cyrilzakka/clinical-trials huggingface dataset:
ACE-inhibitors in Extracapillary Glomerulonephritis

The natural course of extracapillary glomerulonephritis is severe leading to End-Stage Renal Disease (ESRD) or death in most cases. Despite immunosuppressive treatment, long-term renal outcome remains poor since active crescents usually progress to fibrotic scars with glomerular occlusion and disruption.In experimental models Angiotensin Converting Enzyme (ACE)-inhibitor therapy targeting the over-expression of angiotensin type 1 (AT1) receptors, that are responsible for dysregulated proliferation of parietal cell progenitors, blocks the formation of crescents and their fibrotic evolution. Should these drugs have similar effects in humans, ACE-inhibitor therapy on top of standard immunosuppression might be instrumental to prevent ESRD and promote renal function recovery in clinical practice.


Eligibility Criteria:
Inclusion Criteria:

* Rapidly progressive renal failure associated with acute nephritic syndrome and/or nephrotic syndrome;
* Histology evidence of extracapillary proliferation with less than 50% of sclerotic glomeruli and associated with:

  1. Type I: Anti-Glomerular Basement Membrane (GBM) antibody glomerulonephritis,
  2. Type II: Pauci-immune vasculitis or Anti Neutrophil Cytoplasmic Antibody (ANCA) associated vasculitis;
  3. Type III: Immune-complex mediated glomerular diseases: Proliferative lupus nephritis (LN), IgA nephropathy (IgAN)/ Schönlein-Henoch purpura, Type I membranoproliferative glomerulonephropathy (MPGN), Primary or secondary membranous nephropathy (MN), Primary or idiopathic immune complex glomerulonephritis.
* Clinical indication to immunosuppressive therapy;
* No specific indication to treatment with Renin Angiotensin System (RAS) inhibitors such as heart failure or coronary ischemic disease;
* Written informed consent.

Exclusion Criteria:

* Pre-existing advanced chronic renal failure (creatinine clearance less than 20 ml/min/1.73m2);
* Evidence of B or C virus active infection;
* HIV infection;
* Recent diagnosis of malignancy;
* Prolonged bleeding time and any other contraindication to kidney biopsy evaluation;
* Any specific contraindication to ACE inhibitor therapy (that is: history of angioedema or other treatment-related serious adverse events);
* Pregnancy or lactating;
* Women of childbearing potential without following a scientifically accepted form of contraception;
* Inability to understand the risks and benefit of the study or evidence of an uncooperative attitude;
* Legal incapacity.
AZD9164 Single Ascending Dose Study in Healthy Male Subjects

The aims of the study are to assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of AZD9164 following single ascending dose administrations to healthy male subjects.


Eligibility Criteria:
Inclusion Criteria:

* Provision of signed, written and dated informed consent prior to any study specific procedures
* Have a body mass index (BMI) between 19 and 30 kg/m2 and weigh at least 50 kg and no more than 100 kg
* Be non-smoker or ex-smoker who has stopped smoking (or using other nicotine products) for \>6 months prior to study start

Exclusion Criteria:

* Any clinically significant disease or disorder
* Any clinically significant abnormalities at screening examinations
* Use of any prescribed or non-prescribed medication
Fluids Affecting Bladder Urgency and Lower Urinary Symptoms

This study evaluates whether eliminating certain ingredients (caffeine, alcohol, artificial sweeteners, acidic juices) consumed in beverages reduces bladder symptoms of urinary frequency and urgency. Women with overactive bladder will be recruited. Half of these women will receive instructions to replace beverages containing these ingredients with beverages such as water or milk. The other half of participants will receive instructions on following the United States Department of Agriculture guidelines on healthy eating.

It is commonly believed that it is better for women's bladders if intake of certain beverages is eliminated. Advice is given to women with frequency/urgency symptoms to avoid coffee or tea, sodas or pop, or any other drinks that contain alcohol, caffeine, artificial sweeteners or high acidic content. Although the investigators do not know the direct cause and effect of consuming beverages with these ingredients, there might be reduction in "irritating" sensation to toilet often because of urgency if the beverages with these ingredients are replaced by "non-irritating" beverages.

Eligibility Criteria:
Inclusion Criteria:

* Female
* Daily intake of at least 16 oz. of potentially irritating beverages, defined as drinks that are caffeinated, artificially sweetened, citric/acidic, or alcoholic beverages
* Daily intake of at least 32 oz. of total beverages
* At least two of the following three qualifications: urinating greater than on average seven times during waking hours on 3-day diary, urinating routinely more than two times at night, answering "yes" to experiencing frequent, strong feelings of urgency to empty the bladder.

