cyrilzakka/clinical-trials huggingface dataset:
Intranasal Breast Milk Therapy in HIE

This is an open-label prospective single-center randomized controlled trial to evaluate the effect of intranasal breast milk in hypoxic-ischemic encephalopathic neonates receiving therapeutic hypothermia on long term neurodevelopmental outcome compared to standard care.

Perinatal asphyxia and the resulting hypoxic-ischemic encephalopathy (HIE) are the leading cause of neonatal mortality and long-term neurodevelopmental disabilities. Based on our current knowledge, therapeutic hypothermia is the only therapy that has been proven to reduce central nervous system damage in HIE neonates. Improving neurodevelopmental outcomes of newborns with HIE has been an intense area of research over the past decade.

Breast milk is a complex biological substance that contains a variety of bioactive components including neurotrophic growth factors, cytokines, immunoglobulins, and multipotent stem cells. Studies have shown that exclusive breastfeeding in the early stages of development has a positive impact on cognitive outcomes. Animal studies support that mesenchymal stem cells and neurotrophic substances found in breast milk, when administered intranasally enter the central nervous system and reduce the extent of neurological damage. In preterm infants, it has been shown that intranasally administered breast milk is safe and well-tolerated.

In this open-label prospective randomized controlled single-center interventional study, the objective is to administer fresh, own-mother's breast milk intranasally to neonates with hypoxic-ischemic encephalopathy receiving therapeutic hypothermia, starting from the first day of life and continuing for 28 days.

The primary objective is to compare neurodevelopmental outcomes between the control group and the intervention group receiving intranasal breast milk treatment. The secondary objective is to compare the progression of enteral feeding and the duration of exclusive breastfeeding between the intervention and the control group.

Eligibility Criteria:
Inclusion Criteria:

* Moderate or severe hypoxic- ischemic encephalopathy, receiving therapeutic hypothermia

  ≥ 35. gestational week \< 48 hours of life
* Hypothermia treatment for 72 hours
* Parental consent form

Exclusion Criteria:

* Congenital malformation
* Concurrent cerebral lesions
* ECMO therapy
* Contraindication of lactation
* Mother unable or unwilling to provide fresh breast milk
* Postpartum asphyxia
Prebiotics and the Management of Hyperuricemia

Hyperuricemia is a major risk factor for many chronic diesease. Recently, gut mcirobiota has been identified as a novel theraputic target for hyperuricemia. Both annimal studies and pilot human trials have demonstrated that administration of prebiotics help delay the progression of hyperuricemia throuh several mechanisms. This trial aims to examine its protective effects and potential mechanisms in clinical trials.

Hyperuricemia is a major risk factor for many chronic diseases. Recently, dysbiosis of gut microbiota has been reported to play an important role in the pathogenesis of hyperuricemia. Animal studies have demonstrated that administration of prebiotics help delay the progression of hyperuricemia through several mechanisms such as reduction in endotoxemia, and enhanced production of short-chain fatty acids and hippuric acid.

However, whether administration of prebiotics also has a protective effect in subjects with hyperuricemia remain under-explored. Moreover, whether the original gut microbiota will influence the protective effect of prebiotics remains largely unknown.

Eligibility Criteria:
Inclusion Criteria:

* Local residents aged between 18-80 years old;

  * Stable weight (\<5% weight change over the past 3 months);
  * Fsating uric acid \> 420 umol/L for male and \> 360 umol/L for female on two different days;
  * Not taking uric acid lowering drugs or have stopped taking uric acid lowering drugs for over 4 weeks at the time of recruitment;
  * Absence of any diet or medication that might interfere with uric acid metabolims or gut microbiota, especially antibiotics, prebiotics or probiotics at the least 4 weeks before recruitment

Exclusion Criteria:

* Acute illness or evidence of any acute or chronic inflammatroy of infective diseases;

  * Participation in regular diet program more than 2 times per week in the lastest 3 months prior to recruitment;
  * Mental illness rendering them unable to understand the nature, scope, and possible consequences of the study;
  * Women of childbearing age who are pregant, breast-feeding or preparing for pregnancy; patients who had surgey within the past 6 months or planned surgery during the trial period.
Goserline Acetate VS Dienogest in Endometriosi

clinical trial aims to evaluate efficacy of dienogest (DNG) in comparison to goserline acetate in complete 12 week treatment of pain in women suffer from chronic pelvic pain diagnosed as endometriosis by laparoscopy and histopathology.

