cyrilzakka/clinical-trials huggingface dataset:
Utility of Anatometabolic Imaging for Radiation Treatment Planning for Lung Cancer

This is a research study for patients with inoperable lung cancer called non-small cell lung cancer (NSCLC). Currently, the information from a radiological test, computed tomography (CT) scan of the chest, is used to design the best arrangement of radiation beams which will kill tumor cells and still spare the normal parts of lungs and other normal organs in the chest. The purpose of this study is to explore whether adding information from another radiological test, called positron emission tomography (PET), will improve the accuracy of the radiation beam arrangement designed to treat lung cancer. A PET scan is a way to picture the biochemistry of tissues and organs: of how tissues in the body take up glucose, a normal nutrient of the body. The researchers will attempt to create radiation treatment plans from PET images alone and compare differences between hypothetical plans and standard-of-care CT-based radiation treatment plans. Because there is honest uncertainty about the contribution of PET to radiation treatment planning, it is possible that there will be no difference between a CT-based treatment plan and one resulting from PET information. It is also possible that the addition of PET may result in a radiation beam arrangement that may better control lung cancer. The addition of PET may also result in treating less normal tissues, which may lower the risk of radiation side effects. This study will provide the preliminary data necessary to design a larger clinical trial that may define the role of PET in radiation treatment planning.


Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed locally advanced NSCLC (squamous, large cell undifferentiated or adenocarcinoma).
* Disease limited to the thorax, adjacent mediastinum and neurovascular structures, and supraclavicular or scalene lymph node area, as defined by the AJCC Staging System. This includes patients with Stage IIIA and IIIB disease.
* Performance status of 0-2 by Southwest Oncology Group criteria.
* Medically inoperable patients (Stage I or II)
* Locoregional recurrent tumor following surgery will be eligible provided they meet other eligibility criteria.
A Study Comparing Lafullen15 and Lafullen for Temporary Nasolabial Fold Improvement

The objective of this clinical trial is to verify the safety and efficacy of Lafullen15 in the temporary improvement of nasolabial Folds


Eligibility Criteria:
Inclusion Criteria:

1. Individuals who desire an improvement in the appearance of the nasolabial fold on both sides of the face and who have a score of 3 or 4 on the Wrinkle Severity Rating Scale (WSRS)
2. Individuals who have consented to abstain from any other dermatological procedures or treatments, including treatments for wrinkle reduction in the facial area, during the duration of this study

Exclusion Criteria:

1. Administered an anticoagulant (with the exception of low dosage aspirin (100mg, up to 300mg/day)) within 2 weeks of the date of the screening
2. Administered Vitamin E or non-steroidal anti-inflammatory drugs or Collagen within 1 week of the date of the screening, or who require these during the period of the study
3. History of bleeding disorder in past or present
4. Received deep-peeling, skin regeneration, plastic surgery (including botulinum toxin injection), wrinkle improvement or acne scar treatment in the facial area within 24 weeks of the date of the screening
5. Administered an hyaluronic acid filler within 24 weeks of the date of the screening
Epidural Analgesia During Labour

Randomized single blind trial based on comparing the way the local anesthetic is dosificated during labour. The pain control is evaluated and compared with both dosage techniques (PCEA vs PIEB)using levobupivacaine and fentanyl. The primary objective is to see no differences in pain control(VAS, Visual Analog Scale). The secondary goals are the differences in motor block(Bromage Scale), satisfaction (Likert Scale), the outcome (eutocic, instrumental o cesarean section), second stage of labour time, newborn´s Apgar and pH and total dosis and secondary effects of local anesthetic.

There is a protocol where every healthy primiparous women have the chance to join the study after the explanation and the informed consent is signed. There are blind envelopes with the two kinds of treatment and the investigator only has to follow the protocol.

