cyrilzakka/clinical-trials huggingface dataset:
the Effect of Diane-35 Pretreatment on In-vitro Fertilization Outcome for Patients With Polycystic Ovary Syndrome

Polycystic Ovary Syndrome is the most common endocrine disorder in women, is estimated to affect more than 5% of the population and is associated with chronically elevated serum androgen concentrations.Evidence suggests that polycystic ovary syndrome has a negative impact on pregnancy outcomes, with an increased risk of gestational diabetes, hypertensive disease during pregnancy,and preterm birth,which is partially related with the hyperandrogenic environment.Diane-35 has been proved to be the most effective anti-androgenic drug.At present, there is no direct evidence that Diane-35 has a positive effect on the clinical outcome of polycystic ovary syndrome patients undergoing In-vitro fertilization/Intracytoplasmic sperm injection.


Eligibility Criteria:
Inclusion Criteria:

* diagnosed polycystic ovary syndrome patients according to Rotterdam criteria
* with hyperandrogenism and/or clinical hyperandrogenic manifestations
* no other oral contraceptives treatment for at least 3 months before this experiment
* no any other assisted reproductive therapy
* accompanied with fallopian tube and/or male factors
* normal hepato-/nephro- function

Exclusion Criteria:

* oral contraceptive pills contraindications, eg.Deep Venous Thrombosis
* smoking, drunk
* exclude other infertile factors, eg.endometriosis, abnormal thyroid function, etc.
Efficacy and Safety of BNP105 in the Treatment of Recurrent Aphthous Stomatitis

The purpose of this study is to evaluate the efficacy and safety of BNP105 in the treatment of recurrent aphthous stomatitis.


Eligibility Criteria:
Inclusion Criteria:

* Ability to confirm voluntary participation and agree to all trial purposes by signing and dating the informed consent forms;
* Age greater than or equal to 12 years;
* One minor recurrent aphthous stomatitis with onset of symptoms within 48 hours;
* Moderate to severe baseline pain, with VAS ≥ 60 mm (EVA scale 0-100 mm).

Exclusion Criteria:

* Any clinical findings that, in the judgment of the investigator, may interfere with the safety of research participants;
* Participants diagnosed with: Behcet's disease, rheumatoid arthritis, systemic lupus erythematosus, reactive arthritis, Reiter's syndrome, Crohn's disease, ulcerative colitis);
* Participants with diseases that affect healing (e.g. diabetes);
* Immunocompromised participants;
* Participants with aphthous herpetiform ulceration or major aphthous ulceration;
* Participants using medication to treat oral ulcerations (systemic or local);
* Participants who used analgesics or anti-inflammatory drugs in the 6 hours prior to the beginning of the study;
* Participants who used systemic antibiotics in the 2 weeks prior to the beginning of the study;
* Participants using medications that can confuse pain assessment (psychotropics, antidepressants and sedative-hypnotics), except when on a stable dose for at least 30 days prior to the screening visit, and the dose cannot be changed during the clinical trial;
* Participants with current smoking habits.
* Participants who are pregnant, breastfeeding or planning to get pregnant or female participants with the potential to become pregnant who are not using a reliable method of contraception;
* Known hypersensitivity to the formula components used during the clinical trial;
* Participants with current or medical history of cancer in the last 5 years;
* Participants who participated in other research protocol in the last 12 months, unless the investigator judges that there may be a direct benefit to it.
Effects of Recurrent PE on Women and Offspring

The purpose of this study is to evaluate the risk factors of recurrent preeclampsia and compare the short-term and long-term adverse outcomes of women and their offspring.

The investigators collected women delivered twice in a row in our hospital. The investigators divided these pregnant women into three groups. Women in the first group did not complicate preeclampsia at both deliveries; Women in the second group complicated preeclampsia at the first delivery or at the second delivery; women in the third group complicated preeclampsia at two deliveries. The investigators explore the risk factors of recurrent preeclampsia and measure blood pressure, blood lipids, thyroid function, glycosylated hemoglobin, ALT, AST, et al. in one year, three years, and five years after the second delivery.

