cyrilzakka/clinical-trials huggingface dataset:
The Efficacy of Plasmapheresis and Double Filtration Plasmapheresis (DFPP) in Kidney Transplant

At present, the number of end-stage kidney disease patients is increasing. Kidney transplant surgery is one of the treatments that give patients a better survival rate than hemodialysis or abdominal dialysis. In Thailand, there were 5,729 kidney transplant patients or 88.9 cases per million population in 2012. Among this number, 465 were new surgical patients or 7.2 cases per million population.

From the year 2007-2012, the survival rate of the kidney donor from living donor kidney transplant (LDKT) was 98.5 percent and 93.3 percent at 1 and 5 years, respectively.

The most common cause of graft loss was chronic rejection by 33% of all graft loss. However, 16.1 percent were unknown reasons for graft loss.

The research question is "In patients with kidney transplantation who suspected graft rejection" Is it true that doing plasmapheresis or DFPP is no different.

The researcher therefore conducted a comparative study. Is plasmapheresis or DFPP effective or different side effects?

Rejection condition can be divided into 2 groups, namely cellular rejection and antibody-mediated rejection (AbMR) by acute AbMR treatment according to the guidelines for care for kidney transplant patients in Thailand, 2014. The introduction of a single filter plasma (plasmapheresis) or 2 filters (DFPP) in combination with IVIG (intravenous immunoglobulin), which may or may not be given methylprednisolone. If the patients did not response to the treatment, Rituximab or Bortezomib was considered.

Only one previous study showed that among 29 graft rejected patients treated with plasmapheresis, 37.9% had subsequently graft loss and the rest of them had significantly decreasing creatinine level at 1 month follow-up. Another group of 10 graft rejected patients treated with DFPP, 40% had subsequently graft loss. Six patients had decreasing creatinine level at 1 month follow-up.

Both groups do not have complications or side effects from plasmapheresis or DFPP.

The researcher therefore conducted a comparative study.

Is plasmapheresis or DFPP effective or different side effects in treating post-kidney transplant patients who suspected of graft rejection?

Eligibility Criteria:
Inclusion Criteria:

* Patients older than 15 years
* Kidney transplant patients who have been diagnosed or suspected of having graft rejection from antibodies

Exclusion Criteria:

* Incomplete data
Clinical Study to Evaluate the Efficacy and the Safety of Eradication Therapy for Helicobacter Pylori in Functional Dyspepsia

The role of Helicobacter pylori infection in functional dyspepsia remains controversial. Several randomized controlled trials in western countries have shown no significant advantage over placebo. But some recent studies in Asian population were different compared to the result of studies in the Western population. At the present time, it seems to be difficult to conclude the efficacy of the H.pylori eradication therapy in patients with H. pylori-infected functional dyspepsia.

The investigators hypothesize that eradication of Helicobacter pylori has a sustained global symptom improvement in patients with H. pylori infected functional dyspepsia.

Functional dyspepsia: diagnosed by Rome III criteria of Functional gastrointestinal disorder Treatment regimen: Combination of proton pump inhibitor, Amoxicillin, Clarithromycin for 7 days Placebo: Same shaped placebo drugs

Eligibility Criteria:
Inclusion Criteria:

* Functional dyspepsia by Rome III criteria
* Normal endoscopic findings
* H. pylori positive by Urea breath test

Exclusion Criteria:

* Patients with severe concomitant systemic disease
* Patients with GI surgery
* Females with pregnancy or breast-feeding
* Irritable bowel syndrome, inflammatory bowel disease
* Duodenal Ulcer, Gastric Ulcer, GI bleeding
* History of eradication therapy of Helicobacter pylori
* Malignancy
* Psychosomatic disease
Life-Long Monitoring of Diabetes Mellitus in Veneto Region

To evaluate whether patients with type 2 diabetes mellitus can be followed by simplified, centralized and large scale tele-monitoring of blood glucose levels, and whether this intervention produces health and economic benefits when introduced without major changes to the existing organization of a large treatment care center.

