cyrilzakka/clinical-trials huggingface dataset:
Internet-Based Treatment for Children With Traumatic Brain Injuries & Their Families: Counselor Assisted Problem Solving

This study will evaluate the effectiveness of an Internet-based psychosocial treatment in improving problem-solving, communication skills, stress management strategies, and coping among children who have had a traumatic brain injury and their families.

A traumatic brain injury (TBI) is caused by a strong blow, jolt, or penetration to the head that disrupts normal brain functioning. A TBI can range from a mild concussion to severe brain damage. Falls, assaults, and motor vehicle accidents account for more than 50% of TBIs. Physical symptoms of a TBI can be subtle to severe and can include nausea, memory loss, mood swings, blurred vision, and light-headedness. This type of injury can be very stressful for families and can result in feelings of anxiety, burden, and depression among family members. A child who experiences a TBI will often display new social and behavioral problems, leading to further parental distress and increased family dysfunction. Recent studies have shown that problem-solving interventions can reduce caregiver distress and improve child adjustment following a TBI. However, access to skilled therapists and specialized care for this kind of psychosocial treatment is often limited in many communities. In such communities, the Internet offers a new way to meet the mental and other health needs of individuals with TBIs. This study will evaluate the effectiveness of an Internet-based psychosocial treatment in improving problem solving, communication skills, stress management strategies, and coping among teens who have had a TBI and their families.

Families participating in this study will be randomly assigned to either an Internet-based counselor-assisted problem-solving (CAPS) group or an Internet resource comparison group (IRC). Participants assigned to CAPS will work with a trained counselor who will guide them through a 6-month structured online problem-solving and skill-building program via one-on-one videoconference sessions. Families assigned to IRC will receive computers, high speed Internet access, and links to brain injury information and resources, but no access to the CAPS Web site content. The effectiveness of CAPS will be assessed after treatment and at 6- and 12-month follow-up evaluations.

Eligibility Criteria:
Inclusion Criteria:

* Moderate to severe TBI that occurred within the last 6 months
* Overnight hospital stay
* English-speaking
* Parent must be willing to provide informed consent

Exclusion Criteria:

* Child does not live with parents or guardian
* Child or parent has history of hospitalization for psychiatric problem
* TBI is a result of child abuse
* Child suffered a nonblunt injury (e.g., projectile wound, stroke, drowning, or other form of asphyxiation)
* Diagnosed with moderate or severe mental retardation, autism, or a significant developmental disability
Study of Comparing of With and Without Sequential Therapy of S-1

The goal of this single arm clinical trial is to learn about sequential S-1 adjuvant therapy in patient wich locally advanced gastric cancer. The main question it aims to answer is:

• The efficacy and safety of S-1 adjuvant therapy, following D2 radical surgery and DS(Docetaxel + S-1) adjuvant chemotherapy.

All patients with locally advanced gastric cancer will received D2 radical surgery, 6 cycles of DS chemotherapy, and sequential S-1 chemotherapy up to 1 year postoperation.


Eligibility Criteria:
Inclusion Criteria:

* (1) Histologically or cytologically confirmed adenocarcinoma of the stomach or adenocarcinoma of the gastroesophageal junction;
* (2) Radical surgery (D2 lymph node dissection) for gastric cancer in our center, with postoperative pathological stage of stage III;
* (3) No significant tumor recurrence or metastasis as assessed by imaging;
* (4) Age 18 years - 75 years;
* (5) ECOG score of 0 or 1;
* (6) Laboratory tests tolerant to chemotherapy;
* (7) Hematological examination: no obvious signs of hematologic diseases, ANC ≥ 1.5 × 10\^9/L, platelet count ≥ 80 × 10\^9/L, Hb ≥ 90 g/L, WBC ≥ 3.0 × 10\^9/L before enrollment, and no bleeding tendency; (8) Biochemical examination: total bilirubin \< 1.5 times the upper limit of normal value, AST, ALT \< 2.5 times the upper limit of normal value, creatinine \< 1.5 times the upper limit of normal value.

