cyrilzakka/clinical-trials huggingface dataset:
A Long-term Study of STAR-0215 in Participants With Hereditary Angioedema

The goal of this trial is to enable the collection of information about long-term safety and clinical activity of STAR-0215 in participants with hereditary angioedema (HAE). Participants will receive repeat doses of STAR-0215 for up to 5 years.


Eligibility Criteria:
Inclusion Criteria:

* Open to participants from STAR-0215-201 (NCT05695248) who have met one of the following conditions:

  * Completed STAR-0215-201 (follow up through 6 months after their last dose);
  * Eligible for STAR-0215-201 and entered the Run-In period but did not qualify for the Treatment Period because they did not meet the criterion for the minimum number of HAE attacks;
  * Eligible for STAR-0215-201 and entered the Run-In period but did not complete it for reasons other than not meeting the criterion for the minimum number of HAE attacks (eligibility requires consultation with the Medical Monitor); or
  * Discontinued STAR-0215-201 (for reasons other than safety) after having completed at least 84 days of trial follow-up since their last dose of STAR-0215 (eligibility requires consultation with the Medical Monitor).
* Open to participants who are STAR-0215 naïve and were not enrolled in STAR-0215-201 (NCT05695248), have a documented diagnosis of HAE (Type 1 or Type 2).

Exclusion Criteria:

* Any concomitant diagnosis of another form of chronic angioedema, such as acquired C1 inhibitor deficiency, HAE with normal C1-esterase inhibitor protein (also known as HAE Type III), idiopathic angioedema, or angioedema associated with urticaria.
* Any exposure to angiotensin-converting enzyme inhibitors or any estrogen-containing medications with systemic absorption (such as hormonal contraceptives or hormone replacement therapy) within 28 days prior to Screening
* Any exposure to androgens (for example, stanozolol, danazol, oxandrolone, methyltestosterone, testosterone) within 7 days prior to Screening.
* Use of therapies prescribed for the prevention of HAE attacks prior to Screening:

  * lanadelumab within 90 days
  * berotralstat within 21 days
  * all other prophylactic therapies, discuss with the Medical Monitor

Note: Other inclusion and exclusion criteria may apply.
Study of Alfimeprase's Ability to Dissolve Blood Clots in the Leg and Help Prevent the Need for Surgery

The purpose of this study is to directly compare the safety and efficacy of intra-thrombus alfimeprase 0.3 mg/kg with placebo in acute peripheral arterial occlusion (PAO) as measured by a 30 day open vascular free surgery rate.

There is an unmet medical need to improve thrombolytic therapy in acute peripheral arterial occlusion (PAO). Currently used plasminogen activators can result in increased circulating levels of plasmin that result in a systemic "lytic state" that does not distinguish between physiologic and pathologic thrombosis. In general, mean plasminogen activator infusion durations of greater than 24 hours in order to achieve successful thrombolysis are problematic in a disease where delayed restoration of arterial flow can lead to irreversible ischemic damage. A direct thrombolytic agent like alfimeprase, with a rapid mechanism of action and a potentially safer bleeding risk profile, could facilitate a rapid restoration of arterial flow and avoidance of open vascular surgery.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 or older
* Arteriographically confirmed acute PAO of the lower extremity with onset of symptoms within 14 days prior to randomization
* Acute index limb ischemia classified as SVS/ISCVS Class I or IIa caused by occlusion of a native artery and/or bypass graft (vein or prosthetic). Only Class I subjects with abrupt onset of ischemic rest pain or abrupt onset/progression of lifestyle-limiting claudication are eligible
* Acute PAO with a need for urgent surgical intervention to restore arterial blood flow in the event of unsuccessful thrombolytic therapy
* Available for follow-up assessments

Exclusion Criteria:

