cyrilzakka/clinical-trials huggingface dataset:
Recognizing Pain Intensity in Alzheimer's Disease

The most common form of dementia is Alzheimer's disease, with 900,000 people affected in France in 2015 and a forecast of 1.3 million in 2020. As a consequence of their advanced age, dementia patients often suffer from pain, mainly musculoskeletal or neuropathic pain. However, the exact prevalence of pain in dementia is underestimated. Indeed, several studies indicate that people suffering from dementia report less pain. This phenomenon is all the more true as the stage of dementia is advanced. In addition, people with dementia receive less pain medication than people without cognitive impairment in similarly painful conditions. Hetero-evaluation alone also seems insufficient, with the result that pain is under-treated compared to patients without cognitive impairment. Better pain screening is a major challenge and self-assessment tools should be favoured as a first line of treatment, even for patients with cognitive impairment. suffering from dementia.

The investigators propose in this work to evaluate the variation of vegetative parameters that accompany a painful stimulus. These variations can be recorded at the cardiac, vascular, pupillary or skin conductance level.

It will therefore be a question of inducing experimental pain in patients with Alzheimer's disease, in the early stages of the disease and to check whether pain-related changes in the autonomic nervous system via the Nociception Level index (NoL® system) differ from a control group of subjects matched in age, gender and education level. To induce pain, the investigators will use the "cold pressor test" technique, which consists of leaving the arm immersed in ice water for as long as the pain is bearable. The investigators will also record before, during and after the immersion, the variations of several parameters derived from the autonomic nervous system during the painful stimulation via the NoL® system. During this experience, the participants will be filmed in their entirety to observe the facial emotions related to pain.

Eligibility Criteria:
Inclusion Criteria for patients with alzheimer's disease :

* Diagnosis of the disease by a hospital doctor after an etiological assessment including at least a cerebral MRI, a neuropsychological assessment and, if possible, dementia markers in the cerebrospinal fluid.
* Mini Mental State Score \> 23

Inclusion Criteria for control subject :

- Matching by age (± 5 years), gender, and grade level

Exclusion Criteria for 2 groups :

* presence of pain,
* Presence of mood and/or psychiatric disorders (HAD A ou A scores \>7).
* Presence of cardiovascular risk factors and beta-blocker and/or calcium channel blocker therapy.
* Patients under guardianship or curatorship
Optimal Dose of Incisional Local Infiltration Betamethasone for the Prevention of Pain After Spinal Surgery

Incisional pain is a common complication after surgery and is an important cause of delayed postoperative recovery, increased length of hospital stay, increased risk of wound infection and respiratory/cardiovascular complications, as well as an important medical, social, and economic problem. Prevention and treatment of postoperative incision pain remains challenging. Local Infiltration Anaesthesia (LIA) for surgical incisions with an anti-inflammatory and analgesic combination has been reported to be effective in reducing postoperative pain, but there is a gap in the research on the optimal concentration of anti-inflammatory drugs in the anti-inflammatory and analgesic combination during local infiltration. The aim of this study was to investigate the optimal concentration of anti-inflammatory drugs in the anti-inflammatory-analgesic combination solution used for local infiltration of spinal surgical incisions to prevent postoperative pain.


Eligibility Criteria:
Inclusion Criteria:

Patients scheduled for spine surgery under general anesthesia. Anticipated cervical, thoracic, and lumbar spine surgeries (within three level).

Patients age 18-65 years. American Society of Anaesthesiologists Classification of I or II.

Exclusion Criteria:

Patients refuse to participate. Patients who are allergic to ropivacaine, betamethasone and opioid, . Pateints who have been abusing drugs or alcohol. Patients who have abnormalities in kidney or liver function tests. BMI\<15kg/m2 or\>35 kg/m2. Patient has a history of spinal surgery. Patient has peri-incisional infection. Patient has a history of stroke or other serious neurological disease. Patient has a history of diabetes and other metabolic disorders. Patient has a history of psychological disorders. Patient is on systemic steroids. Patient is pregnant or breastfeeding. Glasgow Coma Scale score \< 15 before surgery. Unable to provide written informed consent.

