cyrilzakka/clinical-trials huggingface dataset:
Deposition of Inhaled Prolastin in Cystic Fibrosis Patients

The objective of this trial is to determine the optimal region of the lung for depositing Prolastin (alpha-1 antitrypsin; AAT) by inhalation in order to treat cystic fibrosis (CF). The AKITA® nebulizer has settings which can be varied to target the inhaled drug to either the deep lung or to the upper airways in a one to one randomization. The study will measure how much of the activity of the enzyme elastase is inhibited by AAT.

The optimum deposition site (bronchial or peripheral) in CF patients for AAT will be investigated by measuring several parameters in induced sputum. The study will start with a 2 week run-in period in which the planned 60 patients inhale isotonic saline once daily. This period is followed by a 4 week treatment period where 30 patients inhale AAT for peripheral deposition and 30 patients inhale AAT for bronchial deposition. Six patients in each group will be asked to collect spontaneous sputum at home.

Twenty-five milligrams of AAT will be deposited at one of the two target sites using the AKITA® device. The inhalation should take place in the evening between 18.00 and 23.00 h.

Patients will inhale saline once daily for 2 weeks (run-in period) followed by 4 weeks of once daily inhalation of AAT. Induced sputum will be collected at visits to the clinic at the start of the run-in, at the start of AAT treatment, and at 2 and 4 weeks after the start of AAT treatment.

Eligibility Criteria:
Inclusion Criteria:

* Patient with diagnosis of CF
* Age \>= 8 years
* Forced expiratory volume at one second (FEV1) \> 25 % of predicted value
* Free elastase activity checked at visit 1 must be positive (free elastolytic activity in the sample, 2 standard deviations above of the negative blank samples in the assay.) .
* Patient must be positive at least 3 times for pseudomonas in the last 2 years
* Patient must be positive for pseudomonas at Visit 1
* Patient must be able to perform reliable spirometry
* Patient must be on stable concomitant therapy at least 2 weeks prior to visit 1 and during the study
* Written informed consent of the patient or legal representative(s)

Exclusion Criteria:

* FEV1 \< 25% of predicted value post-bronchodilator
* History of lung transplant
* Any lung surgery within the past 2 years
* On any thoracic surgery waiting list
* Severe concomitant disease (serious malignant disease, congestive heart failure New York Heart Association (NYHA) III/IV, cor pulmonale with the need of oxygen therapy)
* Severe liver cirrhosis with ascites, hypersplenism or grade III/IV esophageal varices.
* Known selective immunoglobulin A (IgA) deficiency with known antibody against IgA (anti-IgA antibody)
* Active pulmonary exacerbation within the 4 weeks prior to screening
* Current Smoking
* Pregnancy or lactation
* Women of child-bearing age without adequate contraception
* Any medical condition which the investigator feels will prohibit the patient from completing the trial
* Participation in another clinical trial within 30 days prior to inclusion at visit 1
Direct and Spillover Impacts of a Community-Level HIV/AIDS Program

The HIV/AIDS crisis in Sub-Saharan Africa has left millions of children orphaned. These children, who are potentially infected with HIV themselves, are highly vulnerable and face some serious risks to their health and overall well-being.

A variety of health and economic interventions to help orphans and vulnerable children (OVCs) (and the households in which they live) are being carried out in Mozambique by World Education Inc./Bantwana (WEI/B), funded by USAID. The program is known in Portuguese as Força à Comunidade e Crianças or FCC (in English, "Strengthening Family and Communities").

This study will collect survey and administrative data to assess the impact of the FCC program on OVCs and the households in which they live. A baseline survey was administered to define a sample of households and individuals to follow over time through the upcoming follow-up survey and to measure baseline household characteristics.

Follow-up data collection will begin in March 2019. It has several components:

1. Household survey The follow-up survey will provide measurements of the rich set of intermediate and final outcomes for the estimation of treatment effects of the FCC program.
2. Data collection on HIV testing and school attendance This study will supplement survey-reported HIV testing rates with an objective, administrative measure of HIV testing at health clinics. At the time of the follow-up survey, the survey team will recommend that eligible individuals in the household be tested for HIV at a specified local health clinic. To allow tracking of those who follow through with testing, consenting individuals will be given coupons redeemable for a small financial incentive once they have completed an HIV test.

