cyrilzakka/clinical-trials huggingface dataset:
Painful HIV Neuropathy and Alpha-Lipoic Acid

HIV is associated with painful peripheral neuropathy. Disability is often significant. Alpha-Lipoic Acid's antioxidant properties may have benefit in this condition.

HIV is associated with painful distal peripheral polyneuropathy in up to 35-50% of those without AIDS and in more than 70% of those with advanced disease. The condition is progressive but may be halted with disease remission. Disability is often significant. Peripheral nerve axons and sensory neuron cell bodies in the dorsal root ganglia are the principal targets of the process leading to symptoms. Alpha-lipoic acid occurs naturally in every cell of the body. In high concentrations it acts as an anti-oxidant which regenerates other anti-oxidants and promotes glutathione synthesis. Clinical studies for diabetic neuropathy have shown significant benefit at daily oral doses that are well-tolerated.

This placebo-controlled study is designed to evaluate the effects of daily oral alpha-lipoic acid supplements (600mg, three times per/day) plus standard medical care in the treatment of painful HIV-associated neuropathy over a 24-week period in adult subjects. Possible benefits of the study include reduction in pain and disability, reduced use of medications, and enhanced cellular metabolism.

Eligibility Criteria:
Inclusion Criteria:

* HIV-seropositive
* Distal peripheral sensory neuropathy as diagnosed by a neurologist with pain or paresthesia, with or without numbness or weakness
* Able to understand and participate in protocol activities
* Able to give informed consent
* Under the care of a UNC ID Clinical physician for at least 2 months
* Able to document pain characteristics, use of pain medications, and other assessment instruments and characteristics
* On stable antiretroviral therapy (or none) for 12 weeks prior to enrollment
* No changes in peripheral neuropathy pharmacologic treatment for 12 weeks prior to enrollment

Exclusion Criteria:

* Any significant cognitive impairment or psychosis
* Pregnancy or anticipated pregnancy (women of child-bearing potential must agree to use birth control for the duration of the study)
* Undergoing any current treatment for malignancy, including chemotherapy or radiation therapy within the past year
* Concurrent or prior use of a-LA
* Known non-HIV risk factors for peripheral neuropathy, such as DM, B12/folate deficiency; thyroid dysfunction; hx of exposure to lead, mercury, arsenic, thallium (prior diagnostic tests permitted), other heavy metals or complex hydrocarbons
* Use of metronidazole, isoniazid or other furantoins
* Suspected or documented thiamin deficiency
* Active alcoholism
* Allergy to a-LA
* Hx of 'significant' use of anti-oxidant supplements during the two months prior to study entry
Prognostic Value of Progesterone for In Vitro Fertilization (IVF) Outcome

This observational study attempts to investigate the potential role of serum progesterone levels on the day of hCG administration (thus, the end of the follicular phase) on the probability of pregnancy, in patients undergoing IVF with the use of GnRH antagonists and recombinant gonadotrophins.

There has been evidence, that increased serum levels of progesterone are associated with a decreased probability of pregnancy after IVF.

This study will attempt to explore the role of progesterone on the outcome of IVF, by closely monitoring its levels during the late follicular phase.


Eligibility Criteria:
Inclusion Criteria:

* Age \< 40 years
* Basal FSH \< 12 IU/L
* Basal P \< 1.6 ng/mL

Exclusion Criteria:

* Presence of cystic formations at the ovaries during the basal ultrasound scan (prior the initiation of stimulation)
* Women with polycystic ovaries syndrome (PCOS)
* Women with Stage III-IV Endometriosis
* Women with a pathological condition of the adrenal glands
Local Anesthetic Nebulization and Instillation for Pain Control After Laparoscopic Surgery

Studies evaluating intraperitoneal local anesthetic instillation for pain relief after laparoscopic procedures have provided conflicting results. This randomized, double-blind study was designed to assess the effects of a novel intraperitoneal local anesthetic administration technique using nebulization on pain relief after laparoscopic cholecystectomy.

Studies evaluating intraperitoneal local anesthetic (LA) instillation for pain relief after laparoscopic cholecystectomy have provided conflicting results. One of the factors that might contribute to failure of the instillation technique may be related to inadequate distribution of local anesthetic throughout the peritoneal surface. In contrast, nebulization should provide a uniform spread of drugs throughout the peritoneal cavity and thus may be beneficial to improve pain relief after laparoscopic procedures. A recent study reported that bupivacaine nebulization significantly reduced pain after laparoscopic cholecystectomy compared with bupivacaine instillation in the gallbladder bed. However, these investigators used a custom-made nebulization system that needs a separate gas source and tubing that is cumbersome and may not be easily available.

