cyrilzakka/clinical-trials huggingface dataset:
TENS in Scleroderma

The goal of this pilot study is to assess the acceptability of the transcutaneous electrical acustimulation (TEA) device in treating Scleroderma-related gastroparesis. The main objective is:

To evaluate the acceptability of TEA as an intervention for alleviating symptoms of distension and bloating in individuals diagnosed with Scleroderma.

Participants will be provided with the TEA devices that will be applied to the skin for a total of 45 minutes twice daily after meals. Participants will be asked to fill out both daily diaries and biweekly questionnaires to assess for improvement in the gastroparesis symptoms.


Eligibility Criteria:
Inclusion Criteria:

1. Classification of Systemic Sclerosis according to the 2013 American College of Rheumatology and European League against Rheumatism classification criteria.
2. Age \&gt;= 18 years
3. English speaking.
4. Participants who report moderate to severe symptoms of distension/bloating on UCLA Scleroderma Clinical Trials Consortium Gastrointestinal Tract Instrument 2.0
5. Stable GI specific therapy including prokinetics over the last 4 weeks.

Exclusion Criteria:

1. Pregnancy, or currently lactating.
2. A history of major abdominal surgery (other than cholecystectomy, appendectomy, or deemed as non-major by the investigators)
3. Unrelated active disorder which may involve abdominal pain, such as inflammatory bowel disease, diabetes or unstable thyroid disease.
4. Known allergy to adhesive ECG electrodes.
5. Known contraindications to TEA (e.g., cardiac pacemaker, epilepsy)
Drug Utilization Study on Diane-35 (and Generics) in Three European Healthcare Databases

The study objectives are to characterize new users of Cyproterone Acetate / Ethinylestradiol (CPA/EE) in 2011/2012 and in 2014 according to demographics, treatment characteristics, previous diagnosis of acne, hirsutism or other hyperandrogenic conditions, previous acne treatment and (concomitant) use of hormonal contraceptives identified in Healthcare Databases in the UK (THIN), the Netherlands (PHARMO) and Italy (HSD).


Eligibility Criteria:
Inclusion Criteria:

* The study population will include all female patients registered in the investigated healthcare databases receiving CPA/EE in 2011 or 2012 (first run) or 2014 (second run), without a prescription of CPA/EE in the year prior to index date. Only patients with recorded history in the database of ≥ 365 days prior to index date will be included in the study.

Exclusion Criteria:

* \<365 days recorded history in the database prior to index date
* a prescription of CPA/EE in the year prior to index date
Aging With HIV and Neurocognitive Decline, a Follow-up Study

The ANRS ( Agence Nationale de Recherches sur le Sida et les Hépatites virales) 0093s Aging HAND study is to assess whether PLHIV (People Living with HIV) initially between 55-70 years of age at baseline analysis under antiretroviral therapy have accelerated decline of neurocognitive function after 6 years of follow-up.

Aging HAND is a French, multicentric, longitudinal, transversal, prospective study with inclusion of 290 PLHIV.

The primary objective of this study is to analyze whether PLHIV initially aged between 55-70 years of age at baseline under antiretroviral therapy have accelerated decline of neurocognitive function after 6 years of follow-up in comparison with an age, gender and educational level matched HIV non-exposed control group from the CONSTANCES cohort.

The secondary objectives of this study are :

* To determine the prevalence of neurocognitive impairment (NCI) according to the Frascati criteria, clinical consensus and alternative classifications, after additional accrual of individuals aged 55 to 76 years for a more precise and extensive age range analysis of NCI
* To describe the incidence and prevalence of the frailty syndromes, and their relation with co-morbidities and NCI, using the Fried score as a measure of frailty
* To constitute a plasma and serum biobank for biomarkers study related to the aging of PLHIV

Eligibility Criteria:
Inclusion criteria

Inclusion criteria for PLHIV for the longitudinal study:

* Having participated in the ANRS EP58 HAND 55-70 study
* A signed informed consent
* To be affiliated and benefit from the French Social Security

Inclusion criteria for PLHIV for the transversal study (only for new subjects):

* HIV-1
* Aged between 55 years and 76 years;
* with a viral load \< 50 copies/mL for more than 24 months (with a minimum of 3 available viral loads 6 months prior to inclusion). Blips -defined by a transient increase in viral load- are allowed if \< 200 copies/mL, with a maximum of two blips within 24 months;
* With a CD4 (cluster of differentiation 4) count at inclusion ≥ 200 cells/µL for more than the last 12 months (with a last available CD4 count \< 6 months of inclusion);
* A signed informed consent
* To be affiliated and benefit from the French Social Security

Exclusion criteria

Non-inclusion criteria for PLHIV for both the longitudinal and transversal studies:

* An Isolated HIV-2 infection
* Confused or with an ongoing neurological disease
* Presenting psychiatric syndromes interfering with cognitive evaluation;
* With sensorial loss, analphabetism or language barriers rendering the interpretation of tests difficult.
* With recent extensive neurocognitive evaluation within 6 months prior to inclusion
* With neurological disease with ongoing clinically relevant sequela
* Participating in another research program, prohibiting the participating in additional research
* Vulnerable: minors, under guardianship or curatorship, or persons deprived of liberty for administrative or judiciary reasons
Endocrown Restorations Longevity Compared With Post Retained Restorations

Caries disease is still the leading cause of severe tooth decay. Since this can lead to tooth loss, it is important that appropriate treatment is advised to help prevent damage and maintain tooth health. Faced with major coronary destruction, several times it becomes necessary to perform the endodontic treatment, aiming to maintain the element in the buccal cavity for longer. It is known that an excellent restorative treatment with poor endodontic treatment and the inverse has a direct impact on the (in) success of the treatment. In this context, the proper cleaning of the root canals is highlighted, aiming the removal of bacteria and toxins. Acceptable restorations are those that provide adequate reestablishment of anatomy, function, proximal contacts, and occlusal stability. Traditionally, indirect restorations would be indicated in cases of extensive coronary destruction, because it was believed that they would present greater resistance and longevity when compared to direct restorations. However, contemporary dentistry admits that, thanks to adhesive and conservative principles, this difference between direct and indirect procedures in terms of longevity is not significant. The classic restorative procedure in cases of endodontically treated teeth with great loss of coronary structure involves the use of intraradicular retainers, followed by the creation of core and restoration through total crowns. Removal of healthy tissue for the use of posts can weaken the remaining dental structure and increase the risk of root perforations. In this sense, endocrown restorations show superiority when compared to those made with intraradicular retainers. Although the indications are favorable for the use of endocrown restorations, the clinical evidence available on the subject is still scarce. In this double-blind randomized clinical trial, patients who need and meet the inclusion criteria will will be allocated to one of the three restorative groups available, being endocrown restoration in semi-direct composite resin, direct restoration in composite resin retained on the post and ceramic crown retained in the post. Patients will be monitored annually after completion of restorative treatment outcome. In addition to treatment longevity, other secondary outcomes will be evaluated, such as patient satisfaction, impact on quality of life and cost-effectiveness of the proposed treatments.


Eligibility Criteria:
Inclusion Criteria:

* 18 years old or more;
* healthy volunteers;
* molars or premolars with endodontic treatment and large coronal destruction;
* at least 20 teeth;

Exclusion Criteria:

* abutment of removable partial denture ;
* tooth with mobility higher than 1;
* more than 1/2 bone loss height;
Prognosis of Elderly Patients With Acute Poisoning.

Acute poisoning is a major public health problem all over the world, it causes significant mortality and morbidity. It primarily involves younger populations, with less than 3% of the affected cases being in people aged 60 years or older in most studies. More than half of the intoxication events in the elderly over 65 years old were accidental.

The elderly are different from younger adults in many aspects. There are age related physiological changes. They have a higher incidence of comorbidities and use of many medications for chronic conditions, both of which make the elderly more susceptible to acute poisoning and its related consequences.

Although the elderly form a relatively small proportion of those admitted to hospital for acute self-poisoning, the poisoning in them is often more serious, complications are more frequent and a fatal outcome is more common.

The presence of multiple physical, social, and psychiatric problems, with possible difficulties in the diagnosis of poisoning make the management of the elderly more complicated than that of younger poisoned patients. There are three main difficulties in diagnosing acute poisoning in the elderly. At first, it may not be easily obvious that the patient has taken an overdose. Secondly, the presence of pre-existing diseases may obscure the clinical picture and finally, the drug may cause physical signs that similar to common problems of old age.

Eligibility Criteria:
Inclusion Criteria:

all patients more than 60 years will be included.

Exclusion Criteria:

younger than 60 years.
Screen-detected Coeliac Disease, a Population Based Study

The purpose of this study is to determine the prevalence of previously undiagnosed coeliac disease based on a health survey from Tromsø, Norway. Moreover, the health impact of undiagnosed coeliac disease will be examined.

Few population-based studies have examined the prevalence of coeliac disease and the impact of undiagnosed coeliac disease on health. Moreover, the number of people with undiagnosed coeliac disease is much higher than the number who know their diagnosis.

The purpose of this study is to determine the prevalence of coeliac disease and the impact of undiagnosed coeliac disease on health.

