cyrilzakka/clinical-trials huggingface dataset:
Kinetics of Metabolic Cofactors in NAFLD

There is a strong correlation between major adverse health consequences of obesity and development of non-alcoholic fatty liver disease (NAFLD). NAFLD is characterized by abnormal hepatic accumulation of triglycerides and other lipids. It has become a worldwide health problem that accelerates cirrhosis, type 2 diabetes mellitus (T2DM), and especially premature cardiovascular morbidity and mortality.

The plasma level of glutathione (GSH) is typically depleted in individuals with metabolism related disorders. However, cellular GSH levels cannot be increased by supplementing GSH and it must be synthesized within the liver either de novo or by salvation pathway. The level of GSH is not enough to maintain and regulate the thiol redox status of the liver in subjects with high hepatic steatosis at fasting stage due to the depletion of glycine. Glycine can be synthesized via the interconversion of serine. It has been shown that the serine synthesis is downregulated in patients with NAFLD and supplementation of serine has attenuated alcoholic fatty liver by enhancing homocysteine metabolism in mice and rats. Depleted liver glutathione is also restored by the administration of N-acetylcystein as in acetaminophen poising. L-carnitine and nicotinamide that both stimulate the transfer of fatty acids from cytosol to mitochondria have been identified as two additional cofactors that are depleted in patients with NAFLD.

In this study, the kinetics in blood of pivotal metabolic cofactors, serine, L-carnitine, N-acetylcystein and nicotinamide after single and simultaneous dietary supplementation, are measured.

In 10 healthy subjects with BMI \<30 kg/m2 the plasma concentrations of 4 natural compounds (nicotinamide riboside, L-carnitine, L-serine and N-acetylcystein) are measured by ultra-performance liquid chromatography-tandem mass spectrometry (UPLCMSMS) after individual and combined administration, on five consecutive days and at every hour during 9 hours after administration. The study will start at 8:00 every morning and at each time point, blood samples will be collected.

The taste and any potential sensing of the co-factors such as vertigo, nausea, bowel movement will be recorded.

Each participant will receive one oral dose of Day 1: 1 g nicotinamide riboside; Day 2: 3 g L-carnitine; Day 3: 5 g N-acetylcystein; Day 4: 20 g L-serine; Day 5: combined 1 g nicotinamide riboside, 3 g L-carnitine, 5 g N-acetylcystein, and 20 g L-serine

In addition, untargeted metabolomics analysis as well as O-link proteomics analysis we be performed to study effect of the administered cofactors.

Eligibility Criteria:
Inclusion Criteria:

Healthy without any medication, no smokers, no obesity

Exclusion Criteria:

Any known disease, obesity
Effect of Percutaneous Botulinum Toxin A Injection on Natural Course of Upper Lid Retraction in Thyroid Eye Disease

In active phase of thyroid eye disease some patients have obvious upper lid retraction , and sometimes exposure keratopathy .To date there is not any standard treatment for this situation . We are going to compare the natural course of the upper lid retraction with injection of botulinum toxin A injection to upper lid percutaneously.


Eligibility Criteria:
Inclusion Criteria:

* all the patients wiht oper lid retraction in active phase of thyroid ophthalmopathy

Exclusion Criteria:

* patients in non active phase
Feasibility and Safety of Single Port Robot in Colorectal Procedures

The purpose of this study is to evaluate the safety and feasibility of using the Single Port (SP) robot (daVinci, Intuitive Surgical) to perform single port robotic colon surgery and transanal robotic surgery. The hypothesis of the study is that the SP robot will prove a safe effective modality to perform these procedures.

