cyrilzakka/clinical-trials huggingface dataset:
Wound Assessment Using Spectral Imaging EU/UK

During the observational, non-interventional study, at Baseline Study Visit (BSV) subjects will be screened and consented. Eligible subjects will undergo imaging with the DeepView device. Pre- and post-debridement images will be obtained (if debridement performed per SOC), as well as reviewing medical history and physical assessments.

Additional Study Visits (SVs) will be performed when patient returns to the clinic for Routine Clinic Visit for up to 12 weeks or wound closure. During these visits DeepView imaging will occur pre- and post-debridement, and the status of the subject's treatment will be recorded.


Eligibility Criteria:
Inclusion Criteria:

* At least 18 years old.
* Subject has an ulcer, or a slow healing wound that is full thickness for at least 4 weeks, below the malleolus, in the presence of Diabetes.
* The target ulcer will be the largest ulcer if two or more eligible DFUs are present and will be the only one evaluated in the study.
* The target ulcer is planned to undergo standard wound care (SWC) therapy (See 8.6 Standard Wound Care (SWC) Therapy).
* Subject understands and is willing to participate in the clinical study and can comply with required visits.

Exclusion Criteria:

* Target ulcer is deemed by the investigator to be caused by a medical condition other than diabetes.
* Target ulcer, in the opinion of the investigator, is suspicious for cancer and should undergo an ulcer biopsy to rule out a carcinoma of the ulcer.
* Eligible DFU has associated untreated acute osteomyelitis or active infection
* Subjects with a history of more than two weeks treatment with immunosuppressants (including systemic corticosteroids \>10mg daily dose), or cytotoxic chemotherapy.
* Subjects on any investigational drug(s) or device(s) within 30 days preceding initial study visit.
Effect of Probiotics on Periodontitis Stage III Grade C Molar-incisor Pattern

the research highlight the effectiveness of probiotics as adjuncts to SRP in the treatment of periodontitis stage III grade C molar-incisor pattern

Background data : Periodontitis is a common disease that represents a public health problem. Aggregatibacter actinomycetemcomitans (A. a ) especially the JP2 genotype plays a major role in the pathogenesis of periodontitis. The aim of this study is to evaluate the effect of topically applied probiotics on the management of periodontitis stage III grade C molar-incisor pattern.

Methods: Sixty-five patients having periodontitis stage III grade C molar-incisor pattern. Screening for A. actinomycetemcomians (A.a) and the JP2 genotype was done using conventional polymerase chain reaction (PCR). Patients positive for (A. a) were randomly divided into two groups. Group I: received conventional periodontal treatment combined with topically applied probiotic, while Group II: received conventional periodontal treatment only. Both groups were evaluated microbiologically and clinically. Quantitative assessment of A. a levels was done by real time PCR (qPCR) at baseline as well as one week, 4 weeks, and 12 weeks after treatment. Clinical parameters were assessed before treatment as well as 3,6 and 9 months after treatment.

Eligibility Criteria:
Inclusion Criteria:

* patients have periodontitis stage III grade C molar-incisor pattern .

Exclusion Criteria:

* Pregnant or nursing women,
* smokers,
* patients received periodontal therapy,
* systemic antimicrobials or anti-inflammatory drugs in the last six
* patients with unacceptable oral hygiene
The Efficacy and Safety of Remimazolam Besylate for Cardiac Anesthesia

The evidence on the practice of remimazolam besylate during cardiac anesthesia is scarce. This study investigates the efficacy and safety of remimazolam besylate general induction and maintenance during cardiac surgery.

Remimazolam besylate (RB), as a new benzodiazepine sedative agent, has been approved in clinical anesthesia with prominent characteristics of short onset/offset, less depression for cardiovascular or respiratory function and specific antagonist. Some studies have confirmed the comparable anesthesia efficacy of remimazolam for outpatient digestive endoscopy, fiberoptic bronchoscopy, facial plastic and orthopedic surgery as propofol. Currently, the evidence on its application in cardiac anesthesia is insufficient. Our study aims to evaluate the efficacy of remimazolam besylate and propofol and provide an ideal anesthetic agent to achieve the goal of early recovery after cardiac surgery.

Eligibility Criteria:
Inclusion Criteria:

1. Elective cardiac surgery via cardiopulmonary bypass;
2. Aged 18-65 years;
3. American Society of Anesthesiologists (ASA) grade I-III;
4. Body mass index (BMI) 18-28 kg/m2.