Eligibility Criteria:
Inclusion Criteria:

* 20- 40 years-old women
* Primiparous women
* Dilatation 3- 7 cm
* No risk illnesses for epidural block
* No risk pregnancy
* Signed informed consent

Exclusion Criteria:

* Illnesses which are a risk for pregnancy
* Multiparous women
* Contraindicated diseases for epidural block
* Women who can not understand the procedure
* Women who do not want to sign the informed consent
* Patients with drug´s allergy
A Comparative Study Between the Different Levels of TMJ Arthroscopy in the Management of TMJ Internal Derangement

The temporomandibular joint (TMJ) arthroscopy has emerging role nowadays in the treatment of TMJ internal derangement with its three levels of intervention. A comparative study between the 3 levels is essential to develop a standardized selection criteria and management algorithm.


Eligibility Criteria:
Inclusion Criteria:

* Patients with TMJ internal derangement Wilkes III

Exclusion Criteria:

1. Medically unfit patients.
2. Patients with TMDs secondary to malocclusion.
3. Psychological instability.
4. Patients operated before for other TMJ problems.
Efficacy Study of a New Antimicrobial Wound Dressing to Treat Wounds Caused by Curettage and Electrodesiccation

The purpose of this pilot clinical study is to compare healing rates, pain levels, and incidence of wound complications including infection with the use of a moist PROCELLERA™ Antimicrobial Wound Dressing when compared to a standard dressing, Mepilex® Border Lite, following curettage and electrodesiccation of skin lesions.


Eligibility Criteria:
Inclusion Criteria:

If female, must either be not of childbearing potential or if they are of childbearing potential must have a negative urine pregnancy test.

* Wound size greater than 1x1 cm
* Wounds must be ≥5 cm away from all other wounds
* Wound size must not be diminished in size greater than 10% between enrollment in study and the prescreening
* Participant agrees to participate in follow-up evaluation
* Participant must be able to read and understand informed consent, and sign the informed consent

Exclusion Criteria:

* Concurrent participation in another clinical trial that involves an investigational drug or device that would interfere with this study
* Participant is to receive another topical antimicrobial agent other than the study dressing
* Participant with sensitivity or adverse reactions to silver or zinc
* Pregnancy or nursing an infant or child
* Immunosuppression
* Active or systemic infection
* Peripheral vascular occlusive disease
* Collagen vascular disease
* Connective tissue disease
* Diabetes
* Venous stasis ulcers
* Participant undergoing active cancer chemotherapy
* Chronic steroid use
* Decision impairment
Clinical Study to Evaluate the Efficacy of Prasterone Treatment for Atrophy Vulvovaginal in Postmenopausal Women With Vulvar / Vestibular Pain

A prospective, open, randomized and controlled clinical intervention study in women over 45 years of age with a diagnosis of vulvovaginal atrophy (dryness and / or dyspareunia, etc.) and vulvar and / or vestibular pain. The efficacy of Prasterone treatment is evaluated in those patients willing to undergo the treatment compared to the control group.

A sample of 50 women over 45 years of age with at least one year of amenorrhea and who require treatment for vulvovaginal atrophy of moderate and / or severe intensity and who present vulvar and vaginal pain within these symptoms will be chosen.

At the beginning of the study, after passing the selection criteria and signing the informed consent, the patients will be randomly assigned to one of the two arms of the study, (active group) or (control group), said assignment will be made randomly. Through a computer program where one or the other arm of treatment will be assigned to the patient at random to guarantee the homogeneity of both study groups and thus avoid selection biases.

Eligibility Criteria:
Inclusion Criteria:

* Women over 45 years of age with at least one year of amenorrhea and at least one symptom of vulvovaginal atrophy of moderate and / or severe intensity.
* Women with moderate to severe vulvar / vestibular pain
* Women without symptoms or signs of acute vaginal infection.
* Women without symptoms of urinary infection and a negative urine strip result.
* Woman willing to carry out the study procedures and comply with the visits.
* Woman who signs the Informed Consent.

