cyrilzakka/clinical-trials huggingface dataset:
Dosing of Methadone for Spine Surgery

This study compares two methods of dosing methadone for complex spine cases

Patients with spine surgery experience a significant amount of pain that can interfere with healing, rehabilitation and contribute to morbidity in the post-operative period. This study will compare post-operative opioid requirement at 24 and 48 hours to determine if methadone given in small aliquots until respiratory depression can act as a self-control to determine the correct dose required.

Eligibility Criteria:
Inclusion Criteria:

1. Patients must consent to participate and sign the IRB-approved informed consent prior to beginning any study specific procedures.
2. At or between the ages 18 to 75 years.
3. Undergoing multilevel thoracic, thoracolumbar and/or lumbar spine surgery with instrumentation and fusion.

Exclusion Criteria:

1. Methadone or buprenorphine use.
2. Morbid obesity with BMI\>40 Kg/m2.
3. Chronic renal failure with creatinine\>2.0 mg/dL.
4. Liver failure as determined by cirrhosis or history of fulminant hepatic failure.
5. Current or historical alcohol abuse.
6. Current or historical drug abuse.
7. Patients with history of prolonged QTc, as defined as a QTc value \>450 ms in males and \>460 ms in females.
8. Patients with ASA status IV or V.
9. Surgical diagnosis including spine tumor, infection, or trauma.
10. In the Principal Investigator's opinion is not a candidate for the study.
11. Unwilling to sign the informed consent form.
Study of Endostatin Combined With Docetaxel in the Treatment of Advanced Non-small Cell Lung Cancer Patients

The purpose of this study is to examine the efficacy and safety of endostatin combined with Docetaxel in advanced Non-Small-Cell Lung Carcinoma (NSCLC) patients failure to first-line or second-line chemotherapy.


Eligibility Criteria:
Inclusion Criteria:

* Patients who were diagnosed by the histologic, cytologic diagnosis of IIIB (malignant hydrothorax or hydropericardium) or IV non-small cell lung cancer
* ≥ 18 years old
* patients who have received more than one regimen of platinum-based chemotherapy; patients who have received EGFR monoclonal treatment could also be enrolled
* At least one target lesion diameter spiral CT ≥ 1 cm, or the common CT ≥ 2 cm, and can be measured by imaging tools
* have an interval of more than 4 weeks from the last chemo- or radio-therapy; 2 weeks from the last targeted therapy
* ECOG 0-2
* Expected life time longer than 3 months
* Normal laboratory values:

  * leucocyte≥ 4×109/L
  * neutrophil≥ 1.5×109/L
  * platelet≥90×109/L
  * Hemoglobin≥ 9g/L
  * ALT and AST ≤3×ULN (≤5×ULN if liver metastasis)
  * serum creatinine\<1.5 mg/dl
  * bilirubin \<1.5×ULN
* No allergy to biological drug
* Sign the consent forms

Exclusion Criteria:

* Patients who have previously received Docetaxel or anti-VEGF inhibitors
* Severe symptomatic heart disease
* Female patients during their pregnant and lactation period, or patients without contraception
* Severe uncontrolled infection
* Uncontrolled neurologic or psychiatric disease; Uncontrolled primary or metastatic brain tumor
* Patients with other malignant tumor,except for basal cell carcinoma,squamous cell carcinoma and carcinoma in situ
* Patients have accepted other clinical trials
ω3 LCPUFAs for Healthy Growth and Development of Infants and Young Children in Southwest Ethiopia

New approaches are needed to prevent growth failure in children from low- and middle-income countries (LMIC). To date, nutrition intervention studies have focused on micronutrient and energy content of complementary foods and have yielded only small to moderate effects on growth and development. There appears to be a missing link that mediates and reduces the expected beneficial effect. Child populations in LMIC show an asymptomatic environmental enteropathy that is characterized by a reduced size of the small intestinal villi, decreased gut integrity and a chronic inflammatory response in the gut. Results from studies in industrialized countries suggest that ω3 long-chain polyunsaturated fatty acids (ω3 LCPUFAs) improve immune response and gut integrity. These reported beneficial effects could result in even more important physiological implications for children from LMIC and will ultimately contribute to their healthy growth and development.

