cyrilzakka/clinical-trials huggingface dataset:
Development, Intraoperative Demonstration and Visualization of Surgical Assistance Functions

The aim of the planned study is the development of surgical assistance functions on the basis of clinical routine data and the evaluation of the technical feasibility of an intraoperative demonstration and visualization of such assistance functions in visceral surgery. Furthermore, this trial aims to provide preliminary data on the clinical outcome of such assistance systems.

The aim of the clinical trial is to create the conditions for the comprehensive scientific use of new technologies such as augmented and virtual reality, computer-aided navigation and robotics in surgery in order to use these technologies in the future for improved surgical therapy for the benefit of the patient and to support the treating surgical team. The IDEMONSTRATE study is divided into two study parts: the development of a surgical assistance function based on routinely collected clinical (image) data that displays the position of anatomical structures (e.g. blood vessels, organs, tumors) in real time and the technical evaluation of this assistance system in the clinical environment.

For the development of the surgical assistance function, data routinely collected as part of surgical inpatient treatment will be used. For research purposes (and explicitly not to prepare for approval as a medical device), a surgical assistance function is to be developed from this that displays the position of anatomical structures in real time during visceral surgical interventions. This system will then be evaluated in the second part of the study with regard to its technical feasibility and medical relevance.

For the evaluation of the developed assistance function in the context of clinical treatment, the patients and the staff involved will be informed separately. All patients who are eligible for inclusion in the evaluating part of the study are fully capable of giving their consent. All doctors who will take part in the evaluation of the developed algorithm in a clinical context are specialists in general or visceral surgery; these doctors are informed in detail about the risks and sources of error in the context of the application before the developed algorithm and the associated assistance function is used. The evaluation of the developed assistance function takes place exclusively in the context of planned interventions, not in emergency situations.

Eligibility Criteria:
Inclusion Criteria:

* Indication for surgery using a laparoscopic or open surgical camera, a surgical robot (e.g., DaVinci system), or an intraoperative imaging modality (e.g. sonography, intraoperative CT)
* Patient understands German

Exclusion Criteria:

* Lack of ability to consent
Pearls and Pitfalls in Usage of Plasma-Rich Platelet Graft Versus Dartos Flap in Distal Penile Hypospadias Repair

Hypospadias is the most common congenital anomaly of penis. It is the second most common genital birth defect in boys after cryptorchidism The reinforcement of hypospadias repair with an intermediate layer is believed to reduce the incidence of postoperative complications such as uretherocautanous fistula.

Hypospadias is classified by the location of the abnormal urethral meatus into distal penile (glandular ,subcoronal and distal penile), mid penile and proximal penile hypospadias Indeed, uretherocautanous fistula is most common complication after urethroplasty, with introduction of a protective layer between the neourethra and the covering skin strongly reduces fistulas occurrence and the overall complication the aim of the study To evaluate and to compare the use of PRP covering layer and dartos fascia flap layer in regard to complication rates in hypospadias repair

Hypospadias is the most common congenital anomaly of penis. It is the second most common genital birth defect in boys after cryptorchidism The reinforcement of hypospadias repair with an intermediate layer is believed to reduce the incidence of postoperative complications such as uretherocautanous fistula.

Hypospadias is classified by the location of the abnormal urethral meatus into distal penile (glandular ,subcoronal and distal penile), mid penile and proximal penile hypospadias Indeed, uretherocautanous fistula is most common complication after urethroplasty, with introduction of a protective layer between the neourethra and the covering skin strongly reduces fistulas occurrence and the overall complication the aim of the study To evaluate and to compare the use of PRP covering layer and dartos fascia flap layer in regard to complication rates in hypospadias repair

Eligibility Criteria:
Inclusion Criteria:

* Age \>6 months
* Distal penile hypospadias
* Denovo hypospadias

Exclusion Criteria:

* Recurrent hypospadias -Mid and proximal penile hypospadias
Performance of Long-wavelength Autofluorescence Imaging

Fundus autofluorescence imaging has become an important diagnostic tool in ophthalmology, guiding diagnosis and assessment of progression of retinal diseases. This study investigates the performance of optimized long-wavelength autofluorescence imaging. To achieve this goal, the investigators will determine an optimal long wavelength excitation light and investigate the autofluorescence signal intensity in normals and patients with different retinal diseases. The diagnostic performance of the long-wavelength autofluorescence will be evaluated by assessing sensitivity and specificity for diagnosing a variety of degenerative retinal diseases and by comparing it to conventional autofluorescence.

