cyrilzakka/clinical-trials huggingface dataset:
Descriptive Study to Evaluate the Understanding Degree of Informed Consent in Surgical Procedures

The Informed Consent (IC) of a medical procedure is the aceptation of a diagnostic or therapeutic procedure by the patient, after receiving the necessary and accurate information about it. Freedom, information and understanding have to be the main requirements in this proccess.

The main goal of this study is to assess if patients that are going to be operated at Hospital de la Santa Creu i Sant Pau in the CSI (Surgery without previous hospitalization) unit, really understood the information about the procedure.


Eligibility Criteria:
Inclusion Criteria:

* Undergoing surgery and admitted by CSI unit
* Provide written informed consent to participate in the study

Exclusion Criteria:

* Patients who need a legal representative to read, understand and sign the CI
The Effect of Biomechanical Scapular Mobilization With Movement and Motor Learning

the study about new mobilization technique used in shoulder impingement syndrome patient to increase the range of motion of elevation, decrease the pain, and increasing the function level, this technique is based on normal mechanics that occur inside the joint during certain movement.

The study is about a new technique of mobilization based on normal biomechanics that occurs during the movements of a joint. For example, shoulder abduction or elevation needs the scapula to move upward rotation with posterior tilt and external rotation. Moreover, needs glenohumeral (GH) joint glide inferior and posterior these movements occur normally to permit us to elevate our shoulder without any restriction and the full range of motion(ROM). so in the patients with shoulder problems and have difficulties reaching full ROM of elevation the investigators applied mobilization of scapula toward upward rotation with external rotation and posterior tilt and by using mobilization belt applied posterior and inferior glide to GH joint. However, mobilization techniques have a short-term effect to enhance this effect, the investigators adding a motor learning approach to achieve a long-term effect and prevent recurrent .the investigators applied this technique 3 times per week for 3 weeks.

Eligibility Criteria:
Inclusion Criteria:

clinical diagnosis: shoulder impingement syndrome.

1. History of shoulder pain when they elevated their arm.
2. Limited range of motion due to the pain.
3. Pain localized at the painful point at proximal anterolateral shoulder region or medical diagnosis of shoulder impingement syndrome with at least 2 positive impingement tests including Neer, Hawkins, or Jobe test.

Exclusion Criteria:

* Fibromyalgia.
* Fracture, dislocation, or subluxation of the shoulder.
* history of trauma.
* shoulder surgery.
* numbness or tingling in the upper limb.
* Corticosteroids injection within 1 year.
* systemic illness.
* ligamentous laxity
Biweekly TPF Induction Chemotherapy for Locally Advanced Squamous Cell Carcinoma of Head and Neck

This study aimed to assess the efficacy and safety for biweekly TPF as induction chemotherapy for locally advanced head and neck cancer

After being informed the study and potential risk, patients was provided written informed consent prior to initiating therapy. The chemotherapy regimen including docetaxel, cisplatin, 5-fluorouracil, and leucovorin was administered every 14 days for six cycles or until disease progression or intolerant treatment toxicity.

Eligibility Criteria:
Inclusion Criteria:

1. The patient has histopathologically or cytologically confirmed diagnosis of stage 3 or 4 squamous cell carcinoma of the oral cavity, larynx, oropharynx or hypopharynx.
2. The patient has local advanced, and no distant metastatic, and unresectable disease.
3. The patient has measurable or valuable disease. 4 Age ≥ 20 years.

5. ECOG performance status 0, 1 or 2 at study entry. 6. Life expectancy ≥ 3 months. 7. The patient must have adequate organ function, defined as: 7a Absolute neutrophil count (ANC) ≥ 1.5 x 109/L; Platelets ≥ 100 x 109/L; Hemoglobin

* 9.0 g/dL. 7b Total Bilirubin ≤ 1.5 times upper limit of normal (ULN); Aspartate transaminase (AST) and alanine transaminase (ALT) ≤ 2.5 x ULN. 7c Alkaline phosphatase ≤ 2.5 x ULN. 7d Serum creatinine ≤ 1 x ULN or creatinine clearance ≥ 60 mL/min/1.73 m2. 8. Signed informed consent. 9 Women of child-bearing potential and men must be willing and able practice adequate contraception prior to study entry and for the duration of study treatment.

