cyrilzakka/clinical-trials huggingface dataset:
Constrained Balloon Combined With Drug-coated Balloon Angioplasty for Femoropopliteal Lesion

This study will assess the safety and efficacy of Chocolate balloons as a combination with drug-coated balloons in the treatment of popliteal artery lesions in lower limb atherosclerotic occlusive disease and will compare them with conventional balloons.


Eligibility Criteria:
Inclusion Criteria:

* Rutherford classification of 2-6 in patients with femoropopliteal atherosclerotic occlusive disease;
* primary cases with no previous surgical treatment of the target lesion;
* presence of at least one vessel with patency in the distal outflow tract;
* survival \>1 year.

Exclusion Criteria:

* planned stenting;
* presence of flow-limiting dissection prior to application of Chocolate balloon and conventional balloon dilation of the target lesion;
* combination of severe organ dysfunction of the heart, lungs and brain that cannot tolerate the procedure;
* allergy to contrast agents, anaesthetic drugs, anticoagulants and anti-platelet drugs;
* ineffective recanalization attempts;
* lesions within or adjacent to the aneurysm, or the presence of a popliteal aneurysm.
Buprenorphine Pharmacology Related to Addiction Treatment - 18

The purpose of this study is to examine the interactions between buprenorphine and naltrexone, and to assess how they may directly impact the clinical issues involving: transferring patients from buprenorphine to naltrexone, developing a non-abusable form of buprenorphine, and enhancing patient acceptability of naltrexone.


Eligibility Criteria:
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Relationship Between CT- Value With Prognosis in COVID-19 Patients

evaluate the relationship between cycle threshold number with final prognosis in COVID-19 patients

evaluate the relationship between cycle threshold number with final prognosis in COVID-19 patients

Eligibility Criteria:
Inclusion Criteria:

* COVID-19 PCR positive

Exclusion Criteria:

-
Portuguese Registry on Interventional Cardiology

The purpose of this Registry is creating a database management that allows continuous monitoring characteristics, evolution, prognostic indicators and management of patients undergoing coronary angioplasty in Portuguese Hospitals, and identify the appropriateness of clinical and interventional practice recommendations for diagnosis and treatment of coronary disease and monitoring its evolution.

Cardiovascular disease remains the main cause of death in Portugal and approximately one quarter of these are directly to ischemic heart disease. In order to better characterize percutaneous coronary intervention in Portugal, the Portuguese Society of Cardiology has promoted the Portuguese registry on percutaneous coronary intervention.

This will include all adult patients (≥ 18 years), eligible for percutaneous coronary intervention (PCI) in accordance with PCI state-of-art recommendations (including unstable and stable coronary disease). The Cardiology department where the patient has been hospitalized is responsible for the patient inclusion in the study.

Excluded patients are those in whom the preferred treatment is Coronary Artery Bypass Graft (CABG), age under 18 years or life expectancy of less than 12 months.

Eligibility Criteria:
Inclusion Criteria:

1. Patients with:

   * stable angina or,
   * stabilized angina pectoris or,
   * atypical chest pain or,
   * no chest pain but with documented silent ischemia
2. At least one stenosis is present of at least 50% in one major native epicardial coronary artery and supplying viable myocardium
3. Eligible for PCI
4. Informed consent

Exclusion Criteria:

1. Patients in whom the preferred treatment is CABG;
2. Contra-indication to dual antiplatelet therapy
3. Coronary artery disease precluding PCI
4. A life expectancy of less than 1 year
5. Age under 21
Heat Therapy Versus Exercise Training in Hypertension

This is a clinical trial to determine whether 30 sessions of heat therapy in the form of hot water immersion is better than 30 sessions of traditional aerobic exercise training on blood pressure reduction in people with elevated or Stage 1 hypertension.

Hypertension accounts for more cardiovascular disease related deaths than any other modifiable risk factor. While exercise training can be effective at reducing blood pressure in some individuals, many people do not respond to exercise training, and many more are unwilling to undergo regular exercise training. Alternative options need to be explored. This is a clinical trial to determine whether 30 sessions of heat therapy in the form of hot water immersion is better than 30 sessions of traditional aerobic exercise training on blood pressure reduction in people with elevated blood pressure (hypertension). The investigators will evaluate known biomarkers of cardiovascular health. It is hypothesized that heat therapy will be superior to exercise training on blood pressure reduction.

