cyrilzakka/clinical-trials huggingface dataset:
Effectiveness of Telerehabilitation in Total Knee Arthroplasty

In patients who have had joint replacement surgery, there is a shortage of concrete evidence regarding the effectiveness of telerehabilitation. The aim of this study is to compare telerehabilitation with home based exercise program and standard home exercise program in total knee arthroplasty.

The primary aim of our study is to assess the effectiveness of telerehabilitation in comparison to the conventional approach, specifically focusing on particular parameters, in the context of post-total knee arthroplasty surgery. This investigation will entail a comparative analysis between a home exercise program prescription supplemented with visual and video resources using telerehabilitation and the conventional home exercise program prescription.

The aim of our study is comparison between two exercise prescription modalities : a standard home exercise program and an internet-based program utilizing the Rehab My Patient software with visual and video support, in addition to telerehabilitation program, which involves exercise prescription oversight via video consultations. This comparison will include the following parameters : range of motion, proprioception , function, kinesiophobia, pain , patient adherence, patient satisfaction and Quadriceps muscle strength.

Eligibility Criteria:
Inclusion Criteria:

* Participants aged 50 and over
* Having a primary total knee arthroplasty surgery
* To possess a device, such as a smartphone or tablet, that enables access to mobile applications.
* To have the capability to use the internet and to have internet access.
* Proficiency in reading and writing in the Turkish language
* Having a Mini-Mental State Examination(MMSE) score of 24 or higher
* To be willing to participate in the study

Exclusion Criteria:

* Having cognitive problem
* Having a secondary total knee arthroplasty surgery
* Havig a revision surgery
* Having a history of cerebrovascular and/or cardiovascular events in the last 3 months
* Having uncontrolled diabetes and/or hypertension
* Having a arthrogenic muscle inhibition
An Extension Study Assessing the Efficacy and Safety of Brolucizumab in a Treat-to-Control Regimen in Patients With Neovascular Age-related Macular Degeneration Who Have Completed the CRTH258A2303 (TALON) Study

The purpose of this extension study was to evaluate the efficacy and safety of brolucizumab used in a Treat-to-Control-regimen for treatment of patients with neovascular age-related macular degeneration who have completed the CRTH258A2303 (TALON) study. The main objective was to assess brolucizumab's potential for long durability up to 20 weeks.

All eligible participants were treated with brolucizumab regardless of their treatment in the TALON study.

The study period was 56 weeks including post-treatment follow-up.

This was a 56-week, open-label, one-arm extension study in subjects who had completed the CRTH258A2303 (TALON) (NCT04005352) study, referred to as the core study in this document. Subjects who provided written informed consent and met all the inclusion and none of the exclusion criteria were enrolled into this extension study to receive brolucizumab 6 mg in a treat-to-control (TtC) regimen, irrespective of the treatment received in the core study.

The maximum study duration for a subject was 56 weeks, including post-treatment follow-up.

There were two periods in this study:

* Treat-to-Control treatment period: from Baseline (Day 1) to Week 52
* Post-treatment follow-up period: from Week 52 to Week 56.

All participants were treated with brolucizumab regardless of their treatment in the TALON study (brolucizumab or aflibercept).

Treatment intervals were then extended by 4 weeks at a time based on the investigator's judgment of visual and/or anatomic outcomes. The treatment intervals were to have been 4 weeks at a time if disease activity recurs.

Eligibility Criteria:
Inclusion Criteria:

1. Signed informed consent
2. Successfully completed TALON core study at week 64 (End of Study)

Exclusion Criteria:

1. Medical condition or personal circumstance which precludes study participation or compliance with study procedures, as assessed by the Investigator
2. Discontinued study treatment in the core study
3. Anti-VEGF treatment is futile in the study eye, in the Investigator's opinion.
4. Pregnant or nursing (lactating) women
5. Women of child-bearing potential not using highly effective methods of contraception
Hypothalamic-Pituitary-Adrenal (HPA) Axis Study in Adult and Adolescent Subjects With Perennial Allergic Rhinitis (PAR)

The purpose of the study is to evaluate the effects of BDP HFA Nasal Aerosol on HPA-axis function.


