cyrilzakka/clinical-trials huggingface dataset:
Oral Camostat Compared With Standard Supportive Care in Mild-Moderate COVID-19 Patients

This study will evaluate the efficacy of oral Foipan® (camostat mesilate) compared with the current standard of care in reducing the duration of viral shedding of SARS-CoV-2 virus in patients with mild-moderate COVID-19 disease.

Patients will attend 4 study visits over a period of up to 28 days.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of COVID-19 disease as presence of mild-moderate symptoms without signs of respiratory distress, with FDA-cleared molecular diagnostic assay positive for SARS-CoV-2 within 72 hours prior to informed consent
* Males must be sterile, OR agree not to donate semen AND agree to strictly adhere to contraceptive measures during the study and for seven days following the last dose of study medication
* Females must be unable to bear children, OR ensure that their male partner is incapable of fathering a child, OR, if of childbearing potential will strictly adhere to contraceptive measures during the study and for seven days following the last dose of study medication
* Females must agree to stop breast-feeding prior to first dose of study drug and through seven days after completing therapy
* Females must have a negative pregnancy test at screening
* Participant agrees to maintain home or other quarantine as recommended by the study physician, except to visit the study site as required by the protocol

Exclusion Criteria:

* Concomitant bacterial respiratory infection documented by respiratory culture. NOTE: Subjects on empirical antibiotic treatment for possible but unproven bacterial pneumonia, but who are positive for SARS-CoV-2, are allowed in the study.
* Previous use of antiviral drugs that may be active against Covid-19.
* Abnormal laboratory test results at screening:
* Use of adrenocorticosteroids (except topical or inhaled preparations or oral preparations equivalent to or less than 10 mg of oral prednisone) or immunosuppressive or immunomodulatory drugs (e.g., immunosuppressants, anticancer drugs, interleukins, interleukin antagonists or interleukin receptor blockers). NOTE: Treatment of study participants following institutional COVID-19 treatment policies or guidelines, including the use of immunomodulatory medications, is permitted. This excludes treatment with agents that have the potential for direct antiviral activity, including convalescent plasma and NO, and co-enrollment into other clinical studies that evaluate investigational agents for COVID-19.
* Serious chronic disease (e.g., human immunodeficiency virus \[HIV\], cancer requiring chemotherapy within the preceding 6 months, and/or moderate or severe hepatic insufficiency).
* Previously received camostat mesilate within the past 30 days.
* Advanced kidney disease
* Advanced liver disease
* History of alcohol or drug abuse in the previous 6 months.
* Psychiatric illness that is not well controlled (defined as stable on a regimen for more than one year).
* Taken another investigational drug within the past 30 days.
* Seemed by the Investigator to be ineligible for any reason.
Effectiveness of Thyme Honey in Management of Xerostomia in Post Radiation Cancer Patients

Xerostomia is the most frequent complication among patients who receive radiotherapy (RT) . The prevalence of xerostomia has been reported to be from 73.5% to 93% (Kakoei S.,2012). Damage to normal tissues can result by radiotherapy as it is not selective to cancer cells, and so affecting the quality of life of patients. Honey is one of the methods studied by CIM for management of HNC treatment side effects due to its properties. (Brennan et al., 2002; Clarkson et al., 2007; Furness et al., 2011;Hackett et al., 2015).

Thyme honey is a new alternative for management of xerostomia, which is a propolis gel product. Thyme honey is a variety of monofloral honey made from the nectar and pollen of thyme flowers. It has a strong antioxidant, antibacterial, antifungal and immuno modulating health effects. Due to the high sugar concentration in honey, it is believed that its presence in the oral cavity has a sialogogue effect, stimulating the salivary glands to produce saliva.

28 post radiation cancer patients were randomly assigned into two equal groups.The intervention group will have oral rinses (20 ml of thyme honey diluted in 100 ml of purified water) 3 times per day starting in the 4th week of radiotherapy and for one month after completion of radiotherapy. Patients in the control arm followed the same protocol with normal saline rinses. The treatment assessment of subjective dry mouth score, objective dry mouth score, salivary Ph and salivary flow rate will be carried out at baseline, 2 weeks and one month after starting of the treatment protocol (Charalambous et al., 2017).