Exclusion Criteria:

* Men
* History of diabetes, spinal cord injury, multiple sclerosis, muscular dystrophy, cerebral palsy, dementia or Alzheimer's or stroke
* Currently pregnant or within one year of delivery
* Currently report symptoms of pain with urination or frequent urinary tract infections
* Uses diuretic medications, currently taking medication prescribed for bladder symptoms or have had surgery for incontinence with the last 12 months
The Prevalence and Incidence of DVT in General ICU

Deep venous thrombosis (DVT) represents a major problem in intensive care unit (ICU) patients. Despite the use of recommended pharmacological prophylaxis with low molecular weight heparin (LMWH), the incidence of DVT during ICU stay has been reported between 5 and 15 %. The incidence may vary due to many factors, for example the type of ICU population, the type of protocol of pharmacological prophylaxis and also the type of diagnostic approach. Before formerly planned clinical study targeted to lower DVT incidence by individualizing the dose of LMWH, the investigators decided to evaluate the real DVT incidence in the investigated ICU. The prevalence and incidence will be assessed by ultrasound testing in general ICU patients. on the sample of 200 patients. The investigators hypothesize DVT incidence of 5 %. The compliance to the local DVT prophylaxis protocol will be also evaluated.

Type of the study: Observational prospective cohort study. Hypothesis: Despite appropriate prophylaxis of deep venous thrombosis in general ICU patients in accordance with the current guidelines, the incidence of deep venous thrombosis is 5 - 10%.

Sample size: 200 consecutive general ICU patients. Inclusion and exclusion criteria: defined in the Eligibility section. Protocol description: All patients admitted to ICU with expected period of the stay longer than 72 hours will be evaluated for the presence of deep venous thrombosis by ultrasound testing during the first 48 hours of ICU stay. Thereafter, each participant will be examined by ultrasound testing twice a week until the discharge from ICU. All patients will receive deep venous thrombosis prophylaxis following the current guidelines. All patients with positive finding of deep venous thrombosis will be managed in accordance with the current guidelines.

Ultrasound examination for deep venous thrombosis: Ultrasound compression test at the following locations: common femoral vein at the groin, deep femoral vein, popliteal vein, both extremities.

Eligibility Criteria:
All general ICU patients meeting exclusion and inclusion criteria.

Inclusion criteria:

1. General ICU patient with expected length of stay more than 72 hours

Exclusion Criteria:

1. Inability to perform ultrasound investigation for deep venous thrombosis (for medical or technical reasons)
2. ICU stay shorter than 72 hours
Ischemia Driven Enoxaparin Therapy in ACS Presenting as Low Risk (IDEAL)

The purpose of this study is to determine whether enoxaparin (an anticoagulant) is effective in the treatment of patients presenting to the emergency room with chest pain and no electrocardiogram or bloodwork evidence of a heart attack, but with other high risk clinical features

Patients with chest pain and abnormal electrocardiogram or bloodwork (biomarker) indicative of a heart attack benefit from anticoagulant therapy such as enoxaparin. However, even patients without abnormalities on the electrocardiogram or bloodwork are at increased risk for heart attack or death, if they have certain clinical risk factors. It is currently not known whether enoxaparin is also beneficial for these patients.

Comparison: enoxaparin in addition to optimal standard care at the discretion of the treating physician, versus optimal standard care without enoxaparin

Eligibility Criteria:
Inclusion Criteria:

* Male or female (negative pregnancy test required for females of childbearing potential) ≥ 18 years of age and capable of signing informed consent;
* Typical chest discomfort at rest; lasting at least 5 minutes in the prior 24 hours that is highly suggestive of myocardial ischemia and is not explained by trauma or obvious abnormalities on chest x-ray;
* Two or more of high-risk clinical features.

