cyrilzakka/clinical-trials huggingface dataset:
Evaluation of Postoperative Pain With Resin Based Sealer vs Zinc Oxide Eugenol Based Sealer After Single Visit Endodontic

The goal of root canal therapy is thorough disinfection and obturation of the root canal system in all its dimensions and promote periradicular tissue repair.This study was done to compare the postopertaive pain after single visit endodontics using resin based sealer and zinc oxide eugeonal sealer

A total of 100 patients requiring endodontic treatment for permanent molar in accordance with the inclusion and exclusion criteria will be selected for the study. The treatment and study design will be explained to the patients in their own comprehendible language and a written informed consent will be obtained from the voluntary patients who participated in the study. A cold test and electric pulp-test was used to assess pulp vitality. Based on clinical and radiographic findings, the patients diagnosis of irreversible pulpitis. Patients will be randomly divided into two groups Group A = resin based sealer and Group B = Zinc oxide eugenol sealer. Prior to treatment the patients will be instructed how to complete a visual analog scale (VAS) to determine their pain score. The VAS included a 10 cm straight horizontal line numbered at each centimeter with the following criteria.Local anesthetic with 2% lignocaine containi Local anesthetic with 2% lignocaine containing 1:80000 epinephrine will be administered to each patient after recording preoperative pain levels . A rubber dam will be applied. The endodontic access cavities will be prepared with endo access burs .Working length will be established with #10 K file and the root canal will be instrumented with one shape rotary system up to #25.6% under copious irrigation with 3% sodium hypochlorite and normal saline. Before obturation root canals will be final rinse with 5 ml of 17% EDTA solution. In both groups, the root canal will be dried with paper points and obturated using gutta-percha cones and Resin based sealer/zinc oxide eugenol sealer. Coronal access cavities will be restored with direct composite restorations using dentinal adhesives and universal composite resin . Postoperative VAS scores will be recorded after 24 h and 48 h to determine their post-operative pain.

Eligibility Criteria:
Inclusion Criteria:

1. Patient who agree to participate in study
2. ASA CLASSIFICATION 1or 2
3. Minimum age of 18years old and maximum age of 65 years old
4. Maxillary and Mandibular single rooted teeth included in the study
5. Patient with symptomatic irreversible pulpitis with either normal apical tissue or symptomatic apical periodontitis.

Exclusion Criteria:

- 1. ASA Classification 3 to 5 2. Patient with immature apices and root resorption will be excluded from the study.

3. Severe periodontal problem. 4. Vertical or horizontal root fractures will be excluded from the study 5. Patients who will be already on analgesia within 24 hours excluded from study 6. Those requiring root canal treatment of two or more teeth ipsilaterally (since the pain caused by any of these teeth can result in false positive reading) will be excluded
A Study of LNP3794 in Subjects With NRAS/KRAS Mutated Advanced or Metastatic Refractory Solid Tumors

This is a Phase I, open-label, dose escalation study of LNP3794 (BI3011441) in subjects with NRAS/KRAS mutated advanced or metastatic refractory solid tumors. The purpose of this study is to evaluate the safety/tolerability, pharmacokinetic and pharmacodynamic profile of the orally administered LNP3794 (BI3011441) as monotherapy at selected dose levels.


Eligibility Criteria:
Inclusion Criteria:

1. Subjects ≥18 years of age
2. Pathologically documented, locally-advanced or metastatic solid malignancy with NRAS or KRAS mutation
3. At least one target lesion that can be measured per RECIST version 1.1
4. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
5. Adequate organ function (bone marrow, hepatic, renal, cardiovascular)
6. Documented disease progression despite appropriate prior standard therapies or subjects for whom no standard therapy exists for their tumor type and disease stage
7. Reproductive criteria (as defined in the protocol)

Exclusion Criteria:

1. Subjects with symptomatic central nervous system (CNS) metastases
2. History of another primary malignancy, with the exception of locally excised nonmelanoma skin cancer and carcinoma in situ of uterine cervix
3. Known active hepatitis B infection or hepatitis C infection
4. Known pre-existing interstitial lung disease
5. Known diagnosis of human immunodeficiency virus (HIV) infection
6. History or current evidence/risk of retinal vein occlusion (RVO) or central serous retinopathy; or known risk factors for RVO or central serous retinopathy
7. Any severe and/or uncontrolled medical conditions or other conditions that, in the opinion of the Investigator, Sponsor, or contract research organization, could affect the subject's participation in the study
8. Impaired cardiac function or clinically significant cardiac diseases
9. Previous treatment with RAS or MEK targeting agents
10. Chemotherapy, biologic therapy, immunotherapy, radiotherapy, or investigational agents within 5 half-lives or within 4 weeks (whichever is longer) prior to administration of the first dose of study treatment
Comparing CAF and TCAF With Soft Tissue Grafting for Treating Multiple Recessions in the Premandibula.

