cyrilzakka/clinical-trials huggingface dataset:
NanoFUSE® PL Gutter PMCF

This study is a Post Market Follow Up Study to compare the fusion rates between the NanoFUSE® Bioactive Matrix (75%) w/autograft (25%) and autogenous bone in posterolateral gutter spinal fusion.

NanoFUSE® is indicated to be placed into bony voids or gaps of the skeletal system that are not intrinsic to the stability of the bony structure (i.e. the posterolateral spine and pelvis.) These defects may be surgically created osseous defects created from traumatic injury to the bone. NanoFUSE® must be used with autograft as a bone graft extender in the posterolateral spine. This product provides a bone graft substitute that remodels into the recipient's skeletal system. Radiographic success will be the primary judgement of success. All patient's achieving fused or probably fused status will be judged as a success.

Eligibility Criteria:
Inclusion Criteria:

* Grade I or II (less than 50% slip f the cephalic vertebra compared to the caudal vertebra) degenerative spondylolisthesis at one or two contiguous levels between L1 and L5
* Lumbar spinal stenosis at the same levels of the degenerative spondylolisthesis producing radiculopathy or neurogenic claudication unresponsive to a minimum of 3 months of nonsurgical treatment, or such patients with worsening neurological condition
* Patients who are medically suitable for surgical management and the use of NanoFUSE® Bioactive Matrix is consistent with product labeling
* Patients who have consented for surgical treatment
* Patients able to provide informed consent for the study and complete the questionnaires

Exclusion Criteria:

* Lytic spondylolisthesis
* Non degenerative stenosis (example: tumor, trauma, epidural, lipomatosis)
* Segmental kyphosis at the level of the spondylolisthesis
* Rheumatoid arthritis
* Active infection
* On long term disability or workers compensation claim
Effect of Simethicone on Screening Colonoscopy

This study is evaluating the effect of adding a high dose of simethicone to the standard polyethylene glycol preparation for screening colonoscopy in the quality of the preparation , adenoma detection rate and withdrawal times.

A proper bowel preparation is key to a thorough and safe colonoscopy. Several factors affect the mucosal visualization during colonoscopy, and consequently the quality of such evaluation. Undoubtedly, this can have unfavorable implications like missed lesions. One of the most commonly encountered scenarios is the presence of multiple bubbles that interfere with mucosal visualization. When this occurs, simethicone (an antifoam agent used to reduce bloating when ingested orally) is injected through the colonoscope to eliminate the bubbles and get a clear view of the mucosa. A few studies have used oral simethicone in conjunction with oral preparation agents (PEG, magnesium citrate, sodium phosphate) in an attempt to improve the quality of the preparation. Unfortunately these studies have not used the exact same preparation agent with and without simethicone, making it difficult to draw conclusions on its efficacy. However, it is important to understand that simethicone is not intended to decrease the amount of stool in the colon, and it's purpose is to decrease the amount of bubbles interfering with the visualization of the mucosa provided that there is no stool present . Furthermore, it is unclear if adding simethicone to a standard bowel preparation makes a significant difference in key aspects of screening colonoscopy such as adenoma detection rate or withdrawal times. This prospective randomized controlled, observer blinded study at Texas Tech University Health Sciences Center in El Paso, aims at studying the effect of simethicone on the overall colon preparation as well as on adenoma detection rate and withdrawal times.

Eligibility Criteria:
Inclusion Criteria:

1. Patients between the ages of 30-80 scheduled for screening colonoscopy.
2. Male and female patients
3. Ambulatory patients
4. Signed informed consent form

Exclusion Criteria:

1. Previous colonic surgery
2. Patient with mental/physical condition that impairs oral ingestion of preparation
3. Allergy or hypersensitivity to simethicone
4. Patients with limited mobility (bedridden patients)
5. Patients with gastrointestinal obstruction
6. Patients with gastroparesis
Confirm Safety and Performance of Avance Solo and Avance Solo Adapt NPWT Systems

The primary objective of this post market clinical follow-up (PMCF) investigation is to confirm the safety and performance of Avance®Solo and Avance®Solo Adapt NPWT Systems in low to moderate exuding chronic wounds when used in accordance with the Instructions for Use, for up to 28 days.

