cyrilzakka/clinical-trials huggingface dataset:
FOLFOXIRI as Primary Treatment for Locally Advanced Pancreatic Cancer

The study is conducted as a monocentric prospective phase II trial. Patients with unresectable stage III locally advanced pancreatic cancer (defined for extended encasement of superior mesenteric artery/celiac axis/hepatic artery or for combined venous and arterial involvement or for unreconstructible venous encasement), ECOG PS 0-1 and age 18-75 are eligible.

After multidisciplinary evaluation of resectability, treatment with FOLFOXIRI is provided for a maximum of 12 cycles with multidisciplinary evaluation of disease status every 4 cycle.

In case of tumors have deemed resectable surgery is considered. In case tumors remain unresectable, radiotherapy is evaluated after the end of chemotherapy.

Primary objective of the study is the rate of patients who become resectable and undergo radical surgical resection after chemotherapy.

Secondary objectives are: response rate, progression-free survival, overall survival, toxicity.


Eligibility Criteria:
Inclusion Criteria:

* Stage III unresectable pancreatic cancer defined for:

  * extended encasement of superior mesenteric artery or celiac axis/hepatic artery
  * both arterial and venous (portal vein/superior mesenteric vein) encasement
  * unreconstructible vessel encasement
* ECOG Performance Status 0-1
* Age 18-75
* Adequate liver, renal and bone marrow function

Exclusion Criteria:

* Evidence of distant metastases
* Cardiovascular diseases
* Contraindications to studied drugs
Effect of Mobilization With Movement on Weight Bearing Ankle Dorsiflexion Range of Motion

Limited ankle range of motion is associated with increased risk for ankle sprains, knee joint dysfunction and injury to the ACL. Therefore, it is important that researchers and clinicians understand the best treatment options to increase ankle range of motion for injury prevention. We are recruiting adults with limited ankle range of motion who are lacking current ankle injuries for a treatment investigation. All study procedures will occur on the campus of the University of South Carolina by a licensed Physical Therapist and experienced researcher.

All participants will receive the MWM intervention with weight bearing ankle dorsiflexion range of motion measured prior to the intervention, immediately following the intervention, and 24 hours (+/- 3 hours) following the intervention. The participant will first place their foot on a 16-inch box to assist in performance of the intervention by the therapist. A licensed physical therapist (PT) will then stabilize the talus for a proper joint mobilization to be performed. The therapist will then mobilize the distal tib/fib in the posterior to anterior direction at end range DF reached through a forward lunge, using a Mulligan's mobilization belt around the distal tibia-fibula. The participant will perform 3 sets of 10 repetitions of the forward lunge and the PT will perform a bout of overpressure at end range during each repetition. Two other investigators will be on either side of participant to assist with balance during the intervention if needed.

Weight bearing ankle dorsiflexion range of motion will be measured via a primary and secondary measure. The primary measurement will be use of a bubble inclinometer and the secondary measurement will be the standing ankle dorsiflexion screen (SADS).

Eligibility Criteria:
Inclusion Criteria:

* The sole inclusion criterion will be a limitation in active ankle dorsiflexion range of motion to less than 20 degrees in weight bearing in one or both ankles.

Exclusion Criteria:

* Exclusion criteria include self identified feelings of ankle instability or known diagnosis of chronic ankle instability, dermatologic conditions such as open wounds or impaired sensation which inhibit the ability to use the mobilization strap, and inability to get into the testing position or perform a lunge during the intervention.
Extending and Banding the Roux-en-Y Gastric Bypass

The Roux-en-Y gastric bypass (RYGB) has proven to be an effective treatment for morbid obesity by reducing weight and comorbidities. Extending the pouch may improve weightloss without the increase of complications. Some patients regain weight after initially good weightloss. Placing a minimizer around the pouch may prevent weight regain.

The Roux-en-Y gastric bypass (RYGB) has proven to be an effective treatment for morbid obesity by reducing weight and comorbidities. Extending the pouch may improve weightloss without the increase of complications. Some patients regain weight after initially good weightloss. Placing a minimizer around the pouch may prevent weight regain.

A prospective randomize controlled trial.

