cyrilzakka/clinical-trials huggingface dataset:
Exercise for Young Adults With Cancer

Over the past decade, importance of supportive care in cancer treatment of young cancer patients has increased. However, most common cancer-related side effects, such as physical deconditioning, psychological problems, infertility, and cancer-related fatigue, are particularly problematic for young adults (AYA). Short- and long-term side effects result in impaired quality of life, social life, and physical activity levels. While there is growing evidence that physical exercise is effective in reducing disease- or treatment-related side effects, programs are generally not tailored to the unique needs of young adults. In addition, social media or web-based programs are rarely structurally integrated into existing care programs. The objective of the Your Exercise Program (YOUEX) study is therefore to address these specific needs and to improve physical exercise services for young people in Germany. To this end, this pilot study presents three approaches to physical activity enhancement, with a particular focus on web-based and cross-regional programs. All three approaches will be evaluated for their feasibility and effectiveness on fatigue, distress, quality of life, and activity levels, as well as sustained effects over 24 weeks. The YOUEX study is an exploratory intervention study in the form of a 12-week exercise program for patients aged 18 to 39 years who currently have or have had a cancer diagnosis within the past 5 years. Eligible patients can choose from three support programs: Social Media Exercise Program, Online Exercise Platform, Supervised Exercise Program. The goal is to recruit 70 to 80 patients over an 8-month period. Evaluation questionnaires will be sent at three time points (T0: start of exercise program, T1: after 6 weeks; T2: after 12 weeks; T3: after 24 weeks) with a short weekly questionnaire between T0 and T2 to assess weekly adherence and changes in fatigue. YOUEX study will collect detailed information on the acceptability and feasibility of different physical activity programs for young people and their lasting effects on fatigue, quality of life and physical activity. Should these be positive, the findings can directly inform health care practice, which would be highly relevant especially in light of the COVID pandemic.


Eligibility Criteria:
Inclusion Criteria:

* cancer diagnosis within the past five years
* signed informed consent

Exclusion Criteria:

* cancer-related cognitive impairment
* lack of sports clearance from the attending oncologist (e.g. in case of fragile bone metastases)
* current participation in another exercise intervention
* insufficient German language skills
China Research for Severe Spontaneous Intracerebral Hemorrhage（CRISIH）

Background: Despite the capability of emergency surgery to reduce the mortality of severe spontaneous intracranial hemorrhage (SSICH) patients, the effect and safety of surgical treatment for severe spontaneous intracranial hemorrhage (SSICH) patients receiving long-term oral antiplatelet treatment (LOAPT) remains unclear. In consideration of this, the cohort study is aimed at figuring out the effect and safety of emergency surgery for SSICH patients on LOAPT.

Methods: As a multicenter and prospective cohort study, it will be conducted across 7 representative clinical centers. Starting in September 2019, the observation is scheduled to be completed by December 2022, with a total of 450 SSICH patients recruited. The information on clinical, radiological, and laboratory practices will be recorded objectively. All of the patients will be monitored until death or 6 months after the occurrence of primary hemorrhage.

Study Design: In this study, two comparative cohorts and an observational cohort will be set up. The primary outcome is the effect of emergency surgery, which is subject to assessment using the total mortality and comparison in the survival rate of SSICH patients on LOAPT between surgical treatment and conservative treatment. The second outcome is the safety of surgery, with the postoperative hemorrhagic complication which is compared between the operated SSICH patients on and not on LOAPT. Based on the observation of the characteristics and outcome of SSICH patients on LOAPT, the ischemic events after discontinuing LOAPT will be further addressed, and the coagulation function assessment system for operated SSICH patients on LOAPT will be established.

Objective: In this study, investigators will estimate the effect and safety of emergency surgery for SSICH patients on LOAPT, which will provide an evidence for management in the future.


Eligibility Criteria:
Inclusion Criteria:

* (1) 18-75 years old;
* (2) non-traumatic intracerebral hemorrhage;
* (3) severe intracerebral hemorrhage, which was defined as patients with supratentorial bleeding volume \> 30 ml, infratentorial bleeding volume \> 10 ml, midline shift \> 1 cm, or large intraventricular hematoma;
* (4) Glasgow coma score (GCS) \< 13;
* (5) family members agree to provide an informed written consent.

