cyrilzakka/clinical-trials huggingface dataset:
Sexual Functioning in Endometrial Cancer

The purpose of this study is estimate how sexual function in endometrial cancer survivors varies with severity of disease.


Eligibility Criteria:
Inclusion Criteria:

* History of Stage I-IIIA endometrial adenocarcinoma of any grade
* 1-5 years out from primary surgical treatment
* Adjuvant therapy may only have consisted of radiation or hormonal therapy
* No evidence of disease

Exclusion Criteria:

* Previous treatment for other malignancies
* Did not undergo surgery for primary treatment of endometrial cancer
* Inability to read, write and speak fluent English
* Major cognitive impairment affecting ability to provide consent
Smoking Relapse Prevention Among COPD Ex-smokers

A placebo-controlled trial to determine whether recent ex-smokers with COPD who successfully stop smoking after taking varenicline are less likely to relapse back to smoking if they continue using varenicline for a further 12 weeks

Smoking remains the leading cause of Chronic Obstructive Pulmonary Disease (COPD), a leading cause of death and disability in New Zealand. COPD particularly affects indigenous Māori and Pacific people, given their higher rates of smoking. COPD patients tend to have a higher level of nicotine dependence and, as a result, often find quitting harder and are more likely to relapse back to smoking. A clinical trial (N=262) is planned in Auckland, New Zealand to determine whether extended varenicline treatment combined with behavioural support can prevent relapse back to smoking in recent ex-smokers with COPD. Smoking cessation and relapse prevention are the most cost-effective interventions available for COPD patients that smoke, irrespective of their disease stage. The trial has the potential to significantly improve the outcomes of this common and chronic health condition in New Zealand.

Eligibility Criteria:
Inclusion Criteria:

* Daily smokers
* Diagnosed with COPD (as per the Global Initiative for Chronic Obstructive Lung Disease \[GOLD\] criteria, namely: a characteristic clinical picture of dyspnea, cough or sputum, with a history of exposure to risk factors, plus a post-bronchodilator forced expiratory volume in one second / forced vital capacity FEV1/FVC ratio of \<0.70)
* Have stable COPD (i.e. no exacerbation, hospital admission, or use of antibiotics or prednisone in the past six weeks)
* Can provide consent
* Reside in the Auckland region of New Zealand
* Eligible under New Zealand special authority to receive subsidised varenicline
* Prepared to make a quit attempt with varenicline
* Have access to a phone

Exclusion Criteria:

* A history of definite asthma and/or atopy
* Contraindications to varenicline
* Used varenicline in the past 12 months
* A history of serious psychiatric illness or significant cognitive impairment
* Major or uncontrolled co-morbidities (such as uncontrolled heart failure, infection or rapidly progressive condition)
* A life expectancy of \< 12 months
* Are currently using another cessation medication (including e-cigarettes)
The Effect of Strenuous Exercise on Coagulation.

Many studies have shown that vigorous exercise increases the risk of developing vascular thrombotic events and can result in sudden death during or immediately after exercise. The outcome of these studies is biased by several confounding variables: subjects, type of exercise, duration, intensity and especially the method used for the evaluation of the hemostatic capacity. The goal of our study is to investigate the effect of strenuous exercise with the Calibrated Automated Thrombogram (CAT) assay, which is an established tool in detecting hyper- and hypocoagulabilty conditions. We modified the CAT assay to make it also feasible to measure TG in whole blood (WB-CAT), not only to go one step closer to physiology since all the blood cells are present, but also to avoid the centrifugation step. With our study we would like to see whether the other blood cells also play a role in the increase in TG. The objective is to investigate the effect of strenuous exercise (participation to the Amstel Gold Race) on coagulation and haemostatic parameters. We hypothesize that strenuous exercise induces a prothrombotic phenotype and that especially the tests involving blood cells will be altered into a prothrombotic phenotype.


Eligibility Criteria:
Inclusion Criteria:

* Healthy subjects not taking any medication interfering with coagulation that are willing to donate 18 ml of blood via venipuncture and a capillary blood drop via fingerpuncture before and after the Amstel Gold Race.
* Between 18 and 50 years of age. We take 50 year as a maximal age to prevent any co-morbidity that could have an influence on coagulation (like diabetes, atherosclerosis, peripheral arterial disease, ...).

