cyrilzakka/clinical-trials huggingface dataset:
Once Daily Long-Acting Muscarinic Antagonists Administered in the Evening for Prevention of Chronic Obstructive Pulmonary Disease Exacerbations Requiring Hospitalization or Death from Any Cause

To examine, among once-daily LAMA using COPD patients, whether evening administration of LAMA is superior with respect to the incidence of hospitalization requiring AECOPD or death from all causes than the more conventional morning administration.

One of the most feared complications associated with chronic obstructive pulmonary disease (COPD) is acute exacerbation (AECOPD). On average, each COPD patient experiences 0.5 to 3.5 acute exacerbations per year, which is an important reason for the hospitalization, disease progression and mortality as well as decline in health status and lung function(1,2).

Treatment with a long-acting muscarinic antagonist (LAMA) reduces dyspnoea and the risk of exacerbations in patients with COPD by binding to muscarinic receptors in bronchial smooth musculature and thus inhibiting cholinergic bronchial constriction. LAMAs are given as inhalation therapy once daily (most often) or twice daily(3).

Most COPD-patients experience their worst symptoms and experience exacerbations in early morning hours, before getting out of bed(4). This might be explained by the physiological diurnal changes in the activity of the parasympathetic homeostasis system since this is most active at night to improve digestion and other secretions(5).

Correspondingly, the activity of the sympathetic system is physiologically suppressed at night, and stimulation of β-2 receptors is thus also low (and opposite for M-3 receptors). Taken together, the balance of sympathetic-parasympathetic tone is shifted significantly towards the latter. Most available LAMA treatments are dosed once daily in the morning.

Thus, for a COPD patient, being at a trough level of LAMA (which antagonizes the para-sympathetic system) at late night/early morning, may carry a hazard for the patient.

Studies have found that lung function measured as forced expiratory volume in 1 second (FEV1) improvement peaks approximately 2 hours after LAMA administration, and that FEV1 is still significantly improved at 7 hours post treatment but decreases towards the trough level of the LAMA(6). However, as a corollary to the above, when the medicine is probably most needed (02.00 a.m. to 07.00 a.m.), the effect is at its lowest level, which may not be desirable, since a low effect of the most important preventive medicine against AECOPD at this time, may lead to more exacerbations.

Evening administration, on the contrary, would lead to a greater and more certain effect regarding bronchodilation and reduced secretion in the early morning hours, and a maximum effect should be expected during the entire night.

Eligibility Criteria:
Inclusion Criteria:

1. Age more than or equal to 30 years
2. Current treatment with LAMA once daily (as recorded in the Danish National Prescription Registry and confirmed by the participant via questionnaire)
3. Self-reported COPD

Exclusion Criteria:

1. Patients who decline to participate.
Assessing The Effectiveness of a Preoperative High Intensity Interval Training Programme In Older Colorectal Cancer Patients

The primary aim of this study is to determine whether an improvement in aerobic fitness, as judged by an increase in VO2peak, can be achieved within 31 days via HIT programme in a group of older, colorectal cancer patients.

12 high intensity interval training exercise sessions on a static cycle ergometer, over a period of 31 days. Each session lasts 18 minutes.

At the beginning and end of the study the following measures will be used to assess change in fitness, body composition and muscle metabolism. DXA scan, USS of thigh, VO2 peak cycling test, short performance battery tests, quality of life questionnaires and muscle biopsy.

Eligibility Criteria:
Inclusion Criteria:

* Confirmed colorectal cancer
* Offered curative treatment by the Royal Derby Hospital NHS Foundation Trust Colorectal Cancer Multidisciplinary Team
* Male and female
* 18-88 years of age

Exclusion Criteria:

* Uncontrolled hypertension (BP \> 160/100),
* Angina,
* Heart failure (class III/IV),
* Cardiac arrthymias,
* Right to left cardiac shunt,
* Recent cardiac event,
* Previous stroke/TIA,
* Aneurysm (large vessel or intracranial),
* Severe respiratory disease including pulmonary hypertension,
* COPD/asthma with an FEV1 less than 1.5 l,
* Coagulation disorders,
* Scarring disorders.
* Current neoadjuvant chemo/radiotherapy
* Inability to complete the consent process Involvement in invasive research study in previous 3 months.
Azoospermia Patients

The Prospective Cohort Study for Azoospermia Patients was set up to investigate the short- and long-term health consequences in Reproductive Medical Center, First Affiliated Hospital of Zhengzhou University, China.

