cyrilzakka/clinical-trials huggingface dataset:
Clinical and Radiographic of the Effect of Socket Preservation Using the Roll Pedicle Connective Tissue Graft With Bovine Bone: A Case Series Trial.

After tooth extraction, the residual alveolar ridge generally provides limited bone volume because of ongoing, progressive bone resorption. Healing events within post-extraction sockets reduce the dimensions of the socket over time. Therefore, socket preservation became an indispensable procedure as well as fundamental to prevent bone loss following tooth extraction. Preservation, by the name, is the maintenance of the socket, which is essentially the height and width of the gap that is left after the tooth is removed. It is done by placing a graft material or scaffold immediately into the socket of an extracted tooth to presto preserve bone height, width and density

Investigator evaluate the clinical and radio graphic effect of roll pedicle connective tissue graft as a barrier membrane together with bovine bone in alveolar ridge preservation in extraction sockets.

Eligibility Criteria:
Inclusion Criteria:

* • patients with healthy systemic condition.

  * Adult patients ˃ 18 years old.
  * hopeless teeth that need tooth or root extraction in the maxillary esthetic zone.
  * Alveolar socket Grade I and II.
  * Normal platelet counts according to complete blood count (CBC) test done in the screening stage.

Exclusion Criteria:

* Acute infection at the extraction site

  * Smokers ˃ 10 cigarettes / day.
  * Medications that may interfere with wound healing
  * History of treatment with bisphosphonates.
  * History of allergic reaction
Prevalence and Risk Factors of Erectile Dysfunction in Type 2 Diabetic Patients

The investigators evaluated 250 male, type 2 diabetic patients, aged 18-80 years. They will undergo IIEF (International Index of Erectile Function), SAS of Zung (self-rating anxiety state)and SDS of Zung (self-rating depression scale)questionnaires. The investigators will evaluate anthropometric and biochemical parameters, dysautonomic function index, IMT (Intima Media Thickness) index, and fundus oculi examen. Furthermore, the investigators will perform MNSI (Michigan Neuropathy Screening Instrument) and NDS (Neuropathy Disability Score)questionnaires.


Eligibility Criteria:
Inclusion Criteria:

* type 2 diabetes mellitus

Exclusion Criteria:

* type 1 diabetes mellitus
* \< 18 years old
* anatomic abnormalities of the penis
* patients taking erectile dysfunction therapy at the moment of the enrollment
Comparing Efficacy and Safety of Tacrolimus With Steroids or Monoclonal Anti-IL2R Antibody in Hepatitis C Virus (HCV) Positive Liver Transplant Patients

This is an exploratory study to evaluate the impact of eliminating steroid administration upon viral HCV load at 12 months measured by quantitative serum HCV-RNA determination in patients transplanted for HCV cirrhosis.

A comparison will be made between two regimens which both include tacrolimus, one utilizing standard steroid administration and the second with daclizumab (MAB) avoiding steroids for both prophylactic administration and anti-rejection treatment.

Eligibility Criteria:
Inclusion Criteria:

* Patients 18 to 65 years of age who will undergo primary orthotopic liver or split liver allograft transplantation for HCV-cirrhosis are eligible for the study.
* Patients receiving a cadaveric liver transplant with compatible ABO blood type can be included.

Exclusion Criteria:

* Recipient of multi-organ transplant
* Recipient of an auxiliary graft
* Patient is receiving ABO incompatible graft
* Patients requiring immunosuppressive treatment
* Patients requiring ongoing corticosteroid therapy.
* Patient has significant, uncontrolled concomitant infections and/or severe diarrhoea, vomiting, active upper gastro-intestinal tract malabsorption or active peptic ulcer.
* Patient or donor is known to be HIV positive.
* Patient is allergic or intolerant to study medication
* Patient is pregnant or breast-feeding.
* Patient has been previously enrolled in this study
Clinical Significance of Collagen Metabolism Changes in Left Cardiac Ventricle

As there are no clinical data in cardiology about the relationship between metabolism collagen changes and their clinical significance, the investigators will check the hypothesis that collagen metabolism changes, detected by biochemical markers for collagen metabolism, could predict the left ventricle remodelling and prognosis in patient with clinically significant pressure overloaded left ventricle.