The study will be a clinical trial study of 12-week trial of GnRH (zoladex 3.75mg) injection once every 4 weeks and Visanne (dienogest 2mg) oral once daily for 12 weeks in patients confirmed endometriosis by laparoscopic surgery.

Pretreatment assessment, the patients will be questioned about their pelvic symptoms (dysmenorrhea, nonmenstrual pelvic pain, and deep dyspareunia) after taking full history and examination , The study will investigate and evaluate possible early, long side effects and efficacy of treatment to controlling the pain.

Eligibility Criteria:
Inclusion Criteria:

* Non pregnant women confirmed to have endometriosis by histopathology and not received any hormonal treatment yet. Also, medical treatment was the proper choice for treatment of each case.

Exclusion Criteria:

* Women suspect pregnancy.
* Breast feeding women.
* Previous use of hormonal agents (progestin less than 6 months, danazol less than 3 month, oral contraceptive pills less than 1 month before screening).
* Women with other gynecological pathology interfere with treatment we will use.
* Using of corticosteroids.
* Family history of osteoporosis.
To Demonstrate the Relative Bioavailability Study of Loratadine 10 mg Tablets

To demonstrate the relative bioavailability study of Loratadine 10 mg tablets.


Eligibility Criteria:
Inclusion Criteria:

* No clinically significant abnormal finding on physical exam, medical history, or clinical laboratory results on screening.

Exclusion Criteria:

* Positive test results for HIV or hepatitis B or C.
* Treatment for drug or alcohol dependence.
Thromboxane Receptor Antagonist to Improve Endothelial Function

This study evaluates whether addition of the thromboxane receptor antagonist to chronic aspirin therapy improves endothelial function and reduces non-platelet thromboxane generation in patients with established cardiovascular disease. Half of participants will receive ifetroban and the other half will receive matching placebo for the 4 week study period.

Thromboxane is a prostaglandin produced in healthy individuals mainly in platelets, where it mediates platelet activation and vasoconstriction via binding to cellular thromboxane-prostanoid (TP) receptors. The cardioprotective effect of aspirin is due to suppression of platelet thromboxane generation and reactivity. Unfortunately 25-50% of patients with cardiovascular disease taking ASA continue to generate thromboxane from non-platelet sources, which significantly increases their risk of atherothrombosis and death. Evidence suggests that oxidative stress is a potent stimulus for thromboxane generation in endothelial cells that involves autocrine/paracrine signaling through the TP receptor. This clinical trial addresses the central hypothesis that vascular endothelial cells under oxidative stress are a major source of non-platelet thromboxane generation in patients with cardiovascular disease and that antagonism of the TP receptor will suppress its formation and improve endothelial function.

Eligibility Criteria:
Inclusion Criteria:

* Males and females 18-80 years of age with established cardiovascular disease
* Take \>=81 mg daily of aspirin as part of their daily medical regimen
* Urine thromboxane B2 metabolites \>1145 pg/mg creatinine on screening.
* Able to provide written consent and comply with protocol-specific procedures.

Exclusion Criteria:

* Chronic oral anticoagulation with a non-vitamin K antagonist.
* Anticipated change or interruption in aspirin therapy during the study period.
* ST segment myocardial infarction within the past 30 days.
* Cardiac surgery within the past 30 days.
* Stage 4-5 renal failure or on renal replacement therapy.
* An ongoing uncontrolled severe inflammatory condition.
* Pregnant,intending to become pregnant or breast feeding.
* Known ifetroban or aspirin sensitivity Inability to perform vascular testing.
* Participation in another investigational drug trial within 30 days of randomization.
A Non-Interventional Interview Study of Phenylketonuria (PKU) Adults

The 165-901 study is designed to identify the appropriate tools for use in future interventional studies on the neurocognitive effects of pegvaliase on adults with PKU.