The hypothesis of the OME³Jim study is that an increased intake of ω3 LCPUFAs through complementary foods and human milk has an effect on infant growth and development in a context of high malnutrition rates and low ω3 LCPUFAs intake. This study will identify whether intake by either or both mother and infant is more effective.

The specific objectives of the OME³Jim study are:

1. To test the effect of supplementing infants with an ω3 LCPUFAs fortified food supplement on infant growth, morbidity, nutritional status and development;
2. To test the effect of supplementing lactating mothers with an ω3 LCPUFAs oil capsule on infant growth, nutritional status and development;
3. To test the combined effect (dose response) of supplementing ω3 LCPUFAs to lactating mothers and infant on infant growth, morbidity, nutritional status and development:
4. To test the effect of ω3 LCPUFAs supplementation on ω3 LCPUFA status in infants and human milk.


Eligibility Criteria:
Inclusion Criteria:

* Singleton infants
* 6-12 months old
* Not suffering from acute malnutrition (wasting): WHZ \> -2 , no edema
* Infants currently being breastfed
* Anticipated local residence for the study duration
* Not planning to leave the study area for more than 1 month

Exclusion Criteria:

* Current supplement use or medical treatment of infant and/or mother
* Infants developing severe anemia (\<70 g/L) or edema are referred to the nearby health institution for evaluation and treatment, and are omitted from the trial
* Presence of congenital abnormalities
Establishment of Genetic Basis for Neurological Disease by Genetic Screening

Hereditary neurological disorders are relatively common in paediatric neurological practice, but it has considerable overlap with adult neurological disorders. It is a group of of genetic diseases, most of which with a Mendelian inheritance affecting neurological system. Pathogenic mechanisms of these diseases are not fully understood. There is currently no effective therapy for most of these diseases. Disease-specific and patient- specific iPS cells would provide useful source of cells in culture modeling in these diseases.

In this study, disease-specific iPS cell lines repositories from hereditary neurological disease patients will be established. The cell lines will be registered and make them available to other investigators.

The human iPS is generated by direct reprogramming of human somatic cells. These hiPS cells can give rise to most tissue types in the human embryo and possess many of the properties of human embryonic stem cells (hESC). The big advantage of human iPS cell over hESC is that it circumvents most of the limitations of hESC and remains the pluripotency for regeneration of cells and tissues. The unique capacity of self-renewal of iPS can provide unlimited supply of pluripotent stem cells for study. The patient-specific iPS cell lines should fundamentally eliminate the concern of immune rejection and ethical issues. The disease-specific iPS will facilitate the study of the mechanism of nucleotide expansion. It is the ideal medium to study the dynamic changes of the expansion from stem cell stage to different differentiation stages. It also creates a platform for drug development. The establishment of iPS stem cells will also make it realistic for target gene replacement/correction therapy.

Study subjects will be identified at the members from the Hong Kong Spinocerebellar ataxias (SCA) association and neurology clinic in Prince of Wales Hospital. Patients identify based on the diagnosis, genetic test results and inclusion and exclusion criteria.

10ml blood sample for genetic screening will be collected. Skin biopsy will only be scheduled if pathogenic mutation was identified by the genetic screening test and generation of iPS is considered necessary to study the pathogenic mechanism of the disease.

Eligibility Criteria:
Inclusion Criteria:

1. Individuals at age 18 years or older who have presumed hereditary neurological disease.
2. Individuals or his/her guardian who can provide the informed consent.

Exclusion Criteria:

1. Individuals who are allergic to local anesthetics.
2. Individuals who have serious medical conditions that restrict their ability to tolerate skin biopsy.
3. Individuals who have history of bleeding diathesis or use of anticoagulant medications. Patients taking nonsteroidal anti-inflammatory agents will be asked to discontinue these medications 3 days prior to skin biopsy.
Oral Administration of AlequelTM for Patients With Inflammatory Bowel Disease (IBD)

Oral administration of Alequel, a mixture of proteins derived from the patient's bowel will be tested in patients with inflammatory bowel disease.

Oral administration of Alequel prepared from patients biopsies will be tested in patients with inflammatory bowel disease to determine its anti inflammatory effect.