* Contraindication to systemic anticoagulation
* History of endovascular procedure or open vascular surgery on the index limb within the past 30 days
* History of significant acute or chronic kidney disease that would preclude contrast angiography
* Known allergy to contrast agents
* History of heparin induced thrombocytopenia
* Participation in any study of an investigational device, medication, biologic, or other agent within 30 days prior to randomization
* Any thrombolytic therapy within 5 days prior to randomization
* Past participation in any alfimeprase trial
* Pregnant, lactating, or actively menstruating women or women of childbearing potential who are not using adequate contraceptive precautions
* Investigator inability to advance guidewire through index occlusion
* Any other subject feature that in the opinion of the investigator should preclude study participation
The mCRC Patients With pMMR/MSS or dMMR/MSI-H Status Received Palliative Chemotherapy Efficacy and Survival

Deficient mismatch repair (dMMR) or microsatellite instability high (MSI-H) accounts for 4-5% in metastatic colorectal cancer (mCRC). The efficacy and survival of patients with dMMR/MSI-H status received palliative chemotherapy have not clear yet. In this study, the investigators observed the efficacy and survival of dMMR/MSI-H status mCRC patients received palliative first-line chemotherapy.

Colorectal cancer (CRC) is the one of most common cancer in the world. Loss of function of DNA mismatch repair (MMR) is an important mechanism of CRC development. Mutation or modification of MMR genes result in MMR protein deficient (dMMR) and microsatellite instability (MSI). It has been reported that the dMMR or MSI high (MSI-H) phenotype is present in approximately 15-18% of CRC patients. Most dMMR/MSI-H tumors are sporadic CRC, and only approximately 3% of dMMR/MSI-H tumors are Lynch syndrome (LS) or hereditary nonpolyposis colorectal carcinoma (HNPCC).

The dMMR/MSI-H status was reported to be a predictive marker for adjuvant chemotherapy. Multiple retrospective studies showed that dMMR/MSI-H is correlated with a favorable prognosis in stage II/III CRC. Previous studies suggested that dMMR/MSI status may be a predictive marker of decreased benefit form adjuvant monotherapy of 5-fluorouracil (5-FU) in patients with stage II disease, but not in those with stage III disease. For metastatic colorectal cancer (mCRC), the relationship of the MMR/MSI phenotype and prognosis is unclear. Some researchers found that CRC patients with the dMMR/MSI-H phenotype have a worse prognosis. But other researchers thought the dMMR/MSI-H phenotype is no associate to efficacy and survival of palliative chemotherapy, even is benefit for efficacy and survival.Therefore, the aim of this study was to clarify whether the status of dMMR/MSI-H affected progression-free survival (PFS) in mCRC patients who received first-line palliative chemotherapy.

Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 18 years old
2. Histologically confirmed Metastatic colorectal adenocarcinoma;
3. Immunohistochemistry confirmed mismatch repair status or polymerase chain reaction (pCR) / next-generation sequencing (NGS) confirmed microsatellite status
4. Received palliative chemotherapy and have complete information of treatment

Exclusion Criteria:

1. Patients have not tested for mismatch repair or microsatellite
2. Patients have not received palliative chemotherapy or received palliative chemotherapy but treatment information incomplete
A Study to Assess the Efficacy and Safety of ASKP1240 in de Novo Kidney Transplant Recipients

The purpose of this study is to evaluate the efficacy and safety of ASKP1240, an anti-CD40 monoclonal antibody, for the prophylaxis of organ rejection after kidney transplantation. This study will compare the efficacy of basiliximab induction, ASKP1240, mycophenolate mofetil (MMF), and steroids \[calcineurin inhibitor (CNI) avoidance\] to the standard of care immunosuppressive regimen (basiliximab induction + tacrolimus + MMF + steroids). In addition, the study will compare the efficacy of basiliximab induction, ASKP1240, tacrolimus and steroids \[CNI minimization-MMF avoidance\] to the standard of care immunosuppressive regimen (basiliximab induction + tacrolimus + MMF + steroids).

Subjects will be followed for 6 months. Upon completion of the first 6 months of the study, subjects may participate in the Long Term Extension period of the study. Subjects will remain on their original treatment arm up to three years post-transplant (and / or Sponsor discontinues development or the subject no longer wishes to participate in the study).

