cyrilzakka/clinical-trials huggingface dataset:
An Evaluation of IV Gamma Globulin As a Method to Improve Kidney Transplant Survival in Patients With End-Stage Renal Disease Who Are Highly Sensitized to Transplant Antigens

This study is designed to test the clinical and laboratory observations that suggest IVIG given before and after kidney transplant to patients who are sensitized (highly sensitive) to certain transplant antigens could result in reduced sensitization and reduced rates of kidney rejection.

Some ESRD patients are highly sensitive to certain transplant antigens (foreign substances that activate the immune system) and must wait for a long time before a well-matched kidney becomes available. Transplant rejection is more likely among highly sensitized patients than in patients who are not highly sensitized. There is no proven method to improve a highly-sensitized patient's chances of receiving and keeping a transplanted kidney.

Kidney transplantation is the treatment of choice for patients with end-stage renal disease (ESRD). However, many patients do not receive this treatment due to immune sensitization to HLA antigens. IVIG has been shown to somewhat reduce anti-HLA antibody activity. By blocking this activity, IVIG may make transplants more feasible and increase graft survival in transplant recipients.

Patients are randomized to receive IV infusion of either 2 g/kg (maximum dose 180 g) IVIG 10% S/D (Gamimune-N, 10%, manufactured by Bayer) or placebo (0.1% human albumin, manufactured by Bayer) at time of dialysis at study entry and monthly for 3 months. If patients have not received a transplant at 1 year, they receive a "booster" dose of IVIG or placebo; patients receive another booster at 24 months if transplant still has not occurred. If transplant occurs, patients receive 2 g/kg (up to 180 g) IVIG or placebo monthly for 4 months, beginning at time of transplant. Before and after initiation of IVIG/albumin placebo treatment, specific immune parameters, including panel reactive antibodies (PRA) levels, MLR, serum inhibition of MLR, and cytokine gene transcription in the MLR, and AECA levels are measured. Outcomes studied include time on dialysis and graft survival rates.

Eligibility Criteria:
Inclusion Criteria

You may be eligible for this study if you:

* Are 12 years of age or older.
* Have end-stage renal disease.
* Currently receive either hemo- or peritoneal dialysis.
* Have an elevated (\> 50%) level of panel reactive antibodies (PRA level) on 3 consecutive monthly tests.
* Agree to practice sexual abstinence or to use effective means of birth control/contraception during the study and for 1 year after.

Exclusion Criteria

You will not be eligible for this study if you:

* Have received IVIG for any reason within 6 months prior to enrollment.
* Are HIV positive.
* Are Hepatitis B e-antigen/hepatitis B viral DNA-positive.
* Have selective IgA deficiency or have known antibodies to IgA.
* Are allergic to human immune globulin.
* Are pregnant or breast-feeding.
Pain and Comfort in Diabetic Foot Ulcer Care

The purpose of this study is to reveal the effect of cold application of 0.9% NaCl solution used during diabetic foot ulcer (DFU) care on the pain and comfort levels of patients. In this direction; - Cold application has no effect on pain and comfort levels in DFU care. - Cold application has an effect on pain and comfort levels in DFU care. Hypotheses were created. In order to reveal the effect of cold application, 0.9% NaCl was compared to the intervention group (+4ͦ C and +8ͦ C); NaCl ( sodium chloride) compared to the control group (+18ͦ C and +24ͦ C).

Diabetic foot ulcer (DFU) prevalence is increasing in parallel with the increasing number of patients with diabetes mellitus (DM). Patients experience pain due to debridement, which is frequently used in DFU care. Therefore, it is seen that nonpharmacological strategies are needed in pain management, unlike pharmacological methods. For this purpose, this single-blind randomized controlled study attempted to provide more information to the literature for supportive care in DFU care. 68 DFU patients were included in the study. After being randomly assigned to the groups, the care solution was applied cold or hot according to the procedure in the DFU care performed in the outpatient clinic. Data were collected before (10 min before), during and after (10 min after) the procedure. Kruskal Wallis, One Way ANOVA, Post Hoc pairwise comparison tests and corrected Bonferroni were used in the analyses.

