cyrilzakka/clinical-trials huggingface dataset:
NATURAL HISTORY-Hepatitis C Virus/ Human Immunodeficiency Virus Coinfection

The purpose of this study was to describe the time course and extent of hemoglobin (Hb) changes and the erythropoietic response to PEG-IFN/RBV (Pegylated Interferon and Ribavirin)-induced anemia In HCV(hepatitis C virus)/HIV (human immunodeficiency virus) co-Infected subjects.

Patients receiving combination therapy for chronic hepatitis C virus (HCV) infection (standard or pegylated interferon alfa \[PEG-IFN\] in combination with ribavirin \[RBV\]) frequently develop moderate to severe anemia. In large, prospective, clinical trials of PEG-IFN alfa-2b and PEG-IFN alfa-2a, the reported mean decreases in hemoglobin (Hb) were 2.5 g/dL, and 3.7 g/dL, respectively. Furthermore, in a retrospective study, 54% of standard interferon/RBV-treated patients had hemoglobin decreases of at least 3 g/dL. It is important to understand the causes, natural history, and risk factors associated with HCV therapy-induced anemia, because such decreases in hemoglobin can result in RBV dose reduction or discontinuation, which may decrease the likelihood of a virologic response by patient. Erythropoietin is an endogenous hormone that acts in the bone marrow to increase the number of erythroid progenitor cells (red blood cells). Normally, a decrease in the hemoglobin level is accompanied by an increase in the serum erythropoietin (sEPO) level, which will ultimately normalize the Hemoglobin level. The relationship between hemoglobin and serum erythropoietin is less apparent in patients with chronic diseases such as cancer and human immunodeficiency virus (HIV) infection. It is not known whether HCV/HIV co-infected patients receiving combination PEG-IFN/RBV therapy have a similarly diminished erythropoietic response to anemia. The objective of this study is to document the pattern of hemoglobin changes and erythropoietic response (from baseline to final assessment) in HCV/HIV co-infected patients receiving combination therapy with IFN / RBV. N/A

Eligibility Criteria:
Inclusion Criteria:

* HIV- infected patients confirmed by HIV-RNA level
* HCV- infected patients confirmed by PCR(polymerase chain reaction) or branched DNA (b-DNA)
* Scheduled to commence combination IFN/RBV therapy on Day 1
* Normal serum creatinine
* On stable antiretroviral regimen (for HIV) for at least 4 weeks
* Life expectancy \> 6 months

Exclusion Criteria:

* Patients with history of any primary hematologic disease
* Anemia attributable to factors such as iron or folate deficiency, pre-treatment
* hemolysis or gastrointestinal bleeding
* Has suspected or confirmed significant hepatic disease from an etiology other than
* HCV (e.g. alcohol, HBV DNA, autoimmune disease etc)
Evaluation of Preoperative N1539 in Colorectal Surgery

The primary objective of this study is to evaluate the safety and tolerability of preoperative dosing of N1539 30 mg in subjects undergoing colorectal surgery, including clinical laboratory tests, wound healing evaluation, incidence of anastomotic leaks, and incidence of Adverse Events (AEs) and Serious AEs (SAEs).


Eligibility Criteria:
Inclusion Criteria:

* Voluntarily provide written informed consent.
* Be planned to undergo primary (no repeat procedures) open or laparoscopic colorectal surgery (laparoscopic expected to require a ≥ 5 cm incision) with bowel resection and/or anastomosis.
* ASA physical status category 1, 2, or 3.
* Female subjects not pregnant or planning/attempting to become pregnant, not lactating; or commits to the use of an acceptable form of birth control for the duration of the study.
* Have a body mass index \<40 kg/m\^2

Exclusion Criteria:

* Have a known allergy or hypersensitivity to any study treatment.
* Planned surgical procedure includes a resection beyond the peritoneal reflection, is related to an acute bout of diverticulitis, or is associated with an emergency procedure.
* Have a history of myocardial infarction within the preceding 12 months.
* Have, as determined by the investigator or the sponsor's medical monitor, a history or clinical manifestations of significant condition that would preclude participation.
* Have active or recent (within 6 months) gastrointestinal ulceration or bleeding, with exception of events related to an ulcerative colitis diagnosis.
* Have a known bleeding disorder which may be worsened with the administration of an NSAID.
* Be currently receiving treatment with oral meloxicam (Mobic®) or another NSAID within 48 hours prior to surgery.
* Have previously received N1539/IV meloxicam or received any investigational product within 30 days before dosing with study medication.
* Have undergone or be expected to undergo radiation therapy, chemotherapy, or other biological therapy for cancer treatment, within 60 days prior to screening through last follow-up.
The Role of Computed Tomography in the Phenotyping of COPD Patients

