cyrilzakka/clinical-trials huggingface dataset:
Expression of CXCR4 in Patients With Systemic Lupus Erythematosus

The objective of this study is to estimate the possible role of CD184 in the pathogenesis of SLE; comparing its level among SLE cases to healthy controls.

Detection of CXCR4 (CD184) expression on CD19+ B cells by flow cytometry in patients of SLE, comparing its level in the development of lupus activity and pathogenic process of SLE internal organ involvement/ mucocutaneus and/or musculoskeletal involvement. Identify this correlation will be useful for clarifying other accessory factors to improve the diagnosis, better treatment strategy, follow up as well as prognosis for these patients

Eligibility Criteria:
Inclusion Criteria:

* Confirmed SLE patients diagnosed and fulfilled the SLE classification criteria according to the 2019 ACR/EULAR classification criteria for SLE (Aringer et al., 2019)
* Willing and agreed to be included in the study.

Exclusion Criteria:

* Childhood SLE.
* SLE-patients will refuse to consent to this study.
* Other autoimmune diseases.
* Known or suspected malignancies, especially B cell lymphoma.
Addressing Sexual Concerns in Breast Cancer: Patient Intervention Study

The goal of this study is to evaluate an educational video intervention (called Starting the Conversation) aimed to enhance breast cancer patients' beliefs about and communication with respect to sexual concerns. In the current study, 128 breast cancer outpatients will be randomized to either participate in the video intervention and to receive a resource guide addressing sexual and menopausal health or to receive the resource guide alone. Patients will be asked to participate in the video and/or read through the resource guide prior to their clinic visit with their breast cancer provider. The investigators will examine effects of the interventions on patients' beliefs about communication about sexual health and on patients' communication about sexual health during clinic visits with their providers. Secondarily, the investigators will examine effects of the interventions on sexual outcomes and other health outcomes, including psychological well-being and health-related QOL.


Eligibility Criteria:
Inclusion Criteria:

1. Receiving any treatment for breast cancer or have completed acute treatment for breast cancer \< 10 years ago
2. Attending clinic visits in the course of follow-up care (i.e., not an initial consult visit)
3. Willing to have clinic visit audio recorded

Exclusion Criteria:

1. Unable to speak English
2. Eastern Cooperative Oncology Group (ECOG) Performance score \> 2 OR too ill to participate as judged by physician, self-report, or observation of the research team member
3. Overt cognitive dysfunction or psychiatric disturbance or severe mental illness (e.g., dementia, suicidal behavior, or psychosis), as observed or judged by the researcher or referring source.
Comparison of N&H Sandwich Technique and Cesarean Hysterectomy in Management of Placenta Accreta Spectrum

The placenta accreta spectrum (PAS)is one of the most common reasons for cesarean hysterectomy Which associated with high rates of severe maternal morbidity (40%-50%), with reported mortality rates up to 7%. And, a cesarean hysterectomy might not be considered first-line treatment for women who have a strong desire for future fertility.

Conservative management of PAS defines all procedures that aim to avoid peripartum hysterectomy and its related morbidity and consequences.

The main types of conservative management which have been described in the literature: the extirpative technique (manual removal of the placenta); leaving the placenta in situ or the expectant approach; one-step conservative surgery and the Triple-P procedure. These methods have been used alone or in combination and in many cases with additional procedures such as those proposed by interventional radiology.

patients were allocated to one of two groups. Group (I): patients will be received N\&H technique Group (II): patients will be received cesarean hysterectomy. In the N\&H group, after acceptable control of bleeding from the placental bed, the internal os of the cervix was identified a double uterine compression suture at the lower uterine segment with inflated Foley's catheter balloon tamponade was performed as follow: (i) 100-cm Vicryl no. 1 was thrown to form two nearly equal parts (each 50 cm) on a blunt semicircular 70-mm needle, the curve of the needle was straightened.

(ii) The needle transfixed the right side of the uterine wall from anterior to posterior, about5 cm below the hysterotomy incises posterior, then the needle transfixed the left side of the uterine wall from posterior to anterior, about 2 cm below the hysterotomy incision.

(iii) another transverse compression suture undertook above the first one by 3 cm and below the hysterotomy incision by 2 cm.

