cyrilzakka/clinical-trials huggingface dataset:
MP0250 DARPin® Protein Plus Osimertinib in Patients With EGFR-mutated NSCLC

The purpose of this study is to assess the anti-tumor efficacy, safety, tolerability, pharmacokinetics (PK), immunogenicity and biological activity of the MP0250 DARPin® drug candidate in combination with osimertinib orally once daily (o.d.), when administered to patients with EGFR mutated, advanced, non squamous NSCLC after tumor progression on osimertinib and on or after the most recent therapy.

MP0250 is a multi-DARPin® protein with three specificities, able to simultaneously neutralize the activities of vascular endothelial growth factor (VEGF) and hepatocyte growth factor (HGF) and also to bind to human serum albumin (HSA) to give an increased plasma half-life and potentially enhanced tumor penetration.


Eligibility Criteria:
Inclusion Criteria:

1. Histologically confirmed metastatic or unresectable locally advanced non-squamous NSCLC with documented EGFR mutation-positive disease
2. Radiologically documented disease progression on previous osimertinib treatment.
3. Radiologically documented disease progression on or after most recent antitumor therapy.
4. Measurable disease according to RECIST 1.1.
5. Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 2.
6. Men and women ≥18 years old on the day of signing informed consent.
7. Adequate hematological, hepatic and renal function prior to first dose
8. Serum albumin concentration ≥30 g/L
9. Potassium and magnesium within normal range

Exclusion Criteria:

1. Necrotic tumors or tumors close to large blood vessels that may impose an increased bleeding risk when treated with anti-VEGF agents.
2. Second malignancy that is currently clinically significant or required active intervention during the period of 12 months prior to Screening, except early stage non-melanoma skin cancer treated with curative intent.
3. Known pre-existing interstitial or inflammatory lung disease.
4. Clinical signs of or documented leptomeningeal carcinomatosis. Features such as headache, nuchal rigidity, and photophobia may indicate meningeal involvement.
5. Known brain metastases who are clinically unstable
6. Prohibited anti-NSCLC therapies and not having recovered from related AEs to Common Terminology Criteria for Adverse Events (CTCAE) Grade ≤1
7. Any investigational drug within 28 days prior to study treatment.
8. Current participation in any other interventional clinical study (except survival follow up).
9. Neuropathy as residual toxicity after prior antitumor therapy Grade \>2
10. Patients taking medications that have the potential to prolong the QT interval
11. Significant cardiac abnormalities
12. Uncontrolled hypertension
13. Significant risk for bleeding
14. Active or recent thrombolic events
BlueWind Medical System for the Treatment of Patients With OAB

BlueWind system safety and performance in treatment of patients diagnosed with overactive bladder (OAB)

BlueWind Medical system safety and performance in treatment of patients diagnosed with overactive bladder (OAB)

Eligibility Criteria:
Inclusion Criteria:

* Signed written informed consent.
* Male or female aged 18 - 80.
* Patient agrees to attend all follow-up evaluations and is willing to completely and accurately fill out voiding diaries and questionnaires, and is willing to complete required exams and tests.
* Patients with overactive bladder symptoms:
* Urinary frequency greater than 8 times/24 hours AND/OR Urinary urgency leaks of at least 2 leaks on 3 day voiding diary
* Patient who has failed conservative treatment after at least 6 months of treatment
* Patients with normally functioning upper urinary tract.
* Patients with no clinical evidence of a neurological S2-S4 motor sensory deficit.
* Prior PTNS Group: Patients who have had successful PTNS treatment (successful treatment is defined as ≥50% reduction in urinary frequency, and/or ≥50% fewer incontinence episodes, or a return to normal voiding frequency \[\<8 voids/day\], based on retrospective diary review).
* De novo Patient Group: Patient who passes the BlueWind compatibility test.

