cyrilzakka/clinical-trials huggingface dataset:
Treatment with Intensity Modulated Radiotherapy on the Change of Cognitive Function in Nasopharyngeal Carcinoma Patients: a Prospective Cohort Study

This is an observational cohort study aimed at investigating changes in hippocampal function and its impact on cognitive function in newly diagnosed nasopharyngeal carcinoma patients without metastasis, from baseline to a period after radiotherapy.


Eligibility Criteria:
Inclusion Criteria:

* Newly diagnosed nasopharyngeal carcinoma patients confirmed by pathology, who have not received surgical, induction chemotherapy, radiotherapy, or other anti-tumor treatments;
* Clinical stage classified as AJCC 8th edition Stage I-IVa, with no distant metastasis, and who are scheduled to undergo intensity-modulated radiotherapy (IMRT) according to clinical plans;
* Pathologically diagnosed as non-keratinizing nasopharyngeal carcinoma (differentiated or undifferentiated type, i.e., WHO type II or III);
* All participants are Han Chinese and right-handed;
* Age between 18 and 60 years, with an education level of junior high school or above;
* No history of neurological diseases or head trauma;
* No other severe systemic diseases other than nasopharyngeal carcinoma;
* No hippocampal invasion before treatment;
* Routine MRI before treatment shows no abnormal lesions in the hippocampus;
* No family history of mental illness.

Exclusion Criteria:

* Routine MRI before treatment shows abnormal lesions in the hippocampus;
* Contraindications for magnetic resonance examination;
* Concurrent other brain diseases;
* Pathologically diagnosed as keratinizing squamous cell carcinoma (WHO type I);
* Patients with recurrence or distant metastasis;
* Patients who have previously undergone radiotherapy or chemotherapy;
* Abnormal function of vital organs such as heart, brain, or lungs;
* History of head trauma or mental/neuro diseases;
* Age less than 18 years or greater than 60 years;
* Patients whose initial treatment plan is changed during the observation
* period due to disease progression (including residual tumors after
* radiotherapy, tumor recurrence, or newly developed distant metastasis);
* Patients with diabetes or hypertension;
* Those unable to cooperate in completing neurocognitive scale testing;
* Those with other uncontrolled severe diseases.
Laser Assisted Sperm Selection of Viable Immotile Testicular Sperm in Azoospermic Infertile Men

This study aims to investigate the outcome of ICSI after using LAISS for selection of viable immotile testicular sperm in azoospermic infertile men.

Patients will be randomly assigned to 2 groups. In (LAISS) group, viable immotile testicular sperms will be selected before ICSI using laser assisted immotile sperm selection (study group). In (HOST) group, viable immotile testicular sperms will be selected before ICSI using hypo-osmotic swelling test (control group).


Eligibility Criteria:
Inclusion Criteria:

* Eligible couples are those undergoing ICSI due to azoospermia with testicular biopsy positive for sperm (either fresh or cryopreserved) following testicular sperm extraction (TESE) or aspiration (TESA).

Exclusion Criteria:

* Cases with female factor infertility or woman age above 35 years will be excluded.
Validity and Reliability of Outcome Measures in Patients With Cancer of the Head and Neck

The purpose of this study is to establish the Six-Minute Walk Test, 10-Meter Walk Test, 30 Second Chair Stand, Linear Analog Scale of Function, and the Modifed Brief Fatigue Inventory as reliable and valid outcome measurements for patients with head and neck cancer.

This study will be looking at the test-retest reliability and validity of various outcome measures in patients with cancer of the head and neck. Testing will occur in 2 visits within one week.

Eligibility Criteria:
Inclusion Criteria:

* Age 18-85
* Within 3 months of surgery, or are currently undergoing radiation and/or chemotherapy for a diagnosis of head and neck cancer
* Community dwelling
* Able to provide informed consent, answer relevant questionnaires,follow instructions provided during testing

Exclusion Criteria:

* Vulnerable populations (minors, prisoners)
* Medical comorbidities which limit the safe completion of the 6MWT, gait speed, and strength testing
* Inability to return for a second day of testing within one week
Study With Vortioxetine on Emotional Functioning in Patients With Depression

The study will evaluate effectiveness of flexible dose vortioxetine 10-20 mg/day on emotional functioning in patients with MDD with an inadequate response to SSRIs/SNRIs.