Eligibility Criteria:
Inclusion Criteria:

* women with at least twice of delivery history

Exclusion Criteria:

* women with chronic hypertension
Effects of Deep Breathing Exercise on Pulmonary Function, Perceived Stress and Physical Fitness Among Healthy Smokers

Effects of deep breathing exercise on pulmonary function, perceived stress and physical fitness among healthy smokers.

Smoking is injurious to health as cigarette contains harmful substances that cause different life threatening diseases, like bronchitis, asthma, chronic obstructive pulmonary disease (COPD), cardiovascular diseases etc. During normal breathing, oxygen is supplied to the body through blood circulation. But, in smokers, carbon monoxide (CO) is supplied to body instead of oxygen, resulting in respiratory issues, like breathlessness and coughing, in acute stages . Smoking decreases lung capacity, as it contains acidic substances which start damaging the lining of the bronchi and bronchioles due to which they become inflamed and infected, resulting into coughing, shortness of breath and chest pain that leads towards chronic bronchitis. This study will contribute our young smokers as they are adherent to smoking and its difficult for them to quit smoking. as their physical activity is limited, individuals under stress condition and with pulmonary complications so impact of this research is that along with helping smokers to quit smoking also applying alternative strategies to minimize complication and improve quality of life. and these alternative strategies include such activities that performed easily at home and do not require much effort or no need to go to gym or any other place to perform these exercises.

Eligibility Criteria:
Inclusion Criteria:

* Only Male Healthy Smoker.
* Age: 20 - 30 years.
* Participants had a minimum smoking history of 5 years.
* Subject without any chronic pulmonary complication.

Exclusion Criteria:

* Smokers with any pulmonary disease, acute infections, other systemic disease.
* Chest deformity or any disability.
* History of any surgery.
* Not willing to participate.
Comparison of Effects of Scalp Block and Intravenous Esmolol on Hemodynamic Response Following the Skull Pins Application for Elective Supratentorial Craniotomy

The goal of this clinical trial is to compare hemodynamic response (MAP, SBP, DBP and HR) between scalp block and intravenous esmolol while skull pins application in patients undergoing elective supratentorial craniotomy under general anesthesia.


Eligibility Criteria:
Inclusion Criteria:

* Age 18-65 years old
* BMI 18-30 kg/m2
* American Society of Anesthesiologists (ASA) status I-III
* Elective supratentorial craniotomy under general anesthesia
* Required application of skull pins

Exclusion Criteria:

* Poor controlled hypertensive condition (Baseline BP ≥ 160/110 mmHg)
* Thrombocytopenia / Coagulopathy
* Preoperative atrioventricular block (More than 2nd degree AV block)
* Emergency surgery
* Posterior fossa / Intracranial aneurysm surgery
* Pregnancy
* Chronic use of pain control
* Contraindication to beta-blockers
* Allergy to the drugs used in the study
Local Anesthetic for Plateau Fractures

Subjects may receive an injection at the end of the surgery to fix their broken leg that may reduce their pain and hospital stay

Subjects will be randomized to bupivicaine or saline injection in the joint at the end of Open Reduction Internal Fixation of the tibial plateau fracture

Eligibility Criteria:
Inclusion Criteria:

* Age \>=18 year ,
* tibial plateau fracture undergoing Open Reduction and fixation"

Exclusion:

* allergy to bupivacaine
* Prolonged external fixator use
Combination of Serratus Anterior and Pectoral Nerve Blocks (PECS II) as Main Anesthetic Method in Breast Cancer Surgery

Aim of this study is to determine the success of combined serratus anterior and PECS-2 block as the main anesthetic method in breast cancer surgery and also to investigate the patient acceptability of this combination and its relationship with surgeon satisfaction.

Breast conserving surgery or mastectomy is applied in the surgical treatment of breast cancer. Axillary interventions range from sentinal lymph node biopsy to lymph node dissection. Clinically significant acute pain develops following breast surgery in 35% of patients.

Today, regional anesthesia is widely used as an opioid-sparing strategy in the treatment of acute postoperative pain. New fascial plane blocks have been developed as alternative or complementary techniques for chest wall analgesia, including pectoral nerve blocks (PECS1-2) and serratus plane block.

