cyrilzakka/clinical-trials huggingface dataset:
Multi-center Clinical Observation and Mechanism Study of Yunnan Baiyao in Different Stages of Diabetic Foot Ulcer

Yunnan Baiyao has been treating all kinds of wounds for 120 years, but the evidence of Evidence-based medicine that is truly convincing is insufficient, making its best application method unclear. This study explored the possible indications and use methods of Yunnan Baiyao in different stages of Diabetic foot, and obtained Evidence-based medicine evidence of clinical efficacy. Obtain the discarded tissues of Diabetic foot patients in the treatment and control groups of Yunnan Baiyao after wound debridement, conduct Transcriptome (BulkRNA seq) analysis and detection on the wound tissues, and analyze the related signal pathways and functional genes with significant differences, to help clarify the possible treatment targets of Yunnan Baiyao.


Eligibility Criteria:
Inclusion Criteria:

1. The age of the subjects is 18-80 years old;
2. Diagnose diabetes according to WHO standards;
3. Diagnosis of Diabetic foot;
4. Confirmed as one of the stages of infection progression and granulation growth;
5. Voluntarily participate in this study and sign an informed consent form.

Exclusion Criteria:

1. Severe diseases such as acute myocardial infarction, heart failure, hepatitis, shock, and respiratory failure have not been corrected yet;
2. Blood glucose is out of control, Glucose test#Fasting blood sugar\&gt;15mmol /L, Glycated hemoglobin\&gt;12%;
3. There is active bleeding inside the wound, and routine basic treatment plans cannot be implemented;
4. Serum albumin\&lt;20g/L; Hemoglobin\&lt;60g/L; Platelets\&lt;50 × 109/L;
5. Late stage subjects with malignant tumors;
6. Active period of autoimmune diseases;
7. Have a history of allergy to Yunnan Baiyao;
8. The subject is unable to cooperate or has mental disorders;
9. According to the judgment of the researcher, the subject has a clear reason that cannot be removed and affects wound healing, which is not suitable for this study or cannot comply with the requirements of this study.
Pronto-7: Accuracy of Non-invasive Hemoglobin Measurement in Parturients

The measurement of blood hemoglobin (Hb) concentration is a routine procedure in pregnant women. The assessment of Hb involves several steps, including a needle stick, blood collection, blood sample analysis in the laboratory, and waiting for the results.

Pronto-7 (manufactured by Masimo, CA, USA) is a new portable device that allows a quick bedside Hb spot check. A finger clip probe, similar to the standard oxygen finger clip probe, provides hemoglobin values in less than 60 seconds.

In this prospective observational study the investigators will assess the clinical accuracy of Pronto-7 derived Hb values compared to the gold standard laboratory Hb values in obstetric patients. We will be calculating the mean difference between Pronto-7 and laboratory Hb values. We plan to recruit 55 pregnant women admitted for vaginal or cesarean delivery at BC Women's Hospital.

Serum hemoglobin (Hb) concentration is one of the most common laboratory tests measured when a pregnant woman (parturient) is admitted for a vaginal or cesarean delivery. The Hb concentration is normally measured from a venous blood sample in clinical laboratories using co-oximetry.

A new point-of-care pulse co-oximeter, the Pronto-7 (Masimo Corporation, Irvine, CA, USA), is a portable device that offers a non-invasive and quick spot-checking of Hb (SpHb). Measurement with the Pronto-7 takes about 60 seconds and does not require the transfer of blood samples to a laboratory. In addition to SpHb, the device provides a perfusion index (PI) value (a numeric estimation of the pulse strength at the measurement site), heart rate, oxygen saturation, and finger temperature. Potential advantages of the Pronto-7 include reduced staff work, decreased exposure to potential biohazards, and reduced pain and discomfort to the patient.

A similar technology is used in Radical-7 pulse co-oximeter (Masimo Corporation, Irvine, CA, USA) for non-invasive Hb measurement. Radical-7 has been evaluated in human volunteers undergoing hemodilution, in patients undergoing spine surgeries, major urological procedures, and in critically ill patients. However, the results regarding the accuracy of this technology are conflicting.

