cyrilzakka/clinical-trials huggingface dataset:
Study of Periodontal Tissues in Fixed Prostheses on Natural Teeth

When the tooth is severely compromised, it needs a prosthetic crown. The tooth is prepared to allow the housing of the prosthetic crown without difficulty. This study aims to compare two different types of preparations to see with which of the two the gingival tissue reacts best.


Eligibility Criteria:
Inclusion Criteria:

1. Need for restoration by single-tooth prosthetic crown, due to destructive caries, coronal fracture, endodontically treated tooth, severe abrasion, aesthetic problems, remake of old incongruous prosthetic crown, other complications.
2. If there are incongruous conservative restorations (composite fillings or other materials) in the elements adjacent to the tooth to be treated, these must be restored before the prosthetic therapy and must not be modified during the protocol.
3. Absence of active periodontal disease
4. over the age of 18;
5. periodontal probing less than 4 mm in the tooth to be treated
6. absence of bleeding on probing
7. full-mouth plaque score (FMPS) and full-mouth bleeding scores (FMBS) \< 20% at the start of the study
8. Patients according to protocol participation and informed consent signature.

Exclusion Criteria:

1. contraindication to dental treatment
2. active periodontal disease
3. systemic diseases that may affect periodontitis
4. Pregnant women
5. Patients in orthodontic therapy
6. inability to return to the controls or to follow oral hygiene maintenance.
ICG Use in Angiography for Nasoseptal Flap Harvest

This is a feasibility study in which indocyanine green (ICG) will be administered during routine expanded endonasal approach (EEA) for cranial base pathologies in which a nasoseptal flap harvest will be necessary. The research entails administering ICG, which is already widely used during open neurosurgical procedures, to identify the blood supply at two distinct stages of endonasal cranial base surgery: during nasoseptal flap harvest and after final positioning of the nasoseptal flap to ensure its viability before ending the case.

This study is being done to determine if it is feasible to use angiography during endo-nasal surgery. During the angiography indocyanine green (ICG) will be injected into the patients IV tubing to help see the arteries. ICG is routinely used in vascular surgeries on the brain but not for endo-nasal surgery. The purpose of this study is to see how well intraoperative angiography using ICG can be done during endonasal surgery.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 and above
* Patients undergoing an EEA for cranial base pathology that may require nasoseptal flap harvest

Exclusion Criteria:

* History of sulfa, iodide, or penicillin allergy
* Pregnant or breast feeding
* Preoperative lack of indication for nasoseptal flap harvest
* Previous anaphylactic reaction to ICG
Ascending Dose Study of the Safety and Tolerability of REGN668(SAR231893) in Normal Healthy Volunteers

This study will test the safety and tolerability (how the body reacts to the drug) of REGN668 and placebo (an inactive substance that contains no medicine) in healthy subjects.


Eligibility Criteria:
Inclusion Criteria:

1. Male or female 18 to 65 years of age.
2. Weight \> 50 kg and \< 120 kg.
3. For women of childbearing potential, a negative serum pregnancy test at the screening visit (visit 1) and a negative urine pregnancy test on day -1.
4. Willingness to refrain from the consumption of alcohol for 24 hours prior to each study visit.
5. For men and women of childbearing potential, willingness to utilize adequate contraception and not become pregnant (or have their partner\[s\] become pregnant) during the full duration of the study.
6. Willing, committed, and able to return for ALL clinic visits and complete all study-related procedures.
7. Able to read, understand and willing to sign the informed consent form.

Exclusion Criteria:

1. Onset of a new exercise routine or major change to a previous exercise routine within 4 weeks prior to screening visit.
2. Pregnant or breast-feeding women.
3. Significant concomitant illness or history of significant illness such as cardiac, renal, neurological, endocrinological, metabolic or lymphatic disease, or any other illness or condition that would adversely affect the subject's participation in this study.
4. Hospitalization for any reason within 60 days of screening (visit 1).
5. Known history of Human Immunodeficiency Virus (HIV), Hepatitis B or Hepatitis C, and/or positive Hepatitis B surface antigen (HBsAg), positive Hepatitis C antibody (HCV).
6. Previous exposure to any therapeutic or investigational biological agent. results.
7. History of alcohol or substance abuse within previous 5 years.
Study of SARS-CoV2 Virus (COVID-19) Seroprevalence in the Population of Creil Air Force Base (BA110)

In mid-February 2020, within the Oise (France) cluster, a case of COVID-19 disease caused by a SARS-CoV2 infection was described among the personnel of the Creail Air Force Base (BA110). This resulted in the beginning of an epidemic controlled by epidemiological measures. One month later, containment measures were taken at the national level, measures that also applied to BA110 personnel. These personnel, exposed to both the initial phase of the epidemic and national protection measures, represent an extremely interesting population for understanding the epidemiological dynamics of the virus, particularly at a time when France is lifting the containment measures. It becomes extremely important to understand the levers of viral spread in order to adjust the health measures to be maintained as best as possible.