Recently, the investigators reported that a microvibration-based nebulization device (Aeroneb Pro® system, Aerogen, Galway, Ireland) could be used for ropivacaine delivery into the insufflation gas required to create pneumorpeitoneum. The investigators hypothesized that intraperitoneal ropivacaine nebulization would provide superior pain relief after laparoscopic cholecystectomy than intraperitoneal ropivacaine instillation. This randomized, double blind, controlled clinical trial was designed to assess the analgesic efficacy of ropivacaine nebulization using the Aeroneb Pro® device laparoscopic cholecystectomy compared with intraperitoneal ropivacaine instillation.

Eligibility Criteria:
Inclusion Criteria:

* ASA Score I-III
* Scheduled for laparoscopic cholecystectomy
* Free from pain in preoperative period
* Not using analgesic drugs before surgery
* Without cognitive impairment or mental retardation
* Written informed consent

Exclusion Criteria:

* Emergency/urgency surgery
* Postoperative admission in an intensive care unit
* Cognitive impairment or mental retardation
* Progressive degenerative diseases of the CNS
* Seizures or chronic therapy with antiepileptic drugs
* Severe hepatic or renal impairment
* Pregnancy or lactation
* Allergy to one of the specific drugs under study
* Acute infection or inflammatory chronic disease
* Alcohol or drug addiction
Immunogenicity Study of a Reduced (4-dose) Vaccine Schedule and Rabies Immunoglobulins

Reduced 4-dose intramuscular rabies vaccination schedule was announced by US-ACIP and WHO to be one of the post-exposure prophylaxis regimens. However, concurrent usage of this regimen with rabies immunoglobulin have never been studied in the aspect that the immunity level would above the protective level required by WHO (0.5 IU/ml) for at least a year period. This study would access this subject.

* Controlled trial study
* All 75 volunteers who had never had rabies immunization would be enrolled and designated into 3 groups.

group 1 : 25 Healthy volunteers age 18 - 60 yr who were attacked by mammals, possible exposed to rabies and had WHO category III exposure, all receive standard post - exposure rabies treatment with 5-dose intramuscular rabies vaccine on day 0,3,7,14,28 and 40 IU/kg of equine rabies immune globulin (ERIG).

group 2 : 25 Healthy volunteers age 18 - 60 yr receive 4-dose intramuscular rabies vaccine on day 0,3,7,14 and 40 IU/kg of equine rabies immune globulin (ERIG).

group 3 : 25 Healthy volunteers age 18 - 60 yr receive 4-dose intramuscular rabies vaccine on day 0,3,7,28 and 40 IU/kg of equine rabies immune globulin (ERIG).

5 cc - Blood would be drawn from all volunteers before vaccination and on day 14, 28, 90 and 360 for rabies neutralizing antibody titers (RNab).

The GMTs of RNab among both groups would be analyzed and compared.

Eligibility Criteria:
Inclusion Criteria:

* healthy volunteers age 18-60 years.

Exclusion Criteria:

* received prior rabies immunization
* pregnancy
* immunocompromised conditions
The Therapeutic Time Window of Mannitol During Craniotomy for Optimal Brain Relaxation in Patients With Supratentorial Tumours

Although mannitol is used for brain relaxation during neurosurgery and in the treatment of raised intracranial pressure; there is not a consensus on its safe, effective dose and the duration of its administration. This study aimed to compare the effects of the mannitol in different use times, on the brain relaxation, electrolyte, lactate levels of the blood, peroperative fluid balance and the volume of the urine in supratentorial mass resection surgeries.


Eligibility Criteria:
Inclusion Criteria:

* Intracranial shift \>3mm
* Scheduled for supratentorial mass resection under elective conditions

Exclusion Criteria:

* Decompensated heart failure
* kidney insufficiency
* Diabetes insipidus,
* Electrolyte imbalance and
* Who are unconscious
Activated Autologous T Cells Against Glioma Cancer Stem Cell Antigens for Patients With Recurrent Glioblastoma

The purpose of this study is to examine the use of activated T cells (ATCs) to assess the safety and tolerability of autologous activated T cells, as measured by the number of Grade 3 or higher toxicities, the number of serious adverse events, and treatment-related toxicities, according to National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI CTCAE) Version 5, to find the maximum tolerated dose. The secondary objectives include evaluating the rate of overall survival, rate of progression-free survival, health-related quality of life parameters, overall response rate, immune response, and tumor stem cell antigen expression.


