cyrilzakka/clinical-trials huggingface dataset:
Efficacy and Safety of HCP1102 Capsule

Efficacy and safety of HCP1102 capsule : A randomized, double-blind, active-controlled, multicenter phase 3 clinical trial.


Eligibility Criteria:
Inclusion:

* Age≥15
* Mild or moderate asthma patients with allergic rhinitis
* Patient who meet all criteria of rhinitis
* Patients understood the contents and purpose of this trial and signed informed consent form
* Patients who are capable and willing to write subject diary
* Patients who agree with maintain same environment during clinical trials

Exclusion:

* Nonallergic rhinitis
* Severe asthma
* Other pulmonary disease (pulmonary tuberculosis, COPD) except Asthma
* Medical history of hypertrophic cardiomyopathy, cancer, renal disease, Liver disease, cardiovascular disease, respiratory disease, endocrine disorder, CNS disorder that effect safety
* Medical history of gastrointestinal surgery or gastrointestinal disorders that effect drug absorption
* Alcohol abuse or Drug abuse
* Genetic factor of galactose intolerance or Lapp lactase deficiency or glucose-galactose malabsorption
* pregnant or breast-feeding women or men/women of childbearing age that they don't use contraceptives
* Patient who administered other investigational products within 30 days
* Current smoker Judged to be inappropriate for the study by the investigator after reviewing other reasons
Comparison of Metvix Photodynamic Therapy (PDT) With Its Vehicle in the Treatment of Photoaged Skin

Skin photoaging or skin photodamage were terms used to describe the change in the structure, function and appearance of skin caused by prolonged and repeated exposure to sunlight or other ultraviolet light sources.

The visible effects of skin photodamage were fine lines, skin sagging, skin roughness, liver spots and also the appearance of red patches made up of thin red vessels (called telangiectasia).

More and more people were presenting to doctors with concerns about skin photodamage and the demand for corrective procedures was increasing.

Metvix photodynamic therapy (Metvix PDT) is a procedure currently marketed in several countries in Europe (including the United Kingdom \[UK\] and Spain) and in Australia, for the treatment of benign forms of skin cancer (example, actinic keratosis).

The aim of the study was to assess whether Metvix PDT would be effective in correcting the effects related to photodamage and whether it would be well tolerated.

Different application times of the study treatment were being investigated.

Eligibility Criteria:
Inclusion Criteria:

* Male or female participants older than 30 years of age.
* Participants with a photodamage grade of at least 4 on the Griffiths photonumeric scale (symmetrical photodamage on the two target areas)
* Participants with mottled hyper-pigmentation on the face
* Participants willing and capable of cooperating to the extent and degree required by the protocol
* Participants must read the Patient Information Sheet and read and sign the Informed Consent form prior to any study related procedures.

Exclusion Criteria:

* Participants who were at risk in terms of precautions, warnings, and contra-indication in the package insert for Metvix
* Participants with suspected porphyria
* Participants with specific wash-out period for interfering treatments
* Participants requiring concurrent treatment that would interfere with study objectives and/or evaluations
Bread in Overweight/Obesity Treatment

The purpose of this study is to determine the utility of an hypocaloric diet with or without bread in patients with overweight and obesity


Eligibility Criteria:
Inclusion Criteria:

* age \> 18 years
* sex female
* signed informed consent
* patient with overweight and obesity (IMC: \> 25 \< 39.9)

Exclusion Criteria:

* Family and social environment that prevents compliance with treatment diet.
* Having to perform any kind of diet special sickness associated: Celiac disease, chronic renal failure, etc.
* patients with Diabetes Mellitus.
* patients with Eating disorders.
* patients with Dementia, Mental illness or impaired function cognitive.
* consuming drugs or substances for losing weight (except in those cases in which suspension thereof 15 days of beginning the study).
* Present disease which may interfere with weight loss: serious psychiatric disease, hypothyroidism not controlled.
* Be pregnant or period of lactation.
* Inability to comply with the physical activity plan agreed.
* Want to quit smoking during the time that lasts for the study.
Intra-individual Stability in Electroencephalography (EEG) Parameters

The main objective is to evaluate the stability of EEG features on an individual level.


