cyrilzakka/clinical-trials huggingface dataset:
Neuropathic Pain After Lung Surgery

To understand pain pathophysiology in terms of risk factors and protective mechanisms ranging from molecular pathways to societal impacts.

Pain and loss of function are intimately associated with the reaction of the nervous system to neural damage. A lesion to the somatosensory nervous system caused by mechanical trauma, metabolic disease, neurotoxic chemicals, infection or tumor invasion may give rise to neuropathic pain. Neuropathic pain affects around 8% of the population and may negatively impact the individual's quality of life; moreover, the condition leads to significant costs to the healthcare system and society. Not all subjects with such a lesion develop neuropathic pain, and those who do develop neuropathic pain have varying degrees of symptom severity, impact and outcomes and may respond unpredictably to treatment.

The interaction between genetics and environmental and clinical factors in a susceptible individual most likely contribute to the variation in pain prevalence and severity. A better understanding of the exact nature of these risk factors and their interactions will ultimately improve the patients' health, both in terms of recognizing patients at risk and identifying new treatment modalities.

Genetic, neurophysiological and psychological factors all influence the risk of developing persistent pain. It is therefore possible to describe a genetic, neurophysiological and psychological profile, in particular in patients experiencing neuropathic pain after surgery and/or neurotoxic chemotherapy.

Eligibility Criteria:
Inclusion Criteria:

* Male and female subjects.
* Age ≥18 years.
* Patients scheduled for lung cancer resection performed via thoracoscopy and/or thoracotomy, including lobectomy, bilobectomy, pneumonectomy, resection of the tracheobronchial bifurcation, wedge resection, sleeve resection and combinations hereof.
* Willingness and ability to comply with study procedures as judged by the site investigator/manager.
* Expected availability for follow-up throughout the study, i.e., \~12 months.
* Willingness to voluntarily sign and date the study-specific informed consent form.

Exclusion Criteria:

* Mental incapacity or language barriers precluding adequate understanding of study procedures.
* Current alcohol or substance abuse according to the site investigator's medical judgement.
* Unsuitability for participation in the study for any other reason, e.g. due to a significant serious underlying condition (e.g. other cancer or AIDS), as determined by the site investigator/manager.
CIMR Neuromuscular Research Biobank

The purpose of this research repository is to collect, store, and share with other researchers any tissues that subjects with all types of neuromuscular disease are willing to donate. These samples will be stored at Virginia Commonwealth University (VCU) and will be used for future research with this population.

The study involves collection of medical information about research participants and their families. No identifying information about family members will be collected. Research participants will be asked for any general knowledge they have related to possible neurological disorders.

Research participants are also given the opportunity to provide blood, skin cells, urine, saliva, fecal matter, muscle tissue, cells, DNA and/or RNA samples.

Before any study procedures take place, the informed consent form will be provided and reviewed with potential research participants in detail. Potential research participants will have an opportunity to ask additional questions before starting any study procedures.

Eligibility Criteria:
Inclusion Criteria:

* Willing and able to give informed consent
* Positive diagnosis or suspected diagnosis of neuromuscular disease, or
* Family history of neuromuscular disease, or
* Healthy volunteer
* Age Neonates-75

Exclusion Criteria:

* Unwilling to sign consent
Effect of Kangaroo Baby Massage on Mother-infant Interaction at Home

The objective of this randomized clinical trial will determine the effectiveness of nursing intervention (Kangaroo Baby Massage) on the interaction between mothers and premature, low birth weight infants at home The dyad mother- infant of the control group will receive Kangaroo position KP and the dyad mother- infant mothers of the intervention group will receive the Kangaroo Baby Massage KBM

Participants and methods: 68 dyads mother-infant will randomize, 34 in intervention KBM group and 34 in control group KP, previous they meet inclusion criteria and accept their participation through informed consent. weight gain and Kangaroo position days at home will be the primaries outcomes. The Alert states, Types of BC feeding, Perceived maternal parental self-efficacy and Postnatal depression. Will be secondary outcomes.

