cyrilzakka/clinical-trials huggingface dataset:
Evaluation of the Antalgic Effect of Puressentiel Joints and Muscles - Gel on Joint Pain of the Knee

This clinical trial aims to evaluate the antalgic effect of Puressentiel Joints and Muscles - Gel with 14 essential oils for 12 weeks on knee joint pain in 45 patients suffering from chronic pain related to arthritis of the knee. The evaluation of the puressentiel antalgic effect Joints and Muscles - Gel with 14 essential oils will be done by an algo-functional score of WOMAC based on items of pain, joint stiffness and locomotor function (main criterion), a visual analog scale EVA (graduated from 1 to 10) of the pain by self-assessment of the patient during the consultation and the number of daily analgesics and anti-inflammatory drugs (secondary criteria).

This clinical trial aims to evaluate the antalgic effect of Puressentiel Joints and Muscles - Gel with 14 essential oils for 12 weeks on knee joint pain in 45 patients suffering from chronic pain related to arthritis of the knee. The patients included in the study will be consultants from the Department of Physical Medicine, Rehabilitation and Sports Trauma at Foch Hospital in Suresnes and will have to present chronic pain related to arthritis of the knee either with or without antalgic and anti-inflammatory treatment. The evaluation of the puressentiel antalgic effect Joints and Muscles - Gel with 14 essential oils will be evaluated by an algo-functional score of WOMAC based on items of pain, joint stiffness and locomotor function (main criterion), a visual analog scale EVA (graduated from 1 to 10) of the pain by self-assessment of the patient during each visit and the number of daily antalgic and anti-inflammatory drugs (secondary criteria).

Eligibility Criteria:
Inclusion Criteria:

* Subject smust be able to understand the terms of the written informed consent and must agree to date and sign it before any study procedure is carried out,
* Patient having signed the informed consent
* Aged 45 to 90
* With chronic osteoarthritis of the knee
* Patient with or without analgesic and anti-inflammatory treatment

Exclusion Criteria:

* Patient at the stage of surgical osteoarthritis (grade 4 plus limitation of amplitude)
* Patient with a limited walking perimeter (\<100m) for any reason whatsoever
* Patient allergic to one of the components of the study product
* Patient not benefiting from social security
* Patient cannot be followed for the duration of the study
* Participation in another clinical trial within 30 days before V0
* Subjects who cannot understand or perform study procedures.
* Pregnant or breastfeeding women
* People with a history of convulsive or epileptic disorders
* People allergic to salicylates.
A Study to Investigate the Efficacy and Safety of Tezepelumab in Adult Participants With Moderate to Very Severe COPD (D5241C00007)

A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel Group, Phase 3 Study to Evaluate the Efficacy and Safety of Tezepelumab in Adults with Moderate to Very Severe Chronic Obstructive Pulmonary Disease (COPD)

This is a Phase 3, multicenter, randomized, double-blind, placebo-controlled, parallel group study to evaluate the safety and efficacy of tezepelumab in adults with moderate to very severe chronic obstructive pulmonary disease (COPD) receiving inhaled maintenance therapy and having had at least 2 moderate, or 1 severe, COPD exacerbations in the 12 months prior to Visit 1. Subjects will receive monthly subcutaneous injection of one of two different doses of tezepelumab, or placebo, with a maximum treatment duration of 76 weeks and a minimum of 52 weeks. The study also includes a off-treatment safety follow-up period of 12 weeks.

Eligibility Criteria:
Inclusion Criteria:

1. ≥40 to ≤80 years old
2. COPD diagnosis ≥1 year,
3. Post-BD FEV1 ≥ 20% and ≤ 70% PN, FEV1/FVC \<0.70 at screening
4. Triple (ICS+LABA+LAMA) or dual inhaled COPD therapy ≥3 consecutive months prior to V1
5. ≥2 moderate or ≥1 severe COPD exacerbations in the prior year; At least 1 of 2 moderate exacerbations must require the use of systemic corticosteroids
6. EOS ≥ 150 cells/μL during screening
7. CAT ≥15 at screening
8. Former or current smokers ≥10 pack-years

Exclusion Criteria:

