cyrilzakka/clinical-trials huggingface dataset:
An-Art Study: Atrioventricular (AV) Node Ablation in Cardiac Resynchronisation Therapy

Cardiac resynchronisation therapy (CRT) is a highly effective treatment option for patients with symptomatic heart failure and electrical intraventricular dyssynchrony, who are unresponsive to medical therapy. CRT has been shown to improve the quality of life in these patients and lately two studies had shown a mortality reduction with and without the adjunct of an implantable cardioverter defibrillator (ICD). Unfortunately, up to 25% of the CRT recipients do not show a symptomatic improvement after device implantation ("non-responder"). Because of possible intermittent tachycardiac intrinsic conduction, it remains difficult in numerous patients to assure a 100% biventricular stimulation as the prerequisite for a beneficial therapeutic effect. In a important study by Knight et al it could be shown that in a population of 440 CRT-patients, 36% did not have continuous biventricular stimulation. The main cause was the occurrence of atrial tachyarrhythmias, in particular atrial fibrillation. The medical control of rapid ventricular conduction remains a difficult problem in heart failure patients. Furthermore it is unknown how many patients have good biventricular pacing under resting conditions but develop an improved AV-conduction with exercise. This can cause inhibition of ventricular stimulation or in many cases fusion beats. Conversely, an AV-interval programmed too short may have detrimental effects on diastolic filling times.

The safest method to control the ventricular rate and prevent ventricular fusion beats with a normal AV time is the AV node ablation using radiofrequency ablation.

The An Art Study investigates whether patients with an implanted CRT pacemaker or a CRT defibrillator will benefit from an AV-node-ablation using a combined symptomatic heart failure endpoint and duration of biventricular stimulation as compared to a CRT control group.


Eligibility Criteria:
Inclusion Criteria:

* All patients who had a CRT pacemaker or CRT-ICD implanted and who are under optimal medical therapy, can be included 3 months after implantation of the device.

Exclusion Criteria:

* The sole exclusion criterion is no consent of the patient.
A Nutritional Intervention for Migraines-2

The purpose of the study is to assess whether, in individuals with migraines, a low-fat, vegan diet improves pain more effectively than a control supplement or a placebo. The principal measures are pain as measured by Visual Analog Scale (VAS) and the change in migraines frequency. The study duration is 36 weeks.This study also tests that a low fat, plant-based (vegan) diet free of foods commonly identified as triggers improves mood, using the Center for Epidemiologic Studies Depression Scale-Revised (CESD-R), and the Beck Depression Inventory II (BDI-II).

Preliminary evidence suggests that low-fat, vegetarian diets and certain nutritional supplements can help reduce pain and also reduce the need for pain medications for some people. The investigators will ask about 100 people to participate. All of them will get a low-fat, vegan diet and a nutritional supplement (mixture of omega-3 oils and vitamin E or a placebo), although some will get the diet first, and others will get the supplement first. This order in which they will get the diet and the supplement will be determined randomly, that is, by chance (like the toss of a coin). The principal measures are pain as measured by Visual Analog Scale (VAS)and the change in migraines frequency.

Mood change will be measured using the Center for Epidemiologic Studies Depression Scale-Revised (CESD-R), and the Beck Depression Inventory II (BDI-II).

Eligibility Criteria:
Inclusion Criteria:

A diagnosis of migraine, as defined by the criteria of the second edition of the International Classification of Headache Disorders:

At least 5 attacks fulfilling criteria the criteria below:

* Headache attacks lasting 4-72 hours (untreated or unsuccessfully treated)
* Headache has at least two of the following characteristics:
* unilateral location
* pulsating quality
* moderate or severe pain intensity
* aggravation by or causing avoidance of routine physical activity (eg, walking or climbing stairs)
* During headache at least one of the following:
* nausea and/or vomiting
* photophobia and phonophobia Not attributed to another disorder
* Migraines occurring at least twice per month, on average.
* Age at least 18 years
* Ability and willingness to participate in all components of the study
* Willingness to be assigned to either the diet group or supplement group
* Migraine medications unchanged within last 6 weeks.

