cyrilzakka/clinical-trials huggingface dataset:
A Study for Lymphocele and Lymphorrhea Control Following Inguinal and Axillary Radical Lymph Node Dissection

Patients undergoing groin or axillary Radical lymph node dissection (RLND) or completion lymph node dissection (CLND, after positive sentinel lymph node biopsy (SLNB) for melanoma or breast cancer were randomized in a controlled trial for surgical dissection technique. Harmonic scalpel dissection were compared with classic dissection in term of lymphocoele and oedema.

The aim of the present study was to assess the value of USS in RLND in groin and axilla in a homogenous group of patients.

In a tertiary academic centre, patients undergoing groin or axillary RLND or CLND after positive SLNB for melanoma, skin cancer, sarcoma or breast cancer were enrolled in a randomized controlled trial for surgical dissection technique. The study was reviewed and accepted by the local ethical committee. Patients were older than 18 years and gave an informed consent. All patients with a past medical history of contralateral lymph node dissection or other cause of lymphedema (previous trauma, deep venous thrombosis, radiotherapy, etc.) were excluded. Patients undergoing both iliac and inguinal lymph node dissections were excluded as well. No patients had distant or in transit metastasis. Patients were randomly assigned using sealed numbered envelopes to one of two arms of the study in a 1: 1 ratio. In the first group the dissection was conducted with USS (Harmonic Focus ®, Ethicon Endo-Surgery (Europe) GmbH) exclusively. In the control group the lymphadenectomy was performed using ligation and monopolar electrocautery. All patients were operated by a dedicated team headed by a single surgeon.

Eligibility Criteria:
Inclusion Criteria:

* All adult patients undergoing groin or axillary Radical lymph node dissection (RLND) or completion lymph node dissection (CLND), after positive sentinel lymph node biopsy (SLNB) for melanoma or breast cancer were included.

Exclusion Criteria:

* Patient with a past medical history of contralateral lymph node dissection or other cause for lymphedema (trauma, deep venous thrombosis, radiotherapy, etc.) were excluded.
Study of the Choroidal and Retinal Thickness in Relation to Axial Length.

The aim of the study is the non-invasive morphological evaluation of the choroid and the retina in relation to the length of the eyeball in healthy, young man and women.

The choroid is responsible for the oxygen supply of the outer retina, hence many diseases that affect the retina are originating from the choroid or at later stages influence the choroid as well. The functional efficiency of the choroid in a healthy subject is important. The thickness of the choroid is a marker for the extent of the vessels inside.

With optical coherence tomography (OCT) non-invasive and non-contact measurement of the choroidal and retinal thickness is possible. Swept-source OCT is one the latest developments of OCTs. Its increase wavelength allows deeper penetration than previous models and allows high resolution imaging.

OCTs are FDA approved machines, they are not considered experimental. The swept-source OCT machine (DRI OCT-1 Model Triton (plus), Topcon, Tokyo, Japan) used in the study is a CE marked commercially available medical device.

The goal of the study is to evaluate the choroidal and the retinal morphology in relation to the length of the eyeball (axial length - AL) in healthy, young adults.

There are several publications on this topic, most of them on asian populations.

In the study healthy, Caucasians in their twenties are recruited to minimize the aging effect on choroidal thickness.

Following informed consent, demographics are recorded, refraction is taken, axial length is measured with IOL Master 500 (Carl Zeiss AG, Germany) then OCT is performed.

Pupil dilation is not necessary. Images are stored digitally by abiding corresponding laws on personal data protection. Results are processed with statistical analysis.

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older, but less than 29 years of age
* Caucasian race
* Signed informed consent

Exclusion Criteria:

* Known epilepsy
* Inability to act
* Media opacity in the eye that would disturb imaging
Physical Activity, Sleep and Age

Ageing is associated with a reduction of physical activity, movement efficiency, and quality of sleep. This leads to reduced health and well being in elderly subjects. Exercise training can increase movement efficiency and quality of sleep.