Eligibility Criteria:
Inclusion Criteria:

* Age must be in the range 50 - 90 years

Exclusion Criteria:

* Outside required age range
Pilot Study of Intra-Arterial Cisplatin With IV Thiosulfate in Patients With Lung Cancer or Lung Metastases

This phase I study proposes the use of systemic thiosulfate rescue to allow supradose intra-arterial cisplatin delivery to lung tumors. Eligible patients would be those with at least one lung lesion large enough of characterize angiographically. All patients will first undergo a CT arteriogram of the target tumor. Patients will then receive 2 treatments on 2 consecutive weeks. The primary endpoint will be toxicity, with secondary endpoint of response as measured on week 4. This pilot study will also determine how technically feasible it is to locate the blood supply to these tumors and deliver cisplatin.

If the first 6 patients do well, 6 additional patients will be accrued for a total of 12.


Eligibility Criteria:
Inclusion Criteria:

* Primary lung cancer (any type) or dominant lung metastases from other primary cancers.
* Patients must have either measurable or evaluable disease.
* Karnofsky performance status ≥ 70%.
* Greater than 18 years of age.
* Life expectancy \> 3 months.
* 3 week elapse from previous cytotoxic therapy (except for erlotinib or hormonal therapy, which can be ongoing) with side effects improved to grade 2 or less, and no prior radiotherapy to the lung.
* Adequate organ function.
* Treated brain metastases, if present, with toxicities improved to grade 2 or less.
* Willingness and ability to sign a written informed consent.

Exclusion Criteria:

* Prior radiation to the largest lesion in the lung.
* Current pregnancy or breast-feeding.
* Unwillingness or inability to practice contraception.
* Renal insufficiency.
* Comorbidities of grade 3 or greater.
* Concurrent medical or psychiatric conditions as defined by the treating physician which would preclude safe performance of study procedures or compromise the ability of the patient to consent to study.
Child Follow-up in Women Treated With Conventional IVF or ICSI

To compare the physical, mental and motor development of babies born from pregnancy using ICSI technique and and conventional IVF in non-male factor infertile couples. Based on our previous RCT (NCT03428919), the non-male factor couples were randomly assigned to IVF or ICSI, which leads to the similarity in characteristics of these two groups. Hence, the result of analyzing these offsprings would be preciously valuable.

Over the past two decades, intracytoplasmic sperm injection (ICSI) indications have been extended and routinely applied to all cases of assisted reproductive techniques: unexplained infertility, poor-quality oocytes, low oocyte yeild, advanced marternal age, prior failed fertilization with conventional insemination, after in-vitro maturation of oocytes and for cases of cryopreserved oocytes (Practice Committees of the American Society for Reproductive Medicine, 2020). In 2004, fertilization using ICSI accounted for nearly 60% of all aspirations globally. In the Middle East, the number of ICSI cycles increased rapidly from 2000 (47.6%) to 2007 (65.2%), and reached 97.8% in the Middle East in 2007 (Ishihara et al, 2015). Another survey recorded in Europe in 2011, out of a total of 437,510 cycles of fresh embryo transfer, 68% of cycles were performed using ICSI techniques. In male infertility cases, the rate of implementation of ICSI increased from 76.3% to 93.3%. In particular, in cases of non-male-factor infertility, the incidence of ICSI also increased from 15.4% to 66.9%. From 2008-2012, of 494 907 treatment cycles, 74.6% used ICSI. In which, ICSI accounts for 92.9% of the cycle of male infertility and 64.5% of the cycle of non-male-factor infertility (Boulet, 2015).

However, ICSI is an invasive technique that bypasses the natural barriers of fertilization. This has led to concern about an increase in the incidence of anomalies in ICSI-born babies as this technique is increasingly being used in all cases of contraception. In contrast, there are studies that have also compared IVF with ICSI and show that in the ICSI cycle, the incidence of multiple pregnancies and low birth weight infants is lower than that of IVF, although there is no difference in infant survival between the two groups (Boulet et al, 2015).

In addition to the short-term outcomes, the investigators also have to consider the long-term maternal and neonatal outcomes. There is still not much evidence comparing the effects of the above methods, if any, on the psychomotor development in children.