Exclusion Criteria:

1. A history of sternotomy for heart disease;
2. Angina or arrhythmia with severe dynamics flutters pre-operation;
3. Respiratory, hepatic or renal dysfunction (oxygenation index\<300, alanine transaminase\> 2 upper limits of normal value, creatinine \> 200 μmol/L);
4. Diagnosed with advanced tumors;
5. Psychiatric or mental disorders;
6. Myasthenia gravis or seizures;
7. Pregnant or lactating females;
8. A history of benzodiazepines administration within 3 months before surgery;
9. Known allergic to benzodiazepines, opioids, propofol and flumazenil;
10. Involved in another interventional clinical trial.
The Impact of the Biologist Performing the Embryo Transfer on the Cycle Outcome

This is a retrospective single center analysis which includes all the fresh, IOC (insemination of in vitro matured oocytes) and frozen embryo transfer (ET) performed between January 2000 and December 2019 at Humanitas Fertility Center after IVF-ICSI (In Vitro Fertilization - Intracytoplasmic Sperm Injection) cycles.

The primary objective is to determine the impact of the biologist performing the embryo transfer on the pregnancy probability, in terms of ongoing pregnancy rate (OPR), defined as the number of viable pregnancies that had completed at least 12 weeks of gestation on the total number of ET performed.

Secondary end point is to evaluate whether the biologists improve their performances as their experience increases, allowing the drawing of an ET learning curve in term of pregnancies for the different biologists.

The biologist's experience was assessed in terms of number of previous interventions performed prior to the day of ET. A total of 28 operators were eligible to participate in the study. Any biologists who performed less than 100 ETs was excluded from the analysis.


Eligibility Criteria:
Inclusion criteria:

Exclusion Criteria:

Any biologist who performed less than 100 embryo transfers was excluded from the analysis.
DISCOVERing Treatment Reality of Type 2 Diabetes in Real World Settings

DISCOVER is a Non Interventional Study study to describe the disease management patterns and clinical evolution over three years in type 2 diabetes mellitus patients initiating a second line anti-diabetic treatment.

DISCOVER is a NIS study to describe the disease management patterns and clinical evolution over three years in type 2 diabetes mellitus patients initiating a second line anti-diabetic treatment. This study is a multi-country, multicenter, observational, prospective, longitudinal cohort study. The patients will be recruitted from countries in Latin America, Europe and Asia pac. It is estimated that approximately 13350 patients will be enrolled in total with each patient followed up for 3 years.

Eligibility Criteria:
Inclusion Criteria:

1. Provision of subject informed consent
2. Female or male aged 18 years and over
3. Diagnosed with type 2 diabetes mellitus
4. Initiating a second line anti-diabetic therapy, either as add-on, or switching from one monotherapy to another.

Exclusion Criteria:

1. Diagnosis of type 1 diabetes mellitus
2. Patient is pregnant
3. Patients initiating a dual therapy after having previously received two different lines of monotherapy before (e.g.: Metformin → SU (Sulphonylureas) → SU+Add-on)
4. Current treatment with chemotherapy, oral or iv steroids
5. Patient is on dialysis or has had a renal transplant
6. The patient is taking insulin as first line treatment
7. The patient is taking dual therapy or a fixed dose combination treatment as first line treatment.
8. The patient is taking herbal remedies / natural medicines as first line treatment
9. Participation in an interventional trial
10. Presence of any condition/circumstance which in the opinion of the investigator could significantly limit the complete follow up of the patient for 3 years (e.g. lifethreatening co-morbidities, tourist, non-native speaker or does not understand the local language where interpreter services are not reliably available, psychiatric disturbances, dementia, alcohol or drug abuse).
11. Not willing to sign the informed consent.
Outcomes After Weight Loss Surgery in Low-Risk Patients

The purpose of this research is to determine patient-reported outcomes after weight loss surgery, including changes in health, mood, quality of life, health satisfaction, and emotional health, in low-risk patients. Weight loss surgery has been well studied for patients with body mass index (BMI) 35 kg/m\^2 or more and those with weight-related medical problems who have a BMI 30 kg/m\^2 or more. However, outcomes after weight loss surgery in patients with BMI under 35 kg/m\^2 and without co-morbidities have not been well studied.

