cyrilzakka/clinical-trials huggingface dataset:
Study of Sublingual Versus Oral Misoprostol Administration Following Mifepristone 200 mg for Abortion up to 63 Days Gestation

This open-label, randomized study is being conducted to determine whether a dose of 400 mcg of sublingual misoprostol (i.e., under the tongue) taken 24 hours following administration of mifepristone 200 mg is effective and acceptable at inducing an abortion compared with misoprostol taken orally.

The goal of this study is to provide answers to the following four questions:

1. Is a regimen of medical abortion with mifepristone using sublingual misoprostol at least as effective as using oral misoprostol up to 63 days since the last menstrual period (LMP)?
2. Are the side effects with sublingual use tolerable for women?
3. Is sublingual administration of misoprostol acceptable to women?
4. Is one of the regimens (sublingual or oral) superior in terms of efficacy, safety (side-effects) or acceptability?


Eligibility Criteria:
Inclusion Criteria:

* Women presenting for medical abortion who consent to participate
* Possibility of final gestational age of less than or equal to 63 days
* General good health
* Willing to provide contact information for purposes of follow-up

Exclusion Criteria:

* Conditions which contraindicate the use of mifepristone or misoprostol
* Women presenting for medical abortion who do not consent to participate
Efficacy and Tolerability of Two Different Administration Routes With SLITonePLUS Birch

Multicentre Phase II trial, comparing two different administration routes of SLITonePLUS Birch in regard to pharmacodynamic efficacy and tolerability.


Eligibility Criteria:
Inclusion Criteria:

* A history of Birch pollen allergy
* Positive skin prick test to birch
* Positive specific IgE to birch

Exclusion criteria:

* Uncontrolled or severe asthma (FEV1\<70% of predicted value in spite of adequate pharmacologic treatment)
* Previous treatment by immunotherapy with birch or a cross-reactingtree pollen allergen within the previous 5 years
* Concomitant SLIT with any allergen
Buparid/PARI SINUS Versus Budes® Nasal Spray in the Therapy of Chronic Rhinosinusitis

The study should create data for the selection of a clinically relevant endpoint to assess the potential of Buparid/PARI SINUS to postpone sinus surgery in patients with chronic Rhinosinusitis.

The objective of this study is to analyse whether Buparid/PARI SINUS has a higher potential to avoid or postpone sinus surgery in adult patients with CRS than Standard of Care therapy with Budes® Nasal Spray. The results of this study are expected to provide estimates for a proper sample size calculation to conduct a pivotal study.

Eligibility Criteria:
Inclusion Criteria:

* Patient with confirmed diagnosis of chronic rhinosinusitis
* Patient without alternative other than sinus surgery
* Patient's written informed consent obtained prior to any screening or study-specific procedure
* Male or female, ≥ 18 years of age
* Patient is able to undergo nasal therapy without restrictions
* Capable to correctly use the PARI SINUS device
* Capable of understanding the purpose and risk of the clinical trial
* Female patients with childbearing potential must have a negative urine pregnancy test prior to first IMP administration.
* Patient is able to participate in the study according to Investigator's opinion

Exclusion Criteria:

* Patients with cystic fibrosis
* Patients with polyposis nasi grade I-IV
* Patients with prior FESS (Functional Endoscopic Sinus Surgery)
* Pregnant or breastfeeding women
* Any active invasive bacterial, viral or fungal infection within one week prior to first investigational medicinal product (IMP) administration
* No clinically relevant abnormal parameters of vital signs, blood biochemistry or renal/hepatic function
* Unlikely to comply with visits, inhalation procedures or other measurements scheduled in the protocol
* Receipt of an investigational drug as part of a clinical trial within 4 weeks prior to first administration of IMP
* Any co-existing medical condition that in the Investigator's judgement will substantially increase the risk associated with the patient's participation in the clinical trial
* Psychiatric disorders or altered mental status precluding understanding of the informed consent process and/or completion of the necessary procedures
* Drug or alcohol abuse
* End-stage malignancies
* Known hypersensitivity to Budesonide
* Patients with oral steroid therapy within the last 3 months
* Patients needing \> 1 mg/day Budesonide (or steroidal equivalent) for therapy of asthma
* Patients on therapy with leukotriene-receptor antagonists, decongestants, antihistamines or antibiotics
* Patients with frequent epistaxis (\> 1 episode per week)
Anxiolytic Effects of Lavender and Orange Oil

The aim of this study is to determine the possible anxiety reducing effects of lavender oil and orange oil on parents with children receiving dental care under sedation during perioperative wait.