1. Clin. important pulmonary disease or radiological findings suggestive of a respiratory disease other than COPD
2. Asthma, incl. pediatric, or ACOS
3. Any unstable disorder that can impact participants safety or study outcomes
4. Tuberculosis requiring treatment within 12 months prior V2
5. Malignancies current or past

   Concomitant therapies:
   * Macrolides (less than 6 months)
   * Systemic immuno-suppressive, -modulating medications
6. LTOT \>4.0 L/min or O2 saturation \<89% despite LTOT
Evaluation of a Personalized Physical Activity Coaching Program in Parkinson's Disease

There is growing interest for physical activity in Parkinson's disease in order to improve mobility and function of these patients. It seems from previous studies that difficulty, intensity and specificity of physical exercises are important parameters conditioning the effect of physical activity on cerebral plasticity and clinical improvement.

Thus, the aim of this study is to evaluate the benefits of a Personalized Physical Activity coaching program, including scheduled and frequent follow up associated with progressive readaptation of exercise intensity depending on individual performances (during 3 months), versus free practice of physical activity in Parkinson's disease.

Type of study: a randomized, single-blind, parallel-group, controlled clinical trial.

Number of centers: 1 (Clermont-Ferrand)

Patients

Patients eligible for inclusion will be randomized to one of the two groups:

* APA + : patients will beneficiate of Personalized Physical Activity coaching program during 3 months (1 hour, twice by week, during 3 months)
* APA- : patients will do free practice of physical activity during 3 months.

Study Performance Patients will be evaluated 3 times : at J0 (baseline, V1), 3 months after Personalized Physical Activity coaching program (J0+3M, V2), and 3 months after the end of the Personalized Physical Activity coaching program (J0+6M)

V1:

* Signature of an informed consent form.
* Demographic and clinical characteristics (sex, age, disease duration, treatments).

V1, V2, V3

* Neurological evaluation (Unified Parkinson Disease Rating Scale part III score)
* Evaluation of quality of life (Parkinson's Disease Questionnaire 39-item version (PDQ-39), participation to Daily life activities (Lawton and Brody Activities of Daily Living scale (IADL questionnaire25)
* Evaluation of performances for specific tests for balance (stabilometry), muscular strength (isometry)
* Evaluation of cardiorespiratory function (VO2pic et 6 min Walk Test)
* Evaluation of body composition (lean body mass/fat mass) with DEXA.
* Dropout rates at V2 and V3
* Evaluation of the activity with the eMOUVE application in a subgroup of patients.

Eligibility Criteria:
Inclusion Criteria:

* Clinical criteria for Parkinson's disease
* Men or women aged from 18 to 80 years old.
* Social security coverage.
* Ability to provide informed consent.

Exclusion Criteria:

* neurological disease other than Parkinson's disease
* severe depression (Beck Depression Inventory\>37) or psychiatric comorbidities (UPDRS I )
* significant cognitive impairment (MoCA\<24)
* orthopedic impairment with functional restriction
* contraindication to physical exercise
Use of Stress Inoculation Training in Medical Education

The purpose of this research study is to test the feasibility and effectiveness of SIT in teaching medical students to perform in high-fidelity simulation settings similar to those they may experience in their practice.

This is a study examining stress inoculation training and its potential role in medical education. The medical field exposes students and providers to various stressful situations each and every day. Various organizations including military organizations have introduced concepts of stress inoculation training (SIT) to help learners manage these situations to produce optimal performance.

Eligibility Criteria:
Inclusion Criteria:

* 1st and 2nd year medical students who are at least 18 years old

Exclusion Criteria:

* Prior airway management experience (including but not limited to former medics, respiratory technicians, CRNAs)
* Pregnant women
Comparison of Different Concentrations of Carbamide as Moisturizers in Ichthyosis Vulgaris

A randomized double blinded clinical trial will be conducted comparing the effect of two simple basic moisturizers only different in the concentration of carbamide (urea). The concentrations of carbamide will be tested are 0 and 7.5, respectively. The study will be conducted as a split-body-study and will contain two arms randomized to comparing 0 and 7.5 % carbamide, respectively. Approximately 20 patients with at least clinically verified Ichthyosis Vulgaris will be enrolled to each study arm. The effect of the moisturizers will be assessed by clinical examination (score), patients assesment of effect and measurement of transepidermal water loss (TEWL) and other skin parameters.


