cyrilzakka/clinical-trials huggingface dataset:
Use of Mobile Teledermatology in the Care of Acne Patients

The purpose of the present study is to determine whether a mobile teledermatology care model can achieve better clinical outcomes as compared to conventional, outpatient care for the management of severe acne treated with isotretinoin.

The superiority of mobile care in comparison to conventional, outpatient care will be investigated regarding

1. effectiveness: Global evaluation Acne (GEA) score -response at week 24
2. safety: drop out rates and medication side effects
3. overall patient satisfaction with acne care and therapy
4. overall physician satisfaction with mobile acne care


Eligibility Criteria:
Inclusion Criteria:

Female or male, aged 12 to 30 years

* with facial acne
* requiring systemic isotretinoin treatment (GEA-Score: 3-5)
* with basic handy skills
* with a signed consent form

Exclusion Criteria:

* Pregnancy or lactation period
* Withdrawal of informed consent
* Non-compliance, failure to comply with protocol requirements
High Flow Nasal Cannula vs Noninvasive Ventilation in Patients With Hypoxic Respiratory Failure Following Blunt Chest Trauma

to compare high flow nasal cannula against noninvasive ventilation in patients with non-sever blunt chest trauma in improvement of oxygenation, need for intubation and mechanical ventilation within 28 days


Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 y,
* Willing and able to provide written informed consent prior to performing study procedures,
* currently hospitalized and requiring medical care for non-sever blunt chest trauma (abbreviated injury severity scale ≤ 2) SpO2 90% or less while breathing 10 L/min.

Exclusion Criteria:

* Contraindications of noninvasive ventilation (face trauma or surgery, airway obstruction, upper gastrointestinal tract bleeding, disturbed level of consciousness), -smoker
* intubation for any cause other than respiratory cause
Prevalence of Different Etiologies of Ocular Dryness in Patients Previously Diagnosed With Dry Eye Disease in A Sample of Egyptian Patients

Proposed Study Title: Prevalence of Different Etiologies of Ocular Dryness in Patients Previously Diagnosed with Dry Eye

Dry eye disease (DED) is a common chronic multifactorial condition of the ocular surface characterized by failure to produce high quality or sufficient amounts of tears to moisturize the eyes (1) DED can be categorized as "dry eye with reduced tear production (aqueous deficient) and dry eye with increased evaporation of the tear film known as the hyperevaporative type... Although 10% of individuals have aqueous deficient DED, more than 80% have either the hyperevaporative type related to meibomian gland dysfunction (MGD), or a combination of

Eligibility Criteria:
Inclusion Criteria:

* Egyptian people between 20 and 70 years old coming to outpatient clinic BUT\< 10 seconds.. No previous surgery. No previous trauma. Not using eye drops in the last 3 months.

Exclusion Criteria:

Diabetic patients. Patients with rheumatological diseases that may affect ocular surface as RA.
Efficacy & Safety Of Zomig Nasal Spray For Acute Migraine Treatment In Subjects 6 To 11 Years, With OLE

To evaluate the efficacy and safety of zolmitriptan nasal spray (ZNS) in the acute treatment of migraine headache in subjects ages 6 to 11 years.

Part 1: Approximately 20 weeks (includes screening and double-blind treatment).

* Screening will be performed based on the inclusion exclusion criteria specified in the study protocol.
* Randomize approximately 288 subjects into the double-blind crossover phase.

Part 2: Approximately 100 subjects who complete the double-blind crossover phase will enter part 2, a 6 month open-label safety extension (OLE).

Efficacy will be evaluated in the double-blind part of the trial. Safety will be evaluated in both the double-blind and the OLE.


