cyrilzakka/clinical-trials huggingface dataset:
Study About Complications of Totally Implanted Venous Access Devices (TIVADs) in People With Cystic Fibrosis (CF)

Pulmonary infections are the major cause of mortality and morbidity in cystic fibrosis (CF); patients frequently have to take antibiotics which often cannot be given orally or by aerosol but have to be administered intravenously. In order to reduce the number of venepunctures, totally implanted venous access devices (TIVAD) or Ports have been used to administer antibiotics and other infusions.

The use of Port systems has been increasing in recent years, especially for those patients requiring frequent intravenous treatments. Having a TIVAD in place makes venous access quicker and also reduces trauma, suffering and pain. However, there are important complications associated with TIVADs which can be early (pneumothorax, arterial puncture, severe bruising) or late (infections, thromboembolic complications and occlusion).

Although the use of TIVADs in CF is increasing, there is little CF-specific literature available on the epidemiology and risk of TIVAD complications. Also, literature is scarce about clinical criteria for deciding to insert a TIVAD. Therefore, so far clinical decisions were based mainly on experiences of TIVAD use in other diseases, such as cancer.

With this prospective observational study we will survey a large population of Italian CF people with TIVAD in order to: collect data about current clinical conditions of CF people with TIVAD; investigate about clinical criteria that led to the decision of positioning a TIVAD; observe the possible onset of late complications.

To be included in the study, subjects need to fulfil the following requirements:

* Diagnosis of CF, made accordingly to the CF Foundation Guideline;
* Ability to consciously express owns informed consent, if aged 18 or more. If minor, presence of at least one legally authorised parent able to consciously express informed consent;
* Have a TIVAD implanted;
* Have no current complications in the TIVAD (infection, thromboembolic complications or occlusion) Outcome Measures

Measured outcomes will be:

1. Incidence of TIVAD infections (Port pocket infection, Cutaneous site infection,Catheter-related infection;
2. Incidence of TIVAD thrombosis;
3. Incidence of TIVAD occlusion.

The observational phase will last 12 months for each subject involved

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of CF, made accordingly to the CF Foundation Guideline
* Ability to consciously express owns informed consent, if aged 18 or more. If minor, presence of at least one legally authorised parent able to consciously express informed consent
* Have a TIVAD implanted
* Have no current complications in the TIVAD (infection, thromboembolic complications or occlusion)
Study of KK3910 in Healthy Volunteers and Patients With Essential Hypertension

Part 1 : To evaluate the safety of single-dose KK3910 in healthy volunteers. Part 2 : To evaluate the safety of multiple-dose KK3910 in patients with essential hypertension.


Eligibility Criteria:
Inclusion Criteria: Part 1

* Voluntary consent to participate in this study must be given (in writing)
* Japanese or non-Asian healthy men 18 to \< 55 years at the time of informed consent ( Japanese healthy men 65 to \< 80 years for the elderly cohort)
* BMI is within the specified range at screening

Inclusion Criteria: Part 2

* Voluntary consent to participate in this study must be given (in writing)
* Japanese patients with essential hypertension, aged 18 to \<65 years at the time of informed consent
* BMI is within the specified range at screening

Exclusion Criteria: Part 1

* History of any respiratory disease, heart disease, gastrointestinal disease, renal disease, liver disease, psychiatric disorder, autoimmune disease, or malignant tumor that may affect assessments in the study, as judged by principal investigator or subinvestigator.
* History of or current drug allergy
* History of or current alcoholism or drug addiction
* Smoking within the specified period
* infection within the specified period
* Any condition judged by the investigator or subinvestigator to be unsuitable for participation in the study

Exclusion Criteria: Part 2

* History of any respiratory disease, heart disease, gastrointestinal disease, renal disease, liver disease, psychiatric disorder, autoimmune disease, or malignant tumor that may affect assessments in the study, as judged by principal investigator or subinvestigator.
* History or of current drug allergy
* History of or current alcoholism or drug addiction
* Pregnant or breastfeeding patients, or patients willing to have a child during the study
* Smoking within the specified period
* infection within the specified period
* Any condition judged by the investigator or subinvestigator to be unsuitable for participation in the study
Heavy Metals' Influence on Early Pregnancy Through Oxidative Stress