Exclusion Criteria:

* Clear indication for low molecular weight or unfractionated heparin;
* Pregnancy;
* Increased bleeding risk;
* Impaired hemostasis;
* Angina from a secondary cause;
* Inability to commence ST segment monitoring within 4 hours of study drug initiation;
* Uninterpretable ST segment based upon baseline 12-lead ECG;
* Any contraindications to treatment with LMWH (or unfractionated heparin), including heparin induced thrombocytopenia, known allergy to heparin, low molecular weight heparin, pork or pork products;
* Renal insufficiency or renal dialysis;
* A prosthetic heart valve;
* Any other clinically relevant serious diseases;
* Current evidence of inebriation with alcohol or intoxication resulting from other drug abuse;
* Treatment with other investigational agents or devices within the previous 30 days, planned use of investigational drugs or devices, or has previously enrolled in this trial;
* Inability to comply with the protocol;
* Inability to understand the nature, scope, and possible consequences of the study or is otherwise unable to provide informed consent.
Multimodal Drug Infiltration in Total Knee Arthroplasty: Is Posterior Capsular Infiltration Worth the Risk?

Multimodal local anesthetic infiltration (LAI) provides effective pain control in patients undergoing total knee arthroplasty (TKA). Some surgeons avoid posterior capsular infiltration (PCI) for fear of damaging posterior neurovascular structures. Data are limited on the added benefits of PCI using different combinations of local anesthetic agents. Therefore, the investigator wanted to know the effectiveness of pain control in LAI with and without PCI.

Half of participants received LAI with PCI, while the other half received LAI without PCI during total knee arthroplasty.

Analgesic agents were bupivacaine, morphine, ketorolac and epinephrine. All patients received spinal anesthesia and patient controlled analgesia (PCA) for 24 hours post surgery. The surgical technique and postoperative medication protocols were identical in both groups. The visual analogue scale (VAS) for pain during activity and at rest, and morphine consumption were recorded at 6, 12, 18 and 24 hours postoperatively. LAI-related side effects, blood loss, length of hospital stay, and VAS for satisfaction were monitored. The reviewer was blinded to treatment groups.

Eligibility Criteria:
Inclusion Criteria:

* Primary OA of the knee, aged less than 80 years old, and able to understand and comply with the study procedures.

Exclusion Criteria:

* Previous drug dependency
* Inability to undergo a spinal block
* Allergy to study drugs
* Renal insufficiency
* Abnormal liver function
* History of stroke
* History of coronary artery disease
M-TAPA vs Intraperitoneal Bupivacain vs Intraperitoneal Bupivacain +Dexmedetomidin

Laparoscopic cholecystectomy is a common abdominal surgery in Western countries, favored for its minimal invasiveness, leading to less pain, smaller scars, and quicker recovery. Despite its benefits, it is contraindicated in cases of bleeding disorders, peritonitis, hemodynamic instability, severe heart failure, and advanced COPD. Effective postoperative pain management is crucial for faster recovery, shorter hospital stays, and lower costs, using techniques such as intravenous or intramuscular analgesics, epidural analgesia, and local anesthetic injections like TAP block or M-TAPA block. The TAPA block, introduced in 2019, involves applying local anesthetic to the costochondral junction, affecting thoracoabdominal nerves, with a modified version (M- TAPA) applying anesthetic to the lower surface only. Studies have shown M-TAPA's efficacy in reducing pain and analgesic use postoperatively. Postoperative pain from laparoscopic cholecystectomy mainly arises from inflammation in the gallbladder bed and pneumoperitoneum. This study aims to evaluate the postoperative analgesic efficacy of intraperitoneal bupivacaine, bupivacaine with dexmedetomidine, and M-TAPA block by assessing pain scores and analgesic consumption in a prospective, randomized, double- blind trial with 45 patients. Patients will be assigned to three groups: M- TAPA block, intraperitoneal bupivacaine, and intraperitoneal bupivacaine with dexmedetomidine, with an experienced anesthetist administering the blocks and evaluating outcomes to compare these pain management techniques.


Eligibility Criteria:
Inclusion Criteria:

* Laparoscopic cholecystectomy surgery planned
* ASA #-II-III classification
* Willingness to participate in the study

Exclusion Criteria:

* Bleeding disorders
* Signs of infection at the block application site
* Conversion to open surgery
* Allergy to local anesthetics
* Unstable hemodynamics
* Inability to provide informed consent
Breathing and Core Stability Exercise Effects on Lumbopelvic Pain

Lumbopelvic pain refers to self-reported pain in areas of lower region, anterior and posterior pelvic tilt or combination of these. Physical therapy interventions used are breathing exercises with and without core stability exercises. Tool used were Pain Pressure Algometer and Oswestry Disability Index.