Exclusion Criteria:

* (1) Other pathological types of tumors;
* (2) Pregnant or nursing women;
* (3) Those with a history of other malignant neoplastic disease in the last 5 years;
* (4) Those with a history of uncontrolled epilepsy, central nervous system disease, or psychiatric disorder, where the investigator determines whether the clinical severity prevents signing an informed consent form or affects the patient's compliance with oral medications;
* (5) Clinically severe (i.e., active) heart disease, such as symptomatic coronary artery disease, New York Heart Association (NYHA) class II or worse congestive heart failure or arrhythmias requiring pharmacologic intervention, or a history of myocardial infarction within the last 12 months;
* (6) Severe diabetes-related complications, such as diabetic nephropathy, diabetic ketosis, etc;
* (7) Those with digestive tract obstruction or physiological abnormalities, or suffering from malabsorption syndrome, which may affect S-1 absorption;
* (8) Those who have had gastrointestinal bleeding in the last two weeks, or are at high risk of bleeding as judged by the investigator;
* (9) Known to have peripheral nerve disease ≥ NCI-CTC AE grade 1. but with deep tendon reflexes (DTR) only;
* (10) Those requiring immunosuppressive therapy for organ transplantation;
* (11) who have received other chemotherapy regimens
* (12) Those with uncontrolled severe infections, or other serious concomitant diseases;
* (13) Allergic to S-1 or any of the study drug components.
Vitamin D and Muscle Metabolic Function

The purpose of this study is to identify the magnitude of muscle lipid redistribution and muscle oxygen use in individuals 60 years old or older following combined treatment of vitamin D repletion and aerobic training compared to vitamin D repletion alone, aerobic training alone, or no treatment.

The investigators plan to recruit approximately 56 aged individuals with vitamin D insufficiency for a 13 week trial. All subjects will be 60 years of age or older. Participants will be randomized to one of four groups: vitamin D (50,000IU/wk) + aerobic training (7 days during the 13th week); vitamin D (50,000IU/wk) + normal daily activity during the 13th week; placebo + aerobic training (7 days during the 13th week); or placebo + normal daily activity during the 13th week.

Following screening and informed consent process a physical activity questionnaire will be administered. A blood draw will then be conducted at baseline, midpoint and endpoint. Collected blood for the purposes of this study will assess vitamin D status (25(OH)D), parathyroid hormone, ionized calcium, insulin, and a comprehensive metabolic panel. At baseline and endpoint muscle lipid will be assessed using Magnetic Resonance Spectroscopy and muscle oxygen consumption will be determined using a novel hybrid diffuse optical instrument consisting of a near-infrared spectroscopy and a diffuse correlation spectroscopy. In addition, at each study time point 3 dietary recalls will be completed and physical activity will be measured using an accelerometer.

Eligibility Criteria:
Inclusion Criteria:

* Age: 60 and older
* BMI: 18.5-29
* Communicates fluently in English

Exclusion Criteria:

* Metal implant not suitable for MRI
* Any form of hormone replacement therapy
* Engage in more than 1 hr/week of vigorous activity
* Participated in a high-intensity resistance or aerobic training program in the last 3 months
* Lower extremity injury or surgery in the past 3 months
* Foot sores or bone conditions severely limiting ability to move or perform exercise or joint pain made worse by mild exercise
* Diabetes, inflammatory bowel disease, renal disease or uncontrolled hypertension.
* Currently have or had a history of cardiovascular or pulmonary disease that would preclude the involvement in the performance of exercise
* History of myopathy (including congenital myopathies)
* History of neurological conditions related to spinal derangement, disk disease, peripheral neuropathies, tremor and rigidity
* Past medical history of hyperparathyroidism, kidney stones or rhabdomyolysis
* Currently receiving treatment for vitamin D deficiency
* Vitamin D level \>30ng/mL
* Currently smoking
Connecting People Implementation Study

This study aims to investigate if the Connecting People (CP) Programme can be implemented by social care practitioners with high fidelity in community mental health teams (CMHTs) and improve the resourcefulness of social networks of people with mental health problems.

People with mental health problems require a range of support to help them in their recovery. Alongside medical and psychological support, people may need support with engaging in meaningful activities and developing relationships. The focus of this study is on advancing understanding of how services can improve the support they offer to people around social relationships.

In a previous study, a Connecting People programme was developed which supported people to make plans for developing their network of contacts in the community. When delivered fully, it helped people feel more included in society and better able to access advice, information and practical support from people they know.