Objectives:

1. Laboratory validation test of body acceleration based indexes for movement efficiency and quality of sleep;
2. Cross-sectional analysis to assess relations between these indexes and age;
3. Intervention study to assess the effect of exercise training on daily life movement efficiency and quality of sleep in ageing subjects

45 healthy human volunteers, age 50-83 yr, BMI 20-30 kg/m2 are divided in control or intervention group. Subjects that will have practiced fitness activities in the previous year, as well as pregnant or lactating women, will be excluded.


Eligibility Criteria:
Inclusion Criteria:

* Men and women
* Age between 50-85 years
* No fitness activity in the previous year, to amplify training effects on movement efficiency and quality of sleep.
* Body mass index between 20 and 30 kg/m2, obesity limits the training capacity of subjects.

Signed informed consent by the participants

Exclusion Criteria:

* Age below 50 or above 85 years;
* body mass index below 20 kg/m2 or above 30 kg/m2;
* neurologic, cardiologic or invalidating orthopaedic disease;
* pregnancy or lactation.
Evaluation of Pre-Exposure Prophylaxis (PrEP) in Pregnant and Breastfeeding Women

The investigators will conduct an observational cohort study in 1200 pregnant women who will be recruited at the first antenatal care (ANC) visit from the Gugulethu and one additional facility in the Klipfontein-Mitchell's Plain subdistrict of the Metro Region (to be identified in conjunction with provincial and local health authorities) Midwife Obstetric Units in Cape Town (n=600 pregnant women per site). The enrolled women will be followed through 12-months post-delivery.

The objectives of the study are to:

1. Determine the distribution of women across the PrEP cascade:

1. Evaluate the proportion of pregnant and breastfeeding women who initiate PrEP out of all women offered PrEP
2. Evaluate the proportion of pregnant and breastfeeding women who are retained in the PrEP cohort
3. Evaluate the proportion of pregnant and breastfeeding women who initiate PrEP who adhere to PrEP using objective dried blood spot measures and subjective measures of self-reported pill count and adherence
4. Evaluate the proportion of pregnant and breastfeeding women on PrEP (and not on PrEP) who acquire HIV, who transmit HIV to their infant, and who report adverse events 2. Evaluate patient and provider-level factors associated with the PrEP cascade using quantitative and qualitative approaches (including in-depth interviews) 3. Apply an established mathematical model to simulate the impact of improvement in the PrEP cascade on HIV infections averted (maternal and perinatal)

Eligibility Criteria:
Inclusion Criteria:

* \>16 years of age,
* confirmed HIV-negative (using 2 rapid tests,
* confirmed with a 4th generation antigen HIV test;
* lives within 20 km. of the clinic;
* confirmed to be pregnant;
* without psychiatric or medical contraindications to PrEP

Exclusion Criteria:

* Concurrent enrollment in another HIV-1 vaccine or prevention trial;
* medical hospitalization in the past year for any reason;
* receipt of TB treatment in the past 30 days; history of renal disease;
* exhibiting psychotic symptoms (including hallucinations, suicidal or homicidal ideation, or violent behavior),
* currently or history of taking anti-psychotic medications;
* positive Hepatitis B surface antigen test on screening;
* history of bone fracture not related to trauma;
* any other medical, psychiatric, or social condition which in the opinion of the investigators would affect the ability to consent and/or participate in the study.
Accuracy Of Sopro-Life Camera In Comparison With ICDAS II For Detection Of Initial Caries

This study will be conducted to assess diagnostic predictive values of a light induced fluorescence intraoral camera versus those of the visual-tactile assessment method according to modified ICDAS-II criteria in clinical

volunteers patients will be assigned in this study. Each patient should have at least one posterior tooth with pits and fissure discoloration and maximum 4 teeth. The teeth will be evaluated by two diagnostic methods (D), where D1 represents visual-tactile assessment method (ICDAS-II) and D2 represents light induced fluorescence intraoral camera.Three operators, the researcher and the 2 supervisors, from the Conservative Dentistry Department, Faculty of Dentistry, Cairo University, will be the examiners in this study. Each examiner will record the dental findings using both the visual- tactile assessment method and the fluorescent-aided identification method. The visual-tactile assessment method includes the use of mirror, probe under good illumination condition, while the fluorescent-aided identification method will be performed by light induced fluorescence intraoral camera.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged from 15 to 50 years.
* No gender restriction.
* Patients should have an acceptable oral hygiene level.
* Patients must have at least one posterior with fissure discoloration

Exclusion Criteria:

* • Patients with a compromised medical history.