In the colorectal arena, the robotic approach for benign and malignant disease is well established, with a great deal of literature generated regarding the safety and benefits of a colorectal robotic approach for benign and malignant disease. The section of colorectal surgery at the Lankenau Medical Center has been an active and robust contributor to surgical literature on laparoscopic surgery, robotic colorectal surgery, and single port laparoscopic surgery. Its one investigator has been involved in the development of clinical applications to the single port robotic platform where this has been utilized in cadaver work that has been published. Recently, the SP robot has gone through FDA clearance and is now available for clinical utilization. The FDA approval is for urologic surgery. The SP robot will be utilized in the same fashion to perform the same colorectal operations that the investigators have been performing with multiple port placements in the past to accomplish robotic surgery in a single port platform in the colorectal arena. The principal investigator has worked on the SP robot over the past 3 years with extensive cadaver experience to develop its safe application in the colorectal field. This study will entail a collection of demographics, preoperative, perioperative and postoperative outcomes of the patients into a database to follow this, report on the outcomes, and notably answer questions to demonstrate the feasibility and safety of this approach in colorectal patients.

Eligibility Criteria:
Inclusion Criteria:

* All patients being considered for minimally invasive colorectal surgery will be evaluated for participation in the study.

Exclusion Criteria:

* emergency surgery
* inability to offer informed consent
* pregnant patients
Development of a Scoring and Prediction Model for Weaning Success in ARDS Patients Using Ventilation Parameters Combined with Artificial Intelligence and Deep Learning Techniques

This study aims to develop an AI-supported scoring model to optimize the weaning processes of ARDS patients from mechanical ventilation. Retrospective analysis will be conducted on the data of 25,000 patients, focusing on ventilator parameters and hemodynamic variables. The model will be designed to contribute to clinical decision support systems.

The aim of this study is to develop an artificial intelligence and deep learning-supported scoring system using ventilator parameters obtained during the mechanical ventilation process in patients diagnosed with ARDS. This system seeks to predict and optimize the weaning process, facilitating successful liberation from mechanical ventilation.

In this context, our study will analyze data from 25,000 patients obtained from the Metavision system. From this data pool, ARDS patients will be filtered and divided into two groups: those successfully weaned from mechanical ventilation (weaned) and those who were not (non-weaned). The ventilator parameters of both groups, including oxygenation indices, driving pressure, and total mechanical power, will be examined in detail.

The collected data will be analyzed using artificial intelligence and deep learning algorithms to develop a scoring system capable of predicting patients' weaning processes. This system is designed to guide clinicians in patient management and enhance the success of weaning procedures.

The results of this study aim to contribute to more efficient and safer management of the weaning process for ARDS patients. Furthermore, the implementation of AI-supported scoring systems in intensive care units is expected to promote widespread adoption and improve the quality of patient care.

Eligibility Criteria:
Inclusion Criteria:

* ARDS diagnosis
* Aged 18 years and older
* Intubated and followed by Mechanical ventilation
* Admission on Intensive care unit
* Complete data on clinical support and desicion system

Exclusion Criteria:

* Missing data
* Under 18 years of age
* Followed by non-ARDS conditions
* Terminal status
Comparison of Dry Needling and IASTM on Hamstring Tightness in Posterior Pelvic Tilt

The purpose of the study is to compare the effects of dry needling (DN) and instrument-assisted soft tissue mobilization (IASTM) on pain, range of motion, lower extremity functional status on hamstring tightness in patients with posterior pelvic tilt.

A study conducted analyzed the effects of a 3-week combined treatment using transcutaneous electrical nerve stimulation (TENS) and instrument-assisted soft tissue mobilization (IASTM) on chronic back pain. The findings showed that this short-term combined treatment led to reduced pain levels and improved motor function in Chronic low back pain (CLBP) patients. These results suggest that TENS and IASTM could be beneficial as a complementary approach for managing chronic low back pain.

In a randomized trial which shows the results by comparing the efficacy of dry needling (DN) and Graston techniques (GR) in treating upper trapezius myofascial trigger points. Both interventions, were administered twice a week for 2 weeks and when combined with conventional treatment and home exercises, showed significant improvements. However, DN demonstrated superior outcomes in terms of the myofascial diagnostic scale, neck disability index, pain rating, and cervical range of motion. These findings highlight the effectiveness of DN in targeting trigger points and optimizing clinical outcomes.

