cyrilzakka/clinical-trials huggingface dataset:
Efficacy and Safety of Omalizumab in Adults (18-70 Years) With Moderate to Severe Chronic Urticaria

This study evaluated the safety and efficacy of omalizumab in adult patients with moderate to severe chronic urticaria who exhibit IgE against thyroperoxidase.


Eligibility Criteria:
Inclusion criteria:

* Males or females from 18-70 years of age
* Body weight ≥ 20 kg and ≤ 150 kg and with a total serum IgE level ≥ 30 IU/mL and ≤ 700 IU/mL
* Specific serum IgE anti-TPO level ≥ 8.0 IU/mL, documented within 3 months prior to randomization or time of pre-screening
* Diagnosis of moderate to severe chronic urticaria
* Subject's current episode of chronic urticaria according to the European Academy of Allergology and Clinical Immunology/Global Allergy and Asthma European Network/European Dermatology Forum (EAACI/GA2LEN/EDF) guideline at the time of screening
* Current episode of chronic urticaria has not responded to the approved marketed dose of antihistamine for 2 weeks or longer
* Urticaria activity score (UAS) ≥ 0 at any of the 7 days of the first section of the screening period
* UAS7 ≥ 10 at the time of randomization

Exclusion criteria:

* Females of child-bearing potential or breast feeding
* Present or past medical conditions that could have interfered with the study results
* Randomized into any other omalizumab study or who had received omalizumab
* Received investigational drugs within 30 days of enrollment
Laparoscopic Versus Combined Laparoscopic and Hysteroscopic Repair of CS Niche

Uterine niche is a frequent condition in patients with a history of cesarean section. Many treatment methods have been described for repair of niche with varying effectivities. In conventional Laparoscopic approach, not all bleeding points and fibrotic area are resected, while conventional hysteroscopic one result in more wide defect with high risk of recurrence and cannot be used in large niche with low RMT. In this new Double approach (hysteroscopy and laparoscopy) technique, the benefit of both laparoscopy and hysteroscopy will be attained.

In all patient involved in the study, laparoscopic entry will be done, then adhesiolysis and creation of the bladder flap(dissection of the bladder from the uterine scar) then:

Group (I): Laparoscopic Excision of large cesarean scar niche:

Intentional perforation of the niche will be done using uterine sound and excision of the fibrotic edges then suturing the uterine incision using 2-0 absorbable suture.

Group (II): Combined hysteroscopic and laparoscopic repair without excision of large cesarean scar niche:

The investigators will do the hysteroscopic resection of the niche under laparoscopic guide to avoid perforation of the niche. After completion of the hysteroscopic approach, laparoscopic plication of the niche without opening it will be done using multiple interrupted 2-0 absorbable suture After suturing, the hysteroscopy will be introduced again to assess the repair The patient will be sent home the day after. They will be followed up after 3 and 6 months.

Checkup of CSD repair:

After 6 month of surgery both groups will be examined using sonohysterography to assess the changes in niche diameters

Core outcome sets:

* Enlargement of the residual myometrium thickness and reduction of postmenstrual bleeding will be measured at the 3-month and 6-month.
* Subsequent fertility outcome

Eligibility Criteria:
Inclusion Criteria:

History of cesarean section Postmenstrual and or intermenstrual spotting Large Cesarean scar niche, depth more than 50% of adjacent myometrial thickness (AMT).

Failed medical treatment Signed informed consent.

Exclusion Criteria:

A contraindication for a hysteroscopic niche resection Women with a positive pregnancy test. A contraindication for general or local anaesthesia. Coagulation disorders that lead to higher risks on bleeding or anticoagulant use.

A (suspected) malignancy, endometrial polyps, atypical endometrial cells, cervical dysplasia, hydrosalpinx that may communicate with the uterus.

Adenomyosis or leiomyoma (the International Federation of Gynecology and Obstetrics (FIGO) leiomyomia subclassification system Type 0, 1, 2, 3) or large leiomyomas causing the uterine cavity length to be ≥ 9 cm as examined by transvaginal ultrasound or MRI.

Endocrine disorders that interfere with the menstrual cycle. Irregular menstrual cycle (\>35 days or intercycle variation of 2 weeks or more).

