cyrilzakka/clinical-trials huggingface dataset:
Analgesic Effects of Topical Ketamine Mouthwash in Patients Receiving Chemoradiation or Radiotherapy for Head & Neck Cancer

* The primary objective is to determine the reduction in pain score by ketamine mouthwash compared to placebo in head and neck cancer patients with refractory mucositis.
* The secondary objectives are to describe the duration of analgesia and adverse effects associated with ketamine and placebo.

We would like to determine the effectiveness of ketamine mouthwash in providing pain relief to subjects with head and neck cancer suffering from mucositis, a common adverse event of radiation therapy and chemoradiation therapy. Ketamine is a schedule III controlled substance that is generally used to provide anesthesia for short diagnostic and surgical procedures.

Ten subjects will be randomized to two treatment arms. Group A will receive ketamine on Monday, placebo on Wednesday, and ketamine on Friday. Group B will receive placebo on Monday, ketamine on Wednesday, and placebo on Friday. Each subject will swish the study drug or placebo for 2 minutes and spit it out. The use of non-maintenance mucositis medications such as DLM solution will not be allowed during the clinic visit. Subjects may resume non-maintenance mucositis medications at home.

Subjects will be asked to document adverse effects and pain scores at 30, 45, and 60 minutes after study medication. The Richmond Agitation and Sedation Scale (RASS) will be used to determine a subject's sedation level, if necessary. Treatment will last for up to 6 weeks unless an illness or an event occurs that prevents continuation, intolerance to the agent, adverse events, resolution of mucositis pain, or the decision to withdraw from the study.

Eligibility Criteria:
Inclusion Criteria:

* Subjects diagnosed with head and neck tumors (any histology) receiving ongoing chemoradiation or radiation therapy
* Subjects with mucositis pain refractory to topical management, defined as any self-reported pain score of \> 2 in the 24 hours prior to enrollment despite use of topical agents as prescribed
* Age ≥ 18 years
* Ability to understand and willingness to consent and to sign consent form

Exclusion Criteria:

* Active substance abuse at time of registration (alcohol, drugs, non-prescription use of controlled substances)
* Subjects with history of allergic reactions to ketamine
* Persistent oral bleeding: \> 15 mL (estimated) per day
* Pregnancy or breast feeding
Low Glycemic Index Dietary Intervention Program in Nonalcoholic Fatty Liver Disease

Nonalcoholic fatty liver disease (NAFLD) is the most common chronic liver disease in affluent countries. It may progress to cirrhosis and liver cancer. At present, there is no approved drug for NAFLD. Although healthy diet and exercise is often recommended, there is little supportive evidence. Therefore, the investigators plan to conduct a randomized controlled trial comparing a low glycemic index dietary intervention program and simple lifestyle advice in NAFLD patients. The primary endpoint is resolution of NAFLD. Non-invasive tests will be used to assess the study subjects. Proton-magnetic resonance spectroscopy is used to quantify hepatic triglyceride content, and transient elastography is used to quantify liver fibrosis.


Eligibility Criteria:
Inclusion Criteria:

* Age 18 to 70 years
* Fatty liver by proton-magnetic resonance spectroscopy, defined as hepatic triglyceride content 5% or above
* Serum alanine aminotransferase (ALT) above 30 U/L in men and 19 U/L in women
* Informed written consent obtained

Exclusion Criteria:

* Positive hepatitis B surface antigen, anti-hepatitis C virus antibody, or anti-nuclear antibody titer above 1/160
* Alcohol consumption above 30 g per week in men or 20 g per week in women
* Alanine aminotransferase (ALT) above 10 times the upper limit of normal
* Liver decompensation, as evidenced by bilirubin above 50 µmol/l, platelet count below 100 × 10e9/l, prothrombin time above 1.3 times the upper limit of normal, albumin below 35 g/l, presence of ascites or varices
* Evidence of hepatocellular carcinoma
* Terminal illness or cancer, unless in complete remission for more than 5 years
The AHEAD Study: Monitoring Anticoagulated Patients Who Suffer Head Injury

Existing practice in emergency departments (ED) in the United Kingdom (UK) for managing patients taking warfarin after a blunt head injury is variable with little research that supports the most appropriate way to manage these patients. The investigators aimed to undertake research in order to understand the range and frequency of outcomes following head injury in this group of patients and to develop robust clinical guidance for how they should be optimally managed in the future.

