cyrilzakka/clinical-trials huggingface dataset:
Construction and Evaluation of Airway Leakage Risk Model of Patients With Endotracheal Tube

There are two cases in which the cross-sectional area of the tracheal catheter balloon does not match the cross-sectional area of the patient's airway. If the area of the tracheal catheter balloon is smaller than the cross-sectional area of the patient's airway, the pressure in the balloon reaches 30 cmH2O, and the airway cannot be completely sealed; This will increase the risk of VAP. If the area of the tracheal catheter balloon is significantly larger than the cross-sectional area of the patient's airway, and the pressure in the balloon reaches 30 cmH2O, the airway cannot be effectively sealed; The formation of wrinkles around the airbag also increases the risk of VAP in patients. Therefore, the purpose of this study is to build a risk model of airway leakage of patients' endotracheal tubes, which provides an accurate and objective assessment tool for medical staff, so that medical staff can select the endotracheal tubes purposefully and with emphasis from the beginning of the patients' endotracheal tubes, and reduce the airway leakage or airway mucosal damage of the endotracheal tubes.

Admission number, department, name, gender, height, and weight are obtained through the hospital's electronic medical record management system。 Tidal volume (set Tidal volume), airway peak pressure (real-time data on the ventilator screen), data collection is synchronized with the minimum cuff pressure measurement when the airway is closed.

Eligibility Criteria:
Inclusion Criteria:

Invasive mechanical ventilation; Chest CT imaging examination within 1 year;

Exclusion Criteria:

Patients with pneumothorax Acute respiratory distress syndrome; Chronic Obstructive Pulmonary Disease; Multiple organ dysfunction.
Action Observation Therapy With and Without Acoustic Stimulation in Post Stroke Gait and Balance

Stroke causes the interruption of blood flow towards the brain cells which results in cell death and lead to variety of disorders including deficits in balance and gait. It is well known that it is causing death and disability .The incidence of stroke is increasing in low-income countries because of not using evidence-based practice in health-related conditions in these countries. Action observation training is one of the new developing rehabilitation technique that targets motor learning by the activation of mirror neurons and is the most important approach that targets the motor and functional recovery in stroke patients. A new treatment approach i .e action observation therapy, in which the movements are observed by the patient to provide visual stimulus, then patients are asked to perform those movements. A new approach acoustic stimulation is introduced for improving gait and balance in post stroke patients in which individual patient cadence is used to adjust the beats of sound so that auditory stimulation causes recovery.

Stroke is a medical condition which causes the cessation of blood flow to the brain cells and results in cell death. It is a leading cause of death and disability. Geographical variations play a huge role in the burden for stroke. A stroke survivor experiences a range of symptoms that make it harder for them to carry out regular tasks and raise their risk of falling while walking .The effects of Action Observation Therapy with acoustic stimulation on balance in stroke patients have not been explicitly covered in recent studies. The study intends to evaluate the effectiveness of treatments with evidence for post-stroke balance and gait.

Eligibility Criteria:
Inclusion Criteria:

* Age 40-60 years
* Both male and female
* Any type of stroke
* Walking few steps \[5 or more\] .
* Berg balance score above 21
* Ability to follow the study instructions-Mini mental state examination (MMSE ) score \>24

Exclusion Criteria:

* Patients diagnosed with other neurological diseases
* Tumors or neoplasms
* Cardiopulmonary diseases
* Patient with impaired cognition
* Visual and auditory impairments
Implementation of Problem Management Plus (PM+) in Adult Syrian Refugees in Turkey: Pilot

To implement Problem Management Plus (PM+) in Syrian refugees with this pilot study in Turkey with the aim of informing the definitive RCT about drop-out rates and estimated effect sizes.

The STRENGTHS (Syrian REfuGees MeNTal HealTH Care Systems) study is a 5-year study that started in January 2017 with funding from the European Commission Horizon 2020 scheme and Turkey is one of the sites that this study will be conducted. The main aim of STRENGTHS in Turkey is to evaluate the feasibility, acceptability, effectiveness and cost-effectiveness of the culturally adapted psychological intervention Problem Management Plus (PM+) intervention for adult Syrian refugees in Turkey.

