cyrilzakka/clinical-trials huggingface dataset:
A Multicenter Real-world Study of Screening of Cervical Cancer Based on Photoelectric Detection

The main purpose of this study is to explore the accuracy and clinical value of fluorescent photoelectric cervical lesion image detector as a screening and shunt tool for cervical lesions through a multi-center, large-sample real-world study with histopathology as the gold standard. The secondary purpose of the study was to verify the coincidence of the fluorescent photoelectric cervical lesion image detector with traditional colposcopic chemical staining.

This study is expected to include 20,000 participants with definite histological results, and compare the specificity and sensitivity, negative predictive value and positive predictive value of three cervical lesion screening methods, such as fluorescent photoelectric cervical lesion image detector, HPV nucleic acid detection and cytology detection. The advantages and disadvantages of fluorescent photoelectric cervical disease image detector, HPV nucleic acid detection and cytology examination were analyzed, and their application scenarios were provided to provide evidence-based medical support for the establishment of comprehensive prevention and treatment system of cervical cancer suitable for China's national conditions.


Eligibility Criteria:
Inclusion Criteria:

* 1. Age ≥ 18 years old, ≤ 65 years old, with a complete cervix without deformity.
* 2. Have clear cervical cancer screening results, meet HPV16/18 (+) or high-risk HPV (+), and cervical cytology results ≥ ASC-US.
* 3. Fully informed and agreed to participate in the study.
* 4. No history of cervical cancer disease and cancer in other parts.

Exclusion Criteria:

* 1. Cannot meet all Inclusion Criteria.
* 2. There is clear immunosuppression, such as HIV infection or organ transplantation, etc., and the vagina or cervix is in the acute inflammation stage。
* 3. There are serious bleeding diseases or photosensitive diseases such as abnormal coagulation.
Evaluation of a Food Supplement on Sleep Quality

The purpose of this study is to evaluate the efficacy on sleep quality of a food supplement.


Eligibility Criteria:
Inclusion Criteria:

* Healthy volunteer aged between 25 to 65 years
* Patient diagnosed for primary Insomnia (threshold for inclusion: 10 on the ISI scale)
* Healthy volunteer without diurnal sleep (total score for inclusion must be less than 10 on the Epworth scale)
* Patient affiliated to the French Social Security
* Patient who gave written informed consent

Exclusion Criteria:

* Secondary insomnia
* History of severe psychiatric disorder, assessed by the MINI test
* Resistance to Hypnotic drugs
* Anxiety, depression, suicide, detected by the Beck Depression Inventory
* Acute Pathology during the precedent three years
* Breast feeding and pregnancy women
* Non compliant volunteer
* Hypersensibility to treatment composant
Rivaroxaban Post-Transradial Access for the Prevention of Radial Artery Occlusion (CAPITAL-RAPTOR)

Transradial access (TRA) is the preferred vascular access site for invasive coronary angiography. TRA is limited by blockage of the radial artery post-procedurally, preventing future use of TRA. This is referred to as radial artery occlusion (RAO) and occurs in \~5% of cases. While intraprocedural anticoagulation has been studied extensively to mitigate this complication, oral anticoagulation post-TRA has not. The investigators will assess the impact of a one-week course of rivaroxaban post-TRA to reduce the rate of ultrasound-defined RAO at 30 days.


Eligibility Criteria:
Inclusion Criteria

* Willing and able to provide written informed consent
* Age ≥ 18 years
* Diagnostic coronary angiography/left heart catheterization or percutaneous coronary intervention via the transradial approach

Exclusion Criteria

* Presence of a palpable hematoma or clinical concern of hemostasis at the transradial access site in which bleeding risk would be prohibitive
* Access or attempted access site - including contralateral radial artery, brachial artery, or femoral artery or vein as switching of access could be attributed to arterial injury
* Planned staged procedure, coronary artery bypass grafting or noncardiac surgery, within 30 days
* Pregnant or lactating females
* Contraindication or high risk of bleeding with anticoagulation

  1. bleeding requiring medical attention in the previous 6 months
  2. thrombocytopenia (platelets\<50 x 109/L)
  3. any prior intracranial hemorrhage
  4. use of glycoprotein IIb/IIIa inhibitors during percutaneous coronary intervention
  5. administration of thrombolytic therapy in the preceding 24 hours
  6. use of regular non-steroidal anti-inflammatory medications excluding Aspirin \<100mg/day
  7. ischemic stroke or transient ischemic attack diagnosed in the last 3 months
* Cardiogenic shock
* Ventricular arrhythmias refractory to treatment
* Liver dysfunction (Child-Pugh class B or C)
* Unexplained anemia with a Hgb below 100 g/L
* History of medication noncompliance or risk factor for noncompliance
* Active malignancy
* Allergy to rivaroxaban
* Another indication for anticoagulation
* Strong CYP3A4 and P-glycoprotein inhibitor use which increase rivaroxaban levels (ketoconazole, itraconazole, lopinavir/ritonavir, ritonavir, diltiazem, verapamil and conivaptan, carbamazepine, phenytoin, rifampin, St.John's wort)
* Life expectancy \<30 days
* Women capable of pregnancy not on birth control
* Chronic kidney disease with creatinine clearance of less than 30mL/min
* History of antiphospholipid syndrome, in particular triple positive (lupus anticoagulant, anticardiolipin antibodies, and anti-beta 2-glycoprotein I antibodies)
A 16 Week Study Evaluating Levetiracetam in the Treatment of Post Herpetic Neuralgia (PHN)

16 week trial assessing the efficacy, safety, and tolerability of levetiracetam compared with placebo in the treatment of postherpetic neuralgia.


Eligibility Criteria:
Inclusion Criteria:

* male or female outpatient greater than or equal to 18 years of age.
* suffering presently from neuralgia, which has been present for at least 3 months since healing of acute herpes zoster skin rash.
* PHN pain at entry into the study must meet the following criteria: a VAS of at least 40 mm at visit 2 (to assess pain intensity during the past week) and with an average daily score of at least 4 on the PIS during the baseline period as evaluated on a minimum of 4 days.
* an estimated creatinine clearance of at least 50 ml/min.

Exclusion Criteria:

* receiving professional psychological support (such as cognitive behavioral therapy) currently or within 2 weeks prior to visit 1 specifically for coping with PHN.
* previous neurolytic or neurosurgical therapy for PHN, at any time in the subject's history or treatment with TENS (transelectroneuro stimulation) currently or within the past 2 weeks.
* known co-existent source of pain or painful peripheral neuropathy.
* known significant neurological disorder other than the study disease or a condition which can mimic stroke with distal neurological deficit (amyotrophy, radiculopathy, history of TIAs, multiple sclerosis, or any amputations).
* conditions known to be associated with immunosuppressive states.
* clinically significant major depression defined as a Beck Depression Inventory Score \> 21 at selection including those with a history of Bipolar Disorder.
Transitional EPRO Diary Liver

The study is part of the MACROLIVER Project, whose main objective is to create a digital tool for patients and caregivers for the management of liver disease that allows the optimization of therapy and/or the treatment process, even remotely. Such a tool not only reduces the movement of patients who are by definition fragile, but also enables the optimization of access and care by a multidisciplinary team. This tool is intended to support doctors and patients, but in no way replaces normal clinical practice. This study aims to explore the specificities of patients experiencing the transition from the pediatric ward to the adult ward in order to identify risk and protective factors that influence psychological well-being at both an individual and relational level. In order to gather all the information about the patients attending the transitional clinic and to obtain a more complete and truthful clinical-psychological picture, the study also includes the collection of retrospective data of the transplanted patients.


Eligibility Criteria:
Inclusion Criteria:

* patients between the ages of 14 and 20 who have been transplanted at the ASST-PG23 transplant center or are awaiting a liver transplant and belong to the transition to adult services
* signed informed consent
* proven use of the APPs (to be assessed based on the last 2 weeks)

Exclusion Criteria:

-
Impact of Active Breathing Exercises on Respiratory Rhythm Disorders in Stroke Patients

The goal of this clinical trial is to explore The Effect of Active Breathing Exercises in Stroke Patients With Respiratory Rhythm Disorder. Patients will be randomly divided into an observation group and a control group, all receiving routine rehabilitation treatment. On this basis, the observation group will be given Active Breathing Exercises. Researchers will compare dysphagia of two groups.

A growing body of literature indicates the existence of a highly stable, coordinative relation between respiration and oropharyngeal swallowing in healthy adults. The goal of this clinical trial is to explore The Effect of Active Breathing Exercises in Stroke Patients With Respiratory Rhythm Disorder. Patients will be randomly divided into an observation group and a control group, all receiving routine rehabilitation treatment. On this basis, the observation group will be given Active Breathing Exercises. Researchers will compare dysphagia of two groups.

Eligibility Criteria:
Inclusion Criteria:

* diagnosed with Respiratory Rhythm Disorder
* age ≥ 18 years;
* meeting the diagnostic criteria of stroke;
* any degree of dysphagia at admission;
* steady vital signs, without severe cognitive impairment or sensory aphasia, able to cooperate with the assessment.
* transferred out within three weeks of hospitalization in the neurology department.

Exclusion Criteria:

* complicated with other neurological diseases;
* tracheostomy tube plugged;
* unfeasible to the support of parenteral nutrition;
* simultaneously suffering from liver, kidney failure, tumors, or hematological diseases.
Transfusion in Lower Risk MDS Patients: Predictors of Adequacy of Transfusion and Quality of Life in Lower Risk MDS

Observational study to evaluate changes in quality of life (QoL) in patients diagnosed with low risk MDS who are red blood cell (abc) transfusion dependent.

Changes in QoL will be correlated with patient cardiorespiratory function. Cardiac biomarkers and plasma cytokines will also be evaluated.

At inclusion and before red blood cell (rbc) transfusion, patients cardiorespiratory function will be evaluated with an ergospirometer

Likewise, before and after rbc transfusion, patients will be asked to complete the QUALMS, a QoL instrument which will be supplied by Dr. Gregory Abel at Dana-Farber in the U.S., who led its development team.

Before and after rbc transfusion, hemoglobin, pretrasfusional hemoglobin, pre and post cardiac biomarkers troponin and NTproBNP will be collect.Pre and post serum and plasma will also be collected for cytokine analysis.

Eligibility Criteria:
Subjects must meet all of the following inclusion criteria:

1. They must be able to understand the study procedures, comply with them, and consent in writing prior to any specific study procedure.
2. Must be able to understand the study procedures, comply with them, and give written informed consent prior to any study-specific procedure.
3. Adult subjects ≥ 18 years of age with a diagnosis of myelodysplastic syndrome.
4. Very low, low or intermediate IPSS-R risk category.
5. Subject requires are red blood cell transfusion dependent with the following criteria: requires an average of 2 to 6 units of CH on average over an 8-week period.
6. ECOG 0-3.

Exclusion criteria

1. Subject undergoing any of the following treatments: azacitidine, decitabine, venetoclax, cytotoxic chemotherapy, radiotherapy, arsenic trioxide, interferon or interleukin.
2. High or very high IPSS-R risk category.
3. Subject diagnosed with any active neoplasm except:

   * epidermoid or basal cell carcinoma,
   * carcinoma in situ of the uterine cervix
   * Carcinoma in situ of the breast
4. Subjects with a score on the New York Heart Association Scale IV.
5. Subjects with major surgery within 8 weeks prior to study inclusion. Subjects must have fully recovered from any previous surgery prior to inclusion in the study.
6. Subject with known clinically significant anaemia due to iron, vitamin B12 or folate deficiencies or autoimmune or hereditary haemolytic anaemia or uncontrolled hypothyroidism or known clinically significant haemorrhage or sequestration or subject with drug induced anaemia.
7. New onset or uncontrolled seizures.
8. Subjects with uncontrolled systemic fungal, bacterial or viral infections (defined as ongoing signs or symptoms related to the infection without improvement despite appropriate antibiotics or antimicrobial therapy).
9. Pregnant or breastfeeding women.
10. The subject has any condition, including the presence of laboratory abnormalities that would place the subject at unacceptable risk if he/she were to participate in the study.
11. The subject has any condition or receives concomitant medication that confounds the ability to interpret the study data.
Feasibility Study of Novel Prescription Digital Therapeutic Supporting Unobserved Buprenorphine Initiation & Adherence

The purpose of this study is to assess feasibility of an at-home digital therapy designed to support buprenorphine initiation and adherence.

The purpose of this study is to develop and evaluate the acceptability of a novel feature for use with the prescription digital therapeutic reSET-O.

This feature aims to improve the quality of treatment for opioid use disorder (OUD) patients starting buprenorphine initiation at home by providing new digital content and withdrawal symptom assessment to support them during this process.

This study will evaluate the acceptability of this new feature and assess success of at-home buprenorphine initiation.

Eligibility Criteria:
Inclusion Criteria:

1. Provide written informed consent prior to any study specific assessments being performed
2. Male or female ≥18 years of age, inclusive
3. English proficiency to meaningfully participate in consent process, assessment and intervention
4. Meets clinical sites criteria for buprenorphine initiation (e.g. current opioid use)
5. Currently receiving buprenorphine outpatient treatment for OUD (Part 1) or wishing to start buprenorphine treatment
6. Capable of using common software applications on an internet-enabled mobile device (smart phone or tablet)
7. Interested in testing or using PEAR-002b
8. No prior history of reSET-O use
9. Has not participated in any other investigational drug trials within the past 30 days (or within 5 half-lives of study drug, whichever is longer) of enrollment
10. Is considered appropriate for participation by their clinician

Exclusion Criteria:

1. Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) diagnosis of OUD and on methadone or naltrexone pharmacotherapy
2. DSM-5 diagnosis of OUD and already on buprenorphine
3. Planning to move out of the geographic area within 2 months
4. Unable to use English to participate in the consent process, the interventions, or assessments
5. Inability to comply with study procedures, due to severe medical conditions or otherwise
6. Currently receiving inpatient treatment for OUD
7. Women who are pregnant
Genetics of Reproductive Disorders (Including Kallmann Syndrome) and Cleft Lip and/or Palate

The purpose of this study is to explore the genetic basis of reproductive disorders and cleft lip and/or palate.

The World Health Organization estimates approximately 10% of couples experience some sort of infertility problem.

In humans, puberty is the process through which we develop reproductive capacity.

The timing of puberty varies greatly in the general population and is influenced by both genetic and environmental factors. In extreme cases of pubertal delay, puberty progresses only partially or not at all and results in the clinical picture of congenital hypogonadotropic hypogonadism (CHH), either accompanied by anosmia in 50% of cases (Kallmann syndrome \[KS\]) or by normal sense of smell (nCHH), with a male: female ratio of 4:1.

CHH is due to GnRH deficiency (incidence 1: 4,000-10,000) and result in the failure of sexual maturation and infertility. It is genetically heterogeneous, with multiple patterns of inheritance and several associated loci. In the clinical spectrum of GnRH deficiency, CHH may also be associated with a cleft lip/palate (CL/P) in 5 to 7% of cases. However, this prevalence increases up to 40% in CHH patients carrying a mutation in a CL/P gene, suggesting a genetic overlap between CHH and CL/P.

Disorders of puberty have provided insight into the biology of reproduction and genetic technologies have enabled us to deepen understanding in this field. The focus of this study is to better understand the genetic control of puberty and human reproduction as well as its link with CL/P.

Increasing understanding of the molecular basis (genes) of inherited reproductive disorders and CL/P may enable investigators to:

* improve diagnostic testing and treatments for these problems
* develop new diagnostic tests and therapies for patients
* enhance counseling for patients and families with reproductive disorders
* enhance counseling for patients and families with cleft lip/palate

Eligibility Criteria:
Inclusion Criteria:(any of the following conditions)

* hypogonadotropic hypogonadism
* Kallmann syndrome
* adult-onset hypogonadotropic hypogonadism
* hypothalamic amenorrhea
* polycystic ovarian syndrome
* primary gonadal failure
* precocious puberty
* cleft lip/palate
* family members of the above groups

Exclusion Criteria:

* acute illness/hospitalization
* pituitary tumors
* iron overload (hemochromatosis)
* infiltrative diseases (sarcoidosis)
* chronic alcohol abuse
* illicit drug use
* anabolic steroid abuse
Rituximab Therapy for Steroid-Refractory Chronic Graft Versus Host Disease

The purpose of this study is to determine if rituximab is a safe and effective therapy for steroid-refractory chronic graft versus host disease (GVHD).

Patients will receive rituximab intravenously one time per week for four consecutive weeks. Once therapy is completed, the patient will have weekly visits with their physician for four more weeks, at which they will complete a simple questionnaire designed to evaluate the severity of chronic graft versus host disease.

At the end of the eighth week on the study (4 weeks of study treatment and 4 weeks of observation), patients will be evaluated to determine whether their chronic graft versus host disease (GVHD) has resolved.

If chronic graft versus host disease has resolved entirely, the patient will be monitored for the remainder of the year.

If after the initial eight weeks on the study the patient still has symptoms or signs of GVHD, they may receive a second four week study treatment.

If the patients' chronic GVHD reappears after receiving either one or two courses of rituximab, a third and final four week course of medication can be given provided it has been at least eight weeks since the last dose.

Blood tests will be performed at the beginning of the study, after 8 weeks on the study, after 16 weeks on the study and at the end of 1 year.

Eligibility Criteria:
Inclusion Criteria:

* Recipients of matched related, matched unrelated, or mismatched stem cell transplantation
* At least 180 days since allogeneic stem cell transplantation procedure
* Patients must have steroid-refractory chronic GVHD, defined as having persistent signs and symptoms despite the use of prednisone
* Stable dose of corticosteroids for 4 weeks prior to enrollment
* Adequate bone marrow function: absolute neutrophil count (ANC) \> 500/mm; platelets \> 20,000 ul
* Adequate renal function: creatinine \< 3.0 mg/dl
* Adequate hepatic function: bilirubin \< 3.0 mg/dl; AST \< 90 IU

Exclusion Criteria:

* Prednisone requirement greater than 2 mg/kg/day or equivalent
* Known life-threatening sensitivity to rituximab or other anti-B cell antibody.
* Prior exposure to any new immunosuppressive medication in the preceding 4 weeks prior to enrollment.
* Active, uncontrolled infection
* Evidence of natural exposure to hepatitis B or C.
* Active malignant disease relapse
* Donor lymphocyte infusion within the preceding 100 days.
* Life expectancy of less than 3 months.
* Pregnancy or lactation
* Evidence of HIV seropositivity
Who and Why do Patients Report Lymphedema After Breast Cancer Treatment Without an Objective Measurable Swelling

Breast cancer related lymphedema (BCRL) at the arm and/or trunk is an extremely dreaded complication after breast cancer treatment due to its chronicity and impact.

The incidence of objective arm and trunk/ breast BCRL is declining due to the major shift into the treatment approach of breast cancer. However, many patients report a sensation of swelling without the presence of objective BCRL, referred to as subjective BCRL. Therefore, subjective BCRL is defined as the diagnosis of BCRL based on the patient's sensation of a difference in size at the arm and/or trunk without the presence of objective BCRL.

At this moment, there is no clear information on the prevalence and the transitions between different BCRL states (no-subjective-objective) over time, as well as about the underlying mechanisms and contributing factors of subjective BCRL. Therefore, the investigators hypothesize that four mechanisms might be associated with the presence and severity of subjective arm or trunk/breast BCRL, including the presence and/ or severity of lymphatic (1) and sensory processing problems (nociceptive (2), neuropathic (3), and/or central sensory processing problems (4)).

The investigators will set up a prospective longitudinal study with breast cancer patients to determine the prevalence of subjective and objective arm or trunk/ breast BCRL at 1, 6, and 12 month(s) post-surgery and the transitions between different BCRL states (no-subjective-objective BCRL) (AIM 1). In addition, factors related to four potential underlying mechanisms (lymphatic, nociceptive, neuropathic, and central sensory processing problems) that contribute to the occurrence of subjective BCRL in comparison to no self-reported swelling and objective BCRL will be determined (AIM 2). Furthermore, the present study will be undertaken to determine factors related to these four underlying mechanisms that contribute to the severity of subjective BCRL at arm or trunk/ breast BCRL within the group of patients with subjective BCRL at different time-points after surgery (at 1, 6, and 12 month(s) post-surgery) (AIM 3).


Eligibility Criteria:
Inclusion criteria:

1. adults (men and women) who are ≥ 18 years of age
2. diagnosed with primary unilateral non-metastatic or oligometastatic breast cancer
3. scheduled for surgery (mastectomy or breast conserving surgery; in combination with axillary lymph node dissection or sentinel node biopsy)
4. able to read, understand, and speak Dutch
5. have voluntary written informed consent of the patient

Exclusion Criteria:

1. distant metastases
2. planned bilateral lymph node surgery
3. oedema of the arm from another cause
4. an allergy to iodine or Indocyanine Green (ICG), or
5. physically or mentally unable to participate throughout the entire duration of the study