cyrilzakka/clinical-trials huggingface dataset:
Retrospective Observational Study of Implant-supported Restorations With Dental Implants.

This retrospective study aims to value the bone loss and the success and survival of the dental implants produced by additive manufacturing installed in an area grafted with Plenum® Osshp (synthetic bone graft). In addition, the biological and biomechanical performance of implant restorations supported through an observational retrospective solution will be observed. From 50 to 100 survey participants will be selected, who will be invited to attend the clinic for clinical, radiographic, and prosthetic evaluation and successful parameters between baseline, 3, 6, and 12 months. The data obtained regarding bone loss (primary outcome) of the analyzed regions and implant success and survival in area grafted with Plenum® Osshp (secondary outcome) will be evaluated by the paired t-test for the evaluation of the times (3, 6, and 12 months) and survival curves of the installed dental implants.


Eligibility Criteria:
Inclusion Criteria:

Clinical parameters:

* Presence or absence of pain or tenderness
* Presence or absence of suppuration or exudation
* Presence or absence of mobility

Prosthetic parameters

- Presence or absence of mechanical complications (problems in prefabricated components such as screws and abutments).

Radiographic Parameters

* Presence or absence of peri-implant radiolucidity.
* maintenance and quality of the bone graft volume in the grafted area to each clinical indication: ridge augmentation, extraction sites (socket preservation or dental implant preparation/placement) and sinus lifting.
* Distance between the shoulder of the implant and the first visible bone contact (in mm).
* Presence or absence of technical complications such as fracture or loss of porcelain structures.

Success Parameters

* Absence of pain or tenderness.
* Absence of suppuration or exudation.
* Clinical absence of implant mobility.
* Absence of peri-implant radiolucency.
* Minor loss of up to 1.5mm in the first year of function.
* Absence of mechanical or technical complications in the dental implant and in the prosthesis to the dental implants installed in an area grafted.

Exclusion Criteria:

* N/A
A Difference in Subclavian Vein Catheterization Between Supine and Lateral Tilt Position - Stage II

Central venous catheterization is widely used for various purposes during surgery. For central venous catheterization, subclavian vein is selected because of the relatively low risk of infection, long-term patency and low patient discomfort. The cross - sectional area of the subclavian vein is an important factor to increase success rate. Several studies have reported that the Trendelenburg position increases the cross-sectional area of the subclavian vein, and the lateral tilt position can change the cross-sectional area of the subclavian vein. However, the impact of lateral tilt position to the cross-sectional area of the subclavian vein is not clear. The ipsilateral position can increase the cross-sectional area of the subclavian vein, and the contralateral position can decrease the cross-sectional area by gravity.

In the second stage of this study, the investigators would like to compare the success rate, the number of needle passage, time to complete subclavian vein catheterization in supine and ipsilateral tile position.


Eligibility Criteria:
Inclusion Criteria:

- the patients who receive elective neurosurgical surgery and require central venous catheter

Exclusion Criteria:

* the patients who have puncture site infection
* the patients who have chemoport, pacemaker in right subclavian vein
* the patients who had received right mastectomy or right pneumonectomy
* other contraindications for subclavian venous catheterization (eg. mass, hematoma, vegetation, and anticoagulation)
Effect of Cannabis and Cigarette Smoking on Oral Mucosa

The aim of this study is to detect P53 expression in clinically normal oral mucosa of cigarette smokers, simultaneous cigarette and cannabis smokers and non-smokers as a surrogate marker for field cancerization.

Roles and Responsibilities:

1. Ali Abd El Wahed Abd El Fatah Kotb (A.K.) operator, data enterer, Assistant lecturer, Oral and Maxillofacial Pathology, Faculty of Oral and Dental Medicine, Cairo university, Egypt.
2. Professor Dr. Heba Dahmoush (H.D.) main supervisor, data monitoring,auditing professor, Oral and Maxillofacial Pathology, Faculty of Oral and Dental Medicine, Cairo university, Egypt.
3. Eman Desoky (E.D.) sample size calculation, statistician,Faculty of Oral and Dental Medicine, Cairo University, Egypt.
4. Evidence Based Dentistry Committee (CEBD)help in reporting study protocol following SPIRIT guidelines,Faculty of Oral and Dental Medicine, Cairo University, Egypt.
5. Research Ethics Comittee (CREC)protocol reviewer in order to protect the right, safety, dignity and well-being of the participants, Faculty of Oral and Dental Medicine, Cairo University, Egypt.

