cyrilzakka/clinical-trials huggingface dataset:
A Study of Apatinib Plus EGFR-TKI as First Line Treatment in Patients With Non-squamous NSCLC Harboring EGFR Mutations

The purpose of this study is to evaluate the efficacy and safety of apatinib plus EGFR-TKI as first line treatment in patients with non-squamous NSCLC harboring EGFR mutation.


Eligibility Criteria:
Inclusion Criteria:

1. Age:18 to 75 years old (man or female);
2. Pathologically diagnosed with non-squamous NSCLC;
3. Imageology diagnosed with locally advanced/metastatic or recurrent (stage ⅢB - IV);
4. Histologically or cytologic confirmed，harboring an activating EGFR mutation (19del or 21 L858R);
5. None previous chemotherapy or targeted therapy.（NOTE: neoadjuvant and adjuvant therapy is allowed）;
6. At least one measurable lesion (measuring≥10mm on spiral CT scan, satisfying the criteria in RECIST1.1)；
7. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2;
8. Major organ function has to meet the following criteria:

   1. HB≥90g/L；
   2. ANC≥1.5×109/L；
   3. PLT≥80×109/L；
   4. ALT and AST≤2.5ULN, but≤5ULN if the transferanse elevation is due to liver metastases;
   5. TBIL≤1.5ULN;
   6. Serum creatinine≤1.25ULN; Endogenous creatinine clearance rate\>45 ml/min;
9. Life expectancy greater than or equal to 3 months;
10. Women of childbearing age must have contraceptive measures or have test pregnancy (serum or urine) enroll the study before 7 days, and the results must be negative, and take the methods of contraception during the test and the last to have drugs after 8 weeks. Men must be contraception or has sterilization surgery during the test and the last to have drugs after 8 weeks;
11. Participants were willing to join in this study, and written informed consent, good adherence, cooperate with the follow-up.

Exclusion Criteria:

1. Have high blood pressure and antihypertensive drug treatment can not control (systolic blood pressure \> 140 mmHg, diastolic blood pressure \> 90 mmHg);
2. Patients who suffered from grade II or above myocardial ischemia or myocardial infarction, uncontrolled arrhythmias (including QT interval male ≥ 450 ms, female ≥ 470 ms). Grade III-IV cardiac insufficiency according to New York Heart Association(NYHA) criteria or echocardiography check: left ventricular ejection fraction (LVEF)\<50%;
3. Radiologically documented evidence of major blood vessel invasion or encasement by cancer;
4. A variety of factors influencing oral drugs (such as unable to swallow, nausea, vomiting, chronic diarrhea and intestinal obstruction, etc);
5. Patients with tendency of gastrointestinal bleeding, including the following: a local active ulcerative lesions, and defecate occult blood (++). Has melena and hematemesis in two months;
6. Coagulant function abnormality (INR \> 1.5 ULN, APTT \> 1.5 ULN), with bleeding tendency;
7. Patients with pregnant or planning a pregnancy;
8. Patients with other malignant tumors within 5 years (except for the treated skin basal cell carcinoma and cervical carcinoma in situ);
9. History of psychiatric drugs abuse and can't quit or patients with mental disorders;
10. Less than 4 weeks from the last clinical trial;
11. The researchers think inappropriate.
"Platelet Rich Plasma for the Management of Post-Viral Olfactory Dysfunction.

SARS COV-19 has resulted in prolonged olfactory dysfunction in many patients. The investigators aim to compare the effect of topical platelet-rich plasma (test) vs saline (placebo) in patients with covid-related post-viral olfactory dysfunction.

The investigators hypothesize that the use of topical PRP will improve smell identification, threshold, and smell-related quality of life in comparison to a placebo.

This study will provide critical information for a promising new treatment of olfactory dysfunction with the highest level of evidence, in a randomized, placebo-controlled trial. Preliminary results from an ongoing pilot study investigating topical PRP is the basis for the hypothesis.