(iv) At the end of the suture application and before tying the knots, the internal os of the cervix was identified and a double-way 20 Fr Foley's catheter with a 30-50-ml balloon (Medical Industries, 10th of Ramadan City, Egypt) was inserted through the cervix to be handled by an assistant through the vagina and fixed to the patient's lower limb after inflation of the catheter balloon by 80 ml warm saline and pulling it against the lower uterine segment between the two transverse sutures . Only one catheter was used for tamponade.

(v) Lastly ties the sutures.

Eligibility Criteria:
Inclusion Criteria:

* all pregnant women with a full-term pregnancy with placenta accreta spectrum

Exclusion Criteria:

* Patients with a cardiac, hepatic, renal or thromboembolic disease.
* patients with pelvic endometriosis and adnexal mass.
* those presented with severe antepartum hemorrhage will be excluded
* known coagulopathy
* twin pregnancy
A Controlled Study of Uric Acid on the Progression of IgA Nephropathy

This prospective, randomized controlled study will evaluate the effect of uric acid on the progression of IgA nephropathy.

It has been reported that hyperuricemia is a risk factor for progression of IgAN. This will be a prospective, randomized study. Eligible IgAN patients will be randomized into the treatment group and the control group. Patients in treatment group will receive allopurinol and usual therapy. Patients in control group will receive usual therapy with placebo. If with hypertension, add the CCB and the β-blocker. Fasting uric acid, serum creatinine, albumin, routine blood test, urine microscopy and dipstick, proteinuria of 24 hours and blood pressure will be measured every month. After followed-up for 6 months, the curative effect of Allopurinol on blood pressure, proteinuria and the progression of IgA nephropathy will be evaluated.

Eligibility Criteria:
Inclusion Criteria:

1. Subjects of either sex, more than 18 years old, the range of age is 18 to 70 year old.
2. Biopsy-proven IgA nephropathy.
3. Proteinuria between 0.15g/d and 3.0g/d; and serum albumin level\>3.5g/dl.
4. Serum creatinine \< 3 mg/dl.
5. Uric acid \> 6 mg//dl (360umol/dl) in female; Uric acid \>7mg/dl (420umol/dl ) in male.
6. No history of taking ACEI or ARB within 2 weeks.
7. Blood pressure \< 180/110 mmHg.
8. Subjects who agree to participate in the study and sign the informed consent.

Exclusion Criteria:

1. Patients who have received prednisone or immunosuppressive drugs within 2 months.
2. Patients who must take ACEI or ARB due to other diseases.
3. Patients who have the history of allergy to allopurinol.
4. Unwillingness to follow the study protocol.
5. Active gout within 4 weeks.
6. Pregnancy or unwillingness to use contraception.
Piritrexim in Treating Patients With Advanced Cancer of the Urinary Tract

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase II trial to study the effectiveness of piritrexim in treating patients with advanced cancer of the urinary tract that has not responded to previous treatment.

OBJECTIVES: I. Evaluate the antineoplastic activity of piritrexim and its effect on the survival of patients with advanced urothelial carcinoma previously treated with systemic cytotoxic chemotherapy. II. Evaluate the toxicity of piritrexim in these patients.

OUTLINE: Patients receive piritrexim by mouth 3 times daily, 5 days a week, for 3 weeks followed by 1 week of rest. Patients with responding or stable disease continue treatment every 4 weeks until unacceptable toxicity or progression intervenes.

PROJECTED ACCRUAL: A maximum of 40 patients will be entered over 5-6 months if at least 1 response is observed in the first 14 evaluable patients.

Eligibility Criteria:
DISEASE CHARACTERISTICS: Histologically confirmed transitional cell carcinoma, squamous cell, or adenocarcinoma of the renal pelvis, ureter, bladder, or urethra Progressing regional or metastatic disease after one prior systemic or intra- arterial chemotherapy regimen Bidimensionally measurable disease, e. g.: Pulmonary nodules Palpable lymph nodes Cutaneous or subcutaneous nodules Mediastinal tumor or hepatic metastases if clearly measurable on CT No prior radiotherapy to indicator lesion unless documented progression since completion of radiotherapy