Therefore, the investigators decide to conduct a study to compare the physical, mental and motor development of babies born from pregnancy using ICSI technique and and conventional IVF in non-male factor infertile couples.

Eligibility Criteria:
Inclusion Criteria:

* Live babies born from ICSI Versus Conventional IVF in Non-male Factor Couples (NCT03428919)
* Parents agree to participate in the study.

Exclusion Criteria:

* Babies died after the perinatal period.
Daily Bitemporal Low-frequency Transcranial Random Noise Stimulation in Tinnitus (tRNS2-tin)

Stimulation of the left and right auditory cortex with daily low-frequency transcranial random noise stimulation (tRNS) is used to modulate the neural pathways involved in chronic tinnitus.

Tinnitus is the phantom auditory perception of sound in the absence of an external or internal acoustic stimulus. It is a frequent problem which can interfere significantly with the ability to lead a normal life. Tinnitus has been shown to be generated in the brain, as a result of functional reorganization of auditory neural pathways and the central auditory system. These changes are represented by hyper-activity and hyper-synchronicity in the auditory pathway. Treatment remains difficult. Non-invasive brain stimulation methods has shown to be effective in the treatment of chronic tinnitus with moderate effect size. First data suggest the use of transcranial random noise stimulation (tRNS) over both auditory cortices as new and highly effective treatment. Low-frequency (lf; \<100Hz) tRNS might be highly effective in tackling hyper-synchronised cell assemblies. Daily lf-tRNS (2 weeks) will be examined with regard to feasibility, safety and clinical efficacy in patients suffering from chronic tinnitus in an one-arm pilot trial.

Eligibility Criteria:
Inclusion criteria:

* diagnosis of bothersome, subjective chronic tinnitus
* diagnosis: duration of tinnitus more than 6 months

Exclusion criteria:

* objective tinnitus
* irregular head shap below the electrodes
* eczema on the head
* treatable cause of the tinnitus
* involvement in other treatments for tinnitus at the same time
* clinically relevant psychiatric comorbidity
* clinically relevant unstable internal or neurological comorbidity
* history of or evidence of significant brain malformation or neoplasm, head injury
* cerebral vascular events
* neurodegenerative disorder affecting the brain or prior brain surgery
* metal objects in and around body that can not be removed
* pregnancy
* alcohol or drug abuse
Pembrolizumab Plus Neoadjuvant Chemotherapy for Locally Advanced EGJ Adenocarcinoma

The purpose of this study is to observe and evaluate the efficacy and safety of pembrolizumab plus cisplatin and 5-fluorouracil (5-FU) followed Surgery for locally advanced adenocarcinoma of esophagogastric junction

The neoadjuvant chemotherapy/chemoradiotherapy with surgery is the standard treatment in NCCN guideline. But many patients refused or abandon radiotherapy because of the intolerable adverse effects. We designed a single-arm, open-label, phase II trial of pembrolizumab plus cisplatin and 5-fluorouracil (5-FU) followed by radical surgery for locally advanced adenocarcinoma of esophagogastric junction. The purpose of this study is to observe and evaluate the efficacy and safety.

Eligibility Criteria:
Inclusion Criteria:

1. Histologically confirmed AEG, Siewert type I or II;
2. Potentially resectable cT3-4a, any N, M0 (AJCC 8 TNM classification);
3. Have a performance status of 0 or 1 on the ECOG Performance Scale;
4. Age 18-75 years old, both men and women;
5. Be willing and able to provide written informed consent/assent for the trial;
6. Demonstrate adequate organ function , all screening labs should be performed within 10 days of treatment initiation;
7. Female subject of childbearing potential should have a negative urine or serum pregnancy within 72 hours prior to receiving the first dose of study medication. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required;
8. Be willing to provide tissue from a newly obtained core or excisional biopsy of a tumor lesion through repeated biopsies. Newly-obtained is defined as a specimen obtained up to 4 weeks (28 days) prior to initiation of treatment on Day 1. Subjects for whom newly-obtained samples cannot be provided (e.g. inaccessible or subject safety concern) may submit an archived specimen only upon agreement from the Sponsor.

