cyrilzakka/clinical-trials huggingface dataset:
To Access the Effects of Mucositis in Adults With Dental Implants

Clinical research for the treatment of mucositis subjects who have dental implants for a minimum of one-year.


Eligibility Criteria:
Inclusion Criteria:

* Male and female subjects, ages 30-70.
* Availability for the six-month duration of the clinical research study.
* Good general health.
* Subjects who have lost teeth for periodontal disease reasons and who have been restored with implants.
* Minimum of 5 remaining teeth and a minimum of 2 implants.
* Initial evaluation of the gingival and peri-implant mucosal tissues by determining full mouth bleeding on probing.
* Initial plaque evaluation by determining full mouth presence/absence of plaque.
* Signed Informed Consent Form.

Exclusion Criteria:

* Tumor(s) of the soft or hard tissues of the oral cavity.
* Untreated periodontal disease (purulent exudate, tooth mobility, and/or extensive loss or periodontal attachment or alveolar bone).
* Carious lesions requiring immediate restorative treatment.
* Uncontrolled Diabetes
* Use of antibiotics any time during the one month prior to entry into the study.
* Untreated peri-implantitis.
* Participation in any other clinical research study or test panel within the three months prior to entry into the study.
* Pregnant women or women who are breast feeding.
* History of allergies to personal care/consumer products or their ingredients.
* Medical condition which prohibits not eating/drinking for up to 2 hours.
* Current alcohol or drug abuse.
* Systemic or local disease conditions that would compromise post-operative healing.
* Regular use of anti-inflammatory drugs.
SPECTAlung: Screening Patients With Thoracic Tumors for Efficient Clinical Trial Access

SPECTAlung is a program aiming at screening patients with thoracic tumors to identify the molecular characteristics of their disease. The thoracic tumors include lung cancer, malignant pleural mesothelioma, thymoma or thymic carcinoma at any stage. Once the molecular characteristics are identified, there might be the possibility to offer these patients access to targeted clinical trials.


Eligibility Criteria:
Inclusion Criteria:

* Pathologically confirmed lung cancer, MPM, thymoma or thymic carcinoma at any stage;
* Mandatory availability of adequate Human Biological Material (HBM): FFPE tissue sample from the primary tumor, recurrent tumor, metastasis, obtained at the time of primary surgery or biopsy; minimal amount requested is detailed in the HBM guidelines; inclusion of samples taken at any recurrence diagnosed during follow-up is strongly encouraged but optional;
* Centrally performed confirmation of tumor tissue adequacy in terms of quality/ quantity for central screening;
* Age ≥ 18 years;
* At least three months life-expectancy;
* Written informed consent according to ICH/GCP and national/local regulations.

Exclusion Criteria:

* Any active malignancy, except pT1-2 prostatic cancer Gleason score \< 6, non melanomatous skin cancer or carcinoma in situ of the cervix, in the 5 years before study entry;
* Active hepatitis B/C or HIV;
* Any secondary malignancy;
* Any severe organ dysfunction or other comorbidities that may prevent the inclusion into clinical trials.
Reliabilty and Validity of a Diagnostic Interview for Parents of Babies and Preescholers

The Kleinkind-DIPS (Diagnostisches Interview bei psychischen Störungen für Kleinkinder) is a structured interview to assess a variety of the most frequent psychological problems in babies and preschoolers, e.g. feeding or sleeping problems, anxiety disorders. It is administered by a trained clinician with one of the primary carers. In this study, its acceptance, reliability and validity will be tested in a clinical and non-clinical sample.

The Kleinkind- DIPS (Diagnostisches Interview bei psychischen Störungen für Kleinkinder) is a structured interview to assess a variety of the most frequent psychological of the most frequent psychological problems in babies and preschoolers, e.g. feeding or sleeping problems, anxiety disorders. It is administered by a trained clinician with one of the primary carers. In this study, its acceptance, reliability and validity will be tested in a clinical and non-clinical sample. Parts of the interview are adapted from the Kinder-DIPS, for which information on acceptance, reliability and validity are available. The aim of the present study is to test the interviews acceptance, reliability and validity in both a clinical and a non-clinical sample.

