cyrilzakka/clinical-trials huggingface dataset:
Economic Evaluation in Teledermatology

Introduction: Previous studies confirm that teledermatology allows the generation of a quick response from the specialist's consultation, reduction of unnecessary travels, early diagnosis and priority in the attention to the most urgent cases. Despite these advantages and that teledermatology has experienced exponential growth since its introduction approximately 16 years ago in Spain, in Andalusia, its use is still very limited. The objective of this project will be to carry out an analysis of the quality of life related to health, costs, cost-utility and informal care of teledermatology services in Primary Care compared to conventional monitoring carried out at the Hospital de Poniente.

Methodology: A randomized, controlled, unmasked, inter-level clinical trial (Primary Care-Hospital de Poniente) and multicentre (all health centers attached to the Poniente Health District of Almería) will be carried out with a 6-month follow-up. Patients will be assigned to the teledermatology group (experimental) or the conventional monitoring group in the hospital (control). The patients included in the experimental group will be monitored asynchronously. Baseline characteristics, number of visits to the hospital, health-related quality of life, costs, informal care and satisfaction from the perspective of the Andalusian Public Health System and patients and their caregivers will be analyzed. The generic EuroQol-5D questionnaire (EQ-5D) will be administered to assess health-related quality of life and the SKINDEX-29 quality of life dermatological questionnaire. A cost-utility analysis will be performed to assess whether tele-dermatology is cost-effective in terms of additional cost for additional quality-adjusted life years (QALYs).


Eligibility Criteria:
Inclusion Criteria:

* 1. Be over 18 years old.
* 2. Having any skin disease.
* 3. Accept to participate in the study.

Exclusion Criteria:

* 1. Non-dermatological disease.
* 2. Be participating in another study.
* 3. Refuse to participate in the study.
To Assess the Bioequivalence of Brotizolam Tablets 250 Mcg vs. Lendormin Tablets 250 Mcg Administered to Healthy Adult Volunteers

The objective of the study was to assess the bioequivalence of Lendormin Tablets (Delpharm Reims) vs. Lendormin Tablets (Synmosa Biopharma Co. Ltd.) following oral administration


Eligibility Criteria:
Inclusion criteria:

1. Healthy volunteers, provision of signed written informed consent before enrolment into the study, ability to communicate with the investigators, and to understand and comply with the requirements of the study.
2. Healthy adult male, aged between 20 and 40 years old.
3. Body Mass Index (BMI) between 18.5 and 25, inclusive, (BMI will be calculated as weight in kilogram \[kg\]/height in meters2 \[m2\]).
4. Physically and mentally healthy subjects as confirmed by an interview, medical history, clinical examination, chest x-ray and electrocardiogram.
5. No significant deviation from normal biochemistry examination.
6. No significant deviation from normal haematology examination.
7. No significant deviation from normal urinalysis examination.

Exclusion criteria:

1. History of drug or alcohol abuse within the past one year.
2. Medical history of allergic asthma or sensitivity to analogous drug.
3. Evidence of chronic or acute infectious diseases from 4 weeks before the study.
4. Evidence of any clinical significant renal, cardiovascular, hepatic, hematopoietic, neurological, pulmonary or gastrointestinal pathology.
5. Ongoing peptic ulcer and constipation.
6. Planned vaccination during the time course of the study.
7. Taking any clinical investigation drug from 3 months before the study.
8. Use of any medication, including herb medicine or vitamins from 4 weeks before the study.
9. Donation of greater than 250 ml of blood in the past 3 months prior to dosing or donation of 250 ml of blood in the past 2 months prior to dosing.
10. A positive Hepatitis B surface antigen or positive Hepatitis C antibody result.
11. A positive test for HIV(Human immunodeficiency virus) antibody.
Number One Overall Graft Pick? Hamstring vs Bone-Patellar-Tendon-Bone vs Quadriceps Tendon

The main purpose of this study is to determine if there is a difference in graft re-injury/failure rates between participants that have had an ACL reconstruction with a STG, BPTB or QT autograft. Additionally, to compare quality of life, patient reported outcomes and functional performance after ACL reconstruction with STG, BPTB and QT.