1- Intervention: A.K. will collect specimens from cigarette smokers and simultaneous cigarette and cannabis smokers. then the expression of p53 as a marker for field cancerization will be investigated in formaline fixed paraffine embedded specimens of mucosal biopsies obtained from the oral mucosa of both groups.

2-comparator: mucosal biopsies from non smokers will be investigated as a copmaratitive to smokers group.

Eligibility Criteria:
Inclusion Criteria:

* frequent smokers (at least 10 cigarettes a day) for a period not less than 5 years.
* Simultaneous smokers to be included in the study must be frequent cigarette smokers (at least 10 cigarettes a day) for a period not less than 5 years plus frequent cannabis smoker (at least 3 times per week) for a period not less than 5 years.

Exclusion Criteria:

* Exposure to other carcinogens.
* un-clear smoking history.
* medically compromised patients
Study of Efficacy and Safety of Brolucizumab Versus Panretinal Photocoagulation Laser in Patients With Proliferative Diabetic Retinopathy

The purpose of this study is to evaluate the efficacy and safety of brolucizumab compared to panretinal photocoagulation laser (PRP) in patients with proliferative diabetic retinopathy (PDR). This evaluation will provide information that brolucizumab is non-inferior to PRP with respect to the change in best corrected visual acuity at Week 54.

The study is an ongoing, Phase III, 96-week, two-arm, randomized (1:1 ratio), single-masked, multi-center, active-controlled study to evaluate the efficacy and safety of brolucizumab compared to Panretinal photocoagulation (PRP) in subjects with Proliferative diabetic retinopathy (PDR). Subjects who met all the inclusion and none of the exclusion criteria were randomized in a 1:1 ratio to one of the following treatments:

* Brolucizumab 6 mg: 3 x q6w loading then q12w maintenance through Week 90, with the option from Week 48 onwards to extend the treatment interval by 6 weeks at a time up to 24 weeks and revert to q12w if disease worsens. More frequent injection with q6w interval in the maintenance phase could be administered at the discretion of the Investigator if the disease worsens.
* PRP: initial treatment in 1-4 sessions up to Week 12, followed with additional PRP treatment (may split into 2-4 sessions) as needed up to Week 90. Visits occurred every 6 weeks throughout the study, regardless of treatment or not.

Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent must be obtained prior to participation
* Able to complete adequate fundus photographs and retinal images
* Diagnosis of type 1 or 2 Diabetes Mellitus (DM) and HbA1c less than or equal to 12% at screening
* DM treatment stable for at least 3 months
* PDR diagnosis with no previous PRP treatment in the study eye

Exclusion Criteria:

* Concomitant conditions or ocular disorders in the study eye at Screening or Baseline that could compromise a response to study treatment.
* Presence of diabetic macular edema in the study eye
* Active infection or inflammation in the study eye
* Uncontrolled glaucoma (IOP greater than 25 mmHg)
* Intravitreal anti-VEGF treatment within 6 months
* Treatment with intraocular corticosteroids
* End stage renal disease requiring dialysis or kidney transplant
* Uncontrolled blood pressure
* Systemic anti-VEGF therapy at any time

Other protocol-defined inclusion/exclusion criteria may apply.
Effects of Sub Occipital Muscle Inhibition Technique in Mechanical Low Back Pain

The aim of study is to determine the effects of sub occipital muscle inhibition technique in mechanical low back pain, hamstring muscle flexibility, lumbar ranges and functional disability. This study will focus on either this technique have effects on reliving lumbar pain, improving flexibility of hamstring muscles and lumbar ranges or not.

Low back pain (LBP) is a common health condition, 70% of population of all ages is suffering from low back pain. Females have higher prevalence of low back pain than males. Individuals with low back pain experience muscle stiffness tension and pain in the back of body between the lower edge of 12th rib and the lower border of gluteal creases in the lumbo-sacral area (from L1-S1 vertebra) with a duration of more than three months. Low back pain can be mechanical in nature and is not associated with any other pathology .The primary etiological factors of mechanical low back pain is repetitive trauma and overuse.

