cyrilzakka/clinical-trials huggingface dataset:
A Prospective Study of Different Digoxin Treatment Regimens in Egyptian Hospital

Digoxin is the primary cardiac glycoside in clinical use. Because of the narrow therapeutic index and risk of toxicity, therapeutic drug monitoring is highly recommended. In Egypt, most cardiologists give digoxin holiday for both atrial fibrillation and heart failure, it is not clear if the interrupted digoxin regimens are effective since serum digoxin concentrations might fall below the therapeutic range.

Objective: To evaluate and compare the digoxin serum concentration and patient's quality of life in the continuous versus interrupted digoxin dosing regimens.

Digoxin is a cardiac glycoside prescribed in heart failure and certain supraventricular tachyarrhythmias. It exerts a positive inotropic, neurohormonal, and electro physiologic actions on the heart . For heart failure patients, the targeted steady state serum digoxin level is between 0.5 and 0.8 ng/ml . Ventricular rate control in atrial fibrillation patients will usually require higher digoxin steady state serum concentrations . However, serum digoxin level higher than 2 ng/ml is associated with increased incidence of adverse drug reactions and should be avoided . Because of inter and intra-patient variability, narrow therapeutic index, and risk of toxicity, digoxin doses are calculated based on the patient weight, renal status, indications and drug interactions. Due to substantial overlap between therapeutic and toxic levels of digoxin, therapeutic drug monitoring is a must especially in patients with deteriorating renal function and electrolyte disturbance. In Egypt, most cardiologists give a digoxin holiday for patients with atrial fibrillation and /or heart failure where patients skip the drug doses on Thursday and Friday or Friday only every week to avoid possible drug accumulation and toxicity. It is not clear if these interrupted digoxin regimens really offer safer alternative over the continuous dosing regimens without compromising the effectiveness. It is anticipated that plasma digoxin levels may fall below the therapeutic range during the holiday which may affect patient clinical status and quality of life.

Eligibility Criteria:
Inclusion Criteria:

* Patients with atrial fibrillation (AF)
* with or without congestive heart failure (CHF)
* taking digoxin tablets with or without holiday regimens

Exclusion Criteria:

* taking the following drugs concurrently: amiodarone, verapamil, quinidine and propafenone.
* diagnosed with thyroid disorders (hyperthyroidism \& hypothyroidism).
* diagnosed with renal failure
* pregnant
Comparison of Postoperative Analgesia Methods in Elective Cesarean Section Surgeries

Since many intravenous anesthetic agents administered to the mother can cross the placental barrier and cause fetal side effects, multimodal analgesia strategies with peripheral nerve blocks are preffered with greater safety in elective Cesarean section surgeries.

The primary objective of this study is to compare postoperative opioid consumption and pain scores (NRS) in elective cesarean section patients who receive a transversalis fascia plane block versus those who receive surgical site local anesthetic infiltration in addition to spinal anesthesia.

After Cesarean sections, several factors play a role in the formation of postoperative pain, including parietal stimulation originating from the surgical incision, visceral stimulation originating from the peritoneum, and manipulation of intra-abdominal structures.

To enhance patients' rehabilitation during the postoperative period, promote lactation and infant care, and reduce hospital stays, the most appropriate postoperative analgesia method should be selected.

Since many intravenous anesthetic agents administered to the mother can cross the placental barrier and cause fetal side effects, regional anesthesia techniques are preferred with greater safety in elective Cesarean section surgeries.

In the postoperative period, multimodal analgesia strategies can be used for pain control, and one of these strategies is postoperative peripheral nerve blocks. Ultrasound guided transversalis fascia plane block is one of the preferred methods for postoperative analgesia in cesarean section patients.

The primary objective of this study is to compare postoperative opioid consumption and pain scores (NRS) in elective cesarean section patients who receive a transversalis plane block versus those who receive surgical site local anesthetic infiltration in addition to spinal anesthesia.

