cyrilzakka/clinical-trials huggingface dataset:
Intraarticular Glucose Versus Hyaluronic Acid Injection for Knee Osteoarthrosis

The study is a prospective, randomized controlled, double-blind study. The enrolled patients were randomly divided into two groups: the intraarticular glucose group and the intraarticular HA group.

The glucose group underwent 3 sessions of 6cc 25% glucose injection with a 2-week interval between each treatment. The HA group was administered intra-articular HA ((Hyruan PlusR, average MW 3000 kD; LG Life Sciences Ltd, Korea)) for sessions with a 1-week interval between each treatment. The results were measured with the visual analogue scale (VAS), Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), and Lequesne index. A baseline for each test was measured before treatment and then the effects of the treatments were measured by each test at 6 and 12 weeks after treatment

Eligibility Criteria:
Inclusion Criteria:

1. people aged 45 years or more;
2. subjects diagnosed with knee OA according to the clinical criteria of the American College of Rheumatology
3. subjects diagnosed with grade II or III OA during radiological examination as defined by the radiological classification of Kellgren and Lawrence (K-L) scale for knee OA
4. subjects with tenderness in the medial tibial plateau area

Exclusion Criteria:

1. . subjects having other illnesses of neurologic diseases, cardiac disorders, hemodynamically unstable systems, or physical functions;
2. . Inflammatory arthritis or subjects with acute knee arthritis
3. . subjects who have received intraarticular injection on the affected knee within the past 3 months.
4. . subjects with previous medical histories involving the affected knee such as surgeries, cancer and maligament tumors.
How Does the Addition of Adductor Canal Block to Local Infiltration Affect Recovery in Patients Undergoing Total Knee Arthroplasty? A Feasibility Study.

The use of periarticular injection and adductor canal block are well-established techniques used both in combination or in isolation in the management of postoperative pain for patients undergoing total knee arthroplasty. The aim of this study is to investigate whether combining these two techniques have an added benefit, compared to periarticular injection alone, with respect to quality of recovery, functional return, discharge readiness, and short and long term post-operative narcotic use.

This study is a double blinded, randomized control trial. In order to create a blinded study, each participant will receive two injections; a single shot adductor canal block (ACB) and a periarticular injection (PI). All syringes will be non-identifiable to the surgeon, anesthetist and the patient.

Specifically, the two arms are:

Arm 1: PI (Ropivacaine + Ketorolac + Epinepherine) + ACB (Ropivacaine)

Arm 2: PI (Ropivacaine + Ketorolac + Epinepherine) + ACB (Normal Saline)

The aim of this study is to investigate whether combining these two techniques have an added benefit, compared to periarticular injection alone. The investigators hypothesize that the addition of an adductor canal block will translate to a superior quality of recovery, as well as an improvement in functional return, discharge readiness and less short-term and long-term post-operative narcotic use.

Eligibility Criteria:
Inclusion Criteria:

1. Patients requiring primary total knee arthroplasty
2. Patients interested in being part of the study
3. Eligible to receive spinal anesthesia

Exclusion Criteria:

1. Age \< 18 years
2. BMI \> 40 kg/m2
3. Deemed unsuitable for regional anesthesia
4. Planned general anesthesia
5. Hepatic insufficiency/Intolerance to acetaminophen
6. Renal insufficiency (defined by eGFR \<60)
7. Chronic opioid use (individuals requiring the equivalent of 1 mg or more of intravenous morphine, or 3 mg or more of oral morphine, per hour for greater than 1 month)
8. Sulpha allergy
9. Allergy or intolerance to trial medications
10. Clinical Frailty Scale Score \> 4
11. Surgery scheduled on a weekend
Characterization of Bovine Adrenal Medulla as a Model of Non-histaminergic Itch

With this experiment, the experimenter wish evaluate the role of TRPA1 on non-histaminergic itch induced by BAM8-22

With this experiment, the experimenter wish evaluate the role of TRPA1 on non-histaminergic itch induced by BAM8-22 2 (Bovine Adrenal Medulla), which is found naturally in the human body and which has proved to evoke itch. To evaluate the role of TRPA1 it will be used a TRPA1 agonist

Eligibility Criteria:
Inclusion Criteria:

* Healthy men and women
* 18-60 years
* Speak and understand English

Exclusion Criteria:

* Pregnancy or lactation
* Drug addiction defined as any use of cannabis, opioids or other drugs
* Previous or current history of neurological, dermatological, immunological musculoskeletal, cardiac disorder or mental illnesses that may affect the results (e.g. neuropathy, muscular pain in the upper extremities, etc.)
* Moles, wounds, scars or tattoos in the area to be treated or tested
* Lack of ability to cooperate •
* Current use of medications that may affect the trial such as antihistamines and pain killers.
* Skin diseases
* Consumption of alcohol or painkillers 24 hours before the study days and between these
* Acute or chronic pain
* Participation in other trials within 1 week of study entry (4 weeks in the case of pharmaceutical trials)
Dissonance Inpatient Relapse Prevention Program for Anorexia Nervosa

Anorexia Nervosa inpatient treatment has often a short-term success as weight is restored to a healthy level, but high percentage of patients relapse during the first year following the discharge. The development of strategies to overcome this problem represents a priority for clinicians. Aim of this trial is to evaluate the effects of a relapse prevention program based on cognitive dissonance theory developed for hospitalized patients.

Inpatient treatment for anorexia nervosa is often successful in restoring body weight, but a high percentage of patients relapse following discharge. The aim of the study was to assess the effect of a relapse prevention program during the last phase of inpatient treatment. Patients, when they achieve a BMI of 18.5, are randomly allocated to complete the standard cognitive behavior inpatient treatment (CBT-I) or to complete the standard CBT-I plus eight relapse prevention groups based on the cognitive dissonance. The intervention has been derived by the selective and indicated prevention programs using a dissonance-based approach. This intervention showed to be effective in reducing the risk for eating pathology onset. The primary outcome of the study is to assess the number of patients allocated to the two condition with a BMI equal or greater than 18.5 at 12-months after discharge.

Eligibility Criteria:
Inclusion Criteria:

* Female
* Body Mass Index ≥ 18.5
* Anorexia Nervosa patients admitted to inpatient treatment
* Written informed consent

Exclusion Criteria:

* Male
* Schizophrenia or other psychiatric disorders
* Substance abuse
* Medical complication that may hamper the interpretation of results (medical condition that causes weight changes)
* Absence of medical treatment (drugs) that may hamper the interpretation of results
* Pregnancy or plan to get pregnant
A Clinical Study of Regorafenib in Participants Who Have Been Treated in Previous Bayer-sponsored Regorafenib Studies That Have Been Completed

The purpose of this study is to enable participants, currently receiving regorafenib in a Bayer-sponsored clinical trial, to continue treatment after their respective study has been closed. Patients participating in this study will be observed to collect information on how safe the drugs are and how this treatment is tolerated.

The primary objectives of the study are a) to allow patients from Bayer-sponsored trials to continue regorafenib treatment after their respective study has been completed, and b) to further assess the safety of regorafenib. Secondary objective is the documentation of drug tolerability.

Eligibility Criteria:
Inclusion Criteria:

* Participant must be age-eligible in the feeder study at the time of signing the informed consent.
* Participant is currently participating in any Bayer-sponsored regorafenib study and is receiving study treatment.
* Participant is currently benefiting from treatment with regorafenib monotherapy and meets criteria to initiate a subsequent cycle of therapy, as determined by the guidelines of the feeder protocol.
* Any ongoing adverse events that require temporary treatment interruption must be resolved to baseline grade or assessed as stable and not requiring further treatment interruption by the investigator.

Exclusion Criteria:

* Medical reasons not to start the next treatment cycle in the respective feeder
* Pregnancy
Identification of Mutations Responsible for Rare Familial Skin Diseases by Next Generation Sequencing

The primary purpose of the protocol is to use next generation sequencing to identify pathogenic variants in genes involved in very rare skin diseases.

The secondary purpose will be to study the genotype-phenotype correlation in order to re-evaluate the classification of these disorders. This work could help in the understanding of the physiopathology of very rare skin disorders.