In a health survey of the population of Tromsø Norway, serological markers of coeliac disease (transglutaminase 2, TG2 and deamidated gliadin antibody test) have been analyzed. Individuals with increased level of one of these markers, will be invited for upper endoscopy with small bowel biopsy examination to confirm the diagnosis of coeliac disease. All persons with screen detected coeliac disease, will be advised to start a gluten free diet.

Health status and Quality of Life will be examined by means of the Gastrointestinal Symptoms Rating Scale (GSRS) and the Psychological General Well-Being Index (PGWBI) respectively.

1. At baseline GSRS and PGWBI will be analyzed in persons with screen detected and biopsy verified coeliac disease and compared with a group of healthy control persons from the health-survey cohort.
2. In a prospective study of the persons with screen detected coeliac disease, health status (GSRS) and Quality of Life will be compared before and after one year on a gluten free diet.

Eligibility Criteria:
Inclusion Criteria:

* Increased level of serological markers (Transglutaminase 2 or Deamidated Gliadin) and biopsy verified coeliac disease

Exclusion Criteria:

* Previously diagnosed coeliac disease
Clinical and Microbiological Efficacy of Chloramine and Hyaluronic Acid Gels in Non-surgical Periodontitis Treatment

The aim of the study is to investigate clinical and microbiological effects of subgingival application of chloramine (Perisolv) and hyaluronic acid (Hyadent BG) gels as adjuncts to scaling and root planing in non-surgical periodontitis treatment.

Objectives:

1. To evaluate if additional subgingival delivery of chloramine and hyaluronic acid gels would enhance clinical outcomes of scaling and root planing in periodontitis patients.
2. To assess if additional subgingival delivery of chloramine and hyaluronic acid gels would reduce total counts of periodontopathogenic bacteria compared to scaling and root planing alone.

The treatment will consist of two treatment modalities: (1) Control group - full mouth scaling and root planing (SRP) (2) Test group - full mouth SRP + "Perisolv"+ Hyadent BG gels.

The periodontal treatment will be performed in one session without time restrictions. Under local anesthesia, an experienced operator, will perform a full mouth subgingival scaling and root planing with an ultrasonic device and Gracey curettes. Afterwards, all teeth will be polished using a low-abrasive paste.

Teeth in the test group (all teeth with PD ≥ 5 mm) will adjunctively be treated with chloramine gel (Perisolv), which will be inserted into periodontal pockets before and during SRP (2 times). The nozzle will be placed in the pocket mesially, lingually, distally and bucally. Teeth will be polished and all treated pockets will be filled with hyaluronic acid gel.

Teeth in control group will receive SRP + polishing

Eligibility Criteria:
Inclusion Criteria:

* \> 30 years old;
* Good general health according to medical history and clinical judgment;
* Exhibiting at least one pocket in each quadrant with pocket depth (PD) ≥ 5 mm;
* Radiographic evidence of bone loss ( \> 2 mm from cemento-enamel junction (CEJ) );
* Untreated periodontal disease;
* Minimum 20 teeth (wisdom teeth excluded);
* No removable prosthesis.

Exclusion Criteria:

* Patients already included in other clinical trials;
* Periodontal treatment during the last 12 months;
* Antibiotic treatment 6 months prior to the start of the trial;
* Antibiotic prophylaxis required for dental treatment;
* Ongoing medication that may affect the clinical features of periodontitis;
* Pregnant/lactating.
Metabolic Syndrome in Psoriasis and Psoriatic Arthritis and Correlation With Serum Omentin and Visfatin Levels

In this study, the prevalence of metabolic syndrome in psoriatic and psoriatic arthritis patients as well as the parameters of metabolic syndrome will be examined. At the same time, the levels of omentin and visfatin adipokines associated with metabolic syndrome and obesity will be measured by measuring the disease severity (by PASI psoriasis, clinical activity score for psoriatic arthritis). The patients who accepted to participate in the study , who were admitted to the dermatology outpatient clinic were included in the study. For the blood tests required after the examination, 2 tubes of blood will be taken for the measurement of omentin and visfatin. 80 psoriasis, 40 psoriatic arthritis and 60 healthy volunteers were planned to be studied. AHA / NHLBI, 2005 (revised ATP III criteria) criterion for the diagnosis of metabolic syndrome will be used. Omentin and visfatin levels are compared with the severity of the disease for psoriasis and psoriatic arthritis, and it will be examined whether it is proinflammatory or antiinflammatory.


Eligibility Criteria:
Inclusion Criteria:

1. Patients followed up for psoriasis and psoriatic arthritis in dermatology and rheumatology clinic
2. Patients older than 18 years
3. Patients who accept dermatological and rheumatic examination
4. Patients not receiving systemic treatment related to the disease in the last 1 month

Exclusion Criteria:

1. Patients with autoimmune and rheumatic diseases other than psoriasis and psoriatic arthritis
2. Patients under 18 years
3. Patients who do not accept dermatological and rheumatic examination Patients receiving systemic therapy for the last 1 month pregnant and nursing moms
SPY Fluorescence Imaging Systems and Indocyanine Green to Determine the Percentage of Successful Critical Anatomy Recognition in Laparoscopic Cholecystectomy Surgeries.