Exclusion Criteria:

* Any metal implant in the area of BlueWind Medical implantation site.
* Patients who have not had stable OAB medications for at least 30 days.
* Patients who have received botulinum toxin injections within the past 6 months.
* Previous urinary incontinence surgery or implantation of artificial graft material within the last 6 months.
* Any spinal or genitourinary surgery within the last 6 months. Pelvic pain disorders
* Obvious clinically demonstrated genuine stress incontinence.
* Any neurological disease or disorder including neuropathy or injury resulting in neuropathy.
* Current urinary tract infection, presence of urinary stone and/or urinary tract malignancy (i.e. tumor, vesicourethral reflux, etc.)
* Pelvic radiotherapy and chemotherapy.
* Severe uncontrolled diabetes.
* Patients anticipating magnetic resonance imaging (MRI) exams.
* Presence of cystocele, enterocele or rectocele of grade 3 or 4.
* Prior PTNS Group: Patients who are receiving concomitant nerve stimulation therapies for OAB treatment, except for PTNS maintenance therapy.
* De novo Patient Group: Patients who have received or are receiving nerve stimulation therapies for OAB treatment, including PTNS.
Expression and Role of the JAK/STAT Pathway in Sarcoidosis Granuloma Cells

Recent studies suggest that the JAK/STAT signaling pathway constitutes a new step in the clinical and therapeutic progress of sarcoidosis. Further investigations are necessary to identify the most suitable patients to receive treatment targeting this pathway, in particular in cases of severe sarcoidosis refractory to the various therapeutic lines.

The investigators hypothesize that the JAK/STAT signaling pathway constitutes a new step in the clinical and therapeutic progress of sarcoidosis, in particular in cases of severe sarcoidosis refractory to the various therapeutic lines. The main objective of this proposal is to evaluate the presence and stage of activation of the JAK/STAT pathway in PBMCs from inactive and active sarcoidosis patients. The second objective will be to determine the role of the JAK/STAT pathway in the formation and maintenance of granulomas and their association with the severity of sarcoidosis and fibrogenesis.

Eligibility Criteria:
Inclusion Criteria:

* Patients with a diagnosis of mediastinopulmonary sarcoidosis made according to ATS / ERS / WASOG criteria
* Or patient suspected of having mediastino-pulmonary sarcoidosis, without any other probable causal factor identified on the usual standard examination at the time of the sample with the need for diagnostic confirmation at the end of the study according to the criteria of the ATS / ERS / WASOG
* Sarcoidosis with stage 1 to 4 pulmonary involvement
* Patients who had a chest CT scan in the 6 months preceding the sample. Examination carried out as part of routine care

Exclusion Criteria:

* Pregnancy.
* Opposition expressed to participation in the study.
* Patients on State Medical Aid.
Effectiveness of Electrotherapy Treatment in Chronic Low Back Pain

This study investigates the effectiveness of a specific electrotherapy treatment for individuals with chronic non-specific low back pain. The participants, who had low back pain for more than three months, were divided into two groups: a treatment group and a waitlist control group. The treatment group received electrotherapy using the StimaWELL 120MTRS system, which provided electrical stimulation and heat therapy to the entire spine over four weeks. The study assessed various outcomes, including pain levels, disability, and quality of life, before and after the intervention.


Eligibility Criteria:
Inclusion Criteria:

* 18-65 years old,
* LBP for more than three months,
* Pain of 3 or more according to the Numeric Pain Scale
* being literate

Exclusion Criteria:

* having a pacemaker,
* body mass index greater than 30,
* pathologies of the cervical or lumbar region,
* cervical radiculopathy, thoracic outlet syndrome, malignant conditions,
* systemic diseases, such as neurological, psychological, cardiovascular or rheumatologic conditions, loss of function due to these diseases,
* history of surgery on the spine or upper extremities,
* acute infection
An Open-Label Study To Assess The Pharmacokinetics, Safety And Toleration Of Vfend®; Following Multiple Dosing With Vfend

This is a study to investigate the pharmacokinetics, safety and tolerability of intravenous voriconazole and SBECD in patients with moderate renal insufficiency

The study was put on hold after the first subject was enrolled and experienced a serious adverse event (SAE) of renal failure chronic after receiving his I.V. dose on Day 1. The study was taken off hold after the subject recovered and an independent consultant had deemed the SAE as not treatment related; however, the site was unwilling to enroll additional subjects. Another site, based in New Orleans, was damaged by hurricane Katrina and was unable to enroll any subjects. A decision was made by the sponsor to terminate the study on 11 Apr 2006 due to poor study enrollment. There were no safety or efficacy concerns regarding the study in the decision to terminate the trial.

Eligibility Criteria:
Inclusion Criteria:

* Patients with moderate renal insufficiency

Exclusion Criteria:

* Active infection
Mast Cells Are Involved in the Mechanism of NPSLE Epilepsy

Tryptase, TLR4, and anti-NR2A antibodies were measured in serum, cerebrospinal fluid, and subjects and other markers to assess their relevance to disease activity, aiming to find new therapeutic targets,Timely intervention to improve the prognosis of SLE and improve the quality of life of patients with SLE.

