cyrilzakka/clinical-trials huggingface dataset:
Incidence, Risk Factors and Impact of Significant Pain in Patients Undergoing Neurosurgery

The proposed study intends to evaluate incidence of postoperative pain after neurosurgery. This study is likely to help in understanding of the magnitude of this problem in our country and inform about possible predictors which will help institute pre-emptive interventions to mitigate modifiable risk factors of pain after neurosurgery.

Data regarding potential risk factors for postoperative pain will be collected. Preoperative factors (preoperative pain, anxiety or depression, perception about surgery, age, gender, socio-economic status, educational level, domicile location, obesity, surgical site \[infratentorial or supratentorial or cervical, thoracic or lumbar\], use of steroids and analgesics), and intraoperative factors (scalp/ESP/caudal block, incision site infiltration, dose of analgesics such as opioids, paracetamol and non-steroidal anti-inflammatory drugs (NSAIDs), co-analgesics such as nitrous oxide, gabapentionoids, dexmedetomidine, magnesium or lignocaine infusion, anti-epileptics, steroids, minimum alveolar concentration (MAC) of inhalational anesthetics, and duration of surgery and anesthesia) that are likely to be associated with occurrence of postoperative pain will be explored along with relationship between acute and persistent postoperative pain and between intraoperative nociception and postoperative pain.

Eligibility Criteria:
Inclusion Criteria:

* all eligible consecutive consenting adult patients aged \> 18 years with preoperative Glasgow Coma Scale (GCS) score of 15 undergoing elective craniotomies and spine surgeries

Exclusion Criteria:

* children, patients with GCS \< 15, patients not extubated within 2 hours of end of anesthesia and those who not able to respond to our questions on outcomes
Clinical Feasibility and Evaluation of Silicon Photon Counting CT

The purpose of the study is to collect data to evaluate utility of the using photon-counting CT in a clinical setting.

Data collected in this study includes an assessment of image quality parameters including spatial resolution, image contrast, and noise that will evaluate the product and how this photon-counting CT technology can be used to reduce the overall radiation dose in CT imaging, and enhance clinical applications for CT technology. This data and analysis will help support regulatory submission.

Eligibility Criteria:
Inclusion Criteria:

* Who are 18 years of age or older
* Able to sign and date the informed consent form
* Who have in the past 120 days or will in the future 30 days undergo a clinically-indicated CT exam of the head, neck, heart, chest, abdomen, pelvis, or extremities where images are available for this prior scheduled exam

Exclusion Criteria:

* Who are pregnant or lactating;
* Who were previously enrolled in this study;
* For contrast-enhanced CT exams, anyone with known or suspected allergy to iodinated contrast agents
* For contrast-enhanced CT exams, anyone with known or suspected renal insufficiency as determined by site medical personnel;
* Who need urgent or emergent care;
* Who have any conditions that, in the opinion of the PI or designee, would interfere with the evaluation of the results or constitute a health hazard for the subject; OR
* Who are unwilling to have GEHC personnel present for the CT exam.
Performance of Mid-Upper Arm Circumference for Detection of Severe Acute Malnutrition in Indonesian Under-Fives

WHO recommends 11.5 cm as a cut-off point of Mid-Upper Arm Circumference (MUAC) to detect and/or diagnose severe acute malnutrition (SAM) in under-five. MUAC is practical and useful, especially in area with limited facilities which has no standardized scale and infantometer. However, several studies showed that this cut-off need to be evaluated as it has modest detection rate for SAM. This study aims to evaluate diagnostic value of MUAC with 11.5 cm cut-off compared to WHZ as gold standard to identify SAM. The sensitivity, specificity, positive and negative predictive value of MUAC with 11.5 cm as a standard cut-off will be evaluated.

This study also aim to find new cut-off value that may offer better diagnostic performance. The main research questions were:

What is the diagnostic accuracy of Mid-Upper Arm Circumference (MUAC) compared to the Weight for Height Z Score (WHZ) in identifying SAM in children, and what is the optimal MUAC cut-off value for enhanced diagnostic performance?