By investigating the efficacy of topical PRP in smell restoration, the investigators will provide a less-invasive way to deliver this autologous product. A randomized trial will set a precedent for the use of this treatment to serve a growing population of patients affected with post-COVID olfactory dysfunction. Over a period of one year, participants with post-viral olfactory dysfunction will be randomly assigned to a test or control group and will visit the clinic monthly for three months to receive PRP or saline based on their randomized group. This will be followed by 9 months of at-home electronic visits. At each visit both the test and control groups will undergo smell testing and will fill quality of life questionnaire.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients suffering from either post-viral or post-COVID smell loss of any duration, without a history of nasal surgery, nasal polyposis, chronic rhinosinusitis, or intranasal tumors
* Patients who are post-COVID must report at least a positive home test on history
* Patients with post-viral etiology must have recall of a viral illness that immediately preceded smell loss

Exclusion Criteria:

* History of olfactory dysfunction predating COVID-19 infection
* History of trauma, previous surgery, or obstructive cause of OD (nasal polyps, chronic rhinosinusitis)
* Pregnancy
* Patients who are unable to provide consent
* Patients with known bleeding disorders
* Patients with known malignancies
Hybrid Approach to Mirror Therapy and Transcranial Direct Current Stimulation for Stroke Recovery

We hypothesize that (1) the hybrid therapy will induce greater improvements on some health-related outcomes compared to other therapies; (2) such benefits will retain at 6-month follow-up; (3) better motor control and brain reorganization will be found in the hybrid therapy than the other therapies; (4) correlations will be found between brain activity and movement kinematics/health-related outcomes.

Chronic stroke participants will be recruited from the Chang Gung Memorial Hospital and then were randomly assigned to 1 of the 4 groups: MT+tDCS, MT+sham tDCS, MT, and CI groups. The participants in each group receive equivalent amounts of treatment.

Analysis of covariance (ANCOVA), controlling for the pretest differences, will be separately performed for each outcome measure to test the effects of different intervention groups.

Eligibility Criteria:
Inclusion Criteria:

* First episode of stroke in cortical regions
* Time since stroke more than 6 months
* Initial motor part of UE of FMA score ranging from 24 to 52, indicating moderate to mild movement impairment
* No severe spasticity in any joints of the affected arm (Modified Ashworth Scale ≤ 2)
* No serious cognitive impairment (i.e., Mini Mental State Exam score≧ 24)
* Willing to sign the informed consent form.

Exclusion Criteria:

* Aphasia that might interfere with understanding instructions
* Visual/attention impairments that might interfere with the seeing of mirror illusion, including hemineglect/hemianopsia
* Major health problems or poor physical conditions that might limit participation
* Currently participation in any other research
* Previous brain neurosurgery
* Metallic implants within the brain.
Abdominal Aortic Aneurysm Stabilization With Truncal Cells: Controlled Clinical Trial With Historical Cohorts

Phase IIa, single-center clinical trial compared with historical cohorts to evaluate the preliminary safety and efficacy of an allogeneic adipose tissue-derived mesenchymal stem cells infusion in an aneurysmal sac for the treatment of AAA.


Eligibility Criteria:
Inclusion Criteria:

1. Subjects with AAA greater than 5 cm diameter with endovascular treatment indication, analyzed by aortic AngioCT.
2. Subjects ≥ 18 years at the time of inclusion.
3. Subjects with a good infrarenal neck for a standard device placement, neither fenestrated nor branched.
4. Patients with an estimated life expectancy greater than 2 years at the time of inclusion.
5. Women with childbearing capacity must have a negative pregnancy test at the time of inclusion and must agree to use highly effective contraceptive methods (diaphragms plus spermicide or male condom plus spermicide, oral contraceptive combined with a second method contraceptive implant, injectable contraceptive, permanent intrauterine device, sexual abstinence or partner with vasectomy) during their study participation.
6. The patient must be able to attend all study visits and comply with all study procedures.

Exclusion Criteria:

1. Patients with unresolved neoplasia history or hematologic disease.
2. Patients with uncontrolled arterial hypertension (≥180/110) at the time of inclusion.
3. Patients with severe heart failure (New York Heart Association \[NYHA\] IV) or ejection fraction \<20%.
4. Patients with malignant ventricular arrhythmias
5. Patients with deep vein thrombosis the last three months
6. Patient with active sepsis at the time of inclusion
7. Patients with acute myocardial infarction or stroke in the previous month
8. Any type of medical or psychiatric illness that, in investigator opinion, could be a reason for exclusion from the study.
9. Patient with major surgery or severe craniocerebral trauma in the 3 months prior to inclusion in the study.
10. Administration of any investigational drug at the time of inclusion or in the 3 months prior
11. Infants or pregnant women
12. Transplanted patients.
Design of the EFECTS Trial

It is well known that there is a considerable postoperative weight loss in patients undergoing esophageal resection for cancer.

