cyrilzakka/clinical-trials huggingface dataset:
Special Care Patterns for Elderly HNSCC Patients Undergoing Radiotherapy

The number of elderly head-and-neck squamous cell carcinoma (HNSCC) patients is increasing; however, the evidence regarding the ideal treatment for this often vulnerable and frail patient cohort is limited. Although the benefit of concomitant chemotherapy has been reported to decrease in elderly HNSCC patients based on the MACH-NC meta-analysis, it remains unknown whether state-of-the art radiotherapy techniques such as intensity-modulated radiotherapy (IMRT), modern supportive treatments and alternative chemotherapy fractionation (e.g., cisplatin weekly) may have altered this observation. The objective of this retrospective multinational multicenter study is to determine the oncological outcomes of elderly patients (≥65 years) with locally advanced HNSCCs undergoing definitive (chemo-)radiation and to investigate the influence of concomitant chemotherapy on overall survival and progression-free survival after adjusting for potential confounder variables such as age, performance status and comorbidity burden.


Eligibility Criteria:
Inclusion Criteria:

* definitive (chemo-)radiotherapy of locoregionally advanced (cT3-4 and/or cN+) head-and-neck squamous cell carcinomas (HNSCC) of the oral cavity, oropharynx, hypopharynx or larynx
* primary treatment since 2005
* age ≥65 years at the time of (chemo-)radiotherapy

Exclusion Criteria:

* adjuvant (chemo-)radiotherapy
* history of previous head-and-neck cancers or radiotherapy in the head-and-neck region
* distant metastases at (chemo-)radiotherapy initiation (cM1)
* HNSCCs of the nasopharynx, salivary glands, skin or with unknown primary
Epithelium-on Cross-linking Versus Observation of Fellow Eyes of Patients With Unilateral Clinically Evident Keratoconus

Keratoconus (KC) is a bilateral asymmetric progressive corneal degenerative disease. The management of young patients, diagnosed with clinically evident KC in one eye and with no clinical signs of KC in the other eye, represents a real challenge for many ophthalmologists.

The aim of the current study is to investigate the effectiveness and safety of epithelium-on accelerated CXL to stabilize the eye with no clinical signs of KC, in young patients with unilateral clinically evident KC, compared with standard care and follow-up only.

Keratoconus (KC) is a bilateral asymmetric progressive corneal degenerative disease associated with corneal thinning and protrusion with resultant irregular astigmatism and visual loss.

Although several studies showed that epithelium-off corneal cross-linking (epi-off CXL) is more effective in preventing KC progression compared with epithelium-on corneal cross-linking (epi-on CXL), the removal of corneal epithelium in epi-off CXL might be associated with a number of serious complications such as persistent epithelial defects and sight-threatening infectious keratitis. Additionally, recent systematic reviews and meta-analysis concluded that epi-on CXL is as effective as epi-off CXL in terms of visual and topographic stability of keratoconus, but has the advantage of being much safer avoiding the complications of epithelial removal.

The management of the better eye, of young patients with unilateral clinically evident KC, is controversial. Some ophthalmologists prefer to cross-link the better eye, while others prefer to conservatively follow it up, in order to avoid complications of epithelial removal in epi-off CXL.

Eligibility Criteria:
Inclusion Criteria:

Patients aged 12 to 30 years presented with forme fruste (FFKC) or subclinical KC, based on the following criteria:

1. Normal slit lamp examination
2. Normal topography in FFKC and suspicious topography in subclinical KC with asymmetric bow-tie or inferior steeping (inferior-superior value less than 1.40 D in the anterior sagittal curvature map in pentacam)
3. Clinical and topographic features of KC in the other eye.

