cyrilzakka/clinical-trials huggingface dataset:
Surveillance For New Lung Primaries

This clinical research protocol proposes to perform low dose helical computed tomographic (CT) scanning in 250 high-risk patients (125/year for two years) in order to detect lung carcinomas when they are small and subject to effective curative therapies.


Eligibility Criteria:
Inclusion Criteria:

* Asymptomatic

Exclusion Criteria:

* 20 pack year history
USPIO-enhanced and Diffusion-weighted MRI for the Detection of Pelvic Lymph Node Metastases

Preoperative detection of lymph node metastases in patients with prostate or bladder cancer is crucial for selection of the appropriate treatment strategy (surgery, androgen deprivation with/or without radiation therapy or chemotherapy) and thus for patient prognosis. Until now CT or MRI have been the modalities of choice for preoperative staging procedures. However, current morphological assessment of lymph nodes based on size and shape is unable to detect smaller metastases or liable to give false positive results on lymph nodes with reactive hyperplasia. We hypothesize that USPIO-enhanced MRI combined with DW-MRI will be able to detect pelvic lymph node metastases preoperatively with high sensitivity and specificity.


Eligibility Criteria:
Inclusion Criteria:

* Patients with histologically proven prostate cancer (T1-2N0M0 Gleason score 6-10) scheduled for radical prostatectomy or patients with histologically proven bladder cancer (T1-3bN0M0G3) scheduled for cystectomy
* Written informed consent to participate in this trial.

Exclusion Criteria:

* Patients with contraindications for MRI (e.g. pacemaker, metal implants, claustrophobia).
* Patients in a critical cardiovascular state, with risk of decompensation after administration of the USPIO contrast agent.
* Patients with hemochromatosis or an allergy to dextran or iron compounds.
* Pregnant or breast-feeding women.
* Patients who have received gadolinium complexes within 2 days or iron oxide particles within 7 days before MRI.
* Patients who underwent chemotherapy or radiotherapy before surgery.
* Patients whose degree of cooperation is incompatible with carrying out the study.
* Patients with contraindications to Glucagon administration.
The Efficacy of Balance Gaming as an Adjunct to Vestibular Rehabilitation Therapy

Patients with a unilateral vestibular loss often complain of dizziness and imbalance. Movement usually increases these symptoms often resulting in patients avoiding these movements, causing further limitations in their activities of daily living. Vestibular Rehabilitation (VR) involves a series of adaptation and balance exercises to improve symptoms of postural stability. There is evidence that stroke patients gain benefit in their rehabilitation from using gaming consoles (Nintendo Wii Balance) and we believe that similar advantages can be shown for balance patients. We plan a 3 arm study. As there is a considerable wait list for VR, the first arm will receive a Wii console and instructions to use it on the wait list and during VR. The second arm will receive a Wii console and instructions at the end of the waiting list and will use it during VR only and the control group will receive no Wii. All will spend the same time on the wait list and will receive identical assessments and VR

None required

Eligibility Criteria:
Inclusion Criteria:

* Unilateral vestibular loss
* Uncompensated
* Present for \>6 months

Exclusion Criteria:

* Age \<18 years
Estimation of Pentrexin-3 Levels in GCF and Saliva of Patients With Periodontal Disease

Subjects were selected from the outpatient clinic, Department of Oral Medicine and Periodontology, Faculty of Oral and Dental Medicine, Cairo University. Ten healthy control subjects presented with clinically healthy periodontium. Ten patients who had plaque induced gingivitis. Ten patients who had generalized chronic periodontitis. Ten patients who had generalised aggressive periodontitis. Pentraxin-3 levels were evaluated in GCF and saliva of all subjects included in this study with ELISA technique.

The study population consisted of 4 groups of forty patients selected as follows:

Group 1 - Healthy Controls:

Ten healthy control subjects presented with clinically healthy periodontium. Control subjects had to meet the following criteria for inclusion: probing depth less than 3mm, no clinical attachment loss, no bleeding on probing, with Gingival and Plaque index 0-1.

Group 2 - Plaque induced gingivitis patients:

Ten patients who had plaque induced gingivitis characterized by the presence of any of the following clinical signs: redness and edema of the gingival tissue, bleeding upon provocation, changes in contour and consistency, presence of calculus and/or plaque, with no clinical attachment loss nor radiographic evidence of bone loss.