Withdrawal criteria:

Voluntary withdrawal. Delayed extubation. Poor cognitive function within 48 hours after surgery. Postoperative radiation therapy or chemotherapy during follow-up. Postoperative diagnosis of spinal cord or nerve root injury resulting in pain during follow-up.

Reoperation during follow-up.
Naturalistic Study Into the Hangover Effects of MDMA

The aim of the study is to compare hangover effects of MDMA users versus those who used other drugs, or alcohol only at New Year's Eve. The week after New Years Eve, every day participants complete a questionnaire about the presence and severity of potential hangover symptoms. At day 1, demographics and alcohol and drug use at New Years Eve were recorded. On day 7, the Brief Symptom Inventory (BSI) is completed to asses last weeks mood. After 4 weeks, after a drug-free week, the BSI is completed again to serve as a reference.

A convenience sample was invited by e-mail to participate in the study, via the organizer of a private New Years Party.It was attempted to include as much participants as possible. Hence, no sampling method was applied when recruiting participants.

Eligibility Criteria:
Inclusion Criteria:

* poly drug user
* 18+ years old

Exclusion Criteria:

* mental or physical illness
Assessments in Stress and Quality of Sleep/Life in Night-shift Nurses and Doctors

This study aims to evaluate the effects of aroma massage to sleep quality of the nurses and staff during night shift.

Night shift increases physical and psychological pressure, and even affects their sleep quality. This study aims to evaluate the effects of aroma massage to sleep quality of the nurses during night shift after life-style modification and/or aroma massage. The investigators adopt a Randomized Controlled Trial (RCT) in this study. The investigators expect aroma massage would improve the sleep quality during night shift.

Eligibility Criteria:
Inclusion Criteria:

* Shift-Work Nurses and Staff

Exclusion Criteria:

* Diabetes mellitus, cardiovascular disease and psychological disorders
Molecular Network Characteristics of Phlegm-heat Syndrome in Ischemic Stroke Based on Multi-omics Integrated Analysis

The molecular characteristics of ischemic stroke with phlegm-heat syndrome and candidate biomarkers were identified based on multi-omics data. The main purpose of this study is to validate the molecular characteristics and biomarkers of phlegm-heat syndrome in ischemic stroke, and to demonstrate the association of biomarkers with clinical outcomes.

This is a cohort study in patients with ischemic stroke. The demographic characteristics, TCM syndromes, and other baseline information will be recorded. At the same time, baseline peripheral blood will be collected. These participants will be followed up to 90 days of onset, and 90-day modified Rankin scale (mRS) scores will be assessed. The collected blood samples will be tested by multi-factor detection technology for candidate biomarkers.

Eligibility Criteria:
Inclusion Criteria:

* Acute ischemic stroke, were confirmed by magnetic resonance imaging (MRI).
* Symptom onset within 72 hours.
* Diagnosis of phlegm-heat syndrome or non-phlegm-heat syndrome.
* Male or female ≥ 50 years and ≤ 80 years.
* With written informed consent.

Exclusion Criteria:

* Planned or already receiving intravenous thrombolysis or endovascular treatment.
* Acute infectious diseases or acute exacerbations of chronic diseases within one month before enrollment.
* Patients with previous stroke.
* Renal or hepatic insufficiency, tumors, immune diseases, severe underlying diseases.
* Other conditions that may affect the collection and evaluation of clinical information (e.g., severe aphasia, mental illness).
Evaluate the Efficacy, Safety and Pharmacokinetics of GSK1325760A in the Treatment of Pulmonary Arterial Hypertension

The primary objective of this study is to evaluate the effect of GSK1325760A on improvement in exercise capacity in subjects with pulmonary arterial hypertension (PAH).

The secondary objectives of this study are to evaluate administration of GSK1325760A on:

* The safety and tolerability
* Improvement of PAH
* The steady-state plasma pharmacokinetics of GSK1325760A


Eligibility Criteria:
Inclusion criteria:

* Subjects must have a diagnosis of Pulmonary Arterial Hypertension (PAH) in clinical classification of Pulmonary Hypertension Group1
* The mean right heart catheterization parameters measured from 6 months prior to the administration of the investigational drug must meet the criteria below:
* Mean pulmonary arterial pressure (mPAP) of \>25 mmHg
* Pulmonary vascular resistance (PVR) of \>3 mmHg/L/min
* Mean pulmonary capillary wedge pressure or left ventricular end diastolic pressure of \<15 mmHg (if measurable)
* The measured six minutes walk distance (6MWD) at screening visit is in the range of =\>150m and \<=450m
the Efficency and Safety of Stretta in GERD

This study evaluated the efficency and safety of the endoscopic radiofrequency procedure(Stretta) in adult gastroesophageal patients.