Chronic obstructive pulmonary disease (COPD) is a common, preventable, and treatable disease that is characterized by respiratory symptoms and airflow limitation that is due to airway and/or alveolar abnormalities usually caused by significant exposure to noxious particles or gases. the CT was used for classification of COPD patients into different phenotypes: phenotype A that has minimal emphysema with or without airway disease, phenotype E that has emphysema without airway disease, and finally phenotype M as a mixed form. The investigators aimed to to identify the phenotypes of COPD using radiologic data obtained by computed tomography. Moreover, this study will be designed to answer the questions about possible correlation between pulmonary function parameters and CT.


Eligibility Criteria:
Inclusion Criteria:

* All stable COPD patients that lastly confirmed to have the disease based on spirometry and past clinical history according to GOLD (2022).
* Age above 18 years.

Exclusion Criteria:

* COPD patients associated with other chest diseases as collapse
* COPD patients associated with consolidation
* COPD patients unable to perform spirometry
Covid-19 Infection in Pregnancy

Prospective study of both maternal and fetal outcomes of those pregnancies that were complicated by COVID-19 infection at various gestational ages. The follow up will be from the time the diagnosis was made till discharge of the mother and her baby from the hospital.

Pregnancies that have a confirmed covid-19 infection by nasopharyngeal swab whether taken at our laboratory or confirmed at private or Ministry of health (MOH) laboratories will be followed up till delivery and discharge from the hospital.

They will be followed up for hospitalization, intensive care unit (ICU) admission, any complications (organ failure, DIC, renal failure, septic shock), intubation, mortality, miscarriage, congenital malformations, intra-uterine growth restriction (IUGR), oligohydramnios, spontaneous preterm birth, mode of delivery, birth weight, APGAR score at 1 and 5 minutes, neonatal infection with covid-19, neonatal ICU admission and breast feeding. Those patients will be followed up prospectively at our hospital and those with missed follow up and delivered outside our unit will be contacted to bring all the above-mentioned parameters. There will be no exclusion of cases.

Eligibility Criteria:
Inclusion Criteria:

* pregnant women

Exclusion Criteria:

* None
Cancer Survival Through Weight Loss and Exercise

To test the effectiveness and feasibility of intensive motivational, behavior modifying intervention aimed at improving physical activity and dietary habits to produce at least 7% weight loss in women with a history of breast cancer in a community health setting.

This study will be divided into two phases (Phase I and II) that will differ by the intensity of motivational intervention. In Phase I, participants will receive 6 months of intensive weekly group-based or telephone-based motivational, behavior modifying intervention aimed at improving physical activity levels and dietary habits. Phase II will be an additional 6 months of monthly individualized motivational intervention in order to attain and maintain at least 7% body weight loss. All participants will attend an orientation, 2 run-in sessions, and a baseline assessment prior to the intervention. Participants will then be assigned to either the group based intervention or telephone intervention. The first 30 participants will enter into the group-based intervention and the second 30 will enter into the telephone-based intervention. Follow-up visits will be completed at the end of Phase I (week 25) and Phase II (week 50). Up to 60 women with a previous history of breast cancer will participate in this study.

Eligibility Criteria:
Inclusion Criteria:

* Women between the ages of 30 and 75.
* Positive history of breast cancer treatment completed at least 2 months but no longer than 36 months prior to randomization.
* BMI ≥ 25 kg/m2 and ≤ 45 kg/m2
* Not involved in regular physical activity or weight loss management programs.
* Stage I, II or IIIa breast cancer with good prognosis.