The current trial registration is for the pilot trial to investigate the feasibility and acceptability (e.g., obtain estimates of drop-out rates), to inform a full-scale, definitive randomized controlled trial. Study participants (n=60) will consist of adult Syrian refugees (18 years and older) in Turkey with self-reported functional impairment (WHODAS 2.0 \>16) and elevated psychological distress (K10 \>15.9). Participants will be randomly allocated either to the treatment group who will receive five sessions of PM+ or to the enhanced care-as-usual (E-CAU) group. Participants in the comparison group will receive E-CAU only. The primary outcome will be the decrease in psychological distress from baseline to three-month post-intervention assessment, measured through the Hopkins Symptoms Checklist (HSCL-25).

Eligibility Criteria:
Inclusion Criteria:

* Adults of 18 years or above
* Syrian under temporary protection status
* Arabic-speaking
* Elevated levels of psychological distress (K10 \>15.9) and reduced psychosocial functioning (WHODAS 2.0 \>16)

Exclusion Criteria:

* Acute medical conditions
* Imminent suicide risk or expressed acute needs/protection risks (e.g., a young woman who expresses that she is at acute risk of being assaulted or killed)
* Severe mental disorder (psychotic disorders, substance-dependence)
* Severe cognitive impairment (e.g., severe intellectual disability or dementia)
A Clinical Trial of Anti-Angiogenic Drug Combination Tl-118 for Pancreatic Cancer Patients Who Are Starting Gemcitabine Treatment

TL-118 is an anti-angiogenic drug combination designed for the treatment of cancer. The investigational product Tl-118 comprises of four well-known active components. The therapy is administrated at a unique dosing regimen that was found to be effective and advantageous in terms of safety. The product is formulated as an oral suspension, conveniently administrated by the patients at home and not requiring medical staff assistance. This Phase II clinical trial aims to evaluate the efficacy, safety and tolerability of TL-118 in Gemcitabine treated Pancreatic Cancer patients


Eligibility Criteria:
Inclusion Criteria:

1. Age at least 18 years at enrollment.
2. Metastatic Pancreatic Cancer
3. The patient has histologically or cytologically confirmed pancreatic adenocarcinoma.
4. Patient has measurable disease by (RECIST).
5. Patient is starting standard of care Gemcitabine treatment
6. ECOG performance status ≤ 1
7. Adequate renal function
8. Adequate hepatic function
9. Adequate bone marrow reserve
10. Resolution of prior therapy acute adverse events.
11. Patient is capable of swallowing.
12. Patient's Informed Consent. -

Exclusion Criteria:

1. Hypersensitivity to one or more of the TL-118 active components
2. Known Glucose-6-phosphate-dehydrogenase deficiency (G6PD).
3. CNS or Brain metastases
4. Prior systemic therapy for pancreas cancer
5. Subjects who received any investigational medication, prior local therapy for pancreas cancer , or any significant change in treatment within 1 month prior to screening
6. Concurrent use of any other investigational product
7. Subjects with a clinically significant or unstable medical condition that would preclude safe and complete study participation
8. Use of supplements or complementary medicines/botanicals, except for conventional multivitamin supplements, calcium, selenium and soy supplements.
9. Patient has known historical or active infection with HIV, hepatitis B, or hepatitis C
10. Circumstances likely to interfere with absorption of orally administrated drugs.
11. History of noncompliance to medical regimens or coexisting -
Voluma Filler Agent For The Treatment of HIV-associated Facial Lipoatrophy

The purpose of this study is to test the safety of Voluma and see what effects it has on HIV facial lipoatrophy. The hypothesis is that Voluma will be safe, efficacious and positively impact the quality-of-life in the treatment of facial lipoatrophy in patients with HIV.

HIV facial lipoatrophy (volume loss) is an increasing concern with patients on Highly Active Anti-Retroviral Therapy (HAART) because it affects the quality-of-life and adherence to medication regimen. Treatment of HIV facial lipoatrophy helps to improve patient wellness by removing the social stigma associated with HIV facial lipoatrophy. Currently, there are few medical therapies that can treat HIV facial lipoatrophy and are FDA-approved for this indication. Juvéderm Voluma (Allergan) may benefit patients on HAART because it may provide a more immediate aesthetic enhancement and potentially has fewer adverse effects, which results in a more natural appearing facial enhancement outcome. Voluma is the only agent that is FDA-approved for facial volume loss. We anticipate Voluma having less adverse effects than current FDA-approved drugs for HIV lipoatrophy as Voluma is a hyaluronic acid (HA)-based agent. The benefit of using hyaluronidase to "correct" or "modify" facial HA-based volume therapy is also a benefit for HIV patients, which currently does not exist as a post-injection modification option for other FDA-approved filling agents used to treat patients with HIV facial lipoatrophy. Voluma is currently FDA-approved for correction of age-related volume loss in the midface, and there's no alteration in the chemical or biophysical properties of Voluma that is being used in our proposed study. In addition to conventional injection techniques, we will implement the 'smile and fill' technique pioneered by our clinical research group to achieve better mid-face aesthetic outcomes.

