cyrilzakka/clinical-trials huggingface dataset:
The Effect of Renal Denervation on Renal Flow in Humans

Many studies have studied the effect and safety of renal denervation. However, it remains unknown what the exact mechanism behind renal denervation is. It can be hypothesized that a difference in renal blood flow occurs after treatment. In the light of this ignorance, current study will investigate whether renal denervation leads to a difference in renal blood flow after treatment with renal denervation.


Eligibility Criteria:
Inclusion Criteria:

* Individual is scheduled to undergo renal denervation as standard patient care for resistant hypertension.
* Individual is diagnosed with resistant hypertension. Secondary causes and a white coat hypertension are actively excluded.
* Individual is ≥18 years of age.
* Individual agrees to have all study procedures performed, and is competent and willing to provide written informed consent to participate in this clinical study.

Exclusion Criteria:

* Individual is excluded from treatment with pRDN .
* Individual has an estimated glomerular filtration rate (eGFR) of \<30mL/min/1.73m2, using the MDRD calculation.
* Individual has experienced a myocardial infarction, unstable angina pectoris, or a cerebrovascular accident within 6 months of the screening visit, or has widespread atherosclerosis, with documented intravascular thrombosis or unstable plaques.
* Individual has any serious medical condition, which in the opinion of the investigator, may adversely affect the safety and/or effectiveness of the participant or the study (i.e., patients with clinically significant peripheral vascular disease, abdominal aortic aneurysm, bleeding disorders such as thrombocytopenia, haemophilia or significant anaemia).
* Individual is pregnant, nursing or planning to be pregnant.
* Individual has a known, unresolved history of drug use or alcohol dependency, lacks the ability to comprehend or follow instructions, or would be unlikely or unable to comply with study follow-up requirements.
In Vivo Clinical Trial of Porous Starch - Hydroxyapatite Composite Biomaterials for Bone Regeneration

Biodegradable scaffold is an accepted and commercialized medical alternative choice for bone regeneration. In this project we will used our new invention, porous starch- hydroxyapatite composite, for in vivo clinical trial.

The products were prepared from medical grade Thai rice starch mixed with high purity (\>97%) hydroxyapatite powder from fresh cow bone, and already passed in vivo animal biocompatility test, then processed by freeze-drying. There were 44 volunteers from orthopedic and neurosurgical division, 4 and 40 patients, respectively.

Eligibility Criteria:
Inclusion Criteria:

* A patient who requires treatment by surgery and product implant in bone.
* Not indicate sex type
* 18-65 years
* Patients accepted participate in the study.
* Type of surgery will be treat for only bone.

Exclusion Criteria:

* Refused to join the study.
* Patients have an allergic history of carbohydrates and bovine bone.
Evaluating Prenatal Exome Sequencing Study

This study evaluates the impact of the various outcomes of pES (definitive diagnosis, probable diagnosis and IF) on clinical decision making and on parental psychological wellbeing, compared between different analysis strategies to investigate the clinical utility, defined as the balance between potential harms and benefits.

Foetal anomalies as detected on prenatal ultrasound are present in 2-3% of pregnancies. The diagnosis of a genetic syndrome as the underlying cause often has significant consequences for the prognosis and therefore also a significant impact on parental reproductive decision making. In addition to chromosomal testing, prenatal exome sequencing (pES) is increasingly being offered. Although prenatal diagnostic rates are promising, no studies report on the actual implementation of pES in routine care and thus several important knowledge gaps remain regarding clinical utility (the balance between potential harms and benefits) and the preferred analysis strategy (broad versus targeted analysis). A broad analysis has a possible higher diagnostic yield, but it is unknown whether the increased chance of finding an uncertain diagnosis and Incidental Findings outweighs this benefit when it comes to clinical decision making and parental psychological wellbeing. The central aim of this study is to address the knowledge gaps raised above, and increase clinical utility by using the obtained data to improve analysis strategies and to potentially identify new genes.