Eligibility Criteria:
Inclusion Criteria:

* Clinically diagnosed with Ichthyosis Vulgaris

Exclusion Criteria:

* All other forms of Ichthyosis
A Study of LY3113593 in Participants With Chronic Kidney Disease

This study is not intended to treat anemia of chronic kidney disease but to determine the safety of the study drug, LY3113593.

The study will also evaluate how much of the study drug gets into the blood stream, how long it takes the body to remove the study drug, and what effect the study drug has on the body.

The study consists of up to three parts. Participants may only enroll in one part. Participants will receive up to four injections of LY3113593 or placebo into a vein. The study will last up to about 26 weeks including screening and follow-up.


Eligibility Criteria:
Inclusion Criteria:

* Receiving hemodialysis regularly (at least 3 times per week) for at least 4 months
* Have a hemoglobin value (taken prior to dialysis, if taken on a dialysis day) greater than or equal to 9.5 grams per deciliter (g/dL) and less than or equal to 11.0 g/dL at screening
* Have been receiving erythropoiesis stimulating agent (ESA) injections for at least 4 weeks and are willing to stop the injections for approximately 8 weeks

Exclusion Criteria:

* Have another health condition that may put the participant at risk or that the study doctor feels would make the participant unsuitable for the study
* Currently taking part in another study
* Have recently (within 30 days) completed a study or have previously taken part in this study
Patients' Readings of Pre-operative Informed Consent Forms

Patient informed consent is a form which contains the patient's probable outcome of the procedure to be performed, and the probable risk and benefit of the patient's knowledge of the illness. On the form, completely honest and detailed information based on the facts are shared with the patient. It will be beneficial to both the physician and the patient to make a correct and complete consent procedure. The view, feelings and thoughts including the continuous and mutual understanding effort between the patient individual and the follow-up health team (physician, nurse, etc.) are essential in this sense.

The information that must be provided covers all of the following:

* The health status of the patient and the diagnosis,
* The type of treatment proposed,
* The chances of success and duration,
* The risk that the treatment modality carries for the patient's health,
* The use of medicines and possible side effects,
* The consequences of the illness if the hospital does not accept the recommended treatment,
* Alternative treatment options and risks. The informed consent is different from the signing of the patient indicating that he approves the procedure to be performed. The main purpose is to provide information to the patient and to understand this knowledge. For this reason, before the signing of the proclamation, it is necessary to ensure that the patient is informed in accordance with his or her own cultural and educational level. In addition, the patient must be audited that he/she understands the given information.

The purpose of this study is to investigate whether the informed consent forms given to the patient after informing by the physician were read as the first reflex before signing.


Eligibility Criteria:
Inclusion Criteria:

* Being scheduled for surgery.
* Accept being part of the study and share information such as inform consent form readings and demographics.

Exclusion Criteria:

* Not to accept being part of the study and share information such as inform consent form readings and demographics.
Pediatric Solid Tumor Metabolism [A Prospective Study Exploring Metabolism of Solid Tumors in Pediatrics]

To explore metabolic phenotypes of children with extra-cranial solid tumors and compare these with their histopathological and genetic alterations to discover potential novel biomarkers and therapeutic targets to improve outcomes in children with high risk disease.

The principal objective of this study is the metabolic characterization of pediatric solid tumors, with a particular focus on neuroblastoma (NBL) and fusion positive sarcoma (FPS), which will allow the detection of tumor specific metabolic alterations that can be exploited with the aim of developing novel therapeutic strategies and biomarkers.

Cellular metabolism studies provide insight, in a complementary way to genomics, into processes acting downstream from oncogenes and oncogenic fusion proteins, and such insight may point toward previously unrecognized therapeutic targets or onco-metabolites that are traceable as robust biomarkers for response. The investigator's new approach to use an in-vivo comprehensive analysis of metabolic reprograming in FPS/NBL has never been performed in childhood FPS/NBL and will complement genomics studies for these cancers. For this study, the investigators plan to obtain tumor samples at time of surgical biopsy/resection and study their metabolic signatures.