Hamstring is a multi - joint muscle complex which consists of three muscles ( semitendinosus, semimembranosus and biceps femoris muscle) that covers the posterior thigh extending from ischial tuberosity to the medial and lateral aspects of the knee joint, performing flexion of knee and extension of hip joint. Hamstring muscle is prone to tightness, its flexibility have a vital role in maintaining the normal lumbar spine mechanics. Hamstring tightness is common among ages of 18-25 years with about 62% to 82% prevalence .Hamstring shortening during spinal flexion limits anterior pelvic tilting resulting in higher compressive loads on lumbar spine. It will place extreme pressure on lumbar extensors, involved in maintaining pelvic motion which will result in LBP .

Sub occipital muscle inhibition technique is a technique that results in relaxing the tense fascia and sub occipital muscles .It can be relaxed by applying pressure to sub occipital region while patient is lying in supine position. It is able to relax the fascia and results in increasing hamstring flexibility, which further results in reducing low back pain, increasing lumbar spine mobility and reducing functional limitations

Eligibility Criteria:
Inclusion Criteria:

* Chronic mechanical low back pain \> 12 weeks
* Patients with hamstring tightness having popliteal angle more than 30 degrees.
* Negative sacroiliac distraction test to exclude sacroiliac joint pain

Exclusion Criteria:

* Acute severe low back pain
* Patients with hamstring injury
* Active tumor or infection
* Fractures of cervical and lumbar spine
* History of previous lumbar, hip and knee surgery
* Migraine
* Fever
* Sacroiliac joint dysfunction
* Cauda equine syndrome
* Patients having cognitive or mental retardation
Staple-line Reinforcement for Prevention of Pulmonary Air Leakage

The aim of this study is to compare the efficacy of FORESEAL with stapling alone or associated with tissue sealant or glue in terms of air leakage duration after lung resection for cancer.

Hypothesis: to show a significant difference of 1 day in the average duration of air leakage between the 2 groups with a standard deviation of 3 (α =0.05 and β=0.10).

Air leaks continue to be the most common complication after pulmonary resection even using a stapling device. Double chest tubes after lobectomy is a well established method for drainage of the pleural cavity to allow adequate expansion of the remaining lung.

FORESEAL has been developed to reduce air leaks by buttressing the staple line. It is a absorbable vegetal biopolymer in the form of sleeves, CE marked and indicated for prevention of air leakage after pulmonary resection with stapling device. It acts as a suture reinforcement as well as a sealant thanks to its jellification.

Sealants are also commonly used in addition to stapling to prevent air leakage. The aim of this study is to compare the efficacy of FORESEAL with stapling alone or associated with sealants.

This is a multi centre, prospective controlled and randomised clinical study.

Eligibility Criteria:
Inclusion Criteria:

* Patient 18 years old or over.
* Patient that undergoes a lobectomy or bilobectomy for lung cancer,
* Patient presenting an incomplete fissure, requiring stapling of at least 50% of the fissure and/or an emphysematous lung at the fissure point, requiring stapling.
* Patient that has signed the informed consent before the operation.
* Patient that benefits from a social security regime.

Exclusion Criteria:

* Patient with history of thoracotomy on the side operated on.
* Patient with severe pleural infection and/or infection of parenchyma.
* Presence of air leakage after liberation of lung in cases of pleural symphysis.
* Patient pregnant, giving birth or nursing.
* Patient presenting a contra indication to the aerostatic products used.
* Patient already participating in biomedical research.
Mild Traumatic Brain Injuries in Children: Predicting Behavioral and Emotional Deficits

The purpose of this study is to investigate the role of psychosocial factors in creating Persistent Post-concussive symptoms (PPCS). The researchers investigate three hypotheses: (a) Do pre-injury psycho-environmental deficits predict a higher level of PPCS? (b) Do socio-demographic and personal pre-injury deficits relate to (1) a more negative attribution for the child injury by their parents and (2) embracing of a more permissive and authoritarian parenting; and do these factors mediate the symptoms' preservation? (c) Does Cognitive-Behavioral Therapy (CBT) benefit to reducing PPCS emotional and behavioral symptoms?