The main purpose of this study is to determine if there is a difference in graft re-injury/failure rates between participants that have had an ACL reconstruction with a STG, BPTB or QT autograft. Additionally, to compare quality of life, patient reported outcomes and functional performance after ACL reconstruction with STG, BPTB and QT.

Quasi-randomized clinical trial

Eligibility Criteria:
Inclusion Criteria:

* - confirmed diagnosis of a complete primary unilateral ACL rupture based on all of the following:
* history of a traumatic injury episode
* physical exam findings of increased anterior translation of the tibia on the femur (Lachman test and/or anterior drawer test)
* positive pivot shift test
* patients must be 14 to \</= 50 years (at time of surgery)
* x-rays showing skeletal maturity (i.e. tibial tubercle fused) and no fractures
* MRI prior to surgery (note: if the radiologist's report states an incomplete or partial ACL on MRI but the surgeon diagnoses the patient with a complete unilateral tear based on the clinical criteria above, then the patient will be considered eligible. Final eligibility will be determined intra-operatively.)

Exclusion Criteria:

* - ACL rupture on contra-lateral limb
* Partially torn ACL \*final determination made intra-operatively
* Concomitant medial collateral, lateral collateral, or posterior collateral ligament tears requiring surgical repair \*final determination made intra-operatively
* Severe chondromalacia (Grade IV on the ICRS scale) \*final determination made intra-operatively
* ACL reconstruction using allograft tissue
* Confirmed connective tissue disorder
* Unwillingness to be followed for 24 months post-operatively
* History of rheumatoid arthritis
* Pregnancy (at the time of surgery)
* Psychiatric illness that precludes informed consent
* Unable to speak, read or understand the English language
* Major medical illness (life expectancy less than 1 year or unacceptably high operative risk)
Breakfast Intake and Satiety Hormones

The experiments in this study will assess if while following a reduced energy diet, eating a breakfast with higher protein quality will enhance weight loss compared to another breakfast with lower protein quality, but matched for energy density and macronutrient composition.

There will be 2 experiments in this pilot study. Both will be randomized crossover study designs with subjects beginning on either an egg breakfast of higher protein quality or cereal breakfast of lower protein quality, and reversing to receive the breakfast not previously ingested. The subjects will consume breakfasts under supervision at our clinic on all days of the study, except for weekends. Subjects will be advised to continue eating their breakfast at home on weekends. All subjects will receive weight loss counseling and follow a weight loss diet for 2 weeks. Experiment 1 will test the hypothesis that when on a reduced calorie diet, intake of an egg breakfast compared to cereal breakfast increases satiety, reduces lunch time energy consumption and reduces dinner time energy consumption in clinical and free living condition. Insulin, glucagon-like peptide-1, peptide YY 3-36, ghrelin, plasma glucose, baseline and post intervention anthropomorphic measurements, and hunger questionnaires completed during the consumption of both breakfasts and subsequent meals will be compared. Experiment 2 will compare the effects of the two breakfasts on intake of foods considered tempting or highly palatable, and assessment of energy intake pre/post test lunch followed by offering brownies. It is hypothesized that consumption of an egg breakfast compared to cereal breakfast, will help in reducing intake of foods considered tempting.

Eligibility Criteria:
Inclusion Criteria:

* Calculated BMI of 25.0-39.9 kg/m2
* Sedentary (\< 3 hours/week of moderate intensity physical activity)
* Otherwise healthy

Exclusion Criteria:

* ≥5% body weight loss or gain in the three months preceding the study
* Post-menopausal (has not had period for 12 months)
* Plans to begin an exercise program or change current exercise routines between initiation of study and final study
* Anyone following a medical diet prescription
* Anyone with a chronic disease including type II diabetes, hypothyroidism, hypoparathyroidism, cardiovascular disease, cancer of any type
* Health conditions and chronic illness that contraindicate behavioral weight loss treatment using a low calorie diet
* Anyone who is currently pregnant, or lactating
* Medications that may influence or inhibit appetite, sensory functioning, or hormone signaling
* Plans to begin taking any supplements that may influence weight loss
* Report of medical condition or surgical intervention that affects swallowing or chewing ability
* Anyone with a pacemaker or other internal medical device
* Any practicing vegans or vegetarians
* Any practicing gluten-free diet
* Allergy, aversion, or dislike to any of the foods offered for meals
Effect of Laser Acupuncture Augmented by Abdominal Exercises on Abdominal Fat

the aim of study is to investigate the effect of laser acupuncture and abdominal exercises on abdominal fat in breast feeding women

Forty breast feeding women aged between 20 and 35 years will recruited to the study in the women health department faculty of physical therapy clinic, kafr el sheikh university , Egypt. The evaluation procedures will explained to each participant. participants will be divided into two groups Group A : received laser acupuncture, diet modification and abdominal exercises Group B: received diet modification and abdominal exercises only

Out come measurement BW, BMI, body fat mass (BFM), body fat percent, waist girth, hip girth, and waist-to-hip ratio (WHR) were measured at baseline and the end of treatment. BW, BMI, BFM, and body fat percent were measured using the body composition analyzer (Model Inbody 3.0, Republic of Korea).

Eligibility Criteria:
Inclusion Criteria:

* All participants are free from any medical problems such as diabetes mellitus, hypertension and thyroid dysfunction.

All participants do not use any hormonal contraceptive method.

Exclusion Criteria:

* Participants will be excluded if they had diabetes, hypertension, cardiac diseases, patients who had endocrine disease or digestive tract disease and patients with neurological or musculoskeletal disorder.
The Addition of Hydromorphone to Local Anesthetics for the Repair of Inguinal Hernias in Elderly Patients

To compare the clinical and postoperative analgesic effects of hydromorphone combined with ropivacaine and ropivacaine alone in quadrangular muscle block for open inguinal hernia in elderly patients.

Elderly patients selected for Lichtenstein hernia repair in our hospital who met the inclusion and exclusion criteria and obtained informed consent were included in this trial, and were randomly divided into experimental group by random number table method: 0.375% ropivacaine combined with hydromorphone block group, and control group: 0.375% ropivacaine block group alone.

Eligibility Criteria:
Inclusion Criteria:

* Age 60 and above.
* Admission to hospital for open inguinal hernia surgery is consistent with the -indications of this surgical modality, ASA grades 1 to 3.
* No recent use of sedatives, opioids, or other analgesics.
* Good compliance, signed informed consent.
* Complete clinical data.

Exclusion Criteria:

* There are serious cardiovascular and cerebrovascular diseases.
* Abdominal infection.
* Coagulation dysfunction or receiving anticoagulation therapy.
* Local anesthesia drug allergy.
* Can not cooperate with the corresponding operation, suffering from mental illness.
* Previous surgical history of the corresponding position in the abdomen that may interfere with the surgical process of this study.
Safety and Efficacy of Etrasimod (APD334) in Patients With Ulcerative Colitis

The purpose of this study is to determine whether etrasimod is a safe and effective treatment for ulcerative colitis.


Eligibility Criteria:
Inclusion Criteria:

* Moderately to severely active ulcerative colitis defined as a 3-component Mayo Clinic score
* Evidence of colonic ulcerative colitis activity on endoscopy

Exclusion Criteria:

* Within 30 days prior to randomization, receipt of any of the following for the treatment of underlying disease: Non-biologic therapies (eg, cyclosporine, tacrolimus, tofacitinib, thalidomide), a non-biologic investigational therapy or an approved non-biologic therapy in an investigational protocol
* Within 60 days prior to randomization, receipt of any of the following: Infliximab, adalimumab, golimumab, certolizumab, vedolizumab, any other investigational or approved biologic agent
* Any prior exposure to natalizumab, efalizumab, or rituximab
Prognostic Value of Circulating Tumoral DNA After the First 6 Months of Treatment in Patients With Waldenström Macroglobulinemia