Eligibility Criteria:
Inclusion Criteria:

* Aged 18 years or more with laboratory evidence of HIV-1 infection and have been on HAART therapy for at least 1 (one) year.
* Not to have AIDS (CD4 count \< 250) or AIDS-defining illness.
* Bilateral lipoatrophy corresponding to a visual grade 2 or above in the attached Carruthers Lipoatrophy Severity Scale (CLSS).
* Available and willing to attend study follow-up visits.
* Able and willing to give informed consent.

Exclusion Criteria:

* Any active skin inflammation or infection in or near the treatment area.
* Hypersensitivity to the components of Voluma.
* Previous treatment with Voluma or any other product for facial lipoatrophy within the past year.
* Has known bleeding disorder
* History of keloid formation
* Currently receiving systemic corticosteroids or anabolic steroids
* Currently on known anticoagulants (i.e. aspirin, non-steroidal anti-inflammatory drugs)
* Pregnancy or breastfeeding or anticipating becoming pregnant during the study period.
* Any other excluding factors that, according to the investigator's judgment, would preclude enrollment in the study.
* Any condition that may interfere with ability to comply with study requirements.
Post Market Clinical Follow-Up KeriFlex®

The general objective of this study is to assess the performance and safety of the KeriFlex® silicone joint implant and its associated instruments, used in accordance with the labeling and instructions in force.

The performance and safety of the KeriFlex® joint implant will be established in the short and long term with regard to the life cycle of the implant.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients (age ≥ 18 years)
* Patients who are going to undergo arthroplasty of the metacarpophalangeal or proximal interphalangeal joint using a KeriFlex® implant in accordance with the instructions for use and the labelling in force.
* Patients with rheumatoid arthritis, osteoarthritis or post-traumatic osteoarthritis

Exclusion Criteria:

* Pregnant or breastfeeding women
* Patients with an intellectual disability who cannot follow their surgeon's instructions
* Patients with general surgery contraindications and particularly to the implantation of a KeriFlex® implant
* Patients with acute or chronic, local or systemic infections
* Metacarpal or phalanx destruction or poor bone quality preventing adequate fixation
* Muscle loss, alteration or vascular deficiency in the affected finger
* Patients with significant physical activity involving treated joint
* Children, young growing patients with open epiphyses
Genetics of Primary Ciliary Dyskinesia

This study is designed to study DNA sequencings for mutations in a research genetic test panel of genes (which contains all 32 known and/or published genes associated with PCD). The study aims to show that about 70% of PCD patients have biallelic mutations in one of these genes. This project will enroll patients who have already had a clinical evaluation, and have clinical features consistent with PCD.

The investigators have established a Consortium of 9 geographically-dispersed clinical research sites to study rare disease of the airways, including Primary Ciliary Dyskinesia (PCD). PCD is a genetic disorder with defective mucociliary clearance (MCC), sinus and pulmonary disease with chronic infection, and organs located on the wrong side of the body in about 50% of patients (Kartagener Syndrome). Lung disease occurs early in children with PCD, but establishing a diagnosis remains a major challenge, based on the traditional approaches of using electron microscopy and/or ciliary waveform analysis to define abnormalities of ciliary ultrastructure and/or function.

For this study, blood or buccal samples for DNA will be collected and genetic testing in patients with known or suspected PCD will be performed. This study can include term neonates with respiratory distress of unknown etiology and features of PCD, particular laterality defects (situs inversus or heterotaxy). The key hypothesis for this study is that a genetic test panel of 32 genes will confirm a diagnosis in most patients with PCD.