This prospective observational study aims to enrol patients taking warfarin that attend participating ED's (up to 33) in England and Scotland after blunt head injury. Over an 18-month period from Oct 2011, ED attendance data will be collected from each ED as well as information from patient questionnaires about the care the patient received and the status of their health 6-10 weeks after the injury. Patients who died due to their head injury, experienced surgery due to their injury, had a change identified on a CT scan or re-attended the ED with a clear head injury complication are defined as experiencing a poor outcome. Information such as the patients' conscious state (GCS), level of clotting in their blood (INR) and symptoms will be investigated as predictors of a poor outcome. A mathematical model will be used to estimate the most cost-effective strategy assuming published National Institute for Health and Care Excellence (NICE) thresholds for cost per quality adjusted life year (QALY).

Eligibility Criteria:
Inclusion Criteria:

* 16 years or older
* Blunt head trauma above the neck within 24 hours of ED attendance
* Prescribed warfarin

Exclusion Criteria:

* Penetrating injuries to the head, for example knife wound.
A Study to Assess Use of Zenapax (Daclizumab) and CellCept (Mycophenolate Mofetil) to Improve Kidney Function in Kidney Transplant Patients

This study will compare kidney function in kidney transplant patients following treatment with various combinations of Zenapax, CellCept, corticosteroids, and Neoral (Cyclosporine). The anticipated time on study treatment is 6-12 months, and the target sample size is 500+ individuals.


Eligibility Criteria:
Inclusion Criteria:

* adult patients greater than 18 years of age
* recipients of primary kidney transplant
* single-organ recipients (kidney only)

Exclusion Criteria:

* previous treatment with Zenapax
* history of malignancy (except localized skin cancer)
Comparison of Prognosis in Endometrial Cancer Treated With Different Surgical Methods: Laparoscopy, Robotic-assisted Laparoscopy and Laparotomy

Objective：To compare the clinical outcomes of endometrial cancer patients who received surgerical treatments: Comparisons of robotic-assisted laparoscopic, laparoscopic and laparotomic methods

We will review the medical records of clinically uterine-confined endometrial cancer women who received robotic-assisted laparoscopic, laparoscopic or laparotomic methods; and compare their outcomes.

Eligibility Criteria:
Inclusion Criteria:

* womwn who received endometrial cancer surgical from January 01, 2008 to November 30, 2022 were be reviewed.

Exclusion Criteria:

* Endometrial cancer patients did not undergo surgery.
Curio Digital Therapy for the Treatment of Post-partum Depression

Primary Objective: Evaluate the clinical effectiveness of the MamaLift Plus app compared to control (digital sham plus treatment as usual) for the management of PPD in the observed population for a period of 9 calendar weeks. It is hypothesized that women who use the MamaLift Plus APP will experience less severe symptoms of depression in post-partum period than comparable women who do not and receive their usual care from health providers.

Women between 18 and 50 years of age who have had a live birth within 3 months prior to study start date and have a diagnosis of mild to moderate PPD. A total of 200 women will be recruited to volunteer in the study with 166 assigned to the intervention arm and 37 assigned to the control group.

Eligibility Criteria:
Inclusion Criteria:

* Participants must be able to read, write and speak English; 3. Participants must provide written informed consent prior to enrollment; 4. Participants must be 18 to 50 years of age at the time of enrollment; 5. Participants must have had a live childbirth \<=3 months prior to their enrollment into the study; 6. Participants who have a score of greater than or equal to 13 but not exceeding 19 on the Edinburgh Postnatal Depression Scale (EPDS) during initial screening visit/call; 7. Depression diagnosis needs to be confirmed by licensed behavioral health therapist or medical professional; 8. Participants must answer "0/Never" or "1/Hardly Ever" to the self-harm question on EPDS (Question #10); 9. Participants must be willing to use a mobile app and own an iOS or android enabled mobile phone or device; 10. Participants must have wireless internet connectivity in their home (or have access to internet connectivity) and be willing to connect devices via a Wi-Fi network

Exclusion Criteria:

-
Preoperative Anti-PD-1 Antibody Combined With Chemoradiotherapy for Locally Advanced Squamous Cell Carcinoma of Esophagus

This study will evaluate the safety and feasibility of preoperative immune checkpoint therapy with concurrent chemoradiotherapy in patients with locally advanced esophageal squamous cell carcinoma. And this study will provide valuable information for further clinical trials of preoperative pembrolizumab and other immune checkpoint therapy in esophageal cancer treatment.

