cyrilzakka/clinical-trials huggingface dataset:
Evaluation of Long-Term Clinical Acceptability and Satisfaction With the IC-8 Intraocular Lens

The purpose of this study is to evaluate the long-term clinical acceptability and overall satisfaction with the IC-8 IOL at least 12 months post-IOL implantation.

This will be a prospective, multi-center, non-interventional study in up to 80 patients previously implanted with an IC-8 IOL contralaterally or bilaterally under the protocol ACU-P14-029 at up to nine clinical sites within Europe.

The purpose of this study is to demonstrate the long-term clinical acceptability and overall satisfaction in patients implanted with the IC-8 IOL. The primary study endpoint is binocular target-corrected near visual acuity (TCNVA) of 20/32 or better in 85% or more patients at least 12 months post-implantation. The secondary study endpoint is overall satisfaction with postoperative vision in 85% or more patients reporting either satisfied or very satisfied at least 12 months post-implantation.

Eligibility Criteria:
Inclusion Criteria:

1. Patients previously implanted contralaterally or bilaterally with the IC-8 IOL under the protocol ACU-P14-029 and have had the IOL implanted for a duration of at least 12 months and currently have the IC-8 IOL in the eye.
2. Availability, willingness, ability and sufficient cognitive awareness to comply with examination procedures at the study visit.
3. Signed informed consent.

Exclusion Criteria:

1. Patients who have developed systemic or ocular pathology, not related to the IOL that affected their best corrected distance visual acuity to be 0.8 decimal or worse as determined by diagnostic testing or investigator's medical judgment. -
The Effects of Exercises With Pilates Ball on Balance, Reaction Time and Dual-task Performance of Kindergarten Children

The aim of this study is to investigate the effects of exercises conducted with pilates ball on balance, reaction time, quality of life, and behavior among preschool children.

60 volunteers, aged 4 and 5 years old, who continue kindergartens will randomly be grouped into two as study group (SG) (n=30) and control group (CG) (n=30). Exercises including pilates ball will be applied to SG children for 40 minutes, twice a week, 6 weeks. CG will continue normal daily routines for 6 weeks.

Sociodemographic information of all people will be recorded after their parents signed informed consent form. Single Leg Standing (eyes open and close) for static balance, Functional Reach Test (FRT)for dynamic balance, Ruler Drop Test for reaction time, dual task performance methods will be used.

Exercises are generally suggested starting from primary school children. However, exercise habit should be given to people from earlier ages. Moreover, doing exercise can be beneficial to improve motor skills of this age and this improvement can support other developmental areas of these children. Thus, this study aims to investigate the effects of an exercise routine on balance, reaction time and dual task performance of preschool children. This exercise program includes pilates ball to make more fun for this age group. All movements are conducted with the same pilates ball. Exercises are conducted with individual sessions in the kindergartens of children.

Eligibility Criteria:
Inclusion Criteria:

* having a birth year 2015 or 2016.

Exclusion Criteria:

* Having cognitive, physical and/or orthopedic problem
* Any pain which may prevent doing exercise
* Having visual and/or auditory loss
Safety and Tolerability During Open-label Treatment With LCZ696 in Patients With CHF and Reduced Ejection Fraction

The purpose of this study was to collect safety and tolerability data on LCZ696 in eligible PARADIGM-HF patients who received open-label investigational drug. The parent PARADIGM-HF (NCT01035255) trial was terminated early due to compelling efficacy of LCZ696 in patients with heart failure with reduced ejection fraction (HFrEF) after the final pre-specified interim analysis in March 2014.


Eligibility Criteria:
Inclusion Criteria:

1. Written informed consent for the extension must be obtained before any assessment is performed.
2. Patients who have completed PARADIGM-HF (protocol CLCZ696B2314) and are able to be safely enrolled into the open-label trial as judged by the investigator.

