cyrilzakka/clinical-trials huggingface dataset:
Clinical Investigation Measuring the Long Term Clinical Performance and Safety of Biodentine™ XP in Patients Treated for Coronal Restorative or Endodontic Dental Indications.

The aim of this present study is to collect additional data for the post-marketing follow-up of Biodentine™ XP and measure long-term (up to 10 years) performance and safety of the biomaterial in all its indications.

This clinical investigation is done according to the European Medical Device Regulation (MDR) 2017/745 and is considered as an observational, post-market clinical follow-up study with no additional invasive and cumbersome procedures. Biodentine™ XP has been marketed in the US since 2022 and was launched in Europe in May 2023.

The aim of the study is to collect additional data for the post-marketing follow-up of Biodentine™ XP and measure long-term (up to 10 years) performance and safety of the biomaterial in its coronal restorative and endodontic dental indications.

The investigators participating in the clinical investigation will be general dental surgeron practitioners, with a great experience in restorative and endodontic indications or in pediatric dentistry, also users of Biodentine™.

This Clinical Investigation is an Observational, Prospective, and Multicenter study. This clinical investigation will take place in several investigational centres in France and Belgium.

This Clinical InvestigatioI is a prospective study: Patients will be treated with the study device (according to its CE-marked Instruction For Use), then followed up.

Eligibility Criteria:
Inclusion Criteria:

1. Temporary tooth, from a child ≥ 2 years old, requiring dental restorative treatment with Biodentine™ XP, and/or, Permanent (mature or immature) tooth, from a child or an adult, requiring a dental restorative and/or an endodontic treatment with Biodentine™ XP.
2. Adult patient with a signed informed consent form; For the minor, if in age to understand, an assent is required, and at least one parent or legal representative must consent.
3. Only in France: Subject affiliated or benefiting from a social/health insurance system.

Exclusion Criteria:

1. Patient with one or more documented contraindication to use Biodentine™ XP (Refer to IFU).
2. Inadequate expected tooth lifetime as estimated by the investigator:

   * For a Temporary tooth: high probability of tooth loss within 2 years after treatment with Biodentine™ XP.
   * For a permanent tooth: high probability of tooth loss within 10 years after treatment with Biodentine™ XP.
3. Patient with any systemic disease that may hinder the normal healing process and/or the follow-up.
4. Adult patient under legal protection measures or unable to express his/her consent, and individual deprived of liberty by judicial or administrative decision, as well as individual receiving psychiatric care.
5. Periodontitis (stage 3, 4 or stage 2 grade C).
6. Inability to comply with study procedures.
7. Participation in another interventional clinical investigation that can induce bias in the study results.
Effect of Non Surgical Periodontal Therapy on Inflammatory Markers in Chronic Periodontitis Patients

The current study was performed to study levels of Il-17 and Il-18 in aggressive periodontitis patients before and after non surgical periodontal therapy

Background:host defense factors are involved in pathogenesis of chronic periodontitis so, the current study is assessing levels of Il-17 and Il-18 in chronic periodontitis patients versus periodontally healthy controls.

Subjects and methods: Fifty subjects were included; twenty five of them are diagnosed with chronic periodontitis patients and twenty five are periodontally healthy subjects. Probing depth (PD), clinical attachment level (CAL), plaque index (PI) and gingival index (GI) were recorded for all the enrolled subjects. GCF levels of Il-17 and IL-18 were analyzed by enzyme-linked immunosorbent assay (ELISA).

Eligibility Criteria:
Inclusion Criteria:

* Medically free subjects .
* both genders .
* age range between 30 to 60 years old .

Exclusion Criteria:

* Subjects with periodontal surgeries in the last 6 months.
* Subjects with prior use of antibiotics in the last 6 months.
* Smokers.
* Pregnant and lactating females were excluded.
* Lactating females.
Efﬁcacy of Hyoscine-n-butylbromide in Catheter-related Bladder Discomfort After Elective Cesarean Section.

a prospective, randomized, placebo-controlled study will be conducted to investigate whether hyoscine-n-butylbromide has preventive effects on early postoperative CRBD in patients with urinary catheters who will undergo elective cesarean sections.

