cyrilzakka/clinical-trials huggingface dataset:
A New Drug Delivery System - Silk Fibroin Film Loaded or Not With Insulin on Palatal Mucosa Wound Healing

The aim of the present study is to evaluate using clinical, patient-centered, immunological, microbiological, and histological parameters, the effect of silk fibroin films loaded or not with insulin in the repair of palatal mucosa open wounds.

There are several types of periodontal and peri-implant soft tissue defects that require surgical treatment to reestablishment function and aesthetics. Therefore, surgical procedures for the reconstruction of the gingival and peri-implant tissues are routinely performed. However, these procedures do not always have predictable outcomes, and problems with the wound healing process can occur, which can impair the outcomes. To overcome this problem, new materials, drugs, and devices have been used to improve the results of surgical procedures. The present study is a controlled clinical trial that will include seventy-five patients with an indication of anterior maxillary tooth extraction for ridge preservation. The ridge preservation will be performed and a free gingival graft harvest from the palatal mucosa will be used to seal the socket entrance. Thereafter, the palatal wound will be randomly assigned into 3 groups: Control Group (C; n=25): open wound on palatal mucosa that will receive no treatment. Blank Film Group (BF; n=25): open wound on palatal mucosa that will receive silk fibroin film as dressing. Insulin-loaded film (IF; n=25): open wound on palatal mucosa that will receive an insulin-loaded silk fibroin film as a delivery system. Clinical, immunological, histological, and microbiome parameters will be analyzed.

Eligibility Criteria:
Inclusion Criteria:

* Patients with at least 18 years, systemically healthy, with good oral hygiene, assessed by plaque index and gingival index less than 25% (Ainamo, Bay, 1975);
* Patients with no morphological or pathological conditions on the palatine donor area;
* Patients who present indication for extraction and ridge preservation;
* The tooth included in the study, as well as, the adjacent teeth do not present loss of periodontal insertion;
* Patients who agreed to and sign the formal consent to participate in the study after receiving an explanation of risks and benefits from an individual who was not a member of the present study (Resolution no. 118 - May, 2012, and Ethics and Code of Professional Conduct in Dentistry - 118/12).

Exclusion Criteria:

* Patients with systemic problems (cardiovascular, blood dyscrasias, immunodeficiency, and diabetes, among others) that will contraindicate the surgical procedure;
* Patients taking medications known to interfere with the wound healing process or that contraindicate the surgical procedure;
* Smokers patients;
* Pregnant or lactating patients;
* Patients who had had periodontal surgery on the study area;
* Patients who presents opportunistic oral lesions, mainly colonized the palate region;
* Use of dental prosthesis with palatal cover;
* Thin palatal mucosa (\~2.0mm).
Early Nutrition Intervention for M1 Stage Cancer Patients

In China, the treatment of advanced-stage cancer often follows a pattern where the management of patients is primarily overseen by oncologists who focus on addressing the main clinical symptoms and intervening accordingly.

However, symptoms such as appetite loss, weight loss, and anxiety are often overlooked. It is common for clinical nutritionists to passively enter oncology wards to conduct comprehensive nutritional assessments and develop nutrition plans only when patients exhibit significant malnutrition, upon request from oncologists or patients and their families.

Against this background, the investigators integrated clinical nutritionists into the oncology treatment team and established a proactive nutritional intervention team specifically targeting M1 advanced-stage cancer patients. This initiative aims to conduct a single-center, open-label, randomized parallel-group prospective study, with the following objectives: 1) to evaluate the impact of this model on the nutritional status, survival, and quality of life of advanced-stage cancer patients, and 2) to further optimize this model for widespread replication in clinical practice.


