cyrilzakka/clinical-trials huggingface dataset:
Maximum Tolerable Concentration of abnobaVISCUM Fraxini Intravesically in Patients With Superficial Bladder Cancer

The aim of this phase Ib/IIa study is to investigate the maximum tolerable concentration of abnobaVISCUM® Fraxini for intravesical instillation in patients with superficial bladder cancer. Secondary objectives are the local and systemic tolerability, the influence on tumor remission and the influence on the one-year recurrence rate.

A dose-escalation-study according ICH/GCP (International Conference on Harmonisation/Good Clinical Practice) with different concentrations of abnobaVISCUM® Fraxini is conducted in two hospitals in Germany and Egypt. Patients with superficial bladder cancer TaG1/G2 or T1G1/G2 are enclosed after TUR-B (transurethral resection bladder). The tolerability of the different concentrations is assessed after weekly instillations into the urinary bladder for 6 weeks. A direct antitumoral effect is assessed on a single marker tumor left in the bladder after a complete TUR of all other lesions according a study design established by the EORTC-GENITO-URINARY GROUP (European Organisation for Research and Treatment of Cancer). A re-TUR is conducted after 12 weeks. Tumor response is measured by biopsy of the marker lesion and by cytology. Safety of the instillations is measured by analysis of adverse events, vital signs and clinical laboratory tests. After treatment of a cohort is finished a safety evaluation is conducted to decide about the increase to the next dosage.

Eligibility Criteria:
Inclusion Criteria:

* Patients with clinically proved superficial bladder cancer (Ta G1/G2 or T1G1/G2) 2 - 7 weeks before transurethral resection
* Written informed consent for study participation and for documentation of disease data including further distribution of these data

Exclusion Criteria:

* Muscle invasive bladder carcinoma and/or carcinoma in situ (CIS)
* Intravesical instillation therapy within 6 months prior to study enrolment
* Radiotherapy of the bladder prior to study enrolment
* Contracted bladder (capacity less than 100 ml)
* Non treated acute or chronic urinary tract infection
* Allergy against mistletoe extract preparations
* Subvesical obstructions (e. g. prostate hyperplasia, urethral stenosis, residual urine volume more than 80 ml)
* Severe illnesses and circumstances not permitting study participation (e. g. alcoholism or substance abuse)
* Pregnancy or lactation (pregnancy test if required) as well as women without sufficient contraception
* Participation in another clinical study within 30 days prior to this study
* Administration of immunotherapeutic and/or cytostatic drugs within 4 weeks prior to study enrolment
* Chronic progressive infections (e. g. tuberculosis)
* Pre-treatment with mistletoe extracts/mistletoe lectins
Clinical Trial in Females for Female Pattern Hair Loss

This is a six month clinical trial to evaluate the effectiveness and safety in women with Female Pattern Hair Loss (FPHL), comparing a 5% minoxidil topical foam (MTF) formulation applied once a day versus a topical foam vehicle (placebo) formulation applied once a day.

This is a phase 3, two-arm, randomized, double-blind, vehicle-controlled, multi-center, 24-week, parallel design trial to evaluate the efficacy and safety in women with Female Pattern Hair Loss (FPHL), comparing the 5% MTF formulation versus the foam vehicle formulation.

This clinical trial is designed to compare the risk/benefit profile of the new 5% MTF formulation applied once a day (OD) versus the foam vehicle formulation applied once a day (OD), using objective efficacy measures and safety assessments.

Study centers will screen a sufficient number of participants so that a minimum of 300 female participants with FPHL will be enrolled, to ensure 260 complete. There will be at least 16 participants enrolled per center at multiple centers located across the US and globally. Approximately 300 participants will be randomly assigned in a 1:1 ratio to use either 5% MTF OD or foam vehicle OD, for 24 weeks for efficacy and safety evaluations.

Participants meeting the inclusion criteria will be randomly assigned in the order of their enrollment at each site. The signing of the informed consent and assignment of a participant number to a subject shall constitute enrollment.