Gastro-esophageal reflux disease (GERD) is the most common outpatient diagnosis in gastroenterology and is associated with a significant burden on the healthcare system. Proton pump inhibitors (PPIs) are the mainstay of GERD treatment,howerver, some patients have an unsatisfactory response to high doses of PPIs, which remains a challenge. The Stretta procedure, a radiofrequency (RF) application to the lower esophageal sphincter (LES), was introduced about 15 years ago as an alternative to chronic medical therapy or surgical intervention for GERD.The Stretta procedure appears to result in thickening of the LES, decreased transient LES relaxation rate and reduced esophageal acid exposure.The majority studies of Stretta were held in USA and Europe, the sduty of Stretta in Asia is rare. The investigators propose to perform a prospectively observiton study to evaluate the efficency of the Stretta procedure in patients of refractory GERD in China.

Eligibility Criteria:
Inclusion Criteria:

1. Age \> 18 years
2. Small hiatus hernia (\< 2-3 cm)
3. Los Angeles Grade 'A' or 'B' Reflux Esophagitis or non erosive esophagitis
4. LES pressure \<15 mm Hg
5. PPI dependent / refractory GERD
6. abnormal 24h esophagus pH-impedance monitoring

Exclusion Criteria:

1. Age \< 18 years
2. Large hiatus hernia (\> 3 cm)
3. Los Angeles Grade 'C' or 'D' Reflux Esophagitis
4. LES pressure \> 15 mm Hg
5. Underlying coagulation disorder
6. Previous Esophageal or Gastric surgery
7. Pregnant
8. major esophagus motility disorder according to Chicago v3.0
Evaluation of AVE5026 in the Prevention of Venous Thromboembolism in Acutely Ill Medical Patients With Restricted Mobility

The primary objective was to compare the efficacy of once daily \[q.d\] subcutaneous \[s.c.\] injections of Semuloparin sodium (AVE5026) with q.d. s.c. injections of Enoxaparin for the primary prevention of Venous Thromboembolic Events \[VTE\] in patients hospitalized for acute medical illness.

The secondary objectives were to evaluate the safety of AVE5026 and to document AVE5026 exposure in this population.

Randomization had to take place just prior to the first study drug injection.

The total duration of observation per participant was 35-42 days from randomization broken down as follows:

* 10 to 14-day double-blind treatment period;
* 25 to 32-day follow-up period.

Mandatory bilateral compression ultrasound \[CUS\] had to be performed between 10 to 15 days after randomization.

Eligibility Criteria:
Inclusion Criteria:

Patient with an acute medical condition requiring bed rest for at least 3 days, and hospitalized for at least one of the following medical conditions:

* Congestive heart failure (New York Heart Association \[NYHA\] class III/IV);
* Acute respiratory failure (not requiring mechanical ventilation);
* Acute infection (without septic shock)\*;
* Acute rheumatic disorder\*;
* Acute episode of inflammatory bowel disease\*.

  * Patient with one of these conditions should have at least one additional risk factor for venous thromboembolism (VTE) among the following:

    * Age ≥ 75 years;
    * Active cancer or myeloproliferative disorders (having received treatment for cancer within the last 6 months);
    * Previous VTE;
    * Obesity;
    * Oral hormone therapy (antiandrogen or estrogen);
    * Chronic heart failure;
    * Chronic respiratory failure.

Exclusion Criteria:

* Previous surgery with general anesthesia within 30 days before inclusion in the study;
* Patient requiring a curative anticoagulant or thrombolytic treatment;
* Patient at risk of bleeding;
* Stroke;
* Known hypersensitivity to heparin or enoxaparin sodium;
* End stage renal disease or patient on dialysis.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
SYNCHRONOUS AND ASYNCHRONOUS TELEREHABILITATION METHODS IN PATIENTS WITH CERVICAL DISC HERNIATION

This was a randomized controlled trial conducted to examine the changes in the pain, physical function, quality of life, and kinesiophobia of participants with non-specific neck pain in Marmara University Physiotherapy and Rehabilitation Department. This study was approved by the Clinical Studies Ethics Committee of Marmara University Faculty of Health Sciences in January 2022 and was carried out in accordance with the Declaration of Helsinki. The participants were informed about the study and their consent was obtained.


