cyrilzakka/clinical-trials huggingface dataset:
Anxiety, Pain et Analgesia Nociception Index (ANI) in Palliative Care

The main objective of this study is to evaluate the correlation between ANI and pain scores and the correlation of ANI and anxiety scores in communicative patients in palliative care.

The chosen event with a risk of pain and/or anxiety is the first bed bath after admission. The secondary objectives aim to identify ANI score thresholds which would be predictive of pain and/or anxiety and to figure out some individual factors influencing ANI scores.

Pain and anxiety assessments are still challenges for palliative care teams. Anxiolytics and painkillers are the usual tools but sometimes the symptoms and so the drugs to deliver are difficult to distinguish. For patients with maintained communication abilities, pain self-assessment using Visual Analogic Scores are the gold standard. Could pain assessment be optimised thanks to ANI? ANI is used in anaesthesiology and intensive care. The ANI system is based on the analysis of intra-cardiac variability. Based as an electrocardiograph with two electrodes on the patient's chest, it measures the balance between sympathetic/parasympathetic tones leading to a pain score. This score is predictive of pain occurrence, leading to an early analgesic treatment and a better control of pain with less quantity of drugs. However, some studies reported that anxiety and emotions could influence ANI pain score.

To test this hypothesis in palliative care field, this study compares pain and anxiety VAS to ANI scores before, during and after the bed bath.

Eligibility Criteria:
Inclusion Criteria:

* admitted in palliative care

  -≥18 years old
* enough communication abilities to use VAS
* non opposition of the patient

Non-inclusion criteria :

* previous bed bath already provided to the patient in the palliative unit (anxiolytic and analgesic strategies already adapted limiting the risk of pain or anxiety and the power of the study )
* adult under legal protection (guardianship, trusteeship ...)
* contraindication of ANI : respiratory rate \< 10/min, non sinusal cardiac rythm, cardiotropic treatments
* behavioural disorders : agitation, confusion (Richmond scale score \> ou = 1)
* alertness disorders : somnolence (Richmond scale score \< ou = -1)
* no French speaking

Exclusion criteria:

* providing the bad bath is impossible
* secondary opposition of the patient
Risk Factors of Postoperative Complications and Survival Rate in Pancreatic Ductal Adenocarcinoma Patients

By evaluating the nutritional status of patients with pancreatic ductal adenocarcinoma (PDAC) admitted to Jinling Hospital, collecting relevant clinical data. we aim to conduct correlation analysis with patient clinical information, such as survival time, hospitalization time, nutritional status, hematological indicators, etc., in order to reveal the prognostic factors for overall survival and postoperative complications of PDAC patients.

Personalized and accurate survival risk prognostication remains a significant challenge in pancreatic ductal adenocarcinoma (PDAC), despite extensive research on prognostic and predictive markers. Patients with PDAC are prone to muscle loss, fat consumption, and malnutrition, which is associated with inferior outcomes. This study investigated the use of three-dimensional (3D) anthropometric parameters derived from computed tomography (CT) scans and hematological indicators in relation to overall survival (OS) outcomes and postoperative complications in PDAC patients.

A retrospective analysis was conducted on patients with PDAC, all of whom had undergone pretreatment abdomen-pelvis CT scans. Automatic 3D measurements of subcutaneous and visceral fat volume, skeletal muscle volume, and skeletal muscle density (SMD) were assessed at the L3 vertebral level by an artificial intelligence assisted diagnosis system (HY Medical). Various indicators including TyG-BMI, nutritional indicators \[geriatric nutritional risk index (GNRI) and prealbumin\], and inflammation indicators \[(C-reactive protein (CRP) and neutrophil to lymphocyte ratio (NLR)\] were also recorded.

