cyrilzakka/clinical-trials huggingface dataset:
Balloon Aortic Valvuloplasty Performed Without Heparin to Decrease Vascular and Bleeding Complications of the Procedure

To assess if the non use of heparin sodium during balloon aortic valvuloplasty reduces serious complications due to the procedure, by decreasing the rate of vascular and hemorrhagic complications without increasing the rate of ischeamic events.


Eligibility Criteria:
Inclusion Criteria:

* be over 18
* carry a tight and symptomatic aortic stenosis
* have an indication for a ballon aortic valvuloplasty
* Subject have signed his written informed consent

Exclusion Criteria:

* Have an absence of femoral surgical approach
* have a criticial hemodynamic state, considered as outdrove for the treatment
* have a severe aortic failure
* allergia to heparin
* contraindication to heparin or/and local anaesthetic
* be treted by low molecular weight heparin in less than 12 hoursbefore the intervention or by standard heparin in less than 4 hours before the valvulopasty
* have a tight but not symptomatic aortic stenosis
Explorative Study of AZD1305 in Atrial Fibrillation Patients

Explorative study in Atrial Fibrillation patients to assess Safety and Pharmacokinetics at initiation of treatment and at steady state


Eligibility Criteria:
Inclusion Criteria:

* Documented Atrial Fibrillation but in stable SR for at least 2 h and a maximum of 28 days.
* Sinus rhythm at randomisation

Exclusion Criteria:

* Haemodynamically unstable condition as judged by the Investigator, systolic BP \<100 mmHg or \>180 mmHg, or diastolic BP \>105 mmHg at randomisation
* Personal or family history of Torsades de Pointes (TdP), any other polymorphic ventricular tachycardia (PVT), sustained ventricular tachycardia, long QT syndrome and/or Brugada syndrome
* Sinus bradycardia (\<50 beats per minute (bpm)) at randomisation
* QTc (Fridericia, QTcF ) \>450 ms measured in sinus rhythm at randomisation,
* Serum potassium below 3.8 or above 5.0 mmol/L or plasma potassium below 3.6 or above 5.0 mmol/L
* QRS duration \>120 ms at randomisation
* Use of any antiarrhythmic drug class I and/or III, digitalis glycoside, QT prolonging drug and/or drug that inhibits CYP3A4, as well as St John's Worth
Effects of Soluble Fiber on Blood Pressure: A Meta-analysis of Randomly-controlled Trials

The present study conducted a meta-analysis of 22 randomly controlled trials to assess the effects of soluble fiber intake on blood pressure in human subjects.

Using the Cochrane Handbook for Systematic Reviews of Intervention, a systematic review and meta-analysis was conducted. Information regarding study methods, characteristics, mean BP and standard deviations were extracted The data from each study were pooled using a random effects model to estimate the effects of soluble fiber consumption on blood pressure.


Eligibility Criteria:
Inclusion Criteria:

* Randomized Controlled Trials
* Parallel or Crossover Design
* Duration: \>3 weeks
* Human trials
* Viscous (soluble) fiber
* Viable endpoint data
* Articles published in English

Exclusion Criteria:

* Non-human
* Non-randomized
* Lack of control
* Less than 4 weeks in duration
* No viable endpoint data
Use of Dehydroepiandrosterone (DHEA) in Women With Normal and Poor Ovarian Reserve Undergoing IVF

The aim of the study is to evaluate the effect of DHEA supplement on ovarian reserve markers, ovarian response to gonadotrophins and cycle outcomes in patients with normal and poor ovarian reserve.

Study Hypotheses:

1. DHEA supplementation would improve markers of ovarian reserve and ovarian response to low dose FSH stimulation in both normal and poor responders
2. DHEA supplementation would improve IVF cycle outcomes

Consecutive patients attending subfertility clinic at the Department of Obstetrics and Gynaecology, Queen Mary Hospital who are scheduled for in-vitro fertilization (IVF) treatment will be recruited and written consent will be obtained.

Baseline assessment will be performed at early follicular phase (Day 2 or 3) with hormonal tests and ultrasound.

