cyrilzakka/clinical-trials huggingface dataset:
Endometrial Preparation by Short Course of Letrozole Before Hysteroscopic Removal of Endocavitary Lesions

The aim of this study is to evaluate the effectiveness of short course of letrozole for endometrial preparation before hysteroscopic surgery for intracavitary lesions.

In the cycle subsequent to hysteroscopic identification of an endouteine pathology, patients who fitted with the inclusion criteria will be randomly divided into two groups; letrozole group (study group) and placebo group (control group). The randomization will be a stratified randomization with permuted blocking (the block size is randomly permuted among 2, 4, and 6) within each stratum. The only stratification variable will be by type of endouterine pathology. The randomization will be balanced (using a 1:1 treatment ratio) and will be carried out by a nurse through sealed, unlabeled, opaque envelopes containing computer-generated random numbers. The study will be double-blind (the participants, caregivers and investigators will be blinded to block size and group assignment).

Women in the letrozole group will be treated with letrozole (5 mg daily) for 10 days before hysteroscopic intervention while women in the placebo group will be treated with placebo for 10 days before hysteroscopic intervention in the early follicular phase of a natural cycle. In both groups, monopolar hysteroscopic surgery with glycine (1.5%) as uterine distension media will be used. Precise records of the duration of each surgical procedure, from the insertion to the removal of the resectoscope will be done.

Measurements of inflow, outflow, and amount of distension liquid absorbed by the patient will be taken meticulously. Intraoperative bleeding will be defined as "light" when bleeding does not interfere with surgery, "moderate" when bleeding required the coagulation of vessels, and "severe" when hemorrhage required immediate suspension of hysteroscopy. At the end of surgery, surgeon satisfaction with endometrial preparation using Visual Analogue Scale (VAS) and quality of visualization of the uterine cavity will be compared. Postoperative complications will be defined as the appearance of any complications occurring from the termination of the surgery to discharge.

Eligibility Criteria:
Inclusion Criteria:

* Patients with endouterine pathologies, identified by office diagnostic hysteroscopy during the early endometrial proliferative phase (cycle days 7 to 8)

Exclusion Criteria:

* Presence of large submucous (type I, type II) or endocavitary (type 0) fibroids (according to the European Society of Hysteroscopy Classification of Submucous Fibroids) with a diameter exceeding 4 cm, for which preoperative treatment with GnRH agonists is indicated.
* Hormonal therapies in the previous 8 weeks (including the drug of the study).
* Uterine and/or concomitant adnexal pathologies (including malignancy) for which hysteroscopic surgery was not considered either safe or the method to resolve the problem.
* Cardiovascular, hepatic, or renal impairment.
* Allergy to letrozole.
Optimization of Drug Prescriptions in the Care Pathway for the Elderly, With the Final Objective of Reducing the Iatrogenic Risk

The IATROPREV project is an organizational innovation experimentation project, carried out in Hauts-de-France by the University hospitals of Amiens and Lille, the ARS and the URPS Doctors and Pharmacists of Hauts-de-France and following to the social security financing law of 2018, allowing experimentation with new organizations in the health sector, according to article 51. The objectives of this course are to improve the relevance of prescription in elderly people with multiple drugs as well as, the coordination of care between the city and the hospital through the sharing of information and the establishment of multi-professional consultations between the various care actors.


Eligibility Criteria:
Inclusion Criteria:

* patient hospitalized in the geriatric medicine department
* Potential involvement of a drug in hospitalization or potential or proven iatrogenic event during hospitalization;
* Numerous therapeutic modifications (3 or more);
* Drug interaction or introction of a new drug with one or more drug interactions;
* Medicinal product with a narrow therapeutic marge drug requiring close monitoring.

Exclusion Criteria:

* patient non hospitalized in the geriatric medicine department
Thoracic Hyperkyphosis and Low Back Pain

This study was conducted on forty male patients (15 in the control group and 25 in the study group)) with low back pain hyperkyphosis of the thoracic spine, ages ranged from 20 - 40 years old. The visual analogue scale, the Oswestry disability questionnaire, and Cobb's angle was assessed for all patients before any intervention and two months post-intervention.