Eligibility Criteria:
Inclusion Criteria:

* The patient has a primary diagnosis of single or recurrent MDD according to DSM-5®. The current major depressive episode (MDE) must be confirmed using the Mini International Neuropsychiatric Interview (MINI).
* The patient has had the current MDE for \<12 months.
* The patient has a Montgomery and Åsberg Depression Rating Scale (MADRS) total score ≥ 22 and ≤ 28 at the Baseline Visit.
* The patient has been treated with SSRI/SNRI monotherapy (citalopram, escitalopram, paroxetine, duloxetine or venlafaxine) for at least 6 weeks at adequate dose for the current MDE and with an inadequate response and is a candidate for a switch in the investigator's opinion.
* The patient wants to switch antidepressant treatment.
* The patient has an ODQ total score ≥50 at baseline, while on SSRI/SNRI monotherapy (prior to switch).
* The patient answered "Yes "to the screening question on emotional effects.

Exclusion Criteria:

- The patient has a significant risk of suicide according to the investigator's clinical judgment or has made an actual suicide attempt in the previous 6 months prior to Baseline

Other in- and exclusion criteria may apply
Exercise Training to Lose Weight in Obese Asthmatics

Obese asthmatics have more severe symptoms, reduced lung function, poorer quality of life and a reduced response to inhaled corticosteroid medication compared to non-obese asthmatics. In addition, the impact of a weight-loss program on clinical control and psychological outcomes has been poorly demonstrated and the effect of exercise training remain unknown. The investigators aim to investigate the effect of exercise training in a weight-loss program on asthma clinical control (primary outcome), health factors related to quality of life and psychosocial symptoms (secondary outcomes) in obese patients with moderate-to-severe persistent asthma. Physical activity, inflammatory profiles and sleep disorders will also be evaluated. The investigators' hypothesis is that exercise as part of a weight-loss program is more effective to lose weight and improve asthma control, quality of life and psychosocial symptoms in obese asthmatics.

This is a randomized, controlled and single blinded trial. Fifty-four asthmatic adults will be randomly assigned into two groups: DBG (dietary and behavioral support group) or DBE (similar to DBG + exercise training). Both groups will complete a weight-loss program based on dietary and behavioral therapy. In addition, DBE will perform a training program based on aerobic and resistance training whereas DBG will perform a breathing and stretching program. Interventions will be performed twice a week for 3 months, 60 minutes each. The data normality will be analyzed by Kolmogorov-Smirnov, the variables obtained before interventions will be compared with the Student t-test or Mann-whitney U-test. Comparisons of the initial and final data on outcomes will be analyzed with repeated measures ANOVA with appropriate post hoc of Bonferroni. The significance level will be set to 5% for all tests.

Eligibility Criteria:
Inclusion Criteria:

* Asthma moderate and severe
* Asthma will diagnosed (Global Initiative for Asthma -GINA)
* Body Mass Index between 35 kg/ m2 and 39,9 kg/m2
* Sedentary
* Medical treatment, for at least 6 months
* Clinically stable (i.e., no exacerbation or medication changes for at least 30 days)

Exclusion Criteria:

* Cardiovascular, musculoskeletal or other chronic lung diseases
* Active Cancer
* Pregnant
* Weight loss more than 5 % in the preceding 6 months
* Using weight-loss medications
* History of bariatric surgery, uncontrolled hypertension or diabetes
* Using overnight continuous positive airway pressure
* Lactating
* Current or ex-smoker
Maintenance of Vitamin D Level by UVB Radiation

The purpose of the study is to determine the frequency of UVB radiations necessary to maintain the Vitamin D level during winter time.

The work is addressing vitamin D production after UVB exposure and explore how much UVB radiation which is necessary to maintain a sufficient vitamin D level during the winter period in Denmark. 4 different UVB exposure times and 2 different UVB doses to 2 different body surface areas.

Eligibility Criteria:
Inclusion Criteria:

* 18-65 years
* Healthy

Exclusion Criteria:

* Sun bed use
* Holiday or business travel south of 45 degrees latitude during trial
* Illness
* Drug addiction
* Pregnancy
* Lactating
Brilliant Study: Assessing Cognition in Myeloma Patients Undergoing Transplant

The overall objectives in this study are to identify patterns of cognitive impairment pre- and post-transplant, to assess the similarities of scores of the three cognitive assessments in myeloma patients who undergo autologous stem cell transplant, and to determine if patients prefer the self-assessment, Self-Administered Gerocognitive Exam (SAGE) or the healthcare applied Montreal Cognitive Assessment (MoCA) assessment.

