cyrilzakka/clinical-trials huggingface dataset:
Assessment of Palatal Mucosal Thickness in Different Vertical Skeletal Pattern: a 3D Analysis

This study assesses the potential statistical correlation between vertical facial pattern and palatal mucosa thickness.

Data collection : dicom files (CBCT) merged with STL files of n patients for soft tissue visualization

Aim: to volumetrically assess (with CBCT) the palatal mucosa thickness in different vertical facial types to aid clinicians in the planning and placement of orthodontic miniscrews.

Hypothesis : There is no significant difference between the 3 groups studied (i.e. no correlation between palatal mucosa thickness and vertical facial typology).

Study rationale : The use of palatal miniscrew offers the possibility to improve the effectiveness of orthodontic expansion devices. Palatal expanders supported by miniscrew can be applied with different clinical protocols. The palatal mucosa thickness affects the choice of miniscrew length.

Justification for overlaying on STL files: When the lingual dorsum and palatal mucosa are in mutual contact during CBCT examination, it is not possible to distinguish one from the other during subsequent imaging evaluation. Various methods have been proposed to overcome these limitations, including the superimposition of the dicom and stl files: this methodology enables the profile of the palatal mucosa to be distinctly identified in all the analyzed scans.

Eligibility Criteria:
Inclusion Criteria:

* Full permanent dentition (except for third molar)
* Normal craniofacial development
* Aged \> 16 years
* Complete skeletal maturity (assessed by the cervical vertebral maturation method)
* Absence of previous orthodontic or orthognatic surgical treatment

Exclusion Criteria:

* Absence of any tooth other than the third molar
* Maxillary impacted tooth
* CBCT scans taken without teeth in occlusion/open bite
* Distorting pathologies of the facial mass affecting the palatal zone
* Periodontal or endodontic diseases affecting the bone
* Presence of metallic artifact
* History of previous orthognatic or orthodontic surgeries
Evaluating Efficacy and Tolerability of Anticancer Drug Therapies for the Treatment of Gynecologic and Breast Cancers

retrospective/prospective observational study. Objective of the study is to evaluate the effect of drugs in terms of objective responses, disease-free survival (DFS), progression-free survival (PFS), overall survival (OS), and side effects compared with registry studies in the medical therapy of breast and gynecologic cancers.

This is a single-center retrospective/prospective observational study. Objective of the study is to evaluate the effect of drugs in terms of objective responses, disease-free survival (DFS), progression-free survival (PFS), overall survival (OS), and side effects compared with registry studies in the medical therapy of breast and gynecologic cancers.

Regarding the prospective component of the study, it is clarified that therapy will be warranted by clinical practice regardless of study enrollment. Diagnostic investigations will also be conducted as per normal practice; enrollment in the study does not require additional examinations.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of histologically confirmed breast cancer or gynecological cancer, either early stage or metastatic;
* Patients who have received treatment for breast cancer or gynecologic cancer since January 2010;
* Any patient currently living and actually contactable must sign an informed consent to the study and processing of personal data.

Exclusion Criteria:

* no exclusion criteria
Band Holiday Study

AIMS: Our aims are to measure BMI and plasma concentrations of representative hormones before and after a band holiday, in addition to surveying hunger/satiety and behavior changes.

AIMS: Our aims are to measure BMI and plasma concentrations of representative hormones before and after a band holiday, in addition to surveying hunger/satiety and behavior changes.

Materials and Methods:

Adults ≥ 18 years of age who previously underwent LAGB at New York University Medical Center and have lost sufficient excess body weight and agree to have their band temporarily loosened for a 2 week period will be invited by the health care provider to participate. Patients of both genders and all races are eligible for participation. Patients will need to consent to complete a questionnaire and to have blood drawn when the band is loosened and refilled. Patients will only be excluded if they are not willing to have their band loosened or if they will not present for follow-up.

Sample size:

For this pilot program we plan to enroll 15 patients. Since patients will serve as their own controls before and after meals as well as before and after band adjustments, we anticipate adequate power to assess for significant variations.

Eligibility Criteria:
Inclusion Criteria:

* Adults ≥ 18 years of age
* who previously underwent LAGB at New York University Medical Center and have lost sufficient excess body weight and
* agree to have their band temporarily loosened for a 2 week period will be invited by the health care provider to participate.

