cyrilzakka/clinical-trials huggingface dataset:
The Effect of an Alginate Based Beverage on Weight Loss

The project aims to examine the efficacy of a 12-week intake of alginate based ready to drink supplement on development in body weight and body composition, and risk markers for type-2 diabetes and cardiovascular disease in obese subjects.

The study consists of a parallel RCT with 96 overweight/obese subjects enrolled into two treatment arms: placebo or active for 12 weeks. They will undergo examination at time points 0 and 12 weeks where a DXA scan will be performed to assess body composition and a fasting blood sample will be taken. At time points 0, 2, 4, 6, 8, 10 and 12 weeks their weight and waist circumference and number of test products not consumed will be recorded. In addition all subjects receive dietary counselling during the 12 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Healthy men and women
* Overweight to obese (BMI 28-45 kg/m2)

Exclusion Criteria:

* Chronic diseases including:liver and kidney disease, including P-Alanine aminotransferase (ALT), P-aspartate aminotransferase (AST), gamma-glutamyltransferase (GGT), creatinine kinase and P-lactate dehydrogenase (LD)\> 2.0 times the upper limit of normal (ULN) (measured at the screening at the Department of Human Nutrition)
* systemic infections and metabolic diseases that can interfere with energy balance,
* diabetes or fasting blood glucose concentration\> 7.0 mM, cardiovascular disease, systolic blood pressure ≥ 160 and / or a diastolic blood pressure ≥ 100 mmHg, hyperlipidemia (total cholesterol\> 6.5 mM and triglycerides\> 5.0 mM) (measured by the screening at the Department of Human Nutrition)
* Food allergies
* Psychiatric disorders and any clinical condition that makes the person unfit to participate in the experiment
* Use of dietary supplements (during the experimental period and 3 months before study start)
* Provision of blood for example. of donation or other scientific studies (during the trial and 3 months before study start) and hemoglobin \<7.5 mmol / l (measured at the screening at the Department of Human Nutrition)
* Smoking (throughout the trial and 6 months before study start)
* Elite Athletes (\> 10 hours strenuous exercise per week, self-reported)
* Women who are pregnant or breastfeeding, and post-menustruelle (self reported)
The Effect of ACT and Float REST on Burnout Syndrome.

In 1982, Steven Hayes, a clinical psychologist, developed Acceptance and Commitment Therapy (ACT), a unique empirically based psychological intervention that uses acceptance and mindfulness strategies, together with commitment and behavior change strategies, to increase psychological flexibility. In 1954, John Lilly, a cognitive neuroscientist, developed the sensory deprivation tank (known today as Floatation Restricted Environmental Stimulation Therapy - Float REST), to access a wide range of healing, higher brain functions, and meditation through an unparalleled deep relaxation state. In this study, the investigators aim to examine whether participants in the ACT + Float REST condition will have larger decreases of the burnout phenomenon than those who receive either only ACT or Float REST.


Eligibility Criteria:
Understanding the Role of Dietary Fatty Acids on Liver Fat Metabolism in Humans

High levels of fatty substances in the blood increase the risk of developing heart disease. Investigators know a lot about one of these fatty substances, cholesterol. However, there is another fatty substance in the blood called triglyceride. Investigators do not understand much about what regulates the rate at which the liver produces triglyceride and liberates it into the bloodstream after eating a meal(s). It is known that taking fish oil lowers the amount of blood triglyceride however, it remains unclear how this happens. Investigators will study if changes in liver fat metabolism, after taking fatty acids found in fish oil (n-3 fatty acids)can explain the lowering of blood triglyceride. Investigators also want to know if taking fish oil alters the amount of fat that accumulates within the liver.

Investigators will recruit men and women with no medical condition or relevant drug therapy that affects liver fat metabolism.

Purpose and design:

Investigators are asking the research question: "How do specific fatty acids, such as those found in fish ((n-3) fatty acids) influence postprandial liver fat metabolism?"

It is known that n-3 fatty acids lower plasma triglyceride concentrations but it remains unclear how this happens.

To address this research question investigators want to undertake detail physiological studies, in a randomised study where individuals will be studied before and after taking n-3 fatty acids or a placebo oil.