Exclusion Criteria:

* Subjects taking any medication interfering with coagulation.
* Subjects having a cardiovascular disease or any other serious medical problem.
* Subjects below 18 years or above 50 years of age.
* Subjects that smoke.
Molecular Epidemiology of Lymphoma Patients

Primary Objectives:

1. To enroll and obtain, through questionnaires, risk factor information on all study participants to develop detailed demographic, epidemiologic and behavioral profiles.
2. To assess the influence of relevant epidemiologic covariates such as age, gender, smoking and family history of cancer on the panel of susceptibility biomarkers.
3. To evaluate the role of genomic instability in development of lymphomas.

This study will include individuals diagnosed with lymphoma and individuals with no history of cancer. Half of the participants in this study will have lymphoma, and half will have no history of cancer. Information from both groups will be compared to help researchers try to learn which factors may lead to the development of lymphoma.

If you agree to take part in this study, you will be asked to complete a questionnaire at M. D. Anderson. In this questionnaire, you will be asked about your demographics (such as your age, sex, etc.), certain environmental exposures (such as pollution), your medical history, family history, diet, and your past and present smoking and alcohol use habits. This questionnaire should take about 50 minutes to complete.

You will also have about 2 ½ tablespoons of blood drawn for special tests. These tests will look for any biologic factors (such as changes in your DNA) that may be linked to lymphoma. You will not be informed of the results of any of the testing done with your blood samples.

Your participation will be over in this study once your blood has been drawn.

This is an investigational study. Up to 800 participants will take part in this study. All will be enrolled at M. D. Anderson.

Eligibility Criteria:
Inclusion Criteria:

1. Cases only: Newly diagnosed, previously untreated patients with lymphoma as the primary cancer.
2. Age 18 years and older.
3. Willing to donate 30ml of blood.
4. Willing to complete a self-administered questionnaire.
5. Controls only: No prior cancer.

Exclusion Criteria:

1. Cases only: Prior history of cancer other than lymphoma.
2. Unable to speak or read English
Supplementation With Human Chorionic Gonadotropin (hCG) During Controlled Ovarian Stimulation With Recombinant Follicle-stimulating Hormone (FSH) for In Vitro Fertilisation

The purpose of this trial is to study whether addition of different doses of human chorionic gonadotropins during controlled ovarian stimulation for patients undergoing IVF will improve the number of top-quality embryos.


Eligibility Criteria:
Inclusion Criteria:

1. Females with indication for COS and IVF;
2. Age between 25-37 years;
3. BMI \>18 and \< 30 kg/m2;
4. A regular menstrual cycle between 24 and 35 days and presumed to be ovulatory;
5. Two ovaries;
6. Tubal or unexplained infertility, including endometriosis stage I/II;
7. A uterus consistent with expected normal function (e.g. no clinically interfering uterine fibroids) documented by transvaginal ultrasound at the screening;
8. Male partner with sperm quality compatible with fertilization via IVF procedure or previous clinical pregnancy;
9. Early follicular phase serum FSH levels of 1-12 IU/l;
10. Early follicular phase total antral follicle (2-10mm) count ≥ 6;
11. Confirmation of down-regulation before randomisation by transvaginal ultrasound;
12. Willing and able to sign informed consent.

Exclusion Criteria:

1. History of or current PCOS, endometriosis stage III/IV or severe male factor requiring ICSI;
2. History of severe ovarian hyperstimulation syndrome (OHSS);
3. Presence of unilateral or bilateral hydrosalpinx at ultrasound;
4. More than three previously COS cycles;
5. Previous poor response on an IVF-cycle, defined as \>20 days of gonadotrophin stimulation, cancellation due to limited follicular response or less than four follicles of ³15 mm diameter;
6. Previous IVF cycle with unsuccessful fertilization, defined as fertilisation of £20% of the retrieved oocytes;
7. History of recurrent miscarriage;
8. FSH\>12IU/L or LH\>12UI/L (early follicular phase);
9. Contraindications for the use of gonadotropins or GnRH analogues;
10. Recent history of current epilepsy, HIV infection, diabetes or cardiovascular gastrointestinal, hepatic, renal or pulmonary disease;
11. Pregnancy, lactation or contraindication to pregnancy;
12. Current past (last 12 months) abuse of alcohol or drugs;
13. History of chemotherapy (except for gestational conditions) of radiotherapy;
14. Undiagnosed vaginal bleeding;
15. Tumours of the ovary, breast, adrenal gland, pituitary or hypothalamus and malformation of sexual organs incompatible with pregnancy;
16. Abnormal karyotyping of the patient (if karyotyping is performed);
17. Hypersensitivity to any trial product.
Metreleptin in Anorexia Nervosa

The treatment of anorexia nervosa often proves to be difficult. There are no drugs that work specifically for the treatment of anorexia nervosa. Experimental administration of metreleptin (synthetically produced leptin) to patients with anorexia nervosa has produced positive results. This study tests the effect of metreleptin in comparison with placebo, which could potentially make treatment easier. The aim of the study is to investigate whether treatment with metreleptin can help to reduce the symptoms of anorexia nervosa and improve mood and weight.

