louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05521815: Effect of Early Coma Arousal Therapy on Conscious Level Recovery and Cognition in Traumatic Brain Injury
Official title: Effect of Early Coma Arousal Therapy on Conscious Level Recovery and Cognition in Traumatic Brain Injury
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Traumatic Brain Injury With Loss of Consciousness
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2022-08-30
Enrollment: 44
Sex: ALL
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: PURPOSE:

The aim of this study is to investigate the effect of early coma arousal therapy on conscious level and cognitive function in sever traumatic brain injury patients.

BACKGROUND:

Traumatic brain injury (TBI) could be simply defined as an alteration in brain function due to external forces and is considered as one of the leading cause of death and disability worldwide, especially among young adults and the elderly. Current estimates imply that annual incidence of TBI is 50-60 million worldwide, and specifically for Europe and USA, 0.5% of Europeans and 1.1% of Americans are experiencing a TBI each year.

The original scale has since been revised and is known as the Rancho Los Amigos Revised Scale (RLAS-R). One of the limitations of the original eight level scale was that it did not accurately reflect the individuals with higher levels of recovery. Two more levels were added to the initial eight level Ranchos Scale to create a more comprehensive ten level scale named the Rancho Los Amigos Revised Scale (RLAS-R).

Detailed description: The aim of this study is to examine the early effect of coma arousal therapy on Conscious Level Recovery and Cognition in Traumatic Brain Injury. forty two patients will be selected and they will be assigned in to two different group, a study group where will they recieve coma arousal therapy in addition to conventional therapy and a control group where they will recieve only the conventional physical therapy program.

Eligibility criteria: Inclusion criteria:

1. Both genders.
2. Traumatic brain injury with GCS score 3-12.
3. Age range from 20-50 years old.
4. Must be medically stable post trauma 29

Exclusion Criteria:

1. Patient with other neurological deficits or orthopedic abnormalities that causing disability.
2. Patients with pre injury psychiatric disorders.
3. Patients with pre injury cognitive disorders.
4. Patients who performed surgery post traumatic brain injury.
5. Patients not taking the same medications.

Primary outcomes:
measure: conscious level
timeFrame: One and half year
measure: Cognition
timeFrame: One and half year
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Kasr el Aini hospital
Study officials:
References:
Clinical trial NCT06713915: Diagnostic Performance of Contrast-Enhanced Mammography
Official title: Diagnostic Performance of Contrast-Enhanced Mammography in Suspicious Breast Lesions
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Mammography
Keywords: breast cancer
breast ultrasound
contrast enhanced mammography
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
First posted: 2024-12-03
Enrollment: 600
Sex: FEMALE
Minimum age (years): 30
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with breast lesions BI-RADS 4 and above treated at the Breast Surgery Department of Peking Union Medical College Hospital.

Brief summary: Contrast-Enhanced Mammography (CEM) is a functional breast imaging technology. Like magnetic resonance imaging (MRI), CEM neovascularization enhancement can improve cancer detection rates, while lack of enhancement may lead to benign determination. The advantages of CEM are dramatically apparent in women with dense breasts. The purpose of this study was to investigate the additional diagnostic value of CEM added to the standard practice of mammography plus ultrasonography(US) in patients with suspicious breast lesions.

This study was a single-center prospective-retrospective combined observational study. In the prospective part, women with suspected breast abnormalities undergo prospective CEM evaluation, including acquisition of low energy (LE) images and recombined images (RI) showing enhancement, concurrently with breast US. The retrospective part selected the mammography and breast US data of female patients with suspected breast abnormalities who had previous baseline matching.


Eligibility criteria: Inclusion Criteria:

* Breast ultrasound or/and general mammography suggest that the lesion is BI-RADS 4 or above;
* Willing to undergo enhanced mammography examination;
* Agree to perform tumor core needle biopsy or excisional biopsy to confirm pathological diagnosis when necessary.