Patients with diagnosis of spontaneous abortion are enrolled in the cohort, in the cohort of patients who met the criteria, 3ml of whole blood intravenous and 5ml of urine were taken for heavy metal level examnation. Part of the villi tissue was sent for genetic testing, and the results were traced. In addition, about 10g of villi tissue was frozen for testing. Patients with normal genetic results of villi tissue will have villus samples go through oxidative stress level detection.

From May 1, 2019, patients with diagnosis of spontaneous abortion are enrolled in the cohort, exclusion criteria were: not long-term residents in Peking; Inconvenient for following up; Long-term of drug use; Cesarean section scar pregnancy and other high-risk pregnancy; Diagnosis of pregnancy beyond 12 weeks.

In the cohort of patients who met the criteria, 3ml of whole blood intravenous and 5ml of urine were taken on the day of admission for curettage and suction, and the levels of heavy metals were tested. Part of the villi tissue was sent for genetic testing, and the results were traced. In addition, about 10g of villi tissue was frozen for testing. Patients with normal genetic results of villi tissue will have villus samples go through oxidative stress level detection.

Eligibility Criteria:
Inclusion Criteria:

1) the length of fetal bud is equal to or greater than 7 mm and there is no cardiac activity; 2) the maximum zh diameter of the pregnancy sac is equal to or greater than 25mm, and there is no fetal heart beat; 3) an embryo with no heartbeat at 2 weeks or more after ultrasound examination showing a pregnancy sac without yolk sac; 4) embryos without heartbeat for 11 days or longer after ultrasonography showed the yolk sac as a type pregnancy sac.
Clinical Study of Ingrezza (Valbenazine) for the Treatment of Cervical Dystonia

Study of Ingrezza (Valbenazine) for the treatment of cervical dystonia.

The study will be an open-label, prospective study. Patients with a diagnosis of cervical dystonia will undergo 4 weeks of baseline evaluation, followed by a 12-week treatment period. Subjects will be evaluated in-clinic every 4 weeks. Standardized assessments will be performed at these visits. Data will also be collected from wearable IMUs (inertial measurement units) and analyzed for improvements in involuntary, repetitive movements and postures.

Eligibility Criteria:
Inclusion Criteria:

* Male or female patients between 18 and 85 years of age (inclusive)
* A clinical diagnosis of cervical dystonia (ie, spasmodic torticollis) by investigator for at least six months
* Moderate to severe head tremor and/or dystonic posturing as judged by the investigator
* Stable Botulinum Toxin (Botox, Dysport, Xeomin, or Myobloc) therapy dosage for at least 3 months prior to baseline visit

Exclusion Criteria

* Tardive dyskinesia
* Predominant anterocollis
* Concomitant use of strong CYP3A4 inhibitors (i.e. itraconazole, ketoconazole, clarithromycin), digoxin, strong CYP2D6 inhibitors (i.e. paroxetine, fluoxetine, quinidine), monoamine oxidase inhibitors (i.e. isocarboxazid, phenelzine, selegiline)
* Myotomy or denervation surgery in the affected muscles (eg, peripheral denervation and/or spinal cord stimulation)
* Diagnosis of Myasthenia gravis, Lambert-Eaton syndrome, amyotrophic lateral sclerosis, or any other significant neuromuscular disease which might interfere with the trial
* Moderate to severe hepatic impartment as determined by a Child-Hugh Score ≥7
* Marked limitation on passive range of motion that suggests contractures or other structural abnormality, eg, cervical contractures or cervical spine syndrome
* Any conditions that may increase the risk associated with study participation or may interfere with the interpretation of study results and, in the judgment of the Investigator, would make the patient inappropriate for entry into this study
* Participation in another interventional study during participation in this study
* Pregnant or lactating females, or females of child-bearing potential not willing to use an acceptable method of contraception
* History of hypersensitivity to valbenazine or any components of INGREZZA.
* Is suicidal at screening as defined by below:

  1. According to the C-SSRS, he or she must not be actively suicidal at Visit 1 (Screening) or Visit 2 (Baseline) (including, an answer of "yes" to C-SSRS questions 4 or 5 \[current or over the last 6 months\]) and must not have attempted suicide in the 1 year prior to Visit 1 (Screening); OR
  2. The subject is actively suicidal in the Investigator's judgment
Increasing Knowledge on Osteogenesis Imperfecta by Collecting Epidemiological Data

interventional pilot study with the enrollment of patients affected by Osteogenesis Imperfecta

Subjects diagnosed with Osteogenesis Imperfecta will be undergoing, after collection of informed consent, to a series of assessments using sensor imaging and Gait-Analysis and collection of specific parameters

Eligibility Criteria:
Inclusion Criteria:

* Patients with Osteogenesis Imperfecta (clinical diagnosis) able to perform the gait-analysis movement data acquisition session, in the most complete instrumental configuration, i.e., with kinematics, dynamics and electromyography; it will naturally be evaluated which motor tasks are safely executable and which are not.
* All patients of both sexes will be included
* Patients in the age range: 8-60 will be included

Exclusion Criteria:

* Subjects who do not fit the inclusion criteria
Donafenib Monotherapy for Previously Treated Metastatic Colorectal Cancer

The investigators do the clinical trial (patients with metastatic colorectal cancer treated with donafenib after failure of standard therapy) to assess safety and efficacy of donafenib in patients with metastatic colorectal cancer, progressing after all approved standard therapies.

The study is a multicentre, phase 1B study recruiting 47 patients in 6 sites. Patients were eligible to participate when they have histological or cytological documentation of adenocarcinoma of the colon or rectum. They must have received locally and currently approved standard therapies and to have disease progression during or within 3 months after the last administration of the last standard therapy or to have stopped standard therapy because of unacceptable toxic effects. The available standard therapies have to include as many of the following as were licensed: a fluoropyrimidine,oxaliplatin, irinotecan, and bevacizumab;and cetuximab or panitumumab for patients who had KRAS wild-type tumours.

Patients have to be aged 18 years or older and have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1; life expectancy of at least 3 months;and adequate bone-marrow, liver, and renal function at the start of the trial. Patients could not participate if they had previously received sorafenib or had uncontrolled medical disorders.

All patients receive best supportive care, excluding other investigational antitumour agents or antineoplastic chemotherapy, hormonal therapy, or immunotherapy. Patients receive oral donafenib 300mg (CM4307) of each 4 week cycle until disease progression,death, unacceptable toxic effects, withdrawal of consent by the patient, or decision by the treating physician that discontinuation would be in the patient's best interest.The primary endpoint is safety.The second endpoint is progression-free survival.

Eligibility Criteria:
Inclusion Criteria:

* Have histological or cytological documentation of adenocarcinoma of the colon or rectum;
* Have received locally and currently approved standard therapies and to have disease progression during or within 3 months after the last administration of the last standard therapy or to have stopped standard therapy because of unacceptable toxic effects.
* Standard therapies including as many of the following as were licensed: a fluoropyrimidine,oxaliplatin, irinotecan, and bevacizumab;and cetuximab or panitumumab for patients who had KRAS wild-type tumours;
* Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;
* Life expectancy of at least 3 months;
* Have adequate bone-marrow, liver, and renal function at the start of the trial.
* Prothrombin time international normalized ratio≤2；or prothrombin time≤16 seconds;or activated partial thromboplastin time(APTT) ≤43 seconds;or TT≤21 seconds.