Eligibility Criteria:
Inclusion Criteria:

* All eligible patients diagnosed with PDAC

Exclusion Criteria:

* 1) Suffering from chronic or acute diseases related to malnutrition: chronic heart failure, cirrhosis, chronic kidney disease and infection, cognitive impairment, dysphagia or gastrointestinal obstruction, etc; 2) Using excessive doses of systemic glucocorticoids within 4 weeks prior to enrollment;
Clinical Validation of the Management Process for Renal Anemia in Maintenance Hemodialysis Patients

This test aims to verify that the management process of renal anemia in maintenance hemodialysis patients can improve the hemoglobin compliance rate better than that of anemia management by primary doctors, and promote the system at the grassroots level to guide primary doctors in anemia management and improve the management standard of renal anemia in maintenance hemodialysis patients through prospective randomized controlled trials. To improve the anemia compliance rate of maintenance hemodialysis patients, and to improve the basic doctors' grasp of the anemia management guidelines, consensus and standard operating procedures.


Eligibility Criteria:
Inclusion Criteria:

① Age over 18 years old; ② Receive regular hemodialysis at least twice a week for at least 3 months, and have no plans to stop hemodialysis within 6 months since the start of the trial; ③ The patient voluntarily participated in this study.

Exclusion Criteria:

* Patients who have planned to undergo kidney transplantation or terminate hemodialysis during the study period; ② Previous history of bone marrow hematopoietic system diseases, such as combined myelodysplastic syndrome, multiple myeloma, and other diseases; ③ Any known hereditary blood disease, such as thalassemia, sickle cell anemia, pure red blood cell aplasia, etc.; ④ Active or chronic gastrointestinal bleeding; ⑤ There was a severe infection within one week prior to screening.
Unrelated Umbilical Cord Blood Following HLA-haploidentical Hematopoietic Stem Cell Transplantation in Patients With β-thalassemia Major

Allo-hematopoietic stem cell transplantation(HSCT) is the only way to cure β-thalassemia major at present. To expand donor pool，we developed a haplo-identical HSCT (Hi-HSCT) platform. But in prior Hi-HSCT using high dose post-transplant Cyclophosphamide in patients with leukemia, cytopenia post-transplant often developed, which was considered as a symptom of GVHD. Therefore, the investigators add unrelated umbilical cord blood (UCB) to the Hi-HSCT. It has reported that, as third-party cells, UCB will reduce GVHD.The purpose of this study is to determine whether unrelated UCB following Hi-HSCT can improve outcomes of Hi-HSCT in patients with β-thalassemia major.


Eligibility Criteria:
Inclusion Criteria:

* β-thalassemia major
* \< 18 year old
* Unrelated umbilical cord blood following Haplo-identical HSCT

Exclusion Criteria:

* ≥ 18 year old
* HLA- matched related donors
* Unrelated donor transplants
* Unrelated umbilical cord blood transplants
* Severe iron overload in heart by T2\*
RCT of Psychoeducational Program of Depression

The purpose of the study is to test the efficacy of a psychoeducational group program on unipolar depression

Unipolar depression is a common disorder which may be treated by drugs or psychological intervention. Many patients prefer psychological treatment, but there is a lack of professional skills and methods for effectively dealing with this in the primary health services,where most of the depressed patients are seen.For this reason it is of great importance to develop and test psychological methods which may be applied in the primary health services, as well as in the specialized psychiatric services.In the present study a psychoeducational group method is tested, with trained psychiatric nurses as the most common group leaders.

Comparison: People with unipolar depression receiving "treatment as usual"

Eligibility Criteria:
Inclusion Criteria:Unipolar depression -

Exclusion Criteria:Psychosis, other psychiatric disorders, subclinical depression, suicidal ideation, learning disabilities

-
Ranolazine SR in Patients With Chronic Angina Who Remain Symptomatic Despite Maximal Treatment With Amlodipine

The study will be a multi-national, double-blind, randomized, placebo-controlled, parallel group study to evaluate the effectiveness of ranolazine (1000 mg twice daily) in approximately 500 patients with chronic angina who remain symptomatic despite daily treatment with the maximum labeled dose of amlodipine (10 mg daily), a calcium channel blocker approved for the treatment of chronic angina. Eligible patients will be randomized to receive ranolazine 1000 mg or placebo twice daily, in addition to a daily dose of 10 mg of amlodipine. Participation in the study will last approximately 3 months.


