cyrilzakka/clinical-trials huggingface dataset:
Study on the Application of Intraoperative Optical Coherence Tomography Technique in the Diagnosis and Treatment of Lens Diseases

Accurately assessing and dealing with anterior segment changes in the eyes of patients with lens diseases can better guide the operation details during surgery and make reasonable plans for possible intraoperative and postoperative complications. Applying the intraoperative optical coherence tomography technique, this study analyzes the correlation between preoperative, intraoperative anterior segment structural changes and postoperative surgical effects in patients with lens diseases, and evaluates the clinical benefits of intraoperative optical coherence tomography technique in lens surgery. This study is intended to further improve the diagnosis and treatment quality of clinical lens diseases.

In the eyes of patients with lens diseases, there are often some special anterior segment changes, including ectopia lentis, abnormal lens morphology, and rupture of the lens capsule. These changes can be caused by ocular trauma, congenital anomalies, or be secondary to other ocular diseases and systemic diseases. Accurately assessing and dealing with these anterior segment changes can better guide the operation details during surgery and make reasonable plans for possible intraoperative and postoperative complications. This study is based on intraoperative optical coherence tomography technique, analyzes the correlation between preoperative, intraoperative anterior segment structural changes and postoperative surgical effects in patients with lens diseases, and evaluates the clinical benefits of intraoperative optical coherence tomography technique in lens surgery. This study is intended to further improve the diagnosis and treatment quality of clinical lens diseases.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged over 18 years old, with lens opacity or abnormal position, and other conditions meeting the surgical indications, needing lens surgery treatment, with or without anterior segment structural changes.

Exclusion Criteria:

* Combined with other eye diseases that seriously affect visual prognosis, serious systemic diseases and other conventional contraindications for lens surgery.
Safety and Efficacy of His Bundle Pacing Validated by Extracardiac Vagal Nerve Stimulation

Different studies for extracardiac vagal nerve stimulation (ECANS) have been published and confirmed the influence of the vagus nerve on automaticity and conduction properties of the sinus node, atria, atrioventricular node, as well as the His-Purkinje system (HPS) and ventricles. However, there are limited data on the clinical value and impact of ECANS as well as vagus nerve activity on the parameters of permanent His-bundle (HB) or left bundle branch (LBB) pacing. Moreover, there have been no prospective studies evaluating the feasibility and efficacy of ECANS and the management of ECANS-induced scenarios, such as an exit block, increase in pacing threshold, as well as vagally mediated arrhythmias and conduction abnormalities in patients with physiological conduction system pacing (HB/LBB pacing).

The objective of the HIS-STORY study in humans is to evaluate the clinical value of ECANS in patients with HB/LBB pacing for further development of patient-centered management strategy.

This is a multicenter, prospective, open-label, randomized, interventional study enrolling patients with indications for permanent cardiac pacing according to the current European Society of Cardiology Guidelines on Cardiac Pacing. All participants will undergo permanent pacemaker implantation for HB or LBB pacing. Subsequently, an invasive electrophysiological study (EPS) and ECANS will be performed. The 2 x 2 randomisation will be performed, i.e. right vs left side superior ECANS and blinded for operator ultrasonography guided effective vs ineffective inferior vagal nerve stimulation). The randomisation will prove the feasibility and efficacy of superior ECANS and feasibility, efficacy, and reproducibility of ultrasonography guided inferior ECANS. All the measured parameters as well as demographic and clinical data will be recorded in the study database. Patients with an exit block or an increase in a pacing threshold of an HB/LBB electrode will be further managed by electrophysiologists from the research group. The management will be based on clinical assessment and patient's decision and may involve pacemaker reprogramming, pacemaker upgrade with a back-up pacing electrode implantation, or cardio-neuro-ablation.