The insertion of a urinary catheter in a patient undergoing a surgical procedure as cesarean section may lead to catheter-related bladder discomfort with varying degrees of severity during the postoperative period. Catheter-related bladder discomfort (CRBD) symptoms associated with an indwelling urinary catheter are similar to overactive bladder symptoms such as discomfort in the suprapubic region, urinary urgency, frequency, burning sensation with or without urge incontinence. Hyoscine N-butyl bromide also known as scopolamine is a drug with anticholinergic effects which exerts its effects by inhibiting the acetylcholine effects in parasympathetic receptors of smooth muscle cells, secretory glands, and central nervous system. Hyoscine-n-butylbromide was reported to be effective for treatment of CRBD.

More preventive than therapeutic drugs for CRBD should be investigated to improve patient comfort in all surgery patients with a urinary catheter.

A prospective, randomized, placebo-controlled study will be conducted to investigate whether hyoscine-n-butylbromide has preventive effects on early postoperative CRBD in patients with urinary catheters who will undergo elective cesarean sections.

Eligibility Criteria:
Inclusion Criteria:

* Elective primary or repeat cesarean section at or more than 38 weeks of gestation scheduled to insert a Foley catheter in the operation site.

Exclusion Criteria:

* • Urinary infection (assessed clinically and by urinalysis of midstream sample of urine (MSSU) with chemical indicator strips or dipsticks).

  * Contraindications for general anesthesia.
  * Maternal bladder, urethral and renal disorders causing irritating voiding problems such as dysuria, urge and stress incontinence.
  * Obstructive voiding symptoms like incomplete emptying, straining and voiding difﬁculty before surgery.
  * Overactive bladder (frequency: more than three times during the night or more than eight times in 24 h).
  * Morbid obesity.
  * Disturbances of the central nervous system (epilepsy, patients receiving MAO inhibitor).
  * Hypertensive disorders and/ or systemic disease requiring particular patient care (for example, cardiac disease, nephritic disorders).
  * Chronic analgesic abuse.
  * Hepatic or psychiatric disease will be excluded from the study.
  * A history of hypersensitivity or contraindication to hyoscine-n-butylbromide.
Effect of Varying Testosterone Levels on Insulin Sensitivity in Men With Idiopathic Hypogonadotropic Hypogonadism (IHH)

The investigators are doing this research study to look at the relationship between testosterone (the main sex hormone in men) and insulin (the hormone that controls blood sugar levels) in men with Idiopathic Hypogonadotropic Hypogonadism (IHH).

The investigators hypothesize that normalizing testosterone levels in men with IHH enhances insulin sensitivity, reduces visceral fat, increases lean body mass, and improves the lipid profile.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of idiopathic hypogonadotropic hypogonadism or Kallmann Syndrome
* mean testosterone level less than 300 ng/dl
* stable weight for the previous 3 months (no weight change greater than or equal to 10 lbs)
* normal serum TSH
* normal serum prolactin levels

Exclusion Criteria:

* Type 2 diabetes mellitus
* history of diabetes in parents
* sleep apnea
* bleeding disorder
* seeking fertility
* 2 or more cardiovascular risk factors: smoking, hypertension, diabetes, dyslipidemias, family history of cardiovascular disease before age 60.
* history of previous cardiovascular event: myocardial infarction, unstable angina, cerebro-vascular accident.
* illicit drug use/alcohol use (\>4 drinks per day)
A Study to Characterize the Prevalence of Overweight and Obesity Among Patients With Established Cardiovascular Disease

The purpose of this observational study is to measure how many people are overweight or obese amongst patients with a diagnosed cardiovascular disease (CVD). The study also aims to characterise the population including the presence of cardiovascular (CV) risk factors in a number of countries across the globe representing different geographies, ethnicities, as well as different healthcare systems.


