cyrilzakka/clinical-trials huggingface dataset:
Reduced Ability to Make Decisions: a Study That Observe Differences in Patients With Fibromyalgia and Healthy Control

The literature has identified impairments in various cognitive functions, including learning, memory, attention, psychomotor speed, executive function, and working memory. However, only a few studies to date have investigated impairment in the decision-making process.

The aim of this study is to evaluate decision-making skills in a group of patients with fibromyalgia and compare these results with a group of healthy controls. Specifically, investigators will evaluate four hypotheses:

1. Patients with fibromyalgia may show disadvantageous decision-making in contexts of emotional decision-making and may persevere more in their wrong choices. For this reason, investigators hypothesize that patients with fibromyalgia will more frequently choose the disadvantageous decks than the healthy control group in the Iowa Gambling Task.
2. Secondly, investigators hypothesize that patients with fibromyalgia need more time to make their choice. Consistent with this hypothesis, researchers expect to find significant differences in the average time taken by the participant to make a choice in the Iowa Gambling Task.
3. The third hypothesis is that patients with fibromyalgia may have greater difficulty inhibiting automatic responses, which may lead to longer reaction times in the Stroop task. Investigators also hypothesize that stimuli with negative emotional valence (related to the typical pain experience in fibromyalgia) may have a greater effect on patients with fibromyalgia than on healthy controls (longer reaction time in the emotional Stroop Task compared to healthy controls).
4. Finally, investigators hypothesize that anxiety, depression, sleep quality, pain, decision-making style and social support may be related to worse performance in ability-based tasks.


Eligibility Criteria:
Inclusion Criteria:

* Fibromyalgia syndrome (confirmed by a medical diagnosis);
* Able to understand English, Dutch or French;
* Signed an informed consent.

Exclusion Criteria:

* Other diagnoses (osteoarthritis, rheumatoid arthritis, post-cancer pain, as well as patients with primary psychiatric/neurological conditions or psychopathological disorders);
* History of substance abuse or pathological gambling;
* Color blindness;
* Not have pain currently or have a recent history of pain (ONLY FOR HEALTY CONTROL GROUP).
Videothoracoscopic (VATS) vs. Robotic Approach for Lobectomy or Anatomical Segmentectomy

This is a prospective, randomized, multicenter study on 300 patients (150 VATS lobectomies and 150 robotic lobectomies) affected by early stage (I-II) lung cancer. The expected recruitment is one year and two year follow up. Surgeons should have a minimum of 30 major lung resections performed using one of the two techniques for participation in the study. Each participating centers should have the possibility to offer both techniques (Robotics and Vats). The primary end point is a combination of conversion and complication rate. The presence of at least one of the two events is considered a failure. Considering the rate of failure of 35% in the VATS arm, we want to see a failure rate not over 20% in the robot arm, so with a power of 80% and an alpha error of 5%, we need a total of 300 patients.


Eligibility Criteria:
Inclusion Criteria:

* Age older than 18 years old
* Known or suspected lung cancers
* Patients in clinical stage T1-T2, N0-N1 candidate to surgery lobectomy or anatomical segmentectomy
* ASA-1-2-3

Exclusion Criteria:

* Clinical stage \>II
* Severe heart disease
* Alcohol abuse
* Renal impairment (creatinine \>2.5)
* Presence of serious comorbidities
Comparative Volumetric Assessment of Alveolar Ridge Preservation Utilizing Different Bone Grafting Materials

This study is intended to provide statistically robust evidence that Symbios Demineralized Cortical-cancellous granule mix, Symbios OsteoGraf LD-300, and OsteoGraf/N-300 combined with Symbios OsteoShield Collagen Resorbable Membrane can adequately support the alveolus during ridge augmentation procedures, reducing the dimensional changes of both the alveolus and the overlying soft tissues. Additionally, a comparison between each material will be made, providing further evidence of each materials' ability to preserve the alveolus. It is intended to define in objective terms the response of the hard and soft tissues to ridge augmentation.


