cyrilzakka/clinical-trials huggingface dataset:
Periodontal Phenotype and Laterally Positioned Flap in Isolated Gingival Recession

The aim of this study is to estimate the effect of periodontal phenotype on the outcome of isolated gingival recession by laterally positioned flap.The primary objective of study is to assess the changes in gingival margin in the donor tooth after laterally positioned flap over a period of 6 months and to assess the influence of periodontal phenotype on the stability of results of root coverage achieved through laterally positioned flap. The secondary objective of this study is to evaluate root coverage by laterally positioned flap in thick periodontal phenotype and to evaluate root coverage by laterally positioned flap in thin periodontal phenotype.

A variety of surgical techniques have been proposed to achieve successful and predictable root coverage. These include coronally advanced flap, lateral positioned flap (LPF) free gingival graft, free connective tissue graft, and guided tissue regeneration. LPF, originally described by Grupe and Warren in 1964 is one of the most commonly performed root coverage technique.The procedure has undergone various modification over the years .Staffileno and pfeifer and Heller advocated the use of split-thickness flap to minimize the potential risk for the development of recession in the donor tooth.Wood et al used re-entry procedures to compare crestal radicular bone responses to full and partial thickness flaps. They concluded that regardless of the flap procedure, loss of crestal bone depended on the periodontal phenotype.The term periodontal phenotype refers to phenotypic characteristic of bone and soft tissue that make up the periodontium. Periodontal phenotype is typically used to describe the buccolingual tissue thickness and gingival morphology. It is divided into thick flat and thin scalloped type. However there is a paucity of studies in the literature studying the effect periodontal phenotype on the root coverage obtained and its stability over time after LPF. Furthermore the impact of periodontal phenotype on the donor area in this procedure has not been explored. Therefore the present study is designed with the aim to evaluate the influence of periodontal phenotype on the outcome of root coverage by LPF.

Eligibility Criteria:
INCLUSION CRITERIA

* Isolated Miller's class I, class II, and class III gingival recession in the anterior region
* Gingival Recession depth should be ≥2mm.
* Width of keratinized gingiva ≥3 mm on the immediately adjacent tooth

EXCLUSION CRITERIA

* Patients with a history of systemic condition that might alter the course of disease and /or wound healing such as diabetes mellitus, immunologic disorders.
* Pregnant and lactating women .
* Non vital tooth
* Smokers
* Caries, cervical abrasion or restoration on the labial aspect of tooth with gingival recession.
* Periodontal surgical treatment during previous 24 months on the involved sites.
* Miller's class IV. All potential participants would be explained the need and design of study .Only those subjects who consented for the study will be included after obtaining an informed consent.
Single Arm Trial of Preoperative Stereotactic Body Radiation Therapy (SBRT) for T3a or Gleason Grade Group 4 Prostate Cancer

This study involves Stereotactic Body Radiation Therapy (SBRT) followed by prostatectomy (removal of the prostate). SBRT is a relatively new radiation technique in which a few doses of radiation are delivered to small, well-defined tumors. It has been used effectively in other cancers like lung and liver. The radiation will be given for only 5 days.

The purpose of this study is to compare the effects, good and/or bad, of different doses of SBRT given before prostatectomy.


Eligibility Criteria:
* Histologically proven prostate adenocarcinoma.
* Clinical stage ≤T3a based on digital rectal exam (DRE) and ≤T3a based on MRI (within 3 months); N0-Nx; M0-Mx, or Gleason score 4 + 4. No more than 1 lymph node \>1 cm.
* PSA ≤ 50 ng/ml, obtained within 3 months
* Prostate volume: ≤60 cc.
* IPSS score ≤15.
* No previous radiotherapy to the prostate or lower pelvis.
* Lymph node risk of \<35% using https://www.mskcc.org/nomograms/prostate/pre_op.
* No prior radical prostatectomy or cryotherapy of the prostate (prior transurethral resection or laser ablation are permitted).
* No implanted hardware or other material that would prohibit appropriate treatment planning or treatment delivery, in the investigator's opinion.
* No history of an invasive malignancy (other than this prostate cancer, or non-metastatic basal or squamous skin cancers) in the last 3 years.
* No androgen deprivation therapy (ADT) can be prescribed prior to or during radiation therapy.
* Participant must be able to have gold fiducial markers placed in the prostate. Note: patients can be enrolled after fiducial markers have been placed, as long as the procedure was done in accordance with the protocol (Section 4.2.2).
* Eastern Cooperative Oncology Group (ECOG) performance status ≤2
* Ability to understand and the willingness to sign a written informed consent document.
* Willing to fill out quality of life questionnaires.
Systemic Lupus and Adverse Pregnancy Outcome