Exclusion Criteria:

* Hormone treatment in the last three months for vulvovaginal atrophy
* Treatment with vaginal moisturizers in the last week for vulvovaginal atrophy
* Laser treatment in the last 6 months.
* Acute and recurrent urinary tract infections in the last 3 months.
* Acute genital infections (herpes, candida, etc)
* Personal history of cancer at any level
* Present alterations in the area to be treated, such as lacerations, abrasions or ulcers (resolution time at the medical discretion)
* Decompensated non-communicable chronic diseases (Diabetes Mellitus, Heart Disease ...)
* Participation in a clinical study 3 months before inclusion or during this study.
* Hypersensitivity to the active principle or any of the excipients
* Undiagnosed vaginal bleeding.
* Untreated endometrial hyperplasia
* Acute liver disease or a history of liver disease while liver function tests remain impaired.
* Current diagnosis or history of venous thromboembolism (deep vein thrombosis, pulmonary embolism)
* Known thrombophilic disorders (protein C, protein S, or antithrombin deficiency)
* Current or recent diagnosis of arterial thromboembolic disease (angina, myocardial infarction)
* Porphyria
Duloxetine in the Treatment of Melancholic Depression

The purpose of this study is to determine the optimal treatment strategy for MDD patients with melancholic features who do not respond to a standard daily dose. This study will allow investigators to mimic standard clinical practice. During the first 2 weeks of treatment, clinical evaluation of individual patient tolerability and efficacy will enable the dose of duloxetine to be adjusted. Patients allocated to the Flex group may have their daily dose of duloxetine adjusted in the attempt to elicit a clinical response.


Eligibility Criteria:
Inclusion Criteria:

* Have a diagnosis of major depression with melancholic features, as defined by Diagnostic and Statistical Manual of Mental Disorders Fourth Edition \[DSM-IV\] criteria.
* Experienced their first episode of major depression prior to age 50.
* Have a HAMD17 total score of less than or equal to 20 at Visits 1 and 2.
* Test negative for a urine pregnancy test at Visit 1 (females).
* Agree to use medically acceptable and reliable means of birth control during the study, as determined by the investigator (females of child-bearing potential, not surgically sterilized and between menarche, and one year post-menopausal).

Exclusion Criteria:

* Have any current and primary Axis I mood disorder other than MDD, including, but not limited to, dysthymia, seasonal affective disorder or psychotic depression.
* Have a current episode of major depression that has failed to respond to two or more courses of antidepressant therapy or, in the judgment of the investigator, meets criteria for treatment-resistant depression
* Are at serious suicidal risk as determined by the investigator.
* Have a serious medical illness or clinically significant laboratory abnormalities that, in the judgment of the investigator, are likely to require medication/ intervention/ hospitalization during the course of the study.
* Had treatment with a monoamine oxidase inhibitor (MAOI) within 14 days prior to Visit 2 or potential need to use a MAOI during the study or within 14 days of discontinuation of study drug.
Assessing a Height Artificial Intelligence Algorithm to Estimate Height of Children

An exploratory study to explore the possibility of using computer vision algorithms to estimate a child's height using images taken by a healthcare professional or parents.

This is an exploratory, observation, data-collection study that aims to evaluate the performance of a Height Artificial Intelligence (HAI) algorithm in a real world setting. Images will be collected by parents or healthcare professionals, together with physical height measurements. This data will be used to evaluate the accuracy of the algorithm and to explore potential improvements. Data on the acceptance and experience of using the algorithm will be collected for improvements.

Eligibility Criteria:
Inclusion Criteria:

* Children aged above 24 months old and below 6 years old.
* Parent(s) should have access to the internet and a smartphone or table to complete study questionnaires, take images and upload images.
* Parent(s) should be able to comprehend the content of the study and complete the study questionnaires in English.
* Written consent from parents and/or legally acceptable representative

Exclusion Criteria:

* Children who are unable to stand upright against a wall
* Children who are unable to cooperate with standing height measurement
Management of Spontaneous Ruptured Hepatocellular Carcinoma

To investigate the best treatment for hepatocellular carcinoma rupture

To investigate the best treatment for hepatocellular carcinoma rupture, transcatheter arterial embolization or partial hepatectomy. Furthermore, to discuss the choice of emergency or staged hepatectomy.