Waldenström Macroglobulinemia (WM) is defined by a bone marrow lymphoplasmacytic infiltration and the presence of a monoclonal immunoglobulin M (IgM) in blood. This chronic lymphoproliferative disorder requires treatment only in case of symptoms, according to accurate criteria described during the second Workshop on WM i.e. in case of cytopenia, bulky organomegaly, immunological or physicochemical consequences of the presence of IgM in circulating blood. A MYD88 mutation, typically a MYD88(L265P), is found in 90% of WM patients. Other gene abnormalities have been observed, the most frequent is a mutation in the CXCR4 gene. Overall, gene mutations in WM involve only a limited number of signalling pathways, yielding the activation of NFkB, namely : the TLR and MYD88 pathway (with an activation of NFkB and BTK in case of MYD88(L265P) mutation), the BCR pathway (involving btk and associated with activations of both NFkB, and erk akt pathway) and the CXCR4 pathway (CXCR4 is a receptor of CXCL12, it is also associated with activations of ERK/MAPK and PI3K). Abnormalities of some of genes, such as TP53, of the expression of the protein CXCL13 and genes involved in the interleukin 6 secretion have been associated with some clinical characteristics.

The purpose of this project is to define the prognostic role of the detection of circulating tumoral DNA (ctDNA) at the end of treatment for the progression/relapse risk within the first 3 years after the first 6 months of treatment.


Eligibility Criteria:
Inclusion Criteria:

* Patient with WM according to diagnostic criteria
* Patients with WM followed in one of the centre of North-Western region.
* Patients requiring first-line or subsequent-line therapy
* Patients agreement for giving informed consent.
* Social insurance system affiliation

Exclusion Criteria:

* Patients with another chronic B-cell malignancy
* patients with other lymphoplasmacytic proliferations
* patients with marginal zone lymphoma.
* Patients with WM and histologic transformation
* Absence of informed consent
New Biopsy Technique for Uveal Melanoma

This pilot study intends to investigate a new biopsy technique that will decrease the incidence of tumor cells in the biopsy tract.

Uveal melanoma is the most common primary malignancy of the eye and is one of the few fatal diseases that are detected initially through an eye examination. For many years, clinical decision-making regarding which patient with uveal melanoma required treatment has been based solely on clinical features observed at the time of diagnosis. These features include: tumor size as measured by ultrasound, associated subretinal fluid, presence of orange lipofuscin pigment, lack of drusen, posterior location, and ciliary body involvement. All of these clinical features have been demonstrated to be associated with tumor growth which is associated with the eventual development of metastases. However, these clinical features are not adequately sensitive or specific enough to predict which patients will develop metastases.

More recently, researchers studying the genomics of uveal melanoma have focused on identifying genetic abnormalities present in tumor tissue in order to characterize these lesions more fully. Several landmark papers over the past 15 years have reported cytogenic and genomic abnormalities in uveal melanoma tumor tissue that are associated with a poorer prognosis. Although rare, there have been at least five cases in which patients undergoing biopsy of these lesions have developed extraocular spread of melanoma from the biopsy sites. With this new technique, the possible rate of extraocular spread should be lower, making the biopsy a safer technique than what is currently in practice.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with uveal melanoma
* Scheduled for enucleation surgery

Exclusion Criteria:

* Patients under 21 years old
* Patients unable to undergo surgery
* Patients with known metastatic uveal melanoma or other cancer.
Anaesthesia for Supratentorial Tumor Resection

This is a double center, multidisciplinary, prospective, randomized, double-blind, with a superiority hypothesis, trial including 100 patients scheduled for resection of a supratentorial brain tumour under general anesthesia.

On the morning of surgery, patients will be randomly allocated to one of the two following groups : target concentration-delivered propofol-remifentanil versus sufentanil-sevoflurane. The primary judgement criterion will be the rapidity of awakening, defined as the time between the cessation of administration of the last anesthetic until extubation. Several secondary judgement criteria related to quality of postoperative recovery and complications will be collected. The hypothesis tested is a 30% reduction of the time necessary to extubate patients after cessation of anesthetic delivery in the propofol-remifentanil group. Based on previous works, using an risk of 20 % and an of 5 %, 100 patients must be included in this study (50 or each group). Statistical analysis will be performed by WILCOXON MANN, WHITNEY and X2 tests based on the type of variables.