Exclusion Criteria:

1. The patient had previous chemotherapy or radiotherapy for squamous cell carcinoma of head and neck.
2. The patient has uncontrolled disorder(s), serious illness or medical condition(s) is/are not be enrolled to study that be confirmed by investigator.
3. Previous or concurrent malignancy except for basal or squamous cell skin cancer and/or in situ carcinoma of the cervix, or other solid tumors treated and without evidence of recurrence for at least 3 years prior to the study.
4. Peripheral neuropathy \> Grade 2.
5. The patient is pregnant or breastfeeding.
Real-World Pharmacological Treatment Pattern of Neuropathic Pain in China

The aim of this study is to investigate the pharmacological treatment pattern among patients with diabetic peripheral neuropathic pain (DPNP) and chemotherapy-induced peripheral neuropathy (CIPN) in China.

Diabetic peripheral neuropathic pain (DPNP) and chemotherapy-induced peripheral neuropathy (CIPN) are common subtypes of neuropathic pain. The treatment pattern, subsequent medication usage, and adherence information of medication among these patients are still not clear. There is also an unmet need for the use of relevant analgesic medications in this area. This real-world data study aims to understand patients' characteristics, clinical diagnosis and treatment patterns, medication adherence, real-world effectiveness among DPNP and CIPN patients in China and will explore the current unmet needs of DPNP and CIPN, in order to inform physicians' decision-making in clinical practice

Eligibility Criteria:
Participants who meet all the following criteria will be included in the DPNP cohort.

1. Participants were diagnosed with diabetic neuropathy and presented with the pain symptom between 1st January 2018 and 31st December 2021;
2. Participants received at least one targeted medication between 1st January 2018 and 31st December 2021;
3. Participants were ≥18 years on the index date;
4. Participants had at least one medical visit record within 12 months after the index date

Participants who meet any one of the following criteria will be excluded from the DPNP cohort.

(1) Participants were diagnosed with epilepsy, schizophrenia, or bipolar disorder before or on the index date

Participants who meet all the following criteria will be included in the CIPN cohort.

1. Participants had neuropathy that was induced by the chemotherapy between 1st January 2018 and 31st December 2021, regardless of the presence of pain symptoms;
2. Participants received at least one targeted medication between 1st January 2018 and 31st December 2021;
3. Participants were ≥18 years on the index date;
4. Participants had at least one medical visit record within12 months after the index date

Participants who meet any one of the following criteria will be excluded from the CIPN cohort.

1. Participants were diagnosed with epilepsy, schizophrenia, or bipolar disorder before or on the index date;
2. Participants had neuralgia or neuropathy caused by tumor metastasis or non-chemotherapy-induced factors (e.g., radiotherapy, myasthenia gravis syndrome, paraneoplastic syndrome, direct tumor invasion, local tissue compression, postoperative traumatic pain, immune therapy-related pain, comorbidity-induced pain, etc.)
Subjective Effects of Nitrous Oxide in Dental Patients - 17

The purpose of this study was to characterize mood changes during nitrous oxide inhalation in patients with different levels of preoperative dental anxiety.


Eligibility Criteria:
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Low Rectal Cancer Study (MERCURY II)

The MERCURY Study demonstrated the accuracy, feasibility and reproducibility of Magnetic Resonance Imaging (MRI) to stage rectal cancer in a prospective, multidisciplinary, multi-centre study. However, there were differences in patient outcome, dependent upon the position of the tumour in the rectum and its height above the anal verge. Whilst the outcome was excellent for patients who underwent an anterior resection, the outcome, based upon margin involvement and quality of the specimen, was poor for patients who underwent an abdomino-perineal excision for low rectal cancer.

It is proposed that accurate MRI staging pre-operatively will allow the correct patients to receive neo-adjuvant chemoradiotherapy (CRT), and also pre-warn the surgeons if the resection margins appear threatened so that the operation can be modified to take this into account. The primary aims of the Low Rectal Cancer Study (MERCURY II) are to assess the rate of CRM positivity rate in low rectal cancer and to assess the difference in global quality of life at two years post surgery in patients according to plane of surgery with or without sphincter preservation.