Fundus autofluorescence (AF) imaging of the retina with confocal scanning laser ophthalmoscopy has been established as a non-invasive imaging modality for the diagnosis of retinal and macular diseases. Long-wavelength near-infrared autofluorescence (excitation: 787 nm, LW-AF) is a new, innovative alternative to the classic autofluorescence imaging using 488 nm blue excitation light. Excitation of the fluorophores at the ocular fundus using a longer wavelength has several advantages. However, with the current imaging technique the autofluorescence signal and thus image quality is considerably lower compared to conventional short-wavelength autofluorescence (SW-AF). This may be the main reason for the currently limited application and scarce scientific publications on this technique.

Therefore, the objective of this study is to assess the performance of an optimized setup of long-wavelength autofluorescence imaging in clinical routine applications. For this purpose, additional laser sources will be integrated into a scanning laser ophthalmoscope and the performance with regards to image quality will be investigated systematically using different excitation wavelengths and filter combinations in healthy controls.

In a next step, the signal intensity will be quantified using an integrated fluorescent reference. First, factors affecting measurements will be identified, followed by generation of a normative database. Subjects with various retinal diseases will then be investigated and compared to the normative database.

Finally, the diagnostic performance of long-wavelength autofluorescence imaging to detect retinal degenerative diseases will be investigated and compared to conventional imaging techniques.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 years or above
* Defined retinal disease (patients) or no known retinal disease (healthy participants)
* Participants willing to read and understand the study information and provide informed consent
* Participants agree to have some examinations and photographs taken from their eyes

Exclusion Criteria:

* Significant opacities of the ocular media
* difficulties positioning still in front of the camera
* any ocular/ general disease known to affect recordings and/or analysis of retinal images
* Pupil diameter \<5mm
Are There Differences Between Carriers of Haemophilia A and B?

This study aims to develop a systematic genetic screening strategy for (potential) female carriers of haemophilia by identifying as many female carriers as possible within the families of haemophilia patients regularly followed at Cliniques universitaires Saint-Luc (CUSL) and to search for differences between female carriers of haemophilia A (HA) and B (HB).

In order to complete our local registry of female carriers, the family trees of haemophilia patients will be systematically updated during their follow-up consultations at the haemophilia centre. Female carriers not yet known in our centre, identified by the updating of pedigrees, will be invited to present themselves in the haematology consultation and to participate in the study by means of an invitation and information letter which will be given/sent to them by the index haemophilia patient. Female carriers already known for whom missing data and/or the indication of regular follow-up have been identified during the file review will also be invited to attend a consultation within the framework of the study.

At these consultations, (potential) carriers will be given information about haemophilia, the mode of genetic transmission and the implications of carrier status on patients' lives (bleeding prevention, reproductive choices, current haemophilia treatments and future prospects). We will then determine the bleeding phenotype of each patient by taking a comprehensive bleeding history. With the consent of the participants concerned, the familial genetic variant responsible for haemophilia will be sought in them in order to definitively establish their carrier status. The basal level of coagulation factors VIII (HA)/IX (HB) will also be determined. If a deficiency is found, haemostatic treatment adapted to the patient's situation will be initiated and clinical follow-up outside the study recommended.

After completion of the data collection, the data will be analyzed and compared between HA and HB carriers in order to identify possible differences between these two populations.

Eligibility Criteria:
Inclusion Criteria:

- Family member affected by haemophilia A or B and potential/obligate carriership of HA/HB.

