cyrilzakka/clinical-trials huggingface dataset:
Development and Evaluation of a Sleep-coaching Program

In the present study, a 4-week sleep coaching program is developed and evaluated in members of the German armed Forces. The aim of the program is to provide an efficient tool to prevent sleep disorders, and to improve mild sleep disorders, with a special focus on insomnia.

In the present study, a sleep-coaching program for small groups of a maximum of eight participants is developed. The program is comprised of four different sessions and is provided to member of the German armed forces. One session lasts approximately 1.5 hours and sessions are applied on a weekly basis. Each session deals with a different topic, addressing all major categories of sleep disorders (insomnia, hypersomnia, circadian rhythm disorders, sleep-related breathing disorders) and teaching ways of self-help and information on when to seek medical treatment. The program is evaluated by a cross-over study design with treatment and waiting control groups. After the treatment group has finished the course, the waiting group attends the sleep coaching session. All subjects fill in sleep logs and several questionnaires prior to (t0) and after the treatment group has finished the sleep coaching (t1), after the waiting group has finished the course (t2), and in a 3-month follow-up session (t3). Furthermore, sleep is recorded according to the AASM-standard criteria for two consecutive nights each at the time-points t0, t1, and t2. Subjective and objective sleep quality will be compared across the time-points, and between groups. In total, at least 48 participants are included in study.

Eligibility Criteria:
Inclusion Criteria:

* subjectively impaired sleep quality
* member of the German armed forces

Exclusion Criteria:

* subjects with a clinically relevant psychiatric decease
* not able to give informed consent
Indiana University Dementia Screening Trial

The purpose of the study is to conduct a randomized clinical trial assessing the harms and benefits of screening for dementia, compared to no screening for dementia, among 4,000 older adults, cared for in typical, primary care practices.

The objective of this proposal is to address the question of whether the benefits outweigh the harms of routine screening for dementia among older adults in primary care when the screening program is coupled with primary care practices prepared to provide care for those who screen positive.

The specific aim of the study is to conduct a pragmatic randomized clinical trial assessing the harms and benefits of screening for dementia, compared to no screening for dementia, among 4,000 typical, older adults, cared for in typical, primary care practices, prepared to deliver best practices dementia care.

Primary Specific Aim 1:

Test the impact of dementia screening on health-related quality of life of the patient at 12 months.

Primary Specific Aim 2:

Test the impact of dementia screening on the mood and anxiety symptoms of patient at 1 month (i.e., primary potential harms).

Secondary Aims: Estimate the cost effectiveness of dementia screening.

Eligibility Criteria:
Inclusion Criteria:

* adults age 65 and older;
* at least one office visit to their primary care physician within the previous year;
* no previous diagnosis of dementia or memory problem as determined by ICD-9 codes or the presence of prescription for anti-dementia medications (cholinesterase inhibitors or memantine);
* ability to consent to participate in the study; and
* ability to communicate in English

Exclusion Criteria:

* adults who are a permanent resident of a nursing facility;
* a serious mental illness such as bipolar disorder or schizophrenia as determined by the presence of related ICD-9 codes indicative of such an illness; or
* a pre-existing diagnosis of dementia or cognitive impairment
A Study to Learn About Effects of Living With COVID-19 and the Use of the Medicines Nirmatrelvir-Ritonavir in Treating COVID-19.

The purpose of this study is to learn about:

* effects of living with COVID-19 and
* how effective is nirmatrelvir-ritonavir in treating COVID-19.

This is a study of two groups of COVID-19 patients in Taiwan.

In Group 1 the below participants were included in the study:

* Patients of all ages.
* Patients who were confirmed to have COVID-19 infection between 01 January 2021 and 31 December 2021.
* Cases of patients registered in the databases.

In Group 2 the below participants were included in the study:

* Participants who are 12 years or older.
* Confirmed to have COVID-19 between 01 January 2022 and 31 December 2022.