Exclusion Criteria:

1. Corrected distance visual acuity (CDVA) worse than 0.1 logMAR
2. Corneal thickness at the thinnest location less than 400 μm
3. Severe ocular allergy (active catarrhal keratoconjunctivitis)
4. Other corneal or ocular diseases
5. Systemic diseases such as diabetes mellitus and autoimmune diseases
SMS-based Mobile Health Intervention for Nutritional Status and Treatment Outcome Among TB Patients

Ethiopia is one of the high burden Tuberculosis countries and Tuberculosis is still the leading cause of mortality due to communicable diseases in the country. Nutritional status is one of the predictors of TB treatment outcomes. Thus, the current practices need integration of nutritional intervention in the DOT using Mobile health intervention. However, to investigator's knowledge, there is no sufficient evidence on the effect SMS text Messaging Mobile Health intervention on nutritional status and TB treatment outcomes in Ethiopia.

To ensure the quality of SMS intervention, nutritional related SMS text message will be developed systematically through reviewing literature, systematic reviews and guidelines and appropriate behavioral theories by involving experts and patients. Automated SMS will be sent from one computer database at the scheduled date and time. A validated questionnaire will be adapted and pre-tested to check for any error. Adequate sample size is calculated for both arms with the ratio of 1:1 allocation. Standardized Anthropometric measurement, FANTA Household Dietary Diversity Score and WHO TB treatment outcome classification will be used for assessing the outcome variables. The data collectors will be trained on the objective, screening of eligible participants, the procedure of data collection, and how to assure the quality and security of the data based on the protocol. Continuous supervision will be employed throughout the data collection and intervention period. The data will be collected electronically and will be exported to STATA for analysis. Intention to treat analysis and regression analysis model will be employed.

Eligibility Criteria:
Inclusion Criteria:

* Patient who is following their anti TB treatment for at most two weeks and below
* Patient who have their own mobile phone
* Patient who is able to read and understand national official language (Amharic)

Exclusion Criteria:

* Patient whose TB treatment regimen more than 6 months
* Patient who is pregnant and lactating mothers
* Patient who enrolled other Interventional research
Purge Vs no Purge in Living Donor Liver Transplantation Recipients

The investigators tested the impact of purging the graft contents and mesenteric blood into the systemic circulation versus washing out this volume out of the circulation in living donor liver transplantation recipients.

All donors had right hepatectomy. On the back table, surgeons flushed liver grafts with 4 Liters of cold Custodiol solution. Patients were randomized into either purge group (Pg) (n=40) were graft fluid contents were washed out by the patient's portal vein blood (0.5ml per gram graft weight) through incompletely anastomosed hepatic vein, or No purge group (NPg) (n=40) where graft fluid contents were washed into the systemic circulation by the patient's portal blood. The primary outcome objective was the mean arterial blood pressure 5 minutes after portal declamping. Secondary objectives included hemodynamic and oxygenation.

Eligibility Criteria:
Inclusion Criteria:

* Adult living donor liver transplantation recipients of either sex in mansoura liver transplantation program

Exclusion Criteria:

* re-transplantation
* Previous upper abdominal operation
* Budd Chiari syndrome
MRI Review of Tracheal Dimensions

To date, there have been no published reports of normal variations in tracheal dimensions for pediatric patients undergoing MRIs. While there are reports of normals in CT studies, the reported dimensions were for average areas and lengths over the entire length of the trachea and not for normal variation in the dimensions at various sites in the trachea. Moreover, CT measurements are likely not entirely applicable to MRI measurements. Since cardiac MRI has become the procedure of choice to document the presence of vascular rings as well as the significance of any ring that is found, there is a need for normal values to be generated. This would in turn permit physicians to determine in cases of documented vascular rings the severity of the tracheal stenosis/deformity if found.

To date, there have been no published reports of normal variations in tracheal dimensions for pediatric patients undergoing MRIs. While there are reports of normals in CT studies, the reported dimensions were for average areas and lengths over the entire length of the trachea and not for normal variation in the dimensions at various sites in the trachea. Moreover, CT measurements are likely not entirely applicable to MRI measurements. Since cardiac MRI has become the procedure of choice to document the presence of vascular rings as well as the significance of any ring that is found, there is a need for normal values to be generated. This would in turn permit physicians to determine in cases of documented vascular rings the severity of the tracheal stenosis/deformity if found.