The study is designed to evaluate the impact of telemonitoring on the management of Diabetes Mellitus compared with outpatient usual care. From a clinical point of view, the measurements of HbA1c will be taken to assess glycaemic control and the trial will allow to investigate how telemonitoring contributes to improve Diabetes mellitus patients health-related quality of life and reduct the access to hospital facilities (re-hospitalizations, bed-days, specialistic and ER visits) and the anxiety about health conditions. A cost-effectiveness and cost-utility analysis will be carried out in order to determine if and how telemonitoring helps to limit the healthcare expenditure. The evaluation will deal also with organizational changes and task shift due to telemonitoring introduction and patients and professionals perception towards the service.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of type 2 Diabetes
* HbA1c \> 53 mmol/mol (7.0 % according to NGSP)
* Capability to use the devices provided
* Being cognitively able to participate
* Capability of filling in questionnaires in german or greek or italian language
* Absence of severe comorbidity prevalent on diabetes with life expectancy \< 12 months

Exclusion Criteria:

* Pregnancy
A Study to See if we Can Predict How Your Liver Tumor or Liver Metastases Will Respond to Trans-Arterial Embolization (TAE)

The purpose of this study is to see if certain genes the tumor can help predict how the tumor will respond to Trans-Arterial Embolization (TAE). A gene is the basic physical and functional unit of heredity. Genes are made up of DNA; DNA (deoxyribonucleic acid) is the hereditary material in humans. Identifying a gene that can predict how liver tumors will respond to TAE will also help to determine if adjuvant therapy will be needed after TAE.


Eligibility Criteria:
Inclusion Criteria:

* Histopathologic evidence of primary liver cancer or liver metastases
* Indication of TAE for the treatment of liver tumor
* Age ≥ 18 years
* Available tissue with adequate tissue for analysis, verified by a pathologist

Exclusion Criteria:

* History of a second active malignancy with evidence of metastatic disease
Cool Pre-operative TAP Blocks

This is a pilot study of approximately 20 pre-operative patients scheduled for a transversus abdominis plane (TAP) block as pain management for a previously scheduled surgery. Subjects will be randomly assigned to receive either cooled ropivacaine (4°C) during a TAP block or room temperature (between 20-25°C) ropivacaine during the block. The effects of a TAP block generally diminish within 24 hours. We believe that cooling ropivacaine before administration may slightly prolong the analgesic effects of the block and delay time before additional analgesic is requested, resulting in less opioid use following surgery.

After consenting, subjects will be randomized to receive either cooled ropivacaine, administered at approximately 4°C) or room temperature ropivacaine, administered at approximately 20-25°C), during an ultrasound-guided TAP block. Time to anesthesia, or loss of sensation, will be recorded for each subject by a single evaluator, employing the pinch technique and thermosensory perception, using a glove, filled with a slurry of ice water placed on both anesthetized and non-anesthetized areas, for approximately 5 seconds. Time to anesthesia will be recorded when there is a definitive difference on a categorical scale (painful/not painful or cold/not cold) as measured by the subject, between the anesthetized and non-anesthetized areas. Safety outcomes and opioid morphine equivalency will be recorded for all subjects, for approximately 48 hours following surgery.

Eligibility Criteria:
Inclusion Criteria:

1. Patients, aged =18 years of age.
2. Patients, scheduled for surgery, with an order for a TAP block.

Exclusion Criteria:

1. Patients with a history of opioid use disorder.
2. Patients, which are scheduled as the first case of the day.
3. Patients with any history of paralysis/palsy.
4. Patients with a history of sensitivity to local anesthetics, including ropivacaine.
5. Patients, whose blocks are scheduled to be administered by a PGY-1 or PGY-2 resident.
Towards a Viral Etiology of Periodontal Disease in Relation to Radiotherapy Treatment of Head and Neck Cancers

The treatment of otolaryngology (OLR) cancer is based on surgery, radiation, sometimes used in combination with chemotherapy. Patients treated with radiotherapy have multiple oral diseases: mucositis, hyposalivation, tissue fibrosis, exacerbation of periodontitis. Over 70% of patients with head and neck cancers treated with radiotherapy have a lower level of dental clinical attachment and 92% have loose teeth or missing. The management of these oral complications is a priority in OLR oncology. The aim is to improve the oral health of patients to achieve a comfortable life acceptable and necessary for healing.