The main objective of this study is to determine the extent of virus diffusion in this highly circulating population, as evidenced by several identified cases of COVID-19.


Eligibility Criteria:
Inclusion Criteria:

* Active military or civilian defence personnel working on the Creil Air Force Base (BA110) during the period of interest (from February 1st 2020 to the end of the study)

Exclusion Criteria:

* Contraindication to blood sampling
* Pregnant, parturient, breastfeeding woman
Evaluation of PerioMonitor for Detection of Oral Inflammatory (OI) in Human Subjects in Medical Practice

The purpose of the study is to evaluate the usability of PerioMonitor™ in a medical clinic environment and to evaluate the effectiveness of a referral system from physicians to dentists for patients identified with high oral inflammation.

PerioMonitor™ is an In Vitro Diagnostic (IVD) device intended as an aid in the detection of oral inflammation in individuals of 18 years and older. This test is intended for use at point-of-care (POC) sites by health care professionals (e.g., physicians, nurses, medical assistants, dentists, dental hygienists, and dental assistants).


Eligibility Criteria:
Inclusion Criteria:

* subject fluent in English
* subject has signed the ICF

Exclusion Criteria:

* subject with altered mental status/inability to provide informed consent or follow the procedure of the Study
* Previous enrolment into the current Study
* Patients with known severe oral diseases such as oral cancer
Evaluation of Pregnancy Outcome with Usage of Drug-free In-vitro Activation of Follicles Ovary

This study is the pilot study to evaluate the effect of Drug-free in vitro activation to improve the outcomes of IVF in poor responder women

First, patients who are poor responders based on Poseidon criteria 1, 3 (women under 35 years of age who either have abnormal ovarian reserve tests or have not had an adequate ovarian response in an IVF cycle) are included in the list of poor responders and are consulted after a complete evaluation by a physician. The patient has a history of poor response in previous IVF cycles. After obtaining the patient's consent, the patient undergoes laparoscopy. The laparoscopy procedure will be performed at Milad Infertility Center, which is equipped with a laparoscopy operating room and a laboratory nearby. The procedures will be performed by a single surgical team that includes laparoscopy and infertility flowsheets. After general anesthesia and pre- and post-operative care, double puncture laparoscopy will be performed. Two minor trocars will be placed, which will be held in place by an ovarian grasper. With scissors, a part of the ovarian cortex is first separated from the underlying medulla and strips of cortex 1 to 2 mm thick and 10 mm long are removed. They are immediately transferred to the adjacent laboratory. A 1 x 5 mm sample from the removed piece is used for histological examination and determination of the number of remaining follicles. The tissue is then divided into 1 x 1 x 1 mm pieces. The removal site will be sutured in case of bleeding. The preparation of the ovary into small pieces will be performed by a single physician for all patients. The prepared pieces are immediately transferred to the operating room. Then the surgeon places the prepared pieces in the tunnel between the cortex and medulla in the opposite ovary and then sutured. The patient is then followed up and immediately treated with FSH (Sinagene Company, Tehran, Iran) at a maximum dose of 300 units, and then the dose is adjusted according to the ovarian response. When a 12 mm follicle is observed, 0.25 mg of Sterotide (Merck Serono, Mississauga, Canada) is started. When the size of 1 or 2 follicles reaches 16, 10,000 units of HCG (Puyish Daru Company, Tehran, Iran) and two ampoules of Deca (Decapeptyl 0.2 mg, Ferring, Germany) are given together for triggering. Ovulation is performed 36 hours later under transvaginal ultrasound guidance.