Clinical assessment and endpoints:

1ST day (the day of entering the hospital or the day of the first contact): Informed consent (see below), clinical examination, ECG, complete echocardiography evaluating the function of the left ventricle (EF) and the presence and the significance of valvular disease, basic laboratory tests incl. CKMB, troponin I, taking of blood samples (5 ml) for the detection of collagen metabolism markers serum level, X-ray of chest, 2nd-3rd day: clinical examination, ECG, basic laboratory tests incl.CKMB, troponin I (only group I) 4th day: clinical check up, ECG, echocardiography, taking of blood samples (5ml) for the detection of collagen metabolism markers serum level (only group I) 30th day: clinical examination l, ECG, echocardiography, taking of blood samples (5ml) for the detection of collagen metabolism markers serum level, 24 hrs ECG monitoring (holter) 6 months: clinical examination, ECG, echocardiography, taking of blood samples (5ml) for the detection of collagen metabolism markers serum level, holter monitoring

1 year: history, clinical examination

Primary endpoint: combined clinical endpoint: death/repeated hospitalisation due to heart failure/myocardial infarction within 30 days and during 1 year follow up.

Secondary endpoints: rehospitalisation for cardiovascular reason, clinically significant arrhythmias, correlations between left ventricle parameters evaluated by echocardiography and collagen metabolism changes evaluated by serum markers

Eligibility Criteria:
Inclusion Criteria:

1. isolated severe aortic stenosis (index aortic valve area less than 0,5 cm2/m2 or mean transaortic pressure gradient more than 40 mm Hg, assessed by echocardiography) and left ventricular hypertrophy (see above)
2. signed informed consent

Exclusion Criteria:

1. presence of more than mild aortic regurgitation or other significant valvular lesion
2. impossibility to obtain echocardiographic tracing of good quality
3. all other diseases, which significantly influence collagen metabolism (renal failure, insulin dependent diabetes mellitus, bone diseases, hepatic failure)
(Cost-)Effectiveness of SLIMMER Diabetes Prevention Intervention

The overall aim of the project is to evaluate the (cost-)effectiveness of the SLIMMER diabetes prevention intervention in Dutch primary health care.

This is a randomised controlled trial, conducted in a real-life setting (Dutch primary health care).

Eligibility Criteria:
Inclusion Criteria:

* Age 40-70 years
* Impaired fasting glucose (IFG; i.e. venous plasma glucose concentration ≥6.1 and

  ≤6.9 mmol/l) during the past 5 years, according to the GP registration database OR diabetes risk score ≥7 as calculated from the Diabetes Risk Test
* Willing and able to participate in the intervention for at least 1.5 years
* Dutch speaking

Exclusion Criteria:

* Known diabetes mellitus
* Any chronic illness that makes 1.5-years survival improbable, interferes with glucose tolerance, or makes participation in a lifestyle intervention impossible
* Patients with any severe cardiovascular disease (this also includes history of cardiac dysrhythmia), unless GP gives agreement
* Medication known to interfere with glucose tolerance
* Any mental or physical disability that will hinder participation in the lifestyle intervention
* Severe psychiatric disease
* Patients who showed bad compliance in the past
* Participation in another regular vigorous exercise and/or diet programme, i.e.:

  * Intensive exercise programme: any exercise programme offered by a physiotherapist and/or patients sporting at least 3 times a week at their own initiative.
  * Intensive diet programme: patients who visited a dietician at least 3 times during the last year.
Focal Ablation of Cervical Precancer

This is a pilot cohort study of women undergoing focal ablation for high-grade cervical intraepithelial neoplasia (HGCIN). The cohort was recruited from the UCSF Dysplasia Clinics. The standard treatment involves treatment of the entire cervix. Women with HGCIN meeting inclusion criteria were recruited for enrollment into the pilot study of focal treatment. Upon enrollment, they underwent focal ablational treatment rather than standard ablational treatment of the cervix. Follow-up visits were conducted at 2 weeks and 6 months to assess safety, feasibility, and acceptability. The 6-month recurrence rate of HGCIN will be calculated.


Eligibility Criteria:
Inclusion Criteria:

* Age 21-45 yo
* Biopsy-confirmed high grade cervical intraepithelial neoplasia grade 2, 3, or 2/3
* Satisfactory colposcopy, i.e., the entire transformation zone is visible
* Lesion occupying \<= 2 quadrants of the cervix.

Exclusion Criteria:

* Unsatisfactory colposcopy.
* Colposcopic lesion extending into the endocervical canal beyond colposcopic visualization.
* Endocervical curettage positive for high-grade cervical intraepithelial neoplasia.
* Suspicion for invasive cancer on colposcopic exam.
* Glandular dysplasia or atypical glandular cells on cytology.
* Unreliable for follow-up.
* Immunosuppression (HIV, transplant recipient, etc.)
Establishment of Vascular Permeability Model for Research Purpose by Human Umbilical Vascular Endothelial Cells

HUVEC primary cells for researches about the relation between plasma leakage and infections.

