cyrilzakka/clinical-trials huggingface dataset:
Weight Gain After Smoking Cessation and NAFLD

Nonalcoholic fatty liver disease (NAFLD) is rapidly becoming the most common chronic liver disease. Considering that there are no approved pharmacological treatments, lifestyle modification is necessary and challenging to reduce the risk of type 2 diabetes mellitus (T2DM) in patients with NAFLD.

Cigarette smoking has a significant negative impact on public health, causing more than 480,000 deaths each year. Smoking has been reported as a risk factor for NAFLD and might accelerate liver disease progression. Therefore, it is recommended that patients with NAFLD quit smoking. However, smoking cessation could be complicated by weight gain. Thus, it is important to assess the impact of weight change after smoking cessation on patients with NAFLD. Proper management of post-cessation weight could maximize its health benefits.

In this large-scale cohort study, the investigators aimed to assess the effects of smoking cessation and subsequent weight change on risks of incident T2DM in individuals with NAFLD.


Eligibility Criteria:
Inclusion Criteria:

(i) age\>=18 years.

Exclusion Criteria:

(i) with missing information on ultrasound, smoking status, and weight; (ii) with excess alcohol intake or history of chronic liver disease at baseline; (iii) female subjects.
Acute Exacerbation of COPD and Physical Activity - Preliminary Study

People with chronic obstructive pulmonary disease (COPD) are very sedentary and efforts to establish an active lifestyle are challenging because of periodic acute exacerbations of COPD that interrupt physical activity patterns and contribute to further decline in physical activity. The purpose of this preliminary research is to learn more about the experience of acute exacerbations of COPD (AECOPD) from the perspective of the patient and his/her family and to learn how AECOPDs affect physical activity.

Individuals with chronic obstructive pulmonary disease (COPD) are very sedentary and their physical activity is often interrupted by acute exacerbations of COPD (AECOPD). Little is known about the expectations had by individuals with COPD and the effects of these expectations on their physical activity. To increase the understanding of these expectations in people with COPD, a study is proposed to explore their experience of daily fluctuations in symptoms and AECOPDs, focusing on how these experiences influence health promoting behaviors, especially physical activity (PA).

This study will involve an enrollment visit during which consent will be obtained, survey data will be administered (that they may take home), spirometry testing will be conducted, and a physical activity monitor (ActivPAL device) will be applied to be worn one week to allow us to understand their usual PA. A clinical ethnographic interview will then be conducted one week following enrollment, at which point the questionnaires and ActivPAL device will be collected. A second clinical ethnographic interview will be conducted one week following the first. Survey data will again collected at week 15 by mail.

Eligibility Criteria:
Inclusion Criteria:

* People who have emphysema or chronic bronchitis as their primary health problem
* People who have had a respiratory infection or an exacerbation of their COPD within the last year.
* People who are 55 years or older
* Family member of someone who meets the above criteria.

Exclusion Criteria:

* Other lung diseases as their primary pulmonary problem.
* Mobility problems that limit physical activity
Metabolic Activation With Protein-rich Formula Diet

Formerly, the investigators demonstrated in an uncontrolled proof-of principle study (NCT 01680926) that protein-rich meal replacement (PRMR) was successful in reducing daily insulin demand, HbA1c and weight in type 2 diabetes mellitus (T2DM) patients injecting \>100 IE insulin/day. The aim of the present study was to investigate in a randomized-controlled trial if PRMR is also effective in T2DM patients treated with oral antidiabetic medication or insulin.

A second part of the study is an open-label registry for persons with type 2 diabetes, who will perform the lifestyle intervention with the stringent diet regime.

Type 2 diabetes mellitus (T2DM) patients had been randomized into two groups. During the 1st week the intervention group with stringent diet regime replaced 3 main meals by 50 g PRMR (Almased-Vitalkost, Almased Wellness GmbH, Bienenbüttel, Germany) each (=1100 kcal/day). In 2nd-4th week 2 meals were replaced and a protein-rich lunch was allowed. In 5th-12th week only dinner was replaced. The control group with moderate diet regime replaced breakfast and dinner for 4 weeks and then only dinner during the next 8 weeks. Clinical parameters were determined at the study center at baseline, after 4, 8 and 12 weeks. Primary endpoint was reduction of HbA1c, secondary endpoints reduction of weight and antidiabetic medication.