Study population: alle patients undergoing RYGB are eligible for the study. inclusion criteria are BMI 35-40 kg/m2 with one or more obesity related comorbidities, or BMI \> 40 kg/m2 without any comorbidities.

Intervention: Standard RYGB versus an extended pouch RYGB vs a banded-extended RYGB.

Eligibility Criteria:
Inclusion Criteria:

* All patients who are eligible for a primary RYGB

Exclusion Criteria:

* Bariatric surgery in medical history
* Patients with a language barrier which may affect the compliance with medical advice
* Patients with a disease not related to morbid obesity, such as Cushing or drug related.
* Chronic bowel disease for example Crohn's disease or colitis Colitis.
* Renal impairment (MDRD \<30)
* Hepatic dysfunction (liver function twice the normal values)
* Pregnancy during follow-up
* Patients with treatment-resistant reflux symptoms.
Relation Between the Increase of Peripheral Edema by Fluid Therapy and the Decrease in Microcirculatory Vesseldensity

Can videomicroscopy of the sublingual microcirculation detect the increase in edema before peripheral edema will appear? By measuring the decrease in vesseldensity after strong positive fluid balances within septic patients versus euvolemic post-cardiac surgery patients. Measuring reactance and resistance (BIVA method) to determine volume status.

Primary outcome:

- Total vessel density (TVD)

Secondary outcome:

* Fluid balance
* BIVA measurements (reactance \& resistance)

There are a lot of methods to determine if a patient is fluid-responsive, however a moment to stop fluid therapy is lacking. So the purpose of this study is to find a 'stop' moment for fluid therapy before peripheral edema will be present.

With sublingual measurements of the vessel density with the Cytocam-IDF, comparing the septic patients with fluid overload , euvolemic post-cardiac surgery patients at the arrival on the ICU and healthy volunteers we can determine if there is a decrease in vessel density during fluid loading.

To give a accurate view on fluid overload we include a bio-impedance measurement of reactance and resistance. Fluid balances are recorded very accurate by our electronic patient record.

Eligibility Criteria:
Inclusion Criteria:

* after cardiac surgery
* septic patient with a fluid balance of 4L +

Exclusion Criteria:

* recent maxillofacial surgery
Cooling Via Cryogenx Body Cooling Device

The aim of this project is to test the rate of cooling following exercise in the heat utilising the CRYOGENX Cryosuit device i) against passive cooling, and ii) to quantify the rate of cooling and compare this rate with established cooling intervention thresholds i.e. -0.11 to 0.15°C.min-1. As this project is to determine the efficacy of the intervention in populations equivalent to sporting and military personnel, these aims will be tested in young (18-40 year old) healthy male and female participants whom participate in regular physical activity. As a commercially funded project, the experimental design implemented will closely replicate that of the independent investigation into the efficacy of the CAERvest® device.


Eligibility Criteria:
The inclusion criteria are:

Aged 18 - 40 years Free from known injury, illness and disease and regular use of medications other than oral contraceptives Undertake exercise training \>3 times per week for \~30 minutes per session

The exclusion criteria are:

Pregnant Previous history of neuromuscular fatigue Previous history of heat intolerance
Study to Assess Drug Levels and Safety of BMS-986278 in Healthy Participants and Participants With Different Degrees of Hepatic Impairment

The purpose of this study is to assess the drug levels and safety of BMS-986278 in participants with mild, moderate, and severe Hepatic Impairment (HI), and in matched healthy control participants with normal hepatic function.


Eligibility Criteria:
Inclusion Criteria:

All Participants:

* Must have a body mass index (BMI) between 18 and 40 kg/m\^2 (inclusive), and body weight ≥ 50 kg.

Mild, Moderate, or Severe Hepatic Impairment Participants:

* Mild, moderate, or severe hepatic impairment (HI) or cirrhosis due to chronic hepatic disease and/or prior alcohol use.
* Mild, moderate, and severe HI participants will be enrolled according to the Child-Pugh classification score.