Exclusion Criteria:

* Allergy to iodinated contrast;
* Pregnant and lactating women;
* Suffering from kidney disease or abnormal kidney function, or undergoing renal dialysis;
* The breast is too large to be completely included in the full-field mammography examination at one time; ○5 Those with breast implants.

Primary outcomes:
measure: lesion biopsy rate
timeFrame: 2 years
measure: breast cancer detection rate
timeFrame: 2 years
Secondary outcomes:
measure: number of BI-RADS score upgrade
timeFrame: 3 years
Other outcomes:
Locations:
city: Beijing
country: China
facility: Department of Breast Surgery,Peking Union Medical College Hospital
state: Beijing
Study officials:
affiliation: Peking Union Medical College Hospital
name: Yanna Zhang, M.D
role: STUDY_CHAIR
References:
Clinical trial NCT05616715: Evaluation of Different Periodontal Plastic Surgery Techniques for Gummy Smile Treatment
Official title: Evaluation of Different Periodontal Plastic Surgery Techniques for Gummy Smile Treatment
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Gummy Smile
Lead sponsor: Egas Moniz - Cooperativa de Ensino Superior, CRL
Sponsor class: OTHER
Collaborators: name: Zimmer Biomet
First posted: 2022-11-15
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Investigating different periodontal surgery techniques to treat gummy smile.

Detailed description: Participants will be subdivided into 3 (three) groups:

1. Patients with upper lip hypermobility - surgery for device implantation in the anterior area of the maxilla;
2. Patients with short teeth and upper lip hypermobility - flap surgery/gingivectomy and device implantation; and
3. Patients who refuse implantation - flap surgery/gingivectomy;

Eligibility criteria: Inclusion Criteria:

* Gummy smile due to two etiologies (combined or isolated);
* Short clinical crown of teeth due to the altered passive eruption;
* Upper lip hyperactivity

Exclusion Criteria:

* Smokers;
* Pregnant or breastfeeding patients;
* Patients with systemic diseases that can affect the result of surgical treatment (such as diabetes, heart diseases and taking blood anticoagulant medication, blood diseases, immunodeficiency disease etc.);
* Cleft lip;
* Craniofacial syndrome;
* Facial alteration surgeries during the study;
* Active orto treatment.

Primary outcomes:
measure: Change in Superior incisors proportion (height x length)
timeFrame: Baseline and week 24
measure: Change in Exposure of central incisors at rest
timeFrame: Baseline and week 24
measure: Change in Periodontal probing
timeFrame: Baseline and week 24
measure: Change in Gengiva exposure at rest and forced smile
timeFrame: Baseline and week 24
measure: Change in Interlabial space at rest
timeFrame: Baseline and week 24
Secondary outcomes:
Other outcomes:
Locations:
city: Almada
country: Portugal
facility: Egas Moniz Cooperativa de Ensino Superior
Study officials:
References:
Clinical trial NCT06520215: Correlation Hand Grip Strength and Walking Distance in Elderly
Official title: Correlation Hand Grip Strength and Walking Distance in Elderly
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coronary Revascularization
Lead sponsor: Universitas Padjadjaran
Sponsor class: OTHER
First posted: 2024-07-25
Enrollment: 46
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CROSSOVER
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Patient above 60 years

Brief summary: Elderly patient post coronary revascularization assessed hand grip strength and changes in six minute walking distance

Detailed description: Coronary artery disease causes muscle dysfunction which leads to decreased muscle fitness due to reduced cardiac output, resulting in reduced oxygen uptake from the blood, and further decreases functional capacity or maximum oxygen uptake. The elderly population is an age group at risk of developing coronary artery disease. Handgrip strength s a good predictor for assessing overall muscle fitness, where handgrip strength assessment with a dynamometer is one method of determining muscle fitness, one of the factors affecting cardiorespiratory fitness, which can be assessed by the 6-minute walk test. This study wants to determine the correlation between handgrip strength and changes in 6-minute walk test after undergoing phase 2 cardiac rehabilitation in the elderly after coronary revascularization and this study also wants to know the predictive value using the parameters studied.

