cyrilzakka/clinical-trials huggingface dataset:
Pain Perception of People Who Are Unable to Have Headache

Headaches are extremely common illnesses with a combined lifetime prevalence of 90-99% in Europe. Despite this high prevalence, there are persons who have never, in their whole life, encountered a headache.

The aim of the study is to identify factors that protect against headache by studying pain perception, muscle tenderness and pain tolerance in people who never have had a headache (headache resistant) versus non-resistant controls.

The investigators hope to contribute with novelty to the current understanding of headache pathophysiology and development of more efficient treatment of headache.

The investigator examining:

Quantitative sensory testing (cold pain threshold and heat pain threshold), Muscle tenderness (total tenderness score) and cold pressor test (time in the water and pain rating). All tests are performed the same day, by one investigator who are blinded to the grouping of the participants.


Eligibility Criteria:
Inclusion Criteria:

* Headache resistant and non-resistant male participants from the Danish Blood Donor Study.
* Weight: 45 kg to 95 kg

Exclusion Criteria:

* Daily consumption of any medication.
* Consumption of any medication less than 12 hours prior to the study day.
* Headache on the study day or 48 hours prior to the study day.
* Amnestic or clinical signs of hypertension (systolic blood pressure \>150 mmHg and/or diastolic blood pressure \>100 mmHg) or hypotension (systolic blood pressure \<90 mmHg and/or diastolic blood pressure \<50 mmHg).
* Any severe cardiovascular disease, including cerebrovascular illness.
* Amnestic or clinical signs of current mental illness.
* Amnestic or clinical signs of current substance or drug abuse.
* Amnestic or clinical signs of any illness the responsible doctor considers relevant for participation in the study.
Different Chemotherapy Protocols Combined With Intensity Modulated Radiation Therapy in Patients With Locally Advanced Nasopharyngeal Carcinoma

This study was to evaluate the efficacy ,toxic reaction and safety of different chemotherapy combined with radiotherapy on patients with locally advanced nasopharyngeal carcinoma.


Eligibility Criteria:
Inclusion Criteria:

* Patients \> 18, \<70 years old, with locally advanced nasopharyngeal carcinoma.

Exclusion Criteria:

* patients who had accepted radiotherapy before patients with any ather types of cancer
Female Sex is an Independent Predictor of Death and Bleeding Among Fibrinolytic Treated Patients With AMI

This study evaluated differences between men and women in the presentation, management and outcome of heart attacks within the GUSTO V study.

The Global Use of Strategies to Open Occluded Arteries in Acute Coronary Syndromes (GUSTO) V trial examined a large, contemporary cohort of women and men with ST elevation myocardial infarction (STEMI) treated with fibrinolytic therapy. The objective of the present study was to evaluate sex differences in presentation, management and outcome in GUSTO V.

Eligibility Criteria:
Inclusion Criteria:

* inclusion into GUSTO V

Exclusion Criteria:

* lack of availability of data (database study)
Lifestyle Intervention for Healthy Change

The purpose of this study is to determine the effectiveness of a physician led, multi-disciplinary approach to treating obesity that incorporates nutrition (mainly, using genetics to identify appropriate food intake), exercise, and motivational counseling. The investigators plan to recruit overweight/obese (BMI\>25) males and females to participate. Participants will be randomized to receive a personalized diet plan, or a standard care diet plan; both groups will participate in the exercise intervention. For a 6-month duration, both groups will be asked to improve their diet according to their dietary plan and participate in moderate-to-vigorous physical activity (gradual increase up to 300 min/week). The investigators intend to evaluate standard outcomes of weight loss, and assess for any predictors of positive outcomes. Following the six-month intervention, participants will complete a 3-month no contact phase. This no contact phase will provide insight into the effects of the study on weight loss maintenance. Our team also plans to address acceptability by providing evaluations to study participants and conducting interviews with a small subset of participants to improve the intervention for the future.