In order to reduce the risk of perioperative morbidity and mortality and to meet the patient demand, the demand for awake surgery is increasing in institutions.

Therefore, a prospective observational case series was conducted to explain the efficacy, patient acceptability, and surgeon satisfaction of combined serratus anterior and PECS-2 block as the main anesthetic method for breast cancer surgery.

Eligibility Criteria:
Inclusion Criteria:

* Patients between the ages of 18-80 and ASA I-III who will undergo unilateral breast cancer surgery will be included in the study.

Exclusion Criteria:

* Patients with previous breast surgery other than excisional biopsy,
* coagulopathy,
* bleeding disease,
* local infection at the injection site,
* history of local anesthetic allergy,
* psychiatric disease (depression, mania, schizophrenia or antipsychotic drug use),
* history of opioid use for more than 4 weeks
* Patients with body mass index (BMI) \>40kg/m2 and
* chest deformity (pectus excavatum and pectus carinatum) will be excluded from the study.
Study of microRNAs as a Diagnostic Tool for HCV-related Hepatocellular Carcinoma

The aim of this work is to study the role of circulating miRNAs in diagnosis of HCV related hepatocellular carcinoma.

Early diagnosis of hepatocellular carcinoma can significantly improve the overall survival of HCC patients, currently available diagnostic markers are still inadequate and limited by their low sensitivity and specificity. For instance, the gold standard marker, alpha-fetoprotein (AFP), has a false negative rate up to 40% for early stage of HCC. It is worthy to mention that the level of AFP was reported in a normal range of 25% of patients with advanced HCC. These discrepancies suggest the need of discovering new reliable diagnostic markers for patients with HCC. miRNAs are small endogenous, non-coding, ssRNA that are 21-30 nucleotides in length. As for the relationship between miRNA and HCC several studies have demonstrated that the aberrant expression of specific miRNA can be detected in HCC cells and tissues.

miRNAs expression profile analysis has allowed the characterization of 'identity' associated with each type of human cancer and this 'identity' is correlated with carcinogenesis, tumor progression, and response to tumor treatment.

Eligibility Criteria:
Inclusion Criteria:

* RNA extraction and quantitative Real-Time PCR analysis
* Diagnosis of HCV will be based on detection of anti-HCV antibodies
* Diagnosis of liver cirrhosis will be based on ultrasonography, biochemically and elastography when available
* Diagnosis of HCC will be based on ultrasonography, the typical criteria in triphasic multislice CT scan

Exclusion Criteria:

* HBV or autoimmune or metabolic liver disease
* serological evidence of human immunodeficiency virus (HIV) infection
* malignancy in other organs
* After intervention in treatment of hepatocellular carcinoma
Ultrasound-guided Genicular Nerve Block With Phenol for the Treatment of Chronic Pain Due to Knee Osteoarthritis

Osteoarthritis (OA) is one of the most frequent causes of chronic pain, often intense, debilitating and responsible for a large percentage of the elderly. The disease affects about 10% of adults and the knees are the most affected joints. The diagnosis of OA in the knee is predominantly clinical, and can be confirmed by radiological examination. Systemic drugs are indicated before invasive procedures, but pharmacological therapies may offer limited benefits. Thermal radiofrequency lesions of genicular nerves has been used to relieve chronic knee pain, as adjuvant therapy, but with high costs and low availability in the public system. The use of phenol for peripheral analgesic blocks has emerged as a good option and at low cost and can be used in any service of Pain Treatment. The aim of the study is to evaluate the efficacy of 6% phenol for ultrasound-guided genicular nerves neurolysis for the treatment of patients with chronic knee pain due to osteoarthritis.

METHODS: A prospective study will be carried out with 15 patients with chronic pain (more than 4 months) and diagnosis of arthrosis by imaging, with pain intensity greater than 4 (from zero to 10) that will be submitted to ultrasound-guided genicular nerves block. The test block will be performed with 0.25% -1,5 mL bupivacaine on each nerve. Patients who present pain improvement\> 50% will undergo neurolysis of genicular nerves with 1,5 mL of 7% phenol in each of the genicular nerves. After the procedure, the patients will be evaluated for 3 months in relation to the intensity of pain at rest and movement and duration of analgesia provided by the intervention, range of movements and functionality of the knee joint.