Exclusion Criteria:

* Presence of any co-morbidities including cardiovascular disease or diabetes
* Fasting triglycerides \> 500 mg/dl.
* Consume more than 14 alcoholic beverages per week.
* A history of drug abuse, or excess alcohol consumption (40g/day)6.
* Currently dieting or engaging in any activity with the goal of losing weight.
* Significant intentional weight loss in the past year (\> 50 lbs in the past year) or current use of weight loss medications.
* History of gastrointestinal bypass or other bariatric surgery in the last 3 years.
* Pregnant or plan on becoming pregnant in the next 12 months.
* Factors that may limit adherence to intervention or affect conduct of the trial.
* Unable or unwilling to communicate with staff, to provide written informed consent, or accept the randomized assignment.
* Failure to complete run-in and baseline testing.
* Lack support from health care provider or family members.
* Other temporary intervening event, such as sick spouse, bereavement, or recent move.
* Any other medical condition or disease that is life threatening or that can interfere with or be aggravated by exercise.
* Current diagnosis of schizophrenia, other psychotic disorders, or bipolar disorder.
* Any other condition, which, in the opinion of the investigators would impede competence or compliance or possibly hinder completion of the study.
Safety Study of a Recombinant Protein Vaccine to Treat Esophageal Cancer

The purpose of this study is to determine the biological recommended dose of IMF-001.

The prognosis of esophageal cancer is improved with the improvement of surgery, chemotherapy and radiation therapy. However, there are no standard therapies established for recurrent esophageal cancer. NY-ESO-1 antigen is expressed in 33% of patients. NY-ESO-1 protein is applicable without limitation by HLA types, and injected as a complex with cholesteryl pullulan (CHP), forming nano-particles (IMF-001), it can activate both CD4+ and CD8+ T cells. In this phase 1 study, the safety and the biological recommended dose will be determined.

Eligibility Criteria:
Inclusion Criteria:

* Radically unresectable stage III/IV esophageal tumors that have failed the standard treatment (including chemotherapy and radiotherapy), recurrent metastasis after radical surgery and not responding to the standard treatments, or recurrent metastasis after radiotherapy before/after radical surgery.
* Primary esophageal tumors confirmed by pathological diagnosis
* Tumor cells expressing NY-ESO-1 antigen (by tissue-immunostaining method or quantitative RT-PCR method)
* Performance status (PS) of 0, 1 or 2 (ECOG Scale)
* Life expectancy \>/= 4 months
* No serious disorders with major organs (bone marrow, heart, lung, liver and kidney) and meets the following criteria:

  * WBC count \>/= 2.0 x 10 9/L
  * Hemoglobin \>/=8.0g/dL
  * Platelet count \>/=75 x 10 9/L
  * Serum total bilirubin: \</=1.5 x ULN (3 x ULN if with liver mets)
  * AST and ALT: \</=2.5 x ULN (5x ULN if with liver mets)
  * Serum creatinine: \</=1.5x ULN
* Agree to use birth control including condoms from the time of obtaining the consent to 6 months after the final administration of the study drug \[except females after menopause (1 year or more after the last menstruation and females/males after an operation for sterilization)\]
* Given written informed consent

Exclusion Criteria:

* HIV antibody positive
* Double cancer
* History of autoimmune disease
* History of severe anaphylaxis
* Active metastatic disease in the central nervous system (CNS) Within 4 weeks after treatment with an anti-tumor agent, systemically administered adrenocorticosteroids, immune suppressants or immune enhancers
* Pregnant or lactating
* Any other inadequacy for this study
The Effect of 12-Week Dietary Intake of Lutein on Minimal Erythema Dose and Other Skin Parameters

The double-center, randomized, placebo-controlled, one-period effectiveness study will include 30 subjects (women, aged between 25 to 55 years, Fitzpatrick phototype II and III). Subjects will be divided in two groups, 15 in each. One group (test group) will receive investigational product - lutein syrup (4 mg/mL; daily dose 20 mg) and the other (placebo group) placebo syrup. Participants will test continuous administration of placebo or investigational product for 12 weeks in order to demonstrate and assess multiple-dose effects. The primary objective is to assess the photoprotective potential of the investigational product in relation to placebo product. The secondary objectives are to assess effects of investigational product on dermis density and skin viscoelasticity after 12 weeks of dietary supplementation.


Eligibility Criteria:
Inclusion Criteria:

* Caucasian female volunteers aged between 25 and 55 years at the time of the signature of Informed consent form (ICF),
* Signed Informed consent form (ICF),
* Fitzpatrick skin phototypes II and III,
* No skin pigmentation disorders,
* In good health condition,
* Willingness to avoid a consumption of any food supplements containing carotenes or other antioxidants during the study,
* Willingness to avoid the sun, tanning beds and tanning products on the gluteal area during the study,
* Willingness to follow all study procedures and keeping a diary for during the study (to follow their compliance and palatability),
* No changes in dietary habits or dietary supplements in last month prior to inclusion.
* No changes in cosmetic facial and body care routine in last month prior to inclusion on measurement areas.