Infertility is an important problem with a multifactorial etiology that affects approximately 15% of couples who attempt pregnancy. Its cause in approximately 50% of infertile couples is male factors. Spermatogenesis is an extremely complex cell differentiation process involving 2,300 genes that regulate germ cell development and maturation.

Since last decade, Clinical Reproductive Medicine Management System/Electronic Medical Record Cohort Database (CCRM/EMRCD) has been used in Reproductive Medical Center, First Affiliated Hospital of Zhengzhou University, and Henan Province Key Laboratory for Reproduction and Genetics. Information of patients (POI, PCOS, Endometriosis, azoospermia, ect) were recorded comprehensively. The current project plans to recruit azoospermia participants in our center. Biological samples, questionnaires and short/long term health data will be collected. The study is aimed to provide evidence for azoospermia prognosis.

Eligibility Criteria:
Inclusion Criteria:

* at least three semen evaluations performed on separate occasions, when the seminal specimen after centrifugation showed no sperm under the microscope and was then diagnosed according to several clinical parameters；

Exclusion Criteria:

-
Epidiolex in Obsessive Compulsive Disorder and Related Disorders

The primary objective of the proposed study is to evaluate the safety and efficacy of Epidiolex (cannabidiol) in adults with obsessive compulsive and related disorders (OCRDs). Subjects will be treated in an open-label fashion with Epidiolex for two weeks.

The primary objective of the proposed study is to evaluate the safety and efficacy of Epidiolex (cannabidiol) in adults with obsessive compulsive and related disorders (OCRDs). OCRDs include obsessive compulsive disorder (OCD), trichotillomania, skin picking, tourettes disorder, and hoarding disorders. These disorders appear linked in terms of phenomenology and possibly biology. Fifteen subjects with OCRDs will be treated in an open-label fashion with Epidiolex (2.5 mg/kg twice daily for one week followed by 5mg/kg twice daily) for two total weeks of active treatment. The hypothesis to be tested is that Epidiolex will result in reduction in symptoms of OCRDs (improvement in symptoms will be indicated by lower scores on established outcome measures of OCRDs symptoms that have been used in prior studies).

Eligibility Criteria:
Inclusion Criteria:

* Men and women age 18-65
* Primary diagnosis of OCD, Hoarding Disorder, Skin Picking Disorder, Trichotillomania, or Tourette Syndrome
* YBOCS score of at least 18 at baseline
* Ability to understand and sign the consent form.

Exclusion Criteria:

* Unstable medical illness based on history or clinically significant abnormalities on baseline physical examination or labs
* Current pregnancy or lactation, or inadequate contraception in women of childbearing potential
* Subjects considered an immediate suicide risk based on the Columbia Suicide Severity Rating Scale (C-SSRS)
* Past 12-month DSM-5 psychiatric disorder other than OCD
* Illegal substance use based on urine toxicology screening
* Initiation of psychological interventions within 3 months of screening
* Use of any other psychotropic medication
* Previous treatment with Epidiolex
* Cognitive impairment that interferes with the capacity to understand and self-administer medication or provide written informed consent
Tubal Factor in Unexplained Infertility

Ray and colleagues define "unexplained infertility" as failure to achieve pregnancy when the semen analysis is normal, evidence for ovulation is present, and tubal patency has been established. The efficacy of treatment declines with increasing age and duration of infertility Infertility is a disease , defined by the failure to achieve a successful pregnancy after 12 months or more of appropriate, timed unprotected intercourse or therapeutic donor insemination, barber evaluation and treatment may be justified based on medical history and physical findings and is warranted after 6 months for women over age 35 years.