Eligibility Criteria:
Inclusion Criteria:

* Participant is willing and able to give informed consent for participation in the study.
* BMI \>19 \<35kg/m2
* No medical condition or relevant drug therapy known to affect liver metabolism

Exclusion Criteria:

* Age \<18 or \>65 years
* Body mass index \<19 or \>35kg/m2
* A blood haemoglobin \<120mg/dL
* Any metabolic condition or relevant drug therapy
* People allergic to fish / seafood or nuts
* Smoking
* History of alcoholism or a greater than recommended alcohol intake
* Pregnant or nursing mothers
* Women prescribed any contraceptive agent or device including oral contraceptives, hormone replacement therapy (HRT) or who have used these within the last 12 months
* History of severe claustrophobia
* Presence of metallic implants, pacemaker
* Haemorrhagic disorders
* Anticoagulant treatment
Nation-wide Hepatitis C Virus (HCV) Registry in Taiwan

To determine the treatment efficacy, safety and long-term outcomes of chronic hepatitis C patients receiving directly acting antivirals in Taiwan

The National Health Insurance Administration (NHIA) in Taiwan supports the use of antivirals against CHC. Recently, the introduction of directly acting antivirals (DAA) has markedly improved the treatment adherence, efficacy and safety issues in well-designed clinical trials. However, the real world community effectiveness and long-term benefits of DAA for HCV treatments remain to be determined. Since the NHIA in Taiwan has reimbursed the DAA in the treatment of chronic hepatitis C (CHC) patients in the near future, establishment of a well prospectively designed registry policy is demanded in the national level to explore the unmet needs of HCV control in Taiwan. The primary purpose of the study is to establish a nationwide registry of patients undergoing antiviral treatment with DAA regimens for CHC at both academic and community practices. Based on this database, the clinical gaps regarding to treatment guidelines and management of adverse events will be identified. The registry system will be established as a research network and provide sufficient high-quality clinical information for investigators in Taiwan.

Eligibility Criteria:
Inclusion Criteria:

1. Patients who are treated with DAA and have willingness to participate in this registry.

Exclusion Criteria:

Chronic hepatitis C patients who are unwilling to participate in the study and do not provide written informed consent for participation.
The Effect of Allergen Immunotherapy on Exhaled Nitric Oxide in Adult Patients With Asthma and Allergic Rhinitis

This study will evaluate whether exhaled nitric oxide levels are affected by allergen immunotherapy ("allergy shots"). The investigators' hypothesis is that successful allergen immunotherapy may be accompanied by decreased exhaled nitric oxide levels.


Eligibility Criteria:
Inclusion Criteria:

* Subjects over 18 years old with allergic asthma and/or allergic rhinitis who are beginning allergen desensitization

Exclusion Criteria:

* Smokers
* Subjects of dimished capacity
End-of-life Decision-making Among Young Patients With Advanced Cancer: a Grounded Theory Approach

The purpose of this qualitative research is to use grounded theory to explore and describe the thoughts of young advanced cancer patients regarding end-of-life care and how these thoughts influence the related decision-making process.


Eligibility Criteria:
Inclusion Criteria:

* The patient has a solid tumor.
* The age at initial cancer diagnosis is between 15 and 39 years.
* The patient is at least 18 years old at the time of enrollment.
* The patient has cancer with metastasis, either present at initial diagnosis or occurring after treatment or follow-up.
* After metastasis, the first-line curative treatment is ineffective.

Exclusion Criteria:

- Patients who, for any reason, including severe psychological distress (as determined by the attending physician, psychiatrist, or specialist nurse based on assessments and impressions during routine patient care), cognitive impairment, or physical limitations (such as frailty), are unable to communicate or participate in an interview lasting more than 30 minutes.
Learning for Hearts and Minds in Elementary School

ABSTRACT- Introduction: Skills such as recognizing and managing emotions, developing empathy, building cooperative relationships, solving problems effectively and obtaining communication skills have gained importance in several schools and this has been made possible by Socio-Emotional Learning (SEL). Robust studies in this area in Latin America are lacking, and what happens in the brain and in our general physiology, from trainings related to SEL, needs to be better understood. Objectives: To assess the effects of Learning for Hearts and Minds Training (TACM) on positive and negative affect, empathy and compassion, emotional expression, self-compassion, life satisfaction, sense of community in the classroom, academic goals, school performance, brain activity and heart rate variability in 4th and 5th year elementary school students. Methods: This is a randomized controlled trial in clusters with cross-over, in approximately 600 students. By the end of the first semester, one group of students will receive the TACM and the other will be a waiting control group. In the second semester, the latter will receive the TACM and the former will continue the TACM practices. The groups will be evaluated in 5 moments during the year. A classroom will be randomly assigned to undergo an assessment of brain activity and cardiac variability to assess their ability to regulate emotions. Students, parents and teachers will be drawn for a qualitative interview at the end of the academic semesters about the effects of TACM.