Eligibility Criteria:
Inclusion Criteria:

* Patients over 18 years old
* ASA II-III patients undergoing elective cesarean section

Exclusion Criteria:

* ASA IV patients
* Patients with known neurologic or psychiatric disorders
* Patients with clinically significant cardiovascular, respiratory, hepatic, renal or metabolic disease
* Patients with alcohol or drug addiction
* Mentally disabled patients
* Patients with BMI\>30
* Patients who develop massive bleeding or coagulopathy
Attitudes and Smoking Perceptions in the Real Environment

This study will measure appeal and reinforcement for different flavored little cigars/cigarillos (LCCs) in young adults in the laboratory and at-home, via ecological momentary assessment (daily smart-phone surveys)

Participants will attend 4 laboratory sessions that differ by cigarillo smoked: own brand and a then commercially available study cigarillo (Garcia y Vega game cigarillo) in tobacco flavor, concept flavor, and characterizing flavor. Consistent with our work and other's published work8-10, a baseline (BL) period will measure appeal to smoking one's usual brand cigarillo in their home environment for 7 days and then once in the laboratory (\>12-hour abstinence), at the end of the 7 days. Participants will then undergo 3 experimental conditions (counterbalanced, within-subjects): (1) 7 days smoking a concept flavored study cigarillo; (2) 7 days smoking a characterizing flavored study cigarillo; and (3) 7 days smoking a tobacco flavored study cigarillo. Participants will be instructed to switch their usual brand cigarillo for the assigned study cigarillo for each 7-day period. Other tobacco use will be allowed during that time without specific instruction to model real-world behavior. On the last day of each 7-day period of "take home" use, abstinent participants (\>12 hours) will smoke the assigned study cigarillo in the lab ad libitum, where subjective effects (e.g., satisfaction, craving reduction, psychological reward, throat hit), smoke exposure (CO boost), and behavior (e.g., number of puffs) will be assessed During each 7-day period of exposure, participants will complete assessments of cigarillo and other tobacco use and subjective effects to cigarillo use via once daily EMA.

Eligibility Criteria:
Inclusion Criteria:

* Ages18 to 34
* Smoke little cigars/cigarillos (LCCs) "some days" or "everyday"
* Ability to read English at an 8th grade level or higher
* No immediate plans to quit using tobacco

Exclusion Criteria:

* Current use of nicotine replacement therapy (NRT)
* Pregnant, planning to become pregnant, or currently breastfeeding
* Past or current self-reported clinically significant heart disease or hypertension, or other smoking-related disease (by history) that preclude successful study completion Inability to abstain from nicotine/tobacco products for at least 12 hours prior to each of two study sessions
* Report using the study cigarillo brand as their preferred brand (as this will likely unduly influence their perceptions)
* Unwillingness to use "untipped" (e.g., plastic or wood tip) little cigars/cigarillos.
Effects of dapaglifloziN Therapy on Myocardial Perfusion Reserve in Prediabetic Patients With Stable coronarY Artery Disease

The purpose of this study is to investigate the effects of dapagliflozin therapy on myocardial perfusion reserve (MPR) using dynamic SPECT examination in prediabetic patients with stable CAD.

Dapagliflozin therapy versus lifestyle modification improves myocardial perfusion reserve in prediabetic patients with stable CAD.


Eligibility Criteria:
Inclusion Criteria:

1. Men or women at least 18 years of age
2. Prediabetes by ADA criteria (fasting glucose 100-125mg/dl, or HbA1C 5.7-6.4%)
3. Stable coronary artery disease
4. Global myocardial perfusion reserve (MPR) index \< 2.0
5. The patient or guardian agrees to the study protocol and the schedule of clinical and dynamic SPECT follow-up, and provides informed, written consent, as approved by the appropriate Institutional Review Board/Ethical Committee of the respective clinical site.

Exclusion Criteria:

1. Contraindications to dapagliflozin
2. Significant renal disease manifested by eGFR\<30 ml/min/1.73m²
3. Unstable or rapidly progressing renal disease
4. Acute coronary syndrome, or any other major cardiovascular events within the previous 6 months
5. Stent placement, or coronary artery bypass graft surgery within the previous 6 months
6. Planned revascularization within 6 months
7. Significant disease (diameter stenosis \>70% by coronary CT angiography) in major epicardial coronary arteries
8. Heart failure requiring loop diuretics
9. Hepatic disease or biliary tract obstruction, or significant hepatic enzyme elevation (ALT or AST \> 3 times upper limit of normal).
10. Contraindication to adenosine stress test
11. Current treatment for the active cancer
12. Women of child bearing potential who are not willing to use a medically accepted method of contraception. Patient's pregnancy confirmed by positive pregnancy test, or breast-feeding.
13. Expected life expectancy \< 1 year
14. Any clinically significant abnormality identified at the screening visit, physical examination, laboratory tests which, in the judgment of the investigator, would preclude safe completion of the study.
15. Unwillingness or inability to comply with the procedures described in this protocol.
Effects of Continuous Veno-venous Haemofiltration on Plasma Lactate in Critically Ill Patients

