cyrilzakka/clinical-trials huggingface dataset:
A Retrospective Study of Reco Thrombectomy Stent for Intravascular Treatment of Acute Ischemic Stroke

To explore the differences in the green channel process of stroke in various regions of the same province, to target and shorten the time delay of emergency process, and to explore the key technologies of endovascular treatment of acute ischemic stroke. To investigate the use and embolectomy effect of Reco, the first embolectomy stent in China, in economically developed areas. Health economic assessment (cost-benefit analysis) of ischemic stroke patients in various regions of the province.

The Reco Embolectomy Stent is indicated for patients who cannot be treated with intravenous tissue activator (IVt-PA) or who have failed IVt-PA therapy and is intended to remove thrombus from a large intracranial vessel in patients with ischemic stroke to restore blood flow.

Eligibility Criteria:
Inclusion Criteria:

* Patient age ≥18 years
* The clinical diagnosis was acute ischemic stroke
* Large vascular lesions were detected by head CT, CTA, MRI, MRA or DSA
* Preoperative baseline NIHSS score \> 4
* MRS 0-1 before this stroke
* Mechanical thrombectomy was performed
* Use Reco thrombectomy bracket

Exclusion Criteria:

* epileptic seizure
* Sudden coma
* Neurological loss symptoms quickly improved
* Imaging was negative, but clinical symptoms did not rule out subarachnoid hemorrhage
* Previous intracranial hemorrhage, subarachnoid hemorrhage, and brain tumor (with mass effect)
* History of head trauma within 3 months prior to surgery
* History of arterial puncture with difficulty in compression and hemostasis within one week prior to surgery
* Physical examination revealed evidence of active bleeding or trauma (e.g. fracture)
* Women are known to be pregnant or breastfeeding
* Severe allergies to contrast agents are known
Clinical Study of Tripterygium Capsule to Treat Early Ankylosing Spondylitis

This study is a 12-week, randomized, placebo and positive drug controlled clinical trial to investigate whether tripterygium capsule is effective and safe in treating patients with ankylosing spondylitis. The investigators expect that the tripterygium capsule is more effective than placebo and has few adverse effects.


Eligibility Criteria:
Inclusion Criteria:

1. Fulfill the ESSG criteria for SpA and not fulfill any criteria for the subtype including ankylosing spondylitis, psoriatic arthritis, reactive arthritis and inflammatory bowel disease associated arthritis.
2. Disease is in active status defined by BASDAI\>=40mm.
3. DMARDs administration must be suspended for at least 4 weeks before screening. NSAIDs dose must be stable for at least 4 weeks before screening.

Exclusion Criteria:

1. Intra-articular injection of glucocorticoid within 3 months.
2. Previous history of heart failure, multiple sclerosis, chronic obstructive pulmonary disease, recurrent infection, lymphoma or other tumors.
3. Accompanied by fibromyalgia syndrome or other rheumatic diseases.
4. Female of pregnancy or breast-feeding.
5. Poor compliance or with mental diseases.
Study of BTK Inhibitor LOXO-305 Versus Approved BTK Inhibitor Drugs in Patients With Mantle Cell Lymphoma (MCL)

This is a study for participants with a type of blood cancer called mantle cell lymphoma (MCL). The main purpose is to compare pirtobrutinib (LOXO-305) to other drugs that work in a similar way that have already been approved by the United States Food and Drug Administration (US FDA). Participation could last up to two years, and possibly longer, if the disease does not progress.

This is a Phase 3 global, randomized, open-label study comparing pirtobrutinib (Arm A) to investigator's choice of ibrutinib, acalabrutinib or zanubrutinib (Arm B) in MCL patients who have received 1 or more lines of therapy and are BTK inhibitor naïve.