Eligibility Criteria:
Inclusion Criteria:

* Are 19 - 40 years old
* Understand written and oral English
* Are greater than 37 weeks gestational age
* Have a singleton pregnancy

Exclusion Criteria:

* Have a laboratory Hb less than 100 g/L
* Have abnormal Hb disorders
* Have hyperbilirubinemia
* Have a peripheral vascular disease (e.g. Reynaud's syndrome)
* Have long or acrylic nails
Comparison Between Drugs for Control of Emetic Attacks During Caesarean Delivery

Single shot spinal anesthesia is widely used for most surgical operations especially in obstetric such as hysterectomy, tubal ligation after vaginal delivery, cesarean and curettage etc.; however, in general, cesarean is considered as the most common indication for spinal anesthesia in pregnant women Intra-operative nausea and vomiting/retching (NVR) may be experienced by 20% to 80% of women undergoing cesarean section (CS) with subarachnoid anesthesia (SA) in the absence of antiemetic prophylaxis.

Different treatment options are available to reduce post operative nausea and vomiting (PONV) so we will make a Comparison between Propofol, Ondansetron and Pregabalin for Control of Emetic Attacks during Caesarean Delivery with Spinal Anesthesia


Eligibility Criteria:
Inclusion Criteria:

* Age: 21-40 years old.
* Physical status American Society of Anesthesiologists (ASA)I\&II.
* Body mass index (BMI) \< 35\&\>20 kg/m2.
* Elective uncomplicated cesarean section under spinal anesthesia.

Exclusion Criteria:

* Patient refusal.
* Patients with known history of allergy to study drugs.
* Advanced hepatic, renal and respiratory diseases.
* Psychological and mental disorders.
* Patient with reduced level of consciousness.
* Hypertensive, cardiac, and diabetic patients.
* Patients receiving anticoagulants therapy or suspected coagulopathy.
A Family-based, Resilience-focused Intervention for War-affected Communities in North-eastern Democratic Republic of Congo

The main research question of the study is whether a family-based, life-skills focused psychosocial intervention is effective in reducing psychological distress and stigma and improving inter-personal relations and functioning among war-affected children in the Democratic Republic of Congo.


Eligibility Criteria:
Inclusion Criteria:

* War-affected
* eastern Democratic Republic of Congo
* Formerly abducted child or vulnerable child

Exclusion Criteria:

* severe/violent behavioural problems
* severe learning difficulties
Study of Human Microbiota in Healthy and Pathological Conditions

The aim of the present study is to characterize the bacterial composition (microbiota) colonizing to the human body in different physio - pathological conditions (lifestyle, motor activity, surgical operations, probiotic and prebiotic consumption, antibiotic therapies, chemotherapeutic therapies), nervous and musculoskeletal diseases, gastrointestinal and metabolic disorders , oral and vaginal diseases, etc.). In particular, they will be investigate:

* the changes in the bacterial abundance
* the potential microbial interactions with the human host
* the microbial networks describing on the bacterial interactions within a specific composition of the human microbiota

The main objective of this study is to deepen the knowledge about the bacterial communities associated to the human organism. In particular, the present study aims to evaluate how the microbiota (intestinal, cutaneous, vaginal, nasal, bronchial, breast milk, salivary, oral, etc.) is subject to quantitative and qualitative changes consequently to different events involving the human host. The project trys to highlight which microorganisms may be involved in the onset or progression of certain pathological condition, as well as to identify which bacterial genera can be more subject to variations due to specific non-pathological events.

Secondary objectives of this study are:

* To define a "healthy microbiome", that is to understand which are the main bacteria that commonly compose the human microbiome in physiological conditions, differentiating it from that present in certain pathological conditions.
* To characterize the physiological effects that bacterial changes of the human microbiota have on the host.
* To evaluate whether the use of probiotics, prebiotics, dietary and nutritional factors, cosmetics, and oral, nasal, vaginal, or pharmacological therapies of any kind can influence the microbial network of the human microbiota associated to different body districts.

