cyrilzakka/clinical-trials huggingface dataset:
Trial With Allergic Rhinitis Patients Taking GSK256066 Versus Placebo In A Pollen Challenge Chamber

This study is in patients with seasonal allergic rhinitis (SAR) and will compare the effect versus placebo of repeat doses of intranasal GSK256066 using the Vienna Challenge Chamber. GSK256066 is a potent and highly selective phosphodiesterase-4 (PDE4) inhibitor, currently in development by GSK for the treatment of allergic rhinitis, asthma and COPD.

Subjects will be selected on the basis that they display a defined moderate response to the pre-determined dose used.

This study aims to explore the actions of repeat doses of intranasal GSK256066 in patients with Seasonal Allergic Rhinitis in the Vienna Challenge Chamber compared to placebo.

12-lead ECG, vital signs and adverse event enquiries will be made throughout the study. Nasal examination, symptom scores (TNSS), nasal lavage, nasal scrape and allergen challenge assessments will also be performed at various time points throughout the study.


Eligibility Criteria:
Inclusion Criteria:

* The subject is healthy.
* They are aged 18 to 50 years inclusive.
* Body mass index less than 29.0 kg/m² with weight range of 55.0kg (females 50kg) to 95.0kg inclusive.
* They have a history of seasonal allergic rhinitis
* They exhibit a moderate response to 1500 grass pollen grains/m3 after 2h in the Vienna Challenge Chamber,
* They have a positive skin prick test for grass pollen at or within the 12 months preceding the screening visit.
* They have a positive RAST for grass pollen at or within the 12 months preceding the screening visit.
* They are current non-smokers who have not used any tobacco products in the 6 months preceding the screening visit
* They must have a baseline FEV1\>80% predicted and a baseline FEV1 (maximum recorded value)/ FVC (associated value)\>70% predicted.

Exclusion Criteria:

* Pregnant or nursing females.
* Women of childbearing potential who are unwilling or unable to use an appropriate method of contraception.
* any structural nasal abnormalities or nasal polyposis, a history of frequent nosebleeds, recent nasal surgery or recent (within 2 weeks) or ongoing upper respiratory tract infection.
* The subject is likely to be unable to abstain from salbutamol use for 8 hours before a challenge
* The subject has a history of drug or other allergy
* The subject is concurrently participating in another clinical study in the past 3 months
* A supine blood pressure that is persistently higher than 140/90 millimetres of mercury (mmHg) at screening
* A supine mean heart rate outside the range 40-90 beats per minute (bpm) at screening.
* The subject has donated a unit of blood within the previous 3 months.
The Clinical Efficiency of Tb-ERA in Chinese RIF Patients

In order to further explore the clinical utility of endometrial receptivity array in patients with repeated implantation failure, the patients divide into the experimental group or the control group. In the experimental group, those patients undergo endometrial receptivity array. In the control group, those patients do not receive any treatment before next cycle of transfer. In the experimental group, according to the results of endometrial receptivity array, the transplantation time will be adjusted and retransplantation will be carried out. Statistical analysis of the two groups of primary endpoint and secondary endpoint are done.

In the field of assisted reproduction techonology, there are still 10% of patients with repeated implantation failure. In order to further explore the clinical utility of endometrial receptivity array in patients with repeated implantation failure, the patients divide into the experimental group or the control group. In the experimental group, those patients undergo endometrial receptivity array. In the control group, those patients do not receive any treatment before next cycle of transfer. In the experimental group, according to the results of endometrial receptivity array, the transplantation time will be adjusted and retransplantation will be carried out. In the control group, no intervention will be performed. Statistical analysis of the two groups of primary endpoint (clinical pregnancy rate) and secondary endpoint (endometrial implantation window evaluation results, embryo implantation rate, biochemical pregnancy rate, early abortion rate, ectopic pregnancy rate) are done. Through the comparative analysis of clinical outcomes to verify the clinical efficacy of endometrial receptivity analysis in patients with repeated implant failure, this method will provide a new treatment for repeated implant failure population.