Anxiety is a common problem for parents with children under sedation. It has long been known that operations, unconsciousness, the risks of the anesthesia and airway problems can cause a considerable amount of anxiety. Anxiety is associated with an uncertain psychological distress , and may vary to minor disturbances to extreme stress. The study aims to help parents improve their satisfaction by reducing their anxiety levels and ensure they have a better experience. In addition, anxiety can also prevent active participation of the parents during postoperative recovery. The physical and psychological effects of essential oils and traditional medicine practices as aromatherapy has been used for a long time and has potency to reduce using sedatives. Lavender oil is a fragrance that many of us have experienced in growing up at home and is also popular today. The lavender plant belongs to the Labitae family and has been used for centuries in dried or essential oil form. Lavender is obtained from flower heads and leaves with vapor distillation. This oil has also been specifically investigated and is an essential oil scientifically shown to reduce patient anxiety before various interventions. Orange oil is an essential oil produced by cells within the rind of an orange fruit (Citrus sinensis fruit). In contrast to most essential oils, it is extracted as a by-product of orange juice production by centrifugation, producing a cold-pressed oil. It is composed of mostly d-limonene. This oil has been investigated and shown to reduce anxiety and improve mood before various interventions.The anxiolytic effects of these essential oils has not been investigated for parents with children undergoing pediatric dental procedures under sedation.

The aim of this study is to investigate the effects of lavender oil and orange oil diffused in the perioperative waiting room of parents with children under sedation.

Eligibility Criteria:
Inclusion Criteria:

To be the parent of a child undergoing pediatric procedures under deep sedation.

To be over 18 years old. Volunteering to fill pre-operative anxiety tests.

Exclusion Criteria:

Hypersensitivity to lavender/orange and its products. Being on any medication. Being a psychiatric or psychological problem and being under treatment. Current upper airway infection or asthma story. Not want to be involved in the study.
Evaluation of Dental Coronal Restorations

The purpose of this study is to provide the latest information on the oral health status of patients, the lifetime of restorations, to quantify the incidence of defects rates on inserted restorations in conservative dentistry. Moreover, the study permits to compare needs of two different patient populations depending on the place of consultation (those consulting in hospital services and those consulting in private structures) and to compare the quality of coronary fillings in patients with of Gougerot Sjogren disease and those not affected.

A minimum sample of 840 adult subjects consecutively seen at the investigator's office over a period of 33 months is expected ; 400 subjects included in private structures and 440 subjected included in university hospital services (8 to 15 patients per investigator), including at least 40 patients with Gougerot Sjogren disease (disease prevalence = 0.1%).

The investigators of these study are 46 dentists working in private dental practices or private structures of dental care spread over the " Ile-de-France " and " Rhône-Alpes Auvergne " régions and 43 dentists working in 13 french university hospital services in odontology, including two hosting one consultation for Gougerot Sjogren disease, from the ReCOL network (Recherche Clinique en Odontologie Libérale).


Eligibility Criteria:
Inclusion Criteria:

* Patient having read and signed the information letter attesting to his/her non-opposition
* Affiliated to a social security scheme
* Patient over 18 years old
* New patient in the practice or in the hospital service, that can be a classical odontalogical service or a consultation specializing in Gougerot Sjogren disease, with no history of a dental examination less than six months old, or Patient who has not consulted in the last six months
* Patient with at least one tooth with partial coronal restoration

Exclusion Criteria:

- Patient under tutorship or curatorship
Patient Satisfaction & Abutment Teeth Health in Maxillectomy Patients

randomized controlled trial in maxillectomy patients with two types of obturators with different manufacturing techniques

randomized controlled trial measuring patient satisfaction and abutment teeth health in maxillectomy patients rehabilitated with laser polished CAD CAM obturators versus conventionally constructed obturators

Eligibility Criteria:
Inclusion Criteria

* Patients with hemi maxillectomy
* Sufficient number of natural teeth not less than 5 teeth
* Age between 30 and 60 years
* Intact soft palate

Exclusion Criteria

* Cognitive impairment
* Heavy smokers
* Patients exposed to radiotherapy
APOSTrophe Study (Parenteral Nutrition and Bone Trophicity) Impact of a Long-term Parenteral Nutrition on Bone Metabolism Measured by High Resolution Peripheral Quantitative Computer Tomography (HR-pQCT) in Children and Young Adults

Recent progress in parenteral nutrition has contributed to improve vital prognosis and to reduce morbidity in patients with severe intestinal failure.