  * Severe or active periodontal disease.
  * Heavy bruxism or a traumatic occlusion.
  * Acute or chronic dental infection.
  * Pregnant or breastfeeding women.
  * Patients with posterior restorations on molars or premolars.
Pregabalin Versus Placebo In The Treatment Of Neuropathic Pain Associated With HIV Neuropathy

The purpose of this study is to evaluate the efficacy of pregabalin compared to placebo in reducing neuropathic pain associated with HIV neuropathy.

Based on DMC interim efficacy analysis results indicating a low probability for success the study was terminated on April 2, 2012; the termination was unrelated to any safety findings that could impact patient health.

Eligibility Criteria:
Inclusion Criteria:

* Men and women, ages of 18 or greater
* Documented evidence of HIV-1 infection
* Documented diagnosis of HIV-associated Distal Symmetrical Polyneuropathy (DSP) with subjective sensory symptom of pain
* Pain starts in the feet

Exclusion Criteria:

* Subject has untreated vitamin B12 deficiency (serum B12 level \<200 pg/ml) or if treated B12 deficiency -treatment is less than 6 months of B12 supplementation (injection or intranasal B12) prior to screening
* Diabetes mellitus requiring regular medical treatment (other than diet and exercise) or HbA1C \>6.9
* Subjects with peripheral neuropathic pain that is not associated with HIV infection; including subjects with conditions such as: Post Herpetic Neuralgia (PHN), Diabetic Peripheral Neuropathy (DPN), familial neuropathies; compression related neuropathy, radicular pain, other infection related neuropathies (eg, leprosy); neuropathy related to: metabolic abnormalities; nutritional factors; vascular insults; inflammation; autoimmune disease; and malignancy
Optimization of Antiretroviral Therapy

The combination antiretroviral therapy (cART) inhibit HIV replication effectively. However, synergy among these drugs has not been well considered. The dose of drugs used as monotherapy is the same as that used in combination therapy. Tenofovir+lamivudine+efavirenz is still the first line regimen of cART in developing countries. The side effects of these drugs are related to the concentration of drugs. Based on our previous data, we aim to evaluate whether reduce the dose of tenofovir and efavirenz could decreasing the incidence of the side effects while not scarifying their virological efficacy.


Eligibility Criteria:
Inclusion Criteria:

* HIV antibody positive
* Chinese nationality
* Naïve to antiretroviral therapy
* Willing to start antiretroviral therapy
* Provision of written informed consent

Exclusion Criteria:

* Pregnant, breastfeeding, or lactating
* Females try to get pregnant during the research period
* Subjects who allergic to any of the research drugs
* Subjects that taking other drugs that known to impact the absorption, distribution, metabolism and excretion of the research drugs
* Any serious or active medical or psychiatric illness which, in the opinion of the Investigator, would interfere with treatment, assessment, compliance with the protocol, or subject safety. This would include any active clinically significant renal, cardiac, pulmonary, vascular, or metabolic (thyroid disorders, adrenal disease) illness, or malignancy
* Medical or psychiatric condition or occupational responsibilities that may preclude compliance with the protocol
* Laboratory blood values:
* Haemoglobin \<9.0 grams/decilitre (g/dL)
* Neutrophil count \<1500/mm3
* Platelet count \<75,000/mm3
* Aspartate aminotransferase or Alanine transaminase \>3 times Upper Limit of Normal (ULN)
* Total bilirubin \>3 times Upper Limit of Normal (ULN)
* Subjects with an estimated creatinine clearance of \<90 mL/minute
Low Dose Interscalene and Infraclavicular Block for Humerus Surgery

Combining interscalene block with infraclavicular block for humerus surgery provides a unique surgical anaesthesia and postoperative analgesia.

Interscalene block provides effective surgical anaesthesia for shoulder and proximal arm surgery. However, sometimes it can be inadequate for distal arm surgery. Combining infraclavicular block with interscalene block may provide a successful surgical anaesthesia for humerus surgery.