Eligibility Criteria:
Inclusion Criteria

1. Parent or legal guardian is able to provide written informed consent and subject is able to provide assent.
2. Subjects ages 6 to 11 years throughout the double-blind portion of the studyAn established diagnosis of migraine
3. By history, average migraine frequency of ≥ 2 attacks per month lasting on average ≥ 3 hours per attack
4. By history, experiences at least 16 headache-free days per month on average

Exclusion Criteria:

1. History of ischemic or vasospastic heart disease, arrhythmias associated with accessory conduction pathways (eg, Wolff-Parkinson-White syndrome), cerebrovascular disease, hemiplegic or basilar artery migraine, peripheral vascular disease, ischemic bowel disease, uncontrolled hypertension, recent (within 24 hours) or use of another 5HT1 agonist, ergots or ergotamine-containing medications.
2. Any medical condition, including severe hepatic impairment, which, in the opinion of the investigator, may put the subject at increased risk with exposure to zolmitriptan, or may interfere with the safety or efficacy assessments.
3. Had an unacceptable adverse experience following previous use of any 5HT1B/1D agonist drug (in the opinion of the investigator).
4. Had not experienced satisfactory relief from migraine pain during prior treatment with 2 or more adequate courses of triptans.
5. Prior use of any nasal spray (triptan or dihydroergotamine \[DHE\]) for the acute treatment of migraine
6. Disease or anatomic abnormalities of the nasal cavity precluding or complicating the use of ZNS.
Aprepitant Effects on Oxycodone Response

Addressing the issue of opioid dependence and tolerance has public health implications for the treatment of opioid abuse (both heroin as well as pharmaceutical opioids) and for the treatment of pain. Recent preclinical data suggest a role for Substance P (NK-1) receptors in modulating both the acute and chronic response to opioids. The objective of this study is to determine whether pretreatment with aprepitant, a selective neurokinin-1 (NK-1) antagonist can reduce the direct response to an opioid agonist (oxycodone) on measures related to abuse liability and reinforcing effects.

Healthy adult volunteers with histories of illicit opioid use by the intranasal and oral routes will be admitted to this 6-week inpatient, crossover study. They will participate in 15 experimental test sessions, each lasting approximately 6.5 hours, during which they will receive a range of acute doses of aprepitant, including placebo, followed by challenge with oxycodone or placebo (given intranasally or orally). Multi-dimensional outcomes, including physiological (blood pressure, oxygen saturation, pupil diameter), subjective (questionnaires related to mood, abuse liability) and observer ratings will be collected repeatedly throughout each session. Data will be analyzed using parametric approaches to within-subject designs.

Eligibility Criteria:
Inclusion Criteria:

* Recreational user of opioids
* Healthy
* Ages 18-55 years old
* Able to provide informed consent

Exclusion Criteria:

* Ongoing medical or psychiatric condition that would be contraindicated for participation
* Past 30 day use of and P4503A4 inhibitor
Growth of Infants Fed an Elemental Medical Food

Effects on weight will be monitored in healthy infant subjects consuming assigned infant formulas.


Eligibility Criteria:
Inclusion Criteria:

* Singleton, healthy infant
* Gestational age of 37 to 42 weeks
* Birth weight of 2500 grams or greater
* Age between birth and 9 days of age
* Parents agree to not administer mineral or vitamin supplements during the study period
* Parents agree to feed study formula exclusively for the duration of the study

Exclusion Criteria:

* Maternal, fetal or perinatal history which may have adverse effects on growth
* Multiple birth
Follow-up of Persons With Multiple Sclerosis

Multiple sclerosis (MS) is a chronic, progressive and demyelinating disease that affects more than 2.5 million people in the world and is frequently seen in young adults between 20 and 40 years of age, especially in women. Although the exact MS in Turkey is not known, it is estimated as 40/100,000. According to epidemiological studies in recent years, the prevalence and incidence of MS tend to increase. The most common clinical signs and symptoms include loss of sensation in the extremities, partial or total vision loss, acute or subacute motor dysfunction, cognitive impairment, double vision and gait dysfunction.

Currently, MS has no definitive cure. Progressive symptoms related to the disease need to be managed in order to increase and maintain the quality of life of individuals with MS. Pharmacological, physiotherapeutic and psychotherapeutic methods are the most effective effective methods in the management of symptoms. However, the efficacy of these methods has been demonstrated in clinical trials. The outcomes cannot be generalized to the entire MS population because of the inclusion and exclusion criteria that exist in clinical trials. In addition, clinical trials are conducted at a specified time interval (usually a short time interval is selected) and generally, short-term results are provided. In order to better understanding the course of MS, it is of utmost importance that long-term follow-up studies are carried out where as many patients are included and patients are followed from the date of initial diagnosis. The aim of this study is to investigate the change of physical, psychosocial and cognitive characteristics over time and the correlated variables.

