cyrilzakka/clinical-trials huggingface dataset:
Calcaneal Neck Lengthening Osteotomy in Children With Artificial Bone Graft

In a group of children with severe and painful flatfeet lengthening procedures of calcaneus can be indicated. In this study the investigators use an artificial bone graft technique to avoid removing bone graft from the iliac crest.

The aim is to study the clinical and radiological effects of calcaneal lengthening with either autogen bonegraft or a HA-βTCP graft material in a group of children with planovalgus. The hypothesis is that it is possible to achieve a stabile osteotomy with HA-βTCP graft material equal to the use of autogen bonegraft thus avoiding the need to obtaining iliac crest graft material at growing children.

Eligibility Criteria:
Inclusion Criteria:

* pain
* gait disturbance

Exclusion Criteria:

* post traumatic conditions
Electronic Hookah and Endothelial Cell Function

Electronic nicotine delivery systems (ENDS) are a rapidly growing global epidemic among adolescents and young adults. Unlike other ENDS such as e-cigarettes, e-hookahs are used through traditional water-pipes, allowing the vapor-containing nicotine, propylene glycol, glycerin, and flavorings-to pass through a water-filled basin, potentially altering the vapor, before it is inhaled through the user's mouth. Contributing to e-hookahs popularity is the belief that the flavored smoke is detoxified as it passes through the water-filled basin, rendering e-hookah a safer tobacco alternative. However, an e-hookahs deliver flavored nicotine by creating a vapor of fine particles and volatile organic compounds that could induce vascular toxicity. While e-hookah vaping acutely reduces endothelial function, the specific role of nicotine and the mechanisms by which it may impairs endothelial function remain understudied. The objective of this project is to investigate the specific role of nicotine in mediating the acute effects of e-hookah vaping on endothelial dysfunction.


Eligibility Criteria:
Inclusion Criteria:

* 21-39 years old hookah smokers: smoked hookah \>12x in last 12 months
* 21-39 years old e-cigarette users: vaped \>12x in last 12 months
* no history of illicit drugs
* no evidence of cardiopulmonary disease by history/ physical
* no diabetes: fasting blood glucose \<100 mg/dl
* BP\<140/90mmHg
* resting HR\<100 bpm
* BMI\<30kg•m2
* no prescription medication

Exclusion Criteria:

* exhaled CO\>10 ppm (smoking non-abstinence)
* positive pregnancy test
* psychiatric illness
Patient Provider Communication and Interaction in a Virtual Clinical Setting

Summary:

A few studies have explored factors which influence patient-provider communication in a controlled setting. However, more information is needed about how different factors affect communication so that it can be improved.

Third- and fourth-year medical students may be eligible for this study. Participants are recruited from the Washington, D.C. area.

At the research center, participants will use a virtual reality headset to view a virtual clinic environment and interact with a virtual patient.

After interacting with the virtual patient, participants will complete a questionnaire about their experience within the virtual clinic and other research-related information.

The total time for the study visit is 60 minutes.

Eligibility:

Third- and fourth-year medical students at least 18 years of age. You may not take part in the study if you have a history of seizures and/or are pregnant.

This study will investigate research questions regarding factors influencing patient-provider communication. Participants will interact with a virtual patient in a virtual clinical setting.

Third- or fourth-year medical students may be eligible for this study. Participants are recruited from the Washington, D.C. area.

Study participants will perform one task and complete one set of questions at the study appointment. The task involves viewing a virtual patient s health information and interacting with the virtual patient in a virtual environment clinical scenario. While in the virtual environment, the subject wears a head-mounted video unit that allows him or her to see elements of the environment. The activities in the virtual environment take about 15 minutes. The total time for the study is about 60 minutes.

Eligibility Criteria:
* INCLUSION CRITERIA:

Healthy adult volunteers who are third or fourth-year medical students. Both men and women over age 18 will be eligible for this study (though in practice the age range is likely to naturally be constrained by the typical age of medical students).