This study is going to collect HUVEC primary cells to set up an in vitro model for researches about the relation between plasma leakage and infections.

Eligibility Criteria:
Inclusion Criteria:

* healthy pregnant women
* would like to join this study

Exclusion Criteria:

* venereal disease
MPA AUC Monitoring in Patients Receiving MMF for Diffuse Cutaneous or Pulmonary Involvement in Systemic Sclerosis

To define a target value of AUC MPA to improve the modified Rodnan score and / or respiratory impairment (DLCO or FVC) at one year in patients receiving MMF for the treatment of diffuse cutaneous or interstitial lung damage of systemic sclerosis.

In the treatment of autoimmune diseases, MMF is almost always prescribed at a fixed dose, regardless of AUC, or based on the target of AUC determined for organ transplantation. One study looked at determining an "effective" AUC threshold in systemic lupus erythematosus, which appears to be 35mg / h / l. This was also done for ANCA vasculitis.

We therefore conducted this study to determine a correlation between AUC MPA and the effectiveness of MMF in systemic sclerosis.

Prospective, observational, open study.

Main objective: define a target value of AUC MPA to improve the modified Rodnan score and / or respiratory impairment (DLCO or FVC) at one year in patients receiving MMF for the treatment of diffuse skin involvement or pulmonary function in systemic sclerosis.

The main endpoint will be evaluated on the evolution of the modified Rodnan score at 1 year after the initiation of MMF and / or the evolution of FVC and DLCO at 1 year after the initiation of MMF.

Eligibility Criteria:
Inclusion Criteria:

* Systemic sclerosis meeting the ACR / EULAR criteria of 2013
* Equal or more than 18 years old, able to freely consent to study
* In patients treated for skin damage:

  * Diffuse skin sclerosis (rising above the elbows and / or knees)
  * First clinical sign of systemic sclerosis outside of Raynaud's phenomenon going back less than three years
  * Failure to take other concomitant immunosuppressive treatments or in the last 3 months except corticosteroids.
* In patients treated for lung damage:

  * Interstitial lung damage identified on chest CT, chest x-ray
  * Any duration of progression of systemic scleroderma
  * Prescription of MMF in first line or in relay of a treatment with Cyclophosphamide.
  * Absence of biotherapy in the last 6 months.

Exclusion Criteria:

-
A Study Assessing the Safety and Efficacy of DE-117 in Subjects With POAG or OH Who Are Non-/Low-responders to Latanoprost: FUJI Study

The purposes of this study are to investigate the effect of intraocular pressure lowering efficacy and safety of DE-117 ophthalmic solution in subjects with primary open-angle glaucoma or ocular hypertension who are non-/low-responders to latanoprost ophthalmic solution.


Eligibility Criteria:
Inclusion Criteria:

* Primary open angle glaucoma or ocular hypertension

Exclusion Criteria:

* Patients at risk of progression of visual field loss
* Patients with severe visual field defect
* Patients with any diseases that preclude participation in this study for safety reasons
Intracranial Neurophysiological Signatures of Fear and Anxiety in Humans

Anxiety disorders such as post-traumatic stress disorder (PTSD) and generalized anxiety disorder (GAD) affect a large number of individuals with a significant portion of patients failing to improve with current treatments.

The purpose of this study is to understand the brain mechanisms that produce fear and anxiety in humans. To accomplish this goal, we will measure the brain activity along with the heart rate and skin perspiration of patients while they are completing tasks on a computer. Some of the tasks will also use a virtual reality headset and transport the patient in a video game-like environment. These tasks will expose the participants to various levels of fear-provoking images.


Eligibility Criteria:
Inclusion Criteria:

* 12 years of age or older
* Has undergone acute depth or chronic responsive neurostimulation (RNS) electrode placement
* Willing to provide informed consent and participate in the study Ability to read and write English fluently

Exclusion Criteria:

* Unwilling to provide informed consent
* Has not undergone acute depth or chronic responsive neurostimulation (RNS) electrode placement
* Pregnant women
* Participants with active psychosis
* Participants with suicidal ideation
* Participants with substance abuse issues
Preparation of Patient Autologous Induced Pluripotent Stem Cell-derived Retinal Cells for AMD

This project intends to collect participant somatic cells to prepare autologous induced pluripotent stem cell-derived retinal cells for future cell therapy of age-related macular degeneration patient.