Eligibility criteria: Inclusion Criteria:

* Post coronary revascularization
* MMSE \>= 26 BMI 18.5-25

Exclusion Criteria:

* Comorbid cardiovascular, lung, kidney and metabolic disease
* Frailty Syndrome

Primary outcomes:
measure: Correlation Between Hand Grip Strength and Walking Distance in Elderly Patients
timeFrame: 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Bandung
country: Indonesia
facility: Hasan Sadikin Hospital
state: West Java
Study officials:
affiliation: Padjadjaran University
name: Irma Ruslina Defi
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02578615: Physiotherapy for Chronic Metatarsalgia
Official title: Physiotherapie Bei Chronischer Metatarsalgie - Ein Vergleich Klinischer Parameter Vor Und Nach Therapie gemäß Spiraldynamik®- Konzept
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Metatarsalgia
Lead sponsor: Spiraldynamik AG
Sponsor class: OTHER
First posted: 2015-10-19
Enrollment: 28
Sex: ALL
Minimum age (years): 30
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients with chronic metatarsalgia

Brief summary: The pilot study was conducted in the form of an open prospective single-arm observational study with 28 patients who received physiotherapy at the Spiraldynamik® Med Center in Zurich.

Detailed description: The pilot study was conducted in the form of an open prospective single-arm observational study. The data of 28 patients who received physiotherapy at the Spiraldynamik® Med Center in Zurich was evaluated. The endpoints of Visual Analog Scale Foot and Ankle (VAS FA), Activity Index (AI), plantar and inter-metatarsal pres-sure pain, rearfoot angle and dorsal extension capability of the upper ankle joint were individually compared and analyzed before and after therapy.

Eligibility criteria: Inclusion Criteria:

* main diagnosis: Metatarsalgia
* secondary diagnosis: Hallux rigidus,Hallux valgus, Knick-Senk-Spreizfuß, Hohlfuß
* age 30-75 Jahre, gender both
* chronic ( ≥ 3 month),
* pain ≥ 1 visuell analog scale (VAS)
* no other complementary therapy

Exclusion Criteria:

* local: trauma, fracture, tumore, infectionen
* pain after forefoot - operation
* neurological diseases
* generell: somatoform, pension covet

Primary outcomes:
measure: Visual Analog Scale Foot and Ankle (VAS FA)
timeFrame: 9 weeks
Secondary outcomes:
measure: Activity Index (AI)
timeFrame: 3, 8 weeks
measure: plantar and inter-metatarsal pressure pain - measured dichotom
timeFrame: 9 weeks
measure: rearfoot angle measured in degree °
timeFrame: 9 weeks
measure: dorsal extension capability of the upper ankle joint measured in degree °
timeFrame: 9 weeks
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03392415: The NOrdic-Baltic Randomized Registry Study for Evaluation of PCI in Chronic Total Coronary Occlusion
Official title: The NOrdic-Baltic Randomized Registry Study for Long-term Clinical Evaluation of Adjunction of PCI to Optimal Medical Therapy in Chronic Total Coronary Occlusion
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Chronic Total Occlusion of Coronary Artery
Heart Failure
Angina Pectoris
Keywords: chronic total occlusion
CTO
PCI
percutaneus coronary intervention
Lead sponsor: Aalborg University Hospital
Sponsor class: OTHER
First posted: 2018-01-08
Enrollment: 2000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Randomized registry with option of crossover after 6months
Primary purpose: TREATMENT

Brief summary: Randomized registry for the study of CTO PCI as adjunction to optimal medical therapy.


Eligibility criteria: Inclusion Criteria:

* ≥1 CTO lesion amenable to PCI.
* Stable and stabilized coronary artery disease
* Symptoms (angina pectoris or shortness of breath) and/or signs of reversible perfusion defect by SPECT, PET or MR and/or angiographic/echocardiographic indication of reversible ischemia.
* CTO lesion in a major coronary vessel supplying a significant myocardial territory (vessel diameter usually ≥3mm).