Eligibility Criteria:
Inclusion Criteria:

* Women under 35 years of age who have one of the following characteristics:

Or poor response to gonadotropins in a previous IVF cycle (fewer than 3 oocytes in a previous IVF cycle)

Or ovarian reserve test AMH less than 1.1

Exclusion Criteria:

* Unwillingness to continue working with the researcher during the procedure
Fetal Heart Rate Variability

Need statement

- a new way to distinguish between a healthy small fetus and a small fetus suffering from deprivation of nutrition and oxygen to prevent unnecessary induction of preterm birth and improve neonatal outcome.

Aim - to characterize fetal heart rate variability (fHRV) based on fetal ECG in the normal fetus and in the fetus suffering from growth retardation to evaluate its value and applicability as a supplementary tool in fetal surveillance.

Aim of current study

- To evaluate the feasibility of NI-FECG from gestational week 20 and onwards and investigate if important factors as length and heart rate pattern affects repeatability of time domain and spectral analyses in fetuses.


Eligibility Criteria:
Inclusion Criteria:

• Healthy singleton pregnancies

Exclusion Criteria:

• Fetal malformations, multiple pregnancy, obstetric complications, maternal chronic disease and labor.
Motivation Makes the Move!

This study evaluates the effect and usability of mobile and cloud technology -based intervention on lifestyle modification in 18-40 year obese and overweight subjects.

The study has a dose-response design with three randomized subjects groups from Mode 1 to Mode 3 with increasing intensity of intervention (guidance, exercise program, diet, support). The special focus of this study is on motivation and use of music and mobile health devices as motivational tools to support individualized exercise training, healthy diet and overall healthy life style.

Obesity negatively impacts health in many ways. It is associated with metabolic diseases and mood disorders and in women pregnancy outcome as well as the health of the offspring.

The modern evolution of societies steers populations towards a profound sedentary lifestyle. Physical activity brings about health benefits, however, the risk reduction for chronic diseases remains significantly greater for fitness than physical activity per se. The recent knowledge suggest Individualized approach rather than general guidelines for exercise in prevention-oriented strategies.

In this study we compare three different intensities of lifestyle intervention: 1) general guidelines for healthy exercise and diet, 2) individual program,and 3) highly individual program. Individual programs will be based on pre-examinations including interview and clinical exercise test. Mobile and cloud technologies will be used to collect data and steer the subjects´ lifestyles and daily activities and together with music to motivate them. The duration of the active intervention is 3 months and it will continue on a self-governing basis up to 1 year. The primary outcome is maximal oxygen consumption (VO2max), and secondary outcomes are physical activity, cardio-respiratory and cardiovascular parameters, blood volume, total hemoglobin mass, metabolic health along with chronic low-grade inflammation and well-being.

Eligibility Criteria:
Inclusion Criteria:

* BMI ≥ 27,5 kg/m2
* estimated by health care personnel to benefit from lifestyle modification

Exclusion Criteria:

* inability to perform exercise testing and intervention (physical, mental or other reason)
* not able to operate in Finnish (some applications only in Finnish for the time being)
* severe anemia (Hb\<108 g/l for women and \< 124 g/l for men)
* smoking (disturbs autonomic nervous system measurements)
* regular medication affecting glucose metabolism (excluding insulin) or autonomic nervous system (e.g. beta blockers, SSRI)
* ongoing pregnancy or breast feeding
* prisoner
Predicting Response to CRT Using Body Surface ECG Mapping

Cardiac resynchronization therapy (CRT) involves pacing the left and right side of the heart in order to improve the coordination of the contraction in patients with heart failure. Current selection criteria incorporate the severity of the symptoms, the mechanical function of the heart and the time it takes the electrical stimulation to spread over the left ventricle (as assessed on the standard 12 lead electrocardiogram-ECG). Unfortunately these criteria only seem to select approximately 70% of the patients who might respond to this invasive therapy. Body surface ECG mapping is a new technique that assesses the electrical activation of the heart in more detail than the standard ECG. This study aims to determine whether this new technology may aid current selection criteria in predicting response to CRT.


