cyrilzakka/clinical-trials huggingface dataset:
One-Tooth One-Time (1T1T) A Straightforward Approach to Replace Missing Teeth in the Posterior Region: a Case Series

This study evaluates the success rate, as the biological and prosthesis complications, of posterior single-unit implants immediately loaded with a chair side Computer-Aided Design and Manufacturing (CAD-CAM) composite crown, after a follow-up period of 6 months,1,2,3,4 and 5 years.

Complementary ex vivo analyses will be performed to evaluate the wear of restorations. The time and cost benefit of the presented digital workflow, as patient centered outcomes will also be evaluated.


Eligibility Criteria:
Inclusion Criteria:

0 In good systemic health (ASA I/ II)

* Present with no contra indication against oral surgical interventions
* The tooth at the implant site(s) must have been extracted or lost at least 12 weeks before the date of implantation.
* At least 8 mm of bone in the vertical dimension
* At least 6 mm of bone in the bucco-lingual dimension.
* No need for bone augmentation procedure in any of the dimensions
* Full mouth plaque score (FMPI) lower or equal than 25%

Exclusion Criteria

* Autoimmune disease requiring medical treatment
* Medical conditions requiring prolonged use of steroids
* Use of Bisphosphonate intravenously or more then ˃ 3 years of oral use
* Infection (local or systemic) - patient with gingivitis or active local infection will undergo a medical treatment prior to his entrance to the study, each individual will be evaluated prior to study procedure for suitability, in case of systemic infection the evaluation will be based on medical anamneses, and if necessary will be referred to relevant medical tests.
* Current pregnancy or breastfeeding women
* Alcoholism or chronically drug abuse
* Immunocompromised patients
* Uncontrolled Diabetes
* Smokers
* Prisoners
* Conditions or circumstances, in the opinion of the investigator, which would prevent completion of study participation or interfere with analysis of study results, such as history of non-compliance, or unreliability.

Local exclusion criteria:

* Sites treated with socket preservation techniques
* Untreated local inflammation
* Mucosal diseases or oral lesions
* History of local irradiation therapy in Head-Neck area
* Persistent intraoral infection (periodontitis, caries, ...)
* Patients inadequate oral hygiene or unmotivated for normal home care.
* Removable prosthesis as an antagonist of the teeth to be replaced or absence of antagonistic teeth
* Severe bruxism or parafunctions
Efficacy and Safety of MP-424, Peginterferon Alfa-2b and Ribavirin in Non-responder Genotype 2 Hepatitis C Infected Patients

This study will evaluate the efficacy and safety of MP-424 with Peginterferon Alfa-2b and Ribavirin (RBV) in patients with genotype 2 hepatitis C, who did not respond to previous treatment.


Eligibility Criteria:
Inclusion Criteria:

* Genotype 2, chronic hepatitis C
* Non-responders (patient who did not respond to previous treatment)
* Able and willing to follow contraception requirements

Exclusion Criteria:

* Cirrhosis of the liver or hepatic failure
* Hepatitis B surface antigen-positive or HIV antibodies-positive
* History of, or concurrent hepatocellular carcinoma
* History of, or concurrent depression, schizophrenia,; or suicide attempt in the past
* Pregnant, lactating, or suspected pregnant patients, or male patients whose female partner is pregnant
Preliminary Test of Reactive Carrot Incentives in a Practice Quit Environment With Contingency Management Incentives

The primary aim of this study is to pilot test a novel reactive carrot approach for improving individuals' ability to stick to a "practice quit" program in a smoking cessation context. In this study, the treatment gives subjects an offer to forego a monetary incentive to forego the opportunity to receive subsequent abstention (contingency management) rewards.