Exclusion Criteria:

* Expected survival \<1 year.
* Renal failure on dialysis.
* Stable non-CTO lesions treated within one month.
* Declined informed consent.
* Regarding CMR: allergy to contrast medium, severe obesity, claustrophobia and certain metallic implants

Primary outcomes:
measure: All-cause mortality
timeFrame: a minimal follow-up of 6 months
measure: Quality of life assessment
timeFrame: 6 months.
Secondary outcomes:
measure: MR perfusion
timeFrame: 6 months
measure: Echocardiography
timeFrame: 6 months
Other outcomes:
measure: Socio-economic
timeFrame: 1 year
Locations:
city: Aalborg
country: Denmark
facility: Aalborg University Hospital
Study officials:
affiliation: Aalborg University Hospital
name: Søren Pihlkjær Hjortshøj, MD
role: STUDY_CHAIR
References:
citation: Rinfret S, Sandesara PB. Reducing Ischemia With CTO PCI: Good News, But Questions Remain. JACC Cardiovasc Interv. 2021 Jul 12;14(13):1419-1422. doi: 10.1016/j.jcin.2021.05.028. No abstract available.
Clinical trial NCT02546115: RCT - Assessing the Benefits of the Use of a Tension Night Splint in Patients With Plantar Fasciitis
Official title: Assessing the Benefits of the Use of a Tension Night Splint in Patients With Plantar Fasciitis, a Single-blinded Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Plantar Fasciitis
Lead sponsor: University Hospitals, Leicester
Sponsor class: OTHER
First posted: 2015-09-10
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To assess whether the provision of a tension night splint (TNS) device has any additional benefit in patients with chronic plantar fasciitis, compared to routine care comprising physiotherapy \& podiatry alone.


Eligibility criteria: Inclusion Criteria:

1. Patients age \>18 with symptoms of plantar fasciitis for \>3 months
2. Diagnostic imaging confirming plantar fasciitis (either US or MRI acceptable)

Exclusion Criteria:

1. Current or previous partial or full-thickness tear of the Achilles tendon or plantar fascia (either clinically suspected or proven on imaging)
2. Current or previous calf muscle injury
3. Previous use of tension night splint
4. Diabetic neuropathy, or other sensory / sensorimotor disturbance
5. Lower limb vascular compromise
6. Fragile skin, or skin wounds on lower leg
7. Subjects with impaired mobility which prevents safe and effective application of the Tension Night Splint
8. Any other condition which it is thought may be aggravated by the use of a tension night splint
9. Subjects unable to give valid consent for the study
10. Subjects who state that they are unable or unwilling to undergo the home-based structured rehabilitation programme as a part of the study process
11. Subjects who are unable to attend the follow-up appointment required at the end of the study

Primary outcomes:
measure: Reduction in pain as assessed by a 0-10 visual analogue scale (VAS)
timeFrame: primary outcome time = 3 months
Secondary outcomes:
measure: improvement in function as assessed by validated PROMs as described below
timeFrame: 3 months - end point
Other outcomes:
Locations:
city: Leicester
country: United Kingdom
facility: University Hospitals of Leicester NHS Trust
Study officials:
affiliation: UHL
name: Patrick Wheeler
role: PRINCIPAL_INVESTIGATOR
References:
citation: Wheeler PC. The addition of a tension night splint to a structured home rehabilitation programme in patients with chronic plantar fasciitis does not lead to significant additional benefits in either pain, function or flexibility: a single-blinded randomised controlled trial. BMJ Open Sport Exerc Med. 2017 Jun 13;3(1):e000234. doi: 10.1136/bmjsem-2017-000234. eCollection 2017.
Clinical trial NCT03419715: Topical Bimatoprost in the Treatment of Migraine
Official title: A Phase IIa Randomized, Placebo-controlled Clinical Trial to Evaluate the Efficacy and Safety of Bimatoprost in the Treatment of Migraine
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Migraine Disorders
Headache Disorders
Keywords: migraine
headache
bimatoprost
Lead sponsor: Manistee Partners
Sponsor class: INDUSTRY
First posted: 2018-02-05
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The study is to assess the effectiveness of topically applied bimatoprost in reducing migraine headache frequency, severity, and duration. It will also assess the effect of topical bimatoprost on quality of life.