Eligibility Criteria:
Inclusion Criteria:

* signed informed consent form
* effective and stable HB or LBB pacing
* sinus rhythm during the intervention procedure

Exclusion Criteria:

* contraindications to invasive EPS
* contraindications to general anesthesia
* contraindications to atropine administration (e.g., glaucoma)
* persistent atrial fibrillation or atrial flutter
* pregnancy
* diseases that may cause autonomic system neuropathy
* use of medications that may affect the parasympathetic system
* a history of cardiac surgery
* a history of ablation due to arrhythmia
Testing the Interactive Effects of Delta-9-Tetrahydrocannabinol and Pregnenolone: Sub-Study I

The overall purpose of this study is to examine the effect of Pregnenolone (PREG) on the acute psychosis-like and cognitive effects of Delta-9-Tetrahydrocannabinol (THC). This will be tested by pretreating healthy individuals with PREG, and then assessing their responses to Dronabinol (THC).


Eligibility Criteria:
Inclusion Criteria:

* Exposed to cannabis at least once in lifetime

Exclusion Criteria:

* Cannabis naïve
* Individuals with a documented reaction/allergy to Pregnenolone
* Individuals with a documented reaction/allergy to Sesame oil
Nonmyeloablative Stem Cell Transplant in Children with Sickle Cell Disease and a Major ABO-Incompatible Matched Sibling Donor

The aim of this study to evaluate the safety and efficacy of a nonmyeloablative conditioning regimen for allogeneic hematopoietic stem cell transplantation (HSCT) in pediatric patients with sickle cell disease (SCD) who have a matched related major ABO-incompatible donor. The nonmyeloablative regimen will use alemtuzumab, total body irradiation (TBI) and sirolimus for immune suppression. This study will expand the access of HSCT for patients with SCD who are currently not eligible because of donor restrictions.

Sickle cell disease (SCD) is a debilitating chronic blood disorder with multi-system end-organ damage that leads to morbidity and early mortality. The only cure for SCD is hematopoietic stem cell transplantation (HSCT), which given the risks with unrelated HSCT, is only an option for a minority of patients who have a matched sibling donor.

In the field of HSCT, blood group ABO incompatibility between donor and recipient is not a contraindication and several studies do not show compromised outcomes. However, in the context of nonmyeloablative (NMA) conditioning and major ABO-incompatibility, when the recipient has existing antibodies to donor red blood cells, pure red cell aplasia (PRCA) may occur.

This phase II pilot study will enroll SCD patients with a matched related major ABO-incompatible donor to determine the safety and efficacy of NMA-HSCT. Biological studies will include a plan to study and monitor red cell engraftment in this population to facilitate early detection and interventional measures to prevent and treat PRCA.

Eligibility Criteria:
Inclusion Criteria:

* Patients must be ≥ 12 months and \< 19 years of age at the time of study enrollment.
* Patients must have sickle cell disease as defined by hemoglobin electropheresis, as follows:

  * homozygous Hb S disease (HbSS),
  * sickle-Hb C disease (HbSC),
  * sickle beta-plus-thalassemia (HbS/β+), or
  * sickle beta-null-thalassemia (HbS/βo)
* Patients must meet standard eligibility criteria to undergo HSCT, including but not limited to one or more of the following:

  * history of repeated (more than 1) bony (vaso-occlusive) crisis
  * history of stroke
  * elevated transcranial Doppler velocity not eligible for hydroxyurea, as per TWiTCH trial (ie. severe vasculopathy)
  * history of acute chest crisis or splenic sequestration crisis
  * history of priapism in males
  * history of osteonecrosis
  * pulmonary hypertension as documented by tricuspid regurgitation jet velocity (TRV) \> 2.5 m/s on echocardiogram
  * red cell allo-immunization (≥ 2 antibodies) during long term transfusion therapy
* Sickle complications should be present despite the use of hydroxyurea, but this is not an absolute requirement, if the treating team considers the patient to be at high risk for further crisis episodes.

Exclusion Criteria:

* Patients who are unable to comply with or follow the study protocol.
* Patients with known hypersensitivity to sirolimus, its derivatives or to any of its components.
A Study to Compare Forms of Nemtabrutinib (MK-1026) in Healthy Adult Participants (MK-1026-007)

The goal of the study is to measure and compare the levels of nemtabrutinib in the blood after taking different forms of nemtabrutinib orally on an empty stomach (fasted) to see if they are the same or different.