Eligibility Criteria:
Inclusion Criteria:

* Confirmed MCL diagnosis
* Previously treated with at least one prior line of systemic therapy for MCL
* Measurable disease per Lugano criteria
* Eastern Cooperative Oncology Group (ECOG) 0-2
* Absolute neutrophil count ≥ 0.75 × 109/L without granulocyte-colony stimulating factor support within 7 days of screening
* Hemoglobin ≥ 8 g/dL not requiring transfusion support or growth factors within 7 days of screening
* Platelets ≥ 50 × 109/L not requiring transfusion support or growth factors within 7 days of screening.
* AST and ALT ≤ 3.0 x upper limit of normal (ULN)
* Total bilirubin ≤ 1.5 x ULN.
* Creatinine clearance of ≥ 30 mL/min according to Cockcroft/Gault Formula

Exclusion Criteria:

* Prior treatment with an approved or investigational BTK inhibitor
* History of bleeding diathesis
* History of stroke or intracranial hemorrhage within 6 months of randomization
* History of allogeneic or autologous stem cell transplant (SCT) or chimeric antigen receptor modified T-cell (CAR-T) therapy within 60 days of randomization
* Clinically significant cardiovascular disease
* Prolonged QT interval corrected using Fridericia's formula (QTcF) \> 470 ms on 2/3 consecutive ECGs, and mean QTcF\>470 ms on all 3 ECGs
* Known HIV infection or active HBV, HCV, or CMV infections. (Certain participants with controlled HBV infections may still be eligible)
* Clinically significant active malabsorption syndrome or other condition likely to affect gastrointestinal (GI) absorption
* Ongoing chronic treatment with strong cytochrome P450 3A4 (CYP3A4) inhibitors or inducers which cannot be stopped within 3-5 half lives of the CYP3A inhibitor therapy prior to start of study drug treatment.
* Patients requiring therapeutic anticoagulation with warfarin or another Vitamin K antagonist.
* Vaccination with live vaccine within 28 days prior to randomization
CP4ACS - Delphi Study to Determine Appropriateness of STEMI Quality Indicators in Belgium

RAND/UCLA modified Delphi study on quality indicators for STEMI to determine the appropriateness of quality indicators retrieved from literature and guideline review. We aim to engage 20 cardiologists and 20 nurses with relevant experience in the care for STEMI patients.


Eligibility Criteria:
Inclusion Criteria:

* cardiologist or cardio nurse with relevant experience in the care for STEMI patients

Exclusion Criteria:

-
Bikini vs Longitudinal Incision in Direct Anterior Approach (DAA) Total Hip Arthroplasty (THA)

The study team is conducting this study to see if there is a difference between the wound healing and participant satisfaction rates between two incision types used during a THA done via the DAA technique.


Eligibility Criteria:
Inclusion Criteria:

* Patients with body mass index greater than or equal to 30
* Patients undergoing primary unilateral DAA THA
* Patients undergoing primary THA

Exclusion Criteria:

* Patients with body mass index less than 30
* Patients with a history of prior open surgery on the affected hip
* Patients unable/unwilling to undergo spinal anesthesia under monitored anesthesia care (MAC)
* Patients with allergies or absolute contraindication to standardized drugs administered within the University of Miami protocol for total hip replacement
* The following groups will not be included: adults unable to consent, individuals who are not yet adults, pregnant women, prisoners.
Renal Effects of Hormones/Biomarkers in Transgender PrEP Recipients

Will use a subset of the main study cohort of transgender or non-binary individuals to evaluate the relationships between self-reported exogenous hormone use, endogenous hormone values, renal biomarkers, drug levels and directly measured renal function.

This cross-sectional sub-study will use a subset of the main study cohort of transgender (TG) or non-binary (NB) individuals to evaluate the relationships between self-reported exogenous hormone use, endogenous hormone values (serum estradiol, estrone, free/total testosterone), renal biomarkers, drug levels (measured by tenofovir diphosphate, TFV-DP, and emtricitabine triphosphate, FTC-TP, on dried blood spot cards and urine) and directly measured renal function (iohexol clearance).