Clinical studies have suggested that treatment with pegvaliase results in lowering of blood Phenylalanine levels in adults with Phenylketonuria (PKU). Because these individuals often exhibit inattention and mood difficulties, and blood Phe concentration affects cognition and mood, life-long blood Phe control with pegvaliase may improve cognitive abilities and emotional and mental health in patients with PKU. In order to adequately quantify potential pegvaliase treatment impact on cognition and mood, it is necessary to employ clinical outcome assessments (COAs) that are fit for purpose and that comprehensively address concepts important, relevant, and meaningful to PKU patients. This is an observational study to identify symptom, function, and health-related quality of life (HRQoL) concepts of interest (COIs) to patients with PKU and to seek additional patient, observer, and expert input on the appropriateness of concepts of BioMarin's proposed COAs for use in future efficacy trials in PKU.

Eligibility Criteria:
Inclusion Criteria:

Patients eligible to participate in this study must meet all of the following criteria:

1. ≥18 and ≤70 years of age at the time of consent;
2. Clinically-confirmed diagnosis of Phenylketonuria (PKU);
3. Blood Phe test completed within eight weeks prior to screening date or blood Phe test completed within eight weeks post screening date;
4. Able to read, understand, and speak fluently the language(s) of their designated country sufficiently to participate in an interview and/or complete all assessments;
5. Willing and able to participate in a telephone interview lasting approximately 90 minutes;
6. Willing to be audio-recorded during the interview session;
7. Willing and able to provide written informed consent indicating that they understand the purpose and procedures required for the study and are willing to participate.

Exclusion Criteria:

Patients meeting any of the following criteria will not be included in the study:

1. Currently pregnant;
2. Current or previous exposure to pegvaliase treatment or participation in a pegvaliase clinical trial;
3. Has a significant cognitive impairment, hearing difficulty, visual impairment, acute psychopathology, medical condition, or insufficient knowledge of the interview language that, in the opinion of the investigator or interviewer, would interfere with his or her ability to provide written consent and participate/complete an interview.
Comparative Accuracy of Three Versions of Non-Invasive Hemoglobin Monitoring

There is no study hypothesis. The purpose of this study is to compare the accuracy of the: 1) SpHb (Radical 7 Pulse Co-Oximetry with SpHb™) RevF sensor (currently marketed), 2) the SpHb RevG sensor (a new, limited release version), and 3) the Pronto-7 sensor (currently marketed version) in patients undergoing spine surgery.

The purpose of this study is to compare the accuracy of the: 1) SpHb RevF sensor (currently marketed), 2) the SpHb RevG sensor (a new, limited release version), and 3) the Pronto-7 sensor (currently marketed version) in patients undergoing spine surgery. The results from the three sensors will be compared to a blood hemoglobin level taken intermittently (as a function of the patient's anesthesia care) and analyzed in the UCSF Clinical Laboratories.

This is an observational study.

Eligibility Criteria:
Inclusion Criteria:

* ≥ 18 years of age
* ASA Classification 1, 2 or 3
* Scheduled to undergo spine surgery

Exclusion Criteria:

* Pregnant of nursing
* In the investigator's judgement would not be suitable for research
Telehealth in Lewy Body Dementia

Lewy body dementia (LBD) is the 2nd most common neurodegenerative dementia in the US. Optimal care requires an interdisciplinary approach, however often faced barriers include rural residence, limited access to specialists, travel distance, limited awareness of resources, and physical, cognitive, and behavioral impairments making travel to appointments challenging. Delivering interdisciplinary care remotely using video technology has the potential to improve access to care for patients with LBD.

The purpose of this study is to convert an in-person patient-centric interdisciplinary care model to a virtual platform using stakeholder engagement from individuals with LBD, their caregivers and healthcare providers. Subsequently researchers will conduct a prospective, randomized, controlled pilot study implementing the virtual stakeholder developed interdisciplinary care model (tele-neurohub) for 6 month and assess the implementation outcomes of feasibility, acceptability, and appropriateness of the tele-neurohub model. The research goal is to establish and iteratively improve a virtual interdisciplinary model of care allowing patients with LBD and their caregivers to access sub-specialty care from their home.