Eligibility Criteria:
Inclusion Criteria:

* patients affected by familial lipomatosis
* patients with rare dermatologic disease without molecular diagnosis
* written informed consent is obtained from the patient and his/her family

Exclusion Criteria:

* the patient does not want to participate to the protocol
* the patient is already included in another study using next generation sequencing technologies
The Clopidogrel and Aspirin After Surgery for Coronary Artery Disease

Clopidogrel is a antiplatelet agent and is effective at reducing intimal hyperplasia in animal models of thrombosis.Several large clinical trials have demonstrated that clopidogrel with aspirin can reduce ischemic events and mortality in patients with atherosclerotic disease,therefore the combination of two antiplatelets might be useful to prevent patients received coronary artery bypass graft surgery from Saphenous vein graft disease. the aim of this study is to estimate the safety and efficacy of clopidogrel and aspirin therapy versus aspirin alone in patients after CABG.


Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing primary multi-vessel CABG with at least two saphenous vein grafts, with or without the use of cardiopulmonary bypass.

Exclusion Criteria:

* Emergency surgery
* Valve surgery
* Redo CABG
* Left ventricle ejection fraction \< 30%
* Preoperative use of clopidogrel (with the exception of the current admission)
* Preoperative use of warfarin
* Allergy to aspirin or clopidogrel
* History of cerebrovascular accident
* History of severe liver disease
* Morbid obesity
* Current malignancy
Programme to Optimise Risk Factors in Patients Waiting for Coronary Artery Bypass Surgery

The time spent waiting for heart surgery can be extremely stressful. This programme aims to address this by providing a home-based, nurse-led support and education programme. Patients will be followed up in their own homes monthly by a cardiac nurse and given lifestyle advice and information to prepare them for surgery. This will be evaluated to test whether providing this support improves patients' anxiety and quality of life while they wait and also whether their blood pressure, weight and cholesterol are reduced and they have a smoother recovery as a consequence.

While waiting for coronary artery bypass graft (CABG) surgery many patients receive little if any medical and nursing input, at a time which is very stressful for them and their families. This randomised controlled trial will test whether a home-based, nurse-led support and education programme for patients waiting for such surgery can optimise mental and physical fitness and improve coronary heart disease risk factors by addressing anxiety, hypertension, obesity, diabetes and serum cholesterol in the waiting period. Patients will be followed up in their own homes monthly by a cardiac nurse and given lifestyle advice and information to prepare them for surgery. Primary outcome measurements will be anxiety, length of stay, blood pressure, cholesterol, blood glucose, smoking and body mass index. Secondary outcomes will be quality of life, and post-operative complications. Economic analysis and qualitative assessment of patients' opinion of the programme will also be performed.

Eligibility Criteria:
Inclusion Criteria:

* Patients waiting for first time cardiac bypass surgery
* Able to read and understand English

Exclusion Criteria:

* Patients living outside designated geographical area (\>1.5 hours drive from hospitals)
* Patients having surgery other than first time coronary artery bypass grafts
* Patients unable to read and understand English
* Patients with life-threatening significant non-cardiovascular disease e.g. cancer
* All risk factors under control (blood pressure \<140 systolic and/or \< 90 diastolic and/or serum cholesterol \<5 mmol/L and/or blood glucose \< 7mmol/L and anxiety score \< 8 on the Hospital Anxiety and Depression Scale).
Effect of Exercise With and Without HMB on Body Composition and Muscle Strength in Sickle Cell Anaemia

Wasting is a common and significant problem in sickle cell anaemia (SCA) that correlates with poorer clinical outcome such as frequent painful crises, acute chest syndrome and sub normal resistance to infection. Thus, improvement of nutritional status in SCA holds the potential of ameliorating the course of the disease. Elevated haemolysis and its effects are associated with hypermetabolism and have resulted in higher rates of protein breakdown and synthesis, and energy expenditure. Offering more food has not optimized nutritional status and metabolic performance in free-living patients with SCA. Moreover, appetite might be suppressed. Supplementation with β-hydroxy-β-methylbutyrate (HMB), which is produced in the body from leucine, has been shown to have inhibitory effect on protein breakdown and to promote lean tissue synthesis in humans with sarcopenia. Also, HMB has been implicated as an ergogenic tool to promote exercise performance and skeletal muscle hypertrophy. Therefore, the investigators hypothesize that in individuals with SCA, an intervention of resistance exercise with HMB supplement will have a greater enhancing effect on muscle mass and strength compared to receiving resistance exercise without HMB.