Eligibility Criteria:
Inclusion Criteria:

* Any patient who has ≥ 2 clinical features (+/- lab) characteristic of PCD, including:

  * Neonatal respiratory distress after term (or near-term) birth
  * and/or laterality defect ( situs inversus or heterotaxy)
  * and/or daily wet cough before 6 months of age
  * and/or middle ear disease
  * and/or chronic nasal congestion before 6 months of age
  * and/or bronchiectasis
  * and/or male infertility due to sperm tail dysfunction
  * and/or low nasal nitric oxide levels (\<77 nanoliters/minute)
  * and/or defective ciliary ultrastructure

Exclusion Criteria:

* Known diagnosis of cystic fibrosis with classic clinical presentation and elevated sweat chloride levels and/or two known disease-causing Cystic Fibrosis transmembrane conductance regulator (CFTR) mutations, or documented primary or acquired immunodeficiency.
* Known explanation for bronchiectasis (and other clinical features), such as α1-antitrypsin deficiency (ZZ or ZS), inflammatory bowel disease or rheumatoid arthritis.
* Any patient who is unwilling or unable to provide consent or to comply with the testing required in this protocol

A participant should not be in the study if they have not had a standard clinical evaluation to address other potential causes of chronic oto-sino- pulmonary disease.
A 26-Week Extension Study of EVP-6124 (Alpha-7 nAChR) as an Adjunctive Pro-Cognitive Treatment in Schizophrenia Subjects on Chronic Stable Atypical Antipsychotic Therapy

This study is being conducted to further investigate the safety of prolonged exposure to EVP-6124 in subjects with Schizophrenia receiving a stable dose of an atypical antipsychotic who completed double-blind treatment on studies EVP-6124-015 and EVP-6124-016.


Eligibility Criteria:
Inclusion Criteria:

* Completion of the Day 182 visit in a previous 26-week double-blind study (EVP-6124-015 or EVP-6124-016).
* Subject has signed informed consent for this extension study, indicating that the subject understands the purpose of and procedures required for the study, before the initiation of any extension study specific procedures. Subjects who are unable to provide informed consent will not be included in the study
* No clinically significant changes in the subject's medical status during the participation in EVP-6124-015 or EVP-6124-016. Any significant changes in health care status and their impact on subject eligibility will be reviewed by the investigator and sponsor on a case-by-case basis.
* In the opinion of the investigator, the extension treatment is in the best interest of the subject.
* Fertile, sexually active subjects (men and women) must use an effective method of contraception during the study. Females and the female partners of male must be surgically sterile (hysterectomy or bilateral tubal ligation), postmenopausal for at least 1 year, willing to practice adequate methods of contraception if of childbearing potential (defined as consistent use of combined effective methods of contraception \[including at least one barrier method\]). Female subjects must have a negative urine pregnancy test predose on Day 1.

Exclusion Criteria:

* Significant risk for suicidal or violent behavior, as determined by the investigator. Significant risk for suicidal behavior is defined as 1) suicidal ideation as endorsed on items 4 and 5 of the Columbia-Suicide Severity Rating Scale (C-SSRS); 2) suicidal behaviors detected by the C-SSRS; or 3) psychiatric interview and examination.
* Adverse events from the previous study (EVP-6124-015 or EVP-6124-016) that have not resolved, are of moderate or greater severity and judged to be possibly related or related to study drug and are thought by the investigator to be contraindications to study participation.
* Any condition which would make the subject, in the opinion of the investigator, unsuitable for the study.
* Female subjects who are pregnant.
* Subjects who received any other investigational treatment during participation in either EVP-6124-015 or EVP-6124-016 other than assigned study medication.
Long-Pulsed Dye Laser and Intense Pulsed Light for Skin Rejuvenation.

The purpose of the trial is to compare clinical efficacy and occurrence of side effects in the treatment of photodamaged skin with Pulsed Dye Laser and Intense Pulsed Light.


Eligibility Criteria:
Inclusion Criteria:

* Mild to moderate bilateral facial photodamage
* Symmetry in the facial area of wrinkles, skin texture, pigmentary changes and telangiectasia
* Fitzpatrick's skin type of Type I, II, or III, without significant tan
* Age \> 40 years
* Able to read and comprehend Danish
* Informed consent agreement signed by the subject
* Willingness to follow the treatment schedule and posttreatment follow-up evaluations
* Willingness to allow photographs of the treated area to be taken for evaluation of efficacy.