Eligibility Criteria:
Inclusion Criteria:

* Subject is a recipient of a de novo kidney from a living or deceased donor

Exclusion Criteria:

* Subject has induction therapy, other than study-assigned basiliximab, planned as part of initial immunosuppressive regimen
* Subject has previously received or is receiving an organ transplant other than a kidney
* Subject will receive a solitary kidney from a deceased donor \< 5 years of age
* Subject will receive a kidney with an anticipated cold ischemia time (CIT) of \> 30 hours
* Subject will receive a kidney that meets both Extended Criteria Donor (ECD) and Donation after Cardiac Death (DCD) criteria. Note: a kidney that meets either ECD or DCD criteria is eligible for inclusion
* Subject will receive an ABO incompatible donor kidney
* Subject has a current calculated panel reactive antibody (cPRA) level \>50%
A Dose Ranging Study of OPT-302 With Aflibercept for Persistent Diabetic Macular Edema

A two part, multi-center study consisting of a Phase 1b open label, sequential dose escalation followed by a Phase 2a randomized, double-masked, dose expansion evaluating OPT-302 in combination with aflibercept in participants with persistent central-involved Diabetic Macular Edema.

Study OPT-302-1003 was designed as a 2-part, multicenter study consisting of a Phase 1b open-label, sequential dose escalation followed by a Phase 2a randomized, parallel-group, sham-controlled, double-masked, dose-expansion evaluating intravitreal OPT-302 in combination with aflibercept in participants with persistent central-involved diabetic macula edema.

Eligibility Criteria:
Inclusion Criteria:

* History of diabetic macular edema (DME) ≤ 2 year
* Persistent DME despite prior intravitreal anti-VEGF-A therapy with a sub-optimal response
* Three or more prior anti-VEGF-A therapy intravitreal injections
* EDTRS BCVA score ≤ 73 and ≥ 24 letters

Exclusion Criteria:

* Ocular disorders or ocular treatments which may interfere with assessment of visual acuity, assessment of toxicity, or fundus photography in the Study Eye
* HbA1c ≥ 12% and/or recent signs of uncontrolled diabetes
* Any clinically significant disorder or condition or disease (e.g. cardiovascular, renal conditions) that would make the participant unsuitable for the study
Lung Recruitment in Laparoscpic Surgery

The goal of this clinical trial study is to assess the effectiveness of different methods of lung recruitment maneuver on the incidence of atelectasis in adults undergoing laparoscopic cholecystectomy surgery using lung ultrasound Participants will be divided into three groups as: Control group, sustained inflation group (SI) and Stepwise Positive end expiratory pressure increasing group(Third group). Each contains 31 patients.

Control Group = Keep parameters all through the procedure without any changing GROUP(SI) = After abdominal deflation, we will apply sustained inflation by adjusting Adjustible pressure Limiting valve 40 centimetres water on spontaneous mode, holding the bag for 30 second.

Third group = After abdominal deflation, we will apply stepwise Positive Pressure increasing by 2 centimetres water every 5 breathing cycles till reaching 12 centimetres water and keeping it till extubation, with a maximum airway pressure not exceeding 40 centimetres water.

the effectiveness of different methods of lung recruitment maneuver on the incidence of atelectasis in adults undergoing laparoscopic cholecystectomy surgery using lung ultrasound Participants will be divided into three groups as: Control group, sustained inflation group (SI) and Stepwise POSITIVE pressure increasing group. Each contains 31 patients.

Control Group = Keep parameters all through the procedure without any changing GROUP(SI) = After abdominal deflation, The investigators will apply sustained inflation by adjusting Adjustible pressure valve 40 centimetres water spontaneous mode, holding the bag for 30 second.

Third group = After abdominal deflation, the investigators will apply stepwise POSITIVE pressure increasing by 2 centimeters water 5 breathing cycles till reaching 12 centimetres water and keeping it till extubation, with a maximum airway pressure not exceeding 40 centimetreswater.