Nitric oxide levels will be measured at baseline and after one month of treatment (Abadi et al., 2020).

Eligibility Criteria:
Inclusion Criteria:

* Patients referred to non-palliative head and neck radiotherapy
* Total dose of radiation received (50-70 Gy)
* Patients with complaint of xerostomia
* Age 25-65 years old
* Objective dry mouth score from ( 2-5)
* Subjective dry mouth score from (1-4)
* Undergoing radiotherapy for at least three weeks
* Can independently complete the questionnaire

Exclusion Criteria:

* Have confirmed systemic diseases or medications associated with xerostomia
* Have a known allergy to honey
* Patients who had salivary glands removal surgery
* Patients with salivary gland diseases or malignancy
* Vulnerable groups such as pregnant females, prisoners, mentally and physically handicapped individuals.
Yoga for Physical and Mental Health

In the university environment, where academic pressure and personal exploration are paramount, yoga serves as a sanctuary for students facing stress and seeking self-discovery. Through practices like asanas, pranayama, and meditation, yoga equips students with tools to manage stress, foster inner balance, and enhance emotional well-being. Apart from its emotional benefits, yoga offers physical advantages, improving strength, flexibility, and posture, particularly beneficial for those sedentary due to academic demands. Moreover, yoga enhances concentration and mental clarity through mindfulness practices, aiding students in academic focus and problem-solving.Additionally, yoga provides a space for students to disconnect from external stimuli and recharge, reducing mental and physical fatigue while boosting vitality. By integrating yoga into university life, students can better balance academic pressures with personal care, laying the groundwork for a more harmonious and mindful future.


Eligibility Criteria:
Inclusion Criteria:

* University students who do not participate in any physical exercise program
* Sufficient physical autonomy to participate in the physical activities required by the study
* That they are able to understand the instructions, programs and protocols of this project.

Exclusion Criteria:- University students who have serious physical or mental conditions

* Lack of commitment to regular attendance
* Extensive previous experience in yoga
Anaesthesia and Apoptosis

Anesthetics cause widespread apoptosis in the developing brain, resulting in neurocognitive abnormalities. However, it is unknown whether anesthesia-induced neurotoxicity occurs in humans because there is currently no modality to assess for neuronal apoptosis in vivo


Eligibility Criteria:
Inclusion Criteria:

* congenital heart corrective surgery

Exclusion Criteria:

* none
Unrelated Double Umbilical Cord Blood Units Transplantation

The purpose of this study is to determine the safety and feasibility of unrelated double umbilical cord blood units Transplantation in patients with haematological malignancies using Antithymocyte Globulin Cyclophosphamide, busulfan as conditioning and cyclosporin, methylprednisolone as GVHD prophylaxis.


Eligibility Criteria:
Inclusion Criteria:

* Hematologically \& Histologically confirmed acute lymphoblastic or acute and chronic myeloid leukemia in Remission
* Aged 1 year to 50 years
* Absence of HLA compatible related or other related donor.
* Availability of suitable UCB units.
* karnofsky performance score (\> 12 yr) or lansky play performance(\<12 yr) : 80- 100
* Adequate renal function defined as:Serum creatinine \<1.5 x normal,
* Adequate liver function defined as:Total bilirubin \<1.5 x normal, or SGOT (AST) or SGPT (ALT) \<3.0 x normal
* Adequate cardiac function defined as: Ejection fraction \>50% by echocardiogram.
* Adequate pulmonary function defined as:Uncorrected DLCO 50% by pulmonary function test.For children who are uncooperative, no evidence of dyspnea at rest, no exercise intolerance, and a pulse oximetry \>94% on room air

Exclusion Criteria:

* Age: \< 1year or \> 50 year
* Patients with an available 5-6/6 HLA-A, -B, -DRB1 matched sibling or other related donor
* karnofsky performance score (\> 12 yr) or lansky play performance(\<12 yr) \< 80
* HIV positive patients.
* Female patients who are pregnant or breast feeding
* Life expectancy severely limited by diseases of vital organs other than the disease indication for transplant
* Serious concurrent untreated infection e.g. active tuberculosis, mycoses or viral infection
* Serious psychiatric/ psychological disorders
* Absence of /inability to provide informed consent
* Clinical or Paraclinical evidence of CNS or PNS involvement
QOL & Functional Outcomes After Combined Modality Tx for Anal CA: Comparison of Conventional vs IMRT

The purpose of this study is show that intensity-modulated radiotherapy (IMRT), as compared with conventional radiotherapy, improves the precision of tumor targeting and reduces the acute and late effects of radiation toxicity when used to treat anal cancer. Results from this work will provide a basis for incorporating the use of IMRT to treat anal cancer in future treatment protocols.