Patients who are not willing to conceive before and/or after the hysteroscopic surgery.
Skeletal Muscle Effects of GH in Boys

The purpose of the study is to measure the functional effects of recombinant GH in skeletal muscle, in addition to growth promotion, in short prepubertal boys with either growth hormone deficiency or idiopathic short stature. Patients will be similarly short. The investigators will also compare these values in the short stature cohort to those obtained in testing performed in normally growing age-matched healthy control boys not on GH. The group on GH will be studied before and after 6 and 12 months of GH treatment.

Prepubertal boys with significant short stature (height SDS ≤-2.0) diagnosed with either GH deficiency or idiopathic short stature (ISS) who are identified as candidates for GH treatment will recruited. Subjects will have a battery of studies to assess skeletal muscle strength, agility, power and endurance, as well as assessment of body composition and energy expenditure before and after GH administration. GH (Somatropin) treatment at standard doses will be given as daily injections at bedtime. Subjects will be followed at three-month intervals per the clinical routine, when anthropometric measurements will be obtained. Baseline studies will be repeated at 6 and 12 months from initiation of treatment, each patient will serve as his own control pre and post GH.

A group of normally statured healthy boys will have the same testing as the study patients but without GH treatment to assess the impact of natural growth on the muscle measures above.

Eligibility Criteria:
Inclusion Criteria:

Short Stature Group

1. 30 boys between 6-11 years of age
2. Prepubertal
3. Short stature (height ≤ -2SDS) due to either GH deficiency or idiopathic
4. Stable treatment of other pituitary hormone deficiencies
5. Naïve to GH therapy, or GH discontinued at least 6 months prior to study

Normal Stature Group

1. 15 boys between 6-11 years of age
2. Prepubertal
3. Normal height (10th to 90th%)

Exclusion Criteria:

1. Actively growing brain tumors
2. Chronic medical conditions that could affect study outcomes
3. Long-term steroid use
4. Intense regular physical training programs or organized team sports
Identification of Specific Modulation Frequencies in Hepatitis B Carriers With and Without Hepatocellular Carcinoma

The propose of this study is to identification of a group of specific amplitude-modulated frequencies of low intensity electromagnetic fields that is associated with biofeedback upon exposure to in patients with hepatitis B carries with or without hepatocellular carcinoma.

Patients will be exposed by different specific amplitude-modulated frequencies of low intensity electromagnetic fields for 30 min. During the exposure, autonomic response with be recorded in order to identify biofeedback response. Differences in group of frequencies is expected in patients with hepatitis B carries with or without hepatocellular carcinoma.

Eligibility Criteria:
Inclusion Criteria:

* hepatitis B carriers patients
* hepatitis B carriers patients with hepatocellular cancer patients

Exclusion Criteria:

* other tumor types
* other hepatitis types
The Role of Loteprednol in Reducing Post-Intravitreal Injection Related Pain

Patients are already receiving an intravitreal injection as a standard of care, but they are consenting to receiving a loteprednol drop following the intravitreal injection. This clinical trial is studying the role of loteprednol (corticosteroid) in reducing pain following intravitreal injections for patients with age-related macular degeneration. As of now, there is no definitive pain management technique following intravitreal injections. Loteprednol is a corticosteroid widely used in ophthalmology to treat pain and inflammation, however, it has not been studied as a treatment for pain following intravitreal injections. Our overall goal is to manage pain to improve quality of care after intravitreal injections. Participants will be given either loteprednol, or artificial tears following one visit for an intravitreal injection to test how effective loteprednol is in pain reduction. Pain levels will be assessed by asking participants over the phone about their pain from a scale of 0 to 10 at three different times over a 1-week period. Artificial tear and medication usage will also be tracked over a 1-week period.

Patients are already receiving an intravitreal injection as a standard of care for age-related macular degeneration, but they are consenting to receiving a loteprednol drop following the intravitreal injection for the research study. Loteprednol is used as a part of regular medical care at the Vistar Eye Center following intravitreal injections but quantifying the magnitude of pain reduction has not been done yet. Additionally, as of now there is no definitive pain management technique following intravitreal injections. This clinical trial is studying the role of loteprednol (corticosteroid) in reducing pain following intravitreal injections for patients with age-related macular degeneration. Participants will be treated with either loteprednol, or artificial tears following one visit for an intravitreal injection at the Vistar Eye Center to test how effective loteprednol is in pain reduction. Pain levels will be assessed by asking participants over the phone about their pain from a scale of 0 to 10 at 2-hours, 1-day, and 1-week following the intravitreal injection. Intravitreal injections will be performed by the retina surgeon, and phone calls will be done with the research coordinator. Artificial tear and medication usage will also be tracked over a 1-week period.