   In addition to self-reported data on school participation by children, this study will also measure school participation directly. Both school enrollment (presence in school registration records) and school attendance (physical presence of children in school during unannounced school visits by research staff) will be measured. Project staff will visit schools in study communities to check attendance rates of specific school-aged children who were listed in the baseline survey in their community.
3. Informational treatments aimed at raising HIV testing rates To allow insight into the mechanisms through which the FCC program has its effects, this study will provide additional simple treatments in the context of the follow-up survey to explore possible FCC mechanisms: stigma reduction, HIV/AIDS information, and HIV treatment (antiretroviral therapy, or ART) information.


Eligibility Criteria:
Inclusion Criteria:

* Households that lives in one of the eligible communities.

Exclusion Criteria:

* Households that are not in the eligible communities will not be included in the survey sample.
Ruxolitinib and Chidamide Intensified Bu/CY Conditioning Regimen

The purpose of this study is to determine the efficacy and safety of Ruxolitinib and Chidamide intensified conditioning regimen in patients with Acute B cell Lymphoblast leukemia Underwenting Haploidenticl Peripheral blood Stem Cell Transplantation.

Haploidenticl Peripheral blood Stem Cell Transplantation should be offered to eligible patients with Acute B cell Lymphoblast leukemia whenever feasible. To further improve the outcome of transplantation patients with Acute B cell Lymphoblast leukemia, we developed a modified Bu/Cy conditioning regimen intensified by Ruxolitinib and Chidamide. In this study, we tested the efficacy and feasibility of the modified Bu/Cy conditioning regimen intensified by Ruxolitinib and Chidamide in patients with Acute B cell Lymphoblast leukemia undergoing allogeneic peripheral blood stem cell transplantation.

Eligibility Criteria:
Inclusion Criteria:

1. high risk acute B cell lymphoblastic leukemia with the indications for allogeneic transplantation;
2. Have matched sibling donors, ≥8/10 HLA matched unrelated donors or haploidentical donors
3. All patients should aged 12 to 65 years;
4. Liver function: ALT and AST≤2.5 times the upper limit of normal , bilirubin≤2 times the upper limit of normal;
5. Renal function: creatinine ≤the upper limit of normal;
6. Patients without any uncontrolled infections , without organ dysfunction or without severe mental illness;
7. Eastern Cooperative Oncology Group (ECOG) performance status ≤2;
8. Have signed informed consent.

Exclusion Criteria:

1. pregnant women;
2. Patients with mental illness or other states unable to comply with the protocol;
3. ALL patients with Ph positive;
Developing an HIV Disclosure Intervention for Men in Uganda

The goal of this clinical trial is to test an HIV disclosure intervention that the investigators are developing focused on men living with HIV in Uganda. The main questions the investigators are trying to answer is whether the HIV disclosure intervention the investigators develop will help men who receive this intervention to disclose their HIV status to a greater extent than men who receive standard care.

Participants assigned to the intervention group will likely participate in the following:

* Sexual health education
* Cognitive behavioral therapy strategies
* Problem-solving skills building
* Motivational interviewing
* Developing a personalized HIV disclosure plan
* Communication skills building
* Role-playing disclosure strategies


Eligibility Criteria:
For all 3 Aims, "index participants" inclusion criteria will include:

* men living with HIV
* with sexually transmitted infection symptoms (e.g., urethral discharge, genital lesions)
* either not accessing antiretroviral therapy (per self-report109 and/or clinic documentation) or accessing antiretroviral therapy without HIV viral suppression
* age ≥18 years,
* with at least one sexual partner in the past three months

Aims 2 and 3 have the additional inclusion criteria:

* men living with HIV without HIV disclosure to at least one partner.

In Aims 2 and 3, male participants will be encouraged to invite sexual partners for enrollment. These "partner participants" will have the following inclusion criteria:

* age ≥18 years
* partnered with an enrolled man who reports HIV disclosure or plans for HIV disclosure with study support
* referred by the male participant.

