cyrilzakka/clinical-trials huggingface dataset:
Impact of Treatment With VENARUS® on the Level of Monocyte Chemoattractant Protein 1 in Varicose Veins Blood

This study is designed to find if the venoactive drug contained diosmin and hesperidin is able to work against chronic vein-specific inflammation by changing the level of Monocyte Chemoattractant Protein 1. This chemokine is involved in the vein wall remodeling in patients with lower limb varicose veins.

The study is a post-registration open-label observational prospective single-center study with minimal intervention. Individuals aged 18-50 with varicose veins and CEAP C2-C4, Ep, As, Pr will be invited to participate in the study.

Those who agree, will be examined both clinically and by duplex ultrasound. Medical history of participants will be taken, demographic data will be collected. Blood will be drawn from the varicose vein of the affected limb. Discomfort in the affected limb will be evaluated by a visual-analog scale. Duplex ultrasound will be used in every resident to reveal pathological venous reflux in deep and superficial veins.

Eligibility Criteria:
Inclusion Criteria:

* • both female and male

  * age from 18 to 50 years old
  * Verified diagnosis of chronic venous insufficiency CEAP C2-C4
  * signed infromed consent
  * Absence of any other treatment 2 weeks before the start of the study and throughout the duration of the study

Exclusion Criteria:

* • age less than 18 and more than 50 years

  * Previously performed invasive interventions for varicose veins on any of the lower extremities
  * No visible varicose veins
  * Thrombophlebitis and deep vein thrombosis of the lower extremities in the past
  * Taking prohibited pre-trial therapy
  * Contraindications to taking Venarus®
  * not signed informed consent
Efficacy and Safety of Rexlemestrocel-L Combined With HA* in Participants With Moderate to Severe Chronic Low Back Pain

The primary purpose of this study is to evaluate the efficacy of rexlemestrocel-L+HA compared to control in reducing low back pain at 12 months post-treatment and safety of a single injection of rexlemestrocel-L+HA injected into a lumbar intervertebral disc compared to control through 12 months post-treatment.


Eligibility Criteria:
Inclusion Criteria:

* Participants with moderate to severe low back pain for a duration of at least six months who have failed at least 3 months of conservative care.
* Participants who have moderate radiographic degeneration of an intervertebral disc from L1 to S1, with a single disc suspected of causing chronic lower back pain (CLBP).

Exclusion Criteria:

* Participants who have been a recipient of prior allogeneic stem cell/progenitor cell therapy for any indication or autologous stem cell/progenitor cell therapy or other biological intervention to repair the index intervertebral disc.
* Participants with low back pain duration of less than 6 months or greater than 60 months.
* Participants who have not received at least 3 months of conservative treatment for back pain without adequate pain relief.
* Participants taking systemic immunosuppressants.
* Participants with osteoporosis.
* Participants with alcohol or substance abuse problems.
* Participants with severe depression or anxiety.
* Participants with cauda equina syndrome; fibromyalgia, symptomatic central vertebral canal stenosis, lumbar spondylitis or other undifferentiated spondyloarthropathy affecting the index disc.
* Participants having undergone a surgical procedure affecting the structure/biomechanics of the disc (e.g., discectomy, intradiscal electrothermal therapy, intradiscal radiofrequency, artificial disc replacement, interbody fusion, laminectomy, etc.) at the index or adjacent levels.
* Participants who have received any lumbar intradiscal injection into the index disc or adjacent discs within three months prior to the start of screening, other than injection of contrast medium for discography.
* Participants who received an epidural steroid injection within 6 weeks prior to informed consent.
* Participants with evidence of neurologic deficit on any component of the lumbar neurological exam at baseline.
* Participants with sacroiliac (SI) joint pain, as determined by a targeted physical exam, or SI joint injection.
* Participants with facet joint pain, as determined by a medial branch block.
* Participants with more than a single painful level.
* Participants with a full thickness annular tear observed on magnetic resonance imaging (MRI) or discography.
* Participants with low back pain that is less than moderate in severity.
* Participants with extreme low back pain.
* Participants who lack moderate to extreme functional limitations/disability.

