cyrilzakka/clinical-trials huggingface dataset:
Resistance Training on Elderly Resilience

Background: There is on one hand sufficient evidence showing strong association between resilience and self-rated successful aging. On the other hand, strength training could contribute the cultivation of resilience among older adults. Therefore, the current study aims to examine the effectiveness of resistance training on resilience among Chinese older adults in Hong Kong.

Methods: This study will apply a three-group, double blinded (outcome assessors and data analysts), randomized controlled trial (RCT) to examine the effectiveness of the interventions on resilience, functional fitness, and health related quality of life immediately after a 16-week intervention, as well as the residual effects 12 weeks after completion of the interventions.

Discussion: It is expected that resistance training is promising or even superior to aerobic training in the improvement of resilience. Given the limited evidence on the literature, it is urgently needed to explore the effects of resistance training on the improvement of resilience in older adults. Findings of the current study can contribute to the development of effective resistant training programs for the promotion of resilience among older adults.


Eligibility Criteria:
Inclusion Criteria:

* 65 to 74 years old;
* capable to walk without assistive device;
* apparently healthy and live independently in communities

Exclusion Criteria:

* with cardiovascular or related diseases that prevent from resistance training;
* fail the PAR-Q screening or without physician's advice on readiness of participation in resistance training;
* with substantial experience in practicing resistance training or Tai Chi;
* with high level of resilience.
Growth in Children With HLHS

Children with HLHS have a history of poor enteral intake and growth. Over the past several years a modification to the Norwood operation was instituted (RV to PA shunt in place of the standard Blalock-Taussig shunt).

The purpose of this study is to evaluate whether children who underwent this modification of the Norwood procedure had improved growth compared to those in past years who underwent traditional Norwood.

The purpose of this study is to evaluate whether children who underwent this modification of the Norwood procedure had improved growth compared to those in past years who underwent traditional Norwood. Also, the standard of care has changed to GT/Nissen operation to facilitate "safe" feeding in those patients who are not able to feed by mouth (po feed).

A second aim of this study is to evaluate whether children who are GT fed have improved growth compared to those who are not.

We wish to review all patients who underwent Norwood procedure from January 1, 2001 to March 31, 2005.

Eligibility Criteria:
Inclusion Criteria:

* Patient at Children's Healthcare of Atlanta, Egleston Norwood procedure between Jan. 1. 2001 and March 31.2005

Exclusion Criteria:

* Those who do not meet inclusion criteria
The Efficacy of Exercise Therapy in Patients With Inflammatory Bowel Disease

this study aims to determine the effect of 8 weeks of exercise on the quality of life and muscle strength of patients with IBD. Patients will be randomized into 1) Intervention group: doing aerobic and resistance exercise according to physiotherapist prescription and 2) Control group: usual medical care. Both groups will continue their medications prescribed by the Gastroenterologist. After 8 weeks patients come back to the hospital for reevaluation of measured indices. The primary outcome of this study is the patient quality of life assessed by the IBDQ questionnaire. Other outcomes that will be evaluated before and after 8 weeks are muscle strength measured by a dynamometer and laboratory markers such as ESR and CRP and tool calprotectin. Also, disease activity using partial mayo score and Harvey Bradshaw score will be calculated and compared before and after treatment.

Inflammatory bowel disease has a huge burden both on patients and on the health system due to its chronic nature. Studies have shown a higher prevalence of sarcopenia, a condition in which muscle mass and strength decreases, in patients with IBD compared to age and sex-matched healthy individuals. Patients with IBD are physically less active than the normal population according to a couple of researches. There has been a growing interest to evaluate the effect of exercise on the quality of life and disease severity of IBD patients in recent years.

This study aims to determine the effectiveness of combined aerobic and resistance exercise on quality of life, physical function, muscle strength, disease activity, and laboratory markers in patients with established IBD.