Eligibility Criteria:
Inclusion Criteria:

* Patients over the age of 18 with a diabetic foot wound diagnosed with diabetes mellitus,
* No cognitive impairment,
* No hearing, understanding or speaking problems,
* VAS\>3 points,
* Patients who consent to participate in the study

Exclusion Criteria:

* Patients who have been decided to have an intervention to reduce pain before the procedure (such as local anesthesia, nerve blockade, opioid analgesics, etc.) -Patients with VAS \<3 points,
* Patients with arterial or venous ulcers other than DFU
Fludarabine and Rituximab for the Treatment of Marginal Zone Non-Hodgkin's Lymphoma

The purpose of this study is to determine the effectiveness of six cycles of concurrent fludarabine and rituximab in patients with mucosa-associated lymphoid tissue (MALT) lymphoma, marginal zone lymphoma (MZL) or CD5-, CD10-, CD20+ low-grade B cell lymphomas.

Objectives:

Primary

- To estimate the objective response rate.

Secondary

* To assess the safety.
* To describe the progression-free survival at one year.
* To examine the association between clonal cytogenetic abnormalities identified by FISH, and the objective response rate as well as the progression-free survival at one year.

Target enrollment was 30 eligible patients. An 80% objective response rate at 1 month restaging after 6 cycles was considered as evidence of activity in this patient population while 60% was not considered activity. If at least 22 patients achieved objective response the treatment would be considered promising. With 30 eligible patients, the probability of observing this was 0.87 assuming a true rate of 80% and 0.09 assuming a true rate of 60%.

Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed, newly diagnosed or relapsed MALT, marginal zone lymphoma, or low-grade B cell lymphoproliferative disorder which is CD5-, CD10- and CD20+
* Pathology must be reviewed at Brigham \& Women's Hospital, Massachusetts General Hospital, or the University of Rochester James P. Wilmot Cancer Center prior to enrollment
* Documentation of CD20+ status
* Must not be a candidate for local radiotherapy with curative intent
* If gastric MALT, not a candidate for antibiotic therapy with curative intent
* Patients with leukemic phase marginal zone lymphoma are eligible if their absolute lymphocyte count is \>10,000 / µl
* Prior treatment with rituximab is permitted, if rituximab induced an objective response which persisted for at least 6 months
* Prior radiotherapy is acceptable
* Measurable disease
* ANC: \> 1000/mm3
* Platelets: \> 100,000/mm3
* Hemoglobin: \> 7 gm/dL
* Adequate renal function as indicated by serum creatinine \<= 2 mg/dL.
* Adequate liver function, as indicated by serum total bilirubin \<= 2 mg/dL.
* AST or ALT \<3x Upper Limit of Normal unless related to primary disease.
* Men and women of reproductive potential must agree to use an acceptable method of birth control during study treatment and for six months after completion of study treatment.
* WHO Performance status \</= 2
* Subject has provided written informed consent.

Exclusion Criteria:

* Patients with Waldenstrom's Macroglobulinemia or lymphoplasmacytic lymphoma are excluded
* History of HIV
* Active infection
* Known CNS disease
* Pregnant (a negative serum pregnancy test should be performed for all women of childbearing potential within 7 days of treatment) or currently lactating women
* Prior treatment within the last three weeks
* Prior fludarabine
* Positive direct antiglobulin test
Insect Protein and Muscle Protein Signaling

Randomized parallel study investing the effect of intake of different protein sources (whey, insect and pea) on the muscle protein synthesis. Activation of the signaling pathway leading to muscle protein synthesis is investigated by western blotting and Real time quantitative polymerase chain reaction (qPCR or PCR). Urine, blood and muscle is moreover investigated by metabolomics analysis.

Background:

Sarcopenia is a syndrome highly prevalent in the older population, characterized by muscle loss and a decrease in muscle strength. This leads to loss of physical function, decreased life quality and well-being and an increased risk of early death. Research has shown that both ingestion of protein and physical activity is able to diminish the loss of muscle mass during aging and thereby reduce the prevalence of sarcopenia and diminish the consequence of the disease. This study will investigate if more sustainable protein sources of good quality can increase the muscle protein synthesis and thereby prevent sarcopenia.