Note: Other exclusion criteria may apply.
Alpha-lipoic Acid in Diabetic Nephropathy

Endothelial dysfunction in diabetes is a central event in the pathogenesis of different microangioapthic changes. Nephropathy in patients with type 1 diabetes is a severe microvascular complication.

Better understanding of the pathogenesis of microvascular complications in type 1 diabetes have paved the way for novel therapeutic targets and possible adjuvant therapeutic modalities. Oxidative stress is considered a common and important factor that links hyperglycemia with the vascular complications in diabetes, including of diabetic nephropathy (DN).

Alpha lipoic acid (ALA), or thioctacid, is an antioxidant compound which serve as a cofactor for mitochondrial respiratory enzymes. ALA can scavenge free radicals, activate antioxidant systems, and also affect inflammatory markers. It also has unique characteristic. ALA can play as a reduction for oxidized forms of components with antioxidant properties and neutralize reactive oxygen species. Thus, it called as antioxidant of antioxidants

Eligibility Criteria:
Inclusion Criteria:

* Children and adolescents with type 1 diabetes
* The presence of diabetic nephropathy

Exclusion Criteria:

* Renal impairment due to causes other than diabetes
* Other diabetic complications than nephropathy
* Elevated liver enzymes
* Hypersensitivity to lipoic acid
* Participation in a previous investigational drug study within the 30 days preceding screening
Calls and Coordination for Transitions of Care at Re-entry

The goal of this clinical trial is to learn if a short program for people being released from prison can help connect them to medical care. The main question it aims to answer is:

* Will there be more non-emergency, outpatient clinic visits?

Researchers will compare the number of clinic visits between people who use a Nurse Case Manager (NCM) to people in enhanced usual care.

Participants will:

* Complete surveys
* Talk to a study team member 2-3 times, or talk to a study team member 2-3 times and talk to an NCM 6-11 times

The objective of this clinical trial is to test the effectiveness of a transitional care program adapted to meet the healthcare needs of adults after release from prison. The goal of the transitional care intervention being tested is to help the study participants connect to primary care within 60 days of release through weekly check-in calls. Participants in this study are enrolled approximately 6 months before their anticipated release. One group will receive weekly phone calls for up to 60 days post-release. Additionally, novel, linked administrative datasets will be leveraged to enhance, contextualize, and clarify policy implications of the clinical trial results.

Eligibility Criteria:
Inclusion Criteria:

* age 18 or older
* eligibility for WI Medicaid and intention to enroll before release
* substance use history (i.e., "have you ever considered your alcohol or drug use to be a problem?"), and
* living with, or history of, a chronic medical or psychiatric condition other than substance use disorder. This is defined as ever having been diagnosed with a medical or psychiatric chronic condition, or currently taking prescription medications for a chronic condition.

Exclusion Criteria:

* ineligible for WI Medicaid
* no substance use history
* not living with, or no history of, chronic medical or psychiatric condition
Resilience Models in Adolescence and Youth With Cancer in Taiwan

Validation of Resilience Models about Cancer in Adolescence and Youth in Taiwan

This study uses the disease resilience model as a framework to explore the relationship between physical, mental, spiritual, and social aspects of resilience in adolescents with cancer and to verify the resilience model. It is expected that the research results will serve as a reference for designing nursing interventions in the future and develop local Resilience model to improve quality of care.

Eligibility Criteria:
Inclusion Criteria

* Diagnosed with cancer before 18 years old
* Aged between 10 and 24 years
* Received cancer treatment or completed treatment

Exclusion Criteria:

* Diagnosis of mental problems (developmental delay or psychiatric illness)
* At the end of life
Prevention of Excessive Weight Gain by Discouraging Students From Drinking Sodas

The purpose of this study was to encourage students to reduce soft drinks intake, substituting it by water, in order to prevent and control overweight prevalence.

During seven months of one school year, a healthy lifestyle education programme was implemented using simple messages encouraging water consumption instead of sugar sweetened carbonated beverages. The messages were previously tested for understanding in two small groups of children of the same age and socio-economic background as the study participants. Also, beliefs and behaviors of children in these focus groups were recorded in order to orient activities and the production of printed materials to be given to participants. Education was delivered via classroom activities; banners were hung promoting water consumption, and water bottles with the logo of the campaign were given to children and schoolteachers.

