cyrilzakka/clinical-trials huggingface dataset:
Lifestyle Intervention for OSA in Adults

Obstructive sleep apnoea (OSA) is characterized by the presence in the polysomnogram test of more than five apnoea-hypopnoea episodes per hour of sleep (apnoea-hypopnoea index, AHI \> 5), each episode lasting more than 10 seconds and being accompanied by oxygen desaturation or arousal. The prevalence of this syndrome is worryingly high (9% to 38%), affecting more men than women. OSA has an important negative impact on physical/psychological health and on these patient's quality of life. The gold-standard treatment for OSA is the continuous positive airway pressure (CPAP). However, CPAP compliance is really low, this device requiring a continuous chronic use in order to improve OSA and to avoid the relapse. Furthermore, it does not address OSA risk factors such as obesity and unhealthy lifestyle habits. Consequently, non-surgical and non-pharmacological interventions such as weight loss and lifestyle interventions are necessary and recommended by the American Academy of Sleep Medicine (AASM). The objective of this project, therefore, is the development and evaluation of a cognitive-behavioural treatment program for patients with moderate-severe OSA. The treatment will pursued weight loss through hypocaloric diet and moderate exercise, smoking and alcohol avoidance, and sleep hygiene. The efficacy of this treatment will be assessed in comparison with CPAP, in a short and medium term. This intervention could be considered a good alternative/combined management to the usual treatment of OSA (CPAP) once its efficacy to reduce and even cure OSA symptoms is demonstrated, especially if it is still effective in the long-term.


Eligibility Criteria:
Inclusion Criteria:

* Previous clinical diagnosis of moderate/severe OSA (AHI \> 15) by a healthcare professional.
* Male patients aged between 18-65 years.
* Body mass index \> 25 kg/m2.
* Use of CPAP
* Motivation to participate in the study.
* Signed informed consent form.

Exclusion Criteria:

* Sleep disorder other than OSA
* Clinically significant psychiatric, neurological, or medical disorders other than OSA
* Use of prescription drugs or clinically significant drugs affecting sleep
Metabolic Phenotyping During Stress Hyperglycemia in Cardiac Surgery Patients

This study is a prospective randomized study to examine the effects of exposure to dulaglutide on the prevention of stress-hyperglycemia and the metabolic inflammatory response in the perioperative period.

Stress hyperglycemia is common in the perioperative period and is associated with increased risk of death postoperatively. Counterregulatory hormones and inflammatory mediators appear to modulate the acute biological response to stress, however, the pathophysiological pathways that result in stress hyperglycemia and its link to poor clinical outcomes are not well understood. At least half of non-diabetes mellitus (DM) patients undergoing cardiac surgery develop stress hyperglycemia shown to be an independent risk factor of morbidity and mortality. The current approach to treat hyperglycemia with insulin has major limitations including high resource utilization and high risk of hypoglycemia. The main goals of this study are to examine baseline and postoperative metabolic profiles of non-diabetic, coronary artery bypass grafting (CABG) patients with stress hyperglycemia and to study the effect of a long-acting glucagon-like peptide-1 receptor agonists (GLP-1 RA) on the prevention of stress-hyperglycemia and modulation of metabolic stress during cardiac surgery.

To examine whether exposure to dulaglutide, a GLP-1 RA, can improve glycemic control and ameliorate the inflammatory response to acute surgical stress, obese patients without diabetes mellitus undergoing CABG surgery will be randomized to receive either dulaglutide or placebo two to three days prior to surgery. The researchers of this study ultimately want to provide evidence to support the use of novel therapies to prevent and manage stress hyperglycemia in the inpatient setting.

Eligibility Criteria:
Inclusion Criteria:

* Males or females between the ages of 40 and 80 years
* Body mass index (BMI) ≥25
* Undergoing elective CABG surgery
* No previous history of diabetes or hyperglycemia

Exclusion Criteria:

* Hyperglycemia (BG\>125 mg/dl or HbA1c \> 6.5%) or previous treatment with antidiabetic agents
* Impaired renal function (GFR \< 30 ml/min) or clinically significant hepatic failure
* Gastrointestinal obstruction expected to require gastrointestinal suction
* Patients with clinically relevant pancreatic or gallbladder disease
* Treatment with oral or injectable corticosteroid
* Mental condition rendering the subject unable to understand the possible consequences of the study
* Pregnancy or breastfeeding at time of enrollment
Preimplantation Genetic Screening in IVF Treatment

This is the pilot phase of a randomised controlled trial.

