cyrilzakka/clinical-trials huggingface dataset:
Biomedical Innovation for Facial Bone Reconstruction in Oncology: BIOFACE PASS a Medico-economic Study Describing the Standard Pathway of Patients Treated by Free Bone Flap

The purpose of this study is to describe the standard of care pathway of patients treated by free bone flap for facial mandibullar or maxillar reconstruction after surgery for head and neck cancers.

Curative management of head and neck cancers frequently requires an interrupting mandibulectomy or maxillectomy. Surgery may involve resection of anatomical structures such as jaw or maxilla. The use of free vascularized fibula or scapula flap is the "gold standard" for mandibular and maxillary reconstruction but remains suboptimal as resulting in difficulty in speaking, swallowing, and disfigurement.

The BIOFACE project, funded by "Appel à Projet -Recherche Hospitalo-Universitaire en santé (RHU)" number 6 France 2023, aims to develop a new biomaterials based device to reconstruct these structure after surgery. In addition to the clinical benefits, this project aims to demonstrate the medico-economic benefits of the BIOFACE solution. Therefore, the Bioface PASS study has been designed to describe standard of care pathways of patients treated by free bone flap for facial reconstruction after surgery for head and neck cancer. Direct medical and non-medical costs, and daily allowance 12 months after the end of treatment, and quality of life will be recorded at the inclusion, 3 and 12 months.

From the hospital perspectives, production costs will be recorded using the micro-costing approach.

Eligibility Criteria:
Inclusion Criteria:

* Patient with oral cavity cancer or maxillary and/or oropharynx cancer
* Eligible for treatment by surgery requiring a mandibulectomy or segmental maxillectomy and having a free bone flap for facial reconstruction.
* Patient whose disease is classified Stage cT4a, N0 to N3, M0
* Treatment with a feasible curative aim (no contraindication to optimal treatment such as surgery or chemotherapy at a curative dose)
* Age greater than or equal to 18 years
* Patient affiliated to a Social Security scheme in France
* Patient having given written informed consent

Non-inclusion Criteria:

* Patient having any situation considered by the doctor as a reason for non-inclusion such as stenosis of the leg tripod not allowing reconstruction by fibula, one or more comorbidity(s) not allowing reconstruction by free bone flap or making this reconstruction too much risk
* Patient having had previous radiotherapy
* Patient with severe coagulation disorders
* Patients deprived of liberty or under legal protection regime (curatorship and guardianship, safeguard of justice)
Short-Term Effects of Medicinal Cannabis Therapy on Spasticity in Multiple Sclerosis

The purpose of this study is to determine whether or not smoked marijuana improves spasticity in patients with multiple sclerosis.

Studies of cannabinoids for spasticity in MS have had mixed results but clinical studies have been small, generally not properly controlled, with results controversial, and difficult to interpret. Recently, investigators in the UK and US tested the ability of cannabinoids to control spasticity and tremor symptoms of the MS-like disease, experimental allergic encephalomyelitis, in mice (Baker et al, 2000). The authors found that four different cannabinoids quantitatively ameliorated both tremor and spasticity in diseased mice; thus providing rationale for patients' reports of the therapeutic effects of cannabis in the control of their MS symptoms.

The present study will be a randomized, placebo-controlled, crossover design of 30 patients who will be assessed before and after treatment for 3 consecutive days (Phase I), undergo washout-out for a total of 11 days, and then cross over to either the placebo or active treatment phase (Phase II), depending on what they received during Phase I. At each study visit, patients will utilize a controlled puff procedure to help ensure stable intake (Levin et al, 1989).

Comparisons: A single dose of 4% THC marijuana cigarette each day for 3 days will be compared to a placebo administered under the same dosing conditions for the relief of spasticity, drug tolerability, and changes in global functioning and quality of life indices.

