cyrilzakka/clinical-trials huggingface dataset:
Patient's Anastrozole Compliance to Therapy Programme

Approximately 60 specialised clinics and 420 office based gynaecologists or oncologists will participate in this in practice evaluation program (NIS). The clinic and approximately 7 office based physicians will collaborate within their breast centre networks to conduct this program. A breast centre network should be able to recruit in this program approximately 80 patients (approximately 40 patients per year). It is planned to enroll approximately 4674 patients in this NIS (2337 patients per arm). The patient population will include postmenopausal women with hormone-receptor positive primary breast cancer scheduled for upfront adjuvant endocrine treatment with anastrozole according to the current standard medical procedures.


Eligibility Criteria:
Inclusion Criteria:

* Histological/cytological confirmed primary diagnosis of early breast cancer
* Postmenopausal
* Hormone receptor positive

Exclusion Criteria:

* Patients with severe renal function disorders
* Patients with moderate or severe disorders of hepatic function
* Concomitant treatment with drugs known to affect sex hormonal status and tamoxifen
Effects of a Minimal-Contact Lifestyle Intervention on Physical Activity, Diet, and Body Weight

The purpose of this study is to conduct a pilot randomized controlled trial, to determine whether providing financial incentives for meeting daily step goals (a) increases the daily step counts of participants, (b) increases compliance with the overall program (including diet recommendations), and (c) increases weight loss.


Eligibility Criteria:
Inclusion Criteria:

* required to be able to read.
* required to have access to a computer.
* required to have a body mass index between 27 and 45 kg.m-2.
* required to take fewer than 7,000 steps per day at baseline (as determined by a pedometer, averaged across 4-7 days).

Exclusion Criteria:

* Individuals who report having an injury or physical limitation that renders them unable to walk ¼ mile without difficulty.
* Uncontrolled cardiovascular or metabolic condition determined by health history questionnaire.
Study Comparing the Safety and Efficacy of Tigecycline With Ampicillin-Sulbactam or Amoxicillin-Clavulanate to Treat Skin Infections

The purpose of this study is to compare the safety and efficacy of the antibiotic tigecycline with other antibiotics, ampicillin-sulbactam, and amoxicillin-clavulanate in the treatment of a complicated skin and/or skin structure infection (cSSSI).


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of complicated skin or skin structure infection
* Male or female, 18 years or older
* Need for intravenous treatment for 4 to 14 days

Exclusion Criteria:

* Skin infection that can be treated by surgery \& wound care alone
* Diabetic foot ulcers or bedsores where the infection is present longer than 1 week
* Poor circulation such that amputation of the infected site is likely within a month Other exclusions apply
Study of T900607-Sodium in Previously Treated Patients With Non-Hodgkin's Lymphoma.

The purpose of the study is to determine whether T900607-sodium is effective and safe in treating non-Hodgkin's lymphoma.


Eligibility Criteria:
Inclusion Criteria

* Histologically or cytologically confirmed diagnosis of non-Hodgkin's lymphoma (NHL)
* Subjects must have received prior chemotherapy for their NHL
* At least 18 years of age
* Bidimensionally measurable disease amenable to CT scanning. At least one lesion must be least 1 X 1 cm in size.
* Karnofsky performance status of at least 70%
* Estimated life expectancy of at least 12 weeks
* Females of childbearing potential must have a negative pregnancy test and agree to use an effective contraceptive
* Subject must be able to comply with study procedures and follow-up examinations.
* Signed written informed consent
* Lab Values (obtained ≤ 7 days prior to study enrollment):
* ANC at least 1.5x10e9/L,
* Platelet count at least 100x10e9/L,
* Hemoglobin at least 8.5 g/dL,
* Creatinine within 2 times upper limit of normal,
* AST and ALT within 3 times upper limit of normal,
* Bilirubin within 1.5 times upper limit of normal,
* Albumin great than 2.5 g/dL,

Exclusion Criteria

* Severe, concurrent disease, infection or co-morbidity that, in the judgment of the investigator, would make the subject inappropriate for enrollment
* NYHA Class III/IV cardiac disease, left ventricular ejection fraction (LVEF) of \<50%, or acute anginal symptoms
* Patients who have received any investigational agent within 4 weeks of enrollment
* Patients who are pregnant or breast-feeding
* History of prior malignancy other than NHL within the last 5 years, except for adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix
* History of central nervous system metastases or carcinomatous meningitis
* Major surgery within 4 weeks of enrollment
The Effect of Nature-based Exposure on the Immune System and Skin Health of Atopic Dermatitis Patients.