Eligibility Criteria:
Inclusion Criteria:

* 4th grade morning classes

Exclusion Criteria:

* Pregnancy
* Physical disabilities preventing anthropometric measurement
Safety of Terbogrel in Patients With Primary Pulmonary Hypertension

Study to assess the safety of terbogrel during open-label, long-term treatment in medically stable or improving patients with primary pulmonary hypertension who have completed the 12-week, double-blind randomized trial of terbogrel (protocol 528.19)


Eligibility Criteria:
Inclusion Criteria:

Patients who

* completed the preceding primary pulmonary hypertension, double-blinded clinical trial of terbogrel (protocol 528.19)
* provide informed consent to participate in this trial
* are in a stable or improving medical condition, in the opinion of the investigator
* enter the study immediately upon their completion of the preceding double-blind Trial 528.19, or enter the study within one month of completing the preceding trial as long as their medical condition has remained stable or continues to improve in the interim

Exclusion Criteria:

* Development of an unstable medical condition during or following completion of the preceding clinical trial which, in the investigator's opinion, may be worsened by treatment with terbogrel
* Premature discontinuation of the preceding terbogrel clinical trial due to an adverse event or for any other reason
* Pregnant or nursing women, or women of childbearing potential (less than one year postmenopausal or not surgically sterilized) who are not using adequate methods of birth control
Real-world Experience on the Use of Upadacitinib in the Treatment of Moderate-severe Adult Atopic Dermatitis (ERUDA)

Real-world experience on the use of Upadacitinib in the treatment of Adult moderate-severe atopic dermatitis

Atopic dermatitis (DA) is a chronic-recurrent inflammatory skin disease with high prevalence in children. Clinical remission is frequently observed during or after childhood although it may persist and/or recur, even after long and transient remission, in adulthood. In addition, in some patients the DA begins in adulthood: in these cases, we speak of DA adult-onset. In addition to the diagnostic framework, it is also important in clinical practice to assess the severity of the disease on which the choice of treatment is based, which will also take into account other factors such as: possible comorbidities, Previously performed therapies and patient needs. For the management of moderate-severe forms of atopic dermatitis topical drugs, phototherapy, traditional immunomodulating drugs and a biological drug are currently available. Compared to other chronic inflammatory skin diseases the therapeutic paraphernalia should be considered limited, with most systemic drugs that have no indication for the treatment of DA (off-label use).

In the pipeline there are numerous drugs that have reached an advanced stage of development. These include upadacitinib, a new-generation oral drug (small molecule) that selectively inhibits the signal mediated by Janus kinases 1 (JAK-1), has recently received approval for treatment of DA by EMA and AIFA to begin compassionate use of patients deemed contraindicated, intolerant, and/or non-responsive to traditional systemic therapies and biological therapy.

* Evaluation of the effectiveness of upadacitinib using the EASI score Secondary objectives
* Evaluation of the safety profile of upadacitinib
* Predictive factors of treatment response
* Assessment of patient quality of life

Eligibility Criteria:
Inclusion Criteria:

1. Age 18 years
2. Signature of informed consent
3. Diagnosis of moderate and/or severe DA by a dermatologist specialist
4. Approval of the compassionate use of upadacitinib

Exclusion Criteria:

1. Patient unable to give informed consent prior to any collection procedure study data
2. unable to complete the procedures required for the study
Study of Brimonidine and Timolol Ophthalmic Solution With Latanoprost Compared With Latanoprost in Glaucoma Patients

This study will evaluate the safety and efficacy of patients switched from latanoprost monotherapy to a combination therapy of latanoprost with COMBIGAN® (brimonidine 0.2%/timolol 0.5% fixed combination ophthalmic solution) for chronic angle closure glaucoma.


Eligibility Criteria:
Inclusion Criteria:

* Patient has been administering latanoprost eye drops in affected eye(s) for at least 12 weeks prior to study
* Patient must have at least partially responded to latanoprost and requiring further IOP lowering eye drops
* Diagnosis of chronic angle-closure glaucoma
* Patients using COMBIGAN® in the past must not have been discontinued due to adverse events or lack of efficacy.