The overall objectives in this study are to identify patterns of cognitive impairment pre- and post-transplant, to assess the similarities of scores of the three cognitive assessments in myeloma patients who undergo autologous stem cell transplant, and to determine if patients prefer the self-assessment, Self-Administered Gerocognitive Exam (SAGE) or the healthcare applied Montreal Cognitive Assessment (MoCA) assessment.

Eligibility Criteria:
Inclusion Criteria:

* Patients with multiple myeloma
* Patients who will undergo pre-transplant evaluation with intentions to proceed to autologous stem cell transplant after stem cell collection.
* Patients willing and able to understand and sign an informed consent form
* Patients 18 yrs of age or older

Exclusion Criteria:

* Patients with unstable psychiatric illness within the past 3 months of study enrollment.
* Patients who are considered unable to perform study evaluations at the investigator's discretion.
* Patients who are unable to read. (If patients require reading glasses, they must be worn at time of test.)
* Patients who do not proceed to stem cell transplant within 60 days of stem cell collection will be excluded from study.
* Patients who receive more than one cycle of chemotherapy between the time of stem cell collection and transplant will be excluded from study.
Focus on the Humeral Component Following Reverse Shoulder Arthroplasty

Reverse total shoulder arthroplasty has been widely used in the treatment of rotator cuff arthropathy. Follow-up has historically focused on the glenoid component because of problems with fixation and scapular notching leading to functional failure. Since several patients have shown cortical thinning of the proximal lateral humeral cortex during follow-up, further research is recommended to evaluate the cause and clinical impact of these radiographic changes. The goal of this study is to collect long-term radiographic and clinical data in order to facilitate the identification of risk factors.

Reverse total shoulder arthroplasty has been widely used in the treatment of rotator cuff arthropathy. Follow-up has historically focused on the glenoid component because of problems with fixation and scapular notching leading to functional failure. Fixation of the humeral component has evolved from cemented to mostly uncemented with diaphyseal of metaphyseal press-fit stems. Bony changes around the stem reflect the bone-implant interface; research to evaluate and interpret these changes is insufficient at this moment. Since several patients have shown cortical thinning of the proximal lateral humeral cortex during follow-up, further research is recommended to evaluate the cause and clinical impact of these radiographic changes. The goal of this study is to collect long-term radiographic and clinical data in order to facilitate the identification of risk factors.

Eligibility Criteria:
Inclusion Criteria:

* Minimum age of 18 years old
* Total shoulder replacement using a reverse type implant (Delta Xtend or Zimmer TM) between 2007 and 2017 in UZ Leuven
* Primary indication for surgery is rotator cuff arthropathy
* Informed consent obtained

Exclusion Criteria:

* Total shoulder replacement in post septic arthritis.
* Total shoulder replacement in post-instability arthritis.
* Revision total shoulder arthroplasty.
* Posttraumatic total shoulder arthroplasty (after failed index operation)
Long-term Prognosis for Non-functional Neuroendocrine Tumors of the Pancreatic Body and Tail ≤ 3cm

This study aims to quantify the malignant potential of non-functional neuroendocrine tumors of the pancreatic body and tail ≤ 3 cm by collecting real-world data from large pancreatic centers across the country, and to evaluate the appropriateness of parenchyma-sparing resection and oncologic resection.

According to epidemiological investigations, the incidence of neuroendocrine tumors has increased 6.4-fold (6.98 per 100,000) . There is controversy in the latest guidelines regarding the management of sporadic non-functional pancreatic neuroendocrine tumors (pNETs) ≤ 2 cm, including follow-up and the choice between parenchyma-sparing resection (PSR) and oncologic resection (OR) . Although pNETs are generally considered indolent tumors, current experience suggests that 9.5%-12.3% of pNETs ≤ 2 cm may have lymph node metastasis, and nearly 20% of resected tumors exhibit one or more invasive features. Awareness of surgical treatment for these patients has been increasing gradually. However, there is no clear recommendation for the choice of surgical approach, and if OR is routinely performed, its prognostic value is unclear and there may be a risk of overtreatment.