Eligibility Criteria:
Inclusion Criteria:

* Age \>18 years old
* Fulfils established clinical criteria for CRT implantation (with or without a defibrillator)
* NYHA Class III-IV Heart Failure (or NYHA II with NYHA III/IV symptoms in the preceding 12 months)
* LVEF \<35% (Calculated using echocardiography or Cardiac MR) at the time of implantation
* QRS duration \> 130ms
* Optimal Tolerated Medical Therapy for Heart Failure

Exclusion Criteria:

* Severe, life threatening non cardiac disease
* Active malignant disease and recent (\<5 years) malignant disease
* Prior Heart Transplant
* Recent history of unstable angina, acute coronary syndrome or myocardial infarction within three months of enrolment into the study
* Pregnancy
* Failure to participate in consent process
* Atrial Fibrillation
* Conventional pacemaker in situ
* Heart Failure requiring constant intravenous therapy including diuretics and/or inotropes
* Recent revascularisation procedure i.e. coronary artery bypass grafting (CABG) or percutaneous coronary intervention (PCI) within the last three months
Comparison of Effect on Quality of Recovery Outcome Between Systemic Lidocaine and Dexamethasone in Patients Undergoing Laparoscopic Cholecystectomy

The primary purpose of this study is to compare the effect of lidocaine and dexamethasone on postoperative quality of recovery after laparoscopic cholecystectomy


Eligibility Criteria:
Inclusion Criteria:

* ASA I-II patients aged between 20 and 65 year undergoing laparoscopic cholecystectomy due to gallbladder polyp or asymptomatic gallstones without cholecystitis

Exclusion Criteria:

1. Steroid therapy or immunocompromised patients
2. Diabetes mellitus
3. Allergy to lidocaine or dexamethasone
4. Severe renal dysfunction (serum creatinine more than 1.6mg/dl)
5. Severe liver disease ( liver enzymes more than two times normal values)
6. History of atrioventricular block
7. Have a difficulty in understanding QoR-40 (40-item quality-of-recovery scoring system) or Korean language
8. History of physicologic disease
Study Investigating Administration of Prevenar for Post-Marketing Surveillance

The purpose of this study is to identify the following problems and questions with respect to the safety of Pneumococcal 7-Valent Conjugate Vaccine (Diphtheria CRM 197 Protein), Prevenar, during the post-marketing period in Korea, as required by Korea Food and Drug Administration (KFDA) regulations.

1. Adverse reactions (especially serious adverse reactions)
2. Incidences of adverse reactions under routine vaccine use
3. Factors that may affect the safety of the vaccine


Eligibility Criteria:
Inclusion Criteria:

* Infants and children aged 6 weeks to 9 years, provided the conditions pertaining to contraindications, warnings, precautions, and interactions stated in the package insert do not apply.

Exclusion Criteria:

* Hypersensitivity to latex or to any component of the vaccine, including diphtheria toxoid
* Suffering from a current or recent febrile illness.
Acute Exposure of Simulated Hypoxia on Cardiac Output

Randomized crossover trial in patients with Pulmonary Hypertension (PAH, CTEPH) to assess the acute response to simulated altitude (FIO2: 15.1% = equivalent to 2500m above sea level) on non-invasive cardiac output assessments by Finapres® "NOVA" Technology at rest and under exercise.

Low altitude baseline measurements will be performed in Zurich (470m asl) including Echocardiography, right heart catheterization, six-minute walk test (6MWT), pulmonary function test, clinical assessment and blood gas analysis at rest and under exercise.

Randomly assigned to the order of testing, the participants will be tested under simulated altitude (FiO2: 15.1% with the "AMC Altitrainer") and shamed altitude with the same device.

During the exposure to simulated altitude (FiO2: 15.1%) and shamed altitude of 1 hour each, the participants cardiac output non-invasively assessed will be measured throughout the whole intervention.

Eligibility Criteria:
Inclusion Criteria:

* Informed consent
* PH diagnosed according to internation Guidelines: mean pulmonary artery pressure (mPAP) ≥ 25 mmHg along with a Pulmonary artery Wedge pressure (PAWP) ≤15 mmHg during right heart catheterization at the time of initial diagnosis
* PH class 1 (PAH) or 4 (CTEPH)
* Stable condition, on the same medication for \> 4 weeks
* Patient live permanently at an altitude \< 1000m asl.

