cyrilzakka/clinical-trials huggingface dataset:
The Effect of Blood Pressure on the Postoperative Cognitive Dysfunction

Permanent and temporary cognitive impairment in the perioperative period is of great importance to patients. Hypoperfusion due to the intraoperative hypotension is often mentioned as a possible cause of postoperative cognitive dysfunction.

All patients aged above 60 years undergoing planned spinal surgery in the prone position in the duration of 1-3 hours under general anesthesia will be included in the study. In group L (liberal), the value of blood pressure will be corrected with the change of mean arterial pressure (MAP) ± 25% patient's mean arterial pressure, and group R (restrictive) with the change of MAP ± 10%. Cognitive dysfunction tests will be executed on the day before the surgery, two hours after the surgery and on the third postoperative day. Anesthesia will be managed according to the standardised protocol. Concentration of desflurane will be adjusted according to entropy values (target 40-50). Analgetics will be applied according to surgical pleth index (SPI) values. Sufentanil will not be applied in the last 15 minutes. Extubation will be performed at the operating theatre when meeting all extubation criteria including train of four ratio (TOFR) above 92%. Neither syntophyllin, nor pharmacological decurarization (syntostigmin) will be applied to the patients.

Eligibility Criteria:
Inclusion Criteria:

* GCS 15
* ASA risk I - III
* planned spinal surgery in the prone position
* duration of the procedure of 1-3 hours

Exclusion Criteria:

* hypertension above 180/100 torr preoperatively
* blood pressure below 130/80 torr preoperatively
Efficacy of TEAS on Postoperative Pain and Recovery in Patients Undergoing Pancreatectomy

The purpose of this study is to access the effect of transcutaneous electrical acupoint stimulation on postoperative pain in patients undergoing pancreatectomy

Patients who meet the enrollment criteria will be randomized 1:1 to either the transcutaneous electrical acupoint stimulation (TEAS) or the sham groups. In the TEAS group, the acupoints are bilateral neiguan (PC6) and Zusanli (ST 36) acupoints. Patients will receive TEAS 30min before anesthesia until being discharged from the postanaesthesia care unit (PACU). The same treatment for 30 min will be performed on the 1st, 2nd and 3rd days after surgery. The stimulation intensity will be adjusted in accordance with the maximal level tolerated by each patient.

Patients in the sham group will receive electrode attachment but without stimulation.

Eligibility Criteria:
Inclusion Criteria:

Age 18-80 years old; ASA physical status class I - III; Patients scheduled for pancreatectomy.

Exclusion Criteria:

Have a history of epilepsy; Rash or local infection over the acupoint stimulation skin area; Pregnancy or breastfeeding; Mental retardation, psychiatric, or neurological disease; Inability to comprehend the numeric rating scale (NRS); Implantation of a cardiac pacemaker, cardioverter, or defibrillator; Chronic opioid use; Metastases in other organs; Have a history of Transcutaneous Electrical Acupuncture Stimulation (TEAS) or electroacupuncture treatment in the past or recently；
Bendamustine Plus Rituximab (BR) for Relapsed or Progressive Marginal Zone B-cell Lymphoma (MZBCL)

This study will be conducted to evaluate the efficacy of Bendamustine Plus Rituximab (BR) in patients with relapsed or progressive Marginal Zone B-cell Lymphoma (MZBCL).

Multi-center trial, Phase II, non-randomized, open-label, single-arm study with combined therapy of bendamustine and rituximab in patients with MZBCL who has relapsed or progressive to prior chemotherapy or chemo-radiotherapy.

Eligibility Criteria:
Inclusion Criteria:

1. Histologically confirmed CD20-positive nodal or extranodal MZBCL
2. MZBCL patients who relapsed or progressed:

   * At least one and a maximum of four prior lines of chemotherapy
   * During or after the last chemotherapy or radiotherapy or
   * Without progression within 6 months of the last dose of rituximab-based regimen
3. Patients age ≥ 18 years
4. ECOG PS 0-2
5. At least one bidimensionally measurable disease
6. Adequate hematologic, renal, and hepatic functions
7. Women of child-bearing potential should use two appropriate methods of contraception during the study
8. Written informed consent

Exclusion Criteria:

1. Not all of the above inclusion criteria are met.
2. Prior chemotherapy within 4 weeks or radiotherapy within 6 weeks
3. Corticosteroids during last 28 days except chronic administration of prednisolone at a dose of \< 20mg/day for indications other than lymphomas
4. Evidence of CNS involvement by lymphomas
5. Active HBV/HCV infections, known HIV infection
6. Prior diagnosis of cancers within 5 years, except cervical intraepithelial neoplasia type 1, localized non-melanoma skin cancer, or small differentiated thyroid cancer
7. Serious concurrent disease:
8. Patients who are pregnant or lactating
Part 1 - A Clinical Trial in Patients With Frequently Relapsing and Steroid-Dependent Nephrotic Syndrome

A Clinical Trial Investigating the Safety and Efficacy of ADX-629 in Subjects with Frequently Relapsing and Steroid-Dependent Nephrotic Syndrome

ADX-629-MCD-001 is a multi-center, two-part, Phase 2 clinical trial designed to evaluate the safety and efficacy of ADX-629 in Subjects with frequently relapsing and steroid-dependent nephrotic syndrome. Study drug will be administered orally every 12 hours (twice daily) to eligible subjects for 90 days. The study will enroll approximately 35 children and adults with nephrotic syndrome who have had a nephrotic relapse in the 6 months prior to screening.

The clinical trial is divided into 2 parts: Part 1 (open-label) and Part 2 (double-blinded, randomized).

Part 1: Approximately 5 eligible subjects will receive open-label ADX-629 (250 mg) twice daily for 90 days.

Part 2: Approximately 30 eligible subjects will be randomized in a 2:1 ratio to receive either ADX-629 (250 mg) or matching placebo twice daily for 90 days.

Patients who are interested in participating will be provided detailed information about the study including description of study assessments/procedures, possible side-effects, alternative treatments, and potential benefits.

Eligibility Criteria:
Inclusion Criteria:

* Adults ≥18 years of age
* History of nephrotic syndrome, characterized by heavy proteinuria and hypoalbuminemia
* Recent nephrotic relapse in the 6 months prior to screening
* Estimated glomerular filtration rate (eGFR) of ≥45 during screening
* Not pregnant, breastfeeding, or lactating and agree to use a highly effective method of acceptable contraceptive for the trial duration, if applicable

Exclusion Criteria:

* Subjects with collapsing FSGS focal segmental glomerulosclerosis (FSGS)
* Known secondary cause of nephrotic syndrome (e.g., diabetic nephropathy, systemic lupus erythematous, sickle cell anemia, malignancy, drug-induced, malaria)
* History of kidney transplantation or other solid organ transplantation
* History of any unstable chronic diseases/conditions, clinically significant abnormalities, or findings, that in the opinion of the Investigator, could compromise subject safety or affect the conduct of the trial
A Study of Xeloda (Capecitabine) in Patients With Advanced and/or Metastatic Colorectal Cancer

This study will assess the efficacy and safety of continuous oral Xeloda administration in combination with intravenous irinotecan as a first-line treatment in patients with advanced and/or metastatic colorectal cancer. The anticipated time on study treatment is 3-12 months and the target sample size is \<100 individuals.


Eligibility Criteria:
Inclusion Criteria:

* adult patients \>=18 years of age;
* locally advanced and/or metastatic colorectal cancer;
* \>=1 target lesion.

Exclusion Criteria:

* previous treatment with Xeloda or irinotecan;
* previous systemic therapy for metastatic disease;
* progressive disease during previous adjuvant therapy or within 6 months of completion.
Pilot Study of Strepic® Device for the Diagnosis of Group A Streptococcal Pharyngitis

The objective of this pilot study is to acquire images using the Strepic® device, a clinical prototype that has been designed specifically as a viable, low-cost, commercially realizable autofluorescence-based diagnostic test, using (1) fluorescence and (2) white light image data, as well as other clinical data points. By acquiring and analyzing the images of pharyngeal bacterial fluorescence and white light patterns in patients with Group A Streptococcus (GAS)-associated pharyngitis and comparing them with those observed in non-GAS pharyngitis, it is believed an algorithm can be developed such that the device will improve the ability of clinicians to quickly and accurately identify GAS infections.