A notable lacuna persists in the literature concerning the effects of dry needling (DN) and instrument-assisted soft tissue mobilization (IASTM) on patients diagnosed with hamstring tightness and concurrent posterior pelvic tilt. The dearth of comparative research, inadequate incorporation of comprehensive outcome measures, and the paucity of studies targeting this specific patient cohort contribute to this research gap. Addressing this gap would yield valuable insights into the comparative efficacies and outcomes of DN and IASTM pertaining to pain modulation, range of motion enhancement and optimization of lower extremity functional status in this distinct population subset.

Eligibility Criteria:
Inclusion Criteria:

* Lack of greater or equal to 20 degrees of supine active knee extension
* Passive SLR less or equal to 75 degrees
* Atraumatic back or knee pain greater or equal to 2 weeks
* Individuals willing to participate in the required treatment sessions and follow-up assessments
* Posterior pelvic tilt 8.9 standard deviation of 4.5 degree

Exclusion Criteria:

* History of herniated lumbar disc/radiculopathy
* Prior surgery in the hip, knee, or back
* Self-reported pregnancy
* History of blood borne pathogens/infectious disease/active infection
* Metal allergy
* Positive instability tests indicative of ligamentous tear
* Positive meniscal tests
Study of an Approved Drug in Patients With Asthma (0476-289)(COMPLETED)

The purpose of this study is to assess the efficacy and safety of an approved drug on asthma symptoms in patients with chronic asthma which is also active during the allergy season.


Eligibility Criteria:
Inclusion Criteria:

* Asthma symptoms brought on by allergies

Exclusion Criteria:

* Patient has any lung disease
* Currently have a sinus infection or cold symptoms
A Randomized Controlled Trial of an Online Support Group for Sexual Distress Due to Gynecologic Cancer

There is a high prevalence of sexual and body image problems among women treated for gynecologic cancer, which can lead to considerable distress. Given the sensitive and highly personal nature of these problems, women are often reluctant to speak to their doctors about these concerns and have few resources for support and information. The research team will conduct a prospective randomized controlled trail (RCT) to test the benefits of "GyneGals," a 12-week online (i.e. Internet-based) support group intervention for women who are sexually distressed due to gynecologic cancer and its treatment.

The primary aim of this study is to determine whether a professionally-facilitated, information-rich, online support group is beneficial for women who are sexually distressed due to gynecologic cancer and the side effects of treatment.


Eligibility Criteria:
Inclusion Criteria:

* Received surgical, radiation or chemotherapy treatments for any gynecologic cancer
* Not receiving active treatment
* Currently disease-free for a minimum of 3 months
* No more than 5 years post-diagnosis
* Distressed due to psychosexual concerns related to cancer
* Willing to discuss psychosexual concerns
* 18 years or older
* Has access to a computer and the Internet
* Speaks, reads, and writes in English
* Provides informed consent

Exclusion Criteria:

* Acutely suicidal (i.e., actively suicidal within the previous 3 months)
* Has a major psychiatric illness
Safety and Dose Ranging Study of Insulin Receptor MoAb-IDS Fusion Protein in Patients With Hunter Syndrome

AGT-182 is a fusion protein containing idursulfase that is intended to deliver the enzyme peripherally and to the brain, when administered intravenously. This study is a safety and dose ranging study to obtain safety and exposure data, as well as information on the biological activity of the investigational drug.

This is a sequential, open-label, dose escalation, multi-dose study in adults with Hunter syndrome. Two dose levels, assuming tolerability, are planned sequentially, with safety data from the previous cohort being reviewed prior to escalation to the next higher dose cohort. Subjects will receive weekly doses of AGT-182 for 8 weeks if ERT-naive or agreeing to a 6-week ERT washout, or for 13 weeks if currently taking ERT and not agreeing to washout.

Eligibility Criteria:
Inclusion Criteria:

* Male age 18 years or older
* Diagnosis of Hunter Syndrome (documented fibroblast or leukocyte IDS enzyme activity level of less than 10% of the lower limit of the normal range of the measuring laboratory - or any level of enzyme deficiency together with the presence of a pathogenic mutation in the IDS gene - and documentation of normal enzymatic activity of at least 1 other sulfatase.)
* Must fall into one of the following groups:

  * currently receiving standard enzyme replacement therapy (ERT) and be willing to discontinue it for the study duration, taking AGT-182 instead
  * have not received standard ERT for at least 3 months and have elevated uGAGs of at least 3.5 fold above age-related normals at study screening
  * have never received ERT
* Voluntary written consent
* Sexually mature males must be advised to use a medically accepted method of contraception throughout the study.