Exclusion Criteria:

* Resting partial oxygen pressure (PaO2) ≤7.3 kiloPascal (kPA) corresponding to the requirement of long-term oxygen therapy \> 16hour daily (nocturnal oxygen therapy alone is allowed)
* Severe daytime hypercapnia (pCO2 \> 6.5 kPa)
* Susceptibility to high altitude related diseases (AMS, High Altitude Pulmonary Edema (HAPE), etc.) based on previous experienced discomfort at altitudes.
* Exposure to an altitude \>1500m for ≥3 nights during the last 4 weeks before the study participation
* Residence \> 1000m above sea level
* Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, neurological or orthopedic problems with walking disability
* Women who are pregnant or breast feeding
BAP1 Testing in Instance Choroidal Nevi or Uveal Melanoma

The BAP1 trial will examine the blood of patients diagnosed with choroidal nevi or uveal melanoma for a germline BAP1 mutation and other genetic markers associated with developing malignancy as well as additional sequencing of the uveal melanoma genome.

A germline BAP1 mutation predisposes a person to developing uveal melanoma and other cancers. If a mutation is discovered, it changes the potential approach to managing the nevus. In the presence of a known genomic change associated with aggressive disease, closer follow up and more aggressive treatment could preserve the patient's vision and prevent micrometastatic spread. This new screening technique will be able to extend the length and quality of life of patients with more frequent targeted cancer screens.

Eligibility Criteria:
Inclusion Criteria:

any person with choroidal nevi

* Willingness to provide signed informed consent
* Age \> 18 years
* Diagnosis of choroidal nevi or uveal melanoma

Threre are no exclusionary criteria for this study.
Relationship Between EIT and Respiratory Status in Very Preterm Infants

Electrical Impedance Tomography (EIT) is a non-invasive imaging technique that can measure lung function in real time. This study will follow premature infants to see if EIT can help predict which infants will be successful in weaning off respiratory support by 32-33 weeks gestational age. If successful, EIT could be used to develop new guidelines for respiratory support in premature infants.


Eligibility Criteria:
Inclusion Criteria:

* Infants admitted to the UMass Memorial Medical Center (UMMMC) Neonatal Intensive Care Unit (NICU)
* Born between 25+0- and 29+6-weeks of gestation

Exclusion Criteria:

* Infants with major congenital anomalies
* Infants with severe hemodynamic instability
Treatment of Primary Breast Cancer Using PDT

Phase I/IIA, open label, non-randomised, single site trial in patients with primary breast cancer.

This is a phase I / IIa study recruiting patients diagnosed with primary breast cancer. Patients who have chosen mastectomy or wide local excision as their surgical option will be included. Patients will have a pre therapy MRI followed by photodynamic therapy. PDT involves intravenously injecting the photosensitizer Verteporfin (Visudyne) drug. This drug makes the tumour sensitive to light. A non-thermal light will then be shone in the tumour which brings about tissue necrosis (destruction). Although the drug dose will remain the same, the light dose will be escalated depending on patient response in accordance to a predefined algorithm (see section) to achieve a zone of necrosis of 12mm or a plateau of necrosis with incremental increase in light dose. An MRI will be performed immediately prior to the scheduled surgery. Pre and post PDT MRI changes will be correlated with the histological findings on the excised breast specimen. Should the minimum light dose for 12mm necrosis be established recruitment will continue until 12 patients have received this dose. These 12 patients will provide sample data on the size of tumour and area of necrosis detected by MRI and histology to enable sample size (power) calculations for future studies of PDT in primary breast cancer. This is a dose escalation study involving a minimum of twelve and a maximum of forty patients.

Eligibility Criteria:
Inclusion Criteria:

1. Patients aged 30 or over
2. A uni-focal invasive ductal breast carcinoma or discrete uni-focal site which is deemed suitable for PDT within a multifocal invasive ductal carcinoma in a single breast.
3. Patients who have opted for mastectomy or wide local excision as primary treatment.
4. Capable of giving written informed consent

Exclusion Criteria:

1. Patients who are not undergoing surgery as their primary treatment.
2. Patients undergoing surgery for DCIS without invasive breast cancer.
3. Patients with Lobular cancer
4. Patients with Necrotic tumours
5. Distant metastatic disease.
6. Patients will be excluded if they have porphyria or are sensitive to verteporfin (visudyne).
7. Patients who have severe cardiovascular disease.
8. Patients with severe or uncontrolled systemic disease e.g. hepatic impairment.
9. Patients with laboratory findings that make it undesirable for the patient to participate in the trial.
10. Male breast cancer patients
11. Pregnancy and lactation.
12. No patients with any psychiatric disorder making reliable informed consent impossible.
13. Patients will be excluded if taking part in any other trial of an experimental medicine
14. Patients will be excluded if taking endocrine therapy drugs that could confound the results.