Group 3 - Chronic periodontitis group:

Ten chronic moderate to severe periodontitis patients selected according to the criteria currently adopted by Armitage 1999. Moderate destruction is generally characterized by periodontal probing depths up to 6 mm with clinical attachment loss of up to 4 mm. Advanced destruction is generally characterized by periodontal probing depths greater than 6 mm with attachment loss greater than 4 mm. Radiographic evidence of bone loss is apparent, Increased tooth mobility may be present.

Group 4 - Aggressive periodontitis group:

Ten patients suffering generalized aggressive periodontitis, patients were less than 35 years of age and had generalized interproximal attachment loss affecting at least 3 permanent teeth other than the first molars and incisors with at least one site each with PD and CAL \>5 mm, Attachment loss occurs in pronounced episodic periods of destruction, and there is familial aggregation (subjects were asked if they had at least one other member of the family presenting or with a history of periodontal diseases).

GCF and saliva samples were collected for all patients. Pentraxin-3 levels were evaluated in GCF and saliva of all subjects included in this study with ELISA technique.

Eligibility Criteria:
Inclusion Criteria:

* patients with plaque induced gingivitis
* patients with chronic periodontitis
* patients with aggressive periodontitis

Exclusion Criteria:

* Patients with any systemic disease according to Cornell medical index (1968).
* Patients taking any medications or antibiotics in the last 3 months.
* Current or former smoker patients.
* Pregnant females.
MILTA vs Placebo Use Comparison for the Management of Pain Related to Perineal Scars Following Delivery

The incidence of perineal scars after a pregnancy is high, either related to an episiotomy or to spontaneous perineal tears. These perineal scars can result in acute pain but also in chronic pain for some women. Medical treatment includes level 1 and 2 analgesics and, even for a few women, level 3 analgesic.

The MILTA® uses photons which are emitted with low intensity in the visible and near infrared combining 5 physical principles to reduce pain : 1- The NPCL (Nano-Pulsed Cold Laser) emissions in coherent infrared light, at 905 nanometers; 2- Non-coherent emissions, pulsed by trichromatic RGB CSM diodes (400 to 650 nm); 3- Continuous non-coherent infrared emission monochromatic diodes at 905 nm; 4- A constant circular magnetic field (200 millitesla) equivalent to the terrestrial magnetic field and 5- The effect of magnetic tunnel which potentiates the light propagation. MILTA® treatment has been shown to be effective in various managements of pain, but has never been used in pain related to perineal scars.

This randomized controlled trial aims at assessing MILTA vs placebo to reduce pain related to perineal scars after pregnancy.


Eligibility Criteria:
Inclusion Criteria:

* vaginal delivery less than 24h before inclusion
* perineal scar with pain assessed as \> 3/10 with a numerical scale
* 18-years-old or older
* registration to the French medical system
* speaking and writing French
* written informed consent signed

Exclusion Criteria:

* woman under 18-years-old
* woman under law liberty restriction
* women unable to understand the written informed consent
* no written informed consent signed
* previous perineal surgery
* delivery with a caesarian section
* vaginal delivery with no perineal scar
* vaginal delivery with infected perineal scar
* women with restrictions for the use of level 1 analgesic
* women requiring level 2 or 3 analgesics for other reasons
Quality of Life in Cardiac Pediatric Patients Attending Assuit Univeristy Hospital

Quality of life(QOL) is defined as the individual perception related with their state in life in terms of the cultural structure and system of values in which they live. Their objectives, expectations, standards and concerns, whereas health related quality of life is defined as the patient subjective perception of the impact of their disease or its treatment.(1) Cardiac disease is the most common congenital defect in children, with an incidence of eight in every 1000 live births. Multiple factors have improved and prolonged the lives of children and adolescents with congenital heart disease over the last few decades(2)