In unexplained infertility abnormalities are likely to be present but not detected by current methods including semen analysis in the man, assessment of the state of ovulation, ovulation reserve and patency of uterine tubes in the woman.

unexplained infertility is not a rare item of infertility. Approximately 15% of infertility couple will be diagnosed with unexplained infertility after their diagnostic workup Many researches studied the laparoscopic tubal factor like tubo-ovarian relation, tubal kinks and fimbrial pathology. But we need to scope on more tubal factors like fatty mesosalpinx , fimbria ovarica, methylene blue free spill and others


Eligibility Criteria:
Inclusion Criteria:

* women with unexplained infertility.
* women in reproductive period between 20 and 35 years.
* primary or secondary infertility

Exclusion Criteria:

* with age less than 20 years and more than 35 years old
* other causes of infertility other than tubal factor
* Other contraindications for laparoscopy
Liraglutide and Cardio-Metabolic Risk Markers

Incretin-based therapies have shown significant effects beyond those on glucose metabolism. We aim in the present study to evaluate the effects of liraglutide on several cardio-metabolic risk markers.

In details, we will evaluate the effects of liraglutide on carotid-intima media thickness, oxidative stress, ghrelin, heat shock proteins and lipoproteins.

Eligibility Criteria:
Inclusion Criteria:

- patients with a diagnosis of type-2 diabetes

Exclusion Criteria:

- severe hepatic or renal diseases
Peginterferon Alfa-2a Plus Ribavirin Plus Amantadine for the Treatment of Hepatitis C Infected Patients

Response to a second-line anti-HCV treatment in non responder patients to a first-line dual therapy remains very poor. Preliminary studies of amantadine suggest that this drug could be potentially effective to treat hepatitis C.

Background : Response to a second-line anti-HCV treatment in non responder patients to a first-line dual therapy remains very poor. Preliminary studies of amantadine suggest that this drug could be potentially effective to treat hepatitis C.

Design : randomized, double-blind, multicenter trial.

Interventions compared : Peg-interferon alfa 2A + ribavirin + amantadine versus Peg-interferon alfa 2A + ribavirin + Placebo

Eligibility criteria : Chronic hepatitis C, previously treated with combination of interferon plus ribavirin for at least 24 weeks,detectable HCV RNA.

primary outcome : sustained virological response, defined as an undetectable HCV RNA level 24 weeks after the end of anti HCV treatment.

Eligibility Criteria:
Inclusion Criteria:

* Chronic hepatitis C
* Previously treated with a combination of interferon plus ribavirin for at least 24 weeks
* Detectable HCV RNA (i.e. non responders)
* Signed informed consent

Exclusion Criteria:

* Evidence of another cause of liver disease
* Liver cirrhosis (child-Pugh stage BMC)
* Alcohol consumption \> 30g/day for women or \> 40g/day for men ; drug abuse
* Other serious relevant disorders : psychiatric condition (especially depression), cardio-vascular disease, renal decompensation, seizure history, hemoglobinopathy, auto-immune disease
Become of Patients From the Permanent Access to Care (PASS) in Cayenne, French Guyana, Suffering From a Chronic Disease (High Blood Pressure - Diabetes) in the Common Law Schemes

It is an observational research, conducted at the Cayenne hospital about the future of hypertensive and/or diabetic patients after their follow-up at the Permanent Access to care (PASS). The PASS is a medico-social structure that allows access to medical monitoring and support towards common law. The main objective of the study is to evaluate the use of the common law system by these patients. Then the goal is to study the relationship between integration into the system and socio-demographic, medical characteristics, and understanding of health monitoring. Data will be collected by guided telephone interviews and the review of medical records.

The problems of social inequalities in access to care are major public health issues as recalled by the Regional Health Agency (ARS) of French Guiana in the Regional Health Project (PRS). French Guiana has high precariousness indicators with half of its population living below the poverty line. In addition, health indicators are often more degraded in precarious populations. Thus, in French Guiana, there is a higher rate of premature mortality, partly attributable to obesity, sedentary lifestyle, diabetes and hypertension than in mainland France. Despite an increased need for follow-up of chronic pathologies, the precarious population faces many difficulties in accessing care. The Permanent Access to Health Care (PASS) in Cayenne is a medico-social system, created to respond to these problems. The PASS allows access to monitoring of chronic diseases and support towards the common law healthcare system. Although the phenomenon of non-use of care studied in the precarious population of western French Guiana seems primarily attributable to the absence of social security. The main objective is to evaluate the use of the common law system in hypertensive or diabetic patients treated at the PASS in Cayenne. In addition, the investigators want to study the relationship between integration into the system and the socio-demographic, medical characteristics, understanding of health monitoring.

