cyrilzakka/clinical-trials huggingface dataset:
Experience of Hospital Students in the Odontology Department

During their studies, the dental students of Brest (France) learn their future profession by working in the Dental University Hospital, from the fourth academic year. This clinical activity is considered as both a source of satisfaction and stress by most of the students. The main objective of this study is to investigate the experience of Brest dental students through a qualitative methodology, with individual interviews, followed by an analysis by grounded theory (Paillé, 1994).

During their studies, the dental students of Brest (France) learn their future profession by working in the Dental University Hospital, from the fourth academic year. This clinical activity is considered as a source of satisfaction by most of the students. They are also reassured because they know that they will easily find an employment at the end of their studies. However, the clinical activity can also create a stress among the students, which varies with their progress in their studies (Polychronopoulou et Divaris, 2009). Other sources of stress could also be identified. This multifactorial stress can influence their well-being, their practices and their relationships with patients. The stress and satisfactions of the dental students have mainly been studied by some questionnaires (Inquimbert et al., 2017). The main objective of this study is to investigate the experience of Brest dental students through a qualitative methodology, with individual interviews, followed by an analysis by grounded theory (Paillé, 1994). This type of research can enable us to keep a broad approach of students' experience and to stay faithful to it.

Eligibility Criteria:
Inclusion Criteria:

* volunteer students of Brest Dental University Hospital, having given his/her consent
* adult students of Brest Dental University Hospital, in fourth, fifth and sixth academic year

Exclusion Criteria:

* students in work-stoppage
* students in Erasmus program
* non-volunteer students or students refusing to give his/her consent
The Factors Cause Vasospasm After Aneurysmal Subarachnoid Hemorrhage

Extensive research has shown that the big event that leads to the initiation of vasospasm is the release of oxyhemoglobin (blood breakdown product).Depletion of NO synthase (19,20,21) was also noted after SAH.CSF is produced from choroid plexus in the ventricle. If the SAH is too dense, the blood in the subarachnoid space will not easy to be washed out.

Cerebral vasospasm remains a significant source of morbidity and mortality in patients with subarachnoid hemorrhage (SAH) after an aneurysmal rupture. Despite being a significant source of morbidity and mortality, death and disability from vasospasm have declined from approximately 35% in the early 1970's, to between 15% and 20% in the 1980's to \<10% in the 1990's(1,2,3,4).Extensive research has shown that the big event that leads to the initiation of vasospasm is the release of oxyhemoglobin (blood breakdown product)(1,12,13). This mechanism appears to be a multifactorial process that involves the generation of free radicals, lipid peroxidation and activation of protein kinase C as well as phospholipase C and A2 with resultant accumulation of diacylglycerol and the release of endothelin-1(14,15,16,17,18). On the other hand, depletion of NO synthase (19,20,21) was also noted after SAH. Previous reports showed that shunting of CSF through a lumbar drain after an SAH markedly reduces the risk of clinically evident vasospasm and its sequelae, shortens hospital stay, and improves outcome. Its beneficial effects are probably mediated through the removal of spasmogens that exist in the CSF(22). In our preliminary data, we have demonstrated a case with severe vasospasm, CSF was collected both from EVD and lumbar drain. The ADMA level and amount of Nitrate was well correlate with vasospasm and the level was much higher in lumbar drain then EVD. So, we will compared the CSF from EVD and lumbar puncture to see which factor is correlate with vasospasm.

Eligibility Criteria:
Inclusion Criteria:

* Aneurysmal rupture with SAH

Exclusion Criteria:

* Bleeding tendency,
* Large ICH with impending herniation
Investigation of the Effectiveness of Dynamic Neuromuscular Stabilization Exercises After Lumbar Disc Herniation Surgery

The aim of the study is to investigate the effects of dynamic neuromuscular stabilization exercises on pain, functionality and fear in individuals who have undergone lumbar disc herniation surgery.