The advantages of PSR include preservation of both endocrine and exocrine pancreatic function. However, the main oncological limitations of these techniques are inadequate surgical margin clearance and the risk of lack of lymph node dissection. A recent retrospective analysis of prospective databases from four large pancreatic surgery centers showed that for ≤ 3 cm non-functional pNETs, PSR or lymph node-preserving resection had less blood loss, shorter operation time, lower complications rate, and similar long-term oncological outcomes compared to OR. However, this study did not differentiate the tumor locations, as pNETs in the pancreatic head and body/tail have different lymphatic drainage patterns and surgical approaches. Furthermore, the study also showed significant differences in the proportion of PSR and the rate of positive lymph nodes between tumors located in the pancreatic head and those in the body/tail.

The ability of existing literature to provide reliable guidelines for pNETs is limited by the low incidence of the disease and short follow-up times. This study aims to quantify the malignant potential of pNETs of the pancreatic body and tail ≤ 3 cm by collecting real-world data from large pancreatic centers across the country, and to evaluate the appropriateness of PSR and OR.

Eligibility Criteria:
Inclusion Criteria:

* Non-functional neuroendocrine tumors of the pancreatic body and tail ≤ 3 cm.

Exclusion Criteria:

* Presence of liver or distant metastasis.
* Presence of concomitant malignancy.
* Multifocal or recurrent disease.
* Presence of hereditary syndrome (MEN1, VHL, NF).
* Presence of symptoms (specific symptoms of clinical syndromes suspected to be related to excessive secretion of bioactive compounds).
* History of preoperative antitumor therapy.
* Loss to follow-up.
Study of ME-401 in Subjects With Relapsed or Refractory Indolent B-cell Non-Hodgkin's Lymphoma

The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of ME-401 in the treatment of Japanese participants with Relapsed or Refractory indolent B-Cell Non-Hodgkin's Lymphoma and to continue administraion of ME-401 to patients with relapsed or refractory B-cell NHL with collecting safety information


Eligibility Criteria:
Inclusion Criteria:

\[Phase 1 study (DLT evaluation)\]

* Patients aged 20 years or older at the submission of the written informed consent form
* Patients with relapsed or refractory B-cell NHL
* Patients who have not undergone phosphatidylinositol 3-kinase inhibitor (PI3K) to date.
* Patients who have undergone Bruton's tyrosine kinase (BTK) inhibitors and have had no exacerbation during the use of BTK inhibitors.
* Patients with ECOG PS 0 or 1.

Exclusion Criteria:

\[Phase 1 study (DLT evaluation)\]

* Patients who underwent any major surgical treatment within 4 weeks prior to the initiation of the investigational product.
* Patients with poorly controlled diseases. The followings are the examples but the diseases will not be limited to those.
* Patients in whom any of HBV antigen/antibody, HCV antibody, HIV antibody or HTLV-1 antibody will be positive at screening test.
* Patients with active interstitial lung disease or a history thereof.
* Patients who have received the investigational products other than ME-401, systemic chemotherapy or radiotherapy within 4 weeks prior to the initiation of ME-401.
Stress Recovery Program FOREST for Healthcare Staff

The aim of the study is to assess the efficacy of an internet-based stress recovery intervention among healthcare staff during COVID-19 pandemic.

Intervention is going to take the form of an internet-based stress recovery intervention consisting of six modules. The themes include introduction, psychological detachment, distancing, mastery, control, and keeping the change alive. These themes were chosen after considering topics that might be the most useful for healthcare staff experiencing high levels of stress. Each module consists of psychoeducation and exercise parts. Psychologist provide individual feedback on completed exercises as well as can be reached on demand.

The effect of the intervention will be compared against a waiting list control group. Intervention is in Lithuanian.

Eligibility Criteria:
Inclusion Criteria:

* at least 18 years old;
* comprehending Lithuanian language;
* access to internet;
* high levels of stress.

Exclusion Criteria:

* acute psychiatric crisis;
* high suicide risk;
* interpersonal violence;
* alcohol / drug addiction.
A Phase 2b Clinical Study With a Combination Immunotherapy in Newly Diagnosed Patients With Glioblastoma

The purpose of this study is to assess progression-free survival (PFS) and overall survival (OS) in newly diagnosed Glioblastoma (GBM) participants treated with IGV-001 as compared with placebo.