Eligibility Criteria:
Inclusion Criteria:

1. Provision of informed consent
2. ≥ 18 years and ≤ 75 years
3. Good physical health (ASAI/II)
4. Extraction of maxillary premolar, canine or incisor, or mandibular premolar and canine required
5. Teeth adjacent (mesial and distal) to study site must consist of two stable natural teeth with minimal restorations, without signs of periodontal bone loss (\> 3 mm) and/or significant soft tissue deficiencies

Exclusion Criteria:

1. Buccal plate dehiscence and/or fenestration \>3mm at study site following extraction
2. Untreated rampant caries and uncontrolled periodontal disease
3. Inadequate oral hygiene (estimated plaque score \>20%)
4. Smokers using more than 10 cigarettes or equivalent per day
5. Smokeless tobacco use or e-cigarette use
6. Compromised physical health and/or uncontrolled or severe systemic diseases including:

   ASA III/IV Metabolic bone disease History of malignancy History or radiotherapy or chemotherapy for malignancy in the past 5 years History of autoimmune disease Long-term steroidal or antibiotic therapy Uncontrolled diabetes Known alcohol or drug abuse
7. Systemic or local disease or condition that would compromise post-operative healing
8. Use of any substance or medication that will influence bone metabolism
9. Known pregnancy
10. Unable or unwilling to return for follow-up visits for a period of 6 months
11. Unlikely to be able to comply with study procedures according to Investigators judgement
12. Involvement in the planning and conduct of the study
13. Previous enrollment or randomization of treatment in the present study
Treatment of Binge Eating Disorder

This is a study examining the use of different degrees of therapist involvement in the treatment of Binge Eating Disorder. The study will examine both which approaches work best for decreasing symptoms and which are most cost-effective.


Eligibility Criteria:
* Binge Eating Disorder
* Age 18-65, Male or Female
* Not Currently receiving psychotherapy
* Not currently in Formal weight loss treatment
* No current unstable medical problems
* No history of Bipolar illness or Schizophrenia
* Overweight or Obese (body mass index 25-45)
Peripheral Analgesia in Painful Diabetic Neuropathy

Chronic obliterative arteriopathy of the inferior limbs is a frequent condition observed in diabetics. The later stages induce pain at rest and trophic disorders (ulcer, gangrene) that lead to chronic limb ischemia. Without possible surgical revascularization ,pain management and tissue healing are used to avoid amputation.

Prevalence of diabetes is twice higher in Reunion Island than in metropolitan France. As a consequence, the rate co-morbobidities, such as chronic obliterative arteriopathy of the inferior limbs, is also increases.

This study compares the efficiency of two analgesic treatments in diabetics with forefoot injuries.

Patients are allocated in two groups regarding :

* their eligibility to analgesic treatment using continuous peripheral nerve blocks
* the unability of usual pain management to reduce their pain (pain visual analogic scale equal to or more than 4).

When patient 's response to pharmacological analgesic treatment is sufficient (pain visual analogic scale equal to or less than 3), patient is allocated to the control group.

Patients of experimental group received a continous analgesic treatment for 6 weeks using ropivacaine (2mg/ml, flow rate 7 ml/h).

Patients of control group received an analgesic treatment according the recommended pain ladder of World Health Organization (WHO). Opioids for mild-to-moderate pain are used in combination with a non-opioid analgesic, such as paracetamol, at the second step of the ladder. If regular maximum doses of opioids for mild-to-moderate pain do not achieve adequate analgesia, then they should be replaced with an opioid for moderate-to-severe pain, such as morphine.

Efficiency of both treatment is assessed the improvement of oxygen level in the tissue below the skin of the injured forefoot through the study.

Eligibility Criteria:
Inclusion Criteria:

* Hospitalized patient
* Diabetics with chronic obliterative arteriopathy of the inferior limbs
* Permanent limb ischaemia with a TcPO2 of the front-foot of at least 10 mmHg under atmospheric conditions
* Lack of surgical revascularization
* No contraindication to hyperbaric therapy
* Signed informed consent

Exclusion Criteria:

* Contraindication to ropivacaine
* Conditions that could alter hyperbaric measurements (anemia \< 8 g/dl, cardiac or respiratory insufficiency)
* patients with planned limb amputation
The Akloma Tinnitus Patch in Patients With Manifested Tinnitus

OBJECTIVES:

Primary Objective The primary objective will be a decrease of inconvenience with at least 10% for at least 50% of the subjects.