During the trial following enrollment at Baseline, participants will return to the study site at Weeks 1, 6, 12, 18 and 24 for safety assessments, adverse events monitoring, and compliance assessments. At the Week 12 and 24 visits, efficacy assessments will also be conducted, using Target Area Hair Counts (TAHC), measured by macrophotography.

Eligibility Criteria:
Inclusion Criteria:

* females, age 18 or older in general good health
* exhibits female pattern hair loss
* signs and dates an informed consent document
* agrees to use an adequate method of birth control; if of childbearing potential
* shows a negative urine pregnancy test at Screening Visit
* is willing to maintain the same hair style, hair color, and hair regimen throughout the study
* is willing and able to comply with scheduled visits, treatment plan, laboratory tests and other trial procedures

Exclusion Criteria:

* hypersensitivity to the (study product), or any ingredients of the (study product)
* known allergy to hair dye, or hair dye components
* clinically relevant history of hypotension
* untreated or uncontrolled hypertension
* pregnant, planning a pregnancy or nursing a child
* history of hair transplants
* currently use hair weaves or non-breathable wigs
* dermatologic disorders of the scalp that require chronic use of medication for control
* other types or history of hair loss
* enrolled in any other investigational medication (drug) study currently, or within the last 6 months
Ultrasonographic Evaluation of Diaphragm and Quadriceps in Chronic Obstructive Pulmonary Disease (COPD) Patients

The purpose of this study is to evaluate the prognostic role of echographic diaphragmatic assessment and vastus lateralis muscle ultrasound (US) in two independent populations of patients hospitalized for exacerbated Chronic Obstructive Pulmonary Disease (COPD) or undergoing pulmonary rehabilitation.

Specific aims of this protocol are: 1) to analyze the correlation between qualitative and quantitative US parameters and severity of illness indicators and respiratory function data; 2) to detect the postrehabilitation outcomes in terms of diaphragmatic and vastus lateralis muscle function, assessed by US, and the correlation between these outcomes and indicators of pulmonary rehabilitation treatment effectiveness; 3) to evaluate the ability of qualitative and quantitative US parameters to predict in-hospital mortality and length of stay; 4) to evaluate the ability of qualitative and quantitative US parameters to predict exacerbation rate, hospitalization rate and mortality rate six months after the discharge.


Eligibility Criteria:
Inclusion Criteria (Group A):

* COPD diagnosis
* previous or actual cigarette smoking history
* COPD exacerbation requiring hospitalization
* Obtained written informed consent

Exclusion Criteria:

* Pleural effusion extended for more than two intercostal spaces
* Interstitial lung diseases
* Major surgery in the previous 30 days
* Right pleurodesis or fibrothorax
* Right stroke outcomes
* Technical impossibility to perform ultrasound evaluations
* conditions, clinical or otherwise, that in the investigator's judgment may interfere with the study, or not recommending participation for security reasons
* Absence of written informed consent

Inclusion Criteria (Group B):

* COPD diagnosis
* previous or actual cigarette smoking history
* COPD exacerbation requiring hospitalization in the previous 30 days
* Indication to undergo a pulmonary rehabilitation protocol
* Obtained written informed consent

Exclusion Criteria:

* Pleural effusion extended for more than two intercostal spaces
* Interstitial lung diseases
* Major surgery in the previous 30 days
* Right pleurodesis or fibrothorax
* Right stroke outcomes
* Technical impossibility to perform ultrasound evaluations
* conditions, clinical or otherwise, that in the investigator's judgment may interfere with the study, or not recommending participation for security reasons
* Absence of written informed consent
Pharmacokinetic Interactions Between Amlodipine Besylate/Valsartan and Atorvastatin in Healthy Male Subjects

The purpose of the study is to assess the pharmacokinetic interactions between amlodipine besylate/valsartan and atorvastatin single or co-administered in healthy volunteers.