Exclusion Criteria:

* (1) patients had cerebrovascular diseases, e.g., intracranial aneurysm or vascular malformation, and intracranial tumors, which were associated with hemorrhage;
* (2) hemorrhagic transformation of cerebral infarction;
* (3) hemorrhage caused by venous thrombosis;
* (4) patients with severe coagulation disorder, e.g., hemophilia;
* (5) patients with coagulation dysfunction caused by malignant tumor, hepatic insufficiency, renal dysfunction, thrombocytopenia, coagulation diseases, and so on;
* (6) patients receiving other anticoagulation medications (vitamin K antagonist and new oral anticoagulants);
* (7) patients not on LOAPT who receive conservative treatment;
* (8) the patients who died before or on arriving at the hospital and within a short period (6 h) after admission.
Part A: Drug Interaction Study of Sofosbuvir and Antiretroviral Therapy (ART) Combinations in HIV and Hepatitis C Virus (HCV) Co-infected Patients. Part B: Efficacy and Safety of Sofosbuvir for 12 Weeks in HIV/HCV Co-infected Patients.

This study consists of 2 parts, Part A and Part B. Part A, the Phase 1 drug interaction/early viral kinetic study, will evaluate the effect of selected antiretroviral therapies on the safety, viral kinetics, and pharmacokinetics of sofosbuvir (GS-7977; PSI-7977) and its metabolites in participants with HIV and hepatitis C virus (HCV) coinfection. Part B, the Phase 2 treatment study, will investigate the efficacy and safety of sofosbuvir, pegylated interferon alpha (PEG) and ribavirin (RBV) in participants with HIV/HCV coinfection.


Eligibility Criteria:
Inclusion Criteria:

* Healthy according to medical history and physical examination with exception of HCV and HIV diagnoses
* Confirmation of Chronic HCV infection
* Confirmation of Chronic HIV-1 infection
* On a stable protocol approved HIV antiretroviral (ARV) regimen with undetectable HIV-RNA
* Agree to use two forms of highly effective contraception for the duration of the study and 6 months after the last dose of study medication
* Subjects must be naive to treatment for chronic HCV infection

Exclusion Criteria:

* Known or suspected cirrhosis
* History of any other clinically significant chronic liver disease
* A history consistent with decompensated liver disease.
* Use of any prohibited medications as defined by the protocol
* Pregnant or nursing female or male with pregnant female partner
* Contraindication to PEG or RBV therapy (for Part B)
* Clinically relevant drug or alcohol abuse
Chinese Regional Spinal Muscular Atrophy Patient Registration Study

The primary objectives of this study are to obtain clinically meaningful data on the survival, outcomes, prognosis and treatment effect of all the patients with spinal muscular atrophy (SMA) 5q types 1 to 3 (according to international classification), being followed in the Children's Hospital, Zhejiang University School of Medicine since October 2019. The registry will collect retrospectively and prospectively the longitudinal data of the long-term follow-up for children patients, under real life conditions of current medical practice, in order to document the clinical evolution of patients (survival, motor, respiratory, orthopedic and nutritional and so on), the conditions of use of the treatments, the mortality rates of treated and untreated patients, the tolerance of the treatments, adverse events.

The detailed objectives of this study included but not be limited to the following aspects:

1. to collect and describe overall demographic, familial, clinical, biological, and genetic characteristics of patients with 5qSMA diagnosed and treated in regions of China, by the type of SMA (type 1,2, and 3);
2. to study the impact of proactive and symptomatic medical interventions (such as bracing) and medications (disease-modifying treatment, anti-infectious, digestive, nutritional supplements, ect.) in the evolution of patients;
3. to study the long-term evolution (survival, motor and respiratory functions, spinal shape, growth and nutritional function) of 5qSMA in treated and untreated populations, by new available therapies;
4. to study the incidence and mortality rate of 5qSMA in treated and untreated populations;
5. to identify and document the different therapeutic strategies by sub-populations and by discontinuation or follow-up of treatments;
6. to evaluate prognostic factors of responses to different drug therapies;
7. to study the tolerance of treatments by type of treatments, by type of SMA and overall tolerance (including adverse events);
8. to help popularize newborn screening for SMA and pre-symptom treatment among Chinese population;
9. to get knowledge of the probable costs of care for 5qSMA patients in different groups (disease types, ages);
10. to provide needful elements to evaluate the health care costs for the disease;
11. to study the autonomy and the quality of life of patients depending on different therapies and the impact on patients' caregivers;
12. to help facilitate development of basic research on SMA in the conduct of trials on new treatment.

Eligibility Criteria:
Inclusion Criteria:

1. Genetically confirmed 5qSMA patients through 1 to 3 types younger than 18 years old followed in our hospital since October 2019;
2. For prospective study: inform consent form signed by patient;
3. Not combined with any other genetic and metabolic diseases;

Exclusion Criteria:

1. Other type of SMA (not 5q).
2. Under guardianship or curatorship.
3. Unable to understand or cooperate with the study.
Comparing the Effects of Insulin Glargine on Blood Glucose Between Needle-free Jet Injection and Insulin Pen

To comparing the blood sugar improvement and patient sensibility of insulin glargine injected with needle-free jet injector and conventional insulin pen

Compared with conventional pen, needle-free jet injection of insulin has faster flow rate and larger area of local subcutaneous absorption. The aim of this study was to investigate the effects of subcutaneous insulin glargine injection with needle-free jet injection and conventional pen on blood glucose profile and safety in type 2 diabetic patients.

Eligibility Criteria:
Inclusion Criteria:

* volunteer to participate and be able to sign informed consent prior to the trial.
* patients with type 2 diabetes, aged 18-80 years old, meeting WHO1999 diagnostic criteria, have not used any hypoglycemic drugs. The dosage of insulin glargine (4-35 units) combined with oral medicationis, stable for more than 2 months.
* No acute complications such as diabetic ketoacidosis, diabetic hyperosmolar syndrome, etc.
* Subjects are able and willing to monitor peripheral blood sugar and regularity of diet and exercise.

Exclusion Criteria:

* Patients with insulin allergy.
* Impaired liver and kidney function with ALT 2.5 times higher than the upper limit of normal value;Serum creatinine was 1.3 times higher than the upper limit of normal.
* Drug abuse and alcohol dependence in the past 5 years.
* Systemic hormone therapy was used in the last three months.
* Patients with poor compliance and irregular diet and exercise.
* Patients with pregnancy, lactation or pregnancy intention.
* Any other obvious conditions or associated diseases determined by the researcher: such as severe cardiopulmonary diseases, endocrine diseases, neurological diseases, tumors and other diseases, other pancreatic diseases, history of mental diseases.
Comparison of The Effects of Concentric And Eccentric Isokinetic Exercises in Patients With Knee Osteoarthritis

This study aims to compare the effects of concentric and eccentric isokinetic exercises on proprioception and muscle architecture in 42 patients with knee osteoarthritis enrolled the study.

This study aims to compare the effects of concentric and eccentric isokinetic exercises on proprioception and muscle architecture in patients with knee osteoarthritis. 42 patients will be included in this study. Patients will be divided into three groups; concentric exercise group (n:14), eccentric exercise group (n:14) and control group (n:14). A conventional physiotherapy program and a standard therapeutic exercise program will be applied to all subjects. In addition to these exercise and physiotherapy programme, concentric and eccentric exercise groups will perform the exercises related to their groups. All three groups will participate in this program for a total of 18 sessions 3 times a week for 6 weeks. All groups will be subject to re-evaluation after 6 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of primary knee osteoarthritis according to American College of Radiology
* Being radiographically K-L grade 2-3
* Presence of symptoms for at least 3 months
* Patients who have been planned a conventional physiotherapy programme because of knee osteoarthritis
* Presence of functional capacity for outpatient physical therapy

Exclusion Criteria:

* Patients with seconder knee osteoarthritis
* History of lower extremity or spine surgery
* History of intraarticular injection in last 1 month
* Patients with neurological disease that will affect muscle strength, balance and coordination
Determination of Protein Requirements in Elderly Female Subjects >75 Yrs Old

Minimal data are available on protein requirements throughout the lifespan. Currently available recommendations are based on nitrogen balance data. The limitations of the nitrogen balance method have been well described. Importantly, nitrogen balanced underestimates requirements.