Eligibility Criteria:
Inclusion Criteria:

* Recurrent glioblastoma
* HLA-A1 and HLA-A2 positive
* Complete resection of tumor

Exclusion Criteria:

* Clinically significant pulmonary, cardiac or other systemic disease
* Presence of an acute infection requiring active treatment with antibiotics/antivirals; prophylactic administration is allowed.
* Known human immunodeficiency virus positivity or acquired immunodeficiency syndrome related illness or other serious medical condition.
* Known history of Hepatitis B or Hepatitis C
* Allergy to Dimethyl sulfoxide (DMSO)
* Allergy to gentamicin
Dexmedetomidine Versus Clonidine for Transversus Abdominis Plane Block in Patients Undergoing Elective Caesarean Section

Aim to study the efficacy of co-administered Dexmedetomidine Or Clonidine with Bupivacaine and that of bupivacaine 0.25% alone for Transversus Abdominis Plane (TAP) Block for Postoperative Analgesia in Patients Undergoing Elective Caesarean Section.

* Group 1: bupivacaine 0.25% + Dexmedetomidine 0.5 mcg/kg (a total volume of 40 ml (20 ml each side) was used for the TAP block.)
* Group 2: 20 ml bupivacaine+1ug/kg clonidine bilaterally (a total volume of 40 ml (20 ml each side) was used for the TAP
* Group3: bupivacaine 0.25% + placebo (a total volume of 40 ml (20 ml each side) was used for the TAP A prospective Randomized Interventional double-blind study.

Women, following Caesarean delivery, have even more compelling reasons to receive optimal post-operative pain relief, for improved maternal and neonatal well-being. Also, adequate pain relief helps the patient to ambulate early and prevent any thrombotic incidents . Dexmedetomidine, an imidazole compound, is the pharmacologically active dextroisomer of medetomidine that displays specific and selective α 2-adrenoceptor agonist activity and causes sedation, analgesia without any delirium, or respiratory depression. The mechanism of action is unique and differs from those of currently used agents, including clonidine.

Eligibility Criteria:
Inclusion Criteria:

* parturients scheduled to undergo cesarean section under spinal anesthesia

Exclusion Criteria:

* Patients who refused spinal anesthesia
* women with chronic pelvic pain or on chronic morphine use
* history of drug allergy
* coagulation disorder
Tissue Doppler Echo Imaging of Heart Function After Transplant

There are many children born with Congenital Heart Disease. Many of these children have to undergo surgical procedures to correct the problem. Some patients must eventually get a new heart. Once they get a new heart, we have to have ways to determine how well the new heart is doing inside of the body. Tissue Doppler Imaging is one way of doing so. Tissue Doppler Imaging is like an ultrasounds. It takes pictures of the heart. In addition to Tissue Doppler Imaging, there is a newer non-invasive procedure called Tissue Synchronization Imaging which will allow us to see how well the new heart is working as well. In this study we would use both techniques to determine how well the new heart is working.

Heart transplantation is the only hope for children with end stage heart disease. Eventually cardiac deterioration occurs and leads to death or re-transplantation. Our understanding of the pathophysiology of cardiac dysfunction in these children is incomplete. The time course of the dysfunction process either in the RV and/or the LV, systole or diastole has never been studied in children. No meaningful TSI quantitation has ever been performed in a large pediatric OHT patient population. The long-term goal of this study will be the detection of functional myocardial changes associated with known stages post heart transplantation using TDI and TSI. These achievements impact the survival and quality of life of children after cardiac transplantation.

