cyrilzakka/clinical-trials huggingface dataset:
Bilateral Versus Monolateral Repetitive Transcranial Stimulation in Depression

Repetitive transcranial magnetic stimulation (rTMS) has been recently FDA approved for the treatment of resistant depression. No accordance exists on which are the involved mechanisms of action and on which stimulation parameters, frequency and side are optimal.

To compare these different procedures we study patients with unipolar recurrent resistant major depressive disorder in a double-blind, controlled trial randomized to either sequential bilaterally on the right and left dorsolateral prefrontal cortex (DLPFC) or monolaterally on the right DLPFC. Patients will be randomized to receive sequentially low-frequency rTMS at 1 Hz to the right DLPFC and high-frequency rTMS at 10 Hz rTMS to the left DLPFC, or to receive low-frequency rTMS at 1 Hz to the right DLPFC. Significant antidepressant effect as expressed by a reduction of Hamilton Depression Scale score will be recorded in both the groups of patients.

Eligibility Criteria:
Inclusion Criteria:

* Diagnostic and Statistical Manual-IV criteria for Depressive Major Episode Hamilton Rating Scale for Depression -28 (Ham-D)score ≥ 18
* Failure to respond to a minimum of two courses of antidepressant medications for at least 6 weeks

Exclusion Criteria:

* Any comorbid axis I disorder (except simple and social phobia)
* Any other significant medical, particularly neurologic, illnesses (seizures, head trauma and brain lesions)
D20054;LITT for Spine Tumors

The objective of this clinical study is to evaluate the efficacy and safety of spinal laser interstitial therapy in the treatment of metastatic spinal tumors. The investigators hypothesize that rates of local tumor control are comparable between conventional open surgical techniques and spinal laser interstitial therapy.


Eligibility Criteria:
Inclusion Criteria:

1. Histology confirmed spinal tumor involving the T2-T12 spine segments.
2. Indication for spine stereotactic radiosurgery or palliative intervention.
3. Normal neurologic exam at the time of presentation (Frankel grade E).

Exclusion Criteria:

1. Contraindication to MRI
2. ANY neurologic deficit
3. Tumor spanning more than 3 consecutive vertebral segments
4. Contraindication to general anesthesia
5. Pregnancy
Tramadol in Penial Block Does it Improve Efficiency of Postoperative Analgesia in Circumcision

After the consent of the local ethics committee and informed consent of the parents, we conducted a prospective randomized, double-blind study, from 30 June 2014 to 31 December 2014, including one to eight year olds, ASA I or II and Programmed for circumcision.We collected 53 children in each group.

After the consent of the local ethics committee and informed consent of the parents, we conducted a prospective randomized, double-blind study, from 30 June 2014 to 31 December 2014, including one to eight year olds, ASA I or II and Programmed for circumcision. Anesthesia was induced with sevoflurane at 8% and maintained by the same agent at 2%. The children were randomized to 2 groups (n = 53 in each group) to receive 0.1% BPV non-adrenalinated 0.5% / kg on each side with either tramadol 2mg / Kg (G1: GroupBT ) Or saline serum at the same volume (G2: Group B or control). Postoperative analgesia was assessed by: the modified OPS scale at waking (H0), 1st (H1), 2nd (H2), and 24th (H24) PO hour at home, by the number of analgesic inThe hospital and at home, and by the time of the first demand analgesic.

Eligibility Criteria:
Inclusion Criteria:

* ASA physical status I or II
* Were scheudled to circumcision surgery
* Performed by experenced surgeon under general anesthesia

Exclusion Criteria:

* children with full stomach
* A history of gastric reflux
* A history of cardiovascular or neuromuscular disease
* Allergies to the study drugs
A Clinical Trial to Examine the Efficacy of a Dietary Supplement to Improve the Health and Appearance of Hair.

This study evaluates the efficacy of Scale Media's HLV Clinical Formula Hair Vitamins on the health and appearance of hair, focusing on growth, volume, dullness, overall health, hair shedding, fullness, and strength. It is a randomized controlled trial with 50 female-at-birth participants experiencing self-perceived hair thinning.


Eligibility Criteria:
Inclusion Criteria:

* Female at birth, aged 35+.
* Self-perceived hair thinning and increased hair shedding for at least three months.
* Consistent hair care routine for at least one month prior.
* Willing to maintain hair care routine, diet, and refrain from new vitamins or supplements targeting hair growth during the study.
* Generally healthy without uncontrolled chronic diseases.