Anorexia nervosa (AN) mainly affects young people, especially young women. AN is one of the most lethal psychiatric disorders. Treatment often proves to be very difficult, and AN course is frequently chronic. Specific pharmacological therapies for AN are lacking. Recent studies have shown that metabolic alterations play a great role in the etiology and pathogenesis of AN. An important metabolic alteration playing a role in the etiology and pathogenesis of AN is the hormone leptin. Patients with AN show hypoleptinemia. The role of hypoleptinemia in the neuroendocrine adaptation to starvation seems to induce emotional, cognitive, and behavioral symptoms of AN. From a theoretical point of view, pharmacotherapy augmenting leptin levels in patients with AN have a great therapeutic potential. Recently, positive effects with experimental administration of subcutaneous metreleptin in few young patients with severe AN have been observed. Importantly, no side effects have been observed. For all these reasons, the present study will investigate - with a double blind design - the therapeutic effect of metreleptin in patients with AN. Metreleptin will be administrated to 50 AN-inpatients: 25 patients will receive verum and 25 will receive placebo during 14 days. Primary objectives of this study are the amelioration of mood and weight. Secondary objectives are the investigation of functional brain connectivity, AN symptoms, as well as hematologic, blood chemistry and neuroendocrinological hormones.

Eligibility Criteria:
Inclusion Criteria:

* Current diagnosis of AN according to fifth edition of the Diagnostic and Statistical Manual of Mental Disorders (DSM-5) diagnosed with Structured Clinical Interview for DSM-5 (SCID-5)
* BMI \> 13 kg/m2; BMI ≤ 17.5 kg/m2; body weight \> 35 kg
* Hospitalisation in the Eating Disorders Unit, Department of Consultation-Liaison Psychiatry and Psychosomatic Medicine, University Hospital of Zurich
* Ability to understand German language- Age range: 18 - 40 years
* Depressive symptoms: HAMD-17 ≥ 8
* Negative pregnancy test, non-lactating and double birth control
* Informed Consent as documented by signature

Exclusion Criteria:

* Illicit drug intake within last month; current alcohol use disorder
* Severe psychiatric and/or severe somatic comorbidities; f. e. lifetime diagnosis of schizophrenia, bipolar disorder, inflammatory bowel disorders, diabetes mellitus, autoimmune disorders, pancreatitis, neurological disorders, cancer including lymphoma
* Acute suicidality or current serious non-suicidal self-injury
Turkish Version of the Glaucoma Quality of Life-15 Questionnaire

Glaucoma is a disease with irreversible loss of visual field and optic neuropathy and is the most important cause of irreversible vision loss after cataract in the world. Although clinical evaluations reveal the level of glaucoma quantitatively, it is necessary to evaluate the impact of this pathology on daily functions and quality of life with a holistic perspective and to provide appropriate advice to patients according to the information obtained. Glaucoma Quality of Life -15 Questionnaire (GQoL-15) was developed by Nelson et al. in 2003 to evaluate the quality of life of glaucoma patients. The aim of this study is to translate GQoL-15 into Turkish and evaluate its test-retest reliability for Turkish-speaking population.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of primary open angle glaucoma more than 6 months with visual field tests,
* Have the sufficient cognitive level to answer the scale questions.

Exclusion Criteria:

* To have retinal or optic nerve pathologies that may cause loss of visual field or decrease in visual field except glaucoma,
* To undergo eye surgery in the last 3 months.
Nurse-Led Interprofessional Mental Health Promotion Intervention for Older Home Care Clients

Objective: The objective of this study is to evaluate the feasibility, acceptability and effectiveness of a 6-month nurse-led, interprofessional mental health promotion intervention aimed at older home care clients with depressive symptoms using personal support services.