Eligibility Criteria:
Inclusion Criteria:

* Participants between the ages of 18-65,
* Who had access to the internet and smartphone,
* Had the ability to conduct video calls were included in the study.

Exclusion Criteria:

* Participants were excluded if they had COVID-19,
* Had surgery in the last 6 months,
* Received physiotherapy treatment.
* Had a condition that prevented them from exercising.
Study Evaluating Safety & Immunogenicity of rLP2086 Vaccine in Adolescents

Study to evaluate the safety of an investigational meningitis vaccine and the immune response to it in adolescents


Eligibility Criteria:
Inclusion Criteria:

Inclusion Criteria

* Aged 8 to 14 years at the time of enrollment.
* Healthy male or female subjects
* Negative urine pregnancy test for female subjects

Exclusion Criteria:

Exclusion Criteria

* Prior vaccination with a meningococcal B vaccine
* Prior meningococcal disease
Efficacy of Single-Shot Dexmedetomidine Versus Placebo in Preventing Pediatric Emergence Delirium in Strabismus Surgery

This study is trying to see if using precedex pre-operatively prevents emergence delirium in pediatric (ages 1-7) patients undergoing strabismus surgery.

Emergence delirium (ED) is a complex behavioral disturbance characterized by psychomotor agitation, perceptual disturbances, delusions, and disorientation during recovery from general anesthesia. In the population of subjects who undergo strabismus surgery, there are multiple factors that may increase the risk of ED. These include age, typically preschool children aged 1-7 years, rapid surgical times with rapid awakening, use of sevoflurane as the primary anesthetic, and surgically-induced postoperative visual disturbance. The aims of this study are: 1) To examine whether post-induction treatment with an α-2 receptor agonist, precedex (dexmedetomidine), decreases postoperative emergence agitation after strabismus surgery compared to placebo, and 2) to determine whether treatment has any effect on postoperative pain, nausea/vomiting, number of pain-related interventions, and time to PACU discharge. We hypothesize that precedex will attenuate the ED response greater than placebo or a lower dose after strabismus surgery and will reduce PACU pain scores without increasing PACU length of stay.

Inclusion:

i. Pediatric patients aged 1-7 years of age ii. American Society of Anesthesiologists (ASA) physical status I-II iii. No significant laboratory abnormalities

Exclusion:

i. Presence of medicated behavioral disorder ii. Subjects for which precedex, opiates, benzodiazepines, or inhalational anesthetics are contraindicated iii. Parental refusal

Eligibility Criteria:
Inclusion Criteria:

* ASA physical status of I or II
* male or female, aged 1-7
* has no significant lab abnormalities

Exclusion Criteria:

* ASA physical status of III, IV or V
* Presence of medicated behavioral disorder
* Subjects for which dexmedetomidine, opiates, benzodiazepines or inhalational anesthetics are contraindicated.
* Parental refusal
DEPS-R Turkish Version in Adults With Type 1Diabetes

A growing body of research has revealed the good psychometric properties and three-component factor structure of DEPS-R in children and adolescents with type 1 diabetes (T1D) but research with adults has limited and has differing results. The Diabetes Eating Problem Survey-Revised (DEPS-R) developed by Markowitz et al is a diabetes-specific self-report instrument to screen eating disorders for individuals with T1D. DEPS-R is a 16-item diabetes-specific self-report questionnaire to test for diabetes-specific eating disorders. Answers are scored on a six-point Likert scale, with higher scores indicating more DEB and a total score of ≥20 indicating a high risk for eating disorders (range 0-80). The original DEPS-R has been shown to have a good internal consistency (Cronbach's alpha=0.86) and construct validity in a sample of the pediatric population with T1D. This study aimed to evaluate the validity and reliability of the Turkish version of the DEPS-R questionnaire for adults with T1D, investigate its psychometric properties and factor structure, and examine its relationship with the EDE-Q questionnaire.

