cyrilzakka/clinical-trials huggingface dataset:
Letrozole Step-up Protocol for Ovulation Induction in Infertile Women With PCOS

the aim of the study is to compare between the step-up and conventional protocols in ovulation induction in infertile women with PCOS

The current study was conducted in private outpatient clinic after being approved by the medical ethics committee. The study is a prospective randomized study consisting of 90 Egyptian patients diagnosed as having infertility with pcos .

Sample size determination:

Group sample sizes of 42 and 42 achieve 80% power based on study finding carried out by (Galal et al., 2014) to detect a difference of 0.7 between the null hypothesis that both group means are 2.2 and the alternative hypothesis that the mean of group 2 is 1.5 with known group standard deviations of 1.5 and 0.6 and with a significance level (alpha) of 0.05000 using a two-sided Mann-Whitney test assuming that the actual distribution is uniform.

Sample size was calculated by PASS 11 Computer program for sample size calculation.

Taking into consideration 10% drop out rate, the sample size will be increased to 45 patients in group I and another 45 patients in group II.

Patients were divided into two groups with randomization sheet:

Group (I): includes 45 females taking Letrozole (old regimen).

Group (II): includes 45 females taking Letrozole 5 mg tab in a step-up protocol (new regimen).

Eligibility Criteria:
Inclusion Criteria:

* Age: 20 -37 years old.
* No conception for at least one year.
* Diagnosis of PCO as established by Rotterdam criteria, endometriosis diagnosed by laparoscope or unexplained infertility.

Exclusion Criteria:

* Age \< 20 and \> 35 years old.
* Uterine pathology e.g. fibroid or ovarian cyst.
* Hyperprolactinemia, hypo or hyperthyroidism.
* Impaired hepatic or renal function.
* History of hypersensitivity to study drugs.
A Personalized Behavioral Intervention to Improve Physical Activity, Sleep and Cognition in Sedentary Older Adults

Cognitive decline and sleep complaints are prevalent in older adults and severely affect older adults' physical health and quality of life. Sedentary lifestyle, which is reported by 90% of older Americans, is an important risk factor for both cognitive decline and sleep disturbances. Although promoting physical activity has benefits to older adults' health, including sleep and cognition, traditional interventions to increase activity are challenging due to extensive staffing requirements and low adherence. Electronic activity monitors, such as wrist-worn accelerometers, can track heart rate, activity, and sleep to allow individuals to work towards personal activity and sleep goals. These appealing features make these devices ideal for interventions that aim to change behaviors and improve health outcomes. However, the efficacy of using electronic activity monitors to promote physical activity and health in older adults has not been examined.

The investigators will conduct a randomized controlled trial in a cohort of older adults (without dementia) with both sedentary lifestyle and nocturnal sleep complaints to examine the effectiveness of a personalized behavioral intervention (compared to a control group) embedded within a smart watch application in older adults. 94 cognitively intact elders and 21 older adults with mild cognitive impairment will be enrolled and randomly allocated to the intervention or control group. Participants in the intervention arm will receive in person exercise training sessions, and personalized, self-monitor physical activity, receive interactive prompts, biweekly phone consultation with the research team, and financial incentives for achieving weekly physical activity goals. The control group will receive general education on physical activity in older adults and continue the routine daily activity during the intervention period. The intervention for older adults without cognitive impairment is 24 weeks and for older adults with mild cognitive impairment is 16 weeks.


Eligibility Criteria:
Inclusion Criteria:

* Intact cognition or mild cognitive impairment
* Poor sleep quality
* Approval from healthcare provider to engage in mild to moderate physical activity
* More than 5 hours of self-reported sedentary time per day
* Understands English

Exclusion Criteria:

* Untreated sleep apnea as diagnosed by polysomnography
Coordinating Center: Natural History of Barrett's Esophagus Using Tethered Capsule Endomicroscopy

The goal of this research is to follow Barrett's Esophagus patients for 3 years using the tethered capsule endomicroscopy device with distal scanning and a compact imaging system in a multi-site clinical study.

