: Inclusion Criteria:

1. Acute wounds/burns
2. Male or female, 18 years and above, both in- and outpatients.
3. Signed Informed Consent Form

Exclusion Criteria:

1. Wound size above 21x24.5 cm
2. Subject not expected to follow the investigation procedures
3. Subjects previously included in this investigation
4. Subjects included in other ongoing clinical investigation at present or during the past 30 days

Primary outcomes:
measure: to evaluate the handling of Mepitel® One when used in acute wounds in home care.
timeFrame: once a week for 3 weeks or until healing
Secondary outcomes:
measure: to evaluate the comfort, conformability, stay-on ability, pain at removal, transparency of dressing and adverse events.
timeFrame: once a week for 3 weeks or until healing
Other outcomes:
Locations:
city: Hamburg
country: Germany
facility: Chir-Praxis
state: Hamm
Study officials:
affiliation: Chir-Praxis, Hamburg
name: Hans J Höning, Dr
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00964782: The Effects of Sildenafil on Exercise Function and Capacity in Patients With Fontan Circulation
Official title: The Effects of Sildenafil on Exercise Function and Capacity in Patients With Fontan Circulation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Fontan Circulation
Keywords: Fontan
sildenafil
exercise capacity
Patients with Fontan Circulation
Lead sponsor: Milton S. Hershey Medical Center
Sponsor class: OTHER
Collaborators: name: Children's Miracle Network
First posted: 2009-08-25
Enrollment: 17
Sex: ALL
Minimum age (years): 6
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The study will test the hypothesis that a single dose of sildenafil can increase the exercise capacity of pediatric patients with a Fontan Circulation.


Eligibility criteria: Inclusion Criteria:

* Age 6-17 years
* Male or female
* Possess Fontan Circulation

Exclusion Criteria:

* Severe heart failure (New York Heart Ass. functional class IV)
* Evidence of Fontan pathway obstruction
* History of exercise-induced severe arrhythmias
* Pregnancy (known or suspected)
* Orthopedic limitations that prevent ambulation on a treadmill
* Use of nitroglycerin
* Herbal medications

Primary outcomes:
measure: The Change in Exercise Capacity Measured Via Maximum Oxygen Consumed During Exercise (VO2)
timeFrame: baseline to 1 hour
measure: The Change in Exercise Capacity Measured Via Exercise Time
timeFrame: baseline to 1 hour
Secondary outcomes:
measure: The Change in Exercise Capacity Measured Via Maximum Heart Rate
timeFrame: Baseline to 1 Hour
measure: The Change in Exercise Capacity Measured Via Minimum Oxygen Saturation Levels.
timeFrame: Baseline to 1 Hour
measure: The Change in Exercise Capacity Measured Via Metabolic Equivalents of Task (METs).
timeFrame: Baseline to 1 hour
Other outcomes:
Locations:
city: Hershey
country: United States
facility: Penn State Hershey Medical Center
state: Pennsylvania
Study officials:
affiliation: Milton S. Hershey Medical Center
name: Devyani Chowdhury, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00733382: Effect of Dexamethasone on Migraine Headache
Official title: The Effect of Dexamethasone in the Attack of Migraine Headache and to Prevent of Its Relapse After Discharge From Emergency Department: a Randomized, Double-Blind, Controlled Trial.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Migraine Headache
Keywords: migraine
dexamethasone
dihydroergotamine
Lead sponsor: Shiraz University of Medical Sciences
Sponsor class: OTHER
First posted: 2008-08-13
Enrollment: 30
Sex: ALL
Minimum age (years): 15
Maximum age (years): 40
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Dexamethasone is a safe and cheap abortive therapy for migraine headache. The effect of it is never evaluate and not correlate with the effect of popular anti migraine medication such as dihydroergotamine. The investigators proposal is to compare its effect with dihydroergotamine.


Eligibility criteria: Inclusion Criteria:

1. Migraine attack according to international headache society criteria
2. Migraine without aura; at least 5 attack with mean duration of 4 to 72 hours and 2 of following:

   * Unilateral
   * Pulsatile
   * Severe enough to impair daily activity
   * Aggravate with walking and climbing, also 1 of following:

     * Nausea and or vomiting
     * Photophobia and phonophobia, and not contributed to other headache.
3. Migraine with aura; at least 2 attacks with 3 of following:

   * One reversible aura
   * Aura became apparent at least in 4 minutes
   * Aura not lasting more than 60 minutes
   * Headache develops in less than 60 minutes after aura

Exclusion Criteria:

1. Hypertension
2. Ischemic heart disease
3. Basilar migraine with sign and symptoms such as:

   * Diplopia
   * Ataxia
   * Dysarthria
   * Dysphagia
   * Weakness
   * Sensory disorder
   * Drowsiness
4. Peripheral vascular disease
5. Sepsis
6. Age more than 40 and less than 15 year old
7. Pregnancy
8. Use of triptans and ergots derivatives in past 24 hours

Primary outcomes:
measure: to evaluate the efficacy of dexamethazone in abortive therapy of migraine attack and prevent of recurrence
Secondary outcomes:
Other outcomes:
Locations:
city: Shiraz
country: Iran, Islamic Republic of
facility: Peyman Petramfar
state: Fars
Study officials:
References:
Clinical trial NCT06648382: Pilot Study of the 'Thriving With PMDs' Program
Official title: Pilot Test of a Self-Directed Psychotherapy Program for Premenstrual Disorders
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Premenstrual Disorder
Premenstrual Dysphoric Disorder
Keywords: Psychotherapy
Premenstrual disorder
Premenstrual dysphoric disorder
Lead sponsor: University of Regina
Sponsor class: OTHER
Collaborators: name: International Association for Premenstrual Disorders
First posted: 2024-10-18
Enrollment: 50
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 42
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study is testing a self-help mental health program that was designed to help people cope with the challenges of living with a premenstrual disorder. Individuals with a premenstrual disorder - either premenstrual dysphoric disorder or premenstrual exacerbation of depression - will track their daily symptoms for two menstrual cycles before they complete the program, throughout the two-cycle program, and for an additional two cycles after accessing the program. This will allow the research team to compare their symptoms before and after accessing the program.