Multiple techniques can be used for recession coverage. The most common techniques are : tunnel technique (T), coronally advanced flap (CAF) or a combination of both (TCAF). Tunnel and coronally advanced flap are frequently used in clinical practice, whereas the combined technique is a rather recent developed surgical approach.

This randomized controlled trial compares CAF and TCAF to determine which technique provides better root coverage for receding gums in the lower front teeth. The main question it aims to answer is:

- What is the average root coverage achieved with each technique in the short and long term?

This may be clinically relevant because covering gum recession can reduce tooth sensitivity, improve aesthetics and make oral hygiene easier.

Researchers will compare the coronally advanced flap (CAF = the gum is detached and repositioned higher) with the tunneled coronally advanced flap (TCAF = the gum is undermined, only partially detached and repositioned higher). In both techniques, a small piece of tissue is removed from the palate, which is used to cover the recession. The purpose of the connective tissue graft under the flap/tunnel is to increase thickness and provide support.

Participants will:

* Undergo surgery (CAF or TCAF, randomly assigned) to cover recessions
* Attend regular check-ups for up to 10 years after surgery
* Keep a postoperative journal (recording medication use, pain levels, tooth sensitivity, etc.)


Eligibility Criteria:
Inclusion Criteria:

* at least 18 years old
* good oral hygiene
* presence of at least 2 recessions in the premandible
* good general health

Exclusion Criteria:

* smoker
* pregnant women (assessed at each visit; if the patient appears pregnant during follow-up, x-rays will not be taken)
Articaine Efficiency in Pulpectomy of Children With Irreversible Pulpitis Under the Age of Four

A two-tailed randomized controlled trial with two parallel arms is aimed to compare success proportions of the articaine and lidocaine groups in children with irreversible pulpitis under 4 years. The participants will be randomly assigned into two equal groups (82 children per group): the control group will receive lidocaine and the intervention group will receive the articaine local anesthesia.

The direct observation tool FLACC was considered to assess pain severity. The behavior was assessed during pulpectomy procedures using the Frankl behavior rating scale (FBRS)


Eligibility Criteria:
Inclusion Criteria:

* Healthy 36-47 month-children (ASA class I or II) weighing at least 15 kilograms
* Children should be intellectually fit, and cooperative, with no behavior or communication abnormalities
* Presence of a carious maxillary or mandibular second primary molars with signs and symptoms of irreversible pulpitis

Exclusion Criteria:

* Molars with unrestorable crowns
* Molars with necrotic pulps, pathological mobility, gingival swelling or abscess, fistulous or sinus tract, or apical periodontitis
Long-term Safety Study of BHV-3500 (Zavegepant*) for the Acute Treatment of Migraine

The purpose of this study is to evaluate the long-term safety of BHV-3500/vazegepant intranasal in the acute treatment of migraine.

\* BHV-3500, formerly "vazegepant", is now referred to as "zavegepant" (za ve' je pant). The World Health Organization (WHO) International Nonproprietary Names (INN) Expert Committee revised the name to "zavegepant" which was accepted by the United States Adopted Names (USAN ) Council for use in the U.S. and is pending formal adoption by the INN for international use.


