cyrilzakka/clinical-trials huggingface dataset:
Rates of Hospitalization in Home Care Assisted Peritoneal Dialysis

We have developed and implemented a program that offers home care assistance to patients wishing to perform home peritoneal dialysis, but are unable to do it for themselves. This study is being conducted to ensure the safety of this dialysis program and specifically, to see if the risk of being hospitalized is increased when this therapy is provided to patients.

The cost of caring for patients with kidney failure is growing at an alarming rate and accounts for up to 7% of health care expenditures in developed countries. The majority of the cost is due to in-centre hemodialysis (HD) because of high operating costs and the capital investment required to build new dialysis units. In recent years, there has been a shortage of in-centre HD beds and it has become a priority to increase the number of patients being treated in their place of residence with therapies like peritoneal dialysis (PD). Unfortunately, many patients are unable to perform their own dialysis at home, a trend that will become more and more common as the population ages. We developed and implemented a program of home care assisted PD at Sunnybrook Health Sciences Centre where health care workers go into the home to assist patients with their treatment. The program has been a success and has garnered national attention. As a result, it has been adopted province-wide as part of the "Provincial PD Joint Initiative" and the Manitoba Renal Program is currently implementing a similar program to increase the use of PD.

However, based on preliminary data, we are concerned that patients treated with home care assisted PD may have higher rates of hospitalization when compared to traditional forms of treatment (23.5 days per year of follow-up compared to 13 days per year of follow-up. If this is true it could have a significant impact on patient quality-of-life, cost-savings associated with PD, and resource allocation and planning in regional dialysis programs. This is of particular concern given that the provincial initiative has a goal of increasing the proportion of patients being treated with PD from the current 18% to 30% by 2010.

The primary objective of this study is to determine if patients treated with home care assisted peritoneal dialysis are more likely to be hospitalized when compared to those treated with in-centre hemodialysis.

The secondary objective of this study is to compare the occurrence of important outcome events including the need for access-related procedures, technique survival, and death in patients on home care assisted peritoneal dialysis compared to in-centre hemodialysis.

Eligibility Criteria:
Inclusion Criteria:

1. 18 years of age or older
2. End-stage kidney disease in the opinion of the attending nephrologist
3. Deemed eligible for both home assisted PD and traditional in-centre HD following a multidisciplinary assessment, regardless of what therapy is chosen

Exclusion Criteria:

1. History of kidney transplant or expected to receive a transplant in the next 3 months
2. Expected to transfer to another regional dialysis program following the initiation of dialysis
Dose Study in Growth Hormone Deficient Adults Investigating Safety, Pharmacokinetics and Pharmacodynamics of NNC126-0083

This trial is conducted in Europe. The aim of this clinical trial is to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of NNC126-0083 in growth hormone deficient adults


Eligibility Criteria:
Inclusion Criteria:

* GHDA subjects as defined in the Consensus guidelines for the diagnosis and treatment of adults with GH deficiency II
* Fertile females must agree to use appropriate contraceptive methods and have a negative pregnancy test at inclusion
* GH replacement therapy for more than 3 months
* Body Mass Index (BMI, kg/m2) of 22.0 to 35.0 kg/m2, both inclusive

Exclusion Criteria:

* Females of childbearing potential who are pregnant, breast-feeding or intend to become pregnant or are not using adequate contraceptive methods
* Malignant disease
* Proliferative retinopathy judged by retina-photo within the last year - only with concomitant diabetes
* Heart insufficiency, NYHA class greater than 2
* Subjects with diabetes with an HbA1C above 8.0%
* Diabetic receiving insulin treatment
* Stable pituitary replacement therapy for less than 3 months
* Impaired liver function
* Impaired kidney function
Effectiveness of Tonsil Fossa Closure in Pain Relief After Tonsillectomy in Children

Objective: Postoperative pain is the main complaint in children undergoing tonsillectomy. An inexpensive method and with few evidence in the literature on effectiveness in reducing pain is the closure of the tonsillar fossa by suture with absorbable sutures. The investigators will compare the pain after tonsillectomy between closure or not the tonsil fossa.