The purpose of the pilot study is to assess the ability to recruit, randomise, adherence to the study protocol and plan for a full study.

The purpose of the full study will be to determine if a policy of embryo selection and transfer based on morphological evaluation and preimplantation genetic testing for aneuploidy (PGT-A) is a more clinically effective, safer, cost-effective and acceptable way to provide in vitro fertilisation (IVF) treatment in women of advanced reproductive age compared to the routine practice of embryo selection and transfer based on morphological evaluation alone.

The target population for the trial are women aged 35 - 42 years undergoing IVF±ICSI treatment.

Intervention The experimental strategy will be to perform PGT-A (also referred as preimplantation genetic screening - PGS) involving trophectoderm biopsy on embryos reaching the blastocyst stage on day 5/6/7 following egg collection. All embryos will be frozen after the biopsy procedure.

Comprehensive chromosome screening (CCS) of all chromosomes will be performed using next generation sequencing (NGS). Embryos will be categorised as euploid, mosaic euploid and aneuploid embryos and embryos will be ranked based on the degree of euploidy.

Only euploid embryos or mosaic euploid embryos deemed suitable to be replaced will be transferred in subsequent frozen-thawed embryo transfer cycles.

Comparison Women in the control arm will have the fresh embryo transfer procedure on day 5 following egg collection or a frozen-thawed embryo transfer as first line if clinically indicated in keeping with current routine practice. Embryo selection for transfer will be based on morphological criteria alone.

Eligibility Criteria:
Inclusion Criteria:

* Inclusion criteria for the study would be women aged 35 - 42 years undergoing IVF ± ICSI for treatment of infertility
* Patients with 3 or more good quality embryos (assessed according to the embryo scoring system of the Association of Clinical Embryologists, UK) on day 3 following egg collection
* Ability to provide informed written consent

Exclusion Criteria:

* Women undergoing preimplantation genetic testing for inherited genetic disorders
* Gamete donation cycles
* Untreated hydrosalpinges
* Untreated uterine pathology (eg: endometrial polyps, submucous fibroids, intramural fibroids \> 5 centimetres in maximum diameter, intrauterine adhesions, uterine septa)
Safety, Efficacy and Pharmacokinetics Study of ALD518 in Patients With Active Rheumatoid Arthritis

The purpose of this study is to determine the safety and efficacy of ALD518 in three different doses in patients who have not had an adequate response to methotrexate.

This will be a phase II, parallel-group, double-blind, randomized, placebo-controlled study of ALD518 in patients with active RA with an inadequate response to methotrexate.

Enrolled patients will be screened within a 4-week period (Day -35 to -7). within a 12-day period (Day-14 to -3) before initial dosing on Day 1 patients will be randomized to one of the following four treatment groups:

Group A: 2x ALD518 80 mg Group B: 2x ALD518 160 mg Group C: 2x ALD518 320 mg Group D: 2x placebo

In all treatment groups patients will continue to take a stable dose of methotrexate.

There will be a total of 11 visits. The total duration of the patient study participation will be approximately 16 weeks (excluding the screening period).

Eligibility Criteria:
Inclusion Criteria:

* Active Rheumatoid Arthritis for at least 16 weeks duration
* Have a C-reactive protein (CRP) of ≥ 10mg/L
* Have a stable dose of methotrexate (≥ 10mg/week) for at least 3 months

Exclusion Criteria:

* Arthritis onset prior to 16 years old
* Received any biologic therapy in the previous 12 months
* A history of or currently have active tuberculosis
* Any clinically significant concurrent medical condition
Dental Implants Placed by Using a Drill Guide Versus Non-guided Placement. Follow-up Study

To assess implant outcomes, both clinical and radiological, in a randomized study on guided implant placement after 3-year follow-up, compared to non-guided treatment.