Exclusion Criteria:

* Refusal to complete screening/baseline evaluations
* Receipt of an investigational drug within the prior 90 days
* Any medical condition or other circumstances that may significantly interfere with study compliance
* Clinically significant spinal cord compression, evidence of cervical instability
* Known hypersensitivity to idursulfase or any of the components of AGT-182
* Known to be nonresponsive to standard ERT treatment (i.e., high uGAG values despite taking full dose standard ERT)
* History of diabetes mellitus or hypoglycemia
* Contraindication to lumbar puncture, if the patient agrees to this optional assessment
The Feasibility of Dexmedetomidine for Awake Fiberoptic Nasal Intubation

The objective of this study is to evaluate the feasibility of dexmedetomidine infusion for oral cancer patients undergoing awake fiberoptic nasal intubation. We hypothesized that a loading dose of intravenous dexmedetomidine before awake fiberoptic nasal intubation for oral cancer patients undergoing general anesthesia will provide adequate sedation and analgesia without respiratory depression and upper airway obstruction.

Case number: 60, ASA I-III oral cancer patients with limited mouth opening

Patients will be randomly allocated into three groups, Dex group received dexmedetomidine (1.0 mcg/kg) infusion, Control group received saline, and Propofol group received 1% Propofol administrated usng effect-site TCI.

Main outcome was evaluated by grading scores presenting conditions for nasal intubation, post-intubation and satisfaction.

Other analysed parameters included airway obstruction, hemodynamic changes, treatment for hemodynamics response, consumption time for intubation, amnesia level, and postoperative adverse events. All outcome measurements were classified by scoring systems.

Eligibility Criteria:
Inclusion Criteria:

* Head and neck cancer patients with limited mouth opening
* Undergoing awake fiberoptic nasal intubation for elective surgery

Exclusion Criteria:

* a history of severe bradycardia
* any type of A-V block in EKG
* heart failure
* liver cirrhosis
* thrombocytopenia
* coagulopathy
A Study of Eribulin-Based Regimen Versus Other Chemotherpy in Triple-Negative Metastatic Breast Cancer (ERI-Based-01).

A Single-Center Retrospective Study About Efficacy and Safety of Eribulin-Based Regimen in the Treatment of Metastatic Triple-Negative Breast Cancer and Comparison With Other Chemotherapy Regimen

Not provided

Eligibility Criteria:
Inclusion Criteria:

1. Women aged 18-70.
2. The pathologic diagnosis of unresectable recurrent or metastatic triple-negative breast cancer ［ER-negative(IHC\<1%), PR-negative(IHC\<1%), HER2-negative（IHC-/+ or IHC++ and FISH/CISH-）］.
3. Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2.
4. Patients with at least one measuring lesion that was conformed to RECIST v1.1 standard.
5. Patients receiving eribulin-based therapy received at least two cycles of eribulin-based chemotherapy. Eribulin was treated until disease progression, unacceptable toxicity or patient refusal of treatment.
6. Adverse events were recorded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE 5.0).

Exclusion Criteria:

1. Patients previously treated with eribulin.
2. Patients with grade ≥3 adverse events did not recover according to CTCAE 5.0 criteria.
3. Not applicable to combined chemotherapy, or allergic or intolerant to related drugs.
Clinical Trial With MSC for Graft Versus Host Disease Treatment

Sequential administration of MSCs obtained from adipose tissue is an effective and safe treatment for acute graft versus host disease refractory to first-line treatment. Furthermore the infusion of these cells produces a biological pattern in patients that relates to the clinical response.

Multicenter, open, non -controlled clinical trial. It is a phase I-II trial to assess the safety and efficacy of sequential infusion of allogeneic MSCs from adipose tissue, expanded "in vitro" platelet lysate in the treatment of patients undergoing hematopoietic stem cell trasplantation, who have developed a refractory graft versus host disease to first line of treatment.