Exclusion Criteria:

* Scarring or infection of the area to be treated
* Known photosensitivity
* Presence of a suntan in the area to be treated
* Subjects taken medication known to induce photosensitivity in the previous three months
* Known anticoagulation or thromboembolic conditions
* Subjects taking anticoagulation medication
* Subjects taking Accutane within the past 6 months
* Subjects treated with aspirins or anti-inflammatory drugs
* Subjects who are immunocompromised or have a medical history that is inappropriate for the study per the investigator's clinical judgment.
* Dermabrasion, chemical peel, laser or IPL treatment, or collagen injection therapy in the facial area in the past 12 months.
* Previous formation of hypertrophic scars or keloids
* Subjects who are pregnant or lactating
* Asymmetry in the facial area of wrinkles, skin texture, pigmentary changes and telangiectasia
A Phase 2 Study For Patients With A Physician's Diagnosis Of Rheumatoid Arthritis

The purpose of this study is to determine the effectiveness and safety, over 6 months, of 5 doses of CP-690,550 for the treatment of adults with active rheumatoid arthritis. Five out of seven subjects will receive CP-690,550. One out of seven will receive adalimumab (Humira®) and one out of seven will only receive inactive substances (placebo.)


Eligibility Criteria:
Inclusion Criteria:

* Subjects must have active rheumatoid arthritis
* Subjects must have failed at least 1 disease modifying anti-rheumatic drug (DMARD)
* Subjects must not be currently taking any DMARD other than an antimalarial

Exclusion Criteria:

* Subjects who discontinued any previous TNF inhibitor therapy for either lack of benefit or safety.
* Subjects who previously received adalimumab (Humira®) therapy for any reason.
* Subjects with evidence of blood disorders, chronic infections or untreated tuberculosis
The Effect of Long-pulsed 1064 nm nd: Yag Laser-assisted Hair Removal on Some Skin Flora and Pathogens: an in Vivo Study

1. To evaluate the effect of ND-YAG laser hair removal on some skin flora and pathogens: an in vivo study.
2. To determine the immediate and long term effect of ND-YAG laser on total viable bacterial count, some skin flora and pathogens of laser-assisted hair removal in axilla.
3. To assess the relation between this effect and bromohidrosis.

This Quasi-experimental interrupted time series study will be conducted on 30 female participants who will be recruited from the Dermatology Outpatient Clinic of the Alexandria Main University Hospital.

Four sessions of laser assisted hair removal at 4 weeks intervals (S1, S2, S3 and S4) using long pulsed ND: YAG (Cynosure Elite+™, Westford, USA). The following parameters will be used according to the nature of hair (1064 nm, 15-18 mm spot size, fluence of 24-35 J/cm2, pulse duration 30-40 ms).

4. Swabs will be collected immediately and after each session

Eligibility Criteria:
Inclusion Criteria:

No previous laser hair removal sessions involving axilla. Fitzpatrick skin type III-VI.

Exclusion Criteria:

1. Skin diseases such as atopic dermatitis, psoriasis, fungal or herpetic infections.
2. Systemic diseases such as diabetes or endocrinal dysfunction.
3. Patients receiving immunosuppressive therapy.
4. Pregnant or lactating females.
Modulation of Lactase Expression by a New PPARgamma Ligand in Duodenal Biopsies

This study is designed to assess the effect of a new PPARgamma modulator on the expression and activity of the lactase enzyme in human intestinal epithelial cells. Based on their previous experimental results, the investigators hypothesized that modulating intestinal PPARgamma activity is a new pharmacological mechanism allowing the control of lactase expression and activity in the gut


Eligibility Criteria:
Inclusion Criteria:

* Subjects undergoing gastroduodenal endoscopy for digestive cancer screening
* Subjects undergoing gastroduodenal endoscopy for ulcerative gastroduodenal diseases
* Subjects undergoing gastroduodenal endoscopy for epigastric pains
* Subjects undergoing gastroduodenal endoscopy for gastroesophageal reflux diseases

Exclusion Criteria:

* Subjects with macroscopic duodenal lesions detected at endoscopy
* Subjects suffering from coeliac disease
* Subjects suffering from atrophic gastritis
* Subjects who use anticoagulant
* Pregnancy or breast feeding