cyrilzakka/clinical-trials huggingface dataset:
Systemic Inflammatory Indices as a Non-invasive Grading Modality for Endometriosis

Endometriosis (EMs) is one of the commonest chronic inflammatory disorder affecting women and is characterized by the presence and growth of endometrial-like glandular epithelial and stromal cells outside the uterus leading to multiple clinical symptoms affecting patients quality of life and fertility with high recurrence rate . The systemic immune inflammatory index (SII) and systemic inflammatory response index (SIRI) are documented as prognostic serum biomarker in many kinds of cancer and for the need and outcomes of adjuvant therapies for various cancers .


Eligibility Criteria:
Inclusion Criteria:

* Women with clinical manifestations suggestive of having EM;
* Women who was professionally diagnosed;
* Women who was diagnosed by radiologic workup;
* Women were free of exclusion criteria.

Exclusion Criteria:

* Women with EM and were maintained on treatment or underwent operative interference during the last three months;
* Patients had autoimmune diseases, maintained on immunosuppressive therapy for any indication;
* Women with cancer elsewhere in the body or receiving adjuvant therapies for cancer;
* Patients receiving therapies for viral disorders especially COVID;
* Patients refusing to undergo the exploratory laparoscopy.
An Efficacy Study of Chlorhexidine Mouthwashes

The aim of this study is to compare subject gingival health after 6 weeks of twice daily use of a non-alcohol or alcohol containing mouthrinse and brushing compared to brushing only.


Eligibility Criteria:
Inclusion Criteria:

* Good general health with (in the opinion of the investigator) no clinically significant and relevant abnormalities of medical history or oral/ dental examination.

  5. a) Good oral health in the opinion of the investigator (allowing mild to moderate gingivitis to meet entry criteria).

  b) A minimum of 20 permanent gradable teeth at screening. (Gradable teeth are those where restorative materials cover less than 25% of the tooth surface graded).

  c) Mild to moderate gingivitis present at the screening visit in the opinion of the investigator.

  d) Positive response to bleeding on brushing exercise at screening visit. e) A total of 20 bleeding sites or greater at baseline visit.

Exclusion Criteria:

* Known or suspected intolerance or hypersensitivity to Chlorhexidine or other study materials (or closely related compounds) or any of their stated ingredients.
* 5. a) Current or relevant history of any serious, severe or unstable physical or psychiatric illness or any other medical condition (e.g. Diabetes Mellitus) that would make the subject unlikely to fully complete the study or any that increases the risk to the subject or undermines the data validity.

  b) Subjects requiring prophylactic antibiotic treatment prior to dental therapy.

  c) Use of concomitant medication that, in the opinion of the investigator, might interfere with the outcome of the study or increases the risk to the subject (eg: phenytoin, calcium antagonists, cyclosporine, warfarin, antibiotics, immuno-suppressants).

  d) Use of antibiotics within two weeks prior to the screening visit or throughout the study.

  e) Use of any systemic medication which would have an effect on gingival conditions within 14 days of gingival examinations (eg: ibuprofen or aspirin therapy) 6. a) Have current active caries b) More than 3 pockets with 5mm or over. c) Excessive calculus present that interferes with the probing examination for Gingival Index.

  d) Other severe oral/ gingival conditions (e.g. Acute Necrotizing Ulcerative Gingivitis) that may compromise the study or the subjects in the opinion of the investigator or gingivitis examiner.

  e) Medical conditions which may directly influence gingival bleeding. f) Restorations in a poor state of repair. g) Orthodontic appliances anterior cosmetic restorations and veneers. h) Enamel pitting/irregularities. 7. Subjects using chewing tobacco, pan, pan-masala, gutkha or other chewing tobacco products or subjects who have quit using any of those within the past six months prior to screening.

  8. b) An employee of any toothpaste manufacturer or their immediate family.
Effectiveness of a Training Program for Parents of Babies in Their First Year of Life to Achieve Motor Milestones

this study compares motor development of two groups of healthy term babies at the end of their first year of life. Parents of the intervention group have received a training program consisting in advices about correct positions, stimuli, how to play or how to carry their babies. The purpose of this study is to know if motor development can be improved by the environment.

Infants in both groups are recruited by the principal investigator at the hospital within two to three days after birth. An initial assessment was carried out at 2 months of age.

Intervention group:

1. Four training sessions (before the baby is 1 month old, at 3 months, at 6, and at 9 months old) teaching the main motor milestones to get in the next 3 months and how to help infants with the correct stimuli, positions or plays; triptychs containing the main points explained at the session and links to short videos about the given bits of advice.
2. Three evaluations of motor milestones at 9, 12, and 15 months old.