Eligibility Criteria:
Participant with Lewy Body Dementia (LBD) Inclusion Criteria:

* LBD diagnosis by a dementia or movement disorders specialist
* Clinician-determined mild-moderate dementia severity
* Internet access with a Zoom-compatible device
* Caregiver who resides in the patient's home and is willing to participate
* Fluency in English
Effect of Catheter Type on Efficacy of Percutaneous Caudal Adhesolysis

The approach toward FBSS involves conservative management that consists of physical therapy and medication which aims to optimize gait and posture and can improve muscle strength and physical function

The international association for the study of pain has defined failed back syndrome as persistent pain despite spine surgery in the same topographical area.

Several causes have been introduced for FBSS including pressure on the nerve root due to disc re-herniation or retained disc fragment, epidural fibrosis, acquired stenosis, and segmental instability.

Thus, FBSS is a syndrome with diverse etiologies and noticeable heterogeneity among patients. However, about 20% to 36% of FBSS occur due to epidural fibrosis, which is a progressive disease.

The approach toward FBSS involves conservative management that consists of physical therapy and medication which aims to optimize gait and posture and can improve muscle strength and physical function. Oral pharmacological treatment of FBSS is multimodal and increasingly controversial. Treatments include antiepileptics, non-steroidal anti-inflammatory drugs, oral steroids, antidepressants, and opioids including injections, and finally surgical options as a last line therapy. Other modalities including minimally invasive procedures like epidural injections, Epidural steroid injections (ESIs) are the most commonly performed procedure in pain clinics around the world. These can be administered primarily by three approaches: transforaminal, interlaminar, or caudally, and are indicated for symptoms of radiculopathy. Also radiofrequency ablation of nerves are often used to provide sustained relief that a diagnostic block or therapeutic injection cannot provide. Successfully targeting the intended nerve is achieved, maximizing the size of the lesion. Spinal cord stimulation (SCS) is a nother treatment modality that has shown tremendous potential in the management of FBSS. Adhesions can theoretically be lysed, thereby improving baseline pain scores and drug delivery of the ESI. Lysis of adhesions typically occurs by delivering hyaluronidase with hypertonic saline into the epidural space. The use of hyaluronidase with steroid may be more effective and have longer duration of effect than either one alone. Finally, surgical revision for FBSS is associated with a high morbidity with corresponding low rates of success.

Percutaneous adhesiolysis (PA), is a minimally invasive technique, that might be useful in the treatment of chronic pain refractory to conservative treatments. The basic idea behind PA is inserting a catheter in the ventral epidural space could directly break up perineural/epidural adhesions, that act as physical barriers to the perineurally deposited drugs but also cause neural irritation predisposing to neural inflammation.

Eligibility Criteria:
Inclusion Criteria:

* previous back surgery of at least 6 months duration.
* age ≥ 18.
* failure of conventional pharmacological management.

Exclusion Criteria:

* cauda equina syndrome.
* pregnant or lactating women.
* anti-coagulant therapy.
Validity of the SHD-LESS Scale After ACL Reconstruction

After anterior cruciate ligament reconstruction (ACL-R), Single Hop for Distance (SHD) performance aids in decision-making, particularly for return-to-sport assessments. However, asymmetrical landing kinematics are common after ACL-R, even with symmetrical performances, and increase the risk of re-injury. To support clinical practice, several qualitative scales have been developed as valid and reliable tools for assessing landing quality. In 2022, Measson et al. adapted the Landing Error Scoring System for use during an SHD task (SHD-LESS scale) and demonstrated its reliability among healthy individuals.

The aim of this study is to test the validity of this scale after ACL-R by evaluating its ability to identify asymmetrical landing and characterize differences between the operated and uninjured limb. The second objective is to assess its association with knee muscle strength, functional status and psychological readiness.