Eligibility Criteria:
Inclusion Criteria:

* under-fives that 6-59 months-old

Exclusion Criteria:

* ascites
* edema
* hydrocephalus
* tumor or oncologic diseases
* organomegaly
* uncooperative during measurement
China Kidney Patient Trials Network

This is a prospective multi-centre, observational cohort study of incident and prevalent patients diagnosed with a kidney disease in China.


Eligibility Criteria:
Inclusion Criteria:

1. Documented diagnosis of primary kidney disease
2. Regular visits (at least 6 monthly) with a physician at a participating site
3. eGFR \> 15 ml/min/1.73 m2
4. ≥ 2 years of age
5. Willing and able to sign informed consent
6. Willing to be approached about participation in interventional research studies

Exclusion Criteria:

* 1. Life-expectancy of less than 6 months
Analysis of Clinical Characteristics and Study of Diagnostic Markers in Patients with Polycystic Ovary Syndrome

The investigators collected clinical data and serum samples of patients with polycystic ovary syndrome in this study, used statistical software such as SPSS for data analysis, and used experimental techniques such as ELISA to detect serum samples, aiming to explore the relationship between the body anthropometry, glucose and lipid metabolism, gonadal hormones and body fat distribution in patients with polycystic ovary syndrome and to discovery new biomarkers and promote the realization of more accurate personalized medicine.


Eligibility Criteria:
Inclusion Criteria:

* Female aged 18- 45;
* Meet Rotterdam criteria;

Exclusion Criteria:

* Women who are pregnant or have a pregnancy plan within six months;
* Congenital adrenocortical hyperplasia;
* Hyperprolactinemia;
* Hyperthyroidism or hypothyroidism;
* Abnormal liver function (≥ 3 times of the upper limit of normal range);
* Abnormal renal function (GFR\<60ml/min/1.73m2);
* Adrenal or ovarian tumors secreting androgens;
* Used contraceptives, metformin, GLP-1RA, pioglitazone and contraceptives in the last 3 month.
Impact of New Standards for Tobacco Products Among Dual E-Cigarette/Combusted Cigarette Users - Project 2

The purpose of the study is to evaluate how limiting the nicotine content in regular cigarettes affects choices for regular cigarette and e-cigarette products. Eligible participants will be of legal age to purchase tobacco products and regularly use both e-cigarettes and regular cigarettes.

Participants in this study will undergo an in-person screening session where the study will be explained in detail and participants will answer questions and provide a breath sample. During the screening session, participants will also be asked to complete surveys. Eligible participants will then complete the training procedures during which they will select an e-cigarette device to use for future preference sessions. During the 4 preference sessions, participants will sample puffs from an e-cigarette and regular cigarette and answer questions about their experience with each. They will also complete a task during which they can choose to earn puffs from the e-cigarette or regular cigarette, or choose to not take any puffs. The 4 sessions will be the same except that a different combination of e-cigarette and regular cigarette is used at each session.

Eligibility Criteria:
Inclusion Criteria:

1. Legal age to purchase tobacco products;
2. Regular user of EC and CC;
3. Owns the e-cigarette device used most often;
4. Agrees to abstain from using all tobacco products for 12 hours prior to each experimental session;
5. Self-reporting tobacco flavored e-liquid is preferred or usual flavor e-liquid

Exclusion Criteria:

1. Unstable medical conditions as determined by the licensed medical professional;
2. Unstable psychiatric conditions as determined by the licensed medical professional or PI;
3. Currently pregnant, breastfeeding, trying to become pregnant or unwilling to agree to use adequate protection to avoid pregnancy;
4. Serious quit attempt of either or both products in the past 3 months resulting in \>30 days of abstinence;
5. Currently using nicotine replacement therapy or other pharmacotherapies as cessation aide;
6. Plans to quit use of either EC or CC, or all tobacco products in the next 45 days;
7. Self-reporting nicotine-free, CBD, or THC liquid is preferred or usual e-liquid;
8. Vital signs outside of the following range (participants failing for vital signs will be allowed to re-screen once):

   1. Systolic blood pressure (BP) greater than or equal to 160 mm/hg
   2. Diastolic BP greater than or equal to 100 mm/hg
   3. Heart rate greater than or equal to 115 bpm;
9. Allergy to propylene glycol or vegetable glycerin;
10. Previous adverse reaction when using vaping device or e-liquid;
11. Current or recent alcohol or drug abuse problems;
12. Previous use of SPECTRUM or other reduced nicotine content cigarettes in past 3 months;
13. Literate and able to independently complete and comprehend the consent form and other written study materials and measures.
Understanding of Participation Trends Within Generalized Anxiety Disorder Patients Involved in Clinical Trials

Typically, certain demographic groups tend to participate more in medical research. However, there is insufficient research explaining the trial characteristics that influence the involvement of these specific demographics.

