cyrilzakka/clinical-trials huggingface dataset:
Rheumatism and Dietetic: RHUMADIET Study (Food Practices and Beliefs)

Cross sectional study assessing food practices and beliefs in RA, AS and DA (digital arthritis)

To investigate in patients having rheumatoid arthritis (RA), or axial spondyloarthritis (AS) or digital osteoarthritis (DA) practices and beliefs about influence of food and diet on their rheumatic disease.

200 patients of each disease will be included in this cross-sectional non interventional study Factors associated with specific practices or specific beliefs will be determined.

Only questionnaires are used in this study.

Eligibility Criteria:
Inclusion Criteria:

* Over 18 years of age
* Rheumatoid arthritis (RA) according to ACR/EULAR criteria or axial spondyloarthritis (AS) according to ASAS 2009 criteria or digital osteoarthritis (DA) according to ACR criteria.

Exclusion Criteria:

* Severe upper functional or psychiatric disorders
* Patients under guardianship or trusteeship
* Patients unable to answer the questionnaire in French
A New Conception About Individualized Treatment Allocation for HCC

The current guidelines on hepatocellular carcinoma (HCC) aimed to build effective prognostic stratification strategies to guide therapeutic allocation; however, the current guidelines did not consider the simultaneous comparison of distinct therapies in similar populations. Here, the investigators aimed to develop and validate a new, integrated prognostic scheme for HCC patients using artificial intelligence (AI) to simulate the survival outcomes of patients allocated to different treatments.

Given that liver resection (LR) and transarterial chemoembolization (TACE) are the mainstay curative and palliative therapies for HCC, respectively, patients who underwent LR or TACE were included in the study. Various prognostic AI algorithms were modeled using data from a large multi-institutional cohort, where LR and TACE were considered independent factors. The C-index, Brier score (BS), and area under the receiver operating characteristic curve (auROC) were calculated to estimate the AI models.

Eligibility Criteria:
Inclusion Criteria

* Diagnosed with HCC
* Receiving LR or TACE therapy
* Complete clinical information
* Preserved liver function (Child-Pugh Score \[CPS\] ≤ 7)
* PS 0-1

Exclusion Criteria

* Vascular invasion or extrahepatic spread;
* Ecompensated liver cirrhosis ;
* Younger than 18 years;
* Duration of follow-up of fewer than 30 days.
Effect of Kefir on Appetite

This study aimed to determine the effect of kefir on appetite in healthy subjects. A randomized, single-blind, and 3-intervention crossover trial included 22 healthy and normal-weight (BMI 18.5-25 kg/m2) females aged 21-24 years. Participants were recruited to three test meals: an LGI-Milk, an LGI-Kefir, and an HGI-Kefir, with a one-week washout period. Appetite ratings were measured at 0, 15, 30, 60, 90, 120, 150, and 180 minutes. At the end of three hours, participants were served an ad libitum lunch meal. Then, the foods eaten at lunch were recorded and their energy and nutrient analysis was calculated.


Eligibility Criteria:
Inclusion Criteria:

* Healthy
* Normal-weight (BMI 18.5-25 kg/m2)
* Female
* 21-24 years

Exclusion Criteria:

* During the last three months, change more than 5 kg in body weight or following an energy-restricted diet
* Being a vegan
* Having any chronic diseases such as diabetes, hypertension, etc.
* Physician-diagnosed medications or conditions that influence metabolism
* Smoking
* Practicing endurance sports
* Having difficulties with swallowing/eating
* Lack of appetite
* Hypersensitivity for the foods understudy
* Pregnant or lactating
Denosumab and Screw Fixation for Osteoporotic Compression Fracture

Evaluation of bone mineral density and function at 1 year after screw internal fixation of osteoporotic vertebral compression fractures with desuzumab: a parallel double-blind randomized controlled clinical trial

Conduct a single-center, double-blind, randomized controlled clinical trial according to clinical Trial Reporting Standards (CONSORT). Bone mineral density and function were compared 1 year after screw internal fixation of osteoporotic vertebral compression fracture (OVCF) with desomumab versus placebo in Shenzhen People's Hospital from September, 2021 to September, 2022. The study was approved by Shenzhen People's Hospital and informed consent was signed

Eligibility Criteria:
Inclusion Criteria:• Must be age between 40 and 90 years old