Exclusion Criteria:

1. Use of other investigational drugs at the time of enrollment, or within 30 days or 5 half-lives of enrollment, whichever is longer
2. History of hypersensitivity or allergy to any of the study drugs, drugs of similar chemical classes, ACEIs, ARBs, or NEP inhibitors as well as known or suspected contraindications to LCZ696
3. Known history of angioedema
4. Requirement of simultaneous treatment with both ACEIs and ARBs
5. Current acute decompensated HF (exacerbation of chronic HF manifested by signs and symptoms that may require intravenous therapy)
6. Symptomatic hypotension and/or a SBP \< 100 mmHg at Visit 1 (screening)
7. Estimated GFR \< 30 mL/min/1.73m\^2 as measured by the simplified MDRD formula at Visit 1 (screening)
8. Presence of bilateral renal artery stenosis
9. Serum potassium \> 5.2 mmol/L at Visit 1 (screening)
10. Evidence of hepatic disease as determined by any one of the following: AST or ALT values exceeding 3 x ULN at Visit 1, history of hepatic encephalopathy, history of esophageal varices, or history of portacaval shunt
11. Pregnant or nursing (lactating) women
12. Women of child-bearing potential
13. Any condition, not identified in the protocol, that in the opinion of the investigator is likely to prevent the patient from safely tolerating LCZ696 or complying with the requirements of the study.
Management of Direct Oral Anti-Coagulants (DOACs) for Gastrointestinal Endoscopy Procedures

The use of Direct Oral Anti-Coagulants (DOACs) is expanding, but their proper management in patients undergoing endoscopic procedures is still not completely clear. Current European guidelines are based on weak data. This observational study aims to evaluate the peri-endoscopic management of DOACs in clinical practice and the incidence of adverse events.

This observational study is aimed at evaluating the peri-endoscopic management of DOACs in patients undergoing elective gastrointestinal endoscopy procedures and the adverse events (bleeding and thromboembolic events) associated with.

All consecutive patients undergoing elective procedures and providing informed consent will be included.

Primary end-point:

incidence of major bleeding events according to International Society Thrombosis Haemostasis (ISTH) criteria and clinically relevant non-major bleeding events occuring during the endoscopy procedures or within 30 days, according to International Society Thrombosis Haemostasis (ISTH) criteria in patients in which DOACs have been managed according to European Society of Gastrointestinal Endoscopy (ESGE) guidelines

Secondary end points:

* incidence of major bleeding and clinically relent non-major events in the overall patient population
* incidence of bleeding events in the overall patient population
* incidence of thromboembolic events in the overall patient population and in patients in which DOACs have been managed according to ESGE guidelines
* compliance with ESGE guidelines

Eligibility Criteria:
Inclusion Criteria:

* patients (both inpatients and outpatients) undergoing endoscopic procedures during DOACs therapy

Exclusion Criteria:

* inform consent not possible to obtain
* not willing patient
Study Comparing Two Types of Psychotherapy for Treating Depression and Substance Abuse

The purpose of this study is to determine whether Integrated Cognitive Behavioral Therapy or Twelve Step Facilitation Therapy is most effective for treatment of dually diagnosed veterans with depressive and substance use disorders.

Depression is the most frequent co-occuring mental health disorder among adults with substance use disorders, and such comorbidity is often associated with poorer treatment outcomes. Although there is an urgent need for effective treatments specific for dual-diagnosis adults, few studies have been conducted to address this need.

Comparison: This study will compare substance use and depression symptoms of individuals in two different psychotherapy groups: Integrated Cognitive Behavioral Therapy and Twelve Step Facilitation Therapy. Symptoms and substance use will be compared during the active treatment phase (24 weeks) and for one year following the end of the active treatment.

Eligibility Criteria:
Inclusion Criteria:

* Individuals diagnosed with one or more substance use disorders (alcohol, cannabis, and or stimulant abuse/dependence) and an independent co-occurring depressive disorder (major depression or dysthymia) will be included.

Exclusion Criteria:

* Individuals with substance induced mood disorders and individuals experiencing persistent psychotic symptoms.
* Those with life threatening or unstable medical illness, neurological disorders, or inability to read will be excluded.
* Individuals currently prescribed steroids, disulfiram, or long acting benzodiazepines will be excluded.
Safety Evaluation of the Vibrating Capsule

The study will assess the safety of the vibrating capsule in healthy volunteers first and than for constipation relief constipated individuals.

