cyrilzakka/clinical-trials huggingface dataset:
A Volume, Motion, and Anatomically Adaptive Approach to Photon and Proton Beam Radiotherapy

This pilot study will determine changes over time in tumor volume/motion \& patient anatomy, as well as dose distributions to normal organs. The study will inform medical decision-making about need for (and timing of) re-calibration of radiation dosimetry plans. Weekly CT and/or serial MR scans will be employed for those patients receiving 7-8 wks of radiation therapy. The study will enroll 30 patients in each stratum: Non small cell lung cancer (NSCLC), Head \& Neck, gastrointestinal (GI) and Gynecologic tumor.

This is a pilot study to estimate the degree of tumor volume, tumor motion and patient anatomy change during treatment with photon or proton beam radiotherapy. Patients will undergo simulation with an MR scan and/or CT scan per best clinical practices, and 4D imaging will be employed as indicated, at the discretion of the treating radiation oncologist. Photon beam treatment plans and Proton beam treatment plans will be generated from these images. Based on the location of the primary tumor, patients will undergo either up to weekly 3D or 4D CT and/or serial MR scans during treatment. These images will be compared to the initial CT/MR scans used for treatment planning and analyzed for changes in tumor volume and tumor anatomic location. At the end of treatment, the frequent 3D or 4D CT and/or serial MR images will be compared to the initial treatment planning images to quantify the changes in tumor volume and tumor motion during the course of radiation treatment. Each CT and/or MR Scan will also be used to evaluate the changes in dose distribution to the target volumes and normal tissues that occur with the initial photon treatment plan and initial proton treatment. The changes in tumor volume, tumor motion and dose distribution during the course of radiation treatment will be analyzed to determine the effect of tumor changes on radiation treatment efficacy.

Eligibility Criteria:
Inclusion Criteria:

* Aged 18 and above.
* Biopsy proven diagnosis of non-small cell lung cancer, small cell lung cancer, head and neck, esophageal, gastric, pancreatic, anal, hepatic, biliary, colorectal, cervical, endometrial, vaginal, vulvar, ovarian cancer and any other gastrointestinal or gynecological cancers requiring definitive radiotherapy alone with or without concurrent chemotherapy.
* Able to provide written informed consent and comply with all study procedures.
* Entire course of radiotherapy will be delivered at the University of Pennsylvania Perelman Center for Advanced Medicine.

Exclusion Criteria:

- Pregnancy or women of childbearing potential and men who are sexually active and not willing/able to use medically acceptable forms of contraception; this exclusion is necessary because the treatment involved in this study may be significantly teratogenic.
Determinants of Repeated Spontaneous Miscarriages and Unexplained Fetal Deaths

The DEFI-1 study recruited 625 women witnesses and 299 of their spouses. With regard to case couples, 271 cases were recruited from the spontaneous repeated miscarriages (SRM) subgroup (≥3 spontaneous miscarriage (SM) from trimester 1 of pregnancy) and 93 from the unexplained fetal death in utero (FDIU) subgroup from trimesters 2 and 3 of pregnancy.

The main objective of the DEFI 2 study is to increase the number of case-pairs in these 2 particular subgroups to replicate the results of the genetic determinants highlighted from cases and controls with extreme phenotypes and obtain a sufficient number of women with FDIUs to identify specific determinants.

The spontaneous repeated miscarriages (SRM) affect one to two fertile couples on 100, a fetal death in utero (FDIU) complicates the evolution of a pregnancy on 200. The SRM remain unexplained in 50% of the cases although a beam indirect arguments sometimes encourage to evoke a prothrombotic process and / or endothelial dysfunction, immunological disorders, an alteration of the ovarian reserve, and possibly the impact of genetic determinants. Regarding SRM, in the absence of a fetal, funicular cause or obvious preeclampsia, very diverse mechanisms are evoked depending on the placental histology (vasculoplacental, inflammatory, intervillitis, immunological, etc.). Thus, while these mechanisms remain for some to be demonstrated and are probably not unequivocal, clinicians are faced with a pressing request for therapeutic intervention on the part of patients. This is why, after having studied in DEFI-1 the 2 main constitutional thrombophilia in the 2 members of the couple, the procoagulant circulating microparticles and the generation of thrombin in the mother on the one hand, the modalities of inactivation of an X in the mother, on the other hand, a further investigation in subgroups of particular cases would be appropriate.

