cyrilzakka/clinical-trials huggingface dataset:
A Phase I Study of RGT-419B in Patients With HR-Positive, HER2-Negative Advanced Breast Cancer or Other Solid Tumors

This is a Phase 1 dose escalation and dose expansion phase I study to evaluate the safety, tolerability, pharmacokinetic profile and preliminary efficacy of RGT-419B as monotherapy in Chinese patients with HR+/HER2- advanced/metastatic breast cancer and other advanced solid tumors.


Eligibility Criteria:
Inclusion Criteria:

* Male or female ≥ 18 years of age
* Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1
* Subjects with pathologically confirmed advanced solid tumors who have failed standard-of-care therapy, or have no standard-of-care therapy available, or are currently not eligible for standard-of-care therapy; Subjects with HR+/ HER2- advanced or metastatic breast cancer are preferred.
* Estimated life expectancy of at least 12 weeks

Exclusion Criteria:

* Presence of visceral metastases with severe organ dysfunction
* Known active hepatitis B or C infection
* Prior irradiation to \>25% of the bone marrow and/or inadequate bone marrow function or evidence of clinicallysignificant end-organ damage
* History of allergic reactions attributed to compounds of similar chemical or biologic composition to the drugs usedin the study
Safety and Performance of SoftOx Wound Irrigation Solution (SWIS) in Acute Wounds

This pilot study evaluates safety and performance of the Medical device, SoftOx Wound Irrigation Solution (SWIS), in a model for acute wounds.

This is a pilot study with an open-label, exploratory study design with the aim to document preliminary safety and performance of the SoftOx Wound Irrigation Solution while used as intended by the manufacturer, i.e. as an irrigation solution for mechanical rinsing of breached or compromised skin as a result from acute wounds. This first-in-man study will give valuable information on the feasibility of the treatment with the SoftOx Wound Irrigation Solution to prepare for continuous studies in clinically significant settings prior CE marking. The investigation population will consist of 12 subjects undergoing split skin graft transplantation for treating chronic leg ulcers and that are fulfilling the eligibility criteria for the clinical investigation. The SoftOx Wound Irrigation Solution will be applied on the donor site of the split skin graft which is a representative model of acute wounds in a controlled setting. All subjects will be followed up for 21 days. The duration of the investigation is estimated to 4 months.

Eligibility Criteria:
Inclusion Criteria:

1. Age 18 and older
2. Non-healing, leg ulcers, that are scheduled for an operation with excision of the chronic leg ulcer and split skin transplantation
3. Been informed of the nature, the scope and the relevance of the clinical investigation
4. Voluntarily agreed to participation and has duly signed the Informed Consent Form

Exclusion Criteria:

1. Participating in any other clinical investigation
2. On systemic immunomodulating drugs
3. On systemic steroid treatment up to four (4) weeks prior to study inclusion
4. On strong pain medication (e.g. opioids)
5. Severe neuropathy (or dysesthesia on the donor site)
6. Pregnancy
7. Dementia
8. Allergy to polyurethane foam, hypochlorous acid, acetic acid or any other remedies/material used in the clinical investigation
9. Not able to read or understand Danish
10. Any other conditions that as judged by the investigator may make follow-up or investigation inappropriate
11. That according to the Declaration of Helsinki is deemed unsuitable for study enrolment
Inspiratory Muscle Therapy in Subjects With Fontan Circulations

Individuals who have undergone the Fontan procedure are uniquely dependent upon respiratory mechanics to support pulmonary blood flow (PBF). The investigators hypothesized that enhanced respiratory muscle function via inspiratory muscle training (IMT) would improve performance on cardiopulmonary exercise stress testing (CPET).

Adult Fontan subjects were recruited from 2 academic medical centers. Following characterization of pulmonary function and functional class, CPET was performed using incremental and constant work rate protocols. Subjects performed 6-8 weeks of IMT using a handheld inspiratory loading device (Threshold®, Philips); both exercise tests were then repeated. Patient-centered outcome data were collected before and after IMT (RAND-36 assessment and New York Heart Association (NYHA) functional class).