This research project aims to look at how Connecting People can be effectively established within community mental health teams by social workers trained as part of the 'Think Ahead' initiative. The investigators want to know how to implement the Connecting People programme well, assessing whether tools such as manuals, guidance and specific training help or hinder this process. The investigators want to know when implemented, compared to standard care, whether the programme benefits mental health service users and is cost-effective.

The study will last 15 months and is organised into two phrases:

1. Implementation of the programme in community mental health teams in five areas in England. Outcome data will be collected from each participating team and results will be compared between teams who implemented the programme and those that only offered standard care.
2. Exploration of how successful implementation was across the five areas, using a check-list and in-depth individual and group interviews to understand the features that supported or hindered the process.

Eligibility Criteria:
Inclusion Criteria:

* Adults with mental health problems under CMHTs

Exclusion Criteria:

* Children
* Adults with mental health problems who are not under CMHTs
the Influence of Tidal Volume to Lung Strain

Measure the lung strain in different tidal volume in ADRS patients to find the relationship between tidal volume and lung strain and find the most suitable tidal volume for each patient.

Purpose:Find the relationship between tidal volume and lung strain in ARDS patients.Then find the most suitable tidal volume for each patient according to the dividing value.

Methods:Measure the lung strain in the tidal volume of 6mL/kg,8mL/kg,10mL/kg and 12mL/kg in each ARDS patient.

Hypothesis:With the increase of the tidal volume,the lung strain develops.In the patient with larger lung compliance,the strain of the group of conventional tidal volume is less than 0.27 and there is no obvious difference between the group of small tidal volume.

Eligibility Criteria:
Inclusion Criteria:

1. Age:18-85,gender is not limited
2. Needing Invasive ventilation
3. Fit the definition of ARDS in 2012 "Berlin Definition"
4. Sign the paper of informed consent

Exclusion Criteria:

1. pregnancy and at the end stage of tumour
2. the COPD patients
3. less than 24h of mechanical ventilation
4. more than 5 days of mechanical ventilation
5. FiO2\>80%
6. presence of air leaks
7. organ dysfunction and hemodynamic instability
8. including in other research
Early Intervention to Reduce Bone Loss After Spinal Cord Injury

After a complete spinal cord injury (SCI), the patient becomes wheelchair-dependent, and the associated lack of weight-bearing and inactivity of paralysed muscles can lead to extensive bone loss in the long bones of the legs. It has been documented that the most rapid phase of bone loss is during the first year, but bone loss can continue for a number of years post-injury, leading to an increased risk of fracture in chronic SCI. Through a previous longitudinal study, in which we described rates of bone loss in the first year of SCI using peripheral Quantitative Computed Tomography (pQCT), we showed that there is a subset of patients who suffer from extremely rapid bone loss, losing up to 50% of their bone mineral density (BMD) in the first 12 months post-SCI. As a result of this work, we now know that, by performing repeat bone scans within months of injury, we are able to detect and "red-flag" those patients at highest risk of rapidly weakening bones. We propose that, once these patients have been identified, there is an opportunity to intervene with bone-stimulating interventions within months of injury, before BMD reaches dangerously low values. In this new phase of the research, therefore, we are introducing an intervention phase to the longitudinal pQCT study. For this, we aim to trial a physical intervention, Whole Body Vibration (WBV), that could potentially reduce rates of further bone loss in fast bone losers. Vibration would achieve this by acting as a mechanical stimulus for bone cells, to encourage bone formation. If shown to be successful as an early bone-stimulating intervention, it may prove to be a tool for reducing future fracture risk in patients with SCI.


Eligibility Criteria:
Inclusion Criteria:

* Motor-complete spinal cord injury (SCI)
* SCI at neurological levels C4 and below
* Within six weeks of SCI

Exclusion Criteria:

* Recent bilateral fractures in tibia and/or femur
* Previously diagnosed osteoporosis
* Pregnancy
Safety/Efficacy of Zoledronic Acid and Alendronate on Bone Metabolism in Postmenopausal Women With Osteoporosis

The aim of this study was to examine the effect of zoledronic acid and alendronate on bone metabolism as measured by biomarkers in postmenopausal women with osteoporosis.