The volunteers from MS patients who attend routine control of the MS outpatient clinic of Dokuz Eylül University Hospital will participate in the study. Physical and clinical assessments will be performed by physicians and physiotherapists, and cognitive evaluations will be performed by psychologists with 6-month intervals.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of multiple sclerosis
* Willingness to participate

Exclusion Criteria:

* Severe cognitive, physical, or psychiatric disability that prevent the assessments
Role of Citicoline in Treatment of Newborns With Hypoxic Ischemic Encephalopathy

Citicoline, is a naturally occurring compound and an intermediate in the metabolism of phosphatidylcholine. Phosphatidylcholine is an important component of the phospholipids of the cell membranes. Citicoline is composed of two molecules: cyti¬dine and choline. Both these molecules enter the brain separately and by passing through the blood-brain barrier where they act as substrates for intracellular synthesis of CDP-choline . This drug has been widely used in adults who suffer from acute ischemic strokes for than 4 decades with good results and has been proved to have a very good safety profile as well. It has various therapeutic effects at several stages of the ischemic cascade in acute ischemic stroke.

1. It stabilizes cell membranes by increasing phosphatidylcholine and sphingomyelin synthesis and by inhibiting the release of free fatty acids . By protecting membranes, citicoline inhibits glutamate release during ischemia. In an experimental model of ischemia in the rat, citicoline treatment decreased glutamate levels and stroke size.
2. Citicoline favors the synthesis of nucleic acids, proteins, acetylcholine and other neurotransmitters, and decreases free radical formation Therefore, citicoline simultaneously inhibits different steps of the ischemic cascade protecting the injured tissue against early and delayed mechanisms responsible for ischemic brain injury.
3. citicoline may facilitate recovery by enhancing synaptic outgrowth and increased neuroplasticity with decrease of neurologic deficits and improvement of behavioral performance.

Considering these pharmacologic properties of citicoline, we are planning to see its effects in newborns who have HIE which causes a global acute ischemic changes in developing brain.


Eligibility Criteria:
Inclusion Criteria:

* • Newborn babies having grade 2 and 3 HIE, of both genders delivered in labor room or operation theatre of our hospital.

  * Outdoor patients presenting within 24 hours of delivery

Exclusion Criteria:

* • Outborn babies presenting after 24 hours of delivery.

  * Patients with severe congenital malformations
  * Babies born extremely prematurely (less than 28 weeks)
Perioperative or Adjuvant mFOLFIRINOX for Resectable Pancreatic Cancer

The PREOPANC-3 study is a randomized, multicenter, phase 3 trial. Patients with resectable pancreatic cancer will be randomly assigned (1:1) to 8 cycles of neoadjuvant mFOLFIRINOX followed by surgery and 4 cycles of adjuvant mFOLFIRINOX (arm 1) or to upfront surgery followed by 12 cycles of adjuvant mFOLFIRINOX (arm 2).

The primary objective of the trial is to determine whether perioperative mFOLFIRINOX improves overall survival compared with adjuvant mFOLFIRINOX in patients with resectable pancreatic cancer.


Eligibility Criteria:
Inclusion Criteria:

* Histologically or cytologically (Bethesda 5 or 6) confirmed pancreatic ductal adenocarcinoma.
* Resectable tumor according to Dutch Pancreatic Cancer Group criteria: no arterial contact and venous contact with the superior mesenteric vein or portal vein of 90 degrees or less
* No evidence for metastatic disease
* WHO performance status of 0 or 1
* Ability to undergo surgery and mFOLFIRINOX chemotherapy
* Leucocytes (WBC) ≥ 3.0 x 10\^9/L
* Platelets ≥ 100 x 10\^9/L
* Hemoglobin ≥ 6.0 mmol/l
* Renal function: eGFR ≥ 40 ml/min
* Age ≥ 18 years
* Written informed consent

Exclusion Criteria:

* Prior radiotherapy, chemotherapy, or surgery for pancreatic cancer.
* Prior chemotherapy precluding mFOLFIRINOX.
* Previous malignancy (excluding non-melanoma skin cancer, pancreatic neuroendocrine tumor (pNET) \<2cm, and gastrointestinal stromal tumor (GIST) \<2cm), unless no evidence of disease and diagnosed more than 3 years before diagnosis of pancreatic cancer, or with a life expectancy of more than 5 years from date of inclusion.
* Pregnancy or lactation.
* Serious concomitant systemic disorders that would compromise the safety of the patient or his/her ability to complete the study, at the discretion of the investigator.
Safety and Tolerability of M254 in Healthy Volunteers and Immune Thrombocytopenic Purpura (ITP) Patients

The purpose of this study is to assess safety, tolerability, pharmacokinetics, and pharmacodynamics of M254 after administration of a single ascending dose and repeat doses in healthy volunteers and immune thrombocytopenic purpura (ITP) patients. The pharmacodynamics of the drug will be measured as platelet response in patients with ITP.

The Part A of the study is currently not accepting healthy volunteers as the recruitment for the part A has completed.

Eligibility Criteria:
Key Criteria for Healthy Volunteers: Subject must be between the ages of 18 and 55 years; healthy as indicated by medical history, physical examination, vital signs, clinical laboratory tests, and 12-lead electrocardiogram, and all abnormal findings are assessed as not clinically significant by the Investigator; not pregnant or breastfeeding; and no other clinically relevant abnormalities currently or in their history that the Investigator would deem them ineligible to participate.

Key Criteria for Immune Thrombocytopenic Purpura (ITP) Patients: Patient must be aged ≥18 years and diagnosed with ITP at least 3 months prior to screening, stable maintenance therapy for at least 4 weeks prior to the first study visit, not pregnant or breastfeeding, and no other clinically relevant abnormalities currently or in their history that the Investigator would deem them ineligible to participate.
Comparing Two Modes of Survivorship Care

The main purpose of this study is to research the comparative effectiveness of two potential models of health care to deliver preventive services and chronic care management to the growing population of adult and pediatric survivors of childhood cancer. The central hypothesis is that survivorship care delivered by a subject's primary care doctor after the subject is empowered with individualized follow-up recommendations prepared by a cancer survivor specialist is similar to care provided in a specialty survival clinic.

Although 80% of children with cancer will be cured of their primary disease, at least 70% of survivors will develop chronic medical, neurocognitive, and/or emotional conditions as a complication of their therapy. Most of these conditions are amenable to prevention and early intervention. In response, the Institute of Medicine strongly advised that all cancer patients should receive survivorship care with the following key elements: 1) a summary of previous cancer therapy, 2) individualized life-long screening for potential adverse therapy-related effects, and 3) education regarding desirable health behaviors. However, less than 30% of survivors receive recommended care. There is a tremendous need for research that addresses how to best implement evidence-based recommendations for this population.

Two main health care delivery models have been advocated for survivorship care, but no comparison studies exist. The first model is a specialty survivor clinic, usually at a cancer treatment center. The second model, termed the empowered primary care model, involves patients receiving an individualized "prescription" for follow-up care prepared by a cancer survivor specialist to be implemented by the primary care doctor. Each model poses unique strengths and weaknesses. Specialty survivor clinics can be expensive and geographically inaccessible, can cause anxiety and stress to patients, and can accommodate limited numbers of patients. Primary care doctors may lack adequate expertise and time for these complex patients. Unless we know how these approaches compare with regard to quality of care and risks, advocates and policy makers will be stymied in their efforts to support the health needs of cancer survivors. This study seeks to compare subjects randomized to the empowered primary care model vs. a specialty survivor clinic.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of any malignancy at age \<18 years and reported to Yale-New Haven Hospital or Connecticut Children's Medical Center (CCMC) tumor registry
* Currently alive and cancer-free
* Primary residence within approximately 100 miles of Yale-New Haven Hospital or CCMC
* ≥ 1 year status post completion of all cancer-related therapy
* Elapsed time of less than 12.0 years since diagnosis of malignancy
* Speaking and writing knowledge of English. For subjects \<18 years, at least one parent must satisfy this requirement.
* No previous attendance at the Yale HEROS or CCMC Reach for the STARS survivorship clinics, or other specialty survivorship clinic

Exclusion Criteria:

* n/a
Relationship Between LRG and Periodontal Disease

This study aimed to investigate gingival crevicular fluid (GCF) and serum levels of LRG, interleukin (IL)-6 and tumor necrosis factor (TNF)-α in patients with periodontitis before and after non-surgical periodontal treatment.