Control group:

1. Three evaluations of motor milestones at 9, 12, and 15 months old.

Eligibility Criteria:
Inclusion Criteria:

* Healthy-term infants
* Male and female
* Apgar score of at least 7 in the first minute and at five minutes.
* Natural or cesarean birth
* Absence of congenital malformations or orthopedic injury
* Absence of known congenital or genetic pathology
* Normal neurological medical examination of the newborn at hospital discharge.

Exclusion Criteria:

* Newborns who have required hospitalization before being enrolled.
* Multiple births
Nab-paclitaxel Based Regimens VS Paclitaxel Based Regimens in Neoadjuvant Treatment for TNBC

To evaluate the efficacy and safety of P nab-paclitaxel combined with carboplatin versus paclitaxel combined with carboplatin followed by epirubicin and cyclophosphamide in the neoadjuvant treatment of triple negative breast cancer.


Eligibility Criteria:
Inclusion Criteria:

* Female, aged ≥ 18 yrs and ≤70 yrs；
* Histological confirmation of Unilateral primary invasive breast cancer, cT2-4NanyM0, planning to receive neoadjuvant chemotherapy；
* The expression of ER\<10%，PR \<10% and Her-2 negative by immunohistochemical, if HER2 expression ++, further FISH test confirmed no amplification of Her-2 gene；
* ECOG performance status 0-1；
* LVEF≥55%；
* Bone marrow function: neutrophils ≥ 1.5×109/L, platelets ≥ 100×109/L, hemoglobin ≥ 90 g/L；
* Liver and renal function：Serum creatinine ≤ 1.5x ULN；Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5x ULN；Total bilirubin ≤ 1.5x ULN or when patients with Gilbert's syndrome ≤ 2.5x ULN；
* The patient has good compliance with the planned treatment, understands the research process of the study and signs a written informed consent form.

Exclusion Criteria:

* Cytotoxic chemotherapy, endocrine therapy or radiation therapy for any reason；
* New York Heart Association (NYHA) score identifies patients with heart disease above grade II (including grade II)；
* Patients with severe systemic infections or other serious illnesses；
* Patients known to be allergic or intolerant to chemotherapeutic drugs or their excipients；
* Combined with other malignant tumors or had malignant tumors other than breast cancer in the past 5 years, except for cervical carcinoma in situ and non-melanoma skin cancer that have been fully treated；
* Women of childbearing age who are pregnant or lactating and who refuse to take appropriate contraceptive measures during the trial；
* Participated in other experimental studies within 30 days before the first dose of study drug administration
* Researchers judged patients who were unsuitable for this study.
BP101 for Adults With Female Sexual Dysfunction

This study is to confirm efficacy and safety of study drug BP101 in female patients with with decrease or loss of sexual desire, which is equal to acquired generalized hypoactive sexual desire disorder (HSDD). Patients will be randomized in 1:1 ratio to either BP101 or placebo arms.


Eligibility Criteria:
Inclusion Criteria:

* Women aged from 21 to 50 years old, who have signed informed concent, with a regular menstrual cycle (STRAW stages -5 to -3).
* Decrease or loss of sexual desire (ICD-10 code: F-52.0) corresponding to the diagnosis of acquired generalized hypoactive sexual desire disorder (HSDD) according to Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM4), criteria.
* Current HSDD episode lasting not less than 24 weeks.
* Not less than 15 scores according to the FSDS-R (Distress) Total Score.
* Stable monogamous relationship with one sexually active male sexual partner lasting at least a year. The partner is physically available not less than 50% of time during a month.
* Consent to attempt to have a sexual intercourse at least twice a month, if she has a desire.
* Consent to complete a diary every day during the screening period and assessment of the baseline state (in this period diary records must cover ≥80% days), during the therapy and subsequent follow-up.
* Consent to use adequate methods of contraception throughout the study.