Aim:

The aim of this project is to investigate the effects of insect protein on the stimulation of muscle protein synthesis. The effects of protein will both be studied alone and in combination with exercise in perspective of preventing loss of both muscle mass and muscle strength. The potential of insect protein will be elucidated by comparison with other alternative plant-based protein sources in this case pea protein. In addition, whey protein will be included as a positive control as it may be regarded as the most established dietary protein source combatting muscle loss.

Method:

Young(18-30 years old) healthy men (n=60) are randomized in 3 groups to ingest either insect protein, pea protein or whey protein. Urine are collected 24 hours prior to the experiment while a blood sample and a muscle biopsy is collected at the beginning of the study. The subjects are instructed to perform one-leg exercise (knee extension, 5 sets of 10 repetitions, 10 repetitions-maximum) after which the subjects ingest the assigned protein bolus. Urine and blood samples are collected in the following hours and one muscle biopsy is collected from both the exercised and the non-exercised leg at 3 hours after protein ingestion. The expression of messenger RNA (mRNA) and protein related to the mTORC pathway in the muscle is investigated by qPCR and western blotting. In addition, metabolites in urine, blood plasma and muscle tissue are investigated by metabolomics analysis.

Eligibility Criteria:
Inclusion Criteria:

* male
* 18-30 year
* able to read and understand danish

Exclusion Criteria:

* smoking
* resistance training more than 1 time pr month
* endurance training more than 2 hours pr week
* Allergy toward shellfish, house dust mites or the protein sources.
* knee problems effecting the exercise
* weight change more than 5 kg the last half year
* medicine which can effect the protein turnover
* Disease in joint, or muscle as well as metabolic diseases.
Oral Dexamethasone for the Management of Symptomatic Irreversible Pulpitis Without Performing Pulpotomy

The efficacy of short course orally administered dexamethasone on the reduction of pain before conventional pulpotomy has not yet been demonstrated.

Therefore, the aim of this randomized clinical study is to assess the effect of dexamethasone on the reduction of pain in mandibular molars with irreversible pulpitis, without performing conventional pulpotomy in comparison to pain following pulpotomy.


Eligibility Criteria:
Inclusion Criteria:

Systemically healthy patients (Category: American Society of Anesthesiologists class 1) (ASA House of Delegates 2014) aged between 18 and 40 years with mandibular molars diagnosed with symptomatic irreversible pulpitis and a radiographically normal periapical region were included. Diagnosis was based on clinical and radiographic examination and pulp sensibility testing. Teeth were included if they responded long-term to cold test, the cold test was performed by injecting a syringe filled with cold water at the level of the suspicious tooth and the adjacent teeth. Teeth with deep occlusal decay, old restoration with underlying decay, recent restoration or crown were included. Patients that agreed to be contacted by phone after the emergency visit until pain relief, that were available to come back after the emergency visit for complete endodontic treatment and who had the ability to understand the informed consent form and pain recording scales used within this study were included.

Exclusion Criteria:

Teeth with acute or chronic apical abscess, pulp necrosis, septum syndrome and open apices were excluded. Medically compromised patients, pregnant and lactating women were excluded. Patients having history of allergy to local anesthetic solutions or any of the experimental drugs, on long-term medications that influenced pain threshold, analgesics, steroids and/or antibiotics in the recent past 24 h, were also excluded from the trial. Patients that suffered from a viral disease in evolution (Hepatitis, Herpes Zoster, Ocular Herpes), have or had a history of tuberculosis, hypertension, renal insufficiency, adrenocortical dysfunction, epilepsy, systemic fungal infections, GUILLAIN-BARRE syndrome, peptic ulcers and gastro intestinal disorders were excluded. Patients with Temporomandibular joint disorders were excluded. Patients suffering from mental disabilities were also excluded.
Leukemic Phase of ALCL

Collecting data about the rare leukemic presentation of anaplastic lymphoma to study the characteristics of patients with leukemic phase of ALCL


Eligibility Criteria:
Inclusion Criteria:

* Patients presenting a leukemic phase of anaplastic lymphoma

Exclusion Criteria:

* None
Comparison Between LDCT With DL Recontruction and Standard Dose CT

This prospective study aims to perform intra-individual comparison of the image quality between low dose liver CT with deep learning reconstruction and standard dose liver CT with iterative reconstruction in patients with liver metastasis.