The current DRI requirement for healthy adult males is based on the reanalysis of the nitrogen balance date from Young and Scrimshaw. This data was reanalyzed statistically by Rand et al. and he concluded that the protein requirement of healthy adults was 0.65 and 0.83 (mean and RDA) g/kg/day of good quality protein. Using IAAO, the investigators group estimated the protein requirement of young men (mean age 27 years) to be 0.93 and 1.2 g/kg/day (mean and RDA).

Currently there are no studies on protein requirement in the elderly. In a recent nutrition survey conducted by NHANES, the authors concluded that adults between the ages of 51 - 70 years old consumed an average on 1.0 g/kg/day (ideal body weight) of protein which represents about 15 % of calories. Depending on the calculations used for ideal body weight some older adults could be getting higher or lower than requirement. There is no scientifically derived protein estimate for older adults. Therefore there is a need to measurer protein requirement in that population.

The goal of this study therefore is to measure the protein requirement of female elderly subjects \>75 years using the IAAO technique.


Eligibility Criteria:
Inclusion Criteria:

1. Healthy elderly females \>75 years
2. Willingness to participate in the study
3. Females without a chronic disease or acute illness that could affect protein and AA metabolism eg, diabetes, cancer, liver or kidney disease, HIV, acute cold or flu, hypo or hyperthyroidism, rheumatoid arthritis treated with anti-inflammatory medications.
4. Females with hypertension if well controlled by medications -

Exclusion Criteria:

1. Presence of disease known to affect protein and AA requirement and synthesis like diabetes, cancer, liver o kidney disease, HIV, acute cold or flu, hypo or hyperthyroidism, rheumatoid arthritis treated with anti-inflammatory medications.
2. On medications known to affect protein and amino acid metabolism like e.g. steroids.
3. Significant weight loss during the past month.
4. Individual on weight reducing diets.
5. Inability to tolerate the diet or unwilling to have blood drawn from a venous access for the purposes of the study.
6. Significant coffee consumption of more than 2 cups/day (400 mg of caffeine/day)
7. Significant Alcohol consumption of more than one drink/day ( 1 beer, ½ glass of wine) -
Improving Resilience and Longevity for Workers Through Exercise

The purpose of this study is to examine the impact of an OA-specific aerobic and strengthening exercise program, delivered within the workplace, on mobility, pain, physical capacity, and resilience among workers with knee or hip OA as well as those with no joint pain. The investigators hypothesize that exercise designed for OA, delivered at work, will improve all of these outcomes.

The Canadian workforce is aging. The most prevalent age group is 50-54 years and most of these Canadians will aim to continue working over the next 10 years. However, the impact of arthritis on aging Canadians compromises their ability to continue working. By 2031, over 2 million Canadians aged 45 to 64 years will have arthritis. The investigators aim to boost the ability of adults with the most common arthritis, osteoarthritis (OA), as well as adults without OA, to engage in the workforce for as long as they desire. Identifying strategies to promote productivity among workers with knee and hip OA will be of great public health significance in the coming decades. However, the investigators face two challenges. First, obesity among sedentary workers is a risk for worsening knee and hip OA. Second, large occupational loads on the knee and hip worsen OA. Exercise has the most promise in addressing these challenges because it reduces pain and sick time, and improves mental health. Thus, there is a call for studies examining exercise for workers with knee and hip OA.