This study is a prospective cohort study: it is proposed to be divided into 3 groups, namely healthy control group and SLE group, NPSLE epilepsy group; Fifteen cases were included in each group, with the consent of the subjects and signed to know Consent form, record all subjects' clinical and laboratory test data, and test subjects' blood. Markers such as cerebrospinal fluid tryptase, TLR4 and anti-NR2A antibodies, follow-up 2 year, the patient's disease activity is evaluated every year, the change of indicators is dynamically observed, and statistical points are made divide.

Eligibility Criteria:
Inclusion Criteria:

1. Healthy control group

   * Voluntary signing of informed consent;
   * Healthy volunteers older than 18 years old and less than 50 years old, regardless of gender;
   * No systemic diseases or neurological symptoms or signs;
   * According to the judge's judgment, healthy volunteers matching the NPSLE epilepsy group in terms of gender, age, and education level were selected as the control group.
2. SLE group

   * Voluntary signing of informed consent;
   * Age greater than 18 years old, less than 50 years old, gender is not limited;
   * Patients with SLE who meet diagnostic criteria.
3. NPSLE Epilepsy Group

   * Voluntary signing of informed consent;
   * Age greater than 18 years old, less than 50 years old, gender is not limited;
   * Patients with NPSLE epilepsy who meet diagnostic criteria.

Exclusion Criteria:

1. SLE group

   * patients with SLE with other autoimmune diseases;
   * Previous seizures, psychiatric abnormalities and other manifestations;
   * MR of the head has obvious abnormal signals in the skull or EEG shows abnormal signals;
   * History of use of hormones and immunosuppressants;
   * The investigators judged that it was not suitable to participate in this study.
2. NPSLE Epilepsy Group

   * prior history of epilepsy or clear cranial MR findings suggesting structural abnormalities;
   * Presence of precipitating seizures such as sleep deprivation, high fever, infection, long-term abstinence from alcoholism
   * Interrupt, patients with systemic diseases such as hypoglycemia, severe electrolyte disorders, malignant lesions, progressive or degenerative diseases, severe liver and kidney insufficiency and other metabolic diseases;
   * The investigators judged that it was not suitable to participate in this study.
Preoperative Decolonization and Surgical Site Infections - a Prospective Randomized Trial

Surgical site infections are a major postoperative complication and are mostly due to colonization with endogenous germs, like Staphylococcus aureus, Staphylococcus epidermidis or Propionibacterium acnes. In literature, preoperative decolonization procedures showed a trend in lowering surgical site infection rates, but especially in orthopedic surgery data is controversial and randomized controlled trials are lacking. In the main study, the study investigators aim at performing a controlled prospective randomized interventional trial to measure the impact of preoperative decolonization of nasal Staphylococcus aureus carriers on surgical site infection rates in orthopedic surgery. In an alongside study a controlled prospective randomized interventional trial to measure the impact of preoperative skin decolonization of patients undergoing an orthopedic procedure will be conducted.

All participants will be assessed for eligibility during preoperative othopedic consultation. 2-3 weeks prior operation date participants will be screened for Staph. aureus carriage by nose-swab. According to nose-swab results randomizaton and allocation to study arm will be performed.

After one and three months post-operatively participants will be asked by phone interview if surgical site infections occured. Results have to be confirmed by orthopedic surgeon if possible.

Eligibility Criteria:
Inclusion Criteria:

* patient older than 16 years
* patient undergoing elective orthopedic procedure at the Sonnenhof hospital
* decolozination protocol can be performed timely
* signed informed consent

Exclusion Criteria:

* no orthopedic surgery planned
* allergy to mupirocin or chlorhexidine
* presence of a nasal foreign body
* no informed consent
* pregnancy
* decolozination protocol can't be followed timely
* patients undergoing treatment/surgery for a documented infection
Neck Dissection vs Radiotherapy for Cervical Metastases in Advanced Hypopharyngeal Cancer