Eligibility Criteria:
Inclusion Criteria:

1. People with unexplained repeated implantation failure (3 or more times of transplantation, at least 4 or more high-quality embryos failed to conceive).
2. Age: 20-40 years old.
3. BMI: 19 - 24.
4. The thickness of endometrium is more than or equal to 7 mm.

Exclusion Criteria:

1. Known causes of embryo implantation failure, such as infection, reproductive tract malformation, uterine cavity factors, immune factors, hydrosalpinx, etc.
2. Decreased ovarian function (meet the following at least two criteria: ① 10u / L \< basal follicle stimulating hormone (FSH) \< 25U / L, and / or estradiol (E2) \> 292.8pmol/l, and / or FSH / LH \> 3; ② the number of antral follicles \< 5-7 on the second to third day of menstruation; and (or) antimullerian hormone (AMH) \< 0.5-1.1ng/ml.
3. People with genetic history.
4. Those who have done abortion and the histogenetic analysis are positive.
Ocular Surface Dry Eye Microbiome

The investigators seek to characterize the identity of all microorganisms residing on the eye's surface (conjunctiva) in healthy eyes and those with dry eye syndrome, using a combination of analyses. Dry eye disease is thought to have an inflammatory basis and in the vast majority of cases the cause of the chronic inflammatory condition is unknown.


Eligibility Criteria:
Inclusion Criteria:

* dry eye syndrome with OSDI score greater than 60
* control group with OSDI score less than 30

Exclusion Criteria:

* recent history of contact lens wear
* use of topical antibiotics or prescription eye medication in past 6 months
* penetrating ocular surgery in the last 12 months
* age less than 18 years
A Open-label, Randomized, Crossover Study to Assess PK of Pregabalin

The purpose of this trial to compare the pharmacokinetic characteristics of YHD1119(Pregabalin 300mg) and Lyrica capsule(Pregabalin 150mg). YHD1119 is controlled release formulation which is made by Yuhan Corporation. Primary endpoints are Cmax,ss and AUCtau and secondary endpoints are AUClast,ss, AUCinf,ss, Tmax,ss and t1/2.


Eligibility Criteria:
Inclusion Criteria:

* 19\~50 years old, healthy male volunteers
* \>55Kg(Body weight) and 18.5\<BMI\<28

Exclusion Criteria:

* AST or ALT \> 3 \* Upper normal range (Lab)
* Total bilirubin \> 2.0 mg/dl
* Systolic BP \>140 OR \<90, Diastolic BP \>100 OR \<60
A Study of Nivolumab in Advanced Non-Small Cell Lung Cancer (NSCLC)

The purpose of this study is to determine whether nivolumab monotherapy or in combination with Standard of care (SOC) therapies will provide clinical benefit (i.e., PFS, OS, and DOR) without unacceptable toxicity in advanced Non-Small Cell Lung Cancer patients.

Epidermal Growth Factor Receptor (EGFR), Anaplastic Lymphoma Kinase (ALK)

\*\*Please note that the study is no longer enrolling patients for Groups A, B, C, and E.

Eligibility Criteria:
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

* Histologically confirmed locally advanced or stage IV NSCLC
* Eastern Cooperative Oncology Group (ECOG) Performance status (PS) 0-2
* Tumor tissue sections must be available for biomarker evaluation

Exclusion Criteria:

* Untreated or active/progressing Central Nervous system (CNS) metastases
* Active, known or suspected autoimmune disease
* Known history of testing positive for HIV or AIDS
* Active or chronic infection of hepatitis B virus or hepatitis C
Changes of Ocular Structures After Hemodialysis in Patients With Chronic Kidney Diseases

To evaluate the effect of hemodialysis on various ophthalmologic parameters in patients with end-stage kidney disease (ESRD).

Subjects: patients with ESRD undergoing hemodialysis at the Dialysis Center of Hanyang Guri Hospital

Ocular parameters: visual acuity, intraocular pressure, axial length, OCT Other systemic parameters: body weight, ultrafiltration volume, and systolic/diastolic blood pressure

All measurements were performed near the dialysis center. Measurements were performed on Monday (for patients who underwent dialysis sessions on Monday, Wednesday, and Friday) or Tuesday (for patients who underwent dialysis sessions on Tuesday, Thursday, and Saturday.