EXCLUSION CRITERIA: 1) persons with seizure or vestibular disorders; 2) women with known pregnancy; 3) persons who are highly prone to motion sickness; 4) those with low, uncorrected vision or hearing; 5) all current and past employees and contractors of

NHGRI; and 6) persons who have received information about the study purpose or procedure from a past participant.
Cornell Translational Behavioral Science Research Consortium: Hypertension Qualitative Study

To explore the meaning, causes and treatment of hypertension in eligible patients. In addition the cultural, social, and psychological factors that either facilitate or serve, as barriers to behavioral change will be illuminated in this patient population.

1. The first goal is to explore the meaning, causes and treatment of hypertension in eligible patients. In addition the cultural, social, and psychological factors that either facilitate or serve, as barriers to behavioral change will be illuminated in this patient population. Through a series of open-ended questions we will explore and build a better understanding of how hypertensive African American patients view their illness and the difficulties they have in taking their antihypertensive medications as prescribed.
2. The second goal of the qualitative phase is to use the responses obtained to inform how we should operationalize and tailor the positive affect induction and self-affirmation intervention methods in hypertensive African American patients.

Eligibility Criteria:
Inclusion Criteria:

1. Patients must be self-identified as African-Americans.
2. All patients must be aged 18 years and older.
3. All patients must be diagnosed as having hypertension: For this project, hypertension will be defined according to the widely accepted criteria of the 6th Joint National Committee (JNC VI) Guidelines on Prevention, Detection, Evaluation and Treatment of Hypertension, which is a systolic blood pressure \> 140 mm hg or a diastolic blood pressure \> 90 mm hg or if participants are taking any prescribed antihypertensive medication.
4. Patients must be able to provide informed consent in English.

Exclusion Criteria:

1. Patients who refuse to participate
2. Patients who are unable to provide informed consent.
hTERT Immunotherapy Alone or in Combination With IL-12 DNA Followed by Electroporation in Adults With Solid Tumors at High Risk of Relapse

This is a Phase I, open label study to evaluate the safety, tolerability, and immunogenicity of INO-1400 or INO-1401 alone or in combination with INO-9012, delivered by electroporation in subjects with high-risk solid tumor cancer with no evidence of disease after surgery and standard therapy. Subjects will be enrolled into one of ten treatment arms. Subjects will be assessed according to standard of care. Restaging and imaging studies will be performed to assess disease relapse per NCCN guidelines. RECIST will be used to validate the findings in cases of relapse.


Eligibility Criteria:
Inclusion Criteria:

* 1. Signed and dated written IRB approved informed consent;
* 2. Males or females aged ≥18 years;
* 3. Subjects with breast, lung or pancreatic carcinoma who are at high risk of relapse post definitive therapy at least 4 and no more than 24 weeks from completion of definitive therapy at the time of signing informed consent as described below for each indication:

  * Breast carcinoma:
  * Lung carcinoma:
  * Pancreatic carcinoma:
  * Head and neck squamous cell carcinoma:
  * Ovarian cancer:
  * Colorectal cancer
  * Gastric and esophageal cancer
  * Hepatocellular carcinoma

Exclusion Criteria:

* 1. Previous treatment wth any TERT or IL-12 containing therapy, or any other DNA immunotherapy;
* 2. Any concurrent condition requiring the continued or anticipated use of systemic steroids (excluding non-systemic inhaled, topical skin and/or eye drop-containing corticosteroids) or immunosuppressive therapy (excludes low dose methotrexate). All other systemic corticosteroids must be discontinued at least 4 weeks prior to first Study Treatment;
* 3. Administration of any vaccine within 4 weeks of the first study treatment
Neoadjuvant FOLFOXIRI Versus CapeOX Chemotherapy for Local Advanced Rectal Cancer

This is a phase III randomized controlled trial comparing the efficacy and safety of FOLFOXIRI versus CapeOX as neoadjuvant regimen in treating patients with middle and upper locally advanced (MRI T3-4 or N+) rectal cancer. This study aims to optimize the neoadjuvant therapy for patients with anus-preserving resectable locally advanced rectal cancer, so as to improve the prognosis of them. It remains unclear about whether FOLFOXIRI or CapeOX neoadjuvant chemotherapy is more effective for locally advanced rectal cancer.