Matched Healthy Participants:

* Free of any clinically significant disease that would interfere with the study evaluations.
* Normal hepatic function participants will be enrolled and matched individually with HI participants with respect to age (± 10 years), weight (± 20%), sex, and race/ethnicity (Japanese and Chinese participants vs non-Japanese and non-Chinese participants).

Exclusion Criteria:

All Participants:

* History of alcohol abuse within 1 year prior to screening or regular use of alcohol within 6 months prior to screening that exceeds 7 units for women, or 14 units for men of alcohol per week (1 unit = 340 mL of beer 5%, 140 mL of wine 12%, or 45 mL of distilled alcohol 40%).
* Must not have had any prior exposure to BMS-986278.

Mild, Moderate, or Severe Hepatic Impairment Participants:

* Acute liver disease (eg, caused by an acute infection or drug toxicity).
* History of initial stage/planned liver transplantation within 6 months of screening or has received a liver transplant.

Matched Healthy Participants:

* Any significant medical condition, or psychiatric illness that would prevent participant from participating in the study.
* Other protocol-defined inclusion/exclusion criteria apply.
Genetic Variability in the Response to Warfarin at Baseline and During Induction of CYP2C9

The genetic factors associated with variability in CYP2C9 induction have not been elucidated. The hypothesis underlying this study is that following 7 days treatment with rifampicin, a known CYP450 inducer, the genetic variability in regulatory elements controlling CYP2C9 expression will be associated with the magnitude of change in INR response to warfarin and in CYP2C9-mediated warfarin metabolism.


Eligibility Criteria:
Inclusion Criteria:

* Healthy subjects

Exclusion Criteria:

* Consumption of any medication during 30 days
* Smoking
* Alcohol consumption
Healthy Parent Carers Feasibility Study

This study is a feasibility study of a peer-led group-based health promotion intervention for parent carers. It will used a parallel group randomised controlled trial design to compare a group based intervention called Healthy Parent Carers, with online resources about improving health and wellbeing.

The objectives of the study are:

1. to evaluate whether the programme can be delivered in the community, and
2. to provide information necessary to design a definitive randomised controlled trial.

The investigators aim to recruit at least 96 parent carers of children with special educational needs and disabilities aged up to 25 years in six sites in Devon, Cornwall and Somerset. Participants will be individually randomised, stratified by group delivery site when recruitment in each site is completed, to either take part in a group programme, which includes online Healthy Parent Carer programme materials (intervention), or to receive access to the online materials for self-study only (control).

The programme content is organised into 12 modules, which can be delivered over six longer (4-hour) sessions or 12 shorter (2-hour) sessions. Groups will consist of at least 6 parent carers. The participant materials will be provided online.

Demographics will be collected at baseline. Participants will complete measures of mental health, wellbeing, health-related quality of life, health behaviours, patient activation, protective factors, and resource use. These data will be collected before randomisation (baseline), at post-intervention (i.e. after the intervention arm completes the group programme), and at 6 months post-intervention.

Recruitment will be monitored in order to plan for a definitive trial. Facilitators' adherence to the Facilitator Manual and participant engagement will be monitored using a facilitator checklist at the end of the sessions and we will audio-record the training sessions and group sessions. Participants' will provide feedback on the programme to assess the acceptability of the outcome measures. The investigators will conduct interviews with a sample of participants in both study arms and a focus group with facilitators to provide insights into intervention content, delivery and experience.

Eligibility Criteria:
Inclusion Criteria:

* a) Primary carers of children who identify that their children have additional needs and/or disabilities. Participants who self-identify as primary carers are eligible. The child should be up to 25 years old (this age range is consistent with the current UK Department of Health and Department of Education Special Educational Needs \& Disability (SEND) legislation and The Children's Act);

  b) Willing and able to attend the programme group meeting session(s) on arranged dates/times;

  c) Able to access online information.

Exclusion Criteria:

* a) Not able to communicate in English.
Periodontal Therapy Effect on the Ratio of TNF-α to IL-10 in Periodontis With/Out DM

Periodontitis is a chronic inflammatory disease affecting the periodontium, characterized by irreversible damage to the gingiva, periodontal ligament, and alveolar bone. It is prevalent among adults, significantly impacting oral health and quality of life. This study investigates the effect of non-surgical periodontal therapy (NSPT) on the levels of Tumor Necrosis Factor-alpha (TNF-α) and Interleukin-10 (IL-10) in periodontitis patients with and without diabetes mellitus type II.