Barnard's mother-child interaction theory supports the study

Eligibility Criteria:
Inclusion Criteria

* Prematures and low birth weight infants in Kangaroo position with a chronological age less than 3 months
* The mothers take care the infant at home
* Baby with a weight equal to or greater than 1800 grams at the time of entry to the study.
* Baby whose birth was institutional or extra-institutional.
* Mothers with training in the Kangaroo Mother Program
* Children controlled in the Ambulatory Kangaroo Mother Program

Exclusion Criteria

* Children diagnosed with intraventricular hemorrhages grade III and IV or congenital malformations
* Children who have more than one ambulatory kangaroo control
* Children who have been at home for more than 3 days without starting the ambulatory kangaroo control
* Babies with infections and other pathologies that require hospitalization during the study
* Presence of infectious diseases and other pathologies in the mother that require hospitalization
* Mother confirmed with positive test for covid 19 at the moment of the randomization
* Mothers with cognitive problems or mental disorders.
A Comparative Evaluation of TEG Versus ROTEM for Coagulopathy Correction

Studies comparing Thromboelastography or Rotational thromboelastometry versus standard coagulation tests are abundant. Data comparing the two exclusively in a liver intensive care set up is limited.

Studies show that TEG and ROTEM cannot be used interchangeably in trauma, liver transplant patients, but there is limited evidence of the same in critically ill cirrhotic patients.

In this study, the investigators tried to demonstrate the comparison of blood products used to treat coagulopathy based on TEG versus ROTEM algorithms in cirrhotic patients presenting with non variceal bleeding

Thromboelastography (TEG) and thromboelastometry( ROTEM) are point-of-care, global hemostasis assessment tests that measure the viscoelastic changes that occur during the hemostatic process.

Patients with cirrhosis have an imbalance of procoagulants and anticoagulants combined with alterations in fibrinolysis ,platelet number and function.

Point of care viscoelastic tests (TEG ,ROTEM) demonstrate specific functional coagulation defects that can direct blood component transfusion therapy in cirrhosis, with clinical validation of individual parameters.

Studies comparing Thromboelastography or Rotational thromboelastometry versus standard coagulation tests are abundant. Data comparing the two exclusively in a liver intensive care set up is limited.

Studies show that TEG and ROTEM cannot be used interchangeably in trauma, liver transplant patients, but there is limited evidence of the same in critically ill cirrhotic patients.

In this study, the investigators tried to demonstrate the comparison of blood products used to treat coagulopathy based on TEG versus ROTEM algorithms in cirrhotic patients presenting with non variceal bleeding

Eligibility Criteria:
Inclusion Criteria:

* patients of liver cirrhosis with non variceal bleed

Exclusion Criteria:

1. Pregnant and postpartum patients
2. died within the first 24hours of admission.
3. variceal and postvariceal ligation ulcer bleed.
4. On anticoagulants or antiplatelets at the time of admission in ICU
5. Transfusion with blood products before admission to the ICU.
Vessel Wall Enhancement in Giant Cell Arteritis

The research study is being conducted to determine the utility of magnetic resonance imaging (MRI) in identifying inflammation of arteries supplying blood to the head, brain, and eyes. The target population includes patient diagnosed with giant cell arteritis (GCA; temporal arteritis).

After signing the consent form, participants will complete an MRI scan within 2 weeks of enrollment and fill out questionnaires related to their disease. Follow up visits and MRI scans may occur at 1-month, 6-months, 12-months after the initial MRI scan or at the time of relapse.

Eligibility Criteria:
Inclusion Criteria:

* Participant must be in one of the following groups:

  1. Suspected new diagnosis of GCA
  2. Suspected relapse of GCA (new or worsening symptoms attributed to active GCA) in patient with previously established diagnosis of GCA
* The participant must have (or previously had) cranial manifestations related to or concerning for GCA including: visual symptoms, headache, temporal artery tenderness, jaw claudication, scalp tenderness, or stroke
* Participant must be within 14 days of initiating or escalating systemic glucocorticoids (e.g., prednisone) OR have ongoing cranial symptoms concerning for active disease at time of baseline MRI.
* Participants who are receiving a clinically-indicated MRI at the time of enrollment may participate even if they meet exclusion criteria of creatinine clearance less than 30 ml/min or mild gadolinium allergy
* Participants must sign the informed consent form

Exclusion Criteria:

* Contra-indication to receiving MRI including:

  * Implanted medical devices, pacemaker and metallic foreign fragments inside body or orbit
  * Known gadolinium allergy
  * Estimated glomerular filtration rate less than 30 ml/min/1.73m2
* Claustrophobia
* Women who are pregnant or nursing
Preventive Analgesia in Multiparas Undergoing Induction of Labour

Our study is about providing a better birthing experience by placing and initiating epidural for labour pain before the contractions start. This concept of prevention of pain before its onset is known as preventive - or preemptive -pain management and is well known in surgical and anaesthetic practice. We believe that the use of preventive epidural analgesia will improve the quality of labour epidurals, increase maternal satisfaction and reduce the stress response to labour and delivery.