Eligibility Criteria:
Key Inclusion Criteria:

* Has a Karnofsky performance scale (KPS) score ≥ 70 at screening
* Has a new diagnosis of GBM (WHO GRADE III or Grade IV GBM) based on the treating neurosurgeon's best clinical judgement
* Has a diagnostic contrast-enhanced magnetic resonance imaging (MRI) scan with fluid attenuated inversion-recovery (FLAIR) sequence of the brain at screening. Participants must have a confirmed measurable disease pre-operatively with at least 1 lesion measuring a total bi-perpendicular product of 4 centimeter square (cm\^2) in 2 different planes (axial, sagittal, or coronal)
* The tumor must be located in the supratentorial compartment
* Has adequate bone marrow and organ function at screening

Key Exclusion Criteria:

* Has bi-hemispheric disease, multicentric disease, or disease burden involving the brain stem or cerebellum based on MRI post-gadolinium enhancement
* Has received any previous surgical resection or any anticancer intervention for glioma
* Has any history of glioma, a concurrent malignancy, or malignancy within 3 years of randomization, unless definitive therapy is completed, with the exception of basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the cervix or breast that has completed curative therapy
* Has any severe immunocompromised condition (eg, human immunodeficiency virus (HIV) with a cluster of differentiation \[CD\] 4+ cell count \<200\*10\^6/liter \[L\]) or any active uncontrolled autoimmune disease (eg, Crohn's disease)
* Has an active cardiac disease or a history of cardiac dysfunction
* Is receiving any other investigational agent(s) or has received an investigational agent within 30 days or 5 half-lives of investigational agent use, whichever is longer, prior to screening
* Is partaking in another interventional study. Participants who are partaking in an observational study are eligible
* Has received a live vaccine within 30 days of screening
* Has active and uncontrolled/untreated hepatitis B virus (HBV), hepatitis C virus (HCV), HIV, or any other active infections that, in the Investigator's opinion, would impair or prohibit a participant's participation in this study.
* Is receiving treatment with Tumor Treating Fields or Optune®
Heliox in Experimental Upper Airway Obstruction

Currently it is common medical wisdom that HELIOX (mixture of Helium in Oxygen) with a fraction of Helium below 60% is not effective in reducing airway obstruction. The investigators test the hypothesis that HELIOX with a fraction of Helium below 60% is still effective in relieving airway obstruction in a double-blind, randomized and controlled clinical PoC study with experimental upper airway obstruction.

HELIOX is a mixture of Helium and Oxygen. It is a therapeutic modality that can improve upper and lower airway obstruction. The lower density of Helium can help to relieve airway obstruction and is known to lower the work of breathing. The fraction of Helium (FHe) in HELIOX should be maximized (e.g. up to a fraction of 79% with 21% of oxygen added) in order to achieve optimal anti-obstructive outcome and according to the literature a FHe below 60% renders HELIOX ineffective.

Objective: We conducted an investigator-initiated trial using different mixtures of Helium and Oxygen in 44 healthy volunteers in a randomized and double-blinded fashion.

Methods: After an adjustment phase the subjects were breathing through two different external resistors (intratracheal tube with inner diameter of either 4.0mm or 5.0mm) while gas of different composition (medical air with 79% Nitrogen and 21% Oxygen as control gas and HELIOX with a fraction of either 25%, 50% or 75% Helium in Oxygen, respectively) was provided in a blinded and random fashion. A crossover design was used so that every subject was exposed to every HELIOX gas mixture. Subjects were asked to score their degree of dyspnea after breathing different gas mixtures for 2 minutes intervals. In addition the variability of different hemodynamic parameters was assessed (continuous non-invasive blood pressure (systolic, diastolic and mean blood pressure), impedance cardiography (stroke volume and cardiac output), ECG (heart rate variability)) were assessed non-invasively and used to detected a change in the degree of airway obstruction in respect to the added load and the gas mixture.

Eligibility Criteria:
Inclusion Criteria:

* Volunteers of both sexes were recruited via posting in student forum of University of Witten/Herdecke
* Willingness to spend about 2h in the clinical exp. lab.

Exclusion Criteria:

* Acute airway infection
* History of asthma
* Smokers
* Pregnancy
* Abnormal lab. screen with liver function tests, Creat./BUN, CBC, blood glucose
* Anxiety or mood disorder
* Any chronic disease (incl. lung \& heart disease, cancer, endocrine disorder)
* Mental retardation