The objectives of this study are three-fold. First, we would like to learn and compare the doses of radiation received by the tumor and the normal tissues in anal cancer patients treated with IMRT, and in those treated with conventional radiotherapy. Second, we wish to compare the acute effects of radiation treatment in both groups of patients. Our third objective is to evaluate the late effects of radiation treatment in both groups of patients. The first two objectives will be studied using a retrospective analysis of patients with anal cancer treated at Stanford University Medical Center. The third objective will require these patients to complete and return three quality of life questionnaires.

Eligibility Criteria:
Inclusion Criteria:Histologically confirmed diagnosis of squamous cell carcinoma of the anus. Must be able to provide informed consent. Exclusion Criteria:History of new malignancy since the time of treatment for anal cancer. Non-English speaking.
European Disease Registry on Retinopathy of Prematurity (ROP)

The EU-ROP registry is a European wide multicenter non-interventional observational registry study intended to run open-ended in as many countries as possible including infants treated for retinopathy of prematurity irrespective of the used treatment modality. The registry is strictly observational; only clinical routine data is collected, no study-specific examinations or interventions are to be performed.

The aim of the EU-ROP registry is to collect information on as many patients as possible treated for ROP in Europe. Both the number of study centers as well as the number of patients to be included into the registry are not limited.

The primary objective is to describe the typical clinical features of infants with severe ROP, variations in phenotype, and the clinical progression of the disease over time (natural history) in different European countries as well as to study treatment patterns, follow-up patterns, as well as long-term outcomes.


Eligibility Criteria:
Inclusion Criteria:

* ROP requiring treatment according to the respective national ROP screening and treatment guidelines

Exclusion Criteria:

* Denial or absence of consent for documentation and electronic storage of personal data by parents or legal guardians
The Use of Dantrolene to Improve Analgesia in Posterior Lumbar Surgery

The purpose of this study is to determine whether administration of a non-centrally acting muscle relaxants will improve the Overall Benefit of Analgesia Score (OBAS), and Richmond Agitation Sedation Scale (RASS) scores in patients undergoing lumbar fusion.


Eligibility Criteria:
Inclusion Criteria

* 18 - 80 years of age (inclusive)
* Presenting to the study hospital for lumbar decompression and/or fusion (instrumented fusion of the lumbar spine \< 4 levels) under general anesthesia, and scheduled for same-day admission or in-patient admission
* American Society of Anesthesiologists (ASA) Category 1, 2 or 3

Exclusion Criteria

* Known allergy to Dantrolene, morphine or other opioids, benzodiazepines that causes a reaction of hives, anaphylaxis, shock, unconsciousness/fainting, rashes/blisters, irregular heartbeat, fever, swelling, shortness of breath, wheezing, serum sickness, drug induced anemia, drug reaction with eosinophilia, and systemic symptoms, or nephritis
* Oxygen saturation \< 94%
* Patient being treated with any of the following medications:Non-dihydropyridine Calcium Channel Blockers including verapamil, Estrogen therapy
* Current or past medical history of any of the following: hepatic impairment (including history of transplant), renal impairment or chronic renal disease (including history of transplant), chronic alcohol abuse, chronic respiratory disease (i.e. chronic hypoxia or hypercapnia, COPD)
* Recent history of aspiration (within the last 3 months)
* Patients with any history of neuromuscular dysfunction
* History of obstructive sleep apnea
* Weight \> 140 kg
* Currently pregnant
* Actively breastfeeding
* Inability to provide written informed consent
Pectoral Nerve Block Versus Paravertebral Block In The Incidence of Chronic Pain After Mastectomy:

Chronic pain after Mastectomy is frequent and an important healthcare priority because of its effect on quality of life. Although the association between the severity of acute pain after surgery and the likelihood of chronic pain is known, their causal relationship has not been clarified. Mastectomy, frequently done for the management of breast cancer, is associated with significant acute postoperative pain and limited shoulder movement.