Eligibility Criteria:
Inclusion Criteria:

* All patients must have age-related macular degeneration and be undergoing intravitreal injections for treatment as defined by a retina specialist.

Exclusion Criteria:

* Dementia
* Report baseline eye pain
* Use topical NSAIDs or steroids
* Patient under 18 years old
* History of corticosteroid responsive elevation in intraocular pressure
* Allergy to Loteprednol or Nepafenac
* Pre-existing chronic pain disorders
* Advanced Glaucoma
* Herpes zoster
* Allergy to local anesthetic or penicillin
* Patients unable to consent on own behalf
* Patients unable to communicate pain
* Pregnancy
* Incarceration
The Articulated Oral Airway as an Aid to Mask Ventilation

The Articulating Oral Airway (AOA) is a novel oral airway which actively displaces the tongue, allowing for a greater cross-sectional area for mask ventilation. The investigators hypothesize that, in patients with predictors for difficult mask ventilation, the AOA will be non-inferior to the Geudel oral airway in terms of expired tidal volumes.

Difficult mask ventilation (MV) is common in the obese population and can result in patient morbidity and mortality. The Articulating Oral Airway (AOA) is a novel oral airway which actively displaces the tongue, allowing for a greater cross-sectional area for MV. The investigators hypothesize that, while using the same ventilatory pressure in neuromuscularly blocked patients with predictors for difficult mask ventilation, MV with an AOA will not result in smaller expired tidal volumes than MV with a similarly sized Guedel oral airway (GDA). In other words, the AOA will be non-inferior to the GDA in terms of expired tidal volumes.

Eligibility Criteria:
Inclusion Criteria:

* Individuals demonstrating 2 or greater predictors of difficult mask ventilation (as listed below) who are scheduled for elective surgery with general anesthesia and asleep mask ventilation/orotracheal intubation utilizing long-acting neuromuscular blockade.
* Predictors of difficult mask ventilation i) Age \> 55 years ii) BMI \> 30kg/m2 iii) Beard iv) Lack of teeth v) History of snoring

Exclusion Criteria:

* Documented history of impossible mask ventilation
* Planned omission of mask ventilation ('rapid-sequence induction,' etc.)
* Planned omission of long-acting paralytics
* Need for awake airway management
* Need for emergent airway protection
* Presence of oropharyngeal anatomic abnormalities
* Distance from the maxillary incisors to the angle of the mandible \<11cm
* \<18 years of age
* Known pregnant state
* Current incarceration
* Refusal to be involved in the study
A Phase 2 Study to Learn About a Monovalent Pneumococcal Conjugate Candidate in Healthy Toddlers

The purpose of the study is to learn about the effects of a monovalent (single component) pneumococcal conjugate candidate (mPnC candidate) when given to toddlers between 11 and 15 months of age.

All participants in this study will receive 2 doses of either mPnC candidate or mPnC control at the clinic approximately 8 weeks apart. All participants will also receive their third (toddler) dose of PCV10 at Visit 1.


Eligibility Criteria:
Key Inclusion Criteria:

* Toddlers ≥11 to ≤15 months of age at the time of consent.
* Have received exactly 2 infant doses of PCV10 according to a local immunization schedule.
* Healthy toddlers determined by clinical assessment, including medical history and clinical judgment, to be eligible for the study.

Key Exclusion Criteria:

* History of severe adverse reaction associated with a vaccine and/or severe allergic reaction (eg, anaphylaxis) to any component of study intervention, 13vPnC, 20vPnC, or any diphtheria toxoid-containing vaccine.
* significant neurological disorder or history of seizure (excluding febrile seizure) or significant stable or evolving disorders such as cerebral palsy, encephalopathy, hydrocephalus, or other significant disorders.
* Major known congenital malformation or serious chronic disorder.
* History of microbiologically proven invasive disease caused by S pneumoniae.
* Previous vaccination with any licensed pneumococcal vaccine (other than the PCV10 primary infant series) or investigational pneumococcal vaccine, or planned receipt of nonstudy pneumococcal vaccine during study participation.
Effect of Vaginal Douching With Betadine Before CS for Prevention of Post Operative Infections

The present study was a prospective randomized controlled trial in which subjects received a vaginal preparation with povidone-iodine solution immediately prior to caesarean delivery or received no vaginal preparation

The present study was a prospective randomized controlled trial in which subjects received a vaginal preparation with povidone-iodine solution immediately prior to caesarean delivery or received no vaginal preparation

Eligibility Criteria:
Inclusion Criteria:

* Any patient undergoing CS

Exclusion Criteria:

* • Betadine allegy.