Exclusion Criteria:

* \< 18 years of age
* Alcohol consumption of more than 2 drinks per day or the equivalent, episodic increased drinking (e.g., more than 2 drinks per day on weekends), or a history of alcohol abuse or dependency followed by any current use
* Use of recreational drugs in the past 6 months (past drug use, if fully recovered, is not a criteria for exclusion)
* Pregnancy
* Unstable medical or psychiatric illness
* Likely to be disruptive in group sessions (as determined by research staff)
* Already following a low-fat, vegan diet
* Lack of English fluency
* Inability to maintain current medication regimen
* Inability or unwillingness to participate in all components of the study
Efficacy and Safety of Intranasal Morphine for Pain After Bunion Surgery

Study designed to evaluate the efficacy and safety of Intranasal (IN) Morphine Nasal Spray (MNS075) 3.75 mg, 7.5 mg, 15 mg, and 30 mg, intravenous (IV) morphine 7.5 mg, or IN placebo in patients with moderate to severe post-surgical pain following orthopedic surgery. After initial dosing, up to six (6) doses of IN MNS075 7.5 mg or 15 mg for up to twenty-four (24) hours will be evaluated. The rescue dose remained the same for each.

Diagnosis and Main Criteria for Inclusion:

Healthy adult patients (18 to 76 years old), who scored PS-1 to PS-3 according to the American Society of Anesthesiologists Physical Status Classification System, requiring primary, unilateral, first metatarsal bunionectomy surgery alone or with ipsilateral hammertoe repair without additional collateral procedures.

Eligibility Criteria:
Inclusion Criteria:

* Requires primary unilateral first metatarsal bunionectomy surgery alone or with ipsilateral hammertoe repair under regional anesthesia. The patient requires collateral orthopedic surgical procedures other than ipsilateral hammertoe repair may not be enrolled into the study.
* 18 years of age or older
* Moderate to severe pain within eight (8) hours following completion of the required bunionectomy surgery

Exclusion Criteria:

* Allergy to shellfish
* Signs of nasal congestion, nasal polyps, mucosal lesions of the nostrils, postnasal drip of any etiology or any clinically significant nasal pathology that may affect the absorption of study medication or the assessment of safety.
* Chronic respiratory insufficiency such that treatment with an opioid analgesic is contraindicated

Additional Inclusion/Exclusion Criteria May Apply
Tibolone Endometrium Study (Study 32972)(P06470)

Tibolone has been registered for the treatment of climacteric symptoms and for the prevention of postmenopausal osteoporosis. This is a 2-year study to further confirm the endometrial safety of tibolone in comparison with CE/MPA.


Eligibility Criteria:
Inclusion Criteria:

* Healthy postmenopausal women, 45 to 65 years of age with an intact uterus. Women must have been postmenopausal for less than 15 years, have an atrophic or inactive endometrium, and a body mass index of 18 - 32 kg/ m2 (inclusive).

Exclusion Criteria:

* Final diagnosis of the endometrial biopsy as 'no tissue' or 'tissue insufficient for diagnosis'.
* Double layer endometrial thickness \> 6 mm as assessed by transvaginal ultrasonography (TVUS).
* Any previous or current unopposed estrogen administration or tamoxifen citrate.
* Any unexplained vaginal bleeding following the menopause.
* Women with abnormal Pap smear test results (PAP IIb and higher)
* Previous use of raloxifene hydrochloride for longer than one month.
Carotid Intima-media Thickness (IMT) and Large-vessel Atherosclerosis by Multidetector Computed Tomography (MDCT)

The aim of this study was to investigate whether carotid IMT can predict the presence of more advanced atherosclerosis such as carotid stenosis, coronary or intracranial artery disease by MDCT and whether MDCT could be useful next step for more aggressive treatment modality in Korean type 2 diabetic patients.

We evaluated mean/maximal carotid IMT in seventy-one type 2 diabetic subjects, and defined increased carotid IMT as maximal IMT ≥ 1.0 mm. Multidetector CT (MDCT) and pulse wave velocity (PWV) were taken to evaluate carotid artery stenosis (CS), coronary artery disease (CAD), intracranial arterial lesion (ICA), and peripheral artery disease (PAD). We compared prevalence of large artery stenosis according to carotid IMT group and evaluated whether maximal IMT ≥ 1.0 mm could predict for significant CAD by MDCT. We performed invasive coronary angiography in some patients (N=14) and analyzed association for degrees of CAD between two angiographic methods.