Eligibility Criteria:
Inclusion Criteria:

* Informed Consent
* Male or female subjects 12-45 years of age
* Documented history of perennial allergic rhinitis
* General good health
* Other criteria apply

Exclusion Criteria:

* History of physical findings of nasal pathology (within 60 days prior to Screening Visit 1)
* Participation in any investigational drug study 30 days preceding Screening Visit 1
* History of respiratory infection/disorder with 14 days preceding Screening Visit 1
* Use of any prohibited concomitant medications
Nanocrystalline Hydroxyapatite Bone Substitute for Treating Periodontal Intrabony Defects

The present clinical trial included 20 patients (11 females and 9 males, aged 36 to 56 years) suffering from moderate or advanced chronic periodontitis. Subjects were recruited from the outpatient clinic, Department of Oral Medicine and Periodontology, Faculty of Dentistry, Cairo University. This clinical trial was meant to assess clinically and radiographically the possible predictable results regarding the use of nanocrystalline hydroxyapatite bone graft substitute together with open flap debridement versus open flap debridement alone in the treatment of periodontal intrabony defects.

periodontal intrabony defects in patients with moderate or advanced chronic periodontitis were treated with open flap debridement only in the control group while open flap debridement and Nanocrystalline Hydroxyapatite bone graft substitute was performed for the intervention group. probing pocket depth, clinical attachment level, gingival index, plaque index, gingival recession and bone defect area were assessed at baseline and six months post surgically to evaluate the possible improvement in the clinical and radiographic outcomes.

Eligibility Criteria:
Inclusion Criteria:

* systemically healthy patients
* diagnosed with moderate to advanced chronic periodontitis
* periodontal defects with at least one site with probing pocket depth (PPD) ≥ 5mm, clinical attachment loss (CAL) ≥ 4mm and two or three-walled intra-bony defects ≥ 3mm
* evidence of intrabony defects using periapical radiographs

Exclusion Criteria:

* teeth with suprabony defects or 1-wall intrabony defects
* pregnant or lactating women
* patients taking any medication 3 months prior to the study
* patients receiving any periodontal treatment 6 months prior to study initiation
* former or current smokers.
Relapse Prevention Study of Pimavanserin in Dementia-related Psychosis

The purpose of this study is to evaluate the efficacy of pimavanserin compared to placebo in preventing relapse of psychotic symptoms in subjects with dementia-related psychosis who responded to 12 weeks of open label pimavanserin treatment.


Eligibility Criteria:
Inclusion Criteria:

1. Meets criteria for All-cause Dementia according to NIA-AA guidelines
2. Meets clinical criteria for one of the following disorders: Dementia associated with Parkinson's disease, Dementia with Lewy bodies, Possible or probable Alzheimer's disease, Frontotemporal degeneration spectrum disorders, Vascular dementia
3. Has an MMSE score ≥6 and ≤24
4. Has had psychotic symptoms for at least 2 months
5. Must be on a stable does of cholinesterase inhibitor or memantine, if applicable
6. If the subject is female, she must not be pregnant or breastfeeding. She must also be of non-childbearing potential or must agree to use a clinically acceptable method of contraception for the duration of the study

Exclusion Criteria:

1. Has psychotic symptoms that are primarily attributable to a condition other than dementia
2. Has had a recent major depressive episode
3. Has experienced suicidal ideation or behavior within 3 months prior to study enrollment
4. Has evidence of a non-neurologic medical comorbidity or medication use that could substantially impair cognition
5. Has a history of ischemic stroke within the last 12 months or any evidence of hemorrhagic stroke
6. Has a known history of cerebral amyloid angiopathy (CAA), epilepsy, CNS neoplasm, or unexplained syncope
7. Has any of the following: greater than New York Heart Association (NYHA) Class 2 congestive heart failure, Grade 2 or greater angina pectoris, sustained ventricular tachycardia, ventricular fibrillation, torsade de pointes, syncope due to an arrhythmia, an implantable cardiac defibrillator
8. Had a myocardial infarction within the last 6 months
9. Has a known personal or family history or symptoms of long QT syndrome
10. Has a significant unstable medical condition that could interfere with subject's ability to complete the study or comply with study procedures
11. Requires treatment with a medication or other substance that is prohibited by the protocol

Additional inclusion/exclusion criteria apply. Subjects will be evaluated at screening to ensure that all criteria for study participation are met.
Safety and Efficacy of Solithromycin in Adolescents and Children With Community-Acquired Bacterial Pneumonia

This is a phase 2/3, randomized, open-label, active control, multi-center study to assess the safety and efficacy of solithromycin in children and adolescents with community-acquired bacterial pneumonia (CABP).