Subjects will be divided into two groups, the normal ovarian reserve group and the poor ovarian reserve group according to AFC. Poor ovarian reserve is defined as an AFC of less than 5, while normal ovarian reserve is defined as an AFC of 5 to 15 based on a previous study showing AFC being a good predictor of ovarian response (Tomas 1997). Subjects with normal ovarian reserve will be further subdivided into \<35 and \>/=35 years old while subjects with poor ovarian reserve will be further subdivided into first or subsequent cycles of IVF for subgroup analysis.

Subjects in both the normal and poor ovarian reserve group will be randomized according to a computer-generated randomization list in sealed envelopes to receive either DHEA at 25mg three times a day or placebo throughout the study period.

Any changes in hormonal profile and ovarian reserve will be assessed by the above-mentioned blood tests and pelvic ultrasound scans which will be repeated at early follicle phase (Day 2 or 3) in the two subsequent cycles.

After two months of DHEA/placebo treatment, the subjects will then be given a standard low dose ovarian stimulation with 75 IU intramuscular human menopausal gonadotrophin (HMG, Menogon®, Ferring Pharmaceuticals) daily for 7 days. Blood tests and pelvic ultrasound scan will be repeated after 7 days of stimulation (ie. on day 10 or 11).

Hormonal profile and ovarian reserve will be repeated in follicular phase (D2 or 3) in the subsequent cycle, where all patients will then be offered a cycle of IVF treatment using antagonist protocol based on our standard departmental regimen. Cycle characteristic and pregnancy outcomes will be compared.

Analysis of ovarian reserve markers, ovarian response and IVF outcomes would be performed.

Eligibility Criteria:
Inclusion Criteria:

* Indicated for IVF treatment according to our standard department protocol
* Age \< 40
* Regular menstrual cycles (21-35 days with \</= 4 days inter-cycle variation)
* AFC not more than 15

Exclusion Criteria:

* Previous chemotherapy or pelvic irradiation
* Polycystic ovarian syndrome or polycystic ovaries
* On hormonal supplementation for any indication at the time of recruitment (e.g. estrogen, testosterone or DHEA)
Aribulin Combined With Carboplatin and Bevacizumab in the Treatment of Ovarian Cancer

This is a prospective phase II, single-center, single-arm clinical study of platinum-sensitive relapsed ovarian cancer. The main objective of this study is to evaluate the efficacy, safety and tolerability of Aribrine combined with carboplatin and bevacizumab in first-line treatment of platinum-sensitive relapsed ovarian cancer.

This is a phase II prospective, single-center, single-arm clinical study for platinum-sensitive recurrent ovarian cancer. The main objective of this study is to evaluate the efficacy, safety and tolerability of alibulin combined with carboplatin and bevacizumab in first-line treatment of platinum-sensitive recurrent ovarian cancer.

Trial time plan: The inclusion time of the plan: 22 months. Planned trial duration: 24 months.

1. Experimental drugs: Aribrine mesylate injection, carboplatin, bevacizumab.
2. Administration regimen: Iribrine mesylate injection: 1.4mg/m2i.v. 30 min, d1 d8, every 21 days; Carboplatin: AUC=5\~6 i.v. d1, every 21 days; Bevacizumab: 7.5mg/kg, i.v. 30-90 min,d1, every 21 days. The dose can be adjusted according to the state of the patient.

Eligibility Criteria:
Inclusion Criteria:

* Patients with measurable or immeasurable disease (RECIST v1.1) or CA 125 evaluable disease (GCIG criteria) or histologically confirmed diagnosis of recurrent ovarian cancer.
* First disease recurrence after first-line platinum chemotherapy \>6 months.
* 18 years of age ≤75 years of female.
* Expected survival ≥ 3 months.

Exclusion Criteria:

* Partial tumor related symptoms.
* Partial comorbidity.
* Subjects developed new secondary malignancies.
* other.
Translation and Validation of the Upper and Lower Limbs, Pain, Autonomy and Quality of Life Scales in Albanian

The cross-cultural adaptation will be performed according to the internationally recommended methodology, using the following guidelines: translation, back-translation; revision by a committee, questionnaire diffusion and data collection and analyzing.