We believe that this weigh loss can be limited by administering postoperative enteral feeding (target: 1000 kCal/ day) via feeding jejunostomy for at least 6 weeks postoperatively.

We hypothesize that patients undergoing esophageal resection for cancer will have a better overall survival with postoperative additional enteral feeding than when on regular oral diet alone.


Eligibility Criteria:
Inclusion Criteria:

* advanced cT2 N+ or cT3 Nx
* all histology
* GEJ or distal esophageal ACC
* proximal or mid SCC
* curative intent with intention to treat
* no M+
* at least two-field lymphadenectomy
* all access: MIE, left thoraco freno or R thoraco + laparotomy with intrathoracic or cervical anastomosis
* all anastomosis (intrathoracic, cervical)

Exclusion Criteria:

* T4
* R2
* transhiatal
* pt in definitive CRT or rescue resection following definitive CRT
* palliative treatment
* tumours in cervical esophagus
* pharyngeal cancer with gastric pull-up
A Study of Ritonavir-Boosted Invirase (Saquinavir) in Treatment-Naïve HIV-1 Infected Patients

This open-label study will evaluate the safety, pharmacokinetics and antiviral activity of a modified Invirase (saquinavir)/ritonavir regimen in treatment-naïve HIV-1 infected patients. Patients will receive Invirase 500 mg plus ritonavir 100 mg twice daily orally for the first week, followed by Invirase 1000 mg plus ritonavir 100 mg twice daily orally for the second week. The study treatment will be given in combination with two Nucleoside Reverse Transcriptase Inhibitors (NRTIs), in accordance with the current clinical HIV treatment guidelines. Anticipated time on study treatment is 14 days.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients, \>/= 18 years of age
* HIV-1 infection
* Currently treatment-naïve and eligible to initiate a ritonavir-boosted Protease Inhibitor based regimen and willing and able to initiate saquinavir/ritonavir therapy for the first 14 days; the saquinavir/ritonavir regimen will be in combination with two Nucleoside Reverse Transcriptase Inhibitors (NRTIs), in accordance with the current clinical HIV treatment guidelines
* Body mass index 18-32 kg/m2, inclusive
* Female patients of childbearing potential and male patients with female partners of childbearing potential must use 2 methods of contraception as defined by protocol during the study and for at least one month after the last dose of study drug
* Non-smoker or patients who have stopped smoking more than three months prior to Day 1 of the study

Exclusion Criteria:

* Coinfection with hepatitis B or C (acute or chronic)
* Anticipated use or need for significant concomitant medical treatment during the study period, other than background antiretroviral therapy
* Participation in a clinical study with an investigational drug or device within 3 months prior to Day 1 of the study
* Pregnant or lactating women
* Any clinically relevant history of substance abuse or addiction including alcohol and/or other drugs of abuse
* Special dietary restrictions that would prohibit consumption of standardized meal (e.g. vegetarian, vegan, gluten-free, lactose-free, kosher)
* Decompensated liver disease
* Congenital or documented acquired QT prolongation
* Electrolyte disturbances, particularly uncorrected hypokalaemia
* Clinically relevant bradycardia
* Clinically relevant heart failure with reduced left-ventricular ejection fraction
* Previous history of symptomatic arrhythmias
* History of clinically significant gastro-intestinal, renal, hepatic, bronchopulmonary, neurological, psychiatric, cardiovascular, endocrinological, , hematological, or allergic disease, metabolic disorder, cancer, or cirrhosis
Self-injection of Adalimumab in Adult Japanese Subjects With Rheumatoid Arthritis

The purpose of this study is to evaluate the long-term safety of subcutaneous (SC) self-injections (by the subject or subject's family member) of adalimumab in adult Japanese subjects with Rheumatoid Arthritis in an open-label study.