In the second part of the study type 2 diabetes patients are included in an open-label reistry and perform the lifestyle intervention with the stringent diet regime.

Eligibility Criteria:
Inclusion Criteria:

* Type 2 diabetes mellitus
* HbA1c \> 7,5%
* Body Mass Index (BMI) ≥ 27,5 kg/m2

Exclusion Criteria:

* acute infections
* severe diseased with hospital stay during the last 3 months
* chronic diseases
* chemotherapy or cortisone treatment
* weight loss of more than 2 kg per week during the last month
* smoking cessation during the last 3 months or planned
* weight-influencing medication
* pregnancy, breast-feeding or lack of contraception
* high-level physical activity of more than 1h per day
* incompatibility with components of the PRMR
* participation in an other study during the last 6 months

For the open-label registry, the only inclusion criterium is type 2 diabetes.
The Influence of a "Cooling Ice Spray " Application on the Time to Stability After a Forward Jump?

The aim of this study is to investigate the influence of a brief application of cold (by means of Cooling Ice Spray on the lateral ankle)on the time to stabilization of healthy subjects.

In sports are "Cooling Ice Spray" applications after an injuries one of the most common and popular methods used. It is very popular mainly because of its analgesic effect and easy application. It is assumed that such application will not affect the athletes. Nevertheless after an application of cold a reduced nerve conduction velocity was measured, resulting in a reduction in pain and a reduced transmission rate. Usually the static equilibrium or the perception of joint position was investigated and not the time to stability. As far as we have been known so far been no study that has examined the impact of a brief application of cooling ice spray on the time to stability after dynamic function. Therefore this study what's to investigate the influence of "Cooling Ice Spray" on the time to stability after a forward jump.

Eligibility Criteria:
Inclusion Criteria:

* healthy adults
* 18-45 age
* \>3 Score "Tegner-Activity-Scale"

Exclusion Criteria:

* Cognitive deficits
* Physical disability
* Pain
* Injuries in the previous 6 weeks
* Non healed injuries at the leg
* Allergic reaction from cooling ice pray
Safety Study of Keyhole Gallbladder Surgery With Removal of Gallbladder Via the Stomach Rather Than Through the Skin

The benefits of laparoscopic ("minimally invasive" or "keyhole") surgery for gallbladder removal (cholecystectomy) over open surgical procedures in terms of significant reductions in pain, scarring and recovery time are well accepted. In a conventional laparoscopic cholecystectomy however, the excised gallbladder still has to be extracted through the abdominal wall skin via a laparoscopic port site using an incision of 10mm or greater. Despite being much smaller than that required for open surgery, this incision is painful, leaves a scar and can result in a port site hernia to follow requiring further surgery to repair it. Recent attempts to further reduce the invasiveness of the surgical procedure have suggested performing the operation via an endoscope passed through the mouth and through an incision in the stomach wall - so called Natural Orifice Translumenal Endoscopic Surgery (NOTES). Unlike a skin incision, an incision in the wall of the stomach (gastrotomy) should give no pain, visible scar or herniation risk yet still allow access to the peritoneal cavity for surgical procedures such as cholecystectomy. Against this, it has the potential risks of contamination and leakage of gastric contents into the peritoneal cavity. Whilst the limitations of present technology make it very difficult to perform an entire cholecystectomy through the stomach wall in patients, endoscopic methods for closing a gastrotomy are available that are approved for use in patients (CE marked) and it is hypothesised that removing the excised gallbladder through the stomach in this way would avoid the problems of extracting it through the abdominal wall described above. Data are required to determine whether the extraction of the gallbladder via a gastrotomy rather than through the skin is safe, producing smaller scars and a better cosmetic result. A secondary endpoint would be to assess possible reductions in pain and recovery from this less invasive approach.


Eligibility Criteria:
Inclusion Criteria:

* Fit patients, avoiding extremes of age, with uncomplicated gallstone disease requiring elective laparoscopic cholecystectomy.