The purpose of this research is to determine patient-reported outcomes after weight loss surgery in low-risk patients. Weight loss surgery has been well-studied for patients with body mass index (BMI) 35 kg/m\^2 or more and those with weight-related medical problems who have a BMI 30 kg/m\^2 or more. Weight-related medical problems, also called co-morbidities, can include diabetes mellitus, hypertension, sleep apnea, and degenerative joint diseases. The surgery is considered safe and effective. Outcomes after weight loss surgery in patients with BMI under 35 kg/m\^2 and without co-morbidities have not been well studied. The investigators' purpose is to study patient-reported outcomes after weight loss surgery in patients with BMI between 30 kg/m\^2 and 34.5 kg/m\^2 without co-morbidities. These include changes in health, mood, quality of life, health satisfaction, and emotional health.

Eligibility Criteria:
Inclusion Criteria:

* Patients with BMI between 30 kg/m2 and 34.5 kg/m2 without co-morbidities who are medically cleared to undergo cosmetic weight loss surgery.
* Written informed consent obtained from the subject or the subject's legal representative and the ability for the subject to comply with the requirements of the study.

Exclusion Criteria:

* Patients who are pregnant.
* Patients with BMI below 30 kg/m2.
* Patients with BMI above 34.5 kg/m2.
* Patients who have co-morbidities including, but not limited to, diabetes mellitus, hypertension, sleep apnea, and degenerative joint disease.
* Patients who are not medically cleared to undergo weight loss surgery.
Safety, Tolerability, and Pharmacokinetics of PTI-808, PTI-801, and PTI-428 Combination Therapy in Subjects With Cystic Fibrosis

The study is a randomized, double-blind, placebo-controlled, study that will be conducted at multiple centers in subjects with Cystic Fibrosis (CF) who are either homozygous for the F508del mutation or heterozygous with at least copy of the F508del mutation.

Study PTI-808-02 will enroll up to approximately 32 subjects. Subjects in the first cohort will receive PTI-808 and PTI-801. Following completion of Cohort 1, initiation of enrollment into subsequent cohorts will be based upon review and approval by the Safety Review Committee (SRC).

Eligibility Criteria:
Inclusion Criteria:

* Cohorts 1,2 and 4: A Confirmed diagnosis of CF with the F508del/F508del CFTR genotype on record, along with clinical findings consistent with CF such as chronic sinopulmonary disease or gastrointestinal/nutritional abnormalities
* Cohort 3 only: Confirmed diagnosis of CF with at least one copy of the F508del CFTR mutation on record, along with clinical findings consistent with CF, such as chronic sinopulmonary disease or gastrointestinal / nutritional abnormalities
* Forced expiratory volume in 1 second (FEV1) 40-90% predicted, inclusive
* Non-smoker and non-tobacco user for a minimum of 30 days prior to screening
* Cohort 3 only: A sweat chloride value of ≥60 mmol/L based on quantitative pilocarpine iontophoresis (as documented in the subject's medical record or as confirmed at the screening visit)

Exclusion Criteria:

* Currently taking or has taken a CFTR modulator within 30 days prior to initial dose of study drugs
* Participation in another clinical trial or treatment with an investigational agent within 28 days or 5 half-lives, whichever is longer, prior to Study Day 1
* History of cancer within the past 5 years
* History of organ transplantation
* Hospitalization, sinopulmonary infection, CF exacerbation, or other clinically significant infection or illness (as determined by the investigator) requiring an increase or addition of medication, such as antibiotics or corticosteroids, within 14 days of Day 1
* Initiation of any new chronic therapy (e.g., ibuprofen, hypertonic saline, azithromycin, Pulmozyme®, Cayston®, TOBI®) or any change in chronic therapy (excluding pancreatic enzyme replacement therapy) within 28 days prior to Day 1
* History or current evidence of alcohol or drug abuse or dependence within 12 months of screening as determined by the investigator
* Pregnant or nursing women
Muscle Strength, Physical Work Capacity and Functional Performance in Individuals With Down Syndrome

This project will evaluate muscle strength and its relationship to everyday function in individuals with Down Syndrome.


Eligibility Criteria:
Inclusion Criteria:

* Down Syndrome
* Mild or moderate mental retardation
* Able to tolerate exercise testing

Exclusion Criteria:

* Uncontrolled cardiovascular disease
* orthopedic limitations to exercise
Effectiveness of Dance Therapy in Fibromyalgia.

The purpose of this study is to analyze the effects of an intervention with dance on balance,movility, pain and sleep in patients with Fibromyalgia in comparison to a control group that will have an educational intervention.

Fibromyalgia is a chronic disease consisting of widespread pain, fatigue, sleep disturbances, and cognitive impairments, among other symptoms, which affect daily physical activity.

The regular physical exercise improves the functional, physiological, and behavioral components of physical fitness. Dance therapy seems to increase motivation and adherence to therapy, and can provide a real alternative to conventional exercise

The experimental group will receive a dance program treatment .