Eligibility Criteria:
Inclusion Criteria:

* Patients accepting peripheral nerve block technique for humerus surgery
* Unilateral orthopedic humerus surgery
* 18 years of age or older

Exclusion Criteria:

* Patients refused peripheral nerve block
* Non-cooperate patients
* Neuropathy of any etiology in the affected extremity
Flourishing App: An Evaluation With High School Students

This protocol proposes a well-being program, delivered through an application for mobile devices, based on meditation and positive psychology principles such as human development, the improvement of virtues, quality of life and well-being. The investigators hypothesize that this program offered in mobile application may promote well-being and reduce stress related problems in the participants. Objectives: To evaluate the effectiveness of a well-being program delivered through an application for mobile devices in a sample of high school students. Methods: Sixty high school students will be recruited. The participants will be randomized in two groups of 30 participants each one, half of them in the control group (GC) and the other half to the intervention group (GI).

Introduction: Some very successful stress management programs are based on the principle of Mindfulness. This protocol proposes a well-being program, delivered through an application for mobile devices, based on meditation and positive psychology principles such as human development, the improvement of virtues, quality of life and well-being. In the modern world, young people are connected to new technologies and the use of applications can be a fun way to learn how to cope with stress and promote well-being. In this sense, the investigators hypothesize that this program offered in mobile application can be considered an interesting alternative for high school students who want to reduce symptoms related to stress and also promote well-being. Objectives: To evaluate the effectiveness of a well-being program delivered through an application for mobile devices in a sample of high school students. Methods: Sixty high school students will be recruited. The participants will be randomized in two groups of 30 participants each one, half of them in the control group (GC) and the other half to the intervention group (GI). The GI will participate in the Flourishing App Program, for eight weeks, while the GC will have access to a Control App. Then, after the evaluations, the GC will receive the intervention (Flourishing App Program), while the first group will repeat the use of the Flourishing App Program. Questions will be applied to evaluate the levels of stress and well-being of participants before and after the program and before and after each training period.

Eligibility Criteria:
Inclusion Criteria:

* Complete elementary school

Exclusion Criteria:

-
The Effect of Parenteral Nutrition Supplement on Esophagectomy Patients

Malnutrition is common in esophagus cancer patients, especially after surgery therapy. Whether parenteral supplement with enteral nutrtion is benificial for patients after esophagectomy is controversial, when compared with enteral nutrition alone. In this study, the investigators are to examine the effect of enteral nutrition supplemented with parenteral nutrtion on nutrition status after esophagectomy.


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of esophagus cancer
* Undergo esophagectomy
* Nasoenteral tube is placed or surgical jejunostomy is performed

Exclusion Criteria:

* Contraindication for enteral nutrition or parenteral nutrition
* Malnutrition before surgery ( BMI \> 30 or \< 18.5)
* Hepatic dysfunction preoperatively
* Renal dysfunction preoperatively
* Infection before surgery
* Usage of corticosteroid before surgery
Objective Brain Function Assessment of mTBI/Concussion

This study (Part 3) is designed to build a database including EEG, neurocognitive performance, clinical symptoms, history and other relevant data, which will be used to derive a multimodal EEG based algorithm for the identification of concussion and tracking of recovery.

Injured/concussed subjects will be studied at time of injury, and at 3 follow-up time points following injury. Subjects will come from the sports and other populations of concussed individuals. They will be matched with controls i.e. not head injured subjects who will also undergo the same set of tests and the same time intervals as the injured subjects. An additional pool of uninjured (not head injured) subjects will be collected who will be assessed at a single time point. This data will be used to populate a database for the purpose of deriving a multimodal concussion index.

Eligibility Criteria:
Inclusion Criteria:

For Injured subjects:

1. Having sustained a traumatic closed head injury within 72 hours (3 days) from time of injury at time of BrainScope assessment;
2. GCS 13-15 at time of BrainScope assessment;
3. No hospital admission due to either head injury or collateral injuries for \>24 hours.