Exclusion Criteria:

* Hair loss conditions other than female pattern baldness.
* Pregnant, breastfeeding, or trying to conceive.
* Currently taking iron supplements or other hair growth treatments.
* Significant chronic conditions or planned medical procedures that interfere with protocol adherence.
* Recent chemical hair treatments or plans for such treatments during the study.
* Severe allergic reactions to the product's ingredients.
* Recent surgeries, major illnesses, or undergoing chemotherapy/radiotherapy.
Database for Clinical and Anamnestic Data in Pulmonary Hypertension

Pulmonary hypertension (PH) is defined as a pulmonary arterial mean pressure (meanPAP) ≥ 25 mmHg measured in the right heart catheterization.

There are different forms of PH defined in the classification of Dana Point 2008.

PH is diagnosed with right heart catheterization but there are other non invasive methods which can be used for screening like the echocardiography, stress echocardiography and cardio pulmonary exercise testing. In the diagnosis process and in the follow up of PH patients biomarkers like NTproBNP are helpful. There are no specific biomarkers for the disease which can make the diagnosis process easier and predict prognosis.

The systematic data collection in a data base provides better information about patients in daily routine and clinical studies as well as in the design of new studies.

In this study the investigators want to collect clinical data of PH patients and controls in a database as well as blood samples in a biobank. The combination of anamnestic and clinical data and biomarkers should provide a better characterization of our patients and should improve the analysis of the disease development of different PH forms and therapeutic aspects.

After given informed consent patients' data are entered in a database at different time points. The database includes parameter of several invasive and non-invasive investigations like right heart catheterization (RHC), echocardiography, ECG, pulmonary function tests, cardiorespiratory exercise testing, 6-minute walk test, computed tomography, MRI, polysomnography, blood gas analysis and laboratory data as well as demographic data of the patients.

The blood samples are taken during routine punctuation and are stored in our biobank.

Eligibility Criteria:
Inclusion Criteria:

* patients with pulmonary hypertension
* patients at risk for getting pulmonary hypertension
* patients who have symptoms which my be due to pulmonary hypertension when we have their written informed consent.

Exclusion Criteria:

* patients without written informed consent
Insulin, Neurogenetics and Memory in Alzheimer's Disease

This study examines the use of insulin-sensitizing compounds, as therapeutic agents for cognitive impairment in Alzheimer's disease.


Eligibility Criteria:
Men and women with mild Alzheimer's Disease without serious medical or psychiatric comorbid conditions.
COVID-19 Mortality Prediction Model

The objective of this study is to develop and evaluate an algorithm which accurately predicts mortality in COVID-19, pneumonia and mechanically ventilated ICU patients.

Retrospective study of 53,001 total ICU patients, including 9,166 patients with pneumonia and 25,895 mechanically ventilated patients, performed on the MIMIC dataset. The NPH patient dataset includes 114 patients positive for SARS-COV-2 by PCR test.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged 18 years or older
* Record of ICU stay

Exclusion Criteria:

* Patients aged less than 18 years
* Patients for which there were no records of raw data or no discharge or death dates.
Study of Modafinil to Treat Fatigue in Persons With Traumatic Brain Injury

The purpose of this study is to determine whether Modafinil is effective in: (1) reducing fatigue and excessive daytime sleepiness (EDS) in individuals with Traumatic Brain Injury (TBI); and (2) improving cognitive function and quality of life in individuals with TBI.

Background: An estimated 5.3 million Americans are living with a TBI-related disability today. These persons may face many issues, however, two chronic problems seem common to a strikingly large number of those who survive TBI: fatigue and EDS.

Need for Research: Modafinil has been shown to be useful for fatigue and sleepiness in patients with depression, multiple sclerosis, Parkinson's disease and individuals with EDS secondary to a variety of sleep disturbances. However, there has not been any controlled evaluation of Modafinil use for the treatment of individuals with TBI to date.