A single-blinded, randomized clinical trial was conducted on 36 patients with generalized periodontitis, recruited from Ain-Shams University's outpatient clinic. Patients were divided into three groups: poorly controlled diabetes with periodontitis (HbA1c ≥ 7%), controlled diabetes with periodontitis (HbA1c \< 7%), and non-diabetic periodontitis. Full-mouth NSPT was performed, and clinical parameters (Plaque Index, Bleeding Index, Pocket Depth, Clinical Attachment Level) were assessed at baseline and eight weeks post-treatment. Venous blood samples were collected to measure TNF-α and IL-10 levels using ELISA kits.

Eligibility Criteria:
Inclusion Criteria:

* Both genders. Age (20-50 ) years old. Participants willing to commit for the entire period of the trial and agreed to sign the written consent after full explanation of the study.

Generalized Periodontitis patients . Having at least 20 tooth excluding wisdoms. Systemically free according to the modified Burkett's health history questionnaire except for diabetes mellitus (Burket, Greenberg and Glick 2003).

Exclusion Criteria:

* Smokers.
* Intake of immunosuppressive drugs, antibiotics or anti-inflammatory drugs throughout the last three months prior to the study .
* status of pregnancy or lactation.
* allergy to local anesthetic.
* Prisoners .
* The vulnerable group ; mentally and physically disabled patients .
Acupuncture for Ischemic Post-stroke Depression

This is a multicentre, single Blind ,randomized controlled clinical trial in ischemic post-stroke depression patients.The participants will be allocated randomly in either of the two groups: verum acupuncture plus placebo medication group or sham acupuncture plus true medication group. On the hypothesis that acupuncture intervention could produce the same therapeutic effects as antidepressants. The investigators also hypothesized that acupuncture would be associated with minimal side effects.

Aim: To observe the curative effect of acupuncture in the treatment of Ischemic Post-Stroke Depression． Design: A multicentre,open-label randomized controlled trial will be performed in Tianjin and Beijing . Two hundred and eight participants with Ischemic Post-Stroke Depression patients were randomly divided into two groups which were both given basic treatment of stroke. The acupuncture group was given Tiaoshenkaiqiao acupuncture therapy and placebo，while the control group was treated with fluoxetine tablets and sham acupoint acupuncture treatment. Evaluated the clinical efficacy of the two groups with Hamilton Depression Scale(HAMD), Barthel Index (BI),Treatment Emergent Symptom Scale,(TESS ),Clinical Global Impression Scale(CGI) respectively before treatment, the second weekend of treatment ,the fourth weekend of treatment, the eighth weekend of treatment, the twelfth weekend of treatment. And observed the adverse reaction of the two groups.

Each participants will receive 36 sessions of acupuncture in 12 weeks, with a duration of 30 minutes in a session. After all the treatments were accomplished, there will be one follow-ups in the 24th week.

Eligibility Criteria:
Inclusion Criteria:

* in accordance with diagnosis of ischemic stroke in International Classification of Diseases-10 163, （ICD-10 163）;
* diagnosis of a major depressive episode according to the depression module of the Structured Clinical Interview for the Diagnostic and Statistical Manual of Mental Disorders-IV （DSM-IV）or Chinese Classification and Diagnostic Criteria of Mental Disorders-3(CCMD-3)
* age of a subject is between 40 and 80 years old, male or female;
* most recently experience an ischemic post-stroke depression and recent (\<6 months);
* conscious, examination cooperation, without aphasia and severe cognitive impairment;
* capacity to provide written consent for both research assessment and treatment.

Exclusion Criteria:

* participation in any clinical trial within the previous or taking antidepressant treatment 2 weeks prior to baseline;
* presence of severe cognitive dysfunction, indicated the Mini-mental State Examination (MMSE) score of \< 17
* presence of severe aphasia;
* had a history of psychiatric illness or depression
* impaired hepatic , renal function., hematological systems and so on;
* those who can not cooperate with treatment;
* pregnant women or women in lactation
* presence of another chronic disorder, including chronic alcoholism or durg abuse
Innovative Device for Pain Management by Millimeter Band Radiation : Electronic-Pain Killer.