Eligibility Criteria:
Inclusion Criteria:

* couples whose wife is over 18 and under 40 inclusive,
* couples having undergone at least 3 unexplained SM in the first trimester or an FDIU in the trimesters 2 and 3 of pregnancy (excluding funicular and fetal causes and proven preeclampsia)
* the man must be over 18 years old.
* each member of the couple must consent to the investigation.
* Subjects benefiting from a social security scheme.

Exclusion Criteria:

* couples where the woman is under 18 or over 40,
* couples whose man is under 18,
* identified cause of SRM or FDIU
* Inability to consent for one of the members of the couple,
* refusal to participate for one of the members of the couple.
* treatment with anticoagulants or anti-aggregating platelet for women.
* Person under legal protection
* Subjects not benefiting from a social security scheme
* Refusal to participate
Trial of Non Invasive Ventilation for Respiratoy Distress Syndrome

The purpose of this study is to evaluate the hypothesis that nasal intermittent positive pressure(NIPP), used as a primary mode of ventilation in preterm infants with RDS, will decrease the need for conventional endotracheal ventilation when compared to nasal continuous positive airway pressure.(NCPAP)

Respiratory distress syndrome(RDS) and its sequelae, bronchopulmonary dysplasia(BPD) are complications of prematurity.The pathogenesis of BPD is multifactorial and one of the most important risk factors is the ventilator-induced lung injury caused by invasive respiratory support.

The two modes of non-invasive ventilation, NIPP and specially NCPAP, have been used frequently in the respiratory care of preterm infants in neonatal units.NCPAP is currently a common practice for the treatment of RDS . NIPP has been found to be more effective than NCPAP in apnea of prematurity and immediately after extubation in preterm infants,decreasing the need of endotracheal ventilation.

Alternative techniques of non-invasive ventilation has been suggested in some studies to decrease respiratory morbidities associated with prematurity.This non-invasive approach could be used initially as a primary mode of ventilation for infants with RDS in a effort to decrease lung injury and BPD.Studies are needed to compare the effectiveness of these therapies.

Eligibility Criteria:
Inclusion Criteria:

* preterm infants with RDS
* assigned to non invasive ventilation

Exclusion Criteria:

* preterm on endotracheal ventilation
* severe congenital pulmonary or cardiovascular malformation
Bonipar for Acute and Chronic Musculoskeletal Pain

This study is a non-inferiority study comparing efficacy and onset of action between the herbal extracts topical solution, Bonipar, and diclofenac sodium topical solution, diclofenac topical solution 1.5%.

This study is a non-inferiority study comparing efficacy and onset of action between the herbal extracts topical solution, Bonipar, and diclofenac sodium topical solution, diclofenac topical solution 1.5% (approved by the FDA as a topical analgesic). Approximately 168 Duke patients will be recruited from Duke Pain Clinic, and selected Duke primary care practices. Individuals who report acute (less than 3 months duration) or chronic musculoskeletal pain of any intensity will be considered for enrollment into the study. After obtaining consent, eligible subjects will be will be randomized to receive Bonipar or diclofenac topical solution 1.5%.

Eligibility Criteria:
INCLUSIONARY CRITERIA:

* Subject with acute and chronic localized musculoskeletal pain
* Ages 18 to 80 years
* Subjects of all races, gender or ethnic groups
* Female subjects of childbearing age must have a negative pregnancy test Female subjects of childbearing age who are sexually active must agree to use appropriate contraceptive measures for the duration of the study. Medically acceptable contraceptives include: (1) surgical sterilization (such as tubal ligation or hysterectomy), (2) approved hormonal contraceptives (such as birth control pills, patches, implants or injections), (3) barrier methods (such as a condom or diaphragm) used with a spermicide, or (4) an intrauterine device (IUD).
* Willing to provide written informed consent
* Patients taking opioid or NSAID for their musculoskeletal pain may be included if pain is inadequately controlled

EXCLUSIONARY CRITERIA:

* Patients meeting any of the following criteria will be excluded from the study: Use within 3 days of any topical agents on the affected area
* Subject with active skin lesions or skin disease or with cutaneous manifestations of systemic illnesses
* Subject with history of uncontrolled diabetes (A1C of more than 9)
* Subject with history of uncontrolled hypertension (SBP \> 160 and DBP \> 95)
* Subject with active uncontrolled GERD (defined as more than 2 episodes per week) or history of peptic ulcer disease
* Subject with active cancer, spinal cord lesions or spine surgery
* Subject with allergies to diclofenac or to other non-steroid anti-inflammatory drugs (NSAID)
* Known allergies to any oils, methyl salicylate and/or camphor
* Subject is pregnant or lactating
* Subject with history of heart attack, stroke or blood clot, or recent coronary artery bypass graft surgery (CABG) (i.e., within the last six months)
* Subject with history of alcohol or drug abuse within 1 year
* Subject with history of severe cardiac, liver or kidney disease or any other medical condition that may interfere with the subject's ability to participate in the study as determined by the Investigator
Multi-strain Probiotics to Prevent Necrotizing Enterocolitis in Very Preterm Infants

The goal of this clinical trial is to evaluate whether multi-strain probiotics of lactobacillus and bifidobacterium can prevent necrotizing enterocolitis (NEC) in preterm infants born at less than 32 weeks of gestation. The main questions it aims to answer are:

* Does the use of a multi-strain probiotic combination reduce the incidence of NEC in preterm infants?
* Are there any adverse effects associated with the administration of this probiotic combination?

Researchers will compare outcomes between two phases:

Control Phase: No probiotics will be administered, and outcomes will be recorded to establish baseline NEC rates.

Intervention Phase: Participants will receive a daily multi-strain probiotic combination (0.5 g sachet) starting within 24 hours of enteral feeding initiation.

Participants will be:

* Preterm infants born at \<32 weeks' gestation and \<1500 g birth weight.

The study uses a stepped-wedge cluster randomized trial (SW-CRT) design, where neonatal intensive care units (NICUs) transition from the control phase to the intervention phase at pre-specified intervals. Individual consent will be obtained for probiotic administration and data collection during the intervention phase, and data collection-only consent will be sought during the control phase.

This trial is designed to provide high-quality evidence on the efficacy and safety of probiotics in preventing NEC in preterm infants.

Eligibility Criteria:
Inclusion Criteria:

* Infants born between \<32 0/7 weeks gestation.

Exclusion Criteria:

* Major congenital or chromosomal abnormalities
* Conditions affecting gastrointestinal systems that prohibit infants from starting on feed in the first 72 hours after birth.
Determination of ALDH1b1 and ALDH2 Polymorphisms Frequency in the Brazilian Population

A case-control study with oral squamous cell carcinoma (OSCC) patients from Instituto do Câncer do Estado de São Paulo (ICESP) and healthy volunteers. In this study, it will be collected saliva samples from both groups that will be submitted to sequencing analysis to evaluate the frequency of ALDH1b1 and ALDH2 polymorphisms in the Brazilian population. Also, correlate OSCC risk to alcohol consumption or smoke, by applied questionnaires.

According to the World Health Organization (WHO), in 2016 there were 3 million deaths worldwide from alcohol abuse. ALDH1b1 and ALDH2 proteins are involved in the alcohol metabolism promoting the conversion of acetaldehyde to acetate. The genes that encode these proteins have genetic variants, also called polymorphisms, that can promote changes in their functions such as the accumulation of acetaldehyde in the body, resulting in facial flushing, tachycardia and headache. Studies reported the correlation between alcohol consumption and/or smoking and these polymorphisms to a higher risk for head and neck cancer, including oral squamous cell carcinoma (OSCC). The aim of this study is to determine the frequency of the ALDH1b1 and ALDH2 polymorphisms in the Brazilian population, in addition to estimating the risk for OSCC among those with polymorphisms. For this, unstimulated saliva samples will be collected from OSCC patients and healthy volunteers. All study participants must complete two questionnaires on alcohol consumption, smoking and disease history. Saliva samples will be collected using the DNA/RNA Shield Saliva Collection Kit and stored at -20ºC. The DNA will be extracted, quantified by the Nanodrop equipment and amplified by the polymerase chain reaction (PCR), using specific primers for each of the genetic variants. The PCR product will be sent to the Sequencing Service of the Centro de Pesquisas sobre o Genoma Humano e Células-Tronco/IBUSP, where the Sanger sequencing technique will be performed and the results will be analyzed in the ICB-USP laboratory. For the group of patients, medical records will be monitored to correlate clinical data and genetic variants with overall survival. These data will allow the characterization of the genetic variants of ALDH1b1 and ALDH2 in the Brazilian population and support the development of future public policies to reduce the main risk factors for OSCC, especially among those with these genetic variants.