Current and Future Research Activity: Approximately 60 participants with post-TBI fatigue will be randomly assigned to two 10-week periods of taking either Modafinil or placebo. Participants taking Modafinil during the first 10 weeks will be switched to placebo for the second 10 weeks. Similarly, participants taking placebo during the first 10 weeks will be switched to Modafinil for the second 10 weeks. Outcomes relating to fatigue and EDS will be collected weekly throughout the study. Other outcomes (including general health, depression, and cognitive function) will be collected at the start of each period, 4 weeks into each period, and again at the end of each period. It is hypothesized that participants taking Modafinil will report significantly less fatigue and EDS, report significantly better general health and depression scores, and perform significantly better on tests of cognitive performance in comparison to participants taking placebo.

Eligibility Criteria:
Inclusion Criteria:

* Individuals who sustained a TBI
* were discharged from Craig Hospital following initial rehabilitation
* are at least one year post-injury
* have disabling symptoms of fatigue and/or EDS which compromise their ability to function optimally
* (if female) are surgically sterile, two years post-menopausal, or if of childbearing potential, are using a medially acceptable method of birth control and agree to continue use of this method for the duration of the study

Exclusion Criteria:

* Individuals who have Neurologic and/or neuropsychiatric difficulties and/or deficits which will obscure the evaluation of this medication's effectiveness -
* have a diagnosis of other likely causes of EDS
* have concurrent medication use and/or clinically significant systemic disease that may cause fatigue and/or diminished arousal
* have epilepsy
* currently use of any anti-epileptic medications or Warfarin
* have cardiovascular disease or risks
* have severe renal or hepatic impairment
* have significant psychiatric or behavioral disturbance which would obscure the evaluation of medication effectiveness
* are a pregnant or lactating female
Study of Durvalumab Alone or Chemotherapy for Patients With Advanced Non Small-Cell Lung Cancer (PEARL)

This is a randomized, open-label, multi-center Phase III study to determine the efficacy and safety of durvalumab versus platinum-based SoC chemotherapy in the first-line treatment of advanced NSCLC in patients who are epidermal growth factor receptor (EGFR) and anaplastic lymphoma kinase (ALK) wild-type and with PD-L1 high expression (PEARL)

Patients with stage IV NSCLC will be randomized in a 1:1 ratio to 2 treatment arms (durvalumab or SOC therapy). The dual primary objectives of this study are to assess the efficacy of durvalumab versus SoC in terms of OS (Overall Survival) in all randomized patients and in patients who are at low risk of EM (early mortality)

Eligibility Criteria:
Inclusion Criteria

* Aged at least 18 years
* Documented evidence of Stage IV NSCLC
* No sensitizing EGFR mutation and ALK rearrangement
* PD-L1 high expression
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

Exclusion Criteria:

* Prior chemotherapy or any other systemic therapy for advanced NSCLC
* Prior exposure to immune-mediated therapy, including, but not limited to, other anti-cytotoxic T-lymphocyte-associated antigen 4 (CTLA-4), anti-programmed cell death1 (PD-1), anti-programmed cell death ligand 1 (PD-L1), or anti PD-L2 antibodies, excluding therapeutic anticancer vaccines
* Brain metastases or spinal cord compression unless the patient is stable and off steroids for at least 14 days prior to start of study treatment
* Mixed small-cell lung cancer and NSCLC histology, sarcomatoid variant
* Active or prior documented autoimmune or inflammatory disorders (e.g., colitis or Crohn's disease\]
Optical Coherence Tomography and Optic Neuritis (OCTON)

Optic neuritis (ON) can remain isolated or reveal a widespread and chronic disease of the central nervous system (CNS), a multiple sclerosis (MS) or, more rarely, a Devic's neuromyelitis optica (NMO) or a systemic disease.

The optical coherence tomography (OCT) is a retinal imaging technique to measure the thickness of the retina and its different layers with an accuracy of 4-6 µM.

Costello et al have shown that approximately 75% of 54 MS patients have developed within 3 to 6 months after a ON a loss of 10 to 40 µM in the thickness of the peripapillary retinal nerve fiber layer (RNFL).

The etiologic diagnosis of ON has been transformed in recent years. MS can now be diagnosed by McDonald's MRI criteria and NMO by the AQP4 antibodies (anti-aquaporin- 4) antibodies and the anti-MOG (myelin-oligodendrocyte glycoprotein) antibodies.