This investigation is designed as a prospective, open and non-comparative PMCF investigation to confirm the safety and performance of Avance®Solo and Avance®Solo Adapt in low to moderate exuding chronic wounds. This is a multi-center study that will take place in approximately 5 European countries. The target subjects are male or female, 18 years or older with low to moderate exuding chronic wounds (pressure ulcers (N=68), diabetic foot ulcers (N=34), and venous leg ulcers (N=34)) suitable for NPWT as deemed by the investigator. Two different options of Negative Pressure Wound Therapies (NPWT) will be evaluated through this clinical investigation

A total of 136 subjects will receive treatment with the investigational devices within the intended use according to Instructions for Use (IfU): Group 1: 102 subjects in total, 34 subjects per indication (pressure ulcers, diabetic foot ulcers, and venous leg ulcers) treated with Avance®Solo and Group 2: 34 subjects with pressure ulcers treated with Avance®Solo Adapt. Subjects will be managed and monitored for a maximum of 4 weeks or until withdrawal from investigation for any reason.

The primary performance endpoint will include assessment of wound progress compared to last visit during a maximum 28 days investigation period. Wound progression is determined by the Investigator and will take into account all aspects of wound characteristics. Wound progression will be assessed by the Investigator at each follow-up visit and measured by three outcomes:

* Deteriorated
* No change
* Improved

Eligibility Criteria:
Inclusion Criteria:

1. Male or female ≥ 18 years.
2. Signed written informed consent.
3. Low to moderate exuding chronic wounds (diabetic foot ulcers, venous leg ulcers and pressure ulcers for Avance®Solo or pressure ulcers for Avance®Solo Adapt) suitable for NPWT according to the investigator´s judgement and Instructions for Use.
4. Subjects that will be capable and willing to comply with protocol instructions

Exclusion Criteria:

1. Known malignancy in the wound or margins of the wound
2. Untreated and previously confirmed osteomyelitis
3. Non-enteric and unexplored fistulas
4. Necrotic tissue with eschar present
5. Exposed nerves, arteries, veins or organs
6. Exposed anastomotic site
7. Known allergy/hypersensitivity to the dressing or its components.
8. Known pregnancy or planning to become pregnant or lactation at time of study participation.
9. Participation in another investigative drug or device trial currently or within the last 30 days Subjects not suitable for the investigation according to the Investigator's judgement, Clinical Investigation Plan and Instructions for Use
Pharmacological Interaction of Rifampicin on Clindamycin in Staphylococcic Osteoarticular Infections

Clindamycin and rifampicin are authorized in osteoarticular infection treatment (IDSA guidelines) but some interaction is observed. The objective of this study is to evaluate and quantify rifampicin interaction on clindamycin

It could suggest modification of recommended doses or incitement to antibiotic dosage. Thus, theses antibiotics, if association is allowed, could limit fluoroquinolones prescription and avoid some antibiotic resistance.

Eligibility Criteria:
Inclusion Criteria:

* patients ≥18 years of age
* osteoarticular infection
* staphylococcus detected in bacteriological sampling
* sensibility to rifampicin, erythromycin and clindamycin
* active intravenous antibiotherapy against staphylococcus detected in bacteriological sampling

Exclusion Criteria:

* septic shock or severe initial sepsis
* osteoarticular infection with other microorganism than staphylococcus
* contraindication to clindamycin or rifampicin including case of hypersensibility to one of these two antibiotics
* pre-existing renal insufficiency or severe renal insufficiency (creatinine clearance \<30 ml/min)
* serious cognitive disorders
* patient under guardianship, trusteeship or non affiliated to social security or CMU (beneficiary or assignee)
* refusal to take part in the study and to sign the consent form
* pregnancy
* lactation
* administration of clindamycin or rifampicin within the month before inclusion
* treatment with enzymatic inductor or inhibitor within the month before inclusion
* participation to another study modifying antibiotic treatment administration
AK137 (Bispecific Antibody Targeting CD73 and LAG-3) in Patients With Advanced Malignant Tumors

A Phase I open label, dose-escalation and expansion study to evaluate the safety, tolerability, pharmacokinetics and antitumor activity of AK137 in patients with advanced malignant tumors.