Eligibility Criteria:
Inclusion Criteria:

* Completed Week 36 of Study M03-651 \[NCT 00235872\]
* Wish to participate in self-injection study
* Give written informed consent
* Comply with protocol requirements

Exclusion Criteria:

* Subject develops serious adverse events at time of eligibility confirmation
* Subject develops severe infections requiring hospitalization or IV injection of antibiotics within 28 days before eligibility confirmation
* Subject develops infections requiring oral administration of antibiotics within 14 days before eligibility confirmation
* The investigator considers the subject inappropriate for participation
Use of Diuretics in Maintenance Hemodialysis Patients Undergoing Bioimpedance-guided Fluid Management

Background.The objective of the present study is to verify whether using diuretics will improve either blood pressure or fluid overload in maintenance hemodialysis patients with residual diuresis kidney function.

Methods.46 maintenance hemodialysis patients will be given three stages of diuretic intervention: 100mg furosemide every day for 1 month, 200mg furosemide every day for 1 month, and 100mg furosemide combined with 25mg hydrochlorothiazide every day for 1 month. The 24-hour urine volume, 24-hour urine sodium, 24-hour urine potassium, blood pressure, OH(overhydration) and dry weight will be collected. OH will be measured by bioelectrical impedance.

Eligibility Criteria:
Inclusion Criteria:

* maintenance hemodialysis patient
* unrine volume more than 100ml.

Exclusion Criteria:

* myocardial infarction;
* unrine volume less than 100ml.
Study to Evaluate Efficacy and Safety of PreLipid® on Subjects With Higher Than Normal Blood Lipid Levels

Study to evaluate Efficacy and Safety of PreLipid® on subjects with higher than normal blood lipid levels

A Prospective, Double Blind, Placebo-Controlled, Randomized, Multicentric, study to evaluate the safety, efficacy and tolerability of PreLipid®, a twice-daily nutritional supplement in subjects with higher than normal blood lipid levels

Eligibility Criteria:
Inclusion Criteria:

Newly diagnosed Male or Female participants with higher than normal cholesterol levels defined by the American Heart Association, National Cholesterol Education Program (NCEP) and ATP-III goals for LDL cholesterol and cut off points for therapeutic lifestyle changes (TLCs) and drug therapy in different risk categories:

1. Age ≥ 18 years to ≤ 65 years
2. LDL cholesterol levels \>120mg/dl
3. Ability to understand and willingness to sign and date a written Informed Consent Document at the screening visit before any protocol- specific procedures are performed and willing to adhere to the protocol and entire trial procedures -

Exclusion Criteria:

1. Stroke, myocardial infarction, coronary artery bypass graft (CABG) percutaneous transluminal coronary angioplasty (PTCA) or angina pectoris in the past.
2. Cardiac status New York Heart Association class III-IV
3. Uncotrolled blood pressure \> 150 mmhg systolic and \> 100 mmhg diastolic
4. Impaired renal function as shown by but not limited to serum creatinine ≥ 1.5 mg/dl for males and ≥ 1.4 mg/dl for female
5. Clinically significant peripheral edema
6. Clinical evidence of active liver disease or serum alenine aminotransferase (ALT) or aspartate amino transferase (AST) 2.5 times the upper limit of the normal range (2.5 X ULN)
7. Participants on steroid
8. Pregnancy or lactating women
9. Known hypersensitivity to any of the study drugs
10. Any malignancy within the last 5 years, with exception of adequately treated basal or squamous cell carcinoma of the skin or adequately treated carcinoma insitu.
11. Current addiction or current alcohol abuse or history of substance or alcohol abuse within the last 2 years
12. Subject is the investigator or any sub-investigator, research assistant, pharmacist, study coordinator, other staff or relative thereof directly involved in the conduct of the protocol
13. Mental condition rendering the subject unable to understand the nature, scope and possible consequences of the study.
14. Subject unlikely to comply with protocol e.g. uncooperative attitude, inability to return for follow up visits and unlikelihood completing of the study
15. Any disease or condition that in the opinion of the investigator and/or sponsor may interfere with the completion of the studyevaluation.

    -
Varus Stem Positioning of a Cementless Anatomical THA. (VARABG)

Varus positioning is the most common femoral malposition in total hip arthroplasty (THA). The aim of this study was to compare the long-term results of an anatomical cementless femoral stem positioned in varus with those in neutral alignment.

Data were prospectively collected and retrospectively reviewed for all patients who received a cementless anatomical femoral stem in THA between 1998 and 2008. After exclusion criteria applied, 127 stems had an varus axis deviated by more than 3 degrees (varus group) and 156 had an alignment between 0 and 2.9° from the femoral axis (neutral group). Survivorship rates, complications, clinical scores, thigh pain, radiological score, cortical hypertrophy and filling rate were analyzed. Mean follow-up was 10 years.