Healthy volunteers will be followed for safety for 7 days after taking the capsule.

Constipated individuals will be first followed for 2 weeks and than they will use the capsule for 7.5 weeks period. Safety and efficacy will be evaluated.

Eligibility Criteria:
Inclusion Criteria:

* Patients age 18-60 years
* Ability of subject to understand character and individual consequences of clinical trial
* Written informed consent must be available before enrollment in the trial
* For women with childbearing potential, adequate contraception

Exclusion Criteria:

* Patient with Diverticulosis
* Patient must not use protocol-defined prohibited medicine
* History of or current diagnosis of cardiovascular ischemic disease (e.g., angina pectoris, myocardial infarction, transient ischemic attack or stroke and including findings suggestive of ischemia on an ECG such as changes in ST segment and T waves, and / or Q wave)
* Clinical evidence of significant (as judged by the Investigator) respiratory, cardiovascular, renal, hepatic-biliary, endocrine, psychiatric or neurologic diseases or presence of abdominal adhesions
* Presents of pacemakers
* History of or current eating disorder such as anorexia or bulimia or compulsory overeating.
* Diagnosis of mega-rectum or colon, a history of intestinal obstruction, congenital anorectal malformation, clinically significant rectocele, or any evidence of intestinal structural abnormality including gastrointestinal resection that affected bowel transit or any evidence of intestinal carcinoma, of inflammatory bowel disease or of alarm symptoms such as weight loss, rectal bleeding, or anemia.
* Actively participating in another clinical trial
Effects of Liquid Zinc Supplementation and Dispersible Zinc Tablets on Plasma Zinc Concentration

The study aims to compare the effects of two different formulations of zinc supplements on plasma zinc concentrations among young Burkinabe children.

1) To investigate the effects of short-term zinc supplementation, provided either as a dispersible tablet containing zinc sulfate ("ZinCfant," Nutriset Ltd; Malaunay, France) or as a liquid ZnSO4 solution, on changes in serum zinc concentration, compared with a placebo in young Burkinabe children; and 2) to assess the relationship between change in serum zinc concentration and the presence of altered intestinal permeability within each treatment group.

Eligibility Criteria:
Inclusion Criteria:

* currently breast feeding
* informed consent of a parent or guardian.

Exclusion Criteria:

* symptomatic acute or chronic febrile infections
* diarrhea within the past week
* consuming vitamin or mineral supplements or zinc-fortified infant formulas
The Effect of Respiratory Muscle Training for Patients With COPD and Mild Cognitive Impairment

Patients with COPD and MCI received either inspiratory muscle training or inspiratory plus expiratory muscle training and compared the therapeutic effects

Patients with COPD and MCI were recruited, and were randomly assigned to the experimental group and the control group. The experimental group consisted of EMT and IMT for a total of 8 weeks, while the control group received IMT only. Outcomes measured and compared in this cohort were diaphragmatic thickness fraction and excursion examined by ultrasound, the dyspnea score of modified Medical Research Council (mMRC), the cognitive score of Mini-Mental State Examination (MMSE), and the score of COPD Assessment Test (CAT). In addition, the pulmonary function test, the cardiopulmonary exercise test, and the physiology performance of six minute walking test were also obtained. We also analyzed the difference of each parameters before and after training in each patient.

Eligibility Criteria:
Inclusion Criteria:

* 1. Having definite diagnosis of COPD, namely the value of the FEV1 divided by forced vital capacity (FVC) 10 to 15 minutes after beta-2 agonist inhalation being less than 0.7.
* 2. The score of Mini-Mental State Examination (MMSE) being between 23 and 27

Exclusion Criteria:

* 1. Being not able to follow instructions on respiratory muscle training or complete the questionnaires of our study due to cognitive impairment.
* 2. Having difficulty to complete the cardiopulmonary exercise testing or the six minute walking test (6MWT) due to high risk cardiopulmonary diseases or other orthopedic conditions.
* 3. Having the diagnosis of lung cancer or history of receiving thoracoabdominal surgery
* 4. Having Body Mass Index more than 30
Patient Registry Study of Berinert® in Normal Clinical Practice

The objective of this patient registry is to collect data on the safety of Berinert® in normal clinical practice in the United States. The patient registry will be maintained for a period of at least 3 years. The duration of individual patient participation will vary and is determined by the frequency of hereditary angioedema (HAE) attacks and the patient's need for Berinert® treatment.