* X-ray diagnosis of 1-2 vertebral compression fractures
* Dual energy X ray test bone mineral density T value less than -1
* fracture history lasted within 6 weeks
* MRI showed bone marrow edema of injured segment
* lower back pain, local spines tenderness

Exclusion Criteria:

* • Must be able to have no posterior vertebral wall fracture

  * Must be able to have no patients with intervertebral fissure
  * Must be able to have no infection
  * Must be able to have no malignancy
  * Must be able to have no neurological dysfunction
  * Must be able to have no previous use of anti-osteoporosis drugs within 6 weeks
  * Must be able to have no inability to perform magnetic resonance imaging
  * Must be able to have no prior back surgery
  * Must be able to have no other established contraindications for elective surgery
Biostimulation After Tooth Extraction

This study evaluated the effect of low-level laser therapy on postoperative pain and wound healing in children undergoing primary molar extractions 40children, 6-10 years of age, systemically healthy, and had atraumatic extraction indications of bilateral primary molar teeth were included in the study. A randomly selected tooth was extracted under local anesthesia in the first session. Only the clot formation on the socket was observed and photographed in the control group. Other group extractions were performed 2weeks later. The LLLT group was treated with a 980 nm wavelength Doctor Smile Wiser diode laser and photographed. Non-epithelialized surface measurements were performed with the ImageJ program. Pain assessment was performed with the Wong-Baker Pain Scale. Statistical analyses were performed with SPSS software.


Eligibility Criteria:
Inclusion Criteria:

* indication for tooth extraction in bilateral primary molars
* did not have any systemic disease
* the use of antibiotics and painkillers was stopped at least 12 hours ago

Exclusion Criteria:

* require complicated tooth extractions
* systemic disease
* the use of antibiotics and painkillers in 12 hours
Do AxoGuard Implants Decrease Shoulder Disability After Neck Dissections

The purpose of this study is to determine whether Axoguard nerve protectors have a role in preventing shoulder disability and pain following spinal accessory nerve sparing neck dissections.

The spinal accessory nerve is often manipulated during selective neck dissections in order to remove the fibrofatty tissues containing lymph nodes surrounding the nerve. Afterwards the nerve is left exposed without it's normal support making it vulnerable to adhesions, compression, and stretch injury. Axoguard nerve wraps have shown significant promise in preventing the recurrence of carpal tunnel following forearm surgery, and preventing impotence and incontinence following nerve sparing robotic radical prostatectomy. The investigators hypothesize that the same technology may aid in reducing shoulder disability and pain if used in spinal accessory nerve sparing neck dissections. In this prospective single blinded randomized controlled study the investigators will randomly assign patients to a control group that will not receive the AxoGuard nerve wrap, and a study group that will receive the AxoGuard nerve wrap around their exposed spinal accessory nerve(s) using a research randomization tool. The results will be stratified into groups including preoperative and postoperative stage of disease, preoperative and postoperative nodal (neck) stage, history of radiation, and whether or not level 2B was dissected. Individuals with a history of pre-existing disabling shoulder complaints, individuals under the age of 18, individuals who cannot provide their own informed consent, and individuals undergoing a neck dissection that will remove the sternocleidomastoid muscle or spinal accessory nerve will be excluded from the study. Patients will undergo preoperative shoulder assessment using the Constant-Murley shoulder outcome score at their initial clinical visit. Postoperative outcomes will be recorded at 2 weeks, 2 months, 4 months, and 6 months and measured by the Shoulder Disability Questionnaire, Rand-36 quality of life survey, pain scale, and Constant-Murley shoulder outcome score. With this study the investigators aim to show a clinically significant improvement in shoulder function following spinal accessory nerve sparing neck dissections when AxoGuard nerve wraps are used to protect the nerve. Additionally, the investigators aim to improve patient satisfaction, decrease post-op pain, and improve quality of life.

Eligibility Criteria:
Inclusion Criteria:

-Any neck dissection (cervical lymphadenectomy) that involves resection of level 2 cervical lymph nodes for malignancy and does not fall into the categories listed under the exclusion criteria.

Exclusion Criteria:

1. History of modified radical neck dissection involving removal of spinal accessory nerve or sternocleidomastoid muscle
2. History of radical neck dissection
3. History of pre- existing disabling shoulder complaints
4. \<18 years of age
5. Any individual unable to provide consent for his/her self.
6. Any individual with allergy, sensitivity, or aversion to porcine material.
Safety and Efficacy Study of Intracranially Implanted Carmustine to Treat Recurrent Malignant Glioma

The purpose of the study is to determine the safety and efficacy of intracranially implanted Carmustine in the treatment of patients with recurrent malignant glioma.