Eligibility Criteria:
Inclusion Criteria:

1. Male volunteers in the age between 20 and 45 years old
2. The weight is over 55kg and is not exceed ±20% of ideal weight Ideal weight = \[height -100\]\*0.9
3. Subjects with no history of any significant chronic disease
4. Judged to be in good health on the basis of routine laboratory data obtained prior to study drug administration
5. Willing to adhere to protocol requirements and sign a informed consent form

Exclusion Criteria:

1. Subjects with Symptoms of acute disease within 28days prior to study medication dosing
2. Subjects with a history of gastrointestinal diseases which might significantly change ADME of medicines
3. Subjects with a history of clinically significant allergies including drug allergies or anaphylaxis to amlodipine, valsartan and/or atorvastatin
4. Subjects with a history of myopathy
5. Subjects with a hereditary problems, for example, galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption
6. Subject with the mean blood pressure of siDBP ≥ 150 mmHg or ≤ 90 mmHg and/or siSBP ≥ 95 mmHg or ≤ 50 mmHg at the screening visit
7. Subjects with abnormal HDL-cholesterol(\<35mg/dL)
8. Subjects with abnormal of serum potassium concentration (\<3.4 mEq/L of \>5.5 mEq/L in screening visit)
9. Subjects with a history of drug abuse
10. Subjects taking inducer or inhibitor of drug metabolism enzyme such as barbital within 28days prior to study medication dosing
11. Subjects who have received any drugs that might confound the results of the trial based on medical judgement by investigators within 14days prior to drug administration and OTC or vitamin within 7days prior to drug administration
12. Participated in a previous clinical trial within 60 days prior to dosing
13. Donated blood within 60 days prior to dosing
14. Subjects with a history of alcohol abuse(over 21 units/week, 1 unit = 10 g of pure alcohol) or is difficult to stop drinking within study
15. Subjects have ever smoked over 10 cigarette per day within 3 months prior to drug administration
16. Subjects with a history of caffeine abuse or or is difficult to stop drinking within study
17. Subjects with biliary obstruction
18. Subjects with hepatic dysfunction (AST or ALT \>3 times to accepted normal range)
19. Subjects with moderate renal dysfunction (creatinine clearance (CLcr) \< 30mL/min)
20. Subjects considered as unsuitable based on medical judgement by investigators
The Expression and Significance of MiRNA

It is not always known what causes PAH or what the best treatment is. The doctors doing this study would like to understand more about why some people develop PAH and other do not. They also would like to learn more about which treatments might help PAH and which people might respond better to treatments.

Doctors think that testing certain substances found in blood cells might help answer these questions. These substances are normally released by our bodies to protect us from infection and to tell the difference between normal and foreign substances in our body. Finally, a new test will study very small molecules called microRNA that control how our genes are expressed. This study is being done to see if blood samples can be tested to determine who might develop PAH, how well drugs will work to treat PAH and to learn more about the development of PAH.

You will be asked to donate blood when you have your right heart catheterization and also at the 3-4 month follow-up visit. The amount of blood collected during your heart catheterization is about 20cc (about 4 teaspoons). This blood is discarded as part of the clinical catheterization procedure, but we are asking that we use it for this research study. Then, at the follow-up right heart catheterization, you will be asked to donate 20 cc (which is about 4 teaspoons) of blood.

If the second right heart is not required for clinical purposes then you will be asked to give a blood sample during your 3-4 month follow up clinic visit.

If you require an additional right heart catheterization, within one year, we will ask that you donate additional samples at the subsequent RHC.

Other data collected as part of your clinical care, such as medical history, chest x-ray (picture of your lungs), echocardiogram (picture of your heart), ventilation perfusion scan (determines how much blood goes to your lungs), chest CT (thin pictures of my lungs as slices), pulmonary function tests (breathing tests), and lab blood tests, will be used as part of this research.

Eligibility Criteria:
Inclusion Criteria:

* ≥ 18 years of age
* Not pregnant
* Undergoing right heart catheterization for PAH diagnosis

Exclusion Criteria:

* Pregnant
An Effectiveness, Safety, and Palatability Study of Pancrelipase Microtablets in Infants and Toddlers With Cystic Fibrosis and Fat Malabsorption

The purpose of this study is to evaluate the effectiveness and safety of PANCREASE MT (pancrelipase microtablets) to improve steatorrhea (excessive excretion of fat in feces) in infants and toddlers with cystic fibrosis who have pancreatic insufficiency, and to assess whether the consistency of the microtablets is acceptable for swallowing in infants and toddlers