Eligibility Criteria:
Inclusion Criteria:

* Any patient receiving CSL Behring's C1-esterase inhibitor
* Written informed consent (may not be required for some retrospective chart review cases)

Exclusion Criteria:

* Any patient participating in an HAE study using other C1-inhibitors than Berinert®
Effect of 2000-meter Rowing Test on Parameters of Intestinal Integrity in Elite Rowers During Competitive Phase

The study aimed to check the 2000m ergometer test on markers of gut permeability in the competitive phase of rowers. 18 members of the Polish rowing team took part in the study.

The phenomenon of epithelial wall leakage has been the subject of investigations within athletic domains such as running and cycling. Nevertheless, there exists an insufficiency of understanding regarding gut permeability in alternative disciplines, such as rowing, particularly following the completion of a standard competitive distance of 2000 meters. Hence, the principal objective of our study was to assess gut permeability after completing a 2000-meter rowing test. The study was performed at the beginning of a competitive training phase. Eighteen elite Polish Rowing Team rowers participated in the study after applying the inclusion/exclusion criteria. The participants performed a 2000-meter ergometer test. Blood samples were taken before the test, after exercise, and after 1-hour of restitution. Parameters, such as I-FABP, LPS, LBP, and zonulin, were determined using appropriate biochemical tests.

Eligibility Criteria:
Inclusion Criteria:

* minimum five years of training,
* five training sessions per week minimum,
* total training time minimum of 240 minutes,
* membership in the Polish Rowing Team,
* finishing the 2000-meter ergometer test.

Exclusion Criteria:

* antibiotic therapy within the last three months,
* probiotics and prebiotics within the last three months,
* dietary regime,
* gastrointestinal diseases.
Changes in Bone Mineral Density and Fracture Risk in Patients Receiving Androgen Deprivation Therapy for Prostate Cancer

The aim of this study is to determine the long term effects of two types of hormonal treatment for advanced prostate cancer (LHRH agonists and the antiandrogen bicalutamide)on the bone mineral density of patients.

Androgen ablation is the mainstay of treatment for advanced prostate cancer. However,luteinizing hormone-releasing (LHRH) agonists are associated with accelerated bone loss, osteoporosis and fractures. An alternative is the non steroidal antiandrogen, bicalutamide, which acts at the androgen receptor and maintains serum testosterone levels. Our aim was to assess the effects of these two treatments on bone mineral density (BMD) of selected groups of patients, based on their BMD at presentation. All patients will undergo peripheral bone densitometry of the forearm, using dual energy X-ray absorptiometry. Osteoporotic patients, at high risk of fractures, will be commenced on bicalutamide. Osteopenic and normal BMD patients will be commenced on LHRH agonists. All osteopenic and osteoporotic patients will be given calcium and vitamin D supplementation.Patients will undergo annual bone densitometry scans, and will be seen in the clinic every 3 months to monitor well-being and PSA levels. Any patient who fails to respond or escapes treatment with hormone monotherapy will be managed according to the clinical situation by either being switched to a combination of LHRH and bicalutamide or additional oestrogen therapy.