Eligibility Criteria:
Inclusion Criteria:

1. Informed consent obtained before any study-related activities (study-related activities are any procedure related to recording of data according to the protocol).
2. Adults, age above or equal to 18 years at the time of signing informed consent.
3. Have established CVD and equal to or greater than 1 follow up appointment following an acute event from at least one of the following:

   * Prior myocardial infarction
   * Prior stroke (ischemic or haemorrhagic stroke)
   * Symptomatic peripheral arterial disease (PAD), as evidenced by intermittent claudication with ankle-brachial index (ABI) below 85 (at rest), or peripheral arterial revascularization procedure, or amputation due to atherosclerotic disease

Exclusion Criteria:

1. Previous participation in this study. Participation is defined as having given informed consent in this study
2. Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation
3. Patients with known congenital heart disease/malformation
Nordic Pole Walking for Individuals With Cancer

Individuals diagnosed with cancer tend to be inactive and have symptom burdens that impact quality of life. A community-based Nordic Pole Walking (NPW) program may help. The primary objective of this study was to see if it was feasible to do to a larger trial. The secondary objective was to determine the effects of NPW on physical function and health-related quality of life (HRQoL). NPW or no NPW was randomly assigned to adults with non-small cell lung, prostate, colorectal, and endometrial. Eight people were enrolled in the study with 4 in the NPW group (1 dropped out) and 4 in the no NPW group.

Individuals diagnosed with cancer tend to be inactive and have symptom burdens that impact quality of life. An individualized, community-based Nordic pole walking (NPW) program may help. The primary objective of this study was to assess feasibility using the Thabane Framework of a randomized controlled trial (RCT). The secondary objective was to determine the effects of NPW on physical function (six-minute walk test, 30-second \[30-s\] chair stand test, Unsupported Upper Limb Exercise Test, handgrip strength, physical activity \[PA\]), and health-related quality of life (HRQoL, 36-Item Short Form Health \[SF-36\]). The study design was an eight-week multi-centred block randomized controlled feasibility study (no blinding) comparing a NPW program (versus usual daily routine) for adults with non-small cell lung, prostate, colorectal, and endometrial cancer, from hospitals and cancer support groups.

Eligibility Criteria:
Inclusion Criteria:

* a primary diagnosis (including reoccurrence) of histologically confirmed stage I-IV NSCLC, prostate, colorectal, or endometrial cancer (with any concurrent cancer treatment)
* a cancer diagnosis or treatment within the last three years
* ≥ 55 years old
* approval by the primary treating physician
* ability to communicate in English.

Exclusion Criteria:

• engaged in NPW within the last six-months
Evaluating the Bioequivalence of HIP1403 and HGP0919 Suspensions

The purpose of this study is to investigate the bioequivalence after administration of HIP1403 and HGP0919 suspensions in healthy male volunteers.

A randomized, open-label, single dose, crossover clinical trial to investigate and compare the pharmacokinetics between HIP1403 and HGP0919 suspensions in healthy male volunteers.

Eligibility Criteria:
Inclusion Criteria:

1. Healthy male volunteers, age 19 to 45 years.
2. The result of Body Mass Index(BMI) is not less than 18 kg/m2 , no more than 29 kg/m2.
3. Subjects who have ability to comprehend the objectives, contents of study and property of study drug before participating in trial and have willingness to sign of informed consent in writing.

Exclusion Criteria:

1. Presence of medical history or a concurrent disease that may interfere with treatment and safety assessment or completion of this clinical study, including clinically significant disorders in kidney, liver, cardiovascular system, respiratory system, endocrine system, or neuropsychiatric system.
2. Positive serology for HBs antigen, HCV antibody, HIV antigen
Clinical Evaluation of the OEC Elite MD for Vascular Procedures at Hamilton General Hospital

The purpose of this study is to collect feedback on imaging guidance adequacy from physicians who use the OEC™ Elite CFD Mobile Fluoroscopy System-Motorized Configuration to perform surgical procedures for which the use of mobile fluoroscopy is prescribed per standard of care.

Up to 40 eligible subjects will be enrolled and have their clinically indicated procedure completed using the investigational device.

Following completion of each subject's procedure, the investigators will complete a User Survey specific to the workflow and guidance adequacy of the OEC Elite device. The survey will consist of a series of questions on the use of the system as well as anonymized image data.

