cyrilzakka/clinical-trials huggingface dataset:
Supervised Fitness Program for Adults With Cerebral Palsy

The purpose of this study is to compare the effectiveness of 2 community intervention approaches to maintain community mobility and walking speed in adults with cerebral palsy who have previously completed an 8 week course of physical therapy.

The proposed study will address the lifelong need for fitness in adults with cerebral palsy compared to individuals provided with a home exercise program at the end of their individualized physical therapy, individuals in the fitness group will...

Primary Hypothesis:

1. Have higher Pediatric Evaluation of Disability Inventory Computer Adapted Test (PEDICAT) scores at the +12 weeks post intervention visit
2. Increase their PEDICAT scores across the study period, while the home fitness group will decrease performance on the PEDICAT.
3. Complete the Timed Up and Go (TUG) more quickly at +12 weeks post intervention

   Secondary Hypothesis (study not powered for these variables):
4. Walk further on the Six Minute Walk Test (6MWT) at the +12 weeks post intervention visit

Eligibility Criteria:
Inclusion Criteria:

* Adults with cerebral palsy Gross Motor Function Classification System (GMFCS) level I, II, or III
* Completion of episode of physical therapy provided by the Developmental Disabilities program at Sheltering Arms within the one month prior to the baseline assessment
* Lives within the community in their own home or group housing

Exclusion Criteria:

* GMFCS level IV or V
* Unable to follow two-step directions
* Adults who have a medical or legal power of attorney who sign their health authorization
Anticoagulation Therapy After Splenectomy in Cirrhosis Patient

1. Inclusion and Exclusion Criteria Inclusion criteria: Inpatients who received laparotomy or laparoscopic splenectomy according to clinical, B-ultrasound scan, CT or MRI diagnosis of cirrhosis and portal hypertension.

Exclusion criteria:

1. ) Portal vein system thrombosis (PVST) found by preoperative color Doppler ultrasound or MRI examination;
2. ) Liver cirrhosis complicated with liver tumor;
3. ) Liver cirrhosis complicated with blood system diseases;
4. ) Patients who have not signed the informed consent form.

2. Research subgroup According to the order of the patients, the following groups are entered in turn, and the cycle is repeated.

1. ) Heparin group
2. ) Rivaroxaban group
3. ) Control group.

1. Inclusion and Exclusion Criteria Inclusion criteria: Inpatients who received laparotomy or laparoscopic splenectomy according to clinical, B-ultrasound scan, CT or MRI diagnosis of cirrhosis and portal hypertension.

Exclusion criteria:

1. ) Portal vein system thrombosis (PVST) found by preoperative color Doppler ultrasound or MRI examination;
2. ) Liver cirrhosis complicated with liver tumor;
3. ) Liver cirrhosis complicated with blood system diseases;
4. ) Patients who have not signed the informed consent form.

2. Research subgroup According to the order of the patients, the following groups are entered in turn, and the cycle is repeated.

1. ) Heparin group: Low molecular weight heparin 5000U ih Q12h was given 24 hours after operation, 5 days after operation. Warfarin 1.25-2.5 mg po qd, 30 days after operation. PT（prothrombin time）/INR（international normalized ratio） was kept at 1.25-1.5.
2. ) Rivaroxaban group: Rivaroxaban 10mg po qd from 24 hours after operation, 30 days after operation. PT/INR was kept at 1.25-1.5.
3. ) Control group: No preventive intervention measures. If platelets in the above groups are \> 500× 109/L, aspirin 100 mg qd is added for 1 month. If platelets are \> 1000× 109/L, platelet collection is performed.

3. Monitoring indicators Color Doppler ultrasound was reexamined 1, 2, 3 and 4 weeks after operation to find out whether PVST was present. Abdominal CT was performed when PVST was suspected. After the patient's condition is stable, the portal vein system ultrasound is reviewed monthly, and the follow-up time is 1 year.

Eligibility Criteria:
Inclusion Criteria:

* Inpatients who received laparotomy or laparoscopic splenectomy according to clinical, B-ultrasound scan, CT or MRI diagnosis of cirrhosis and portal hypertension

Exclusion Criteria:

* Portal vein thrombosis found by preoperative color Doppler ultrasound or MRI examination;
* Liver cirrhosis complicated with liver tumor;
* Liver cirrhosis complicated with blood system diseases;
* Patients who have not signed the informed consent form.
Effectiveness of Supplementary Feeding During Infection Among Moderately Malnourished Children

The purpose of this study is to determine whether an outpatient-based strategy of short-term, ready to use supplementary food (RUSF) among moderately malnourished children with acute infections achieves greater improvement in anthropometric measurements of wasting than usual diet.