Eligibility Criteria:
Inclusion Criteria:

* MRI evaluated of T3-4 or N+ rectal cancer;
* Pathologically diagnosed of rectal adenocarcinoma;
* 18 to 75 years old;
* Distance from lower margin of tumor to anus \<15 cm and suitable for anus-preserving resection;
* Tumor amenable to radical resection;
* Treatment-na?ve patients with no previous systemic chemotherapy, radiotherapy or local excision for treating rectal cancer;
* Laboratory requirements conducted within 7 days of starting study treatment: Neutrophil count ≥ 1.5×10\^9/L, Platelet count ≥ 100×10\^9 /L, Hemoglobin ≥ 80 g/L, Serum bilirubin ≤ 24umol/L, Alanine aminotransferase and aspartate aminotransferase ≤ 60 U/L, Serum creatinine ≤ 110 umol/L;
* Be capable to receive a surgery;
* No second tumor at present or in the past 5 years, except skin basal cell carcinoma, skin squamous cell carcinoma, or any in situ cancer;
* No previous systemic chemotherapy for treating colorectal cancer;
* Life expectancy of more than 3 months;
* No current pregnancy or breast-feeding, and subjects at childbearing age shall take method of contraception;
* Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≤ 1;
* Be willing and able to understand the study and to provide written informed consent.

Exclusion Criteria:

* End-stage cachexia patients;
* Cardiopulmonary dysfunction or liver and kidney dysfunction, and unable to tolerate chemotherapy or surgery;
* Metastatic carcinoma;
* Incomplete or complete intestinal obstruction;
* Known to be allergic to capecitabine, 5-Fu, oxaliplatin or irinotecan;
* Pregnant or lactating women; or women who have fertility but have not taken at taken adequate contraceptive measures;
* Have vital organ failure or other severe diseases, including but not limited to coronary heart disease, cardiovascular diseases, or myocardial infarction within 12 months before being included; severe neurological or psychiatric historysevere infection; active disseminated intravascular coagulation; active hepatitis, severe coagulation disorder patients;
* History of other malignancy within the past 5 years except effectively treated skin basal cell carcinoma, skin squamous cell carcinoma, or any in situ cancer;
* Serious organic disease including but not limited to heart, kidney, brain, and lung.
Clinical Outcomes of Preservation Versus Resection of Portal/Superior Mesenteric Vein During Pancreaticoduodenectomy in Pancreatic Cancer Patients Who Respond to Neoadjuvant Treatment

1. There is a lack of evidence on the need to perform portal/superior mesenteric vein (PV/SMV) resection routinely in pancreatic ductal adenocarcinoma (PDAC) patients with venous involvement who responded to neoadjuvant treatment (NAT).
2. There is no significant differences in R0 rate, 5-year overall survival and recurrence-free survival between the PV/SMV preservation (PVP) group and PV/SMV resection (PVR) group.
3. PVP group showed significantly better 5-year PV/SMV stenosis free survival than the PVR group.
4. We propose that if dissection is possible and there is a high likelihood of achieving R0 resection after NAT, routine PVR may be unnecessary in PDAC patients with venous involvement.


Eligibility Criteria:
Inclusion Criteria:

* Pancreatic head cancer patients who underwent surgery after neoadjuvant treatment between January 2012 and December 2022 at Seoul National University Hospital

Exclusion Criteria:

* Metastatic unresectable and locally advanced pancreatic cancer
* Resectable pancreatic cancer without portal/superior mesenteric vein invasion
* Cancer aggravation after neoadjuvant treatment
* Portal/superior mesenteric vein encasing and narrowing after neoadjuvant treatment
* Patients who underwent palliative surgery
* Non-pancreatic ductal adenocarcinoma patients
* Patients who death within 30 days of surgery
* Loss of follow-up patients
* Patients who underwent resection for suspected main artery and adjacent organ invasion
Tumors of the Peripheral Nervous System

The goal of this observational study is to individuate tumors' and patients' features influencing the outcome after surgical tumor removal.

Patients operated because of removal of Peripheral Nervous System (PNS) tumor will be recruited accordingly to the inclusion criteria: the aims of the study will be illustrated and the informed consent signed.

All the clinical and neuroradiological perioperative documents of the enrolled patients will be analyzed. As follow-up, thorough neurological exam wil be performed and specific surveys about after surgery social and working life will be administered; neuroradiological imaging will be performed.