Exclusion Criteria:

* None.
A Study of Acalabrutinib in Combination With Rituximab Versus Ibrutinib Versus Acalabrutinib in Subjects With Relapsed or Refractory Mantle Cell Lymphoma

This study is evaluating the efficacy of acalabrutinib in combination with rituximab (Arm 1) versus ibrutinib (Arm 2) versus acalabrutinib (Arm 3) for the treatment of relapsed or refractory (R/R) mantle cell lymphoma (MCL).


Eligibility Criteria:
Inclusion Criteria:

* Men and women ≥ 18 years of age.
* Pathologically confirmed mantle cell lymphoma (MCL).
* Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2.
* Agreement to use highly effective forms of contraception during the study and for 90 days after the last dose of acalabrutinib or ibrutinib or 12 months after the last dose of rituximab (whichever is longest).
* Disease that has relapsed, or been refractory to, ≥ 1 prior treatment regimen for mantle cell lymphoma (MCL).
* Willing and able to participate in all required evaluations and procedures in this study protocol including swallowing capsules without difficulty.
* Ability to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use protected health information (in accordance with national and local patient privacy regulations).

Exclusion Criteria:

* Any history of central nervous system (CNS) lymphoma or leptomeningeal disease.
* Prior exposure to ibrutinib or to a B-cell receptor (BCR) inhibitor.
* Significant cardiovascular disease.
* Malabsorption syndrome, disease significantly affecting gastrointestinal function, or resection of the stomach or small bowel, symptomatic inflammatory bowel disease, partial or complete bowel obstruction, or gastric restrictions and bariatric surgery, such as gastric bypass.
* Uncontrolled active systemic fungal, bacterial, viral, or other infection.
* Known history of infection with human immunodeficiency virus (HIV).
* History of hepatitis B (HBV) infection or active infection with hepatitis C (HCV).
* Breastfeeding or pregnant.
Pilot Study to Evaluate the Safety and Efficacy of 5-ALA-SFC in Type II Diabetes

The aim of this pilot study is to assess the safety and preliminary efficacy of 5-ALA - SFC at doses up to 200 mg per day in subjects with type II diabetes.

The primary objective is to assess the safety of 5-ALA - SFC at doses up to 200 mg per day in subjects with type II diabetes mellitus. Safety will be assessed by the incidence of adverse events and clinically significant laboratory results.

The secondary objective is to assess the efficacy of 5-ALA-SFC at doses up to 200 mg per day on glycemic control in subjects with type II diabetes mellitus. Efficacy measures will include fasting plasma glucose level, HbA1c level, lipid profile, and body weight.

Eligibility Criteria:
Inclusion Criteria:

1. Males and females residing in Bahrain aged 20 to 75 years old
2. Otherwise in good health in the opinion of the investigator based on results of medical history, physical exam and laboratory assessments
3. Diagnosed with type II diabetes mellitus with HbA1c \>6.5 and \<10% which is uncontrolled despite the use of one or more glycemia-lowering drugs
4. BMI ≤44 kg/m2
5. Sitting BP ≤ 160/100mm Hg
6. Sleep apnea screening is negative
7. Ophthalmological exam is within normal limits as judged by the investigator. If findings are observed, they must be judged as not clinically significant.
8. Female subjects are not pregnant, not breast-feeding, and if of childbearing potential, have agreed to use an acceptable method of birth control

Exclusion Criteria:

1. Liver dysfunction defined as liver function tests \>1.5 times upper limit of normal
2. Renal dysfunction defined as BUN and/or serum creatinine \>1.5 times upper limit of normal and/or eGFR \<30 ml/min/1.73 m2
3. History of any life-threatening disease, cardiovascular disease, viral hepatitis, porphyria or hemochromatosis
4. Allergy to ALA, SFC, or any other component of study product
5. Use of insulin for management of serum glucose
6. Hypoglycemic event within the previous 3 months, defined as serum glucose levels less than 70 mg/dL
7. History of sickle cell anemia disease
Study To Evaluate Safety, Tolerability, And Pharmacokinetics Of PF-06473871 In Normal Healthy Adults