Esophageal cancer ranks the eighth most common cancer (the fifth most common cancer in China), while ESCC is the most common subtype in Asia (more than 90 % in china). Radical resection is thought to be the mainstay of esophageal cancer treatment and preoperative CRT is well applied in treating locally advanced esophageal cancer. In a multicohort, phase IB study, pembrolizumab was used in 23 unresectable esophageal cancer patients. In this clinical trial, the incidence of grade 3 treatment-related adverse events was 39 % without the appearance of grade 4 and higher-grade adverse event, while the overall response rate reached 30 %. The safety of immune checkpoint therapy for unresected esophageal cancers using nivolumab, a different PD-1 monoclonal antibody, has also been confirmed by high quality clinical trials.

This study will evaluate the safety and feasibility of preoperative immune checkpoint therapy using pembrolizumab with concurrent chemoradiotherapy in patients with locally advanced esophageal squamous cell carcinoma. And this study will provide valuable information for further clinical trials of preoperative pembrolizumab and other immune checkpoint therapy in esophageal cancer.

Eligibility Criteria:
Inclusion Criteria:

* A patient will be eligible for inclusion in this study only if ALL of the following criteria apply:

  1. Histologically confirmed cT2-T4a,N0-N+,M0 resectable esophageal squamous cell carcinoma
  2. Eastern Cooperative Oncology Group (ECOG) performance status 0-1
  3. Patients approve and sign the informed consent

Exclusion Criteria:

* 1. Patients with active autoimmune disease or history of autoimmune disease 2. Patients who have a condition requiring systemic treatment with either corticosteroids or other immunosuppressive medications 3. Subjects with a history of symptomatic interstitial lung disease 4. History of allergy to study drug components 5. Women must not be pregnant or breast-feeding 6. Men with female partners (WOCBP) that are not willing to use contraception 7. Patient has received prior chemotherapy, radiotherapy, target therapy and immune therapy for this malignancy or for any other past malignancy 8. Underlying medical conditions that, in the Investigator's opinion, will make the administration of study drug hazardous or obscure the interpretation of toxicity or adverse events
Zip® Surgical Skin Closure Device vs. Staples for Skin Closure in Subjects Having Undergone Bilateral Knee Arthroplasty

Study designed to compare the Zip Surgical Skin Closure device vs. conventional staples for wound closure following bi lateral knee replacement surgery.

Prospective, randomized, within patient control study comparing the use of Zip Surgical Skin Closure device versus conventional staple placement when utilized for surgical wound closure after bi lateral unicompartmental or bi lateral total knee replacement. A total of up to 25 patients will be enrolled and followed for up to 8 weeks post surgery to evaluate wound healing and overall satisfaction of closure method.

Eligibility Criteria:
Inclusion Criteria:

1. Patients 18 years of age and older
2. Patients requiring epidermal closure after bi lateral total or partial (unicompartmental) knee arthroplasty
3. Patients willing to be evaluated at discharge, 2 weeks, and at the 6 to 8 week post op

Exclusion Criteria:

1. Known bleeding disorder not caused by medication
2. Known personal or family history of keloid formation or scar hypertrophy
3. Known allergy or hypersensitivity to non-latex skin adhesives
4. Atrophic skin deemed clinically prone to blistering
5. Any skin disorder affecting wound healing
6. Any other condition that in the opinion of the investigator would make a particular patient unsuitable for this study
Development of a New Impedance Mapping System for Ablation of Atrial Arrhythmias in Patients

Precise identification of the atrial fibrosis is essential for successful catheter ablation of atrial arrhythmias in patients with atrial fibrillation. Voltage mapping of endocardial electrograms is currently used to delineate the anatomical substrate, but this is influenced by the direction of the activation wave front and is limited by the patient-specific thresholds. Mapping of local myocardial electrical impedance may overcome these limitations.

Clinical series: Patients with atrial arrythmias undergoing catheter ablation of these will be submitted to mapping of both voltage and tissue impedance. Likewise, the accuracy of the two maps identifying the extent of the substrate will be assesssed by gadolinium imaging. The impedance system is already constructed and certified for clinical research use.

Eligibility Criteria:
Inclusion Criteria:

* Age between 18 and 85 years.
* That they understand and sign the informed consent.
* That they do not present any contraindication.- Pass the exploration and tests prior to bioimpedance measurements.