All the subjects, treatment and control groups, would be given the opportunity to receive attendance rewards for attending six CO testing meetings as well as abstention (contingency management) rewards for abstaining from smoking. The only difference between the subjects randomly assigned to treatment and control groups is that each member of the treatment group would be tempted at the beginning of their program by being offered a one-time monetary incentive to forego the opportunity to receive subsequent abstention (contingency management) rewards. Treatment group subjects would, at their initial intake meeting after the attendance and abstention rewards opportunity had been described, be given a one-time opportunity to received $80 temptation payment to give up the opportunity to receive subsequent abstinence (contingency management) rewards that could be worth as much as $165. Subjects who accepted this one-time opportunity would remain enrolled in the practice quit smoking and they would still be eligible to receive attendance reward compensation totaling up to $30 for showing up to their six testing appointments. The purpose of the study is to test whether resisting the temptation to accept the one-time payment helps steel the resolve of the treatment subjects to follow through and make sure that they earn the subsequent contingency management rewards. More specifically, an intent-to-treat design will allow us to test whether the temptation causes treatment group subjects to have greater success than the un-tempted control group subjects to abstain from smoking during the two-week practice quit period.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* Smoke ≥ 3 cigarettes per week and expressing interest in quitting smoking.

Exclusion Criteria:

* Unstable psychiatric conditions such as suicidal ideation, acute psychosis, severe alcohol dependence, or dementia
* unstable medical conditions that have not been well controlled (e.g., acute infection requiring hospitalization) for the past 30 days
* pregnant or breastfeeding women
* those with limited decision making capacity.
Efficacy and Safety of XAV-19 for the Treatment of Moderate-to-severe COVID-19

The purpose of this study is to evaluate the efficacy and safety of XAV-19 drug in patients with moderate-to-severe COVID-19.


Eligibility Criteria:
Inclusion Criteria:

I1) Male or female patient aged 18 years or over, weighing \>50 Kg and \<120 Kg, at the time of signing the informed consent,

I2) Patient presenting in a specialized or an emergency unit

I3) Patient presenting signs of pneumonia evidenced by at least 1 of the following: auscultation, chest X-Ray, CT scan OR presenting COVID-19 related symptoms having started less than 10 days prior to screening visit, including at least 2 of the following: fever, cough, sore throat or nasal discharge, dyspnea (shortness of breath), thoracic pain, headache or fatigue, myalgia, anosmia, dysgeusia, diarrhea, nausea

I4) Patient with SpO2 \> 90% (at ambient air)

I5) Patient with a first positive SARS-CoV-2 test (RT-PCR, RT-qPCR or antigen test) in the last 10 days or at screening

I6) Women of childbearing potential (WOCBP) must have a negative urine pregnancy test at screening and use a highly effective birth control until 90 days after the administration of study drug

I7) Non-vasectomized male patients having a female partner of childbearing potential must agree to use a highly effective method of contraception until 90 days after the administration of study drug,

I8) Patient capable of giving signed informed consent.

Exclusion Criteria:

E1) Patient with a positive SARS CoV-2 test (RT-PCR, RT-qPCR or antigen test) of more than 10 days before the screening visit

E2) Patient with multiorgan failure

E3) Patient requiring immediate Intensive Care Unit (ICU) hospitalization

E4) Patient participating in another clinical trial with an investigative agent

E5) Pregnancy or breastfeeding
Study of the Golimumab Exposure-Response Relationship Using Serum Trough Levels

The purpose of this study is to gain insight into the exposure-response relationship of golimumab in moderate-to-severe Ulcerative Colitis (UC).

Patients commencing induction therapy with golimumab will be enrolled into a prospective study and evaluated at three time-points (weeks 6, 10 and 14) for clinical and biochemical UC disease activity as well as serum golimumab concentrations and the presence of anti-golimumab antibodies. Patients already established on stable golimumab maintenance therapy will be enrolled into a cross-sectional study with the same evaluations taken at a single time point.

The study will involve two study groups designed to offer insights into the pharmacokinetics of golimumab during induction and maintenance therapy:

Cohort 1: Patients commencing golimumab induction therapy will be included in a prospective, observational study.

Cohort 2: Patients receiving golimumab maintenance therapy will be included in a cross-sectional, observational study.

Primary objective: To define a week 6 serum golimumab concentration that predicts response at week 14.