This project proposes to deepen the investigation with two main objectives:

1. To study in vivo the effect of radiation treatment on the evolution of the viral flora of the periodontium in a cohort of patients and matched controls.
2. To study in vitro the effects of irradiation on the replication EBV (herpesvirus) in producing websites lymphoepithelial tonsillar, and atypical dendritic cells associated with EBV that existence were recently discovered.


Eligibility Criteria:
Inclusion Criteria:

* Patients ≥ 18 years
* Patients treated with curative radiotherapy on tumor site or surgery for cancer of the oral cavity and / or oropharynx
* Patients naive treatments for head and neck cancers
* Patients affiliated or beneficiary of a social security scheme
* Patients who gave informed consent in writing

Exclusion Criteria:

* Patients treated with neoadjuvant chemotherapy, adjuvant or concomitant
* Patients taking immunosuppressants after organ transplantation
* Taking anticoagulants incompatible with dental samples (possible bleeding)
* Patients edentulous and / or whose dental condition is incompatible with the dental samples
Biobank Carcinoma: Storing Blood and Protein of Patients With Cancer

The purpose of this study is to determine, by means of DNA and protein analysis, the relationship between DNA and protein profiles and a number of endpoints, which are important for the patient such as overall survival and side effects.

It has already been known for a long time that cancer is a genetic disorder and that the development of the illness is a very complex interaction between genetic and surrounding factors. Also the response on therapy and the development and seriousness of side effects is stipulated by this complicated collaboration of genetic and surrounding factors. Moreover it is not only the DNA that plays an important role but also the systems of control at protein level. At this moment a lot of questions remain to be answered because up till now the studies were of rather restricted statistic strength with frequently inconsistent dates and moreover retrospective. Major retrospective studies are necessary to distinguish the relationship between DNA/protein patterns and clinical relevant endpoints like prognosis and toxicity in which an as broad as possible patient group is being monitored. For this reason we want to take blood samples in MAASTRO clinic of all patients with lung cancer and to store it encrypted so that we can perform DNA and protein analyses in future and to correlate the results with survival and toxicity of the treatment.

Eligibility Criteria:
Inclusion Criteria:

* cancer

Exclusion Criteria:

* not able to comply with follow-up
UCSF PANC Cyst Registry

Pancreatic cysts are found incidentally on 15-50% of CT and MRIs for all indications and their prevalence is increasing. Many of these cysts may be precursors to pancreatic cancer, and thus pose a substantial risk, however, the vast majority are benign. Increased detection of pancreatic cysts provides an opportunity to diagnose pancreatic malignancy at an early, curable stage yet also increases the potential to over-treat clinically insignificant lesions. This presents a clinical challenge to prevent unnecessary resection of indolent disease, with associated risks of infections, bleeding, diabetes, and costly disability. Unfortunately, there is little information on the epidemiology and natural history of pancreatic cysts to help guide management.

This study develops a large, prospectively managed, electronic, patient-directed pancreatic cyst registry based at UCSF. The UCSF Pancreatic Cystic Lesions Registry (PANC Cyst) will facilitate work to improve clinical care and understanding of pancreatic cysts by prospective follow-up of patients with cystic lesions, especially the diagnostically challenging small cysts, to identify factors related to cyst formation and progression to malignancy. Longitudinal data capture that includes clinical outcomes will also enable us to more precisely define anatomic, radiographic and biomarker information that can be used to differentiate populations of patients for whom surgery is indicated, surveillance is warranted, or no further evaluation is necessary.

Eligibility Criteria:
Inclusion Criteria:

* The inclusion criteria for this study are intentionally broad. Eligible patients for prospective enrollment will include
* Adults ≥ 30 years of age
* Have a radiographic or endoscopic diagnosis of at least one pancreatic cysts regardless of treatment status,
* No history of pancreatic cancer,
* Can speak and read English,
* Have access to a computer or mobile device (\~95% of U.S. population); and
* Are able to complete an electronic informed consent.

Exclusion Criteria:

* Patients who don't speak English,
* Don't have access to a computer or mobile device; or
* Patients who have a cancer diagnosis.
Physical Activity Immediately After Acute Cerebral Ischemia

Stroke is the leading cause of adult disability in Europe and United States and the second leading cause of death worldwide and affects more than 10,000 Danes each year.

