cyrilzakka/clinical-trials huggingface dataset:
Whole Genome Single Nucleotide Polymorphisms in Elderly Patients With Postoperative Cognitive Dysfunction

Postoperative cognitive dysfunction (POCD) presents as a long-lasting decline in cognitive function following surgery. Recognized as an important neuropsychological complication of anesthesia and surgery, POCD occurs predominantly in elderly patients, and even after minor procedures. It affects 41% of patients over the age of 60 years one week after major noncardiac surgery, and persists until the third postoperative month in 13% of cases. POCD has an adverse impact on quality of life, may result in prolonged hospitalization and increased health care costs, and is associated with the risk of leaving the labor market prematurely and dependency on social transfer payments, as well as increased one-year mortality. Elderly patients are particularly at risk. Other risk factors include a pre-existing cognitive impairment, cerebral, cardiac or vascular disease, diabetes, alcohol consumption and a lower level of education. The occurrence of postoperative delirium seems to predispose patients to POCD. However, POCD itself is not associated with the development of dementia.

The pathogenic mechanism leading to POCD remains unclear. Numerous etiologic pathways have been suggested: cerebral ischemia due to impaired intraoperative cerebral perfusion and/or oxygenation, systemic inflammation and the effect of proinflammatory cytokines on the brain, altered cholinergic neurotransmission, anesthetic neurotoxicity, hormonal changes induced by surgical stress, sleep or circadian disturbances, or genetic factors.

Several studies have explored possible associations between a specific genotype and POCD; however, these were predominantly performed in patients undergoing cardiac surgery or carotid endarterectomy. Previous reports primarily focused on the analysis of the apolipoprotein E genotype as a predisposing factor for POCD. Results of some of these studies have been pooled in a recent meta-analysis. Other studies have investigated polymorphisms of the human circadian clock gene HPER3, complement, cytochrome P450, platelet glycoprotein IIIa, phosphodiesterase 4D, P-selectin, C-reactive protein, and the inducible nitric oxide synthase promoter.

The primary aim of this retrospective study of available cohort data is to investigate a specific genotype and to identify single nucleotide polymorphisms (SNPs) which may predispose elderly patients undergoing major noncardiac surgery to POCD.


Eligibility Criteria:
Inclusion Criteria:

* American Society of Anesthesiologists (ASA) physical status I-IV
* Major noncardiac surgery under general anesthesia
* Native German or French speakers

Exclusion Criteria:

* Cardiac surgery
* Neurosurgery
* Surgery within 12 months prior to inclusion
* History of intracranial or cerebrovascular pathology
* Preoperative Mini-Mental State Examination (MMSE) score \<24
* Psychiatric disease and long-term psychopharmacological treatment
Geriatric Assessment for Older Kidney Transplantation Candidates

Geriatric assessment is now widely used to decide whether older patients with chronic kidney disease should be put on the kidney transplantation waiting list. This study aims to evaluate the association between Geriatric assessment and inscription on kidney transplantation.

There is a high proportion of older patients among patients with kidney failure, raising the question of the access to kidney transplantation within these patients. Geriatric assessment is now widely used to decide whether older patients with chronic kidney disease should be put on the kidney transplantation waiting list.

This study aims to evaluate the association between Geriatric assessment and inscription on kidney transplantation. Secondary objectives includes the analysis of the association between Geriatric assessment and:

* post-kidney transplantation outcomes
* quality of life.

It also includes the evolution of Geriatric assessment while still on waiting list and after kidney transplantation.

This study takes place in an University Hospital in Caen, France. This hospital is the only one performing kidney transplantation in the three French departments around. Candidates for kidney transplantation older than 70 years are systematically evaluated by a trained nurse and a geriatrician to perform a comprehensive geriatric assessment, evaluating cognitive functions, risk of fall, nutrition, frailty, functional status, and depressive symptoms. These patients are followed-up each year while still on the waiting list, and once after kidney transplantation. All patients evaluated within this consultation are proposed to enter the study. Patients are excluded in case of refusal or if they are unable to provide informed consent. The inclusion began in January 2019.

Eligibility Criteria:
Inclusion Criteria:

* All patients addressed for Geriatric assessment before inscription on kidney transplantation waiting list in Caen University Hospital, France

Exclusion Criteria:

* Patient refusal
* Patient unable to provide informed consent
An Ovarian, Primary Peritoneal or Fallopian Tube Cancer Study for Patients That Have Not Received Prior Chemotherapy

This is a phase III randomized study comparing induction treatments of Gemcitabine and Carboplatin versus Paclitaxel and Carboplatin, with or without consolidation therapy for patients that do not have any evidence of disease after completion of six cycles of induction therapy. Patients with disease after induction therapy will crossover to receive single agent therapy.

This study (Study B9E-US-S302) is a multicenter, comparative, open-label randomized, superiority, trial evaluating Gemcitabine and Carboplatin to the standard of care. Both treatment arms will be given the option to receive elective consolidation therapy of Paclitaxel 135 mg/m\^2 given every 28 days for one year. Patients not achieving a complete response will crossover to the opposite single agent.

Eligibility Criteria:
Key Inclusion Criteria:

* Patients with a histologic diagnosis of primary peritoneal carcinoma, epithelial ovarian carcinoma or fallopian tube carcinoma Stage IC, II, III or IV.
* All patients must have had surgery for fallopian, ovarian or peritoneal carcinoma to establish the diagnosis and have tissue available for histologic evaluation and confirmation of organ of origin.
* Patients must be enrolled no more than twelve weeks postoperatively.
* Patients must be willing to receive their chemotherapy drugs intravenously, as intraperitoneal therapy is not part of this trial.

Key Exclusion Criteria:

* Patients with a current diagnosis of epithelial ovarian tumor of low malignant potential (Borderline carcinomas) are not eligible.
* Patients who have received prior radiotherapy to any portion of the abdominal cavity or pelvis are excluded
* Patients who have received prior chemotherapy for any abdominal or pelvic tumor are excluded
* With the exception of non-melanoma skin cancer and other specific malignancies patients who had (or have) any evidence of the other cancer present within the last 5 years or whose previous cancer treatment contraindicates this protocol therapy are excluded.
Characteristics of Injury Claims by Chronic Pain Patients

Chronic pain is associated with injuries and disabilities. This prospective observational study explores the injury or disability claims made by chronic pain patients. It evaluates the socio-demographics of the patient population. It explores the impact of pain clinic services on the patients' injury rehabilitation, insurance claim outcome, and socioeconomic situation.

Chronic pain is associated with injuries, disabilities, psychological disorders, and unemployment. Chronic pain patients usually make insurance claims for injury, disability, and unemployment.

This prospective observational study explores the injury, disability, and compensation claims made by chronic pain patients. The study evaluates the socio-demographics of the patient population; including their gender, age, ethnicity, occupation, employment status, income, education level, family status, and home location. It explores the impact of pain clinic services on the patients' injury rehabilitation course, insurance claim outcome, and socioeconomic situation.

Eligibility Criteria:
Inclusion Criteria:

* adult chronic pain patients
* patients with injury claim

Exclusion Criteria:

* pediatric patients
* patients without injury claim
Trifluridin/tipirACil in MeTastatIc Colorectal Cancer

A non-interventional, prospective, open, multicenter study in Germany in patients with metastatic colorectal cancer who have been previously treated with, or are not considered candidates for, available therapies and with decision for treatment with trifluridin/tipiracil.

The purpose of this NIS, after market approval of trifluridin/tipiracil as treatment for mCRC patients who have been previously treated with, or are not considered candidates for, available therapies, is to evaluate effectiveness, QoL, treatment details and safety of trifluridin/tipiracil treatment in a real-world setting. In addition, therapy management and health economic parameters regarding trifluridin/tipiracil treatment will be assessed.

Eligibility Criteria:
Inclusion Criteria:

* Aged 18 years or older.
* Patients with mCRC who have been previously treated with, or are not considered candidates for, available therapies including fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapies, anti-VEGF agents, and anti-EGFR agents.
* Indication for treatment as assessed by the treating physician.
* Decision for treatment with trifluridin/tipiracil.
* Signed written informed consent.
* Criteria according to current Summary of Product Characteristics (SmPC) for patients treated with trifluridin/tipiracil.
* Ability to read and understand German.

Exclusion Criteria:

* Contraindications according to SmPC for metastatic colorectal cancer patients treated with trifluridin/tipiracil.
* Participation in a clinical trial within 30 days prior to enrollment or simultaneous participation in a clinical trial.
The Effect of Time-Slot Scheduling and Active Choice on Biometric Screening Participation

The goal of this project is to see if behavioral nudges will increase an individual's likelihood of participating in a biometric screening. The behavioral nudges under consideration are assigning preselected time-slots, encouraging subjects to make an active choice, and sending reminders.

The employees in our sample will schedule their time slot for a biometric screening via e-mail and a health service provider website. Much as is the case in the current system, the control group will be informed via e-mail of the window of dates during which they can take part in the on-site screening and given instructions for scheduling an appointment. The first treatment group, the active choice and default option arm, will be informed via e-mail of a preselected time and date for their screening, which we will have generated randomly. This group will be asked to accept the default time, schedule a different time, defer the scheduling decision, or decline to receive a screening by clicking the appropriate option in the email. The second treatment group, the active choice only arm, will be given the same information as the control group, but they will also be asked to make an appointment immediately, defer the scheduling decision, or decline to receive a screening. The two treatment groups will also receive email reminders one week before their appointment and again one day before their appointment.

Eligibility Criteria:
Inclusion Criteria:

* Employee of Express Scripts
* Employee at a targeted Express Scripts location

Exclusion Criteria:

* Non-employees of Express Scripts
Role of Calcium And Vitamin D In Nutritional Rickets And It's Management

Rickets, a common nutritional disorder, is usually considered to be due to vitamin D deficiency. However, in the last few decades many studies have shown that in tropical countries, with abundance of sunshine, calcium deficiency may play a more important role in the causation of rickets. Studies from adults in India have also shown that calcium intake of our population is much below the recommended allowance. The calcium deficiency gets compounded by the high level of phytates in the conventional vegetarian diet consumed by the majority of the population. There are few studies on children in India / other Asian countries on assessment of dietary calcium intake.

However, recent studies from many nations of the world have also shown a wide spread prevalence of vitamin D deficiency in adolescent and adult population. A study done at our own hospital has shown a high prevalence of vitamin D deficiency in lactating mothers and their infants.

Since both Calcium and Vitamin D deficiency are likely to be present in children, it is not clear what plays a more important role in the etiology of rickets in India or other Asian countries.

The present study is therefore planned with the following objectives:

1. To study the dietary calcium intake, sun exposure and serum vitamin D levels in children with and without rickets.
2. To compare the role of Calcium Carbonate, Vitamin D and a combination of the two in the treatment of nutritional rickets.


Eligibility Criteria:
Inclusion Criteria:

* children aged 6 months to 5 years with rickets

Exclusion Criteria:

* Non nutritional cause of rickets
* taken vitamin D or calcium supplements in last 6 months
* children presenting with convulsions
Moderate to Persistent Asthma in the Obese Subject

Obesity is associated with increased airway inflammation and asthma severity that results in suboptimal control of asthma despite therapy with high dose inhaled corticosteroids (ICS). The investigators suggested that the addition of Singular (montelukast)\[LTRA\] to moderate doses of inhaled corticosteroids will improve asthma control. This cross over study will be treat subjects with moderate dose ICS/LTRA for 12 weeks and high dose ICS with placebo for 12 weeks.

Subjects will enter the 2-week run-in period after meeting eligibility criteria at the screening visit (visit 1). During run-in subjects will have all usual asthma medications discontinued and will be placed on inhaled corticosteroids at moderate doses and leukotriene receptor antagonists will be withdrawn (LTRA wash-out). Subjects will be monitored to rule out any acute infection or symptoms consistent with an exacerbation. The run-in period will be used to assess subject compliance and understanding of study related procedures. Following the run-in, to be eligible for the randomization subjects must have an ACQ score \>1.25 on the Juniper Asthma Control Questionnaire.

Eligibility Criteria:
Inclusion Criteria:

* moderate persistent asthma as defined daily symptoms, nocturnal awakenings \>1 time/week but not daily, daily short-acting beta agonist usage
* pre-bronchodilator Force expiratory volume (FEV1)\>55% but \<90%.
* Subjects must be on controller therapy for asthma with ICS for at least one month prior to enrollment.
* methacholine testing that causes a drop in the FEV1 of 20% (8mg/ml off ICS or 16mg/ml) on ICS within 6 months prior to entry
* physician diagnosis of asthma for at least one year prior to study enrollment.
* Obesity defined as BMI greater than 30.
* subjects must have an Asthma Control Questionnaire (ACQ) score \>1.25 on the Juniper Asthma Control Questionnaire (indicating poor asthma control),
* require daily medications for asthma and be compliant with study related medications.

Exclusion Criteria:

* Subjects must not have been intubated in the last 5 years or unstable asthma symptoms resulting in significant loss or work or school
* upper or lower respiratory tract infection within 1 month of the study
* use of antibiotics within 4 weeks of the study
* use of oral glucocorticoids within 4 weeks
* use of theophylline
* smoking history greater than 10 pack years or any cigarette use within the past two years
* significant non-asthma pulmonary disease or other medical problems
* Subjects planning to undergo gastric bypass surgery within 4 months of the enrollment date will be excluded since weight loss is a potential confounder of asthma control
* Pregnant women will also be excluded
Morphine or Ketamine for Analgesia

Pain is common in children presenting to the emergency department but is frequently undertreated, leading to both short- and long-term consequences. Morphine is the standard treatment for children with moderate to severe acute pain, but its use is associated with serious side effects and caregiver and clinician concerns related to opioid administration. The investigators aim to determine if sub-dissociative ketamine is non-inferior to morphine for treating acute pain and a preferable alternative for treating acute pain in children because of its more favorable side effect profile and potential long-term benefits related to pain-related function, analgesic use/misuse, and mental and behavioral health outcomes.

Aim 1: To determine if IV sub-dissociative ketamine is non-inferior to IV morphine for decreasing pain intensity in children presenting to an ED with acute pain. The investigators hypothesize that IV sub-dissociative ketamine is non-inferior to IV morphine for decreasing pain intensity in children with acute abdominal pain or an extremity fracture.

Aim 2: To compare the rate of acute (\<2 hours) adverse events, including cardiopulmonary adverse events, associated with IV sub-dissociative ketamine and IV morphine. The investigators hypothesize that there is a smaller proportion of cardiopulmonary adverse events associated with IV sub-dissociative ketamine compared to IV morphine.

Aim 3: To determine the relationship between ketamine and long-term sequelae of acute pain. The investigators hypothesize that children who receive ketamine will have better levels of pain-related function during the first week following ED presentation and will have greater odds of experiencing more favorable post-traumatic stress, anxiety and depression outcomes 1-6 months after ED presentation compared to children who received IV morphine.

Eligibility Criteria:
Inclusion Criteria:

1. Abdominal pain or isolated long-bone extremity fracture (suspected or proven)
2. Self-reported pain score of ≥ 6/10
3. Requires IV morphine for analgesia as determined by the treating physician

Exclusion Criteria:

1. Weight \> 82.4 kg
2. Known allergy/contraindication to morphine or ketamine
3. Antecedent receipt of ketamine related to presenting complaint
4. Inability to use self-report measures of pain or questionnaires
5. Chronic disease associated with pain
6. Chronic pain condition requiring use of opioids as outpatient
7. Hemodynamic instability or critical illness per treating physician
8. Altered mental state (e.g., GCS , 14 or clinical intoxication)
9. Known history of schizophrenia, liver or kidney problems, or osteogenesis imperfecta
10. Concern for open fracture, neurovascular compromise, or compartment syndrome
11. Injuries in addition to the extremity injury (e.g., head, neck, abdomen)
12. Known or reported pregnancy
13. Does not speak English or Spanish
14. Patient previously enrolled in this study
15. Wards of state, foster children, or children in custody
Early and Systematic Shoulder Rehabilitation Following Cervical Lymph Node Dissection

A prospective, monocentric, controlled, randomized study of systematic early shoulder rehabilitation following cervical lymph node dissection for the prevention and treatment of shoulder dysfunction.

Pre-inclusion: information, collection of consent, collection of antecedents and biometric data, clinical examination (goniometric measurement and visual analogic scale of pain), collection of DASH, EORTC QLQ-C30 and H\&N35 questionnaires.

Surgical intervention (J0) and randomization into 2 groups:

Group 1 - systematic early rehabilitation Group 2 - without systematic rehabilitation

M3, M6, M12: collection of complications, adjuvant treatments, number of physiotherapy sessions performed, clinical examination (goniometric measurement and visual analogic scale of pain), collection of DASH, EORTC QLQ- C30 and H\&N35 questionnaires.

Eligibility Criteria:
Inclusion Criteria:

* Proficiency in the oral and written French language
* unilateral or bilateral cervical lymph node dissection preserving the accessory spinal nerve
* Karnofsky index ≥ 80%
* Age ≥ 18 years

Exclusion Criteria:

* cognitive disorders
* predictable difficulties in compliance with treatment and/or follow-up
* pre-existing pathology involving shoulder and its mobility, independent of head and neck cancer
* comorbidity preventing rehabilitation of the shoulder
* time to start rehabilitation after 6 weeks postoperatively
* pregnant women
* minors
* majors under guardianship
* refusal to participate in the study
Bioequivalence Study of Carbidopa/Levodopa/Entacapone Combination vs. Carbidopa/Levodopa Combination Plus Entacapone in Healthy Volunteers

The purpose of this study is to assess the safety and bioequivalence of a single oral dose of carbidopa+levodopa+entacapone combination versus a single oral dose of carbidopa+levodopa combination plus a single oral dose of entacapone under fasting conditions in healthy volunteers.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male and female subjects age 18 to 55 years of age included, and in good health
* At Screening, and Baseline, vital signs (systolic and diastolic blood pressure and pulse rate) will be assessed after the subject has rested for at least five (5) minutes, and again when required after three (3) minutes in the standing position. Vital signs should be within the normal ranges
* Body mass index (BMI) within the range of 18 to 27 and weigh at least 50 kg
* Female subjects must have undergone hysterectomy, or must be postmenopausal.

Exclusion Criteria:

* History or presence of significant cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, or psychiatric disease
* History of malignancy of any organ system, treated or untreated, within the past 5 years whether or not there is evidence of local recurrence or metastases, with the exception of localized basal cell carcinoma of the skin
* Receiving monoamine oxidase (MAO) inhibitors within 28 days prior to the first dose
* A positive Hepatitis B surface antigen (HBsAg) or Hepatitis C test result
* History of clinically significant drug allergy or history of atopic allergy (asthma, urticaria, eczematous dermatitis). A known hypersensitivity to the study drug or drugs similar to the study drug.
* Significant illness within two weeks prior to dosing
* Subjects who, through completion of the study, would have donated in excess of: 500 mL of blood in 14 days; 1500 mL of blood in 180 days; 2500 mL of blood in 1 year.
* History of immunodeficiency diseases, including a positive HIV (ELISA and Western blot) test result.
* History of drug or alcohol abuse within the 12 months prior to dosing or evidence of such abuse as indicated by the laboratory assays conducted during the screening or baseline evaluations.
* Women of child bearing potential ( WOCBP)
* History or presence of glaucoma or any suspicious undiagnosed skin lesions

Other protocol-defined inclusion/exclusion criteria may apply