Eligibility Criteria:
Inclusion Criteria:

1. All patients aged 7-64 years of age with suspected GAS pharyngitis with modified Centor (McIsaac) score ≥2; and
2. Patient agrees to participate in study and patient or parent/guardian sign consent/assent form.

Exclusion Criteria:

1. Pharyngeal swab performed immediately prior to study team approach;
2. Prior enrollment in this study;
3. Pharyngeal symptoms \>7 days;
4. Peritonsillar abscess;
5. Antibiotic use within one week of index visit;
6. Inability to open mouth to visualize the pharynx; and
7. Inability to understand English or Spanish, as study forms including consent and assent forms will be written in English and Spanish;
8. Woman who is pregnant (self-reported, pregnancy test will not be performed) or nursing;
9. Current prisoner (define as an individual involuntarily confined in a penal institution, including persons: (1) sentenced under a criminal or civil statue; (2) detained pending arraignment, trial, or sentencing; and (3) detained in other facilities (e.g., for drug detoxification or treatment of alcoholism) under statutes or commitment procedures providing such alternatives to criminal prosecution or incarceration in a penal institution).
Evaluation of Clinical Efficacy of Herbal Compound in the Treatment of NSLBP

The aim of this randomized controlled trial was to explore the clinical efficacy and safety of HXTL in the treatment of NSLBP based on TCM principles and to compare the clinical outcomes of different syndromes of NSLBP with celecoxib.In this study, 80 patients with NSLBP were recruited and randomly grouped to use TCM compound and celeoxib respectively for intervention. The pain status and lumbar function use scale of patients were scored before intervention, 1 week, 2 weeks and 3 weeks after intervention, and the adverse reactions of patients after medication were recorded, and the clinical efficacy of the two groups of patients was compared finally.


Eligibility Criteria:
Inclusion Criteria:

* a. Patients with low back pain who were seen between January 1, 2022 and June 16, 2023 were included;
* b. meet the diagnostic criteria of NSLBP;
* c. the age range was 20-90 years old;
* d. agree to participate in the study and sign the informed consent;

Exclusion Criteria:

* a. those who are unable to communicate normally, such as those suffering from mental and cognitive diseases, and cannot cooperate with the treatment;
* b. pregnant or lactating women;
* c. patients who are allergic to the treatment components or sulfonamides;
* d. patients with a history of coronary artery bypass grafting;
* e. patients with active gastrointestinal ulcer or bleeding;
* f. patients with severe heart failure;
* g. Patients with hepatic and renal insufficiency.
Tracking Optical Coherence Tomography

The purpose of this research study is to evaluate an investigational system that may allow doctors to show images of the different parts inside the eye that show greater detail than current equipment can produce.

The purpose of this research study is to evaluate an investigational system that may allow doctors to make images of the parts inside the eye that show greater detail than current equipment can produce.

Eligibility Criteria:
Inclusion Criteria:

* Healthy individuals (this includes women of child-bearing potential) who are familiar with vision experiments and ophthalmic equipment, all over 18 years.
* Subjects will have a retinal screening if they are over 50 years old or have a known risk factor for eye disease, such as family history of age related macular degeneration or cardiovascular disease.
* Patients with retinal and choroidal disease: age related maculopathy or age related macular degeneration, diabetic retinopathy, glaucoma.

Exclusion Criteria:

* Over 85 years old
Hypofractionated WPPT With HDR Boost

This is a phase II study of ultrahypofractionated whole pelvis proton therapy with brachytherapy boost for patients with high risk or unfavorable intermediate risk prostate with elevated risk of lymph node involvement.


Eligibility Criteria:
Inclusion Criteria:

* Pathologic evidence of prostate cancer
* Risk group: high or intermediate risk as defined below

  * High risk: T3a or Gleason Grade Group 4/5 or PSA \>20
  * Unfavorable intermediate risk disease: at least one or more of the following: T2b-T2c, Gleason Grade Group 2/3, PSA 10-20, \>50% of cores positive
* Must be appropriate for whole pelvis per the treating oncologist or based on lymph node predicting nomogram
* Patient is a candidate for definitive external beam radiotherapy:

  * No prior radiotherapy in the region of study
  * No inflammatory bowel disease, active collagen/vascular/connective tissue disorders
* Age ³18 years
* ECOG performance status: 0-2
* Patients may initiate androgen deprivation therapy up to 3 months prior to radiation start, concurrently, or up to 3 months after completion of radiation therapy start. Patients may have received androgen deprivation therapy for the following months: unfavorable intermediate risk patients for 6 months; high-risk patients for 24 months. Patients will be allowed to discontinue ADT at physician and patient discretion.
* Pretreatment evaluation

  * History \& Physical by a radiation oncologist within 6 weeks of enrollment
  * MRI prostate
  * PSMA PET
  * PSA level
* Eligible for rectal spacer procedure as determined by treating physician
* Informed consent: Patients must have the ability to understand and be willing to sign the study-specific informed consent indicating their understanding of the investigational nature and the risks of this study before any of the protocol related studies are performed (this does not include routine laboratory testing or imaging studies required to establish study eligibility);

Exclusion Criteria:

* Evidence of distant metastatic disease
* History of inflammatory bowel or active collagen/vascular/connective tissue disorders
* Prior radiation to the pelvis
* Prior or concurrent second invasive malignancy other than non-melanoma skin cancers, unless disease free for minimum of five years
* Known severe, active co-morbidity, defined as follows:

  o Any clinically significant unrelated systemic illness, medical condition, or other factor, which at the discretion of the Principal Investigators, would interfere in the safe and timely completion of study procedures, compromise the patient's ability to tolerate the protocol therapy, or is likely to interfere with the study procedures or results.
* Patients should not have a prior history of TURP
* Patients should not have pre-treatment IPSS \>20 or on maximum alpha-blocker medications at baseline
* Patients should not be on therapeutic anticoagulation
Valsartan and Amlodipine in Blood Pressure Management: Fixed-Dose vs. Free Drug Therapy

Patients aged 35 to 70 years with newly diagnosed stage 1 or 2 hypertension ( HTN) was randomized to receive either Valsartan 80 mg/Amlodipine 5 mg fix dose combination (FDC) or a free equivalent combination. Ambulatory blood pressure monitoring at baseline and 8 weeks post-treatment initiation was performed.

Patients were eligible for enrollment if they were between 35 and 70 years old and diagnosed with stage 1 or 2 hypertension at the time of enrollment, according to the 2017 ACC/AHA Guidelines (systolic blood pressure \> 130 mmHg and/or diastolic blood pressure \> 80 mmHg), and required the initiation of antihypertensive medications.

This study used the permutation block randomization method (block size = 4) for the randomization process.Patients were randomly assigned to either the FDC group or the free equivalent combination group.

Eligible patients underwent an 8-week period during which they received either Valsartan 80 mg and Amlodipine 5 mg as an FDC or as free equivalent combinations. The FDC group received one single tablet daily, while the free combination group received the medications on separate tablets (amlodipine daily and Valsartan in the evening). 24-hour ambulatory blood pressure monitoring (ABPM) at the time of inclusion and at the end of the 8-week period were performed using a standard ABPM device that the patients wore with an appropriately sized cuff.

Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with stage 1 or 2 hypertension at the time of enrollment, according to the 2017 ACC/AHA Guidelines (systolic blood pressure \> 130 mmHg and/or diastolic blood pressure \> 80 mmHg), and required the initiation of antihypertensive medications

Exclusion Criteria:

* Patients previously been on antihypertensive drugs
* Patients had secondary high blood pressure
* Patients had severe high blood pressure (systolic blood pressure \> 180 mmHg and/or diastolic blood pressure \> 110 mmHg)
* Patients had ischemic heart disease in the past
* Patients were unable to receive any part of the treatment
* Patients who refuse to take part in study
Model 20066 Left Ventricular (LV) Lead Study

Heart failure is a progressive disease that decreases the pumping action of the heart. This may cause a backup of fluid in the heart and may result in heart beat changes. When there are changes in the heart beat sometimes an implantable heart device is used to control the rate and rhythm of the heart beat. In certain heart failure cases, when the two lower chambers of the heart no longer beat in a coordinated manner, cardiac resynchronization therapy (CRT) may be prescribed. CRT is similar to a pacemaker. It is placed (implanted) under the skin of the upper chest. CRT is delivered as tiny electrical pulses to the right and left ventricles through three leads (flexible insulated wires) that are inserted through the veins to the heart. The purpose of this study is to evaluate a new lead for delivering energy to the left ventricle (bottom left chamber of the heart).