Eligibility Criteria:
Inclusion Criteria:

1. The patients should be at the range of 18-80 years old, Eastern Cooperative Oncology Group (ECOG) 0-1.
2. The patients should be diagnosed, untreated M1 advanced cancer patients requiring chemotherapy;
3. The patients should have good cognitive and reading abilities to complete questionnaires;
4. The patients should have ≥3 months expected survival period

Exclusion Criteria:

1. Patients with neurological or psychiatric disorders affecting cognitive function, including central nervous system metastases from tumors;
2. Patients with severe diseases affecting digestion, metabolism, or food intake;
3. Presence of contraindications to chemotherapy;
4. Patients in a cachectic state or refractory cachexia;
5. Patients requiring primary tumor radiation therapy.
6. Patients with PG-SGA score ≥9 points
Effect of TA-65MD on Healthy Volunteers

TA-65 MD® is pure, natural, plant-based compound that can help maintain or rebuild telomeres. A telomere is a region of repetitive DNA at the end of a chromosome, which protects the end of the chromosome from deterioration. They shorten during cell division and eventually signal an irreversible state of growth arrest known as cellular senescence. The length of a person's telomeres is an indicator of his or her overall health status; short telomeres have been associated with cellular aging and dysfunction.

The purpose of this clinical study is to evaluate the effects of TA-65 MD® on telomere length and on immunosenescence in subjects who have had 9 months of twice daily TA-65 MD® administration, compared to placebo. TA Sciences has developed different doses of TA-65® . The study intends to determine effect of four different doses of TA-65 MD® in terms of biomarkers, telomere length and overall health and sleep status.

Eligibility Criteria:
Inclusion Criteria:

1. Healthy adult males or females, based on medical history and current status.
2. Ages 45-75 years of age (inclusive at the time of Screening).
3. Voluntary consent and methods completion of a signed ICF (informed consent form).
4. BMI that is 18 to 40 kg/m2 (inclusive at the time of Screening).
5. Subjects who are able to understand and comply with protocol requirements, instructions, and protocol-stated restrictions.

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Exclusion Criteria:

1. History or presence of clinically significant cardiovascular, pulmonary, respiratory, hepatic, renal, hematological, gastrointestinal, endocrine, immunologic, dermatologic, neurological, or psychiatric disease which, in the opinion of the Investigator, would jeopardize the safety of the subject or impact the validity of the study results.
2. History of HIV, Hepatitis B, or Hepatitis C.
3. Females who are pregnant, planning to become pregnant during the study, or breastfeeding.
4. Recent or current medical condition that might significantly affect a pharmacodynamic response or compromise the safety of the subject or impact the validity of the study results in the opinion of the Investigator. (e.g., conditions that require taking diuretic medications and/or cardiac stimulants.)
5. Intake of the investigational product within 30 days prior to screening visit.
6. History of an allergic reaction to the study products or ingredient(s) or to comparable products in the opinion of the Investigator.
7. History of drug or alcohol addiction or abuse within 1 year prior to Day -1 product administration through end of study (EOS).
8. Donation of blood within 30 days or plasma within 7 days, prior to Day -1 product administration through EOS.
9. Intolerance to venipuncture or an inability to swallow capsules.

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Fruquintinib Combined With TAS-102 in Refractory Metastatic Colorectal Cancer

Fruquintinib, as a standard treatment for refractory metastatic colorectal cancer (mCRC), has attracted increasing research efforts to explore its innovative strategies in combination with immunotherapy and chemotherapy because of its multi-target mechanism which enhances the sensitivity of the immune system and chemotherapy, aiming to further improve the survival benefits for mCRC patients. Trifluridine/tipiracil (TAS-102) is also a standard treatment for mCRC. This study aims to investigate the safety and effectiveness of the combined use of these two drugs in mCRC.


Eligibility Criteria:
Inclusion Criteria:

* Histology-confirmed metastatic CRC (mCRC)
* Disease progression on standard therapy with at least two lines of chemotherapy, including fluorouracil, oxaliplatin, and irinotecan with or without biologics such as bevacizumab and cetuximab
* Fruquintinib administered as salvage treatment
* Age: 18-75 years old
* Informed consent

Exclusion Criteria:

* Liver or kidney dysfunction, or other conditions unsuitable for chemotherapy
* Fruquintinib and/or TAS-102 administration as second-line treatment
* Drug administration stopped after less than two cycles
Multi-Reader Multi-Case Controlled Clinical Trial to Assess the Fujifilm FFDM and DBT Reader Training Program

The purpose of this pilot is to assess the adequacy of the Fujifilm DBT Reader Study Training program to ensure that Readers participating in the Fujifilm DBT pivotal trial are properly trained in the reading and interpretation of FFDM and DBT images.