Continuous Veno-Venous Hemofiltration (CVVH) can eliminate metabolic products effectively and replace renal function partly. It is widely used in intensive care units (ICUs), especially for patients with acute kidney injury/failure in an unstable hemodynamic status. Lactate is a molecule smaller than glucose, which can pass through filtration membrane freely in CVVH. Therefore, the blood lactate concentrations would no longer reflect tissue oxygenation status in patients with unstable hemodynamic status. However, there is no prospective study evaluated the effect of CVVH on lactate removal in critically ill patients. The influence of different dose of CVVH on lactate elimination is not clear in patients with different level of serum lactate. Our study aimed to find out how the dose of CVVH effects on lactate clearance, and then re-estimate the prognostic value of lactate in critically ill patients with CVVH.


Eligibility Criteria:
Inclusion Criteria:

1. The critical ill patients with acute kidney injury
2. Patients requiring continuous veno-venous hemofiltration
3. APACHE II scores more than 12
4. Arterial lactate is higher than 0.5mmol/L but lower than 15mmol/L (due to the sensitivity and optimal measuring range of the equipment)
5. Continuous veno-venous hemofiltration for at least 12 hrs
6. Hemo-filter age of \<24 hrs

Exclusion Criteria:

1. APACHE II scores lower than 12
2. patients' age are more than 75Y or lower than 18Y
Study To Assess Adverse Events and Change in Disease Activity Of 24-hour Continuous Subcutaneous Infusion Of ABBV-951 In Adult Participants With Advanced Parkinson's Disease

Parkinson's disease (PD) is a neurological condition, which affects the brain. PD gets worse over time, but how quickly it progresses varies a lot from person to person. Some symptoms of PD are tremors, stiffness, and slowness of movement. This study will assess how safe and effective ABBV-951 is in adult participants with PD. Adverse events and change in disease activity is evaluated.

ABBV-951 is an investigational (unapproved) drug containing Levodopa Phosphate/Carbidopa Phosphate (LDP/CDP) given as an infusion under the skin for the treatment of Parkinson's Disease. Adult participants with advanced PD and who have completed M15-736 or M20-339 study will be enrolled. Approximately 130 participants will be enrolled in the study in approximately 60 sites in the United States and Australia.

Participants will receive continuous subcutaneous infusion (CSCI) (under the skin) of ABBV-951 for 96 weeks during the Primary Treatment Period and during the optional Extended Treatment Period.

There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the course of the study at a hospital or clinic. The effect of the treatment will be checked by medical and remote telephone assessments, blood tests, checking for side effects, and completing questionnaires.


Eligibility Criteria:
Inclusion Criteria:

- Completion of the parent study, Study M15-736 or Study M20-339.

Exclusion Criteria:

- Participant considered by the investigator to be an unsuitable candidate to receive ABBV-951 for any reason.
Applied Topical Heat as an Adjunct for Pain Control in First-Trimester Surgical Abortionl

Paracervical blocks are routinely used in first trimester surgical abortions and are a proven method for decreasing procedural pain. Even when paracervical anesthesia is used, an overwhelming majority of women still report at least moderate pain during a first trimester abortion procedure. Other than some non-pharmacologic modalities (music and visualization), only the addition of intravenous medication has been shown to reduce procedural pain. Applied topical heat is effective in alleviating pain in other medical subspecialties, and in gynecology has been shown to reduce pain from dysmenorrhea, but has never been studied for intraoperative pain control during first trimester abortion.

