cyrilzakka/clinical-trials huggingface dataset:
Evaluation of Iron Supplementation During Darbepoetin Alfa Treatment in Prophylaxis of Severe Anaemia Chemo-Induced

The purpose of this study is to evaluate the response rate obtained in an heterogeneous oncologic population treated by chemotherapy, and either by Darbepoetin alfa classic treatment or by association of Darbepoetin alfa -ferric saccharose systematic supplementation, administered concomitantly with chemotherapy.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* Well-informed written consent, signed by the patient
* Patient picked up for solid tumor treatment, whichever the localization, with or without metastasis
* Patient revealing, before or during chemotherapy, a moderate anemia, that means: Men: 9\<Hb\<12 g/dl; Women: 9\<Hb\<11 g/dl.
* Patient for who at least four chemotherapy cycles are planed (eight in case of weekly chemotherapy) after inclusion in the study
* Patients with life expectancy higher than three months
* Patient with general conditions compatible with the study's follow-up

Exclusion Criteria:

* Contra-indication for Venofer
* Anemia which can have curative treatment
* Bloody transfusion during the previous four weeks
* Documented or suspected medullary invasion
* Uncontrolled arterial hypertension
* Acute bacterial infection
* Transferrin saturation's coefficient
* Pregnancy
* Ferric salts oral treatment interrupted since less than one week
* Patient with bad french language's comprehension
* Patient with a major psychiatric pathology
* Patient under guardianship, trusteeship or justice safeguard
The Prevalence of Lower Urinary Tract Symptoms (LUTS) in Poland

The first large population-based study to evaluate lower urinary tract symptoms (LUTS) in Poland. The study objective is to assess the prevalence and bother of LUTS in the population aged ≥40 years in Poland.

The first large population-based study to evaluate lower urinary tract symptoms (LUTS) in Poland. The study objective is to assess the prevalence and bother of LUTS in the population aged ≥40 years in Poland.

This study will be conducted as a telephone survey with assessment of LUTS using a standardized protocol, which included the International Prostate Symptom Score (IPSS) and, for overactive bladder (OAB), the OAB-V8 questionnaire. Participants will be asked to rate how often they experienced individual LUTS and the degree of associated bother.

The study will be performed in a representative group of Polish population (n = 6,000) covering all geographic regions of Poland (defined by the Central Statistical Office of Poland).

Eligibility Criteria:
Inclusion Criteria:

Age \>40

Exclusion Criteria:

Age \<40 Pregnancy Urinary tract infection in the past 4 weeks
Chinese Registry of Assisted Embolization for Ruptured Wide Necked Intracranial Aneurysm Using LVIS Stent

This study aims to investigating the efficacy and safety of low profile visualized intraluminal support (LVIS) stents for the treatment of ruptured intracranial saccular aneurysms. The follow-up duration is 1 year.

This study is a prospective multi-centre observational single-arm clinical trial, aiming to investigating the efficacy and safety of low profile visualized intraluminal support (LVIS) stents combined with coils for the treatment of ruptured intracranial saccular aneurysms. As the protocol, clinical follow-up at 30 days (±7 days) after procedure, DSA or MRA follow-up at 6 months (±30 days) after procedure, and clinical follow-up at 1 year (±30 days) after procedure was conducted for each patient. The primary end-points include major adverse events (cerebral infarct and death) in 30 days post-procedure, complete occlusion rate at 6 months (180±30d) follow-up, and modified Rankin Score (mRS) at 1 year follow-up. The secondary end-points were immediate technical success (successful device placement) rate, immediate complete occlusion rate, recurrence rate at 6 months (180±30d) follow-up and in-stent stenosis or obliteration rate at 6 months (180±30d) follow-up. Duration of this study is 2 years.

Eligibility Criteria:
Inclusion Criteria:

* Patients meeting all the following criteria will be enrolled:

  1. Patients of the age 18-75 years old.
  2. Patients diagnosed with ruptured intracranial saccular aneurysms via CTA, MRA or DSA.
  3. Patients treated with LVIS stents combined with coils.
  4. Patients willing to follow the clinical trial instructions and receive follow-up assessment.
  5. Patients accepting to participate to the study and sign the consent forms.