Methods/Design: This one-group pre-test post-test study aims to recruit a total of 250 long-stay (\> 60 days) home care clients, 70 years or older, with depressive symptoms who are receiving personal support services through a home care program in Ontario, Canada. The nurse-led intervention is a multi-faceted 6-month program led by a Registered Nurse that involves regular home visits, monthly case conferences, and evidence-based assessment and management of depression using an interprofessional approach. The primary outcome is the change in severity of depressive symptoms from baseline to 6 months using the Centre for Epidemiological Studies in Depression Scale. Secondary outcomes include changes in the prevalence of depressive symptoms and anxiety, health-related quality of life, cognitive function, and the rate and appropriateness of depression treatment from baseline to 12 months. Changes in the costs of use of health services will be assessed from a societal perspective.


Eligibility Criteria:
Inclusion Criteria:

* long-stay (\> 60 days) home care clients
* 70 years or older
* newly referred to and receiving PSS through the CCAC
* living in the community (not in a long-term care home)
* mentally competent to give informed consent (or with a substitute decision-maker available)
* competent in English (or with an interpreter available)
* screens positive for depressive symptoms

Exclusion Criteria:

* receiving palliative care services
* not competent in English and no interpreter available
* not mentally competent to give informed consent and no substitute decision-maker available
Study of Usefulness of Fluorescence in Thiroid Surgery

In thyroid surgery, the identification and preservation of the parathyroid glands and their vascularization is essential to avoid postoperative hypoparathyroidism. In this sense, fluorescence technology with autofluorescence (AF) can help us avoid this post-surgical complication. This study aims to determine the advantages offered by fluorescence in thyroid surgery, taking into account various clinical variables.

For this, a randomized study is proposed in patients undergoing thyroid surgery with and without cervical fluorescence.


Eligibility Criteria:
Inclusion Criteria:

* Total thyroidectomy with/without lymph node dissection
* Signature of informed consent

Exclusion Criteria:

* Patients under 18 years of age
* Hemithyroidectomy
* Reintervention of thyroid surgery
The Use of Breath Volatile Organic Compounds in Early Detection of Acute Pulmonary Exacerbations in Cystic Fibrosis

This is a single-centre, prospective observational cohort study assessing the potential utility of the Owlstone Medical "Breath Biopsy" in early diagnosis of pulmonary infections in patients with cystic fibrosis (CF). In cystic fibrosis pulmonary infections occur frequently and are associated with decline in lung function and disease progression, therefore a cornerstone of CF management is early identification and treatment of infections. "Breath Biopsy" is a non-invasive novel technology that has been trialled extensively in diagnosis of a variety of medical conditions with promising results. The technology is based the identification of a unique profile of organic compounds in exhaled breath of patients with a certain medical condition. Making the diagnosis of pulmonary infections in patients with CF is clinically challenging and at present relies on imprecise diagnostic tests, and generally requires attendance of patients to hospital or clinic for assessment. Ultimately, this research aims to assess the feasibility of incorporating "Breath Biopsy" into this diagnostic pathway with the advantages of both improving diagnostic certainty and potentially allowing in-home diagnosis of infections related to CF. Furthermore, identification of organic compounds implicated in CF infections will improve the understanding of why these infections occur, which to date remains an area that is poorly understood. Five patients with CF-related pulmonary infections admitted to the inpatient CF unit at the Royal Papworth Hospital will be enrolled, and use "Breath Biopsy" devices provided by Owlstone medical to collect breath samples from these patients in order to determine whether a unique organic compound profile can be identified in CF exacerbations.


Eligibility Criteria:
Inclusion Criteria:

1. Diagnosis of Cystic Fibrosis based on genetic testing and/or sweat chloride levels
2. F508Del homozygous or heterozygous (F508Del with another severe CFTR mutation)
3. Age over 18 years
4. Able to provide written informed consent
5. Current exacerbation requiring inpatient or outpatient treatment at Royal Papworth Hospital.
6. Chronic infection with Pseudomonas aeruginosa, as defined as \>50% of sputum culture or cough swabs being positive in the preceding 12 months
7. Baseline FEV1 30%-with no predicted upper limit

Exclusion Criteria:

1. Patients unable to provide written informed consent
2. Patients whose clinical status precludes use of the ReCIVA (mask) Breath Sampler due to oxygen dependency or tachypnoea
3. Patients who require admission to intensive care
4. Lung transplant recipients
First in Human Study of NI-0701 in Healthy Volunteers

The purpose of this study is to determine the safety, pharmacodynamic and pharmacokinetic profiles of a novel therapeutic drug when administered to healthy volunteers.