Eligibility Criteria:
Inclusion Criteria:

* Crohn's disease

Exclusion Criteria:

* Immune suppression
Collection of Biological Samples From Patients Treated With CAR-T Cells for Hematological Malignancies

Development of CAR-T cell against CD19 B lymphoma and Acute Lymphoblastic Leukemia leaded to 2 authorized medication: Yescarta and Kymriah. Despite impressive outcomes in 3 phase II studies, never met in relapsed or refractory diseases, half of the patients don't respond to this treatment.This can be explained by a low expansion, functional alteration or short persistence of infused cells. Determination of reasons for treatment failure is the first step for optimization of this therapeutics. This project aims to bank blood samples from a cohort of patients treated with CAR-T cell for hematological malignancies in Montpellier University Hospital. Clinical data related to samples will be collected. This samples will be used to determine factors influencing efficacy of CAR-T cells treatments.

Development of CAR-T cell against CD19 B lymphoma and Acute Lymphoblastic Leukema leaded to 2 authorized medication: Yescarta and Kymriah. Despite impressive outcomes in 3 phase II studies, never met in relapsed or refractory diseases, half of the patients don't respond to this treatment.This can be explained by a low expansion, functional alteration or short persistance of infused cells. Determination of reasons for treatment failure is the first step for optimization of this therapeutics. This project aims to bank blood samples from a cohort of patients treated with CAR-T cell for hematological malignancies in Montpellier University Hospital. Clinical data related to samples will be collected. This samples will be used to determine factors influencing efficacy of CAR-T cells treatments.

Eligibility Criteria:
Inclusion Criteria:

* patient treated by CAR-T cell at the University Hospital of Montpellier

Exclusion Criteria:

* refusal to sign consent form
* pregnant woman
* major protected
Inhaled Iloprost as an Adjunct to Inhaled Nitric Oxide in Pediatric Critical Care Patients

The purpose of this study is to determine whether inhaled iloprost is safe and effective in pediatric patients with pulmonary hypertension who are sick in the intensive care unit.

Inhaled nitric oxide (NO) is used in the management of all causes of pediatric pulmonary hypertension. Despite widespread use of nitric oxide to treat critically ill mechanically-ventilated pediatric patients with pulmonary hypertension, response to therapy is not universal. Nitric oxide fails to improve oxygenation in approximately 30% of these patients. Nonresponders to nitric oxide have few treatment options. Iloprost is the only other medication approved for inhalational delivery in the treatment of pulmonary hypertension. Inhalation therapy for pulmonary vasodilatation in critically ill children is inherently more attractive than oral or intravenous therapies due to the ability to deliver medication directly to the lung and to decrease systemic effects. The use of inhaled iloprost has been reported to decrease pulmonary vascular resistance in many pediatric pathologic settings, including combination therapy with nitric oxide.

Eligibility Criteria:
Inclusion Criteria:

* Birth to 21 years of age
* Diagnosis of pulmonary hypertension must fit into one of three categories

  * neonatal hypoxic respiratory failure
  * congenital heart disease
  * acquired/acute respiratory distress syndrome (lung disease)
* Parents of subject must be able and willing to give written informed consent and comply with the requirements of the study protocol and must authorize release and use of protected health information
* Patients who remain on nitric oxide at 12 to 18 hours after initiation
* Patients who are transferred to an intensive care unit already on inhaled nitric oxide from another institution will be treated as if nitric oxide therapy was started at the time of admission to the unit
* Patients will be enrolled only after a clinical decision to treat with nitric oxide has been made by the treating physician

Exclusion Criteria:

* Corrected gestational age less than 35 weeks
* Patients with potentially fatal non-cardiopulmonary co-morbidities (e.g. hepatic, neurologic, renal)
* Known or suspected fatal genetic syndrome
* Patient with cardiac failure secondary to significant left-sided obstructive lesions
* Patient on ECMO
* Patient on any other form of prostacyclin
* Patient on any medication with known NO production, e.g., nitroprusside
* Patient on an endothelin receptor antagonist (e.g. bosentan)
* Patient on sildenafil
* Patient on whom clinicians do not agree to follow standard inhaled nitric oxide weaning protocol
* Patients who have known hypersensitivity to prostacyclin or any of its components
* Patient who is pregnant
* Patient with platelet count less than 50,000
Daily Living Activities in Young Adults With Cerebral Palsy

This study explored the relationship between sensory function and occupational performance in young adults with Cerebral Palsy. Using standardized assessments, researchers compared tactile sensitivity and discrimination between individuals with CP and neurotypical controls, and examined how these sensory variables relate to motor function, ADLs, and IADLs.