Labour induces a well-documented stress response in both mother and fetus. Pain, anxiety and stress associated with labour result in the activation of the sympathetic nervous system, which increases plasma catecholamine concentrations with a resultant increase in cardiac output, peripheral vascular resistance and eventually, reduction in utero-placental perfusion. One aspect that has not been addressed in the literature is the role of preventive analgesia in labour. We believe that the use of preventive epidural analgesia will improve the quality of labour pain, increase maternal satisfaction and reduce the stress response in labour.

The multiparous parturients that are scheduled for elective inductions of labour will be offered preventive epidural analgesia. Upon placing the epidural, patients will receive, in a double blind fashion, one of two possible epidural drug regimens, which are a saline placebo or 0.0625% bupivacaine with 2 micrograms of fentanyl per millilitre. The patient then undergoes routine induction and management of labour. At any point after induction of labour, patients in either group can request analgesia. Upon request for analgesia the standard epidural loading dose and infusion with PCEA is initiated. The primary outcome will be the success of analgesia (Verbal Analogue Scale of 3 or less) during the first stage of labor, from first request of epidural analgesia to full dilatation.

Eligibility Criteria:
Inclusion Criteria:

* Multiparous patients who had previous vaginal delivery, undergoing induction of labour
* Singleton Pregnancy

Exclusion Criteria:

* Morbid Obesity
* Patients who have received cortisol, opioids or sedatives within the last 24 hours
Validity and Reliability of Commercially Available Metabolic Carts

The validity (by alcohol burning and gas infusions) and reliability (day-to-day variability in healthy subjects) of six metabolic carts will be compared.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male or female.
* Age 18-65 y.
* BMI between 18.5 kg/m2 and 40 kg/m2 (inclusive).
* Are willing to fast and not consume non-caloric stimulant for 10h before the assessments, and during the stay in the center.
* Are willing to avoid moderate or vigorous physical activity during 24h before the visits.

Exclusion Criteria:

* Smoking or use of tobacco products within the last 3 months
* Diagnosed with diabetes.
* Previous bariatric surgery (or other surgeries) for obesity or weight loss.
* Use of medications affecting metabolism or sleep.
* History of neurological disease.
* History of cardiovascular disease, including hypertension, or other chronic diseases.
* Pregnant, planning to become pregnant, or breastfeeding
* Claustrophobia impeding to stay calm under a plastic canopy.
Influence of Beer on Gut Microbiota and Biochemical Outcomes: Alcohol Impact.

Our aim is to assess the effects of moderate consumption of beer and non-alcoholic beer on gut microbiota and biochemical biomarkers in healthy adults.


Eligibility Criteria:
Inclusion Criteria:

* Adult men (18-65 years);
* Healthy volunteers free of chronic diseases with relevant effect on gastrointestinal system;
* Without a diagnosis of any digestive disease including functional bowel disorders such as IBS;
* Moderate alcohol consumers;
* Willing and able to provide written informed consent.

Exclusion Criteria:

* Documented cardiovascular disease (ischaemic heart disease - angina or recent or old myocardial infarction or previous or cerebral vascular accident, peripheral vascular disease);
* With diabetes or other relevant metabolic diseases;
* With any known infectious diseases, namely infections with HIV, Hepatitis B or C virus;
* Intake of antibiotics in the last 4 weeks and laxatives in the last 2 weeks;
* Subjects with history of drug, alcohol or other substances abuse.
Whey Permeate Study

This is a prospective, randomized, double-blinded, controlled clinical effectiveness trial of two supplementary foods in the treatment of MAM.

Specific Aim 1: Test the effectiveness of two supplementary foods, whey RUSF and soy RUSF, in the treatment of MAM in 6-59 month old children in a 12-week home-based supplementary feeding program.