Eligibility Criteria:
Inclusion Criteria:

* OSCC diagnostic for case group
* Able to read and sign the consent form.
* Able for saliva collection.
* Able to understand the applied questionnaires.

Exclusion Criteria:

* Unable to read and sign the consent form.
* Unable for saliva collection.
* Unable to understand the applied questionnaires.
* OSCC patient's companions for healthy volunteers.
Efficacy and Safety Study of MP-435 in Combination With Methotrexate (MTX) in Patients With Rheumatoid Arthritis

The purpose of this study is to determine the Efficacy, Safety, and Pharmacokinetics of MP-435 administered for 12 weeks in subjects with rheumatoid arthritis (RA) on stable doses of Methotrexate.


Eligibility Criteria:
Inclusion Criteria:

* Subjects with a diagnosis of RA according to the diagnostic criteria of the American College of Rheumatology (ACR) (revised in 1987) for at least 6 months.
* Subjects who inadequately response for stable dose of MTX.

Exclusion Criteria:

* Patients with Class IV functional activity by the Steinbrocker's scale.
* Patients who have received a biological agent in the past.
* Patients who have other rheumatic diseases, or who have other diseases with joint symptoms.
* Patients with severe or uncontrolled endocrine, psychiatric, cardiac, hematological, pulmonary, hepatic, kidney, gastrointestinal, or thyroid disease.
Intravenous Lidocaine Plus Intratracheal Dexmedetomidine on Postoperative Sore Throat

Objective: The present study was to investigate the effect of intravenous lidocaine combined with intratracheal dexmedetomidine on postoperative sore throat in patients undergoing thyroid cancer surgery.

Methods: Investigators enrolled 144 patients with American Society of Anesthesiologists (ASA) physical status I and II, aged 18-65 years, and scheduled for elective undergoing thyroid cancer surgery with general anesthesia. The participants were randomly assigned into four groups(n=36 each group): Group L received lidocaine 1.5 mg/kg was injected intravenously 3 min before endotracheal intubation and tracheal spray with 0.8% ropivacaine 40 mg (5 mL) for surface anesthesia. Group D received equal volume normal saline was injected intravenously 3 min before tracheal intubation and tracheal spray with dexmedetomidine (1 μg/kg) mixed with 0.8% ropivacaine 40 mg (5 mL). Group LD received lidocaine 1.5 mg/kg was injected intravenously 3 min before endotracheal intubation and tracheal spray with dexmedetomidine (1 μg/kg) mixed with 0.8% ropivacaine 40 mg (5 mL). Group C received equal volume normal saline was injected intravenously 3 min before tracheal intubation and tracheal spray with 0.8% ropivacaine 40 mg (5 mL) for surface anesthesia.The incidence and severity of postoperative sore throat were recorded in four groups at 1 h, 2 h, 6 h, 24 h and 48 h after operation.


Eligibility Criteria:
Inclusion Criteria:

* Thyroid cancer surgery with ASA grades I-II
* Aged 18-65 years
* The patient's communication is normal and they have a certain learning ability

Exclusion Criteria:

* Severe respiratory and circulatory system diseases
* There was bradycardia (HR \< 60 beats/minute) or atrioventricular block before the operation
* Nervous system disease
* Mental and psychological disorders
* Abnormal liver and kidney functions
* Pregnant and lactating women
A Double-blind, Placebo Controlled Trial of Risperidone for the Treatment of Anorexia Nervosa

The aim of this pilot study is to determine the safety and efficacy of risperidone for the treatment of anorexia nervosa.

Hypothesis 1: Subjects on risperidone will show a more significant decrease in body image distortion and Eating Disorder Inventory -2 scores than subjects on placebo.

Hypothesis 2: Subjects on risperidone will reach and maintain at or above 90% Ideal body weight sooner than controls.