Eligibility Criteria:
Inclusion Criteria:

* patients with underlying malignancy and suspicion of liver metastasis
* patients with known liver metastasis and on follow-up
* AND scheduled for contrast enhanced abdomen CT
* signed informed consent

Exclusion Criteria:

* absolute or relative contra-indication for contrast-enhanced CT
* diffuse infiltrative liver lesion or multiple (\> 10) metastases
Memantine Augmentation in Obsessive-Compulsive Disorder

The purpose of this study is to determine whether memantine is safe and effective when used as an augmentation to standard treatment for Obsessive-Compulsive Disorder (OCD).

The purpose of this study is to determine whether memantine (Namenda), in doses up to 20 mg/day, will be effective in treating the OCD of adult patients who have not responded to their OCD medication. Memantine is not FDA approved for OCD, but is approved for the treatment of Alzheimer's Disease. Memantine appears to work by regulating the activity of glutamate, one of the brain's specialized messenger chemicals, which may play a role in OCD. All patients in the study will receive memantine; no one will receive placebo.

Eligibility Criteria:
Inclusion Criteria:

* at least 18 years of age
* suffering from OCD
* Y-BOCS score of 18 or greater
* taking a therapeutic dose of an anti-OCD medication specified in the protocol

Exclusion Criteria:

* diagnosed with a mental disorder other than OCD
* taking tiagabine or pregabalin
* having had a previous trial of memantine
* receiving therapy for OCD
* substance abuse in the last 6 months
* personality disorders sufficiently severe to interfere with study participation
Can Urinary Partial Oxygen Pressure be an Indicator of Acute Kidney Injury in Patients With Sepsis?

The ability of bladder urinary partial pressure, measured as a reflection of renal medullary oxygen tension, which is an indicator of the development of acute kidney injury (AKI), to predict the development of AKI at an early stage.

Patients hospitalised in the intensive care unit with a diagnosis of sepsis will be followed up for the development of ABH. This follow-up will be performed for 5 days after hospitalisation. During this period, patients will be sampled for NGAL 5 times in total, once every day. PuO2 will be sampled daily to determine PuO2 and to observe the development of AKI, and in cases of hypotension where the mean arterial pressure falls below 65 mmHg or in cases of severe acidosis, extra will be sampled at least 5 times, once every day. PuO2 will be analysed in the blood gas device and PuO2 value will be recorded. For NGAL analysis, patient blood will be collected in ETDA tubes and stored at -80 °C until analysis. NGAL will then be measured by turbidimetric imminoassay method. The comorbidities of the patients will be questioned and recorded, the types and amounts of fluids taken, whether they received blood and blood products, and if so, which product and how much they received will be recorded. APACHI II score and SOFA scores of the patients at hospitalisation will be recorded. GCS, whether mechanical ventilation support is provided or not, if any, ventilation method, mode and ventilation parameters will be recorded. In addition to these, mean arterial pressure, pulse, temperature, SpO2, FiO2 values will be recorded clinically. Haemoglobin, haemotocrit, platelets, bun, creatinine, biluribins, liver function tests and arterial blood gas will be recorded in the laboratory. In addition, whether the patients have ARDS, whether they are receiving renal replacement therapy and if so, the prescription and ultrasonography findings will be recorded.

Eligibility Criteria:
Inclusion Criteria:

* patients admitted to intensive care unit with sepsis

Exclusion Criteria:

* Causing an infection other than sepsis at the time of admission
* Acute renal failure at the time of admission
* Having a creatinine value above 1.5 mg/dL at the time of admission
* Previously known chronic renal failure or being on a routine dialysis programme (receiving renal replacement therapy)
* Having one kidney
* Having another known kidney disease
Evaluation of Fractional CO2 Laser Treatment Efficacy and Comparison to Vaginal Estrogen Therapy in Postmenopausal Women With Vulvovaginal Atrophy

Forty-five women will be included in a double-blind randomized trial in order to compare fractional CO2 laser treatment, local estrogen therapy and the combination of both treatments for Vulvovaginal Atrophy (VVA) and determine the efficacy and possible adverse effects CO2 laser treatment.