Quality of life(QOL) is defined as the individual perception related with their state in life in terms of the cultural structure and system of values in which they live. Their objectives, expectations, standards and concerns, whereas health related quality of life is defined as the patient subjective perception of the impact of their disease or its treatment.(1) Cardiac disease is the most common congenital defect in children, with an incidence of eight in every 1000 live births. Multiple factors have improved and prolonged the lives of children and adolescents with congenital heart disease over the last few decades(2) Diagnosis of a life-threatening illness during a child's formative years can have far-reaching effects that ripple through the family and across a lifetime. Infants with complex CHD experience a range of uncommon and painful events, such as separation from their mother at birth, urgent transfer to specialized intensive care, frequent invasive medical procedures, feeding difficultiesand withdrawal from narcotic pain relief. These earlylife experiences can have profound consequences for the developing child, shaping brain development, the body's immune system and responses to stress.(5) From a neurodevelopmental perspective, children with CHD experience greater difficulties compared with their healthy peers. The risk and severity of neurodevelopmental impairment increases with greater CHD complexity, the presence of a genetic disorder or syndrome, and greater psychological stress. During infancy, the most pronounced difficulties occur in motor functioning. By early childhood, studies show that children with complex CHD have an increased risk of neurodevelopmental impairment, in fine and gross motor skills, and language, attention, executive functioning, emotion regulation and behaviour.(7)

Eligibility Criteria:
Inclusion Criteria:

* - Infants of both sex.
* Age :from 2 years to 18 years.
* Attending Assuit University Children Hospital including NICU, pediatric cardiology department, outpatient clinics.
* Patients diagnosed with congenital heart disease (cyanotic, acyanotic, cardiomyopathy, rheumatic heart).

Exclusion Criteria:

* - patients suspected to have congenital heart but excluded on echo diagnosis. patient with any associated lesions (patients have any congenital anomalies with congenital heart like down syndrome)
Cannabis Use Disorder Treatment Study

The purpose of this study is to test a text-delivered counseling program to stop or reduce cannabis use among young adults (ages 18 to 25).

After being informed about the study and potential risks, participants will complete online screening assessments. Those who are determined to be eligible via online screening will complete a urine drug screen to confirm eligibility. Once eligibility is confirmed, participants will be randomized either to the intervention group or to the wait-list control group. Those who are randomized to the intervention group will receive the 4-week text intervention via smartphone and complete assessments (including urine drug screens) at baseline, 1 month, 3 months, and 6 months. Those who are randomized to the wait-list control group will only complete the assessments (including urine drug screens) at baseline, 1 month, 3 months, and 6 months. Participants who are initially assigned to the wait-list control group can choose to receive the text intervention once their 6-month participation is complete.

Eligibility Criteria:
Inclusion Criteria:

1. 18 to 25 years old.
2. use of cannabis three or more days during a typical week.
3. a score of at least eight on the Cannabis Use Disorder Identification Test-Revised
4. a urine specimen positive for cannabis metabolites.
5. a score of at least two on the Mini International Neuropsychiatric Interview: Version 7.0.2 for DSM-V, Substance Use Disorder
6. must live in Tennessee or Colorado

Exclusion Criteria:

1. substance abuse treatment during the past three months.
2. lack of access to a text-capable phone.
3. unable or unwilling to commit to six months of follow-up.
4. not fluent in English.
Radiographic Changes in the Maxillary Sinus Following Closed Sinus Augmentation

A closed sinus augmentation is performed for dental implant placement.

Patients who are diagnosed as needing sinus augmentation by a closed approach for dental implant placement will be recruited. A cone beam computed tomography (CBCT) study is the standard of care prior to dental implant placement. However, following closed sinus augmentation nothing is known as to the extent of augmentation in the medial to lateral (cross-sectional) dimension. Patients will have a low volume CBCT taken immediately postsurgically, and again at the six-month postoperative visit to determine the dimensional changes in the augmentation. These images will be compared to standard periapical radiographs at the same time points.

Eligibility Criteria:
Inclusion Criteria:

1. Partially edentulous patients (18-85 years of age) requiring maxillary sinus augmentation for dental implant placement.
2. At least 5mm of native bone below the maxillary sinus.
3. Nonsmokers.
4. If diabetic, current HbA1C \<7.0 (less than or equal to 7.0)

Exclusion Criteria:

1. Maxillary sinus disease.
2. Pregnancy or attempting to become pregnant.
3. Diseases that affect bone metabolism.
4. Use of medications known to affect bone metabolism.
5. Tobacco use.
6. Alcoholism or recreational drug use.
7. Diabetic with HbA1C \>7.0 (above 7.0)
Initial Treatment for Acute Bacterial Skin Infections (ABSSSI) Caused by Staphylococcus Aureus

The study investigates the safety and efficacy of PMX-30063 in patients treated for acute bacterial skin and skin-structure infection (ABSSSI).


