cyrilzakka/clinical-trials huggingface dataset:
Aswan Heart Centre - Egyptian Healthy Volunteers

To define the genotype of a healthy Egyptian cohort as a crucial step in determining the possible clinical implications of mutations detected in patients recruited in the registry.

A key objective of the existing Cardiomyopathies project is to develop and validate assays to identify the genetic and molecular determinants of inherited cardiomyopathies in the Egyptian population.

Current sequencing technology has made cost- and time-effective whole exome and whole genome sequencing feasible. In their attempt to make clinically-relevant conclusions, genetecists, clinicians and bioinformaticians are increasingly faced by thousands of polymorphisms and variants, the clinical significance of which requires careful and systematic analysis of a number of factors including location of the mutation within the genome, type of mutation, gene affected and the protein for which it codes, functional importance of the coded protein, segregation within the family as well as frequency of the detected variation in the same population.

The latter step requires defining what constitutes the "genetic norm" (including normal variants) within the reference population. Data for different populations is already available in a number of databases that are accessible to the scientific community to help maximize the public benefit from research. Examples include the Exome Aggregation Consortium (ExAC) - which aggregates exome sequencing data from 60,706 unrelated individuals - and the 1000 Genomes Project which aggregates whole genome sequencing data from 2500 individuals.

However, to be able to confirm novel gene variants in the Egyptian population, data has to be compared to genomes of healthy individuals in the same population.

Eligibility Criteria:
* Inclusion Criteria:

  * Any adult Egyptian citizen subject that considers him/herself free of cardiovascular disease.
* Exclusion Criteria:

  * Individuals under 18 years of age
  * Known cardiovascular disease
  * Known collagen vascular disease
  * Individuals with communication difficulties, or who do not wish to participate
  * Pregnancy
  * Contraindication to MRI
  * Family history of sudden death
  * Family history of a familial cardiomyopathy
  * Family history of premature coronary artery disease (males \<40 years, females \<50 years).
* Withdrawal Criteria:

  * Withdrawal of consent.
Postoperative Anemia and Functional Outcomes After Fast-track Primary Hip Arthroplasty

The purpose of this study is to evaluate the possible association between postoperative anaemia and functional outcomes the first 2 weeks after primary hip arthroplasty.

The investigators hypothesise that patients with a higher degree of postoperative anaemia have impaired postoperative rehabilitation as measured by standardized functional outcome tests.

Postoperative anemia may impair postoperative rehabilitation due to anemia related symptoms such as fatigue or dizziness. Although, the impact of postoperative anemia on postoperative rehabilitation and function has previously been examined the results are conflicting.

Patients undergoing fast-track hip arthroplasty (THA) are mobilized early and participate in physiotherapy during the admission but are discharged early (2-3) days postoperative. However, the ability to rehabilitate early after discharge has not been evaluated in relation to postoperative anemia.

The purpose of this observational study is to evaluate the possible association between postoperative anaemia and functional outcomes the first 2 weeks after primary hip arthroplasty.

The investigators hypothesise that patients with a higher degree of postoperative anaemia have impaired postoperative rehabilitation as measured by standardized functional outcome tests. Hb concentrations and functional outcome measurements will be performed preoperatively, at the day of hospital discharge and during a postoperative visit 12-16 days after surgery.

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing primary unilateral THA
* Age 65 or older

Exclusion Criteria:

* Not able to give consent
* Not able to walk prior to surgery
* Chronic need for RBC transfusion
PrOgnostic Implications of PRe-stent Pullback Pressure GradIent and Post-stent Quantitative Flow Ratio in Patients UnderGoing Percutaneous Coronary INtervention

The purpose of this study is to investigate the prognostic implication of pre-percutaneous coronary intervention (PCI) focal or diffuse disease patterns combined with post-PCI quantitative flow ratio (QFR).

Coronary diffuse disease associates with poor outcomes, but little is known about whether this prognostic value retains after PCI, especially in those with good post-PCI physiologic results.