For Matched Controls:

1. GCS 15 at time of BrainScope assessment;
2. No prior history of concussion or TBI in the last year.

Exclusion Criteria:

1. Previously enrolled in the BrainScope CAS Studies;
2. Current CNS active prescription medications taken daily, with the exception of medications being taken for the treatment of Attention Deficit Disorder (ADD) or Attention Deficit Hyperactivity Disorder (ADHD);
3. Forehead, scalp or skull abnormalities that prevents headset application or EEG data collection;
4. History of brain surgery or neurological disease;
5. Pregnant women;
6. Subjects who do not speak English (non-English speaking parents are allowed to consent so long as translation of the consent form in their native language is available);
7. Acute intoxication;
8. Evidence of illicit drug usage;

For Injured subjects:

1. Loss of consciousness ≥ 20 minutes related to the concussion injury;
2. Active fever defined as greater than 100ºF or 37.78ºC at time of BrainScope assessment;
3. Evidence of abnormality visible on Computerized Tomography (CT) of the head related to the traumatic event (Note: neuroimaging is not required for enrollment).

For Matched Controls:

1. Any focal neurological signs including aphasia, apraxia, diplopia, facial droop, dysarthria/slurred speech;
2. History of Motor Vehicle Accident (MVA) requiring an Emergency Department visit within the past 1 year.
Safety and Efficacy of High Flow Nasal Canula in Patients With Mild Hypercapnia

Evaluate safety and efficacy of application ( high flow nasal canula) in cases with mild hypercapnia, included 30 patients who were hospitalized in Mansoura University chest department with mild Hypercapnia (Pco2 range 45-60 mmhg and power of hydrogen not less 7.30) of different pulmonary disease categories (Chronic obstructive pulmonary disease acute exacerbation, pneumonia, Interstitial lung diseases, etc).


Eligibility Criteria:
Inclusion Criteria:

* patients with mild Hypercapnia

Exclusion Criteria:

* Excluded cases had age less than 18 years or pediatric group .
* patients with their mental state altered, confused, comatose, severe agitation or non cooperative
* Cases with moderate or severe Hypercapnia
* cases in need for immediate invasive mechanical ventilation
* cases with respiratory rate more than 35 breath per minute.
* cases with Respiratory exhaustion , fatigue , excess use of respiratory accessory muscles
* Shock , hemodynamic instability, post arrest cases,
* cases with facial trauma or severe nasal deformity,
* Patients with sleep breathing disorders or upper airway obstruction
* patients with history of home ventilation prior admission
Correlation Between Driver Gene Abnormalities and Clinicopathological Characteristics and Disease Prognosis in Lymphoma

Correlation Between Driver Gene Abnormalities and Clinicopathological Characteristics and Disease Prognosis in Lymphoma

This trial is a prospective non-interventional observational study. The Chinese patients with lymphoma were included and the study data on driver gene abnormalities, demographic characteristics, clinicopathological characteristics and treatment were collected to evaluate the relevance of efficacy and disease prognosis.

Eligibility Criteria:
Inclusion Criteria:

1. Diagnosed as lymphoma (according to WHO 2017 classification criteria)
2. Life expectancy no less than 3 months
3. Agreeing to sign the written informed consents

Exclusion Criteria:

1. Other malignant tumor history or active malignant tumor need be treated
2. Researchers determine unsuited to participate in this trial
A Study To Evaluate Safety And Efficacy Of IV Sildenafil In The Treatment Of Neonates With Persistent Pulmonary Hypertension Of The Newborn

This study will evaluate whether IV sildenafil can reduce the time on inhaled nitric oxide treatment and reduce the failure rate of available treatments for persistent pulmonary hypertension of the newborn.


Eligibility Criteria:
Inclusion Criteria:

* Neonates with persistent pulmonary hypertension of the newborn
* Age \<=96 hours and \>=34 weeks gestational age
* Oxygenation Index \>15 and \<60
* Concurrent treatment with inhaled nitric oxide and \>=50% oxygen

Exclusion Criteria:

* Prior or immediate need for extracorporeal membrane oxygenation or cardiopulmonary resuscitation
* Expected duration of mechanical ventilation \<48 hours
* Profound hypoxemia
* Life-threatening or lethal congenital anomaly