Nirmatrelvir-ritonavir is taken by mouth and is used to treat COVID-19.

The study will look at:

* the nature of Covid-19 disease.
* as well as the experiences of people receiving the nirmatrelvir-ritonavir.

This study will help to:

* understand what type of patients will need to be admitted to hospitals.
* see severe results due to COVID 19 infection.
* have more knowledge on the use of nirmatrelvir/ritonavir on COVID-19.


Eligibility Criteria:
Cohort 1:

Inclusion Criteria:

* Patients of all ages
* Patients with a diagnosis of COVID-19 infection between 01 January 2021 and 31 December 2021
* Cases of patients registered in the databases

Exclusion Criteria:

* Patients without COVID-19 diagnosis

Cohort 2:

Inclusion Criteria:

* ≥12 years of age
* Have COVID-19 diagnosis with international classification of diseases (ICD) code between 01 January 2022 and 31 December 2022

Exclusion Criteria:

* Patients without COVID-19 diagnosis
Radiation Induced Cardiopulmonary Injury in Humans

The purpose of the study is to assess the time, dose dependence, and fraction-size dependence of radiation (RT)-induced changes in regional lung and heart perfusion/function/structure following thoracic RT delivered using newer IMRT/conformal/radiosurgery techniques. The PI hopes to develop models to better relate and predict RT-induced changes in regional lung and heart perfusion/function/structure with changes in global cardiopulmonary function. Patients will undergo pre- and serial post-RT lung and heart assessments to better understand RT-induced regional heart/lung changes.


Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 18 years
2. Patients who are to receive 3D-planned RT for tumor within and around the thorax.
3. Patients receiving incidental RT to portions of the heart are eligible.
4. Estimated minimum expected life expectancy of one year
5. Able to undergo the required study-related tests for regional lung injury and regional heart injury
6. Patients of child bearing potential age must have a negative pregnancy test and must agree to use appropriate birth control measures while in the study.
7. Patients must be able to give informed consent. Informed consent will be obtained prior to enrollment.

Exclusion Criteria:

1. Patients who are anticipated to have thoracic surgery post-RT are ineligible.
2. Patients with large mediastinal/hilar tumors compressing the airways/vessels, and negatively impacting on cardiovascular function
3. Pregnant or nursing women.
Epidural Analgesia and Delivery of Second Twin

Over an 8-year period, 124 twin pregnancies at gestational age ≥32 weeks with both twins presenting as a vertex and eligible for vaginal delivery were reviewed. Excluded were patients with the following intrapartum factors which may affect mode of delivery of second twin: 1. Presentation of the 2nd twin: breech or other than vertex; 2. Monochorionic twins; 3. Induction of labour; 4. difference in foetal weight between twin B and twin A ≥25%. The chi-square statistic was used to compare differences in the incidence of retained second twin between the groups.

The investigators conducted this prospective study in women with twins pregnancy planned for trial of vaginal delivery and gave birth between January 2014 and December 2019, in the Department of obstetrics and Gynaecology of the Sabah Maternity Hospital, Sabah Specialized Area, Kuwait. The Sabah Maternity Hospital is a tertiary care hospital for the country of Kuwait with approximately 12500 deliveries per year. The study protocol was approved by the Ethics Committee.

Eligibility Criteria:
Inclusion Criteria:

.gestational age of 32 weeks, determined by an early ultrasound performed in the second trimester or certain last menstrual period; (2) both twins viable; (3) eligibility for vaginal delivery as defined by twin A being cephalic; and (4) no previous cesarean section.