Eligibility Criteria:
Inclusion Criteria: sufficient knowledge of the German language -

Exclusion Criteria:

-
Personalized Experiences to Inform Improved Communication for Patients With Life Limiting Illness

Disparities in palliative care for patients with serious illness exist because of gaps in knowledge around patient centered psychological, social, and spiritual palliative care interventions. Patient-centered palliative care communication interventions must be informed by the perspectives of patients who are living each day with their serious illness. Yet, there is a lack of research about how to efficiently and effectively integrate the patient's narrative into the electronic health record (EHR). The central hypothesis of this proposal is that the implementation of a patient-centered narrative intervention with patients with serious illness will result in improved patient-nurse communication and improved patient psychosocial and spiritual well-being.

The overall goal during this study will be to conduct a small scale pilot study with 80 hospitalized patients and 80 acute care nurses. Specific Aim 1 will establish acceptability, feasibility, and potential effect size of the patient-centered narrative intervention for hospitalized patients with serious illness. For specific aim 2, the investigators will compare the effects of the narrative intervention to usual care for the primary outcome of patient's perception of quality of communication and patient's psychosocial and spiritual well-being. For specific aim 3, the investigators will conduct usability testing, applying a user-task-system-environment evaluation process to determine essential requirements for integration and use of the patient-centered story into the EHR, from the perspective of an important end user: the acute-care bedside nurse. These results will support future R01 applications for testing/tailoring patient-centered narrative interventions to improve QoL for patients living with serious illness.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 years or older.
* Has ability to read English.
* Capable of giving informed consent.
* Has diagnosis of at least one serious illness. For this study, the eligible diagnoses include: 1) New York Heart Class III or IV heart failure and/or 2) dialysis-dependent renal failure

Exclusion Criteria:

- None.
A Clinical Trial to Assess Subjects With Dry Eye Disease.

A Multi-Center Randomized, Double-Masked, Parallel Design, Vehicle-Controlled Phase 2 Clinical Trial to Assess the Efficacy and Safety of 0.25% Reproxalap Ophthalmic Solution Compared to Vehicle in Subjects with Dry Eye Disease


Eligibility Criteria:
Inclusion Criteria:

1. 18 years of age (either gender and any race);
2. Reported history of dry eye for at least 6 months prior to Visit 1;
3. Reported history of use or desire to use eye drops for dry eye symptoms within 6 months of Visit 1.

Exclusion Criteria:

1. Clinically significant slit lamp findings at Visit 1 that may include active blepharitis, meibomian gland dysfunction (MGD), lid margin inflammation, or active ocular allergies that require therapeutic treatment, and/or in the opinion of the investigator may interfere with study parameters;
2. Diagnosis of an ongoing ocular infection (bacterial, viral, or fungal), or active ocular inflammation at Visit 1;
3. Contact lens use within 7 days of Visit 1 or anticipate using contact lenses during the trial;
4. Eye drop use within 2 hours of Visit 1;
5. Previous laser-assisted in situ keratomileusis (LASIK) surgery within the last 12 months;
6. Cyclosporine 0.05% or 0.09% or lifitegrast 5.0% ophthalmic solution use within 90 days of Visit 1;
7. Be receiving systemic corticosteroid therapy (not including inhaled corticosteroids) within 14 days of Visit 1 or anticipate such therapy throughout the study period;
8. Planned ocular and/or lid surgeries over the study period or any ocular surgery within 6 months of Visit 1;
9. Temporary punctal plugs during the study that have not been stable within 30 days of Visit 1.
Pilot Study of the Neuro-Spinal Scaffold for the Treatment of AIS A Cervical Acute SCI

Pilot Study of Clinical Safety and Feasibility of the Neuro-Spinal ScaffoldTM for the Treatment of Complete (AIS A) Traumatic Acute Spinal Cord Injury at the C5-T1 Neurological Levels The purpose of this study is to support an expansion to support marketing applications as well as future studies.