The lack of effective medications for the symptoms of anorexia nervosa (AN), combined with early promising findings in case reports (Risperidone and Olanzapine) and one open study of olanzapine have led to increased use of these medications for individuals with AN. This double-blind placebo controlled study of risperidone will attempt to determine if risperidone is effective in decreasing core symptoms of anorexia nervosa and decreasing the length of time required to reach and maintain at or about 90% Ideal body weight. The safety of risperidone in this population will also be examined through monitoring of Extrapyramidal Symptoms, Tardive Dyskinesia, Electrocardiograms's, Resting Energy Expenditure, liver enzymes and other blood chemistry. Other possible variables which may mediate the recovery process or be impacted by risperidone,such as leptin and anxiety symptoms are also being measured.

Eligibility Criteria:
Inclusion Criteria:

* Primary Diagnosis of Anorexia Nervosa
* Female, age 12-21
* Active in a level of care for AN at The Children's Hospital, Denver
* As long as there is a primary dx of AN, co-morbid diagnoses may be included.
* If taking an antidepressant, must be on a stable dose for 3 weeks prior to entering the study, and dose of antidepressant may not be changed during Phase 1 of the study.
* If choosing to discontinue antidepressant medication, must be off the medication for 3 weeks prior to beginning the study.
* If sexually active, must use birth control during the study and have a monthly pregnancy test.

Exclusion Criteria:

* Previous enrollment in this study on a prior admission
* Previous allergic reaction to risperidone or other atypical neuroleptic
* Positive pregnancy test
* Neurologic disorder other than benign essential tremor
* Taking a psychotropic medication other than antidepressant and discontinuing the medication is not recommended.
* Active hepatic or renal disease
* Wards of the state
* Males
Blood Sugar Level and Postoperative Agitations in Pediatric Surgery

The aim of this study is to investigate the effect of fasting time and blood glucose levels on postoperative agitations in pediatric patients who will undergo outpatient surgery.

Emergence delirium is a very important clinic phenomenon, characterized by irritability and severe restlessness in children recovering from anesthesia; it may cause injury to the child recovering from anesthesia or to surgical site and may also lead to parents, who witness emergence delirium to question the quality of anesthesia. Postoperative agitaitons, has been noted with the newer, less soluble inhaled agents and emergence delirium has become a serious problem, taken care in postanesthesia care unit for anesthesiologists. Preoperative anxiety, premedication, anesthetic drugs, pain, type of surgery and emergence in a foreign environment are the factors which take part in the development of emergence delirium. Emotional and less social children, the children with anxious parents, children undergoing upper airway surgery are under risk. Detection of children at risk, the use of appropriate adjuvant drugs, strict control of postoperative pain, and accompanying parents to their children in the recovery room are currently the primary measures to prevent recovery agitation. Further studies are required to discover underlying causes and management of emergence delirium.

In this study pre-and postoperative blood glucose values, preoperative fasting times and hemodynamic values of 200 American Society of Anesthesiologists (ASA) physical status I-2 patients will be recorded. At the end of the operation, patients will be evaluated with Modified Aldrete Sedation Scale, FLACC Pain Rating Scale and PAED Agitation Scale. The results obtained will be evaluated with statistical methods and the relationship between preoperative fasting time and blood glucose levels and postoperative agitations will be investigated.

Eligibility Criteria:
Inclusion Criteria:

* Pediatric patients between 2-12 years of age who will undergo outpatient surgery

Exclusion Criteria:

* ASA III-IV patients, patients with congenital malformation and developmental delays, or any neurological or cardiac diseases
New Needle for Two-Needle Hemodialysis

Our preliminary studies have demonstrated that an innovative new design of the hemodialysis venous needle (the needle that returns the cleaned blood from the hemodialysis filter to the patient) with three jets is superior to the standard venous needle because it decreases the velocity and turbulence of the blood when compared with the standard venous needle, it is more efficient in the removal of toxins from the blood, and it is safe and effective. More importantly, our preliminary studies suggested that the new needle causes less damage to the dialysis vascular access and to circulating blood cells and less inflammation and oxidative stress. These will decrease medical complications, the high cost of care and death in dialysis patients. The current study will corroborate the finding of previous studies.


Eligibility Criteria:
Inclusion Criteria:(1) end stage renal disease receiving hemodialysis in an ambulatory outpatient dialysis facility (2) male or female, (3) ages 18-80, (4) arterio-venous graft or AV fistula as vascular access,

Exclusion Criteria:patients with fever, infection, inflammation or malignancy will be excluded