cyrilzakka/clinical-trials huggingface dataset:
Study to Evaluate 13 C Isotope Ratio Measurement for Urea Cycle Capacity Assessment

In this short-term study a method for the evaluation of the metabolic competency of the urea cycle in vivo will be assessed. In order to monitor the efficacy of new treatment options for patients with urea cycle disorders and to monitor the severity of the disease, a reliable and safe quantitative method for the measurement of the urea cycle flux is required.

Urea synthesis will be evaluated by administering sodium \[1-13C\]-acetate and measuring subsequent incorporation of \[13C\] label from Na-acetate into urea in healthy volunteers and asymptomatic subjects genetically disposed to urea cycle disorders.


Eligibility Criteria:
Inclusion Criteria:

* Group 1 + 2: Healthy subjects
* Group 3: Healthy asymptomatic subjects genetically disposed to urea cycle disorders
* All: age 18 to 50 years (adult)
* Written informed consent

Exclusion Criteria:

* Presence of acute infection
* Participation in other clinical trials within 30 days prior to inclusion
* Severe coagulopathy
* Severe systemic or chronic disease
* Pregnancy or lactation
Pre-operative Carbohydrates in Diabetic Patients Undergoing CABG

Preoperative carbohydrates (CHO) supplement has been shown to alleviate postoperative insulin resistance (IR) in nondiabetic patients undergoing a variety of surgeries. However, it remains controversial whether preoperative CHO could yield similar effects in diabetic patients. Thus, the investigators design a randomized controlled trial investigating the impact of preoperative CHO on postoperative IR and clinical outcomes in diabetic patients undergoing cardiac surgery. The results of the study may give some clinical implications and further improve perioperative care for diabetic patients.

CHO supplement has been widely investigated in nondiabetic patients undergoing various surgeries. It has been proved that preoperative CHO could alleviate postoperative insulin resistance (IR) and improve patients' well-being in nondiabetic patients. However, whether preoperative CHO could yield similar effects in diabetic patients remains controversial. Till now, seldom has the administration of preoperative CHO been investigated in diabetic patients and few studies reported IR and postoperative recovery of diabetic patients undergoing cardiac surgery. The investigators present a prospective, single-center, single-blind, randomized, no-treatment controlled trial of preoperative CHO on diabetic patients undergoing off-pump coronary artery bypass grafting (OPCAB). A total of 62 patients will be enrolled and randomized to either Group CHO or Group control (CTRL). Patients in group CHO will receive CHO fluid containing 50 g of carbohydrates the evening before surgery (20:00-24:00) while their counterparts in Group CTRL will be fasted after 20:00 the evening before surgery. The primary endpoints are postoperative insulin resistance (IR) assessed via homeostasis model assessment (HOMA). The secondary endpoints are the potential mediators relating to IR including inflammatory factors and stress reactions assessed by serum cortisol. Exploratory endpoints are in-hospital clinical endpoints.

Eligibility Criteria:
Inclusion Criteria:

1. Previously diagnosed T2DM
2. Diagnosed with CAD with coronary angiography and indicated for OPCAB
3. Age between 18 and 75 years old
4. First operation in the morning and anesthesia induced around 8:00
5. Written informed consent by the patients

Exclusion Criteria:

1. Combined with other heart diseases or vascular malformations that require surgery in addition to OPCAB
2. Presence of symptoms or signs of heart failure such as orthopnea, distended jugular vein, lower extremity edema, etc.
3. Reduced LVEF (lower than 50%)
4. Combined with gastroesophageal reflux
5. Combined with thyroid insufficiency requiring replacement therapy with levothyroxine
6. Combined with adrenal insufficiency requiring replacement therapy with corticosteroids
7. Refuse to participate.
The Psychological Effect of the Covid-19 Pandemic

At the end of 2019, the novel coronavirus disease (Covid-19), which emerged in China, has become a public health emergency of international concern. Disease outbreaks both affect the physical and psychological health of individuals. The aim of this study was to investigate the levels of stress, anxiety, depression, and Covid-19 fear in health sciences intern students during the Covid-19 pandemic.


Eligibility Criteria:
Inclusion Criteria for students:

* be over 18 years old
* have taken the professional practice/internship lecture
* be practicing in the hospital
* not have any disease

Inclusion Criteria for control:

* over the age of 18
* without any disease
* who routinely work during the pandemic

Exclusion Criteria:

* body mass index (BMI) \<17 kg/m2
* any chronic illness, psychological disorder, and perception problem
* be dental operation or significant damage to the teeth or oral mucosa
I-125 Versus Pd-103 for Medium Risk Prostate Cancer

hypothesis: the shorter half-life of Pd-103 versus I-125, will increase the rate of tumor eradication.

A total of 660 patients with AJC clinical stage T1c-T2a prostatic carcinoma (Gleason grade 7 to 9 and/or PSA 10-20 ng/ml) will be randomized to implantation with I-125 (144 Gy) versus Pd-103 (124 Gy).

Objective: The objective of this study is test the hypothesis that the shorter half-life of Pd-103 versus I-125, will increase the rate of tumor eradication.

Research plan:

A total of 660 patients with AJC clinical stage T1c-T2a prostatic carcinoma (Gleason grade 7 to 9 and/or PSA 10-20 ng/ml) will be randomized to implantation with I-125 (144 Gy) versus Pd-103 (124 Gy).

Methodology:

Randomization will be accomplished by the method of random permuted blocks.

Cancer status will be monitored by yearly serial serum PSA. Treatment-related morbidity will be monitored by personal interview, using standard American Urologic Association and Radiation Therapy Oncology Group criteria at 1, 3, 6, 12 and 24 months.

Primary endpoint: Time to treatment failure. Patients with serum PSA above 0.5 ng/ml two years or more after treatment will be considered to have residual or recurrent cancer and to have failed therapy.

Eligibility Criteria:
Inclusion Criteria:

* PSA 4-10 ng/ml
* Gleason score 5 or 6
The Effect of Printing Layer Thickness on the Accuracy of Computer Aided Surgical Guides

The purpose of this study is to evaluate the effect of printing layer thickness on accuracy of computer aided surgical guide

Computer aided surgical guide has many variables that affect its accuracy , in this study one variable is considered that may affect the accuracy of surgical guide which is printing of layer thickness of surgical guide whether 50 micron or 100 micron.

computer aided surgical guide is constructed by imaging the patient pre-operative cone beam CT wearing scan appliance , then virtual implant placement on special soft ware ( Blue sky Bio ) and optical scanning of patient casts , afterword superimposition of the virtual implants on the scanned casts to design the surgical guide and printing on 3D printer ( Zenith 3D printer , Dentis , Korea ) with printing layer thickness 50 micron in first group and 100 micron in second group . Fixation of surgical guide in patient mouth and drilling of implant osteotomy through the guiding sleeves , post-operative Cone Beam CT with the same apparatus and setting as pre-operative scan .

Finally, the pre-operative and post operative scans were then overlapped to measure linear and angular deviation of the virtually planned and actual implants position.

Eligibility Criteria:
Inclusion Criteria:

* patients partially or totally edentulous arches .
* patients with Bucco-lingual bone thickness \>6 mm allowing flapless implant placement
* patients free from any systemic diseases that may affect bone quality e.g diabetes .

Exclusion Criteria:

* patients with thin ridges.
* patients with systemic disease that may affect bone quality.
* Patients with poor oral hygiene and active periodontal diseases.
* Anatomical situations requiring regenerative procedure.
Effect of Tranexamic Acid on Postoperative Bleeding Following Sinus and Nasal Surgery

The purpose of the research is to assess the effectiveness of a dose of intravenous tranexamic acid (TXA) given intraoperatively to reduce postoperative bleeding after endoscopic sinus or nasal surgery (e.g. septoplasty, endoscopic sinus surgery, turbinate surgery). This medication has been shown to decrease blood loss during this type of surgery, but the implications for bleeding following surgery are unclear. Any impact on postoperative bleeding will be assessed over the first 7 days following surgery leading up to the first scheduled postoperative clinic visit. Patients will keep a standardized daily diary of their bleeding experience by indicating on a 0-10 visual analog scale (VAS) their impression of their bleeding.

The primary outcome is the patient-reported visual analog scale (VAS) bleeding score on each day after surgery. The secondary outcomes include the the frequency with which the otolaryngology resident service is requested to evaluate patients in the recovery unit for postoperative bleeding concerns and the frequency of interventions such as application of hemostatic materials, packing, cautery, and/or return to the operating room.


Eligibility Criteria:
Inclusion Criteria:

* Scheduled to undergo elective sinus or nasal surgery (e.g. septoplasty, inferior turbinate reduction, endoscopic sinus surgery)
* Age 18 or greater
* English-speaking
* Able to provide consent

Exclusion Criteria:

* Minors (age\<18)
* Pregnant or may become pregnant by time of surgery
* Prisoners
* Non-English speaking
* Foreign citizens
* Unable to provide consent
* Known pro-thrombotic coagulation disorders
* Active intranasal drug use (e.g. cocaine)
* Surgery is for a sinonasal tumor or other sinus pathology not described in inclusion criteria
* Enrollment is in conflict with existing study participation
Effect of Infant Formula Intake on Infant Growth From 0 to 6 Months.

From birth to 5 months, milk is the essential and unique food of the newborn. The French National Nutrition Program (PNNS) recommends exclusive breastfeeding "up to 6 months and at least 4 months for a healthy benefit". However, only 36% of infants 0-6 months of age are exclusively breastfed worldwide. Some mothers choose to give infant formula to their baby in the first few months of life. This decision may be a personal choice or be imposed by pathophysiological situations.

The nutritional requirements of the infant are specific, which implies adequate nutrition. Infant formulas and follow-up formulas are therefore complex products, specially developed for a group of vulnerable consumers. In fact, the compositional and information requirements for infant formula are highly regulated.

Even clinical studies are not required to market an infant formula, it is important to obtain objective date on infant growth. Therefore, this study proposes to evaluate the effect of the consumption of an infant formula on the growth of infants from 0 to 6 months in comparison with the growth curves of the World Health Organization (WHO).


Eligibility Criteria:
Inclusion Criteria:

* 0 to 3 weeks
* Infants whose mothers do not wish or can not breastfeed for personal or medical reasons
* Child followed by a general practitioner or pediatrician
* Informed consent form signed by the legal representatives of the subject
* Commitment of legal representatives to follow the constraints generated by the study
* Insured

Exclusion Criteria:

* Nursing mother
* Infant born prematurely before 37 weeks of amenorrhea
* Child allergic to cow's milk proteins
* Pathological pregnancy (hypertension, infection, gestational diabetes, etc.);
* Chronic or acute illness (metabolic or neuromuscular diseases, epilepsy, asthma, diabetes, digestive, renal, cardiac or haematological diseases);
* Incapacity for the legal representative(s) to understand or adhere to the protocol
* Mother smoking or vapoting during pregnancy;
* Subject involved in another clinical study or in an exclusion period from another study
* Legal representatives deprived of liberty
* Legal representatives in a position to judicial protection
* Weight of the subject according to age and sex, not included between the 3rd and the 97th percentile of the WHO Child Growth Standards
* Subject height according to age and sex, not between the 3rd and the 97th percentile of the WHO Child Growth Standards
* BMI of the subject according to age and sex, not included between the 3rd and the 97th percentile of the WHO Child Growth Standards
* Head circumference of the subject according to age and sex, not included between the 3rd and the 97th percentile of the WHO Child Growth Standards
European Trial Into Mpox Infection

The goal of this randomized controlled double-blind clinical trial is to test the drug tecovirimat in patients with mpox (previously known as monkeypox) disease.

The main questions it aims to answer are:

* Is tecovirimat effective in treating mpox infection.
* Is tecovirimat safe to treat patients with mpox infection.

Participants will receive either the drug tecovirimat orally, 600 mg twice per day, or a matching placebo. The outcome of the infection and the side effect experienced will be compared between the two groups.


Eligibility Criteria:
Inclusion Criteria:

* Polymerase Chain Reaction (PCR) /Nucleic Acid Amplification Test (NAAT) -confirmed mpox infection
* The presence of active skin or mucosal lesion(s)
* Signed Informed Consent Form

Exclusion Criteria:

* Age \<18 years.
* Body weight \<40 kg
* Pregnant and breastfeeding patients are not eligible for inclusion in this study.
* Lack of mental capacity to provide informed consent
* Trial participation is considered not in the best interest of patient
* Known hypersensitivity to the active substance or to any of the excipients of the study drug.
* Use of contraindicated treatment repaglinide. (Repaglinide, an oral treatment for diabetes mellitus, may be discontinued while taking study treatment with the agreement of the patient's general practitioner, who may start alternate diabetes treatment if considered necessary.)
* Previous, current or planned use of another investigational drug (tecovirimat) at any point during study participation.
* The patient's own doctor considers there to be a definite indication for the patient to receive tecovirimat or the local guidelines establish that tecovirimat treatment should be initiated
* The patient's own doctor considers there to be a definite contraindication to the patient receiving tecovirimat.
* The patient suffers from hereditary problems of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption.
Naloxone and Intravenous Methylnaltrexone Effects on Bladder Function

This is a double-blind, randomized, study at a single clinical site investigating the effect of methylnaltrexone and naloxone versus placebo in healthy males who have received a short-acting opioid, remifentanil.


Eligibility Criteria:
Inclusion Criteria:

1. Healthy males, 18 to 65 yrs with normal urinary function
2. Body weight less than 150 kg and Body Mass Index between 20-32.

Exclusion Criteria:

1. Females
2. History of drug or alcohol abuse
3. History of significant chronic illness (cardiovascular, gastrointestinal, pulmonary, neurologic, endocrine, renal, hepatic, etc.)
4. Subjects who received opioids for one week or longer in the last 2 months.
Work Organization and Cardiovascular Disease

To determine the combined effects of job strain and social isolation on cardiovascular morbidity and mortality.

BACKGROUND:

Much of the medical and epidemiological research on the causes of cardiovascular disease has concentrated either on individual life style behaviors such as smoking and exercise or on biomedical risk factors such as hypertension, and diabetes. This research has provided the basis for improvements in personal health behaviors and in the treatment of hypertension which has reduced the incidence of cardiovascular disease in this country. However, even the best statistical models, incorporating all such risk factors, leave a significant proportion of cardiovascular disease mortality and morbidity unexplained. Major differences in cardiovascular disease rates have also been observed between different social classes and different societies. These findings have led epidemiologists and sociomedical researchers to investigate other types of variables, including psychosocial factors, such as personal predispositions, social support networks, and work-related stress. A series of studies, in a variety of disciplines, suggested that occupational stress may contribute to the development of cardiovascular disease.

A major source of data was the Swedish Survey of Living Conditions (ULF). The ULF was drawn from a sample which included the total occupational and demographic variation of an entire society. The survey contained information on age, sex, marital status, occupational class background and nationality of respondents and parents, residence, education, past employment history and income data.

DESIGN NARRATIVE:

In this non-concurrent prospective study, ten years of follow-up data were linked with five years of data from the Survey of Living Conditions collected between 1976 and 1980. Total and cause-specific mortality data were obtained from the Swedish National Death Registry and morbidity incidence data from the Registry of Hospitalizations. The relationship between the duration of exposure time and disease risk was examined utilizing occupational history information which was combined with Theorell's Occupational Psychosocial Scoring System. Logistic regression analysis was used to examine the relative risks associated with adverse work characteristics and to test for potential interactions and confounding effects. Cox's proportional hazards model was used as an approximation of life table methods. Analysis was performed separately for men and women.

The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.

Eligibility Criteria:
No eligibility criteria
A Safety Study of SGN-CD19A for Leukemia and Lymphoma

This is a phase 1, open-label, dose-escalation, multicenter study to evaluate the safety and tolerability of SGN-CD19A in adult and pediatric patients with relapsed or refractory B-lineage acute lymphoblastic leukemia (B-ALL), Burkitt lymphoma or leukemia, or B-lineage lymphoblastic lymphoma (B-LBL).


Eligibility Criteria:
Inclusion Criteria:

* Adult patients must be relapsed or refractory to at least 1 prior multi-agent systemic therapy. Pediatric patients must be relapsed or refractory to at least 2 prior multi-agent systemic therapies. Patients with acute lymphoblastic leukemia who are Philadelphia chromosome-positive must have failed a second generation tyrosine kinase inhibitor.
* Eastern Cooperative Oncology Group status of 2 or lower
* Pathologically confirmed diagnosis of B-lineage acute lymphoblastic leukemia, Burkitt leukemia or lymphoma, or B-lineage lymphoblastic lymphoma
* Measurable disease

Exclusion Criteria:

* Allogeneic stem cell transplant within 60 days, active acute or chronic graft-versus-host disease (GvHD), or receiving immunosuppressive therapy as treatment for GvHD
People Living With HIV, Oral and Oropharyngeal Cancer, and Health Equity

This is an exploratory qualitative study among People Living With HIV (PLWH) of diverse racial/ethnic and sexual and gender minority (SGM) identities to explore individual, interpersonal, and structural oral health equity factors that serve as barriers or facilitators of accessing oral health care, knowledge and perceptions of human papillomavirus (HPV) vaccination and Oral squamous cell carcinoma (OSCC) /Oropharyngeal squamous cell carcinoma (OPSCC), and to collect recommendations on how to increase access to oral health care and engage PLWH in OSCC/OPSCC prevention.

OBJECTIVES:

1. To identify individual, interpersonal, and structural oral health equity factors (e.g., internalized stigma; enacted stigma; transportation/hours) that serve as barriers or facilitators to accessing regular and appropriate oral health care, among PLWH of intersecting racial/ethnic and SGM groups.
2. To explore knowledge and perceptions about causes, risk factors, prevention, and screening for OSCC/OPSCC and HPV vaccination and if identity group membership influences knowledge and perceptions of these issues.
3. To elicit recommendations for improving access to regular and appropriate oral health care, and suggestions on how to engage PLWH from diverse identity groups in prevention interventions.

OUTLINE:

There will be one screening and enrollment phone call and only one study visit for the Focus Group Discussions (FDGs). A short quantitative survey will be administered.

Eligibility Criteria:
Inclusion Criteria:

* Participants must be 18-years old or older.
* Participants must be individuals living with HIV
* Ability to speak and understand English
* Identify as one or more racial/ethnic minority groups or sexual and gender minority groups
* All genders and members of all races and ethnic groups are eligible for this study.

Exclusion Criteria:

* Younger than 18-years old.
* Not living with HIV.
* Not able to speak and understand English.
* Not classified as one or more racial/ethnic minority groups or sexual and gender minority groups.
Serratus Anterior Block and Catheter Use in Rib Fractures in the Emergency Department

The main aim of this study is to determine whether Serratus Anterior Plane (SAP) blockade provides improved pain relief after rib fractures compared to epidural administration of local anaesthetic. The investigators aim to show that SAP catheters (SAPC) can be placed in more situations and are less operator-dependent then thoracic epidural anaesthesia (TEA). This reduces the waiting time required to achieve satisfactory analgesia in the patient. Optimal analgesia allows early respiratory physiotherapy and reduction in the complications of multiple rib fractures.

Pain from rib fractures is severe. The sensory nerves of the thoracic wall lie in the SAP and a single ultrasound-guided injection of local anaesthetic spreads widely and provides useful post-injury analgesia for several hours. If a catheter is left in the SAP, the nerve blockade can be maintained for several days.

Rib Fracture pain is traditionally treated with oral/ intravenous analgesics or TEA. Opiate analgesia via patient controlled analgesia (PCA) can work very well but it is associated with excessive sedation, constipation, nausea and vomiting. Continuous TEA is generally regarded as the gold standard but it demands monitoring by adequately trained ward staff and is commonly associated with high failure rates and increased risk of complications. SAPC has also been used when TEA and PCA were not desirable.

The primary outcome will be the amount of morphine analgesia required by the patient. Secondary outcomes will be pain scores (at rest and on movement), the side effects of morphine, complications of TEA/ SAPC, respiratory function changes and a quality of recovery assessment.

The control group will have an epidural block and catheter placed. The treatment group will have SAP blocks and catheters placed under ultrasound guidance. Both blocks will be tested to ensure good pain relief. To avoid potential confounding effects, oral painkillers will adhere strictly to the study protocol.


Eligibility Criteria:
Inclusion Criteria:

* Patients aged over 18 years suffering 2 or more rib fractures

Exclusion Criteria:

1. Significant renal dysfunction (baseline creatinine \>150μmol/l - morphine contra- indicated)
2. Pregnancy
3. Patients with chronic pain on regular analgesic medication
4. Patients with significant coagulation abnormality (unsafe to site blocks)
5. Participation in another interventional study that will interact with this trial.
6. Patients unable to give informed consent
7. Hypersensitivity to local anaesthetic (or any other study drug).
8. Contraindication to NSAID (peptic ulceration or sensitive asthma)
9. Weight \<50kg