Exclusion Criteria:

* Known allergy or hypersensitivity to COMBIGAN®
* Corneal abnormalities that would preclude accurate IOP readings
* Any other active ocular disease other than glaucoma or ocular hypertension
* Ocular surgery within the past 3 months.
Quadriceps Strengthening With Patellar Taping in Patellofemoral Pain Syndrome Among Young Adult Male Athletes

This study aims to investigate the effects of electromyography biofeedback (EMG-BF) guided isometric quadriceps strengthening with patellar taping and isometric exercise alone in young adult male athletes with patellofemoral pain syndrome (PFPS).

A total of 60 adult male athletes aged 18 to 45 years will be recruited from two cities (Majmaah and Riyadh) of Saudi Arabia. Subjects will be included with the history of knee pain during activities such as descending and ascending stairs, squatting, and running, had positive J sign (lateral tilt of patella), and a sign of patellar malalignment on the radiograph. Individuals with the history of fracture around knee, patella dislocation, knee deformity (e.g., genu varum), flexion contracture, ligaments/meniscal injuries, and osteoarthritis of knee will be excluded from the study. The protocol was submitted to and approved by the ethical sub-committee of College of applied medical science, Majmaah, Saudi Arabia (Ethics number: MUREC-Nov./COM-2O20/11-2). Participants will be requested to sign a written informed consent form approved by the institution ethics committee.

Participants will be randomly assigned to Group A (experimental group): electromyography biofeedback (EMG-BF) guided maximum voluntary isometric contraction exercise with patellar taping; Group B (control group): sham EMG-BF guided maximum voluntary isometric contraction without patellar taping. The outcome measure for this study will be the mean changes in maximum voluntary isometric contraction (MVIC) of the quadriceps muscle, pain intensity, and functional status up to 6 weeks.

Eligibility Criteria:
Inclusion Criteria:

1. Knee pain during activities such as descending and ascending stairs, squatting, and running,
2. Positive J sign (lateral tilt of patella),
3. Sign of patellar malalignment on radiograph.

Exclusion Criteria:

1. Fracture around knee,
2. Patella dislocation,
3. Knee deformity (e.g., genu varum),
4. Knee flexion contracture,
5. Ligaments/meniscal injuries, and
6. Osteoarthritis of knee.
Photodynamic Therapy for Glioblastoma Multiforme Based on Metaverse and Yellow Fluorescence

GBM patients receiving PDT treatment (50 cases，surgery combined with photodynamic therapy) and traditional treatment (50 cases，traditional surgery) in our hospital and partner hospitals were collected. The prognosis was analyzed by comparing with the control group from multiple perspectives such as image evaluation, imaging effect, Karnofsky score, median survival time and survival rate.


Eligibility Criteria:
Inclusion Criteria:

Pathologically confirmed primary focal GBM; Recurrent GBM(single or satellite lesions); Multiple (multiple germinal centers)GBM.

Exclusion Criteria:

* Photosensitizer allergy.

  * Severe coagulation disorder.

    * Patients with severe cardiovascular and cerebrovascular diseases, especially patients in the acute stage.

      * Multiple organ failure, end-stage patients. ⑤ Pregnant women: Photofrin is considered a class C pregnancy risk (toxic, non-teratogenic) drug with non-dialysis properties.

Non-gbm diagnosis: Patients with other types of brain tumors or diseases. 7 Do not agree to informed consent: patients who are unwilling to sign informed consent or do not agree to participate in the study.
Effect of Smoked Plum and Chewing Gum on Postoperative Bowel Function Following Hepatic Resection

Every patient undergoing surgery in the abdomen, such as hepatic resection, will experience temporary paralysis of bowel function. This study aims to evaluate whether smoked plum and chewing gum can reduce the bowel paralysis after hepatic resection in patients with hepatocellular carcinoma. One third of the study population will receive smoked plum, one third with chewing gum, and the last will act as empty control.

