cyrilzakka/clinical-trials huggingface dataset:
Infant Sleep Behaviour and Gut Microbacteria

The overarching study aim is to evaluate the development of sleep behavior and gut microbiota (GMB), and their potential interaction, during the vulnerable period of the first year of life. Age-specific fecal profiles with bacterial genome sequencing will provide new insight into the functional coevolution of the GMB and host sleep behavior.


Eligibility Criteria:
Inclusion Criteria:

* Good general health status
* exclusively breastfed (at baseline)
* vaginal birth delivery mode

Exclusion Criteria:

* C-section delivery mode
* Formula fed (at baseline)
* Diseases or lesions of the central nervous system, acute pediatric disease, developmental/neurologic/metabolic disorders, chronic medical conditions, or head injury
* Family history of narcolepsy/psychosis/bipolar disorder
* Conceptual age of \< 37 or \> 42 weeks
* Low birth weight (\< 2500g)
* Co-sleeping during \> 50% of the time in the same bed
* Medication use affecting sleep/alertness
* Vaccination (2 weeks prior to study)
* Antibiotics (3 months prior to study)
* Travelling across a time zone (within 1 month prior to study)
* intrauterine drug exposure, intrauterine infection, known or suspected drug or alcohol abuse
* Insufficient knowledge of German (parents)
The Effect of Posture Shirts on Posture During Functional Tasks

This study investigates the effect of a posture shirt on posture during functional tasks such as office work.

Poor posture have historically been blamed for pain and disability in the general population. A treatment-strategy that have gain popularity in recent years is the use of a posture shirt which is a compressive shirt designed and marketed to the general public and health service providers as a way to improve posture and consequently alter muscle activity, reduce musculoskeletal pain and discomfort. This study will investigate the effect of posture shirts on posture.

Eligibility Criteria:
Inclusion Criteria: - Healthy participants

* Pain free healthy participants
* Able to speak, read and understand Danish Exclusion Criteria: - Healthy participants
* Pain from the back, neck or shoulder area during the past 3 months
* Any discomfort in relation to computer use
* Lack of ability to cooperate
CIMT and Plaque Assessment Findings in Subjects Undergoing Stress Echocardiography For Risk Stratification

The purpose of this research study is to determine if carotid artery ultrasound scanning can provide additional information for determining cardiovascular risk in patients.

Patients who agree to participate wil undergo non-invasive carotid intima-media thickness (CIMT) measurement and plaque assessment. Findings of CIMT will be compared to results of patient standard of care stress echocardiogram (SE) and of diastolic function.

We hypothesize tht 1) in patients undergoing SE for inappropriate or uncertain indications, CIMT and plaque assessment will provide useful risk stratification beyond use of traditional risk factors; 2) CIMT findings will correlate with results of SE in terms of exercise capacity and 3) Exercise capacity will correlate with diastolic function.


Eligibility Criteria:
Inclusion Criteria:

* Asymptomatic
* No prior cardiac history (MI, PTCA, CABG, angina)
* No peripheral vascular disease
* No history of stroke or TIA
* Statins, antihypertensives, ASA treatment OK

Exclusion Criteria:

* History of CAD, CABG, PTCA, coronary or peripheral stenting
* History of stroke/TIA/peripheral vascular disease
* Inability to exercise on the treadmill
* Unwilling/unable to sign informed consent
* History of neck radiation or neck surgery or inability to obtain neck images
* End stage renal disease
* Preoperative evaluation
* History of chest pain
Effects of ELDOA Versus Post Facilitation Stretching Technique in Patients With Knee Osteoarthritis

This study aims to assess whether Elongation Longitudinaux Avec Decoaption Osteo Articulaire versus post assistance extending strategy have effects on knee torment. and to check its impact on actual capacity.