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0 or 1 Hematopoietic: (within 2 weeks prior to entry) WBC at least 4,000/mm3 Platelet count at least 100,000/mm3 Hepatic: (within 2 weeks prior to entry) Bilirubin no greater than 2.0 mg/dL AST no greater than twice normal Renal: (within 2 weeks prior to entry) Creatinine no greater than 1.5 mg/dL OR Creatinine clearance greater than 40 mL/min Other: No active unresolved infection No concurrent parenteral antibiotics At least 7 days since parenteral antibiotics No history of prior malignancy within 5 years except: Curatively treated nonmelanomatous skin cancer In situ cancer of the cervix Not pregnant or nursing Adequate contraception required of fertile patients Physically and medically able to take oral medications

PRIOR CONCURRENT THERAPY: Biologic therapy: One prior systemic biological response modifier therapy allowed At least 3 weeks since biologic response modifier therapy and recovered Chemotherapy: See Disease Characteristics At least 3 weeks since chemotherapy and recovered Endocrine therapy: Not specified Radiotherapy: At least 4 weeks since radiotherapy Surgery: At least 3 weeks since major surgery and recovered
Locally Invasive NSCLC Treated With NEo-Adjuvant Stereotactic Body RadioTherapy and REsection

Despite improved staging and operative techniques, the rate of incomplete resection (R1) of NSCLC has remained significant over the last decades. Patients with R1 resection have significantly worse survival compared to those with complete resection (R0).

This is a phase I study that investigates the feasibility and safety of delivering Stereotactic Body Radiotherapy (SBRT) to patients with locally invasive NSCLC (cT3-4, N0-1) who are at risk for incomplete resection.

Twenty patients with NSCLC will be treated with SBRT followed by surgery and appropriate adjuvant therapy. Patients will be divided into groups, of 5 patients each, treated with escalating doses (35, 40, 45 and 50 Gy) in 10 daily fractions.

The primary outcome is the feasibility i.e. the ability to complete safely SBRT and surgery (within 6 weeks). Secondary outcomes include acute and late adverse events, R0/R1/R2 rates and secondary surrogates of feasibility.

If successful, this study will lead to further evaluation of pre-operative SBRT in NSCLC.


Eligibility Criteria:
Inclusion Criteria:

* Patients will be included if they are aged 18 years or older,
* with biopsy proven NSCLC,
* clinically staged T3-T4 marginally resectable i.e. deemed at risk to achieve \<R0 resection (such as invasion of critical mediastinal or hilar structures, nodal extra-capsular extension, chest wall, vertebral bodies, compromised bronchial stump margin, based on CT images of the chest).
* Patients also need to be pathologically staged N0-1 disease,
* with an SBRT CTV≤200cm3, based on planning CT images.
* ECOG status is required to be \<2 within 4 weeks prior to registration and
* patients must be deemed medically operable by the surgical team.

Exclusion Criteria:

* Patients will be excluded if they are deemed medically inoperable by the surgical team
* and have a weight loss of ≥10% within 3 months prior to pathological diagnosis.
* Patients will also have no absolute contraindication to RT such as connective tissue disease, pacemaker-dependent patient with the pacemaker receiving higher than tolerance dose, had no had previous RT to the current region of the study, that would result in overlap of RT fields,
* patients must have no plans to receive other local therapy while on study, except at disease progression,
* patients have not had other malignancy within 2 years prior to the study (other than non-melanomatous skin cancers)
Investigation of the Effect of Scan Delay on the Measurement of Dental Prescale II

Dental Prescale II (GC Corp., Tokyo) is a pressure sensitive sheet for occlusal force measurement. According to the instruction, the patient need to bite the sheet for about 3 seconds and then the sheet will be scanned. But the delay response of coloring agent will influence the data collected and was noticed in vitro. To have a standard procedure, we need to know the time for scanning. This study will scan the sheet up to 2 hours and try to find the relation between the time the sheet scanned and the data collected.


Eligibility Criteria:
1. Inclusive criteria:

   * full dentition except third molar
   * healthy periodontal condition
   * can sign consent
2. Exclusive criteria:

   * history of temporomandibular disorders
Zephyr Valve Registry (ZEVR)

The purpose of this Post-Approval Registry is to gather ongoing safety and effectiveness assessment of the Zephyr Valve treatment in a real-world setting.

The Zephyr Valve Registry (ZEVR) is a multi-center, single-arm, prospective Registry. The objective of this Registry is to provide ongoing safety and effectiveness assessment of the Zephyr Valve treatment of patients with hyperinflation associated with severe emphysema, in regions of the lung that have little to no collateral ventilation.