Eligibility Criteria:
Inclusion Criteria:

* Be 18 years or older
* Past follow-up by the PASS of the Cayenne hospital for at least one chronic pathology identified as follows: hypertension, diabetes.
* The discharge and reorientation to general practitioner have happened between 1 month and 1 year prior to this study.

Exclusion Criteria:

* Patient with a psychiatric condition
* Refusing the study
A Study of MORAb-202 in Participants With Previously Treated Metastatic Non-Small Cell Lung Cancer (NSCLC) Adenocarcinoma (AC)

The aim of this study is to characterize the safety and tolerability of MORAb-202, and to assess the objective response rate in participants with previously treated, metastatic NSCLC AC.


Eligibility Criteria:
Inclusion Criteria:

* Histologically or cytologically documented metastatic NSCLC AC (as defined by the 8th International Association for the Study of Lung Cancer Classification).
* Measurable target disease assessed by the investigator according to RECIST 1.1.
* Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1

Exclusion Criteria:

* NSCLC histologies other than AC (ie, squamous cell carcinoma, large cell carcinoma).
* Significant third-space fluid retention (eg, ascites or pleural effusion) that requires repeated drainage.
* Prior pneumonectomy. Prior lobectomy and segmentectomy are allowed \> 12 months before treatment.
* Recent chest radiotherapy. Participants with chest or chest wall radiation may be permitted if chest radiation is documented \> 6 months before starting study treatment.

Other protocol-defined inclusion/exclusion criteria apply.
An Alternative Radiation Fractionation Strategy for Locally Advanced Non-Small Cell Lung Cancer (NSCLC)

This phase I trial studies the best dose of radiation therapy in treating patients with locally advanced non-small cell lung cancer that cannot be removed by surgery. Radiation therapy uses high energy x rays to kill tumor cells. Specialized radiation therapy, such as stereotactic body radiation therapy (SBRT), that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. SBRT has been shown to provide excellent results when used in early stage lung cancer, but has not yet been applied to patients with more advanced disease.

PRIMARY OBJECTIVE:

To test the safety and tolerability of an alternative fractionation regimen in locally advanced non-small cell lung cancer (NSCLC), consisting of 44 Gy with concurrent chemotherapy followed by a stereotactic body radiation therapy (SBRT) boost to remaining parenchymal and nodal disease. The maximum tolerated dose of the SBRT boost will be determined.

SECONDARY OBJECTIVES:

1. To assess local control.
2. To assess distant metastasis and patterns of failure.
3. To assess overall survival at 1 and 2 years.

OUTLINE: This is a dose-escalation study of radiation therapy and SBRT.

Patients undergo radiation therapy daily and receive carboplatin and paclitaxel weekly for 4.5 weeks. Patients then undergo 2 boost SBRT treatments 2-3 days apart.

After completion of study treatment, patients are followed up for 5 years.

Eligibility Criteria:
Inclusion Criteria:

* Biopsy proven NSCLC, within 8 weeks prior to patient registration
* Unresectable disease
* Clinical stage Tx, T1-T4, N1-3, M0
* Karnofsky performance status (KPS) ≥ 70
* Pretreatment positron emission tomography (PET) CT scan to rule out metastatic disease

  * The primary tumor may not be larger than 8 cm in maximum dimension
  * If the primary tumor is central in location, defined as within 2 cm from the tracheobronchial tree, it must be no larger than 5 cm
  * Mediastinal and hilar lymphadenopathy can be no larger than 5 cm at any nodal station
* Pretreatment brain CT with contrast or brain MRI to rule out metastases
* Pathologic assessment of the mediastinum to document involved nodal stations
* All of the above inclusion criteria must occur within 8 weeks prior to patient registration, with the exception of pathologic assessment of the mediastinum and biopsy to confirm NSCLC, which can be done within 12 weeks of patient registration

Exclusion Criteria:

* Prior history of lung cancer
* Pregnancy
* Prior history of radiation to the chest
Evaluation of Endoplasmic Reticulum Stress in Patients With Recurrent Pregnancy Loss

To evaluate endoplasmic reticulum stress in women with recurrent pregnancy loss and those who had healthy births in the same age group. The level of the unfolded protein X box binding protein 1 (XBP-1) is measured. It is aimed to show the effect of endoplasmic reticulum stress on recurrent pregnancy loss.