Eligibility Criteria:
Inclusion Criteria:

* HIV-uninfected
* Identifying as transgender or nonbinary (TG/NB)
* Age ≥ 18 years (adult)
* At risk of acquiring HIV
* Calculated creatinine clearance (CRCL) ≥ 60 mL/minute
* Taking emtricitabine/tenofovir alafenamide
* Willing to receive a small dose of iohexol
* Willing to provide 30 mL blood and a urine sample

Exclusion Criteria:

* Allergy to iohexol
* Use of concurrent medications that may interfere with iohexol such as metformin, amiodarone or beta-blockers
* Anuric or unable to produce 30 mL of urine
* Other condition that, in the opinion of the investigator, would put the participant at risk, complicate interpretation of study outcome data, or would otherwise interfere with participation or achieving the study objectives
Gastric Emptying in Elderly With Hip Fracture

The gastric emptying of 400 ml 12.6% carbohydrate rich drink is investigated in elderly women, age 75-100, with acute hip fracture. The emptying time will be assessed by the paracetamol absorption technique, and lag phase and gastric half-emptying time compared with two gender-matched reference groups: elective hip replacement patients, age 45-71, and healthy volunteers, age 28-55.

Patients with hip fracture are submitted to prolonged fasting before surgery is undertaken. This is deleterious for their metabolic condition and slows recovery after surgery.

A carbohydrate-rich beverage is taken immediately before surgery and gastric emptying rate is assessed in elderly (75-100 yo) women prior to surgery for acute hip fracture. As comparator another two groups of women are used; one scheduled for elective surgery for hip replacement due to osteoarthritis; another healthy female volunteers.

On the day of surgery the primary study group of acute hip fracture is given a carbohydrate-rich beverage 400 ml, total 200 kcal in combination with paracetamol 1.5 g. Blood samples are intermittently drawn during 180 minutes to measure recovery of paracetamol in plasma and gastric emptying rate calculated according to previously published principles. In the same manner a group of women on waiting list for hip replacement surgery due to osteoarthritis are enrolled for estimation of gastric emptying rate. In addition, another group of completely healthy women are enrolled for assessment of gastric emptying.

Eligibility Criteria:
Inclusion Criteria:

* female gender, age 75 years or above, and hip fracture within 24 hours of admission.

Exclusion Criteria:

* gastro-esophageal reflux disease, peptic ulcer disease, gastrointestinal motility disorder, pulmonary or cardiac disease, pharmacological treatment with motility-stimulating agents such as dopamine-receptor blockers or macrolides, as well as previous long-term opioids or acid inhibitory agents, or cognitive impairment at the discretion of the investigator
A Study to Evaluate the Tolerance and Pharmacokinetics of TQB3720 Tablets

This study is conducted to investigate the pharmacokinetic and safety profiles of TQB3720 in patients with metastatic castration-resistant prostate cancer.


Eligibility Criteria:
Inclusion Criteria:

* 1. Histologically or cytologically confirmed prostate carcinoma. 2.Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 2; Life expectancy ≥12 weeks.

  3.Testosterone levels \< 50 ng/dL. 4. Has received ≥1 previous regimens for metastatic castration-resistant prostate cancer.

  5.Male subjects should agree to use an adequate method of contraception starting with signing ICF through 6 months after the last dose of study.

  6.Understood and signed an informed consent form.

Exclusion Criteria:

-1.Has symptomatic brain metastases or control of symptoms \< 1 month. 2.Has other malignancies within 3 years. 3.Has used second-generation androgen receptor antagonists. 4. Abnormal liver function. 5. Abnormal renal function. 6. Has received any other investigational drug within 30 days weeks before first dose.

7. According to the judgement of the researchers, there are other factors that subjects are not suitable for the study.
The Relation Between Uric Acid Level and Endothelial Dysfunction in Patients With Polycystic Kidney Disease

There are substantial data demonstrating increased endothelial dysfunction, inflammation and oxidative stress in patients with Autosomal dominant polycystic kidney disease (ADPKD), the association between serum uric acid level and endothelial dysfunction has not been elucidated yet in these patients. Therefore, in this study, the investigators aimed to examine the relationship between the uric acid level and the ED in normotensive ADPKD patients with preserved renal function.