Exclusion Criteria:

* Any prohibited treatments.
* Other mental disorders or psychiatric diseases.
* Diagnosed Decrease or loss of sexual desire (HSDD) is situational (reactive) or lifelong.
* Score ≥ 20 according to the Beck Depression Inventory during the screening. Patients with 16 to 19 scores according to Beck's inventory may be included in the study unless, in the investigator's opinion, an actual depressive disorder is observed in the patient.
* Inflammatory diseases of pelvic organs, infections of the genitourinary system, cervicitis, interstitial cystitis, vulvodynia or severe atrophy of the vaginal epithelium, precluding normal sexual activity.
* Surgical interventions (other than cosmetic surgeries) on reproductive organs in past medical history (ovariectomy, hysterectomy, obvious scars from childbirth-related perineal stitches, etc), resulting in pain/dyspareunia, and/or precluding sexual contacts, and/or requires hormonal replacement treatment, and/or lead to the loss of sensibility while sexual contact.
* Pregnant and nursing women or non-lactating women during the first 12 months after childbirth.
* Consumption of more than 5 portions of alcoholic drinks per week or alcohol addiction, drug addiction or drug abuse in the past. One portion of an alcoholic drink means 360 ml of beer, 120 ml of wine or 30 ml of a strong alcoholic drink.
Evaluation of the Accuracy of Full Digital Workflow for Guided Implant Surgery Using the R2 Gate Software

The primary aim of the present study is to compare the accuracy of a full digital workflow for dental implants insertion to a partially digital workflow, for a limited edentulous space (1 to 3 dental units), in the maxilla or mandible.

Improvements of dental digital technologies are nowadays enabling clinicians to take the digital impressions of the dental arches, therefore avoiding the use of conventional impression materials. Digital impression procedures are claimed to be an approach to improve the accuracy of dental restorations by minimizing the error prone to conventional impression and gypsum model casting, enabling a high degree of standardization. Patients often prefer intraoral scan when compared to the traditional impression. Digital impression is also recommended when patients have remaining teeth that are extremely mobile or misaligned, due to the risk of exfoliation during the conventional impression procedure.

Despite its poor scientific and clinical evidence, the use of digital technologies into the daily practice registers a rapidly growing.

The precision of digital impressions depends on two different parameters: the resolution of the optical scanning system, and the precision of the matching algorithm which may significantly influence the precision of full arch scans. In order to minimize the effect of matching artifacts, only small parts of the dental arch in close vicinity of the teeth are recommended to be scanned.

For prosthetic restoration purpose, several studies regarding the accuracy of digital vs analogue impression have been performed, but none comparing the accuracy of digital vs partially digital workflow for prosthetically driven guided dental implant insertion.

Eligibility Criteria:
Inclusion Criteria:

* Kennedy Class III partially edentulism with 3 or less missing teeth,
* Good general health with no contraindications for implant surgery,
* Acceptance of dental implant treatment,
* Acceptance of 1 or 2 CBCTs.

Exclusion Criteria:

* Limited bone volume with stadial bone graft requirement,
* Limited mouth opening (impossible to use the surgical stent),
* Parkinson disease (impossible to perform an accurate CBCT).
Ultrasound to Evaluate the Quadriceps Muscle Wasting

Intensive care unit acquired muscle weakness (ICUAW) is a common disease. After 7 days of mechanical ventilation, a quarter of patients develop an ICUAW responsible of a 15-20% of muscle loss. This is a serious pathology associated with high morbidity and mortality.

Clinical diagnosis of ICUAW is difficult and need a patient awoken. CT scan and Magnetic Resonance Imaging (MRI) are considered as "gold standards" to quantify and monitor changes in muscle mass. But these tools are not adapted to ICU patients.

Ultrasound (US) is an easy access tool at the bedside to assess muscle mass and does not expose the patient to additional radiation.

The objective of this study is to evaluate the correlation between US and CT scan to measure quadriceps muscle thickness of ICU patients.

As part of the monitoring of the neurological disease, brain CT scans are frequently performed. At the same time, an acquisition sequence centered on the quadriceps will follow the brain sequences. Up to three brain CT scans coupled with a quadriceps imaging will be performed between the day of admission and on the tenth day of hospitalization. An ultrasound of the quadriceps will be performed concomitantly. The thickness of the quadriceps is measured by an independent operator on CT and ultrasound images.

Eligibility Criteria:
Inclusion Criteria:

* Patient over 18 years admitted to intensive care for a severe brain injury (Glasgow \<8) and with a predictive duration of mechanical of at least 48hours

Exclusion Criteria:

* Pregnancy,
* Bilateral trauma of thighs,
* Coma induced by poisoning or by a metabolic disorder,
* Morbid obesity (BMI \> 35).
Effectiveness and Costs of Enhanced Cocaine Treatments

The study will evaluate the effectiveness, economic benefits, and costs of voucher reinforcement for cocaine and alcohol abstinence, additional counseling services, and their combination in a sample of cocaine dependent patients receiving outpatient treatment as usual in a community clinic.