At the time of diagnosis, approximately 60%-80% of patients with hypopharyngeal cancer are found with cervical lymph node metastasis. Cervical nodal metastasis is an important prognostic factor in hypopharyngeal cancer. Induction chemotherapy is frequently used in advanced hypopharynx cancer. However, sometimes CR was obtained at the tumor's primary site but not in the palpable lymph nodes in the neck, the large cervical lymph node metastasis poorly responded to induction chemotherapy in a considerable percentage of patients. At present, patients with primary tumor achieved CR preferred to receive definitive radiotherapy no matter cervical lymph node metastasis SD or progression. But, radiotherapy was poor effective to the big cervical lymph node metastasis, because the inner of big cervical lymph node metastasis was hypoxic and necrosis. The investigators conducted a prospective, randomised trial to compare neck dissection with definitive radiotherapy for advanced hypopharyngeal cancer cervical lymph node metastasis with poor response to induction chemotherapy.


Eligibility Criteria:
Inclusion Criteria:

1. Ability to understand and the willingness to sign a written informed consent document
2. Age≥ 18 and≤ 75 years
3. Histological/ cytological/ Imaging examination proven hypopharyngeal squamous-cell carcinoma in preoperative assessment
4. Advanced hypopharyngeal cancer with metastatic cervical lymph node more than 2cm in diameter
5. EPOG≤1,KPS≥ 70
6. No contraindication of surgery and radiotherapy
7. No serious disease history of the heart, liver, kidney, lung and other important organs
8. Expected survival period≥ 12 months
9. Good compliance

Exclusion Criteria:

1. Inability to provide an informed consent
2. Other malignancy tumor history,(except for cured skin basal cell carcinoma and papillary thyroid carcinoma)
3. Serious cardiovascular, liver, respiratory, kidney and neurologic and psychiatric disease with clinical symptoms
4. The patient has received prior surgery or radiotherapy (except for biopsy)
5. The patient has received chemotherapy or immunotherapy
6. Pregnant or lactating women
7. Other disease requiring simultaneous surgery or radiotherapy
Effect of Exercise on Endothelial Function and Vascular Compliance in Chronic Kidney Disease

The study hypothesis is that 6 weeks of repetitive handgrip exercise will improve endothelial function and venous compliance in pre-dialysis patients with an estimated glomerular filtration rate of less than or equal to 20 ml/min. If proven correct then arm exercise might be useful to improve the success rate for a surgically created arteriovenous fistula in the forearm to become usable as a vascular access for hemodialysis.

An arteriovenous fistula (AVF) is the optimal vascular access for chronic hemodialysis. However, AVFs frequently fail to mature. Better strategies are needed to promote AVF maturation. Successful AVF maturation involves arterial and venous dilation. Arterial dilation depends on endothelial release of nitric oxide which can be measured by brachial artery flow-mediated dilation (FMD) and has been reported to predict successful AVF maturation. Venous dilation depends on venous compliance which can be measured by venous plethysmography and is also predictive of successful AVF maturation. Endothelial function is impaired in patients with chronic kidney disease (CKD). Aerobic exercise has been reported to improve endothelial function and venous compliance but it has not been studied in the pre-dialysis patient. To address this question we will determine whether 6 weeks of repetitive handgrip exercise with upper arm venous compression can improve brachial artery endothelial function or venous compliance in pre-dialysis patients with an estimated glomerular filtration rate of less than or equal to 20 ml/min.

Eligibility Criteria:
Inclusion Criteria:

* Age exceeding the age of majority (18 years of age).
* Chronic renal failure with a calculated GFR (MDRD equation) less than or equal to 20 ml/min
* Eligible for creation of an arteriovenous fistula for the purpose of hemodialysis.
* The subject is expected to stay within driving distance of study site for at least 4 months.
* The subject's physician(s) will allow the patient to participate.
* Ability to give informed consent.

Exclusion Criteria:

* Unstable angina.
* Uncontrolled hypertension (resting blood pressure \>170 systolic or \>100 diastolic).
* Musculoskeletal or neurologic problem that prevents arm exercise.
* Currently functioning arteriovenous access in the same arm as the planned new fistula.
* Subjects who are eligible to participate in the ongoing DAC fistula trial.
* Planned new access surgery in less than 6 weeks
* Anticipated non-compliance with medical care based on physician judgment.
* Patient refusal.
The Study of Apatinib Plus CIK as the Third Line Therapy for Advanced Lung Adenocarcinoma Patients With Wild-Type EGFR

The purpose of this study is to evaluate the safety and efficacy of Apatinib combined with cytokine-induced killer cell (CIK) vs Apatinib alone as the third line therapy for advanced lung adenocarcinoma patients with wild-type EGFR

400 patients with stage IIIB \& IV lung adenocarcinoma who had received surgery and chemotherapy,will be randomly divided into group A（Apatinib plus CIK treatment ) or group B（Apatinib), and the randomize ratio will be 1:1. Patients in group A will receive 3 cycles of CIK treatment (every 1 year) and Apatinib (continuous).Patients in group B will receive only Apatinib (continuous) .