Malignant gliomas recur mostly 2 cm within originated area. Local therapies therefore become particular important. Gliadel wafer developed in the States and marketed in the developed countries is an example of such treatments. The product in this study, Carmustine Sustained Release Implant (CASANT), is similar to that of Gliadel wafer as for the API(Active Pharmaceutical Ingredient), but different as for drug delivering system. As required, the preliminary clinical studies were conducted in China. Based on the results of phase I/II , 8-10 wafers containing given dose of BCNU will be administered intracranially in this phase III to the tumor resected cavity to investigate the safety and efficacy in the treatment of recurrent malignant glioma in 212 patients.

Eligibility Criteria:
Inclusion Criteria:

* Patients must be 18 to 70 years old, signed ICF;
* At least 4 weeks after previous chemotherapy (6 weeks since nitrosoureas);
* KPS ≥ 60;
* Unilateral, Supratentorial, solitary lesion and not crossing the midline(exclude patients with little tumors near the resectable tumor even if investigators think they are single lesions)
* No obvious important organ dysfunction: Blood routine: White blood cell (WBC) ≥ 4.0×109/L, Absolute neutrophil count (ANC)≥ 1.5×109/L, Platelets≥ 100×109/L, Hemoglobin≥ 90 g/L; Hepatic function:Serum total bilirubin ≤1.5 times upper limit of laboratory normal; Aspartate aminotransferase (AST) and/or Alanine aminotransferase (ALT)\<2.5 times upper limit of laboratory normal; Renal function:Serum creatinine ≤1.5 times upper limit of laboratory normal;
* Not Pregnant or lactating for women of childbearing potential.

Exclusion Criteria:

* Tumor located at ventricular system, Open ventricle tumor cavity postoperatively;
* Concomitant with other life-threatening diseases and with life expectancy \<3 months;
* Allergic to nitrosourea drugs;
* With history of intracranial radiotherapy or implant chemotherapy;
* With serious cardiac, pulmonary, hepatic and renal dysfunction, poor glycemic control;
* Investigators thought unsuitable for enrollment.
Sugammadex Dose Finding Under Two Years Old

This is a prospective dose-finding study of sugammadex for conventional reversal of rocuronium-induced neuromuscular blockade in children under two years of age. This study will explore 50% effective dose and 95% effective dose of sugammadex for reversal of neuromuscular blockade in less than two minutes under biased coin up-and-down method.

The investigators are planning to enroll 33 patients to obtain data. The starting dose of sugammadex will be 0.5mg/kg. When the dose for a patient was not effective, the dose for next patient will be increased by 0.5mg/kg. When the dose was effective, the dose for next patient will be decreased by 0.5mg/kg or maintained, with a 1:1 of allocation ratio.

The investigators will also monitor incidence of any adverse events including residual blockade to evaluate safety of sugammadex in children younger than two years old.

Eligibility Criteria:
Inclusion Criteria:

* Childern younger than 2 years old who are scheduled to undergo surgery under general anesthesia
* American Society of Anesthesiologists Physical Status 1 or 2

Exclusion Criteria:

* History of hypersensitivity to rocuronium or any anesthetics
* Presence of cardiovascular or genitourinary disease
* Presence of severe renal dysfunction or in need of dialysis
* Presence of severe hepatic dysfunction or coagualtion disorder
* Current state of administration of neuromuscular blocking agent on admission to operating room
* Concurrent use of any medications that affect the activity of neuromuscular blocking agents
* History of malignant hyperthermia
* Refusal to enroll in the study by one or more parents
* Presence of any other reasons that investigator regards inappropriate to enroll in the study.
The Acute Effects of Meals Rich in Saturated or Unsaturated Fatty Acids on Postprandial Lipaemia in Healthy Men