Research Design and Methods

All subjects who are treated in the transplant clinic will be approached for possible participation into the study. These patients will include newly transplanted (OHT) patients as well as patients who underwent OHT prior to the enrollment year. The following procedures will occur at each study visit:

Echocardiographic assessment Standard 2-dimensional, M-mode, and Doppler or 3-dimensional echocardiography evaluation will be performed. We will assess cardiac function using left ventricular shortening (SF) and ejection fractions (EF). The EF will be calculated using both M-Mode and by Simpson's rule. We will also perform tissue synchronization imaging (TSI) and tissue Doppler imaging (TDI) using the GE Vivid 7 echocardiographic system. Both TSI and TDI will assist investigators in assessing mechanical synchrony. In newly transplanted patients, these echocardiographic assessments will occur during the first 5 days to serially measure ventricular synchrony during the acute post-operative period. For older transplant patients and for new transplant patients greater than five days out from transplantation, echocardiographic studies will occur at all follow-up clinic visits as determined by physician preference.

Clinical assessment Clinical evaluation will be performed during all follow-up visits in order to track unrecognized complications or adverse events. As is standard, all patients undergoing transplantation follow-up will have an electrocardiogram (EKG) performed to assess rhythm.

Eligibility Criteria:
Inclusion Criteria:

- Children who have had cardiac transplant within one year.

Exclusion Criteria:

-
A Study of Effect of Megakaryocytes and Platelets in Breast Cancer

Determining if Megakaryocytes and Platelets are Harmful or Helpful in Breast Cancer Cell Metastasis

The purpose of this study is to determine how megakaryocytes (cells in the bone marrow responsible for making platelets, which are necessary for blood clotting) affect the survival and growth/division patterns of breast cancer stem cells, and the effects of breast cancer cells on megakaryocyte survival and function. Through chart review, the study team will look at the relationship between different blood components and different breast cancer diagnoses.

Eligibility Criteria:
Inclusion Criteria:

Cohort 1-Biopsy negative

* Females age 18 and above

Cohort 2-Biopsy positive for carcinoma in situ (ductal, lobular, or other)

* Females age 18 and above
* Any subtype of breast cancer

Cohort 3-Biopsy positive for Stage 1, 2, or 3 invasive carcinoma (ductal, lobular, or other)

* Females age 18 and above
* Any subtype of breast cancer
* Have no distant metastases

Cohort 4-Stage 4 Metastatic Disease

* Females age 18 and above
* Any subtype of breast cancer

Exclusion Criteria:

* Previous diagnosis with a known platelet disorder such as: Bernard Soulier disease, Jacobsen syndrome, Lowe syndrome, Thrombocytopenia, Thrombotic thrombocytopenic pupura, Von Willebrand disease, or the equivalent. Any condition in which antiplatelet or anticoagulant therapy with one of the following medications is being prescribed: Clopidogrel (Plavix), Warfarin (Coumadin or Jantoven), Prasugrel (Effient), or Ticagrelor (Brilinta).

Cohort 1-Biopsy negative

* Males
* Females less than age 18

Cohort 2-Biopsy positive for carcinoma in situ (ductal, lobular, or other)

* Males
* Females less than age 18
* Currently undergoing neoadjuvant therapy

Cohort 3-Biopsy positive for Stage 1, 2, or 3 invasive carcinoma (ductal, lobular, or other)

* Males
* Females less than age 18
* Presence of distant metastases
* Currently undergoing neoadjuvant therapy

Cohort 4-Stage 4 Metastatic Disease

* Males
* Females less than age 18
* Currently undergoing neoadjuvant therapy
* Less than 30 days from last adjuvant treatment for Stage I-III Breast Cancer (may be on Trastuzumab, Pertuzumab, or endocrine therapy only for maintenance therapy from their prior breast cancer diagnosis)
Comparison of Effectiveness of Nasal CPAP and Nasal IMV in Early Rescue Surfactant Treatment in Preterm Infants

The investigators aimed to compare the efficacy of nasal intermittent mandatory ventilation (IMV) and nasal continuous positive airway pressure (CPAP) in early rescue surfactant treatment in preterm infants.


Eligibility Criteria:
Inclusion Criteria:

- Gestational age 26-32 weeks

The criteria for failure were met by at least 1 of the following:

* pH: 7.10 and PaCO2: 70 mm Hg
* Recurrent apnea with \>3 episodes (Prophylactic caffeine were used in all infants)
* Single episode of apnea that required bag-and-mask ventilation
* PaO2: 50 mmHg with a fraction of inspired oxygen of \>0.5.