Study design: Prospective, randomized, double blind, and controlled. Method: Two hundred otolaryngologic outpatients with indication of bilateral tonsillectomy for repeated tonsillitis, tonsillar hypertrophy or sleep apnea between 5 and 12 years old will be enrolled from November 2015 to July 2016. The procedure will be performed by a single surgeon and similar postoperative medications will be prescribed. There will be two techniques: closure or not of the tonsillar fossa with catgut points. A questionnaire containing a Faces Pain Scale - filled 1 and 7 days after surgery- and other data - difficulty of detachment of the palatine tonsils, hemostasis technique, surgical complications, healing characteristics, day of total improvement of the pain, day of beginning of normal food intake, presence of postoperative bleeding, complications and observations raised by the patient - will be applied.


Eligibility Criteria:
Inclusion Criteria:

* no cognitive-intellectual changes;
* capacity to respond the questionnaire;
* able to help in the study

Exclusion Criteria:

* conducting invasive procedure for less than two months;
* history of any infection during last month;
* continuous use of any medication;
* postoperative fever;
* non-standard medication prescribed for the postoperative time
Clobetasol Propionate 0.05% Shampoo in Association With Antifungal Shampoo in Scalp Seborrheic Dermatitis

The objective is to assess different treatment regimens with Clobetasol propionate shampoo 0.05% in the treatment of scalp Seborrheic Dermatitis.

The objective is to assess different treatment regimens with Clobetasol propionate shampoo 0.05% in association with an antifungal shampoo (Ketoconazole 2%) in the treatment of moderate to severe scalp Seborrheic Dermatitis compared to the antifungal shampoo alone.

Eligibility Criteria:
Inclusion Criteria:

* Subjects with moderate to severe scalp Seborrheic Dermatitis

Exclusion Criteria:

* Subjects suffering from psoriasis,
* Subjects with a known allergy to one of the components of the test products,
* Female subjects who are pregnant, nursing or planning a pregnancy during the study
Ceftobiprole in the Treatment of Pediatric Patients With Pneumonia

This was a study of the safety and efficacy of ceftobiprole medocaril compared with intravenous (IV) standard-of-care cephalosporin treatment with or without vancomycin in pediatric patients with either hospital-acquired bacterial pneumonia (HAP) or community-acquired bacterial pneumonia (CAP) requiring hospitalization, and requiring intravenous (IV) antibiotic therapy.

This was a randomized, investigator-blind, active-controlled multi-center study to evaluate the safety, tolerability, pharmacokinetics and efficacy of ceftobiprole medocaril compared with IV standard-of-care cephalosporin treatment with or without vancomycin in pediatric patients aged 3 months to less than 18 years with HAP or CAP requiring hospitalization and therapy with IV antibiotics. Randomization was stratified by four age groups (3 months to \< 2 years; 2 years to \< 6 years; 6 years to \< 12 years; 12 years to \< 18 years), and by diagnosis of HAP or CAP.

Eligibility Criteria:
Inclusion Criteria:

* Male of female aged 3 months to \< 18 years with a body weight of at least 5 kg
* Diagnosis of either hospital-acquired pneumonia or community-acquired pneumonia requiring hospitalization and administration of IV antibiotic therapy
* New or progressive imaging findings consistent with bacterial pneumonia
* Requirement for IV antibacterial treatment for pneumonia
* Other inclusion criteria may apply

Exclusion Criteria:

* Known resistance of the causative pathogen to ceftobiprole or IV standard-of-care cephalosporin treatment (± vancomycin)
* On mechanical ventilation
* Chest trauma with severe lung contusion or flail chest
* Acute respiratory distress syndrome
* Empyema or lung abscess
* Anatomical bronchial obstruction
* Active or currently treated pulmonary tuberculosis
* Atypical bacterial pneumonia, or viral pneumonia without bacterial superinfection, or need for antibiotic coverage with a macrolide
* Pertussis, chemical pneumonitis, or cystic fibrosis
* Severe immunodeficiency
* Significant laboratory abnormalities including: Hematocrit \<20%; absolute neutrophil count \<0.5x10⁹/L; platelet count \<50x10⁹/L; alanine aminotransferase, aspartate aminotransferase, or bilirubin \>5 times the age-specific upper limit of normal;
* Creatinine clearance \<50 mL/min/1.73 m²
* Use of systemic antimicrobial therapy for more than 24 hours in the 48 hours before randomization
* History of a previous clinically-relevant hypersensitivity or serious adverse reaction to beta lactam antibiotics or to vancomycin
* Poorly controlled seizure disorder
* Other exclusion criteria may apply
Facial Scanning for Lip Support Assessment in Full Arch Implant Rehabilitations

Lip support plays an important role in facial esthetics, being a relevant factor when realizing full arch implant supported rehabilitations. However, there is a lack of research on the three dimensional impact of such restorations.