The objective of this randomized, Investigator-blinded, parallel group, multicenter, pilot study is to evaluate the preliminary safety, palatability and effectiveness of pancrelipase microtablets to improve fat absorption. The hypothesis is that PANCREASE MT will provide effective, safe and palatable pancreatic enzyme supplementation to be used for the treatment of fat malabsorption in a cohort of infants with cystic fibrosis-related pancreatic insufficiency. On Day 1 of the study, parents will be instructed to administer 500 units lipase/kg/meal for a full five days. Stool will be collected and analyzed during the last 72 hours of this baseline period. On Day 6 of the study, subjects will be randomly assigned to one of four treatment groups. Parents will be instructed to administer the appropriate dose for a full five days and stool will be collected and analyzed during the last 72 hours of this randomized treatment period. Patients will receive PANCREASE MT 500 units lipase/kg/meal by mouth for a maximum of five doses per day for the first 120 hours. Patients will receive PANCREASE MT 500, 1000, 1500 or 2000 units lipase/kg/meal by mouth, for a maximum of five meals per day for the next 120 hours.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of cystic fibrosis
* Excessive discharge of fat in feces
* Stable patient requiring pancreatic enzyme therapy

Exclusion Criteria:

* No stable antibiotic therapy for small bowel overgrowth
* No hypersensitivity to pork products
* No use of prokinetics eg, metoclopramide or cisapride within the last 30 days
* No nasogastric feeding tube feeding
* No use of steroids
* No use of concomitant H2 blockers or proton pump inhibitors as concomitant therapy
Diagnosis and Intervention of Complicated Twin Diseases

Fetal medicine in China is still a new, young discipline, and the development is very rapid. After nearly 10 years of development, the clinical diagnosis and treatment guidelines of some complicated twin diseases has been established , but they are still needed to be improved. Through this study, the investigators expect to achieve better prediction indicators and early intrauterine precise diagnosis of complicated twin diseases. Also, better procedures of implementing effective intrauterine intervention and assessing the safety and effectiveness of intrauterine intervention are anticipated to be established.

A better guideline for complicated twin diseases are anticipated to be established in China. Molecular genetics and imaging technology are applied to evaluate the outcome and prognosis of intrauterine intervention for complex twin diseases. 3D printing technology is used to assist the preoperative evaluation of fetal intrauterine intervention. Better fetal intrauterine intervention technique and prognosis evaluation are expected to be established.

Eligibility Criteria:
Inclusion Criteria:

* Pregnancy women with complicated twin diseases who are able to withstand intrauterine treatment and consent informed.

Exclusion Criteria:

* Pregnancy women who refuse intrauterine treatment.
Vision II: Evaluation of GALILEO Intravascular Radiotherapy System

To assess the safety and effectiveness of intravascular brachytherapy for the treatment of intrastent restenosis of coronary lesions with the Galileo system

The purpose of this study is to evaluate the cardiac events (MACE) and adverse extra cardiac events at 6 month follow up and up to 24 months for the patients treated with Galileo system

Eligibility Criteria:
Inclusion Criteria:

* Patient with angor, patients with only one de novo lesion. Target zone must be \< 52 mm, artery section must be \< 3,7mm and \> 2,25 mm

Exclusion Criteria:

* Vessel with extremely tortuous proximal segment, lesion with angulous segments (\>90°) Unstable ventricular arrhythmia, dialysis, MI within the last 72 hours etc...
Implementation and Outcome of Minimally Invasive Pancreatoduodenectomy in Europe:

A planned analysis of outcomes among consecutive patients after MIPD from centers participating in the E-MIPS registry (2019-2021). Main outcomes of interest were major morbidity (Clavien-Dindo grade ≥3) and 30-day/in-hospital mortality.

The European registry for Minimally Invasive Pancreatic Surgery (E-MIPS) is an E-AHPBA endorsed registry with the aim to monitor and safeguard the introduction of MIPD in Europe. International multicenter audit-based studies focusing on outcomes of minimally invasive pancreatoduodenectomy (MIPD) are lacking.