Exclusion Criteria:

* Patients have prior treatment with sorafenib;
* Patients have Central nervous system(CNS) involvement;
* patients have uncontrolled medical disorders.
Sleep-disordered Breathing in Infants With Myelomeningocele

This study aims to determine whether the risk for sleep-disordered breathing in infants with myelomeningocele (a severe form of spina bifida) differs among those who underwent fetal vs. postnatal surgery, and to examine the link between sleep-disordered breathing and neurodevelopment.

Myelomeningocele (MMC), the most severe form of spina bifida, is characterized by exposure of the spinal cord through a spinal defect. Sleep-disordered breathing (SDB) is common in children with MMC and is a risk factor for sudden death. Abnormal sleep physiology is likely multifactorial, related to MMC level, brainstem dysfunction, musculoskeletal factors, and pulmonary abnormalities. In infants, SDB may be treatable with oxygen, caffeine, or positive airway pressure. Yet, SDB screening is not routine, even in centers with specialized MMC programs.

Evaluation of sleep in neonates who require intensive care is an emerging opportunity with potential for major impact on health and quality of life for affected children. As SDB and abnormal sleep are potentially treatable, early assessment and intervention could become an integral part of a multidisciplinary treatment strategy to optimize long-term medical and neurodevelopmental outcomes.

Eligibility Criteria:
Inclusion Criteria: neonates with myelomeningocele who are cared for at a study center NICU are eligible to participate after myelomeningocele repair.

Exclusion Criteria:

* born at \<30 weeks gestation
* congenital anomalies that would predispose to sleep-disordered breathing (e.g. micrognathia)
* confirmed or suspected genetic syndromes that alter developmental outcomes
ICBT for Pain-predominant FGIDs in Children and Adolescents: an Implementation Study.

This open trial aims to evaluate feasibility and preliminary effectiveness of an internet-delivered CBT-program for children and adolescents with functional gastrointestinal disorders when implemented in regular care.

Pain predominant functional gastrointestinal disorders (P-FGIDs) are common in children and adolescents and associated with impaired quality of life. Our research group have previously in a series of efficacy-studies shown that internet-delivered exposure-based CBT leads to reduced symptoms and increased quality of life in children and adolescents with P-FGIDs. There is therefore reason to investigate how the treatment should be disseminated in regular care. This open trial aim to evaluate feasibility and preliminary treatment effects in regular care of the internet-delivered CBT-program for children and adolescents with P-FGIDs.

Method: Open trial with a pretest-posttest-design and no control group. The internet-delivered CBT-program is 10 week long and include weekly therapist support, consisting of online messages and telephone calls. Assessment points are baseline, weekly during treatment, post-treatment and follow-up at 3 months and 6 months after treatment completion.

Analysis: Effect sizes and within-group differences will be calculated in an intent-to-treat analysis using Cohens' d and Student's t-test.

Eligibility Criteria:
Inclusion Criteria:

* Age 8-17 at date of inclusion.
* Fulfilling Rome IV-criteria for irritable bowel syndrome, functional dyspepsia or functional abdominal pain with a written statement from patient's physician confirming a diagnosis.
* Stable psychotropic medication for at least 1 month.

Exclusion Criteria:

* concurrent serious medical conditions.
* a psychiatric diagnosis, judged to be a more important treatment target than the abdominal pain.
* on-going structured psychological treatment.
* absence from school exceeding an average of 2 days a week the last month is a cause for exclusion since high school absence demands more intensive interventions than can be offered in ICBT.
* on-going abuse or severe parental psychiatric illness in the family.
* since treatment format assumes normal reading and writing skills, pronounced language skill deficits and learning difficulties lead to exclusion from the study.
* lack of regular internet-access.
Post Marketing Surveillance Study to Observe Safety and Efficacy of IBRANCE®

This non-interventional study is designated as a Post Marketing Surveillance Study and is a commitment to Ministry of Food and Drug Safety (MFDS).

Before the approval of IBRANCE® in Korea, as a part of Risk Management Plan (RMP), which is required by MFDS, safety and efficacy information of new medication will be provided at minimum 1,000 participants administered in the setting of routine practice during the initial 9 years after the approval.