General anesthesia with postoperative NSAI D and opioids is a commonly used technique for postoperative analgesia after breast surgeries. Patients with mastectomy under general anesthesia commonly have pain in the axilla and upper limb that increases hospital stay, costs, and postoperative complications .Thoracic paravertebral block can be performed for analgesia after breast surgery. Ultrasound usage gave an accurate reading of the depth to the paravertebral space and can be used during the whole technique. Breast surgery is usually done with axillary dissection and can be done at single or multiple levels of thoracic paravertebral blocks .Thoracic paravertebral block is associated with multiple complications such as hypotension, pneumothorax, sympathetic block, central spread of local anesthesia or failed block which may cause limitations in the technique. The use of ultrasound in anesthesia increases the success rate of the block and decreases the incidence of variable complications .On the other hand, many interfascial plane blocks have been described. Pectoral nerve block (PECS) has been described as interfascial plane blocks and provide analgesic adjuvants for breast surgery with or without axillary dissection. The block was described as an injection of local anesthetic between the pectoralis major and minor muscles (PEC I) and between pectoralis minor and serratus anterior muscle (PEC 2) .

Eligibility Criteria:
Inclusion Criteria:

* ASA grade I, II, or III female patients in the age group of 20-65 years
* with body mass index (BMI) of 25-35 who were undergoing mastectomy with or without axillary lymph node or sentinel lymph node dissection or partial mastectomy (sparing the skin, areola, and nipple) with axillary lymph node dissection

Exclusion Criteria:

* male sex; patient refusal,
* a life expectancy less than 2 yr;
* active malignant disease; pregnant or breastfeeding women;
* bilateral surgery; ipsilateral breast surgery in the past 3 yr;
Analgesic Efficacy And Safety of Tanezumab Added On To Diclofenac SR In Patients With Osteoarthritis Of The Knee Or Hip

The purpose of this study is to investigate the analgesic efficacy and safety of tanezumab added on to diclofenac SR in patients with osteoarthritis of the knee or hip currently experiencing partial benefit from, and are tolerating, diclofenac 150 mg/day therapy.

This study was terminated on 16 Nov 2010 following a US FDA clinical hold for tanezumab osteoarthritis clinical studies which halted dosing and enrollment of patients on 23 June 2010 for potential safety issues.

Eligibility Criteria:
Inclusion Criteria:

* Osteoarthritis of the knee or hip according to ACR criteria with Kellgren-Lawrence X-ray grade equal to, or greater than, 2.
* Patients must be experiencing some benefit from their current stable dose regimen of oral diclofenac 150 mg/day and be tolerating their diclofenac regimen.
* Pain and function levels as required by the protocol at Screening and Baseline.
* Willing to discontinue all non-study pain medications throughout the study except as permitted per protocol.
* Willing and able to comply with lifestyle guidelines, scheduled visits, treatment plan, laboratory tests and other study procedures.

Exclusion Criteria:

* Pregnant women.
* BMI greater than 39.
* History of other disease that may involve index knee or hip including inflammatory joint diseases, chrystalline disease (gout or pseudogout), endocrinopathies, metabolic joint diseases, lupus erythematosus, rheumatoid arthritis (RA), joint infections, neuropathic disorders, avascular necrosis, Paget's disease or tumors.
* Fibromyalgia, regional pain caused by lumbar or cervical compression with radiculopathy or other moderate to severe pain that may confound assessments or self-evaluation of the pain associated with OA.
* Signs and symptoms of clinically significant cardiac disease within 6 months prior to screening.
* Diagnosis or TIA within 6 months prior to screening or diagnosis of stroke with residual deficits that would preclude completion of required study activities.
* History, diagnosis , signs or symptoms of clinically significant neurological and/or psychiatric disease/disorder.
* At Screening: uncontrolled hypertension, hemoglobin A1c greater than or equal to 10%, ALT or AST greater than or equal to 3X upper limit of normal, creatinine exceeding 150 micro-mol/L in men or 133 micro-mol/L in women.
* Patients on warfarin or other coumadin anticoagulant therapy and/or lithium therapy within 30 days prior to Screening.
* Known hypersensitivity to NSAIDs (eg, diclofenac), cyclooxygenase inhibitors or paracetamol (acetaminophen).
Brachiocephalic Arteriovenous Fistulae: Two Different Techniques of Bloodless Surgery and Their Effect on Fistula Stenosis.