Subjects who meet all inclusion/exclusion criteria and sign the informed consent/assent were enrolled. Subjects were randomized to receive solithromycin or a comparator antibiotic, administered IV and/or by mouth (PO) based on weight and age. Subjects were treated daily for 5 to 7 days with oral solithromycin and 5 to 7 days with IV or IV-to-oral solithromycin. Subjects were treated for 5 to 10 days with comparator antibiotics. Subjects received safety and efficacy assessments during and after treatment.

Eligibility Criteria:
Inclusion Criteria:

* History of and/or documented fever (rectal, ear, or oral temperature ≥38°C or axillary temperature ≥37.5°C) or hypothermia (rectal, ear, or oral temperature \<35°C or axillary temperature \<34.5°C)
* Chest radiograph infiltrates consistent with bacterial pneumonia (or pneumonia caused by atypical bacterial agents); if a subject is outpatient and starting on oral therapy, a radiograph is not required.
* Presence of at least 2 of the following signs or symptoms:
* Cough
* Difficulty breathing
* Production of purulent sputum
* Chest pain
* Grunting
* Hypotension
* Tachycardia, defined as follows:

  2 months to \<24 months: ≥160 beats/min 24 months to \<10 years: ≥140 beats/min
  * 10 years: ≥100 beats/min
* Tachypnea, defined as follows:

  2 months to \<12 months: ≥50 breaths/min 12 months to \<5 years: ≥40 breaths/min
  * 5 years: ≥20 breaths/min
* Physical exam consistent with pulmonary consolidation
* Presence of at least 1 of the following:
* Leukocytosis (≥12,000 white blood cells \[WBC\]/mm3)
* Leukopenia (\<5000 WBC/mm3)
* ≥10% immature neutrophils (bands) regardless of total peripheral WBC
* Elevated inflammatory markers (C-reactive protein or procalcitonin)
* Oxygen saturation \<97% on room air
* Organism consistent with a typical respiratory pathogen identified

Exclusion Criteria:

* Ventilator-associated or hospital-acquired pneumonia
* \>48 hours of systemic antibacterial therapy
* confirmed or suspected bacterial meningitis
* breast-feeding females
* positive pregnancy test
Efficacy and Safety Comparison of Tiotropium Inhalation Solution (Respimat Inhaler) and Spiriva HandiHaler in COPD

Non-inferiority of lung function response to Tiotropium inhalation solution compared to Spiriva HandiHaler


Eligibility Criteria:
Inclusion criteria:

* All patients had to sign an informed consent consistent with International Conference of Harmonization-Good Clinical Practice (ICH-GCP) guidelines prior to participation in the trial, which includes medication washout and restrictions.
* All patients had to have a diagnosis of chronic obstructive pulmonary disease.
* Patients had to have relatively stable, moderate to severe airway obstruction with an forced expiratory volume in one second (FEV1) ≤ 60% of predicted normal and FEV1 ≤ 70% of forced vital capacity FVC (Visits 1 and 2).
* Male or female patients 40 years of age or older.
* Patients had to be current or ex-smokers with a smoking history of more than 10 pack-years.
* Patients had to be able to perform technically acceptable pulmonary function tests and peak expiratory flow rate (PEFR) measurements, and had to be able to maintain records (Patient Daily Diary Card) during the study period as required in the protocol.
* Patients had to be able to inhale medication in a competent manner from the Respimat inhaler, the HandiHaler and from a metered dose inhaler (MDI).