Eligibility Criteria:
Inclusion Criteria:

* subjects suffering from neurological/behavioral diseases;
* subjects suffering of bone diseases;
* subjects affected of dysmetabolic / or endocrine disorders;
* subjects with physical activities at a competitive level;
* subjects affected of gastrointestinal disorders;
* subjects with prolonged antibiotic therapies and undergoing surgery

Exclusion Criteria:

* no use of probiotics in the month prior the sampling;
* no use of antibiotics in the month prior the sampling;
* no consumption of yogurt in the month prior the sampling;
The Influence of Silicone Oil on Nerve Fiber Layer Thickness After Pars Plana Vitrectomy

The aim of the study is to evaluate the influence of silicone oil on thickness of the retinal nerve fiber layer by using optical coherence tomography (OCT) in patients following pars plana vitrectomy.

The aim of the study is to evaluate the influence of silicone oil on thickness of the retinal nerve fiber layer by using optical coherence tomography (OCT) in patients following pars plana vitrectomy.

The study will include 60 patients with a temporary silicone oil tamponade who will be surgically treated with pars plana vitrectomy for rhegmatogenous retinal detachment and proliferative vitreoretinopathy. All subjects will be subdued to complete ophthalmologic examinations, measurements of the retinal nerve fiber layer thickness by an OCT examination, tests of the visual field with the use of an Octopus computed perimeter (automated static perimetry) and FDT-perimetry - both prior to the surgery, and on control visits for check-up during the postoperative period.

All results provided by postoperative examinations will be compared with one another.

The study is expected to provide data on the effect of the silicone oil on thickness of the retinal nerve fiber layer. It is also planned to show possibilities and advantages of OCT as a method of choice in the follow-up of patients with intraocular silicone oil tamponade.

Eligibility Criteria:
Inclusion Criteria:

- patients with rhegmatogenous retinal detachment

Exclusion Criteria:

* preexistent glaucoma
* previous retinal surgery
* placement of scleral buckle during surgery
* patients with more than 1/2 of emulsified silicone oil in anterior chamber postoperatively
* patients who develop silicone oil keratopathy postoperatively
* patients who develop silicone oil cataract which blocks visualization of posterior segment
ALRN-6924 in Patients With Advanced Solid Tumors or Lymphomas

This study evaluates the anti-tumor effects of ALRN-6924 in patients with advanced solid tumors or lymphomas with WT TP53.

Open label, multi center, Phase 1 (dose escalation) and Phase 2a (dose expansion) study design to evaluate safety, tolerability, PK, PD and anti-tumor effects of ALRN-6924, alone or in combination with palbociclib, in patients with advanced solid tumors or lymphomas with wild-type (WT) TP53. ALRN-6924 is a stabilized cell-permeating peptide designed to disrupt the interaction between the p53 tumor suppressor protein and its predominant endogenous inhibitors, murine double minute 2 (MDM2) and murine double minute X (MDMX).

The Phase 1 portion of the study will enroll adults with histologically or cytologically confirmed malignancies that are metastatic or unresectable and for which standard treatment(s) are not available or are no longer effective. The Phase 2a portion of the study consists of separate cohorts that will enroll distinct groups of patients with specific solid tumors and/or lymphomas to further investigate the clinical safety profile and potential efficacy of ALRN-6924 alone or in a combination regimen.

Treatment will continue until unacceptable toxicity, patient or physician decision to discontinue therapy or disease progression that is either symptomatic, rapidly progressive, requires urgent intervention or is associated with a decline in performance status.

Patients with PTCL have been selected as a group to be further studied in Phase 2a.

Patients with MDM2-amplified or MDM2/CDK4-co-amplified solid tumors have been selected as another group to be further studied in Phase 2a.

