cyrilzakka/clinical-trials huggingface dataset:
Efficacy of Non-Invasive Mechanical Ventilation in Early Hypoxia Secondary to Thoracic Trauma

* Severe post-traumatic hypoxia is mainly due to lung contusion. The intubation rate of these patients is near 20%.
* Treatment before intubation is needed, is based on pain control with epidural anesthesia and oxygen.
* The investigators' hypothesis is that adding non-invasive mechanical ventilation to the standard treatment can reduce the intubation rate if applied early in the course of the disease.
* As thoracic trauma is often associated with injuries in other body regions that may increase the complications of the technique, specific contraindications have been described.


Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years.
* Informed consent obtained.
* pO2/FiO2 \<200 for more than 8 consecutive hours in the first 48 hours after thoracic trauma.

Exclusion Criteria:

* Orotracheal intubation indicated for any other reason.
* Standard contraindication for non-invasive ventilation (active gastro-intestinal haemorrhage, low level of consciousness, multiorgan failure, airway control problems, lack of cooperation, hemodynamic instability).
* Severe traumatic brain injury.
* Facial trauma with pneumocephalus, skull base fracture, orbit base fracture, any facial fracture involving a sinus.
* Cervical injury with specific treatment contraindicating a facial mask.
* Bronco-pleural fistula.
* Gastro-intestinal trauma.
Targeting Self-regulatory Deficits Through Cognitive Remediation Intervention

We are proposing a small randomized clinical trial in which 100 substance users will complete the existing Psychotherapy Development Center (PDC) pretreatment assessment battery as well as a novel battery of assays to evaluate cognitive-affective functioning. After completing pretreatment assessments, participants will be randomized to either a (1) cognitive remediation program (training tasks) specifically designed to address cognitive-affective dysregulation or (2) control tasks (verbal fluency tasks). Tasks will be completed twice per week for 4 weeks, after which assessment batteries will be repeated. Finally, we will evaluate real-world behavior and the durability of the training via a one-month follow-up, which will include assessment of substance use as well as the cognitive-affective battery.

Participants will be 100 individuals (aged 18 to 50) enrolled in outpatient (non- methadone/buprenorphine) treatment for any substance use disorder (other than PCP) at the Substance Abuse Treatment Unit in New Haven. As the goal of this project is to develop interventions that address self-regulation across multiple disorders, we will recruit individuals who have a range of substance use disorders and levels of severity. Our primary Specific Aim will be to evaluate the efficacy of the cognitive-remediation program relative to the control condition control on the indicators of cognitive-affective functioning and substance use, testing the hypothesis that individuals randomized to the cognitive remediation program will demonstrate improved functioning on the cognitive-affective battery as well as reduced real-world substance abuse. We will also explore potential moderators of response to the training, including baseline measures of cognitive-affective function.

Eligibility Criteria:
Inclusion Criteria:

* Meet current DSM-5 criteria for an alcohol, stimulant, cannabis, or opioid use disorder.
* Are sufficiently stable for 4 weeks of outpatient treatment.
* Are willing to provide locator information.
* Are fluent in English and have a 4th grader or higher reading level

Exclusion Criteria:

* Meet DSM-5 criteria for a bipolar or schizophrenic disorder.
* Who have a legal case pending such that incarceration during the 4-week protocol is likely.
* Are physically dependent on alcohol, opioids or benzodiazepines or who report recent PCP use.
* Have a baseline Shipley estimated IQ less than 70
* Have 3 or more head injuries with loss of consciousness for over 30 minutes or lasting effects
* Have a history of chronic illness or neurological disorders (e.g., epilepsy or stroke) that would complicate evaluation of effects of cognitive training
Hyaluronic Acid Evaluation as Adjuvant to Temporomandibular Joint Arthroscopy

This study evaluates the addition of hyaluronic acid to temporomandibular joint arthroscopy in the treatment of internal derangements in adults. A participants group will receive temporomandibular joint arthroscopy plus hyaluronic acid, while the other group will receive temporomandibular joint arthroscopy. Hypothesis: hyaluronic acid as an adjunct in temporomandibular joint arthroscopic surgery provides additional benefits in clinical and radiological outcomes in temporomandibular joint internal derangements.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of temporomandibular joint internal derangements in Wilkes stages III and IV by magnetic resonance imaging
* Limitation of maximum oral opening or duplication of joint pain by palpation
* lack of response to conservative therapies