Eligibility Criteria:
Inclusion Criteria:

1. Provision of informed consent
2. An age of at least 18 year
3. Extraction socket healing for at least 6 months

Exclusion Criteria:

1. Unlikely to be able to comply with study procedures
2. History of intravenous bisphosphonate treatment
3. Medical history that makes implant insertion unfavorable
4. Current pregnancy
5. Present alcohol and/or drug abuse
6. Major systemic diseases
7. Untreated, uncontrolled caries and/or periodontal disease
8. History of local irradiation
9. Need for bone grafting and/or sinus lift in the planned implant area
Effects of Photobiomodulation on Insomnia in the Elderly: Clinical Trials of Phototherapy Devices

The study will recruit 60 participants aged 60 and above, who suffered from insomnia for at least 3 months. Sleep parameters and chronotypes assessed with questionnaires and actigraphy, daytime sleepiness, and biological rhythm (dim light melatonin onset) will be measured. The intervention involves light exposure using a prototype device developed by GCSOL Tech Co., Ltd., a company with expertise in light therapy research and development. Three conditions will be tested (1) bright light; (2) near-infrared light; (3) bright light+ near-infrared light. Data analysis will employ paired t-tests to compare sleep parameters and dim light melatonin onset before and after treatment. Kruskal-Wallis tests and multivariate linear regression will be used to examine differences between intervention groups, controlling for gender and age. Safety analysis will include monitoring adverse events.


Eligibility Criteria:
Inclusion Criteria:

* Pittsburgh Sleep Quality Index score is 8 or above.
* Early wakening ( 30 minutes before expected), or interruptted sleep for more than 30 minutes, lasting for more than 3 months.

Exclusion Criteria:

* Movement disorder, inability to move independently.
* Skin diseases, skin cancer, photosensitive skin diseases, or taking drugs that may cause photosensitivity (lithium salts, melatonin, antibiotics, A acid).
* Eye diseases such as glaucoma, diabetic retinopathy, and cataracts.
* Bipolar disorder.
* Light-induced epilepsy.
* Sleep disorders such as sleep apnea and involuntary leg twitching.
* Currently taking sedative-hypnotic drugs or receiving other non-drug treatments.
* Beck depression inventory-II score is greater than 13 points.
* Those who use cardiac rhythm regulators or artificial cardiopulmonary pacemakers.
* Acute illness.
* Abnormal blood pressure or fever.
* Pregnancy and pregnant women.
* Special physical abnormalities and sensory nerve abnormalities.
* Infectious diseases.
* Coagulation disorder.
Measurement of Gait Spatio-Temporal Characteristics in Knee Osteoarthritis Patients

The purpose of the study is to evaluate the gait spatio-temporal parameters of patients with degenerative changes in the knee joint and to relate them with 2 questionares (WOMAC and SF-36).


Eligibility Criteria:
Inclusion Criteria:

* Symptomatic knee OA for at least 6 months
* Fulfilled American College of Rheumatology clinical criteria for OA of the knee
* Radiographically assessed OA of the knee graded 1-4 according to the Kellgren \& Lawrence scale

Exclusion Criteria:

* Acute septic arthritis
* Patients with an increased tendency to fall
* Lack of physical or mental ability to perform or comply with the treatment procedure
* Diabetes mellitus
* History of pathological osteoporotic fracture
The Impact Of Physician Communication On Family Inpatient Experience

Patient satisfaction is affected by physician communication styles and communication at the bedside. The investigators are conducting a randomized controlled trial involving both providers and families to determine if providers sitting down while talking with families, will improve one aspect of quality care delivered during an inpatient stay as measured by patient/family satisfaction. The investigators will additionally study the affects of the intervention on the following outcomes: family assessment of provider communication, readmission rates, and length of stay.


Eligibility Criteria:
Inclusion Criteria:

* Providers: all attendings, residents, and medical students involved in the care of patients on the pediatric inpatient wards during the study period.
* Families (Parents or legal guardians and children):
* (1) inpatient admissions to the pediatrics medical service at Boston Medical Center
* (2) whose parents or guardian have agreed to participate in family centered walk rounds
* (3) patients age 17 or younger who have family members present at the bedside each morning of hospitalization
* (4) English speaking.