Hypothesis: The proportion of children who recover receiving either soy or whey RUSF will differ by no more than three percent.

This will be a randomized, double-blinded, controlled clinical effectiveness trial assessing the treatment of moderate acute malnutrition (MAM) with one of two supplementary foods for a period of up to 12 weeks. The overall purpose of this research is to see if your child will grow and gain weight more rapidly using one of two peanut butter foods as he/she recovers from protein-energy malnutrition.

Subjects will be given a soy or dairy peanut butter food at their home. The peanut butter food has either small amounts of soya protein and minerals (iron, zinc) or whey powder and minerals added to them. Subjects will have enough food to feed the child for 2 weeks, and asked to return every 2 weeks to be weighed, measured and given more food. The parents of the subjects will be asked to feed their child this food until his/her weight has returned to what is considered normal for the child's height. Subjects will then return after 3, 6 and 12 months for a check-up. At these check-ups, he/she will be measured and examined.

The current standard of care is to allow the child to recover without food or with supplemental flour thus all participation is related to research. Participation in this study is expected to last 8-12 weeks of therapy with follow up in 12 months after completion of the therapy.

Eligibility Criteria:
Inclusion Criteria:

* Children with MAM defined as mid-upper-arm circumference, MUAC, ≤ 12.5 cm and \> 11.5 cm without bipedal edema.

Exclusion Criteria:

* Children simultaneously involved in another research trial or supplemental feeding program
* Children with developmentally delayed
* Children with a chronic debilitating illness such as cerebral palsy (not including HIV or TB)
* Children with a history of peanut or milk allergy
* Children will also be excluded if they had received therapy for acute malnutrition within one month prior to presentation.
Safety of Orectalip® (Oxaliplatin) as Adjuvant Treatment for High-risk Stage-Ⅱ Colorectal Cancer

Open- Label, Single Arm Study. To evaluate the safety profile of Orectalip® (oxaliplatin), fluorouracil and leucovorin as adjuvant therapy in the treatment of high-risk stage-Ⅱ colorectal cancer.

Primary end point:To evaluate the incidence of grade 0-3 neurosensory symptoms (paresthesia) in the end of study.

Other end points:The incidence of Grade 3 or 4 neutropenia, thrombocytopenia, anemia, nausea, diarrhea vomiting over the 12 weeks.

Safety will be evaluated including vital signs are recorded at all visits.

There were 18 out of 20 patients who completed the trial and eligible for statistical analysis, 2 patients withdraw because the wound infection. There were 11 (61%) male patients and 7 (39%) female patients. The patients aged from 30 to 73 years and their mean age was 50.4 years.

The grade of each adverse event evaluation mainly allocated in Grade 0 and Grade 1. The incidence of Grade 3 or 4 was only found for the following symptoms: leucopenia, neutropenia, and anemia. One (6%) adverse event of leucopenia occurred at visit 1 and visit 2, respectively. One (6%) adverse event of neutropenia occurs at visit 1, visit 2, and visit 3, respectively; while 2 (13%) events occurred at visit 5. One patients suffered adverse event of anemia at visit 5 and visit 6.

Eligibility Criteria:
Inclusion Criteria

1. Subject must have World Health Organization performance status score less than 1.
2. Subject must have WBC more than 4,000 cells, platelet count more than 100,000, absolute neutrophil count more than 1,500 serum bilirubin level less than1.5mg, serum creatinine level less than1.5mg

Exclusion Criteria

1. Subject who has received oxaliplatin treatment
2. Subject who has history of allergy to platinum derivates agents
3. Subject who has decompensated liver function(ALT、 AST and alkaline phosphatase more than 2.5 times of upper limit of normal range).
4. Subject has serious concomitant illness preceding the entry into the study.
5. Female subject who is pregnant or breast feeding.
6. Female subject who is going to be pregnant within 6 months during treatment.
Feto-Endoscopic Tracheal Occlusion (FETO) for Left Congenital Diaphragmatic Hernia

Tracheal occlusion IDE approved by FDA for congenital diaphragmatic hernia fetuses.

Fetuses with congenital diaphragmatic hernia with liver-up, and an observed to expected lung-to-head ratio of \<25%, LHR \<1, or a moderate category with o/e LHR \<30%, singleton pregnancy, no known other anomalies, gestational age \< 29 weeks 6 days (severe), gestational age \< 31 weeks 6 days (moderate), no maternal disease, maternal age \> 18 years old.... meet criteria to be offered fetal tracheal occlusion. We want to test feasibility and efficacy in our center.