The aim of this study is to reduce the positive margin rate of 30% to around 15%. The study is an international multicentre, prospective, observational study, whereby patients with biopsy-proven low-rectal cancer (lower edge of the tumour \< 6cms from the anal verge on MRI), will be recruited from participating centres, having given informed, written consent. Data from the radiology, surgical and pathological aspects will be collected and analysed centrally at the Royal Marsden Hospital. The patient's medical records will be reviewed for five years post surgery, and the patients will also be followed up by quality of life questionnaires. This project aims to show that in low rectal cancer, improved local control and survival can be achieved through a reduction in the involved CRM rates by MRI-planned surgery and selective pre-operative therapy. It also aims to assess the ability to predict disease recurrence and to provide an assessment of disease-free survival and overall survival.

Eligibility Criteria:
Inclusion Criteria:

* Ability to give informed, written consent.
* Adults age 18 or over - male or female.
* Recently diagnosed with biopsy-proven, primary, low rectal cancer.
* No previous therapy for rectal cancer.

Exclusion Criteria:

* Current pregnancy, including ectopic pregnancy.
* Previous pelvic/rectal malignancy (excluding carcinoma in-situ).
* Previous pelvic radiotherapy.
* Previous pelvic floor surgery for faecal incontinence or prolapse.
Corneal Epitheliotropic Factors in Autologous Serum Eye Drops in Nonautoimmune and Stevens-Johnson Syndrome With Dry Eye

Autologous serum eye drops (ASE) have been becoming popular in treatment of severe dry eye for the past decade. One of the most beneficial properties of the ASE over artificial eye drops is the epitheliotropic capacity owing to the presence of growth factors and other proteins. There have been reports on alteration of serum growth factors in autoimmune diseases such as rheumatoid arthritis. Alteration in serum growth factors may lead to different therapeutic effect of ASE. We therefore would like to know if there are any alteration growth factors, epidermal growth factor (EGF), transforming growth factor-beta1 (TGF-β1), transforming growth factor-beta2 (TGF-β2), and fibronectin, in ASE from Stevens-Johnson syndrome (SJS) patients with dry eye, which constitutes a major group of ASE usage in Siriraj Hospital, as compared with non-autoimmune dry eye. We also study stability of these factors following different storage conditions.

Ten SJS patients with dry eye and 10 non-autoimmune dry eye patients are recruited in this study. Twenty to forty mL of peripheral venous blood is drawn and the serum is separated. The serum is diluted with Balanced Salt Solution (BSS) to provide 20% ASE. The levels of EFG, TGF-β1, TGF-β2, and fibronectin in 20% ASE are quantitated by enzyme-linked immunosorbent assay (ELISA) method and are compared between the two groups of samples. To study the stability of these serum factors under storage conditions used in clinical settings, 20% ASE are stored at different temperature and time i.e., at 4 ํC for 1 week and 1 month, and at -20 ํC for 1, 3 and 6 month. Their levels are then measured following each storage condition.

Eligibility Criteria:
Inclusion Criteria:

SJS group

* Patients diagnosed with SJS with dry eye syndrome
* Age more than 18 years old

Control group

* Patients diagnosed with dry eye syndrome
* Age more than 18 years old

Dry eye syndrome is defined as the having at least one symptom and one sign as the following:

Symptoms

1. Dryness sensation in the eye
2. Sandiness sensation in the eye
3. Burning sensation in the eye
4. Redness of the eye
5. Eye irritation
6. Eye stuck shut in the morning

Signs

1. Meibomian gland dysfunction
2. Tear film break-up time (TFBUT) \< 10 sec
3. Fluorescein staining at cornea
4. Schirmer test without anesthesia score ≤ 5 mm / 5 min
5. Ocular surface problems

Exclusion Criteria:

* Taking immunosuppressive drugs
* Acquired immunodeficiency syndrome (AIDS) patients or other immunodeficiency conditions
* Having autoimmune disorders (except for SJS in case group)
* Having systemic underlying diseases such as uncontrolled diabetes mellitus (DM), chronic kidney disease, liver cirrhosis, or systemic infection
* Pregnant women
Association Between Asthma and Food Allergy