Eligibility Criteria:
Inclusion Criteria:

* 2-8 moderate to severe migraines/month within the last 3 months
* Migraine attacks present for more than 1 year with age of onset of migraines prior to 50 years of age
* Migraine attacks, on average, lasting about 4-72 hours if untreated
* Less than 15 days with headaches (migraine or non-migraine) per month in each of the 3 months prior to the screening visit
* Ability to distinguish migraine attacks from tension/cluster headaches
* Participants with contraindications for use of triptans may be included provided they meet all other study entry criteria

Exclusion Criteria:

* History of human immunodeficiency virus disease
* History of basilar or hemiplegic migraine
* Current diagnosis of major depressive disorder requiring treatment with atypical antipsychotics, schizophrenia, bipolar disorder, or borderline personality disorder
* History of nasal surgery in the 6 months preceding the screening visit
* History of gallstones or cholecystectomy
* History of gastric, or small intestinal surgery (including gastric bypass, gastric banding, gastric sleeve, gastric balloon, etcetera), or other disease or condition (for example, chronic pancreatitis, ulcerative colitis, etcetera) that causes malabsorption.
* Body mass index ≥ 33
* Hemoglobin A1c ≥6.5%
Study to Evaluate the Use of Resources and the Costs Associated With Carcinoid Syndrome (CS) in Patients With NETs in Spain

The objective of this study is to describe the use of resources and the costs associated with controlled or uncontrolled CS in patients with NETs in Spain.


Eligibility Criteria:
Inclusion Criteria:

* Patient 18 years of age or older.
* Patient with a diagnosis of NET (G1 or G2) treated with Somatostatin Analogues (SSAs) to manage their symptoms.

  1. Group A: patient who has had at least one episode of uncontrolled CS, according to medical criteria, since the start of treatment.
  2. Group B: patient who has not had any episode of uncontrolled CS, according to medical criteria, in the last 12 months.
* Patient able to read and understand the study questionnaires.
* Patient who has given written informed consent to participate in the study.

Exclusion Criteria:

* Patient participating in another clinical study when invited to participate in this study.
* Patient with another severe malignant disease.
* Patient who cannot meet the requirements established in the protocol (non-compliant or unfit to fill in the questionnaires).
* Patient with symptoms or diseases that could be confused with CS or render CS more difficult to evaluate: right cardiomyopathy or diarrhoea of any aetiology other than NET.
Adjuvant Chemotherapy in Combination With Tislelizumab in Lymph Node-Positive Esophageal Squamous Cell Carcinoma

Esophageal cancer is one of the most common malignancies in China, and esophageal squamous cell carcinoma (ESCC) is the predominant histological type. Surgical resection is still a standard therapeutic approach for patients with resectable ESCC, but the prognosis is still disappointing. Although neoadjuvant chemoradiotherapy plus surgery is currently recommended for patients with locally advanced ESCC, it is still an infrequently used procedure in China. The efficacy of adjuvant therapy on ESCC is still controversial. Recently, the CheckMate 577 trial showed that adjuvant nivolumab therapy could improve DFS for patients with residual disease after neoadjuvant chemoradiotherapy plus surgery. However, no optimal postoperative adjuvant therapy was recommended for patients with ESCC received upfront surgery. We designed a prospective randomized controlled tial to study whether immunotherapy could be used with chemotherapy after surgery to improve overall survival in these patients. The primary endpoint of the study is disease free survival, with secondary endpoints of overall survival, safety and toxicity, and quality of life.


Eligibility Criteria:
Inclusion Criteria:

1. Aged between 18 and 70 years
2. Untreated before surgery (e.g. radiotherapy, chemotherapy, target therapy and immunotherapy)
3. Histologically documented squamous cell carcinoma of the thoracic esophagus with positive lymph nodes （T1-3N1-3M0）
4. undergoing radical esophagectomy
5. ECOG (Eastern Cooperative Oncology Group) : 0-1
6. No recurrent disease before adjuvant therapy
7. Normal hemodynamic indices before the recruitment
8. Able to understand this study and have signed informed consent

Exclusion Criteria:

1. previous or concurrent malignancy
2. Interstitial lung disease
3. Requiring systemic treatment with either corticosteroids or other immunosuppressive medications
4. Known or suspected allergy to chemotherapeutic drugs or Tislelizumab
5. Active autoimmune disease
6. Active hepatitis
7. Those whom the investigator considered unsuitable for inclusion
Preoperative Chemoradiotherapy With Cetuximab in Rectal Cancer

This study is to estimate the pathologic complete response rate of cetuximab, irinotecan, and capecitabine concurrent with radiotherapy given preoperatively in patients with resectable rectal cancer.