The researchers will invite 56 patients to the Imam Khomeini hospital complex, Tehran, Iran. All patients will be enrolled after taking informed consent. Interventions will be conducted with the coordination of the patient's physician. Patients will be randomized to the intervention or control group. Outcome measurements will be evaluated immediately before and after the interventions (8 weeks period)

Eligibility Criteria:
Inclusion Criteria:

1. Patients with IBD (UC or Chron's) confirmed by colonoscopy and pathology
2. Be able to read and write in Farsi
3. Be able to participate to exercise therapy program.

Exclusion Criteria:

1. Patients with PSC
2. Patients with cirrhosis
3. Patients with colon cancer
4. Patients on corticosteroid treatment
5. Patients' dissatisfaction to continue the study for any reason
6. Patients who exercise on a daily routine (more than 30 minutes per day)
7. Patients having any contraindication for exercise training.
Prospective Study About Sensitization Pattern to Insects as Food Source in Patients With House Dust Mite Allergy

Patients allergic to seafood and/or sensitized to Tropomyosin of Skin Prick tests SPT or crustacean origin will may be also be sensitized to edible insects. Aim of the study is to evaluate whether patients allergic to seafood and/or sensitized to Tropomyosin of SPT or crustacean origin may be more often be sensitized to edible insects used as food source.

House dust mite allergy is a common problem in Europe. In addition to inhalant allergies sensitization to mites can be related to food allergy namely seafood. Insects are also widespread food sources in many regions of the world.

In this study skin testing and laboratory tests are planned in patients with known house dust mite allergy to evaluate a possible sensitization to insects. Patients must also complete a questionnaire. A drug therapy or other intervention is not planned.

Aim of the study is to evaluate whether patients allergic to seafood and/or sensitized to Tropomyosin of SPT or crustacean origin may be more often be sensitized to edible insects used as food source.

Eligibility Criteria:
Inclusion Criteria:

* Age: 18 \< x \< 70
* House dust mite sensitization with or without sensitization to seafood
* Subject is capable of giving informed consent
* Signed informed consent

Exclusion Criteria:

* Use of antihistamines, systemic corticosteroids during testing and within three days (antihistamines) or two weeks (corticosteroids) prior to testing
* Use of immunosuppressive agents
* History of cancer except for treated basal cell or spinal cell carcinoma of the skin
* Active or recurrent bacterial, fungal or viral infection at the time of enrollment, including patients with evidence of Human Immunodeficiency Virus (HIV) infection, Hepatitis B and Hepatitis C infection, active or untreated latent tuberculosis.
* Female patients of childbearing potential who are pregnant or breast feeding or planning a pregnancy during the duration of the trial and/or not practicing acceptable birth control for the duration of the trial
* Known or suspected non-compliance, drug or alcohol abuse,
* Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant,
* Previous enrollment into the current study,
* Enrollment of the investigator, his/her family members, employees and other dependent persons,
Comparison of King Vision Video Laryngoscope to McGrath MAC Video Laryngoscope for Nasal Intubation

This study was designed to determine the comparison between the King Vision video laryngoscope and McGrath MAC video laryngoscope for nasotracheal intubation.Patients were divided into 2 groups of 40 patients each.Patients of King Vision group \[n=40\]and Macintosh group \[n=40\]were intubated using respective devices.This study is the first to search the use of King Vision video laryngoscope for nasotracheal intubation in difficult airway.


Eligibility Criteria:
Inclusion Criteria:

* ASA physical status 1-2
* Scheduled for general anesthesia with nasotracheal intubation
* Cormach-Lehane score 3-4

Exclusion Criteria:

* contraindications to nasal intubation
* Patients with a history of anti-hypertensive drugs
Nordic Study in Newly Diagnosed Primary Central Nervous System (CNS) Lymphoma

The purpose of the study is to test the efficacy and tolerability of a multiagent chemotherapy treatment regimen without radiotherapy in patients with newly diagnosed lymphoma in the brain.