The progression of Barrett's Esophagus will be studied over time using tethered capsule endomicroscopy imaging and will be performed at 5 different clinical centers in the US, namely: Massachusetts General Hospital (MGH),(MA), Mayo Clinic Jacksonville (FL), Mayo Clinic Rochester (MN), Columbia University Medical Center (NY), Kansas City VA Medical Center (MO). MGH will be the coordinating center of this multicenter study. Dr G. Tearney will serve as study Sponsor Investigator.

The purpose of this study is to determine the natural history of Barrett's Esophagus using TCE in subjects diagnosed with Barrett's Esophagus and undergoing surveillance endoscopy.

Eligibility Criteria:
Inclusion Criteria:

* Subjects over the age of 18
* Subjects who are capable of giving informed consent
* Subjects with a diagnosis of BE without high grade dysplasia, intramucosal adenocarcinoma or esophageal adenocarcinoma, confirmed by endoscopic biopsy,
* Subjects who had or will have a standard of care EGD within 15 months
* Subjects must have no solid food for at least 4 hours prior to the procedure, and only clear liquids for 2 hours prior to the procedure

Exclusion Criteria:

* Subjects with prior endoscopic ablation or resection treatment of BE at enrollment visit
* Subjects with esophageal fistula and/or esophageal strictures
* Subjects with the inability to swallow capsules
* Self reported pregnancy
Peri-operative Vitamin D Therapy for Hepatectomy

The goal of this double-blind, randomized controlled trial is to test the effect of short-term and high-dose vitamin D therapy in patients undergoing hepatectomy for hepatocellular carcinoma.

Participants will receive short-term high dose of vitamin D during perioperative period.

The main questions the study aims to answer are:

1. If vitamin D therapy benefits perioperative care
2. If short-term high dose of vitamin D supplement is safe

Eligibility Criteria:
Inclusion Criteria:

* Patients older than 20 years
* Patients will undergo hepatectomy for hepatocellular carcinoma.

Exclusion Criteria:

* Patients with hypercalcemia, hyperparathyroidism, sarcoidosis, multiple myeloma
A Study to Evaluate the Safety and Efficacy of Lotemax Ophthalmic Suspension 0.5%

The objective of this study is to identify any adverse events or adverse drug reactions through post-marketing surveillance under routine clinical practice

The objective of this study is to identify any adverse events or adverse drug reactions through post-marketing surveillance under routine clinical practice after marketing authorization of Lotemax ophthalmic suspension 0.5%

Eligibility Criteria:
Inclusion Criteria:

* Subjects who have been treated with the study drug at least once and completed safety follow-up.
* Subjects who have been treated with the study drug at least once and completed the clinical efficacy assessment.

Exclusion Criteria:

* Subjects not treated with study drug at least once.
UC-MSCs in the Treatment of Severe and Critical COVID-19 Patients

The goal of this randomized, controlled, open-labeled interventional clinical trial is to test the efficacy and safety of umbilical cord mesenchymal stem cells (UC-MSCs) in the treatment of severe and critical COVID-19 patients. The main questions it aims to answer are: 1. The efficacy of UC-MSCs in the treatment of severe and critical COVID-19 patients. 2. The safety of UC-MSCs in the treatment of severe and critical COVID-19 patients. 3. The potential immune mechanisms of UC-MSCs in the treatment of severe and critical COVID-19 patients. Participants will receive standard therapy, Paxlovid treatment or the UC-MSCs treatment. For the standard treatment, it will be conducted according the 9th edition of Chinese guidelines for COVID-19 infection. For UC-MSCs treatment, participants will be given UC-MSCs instillation at the first and fourth day after assignment. Blood examples will be taken at indicated time for arterial blood gas analysis and other tests. And participants should also objectively report their symptoms change and other information related to the treatment as listed the research protocol.


Eligibility Criteria:
Inclusion Criteria:

* The age ranges from 18 to 75 (inclusive), regardless of gender.
* Patients diagnosed with severe and critical COVID-19 pneumonia within one week, according to the Chinese diagnostic criteria for COVID-19 pneumonia in the Diagnosis and Treatment Plan for COVID-19 Pneumonia (Tentative Ninth Edition).
* 20kg/m2≤body mass index（BMI）≤30 kg/m2.
* Volunteer to participate in this clinical study and sign the written informed consent.