Lumbopelvic pain is self-reported pain. It is common complaint for women after labour, and it is found that 25% of newly delivered women experienced low back and pelvic pain. Different interventions have been used to reduce the lumbopelvic pain in general including exercises, drugs, therapies and massage. An increasingly common approach used within physical therapy management are breathing exercises and core stabilization exercises. This study will used to compare the effects of breathing exercises with and without core stability exercise. Pre-assessment will be done using oswestry disability index as subjective measurement and pain pressure algometer as objective measure.

Eligibility Criteria:
Inclusion Criteria:

* Women had parity (2-4) times
* Body mass index that did not exceed 30 Kg/m
* Lumbopelvic pain at least three months until one year postpartum

Exclusion Criteria:

* They were pregnant
* Had systemic inflammatory diseases
* Prolapsed disc
* Neuromuscular disorder
AI-assisted Endoscopy Report System In Improving Reporting Quality

In this study, we proposed a prospective study about the effectiveness of artificial intelligence system for endoscopy report quality in endoscopists. The subjects would be divided into two groups. For the collected endoscopic videos, group A would complete the endoscopy report with the assistance of the artificial intelligence system. The artificial intelligence assistant system can automatically capture images, prompt abnormal lesions and the parts covered by the examination (the upper gastrointestinal tract is divided into 26 parts). Group B would complete the endoscopy report without special prompts. After a period of forgetting, the two groups switched, that is, group A without AI assistance and group B with AI assistance to complete the endoscopy report. Then, the completeness of the report lesion, the accuracy of the lesion location, the completeness of the lesion and the standard part in the captured images, and so on were compared with or without AI assistance.


Eligibility Criteria:
Inclusion Criteria:

1. Males or females who are over 18 years old;
2. After qualified medical education and obtained the Certificate of Chinese medical practitioner;

Exclusion Criteria:

1. Doctors without qualified medical education and didn't obtaine the Certificate of Chinese medical practitioner;
2. The researcher believes that the subjects are not suitable for participating in clinical trials.
A Study to Evaluate the Drug Levels of Deucravacitinib From Tablets After Oral Administration in Healthy Participants

The purpose of this study is to assess the drug levels of deucravacitinib after oral administration in healthy participants.


Eligibility Criteria:
For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit: www.BMSStudyConnect.com

Inclusion Criteria:

* Healthy participants, as determined by no clinically significant deviation from normal in medical history, physical examination, vital signs, 12-lead ECGs, and clinical laboratory determinations.
* Body mass index (BMI) of 18.0 to 32.0 kg/m2, inclusive, and total body weight ≥50 kg (110 lb).
* Willing and able to consume 4 units of alcohol (Part C only). Only participants with low to moderate alcohol consumption will be enrolled in Part C of this study (ie, consumption of between 1 and 21 units per week for males and between 1 and 14 units per week in females).

Exclusion Criteria:

* Current or recent (within 3 months or 90 days of study drug administration) clinically significant gastrointestinal disease that, in the opinion of the investigator or medical monitor, could impact upon the absorption of study drug.
* Any medical condition that presents a potential risk to the participant and/or may compromise the objectives of the study, including a history of or active liver disease.
* Clinically significant history or presence of acute or chronic bacterial, fungal, or viral infection (eg, pneumonia, septicemia) within the 3 months or 90 days prior to screening.

Other protocol-defined inclusion/exclusion criteria apply
En Bloc TURBT With Collins Loop vs Conventional TURBT

This is a prospective, randomized, randomized and single-blind study in patients diagnosed with primary bladder CV. Patients diagnosed by cystoscopy of a bladder tumor and with indication for endoscopic surgical treatment, who meet the inclusion criteria, and who sign the Informed Consent (IC), will be randomized.

The main objective of the study is to assess the quality of the resection, defined as the presence of detrusor muscle in the resected tissue.

The secondary objetives are:

* Compare the surgical time, hospital stay, urinary catheterization time and incidence of complications.
* Compare tumor recurrence after one year of follow up.
* Determine the number of re-TURB as a consequence of the absence of muscle layer in the sample or artifacts (Tx)
* Establish the incidence of conversions as a consequence of difficulties in the technique or intraoperative bleeding.
* Compare the degree of satisfaction of the surgeon

Eligibility Criteria:
Inclusion Criteria:

* \>18 years old.
* Polypoid / sessile primary tumor.
* \< 3 tumors
* Tumor size 10 - 30 mm.