Exclusion Criteria:

* Direct healthcare team deny permission to approach patient for trial.
* Patient request / preference.
* Age (\< 21 or \> 65 yrs old).
* Co-morbidity (ASA level 3 or above).
* BMI \> 32.
* Complicated gallstone disease (eg bile duct stones/ERCP/pancreatitis).
* Gallstones ≥ 18 mm size (too large to recover via oesophagus).
* Pregnancy.
* Previous gastric or upper abdominal surgery (alterations in gastric anatomy or adhesions preventing safe gastrotomy).
* Emergency procedure.
* Planned other operation during cholecystectomy.
* Inability to consent or psychiatric or addiction problems relevant to surgery.
Evaluation of Visual Acuity in Myopic Cataract Patients Using Trifocal Intraocular Lens

The PanOptix trifocal IOL is a new trifocal intraocular lens which is proved to provide good range of vision for distance, intermediate and near and good visual quality in cataract patients with normal axial length. But whether it can get the same visual quality in myopia is still unknown

There are a few publications of multi-focal IOLs on Chinese patients with high myopia. From published papers, it is known that performance of multifocal IOLs is satisfied in myopic patients. However there is no publication to investigate PanOptix in moderate and high myopic patients. So it is imperative to demonstrate good performance of PanOptix in those special patients. The purpose of this study is to assess visual performance and patient satisfaction after the implantation of PanOptix in myopic patients.

Eligibility Criteria:
Inclusion Criteria:

1. Axial myopic patients（Refractive condition match the axial length after eliminate the nuclear cataract induced myopia factor）
2. Corneal astigmatism \<1.0D (IOL-Master 500/700, Carl Zeiss Meditec, Jena, Germany);
3. Eyes with pupil diameter\>2.5 mm (Photopic) and\<6 mm (Mesopic) (Pentacam HR, Oculus Optikgerate GmbH);
4. Eyes with angle kappa\<0.50 mm (Pentacam HR);
5. Eyes with corneal spherical aberration\<0.50 (Pentacam HR)

Exclusion Criteria:

1. Irregular corneal astigmatism
2. Any retinal disease, macular disease(Including myopic MD and retinal diseases) could affect VA, glaucoma and other severe intraocular diseases
3. Moderate-severe dry eye
4. Amblyopia（BCDVA\<0.7 before cataract appears）
5. Patients having difficulties with examinations or 3 months' follow-up.
Assessment of Biomarker Profile in Diabetic Macular Edema With Intravitreal Aflibercept Injection

To assess the biomarker profile in diabetic macular edema patients in response to intravitreal aflibercept injection. Patients with diabetic macular edema who meet study requirements will receive monthly intravitreal injections of aflibercept as approved by FDA for a period of 6 months. A small quantity of fluid will be removed from the vitreous at each injection for laboratory evaluation of biomarkers present before, during and after treatment with aflibercept.

Study objective is to better understand the pathophysiology of diabetic macular edema (DME) by defining the factors that participate in the disease process or may be good biomarkers for disease progression. Study will investigate the temporal relationship between the course of treatment with anti-VEGF therapy and levels of candidate biomarkers previously identified to determine which biomarkers are affected by anti-VEGF therapy with aflibercept. Study will correlate response to therapy to particular biomarkers and attempt to identify those associated with resistance to therapy for DME. Biomarker data will be correlated with serial clinical evaluation of disease progression. 40 subjects with clinically significant DME who plan to undergo anti-VEGF therapy will be treated with intravitreal aflibercept monthly for 6 months. At each visit aqueous humor will be collected and stored (6 samples per patient). At termination of study all specimens will be analyzed for biomarkers identified from previous studies.

Eligibility Criteria:
Inclusion Criteria:

* Current diagnosis type 1 or type 2 diabetes
* Clinical DME as assessed by OCT
* Well controlled glaucoma on medications but not on prostaglandin analogues
* Mild Age Related Macular Degeneration (AMD)
* Visual acuity between 73 and 5 ETDRS letters (20/40 -20/800 on eye chart)
* Willing and able to participate and to comply with clinic visits and procedures
* Provide signed informed consent

Exclusion Criteria:

* Unwillingness to participate or inability to understand or sign informed consent
* Poor eye fluid that would preclude adequate testing
* Prior intraocular treatment with anti-VEGF or focal laser treatment within 90 days
* Corticosteroid injections within 120 days
* Active proliferative diabetic retinopathy
* Intraocular pressure greater than 25 mm Hg
* Any previous vitrectomy surgery
* Current use of systemic anti-VEGF agents
* Shallow anterior eye chamber in eye with natural lens
* Non-diabetic related macular swelling (retinal vein occlusion)
* History of ocular disease
* Systemic disease other than diabetes mellitus
* Pregnant or breast feeding women
* Sexually active men or women of childbearing potential who are unwilling to practice adequate birth control during study
tDCS Stimulation to Treat Patients With Severe and Resistant Obsessive Compulsive Disorder-Pilot Study

The purpose is to show that bifocal tDCS with an anodal stimulation on the orbitofrontal cortex and cathodic stimulation on supplementary motor areas is an effective treatment for patients with resistant and severe obsessive compulsive disorders.


Eligibility Criteria:
Patients must present all of the following criteria in order to be eligible:

Inclusion Criteria:

* Meets criteria for obsessive compulsive disorder according to DSM-IV with a "good insight" (BABS),
* Age: Participants will be both males and females, 18-70 years of age included.
* No current depressive and suicidal risks,
* No epileptic pathology,
* Chronic evolution ( Total Y-BOCS\>20 ),
* Obsessive compulsive disorder resistant to pharmacology treatment, at least 2 antidepressants (type IRS) or cognitive and comportment therapy since at least one year,
* Stability treatment (antidepressants) for more than 12 weeks without significant improvement,
* Affiliation to a social security system (recipient or assignee),
* Signed written inform consent form.

Exclusion Criteria:

* Female subject who is pregnant, or of child-bearing age, sexually active and not using reliable contraception or who is nursing,
* Patient under curators
* Meets another diagnosis of axe 1 of DSM-IV,
* Current depressive or suicidal risks,
* Patient with a benzodiazepine treatment,
* Patient with any form of metal in the cranium, a pacemaker, skull defects, or skin lesions to the scalp (cuts, abrasions, rash) ,
* Epileptic patient,
* Patient with a medical history of cranial trauma,
* Patient unable to give his or hers informed consent.
Validity and Reliability of the Turkish Version of the Sydney Swallow Questionnaire

Purpose of the study is the validity and reliability of the Turkish version of the Sydney Swallow Questionnaire (SSQ-T), so that it would be used as an assessment tool for Turkish dysphagia patients. Despite being translated and validated in many languages, there is no validated Turkish version of SSQ to measure the severity of oropharyngeal dysphagia.

The swallow function is a multidirectional process that depends on complex neuro-muscular network. The function can be evaluated using instrumental, such as fibreoptic endoscopic evaluation of swallowing (FEES), videofluoroscopy, or well structured questionnaires. There are many questionnaire and scales for assessment of swallow but very few have been validated. The study will assess the construct validity and reliability of the Turkish version of Self-report Symptom Inventory as known as Sydney Swallow Questionnaire. The investigators developed the Turkish version of this questionnaire (SSQ-T), according to the cross-cultural adaptation guidelines. Two translators translated the SSQ into Turkish and a native English language speaker reverse-translated it into English. The back translation was sent to the original author for proofreading. The SSQ questionnaire consisted of 17 basic questions related with dysphagia symptoms.

Eligibility Criteria:
Inclusion Criteria:

Group 1:

* Able to speak, read, understand and write in Turkish
* History of dysphagia during 6 months
* Age between 18-80 years

Group 2:

* Able to speak, read, understand and write in Turkish
* Healthy adults
* Age between 18-80 years old.

Exclusion Criteria:

* Mental disorders
* Cognitive limitations
* Able not to speak, read, understand and write in Turkish
* Underwent any surgery last a month
* Underwent laryngectomy/neck dissection/tracheostomy/neck radiotherapy
* Pregnancy
* Malignancies
* Out of age 18-80 years old.
Secondary Prevention of Venous Thrombo Embolism (VTE).

The general aim of this study is to determine the comparative safety and efficacy of dabigatran etexilate administered orally and warfarin (International Normalized Ratio (INR) of 2.0-3.0) for the long-term treatment and secondary prevention of symptomatic venous thromboembolism in patients who have been successfully treated with standard doses of an approved anticoagulant for three to twelve months for confirmed acute symptomatic Venous Thrombo-embolism.