Exclusion criteria:

* Patients with significant diseases other than chronic obstructive pulmonary disease (COPD) had to be excluded. A significant disease was defined as a disease which in the opinion of the investigator may either put the patient at risk because of participation in the study or a disease which may influence the results of the study or the patient's ability to participate in the study.
* Patients with clinically relevant abnormal baseline haematology, blood chemistry, or urinalysis, if the abnormality defines a significant disease as defined in exclusion criterion No. 1.
* Patients with a recent history (i.e., one year or less) of myocardial infarction.
* Patients with any cardiac arrhythmia requiring drug therapy or who had been hospitalised for heart failure within the past three years.
* Patients with a history of cancer within the last five years. Patients with treated basal cell carcinoma were allowed.
* Patients with known symptomatic prostatic hypertrophy or bladder neck obstruction.
* Patients with known narrow-angle glaucoma.
* Patients with a history of asthma, allergic rhinitis or who have a total blood eosinophil count ≥600 mm3.
* Further exclusion criteria apply
TraStuzumAb-Radiotherapy : Impact on the Cerebral Prevention

Evaluate the survival without metastasis in patients treated by Trastuzumab in association with other chemotherapies for a breast cancer expressing HER2-NEU.


Eligibility Criteria:
Inclusion Criteria:

* Patients with breast cancer, expressing HER2-NEU (score +++ in ICH or ++ and amplification on FISH or CISH, SISH)
* Visceral metastasis, only or multiple
* First line metastasis treatment by Trastuzumab in association with chemotherapy
* Good general conditions: OMS=\<2 or Karnofsky \>=70%
* Age \> 18 years and \< 70 years
* Life expectancy \>=3 mois
* No Trastuzumab since more of 6 months
* No cerebral metastasis (MRI)
* Efficacy contraception for women with genital capacities
* Consent signed by the patient

Exclusion Criteria

* Contraindication to IRM
* Psychiatric decease
* Prior cerebral radiotherapy,
* Geographical constraint, compromising the fallow of patients
* Infectious or other serious pathology, likely to stop the treatment
* Positive serology (HIV, hBC, hBS)
* Inclusion in an other clinical trial or in the 4 weeks before th inclusion
* Pregnant or breastfeeding women
Cardiac Implantable Electronic Device Implantation With and Without Pectoral Nerve Block

Implantation of cardiac implantable electronic devices are generally carried out using intermittent intravenous conscious sedation combined with local anaesthesia. The main advantage of this technique is in avoiding the potential risks of general anaesthesia. However, the use of this Sedation - Local Anaesthesia technique is not without complications. Peri -procedural hypoxaemia and hypotension are well recognised complications of this technique.

The pectoral nerves (Pecs) blocks are novel techniques to block the pectoral, intercostobrachial, third to sixth intercostals, and the long thoracic nerves. PECS block targets the lateral and median pectoral nerves at an interfascial plane between the pectoralis major and minor muscles.

A case report by Fujiwara et al has described the use of this technique to provide good analgesia during and after these implantation procedures surgery. Pectoral nerves block along with minimal sedation has been used as a safe technique in our local set up as well.

Hence, we propose a randomized, single center, controlled trial on patients undergoing cardiac implantable electronic device implantation with local anaesthesia and sedation with and without Pectoral Nerve Block.

Intervention group:

Pectoral nerve block will be performed by anaesthetist (not blinded) in cardiac catheterization laboratory using ultrasound guidance and strict aseptic technique.

Control group:

A sham "block" will be performed by anaesthetist in cardiac catheterization laboratory using strict aseptic technique.

Patients of both groups will be monitored by the Cardiologist ( performing the procedure) and the Nurse from the monitoring room.

A minimum period of 15 minutes will be allowed following the block, prior to device implantation procedure by cardiologist.

Numeric rating scale (NRS) will be used for assessment of pain. The assessment will be carried out at every 15 minutes from the start of the procedure till the end of the procedure (0, 15, 30, 45, 60 minutes etc) and also at specific time points. Numerical rating scale will also be assessed when the patient experiences pain at any point and in the recovery room (0, 15, 30 and if needed, 45, 60 minutes).

Further post-operative pain scores will be collected at 4 hours and 8 hours post-procedure.

Eligibility Criteria:
Inclusion Criteria:

* Fulfilled the indication for CIED implantation as defined in 2008 guidelines for device-based therapy of cardiac rhythm abnormalities

Exclusion Criteria:

* Pregnant
* Those who receives subcutaneous implantable cardioverter defibrillator
* Vulnerable subjects (children, prisoners, cognitive impaired persons)
* Known history of allergy to local anaesthetic medications
Phase 0 of 18F FPM Using PET/CT in Patients With a Variety of Malignancies

The purpose of this study is to investigate the safety and potential effectiveness of the imaging compound 18F FPM for finding sites of malignancies.