Eligibility Criteria:
Inclusion Criteria:

* Being diagnosed as hepatocellular carcinoma with tumor rupture; with complete data and without loss of follow-up

Exclusion Criteria:

* Without complete data; with loss of follow-up; not hepatocellular carcinoma based on pathological diagnosis
Thrombus Imaging and Treatment Analytics in Neurology

In the present study, the investigators use high-resolution MR vessel wall imaging, and select patients with cerebral and cervical artery occlusion to investigate the relationship between the imaging appearance of thrombus and the various outcome of recanalization treatment.

Cerebral ischemic stroke resulting from thrombosis causes high disability and mortality. There are few biomarkers to evaluate arterial thrombophilia until now. Previous studies have demonstrated that atherosclerotic plaque rupture and erosion are major etiologies initiating thrombosis. Based on previous works targeting the role of plaque and blood flow in cerebrovascular disease, in the present study, the investigators use high-resolution MR vessel wall imaging, and select patients with cerebral and cervical artery occlusion to explore the relationship between the imaging appearance of thrombus and the various outcome of recanalization treatment. The study's objective was to solve the challenges in the mechanism of thrombus features and the outcome of recanalization therapy, thus helping improve the primary and secondary prevention of cerebrovascular disease.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* Extracranial and/or intracranial artery occlusion confirmed by angiography
* Available for magnetic resonance high-resolution vessel wall imaging
* Written informed consent obtained

Exclusion Criteria:

* Extracranial and/or intracranial artery mild to moderate stenosis
* Pregnant women
* Restenosis or occlusion after artery stenting placement
A Study to Evaluate the Long-Term Efficacy and Safety of BMN 110 in Patients With Mucopolysaccharidosis IVA (Morquio A Syndrome)

This multicenter, open-label extension study is designed to assess long-term efficacy and safety of 2.0 milligrams (mg)/kilogram(kg)/week of BMN 110 in patients diagnosed with Mucopolysaccharidosis IVA (MPS IVA). Patients with MPS IVA, who enrolled in a prior BioMarin sponsored clinical study of BMN 110 (NCT00884949; Study Identification Number MOR-002), were eligible to enroll in this study (except patients who enrolled in NCT01275066; Study Identification Number MOR-004).


Eligibility Criteria:
Inclusion Criteria:

* Willing and able to provide written, signed informed consent, or in the case of patients under the age of 18 (or 16 years, depending on the region), provide written assent (if required) and written informed consent by a legally authorized representative after the nature of the study has been explained, and prior to any research-related procedures.
* Sexually active patients must be willing to use an acceptable method of contraception while participating in the study.
* Females of childbearing potential must have a negative pregnancy test at Baseline and be willing to have additional pregnancy tests during the study.
* Must have enrolled in a prior BioMarin sponsored clinical study of BMN 110.

Exclusion Criteria:

* Pregnant or breastfeeding at Baseline or planning to become pregnant (self or partner) at any time during the study.
* Use of any investigational product (other than BMN 110 in a prior clinical study) or investigational medical device within 30 days prior to Baseline, or requirement for any investigational agent prior to completion of all scheduled study assessments.
* Concurrent disease or condition, including but not limited to symptomatic cervical spine instability, clinically significant spinal cord compression, or severe cardiac disease that would interfere with study participation or safety as determined by the Investigator.
* Any condition that, in the view of the Investigator, places the patient at high risk of poor treatment compliance or of not completing the study.
* Were enrolled in MOR-004 (patients from MOR-004 may be eligible to participate in a separate, appropriately designed, extension study).
The Impact of Lumboscopy Versus Laparoscopy on Ventilatory Mechanics

There are several techniques for performing minimally invasive urological surgeries. Among them, laparoscopic surgery, robotic surgery, and lumboscopy are noteworthy (1). The medical literature extensively documents the impact of pneumoperitoneum a procedure involving the insufflation of the peritoneal cavity with carbon dioxide (CO2), which is essential for laparoscopic and robotic surgeries on ventilatory mechanics.

As an alternative, CO2 insufflation into the retroperitoneum, as utilized in lumboscopic surgery, has been proposed. This approach is believed to exert a lesser impact on respiratory function and pulmonary mechanics. However, it is important to note that no conclusive evidence has yet been found to support this claim.