Exclusion Criteria:

* Any degenerative systemic disease of muscular or joint involvement (rheumatoid arthritis, etc.)
* Previous temporomandibular joint surgical treatment: arthrocentesis, arthroscopy or open surgery
* Infection in Temporomandibular Joint or in puncture site
* Hyaluronic acid or corticosteroids injection in Temporomandibular Joint in previous 6 months
* Pregnant or breastfeeding women
* Participants who refuse to complete the treatment or unavailable to complete the follow-up
Predictive Clinical and Biological Parameters in Breast Cancer

Research of predictive clinical and biological factors in breast cancer :

genomic, proteomic, mutation


Eligibility Criteria:
Inclusion Criteria:

* breast cancer
* age \> 18
* signed informed consent

Exclusion Criteria:

* emergency
Evaluation of the Efficacy of the AIM (Adult Identity Mentoring) 4 Teen Moms Program

The purpose of this study is to evaluate the efficacy of the AIM 4 Teen Moms program in increasing the use of long-term contraceptives, in improving adherence to contraceptives and in preventing rapid repeat pregnancies among parenting adolescents.

This study uses a randomized controlled design to evaluate the efficacy of AIM (Adult Identity Mentoring) 4 Teen Moms in reducing the incidence of rapid repeat pregnancies and associated sexual risk behavior. The AIM 4 Teen Moms program is a combination of individual and small group sessions intervention that encourages parenting young women ages 15-19 years old to delay rapid repeat pregnancies for 24 months or later. It consists of seven individual 1-hour long sessions (generally conducted in the participant's home) and two 90-minute group sessions delivered over a 12 week period. Study participants will be adolescent mothers receiving services from California's Adolescent Family Life or Cal-Learn programs in the Los Angeles County area. There will be no intervention delivered to members of the control group. This study is being conducted as part of the national Evaluation of Adolescent Pregnancy Prevention Approaches funded by the U.S. Department of Health and Human Services' Office of Adolescent Health.

Eligibility Criteria:
Inclusion Criteria:

* Beneficiaries of California's Adolescent Family Life or Cal-Learn programs in the Los Angeles County area
* Female
* 15 - 19 years old
* Has a child between the ages 1 and 6 months at program start
* English or Spanish speaker
Treatment Patterns With Targeted Therapies In Mrcc In Sweden - A Retrospective Analysis Of Data From National Registries

The objectives of this study is to investigate treatment patterns and outcomes for Sutent and Inlyta in mRCC patients in a nationwide population-based setting in Sweden.


Eligibility Criteria:
Inclusion Criteria:

1. all patients aged ≥ 18 years with at least one filled prescription of an oral targeted therapy relevant for treating mRCC registered in the Swedish Prescribed Drug Register (PDR) between July 1st 2005 and June 30th 2020. The Anatomical Therapeutic Chemical (ATC) codes for the oral drugs relevant for treating mRCC are the following: L01XE04 (sunitinib), L01XE05 (sorafenib), L01XE11 (pazopanib), L01XE17 (axitinib), L01XE10 (everolimus), L01XE26 (cabozantinib), L01XE34 (tivozantib), L01XE29 (lenvatinib).
2. The patients identified in the PDR that also are identified in the SCR with the International Classification of Diseases and Related Health Problems (ICD)-7 diagnosis codes I800 or I809 and ICD-10 codes C64.0 and C64.9 from January 1st 2000 until December 31st 2019;excluding ICD-7 code I801 (cancer of the renal pelvis) will be included in the analysis set.

Exclusion Criteria:

Patients with ICD-7 code I801 will be excluded
Phase Ib Study to Evaluate PRS-080 in Anemic Chronic Kidney Disease Patients

Anticalins® are engineered human proteins that are able to bind specific target molecules. The Anticalin PRS-080#022-DP to be investigated in this study is directed against hepcidin and is intended for the treatment of anemia of chronic disease. This Phase Ib study shall investigate the safety, pharmacokinetics and pharmacodynamics of a single administration of PRS-080#022-DP in anemic stage 5 chronic kidney disease patients undergoing hemodialysis.