The objective of the study is

1. To investigate the efficacy and safety of a high-dose methotrexate-based induction polychemotherapy regimen combined with Rituximab and intraspinal DepoCyte followed by temozolomide maintenance treatment in newly diagnosed primary central nervous system lymphoma
2. To assess the long term outcome concerning neurotoxicity

Eligibility Criteria:
Inclusion Criteria:

* Pathologically verified primary central nervous system lymphoma No prior PCNSL treatment.
* Patients treated with steroids alone are eligible
* No signs of lymphoma outside the CNS
* ECOG performance status 0-4
* Age \> 17 and \< 76 years
* Written informed consent from the patient or guardian

Exclusion Criteria:

* Cardiac failure \> 3
* Pregnancy or lactation. Women of childbearing potential are requested to use an effective method of contraception to avoid pregnancy for a period from entry to the study and at least 3 months after the last study medication
* Previous malignancy unless disease free for at least five years
* Active infection.
* Regarding tuberculosis, patients at risk should be tested for latent TB according local practice at each treating centre.
* Positive HIV status
* Organ transplantation
* Serious psychiatric illness
* Prior radiotherapy to the brain
* Concomitant anti-inflammatory medication that cannot be discontinued
* Creatinine clearance \< 60 ml/minute calculated by Cockcroft and Gault formula
* Peripheral blood count with granulocytes \<1.5 x 109L or platelets \< 100 x 109L
* Serum bilirubin \>1.5 times or ASAT and alkaline phosphatase \>2 times upper limits of normal.
* Known anaphylaxis or IgE-mediated hypersensitivity to murine protein or any component of Rituximab excludes patients from Rituximab treatment, but not from the remaining part of the study
A Study of AG-80308 in Dry Eye Patients

This is a multicenter, double-masked, randomized, parallel-group study with topical AG-80308 eye drops in dry eye patients.


Eligibility Criteria:
Inclusion Criteria:

1. Male or female, 18 years of age or older at the screening visit
2. Diagnosis of dry eye disease in both eyes with or without meibomian gland disease

Exclusion Criteria:

1. Participation in any investigational study within 30 days prior to baseline or exposure to an investigational drug must be fully washed out (at least 5 half-lives)
2. Any ocular infection or inflammation within 30 days prior to the screening visit
3. Corneal disorder or abnormalities other than dry eye disease that impact normal spreading of the tear film (except superficial punctate keratitis)
4. History of chronic ocular allergy, systemic lupus erythematosus, rheumatoid arthritis, corneal ulcer/erosions, uveitis or dry eye due to Stevens Johnson syndrome, irradiation, alkali burns, cicatricial pemphigoid or vitamin A deficiency.
5. Use of contact lenses in either eye within 14 days of screening visit or planned use during the study
6. Use of the dry eye and/or meibomian gland disease medications/procedures within 2 to 8 weeks prior to the screening visit
The Influence of Glucose Flux on Fat Synthesis in a Whole Body Calorimeter

The study is carried out to find out the inclusion of high and low glycaemic index foods to daily meals and how they impact 24 hour blood glucose fluctuations and energy regulation.

The GI is a method of classifying foods based on the food's ability to raise the blood glucose level. Low GI foods are recommended as they have a lower impact on blood glucose concentrations. The research sets out to determine the effect of GI on 24 hour blood glucose profiles and energy regulation in Asians. Healthy, normal-weight, Chinese males will be recruited. There will be two sessions (consisting of four days for each session) where they will consume either a high or low GI breakfast, lunch, snack (in the whole body calorimeter), and a high or low glycaemic index dinner at home. They will take part in two test sessions (each spanning over 3 days) with at least five days in between the two sessions. Their glycaemic response will be measured using a Continuous Glucose Monitoring System (CGMS) throughout the period, while substrate oxidation will be measured over 10 hours in the calorimeter (from breakfast, lunch and snack). This study specifically attempts to see how having high and low GI meals impact on blood glucose levels and energy regulation in Asians. The study is important in that it will be the first of its kind in the whole body calorimeter and enable us to compute the rate of fat synthesis and how it is modulated when subjects are fed a high GI diet (increased glucose excursions) and a low GI diet ( blunted glucose) over 24 hours in healthy Asians. Obesity and diabetes rates are increasing exponentially in Asian populations and Singapore is no exception. Devising ways and means to staunch the escalation is therefore a priority. The findings of the research will contribute towards the long-term objectives of developing Asian specific dietary guidelines for weight and glycaemic control. The study data will also be important for the provision of practical food-based advocacy for better weight and glycaemic control in Singaporeans.