Eligibility Criteria:
Inclusion Criteria:

* Patients aged 18-40, who have undergone a first ACL reconstruction more than 6 months ago and are being followed in a sports medicine care pathway
* Affiliated with a health insurance plan
* Information form: Non-objection to the use of data for research purposes

Exclusion Criteria:

* Previous ligament surgery of the lower limbs prior to ACL reconstruction
* Complex ligament injury (lateral ligaments, posterior cruciate ligament)
* Recent muscle injuries
* History of injury to the uninjured knee
* Pregnant woman
* Inability to perform a muscular assessment
* Postoperative complications (deep vein thrombosis, sepsis, stiffness/arthrofibrosis)
* Neurological history with residual effects or taking medication that affects balance/coordination
Flatbush FHC Proactive Colorectal Cancer Screening and Navigation

The proposed study is a randomized controlled pilot trial designed to assess the effectiveness and acceptability of a proactive screening outreach program on colorectal cancer screening rates on eligible patients in the Flatbush Family Health Center medical practice.

The proposed study is a randomized controlled pilot trial designed to assess the effectiveness and acceptability of a proactive screening outreach program on colorectal cancer screening rates on eligible patients in the Flatbush Family Health Center medical practice, which provides free and subsidized health services to underrepresented minorities. The investigators will randomize patients to the proactive screening outreach arm which will include mailed letters providing patients with information regarding their eligibility for and instructions for performing colorectal cancer screening with FIT testing or colonoscopy. Colorectal cancer screening rates via FIT testing or colonoscopy will be compared in the proactive outreach group and the usual care group. The investigators hypothesize that rates of colorectal cancer screening will improve in underserved populations with the implementation of a proactive approach that incorporates a mailed outreach invitation to screen, followed by active assistance to a colonoscopy completion if preferred or indicated.

Eligibility Criteria:
Inclusion Criteria:

* Receiving medical care at Flatbush FHC
* Due or overdue for CRC screening

Exclusion Criteria:

* Age younger than 45 years old or greater than 75 years old
* Up-to-date with colorectal cancer screening (FIT within 1 year or colonoscopy within 10 years)
* History of colorectal cancer, inflammatory bowel disease or colorectal polyps
* No address or phone number on file
* FIT test ordered within 6 months
ITI Using SCT800 Alone or Combining Daratumumab in Hemophilia A Adolescents and Adults With High Titer Inhibitor

To evaluate the time of response, sustained remission rate, and relapse rate of CD38 monoclonal antibody (Daratumumab) combined with SCT800 (rFVIII) in the treatment of hemophilia A adolescents and adults with high titer inhibitors.

This is a non-randomized controlled trial to compare the outcome of immune tolerance induction therapy usingnon- SCT800 combined with Daratumumab or SCT800 alone in hemophilia A adolescents and adults with high titer inhibitors. Patients will receive Daratumumab combined with SCT800 or SCT800 alone.

Eligibility Criteria:
Inclusion Criteria

1. Moderate or severe hemophilia A;
2. Aged 14-66 years old;
3. Inhibitor positive at 2 consecutive visits;
4. Inhibitor titer \> 10 BU at the screening visit.

Exclusion Criteria:

1. The patient has contraindications to drug ingredients or hamster protein allergy;
2. Suffering from other immune diseases or Using immunosuppressant IS to treat another disease(s);
3. Failed systemic ITI treatment in history;
4. Poor patients compliance;
5. The investigator believes that there are any other reasons that make the patient unsuitable to participate in this study.
Association of Non-alcoholic Fatty Liver Disease and Coronary Artery Disease

This study will evaluate the association of non-alcoholic fatty liver disease and coronary artery disease. All patients presenting for coronary angiogram will receive the following examination:

* Transient Elastography and Controlled Attenuation Parameter using the FibroScan
* blood examination including biochemical markers The results of non-invasive liver steatosis and fibrosis measurement are compared with the results of coronary angiogram concerning the presence or absence of coronary artery disease.


Eligibility Criteria:
Inclusion Criteria:

* Male or female, 18 years and older
* Written consent
* Coronary angiogram planned

Exclusion Criteria:

* Patients with mental diseases
* Pregnancy or lactation
* Ascites