Current dietary recommendations suggest that lowering intake of saturated fats or replacing it with unsaturated fats will decrease the risk of developing cardiovascular disease. Coconut oil has gained popularity in recent years but it contains 90% saturated fat, which has higher percentage of saturated fat than butter. To date, only limited studies have determined the acute effects of meals containing coconut oil on blood lipids, but findings are inconsistent. Therefore, further studies are needed to address this knowledge gap and compare the postprandial effects of test meals rich in coconut oil with other sources of saturated fatty acids such as butter and unsaturated fatty acids (vegetable oils). A cross-over, double-blind, randomised acute postprandial study will be conducted in 15 healthy men. Participants will be assigned to consume the test meals rich in saturated or unsaturated fatty acids in random order on 3 separate occasions, with 3-4 weeks between each study visit. Participants will be provided with breakfast (toast with jam and milkshake, 50g fat) and lunch (toast with jam and milkshake, 30g fat). The anthropometric, blood pressure, arterial stiffness, and breath samples will be taken for each study visit. Blood samples will be collected for the measurement of fasting lipids, glucose, insulin, inflammatory markers, whole blood culture as well as blood clotting. Breath samples are collected for the measurement of gastric emptying as well as assessment of satiety using questionnaires (100 mm visual analogue scale) completed throughout the day. The findings from this study will contribute to the evidence base on how consuming meals rich in coconut oil influence the level of blood lipids as well as other biomarkers for cardiovascular disease.


Eligibility Criteria:
Inclusion Criteria:

* Healthy men
* Aged between 30 to 70 years
* Serum triacylglycerol \< 2.3 mmol/l
* Body mass index between 19-32 kg/m2
* Total cholesterol \< 7.5 mmol/l

Exclusion Criteria:

* Females
* Smokers
* Medical history of myocardial infarction or stroke in the past 12 months
* Diabetes (defined as fasting glucose \> 7.0 mmol/l) or other endocrine disorders
* Kidney, liver, pancreas or gastrointestinal disorder
* Hypertension (blood pressure \> 140/90 mmHg), cancer, medication for hyperlipidaemia (e.g. statins), hypertension or, inflammation
* Anaemia (\<130 g/L haemoglobin)
* Taking any dietary supplements known to influence lipids/gut microbiota (e.g. plant stanols, fish oil, phytochemicals, natural laxatives, probiotics and prebiotics)
* Drinking in excess of 14 units of alcohol per week
* Planning on a weight-reducing regime
* Parallel participation in another dietary intervention study
* Any other unusual medical history or diet and lifestyle habits or practices that would preclude volunteers from participating in a dietary intervention and metabolic study
Vietnam Head Injury Study - Phase III

The Vietnam Head Injury Study (VHIS)-Phase III is a prospective, long-term follow-up study of head-injured Vietnam veterans. The purpose of this research study is to determine the long-term consequences, if any, of head injury.

The VHIS - Phase III evaluation to be conducted approximately 30 years post-injury will be devoted to examining, cutting-edge cognitive neuroscience issues and will utilize state of the art technologies to address basic research questions in the following areas: (1) Functions of the human prefrontal cortex; (2) Cognitive neuroplasticity in the aging brain; (3) Memory; (4) Long-term behavioral and psychosocial outcome; and (5) Neurological studies, including an evaluation of post-traumatic epilepsy and repeat clinical measures from Phase - II. This testing will be complemented with structural neuroimaging, electroencephalogram (EEG) and molecular genetics. The goals of the VHIS - Phase III include providing clinicians and scientists new insights into the long term recovery of function following brain injury, the role of the prefrontal cortex in executive functions, better predictors of long term outcome (including cognitive, neurological, and genetic factors), and the effects of head injury incurred in youth on aging and the development of dementia.

Eligibility Criteria:
The researchers are seeking healthy CONTROL participants.

Inclusion Criteria:

* Vietnam Veteran
* Served in active combat between 1966 - 1971
* Male

Exclusion Criteria:

* Any medical condition that would make participation detrimental to the control (i.e.: severe clinical depression, acute heart dysfunction, etc...)
* A history of severe head injury, stroke, loss of consciousness, or other significant neurological, psychiatric or medical condition that would render the subject unsuitable for the VHIS testing battery.
Safety and Efficacy Study of Fipamezole in Treatment of Motor Dysfunctions in Parkinson's Disease

The purpose of this study is to determine whether Fipamezole is effective in the treatment of levodopa-induced dyskinesia in advanced Parkinson's disease.