Exclusion Criteria:

* (1) All patients/families that as part of admission justification involves social assessment and concern by the patient care team, including patients with neonatal abstinence syndrome, child maltreatment, and concern for neglect.
* (2) All patients transferred to or from PICU as part of their inpatient care
* (3) All patients transferred from an outside institution to the inpatient ward for further care secondary to progression of disease.
Multi-chip Meta-analysis of Parkinson's Disease for Clinical Validation of Small Samples of Key Genes in Disease

The research team used meta-analytical statistical methods to integrate the results of different research groups on Parkinson's disease, using meta-analysis to find key genes related to the pathogenesis and development of Parkinson's disease, and to make small clinical results. The verification of the sample, the internal mechanism of the pathogenesis of Parkinson's disease and provide guidance and reference for subsequent experimental research.

Parkinson's disease (PD) is a relatively common degenerative disease of the central nervous system. As society gradually becomes aging, the number of PD patients is increasing, but its exact pathogenesis is still not fully understood. May be related to genetic factors, environmental factors, immunological abnormalities, mitochondrial dysfunction and oxidative stress, ageing, apoptosis and other factors; the current genetic diagnosis is in the ascendant, making the understanding of the etiology and pathogenesis of Parkinson's disease more In-depth, provide more basis and means for the pathogenesis and development of Parkinson's disease, but due to the number of individual samples, operational norms and platform differences, different research groups have great differences in the results of gene chip research on Parkinson's mechanism, resulting in the reliability is poor; In order to improve the credibility of the pathogenesis of Parkinson's disease and the development of genetic diagnosis, the investigators use the statistical means of meta-analysis to integrate the results of the chip research on Parkinson's disease in different research groups and find synaptic correlation function may be closely related to the development of Parkinson's disease, PPP2CA, PPP3CB, SYNJ1, NSF, CYCS genes may be key genes in the pathogenesis of Parkinson's disease, and the expression of these genes is related to the pathogenesis and development of PD patients. the investigators will conduct a small sample validation in the clinic to explore the intrinsic mechanism of Parkinson's disease and follow-up experimental research provides guidance and reference.

Eligibility Criteria:
Inclusion Criteria:

* PD group：

  * Patients who meet the 2016 China Parkinson's diagnostic criteria and the 2015 International Parkinson's and Movement Disorders Association (MDS) Parkinson's disease diagnostic criteria
  * Newly diagnosed primary PD patients, diagnosed within 3-6 months
  * Informed consent to the study
  * Age \> 18 older
* Non-PD group:

  * Age, gender-matched PD group
  * Non-PD, non-PDS, non-neurological degenerative disease, patients without inflammatory disease and related family history
  * Informed consent to the study
  * Age \> 18 older

Exclusion Criteria:

* Severe craniocerebral trauma patients
* Disturbance of consciousness
* Severe organic diseases, cerebral hemorrhage, cerebral thrombosis, severe coronary heart disease and lung disease, severe liver and kidney dysfunction, severe diabetes, severe hearing And visual impairment
* History of severe brain tumors, encephalitis or brain surgery
Ketamine in Chronic Kid's (KiCK) Pain

This study is designed to select the most tolerable dose of oral ketamine for children with chronic pain. Children will be given either placebo or one of three dosages of oral ketamine for 2 weeks. The dosage that is most tolerable will be selected for further study.

Children with chronic pain are randomized to one of four arms (three study drug arms, one placebo arm) in a randomized, double-blinded fashion. Children are treated for 2 weeks and then monitored for an additional 12 weeks. Study participation is a total of 14 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Subject, parent, or guardian willing and able to give informed consent
* NRS for pain over the past 24 hours \>4 at baseline
* Chronic pain, which has been present for \>3 months, or persisting longer than is normal for the underlying diagnosis
* Chronic pain related to physiologic diagnoses including but not limited to: cancer, rheumatologic disease, sickle cell anemia, cystic fibrosis, pancreatitis, and neuromuscular disease (e.g. Duchenne muscular dystrophy)
* Able to tolerate and cooperate with neurocognitive assessment
* Age 8-20 years old

Exclusion Criteria:

* If they are known or suspected to have drug addiction
* Uncontrolled psychiatric disorder such as depression, schizophrenia, or bipolar disorder
* Uncontrolled hypertension
* Known liver disease or elevation of AST or ALT greater than 3 times the upper limit of normal.
* Previous intolerance or allergic reaction to ketamine
* Pregnancy
* Use of CYP3A4 inhibitors or inducers within the 2-week period prior the study drug administration or within 5 half-lives of the respective medication, whichever is longer, until study conclusion.
* Consumption of grapefruit or grapefruit products from at least 2 weeks prior to study drug administration until study conclusion.
The Effectiveness and Safety of SBRT in the Treatment of Patients With MPLC After Surgery (SMILE)

To prospectively evaluate the effectiveness and safety of SBRT in the treatment of residual malignant pulmonary nodules after lung cancer, and is committed to providing new treatment options for patients with multiple primary malignant pulmonary nodules who cannot tolerate multiple operations.