Eligibility Criteria:
Inclusion Criteria:

* Non smokers
* Able to adhere to study visits and protocol requirements

Exclusion Criteria:

* Any clinical safety laboratory measurements value \> Grade 1 on WHO Toxicity Scale
* Established or recurrent history of allergic reactions
Evaluating Muscle Weakness Improvement With Lorcaserin in ICU

ICU acquired muscle weakness is a significant problem in patients recovering from critical illness. This trial will evaluate the safety and efficacy of a drug in improving muscle weakness in critically ill patients.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 years old
* Sepsis \[ ≥2 Systemic Inflammatory Response Syndrome (SIRS) Criteria AND known or suspected infection\]
* Muscle weakness \[Medical Research Council sum score \<48/60 or handgrip strength \<11 kg in men and \<7 kg in women\]
* Obey Commands \[Score for DeJonghe Awakening Score of ≥3/5\]

Exclusion Criteria:

* Severe renal insufficiency \[Creatinine Clearance \<30 mL/min - or receiving dialysis\]
* Acute infectious or auto-immune hepatitis, acute liver failure or a history of cirrhosis without liver transplant
* History of psychosis
* Bradycardia, or 2nd or 3rd degree Atrio-Ventricular block without pacemaker
* History of valvular heart disease without valve replacement
* History of priapism
* Pre-existing cognitive impairment
* Receiving drugs with serotonergic effects and/or CYP2D6 substrates which cannot be substituted stopped or titrated.
* Receiving Sulfonylurea medication at the time of the study
* Prior neuromuscular or central nervous system disease, including pre-existing neuropathy
* Inability to perform study's muscle strength assessments based on patient's baseline status prior to hospital admission
* Unable to receive, or unlikely to absorb study drug (e.g. bowel obstruction, ischemia, or infarction; short gut syndrome)
* Body mass index \>40
* Patient not expected to survive \>4 days
* Pregnancy or lactation
* Allergy to lorcaserin or lorcaserin taken in the prior 7 days
* Enrolled in another interventional drug or physical rehabilitation trial
* Physician declines for patient to be enrolled
* Patient or proxy declines consent
* Unable to reach proxy for consent
* Non-English speaking
A Clinical Trial to Evaluate the Efficacy and Safety of HL301 Versus Placebo in Acute Bronchitis Patients

A Multicenter, Randomized, Double-blinded, Placebo-controlled, Parallel, Phase II Clinical Trial to Evaluate the Efficacy and Safety of HL301 versus Placebo in acute bronchitis patients.

Endpoint: BSS, The improvement and improvement rate of the tester for the treatment response, The satisfaction of the subject, Total usage of Acetaminophen


Eligibility Criteria:
Inclusion Criteria:

1. Both gender, 19 years ≤ age ≤ 80 years
2. (Bronchitis Severity Score)\* ≥ 5point at Visit 2 (Randomized Visit)
3. Acute bronchitis within 48hr based on Visit 2 (Randomized Visit)
4. Those who can comply with the requirements of clinical trials
5. Written consent voluntarily to participate in this clinical trial

Exclusion Criteria:

1. Patients with respiratory and systemic infections requiring systemic antibiotic therapy
2. Patients with bleeding tendency
3. Patients who investigators determines to severe respiratory disease that would interfere with study assessment
4. Patients who were treated with oral systemic adrenocortical hormone or immunosuppressive drug within 4 weeks prior to Visit 2
5. Patients who were treated with oral antihistamines, ACE suppressive. or systemic/inhalative glucocorticosteroid within 2 weeks prior to Visit 2
A Study of Lumasiran in Infants and Young Children With Primary Hyperoxaluria Type 1

The purpose of this study is to evaluate the efficacy, safety, pharmacokinetics (PK), and pharmacodynamics (PD) of lumasiran in infants and young children with confirmed primary hyperoxaluria type 1 (PH1).


Eligibility Criteria:
Inclusion Criteria:

* Has genetic confirmation of primary hyperoxaluria type 1 (PH1)
* Meets urinary oxalate excretion requirements
* If taking Vitamin B6 (pyridoxine), must have been on stable regimen for at least 90 days

Exclusion Criteria:

* If \<12 months old at screening, has an abnormally high serum creatinine
* If ≥12 months old at screening, has an estimated glomerular filtration rate (GFR) of ≤45 mL/min/1.73m\^2
* Clinical evidence of systemic oxalosis
* History of kidney or liver transplant