One or more types of somatic cells will be collected from every participant by collecting approximately 100\~500 ml of midstream urine, 20\~30 ml of peripheral blood, skin biopsies (3mm), conjunctiva biopsies (5mm×5mm), etc. Then, these somatic cells will be used to prepare patient autologous induced pluripotent stem cell-derived retinal cells for the cell therapy of age-related macular degeneration patient.

Eligibility Criteria:
Inclusion Criteria:

1. Aged 55-80 years;
2. Clinical diagnosis is consistent with the definition of advanced age-related macular degeneration;
3. The BCVA of the target eye will be lower than 20/200;
4. -8.00 D \< refraction \< +8.00 D, 21 mm \< anteroposterior axis≤ 28 mm;
5. Voluntary as test subjects, informed consent, regular follow-up on time;
6. Voluntary as test subjects to join the associated clinical research on autologous iPSC-derived retinal cell therapy for AMD (ethical approval and informed consent documents will be applied and signed separately);

Exclusion Criteria:

1. Macular atrophy caused by other diseases in addition to AMD;
2. Malignant tumor and history of malignancy;
3. Any immune deficiency;
4. Lens opacities (affecting the central vision), glaucoma, uveitis, retinal detachment, inherited retinal dystrophy, optic neuropathy, and other ocular histories;
5. Other intraocular surgery histories besides cataract surgery;
6. Severe heart failure or the left ventricular ejection fraction \<35% in the previous 6 months;
7. Dialysis or eGFR \<20ml/min/1.73m2;
8. Urine protein/urine creatinine ratio ≥1g/g;
9. Creatinine or albumin/urine creatinine ratio ≥600mg/g;
10. Chronic liver disease with ALT three times over the upper limit of normal value;
11. Combined with severe systemic diseases, such as heart failure, liver disease, COPD, etc.
12. Combined with severe infectious diseases, such as HIV, HBV, HCV, syphilis, etc.
13. HCV-RNA positive, HBV-DNA \>103 IU/ml, or TB, etc., during the infectious period;
14. Use anticoagulant, or the platelet function is still not restored to normal after stopping antiplatelet drugs for 10 days;
15. Abnormal blood coagulation function or other laboratory tests;
16. Use glucocorticoids, immunosuppressive drugs, or antipsychotic drugs in the previous 3 months;
17. Use antipsychotic drugs in the previous 3 months, such as antidepressants drugs, antimanic drugs, etc.
18. Allergy to tacrolimus or other macrolides;
19. A history of addiction to alcoholism or prohibited drugs;
20. Be participating in other intervention clinical trials or receiving other study medications;
21. Informed refusal；
22. Some other situations which might increase the risks of the subjects or interfere with clinical trials, such as mental disorders, cognitive dysfunction, etc.
EAGLE: Evaluating Genotypes Using Intravitreal Aflibercept Injection

Clinical and genetic evaluation of individuals treated with intravitreal aflibercept injection (Eylea) for neovascular age-related macular degeneration (wet AMD)

Clinical and genetic assessment of treatment response in patients with age-related macular degeneration using intravitreal aflibercept injection. This study seeks to determine if different genetic polymorphisms of vascular endothelial growth factor A (VEGF-A) and HtrA serine peptidase 1(HTRA1) and other genes correlate to the response to intravitreal aflibercept injection therapy.

Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 50 years
2. Naïve neovascular wet-AMD (has not received treatment before)
3. Willing and able to comply with clinic visits and study-related procedures
4. Provide signed informed consent

Exclusion Criteria:

1. Previous therapy in study eye for AMD or other retinal disease which may be used in the treatment of AMD
2. Previous subfoveal focal laser photocoagulation involving the foveal center in the study eye
3. History of vitrectomy, submacular surgery, or other surgical intervention for AMD in the study eye
4. Any concurrent intraocular condition in the study eye (e.g. diabetic retinopathy or glaucoma) that, in the opinion of the investigator, could either 4.1 require medical or surgical intervention during the study period to prevent or treat visual loss that might result from that condition, or 4.2 if allowed to progress untreated, could likely contribute to loss of at least 2 Snellen equivalent lines of best corrected visual acuity over the study period
5. Active intraocular inflammation (grade trace or above) in the study eye, or history of idiopathic or autoimmune-associated uveitis in either eye
6. Current vitreous hemorrhage in the study eye
7. History of rhegmatogenous retinal detachment or macular hole (Stage 3 or 4) in the study eye
8. Active infectious conjunctivitis, keratitis, scleritis, or endophthalmitis in either eye
9. Aphakia, ACIOL, or unstable PCIOL
10. Uncontrolled glaucoma in the study eye (defined as intraocular pressure ≥30 mmHg despite treatment with anti-glaucoma medication)
11. Pregnant or breast-feeding women
12. Sexually active men\* or women of childbearing potential\*\* who are unwilling to practice adequate contraception during the study (adequate contraceptive measures include stable use of oral contraceptives or other prescription pharmaceutical contraceptives for 2 or more menstrual cycles prior to screening; intrauterine device \[IUD\]; bilateral tubal ligation; vasectomy; condom plus contraceptive sponge, foam, or jelly, or diaphragm plus contraceptive sponge, foam, or jelly)
13. Any other condition that the investigator believes would pose a significant hazard to the patient if the investigational therapy were initiated \*Contraception is not required for men with documented vasectomy. \*\*Postmenopausal women must be amenorrheic for at least 12 months in order not to be considered of child bearing potential. Pregnancy testing and contraception are not required for women with documented hysterectomy or tubal ligation.
Hypofractionated Radiosurgery for Localised Prostate Cancer (HYPOSTAT-II)