Exclusion Criteria:

* \< %35 Excess weight loss
Pre- vs. Postoperative Scalp Block for Pain Control After Supratentorial Craniotomy

Study was designed to evaluate optimal timing for selective scalp block in patients undergoing general anesthesia for supratentorial craniotomy.Pain score assessed by visual analog scale (VAS) preoperatively (baseline) and after extubation at 2, 6, 12 and 24 hours; time first request of a patient for rescue analgesia; intraoperative anesthetics and opioids consumption; awakening time; perioperative complications.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients (\>18 years),
* presenting with supratentorial brain tumors scheduled for elective craniotomy under general anesthesia

Exclusion Criteria:

* history of allergic reactions on local anesthetics;
* ASA status ≥ 3;
* depressed consciousness in pre- or postoperative period;
* aphasia (as investigators were not able to obtain VAS score).
Running Effect on Cardiovascular and Muscular Parameters

The purpose of the study is to determine the effect of 16 weeks of running exercise on various parameters related to heart, vascular systems, blood, and muscle in untrained males 30-50 years old.

Further, the investigators assess which of the above mentioned parameters may explain the increase of running performance most accurate.


Eligibility Criteria:
Inclusion Criteria:

* males
* untrained (\< 2 endurance exercise sessions/week)
* 30-50 years old

Exclusion Criteria:

* pathological changes of the heart
* inflammable diseases
* medication/diseases affecting cardiovascular system and muscle
* very low physical capacity (\< 100 Watt at ergometry)
* obesity (BMI \> 30 kg/m2)
* more than 2 weeks of absence during the interventional period
* more than 2 exercise session beside the intervention
* contraindication related to MRI-assessment (i.e. claustrophobia, magnetizable intracorporal artefacts)
Glutamate Excitotoxicity and Its Role in Glioblastoma Biology

Gliomas are the most frequent type of primary brain tumors in adults; among them glioblastoma multiforme (GBM) is the most malignant, being associated with the worst prognosis. Glutamate (Glu) is an aminoacid, responsible for essential functions in the Central Nervous System (CNS), acting both as metabolite and neurotransmitter. It is essential for regulating cellular metabolism and developmental synaptogenesis, cellular migration, differentiation and death. Recent scientific evidences have demonstrated alteration in Glu synthesis and signaling being directly involved in GBM growth and invasion

Glu and its scavenger's levels are measurable both in serum and in the cerebral-spinal fluid (CSF), thus making them ideal markers for tumor aggressiveness and disease activity as well as a potential target for new therapeutic approaches.

Serum and CSF levels of glutamic oxaloacetic transaminase (GOT1), Glutamate Pyruvate Transaminase (GPT) and glutamate and aspartate levels of a total of 40 patients will be collected.

Molecular biology analyses will be conducted and oncological and imaging data will be collected during follow-up in patients enrolled in the present studies. MRI imaging as well as blood sampling will be performed at definite timepoints (baseline and 3, 6 and 9 months follow-up).

Eligibility Criteria:
Inclusion Criteria:

* Adult patients with a brain lesion suspected for GBM, candidate to gross total tumor resection (GTR), followed by radiotherapy and chemotherapy (concomitant and adjuvant).
* Patient able to provide informed consent.

Exclusion Criteria:

* Age \< 18 years
* Liver disease
* Severe anemia (Hb \<8mg/dl)
* Pregnancy
Study of the Effect of VX-770 on Hyperpolarized Helium-3 Magnetic Resonance Imaging in Subjects With Cystic Fibrosis and the G551D Mutation

Cystic Fibrosis (CF) is caused by mutations in the cystic fibrosis transmembrane conductance regulator (CFTR) gene. The encoded protein, CFTR, is an epithelial chloride ion channel responsible for aiding in the regulation of salt and water absorption and secretion in various tissues. Although the disease affects multiple organs, the leading cause of mortality is the progressive loss of lung function. Obstruction of airways with thick mucus, chronic bacterial infection of the airways, and inflammatory response are all thought to play a role in causing lung damage. Through its function as a chloride channel, CFTR is believed to be integral in epithelial ion and water transport and hence, maintaining the normal hydration of lung secretions.