Exclusion Criteria:

1. Prior therapy (operation, radiotherapy, immunotherapy, or chemotherapy) for AEG;
2. Ineligibility or contraindication for esophagectomy;
3. Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study drug;
4. Has active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs);
5. Has severe hypersensitivity and adverse events (≥Grade 3) to nivolumab and/or any PD-1/PD-L1 inhibitors.
Gastric Ultrasound Assessment for Preoperative Prandial State of Patients Taking Glucagon-Like Peptide-1 Receptor Agonists

The purpose of this study is to determine the type of gastric content and quantify the volume of liquid gastric contents using ultrasonography in patients on GLP-1 agonists that have presented for elective surgery and to determine if risk factors are associated with a higher gastric volume in patients on GLP-1 receptor agonists.


Eligibility Criteria:
Inclusion Criteria:

* Patients taking GLP-1receptor agonists (N=62)
* Patients not taking GLP-1 receptor agonists (N=62)

Exclusion Criteria:

* Previous gastric resection or bypass
* Gastric band in situ
* Previous fundoplication
* Large hiatal hernia
* Pregnant patients
* Recent trauma
* Inability to turn to the right lateral decubitus position
Transcutaneous Electrical Acupoint Stimulation to Improve Pregnancy Rates for Women Undergoing in Vitro Fertilization

The objective of this study is to investigate the effect of transcutaneous electrical acupoint stimulation on pregnancy rates in women undergoing in vitro fertilization.


Eligibility Criteria:
Inclusion Criteria:

(1) infertile women \< 40 years of age, undergoing a fresh IVF or intracytoplasmic sperm injection (ICSI) cycle; (2) be an appropriate candidate with the potential for a lower success rate which defined as two or more previous unsuccessful ETs (fresh or frozen); (3) are willing to sign an informed consent form, indicating that they are aware of the investigational nature of this study that is in keeping with the policies of the institution; (4) willing to return to the study site for their study visits. The reason for our inclusion criteria is that women experienced several unsuccessful OAs or ETs may easily accept randomization to this study, and for whom adding TEAS or EA may significantly improve their clinical outcomes.

Exclusion Criteria:

(1) major medical illnesses (like stage III heart disease, severe hypertension, uncontrolled diabetes mellitus, HIV positivity, severe bleeding dyscrasias, etc.) possibly precluding IVF or pregnancy; (2) FSH more than 20 IU/L; (3) receiving donor eggs; (4) cutaneous lesion of certain acupoint area; (5) having been previously participated in this study or having undertaken acupuncture (in whatever modality) treatment for infertility.
Prediction of Difficult Mask Ventilation Using 3D-Facescan and Machine Learning

The aim of this study is to prove feasibility and assess the diagnostic performance of a machine learning algorithm that relies on data from 3D-face scans with predefined motion-sequences and scenes (MASCAN algorithm), together with patient-specific meta-data for the prediction of difficult mask ventilation. A secondary aim of the study is to verify whether voice and breathing scans improve the performance of the algorithm. From the clinical point of view, we believe that an automated assessment would be beneficial, as it preserves time and health-care resources while acting observer-independent, thus providing a rational, reproducible risk estimation.


Eligibility Criteria:
Inclusion Criteria:

* Patients scheduling for ENT or OMS surgery in general anaesthesia, who require facemask ventilation and tracheal intubation after induction of anesthesia
* Patients aged at least 18 years
* Ability to understand the patient information and to personally sign and date the informed consent to participate in the study
* The patient is co-operative and available for the entire study
* Provided informed consent/patient representative

Exclusion Criteria:

* Pregnant or breastfeeding woman
* Rapid sequence induction or other contraindications for facemask ventilation
* Planned awake tracheal intubation
The Zeaxanthin and Visual Function Study

To evaluate if supplementation of zeaxanthin (with or without Lutein) is beneficial to patients with early and moderate Atrophic Age Related Macular Degeneration.