Exclusion Criteria:

* an inability to speak the local language (Runyankole) or English
* an inability to provide informed consent
A Study of Atomoxetine for Attention Deficit and Hyperactive/Impulsive Behaviour Problems in Children With ASD

The primary purpose of this study is to evaluate the tolerability and effectiveness of atomoxetine in the treatment of attention problems, hyperactivity, and impulsivity in children with ASD, and secondarily, to evaluate the possible response to atomoxetine on the core symptoms of ASD


Eligibility Criteria:
Inclusion Criteria:

* Male and female outpatients between the ages of at least 6 years of age and not more than 17 years of age at visit 1
* Autistic Spectrum Disorder (DSM-IV TR) diagnosis of Autistic disorder or Asperger syndrome or PDDNOS
* Clinically significant symptoms of ADHD (i.e. inattention, impulsiveness, and hyperactivity) that have been present for at least six months (for subjects older than 8 years, the onset of symptoms must be before the age of 7 years)
* Medication-free for at least two weeks for all psychotropic medications (four weeks for fluoxetine or depot-neuroleptics)
* Patients must also be able to swallow capsules

Exclusion Criteria:

* Patients who weigh less than 20 kg or greater than 60 kg at visit 2
* DSM-IV TR diagnosis of a Pervasive Developmental Disorder other than Autistic Disorder, PDD-NOS, Asperger's Disorder (e.g. Rett's Disorder, Childhood Disintegrative Disorder)
* Patients who have a history of Bipolar I or II disorder, schizophrenia, psychosis
* Patients who have a current diagnosis of Major Depression (with or without psychotic features), PTSD
* Patients with a history of any seizure disorder (other than febrile seizures) or patients who have taken (or are currently taking) anticonvulsants for seizure control
A Real-World Study to Gain Clinical Insights Into Roche Ophthalmology Products

The VOYAGER study is a primary data collection, non-interventional, prospective, multinational, multicenter study. It is designed to collect real-world, long-term data to explore long-term effectiveness, safety, clinical insights, treatment patterns, and factors driving the treatment decisions among patients being treated with specified Roche ophthalmology products in approved retinal indications (Faricimab for neovascular age-related macular degeneration \[nAMD\], diabetic macular edema \[DME\], and retinal vein occlusion; Port Delivery System with Ranibizumab for nAMD) in routine clinical practice. This study will not provide or make recommendations on use of any products including Roche products; treatment decisions will be determined by the treating physician and must be made independently to the decision to participate in this study. Participation in this study will not change or influence a patient's standard of care in any way.


Eligibility Criteria:
Inclusion Criteria:

1. Have provided informed consent, as required per local regulations 2.a) Adult patient, as defined by local regulations and local product label, who is newly initiating treatment (or initiated treatment in the previous visit) with a specified approved Roche ophthalmology product in retinal indication of interest for this study in at least one eye, according to the investigator's discretion in routine clinical practice; OR 2.b) Adult patient, as defined by local regulations and local product label, who is continuing treatment with any specified approved Roche ophthalmology product in retinal indication of interest for this study in at least one eye after initiating that treatment in a Roche interventional trial.

Exclusion Criteria:

1. Concomitant participation of the patient in an investigational ophthalmology clinical trial that includes receipt of any investigational drug or procedure within the last 28 days prior to enrollment (this restriction does not apply to patients who are rolling over from Roche interventional studies and continuing treatment with any specified approved Roche ophthalmology product in retinal indication of interest for this study)
Comparison of the Effects of Turkish Get Up Exercise and Stabilization Exercises on Muscular Activation, Core Stability and Upper Extremity Performance in Healthy Individuals

Turkish Get Up (TGU) exercise, which is one of the kettlebell exercises, is a multi-step, progression-based, functional and whole-body exercise method that includes a combination of movements such as lunge, bridge building and side plank. Strength training, dynamic flexibility exercises and strength training can be performed with the use of a kettlebell. Exercises with a kettlebell are frequently used in the fields of improving sportive performance and rehabilitation. TGU exercise can be used as a corrective exercise as well as in motion analysis and conditioning studies. TGU exercise consists of 2 stages:The first stage is performed in seven different steps: 1. Starting position, 2. Supine kettlebell lift, 3. Elbow-supported kettlebell lift, 4. Hand-supported kettlebell lift, 5. High bridge, 6. Half-kneeling and lunge position, 7. Stand up. In the second stage, the exercise is completed by performing the return of the steps in the first stage. It is thought that the deltoid, rectus abdominis, external oblique abdominis, erector spinae, gluteal muscles, quadriceps and hamstring muscles are activated during this exercise. It has been reported that with the TGU exercise, especially rotator cuff muscle strength, shoulder stability, balance and core stability can be improved.