Eligibility Criteria:
Inclusion Criteria:

* Clinically definite or probable, laboratory-supported MS
* Complaints of spasticity and at least moderate increase in tone as evidenced by a score of \>= 2 on the Modified Ashworth Scale at either the elbow, hip, or knee
* If on disease-modifying therapy ("ABC"), have been on a stable dose for at least six months
* Fluent in English
* If not cannabis-naive, must refrain from smoking cannabis for two weeks prior to screening (confirmed by urinalysis)
* If on either lioresal (Baclofen) or tizanadine (Zanaflex), have been on a stable dose for at least three months
* \>=18 years of age

Exclusion Criteria:

* Axis I psychiatric disorder especially depression or significant neurological disease other than MS as determined by the PI
* Recent history of active substance abuse defined as daily use for at least 14 days within the past month
* Drug use restrictions, eg, subjects on probation or parole, employment involving high risk to themselves and/or the public (airline pilot, bus driver, etc.)
* Any unstable medical health problem
* Any known pulmonary disorders, including tuberculosis, asthma, or COPD
* Pregnant or nursing
* Require benzodiazepines to control spasticity
* Require high doses of analgesic medications on a daily basis
Mental Health and Resilience in Emerging Adulthood

The purpose of this study is to examine differences in selected psychiatric/psychological variables between a sample of unemployed young adults who have dropped out of high school and a sample of college students.


Eligibility Criteria:
Inclusion Criteria:

* Subjects 18-25 years old who have dropped out of school and who are currently unemployed

Exclusion Criteria:

-
Assessment of a Probiotic to Treat Gingivitis in Pediatric Patients

This study investigates the efficacy of a proprietary probiotic formulation comprising 6 strains of bacteria in reducing inflammation and gingivitis in pediatric patients between 11 and 18 years old undergoing orthodontics treatment. Patients will be recruited based on a prior diagnosis of mild to moderate gingivitis by gingival index score. Participants in this study will be randomly assigned to receive either the probiotic treatment or a placebo, both in the form of a dissolving lozenge; for which the placebo is exactly the same shape, texture, taste, and composition as the probiotic treatment, but does not contain the active probiotic ingredients. The lozenges are to be taken orally at a certain prescribed regimen for 28 days. Participants will be assessed for gingivitis scores, gum bleeding scores, plaque scores, overall periodontal health, and for precarious areas at baseline, 14, and 28 days. They will also be assessed for the same measures at day 56, following a 28-day wash-out phase. Plaque and saliva samples will be collected at all timepoints for in vitro analyses of changes in microbial pathogens and/or inflammatory cytokines.


Eligibility Criteria:
Inclusion criteria:

* Are male or female between the ages of 11 to 18 years
* Have mild to moderate gingivitis as determined by dentist (GI of at least 1 to a maximum of 2)
* Are undergoing fixed orthodontic therapy on both arches with attachments on at least 20 teeth including bonded 1st molars for a minimum of 5 months.
* Have fully erupted teeth #16, #21, #23, #36, #41, and #43
* Are caries inactive prior to study initiation.
* Are in a healthy systemic condition
* Have not used any antimicrobial mouth rinses, probiotics (unrelated to the study), antibiotics or anti-inflammatories medications with one month prior to and during the study
* Whose legal guardian has given informed consent to participate in the study and must be able to communicate in English

Exclusion Criteria:

* Unable to make informed consent
* Subjects with allergies to milk or milk products, gluten or soy or any other ingredients present in the lozenge
* Immune compromised
* Major underlining medical condition
* Pregnancy
* History of smoking or alcohol consumption
* Have major dental conditions such as periodontal disease, dental caries and/or xerostemia or systemic diseases which could directly or indirectly affect plaque formation
* Use of medications within 1 month (antibiotics, anti-inflammatory, mouth rinses) that can influence the outcome.
* Ongoing or recent (within 1 month) use of probiotics unrelated to the study
* Have within the past 30 days experienced any nausea, fever, vomiting, bloody diarrhea or severe abdominal pain
Clinical Evaluation of Three Dental Adhesive Systems in Class V Restorations

The purpose of this study is to compare the clinical performance of three dental adhesive systems used to bond Class V cavity fillings in adult teeth.


Eligibility Criteria:
Inclusion Criteria:

* Must be at least 19 years of age
* Must have at least 3 qualifying noncarious Class V lesions of appropriate depth
* Must be willing to sign consent form
* Must be willing and able to return to UAB clinic for 4 study appointments
* Must be in good medical health and able to tolerate dental procedures

Exclusion Criteria:

* Current participation in other restorative product studies
* Severe salivary gland dysfunction
* Rampant caries (cavities)
* Chronic periodontitis (gum disease)
* Known allergies to the study materials
* Unacceptable level of oral hygiene
* Inability or unwillingness to attend study appointments
Phase I and II Study of Auranofin in Chronic Lymphocytic Leukemia (CLL)

The purpose of this study is to evaluate the safety and effectiveness of auranofin to treat patients with chronic lymphocytic leukemia (CLL), small lymphocytic lymphoma (SLL), or prolymphocytic lymphoma (PLL).