Prevalences of food allergies and asthma increased in the population during the last decades. These two pathologies, responsible for a real burden, are often associated and are to be considered as comorbidities; this aspect is more and more studied in the literature and many authors tried to find a link between diets and asthma. The narrow link between these two atopic pathologies and the fact that food allergy can come along with respiratory symptoms also in patients without history of asthma must be better understood, considered into the management of food allergy. The main objective of this study is to study the prevalence of signs and/or symptoms suggestive of bronchial hyperreactivity, during an oral food challenge (OFC) in patients older than 5 years. The secondary objective is to study the risk factors to develop asthma during a food allergy reaction.

This historical-prospective single center study , was realized in the Allergy Unit of the University Hospital of Montpellier. All the patients having been hospitalized for a positive OFC between January, 2001 and January, 2016 were included. The diagnosis of asthma was established according to the recommended international clinical and physiological criteria. Prevalence of bronchial hyperreactivity during OFC among those with positive OFC, was calculated. The search for risk factors was made by a logistic regression univariate then multivariate, completed by a decision tree.


Eligibility Criteria:
Inclusion Criteria:

* Patient hospitalized for oral food challenge at the hospital

Exclusion Criteria:

* Patient want to leave the protocol
* Patient take medication forbidden during the study
Single Incision Laparoscopic Surgery (SILS) Versus Laparoscopic Cholecystectomy

Prospective randomized trial of single incision versus standard 4 port laparoscopic cholecystectomy. Hypothesis is that the operative time will be longer with single incision.

This will be a prospective, randomized clinical trial involving patients who present to the hospital with an indication for cholecystectomy. We will offer enrollment to several institutions provided they receive institutional approval.

This will be a definitive trial design. Based on our operative times with SILS compared with our recent experience in standard laparoscopy, a sample size of 60 patients will give us a power of 0.8 with an α of 0.05.

After the procedure, both groups will be managed in the same manner per routine care. They will be discharged when tolerating a regular diet and their pain is well-controlled on oral pain medication.

Eligibility Criteria:
Inclusion Criteria:

* Need for cholecystectomy

Exclusion Criteria:

* Need for cholangiogram
Pterygium Treatment Using Single Beta-therapy as Adjuvant Treatment Compared to Conjunctival Autograft

PURPOSE: To affirm the effectiveness and complication rate of postoperative single-dose beta-irradiation (RT) with (90) Sr in the case of primary pterygium in a clinical trial. METHODS AND MATERIALS: This trial was designed as a prospective, randomized, single center study. Surgery was performed in all cases according to the conjunctival autograft technique. One thousand and four patients with 108 pterygia were postoperatively randomized to either beta-RT or observation. In the case of beta-RT, a (90) Sr eye applicator was used to deliver 1000 cGy to the sclera surface at a dose rate of between 200 and 250 cGy/min. After treatment, both an ophthalmologist and a radiation oncologist performed the follow-up examinations. The accumulated data were analyzed using a group sequential test. RESULTS: Between February 2007 and September 2008, 104 eyes with primary pterygium were operated on according to the trial protocol. Additional treatment was performed within 24 hours postoperatively. Four patients were lost to follow-up, resulting in 104 patients who could be analyzed. In the 54 eyes randomized to receive beta-RT, 5 relapses occurred compared with 8 recurrences in the 50 eyes that no received RT, for a crude control rate of 90.7 % vs. 84 %, respectively. At a mean follow-up of 9 months (range 4- 18), major treatment complications had not been observed . CONCLUSION: Single-dose beta-RT of 1000cGy after conjunctival autograft surgery is a simple, effective, and safe treatment that reduces the risk of primary pterygium recurrence.


Eligibility Criteria:
Inclusion Criteria:

* Fresh pterygium without previous treatment.
* Adult patients with age higher than 18 years.