In this cross-sectional study, participants answered a DEPS-R and EDE-Q questionnaire during a regularly scheduled medical visit after obtaining written informed consent. All participants had established that patients with T1D were treated with multiple daily insulin or insulin pump therapy. Height was measured using a stadiometer to the nearest 0.1 cm in all participants. Weight was measured unclothed to the nearest 0.1 kg using a calibrated balance scale. Body Mass Index (BMI) was calculated by using the weight (kg)/height (m²) equation. Clinical data including HbA1c, T1D onset, birth date, and treatment model etc. was conducted as part of a standard clinical assessment. HbA1c was measured with ion-exchange high-performance liquid chromatography (Bio-rad Variant ll Turbo, Japan).

Eligibility Criteria:
Inclusion Criteria:

* Duration of T1D ≥1 year
* A regular follow-up for at least 1 year (4 visits/year)
* No major medical problems related to nutrition

Exclusion Criteria:

* Have major medical problems related to nutrition ( etc. celiac disorders, cystic fibrosis, dyslipidemia,.....)
Effects of CIMT With and Without MIT on Upper Limb of Children With Hemiparetic CP

Cerebral Palsy (CP) is a major cause of motor disability in children. Among these CP children, approximately one third have hemiparetic cerebral palsy. Hemiparetic cerebral palsy is more impairment of one side of the body as a result of non-progressive disturbances in premature brain.To determine the effects of implementing a practice period of modified constraint induced movement therapy in a virtual environment on hand function in chidren with hemiparetic cerebral palsy.

To determine the effects of implementing a practice period of modified constraint induced movement therapy in a virtual environment on hand function in chidren with hemiparetic cerebral palsy.The term Modified constraint-induced movement therapy is a form of rehabilitation therapy that limits the less paretic side, and through repeated and concentrated training improve the upper limb function of the paretic side. Motor imagery is a cognitive process in which a subject imagines that he or she performs a movement without actually performing the movement and without even tensing the muscles. Modified Constraint induced movement therapy can be utilized in both the lower and upper extremities with the motor imagery technique for psychological or occupational therapy and in affecting which one is better for speedy recovery.

Eligibility Criteria:
Inclusion Criteria:

* Age 6 to 14 years were included.
* Diagnosed of hemiparetic cerebral palsy and typically developing controls.
* Both gender is included i-e, male and female.
* Children included having motor impairments of upper limb.
* All children had normal or corrected vision and the ability to discriminate between right and left.

Exclusion Criteria:

* History of neurosensory and neuropsychiatric impairments.
* Presence of contractures in the affected upper limb.
* Surgery in the previous six months.
* Uncontrolled epilepsy
L-CARnitine in the Palliative Treatment of Advanced PANcreatic Cancer (CARPAN)

The study investigated the role of L-Carnitine supplementation on proinflammatory immune response, malnutrition, cancer cachexia and cancer related fatigue in advanced and inoperable pancreatic cancer, UICC Stage IV .

Pancreatic cancer has the lowest 5-year survival rate of any cancer and ranks as the fourth leading cause of cancer death world wide. Several metabolic changes are present in the whole body in case of cancer so the investigators conducted a placebo controlled, double blinded, randomized, prospective and multicentre study to investigate, whether L-Carnitine supplementation may have an impact on malnutrition, cancer cachexia and cancer related fatigue in advanced pancreatic cancer.

Study drug: L-Carnitine 4g per day (vers) Placebo Study design: A multi-centre, double blind, and placebo-controlled, randomised, parallel group study

Patient population: Patients with advanced pancreatic carcinoma Number of patients: Total of 90 patients in two equal groups number of centres: 4 (Greifswald, Magdeburg, Berlin,Heidelberg,all Germany) Duration of dosing: 12 weeks

Eligibility Criteria:
Inclusion Criteria:

* advanced pancreatic cancer (UICC Stage IV)
* Karnofsky Index larger than 60
* compliance
* consent to participate to the study

Exclusion Criteria:

* Child-Pugh classification of liver failure greater than Child B,
* a known second malignant tumor
* oral or parenteral supplementation with omega-3-fatty acids
* treatment with thalidomide or Infliximab
* mental or physical disorders