Eligibility Criteria:
Inclusion Criteria:

* Patients will locally advanced prostate cancer for whom immediate androgen deprivation was indicated

Exclusion Criteria:

* Previous systemic therapy for prostate cancer
* Patients with any illness or medication that would affect bone and mineral metabolism
* Severe hepatic or renal insufficiency
Safety, Tolerability, Pharmacokinetics and Efficacy of SPR720 for the Treatment of Patients With Mycobacterium Avium Complex (MAC) Pulmonary Disease

To evaluate the pharmacokinetics (PK) of SPR719, the active moiety, generated from the orally (po) administered SPR720 prodrug in a patient population with nontuberculous mycobacteria pulmonary disease (NTM-PD)


Eligibility Criteria:
Inclusion Criteria:

* Has a diagnosis of NTM-PD due to MAC
* Had at least 1 prior positive culture (sputum or bronchoalveolar lavage) positive for MAC in the previous 6 months
* Has an induced sputum culture at screening positive for MAC by at least one of the following methods performed by the microbiology laboratory: quantitative culture on solid agar or growth on liquid media (MGIT)
* Is either treatment naïve and has not received any prior treatment for MAC, OR if previously treated for MAC, has culture evidence of persistent, recurrent, or relapsed disease and has been off therapy for at least 6 months
* In the opinion of the Investigator, is ready to initiate treatment (treatment naïve) or reinitiate treatment (previously treated) within the next 3 months, and for whom a delay, in order to participate in a placebo-controlled clinical trial, is considered reasonable and clinically acceptable
* Had clinical signs and symptoms within the 6 weeks before the date of consent that are consistent with NTM-PD with at least two of the following:

  1. chronic cough
  2. fatigue
  3. frequent throat clearing
  4. shortness of breath (dyspnea)
  5. coughing up of blood (hemoptysis)
  6. excessive mucus (sputum) production
  7. fever
  8. night sweats
  9. loss of appetite
  10. unintended weight loss
  11. wheezing
  12. chest pain
* Has a measured forced expiratory volume in 1 second (% predicted FEV1) ≥30% on pulmonary function test within 3 months prior to consent
* Has a chest radiograph (CXR) or computed tomography (CT) scan within 6 months prior to consent with findings consistent with NTM-PD. If no CXR or CT scan is available, a CXR or CT scan should be performed at screening to confirm eligibility.
* Other inclusion criteria per protocol

Exclusion Criteria:

* Has disseminated or extrapulmonary NTM
* Has end-stage NTM-PD or treatment-refractory NTM-PD and is unlikely to respond to protocol-specified SOC treatment
* Had isolation on sputum cultures of any species of Mycobacterium other than a species included in MAC within the past 6 months
* Had prior isolation of MAC with macrolide resistance
* Has received any systemic (oral or IV) or inhaled antibiotic with activity against MAC between consent and randomization
* Has a potentially confounding underlying pulmonary disease, including but not limited to cystic fibrosis, active pulmonary malignancy (primary or metastatic), NTM-hypersensitivity disease pneumoconiosis, or another advanced lung disease with a % predicted FEV1\<30%
* Other exclusion criteria per protocol
OMS721 Compassionate Use in Patients With Thrombotic Microangiopathy

The purpose of this compassionate use study, for two patients with thrombotic microangiopathy, is to provide expanded access to patients who have participated in the clinical trial OMS721-TMA-001 and in whom improvement in their disease markers was observed while on treatment or to patients who could otherwise benefit from the treatment. This is a treatment protocol; not a research protocol.Therefore, only patients in study OMS721-TMA-001 deemed eligible by the investigator may participate.

The study is open-label, expanded access study to provide continued OMS721 treatment for compassionate use to patients who have participated in clinical trial OMS721-TMA-001. Patients will be eligible if markers of disease activity, such as platelet count, LDH, and haptoglobin, were observed to improve during the study or if the patients disease activity remained stable, but they could be treated with a higher dose that may be beneficial. Safety measures of adverse events and laboratory measures will be monitored. Markers of disease activity, pharmacokinetics and ex vivo pharmacodynamics will also be monitored.

Eligibility Criteria:
Inclusion Criteria:

* Have a diagnosis of thrombotic microangiopathy related to aHUS, TTP or stem cell transplant.
* Have completed treatment in clinical trial OMS721-TMA-001.
* Investigator determined that continued treatment with OMS721 could be beneficial.
* Aged 18 years or older.

Exclusion Criteria:

* Hypersensitivity to OMS721 or any excipients.
* Have a serious medical condition that increases the risk of OMS721 treatment to the patient.