This is a prospective single arm, single center study estimating percentage of successful critical anatomy recognition in laparoscopic cholecystectomy surgeries using SPY fluorescence imaging and ICG, with each surgery also providing a white light 360 degree images.

The primary objective is to determine the percentage of successful critical anatomy recognition using intra-operative SPY fluorescence imaging and ICG: and to describe complications associated with intra-operative decision making in patients undergoing laparoscopic cholecystectomy.


Eligibility Criteria:
Inclusion Criteria:

* Subject is 18 years of age or older
* Subject is scheduled to undergo laparoscopic cholecystectomy, elective or emergent
* Subject provides informed consent and signs an approved informed consent document for the study
* Subject is willing to comply with the protocol and study visit schedule

Exclusion Criteria:

* Subject is pregnant or lactating
* Subject has a known allergy or history of adverse reaction to ICG, iodine or iodine dyes
* Subject has known history of cholangitis, pancreatitis, prior bile duct injury, coagulopathy or known pre-existing liver disease
* Subjects who, in the Investigator's opinion, have any medical condition that may make the subject a poor candidate for the investigation, interferes with the interpretation of study results, or integrity of the study
Post-Covid Condition Cohort: Evolution of Symptomatology, Patient Profile and Associated Prognostic Factors

The aim of our cohort is to collect prospectively, in a standardized and exhaustive manner, the health data of patients referred to the CAPCoV, our holistic referal post covid clinics for post-covid condition in order to be able to identify typical profiles of patients suffering from post covid syndrome and to follow the evolution of their disease over time.


Eligibility Criteria:
Inclusion Criteria:

* outpatients treated in the Nancy University Hospital Long Covid Support and Care Center for post-Covid condition according to WHO definition

Exclusion Criteria:

* patient opposing the processing for research purposes of their data collected in routine care for their care
Nitrate Supplementation; Duration

The main aim of the current study will be to find the optimal duration of supplementation to enhance sports performance.

Oral ingestion of nitrate (NO3-) in the form of both nitrate salts and beetroot juice has been shown to significantly lower blood pressure at rest and to also lower pulmonary oxygen uptake during exercise, in addition to improving exercise performance during cycle time trial. However, there has been no consensus on the optimal supplementation protocols, in terms of duration of supplementation to see these metabolic effects. Furthermore, a positive exercise performance effect of nitrate ingestion has primarily been observed in recreational athletes. The potentially ergogenic effects of nitrate in well-trained or elite athletes therefore remain to be fully established. Based on the gaps in current literature, our main goal will be to gain further insight into different aspects of nitrate supplementation to enhance (elite) sports performance. This will be investigated in this study by assessing the effect of an acute vs. chronic supplementation period of sodium nitrate (NaNO3-) on exercise performance.

Eligibility Criteria:
Inclusion Criteria:

* 18.5 \< BMI \< 25 kg/m2
* Endurance trained cyclists/triathletes (with at least 1 year of competitive cycling experience)
* VO2max ≥ 55 mL/kg/min

Exclusion Criteria:

* Use of medication
* Injury prohibiting them from performing the exercise protocol effectively
* Smoking
* Currently supplementing diet with nitrate
* Lactose intolerance
Watchful Waiting of Incisional Hernias

This study is being conducted to gain a better understanding of the quality of life for patients with a diagnosis of primary and recurrent incisional hernias and 1) who decline to have surgery to repair the hernia or 2) patients who cannot have surgery because their health will not allow them or 3O if surgery to repair the hernia is completed. A comparison will be made between those who receive surgery and those who do not.

This study is being conducted to gain a better understanding of the quality of life for patients with a diagnosis of primary and recurrent incisional hernias and 1) who decline to have surgery to repair the hernia or 2) patients who cannot have surgery because their health will not allow them or 3O if surgery to repair the hernia is completed. A comparison will be made between those who receive surgery and those who do not.

Subjects will fill out three survey forms on quality of life and pain at baseline and again at six and 12 months. Measurements of change in hernia size will be made, life-style changes such as smoking cessation, weight-loss, tighter control of diabetes will be initiated for outcome comparison with controls.

Eligibility Criteria:
Inclusion Criteria:

1. abdominal hernia greater than 3 cm2
2. 18 years of age
3. able to give informed consent

Exclusion Criteria:

1. abdominal hernia less than 3 cm2 or greater than 127 cm2
2. unable to return to clinic for follow-up visits