The results of this study should provide a first choice anaesthetic regimen to optimize postoperative recovery of neurosurgical patients undergoing resection of supratentorial brain tumours. They will contribute to the improvement in the management of patients suffering from cancer.

Eligibility Criteria:
Inclusion Criteria:

* Patient scheduled for supratentorial brain tumors remove.
* Age : 18 to 75.
* ASA 1 or 2.

Exclusion Criteria:

* Disagree of patient to participate
* Intubation required in the postoperative care unit
* Contraindication of one of the anesthetics used in the study
* Pregnancy
* Craniotomy in the frontal area (no depth of anesthesia monitoring)
* Patient's inability to quantified its pain.
The Immediate Effect of Combined Terminal Knee Extension Exercise With Audible Cues

Typically, patients perform TKE by themselves after exercise prescription. The investigators thought that a lack of attention and preferred speed of patients might not provide the best outcome. Therefore, an increased effectiveness of TKE is interesting for physical therapy implication. Besides, adding sensory input which is audible cues or rhythm during exercise may enhance the efficacy of the exercise by increasing neuromuscular control and function.

Therefore, the study aimed to investigate the immediate effects of combined TKE with audible cues on motor unit behavior. The researchers expect that adding rhythm from the metronome will enhance neuromuscular control which may change motor unit behavior of VM muscle. The findings of the study may have helped explain the mechanism behind the acute effects of combined TKE with audible cues on VM function and their potential application in the field of physical therapy.

This study aims to investigate the immediate effect of combined TKE with audible cues on motor unit behavior in healthy participants and to investigate reliability of decomposition electromyography procedure during single leg squat.

A metronome will be used to provide rhythmic exercise. Participants will stand with their feet in line with their shoulders as starting position and straping at the knee. Exercise intensity is 60% of the 1RM weight. At the beginning of the exercise, participants will be asked to bend their knees following the pull of the resistance and exert force to straighten the knee (10 times/set and 3 sets). 180 seconds of resting will be allowed between sets.

Eligibility Criteria:
Inclusion Criteria:

* Aged range between 18 and 30 years
* BMI of 18.5-25 kg/m2
* Male or female
* Lightly active or sedentary {Physical activity level (PAL= 1.4-1.69)}

Exclusion Criteria:

* History of serious injury or operation of lower back and lower extremities such as fracture
* Musculoskeletal problems of lower back and lower extremities in 6 months before the study
* Single-leg stance test \< 43 seconds (26). and range of weight-bearing lunge test \< 9.1 cm
Short-term Effects of Tai Chi Chuan Exercise on the Regulation of Lipid and Glucose Metabolisms and Endothelial Function

The short term effects of TCC exercise are the significant increase in serum insulin and insulin resistance, and the significant decrease in serum TC, HDL-C, ET-1 and insulin sensitivity in TCC practitioners. TCC might be benefit the health of its practitioners through the regulation of lipid and glucose metabolism and endothelial function.

Tai Chi Chuan (TCC) has been shown to be beneficial to the health. However, its effects on lipid and glucose metabolism are not fully understood. This study investigated the short term effect of TCC exercise on lipid and glucose metabolism and endothelial function in TCC practitioners. Twenty-one TCC practitioners and nineteen normal controls were included in this study. The hemodynamics, serum insulin, indices of insulin resistance/sensitivity, serum endothelin-1 (ET-1), blood lipids and aldosterone before and 30 min after a rest or a session of classical Yang's TCC exercise were compared.

Eligibility Criteria:
Inclusion Criteria:

* TCC practitioners in a TCC training center in Taiwan over 50 years of age
* Healthy subjects without TCC experience over 50 years of age

Exclusion Criteria:

* Subjects who had major cardiopulmonary disease
* Subjects who have diabetes mellitus, renal or liver disease