This is the first study to evaluate the relationship between uric acid and endothelial dysfunction in patients with early stage ADPKD

Eligibility Criteria:
Inclusion Criteria:

* ADPKD patients with normal renal function,
* Normotensive ADPKD patients

Exclusion Criteria:

* Patients with impaired kidney function,
* Atherosclerotic disorders,
* Diagnosis of hypertension, gout, diabetes,
* Using of insulin, thiazide, allopurinol or uricosuric drugs
Prevalence and Characterization of Persistent Dyspnea After Hospitalization

The investigators aim to make an overview of persistent dyspnea at the end of an hospitalization for a respiratory disease using an actual tool, the Multidisciplinary Dyspnea Profile questionnaire.


Eligibility Criteria:
Inclusion Criteria:

* Age over 18 years old
* Able to respond the questionnaire
* Presenting at admission a dyspnea over 3/10 on numerical analogic scale
* Admitted for a respiratory cause

Exclusion Criteria:

* cognitive impairment
* aphasia
* no french-speaking person
Efficacy and Safety of Dexmedetomidine Added to Modified Pectoral's Block in Breast Cancer Patients

To Evaluate the effect of addition of Dexmedetomedine to ultrasound guided modified Pecs block on post operative analgesia \& stress response in patient undergoing modified radical mastectomy.

60 patients (age ≥29 years) who scheduled for modified radical mastectomy surgery under general anesthesia. Group I (Bupivacaine group): patients underwent modified radical mastectomy were given preoperative ultrasound guided modified Pecs block with 30 mL of 0.25% bupivacaine divided into 10 ml injected between the pectoralis muscles on the interfasial plane, and 20 ml injected between the Pectoralis minor muscle and the serratus muscle.Group II (Bupivacaine + Dexmedetomidine group) : preoperative ultrasound guided modified Pecs block with 30 mL of 0.25% bupivacaine plus Dexmedetomidine (1 µg/kg) divided into 20 ml injected between the pectoralis muscles on the interfasial plane , and 10 ml injected between the Pectoralis minor muscle and the serratus muscle.

Eligibility Criteria:
Inclusion Criteria:

* ASA I - II patients
* weight 50- 100 kg)

Exclusion Criteria:

* a history of bleeding diathesis,
* relevant drug allergy
* opioid dependence,
* sepsis,
* those with psychiatric illnesses
Long-Term Safety Evaluation Of Treatment Of Constipation Due To Opioids Being Taken For Persistent Non-Cancer Pain

Adults who are taking opioid therapy for persistent non-cancer pain and have resulting opioid-induced bowel dysfunction (OBD) will be randomized (1:1) to alvimopan or placebo. The primary objective of this Phase 3 long-term safety study is to compare alvimopan with placebo for safety and tolerability in the treatment of OBD. Participants will be required to attend 8 clinic visits over approximately 1 year.


Eligibility Criteria:
Inclusion criteria:

* Consented to participate in this study.
* Taking opioid therapy for persistent non-cancer pain.
* Has bowel dysfunction mainly due to opioids.
* Has bowel dysfunction since starting opioids as defined by infrequent bowel movements and additional bowel-related symptoms.
* Willing to discontinue laxative therapy (will be provided study-specific standardized laxative if needed).

Exclusion criteria:

* Pregnant, lactating, or planning to become pregnant.
* Not ambulatory.
* Participated in another trial with an investigational drug in the past 30 days.
* Taking opioids for the management of drug addiction or cancer-related pain.
* Severe constipation whereby the subject is at immediate risk of developing serious complications of constipation.
* Gastrointestinal or pelvic disorders known to affect bowel transit, produce gastrointestinal (GI) obstruction, or contribute to bowel dysfunction.
* Human Immunodeficiency Virus (HIV)-infected, has active hepatitis, or has ever been infected with hepatitis C.
Zero Ischemia Laparoscopic Partial Nephrectomy

Laparoscopic partial nephrectomy (LPN) is often reserved for patients with a small peripheral tumour, in the hands of an experienced surgeon since it demands a high degree of endoscopic skill. Renal vessel clamp for vascular control is a required step during standard LPN. However, this creates a time limiting step for the surgeon and induces renal injury via warm ischemia and reperfusion injury. This novel approach can substantially reduce renal injury during LPN via superselective embolization of level II renal arteries pre-operatively. This technique facilitates the performance of a clamp-less, zero-ischemia LPN, significantly simplifying the procedure by remove time thresholds within which to perform tumor excision. The preliminary results are promising; however, there is a need for further corroboration of their results, in addition to a randomized controlled trial comparing this modified, zero ischemia technique with standard LPN.