Eligibility Criteria:
Inclusion Criteria:

* At least one fetal anomaly detected in the current pregnancy, irrespective of gestational age;
* Pregnancy ongoing;
* Mother at least 18 years old and providing consent for pES;
* If father is available: father at least 18 years old and providing consent for pES.

Exclusion Criteria:

There are no exclusion criteria.
Web Based Patient Tutorial on Prolonged Grief

The goal of this clinical trial is to learn about usefulness of the online patient grief tutorial in bereaved adults with Prolonged Grief Disorder who are receiving psychotherapy treatment for it. The main question it aims to answer is how helpful the tutorial was and how much therapists and clients liked it.

Participants will be given access to the online tutorial for use during their talk therapy treatment. Participants will be asked to complete surveys before starting the treatment and after its completion to provide information about their symptoms and feedback about the tutorial.

The Center for Prolonged Grief at Columbia University will send announcements to therapists who have done training in Prolonged Grief Disorder Treatment (PGDT) inviting them to participate in the study and directing them to a study information page in Qualtrics. After reviewing the information sheet, therapists will give their consent for participation and then complete a demographics and professional experience questionnaire. The study coordinator will monitor Qualtrics for new responses and email eligible therapist-participants instructions for accessing the tutorial in Moodle.

Participating therapists will then recruit their patients to take part in the study and direct them to the study information page in Qualtrics to provide consent. Therapists will conduct a clinical assessment to determine that the client is an appropriate candidate for the study. Then therapists will provide the clients with a brief introduction to the patient tutorial and log-in credentials, before starting Prolonged Grief Disorder Treatment. Client-participants will have access to the tutorial for 6 months.

The patient tutorial will supplement a course of Prolonged Grief Disorder Treatment (aka Complicated Grief Treatment or CGT) provided by participating therapists in their practices. Typical course of PGDT takes about 4 months of weekly meetings. Therapists are licensed professionals who will monitor their patients, as usual in practice, and can recommend to stop the study treatment at any point or switch to alternative treatment, as indicated. Frequency, duration and pattern of use of the patient online tutorial will be monitored. Patients will also complete online questionnaires about their grief symptoms before and after treatment and overall experience with the tutorial.

Eligibility Criteria:
Licensed mental health professionals trained in prolonged grief disorder treatment and their clients in treatment for prolonged grief.

Inclusion criteria to participate in step 2 of the study are:

1. a clinical diagnosis of prolonged grief disorder according to DSM-5 criteria,
2. a judgment that grief is the primary problem,
3. a score of at least 30 on the Inventory for Complicated Grief (ICG), and
4. at least 1 year has passed after the death of their loved one (part of DSM-5 criteria).

Exclusion criteria:

1) active suicidal ideation or suicidal intent, current or past psychotic disorder, or active substance use disorder.
MT2018-18: Sleeping Beauty Transposon-Engineered Plasmablasts for Hurler Syndrome Post Allo HSCT

This is a single center, Phase 1/2 study in which patients with Hurler syndrome who have previously undergone allogeneic hematopoietic stem cell transplantation are treated with autologous plasmablasts engineered to express α-L-iduronidase (IDUA) using the Sleeping Beauty transposon system.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Mucopolysaccharidosis type IH (MPS IH, Hurler syndrome)
* Underwent a previous hematopoietic stem cell transplant \>1 year prior to study enrollment
* Age ≥3 years and ≤8 years at time of study registration
* ≥ 10 kilograms body weight
* Creatinine \<1.5 normal for gender and age.
* Ejection fraction ≥ 40% by echocardiogram
* Must commit to traveling to the University of Minnesota for the necessary followup evaluations
* Must agree to stay in the Twin Cities area (\<45-minute drive from the Masonic Children's Hospital) for a minimum of 5 days after each cell infusion
* Voluntary written parental consent prior to the performance of any study related procedures

Exclusion Criteria:

* Prior enzyme replacement therapy within 4 months prior to enrolling on study
* History of B cell related cancer, EBV lymphoproliferative disease or autoimmune disorders
* Evidence of active graft vs. host disease
* Requirement for systemic immune suppression
* Requirement for continuous supplemental oxygen
* Any medical condition likely to interfere with assessment of safety or efficacy of the study treatment.
* In the investigator's judgement, the subject is unlikely to complete all protocol required study visits or procedures, including follow up visits, or comply with the study requirements for participation.
Aortic Valve Reconstruction Using Autologous Pericardium: Single Center Experience With the Ozaki Technique

The aim of this study is to analyse the short-term results of the first patients undergoing the OZAKI procedure (Aortic valve reconstruction using autologous pericardial tissue) at the department of cardiac surgery/ University Hospital Basel/ Switzerland.

The reconstruction of the aortic valve using autologous pericardium, applying the technique Ozaki et al., published first in 2011 provides potential benefits due to the missing necessity of oral anticoagulation and its use in patients with small aortic annuli, because of the huge orifice area. There is a need of more data to evaluate the significance of this technique in the treatment of aortic valve stenosis and regurgitation. The department of cardiac surgery/ University Hospital Basel/ Switzerland started to use this technique in September 2015. The aim of this study is to analyse the short-term results of the first patients undergoing the OZAKI procedure.

Eligibility Criteria:
Inclusion Criteria:

* aortic valve reconstruction using autologous Pericardium (OZAKI technique)

Exclusion Criteria:

* missing informed consent
Osteopathic Manipulative Treatment in Oncology Patients' Management

The aim of present study was to study the osteopathic manipulative effects on pain relief and quality of life improvement on hospitalized oncology geriatric patients. A non-randomized comparison trial was performed in Unit of Oncology Rehabilitation, Palazzolo Institute, Don Carlo Gnocchi Foundation ONLUS, Milan, Italy, from September 2015 to March 2016. 23 older oncology patients were unrolled and allocated in two experimental groups: study group (OMT group, N=12) underwent to osteopathic manipulative treatment associated to physiotherapy and control group (PT group, N = 11) underwent only physiotherapy. At enrollment (T0), 23 recruited oncology patients completed the socio-demographic forms and were evaluated, from external examiner, pain intensity and quality of life. All patients were revaluated at the end of treatment (T4) for quality of life and every week (T1, T2, T3 and T4) for pain intensity. Standard level of significance was p\<0.05.


Eligibility Criteria:
Inclusion Criteria:

* oncology patients
* male and female
* age≥65 years
* with a clinical prognosis of 6-24 months
* diagnosis of multifactorial hyperkinetic syndrome (i.e. metastatic surgery)
* pain intensity score higher than 3, measured with Numeric Rating Scale (NRS)

Exclusion Criteria:

* patients were receiving chemotherapy or radiotherapy treatment at the time of the study
* with mental disorders (MMSE\<10)
* the presence of infection
* anticoagulation therapy
* cardiopulmonary disease
* clinical instability post-surgery.
Autologous Bone Marrow Derived Stem Cells for the Treatment of Multiple Sclerosis.

Until now, there is no effective approach to stop the progression of multiple sclerosis and stimulate re-myelination. Autologous stem cell transplantation shows hope and is quickly developing as an alternative therapy. We propose the use of autologous bone marrow-derived specific stem cell populations and mesenchymal stem cell transplantation (BM-MSC) associated with immuno-modulation to treat patients with relapsing-remitting MS (RRMS).

Multiple sclerosis (MS) is an autoimmune de-myelinating disease in which the myelin sheaths of nerve cells in the central nervous system are damaged.This damage disrupts the ability of parts of the nervous system to communicate, resulting in a range of signs and symptoms, including physical, mental, and psychiatric issues. To date, There is no known cure for multiple sclerosis. Treatments attempt to improve function after an attack and prevent new attacks.