To evaluate whether or not zeaxanthin supplementation raises macular pigment optical density (MPOD). Previous research has shown MPOD to mirror visual benefits for patients with age related atrophic macular degeneration (AMD) having visual symptoms (decreased visual acuity, contrast sensitivity, photostress glare recovery and National Eye Institute Visual Function Questionnaire 25 scores), but lower risk National Eye Institute (NEI) / Age Related Eye Disease Study (AREDS) characteristics.

Eligibility Criteria:
Inclusion Criteria:

* diagnosis of atrophic AMD (ICD9 362.51) by stereo bio-ophthalmoscopy and at least one vision degrading visual-psychophysical abnormality associated with AMD in one or both eyes.
* clear non-lenticular ocular media (cornea, aqueous and vitreous)
* free of advanced glaucoma and diabetes or any other ocular or systemic disease that could affect central or parafoveal macula visual function

Exclusion Criteria:

* high risk retinal characteristics for advanced AMD or advanced AMD for which existing medical / surgical options are available
* presence of ophthalmologically significant active exudative, AMD pathology by fluorescein angiography but also a single large drusen, \>15, multiple intermediate drusen, parafoveal geographic atrophy or loss of vision in one eye due to advanced AMD
* recent (within 6 months) cataract or retinal surgery
* taking photosensitizing drugs such as phenothiazines and chloroquine
* having taken lutein or zeaxanthin supplements within the past six months.
Engineering an Online STI Prevention Program: RCT

The overall objective of the proposed research is to reduce the incidence of sexually transmitted infections (STIs) among college students. The investigators propose to accomplish this by using the innovative, engineering-inspired multiphase optimization strategy (MOST) to develop a highly effective, appealing, economical, and readily scalable internet-delivered behavioral intervention targeting the intersection of alcohol use and sexual risk behavior. The rate of STIs on college campuses is alarming: one in four college students is diagnosed with an STI at least once during their college experience. Sexual activity when drinking alcohol is highly prevalent among college students. Alcohol use is known to contribute to the sexual risk behaviors that are most responsible for the transmission of STIs, namely unprotected sex, contact with numerous partners, and "hook-ups" (casual sexual encounters). Few interventions have been developed that explicitly target the intersection of alcohol use and sexual risk behaviors, and none have been optimized. In order to reduce the incidence of STI transmission among this and other high-risk groups, a new approach is needed. MOST is a comprehensive methodological framework that brings the power of engineering principles to bear on optimization of behavioral interventions. MOST enables researchers to experimentally test the individual components in an intervention to determine their effectiveness, indicating which components need to be revised and re-tested. Given the high rates of alcohol use and sex among college students, the college setting provides an ideal opportunity for intervening on alcohol use and sexual risk behaviors. The proposed study will include a diverse population of college students on 4 campuses which will increase the generalizability of the findings. The specific aims are to (1) develop and pilot test an initial set of online intervention components targeting the link between alcohol use and sexual risk behaviors, (2) use the MOST approach to build an optimized preventive intervention, and (3) evaluate the effectiveness of the newly optimized preventive intervention using a fully powered randomized controlled trial (RCT). This work will result in a new, more potent behavioral intervention that will reduce the incidence of STIs among college students in the US, and will lay the groundwork for a new generation of highly effective STI prevention interventions aimed at other subpopulations at risk.

As part of the MOST approach, the investigators have conducted two optimization trials (NCT02897804 and NCT 03408743) to identify the optimized intervention. The current study is the randomized controlled trial of the optimized intervention.

Eligibility Criteria:
Inclusion Criteria:

* Currently enrolled at an American college or University
* A first-year college student
* 18 years or older
* Have not gone through previous versions of itMatters

Exclusion Criteria:

* Not a first year student or transfer student
* Younger than 18 years old
* Have gone through previous versions of itMatters
Exercise Capability and Training Effects in Diabetic Patients With Neuropathy

The purpose of the study was to investigate the effects of training on the exercise capability, balance performance, and microcirculation. Furthermore, to search the possible underlying mechanisms.


Eligibility Criteria:
Inclusion Criteria:

* Type 2 diabetes with neuropathy.

Exclusion Criteria:

* Central nerve system dysfunction, hemiparesis, motion tremor, other musculoskeletal disease that might effect the outcome measurements.