In this study, in addition of conventional treatment, the efficacy of the medical device, Remedee One, in medical care of patients with peripheral osteoarthritis pain is evaluated.

Osteoarthritis affects 10 millions people in France (17% of the population). It's the second cause of disability and consultation after the cardiovascular diseases in France. For the moment, there is no curative treatment for osteoarthritis The main clinical sign of this disease is pain and care is based on the treatment of pain and on the improvement of functionnal disability. The proposed treatments are mainly based on the use of oral analgesics treatments .

At present, patients report to be insufficiently relieved. New strategies need to be developed. The hypothesis is that the use of an innovative medical device, Remedee One, can reduce the pain felt by patients, improve their quality of life and reduce the analgesics consumption.

The choice is oriented on the peripheral osteoarthritis and excludes spinal osteoarthritis because it's an osteoarthritis always asymptomatic and painless.

Eligibility Criteria:
Inclusion Criteria:

* Adult ≥ 50 years
* Patient followed in rhumatology consultation or at the center of the pain of the University Hospital of Grenoble or in liberal for peripheral osteoarthritis (ankle, knee, hip, shoulder, elbow, digital) clinically and radiologically confirmed according to the recommendations of the American College of Rheumatology.
* Patient with a pain score on a Visual Analog Scale (VAS) ≥ 4 on a numerical scale of 0 to 10 (average VAS intensity over the week prior to the inclusion visit),
* Patient with a stable analgesic treatment without introduction of a new therapeutic class within the last 3 months,
* Patient with a wrist size compatible with the size of the medical device
* Patient affiliated to social security or beneficiary of such a scheme.
* Having signed a consent to participate.

Exclusion Criteria:

* Patient with chronic inflammatory joint disease (chronic inflammatory rheumatism, rheumatoid arthritis, psoriatic rheumatism, spondyloarthritis, lupus),
* Patient who received an intra-articular corticosteroid injection within 3 months prior to inclusion,
* Patient with surgery scheduled within the next eight months,
* Patient presenting at both wrists a dermatological pathology such as oozing dermatosis, hyper sweating or an unhealed lesion,
* Patient having a piercing or implanted metallic material on both wrists,
* Patient with a tattoo on both wrists,
* Patient deprived of liberty by judicial or administrative decision
* Patient subject to legal protection or unable to express his consent (guardianship or curatorship)
* Patient in exclusion period of another interventional study
Vit D to Treat Asthma in Children: a Randomized, Double-blind, Placebo-controlled Trial

The purpose of this study is to determine whether vitamin D supplements can improve asthma control in children with moderate to severe asthma

The proposed interventional study will clarify the role of vitamin D in preventing asthma exacerbations and in achieving better chronic asthma control in children with moderate to severe asthma.

Eligibility Criteria:
Inclusion Criteria:

* Physician diagnosed asthmatics and they should fulfill at least two of the following three criteria:

  * A minimum of three clinic visits for acute asthma within 1 year
  * Two or more asthma-related hospital admissions within 1 year, or
  * Steroid dependency, as defined by either 6 months of oral or 1 year of inhaled corticosteroid use
* Age: 6-14 years old. The age group of 6 to 14 years old was chosen for two reasons:

  1. Diagnostic accuracy of asthma is better in this age group as non-specific wheezers less than 6 years of age could be excluded.
  2. Child should be able to use a peak flow meter and perform spirometry tests.
* A positive specific IgE or a positive skin prick test for at least one airborne allergen.

Exclusion Criteria:

* Children with mild intermittent and mild persistent asthma.
* Asthmatic children who are currently on immunotherapy or anti IgE.
* Asthmatic children with concomitant other medical problems.
* Children who are younger than 6 yrs or older than 14 yrs.
* Children with history of early life injury to airways like premature birth (\< 36 weeks) or home use of oxygen.
* Children with vitamin D deficiency. Since these children may be randomized to the control group, they will be excluded for ethical reasons.