Exclusion Criteria:

* Major congenital anomalies
* Presence of cardiovascular instability
* Intubation at admission to the NICU
* Consent not provided or refused
Validity and Reliability of the Turkish Version of the Ottawa Sitting Scale in Hemodialysis Patients With Chronic Kidney Disease

Background:

Prolonged sitting behavior, characterized by minimal energy expenditure, poses significant health risks, especially for chronic kidney disease (CKD) patients undergoing hemodialysis. This sedentary behavior can lead to various health complications and a reduced quality of life (QOL).

Objectives:

This study aims to evaluate the validity and reliability of the Turkish adaptation of the Ottawa Sitting Scale (OSS) in assessing sitting behavior among CKD patients.

Methods:

A total of 130 CKD patients undergoing hemodialysis participated in this cross-sectional study conducted in XXX province between January 2023 and September 2023. The OSS, along with the Physical Activity Scale (FAS), Sitting Behavior Assessment (SBA), and Quality of Life Scale (QOL), was administered. Data analysis involved assessing the internal consistency, factor structure, and concurrent validity of the OSS.

Prolonged sitting behavior, characterized by minimal energy expenditure, poses significant health risks, especially for chronic kidney disease (CKD) patients undergoing hemodialysis. This sedentary behavior can lead to various health complications and a reduced quality of life.This study aims to evaluate the validity and reliability of the Turkish adaptation of the Ottawa Sitting Scale (OSS) in assessing sitting behavior among CKD patients. A total of 130 CKD patients undergoing hemodialysis participated in this cross-sectional study conducted in XXX province between January 2023 and September 2023. The OSS, along with the Physical Activity Scale (FAS), Sitting Behavior Assessment (SBA), and Quality of Life Scale (QOL), was administered. Data analysis involved assessing the internal consistency, factor structure, and concurrent validity of the OSS.

Eligibility Criteria:
Inclusion Criteria:

* a diagnosis of CKD undergoing hemodialysis treatment for at least 6 months no abnormalities in cooperation or communication, and willingness to participate in the study.

Exclusion Criteria:

* Inability to comprehend instructions
* Presence of any other disease that may affect sitting
* Experiencing acute or chronic musculoskeletal injuries, pain, inflammation or deformities, and refusal to participate in the study.
LIraglutide and Beta-cell RepAir (LIBRA) Study

Type 2 diabetes mellitus (T2DM) is a chronic metabolic disorder characterized by progressive deterioration in the function of the pancreatic beta-cells, which are the cells that produce and secrete insulin (the hormone primarily responsible for the handling of glucose in the body). We propose a double-blind, randomized controlled study comparing the effect of liraglutide (a novel anti-diabetic drug with beta-cell protective potential) versus placebo, on the preservation of beta-cell function over one year in patients with T2DM. This study may demonstrate an important beta-cell protective capacity of liraglutide.

In this study, patients with type 2 diabetes who meet randomization criteria will be randomized to either liraglutide or placebo, with serial assessment of beta-cell function over 48 weeks follow-up. The hypothesis under study is whether liraglutide can preserve beta-cell function.

Eligibility Criteria:
Inclusion Criteria:

* men and women between the ages of 30 and 75 years inclusive
* physician-diagnosed type 2 diabetes of \</= 7 years duration
* negative for anti-GAD antibodies
* on 0-2 oral anti-diabetic medications
* A1c at screening between 5.5% and 9.0% inclusive, if on oral anti-diabetic medications, or between 6.0% and 10.0% inclusive, if not on oral anti-diabetic medications

Exclusion Criteria:

* use of insulin, GLP-1 agonist, or dipeptidyl peptidase-4 (DPP-4) inhibitor
* type 1 diabetes or secondary forms of diabetes
* major illness with life expectancy \< 5 years
* involvement in another study requiring drug therapy
* hypersensitivity to insulin, liraglutide, or metformin
* renal dysfunction
* hepatic dysfunction
* history of pancreatitis
* family or personal history of Multiple Endocrine Neoplasia type 2 (MEN-2) or familial medullary thyroid carcinoma
* personal history of non-familial medullary thyroid carcinoma
* malignant neoplasm requiring chemotherapy, surgery, radiation or palliative therapy within the previous 5 years (with the exception of basal cell skin cancer)
* excessive alcohol consumption
* unwillingness to undergo multiple daily insulin injection therapy
* unwillingness to perform capillary blood glucose monitoring at least 4 times per day during intensive insulin therapy
* congestive heart failure
* pregnancy