This study was conducted on 40 male patients aged 20 to 40 suffering from LBP. Patients were included in the study if they had hyperkyphosis with an X-ray cobb's angle greater than 40 degrees. The visual analogue scale (VAS), the Oswestry disability questionnaire (ODI), and Cobb's angle were assessed for all patients before and one month post-intervention. Patients who met the inclusion criteria and agreed to participate in this study were randomly assigned to one of the two groups. Group 1 (the control group) received the usual care for the lumbar spine which includes TENS, ultrasound, and myofascial release for the lumbar spine in addition to a core program including bridge, half bridge and clam shell exercise. Group 2 (the study group) received the triple attack protocol which includes a modified P-A mobilization, manipulation, and stabilization program (Active and passive) for the thoracic spine in addition to the usual care and the core program for the lumbar spine

Eligibility Criteria:
Inclusion Criteria:

* patients who has low back pain due to facet joint arthropathy or discogenic cause confirmrd by MRI. Chronic spine instability confirmed by clinical tests. Sacroiliac joint confirmed by claster of lattelets. Hyperkyphosis (\>40 degree measured by cobb's angle)

Exclusion Criteria:

* any structural deformity (wedge fracture) or previous spinal surgeries. Spinal tumors or fracture or presence of active infection in the lumbar spine. Systematic disorder (Rheumatoid) Cauda equine lesion, the presence of any comorbidities such as hypertension, DM, hyperlipidemia, obesity, and any autoimmune disease, history of patients who suffered from cancer, unexplained weight loss, immunosuppression, prolonged use of steroids, intravenous drug use, urinary tract infection, pain that is increased or unrelieved by rest, fever, significant trauma related to age, bladder or bowel incontinence, urinary retention (with overflow incontinence), saddle anesthesia, loss of anal sphincter tone, major motor weakness in lower extremities, fever, and vertebral tenderness.
Validation of the eNutri Food Frequency Questionnaire for Adults Aged 65 y and Older

The aim is to determine whether the eNutri web application can effectively estimate the dietary intake of a UK older population. The eNutri FFQ65+ study will validate the eNutri online food frequency questionnaire (FFQ) using 100 adults aged 65+ years. The FFQ will be validated against an online 24-hour dietary recall system (Intake24) and its reproducibility will be evaluated by the completion of two FFQs within a 14-day interval. In addition, all participants will also be asked to provide dried blood spot (DBS) samples which will be analysed for key biomarkers of nutritional intake and health. Biomarker results will be compared to FFQ results to further validate the eNutri FFQ.

The primary objective of this study is to validate the eNutri FFQ65+ that assesses dietary intake for the previous 4 weeks against a widely-used, validated computer based 24-hour dietary recall system (Intake24), which is the dietary assessment tool currently used by the UK's National Diet and Nutrition Survey Rolling Programme. The second objective, the reproducibility of the FFQ 65+ dietary data, will also be tested by asking participants to complete the eNutri FFQ on two separate occasions with a 14-day interval between both. In addition, after completing the first FFQ, DBS will be collected from all participants to further validate the FFQ results against selected biomarkers, for example markers of nutrient intake, such as carotenoids, and markers of health, such as cholesterol.

Eligibility Criteria:
Inclusion Criteria:

* Aged 65 years or over
* Live in the UK
* Able to spend approximately 30 minutes using a screen on a device
* Do not have a diagnosis of dementia or another condition affecting memory
* Do not have a food allergy or food intolerance (self- or medically diagnosed)
* Are not following a weight loss diet
* Generally eat on 2 or more occasions everyday

Exclusion Criteria:

* Follow a specialised or restricted diet (not including vegan and vegetarian diets)
* Have a medical condition or take medications that do not allow an individual to eat a stable diet on a day-to-day basis (e.g. severe gastrointestinal condition)
* Anticipate changes to their diet within the next three weeks (e.g. surgery, holiday, receiving nutritional advice from a professional)
* Have participated in another nutrition study that included a specific dietary regime in the last 4 weeks or are currently participating
Spinal Versus General Anesthesia for Laparoscopic Cholecystectomy

The aim of this study is to compare early postoperative outcomes of unselected consecutive patients underwent laparoscopic cholecystectomy (LC) under spinal versus general anesthesia.