prospective analytical study of all pregnant ladies with systemic lupus in Beni-suef localities


Eligibility Criteria:
Inclusion Criteria:

* all pregnant ladies with settled diagnosis of systemic lupus

  * all pregnant ladies who first diagnosed as systemic lupus during current pregnancy

Exclusion Criteria:

-
The Effects of Attention Training on Emotion Regulation and Stress Related Complaints During COVID-19

Attention control for external information and cognitive control for internal information play a causal role in emotion regulation according to different theories and empirical research. Former research in the lab of the investigators has shown positive effects of an interactive attention control/interpretation training, in which participants learned to unscramble scrambled sentences ("life is my a party mess") in a positive way ("my life is a party") by getting eye-tracking feedback about attention for positive ("party") vs. negative information ("mess"). After the training, participants could better reinterpret negative photos in a positive way. Attention- and cognitive control mechanisms prior to negative stressors (proactive control) and after negative stressors (reactive control) seem to play a role in this. Moreover, research has shown that low perceived control and negative expectations about future emotion regulation skills results in lower proactive control and a higher need of reactive control. Based on this, the assumption can be made that the effects of attention control training - targeting reactive control - could benefit from adding techniques that affect proactive control (e.g. psycho-education). In the present study this is investigated by testing a new two weeks attention control training to see if this has a positive effect on stress related complaints, depressive symptoms and emotion regulation. Given that the current COVID-19 pandemic is perceived as very stressful by a lot of people, the training could help here. Participants between 18 to 65 years of age are recruited during this corona crisis. The attention control training is a new smartphone based application. Participants have to unscramble scrambled sentences into grammatically correct sentences. In the training condition, participants are asked to unscramble the scrambled sentences in a positive way. By swiping, participants can see part of the sentences. This gives the investigators an image about the processing of the sentences. This procedure allows to measure how long participants attend to positive and negative words. In the training condition participants get feedback about the duration they process positive and negative words. In the control group participants unscramble the sentences as fast as possible without feedback on emotional attention. Participants only get feedback about the speed at which sentences are unscrambled. Before and after the 10 training sessions, attention of the participants is measured to see the effects of the training. Questionnaires on depressive and anxiety complaints, emotion regulation strategies, well-being and stress are administered before and after the training. There is also a follow-up measure 2 months after the training. Both groups (training and control) watch a psycho-education video before the start of the training.


Eligibility Criteria:
Inclusion Criteria:

* Android smartphone

Exclusion Criteria:

* severe depressive complaints
Prevalence of Anal High-risk Human Papilloma Virus Infection and Abnormal Anal Cytology in Men Who Have Sex With Men Using Pre Exposure Prophylaxis

The aim of the study is to determine the prevalence of anal high-risk HPV infection and abnormal cytology in HIV uninfected Men who have sex with men (MSM) using PrEP and HIV infected MSM followed-up at the S-kliniek or HRC of the UZ Brussel. 200 participants will be preferably included in the study. The data will be collected using a self-administered questionnaire where socio-demographic characteristics, health-related issues and sexual behavior will be questioned. Also anal canal sampling will be performed for cytological analysis. For the HIV infected MSM, additional information will be extracted from the patient files: CD4+ T-cell count and nadir and duration of combination antiretroviral therapy.