The investigators plan to conduct a double-blinded, randomized, controlled trial investigating the utility of topical heat application as an adjunct to paracervical block in first trimester surgical abortions up to 12 6/7wks. The primary outcome is pain score, measured using VAS, at time of uterine aspiration. As secondary outcomes, the investigators will look at the effect of heat application on pain at time of speculum placement, paracervical block, tenaculum placement, cervical dilation and overall pain. Patient satisfaction will also be assessed. If found to reduce pain during abortion under local anesthesia, the use of heat could offer an inexpensive, safe and universally available adjunct to the paracervical block during this procedure.


Eligibility Criteria:
Inclusion criteria

* Gestational age of 12 6/7 wks or less by ultrasound
* Age 16 years or older
* Requesting pregnancy termination by surgical abortion
* Eligible for outpatient pregnancy termination
* Able to provide informed consent
* English or Spanish\* speaking \*If research assistant hired for project is bilingual
* Electing local anesthesia only

Exclusion Criteria

* Reports active bleeding or severe pain at time of enrollment
* Early pregnancy failure identified on pre-operative ultrasound
* Skin irritation or rash over lower abdomen
* Presumed molar pregnancy
* Possible ectopic pregnancy
* Electing intravenous sedation
* Planned intra-operative sonographic guidance
Microbiome Effects of Extended Use of MI Paste in Elderly Removable Denture Wearers

The purpose of this study is to determine if MI Paste affects the bacteria and fungus present within the mouth, as well as to determine if MI Paste increases denture comfort and retention. MI Paste is a water-based topical dental product that is available without a prescription. It is generally used to treat dental/tooth hypersensitivity (sensitive teeth) in patients and/or to help re-mineralize the tooth enamel in patients. Within this study, there is an off-label use for research subjects to apply above the upper denture.

Potentially-eligible subjects will be invited to the research study that involves consenting and 4 in-person visits (Screening Visit, Visit 1, Visit 2, Visit 3) where the following will be performed at each visit: (i) upper denture/mouth tissues swab sample collected, (ii) survey questions being administered, and (iii) brief oral dental exam (clinical assessment). Furthermore, at Visit 2, subjects will be provided and instructed on how to use MI Paste under their removable upper denture for 14 days and instructed to monitor symptoms of comfort, retention, and dry mouth (if applicable).

Eligibility Criteria:
Inclusion Criteria:

* Greater than or equal to 65 years of age,
* Capacity to independently provide consent,
* Having an adequately fitting removable complete maxillary (upper jaw) denture (no consideration relative to the presence or type of mandibular prosthesis (lower jaw partial or full denture).

Exclusion Criteria:

* ill-fitting complete denture(s),
* presence of pathology indicated for immediate treatment (epulis fissuratum (excess folds of firm tissue form inside the mouth, as a result of rubbing on the edge of dentures that do not fit well), large denture sores),
* currently or previously taking any form of antibiotics or antifungals (oral, intravenous, mouthwashes) over the previous two months that may impact microbial assessments.
* a history of food-based allergies: casein, lactose, or food/cosmetic ingredient preservatives. These exclusions have been made out of an abundance of caution to avoid any potential adverse reaction to MI Paste which contains casein phosphopeptide--amorphous calcium phosphate (CPP-ACP), and several common preservative ingredients in oral care products that may induce sensitivities/allergic reaction in a small portion of the population.
* milk allergy
Relationship Between CMR-derived Parameters of Ischemia / Reperfusion Injury and Timing of CMR in STEMI

This a prospective observational study including patients with ST-segment elevation myocardial infarction undergoing cardiovascular magnetic resonance for clinical reason during the index hospitalization. This local registry stemmed from multi-center european registry on cardiovascular magnetic resonance


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of STEMI
* Undergoing CMR during the index hospitalization

Exclusion Criteria:

* Refractory cardiogenic shock
* claustrophobia
* eGFR\<30 ml/min/1.73m2
GBR With Ptfe With Bovine Bone With and Without Autogenous

Ridge Augmentation in Atrophic Anterior Maxillary Ridges with a Titanium Reinforced Polytetraflouroethelene Membrane and Anorganic Bovine Bone-Derived Mineral in intervention group and Anorganic Bovine Bone-Derived Mineralwith Particulated Autogenous Bone Chips in control group.