Eligibility Criteria:
Inclusion Criteria:

* Age 18-40 years
* BMI \> 25 kg/m2
* No cardiopulmonary disease
* stable on medications for 3 months
* weight stable (+/-5 pounds) for the past 3 months
* Not pregnant or trying to get pregnant
* Owns a smartphone
* Able to walk unassisted
* Not on supplemental oxygen

Exclusion Criteria:

* Under the age of 18 years
* 40 years and older
* Unable to participate in an exercise program
* Currently pregnant
Mindfulness Meditation for Health

The purpose of this 52-week clinical trial is to see if the meditation-based intervention, adjunctive to standard of care therapy, can reduce relapse and improve psychological health among adults recovering from alcohol dependence.

The goal of this partially-blinded, two-arm clinical trial was to test whether the Mindfulness Meditation Relapse Prevention (meditation), combined with 'standard of care' (SOC) therapy, is more effective in preventing a return to drinking than SOC alone (wait-list control) among adult recovering alcoholics. The intervention was manualized and based on existing models. It was proposed that meditation may improve outcomes of interest through reduction of the severity of stress-related relapse risk factors such as perceived stress, anxiety, depression, craving and emotion dysregulation, and the level of stress-sensitive biomarkers (cytokine interleukin-6, liver enzymes).

For this study, 123 adult alcohol dependent subjects were recruited from collaborating treatment centers, randomly assigned to one of two equal study arms, and followed for 26-weeks (Period 1, Randomized Controlled Trial, RCT). The RCT evaluated the efficacy of the meditation intervention using self-reported alcohol consumption as primary, and drinking-related harms and subject treatment satisfaction and adherence as secondary outcomes. It also gathered preliminary data on potential mechanisms of meditation action. After the completion of their 26-week RCT (Period 1), controls were eligible to receive the meditation intervention ("cross-over"), and all participants were followed-up for additional 26 weeks (non-randomized Period 2).

This study will provide evidence about the efficacy of meditation for alcohol relapse prevention, will further our understanding of relapse and the potential mechanisms of meditation action, direct future research and guide clinical decision-making.

Eligibility Criteria:
Inclusion Criteria:

* Alcohol dependence diagnosis
* Completed at least 2 weeks of IOP or (IOP equivalent=at least 2 days per week) for alcohol dependence
* Sober since beginning of outpatient treatment
* English fluency; ability to fill out surveys
* Permanent home address and telephone
* At least 18 years old
* Score \>13 on the Perceived Stress Scale

Exclusion Criteria:

* Pregnant
* Alcohol abstinence \>14 weeks before enrollment
* Current, regular meditation
* Pre-existing bipolar, schizophrenia, or delusional disorder
* Regular drug use (other than tobacco) in last 2 weeks
* Inability to reliably participate
Whether Dexmedetomidine Can Improve the Prognosis of Elderly Patients With Postoperative Cognitive Dysfunction

The purpose of this study is to determine whether postoperative analgesia pump continuous infusion of dexmedetomidine are effective in the prevention of Postoperative delirium and Postoperative cognitive dysfunction.

1. collection of cases: This trail is approved by Hospital Ethics Committee, and patients who participated in the study signed the informed consent. The subject will select 300 elder patients (age ≥60 years) routine tumor surgery, American Society of Anesthesiologists classificationⅠ-Ⅲ. Preoperative liver and kidney function, blood electrolytes were in the normal range.
2. Case group: Selected cases divided into the right dexmedetomidine group and control group by computer randomly, 150 patients in each group. Dexmedetomidine group (A group) analgesia pump formula is: 3 ug/kg sufentanil and 3 ug/kg dexmedetomi-dine, with 0.9% saline diluted to 150ml. Control group (group C) postoperative analgesia formula is: 3 ug/kg sufentanil, with 0.9% saline diluted to 150ml. Two group with the same anesthesia program.
3. Our primary outcome was the 7-day incidence of postoperative delirium assessed by CAM-ICU twice daily (8 a.m. and 8 p.m.) and supplemented with a review of medical and nursing records. The assessment was carried out by investigators who had been trained prior to the trial and were unaware of the group assignment.All investigators and patients were unknown of experiments and results. The four clinical criteria for CAM-ICU are as follows: (1) acute onset with fluctuating course of disease; (2) inattention; (3) altered level of consciousness; (4) disorganized thinking. Delirium can be diagnosed by the appearance of both features 1 and 2, with at least one of features 3 or 4. RASS was used to measure sedation or agita-tion prior to testing delirium. If the patient was deeply sedated or unable to fall asleep (RASS - 4 or - 5), delirium assessment was halted; if RASS score was of - 3 or above, delirium was evaluated by CAM-ICU.

Eligibility Criteria:
Inclusion Criteria:

* Patients' age ≥60 years
* Underwent elective non-cardiac surgery under general anesthesia

Exclusion Criteria:

* Patients with severe bradycardia (heart rate\<55bpm)
* Severe arrhythmia or cardiac dysfunction (ejection fraction\<35%)
* Mini-Mental Scale Test (MMSE) Exclusion criteria: illiteracy \<18, primary school \<21, junior school and above \<25
* Preoperative clear systems and spiritual history of neurological disease or long-term use of sedatives or antidepressants
* History of alcohol abuse or a history of drug dependence
* Have brain surgery or trauma
* Severe vision or hearing impairment
* Cannot with the completion of tests of cognitive function
* Refused to participate in the study
RICE Trial: Rifaximin In Chronic Hepatic Encephalopathy - A Randomized, Controlled Trial

The purpose of this study is to compare the effectiveness of three different treatments for hepatic encephalopathy.


Eligibility Criteria:
Inclusion Criteria:

1. Cirrhosis of any cause
2. History of previous admission for acute HE within 12 months of screening and Conn grade 0-1 HE at time of enrollment
3. An Institutional Review Board (IRB/EC) approved informed consent is signed and dated prior to any study-related activities being initiated.
4. Subject is a male or a non-pregnant and non-lactating female. Women of non-childbearing potential or who are practicing adequate birth control are eligible. The investigator is responsible for determining whether the subject has adequate birth control for study participation.
5. Subject is ≥18 years of age.
6. Subject is capable and willing to comply with all study procedures.
7. If the subject has a history of a portal-systemic shunt, shunt placement or revision must be \>6 months from Screening for TIPS or a surgical shunt.

Exclusion Criteria:

1. Subject has a significant medical or psychiatric condition which, in the opinion of the Investigator, precludes participation in the study.
2. Subject has a history of allergy or intolerance to lactulose.
3. Subject has a history of allergy or intolerance to rifampin or rifaximin.
4. Subject has participated in an investigational drug or device study within the 30 days prior to study screening.
5. Subject is pregnant or is lactating.
6. Subject shows evidence of ongoing alcohol or drug dependence, in the opinion of the Investigator.
7. Subject has a visual impairment disorder (e.g., glaucoma, diabetic retinopathy, or macular degeneration) or a neurological disease beyond HE that, in the opinion of the Investigator, could impact their performance on neuropsychological assessments and psychometric tests.
8. Subject has any condition or circumstance that would, in the opinion of the Investigator, prevent completion of the study or interfere with analysis of study results, including history of noncompliance with treatments or visits.
9. Subject's current, required medications are on prohibited concurrent medication listing.
10. Hemoglobin \< 8.0 at time of screening
11. Severe hypovolemia or electrolyte abnormalities that would be likely to affect mental function (serum sodium less than 120 mEq/L, serum calcium greater than 11 mg/dL) at time of screening
12. Ongoing gastrointestinal bleeding at time of screening
13. Chronic renal insufficiency with a serum creatinine \> 3.0 at time of screening
14. History of tuberculosis infection
MICROPRUNG : Intestinal Microbiota Analysis in Patients With or Without Hirschsprung's Associated EnteroColitis

Hirschsprung disease is a congenital abnormality due to the lack of migration of neural crest cells in myenteric and submucosal plexi of the bowel wall. The consequence is the absence of parasympathetic control of the distal bowel from the anal sphincter to various levels. The most common type of Hirschsprung disease alters the rectosigmoid (80%). The incidence is around 1/5000 live births. This anomaly requires a surgical ablation of the aganglionic segment.

