cyrilzakka/clinical-trials huggingface dataset:
An Exploratory Clinical Study of SHR6390 and SHR1020 in the Treatment of Esophageal Squamous Cell Carcinoma After Progression on PD-1 Antibody

This study is being conducted to explore the efficacy of SHR-6390 and SHR-1020 in the treatment of esophageal squamous cell carcinoma after progression on PD-1 Antibody.


Eligibility Criteria:
Inclusion Criteria:

* Patients who were diagnosed as esophageal squamous cell carcinoma by histopathology with at least one measurable lesion according to RECIST 1.1 criteria.
* Must have had progressive disease after previous treatment with PD-1 inhibitor
* ECOG score 0-2
* The expected survival time is ≥ 12 weeks
* Previous permanent discontinuation did not occur due to adverse events associated with immunotherapy, or the immunotreatment-related adverse events recovered to ≤1 grade

Exclusion Criteria:

* Had other active malignant tumors within 5 years before entering the study
* Had abnormal swallowing function or dysfunction of gastrointestinal absorption
* The first study drug treatment was less than 28 days or 5 half-lives (in terms of longer) from the last radiotherapy, chemotherapy, targeted therapy or immunotherapy
* Patients who have already received surgery within 28 days (biopsy for diagnosis is permitted)
* Pregnant or lactating women
Efficacy Study of AlphaBRAIN Administered Orally

The manufacturers of AlphaBRAIN(TM) claim that their product, when taken as directed, has beneficial effects on cognition. The active ingredient in AlphaBRAIN, Huperzine A, is a naturally occurring compound found in firmoss and also thought to be an acetylcholinesterase inhibitor. Numerous clinical studies have been undertaken to investigate the effects of Huperzine A on cognition and have demonstrated benefit to cognition in both individuals diagnosed with neurodegenerative diseases as well as performance on academic tasks by students. However, to our knowledge, there are no randomized controlled trials evaluating the effects of AlphaBRAIN(TM) on cognition. Thus, the purpose of the current study is to assess the effects of daily oral administration of AlphaBRAIN(TM) on cognitive functioning, as compared to placebo, after 45 days of treatment.

1. To evaluate a single daily dose of AlphaBRAIN(TM) vs placebo given orally on the change in a battery of standardized neuropsychological tests (see attached).
2. A secondary objective is to evaluate a single daily dose of AlphaBRAIN(TM) vs placebo given orally on sleep.


Eligibility Criteria:
Inclusion Criteria:

* Community dwelling and can provide informed consent.
* MMSE score of ≥ 26.
* Body Mass Index within two standard deviations of the norm.
* Fluent in English.
* Willing to complete all study assessments.
* Adequate visual and auditory acuity to allow for neuropsychological testing.

Exclusion Criteria:

* MMSE score \< 26
* Body Mass Index greater then two standard deviations from the norm.
* Visual or Auditory disability which would interfere with neuropsychological testing.
* No past diagnosis of Stroke, ADD/ADHD, Learning Disability or Cardiac Condition.
* No current life threatening illnesses.
* Not currently (past 60 days) taking antidepressants or other psychoactive medications.
* Not currently taking any non-prescription cognitive enhancers (nutraceuticals or vitamins such as Ginko biloba.
* No history of alcohol or drug or dependence as defined by the DSM-IV-TR.
A Single Group Study to Evaluate the Effects of a Boric Acid Suppository on Vaginal Health.

This is a virtual single-group clinical trial that will last 12 weeks. Participants will use The Killer® (Boric Acid Suppositories) once daily for 7 consecutive days when they feel that they are experiencing any of the common signs of vaginal imbalance like vaginal malodor, vaginal irritation, and/or vaginal itching. Participants will complete a questionnaire before using the product and on Days 3 and 7 of using the product. They will also complete a vaginal swab pH test before using the product and after 7 days of using the product (Day 8).