Eligibility Criteria:
Inclusion Criteria:

* Systolic Blood Pressure 120 mmHg or greater and less than 180 mmHg or Diastolic Blood Pressure of 80mmHg or greater and less than 120mmHg

Exclusion Criteria:

* Secondary hypertension; diagnosed cardiovascular disease other than hypertension; taking anti-hypertensive drugs; BMI of 35 or greater; fasting glucose greater than 125 mg/dl; women who are pregnant, nursing, or desiring to become pregnant.
Growing Little PEAPODS Study

The goal of this clinical trial is to learn more about how the food and nutrition babies receive while in the Neonatal Intensive Care Unit (NICU) influences their ability to gain weight and fat-free mass, and their future growth and development.

Participants will:

* have body growth measurements collected using the PEAPOD device
* have nutritional information collected, and
* be followed for neurodevelopmental outcomes

Participants can expect to be in the study for 36 months.


Eligibility Criteria:
Neonate Inclusion Criteria:

* Born inpatient at Meriter Hospital, Inc. at or above 22 gestational weeks. Upper limit is 32 weeks 6 days GA (possible gestational age range from 22w0d-32w6d)

Neonate Exclusion Criteria:

* Known genetic condition that impacts neurodevelopmental outcomes or brain structure development
* Multiple major congenital anomalies
* Per the investigator's opinion, the subject will likely require transfer to American Family Children's Hospital (AFCH) before 36 weeks PMA

  * Any neonate who enrolls in the study and then unexpectedly requires transfer to AFCH before 36 weeks PMA will be excluded from the study if they are unable to obtain at least one body composition measurement before transfer. Body composition data points can only be collected at Meriter Hospital due to the location of PEAPOD

Birthing Parent Inclusion Criteria:

* Birthing parent must speak English or Spanish due to consent documents
* Able to understand and willing to sign a written informed consent document
* Primary caregiver of a neonate who is eligible to participate in the study
* Agrees to enroll neonate into the study
* Willing to comply with all study procedures and be available for the duration of the study
* Age 15 or older

Birthing Parent Exclusion Criteria:

* Subject is unable to provide informed consent, including subjects in foster care and subjects within state custody
* Does not plan to maintain custody of the child after birth, such as in instances of adoption or surrogacy
Italian Registry on Unprotected Left Main

The RITMO (Registro Italiano sul trattamento del Tronco coMune non protettO) observational study will appraise the prevalence, management strategy, and prognosis of unprotected left main coronary artery disease in Italy.

The RITMO (Registro Italiano sul trattamento del Tronco coMune non protettO) observational study will be a prospective, multicenter, observational study aiming to appraise the prevalence, management strategy, and prognosis (up to 5 years) of unprotected left main coronary artery disease in Italy. A total of 45 Italian secondary and tertiary care centers will participate, and enroll patients during a period of 12 to 18 months. Patients will be included provided that they complete a written informed consent form and significant unprotected left main coronary artery disease is established at diagnostic coronary angiography. The primary end-point will be the 12-month rate of major adverse cerebro-cardiovascular events (ie death, myocardial infarction, stroke, or coronary revascularization).

Eligibility Criteria:
Inclusion Criteria:

* angiographic evidence of significant unprotected left main disease
* lack of patent bypass grafts for the left coronary system
* willingness to complete written informed consent form
* willingness to comply with subsequent follow-up contacts

Exclusion Criteria:

* lack of written informed consent form
* inability to comply with subsequent follow-up contacts
Evaluation of Software Generated Customized Foot Orthoses

The purpose of this study is to determine whether custom-made foot orthoses generate a significant decrease in the perception of pain among individuals with foot pain and/or ankle pain.

The investigators aim to enroll up to 60 participants over the course of 1-3 months. Each participant will be evaluated at baseline, when the customized foot orthoses will be made, and the corresponding tests will be conducted. Subsequently, consecutive surveys will be carried out at 0, 7, 30, 120, and 360 days from the first day of foot orthoses use to measure the change in pain and comfort with use of the foot orthoses. An interim analysis will be conducted after all subjects have completed the 30-day time point. This interim analysis will allow the sponsor to determine whether subjects are using the foot orthoses that the subjects have been provided. Complete primary analysis is estimated to be completed within 3 months after the termination of the study.