CBCT will be done before surgery, immediate after surgery and 6 month to compare the bone gain in mm.

Bone sample will be collected during exposure after 6 month of surgery by trephine bur to assess the bone quality through histo-morphometric analysis in order to determine the size, shape and orientation of the bony trabeculae, the size and porosity of the bony cortex in addition to the new bone/ bone substitute ratio

* 1ry outcome: Amount of bone gain will be measured using linear measurements from CBCT immediate after surgery and after 6 month.
* 2ry outcome: a bone sample will be collected and analyzed under histo-morphometric analysis.


Eligibility Criteria:
Inclusion Criteria:

* • Patients with atrophied anterior maxillary ridge area.

  * Age: 18 years and older.
  * Both sexes.
  * No intraoral soft and hard tissue pathology.
  * No systemic condition that contraindicate bone augmentation

Exclusion Criteria:

* • Heavy smokers more than 20 cigarettes per day.(32)

  * Patients with systemic disease that may affect normal healing.
  * Psychiatric problems.
  * Disorders to bone augmentation are related to history of radiation therapy to the head and neck neoplasia.
  * Pregnant or nursing women.
  * Patients with uncontrolled diabetes mellitus, rheumatoid arthritis or osteoporosis.
  * Patient with previous history of radiotherapy.
Postoperative Morbidity and Mortality After Gastrectomy for Gastric Cancer: Prospective Cohort Study

Gastric cancer is still one of the main health care issue and gastrectomy with lymph node dissection is the only chance to be cure. Even though the development and standardization of gastric cancer surgery, the morbidity of gastric cancer surgery was reported around 20% with less than 1% of mortality in East. In contrast, around 40% of morbidity and 10% of mortality was reported in West. There has been several indexes which can define the complications after surgery, but adapting it into clinical practice is sometimes difficult due to the heterogeneous opinion between surgeons. Thus for clear defining the complications after surgery, consensus between many surgeons and prospective cohort study is necessary. The purpose of this study is collecting the complications data after gastric cancer surgery and defining it with every week meeting by at least 6 or more surgeons' discussion.


Eligibility Criteria:
Inclusion Criteria:

* patients who had histologically confirmed gastric cancer and are going to underwent gastrectomy
* age over 20 years with agree to the study

Exclusion Criteria:

* withdrawal of their agreement
* vulnerable subjects (ex. pregnancy, disabled to decide by him or herself, cannot understand the study such as mental retardation or foreigner)
The Usefulness of Endoscopic Ultrasound-guided Biliary Drainage With a Newly Designed Hybrid Metallic Stent

The purpose of this study is to investigate the feasibility and safety of endoscopic ultrasound-guided biliary drainage with a newly designed hybrid metallic stent.

Endoscopic ultrasound-guided biliary drainage with a fully covered metallic stent was a safe and effective method in patients with malignant biliary obstructions and had a comparatively long patency duration. Nevertheless, the significant rate of distal stent migration cannot be ignored, suggesting the need for a newly designed metallic stent for endoscopic ultrasound-guided biliary drainage.

Eligibility Criteria:
Inclusion Criteria:

* Age \> 20 years
* The presence of an unresectable malignant biliary obstruction
* Failed conventional ERCP stenting

Exclusion Criteria:

* Age \< 20 years
* An inability to sedate the patient due to advanced heart or pulmonary diseases
* A lack of informed consent
Effects of Vital Shower on Quality of Life, Immune Function, Cardiovascular Regulation and Well-being

The aim of this exploratory randomized controlled clinical study is to evaluate the health-promoting effects of Kneipp hydrotherapy, in the form of the Vital Shower in a four-week daily application.


Eligibility Criteria:
Inclusion Criteria:

* Female and male patients between 18 and 70 years of age

Exclusion Criteria:

* Bad general condition
* Serious acute or chronic comorbidity
* Pregnancy and breast feeding period/ in the next 6 months
* Participation in a clinical trial within the last 3 months before enrollment
* Simultaneous participation in another clinical trial
* Raynaud's disease or cold agglutinin disease
* Severe mental illness
* Insufficiently treated dermatological diseases (e.g. neurodermatitis, psoriasis)
* Non-compatible sanitary shower or bath devices