During the entire procedure the transducer head will be placed over one point of the chest selected by the operator where the area of atelectasis was detected The probe will be placed in the atelectasis area.

Eligibility Criteria:
Inclusion Criteria:

* Patients with healthy lungs

  * Age between 18 and 65 years old
  * Body mass index (BMI) \<30 kg / m2
  * Physical status I-II of the American Society of Anesthesiologists (ASA)
  * Elective laparoscopic cholecystectomy.

Exclusion Criteria:

* Patient refusal
* Patients with preoperative ultrasound evidence of pulmonary atelectasis.
* Patients who will have conversion from laparoscopic to open surgery.
* Patients experiencing critical postoperative complications such as severe subcutaneous emphysema and pneumothorax.
* Patients with pulmonary, cardiac, and neuromuscular diseases and a corresponding surgical history and respiratory tract infections.
Use of Nutrigenomic Models for the Personalized Treatment With Medical Foods in Obese People

The NutriGen project will be using nutrigenomic methods to determine the effectiveness of treatments with specific dietary foods, on the basis of genetic risk predisposition (genetic signature) of obese individuals.

NutriGen project specific aim 1. Establishing a genetic signature model, involved in the donation of methyl groups and unsaturated omega-6/3 fatty acids metabolism, with a high predictive value for classification of dyslipidemia and insulin resistance in obese subjects.

1. Establishing a genetic signature model in obese adults with dyslipidemia.
2. Establishing a genetic signature model in obese children with insulin resistance. c. Establishing a correlation between blood/plasma concentrations of the relevant metabolites, genetic signatures and dyslipidemia profile of adults, and respectively a profile for insulin resistance in obese children.

NutriGen project specific aim 2. Determining the efficacy of a dietary food specific treatment, which is also correlated with a genetic signature (nutrigenomics), based on the correlations defined in objective 1:

1. Implementation of a treatment with dietary foods (for adults), in the presence/absence of other already prescribed treatments;
2. Implementation of a treatment with dietary foods (for children), in the presence/absence of other already prescribed treatments.

Eligibility Criteria:
Inclusion Criteria:

* Adults: between 18 and 70 years old; obesity present as defined by body mass index (BMI) ≥30 kg/m2 and by abdominal circumference ≥84 cm (women), and ≥90 cm (men); dyslipidemia present as defined by: serum Cholesterol ≥200 mg/dl, HDLc ≤50 mg/dl (women) or ≤40 mg/dl (men), serum Triglycerides ≥150 mg/dl, or present treatment for dyslipidemia (e.g. statins, fibrates, omega-3 fatty acids, cholestyramine, ezetimibe).
* Children: age between 7 and 18 years old; BMI \>+2SD WHO reference

Exclusion Criteria:

* Adults: diagnosed for any type of cancer, or medical history of cancer; any auto-immune disease; any psychiatric disorder; blood coagulation disorders; history of drug abuse; alcohol abuse evaluated using AUDIT-C.
* Children: the above exclusion criteria for adults; familial hypercholesterolemia; endocrine-induced obesity (Cushing syndrome, hypothyroidism, growth hormone deficit), hypothalamus-induced obesity (Babinski-Fröhlich syndrome), genetic syndromes (Prader-Willi, achondroplasia, Bardet-Biedl, Fanconi, Turner, etc.); deposition diseases (glycogenosis, lipomatosis); personal history for: convulsive disorders, nephrotic syndrome, or asthma that necessitated corticoid treatment.
Blood Tuberculosis DNA Levels to Monitor Tuberculosis Treatment

Tuberculosis (TB) is a leading infectious cause of death worldwide. Current strategies for monitoring TB treatment response are culture dependent and insensitive. New methods of assessing treatment response in vivo could inform new drug development and other treatment strategies. Cell-free DNA (cfDNA) - small circulating fragments of DNA - is widely used in maternofetal medicine and oncology for diagnosis and assessment of treatment response. This study aims to investigate whether pathogen derived Mycobacterium tuberculosis-specific cfDNA (Mtb-cfDNA) can be used to monitor TB treatment response.