Eligibility Criteria:
Inclusion Criteria:

Single ventricle physiology status post Fontan palliation

Exclusion Criteria:

* The presence of a sub-pulmonary ventricle
* Pregnancy or any contraindication to stress testing (e.g., uncontrolled symptomatic arrhythmia, severe systemic ventricular outflow tract obstruction or uncontrolled symptomatic heart failure).
* Height less than 4'11" due to limitations of the cycle ergometer.
Integrating Food Rx With Best Feeding Practices With EFNEP

To assess feasibility and acceptability of of integrating Food Rx and Best Feeding Practices with EFNEP participants via a pilot study.

The purpose of the pilot study is to test the FFYF feeding curriculum material and procedures for implementation, staff training, recruitment, and data collection.

Eligibility Criteria:
Inclusion Criteria:

* Living in Harris or Fort Bend counties
* being a parent of a child 4-8 years old
* ability to speak in English or Spanish
* have ready access to a telephone
* have access to the Internet with a smart phone, a tablet, a laptop, or a desktop computer

Exclusion Criteria:

* parents of children with disabilities and/or those on prescription medications that affect weight and/or appetite
* parents who are not able to complete self-report questionnaires
A Phase I Study to Evaluate the Pharmacokinetics of Multiple Doses of Varenicline in Healthy Adolescent Smokers

This study will investigate the multiple dose pharmacokinetics, safety, and tolerability of two dose strengths of varenicline in adolescents aged 12 to 16 years who regularly smoke at least three cigarettes per day.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male and female adolescents (12 - 16 years inclusive) with a total body weight greater than 30 kg who currently smoke an average of at least 3 cigarettes per day.

Exclusion Criteria:

* Male and female subjects with a positive urine drug screen and female subjects with a positive pregnancy test.
Atopic Dermatitis: Sub-Saharan Africa vs. Central Europe

Many people are affected by atopic dermatitis (AD) worldwide. However, clinical studies on AD in Sub-Saharan Africa are rare and there is a lack of knowledge about possible differences in pathogenesis between European and African AD.

This study will collect clinical and laboratory data with the aim to compare clinical characteristics and immune responses in AD patients in Sub-Saharan Africa and Central Europe. Furthermore, relevant allergens as well as the nasal, skin and gut micro- and mycobiome will be investigated.

Objectives of the project: Compare the following aspects in patients suffering from atopic dermatitis (AD) and healthy control (HC) participants in Central Europe (CE) vs. Sub-Saharan Africa (SsA):

* Clinical characteristics, life quality, treatments, and family history
* Immune mapping and barrier characterization of lesional and non-lesional skin
* Exploration of the serological and cutaneous immune signatures
* Investigation of the skin, nasal and gut microbiome (including bacteria and fungi)
* Comparison of the sensitization patterns and putting it into clinical context (food questionnaire, anamnesis about allergic symptoms, analysis of IgE and IgG levels)

Eligibility Criteria:
Inclusion Criteria:

AD patients:

* Age: ≥18 years
* Written informed consent given after information about the research project
* Suffering from active atopic dermatitis
* No active skin disease other than atopic dermatitis
* No known active inflammatory disease other than atopic dermatitis/atopic diseases

HC participants:

* Age: ≥18 years
* Written informed consent given after information about the research project
* No active skin disease
* No known atopic disease (atopic dermatitis, asthma, allergy, allergic rhinoconjuncitivitis)
* No known active inflammatory disease

Exclusion Criteria:

* Known or suspected systemic immunosuppression because of disease
* Systemic immunomodulatory/-suppressive treatment

  * Glucocorticoids or immunosuppressants (last 4 weeks) or
  * JAK inhibitors (last week) or
  * Omalizumab (last 4 weeks) or
  * Other biologicals e.g. dupilumab (last 2 months)
* Clinical signs of active bacterial, fungal or viral infection
* Systemic antibiotic, antimycotic or antiviral treatment 4 weeks prior to start
* Phototherapy 4 weeks prior to start
* Active neoplasia
* Undergoing surgery in the last 2 months
* Infarction (e.g. stroke), embolism, or thrombosis in the last 2 months
* Inability to follow the study procedures e.g. due to language problems, dementia etc. of the participant
Adjuvant Melatonin for Prevention of Lung Cancer Recurrence and Mortality

There is evidence to support the use of melatonin, a natural health product, as an additional treatment aid for cancer patients. This study is designed to see if the daily ingestion of 20 milligrams of melatonin for one year can lower the incidence of developing lung cancer recurrence and/or death. Only patients with a diagnosis of non small cell lung cancer who are eligible for surgical resection can participate in the trial. The study will also be assessing for changes in quality of life, pain, fatigue, anxiety, sleep, and depression amongst the participants.