Vulvovaginal atrophy (VVA) symptoms are strongly associated with declining ovarian function and estrogen levels in postmenopausal women, having a considerable impact on women's life quality. Topical hormonal therapy and hormonal replacement are widely used to alleviate VVA symptoms. In this context, minimal invasive fractional CO2 laser emerges as an alternative non-hormonal therapy, especially in patients that present contraindications to hormonal therapy. Objective: Compare fractional CO2 laser treatment, local estrogen therapy and the combination of both treatments for VVA and determine the efficacy and possible adverse effects CO2 laser treatment. Materials and Methods: Forty-five postmenopausal women will be randomized in three double-blinded groups of treatment consisting of CO2 laser and placebo of estrogen vaginal cream, placebo of CO2 laser and estrogen vaginal cream and CO2 laser and estrogen vaginal cream. Assessment of baseline characteristics and follow-up will be obtained through self-completion questionnaires (Female Sex Function Index, International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF), Vulvovaginal Symptom Questionnaire and The Menopause-Specific Quality of Life (MENQOL)). Frost Index and Vaginal Health Index (VHI) are part of objective clinical and histologic analyses. Colposcopy, vaginal cytology and middle third lateral vaginal wall biopsy will also be performed at baseline and at week 17.

Eligibility Criteria:
Inclusion Criteria:

* 45-65 women with amenorrhea for over 24 months.
* Clinical vaginal atrophy diagnosis.

Exclusion Criteria:

* BMI \> 35.
* Previous use of oral estrogen therapy in the last 6 months.
* History or current diagnosis of cancer.
* Altered cervical smear in the last 12 months.
* Renal or hepatic insufficiency.
* Drug-induced menopause.
* Previous use of steroids.
* Previous vaginal radiotherapy therapy.
* Vulvovaginitis.
Acute Agitation in Emergency Psychiatry

The purpose of the study is to improve the pharmacological treatment of psychiatric patients with acute agitation.

The initial treatment of acute agitation aims to reduce suffering, abort the immediate risk of harm to self or others, and prevent the use of coercive measures such a physical and mechanical restraint. With this research project, we aim to build the initial structure of a visionary platform design and to examine the efficacy, tolerability, and safety of two hitherto under-investigated compounds versus the current standard of care for acutely agitated patients when de-escalation techniques have failed. After obtaining the results of the initial phase, we plan to apply for future funding to maintain and expand the platform design with the addition of relevant experimental arms. The proposed platform design aims to anwer the question What is the best treatment for acutely agitated patients in inpatient psychiatric settings?

Eligibility Criteria:
Inclusion Criteria:

* 18-64 years
* Agitation with the need for tranquillization in inpatient psychiatric settings including psychiatric emergency rooms
* Total score of ≥14 on the PANSS Excited Component (PEC)
* A score ≥4 on at least 1 of the 5 items of the PEC
* Informed consent obtained prior to the occurrence of the emergency

Exclusion Criteria:

* Involuntary psychiatric admission according to the Danish Mental Health Act
* Female patients who are breastfeeding
* Female patients aged \<50 years and unable to perform a negative urine screen for pregnancy and not using safe contraceptives
* Body weight \<50 kg
* Extreme obesity defined as estimated BMI≥ 40 kg/m2
* Clinical situations where acute administration of an antipsychotic is preferred to treat acute agitation (in the opinion of the investigator)
* The patient deemed unwilling or unable to cooperate with study procedures (in the opinion of the investigator)
* Insufficient language skills that interfere with reading, writing, and providing written informed consent in Danish or other available languages (in the opinion of the investigator)
* Clinical suspicion of contraindications for one of the treatment arms
* Use of benzodiazepines, other sedatives, or antipsychotic drugs in addition to usual treatment (i.e., additional PN sedative prescriptions) in the 4 hours before study treatment
* Known allergy to any of the study medications