Eligibility Criteria:
Inclusion Criteria:

1. Have a diagnosis of ABSSSI in which S. aureus is clinically suspected to be the likely pathogen
2. Clinical manifestation of subjects' ABSSSI must include the presence of purulent material suitable for microbiologic culture, Gram stain examination and PCR assay.
3. The ABSSSI must be 75 cm2 or greater in size in order for the subject to be eligible for this study. This includes the primary and surrounding erythema, swelling or induration.
4. Super-infected eczema or other chronic medical conditions (e.g., atopic dermatitis, hidradentitis suppurativa) characterized by prominent signs of inflammation for an extended period even after successful bacterial eradication. (Subjects with an ABSSSI that involves an anatomic location in which there is no evidence of a chronic skin condition are eligible for enrollment.)

Exclusion Criteria:

1. Female patients who are pregnant, lactating (breast milk feeding), or planning a pregnancy during the course of the study.
2. History of peripheral neuropathy of any form or etiology
3. Anticipated need for prolonged antibiotic therapy (i.e., \>8 days)
4. ABSSSI known or suspected to be caused exclusively by Gram negative pathogens or anaerobes (both Gram positive or Gram negative)
5. Diabetic foot infection: defined as a subacute or chronic infection (\> 4 weeks) below the ankle in a patient with diabetic neuropathy
6. Infected burns
7. Known infection with human immunodeficiency virus (HIV) and a CD4 count \< 200/mm3
8. Active hepatitis B or hepatitis C receiving treatment with interferon or other immunosuppressive therapy
Saving Life and Limb: FES for the Elderly With PAD

This study will take the first step to improve public health for millions of Americans with Peripheral Arterial Disease who have extreme difficulty walking due to leg pain. The investigators will assess a proof of concept, home administered, functional electrical stimulation (FES) system to resolve pain, improve walking, and enhance quality of life.

This study will evaluate an innovative approach to reduce the debilitating symptoms of peripheral arterial disease (PAD) and ischemic pain during walking (intermittent claudication) by using a new Functional Electrical Stimulation (FES) system. The investigators hypothesize that combining the FES and walking one hour/day (FES+Walk) will significantly reduce pain during walking, improve locomotion, and enhance quality of life when compared to walking one hour/day (Walk) alone after 8 weeks of intervention.

Eligibility Criteria:
Inclusion Criteria:

Patients who:

1. Are ambulatory, community dwelling adults with evidence of PAD including ankle/brachial index ABI=0.4-0.9
2. Have symptom severity of Fontaine stage II-III
3. Have a score of 24 or higher on the Folstein Mini Mental test
4. Have visible muscle contraction of the plantar flexor (PF) and dorsiflexor (DF) muscles using FES

Exclusion Criteria:

Patients who:

1. Have an electronic implanted stimulator such as pacemaker, defibrillator, deep brain stimulator, spinal cord stimulator
2. Are pregnant
3. Cannot walk without a walker or require human assistance to walk,
4. Present with arthritis or neurological damage resulting in paresis or paralysis of the lower extremity
5. Have skin lesion(s) on the legs where the FES is placed
Otago Exercises, Square Stepping Exercises, Elderly, Fear of Falling

The study was conducted to investigate the effects of Otago Exercise Training and Square Stepping Exercise Training on balance and fear of falling in geriarthric individuals and the superiority of the two exercise training for these parameters. The volunteer individuals participating in the study were randomly divided into 3 groups as otago exercise group, square stepping exercise group and control group with equal number of men and women.

The individuals who participated in study had a homogeneous distribution in terms of age, gender, BMI, height, weight and occupational status in all three groups. However, the number of female individuals was higher in all three groups. In the study, individuals in the exercise training groups received square stepping and otago exercise training 3 days a week for 6 weeks, while individuals in the control group did not receive any training. All three groups were evaluated before and six weeks after the training.