Eligibility Criteria:
Inclusion criteria:

Inclusion_Criteria

* Acute symptomatic deep vein thrombosis (DVT)
* Pulmonary embolism (PE) 3-12 months prior to screening, which has been documented by objective testing

Exclusion criteria:

Exclusion_Criteria

* Symptomatic DVT or PE at screening Interruption of anticoagulant therapy for 2 or more weeks during the 3-12 months of treatment for the prior VTE.
* Patients who in the investigators judgement are perceived as having an excessive risk of bleeding Elevated Aspartate aminotransferase (AST) or Alanine tranminase (ALT) \> 2x ULN
* Severe renal impairment (estimated creatinine clearance \<= 30 ml/min)
Contribution of ICG Angiography in the Detection of Parathyroids and the Prevention of Hypoparathyroidism Post Total Thyroidectomy

* Hypoparathyroidism is the most common complication after a total thyroidectomy surgery. It becomes permanent after 6 months.
* Untreated permanent hypoparathyroidism is a source of numerous complications in general and therefore requires lifelong replacement therapy resulting in a significant deterioration in quality of life.
* The intraoperative use of indocyanine green (ICG) angiography has recently been described as a reliable means of detecting parathyroidism and predicting the risk of postoperative hypoparathyroidism.
* This use could prove to be a way to preserve parathyroid in vivo and thus reduce post-operative hypoparathyroidism rates.

Hypoparathyroidism is the most common complication after a total thyroidectomy surgery. It is most often transient but can sometimes be permanent when it persists for more than 6 months after surgery. The rates are variable, of the order of 32% for transient hypoparathyroidism and 1% for definitive hypoparathyroidism. Untreated permanent hypoparathyroidism is the source of many complications in general and therefore requires lifelong replacement therapy. The result is a significant deterioration in quality of life.

The mechanisms responsible for hypoparathyroidism during thyroidectomy are direct damage to the parathyroid glands, involuntary excision of these glands, and devascularization of these glands.

The detection of parathyroid glands and the prevention of hypoparathyroidism after thyroidectomy therefore represents a major challenge.

The intraoperative use of indocyanine green angiography has recently been described as a reliable means of detecting parathyroid and predicting the risk of postoperative hypoparathyroidism.

In addition, prior studies and intraoperative observations suggest that indocyanine green angiography during thyroid surgery may be a means of preserving parathyroid in vivo and thus reducing post-operative hypoparathyroidism rates.

Eligibility Criteria:
Inclusion Criteria:

* Patient having to undergo a total thyroidectomy
* Signed consent
* Patient beneficiary of a social security regimen

Exclusion Criteria:

* Minor patient under 18 years old
* Major patient protected by law or unable to give informed consent
* Pregnant or breastfeeding woman
* Thyroidectomy totalization
* History of thyroid or parathyroid surgery
* Participation refusal
* Known allergy to ICG
* Woman of child-bearing age not using adequate method of contraception
Mesalazine Oral Suspension in Active Eosinophilic Esophagitis

Pilot study to assess a mesalazine oral suspension in active eosinophilic esophagitis

This is an open-label, monocentric exploratory phase IIa pilot study, which serves to evaluate the efficacy, safety, and tolerability of treatment with mesalazine oral suspension for the treatment of active eosinophilic esophagitis (EoE).

Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent
* Male or female patients, 18 to 75 years of age
* Confirmed clinico-pathological diagnosis of eosinophilic esophagitis (EoE) according to established diagnostic criteria
* Negative pregnancy test in females of childbearing potential

Exclusion Criteria:

* Other causes for esophageal eosinophilia
* Clinical and endoscopic signs of gastroesophageal reflux disease (GERD)
* Any concomitant esophageal disease and relevant gastro-intestinal disease (celiac disease, inflammatory bowel disease, oropharyngeal or esophageal bacterial, viral, or fungal infection \[candida esophagitis\])
* Any known or suspicion for relevant infectious diseases associated with clinical signs,
* Known intolerance/hypersensitivity/resistance to the IMP or excipients or drugs of similar chemical structure or pharmacological profile
* Existing or intended pregnancy or breast-feeding