Eligibility Criteria:
Inclusion Criteria:

* Isolated CDH with liver up
* Severe pulmonary hypoplasia with ultrasound O/E LHR \<25% at the time of surgery
* Gestational age at FETO procedure 27 weeks 0 days to 29 weeks 6 days
* Moderate pulmonary hypoplasia with ultrasound O/E LHR \<30% and liver-up at the time of surgery
* Gestational age at FETO procedure 30 weeks 0 days to 31 weeks 6 days in this moderate category
* Maternal age greater than or equal to 18 years
* Gestational age at enrollment prior to 29 weeks 6 days, or 31 weeks 6 days in moderate category
* Normal karyotype or FISH
* Normal fetal echocardiogram
* Singleton pregnancy
* Willing to remain in the greater Cincinnati area for remainder of pregnancy
* Family considered and decline option of termination of the pregnancy at less than 24 weeks 0 days
* Family meets psychosocial criteria

Exclusion Criteria:

* Patient \< 18 years old
* Multi-fetal pregnancy
* Rubber latex allergy
* Preterm labor, cervix shortened (\<15 mm) or uterine anomaly strongly predisposing to preterm labor, placenta previa
* Bilateral CDH, isolated left sided CDH with an O/E \> 30%
* Additional fetal anomaly by ultrasound, MRI, or echocardiogram
* Chromosomal abnormalities
* Maternal contraindications to fetoscopic surgery or severe maternal condition in pregnancy
* Incompetent cervix with or without a cerclage
* Placental abnormalities known at time of enrollment
* Maternal HIV, Hepatits B, Hepatitis C
* Maternal uterine anomaly
* No safe or technically feasible fetoscopic approach to balloon placement
* Participation in another intervention study that influences maternal and fetal morbidity and mortality or participation in this trial in a previous pregnancy
Effect of Fish Oil on Markers of the Metabolic Syndrome in Overweight Adolescent Boys

The aim of the study is to investigate if dietary fish oil has a beneficial effect on blood pressure, insulin sensitivity, blood lipid profile, body composition and metabolic rate in healthy, but slightly overweight, teenage boys.

We hypothesized that the n-3 long chain polyunsaturated fatty acids from fish oil might have greater effect during growth and development, as intervention trials studying the effect of fish oil on babies have shown greater effects than in adults.


Eligibility Criteria:
Inclusion Criteria:

* Weight above the 90th percentile for height and age.

Exclusion Criteria:

* Smoking, severe illnesses.
Primary and Secondary Hemostasis in Elective Coronary Artery Bypass Graft Surgery

Patients undergoing elective coronary artery bypass graft surgery (CABG) are treated with platelet inhibitors to reduce myocardial infarction and mortality.However, this can increase perioperative bleeding. A retrospective analysis of the data in our institution has revealed a significant increase in transfusion requirements after elective CABG since 5 years. The aim of our study is to observe if this increase in transfusion requirements is due to platelet inhibitors or due to other coagulation abnormalities resulting from other anticoagulants.


Eligibility Criteria:
Inclusion Criteria:

* coronary artery bypass graft surgery with or without cardiopulmonary bypass

Exclusion Criteria:

* emergency; redo cardiac surgery; combined cardiac surgery; patients with renal insufficiency; patients with acquired coagulation abnormalities
Family Members Affected by Substance Use Disorder - a Follow-up Study

The present study registration relates to a quantitative sub-study of a larger mixed method study, including also a qualitative sub-study. Together, these investigations will provide complementary insights. The quantitative study is a follow-up study of close relatives (\> 16 years) of patients in treatment for substance use disorder (SUD) who participated in a group-based 4-day psychoeducational program.

The study is a follow-up study of close relatives (\> 16 years) of patients in treatment for SUDs who participated in a group-based 4-day psychoeducational program. The investigators will examine whether the family intervention in the specialized treatment services has benefits in terms of typical patient reported outcomes; physical complaints, psychological functioning, family functioning and QoL. The data collection has been finalized in 2017.

Eligibility Criteria:
Inclusion Criteria:

* All participants in a family program

Exclusion Criteria:

* None