Exclusion Criteria:

* underwent an elective or repeat cesarean section
* presentation of twin B at delivery other than cephalic (breech, oblique or transverse presentation
* induction of labour
* the difference in foetal weight between twin B and twin A at delivery ≥25% .Neonates were excluded if one was stillborn or had major congenital malformations.
Effect of Vitamin C, D and Zinc Supplementation on the Immune and Inflammatory Process in Type 2 Diabetic Subjects

Type 2 Diabetes Mellitus According to the World Health Organization (WHO), there are more than 346 million individuals with diabetes, of which 90% are type 2. Global estimations for the year 2030 predict an epidemic increase that will reach 366 million. According to the National Nutrition and Health Survey of 2006 (ENSANUT2005), there are 6.4 million type 2 diabetic subjects in Mexico.

According to the calculation of the sample size, the investigators will include 120 adults with type 2 diabetes mellitus selected from the outpatient preventive medicine offices of health centres in the State of Mexico who will divided in two groups: supplement and placebo (60 per group). After having been invited to participate and obtaining the informed consent, study subjects will be evaluated for dietary information, as well as biochemical biomarkers of metabolic control, anthropometric, immune and inflammatory markers, gut microbiota and oxidative stress, before beginning the trial, and after 12 and 24 weeks of supplementation. They will have a monthly follow-up visit for evaluation of adherence and adverse effects, as well as delivery of the supplement.

Subjects will be randomly allocated to a supplementation with 1000 mg vitamin C, 400 IU vitamin D and 10 mg of zinc or placebo group, during 24 weeks. Subjects and researchers will be blinded to the supplement or placebo in order to guarantee double-blinding.

Eligibility Criteria:
Inclusion Criteria:

* Between 25 and 55 years of age, as this is the age in which type 2 diabetes mellitus is more prevalent and there is less probability of encountering multiple diseases in the same subjects
* Both sexes
* Outpatients
* BMI ≥ 25

Exclusion Criteria:

* Without any other chronic disease (cancer, cardiovascular diseases, arthritis and Alzheimer's).
* Severe renal insufficiency.
* Nephrolithiasis or history of nephrolithiasis.
* Hyperoxaluria.
* Hemochromatosis.
* Hypercalcaemia.
* Hypervitaminosis D.
* Using insulin.
* Be taking drugs such as desferrioxamine, iron, cyclosporine, indinavir (protease inhibitors), warfarin, thiazide diuretic, orlistat, ion exchange resins (e.g cholestyramine, laxatives (e.g. mineral oil, senna), vitamin d analogues (e.g. ergocalciferol, calcitriol, and topical calcipotriene), tetracycline antibiotics, quinolone antibiotics, penicillamine, biphosphonates, levothyroxine, eltrombopag.
* Patients with hypersensitivity to any of the active substance(s) or to any of the excipients.
* Hypersensitivity to the by-products including honey, conifers, poplars, Peru balsam, and salicylate.
* Intake of probiotics or supplemental vitamin or mineral (vitamin D, C, zinc or calcium) for 4 weeks before the beginning of the study.
* Smoking and alcohol consumption (\> 40 gr/ day for men and 25 gr/ day for women.
* Pregnant or lactating.
* Whose parents or grandparents are/were immigrant or of native origin.
Tarsal Tunnel Syndrome and Fibromyalgia

Widespread pain is observed in patients diagnosed with fibromyalgia, and lower extremity and foot pain are also common. In our study, we aimed to evaluate the relationship between foot pain and tarsal tunnel syndrome in female patients diagnosed with fibromyalgia.


Eligibility Criteria:
Inclusion Criteria:

* 18-65 age
* Diagnosed with fibromyalgia according to ACR criteria

Exclusion Criteria:

* Have any severe mental or psychological disorder
* Have significant hearing and/or vision loss
* Presence of foot deformity, previous fracture, arthritis, tendon pathology that may cause foot pain detected in the physical examination of the foot and ankle joint.
* Presence of systemic inflammatory disease
* Having any systemic disease that may cause polyneuropathy.
Magnesium Sulfate and Neuroendocrine Hormone

Total knee arthroplasty is a procedure that relieves pain in patients with severe symptomatic osteoarthritis, but it can be associated with postoperative pain, which hinders recovery. In the previous study, we reported evidence of increased pain in patients undergoing staged total knee arthroplasty, in whom the second operated knee had greater sensitivity (tertiary hyperalgesia) as a result of the surgical injury to the first operated knee.