Background: Sensory impairments are increasingly recognized as influential factors in the occupational performance of individuals with Cerebral Palsy (CP). Although prior studies have explored this relationship in children, evidence in young adults remains limited.

Objective: This study aimed to compare tactile sensitivity and discrimination in young adults with CP and neurotypical individuals, and to examine their association with motor-related variables relevant to occupational performance: muscle tone, grip strength, manual dexterity, Activities of Daily Living (ADLs), and Instrumental Activities of Daily Living (IADLs).

Methods: A multicenter cross-sectional study was conducted involving two groups of 36 participants aged 16-45 years. Sensory and motor variables were assessed using the Semmes-Weinstein Monofilaments, Two-Point Discrimination Test, Modified Ashworth Scale, Digital Dynamometer, Box and Block Test, Functional Independence Measure, and the Lawton and Brody Scale.

Conclusion: Findings highlight the relevance of sensory function in the occupational performance of young adults with CP. These results underscore the need for occupational therapy interventions that integrate sensory assessments and target sensory-motor integration to improve functional independence and participation.

Eligibility Criteria:
Inclusion Criteria:

* young people and adults with a medical diagnosis of CP, who had a motor condition of hemiparesis, diparesis, or tetraparesis;
* aged between 16 and 45 years
* had a minimum score of 19 on the Mini Mental State Examination cognitive assessment scale
* authorized their participation in the study by signing an informed consent form. In cases between the ages of 16 and 18 years, informed consent was signed by the participants and their parents or legal guardians

Exclusion Criteria:

* any peripheral nerve injury
* shoulder, elbow, wrist or hand injuries
* individuals whose mother tongue was neither Portuguese nor Spanish
Thrust Versus Non-thrust Manipulation in Chronic Low Back Pain

This study aims to verify the effects of Thrust Versus Non-thrust Manipulation on Pain, Trunk Proprioception and Postural Stability in Subjects With Chronic Low Back Pain.

Forty individuals with chronic low back pain will be randomly assigned, by a researcher not involved in data collection, to two treatment groups: Thrust manipulation (side-lying rotational manipulation standardized to the L4-L5 level) or non-thrust manipulation (side-lying grade III rotational non-thrust manipulation). A single treatment session will be provided.

Outcome measurement will be conducted immediately after the treatment session. Data will be collected by a blinded assessor. Between-group differences will be calculated by constructing mixed linear models following an intention-to-treat principle.

Eligibility Criteria:
Inclusion Criteria:

* Age greater than 18 years
* Chronic Low back pain (pain lasting for at least 12 weeks)
* NPRS ≥ 3

Exclusion Criteria:

* Previous surgery or fracture at the lumbar spine
* Pregnancy
* Inflammatory disorders
* Symptoms distal to the gluteal line
* Having received manipulative treatment in the past four weeks
Breastfeeding Education Prepared with Virtual Reality Technology

The breastfeeding software developed with the primiparous study was transferred to virtual reality glasses. This study will be applied to pregnant women and its effect on breastfeeding success and breastfeeding self-efficacy will be investigated.

The goal of this clinical trial is to To learn The Effect Of Pre-Natal Breastfeeding Education Prepared Wıth Virtual Reality Technology On The Breastfeeding Self-Efficiency And Breastfeeding Success Of Primiparous Mothers in The study will be delivered to 60 healthy primiparous pregnant women.The breastfeeding software developed with the primary study was transferred to virtual reality glasses. It will also be implemented in this study. The main questions it aims to answer are:

* Prenatal breastfeeding education prepared with virtual reality technology positively affects the breastfeeding self-efficacy of primiparous mothers.
* Prenatal breastfeeding education prepared with virtual reality technology positively affects the breastfeeding of primiparous mothers.

Participants will Pregnant women in the intervention group will be given breastfeeding training prepared with virtual reality technology and will fill out questionnaires and scales will be filled in on the first and seventh days after birth. Questionnaires will be filled in by pregnant women in the control group, and the scales will be filled out only on the first and seventh days.