Detailed description: Hall, et al. have observed retrospectively that treatment with topical prostaglandin F2 alpha analogs (applied either to the eye or fingernail bed) significantly reduced the frequency, severity and duration of headaches in migraine sufferers, as well as their migraine disability assessment score (MIDAS).

This is a double-blind, placebo-controlled prospective clinical study to determine if the effect of FDA-approved bimatoprost, a prostaglandin F2 alpha analogue, has anti-migraine activity when administered topically to people suffering from migraine.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of migraines based on International Classification of Headache Disorders (ICHD) II criteria and experiencing headaches for 4 or more days per month.

Exclusion Criteria:

* Significant liver or renal dysfunction,
* On treatment for inflammatory bowel disease, medication over-use for headaches according to the ICHD II criteria,
* Use of antipsychotics in the past month,
* Recent (in the past six months) history of alcohol or drug abuse,
* Allergy to bimatoprost and its compounds,
* Severe comorbid psychiatric illness,
* Severe infection,
* Malignancy,
* Severe cardiovascular disease,
* Neurodegenerative disorders,
* Pregnancy and lactation, and
* Sexually active women of child bearing age who do not use any method of contraception.

Primary outcomes:
measure: Reduction in Headache Frequency
timeFrame: 12 weeks
Secondary outcomes:
measure: Intensity of Headaches
timeFrame: 12 weeks
measure: Duration of Headaches
timeFrame: 12 weeks
measure: Migraine Disability Assessment Scale (MIDAS)--Quality of Life
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: CTI Clinical Trial and Consulting Services
state: Ohio
city: Warwick
country: United States
facility: Omega Medical Research
state: Rhode Island
Study officials:
affiliation: Manistee Partners
name: Robert L Bratzler, PhD
role: STUDY_CHAIR
References:
citation: Hall LB et al. The Effect of Topical Prostaglandins on Migraine Headaches. Poster Presentation at the Association for Research in Vision and Ophthalmology Annual Meeting, May 2017.
Clinical trial NCT05337215: The Effect of Postpartum Kangaroo Father Care on Paternal Attachment
Official title: The Effect of Postpartum Kangaroo Father Care on Paternal Attachment: A Randomized Controlled Study Turkey Sample
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Nursing Caries
Lead sponsor: Hitit University
Sponsor class: OTHER
First posted: 2022-04-20
Enrollment: 90
Sex: MALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Objective: This study was conducted in a randomized controlled manner to determine the effect of kangaroo care (KC) on paternal attachment (PA).

Detailed description: Objective: This study was conducted in a randomized controlled manner to determine the effect of kangaroo care (KC) on paternal attachment (PA).

Design: The data for the study were collected using the introductory information form (IIF) and the father-infant attachment scale (FIAS). T test, Mann Whitney U test and Kruskal Wallis test were used for statistical analysis.

Participants and setting: A total of 90 fathers, including 45 in the intervention group and 45 in the control group who met the inclusion criteria of the study were included randomly.

Keywords: Kangaroo care; father; paternal attachment; Turkey.

Eligibility criteria: Inclusion Criteria:

* fathers who are aged 18 and 50,
* married,
* voluntarily agree to participate in the study,
* have healthy babies,
* live with their babies.

Exclusion Criteria:

* a history of chronic psychiatric illness
* antipsychotic medication use
* babies with premature / low birth weight / congenital anomalies

Primary outcomes:
measure: Father-Baby Attachment Scale The Turkish version
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Corum
country: Turkey
facility: Fatma Yıldırım
state: Çorum
Study officials:
References: