cyrilzakka/clinical-trials huggingface dataset:
Mild Hypothermia Influence on Patient Outcome in Major Abdominal Surgery

This study investigate associations between mild hypothermia (patients' core temperature ≤ 36.0 degrees Celsius) and intra-operative blood loss and surgical site infections (SSI) in patients undergoing major abdominal surgery.

This study evaluates associations between patients' core temperature during surgery and intra-operative blood loss, and to SSI. Additionally, the investigators observe the use of hypothermia prevention measures in operating theaters, use of surgical safety checklists. SSI is registered at discharge from hospital and up to 30 days post-discharge.

The goal of the study is to contribute to focus on prevention of even mild hypothermia in surgery.

This study is of interest for healthcare personnel as operating room nurses, surgeons, nurse anaesthetists, anaesthesiologists, ward nurses, post anaesthetic care unit nurses, and other healthcare staff involved in the in-hospital surgical pathway.

Eligibility Criteria:
Inclusion Criteria:

* Patients (men or women) above 18 years, undergoing abdominal or gynecological surgery with laparotomy or laparoscopy.

Exclusion Criteria:

* Surgical procedures with intentional reduction of core temperature. Patients under the age of 18.
Arresting Carious Lesions With Minimal Intervention Techniques

A single-blinded randomized clinical trial with a split-mouth design that will assess the 12-month clinical and radiographic success of two minimally invasive treatment techniques, one using a chemo-mechanical caries removal agent and one using a caries arresting agent, for the treatment of deep caries in primary molars.

Fifty children (100 teeth) aged 4 to 8 years with a non-contributary medical history and at least two carious primary molars (ICDAS 5 and 6) on different quadrants will be randomly assigned to either treatment group, using computer-generated numbers.

Each cavitated lesion will be isolated with cotton rolls and air-dried before being treated with one of the two types of minimal intervention technique according to the manufacturer's instructions. After the application of the agents all teeth will be restored using a high viscosity glass ionomer cement.

Patients will be followed clinically at 6 and 12 months and radiographically at 12 months to evaluate success of the procedures.

Eligibility Criteria:
Inclusion Criteria:

* Children aged 4 to 8 years with a non-contributary medical history and sufficient compliance for the caries treatment will be included. The eligible children should have at least two carious primary molars (cavitated lesions up to 2/3 of dentin, corresponding to ICDAS 5 and 6) on different quadrants without any periapical pathology detected radiographically.

Exclusion Criteria:

* Children aged below 4 years and above 8 years, with compromised medical history and/or allergies, with clinical or radiographic signs or symptoms of pulp pathology and with developmental dental defects will be excluded.
Therapeutic Plasma Exchange in Thyrotoxicosis

Therapeutic plasma exchange (TPE) is indicated in cases where antithyroid medications cannot be used due to the side effects or attain no adequate hormonal suppression response at the highest dosage and in cases of rapid onset of clinical symptoms. This study presents the treatment results of patients who underwent TPE and subsequently operated for thyrotoxicosis.

Background: Therapeutic plasma exchange (TPE) is indicated in cases where antithyroid medications cannot be used due to the side effects or attain no adequate hormonal suppression response at the highest dosage and in cases of rapid onset of clinical symptoms. This study presents the treatment results of patients who underwent TPE and subsequently operated for thyrotoxicosis.

Methods: The files of 27 patients who underwent preoperative TPE for thyrotoxicosis between January 1999 and February 2019 were retrospectively analyzed. The demographic and clinical features of the patients were included.

Eligibility Criteria:
Inclusion Criteria:

* thyrotoxicosis unresponsive to medication
* adverse reaction to the medications
* need for rapid treatment in patients that need urgent surgery

Exclusion Criteria:

* The patients who did not undergo surgery post-therapeutic plasma exchange
* Preoperative hypocalcemia,
* hemodynamically unstable patients
* patients not suitable for central catheter placement
An Open-Label Study of Oral NNZ-2591 in Pitt Hopkins Syndrome (PTHS-001)

A study of the safety, tolerability and pharmacokinetics of NNZ-2591 and measures of efficacy in children and adolescents with Pitt Hopkins Syndrome.

The primary purpose of this study is to investigate the safety, tolerability and pharmacokinetics of treatment with NNZ-2591 oral solution in children and adolescents with Pitt Hopkins Syndrome. The secondary purpose is to investigate measures of efficacy. Subjects will receive treatment with NNZ-2591 oral solution (50 mg/mL) doses for a total of 13 weeks.

Eligibility Criteria:
Inclusion Criteria:

1. Clinical diagnosis of PTHS with a documented disease-causing genetic etiology for the disorder.
2. Males or females aged 3-17 years.
3. Body weight of 12kg or higher at screening
4. Subjects with a Clinical Global Impression- Severity (CGI-S) score of 4 or greater at the Screening visit.
5. Not actively undergoing regression or loss of skills, defined as no persistent loss of previously acquired developmental skills for a period within 3 months of the Screening visit
6. Each subject must be able to swallow the study medication provided as a liquid solution.
7. Caregiver(s) must have sufficient English language skills.

Exclusion Criteria:

1. Body weight \<12kg at screening
2. Clinically significant abnormalities in safety laboratory tests and vital signs at Screening.
3. Abnormal QTcF interval or prolongation at Screening.
4. Any other clinically significant finding on ECG at the Screening visit.
5. Positive for severe acute respiratory syndrome coronavirus 2 (SARSCoV-2) and previous COVID 19 infection with last 12 months that required hospitalization.
6. Unstable or changes Psychotropic treatment 2 weeks prior to screening
7. Excluded concomitant treatments.
8. Actively undergoing regression or loss of skills.
9. Unstable seizure profile.
10. Current clinically significant renal conditions and abnormalities
11. Current clinically significant cardiovascular, hepatic, gastrointestinal, respiratory, endocrine disease, or clinically significant organ impairment.
12. Current clinically significant hypo- or hyperthyroidism, Type 1 or Type 2 diabetes mellitus requiring insulin (whether well controlled or uncontrolled), or uncontrolled Type 1 or Type 2 diabetes.
13. Has planned surgery during the study.
14. History of, or current, cerebrovascular disease or brain trauma.
15. History of, or current catatonia or catatonia-like symptoms.
16. History of, or current, malignancy.
17. Current major or persistent depressive disorder (including bipolar depression).
18. Significant, uncorrected visual or uncorrected hearing impairment.
19. Allergy to strawberry.
20. Positive pregnancy test
21. Subject is judged by the Investigator or Medical Monitor to be inappropriate for the study
A Master Protocol Study of Orforglipron (LY3502970) in Participants With Hypertension and Obesity or Overweight (ATTAIN-Hypertension) GZL2

GZL2 is an independent study conducted under the GZPL master protocol. GZL2 study will evaluate the efficacy and safety of orforglipron for treatment of hypertension in participants with obesity or overweight.


Eligibility Criteria:
Inclusion Criteria:

* refer to the GZPL master protocol study for screening eligibility.

Exclusion Criteria:

* refer to the GZPL master protocol study for screening eligibility.
A Dose Ranging Study To Investigate The Efficacy And Safety Of SB-742457 In Alzheimer's Disease

The purpose of this study is to find out if SB-742457 is a safe treatment and what effects it has on the symptoms of mild to moderate Alzheimer's disease. SB-742457 is a new treatment which is thought to increase the levels of certain chemicals in the brain that are often decreased in patients with Alzheimer's disease.


Eligibility Criteria:
Inclusion criteria:

* Clinical diagnosis of probable mild-to-moderate Alzheimer's disease as determined by the NINCDS-ADRDA and DSM-IV criteria with an MMSE score of 12-24.
* Subjects and their caregivers must provide informed consent prior to study entry.
* Adequate blood pressure and laboratory values.

Exclusion criteria:

* Females of child-bearing potential.
* Have other causes of dementia such as vascular damage, depression, bipolar affective disorder, schizophrenia, syphilis, vitamin B12 deficiency or thyroid deficiency.
* Subjects taking medication for Alzheimer's disease or centrally acting agents which might impact study outcomes.
* Subjects taking agents for which there is a theoretical risk of interaction with SB-742457.
* Subjects with known hypersensitivity to sunlight or seizures.
Usefulness of Early Warning Systems in Detecting Early Clinical Deterioration After Intensive Care Discharge

The VitalPac Early Warning Score (VIEWS) scoring system, developed by Prytherch et al., Is an early warning system that aims to predict the first 24-hour mortality in emergency patients.

National early warning score (NEWS) is another early warning scoring system recommended by the Royal College of Physicians in London to detect early clinical deterioration in hospitalized patients.

The aim of this study was to determine the early clinical deterioration after ICU and hence the rate of admission to intensive care and to evaluate whether these two scoring systems can be used to determine early clinical deterioration in intensive care early discharge.


Eligibility Criteria:
Inclusion Criteria:

* over 18 years,
* discharged from the ICU and returned within 24 hours

Exclusion Criteria:

* under 18 years old, postoperative patients, pregnant women
The Muscle Relaxation-study

The purpose of this investigation is to compare the surgical conditions during laparoscopic cholecystectomy at a low intra-abdominal pressure with deep or moderate muscle relaxation.

The primary hypothesis is that surgical conditions during laparoscopic cholecystectomy are better with deep muscle relaxation than moderate muscle relaxation.

The purpose of this investigation is to compare the surgical conditions with two degrees of neuromuscular blockade in patients who have laparoscopic cholecystectomy done with pneumoperitoneum 8 mmHg.

Eligibility Criteria:
Inclusion Criteria:

* Patients older than 18 years
* Scheduled for elective laparoscopic cholecystectomy
* Can read and understand danish
* Women must be post-menopausal, sterilized or use safe contraception in the form of a coil or oral anti-contraceptives

Exclusion Criteria:

* Known allergy to medications that are included in the project
* Presence of severe renal disease, neuromuscular disease, reduced liver function
* Nursing or pregnant
* Indication for crash induction
* For fertile women: Missing negative pregnancy-test
Concepts for Analgosedation During Placement of Regional Anaesthesia Before Operations.

Aim of the study is to specify the best analgosedation technique during placement of regional anaesthesia from the patients' view.

In this double blind randomized trial the investigators will be testing the application of drugs administered intravenously (fentanyl-bolus, remifentanil-infusion, clonidine-bolus) or transcutaneously (EMLA salve) or placebo (NaCl 0,9% i.v. and skin protection salve).

In this doubleblind randomized pilot trial, patients will receive one of five possible combinations to assess which medication leads to the best medication during placement of regional anaesthesia. This assessement includes NRS, patients' satisfaction and wellbeing. The tested substances will be administered intravenously (fentanyl-bolus, remifentanil-infusion, clonidine-bolus) or transcutaneously (EMLA salve). The fifth combination will be the control group with only placebo medication. We expected to get first information for objectifying analgosedation during placement of regional anaesthesia for the conduction of further studies in this field.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients planed electively for orthopedic surgery

Exclusion Criteria:

* Missing patient's consent
* Intolerance against study medication
Observational Study on the Long Term Safety of Kuvan® Treatment in Patients With Hyperphenylalaninemia (HPA) Due to Phenylketonuria (PKU) or BH4 Deficiency

Kuvan® is a synthetic copy of a body's own substance called tetrahydrobiopterin (BH4). BH4 is required by the body to use an amino acid called phenylalanine in order to build another substance called tyrosine.

Kuvan® received marketed authorisation in Europe in December 2008 and is now available in several European countries for the treatment of Hyperphenylalaninemia (HPA).

The primary objective is to assess the long-term safety in subjects treated with Kuvan®.

Secondary objectives are to provide additional information regarding:

* Safety in specific subject groups (elderly, pediatric, pregnant women and subjects with renal or hepatic insufficiency).
* Growth and neurocognitive outcomes for subjects with hyperphenylalaninemia (HPA) who are receiving treatment with Kuvan®.
* Progress and outcome of pregnancy for women with HPA who become pregnant while receiving treatment with Kuvan® (these women will be enrolled in a dedicated sub-registry).
* Assessment of adherence to diet and to Kuvan®.
* Assessment of long-term sensitivity to Kuvan®treatment.