Exclusion Criteria:

* Diagnosis of glaucoma.
* Previous treatment of pterygium.
* Patients with age less than 18 years old.
Combination of Ertugliflozin And Sitagliptin Efficacy, Safety & Tolerability (CEASE Diabetes) Study

Open-label, prospective, observational, single arm, multi-center, post-marketing surveillance study to evaluate the efficacy, safety and tolerability of Ertugliflozin and Sitagliptin Con-initiation in patients with Type II Diabetes Mellitus in the Pakistani population. The study duration will be 12 months.


Eligibility Criteria:
Inclusion Criteria:

* Type 2 diabetic males \& females between 18-65 years.
* HbA1c: 7.0% - 10.0%
* Patient uncontrolled on oral anti-diabetics and lifestyle modifications for at least 3 months.
* eGFR \>60 mL/min/1.73m2.
* Patient who will give informed consent
* Patient who are SGLT2i naïve

Exclusion Criteria:

* History of severe hypoglycemia for the last three months (\<70mg/dL)
* Pregnant or lactating females
* History of renal and/or hepatic dysfunctions, where RFT and Urine R/E is abnormal
* History of recurrent urinary tract infection (UTI) and/or past 3 months' history of UTI and its treatment
* Patients who have been admitted to the hospital in the past 3 months for diabetic ketoacidosis (DKA) and hyperosmolar hyperglycemic state.
* History of acute coronary syndrome or myocardial infarction, unstable angina, arterial revascularization, stroke, transient ischemic attack.
* History of active liver disease, including chronic active hepatitis B or C, primary biliary cirrhosis, or symptomatic gallbladder disease
* Patient with diabetic foot ulcers
Sarcopenia and Orthostatic Hypotension

Elderly patients generally have a tendency for having sarcopenia which refers to muscle loss that may be related to many factors. These patients also have a tendency to falls and injuries. Whether elderly sarcopenic patients have abrupt blood pressure drops upon standing remains unknown. Therefore, in this study, we sought to determine the incidence of orthostatic hypotension in sarcopenic elderly patients and compare it with elderly patients with no sarcopenia.


Eligibility Criteria:
Inclusion Criteria:

* Patients 75 years or older

Exclusion Criteria:

* Pace-maker
* End stage renal insufficiency
* End stage malignancy
* Dehydration
* Severe anemia ( Hgb \< 8 gr/dl)
* Acute infection
* Marked edema
* Neurodegenerative disease
Procedures of Locoregional Analgesia and Quality of Life in Palliative Care Units

Number of patients in mobile palliative care units have pain of both nociceptive and neuropathic origin. In certain cases, procedures of locoregional analgesia can be helpful.

The Purpose of this study is to evaluate the impact of techniques of locoregional analgesia in a palliative population

Cancer pain is a serious problem in the palliative population. In particular, pain due to compression or invasion of nerve tissue by metastasis is frequent and often unresponsive to oral drug therapy and even to epidural administration of opioids. In such refractory pain in a palliative setting, one modality that could be helpful is the use of technics of locoregional analgesia. Currently, they are routinely used for the management of acute postoperative pain and become to be more widely used for cancer surgery. For example, intrapleural intercostal nerve blocks after major lung resection or preincisional paravertebral blocks after breast surgery have been shown to improve pain control. However, locoregional analgesia is only occasionally used in chronic cancer pain.

The procedures used are epidural analgesia, rachianesthesia, or continuous nerve blocks. L-bupivacaine will be used. The procedure will be performed only if the injection test is positive.

The patients will be evaluated before and after the procedure, the patient being his/her own control. Evaluations will take place immediately before the procedure, then at 48 hours, 1 week and 1 month after the procedure.

Eligibility Criteria:
Inclusion Criteria:

* Patient ≥ 18 years-old, male or female, whatever his/her ethnic group
* Patient with untreatable cancer
* Patient hospitalized in a palliative care unit, with a life expectancy ≥ 1 week
* Pain unresponsive to conventional treatments
* Effectiveness of the injection test
* Signed informed consent

Exclusion Criteria:

* Patients \> 18 years-old
* Patients with pain other than cancer pain
* Patient's refusal
* Coagulation disorders
* Local infection
* Known hypersensitivity to local analgesics
* Inefficacy of the injection test.
* Contraindication for analgesics