The purpose of the study is to explore the effect of nature-based exposure on immunological biomarkers and the condition and symptoms of atopic skin. Our hypothesis is that regular exposure to nature-based, high biodiversity material on skin, strengthens the skin's protective barrier and has a positive effect on the immunological biomarkers associated with atopic dermatitis. Further our hypothesis is that the difference between the groups (active and placebo) is noticeable during winter time when the disease is typically worse because of the cold weather. The study aim at scientific publication and is double-blinded and placebo-controlled. Time of the intervention is 6-7 months: intervention starts before the Finnish winter time and ends before the summer.


Eligibility Criteria:
Inclusion Criteria:

* A person aged 18-65, legally competent
* Meets Hanifin \& Rajka's criteria for atopic dermatitis in the initial interview and eczema has also appeared regularly in adulthood
* The possibility to commit to the research

Exclusion Criteria:

* Cancer or cancer treatments
* Medication that suppresses the immune system (excluding antihistamines)
* Systemic medicine intended for the treatment of atopic dermatitis (orally or as an injection, other than an antihistamine) or the use of clinical phototherapy in the last 6 months.
* Skin infection (such as a eczema that required antibiotic cream or a parasitic infection, e.g.scabies mite) during the last 6 months
* Atopic dermatitis that required hospitalization in the last 2 years
* Psoriasis or other skin disease affecting the study in addition to atopy
* Pregnancy or breastfeeding
The Impact of Diet Liberalization on Bowel Preparation for Colonoscopy

This study will evaluate the expansion of dietary options from clear liquids the entire day to a low reside breakfast and lunch for patients prior to undergoing bowel preparation with MoviPrep® and its effect on preparation quality for colonoscopy.

This study will evaluate the expansion of dietary options from clear liquids the entire day to a low reside breakfast and lunch for patients prior to undergoing bowel preparation with MoviPrep® and its effect on preparation quality for colonoscopy. MoviPrep® is a commercially available 2 liter bowel purgative for use before colonoscopy in adults 18 years of age or older that is comprised of polyethylene glycol-electrolyte solution (PEG-ELS) plus sodium sulfate, sodium ascorbate, and ascorbic acid.

Eligibility Criteria:
Inclusion Criteria:

* Elective outpatients \> 18 yrs undergoing colonoscopy

Exclusion Criteria:

* Unable or unwilling to give informed consent
* Age \< 18 years
* Pregnant
* Breast feeding
* Gastroparesis - established or suspected
* Pseudo-obstruction - established or suspected
* Severe constipation (\< 1 BM a week)
* Bowel obstruction
* Colon resection
* Chronic nausea or vomiting
* Known Glucose-6-Phosphate Dehydrogenase (G6PD) deficiency
* PEG allergy
* Significant psychiatric illness
PUFA Augmentation in Treatment of Major Depression

The purpose of this study is to determine if omega-3 fatty acid EPA will enhance and speed up response to antidepressant therapy with Celexa (Citalopram) in people suffering from Major Depressive Disorder. All patients will receive Celexa, 50% will receive EPA, 50% placebo EPA.

As per brief summary

Eligibility Criteria:
Inclusion Criteria:

* Meet DSM-IV criteria for current major depression, and have a HAM-D (21 item) score of \> 17
* Male or female who, if of child-bearing potential, agrees to use effective contraception including the regular use of contraceptive pills, intra-uterine devices, barrier methods or abstinence
* Age between 18 and 65
* Capable of giving informed consent

Exclusion Criteria:

* Diagnosis of schizophrenia, schizophreniform disorder, schizoaffective disorder, schizotypal disorder, psychotic depression or bipolar disorders
* Current drug or alcohol abuse or dependence, or history of drug or alcohol abuse or dependence within the previous 6 months
* Unstable medical or neurological conditions that are likely to interfere with the treatment of depression
* History of allergy to citalopram or ProEPA, finfish or shellfish
* History of failure of response to citalopram, as documented by an adequate trial of the medication \[defined as having been treated with the medication at a dose level typically regarded as adequate (i.e., 40 mg of citalopram per day) for at least 6 weeks\]
* History of seizure disorder
* Pregnancy
* Currently on psychotropic medications including antidepressants or neuroleptics
* Active suicidal ideation or other safety issues determined by the clinician to not be suitable for inclusion in the study
* Exposure to treatment with fluoxetine or MAOIs in the previous two months
* Patients on anticoagulant therapy
* Patients with a dietary intake of \> 3.0g total omega-3 PUFA/day at baseline
The Impact of Pack Supply on Birth Control Pill Continuation

The purpose of this study is to determine whether getting more packs of birth control pills leads to improved continuation, when compared with getting the traditional supply.

Discontinuation of oral contraceptive use in the initial months is common; successful early continuation is predictive of long term continuation and prevention of unintended pregnancy. The conventional approach to initiation of hormonal contraceptives in publicly funded clinics across the United States is to give the patient a limited supply of OCs, or a prescription with a limited number of refills, and then have her return to the clinic for a refill. This approach requires the patient to make frequent visits to the clinic, a barrier to method continuation.

This randomized trial will evaluate a simple but potentially powerful change in family planning clinic practice, i.e., the effect of dispensing more versus fewer cycles of oral contraception (OC). The study will be carried out in an urban, publicly funded family planning clinic that serves a population that is poor, young and primarily Hispanic or AfricanAmerican. This population was targeted as its members are at increased risk of discontinuing contraception in the ﬁrst year of use.

Eligibility Criteria:
Inclusion Criteria:

* English or Spanish speaker
* age less than or equal to 35 years requesting OC as their primary method of contraception
* currently sexually active or anticipating sexual activity within the next 30 days

Exclusion Criteria:

* contraindications to oral contraceptives per clinic protocol (e.g., hypertension and pregnancy)
* currently using OCs (that is, current users requesting a routine refill)
* desiring pregnancy within the next 6 months
* leaving the clinic catchment area within 6 months
* previous participation in this study
Sleep Apnea and Periodic Breathing

The purpose of this study is to determine the double loop index (DLI) threshold with optimal sensitivity and specificity. The investigators hypothesize that the DLI gives a better reflection of the pathophysiology of the disease than the apnea-hypopnea-index (AHI).

Sleep apnea syndrome (SAS) is characterized by repetitive events of apnea and hypopnea. These events are often part of a periodic breathing pattern, in which relative hyperventilation is followed by apnea or hypopnea.

Recently the investigators described the 'double-loop gain' of the respiratory control system as a measure of periodic breathing. This is a frequency-dependent variable which describes 1) the tendency of the respiratory system to oscillate at a given frequency and 2) the degree to which the relation between oscillations in ventilation and oscillations in arterial blood gas values is linear. The underlying hypothesis is that periodic breathing results from negative feedback regulation of arterial O2 and CO2 pressure through the chemoreflexes. The double-loop gain describes the gain in the negative feedback loop under the assumption that accidental changes occur in both ventilation and arterial blood gas pressures. A simple version of the double-loop gain is derived from nasal pressure changes and arterial O2 saturation. From all-night recordings, the 'double-loop index' (DLI) can be derived, which is determined by the time during which the double-loop gain exceeds a given threshold.

Currently, the presence of sleep-apnea is determined by the apnea-hypopnea index (AHI), using in-hospital sleep recording. With a growing number of referrals, waiting lists for sleep registration are emerging. Screening for SAS using home-measurement of nasal pressure and SaO2 seems to be a good alternative. The investigators hypothesize that the DLI derived from these signals gives a better reflection of the pathophysiology of the disease than the AHI. As a result, the investigators expect that the DLI improves the distinction between healthy and diseased subjects in comparison to the simple counting of apneas and hypopneas. This is reflected in a higher area under the ROC curve, which describes the sensitivity and specificity of the test.

Eligibility Criteria:
Inclusion Criteria:

* Suspected sleep apnea syndrome
* \> 18 yr
* Outpatient
* Able and willing to use the necessary equipment for registration of nasal pressure and O2 saturation at home

Exclusion Criteria:

* hospitalized patients
* \< 18 yr
* Not able to use the necessary equipment
The Performance of Posterior Partial Coverage Coronal Restorations Luted With Two Differrent Systems.