Eligibility Criteria:
Inclusion Criteria:

1. Written and signed informed consent.
2. Eastern Cooperative Oncology Group (ECOG) Performance Score of 0 or 1.
3. Life expectancy ≥3 months.
4. Histologically or cytologically documented unresectable advanced or metastatic malignant tumor that has failed or intolerant of standard therapy, or for which no effective standard therapy is available.
5. Subject must have at least one measurable lesion according to RECIST Version1.1.
6. Adequate organ function.

Exclusion Criteria:

1. Any malignancy other than the disease under study within the past 3 years except for radically cured local cancers, such as basal cell skin cancer, carcinoma in situ of the cervix, or carcinoma in situ of breast.
2. Receipt of any anti-CD73, anti-LAG-3 treatment.
3. Experienced a toxicity that led to the permanent discontinuation of prior immunotherapy. All adverse events (AEs) while receiving prior immunotherapy have not completely resolved or resolved to Grade 1 prior to screening. Additionally, the use of immunosuppression other than corticosteroids was required.
4. Unresolved toxicities from prior anticancer therapy, defined as not having resolved to NCI CTCAE v5.0 Grade 0 or 1, or to levels specified in the inclusion/exclusion criteria, except for toxicities not considered a safety risk (e.g., alopecia, neuropathy, or asymptomatic laboratory abnormalities).
5. Major surgical procedure within 4 weeks prior to the first dose of AK137 or still recovering from prior surgery.
6. History of organ transplant.
7. Known allergy or reaction to any component of the AK137 formulation. History of severe hypersensitivity reactions to other mAbs.
Study to Evaluate the Effects of 90 mg Intravenous Infusions of GC4419 on the Single Dose Pharmacokinetics of Dextromethorphan in Healthy Adult Subjects

This will be a single center, phase 1, open-label, fixed-sequence study under fasting conditions to evaluate the effect of 90 mg intravenous (IV) infusions of GC4419 on the single-dose pharmacokinetic (PK) of dextromethorphan (DM) capsules liquid filled.


Eligibility Criteria:
Inclusion Criteria:

1. Male or female, non-smoker, ≥ 18 and ≤ 55 years of age, with BMI \> 18.5 and \< 30.0 kg/m2 and body weight ≥ 50.0 kg for males and ≥ 45.0 kg for females.
2. Healthy as defined by:

   1. the absence of clinically significant illness and surgery within 4 weeks prior to dosing.
   2. the absence of clinically significant history of neurological, endocrinal, cardiovascular, pulmonary, hematological, immunologic, psychiatric, gastrointestinal, renal, hepatic, and metabolic disease.
3. Females of childbearing potential must be willing to use acceptable contraceptive method throughout the study and for 30 days after the last study drug administration:
4. Male subjects must be willing to use acceptable contraceptive method from the first dosing until at least 90 days after the last study drug administration:
5. Male subjects (including men who have had vasectomies) with a pregnant partner must agree to use a condom from the first dosing until at least 90 days after the last study drug administration.
6. Male subjects must be willing not to donate sperm until 90 days following the last study drug administration.
7. Capable of consent.
8. Consent to perform genotyping for CYP2D6.