The investigators aim to measure muscle strength, body composition and whole body protein oxidation in two groups of adults with SCA within one week before and after 9 weeks of intervention in a randomized, double blinded study. One group (n =12 ) will receive an intervention of resistance exercise and HMB supplement, and the other group (n=12) will receive resistance exercise and a placebo (maltodextrin). Participants will be assigned a study code and all information and samples will be stored under the assigned code.

Eligibility Criteria:
Inclusion Criteria:

* BMI \< 18.5 kg/m2

Exclusion Criteria:

* BMI \> 19 kg/m2
12-Month Efficacy of Exercise and Cytisinicline for Tobacco Abstinence

Current scientific evidence demonstrates the relationship between good physical fitness and a lower incidence of certain chronic diseases, including smoking, as well as the effectiveness of cytisinicline. This protocol aims to evaluate the efficacy of the synergistic effect of combining structured physical exercise, brief counseling, and cytisinicline administration in achieving smoking cessation. The study will be an experimental, multicenter, randomized, and controlled trial with two parallel arms, conducted by a multidisciplinary team within the primary care setting of the Andalusian public health system, with a 12-month follow-up. The estimated sample size is 75 participants per arm. One of the study arms will include a structured exercise program aligned with the recently approved regional Andalusian health plan.


Eligibility Criteria:
Inclusion Criteria:

* Aged between 18 and 65 years.
* Smoking a minimum of 10 cigarettes per day.
* In the contemplation or action stage according to Prochaska and DiClemente's Transtheoretical Model.
* Prepared to initiate smoking cessation treatment imminently and with commitment.
* Demonstrating a high level of nicotine dependence, with a Fagerström test score of 7 or higher.
* Exhibiting significant motivation to quit smoking, as indicated by a Richmond test score of 6 or higher.
* Having made at least one prior attempt to quit smoking within the past year.
* Enrolled in or covered by the Andalusian Public Health System.

Exclusion Criteria:

* Individuals with medical conditions that contraindicate participation in physical exercise, including but not limited to malignant hypertension, heart failure, hyperthyroidism, peripheral arterial disease, or other conditions deemed by the research team to pose a risk of adverse events or significantly impair adherence to the study.
* Individuals who have experienced changes in their usual treatment regimen within the past 90 days.
* Individuals unable to provide informed consent.
* Individuals with pathological conditions that significantly reduce life expectancy to less than 5 years.
* Individuals with contraindications as specified in the product information for cytisinicline , such as pregnancy, breastfeeding, hypersensitivity to cytisinicline, unstable angina, recent myocardial infarction, clinically significant arrhythmias, or recent stroke.
Immunosuppressive Regimen on Changes in Renal Function and Transplant Rejection Rate in Patients With Lung Transplant

This retrospective single-center analyzes the impact of switch of immunosuppressive regimen on renal function and transplant rejection rate in patients with lung transplant.

Lung transplantation (LTx) is the preferred treatment modality for patients with end-stage lung disease. However, despite significant advances in treatment after LTx, comorbidities and medical complications contribute to a major extend to the high morbidity and mortality rate. Chronic kidney disease is common in patients after lung transplantation, and a large proportion of these patients ultimately progress to end-stage renal disease requiring dialysis. Chronic calcineurin inhibitor nephrotoxicity is one of the major risk factors for the development of chronic kidney disease. Mammalian target of rapamycin (mTOR) inhibitors such as everolimus have been increasingly used in combination with calcineurin inhibitors to reduce nephrotoxicity. However, whether a mTOR inhibitor based immunosuppressive regime leads to lower chronic nephrotoxicity remains unknown. The aim of this study is to evaluate whether the switch of the standard immunosuppressive regime after LTx with mycophenolate/tacrolimus/prednisolon to everolimus/tacrolimus/prednisolon is associated with an improved long-term preservation of renal function without increase in rejection rate.