Secondary Objectives

The secondary objective will be to:

To evaluate if the patch can improve the tinnitus patient's quality of life and sleep quality.

METHODOLOGY

Study Design:

An open safety and performance clinical investigation of the antinitus patch in patients with manifested tinnitus.

Treatment Duration:

1 patch per day for 3 weeks

Primary Endpoint:

Tinnitus severity questionnaire (TSQ)

Performance Parameters:

Tinnitus severity questionnaire (TSQ) and numerical rating scale (NRS) measuring tinnitus annoyance.

Quality of life and sleep quality

Safety Parameters: Adverse Reactions


Eligibility Criteria:
Inclusion Criteria:

* Adults of both sexes \> 18 years of age
* Signed informed consent
* Patients who have suffered from tinnitus for ≥ 4 weeks before study entry
* Manifested tinnitus grade II or above on the Klockhoff-Lindblom tinnitus severity grading scale.
* Tinnitus score of 5 or above (numerical rating scale for tinnitus annoyance)
* Pure tone averages better than 40 dB in the worse hearing ear.

Exclusion Criteria:

* Pregnant or lactating women
* Malignancy or other serious medical conditions
* Skin disease
* Simultaneous or previous (within 30 days prior to study entry) participation in a clinical study using experimental drugs or devices.
* Severe psychiatric disorder
* Serious suicidal risk
* Patients who have started treatment or made changes in treatment with drugs known to influence tinnitus within 6 weeks before study start.
* Patients with untreated high blood pressure ≥140/90 mmHg
* Other tinnitus treatment within 6 weeks before study entry.
* Previous use of the Antinitus patch
* Known allergy or sensitivity to any of the compounds in the Antinitus or the placebo patches.
Use of Fish Oils to Reduce Recurrence of Atrial Fibrillation Following DC Cardioversion

The purpose of this study is to investigate whether fish oil supplements may be beneficial in preventing the recurrence of atrial fibrillation after cardioversion.

Atrial fibrillation is a heart condition which can sometimes be successfully treated by a cardioversion.

Cardioversion involves resetting the heart back to normal with the use of electric current.

There is a tendency for the atrial fibrillation to recur , days weeks or even months after the cardioversion.

Fish oil supplements may be of benefit to patients with heart problems Recent evidence suggests that fish oils may be beneficial to patients with rhythm disturbances.


Eligibility Criteria:
Inclusion Criteria:

* Patients with persistent Atrial Fibrillation on Warfarin.

Exclusion Criteria:

* paroxysmal atrial fibrillation with self terminating episodes.
* left atrial size\>6.0cm
* myocardial infarction in the previous 6 months.
* contraindications to amiodarone use .
* cardiac surgery in the previous 3 months .
* an acute reversible illness contributing to the development of af
* a QTc interval \> 480ms.
* pregnancy
Healthy Lifestyle or Pro-health Obsession During the Pandemic

Citizens of many countries are in the high peak period of the outbreak of the COVID-19 virus. People are currently struggling with the total cessation of certain aspects of normal life. The situation associated with the pandemic can lead to the development of many problems connected both with mental and physical health. The investigators, as psychologists, would like to better understand this difficult situation and identify mechanisms which can lead to health problems. Therefore, group of researchers and practitioners created this study to investigate how people in general cope with this critical situation. The researchers would like to estimate the following variables which participants will evaluate before and during the pandemic period: levels of physical activity, attitudes towards one's body, attitudes towards eating, and psychological well-being. The investigators would like to involve experts and scientists from all around the world. Through this research and by investigating how people cope with this critical situation the solutions for psychological care and interventions for global crisis situations like the COVID-19 pandemic might be identified.


Eligibility Criteria:
Inclusion Criteria:

- Age: min 18 years old

Exclusion Criteria:

- no
A Study To Investigate The Effect Of A Natural Dietary Supplement On Peri-Menopausal Symptoms

This is a randomized, masked, placebo controlled study to assess the effect on a nutritional dietary supplement on menopausal signs and symptoms in perimenopausal women.