Eligibility Criteria:
Inclusion Criteria

* Women of ≥18 years of age with proven diagnosis of advanced/metastatic breast cancer (locoregionally recurrent or metastatic disease).
* Estrogen Receptor+ (ER+) and/or Progesterone Receptor+ (PgR+) tumor based on local laboratory results (test as per local practice).
* Human Epidermal Growth Factor Receptor 2 -(HER2-) breast cancer based on local laboratory results (test as per local practice or local guidelines)
* Patients must be appropriate candidates for hormone therapy.
* Evidence of a personally signed and dated informed consent document indicating that the patient (or a legally acceptable representative) has been informed of all pertinent aspects of the study.
* During the post marketing surveillance (PMS) period, patients who initially administer IBRANCE®

Exclusion Criteria

* Known hypersensitivity to letrozole or its excipients or to any Cyclin-Dependent Kinase 4/6 (CDK4/6) inhibitor excipients.
* Pregnant women
Efficacy of Cold-FX (CVT-E002) in the Prevention of Upper Respiratory Tract Infections in Healthy Adults

The purpose of the Study is to determine the prophylactic effects of CVT-E002 treatment for upper respiratory tract infections in healthy adult employees working with residents in continuing care facilities. It is hypothesized that the use of CVT-E002 will effectively reduce the incidence, severity and duration of upper respiratory infections among the participants when compared to placebo.

Eligible continuing care employees will be randomly assigned to either the treatment or placebo group with equal numbers in each group. The treatment will consist of taking two capsules of CVT-E002 (400mg)or placebo every morning, after breakfast, for a period of 12 weeks. The subjects will be given an assessment form to log specific symptoms on a daily basis if they get a cold.

Symptoms include sore throat, runny nose, nasal congestion, hoarseness, cough, earaches, and fever. Subjects will be required to maintain the same dosing even during an upper respiratory infection and will be requested not to take any additional medication for their upper respiratory infection unless prescribed by their family physicians.

Eligibility Criteria:
Inclusion Criteria:

* age 18-64 years
* not pregnant or breast feeding
* good general health

Exclusion Criteria:

* medical conditions: HIV infection; malignancy; cardiovascular disease; hypertension; renal, pulmonary or hepatic abnormalities; neurologic or psychiatric disease; tuberculosis; multiple sclerosis; recent acute respiratory infection (\<2 weeks)
* medications: warfarin; immunosuppressive therapy; corticosteroids; phenalzine; pentobarbital; haloperidol
* major surgical procedure in the previous six months
* history of alcohol/drug abuse
* pregnancy and lactation in women
Evolution of Pulse Pressure Following Initiation of Antihypertensive Therapy in Patients With Essential Arterial Hypertension

The main purpose of this prospective, multicentre, french observational study is to analyse the evolution of pulse pressure (PP) and to identify its prognostic factors in hypertensive patients three months after initiation of a new hypertensive therapy. The PP is defined as the difference between systolic blood pressure (SBP) and diastolic blood pressure (DBP).


Eligibility Criteria:
Inclusion Criteria:

* Patients with essential arterial hypertension needing a new antihypertensive therapy
* A patient was included by the physician only if he/she had agreed after being informed about the study

Exclusion Criteria:
Comparison of IVF and ICSI in Human IVF

In this prospective randomized clinical trial we plan to compare two fertilization method which are widely used during in vitro fertilization (IVF) treatment. Outcome of conventional IVF and intracytoplasmic sperm injection (ICSI) treatment will be compared in this study.


Eligibility Criteria:
Inclusion Criteria:

Infertile patients entering in vitro fertilization treatment At least 1 oocytes collected Semen sample is suitable for IVF and ICSI fertilization as well Number of oocytes collected is lower than 5 AND/OR female age is equal or more than 40 years

Exclusion Criteria:

Samen sample is not suitable for conventional IVF fertilization Previous conventional IVF treatment resulted in \<50% fertilization rate