Eligibility Criteria:
Inclusion Criteria:

* Type 2 diabetic patients who had multiple cardiovascular risk factors were recruited.
* Patients who had atypical chest pain, EKG abnormality (ischemic ST-T changes or abnormal Q-wave), or history of previous cardiovascular disease were also included.

Exclusion Criteria:

* Acute coronary SD, serum Cr\>1.4 mg/dL, history of allergy to iodinated contrast dye were excluded.
Early Coordinated Multidisciplinary Intervention to Prevent Sickness Absence and Labor Market Exclusion in Patients With Low Back Pain.

In Denmark the number of patients, sick listed for more than four weeks is increasing, and patients suffering from musculoskeletal disorders make one third of the total amount of long-term absenteeism. Compared to other diagnoses, patients suffering from musculoskeletal diseases, including low back pain, are less likely to return to work after a period of sick leave. It seems that a multidisciplinary intervention, including cooperation between the health sector, the social sector and in the work place, has a positive effect on days off work due to musculoskeletal disorders and particularly low back pain. The aim of this study is to evaluate the effect of a work oriented multidisciplinary intervention.

A randomized controlled trial will include 770 patients with low back pain. The study population consists of patients, who are sick listed or at risk of sick leave due to LBP.

The control group is treated with usual care in a team with participation of a physiotherapist, a chiropractor, a rheumatologist and a local employed social worker The Intervention group is treated with usual care and in addition intervention of a psychologist, an occupational physician, an ergonomist and a social worker from the local sickness benefit office. The treating physiotherapist will be the RTW-coordinator. Outcome will be reported at the end of treatment as well as 6 and 12 months follow up. The primary outcome is number of days of work. Secondary outcomes are disability, pain, and quality of life.

This large RCT study is testing the effectiveness of a preventive intervention targeting patients on short term sick leave or at risk being sick listed because of low back pain. We have developed a novel multidisciplinary team structure using the treating physiotherapist as the return to work coordinator, and having the case manager from the sickness benefit office participating in team meetings.


Eligibility Criteria:
Inclusion Criteria:

* Working age adults 18-65
* Low back pain (longer than 2 weeks)
* Sicklisted or at risk
* Employed or unemployed

Exclusion Criteria:

* Severe comorbidity
* Pregnancy
* Difficulties in reading Danish language
* Application for early retirement
Clinical Trial to Evaluate the Antihypertensive Effect of AGSCT101 in Patient With Hypertension

The purpose of this study is to evaluate the antihypertensive effect of AGSCT101 tablet in patient with stage 1 to 2 essential hypertension.

This study is 2,8 weeks, multi-center, randomized, double-blind, active clinical trial to evaluate the efficacy and safety of AGSCT101 versus Carvedilol in patient with stage 1 to 2 essential hypertension.

Eligibility Criteria:
Inclusion Criteria:

* Male or female outpatients ≥ 19 years of age
* Mild to moderate essential hypertension: sDBP 90 \~ 109, sSBP 140 \~ 179
* Subjects who agree to participate in this sudy and give written informed consent
* Subjects considered to understand the study, be cooperative, and able to be followed-up until the end of the study

Exclusion Criteria:

* The sitting DBP is more than 110mmHg or the sitting SBP over 180mmHg
* Patients with postural hypotension
* Patients with severe renal(Creatinine more 1.5mg/dl), gastrointestinal, hematological or hepatic(AST, ALT more 3 times more than upper limit of normal)disease
* Female of childbearing potential who does not undergo hysterectomy or is not post-menopausal
* Patients judged to have a history of alcohol or drug abuse by the investigator
* Patients with a history of myocardial infarction, severe coronary artery disease or clinically significant heart failure or valvular defect in last 6 months
* Patients with uncontrolled diabetes mellitus
* Patients participated other clinical trial 12 weeks before Screening Patients judged to be inappropriate for this study by the investigator with other reasons
Maximum Biting Force of Inject Able Thermoplastic Resin Versus Conventional Resin in Complete Denture Patients

In this research we are comparing the new thermoplastic material side by side with the conventional poly methyl methacrylate for fully edentulous patients measuring their maximum biting force whether it is going to be higher by the new polyamide material.