This is a multi-center, randomized, double-blind, placebo-controlled, single ascending dose phase Ib study in anemic stage 5 chronic kidney disease patients requiring hemodialysis. Eligible subjects will undergo screening assessments and PRS-080#22-DP will be administered by intravenous infusion. The study will consist of 3 dose cohorts of 2 mg/kg, 4 mg/kg, and 8 mg/kg body weight with 8 subjects in each cohort. Using a standard 6+2 design, 6 subjects in each cohort will be randomized to PRS-080#022-DP and 2 subjects in each cohort will be randomized to placebo. The decision to escalate the dose will be based on an interim analysis of clinical safety and safety laboratory data. Safety and tolerability, pharmacokinetics, pharmacodynamics as well as potential immunogenicity will be investigated.

Eligibility Criteria:
Inclusion Criteria:

* Patients with stage 5 chronic kidney disease having been on hemodialysis for at least 90 days
* Patients being on stable erythropoiesis-stimulating agent (ESA) dose
* Hemoglobin (Hb) 9 - 11 g/dL
* Ferritin ≥ 300 ng/mL.
* Transferrin saturation (TSAT) ≤ 30%
* Hepcidin 5 - 50 nmol/L

Exclusion Criteria:

* Anemia due to causes other than chronic kidney disease, including hemoglobinopathies, hemolytic anemias, myelodysplasia or malignancy
* Blood transfusion within 2 months before administration of study medication.
* Iron treatment from 1 week before study medication administration until 1 week after study medication administration.
* Previous enrollment in this study
* Current or previous (within 60 days before study medication administration) treatment with another investigational drug and/or medical device or participation in another clinical study.
* Pregnancy or breast-feeding women of child bearing age.
* Known allergy to any component of the PRS-080#022-DP formulation
* Positive for hepatitis B surface antigen, anti-hepatitis C virus antibody, or human immunodeficiency virus
* Planned surgery during the study period
* Unwilling or unable to comply with the protocol, in the judgment of the investigator
* Unstable angina, myocardial infarction, percutaneous transluminal coronary angioplasty/stents, apoplexy or coronary artery bypass grafting \<3 months prior screening.
* Congestive heart failure: New York Heart Association Class III or IV.
Labor Characteristics and Outcomes in Women With Gestational Hypertension or Preeclampsia Who Underwent Labor Induction

Comparison of Labor Characteristics and Maternal-Neonatal Outcomes in Induced Labor Between Women with Gestational Hypertension/Mild Preeclampsia and Normotensive Controls

The American College of Obstetricians and Gynecologists (ACOG) recommends that women with gestational hypertension or preeclampsia without severe features at or beyond 37 weeks of gestation are usually managed by scheduled induction of labor (IOL). Occasionally, normal pregnant women request elective induction of labor because of a perceived decrease in fetal movements in the presence of normal findings in fetal heart rate monitoring. However, there is limited information available to compare labor induction outcomes between patients with gestational hypertension or mild-preeclampsia and those with normal pregnancies. In addition, no studies have analyzed the characteristics and interventions of labor in hypertensive patients with induction of labor who undergone vaginal birth. Therefore, the purpose of this project was to investigate the differences of labor characteristics and maternal-neonatal outcomes with induction of labour (IOL) between pregnant women with gestational hypertension or mild pre-eclampsia and those with normotensive pregnancies, providing clinical references of intrapartum management for women with gestational hypertension or mild pre-eclampsia.

Our results showed that women with hypertensive pregnancies had higher rates of cesarean delivery due to failed induction compared to normotensive pregnancies. However, no significant differences were observed in induced labor characteristics, intrapartum interventions, and maternal-neonatal complications between women with gestational hypertension or mild pre-eclampsia and those with normotensive pregnancies. Parity, bishop score, birth weight, and the hypertensive disorders of pregnancy were independently and significantly associated with an increased risk of cesarean section following induction. Consequently, these findings could provide evidence for the intrapartum management of labor induction in women with gestational hypertension or mild pre-eclampsia.