200 children and adolescents with post concussion will be followed for 9 months, since the time of the head injury. Post concussive symptoms, along emotional distress and neurocognitive deficits will be examined at 2 weeks, 4 months and 9 months since the injury, using self report questionnaires, psychological evaluation and neuropsychological tests. Participants who demonstrates PPCS 4 months after the injury will be assigned either to the Cognitive Behavioral Treatmet group (CBT) or to the Treatment as Ususal group(TAU). The change in symptoms severity (PCS, emotional distress and neurocognitive deficits) will be compared between the two study groups in order to assess treatment efficacy.

Eligibility Criteria:
Inclusion Criteria:

* Head trauma.
* Post-concussive symptoms diagnosis according to DSMIV.

Exclusion Criteria:

* mental retardation.
* drug abuse.
A Phase 2, Randomized, Double Blind, Placebo Controlled Study of AMG 386 in Combination With FOLFIRI in Subjects With Previously Treated Metastatic Colorectal Carcinoma

This clinical trial will compare the efficacy and safety of the combination of AMG 386 and FOLFIRI with FOLFIRI alone in second line treatment of metastatic colorectal cancer.


Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed adenocarcinoma of the colon or rectum in patients who are presenting with metastatic disease
* One and only one prior chemotherapy regimen for metastatic disease consisting of the combination of a fluoropyrimidine-based chemotherapy and an oxaliplatin-based chemotherapy. Prior adjuvant chemotherapy used prior to the onset of metastatic disease is permitted
* At least one uni dimensionally measurable lesion per modified RECIST criteria. All sites of disease must be evaluated \<= 28 days before randomization
* Radiographically documented disease progression per modified RECIST criteria either while receiving or \<= 6 months after the last dose of prior chemotherapy regimen for metastatic disease
* ECOG performance status of 0 or 1
* Man or woman \>= 18 years of age
* Adequate end organ assessments by laboratory studies (hematological and chemistries)
* Life expectancy \>= 3 months

Exclusion Criteria:

* Exclude subjects with a history of prior malignancy, except:

  * Malignancy treated with curative intent and with no known active disease present for \>= 3 years before enrollment and felt to be at low risk for recurrence by treating physician
  * Adequately treated non-melanomatous skin cancer or lentigo maligna without evidence of disease
  * Adequately treated cervical carcinoma in situ without evidence of disease
  * Prostatic intraepithelial neoplasia without evidence of prostate cancer
* Prior irinotecan therapy
* Systemic chemotherapy, hormonal therapy, or immunotherapy \<= 21 days prior to randomization
* Experimental or approved proteins/antibodies (eg, bevacizumab) \<= 30 days prior to randomization
* Clinically significant cardiac disease within 12 months prior to randomization, including myocardial infarction, unstable angina, grade 2 or greater peripheral vascular disease, cerebrovascular accident, transient ischemic attack, congestive heart failure, or arrhythmias not controlled by outpatient medication, percutaneous transluminal coronary angioplasty/stent
* Known allergy or hypersensitivity to irinotecan, 5 FU (known dihydropyrimidine dehydrogenase deficiency) or leucovorin
* Active inflammatory bowel disease or other bowel disease causing chronic diarrhea (defined as \>= CTC grade 2 \[CTCAE version 3.0\])
Nasospore Stent For Use in Enodscopic Sinus Surgery

The purpose of this study is to evaluate a stenting material called Nasopore. This is a synthetic material approved by FDA for use as a stent in postoperative sinus surgery patients. This study will compare the Nasopore stent to other approved stenting materials.

This study will compare other sinus stenting products to the Nasopore stent. The stents will be soaked in antibiotic solutions and be observed for how well they perform. Subjects will have a stent placed in each sinus, stents may be the standard antibiotic saturated materials or the new nasopore material or nasopore stent soaked in antibiotics.