Eligibility Criteria:
Inclusion Criteria:

- Low bone mineral density (as indicated by a "t-score" of -2.0 or lower) postmenopausal women

Exclusion Criteria:

- Previous use of oral and iv bisphosphonates, parathormone, strontium ranelate, sodium fluoride.

Other protocol-defined inclusion/exclusion criteria applied to the study.
A Safety and Effectiveness Study of CNTO 1275 in Patients With Moderate to Severe Plaque-type Psoriasis

The purpose of this study is to evaluate the efficacy and safety of initial single and multiple subcutaneous injections of CNTO 1275 in the treatment of patients with moderate to severe plaque psoriasis.

This is a randomized (the study medication is assigned by chance), double blind (neither physician nor patient knows the treatment that the patient receives), parallel-group, multicenter study to determine the effectiveness and safety of two different doses of CNTO 1275 administered subcutaneously one time or as multiple doses as compared with placebo in patients with moderate to severe plaque-type psoriasis (the most common type of psoriasis). The dose of CNTO 1275 will be 45 or 90 mg administered subcutaneously once or as four weekly doses. Patients who inadequately respond to their treatment may receive one additional dose. Patients will be monitored for the safety throughout the study.

Eligibility Criteria:
Inclusion Criteria:

* Have had a diagnosis of plaque-type psoriasis at least 6 months
* Plaque-type psoriasis covering at least 10% of total body surface areas
* Psoriasis area-and-severity index score of 12 or greater
* Considered by treating dermatologist to be a candidate for phototherapy or systemic treatment of psoriasis
* Women of childbearing potential and all men must agree to use adequate birth control measures
* Have no history of latent or active tuberculosis

Exclusion Criteria:

* Currently have nonplaque forms of psoriasis or drug-induced psoriasis
* Women who are pregnant or nursing, or men and women planning pregnancy while enrolled in the study
* Patients who have a history of chronic or recurrent infectious disease or who have or have had a serious infection requiring hospitalization or intravenous antibiotics within the previous 2 months
* Patients who have or ever have had a nontuberculous mycobacterial infection or opportunistic infection
* Patients known to be infected with human immunodeficiency virus, hepatitis B, or hepatitis C
* Patients who have current signs or symptoms of severe, progressive, or uncontrolled renal, hepatic, hematological, gastrointestinal, endocrine, pulmonary, cardiac, neurologic, cerebral, or psychiatric disease
* Have any known malignancy or have a history of malignancy within the previous 5 years (with the exception of basal cell carcinoma of the skin that has been treated with no evidence of recurrence)
Comparative Efficacy of Different Mebendazole Polymorphs in the Treatment of Soil-transmitted Helminth Infections

Mebendazole tablets which are produced by most pharmaceutical manufacturers, including the State Pharmaceutical Manufacturing Corporation (SPMC) of Sri Lanka, contain a mixture of polymorphs A and C. However, there is some evidence to show that mebendazole polymorph C is the only form effective against the soil-transmitted helminths. This protocol describes a stratified, randomized, placebo-controlled trial that examined the efficacy of different mebendazole polymorphs produced by the SPMC in the treatment of hookworm infections.

Mebendazole has three polymorphic forms, identified as A, B and C. All of them are in accord with the US Pharmacopeia specifications (USP XXI) but they have distinct physiochemical characteristics (Himmelreich et al, 1977) and different therapeutic activities in experimentally infected mice with Trichinella spiralis infections (Rodriguez-Caabeiro et al, 1987). The original mebendazole tablets which were used to treat human infections had more than 90% of polymorph C (Van den Bossche et al, 1982), but most pharmacopeias currently do not specify the proportion of polymorph C that a tablet of mebendazole should contain, and the assay specified for measurement of the active ingredient measures all polymorphs together. There is some evidence to show that unlike polymorph C, polymorph A is ineffective in the treatment of hookworm and whipworm infections (Charoenlarp et al, 1993). The State Pharmaceutical Manufacturing Corporation of Sri Lanka produces both 500 mg and 100 mg tablets of mebendazole according to specifications laid down in the US Pharmacopeia. These tablets contain a mixture of polymorphs A and C. It is possible that increasing the content of mebendazole polymorph C in single dose tablets may improve cure rates and egg reduction rates, especially against hookworm and whipworm infections, where much variation in efficacy has been observed.