Eligibility Criteria:
Inclusion Criteria:

(1) Age 18-75 years old; (2) ECOG score 0-2 points; (3) Chest CT showed at least two lung nodules (pure ground glass, partial solid or solid nodules); (4) At least one lesion has been pathologically diagnosed as lung cancer (T1N0M0-T1N1M0); (5) At least one residual pulmonary nodule has been diagnosed pathologically or multidisciplinary diagnosis and treatment (MDT) discussed and considered as a primary malignant pulmonary nodule; (6) The residual lung nodules are inoperable or operable but the patient refuses to be surgically removed; (7) Have self-consciousness and can sign informed consent; (8) Must be able to swallow tablets.

Exclusion Criteria:

(1) There are metastatic pulmonary nodules; (2) Have received chest radiotherapy in the past; (3) Lymph node metastasis or distant metastasis; (4) The tumor is located in the proximal bronchial tree area. The proximal bronchial tree is defined as carina, left and right main bronchus, left and right upper lobe bronchus, middle bronchus, right middle lobe bronchus, lingual bronchus, left and right lower lobe bronchi; the proximal bronchial tree area is defined as surrounding the proximal bronchial tree in all directions The area within 2cm above; (5) Pneumonectomy patients; (6) Severe primary diseases such as heart, liver, kidney, hematopoietic system, etc.; (7) Women during pregnancy and lactation; (8) Active period of the human immunodeficiency virus (HIV) infection; (9) Those with active systemic infection, pneumonia, tuberculosis, and pericarditis; (10) There is a history of psychotropic drug abuse or drug abuse;(11)Insulin dependent diabetes;(12) Thyroid disease
Your Health in On Click

A health education program was provided to higher education students aged between 18 and 25 years. Students were recruited either by posters and leaflets on campus, or during their mandatory medical survey at the University Medical Department. The objectives are to assess health behavior risk among college student : e.g eating disorders, binge drinking, electronic cigarettes and also stress, burnout


Eligibility Criteria:
Inclusion Criteria:

* Aged 18-25 years
* College students

Exclusion Criteria:

* No college students
Community-embedded Reproductive Health Care for Adolescents in Latin America.

Adolescents in Latin America are at major risk for unwanted pregnancies leading to unsafe abortions and maternal health risks. Mostly, adolescent health programmes tend to focus on unidirectional interventions aiming at a single determinant of adolescents´ sexual and reproductive health. However, evidence exists that a complex health problem should be addressed by an equally nuanced and multipronged response. Knowledge is lacking on how to develop a comprehensive approach to promote adolescents' sexual health.

The CERCA study will conduct an implementation based on the hypothesis that a comprehensive strategy of community-embedded interventions helps to improve the sexual health of adolescents. We will test this hypothesis and describe the development, implementation and testing of interventions in three Latin American cities: Cochabamba (Bolivia), Cuenca (Ecuador) and Managua (Nicaragua).

The research methodology has been designed based on the methodological frameworks of action research, community based participatory research and intervention mapping.

The interventions are complex addressing different target groups (adolescents, parents, authorities and health providers) and focussing on various behaviours that are related to communication about sexuality, information seeking, access to health care and safe sexual intercourse.

For the evaluation of effectiveness a randomised and non-randomised controlled study was developed for respectively Managua and the two other cities. Furthermore a process evaluation is conducted.

This research will result in a framework that will contribute to the planning of interventions that are effective and responsive to adolescents' sexual health needs.


Eligibility Criteria:
Inclusion Criteria:

Nicaragua - adolescents aged 13-18 living in the 33 town districts of Managua with a population number that varies between 1400 and 4500 inhabitants and with more than 50 % poor people.

Bolivia and Ecuador: Students from conveniently selected secondary schools in Cochabamba (Bolivia) and Cuenca (Ecuador).