The diagnosis and prognosis value of the OCT in patients with ON is not well known


Eligibility Criteria:
Inclusion Criteria:

* first onset of an optical neuritis lasting for less than 3 months

Exclusion Criteria:

* Contra-indication to MRI
* Patient opposed to participation in the study
* Pregnant or lactating woman
* Patient under a measure of legal protection
* Absence of affiliation to social security or universal health coverage (CMU)
Pacing Activity Self-management for Patients With Multiple Sclerosis

Given the lack of evidence in support of pacing self-management for patients with musltiple sclerosis (MS), it is examined whether physical behavior and health status of patients with MS improve in response to a pacing self-management program. The effects of pacing will be compared with those observed when applying relaxation therapy to patients with MS.

Up to 50 patients fulfilling the criteria for the diagnosis of multiple sclerosis (MS) will be randomized to either 3 weeks of pacing activity self-management or relaxation therapy. Both treatment groups will receive 3 weekly sessions spread over 3 consecutive weeks. All treatments will be delivered by occupational therapists or physiotherapists. One treatment session lasts for about 45 minutes each.

Eligibility Criteria:
Inclusion Criteria:

* adult
* age range between 18 and 65 years of age
* willing to sign informed consent form
* fulfilling the criteria for the diagnosis of multiple sclerosis

Exclusion Criteria:

- Not fulfilling each of the inclusion criteria listed above.
Prediction of Transfusion-Associated Complications

Currently, about 350000 red blood cell concentrates are produced from blood donations in Austria every year.

In addition to the main effect of replacing lost blood, red blood cell concentrates also have many undesirable effects - from blood group compatibilities, which are easily avoidable due to care, to storage-related side effects, to mostly intensive care problems as a result of massive transfusions, to system-wide effects such as TRALI, TACO and TRIM.

Before being administered to patients, red blood cell concentrates undergo an extensive quality assurance process in which a large number of parameters are collected. Prior to use on patients, for example, bedside tests and tests for further incompatibilities with a blood sample from the intended patient are performed. With the implementation of Patient Blood Management (PBM) in recent years, the use of red cell concentrates has become more targeted - the number of transfusions is decreasing in most developed countries. However, it is still possible to suffer transfusion-related adverse events (TRAE). Thus, active research activity to reduce these TRAEs continues to be called for.

To date, however, it is not known which patients experience transfusion-related adverse events. Despite the broad measures of hemovigilance and pre-transfusion testing, it is still not possible to predict which individual patient will respond to a transfusion with a typical adverse event such as hypotension, hemolysis, renal failure, or TRALI. It seems understandable that characteristics of the patient as well as characteristics of the administered unit could play a role for this. In particular, it is conceivable that a combination of characteristics of the blood unit and characteristics of the patient could determine a complication in the course of administration. For this reason, it seems attractive to use artificial intelligence and machine learning methods to predict any complications.


Eligibility Criteria:
Inclusion Criteria:

* All adult patients that received at a blood transfusion the Kepler University Hospital in the period between 2016-10-31 to 2020-08-31.

Exclusion Criteria:

None.
Impact of LVAD Implantation on Micro- and Macrovascular Function

End stage heart failure is characterized by a critical inability of the heart to meet the organism's blood demand even under resting conditions. Heart transplantation (HTx) is the established therapeutic approach in the treatment of end stage heart failure and still the gold standard treatment. Left ventricular assist devices (LVADs) are considered as a vital therapeutic option to temporarily or permanently assist the failing circulation. The hemodynamic vascular consequences of implanting LVADs have not been studied in detail. The aim of the study is to investigate the effect of LVAD implantation compared to heart transplant (HTx) on micro- and macrovascular function in patients with end stage heart failure.


Eligibility Criteria:
Inclusion Criteria:

* patients after HTX
* patients after LVAD implantation
* patients with stable coronary heart disease and normal systolic left ventricular function
* healthy volunteers
* written informed consent

Exclusion Criteria:

* acute inflammation
* cardiac arrhythmia
* renal failure
* malignant disease
Explored About Temperature Packing Care to Improve the Quality of Life for Chemotherapy Induced Peripheral Neuropathy (CIPN) in Colorectal Cancer and Gastric Cancer Patient

Investigate the effectiveness of cold and hot compress interventions in reducing peripheral neuropathy induced by Oxaliplatin chemotherapy in colorectal cancer and gastric cancer patients. The primary outcome measures include quality of life, and secondary outcome measures encompass the severity of peripheral neuropathy, manual dexterity assessed through finger strength testing, and the effects on microcirculation blood flow in the hands and feet