Eligibility Criteria:
Inclusion Criteria:

* Students of selected public schools of Junidaí of the 4th and 5th grade of Brazilian elementary School

Exclusion Criteria:

-
Open-label, Single Arm Trial of BI 695502 in Patients With Previously Untreated Metastatic Colorectal Cancer

The objective of this trial is to evaluate the safety and tolerability of BI 695502 in combination with leucovorin/5-fluorouracil/oxaliplatin (mFOLFOX6) and as maintenance therapy (when applicable). As well as to evaluate the following efficacy parameters: Progression-free survival (PFS), objective response rate (proportion of patients with complete response \[CR\] plus partial response \[PR\]), overall survival (OS), duration of response (DOR), time to progression (TTP).


Eligibility Criteria:
Inclusion criteria:

* Males and females aged \>=18 years (for Japan only: Age \>=20 years at time of signing Informed Consent Form) with histologically confirmed metastatic colorectal cancer (mCRC).
* Metastatic disease not amenable to surgical curative treatment and eligible to receive therapy with mFOLFOX6 (Leucovorin/5-Fluorouracil/Oxaliplatin) + bevacizumab.
* At least one measurable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1.
* Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1.
* Adequate hepatic, renal and bone marrow function.
* Further inclusion criteria apply.

Exclusion criteria:

* Prior systemic therapy for metastatic disease
* Prior therapy with monoclonal antibodies or small molecule inhibitors against Vascular endothelial growth factor (VEGF) or VEGF receptors, including Avastin® or Avastin® biosimilar
* Previous malignancy other than Colorectal cancer (CRC) in the last 5 years except for basal cell cancer of the skin or pre-invasive cancer of the cervix
* Spinal cord compression or brain metastases unless asymptomatic, stable and not requiring steroids for at least 6 weeks prior to start of study treatment
* Any unresolved toxicity \> Common Toxicity Criteria Grade 1 (except alopecia) from previous anticancer therapy (including radiotherapy)
* History or evidence of inherited bleeding diathesis or coagulopathy with the risk of bleeding
* A thrombotic or hemorrhagic event \<=6 months prior to screening (includes hemoptysis, Gastrointestinal (GI) bleeding, hematemesis, central nervous system hemorrhage, epistaxis, vaginal bleeding, cerebral infarction, transient ischemic attacks, myocardial infarction, angina, and coronary artery disease)
* Further exclusion criteria apply
Effects of Thoracic Paravertebral Block Combined With S-ketamine on Postoperative Pain and Cognitive Function After Thoracoscopic Surgery

To investigate the effect of ultrasound-guided thoracic paravertebral nerve block combined with intraoperative infusion of s-ketamine on postoperative acute pain and cognitive function in patients with thoracoscopic surgery

A total of 120 patients who were admitted to Qinhuangdao First Hospital for and divided into control group (group C ), thoracic paravertebral nerve block combined with full Anesthesia group (group TA), thoracic paravertebral nerve block combined with intraoperative infusion of s-ketamine group ( group TE). 40 cases in each group. Group C received general anesthesia, group TA received 0.375% ropivacaine 20ml thoracic paravertebral nerve block combined with general anesthesia under ultrasound guidance after anesthesia induction, and group TE received s-ketamine anesthesia induction dose of 0.3 mg/kg on the basis of TA group. Anesthesia maintenance dose of 0.2ug/kg/h was pumped to 30min before the end of the operation. The MAP(Mean Artery Pressure) and HR(Heart Rate) of the three groups were recorded before surgery (T1), during the surgery (T2), immediately after surgery (T3). Compare the VAS（Visual analogue scale）in the ten minuses after extubation and one day afte surgery .The cognitive function of the three groups were evaluated by the Mini Mental State Scale (MMSE) on one day before surgery , one day after surgery , and three months after surgery . Compare the incidence of Postoperative Cognitive Disfuntion（ POCD） among the three groups.