Eligibility Criteria:
Inclusion Criteria

* Histologically or cytologically confirmed solid tumor or lymphoma that is not amenable to standard therapies.
* Cohort specific biomarkers, including confirmed or anticipated WT TP53 (Phase 1 and PTCL expansion cohorts) and MDM2-amplification or MDM2/CDK4-co-amplification (solid tumor expansion cohort)
* At least one target lesion that is measurable by RECIST 1.1, RANO or IWG 2014, as appropriate for tumor type
* ECOG (Eastern Cooperative Oncology Group) performance status 0-1
* Adequate coagulation and hematologic function
* Adequate hepatic and renal function
* Sufficient wash out from prior therapies and recovery from all significant acute toxicities

Key Exclusion Criteria

* Prior treatment with an MDM2 inhibitor, with protocol specified exceptions
* Known hypersensitivity to any study drug component
* Protocol specified cardiovascular risk factors
* Clinically significant gastrointestinal bleeding within 6 months
* Clinically significant third-space fluid accumulation
* Active uncontrolled infection, including HIV/AIDS or Hepatitis B or C
* HPV positive tumors
* Second malignancy within two years, with protocol specified exceptions
* Pregnancy or lactation
Comparing Acupuncture, BioModulator, and Transcutaneous Electrical Nerve Stimulation for Symptomatic Treatment of Chronic Pain.

The primary objective of this preliminary study is to compare the Tennant BioModulator with Transcutaneous Electrical Nerve Stimulation (TENS) and Traditional Chinese Acupuncture for the management of chronic pain among injured service members. The secondary objective is to investigate any associative effects or benefits on sleep, Post-Traumatic Stress Disorder (PTSD) symptoms, or depression.


Eligibility Criteria:
Inclusion Criteria:

* Subjects must be Injured service members between the ages of 18 and 60, inclusive;
* The pain must have been present for 3 months or greater prior to entry into the study;
* Subjects must agree to follow the medication regime as directed by the pain clinic provider for the duration of the study;
* Subjects must be able to speak and read English and understand study procedures

Exclusion Criteria:

* Epilepsy
* Pregnancy, or considering pregnancy within the study time-frame
* Pacemaker
* History of cardiac arrhythmias
* Implantable devices (AICD, pump, etc.)
* Surgical intervention during the past month for the treatment of low back pain or its underlying etiology
* Documented history of prescription medication abuse
* Abuse of illicit drugs within the last 6 months
* Participation in a clinical trial for an investigational drug and/or agent within 30 days prior to screening
Bilateral Laryngeal Paralysis Reinnervation

Bilateral laryngeal reinnervation induces a rise in laryngeal resistance and speech alteration. The aim of this study is to propose laryngeal reinnervation by a phrenic nerve root to patients with bilateral laryngeal paralysis.


Eligibility Criteria:
Inclusion Criteria:

* Bilateral laryngeal paralysis without any amelioration for six months

Exclusion Criteria:

* Laryngeal paralysis more than 3 years
* Arycricoideus ankylostosis
* Pacemaker
* Pregnancy
Decision Impact Study to Measure the Influence of DECIPHER on Treatment Recommendations

This clinical utility study pilot is based on a review of real but de-identified and randomized patient cases and aims to evaluate Urologists' treatment recommendations before and after reviewing the results provided by the Decipher test. This is a pilot study and the primary intent is to help guide development and design of future clinical utility studies for Decipher

The primary and secondary objectives will be assessed in retrospectively selected prostate cancer patients treated with radical prostatectomy with one or more adverse pathological features (APFs)

Eligibility Criteria:
Criteria (Participant enrollment)

Inclusion Criteria Study participants:

1. Practicing board-certified urologic surgeons
2. Performing at least 40 radical prostate surgeries annually

Exclusion Criteria Study Participants:

(1) Did not meet the inclusion criteria

Criteria (Case selection)

Inclusion Criteria Case File:

Patient cases eligible for this study were treated with radical prostatectomy and have one or more adverse pathological features present defined as:

Pathological Gleason score \>= 8 or Gleason score 7 with primary pattern 4; Pathological stage T3A (= Extraprostatic extension) or T3B (=Seminal vesicle invasion); Positive surgical margins Gleason grade upgrade from biopsy to surgery

Exclusion Criteria Case File:

Metastatic disease (M+) prior to surgery Received any neo-adjuvant prostate cancer treatment with radical prostatectomy (radiation, hormone, chemotherapy)
Safety of Anticoagulant Therapy After Tissue Glue for Gastric Varices

This study aimed to clarify the safety of anticoagulant therapy after glue injection for cirrhotic variceal bleeding patients with portal vein thrombosis.