For this reader study, radiologists review images obtained via protocol FMSU2013-004A. They review both FFDM alone and FFDM + DBT images, and provide a BI-RADS and POM for each. The radiologists performance metrics for the following modalities will be evaluated: FFDM and FFDM + DBT.

Eligibility Criteria:
Inclusion Criteria:

* Female subjects participating in FMSU004A protocol with known clinical status

Exclusion Criteria:

* Subjects with unknown clinical status not participating in FMSU004A protocol.
The Post-operative Effect on Formation of Oedema After Total Knee Arthroplasty With or Without the Use of a Nerve Stimulator (the gekoTM Device)

This study will investigate whether the recovery of muscle function of total knee arthroplasty is accelerated with the use of the gekoTM device along with its effect on reducing symptoms such as oedema and inhibition of the muscle function.

This study will investigate total knee arthroplasty patients:

* One group gets standard of care (i.e. performing exercises \& guidance by a physiotherapist via a CE-marked mobile application, called moveUP)
* Second group gets standard of care + GekoTM device (i.e. non-invasive neuromuscular electrostimulation applied at the peroneal nerve for 10 days after the operation date.)

The primary objective of the study is to assess the post-operative effect of gekoTM on formation of oedema (measured by perometer).

The effect of the gekoTM device on the muscle function \& the overall recovery will be also investigated.

To collect parameters, the patient will be asked to complete questionnaires, including the following patient reported outcomes (PROMs): Knee Injury and Osteoarthritis Outcome Score (KOOS), Knee Society Score (KSS), Euroqol Health questionnaire EQ5D, Forgotten Joint Score (FJS), Oxford Knee Score (OKS).

The collection of the PROMs will give an indication on outcome and overal recovery in the 2 groups.

Eligibility Criteria:
Inclusion Criteria:

* Primary TKA planned for degenerative OA
* Subjects must be discharged to home environment and be able to independently perform the activities of daily life
* Obtain a written informed consent

Exclusion Criteria:

* TED stockings, Dauerbinde, other compressive bandages
* Mechanical foot pump
* Cooling device type 'Game Ready'
* Posttraumatic OA of the knee
* History of DVT / Flebitis / Pulmonary embolism
* Surgical treatment of venous insufficiency \<1y prior to TKA surgery
* Neurological deficit of lower limbs
* Current sciatic irradiating pain in lower limbs
* History of lumbar fusion
* Knee Arthroscopy of the involved limb \<6m prior to TKA surgery
* Any per-operative complication related to the TKA procedure (bleeding, fracture, vascular injury, cardiac complication, pulmonary complication)
* In case of a release during the TKA procedure
* Any per-operative (e.g. epidural catheter, urethral catheter, intra articular catheter) or post-operative procedure that might interfere with the rehabilitation during and after hospitalization
* Any scheduled surgery in the 3 months following the reference surgery;
* Any significant medical condition (e.g. Parkinson's disease, multiple sclerosis, cerebral vascular accident) that might interfere with the rehabilitation
* Any significant psychiatric disorders, active alcohol/drug abuse
* Subject is either pregnant or interested in becoming pregnant during the duration of the study
* Subjects who are currently involved in any investigational drug or device study or have been enrolled in such study within the last 3 months
Study in Paediatric Patients With Atopic Dermatitis Treated With Dupilumab in Spain

This is a multicentre, prospective, non-interventional study that aims to describe the treatment patterns of in Atopic dermatitis (AD) patients aged 6 months to 11 years old in Spain: patients' characteristics, disease characteristics, prior treatments for and treatment prescription modalities. As well as to document the real-world effectiveness and safety of dupilumab during the two years of follow up. No diagnostic or therapeutic intervention outside of routine clinical practice will be applied.


Eligibility Criteria:
Inclusion Criteria:

* Male or female aged 6 months to 11 years old at baseline.
* Patients with severe Atopic dermatitis (AD) according to the investigator's assessment.
* Patients initiating dupilumab (in those patients initiated retrospectively 2 months before the start of the study, the baseline information must be correctly filled out in the medical records).
* Signed informed consent by the parent/legally acceptable representative and assent by the patient appropriate to the patient's age.