Chemotherapy-induced peripheral neuropathy (CIPN) is a common side effect in cancer patients undergoing chemotherapy, with an overall incidence rate of approximately 70-100% for Oxaliplatin. The symptomatology typically manifests as a "glove and stocking" neuropathy, leading to sensory abnormalities that significantly impact patients' activities of daily living and reduce their overall quality of life. Furthermore, it may result in dosage reduction, treatment delays, or interruptions. Studies indicate that residual symptoms persist in 68.1% of patients one month after the completion of chemotherapy, emphasizing the long-term effects of CIPN on post-treatment individuals. Consequently, there is a pressing need for evidence-based preventive intervention research.

Eligibility Criteria:
Inclusion Criteria:

* Individuals aged 20 and above, inclusive, can autonomously decide to participate in this study and complete the Participant Consent Form.
* Patients diagnosed with colorectal cancer, receiving chemotherapy for the first time, and being prescribed the standard FOLFOX regimen with Oxaliplatin as the primary agent are eligible. The dosage is 85mg/m2 administered over a 2-hour injection every 14 days, constituting one treatment cycle. A total of 6 treatment cycles will be conducted.

Exclusion Criteria:

* Individuals with an undiagnosed medical condition.
* Individuals with thyroid disorders, diabetes, undergoing dialysis, pregnant, alcohol abusers, and those with immune-related diseases such as lupus erythematosus, scleroderma, dermatomyositis, and rheumatoid arthritis are excluded from the study..
* Individuals with defects in hands, feet, or fingers.
Excimer Light(308) Therapy for Resistant Alopecia Areata

This study aimed to evaluate the efficacy and safety of the 308-nm excimer lamp in resistant AA treated with topical minoxidil .

Alopecia areata (AA) is a chronic, nonscarring, T-cell mediated autoimmune disease, presenting with localized or diffuse hair fall in hair-bearing areas. Approximately 1.7% of the population experience an episode of AA during their lifetime. Both sexes are equally affected, and most new cases are recorded below the age of 30 years . Excimer laser using high-dose monochromatic UV radiation can trigger apoptosis and induce immunological suppression through altering cytokine production such as IL-4, IL-10, prostaglandin E2, platelet-activating factor, and cis-urocanic acid. Benefits have only been seen with localized patches of AA, and regrowth of hair occurs only in treated areas .

Eligibility Criteria:
Inclusion Criteria:

* ● Having multiple patches of AA.

  * Duration of alopecia \>1 year
  * No topical or systemic treatment for the last 4 months
  * Agreement to regular visits for treatment and follow-up.

Exclusion Criteria:

* ● A single form of AA.

  * Alopecia for \<1 year.
  * Being on other modalities of treatment.
  * Treatment within the last 4 months.
  * Photosensitive disorders.
  * Pregnancy or breastfeeding.
Feasibility and Efficacy of a Combination of a SEMS and Vacuum Wound Treatment (VACStent)

Open, prospective, one-arm feasibility and efficacy study of a European conformity (CE) certified Combination product of two CE certified medical devices in the intended indication.

Evaluation of the suitability of the medical device for sealing leaks in the gastrointestinal tract

The investigators analyzed the outcome of using a hybrid medical device (self-expanding metal stents (SEMS) with negative pressure wound therapy) in the treatment of leaks of the upper gastrointestinal tract

Eligibility Criteria:
Inclusion Criteria:

* Patients with spontaneous, iatrogenic or postoperative leakage in the esophagus, evidence of leakage through an endoscopic examination
* Accessibility of the leak with the delivery system of the VAC stent

Exclusion Criteria:

* Simultaneous participation in other interventional exams
* Endoscopic inaccessibility of the affected section
* Full anticoagulation with international normalized ratio (INR) \> 1.5 and / or partial thromboplastin time (PTT) \> 50 sec, or platelets \<20.000 / μl (after therapeutic correction an inclusion is possible)
* Unstable patients with severe septic disease, who have a clinical history
* Assessment an immediate operation for safe focus switch-off requires
* Ileus image with constant vomiting (after nasogastric tube and gastric emptying an inclusion possible)
* Persons who are in a dependency / employment relationship with the sponsor or examiner stand
* Accommodation in an institution for judicial or regulatory purposes arrangement