Laparoscopic cholecystectomy (LC) is the gold standard surgical treatment of symptomatic cholecystectomy which traditionally performed under general anesthesia. Laparoscopy has provided many advantages over open surgery for the patients; however, general anesthesia adversely affects patients' early postoperative quality of life (POQoL).

Spinal anesthesia which is a less invasive technique compared to general anesthesia has many advantages regarding the POQoL such as no need to wait for recovery from anesthesia, less nausea and vomiting, less or no pain at the end of surgery, no discomfort associated with intubation, early ambulation, fully awaken and oriented patient in the bed, and less anxious relatives.

LC has been shown to be feasible under spinal anesthesia if performed with proper technique. There are many reports demonstrated the effectiveness and safety of LC under spinal anesthesia in selected patients. However, patients with complicated gallstone disease such as acute, gangrenous or subacute cholecystitis have been considered as unfit cases for LC under spinal anesthesia because of technical difficulties. On the other hand, spinal anesthesia has also been regarded as inappropriate for patients complying with American society for anesthesiology (ASA) III and IV due to the uncontrolled anesthesia risks.

The aim of this study is to compare early postoperative outcomes of unselected consecutive patients underwent LC under spinal versus general anesthesia. If proportion of general anesthesia (PGA) / proportion of spinal anesthesia (PSA) denotes the proportion rate of outcomes in the general anesthesia group (GaG) / spinal anesthesia group (SaG), then two-sided test problem is assessed as follow:

1. Null hypothesis: H0: PGA = PSA. There is no difference between the two anesthesia techniques in terms of primary outcomes.
2. Null hypothesis: H1: PGA ≠ PSA There is a difference between the two anesthesia techniques in terms of primary outcomes.

Eligibility Criteria:
Inclusion Criteria:

* All patients who underwent laparoscopic cholecystectomy for symptomatic gallstone disease with no restriction for age, gender, ethnicity, disease severity, and ASA grade.

Exclusion Criteria:

* Patients were excluded if they underwent concurrent surgeries, had malignancy suspicion, received or converted to open surgery, and patients who were under spinal anesthesia converted to general anesthesia.
Deflox Tablets Bioequivalence (BE) Trial

The purpose of this study was to demonstrate the bioequivalence of Deflox® 50 milligrams (mg) tablets compared with Cataflam® DD tablets 50 mg administered as single dose in fasting conditions to healthy participants.


Eligibility Criteria:
Inclusion Criteria:

* Participants who have a body weight within 55-95 kilograms (kg) and body mass index (BMI) within the range 18.0-27.0 kilogram/meter square (kg/m2) (inclusive)
* Participant has given written informed consent before any study-related activities are carried out - Participants with ethnic origin: Mexicans (example: Caucasians, Indigenous peoples and Mestizos) - No smoking
* Participants with good physical and mental health status, determined on the basis of the medical history and a physical examination
* All values for biochemistry and hematology tests of blood and urine within the normal range or showing no clinically relevant deviation as judged by the Investigator
* Other protocol defined inclusion criteria could apply

Exclusion Criteria:

* Participants with any surgical or medical condition, including findings in the medical history or in the pre-study assessments, or any other significant disease, that in the opinion of the investigator, constitutes a risk or a contraindication for the participation of the participant in the study or that could interfere with the study objectives, conduct or evaluation
* Participants with history of surgery of the gastrointestinal tract which could influence the gastrointestinal absorption and/or motility according to the Investigator's opinion
* Participants with allergy: ascertained or presumptive hypersensitivity to the active drug substance and/or formulations' ingredients; history of anaphylaxis to drugs or allergic reactions in general, which the Investigator considers may affect the outcome of the trial
* A subpopulation of participants with asthma may have aspirin-sensitive asthma, which may include chronic rhinosinusitis complicated by nasal polyps; severe, potentially fatal bronchospasm; and/or intolerance to aspirin and other nonsteroidal anti-inflammatory drugs (NSAIDs). Because cross-reactivity between aspirin and other NSAIDs has been report in such aspirin-sensitive patients, Cataflam is contraindicated in patients with this form of aspirin sensitivity
* Receipt of any prescription or non-prescription medication within 2 weeks before the first study drug administration, including multivitamins and herbal products (example: St John's Wort), including acetylsalicylic acid (ASA), and hormonal contraceptives in females
* Participants with renal failure or renal dysfunction (creatinine clearance \< 80 milliliter per minute \[mL/min\]) as assessed by using the estimated measure with the Cockcroft-Gault formula
* Other protocol defined exclusion criteria could apply
Reactogenicity, Immunogenicity and Inflammatory Response by New COVID-19 Vaccine Platforms