Eligibility Criteria:
Inclusion Criteria:

* Evaluation by Otolaryngologist \& determined to need endoscopic sinus surgery
* Only subjects with Bilateral disease

Exclusion Criteria:

* Pediatric subjects(under the age of 18)
Risk of Rupture of Aneurysms of the Thoracic Ascending Aorta (ATA) From the Dynamic Imaging

Aneurysms of the thoracic ascending aorta are a serious pathology which may threatens life by rupture or dissection. Their incidence is estimated at 10.4 per 100,000 people. At present, the only parameter for assessing the risk of complication is the maximum diameter of the aneurysm. The only way to avoid a complication is a surgical replacement of the aneurysmal aorta by a prosthetic tube. This procedure is performed by sternotomy and with extracorporeal circulation and its death rate ranges between 3% and 5%. Surgical repair is indicated when the diameter of the aneurysm exceeds 5.5 cm for degenerative atheromatous aneurysms or 5 cm in a patient with genetic disorder of connective tissue (Marfan disease or Ehlers-Danlos syndrome). However, there are aneurysms with diameter greater than the surgical threshold which remain stable. Conversely, complications have been described for aneurysms less than 4.5 cm in diameter. The criterion of diameter appears therefore as inadequate to assess the risk of complication of an aneurysm of the ascending aorta.Multiple methods have been described in the literature. One of them relies on in vitro mechanical testing on healthy or aneurysmal tissue. Another method is the vivo analysis from imaging (CT, MRI or ultrasound). So far, no algorithm is robust enough for predicting the risk of complication better than the universally used criterion of diameter.

The pathophysiology of these aneurysms has also been explored from histological studies. The investigators know that the microstructure of the aortic wall of an aneurysm is deteriorated with a degradation of elastin fibers and collagen that determine to a large extent its biomechanical behavior. Histological analysis appears inseparable from biomechanical analysis.


Eligibility Criteria:
Inclusion Criteria:

* Diameter of ATA exceeds 5.5 cm
* Diameter of ATA exceeds 5 cm in a patient with genetic disorder of connective tissue (Marfan disease or Ehlers-Danlos syndrome)
* Diameter of ATA exceeds 5 cm in a patient with aortic valvulopathy
* Written consent

Exclusion Criteria:

* Contra-indication to MRI
* Chronic insufficiency kidney
Ultrasonographic Analysis of Post-Traumatic Shoulder Lesions After Hand Trauma

The purpose of the study is to reveal whether there are concurrent shoulder lesions in patients with hand injuries. Its importance is that it will shed light on whether not only the hand but also the shoulder should be included in the treatment program in hand rehabilitation.

Hand injuries constitute one fifth of the injuries that are brought to the emergency room and one third of the work accidents. They are very costly because they require surgical intervention and a long rehabilitation process and delay the patient's return to work. The general tendency in hand rehabilitation is to focus more on treatments focused on the hand and wrist.

There are studies that draw attention to the relationship between hand grip strength and rotator cuff function and that other upper extremity musculoskeletal injuries are often neglected in patients with hand injuries. This may affect rehabilitation results and prevent the patient from returning to daily activities.

It is reported that in patients with hand and wrist injuries, other upper extremity musculoskeletal problems are seen simultaneously in 40% of cases and most of these are related to the shoulder.

It is reported that rotator cuff problems and lateral epicondylitis are 9 times more common even in carpal tunnel syndrome, which is a relatively simple hand problem that is encountered very frequently in clinical practice.

Traumatic hand injuries can also affect all upper extremity functions. In these patients, it was determined that there was weakness in both the ipsilateral supraspinatus and infraspinatus muscles. The researchers emphasized that the inclusion of shoulder muscle training during the postoperative rehabilitation protocol and selective strengthening of the rotator cuff muscles in distal extremity problems may be clinically important.

In studies conducted to detect shoulder problems in patients with hand injuries, either patient examination or self-reports of the patients have been used so far.

In this study, the investigators aimed to concretely reveal shoulder pathologies by evaluating the results of diagnostic ultrasonography performed on our patients with shoulder symptoms. In this way, the investigators aimed to obtain a clearer result on whether the shoulder should be included in the hand rehabilitation program.

Our study is the first study to evaluate shoulder pathologies in patients with hand injuries with diagnostic ultrasonography.

Eligibility Criteria:
Inclusion Criteria:

* Having a history of hand injury and applying for hand rehabilitation after surgical and conservative treatment.

Exclusion Criteria:

* Being under 18 and over 65 years of age
* Patients with systemic diseases (Diabetes mellitus, Peripheral vascular diseases)
* Any rheumatic disease involving the hand and upper extremity
* History of neuropathy involving the hand and upper extremity
* Those with any shoulder problems prior to the hand injury
* Those with an open wound on the hand
* Those who cannot cooperate
* Other upper extremity traumatic injuries occurring during the hand injury