A planned analysis of outcomes among consecutive patients after MIPD from centers participating in the E-MIPS registry (2019-2021). Main outcomes of interest were major morbidity (Clavien-Dindo grade ≥3) and 30-day/in-hospital mortality.

Eligibility Criteria:
Inclusion Criteria:

- Data from all patients who underwent R-MIPD and L-MIPD between January 1st 2019 and December 31st 2021 were included

Exclusion Criteria:

* Other pancreatic procedures
* Hybrid approaches (reconstruction phase open)
* Procedures with insufficient baseline data / missing primary outcome data.
Lifestyle Medicine for Enhancing Psychological Wellness in Police Officers

This study will examine the feasibility and efficacy of lifestyle medicine for the enhancement of psychological wellness in police officers. The integrative lifestyle intervention is based on the "Healthy Body Healthy Mind (HBHM)" programme developed by the University of Melbourne. It includes lifestyle psychoeducation, physical activity, nutrition and diet, relaxation/ mindfulness, and sleep. These components are weaved with psychological elements such as stress management, cognitive restructuring, motivational interviewing, and goal setting strategies that are led by clinical psychologists. While lifestyle medicine has been recognised for centuries a a mean to improve physical health, the field of lifestyle medicine in the context of mental health is still in its infancy. Nevertheless, there is increasing evidence demonstrating the efficacy of individual components of lifestyle medicine (e.g. diet, physical activities, and sleep) on mood and stress management. With a well-researched lifestyle medicine programme adopted from Australia, the research team of the Chinese University of Hong Kong has customised the intervention protocol to fit the Chinese culture, and has conducted a pilot trial to test the protocol across different communities and work populations. The investigators aim to examine the effectiveness of an integration of multiple lifestyle adjustments on psychological wellness from a holistic body-mind perspective. Acknowledging that police officers are one of hte work populations with stressful work nature, it is in a hope that lifestyle medicine would be effective to facilitate stress coping and enhance the psychological wellness of police officers in the long run.


Eligibility Criteria:
Inclusion Criteria:

1. Hong Kong residents aged ≥ 18 years;
2. Cantonese language fluency;
3. Patient Health Questionnaire (PHQ-9) score ≥ 10; and
4. Willingness to provide informed consent and comply with the trial protocol.

Exclusion Criteria:

1. Pregnancy;
2. Have suicidal ideation with PHQ-9 item 9 score ≥ 2 (referral information to professional services will be provided to those who endorsed items on suicidal ideation);
3. Using medication or psychotherapy for depression;
4. Having unsafe conditions and are not recommended for exercising or a change in diet by physicians; and
5. Have major psychiatric, medical or neurocognitive disorders that make participation infeasible or interfere with the adherence to the lifestyle intervention.
Prevalence of Rest Dyspnea and Impact of Non Invasive Ventilation on Breathing Sensations in CCHS Patients

Congenital central hypoventilation syndrome (CCHS) is a neuro-respiratory disease characterized by lifethreatening sleep-related hypoventilation involving an alteration of CO2/H+ chemosensitivity. This suggests cortical activity during awakening to maintain breathing. Cortical activity to keep breathing is usually associated with breathing discomfort ; this is the case in healthy subjects under non invasive ventilation (NIV) or with expiratory charge as well as in patients with amyotrophic lateral sclerosis. This can suggest that CCHS may be breathless at rest and this discomfort could be reduced by NIV.

The objective is to evaluate dyspnea with a multi dimensional score, MDP, in CCHS patient at rest in every day life and during 1H session of NIV.

The investigators will perform a prospective, including 20 CCHS patients. MDP scores will be measure before and after 1H-non invasive ventilation as well as a visual scale of 100mm in order to evaluate variation of breathing discomfort before/after NIV.

The investigators expect that CCHS patients don't have rest dyspnea but NIV would improve breathing discomfort that would mean they have latent rest dyspnea.


Eligibility Criteria:
Inclusion Criteria:

* patients with CCHS confirmed by genetic test
* patients with long term non invasive ventilation
* no recent condition that could impact breathing sensations such as infection, pulmonary embolism, heart failure

Exclusion Criteria:

* pregnancy
* phrenic nerve stimulation