QFR can provide the virtual pullback curve by depicting pressure at each point along the interrogated vessel, which can be used to calculate the pullback pressure gradient (PPG) index, this index has been shown to be able to suggest the physiological plaque distribution and to discriminate focal from diffuse disease. Absolute quantification of coronary diffuseness makes it possible to evaluate the prognostic value of baseline coronary diffuseness before stent implantation, which is rarely investigated till now.

The CHART-ORIGIN study aims to investigate the independent and additive prognostic implications of pre-PCI functional disease patterns assessed by PPG with post-PCI QFR in vessels with stent implantation.

Eligibility Criteria:
Inclusion Criteria:

* Patients with at least one vessel with measurable QFR
* PPG index can be calculated from virtual QFR pullback curve;
* The patient is willing to comply with specified follow-up evaluations;
* Patients who agree to accept the follow-up visits.

Exclusion Criteria:

* Culprit vessels for ACS myocardial infarction;
* Pregnant or nursing patients and those who plan pregnancy in the period up to 1 year following index procedure;
* Patient has other medical illness (e.g., cancer, known malignancy, congestive heart failure, organ transplant recipient or candidate) or known history of substance abuse (alcohol, cocaine, heroin etc.) that may cause non-compliance with the protocol, confound the data interpretation or is associated with a limited life expectancy (i.e., less than 1 year);
* Patient has a known hypersensitivity or contraindication to aspirin, heparin, clopidogrel/ticlopidine, stainless steel alloy, cobalt chromium, rapamycin, styrene-butylenes-styrene or poly-lactic acid (PLA) polymer, and/or contrast sensitivity that cannot be adequately pre-medicated;
* Any significant medical condition which in the Investigator's opinion may interfere with the patient's optimal participation in the study;
* Currently participating in another investigational drug or device study or patient in inclusion in another investigational drug or device study during follow-up.
Irreversible Electroporation(IRE) For Unresectable Renal Pelvic and Ureteral Neoplasms

The purpose of this study is to evaluate the safety and efficacy of irreversible electroporation (IRE) for unresectable Renal Pelvic and Ureteral Neoplasms.

By enrolling patients with unresectable Renal Pelvic and Ureteral Neoplasms adapted to enrolled criteria, this study will document for the first time the safety and the short and long term efficacy of percutaneous IRE for unresectable Renal Pelvic and Ureteral Neoplasms.

Eligibility Criteria:
Inclusion Criteria:

* Renal Pelvic and Ureteral Neoplasms diagnosed by positive biopsy or non-invasive criteria,
* Not suitable for surgical resection,
* Eastern Cooperative Oncology Group (ECOG) score of 0-1,
* A prothrombin time ratio \> 50%,
* Platelet count \> 80x10\^9/L,
* Ability of patient to stop anticoagulant and anti-platelet therapy for seven days prior to and seven days post NanoKnife procedure,
* Able to comprehend and willing to sign the written informed consent form (ICF),
* Have a life expectancy of at least 3 months.

Exclusion Criteria:

* Cardiac insufficiency, ongoing coronary artery disease or arrhythmia,
* Any active implanted device (eg Pacemaker),
* Women who are pregnant or women of child-bearing potential who are not using an acceptable method of contraception,
* Have received treatment with an investigational agent/ procedure within 30 days prior to treatment with the NanoKnife™ LEDC System,
* Are in the opinion of the Investigator unable to comply with the visit schedule and protocol evaluations.
Prophylactic Radiotherapy of MInimally Symptomatic Spinal Disease

Early palliative care has been shown to improve the quality of life and even survival for patients with metastatic cancer. More and more supportive oncology teams in cancer centers now advocate for early integration of radiation therapy (RT) in a patient's palliative management course. While multiple randomized studies have evaluated the efficacy of different RT regimens in the treatment of symptomatic bone lesions, few studies have examined the impact of early, upfront RT for asymptomatic or minimally symptomatic (non- opioid dependent) spine metastases and its efficacy in preventing skeletal-related events (SREs). Since the pathophysiology of spinal metastatic disease is distinct from other bony metastatic disease, the proposed trial seeks to understand whether it is beneficial to patients with minimally symptomatic disease to undergo upfront RT to reduce the risks of SREs and their sequelae, including hospitalizations.