The purpose of the study is to evaluate the safety, tolerability, and pharmacokinetics of PF-06473871 in normal healthy adults.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male and/or females between the ages of 18 and 55 years inclusive

Exclusion Criteria:

* Currently pregnant
the Effectiveness of Different Risk Scales In Predicting VTE in Respiratory Inpatients

To compare the predictive effectiveness of the Caprini risk assessment model, the Padua risk assessment model and the VTE risk assessment in medical patients mentioned in the 2018 edition of the Guidelines for the diagnosis, treatment and prevention of pulmonary thromboembolism on the risk of concomitant VTE in respiratory inpatients to provide a basis for clinical VTE assessment and treatment.

A case-control study was used to collect patients who developed VTE during hospitalization in the Department of Respiratory Medicine at Peking University Third Hospital Hospital from January 2015 to December 2020 as the case group, and 2-fold patients who did not develop VTE matched to the case group (age, sex, ADL score, diagnosis, and length of hospitalization) as the control group. The general status of the patients was also assessed using the Padua risk model, the Caprini risk model, and the VTE risk assessment scale for medical patients mentioned in the 2018 edition of the Guidelines for the diagnosis, treatment, and prevention of pulmonary thromboembolism, and the relevant items involved in the assessment form were obtained by reviewing the cases.

Eligibility Criteria:
Inclusion Criteria:

* age more than 18y respiratory inpatient

Exclusion Criteria:

* Patients with deep vein thrombosis or pulmonary thromboembolism, sequelae of deep vein thrombosis, and thrombosis in other parts of lower limbs were diagnosed; Patients with severe coagulation dysfunction or other hematological diseases
Comparative Effects of ACBT and Slow Expiration in Patients With Chronic Obstructive Pulmonary Disease

Chronic obstructive pulmonary disease (COPD) is characterized by nonreversible airway obstruction. A diagnosis of COPD is determined by clinical assessment of airflow limitation and symptoms such as cough and wheeze; however, the detrimental effect of COPD symptoms on a patient's quality of life is often underestimated. Rehabilitation exercise can lessen the possibility of the progressive exacerbation of the patient's condition, exerting an active role in improving their lung function and the quality of the patients' life .Therefore, Active cycle breathing techniques (ACBT) is a cycle of techniques consisting of breathing control, lower thoracic expansion exercises and the forced expiration technique modifiable for every patient to reduce condition . The effect of ELTGOL on mucus clearance of right and left lungs, especially of peripheral lung areas, in stable patients with COPD . A couple of relaxed breaths and when you are ready go on to your huff. Repeat the huff two or three times until you have the urge to cough. Once you have cleared your chest have a few normal relaxed breaths and start the cycle over again with deep breaths and huffs.

A Randomized clinical trial, subjects with age group between 4O-70 years. In Group -A subjects (n=15) were treated with Active Cycle of Breathing Technique where Group-B subjects (n=15) received ELTGOL training . This study is to compare the effectiveness of ACBT and ELTGOL on improving the Quality Of Life and increasing Functional Capacity in subjects with COPD . Assessment will be done before and after intervention and result will be analyzed using statistical package for social sciences SPSS 20.


Eligibility Criteria:
Inclusion Criteria:

* Both genders (Male and Female)
* 40-70 years
* Diagnosed COPD according to GOLD classification
* Hemodynamically stable patient

Exclusion Criteria:

* Patient with other disorders like cardiac and respiratory disorders
* Carcinoma
* Lung surgery
* Neurological disorders
Neonatal Electrical Activity at Different Altitude Levels

In this study, the objective is to compare neonatal cerebral electrical activity within 3 days after birth across different altitude areas using amplitude-integrated electroencephalography (aEEG), and establish reference value for each altitude level.


Eligibility Criteria:
Inclusion Criteria:

1. Singleton term infants (gestational age between 37 0/7 and 41 6/7 weeks) born in the participating hospital.
2. Infants appear well as defined by normal vital signs (heart rate ranging from 110 to 180 beats/min, respiratory rate ranging from 30 to 60 breaths/min, temperature ranging from 36.5°C to 37.5°C), absence of signs of illness such as cyanosis, respiratory distress and heart murmur.
3. The mother is permanent residence of the current altitude level and live in the study area for the entire duration of pregnancy.