Analysis of humoral antibody and cytokine kinetics after vaccination with either BNT162b2 or ChAdOx1 nCoV-19 vaccine and factors influencing the vaccine immunogenicity

There is a different aspect of reactogenicity between BNT162b2 and ChAdOx1 nCoV-19 vaccine. Both new platform vaccines were concerned if they would elicit more significant local or systemic reactogenicity compared to the conventional vaccines. Previous studies had reported that immune cells such as mast cells and macrophages are activated just after vaccination, and release proinflammatory cytokines such as interleukin (IL)-6 and tumor necrosis factor (TNF)-α. The post-vaccination kinetics of inflammatory cytokines would be variable by each vaccine platform, and might be associated with reactogenicity. It is an interesting issue to be investigated whether the reactogenicity following newly developed BNT162b2 and ChAdOx1 would be associated with immunogenicity and inflammatory response or not. To better clarify these uncertainties, we evaluated the change of antibody response between BNT162b2 and ChAdOx1 over three months post-vaccination, in relation to the kinetics of inflammatory cytokines and reactogenicity.

Eligibility Criteria:
Inclusion Criteria:

* Volunteers who provide the informed consent after either BNT162b2 or ChAdOx1 vaccination
* healthy adults without underlying medical condition

Exclusion Criteria:

* Volunteers who had ever infected with SARS-CoV2 were excluded.
Long Term Social Assistance Recipient in South Eastern Sweden - a Description of Health, Function, and Activity

There is a group of social assistance recipients which have difficulties in entering the labor market and thus remains in a long-term dependency on social assistance. More knowledge about individuals receiving long-term social assistance is needed in order to improve into work interventions for this group. Therefore, this study aims to describe variables of health, function and activity in participants receiving long-term social assistance.

There is a group of social assistance recipients who have difficulties in entering the labor market and thus remains in a long-term dependency on social assistance. More knowledge about individuals receiving long-term social assistance is needed in order to improve into-work interventions for this group. Therefore, this study aims to describe variables of health, function and activity in participants receiving long-term social assistance. Individuals who have received social assistance during more than three years, who report physical and/or psychological difficulties, and/or have a complex social situation will be asked for participation in a six months activity-based investigation including contact with social worker, psychologist, occupational therapist, physical therapist and labor market consultant. The intervention aims to clarify the participants hinders and resources for entering the labor market. The participants are going to answer a questionnaire about health, function, and activity before and after the investigation. In addition, the participants function and ability to perform activities will be classified using the International Classification of Functioning (ICF). Data from the questionnaires and from ICF recordings will be used to describe variables of health, function and ability to be active. Participants who manage to get closer to, or enter into, the labor market will be asked to participate in a qualitative interview study about the experiences of the change. In addition, social workers will be asked to participate in focus-group interviews about experiences from the professional contact and work with the participants. The quantitative data will be analysed using traditional statistics and multivariate data analysis. Qualitative data will be analysed using qualitative content analysis.