All parameters were measured before and after the hemodialysis.

Eligibility Criteria:
Inclusion Criteria:

* 1) patients who are regularly dialyzed in our dialysis room to participate in the study
* 2) patients who agree with our study protocol
* 3) patients who have unstable general condition

Exclusion Criteria:

* 1) previous intraocular surgery, (2) baseline IOP greater than 22 mmHg, (3) presence of glaucomatous optic disc changes including excavation, thinning, or notching of the neuroretinal rim, (4) axial length greater than 26 mm, and (5) combined macular and retinal diseases such as central serous chorioretinopathy and age-related macular degeneration, except diabetic retinopathy.
Sonography and Haemophilia

The aim of this study is to evaluate the possibility of establishing a patient-based ultrasound monitoring of the knee (representing a target joint accessible with any hand) with a handheld device:

The following questions will be answered:

1. What is necessary for the organisational implementation of a patient-based ultrasound monitoring in patients with haemophilia?
2. Is it possible to train patients with haemophilia to perform sonography of their target joints?
3. Does a patient-based ultrasound monitoring with a handheld device work in a home setting?
4. What is the quality of the patient's self-acquired ultrasound images?
5. Will the test persons be able to distinguish normal findings from (any) pathologic findings?


Eligibility Criteria:
Inclusion Criteria:

* Adult patients (≥ 18 years of age) suffering from severe haemophilia A or B
* No professional medical background
* Submitted written consent to participate in the study and to use their study related pseudonymized data

Exclusion Criteria:

* Patients suffering from other bleeding diseases
* Participants \< 18 years of age
* Participants without written consent
* Professional medical background
Effect and Safety of Electroacupuncture for Symptoms of Menopausal Transition

The primary object is to evaluate the efficacy and safety of electroacupuncture for symptoms of women during menopausal transition .

Menopause transition is called perimenopause in the past time. 40-80% women aged 40 to 65 have symptoms during this period. Hormone therapy is the recommended therapy for menopause and there is not enough evidence in favor of alternative medicine's effect.

Our pilot trial showed that electroacupuncture had better effect for menopause transition symptoms than sham electroacupuncture. We are going to conduct a phase Ⅱ clinical trial to further evaluate the safety and effect of electroacupuncture for menopause transition symptoms.

Eligibility Criteria:
Inclusion Criteria:

1. Cycle irregularity (periods occur 7 days or over earlier or later ) in the past 12 months (early menopausal transition); subjects with the last menstruation at least 2 but no longer than 12 months in the past 12 months (late menopausal transition).
2. Menopausal transition symptoms such as hot flushes, sweating, sleep disturbance, migraine, anxiety, vaginal dryness and sexual problems.
3. 40 to 55 years old.
4. Volunteer to join in the trial and sign the informed consent. Patients conformed with the 4 items at the same time will be included. -

Exclusion Criteria:

1. Regular cycles during the past 3 months before enrollment.
2. use of estrogen, SSRIs, soybean isoflavone, progestin, vitamin E or black sesame in the past 4 weeks.
3. Patients with ovarian cyst, uterine myoma (diameter≥4cm) or after hysterectomy/ ovariectomy.
4. Patients with radiochemotherapy history or undergoing radiochemotherapy.
5. Cryptogenic vaginal bleeding
6. Coagulation disorder or use of anticoagulants like warfarin and heparin sodium.
7. Existing skin diseases like eczema or psoriasis.
8. Severe hepatic/renal insufficiency.
9. Insufficiently controlled hypertension, diabetes or thyroid diseases.
10. Existing diabetic neuropathy, malignant tumor and psychiatric disorders.
11. Wish to become pregnant or is pregnant or breast-feeding.
12. Regular use of sedative or anxiolytic.
13. Smoking or alcohol intake.
14. Subjects with mandatory indication for HT (e.g. postsurgical menopause or active osteoporosis).
15. With cardiac pacemaker or artificial joint.
G-CSF and PRP in Patients With Recurrent Implantation Failure

The aim of this randomized controlled trial is to determine whether granulocyte colony-stimulating factor and platelet-rich plasma can be used to enhance the IVF-ET outcomes in patients with recurrent implantation failure


Eligibility Criteria:
Inclusion Criteria:

• Patients with history of three or more unsuccessful IVF-ET cycles with at least 2 good quality embryos transferred

Exclusion Criteria:

* Endometriosis
* Uterine anomalies
* Asherman syndrome
A Feasibility Study of the Cordis Neurovascular Self Expanding Stent System in Intracranial Arteries

Feasibility study to assess safety of treating patients with self expanding stent in intracranial arteries.