The potential utility of a zero ischemia, laparoscopic, partial nephrectomy portends significant implications for both the surgeon and patient. Firstly, the technical difficulty of a partial nephrectomy will be reduced to a more achievable level owing mainly to the removal of a time limit on surgical resection. With the blood flow halted to downstream tissue containing the renal neoplasm from preoperative embolization, resection can be made to the tumor without clamping of the main renal arteries. This minimizes the ischemic time to non-neoplastic renal tissue, allowing for a renal protective effect. Without the need for clamping, the overall surgical operative time is drastically reduced. With excision made at the ischemic tissue, intra-operative bleeding and ease can be achieved. More surgeons can ultimately attempt at LPN by removing the single most limiting surgical factor, warm ischemic time.

Eligibility Criteria:
Inclusion Criteria:

* T1a renal cell carcinomas diagnosed by ultrasonography (US), computed tomography (CT) or fine needle aspiration
* tumor size \<4cm in diameter
* predominant exophytic growth
* intraparenchymal depth no greater than 1.5cm, with a minimum distance of 5mm from the urinary collecting system

Exclusion Criteria:

* predominant endophytic nature (depth \</= 1.5 cm)
* nearness (\<0.5cm) of the tumor to the urinary collecting system
* multiple ipsilateral lesions
* pregnancy
* allergy to intravenous contrast dye
* absolute contraindications to surgical intervention
Different Inflammatory Biomarkers With Surgical Removal of Mandibular Third Molars

Removal of mandibular third molars (M3s) is the most frequently performed surgical intervention undertaken in dentistry. The indications and timing of surgical removal of M3s has been a matter of international and national debate, and especially prophylactic removal of M3s is controversial.

Removal of mandibular third molars (M3s) is the most frequently performed surgical intervention undertaken in dentistry. The indications and timing of surgical removal of M3s has been a matter of international and national debate, and especially prophylactic removal of M3s is controversial.

It is well documented that periodontally compromised patients are characterized by elevated levels of systemic low-grade inflammation which can affect their general health and contribute to development and aggravation of a number of chronic diseases including diabetes mellitus and cardiovascular disorders. Inflammatory changes are frequent around erupted, semi-erupted and retained M3s. However, only a few under-powered studies have addressed the relationship between the presence of M3s and the level of systemic low-grade inflammation.

Conservative guidelines recommend not to remove M3s until subjective and/or objective signs of infection are observed. Overall, these guidelines result in a relatively equal distribution of surgically removed M3s over the age span of a population. In contrast, more proactive guidelines recommend removal of M3s that are not expected to erupt into functional occlusion leading to frequent removal of M3s in the young population. Surgical removal of M3s are associated with a varying degree of pain, facial swelling and the patients are on average sick leave for 2-3 days. Furthermore, complications as nerve damage, infection, bleeding and jaw fracture can occur. Therefore, unnecessary removal of M3s should be avoided. However, the risk and severity of postoperative sequelae and complications is known to increase significantly with age. Hence, the crucial point determining indications for surgical removal of M3s is to balance the risk of developing local and systemic disease against the risk of complications after surgical removal.

The present project will investigate the systemic impact of retaining or removing M3s by measuring low-grade systemic inflammation markers in blood and saliva. To further explore measures to reduce postoperative complications, discomfort, and patient satisfaction, the effect of prophylactic antibiotics, pre-emptive analgesics, and a postoperative follow-up telephone call, will be investigated.

The project consists of six prospective studies that will include more than 800 patients and surgical removal of more than 1,000 mandibular third molars. It is expected that the project will contribute with important information on the impact of mandibular third molars on general health and prophylactic modalities that can influence postoperative sequelae and complications following surgical removal of mandibular third molars.

Eligibility Criteria:
Inclusion Criteria:

* Wisdom teeth

Exclusion Criteria:

* No wisdom teeth