Eligibility Criteria:
Inclusion Criteria:

* 16-70 years of age, inclusive
* AIS A classification of traumatic spinal cord injury with a neurological level within C5-T1 inclusive
* Recent injury
* Non-penetrating SCI

Exclusion Criteria:

* Terminally ill subjects not likely to be able to participate in follow-up
* Incomplete spinal cord injury (AIS B, C, D, and E injuries)
* No identifiable intra-spinal cavity following myelotomy/irrigation in the contused spinal cord in which a Scaffold can be placed
* Spinal cord injury associated with significant traumatic brain injury or coma that
* Radiographic or visual evidence of parenchymal dissociation or anatomic transection as determined by the Investigator where the contusion completely bridges a full cross-section of the spinal cord
* Subjects with spinal cord injuries directly due to gunshot, knife, or other penetrating wounds
Intubation Prediction in COVID-19 Patients Treated With Awake Prone Positioning

Retrospective study in Sars-Cov 2 patients hospitalised in ICU. We aim to explore the effects of Awake prone positioning on oxygenation and intubation rate.


Eligibility Criteria:
Inclusion Criteria:

* Sars-CoV-2 pneumonia
* ICU stay
* Severe hypoxemia but non intubated

Exclusion Criteria:

* Intubated before admission
* Denied consent for data analysis
* Do not intubate order at ICU admission
99mTc-MY6349 SPECT/CT Imaging in Trop2-positive Triple-negative Breast Cancer

Human trophoblast cell-surface glycoprotein antigen 2 (Trop2) is a membrane surface receptor that plays an important role in the occurrence and development of tumors. Studies have shown that Trop2 is highly expressed in a variety of cancers (such as breast cancer, lung cancer, gastric cancer, colorectal cancer, pancreatic cancer, prostate cancer, cervical cancer, head and neck cancer, and ovarian cancer, etc.) and is related to the proliferation, invasion, and metastasis of tumor cells. and other processes related. According to statistics, more than 80% of breast cancer patients highly express Trop2, and high expression of Trop2 is positively correlated with shortened survival and poor prognosis of cancer patients. In this study, a single-domain antibody targeting Trop2 was selected to prepare a new nuclear medicine molecular probe 99mTc-MY6349, so as to monitor the expression level of Trop2 in patients' systemic tumors through SPECT/CT imaging. Breast cancer patients who intend to use gosatuzumab for subsequent treatment can first undergo 99mTc-MY6349 SPECT/CT imaging to detect Trop2 expression levels in systemic tumors. Subsequently, 18F-FDG PET/CT imaging was performed to compare and detect the distribution of primary tumors and systemic metastases in patients with breast cancer. This study analyzes the heterogeneity of Trop2 expression levels within the primary tumor and the heterogeneity of expression levels in systemic metastases, thereby providing a basis for testing whether the patient is suitable for subsequent treatment and conducive to the formulation of subsequent treatment plans.


Eligibility Criteria:
Inclusion Criteria:

* Female, aged between 18 and 80 years old.
* Patients with suspected or definite diagnosis of triple-negative breast cancer.
* Patients with suspected or confirmed triple-negative recurrent or metastatic breast cancer.
* Female subjects must have medical records to prove that they have undergone surgical sterilization (such as hysterectomy, bilateral oophorectomy, or tubal ligation) or have been menopausal for more than one year; if they still have the ability to conceive, isolation contraceptive measures must be taken during this study period.

Exclusion Criteria:

* Suffering from severe gastrointestinal, cardiovascular, liver, kidney, blood system, endocrine, respiratory system, immune deficiency and other serious diseases.
* Claustrophobia.
* In the past year, due to other clinical medical treatment or scientific research needs, received ionizing radiation outside the scope of this experiment, so that the annual radiation exposure dose exceeded 50mSv.
* Pregnant or lactating women.
* Received experimental drug or device treatment (with unclear efficacy or safety) within 1 month.
* There is any situation in which the conductor of this study believes that any aspect related to this experiment may cause harm or be potentially harmful.
The MOTION Study - Treatment of LSS With the MILD Procedure

Prospective, multicenter, randomized controlled clinical study examining functional improvement in lumbar spinal stenosis (LSS) patients with neurogenic claudication who are treated with the MILD procedure plus conventional medical management (CMM) compared to those treated with CMM alone, as the control. Subjects in the control group are able to crossover and receive MILD after completion of 12-month follow-up. The study will provide objective functional improvement data for patients treated with the mild Procedure as first-line therapy in a real-world setting.