This study aims to collect extensive data on the clinical trial experiences of individuals with generalized anxiety disorder. The goal is to identify the factors that hinder a patient's enrollment or completion of a trial.

Additionally, the research will examine the data from various demographic perspectives to identify recurring patterns that could offer valuable insights for future generalized anxiety disorder patients.


Eligibility Criteria:
Inclusion Criteria:

* Confirmed diagnosis of generalized anxiety disorder
* Participant must be 18 years of age or older
* Participant must be willing and able to comply with scheduled visits, treatment schedule, laboratory tests, and other requirements of the study.

Exclusion Criteria:

* Pregnant or lactating woman
* Participant is actively receiving study therapy in another
* Inability to provide written informed consent
Low-Dose Radiotherapy in Treating Painful Bone Metastases in Patients With Multiple Myeloma

This phase II trial studies how well low-dose radiotherapy works in treating bone pain in patients with multiple myeloma that has spread to the bone. Radiation therapy uses high energy x-rays, gamma rays, neutrons, protons, or other sources to kill tumor cells and shrink tumors. Low-dose radiotherapy may be more convenient for patients and their families, may not interfere as much with the timing of chemotherapy, and may have less chance for short term or long-term side effects from the radiation.

PRIMARY OBJECTIVES:

I. To determine whether treatment with 2 Gy x 2 to a painful myeloma bone lesion achieves patient-reported pain reduction comparable to current standard of care at 4 weeks.

SECONDARY OBJECTIVES:

I. To assess quality of life (QOL) in patients treated with 2 Gy x 2 to painful myeloma bone lesions.

II. To quantify analgesia use/reduction following 2 Gy x 2 to a painful myeloma bone lesion. All opioid analgesia use will be converted into morphine equivalent in order to compare across the entire population.

III. To measure time to pain relief and duration of pain relief with 2 Gy x 2.

EXPLORATORY OBJECTIVES:

I. To record cytogenetics and International Myeloma Working Group (IMWG) response criteria at diagnosis and prior to and following radiotherapy (RT).

OUTLINE:

Patients receive low-dose radiation therapy at consecutive business days 1 and 2 in the absence of disease progression or unacceptable toxicity. Patients with no pain relief may receive additional radiotherapy at 4 weeks following initial radiotherapy.

After completion of study treatment, patients are followed up at 2, 4, and 8 weeks and also at 6 months.

Eligibility Criteria:
Inclusion Criteria:

* Histologic diagnosis of multiple myeloma
* Painful bone metastasis (index lesion) that has a radiographic correlate
* Patient may have had any number of prior chemotherapy/immunotherapy regimens (changes to systemic therapy or use of bisphosphonates for 4 weeks before and after RT are allowed, but recording of these changes must be made so it can be accounted for)
* Eastern Cooperative Oncology Group (ECOG) 0-2
* Brief Pain Inventory (BPI) score \>= 2
* Ability to understand and the willingness to sign a written informed consent

Exclusion Criteria:

* Patients will be ineligible if the index lesion has received prior radiation therapy or prior palliative surgery. Patients may have received prior palliative or primary radiotherapy or surgery to other parts of the body, as long as the index lesion was not in the prior radiation fields and has not received prior palliative surgery
* Patients will also be ineligible if there is pathologic fracture or impending fracture at the site of the index lesion or planned surgical fixation of the bone at the index lesion
* Patients with clinical or radiographic evidence of spinal cord or cauda equina compression/effacement from the index lesion, and/or with index lesions located at the skull base or orbital lesions
* Patients must not be pregnant
Influence of a High Fat Breakfast in the Pharmacokinetics of UH-AC62MU in Healthy Subjects