Secondary objective: To define serum golimumab concentrations at weeks 6, 10 and 14 that predict response at each time point, respectively and at week 14.

Exploratory objectives:

Correlations between serum golimumab concentrations and novel disease activity indices (PRO2), biochemical markers of disease activity (CRP, faecal calprotectin) and quality of life indices (IBD-Q and IBD-Control).

Correlations between the presence of anti-golimumab antibodies, serum golimumab concentrations and UC disease activity.

This study will also generate data that can be used to validate a commercially available golimumab assay as well as a novel patient reported outcome (PRO) assessment of clinical UC disease activity.

Eligibility Criteria:
Inclusion Criteria for cohort 1:

* Aged 18 years or over
* Moderate-to-severe UC, defined as:

SCCAI \> 5 and, i. A raised fecal calprotectin (\> 59 μg/g) or, ii. A raised CRP (\> 5 mg/L) or, iii. Endoscopic disease activity Mayo 2 or above, Evaluated within 4 weeks of study enrollment

* Commencing golimumab treatment
* Written informed consent to participate
* Sufficient English language skills to understand the patient information sheet and consent form

Inclusion Criteria for cohort 2:

* Aged 18 years or over
* Receiving golimumab treatment for UC for over 18 weeks (6 injections)
* Written informed consent to participate
* Sufficient English language skills to understand the patient information sheet and consent form

Exclusion Criteria (cohort 1 only):

* Contra-indication to golimumab: tuberculosis or severe infections
* Imminent need for colectomy (i.e. colectomy is being planned)
* Previous primary non-response to anti-TNF therapy in the opinion of the investigator
* Previous treatment with more than one anti-TNF therapy (excluding golimumab)
Additive Effects of Dental Bite Pads During Gymnastic Exercises for the Relief of Chronic Non-specific Neck Pain in Working Women and Men at a VDU Workplace

The study which includes 52 participants suffering from chronic neck pain, determines additional effects of dental bite pads on neck pain and function when performing a 3-month gymnastics programme.

Chronic neck pain is a common health problem in our society. Targeted gymnastic exercises have a high priority in the context of therapy and have shown positive effects on the symptoms in studies. In the past, direct connections between the temporomandibular joint and complaints of the musculoskeletal system, especially of the shoulder-neck region, have been researched, which are based on neuroanatomical (nerves) and myofascial (muscle-fascia) connections. Against the background of current study results, consideration of these findings could be promising in the therapy of neck pain. A new approach tries to positively influence tension and discomfort in the neck area by changing the position of the temporomandibular joints using dental bite pads. In the planned study, the researchers are specifically investigating the question of the extent to which the placement of dental bite pads (made of silicone) in the molar region during the performance of gymnastic exercises can increase the effect of the exercises on neck pain and the associated restrictions on function and quality of life.

The aim of the present project is specifically to record the effect of a 3-month gymnastics programme and a possible additional effect of dental bite pads. In the study, 52 working women and men with a sedentary job at a computer workstation aged 30-65 years are included and randomly divided into two groups. Both groups will perform a specific video-animated exercise programme for 3 minutes 3 times a day over a period of 3 months with the main focus on the shoulder-neck region. One group positions a silicone dental bite pad (TJ Motion; BELY Balance GmbH \& Co. KG, Weisendorf, Germany) on the right and left side of the molar region during the exercise.

Before the intervention, after 6 weeks and after a further 6 weeks of follow-up, pain and function in the neck area are assessed by questionnaire. At baseline and follow-up, functional tests of spinal and jaw mobility are also performed.

Eligibility Criteria:
Inclusion Criteria:

* Men and women 30-65 LJ
* Chronic non-specific neck pain \[4\] (at least for 3 months, pain intensity ≥2 (NRS) on at least 50% of days).
* Sedentary work, VDU work

Exclusion Criteria:

* Specific neck pain (e.g. herniated disc, spinal stenosis, etc.)
* Cervical spine-related neuronal symptoms (paresthesia, brachialgia, paresis)
* Continuous pain medication
* Concurrent other therapy to influence neck pain
* Absence ≥ 2 weeks during the intervention period
* Regular sports training (≥ 60min/week) in the last 6 months
Signs of Central Sensitization in Tension-type Headache

The goal of this observational study is to assess the pain sensitivity in tension-type headache patients. The main question it aims to answer is:

- Are signs of central sensitization present in tension-type headache?