Under nutrition is a contributing factor to at least a third of child deaths. Whilst severe malnutrition has the highest mortality risk, most malnutrition-related deaths are thought to be related to mild-moderate malnutrition.This is because moderate malnutrition is common, it directly increases the risk of death from common infectious diseases and may progress to severe malnutrition.

Malnutrition may arise from poverty, food insecurity or inadequate nutrition being offered, and may begin early in life. Malnutrition is exacerbated by the multiple effects of infectious diseases such as gastroenteritis, pneumonia, malaria or HIV. All these common infections are associated with net protein loss with diversion of essential amino acids to producing acute phase and immune response proteins. Fever is associated with an increased resting energy expenditure of 7 to 13% per degree Centigrade. Activation of inflammatory cascades also causes reduced appetite and loss of lean tissue and fat. Acute infection is therefore associated with growth faltering, resulting in a vicious cycle. Acute infection is therefore a potential target for intervention to interrupt the vicious cycle between malnutrition and infection in children.

This study aims to evaluate a strategy of giving short-term RUSF as a supplement to usual diet at home, without daily observed feeding, administered through existing health services at Kilifi District Hospital, Kenya. RUSF has a very low moisture content and is essentially a lipid-enveloped paste, it is microbiologically stable with a long shelf life at tropical temperatures and preserves delicate micronutrients such as vitamin A.

Eligibility Criteria:
Inclusion Criteria:

* Age 6 months to 5 years
* Mid-upper arm circumference (MUAC) less than 12.5 cm
* Resident in the Kilifi demographic surveillance (DSS) area
* Presentation with acute (\<5 days) illness including respiratory infection, malaria, diarrhoeal disease or other acute infection.
* If admitted, admission of \<5 days, recruited at discharge.

Exclusion Criteria:

* Severe malnutrition (WHZ score \< -3 or Kwashiorkor)
* Requiring admission to hospital in the opinion of clinician
* Known allergy to maize, soya, sorghum, milk or any RUSF components.
* Consent declined
* Underlying condition precluding assessment or inclusion
* Any other reason why the consenting investigator thinks it is not appropriate for them to take part.
A Study of Changes in Bone Mineral Density as a Function of Consuming Two Different Forms of Calcium Carbonate

The purpose of this study is to determine whether consuming calcium carbonate that has been micronized is more effective than the traditional form of calcium carbonate in maintaining or increasing bone mineral density in people who are currently taking bisphosphonates or other bone-health medications.

Addressing the need for a form of supplemental calcium that could facilitate increases in BMD without the adverse effects often reported with limestone-based forms of calcium, a patented technology was developed to increase calcium absorbability using both Zet Mill/Ball Mill bottom-up pulverizing technology and 4D top-down ebonite charging technology to create a novel form of calcium referred to as micronized calcium carbonate (MCC). In comparison to other technologies that use water and high heat, which results in a loss of core nutrients and decreased product efficacy, the calcium produced by this unique pulverizing technology is micron-sized (0.03um - 10um) and therefore believed to be more effective. While its tiny size was thought to increase its absorption, the belief was that the intense activation of zinc via the patented ebonite charging process that could maximize the bioavailability of this calcium.

Eligibility Criteria:
Inclusion Criteria:

* Must currently be under the care of a physician and taking prescription medication for bone health
* Must ensure with medical provider that there are no medical conditions that would preclude participation
* Must be able to swallow capsules
* Must be age 21 or above
* Must agree to follow study requirements as set forth in Informed Consent

Exclusion Criteria:

* Men and women not currently taking prescription medication for bone health
* Conditions that inhibit gastrointestinal absorption of supplements
* Men and women less than 21 years of age
* Pregnant or breast feeding
Enhanced Primary Care for Elderly

The present health care situation for the elderly in many countries is insufficient and not designed according to the health care needs of the aged population. In a pragmatic multicenter primary care setting (n= 1600), the investigators use an evidence based prediction model to find elderly (75+) with high risk for complex medical care or hospitalization and apply a differentiated and directed medical and social care to this risk group, in comparison to usual care. The intervention will include all the latest evidence based tools in the care of elderly (multi-professional team, social support, medical care home-visits, telephone support, general practitioner visits, etc). The project has high potential impact on the development of future care of elderly.