A randomized controlled trial will be conducted at Safi Teaching Hospital, Faisal Teaching Hospital and Allied Hospital Fsd after the synopsis has been approved. Patients will be enrolled using a simple random sampling technique. Patients with Knee Osteoarthritis will be chosen based on pre-established inclusion and exclusion requirements. Patients will receive Elongation Longitudinaux Avec Decoaption Osteo Articulaire, and post-facilitation stretching techniques. Two tools will be used to find out the comparison of both groups; Numeric Pain Rating Scale; for knee pain and Lower Extremity Functional Scale; to check the ability of the patient to perform the everyday task and for evaluation of functional impairments for patients with a disorder of lower extremities.

The assessment will need to be done at baseline and follow up will be 15 days after treatment. Each patient will be asked to give their informed consent. Statistical Package of Social Sciences Version 20 will be used for data entry and analysis.

Eligibility Criteria:
Inclusion Criteria:

* It includes both male and female diagnose with knee Osteoarthritis according to history, physical examination and radiological findings and also patient who score more than 3 on Numeric Pain Rating Scale
* Osteoarthritis grade of 3 and lower as determined by using Kallgran and Lawrence Radiographic classification.

Exclusion Criteria:

* If patient is unable to walk or exercise without functional aid and have previous knee surgery.
* Patient with heart condition.
Fifty Two Week Extension Trial of Org 50081 (Esmirtazapine) in the Treatment of Insomnia (P05708)

This trial is a 52-week, open-label extension trial to investigate safety and to explore efficacy of Org 50081 (Esmirtazapine) in participants who completed Protocol 176001 (P05706) (NCT00482612) or 176002 (P05707) (NCT00506389). Participants who have completed Protocol P05706 or P05707, and are willing to continue treatment with Esmirtazapine, can participate in Protocol 176004 (P05708) after signing informed consent.


Eligibility Criteria:
Inclusion Criteria:

* sign written informed consent after the scope and nature of the investigation have been explained to them, before any trial-related evaluations;
* completed Protocol P05706 or P05707;
* Have safety and efficacy assessments conducted per protocol P05706 or P05707.

Exclusion Criteria:

* clinically relevant electrocardiogram (ECG) abnormalities as judged by the investigator;
* clinically relevant abnormal laboratory values as judged by the investigator;
* any adverse event deemed relevant for exclusion in Protocol P05708 as judged by the investigator or,
* were significantly non compliant with protocol criteria and procedures of Protocol P05706 or P05707, as judged by the investigator.
ASA Prediction Using Health Data and Medication Use

The development of a machine learning algorithm that predicts American Society of Anesthesiologist-Physical Status (ASA-PS) based on preoperative variables would not only improve clinical decision-making in patient risk stratification but also offer a more reliable tool for administrative and regulatory uses. Therefore, the development of such a machine learning tool presents a significant opportunity to advance both the science and practice of perioperative care. Incorporating medication use into the algorithm could further enhance its predictive power, as it is closely linked to systemic disease. This addition could help refine the ASA-PS classification, making it an even more valuable tool in the clinical setting.

The American Society of Anesthesiologists Physical Status (ASA-PS) classification system is a widely used tool for assessing surgical fitness and other clinical contexts. However, its inherent subjectivity and heavy reliance on clinician judgment can lead to inconsistencies in patient risk stratification, a critical component of perioperative care. Furthermore, the ASA-PS system has been adopted for various administrative and regulatory purposes beyond its original intent, such as quality assessment by the Dutch Health and Youth Care Inspectorate (IGJ), compensation decisions by private payers in the USA, patient triage, and determining suitability for certain types of surgery.

Given the broad and critical applications of the ASA-PS system, enhancing its precision and objectivity is of paramount importance. One way to achieve this is through the development of a machine learning algorithm that predicts ASA-PS based on preoperative variables. Anesthesiologists base the ASA-PS score on the presence of systemic diseases, which can be inferred from medication use. By leveraging data such as Anatomical Therapeutic Chemical (ATC) codes, BMI, sex, age, routinely collected preoperative health data, and medication use, this algorithm could provide a more consistent and objective measure of ASA-PS.

This would not only improve clinical decision-making in patient risk stratification but also offer a more reliable tool for administrative and regulatory uses. Therefore, the development of such a machine learning tool presents a significant opportunity to advance both the science and practice of perioperative care. Incorporating medication use into the algorithm could further enhance its predictive power, as it is closely linked to systemic disease. This addition could help refine the ASA-PS classification, making it an even more valuable tool in the clinical setting.

Eligibility Criteria:
Inclusion Criteria:

* Underwent a surgical, diagnostic or therapeutic procedure within the surgical suite of the Erasmus MC, and
* ASA-PS score recorded in electronic medical record (EMR), and
* A verified medication list in EMR, or a filled out preoperative anesthesiological health questionnaire registered in EMR

Exclusion Criteria:

* Age \<18 at moment of surgery, or
* ASA-PS V-VI, or
* Opt-out registered in EMR
Effects of Desflurane-propofol Balanced Anesthesia on Visual Evoked Potentials Monitoring

Intraoperative flash visual evoked potentials (FVEPs) can be used to monitor the integrity of the visual pathway in real-time during surgeries, and is to prevent the damage and deterioration of visual function caused by visual pathway damage, which is the key method of intraoperative monitoring of visual function.

Spinal surgery in the prone position may compress the eyeball and reduce the blood supply of the ophthalmic artery, which is still one of the main causes of postoperative visual impairment. Intraoperative FVEPs monitoring is easily affected by inhale anesthetics, and there is little studies on the effect of intravenous-inhalation balanced anesthesia on FVEPs monitoring. Desflurane wakes up quickly, which is conducive to the recovery of early respiratory function and orientation, and early neurological evaluation. This study aims to compare the effects of desflurane-propofol balanced anesthesia and desflurane pure inhalation anesthesia on the amplitude and latency of FVEPs during spinal surgery under the same sedation depth monitored by bispectral index (BIS) monitoring.


Eligibility Criteria:
Inclusion Criteria:

1. Patients undergoing spinal cord surgery under elective general anesthesia;
2. At the same time, other electrophysiological monitoring is required;
3. 18-65 years old;
4. ASA I-III;
5. Sign the informed consent form.

Exclusion Criteria:

1. Patients with visual impairment;
2. Patients with severe liver and kidney function diseases;
3. History of asthma; Uncontrolled hypertension, diabetes, severe arrhythmia or unstable angina pectoris;
4. Have mental illness or unable to communicate;
5. BMI≥30kg/m2；
6. Abuse of analgesics and drug abuse history;
7. Silicone allergy;
8. Visual evoked potential monitoring was rejected.
Randomized Controlled 8-week Crossover Evaluation of Compression Bandage Systems for Venous Leg Ulcers

The purpose of this study is to evaluate the product performance of a new 2-layer compression bandage for the treatment of venous leg ulcers.

The purpose of this study is to evaluate the product performance of a new 2-layer compression bandage for the treatment of venous leg ulcers. The new bandage is a 2-layer compression system. It will be used over primary dressings to provide the compression that is beneficial to venous leg ulcers.

Eligibility Criteria:
Inclusion Criteria:

* venous leg ulcer
* patient can walk

Exclusion Criteria:

* cancerous ulcers
* diabetic foot ulcer
Treatment of Hypersensitivity Using Diode Laser and Desensitising Agent on Fluorosed and Non-fluorosed Teeth

The present study was designed as a randomised controlled clinical trial which was unicenter, double-blinded, parallel designed study, according to the Consolidated Standards of Reporting Trials (CONSORT) criteria, 2010. The study period was from July 2014 to September 2015.

90 Patients visiting the Out Patient of Department of Periodontology, Krishnadevaraya College of Dental Sciences and Hospital, Bengaluru, India, presenting with a chief complaint of dentinal hypersensitivity were enrolled in the study. Patients' age ranged from 18-60 years. The subjects interested in participating were explained in detail the treatment protocol. A verbal consent as well as a written informed consent was obtained from each patient Treatment of dentinal hypersensitivity with a combination of diode laser and potassium nitrate desensitising agent was considered as the test group and this was compared with diode lasers alone and desensitising agent alone as the positive control groups. The study was conducted in full accordance with the declared ethical principles (World Medical Association Declaration of Helsinki, version VII, 2013)13 and was approved by the Institutional review board of Krishnadevaraya College of Dental Science and Hospital, under the registration number of (ACA/DCD/SYN/KCODS - B/PG/2013-2014).

Eligibility Criteria:
Inclusion Criteria:

* • Patients with a positive response for hypersensitivity testing (Pashley, 1990) i.e. cold water testing using ice cold water (Trowbridge et al., 1980),

  * Air blow test (Coleman and Kinderknecht, 2000),
  * Electric tactile stimulation test (Camps and Pashley, 2003),
  * Patients presenting with non-carious cervical lesions in the enamel (Loomba et al., 2013), fluorosed teeth wherein fluorotic enamel staining confirmed by clinical examination, healthy non fluorosed teeth, which was confirmed by clinical examination (Dean, 1934).

Exclusion Criteria:

* The following were set as the exclusion criteria;

  * Patients undergoing any form of restorative endodontic,
  * Orthodontic treatment or crown restorations,
  * Local defects including caries and fractures,
  * Presence of any systemic diseases,
  * Acute pain conditions (like apical periodontitis, periapical abscess),
  * Presence of periodontal disease or a history of periodontal treatment in last 6 months,
  * Usage of desensitising toothpaste or mouth rinse in the last 4 weeks,
  * Patients allergic to ingredients used in the study product,
  * Teeth with intrinsic stains caused by other reasons.
Probiotic Supplementation Reduces Gastrointestinal Symptoms During the Therapy and Improves Therapeutic Response in AL Amyloidosis

The purpose of this clinical trial is to evaluate whether specific probiotic can reduce gastrointestinal symptoms and improves therapeutic response, on a background of Bortezomib+dexamethasone or Bortezomib+dexamethasone combined with daratumumab therapy, for naive AL amyloidosis patients.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* Biopsy-proven naive AL amyloidosis
* Receive at least 1 course of treatment based on Bortezomib+Dexamethasone or Bortezomib+Dexamethasone+Daratumumab therapy
* At least 1 organ (heart, kidney, liver, etc) involved
* Agree to participate in the project and sign the informed consent.

Exclusion Criteria:

* Received antibiotics for 3 consecutive days and on in the past 2 months prior to the enrollment
* Had history of probiotics, prebiotics, immunosuppressants, hormones, and other medications use in the past 3 months that influence the Gastrointestinal Microbiome
* Had other underlying diseases（malignancy or immune system diseases, etc.）
* Had history of clearly diagnosed chronic gastrointestinal disease
* Secondary AL amyloidosis or local AL amyloidosis
* Other conditions the researcher judged unsuitable for enrollment
Soy and Lipoproteins in Postmenopausal Women

To determine the effects of soy on lipids, lipoproteins and lipoprotein subclass in a sample of African-American and white postmenopausal women with low-density lipoprotein (LDL) cholesterol elevations that may increase their lifetime risk for cardiovascular disease but would not qualify for definite pharmacotherapy under current guidelines.

BACKGROUND:

Cardiovascular disease (CVD) remains the leading cause of mortality and disability in postmenopausal women. Menopause alters serum lipids and lipoproteins to produce a more atherogenic lipid profile that may contribute significantly to the increased risk for the development of CVD over the lifetime of women. Clinical trials have demonstrated a beneficial effect of soy protein containing isoflavones (soy) on plasma lipids and lipoproteins; however, these studies included small numbers of postmenopausal women and virtually none included sufficient African-American women. In addition, no published data existed in 2001 on the impact of soy on atherogenic lipoprotein subclasses in postmenopausal women.

DESIGN NARRATIVE:

The study was a double blind, parallel group, randomized clinical trial. A total of 216 healthy postmenopausal women (50 percent African-American) with LDL cholesterol between 130 mg/dL and 190 mg/dL were enrolled. Following a pre-randomization run-in period on a NCEP Step I diet, women were randomized to receive soy containing isoflavones or casein dietary supplements for 3 months. Major outcome variables were assessed in both groups at baseline and again at 3 months. It was hypothesized that soy supplementation would result in significantly greater reduction in LDL cholesterol, LDL particle concentration, and prevalence of dense LDL particles and improvement in menopausal quality of life compared with placebo and that these effects would be comparable in African-Americans and whites. This was the first study to determine whether a natural plant product could ameliorate the unfavorable changes in known and novel lipid risk factors that are a consequence of menopause in both African-American and white women. The unique transitional outcomes explored in this study added substantially to the limited body of knowledge of the effects of soy. Evaluation of this nutritional alternative to hormone replacement therapy (HRT) that may provide a beneficial effect on lipid risk factors and menopausal symptoms but would be free of the adverse effects on triglycerides, the breast and uterus, and thrombotic events associated with HRT could have significant public health implications for postmenopausal women.

Eligibility Criteria:
Inclusion criteria

* postmenopausal women
* elevated cholesterol
Optimized PGT-M Strategy for Patients with No Proband

The clinical practice of PGT-M for monogenetic disease usually adopted a double-checking strategy, which detect the mutation by Sanger sequencing and meantime construct haplotypes using the DNA sample of the proband so as to avoid the risks of misdiagnosis due to recombination and allele drop out (ADO). When there is no affected parent or offspring to serve as the proband, embryo carriers identified through direct mutation detection can be preferentially taken as probands for subsequent linkage analysis. In cases where none of the embryos are detected as mutant carrier, single sperm or the second polar body (PB2) can be complementally collected in the work-up of haplotype establishment. Our study aims to develop an optimized strategy of haplotype construction using gametes or arrested embryos for PGT-M in pedigrees with single gene diseases and no proband in the setting of difficult cases, which takes into account the expected number of oocytes acquired and the gonadal mosaicism.


Eligibility Criteria:
Inclusion Criteria:

* The couples intended for PGT-M without proband were recruited from Shanghai JiAi Genetics and IVF Institute, Obstetrics and Gynecology Hospital of Fudan University between January 2023 and December 2024, and were included in the study if they were expected to have difficulties in the identification of an EAP, typically meeting one of the following criteria:

  1. the carrier of the pathogenic variant was without typical clinical symptoms or detected as gonadosomal mosaic;
  2. the asymptomatic parents, who had one or more children affected with the same disorder, did not possess the genomic alterations carried by the children as per Sanger sequencing or targeted deep sequencing;
  3. female partner with diminished ovarian reserve and therefore a low yield of embryos;
  4. the variants are X-linked and the karyotype of the variant carrier is 47, XXX or 47, XXY etc.

Exclusion Criteria:

* (1) Non-PGT-M families; (2) Pedigree of other proband samples can be obtained; (3) Patients seeking for PGT-M who strongly request no haplotype analysis in embryos and only require Sanger testing after being fully informed of the risk.
Spasticity and Treatment Satisfaction Among Stroke Survivors

To investigate, through ethnography, changes in symptom burden and disability and their effects/interference on patient functioning, ability to perform activities of daily living (ADL) and quality of life (QoL) throughout the duration of one BoNT-A treatment cycle.


Eligibility Criteria:
Inclusion Criteria:

* Diagnostic of post-stroke spasticity more than three months prior to inclusion
* At least 6 months on treatment (or two treatment cycles) with BoNT-A injections for spasticity according to the decision of the physician
* Previous BoNT-A injection cycles did not last for more than 16 weeks
* Ambulatory (use of walking aids is acceptable)

Exclusion Criteria:

* Neurological disorder other than stroke
* Spasticity-specific treatment changes within 3 months prior to inclusion
* Patients who had undergone neurolysis or surgery to the affected limb within 6 months
* Concurrent participation in a clinical trial for the treatment of spasticity