Eligibility Criteria:
Inclusion Criteria:

* 65-75 years old
* Education level at least literate
* Able to walk independently
* Standardized Mini Mental Test Score ≥ 24
* No neurological or lower extremity disease
* Healthy geriatric individuals who agreed to participate in the study

Exclusion Criteria:

* Taking 3 or more medications that may affect cognitive status
* Individuals continuing any exercise/rehabilitation program
* Underwent any surgery for the lower extremities
* Having any neurological-orthopedic problem that may affect gait and balance
Prevalence of Faecal Bacteriophage in Patients With Digestive Symptoms

Define the prevalence of fecal phage carriage in individuals with digestive symptoms (i) Determine the concentrations of infectious fecal phages in the stools of individuals with digestive symptoms (detection by culture)

(ii) Determine fecal phage genome concentrations in the stools of individuals with digestive symptoms (PCR detection)

(iii) Explore factors that could impact fecal phage carriage (patients with digestive symptoms vs. healthy individuals, immunocompromised patients vs. immunocompetent patients)


Eligibility Criteria:
Inclusion Criteria:

* Age between 18 and 60.
* Persons having developed gastrointestinal symptoms justifying microbiological stool testing at the time of hospitalization.
* Person having received full information on the organization of the research and not having objected to the use of this data

Exclusion Criteria:

* Persons covered by articles L. 1121-5, L. 1121-7 and L1121-8 of the French Public Health Code.
* Pregnant or breast-feeding women,
* Minors (not emancipated),
* Adult subject to a legal protection measure (guardianship, curatorship, safeguard of justice),
* Persons of full age who are unable to give their consent.
* Persons deprived of their liberty by a judicial or administrative decision, persons under psychiatric care by virtue of articles L. 3212-1 and L. 3213-1.
The Characteristic of Axial Pain and EEG Analysis of Patients After Laminoplasty

The characteristic of axial pain and EEG analysis of patients after laminoplasty

The characteristic of axial pain after open-door laminoplasty in patients with degenerative cervical spine myelopathy and the correlation with electroencephalogram analysis: a prospective cohort study.

Eligibility Criteria:
Inclusion Criteria:

* Age: 18\~70 years.
* Diagnosed as degenerative cervical spine myelopathy.
* Must receive C3-C7 open-door laminoplasty.
* Agree to join this study and sign the informed consent.

Exclusion Criteria:

* Severe cervical spine kyphosis.
* Cervical spine radiculopathy.
* Laminoplasty with fusion.
* Cervical spine anterior column lesion because of tumor, trauma or infection.
* Severe osteoporosis.
* Morbid obesity.
* patients with mental disorder.
* Pregnancy.
* History of infection within last 3 months.
* Severe nervous system disease.
* Abnormal laboratory report of liver function, kidney function and hematologic system.
* Poor compliance.
* Patients with other surgical contraindications.
* Patients with intemperance or taking drugs.
* Patients who joined other study within the last 3 months.
* Patients with a chief complaint of neck pain (VAS score ≥3 points).
* Left handedness.
Evaluation of a Program to Reduce Smoking in High School Students

Effectiveness of health education regarding the smoking habit is under discussion . Nevertheless, according to the literature, some personal, familiar, cultural, and social factors are considered risk factors for students to become smokers. Probably, a health education intervention integrated in the school program will show a higher rate of effectiveness regarding incidence and prevalence of smoking habit in this age-group .

OBJECTIVE: To evaluate the effectiveness of a health education program to reduce the smoking habit in students.

METHODOLOGY: Quasi-experimental design including all the junior high school students in an educational district in Tarragona (Spain). The sampled schools will be randomised into two groups (experimental and control). All the included students will be monitored for three years.

The health education program will be divided in three interventions: role games and debates (1st year), workshops regarding the family and the social role of smoking (2nd year) , and the analysis of smoking advertising (3rd year). The incidence and prevalence rates will be compared on the experimental and control group, before de beginning of the intervention and at the beginning of each year.


Eligibility Criteria:
Inclusion Criteria:

* Students in high school
* Male and female
* Ages 12 to 16 years old

Exclusion Criteria:

* No Spanish speakers