Currently, home parenteral nutrition is the only alternative to prolonged hospitalization for those patients. However, long-term parenteral nutrition can result in complications especially in bone, such as osteopenia or osteomalacia, then increasing the risk of fractures. Children are especially at risk because of bone growth and peak mineralization acquisition during puberty.

Moreover, frequency and risk factors of those complications are not well documented for children.

Dual-energy X-ray Absorptiometry (DXA) is considered as the golden standard for bone mineralization measurement. In pediatrics, this technique has some limits such as the underestimation of Bone Mineral Density (BMD) in short stature, the overestimation of the BMD in tall children, and the inability to distinguish cortical from trabecular bone or to evaluate the bone microarchitecture.

HR-pQCT, High Resolution peripheral Quantitative Computed Tomography enables noninvasive assessment of bone microarchitecture (virtual bone biopsy) using a radiation similar to DXA. However this technique has never been validated in patients with long-term parenteral nutrition.

During the usual follow-up of the patients, HR-pQCT will be the only exam which will come in addition to the routine medical tests.


Eligibility Criteria:
Inclusion Criteria:

* Patient who's receiving a long-term parenteral nutrition (over 2 years)
* Patient between 9 and 30 years of age (children big enough to stay immobile for 3 min during the measurement)
* Affiliation to the Social Security System
* Informed consent form signed by parents and assent given by the patient

Exclusion Criteria:

* Patient presenting a bone disease which is not directly related to the parenteral nutrition.
* Long-term corticotherapy ( over 6 months of therapy)
* Inability to keep the leg or the arm immobile for 3 min
* Patient not affiliated to a Social Security System
* Patient participating to another interventional study
* Pregnant patient or patient who desires pregnancy
* All situation that the physician estimated that is not compatible with the study
A Randomized Controlled Trial of Eculizumab in AQP4 Antibody-positive Participants With NMO (PREVENT Study)

The objectives of this time-to-event study were to assess the efficacy and safety of eculizumab as compared with placebo in participants with neuromyelitis optica spectrum disorder (NMOSD) who were anti-aquaporin-4 (AQP4) antibody-positive.


Eligibility Criteria:
Key Inclusion Criteria:

1. Male or female participants ≥ 18 years old.
2. Diagnosis of NMO or NMOSD.
3. AQP4 antibody seropositive.
4. Historical relapse of at least 2 relapses in the last 12 months or 3 relapses in the last 24 months with at least 1 relapse in the 12 months prior to the screening.
5. Expanded Disability Status Scale score ≤ 7.
6. If a participant entered the study receiving immunosuppressive therapy (IST) for relapse prevention, the participant must have been on a stable maintenance dose of IST(s), as defined by the treating physician, prior to Screening and must have remained on that dose for the duration of the study, unless the participant experienced a relapse.
7. Female participants of childbearing potential were to have a negative pregnancy test (serum human chorionic gonadotropin). Participants were required to practice an effective, reliable, and medically approved contraceptive regimen during the study and for up to 5 months following discontinuation of treatment.

Key Exclusion Criteria:

1. Use of rituximab within 3 months prior to Screening.
2. Use of mitoxantrone within 3 months prior to Screening.
3. Use of intravenous immunoglobulin within 3 weeks prior to Screening.
Study Evaluating the Pharmacokinetics of the Potential Drug Interaction Between HCV-796 and Desipramine

To evaluate the potential pharmacokinetic (PK) interaction of multiple oral doses of HCV-796 and a single dose of desipramine when coadministered to healthy subjects.


Eligibility Criteria:
Inclusion Criteria:

* Healthy as determined by the investigator on the basis of medical history, physical examination, clinical laboratory test results, vital signs, and 12-lead ECG.
An Open Label Phase I Dose Escalation Trial of Intravenous BI 6727 (Volasertib)in Combination With Oral BIBW 2992 (Afatinib) in Patients With Advanced Solid Tumours

The primary objective of the current study is to investigate the Maximum Tolerated Dose (MTD) in terms of safety and tolerability of the combination of BI 6727 with BIBW 2992, in patients with advanced or metastatic solid tumours. Dosages of both BI 6727 and BIBW 2992 will be varied to establish the MTD of the combination. Two combination treatment schedules will be tested, the MTD of each combination will be determined.