Eligibility Criteria:
Inclusion Criteria:

* Age group between 45 and 65 at the time of informed consent.
* Physician diagnosis of menopause.
* History of substantial hot flashes \> 4 episodes /day for last 2 weeks.
* Being post-menopausal with an intact uterus.
* Subject has provided signed and dated written informed consent before admission to the study.

Exclusion Criteria:

* Concurrent hot flash therapies (prescription medications including hormone replacement therapies, gabapentin or over the counter supplements), vaginal hormonal products (rings, creams, gels) or transdermal estrogen or estrogen/progestin products for 30 days before screening visit.
* Women currently or previously on anticoagulants, Vitamin K antagonists like warfarin in the past 3 months, or expected to be on anticoagulants in the near future.
* Women involved in other clinical studies within the last 30 days.
* Any women who, in the opinion of the principal investigator, is at poor medical or psychiatric risk for the study.
Experimental Study About Physiotherapy Treatment vs Self-treatment In Axillary Web Syndrome After Axillary Dissection

BACKGROUND Dissection and removal of Lymph nodes in the Axilla (ALND) remains a method used in breast cancer management across the world. Post- surgical scar tissue that forms in this dissection is therefore beyond the linear scar, is characterized by less elasticity than healthy tissue and can over time, because of the anatomical location, cause significant limitations of the Active Range of Motion (AROM) of the scapulohumeral joint. After this procedure it's possible that Axillary Web Syndrome (AWS) occurs. This study discusses the physiotherapy management of patients with AWS. The primary objective of the study was to verify direct and indirect changes to AWS cords with two treatment methods at a single breast cancer rehabilitation setting: Physiotherapist 's work Vs. Self-treatment.

Breast cancer is the most common form of cancer among women. Axillary surgical procedures have reported, with post-operative morbidity of bleeding, lymphedema and shoulder pain, also the rather underestimated Axillary Web Syndrome. The study shows that the reduction of the problems linked to the Syndrome such as pain in shoulder Abduction and Flexion and inability in everyday life is possible with an early and competent treatment. Two different approaches to the Syndrome were investigated. The patients were divided in two groups. Good results were obtained within 5 weeks since the appearance of AWS with both of them but if the Physiotherapist is able to teach the convenient exercises, the selftreatment seemed to have the best outcome. This fact can change the awareness that an early approach is necessary inside the path to recovery. In the last years the Axillary Web Syndrome was the topic of many studies: the etiology, its clinical diagnosis, the relation with lymphedema...But the treatment was often reported like a combination of different techniques without indications about kinds, times. Instead the investigators examined a detailed procedure, the same in both groups. The work was different only as regards the cords treatment. This fact shows the value of a comprehensive treatment for neck, shoulder, breast and two different but specific works on the Axillary Web Syndrome. For these reasons its publishing could be important for all the professionals working with women after Surgery for breast cancer and metastatic lymphnodes.

Eligibility Criteria:
Inclusion Criteria:

1. Age \> 18years;
2. Patients able to sign informed consent;
3. Patients who underwent ALND surgery for breast cancer;
4. Presence of cords associated with A.W.S.;
5. Surgeon examination carried no more than 10 days after the operation.

Exclusion Criteria:

1. Presence of cords after AD due to Melanoma metastasis.
Effect of Dexamethasone Implant in Hard Exudate Complicated With Diabetic Macular Edema

A Single Arm, Single Dose Study to Evaluate the Effect of intravitreal dexamethasone implant (Ozurdex®) on hard exudates of diabetic macular edema.

Diabetic macular edema (DME) is important vision threatening complication of diabetes mellitus. Laser photocoagulation, vitrectomy, intravitreal steroid injection and intravitreal antiVEGF (anti vascular endothelial growth factor) injection are being used as treatment of DME. Sustained releasing intravitreal dexamethasone implant has been known to be effective in reducing the central retinal thickness and gain of vision for DME. Although hard exudate at macula is important pathology of DME, impact of intravitreal dexamethasone implant on hard exudate are not studied yet. Therefore the investigators designed the descriptive study to reveal the hard exudate change in DME eyes treated with intravitreal dexamethasone implant.