The trial employs a two-armed parallel placebo controlled trial design whereby patients with a diagnosis of non small cell lung cancer are randomized to receive either 20 mg of melatonin nightly or an identically matched placebo. All patients will be followed for two years with primary outcomes assessed at a two year time point and secondary outcomes evaluated throughout the course of the trial.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of non small cell lung cancer
* Eligible for surgical resection
* Willingness to adhere to randomized treatment
* Availability for follow-up schedule of visits

Exclusion Criteria:

* Taking exogenous melatonin
Prevention of Weight Gain in University Students

This study assess whether a small-group seminar intervention to prevent weight gain is effective in a general university student population, and to address the relative role of biological vs. lifestyle factors in predicting weight gain in humans.


Eligibility Criteria:
Inclusion Criteria:

* First year students at the Université de Sherbrooke.

Exclusion Criteria:

* Presence of diseases or medications that would be expected to affect weight (cystic fibrosis, diabetes, inflammatory bowel diseases, anorexia nervosa, bulimia, etc.).
* Pregnancy or planning a pregnancy in the next two years.
* Unable to give an informed consent.
Maxillary Sinus Augmentation by Xenograft Mixed With Melatonin

The possibility of enhancing the bone substitute in the maxillary sinus by mixing it with the melatonin to allow proper implant placement in early stage .

The aim of the study was to evaluate clinically, radiographically and histologically the effect of melatonin in enhancement of bone healing after augmentation of the maxillary sinus.

This study was include 16 severely atrophied maxillary sinus, with alveolar bone height less than 4mm, that need sinus augmentation and delayed implant placement, they were be equally and randomly distributed into 2 groups (via : http://www.randomizer.org) :

Group A: sinuses was received sinus membrane elevation using lateral window technique and filling the sinus with the mixture of melatonin and xenograft.

Group B: sinuses was received sinus membrane elevation using lateral window technique and filling the sinus with xenograft.

After 6 months, bone biopsies was collected from the augmented sinuses immediately before implant instalment in the same visit.

Initial cone beam computerized tomography was taken preoperatively and immediate postoperatively.

Final cone beam computerized tomography was taken 6 months before implant placement to measure Bone density and bone height and width.

After 3 months of implant placement, the installed implants was assessed clinically to exclude any infection or dehiscence and radio graphically to assess the bone loss or any radiolucent lesion around the implants and then prepared for loading.

Eligibility Criteria:
Inclusion Criteria:

1. Adult male/female patients above the age of 25.
2. Patients with one or more teeth requiring implant supported dental restoration in atrophic maxilla (unilateral or bilateral).
3. Alveolar bone height less than 4 mm at the defective site.
4. Good oral hygiene.

Exclusion Criteria:

1. Medically compromised patients with conditions contraindicating surgery (eg. uncontrolled diabetics, bisphosphonate intake, radio or chemotherapy).
2. Patients with active infection at or related to the site of surgery (eg. acute sinusitis).
3. Heavy smokers.
4. Patients not indicated for an implant supported restoration at the time of enrollment (eg. active/untreated periodontal disease).
A Novel Technique of Circumcision Incision Orchidopexy

Given that both circumcision and orchidopexy are commonly done in a single setting, the investigators adopted the technique of orchidopexy via circumcision incision, particularly for palpable low inguinal cryptorchidism. In this paper, the investigators aim to present a novel technique and discuss our preliminary outcome of such procedure compared to the traditional inguinal-scrotal double incision technique. Specifically, the investigators aimed to determine the differences in operative time, testicular size changes, peri-operative complications, pain score and parent's satisfaction of both novel technique and conventional orchidopexy.

Cryptorchidism is the most common disorder of the male endocrine gland in children.. 1 According to the latest guideline by European Association of Urology in the Pediatric Urology for the treatment of cryptorchidism, both inguinal and scrotal approaches orchidopexy are accepted standard treatment options. 2 In the local setting, circumcision is another common surgical procedure among the children, particularly under the same instance of anesthesia for other procedure. Not only due to religious and sociocultural reasons, male circumcision has been recently considered having a protective effect against acquisition of various sexually transmitted infections (STIs). 3 This benefit is one of many that have led to many affirmative evidence-based policy statements by medical bodies in support of the procedure.