Eligibility Criteria:
Inclusion Criteria:

* Necator americanus infection, as determined by examination of a single faecal smear, alone or with Ascaris lumbricoides or Trichuris trichiura

Exclusion Criteria:

* Children below the age of 2 years
* Pregnant women
* Individuals with diarrhea on day of treatment
Oral Fluid Intake After Extubation

According to the current guidelines the patient is not allowed to drink any fluid at least 2 hours after extubation to prevent complications. However there is no evidence in the literature to support this approach. Because anaesthetic drugs and their side effects changed significantly from their first usage, the investigators can assume that existing approach is obsolete and has no place anymore in the modern medicine. Keeping patient n.p.o (nothing per os) for 2 hours after extubation may lead to patient´s thirst or other discomfort. The aim of the study is to detect whether early oral fluid intake after extubation could lead to safe relief of thirst and to better patient´s comfort overall.

Everything stated in the brief summary.

Eligibility Criteria:
Inclusion Criteria:

* patients with planned extubation assigned to the study
* able to swallow the fluid
* willing to participate the study

Exclusion Criteria:

* patients after upper digestive tract surgery
* patients after trachea surgery
* patients with possible neurological deficiency
* patients after VIII. cranial nerve surgery
* patients not able to swallow
Effect of Maternal Supplementation from Preconception to Lactation on Child Growth and Development

The goal of this observational study is to learn about the long-term effects of maternal multiple micronutrient supplementation from preconception through to lactation on child neurodevelopment and growth in a resource-limited setting where there is a high burden of malnutrition. The main questions it aims to answer are:

* Does maternal multiple micronutrient supplementation from preconception through to lactation compared to the standard of care have an effect on child neurodevelopment?
* Does maternal multiple micronutrient supplementation from preconception through to lactation compared to the standard of care have an effect on child growth?

This is a cross-sectional follow up study to a substudy of breastmilk composition and infant growth within the Matiari emPowerment and Preconception Supplementation (MaPPS) Trial, wherein mothers were randomized to receive a multiple micronutrient supplement from preconception through to lactation or the standard of care (ClinicalTrials.gov Identifier: NCT04451395).


Eligibility Criteria:
Inclusion Criteria:

* Child participated in the MaPPS Trial Breastmilk Sub-study at 3-months of age
* Child has reached their fourth birthday
* Child is available in the study catchment area (Matiari District)
Postoperative Pain Treatment in Total Hip Arthroplasty: A Study to Assess the Effect of Local Analgesia

The purpose of this study is to determine whether the investigator standardized pain treatment plus local pain treatment is more effective than the investigator standardized pain treatment plus placebo in total hip arthroplasty.


Eligibility Criteria:
Inclusion Criteria:

* Scheduled for an uncemented unilateral Total Hip Replacement because of osteoarthritis
* Willingness and possibility to follow the instructions of the study
* 18 years or older
* written informed consent and authority after it has been read and understood.

Exclusion Criteria:

* Operation with anterior approach or using navigation
* Do not understand or speech danish
* Can not use the pain-score Numerical Rating Scale (NRS)
* Special indications for Total Hip Replacement
* Anaesthetized in general anaesthesia where a tube is demanded
* Daily use of strong opioids, based on the investigators assessment
* Fertile women
* ASA-score: 3 and 4
* Known allergy against the standardized pain treatment, the study drugs and placebo, Ropivacaine, Ketorolac, Adrenalin.
* Treatment with Lithium, Dihydroergotamin, full anticoagulant treatment or MAO-inhibitor
* Following illness:
* Active gastric ulcer or earlier gastrointestinal bleeding, ulceration or perforation of any kind.
* Suspicions of manifest gastrointestinal bleeding and/or cerebrovascular bleeding
* Haemorrhagic diathesis
* Coagulation disorder
* Severe thrombocytopenia
* Severe heart insufficiency
* Severe risk of postoperative bleeding or delayed haemostatic
* Myocardium hypertrophy or ischaemic heart disease
* Hypertension
* Hypovolemics
* Anhydration
* angiooedema
* Asthma
* Bronchospasm
* Severe liver insufficiency
* Rhinostenosis because of polyostotic
* Narrow-angled glaucoma
* Phaeochromocytoma
* Low plasm-potassium
* Thyreotoxicosis