Eligibility Criteria:
Inclusion Criteria:

* 18-24kg/m2
* American Society of Anesthesiologists (ASA) grades I-III
* The score of Mini Mental state examination≥24

Exclusion Criteria:

* Patients with heart, lung and other vital organ disorders
* The score of Mini Mental state examination≤23
* Preoperative psychiatric disorders or long-term use of drugs affecting the psychiatric system
* Have severe visual, hearing, speech impairment or other inability to communicate with the visitor
* Refuse to sign informed consent
Autologous Fat Augmentation of Orbital Volume Using a Closed Cannula Technique

After enucleation or evisceration with placement of a dermis fat graft or integrated orbital implant as a primary procedure, there can be secondary loss of orbital fat volume causing regression of periocular tissue and malpositioning of the cosmetic shell. Current techniques for correction require open surgery to place a sheet/block of biocompatible material or a macroaggregate of fat into the orbit to augment orbital volume for permanent correction. Alternatively, hyaluronic acid-base fillers (Restylane, Radiesse) have been injected, but these have proved to be temporary. The current study seeks to show that a permanent augmentation of orbital volume can be achieved using a closed cannula injection of autologous fat.

To date, 5 subjects have completed fat injections and 4/5 have acquired complete sets of 3 MRIs each. Data analysis has begun. The study has been extended to include 5 more subjects (total 10) to increase the number of data for analysis.

To date, the protocol has been expanded to include 10 subjects of which 6/10 have completed fat injections. The study period has been extended to include MRIs at 2 and 5 years after injection.

Eligibility Criteria:
Inclusion Criteria:

* Subjects who have developed secondary orbital fat atrophy after enucleation/evisceration with or without dermis fat grafting
* standard sphere or integrated orbital implantation
* phthisis bulbi are candidates

Exclusion Criteria:

* class 3 or greater anesthesia risk
* infection
* inability to follow study protocol
Study of External Beam Radiation Therapy With and Without Hormonal Therapy to Treat Prostate Cancer

This clinical study was to determine if the use of 6 months of total androgen suppression (hormonal therapy) when added to radiation therapy for localized-high risk prostate cancer would improve overall survival.

This was a randomized study comparing external beam radiation therapy with total androgen ablation for 6 months with radiation therapy alone. Drugs were given 2 months prior, 2 months during, and 2 months after radiation therapy. Eulexin and Lupron or Zoladex was used in this study.

Eligibility Criteria:
Inclusion Criteria:

* Biopsy proven prostate cancer
* Negative bone scan
* Lymph nodes by CT or MRI
* Adequate blood work
* Performance Status - ECOG 0-1
* Life expectancy of at least 10 years
* \>40 years of age

Exclusion Criteria:

* Prior history of malignancy
* Prior hormonal therapy or chemotherapy
* Prior pelvic radiation therapy
* Unable to tolerate lying still 5-10 minutes/day
Study of Temzolomide and Gleevec in Advanced Melanoma

This study has been designed to evaluate the side effects of Gleevec when given in combination with Temzolomide; and to learn more about how these drugs work in the body and whether this combination is useful in treating patients with melanoma.


Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed melanoma that is metastatic or unresectable and for which standard curative or palliative measures do not exist or are no longer effective
* Prior chemotherapy, immunotherapy, radiation therapy (Phase I portion only), cytokine, biologic, or vaccine therapy is permitted, however no prior treatment with temozolomide
* Measurable disease
* Performance status \<= 2
* Life expectancy greater than 3 months

Exclusion Criteria:

* No prior treatment with temozolomide or imatinib mesylate
* Organ allografts
* Prior radiotherapy, or prior intratumor injection therapy, to areas of measurable disease that are used as target indicator lesions, unless progression has occurred at that site or measurable disease has developed outside the treatment area
* Pregnancy or lactation
* History of second cancer
* Known hypersensitivity to temozolomide or imatinib
* Use of any experimental therapy within 3 weeks prior to baseline evaluations done prior to enrollment
Integration of Real-Time Motion Tracking and Pediatric Rehabilitation

Emerging technologies that utilize motion capture integrated with engaging software offer new methods for increasing engagement and movement in patients admitted to the hospital. Hospitalized patients are often limited to sedentary activities, spending the majority of their time in bed, which can contribute to deconditioning and functional mobility deficits. This study seeks to explore the feasibility of a tool designed to promote movement through engaging gameplay that is acceptable to both clinicians and families.