This study is a multi-center, double-blind, placebo-controlled, multiple dose escalating, safety, tolerance, pharmacokinetics, and efficacy study of fipamezole administered in Parkinson's disease patients who are concomitantly being treated with a combination product of levodopa with a dopamine decarboxylase inhibitor (DDI) and possible other antiparkinson medication. Approximately 30 sites in the US and India will participate in this study. The patients will be randomized into one of four treatment arms to receive either fixed or ascending doses of Fipamezole (from 30 to 90 mg tid) or placebo. For efficacy assessments, levodopa-induced dyskinesia is assessed using a standardised rating scale. Time spent in 'Off' state or in 'On' state without dyskinesia, 'On' with non-troublesome dyskinesia or 'On' with troublesome dyskinesia, is assessed using patient diaries. Impact of dyskinesia on daily activities is quantified using a PDYS-26 questionnaire. To explore potential positive or negative impact of Fipamezole on cognitive functions, the study includes two cognitive tests. Finally, the study includes investigator assessments of CGI-I scales for dyskinesia, Parkinson's disease, and clinical condition in general.

Eligibility Criteria:
Main Inclusion Criteria:

* Idiopathic Parkinson's disease.
* Levodopa/DDI associated peak-dose dyskinesia which is at least moderately disabling and present for ≥25% of the waking day (UPDRS part IV, items 32 and 33, each ≥ 2).
* Stable Parkinson's medication for at least 1 month prior to randomization.
* Hoehn and Yahr Stages 1 to 4 during 'Off' period.
* Demonstrated ability to comprehend and give informed consent.
* Ability to complete patient diary.

Main Exclusion Criteria:

* Other clinically significant conditions apart from those typically associated with Parkinson's disease.
* Intake of medication associated with exacerbation of dyskinesia or with extrapyramidal side effects and tardive dyskinesia or induction of liver enzymes; neuroleptics; or specified drugs known to be substantially metabolized through the following cytochrome P450 isoenzymes: 1A2, 2B6, 2C19, 2C9, 2D6, and 2E1.
* Use of St. John's Wort or Ginkgo Biloba within 48 hrs prior to randomization and until the last treatment day with the study medication.
* Intake of an investigational drug within 30 days prior to initial screening.
Study to Evaluate Benefits & Safety of Endourage Formula C™ Oral Drops in People With Post-Acute COVID-19 Syndrome.

This study will explore the contribution of CBD oral drops in persons experiencing symptoms of Post Acute COVID Syndrome or "PACS".

At present, conventional medical and rehabilitation therapies have not consistently been effective for people with PACS, and in fact some symptoms have been observed to worsen over time. This inconsistency in clinical response has created a need for alternative treatment options to be explored. CBD presents a novel approach that warrants further investigation.

After review and approval by an Institutional Review Board (IRB), potential study participants will be recruited from on-line support groups who have identified themselves as persons experiencing post-acute COVID-19 syndrome also known as (long-haulers syndrome).

The study will be registered on the www.clincaltrials.gov website and will accept referrals from targeted clinics who refer their patients to the investigational site listed and individuals can also self-refer to the study center team.

Subjects will be evaluated weekly using telemedicine procedures. At completion of study, there will be a 7-day and 14-day follow up telemedicine visit to assess for continued benefit and/or re-emergence of symptoms/relapse.

Eligibility Criteria:
Inclusion Criteria:

1. Age 18 years of age or older who can provide informed consent.
2. Persons who have been diagnosed with COVID-19 and now in post-acute recovery phase.
3. Persons who are in care with access to primary care for post COVID infection or PACS.
4. Ability to read and write in the English language and follow study-related procedures.
5. Ability to have mail/ study drug delivered to an address and/or P.O. Box in the recipient's name.
6. Ability to participate in telemedicine visits/communication.
7. If a woman of childbearing age, willing to use a dual method of contraception (barrier and/or hormonal).

Exclusion Criteria:

1. Active illicit or non-prescribed drug use.
2. Concomitant use of benzodiazepines.
3. Concomitant use of an immune suppressant agent, e.g., prednisone.
4. Documented history and active treatment for seizure disorder.
5. Transaminase elevation.
6. Active autoimmune disorder.
7. Hepatitis C infection (currently on therapy and/or any transaminitis elevation).
8. Hepatitis B infection (currently on therapy and/or any transaminitis elevation).
9. Human Immune Deficiency Virus (HIV-1 or HIV-2) infection that is newly diagnosed or untreated.
10. Any form of mental impairment that will/could hinder safe participation in the study.
11. Pregnancy or breast-feeding.
12. Any condition that in the opinion of the investigator would be harmful or detrimental to the participant.