This is a prospective, multicenter, open to patients undergoing allogeneic transplantation in Spanish hospitals, with one cohort of patients who receive four sequential doses of MSC.

Eligibility Criteria:
Inclusion Criteria:

1. Diagnosis of ≥ grade II Graft Versus Host Disease refractory to first-line treatment.
2. Having been subjected to hematopoietic Stem Cell Transplantation as treatment for malignant blood disorder has been controlled by the transplantation. The source may have been bone marrow cells or peripheral blood (PB) and coming from a family member or unrelated donor.
3. Having been transplanted with myeloablative or non-myeloablative conditioning.
4. normal cardiac function (EF ≥ 40%) without evidence of uncontrolled hypertension, congestive heart failure, angina pectoris or myocardial infarction within 6 months prior to the process
5. Lung function without evidence of severe obstructive or restrictive lung disease.
6. Age between 18 and 65 years.
7. Women of childbearing age considered until one year after the last menstrual period and which have not undergone a surgical sterilization must obtain a negative pregnancy test at the time of inclusion in the study and commit to use a medically approved birth control while on study.
8. normal cardiac function (EF ≥ 40%) without evidence of uncontrolled hypertension, congestive heart failure, angina pectoris or myocardial infarction within 6 months prior to the process.
9. Signature of informed consent -

Exclusion Criteria:

1. uncontrolled blood disorder by transplantation or progression at the time of inclusion.
2. bacterial, viral, fungal or is not being controlled.
3. Any circumstance that the proposed trial dissuade medical treatment. Pregnancy, lactation or refusal to use safe contraceptive measures.
4. Patients who are currently participating or have completed their participation in a clinical trial in less than 3 months or who have participated in a clinical trial of Advanced Therapies at any previous time period.
5. Patients who are currently participating or have completed their participation in a clinical trial in a period shorter than 3 months or who have participated in a clinical trial of Advanced Therapies at any previous time.
6. positive serology for Hepatitis B , Hepatitis C and AIDS Virus. -
Follow up Study of Patients Undergoing Total Hip Arthroplasty CERAFIT® Grafted With Poly Sodium Styrene Sulfonate

The risk of infection after primary Total Hip Arthroplasties (THA)is generally estimated to be less than 1% but remains a severe and costly complication, source of morbidity and even mortality. The "biofilm" forms very early after the bacterial contamination of the prosthesis and poses a number of clinical challenges due to his resistance to immune defence mechanisms and antibiotics. Preventive strategies are needed. The poly sodium styrene sulfonate (pNaSS) is a bioactive polymer. In vitro and in vivo studies showed that poly sodium styrene sulfonate grafted on titane surfaces reduce significantly the bacterial adhesion. They also proved his biocompatibility and osseous-integration.


Eligibility Criteria:
Inclusion Criteria:

* Age less than 75 years old
* Aetiologies for THA : primary osteoarthritis, inflammatory diseases,Osteonecrosis

Exclusion Criteria:

* Previous infectious hip arthritis
* Previous surgeries on the operated hip
* Revision of THA
Laparoscopic-assisted Versus Ultrasonography-guided Transversus Abdominis Plane Block in Laparoscopic Sleeve Gastrectomy

The transversus abdominis plane (TAP) block, whereby local anesthetic is injected between the internal oblique and transversus abdominis fascia to facilitate blockade of somatic afferents nerves, is an effective, non-narcotic adjunct incorporated into many ERAS protocols. We hypothesized that surgeon delivered LAP-TAPs would be non-inferior to anesthesia-delivered US-TAPs in terms of post-operative pain control


Eligibility Criteria:
Inclusion Criteria:

Elective laparoscopic sleeve gastrectomy aging \> 18years BMI \> 40 kg/m2, ASA score I-III

Exclusion Criteria:

history of chronic opioid consumption suffering from contraindications to regional blocks suffering from allergy to study drugs, history of prior complex abdominal wall reconstruction