Regardless of the surgical complications, patients with Hirschsprung disease are exposed to the risk of Hirschsprung Associated EnteroColitis (HAEC). This variable risk, 4-54%, is responsible to a major part of Hirschsprung disease morbimortality. Its onset is more frequent during the first two years of life and then decrease with age.

Its pathogenesis remains unclear but could be due to intestinal homeostasis breakdown that involves microbiota, intestinal barrier, immune system and enteric nervous system. This breakdown of the mutual benefit relation due to microbiota or bowel anomaly is known to be responsible of Crohn's disease onset. Some studies emphasize the role of microbiota in the pathogenesis of HAEC, but the techniques or the methodology with small numbers of patients limit any conclusion or clinical use.

The study hypothesizes microbiota is a major factor in HAEC onset and in their functional bowel problems. Considering HAEC is more frequent the first two years, it's thought that intestinal microbiota changes with time in those patients. This project is innovative because it will use high throughput sequencing methods and analysis for microbiome analysis on fecal samples from a multicenter cohort of patients at various ages.

Multicentre transversal study.

This study has the potential to significantly modify clinical practice for Hirschsprung disease patients: a better care for HAEC and functional troubles thanks to a better understanding of their microbiota, targetted antibiotic treatment for HAEC, prophylactic treatment of patients at high risk of HAEC.

Primary objective :

Characterize intestinal microbiota in patients with or without HAEC.

Secondary objectives :

* Look for a difference in microbiota composition between patients with or without HAEC ;
* Study the evolution with age of the microbiota in Hirschsprung disease patients ;
* Study predominant taxonomic classification elements in both groups.

Eligibility Criteria:
Inclusion Criteria:

* Patients from 0 to 16 years ;
* With rectosigmoid Hirschsprung's disease confirmed by rectal biopsies and at surgery;
* Already operated on, whatever the surgical technique was ;
* With a health care insurance;
* Clear information and signed consent form

Exclusion Criteria:

* Long segment Hirschsprung disease ;
* Syndromic Hirschsprung disease ;
* Down syndrome.
Transcranial Magnetic Stimulation in the Rehabilitation of Postoperative Motor Dysfunction.

This study focused on glioma patients with postoperative motor deficits, especially for patients with supplementary motor area syndrome. The investigators want to investigate whether the recovery of motor function will be accelerated by using transcranial magnetic stimulation to stimulate primary motor area and supplementary motor area on the lesional hemisphere.


Eligibility Criteria:
Inclusion Criteria:

1. patient underwent awake craniotomy and motor functional identification during tumor resection;
2. patients with postoperative motor deficit (muscle strength of limbs is weaker than preoperative status)

Exclusion Criteria:

1. patients with contraindication of transcranial magnetic stimulation;
2. patients without data of the pre- and postoperative resting state MRI and diffusion tensor image.
Vitoria Sleep Smart City: Interactive Intervention for Sleep Improvement

Currently, the investigators know that there is a high and increasing prevalence of sleep quality and quantity deficits in the general population with the social and health consequences that this entails. There are numerous activity wristbands linked to mobile apps that analyze sleep, but none can generate individualized recommendations for improvement interacting with the person. The main objective of the current project is to develop a virtual and interactive sleep assistant to increase the quantity and quality of sleep. Secondary objectives being the improvement of daytime sleepiness and the quality of life of the persons.