Eligibility Criteria:
Inclusion Criteria:

1. Foot/ankle pain or pathology OR diagnosed pes planus, pes cavus, pronator foot, supinator foot, metatarsalgia, Morton's neuroma, sesamoiditis, hallux valgus, intermetatarsal bursitis
2. Between 18 and 65 years of age
3. BMI is greater than 18.5 or less than 30

Exclusion Criteria:

1. Individuals who have had surgery in the lower limbs during this past year.
2. Individuals who already have custom-made orthopedic orthoses.
3. Patients with active diabetic ulcers or chronic foot pressure ulcers.
Knowing and Treating Kosaki/Penttinen Syndromes

Kosaki overgrowth syndrome (KOGS) and Penttinen syndrome (PS) are extremely rare multisystem disorders caused by heterozygous activating variants of the PDGFRB gene. KOGS results in characteristic craniofacial, orthopedic, skin and neurological disorders. PS is a progeroid disease responsible for a prematurely aged appearance. Patients suffer significant morbidity and mortality due to various complications. Tyrosine Kinase Inhibitors (TKIs) targeting PGDFRB appear to be a potential treatment option, as evidenced by a few case reports showing clinical improvement in some patients, with modest and self-resolving side effects. The natural history of these two syndromes remains poorly understood as only case-reports have been published.

Therefore, an international consortium was created in December 2019 by Pr FAIVRE (CHU Dijon Bourgogne \& ERN ITHACA) to follow treated and untreated patients in a real-life, multicentre, observational study, in order to expand our knowledge of these ultra-rare diseases. In the longer term, we believe that TKIs could bring clinical benefit to KOGS/PS patients.


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of Kosaki or Penttinen syndrome
* Molecular diagnosis of an activating variant in PDGFRB gene
* Patient who has been informed and provide a written informed consent

Exclusion Criteria:

* Absence of clinical diagnosis of Kosaki or Penttinen syndrome
* Absence of molecular diagnosis of an activating variant in the PDGFRB gene.
* Patient who has not been informed and/or did not provide a written informed consent.
Efficacy of Self-hypnosis for Weight Loss in Type 2 Diabetics

Randomized study evaluating self-hypnosis versus certified diabetes educator training for weight loss in type 2 diabetics.

Study Subjects: Approximately 74 type II diabetics will be randomized. Key inclusion criteria: overweight (BMI≥25), motivated to lose weight, and are at least 18 years of age.

Key exclusion criteria: pregnant women or women of childbearing age, currently taking medications for weight loss, enrolled in another clinical trial, or planning on having bariatric surgery. Any patient who is taking medication prescribed by a physician for depression, anxiety, or any other psychiatric disorder will be excluded. Patients on glucocorticoids in excess of Prednisone 7.5 mg or equivalent will also be excluded.

Study Design: All patients who pass screening will be administered the IPQ Test®\[6\]. This test stratifies patients on how they use their imagination, an important factor necessary to reach their goals. This is predictive of their potential to "persist" toward agreed upon goals. Patients will be divided into groups as follows: (Raw score 49-96 = high responders; Raw score 0-48 = Low responders).

Ultimately, subjects will be divided into four groups: The assignment of "high" versus "low" responders will be based on the results of the IPQ® test. Subjects will then be randomly assigned to intervention versus control in a 1:1 fashion. Optimally, there should be equal numbers in each group; however, the group sizes may be unequal depending on the relative proportions of high versus low responders. The four groups will be as follows:

Group I (high responders) will receive self-hypnosis using the GIFT™ (Goal Image Focusing Technique)\[7\] as the main means of autosuggestion and self/group motivation to lose weight.

Group II (low responders) will receive self-hypnosis (without the GIFT™ system) and self/group motivation to lose weight.

Group III (high responders) will receive standard nutrition, diet, and exercise counseling by a CDE (Certified Diabetes Educator) to serve as a control group for Group I.