Eligibility Criteria:
Inclusion Criteria:

* full-time or part-time administrative employees

Exclusion Criteria:

* Any other forms of arthritis
* Osteoporosis-related fracture
* History of patellofemoral symptoms
* Active non-arthritic hip or knee disease
* Hip or knee surgery
* Use of cane or walking aid
* Unstable heart condition
* Neurological conditions
* Hip, knee or ankle injuries in past 3 months
* Physician-advised restriction to physical activity
* Any injuries that would prohibit participation in exercise
* Ipsilateral ankle conditions
* Currently receiving cancer treatment
* Currently pregnant
Comparing EVCO and EVOO

The aim of this study is to compare acute effects of consuming extra virgin coconut oil (EVCO) as a source of medium chain fatty acids and extra virgin olive oil (EVOO) as a source of long chain fatty acids in normal weight and obese subjects.

Twenty male subjects (10 normal weight; 10 obese) consumed breakfast meals containing skimmed milk, fat-free white cheese, bread and EVCO (25 g) or EVOO (25 g). Visual analog scale evaluations, resting metabolic rate measurements and selected blood parameters analysis (glucose, triglyceride, insulin and plasma peptide YY) were performed before and after the test breakfast meals. In addition, energy intakes were evaluated by ad libitum lunch meal at 180 min.

Eligibility Criteria:
Inclusion Criteria:

* Metabolically healthy
* Aged 19-40 years
* Normal weight (BMI=18.5-24.9 kg/m²) and obese men (BMI=30-34.99 kg/m²)

Exclusion Criteria:

* smoking,
* alcohol consumption,
* weight gain/loss recently (\> %5, in three months),
* any genetic and metabolic diseases,
* any food allergy/intolerance,
* any medication,
* restrained eating habits.
Effectiveness of Nurse-delivered Care for Adherence/Mood in HIV in South Africa

The purpose of this study is to conduct a two-arm effectiveness trial in Cape Town, South Africa of a Xhosa-adapted, nurse-delivered, cognitive behavioral therapy (CBT) treatment for depression and adherence, integrated into the HIV care setting in patients with HIV who did not achieve viral suppression from first-line treatment. The CBT treatment will be compared to enhanced usual care (Enhanced Treatment As Usual - ETAU) on study endpoints (as described in study endpoints section below).

Clinical Clinical depression is one of the highest comorbidities to HIV/AIDS, with estimated rates up to 34.9 percent. Depression, in the context of HIV, leads to poor self-care behavior such as non-adherence to ART and worse retention in care, which are critical for treatment success. Based on our prior work, and given that CBT is an evidenced-based treatment for depression, this is a two-arm effectiveness randomized controlled trial of nurse-delivered cognitive behavioral therapy for depression and adherence integrated into the HIV primary care setting in S. Africa. To ensure that those who need this intervention the most will receive it, participants will be patients with HIV who did not achieve viral suppression from their first line ART, and have a unipolar depressive mood disorder.

Eligibility Criteria:
Inclusion Criteria:

* HIV-seropositive
* Current diagnosis of depression
* Did not attain viral suppression from first-line ARV per local clinic standard

Exclusion Criteria:

* Unable or unwilling to provide informed consent.
* Active untreated, major mental illness (untreated psychosis or mania) that would interfere with CBT-AD.
* Has not received CBT for depression.
* Less than 18 years of age.
Caries Prevention Potential of Pearl Powder Versus CPP-ACP on Enamel White Spot Lesions

to evaluate the caries prevention potential of pearl powder against CPP-ACP in enamel white spot lesions.

The aim of the study is to evaluate the caries prevention potential of pearl powder against CPP-ACP in enamel White Spot Lesions using laser fluorescence device scoring from 0 to 99, with daily application time of 3 months and follow up period of 6,9,and 12 months.

Eligibility Criteria:
Inclusion Criteria:

* good oral hygiene
* cooperative patient
* completion of orthodontic therapy
* presence of at least two white spot lesions on the labial surface of six maxillary anterior teeth, that were not present before orthodontic treatment

Exclusion Criteria:

* bad oral hygiene
* lack of patients compliance
* allergy to milk products
* pregnant or lactating women
* presence of dentin caries, restorations, or enamel hypoplasia on maxillary anterior teeth
* presence of periodontal pockets around maxillary anterior teeth