Eligibility Criteria:
Inclusion Criteria:

* histologically confirmed B-cell chronic lymphocytic leukemia (CLL), small lymphocytic lymphoma (SLL), prolymphocytic leukemia arising from CLL/SLL or Richter's transformation according to WHO criteria who require therapy based on the 2008 revised IWCLL criteria.
* Relapsed or refractory disease after receiving at least 1 prior therapy for CLL
* At least 18 years old; ECOG status of 1 or less; life expectancy 2 months or greater
* Adequate organ and marrow function (total bilirubin less than 1.5x IULN; ALT less than 2x IULN; serum creatinine less than 1.5x ULN)

Exclusion Criteria:

* have had chemotherapy, radiotherapy or immunotherapy within 4 weeks prior to entering study
* have not recovered from AEs due to agents administered more than 4 weeks prior
* receiving any other investigational agent
* known second malignancy that limits survival to less than 2 years
* known HIV positive
* uncontrolled intercurrent illness
* pregnant or breastfeeding
Improving Patient Experience: BMBA

This study seeks to determine if patients undergoing a bone marrow biopsy/aspiration (BMBA) procedure who receive distraction techniques have lower levels of distress and pain, and higher post-procedure satisfaction, compared to those receiving standard-of-care. Intervention 1 is guided meditation in a virtual reality (VR) headset. Intervention 2 is comprised of environmental changes to the room (via nature-themed decals) and music.

This study seeks to determine if patients undergoing a bone marrow biopsy/aspiration (BMBA) procedure who receive distraction techniques have lower levels of distress and pain, and higher post-procedure satisfaction, compared to those receiving standard-of-care. Intervention 1 is guided meditation in a virtual reality (VR) headset. Intervention 2 is comprised of environmental changes to the room (via nature-themed decals) and music.

Eligibility Criteria:
Inclusion Criteria:

* Provide signed and dated informed consent form
* Willing to comply with all study procedures
* Over 18 years of age
* Prior history of at least 1 (one) BMBA at Jefferson outpatient oncology office within the past 2 (two) years
* Visiting the Jefferson outpatient oncology office for a BMBA procedure during the study duration

Exclusion Criteria:

* Inability to read questions in English
* Inability to answer questions autonomously
* History of vertigo
* Legal blindness in both eyes
* Severe or profound hearing loss, or deafness
Health-related QoF Between OAB-wet and OAB-dry Women

Overactive bladder syndrome (OAB) has a great negative impact on health-related quality of life. In literatures, few studies reported the comparisons of health related quality of life between OAB-wet and OAB-dry female patients. Thus, our aim is to compare the clinical variables and health-related quality of life between OAB-wet and OAB-dry women.

Between July 2009 and January 2018, all women with OAB visiting a medical center for evaluation were reviewed. The classification of OAB-wet or OAB-dry is based on the record of the three-day bladder diary of each patient. The diagnosis of OAB in each patient was based on the presence of at least one episode of urgency in her three-day bladder diary and with the absence of stress urinary incontinence. The presence of at least one episode of urgency associated incontinence was defined to be OAB-wet, otherwise, OAB-dry. Besides, only female OAB patients with available King's Health Questionnaire (KHQ) data were reviewed in this study.

Eligibility Criteria:
Inclusion Criteria:

1. More than 20-year-old
2. Female
3. Diagnosed with overactive bladder by bladder diary

Exclusion Criteria:

1. Younger than 20-year-old
2. Pregnant or planned to be pregnant
Tumor Deposits in Colorectal Cancer and Its Prognostic Value in Survival and Metastasis

This study aims to evaluate the tumor deposits in colorectal cancer and its prognostic value in survival and metastasis

Tumor deposits (TDs) are defined as isolated tumor foci found in the pericolonic or perirectal fat or the adjacent mesentery (mesocolonic fat) away from the invasive margin of the tumor without evidence of residual lymphatic tissue. TDs are significantly correlated with poor prognosis after colorectal cancer surgery.

Eligibility Criteria:
Inclusion Criteria:

* Age above 18 years old.
* Both sexes.
* All Colorectal cancer patients From Stage I to III Colorectal cancer with pathologically positive Tumor deposits.