Exclusion Criteria:

* Age outside the range described in the inclusion criteria.
* Subjects who present any type of complication during the procedure.
* Pregnancy.
Socioeconomic Deprivation and Peripheral Arterial Disease

Atherosclerosis is a systemic disease that affects coronary, cerebral, and lower-extremity arteries. Peripheral artery disease (PAD) is the manifestation of atherosclerosis in the legs. Three different stages can be found: asymptomatic stage (stage 1), exercise ischemia stage (stage 2) and rest ischemia stage (stage 3). The risk factors for PAD are similar to those for coronary artery disease (CAD) and cerebrovascular disease (CBVD), like high blood pressure, diabetes, smoking, dyslipidemia and obesity. But cigarette smoking is the single most important risk factor for the development and progression of PAD.

PAD is a serious illness and an important predictor of cardiovascular disease with major medico-economic consequences.

A low socioeconomic status (SES) is associated with higher cardiovascular mortality and morbidity. In these vulnerable populations, there is an increase in the prevalence of cardiovascular risk factors, particularly for smoking.

The main objective of this study was to assess the level of precariousness in patients with symptomatic PAD and compare it to the level of precariousness in the general population.

Patients were recruited from vascular medicine and surgery department of Grenoble university hospital or therapeutic education outpatient consultation.

The analysis of socio-economic and environmental data resulted in:

- EPICES score: (Evaluation of the Deprivation and Inequalities of Health in Healthcare Centers score). The EPICES score is a quick and validated questionnaire to assess precariousness at the individual level, developed by considering all the material and psychosocial dimensions of precariousness.

Precariousness, according to the EPICES score, in the general population is estimated at 40%.

- INSEE parameters. The investigators completed the EPICES score with more traditional indicators derived from The National Institute of Statistics and Economic Studies (INSEE) collects, analyses and disseminates information on the French economy and society. The investigators collected the level of education and professional practice based on the nomenclature of socio-professional categories defined by INSEE.

Cardiovascular risk factors were also collected to measure the links between the level of precariousness and cardiovascular risk factors.


Eligibility Criteria:
Inclusion Criteria:

* Male or female,
* Age 18 years or older,
* Symptomatic PAD (stage 2 or 3)

Exclusion Criteria:

* Pregnant woman
* Person under administrative or judicial supervision
A Study to Evaluate Safety and Efficacy of IBI306, a PCSK9 Monoclonal Antibody in Chinese Subjects With Homozygous Familial Hypercholesterolemia

A study to evaluate safety and efficacy of IBI306 in subjects with homozygous familial hypercholesterolemia.

This is a phase 2b/3 study to assess the efficacy and safety of IBI306 in subjects with homozygous familial hypercholesterolemia. Part 1 is an open-label, two-arm, multicenter pilot study to evaluate efficacy and safety of IBI306 in subjects with homozygous familial hypercholesterolemia. Part 2 is an open-label, single-arm, multicenter study to evaluate efficacy and safety of IBI306 in subjects with homozygous familial hypercholesterolemia.

Eligibility Criteria:
Inclusion Criteria:

1. Males and females ≥ 18 to ≤ 80 years of age
2. Diagnosis of homozygous familial hypercholesterolemia
3. LDL cholesterol ≥ 130 mg/dL (3.4mmol/L)
4. Triglyceride ≤ 400 mg/dL (4.5 mmol/L)
5. Bodyweight of ≥ 40 kg at screening

Exclusion Criteria:

1. History of liver transplant
2. Uncontrolled hypertension
3. Moderate to severe renal dysfunction
4. Active liver disease or hepatic dysfunction
5. Known sensitivity to any of the products to be administered during dosing
Determining the Effectiveness of earLy Intensive Versus Escalation Approaches for RRMS

The DELIVER-MS study seeks to answer the question: Does early treatment with highly effective DMT improve the prognosis for people with MS? This is an area of significant controversy and no data currently exist to guide treatment choices for patients and clinicians. The study results will help guide overall treatment philosophy and will be applicable not only to a wide range of existing therapies but also to new therapies, meeting a significant unmet need in patient decision making and aiding the decision for medication approval by third parties.