Exclusion Criteria:

1. Any clinically significant abnormality at physical examination, clinically significant abnormal laboratory test results
2. Positive urine drug screen or urine cotinine test at screening.
3. History of allergic reactions to GC4419, DM, or other related drugs.
4. Use of any drugs known to induce or inhibit hepatic drug metabolism within 30 days prior to the first DM administration.
5. Poor CYP2D6 metabolizers as determined by genetic testing.
6. Positive pregnancy test at screening.
7. Any reason which, in the opinion of the Principal Investigator, would prevent the subject from participating in the study.
8. Clinically significant ECG abnormalities or vital sign abnormalities
9. History of significant alcohol abuse within one year prior to screening or regular use of alcohol within six months prior to the screening visit
10. History of significant drug abuse
11. Participation in a clinical research study involving the administration of an investigational or marketed drug or device within 30 days prior to the first dosing, administration of a biological product in the context of a clinical research study within 90 days prior to the first dosing, or concomitant participation in an investigational study involving no drug or device administration.
12. Use of medication other than hormonal contraceptives and topical products without significant systemic absorption:
13. Donation of plasma within 7 days prior to dosing.
14. Breast-feeding subject.
Validation of Bedside Ultrasound to Predict Body Composition in Non- and Critically Ill Patients

The prospective study will include 200 patients and 50 critically ill patients, who had an abdominal computed tomography (CT) scan including the L3 level for any clinical reason. Ultrasound scans of the anterior thighs and forearms will be taken after the CT scan within 48 hours. Bioelectrical impedance analysis (BIA) will also be performed. In addition muscle strength, mobility, physical function and nutrition will be assessed. Primary outcome is the prediction of CT-based whole body muscle and fat volume and BIA-based fat and lean body mass from ultrasound-based muscle and fat thickness. Other secondary outcomes include the intra- and interrater reliability of the CT evaluation and ultrasound examination of muscle and fat mass. The relationship between clinical aspects (strength, mobility, physical function, nutrition) and whole body composition is another secondary outcome.


Eligibility Criteria:
Inclusion Criteria:

* cross-sectional abdominal CT scan including the level of L3 vertebra for any clinical reason
* study-related ultrasound examination must take place within 48 hours of CT

Exclusion Criteria:

* patients younger than 18 years
Clinical Study on Huatuo Zaizao Pills for Post-stroke Treatment

The purpose of this study was to evaluate the improvement of limb motor function and nerve function of patients with HTZZ during stroke rehabilitation. A total of 80 subjects will be randomly assigned to Huatuo Zaizao pill group or the control group.

This is a prospective, randomized controlled clinical trial. Eighty patients with phlegm and blood stasis block syndrome of ischemic stroke were randomly assigned to Hua Hua reconstruction group or control group at a ratio of 1:1. The treatment period is 12 weeks. The purpose is to evaluate its efficacy and safety, provide an objective basis for precise treatment of traditional Chinese medicine, and improve clinical efficacy. The main result is the changes of MAS scores 12 weeks days after taking the drug. The secondary result is the change in NIHSS, Fugl-Meyer and BI.

Eligibility Criteria:
Inclusion Criteria:

* 1.Aged between 35 and 75 years old
* 2.With a disease course between 2 weeks- 24weeks
* 3.Meeting the diagnostic criteria of ischemic stroke
* 4.Signed and dated written informed consent.
* 5.4≤NIHSS score≤22

Exclusion Criteria:

* 1.Unstable vital signs, or serious heart, liver, lung, kidney and other organ diseases
* 2.Exclude Transient Ischemic Attack(TIA)
* 3.Patients who are participating in clinical trials of other drugs within the past 1 month
* 4.Pregnant or breastfeeding women
* 5.Athletes, Epileptics, Allergic to this product
An Expanded Access Program to Provide Nintedanib to Patients With Non-IPF ILD Who Have no Alternative Treatment Possibilities

This Expanded Access Program is intended to facilitate the availability of OFEV to patients suffering from non Idiopathic Pulmonary Fibrosis-Interstitial Lung Disease (non IPF-ILD) with a progressive clinical course despite Standard of Care treatment and for whom no satisfactory authorised alternative therapy exists or who cannot enter a clinical trial.