Magnesium sulfate is an effective analgesic adjuvant for postoperative pain. Its analgesic property seems to be associated with the regulation of calcium influx into the cells, or antagonism of N-methyl-D-aspartate receptors in the central nervous system. Additionally, magnesium is known to have an anti-inflammatory effect. Inflammatory state may accompany with pain via peripheral or central sensitization.

Recently, we reported that magnesium sulfate effectively attenuates not only postoperative pain but also increased pain intensity without serious adverse effects in the bilateral staged total knee arthroplasty. However, the exact mechanism regarding these effects of magnesium sulfate remains unclear.

In the present study, we will investigate the analgesic mechanism of magnesium sulfate via analysis of endocrine neurosteroid levels in patients undergoing bilateral staged total knee arthroplasty.


Eligibility Criteria:
Inclusion Criteria:

* Patients who undergo staged bilateral total knee arthroplasty
* Spinal anesthesia
* American Society of Anesthesiologists physical status 1 and 2

Exclusion Criteria:

* Patients who undergo unilateral total knee arthroplasty
* General anesthesia
* Musculoskeletal disease
* Hypermagnesemia
* Atrioventricular block
* Previous history of administration of calcium channel blockers
Effect of Virtual Reality on Pain, Arterial Blood Gases and Functional Capacity in Children After Open Heart Surgery

This study will be conducted to investigate:

* The effect of virtual reality on pain in children after open heart surgery,
* The effect of virtual reality on arterial blood gases in children after open heart surgery,
* The effect of virtual reality on functional capacity in children after open heart surgery.


Eligibility Criteria:
Inclusion Criteria:

* Both genders will be included.
* Their age range from 6 to 12 years.
* Children after open heart surgery ( phase I cardiac rehabilitation).

Exclusion Criteria:

The children have one or more of the following will be excluded:

* Any child Suffering from any other chronic congenital diseases.
* Severe visual or auditory problems.
* Neurological problems.
* Vertigo problems.
* Post surgical hemorrhage.
* Post surgical arrhythmia.
Effect of Guided Imagery for Radiotherapy-Related Distress in Patients With Head and Neck Cancer

The goal of this interdisciplinary pilot study is to evaluate the feasibility, acceptability and preliminary efficacy of a guided imagery intervention to reduce radiotherapy-related symptoms of anxiety and depression in patients with head and neck cancers relative to treatment as usual.

The goal of this interdisciplinary pilot study is to evaluate the feasibility, acceptability and preliminary efficacy of a guided imagery intervention to reduce radiotherapy-related symptoms of anxiety and depression in patients with head and neck cancers relative to treatment as usual. Treatment as usual contains no psychological interventions to aid in distress, however participants will have access to the psychosocial supports at the cancer center available to all patients. Patients will be randomized to either condition, and surveys of their well-being will be conducted throughout the study.

Eligibility Criteria:
Inclusion Criteria:

1. Provision to sign and date the consent form.
2. Stated willingness to comply with all study procedures and be available for the duration of the study.
3. Be aged 18 - 100.
4. Ability to read and communicate in English.
5. A confirmed malignancy of the head and neck region (including metastases from other primary tumors and cancers of unknown primary.
6. Initiation of RT at the University of Colorado Cancer Center.
7. Psychiatric and cognitive stability as assessed by chart review (i.e., no documented dementia diagnosis or unmanaged psychiatric symptoms) and study personnel (i.e., ability to attend to meeting with study personnel).
8. Ability to meet remotely via internet connection or over the phone.