Acute esophagogastric varices bleeding is a common gastroenterological emergency. And the bleeding from ruptured gastric varices is massive and difficulty to stop, even after aggressive pharmacological and conservative treatment. Even after aggressive pharmacological and conservative treatment, maintaining patients without bleeding for a long time is still a challenging clinical problem. Endoscopic tissue adhesive injection is recommended by many international guidelines for acute hemostasis and secondary prevention of gastric variceal bleeding. However, postoperative glue extrusion is inevitable, and the the rebleeding caused by glue ulcers is a problem that is often faced in clinical work. In patients with portal vein thrombosis, the need for anticoagulation and the choice of anticoagulant drugs need to be carefully evaluated in terms of risk and benefit, as the dual conflicts of thrombosis and anticoagulation are involved. At present, there is no in-depth study or consensus on the effect of anticoagulation on rebleeding after glue injection in patients with portal vein thrombosis. This study is of great significance for the treatment and prognosis of patients with gastric varices combined with portal vein thrombosis.

Eligibility Criteria:
Inclusion Criteria:

* clinical diagnosis of cirrhosis
* Portal hypertension with gastric varices
* diagnosis of PVT by imaging examination
* undergo glue injection for gastric varices

Exclusion Criteria:

* hepatocellular carcinoma or other extrahepatic malignancy
* isolated portal cavernoma
* treatment with TIPS, thrombolysis, thrombectomy or liver transplantation
* previous long-term anticoagulation therapy for various reasons
* pregnant women
* previous endoscopic treatment of GVs
Comparison of Postoperative Visual Acuity and Spectacle Independence Between the Tecnis Multifocal Intraoculer Lens (IOL) and the Crystalens Accommodating IOL

Comparison of postoperative visual acuity and spectacle independence between the Tecnis Multifocal Intraoculer Lens (IOL) and the crystalens Accommodating IOL


Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older
* Status post bilateral cataract or refractive lens surgery (with or without LRI) and implantation of Tecnis™ Multifocal IOL or Crystalens™ AO Accommodating IOL
* Best-corrected ETDRS equivalent visual acuity of 20/30 or better in each eye
* Naturally dilated pupil size (in dim light) \> 3.5 mm (with no dilation medications) for both eyes
* Clear intraocular media (no posterior capsular opacification, or status post YAG capsulotomy)
* Availability, willingness, and sufficient cognitive awareness to comply with examination procedures

Exclusion Criteria:

* Ocular disease which could potentially limit uncorrected visual acuity or visual performance.
* Use of systemic or ocular medications that may affect visual outcomes
* Acute or chronic disease or illness that would increase risk or confound study results (e.g. diabetes mellitus, immunocompromised, etc.)
* Uncontrolled systemic or ocular disease
* History of ocular trauma
* History of ocular surgery other than that required for inclusion in this study
* Amblyopia or strabismus
* Known pathology that may affect visual acuity; particularly retinal changes that affect vision (macular degeneration, cystoid macular edema, proliferative diabetic retinopathy, etc.)
* Diagnosed degenerative visual disorders (e.g. macular degeneration, or other retinal disorders) that are predicted to cause future acuity losses to a level of worse than 20/30
* Subjects who may be expected to require retinal laser treatment or other surgical intervention
* Capsule or zonular abnormalities that may affect postoperative centration or tilt of the lens (e.g. pseudoexfoliation syndrome)
* Pupil abnormalities (non-reactive, tonic pupils or abnormally shaped pupils)