Hypothesis: Patients referred for cardiac MRIs to evaluate vascular rings will have significantly smaller tracheal dimensions (area, longest width, shortest width) based on a percentage of their maximal tracheal dimension in comparison with patients referred for cardiac MRIs for other indications.

I would propose to retrospectively review cardiac MRIs for tracheal dimensions in 25 consecutive patients referred for possible vascular rings and for 50 consecutive patients undergoing cardiac MRIs for other indications. As part of this study I would also propose to review the clinical findings that prompted the cardiac MRI to be ordered (i.e. respiratory symptoms, abnormal echocardiogram, abnormal CXR or barium swallow).

Eligibility Criteria:
Inclusion Criteria:

* 25 consecutive patients referred for possible vascular rings 50 consecutive patients undergoing cardiac MRIs for other indications adequate axial double-inversion recovery images of sufficient quality to permit accurate measurement of variations in tracheal dimension.

Exclusion Criteria:

* Those who do not meet inclusion criteria
Dysphagia Evaluation After Stroke- Effect Oral Neuromuscular Training on Swallowing Dysfunction

The aim of this study is to investigate the effect of a specific rehabilitation program with an oral device used in stroke patients with persistent oral-and pharyngeal dysphagia.

This study aims to investigate the effect of oral neuromuscular training in stroke patients with persistent oral- and pharyngeal dysphagia 12 (±3) weeks after stroke onset.

Interventional study with PROBE-design (prospective randomized open-label blinded evaluator). Consecutive patients with first-ever stroke without previously known dysphagia with persistent dysphagia (DOSS\<6) at 3 months (12±3 weeks) post-stroke onset. Patients are eligible to participate if they are admitted to one of the following seven hospitals/centers in Sweden: Umeå University Hospital, Danderyds Hospital, Södersjukhuset, Skaraborg Hospital (Skövde), Helsingborg Hospital, Halland Hospital, Kungälv Hospital, Kalix Hospital, Skellefteå Hospital, and Ellenbogen in Malmö. Further centers will be recruited. Exclusion criteria: Unable/unwilling to give informed consent or to cooperate.

Randomization will be made web-based 1:1 by use of the developed REDCap system with stratification for center and aspiration (yes/no).

In total, 336 stroke patients (168 intervention group; 168 control group) with persistent dysphagia 12(±3) weeks after stroke onset will be included in the present study. The intervention group will be offered to undergo oral neuromuscular training alongside routine care with compensatory training for 3 months. The control group will only be offered routine care with compensatory training for 3 months.

The participants' status regarding swallowing function, nutritional status, quality of life related to swallowing, pneumonia, functional status including lip force, and death will be assessed before and after the completed intervention period, and 6 months post-intervention.

The primary endpoint will be analyzed using an ordinal regression (proportional odds) model, adjusting for baseline DOSS as well as for the stratifying variables center and aspiration.

The investigators hypothesize that swallowing intervention with oral neuromuscular training is more effective than routine care rehabilitation.

Eligibility Criteria:
Inclusion Criteria:

* Persistent dysphagia 12(±3) weeks after STROKE.

Exclusion Criteria:

* Stroke patients with neurologic or psychiatric disorders or other diseases/conditions that can affect swallowing function.
* Unable to collaborate due to other serious diseases and/or to affected general condition.
Green Tea, High in Epigallocatechin Gallate (EGCG) and Postprandial Fat Oxidation

The body of evidence regarding the health benefits of green tea has grown considerably during the last decade and includes antioxidant properties, anti- cancer, anti-obesity and anti-diabetes effects. There has been evidence that green tea extract favorably affect body weight and body fat and has positive effects on blood glucose control

Aim of this study is to investigate the short term effect (3-day)of TEAVIGO (high in the catechin EGCG) on postprandial fat oxidation during different phases of the postprandial period in overweight subjects. Secondly, in a subset of volunteers changes in lipolysis and glucose metabolism will be studied in skeletal muscle and adipose tissue.


