cyrilzakka/clinical-trials huggingface dataset:
Impact of Obstructive Sleep Apnea (OSA) Treatment on Blood Pressure Control in Chronic Kidney Disease

The role of obstructive sleep apnea (OSA) on chronic kidney disease (CKD) is not clear. This randomized clinical trial will test the impact of OSA treatment on blood pressure (BP) and on the estimated glomerular filtration rate (eGFR) in patients with CKD IIIb and IV (eGFR 44-15 ml/min). A polygraph will be performed to assess the presence of OSA (defined by an apnea-hypopnea index ≥15 events/hour). Patients with OSA will be randomized to use continuous positive upper airway pressure (CPAP) or to maintain optimized clinical treatment for BP control. Antihypertensive medication adjustments will be allowed using a standard protocol for both groups by the same researcher, who will not have access to CPAP follow-up. In addition to clinical (including BP and ambulatory BP monitoring, ABPM) and laboratory assessments at baseline, we will follow up at 3 months, 6 months, 9 months and 12 months after randomization of the proposed outcomes. Target organ damage analyses, such as the retina and echocardiography, will be performed at baseline and after 1 year of randomization. Primary objective: to compare the effect of CPAP on the need to adjust antihypertensive medication to control systolic BP (\<130mmHg) in patients with CKD; secondary objectives: 1) to evaluate the reduction in systolic and diastolic BP by office and ABPM; 2) assessment of nocturnal BP dipping; 3) to evaluate the impact of OSA treatment with CPAP on eGFR during follow-up; 4) to evaluate the impact of OSA treatment with CPAP on the evolution of albuminuria; 5) assessment of other target organ damage such as retinopathy and cardiac remodeling; 6) to evaluate the impact of OSA treatment with CPAP on the possible delay for renal replacement therapy or end-stage renal disease (eGFR \<15ml/min and dialysis); 7) to evaluate the impact of OSA treatment with CPAP on the quality of life of patients with CKD. With a significance level of 5% and study power of 90%, two-tailed hypothesis testing, 74 patients with OSA per group, i.e., 148 patients in total, will be required to assess the primary endpoint (we estimate that 25% and 50% of patients in control and CPAP groups will not need to adjust their antihypertensive medication at follow-up, respectively).


Eligibility Criteria:
Inclusion Criteria:

* Confirmed diagnosis of hypertension: Use of oral antihypertensive drugs or systolic BP (SBP) \>140 mmHg and/or diastolic BP (DBP) \>90 mmHg on 2 office measurements or \>130x80 mmHg (24 hours ABPM).
* eGFR by the CKD-EPI equation between 45 ml/min/1.73m2 and 15 ml/min/1.73m2 (in conservative treatment of CKD).

Exclusion Criteria:

* Professional drivers;
* Home supplemental oxygen users;
* Patients under current treatment for OSA;
* Pregnant women;
* Patients with malignant neoplasms or terminal illnesses;
* Severe asthma or chronic obstructive pulmonary disease;
* Patients with systemic lupus erythematosus, amyloidosis or systemic sclerosis;
* Patients with a history of solid organ transplants.
Evaluation of Intracanal Reinforcement with Short Composite Post in Upper Primary Incisors with Severly Carious Teeth As in Early Childhood Caries Cases Using Randomized Clinical Trial

Severely damaged incisors may lead to difficulty in speech, decreased masticatory efficiency, abnormal tongue habits, subsequent malocclusions, and psychological and self-esteem problems. There are several methods mentioned in the literature for the restoration of severely decayed primary anterior teeth. The benefits of pulp therapy include: removing cavitations or defects to eliminate areas that are susceptible to caries; stopping the progression of tooth demineralization; restoring the integrity of tooth structure; preventing the spread of infection and preventing the shifting of teeth due to loss of tooth structure. The risks of pulp therapy include lessening the longevity of teeth by making them more susceptible to fracture as after removal of gross caries lesion and gaining access to the pulp the tooth become too weak, recurrent lesions, restoration failure, complications, and iatrogenic damage to adjacent teeth.

There are different techniques can be used for gaining intracanal retention in primary teeth. one of these techniques is resin composite posts.

Composite post restorations have been in used in primary teeth from 1986. They yield satisfactory results when there is normal masticatory function, a balanced diet, and hygiene control.

The evidence to support any method of intracanal reinforcement for restoring grossly broken down anterior teeth is presently lacking.

This study aims to Evaluate the intracanal reinforcement with short composite post in upper primary incisors versus no reinforcement.


Eligibility Criteria:
Inclusion Criteria:

* Children Criteria:

  * Medically free.
  * Cooperative patient.
  * Age (3 - 5 years)

Incisors criteria:

• Upper primary incisors show large carious lesions.

Radiographic criteria:

• No evidence of internal/external pathologic root resorption.

Exclusion Criteria:

* • Uncooperative children.

  * Children with systemic disease.
  * Refusal of participation in the study.
Expanded Access Program of Surufatinib

This treatment protocol is intended to provide early access of surufatinib to patients with locally advanced or metastatic NETs for whom, in the opinion of their treating physician, other treatment options or surufatinib clinical trials in this indication are unsuitable. This EAP is currently available in the US only.

Prior to any assessments, all subjects must provide a signed ICF. Prior to inclusion in the program, the patients must undergo all appropriate screening procedures to check for eligibility.

Once eligibility is confirmed, patients will receive treatment with surufatinib 300mg, orally (PO), daily (QD). All patients will undergo continuous monitoring for safety until the end of treatment.

There is no pre-defined duration of treatment for each patient. Patients will be treated until progressive disease (as defined by treating physician), unacceptable toxicity, death, withdrawal from program, the treatment becomes commercially available, or halting of product development.

A follow-up clinic visit is recommended for all patients approximately 30 days after last dose of treatment to complete the final safety assessments, as applicable.

Eligibility Criteria:
Inclusion Criteria:

1. Histologically or cytologically documented, well differentiated, locally advanced or metastatic NETs
2. The patient or parent/legal guardian (as appropriate) is willing and able to provide informed consent, and where required, the patient is willing to provide assent
3. ≥12 years of age
4. In the opinion of the patient's treating physician, other treatment options or clinical trials in this indication are unsuitable
5. Patient has adequate bone marrow and organ function
6. Urine dipstick ≤1+ for proteinuria or ≤30 mg/dL in urinalysis,
7. ECOG ≤2 for adult patients (≥18 years of age), Karnofsky ≥60 for patients \>16 and \<18 years of age, and Lansky ≥60 for pediatric patients ≤16 years of age
8. For female patients of childbearing potential and male patients with partners of childbearing potential, agreement (by patient and partner) to use a highly effective form(s) of contraception

Exclusion Criteria:

1. Uncontrollable hypertension, as defined by local institution
2. Gastrointestinal disease or condition that the physician suspects may affect drug absorption
3. History or presence of a serious hemorrhage
4. Clinically significant cardiovascular disease
5. Brain metastases and/or spinal cord compression untreated with surgery and/or radiotherapy
6. High risk of bleeding at screening due to tumor invasion
7. Arterial thrombosis or deep venous thrombosis within 6 months prior to first dosing or thromboembolic events (including stroke and/or transient ischemic attack) within 6 months prior to first dosing
8. Received treatment with anticancer therapy, including investigational therapy, within 7 days or 5 half-lives (whichever is longer)
9. Received prior treatment with surufatinib
10. Inability to take medication orally
11. Any other clinically significant comorbidities that, in the judgment of the treating physician, could predispose the patient to safety risks
Correlation Between Minimum Inhibitory Concentration and Clinical Outcome of Invasive Fusariosis

Multi-centered, international, observational and retrospective study to analyze the correlation between MIC and clinical outcome in patients with invasive fusariosis.


Eligibility Criteria:
Inclusion Criteria:

* Invasive fusariosis diagnostic
* Proof of anti-fungic susceptibility according to EUCAST or CLSI, for the medicine used in the treatment of invasive fusariosis.
* Available data about anti-fungic medicines used: name of medicine, start and end date of treatment.
* Available information about clinical outcome of illness after 30 days, 6 weeks and 90 days (dead or alive).
* Only cases of invasive fusariosis proven or possible will be included.

Exclusion Criteria:

* None
Dexamethasone Intravitreal Implant in Retinal Vein Occlusion

Purpose: To evaluate retinal functional improvement by means of visual acuity and retinal sensibility examination after intravitreal dexamethasone implant in patients affected by cystoid macular edema secondary to retinal vein occlusion.

Cystoid macular edema represents the most important cause of visual impairment after retinal vein occlusion. The etiological factors of this complication are under investigation, from inflammatory cytokines to the breakdown of vascular barrier with increased permeability and diffusion of angiogenic factors. Clinical research developed different drugs and therapeutic strategies to treat and control macular edema, to evaluate the correct timetable and to reach long-term clinical significative results. At now, different experiences have been published with available drugs, from steroids to anti Vascular Endothelial Growth Factor. A debate still remains about the correct approach, the correct combination of drugs (if necessary) and the correct evaluation of drug effectiveness.

In our study, we will evaluate extensive functional recovery and its relation to macular thickness after steroid injection. Considering that visual acuity reflects only foveal function, it may not be sufficient to evaluate the overall function on the macular area. We introduce microperimetry study as a valuable and reproducible tool to create a functional mapping of the entire macula.

Eligibility Criteria:
Inclusion criteria were: age older than 18 years; CME secondary to retinal vein occlusion, disease duration inferior to 12 weeks; best-corrected visual acuity (BCVA) between 20/200 and 20/25 (Snellen equivalent) in the study eye at baseline examination, central retinal thickness (CRT) superior to 300 mm, as measured by optical coherence tomography at baseline examination.

The exclusion criteria were any ocular surgery in the study eye in the past 6 months; diabetes mellitus with signs of diabetic retinopathy; previous laser photocoagulation; previous intravitreal injection of corticosteroids or anti-vascular endothelial growth factor; a history of ocular inflammation; marked retinal ischemia or retinal hemorrhages (in particular in macular region involving the fovea); any other ocular condition such as anterior ischemic neuropathy, amblyopia or significant media opacities; significant alteration on epiretinal surface such as epiretinal membrane or vitreomacular traction; uncontrolled or advanced glaucoma; any uncontrolled systemic disease.
Neuroimaging of Donor Iron Deficient Study

This pilot study is designed to investigate (1) whether getting iron treatment affects iron in the brain and (2) how getting iron treatment affects brain functions when it is performing specific cognitive tasks. By cognitive tasks, it means tasks that involve perceiving, representing, or assessing things. The specific cognitive tasks used here will involve tests of memory and processing speed.

Iron, the most abundant metal in the brain, is vital for multiple cellular processes, including neurotransmitter synthesis, neuron myelination, and mitochondrial function. In the United States, of the donors who provided the \~15 million units of red blood cells that were collected for transfusion, 69% were repeat donors. Although iron deficiency is surprisingly prevalent in first-time donors, its prevalence is even higher in these particularly altruistic frequent donors, (i.e., up to 49% and 66% of male and female repeat donors, respectively), manifested as iron depletion or iron-deficient erythropoiesis. Iron deficiency from blood donation is associated with fatigue, restless leg syndrome, decreased physical endurance and work capacity, and impaired concentration, attention, and other neurocognitive functions; however, these conclusions are not based on definitive studies and have not yet changed blood donation policy. This study is to collect data through noninvasive procedures routinely employed in clinical practice to better understand how iron treatment may affect brain functions.

Eligibility Criteria:
Inclusion Criteria:

* Current participant of the associated randomized controlled trial conducted at Columbia University Medical Center (therefore invited to participate in this optional ancillary study).

Exclusion Criteria:

* Not a current participant of the associated randomized controlled trial conducted at Columbia University Medical Center.
mHealth Intervention in Increasing HPV Vaccinations in College Students

This randomized pilot trial studies how well a mobile health (mHealth) intervention works in increasing human papillomavirus (HPV) vaccination among college students at the Ohio State University. mHealth educational intervention may communicate information about HPV vaccination and increase HPV vaccine uptake in college students.

PRIMARY OBJECTIVES:

I. Pilot test an mHealth HPV vaccine intervention for college students to establish feasibility and acceptability.

II. Obtain preliminary efficacy data on whether the mHealth HPV vaccine intervention increases HPV vaccine initiation compared to the control group.

SECONDARY OBJECTIVES:

I. Examine whether the mHealth HPV vaccine intervention affects secondary outcomes compared to the control group.

OUTLINE: Participants are randomized to 1 of 2 arms.

ARM I: Participants receive targeted HPV vaccine narrative-style video via the mobile-friendly website. Participants also receive monthly HPV vaccination reminders via email or by text message.

ARM II: Participants receive standard information about HPV and then HPV vaccine information statement (VIS) via the mobile-friendly website.

After completion of study, participants are followed up at 3 and 7 months.

Eligibility Criteria:
Inclusion Criteria:

* Currently enrolled as a first year Ohio State University (OSU) student on the Columbus campus
* Being able to read English
* Not having received any doses of the HPV vaccine
The Efficacy And Safety Of Mitizodone Phosphate Tablets In The Treatment of Patient With Major Depressive Disorder

This is a phase 2 and 3 adaptive design study for Mitizodone Phosphate,to find out an optimal dose in phase 2 period and confirm the result an efficacy and safety in phase 3 period.Dose-finding will be done after 8 weeks of double-blinded treatment in phase 2 period and will be assessed by both efficacy and safety from 3 dose groups of Mitizodone Phosphate.The dose be found in phase 2 period will be evaluated on efficacy and safety when compared with placebo in phase 3 period with a duration of 8 weeks treatment.The target subjects are patients with MDD.


Eligibility Criteria:
Inclusion Criteria:

* 1.a Man or a woman with major depressive disorder(MDD) as the primary diagnosis according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria (classification code 296.22、296.23、296.32、296.33)
* 2.Has a Montgomery Åsberg Depression Rating Scale (MADRS) total score of 26 or greater at Screening and Baseline Visits.
* 3.Has a Clinical Global Impression - Severity of Illness (CGI-S) score of 4 or greater at Screening and Baseline Visits.

Exclusion Criteria:

* 1.has major depressive disorder with psychotic features according to the DSM-5.
* 2.Current or history of: bipolar disorder、schizophrenia、anixety disorder、insomnia、any substance abuse or dependence and other psychiatry disorder as defined in the DSM-5.
* 3.Current or history of a clinically significant neurological disorder (including epilepsy、Alzheimer disease, Parkinson disease, multiple sclerosis, Huntington disease).
* 4. has Serious body disease such as neurological disorders、cardiacvascular disorders、hepatic disorders、 renal disorders, blood system disorders and endocrine disorders.
* 5. Current or history of cancer( except basal cell of the skin and preinvasive carcinoma of cervix uteri).
* 6. Current or history of angle-closure glaucoma.
* 7. has made a suicide behavior in the previous 1 year ，or has a score greater than or equal to 4 on item 10 (suicidal thoughts) of MADRS .
* 8.has taken fluoxetine within 4 weeks prior to initial dosing.
* 9. has taken other antidepressive medications or antipsychotic medications within 2 weeks prior to initial dosing.
* 10.has psychotherap at Screening and/or Baseline Visits.
* 11.has had physiotherapy within 3 months prior to initial dosing.
* 12.Has an alanine aminotransferase, aspartate aminotransferase or total bilirubin level greater than 1.5 times the upper limits of normal.
* 13.Has an alanine aminotransferase, aspartate aminotransferase level greater than 2 times the upper limits of normal；or total bilirubin， direct bilirubin，creatinine level greater than 1.5 times the upper limits of normal；or a thyroid stimulating hormone value outside the normal range.
* 14.Has an abnormal electrocardiogram confirmed as clinically significant by the investigator.
* 15.Has a history of severe allergies.
GeneSearch™ Breast Lymph Node (BLN) Assay China Registration Study

The primary objective of this trial is to compare GeneSearch™ Breast Lymph Node (BLN) Test Kit to permanent pathological section, so as to evaluate the clinical sensitivity and specificity of GeneSearch™ Breast Lymph Node (BLN) Test Kit in detecting axillary sentinel lymph node metastases in breast cancer patients.

The secondary objective of this trial is to evaluate the positive predictive value and negative predictive value of GeneSearch™ Breast Lymph Node (BLN) Test Kit when used in the detection of axillary sentinel lymph node metastases in breast cancer patients.

Prospective and multi-center clinical trial


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed previously as breast cancer
* patient scheduled for sentinel lymph node dissection
* 18 years or older
* female or male, and
* able and willing to give consent to participate in the study

Exclusion Criteria:

* Patients taking part in other research studies that would interfere with their full participation in this study, or
* Prior sentinel or partial axillary lymphadenectomy on the same body side
Management of Lumbar Discectomy by Endoscopy and Conventional Microscopic Discectomy

Currently, microscopic discectomy is performed as a minimally invasive surgery, thus reducing impact of so-called conventional "open" discectomies.

Although more technically demanding, discectomy with full endoscopy made possible a significant reduction of surgery invasive impact, thus making possible to broaden the field of endoscopic surgery indications.

This study is based on hypothesis that complete endoscopic discectomy offers several advantages over traditional microscopic discectomy, including a smaller skin incision and therefore fewer scars and less muscle damage, lower infection rate, less blood loss, less painful post-operative recovery and shorter hospital stay length.

Discectomy is the most common surgical technique to solve lumbar radiculopathy caused by disc herniation and nerve roots compression .

Currently, microscopic discectomy is performed as a minimally invasive surgery, thus reducing the impact of so-called conventional "open" discectomies.

Minimally invasive spinal surgery was developed using a retractor tube, a microscope, and an endoscope to perform efficient nerves decompression while preserving spinal cord stabilizing structures.

Although more technically demanding, discectomy with full endoscopy made possible a significant reduction of surgery invasive impact, thus making possible to broaden the field of endoscopic surgery indications.

This study is based on hypothesis that full endoscopic discectomy offers several advantages over traditional microscopic discectomy, including a smaller skin incision and therefore fewer scars and less muscle damage, lower infection rate, less blood loss, less painful post-operative recovery and shorter hospital stay length.

Eligibility Criteria:
Inclusion Criteria:

* Patient, male or female, aged ≥ 18 years
* Patient operated under endoscopy for lumbar disc herniation between February 2020 and May 2022
* Patient operated by conventional microscopic surgery for lumbar disc herniation before February 2020
* Patient having been informed of the research and not opposing its data use as part of this research

Exclusion Criteria:

* None