Exclusion Criteria:

* Patients who are participating in an interventional clinical trial that modifies patient care.
Safety, Pharmacokinetics, and Efficacy of 100, 150, and 200 mg Risedronate Administered to Women With Low BMD

A Multi-center, Active-controlled (5 mg daily risedronate), Double-blind, Randomized, Sequential Escalating Dose Study to Assess Safety, Pharmacokinetics and Efficacy of 100, 150, and 200 mg Oral Risedronate Administered Monthly for Six Months in Postmenopausal Women with Low Bone Mineral Density.


Eligibility Criteria:
Inclusion Criteria:

* be postmenopausal 5 years based on medical history; follicle stimulating hormone and estradiol will be evaluated for any patient less than 65 years of age, who has undergone hysterectomy without bilateral oophorectomy, to ensure the patient is postmenopausal

Exclusion Criteria:

* use of any of the following medications within 3 months of starting study drug or use of any of the following medications for more than 1 month at any time within 6 months prior to starting study drug:

  * oral or parenteral glucocorticoids (5 mg prednisone or equivalent per day)
  * anabolic steroids
  * estrogen, raloxifene or estrogen-related drugs, eg, tamoxifen, tibolone, (except for low dose vaginal creams, tablets or insertable estrogen ring
  * progestogen
  * calcitonin
  * vitamin D supplements (greater than 800 IU per day)
  * calcitriol, calcidiol, or alfacalcidol
  * any bisphosphonate
  * fluoride (10 mg per day)
  * strontium and other bone active agents
  * parathyroid hormone
  * heparin, warfarin, and other similar anticoagulants
Feasibility Study: Conservative Treatment in Cervical Cancer

Currently conservative treatment for patients of childbearing affected by cervical cancer is reserved for women with FIGO stage IA2 - IB1 with tumor size less than 2 cm . The trachelectomy and the cone biopsy with pelvic lymphadenectomy are the choice for these patients wishing to preserve their reproductive function.

In this context , recently literature show the results about the use of neo-adjuvant chemotherapy about the reduction of tumor volume and therefore the magnitude of the subsequent surgical treatment (including patients with tumors larger than 2 cm ). So it becomes crucial a prospective analysis on the possibility to include in this type of treatment patients with stage IB1 and IIA1 with tumor size greater than 2 cm ( up to 4 cm ) .

The current study , in fact , would like to do a prospective evaluation on the advantages of neo-adjuvant chemotherapy in the possibility of broadening the inclusion criteria to conservative treatment in women , suffering from cervical cancer, stage IB1 and IIA1 ( with tumor volume between 2 and 4 cm) and wishing to preserve their reproductive function.

The investigators would like to be conservative in young patients affected by early stage cervical cancer.

Eligibility Criteria:
Inclusion Criteria:

* Squamous cervical cancer or adenocarcinoma in FIGO stage IB1-IIA, tumor volume between \> 2 and ≤ 4 cm (instrumental evaluation).
* Informed consensus
* Childbearing
* Fertility (through US and ormonal withdrawal pre - e post neoadjuvant chemotherapy
* ASA (American Society of Anesthesiologist) Class \< 2

Exclusion Criteria:

* ongoing pregnancy
Pilot Study of Sodium Nitrite in Resuscitated Cardiac Arrest Patients

Despite advances in cardiac arrest resuscitation survival from cardiac arrest is less than 20-30% and new therapies are urgently needed. Sodium nitrite infused during resuscitation from cardiac arrest has recently been shown to improve survival in a mouse model of cardiac arrest and our group is eager to test this hypothesis in a clinical trial. Our overall hypothesis is that an infusion of 2 μmole/kg sodium nitrite during resuscitation will increase the proportion of patients who will survive cardiac arrest. In preparation for a clinical trial, preliminary safety and efficacy data (phase 1) is needed which is the primary goal of this study.

Sixteen patients will be randomized to receive normal saline (n=5) or doses of IV nitrite (n=11). During the nitrite infusion and for 120 min after the infusion is completed, blood pressure and heart rate will be monitored.