Exclusion Criteria:

* Pregnancy or breastfeeding,
* Known or suspected allergy to any ingredient of the tested products or UV radiation,
* Changes in dietary habits and dietary supplementation in last month prior to inclusion,
* Veganism,
* Changes in cosmetic facial and body care routine in last month prior to inclusion.
* Diagnosed and uncontrolled/untreated/unregulated disease,
* Any clinically significant history of serious metabolic disease, digestive tract disease, liver disease, kidney disease, haematological disease.
* Acute skin diseases,
* Regular consumption of food supplements containing carotenoids or other antioxidants in last month before inclusion into the study.
* Invasive rejuvenation treatments (e.g. needle rollers, needle mesotherapy, deep/medium-deep chemical peels etc.) in last 6 months prior to study entry,
* Non-invasive rejuvenation treatments (e.g. radiofrequency, electrotherapy, ultrasound therapy) in last 2 months prior to study entry,
* Gluteal hyperpigmentation,
* Mental incapacity that precludes adequate understanding or cooperation
Transcutaneous Spinal Cord Stimulation in Healthy Subjects to Activate Central Pattern Generator

The purpose of this study is to determinate whether the application of transcutaneous spinal cord stimulation produce changes in the excitability of alpha moto neurone in healthy volunteers. Moreover evidence whether the effect of the electric currents can increase muscle strength.

In the last years several experimental studies have evidenced that the transcutaneous spinal cord stimulation (tSCS) can evoque spinal reflex activity. The activation of propioceptive afferent would then activated motoneurons innervated at the same metameric and adjacent levels. The possibility of activating neural networks with non-invasive stimulation method opens a therapeutic window for the treatment of different neurological disorders. So the purpose of this study is quantify the modulation of the excitability of alpha motor neurone when the application of the current is in the central nervous system compared with a sham group.

Eligibility Criteria:
Inclusion Criteria:

* Participants will be volunteer healthy students of Physiotherapy, University of Castilla - La Mancha, older than 18 years.

Exclusion Criteria:

* Neuromuscular disease.
* Epilepsy.
* Trauma, surgery or pain affecting the upper limb, shoulder girdle or lumbar área.
* Osteosynthesis material in the upper limb.
* Diabetes.
* Cancer.
* Cardiovascular disease.
* Pacemaker or other implanted electrical device.
* Take any drug (NSAIDs, corticosteroids, antidepressants, analgesics, antiepileptics, ...) during the study and in the previous 7 days.
* Presence of tattoos or other external agent introduced into the treatment or assessment area.
* Pregnancy.
* Sensitivity disturbance in lower limb.
CD4 Cell Recovery in HIV-1 Patients Comparing 2 Treatment Regimes

Therapy guidelines recommend the use of either the non-nucleoside reverse transcriptase inhibitor (NNRTI) efavirenz or a ritonavir-boostered protease inhibitor (PI) plus 2 nucleoside reverse transcriptase inhibitors (NRTI) as first-line treatment regimes of HIV-1 infection. Recent clinical studies suggest potential advantages of NNRTI- over PI-based regimes in therapy initiation due to lower rates of virologic failure and less metabolic side-effects. In contrast, PI regimes were claimed to cause greater increases in CD4 cell count than NNRTI regimes, which has been attributed to intrinsic antiapoptotic effects of the PI. However, it is still unclear whether the immunological response to a PI-containing regime is greater than to an NNRTI-containing regime, whether there is a difference in the extent of reduction of apoptosis between PI and NNRTI regimes and whether a difference in apoptosis is associated with a difference in CD4 cell recovery.

We conducted a controlled, long-term, random matched pair design study in HIV-1 infected individuals under sustained virologic suppression to evaluate in head-to-head comparison the clinical effects of a constant PI-based or NNRTI-based regime on CD4 cell recovery and the underlying molecular, biochemical and functional mechanisms.