Influence of a high fat breakfast in the pharmacokinetic profile of the 7.5 mg meloxicam rapid releases tablet


Eligibility Criteria:
Inclusion Criteria:

* Healthy subjects as determined by results of screening
* Written informed consent according good clinical practice (GCP) and local legislation
* Age \>=18 and \<=50 years
* Broca \>= -20% and \<= +20%

Exclusion Criteria:

* Any finding of the medical examination (blood pressure, pulse rate and electrocardiogram (ECG)) deviating from the normal and of clinical relevance
* Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorder
* Surgery of gastro-intestinal tract (except appendectomy)
* Disease of central nervous system (such as epilepsy) or psychiatric disorders or neurological disorder
* History of orthostatic hypotension, fainting spells or blackouts
* Chronic or relevant acute infections
* History of allergy/hypersensitivity (including drug allergy) which deemed relevant to the trial as judged by the investigator
* Intake of drugs with a long half-life ( \>24h) (\<=1month prior to administration)
* Use of any drugs which might influence the results of the trial (\<=10 days prior to administration or during the trial)
* Participation in another trial with an investigational drug (\<= 2 months prior to administration or during the trial)
* Smokers ( \>10 cigarettes or \>3 cigars or \>3 pipes/day)
* Inability to refrain from smoking on trial days
* Alcohol abuse (\>60g/day)
* Drug abuse
* Blood donation (\<= 1 month prior to administration or during the trial)
* Excessive physical activities (\<= 5 days prior to administration or during the trial)
* Any laboratory value outside the reference range of clinical relevance
* History of hemorrhagic diatheses
* History of gastro-intestinal ulcer, perforation or bleeding
* History of bronchial asthma

For female:

* Pregnancy
* Positive pregnancy test
* No adequate contraception e.g. sterilization, intrauterine device (IUD), oral contraceptives
* Inability to maintain this adequate contraception during the whole study period
* Lactation period
Sahlgrenska Cardiomyopathy Project

This is a joint project by Sahlgrenska University Hospital: Sahlgrenska, Östra and Mölndal.

Our objective is to diagnose and map patients with well phenotyped cardiomyopathies (CMP) including in depth clinical and molecular phenotyping to enable earlier and specific treatment. The project will serve as:

1. resource for diagnostic and therapeutic trials
2. common biomaterial bank
3. resource for detailed molecular analyses on patients' biomaterials and patient specific symptoms and examination results


Eligibility Criteria:
Inclusion Criteria:

* Patients with primary cardiomyopathies including hereditary and inflammatory dilated cardiomyopathy, hypertrophic cardiomyopathy, restrictive cardiomyopathy, left ventricular non-compaction cardiomyopathy, arrhythmogenic right ventricular cardiomyopathy, myocarditis, giant cell myocarditis, sarcoidosis and amyloidosis engaging the heart

Exclusion Criteria:

* Patient with other preexisting cardiac diseases such as significant valvular, ischemic or pericardial disease before they receive a cardiomyopathy diagnose
* patients \< 18 years
Assessing Patient Comfort With Two Different Multi-Purpose Disinfecting Solutions

Tolerability is compared between two Multi-purpose disinfecting solutions (MPDS).

According to recent surveys of contact lens fitters, the most prescribed treatments for contact lens dryness are: more frequent replacement schedule (24%), refit into different material (23%), rewetting drops (21%) and change care system (15%). Changing care systems has been a standard treatment for CL discomfort for many years. In the same survey, 30% of practitioners felt there is absolutely no difference among solutions with respect to reducing dryness and discomfort.

The investigators set out to compare the clinical performance of these two solutions: AMO's RevitaLens and Alcon's Opti-Free PureMoist.

Eligibility Criteria:
Inclusion Criteria:

1. Between the ages of 18 and over inclusive.
2. Males or females
3. Patient is in generally good \& stable overall health.
4. Patient likely to comply with study guidelines \& study visits.
5. Informed consent signed.
6. Are willing/able to return for all required study visits.
7. Are willing/able to follow instructions from the study investigator and his/her staff.
8. Have signed informed consent approved by Institutional Review Board or Independent Ethics Committee.

Exclusion Criteria:

1. Corneal refractive surgery within 6 months of this study.
2. Intra-ocular surgery within 6 months or ocular laser surgery within 6 months.
3. Ocular pathology (includes glaucoma and cataract), which could impact results and/or place patient at risk.
Study to Assess the Safety & Reactogenicity of GSK Biologicals' DTPa/Hib Vaccine When Given at 3, 4 and 5 Months of Age

This study will evaluate the safety and reactogenicity of GSK Biologicals' Diphtheria Tetanus acellular Pertussis/Haemophilus influenzae type b vaccine given to Chinese infants at 3, 4 and 5 months of age.


Eligibility Criteria:
Inclusion Criteria:

* A male or female between, and including, 90 and 120 days of age at the time of the first vaccination Written informed consent obtained from the parent or guardian of the subject

Exclusion Criteria:

* subjects with known exposure to diphtheria, tetanus, pertussis and/or Haemophilus influenzae disease can not participate, subjects who have received previous vaccination against diphtheria, tetanus, acellular pertussis and/or Haemophilus influenzae type b (Hib) diseases can not participate.
An Intervention to Reduce Inappropriate Medications in Long-term Care Residents With Severe Dementia

An education intervention to promote medication reviews and interdisciplinary discussions within long-term care facilities with the aim of improving medication regimen among residents with severe dementia

A quasi-experimental study in three long-term care facilities. The intervention comprises an information leaflet for families of residents, a 90-minute knowledge exchange session for general practitioners, pharmacists and nurses and a list of "generally", "sometimes", and "exceptionally" appropriate medications for severe dementia residents

Eligibility Criteria:
Inclusion Criteria:

* diagnosis of dementia of any etiology
* severe dementia

Exclusion Criteria:

* admission less than 2 months before intervention
Prehabilitation and Posttransplant Training Program in Liver Transplantation

PreLiveR-T consists of a prospective randomized clinical trial conducted in an adult population that is a candidate for liver transplantation (LT) at the Hospital La Fe Valencia (Spain). The study is structured in three phases: I) Prehabilitation (2 months before LT); II) Training, divided in two successive periods: Supervised training (months 3-6 after LT) and Unsupervised training (6-12 months after LT); III) Long-term follow-up (2 years after LT).

Primary outcomes are related to post-surgery evolution (morbidity and mortality, hospitalization length, etc.). As a secondary outcomes are collected those related to: functional capacity, muscle strength and quality of life.

The main objective is to study the post-surgical impact (post-S) of a Prehabilitation program on candidates for liver transplantation (LT), as well as to study the effects of posttransplant training on the clinical and functional evolution of the recipients. Also this project pretends to assess the influence of functional capacity (FC) improvement on the short and long term post-S evolution of the LT candidates. This is a prospective randomized clinical trial in which three phases follow: Prehabilitation, training and follow-up. The sample will be constituted by 60 candidates for LT, randomized in a control group (CG, n=20), a Prehabilitation group (PG, n=20) and a Prehabilitation-posttransplant training group (PTG, n=20). To conventional care, a Prehabilitation program will be added to the PG and PTG. After the LT, just PTG will follow a posttransplant training program. The long-term follow-up will be extended to 2 years post-LT. The variables under study will be: complications and post-S evolution; FC; quality of life; etc. The individualization of Prehabilitation and posttransplant training program, and also medical control, will ensure safety and offer the potential benefits that these types of programs can provide.

Eligibility Criteria:
Inclusion Criteria:

* Indication of elective liver transplant with favorable cardiorespiratory evaluation that does not contraindicate the transplant.

Exclusion Criteria:

* Any orthopedic, motor, functional, neurological, cognitive or linguistic limitation that prevents the realization of the Prehabilitation program
* Inability to perform psychometric tests
* Esophageal varices not treated with ligature or beta-blockers
* Varicose veins with a high risk of digestive hemorrhage
* Hemoglobin \<80 g/l
* Contraindication to weight loading
* Impossibility to comply with the Prehabilitation program (hospital admission, work, geographical location)
* Multi-organ transplantation and liver retransplantation
* Refusal or lacks capacity to give informed consent