VX-770 (ivacaftor) is a potent and selective potentiator of wild-type, G551D, F508del, and R117H forms of human CFTR. Based on in vitro studies and pharmacologic, pharmacokinetic (PK), and safety profiles, VX-770 has been selected for clinical development as a possible treatment for patients with CF.

Hyperpolarized noble gas magnetic resonance imaging (HG-MRI) is a promising new means of assessing lung function by direct imaging of certain non-radioactive isotopes of an inert noble gas, such as helium or xenon. Through this technique, high-resolution 3-dimensional images of lung ventilation can be obtained in both pediatric and adult patients during a single short breath-hold following inhalation of the gas.

This is a 2-part study to evaluate the effect of VX-770 on hyperpolarized helium-3 magnetic resonance imaging (3He-MRI), and to evaluate the safety and efficacy of VX-770 in subjects aged 12 years and older with CF who have the G551D-CFTR mutation. Part A is a single-blind, placebo-controlled study that includes 4 weeks of VX-770 treatment and 4 weeks of placebo treatment. Part B is an open-label, 48 week study of long-term effect of VX 770 on hyperpolarized 3He-MRI.


Eligibility Criteria:
Inclusion Criteria:

* Male or female with Cystic Fibrosis
* Must have the G551D-CFTR mutation on at least 1 allele
* FEV1 ≥40% of predicted normal for age, gender, and height at Screening
* 12 years of age or older
* Must be able to swallow tablets

Exclusion Criteria:

* History of solid organ or hematological transplantation
* Ongoing participation in another therapeutic clinical study or prior participation in an investigational drug study within the 30 days prior to screening
* Use of inhaled hypertonic saline treatment within 14 days prior to the Screening Visit
* Extensive body tattoos or other physical features that will confound MRI
Optimization of a Digital Self-guided Psychological Intervention for Insomnia: A Randomized Factorial Experiment

In a previous pilot study, a digital self-guided intervention for insomnia showed preliminary positive effects on insomnia symptoms. In order to optimize the digital self-guided format, this study will evaluate the added value of three treatment features on treatment engagement and insomnia symptoms. The participants will be adults with insomnia. The trial will be a 2x2x2 randomized factorial experiment, where the following features/factors will be manipulated: an optimized graphical user interface (yes or no), an adaptive treatment strategy (yes or no), and daily prompts to use the intervention (yes or no). The factorial experiment will create 8 equally large groups (1:1:1:1:1:1:1:1), who will receive the different combinations of features. The main outcome will be the effect on treatment engagement.


Eligibility Criteria:
Inclusion Criteria:

1. ≥ 18 years of age.
2. ≥ 15 points on Insomnia Severity Index.
3. Insomnia diagnosis, according to criteria in the Diagnostic and Statistical Manual of mental disorders-5 (somatic/psychiatric comorbidity is allowed).
4. Good understanding of the Swedish language.
5. No practical obstacles to participate in treatment and assessments.
6. Daily access to computer/smart-phone/tablet with Internet access.
7. Can receive phone calls and text messages during the study period.

Exclusion Criteria:

1. Sleep diseases, such as narcolepsy or sleep apnea.
2. Somatic or psychiatric illnesses that either are directly contraindicated for the treatment, require other treatment, or entail symptoms/a functional level making it too difficult to participate in the study.
3. Alcohol/drug abuse, or medication with side effects on sleep (however, sleep medication is allowed).
4. Working nights or night shifts.
Prevalence and Natural History of Functional Gastrointestinal Disorders Among At-risk Infants.

The goal of this observational study is to learn about the prevalence and characteristics of functional gastrointestinal disorders (FGID) in at risk infants (former preterm infants and those with birth asphyxia) during the first 2 years of life. The main questions it aims to answer are:

* evaluate the prevalence of symptoms related to gastro-esophageal reflux (GER), of functional gastrointestinal disorders during the first 2 years of life
* describe growth parameters during follow-up up to the corrected age of 2 years Participants will be assessed clinically and with a structured questionnaire based on the Rome IV criteria to describe FGID.

Infants will undergo clinical assessment at 3, 6, 12, 24 months' corrected age at the local Follow-up clinic.

Clinical examination, anthropometric measurement and data from a structured questionnaire to detect FGID will be performed.

Z-scores for weight, length and head circumference will be calculated according to the World Health Organization (WHO) standards.

Data from the questionnaires will be collected. Clinical characteristics of patients and perinatal data will be collected and analyzed by appropriate statistical methods.