The psychometric properties will be evaluated by administering the questionnaire to approximately 300 participants. Reliability will be estimated through stability and homogeneity assessment

The assessment scales of the upper and lower limbs, pain, autonomy and quality of life for use in the Albanian-speaking population are as follow:

1. Adaptation, validation and test-retest reliability of upper limbs scales as: Disabilities of the arm, shoulder and hand questionnaire (DASH), MAYO Elbow score, oxford Elbow score, patent-rated tennis elbow evaluation, shoulder pain and disability index (SPADI), Simple Shoulder Test (SST) and Upper Limp Functional Index (ULFI).
2. Adaptation, validation and test-retest reliability of lower limb scales as: Oxford Hip Score, Motricity Index and Trunk Control Test in Albanian language.
3. Adaptation, validation and test-retest reliability of health scales and autonomy: Berg Balance scale, Functional Ambulation Category (FAC), Fear-Avoidance Beliefs Questionnaire (FABQ), Graded Chronic Pain Scale (GCPS),Motor Assessment Scale (MAS), Stroke rehabilitation Assessment of movement (STREAM), Hospital Anxiety and Depression Scale (HADS), Headache Impact Test (HIT6), Leeds Assessment of Neuropathic Symptoms and Signs pain scale (LANSS), Instrumental activities of daily living scale (IADL), Neck Disability Index (NDI), health status questionnaire (EQ-5D-5L), Social Responsiveness Scale (SRS), short portable mental status questionnaire (SPMSQ), Tampa Skale Kinesiophobia, Ankle--Hindfoot Scale (AOFAS) and the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC).

Eligibility Criteria:
Inclusion Criteria:

* articular and muscular pain
* back pain
* presence of rheumatologic symptoms
* functional misbalance
* scoliosis
* musculoskeletal disorders

Exclusion Criteria:

* no native albanian language
* severe trauma to the lumbar spine or hip(s)
* tumor
* metabolic disease
Changes in Renal Function and Body Composition in Pulmonary Hypertension

Changes in renal function and body composition in patients with pulmonary hypertension

This prospective single-center study is designed to analyze changes in renal function and body composition in patients with suspected or pre-diagnosed pulmonary hypertension at pulmonary hypertension outpatient clinic, University Hospital Giessen and Marburg, Campus Giessen.

Eligibility Criteria:
Inclusion Criteria:

* Subjects older than 18 years at pulmonary hypertension outpatient clinic
* Subjects who signed informed consent forms

Exclusion Criteria:

* Patients refusing to participate or withdraw consent during follow-up
Combined Effects of Global Posture Re-education and Active Cycle of Breathing Technique in COPD

The randomized controlled trial will involve 30 participants, with Group A receiving GPRM and ACBT, while Group B follows the conventional COPD model that includes ACBT only.Assessments of heart rate, physical fitness, and quality of life will contribute to a nuanced understanding of joint function, informing future COPD treatment paradigms.

The focus of this study will be on addressing the critical challenge of treating chronic obstructive pulmonary disease (COPD), a globally prevalent and heterogeneous lung condition associated with substantial morbidity and mortality. With COPD anticipated to become the leading global cause of death, this research will investigate a novel intervention that combines global postural retraining (GPRM) and physical fitness, utilizing respiratory cycle technology (ACBT). This study assumes to enhance heart rate, posture, and overall quality of life in individuals with COPD. The randomized controlled trial will involve 30 participants, with Group A receiving GPRM and ACBT, while Group B follows the conventional COPD model that includes ACBT only. The study, utilizing nonprobability purposive sampling, will span six months to comprehensively evaluate cardiovascular, respiratory, and quality-of-life outcomes. Exclusion criteria ensure a representative sample, excluding individuals with severe diseases or recent surgeries. The significance of this investigation lies in its potential to revolutionize COPD treatment, offering a cost-effective approach that simultaneously enhances patient health. By targeting both biomechanical and respiratory aspects, the study aims to provide valuable insights into improving COPD treatment strategies globally, with a focus on the combined effects of global postural retraining and active breathing techniques. Assessments of heart rate, physical fitness, and quality of life will contribute to a nuanced understanding of joint function, informing future COPD treatment paradigms.