Eligibility Criteria:
Inclusion Criteria:

1. Histologically-confirmed solid tumor malignancy with greater than 5 sites of metastatic disease detected on cross-sectional imaging.
2. Has high-risk bone metastases that are asymptomatic or minimally symptomatic (not requiring opioids). High risk metastases are defined as:

   1. Bulkiest sites of spinal osseous disease ≥ 2cm,
   2. Disease at junctional levels, including the thoracic apex (Occiput to C2, C7-T1, T12-L2, and L5- S1)
   3. Disease with posterior element involvement, including interspinous, unilateral, or bilateral facet joints.
   4. Vertebral body compression deformity \> 50%.
3. Eastern Cooperative Oncology Group (ECOG) performance status 0 - 2.
4. Age ≥ 18 years.
5. Able to provide informed consent.
6. Patients at reproductive potential must agree to practice an effective contraceptive method. Women of childbearing potential must not be pregnant or lactating.

Exclusion Criteria:

1. Previous RT to the intended treatment site that precludes developing a treatment plan that respects normal tissue tolerances.
2. Serious medical co-morbidities precluding RT.
3. Pregnant or lactating women.
4. Target lesion(s) is/are complicated bone metastases that include clinical or radiological evidence of spinal cord compression or impending pathological fracture.
5. Leptomeningeal disease.
6. Patients whose entry to the trial will cause unacceptable clinical delays in their planned management.
An Observational Study of Olanzapine Coated and Orodispersible Tablets Effectiveness in Schizophrenic and Bipolar Outpatients.

The primary objective of this study is to assess the proportion of schizophrenic patients and the proportion of bipolar patients who discontinue olanzapine within 12 months of treatment in outpatient, ambulatory or community settings


Eligibility Criteria:
Inclusion Criteria:

* patients suffering from schizophrenic or schizoaffective disorders based on the disease diagnostic criteria DSM IV and being prescribed olanzapine during the 45 preceding days.
* patients suffering from bipolar disorders based on the disease diagnostic criteria DSM IV and being prescribed olanzapine during the 45 preceding days for one of the following:
* moderate or severe manic episode
* relapse prevention in patients with bipolar disorder

Exclusion Criteria:

* current treatment with any investigational drug or procedure at entry or during the whole study
* hypersensitivity to olanzapine
* patients with known narrow angle glaucoma risk
A Study to Assess Adverse Events and Disease Activity With Cedirogant (ABBV-157) in Adult Participants With Moderate to Severe Psoriasis

Psoriasis is a chronic disease characterized by marked inflammation and thickening of the skin that results in thick, scaly skin plaques. This study assessed how safe and effective cedirogant (ABBV-157) was compared to placebo in adult participants with moderate to severe psoriasis. Efficacy and safety-related measurements assessed disease activity in participants with plaque psoriasis.

Cedirogant (ABBV-157) is an investigational drug being developed for the treatment of chronic plaque psoriasis. Participants were put into 1 of 4 groups, called treatment arms and each group received a different treatment. There was a 1 in 4 chance that participants were assigned to placebo.

Participants received oral daily doses of cedirogant or placebo capsules for 16 weeks.

There may have been a higher burden for participants in this study compared to usual standard of care. Participants attended regular visits per routine clinical practice. The effect of the treatment was checked by medical assessments, checking for side effects, and questionnaires.


Eligibility Criteria:
Inclusion Criteria:

- Participants with stable moderate to severe plaque psoriasis of at least 6 months duration and who are candidates for systemic therapy or phototherapy.

Exclusion Criteria:

* Primary non-responders to previous anti-interleukin (IL)-17 (e.g., secukinumab, ixekizumab, brodalumab), anti-IL-23 (e.g., guselkumab, tildrakizumab, risankizumab), or anti-IL-12/23 (e.g., ustekinumab) treatment for chronic plaque psoriasis.
* Diagnosis of erythrodermic psoriasis, generalized or localized pustular psoriasis, medication-induced or medication exacerbated psoriasis, or new onset guttate psoriasis or any other skin disease which may interfere with assessment of chronic plaque psoriasis.
Data Collection for Motor Function and Gait Pattern Analysis of Patients With Chronic Stroke

In chronic stroke patients, the data for motor function and gait pattern analysis was obtained.