For all included patients and in the first visit, panoramic x ray is taken then a primary impression will be made for the maxillary and mandibular arches using irreversible hydrocolloid material. Then, the maxillary and mandibular impressions will be poured with a hard stone to get a study casts.

A double layer wax spaced self-cured acrylic resin will be used to prepare a special tray for each patient. The special tray using also irreversible hydrocolloid material makes a secondary impression. The secondary impressions will be poured using extra hard dental stone to get the master casts.

At this point the patient is given a number to enter one of the two groups either the intervention group or the control group.

For the intervention group, the framework of the thermoplastic resin is usually thicker than that of the metal. At this time the framework wax pattern will be ready for spruing and flasking using specially designed flasks. The injection of the thermoplastic resin will be started after the elimination of wax and the procedure will be done using thermopress machine.

In the third visit for all patients, the finished denture bases of thermoplastic resin will be tried inside the patient's mouth to check its fitting, retention, reciprocation and opposing occlusion.

Then, a face bow record will be taken for each patient which will be used to mount the maxillary cast on the articulator. For mounting the mandibular cast, either an intercuspal or centric jaw relation will be used. Artificial teeth will be set up and tried in in the patient's mouth in the fourth visit to check esthetics, phonetics, lip support, occlusion and uneven pairing.

In The fifth visit, the finished prosthesis will be adjusted and delivered to each patient, the outcome data will be collected using a questionnaire, and a salivary swap is taken for microbial count detection.

Complete dentures will be constructed for all patients; Group- I: patients will receive complete dentures from thermoplastic material Group- II: patients will receive complete dentures from conventional Poly methyl Methacrelate resin.

Then use Gnatho-dynamometer for measure the biting force for all patients

Eligibility Criteria:
Inclusion Criteria:

* - Completely edentulous
* No bone irregularities
* Good oral hygiene
* Should be co-operative
* Medically free
* No TMJ Problems

Exclusion Criteria:

* - Bone irregularities , soft tissue ulcerations , severe undercuts
* Serious systemic problem
* Patient with xerostomia
* Severely resorbed ridge
Lupine Allergy in Children

All children sensitized to lupine who have performed an oral food challenge (OFC) to lupine between January 2017 and May 2024 in the Pediatric Allergy Unit of the University Hospital of Nancy were included. Retrospective data regarding food and respiratory allergies were collected as well as information regarding lupine skin prick test (SPT), specific IgE (sIgE) and OFC. Severity of allergic reaction was evaluated by CoFAR grade and reactogenic cumulative threshold dose.

Aims of this study were (i) to assess relevance of sensitization to lupine in children and (ii) to describe severity of reactions in case of allergy.


Eligibility Criteria:
Inclusion Criteria:

* cutaneous or biological sensitization to lupine

Exclusion Criteria:

* oral food challenge done with something other than lupine flour
Anti-cancer Potentiality of Saffron Against Hepatocellular Carcinoma

Saffron has recently gained considerable interest for its capacity to interfere with cancer at initiation and promotion stages as well as for cancer treatment. Although saffron and its constituents have been shown to have antitumorigenic and proapoptotic activities in different cancer cell lines.

The aim of the current investigation is to identify the anti-cancer potentiality of saffron on hepatocellular carcinoma patients.

Hepatocellular carcinoma (HCC) is the fifth most common cancer and the third leading cause of cancer mortality in the world. Chronic infection with hepatitis B and C is the major risk factors for HCC worldwide. Other factors that contribute to the formation of HCC include exposure to environmental carcinogens, iron overload, fatty liver disease, and alcohol abuse.

there has been a sustained rise in its incidence in both developing and developed countries. Despite the growing therapeutic options for patients with cancer, their efficacy is time-limited and non-curative. Hence to overcome these drawbacks, an incessant screening for superior and safer drugs has been ongoing for numerous decades, resulting in the detection of anti-cancer properties of several phytochemicals. Chemoprevention using readily available natural substances from vegetables, fruits, herbs and spices is one of the significantly important approaches for cancer prevention in the present era. Among the spices, saffron has generated interest because pharmacological experiments have established numerous beneficial properties including radical scavenging, anti-mutagenic and immuno-modulating effects.