Group IV (low responders) will receive standard nutrition, diet, and exercise counseling by a CDE (Certified Diabetes Educator) to serve as a control for group II.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Type 2 Diabetes
* BMI greater than 25

Exclusion Criteria:

* pregnant women of of childbearing age
* currently taking weight loss medications
* enrolled in another clinical trial
* currently taking medications for depression or anxiety
* currently taking Prednisone \>7.5 mg day
Diabetes and Sports: Evaluation of a Diabetes Education Module

This study is a multi-center, randomized prospective trial with a 6-month follow up. A newly developed treatment and education module will be tested compared to a waiting-list control group. The module covers the topic "diabetes and sports". Primary outcome variable is diabetes-specific empowerment regarding diabetes and sports. Secondary outcome variables are: diabetes-related distress, health-related quality of life, depressive symptoms, self-care behavior, and glycemic control.

The module consists of one lesson (duration: 90 minutes). The module is derived from the empowerment approach and is based on the previously evaluated education and treatment program for type 1 diabetes: PRIMAS (NCT01220557). The module is designed as a group session held by a trained diabetes educator. Patients are randomized either to the immediate participation in the module or to the control group. Control group is a waiting-list control group. Patients in this waiting-list control group get the education after the completion of the 6-month follow-up.

Eligibility Criteria:
Inclusion Criteria:

* Intensive insulin treatment
* specific interest in "Diabetes and Sports"
* wish to participate in group education
* informed consent
* fluent in reading and speaking German language

Exclusion Criteria:

* diabetes duration \< 4 week
* severe organic disease (e.g. terminal renal disease, cancer with poor prognosis)
* current treatment of a mental disease
* cognitive impairment
* dementia
* pregnancy
A Proof of Principle Study of Aminolevulinic Acid (ALA) - Induced Fluorescence Detection in Resectable Non-Small Cell Lung Cancer

The purpose of this trial is to measure ALA-induced fluorescence in both normal and malignant tissue.


Eligibility Criteria:
Inclusion Criteria:

* Inclusion Criteria Patients (12 total patients with lung cancer) meeting eligibility criteria will be enrolled.
* Preoperative diagnosis of either presumed or documented non-small cell lung cancer.
* Tumor judged to be suitable for surgical resection based on preoperative evaluation of radiographic studies, pulmonary function tests, performance status and clinical judgment of surgeons at DHMC (Erkmen, Nugent)
* Age ≥ 18 years old.
* Population representative of our usual referral pattern including minority populations, women and those who are financially disadvantaged.
* Subjects capable of giving informed consent

Exclusion Criteria:

* Pregnant Women
* Women who are breast feeding
* History of cutaneous photosensitivity
* Porphyria, hypersensitivity to porphyrins, photodermatosis
* Exfoliative dermatitis
* History of liver disease within the last 12 months
* Inability to comply with photosensitivity precautions associated with the study
* Inability to give informed consent
* AST, ALT, ALP or bilirubin levels greater than 2.5 times the normal limit at any time during the past 2 months
* Plasma creatinine in excess of 180 umol/L
* Women who are breast feeding
* History of cutaneous photosensitivity
* Porphyria, hypersensitivity to porphyrins, photodermatosis
* Exfoliative dermatitis
* History of liver disease within the last 12 months
* Inability to comply with photosensitivity precautions associated with the study
Pain and Anxiety Reducing During Dental Treatment in Children Using Video Game on Tablet Device With Joystick.

The aim of this study is to evaluate the effectiveness of two different distraction techniques (Audio Video Distraction /Video Game Distraction) in the management of anxious pediatric patients during dental treatment.

Group A: pulpotomy in temporary inferior molar will be treated with using video game on tablet device with wireless joystick and wireless headphone

Group B: pulpotomy in temporary inferior molar will be treated with using AV tablet and wireless headphone.

Group C (Control group): pulpotomy in temporary inferior molar will be treated with basic behavior guidance techniques and without using any type of distraction aids.

All of the children who experienced a pulpotomy in temporary inferior molar with/without distraction will be assessed by using a combination of measures: Simplified Wong-Baker faces(self-report), and "HOUPT" Behavior Rating Scale for Movement - Crying - Overall Behavior (nonself-report).

This study will evaluate the effectiveness of two types of distraction aids that contain video game on tablet device with wireless (joystick and headphone) along with audio video distraction using tablet device and wireless headphone.