Eligibility Criteria:
Inclusion Criteria:

1. Men and women aged 18 to 60 years.
2. Established diagnosis of MS, as defined by the 2017 revision of McDonald Diagnostic Criteria (99).
3. RRMS disease course as defined by the 2013 revisions of the MS clinical course definition (4).
4. Participants must have evidence of active disease based on: one or more MS relapses within the last 18 months prior to screening visit or radiological evidence of MS activity (≥2 new T2 lesions within the last 12 months from screening \[compared to a previous recent MRI within 18 months of screening\] or ≥1 GdE demonstrated on brain or spinal cord MRI performed within the last 12 months of screening).
5. Participants must be ambulatory with disease onset ≤ 5 years and treatment-naïve (i.e., no MS DMT at any time in the past).
6. Participants must be eligible to receive at least one form of DMT within each treatment arm.
7. EDSS at Baseline visit ≤ 6.5

Exclusion Criteria:

1. Participants with contraindications to all forms of DMT in either of the treatment arms.
2. Participants must never have received any of the following medications: natalizumab, alemtuzumab, ocrelizumab, rituximab, ofatumumab, cladribine, siponimod, interferon beta-1a, interferon beta-1b, pegylated interferon beta-1a, glatiramer acetate, fingolimod, teriflunomide, dimethyl fumarate, daclizumab, mitoxantrone, diroximel fumarate, ozanimod, monomethyl fumarate, ponesimod.
3. Participants must have not received any of the following medications, for reasons other than MS, in the last 12 months: cyclophosphamide, azathioprine, mycophenolate mofetil, cyclosporine, methotrexate, leflunomide, laquinimod, atacicept, other monoclonal antibodies.
4. Participants with clinically relevant medical or surgical conditions that, in the opinion of the investigator, would put the subject at risk by participating in the study
5. Participants unable to provide informed consent.
6. Contraindication or inability to undergo MRI with Gd due to metal or metal implants, allergy to Gd contrast, claustrophobia, pain, spasticity, or excessive movement related to tremor.
7. Unwillingness or inability to comply with the requirements of this protocol including the presence of any condition (physical, mental, or social) that, in the opinion of the PI, is likely to affect the participant's ability to comply with the study protocol.
HLA Matching - Unrelated Umbilical Cord Blood Transplantation

The aim of this protocol is to clarify the role of HLA matching in unrelated umbilical cord blood (UCB) transplantation and to identify the level of HLA matching required assuring successful outcome of unrelated UCB transplantation.

The aim of this protocol is to clarify the role of HLA matching in unrelated umbilical cord blood (UCB) transplantation and to identify the level of HLA matching required assuring successful outcome of unrelated UCB transplantation.

The study will answer the following questions:

1. Is HLA matching beneficial to unrelated UCB transplantation?
2. Which HLA loci, HLA-A, B, C, DRB1, or BQB1 is/are important to math, or alternatively to mismatch, to improve graft survival?
3. Which HLA loci, HLA-A, B, C, DRB1, or BQB1 mismatches is/are "permissive mismatches" or well tolerated mismatches?
4. What level of typing resolution (low, intermediate, or hgh) is required to perform patient/donor H:A matching?

By studying the cells and blood of donors and recipients, we may learn more about improving the tissue matching between unrelated donors and their recipients. Also, we hope to learn if an additional level of matching testing improves the results of the transplant treatment. Increasing knowledge about tissue matching could result in the improved long-term survival of cord blood transplant recipients.

Eligibility Criteria:
Inclusion Criteria:

* Pediatric Patients undergoing an unrelated umbilical cord blood transplantation.

Exclusion Criteria:

* Refusal to participate in study.
A Trial Evaluating the Role of Sildenafil in the Treatment of Fetal Growth Restriction

This is a Randomized Controlled Trial to evaluate the effect of sildenafil on Doppler velocity indices of the umbilical arteries in patients with placental insufficiency and fetal growth restriction, and if sildenafil can improve fetal and neonatal outcomes in those patients.


Eligibility Criteria:
Inclusion Criteria:

* Pregnant women, singleton pregnancy, gestational age 24-34 weeks, with

  * Fetal growth restriction.
  * Intact membranes.
  * Abnormal umbilical artery Doppler waveforms.
* Fetal abdominal circumference at or below the tenth percentile.
* Normal venous fetal Doppler

Exclusion Criteria:

* Undetermined gestational age.
* Intrauterine infection.
* High Risk for aneuploidy (e.g. maternal age ≥40 years, detected congenital fetal anomalies in the current or previous pregnancies).
* Maternal cardiovascular morbidity.
* Users of any vasodilator agents.
* Known allergy to sildenafil citrate