The control group will receive an educational intervention.

Eligibility Criteria:
Inclusion Criteria:

* Being over 18 years of age until 64.
* Being diagnosed with FMS in accordance with American College of Rheumatology - ACR

Exclusion Criteria:

* Participants with diagnoses of other inflammatory rheumatic diseases, previous neurological or orthopedic diseases,
* Use aids for balance, hearing and visual problems.
* Cognitive impairment.
Predictability of the Ability to Perform an Emergency Stop With Disorders of the Hip

Several studies exist on patient performance in drive simulators especially around and after surgery. Recommendations concerning the ability to drive preoperatively are based on these studies, which generated their data using drive simulators. However, in all the datasets driving performance remains highly individual. Since a drive simulator is not readily available in normal general practitioner surgeries it would be helpful to have convenient clinical tests to evaluate a patients individual ability to perform an emergency stop. This study aims at evaluating different possibilities how such performance might be predicted. Patients with hip osteoarthritis and patients who have received total hip arthroplasty are tested clinically and their results are compared with the gold standard experiment - a drive simulator.


Eligibility Criteria:
Inclusion Criteria:

* 18-85 y
* valid driving license
* male and female
* Hip Osteoarthritis, Total hip arthroplasty
* capability to walk with or without a walking stick

Exclusion Criteria:

* myocardial infarction/Apoplexia \< 6 months
* Total hip arthroplasty \<5 weeks
* New York Heart Association 3/4
* lacking drivers' license
* peripheric sensomotor deficit \<3/5 British Medical Research Council
* new fracture of the lower extremity or spine
* systemic or metastasised Cancer
* drug intake with centrally acting substances known to affect reaction time (Opioids, e.g. Tramadol, oxycodone, morphine, Til
Non - Incised Papilla Versus Single Flap Technique In The Reconstruction Of Intrabony Defect

The present study will aim to assess the effectiveness of the non-Incised Papilla surgical approach NIPSA used for the surgical debridement of deep intraosseous defects compared to the single-flap approach SFA.

Primary outcome: interproximal clinical attachment level gain Secondary outcomes: residual probing pocket depth (PPD), pocket depth (PD) reduction, recession (REC), location of the tip of the papilla (TP), width of the keratinized tissue (KT), wound closure (WC), supra-alveolar attachment gain (SUPRA-AG)

The present study will aim to assess the effectiveness of the non-Incised Papilla surgical approach NIPSA used for the surgical debridement of deep intraosseous defects compared to the single-flap approach SFA.

Primary outcome: interproximal clinical attachment level gain Secondary outcomes: residual probing pocket depth (PPD), pocket depth (PD) reduction, recession (REC), location of the tip of the papilla (TP), width of the keratinized tissue (KT), wound closure (WC), supra-alveolar attachment gain (SUPRA-AG)

Eligibility Criteria:
Inclusion Criteria:

* - Age \> 18 years
* Diagnosis with stage III-IV periodontitis.
* Presence of one or more intrabony defects with probing pocket depth (PPD) \> 5 mm and radiographic defect depth \> 4 mm.
* Full-mouth plaque score (FMPS) and full-mouth bleeding score (FMBS) \< 30% (measured at four sites per tooth).
* No relevant systemic condition or disease.

Exclusion Criteria:

Third molars and teeth with type III mobility or with an incorrect endodontic or restorative treatment.

-
A Phase 2 Clinical Study of KHK4827

This study is designed to evaluate the efficacy and safety of KHK4827 in subjects with moderate to severe plaque psoriasis in a randomized, double-blind, placebo-controlled, parallel group study. Pharmacokinetics of KHK4827 will also be assessed.


Eligibility Criteria:
Inclusion Criteria:

* Subject has had stable moderate to severe plaque psoriasis for at least 6 months.
* Subject has received at least one previous phototherapy or systemic psoriasis therapy or has been a candidate to receive phototherapy or systemic psoriasis therapy in the opinion of the investigator.
* Subject has involved BSA ≥ 10% and PASI ≥ 12 at screening and at baseline.