This study explores an alternative approach using a pre-heated restorative resin composite as a luting material of partial coverage restorations on upper and lower posterior teeth. It will follow a split-mouth design with 60 participants selected based on strict criteria. Assessment at 6 months and 1 year post-delivery utilizes a modified model of USPHS criteria, evaluating retention, color match, marginal discoloration, secondary caries, anatomical form, marginal adaptation, and surface roughness.

The null hypothesis:

The use of preheated resin composite for cementing partial coverage restoration will not result in significantly superior clinical performance when compared to that after using dual-cure resin cement.

The adhesive cementation of ceramic partial coverage restorations is a technique-sensitive process essential for achieving optimal retention and marginal integrity. While dental resin cements are commonly used for adhesive luting of indirect ceramic restorations, concerns exist regarding their long-term reliability due to susceptibility to degradation over time and polymerization shrinkage-related issues.

This study explores an alternative approach using a pre-heated restorative resin composite as a luting material of partial coverage restorations on upper and lower posterior teeth, aiming to address these drawbacks. It will follow a split-mouth design with 60 participants selected based on strict criteria. The preparation and delivery appointments follow specific guidelines, incorporating the Morphology Driven Preparation Technique (MDPT). Assessment at 6 months and 1 year post-delivery utilizes a modified model of USPHS criteria, evaluating retention, color match, marginal discoloration, secondary caries, anatomical form, marginal adaptation, and surface roughness.

The objectives of this clinical trial are to evaluate the clinical performance of posterior partial coverage coronal restorations utilizing two different luting systems (preheated resin-based composite versus conventional dual-cure resin cement) in a split-mouth study design.

Eligibility Criteria:
Inclusion Criteria:

* Consenting participants.
* Individuals aged 18 years and above with no systemic diseases that will affect their participation.
* Teeth of healthy periodontium.
* Teeth to be restored in normal occlusion with natural antagonist and adjacent teeth.
* Acceptable oral hygiene characterized by no gingivitis, calculus deposit or active carious lesions.
* Non-vital teeth will be included

Exclusion Criteria:

* Heavy occlusal contacts or signs of bruxism.
* Profound, chronic periodontitis
* Poor oral hygiene.
* Sustained dentin hypersensitivity.
* Systemic disease or severe medical complications or taking anti-inflammatory, analgesic, or psychotropic drugs.
Circulating Tumor Cells (CTCs) in Advanced Gastric Cancer

To assess the predictive value of circulating tumor cells (CTCs) for recurrence of advanced gastric cancer after radical resection.

To identify the relationship between the detection of circulation tumor cells and recurrence patterns of gastric cancer after radical resection.


Eligibility Criteria:
Inclusion Criteria:

* Having signed informed consent
* Age≥ 18 years old
* Histologically confirmed gastric adenocarcinoma
* Preoperative clinical examination and imaging indicating operable disease
* complete resection (R0 resection)
* D2 or D2+ resection

Exclusion Criteria:

* Other tumor type than adenocarcinoma
* Patients who have been given preoperative chemotherapy/chemoradiation.
* Staging investigations or intraoperative exploration indicating inoperable disease
* R1 or R2 resection
* D0 or D1 resection
* Patients unreliable for follow up
* Past history of malignancy
Investigation of the Effectiveness of Upper Limb Exercise in COPD Patients

The aim of the study is to investigate the efficacy of upper limb exercise training in Chronic Obstructive Pulmonary Disease (COPD) patients. For the purpose of the study, a controlled trial will be conducted within Respiratory Clinic of Nicosia General Hospital. The sample will be divided in two groups. The intervention group will participate in a pulmonary rehabilitation program which includes upper and lower extremities exercises, with addition of arm ergometer. The second group (control group) will participate in the same program but without arm ergometer training.

The study's hypothesis is that the intervention group will improve the outcome measures significantly better than the control group.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of COPD confirmed by clinical examination and a pulmonary function test
* Stable clinical condition (without recent respiratory system infections or any exacerbation of the disease)
* Patients must be willing to re evaluate at the end of the study
* Patients must be willing to give written consent for their participation in the study

Exclusion Criteria:

* Age \< 18 years old
* Unstable cardiac disease
* Musculoskeletal and neurological diseases that could affect exercise performance or preclude exercise
* Patients of COPD final stage or other serious disease final stage
* Significant cognitive or psychiatric impairment that would lead to an inability to follow simple commands in a group setting
Quality of Life Assessment in Patients Undergoing Prolonged Suppressive Antibiotherapy for Prosthetic Joint Infection.