Hypofractionated radiosurgery has been investigated in a few trials and appears to be safe and feasible.

Investigators initiated this multicenter phase II prospective trial to analyse feasibility (toxicity) of hypofractionated radiosurgery with 5 fractions in patients with localised prostate cancer under the hypothesis that the ratio of patients with late toxicity ≥ grade 2 after 3 years amounts 4.1% and is significant lower than 12.3% and 8.7% currently.

Experimental radiosurgery of prostate with 5 fractions each with 7,00 Gy (total application rate of 35,00 Gy).

Planned visits are: Baseline, visits at every radiation day and eight follow ups (4-6 weeks, 3 months, 6 months, 1 year and every year thereafter after last day of radiation).

Eligibility Criteria:
Inclusion Criteria:

* non-metastatic, histopathologically confirmed prostate carcinoma cT 1-3 N0 M0
* Gleason-grade ≤7
* Guideline-based staging
* Age ≥ 60 years
* PSA \< 15 ng / ml
* Volume of the prostate \< 80 cm³
* IPSS-Score ≤ 12
* Written informed consent

Exclusion Criteria:

* Age ≤ 60 years
* History of prior pelvic radiotherapy
* Contraindication to MRI or Fiducial marker implantation (e.g. allergy to gold),
* Immunosuppressive therapy
* Relevant comorbidity thought to adversely affect treatment compliance,
* Legal incapacity or lack of informed consent
Efficacy and Safety of Cobiprostone in Patients With Portal Hypertension

The primary purpose of this study is to determine the efficacy and safety of cobiprostone (at two dose levels) as compared to placebo for lowering portal hypertension.


Eligibility Criteria:
Inclusion Criteria:

* Patient is \>= 18 years of age.
* Patient has clinical and/or pathological diagnosis of intra-hepatic portal hypertension.
* Patient has clinical diagnosis of cirrhosis.
* Patient has undergone variceal banding.

Exclusion Criteria:

* Patient has a Child-Pugh score \>12.
* Patient has portal hypertension resulting from hepatic vein obstruction, portal vein occlusion, schistosomiasis, portal vein thrombosis, splenic vein thrombosis, or Budd-Chiari syndrome.
* Variceal banding procedure was performed within 1 month of the screening visit.
* Patient has active or recurrent variceal bleeding, or has had variceal bleeding within the 12 weeks prior to screening.
* Patient is unwilling to discontinue use of vasoactive drugs from the screening visit through the end of the study.
* Patient has hepatocellular carcinoma that is being medically treated or is advanced.
* Patient has impaired renal function (i.e., serum creatinine concentration \>1.8 mg/dl)
* Patient has a history of liver transplant, or is expected to receive a liver transplant during the study period.
* Patient has undergone a gastrointestinal or abdominal surgical procedure within 90 days prior to the Screening Visit, or has had a bowel resection at any time.
Genetic Basis of Mitral Valve Prolapse

The investigators have successfully identified two novel genetic loci for MVP on chromosomes 11 and 13 and are searching for altered genes in these regions. This requires recruiting large families who may have MVP linked to these or other chromosomes; and obtaining DNA samples from 1,000-1,500 individually affected patients to study the relation between DNA markers throughout the genome and MVP. It is our expectation that the results of this study will lead to the discovery of gene(s) responsible for MVP. This will lead to improved understanding of the disease and, in turn, improved ability to treat and prevent progression in genetically susceptible individuals.

This is a genome-wide association study.

Eligibility Criteria:
Inclusion Criteria:

* Mitral valve prolapse

Exclusion Criteria:

* Other mitral valve diseases