Eligibility Criteria:
Eligible patients must have a diagnosis of chronic angina, with documented evidence of coronary artery disease or prior myocardial infarction, in addition to other study entry criteria. Prior to entering the study, patients will be required to have had at least two weeks of treatment with amlodipine 10 mg daily, with the discontinuation of all other anti-anginal therapy for the duration of the study.
Effects of Sargassum Horneri Extract on Patients With Hypersensitivity

The investigators conduct a randomized, double-blind, placebo-controlled study to investigate the effects of Sargassum Horneri Extract in patients with skin hypersensitivity for 12 weeks.

Previous studies have indicated that Panax Ginseng C.A. Mey Extract may have the ability to improve liver function. Therefore, the investigators conduct a randomized, double-blind, placebo-controlled study to investigate the effects of the Sargassum Horneri Extract in patients with skin hypersensitivity for 12 weeks; the safety of the compound are also evaluate. The Investigators examine SCORAD(SCORing of Atopic Dermatitis) score, PGA (Patient Global assessment) score, IGA (Investigator Global assessment) score, total IgE, eosinophil counts, ECP, IL-4, IL-31, and TARC at baseline, as well as after 6 and 12 weeks of intervention. One hundred adults were administered either 1,000 mg of Sargassum Horneri Extract or a placebo each day for 12 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Atopy by Hanifin \& Rajka diagnostic criteria
* SCORAD \< 40

Exclusion Criteria:

* Abnormal liver or renal function (i.e., serum aminotransferase activity \> 3 times of upper limit of reference range and serum creatinine concentrations \> 1.2 mg/dL)
* Diabetes (diagnosed clinically or fasting glucose level \> 126 mg/dL)
* History of viral hepatitis or cancer
* Uncontrolled hypertension
* History of serious cardiac disease such as angina or myocardial infarction
* History of gastrectomy
* History of medication for psychiatric disease
* Administration of oriental medicine including herbs within the past 4 weeks
Evaluation of Skin Health and QoL in Pts Receiving Anti-PD1/PDL1/CTLA4 or CDK Inhibitors.

The study aim to investigate the relationship between cutaneous adverse events and quality of life in patients taking immune check point inhibitor or cyclin-dependent kinase (CDK) 4 and 6 inhibitors by two steps. In the first one, it will be investigated the relationship between the skin toxicity related to the use selected therapies and the quality of life of patients already receiving these therapies for treatment of their cancer. In the second one, it will be evaluated the relationship between skin toxicity and quality of life over three months of treatment in patients initially naïve for selected therapies. Cancer included in the analysis are NSCLC, renal cancer, gastric cancer, breast cancer, bladder cancer, melanoma, squamous cell carcinoma of the head and neck.


Eligibility Criteria:
Inclusion Criteria:

(for all Groups)

1. Age ≥ 18 years.
2. Histological diagnosis of solid tumor.
3. Patient able to complete the questionnaires submitted during the study.
4. Signed written informed consent. (for Group I) Patients already under treatment for at least three months with anti-PD1/PDL1/ CTLA4 or cyclin-dependent kinase (CDK) inhibitors for any type of cancer. Treatment considered for each cancer are only those approved by AIFA for each tumor.

(for Group II) Patients eligible for treatment with anti-PD1/PDL1/ CTLA4 or cyclin-dependent kinase (CDK) inhibitors for any type of cancer. Treatment considered for each cancer are only those approved by AIFA for each tumor.

Exclusion Criteria (for all Groups):

1. Age \< 18 y.o.
2. Skin diseases or alterations present before the beginning of anti-PD1/PDL1 or cyclin-dependent kinase (CDK) inhibitors.
3. Chronic use of steroids.
4. Previous psychiatric disorders or patients taking antidepressant.
5. Refusal to sign written informed consent.
Analgesic Effect of Paracetamol, Paracetamol + Codeine, Ibuprofen and Their Combination

The purpose of this study is to determine whether the combination of paracetamol (acetaminophen) and other NSAIDs with or without weak opioids can give synergistic analgesic effect.