Exclusion Criteria:

* Those who are using immunosuppressive drugs or long-term immunosuppressive drugs after organ transplantation.
* T lymphocyte abnormality (allogeneic may be considered, depending on clinical opinion), HIV positive.
* Highly allergic or have a history of severe allergy, especially Interleukin-2 allergy.
* Pregnant and lactating women.
* Patients with severe autoimmune disease history; Allergies to all biological reagents in this treatment, such as Interleukin-2.
* Patients with serious complications, including chronic cardiac insufficiency (NYHA cardiac function grading assessment of cardiac function grade III - IV), chronic renal insufficiency (CKD stage 3 and above); Chronic liver insufficiency (Child-Pugh score\>7); Patients with malignant tumors.
* Patients with pulmonary embolism or acute coronary syndrome.
* Patients with severe organ dysfunction caused by other diseases.
* There are other situations that the researcher thinks are not suitable to participate in this clinical study.
Bivalirudin with Prolonged Infusion During PCI Versus Heparin After Fibrinolytic Therapy

This multicenter, randomized controlled trial in China aims to enroll 2,400 patients with ST-segment elevation myocardial infarction undergoing percutaneous coronary intervention (PCI) within 24 hours post-fibrinolysis. Participants will be randomly assigned in a 1:1 ratio to receive either bivalirudin or heparin, with follow-up at 30 days and 1 year. The primary endpoint is a composite of all-cause mortality and Bleeding Academic Research Consortium (BARC) type 3 or 5 bleeding at 30 days.

Bivalirudin is a direct thrombin inhibitor that exhibits a reversible and transient anticoagulant effect. Randomized trials have shown conflicting results for bivalirudin in reducing the risk of bleeding for ST-segment elevation myocardial infarction (STEMI) patients undergoing primary PCI (PPCI) compared to heparin. Recently, the BRIGHT-4 study, which assigned 6016 STEMI patients to bivalirudin with a prolonged high dose infusion or heparin during PPCI, showed bivalirudin decreased the risk of a composite endpoint of all-cause mortality and bleeding. However, few studies have focused on the safety and efficacy of bivalirudin in PCI post-fibrinolysis. We therefore aim to conduct the Bivalirudin With Prolonged Infusion During PCI Versus Heparin Following Fibrinolytic Therapy (BRIGHT-FIT) trial to examine whether bivalirudin with a high-dose infusion in PCI after fibrinolysis in superior to heparin in reducing mortality and major bleeding.

Eligibility Criteria:
Inclusion Criteria:

* Any age
* STEMI patients received fibrinolysis therapy within 12h of symptom onset and are planned to undergo PCI within 24h of symptom onset.
* Dual antiplatelet drugs must be administrated according to guidelines before PCI (loading doses and maintenance doses of aspirin and clopidogrel or ticagrelor)
* Patients requiring staged revascularization of non-culprit vessels within 30 days may be enrolled. In such cases the same antithrombotic agents and PCI procedures must be used in the staged procedure consistent with the index procedure PCI, in particular the assigned antithrombin agent heparin vs. bivalirudin);
* The subject or legal representative has been informed of the nature of the study, understood the provisions of the protocol, was able to ensure adherence, and signed informed consent.

Exclusion Criteria:

* Not suitable for PCI;
* Mechanical complications (such as ventricular septal rupture, papillary muscle rupture with acute mitral regurgitation, etc.);
* Cardiogenic shock(Killip IV)
* Known allergy or contraindications to heparin, bivalirudin, aspirin, or both clopidogrel and ticagrelor
* Patients who underwent PCI in past 30 days
* Patients in whom the investigators consider inappropriate to participate in this study (eg, have participated in another drug/instrument study or undergoing another drug/instrument study, pregnancy).
QoLiCOL - Quality of Life in Colon Cancer

All patients presenting at participating hospitals during the recruitment period with a newly diagnosed colon cancer, regardless of stage and planned treatment, will be eligible for inclusion. They will answer a questionnaire on health related quality of life, physical symptoms, functional impairments and socioeconomic status at diagnosis and after 12, 36 months. Clinical data including recurrence, survival, surgical treatment, oncologic result (pathology report) and adjuvant treatment will be collected from the Swedish ColoRectal Cancer Registry (SCRCR)