After all subjects' procedures are completed at a given site, the site investigator will review survey data from the study subjects enrolled at the site and document his/her assessment of the overall acceptability of the system for use in a clinical environment.

There is no statistical hypothesis being tested in this study. Results will be summarized using descriptive statistics.


Eligibility Criteria:
Inclusion Criteria:

1. Male or female between the ages of 18 and 85 years (≥18 and ≤85 years old);
2. Clinical indication for procedures including vascular, gastrointestinal (GI), urology or pain management for which mobile fluoroscopy has been prescribed for image guidance;
3. Able and willing to comply with study procedures; and
4. Able and willing to provide written informed consent to participate.

Exclusion Criteria:

1. Pregnant or suspected to be pregnant based on the opinion of and as documented by a medically qualified physician investigator;
2. Expected to be at increased risk due to study participation (e.g. due to allergies, sensitivities), in the medical opinion of an investigator; or
3. Previously participated in this study, or enrolled in another active GEHC study or other research study that could be expected to interfere with participation in study procedures, in the opinion of the investigator.
Exploring the Role of Magnesium in Rest Cramps

This study sets out to show whether infusions of magnesium can lessen the frequency of rest cramps and to determine whether rest cramp sufferers have a deficiency in magnesium.

Subjects will be randomized to receive 5 days of 4 hour IV infusions of D5W either with or without 20 mmol magnesium sulfate added. Twenty four hour urinary excretion of magnesium will be determined on the first day of infusions to assess whether magnesium deficiency is present. Ten normal controls will also undergo a single infusion and collection of urine to serve as a comparison group for the urinary excretion data.

Eligibility Criteria:
Inclusion Criteria:

* ≥2 leg or foot cramps per week in a 4 week run-in diary

Exclusion Criteria:

* eGFR\<50
* Neurologic disease
* Pregnancy
* Heart block
* Bradyarhythmia without pacemaker
* Digoxin use
* Liver disease
* Addison's disease
* History of MI
* CHF
* Absence of detectable reflexes
VIGABatrin in Post-anoxic STATus Epilepticus - Phase IIa

This is a pilot trial of a single loading dose of vigabatrin in post-anoxic status epilepticus.

This pilot trial aims to demonstrate the feasibility of enteral administration of a single load of vigabatrin within targeted 48 hours of post-anoxic status epilepticus onset in unconscious survivors of cardiac arrest undergoing targeted temperature management. The load of VGB is in addition to the load of a commonly used intravenous second-line therapy given at the discretion of the treating neurologist. Serial blood tests will be obtained, including vigabatrin levels, taurine levels, neuron specific enolase, light chain neurofilament, and glial fibrillary acidic protein. In survivors that regain consciousness and survive to follow up, 6 months visual field perimetry will be obtained.

Eligibility Criteria:
Inclusion Criteria:

* age ≥ 18 years
* non-traumatic cardiac arrest (regardless of non-perfusing rhythm, etiology, or location of arrest) in whom the decision to treat unequivocal electrographic status epilepticus (as defined by the American Clinical Neurophysiology Society: having generalized spike/sharp-wave discharges ≥ 3Hz or any evolving pattern reaching \> 4Hz, lasting ≥ 10 minutes, or comprising \> 50% of any hour of recording) has been made
* requiring anesthetic infusion for any reason
* have reliable arterial access for frequent blood sampling
* established enteral access within 48h of post-anoxic status epilepticus onset.

Exclusion Criteria:

* prior history of generalized epilepsy
* history of gastrointestinal surgery within the last 21 days
* pregnancy
* status epilepticus onset preceding initiation of electroencephalography monitoring
Surgical Treatment of Post-surgical Mastectomy Pain Utilizing the Regenerative Peripheral Nerve Interface

Post-mastectomy pain due to nerve injury leads to long-term opioid use and diminished quality-of-life. The investigators on this study will evaluate the regenerative peripheral nerve interface (RPNI), a novel surgical approach to neuroma treatment, to improve patient-reported post-mastectomy pain and definitively treat intercostal neuromas after mastectomy.