Combining paracetamol and other NSAIDs could give a theoretical synergistic analgesic effect according to already known or assumed mechanisms of action. Synergism is defined as an additive or supra-additive effect not achieved by one of the drugs alone. Such synergism is shown in clinical studies between acetaminophen and naproxen in coxarthrosis and rheumatoid arthritis. Later, a significant additive effect of 100 mg diclofenac with 1 g acetaminophen was demonstrated in a dental pain model.

One review article conclude that acetaminophen and NSAIDs may be appropriate to combine, and the combination is superior to acetaminophen, but not to NSAIDs alone. This view is contested by another review article which concludes that paracetamol may enhance the analgesic effect when added to an NSAID. In both reviews the authors also state that the clinical trials are too few, with different drug formulations, and different pain models not allowing definite conclusions.

There seems to be a need for studies investigating the potential synergistic effects of paracetamol combined with another NSAID displaying similar pharmacokinetic characteristics. To the best of our knowledge no published study has investigated the analgesic effect of the combination of ibuprofen and paracetamol, ibuprofen and paracetamol + codeine versus placebo (i.e. negative control to adjust for possible analgesic placebo effects) and the best standard analgesic treatment (i.e. paracetamol + codeine) as a positive control group.

Eligibility Criteria:
Inclusion Criteria:

* Patients of ASA class I in need of surgical removal of impacted third molars and with at least moderate postoperative pain as defined by subjective score on a verbal rating scale after surgical removal of third molars.

Exclusion Criteria:

* Females stating not suspected or not verified pregnancy after being questioned by investigator.
* Patients who have used analgesics for 3 days prior to the day of surgery.
* Patients with known active gastrointestinal bleeding or ulcer.
* Patients with any known hypersensitivity to NSAIDs.
* Patients with other drug treatment than contraceptives.
* Patients smoking before taking the test-drug or during the observation period.
* Drug addicts or rehabilitated drug addicts.
* Patients with surgery time exceeding 60 minutes
* Peroperative complications such as profuse bleeding or perforation to the maxillary sinus requiring additional drug treatment during or after the surgical removal of the third molar.
* Postoperative complications such as extended bleeding, nausea and regurgitation during the observation period.
Three-dimensional Craniofacial Phenotyping of Patients With Difficult Airway

The purpose of this study is to identify differences in craniofacial morphology and tongue size between patients who have a history of difficult airway management and a control group of patients who had an uneventful airway management during induction of general anesthesia. In this study the investigators want to validate the hypothesis that there are craniofacial phenotypic differences between patients who have a history of difficult airway management and a control group of patients who have had an uneventful airway management during the induction of general anesthesia.

Difficult airway management is one of the most challenging tasks for anesthesiologists. Recent data from the American Society of Anesthesiologists (ASA) Management Closed Claims Project \[1\] show that the percentage of claims resulting from adverse respiratory events, though on the decline (42% in the 1980s to 32% in the 1990s), continue to constitute a large source of morbidity and mortality in anesthetized patients. In 2005, a closed claims analysis of trends in anesthesia-related death and brain damage between 1975 and 2000 showed that out of all respiratory events (n=503) responsible for death and brain damage, difficult endotracheal intubation (n=115), inadequate oxygenation (n=111) and inadvertent esophageal intubation (n=66) were the top three causes \[2\].

Eligibility Criteria:
Inclusion Criteria:

* patients that had undergone or will undergo a surgery under general anesthesia .

Exclusion Criteria:

* known history of syndromal craniofacial abnormalities (e.g. Down syndrome)
* previous craniofacial surgery
* excessive facial hair which significantly obscure facial landmarks
* cervical spine fractures
* tracheostomy tube
* patients who are unable to give consent
Measures of Gait Efficiency of Three Multi-Axial, Vertical Shock and Energy Storing-Return Prosthetic Feet During Simple & Complex Mobility Activities

Many service members suffering major limb amputation(s) during active duty seek to return to active duty. The purpose of this study is to determine if biomechanic and/or bioenergtic differences exist between popular multi-function prosthetic feet that would facilitate return to duty for soldiers with amputations.

Specific Aims

* Compare the effectiveness of popular prostheses for improving performance in physically demanding tasks and environments.
* Compare amputee performance to a group of high-functioning non-amputees to determine performance differences between the groups.