Prosthetic joint infection (PJI) management is complex and requires prosthesis replacement when symptoms duration is greater than 30 days or debridement with modular set replacement when symptoms duration is lesser than one month. Nevertheless, the prolonged suppressive antibiotherapy (PSA) is the single treatment we can provide to high risk surgical patients and those who refuse reoperation.

There is limited data available on PSA modality, its tolerance and efficacy, this lack of data motivated us to concept a prospective study of long term patient follow up with PJI treated with prolonged suppressive antibiotherapy.

Main objective:

Quality of life assessment of patients undergoing prolonged suppressive antibiotherapy for PJI.

Secondary objectives:

1. Depressive symptoms assessment in patients undergoing prolonged suppressive antibiotherapy for PJI.
2. Functional assessment in patients undergoing prolonged suppressive antibiotherapy for PJI.
3. Evaluation of PSA side effects
4. Evaluation of nutritional status
5. Evaluation of of PSA termination criteria

Methods:

The follow up oh this cohort will be conducted using 3 questionaries related to quality of life, joint stiffness and depressive symptoms.

Study type:

This is a study of health care procedure, evaluating the quality of life of patients undergoing prolonged suppressive antibiotherapy for PJI.

Sample size: all patients cared by our referral center of bone and joint infection, who meet protocol selection criteria will be included in the study, thus we are expecting to recruit 60 patients.

Study duration: 6 years.

Recruitment period: 4 years.

Maximal duration of data collection: 2 years.

Investigator center: Single center study.

Mean patient inclusion per year: 15 patients per year.

Eligibility Criteria:
Inclusion Criteria:

* Patient aged over 18 years old with hip or knee prosthetic infection who consented to participate in the study
* Non-eligible patient to surgical treatment
* Patient eligible to prolonged suppressive antibiotherapy

Exclusion Criteria:

* patient who does not meet eligibility criteria
* Patient living or traveling abroad for whom 2 years minimum follow up is impossible.
* Patient lawfully deprived of his liberty
* Patient not insured under social security scheme
A Study of Tamiflu (Oseltamivir) for Seasonal Prophylaxis of Influenza in Children.

This study will evaluate the safety of Tamiflu, when used for the prevention of influenza in children during the flu season. Children who would benefit from influenza prophylaxis when influenza is circulating in the community will receive treatment with Tamiflu syrup (or capsules) 30mg-75mg once daily (dependent on body weight) for 6 weeks. Safety data and influenza symptoms will be recorded throughout the study. The anticipated time on study treatment is \<3 months, and the target sample size is \<100 individuals.


Eligibility Criteria:
Inclusion Criteria:

* males or females, 1-12 years of age;
* candidate for seasonal prophylaxis;
* negative rapid diagnostic test for influenza at baseline.

Exclusion Criteria:

* symptoms suggestive of influenza-like illness;
* positive rapid diagnostic test for influenza;
* antiviral treatment for influenza in 2 weeks prior to randomization.
Pressure Controlled Ventilation Versus Volume Controlled Ventilation in Upper Abdominal Surgery

Comparison of mechanical powers produced at volume controlled and pressure controlled mechanical ventilation

The mechanical power created by mechanical ventilation, as a new concept, can enable to evaluate the effect of different components in the lung.Our aim in this study is to calculate mechanical power in different ventilation modes ( pressure controlled and volume controlled ventilation) and to compare them. To calculate the mechanical powers we will use Van der Meijden's mechanical power formula for pressure controlled ventilation and for volume controlled ventilation we will use Gattinoni's mechanical power formula. In the literature we haven't seen any publication comparing the mechanical power of two commonly used ventilation modes (volume controlled and pressure controlled ventilation)

Eligibility Criteria:
Inclusion Criteria:

* ASA1-2 , \>18 years old patients having upper abdominal surgery

Exclusion Criteria:

* chronic obstructive lung disease, interstitial lung disease
* chronic renal failure
* Child-Pugh \> 6 liver disease
* Patients who don't give consent
* NYHA \> 2 heart failure