Eligibility Criteria:
Inclusion Criteria:

* Suspected malignancy
* Age ≤ 26 years and being cared for at Children's Medical Center
* Ability to undergo standard of care diagnostic procedure, including biopsy or resection of the tumor, in the OR or IR at CMC

Exclusion Criteria:

* Poorly controlled diabetes
* Any other medical condition that prevents administration of glucose
Exercise and Radiotherapy, a Good Combination?

Every year, almost 3000 Norwegian women are diagnosed with breast cancer. Various symptoms of short-and long-term side effects may be experienced, such as physical deterioration, reduced quality of life and fatigue. At St.Olavs Hospital, Trondheim University Hospital, all out-patients undergoing post operative radiotherapy are currently offered participation in group exercise training sessions. The main purpose of this study is to evaluate these out-patient group exercise sessions.


Eligibility Criteria:
Inclusion Criteria:

* Surgery for breast cancer.
* Completed chemotherapy treatment.
* Radiotherapy is scheduled.

Exclusion Criteria:

* metastatic disease
* pregnancy
* drug abuse
Vaccine Therapy For Patients Being Considered For Organ Transplant Who Are at Risk For PTLD

RATIONALE: Vaccines made from a person's white blood cells may help the body build an effective immune response.

PURPOSE: This phase I trial is studying the side effects of vaccine therapy in treating patients who are being considered for solid organ transplant who are at risk for post-transplant lymphoproliferative disorder.

OBJECTIVES:

Primary

* Determine the efficacy of photochemically-treated autologous Epstein-Barr virus (EBV)-transformed B-lymphoblastoid cell vaccine in generating an EBV-specific T-cell and antibody response in EBV-negative patients or in boosting the response in EBV-positive patients who are being considered for a solid organ transplant and are at high risk for post-transplant lymphoproliferative disorder.
* Determine adverse events associated with this vaccine in these patients.
* Determine the ability of the vaccine to protect from EBV primary infection in EBV-seronegative patients during the time course of the study.

OUTLINE: This is a nonrandomized, pilot study. Patients are stratified according to Epstein-Barr virus (EBV) status (seropositive vs seronegative).

Patients receive photochemically-treated autologous EBV-transformed B-lymphoblastoid cell vaccine intradermally once in weeks 0 and 4.

After completion of study treatment, patients are followed periodically for up to 5 years.

PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Being considered for a solid organ transplant
* At high risk for post-transplant lymphoproliferative disorder

PATIENT CHARACTERISTICS:

* Body weight ≥ 25 kg
* Karnofsky performance status 50-100% OR
* Lansky performance status 50-100%
* Not pregnant
* Negative pregnancy test
* Fertile patients must use contraception during and for 2 months after completion of study treatment
* Hemoglobin ≥ 8 g/dL (erythropoietin allowed)
* No history of autoimmune disease, including any of the following:

  * Systemic lupus erythematosus
  * Sarcoidosis
  * Rheumatoid arthritis
  * Glomerulonephritis
  * Vasculitis
* No primary immunodeficiency
* No HIV positivity

PRIOR CONCURRENT THERAPY:

* No corticosteroids for 1 month before and for 1 month after the first study vaccination, except for the following:

  * Physiologic steroid dosing (≤ 20 mg/day of prednisone or steroid equivalent) for adrenal insufficiency
  * Inhaled steroids
Study of Nerve Reconstruction Using AVANCE in Subjects Who Undergo Robotic Assisted Prostatectomy for Treatment of Prostate Cancer

The purpose of this study is to determine if it is technically feasable to repair nerves that are injured as part of a planned surgical removal of the prostate and the surrounding tissue in subjects with prostate cancer. The study will also examine the long term outcomes on erectile function, continence and overall quality of life in the enrolled subjects.


Eligibility Criteria:
Inclusion Criteria:

* ≥ 18 years of age, but ≤70 years of age;
* IIEF EF Domain\*1 score ≥ 22;
* be able to effectively communicate with study personnel;
* be considered by the physician to be available for subsequent visits;
* be willing to comply with all aspects of the treatment and evaluation schedule over a 24 month duration;
* sign and date an IRB-approved written informed consent prior to initiation of any study procedures, including screening procedures; and
* require radical prostatectomy.