Hepatectomy is widely used to treat patients with hepatocellular carcinoma (HCC), even those with intermediate and advanced disease. Despite its well-demonstrated clinical safety and efficacy in many patients, it is associated with postoperative morbidity and mortality. One complication after hepatectomy is delayed resumption of gastrointestinal function, known as postoperative ileus. This can decrease patient comfort and increase morbidity and mortality, prolonging hospital stay and raising healthcare costs. While postoperative ileus usually resolves within approximately 3 days, it can last longer in some cases as a condition termed postoperative paralytic ileus. Postoperative use of opioid-based analgesics can increase incidence of postoperative ileus.

No drugs or interventions to prevent or treat postoperative ileus have been approved by the China Drug Administration or the US Food and Drug Administration. Several studies show that chewing gum, a new and simple modality, can accelerate complication-free recovery of gastrointestinal function following gastrointestinal surgery and obstetrical-gynecological surgery. This raises the question whether postoperative smoked plum, or chewing gum can reduce risk of postoperative ileus following hepatectomy. To examine this question, we conducted a randomized controlled trial to compare incidence of postoperative ileus and length of hospital stay in HCC patients who received smoked plum, chewing gum or no intervention following hepatectomy.

Eligibility Criteria:
Inclusion Criteria:

* Underwent open hepatic resection
* Diagnosis of HCC was confirmed by histopathological examination of surgical samples in all patients

Exclusion Criteria:

* Previously underwent exploratory laparotomy
* Laparoscopic surgery
* Known Central Nervous System tumors including metastatic brain disease
* History of organ allograft
* Substance abuse, medical, psychological or social conditions that may interfere with the patient's participation in the study or evaluation of the study results
* Any condition that is unstable or which could jeopardize the safety of the patient and his/her compliance in the study
* Pregnant or breast-feeding patients
Pathogen Identification in Pediatric Hematopoietic Stem Cell Transplant Patients With Suspected Lower Respiratory Tract Infection

This is a multicenter prospective collection of leftover respiratory tract secretions, paired blood and NP swabs, and clinical circumstances from pediatric HCT patients, followed by next generation genomic sequencing, transcriptome analysis, protein biomarker measurement, and statistical modeling.

This study is a multicenter cross-sectional observational analysis of unused lower respiratory tract secretions collected from children with a history of HCT who are undergoing evaluation for pulmonary complications. Patients will be screened and enrolled by study coordinators at each site, who will collect and submit biospecimens as well as patient characteristics and clinical outcomes. Metagenomic NGS will be performed on these biospecimens in an attempt to identify microbial pathogens and markers of host response to infection, including immune activation, inflammation, and cell damage. This study will then correlate these results with patient characteristics, clinical microbiology test results, and clinical outcomes in order to evaluate the utility of metagenomics NGS in improving the diagnosis of LRTI in our pediatric HCT population.

Eligibility Criteria:
Inclusion Criteria:

* Patients will be ≤21 years of age with a history of HCT of any type at any point in the past, and are planned to undergo clinically-indicated collection of any lower respiratory specimen, including but not limited to bronchoalveolar lavage (either via a plugged telescoping catheter such as a CombiCath, or with fiberoptic bronchoscopy) and tracheal aspirate.
* For the purposes of this study, induced or spontaneous sputum is not considered a lower respiratory tract specimen.
* Patients may have any underlying indication for clinical testing of lower respiratory secretions, including but not limited to suspected infection, non-infectious inflammation, obstructive or restrictive lung disease, pulmonary edema, pleural effusions, alveolar hemorrhage, aspiration, or pulmonary vascular disease.
* Patients who have not undergone HCT but plan to undergo HCT in the future, hereafter referred to as pre-HCT patients, may also be enrolled.
* Pre-HCT patients must have intention to undergo stem cell transplantation in the future and include but are not limited to patients with primary immunodeficiency, patients with malignancy undergoing induction or consolidation chemotherapy, and HCT patients with selected cell sources who are undergoing pre-transplant conditioning but have not yet received their cellular infusion.

Exclusion Criteria:

* Patients will not be \>21 years of age.
* Patients who do not have a clinical indication for obtaining lower respiratory secretions for testing as part of their direct patient care will be excluded.
* Patients who do not have sufficient respiratory secretions remaining after collection and aliquoting for indicated clinical tests ordered by the treating clinician will also be excluded.
* Patients who undergo lower respiratory testing solely to evaluate for relapsed malignancy will be excluded.