Eligibility Criteria:
Inclusion Criteria:

* Stroke patients with hemiplegia over 19 years old
* Ischemic or hemorrhagic stroke patients over 6 months of onset
* Functional Ambulation Category Scale with 3 or more scales and a person who can walk independently regardless of using of walking aids
* A person who understands and voluntarily participates in this study and signs a research agreement

Exclusion Criteria:

* Patients of artificial heartbeat
* Patients with claustrophobia
* Patients with intracranial metal implants
* Patients who are contraindicated for other common MRI scans
* Patients difficult to walk due to problems such as visual field defect, fracture, severe muscle paralysis, cognitive impairment
* Those who have a score of FMA score of 80 or more and have very slight motor impairment
To Study the Effects of Aliskiren on Albuminuria and Various Biomarkers in Patients With Nephropathy

The study is designed to primarily assess the effect of aliskiren on albuminuria in patients with non-diabetic nephropathy when treated with ramipril and volume intervention.


Eligibility Criteria:
Inclusion Criteria:

* Male and female subjects, age 18 years and above
* Patients with chronic kidney disease of non-diabetic origin
* Glomerular filtration rate \>30 ml/min/1.73m2
* Patients with a history of hypertension and msSBP (mean systolic blood pressure) of \<160 mm Hg and msDBP (mean diastolic blood pressure) \<105 mm Hg at screening and baseline.
* Subjects must have a body mass index (BMI) within the range of 18 and 35 kg/m2

Exclusion Criteria:

* Previously treated (within 3 months of screening) with aliskiren or a combination of aliskiren and ramipril.
* Severe hypertension (msDBP ≥110 mmHg and msSBP ≥180 mmHg)
* Pregnant or nursing (lactating) women,
* A medical history of unstable coronary artery disease, myocardial infarction, coronary bypass surgery or cerebrovascular accident within the last six (6) months
* Diabetes mellitus, Heart failure
* High rate of renal function loss
* History of severe hypersensitivity or contraindications to any of the medications or drugs belonging to the similar therapeutic class as the study drugs and the excipients.
* History of liver disease, positive Hepatitis B surface antigen (HBsAg) or Hepatitis C test result
* History of immunodeficiency diseases, including a positive HIV (ELISA and Western blot) test result.

Other protocol-defined inclusion/exclusion criteria applied
A Comparative Clinical and Radiographic Study Of Collagen Based Pulpotomy in Cariously Exposed Vital Primary Molars

To assess post operative pain and survival rate after collagen based pulpotomy versus MTA pulpotomy in children with vital primary molars.

Pulpotomy of vital primary molars is indicated when caries removal results in pulp exposure. Treatment approaches consist of devitalization using formocresol, preservation using ferric sulfate and regeneration using mineral trioxide aggregate of the remaining pulp tissue have been utilized to date. The ideal pulpotomy medicament would be biocompatible and bactericidal, in addition, to promote the healing of the root pulp and be compatible with the physiological process of root resorption.

Collagen, which is available for dental implication, is already sterilized and also reinforced with antibiotic particles to efficiently aid in regeneration and repair without any contaminations. The collagen particles can be sterilized by various methods like irradiation, dry heat, and ethylene oxide, among which irradiation is the most frequently used method as it does not affect the structural stability

Eligibility Criteria:
Inclusion Criteria:

1. Primary molar tooth not more than one-third of root resorption.
2. Children with bilateral deep dental caries approximating the pulp in primary molars assessed both clinically and radiographically.
3. systemically healthy.
4. cooperative patients who will comply to follow up visits.

Exclusion Criteria:

1. Children with medical, physical, or mental conditions.
2. Primary molars with any congenital deformities.
3. Previously accessed teeth.
4. At operative procedure haemorrhage control is unachievable after pulpotomy.
Intervention With Vitamin D and Omega-3 Supplements and Incident Heart Failure

This study will examine whether an intervention with vitamin D or fish oil supplements can reduce the risk of heart failure among adult men and women during a follow up period of up to five years (starting from the time of randomization into the parent VITAL trial). The investigators hypotheses are that both vitamin D and fish oil supplements will each reduce the risk of heart failure.