Exclusion Criteria:

1. Any individual who does not meet the inclusion criteria.
2. Those who are determined, by mental health professionals, to be psychiatrically unstable.
Safety and Effectiveness of Combining Hydroxyurea (HU) With Didanosine (ddI) and Stavudine (d4T) for Treatment of HIV-Infected Adults

The purpose of this study is to compare the safety and effectiveness of 9 doses of HU in order to find the best dose of HU to use with ddI and d4T in fighting HIV infection.

HU plus ddI plus d4T appears to be a suitable anti-HIV drug combination for long-term control of HIV. This combination can sharply decrease viral load (level of HIV in the body) with few side effects, making it easy to take.

The combination of HU plus ddI plus d4T appears to be suitable for long-term control of HIV in that it: (1) has a novel resistance/rebound profile demonstrating virus suppression even in the presence of ddI-resistant mutants; (2) can produce a pronounced fall in viral load; and (3) is well tolerated (over 200 patients have been treated for up to 3 years with minimal side effects).

Patients are stratified by antiretroviral experience: naive (no more than 2 weeks of therapy) versus experienced (more than 2 weeks). Patients must discontinue all antiretroviral therapy for at least 28 days prior to randomization to 1 of 9 HU treatment arms. Treatment arms are divided into 3 HU dose categories: very low, low, and medium. Within each category HU is administered daily on 3 different dosing schedules. Depending on viral load, patients on the very low and low dose arms may have the opportunity to intensify their HU dose at any time beyond Week 12, provided no Grade 3 or 4 HU-related toxicity is present (these patients are monitored for an additional 8 weeks following intensification). All patients receive ddI and d4T at the same doses every day. When 50% of patients have completed 24 weeks of treatment, an analysis is made to determine whether or not to continue the 52-week study without modifications. Patients are monitored periodically for changes in plasma HIV RNA, CD4 cell counts, weight, and symptoms.

Eligibility Criteria:
Inclusion Criteria

Patients may be eligible for this study if they:

* Are HIV-positive.
* Have a viral load of 5,000 to 100,000 copies/ml.
* Are willing to stop all anti-HIV medications for at least 28 days before receiving study drugs.
* Are at least 18 years old.

Exclusion Criteria

Patients will not be eligible for this study if they:

* Have a history of opportunistic (AIDS-related) infection.
* Have a history of pancreatitis or other serious condition.
* Have any cancer that will require chemotherapy within the next 24 weeks.
* Are allergic to ddI or d4T.
* Have received an HIV vaccine within 28 days of study entry.
* Have received a red blood cell transfusion within the past 60 days, or have had repeated transfusions at any time in the past.
* Abuse alcohol or drugs.
* Have received certain medications.
Efficacy of Smartphone Application Based Rehabilitations in Patients With Chronic Respiratory or Cardiovascular Disease

In Republic of Korea, it is not easy to practice standard pulmonary rehabilitation (PR) or cardiac rehabilitation (CR). In this study, the investigators will provide newly developed smartphone application to patients with chronic respiratory or cardiovascular diseases. The investigators want to confirm whether participants, who perform smartphone application based 12-week PR or CR program, present improved exercise capacity, dyspnea symptom, muscle strength, or quality of life.


Eligibility Criteria:
Inclusion Criteria:

* Dyspnea symptom \>= mMRC 1 or NYHA II
* adults between 20 years and 80 or years

  * Chronic respiratory disease
* FEV1/FVC \< 0.7 or FEV1\< 0.8 of predicted value in pulmonary function test
* bronchiectasis in more than one lobe on chest computed tomography
* FVC or DLCO \< 0.8 of predicted value in pulmonary function test

  * Chronic cardiovascular disease
* Reperfusion Therapy for angina pectoris or myocardial infarction
* Heart failure with reduced ejection fraction (LVEF \< 50%)

Exclusion Criteria:

* history of acute exacerbation within 4 weeks
* unable to comply rehabilitation program
* not suitable for study on decision by duty physician
* no consent