Twenty-five stage 3 periodontitis and twenty-five periodontally healthy individuals were enrolled in the study. Clinical periodontal measurements were recorded; periodontitis patients received non-surgical periodontal treatment, and GCF and serum samples were obtained at baseline and at 6 weeks after treatment. LRG, IL-6 and TNF-α were determined by ELISA.

Eligibility Criteria:
Inclusion Criteria:

1. 25-50 years of age
2. having at least 20 natural teeth, excluding third molars
3. having no systemic disease
4. non-smokers
5. criteria for healthy control group: BOP \< 10% and PD ≤ 3 mm without clinical attachment loss or radiographic sign of alveolar bone destruction
6. criteria for stage 3 periodontitis group: interdental CAL ≥ 5 mm at least 2 non-adjacent teeth, PD ≥ 6 mm and radiographic bone loss extending to the mid-third of the root or beyond.

Exclusion Criteria:

1. having any systemic diseases,
2. smoking
3. current pregnancy or lactation
4. a history of periodontal treatment in the past 6 months
5. using antibiotic, anti-inflammatory drugs or any other drugs within the past 6 months.
Modafinil for Smoked Cocaine Self-Administration

Modafinil has been reported to reduce cocaine use in a clinical sample of infrequent users (2 days/week), but the effects of modafinil on cocaine self-administration in the laboratory have not been studied. The present study investigated the effects of modafinil maintenance on cocaine self-administration by frequent users (4 days/week) under controlled laboratory conditions. During this 48-day double-blind, crossover design study, the effects of modafinil maintenance (0, 200, and 400mg/day) on response to smoked cocaine (0, 12, 25, and 50 mg) were examined in nontreatment seeking cocaine-dependent individuals (n = 8).


Eligibility Criteria:
Inclusion Criteria:

1. Smokes cocaine
2. Has patterns of smoked cocaine use in terms of frequency and amount which parallel or exceed those administered in the study.
3. Age 21-50.
4. Able to give informed consent, and comply with study procedures.
5. Normal body weight Within normal weight range (for appropriate frame) according to 1983 Metropolitan Weight tables -

Exclusion Criteria:

1. Current seizure disorder, heart disease or a history of serious adverse effects due to cocaine.
2. Dependence on substances (other than cocaine or nicotine) or a history of dependence on alcohol
3. Request for drug treatment
4. Judged to be noncompliant with study protocol.
5. Current use of any psychotropic medication.
6. Clinical laboratory tests outside normal limits that are clinically unacceptable to the study physician (BP \> 140/90; BUN, creatinine, LFTs \> 3x ULN; hematocrit \< 34 for women, \< 36 for men; pseudocholinesterase deficiency)
7. History of myocardial infarction or ischemia, clinically significant left ventricular hypertrophy, angina, clinically significant arrhythmia, or mitral valve prolapse
8. Currently meeting DSM-IV criteria for all major psychiatric/psychotic disorders other than transient psychosis due to drug abuse
9. Current parole or probation Self-report during interview -
The Effect Of Meditation On Quality Of Life In Women With Breast Cancer And Other Gynecological Cancers

Women with breast cancer and other gynecologic cancers often suffer significant distress and disability from their disease. A practice of meditation-based stress reduction and cognitive-affective-behavioral learning may help women with these conditions decrease their suffering and improve their quality of life.

The objective of this project in women recently treated for breast or other gynecologic cancer is to determine whether an intervention program consisting of group and individual instruction in a meditation-based practice of stress-reduction and cognitive-affective-behavioral learning has the potential for reducing disabling distress and improving quality of life in a population vulnerable to the progression or recurrence of disease. Quality of life will be assessed at 12 months.

Eligibility Criteria:
Inclusion Criteria:

* All women with stage I-III breast or other gynecologic cancer who have received treatment within the preceding year will be eligible for inclusion in the study.

Exclusion Criteria:

* Patients who refuse to participate will be excluded
* Patients with Metastatic cancer are excluded.