Approximately 150 patients undergoing Zephyr Valve treatment in the commercial setting will be enrolled and followed out to 3 years. Assessments will be conducted at 45-days, 6-months, 12-months, 24-months and 36-months post-procedure. The Zephyr Valve Registry will be conducted at a minimum of 5, and a maximum of 10 clinical sites.

Subjects prescribed Zephyr Valve treatment for their emphysema will be consented and will be enrolled only after determination of little to no collateral ventilation between target and ipsilateral lobes. Safety and effectiveness of the Zephyr Valve treatment will be evaluated post-treatment based on data collected out to 3 years after the treatment.

Eligibility Criteria:
Inclusion Criteria:

* Subjects with severe emphysema considered appropriate for the procedure by the physician.
* Subjects who signed an Informed Consent Form to allow data collection.

Exclusion Criteria:

• Subjects determined to have collateral ventilation between the target(s) and ipsilateral lobe(s).
Initial Performance of a Modified Daily Disposable Contact Lens

The purpose of this study is to evaluate the incidence of ocular discomfort device-related adverse events with DAILIES TOTAL1® with UV Absorber (DT1 UV) contact lenses compared with current DAILIES TOTAL1® (DT1) contact lenses.


Eligibility Criteria:
Inclusion Criteria:

* Must sign an Informed Consent document;
* Current wearers of commercial DT1 lenses (for at least 3 months), with a minimum wearing time of 5 days per week and 8 hours per day;
* Spherical contact lens correction within the range of -2.00 to -4.00 Diopter (D) in both eyes;
* Manifest astigmatism less than or equal to 0.75 D (at screening);
* Best-corrected visual acuity (BCVA) greater than or equal to 20/25 in each eye (as determined by manifest refraction at screening);
* Other protocol-specified inclusion criteria may apply.

Exclusion Criteria:

* Eye injury in either eye within 12 weeks prior to study enrollment;
* Any anterior segment infection, inflammation, disease, or abnormality that contraindicates contact lens wear as determined by the Investigator;
* Use of systemic or ocular medications for which contact lens wear could be contraindicated, including topical ocular medications and lubrication drops that would require instillation during contact lens wear;
* History of herpetic keratitis;
* History of refractive surgery or irregular cornea;
* Pathologically dry eye that precludes contact lens wear;
* Concurrent participation (or within the previous 30 days) in a contact lens or lens care product clinical trial;
* Monocular (only 1 eye with functional vision);
* Other protocol-specified exclusion criteria may apply.
Atropine in Laparoscopic Gynaecological Surgery

This is a double blinded, randomised controlled trial that will compare atropine to placebo for postoperative pain in laparoscopic gynaecological surgery

Patients that meet eligibility criteria will receive a standardised general anesthesia based on sevoflurane and opioids and will be randomised in two groups, using computer generated randomisation system. Allocation concealment is established on opaque envelopes that contain random allocation.

Anesthesia depth will be measured by Bispectral index (BIS), titration of sevoflurane to a BIS of 45-60. In case of neuromuscular block reversal at the end of surgery, sugammadex will be administered.

At induction, 1 mg IV atropine 0.1% OR 10ml saline will be administered, depending on group allocation, on a syringe prepared by an anaesthesiologist not involved in the study.

Patients will receive ketorolac 30 mg/8h, acetaminophen 1g/8h and a morphine IV patient controlled anaesthesia pump (PCA) 0-1-8 Outcomes will be evaluated at the postoperative care unit (PACU) and 24 postoperative hours by an investigator blinded to study group

Eligibility Criteria:
Inclusion Criteria:

* American Society of Anesthesia (ASA) Class I-II, gynaecological laparoscopic surgery lasting ≥30' of laparoscopic time, BMI \<35

Exclusion Criteria:

* Known allergies to study drugs, concomitant surgeries, patients with closed angle glaucoma, history of coronary disease or heart insufficiency, beta.blockers
Preoperative Hemoglobin and Acute Kidney Injury in Emergency Surgery

Optimization of hemoglobin levels for organ perfusion is essential, especially in critically ill patients. Although anemia is associated with severe organ failure, especially in coronary artery disease, the effects of blood transfusion or various interventions to increase hemoglobin levels on outcomes continue to be debated. The effects of hemoglobin levels in emergency surgery patients on the development of postoperative AKI have been investigated in a small number of studies in the literature, and clear results have not yet been reported. This study was designed to evaluate the effect of hemoglobin levels on the development of AKI after adjustment for known predictive factors.