Eligibility Criteria:
Inclusion Criteria:

* HIV uninfected MSM of 18 years or older using PrEP since at least 3 months
* HIV-infected MSM of 18 years or older

Exclusion Criteria for MSM using PrEP:

* Any intervention in the (peri-) anal region in the past 3 months
* enema within 24h before sampling
* receptive anal sex within 24h before sampling
* current/ongoing peri-anal topical HPV-treatment

Exclusion Criteria for MSM infected with HPV:

* none
Lower Fluorescein Sodium Dose on Confocal Laser Endoscopy Image Quality and Yellow Discoloration of the Skin

This study was to test an appropriate dose of fluorescein sodium which can provide high image quality to ensure endoscopy examination and have no yellow dye in the skin by a randomized blinded controlled trial.

Fluorescein sodium is one of the commonly used staining agents in confocal laser endoscopy, a device for in vivo real-time histological observation of the gastrointestinal mucosa. The conventional intravenous dosage of fluorescein sodium is in the range of 5ml to 10ml of 10% fluorescein. Image quality can be guaranteed with this range of fluorescein sodium, but yellow discoloration of the skin seriously influences daily life. This study was to test whether a lower dose of fluorescein sodium, which has minimal discoloration of skin, can provide satisfied image quality by a randomized blinded controlled trial.

Eligibility Criteria:
Inclusion Criteria:

* Only those with normal mucosa and minor gastritis from 18 were included.
* patients with aged 18 years to 80 years
* patients with normal mucosa and minor gastritis
* willing to provide informed consent

Exclusion Criteria:

* serious coagulopathy dysfunction, severe cardiopulmonary disease, bronchial asthma, liver and kidney dysfunction, allergy to fluorescein, pregnancy women or breast feeding.
* patients with peptic ulcer, gastric cancer, remnant stomach, acute serious gastritis were also excluded.
* unwilling to provide informed consent
The Impact of a Moderate Carbohydrate Diet in Children With Type 1 Diabetes on Hybrid Closed-loop Therapy

In the past, carbohydrate restriction was indicated as a treatment for people with type 1 diabetes when exogenous insulin was not available. Now it is mainly used as an added treatment for people with type 1 diabetes on top of standard insulin administration and glucose monitoring. Despite previous studies, the impact of carbohydrate restriction on glycemic control and quality of life is still not clear. Furthermore, few studies exist on carbohydrate restriction in children with type 1 diabetes and combined with the use of hybrid closed-loop insulin delivery. Therefore this study will determine the impact on glycemic control and the feasability of a moderate carbohydrate diet compared to a traditional diet in children (7-17 years) with type 1 diabetes on top of using a hybrid closed-loop system. In this randomized, crossover study, 28 children will follow a moderate carbohydrate diet (four weeks) and a traditional diet (four weeks) in randomized order. With a run-in period (two weeks) prior to the first diet and a wash-out period (six weeks) between the two diets, the children will participate in the study for a total of 16 weeks. The primary endpoint is the difference of time spent in target range (defined as a sensor glucose value between 70 and 180 mg/dL) between the four-week moderate carbohydrate diet and the four-week traditional diet.


Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent (ICF) (both children/adolescents and parents)
* ≥7 and ≤17 years old at moment of ICF signature
* ≥6 months type 1 diabetes diagnosis at moment of ICF signature
* ≥3 months use of the hybrid closed-loop system Medtronic MiniMedTM 780G, Tandem t:slim X2 Control-IQTM or Mylife Ypsopump with CamAPS algorithm at moment of ICF signature
* Ability to understand, read, write and speak Dutch, French or English at moment of ICF signature

Exclusion Criteria:

* \<7 or \>17 years old at moment of ICF signature
* \<6 months type 1 diabetes diagnosis at moment of ICF signature
* \<3 months use of the advanced hybrid closed-loop system Medtronic MiniMedTM 780G, Tandem t:slim X2 Control-IQTM or Mylife Ypsopump with CamAPS algorithm at moment of ICF signature
* Any other insulin therapy than advanced hybrid closed-loop system Medtronic MiniMedTM 780G , Tandem t:slim X2 Control-IQTM or Mylife Ypsopump with CamAPS algorithm at moment of ICF signature
* Failure to understand, read, write or speak Dutch, French or English at moment of ICF signature
A Study of Surgical Techniques During Cystectomy

The purpose of this study is to look at two standard surgical techniques used during a radical cystectomy and see whether they influence outcomes such as length of stay in the hospital and infections after surgery. This trial will evaluate whether the following surgical methods influence outcomes:

A ureteral stent is a thin tube that is placed in the ureter to drain urine from the kidney. Ureteral stents are often used to promote urine drainage after radical cystectomy, but may come at risk of urinary tract infection.