Eligibility Criteria:
Inclusion Criteria:

* Enrollment in an intensive outpatient program (IOP) for no more than 1 month
* Current DSM-IV diagnosis of cocaine dependence (month prior to IOP treatment)
* 18-65 years of age
* Ability to provide names of informants to help locate subject for follow-up

Exclusion Criteria:

* IV heroin use in last year
* Acute medical/psychiatric diagnosis that precludes outpatient treatment
* Inpatient treatment for 6 weeks or more prior to IOP treatment
* Incarceration for 6 months or more prior to IOP treatment
Non-Invasive Ventilation in Pulmonary Edema

This randomized controlled trial is primarily aimed at assessing the rate of acute myocardial infarction with the two noninvasive ventilatory techniques, non-invasive intermittent positive pressure ventilation and non-invasive continuous positive airway pressure.

Objective: To determine whether the application of non-invasive intermittent positive pressure ventilation (n-IPPV) increases the incidence of acute myocardial infarction (AMI) in patients with acute respiratory failure (ARF) secondary to acute cardiogenic pulmonary edema (ACPE), as opposed to non-invasive continuous positive airway pressure (n-CPAP).

Background Both n-CPAP or n-IPPV are used to treat ACPE complicated by ARF. Two previous studies, however, report an increased rate of AMI associated with the use of n-IPPV.

Methods: Fifty-two patients with severe ARF consequent to ACPE were randomized to receive n-CPAP (n=27) or n-IPPV (n=25), both associated with standard medical therapy. Cardiac markers, electrocardiogram and clinical-physiological parameters were monitored at study entry, after 30 and 60 minutes, and every 6 hours for the first two days.

Eligibility Criteria:
Inclusion Criteria:

* rapid onset of the symptoms
* severe dyspnoea at rest
* respiratory rate \> 30 breaths per minute
* use of accessory respiratory muscles
* oxygen saturation (SpO2) inferior to 90% with an inspiratory oxygen fraction of 60% via a Venturi mask
* radiological findings of ACPE

Exclusion Criteria:

* acute ischemic heart disease (myocardial infarction, chest pain, ST elevation)
* hemodynamic instability (i.e. systolic blood pressure \< 90 with dopamine or dobutamine infusion ≥ 5 mcgr/Kg/min) or life-threatening arrhythmias
* need for immediate endotracheal intubation (respiratory arrest, bradypnea or gasping)
* inability to protect the airways
* impaired sensorium (i.e. unconsciousness or agitation)
* inability to clear secretions
* respiratory tract infection
* recent oesophageal/gastric surgery
* gastrointestinal bleeding
* facial deformities
* hematological malignancy or cancer with an Eastern Cooperative Oncology Group performance status ≥ 2
* chronic respiratory failure necessitating long-term oxygen therapy
* diagnosis of myocardial infarction, pulmonary embolism, pneumonia, exacerbation of chronic obstructive pulmonary disease, pneumothorax in the previous 3 months
* denial or refusal of intubation
* claustrophobia
* inclusion in other research protocols
12 Fractions Carbon Ion Radiotherapy for Localized Prostate Cancer

The arm of this study is to explore the optimal dose of 12 fractions of carbon ion radiotherapy for prostate cancer in our center.

The radiation dose of 51.6GyE in 12 fractions is currently widely used in Japan, and clinical studies of 51.6GyE/12Fx have also been carried out for SBRT. There are some differences in equipment and carbon ion treatment planning system used between Japan and our center. Therefore, we designed this phase I clinical study to explore the optimal dose of 12 fractions of carbon ion radiotherapy for prostate cancer.

Eligibility Criteria:
Inclusion Criteria:

* Pathologically confirmed adenocarcinoma of prostate
* Stage cT1-3N0M0 localized prostate cancer
* No lymph nodes or distant metastasis
* Age ≥ 45 and \< 85 years of age
* Karnofsky Performance Score ≥70
* No previous pelvic radiation therapy (RT)
* No previous prostatectomy
* No previous invasive cancer (within 5 years before the prostate cancer diagnosis)
* Ability to understand character and individual consequences of the clinical trial
* Willing to sign the written informed consent; Informed consent must be signed before the enrollment in the trial

Exclusion Criteria:

* No pathologically confirmed adenocarcinoma of the prostate
* Pelvic lymph node metastasis (N1)
* Distant metastasis (M1)
* Previous pelvic radiotherapy
* Previous prostatectomy
Evaluation of the Metastasis and Recurrence of Prostate Cancer

This study aims to use the new molecular probe 18F-PSMA for the diagnosis,staging ,recurrence monitoring and evaluation of the prostate cancer.By compared with the conventional imaging methods (whole body bone scintigraphy and MRI) and molecular imaging methods (11C-choline PET/CT),we hope to find the advantages of 18F-PSMA PET/CT in the diagnosis and metastases of prostate cancer, and lay the foundation for the further clinical transformation.