Eligibility Criteria:
Inclusion Criteria:

* Histologically or cytologically confirmed Lung adenocarcinoma
* Wld-type EGFR
* Stage IIIB/IV
* Failure to prior chemotherapy
* Life expectancy of more than 3 months
* Tissue sample desired for genomic study
* Age ≥ 18 years
* Performance status (WHO) \< 3
* Adequate bone marrow function (absolute neutrophil count\>1000/mm\^3, platelet count \> 100000/mm\^3, hemoglobin \> 9gr/mm\^3)
* Adequate liver (bilirubin \< 1.5 times upper limit of normal and SGOT/SGPT \< 2 times upper limit of normal) and renal function (creatinine \< 2mg/dl)
* Presence of two-dimensional measurable disease. The measurable disease should not have been irradiated
* Informed consent

Exclusion Criteria:

* Lung squamous cell carcinoma or other types of Non-Small cell lung cancer
* Small cell lung cancer
* Have previously received TKIs
* Hemoglobin\<8.0 g/dL,White blood cell \<3 X 10\^9/L;Platelet count \<75 X 10\^9/L; alanine aminotransferase, glutamic-oxalacetic transaminase, blood urine nitrogen and creatinine more than normal limits on 3.0 times
* Known or suspected allergy to the investigational agent or any agent given in association with this trial
* Pregnant or lactating patients
* Known history of Human Immunodeficiency Virus (HIV), Hepatitis C Virus (HCV) or TreponemaPallidun (TP) infection
* Patients who are suffering from serious autoimmune disease
* Patients who had used long time or are using immunosuppressant
* Patients who had active infection
* Patients who are suffering from serious organ dysfunction
* Patients who are suffering from other cancer
* Other situations that the researchers considered unsuitable for this study.
* Other concurrent uncontrolled illness
Effect of Selective COX-2 Inhibition on Ulcer Healing

The purpose of this study is to compare the effect of Famotidine plus a COX-2 inhibitor (celecoxib) with Famotidine plus dologesics in ulcer healing in arthritis patients.

For many years the integrity of the stomach mucosal barrier is thought to be maintained by mucosal prostaglandins (PG) synthesized by COX-1. However, the notion that COX-1 protects the stomach and COX-2 induces inflammation may be over-simplistic. In animal studies, COX-2, but not COX-1, is expressed in experimental gastric ulcer. Inhibition of COX-2 delays ulcer healing, indicating that PG derived from COX-2 contributes to restoring the mucosal barrier \[1\]. Whether this animal observation can be generalized to the human stomach is unknown. To date the biological functions of COX-1 and COX-2 in the healing of human gastric ulcer healing is unclear. Unlike experimental ulcers that only express COX-2, recently we have shown that both COX-1 and COX-2 are up-regulated in human gastric ulcers \[2\]. Furthermore, our preliminary results suggest that inhibition of COX-2 alone may not lead to a clinically significant delay in ulcer healing (refer to progress report). These observations suggest that peptic ulcer healing is more complex in the human stomach - both COX isoforms may be involved in the healing process. Inhibition of COX-2 alone may have less adverse effect than non-selective inhibition of both COX isoforms in ulcer healing. The current study aims to resolve the functional significance of COX-2 in human gastric ulcer from a biological and clinical perspective.

Eligibility Criteria:
Inclusion Criteria:

* Gastric ulcers confirmed by endoscopy
* Stop taking NSAIDs for 1 week prior to endoscopy
* Age 18
* H. pylori negative
* Informed written consent

Exclusion Criteria:

* Actively bleeding ulcers
* Ulcers showing dysplasia or malignancy
* Renal failure (serum creatinine \>200umol/l)
* Previous gastric surgery
* Moribund or terminal malignancy
* Concomitant use of proton pump inhibitor, misoprostol, aspirin, steroid or anticoagulant