Eligibility Criteria:
Inclusion Criteria:

* Long-term social assistance recipient (more than three years)
* Putative ill-health (physical, psychological and/or social)
* No present plan how to reach the labor market
* Need of clarifying the working ability

Exclusion Criteria:

* Homelessness
* Severe psychiatric illness
* Abuse of alcohol or substances
Cerebrovascular Correlates of Dementia in Rural Communities - The Three Villages Study

This study aims to assess the prevalence and severity of dementia in an established cohort of community-dwelling older adults living in three neighboring rural Ecuadorian villages (Atahualpa, El Tambo, and Prosperidad), as well as to evaluate clinical and neuroimaging correlates of dementia in the study population. By the use of the Clinical Dementia Rating Scale (CDRS), the study also aims to assess the lower cutoff of the MoCA that better correlates with the occurrence of dementia in the study population. In addition, this study will provides grounds for the initiation of a prospective cohort study to assess factors influencing the development of dementia in the follow-up.

The Three Villages Study is a population-based prospective cohort study designed to reduce the increasing burden of cognitive decline and dementia in rural Ecuador. Before the study, our Executive Committee met with community leaders to explain the aims of the study and to learn about the culture and traditions of villagers. Field personnel were trained to assure uniformity in data collection. With the aid of satellite view (Google Earth, Google Inc., Mountain View, CA), updated sketches of the villages were performed to identify blocks and houses.

The study initially will follow a 3-Phase cross-sectional design. During Phase I, Atahualpa, El Tambo, and Prosperidad residents aged 60 years or more will be identified by means of a door-to-door survey and interviewed with validated questionnaires to identify those with relevant risk factors and suspected conditions of interest. In Phase II, certified neurologists will examine suspected cases as well as random samples of negative individuals, to assess reliability of field instruments and to determine prevalence of the investigated conditions. In Phase III, enrolled individuals will be invited to undergo complementary tests. Thereafter, incoming residents will be recruited and followed-up by means of yearly door-to-door surveys and other overlapping sources to estimate incidence of the disorders of interest.

Eligibility Criteria:
Inclusion Criteria: Individuals aged 60 years of more residing in Atahualpa, El Tambo, and Prosperidad, who signed a comprehensive informed consent form.

-

Exclusion Criteria: Severely disabled individuals in whom interviews and procedures cannot be performed

-
Hypnosis in Interventional Electrophysiology

Hypnosis has already shown to decrease pain and anxiety in different surgical specialities. Nevertheless, its input has never been studied in cardiology. This research is a prospective, monocentric, controlled and randomized study.

Patients over 18 years old and hospitalized for atrial flutter ablation may be included and randomized into one of the arms: placebo or hypnosis.

Global pain will be assessed by a visual analogue pain scale. Anxiety, morphine consumption, and patient sedation will also be assessed.

The aim of this study is to improve the care given to patient undergoing atrial flutter ablation.


Eligibility Criteria:
Inclusion Criteria:

* Over 18 years old
* Surgery ablation of atrial flutter
* Agreement to participate of the study

Exclusion Criteria:

* Person who does not speak French or deaf
* Chronic pain with the visual analogue scale \> 5
* Psychiatric pathology
* Contraindication to paracetamol, lidocaine, morphine
* Pregnant women, or breast-feeding women or without effective contraception
Fast Food Feeding in Youth

The primary aim of the proposed pilot study is to assess the effects of fast food meals, varying in serving size and rate of delivery, on energy (calorie) intake in adolescents.

Using a three-period crossover design, the investigators will evaluate three acute feeding conditions.

* Under Condition A, the total amount of food in a large fast food meal will be delivered on a single tray at Time 0 (start of meal).
* Under Condition B, the same fast food meal will be equally divided among 4 separate portions, with all portions delivered at Time 0.
* Under Condition C, the meal again will be equally divided among 4 separate portions, but the portions will be delivered at 15-minute time intervals (Time 0, 15 minutes, 30 minutes, 45 minutes).

Eligibility Criteria:
Inclusion Criteria:

* Body mass index (BMI) between the 85th and 98th percentiles for sex and age
* Consumption of fast food at least one time per week
* Willingness to eat the foods specified in the research methods
* Parent/guardian willing and able to cooperate
* Access to a working telephone

Exclusion Criteria:

* Major medical illness (eg, diabetes; heart, renal, or liver disease; cancer; endocrinopathy)
* Taking any prescription medication that may affect food intake
* Current smoking (i.e., any tobacco in the last month)
* Previous diagnosis of an eating disorder