  * Rupture membranes.
  * Accidental Hemorrhage.
  * H/O suggestive chorioamnionitis ; uterine tenderness, offensive vaginal discharge, fever medical disorders as diabetes, hypertension , cardiac or renal diseqases
Impact of Ban on Smoking in Pubs, Restaurants and Nightclubs on Endothelial Function in Workers

Endothelium is considered a real member, so it is contributing to determine the vascular homeostasis. The presence of endothelial dysfunction, evaluated in peripheral arteries by non-invasive study of the variation of gauge of the brachial artery as a result of post-ischemic hyperemia (FMD), is predictive of occurrence of major cardiovascular events. Several recent studies have shown that passive smoking is correlated with endothelial dysfunction and, therefore, non-smokers exposed subjects to passive smoking, have an increased risk of occurrence cardiovascular pathologies. From January 2008, a ministerial decree will ban smoking in bars, restaurants and nightclubs. The impact of exposure end to smoking in non-smoking subjects, as part of a prospective study and controlled, has never been evaluated.


Eligibility Criteria:
Inclusion Criteria:

* Subject exposed at least one hour per day to passive smoking at work during at 1 year minimum for intervention arm and non exposed to passive smoking for control group.
* Subject having signed informed consent
* Subject with social security insurance or equivalent

Exclusion Criteria:

* Exposition to passive smoking at home
* Active smokers (at least 1 cigarette per day or having drawn up active smoking for less than a month)
* Medical history of homozygote familial hypercholesterolemia
* Usage of lipid lowering treatment in the month before the inclusion
* Hepatic active pathology or hepatocellular insufficiency
* Severe kidney disease (with creatine clearance less than 30 ml per minute)
* Evolutive cancer
* Usage of concomitant treatment as : insulin, nitro-derivatives and statins
* Medical history of alcoholism or drug use last year
* Medical history of permanent systolic hypotension (systolic blood pressure less than 90 mmHg) or non controled hypertension (systolic blood pressure higher than 200 mmHg and diastolic blood pressure 110 mmHg)
* Active cardiovascular disease
* Psychological or medical conditions incompatible with the study according to investigator opinion
* Participation to another study with experimental product or subject having received an study treatment within 4 weeks before inclusion
* Impossibility to follow the study procedure
* Pregnancy and breastfeeding
* Subject protected by french law
Bioequivalence Study of Torrent Pharmaceuticals Ltd's Clopidogrel Tablets Under Fasting Conditions

Objective:

Primary objective of the present study was to compare the single dose bioavailability of Torrent's Clopidogrel Tablets USP 1 × 75 mg and Plavix® (Clopidogrel Bisulfate) Tablets 1 × 75 mg of Bristol-Myers Squibb/Sanofi Pharmaceuticals, USA. Dosing periods were separated by a washout period of 7 days.

Study Design:

Open-Label, Randomised, two Period, two treatment, Crossover, Single-Dose Bioequivalence Study


Eligibility Criteria:
Inclusion Criteria:

The volunteers were included in the study based on the following criteria:

* Sex: male.
* Age: 18 - 45 years.
* Volunteer with BMI of 18-27 (inclusive both) kg/m2 with minimum of 50 kg weight.
* Healthy and willing to participate in the study.
* Volunteer willing to adhere to the protocol requirements and to provide written informed consent.
* Non-smokers or smoker who smokes less than 10 cigarettes per day

Exclusion Criteria:

The volunteers were excluded from the study based on the following criteria:

* Clinically relevant abnormalities in the results of the laboratory screening evaluation.
* Clinically significant abnormal ECG or Chest X-ray.
* Systolic blood pressure less than 100 mm Hg or more than 140 mm Hg and diastolic blood pressure less than 60 mm Hg or more than 90 mm Hg.
* Pulse rate less than 50/minute or more than 100/minute.
* Oral temperature less than 95°P or more than 98.6°P.
* Respiratory rate less than 12/minute or more than 20/minute
* History of allergy to the test drug or any drug chemically similar to the drug under investigation.
* History of alcohol or drug abuse
* Positive breath alcohol test
* Recent history of kidney or liver dysfunction.
* History of consumption of prescribed medication since last 14 days or OTC medication since last 07 days before beginning of the study.
* Volunteers suffering from any chronic illness such as arthritis, asthma etc.
* History of heart failure.
* HIV, HCV, HBsAg positive volunteers.
* Opiate, tetra hydrocannabinol, amphetamine, barbiturates, benzodiazepines, - - - Cocaine positive volunteers based on urine test.
* Volunteers suffering from any psychiatric (acute or chronic) illness requiring medications.
* Administration of any study drug in the period 0 to 3 months before entry to the study.
* History of significant blood loss due to any reason, including blood donation in the past 3 months.
* History of pre-existing bleeding disorder.
* Existence of any surgical or medical condition, which, in the judgment of the chief investigator and/or clinical investigator/physician, might interfere with the absorption, distribution, metabolism or excretion of the drug or likely to compromise the safety of volunteers.
* Inability to communicate or co-operate due to language problem, poor mental development or impaired cerebral function.
Reappraisal of Atrial Fibrillation: Interaction Between HyperCoagulability, Electrical Remodeling, and Vascular Destabilisation in the Progression of Atrial Fibrillation

The purpose of this study is to study clinical factors and (blood) biomarkers related to progression of Atrial Fibrillation (AF) in patients diagnosed with self-terminating AF with special reference to hypercoagulability. All patients will be continuously monitored for their atrial rhythm to assess AF progression, either through an implantable loop recorder (Reveal LinQ) or via the atrial lead of a cardiac implantable electronic device (CIED), both in combination with the CareLink home monitoring system. Remote monitoring and interrogation will be installed and used on a daily basis.


Eligibility Criteria:
Inclusion Criteria:

* New onset or history of paroxysmal, self-terminating AF documented as:

  * AF on ECG or Holter-recording or loop recorder
  * Subclinical AF detected in implantable cardiac devices (atrial read \> 190 beats per minute, lasting \> 6 minutes).
* Prior history of self-terminating AF is allowed;
* Able and willing to sign informed consent for the registry;
* Able and willing to undergo implantation of an implantable loop recorder (in patients without a CIED);
* In patients already on oral anticoagulation drugs, the following inclusion criteria need to be met (to allow for safe temporary interruption of anti-thrombotic treatment for coagulation phenotyping):

  * CHA2DS2-VASc score ≤5 (history of Congestive heart failure, Hypertension, Age ≥ 75 years (doubled), Diabetes mellitus,Stroke/transient ischemic attack (doubled), Vascular disease, Age 65-75 years, female Sex);
  * No other indication for oral anticoagulation (e.g. mechanical valve prosthesis);
  * Patient is willing to temporarily stop oral anticoagulation drugs (OAC).

Exclusion Criteria:

* Non-self-terminating, persistent AF;
* Deemed unsuitable or not willing to undergo implantation of loop recorder (in patients without a CIED);
* Refusing to temporarily stop OAC for coagulation phenotyping (in patients already on OAC before inclusion in this study);
* On waiting list for pulmonary vein isolation or expected to be placed on waiting list within one year;
* Expected to start with amiodarone;
* Pregnancy;
* Life expectancy of less than 2.5 years.
PCOS (Polycystic Ovarian Syndrome) Patients

The Prospective Cohort Study for PCOS Patients was set up to investigate the short- and long-term health consequences in Reproductive Medical Center, First Affiliated Hospital of Zhengzhou University, China.

Polycystic ovary syndrome (PCOS) affects 8-13% of women. It is a multifaceted condition characterized by chronic anovulation and excess ovarian activity.

Since last decade, Clinical Reproductive Medicine Management System/Electronic Medical Record Cohort Database (CCRM/EMRCD) has been used in Reproductive Medical Center, First Affiliated Hospital of Zhengzhou University, and Henan Province Key Laboratory for Reproduction and Genetics. Information of patients (POI, PCOS, Endometriosis, azoospermia, ect) were recorded comprehensively. The current project plans to recruit PCOS participants in our center. Biological samples, questionnaires and short/long term health data will be collected. The study is aimed to provide evidence for PCOS prognosis.

Eligibility Criteria:
Inclusion Criteria:

* PCOS patients diagnosed with The Rotterdam diagnostic criteria.

Exclusion Criteria:

-