Eligibility Criteria:
Inclusion Criteria:

None

Exclusion Criteria:

- Patients who are eligible for and can participate in an ongoing non Idiopathic Pulmonary Fibrosis-Interstitial Lung Disease (non IPF-ILD) study will be excluded from participation in this Expanded Access Program (EAP).
HLA Sensitization in Severely Burned Patients

Primary goal of this study is the analysis of HLA (Human leucocyte antigen) formation in severly burned patients. Potential HLA triggers in the treatment of severely burned patients are blood products, assist devices or temporary allogeneic skin. Besides that, inflammatory markers, such as WBC (white blood cell count), CRP (C-reactive protein), PCT (Procalcitonin) and two novel biomarkers (PSP (pancreatic stone protein), ST2) are to be investigated in severely burned patients.


Eligibility Criteria:
Inclusion Criteria:

* severely burned patients in need for hospitalization

Exclusion Criteria:

* hematologic diseases
* Cancer
Nature-Focused Mindfulness and Spiritual Well-being Among Adults with Moderate Prolonged Grief Symptoms

The goal of this randomized controlled trial is to evaluate whether a nature-focused mindfulness intervention can enhance spiritual well-being and reduce grief symptoms among adults with moderate prolonged grief symptoms. The main questions it aims to answer are:

Does a nature-focused mindfulness intervention improve spiritual well-being compared to an active control condition (noticing nature) and a waitlist control condition?

Does a nature-focused mindfulness intervention reduce grief severity and improve mental well-being, nature connectedness, selflessness, ability to adapt, personal recovery, and elevation compared to control conditions?

How do spiritual well-being, ability to adapt, nature connectedness, selflessness, grief reactions, and positive/negative affect change during the intervention period?

Researchers will compare a nature-focused mindfulness intervention to both a noticing-nature active control group and a waitlist control group to isolate mindfulness-specific effects from possible general nature exposure benefits.

Participants will:

Complete baseline, post-intervention, and follow-up assessments (at one and three months) Engage in either 10 sessions of nature-focused mindfulness practice or noticing nature activities over a two-week period (intervention and active control groups) Provide daily diary responses about their experiences throughout the 14-day intervention period


Eligibility Criteria:
Inclusion Criteria:

* Be a family member, spouse, or friend of a person who died at least 6 months prior to study enrollment;
* Be ≥18 years of age;
* Report moderate subclinical grief (score range from 47-70) based on the Traumatic Grief Inventory-Self Report Plus (TGI-SR+, Lenferink, Eisma, et al., 2022);
* Have access to a natural environment suitable for the intervention;
* Be willing and able to move in nature daily (with or without mobility assistance devices) and engage in brief mindfulness practices;
* Have sufficient Dutch language proficiency;
* Have access to Internet and mobile applications.

Exclusion Criteria:

* Acute suicide risk assessed in the screening step;
* A score lower than 47 or higher than 70 on TGI-SR+;
* Physical limitations that prevent moving outdoors for 30 minutes daily, even with mobility assistance devices.
High Confusion: Cannabis & Driving

This study is being done to assess the feasibility of administrating Δ9-THC and Δ8-THC isolates and simultaneously adopting several data harmonization measures to generate uniquely translatable data. This project aims to (1) evaluate the feasibility and acceptability of administering ∆9-THC and Δ8-THC isolates using standardized cannabis dosing units to quantify ∆9-THC and Δ8-THC pharmacokinetics; and (2) evaluate the feasibility and acceptability of adopting standardized impairment detection methods and driving performance definitions and measures on quantifying ∆9-THC and Δ8-THC driving impairment compared to a placebo.


Eligibility Criteria:
Inclusion Criteria:

* At least 18 years of age, no older than 49 years of age
* Recent cannabis use (within past two years)
* Good mental health as determined by self-reported responses to the Psychopathology Screener
* Absence of any major medical, cardiovascular, endocrine, and neurological condition as determined by self-reported responses to the Medical History Screener
* In possession of a valid drivers' license with at least two years of driving experience
* English-speaking (able to provide consent and complete questionnaires)
* Written Informed Consent

Exclusion Criteria:

* Any serious prior adverse response to cannabis
* History of or current substance use disorder as determined by self-reported responses to the Internalizing, Externalizing, and Substance Use Disorder Screener
* Pregnancy or lactation (pregnancy test, if needed)
* Use of medications that may impact driving ability (e.g., mood stabilizers, sedatives)