Patients with a chronic kidney disease who opt for hemodialysis, needs a well-functioning hemodialysis access. The autologous arteriovenous fistula (AVF) is recognized as the golden standard of dialysis access. Unfortunately a great number of the AVFs fail to mature, and therefore cannot be used for dialysis. A significant stenosis is a major cause of nonmaturing AVFs. Remarkable are the stenoses that seem to develop in the venous outflow tract where the vascular clamp was located during surgery. The primary aim of this study was to compare bloodless surgery using vascular clamps and a tourniquet with respect to the development of hemodynamic or anatomical significant stenosis in patients with a brachiocephalic or radiocephalic AVF.

Patients with a chronic kidney disease who opt for hemodialysis, needs a well-functioning hemodialysis access. The autologous arteriovenous fistula (AVF) is the golden standard of dialysis access. Unfortunately a great number of the AVFs fail to mature, and therefore cannot be used for dialysis. A significant stenosis is a major cause of nonmaturing AVFs.

Remarkable are the stenoses that seem to develop in the venous outflow tract where the vascular clamp was located during surgery. The primary aim of this study was to compare bloodless surgery using vascular clamps and a tourniquet with respect to the development of hemodynamic or anatomical significant stenosis in patients with a brachiocephalic or radiocephalic AVF.

Eligibility Criteria:
Inclusion Criteria:

* Mentally competent
* Written informed consent
* Age 18 years and older
* Indication for brachiocephalic AVF in HagaZiekenhuis
* Patient is able to complete the follow-up evaluation

Exclusion Criteria:

* Pregnancy
Evaluating the Saving Babies Lives Care Bundle Version 2

The purpose of this study is to learn about the implementation of NHS England's Saving Babies Lives Care Bundle Version 2 to reduce perinatal mortality.

It will explore whether the care bundle is effective at reducing stillbirth rates, neonatal death rates and preterm births in England. It will also explore the lived experiences of women's maternity care and their babies neonatal care, and the views and experiences of healthcare professionals who are involved in delivering the care bundle.

The main questions it aims to answer are:

* Does the care bundle reduce perinatal mortality rates?
* What are women's views and experiences of their maternity and neonatal care?
* What are the barriers around delivering the care bundle and how can this be improved?
* How do health inequalities affect the care women receive?
* How does the workforce culture affect how healthcare professionals use the care bundle?

Perinatal mortality rates and other pregnancy outcomes will be obtained from national data sources. Women and healthcare professionals will be asked to complete a survey and we will interview select groups of participants to further explore their experiences.

Mortality rates will be compared before and after the implementationof the care bundle where data allows. Data from the surveys will be descriptive. Data from the interviews will be analysed using thematic analysis to determine patterns and recurring ideas in the data.

In April 2022, NHS England commissioned the University of Manchester to conduct an independent evaluation of the effectiveness of the Saving Babies' Lives Care Bundle Version 2 (SBLCBv2) on reducing perinatal mortality in England. The study was commissioned in two phases.

Phase 1 comprises a national (service) evaluation of the impact of the SBLCBv2 on perinatal mortality rates, associated clinical outcomes, and any unintended consequences using routine data derived from national databases. Phase 2 comprises a qualitative evaluation to further understand the impact on maternity services, women and their families.

Phase 2 will be conducted in a cohort of maternity units across England using a mixed-methods approach. The views and experiences of women and healthcare professionals towards maternity care in relation to the SBLCBv2 will be sought using surveys and interviews. Additionally, this study will interview organisational leads to assess how resources, leadership and governance may affect implementation in diverse hospital settings.

Eligibility Criteria:
Phase 1:

All births in England.

Phase 2:

Inclusion Criteria:

* women who have given birth in the last 12 months
* women who can understand English
* healthcare professionals involved in delivering the care bundle

Exclusion Criteria:

* women who gave birth more than 12 months ago
* women who cannot understand English
* women without access to the internet for online survey completion
* healthcare professionals not involved in delivering the care bundle