Eligibility Criteria:
Inclusion Criteria:

* Chinese, male
* Age between 21-40 years
* Body mass index between 17 to 25 kg/m2
* Normal blood pressure (\<140/80 Hgmm)
* Fasting blood glucose \< 6 mmol/L

Exclusion Criteria:

* Having any metabolic diseases (such as diabetes, hypertension etc)
* On prescription medication
* Having glucose 6-phosphate dehydrogenase deficiency (G6PD)
* Partaking in sports at the competitive and/or endurance levels
* Allergic/intolerant to any of the test foods
* Intentionally restricting food intake
* Smoking
A Study on Evaluating the Safety of HST101 in Healthy Chinese Participants

This is a single-center, randomized, double-blind, placebo-controlled, single HST101 SC dose cohort study to evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics in Healthy Chinese Participants with Elevated LDL-C Levels.

The planned 30 study participants will be assigned to low- or high-dose 2 cohorts and 15 participants in each cohort will be randomized to either the HST101 group or the matching dose placebo group and will be administered in subsequent or in-parallel manner. Cohort 1: 15 study participants will receive the low dose of HST101 or placebo at a corresponding dose. Cohort 2: additional 15 study participants will receive the high dose of HST101 or placebo at a corresponding dose.

Eligibility Criteria:
Inclusion Criteria:

* Men and women who are ≥18 and ≤55 years of age with elevated LDL-C Levels;
* LDL-C ≥ 2.6 mmol/L (100 mg/dL) and ≤ 4.9 mmol/L (190 mg/dL) and TG ≤ 2.83 mmol/L (250 mg/dL) who are not on a lipid-lowering therapy 30 days prior to screening;
* Body mass index (BMI) ≥18 and≤28 kg/m2

Exclusion Criteria:

* Positive blood screen for HIV antibody, Treponema pallidum antibody, HBsAg or HCV antibody;
* Clinically significant liver function test abnormalities at screening, such as AST or ALT \> 2 × ULN, total bilirubin \> 1.5 × ULN, or ALP \> 2 × ULN based on normal values;
* CK \> 3 × ULN at the screening visit, it can be retested if considered to be related to exercise;
* History of prescription drug abuse, illicit drug use or alcohol abuse;
* Use of any prescription drug, herbal and compound decoction, vitamins, minerals, and OTC drugs and nutritional supplements that alter lipid metabolism within 14 days prior to Check-in and planned use of the above drugs throughout the study;
* Prior treatment with PCSK9 inhibitors, including mAbs, siRNA products, or any Adnectin products;
* History of allergy to protein-based biologics including, but not limited to, mAbs and vaccine;
* Less than 30 days or less than 5 half-lives (drug) since the end of participation in another clinical trial (drug or device), whichever is longer;
* Use of any other biologics within 3 months prior to investigational product administration;
* Any other significant clinical diseases or psychological diseases that the investigator considers to be inappropriate for participation in this study.
The Immediate Effect of Sacroiliac Joint Manipulation in Standing Workers

The aim of this study was to determine whether sacroiliac joint manipulation has a positive effect on muscle strength, balance and range of motion in standing workers.

The study included 40 participants who were previously informed about the study, met the inclusion criteria and signed the consent form. Participants were randomly divided into two groups as sacroiliac joint manipulation group (n=20) and control group (n=20). Hip and lumbar range of motion was assessed with a goniometer, postural control and balance with Biodex, and quadriceps femoris and hamstring muscle strength with MicroFet®2. The sacroiliac joint manipulation group underwent sacroiliac joint manipulation and the control group did not undergo any procedure. The effect of the manipulation was measured immediately after the manipulation and the significance level was accepted as p\&lt;0,05.