Acute kidney injury (AKI) is a common complication in patients undergoing major surgery and is associated with both short-term morbidity and mortality and long-term adverse outcomes including the development of Chronic Kidney Failure. Optimization of hemoglobin levels for organ perfusion is essential, especially in critically ill patients. Although anemia is associated with severe organ failure, especially in coronary artery disease, the effects of various interventions such as blood transfusion or increasing hemoglobin levels on outcomes continue to be debated. This prospective observational study was planned to evaluate the effect of hemoglobin levels before emergency surgery on the development of postoperative AKI.

Emergency operated patients will be divided into two groups as Group AKI and Group non-AKI according to the development of postoperative renal failure. Postoperative AKI diagnosis and severity will be evaluated according to serum creatinine and/or urine output according to KDIGO (Kidney Disease: Improving Global Outcomes criteria).

Demographic characteristics of the patients, preoperative complete blood count, blood biochemistry characteristics, hemodynamic variables, fluid replacement, blood and blood product replacements, surgical characteristics, development and severity of AKI in the postoperative period will be recorded and the effect of hemoglobin level on the development of AKI will be evaluated.

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing emergency non-cardiac surgery

Exclusion Criteria:

* Known renal failure
* Need for reoperation within 48 hours postoperatively
* Exit status within 48 hours postoperatively
* Known hematological disease
* Known kidney transplantation
* Urgent surgery planned due to urinary system related diseases
* Patients who did not accept to participate in the study
Postoperative Analgesia in Laminectomy

Compare the analgesic effects of naproxen sodium codeine, paracetamol codeine and placebo on postoperative pain and tramadol (Contramal) consumption during the first 24 hour after a lumbar disk surgery.

Compare the analgesic effects of naproxen sodium codeine paracetamol codeine and placebo on postoperative pain intensity measured by the visual analogue scale, and evaluated tramadol consumption and related side effects.

Eligibility Criteria:
Inclusion Criteria:

* American Society of Anesthesiologists (ASA) 1 or 2 status patients scheduled for an elective lumbar disc surgery

Exclusion Criteria:

* were known allergies to any of the drugs used in this study
* peptic ulcer disease
* hepatic and renal dysfunction,
* emergency surgery
* inability to provide informed consent
SGLT-2i and ARB Combination Therapy in Patients With T2DM and Nocturnal Hypertension (SACRA Study)

To explore the beneficial effects of 'empagliflozin + ARB' in comparison with 'placebo + ARB' on the reduction of nocturnal blood pressure in T2DM with hypertension

The study consists of a 8-week run-in period and a 12-week treatment period.

Eligibility Criteria:
Inclusion Criteria:

Patients who meet the following criteria at the start of treatment are eligible for the study:

* Receiving stable treatment with anti-hypertensive including ARB for at least 8 weeks at baseline (0W).
* Receiving stable anti-diabetic treatment with/without anti-diabetics for at least 8 weeks at baseline (0W).
* HbA1c\>=6.0%, \<10%
* Seated office SBP 130-159mmHg or DBP 80-99mmHg
* Nocturnal hypertension (SBP\>=115 mmHg) as measured by Home BP during 5days before baseline (0W).
* Age\>=20

Exclusion Criteria:

Patients who meet any of the following criteria are not eligible for the study:

* History of hypersensitivity to empagliflozin
* Breast-feeding, pregnant, possibly pregnant, or plan to become pregnant
* Treated with insulin or SU
* With renal dysfunction (eGFR\<45mL/min/1.73m2)
* With liver dysfunction (AST or ALT is 3 times higher than reference value)
* Hypotension (systolic blood pressure \< 90 mmHg)
* With pituitary gland dysfunction or adrenal gland dysfunction
* Heart failure patients whose NYHA class is IV
* Deemed ineligible for the study due to another reason by investigator
* History of diabetic ketoacidosis or diabetic come within 3 months before enrollment
* History of Acute myocardial infarction, unstable angina, cerebrovascular disease, or transient ischemic attack within 3 months before enrollment
* Patients who have undergone percutaneous transluminal coronary angioplasty (PCI) or coronary artery bypass graftin (CABG) within 3 months before enrollment
* Patients received SGLT2 inhibitor within 8 weeks before enrollment