Exclusion Criteria:

* \> 4 tumors
* Size of the largest tumor \<1 cm and\> 4 cm.
* Tumor located in the bladder dome.
* No visualization of the ureteral meatus.
* Flat or in situ tumor.
* Non-urothelial tumors.
* Clotting disorder or treatment with oral anticoagulants.
Phase I Clinical Trial of Diphtheria, Tetanus and Acellular Pertussis (Three Components) Combined Vaccine, Adsorbed .

Pertussis, diphtheria and tetanus are seriously infectious diseases in children. Since using of the vaccine targeted the three components, it greatly reduced incidence of the three kinds of diseases. The Purpose of this study is to preliminary evaluate the safety of DTcP compared to adsorbed diphtheria and tetanus combined vaccine （DT），Diphtheria-tetanus-acellular pertussis vaccine（DTaP） or PENTAXIM（DTaP-IPV-Hib） in participants.

Study participants will receive a single booster dose of DTcP or a single booster dose of local DT in 4 to 6 years old ,a singel booster dose of DTcP or a single booster dose of DTaP in 18 to 24 months, three basic doses of DTcP or three doses of DTaP/ DTaP-IPV-Hib in 2 to 6 months.Safety profile will be assessed in all subjects up to Day 30 post vaccination.

Eligibility Criteria:
Inclusion Criteria:

* Healthy subjects aged 2months、3months、18-24months and 4-6 years old;
* Willing to provide proof of identity;
* Able to understand and sign the informed consent by guardians or trustees;
* Able and willing comply with the requirements of the protocol by guardians or trustees;
* Subjects of 2 months age have not been vaccinated with diphtheria, IPV, Hib, or 13-valent pneumococcal polysaccharide conjugate vaccine;
* Subjects of 3 months have not been inoculated with vaccines containing diphtheria, Hib, 13-valent pneumococcal polysaccharide conjugate vaccine and Meningococcal Group AC Bivalent Meningococcal Conjugate Vaccine;volunteers of 3 months (C3 group) have not been inoculated with vaccines containing IPV;
* Subjects aged 18-24 months who had completed the immunization program of 3 doses of DTaP and had without the fourth DTaP vaccine ;
* Subjects aged 4-6 years who have completed the immunization program of 4 doses of DTaP or similar vaccines containing DTP component, but who have not received DT vaccine;

Exclusion Criteria:

* Premature birth in infant under 1 year of age (delivery before the 37th week of pregnancy)or low birth weight (birth weight\< 2300g for girls,\<2500g for boys);
* History of abnormal labor process or asphyxia rescue ;
* Subjects who has a medical history of diphtheria, pertussis or tetanus;
* In the past 30 days, individuals who have had contact with individuals with confirmed pertussis, diphtheria and tetanus diseases in their families;
* Allergic person;
* Any prior administration of blood products in last 3 month;
* Any prior administration of other research medicines in last 1 month;
* Plans to participate in or is participating in any other drug clinical study;
* Any prior administration of attenuated live vaccine in last 14 days;
* Any prior administration of subunit or inactivated vaccines in last 7 days;
* Had fever before vaccination, Subjects with temperature \>37.0°C on axillary setting;
* According to the investigator's judgment, the subjects have any other factors that make them unfit to participate in the clinical trial
AK104 Combined With Chemotherapy as Neoadjuvant Treatment for Advanced Ovarian Cancer

Previous studies have suggested that immunotherapy combined with chemotherapy as neoadjuvant treatment for ovarian cancer may have a synergistic effect and a manageable safety profile.

AK104 is a bispecific antibody targeting PD-1 and CTLA-4. Therefore, this study aimed to evaluate the efficacy and safety of AK104 combined with chemotherapy as the neoadjuvant treatment for advanced ovarian cancer.


Eligibility Criteria:
Key Inclusion Criteria:

- 1. Woman ≥ 18 and ≤ 75 years old on day of signing informed consent. 2. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1. 3. Advanced FIGO stage III to IV patient not able to receive primary debulking surgery for which neo adjuvant chemotherapy is recommended.

4. Have at least one measurable lesion per RECIST 1.1 assessed by investigator. 5. Have adequate organ function.

Key Exclusion Criteria:

* 1. Histological diagnosis of malignant tumor of non-epithelial origin of the ovary, the fallopian tube or peritoneum or borderline tumor of the ovary.

  2. Patients with other active malignancies within 5 years prior to enrollment. 3. Known active autoimmune diseases. 4. Use of immunosuppressive agents within 14 days prior to the first dose of study treatment.

  5. Presence of other uncontrolled serious medical conditions.