Eligibility Criteria:
Inclusion Criteria:

* Signature of the free, informed consent form
* Age over 18 years old
* Knee pain for more than six months without improvement with clinical treatment
* Clinical and imaging diagnosis (radiography) of knee osteoarthritis
* Moderate pain intensity (pain greater than 4, by the numerical scale).

Exclusion Criteria:

* Cognitive impairment or psychiatric disease
* Other causes of knee pain (trauma, complex regional pain syndrome)
* Puncture site infection
* Coagulopathy or use of anticoagulant.
Prevalence of Dissociative Disorders in Children

Schizophrenia beginning before 18 years is a clinical entity not well known because of its low incidence and difficulties in the clinical diagnosis.

However, in the investigators clinical practice, due to the specialization of the investigators service, the investigators are led to hospital to receive important feel active of patients meeting the Diagnostic and Statistical Manual of Mental Disorders IV text revision (DSM IV-TR) precose schizophrenia.

The work of us team on the theme of the relationship between Pervasive Developmental Disorders and precose Schizophrenia led us to hypothesize that a number of children in care in the medical and educational institutes, hospitals and day shelters therapeutic part-time symptoms of schizophrenia or a line real early diagnosis of schizophrenia undervalued or not diagnosed.

The main goal is to estimate the prevalence of dissociative disorders in a population of children in care institutions and medical education in child psychiatry in hospitals and others structures.


Eligibility Criteria:
Inclusion Criteria:

* 7 to 18 years
* Supported in the partner institutions of the study
* IQ\>35 on the certificate of orientation of the Maison Départementale des Personnes Handicapées (MDPH)
* Obtaining the agreement of parents and children

Exclusion Criteria:

* QI\<35 on the certificate file Guidance MDPH
* Children not speaking french
First in Human Study of an Anti-Toll-like Receptor 4 (TLR4) Monoclonal Antibody (NI-0101) in Adult Healthy Volunteers

The purpose of this study is to determine the safety, tolerability and distribution and elimination of a novel therapeutic drug when administered to Healthy Volunteers. In addition its effects on some inflammatory parameters will be measured in presence or absence of lipopolysaccharide stimulation.


Eligibility Criteria:
Inclusion Criteria:

* Healthy adults between 18 and 40 years old (inclusive) having a body mass index (BMI) between 18 and 30 kg/m2 (inclusive), able to adhere to study protocol requirements and having signed informed consent.

Exclusion Criteria:

* Any abnormal past or present clinically relevant medical history or any relevant abnormal laboratory parameters at screening that will prevent to consider the volunteers as healthy for the study.
Integrated Treatment for Youth With Mood Disorders

In an effort to understand the effects of evidence-based interventions on children and adolescents, the aims of this study are to:

1. evaluate the feasibility of utilizing wearable devices to track health information (i.e., sleep, physical activity);
2. evaluate the effectiveness of evidence-based intervention components on mood and interpersonal functioning, family engagement, and sleep and physical activity level outcomes.


Eligibility Criteria:
Inclusion Criteria:

* Children and adolescents between the ages of 10 and 18 years;
* Diagnosed with a primary depressive or bipolar disorder;
* Admitted to the Child and Adolescent Integrated Mood Program (CAIMP) at Mayo Clinic.

Exclusion Criteria:

* Individual's not eligible for admission to the Child and Adolescent Integrated Mood Program (CAIMP)at Mayo Clinic.
Dutch National Prospective EMR Cohort

A Prospective Study: Longterm Follow Up until S2 (2nd surveillance) at 18 months after EMR for Large Flat/Sessile Colonic Polyps.