Alvimopan is a standard drug used to promote return of bowel function following surgery. Doctors do not know whether alvimopan is beneficial in current clinical practice.

The surgeon will decide whether participants will receive a stent and/or alvimopan, but if they are unsure what the best approach is, a surgical technique has been assigned by chance to them.


Eligibility Criteria:
Inclusion Criteria:

Stent vs. no stent

* Patients aged ≥21 years who are scheduled to undergo radical cystectomy for treatment of bladder cancer with one of the consenting surgeons at MSK Alvimopan vs. no alvimopan
* Patients aged ≥21 years who are scheduled to undergo radical cystectomy for treatment of bladder cancer with one of the consenting surgeons at MSK

Exclusion Criteria:

Stent vs. no stent

* No exclusion criteria Alvimopan vs. no alvimopan
* Patients on chronic opioid therapy are ineligible to receive alvimopan and will be excluded from this cohort of the trial
Pharmacokinetics of Ertapenem in Continuous Venovenous Hemodialysis

Critically ill patients in the intensive care unit often receive continuous hemodialysis to treat their kidney failure. Ertapenem is an antibiotic often used in these patients. Continuous dialysis may remove ertapenem, putting patients at risk for inappropriate treatment of their infection. This study will determine how much ertapenem is removed by continuous hemodialysis.

Subjects receiving CVVHD will receive a one gram dose of ertapenem. Serial blood samples over 24 hours will be taken to assess the ertapenem blood concentrations over time. Spent dialysate and urine samples (if any) will also be measured for ertapenem content to determine how much drug is removed by CVVHD and kidneys. A pharmacokinetic evaluation will be made to determine what is the most appropriate dose for this drug in patients receiving CVVHD to achieve pharmacokinetic and pharmacodynamic goals.

Eligibility Criteria:
Inclusion Criteria:

* Hospitalized in ICU
* Receiving Continuous hemodialysis
* Prescribed ertapenem
* Informed consent granted

Exclusion Criteria:

* \< 18 years of age
* Allergy to ertapenem or other carbapenem antibiotic
* Severe, life-threatening reaction to penicillin or cephalosporins
* Patients experiencing or with history of CNS disorders (eg: seizure, stroke)
* Patients experiencing CNS infection
* Inability to complete 24 hours of CVVHD
* Concurrent use of other extracorporeal therapies such as extracorporeal membrane oxygenation, plasmapheresis or intermittent hemodialysis
* Inability to obtain informed consent
* Pregnant and/or breastfeeding women
Research of Laser Ablation for the Treatment of Lower Anogenital Tracts' Precancerous Lesions

Using multiple targeting CO2 laser ablation to treat the precancerous lesion of the female lower anogenital tracts and analyzing the data collected in the study, we aim to form the standard strategy of laser ablation method to increase the effective rate and lower the rate of relapse and progression.

Patients diagnosed with CIN, VaIN, VIN, AIN or PAIN are recruited with exclusion of suspicion of malignant tumors. We use multiple targeting CO2 laser ablation to treat the precancerous lesion of the female lower anogenital tracts and then follow up the patients for at least two years. By analyzing the data collected in the study, we aim to form the standard strategy of laser ablation method to increase the effective rate and lower the rate of relapse and progression.

Eligibility Criteria:
Inclusion Criteria:

1. Had the history of sexual life.
2. Transferred to colposcopy examination and biopsy for abnormal screening of cervical cancer, contact bleeding of cervix, recurrent discomfort of vulva or abnormal signs of lower genital and anal tract. The pathology of biopsy indicate CIN, VaIN, VIN, AIN, or PaIN.
3. If CIN, the colposcopy manifests transformation zone-1 which means the lesion can totally be seen. However the consideration of fertility damage of resection overweighs the chance of suffering cancer.
4. The patients can accept multiple laser ablations and colposcopy examinations and follow-up at least 2 years.