Hypotheses:

Prosthetic feet with shock absorbing and torsional features will perform better in field activities. Prosthetic feet with high energy return and low mass will perform better during treadmill running. Non-amputee controls will demonstrate superior performance in all outcomes in both field and laboratory environments compared to amputee subjects.

Relevance:

This study has the potential to quantify differences between highly mobile amputees and non-amputees. Additionally, it will provide objective measures of how different prostheses may enhance mobility of soldiers with amputations. The study will compare laboratory and field measures to indicate which conditions increase efficiency of prostheses during rapidly changing mobility demands. This has the potential to permit retention of already trained soldiers.

Eligibility Criteria:
Inclusion Criteria (Amputees):

* Unilateral transtibial amputee ambulating on a K4 prosthesis for \>1yr
* K4 functional level
* Currently active duty military or other uniformed service (e.g. police), recently separated Veteran, or strong high-performance athletic history as an amputee (e.g. ranked triathlete, paralympian, etc.)
* Schedule availability and willingness to comply with study protocols
* Aged \< 45 years
* Medical clearance, within the last 6 months, for participation in vigorous physical activities

Inclusion Criteria (Non-amputees)

* Currently active duty military, ROTC, or other uniformed service (e.g. police) or recently separated Veteran, or highly accomplished recreational athlete (e.g. marathoner)
* Schedule availability and willingness to comply with study protocols
* Aged \< 45 years
* Medical clearance, within the last 6 months, for participation in vigorous physical activities
Losartan to Improve Hip Microfracture

Phase I/IIA randomized, double-blind, placebo-controlled clinical trial to assess safety and efficacy of oral losartan for improving cartilage repair following microfracture to treat focal cartilage defects during hip arthroscopy.

This is a prospective, double-blind, placebo-controlled, randomized clinical trial that will be conducted at The Steadman Clinic and Steadman Philippon Research Institute.

Articular cartilage defects that extend full thickness to subchondral bone rarely heal without intervention. Some patients may not develop clinically significant problems from acute full-thickness chondral defects, but many eventually suffer from debilitating degenerative changes. Microfracture is the most commonly used first-line treatment technique for chondral lesions in the hip, however, this procedure's effectiveness is limited by the repair tissue being a hybrid of hyaline and fibrocartilage. We hypothesize that administration of a transforming growth factor beta 1 (TGF-β1) blocker, losartan (an approved hypertension drug, angiotensin II receptor antagonist) with microfracture will enhance articular cartilage repair as assessed on quantitative magnetic resonance imaging. We will also measure patient benefit through the recording of patient reported outcomes in the 18 months following surgery. The Division of Pulmonary, Allergy and Rheumatology Products within the Center for Drug Evaluation and Research at the Food and Drug Administration has granted an investigational new drug (IND) exemption to pursue this trial in accordance with 21 CFR 312.2(b).

Eligibility Criteria:
Inclusion Criteria:

* Underwent primary hip arthroscopy
* Underwent baseline quantitative MRI at The Steadman Clinic (TSC)
* Single, localized, grade 3 or 4 cartilage lesion of the acetabulum or femoral head treated with Bone Marrow Stimulation (BMS; i.e. microfracture)
* Aged 18-60 at time of surgery
* Tonnis grade 1 or less

Exclusion Criteria:

* Two or more cartilage lesions of grade 3 or 4
* Less than 2 mm of minimal hip joint space
* Osteoarthritis or diffuse change of cartilage
* Non-English speaking
* Prior hip surgery on operative hip
* Pre-existing bony deformity caused by previous fracture(s)
* Synovial chondromatosis
* Pigmented Villonodular Synovitis (PVNS)
* Dysplasia (center edge angle \<20 degrees)
* History of Avascular Necrosis (AVN), Perthes disease, or slipped capital femoral epiphysis (SCFE)
* Inflammatory arthritis or other arthritis caused by autoimmune disease
* Patients allergic to any active or inactive ingredient of losartan
* Patients taking medication with known losartan interaction, including phenobarbital, rifampin, and fluconazole.
* Subjects that are currently taking losartan