Exclusion Criteria:

* Subject diagnosed with erythrodermic psoriasis, pustular psoriasis, medication-induced, or medication-exacerbated psoriasis.
* Evidence of skin conditions at the time of the screening visit (eg, eczema) that would interfere with evaluations of the effect of investigational product on psoriasis.
* Subject has any active Common Terminology Criteria for Adverse Events (CTCAE) grade 2 or higher infection
* Subject has a significant concurrent medical condition or laboratory abnormalities, as defined in the study protocol.
* Subject has used the following therapies within 14 days of the first dose: topical calcineurin inhibitors including tacrolimus

  , topical vitamin A, activated form D3 or activated form D3 analogue preparations, weak through strong topical steroids (excluding application on the scalp, axillae, and groin)
* Subject has used the following therapies within 28 days of the first dose: any other systemic psoriasis therapy (eg, vitamin A, calcineurin inhibitors, methotrexates, steroids), UVA therapy (with or without psoralen), very strong or strongest topical steroid, tar therapy
* Subject has used the following therapies within 3 months of the first dose: adalimumab, etanercept, infliximab, or live vaccines
* Subject has used ustekinumab within 6 months of the first dose
* Subject has previously used an anti-interleukin-17 biologic therapy
Cervical Cancer in French Guiana: Screening Between 2006-2011

Given that cervical cancer is the second most frequent cancer among women in french guiana the aim of the study was to determine the screening rate among women living in French Guiana. Cervical smears are read in 2 laboratories which allowed us to compute screening rates per 100 women-years. overall the screening activity was 23.5-25.8 smears per 100 women-years. between 2006 and 2011 54% of women were screened. These baseline figures will allow to evaluate present efforts to increase the screening rate for this frequent cancer in French Guiana.


Eligibility Criteria:
Inclusion Criteria:

* women screened

Exclusion Criteria:

-
A Phase 2 Randomised Controlled Trial to Evaluate Efficacy and Safety of Anaprazole in Patients With Duodenal Ulcers.

A phase 2,double-blinded, double dummy, parallel, positive drug, randomised controlled multicenter trial to evaluate efficacy and safety of 4 weeks treatment of Anaprazole 20mg QD, 40mg QD compared with rabeprazole 10mg QD in patients with duodenal ulcers.


Eligibility Criteria:
Inclusion Criteria:

1. Age ≥18 years, male and female
2. Has endoscopic diagnosis of active duodenal ulcer(s) (A1 or A2 stage) within 7 days prior to randomization
3. 1 or 2 ulcers, 3-15 mm in diameter.
4. Signed informed concent form

Exclusion Criteria:

1. Has malignancy ulcer or malignancy ulcer not excluded, compouned ulcer, stress ulcer, esophageal erosion and ulcer, reflux esophagitis, Zollinger-Ellison syndrome.
2. Has esophageal and gastric varices；
3. With severe compliaction, such as pyloric obstruction, bleeding (Forrest I, IIa and IIb) or perforation, and etc；
4. Has other gastrointestinal disease (e.g.gastric ulcer), or has history of inflammatory bowel disease (such as Crohn's disease or ulcerative colitis)；
5. Has undergone surgical resection or partly resection of esophageal, stomach or duodenum；
6. Has used Proton Pump Inhibitors(PPIs) within 5 days prior to randomization, or continuous more than 3 days of use of Proton Pump Inhibitors within 2 weeks prior to randomization；
7. Has been treated with triple or quandruple Helicobacter pylori eradication therapy included PPIs within 28 days prior to randomization；
8. Current use the drugs (such as systemic glucocorticoids, non steroid anti-inflammatory drugs, or anticoagulation drugs) which may induce ulcer or ulceric bleeding or continuous more than 3 days of use the drugs (such as systemic glucocorticoids, non steroid anti-inflammatory drugs, or anticoagulation drugs) within 28 days prior to randomization；
9. Laboratory tests performed in screning stage revealed Alanine aminotransferase (ALT) or aspartate aminotransferase (AST): \> 1.5 upper limit of normal (ULN);
10. Laboratory tests performed in screning stage revealed thyroid stimulating hormone (TSH)；
11. Woman in pregnancy or lactation period；
12. Plan for pregancy or not willing to contracept with reliable contraception method during study period and within 90 days after the final time of investigational drug administratio；
13. Have alcohol abuse or drug abuse 1 years prior to screening；
14. Has hypersensitivity or allergy to investigatory drug, comparatory drug or related supplements；
15. Has participated or been participating other clinical trials(non-interventional study is excluded)；
16. Has an uncotroled disease, such as has a history of significant central nervous system (CNS), cardiovascular, pulmonary, hepatic, renal, or mental or psychological disorders with drug treatment that,in the opinion of the investigator, would not be suitable for participating this clinical trial.
17. In the opinion of the investigator, the patients with other situation would not be suitable for participating this clinical trial.