As lip support is becoming more determinant in the facial esthetics outcome after full arch implant rehabilitation, there is a need to know the influence of said rehabilitation in the lower third profile of the patients. Then, through facial scanning, this study's purpose is to evaluate three dimensional changes that arise since the initial state that the patient presents to the office until is rehabilitated through 3D discrepancies and 2D linear measurements.

Eligibility Criteria:
Inclusion Criteria:

* Indication for full arch implant rehabilitation

Exclusion Criteria:

* Presence of facial hair, braces, make up, earrings or any facial deformity
Screening for Cystic Fibrosis and Cystic Fibrosis Related Disorders in Chinese Adults With Bronchiectasis

The study carries out Sweet Tests and CFTR-mutation screening to explore the prevalence, clinical characteristics, and prognosis of cystic fibrosis, as well as the CFTR-mutation spectrum in Chinese adults with bronchiectasis. The study is multi-centered, prospective, non-interventional, and observational.

The incidence of cystic fibrosis (CF) or CFTR dysfunction in China remains unclear due to the absence of a diagnosis and different genetic backgrounds. However, the CF case rate in western countries is relatively high, up to 1/2500. According to the limited statistics, the most common classic clinical symptom of Chinese CF patients is bronchiectasis. Other symptoms often seen in diseased western groups, such as pancreatic insufficiency, are rarely seen in Chinese patients. Thus, Chinese CF or CFTR dysfunction patients easily misdiagnose bronchiectasis, Chronic pneumonia, asthma, etc. Sweet test and CFTR-mutation screening are urgently needed for diagnosing and treating CF or CFTR dysfunction patients in Chinese adults with bronchiectasis. The study will focus on the change in CFTR function, genetic susceptibility factors, and disease progression to explore the incidence, clinical characteristics, and prognosis of cystic fibrosis, as well as the CFTR mutation spectrum in Chinese adults with bronchiectasis.

Eligibility Criteria:
Inclusion Criteria:

* Age\>18 years, the diagnosis of bronchiectasis needs a reference to the definition of "non-cystic fibrosis bronchiectasis guideline" published by the British Thoracic Society in 2017 or 2021 China bronchiectasis expert consensus, clinical symptoms of cough and expectoration, with or without intermittent hemoptysis, and chest CT showed bronchiectasis
* Patients who are willing to sign the consent form and participate in the study.

Exclusion Criteria:

* Patients with incomplete essential information, which is needed for the integrity of data analysis. Essential information includes CT images, respiratory sample cultures, spirometry, and exacerbation history for at least one year.
* Patients under 18 years old.

Sweat Test Exclusion Criteria:

* Patients with an implanted device, such as a defibrillator, neurostimulator, pacemaker, or ECG monitor.
* Patients with a history of epilepsy or seizures.
* Patients who are pregnant.
* Patients that have a known sensitivity or allergy to any ingredient.
* Over-damaged, denuded skin or other recent scar tissue.
* Patients with Cardiac Conditions or with suspected heart problems.
In-home Cycling for Individuals With PD: Feasibility

This study will examine the influence of social support on exercise frequency, duration, quality of life, and overall activity level.

The benefits of exercise for individuals with Parkinson disease (PD) have been well documented; however, individuals with PD living in rural and underserved urban settings are largely unable or unwilling to participate in group exercise programs due in large part to their distance from such programs and financial considerations. Additionally, community based programs which provide social support and engagement have been shown to benefit elderly individuals as well as individuals with pathology, but are equally unattainable to this group. Taking the exercise to these individuals via telemedicine or tele-exercise may be an ideal means of delivering this type of intervention.