Eligibility Criteria:
Inclusion Criteria:

* Having signed the voluntary consent form
* Being between the ages of 18-50
* Working standing for at least 3 hours a day
* Working standing for at least 6 months
* Suffering from low back pain in the last 6 months.

Exclusion Criteria:

* Having diseases that may cause balance problems
* Having a history of trauma in the last 6 months
* Pregnancy or suspicion of pregnancy
* Contraindications to chiropractic treatment (such as tumor, rheumatological condition, fracture, dislocation, metastasis and aneurysm)
* Feeling pain in the pelvis and sacroiliac joint,
Trial of Enzastaurin and Bevacizumab in Participants With Recurrent Malignant Gliomas

The purpose of this study is to evaluate both enzastaurin and bevacizumab in the treatment of recurrent malignant gliomas.


Eligibility Criteria:
Inclusion Criteria:

* Participant must be at least 18 years old
* Participant must have been diagnosed with a recurrent brain tumor by magnetic resonance imaging (MRI) scan
* Participant must be willing to practice adequate contraception
* Participant must be able to swallow the enzastaurin tablets whole and receive bevacizumab intravenously
* Participant must agree to use the study drug only as instructed by your study doctor and staff.

Exclusion Criteria:

* Women who are pregnant or breastfeeding
* Participants who have significant heart, liver, kidney, or psychiatric disease
* Participants who have an active infection
* Participants who have any recent bleeding in the brain
* Participants who are taking any anti-coagulation or anti-platelet medication \[including aspirin, non-steroidal anti-inflammatories, Cyclooxygenase-2 (COX-2) inhibitors\]
Encouraging Positive Parenting Habits Through Digital Media

This study evaluates the feasibility and preliminary impacts of a new parenting program consisting of a series of educational videos, delivered via a popular texting platform. For this pilot project, the program content is focused on teaching parents strategies to better manage one of the commonly reported challenges that children face, a transition to a non-preferred activity. Parents with young children demonstrating behavior consistent with ADHD and experiencing difficulties with daily transition routines are invited to participate in the study.

This pilot study employs a pre-post, open trial design with the primary aim to investigate the feasibility of delivering parenting educational materials in a highly accessible format, i.e., a widely used texting platform. The training videos demonstrate the applications of antecedent- and reinforcement-based behavior management techniques in a specific situation and encourage parents to build positive parenting habits. The program usability and satisfaction will be assessed through ratings and answers to open-ended questions by participating parents. The study targets parents of children demonstrating symptoms of ADHD. These families frequently experience difficulties managing everyday routines at home, yet the access to psychosocial treatment is limited. The investigators expect parents to engage well in the program delivered via digital media. Based on the existing literature on the effectiveness of behavior parent training delivered in traditional in-person format, a moderate effect size is expected in the pre-post measures of parenting practices and the child target behavior for this study.

Eligibility Criteria:
Inclusion Criteria:

* Parents of children, aged 4-8, who demonstrate behavior symptoms consistent with ADHD symptoms, i.e., at least 4 inattention and/or 4 hyperactivity/impulsivity symptoms (parent-report). The number of symptoms is lower than the diagnostic threshold to include those with emerging problems. No diagnosis will be made or confirmed in the study. Children need to live with the participating parents at least 5 days per week every week.

Exclusion Criteria:

* Parents of children who have received other forms of pharmacological and/or non-pharmacological treatment in the past 3 months. These parents will be asked to wait to receive other forms of treatment until they complete the study participation.

Parents of children demonstrating symptoms consistent with Autism Spectrum Disorder, and those other difficulties (severe learning, mood and anxiety problems and environmental issues \[e.g., recent divorce\]) that would better explain the child's challenges transition routines.