Eligibility Criteria:
Inclusion Criteria:

* Flat or sessile polyp morphology (Paris classification 0-IIa/b/c, Is)
* Polyp size \>20 mm
* Therapy: EMR
* Age \> 18 years old
* Written informed consent

Exclusion Criteria:

* Participation in a competing study, such as the "CLIPPER trial" (registration number: NL62949.091.17).
A Novel Assay to Quantify Treatment Response in Cystic Fibrosis (CF)

Inflammation is present in the Cystic fibrosis (CF) airway from the time of infancy, and worsens with the onset of chronic infection. Therapies with proven benefit are associated with decreased airway inflammation. Thus, sensitive and reproducible biomarkers of airway inflammation have long been sought as a necessary component to improved clinical care and to facilitate therapeutic trials for CF. FEV1, the standard outcome measure in CF, is recognized as an insensitive outcome measure. the investigators have identified a panel of 10 genes which sensitively predict resolution of pulmonary inflammation, in response to therapy of an acute pulmonary exacerbation. With the goal of yielding a technically simple but unique CF biomarker assay, the investigators have tested whether proteins signified by these genes show large changes in expression following treatment of acute pulmonary exacerbations. Protein quantifications are among the most common measurements performed in clinical laboratories around the world. Based on preliminary findings that changes in white blood cell proteins mirror changes seen in the genes, the investigators propose to identify top candidate proteins, from the investigators gene panel, which change in response to exacerbation therapy. Once identified, these proteins will be quantified directly with a new blood test which is inexpensive and simple to perform. The investigators propose to validate this blood test in a single site trial. If successful, this proposal will yield a biomarker assay that will be available to validate in a multi-site trial and provide unique insights into mechanisms that regulate white blood cell activation and recruitment in CF lung disease.


Eligibility Criteria:
Inclusion Criteria:

1. Documented diagnosis of CF.
2. Age 18 years old or greater.
3. Presentation at the start of treatment for a pulmonary exacerbation of CF.
4. Ability to perform reproducible Pulmonary Function Tests and produce sputum.
5. Willingness to comply with study procedure and willingness to provide written consent.

Exclusion Criteria:

1. Presence of a condition or abnormality that, in the opinion of the Principal Investigator (PI), would compromise the safety of the patient or the quality of the data.
2. Use of systemic steroids
Timing of Primary Surgery for Cleft Palate

This trial is a randomised controlled trial with a parallel design taking place in centres across the UK, Scandinavia and Brazil.

650 infants with a diagnosis of isolated cleft palate who are considered medically fit for operation at 6 months, and who meet the inclusion criteria, will be included in the trial and randomised to receive either:

* Surgery at age 6 months, OR
* Surgery at age 12 months.

The main objective is to determine whether surgery for cleft palate, using a Sommerlad technique, at age 6 months, when compared to surgery using the same technique at age 12 months, improves velopharyngeal function at age 5 years. All infants will be followed up at age 12 months, 3 years and five years for the assessment of the primary outcomes( at age 5 years) and secondary outcomes.

Infants will be followed up at age 12 months, 3 years and five years. At each visit the following will be assessed:

Age 12 months

* Speech development (canonical babbling)
* Audiological assessments
* Growth

Age 3 years

* Speech development
* Audiological assessments

Age 5 Years

* Speech development
* Audiological assessments
* Dentofacial development (Soft Tissue ANB and Maxillary arch constriction score using modified Huddart Bodenham scoring)

Eligibility Criteria:
Inclusion Criteria:

* Infants with isolated cleft palate
* Medically fit for operation at 6 months, corrected for gestational age
* Written informed proxy consent
* One parent/carer a native language speaker in the country of residence

Exclusion Criteria:

* Consent not obtained
* b. Infants with syndromic cleft palate (except Van der Woude syndrome, which can be included if hearing is not affected) or severe developmental delay
* Congenital sensorineural hearing loss or middle ear anomalies;
* Variation in the anatomical presentation is such that the surgeon who will perform the procedure considers that one stage closure with the Sommerlad technique would be inappropriate;
* Submucous cleft palate (defined by the classical triad of signs, bifid, uvula, bony defect of the hard palate, muscular diastasis, as described by Jensen et al (1988).
* Where the language spoken at home is not the majority language in the country of residence.