The long-term goal of this project is to improve outcomes for underserved populations of individuals with Parkinson disease (PD) by providing access to in-home physical activity via a telehealth approach. Approximately one million Americans currently live with a diagnosis of PD and it has been estimated that delaying the progression by 20% would result in a $75,891 savings per individual based on reduced health care costs, income maintenance, increased duration of life and improved quality of life. However, individuals with PD of lower socioeconomic status, people of color and rural dwelling seniors have been critically underserved by clinical and academic programming resulting in poorer health outcomes.

This Study will examine the effects of social engagement during in-home exercise on a small sample of individuals with Parkinson Disease (PD). This pilot investigation will directly measure the effect of social support and engagement on exercise outcomes for rural dwelling individuals with PD.

Eligibility Criteria:
Inclusion Criteria:

* diagnosis of idiopathic "definite PD" based upon established criteria
* vision at or corrected to 20/40 or better
* ability to independently ambulate for at least 10 minutes continuously
* no reported vestibular or neurological disease (stroke or muscle disease) beyond their diagnosed PD
* score of greater than or equal to 78 (no evidence of dementia) on the telephone adaptation of the modified mini-mental state exam
* English Speaking

Exclusion Criteria:

* contraindication for exercise
* history of muscular or orthopedic diagnosis
* inability to participate in the full duration of the study
* currently exercising for 20 or more minutes per week
Cryoablation vs Thoracoscopic Surgery for GGN

The aim of this study is to investigate the efficacy and safety of Cryoablation and Thoracoscopic Surgery in the treatment of pulmonary ground-glass nodules.

The primary treatment for GGN type lung cancer is surgical resection, typically using video-assisted thoracoscopic surgery (VATS). Image-guided ablation therapy is considered as a treatment option for early-stage lung cancer patients unsuitable for surgery. It has been recommended by several guidelines as one of the curative treatment methods for primary lung cancer. Among various ablation techniques, cryoablation has the lowest complication rate. However, there is currently no research exploring whether cryoablation is not inferior to thoracoscopic surgery in terms of safety and efficacy in treating highly suspected malignant lung GGNs. This study was designed as a prospective, randomized controlled trial, with 160 patients expected to be enrolled in the study, randomized in a 1:1 ratio to cryoablation and thoracoscopic surgery treatment groups. The primary endpoint is the 2-year disease-free survival. Secondary endpoints include 1-month mortality rate, overall survival, 5-year disease-free survival, local recurrence rate, VATS/ cryoablation completion rate, safety, etc.

Eligibility Criteria:
Inclusion Criteria:

1. Patients ≥ 18 years old.
2. The size of the GGN was 6-20mm (with less than 25% solid component), and the number of nodules requiring treatment in the short term is less than 3.
3. Pathological confirmation of the GGN as non-small cell lung cancer; or progression of the GGN during at least 3 months of follow-up, including enlargement of the largest diameter, increase in solid component, or the appearance of a significant solid component in a previously pure GGN, with multidisciplinary discussion (including radiology, thoracic surgery, and pulmonology) suggesting malignancy.
4. No lymph node, pulmonary, or distant metastasis to other organs.
5. After multidisciplinary evaluation, the patient is considered capable of tolerating both surgical and ablation procedures.
6. Unsuitable for radiation therapy or refuses radiation therapy.
7. Willing to participate in this clinical study and sign the informed consent form.

Exclusion Criteria:

1. Patients in poor general condition, with ECOG physical fitness score \>2, unable to tolerate surgery or ablation therapy, or with relevant contraindications.
2. Patients who have previously received other treatments for pulmonary GGNs.
3. Patients with poor compliance.
4. Severe heart, lung, kidney, brain, or other vital organ diseases.
5. Active bacterial or fungal infections.
6. Simultaneous or metachronous (within the past 5 years) double cancers.
7. Women during pregnancy or breast-feeding.
8. History of prior lung surgery or radiation therapy.
9. Bleeding tendency, abnormal coagulation functions, or coagulation disorders that cannot be corrected after treatment.
10. Contraindications to general anesthesia.
11. Expected survival time \< 6 months.
12. The researcher believes that it is not suitable for inclusion.
A Study of ZN-c5 in Subjects With Breast Cancer

This is a Phase 1/2, open-label, multicenter, dose-escalation and expansion study to evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy of ZN-c5 administered orally in subjects with advanced estrogen receptor positive, human epidermal growth factor receptor 2 negative (ER+/HER2-) breast cancer. ZN-c5 will be evaluated both as monotherapy and in combination with palbociclib (IBRANCE®).