Stem cells possess strong immunomodulatory properties that are shown to play a role in the maintenance of peripheral tolerance and in the control of autoimmunity and that may stimulate repair and regeneration of lesion. Clinical studies have shown that stem cells can be safely harvested and do not form tumors. Most of human stem cell trials have focused on clinical applications for haematopoietic stem cells (HSC), mesenchymal stem cells (MSC), or both. When administered intravenously they have an immune inhibitory effect that can ameliorate animal autoimmune diseases. MSC transplantation significantly improves clinical outcome in experimental allergic encephalitis (EAE). When administered intravenously, MSC may migrate to inflammatory brain lesions and promote survival of nervous cells. Hence, MSC have become the focus of studies as a potential cell therapy for stimulating neuro-protection in human neurodegenerative diseases such as MS.

We propose a safety and efficacy trial of a intravenous and intrathecal injections of autologous bone marrow-derived stem cells into patients with MS.

Eligibility Criteria:
Inclusion Criteria:

* Relapsing-remitting MS (RRMS) patients
* Age 18-50 years
* Disease duration \>= 2 and \<= 10 years
* EDSS: 3.0 - 6.5

Exclusion Criteria:

* RRMS not fulfilling inclusion criteria
* SPMS or PPMSTreatment with any immunosuppressive therapy
* Treatment with interferon-beta or glatiramer acetate within the 30 days prior to transplantation
* Treatment with corticosteroids within the 30 days prior to transplantation
* Relapse occurred during the 60 days prior to transplantation
* History of cancer or clinical or laboratory results indicative of severe systemic diseases, including infection for HIV, Hepatitis B or C
* Pregnancy or risk of pregnancy/ lactation
* Current treatment with an investigational therapy
* Inability to give written informed consent in accordance with research ethics board guidelines
Evaluation of Metabolic Profile of OC000459

An open label study in 9 male and 9 female healthy subjects to determine the pharmacokinetics of parent compound and metabolite after eight days of dosing.

The study will include 9 male and 9 female healthy subjects. Following informed consent and satisfactory screening, each will be dosed for seven consecutive days on an outpatient basis with OC000459 50 mg daily taken before breakfast. On the seventh day, subjects will report to the clinical unit. Following an overnight fast, blood samples will be drawn for baseline safety and pharmacokinetic measurements and a urine specimen will be obtained for urinalysis and baseline metabolite measurements and subjects will be dosed with 50 mg OC000459. Blood samples will then be drawn at selected intervals for 120 hours post dosing and will be analysed for OC000459 parent compound and its metabolite. Urine collections will be obtained over the same period to determine the excretion of the metabolite and parent compound in urine.

Eligibility Criteria:
Inclusion Criteria:

1. Healthy male and female subjects, any racial group
2. Aged 18-55 years inclusive
3. Able to comply with the protocol
4. Subjects with a Body Mass Index (BMI) of 21-28 (BMI = Body weight (kg) / (Height (m)2)
5. Subjects with no clinically significant abnormal serum biochemistry, haematology and urine examination values within 21 days of the first dose

Exclusion Criteria:

1. A history of gastrointestinal disorder likely to influence drug absorption
2. Receipt of any medication including over the counter preparations and vitamins within 14 days of the first study day with the exception of paracetamol up to a maximum of 2 g daily
3. Evidence of clinically significant renal, hepatic, cardiovascular or metabolic dysfunction
4. A history of drug or alcohol abuse
5. Inability to communicate well with the investigator (i.e., language problem, poor mental development or impaired cerebral function)
6. Participation in a clinical study within 3 months of the first dose of study drug. Subjects will be checked against The Over Volunteering Prevention System (TOPS)
7. Donation of 450 mL or more blood within 60 days of the first dose of study drug
8. A history of hypersensitivity and/or idiosyncrasy to any of the test compounds or related drugs or excipients employed in this study
9. Pregnancy or lactation
Stress Prevention at Work: Intervention Efficacy and Implementation Process Evaluation

The Stress prevention at work (SPA) project intends to evaluate the method named Productivity Measurement and Enhancement System (ProMES) as a stress preventive approach among health care employees.