Eligibility Criteria:
Inclusion Criteria:

* Undergoing an induction of labor at term (37-42 weeks) who gave birth to a live born, non-anomalous singleton in cephalic presentation, as well as women aged 18-35 years old

Exclusion Criteria:

* Women with pregnancy complications including diabetes mellitus, intrahe-patic cholestasis of pregnancy, placenta previa, placental abruption, oligohydramnios, and polyhydramnios, previous caesarean births, fetal birth weight of ≥4.0 kg, severe preeclampsia, chronic hypertension, prepregnancy hypothyroidism and hyperthyroidism, renal system disease, nutritional deficiency, immune system disease, hematological system diseases, and prepregnancy thrombocytopenia. Women were also excluded if clinical data were incomplete.
IL-6 Regulation of Energy Stores During Recovery From an Acute Exercise Bout

The aim of the study is to investigate the role of exercise-induced IL-6 in regulating energy stores and energy metabolism during recovery after an acute exercise bout. To achieve this, 30 men will be randomized to infusion placebo or tocilizumab (IL-6 receptor antibody) combined with a 2-hour exercise bout. Stable isotope tracers will be infused to determine substrate kinetics. Indirect calorimetry will be applied to determine substrate oxidation, and muscle biopsies will be taken to determine substrate uptake and storage.


Eligibility Criteria:
Inclusion Criteria:

* Physically active (defined as meeting the ACSM's guidelines of 2.5h per week of moderate to vigorous physical activity per week), young, healthy males will be included. Participants may be included in the study if they meet all the following criteria:

  * Age ≥ 18 years and ≤ 40 years
  * BMI \< 18 and \> 25 kg/m2
  * Healthy (based on screening)
  * Stable body weight for 6 months
  * ≥ 2.5h/week moderate to vigorous physical activity

Exclusion Criteria:

* • Cardiovascular disease

  * Rheumatologic disease
  * Metabolic disease
  * Elite sports or high aerobic training status (VO2max \> 60 mL O2/min/kg)
  * Frequent/chronic use of medications affecting physical performance or inflammation (NSAIDS, DMARDS, corticosteroids)
  * Aspirin use \>100 mg/d
  * Thyroid disease
  * Current infection
  * Aspartate amino transferase (AST) or alanine amino transferase (ALT) \>2x upper normal range
  * History of carcinoma
  * History of tuberculosis
  * Ketogenic diet
  * Smoking
  * Anemia (hematocrit \<33%)
  * Neutrophil count \<0,5x 109/l
  * Thrombocytes \<50x 109/l or bleeding disorders
Liver Enzymes and Metabolic Risk Factors Response to Laser Acupuncture Versus Cupping Therapy in Fatty Liver

fatty liver disease is characterized by low antioxidants, disturbed lipid metabolism, cardioautonomic functions, and elevated blood measures (glucose, inflammatory markers, liver enzymes)

In fatty liver patients,applied cupping (with scarification) will be compared, regarding its effect on antioxidant, lipid metabolism, cardioautonomic functions, and blood measures (glucose, inflammatory markers, liver enzymes), to application of laser on acupoints

Eligibility Criteria:
Inclusion Criteria:

* fatty liver obese patients

Exclusion Criteria:

thoracic diseases heart diseases kidney diseases
Investigation of the Effects of Balance Discs With Different Surfaces Used in Balance Education in Children With Cerebral Palsy on Proprioceptive Sense and Balance.

This is a non-invasive prospective study investigating the effects of balance discs with different surfaces used in balance education in children with cerebral palsy on proprioceptive sense and balance.

Many methods are used for balance training. One of them is balance discs. Balance discs consist of smooth and rough surfaces. Balance training is given to children with cerebral palsy on these two surfaces. Thanks to its balance disc structure, it plays an active role in the development of balance, but there is a need for evidence about whether rough or smooth surfaces and training have superiority over each other. Knowing the difference between the two surfaces will help the staff about which surface to use in the treatment and will be beneficial for the children.

The aim of this study is to determine whether there is a difference between a rough and smooth surface in terms of improving proprioceptive sense and balance.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with cerebral palsy
* Diagnosed with motor developmental delay
* 0-12 years old
* Levels 1 and 2 according to GMFCS
* Having bilateral and unilaterally affected spastic type CP
* Cooperate with assessments

Exclusion Criteria:

* Botulinum toxin administration in the last 6 months
* Having had any surgical operation in the last 6 months
* Having dyskinetic, ataxic and hypotonic type CP
* Unable to cooperate with assessments
Fetal Programming of Obesity

The overall goal of this project is to understand how a mother's health at conception may influence her child's growth and development.