Eligibility Criteria:
Inclusion Criteria:

* All patients received by several senior surgeons, the same standardized posterolateral total hip arthroplasty, and the same rehabilitation protocol.

Exclusion Criteria:

* Etiologies other than osteoarthritis (osteonecrosis, fracture, dysplasia, rheumatoïd arthritis),
* Complex cases with additional procedure,
* Dual-taper modular or cemented stem,
* Incomplete preoperative data or less than one-year postoperative data.
The Microbiological Assessment of Deep Carious Lesions After Step-wise Excavation and Diode Laser Cavity Disinfection .

This study will be conducted to assess antibacterial effect of the diode laser in deep carious cavity after step wise excavation using the bacteriological assessment method.

each patient should have at least two deep carious lesions The first clinical step in all teeth will be the opening of the cavity and the removal of undermined enamel . Caries at the lateral walls of the cavity and at the enamel-dentin junction was completely removed with excavators and/or round carbide burs at low speed. Subsequently, the central cariogenic biomasses and superficial part of the necrotic and demineralized dentin were removed. then excavation continued until the pulp exposure would occur with further excavation; thus, a layer of soft carious dentin was left on the cavity floor adjacent to the pulp wall.

A dentine samples will be then collected from the base of the cavity using sterile spoon excavator from the both groups for baseline bacteriological assessment and another sample will be taken after disinfection with diode laser in the intervention group .

In the two groups The remaining innermost layer of carious dentin are covered with calcium hydroxide The cavity was then sealed with restorative material (resin modified glass ionomer) after a 6 month period. This time was considered adequate for calcium hydroxide to exert its effect and for the pulp to respond with possible formation of tertiary dentin. The teeth were followed up every month and the integrity of the temporary restoration checked. After this interval of 6 months. After the rubber dam application, the temporary filling is removed samples are collected and the teeth are finally restored

Eligibility Criteria:
Inclusion Criteria:

1. Patients with at least two deep occlusal carious lesion .
2. 18 - 25years.
3. Males or Females.
4. Good oral hygiene.
5. Co-operative patients approving the trial and willing to sign a written consent.

Exclusion Criteria:

1. Pregnancy.
2. Systemic disease or severe medical complications.
3. Heavy smoking.
4. Xerostomia.
5. Lack of compliance.
6. Evidence of temporomandibular joint disorders.
Assessing the Role of Pharmaceutical Technical Assistents in Hospital Wards: Measuring Efficiency and Medication Safety

The goal of this interventional study is to evaluate the impact of implementing pharmaceutical technical assistants (PTAs) to support the medication process on hospital wards on operational efficiency and medication safety among nurses and pharmaceutical technicial assistants. The main questions it aims to answer are:

* What is the effect of PTAs on the time spent by (night) nurses on medication dispensation?
* How does their involvement influence unplanned interactions between nursing staff and the pharmacy?
* What is the impact of PTAs on the safety of medication processes, including missed or delayed doses, accuracy of dispensed medication, and reported medication errors?

Researchers will compare periods with and without the involvement of PTAs in the medication management process on the hospital ward to assess differences in:

* Time spent on medication dispensation.
* Frequency of unplanned interactions between hospital wards and the pharmacy.
* Rates of missed or delayed medication doses.
* Accuracy of dispensed medication compared to prescriptions.
* Reported medication errors.

During the observed medication dispensation processes, involved nurses and PTAs will:

* Be observed while preparing medications to measure time and interruptions.
* Provide data on medication errors and delays through digital systems and reports.
* Complete a demographic questionnaire about their professional background. This study involves both intervention and control periods, allowing researchers to measure the specific effects of PTAs' involvement in medication processes.


Eligibility Criteria:
Inclusion Criteria for observed medication dispensation moments

Control Period:

* Medication dispensation moments must be performed by nurses during the nightshift. .
* Nurses included must have at least six months of experience working night shifts.

Intervention Period:

* Medication dispensation moments must be performed by PTAs.
* PTAs included must have at least six months of experience specifically in medication dispensation tasks.

Exclusion Criteria: Hospital wards that introduced the involvement of PTAs less than six months ago.