In the literature, there are many studies examining the effects of stabilization exercises on core muscles. On the other hand, although there are studies reporting that the TGU exercise can improve core stability and shoulder stability, and studies reporting the muscular activation of the shoulder girdle muscles and some trunk muscles during the TGU exercise. To the best of our knowledge, we have not found a study examining its effectiveness on muscle activation, core stability and upper extremity performance and comparing it with any other method.

The aim of this study is to compare the effects of TGU exercise and stabilization exercises on muscular activation, core stability and upper extremity performance in healthy individuals.


Eligibility Criteria:
Inclusion Criteria:

* Healthy, male individuals, between the ages of 18-25, Individuals whose physical activity levels are at least 3000 MET min/week and above according to the International Physical Activity Questionnaire-Short Form, Individuals with a body mass index of 17-30 kg/m2

Exclusion Criteria:

* Professionally engaged in sports, Have any known orthopedic, neurological or cardiovascular problems, Having undergone musculoskeletal surgery in the last 1 year, Individuals who have had a musculoskeletal injury in the last 3 months.
Implementation of a Multidimensional Quality Model

The aim of this study is to measure the experiences about the current care of the patients, their kin and staff by a quickscan based on a multidimensional quality model. Further more we want to define the psychometric characteristics of the quickscan.


Eligibility Criteria:
Inclusion Criteria:

* 18 years old
* Treated/working in the hospital

Exclusion Criteria:

* Do not understand Dutch
Risk Factors for Post-Operative Nonunion of Tibial Shaft Fractures Based on a Path Analysis Model

Tibial shaft fractures is common long tubular fracture that account for about 13.7% of all fractures. And the incidence of nonunion of tibial shaft fracture varied from 1% to 80%. This study aimed to confirm the risk factors of nonunion of tibial shaft fracture. Moreover, the investigators hope to establish the clinical pathway of various risk factors for fracture nonunion and affirm the importance of different risk factors.

Tibial shaft fractures is common long tubular fracture that account for about 13.7% of all fractures. And the incidence of nonunion of tibial shaft fracture varied from 1% to 80%. The investigators retrospectively analyzed the demographics of these participants in our hospital that occur long tubular fracture. One group is participants that existed fracture nonunion. And the other group is the participants that did not exist fracture nonunion. The investigators recorded twelve variables and confirm the risk factors by uni-variate Logistic regression analysis. Moreover, the investigators hope to establish the clinical pathway of various risk factors for fracture nonunion and affirm the importance of different risk factors.

Eligibility Criteria:
Inclusion Criteria:

* The tibial shaft fracture was caused by trauma.

Exclusion Criteria:

* The tibial shaft fracture was caused by tumor, infection and other reasons.
Evaluation of Systolic Function in Heart Failure With Middle Ejection Fraction by 3D Speckle Tracking Imaging

In 2016, the European Heart Association defined the median ejection fraction heart failure for the first time. More research is needed to improve our understanding of this population, so as to make the best clinical decision and improve the prognosis. In this study, 3D-STI was used to evaluate left ventricular systolic function in heart failure with median ejection fraction.

As the final manifestation of cardiovascular disease and the main cause of death, heart failure is one of the important challenges threatening human health in the 21st century. In 2016, the European Heart Association proposed a new classification standard for heart failure. In particular, for the first time, heart failure with median ejection fraction has been clearly defined. These patients have received more and more attention, but there are still relatively few studies on them. More research is needed to improve our understanding of this part of the population in order to make the best clinical decisions and improve the prognosis. 3D speckle tracking technology is a new technology developed on the basis of real-time three-dimensional echocardiography and speckle tracking technology. It is gradually recognized in the evaluation of left ventricular systolic and diastolic function, especially in the evaluation of cardiotoxicity of chemotherapy drugs. At present, the application of 3D-STI in the evaluation of left ventricular systolic function in heart failure with median ejection fraction is limited and needs further study.In this study, 3D-STI was used to evaluate left ventricular systolic function in heart failure with median ejection fraction.