QoLiCOL is an explorative, prospective, longitudinal, non-interventional, international, multicenter study of health-related quality of life, physical symptoms, functional impairments and socioeconomic burden in colon cancer patients. All patients presenting at participating hospitals during the recruitment period with a newly diagnosed rectal cancer, regardless of stage and planned treatment, will be eligible for inclusion. Patients will be followed for 3 years. They will be asked to answer questionnaires at three different time points during follow-up: at diagnosis and after 12 and 36 months. Clinical data, including recurrence, surgical treatment, oncologic result (pathology report) and adjuvant treatment will be collected from the national quality registry for rectal cancer in Denmark and Sweden. As these registries differ in some areas between the countries, additional data will be collected through short CRF:s.

Eligibility Criteria:
Inclusion Criteria:

* Colon cancer newly diagnosed.
* Planned treatment presented

Exclusion Criteria:

* No Colon cancer diagnosis,
* below 18 years of age,
* no informed consent or withdrawn informed consent.
My Health eSnapshot - A Preconception Health Research Study

The purpose of the research is to identify the prevalence of preconception health (PCH) risk factors in the Wellington-Dufferin-Guelph (WDG) catchment area and to determine whether or not a client-driven electronic preconception health risk assessment tool "My Health eSnapshot", for use during healthcare visits, will increase preconception health knowledge and behaviour change among women of reproductive age (15-49 years).

The purpose of the project is:

1. To develop a client-driven electronic preconception health client risk assessment tool for use in a primary care setting.
2. To develop a customized key message handout for patients based on their risk assessment results.
3. To determine a successful and sustainable process for healthcare providers (HCPs) to administer the risk assessment tool and discuss results with patients within their primary care setting.
4. To increase participants' knowledge of preconception health and their risk factors as a results of the risk assessment tool and discussion with their HCP.
5. To modify participants' health behaviours as a result of the risk assessment tool and discussion with their HCP.
6. To increase WDG Public Health's understanding of the most prevalent preconception health risk factors among reproductive women in WDG.

Eligibility Criteria:
Inclusion Criteria:

* Women of reproductive age (15-49 years)
* Not pregnant and have not had a hysterectomy
* A resident of the Wellington-Dufferin-Guelph catchment area
* Able to read and write in English
* Have a valid email address
* Willing to create a unique identifier code during the study to protect their identify
* Are comfortable using a tablet

Exclusion Criteria:

-
Genicular Nerve Block for Total Knee Arthroplasty

This study seeks to examine the analgesic efficacy of genicular nerve blocks for pain after total knee replacement.

Part of the way in which pain is controlled during total knee replacement surgery is through a nerve block. The investigators have developed an effective protocol for pain control after knee replacement, but know that many patients still experience pain around the knee after knee replacement. There are nerves around the knee that carry pain impulses from behind the knee. The investigators believe that placing numbing medicine around these nerves can help with pain in front of the knee after surgery, in addition to the standard nerve block placed for knee replacement surgery. This may result in taking less pain medication by mouth,and having less pain with movement. For this study, before the operation, either a placebo solution or the local anesthetic bupivacaine (a numbing solution) will be placed at three sites around the knee where these nerves reside. The investigators will evaluate how participants feel in recovery after surgery, during the stay in the hospital, and call at home one week after surgery. Knowing if numbing these nerves helps with pain after surgery will help us further refine our postoperative care plan for patients.

Eligibility Criteria:
Inclusion Criteria:

* Subjects scheduled for primary elective total knee arthroplasty
* American Society of Anesthesiologists Physical Status I-III
* BMI 18-40 kg/m2

Exclusion Criteria:

* Inability to cooperate with protocol
* Inability to understand or speak English
* Allergy to ropivacaine, bupivacaine or other local anesthetic
* Contraindication to peripheral nerve block (e.g. local infection, neurologic deficit or disorder, previous trauma or surgery to ipsilateral knee, etc.)
* Revision knee surgery
* Chronic opioid consumption (daily morphine equivalent of \>30 mg for at least four weeks prior to surgery)
* History of chronic pain
* History of psychiatric disorder
* History of diabetes mellitus
Characterizing the EEG Signature of Fentanyl and Its Association with Drug Liking

The goal of this study is to characterize an electroencephalogram (EEG) biomarker for fentanyl and understand where this signal is coming from in the brain. We also aim to understand how this EEG biomarker is connected to patient perception to drug liking.