Eligibility Criteria:
Inclusion Criteria:

* Written informed consent obtained prior to any protocol-specific procedures
* Male and female patients with histologically confirmed squamous cell carcinoma
* At least one site of active malignancy, as demonstrated on the pre-study 18F FDG PET/CT scan performed as part of routine clinical care
* Age \>/= 18 years
* Life expectancy \>/= 3 months
* ECOG Performance score of 0-2

Exclusion Criteria:

* Pregnant or breastfeeding females
* Systemic anti-neoplastic therapy within the 2 weeks prior to the pre-study 18F FDG PET/CT scan until after the 18F FPM PET/CT scan
* Any serious medical condition which the investigator feels may interfere with the procedures or evaluations of the study
* Patients unwilling or unable to comply with protocol or with a history of non-compliance or inability to grant informed consent
Physical Therapy in Pregnant Women With Preeclampsia

The aim of this study is to evaluate the influence that has a physical therapy protocol in maternal and fetal hemodynamics in relation to blood pressure, maternal and fetal responses and perinatal outcomes.

The hypertensive disorders in pregnancy affecting 5-8% of pregnant women worldwide, contributing significantly to maternal and fetal complications. Various forms of hypertensive disorders occurring during pregnancy, including preeclampsia and chronic hypertension with superimposed preeclampsia. These two disorders present with high blood pressure and proteinuria, and often lead to the hospitalization of pregnant women.

The objective is to evaluate the effectiveness of a physical therapy protocol used in pregnant women with preeclampsia on blood pressure, maternal-fetal outcomes and perinatal outcomes.

Participants in the study pregnant women with preeclampsia and hypertension with superimposed pre-eclampsia, hospitalized, with no significant complications that may impair the normal course of pregnancy. All pregnant women are monitored through laboratory and clinical data and the fetus monitored by tests that assessed their vitality, in addition, pregnant women in the intervention group performed the proposed physiotherapeutic the study protocol.

Eligibility Criteria:
Inclusion Criteria:

Participed of The study, high-risk pregnant women with gestational age between 24 and 38 weeks, hospitalized with a diagnosis of preeclampsia or chronic hypertension with superimposed preeclampsia, with no other maternal diseases and absence of fetal diseases by diagnostic ultrasound examinations and fetal well.

Exclusion Criteria:

* Pregnant women who became symptomatic (blurred vision, epigastric pain, headache) secondary to the hypertensive process;
* 24-hour proteinuria above 2 g
* Laboratory abnormalities (thrombocytopenia, alteration of renal function, elevated liver enzymes, elevated bilirubin);
* Request the patient to leave the project.
Effect of Probiotics on Patients With Congenital Heart Disease Following Cardiopulmonary Bypass

A randomized, controlled study including infants with non-cyanosis congenital heart disease (CHD) in need of surgical correction involving cardiopulmonary bypass (CPB) was established. Infants aged 1 month to 1 years were enrolled between June 2021 and July 2022. The patients in treatment group were supplied with probiotics consisting of Bifidobacterium infantis and Lactobacillus perioperatively and patients in control group were provided with placebo. Data concerning patients' clinical outcome such as diarrhea were collected. Blood samples were collected for measurement of fatty acid binding protein 2 (FABP2), diamine oxidase (DAO), d-lactic acid (D-LA) and C-reactive protein (CRP). Stool samples were collected to investigate the changes of intestinal flora.


Eligibility Criteria:
Inclusion Criteria:

* a diagnosis of CHD requiring surgical repair with the use of CPB
* age greater than 37 weeks corrected gestational age and less than 1 year old

Exclusion Criteria:

* Patients with inherited metabolic disease, history of intestinal surgery, preexisting gastrointestinal pathology (such as NEC, IBS, inflammatory bowel disease, chronic intestinal obstruction or diarrhea), immunity dysfunction or received antibiotics, probiotics or hormone-replacement therapy within 2 months before enrollment were excluded from the study