Eligibility Criteria:
Inclusion Criteria:

* All patients who underwent lung transplantation at the University Hospital Giessen and Marburg, Campus Giessen and Kerckhoff Clinic Bad Nauheim

Exclusion Criteria:

* Patients who died within 3 months after lung transplantation
Comparison of Short Implant Assisted Mandibular Overdenture Designs

The aim of the study was to clinically and radiographically evaluate and compare the use of unsplinted and splinted short implants with ball abutments to support mandibular overdentures in cases with severe mandibular ridge resorption.

Twelve patients from the Prosthodontics Department in the Faculty of Dentistry, Alexandria University participated in the study. Patients were divided into 2 groups. The test group received 4 short implants with ball abutments for the construction of a mandibular assisted overdenture, while the control group received 4 short implants splinted using a bar with a ball attachment for retaining a mandibular overdenture.

Eligibility Criteria:
Inclusion Criteria:

* Completely edentulous patients.
* Mandibular ridge should be a maximum of 10mm height and with a minimum width of 8 mm to insert implants without grafting procedures.
* Patients free from systemic diseases that contradict the use of dental implants.
* Patients with class I ridge relation.
* Patients with adequate zone of keratinized mucosa.
* Patients with U-shaped or square shaped arches

Exclusion Criteria:

* Non-compliant patients based on history.
* Heavy smokers.
* Senile patients (over 75 years) with impaired neuromuscular control.
Yoga for Treating Shortness of Breath in Chronic Obstructive Pulmonary Disease (COPD)

The purpose of this study is to evaluate the safety and effectiveness of yoga in reducing shortness of breath in people with chronic obstructive pulmonary disease (COPD). Patients in this study must have moderate to severe COPD and be primarily limited by shortness of breath.

Management of dyspnea (shortness of breath) is a major concern for patients with COPD. The efficacy of complementary exercises to manage dyspnea is unknown. Complementary exercises may be more congruent with patients' lifestyles and values than traditional exercise programs and can be adapted to changes in illness severity and disability. Yoga practice is a complementary therapy that people use to manage their dyspnea. The aims of this study are to: 1) develop a safe and feasible yoga program for patients with COPD; 2) test the efficacy of this program; and 3) determine whether physical performance, psychological well being, and health-related quality of life are positively affected by yoga practice.

Patients in this study will be randomized to receive yoga training or usual care for 12 weeks. Patients will be evaluated at study entry, after each session, and immediately after the training program.

Eligibility Criteria:
Inclusion criteria:

* Able to commit to a 12-week yoga class in San Francisco, California
* Moderate to severe COPD, clinically stable for at least 1 month prior to study entry
* Forced Expiratory Volume at one minute (FEV1) \< 49% predicted after inhaled bronchodilator
* Activities of daily living limited by shortness of breath
* Ability to speak English and sign consent
* Patients receiving supplemental oxygen will be acceptable if their O2 saturation can be maintained at \> 85% on \< 6 L/min of nasal oxygen

Exclusion criteria:

* Symptomatic illness (e.g., cancer, left heart failure, ischemic heart disease, neuromuscular disease, psychiatric illness)
* Formal pulmonary rehabilitation training within 1 year prior to study entry
Intravenous Metoclopramide in the Acute Treatment of Migraine: A Double-blind, Randomized, Placebo-controlled Trial

Migraine attacks were frequently diagnosed in the emergency departments. Also intravenous metoclopramide was a commonly used drug in the acute abortive treatment of migraine. However, the role of metoclopramide was based on three randomized, placebo-controlled studies, which were carried out with relatively few patients. Those trials suggested that metoclopramide produced larger improvements in visual analog scale (VAS) scores, however they revealed conflicting results and had significant methodological problems (risk of bias, allocation of concealment, intention-to-treat analysis). The investigators aimed to analyse the effects of intravenous metoclopramide in acute migraine attacks comparing with placebo.


Eligibility Criteria:
Inclusion Criteria:

* Presenting to the emergency department with migraine attack (with aura or without aura, according to International Headache Society criteria, 2013)
* The patients older than 18 years
* Patients who agree to participate to the study by reading and signing the informed consent document

Exclusion Criteria:

* The patients younger than 18 years
* Pregnants
* Patients taking any analgesic drugs last 2 hours
* Documented or declared allergy to metoclopramide
* Patients who are hemodynamically unstable
* Patients who do not agree to participate to the study