Eligibility Criteria:
Inclusion Criteria:

* Age between 20 and 50 y
* BMI 25.0-29.9 kg/m2
* Normal fasting glucose \<6.1 mmol/L
* Blood pressure (systolic blood pressure 100-150 mmHg, diastolic blood pressure 60-90 mmHg)
* Weight stable in last 3 months (±2 kg)

Exclusion Criteria:

* pregnant, lactating or (post)menopausal women
* regular smokers
* people with intensive fitness training eg athletes
* habitual consumption of green or black tea (more than 1 or 2 cups a day, respectively)
* not more than 300 mg/day caffeine consumption
Morbidity Related to Secondary Hyperparathyroidism After Renal Transplantation

The purpose of the study is to evaluate the long term vascular morbidity and mortality in kidney transplant recipients based on one year post transplant levels of intact parathyroid hormone.

Secondary hyperparathyroidism (SHPT) is a well known complication to chronic renal failure. With impaired renal function the phosphate excretion from the kidney is reduced. Together with low levels of 25- and 1,25-vitamin D3 and hypocalcemia this uremic mineral milieu drives the release of parathyroid hormone (PTH) and the development of SHPT. PTH has many functions but acts mainly to release calcium from the skeleton, to enhance calcium uptake from the intestines (by actions on vitamin D) and to lower serum phosphate by inducing phosphaturia. SHPT has been shown to cause vascular morbidity and fractures in the chronic kidney disease (CKD) patient. After successful renal transplantation (RT) the mineral disturbances are mostly recovered and stabilized at one year post RT, but in recent years it has been shown that SHPT persists in the major part of RT-recipients even after long term follow up. This has been associated with high risk of fractures and vascular related morbidity in the post transplant period. It has also been shown that low levels of iPTH in the post-transplant period might be associated with a high risk of fractures. Because of insufficient data on PTH levels and associated morbidity there is no specific recommendations of target PTH levels in the RT-patient. This indicates that there is need for further observational studies to describe the SHPT-associated morbidity in a post transplant cohort based on stabilized levels of post transplant iPTH.

Eligibility Criteria:
Inclusion Criteria:

* Between 18-85 years at date of transplantation
* Signed informed consent or deceased at time of data collection

Exclusion Criteria:
Randomized Study In Severe Aplastic Anemia Patients Receiving Atg, Cyclosporin A, With Or Without G-CSF (SAA-G-CSF)

The purpose of this study is to examine the effect of G-CSF on disease free survival and overall survival in aplastic anaemia patients who also receive ATG and Cyclosporin A.

Open label, randomized, controlled study of G-CSF, ATG and Cyclosporin A versus ATG and Cyclosporin A. Subjects will be evaluated for hematologic response through day 240. Subjects who do not demonstrate a partial or complete remission by day 120 will be randomized to receive either a second course of ATG or continue their current regimen. Subjects who do demonstrate a partial or complete remission will continue their current regimen through day 240 or maintenance of a complete remission for 30 days. The last day of study treatment will be day 240.

Eligibility Criteria:
Inclusion Criteria:

* Severe or very severe aplastic anemia
* Less than 6 months from diagnosis of severe aplastic anemia by bone marrow biopsy
* Ethical - Before randomization is done the subject or legally acceptable representative must give written informed consent for participation in the study

Exclusion Criteria:

* Eligibility for an HLA-matched sibling donor transplant
* Prior therapy with ATG
* Cyclosporin A \<4 weeks before enrollment
* Treatment with G-CSF \<2 weeks before enrollment
* Other growth factors \<4 weeks before enrollment
* Diagnosis of Fanconi anemia, dyskeratosis congenita or congenital bone marrow failure syndrome
* Evidence of myelodysplastic disease
* Diagnosis or previous history of carcinoma (except local cervical, basal cell, squamous cells, or melanoma)
* Subjects who have infection, hepatic, renal cardiac, metabolic or other concurrent diseases of such severity that death is imminent
* Subject is pregnant (e.g. positive HCG test) or is breast feeding
Brivaracetam to Reduce Neuropathic Pain in Chronic Spinal Cord Injury

Spinal cord injury (SCI) is associated with severe neuropathic pain that is often refractory to all pharmacological intervention. Preliminary data suggest brivarecetum is a mechanism-based pharmacological intervention for neuropathic pain in SCI. This randomized, placebo-controlled pilot clinical trial will assess feasibility of a 3-month treatment course with brivarecetum.