Eligibility Criteria:
Inclusion Criteria:

1. Adults aged 40-75 years diagnosed with stable COPD (according to GOLD guidelines).
2. Patients of both genders
3. FEV1: FVC ranging from 68 - 69%.
4. Predicted FEV1 of less than 70%.
5. Willingness to participate

Exclusion Criteria:

1. Acute Exacerbation of COPD
2. Participants with severe comorbidities, such as unstable cardiovascular diseases (e.g., recent myocardial infarction, uncontrolled hypertension)
3. Participants diagnosed with respiratory conditions other than COPD (such as asthma, interstitial lung disease)
4. Individuals who have undergone major thoracic or abdominal surgery within the past three months
5. Individuals with severe mental health conditions (such as uncontrolled psychosis or severe depression)
6. Pregnant or lactating individuals.
Effectiveness of an Interdisciplinary, Nurse-coordinated Atrial Fibrillation Expert Program for Primary Care Patients

The purpose of this study is to assess the effectiveness of a newly developed interdisciplinary nurse-coordinated AF expert program for primary care patients. Therefore a prospective, pragmatic clustered randomized controlled trial will be performed in general practices.


Eligibility Criteria:
Inclusion Criteria:

* Every newly diagnosed AF patient.
* Every AF patient who is not seen by a cardiologist or electrophysiologist in the past 2 years before inclusion.
* AF must be confirmed on electrocardiogram.
* Capable of providing written informed consent.
* Dutch speaking and verbally testable, without cognitive impairment.

Exclusion Criteria:

* AF patients who once received an arrhythmologic consult about AF prior to the start of the study.
* AF patients who have a systematic follow-up at a cardiologist prior to the start of the study.
* Terminally ill AF patients
* Participation in another clinical trial
Management of Recurrent Implantation Failure

This is the first study to investigate, whether pregnancy and implantation rates would improve in patients with recurrent implantation failure (RIF), if all embryos were to be frozen and transferred in a consecutive natural cycle.

There is growing evidence that elective frozen-thawed embryo transfer in a non-stimulated cycle (freeze-all policy) would eliminate the risk of controlled ovarian stimulation and resulting in better endometrial receptivity and lower uterine contractility as compared with fresh intracytoplasmic sperm injection (ICSI) cycles.

RIF refers to women who fail to achieve a clinical pregnancy, in a minimum of three embryo transfer cycles with at least four good-quality embryos were transferred in a woman \< 40 years. It affects approximately 10% of ICSI cases. Many management protocols aimed to enhance ICSI outcome in cases of RIF, however, none of them examined the effect of freeze all policy in this category of patients.

Eligibility Criteria:
Inclusion Criteria:

1. gonadotropin-releasing hormone agonist and recombinant follicle-stimulating hormone (FSH) in a long protocol cycles;
2. female partners were under age of 40 years;
3. all the patients had a history of recurrent implantation failure i.e: failed to achieve a clinical pregnancy after at least three fresh ICSI cycles where at least 8 good embryos were transferred;
4. their embryos were pushed to Day 5 resulting in blastocysts, and undergo embryo transfer day 5 or vitrification on day 5;
5. endometrial thickness ≥ 7 mm;
6. selected embryos for embryo transfer were blastocysts. -

Exclusion Criteria:

Couples with testicular or epididymal sperm were excluded.

-
Imetelstat in Combination With Paclitaxel (With or Without Bevacizumab) in Patients With Locally Recurrent or Metastatic Breast Cancer

The purpose of this study is to evaluate the efficacy and safety of treatment with imetelstat + paclitaxel (with or without bevacizumab) versus paclitaxel (with or without bevacizumab) alone for patients with locally recurrent or metastatic breast cancer who have not received chemotherapy or have received one non-taxane based chemotherapy for metastatic breast cancer.