Given that both procedures are commonly done in a single setting, we adopted the technique of orchidopexy via circumcision incision, particularly for palpable low inguinal cryptorchidism. In this paper, we aim to present a novel technique and discuss our preliminary outcome of such procedure compared to the traditional inguinal-scrotal double incision technique. Specifically, we aimed to determine the differences in operative time, testicular size changes, peri-operative complications, pain score and parent's satisfaction of both novel technique and conventional orchidopexy.

Eligibility Criteria:
Inclusion Criteria:

* Children diagnosed with palpable cryptorchidism with pre-operative inguino-scrotal ultrasound to confirm the location of the testis on the low inguinal canal and its viability.

Exclusion Criteria:

* Excluded were non-palpable testis, with prior orchidopexy, circumcised, with other concomitant genital anomalies.
Exploratory Study Comparing ClearSight System 2D Map to Post Surgery Histopathological Analysis in Lumpectomy

Prospective, single-arm, multicenter, open label, non-randomized exploratory clinical study comparing ClearSight system to histopathological to determine negative-margins in breast conserving surgery.

This study is a multicenter, non-randomized, cross-sectional comparative exploratory study comparing the ClearSight System 2D map results to post surgery histopathological analysis of excised mass in lumpectomy surgery. The Efficacy Objective is to assess the ability of the ClearSight™ System to detect malignant tissue less than or equal to 1 mm of margins of excised breast specimen in breast conserving surgery using histopathological assessment as reference. The Safety Objective is that all adverse events, serious adverse events (SAE) will be reported according to local regulations. The actual reporting is discussed in section 0. No device-related adverse events are expected. For more information please refer to the Investigator Brochure.

Eligibility Criteria:
Inclusion Criteria:

1. Women histologically diagnosed with carcinoma of the breast, scheduled for primary lumpectomy (partial mastectomy) procedure.
2. Age ≥18.
3. Signed ICF

Exclusion Criteria:

1. Prior surgical procedure in the same breast within 12 months prior to the surgery date.
2. Recurrent breast cancer surgery.
3. Neoadjuvant chemotherapy.
4. Previous radiation therapy to the operated breast.
5. Pregnant / breast feeding.
6. Participating in any other study that might affect results.
Safety and Efficacy of Inhaled Insulin in Type 2 Diabetes

This trial is conducted in Asia, Europe and South America. The aim of this research is to compare the efficacy (reduction in HbA1c and blood glucose) and pulmonary safety (pulmonary function tests, chest x-rays) of mealtime inhaled insulin with subcutaneous insulin aspart both in combination with insulin detemir in Type 2 Diabetes.

The decision to discontinue the development of AERx® is not due to any safety concerns. An analysis concluded that fast-acting inhaled insulin in the form it is known today, is unlikely to offer significant clinical or convenience benefits over injections of modern insulin with pen devices.

Eligibility Criteria:
Inclusion Criteria:

* Type 2 diabetes
* Currently treated with insulin
* Body mass index of (BMI) less than or equal to 40.0 kg/m2
* HbA1c less than or equal to 11.0%

Exclusion Criteria:

* Total daily insulin dosage less than or equal to 100 IU or U/day
* Current smoking or smoking within the last 6 months
* Cardiac problems
* Uncontrolled hypertension
* Current proliferative retinopathy or maculopathy
A Multicenter Trial of Radiofrequency Ablation vs. Surgery as Treatment of Papillary Thyroid Microcarcinoma.

The treatment of Papillary Thyroid Microcarcinoma (PTMC) nowadays varies among physicians, surgeons and radiologist. The recently published articles show that the prognosis of PTMC by different means of treatment strategies tends to be good. But multicentered, randomized, parallel and prospective study is rare. RFA is the abbreviation of "Radiofrequency Ablation", which tends to be an alternative strategy except conventional surgery. The investigator aims to confirm whether RFA for treating PTMC braces same effectiveness and prognosis comparing with conventional surgery. Besides, this trial also investigates the safety, economy and psychological quality under different treatments.