Eligibility Criteria:
Inclusion Criteria:

1. 18 years old or above (male and female)
2. American Society of Anesthesiologists (ASA) physical status classification of I, II or III
3. Candidates scheduled for general surgical procedures under general anesthesia and receive fentanyl for surgery

Exclusion Criteria:

1. Craniofacial abnormalities
2. Known or suspected difficult intubation or mask ventilation
3. Known or suspected need for rapid sequence induction and intubation
4. Body mass index above 45 kg/m2
5. Allergies to fentanyl
6. History of obstructive sleep apnea requiring CPAP
7. History of obstructive or restrictive lung disease
8. Opiate use within 24 hours
9. History of opiate abuse within the last 3 years
10. Known or suspected severe chronic pain condition that require use of opiates or limit daily activities
11. MRI contraindications, such as presence of pacemakers, aneurysm clips, artificial heart valves, ear implants, metal fragments, or foreign objects in the eyes, skin, or body
Evaluating of the Impact of a Connected and Non-intrusive Device in Improving the Screening of Sleep Apnea Syndrome and the Addressing of Potentially Pathological Patients in Hospital Environment

Diabetes, obesity and metabolic syndrome are closely linked to sleep apnea syndrome. Indeed, diabetic and/or obese patients present an increased risk of sleep apnoea syndrome (SAS), with a prevalence estimated at between 10 and 22%, depending on the study, and most of them requiring treatment with Continuous Positive Airway Pressure (CPAP). In this sub-population of patients, only between 40% and 50% benefit from CPAP.

There is therefore an under-referral of diabetic patients to treatment, perhaps linked to the way care is organized, which clogs up the circuit and slows down or even prevents access to care. The investigators would like to test a new organization of care to facilitate and intensify this screening.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients over 18 years old
* Diabetes Mellitus (Type 1 or 2), or obesity (BMI\>30kg/m²) or metabolic syndrome
* Hospitalized for at least one night in the Endocrinology department
* Affiliated or entitled to a social security scheme
* Having received informed information about the study and having co-signed, with the investigator, the informed consent form for participation in the study

Exclusion Criteria:

* Known and/or treated OSAS-type respiratory pathology
* No signature of the informed consent form
* Minor or adult patients under guardianship or curatorship
Deep Brain Stimulation on Dual-task Gait Performance in PD

Parkinson's disease (PD) is the second most common neurodegenerative disease after Alzheimer's disease. Motor symptoms include rigidity, bradykinesia, tremor, and postural instability, these motor symptoms can cause gait dysfunction. Non-motor symptoms include depression, dysarthria, cognitive disability, and sleep disturbance. Although these symptoms can be improved through drug treatment, when the course of PD reaches the middle to late stage, it will still face the situation of weakened drug efficacy and the drug side effects increased. When medication can no longer adequately control the motor symptoms of PD, deep brain stimulation (DBS) becomes a powerful option. DBS is a surgical treatment that involves implanting one or more electrodes into specific areas of the brain, which deliver electrical stimulation to regulate or destroy abnormal neural signal patterns in the target area. The effect of DBS has been proven whether it is in improving motor-related symptoms or non-motor-related symptoms, but there are still some areas that have not been compared before and after the surgery, such as: gait variability, executive functions and dual-task walking. In addition, the parameters of electrical stimulation for DBS will also affect the clinical characteristics of patients. Due to the large difference between individual cases, the recommendation of the electrical stimulation frequency still not be established. Therefore, the influence of DBS and its parameters on the symptoms of PD is a topic worthy of discussion. Purposes: (1) To investigate the long-term effects of DBS on the symptoms of PD. (2) To investigate the effects of DBS stimulation frequencies on walking performance and executive function in individuals with PD.


Eligibility Criteria:
Inclusion Criteria:

* Idiopathic PD
* Age: 50\~80 yrs old
* Hoehn and Yahr stage ≤ IV after DBS operation
* Implanted DBS system for at least 6 months
* MMSE ≥24

Exclusion Criteria:

* Other neurological disorders
* Any major systemic, psychiatric, visual, and musculoskeletal disturbances or other causes of walking inability