Exclusion Criteria:

* Patients meeting any following criterion will be excluded

  1. Patients without proper artery approach.
  2. Patients with AVM.
  3. Patients with a fusiform or dissecting aneurysm.
  4. Patients with a recurrent aneurysm.
  5. Patients treated with a LVIS stent without coils.
  6. Patients in poor clinical status, with mRS ≥4.
  7. Patients with life expectancy less than 12 months.
  8. Patients participated in other clinical trial, while has not reach the primary endpoint.
  9. Patients can not accept anti-platelet regimen.
  10. Patients allergic to contrast agent or intolerable.
  11. Patients whom the researchers consider should not participate in or continue this clinical trial.
Unilateral Massage as a Potential Treatment for Depression

In depression, EEG studies have shown frontal asymmetry with relatively lower activity in the left hemisphere. In this study a moderate pressure massage will be conducted by a trained professional on one of the following conditions: the right side of the body, the left side of the body, or both sides of the body (a traditional massage on the back of the body) while EEG measurements of brain activity are recorded and mood ratings are obtained.


Eligibility Criteria:
Inclusion Criteria:

* Medically and mentally healthy, right-handed participants will be eligible for participating in this study. The age range for enrollment in the study is not restricted by any variables but will be set between 18 and 50 years of age.

Exclusion Criteria:

* Left-Handed subjects, persons suffering acute or chronic mental illnesses and chronic illnesses (including autoimmune illnesses).
Robot-assisted D2 Distal Gastrectomy Following Neoadjuvant Chemotherapy for Locally Advanced Gastric Cancers

To evaluate the safety of robot-assisted radical gastrectomy with D2 lymph node dissection in postoperative complications in patients with neoadjuvant chemotherapy for gastric cancer (cT3-4a, N+, M0).


Eligibility Criteria:
Inclusion Criteria:

Age from over 18 to under 75 years; Primary gastric adenocarcinoma (including pap, tub, muc, sig, and por) confirmed pathologically by endoscopic biopsy; cT3-4a, N-/+, M0 according to the AJCC 8th Cancer Staging Manual; Without peritoneal metastasis (examined by laparoscopic examination); Radical resection (R0) through distal subtotal gastrectomy with D2 lymphadenectomy is anticipated; Performance status 0 or 1 (Eastern Cooperative Oncology Group) ; ASA (American Society of Anesthesiology) score ≤ 3;

Normal hemodynamic indices:

Blood cell count: HB ≥ 90g/L, ANC ≥ 1.5×109/L, PLT ≥ 80×109/L; Liver and renal function: BIL\<1.5 times of the upper limit of normal reference values, ALT and AST\<2.5 times of the upper limit of normal reference values, and Crea≤1 time of upper limits of normal reference values.

Therapeutic response rating after neoadjuvant chemotherapy is CR, PR, SD, or Therapeutic response rating after neoadjuvant chemotherapy is PD, tumor is expected to have radical resection; Subjects are still willing to continue participating in this clinical trial.

Exclusion Criteria:

History of upper abdominal surgery (include endoscopic mucosal resection or endoscopic submucosal dissection, except for laparoscopic cholecystectomy); History of acute pancreatitis; Enlarged or bulky regional lymph node (diameter\>3cm) by imaging exam; Patients have received neoadjuvant therapy prior to screen work; History of other malignant disease within the past five years; History of cerebrovascular accident within the past six months; History of continuous systematic administration of corticosteroids within the past month; Scheduled simultaneous surgery for other disease; Emergency surgery due to complication (bleeding, obstruction or perforation) caused by gastric cancer; Pyloric obstruction; FEV1\<50% of predicted value; Women who are pregnant or lactating at the time of screening; Severe mental disorder; Participating in other clinical studies; Refused to sign the informed consent;

Therapeutic response rating after neoadjuvant chemotherapy is PD, involvement of adjacent structures(T4b), distal metastasis(M1), or enlarged or bulky regional lymph node (diameter\>3cm) by preoperative imaging Patients cannot complete 3 cycles of chemotherapy due to intolerance; After 3 cycles of neoadjuvant chemotherapy, patients cannot tolerate surgery due to severe adverse reactions, or ASA score ≥ 4 ; Patients undertake emergency operation due to tumor bleeding, perforation or obstruction during chemotherapy; After signing the informed consent, the patient withdraws from this clinical trial.
A Trial Evaluating Concurrent Whole Brain Radiotherapy and Iniparib in Multiple Non Operable Brain Metastases

Recent pre-clinical and clinical data have indicated that BSI-201 does not possess characteristics typical of the PARP inhibitor class. Based on the results from in vitro and in vivo studies, this trial aims to evaluate the combination of BSI-201 concomitantly with radiotherapy in patients who present with multiple non operable brain metastases. As radiotherapy is a local treatment targeting only the tumor, and because the molecule BSI-201 has shown no major toxicity against tissues without DNA alterations, the proposed combination is expected to provide tumor-selective therapy and leading to a clinical benefit improvement.