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years of age

  * Women can be postmenopausal, as defined by at least one of the following:
  * Age ≥ 60 years;
  * Age \< 60 years and cessation of regular menses for at least 12 consecutive months with no alternative pathological or physiological cause; and serum estradiol and follicle-stimulating hormone level within the laboratory's reference range for postmenopausal females;
  * Documented bilateral oophorectomy; or can be peri- or premenopausal, however, they must receive a gonadotrophin-releasing hormone agonist beginning at least 4 weeks prior to the first dose of study medication.
* Histologically or cytologically confirmed diagnosis of advanced (metastatic or locoregionally recurrent) adenocarcinoma of the breast, not amenable to any potential curative intervention
* Estrogen Receptor (ER) positive disease
* Human Epidermal Growth Factor Receptor 2 (HER2) negative disease
* Documented prior response to endocrine therapy for metastatic disease (stable disease, partial response, or complete response by RECIST v1.1 criteria) lasting \> 6 months
* Evaluable or measurable disease by RECIST v1.1. Tumor lesions previously irradiated or subjected to other locoregional therapy will only be deemed measurable if progression at the treated site after completion of therapy is clearly documented.

Exclusion Criteria:

* Prior anticancer or investigational drugs for the treatment of ER+/HER2 negative advanced breast cancer within the following windows:

  * Tamoxifen, aromatase inhibitor, fulvestrant, or other anti-cancer endocrine therapy \< 14 days before first dose of study treatment
  * Any chemotherapy \< 28 days before first dose of study, except for Phase 2 monotherapy which requires no prior chemotherapy treatment.
  * Any investigational drug therapy \< 28 days or 5 half-lives (whichever is shorter) prior to first dose of study treatment
* Unexplained symptomatic endometrial disorders (including, but not limited to endometrial hyperplasia, dysfunctional uterine bleeding, or cysts)
Identification of TT Cases by Community Treatment Assistants: An Assessment

To achieve the goal of trachoma control as mandated by the World Health Organization, countries must reduce the backlog of trichiasis surgery cases to less than 1/1,000 of their population. However, these cases reside in rural villages in trachoma endemic districts, and finding them to offer services is a challenge. Community Treatment Assistants (CTAs) are village residents who are trained to offer Mass Drug Administration (MDA) to their communities and hence are in contact with most residents. A training guide and tool for screening for trachomatous trichiasis (TT) will be developed to train CTAs in rural Tanzania to identify cases in their communities and refer them to surgery. Compared to the current process by which CTAs passively screen for TT if cases complaint, investigators hypothesize that the trained CTAs will identify twice the usual number of TT surgery cases during ongoing community antibiotic administrations for trachoma and will also miss fewer cases. If this simple system is effective, it can be implemented widely to screen communities for cases of TT.

Residents from thirty-six villages holding MDA, for whom a complete census is available, will be randomized on a 1:1 basis to intervention (where the CTAs receive the enhanced training from the enhanced training team) and usual assessment (where the CTAs receive the usual instructions from the regular MDA team). In both arms, the CTAs will keep records of all cases they have screened as positive for TT amongst the residents.

A Master TT grader will grade all screened cases of TT to determine the rate of true positivity in both arms.In addition, he will examine a random sample of residents who are screened as negative to detect potentially missed cases and estimate the total burden of trichiasis cases in both arms as well.The assessments of the Master TT grader will serve as the gold standard for calculations of sensitivity, specificity, and positive and negative predictive values of the enhanced training versus usual assessment methods.


Eligibility Criteria:
Inclusion Criteria:

* All persons in the study and control communities are eligible for the MDA.
* Adults aged 15 and over will be eligible for the survey and re-assessment.
* Those who are screened positive in the re-assessment will be eligible for treatment at the surgery camp.
* Those who are screened positive for TT initially but refuse the definitive re-screening will still be offered surgery but told they may not have TT and will be re-screened by the surgeon.

Exclusion Criteria:

* none