Pain and anxiety will be evaluated during pulpotomy in temporary inferior molar using two behavioral scales, Simplified Wong-Baker faces (self-report), and "HOUPT" Behavior Rating Scale for Movement - Crying - Overall Behavior (nonself-report).

The Behavior Rating Scale "HOUPT" will be measured four times: directly when the patient seated comfortably on the dental chair, after anesthesia, after pulpotomy, and when the treatment completed.

All child patients will ask to choose a face that describe their status from one of the Simplified Wong Baker faces scale in the same four times.

Eligibility Criteria:
Inclusion Criteria:

1. age between 6 and 10 years.
2. no previous dental experience.
3. definitely positive or positive ratings of Frank scale.
4. Need of pulpotomy in temporary inferior molar.

Exclusion Criteria:

1. previous dental experience
2. systematic or mental disorders.
3. definitely negative or negative ratings of Frankel scale
4. don't need of pulpotomy in temporary inferior molar
Adjustable Fortification of Human Milk Fed to Chinese Preterm Infants

This clinical trial will compare how the individualized and fortified human milk feeding will help a premature infant grow.

A total of 60 premature infants who will be randomized to receive either a standard fortification regimen (n=30) or an adjustable fortification regimen (n=30). The adjustable fortification regimen encompasses increasing / decreasing the amount of fortifier and adding supplemental protein guided by periodic determinations of the protein concentration in human milk (PCHM), body weight and blood urea nitrogen (BUN). Growth rate, tolerance of enteral feeding, days to achieve 100kcal/kg/d through enteral feeding, length of parenteral nutrition and NICU stays will be measured and compared between groups.

Eligibility Criteria:
Inclusion Criteria:

* Less than 34 weeks gestational age at birth
* Birth weight within 800-1800 grams
* Exclusively or mostly breastfed (greater than 80% if the feeding volume)
* Tolerated enteral feedings of 60 ml/kg/d
* Remain in the Neonatal Intensive Care Unit at least 14 days prior to hospital discharge,remain in the Neonatal Intensive Care Unit at least 10 days after enrollment
* Signed Informed Consent

Exclusion Criteria:

* Small for gestational age
* Infants currently receiving ventilation therapy
* Major congenital malformations
* Suspected or documented systemic or congenital infections
* Evidence of cardiac, respiratory, endocrinologic, hematologic, gastrointestinal, or other systemic diseases that may impact growth
* Severe intraventricular hemorrhage (greater than grade II) or periventricular leukomalacia
* Suspected or documented maternal substance abuse
* Infants currently receiving glucocorticoids or infants who have received glucocorticoids within the past 28 days
PEG (Polyethylene Glycol)Versus Lactulose For Treatment Of Overt Hepatic Encephalopathy

The current standard of care for patients with HE includes non-absorbable disaccharides(lactulose);The chemical name for lactulose is 4-O-β-D-galactopyranosyl-D-fructofuranose.The exact mode of action by lactulose is thought to be the conversion to lactic acid and acetic acid by colonic bacteria resulting in acidification of the gut lumen. This favors conversion of ammonia (NH3) to ammonium (NH4+), which is relatively membrane impermeable; therefore, less ammonia is absorbed by the colon. Gut acidification inhibits ammoniagenic coliform bacteria, leading to increased levels of nonammoniagenic lactobacilli. Nonabsorbable disaccharides also work as a cathartic, clearing the gut of ammonia before it can be absorbed.

Polyethylene glycol electrolyte solution (PEG) is a laxative solution that increases the amount of water in the intestinal tract to stimulate bowel movements. It is used safely to clean the bowel before colonoscopy.

Eligibility Criteria:
Inclusion Criteria:

* Adult Patients with Overt Hepatic Encephalopathy.

Exclusion Criteria:

1. Patients with active GIT bleeding.
2. Patients with history of bowel obstruction, perforation.
3. Patients with history of allergy to PEG.
4. Treatment with rifaximin or neomycin in the previous 7 days.
5. Patients with major psychiatric illness.
6. Patients receiving benzodiazepines and narcotics.
7. Patients with compromised renal.
8. Patients receiving medications highly bound to plasma proteins eg. Warfarin.
9. Pregnant or lactating women.
10. Fulminant hepatic failure.