Eligibility Criteria:
Inclusion Criteria:

* Pediatric patients aged 6-17 years.
* Receiving physical therapy at Stanford Children's Hospital.
* Medically cleared for standing and upper-body movement.
* Ability to follow simple instructions and engage in standing gameplay.

Exclusion Criteria:

* Orthopedic or medical conditions contraindicating physical activity.
Evaluation of a Strategy for the Presentation of Oral Nutritional Supplements in Verrines for Managing Undernutrition in the Elderly Undergoing Follow-up Care and Geriatric Rehabilitation

Protein-energy malnutrition results from an imbalance between the body's intake and needs. Among the elderly in long-term care, the prevalence of undernutrition varies from 30% to 70%. It is responsible for or aggravates a state of fragility or dependence, and promotes the occurrence of morbidities. It is also associated with worsening prognosis for underlying diseases and increases the risk of death. Nutritional management of undernutrition is an issue, especially in health facilities. Among the various existing nutritional care methods, oral nutritional supplements should be considered in the event of failure of food enrichment measures or even at the outset in undernourished elderly people. However, compliance or acceptance of these products among the elderly remains limited and variable with consumption of oral nutritional supplements ranging between 48% and 94% according to studies, and, because of their ease of prescription, oral supplements are sometimes the only nutritional intervention.


Eligibility Criteria:
Inclusion Criteria:

* Undernourished or at-risk individuals with blood albumin levels below 35 g/L or prealbumin levels below 200 mg/L,
* Person admitted to geriatric follow up care less than 48 hours ago,
* Person fed orally,
* Person with a prescription for an ONS,
* Person who speaks and understands French.

Exclusion Criteria:

* Person not affiliated to a national health insurance scheme
* Person requiring enteral or parenteral feeding
* Person refusing to consume ONS
* People at the very end of their lives
3D-printed Crowns Versus Prefabricated Stainless-Steel Crowns for Intermediate Restoration of Compromised First Permanent Molars

The study will evaluate the clinical performance and both patient and parent satisfaction of 3d printed crowns versus prefabricated Stainless-steel crowns (SSCs) in compromised first permanent molars

A total of Forty permanent first mandibular molars in healthy subjects will be selected from the Pediatric Dentistry and Dental Public Health outpatient clinic.

The molars will be randomly assigned equally into two treatment groups group A 3D-printed crowns \& group B prefabricated SSCs, removal of caries with a high-speed handpiece then removal of the remaining carious lesion with excavator then glass ionomer restoration will be placed, preparation of SSCs crowns will be done in Group A by reduction of occlusal surface by about 1.5 mm, Proximally, tooth reduction is made through the mesial and distal contact areas, then roundation of line angles. Proper size of crown will be selected. It can also be helpful to measure the dimension of the contralateral tooth. A correctly fitting crown should snap or click at try in. In group B reduction will be performed on the occlusal surface using a flame stone or a wheel stone, to perform occlusal clearance. Reduction will be performed on the mesial, distal, buccal, and lingual surfaces of the tooth Then roundation of the line angles will be performed. Impression for the preparation will be taken using putty and light poly vinyl siloxane material. The preparation will be optically scanned in the lab and the restoration will be digitally designed using computer designing software. The crown will be printed using 3D printer using hybrid resin material. Crown will be checked for proper fit and cemented to the tooth by self-etch adhesive.

Eligibility Criteria:
Inclusion Criteria:

* Children included in the study should conform to the following criteria:

  1. Badly broken-down endodontically treated first permanent molar
  2. First permanent molar with extensive multi-surface caries.
  3. First permanent molar with structural developmental defects such as hypoplasia, Molar-Incisor Hypomineralization (MIH), Amelogenesis Imperfecta, and Dentinogenesis Imperfecta

Exclusion Criteria:

* Children who are uncooperative needing sedation or general anesthesia.
* Children who are physically or mentally disabled or having any medical condition that will complicate the treatment.
* Molars of poor prognosis