Eligibility Criteria:
Inclusion Criteria:

Meeting the diagnostic and classification criteria of heart failure proposed in the 2016 ESC guidelines for the diagnosis and treatment of acute / chronic heart failure

Exclusion Criteria:

1. acute or chronic infectious diseases;
2. COPD, chronic bronchitis, emphysema and other serious lung diseases;
3. Autoimmune diseases;
4. Malignant tumor;
5. Acute, chronic liver disease or other reasons lead to abnormal liver function (transaminase is more than 3 times of normal value);
6. Acute and chronic kidney disease, end-stage renal disease (serum creatinine \> 220 μmol/L, or creatinine clearance rate \< 30 ml/min);
7. Heart valve disease;
8. Severe arrhythmia;
9. The image quality of echocardiography was poor when it was larger than three sections;
Multispectral Fluorescence as a Tool to Separate Healthy and Disease Related Lymphatic Anatomies in Prostate Cancer.

Multispectral imaging of the lymphatic draining pattern of the tumor and the abdominall wall/lower limb to evaluate technical feasibility to differentiate these patterns and in the future reduce the amount of complications that result from damage to lymphatic structures.

By preventing unnecessary resection of healthy lymphatic tissue during extended lymph node dissections, the investigators will be able to reduce the degree and amount of complications that result from damage to the lymphatic structures. The investigators aim to evaluate the technical feasibility of imaging two different lymphatic drainage profiles, namely that of healthy tissue (i.e. the lower limbs/abdominal wall) and that of the primary tumour (i.e. prostate). To realize the differentiation, real-time multispectral fluorescence imaging of two spectrally different tracers (the lymphangiographic tracer fluorescein (injected in the lower limbs and abdominal wall) and sentinel node (SN) specific tracer Indocyanine Green (ICG)-99mTc-nanocolloid (injected in the tumour, followed by a control lymphoscintigraphy and SPECT/CT)) will allow for multispectral (or multicolor) fluorescence. Complementary to the routine surgical procedure, e.g. radical prostatectomy with extended pelvic lymph node dissection (ePLND), the lymphatic drainage pattern of both the tumour and of healthy tissue, i.e. lower limbs and abdominal wall, will be determined in the surgical field/surgical specimens.

Eligibility Criteria:
Inclusion Criteria Group A:

* Male, aged ≥ 18 years.
* WHO performance status 0,1, or 2.
* Written informed consent.
* Histopathologically confirmed adenocarcinoma of the prostate
* Increased risk of nodal metastases according to the Briganti 2012 nomogram (\> 7%)
* Scheduled for surgical (laparoscopic) prostatectomy including ePLND-
* Suitable for RP and ePLND, as per institutional guidelines

Exclusion Criteria Group A:

* Prior abdominal or inguinal surgery (e.g. appendectomy)
* History of allergy to iodine, food or medicinal induced urticaria, asthma, eczema, or allergic rhinitis
* Hyperthyroid or thyroidal adenoma
* Kidney insufficiency
* History of oversensitivity to FLUORESCITE composites
* Patients using beta-blockers

Inclusion Criteria Group B:

* Male, aged ≥ 18 years.
* WHO performance status 0,1, or 2.
* Written informed consent.
* Histopathologically confirmed adenocarcinoma of the prostate
* Increased risk of nodal metastases according to the Briganti 2012 nomogram (\> 15%)
* Scheduled for surgical (laparoscopic) prostatectomy including ePLND-
* Suitable for RP and ePLND, as per institutional guidelines

Exclusion Criteria Group B:

* Prior abdominal or inguinal surgery (e.g. appendectomy)
* History of allergy to iodine, food or medicinal induced urticaria, asthma, eczema, or allergic rhinitis
* Hyperthyroid or thyroidal adenoma
* Kidney insufficiency