Then, the results will be investigated to individuate which factors were related to the outcome.

Eligibility Criteria:
Inclusion Criteria:

* ≥ 18 y.o.
* neurosurgical removal of peripheral nerve tumor at our University Hospital "Fondazione Policlinico Universitario Agostino Gemelli (FPG)" during the previous 10 years
* signed consent to study participation

Exclusion Criteria:

* \< 18 y.o.
* neurosurgical treatment because other causes (chronic entrapment syndromes, acute nerve lesion)
* denied consent to study participation
Monitoring Platelet Function During Continuous Hemodialysis

Aim of the study is a description of changes in platelet function during continuous veno-venous hemodialysis or hemofiltration in patients on an intensive care unit using the Multiplate system.


Eligibility Criteria:
Inclusion Criteria:

* Need for a continuous renal replacement therapy
* Platelet Count \>100.000/nl

Exclusion Criteria:

* Pregnancy
* Age \<18 years
* Renal replacement therapy within the 7 days prior to enrollment
The Association Between Restricted Ankle Joint Dorsiflexion and Dynamic Knee Valgus

The purpose of this study was to analyze if a low ankle dorsiflexion range is associate with dynamic knee valgus in youth basketball players.

Cross-sectional study. Ankle dorsiflexion range of motion was assessed by the Weight-bearing lunge test and the dynamic knee valgus by the Single leg squat test.

The participants were basketball players who belonged to youth basketball de-velopmental teams in the under-12 (U12), under-14 (U14), under-16 (U16) and under-17 (U17) categories. All participants were recruited by means of simple random sampling from the Catalan Basketball Federation during the 2018-2019 season. The participants were classified according to gender and age as stipulated by the rules determined an-nually for the respective official competitions. The study was carried out in the facilities of each club. The inclusion criteria were being age \>12 and ≤17 at testing and actively competing during the study. Subjects were excluded if they had sustained any type of injury in the lower limbs before screening; presented any injury (overuse or acute) at the time of testing; if they had any oncological, psychological and/or psychiatric illnesses; or if they did not attend on the day of the assessment.

Eligibility Criteria:
Inclusion Criteria:

* Being age \>12 and ≤17 at testing and actively competing during the study

Exclusion Criteria:

* Subjects were excluded if they had sustained any type of injury in the lower limbs before screening; presented any injury (overuse or acute) at the time of testing; if they had any oncological, psychological and/or psychiatric illnesses; or if they did not attend on the day of the assessment.
Correlation Between Objective Skin Pigment Measurement and Fitzpatrick Skin Type

The purpose of this study is to correlate subjective skin pigment measurements as reported by patient-responses to the Fitzpatrick Skin Type Scale versus objective classification of skin pigment utilizing Individual Typology Angle (ITA) measurements.

The Fitzpatrick scale is a numerical classification for human skin color developed in 1975 as a way to estimate the response of different types of skin to UV light. It is used by dermatologists to classify skin tone and assess the risk of skin cancer.

The Fitzpatrick scale encompasses six gradings, from I to VI. However, this does not include all skin tones, as there are significantly more not encompassed within the scale. The aim of this study is to incorporate objective measurements when identifying a patient's Fitzpatrick skin type.

Eligibility Criteria:
Inclusion Criteria:

* Male and females that are 18 years of age and older
* Subjects with all Fitzpatrick skin types I-VI One-third of subjects will be Fitzpatrick I or II skin types, one-third of subjects will be III or IV, and one-third will have V and VI.

Exclusion Criteria:

* Individuals who are pregnant or breastfeeding.
* Prisoners
* Adults unable to consent
* Individuals with open wounds on the nondominant upper inner arm
* Individuals with fibrotic skin disease or other skin conditions or hair growth on the nondominant upper inner arm that could affect skin measurements in the opinion of the investigator
* Individuals with tattoos that cover the site on the nondominant upper inner arm
* Individuals with post-inflammatory hypopigmentation or hyperpigmentation
* Individuals with vitiligo
* Individuals who have used self-tanning products or tanning beds in the last two weeks.
Laparoscopic Occlusion of Uterine Vessels Compared to Uterine Fibroid Embolization for Treatment of Uterine Fibroids

Women with symptomatic uterine fibroids are treated either by Uterine Fibroid Embolization (UFE) or laparoscopic occlusion. The study hypothesis is that laparoscopic occlusion of uterine vessels and UFE have equal effect on bleeding symptoms. Menstrual bleeding reduction six months after treatment is the main endpoint. Secondary endpoints include participants assessment of symptom relief, and volume reduction of fibroids measured by MRI. We will also investigate possible differences in postoperative course, symptom reduction, complication, and recurrence. Patients are controlled with regular intervals up to five years after treatment.