This study aims to use the new molecular probe 18F-PSMA for the diagnosis,staging ,recurrence monitoring and evaluation of the prostate cancer.By compared with the conventional imaging methods (whole body bone scintigraphy and MRI) and molecular imaging methods (11C-choline PET/CT),we hope to find the advantages of 18F-PSMA PET/CT in the diagnosis and metastases of prostate cancer, and lay the foundation for the further clinical transformation.And make some comparison with those 3 methods.

Eligibility Criteria:
Inclusion Criteria:

1. Patients with initial diagnosis of prostate cancer; 1）T2 stage: PSA\>20ng/ml, Gleason Score \>= 8; 2）T3 or T4 stage; 3）The imaging examination was negative or localized metastasis of the pelvic lymph node, but there was no distant metastasis of lymph nodes or bone and internal organs other than the pelvic cavity.
2. Patients with biochemical recurrent prostate cancer; 1）After the RRP surgery, the serum PSA was over 0.2 ng/ml in two consecutive sera; 2）After the radiotherapy: the lowest PSA is up to 2 ng/ml.
3. Patients with CRPC. 1）The serum testosterone is in the castration level (\< 50 ng/dL or \< 1.7 nmol/L); 2）The PSA is elevated 3 times in a row, the base value is increased by more than 50%, and the PSA \> 2ng/mL(the interval is one week); 3）The continuation of the anti-androgen drugs, flunamine was stopped for at least 4 weeks, and biglumide was suspended for at least 6 weeks; 4）Despite the continued standard androgen deprivation therapy, the PSA is still progressing.

Exclusion Criteria:

1. Patients who are unwilling to participate in the study or unwilling to sign the informed consent forms;
2. Patients who are critically ill, suffering from mental illness and cannot cooperate with the examination;
3. There are electronic implants, such as pacemakers and insulin pumps in the body, and magnetic metal foreign objects in the spot.
Efficacy of Pragmatic Same-day COVID-19 Ring Prophylaxis for Adult Individuals Exposed to SARS-CoV-2 in Switzerland

A study to assess, in a two-arm open-label cluster randomized clinical trial, the efficacy of a 5-day course of LPV/r treatment in preventing COVID-19 in asymptomatic individuals exposed to a SARS-CoV-2 documented index patient, compared to surveillance alone.


Eligibility Criteria:
Inclusion criteria:

1. Documented close contact with a person with either a PCR-confirmed SARS-CoV-2 or a positive rapid SARS-CoV-2 antigen test (as per standard of care).
2. Enrolment of the participant no more than 7 days since last contact with index case;
3. ≥ 16 years of age;
4. Informed consent as documented by signature (including parent's or legal guardian's signature if the participant is between 16 and 18 y.o.).

Exclusion criteria\*:

1. Fever (temperature \>38.0°C) and/or respiratory symptoms (cough, dyspnea) and/or new anosmia/ageusia;
2. Individuals with previous confirmed SARS-CoV-2 infection, dating within the last six months ;
3. Known impairment of liver function;
4. Known hypersensitivity to the study medications;
5. Use of any medications that are contraindicated with lopinavir/ritonavir using the website www.hiv-druginteractions.org/checker
6. Individuals on boosted protease inhibitor (other than LPV) or boosted elvitegravir as part of an antiretroviral therapy
7. Inability to be followed-up for the trial period
8. Documented vaccination against SARS-CoV-2

   * Where necessary, additional biological and clinical assessment will be performed, based on clinical judgement.
Comparison of Three Different Strategies to Prevent Propofol Induced Pain During Infusion

Propofol is a popular intravenous drug to induce anesthesia but it causes local pain with an incidence between 40 and 90%. Three different strategies to prevent propofol induced pain will be studied compared with placebo. Pain will be scored with a four-point scale.


Eligibility Criteria:
Inclusion Criteria:

Healthy adults (ASA 1-2) for scheduled surgery under general anesthesia with propofol

Exclusion Criteria:

* pregnant
* sedative or analgesic drug 24h before surgery
* allergy with drug used in the study
* difficulty of communication
* absence of informed written consent