Feasibility study to assess safety of treating patients with self expanding stent in intracranial arteries. Patients will be followed for 6 months with assessments related to technical feasibility and adverse events.

Eligibility Criteria:
Contact site for specific information

Inclusion Criteria:

* Subject meet specific criteria for treatment
* Subject must be willing to return to site for 30 day and 6 month follow up evaluations

Exclusion Criteria:

* Stenting, angioplasty or endarterectomy of an extracranial (carotid or vertebral artery) or intracranial artery within 30 days prior to expected enrollment date
* Previously implanted carotid stent associated with the symptomatic distribution within the past 12 weeks
Robotics as a Useful Tool to Improve the Hydration of the Elderly

The aim of this clinical trial is to evaluate the effectiveness of a hydration educational program executed through a robot in comparison with the usual hydration program in terms of fluid intake and general health status of the residents. The main question to be answered is whether the use of robotics through a humanoid robot increases the hydration of institutionalized older people.

Participants:

* The intervention group will receive a hydration plan executed by the robot and the control group will receive the center\&#39;s usual hydration plan.
* Healthcare personnel will receive reminders from the robot to record fluid intake through it. In the control group, health personnel will perform the fluid intake record in paper format and at the end of the shift, as usual.


Eligibility Criteria:
Inclusion Criteria:

* Age equal to or greater than 65 years.

No exclusion criteria have been established.
Cryoanalgesia for Irreversible Pulpitis

The aim of the present study was to evaluate the effectiveness of pulpal anesthesia in pain control during endodontic treatment by lowering the temperature of the injected plain 3% cold Mepivacaine (5ºC) compared to 3% Mepivacaine at room temperature in teeth with irreversible pulpitis.

Mepivacaine has some advantages over other anesthetics. The investigators wanted to compare whether changing temperature could improve its effectiveness in cases of irreversible pulpitis.

Eligibility Criteria:
Inclusion Criteria:

All Patients within the age group of 18-100 years old,

* Patients diagnosed of irreversible pulpitis.

Exclusion Criteria:

* Moderate to pulp necrosis,
* Previous initiated treatment.
* Pregnancy or lactation.
* Allergy or problems to any substances used in the study,
* Acute apical abscess.
* Chronic apical abscess.
* Unrestorable teeth.
* Unsuccessful anesthesia technique (no lip numbness for lower molars or positive response to cold test).
Breastfeeding Improvement Following Tongue-tie and Lip-tie Release

This study is an observational study to determine outcomes of surgical release of tongue-tie and lip-tie in babies who are experiencing difficulty with breastfeeding.

Breastfeeding rates in the United States initiate at around 80%, but many mothers are unable to effectively breastfeeding because of problems with latch and suction generation. Previous studies have demonstrated how nipple pain is directly linked to ankyloglossia, but most of these studies are done with poor methodology.

Clinically, tongue-tie and lip-tie have correlate with numerous other symptoms besides nipple pain. These babies tend to be inefficient nursers, which can affect weight gain. Abnormal intake of air because of the poor latch/seal can lead to reflux symptoms. Finally, there is a significant psychological toll on mothers who want to breastfeed but cannot do so.

This study aims to prospectively analyze these outcomes by using validated tools.