The research was planned as a randomized controlled trial, which is a quantitative study. Participants will be divided into 2 groups as control and exercise groups by simple randomization method. The individuals in the control group of the study will not be given any exercise program after surgery. A home exercise program created with Dynamic Neuromuscular Stabilization exercises after surgery will be applied to the individuals in the intervention group. Data collection will be carried out through an online survey. The scales and forms to be used before and after the treatment are respectively: 1. Oswestry Low Back Pain Disability Questionnaire 2. International Physical Activity Questionnaire (Short Form) 3. Questionnaire for Fear of Daily Living Activities The questionnaires will be uploaded to the Google Forms database and the participants will be accessed via e-mail or mobile phone applications. . They will be asked to fill out the questionnaires before starting the post-surgical exercise program and the exercise program will be explained practically before discharge. The exercises will be planned 3 times a week and for 8 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Be between 30 and 50 years old.
* Having undergone lumbar disc hernia surgery.
* Having access to a computer/tablet/phone and internet.

Exclusion Criteria:

* Having cognitive, mental or psychological problems.
* Having a visual or hearing impairment.
* Having a physical condition that causes significant loss of function
Study of the Response and Cardiorespiratory Endurance in Early RA Patients Treated With Tocilizumab or Methotrexate

To measure the CRE by a work capacity index obtained in a submaximal testing (W65%/kg) in early RA patients treated with tocilizumab compared to Methotrexate alone.

The secondary endpoints : analyze the clinical efficacy of Tocilizumab in this population and correlate the CRE response with other marker (CRP, Hb, DAS, HAQ) and evaluate the safety profile of Tocilizumab.

Rheumatoid arthritis (RA) is the most prevalent (about 1%) inflammatory rheumatic disorder.

Interleukin-6 (IL-6) has emerged as a potential therapeutic target in RA. This is based on the greater understanding of the role this cytokine can play in various aspects of the pathogenesis of RA. It has been shown that IL-6 is responsible for various clinical symptoms, including,fatigue, anemia, anorexia, fever, as well as the production of autoantibodies and increase in the erythrocyte sedimentation rate, all of which develop in patients with RA. Tocilizumab, as monotherapy and in combination with methotrexate, has been shown to be effective for RA patients with insufficient response to methotrexate or other disease-modifying antirheumatic drugs. These observations about the effects of tocilizumab were extended to patients refractory to tumor necrosis factor inhibitors. Tocilizumab also slows down the progression of structural joint damage. Furthermore, a 5-year long-term safety and efficacy has been shown. The place of Tocilizumab therapy in early RA is still unknown.

Cardiorespiratory endurance (CRE), the most fundamental component of physical fitness can be severely impaired in patients with rheumatoid arthritis (RA). It has been shown that intensive and early treatment of RA can induce sustained clinical remission, improve general health and physical fitness and might therefore have an impact on the quality of life of RA patient. This study was planned to measure the CRE by a work capacity index obtained in a submaximal testing (W65%/kg) in early RA patients treated with tocilizumab compared to Methotrexate alone.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of RA (according to American College of Rheumatology ACR criteria)
* Disease duration \< 2 years.
* Age between 18 and 70 years old.
* Active RA defined by a disease activity score 28 DAS28-CRP score \> 3.2 with a swollen joint count ≥ 4
* MTX naive
* Stable therapy with corticosteroids or nonsteroidal anti-inflammatory drug NSAIDs
* Presence of knee arthralgia or synovitis (addendum protocol with synovial biopsy).

Exclusion Criteria:

Previous MTX treatment. Exclusion for severe physical handicap to perform CRE. Exclusion for general safety (history of severe allergic reaction, sepsis, malignancy within 5 years, pregnancy, severe heart failure) Concurrent treatment with other DMARDs than MTX or any anti-TNF and biological therapies.
Efficacy and Safety of Ketoprofen Topical Patch 20% in the Treatment of Pain Associated With Ankle Sprain or Strain

The purpose of this study is to evaluate the effect of a ketoprofen topical patch on the pain associated with ankle sprain or strain.

This randomized, double-blind, placebo-controlled, parallel group study will be conducted in patients with Grade 1 or Grade 2 ankle sprains or strains. Eligible patients will be randomized (in a 1:1 ratio) to receive double-blind treatment with either the KTP or a matching placebo patch to be applied once daily for 14 days. Patients will return to the clinic for assessments on Day 3, Day 7 and Day 14; a follow-up assessment will be conducted by telephone on Day 28. At each visit through Day 14, patients will rate their average pain intensity during daily activities and while at rest using an 11-point scale, and will rate their functional disability. Patients will also complete an electronic diary in which pain intensity and pain relief ratings will be recorded three times daily. Ratings of the quality of sleep will be recorded in the diary each morning, and the use of study treatment and rescue medication will be recorded in the diary each day. Ibuprofen will be provided as rescue medication