Up to 40% of patients who undergo mastectomy suffer from chronic pain, defined as pain lasting greater than three months. Chronic post-mastectomy pain due to nerve injury leads to long-term opioid use and diminished quality-of-life. A novel surgical approach to neuroma treatment, the regenerative peripheral nerve interface (RPNI) developed to treat painful neuromas associated with limb amputation has shown significant reductions in patient-reported pain. RPNI surgery is now available through Michigan Medicine's Multi-Disciplinary Peripheral Nerve (MDPN) Clinic to improve post-mastectomy pain and definitively treat intercostal neuromas following mastectomy. Using patient-reported outcomes and clinical data the investigators will evaluate the use of RPNI surgery to reduce persistent post- mastectomy pain in women seeking surgical consultation through the Plastic Surgery or MDPN clinics.

Eligibility Criteria:
Inclusion Criteria:

In order to be eligible to participate in this study, a subject must meet all of the following criteria:

* Reporting post-mastectomy pain at least six months removed from mastectomy or partial mastectomy (lumpectomy).
* Willing to comply with all study procedures and be available for the duration of the study
* Fluent in English
* Women of reproductive potential must use highly effective contraception (specify methods of contraception acceptable for the study, e.g., licensed hormonal methods) and/or willingness to undergo a pregnancy test.

Exclusion Criteria:

A potential subject who meets any of the following criteria will be excluded from participation in this study:

* Previous surgical management for chronic post-mastectomy pain
* Signs/symptoms which are not suggestive of neuropathic pain based on physical exam at time of consultation.
* Pregnancy or lactation
* Men will not be enrolled in this study due to the low prevalence of male mastectomy.
* Anything that, in the opinion of the investigator, would place the subject at increased risk or preclude the subject's full compliance with or completion of the study.
Improving Pharmacological Transition of Palliative Care Patients From Inpatient to Outpatient Care

The transition of palliative care patients from inpatient to outpatient care is aimed to be improved through structured pharmaceutical discharge management by a trained pharmacist. This data will be compared with retrospective cases.

As part of a prospective observational study with a retrospective comparison group, a pharmacist should, on request, check the discharge medication planned by the primary care physicians before discharge and discuss it with the various colleagues providing (follow-up) care. In addition, the availability in the outpatient "medicine cabinet" and the possibility of prescribing by the responsible GPs (by telephone) should be checked in advance. In addition, longitudinal focus groups with relevant stakeholders are to be conducted to collect quantitative data as well as qualitative data on the views of those providing and receiving treatment.

There will be cooperation with the Specialized Outpatient Palliative Care Service Muenster to ensure sufficient case numbers and a low rate of missing values through partial use of the standard care data from the "Information System Palliative Care" (ISPC) program they use.

Eligibility Criteria:
Inclusion Criteria:

All individual indications for general and specialised palliative care as part of routine clinical practice (e.g.):

* advanced, malignant tumour disease
* advanced, chronic obstructive pulmonary disease
* Patients with advanced disease and limited life expectancy (approx. 12 months) Further care in the SOPC Muenster (prospective data) Sufficient understanding of the German language to be able to understand the information and consent form

Exclusion Criteria:

Impossibility of understanding the information and declaration of consent.
Effects of Perioperative Administration of Intravenous Lidocaine in Children Operated on for Acute Generalized Peritonitis

Intravenous administration of lidocaine perioperatively after laparotomy for peritonitis could be an interesting alternative by reducing the duration of postoperative ileus, the intensity of pain and the patient's hospital stay, as well as the cost of management in our context of lack of financial, technical and human resources, hence the present study.


Eligibility Criteria:
Inclusion Criteria:

* All patients aged 6 to 15, Classified according to the American Society of Anaesthesiologists (ASA) (I, II and III) admitted for peritonitis and whose parents have given informed consent

Exclusion Criteria:

* State of shock
* Severe renal insufficiency (creatinine clearance less than 30 ml/min)
* History of allergy to lidocaine
* Refusal to participate in the study