Studies in a late and stationary phase after stroke have shown that physical rehabilitation is of great importance for survival and physical ability of these patients, however many studies show that patients lie or sit next to their bed under hospitalization for more than 88.5 % of the daily hours. Physical activity in stroke patients has never previously been measured immediately after debut of symptoms; furthermore there is no knowledge about the optimal dose of physical rehabilitation for these patients.

Accelerometers, small measuring devices, are a relatively new way to measure physical activity precisely, and hence it is possible to obtain an objective measure of how active stroke patients are in the first week after admission. The accelerometers measure a variable voltage, depending on the range and intensity of movement. They can measure movement dependent of the placement of the accelerometer, for instance over the hip, arm or leg. Studies confirm their reliability, even in patients with abnormal gait, such as stroke patients.

Another approach of studying the effects of physical activity and rehabilitation is through the examination of biomarkers. Studies have shown that biomarkers released during physical activity can inhibit biomarkers released after tissue injury in the brain, as seen after stroke. These brain biomarkers cause further damage and studies show that the higher the levels, the higher the damage. It is therefore obvious to examine whether physical activity rehabilitation can down regulate this destructive process in patients with stroke.

Clarification of physical activity in stroke patients immediately after debut of symptoms and examination of both the biochemical aspects of physical rehabilitation as well as the optimal dose of physical rehabilitation is of great importance for many patients, their relatives as well as of a great socioeconomic importance.

The purpose of the project is to describe the amount and pattern of physical activity in stroke patients in the first week after admission. The investigators hypothesis is that patients are inactive for most of the time during hospitalization, activity being correlated with severity of stroke, but not with age, BMI and sex.


Eligibility Criteria:
Inclusion Criteria:

* patients admitted with acute ischemic stroke
* age \> 18 years

Exclusion Criteria:

* symptoms attributable to other diseases than ischemic stroke
* debut of symptoms \> 48 h prior to admission
* consent not given \< 24 h of admission
* pregnancy or lactation
* isolation
* bloodsampling generally not possible
* allergy due to accelerometer wear
* ulcers or other skin diseases in the area of accelerometer placement
Comparison of AT & PR Training to Improve Functional Ability After Breast Cancer Surgery

To determine the effect of aerobic training and progressive resistance training to improve upper limb functional ability after breast cancer surgery


Eligibility Criteria:
Inclusion Criteria:

* a) Breast cancer female survivors eligible under 35-65 years complaining of cancer-related fatigue.

  b) Adjunctive radiotherapy or underwent surgery (lumpectomy or mastectomy), willing to participate will be included in the study.

  c) Shoulder pain d) Decreased ROM e) Primary unilateral BC, ALND, no distant metastases, no previous ALND on the contra lateral side f) No previous history of arm lymph edema

Exclusion Criteria:

- a) Survivors with other concurrent metastasis anywhere else in the body, diagnosed case of any cardiac or respiratory condition, contra-indicated for exercise training (severe dyspnea, chest pain, severe nausea, ataxia, dizziness etc.) b) Any other neurological or recent musculoskeletal problems were excluded from the study.

c) Bilateral mastectomy d) Adjunctive chemotherapy
Bryophyllum Pinnatum Treatment of Anxiety Related to Signs of Preterm Birth

The present IIT (Investigator-Initiated Trial) study is a prospective, randomised, placebo-controlled, double blind trial.

Women hospitalised with signs of preterm birth can be recruited for the study. Participants will take study medication for 2 weeks (or until birth) and fill out a questionnaire at 3 time points (at baseline, after 1 week and after 2 weeks) to assess state of anxiety and sleep quality. Furthermore, information regarding adverse events and the further course of the pregnancy are recorded.

Preterm birth is one of the leading causes for mortality and morbidity in newborns and preterm contractions are the cause of a considerable part of preterm deliveries. In the treatment of preterm labour, tocolytic medications are often used that are associated with numerous side effects for the pregnant woman, which limits their use in time. Preparations from Bryophyllum pinnatum, which demonstrated excellent tolerability, constitute a safe alternative for tocolytic treatment. It was introduced as an alternative tocolytic by anthroposophic medicine in Europe and is used as a monotherapy or add-on therapy for preterm labour in many perinatal clinics in Switzerland today. In vitro studies support the use of B. pinnatum as a tocolytic.