Secondary objectives are the exploration of pharmacokinetics, overall safety and preliminary efficacy.


Eligibility Criteria:
Inclusion criteria:

* Patients with histologically or cytologically confirmed diagnosis of advanced, non resectable and/or metastatic, relapsed or refractory solid tumours not amenable to standard therapy and for whom no therapy of proven efficacy exists
* Eastern Cooperative Oncology Group performance score 0 - 2
* Recovery from clinically significant toxicities from previous systemic anti-cancer therapies or radiotherapy

Exclusion criteria:

* Serious illness, concomitant non-oncological disease or mental problem considered by the investigator to be incompatible with participation to the trial
* Known hypersensitivity to the trial drugs or their excipients
* Treatment with any other investigational drug or active participation in any other interventional trial within 28 days before first administration of trial drug(s) or concomitantly with this trial
* Major surgery or radiotherapy within 28 days before start of therapy or concomitantly with this trial
* Systemic anti-cancer therapy within 28 days before start of therapy or concomitantly with this trial
* Requirements for treatment with any of the prohibited concomitant medications
* Active infectious disease or known HIV I/II infection
* Gastrointestinal disorders that may interfere with the absorption of the study drug or chronic diarrhoea
* Active brain metastases
* History or presence of cardiovascular abnormalities deemed clinically relevant by the investigator
* Cardial left ventricular function with resting ejection fraction \< 50%
* Inadequate hepatic, renal and haematologic organ function
* QT prolongation deemed clinically relevant by the investigator
* Active alcohol or drug abuse
* Women of childbearing potential and men who are able to father a child unwilling to use a medically acceptable method of contraception during the trial and 28 days thereafter
* Pregnancy or breast-feeding
* Patients unable to comply with the protocol
* Patients with known pre-existing interstitial lung disease
Clinical Efficacy and Safety Evaluation of Co-administered HGP0904, HGP0608 and HGP0816 in Patients With Hypertension and Dyslipidemia

A phase 3 study to evaluate efficacy and safety of Co-administered HGP0904, HGP0608 and HGP0816 in Patients with Hypertension and Dyslipidemia

This study is designed as a multi-center, double-blinded, randomized, phase 3 clinical trial to evaluate the efficacy and safety of Co-administered HGP0904, HGP0608 and HGP0816 in Patients with Hypertension and Dyslipidemia

Eligibility Criteria:
Inclusion Criteria:

1. 19 ≤ age ≤ 75
2. at Visit 1 1) BP: sitDBP ≥ 90mmHg 2) Cholesterol : LDL-C ≤ 250mg/dL, TG \< 400mg/dL
3. at Visit 2 : after TLC (after 4weeks) 1) BP: 80 mmHg ≤ sitDBP \< 110mmHg 2) Cholesterol : following risk category (Cardiovascular Risk category) A : CHD risk factor 0 - 1, 160mg/dL ≤ LDL-C ≤ 250mg/dL B①: CHD risk factor≥2 and 10 year risk \<10%, 160mg/dL ≤ LDL-C ≤ 250mg/dL B②: CHD risk factor≥2 and 10 year risk =10-20%, 130mg/dL ≤ LDL-C ≤ 250mg/dL C : CHD/CHD risk equivalents\* or 10 year risk\>20 ,100mg/dL ≤ LDL-C ≤ 250mg/dL 3) TG \< 400mg/dL 4. Patients understood the contents and purpose of this trial and signed informed consent form

Exclusion Criteria:

1. At Visit 1, BP difference SBP ≥20mmHg or DBP ≥10mmHg
2. Tolerance or Hypersensitivity Angiotensin II receptor blocker or HMG-CoA. reductase inhibitor, Calcium channel blocker(dihydropyridine) or Multi-drug allergy
3. Fibromyalgia, myopathy, rhabdomyolysis or acute myopathy or medical history of adverse effect to statin
4. CPK normal range ≥ 3times
5. Uncontrolled primary hypothyroidism(TSH normal range ≥ 2 times)
6. Renal disease or suspected renal disease (Scr ≥ 2mg/dL, AST or ALT≥2 times)
7. Active gout or hyperuricemia(at Visit 1, uric acid \> 9mg/dL)
8. IDDM or uncontrolled diabetes mellitus (HbA1c\>9%)
9. ventricular arrhythmia
10. medical history