This feasibility study will take place at Mae RaMat TB Center in Thailand and includes two study groups:

1. Assay Development and Validation
2. Longitudinal Assessment of Mtb-cfDNA levels

This study is funded by the Wellcome Trust; grant reference number: 223099/Z/21/Z

Eligibility Criteria:
Inclusion Criteria:

Participants with a new diagnosis of tuberculosis

* Aged ≥ 18 years old
* Newly microbiologically confirmed (culture or nucleic acid amplification test) diagnosis of Mycobacterium tuberculosis (Mtb.) infection (of any site)
* Has not yet commenced antituberculosis therapy
* Able to understand study procedures and requirements and is able to give informed consent

For healthy volunteers:

* Aged ≥ 18 years old
* Healthy as judged by a responsible physician
* Able to understand study procedures and requirements and is able to give informed consent

Exclusion Criteria:

Participants with a new diagnosis of tuberculosis

* Exposure to antituberculosis treatment in the last 8 weeks (or Mycobacterium tuberculosis (Mtb.) active fluoroquinolone)
* Known history of underlying malignancy
* Pregnancy
* Transfusion dependent anaemia

For healthy volunteers:

* History of tuberculosis infection or latent tuberculosis infection
* Household, or other close contact, of a person living with tuberculosis disease
* Chest radiograph (CXR) changes suggestive of pulmonary tuberculosis
* Presence of symptoms which would otherwise indicate screening for tuberculosis (cough \> 2 weeks duration, fever, weight loss, night sweats)
* Other major medical comorbidity
* Pregnancy
* Known malignancy
Predicting Epileptogenic Tubers in Patients with Tuberous Sclerosis Complex

Accurate localization of epileptogenic tubers (ETs) in patients with tuberous sclerosis complex (TSC) is essential but challenging because ETs lack distinct pathological or genetic markers that differentiate them from other cortical tubers. Approximately 60% of patients fail to have their ETs identified through noninvasive preoperative evaluations, highlighting the clinical need for an efficient, noninvasive ET localization method.

Using MRI data from training datasets, we developed a novel noninvasive fusion model that combines a risk model based on lesion network mapping with a prediction model using brain functional connectivity and random forest algorithms. A retrospective analysis was conducted on TSC patients with epilepsy who underwent resective surgery. Tubers were classified as true-ETs, false-ETs, or true non-ETs based on resection locations and postoperative seizure-freedom. The model calculated and ranked the ET probability for each tuber for every patient, and its accuracy was assessed based on postoperative seizure outcomes.


Eligibility Criteria:
Inclusion Criteria:

(1) male or female patients aged ≥6 months; (2) patients meeting the diagnostic criteria for TSC according to Northrup's guidelines;17 (3) patients in whom the clinical evaluation determined that a single surgical target, or hypothesized primary EZ, was identified by a multidisciplinary specialist team at epilepsy centers of Beijing Children's Hospital, PLA General Hospital, or Shenzhen Children's Hospital in China; (4) patients who underwent resective surgery between July 2016 and June 2023, with a 1-year follow-up completed by June 2024; and (5) availability of patients with available preoperative and postoperative MRI T2-Flair imaging.

Exclusion Criteria:

* (1) patients with a history of craniotomy, serious head injury, neuromodulation therapy, or corpus callosotomy before or within one year after the resective surgery; and (2) subjects lacking key clinical or MRI data. This study was approved by the Ethics Commission of Beijing Children's Hospital.
KTP Green Light Prostatectomy Compared With TUR-P in High Risk Patients

The purpose of this study is to compare safety and efficacy of Green Light PVP (Photoselective Vaporization of the Prostate) compared to TUR-P in high risk patients


Eligibility Criteria:
Inclusion Criteria:

* Men with anticoagulant medication undergoing surgery for BPH

Exclusion Criteria:

* Previous prostate surgery
* Carcinoma of the prostate
* Neurogenic bladder
* Bladder carcinoma