Eligibility Criteria:
Inclusion Criteria:

* Recent, non-acute HIV-1 infection
* Caucasians
* BMI between 17.5 and 30 kg/m2
* CD4 count \<200 cells/µl
* Plasma viral load \>100,000 HIV-1 RNA copies/ml

Exclusion Criteria:

* Actual or previous antiretroviral therapy
* Acute illness
* Coinfection with HBV or HCV
* Opportunistic infection (Pneumocystis jiroveci pneumonia, Toxoplasma gondii encephalitis, Mycobacterium ssp. infection, syphilis, cryptosporidiosis, cryptococcosis, aspergillosis, cytomegalovirus infection or progressive multifocal leukoencephalopathy)
* Hepatic or renal disorder
* Severe cardiovascular disease
* Hematologic disorder
* Autoimmune disorder
* Diabetes mellitus or other severe endocrine disorder
* Malignancy
* Neurocognitive disorder
* Psychiatric disorder
* Drug or alcohol addiction
* Chronic drug use (except of blood pressure-lowering or lipid-lowering drugs or proton-pump inhibitors)
* Any acute medication within 7 days or vaccination within 30 days prior to entry
* Pregnancy or lactation
A Trial to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of NNC0215-0384 Administered to Subjects With Moderate to Severe Rheumatoid Arthritis

This trial is conducted in Europe. The aim of the trial is to investigate the safety, tolerability, pharmacokinetics (exposure of the trial drug in the body) and pharmacodynamics (the effect of the investigated drug on the body) of NNC0215-0384 administered to subjects with moderate to severe rheumatoid arthritis (RA) concomitantly treated with methotrexate (MTX).


Eligibility Criteria:
Inclusion Criteria:

* Male or female, age between 18 and 75 years (both years inclusive), for Russia only: Age between 18-65 years (both years inclusive)
* Moderate to severe RA, confirmed by a Disease Activity Score based on 28 joints and C-reactive protein (DAS28 (CRP)) equal to or above 4.5 and a minimum of five tender and five swollen joints based on a 28 joint count (a joint can score as both tender and swollen)
* MTX (10-25 mg/week both inclusive) for at least 16 weeks, with an unchanged dose for at least 6 weeks prior to screening and until randomisation
* Females who are not of child-bearing potential must have been post-menopausal for at least 1 year confirmed by follicle-stimulating hormone (FSH) equal to or above 26.7 U/L or be surgically sterile

Exclusion Criteria:

* Past or current inflammatory joint disease other than RA (e.g. gout \[crystal proven\], psoriatic arthritis, juvenile idiopathic arthritis, reactive arthritis or Lyme disease
* Any active or ongoing chronic infectious disease (e.g. chronic osteomyelitis, chronic pyelonephritis) within 4 weeks prior to randomisation
* Clinically significant cardiac or cardiovascular disease
* Past or current malignancy
* Evaluation of tuberculosis screening indicative of latent or active tuberculosis (TB)
Transcutaneous Electrical Acupoint Stimulation on Postoperative Dizziness in Hemifacial Spasm Patients

To observe the prevention and treatment effect of transcutaneous electrical acupoint stimulation (TEAS) on postoperative dizziness in patients with hemifacial spasm undergoing microvascular decompression surgery, and its possible mechanisms.

Hemifacial spasm (HFS) is mainly caused by vascular compression on the roots of the VII cranial nerves from the brain stem. Microvascular decompression (MVD) is the exact surgical method for the treatment of HFS, but the incidence of dizziness and postoperative nausea and vomiting (PONV) after MVD is extremely high. Despite the use of dual antiemetic therapy during the operation, the incidence of PONV within 24 hours after MVD is still as high as 66.7%. Medication alone has limited effects on dizziness and PONV treatment after MVD. Meta-analysis shows that transcutaneous electrical acupoint stimulation (TEAS) is associated with the reduction of post-emetic remedies and the incidence of dizziness after general anesthesia, and it can be integrated into the multi-modal therapy of PONV. Therefore, the purpose of our study is to observe the prevention and treatment effect of TEAS on postoperative dizziness in patients with hemifacial spasm undergoing microvascular decompression surgery, and explore its possible mechanisms.

Eligibility Criteria:
Inclusion Criteria:

* American Society of Anesthesiologists (ASA) physical status: I-III
* Body mass index (BMI): 18-30
* Diagnosed of hemifacial spasm
* Undergoing microvascular decompression surgery

Exclusion Criteria:

* Pregnant or lactating women
* Poorly controlled hypertension or poorly controlled diabetes, severe cardiovascular and cerebrovascular diseases and mental illness
* Cardiac pacemakers
* Scars on bilateral Neiguan acupoints or on the mastoid area
* Upper limb nerve injury
* Raynaud's syndrome
* Motion sickness or PONV history
* Eye diseases (glaucoma, cataracts, eye trauma, etc.) or previous eye surgery
* Participate in other clinical trials