Exclusion Criteria:

* prior surgery in the last 6 months which could affect sexual function;
* history of Peyronie's disease;
* significant neurological disorder (i.e. multiple sclerosis, peripheral neuropathy);
* treatment for major psychiatric disorders;
* history of penile implant or prosthesis;
* history of diabetic neuropathy;
* life expectancy of less than two years;
* concurrently involved in another investigational study;
* uncontrolled hypertension with systolic BP \>200mmHg or diastolic BP \>115mmHg is present at screening;
* currently receiving or planned treatment with chemotherapy or radiation therapy;
* diagnosis of bony metastasis;
* known allergy or severe intolerance to PDE-5 inhibitors; or
* cardiac pacing equipment or other electro-mechanical devices which preclude the use of CaverMap™ neurostimulator.
Evaluating the Well-being Among Dental Students With Warwick-Edinburg Mental Well-Being Scale

The present study was conducted to measure the mental well-being amongst dental students by using Warwick-Edinburg Mental Well-being Scale (WEMWBS) and investigate factors affecting well-being among dental students.

The survey schedule was planned to be independent of the students' assessment period and the questionnaire was administered to the students when they were attending a lecture together. After the lecture, a researcher explained to the students the purpose of this survey and assured them of confidentiality. Participation in this study was also voluntary, and all participants remained anonymous. The questionnaire was given to all participants after explaining the purpose of the study. The questionnaire included demographic details (age, gender, year of study), social background (parents' education levels, family income, first choice for admission, living accommodation) and lifestyle behaviors (smoking status, presence of regular sport activity and hobby). In addition, Warwick-Edinburg Mental Well-Being Scale was applied to the participants of this study.

Eligibility Criteria:
Inclusion Criteria:

to be officially registered in the faculty of dentistry, Baskent University

Exclusion Criteria:

unwilling to participate
Study of Gemcitabine With TheraSphere® (Yttrium-90)in Patients With Hepatic Tumors of Pancreatobiliary Origin

Therasphere is a form of treatment that has been designed to selectively deliver radiation to the cancer within the patient's liver. This form of treatment has been used in a number of clinical trials and has been approved for use in the treatment of liver cancer.

The investigators want to test the safety of using Gemcitabine (a chemotherapy drug) with TheraSphere (radioactive beads that are injected directly into the blood vessel supplying the tumor in the liver) in patients with advanced pancreatobiliary tumors such as pancreatic cancer or cholangiocarcinoma (bile duct tumors) involving the liver.

Patients with liver predominant cholangiocarcinoma or pancreatic cancer will be considered for the trial. The patients wre being treated in groups of thre patients. Each three patients receive a pre-specified dose of gemcitabine with full dose radioembolization using theraspheres. If no significant side effects are observed then three additional three patients will be treated with a higher dose of gemcitabine. The purpose to identify the highest dose of gemcitabine that can be safely combined with theraspheres.

Eligibility Criteria:
Inclusion Criteria:

1. Histologic or cytologic diagnosis of pancreatic cancer or cholangiocarcinoma
2. Liver predominant disease defined as

   - Cholangiocarcinoma: liver disease should be unresectable

   - Limited extra hepatic metastasis defined as: i. Lung metastasis: 6 or less nodules with no nodule greater than 1.5 cm.

   ii. Abdominal lymph nodes iii. Pancreatic primary as long as the size is less than 4 cm in size iv. Bone metastasis
3. No prior systemic therapy for advanced stage disease
4. Measurable target tumors using standard imaging techniques
5. Lung shunting less than 20%
6. ECOG performance status 0-1 (See Appendix )
7. Age ≥ 18 years
8. No other investigational agents while on protocol
9. Signed informed consent

Exclusion Criteria:

1. Inadequate hepatic function: AST/ALT \> five times upper limit of normal, Bilirubin \>2.0 mg/dl or history of hepatic encephalopathy
2. Inadequate renal function Creatinine \> 2.0 mg/dL
3. Inadequate bone marrow function: platelets \< 100,000/mL or absolute neutrophil count \<1500/mL
4. Contraindication to angiography
5. Prior external beam radiotherapy to the upper abdomen
6. Clinical evidence of peritoneal metastasis or ascites
7. Patients with extensive tumor replacement in the liver defined as \>50% of liver involved with tumor
8. Any serious ongoing extra-hepatic disease such as infections.