Primary objective is to determine the recommended phase II dose (RP2D) and evaluate acute toxicity (CTC-AE v4.0 grading scale) of concurrent administration of whole brain radiotherapy (WBR) and a small molecule BSI-201 in non operable brain metastases.


Eligibility Criteria:
Inclusion Criteria:

* Non operable brain metastases from any type of cancer (≥ 2)
* At least one measured brain target available ≥ 1 cm (T1-weighted sequences with contrast application MRI)
* No stereotaxie indication
* Any anterior treatments for systemic disease (any chemotherapy at any line) are accepted but have to be interrupted at least 15 days before and up to 30 days after the present protocol
* No extra-brain disease or stabilized since at least 1 month
* Aged ≥ 18 years old
* KPS \> 70 (RPS class I or II)
* Adequate bone marrow function: WBC ≥ 3.5 x 109/L, ANC ≥ 1.5 x 109/L, Platelets ≥ LLN, Hb \> 10g/dL,
* Adequate renal function: serum creatinine ≤ 1.5 × ULN and blood urea nitrogen ≤ 25 mg/dL
* Male or female patient using adequate contraceptive method
* Women of childbearing potential must have a negative serum or urine pregnancy test within 3 days prior to the start of treatment
* Informed and signed consent
* Able to be followed according to the terms of the protocol
* Affiliated to the French National social security

Exclusion Criteria:

* Anterior treatment for brain metastases (surgery, radiosurgery, stereotaxie)
* Leptomeningeal metastases
* Inclusion in another protocol within 30 days
* Brain metastases with severe intracranial hypertension clinical signs
* Other cancer except the known primary tumor or in situ cervix cancer or basocellular carcinoma
iPhone App Compared to Standard RR-measurement

In this Trial we compare a new application (App) running on an iPhone (Apple inc., Model 4S) to determine systolic blood pressure (RR) and compare it to conventional oscillometric measurements using an Omron HBP-1300-E Pro device. We will include 1000 participants and perform seven repetitive blood pressure measurements (3 iPhone, 4 Omron) in each person. Primary parameter will be the absolute difference (Delta) between the correlating blood pressure measurements in mmHg.

Participants will be asked for consent at the University Hospital Basel at random based on availability. Recruitment is not limited to patients. After consenting patients will accompanied to a RR-measurement unit, positioned in a chair and kept at rest for 4 minutes. Then 7 blood pressure measurements at the same arm will be performed (Cuff/iPhone/Cuff/iPhone/Cuff/iPhone/Cuff). The Cuff measurement results will be documented in the source documents (mmHg) and transferred to a trial database. The iPhone data will be transferred with patient ID to "Preventicus" for calculation of the systolic blood pressure values (mmHg) based on the pulse waves recorded by transillumination of the index fingers of the participants. "Preventicus" will have NO access to the Cuff-measurement data. Then this data will be retransferred to the trial site and merged with help of the patient ID. Absolute and relative differences of the measured (Omron) and calculated (iPhone) systolic blood pressure values (mmHg) for will be calculated and published.

A subgroup of 40 participants will be evaluated in a highly standardized fashion according the ESH (European Society Hypertension) guidelines for validation studies. These data will then be published separately for validation purposes.

Eligibility Criteria:
Inclusion Criteria:

* able to give informed consent
* in Sinus rhythm
* no anatomical limitation to take blood pressure

Exclusion Criteria:

* Atrial fibrillation
* Dialysis shunt
DIVIT Study Diet and Vitamin Supplementation in Patients With a Neuroendocrine Tumor

This study aims to investigate if the proportion of neuroendocrine tumor (NET) patients with normal vitamin values can be increased, with vitamin suppletion and a personalized diet, Effects of the intervention will be evaluated by quantitative analysis of blood and urine and questionnaires. The measurements, will be performed at baseline (t=0), after 4 weeks (t=4) and after 18 weeks at end of study (t=18). Furthermore at t=18 a semi-qualitative interview will be performed.