Saffron is a naturally derived plant product from the dried stigma of the Crocus sativus flower (family Iridaceae) that may have biologically useful properties. In fact, saffron extract and its biologically active compounds, including crocin, crocetin, carotene, and safranal, have been shown both in vitro and in vivo to possess antioxidant, anticancer, anti-inflammatory, and memory-improving properties. Saffron is also used in folk medicine as an antispasmodic, antidepressant, and aphrodisiac. Furthermore, it is one of the most commonly used species around the world for flavouring and colouring foods.

Saffron has recently gained considerable interest for its capacity to interfere with cancer at initiation and promotion stages as well as for cancer treatment. Although saffron and its constituents have been shown to have antitumorigenic and proapoptotic activities in different cancer cell lines.

Eligibility Criteria:
Inclusion Criteria:

* Adult male and female patients above 18 years
* Patients with end-stage HCC not candidate for curative, loco regional treatment and /or systemic chemotherapy
* Patients with available baseline laboratory parameters and contrast- enhancing images after given written consent for research participation.

Exclusion Criteria:

* Patients who are candidate for curative and/or loco-regional or combination treatment for HCC
* Patients with concomitant malignancies other than HCC
Growing Healthy Hearts: A Pilot Randomized Control Trial to Test Gardening as an Intervention to Improve Health

The purpose of this study is to test the effect of group-based nutrition advice plus gardening (intervention) versus group-based nutrition advice alone on dietary intake of fruits and vegetables, physical activity, and lifetime risk for cardiovascular disease (CVD).

Study participants will be randomly assigned to attend group sessions related to gardening with nutrition advice or nutrition advice alone. The main goal of the intervention will be to encourage participants to increase their intake of fruits and vegetables.

Eligibility Criteria:
Inclusion Criteria:

1. Are at least 20 years old
2. Have transportation and are willing to travel to the Hershey Community Garden
3. Have any two health conditions or risk factors for CVD. These include, but are not limited to:

   1. Any history of cardiovascular disease
   2. Any family history of premature cardiovascular disease
   3. Any history of stroke
   4. High cholesterol
   5. High blood pressure
   6. Overweight/obesity (BMI \>=25)
   7. Diabetes
   8. Current or past Tobacco use

Exclusion Criteria:

1. Currently tends a vegetable garden
2. Moving out of the area in the next 4 months
3. Non-English speaking
4. Pregnant women
5. Participation in a past gardening study
6. Medical conditions or medications that limit ability to freely increase dietary intake of fruits and vegetables (e.g., kidney failure, dialysis)
7. A medical condition that precludes safe pursuit of gardening, i.e., recent heart conditions (e.g., heart failure, stroke, heart attack), recent or pending surgery, severe orthopedic conditions, pending hip/knee replacement, paralysis, dementia, blindness, unstable angina or uncontrolled arrhythmias, or uncontrolled asthma or allergies.
8. History of difficulty obtaining blood samples or fear of needles
Prevalence of Intestinal Parasitic Infections in Patients With Irritable Bowel Syndrome

Irritable bowel syndrome (IBS) is common medical disorder and represent a group of diseases of the gastrointestinal tract that is characterized by chronic abdominal pain , bloating , passage of mucus or straining with bowel movements, sense of incomplete evacuation after bowel movements or sense of urgency to move the bowels.Several parasites including Entamoeba. histolytica, Giardia spp., Blastocystis. hominis, and Trichinella spp. have been discussed as contributing factors to the development of IBS.

B. hominis is one of the most common human intestinal protozoa in both developing and developed countries. some studies have reported a significant association between the parasitic infections, especially Blastocystis, and IBS.Cryptosporidium has been reported in IBS patients, with the onset of gastrointestinal symptoms after an acute episode of cryptosporidiosis despite recovery and parasite clearance.Numerous studies have been conducted to evaluate the association between the parasitic infections and IBS.

Aim of the work:

To detect prevalence of intestinal parasitic infections in irritable bowel syndrome patients in sohag.


Eligibility Criteria:
Inclusion Criteria:

* Patients complaining of symptoms of IBS, such as abdominal discomfort, diarrhea, and constipation, bloating with any age \& sex groups

Exclusion Criteria:

* Patients have celiac disease, gastrointestinal malignancies , inflammatory bowel disease , HIV , and those on immunosuppression and those who had been recently taking antibiotics within the previous four weeks and anti-parasitic drugs within the previous two weeks.