    * severe cerebrovascular disease within 6 months (cerebral infarction, cerebral hemorrhage), hypertension
    * encephalopathy, transient cerebral ischemic attack(TIA)
    * severe heart disease(heart failure of NYHA class III-IV), valvular disease of heart or myocardial infarction and unstable angina
    * angioplasty or coronary artery bypass graft(CABG) surgery within 6months
Clinical Characteristics and Risk Factors for In-Hospital Mortality in Surgical Patients With Abdominal Sepsis

A retrospective study of sepsis patients with abdominal infections who underwent abdominal surgery was conducted in an attempt to reveal the epidemiological characteristics of sepsis after abdominal surgery, risk factors, and to analyze the prognosis of the patients, to reveal indicators of predictive value for the prognosis of patients with sepsis, with a view to providing certain evidence for optimizing the perianesthesia management of patients with sepsis.

Background and Aims: Abdominal sepsis refers to a severe and potentially life-threatening condition characterized by the presence of infection, inflammation, and tissue damage within the abdominal cavity. Glucocorticoids (GCs) play an important role in regulation of the host immune and inflammation responses involved in sepsis and surgery. This study aimed to investigate the potential impact of intraoperative GCs administration on the clinical outcome of surgical patients with abdominal sepsis.

Methods: This retrospective cohort study included a 1:1 propensity score-matched cohort of surgical patients afflicted with abdominal sepsis at 2 medical centers from January, 2008, through December, 2022. Patients were classified into low-GCs, high-GCs, and non-GCs groups according to the dosage of steroids used intraoperatively, and in-hospital mortality was designated as the primary outcome.

Eligibility Criteria:
Inclusion Criteria:

* Meeting the Sepsis 3.0 criteria ;
* Patient's age ≥ 18 years;
* Emergency or elective abdominal surgery.

Exclusion Criteria:

* History of severe cardiopulmonary, hepatic, renal, or other organ damage;
* Preoperative presence of infection other than abdominal;
* Unplanned secondary surgery；
* Receiving preoperative glucocorticoid therapy.
Effects of Exercise and 5-HTP on Cortisol Levels

It has been shown that 5-HTP stimulates cortisol levels in plasma and saliva. Similarly, it has been shown that intense exercise stimulates an increase in plasma and salivary cortisol levels. The purpose of this study is to examine the combined effects of 5-HTP + intense exercise on plasma and salivary cortisol levels.


Eligibility Criteria:
Inclusion Criteria:

* Healthy men and women, not taking medication known to alter glucocorticoid metabolism

Exclusion Criteria:

* Diabetes
* Obesity
* Hypertension
* Coronary artery disease
* Psychiatric disorders
* Any disease preventing them from participating in intense exercise
* Subjects taking medication known to interfere with glucocorticoid metabolism will be excluded
Study of the Long Term Safety of Serlopitant for the Treatment of Pruritus (Itch)

Study of the long term safety of serlopitant for the treatment of pruritus in adults.


Eligibility Criteria:
Inclusion Criteria:

* Male or female, age 18 years or older at consent.
* Pruritus associated with prurigo nodularis, atopic dermatitis, or psoriasis.
* Female subjects of childbearing potential must be willing to practice highly effective contraception until 5 weeks after last dose of study drug.
* Willing and able to comply with study visits and study related requirements including providing written informed consent.

Exclusion Criteria:

* Malignancy within 5 years prior to enrollment (exception for non-melanoma cutaneous malignancies).
* Any known major psychiatric diagnosis, such as major depressive disorder, bipolar disorder, schizophrenia, psychotic disorder, intellectual disability, severe alcohol use disorder, which may confound the assessment of serlopitant safety or efficacy, or interfere with the subject's ability to comply with protocol-mandated activities, within 3 years prior to enrollment.
* Untreated or inadequately treated thyroid, adrenal, or pituitary nodules or disease, or history of thyroid malignancy; or the prescense of any medical condition or disability, that could interfere with the assessment of safety in this study or compromise the safety of the subject.
* Investigational therapy within 4 weeks or 5-half-lives prior to enrollment (whichever is longer) or expected participation in another clinical study involving an investigational product or device during the subject's participation in this study.
* Treatment with other neurokinin-1 receptor (NK1-R) antagonists (e.g., aprepitant, fosaprepitant, rolapitant) within 4 weeks.
* Treatment with strong cytochrome P450 3A4 inhibitors within 4 weeks.
* Currently pregnant or breastfeeding or planning to become pregnant during the study.