Stress-related illnesses are today together with musculoskeletal disorders the predominant cause of production loss and absenteeism. The risks of developing stress-related mental illness is today well established, however, it is less studied how this can be successfully treated or prevented in workplaces through interventions.

The SPA project intends to evaluate the method the Productivity Measurement and Enhancement System (ProMES). The method is mainly evaluated for production improvement, but there are indications that it also has stress-reducing effect on working groups. The method gives employees within health care opportunities to participate actively in productivity-enhancing measures. The employees, along with their immediate supervisors, identify and prioritize responsive and desirable results in all of the activities important dimensions. International studies have shown that participation (participation) has positive effects on employee performance and attitudes.

The aim of this study is to test whether efforts in targeting the organization and work environment can reduce stress and prevent stress-related ill health in the workplace. Primary outcomes of the study are tense work i.e. imbalance between demand and control and other primary indicators of stress, such as sleep and recovery.

The hypothesis in study 1 is that productivity enhancing workplace interventions based on a participative approach also increases employees' sense of control and control over their own work. This in turn means that the method also could be used to reduce the occurrence of tense work and thus affect / reduce the stress-related illness.

Eligibility Criteria:
Inclusion Criteria:

* All employees (18-67 years) employed at the intervention and control primary care units, who were actually working at the time for this study

Exclusion Criteria:

* employees absent due to long-term illness,
* employees absent due to parental leave
* employees absent due to long-term studies
A Study on Predictive Value of ERCC1 in Esophageal Cancer Patients Treated With Paclitaxel and Cisplatin

The purpose of this study is to evaluate the efficacy and safety of first-line chemotherapy with cisplatin and paclitaxel in esophageal cancer

Open label single arm phase II study of cisplatin and paclitaxel in patients with recurrent or metastatic esophageal cancer. 92 Patients will be enrolled in this local trial. The primary objective of this study is to determine the response rate of the treatment.Schedule for this study is as follows: paclitaxel 150 mg/m2 will be administered as an intravenous infusion over 3 hour on Days 1, followed by cisplatin 50 mg/m2 on Days 2. This study will also include the investigation of ERCC1 expression in order to assess determinants of efficacy of the treatment with cisplatin and paclitaxel in the study population.

Eligibility Criteria:
Inclusion Criteria:

* Histologically proven diagnosis of the squamous cell carcinoma or adenocarcinoma of esophagus
* locally advanced, recurrent or metastatic disease
* Performance Status of 0-2 on the Eastern Cooperative Oncology Group (ECOG) performance status Scale
* Previous adjuvant or pre-operative chemotherapy without containing paclitaxel or platinum at least 12 months before enrollment
* Adequate organ function including the following:

Bone marrow: absolute neutrophil count (ANC) \>or equal to 1.5 \* 109/L, platelets \>or equal to 100 \*109/L, hemoglobin \> or equal to 10 g/dL.

Hepatic: bilirubin \< or equal to 1.5 x ULN; alkaline phosphatase, aspartate transaminase (AST) and alanine transaminase (ALT) \< or equal to 3 x ULN (alkaline phosphatase, AST, ALT minor or equal to 5 x ULN is acceptable if liver has tumor involvement), serum albumin \> or equal to3g/dL.

Renal: Calculated creatinine clearance major or equal to 60 ml/min (using the standard Cockcroft-Gault formula).

Exclusion Criteria:

* No Prior palliative chemotherapy for advanced disease
* Previous radiation therapy is allowed but should have been limited and must not have included whole pelvis radiation. Patients must have recovered from the toxic effects of the treatment prior to study enrollment (except for alopecia). Prior radiotherapy must be completed at least 30 days before study enrollment
* Known or suspected brain metastasis
* Second primary malignancy