Eligibility Criteria:
Inclusion Criteria:

* Males or females 18 years of age or older
* Diagnosis of Grade I or Grade II ankle sprain or strain
* Meet pain entry criteria
* Willing to discontinue use of any pain medication not provided as part of the study

Exclusion Criteria:

* Have a Grade 3 sprain or Grade 3 strain, bilateral sprain or strain, or concomitant fracture or wound at the site of the sprain or strain.
* Have received corticosteroids in the 30 days preceding screening
* Have a history or physical examination finding that is incompatible with safe participation in the study
* Have a history or physical examination finding that is incompatible with study product use
* Are taking medications or other substances contraindicated due to the nature of the study medication or the potential for drug interactions.
* Are taking medications that may significantly affect renal function
Natural Course of Adhesive Capsulitis of Hip

The purpose of this prospective study is to see the natural course of adhesive capsulitis of hip. The study is based on the hypothesis that the natural course of adhesive capsulitis of hip is similar to that of adhesive capsulitis of shoulder. This study is also based on a hypothesis that hip joint capsule stretching exercise will result in pain relief, recovery of hip range of motion in months.


Eligibility Criteria:
Inclusion Criteria:

* Painful hip with Limited range of motion (especially external rotation and abduction)

Exclusion Criteria:

* Acute trauma history
* hematologic abnormality (Rheumatologic disease, Autoimmune disease)
* Radiologic abnormality (joint degenerative change, calcification, loosebody, evidence of Femoroacetabular impingement, osteonecrosis of femoral head, etc)
* MRI: Extra-articular pathology
Effect of Energy Density Over 5 Days in Preschool Children

In this study, the investigators will vary the energy density of foods served during three 5-day periods. There will be a baseline condition, and then a condition where the energy density of food is lower and a condition where the energy density of food is higher. The primary aim is to determine the effect of varying the energy density of foods served over 5 days on energy intake in preschool children. It is hypothesized that mean daily energy intake will be greater when children are served higher energy dense foods over 5 days than when served lower energy dense foods over the same period. Additionally, it is hypothesized that daily energy intake in the conditions with higher and lower energy densities will begin to converge across the 5-day period.


Eligibility Criteria:
Inclusion Criteria:

* Attending one of the designated daycare centers

Exclusion Criteria:

* Food Allergies
* Food restrictions
* Health Issues that Preclude Participation
* Not available for duration of the study
Insulin Deprivation on Brain Structure and Function in Humans With Type 1 Diabetes

What are the effects of transient insulin deprivation on brain structure, blood flow, mitochondrial function, and cognitive function in T1DM patients?

What are the effects of transient insulin deprivation on circulating exosomes and metabolites in T1DM patients?

Diabetes is associated with impaired cognition, abnormal brain development in children, and dementia in older adults, however the underlying mechanisms remain unclear. Little is known about the brain-specific effects of acute insulin deficiency. Our recent studies in diabetic mice show an overall down regulation of brain mitochondrial ATP production and up regulation of several key mitochondrial proteins, indicating that insulin withdrawal has a profound effect on brain mitochondria as well as proteins implicated in neurodegeneration. Hyperglycemia is known to alter cognitive function, but it is unclear if insulin deprivation independently alters cognitive function and has not been assessed in humans.

In order to investigate the effects of insulin deprivation on the human brain, we propose a study involving temporary insulin deprivation in adolescents and adults with type 1 diabetes (T1DM). We will perform brain MRI, phosphorus31 spectroscopy, cognitive testing, circulating blood exosome measurements, and proteomics from muscle biopsy; comparing these measures during insulin treatment and deprivation between diabetic patients and age-, sex-, BMI-matched controls.

Specific aim 1: Determine whether transient insulin deprivation in T1DM adults and adolescents alters brain structure, functions and blood flow as assessed by structural/functional MRI.

Specific aim 2: Determine whether transient insulin deprivation in T1DM adults and adolescents alters cognitive function.

Specific aim 3: Determine whether transient insulin deprivation in T1DM adults and adolescents alters the circulating blood exosome contents and metabolome that can potentially impact brain functions.