The incidence of thyroid carcinoma, especially the papillary thyroid microcarcinoma (PTMC), has increasingly rapidly, due to the development of technologies of diagnosis, during the past 20 years. PTMC defined by the World Health Organization (WTO) as the largest dimension less than 1 cm. Previous autopsy study demonstrated that the lesions are normal in many people and accompany them latently until they die because of another reasons. The long-term outcome of PTMC is good and, as expected, more than 90% PTMC aren't progress for many years.

Ultrasound-guided Radiofrequency Ablation (RFA) treatment was introduced to clinical practice few years ago. According to the 2015 American Thyroid Association (ATA) guideline, the treatment of radiofrequency and laser ablation are mentioned to be used in recurrent thyroid cancer. But clinical practice shows that the RFA treatment for low risk PTMC braces well effect，low financial budget，high safety and even rare postoperative complication.

Although the cohort study was performed before, the real answer concerning about whether RFA is a rational choice for treating PTMC lacks more powerful evidences. The investigator considers to perform a randomized, controlled and multicenter study as a high-quality evidence and demonstrated the effect of PRF in low risk PTMC treatment.

Eligibility Criteria:
Inclusion Criteria:

* Newly diagnosis of PTMC (largest dimension\<10mm)
* Age \>=18 years old
* Bethesda Category V or VI
* Single nodule without thyroid capsule contact
* Nodule has more than 3mm distance far from recurrent laryngeal nerve, carotid artery and trachea.
* No clinical evidences show there is local or distant metastasis.
* Without chemotherapy, radiotherapy and other related therapies.
* Patients and their family member totally understand and sign the informed consent.

Exclusion Criteria:

* Multifocal PTMC
* Combined with other types of thyroid cancer or hyperthyroidism.
* Contralateral vocal cord paralysis
* With local or distant metastasis
* Pregnant woman
* With radiation exposure history
International Multicenter Patent foRamen OVale & strokE (IMPROVE) Registry

Patent foramen ovale (PFO) is a prevalent cause of ischemic stroke and transient ischemic attack (TIA) in young patients. Its role as a cause of cerebrovascular events in the older population is more controversial because of other competing causes are more frequent in the elderly. Recent randomized controlled trials (RCTs) have shown that PFO closure is associated with a 59% relative risk reduction in the risk of recurrent ischemic stroke. As such, the number of PFO closure procedures are expected to increase substantially in the upcoming years. Real world data (RWD) informing on the medical management, the risk of stroke recurrence, incident atrial fibrillation, and other outcomes in stroke patients with PFO, with and without PFO closure, will become crucial for understanding how results from RCTs are translated into clinical practice globally.

The IMPROVE (International Multicenter Patent foRamen OVale \& strokE) Registry is an observational, multicenter, international registry of men and women with an ischemic stroke or TIA. The aim is to enroll 8,800 patient-years at ≥50 sites in ≥20 countries.

The IMPROVE Registry will provide important information about the management and related outcomes of patients with ischemic stroke or TIA and PFO throughout different regions of the world and across a wide spectrum of healthcare systems.


Eligibility Criteria:
INCLUSION CRITERIA (all of the following criteria should be fulfilled)

* Age ≥18 years
* Ischemic stroke or TIA within 5 years and 1 year before inclusion in the registry. Patients with cerebrovascular events occurred within one year before the inclusion in the registry should be part of the prospective cohort.

  * Ischemic stroke is defined as:

    * focal neurological deficit of central origin lasting ≥24 hours -except for death within 24hrs- with or without imaging confirmation of cerebral infarction; or
    * focal neurological deficit of central origin lasting \<24 hours with corresponding imaging evidence of cerebral infarction; or
    * focal neurological deficit of central origin lasting \<24 hours in patients receiving IV thrombolysis or endovascular thrombectomy with or without imaging confirmation of cerebral infarction; or
    * non-focal encephalopathy lasting more than 24 hours -except for death within 24hrs- with imaging evidence of cerebral infarction; or
    * acute and permanent retinal ischemia of arterial origin.
  * TIA is defined as:

    * focal neurological deficit of central origin lasting \<24 hours without corresponding imaging evidence of cerebral infarction in patients not receiving IV thrombolysis or endovascular thrombectomy.
* Confirmed patent foramen ovale.

EXCLUSION CRITERIA:

Exclusion Criteria

* Age \<18 years
* Venous stroke
* Stroke mimics
* Patients with incomplete data at 12 months after the index ischemic stroke or TIA.