Eligibility criteria: Inclusion Criteria:

* Ages 18-42
* Either meeting diagnostic criteria for premenstrual dysphoric disorder (to be confirmed by researchers through daily symptom ratings for two menstrual cycles) or major depressive disorder with perimenstrual exacerbation (i.e. at least a 30% increase in 4 symptoms in the perimenstrual phase)

Exclusion Criteria:

* Taking oral contraceptives
* Currently in psychotherapy

Primary outcomes:
measure: Pre-to-post changes in perimenstrual Daily Record of Severity of Problems (DRSP) score (range of scores = 24-144)
timeFrame: Baseline, 1 month post-intervention, 2 months post-intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Regina
country: Canada
facility: University of Regina
state: Saskatchewan
city: Regina
country: Canada
facility: University of Regina
state: Saskatchewan
Study officials:
References:
Clinical trial NCT05540782: A Study of Cognitive Health in Survivors of Prostate Cancer
Official title: Prostate Cancer Survivorship and Cognitive Health (PRO-HEALTH)
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Prostate Cancer
Survivorship
Keywords: Cognitive health
Quality of Life
22-223
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
First posted: 2022-09-15
Enrollment: 200
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients from Memorial Sloan Kettering Cancer Center (MSK) and the Ralph Lauren Center (RLC), an MSK-affiliated Harlem community clinic.

Brief summary: The purpose of this study is to collect information that may help the researchers understand the relationship between prostate cancer survivors' experiences of cancer-related cognitive dysfunction (CRCD) and their other conditions (co-morbid factors), including anxiety, depression, and insomnia. The researchers will also find out how additional things may contribute to CRCD, including social factors, the characteristics of participants' prostate cancer, and the type of cancer treatment or other medications they received.


Eligibility criteria: Inclusion Criteria:

* English-speaking
* Age 18 years or older
* History of histologically documented PC of any stage
* No evidence of PC Disease

Exclusion Criteria:

* \<1 month since completion of surgery, radiation, chemotherapy, or ADT
* Diagnosis of Alzheimer's disease, vascular dementia, Parkinson disease, or other organic brain disorder
* Score \>10 indicative of dementia on Blessed Orientation Memory Concentration

Primary outcomes:
measure: number of participants with co-morbid symptoms
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Basking Ridge
country: United States
facility: Memorial Sloan Kettering Basking Ridge
state: New Jersey
city: Middletown
country: United States
facility: Memorial Sloan Kettering Monmouth
state: New Jersey
city: Montvale
country: United States
facility: Memorial Sloan Kettering Bergen
state: New Jersey
city: Commack
country: United States
facility: Memorial Sloan Kettering Cancer Center Suffolk - Commack
state: New York
city: Harrison
country: United States
facility: Memorial Sloan Kettering Westchester
state: New York
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
city: Uniondale
country: United States
facility: Memorial Sloan Kettering Nassau
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Kevin Liou
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00005382: Sources of Variability in Peak Expiratory Flow
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Asthma
Lung Diseases, Obstructive
Chronic Obstructive Pulmonary Disease
Lead sponsor: National Heart, Lung, and Blood Institute (NHLBI)
Sponsor class: NIH
First posted: 2000-05-26
Sex: MALE
Maximum age (years): 100
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no

Brief summary: To provide information necessary for the development of standards for peak expiratory flow (PEF) test performance in populations studies.

Detailed description: BACKGROUND:

While PEF has routinely been applied in the diagnosis and management of asthma, scientists were finding new applications for PEF as both a clinical and epidemiologic tool for following individuals with pulmonary diseases, studying the natural history of chronic obstructive pulmonary disease, and evaluating the impact of environmental exposures on lung function. Yet the standardization of the PEF measurement lagged behind its application.

The little attention paid to the performance characteristics of the PEF maneuver contrasted sharply with the efforts to standardize measurement procedures for FEV1 and FVC. The American Thoracic Society devoted a great deal of attention to studying these measures and published guidelines for the standardization of their measurement. These guidelines included detailed protocols for calibrating equipment, administering the tests, determining reproducibility, and interpreting results.

The research provided data on the optimal number of trials per test session, the difference between a PEF performed during a full forced expiratory effort and that resulting from a short blast, the impact of test supervision on test performance, and the reproducibility of the PEF measurement.

DESIGN NARRATIVE:

A baseline survey of ventilatory function was performed using spirometry. PEF was measured daily with a mini-Wright Peak Flow Meter over a period of several weeks in a study of 201 normals (staff, faculty and graduate students at the University of Massachusetts Lowell). Serial PEF data were collected on a group of mild asthmatics identified in a local occupational medicine clinic. Finally, performance characteristics were examined in serial PEF data from two existing occupational cohort studies.

The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.

Eligibility criteria: No eligibility criteria

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: