cyrilzakka/clinical-trials huggingface dataset:
DOvEEgene Fleur: New Uterine Sampling Tool

This study is related to a previous study from the same group which started in 2014 (NTC02288676, McGill REB A08-M79-13B, MUHC REB 2020-5945) to develop a clinically implementable screening test -DovEEgene: developing and validating a novel molecular test for the early diagnosis of cancer of the endometrium, tubes and ovaries. This study is designed to identify endometrial, tubal and ovarian cancer very early based on identifying cancer-specific mutations (cancer DNA) in a pap sample taken from inside the uterus. The results are particularly encouraging given that control group is challenging with high background mutational burden from benign tumours, endometriosis, germ-line mutations etc.

To date, all the intrauterine samples were obtained using the commercially available TAO brush™ which is designed to take an endometrial sample. However, when patient tolerability was assessed using a numerical pain scale (NPS) ranging from 0 (no pain) to 10 (severe pain), patients rated the sampling using the TAO brush™ at 3.5 versus 0 for a cervical pap sample. These results were not surprising as the TAO brush™ was designed for dislodging strips of endometrial tissue to use for histopathologic examination. With respect to the investigators objective, which is to collect cancer cells that have exfoliated to the uterus, a sampler that collects these exfoliated cells with as little disturbance as possible to the underlying endometrium is preferred. In this sub-study, the investigators aim to evaluate a new endometrial sampling tool, the DOvEEgene Fleur, which is believe to be superior to the current TAO brush™ in terms of cancer detection, ease of use and patient tolerability. The sampler has been designed using materials/components found in the TAO brush™ and other approved medical devices.


Eligibility Criteria:
Inclusion Criteria:

* Be at least 18 years of age.
* Have capacity to understand the study.
* Be able to provide informed consent.
* If the patient has a recently treated cervical abnormality, she must have had a Pap smear with normal results at least 4 months following treatment by loop electrosurgical excision procedure (LEEP) or cone biopsy.
* Have suspected or confirmed cancer of the upper genital tract and be undergoing surgery for said tumor removal.

Exclusion Criteria:

* Prior hysterectomy.
* Be pregnant or possibly pregnant.
* Be nursing, as the device contains phthalates (plasticizers) that "have not been fully characterized and there may be concern for reproductive and developmental effects".
* Have an infected or inflamed cervix.
* Have a confirmed or suspected pelvic infection.
* Have a confirmed or suspected vaginal infection.
* Have had recent history of uterine perforation.
* Patients with recently treated cervical abnormalities must have a Pap smear with normal results at least 4 months following treatment by loop electrosurgical excision procedure (LEEP) or cone biopsy in order to be eligible.
Toxicity of Treatments for Non-tuberculous Mycobacterial Infections in Cancer Patients or Not

Non-tuberculous mycobacteria (NTM) are increasingly common and have a poor prognosis: 5-year mortality can reach 40 to 50%, depending on the type of mycobacteria and the immune system of the host involved. Cancer patients are at higher risk of infectious morbidity and mortality, which may be due to disease-related immune dysfunction, immunosuppressive effects of chemotherapy, or long-term placement of a vascular catheter. However, data on the treatment of NTM species that cause infections and the disease characteristics of these pathogens in cancer patients are limited despite the growing cancer population worldwide. Recently, M. avium infections have been described in patients suffering from cancers (hematological or not), in particular in patients receiving checkpoint inhibitors. Although the proportion of M. avium pneumonia in retrospective series is low (0.8-2%), it has been shown that this population is younger, suffers less from sub-pulmonary pathology. (indicating immunosuppression in these patients) but are therefore treated less than non-cancerous subjects.

This retrospective study in CHU Amiens is searching on the number of side effects of NTM treatment in two groups (cancerous and no cancerous) to assess the cause of the decrease of NTM treatment in cancerous patients.


Eligibility Criteria:
Inclusion Criteria:

* Age equal or more than 18 years18
* Patients diagnosed by an infection with non-tuberculous mycobacteria according to ATS guidelines.
* Patients received the NTM treatment.

Exclusion Criteria:

* age less than 18 years
* Patients diagnosed by NTM without treatment.
* Patients with a positive sample of NTM but without infection.
* Exclusion of other disorders such as tuberculous.
Investigation of Kava Effects on NNK Metabolism

This is a non-therapeutic, single-arm pilot clinical trial in adult healthy smokers to assess whether kava can alter NNK metabolism in humans.


Eligibility Criteria:
Inclusion Criteria:

* Adult ≥ 18 years
* Current smoker of ≥ 5 cigarettes daily, determined by self-report
* Adequate liver and kidney function, defined as:

  * Bilirubin, alkaline phosphatase, ALT, and AST within normal limits
  * Creatinine \<1.2
* Adequate hemoglobin, defined as a hemoglobin ≥12 mg/dL for men and ≥11 for women.
* Ability and willingness to abstain from all medication and dietary supplements for 3 days prior to kava administration, continuing until a minimum of 7 days after kava administration. Topical medications and inhaled medications that do not contain steroids are permitted.
* Ability and willingness to completely abstain from alcohol consumption for 3 days prior to kava administration, continuing until a minimum of 7 days after kava administration
* Ability to understand the investigational nature of the study and provide informed consent
* Willingness to take kava supplement as instructed

Exclusion Criteria:

* Known hepatobiliary disease or impairment
* History of gastric bypass surgery, gastric banding, bowel resection, malabsorption syndromes such as celiac sprue or pancreatic insufficiency, or other conditions that may affect the absorption of kava
* Chronic medication use that cannot be safely stopped
* Use of tobacco products other than cigarettes (i.e. snuff, snuz, smokeless tobacco, cigars, pipes)
* Major or chronic medical medical disease, including heart disease, poorly controlled diabetes, etc., to be adjudicated by the principal investigator
* Women who are pregnant, intend to become pregnant within 3 months of the study period, or who are breastfeeding
* Current or recent (within 12 months) problems with drug use or alcohol dependence by self-report
* Antibiotic use within 2 months of study enrollment by self-report
* Alcohol dependence, abuse, or history of dependence/abuse by self-report
Video Documented PBS-Score in Children With Clubfoot

Evaluate agreement and inter-rater reliability of PBS-score assessments based on video documented material.

120 children with idiopathic clubfoot will be included from four different countries 30 patients from each participating center. Inclusion criteria include: age 4-14 years, diagnosis of idiopathic clubfoot, ability to walk 10 m repeatedly, and ability to communicate verbally (and in writing for caregivers) in Swedish, English, Portuguese, Urdu, or Pashto. All items of the PBS-score will be documented using video recordings. Six to eight senior orthopedic surgeons will score a total of 90 children each, not the children from their center of employment, according to the PBS-score based on videos. Collaborating centers include Karolinska University Hospital, Sweden, Hospital Pequeno Príncipe, Brazil, and Hayatabad Medical Complex, Orthopaedic Unit, Peshawar, Pakistan.

Eligibility Criteria:
Inclusion Criteria:

* Clubfoot

Exclusion Criteria:

-
Complex EVAR in Inflammatory and Infective Abdominal and Thoracoabdominal Aortic Aneurysms

Complex endovascular aortic repair in inflammatory and infective perivisceral abdominal aortic aneurysms and thoracoabdominal aortic aneurysms (CEVARII) study is a collaborative international effort among vascular surgeons to establish a database on the global experience in the management of INAAs and IAAs. Ethical approval for the study was obtained from the Colorado Multiple Institutional Review Board (COMIRB) under protocol number 23-1533.

Infective Native and Inflammatory Aortic Aneurysms (INAA \& IAA) are rare, morbid conditions with unique challenges. INAA \& IAA share clinical and imaging similarities but differ significantly in pathophysiology, management, and prognosis. Open surgical repair of INAA \& IAA is technically challenging and associated with higher complications.

Complex endovascular aortic repair in inflammatory and infective perivisceral abdominal aortic aneurysms and thoracoabdominal aortic aneurysms (CEVARII) study is a collaborative international consortium effort among vascular surgeons to establish a database on the global experience in the management of INAAs and IAAs. CEVARII study is IRB approved with the number 23-1533.

Knowledge gained will help generate consensus on how to best manage patients with inflammatory and infective aortic aneurysms involving the visceral and thoracoabdominal aorta.

Eligibility Criteria:
Inclusion Criteria:

Patients aged ≥ 18 years old with a diagnosis of inflammatory abdominal aortic aneurysm (IAA) or infective native aortic aneurysms (INAA), who have undergone complex endovascular aortic repair (cEVAR) are eligible for inclusion in this study.

Exclusion Criteria:

* Suboptimal documentation of clinical, laboratory, and imaging findings
* Presence of prosthetic material (endograft or open graft material)
* Prior open or endovascular aortic repair
* Findings suspicious of secondary aorto-enteric or -bronchial fistulas.
The Effect of Patient-Controlled TEAS vs Sham TEAS for Improve Quality of Life in Patients With Cancer Pain

The conduct of a pilot trial is of great significance as a means of assessing the feasibility and harmonization of the research and is a very necessary precursor to the better conduct of formal trials. The primary aim of this pilot study is to assess the feasibility of a PC-TEAS in improving the quality of life of cancer patients with pain, with the aspiration of providing process evidence base and an assessment of the intervention for conducting a formal trial. the secondary outcome is to assess the clinical efficacy of the PC-TEAS.


Eligibility Criteria:
Participants who had been diagnosed with cancer pain were eligible if they ①were 18 to 75 years old, ②had NRS pain score of ≥4 in the previous 1 week, or had regular use of analgesics, ③ anticipated survival of at least 6 months, ④ECOG-PS score ≤2 points, ⑤stable vital signs, clear consciousness, and the ability to correctly judge their pain, communication is unhindered, able to cooperate with researchers to complete relevant research assessments, ⑥voluntarily participate in this study and sign the informed consent form. Exclusion criteria included the following: ①Have venous thrombosis of the upper and lower limbs (below the elbow/knee joint), active cerebrovascular disease, severe cardiopulmonary dysfunction, or patient is clinically unstable (eg, acute infections, electrolyte disturbances).②Patients with pacemaker implantation or metal implantation in the body. ③People with local skin at acupoints lesions, poor skin conditions, or other people unsuitable for PC-TEAS treatment. ④Cancer patients who are planning to become pregnant recently or are pregnant. ⑤Have a psychiatric disorder or severe cognitive impairment who are unable to communicate. ⑥Participating in other clinical trials.
Quantitation of Bacteria Associated With Severe Periodontitis by Real -Time PCR Following Application of Diode Laser

1. Primary objective To measure the gingival crevicular levels of A.actinomycetemcomitans and P.gingivalis after intra-pocket application of diode laser in severe periodontitis (stage 3 grade C) patients.
2. Secondary objective To compare the levels of the same microorganisms as in cases of diode laser therapy to those after conventional treatment with systemic antibiotic administration in severe periodontitis (stage 3 grade C) patients.
3. to measure clinical parameters probing depth,attachment loss and mobility grade


Eligibility Criteria:
Inclusion Criteria:

1. Patients of both sexes having severe periodontitis (stage 3 grade C) with interdental clinical attachment loss (CAL) ≥ 5.
2. Patients' age between 15 and 35 years old with rapid bone loss showed by radiograph.
3. Systemically healthy patients.
4. Radiographic bone loss extending to middle or apical third of root.
5. Probing depth (PD) ≥ 6 mm.

Exclusion Criteria:

1. Use of antibiotics during the last 3 months.
2. Pregnancy.
3. Any systemic condition that might affect the study.
4. Use of mouthwash containing antimicrobials during the previous 3 weeks.
5. Smoking.
Laparoscopic Cholecystectomy or Conservative Treatment in the Acute Cholecystitis of Elderly Patients

Cholecystectomy is the only curative treatment for gallstone disease of acute calculous cholecystitis.The purpose of this study is to find the most effective treatment (laparoscopic cholecystectomy vs. conservative) for elderly patients with acute cholecystitis. Therefore a randomized multi-centre study of 200 elderly patients suffering from acute cholecystitis is performed with additional cohort of all elderly patients with acute cholecystitis in the study hospitals during study period.

The increasing age is one of the main risk factors for developing complicated gallstone disease. Currently, there is lack of good quality studies comparing risks and benefits of early laparoscopic cholecystectomy in the elderly patients. Cholecystectomy is the only curative treatment for gallstone disease of acute calculous cholecystitis.

Aim: The purpose is to find out the most effective treatment (laparoscopic cholecystectomy vs. conservative) with the least morbidity for elderly patients with acute cholecystitis.

Study design: multicenter randomized controlled trial (RCT) and additional cohort of all elderly patients (\>75 years old) with acute cholecystitis.

Patient allocation: Elderly patients with diagnosis of acute cholecystitis will be randomly allocated to either early laparoscopic cholecystectomy or treatment with antibiotics. Reasonably healthy elderly patients (ASA 2-3) are included in this study, excluding the patients with ASA-class above 4.

Interventions: The study group of patients will undergo early laparoscopic cholecystectomy within 48 hours after hospitalization. The control group will be managed conservatively with intravenous antibiotics and elective cholecystectomy will not be scheduled later.

Primary outcome: Assessment of morbidities related to acute cholecystitis and individual quality of life. Secondary outcomes include number of hospital admissions, length of hospitalization, pain, complications, mortality and cost analysis.

Sample size and data-analysis: Based on data of previous studies the recruitment of 200 patients in total is expected. Follow-up will be for 12 months.

In addition of RCT, we decided to record and analyze all acute cholecystitis of elderly patients in study hospitals during the study period. We will present these results in the connection of RCT analysis.

Eligibility Criteria:
Inclusion Criteria:

* Radiologically confirmed acute cholecystitis
* Age over 75 yrs
* American Association of Anesthesiologists Classification class 2-3
* Duration of symptoms \< 5 days

Exclusion Criteria:

* American Association of Anesthesiologists Classification class 4-5
* Age under 75 yrs
* Peritonitis
* Sepsis or septic shock
* Duration of symptoms over 6 days
* Cholestasis or diagnosed stone at common biliary duct.
* Acute Pancreatitis
Flexibility, Range of Motion and Strength Among Patients With Differing Response to the Scapular and Humeral Assistance Tests

Shoulder pain may result from abnormal arm or shoulder blade (scapular) movement. These abnormal movements may result from a variety of flexibilty, motion or strength impairments. Therefore identifying any abnormal arm or scapular movement, as well as any impairments that are associated with them can help clinicians plan a proper management strategy for patients presenting with shoulder disorders. Our hypothesis is that specific impairments will be associated with abnormal arm movement, while other impairments will be associated with abnormal scapular movement among patients with shoulder pain.


Eligibility Criteria:
Inclusion Criteria:

* Age 18 years or older, main complaint of shoulder pain, ability to elevate arm in the scapular plane to at least 135 degrees, pain during scapular plane elevation, can read Hebrew.

Exclusion Criteria:

* Signs or symptoms suggesting cervical spine origin, previous fracture around shoulder complex, traumatic onset of shoulder pain, Fibromyalgia, Rheumatiod arthritis, previous shoulder surgery, loss of 50% or more of passive range of motion in 2 or more planes of motion, positive lag signs, positive apprehension test, pregnancy.
Eval EarlySense Bet Lowenstein Sleeplab

The study objective is to collect heart rate, respiration rate and motion data of patients admitted to sleep lab and to determine the accuracy level of the EarlySense system vs. the monitors used in sleep lab (e.g., Polysomnography, respiratory belts, ECG, etc..) . Data regarding sleep condition, scoring and quality of sleep and in and out of bed status, patient turns will also be collected and compared to data collected by EarlySense contactless monitor. Different patient population will be monitored including obese, morbidly obese, patients with or without obstructive/central apnea, patients with or without arrhythmia as well as healthy population who arrive to sleep lab for general evaluation will be monitored

EarlySense sensors will be placed under the mattress of subjects who have been included in the study. The sensors will not be in any contact with the patient. Two sensors will be utilized and placed under the subject's chest and pelvis area. Accuracy of the sensors will be compared to each other and to the reference device.