Participants will be asked to fill out baseline questionnaires and they will be assessed during 1 test moment (static and dynamic quantitative sensory testing).

Researchers will compare tension-type headache patients with healthy controls to see if signs of central sensitization are only present in the tension-type headache group.


Eligibility Criteria:
Inclusion Criteria:

1. Diagnosis of tension headache according to globally recognized criteria (ICHD-3) or verified by a physician
2. Diagnosis of tension headache confirmed by a questionnaire (Headache Screening Questionnaire)
3. Not pregnant or given birth in the past year since a change in hormone levels can affect pain experience
4. Adults between the ages of 18 and 65
5. Proficient in the Dutch language

Exclusion Criteria:

1. Other diagnosis of headache or a mixed form
2. Other existing condition involving central nervous system sensitivity
3. Other structural neurological syndromes
4. Any condition involving the brain in the past
5. Procedure on the head, neck, or shoulder in the past 3 years
6. Currently suffering from a psychiatric condition
7. Athletes competing at a competitive level
8. Not proficient in the Dutch language
9. Currently pregnant.
Silver Graft All Comers Registry

This web based e-Registry will be international, multi-center and prospective. Silver Graft e-Registry to assess the long term clinical benefit of Silver Graft in an unselected patient population

To assess the long term clinical benefit of Silver Graft in an unselected patient population with Peripheral Artery Occlusive Disease (PAOD) fulfilling one of the the following criteria:

1. Any suitable patient in need of an infrarenal vascular reconstruction with Fontaine class IIb or indicated vascular reconstruction aneurysm repair.

   or
2. Any suitable patient with an increased risk for early graft failure except those mentioned under (3). These may include

   * diabetics
   * Fontaine class\> IIb
   * patients of advanced age (≥75 y)
   * patients with renal insufficiency (creatinine ≥ 1.50 mg/dl or ≥130 µmol/l)
   * patients with COPD or documented coronary artery disease (prior PCI, prior CABG, documented myocardial ischemia)
   * patients with major amputation
   * immunosuppressed patients
   * patients with autoimmune disease, malignancy

   or
3. Any suitable patient with graft infection or present infection in the anatomical position of indicated vascular reconstruction.

Eligibility Criteria:
Inclusion Criteria:

1. Any suitable patient in need of an infrarenal vascular reconstruction with Fontaine class IIb or indicated vascular reconstruction aneurysm repair.
2. Any suitable patient with an increased risk for early graft failure except those mentioned under (3). These may include

   * diabetics
   * Fontaine class\> IIb
   * patients of advanced age (≥75 y)
   * patients with renal insufficiency (creatinine ≥ 1.50 mg/dl or ≥130 µmol/l)
   * patients with COPD or documented coronary artery disease (prior PCI, prior CABG, documented myocardial ischemia)
   * patients with major amputation
   * immunosuppressed patients
   * patients with autoimmune disease, malignancy
3. Any suitable patient with graft infection or present infection in the anatomical position of indicated vascular reconstruction.

Exclusion Criteria:

* Any patient with common contraindications for vascular surgery may not be included in this registry.
* Any patient with an estimated life expectancy less than the first follow-up period, i.e. 12 months is excluded from data entry.
* Any patient with a known and documented allergy to silver or silver ions.
END-1: First Line Chemotherapy for Advanced or Recurrent Endometrial Carcinoma With Carboplatin and Liposomal Doxorubicin

The purpose of this study is to evaluate activity and toxicity of the combination of carboplatin and liposomal doxorubicin as first-line chemotherapy of patients with advanced or recurrent endometrial carcinoma.