Eligibility Criteria:
Inclusion Criteria:

* with three or more miscarriages before 20 th week of gestation
* had no chronic or acute inflammatory disease
* used no steroids, anti-inflammatory, or antioxidant medications

Exclusion Criteria:

* had inflammatory diseases
* had systemic disease
* Anatomical abnormalities, infectious, endocrine, or genetic etiologies
Effect of Treatment of Temporomandibular Joint in Patients With Chronic Migraine and Temporomandibular Disorders

The aim of this study is to determine whether treatment of temporomandibular joint is more effective than usual care in patients with chronic migraine and temporomandibular disorders to reduce pain.

The aim of this study is to determine whether treatment of temporomandibular joint added to the control group treatment and drug therapy patient base is more effective than just using the control group treatment and drug therapy in patients with chronic migraine and temporomandibular disorders to reduce pain and improve the quality of life related to health of patients.

Eligibility Criteria:
Inclusion Criteria:

* Chronic migraine (ICHD_III beta, 2013)
* Temporomandibular disorders (RDC/TMD)

Exclusion Criteria:

* other neurological disease
* psychiatric diseases
* Physical therapy treatment in the last 6 months
* dental treatment in the last 6 months
* surgery or trauma in the orofacial region
Optimizing Protein Patterns for Skeletal Muscle Preservation and Sleep in the Medical Management of Parkinson Disease

The purpose of this pilot study is to generate preliminary data on the impact of the dietary protein pattern on markers of skeletal muscle health and drug efficacy in Parkinson disease.

Parkinson's disease (PD) is a complex neurological disease that affects \~6.1 million people worldwide - mostly older adults \>60 years. The most effective treatment for PD is dopaminergic therapy, particularly levodopa (Ldopa). People with PD have variable responses to Ldopa, including degrees of motor fluctuations (MF) throughout the day. The half-life of Ldopa is \~1.5 h and therefore, dosage and timing are essential to mitigate MF. Ldopa is a large neutral amino acid (LNAA), and the bioavailability of Ldopa is compromised when simultaneously ingested with LNAA (e.g., leucine). Both Ldopa and LNAAs from food are absorbed through the same intestinal transporter, but LNAAs from food are preferentially absorbed by the enterocyte, limiting the bioavailability of Ldopa. Thus, the scientific community often recommends the protein-redistribution diet (PRD). With PRD, patients limit protein (\<10 g) at the desired time of medication efficacy (daytime) and meet their protein needs during the evening meal (\~70+g). There are deleterious implications of the PRD for older adults with PD; consumption of \>30 g of protein, in a single meal, will not sufficiently increase muscle protein synthesis. Additionally, the impact of the PRD on skeletal muscle quality and function has not been determined, and it is unclear, based on prior studies, whether the PRD enhanced drug absorption. Therefore, the objective of this study is to address these gaps in knowledge. This study will quantify the effects of dietary protein pattern on skeletal muscle in PD; determine the effects of dietary protein pattern on sleep quality in PD. This study is an acute, 5-week, crossover intervention with PD participants randomly assigned to first adhere to either the PCD or PRD. Participants will receive diet prescriptions and meal plans for their respective diet, and outcome measures will be assessed at days 0, 14, 21, and 35.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of idiopathic PD for 5 or more years
* 45 years or older
* On a stable levodopa regimen for 3 or more months
* Self-reported to experience motor fluctuations

Exclusion Criteria:

* Following a specific diet that would preclude participation
* Renal disease
* Deep brain stimulation
* Known narcolepsy
* Untreated sleep apnea
* Any condition that, in the opinion of the investigator, will preclude the participant from successfully or safely completing study procedures