Eligibility Criteria:
Inclusion Criteria:

* Female at birth
* Aged 18+
* Interested in maintaining a calm, soothed, and healthy vaginal environment and balanced vaginal pH levels
* Regularly experience atypical vaginal smell, discharge, itching, swelling, irritation, pain or - burning during sex, and/or a burning sensation while urinating
* Willing to avoid introducing any products or new forms of prescription medication or supplements targeting vaginal health during the study period
* Has used a boric acid suppository before
* Willing to avoid the use of any intra-vaginal products during the study product use
* Willing and able to follow the study protocol

Exclusion Criteria:

* Surgeries or invasive treatments in the last six months or planned during the study period
* Introduced any products or forms of prescription medication or supplements targeting vaginal health in the last 12 weeks
* Known allergies to the product ingredients
* Diagnosed with chronic health conditions impacting participation
* Pregnant, breastfeeding, or trying to conceive
* History of substance abuse
* Current or former smoker within the past six months
* Unwilling to follow the study protocol
* Currently participating in any other clinical trial or perception study
Common Recreational Diving Practices: A Randomized Control Trial Using Pre-Dive Checklist

To evaluate the efficacy of using a pre-dive checklist to prevent the incidence of diving mishaps in recreational divers.


Eligibility Criteria:
Inclusion Criteria:

* Over 18 years of age
* Having a valid Diver Certification
* Deemed fit by the Dive operator to dive on the day of participation
* Planning to dive on the day of participation
* Have basic knowledge of English

Exclusion Criteria:

* Anyone not meeting all of the inclusion criteria
* A diver who did not answer the outcomes questionnaire was later excluded
Functional Magnetic Resonance Imaging Study on the Role of Awareness in Visual Perception in Healthy Adult Subjects.

The objective of the study concerns the investigation of the role of awareness in visual perception, highlighting the brain systems involved during non-processing Aware of stimuli belonging to different semantic categories. Specifically, the theoretical perspective of reference is that of the so-called "grounded cognition", according to which the representation of the concepts of semantic knowledge is conveyed by information sensorimotor and affective, introspective and social states. The main objective is therefore to evaluate whether the meaning of the stimulus can be extracted in the absence of awareness, investigating the neural response in the brain regions known to be involved in the conscious processing of stimuli belonging to the semantic categories in question.

To this end, two different experimental paradigms were implemented. A first paradigm aimed at investigating the unconscious representation of semantic knowledge in the context of language, therefore using visual stimuli in lexical mode (words). A second paradigm aimed at investigating the same phenomena in the field of visual perception of objects in space, using stimuli in iconic mode (images).


Eligibility Criteria:
Inclusion Criteria:

* aged between 20 and 65;
* Italian mother tongue.

Exclusion Criteria:

* clinical evidence of significant psychiatric or systemic neurological pathologies.
Prospective Trial of Autologous Platelet Rich Plasma in Aortic Surgery

The purpose of this study is to determine whether autologous platelet rich plasma (APRP)is effective in reducing allogeneic blood transfusions during aortic surgery using deep hypothermic circulatory arrest.


Eligibility Criteria:
Inclusion Criteria:

* patients undergoing elective or emergency aortic surgery using deep hypothermic circulatory arrest、
* preoperative platelet counts\>150000000000/L、
* preoperative hematocrit\>33%、
* without recent anticoagulants less than 5 days

Exclusion Criteria:

* preoperative coagulation disorder
* severe renal and liver dysfunction
* preoperative hemodynamic instability
Speed of Premolar Extraction Space Closure: Every Visit Replacement of Working Archwire

The aims of this trial were to assess the effect of changing 0.019X0.025-inch SS working archwire monthly on the rate of space closure, to compare the frictional resistance of unchanged and new working archwires in-vitro, and to assess its effect on the rate of space closure, to record the amount of ion concentration in the saliva before orthodontic treatment, before space closure and one month after space closure.

The aims were to assess the effect of changing 0.019X0.025-inch SS working archwire monthly on the rate of space closure, to compare the frictional resistance of unchanged and new working archwires in-vitro and to assess its effect on rate of space closure, to record the amount of ion concentration in the saliva before orthodontic treatment, before space closure and one month after space closure and to compare the rate of teeth movement into fresh and old extraction sites.

Trial design: Randomized controlled clinical trial with a split-mouth design. Setting: Jordan University of Science and Technology(JUST) Postgraduate Dental Teaching Clinics and labs.

Participants and interventions: Twenty-eight subjects with bimaxillary proclination requiring extraction of all first premolar teeth participated in this study. In the upper arch two groups were identified; group 1 having the extraction space closed using the same working archwire throughout 3 visits after insertion, and group 2 with the working archwire changed monthly.

The working archwire in the upper arch was split into 2 halves in the midline and each one half was connected to the other by a wide joining hook. Patients were followed-up monthly for three months. At every follow up visit upper alginate impressions were taken and the working archwire in the upper arch was changed on one side only. Upper follow-up models were scanned using digital scanner and spaces were measured using digital software.

Three unstimulated saliva samples were collected from each patient; prior to commencement of treatment, when 0.019X0.25-inch SS archwire was reached and before space closure and one month after space closure.

The rate of extraction space closure in the upper arch, ion concentration in saliva samples measured using inductively coupled plasma mass spectrometer (ICP-MS) and frictional resistance of the working archwires was measured using universal mechanical testing machine.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 16 years
* Proclined upper and lower incisors (Ui/max \>115 o, Li/mand \>99o)
* Mild upper and lower arch crowding (\<4mm) or no crowding
* Need for upper and lower first premolars extraction
* Skeletal I malocclusion (1\<ANB \<5)
* Average lower facial height and maxillomandibular plane angle (22 o \<MM\<32 o)
* Class I canine relationship
* Good oral hygiene and healthy periodontium

Exclusion Criteria:

* Poor oral hygiene
* Diseases and medications that were likely to affect bone biology
* Previous orthodontic treatment
* Evidence of bone loss
* Active periodontal disease
* Smoking
Effects of Basic Carbohydrate Counting Versus Standard Outpatient Nutritional Education in Type 2 Diabetes

The aim of the study is to examine the health benefits of adding a concept in basic carbohydrate counting (BCC) to the routine outpatient nutritional education for adult patients with type 2 diabetes.

The study hypothesis is that training and education in the BCC concept will improve glycaemic control either by reducing HbA1c or the average plasma glucose variability more than offering the routine dietary care as a stand-alone dietary treatment.

The trial has a parallel-group design with a study duration of 48 weeks for each participant (a 6-month intervention period and a 6-month follow-up period). A total of 226 patients will be enrolled in the trial. Participants will be randomized to one of two arms: 1) Standard medical and dietary care (control group) or 2) Structured training and education in the BCC concept in addition to standard medical and dietary care.

The primary objective is to evaluate the six months effect of structured training and education in the BCC concept compared to standard dietary care on glycaemic control as assessed by HbA1c or MAGE (mean amplitude of glycaemic excursions).

Eligibility Criteria:
Inclusion Criteria:

* Type 2 diabetes
* Diabetes duration; from \>12 months
* HbA1c between 53 and 97 mmol/mol
* Diet or any glucose-lowering medication
* Provided voluntary written informed consent

Exclusion Criteria:

* Practicing carbohydrate counting, as judged by the investigator
* Participated in a BCC group program within the last two years
* Low daily intake of carbohydrates (defined as below 25 E% or 100 g/day), as judged by the investigator
* Use of open CGM
* Use of a Free Libre device
* Use of an automated bolus calculator for carbohydrate counting, as judged by the investigator
* Gastroparesis
* Pregnancy or breastfeeding, or plans of pregnancy within the study period
* Uncontrolled medical issues, as judged by the investigator
* Concomitant participation in other clinical studies
* Unable to understand the informed consent and the study procedures
Impact of Asthma Exacerbations

The purpose of the study is to gain a deeper understanding of the impact of asthma attacks on the lives of patients who experience them. This will help us to describe the true extent of the impact of asthma attacks on factors of importance to patients which have not previously been well described, including the psychological, social, financial and emotional burden of asthma attacks.

Additionally, it is hoped that detailed questioning regarding features of asthma attacks from a patient perspective will improve our understanding of patient recognition of attacks, consistency of certain features of attacks and patient views regarding preventative strategies for attacks. Patient experiences of asthma attacks are poorly described in previous research. Hence this work is expected to provide useful insights into these experiences which will contribute to improvements in detecting, treating and preventing asthma attacks.

The study will consist of a one-off interview lasting about 45 minutes with patients who have recently had asthma attacks. We plan to recruit patients for the study from an outpatient clinic for those who have had a recent attack or from a register of patients who have volunteered for future asthma research studies. The interviews will take place in person at the Respiratory Research Unit at the Nottingham City Hospital or over the telephone depending on patient preference.


Eligibility Criteria:
Inclusion Criteria:

* Adults with previous clinician diagnosis of asthma (16 years and above)
* Recent (≤4 weeks) asthma attack for which patient received ≥3 days of systemic corticosteroid treatment

Exclusion Criteria:

* Anyone under the age of 16 years.
* Anyone unable to speak or understand English.
Direct Bypass Versus Indirect Bypass in Treatment of Adults Hemorrhagic Moyamoya Disease

The investigators conducted a prospective multi-center study assessing the effect of direct bypass and indrect bypass in treatment of hemorrhagic moyamoya disease.


Eligibility Criteria:
Inclusion Criteria:

1. cerebral digital subtraction contrast angiography (DSA) revealed severe stenosis or occlusion of the distal internal carotid or proximal middle and anterior cerebral arteries with prominent lenticulostriate "moyamoya collaterals"
2. patients had experienced at least one intracranial hemorrhage which was verified by computed tomography (CT) scanning, magnetic resonance imaging MRI), or lumbar puncture.
3. Patients requiring surgery

Exclusion Criteria:

1. Patient whose initial onset was marked by ischemia but subsequently suffered from intracranial hemorrhage
2. patients refused to participate in the study
Magnesium-L-Threonate for Sleep Quality Post-Arthroplasty

The study team is conducting a study to see if Magnesium-L-Threonate (MgT) can help improve how well participants sleep and reduce pain after total joint replacement surgery


Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing primary total knee or hip arthroplasty at the University of Miami Hospital
* Patients \> 18 years of age
* Subjects must be capable of providing informed consent
* English or Spanish-speaking

Exclusion Criteria:

* Previous total joint arthroplasty at the surgical site
* History of sleeping disorders, including narcolepsy, sleep apnea, insomnia, parasomnias, and restless leg syndrome.
* History of Complex Regional Pain Syndrome in ipsilateral extremity
* History of demyelinating disorder or neurologic deficit in the affected extremity
* History of psychiatric disorders that could impact sleep, such as untreated depression, bipolar disorder, or schizophrenia.
* Participants taking medications known to cause significant sedation or insomnia.
* Pregnant or breastfeeding
* Being treated for a diagnosis other than primary osteoarthritis (e.g. pelvic/femur fracture)
* Patients with known substance use disorder within 6 months of surgery
* Liver Failure, via clinical diagnosis or international normalized ratio greater than 1.5 or Prothrombin time greater than 40
* Chronic Kidney Disease or glomerular filtration rate less than 30 mL/min
Pediatric Resuscitation With Feedback CPR Devices

The aim of this study was to compare the TrueCPR feedback device (with metronome) to standard basic life support (BLS) in terms of the quality of single rescuer pediatric resuscitation. Therefore, our hypothesis was that there would be no difference between both CPR methods in terms of chest compression quality parameters.

Cardiac arrest is a leading cause of death worldwide. High-quality chest compressions are of paramount importance for survival and good neurological outcome. Unfortunately, even health professionals have difficulty performing effective CPR. Chest compression (CC) is often too shallow, compression ratio is inadequate, and hands-off time is too long. CPR feedback devices might be an option for rescuers to in order to increase CC efficiency.

Eligibility Criteria:
Inclusion Criteria:

* give voluntary consent to participate in the study
* medical profession (paramedics, nurses, physicians) or medical students (nurses, paramedics, physicians)

Exclusion Criteria:

* not meet the above criteria
* wrist or low back diseases
Real-time Continuous Glucose Monitoring in Very Low Birth Weight Neonates

Hypoglycemia is frequent in very low birth weight (VLBW) neonates and compromises their neurological outcome. The aim of this study was to compare real-time continuous glucose monitoring system (RT-CGMS) to standard method by intermittent capillary blood glucose testing in detecting and managing hypoglycemia. The investigators calculated a number of 48 neonates to be randomized between 2 ways of glucose level monitoring for their 3 first days of life : either by RT-CGMS (CGM-group), or by intermittent capillary glucose testing (IGM-group) associated with a blind-CGMS to detect retrospectively missed hypoglycemia. The investigators' hypothesis is that in the CGM group number and duration of hypoglycemia will be lower.


Eligibility Criteria:
Inclusion Criteria:

* Very low birth weight (VLBW) preterm infants (birth weight under 1500g) who were admitted before 24 hours of life in the Department of Neonatology of the University Hospital of Tours

Exclusion Criteria:

* a serious congenital abnormality,
* a skin condition that contraindicated continuous glucose monitoring,
* a transfer toward another hospital during the first days of life
* an absence of parental agreement.
Cement Excess at Single Implant Crowns Malmö/Lund

Abstract

Aim:

The primary aim of this study is to test whether or not cement residues in the submucosal environment of implants lead to a change in the microbiota and induce inflammation of the periimplant tissues.

Material and Methods:

24 patients in need of a single tooth replacement will be enrolled in this cross-over controlled clinical study. All patients will receive a two-piece dental implant, which will be restored with both a cemented and a screw-retained single crown. At the time of impression taking, patients will be randomized into two groups.

Patients in group A will receive a screw-retained crown. Every 8 weeks microbiological samples using sterile paper points will be collected and analyzed for bacterial content by real-time PCR. Additionally, two host markers (MMP8, IL-1ß) will be determined by ELISA. Following this first period of 16 weeks, the screw-retained crown will be replaced by a new intraorally cemented crown. Cement removal will be preformed according to best clinical procedure. These crowns will again be left for another period of 16 weeks and followed up for the harvesting of microbiological samples every 8 weeks. After the second 16-week the crowns will be removed to evaluate any excess cement. All patients will be fitted with the original screw-retained crown. Clinical parameters for inflammation and probing depths will be obtained after each 16 week-period.

In group B the crowns will be incorporated in a reverse pattern. During the first 16 weeks any possible cement residues will be removed according to best clinical procedure, while for the second period of 16 weeks patients will be fitted with a screw-retained single crown. Again, microbiological and clinical parameters will be obtained at the same intervals as in Group A.

After the second 16 week period the screw-retained crowns will be (re-) inserted in all patients, single tooth x-rays taken and clinical baseline values obtained. Additionally, a soft tissue biopsy will be harvested at the time of insertion of the final screw-retained crown. Patients will be followed up for another 16-week period.


Eligibility Criteria:
Inclusion Criteria:

* - patient older than 18 years
* systemically healthy subject
* periodontally healthy individuals
* absence of peri-implantitis
* no bone loss
* good oral hygiene (PCR ≤ 20%)
* healthy periodontal tissues (BoP≤ 20%)
* patients with a single tooth gap in the posterior area of either jaw (premolars and molars)
* at least 8mm in mandible; at least 6mm in maxilla (summers technique)

Exclusion Criteria:

* - ongoing periodontal disease
* bruxism
* unwilling to comply with study procedures
* heavy smokers (≥10 cig/d)
* ongoing periodontitis/implantitis
Impact of Somatosensory Intensive Intervention on Motor Performance in Children With Unilateral Cerebral Palsy

This study aims to investigate the effectiveness of an intensive somatosensory intervention in the upper limb of children with hemiparesis regarding structure, function, activity and participation

Hypothesis:

Intensive somatosensory activity based intervention is effective in upper limb and hand ability in children with hemiparesis, specially regarding activity and participation

Feasibility and longitudinal study with blinding of the evaluator and the person analyzing the data. The study have 4 procedures:

1. - Assessment pre-intervention
2. - Intervention: three weeks
3. - Assessment post-intervention
4. - Follow-up assessment (three months after intervention).

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of unilateral cerebral palsy
* Manual Ability Classification System (MACS): levels I, II y III.
* Gender: male and female
* Age: 6 to 15 years old

Exclusion Criteria:

* Existence of a moderate or severe cognitive impairment, which could interfere with the comprehension of the tester cues
* Botulinum toxic infiltration 4 months before the date of the pre-intervention assessment or during intervention or during the 3 months after the final intervention
* To have suffered any injury such as fractures and/or contusions in the upper limb in the last 12 months
* Orthopedic intervention in the 6 months preceding the study or during the study