The first 3 patients randomized to receive IV nitrite will receive the lowest dose (1 mg) of IV nitrite and compared to one placebo treated patient. If there is no significant decrease in blood pressure or elevation in heart rate, we will then dose escalate to the 6 mg dose in 4 patients and placebo in two patients. Dose escalation to the highest (14 mg) dose will again be contingent on the absence of significant hypotension or tachycardia in the drug treated patients compared to the pooled (n=3) placebo treated patients. The final block of patients will be randomized to the high nitrite dose (n=4) or placebo (n=2). Final comparisons of all groups will be made to the pooled (n=5) placebo group

Eligibility Criteria:
Inclusion Criteria:

* Successfully resuscitated from cardiac arrest by paramedics in the field Age 18 or older Comatose IV access

Exclusion Criteria:

* traumatic cause of cardiac arrest known DNAR Patient requiring vasopressors at time of randomization SBP \<105 PaO2 of less than 90% on FiO2 of 1.0
Gas Exchange and CT Effects of PEEP in ARDS

The study aims to investigate the association between effects of PEEP on gas exchange model parameters and CT scan results

In ARDS patients on mechanical ventilation, we will compare model-based estimation of gas exchange parameters (shunt, ventilation/perfusion mismatch) with CT-based estimation of effects of low and high PEEP

Eligibility Criteria:
Inclusion Criteria:

- ARDS patients requiring mechanical ventilation

Exclusion Criteria:

* \<18 years old
* Requirement of extracorporal life support
* Hemodynamic instability
* Barotrauma
Effect of Barley Supplemented Wheat Bread on Markers of Cardiovascular and Renal Health

The disruption of colonic microbiota has been linked to a number of diseases, mainly cardiovascular and kidney diseases. One possible means to improve the microbiota is to increase dietary fiber intake as the intake of dietary fiber shifts the fermentation from proteolytic saccharolytic fermentation.

Beta-glucans are soluble dietary fibers mainly found in oats and barley. Results from previous studies suggest that the consumption of barley reduces the risk of cardiovascular and kidney diseases. Therefore, this study will explore the effect of barley beta-glucans on markers of Cardiovascular and Renal health.


Eligibility Criteria:
Inclusion Criteria:

* Healthy individuals of age 18 years or older
* BMI ranged between 18.5 and 24.9

Exclusion Criteria:

* Celiac disease, Cancer, Diabetes , cardiovascular diseases
* Gastro intestinal tract disease
* Pregnant women
* Use of pre-, pro- or antibiotics 15 days before the enrollment into the study
* Food allergy to food used in the trial
Single Position Spine Surgery Registry

The purpose of this study is to systematically, prospectively compare surgical fusion techniques for thoracolumbar spinal fusion patients and assess long-term patient outcomes and revision rates following surgery.

The goal of this study is to understand how the difference in positioning of a patient intraoperatively, as part of performing an anterior posterior spine fusion surgery, can affect short term and long term outcomes. This will be accomplished through observational techniques that will not affect the care patients will receive for their spinal conditions.

Patients will be asked to complete health and wellness surveys before and after survey to determine how they are doing before surgery and then what if any changes their respective surgeries have had on their lives. Further spine x-rays that they have taken to plan their surgeries and assess their recovery will be measured, when available. X-rays will not be taken only for research purposes. Additionally aspects of their surgeries will be noted such as where hardware is placed and how long different parts of the surgery took.

Follow-up is planned to be out to 10 years post-operatively with the goal of collecting information about any revision spine surgeries that would happen during those 10 years as well.

Eligibility Criteria:
Inclusion Criteria:

1. Age greater than or equal to 18 years
2. Ability to speak and read comfortably in English
3. Affliction by a spinal condition warranting evaluation for operative treatment

Exclusion Criteria:

1. Current incarceration
2. Individuals incapable of consenting and/or objectively responding to surveys, irrespective of reasonable assistance
3. Women currently pregnant or expecting to become pregnant in the near future
4. Subjects participating in another research study, whose protocol would conflict with comprehensive participation in this study
5. Subjects with psychiatric pathology which may impair judgement or the ability to give informed consent.