Exclusion Criteria:

1. Patients who are suffering cancers of other systems and in treatment.
2. Patients suffering acute inflammation of lower genital and anal tracts.
3. The colposcopy and pathology examination suspect of cancer of lower genital and anal tract.
4. Patients suffering severe diseases such as insufficiency of liver and kidney function, diseases of blood system and other acute infections who will get heath harm from colposcopy and laser vaporization.
What Factors Area Associated With Prognosis After Steroid Hydrodilatation for Adhesive Capsulitis

To investigate the factors associated with improvement after intraarticular steroid injection for patients with Frozen shoulder

Objective: To investigate the factors associated with improvement after intraarticular steroid injection for patients with Frozen shoulder

Design: Prospective study.

Participants: Patients with Frozen shoulder were recorded the demographic data, associated disease, ultrasound findings at baselines.

Intervention: One shot intraarticular steroid hydrodilatation

Main Outcome Measures: Visual analog scale (VAS) of the shoulder pain, Constant score, SPADI score, and angles of active and passive shoulder range of motion (flexion, abduction, external rotation, and internal rotation) at pre-treatment, post-treatment at week 8

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of frozen shoulder by physical examination and ultrasonography

Exclusion Criteria:

1. other conditions involving the shoulder ( rheumatoid arthritis, Hill-Sachs lesions,osteoporosis, or malignancies in the shoulder region);
2. neurologic deficits affecting shoulder function in normal daily activities;
3. shoulder pain caused by cervical radiculopathy
4. a history of drug allergy to xylocaine
5. pregnancy or lactation;
6. received injection into the affected shoulder during the preceding 3 months
A Clinical Study to Evaluate the Safety and Efficacy of the Combination of Aliskiren and Amlodipine in Hypertensive Non Responders Patients

To evaluate the blood pressure lowering effect and safety of aliskiren 150 mg used in combination with amlodipine 5 mg in patients with essential hypertension not adequately responsive to amlodipine 5 mg.


Eligibility Criteria:
Inclusion Criteria

* Patients with essential hypertension
* Patients who are eligible and able to participate in the study Exclusion Criteria
* Severe hypertension
* History or evidence of a secondary form of hypertension
* History of Hypertensive encephalopathy or cerebrovascular accident. Other protocol-defined exclusion criteria may apply.
NDPH Biomarker Study in Children and Adolescents

This study will recruit pediatric patients with NDPH (New Daily Persistent Headache), characterize their headache in a standard manner, and treat the NDPH with standard medications used for treatment of headaches in this population. Response to treatment with CGRP blocking Ab medications will be evaluated. Biomarkers related to headache disorders will be measured before and after treatment.

Subjects age 10-18 with diagnosis of NDPH (International Classification of Headache Disorders D ICHD-3 criteria) will be recruited for the study. Consenting subjects will receive standard headache care and treatment, including treatment with CGRP Blocking Ab medications. Blood will be drawn before and after treatment, with assessment of Calcitonin Gene Related Peptid, Pituitary Adenylate Cyclase Activating Peptid (PACAP), Brain derived Neurotrophic factor (BDNF), Nerve Growth Factor (NGF), and Tumor Necrosis Factor alpha, and Vasointestinal peptic (VIP) before and after treatment.

Eligibility Criteria:
Inclusion Criteria:

* Patients between 10-18 yo with diagnosis of new daily persistent headache (ICHD-3 criteria) who have normal developmental history for age
* Subject and parent legal guardian able to communicate in English, understand and consent to study
* Subject will to undergo monthly injections at home for treatment of NDPH
* Normal neuro imaging
* No prior treatment with CGRP blocking medications or botulinum toxin

Exclusion Criteria:

* History of Reynauds syndrome
* History of concussion or prior neurosurgery
* Any structural brain lesion including hydrocephalus, congenital anomalies (including chiari malformation)
* History of psychiatric disorders
* History of any headache disorder (including migraine) prior to the diagnosis of NDPH
* Pregnancy
* Prior treatment with any CGRP blocking medication
* Treatment with Botulinum toxin injections previously
* Any other condition that in the opinion of the PI would interfere with the planned study treatment