Daily fractions of radiotherapy at 1.8 Gy to total of 45 Gy to tumor and draining lymph nodes and followed by a coned-down boost of 5.4 Gy to the tumor are delivered concurrently with chemotherapy.

Cetuximab 400 mg/m2 is given intravenously on D-6 (1 week before radiation), followed by 250 mg/m2 once a week (D 1, 8, 15, 22 \& 29).

Administration of irinotecan and capecitabine starts on day 1 of radiotherapy. Capecitabine is administered orally at a dose of 825 mg/m2 twice daily during weekdays (Monday to Friday) during radiotherapy. Irinotecan 40 mg/m2 is given intravenously once a week (D 1, 8, 15, 22 \& 29).

Four to eight weeks after completion of chemoradiotherapy, curative surgery is performed.

Safety evaluation of the study will be performed after the first 6 patients treated. If more than 1 out of 6 patients received less than 70-80% of planned dose of capecitabine or irinotecan, the dosage of chemotherapy in the further study patients will be adjusted by a protocol amendment.

Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed adenocarcinoma of the rectum
* Distal margin of tumor located from 0 to 8 cm from anal verge
* Stage T3/T4 ± N+ by MRI ± endorectal ultrasonography
* ECOG performance status 0-2
* No prior chemotherapy, radiotherapy to pelvis, immunotherapy, and EGFR pathway targeting therapy
* Adequate organ functions
* Patients must sign the informed consent

Exclusion Criteria:

* Malignant disease of the rectum other than adenocarcinoma or arisen from chronic inflammatory bowel disease
* Any defined hereditary colorectal cancer
* Any unresected synchronous colon cancer
* R0 resection of tumor is not clinically possible
* Any distant metastasis
* Intestinal obstruction or impending obstruction, but decompressing colostomy is permitted
* Any previous or concurrent malignancy other than non-melanoma skin cancer or in situ cancer of uterine cervix
* Any other morbidity or situation with contraindication for chemoradiotherapy
* Patients with history of significant gastric or small bowel resection, or malabsorption syndrome, or other lack of integrity of the upper gastrointestinal tract that may compromise the absorption of capecitabine
* History of severe pulmonary disease
* Pregnant or lactating women or patients of childbearing potential not predicting adequate contraception
Study Evaluating The Efficacy Of Varenicline In Cessation Of Oral Smokeless Tobacco Use

The primary goal of this study is to compare efficacy of varenicline to placebo for cessation of use of smokeless tobacco.


Eligibility Criteria:
Inclusion Criteria:

* Male or female daily smokeless tobacco users aged 18 years and older, who are motivated to stop use of all tobacco products.
* Subjects must be daily users of nicotine containing smokeless tobacco and using smokeless tobacco on at least 8 occasions per day averaged over a week.
* Have used smokeless tobacco for at least 1 year prior to screening with no period of abstinence \>3 months in the past year.

Exclusion Criteria:

* Subjects using nicotine containing products (including smoking tobacco) other than smokeless tobacco for 3 months prior to screening.
* Subjects with exhaled Carbon Monoxide (CO) \>10 ppm at baseline.
* Subjects who have used varenicline, bupropion, or NRT within 3 months of screening.
* Subjects currently or within the past 12 months requiring treatment for depression or have a current or prior history of panic disorder, psychosis, bipolar disorder or any other serious mental illness.
Colesevelam Versus Placebo in Cholestatic Pruritus

38 patients with pruritus due to chronic cholestatic liver disease will be evaluated in an investigator initiated, multicenter, double-blind, placebo-controlled, 3-week study assessing the effects of colesevelam on pruritus. Colesevelam is an oral, non-absorbable bile-acid sequestrant much more potent than cholestyramine but free of adverse effects. It is registered as a lipid lowering agent. The intensity of symptoms will be scored by means of daily Visual Analogue Scales (VAS). Fatigue, quality of life and cutaneous scratch lesions will also be evaluated using quantitative instruments.


Eligibility Criteria:
Inclusion Criteria:

* patients with pruritus as a result of a cholestatic disorder
* age above 18 years
* informed consent

Exclusion Criteria:

* use of cholestyramine
* pregnancy
* inability to understand or speak Dutch language
* malignancy/life expectancy \<6 months
An Advanced Echocardiographic Evaluation of Nebivolol

The purpose of this study is to determine if Nebivolol has any effect on heart function determined by changes in echocardiographic data or exercise tolerance.