Eligibility Criteria:
Inclusion Criteria:

* Patient meets CRT inclusion criteria as determined by local regulatory and/or hospital policy
* Patient has signed and dated the study-specific informed consent form
* Patient is 18 years of age or older
* Patient is expected to remain available for follow-ups at the investigational center
* Patient is willing and able to comply with protocol

Exclusion Criteria:

* Patient has a previous complete atrial based biventricular CRT system
* Patient has a previous LV lead implanted or previous implant attempt within 30 days of implant or ongoing Adverse Events from previous unsuccessful attempt
* Patient has known coronary venous vasculature that is inadequate for lead placement
* Patient has unstable angina pectoris or has had an acute myocardial infarction (MI) within the past month
* Patient has had a coronary artery bypass graft (CABG) or percutaneous transluminal coronary angioplasty (PTCA) within the past three months
* Patient has chronic (permanent) atrial arrhythmias
* Patient has contraindications for standard transvenous cardiac pacing (e.g., mechanical right heart valve)
* Patient has had a heart transplant (patients waiting for heart transplants are allowed in the study)
* Patient is enrolled in any concurrent drug and/or device study that may confound the results of this study
* Patient has a terminal illness and is not expected to survive more than three months
* Patient meets exclusion criteria required by local law (e.g. age, incompetence, pregnancy, breast feeding, etc).
* Patient is unable to tolerate an urgent thoracotomy
A Study of Naldemedine in Participants Undergoing Surgeries That Include a Bowel Resection or Bowel Transection

The objective of this study is to compare the efficacy of naldemedine versus placebo and to assess its effect on the time to gastrointestinal (GI) recovery following surgeries that include bowel resection and bowel transection.


Eligibility Criteria:
Inclusion Criteria:

* Scheduled to undergo 1 of the following procedures via open (nonlaparoscopic) surgery under general anesthesia:

  * partial small or large bowel resection with primary anastomosis
  * radical cystectomy requiring bowel transection with primary anastomosis
* Planned to be managed postoperatively with an enhanced recovery protocol, which, at a minimum, includes all of the following elements:

  * early removal of the nasogastric tube, which is defined as removal of the nasogastric tube at the end of surgery
  * early ambulation, which is defined as ambulation on Day 1
  * early diet advancement on Day 1
* Planned to receive primary postoperative pain management with opioid analgesia administered by any route.
* American Society of Anesthesiologists (ASA) Physical Status Score of I, II, or III (a normal healthy participant, a participant with mild systemic disease, and a participant with systemic disease, respectively).

Exclusion Criteria:

* Scheduled to undergo a total colectomy or any procedure that results in a colostomy or ileostomy.
* Scheduled for endoscopic or laparoscopic surgery.
* Complete bowel obstruction.
* Complicated inflammatory bowel disease (such as ulcerative colitis or Crohn's disease).
* More than 2 major abdominal surgery (for example, gastrectomy, gastric bypass, gastric sleeve, lap banding, pancreatic resection, hepatectomy, intestinal transplant).
* More than 3 doses of an opioid (regardless of the route of administration) during the 7 days prior to surgery.
* Pregnancy or lactation.
* Presence of peritoneal catheter (for example, for dialysis or chemotherapy).
Add-on Complex Ayurvedic Treatment in Fibromyalgia-Syndrome Compared to Standard Care Alone

The aim of this study is to evaluate the effectiveness of an additive complex āyurvedic diagnosis and treatment compared to conventional standard care alone in stationary patients with Fibromyalgia Syndrome.


Eligibility Criteria:
Inclusion Criteria:

* informed consent
* age between 18 and 70 years
* FMS according to current guidelines

Exclusion Criteria:

* change of pharmacological FMS treatment \>= 6 weeks before inclusion
* pregnancy or breat feeding
* acute psychiatric condition
* severe acute somatic disease
* severechronic comorbidity
* obesity WHO \>= II degree
* bloodcoagulation-disease
* intake of opiods
* current treatment with hyperthermia
* simultaneous participant in other trial
* praticipation in other trial during 6 month before inclusion