Objective:

This study aims to investigate if the proportion of NET patients with normal vitamin values can be increased, with vitamin suppletion and a personalized diet.

Methods:

This is a single center 18-week open-label, non-comparative, single-arm, intervention study. After inclusion and the first measurements, adult patients with metastasized or irresectable NET will continue with four weeks of standard treatment. After these four weeks participants with vitamin values below normal will get vitamin suppletion for each deficient vitamin and all participants will get the dietary intervention during 14 weeks. Effects of the intervention will be evaluated by quantitative analysis of blood and urine and questionnaires. The measurements, including; baseline characteristics, quantitative analysis of blood and urine and questionnaires will be performed at baseline (t=0), after 4 weeks (t=4) and after 18 weeks at end of study (t=18). Furthermore at t=18 a semi-qualitative interview will be performed.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients aged ≥ 18 years
* NET-patients with serotonin producing or non-serotonin producing tumors, with gastro-intestinal, pancreatic, bronchopulmonary or unknown primary tumor site and with metastasized or irresectable disease
* Ability to comprehend Dutch (both reading and writing).
* Written informed consent provided.
* Use of somatostatin analogue for \> 6 months.

Exclusion Criteria:

* Estimated life expectancy less than 6 months.
* Patients who have a history of another primary malignancy, except for radical and adequately treated malignancies from which the patient has been disease free for ≥ 1 year.
* Major abdominal surgery during study period.
* Patients already participated in the DIVIT-pilot study
* Known hypersensitivity of (components of) somatostatin analogue
Unity Cures Future (UCF) Biobank

Research scientists of the University of Central Florida College of Medicine (COM) and Burnett School of Biomedical Sciences (BSBS) conduct laboratory studies in biomedical and translational medical research for the purpose of understanding human disease and developing innovative methods for diagnosing, measuring, or treating disease or disease symptoms. The key research divisions are cancer, cardiovascular, immunity and pathogenesis, neuroscience, and molecular microbiology.

The goal of this human tissue repository protocol is to aggregate resources and streamline the acquisition of human tissue. It is optimal for the advancement of biomedical and translational medical research that the human tissue be received under one protocol by the College of Medicine's the Clinical \& Aerospace Health Research team and transferred to the COM/BSBS research scientists for laboratory testing.

This aggregation of efforts and resources through a human tissue repository protocol allows for:

1. Improvements in biomedical and translational medical research by availability of viable human tissues.
2. Reduced recruitment and enrollment burden on the Clinical \& Aerospace Health Research team and the participants via pooled recruitment. Further, participants will only need to provide one informed consent. Received human tissue may be used for multiple protocols.
3. Improved data for analysis as participants will complete an online case report form containing basic demographic data; planned location and date of upcoming surgery or procedure; diagnosis; name of surgeon/doctor for the planned surgery or procedure; type of surgery or procedure; medical data; medical history; and surgery history.

Eligibility Criteria:
Inclusion Criteria:

1. be able to read and understand English
2. scheduled for a surgery or procedure that will result in the removal of human tissue.

Exclusion Criteria:

1. Pregnant
2. unable to provide an informed consent
3. unable to understand or read in English
4. minors (ages under 18)
5. prisoners
A Clinical Study of 8MW2311 in Subjects With Locally Advanced or Metastatic Solid Tumors

This study is a Phase 1/2, first-in-human, open-label, dose-escalation and cohort expansion study designed to characterize the safety, tolerability, pharmacokinetics, pharmacodynamics, preliminary antitumor activity and immunogenicity of 8MW2311 administered by intravenous (IV) infusion.


Eligibility Criteria:
Inclusion Criteria:

1. Male or female, aged≥18 years old;
2. Histologically or cytologically confirmed locally advanced or metastatic solid tumor;
3. Subjects must have measurable disease according to RECIST (version 1.1)；
4. Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1;
5. Life expectancy \>3 months;
6. Adequate organ performance based on laboratory blood tests;
7. Sexually active fertile subjects, and their partners, must agree to use methods of contraception during the study and at least 6 months after termination of study therapy；
8. Ability to understand and the willingness to sign a written informed consent document；

Exclusion Criteria:

1. History of other malignancy within 3 years before the first dose of study drug.
2. History of IL-2 or IL-2 analogues anticancer therapy.
3. Chemotherapy or radiotherapy within 21 days prior to the first dose of study drug, or any other anticancer therapy within 14 days prior to the first dose of study drug.
4. Major surgery within 28 days prior to first dose of study drug.
5. Any live vaccines within 28 days before first dose of study drug or during the study.
6. Systemic glucocorticoids or other immunosuppressants received within 14 days before first dose of study drug.
7. Toxicity related to preexisting treatment ≥Grade 2.
8. Central nervous system metastasis and/or cancerous meningitis.
9. Inadequately controlled body cavity effusions.
10. Interstitial pneumonia or interstitial lung disease, other pneumonia history or active pneumonia that may interfere with the judgement of immune-related pulmonary toxicity.
11. Active autoimmune disease, or autoimmune diseases history with recurrence possibility.
12. Clinically significant cardiac or cerebrovascular disease.
13. Use of any investigational drug within 28 days prior to the first dose of study drug.
14. Known sensitivity to any of the ingredients of the study drug.
15. Known active hepatitis B or C infection, or other serious infection.
16. History of drug abuse or drug addiction.
17. Pregnancy or lactation.
18. Other disease or condition which may put the subject at significant risk.
The Efficiency of Anterior Repositioning Splint for the Management of Temporomandibular Joint Dysunction

Intra-articular temporomandibular disorders are often related to pain in the area of temporomandibular joint, ear and temple. The aim of the study was to investigate the efficiency of anterior repositioning splints for the management of pain related to temporomandibular joint disc displacement with reduction.

The research material consisted of 112 patients, aged 24 to 45 years, of both genders, who reported to the treatment in Consulting Room of Temporomandibular Joint Dysfunctions at the Jagiellonian University in Cracow, between 2014-2016, due to the pain and clicking of temporomandibular joints with comorbid hypertension of masticatory muscles. Subjects were examined according to the Diagnostic Criteria for Temporomandibular Disorders protocol and after inclusion with painful disc displacement with reduction and masticatory muscle contracture assigned randomly to the study or control group (56 patients in each). In the study group was used the anterior repositioning splint on the lower arch for 20 hour usage per 4 months. In the control group a non-invasive therapy was applied using biostimulation laser in the form of 12 session, performed every second day, on the area of the temporomandibular joints with opened mouth and performing muscles self-exercises with a dominant protrusive position of the mandible. Pain intensity was evaluated using verbal numerical rating scale (VNRS) immediately before the treatment and then after 4 and 16 weeks. The obtained data were analyzed using U Mann-Whitney test (p ≤ 0,005).

Eligibility Criteria:
Inclusion Criteria:

1. unilateral or bilateral presence of clicking, popping and/or snapping noise(s) detected with palpation during opening or closing or lateral or protrusive movements in TMJ(s),
2. in the previous 30 days, any TMJ noise(s) present with jaw movement or function,
3. unilateral or bilateral pain in the area of temporomandibular joint,
4. presence of masticatory muscles contracture,
5. full dentition or single tooth loss,
6. good general health,
7. positive mandible protrusion test,
8. no contraindications for laser therapy
9. patient consent to be involved in the study.

Exclusion Criteria:

1. partial tooth loss or edentulism,
2. contraindications for laser therapy
3. absence of appropriate symptoms
4. absence of consent to be involved in the study
Safety and Efficacy of SAF312 in Patients With Neurogenic Detrusor Overactivity Due to Spinal Cord Lesions

This study will assess the safety, tolerability and efficacy of SAF312 in patients with overactive bladder disease due to spinal cord lesions. The overactive bladder of patients who qualify for this study is insufficiently managed by antimuscarinic therapy, or patients poorly tolerate the treatment with antimuscarinic drugs. The efficacy of SAF312 will be primarily determined via urodynamic measurements.


Eligibility Criteria:
Inclusion Criteria:

* Patients with neurogenic detrusor overactivity due to spinal cord lesions
* Patients are inadequately managed by antimuscarinic medication and present with a cystometric bladder capacity of max. 400 mL

Exclusion Criteria:

* Chronic inflammation such as interstitial cystitis, bladder stones, hematuria of unknown origin, previous pelvic radiation therapy or previous or current malignant disease of the pelvic organs
* Pelvic or genitourinary tract anomalies including surgery or bladder disease other than detrusor overactivity impacting on bladder function