Patients will be randomized in a 1:1 ratio to imetelstat + paclitaxel (with or without bevacizumab) versus paclitaxel (with or without bevacizumab) alone.

Eligibility Criteria:
Inclusion Criteria

* Histologically or cytologically confirmed adenocarcinoma of the breast that is either locally recurrent or metastatic. Locally recurrent disease must not be amenable to surgical resection or radiation with curative intent
* Either have not received chemotherapy or may have had one prior non-taxane chemotherapy regimen for metastatic disease (there are no restrictions on prior hormonal therapy)
* Prior use of bevacizumab is allowed provided that it was not administered in combination with a taxane
* ECOG performance status 0-1
* Adequate bone marrow reserve as indicated by:

  * ANC \> 1500/uL (without use of growth factors within 7 days)
  * Platelet count \> 100,000 (without transfusion in prior 7 days)
  * Hemoglobin \> 9.0 g/dL

Exclusion Criteria:

* Women who are pregnant or breast feeding
* Locally recurrent disease amenable to resection with curative intent
* HER-2-positive breast cancer
* Active central nervous system (CNS) metastatic disease including those patients receiving radiotherapy and/or steroid treatment (within the last 3 months)
* Prior adjuvant or neoadjuvant taxane chemotherapy within 12 months prior of first relapse
* Investigational therapy within 4 weeks of first study drug administration
* Prior radiation, cytotoxic, or hormonal therapy within 2 weeks of first study drug administration
* Therapeutic anti-coagulation or regular use of anti-platelet therapy within 2 weeks prior to first study drug administration (low dose anti-coagulant therapy to maintain patency of a vascular access device is allowed)
* Grade ≥ 2 neuropathy
* Uncontrolled clinically significant atrial or ventricular arrhythmias (unless pacemaker in place)
* Severe conduction disturbance including clinically significant QTC prolongation \> 450 ms (unless pacemaker in place)
* Active or chronically recurrent bleeding (e.g., active peptic ulcer disease)
* Clinically relevant active infection
* Known positive serology for human immunodeficiency virus (HIV)
Non-pharmacological Interventions for Preschoolers With Attention Deficit Hyperactivity Disorder (ADHD)

This study is designed to evaluate two potential treatments for children with Attention-deficit/Hyperactivity Disorder (ADHD) that do not involve the use of medication. Our goal is to develop new interventions for preschoolers with ADHD that will result in enduring reductions of ADHD symptoms and associated impairments in children, and thus prevent long-term difficulties characteristic of many children with ADHD.

Both interventions involve weekly playgroups (of roughly five children) in which children engage in designated activities while parents engage in groups focusing on parent education, support, and their children's activities. It is hypothesized that both interventions will be helpful, but that only one will have lasting effects well beyond the end of active treatment.

Children eligible for this study are:

* 4 and 5 years-old (between the ages of 48 - 72 months)
* shows signs and symptoms of hyperactivity, impulsiveness and/or inattention. To enter the study, following our evaluation, they will need to meet diagnostic criteria for ADHD
* enrolled in a preschool or daycare setting

Children are ineligible to participate in this study if they:

* are currently being treated with psychotropic medication
* have a diagnosed neurological disorder
* have an autism spectrum pr pervasive developmental disorder
* are intellectually impaired
* are highly physically aggressive

Eligibility Criteria:
Inclusion Criteria:

* Child is hyperactive
* Child meets criteria for ADHD
* Child attends preschool or kindergarten
* Family speaks English at home

Exclusion Criteria:

* Family does not speak English at home
* Child does not attend preschool/kindergarten
* Child is diagnosed with or suspected of having PDD
* Child has IQ of less than 80
* Child is being treated with psychotropic medication
* Child has a diagnosed neurological disorder
* Child is aggressive
* Child is only inattentive and does not exhibit signs of hyperactivity
* Parent has attended parent management classes
* Child is not physically able to participate in group play sessions