Eligibility Criteria:
Inclusion Criteria:

The key inclusion criteria include but are not limited to the following:

* Is in good health before randomization
* Has a body mass index (BMI) ≥18 and ≤32 kg/m\^2, inclusive

Exclusion Criteria:

The key exclusion criteria include but are not limited to the following:

* Has a history of clinically significant endocrine, gastrointestinal (GI), cardiovascular, hematological, hepatic, immunological, renal, respiratory, genitourinary, or major neurological (including stroke and chronic seizures) abnormalities or diseases
* Has a history of cancer with pre-specified exceptions (adequately treated non-melanomatous skin carcinoma or carcinoma in situ of the cervix or other malignancies that have been successfully treated with appropriate follow up and therefore unlikely to recur for the duration of the study, per protocol guidelines)
Evaluating the Efficacy of Using a Digital Consumption Management Tool for Family Planning in Zambia

The primary objective of this evaluation is to understand the effectiveness of the OpenSRP platform on unmet family planning (FP) demand in rural Zambia. The specific objectives are to:

1. assess the impact of the intervention on satisfaction and use of modern family planning methods among last-mile people of childbearing potential; and
2. understand the impact of the intervention on FP inventory management and dispensing.

The investigators will employ mixed-methods for data collection for this two-arm cluster-randomized trial. This effectiveness evaluation will be paired with a concurrent implementation evaluation, making it a Type 2 Hybrid Design.

For the impact evaluation data will be collected from two main sources at both baseline and endline: 1) existing stock management records (eLMIS and paper records, depending on study arm); and 2) Short phone surveys with people of childbearing potential in the community.

Rural health facilities catchment areas (HFCAs) and their affiliated CHWs (clusters) will be randomly assigned to the intervention or control arm. The impact evaluation will consist of a cross-sectional baseline assessment of a sample of women living in the catchment areas of both the intervention and control clusters. This will be followed by a six months of implementation phase (mobile device distribution to CHW, CHW training, CHW utilization of the Open SRP). At endline after six months, a new cross-sectional sample of respondents will be assessed in both the intervention and control clusters.

To achieve objective 1, a short questionnaire will be administered over the phone to a cross-sectional sample of last-mile people of childbearing potential living in both the intervention and control clusters. The sample will be drawn from the CHW's client lists and use a short telephone call to reach respondents.

To achieve objective 2, the same quantitative indicators will be abstracted from two different data sources, depending on the study arm: 1) OpenSRP data captured in the CHW tablets among the intervention sites, and 2) data extracted from the paper records maintained by the CHWs or the health facility or the electronic management system in the control sites (and at baseline).

Eligibility Criteria:
Inclusion Criteria:

* Resident in a study health facility catchment area (HFCA)
* Family planning (FP) client of community health worker (CHW) affiliated with one of the study sites
* Access to a mobile phone

Exclusion Criteria:

* Unwilling or unable to consent
* Currently pregnant
* Currently breastfeeding
Family Cohort Study on Primary Osteoporosis

Bone metabolism and genetic characteristics of osteoporosis pedigree with kidney-yang deficiency

Families with or without osteoporosis of kidney-yang deficiency type will be included and compared with each other. Their genetic characteristics, bone changes, and TCM constitution are the focus of research.

Eligibility Criteria:
Inclusion Criteria:

* Be able to cooperate with inspection.There is blood relationship between the members of the enrolled family.

Exclusion Criteria:

* Unable to cooperate with inspection.There is not blood relationship between the members of the enrolled family.
Effect of Tourniquet on UKA

There is obviously a lack of evidence regarding the risk-benefit ratio of a thigh tourniquet in unicondylar knee arthroplasty (UKA). This refers to many possible outcome criteria like operating time, blood loss, quality of prosthesis fixation in the bone, adverse events, radiographic result, clinical score outcome, easy of rehabilitation etc. It is not appropriate to rely on findings from the field of total knee arthroplasty.

It is the aim of the current study, to clarify the role of a thigh tourniquet during UKA with regard to component fixation quality, component positioning and sizing, clinical outcome and rehabilitation process.

Patients scheduled for routine UKA implantation due to osteoarthritis or osteonecrosis in the medial compartment will be considered for participation.

Patients are then randomized for surgery with or without tourniquet. After an anteromedial Quad-Sparing approach the UKA procedure itself is then carried out, as suggested by the manufacturer. For both groups puls lavage and meticulous drying is applied before cementing.

The following outcome parameters are assessed: 1)radiographic cement mantle thickness, 2)component position \& sizing, 3)diolucencies, 4)score outcome and 5)parameters of early Rehab.


Eligibility Criteria:
Inclusion Criteria:

* waiting list for unicondylar knee arthroplasty

Exclusion Criteria:

* failed upper tibial osteotomy,
* insufficiency of the collateral or anterior cruciate ligaments,
* a fixed varus or valgus deformity (not passively correctable) above 15°,
* a flexion deformity greater than 15° and 5) rheumatoid arthritis. In addition - with regard to the scope of the current study - further exclusion criteria will be
* intake of medicinal anticoagulation prior to surgery
* liver dysfunction / coagulation dysfunction
* peripheral arterial obstructive disease.
Mirabegron Combined With Behavioral Intervention for Overactive Bladder：a Prospective Multicenter Randomized Controlled Clinical Study

The purpose of this study was to assess the efficacy, safety and tolerability of Mirabegron and behavioral combination versus Mirabegron alone in the treatment of women with overactive bladder (OAB）.


Eligibility Criteria:
Inclusion Criteria:

* 1. Female aged between 40-60 years old, and no abnormalities were found in general examination, neurological examination and pelvic examination. 2. Patients with urgent urination for more than 3 months, with or without urgent incontinence, often with frequent micturition and nocturia, have normal urine routine. 3. The patients who were diagnosed as OAB by the following questionnaires, with 6≤ score ≤11 is moderate OAB, with score≥12 is severe OAB, and selected moderate and severe OAB patients. 4. Willing to join the study with signed ICF.

Exclusion Criteria:

* 1. Other diseases as obvious reasons causing OAB symptoms. 2. Patients with hypertension, of whom blood pressure is as high as 180/110 mm Hg or above. 3. Patients with gynecological malignancies, pelvic radiation therapy, stress urinary incontinence or mixed urinary incontinence with predominant stress incontinence. 4. Those taking OAB treatment drugs; 5. Pregnant (blood G-HCG determination if necessary) or lactating women; 6. Women with liver and kidney dysfunction, immunosuppressive agents, blood diseases, diabetes, mental illness or other serious diseases. 7. Poor compliance. 8. Allergic constitution, or allergic to the type of study drug
Educational Program for Hearing Aid Users With Internet Support

The purpose of this study is to examine the short-term effects of complementing an educational program for hearing aid users with Internet support.

Aural rehabilitation aims to improve communication for people with hearing impairment. Education is widely regarded as an integral part of rehabilitation, but the effect of the delivery method of an educational program on the experience of hearing problems has rarely been investigated in controlled trials. Internet as a complement to aural rehabilitation has been tested in different studies with promising results. Though, until now not applied clinically as a part of an aural rehabilitation, focusing on hearing aid users with persistent self- reported hearing problems.

The purpose of this study was to evaluate the effect of an internet-based aural rehabilitation for hearing aid users from a clinical population.

Participants were randomly assigned to an intervention or control group. The intervention group followed a five-week program that consisted of reading material, home training assignments, online and telephone interaction with an audiologist, and participation in a discussion forum. The control group only had access to reading material.

The Hearing Handicap Inventory for the Elderly (HHIE), the Hospital Anxiety and Depression Scale (HADS) and the Communication Strategies Scale (CSS) were used to measure the outcomes of this study; and were recorded before and directly after the intervention as well as 6 months post-intervention.

Eligibility Criteria:
Inclusion Criteria:

* the hearing aid users to be between 20 and 80 yr of age,
* the hearing aid users to have conductive or sensorineural hearing loss of mild to moderate degree (20-60 decibel Hearing Level pure-tone average measured across 500, 1000, and 2000 Hertz),
* the hearing aid users to have completed a hearing aid fitting at least 3 months before the study began (regardless of hearing aid manufacturer, model, or hearing aid outcomes),
* the hearing aid users to have a Hearing Handicap Inventory for the Elderly (HHIE) score of \>20 points (indicative of some residual self-reported hearing problems),
* the hearing aid users to provide informed consent to participate

Exclusion Criteria:

* the hearing aid users who are not fulfilling the conditions to participate
Efficacy of Monosialotetrahexosylganglioside in the Prophylactic Treatment of Bortezomib-induced Peripheral Neuropathy

Bortezomib was an important drug in the treatment of multiple myeloma (MM),and peripheral neuropathy (PN) is a significant dose-limiting toxicity of bortezomib that typically occurs within the first courses of bortezomib, reaches a plateau at cycle 5. Up to now, no effective prophylaxis have been developed for PN. Monosialotetrahexosylganglioside, a nerve-protecting drug,was often used to promote growth of nerve, and function restoration of damaged nerve.Thus,the investigators hypothesized that combination of Monosialotetrahexosylganglioside and bortezomib can reduce the incidence rate of peripheral neuropathy (PN) and promote the relief of peripheral neuropathy (PN) in multiple myeloma (MM) patients.


Eligibility Criteria:
Inclusion Criteria:

* Histologic diagnosis of multiple myeloma;
* Age:18-80 years;
* Eastern Cooperative Oncology Group (ECOG) status 0-3,
* Estimated survival time \> 3 months;
* Acceptable liver function (bilirubin\<2.5×ULN, Alanine transaminase (ALT) or Aspartate Aminotransferase (AST)\<2.5×ULN),
* No history of other malignancies;
* No previous treatments including chemotherapy, radiotherapy, targeted therapy or stem cell transplantation;
* No other serious diseases which conflict with the treatment in the present trial;
* No concurrent treatments that conflict with the treatments in the present trial;
* Voluntary participation and signed the informed consent.

Exclusion Criteria:

* The patients had the conditions below: clinically significant ventricular tachycardia (VT), atrial fibrillation (AF), heart block, myocardial infarction (MI), congestive heart failure (CHF), symptomatic coronary artery heart disease requiring medication;
* The patients participated in other clinical trials within the 30 days before enrollment or who are participating in other clinical studies;
* The patients with neuropathy;
* The patients with mentally ill / unable to obtain informed consent;
* The patients with drug addiction, alcohol abuse which affects the long-term evaluation of test results;
* The patients in pregnancy, lactation and women of childbearing age who do not want to take contraceptive measures subjects;
* The patients with a history of allergy to test drug;
* The patients not suitable to participate in the investigator judged by researchers.
Evaluation of Inflammatory Markers in LARC Patients

Introduction: In locally advanced rectal cancers (LARC), TNM staging is far from optimal. We aimed to investigate the value of previously described circulating biomarkers as predictors of prognosis.

Methods: Retrospective analysis of 245 LARC patients diagnosed between January 2010 and December 2022, who underwent neoadjuvant chemoradiotherapy and surgery at two centers. A Cox regression and Kaplan-Meier analysis were performed.


Eligibility Criteria:
Inclusion Criteria:

* patients diagnosed pathologically with rectal adenocarcinomas, located within 12cm from the anal verge (measured by MRI), clinically staged T3-4 and/or N+ and treated with neoadjuvant chemoradiotherapy (nCRT) followed by radical surgery

Exclusion Criteria:

* evidence of distant metastasis at diagnosis, emergent or palliative surgery, local excision or "watch and wait" approach and evidence of inflammatory or hematological disorders