Uterine fibroid embolization (UFE)has become an alternative to hysterectomy for women with symptoms of uterine fibroids.Follow up studies of this new method have reported relief of menstrual bleeding by 85-90 % of the patients six to twelve months after treatment.Other studies have suggested laparoscopic bilateral occlusion of uterine arteries as an equal effective alternative, but to our knowledge there is no randomized studies published.

Patients recruitment : Women with symptoms of uterine fibroids referred to the clinic,who express a desire to avoid hysterectomy.

Study hypothesis: Laparoscopic occlusion of uterine vessels and UFE have equal effect on bleeding symptoms.

Gynecological examination, ultrasonography and magnetic resonance imaging (MRI) are performed preoperatively and after 1,3 and 6 months. Clinical follow up is planned after 1,3,6,12,24,36 and 60 months.A validated bleeding chard, Pictorial Blood Assessment Chart(PBAC)is filled in by the participants during the last menstruation period before treatment and before each control. A standardized questionnaire to assess the bleeding amount,pressure symptoms, pain, adverse events, other complains and patients satisfaction is also used.

Eligibility Criteria:
Inclusion Criteria:

* Menorrhagia and/or bulk symptoms associated with uterine fibroids

Exclusion Criteria:

* Malignancy
* Current or planned pregnancy
* Small submucous fibroids suitable for hysteroscopic resection
* Postmenopausal women
* Suspected or known adenomyosis
* Uterus size exceeding the umbilical level
* Contraindications against laparoscopic surgery
A Trial of the ALK Grass Tablet in Subjects With Hayfever

This trial is performed to assess the efficacy and safety of the ALK Grass tablet for treatment of grass pollen induced rhinoconjunctivitis (hayfever).


Eligibility Criteria:
Eligibility Criteria:

* A history of grass pollen induced rhinoconjunctivitis
* Positive skin prick test to grass
* Positive specific IgE to grass
Assessment of Cognitive and Functional Impairment in Older Patients After ERCP

Endoscopic retrograde cholangiopancreatography (ERCP) is an interventional endoscopy procedure utilized in the therapeutic management of pancreatobiliary diseases including gallstones, bile duct strictures, leaks and infections, pancreatitis, and cancers of the bile duct or pancreas. ERCP is classified as a high risk procedure. Potential adverse events directly attributable to the technical aspects of ERCP include pancreatitis, hemorrhage, infection, and bowel wall perforation. Other potential adverse events of ERCP may be less apparent and/or unknown, such as risk of neurocognitive dysfunction. Overall, neurocognitive dysfunction after medical procedures impacts quality of life, functional disability, depression, and caregiver and societal burden.

The prevalence of postoperative neurocognitive dysfunction and disability following interventional endoscopy procedures such as ERCP has not been reported. This prospective observational study is designed to assess the prevalence of cognitive impairment and functional disability after ERCP and endoscopic ultrasound (EUS) procedures in older patients, and to assess whether specific patient and/or procedural factors are associated with increased risk of adverse outcomes.


Eligibility Criteria:
Inclusion Criteria:

* Adults aged 60 years or older
* Scheduled to undergo outpatient ERCP and/or EUS at Vanderbilt University Medical Center (VUMC)

Exclusion Criteria:

* Age \<60 years
* Inpatient status at the time of ERCP/EUS
* Documented history of dementia
* Inability to provide informed consent for study participation, implying baseline neurocognitive dysfunction
* Blind, deaf, or unable to speak English, as these conditions would preclude our ability to perform assessments.
* No access to a telephone to permit pre-procedure and 3 month post-procedure neurocognitive assessment