In addition to the intervention study, several academic sub-studies focusing on patient's perspective, professional roles, equality, implementation and governance management of health care will be performed.

The current project is a multidisciplinary research project covering several aspects of a shift in elderly care, with outcome measures not only related to primary medical or functional measures. The analyses will widen the view to overall societal costs and effects of changes in key institutions of social security as well as to hidden mechanisms in the governance system of care and health care of elderly.

The primary aim of the present study is to investigate the extent to which a differentiated (personalized) and targeted primary care intervention provided to a statistically predicted risk population of elderly, results in care that is more effective and of higher quality than that of a control group receiving standard care. In a pragmatic multicenter primary care setting (n= 1600), an evidence based prediction model to find elderly (75+) with high risk for complex medical care or hospitalization is used followed by a differentiated and directed medical and social care to this risk group, in comparison to usual care. The intervention will include all the latest evidence based tools in the care of elderly (multi-professional team, social support, medical care home-visits, telephone support, general practitioner visits, etc).

The investigators also aim to study the care model in a broader sense; experiences of the elderly, their social networks and diversity. Finally, the project will also investigate how the health care system, from specific health care professionals (primary care nurses, doctors, para-medical staff) to management levels and politicians influence the implementation of the present and future care models. One specific subproject focuses on the mechanisms behind the inability of steak holders/politicians and top administrative executives to find efficient governance principals for elderly care and health care, despite already available knowledge sources.

Eligibility Criteria:
Inclusion Criteria:

* Age 75 years and older living in county of Östergötland

Exclusion Criteria:

* No exclusion criteria
A Multiple Ascending Dose Study of the mTOR Inhibitor (RAD001) in Combination With R1507 in Patients With Advanced Solid Tumors

This 2 part study will assess the safety, tolerability and efficacy of a combination of oral daily RAD001 and intravenous 3-weekly R1507 in patients with advanced solid tumors. In Part 1 of the study, patients will be enrolled sequentially to receive 5mg by mouth (po) RAD001 daily + 16mg/kg intravenous (iv) R1507 every 3 weeks (level 1) and if tolerated, 10mg po RAD001 daily + 16mg/kg iv R1507 every 3 weeks (level 2).In Part 2 of the study, patients with 1) advanced renal cell cancer and 2) advanced pancreatic neuroendocrine tumors will receive the maximum tolerated dose regimen from Part 1 (5mg or 10mg po RAD001 + 16mg/kg iv R1507). The anticipated time on study treatment is until disease progression, and the target sample size is 100-500 individuals.


Eligibility Criteria:
Inclusion Criteria:

* adult patients, \>=18 years of age;
* histologically confirmed recurrent or refractory advanced solid tumor (Part 1);
* advanced metastatic renal cell cancer OR advanced metastatic pancreatic neuroendocrine tumors, with evidence of progressive disease (Part 2);
* measurable disease (Part 2);
* ECOG performance status 0-2.

Exclusion Criteria:

* prior treatment with agents acting via inhibition of IGF-IR pathway;
* prior treatment with agents acting via inhibition of mTOR (Part 2);
* untreated CNS metastases;
* current anti-cancer therapy, or radiotherapy or chemotherapy \<=4 weeks prior to enrollment;
* other known malignancy requiring treatment.
Xolair in Patients With Chronic Sinusitis

The purpose of this study is to determine if treatment with the anti-IgE antibody, Xolair (omalizumab), will improve objective and subjective evidence of chronic sinusitis.

At its most basic level, sinusitis is defined as an inflammation of the lining membrane of the paranasal sinuses. Sinusitis affects all age groups, including 17% of people above the age of 65 years. On the basis of national population surveys and insurance-reimbursement claims, sinusitis is one of the most common health problems in the U.S. Thus, each year, billions of dollars are spent on direct medical costs for the treatment of this enigmatic illness.

Despite the enormous cost of the problem, there are no definite studies of treatment and management. There are some data indicating that intranasal steroids are effective, and recently Nasonex was approved for the treatment of nasal polyps. All other treatments are empirically based.