The study will follow participants treated in the MILD plus CMM group and crossover participants for up to 5 years on annual bases.

Eligibility Criteria:
Inclusion Criteria:

* Patients experiencing neurogenic claudication symptoms for at least 3 months duration.
* LSS with neurogenic claudication
* Radiologic evidence of LSS with unilateral or bilateral ligamentum flavum ≥ 2.5mm confirmed by pre-op MRI or CT performed within 12 months of baseline visit.
* Patients with comorbid conditions commonly associated with spinal stenosis, such as osteophytes, facet hypertrophy, minor spondylolisthesis (Grade I without instability), foraminal stenosis, and/or disk protrusion may be included unless the treating physician has determined that the condition is too advanced.
* Stable opioid intake with no change during 30 days prior to enrollment.
* Available to complete all follow-up visits.

Exclusion Criteria:

* ODI Score \< 31 (0-100 ODI Scale).
* NPRS Score \< 5 (0-10 NPRS Scale).
* Lumbar epidural injections during eight weeks prior to study enrollment.
* Baseline analgesic medication greater than 90 milligram morphine equivalent (MME).
* Prior surgery at the same treatment level.
* Previously received interspinous spacer at the same treatment level.
* Previously received intradiscal procedure at the same treatment level.
* Previously received vertebral augmentation procedure at the same treatment level.
* Previously received the MILD procedure at the same treatment level.
* Received radiofrequency ablation at the same or the adjacent levels within 6 months prior to study enrollment.
* History of spinal fractures with current related pain symptoms.
* Grade II or higher spondylolisthesis.
* Motor deficit or disabling back and/or leg pain from causes other than LSS neurogenic claudication (e.g. acute compression fracture, metabolic neuropathy, or vascular claudication symptoms, etc.).
* Unable to walk ≥ 10 feet unaided before being limited by pain. In this context, 'unaided' means without the use of a cane, walker, railing, wall, another person or any other means of walking assistance.
* Previously randomized and/or treated in this clinical study.
* Epidural lipomatosis (if it is deemed to be a significant contributor of canal narrowing by the physician).
* On (or pending) Workman's Compensation or known to be considering litigation associated with back pain.
Physiotherapy/hypnosis for AVC Patients

Impact of physical therapy with hypnosis on the functional capacity of the upper limb in stroked patients.

The cerebrovascular accident (CVA) is a pathology generating many disabled people. Physiotherapy is one of the usual rehabilitation techniques for a patient with sequelae of ischemia or cerebral hemorrhage. Combined with another therapeutic approach, hypnosis, it could increase the patient's motor performance.

Eligibility Criteria:
Inclusion Criteria:

* Adults aged 18 to 80 years old
* Having experienced a stroke more than 3 months ago
* Understanding and proficient in the French language
* Having a functional capacity deficit in at least one of the two upper limbs
* Being able to independently travel to the Yerne medical center for necessary study appointments.

Exclusion Criteria:

* Being under 18 or over 80 years old
* Having a history of upper limb injuries (fractures, prosthetics, etc.)
* Having Wernicke's aphasia (language comprehension disorder)
* Having frontal lobe syndrome
* Undergoing chemotherapy
* Having respiratory disorders (respiratory failure of more than 70%) or receiving oxygen therapy
* Having epilepsy
* Having dementia
* Having untreated hearing impairments
* Being diagnosed with schizophrenia or paranoïa
* Experiencing significant concentration difficulties
Effect of Meal Texture on Glucose-metabolism and Gut Hormone Response After Bariatric Surgery

The investigators want to evaluate the difference in glucose metabolism and intestinal hormonal response after a liquid meal versus a solid meal in patients after bariatric surgery.


Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years
* RYGB or SG operation \> 12 months prior to inclusion
* Weight stable (± 3 kg during the last month)
* HbA1c \< 48 mmol/mol before surgery, and no history of diabetes
* HbA1c \< 48 mmol/mol and fasting plasma glucose \< 6.1 mmol/l at inclusion

Exclusion Criteria:

* Thyrotoxicosis or inadequately treated hypothyreosis
* Hemoglobin \< 6.5 mmol/l at inclusion
* Pregnancy or breast feeding
* Medication affecting the planned examinations
Comparison of Tele-rehabilitation Versus In-clinic Rehabilitation for Upper Limb Motor Function Stroke Patients

To determine the effects of Tele-rehabilitation versus in-clinical rehabilitation for upper limb motor function and spasticity in chronic ischemic stroke patients.


Eligibility Criteria:
Inclusion Criteria:

* • Patients from both genders.

  * Patients with chronic ischemic stroke i.e. 6 months or more.
  * Patients with 45 years old and above.
  * On modified Ashworth scale, patient with limb spasticity equal to 2 or less than 2.
  * On Mini Mental State Examination (MMSE), patients with good cognitive function minimum 24 or more.

Exclusion Criteria:

* • Patients with any recurrent stroke history.

  * Cognitive deficit patients (on Folstein Mini Mental state Examination score of less than 24)
  * Patient having other neurological diseases.
Pilates Training in Patients With Allergic Rhinitis

The purpose of this study was to determine the effects of pilates training on symptoms in patients with allergic rhinitis.

Twenty allergic rhinitis patients aged 18 - 35 years were randomized into 2 groups: control group (CON; n=9) and pilates training group (PTG; n=11). Participants in CON group do their daily routine without receiving any training program, while those in PTG group completed receiving pilates training program three time a week for ten week-long (60 minutes/time). The physiological data, rhinitis symptoms, cytokines, pulmonary function, respiratory muscle strength were analyzed during the pre-test and post-tests. The dependent variables between pre-test and post-tests were analyzed by paired t-test. The rhinitis symptoms and cytokines variables between pre-test and post-test were analyzed by repeated measures ANOVA. In addition, an independent t-test was used to compare the variables between groups. Statistical significance was defined as p \< .05.

Eligibility Criteria:
Inclusion Criteria:

* the persistent allergic rhinitis who had rhinitis symptoms more than 4 days a week and positive skin prick test to house dust mite were recruited
* stopped taking all medicine before the study sus as antihistamine for 3 days, oral steroid and nasal steroid for at least 2 weeks and leukotriene receptor antagonist for at least a week prior to the study
* had no exercise program, non-smoking and without any food supplementation for at least 6 months prior to the start of the study

Exclusion Criteria:

* had complications with allergic rhinitis, sinusitis, ear tube malfunctions, asthma, lung cancer, emphysema, lower back pain, tendinitis and arthritis
Effect of Peritoneal Lavage With Clindamycin-gentamicin on Laparoscopic Sleeve Gastrectomy

A prospective, randomized study will be performed in patients undergoing laparoscopic sleeve gastrectomy (LSG) as bariatric procedure. The patients will be randomized into 2 groups: those patients undergoing an intra-abdominal lavage with normal saline (Group 1) and those undergoing an intra-abdominal lavage with a gentamicin-clindamycin solution (Group 2). Postoperative pain and C reactive protein will be investigated 24 hours after surgery.

A prospective, randomized study will be performedin patients undergoing laparoscopic sleeve gastrectomy (LSG) as bariatric procedure. The patients will be randomized into 2 groups: those patients undergoing an intra-abdominal lavage with normal saline (Group 1) and those undergoing an intra-abdominal lavage with a gentamicin-clindamycin solution (Group 2). Postoperative pain and C reactive protein will be investigated 24 hours after surgery.

Eligibility Criteria:
Inclusion Criteria:

* Body mass index (BMI) \>40 Kg/m2
* BMI \> 35 Kg/m2 with the presence of comorbidities associated to obesity
* Patients undergoing laparoscopic sleeve gastrectomy (LSG) as bariatric procedure.

Exclusion Criteria:

* Gastroesophageal reflux
* Preoperative diagnosis of chronic renal failure
* Uncontrolled psychiatric disorders
* Active infections
* Malignancies
* Any other concomitant pathology considered as a contraindication for bariatric surgery.