The purpose of this study is to determine how the mother's health prior to or at the beginning of pregnancy may influence her child's growth and development. We plan to: 1) longitudinally and simultaneously assess a true measure of body composition (lean and fat mass) of the offspring, assess body composition of both parents, and obtain dietary intake data of the mother and offspring; 2) determine endocrine and metabolic profiles of the mother at baseline (pre-conception), during pregnancy and at birth (such as insulin, glucose, leptin); 3) determine the energy expenditure and physical activity of the mother and the child; 4) determine gene expression of the placenta and umbilical cord via gene microarray and real time PCR; and 5) focused on appropriate-for-gestational age (AGA) infants (the majority of infants born from normal and overweight mothers).Accordingly, this study will provide much needed comprehensive information on the possible effect of fetal programming on the development of pediatric obesity.

Eligibility Criteria:
Inclusion Criteria:

* healthy
* 21 years of age or older
* second pregnancy, singleton
* conceived without fertility treatments

Exclusion Criteria:

* Preexisting medical conditions
* Sexually transmitted diseases
* Medical complications during pregnancy
* Medications during pregnancy known to influence fetal growth
* Smoking, alcohol drinking
* Excessive physical activity level which could affect the outcome of interest.
Temsirolimus in Combination With Gemcitabine in Previously Untreated Metastatic Pancreatic Cancer

The purpose of this research study is to try to define the highest doses of temsirolimus and gemcitabine that can be used safely in combination to treat advanced pancreatic cancer. Gemcitabine is a standard chemotherapy used for the treatment of pancreatic cancer.

* Because this is a study to determine the highest doses of temsirolimus and gemcitabine that can be given safely together, groups of 3 subjects will be treated at gradually increasing doses of the drugs. Each group of 3 subjects must complete 4 weeks of treatment (1 cycle) before the following group of 3 subjects can start treatment at the higher dose of drug.
* Temsirolimus will be given intravenously every week of the 28 day treatment cycle (days 1, 8, 15, 22). Gemcitabine will be given intravenously every other week of the treatment cycle (days 1. 15).
* During the study, participants will have weekly clinic visits where the following tests and procedures may be performed: Physical exam; vital signs; urine test; blood tests.
* A CT scan will be performed after every 2 cycles (8 weeks) to assess teh response of the tumor to the study treatment.

Eligibility Criteria:
Inclusion Criteria:

* Previously untreated metastatic pancreatic adenocarcinoma, histologically proven.
* Measurable disease by RECIST criteria
* ECOG Performance Status 0 or 1
* Male or female, 18 years of age or older
* Life expectancy of \>/= 12 weeks
* AST and ALT \</= 2.5 x ULN
* Total bilirubin \</= 1.5 x ULN
* Serum albumin \>/= 2.5g/dL
* Absolute neutrophil count \>/= 1500/mm3; platelets \>/= 100,000/mm3; hemoglobin \>/= 9.0 g/dL
* Serum creatinine \</= 1.5 x ULN
* Subjects with diabetes must have adequate glycemic control, with fasting serum glucose \</= 1.5 x ULN
* Female patients of childbearing age and male patients with partners of childbearing age must agree to use adequate birth control measures during the course of the study and for at least one month following withdrawal from the study

Exclusion Criteria:

* Previously treatment with gemcitabine or chemoradiation
* Diagnosis of a second malignancy within the last 3 years, except for adequately treated basal cell carcinoma or squamous cell skin cancer
* Ongoing cardiac dysrhythmias of NCI CTCAE grade \>/= 2, atrial fibrillation, QTc prolongation to \> 450 msec for males and \>470 msec for females
* Known immunodeficiency disorders or active infections requiring treatment
* Pregnancy or breastfeeding
* Known brain metastases, spinal cord compression, carcinomatous meningitis, or leptomeningeal disease
* Prior radiation therapy or major surgery within 4 weeks of study entry
* Prior radiation therapy to \> 25% of the bone marrow
* Subjects receiving other experimental or alternative therapies during the course of the trial will be excluded
* History of prior hypersensitivity to polysorbate