Exclusion Criteria:

* Patient took neoadjuvant therapy.
* No information available on tumor deposits.
* Colorectal cancer is not the only primary cancer.
* Patients with incomplete information about follow-up.
Efficacy of SEROQUEL in Selective Serotonin Reuptake Inhibitors (SSRI)-Resistant Major Depressive Disorder

An open-label, non-comparative, multi-centre, phase II prospective trial to assess the efficacy of Quetiapine fumarate augmentation of selective serotonin reuptake inhibitors (SSRIs) in SSRI-resistant major depressive disorder.


Eligibility Criteria:
Inclusion Criteria:

* Inform consent
* Male and female, age between 18 and 65 years.
* Naïve to any atypical antipsychotic
* A diagnosis of major depressive disorder

Exclusion Criteria:

* No use of fluvoxamine
* Patients with a history of bipolar I or II disorder
* Diagnosis of psychotic major depression disorder
Feasibility of Physical Activity in Older Adults With Haematological Malignancies: ACCES Study

The aim of this study is to implement a simple and unsupervised home-based physical activity (PA) program for cancer patients in 2 oncogeriatric units in Toulouse Hospital (day hospital and week hospital).

Cancer treatments can cause side effects such as fatigue and reduced muscle function. Studies have shown the benefits of physical activity, including reduced fatigue and improved quality of life. Moreover, PA is often recommended for cancer survivors rather than patients undergoing treatment. It is essential to develop adapted, unsupervised, home-based PA programs to ensure access to PA for all cancer patients, particularly those living in rural areas or who have difficulty accessing healthcare. The PA program CREATE is a simple, unsupervised PA program based on patients' functional capacities. Depending on the patient's functional capacity, one of 7 PA programs will be prescribed by the doctor. The patient must perform the program independently for 6 months. Telephone follow-ups (weeks 1, 2, 4, 6, 9, 12, 16, 20, et 24) as well as a monthly in-person follow-up visit will be made to adjust the prescription.

Eligibility Criteria:
inclusion criteria:

* suffering from a hematological malignancy (Myelodysplasia, Leukemia of any type, Lymphoma, Myeloma)
* patient affiliated to a social security insurance
* Patient undergoing or scheduled chemotherapy (\< 3 months) and/or immunotherapy and/or targeted therapy.

Exclusion criteria:

* Life expectancy estimated at less than 3 months by the unit doctor;
* Cognitive impairment (not allowing comprehension of the physical activity program and research project) defined by Mini-Mental State Examination (MMSE) \<20/30;
* Patient included in a clinical trial that potentially interferes with the study objective (geriatric interventional study, early drug study, study modifying the patient's lifestyle habits).;
* Acute health problem (fever, severe anemia, intense pain, etc.) limiting the possibility of involvement in the program;
* Contraindication to physical activity;
* Patient under legal protection (guardianship or curatorship or safeguard of justice);
* Refusal of patient or primary caregiver to participate.
Comparison of Viral Particle Dispersion Following Administration of an MDI or Nebulizer in Subjects With COVID-19

A randomized, 2-period crossover, single-center, open-label study for viral sample collection. After initiation of inhaled therapy with nebulizer or MDI, cascade impactors and surface samplers will be used to assess viral loads in rooms of subjects with COVID-19.

Observational Study Model = Other \[non-treatment; impact on external location (rooms and surfaces)\]

Time Perspective = Other \[viral load samples taken at various time points after nebulization or MDI administered\]

Sampling Method = Non-probability sample \[to be described by study team\]

Eligibility Criteria:
Inclusion Criteria:

1. Willing and able to provide written informed consent, either themselves or via legally acceptable representative, prior to undergoing study procedures
2. Willing and able to comply with study-related procedures/assessments
3. Adults over 18 years of age
4. COVID-19 infection as confirmed by PCR from nasopharyngeal, oropharyngeal swabs and/or saliva specimen taken within the previous 5 days

Exclusion Criteria:

1. Subjects currently receiving mechanical ventilation or noninvasive positive-pressure ventilation, or subjects who, in the opinion of the investigator, will require ventilatory support (i.e., mechanical ventilation or noninvasive positive-pressure ventilation) within the next 12 hours Note: Signs of impending need for ventilatory support include pronounced hypoxia despite supplemental oxygen \>6 L/min, prolonged respiratory rate (i.e., \>30 breaths per minute), signs of respiratory muscle fatigue, or paradoxical diaphragm.
2. Presence of significant comorbidity that, in the opinion of the investigator, makes the subject unsuitable for participation in the study
3. Known or suspected hypersensitivity to albuterol, history of paradoxical bronchospasm, or significant cough response to albuterol
4. Participating in other clinical trials related to COVID-19 thought to interfere with study interpretation (e.g., antivirals or antibodies that might change the viral load over the course of a day; subjects should not receive antibody therapy within 24 hours before the baseline period)
5. Active or incompletely treated pulmonary infections, such as tuberculosis (or known history of nontuberculosis mycobacterium) over past 12 months
6. Pregnant or currently breast feeding, or a positive urine pregnancy dip test performed at baseline (women only)
The Multiple Dose of PK/PD Study of SHR2285 Tablets in Healthy Subjects

The study is a randomized, single-blind, placebo-controlled, multiple-dose escalation Phase I trials. 2 dose groups were designed, 12 subjects in each dose group.The drug was administered single dose and multiple doses.


Eligibility Criteria:
Inclusion Criteria:

1. males or females, aged 18-45.
2. subjects with no cardiovascular disease, sitting blood pressure: 90mmHg ≤SBP\<140mmHg; 50mmHg ≤DBP\<90mmHg and 50 ≤ HR \<110 beats / min.
3. body mass index (BMI) between 18 to 28.
4. Participant in general good health. No clinically significant findings in vital signs, physical examination, 12-lead ECG ,X-ray and laboratory parameters.

Exclusion Criteria:

1. males or females, aged 18-45.
2. subjects with no cardiovascular disease, sitting blood pressure: 90mmHg ≤SBP\<140mmHg; 50mmHg ≤DBP\<90mmHg and 50 ≤ HR \<110 beats / min.
3. body mass index (BMI) between 18 to 28.
4. Participant in general good health. No clinically significant findings in vital signs, physical examination, 12-lead ECG ,X-ray and laboratory parameters.

Exclusion Criteria:

1. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) or total bilirubin/direct bilirubin \> 1X ULN during screening/baseline.
2. Serum creatinine\> 1X ULN during screening/baseline.
3. Abnormal coagulation function.
4. A clinical history of coagulation dysfunction; subjects with adverse reaction of antiplatelet drugs or anticoagulant drugs.
5. Subjects with severe head trauma or head surgery within 2 years or surgery within 3 months prior to the screening.
6. Blood donation or blood loss within 1 month≥200 mLor≥400 mL within 3 months before administration.
7. Human immunodeficiency virus antibody (HIV-ab), syphilis serological examination, hepatitis b virus surface antigen (HBsAg), hepatitis c virus antibody (HCV-ab) were positive.

8.3 months prior to screening involved in any drug or medical device clinical studies or within 5 half-life of drugs before screening.

9.Female subjects who did not receive contraception at least 30 days before administration.
Long-term Postoperative Outcomes After Bilateral Congenital Cataract Surgery in Eyes With Microphthalmos

Cataract surgery in infantile eyes, which are microphthalmic, can be even more demanding.

In addition, the frequent presence of other ocular and systemic anomalies such as nystagmus, glaucoma, amblyopia, and higher rate of postoperative complications may limit the success of cataract surgery.

In our previous study, the investigators examined the intraoperative performance and postoperative outcomes of bilateral cataract surgery in microphthalmic eyes of patients before their first birthday. At 1 year, the postoperative results showed that good visual outcomes could be obtained in microphthalmic eyes.

Since only a few studies have reported outcomes, and that too only short term of cataract surgery on microphthalmic eyes, in this prospective observational study we evaluated the long-term impact of bilateral cataract surgery on eyes with microphthalmos. The investigators examined the outcomes, complication rates, influence of age at surgery on pattern of axial growth and central corneal thickness and visual and orthoptic assessment in these eyes.


Eligibility Criteria:
Inclusion Criteria:

* Presence of microphthalmos and congenital cataract.
* Microphthalmos was defined as an eye with an axial length (AL) that is more than 2 SD smaller than the normal for that age group according to Gordon and Donzes

Exclusion Criteria:

- Children with congenital anomalies such as posterior persistent fetal vasculature causing stretching of the ciliary processes or a tractional retinal detachment, aniridia, and chorioretinal coloboma were excluded.