Subjects will be given either 5 or 10 mg daily of oral Nebivolol for blood pressure control. They will undergo stress echocardiography at baseline, day 14, 90 and 180.

Eligibility Criteria:
Inclusion Criteria:

1. Diagnosis of hypertension
2. Written informed consent before initiation of any study related procedure
3. Baseline Blood pressure \> 140 systolic or \>90 diastolic if on no antihypertensive therapy.
4. Currently taking one antihypertensive or one antihypertensive and one diuretic for the treatment of hypertension.

Exclusion Criteria:

1. Physical limitations resulting in a limited ability to walk on treadmill for stress echo
2. Intolerance to beta blockers
3. On more than one medication for the treatment of hypertension unless the second medication is a diuretic.
4. Currently pregnant or breast feeding.
5. LFT \> 3 X ULN
6. HgA1C \> 7
7. Participation in other clinical research studies involving the evaluation of other investigational drugs or devices within past 30 days of enrollment
8. Unwilling to follow protocol or return for study related procedures.
9. Any of the following conditions:

   Coronary artery disease Heart failure Valvular heart disease Ischemic heart disease Atrial fibrillation Pacemaker ICD Hyperlipidemia Diabetes Mellitus Stroke/TIA Anemia COPD Asthma Renal failure requiring dialysis Liver failure Cirrhosis Thyroid dysfunction
10. Any other medical condition that in the PI's opinion could affect myocardial function.
11. Current ETOH or illicit drug abuse -
Specific Methylation Profiles in HNSCC

In the study, N-20190047, the investigators aim to define specific methylation patterns in a group of patients with head and neck squamous cell carcinomas.

With this study the investigators aim to validate these findings in a larger cohort.


Eligibility Criteria:
Cancer group:

Inclusion Criteria:

* Written informed consent
* Verified head and neck squamous cell carcinoma

Exclusion Criteria:

* Other active cancer
* Uncontrolled comorbidity
* Unable to give informed consent

Control group:

Inclusion Criteria:

* Written informed consent
* Normal ENT-examination

Exclusion Criteria:

* Other active cancer
* Uncontrolled comorbidity
* Unable to give informed consent
Plant Stanol Esters and Preventing Asthma Symptoms

Plant stanols are known to lower low-density lipoprotein cholesterol. However, studies have suggested that these compounds also influence the immune system. Asthmatic responses are predominantly T helper (Th)2 cell dependent, while plant stanols were previously found to activate Th1 cells and shift the immune response away from the Th2 cell dominant asthmatic response. The question now is whether this also translates into a reduction of clinical symptoms in asthma patients.The primary objective of this study is to demonstrate clinical benefits of prolonged consumption of plant stanols (delivered via plant stanol esters) in asthma patients. The secondary objectives are to evaluate the mechanisms via which plant stanols modulate the immune system and to evaluate the effects of plant stanol ester consumption on cardiovascular (CVD) risk parameters.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with allergic asthma (GINA step 1-4) which is in a stable phase at the moment of inclusion (defined as no changes in asthma control and lung function in (at least) the past three months)
* Have been treated with prescribed asthma medication for at least one year
* Aged 18-70 years old
* BMI between 20 and 35 kg/m2
* Willing to abstain from products containing plant sterols or stanols one month prior to the study (products with a cholesterol lowering claim of Becel ProActiv, Benecol, Danacol, store brands)
* Willing to abstain from products containing plant sterols or stanols during the study (products with a cholesterol lowering claim of Becel ProActiv, Benecol, Danacol, store brands)
* Willing to keep the intake of fish oil supplements constant

Exclusion Criteria:

* Currently smoking or quitted smoking in the past year, with a maximum of 10 packyears as smoking history (packyears = packs per day \* years of smoking)
* Allergy to an ingredient of the soft chews
* Suffering from inflammatory diseases (for CVD, illness must be minimally 3 years ago and currently under control in order to participate in the study)
* Fasting plasma glucose \> 7.0 mmol/L
* Fasting serum TC \> 8.0 mmol/L
* Having donated blood within one month prior to the start of the study, or planning to donate blood during the study
* Pregnant women
* Breastfeeding women