Eligibility Criteria:
Inclusion Criteria:

* Healthy babies who are breastfeeding 0-12 weeks of age

Exclusion Criteria:

* Serious comorbid conditions (heart, lung, brain)
* Prior maternal breast surgery
* Insufficient glandular tissue
* Previous tongue/lip surgery
* Twins/Triplets
Lymphomyosot for Ankle Edema Following Fracture

Ankle fractures are invariably complicated by severe soft-tissue swelling which can significantly prevent surgical repair (open reduction and internal fixation - ORIF) of the fractured bone for up to two weeks. The delay in surgical treatment can increase the risk for local skin and bone complications, as well as for deep venous thrombosis. Lymphomyosot® is a non-prescription, homeopathic complex drug which has been used for more than 70 years throughout Europe and the U.S., primarily for tissue edema and swelling.

This is a randomized, placebo-controlled, double blind pilot study evaluating the effectiveness of homeopathic combination drug Lymphomyosot® compared to placebo treatment. The study will take place at the Shaare Zedek Medical Center in Jerusalem, Israel. Adult patients (age 18 years and older) admitted to the orthopedic department with acute ankle fractures which require ORIF repair will be assessed for inclusion in this study.

The primary outcome measure to be evaluated is the fracture-ORIF waiting period. Other measures to be evaluated are: peri-malleolar circumference; pain (as measured by NRS and analgesic use); duration of hospital stay; and complications such as poor wound healing, blisters, and the development of deep vein thrombosis.


Eligibility Criteria:
Inclusion Criteria:

* 18 years of age and older
* patients with a fracture of the ankle requiring ORIF
* signed informed consent form.

Exclusion Criteria:

* refusal or inability to give informed consent
* bilateral fractures of the foot or ankle, open fractures, poly-trauma, contralateral limb amputation
* currently on anticoagulation therapy
* clinical indication for immediate surgery.
* ability to undergo surgery on the day of the fracture , or where soft-tissue edema was not the cause which prevented immediate surgery
* any additional injury that prevents partial weight-bearing.
* a concomitant fracture of another long bone in the ipsilateral leg
* if the patient suffers from a systemic disease such as diabetes, malignant tumor, severe peripheral vasculopathy, and/or metabolic disease
* concurrent participation in another study
* inability to comply with the study protocol
Cognitive Effects and Potential Mechanisms of TBS in Subjects With MCI

This study aims to examine the effects and potential mechanisms of theta-burst stimulation (TBS) on cognitive function in individuals with mild cognitive impairment (MCI).

The investigators apply the NIA-AA criteria to subtype different endophenotypes of biomarker-defined MCI individuals. This is a prospective, open-label clinical trial, and combined functional neuroimaging study of 18F-FDG-PET to further explore the potential mechanisms. A total of 80 MCI patients will be consecutively recruited and be subjected to iTBS for 5 daily interventions per week for two consecutive weeks. Cognitive evaluation will be performed before and immediately after TBS intervention, and 8 weeks after TBS. Data on functional neuroimaging will be also collected before and after TBS protocol.

Eligibility Criteria:
Inclusion Criteria:

1. Subjects aged 50-90 year
2. Subjects meet Petersen's criteria for mild cognitive impairment (Petersen, Smith et al. 1999)
3. The CDR of MCI patients can be 0-0.5
4. Amyloid PET should ever be performed

Exclusion Criteria:

1. Any subject has a definite diagnosis of epilepsy or history of seizure attack.
2. Current or past history of clinically significant neurological insults affecting brain structure or function like completed stroke, head injury or brain tumor.
3. Any subject has clinically significant or unstable medical diseases including metabolic, renal,liver, lung or cardiovascular disorders including metabolic, renal, liver, lung or cardiovascular disorders.
4. Any subject has current alcohol or other substances abuse and/ or dependence within the recent one year, or prolonged history of major psychiatric disorder like schizophrenia,bipolar disorder, and previously prolonged substances abuse.
5. Any females who is pregnant or lactating.
6. General MRI, TMS and/or PET exclusion criteria including subjects who had received brain aneurysm surgery, or implanted pacemaker, mechanical valves, cochlear implant or other metal devices/ objects that are not MR compatible in the body.

Withdrawal criteria

1. Complications onset after intervention that affect efficacy and safety judgments.
2. New onset or progression of disease that may affect outcomes.
3. Use of other therapies or drugs during the intervention period to change cognitive functions.
4. Any subjects who are recognized as high risk of adverse effects by principle investigator.