Specific aim 4: Determine whether transient insulin deprivation in T1DM adults alters the skeletal muscle proteome homeostasis especially those involved in fission and fusion

Eligibility Criteria:
Inclusion criteria:

* Male and females age 14-17 years, females must be post-menarcheal
* Age 18-45 years
* Able to provide written consent
* Parents able to provide written consent
* T1DM treated with CSII or MDI (not degludec)

Exclusion criteria:

* BMI \< 20 or \> 30 kg/m2
* BMI z-score \<5th or \>95th percentile
* Celiac disease
* Pregnancy
* Smoking
* Reported history of illicit substance use
* History of active cardiovascular, cerebrovascular, or peripheral vascular disease
* Active renal disease evidenced by estimated GFR \< 50 mL/min/1.73 m2
* History of traumatic brain injury
* Dementia or any other neurologic disease
* Psychiatric disease\\
* Any learning disability
* Hemoglobin A1c \> 8.5%
* Hemoglobin A1c \> 9%
* T2DM, or impaired fasting glucose
Immunotherapy in Combination With Chemoradiation in Patients With Advanced Solid Tumors

This is an open-label, multicenter, phase I study to evaluate the safety and tolerability of durvalumab ± tremelimumab in combination with chemoradiation in patients with advanced solid tumors

This study will initially treat up to approximately 300 patients with advanced solid tumors at approximately 30 sites, worldwide. The study will be composed of a dose-limiting toxicity (DLT) assessment phase (Part A) and an expansion phase (Part B).

Eligibility Criteria:
Inclusion criteria:

* World Health Organization (WHO)/ECOG performance status of 0 or 1
* Body weight \>30 kg at enrollment and treatment assignment
* At least 1 measurable lesion, not previously irradiated
* No prior exposure to immune-mediated therapy (including therapeutic anticancer vaccines)
* For patients with oropharyngeal HNSCC HPV status has to be known

Exclusion criteria:

* Patients with simultaneous primary malignancies or bilateral tumors
* Active or prior documented autoimmune or inflammatory disorders
* Brain metastases or spinal cord compression
* Active infection including tuberculosis, hepatitis B, hepatitis C, or human immunodeficiency virus (HIV; positive HIV 1/2 antibodies)
* Has a paraneoplastic syndrome (PNS) of autoimmune nature
* HNSCC cohort: Head and neck cancer that does not include unresectable, locally advanced cancer of oral cavity, larynx, oropharynx or hypopharynx. HNSCC of unknown primary are also excluded
* NSCLC and SCLC cohort: Mixed SCLC and NSCLC histology
* SCLC cohort: Extensive-stage SCLC
CAR-T Therapy for Central Nervous System B-cell Acute Lymphocytic Leukemia

This study will evaluates the safety and efficacy of Chimeric antigen receptor T cells (CAR-T) in treating central nervous system B-cell acute lymphocytic leukemia.

CNS leukemia is defined as unequivocal evidence of leukemic blasts in the cerebrospinal fluid by cytology or flow cytometry; cranial palsies or a nonhemorrhagic mass seen in cranial computed tomography or magnetic resonance imaging because of infiltration by leukemia cells

Eligibility Criteria:
Inclusion Criteria:

1. Patients with CD19 positive central nervous system B-cell acute lymphocytic leukemia
2. ALT/ AST 《 3x normal
3. Creatinine 《 3x normal
4. Age:10-60.
5. Signed informed consent

Exclusion Criteria:

1. Active hepatitis B , hepatitis C or HIV infection
2. Uncontrolled active infection
3. Pregnancy or breast-feeding women
4. Survival less than four weeks
Cetuximab and Cisplatin in the Treatment of "Triple Negative" (Estrogen Receptor [ER] Negative, Progesterone Receptor [PgR] Negative, and Human Epidermal Growth Factor Receptor 2 [HER2] Negative) Metastatic Breast Cancer

The primary objective of this study is to determine whether overall response to cetuximab combined with cisplatin is better than overall response to cisplatin alone together with showing that the overall response for cetuximab and cisplatin was above a pre-specified threshold of 0.2 in the treatment of "triple negative" metastatic breast cancer.

The secondary objective of this study is to compare the differences between the two treatment groups using the following criteria : Progression-Free Survival (PFS) Time, Overall Survival (OS), Time to Response (TTR) and Safety.


Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed diagnosis of metastatic breast cancer (Stage IV)
* Estrogen Receptor \[ER\] negative, PgR negative and HER2 less than 3+ expression by immunohistochemistry (IHC)
* No more than 1 prior chemotherapy received for treating this metastatic breast cancer
* No more than 1 prior anthracycline and/or taxane regimen (either adjuvant or metastatic setting)
* Other protocol-defined inclusion criteria may apply

Exclusion Criteria:

* Prior platinum agent
* Prior mitomycin
* Known history of brain metastases
* Other protocol-defined exclusion criteria may apply
TACE+RFA Versus Re-resection for Recurrent Small Hepatocellular Carcinoma

Hepatocellular carcinoma (HCC) is the fifth most common cancer in the world. Partial hepatectomy is still considered as the conventional therapy for HCC. Intrahepatic recurrence of HCC after partial hepatectomy is common and was reported to be more than 77% within 5 years after surgery. Repeat hepatectomy is an effective treatment for intrahepatic HCC recurrence, with a 5-year survival rate of 19.4-56%. This is comparable to the survival after initial hepatectomy for HCC. Unfortunately, repeat hepatectomy could be carried out only in a small proportion of patients with HCC recurrence (10.4-31%), either because of the poor functional liver reserve or because of widespread intrahepatic recurrence. In the past two decades, percutaneous radiofrequency ablation (PRFA) has emerged as a new treatment modality and has attracted great interest because of its effectiveness and safety for small HCC (≤ 5.0 cm). Studies using PRFA to treat recurrent HCC after partial hepatectomy reported a 3-year survival rate of 62-68%, which is comparable to those achieved by surgery. PRFA is particularly suitable to treat recurrent HCC after partial hepatectomy because these tumors are usually detected when they are small and PRFA causes the least deterioration of liver function in the patients. Our previous retrospective study demonstrated that RFA was comparable to re-resection for recurrent HCC, and our recent RCT showed that RFA combined with TACE is superior to RFA for HCC ≤7.0cm. So our hypothesis is that RFA combined with TACE is superior to re-resection for recurrent small HCC. The aim of this retrospective study is to compare the outcome of reresection with TACE+RFA for small recurrent HCC after partial hepatectomy.


Eligibility Criteria:
Inclusion Criteria:

1. age 18 - 75 years;
2. recurrence of HCC 12 months after initial hepatectomy;
3. no other treatment received except for the initial hepatectomy;
4. Single tumor≤5cm in diameter; or 2-3 lesions each ≤ 3.0 cm
5. lesions visible on ultrasound and with an acceptable and safe path between the lesion and the skin as shown on ultrasound;
6. no severe coagulation disorders (prothrombin activity \< 40% or a platelet count of \< 40,000 / mm3;
7. Eastern Co-operative Oncology Group performance(ECOG) status 0 -1

Exclusion Criteria:

1. the presence of vascular invasion or extrahepatic spread on imaging;
2. a Child-Pugh class C liver cirrhosis or evidence of hepatic decompensation including ascites, severe coagulation disorders (prothrombin activity \< 40% or a platelet count of \< 40,000 / mm3), esophageal or gastric variceal bleeding or hepatic encephalopathy;
3. an American Society of Anesthesiologists (ASA) score ≥ 3 -
Effects of Tribulus Terrestris on Sexual Function in Post-menopausal Women

Objective: To study the effects of Tribulus terrestris on sexuality in postmenopausal women.

Sexuality is an integral part of every personality, influence thoughts, feelings, actions, integrations, and therefore the physical and mental health. It is estimated that 43% of women have at least one complaint of sexual problem. Disorders of desire and arousal are among the most common problems found in gynecologic practice. Medicinal plants have been used for therapeutic purposes for thousands of years, and aphrodisiac properties described in several plants. Tribulus terrestris is a plant indigenous to India, recommended in the treatment of infertility, low libido and impotence, and its main active ingredient protodioscin (PTN).

Eligibility Criteria:
Inclusion Criteria:

* Women past menopause, with full autonomy, at least one year of amenorrhea and FSH\> 30 mIU / mL.
* Sexually active
* Partner is stable and without sexual difficulties
* Carrier sexual abuse (desire, arousal, orgasm and dyspareunia)

Exclusion Criteria:

* Women on hormone therapy within the preceding 12 months
* Women without sexual activity
* With diabetes mellitus
* Patients with cognitive impairment
* Patients with hormone-dependent tumor
* History of psychiatric illness
* Patients with liver disease
* Patients with kidney disease
* Users of drugs with proven to decrease sexual desire
* Cardivascular disease, renal disease.