Exclusion Criteria:

1. Need for supplemental oxygen or assisted ventilation.
2. Any evidence of intrauterine distress such as meconium-stained amniotic fluid, Apgar score \<7 at 1 or 5 min.
3. Referred to neonatal intensive care unit or neonatology department for any reason other than observation.
4. With major congenital anomaly.
5. Probes cannot be properly placed due to scalp lesions or hematomas.
6. Reject or withdraw from the study.
Injectable Platelet Rich Fibrin With Collagen Matrix in Treatment of Multiple Gingival Recession.

This study is proposing the use of i-PRF clot as a scaffold for the XCM in order to obtain a novel biomaterial, incorporating active growth factors and collagen matrix in a single framework, based on the potential effect of i-PRF to enhance fibroblast activity and angiogenesis stimulation for treatment of multiple gingival recession.


Eligibility Criteria:
Inclusion Criteria:

* Presence of at least two localized gingival recessions on either sides of the maxilla and/or mandible excluding molar region.
* The cemento-enamel junction (CEJ) is visible in the teeth for root coverage procedures.
* All recessions are type 1recession RT1 (cairo et al,2011) which correspond to Miller I\&II gingival recession
* All patients must demonstrate adequate plaque control with a fullmouth plaque score less than 20% and with .
* All patients at least 18 years of age and of both genders.

Exclusion Criteria:

* Smoker Patients .
* Patients with diabetes.
* Patients with a history of malignancy, radiotherapy, or chemotherapy for malignancy.
* pregnant or nursing women.
* Patients taking medications or having treatments with an effect on mucosal healing in general (e.g. steroids, large doses of antiinflammatory drugs).
* Patients with a disease affecting connective tissue metabolism.
* Patients allergic to collagen.
Non-Invasive Chromosomal Evaluation of Trisomy Study

This study is being conducted to provide clinically annotated samples to support continued improvements in the Ariosa Test content, methodology, specimen processing and quality control.


Eligibility Criteria:
Inclusion Criteria:

* 1. Subject is at least 18 years old and can provide informed consent;
* 2. Subject has a viable singleton or twin pregnancy;
* 3. Subject is confirmed to be at least 10 weeks, 0 days gestation at the time of the study blood draw;
* 4. Subject is planning to undergo CVS and/or amniocentesis for the purpose of genetic analysis of the fetus OR the subject has already undergone CVS and/or amniocentesis and is known to have a fetus with a chromosomal abnormality confirmed by genetic analysis.

Exclusion Criteria:

* 1. Subject has known aneuploidy;
* 2. Subject is pregnant with more than two fetuses or has had sonographic evidence of three or more gestational sacs at any time during pregnancy;
* 3. Subject has a fetal demise (including natural or elective reduction) identified prior to consent;
* 4. Subject has history of malignancy treated with chemotherapy and/or major surgery, or bone marrow transplant;
Evolutive Potential of Embryos Obtained From Oocytes After Luteal Phase Ovarian Stimulation

The purpose of this study is to evaluate the clinical pregnancy rate per embryo transfer in oocytes recipients obtained after ovarian stimulation during the luteal phase of oocytes donors . This study will be performed in egg recipients and donors but this type of treatment is meant to be implemented in fertility preservation patients


Eligibility Criteria:
Inclusion Criteria:

* premenopausal women, 18-35 years old, FSH levels \< 10 mIU/ml; AFC\> 10
* regular cycles
* BMI \< 28
* signed informed consent

Recipients:

* Infertile women eligible for oocytes donation
* BMI \< 35
* Signed informed consent form

Exclusion Criteria:

-Polycystic ovarian syndrome, gonadotropins allergy

Recipients:

* Women eligible for oocytes donation
* BMI \>35
* Uncontrolled Endocrine Pathology