Eligibility Criteria:
Inclusion Criteria:

1. Age 18 years or above
2. Is willing to sign the consent form

Exclusion Criteria:

1. Age \< 18 years
2. Is not willing to sign the consent form
The Effects of Homogenized and Unhomogenized Milk on Postprandial Metabolism in Healthy Overweight Men

The purpose of this study is to compare the effects of homogenized, unhomogenized and skimmed milk on postprandial metabolism in healthy overweight men


Eligibility Criteria:
Inclusion Criteria:

* men
* aged between 18 and 70 years
* Quetelet index between 25 - 30 kg/m2
* mean serum triacylglycerol (≤1.7 mmol/L (31))

Exclusion Criteria:

* women
* indication for treatment with cholesterol-lowering drugs according to the Dutch Cholesterol Consensus (32)
* lactose intolerance
* current smoker
* familial hypercholesterolemia
* abuse of drugs
* more than 21 alcoholic consumptions per week
* no stable body weight (weight gain or loss \< 3 kg in the past three months)
* use of medication or a diet known to affect serum lipid or glucose metabolism
* severe medical conditions that might interfere with the study, such as epilepsy, asthma, chronic obstructive pulmonary disease, inflammatory bowel diseases and rheumatoid arthritis.
* active cardiovascular disease like congestive heart failure or recent (\<6 months) event (acute myocardial infarction, cerebro vascular accident)
* use of an investigational product within the previous 1 month
* not willing to stop the consumption of vitamin supplements, fish oil capsules or products rich in plant stanol or sterol esters 3 weeks before the start of the study
* not willing to give up being a blood donor (or having donated blood) from 8 weeks before the start of the study and during the study
* difficult venipuncture as evidenced during the screening visits
Clinical Trial to Examine Effectiveness of a Human Allograft for Treatment of DFU and VLU

Retrospective clinical study of 188 patients to examine effectiveness of human cryopreserved allograft in the treatment of diabetic foot ulcers and venous leg ulcers

Retrospective Observational study of 188 consecutive patients to examine the efficacy of biologically active cryopreserved human skin allograft (Theraskin) on the treatment of diabetic foot ulcers and venous leg ulcers

Eligibility Criteria:
Inclusion Criteria:

1. Theraskin applied to lower extremity wound during the study period.
2. Over 18 years of age.
3. Males and Females.
4. lower Extremity wound due to diabetic neuropathy or venous insufficiency.
5. Documented palpable pedal pulse (dorsalis pedis and/or posterior tibialis arteries and/or palpable bypass graft), or ankle brachial index (ABI) in the range of \> 0.8 to \< 1.1 or Tcpo2 \> 40 mm Hg from the foot at the time of the initial allograft applicaton
6. In subjects with multiple wounds only the largest wound receiving the allograft was included and considered the target wound
7. Initial wound size \>1 cm 2
8. All wound locations within the lower extremity (defined as below the knee) and wound durations included
9. Concomitant Negative pressure wound therapy was allowed as this could have been an anchoring technique for the allograft
10. Concomitant antibiotics ( topical, oral, or intravenous) were allowed as it was not possible to determine whether administration of antibiotics was due to a true infection at the target wound site.

Exclusion Criteria:

1. Wound etiologies other than diabetic neuropathy or nevous such as trauma, burns, sickle cell anemia, necrobiosis lipoidica , pyoderma gangrenosum.
2. Wound not present for at least 30 days and showing lack of progression for at least 30 days prior to application of Theraskin.
3. Other ulcer treatments besides study allograft during the study period ( study period definition: time of first allograft application up to 20 weeks) were not included in this study. These concomitant treatments specifically include hyperbaric oxygen treatments, venous ablation procedures, revascularization procedures including lower extremity bypass grafts or angioplasties or stents, application of additional growth factors, biologic products containing cells or other tissue-derived products, matrix components, or enzymatic debriders. Subjects were allowed to receive standard of care therapy with the study allograft, which included debridement, moist dressings or compression dressings depending on wound etiology, and off-weighting depending on wound location.
4. Patients with revascularization procedures (defined as lower extremity bypass grafts, angioplasties, or stents) within 30 days of initial TheraSkin application were excluded
5. Patients with successful surgical correction or intervention aimed at improving venous return in the target limb, such as venous ablation procedures, within 30 days of initial TheraSkin application were excluded