The prevalence and characteristics of FGID in the study population will be compared to published data (mostly from term infants).

Eligibility Criteria:
Inclusion Criteria:

* infants with gestational age at birth \< 31 weeks
* infants with gestational age at birth \< 37 weeks and major respiratory or neurologic morbidity
* infants with history of perinatal asphyxia

Exclusion Criteria:

* lack of informed consent
* diagnosis of congenital or other major gastrointestinal disease (i.e. inflammatory bowel disease, cancer)
Safety and Efficacy of Human Umbilical Cord Derived Mesenchymal Stem Cells for Treatment of HBV-related Liver Cirrhosis

HBV related Liver disease is a common medical problem in China. An estimated 7.18% of the Chinese (about 93 million) is infected with hepatitis B, and most of the HBV- related hepatitis can developed into liver cirrhosis.

Liver transplantation is the only available life saving treatment for patients with end stage liver disease. However, lack of donors, surgical complications, rejection, and high cost are serious problems.

Mesenchymal stem cells (MSCs) possess plasticity and have the potential to differentiate into hepatocyte; Thus, MSCs hold great hope for therapeutic applications. Human umbilical cord-derived MSCs (hUC-MSCs) exhibit a more beneficial immunogenic profile and greater overall immunosuppressive potential than aged bone marrow-derived MSCs. Like MSCs derived from bone marrow, hUC-MSCs can also be used to treat rat liver fibrosis and improve glucose homeostasis in rats with liver cirrhosis. In this study, the patients with HBV-related liver cirrhosis will undergo administration of hUC-MSCs via hepatic artery to evaluate the safety and efficacy of hUC-MSC treatment for these patients.


Eligibility Criteria:
Inclusion Criteria:

1. Aged 18-65 years
2. HBV-related liver cirrhosis
3. Child-Pugh score 9-15
4. Written consent -

Exclusion Criteria:

1. Hepatocellular carcinoma or other malignancies
2. Severe problems in other vital organs(e.g.the heart,renal or lungs)
3. Pregnant or lactating women
4. Severe bacteria infection
5. Anticipated with difficulty of follow-up observation
6. Other candidates who are judged to be not applicable to this study by doctors
Comparative Formulation Study of Vabicaserin

This study will compare two different formulations of vabicaserin.


Eligibility Criteria:
Inclusion Criteria:

* Sexually active men must agree to use a medically acceptable form of contraception during the study and continue it for 12 weeks after investigational product administration.
* Nonsmoker or smoker of fewer than 10 cigarettes per day as determined by history. Must be able to abstain from smoking during the inpatient stay.

Exclusion Criteria:

* Use of any investigational or prescription drug within 30 days before investigation product administration.
* Consumption of any caffeine-containing products (eg, coffee, tea, chocolate, or soda) or alcoholic beverages within 48 hours before study day 1.
* Use of any over-the-counter drugs, including herbal supplements within 72 hours before study day 1.
A Study to Evaluate How Aprocitentan is Safe and How it is Absorbed and Broken Down in the Body of Japanese and Caucasian Subjects

The objective of this study is to evaluate the tolerability, safety, and pharmacokinetics after multiple-dose administration of aprocitentan (25 mg) in healthy Japanese and Caucasian subjects.


Eligibility Criteria:
Inclusion Criteria:

* Subjects must be of Caucasian or Japanese ethnicity
* Signed informed consent in a language understandable to the subject prior to any study-mandated procedure
* Body mass index (BMI) of 18.0 to 28.0 kg/m2 (inclusive) at Screening
* Systolic blood pressure 100-145 mmHg, diastolic blood pressure 50-90 mmHg, and pulse rate 45-90 bpm (inclusive), measured on the same arm, after 5 min in the supine position at Screening
* A woman of childbearing potential is eligible only if the following applies:

Negative serum pregnancy test at Screening,

Negative urine pregnancy test on Day -1,

Agreement to consistently and correctly use a reliable method of contraception from Screening up to at least 30 days after last study treatment administration

Japanese subjects only

* Subjects must be of native Japanese descent (all parents/grandparents of Japanese descent).
* Subjects must not have been away from Japan for more than 10 years (at Screening visit).
* Subject's lifestyle should not have changed significantly since relocation from Japan

Exclusion Criteria:

* Previous exposure to aprocitentan and/or macitentan.
* Known hypersensitivity to aprocitentan or treatments of the same class, or any of the excipients
* Pregnant or lactating women
* Any circumstances or conditions, which, in the opinion of the investigator, may affect full participation in the study or compliance with the protocol
RadIal Versus Femoral InvEstigation in ST Elevation Acute Coronary Syndrome

Prospective, randomized, multi-center trial comparing the safety and efficacy in the prevention of net adverse clinical outcomes (NACE) of transfemoral vs. transradial approach for the treatment of patients with ST-elevation acute coronary syndrome (STEACS) undergoing primary angioplasty

Prospective, randomized, double arm study. The study population will include all consecutive patients presenting with a ST-elevation Acute Coronary Syndrome and candidates for primary percutaneous coronary intervention, who agree and provide written informed consent for the study.

Before arterial stick for percutaneous access, patients will be randomized according to sealed numbered envelopes. Subsequently, arterial access will be obtained and the diagnostic/interventional procedure will be performed according to routine clinical practice, leaving ancillary medications, choice of devices and means of hemostasis at the physician's discretion.

In the randomization process all participating centers will be equally stratified to avoid statistical unbalance.

Eligibility Criteria:
Inclusion Criteria:

1. Subject is \>18 years old with recent acute ST-elevation acute coronary syndrome (STEACS) requiring emergent coronary angiography.
2. Patient has no contraindication to percutaneous arterial access by both and transfemoral route.
3. Subject has been informed of the nature of the study and agrees to its provisions and has provided written informed consent as approved by the Institutional Review Board/Ethics Committee of the respective clinical site.
4. Patient and the treating physician agree that the subject will comply with all follow-up evaluations.

Exclusion Criteria:

1. Subject's age is \<18 years and he has no acute ST-elevation myocardial infarction (ST elevation of a least 0.1 mV in ≥2 extremity leads or at least 0.2 mV in ≥2 precordial leads).
2. Subject has had a recent stroke or TIA (\<4 weeks), irrespective of age.
3. Patient has an international normalized ratio (INR) \> 2.0, or other severe bleeding diathesis
4. The patient is pregnant or breastfeeding.
5. Known allergies to: aspirin, clopidogrel and ticlopidine, heparin, IIb/IIIa inhibitors, stainless steel, or contrast agent (which cannot be adequately premedicated).

7.Subject is currently participating in an investigational drug or device study that has not completed the primary endpoint or that clinically interferes with the current study endpoints.

8.Prior participation in this study.
Study Evaluating The Effect Of Ramipril On Urinary Protein Excretion In Renal Transplant Patients Converted To Sirolimus

The primary objective of the study is to determine the efficacy of ramipril in preventing a urinary protein to creatinine ratio (U p/c) greater than 0.5 following conversion to sirolimus from a calcineurin inhibitor (CNI) in maintenance kidney transplant patients.


Eligibility Criteria:
Inclusion Criteria:

* Receiving cyclosporine (CsA) or tacrolimus (TAC) since the first month post-transplant.
* In addition to a calcineurin inhibitor (CNI), subjects must be treated with either corticosteroids at a dosage range of 2.5 to 15 mg/day for prednisone or prednisolone (2 to 12mg/day for methylprednisolone or the alternate day equivalent) or a steroid-free regimen for a minimum of 12 weeks before randomization or either MMF (\>/=500mg/day), mycophenolate sodium (MPS) (\>/=360 mg/day) or AZA (\>/=50mg/day). Subjects must be taking a minimum of 2 immunosuppressive drugs if on a steroid-free regimen.
* Subject is 3 to 60 months after renal transplantation.
* Subject is greater than 12 weeks after treatment for any acute rejection.

Exclusion Criteria:

* Subjects who are currently receiving, or have received within 4 weeks before enrollment, RAAS blockade.
* Subjects with a calculated GFR \< 40mL/min (per the Modification of Diet in Renal Disease \[MDRD-7\] or abbreviated MDRD formula).
* Subjects with a urine protein to creatinine ratio (U p/c) of \>0.3.
* Subjects with a history of uncontrolled systolic blood pressure (SBP \>140 mm Hg).
* Subjects with severe hepatic impairment (Grade C Child-Pugh score). Additional Inclusion / Exclusion Criteria apply.