This is an observational, multicenter, drug registry Study. The study will have a total duration of 15 years, including a 10-year inclusion period. No diagnostic, therapeutic or experimental intervention is involved. Subjects will receive clinical assessments, medications and treatments solely as determined by their study physician.

Eligibility Criteria:
Inclusion Criteria:

* Adult or pediatric subject (no age limit) of either gender with HPA due to PKU or BH4 deficiency.
* Have been shown to be responsive to BH4 or Kuvan. (Note: For Spain only-Have been shown to be responsive to BH4 or for the newly diagnosed subjects to be responsive to Kuvan as defined in the Summary of Product Characteristics \[SmPC\]).
* Currently being treated with Kuvan® at a participating centre.
* Subject or parent/legal guardian willing and able to provide written signed informed consent and given before any data collection. If a child is old enough to read and write, a separate assent form will be given.

Exclusion Criteria:

* Known hypersensitivity to Kuvan®
* Legal incapacity or limited legal capacity without legal guardian representation
* Breast-feeding
Effects of Characters on Parents' Perceptions of Breakfast Cereals

Purpose: To test how the presence of characters on breakfast cereals affects parents' perceptions and purchase intentions for their children.

Participants: \~1,000 parents of children ages 2-12 Procedures: After completing a screener and reviewing a consent form, participants will complete two unrelated experimental studies. Participants will then move on to this study, where they will be randomized into conditions and view three breakfast cereal box images, with or without characters. They will then be asked a series of questions about their children and their perceptions about the breakfast cereals

The use of characters, such as cartoons, is a prolific form of child-oriented marketing and may have particularly persuasive power in children. Parents and caregivers - who make most food purchases for children - are also persuaded by child-oriented marketing practices. The purpose of this study is to examine the impact of characters on parents' perceptions and purchase intentions of a breakfast cereal product.

Setting: This is an online study using Qualtrics. Recruitment: Participants will be recruited by Qualtrics panel company, a survey research firm through which participants are recruited voluntarily.

Informed Consent: Participants will read a written consent document that includes information about the study's purpose, expectations, and possible risks and benefits. Participants will acknowledge that they have read and agreed to the terms by clicking forward.

Randomization: Participants will be randomly assigned to one of two groups: 1.) control (breakfast cereal boxes with no characters) or 2.) characters (breakfast cereal boxes with a brand and at least one licensed character). Participants will view three brands (Frosted Flakes, Apple Jacks, Froot Loops).

Assessment: Using an online platform (Qualtrics), participants will complete an eligibility screener prior to the first experiment. They will then complete two unrelated experimental studies before beginning the current study. Participants will then be randomized into a condition and shown an image of the three cereal brands in random order. After each brand exposure, participants will be asked to respond to a series of questions measuring the following constructs: purchase intentions, perceived healthfulness, and perceived child appeal. After viewing all three brands and answering the aforementioned questions, participants will be queried on their perceptions of their child's perceived food-fussiness. Demographic information, such as age, gender, race/ethnicity, education, and income will be gathered at the end of the study.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 or older
* Parent or guardian of at least one child between the ages of 2-12

Exclusion Criteria:

* \<18 years old
* is not the parent or guardian of a child between the ages of 2-12
A Multicenter，Double-Blind and Randomized Controlled Trial of Fengshigutong Capsule in the Treatment of Ankylosing Spondylitis

This is a randomized, double-blind, multicentral clinical trial to investigate the efficacy and safety of Fengshigutong Capsule in the treatment of active ankylosing spondylitis(AS). The primary purpose is to assess the different maintaining treatment programme in AS patients with controlled inflammation by Imrecoxib. The trial will include 180 patients who will be divided into three group: Fengshigutong Capsule plus Imrecoxib group, Imrecoxib group and Fengshigutong Capsule group. Patients will complete the 4-week therapy.


Eligibility Criteria:
Inclusion Criteria:

* 18 to 65 years
* Meet 1984 modified New York criteria for AS
* The Bath AS Disease Activity Index (BASDAI) ≥4 on a 0-10-cm visual analog scale or the Ankylosing Spondylitis Disease Activity Score using the C-reactive protein level (ASDAS-CRP) ≥1.3
* NSAIDs washout period of at least 7 days prior to randomization
* DMARDs washout period of at least 4 weeks prior to randomization
* Corticosteroids washout period of at least 2 weeks prior to randomization
* Biological agents washout period of at least 3 months prior to randomization.

Exclusion Criteria:

* Peptic ulcer
* Unstable cardiac diseases
* Hematologic disorders
* Psychosis
* Malignancy
* Multiple sclerosis
* severe COPD
* fibromyalgia and other rheumatic disease
* Corticosteroids were injected into the articular cavity within 3 months
* Chinese medicine was taken within 28 days
* Pregnant and lactating women
* Alcohol and drug abuse
* Spinal cord compression
Nerve Coaptation in DIEP Flap Breast Reconstruction

The sensory recovery of the breast remains an undervalued aspect of breast reconstruction and surgical reinnervation is not regarded as a priority by most reconstructive surgeons. A prospective study was conducted of all patients who underwent either innervated or non-innervated DIEP flap breast reconstruction in Maastricht University Medical Center and returned for follow-up between September 2015 and July 2017. Semmes-Weinstein monofilaments were used for sensory testing of the breast. This study showed that nerve coaptation in DIEP flap breast reconstruction resulted in a significantly improved sensation of the reconstructed breast compared to non-innervated flaps.


Eligibility Criteria:
Inclusion Criteria:

* Female patients 18 years or older
* Unilateral or bilateral DIEP flap breast reconstruction
* Returned for follow-up between September 2015 and July 2017
* Informed consent

Exclusion Criteria:

* Bilateral breast reconstruction with a unilateral innervated DIEP flap and a contralateral non-innervated flap
* Flaps that required a take-back
Educational Intervention to Improve HPV Vaccination Decision Quality

The purpose of this study is to evaluate an innovative approach to improving HPV vaccination among the Hispanic population. The objectives/aims of this HPV educational intervention project are:

1. To measure the quality of the HPV vaccine decision among participants in different arms of the intervention
2. To determine patterns of intervention utilization among participants in different arms of the intervention, and

The implementation of this educational intervention in clinic waiting rooms is intended to assist primary care providers in communicating HPV vaccine awareness and education to parents and patients in a culturally tailored format.

While HPV infection is nearly ubiquitous among the sexually active population, the morbidity and mortality from HPV-related diseases disproportionately affects minorities and the poor. Hispanic women are at particularly high risk as they have the highest rates of invasive cervical cancer when compared to all other racial or ethnic groups in the U.S. Initiating the 3-dose HPV vaccination series is more common among Hispanic adolescents than whites, but series completion has been lowest among Hispanic populations.

To understand barriers to HPV vaccination and to provide insight into ways in which an existing educational intervention should be modified for a Hispanic population, the investigators conducted focus groups among Hispanic parents and Latina young adults. All groups reported vaccine cost, access to insurance, and a general lack of awareness and/or understanding of either HPV or the vaccine as barriers. All groups also wanted substantially more "general" information about both HPV and the vaccine in order to make informed vaccination decisions. The educational intervention was generally well received but there were universal suggestions from all the groups to provide additional basic information about HPV infection, to add information about the vaccine for boys/young men, and to modify the color scheme and logo to make it more eye-catching and pleasing.

This current phase of the project will be comprised of real world testing of an iPad-based educational intervention about HPV, "Combatting HPV Infection and Cancer" (CHICOS) that has been revised and developed per focus group feedback to target the Hispanic population.

By providing information that patients and parents have clearly indicated they want in a way that is culturally sensitive and meaningful and also individually personalized, the investigators hope to improve the HPV vaccination decision-making process.

Eligibility Criteria:
Inclusion Criteria:

1. Parents of an adolescent between the ages of 9-17
2. A young adult patient between the ages of 18-26
3. Adolescent/young adult who has not yet received all three doses of the HPV vaccine.
4. Parent/young adult who can read and converse in either English or Spanish

Exclusion Criteria:

1. Age \<18,
2. Prisoners
3. Decisionally challenged subjects
4. Those who cannot read and converse in either English or Spanish
5. Those who have received all 3 doses of the HPV vaccine