There is evidence that IgE antibodies play a role in chronic sinusitis. The investigators have shown that total IgE levels correlate with the severity of sinusitis, as assessed by CT scan. Staphylococcus enterotoxins cause local increases in total IgE in over 50% of nasal polyp patients. Allergies occur more frequently in patients with chronic sinusitis than in the general population. Elevations in total IgE have been shown to occur in patients with allergic fungal sinusitis and the levels of total IgE decrease with successful treatment. Thus, the investigators speculate that IgE contributes significantly to the pathogenesis of chronic sinusitis.

The purpose of this study is to determine if treatment with the anti-IgE antibody, Xolair, will improve objective and subjective evidence of chronic sinusitis.

Eligibility Criteria:
Inclusion Criteria:

* Chronic sinusitis, as defined by symptoms for greater than 12 weeks, despite treatment
* Paranasal sinus CT scan showing evidence of chronic sinusitis
* Positive skin or RAST test to an inhalant allergen
* Serum total IgE between 30 and 700 International Units/ml
* Body weight less than 150 kg
* Impaired quality of life, as measured by the Rhinosinusitis Disability Index (RSDI)

Exclusion Criteria:

* Women of childbearing potential not using a contraception method(s) (birth control pills, Depo Provera, double barrier) as well as women who are breastfeeding
* Known sensitivity to Xolair
* Patients with severe medical condition(s) that, in the opinion of the investigator, prohibits participation in the study (heart, lung, kidney, neurological, oncologic or liver disease)
* Use of any other investigational agent in the last 30 days
* No measurable disability on the RSDI
* Immunocompromised patients or patients with ciliary disorders
A Study Comparing Vemurafenib Versus Vemurafenib Plus Cobimetinib in Participants With Metastatic Melanoma

To evaluate the efficacy of vemurafenib in combination with cobimetinib (GDC-0973), compared with vemurafenib and placebo, in previously untreated BRAF V600 mutation-positive patients with unresectable locally advanced or metastatic melanoma, as measured by progression-free survival (PFS), assessed by the study site investigator.


Eligibility Criteria:
Inclusion Criteria:

* Participants with histologically confirmed melanoma, either unresectable stage IIIc or stage IV metastatic melanoma, as defined by the American Joint Committee on Cancer 7th edition. Unresectability of stage IIIc disease must have confirmation from a surgical oncologist
* Participants must be naïve to treatment for locally advanced unresectable or metastatic disease (ie, no prior systemic anti-cancer therapy for advanced disease; stage IIIc and IV). Prior adjuvant immunotherapy (including ipilimumab) is allowed
* Documentation of BRAF V600 mutation-positive status in melanoma tumor tissue (archival or newly obtained tumor samples) using the cobas 4800 BRAF V600 mutation test
* Measurable disease per RECIST v1.1
* Eastern Clinical Oncology Group performance status of 0 or 1
* Consent to provide archival for biomarker analyses
* Consent to undergo tumor biopsies for biomarker analyses
* Life expectancy greater than or equal to (≥) 12 weeks
* Adequate hematologic and end organ function

Exclusion Criteria:

* History of prior rapidly accelerated fibrosarcoma or mitogen-activated protein kinase pathway inhibitor treatment
* Palliative radiotherapy within 14 days prior to the first dose of study treatment
* Major surgery or traumatic injury within 14 days prior to first dose of study treatment
* Active malignancy other than melanoma that could potentially interfere with the interpretation of efficacy measures. Participants with a previous malignancy within the past 3 years are excluded except for participants with resected basal cell carcinoma or squamous cell carcinoma of the skin, melanoma in-situ, carcinoma in-situ of the cervix, and carcinoma in-situ of the breast
* History of or evidence of retinal pathology on ophthalmological examination that is considered a risk factor for neurosensory retinal detachment, retinal vein occlusion, or neovascular macular degeneration
* Uncontrolled glaucoma with intraocular pressure
* Serum cholesterol ≥ Grade 2
* Hypertriglyceridemia ≥ Grade 2
* Hyperglycemia (fasting) ≥ Grade 2
* History of clinically significant cardiac dysfunction
* Participants with active central nervous system (CNS) lesions (including carcinomatous meningitis) are excluded. However, participants are eligible if:

  1. All known CNS lesions have been treated with stereotactic therapy or surgery, AND
  2. There has been no evidence of clinical and radiographic disease progression in the CNS for ≥ 3 weeks after radiotherapy or surgery
* Current severe, uncontrolled systemic disease
* History of malabsorption or other condition that would interfere with absorption of study drugs
* Pregnant, lactating, or breast feeding women
Polypropylene vs Polyglactin in Suturing of the Lung

Comparative study comparing polypropylene and Polyglactin in suturing of the lung

Lung tear or, pulmonary laceration is an injury in lung parenchyma, said injury can be caused by several reasons:

Blunt chest trauma Penetrating trauma such as stab wounds or firearm wounds Iatrogenic, such as faulty intercostal tube insertion

Eligibility Criteria:
Inclusion Criteria:

* Patients admitted to Assiut University Hospital And will undergo surgery for lung tear repair.
* Patients admitted to Assiut University Hospital And will undergo surgery for bullectomy or lobectomy.

Exclusion Criteria:

* Patients with lung injury repaired with a stapler
Disability of Musculoskeletal Origin in Community-dwelling Elderly

Objectives: To assess the efficacy of an intervention program targeted to the elderly with recent-onset disability of musculoskeletal origin (DIMS), and to perform its economic evaluation.

Methodology: 1) Controlled randomised intervention study (3 years). Subjects: persons older than 65 in health district 7 of Madrid with acute (\< 3 months) DIMS. Intervention group patients will be attended by rheumatologists acording with clinical (diagnostic and therapeutical) protocols. Control group will receive the routine attention from the Health System. Efficacy and costs variables will be collected through monthly structured telephone interviews performed by independent personnel blinded to the intervention group. Efficacy will be measured by differences between groups regarding: 1) time to improvement in the baseline DIMS episode, 2) number of subsequent DIMS, and 3) total number of DIMS days. An economic evaluation will be performed from a societal perspective.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Musculoskeletal disorder
* Older than 64 years
* To have disability measured with a) or b):

  1. Rosser clasification: at least 4.
  2. M.Gill questionnaire: To need help from other person to dress, to tidy up itself, to walk or to stand up.
* Disability of recent onset:less than three months.(Patiens had a better functional situation before)

Exclusion Criteria:

* Recent surgery
* Dementia with no family support
* Institutionalized
A Clinical Study to Evaluate the Efficacy and Satisfaction of the Skinceuticals Skin Care Product (CE FERULIC) for Skin Repair Post Fraxel Laser Treatment

A Prospective, Single-center, Single-blind, Randomized split-face, controlled trial will be conducted. The goal of this clinical trial is to evaluate the efficacy and satisfaction of the Skinceuticals skin care product (CE) for skin repair following fraxel laser treatment and explore the medical value of fraxel laser therapy combined with Skinceuticals skin care product


Eligibility Criteria:
Inclusion Criteria:

1. Chinese subjects aged 18-65 years (inclusive);
2. Subjects with Fitzpatrick skin type II-IV;
3. Subjects with mild to moderate facial photoaging lesions, including melasma, acne scars, fine skin lines, enlarged pores, and dark photoaging problems
4. Subjects with consistent facial skin status on both sides and planned to receive fraxel laser treatment;
5. Subjects are willing to follow the requirements of the study protocol and complete the corresponding procedures;
6. Subjects understand the nature of the study and sign the informed consent form (ICF)

Exclusion Criteria:

1. Subjects with photosensitive skin or photosensitization-related diseases;
2. Subjects with a history of skin pigmentation, such as pigmentation caused by sex hormone factors (pregnancy, oral contraceptives);
3. Subjects with hypertrophic scar or scar constitution;
4. Subjects with autoimmune diseases, endocrine diseases or liver diseases that may lead to skin color changes;
5. Subjects who have received steroid/phototoxic drugs or laser treatment on the face within 3 months before enrollment;
6. Subjects with a history of sun exposure within 2 weeks prior to enrollment;
7. Subjects who are known to be contraindicated to fraxel laser therapy or CE (or allergic to other skin care components);
8. Subjects with known infection and inflammation in the intended treatment site;
9. Female subjects who are pregnant, lactating or plan to become pregnant;
10. Subjects who plan to use other drugs affecting skin color or intend to undergo other laser therapy and sunbathing during the treatment;
11. Subjects who are participating in other drug or medical device clinical trials;
12. Other subjects who are not suitable for this study as assessed by the investigator