For this ancillary study of the ongoing parent VITAL trial, we will adjudicate incident heart failure cases occurring during a time period of up to five years starting from randomization of subjects in the parent VITAL study. Intention-to-treat analysis will be used to assess the efficacy of vitamin D as well as omega-3 fatty acids.

Eligibility Criteria:
Inclusion Criteria:

* Men aged 50 or older or women aged 55 or older
* Be consuming no more than 800 IU of vitamin D from all supplemental sources combined (individual vitamin D supplements, calcium+vitamin D supplements, medications with vitamin D \[e.g., Fosamax Plus D\], and multivitamins), or, if taking, willing to decrease or forego such use during the trial;
* Be consuming no more than 1200 mg/d of calcium from all supplemental sources combined, or, if taking, willing to decrease or forego such use during the trial;
* Not be taking fish oil supplements, or, if taking, willing to forego their use during the trial

Exclusion Criteria:

* prevalent heart failure
* History of cancer (except non-melanoma skin cancer), heart attack, stroke, transient ischemic attack, angina pectoris, CABG, or PCI
* History of renal failure or dialysis, hypercalcemia, hypo- or hyperparathyroidism, severe liver disease (cirrhosis), or sarcoidosis or other granulomatous diseases such as active chronic tuberculosis or Wegener's granulomatosis;
* Allergy to fish or soy
Assessment of Early Pancreatic Cancer Prognosis by Minimal Residual Disease Using Multi-omics Approach

This trial aims to develop a minimal residual disease (MRD) detection model for predicting recurrence of patients with stage I-II pancreatic ductal adenocarcinoma after surgery and adjuvant therapy, based on cfDNA fragmentation and methylation signal.

The entire study is divided into two stages. Stage one is the enrollment period. 51 subjects with pancreatic ductal adenocarcinoma in stages I-II who have not received neoadjuvant therapy and have undergone radical surgery were enrolled. Blood samples at the time point before surgical treatment (T0) were collected and fresh tissue specimens (cancerous tissue and adjacent normal tissue) were collected. Blood samples were subjected to methylation, fragment group, and CNV multi-omics testing, and tissue samples were subjected to target methylation area testing. Stage two is the follow-up period. Blood samples from the fifth week after surgery to before adjuvant therapy (T1) and blood samples from 4-8 weeks after adjuvant therapy (T2) were collected. Blood samples were subjected to methylation, fragment group, and CNV multi-omics testing with different techniques. The subjects were followed up for 1.5 years. According to progression and recurrence, the subjects were divided into progression group and non-progression group. Methylation and multi-omics prognosis models were trained and compared for their performance in residual detection and recurrence prediction.

Eligibility Criteria:
Inclusion criteria:

1. Patients with clinically and/or pathologically diagnosis of stage I/II pancreatic ductal adenocarcinoma;
2. Aged ≥ 40 years and \< 75 years, both sexes;
3. Patients receive radical resection with curative intent, followed by adjuvant therapy;
4. Tumour size not less than 1 cm \* 1 cm \* 1 cm and be able to provide surgical tissue samples for molecular testing after pathological evaluation;
5. Eastern Cooperative Oncology Group (ECOG) score of 0-2;
6. Negative margins (R0 or R1) by naked eye or no recurrence/metastasis detected on imaging after surgery or before adjuvant therapy, and CA 19-9\<37 U/ml;
7. Patients understand and voluntarily sign the informed consent form and follow the sampling, assessment and visit requirements of this study.

Exclusion criteria:

1. Pregnant and lactating (by self-report);
2. Any tumor history of malignancies;
3. Positive cutting margins (R2);
4. Received neoadjuvant therapy before surgery;
5. Not be able to receive radical surgery;
6. Organ transplantation history;
7. Organ dysfunction (moderate or severe renal impairment with absolute centrocyte count \< 1.0 x 10\^9/L, platelet count \< 75 x 10\^9/L, haemoglobin \< 80 g/L, AST/ALT \> 2.5 times upper limit of normal);
8. Other conditions deemed unsuitable for enrollment by the investigator.