Eligibility Criteria:
Inclusion Criteria:

1. Patients diagnosed with CSME (clinically significant macular edema) with hard exudates within 1500 micrometer from foveal center
2. Those who have a BCVA (best corrected visual acuity) of study eye between 0.06(20/320) and 0.5(20/40)
3. Those who have a central macular thickness on OCT over 300 micrometer
4. If both eyes are eligible, eye having more hard exudates is selected (contralateral eye should be treated with corticosteroid other than Ozurdex or focal laser photocoagulation, anti-VEGF (vascular endothelial growth factor) injection is not allowed in contralateral eye)

Exclusion Criteria:

1. Those who have CSME without hard exudates
2. Those who have macular edema not related with diabetic retinopathy (e.g. AMD (age-related macular degeneration), uveitis, retinal vein occlusion and untreated malignant hypertension)
3. Those who have a history of Intraocular surgery (e.g. cataract surgery) within 3 months
4. Those who have a visual acuity of contralateral eye less than 0.1 (10/100)
5. Those who received focal laser treatment on macula within 3 months
6. Those who had intravitreal anti-VEGF agent injection within 3 months
7. Those who had intravitreal triamcinolone injection within 6 months
8. Those who have other ophthalmologic disease affecting visual acuity (e.g. central corneal opacity, cataract change at lens center)
9. Those who have severe systemic disease (e.g. uncontrolled DM, hypertension, cardiovascular disease, cerebrovascular disease)
10. Those who refuse to submit written consent
11. Those who cannot understand the contents of the clinical study and cooperate in the clinical trial
12. Those who are pregnant or lactating women
13. Those who have a history of vitrectomy
14. Those who require systemic corticosteroid or immunosuppressive agent treatment
15. Those who are banned from using Ozurdex

    * Ocular infection or periocular infection
    * Advanced glaucoma
    * Hypersensitivity to dexamethasone or other component of Ozurdex
    * Posterior lens capsule rupture or Aphakia
    * Anterior chamber intraocular lens or posterior capsule rupture
Infection Surveillance in Intensive Care Patients

Purpose of the study is to investigate and quantify known and possible new riskfactors for nosocomiel infection and death in the intensive care setting.

As new riskfactors Mannose Binding Lechtin and Procalcitonin are chosen and compared to established riskfactors.


Eligibility Criteria:
Inclusion Criteria:Admission to ICU -

Exclusion Criteria:Absence of informed consent and age less than 18 years

-
Urethral Stricture Database

Establishment of a clinical urethral stricture database for a prospective longitudinal cohort study.

The aim is to establish a prospective clinical database of patients undergoing urethral surgery due to urethral stricture. In addition to pre-operative basic data, intraoperative and postoperative data, as well as follow-up data through questionnaires, are to be collected. The main objective is the prospective determination of success rates of the performed urethral surgeries in the short, medium, and long term. Furthermore, risk factors leading to failure (recurrence of urethral stricture) should be identified. Ultimately, the quality of life before and after urethral surgery is to be assessed in order to compare the applied procedures.

In today's reconstructive urethral surgery, there are few scientific surveys so far. Many of the applied techniques (therapy options) are based more on the experiences of individual surgeons than on a solid database, hence there are also different approaches. By evaluating prospective data and comparing individually applied surgical methods, the least complication-prone and most successful techniques are to be identified. The planned study aims to create an "efficacy-safety" profile for each urethral surgery technique. This will enable us in the future to not only provide improved (data-based) patient information but also to involve the patient better in the therapy decision. Thus, in the future, counseling and therapy for a young sexually active patient could differ from counseling for an older patient who is no longer sexually active, even with the same stricture length and location.

The analyses of the urethral database will thus enable us to internally validate therapy algorithms and provide personalized patient counseling.

Eligibility Criteria:
Inclusion Criteria:

All patients undergoing any of the following urethral surgeries are included:

* Internal urethrotomy according to Sachse (endoscopic transurethral urethrotomy)
* End-to-end anastomosis
* Urethral plastic surgeries with oral mucosa graft (potentially penile skin)
* Urethral plastic surgeries with mesh graft
* Hypospadias corrections
* Boutonniere
* (Self) bougienage of the urethra

Exclusion Criteria:

* Lack of capacity to consent