In addition, there are also limited options for the treatment of mental disorders and sleep disturbances during pregnancy. Anxiety plays a major role in the development of preterm labour and often leads to administration of tocolytics longer than necessary. Preparations from B. pinnatum have traditionally been in the treatment of anxiety. Improvements of sleep quality in pregnant women during treatment with B. pinnatum preparations were already shown in previous studies.

This exploratory study aims at investigating the effects of B. pinnatum for the treatment of anxiety in patients with signs of preterm birth.

Eligibility Criteria:
Inclusion Criteria:

* At least 18 years old
* Hospitalisation with signs of preterm birth
* Gestational age at randomisation \>22 weeks (22+0) and \<35 weeks (34+6)
* Good German or English skills
* Written informed consent

Exclusion Criteria:

* Early premature rupture of the membranes (PPROM)
* Factors that make soon delivery likely (pre-eclampsia, suspect cardiotocography, clinical signs of an amniotic infection)
* Body temperature \>38°C
* Cervical opening or cervical length \< 5 mm
* Contraindication for B. pinnatum, lactose or wheat protein allergy
* Taking Bryophyllum 50% chewable tablets or powder 48 h before study inclusion
* Taking psychotropic drugs (Benzodiazepines, antidepressants, neuroleptics)
* Diagnosed psychiatric disease (depression, anxiety disorder, adaptation disorder, post- traumatic stress disorder, bipolar disorder)
* Active participation in another interventional study during the last 4 weeks
* Known or suspected non-compliance with study protocol
* Drug or alcohol abuse
A Long-Term Extension Trial From of SPM 962 in Advanced Parkinson's Disease Patients

* To investigate the safety of once-daily repeated transdermal administration of SPM 962 within a dose range of 4.5 to 36.0 mg/day (54-week treatment period) in Parkinson's disease (PD) patients treated concomitantly with L-dopa in a multi-center, open-label uncontrolled study.
* To investigate efficacy of SPM 962 in an exploratory manner.


Eligibility Criteria:
Inclusion Criteria:

* Subject completed the preceding trial 243-08-001.

Exclusion Criteria:

* Subject discontinued from the preceding trial 243-08-001.
* Subject had a serious adverse event which association with the investigational drug was not ruled out during trial 243-08-001.
* Subject has a persistent serious adverse event at the baseline, which was observed and association with the investigational drug was ruled out during trial 243-08-001.
* Subject had persistent confusion, hallucination, delusion or excitation during trial 243-08-001.
* Subject has abnormal behavior such as obsessive-compulsive disorder and delusion in 243-08-001 study.
* Subject showed serious or extensive application site reactions beyond the application site in the 243-08-001 study.
* Subject has orthostatic hypotension or a systolic blood pressure (SBP) \<= 100 mmHg and has a decrease of SBP from spine to standing position \>= 30 mmHg at baseline.
* Subject has a history of epilepsy, convulsion etc. during trial 243-08-001.
* Subject develops serious ECG abnormality at the baseline.
* Subject has QTc-interval \>= 500 msec at the baseline or subject has an increase of QTc-interval \>= 60 msec from the baseline in the trial 243-08-001 and has a QTc-interval \> 470 msec in female or \> 450 msec in male at the baseline.
* Subject had a serum potassium level \< 3.5 mEq/L at the end of the taper period in trial 243-08-001.
* Subject has a total bilirubin \>= 3.0 mg/dL or AST(GOT) or ALT(GPT) greater than 2.5 times of the upper limit of the reference range (or ? 100 IU/L) at the end of the period in trial 243-08-001.
* Subject had BUN \>= 30 mg/dL or serum creatinine \>= 2.0 mg/dl at the end of the taper period in trial 243-08-001.
* Subject who plans pregnancy during the trial.
* Subject is unable to give consent.
* Subject is judged to be inappropriate for this trial by the investigator for the reasons other than above.