Assessing the impact of lumboscopic surgery could help establish it as a viable alternative for patients with pulmonary conditions, where mechanical ventilation poses significant challenges. To explore this possibility, a physiological study was designed to compare the effects of laparoscopic and lumboscopic surgery on ventilatory mechanics.


Eligibility Criteria:
Inclusion Criteria:

* Age \>18 years old
* ASA PS II-III
* Elective surgery
* Surgery: Partial or total nephrectomy

Exclusion Criteria:

* Severe pulmonary pathology
* Severe cardiovascular pathology
* Open surgery
A Trial to Reduce Pneumonia in Nursing Home Residents

The purpose of this study is to test the effectiveness of an enhanced oral hygiene protocol in preventing pneumonia among nursing home residents.


Eligibility Criteria:
Inclusion Criteria:

* long term care resident of nursing home
* residents age \>65
* residents of nursing home for at least one month
* residents having at least one of two modifiable risk factors for pneumonia (i.e., impaired oral hygiene, swallowing difficulty)

Exclusion Criteria:

* residents housed in nursing home for short term rehabilitation
* residents who receive nourishment by tube feeding
* residents who have a life expectancy \< 3 months
* residents who have been diagnosed with pneumonia within the previous 6 weeks
* residents who are currently using oral chlorhexidine
* residents who have previously been enrolled in the study
* residents, or their designated proxies, who are unwilling to give informed consent
* residents who have tracheostomy
* residents who are non-english speaking
* residents who the administrator leadership of the home felt were not appropriate for the study
Efficacy Study of Pacemakers to Treat Slow Heart Rate in Patients With Heart Failure

Determine the impact of restoring normal heart rate response during exercise and daily activity in patients with heart failure and a preserved ejection fraction (HFpEF) and chronotropic incompetence (CI).


Eligibility Criteria:
Inclusion Criteria

1. Age \>18 years and able to provide informed consent to enroll in the trial, or consent through a legal guardian or power of attorney.
2. Previous clinical diagnosis of HF with current NYHA Class II-III symptoms
3. At least one of the following: Hospitalization for decompensated HF, Acute treatment for HF with intravenous loop diuretic or hemofiltration, Chronic treatment with a loop diuretic for control of HF symptoms + left atrial enlargement on echocardiography or E/e' ratio (≥14 average, ≥15 septal ) on echocardiography, Resting PCWP \>15 mm Hg or LV end-diastolic pressure \>18 mmHg at catheterization for dyspnea and/or exercise PCWP/LV end-diastolic pressure \>25 mmHg, or Elevated NT-proBNP level (≥300 pg/ml )
4. Left ventricular EF ≥40% within 12 months with clinical stability
5. Stable cardiac medical therapy for ≥30 days
6. Sinus rhythm
7. Chronotropic incompetence on recent (within 6 months) clinical or screening exercise test, defined as heart rate reserve (HRR) \<0.80 or \<0.62 if on beta blockers
8. Meet both screening criteria on clinically-performed cardiopulmonary exercise testing within 12 months.

Exclusion Criteria

1. Inability to exercise, or non-cardiac condition that precludes exercise testing
2. Any contraindication to a pacemaker system
3. Non-cardiac condition limiting life expectancy to less than one year
4. Significant left sided structural valve disease (\>mild stenosis, \>moderate regurgitation)
5. Hypertrophic cardiomyopathy
6. Infiltrative or inflammatory myocardial disease (amyloid, sarcoid)
7. Pericardial disease
8. Non-group 2 pulmonary arterial hypertension
9. Chronic stable exertional angina
10. Acute coronary syndrome or revascularization within 60 days
11. Other clinically important causes of dyspnea
12. Atrial fibrillation
13. PR interval \>210 msec
14. Resting heart rate (HR) \> 100 bpm
15. A history of reduced ejection fraction (EF\<40%)
16. Advanced chronic kidney disease (GFR \< 20 ml/min/1.73m2 by modified MDRD equation)
17. Women of child bearing potential without negative pregnancy test and effective contraception
18. Severe anemia (Hemoglobin \<10 g/dL)
19. Severe hepatic disease
20. Complex congenital heart disease
21. Listed for cardiac transplantation
22. Other class I indications for pacing