The investigations will assess changes in pain intensity and periaqueductal gray hyperactivity. Baseline periaqueductal gray hyperactivity and microRNA levels will be measured as potential biomarkers of response to treatment. These preliminary findings will be used to design larger clinical trials to establish efficacy of brivarecetum to treat neuropathic pain in SCI.

Eligibility Criteria:
Inclusion Criteria:

* Spinal cord injury (SCI)
* Participants must have completed inpatient rehabilitation and are living in the community
* Participant who have severe below-level neuropathic pain (daily average 9/10 or 10/10)
* Participants must have tried and failed to achieve adequate pain relief with the use of other drugs (i.e treatment failed to decrease their pain below a level of 9) and can continue to take spasmolytics, pregabalin, gabapentin, and opioids in unchanged dosing throughout the trial

Exclusion Criteria:

* Pprogressive myelopathy secondary to posttraumatic cord tethering
* Syringomyelia
* Brain injury limiting the ability to follow directions
* Pregnancy or lactation
* Epilepsy
* Impaired liver or renal function
* Contraindications to brivaracetam or pyrrolidine derivatives including allergy, or contraindications to MRI including retained bullet fragments, noncompatible metal implants, and implanted devices such as baclofen pumps
Study to Confirm of the Safety and Tolerability of Brincidofovir in Subjects With BK Virus Infection (Viremia) After Kidney Transplantation

This is a Phase II, multicenter, open-label, randomized, standard of care (SOC) controlled, multiple ascending dose study to assess the safety and tolerability of IV Brincidofovir (BCV) in subjects with BKV infection after kidney transplantation. The study will be conducted at multiple study sites in several countries including Australia and Japan. Subjects who meet eligibility criteria will be enrolled in the study and will be randomized and assigned to BCV or SOC (defined as use of the same immunosuppressant administered during prescreening) before receipt of the first dose of study drug in both the Dose Escalation Phase and the Expansion Phase.


Eligibility Criteria:
Inclusion Criteria:

* Male or female, at least 18 years of age at the time of signing the informed consent at screening.
* Kidney transplant recipient. "BK viral load increase and ≥ 3.6 log IU/mL" at 2 weeks post immunosuppression reduction or "BK viral load does not decrease by ≥ 0.3 log IU/mL" at 4 weeks post immunosuppression reduction during prescreening.

(Note: Immunosuppressant reduction needs to be continued during the screening period).

* eGFR ≥ 30 mL/min.
* Subjects under immunosuppression with tacrolimus, MMF/Myfortic, and/or corticosteroid.

Exclusion Criteria:

* Subjects who weigh ≥ 120 kg.
* National Institutes of Health/NCI CTCAE Grade 2 or higher diarrhea (ie, increase of ≥ 4 stools per day over usual pretransplant stool output) within 7 days before Day 1.
* Poor clinical prognosis, including active malignancy or use of vasopressors other than low dose (eg, ≤ 5 μg/kg/min) dopamine for renal perfusion within 7 days before Day 1.
* Use of renal replacement therapy within 7 days before Day 1.
* History of intolerance to cidofovir or related compounds (ie, other nucleotide derivatives \[adefovir or tenofovir\])
Study of TAP and Laparoscopic and Robotic Gynecologic Procedures and Obese Women

Study the effect of the Transversis Abdominis Plane (TAP) block on pain after surgery for obese women undergoing laparoscopic or robotic gynecologic procedures.


Eligibility Criteria:
Inclusion Criteria:

* BMI greater than or equal to 30, women undergoing laparoscopic or robotic in-patient procedures

Exclusion Criteria:

* Conversions, non-obese women