Treatment is planned with carboplatin AUC 5 given IV on day 1 and liposomal doxorubicin 40 mg/m2 given IV on day 1, with treatment repeated every 28 days. Delays in treatment administration and dose reductions have been planned according to toxicity.

Eligibility Criteria:
Inclusion Criteria:

* Cytologic / histologic diagnosis of endometrial carcinoma
* Indication for chemotherapy
* Age 75 years or less
* Life expectancy of at least 3 months
* Measurable disease \> 1 cm

Exclusion Criteria:

* Previous or concomitant malignant neoplasia (not including basocellular or spinocellular skin carcinoma or in-situ carcinoma of the uterine cervix, provided they are being adequately treated)
* Performance status (ECOG) \> 2
* Previous chemotherapy treatment
* Heart disease (heart failure, myocardial heart attack within 6 months prior to randomization, atrioventricular block of any degree, serious arrhythmia)
* Leukocytes \< 4000/mm3, platelets \< 100000/mm3
* Impaired renal function (creatinine \> o = 1.25 times the upper normal limit) or liver function (SGOT or SGPT \> o = 1.25 times the upper normal limit)
* Present or suspected hemorrhagic syndromes
* Uncooperative and/or unreliable patients
* Patient's inability to access the center
* Refusal of informed consent
Association Between Triglyceride Glucose Index and Severity of Coronary Artery Disease

Coronary artery disease (CAD) is a chronic cardiovascular disease occurring due to atherosclerotic occlusion of the coronary arteries (1).

Acute coronary syndrome (ACS) is the most severe type of Coronary artery disease including unstable angina(UA) , St -elevation myocardial infarction (STEMI) Non ST elevation mayocardial infarction (NSTEMI) (2).

Despite the use of current guidline-recommended therapeutics including Percutaneous coronary intervention (PCI) or coronary Artery bypass Grafting (CABG) and optimal drug treatments some patients with ischemic heart disease (IHD) remain at high risk for recurrent Cardio vascular events(3).

Triglyceride glucose index (TYG) has a good potential in predicting poor cardiovascular prognosis in patients with IHD (4).


Eligibility Criteria:
Inclusion Criteria:

- This study will be conducted on patients investigated for IHD by coronary angiography at coronary catheterization unit at sohag university hospital

Exclusion Criteria:

* 1- Patients younger than 18 years. 2- Patients with malignant tumor disease . 3- Patients with infectious or sever liver or kidney disease . 4- Patients lacked data on HbA1c,FPG,TG.
Stress Echocardiography in the Detection of Pulmonary Arterial Hypertension in Systemic Sclerosis Patients

The purpose of this study is to assess the value in terms of sensitivity, specificity and likelihood ratio of the stress echocardiography in the screening of pulmonary arterial hypertension in patients with systemic sclerosis and indirect signs of pulmonary arterial hypertension.

Pulmonary artery catheterization (rest and exertion) and treadmill stress echocardiography will be done to all patients of the study.

Eligibility Criteria:
Inclusion Criteria:

* At least one of the prespecified indirect sign of pulmonary arterial hypertension
* Able to exercise on treadmill

Exclusion Criteria:

* left ventricular dysfunction at rest
* Absence of pulmonary regurgitant flow
* Pregnancy or breastfeeding
* Smoking with \> 60 pack-year
The Relationship Between Cranial Near-InfraRed Oxygenation(NIRO) and Heart Rate Variability During Mental Exercise

The objective of this study is to investigate the effect of Tai Chi and Qigong practice on cranial oxyhaemoglobin level, blood pressures and autonomic nervous system responses.


Eligibility Criteria:
Inclusion Criteria:

* A minimal of 3 years experience on practice of either Tai Chi or Qigong

Exclusion Criteria:

* Unable to communicate or follow an exercise protocol
* Presence of cognitive impairments
* Symptomatic cardiovascular diseases
* Hypertension
* Diagnosis of stroke
* Parkinson's disease, or other neurologic disorder, peripheral neuropathy and cancer.