Researchers will compare breastfeeding education given with virtual reality glasses with the control group to see whether it has an effect on breastfeeding success and breastfeeding self-efficacy.

Eligibility Criteria:
Inclusion Criteria:

* Between the ages of 18 and 35
* literate,
* Pregnant women who are at 37 weeks of gestation and above,
* Those with healthy pregnancies (singleton pregnancy, no systemic/chronic disease, etc.) -Primiparous pregnant women-
* Vaginal birth planned,
* planning to breastfeed,
* Those who do not have any problems with their breasts that would make breastfeeding difficult (collapsed, missing tip, wound on the nipple, etc.),
* Pregnant women who do not have vision, hearing or communication problems
* Pregnant women who do not have any problems will be included in the study.

Exclusion Criteria:

* Occurrence of a situation that prevents sucking
* Baby with congenital anomalies
Effect of Creatine on Serum and Urine Creatinine

Background: Creatinine (Crn) concentration is used to assess renal function via calculation of GFR (Glomerular Filtration Rate). By RIFLE (Risk, Injury, Failure, Loss, End Stage Kidney Disease) criteria, acute kidney injury (AKI) and acute renal failure (ARF) are defined by a two-fold and three-fold increase in serum Crn, respectively. Crn is a breakdown product of proteins and circulating creatine, and it is generally a benign product present in serum. Creatine is a nutritional supplement that has been available since 1993, and it is widely used among athletes today.

Methods: In an IRB approved, blinded crossover trial, 25 human volunteers ingested 2 creatine supplements to determine any associated statistically significant increase in serum Crn and clinically significant increase in serum Crn to a degree associated with AKI or ARF. Urine samples were also collected to examine excretion patterns after an ingested sample. Participants ingested 10 gm of creatine ethyl ester (CEE) or creatine monohydrate (CrM) and had serum Crn assayed at 0, 1, 2, 3, 4, 5 and 24 hours. Urinary Crn levels were assayed at 0, 1.5, 3, 5 and 24 hours. Exclusion factors were any history of renal disease or use of creatine within the last month. Statistical analysis was performed by Wilcoxon Matched-Pair Signed Ranks Test and descriptive summary statistics were performed.


Eligibility Criteria:
Inclusion Criteria:

* Age over 18
* Human

Exclusion Criteria:

* Use of any form of creatine within 4 weeks prior to participation in study.
* Pregnancy
* History of elevated creatinine or renal insufficiency
* History of PKU
Study of Latent Tuberculosis Infection (LTBI) by High Resolution Scanner

It is traditionally considered that someone with a positive tuberculin skin test (TST) (and/or positive result in Cell Interferon-Gamma Release Assay (TIGRA), depending on the different countries' guidelines) is infected but not ill when the absence of lesions is demonstrated in a thorax X-Ray assay. Even though, the experiences described in literature using cows and pigs as animal models for the study of LTBI demonstrate the presence of this kind of lesion in the animals, even too small to be detected by X-Ray assay, which would suggest they also could happen in human LTBI. Nowadays, the High Resolution Scanners (HR TC) offer the possibility of detecting any lesion approximately 1 mm in diameter, so the investigators plan to use this technique to screen people already infected by M. tuberculosis (but not ill, following the Diagnosis Standard Guidelines).

Additional pathological analysis of resected and post-mortem tissues will provide lesion-based profiles of humans infected with tuberculosis.

It is traditionally considered that the development of LTBI is due to the M. tuberculosis ability to develop a dormancy state within well-structured lesions (granulomas), which can remain in the lung of the host even for life. The investigators have developed a new original hypothesis based on scientific evidence that takes into account the idea that a lesion cannot be held forever, because the host tends to remove any lesion in order to rebuild the original parenchyma, in a healing process. Even if M. tuberculosis can remain in a dormant/non-replicating state for a long period, this is an important but not sufficient factor to explain the LTBI. The Dynamic Hypothesis tries to explain the existence of LTBI in spite of the healing process that could remove it by a constant reinfection of the host's tissue.

Eligibility Criteria:
Inclusion Criteria:

* People with TST+ (plus positive TIGRA result, if possible) and normal thorax X-ray assay (normal as absence of any detectable lesion)

Exclusion Criteria:

* Active TB
* Any medical condition or illness that could compromise the volunteer's health if entering the project