Methodology: 202 participants in active employment who meet the criteria of "poor sleepers" (defined by a Pittsburg test score \>5) are divided into 2 study groups. 1. Intervention group: Sleep data will be collected using validated questionnaires (SATED and the Sleep Hygiene Index) and objectively employing an activity bracelet, in which weekly, through a live chat, the medical staff of the sleep units will offer recommendations for the improvement of the deficits detected. 2. Control group: Same protocol as the intervention group, but the participants will not receive the recommendations via the interactive chat.


Eligibility Criteria:
Inclusion Criteria:

* Patients aged 18 to 65 years

Exclusion Criteria:

* Patients previously diagnosed and treated for sleep pathology (such as insomnia, Obstructive Sleep Apnea (OSA), Restless Legs Syndrome (RLS), narcolepsy or parasomnia, among others).
* Severe medical or psychiatric comorbidities.
* Subjects who are not capable of using mobile technology such as Smartphone.
* Subjects who are not committed to actively participate, putting into practice the sleep recommendations given by the assistant.
Calcium, Probiotics and Acute Diarrheal Disease Among Indonesian Children

This is a long term study on the efficacy of dietary calcium with or without probiotic strains in reducing the mean number of episodes and duration of diarrheal disease.


Eligibility Criteria:
Inclusion Criteria:

* Apparently healthy children aged 1-6 years, with emphasize on aged 2-5 years, living permanently in low socio-economic urban areas of East Jakarta for at least 6 months
* Parents are willing to sign the informed consent and give the supplements to the children for the period of 6 months
* Capable and willing to drink liquid milk with a straw (acceptance to be tested at screening by providing a sample drink and placebo straw to be consumed under supervision for 2 days)

Exclusion Criteria:

* Calcium intake exceeding 75% of the RDA for calcium (\<375 mg/d) based on a Food Frequency Questionnaire
* Currently breastfed children
* Siblings of already included children that are living in the same household, except if it is a twin sibling
* Severely malnourished with or without oedema (Weight for height-WHZ Z-score of \<-3.00 SD)
* Symptoms of chronic/congenital diseases and disabilities, suspected Tuberculosis by clinical examination, and /or history of allergic disease.
* Taking (any) antibiotics during 2 weeks prior to start of the study (children will be included after 3 weeks of last antibiotic intake
* Participation in another clinical trial at the same time or 2 months prior to the start of this study
* Both mothers and other caregivers present in the family are illiterate
A Trial to Evaluate the Efficacy and Safety of EFLA400 Korea Red Ginseng Extract on Sexual Function in Men With Erectile Dysfunction

Korea red ginseng has been used in maintaining vitality throughout the globally and metabolism and actions on neurologic, cardiovascular, and endocrinologic system are studied. KRG has been used in various ailment, and to prove its efficacy for erectile dysfunction an international study on contries other than Korean was performed. In the present study, subjects with borderline organic and psychogenic erectile dysfunction will be included. KRG will be give daily, and placebo will be give as control. Outcomes including libido, erection, sexual activity, and sexual satisfaction will be measured.

Among the three main lines of therapy for erectile dysfunction (ED), that is, oral therapy, self-injection therapy and penile prosthesis implantation, the first line therapy is always the first option. Despite the successful advent of sildenafil, the first effective oral agent for ED, further development of new drugs and phytochemical studies of widely known herbal plants are desirable. Furthermore, there seems to be a large population that prefers to use phytotherapies rather than pharmaceutical drugs for their health. Korean red ginseng, a phytotherapy plants, used frequently for ED. Ginseng is one of the most popular herbs in both Eastern and Western countries. It is known as a traditional Asian medicine for stimulation of sexual function and studies have shown the effects of ginseng on relaxation of penile corpus cavernous smooth muscle in many studies. In the present study, the investigators will be determined the real role of Korean red ginseng in the treatment of ED.

Eligibility Criteria:
Inclusion Criteria:

* aged 17-70 years
* IIEF(International Index of Erectile Function)-5 scores ≤ 21 subjects.

Exclusion Criteria:

* they had other neurologic or psychiatric disorder
* significant hepatic or renal function impairment (hepatic enzymes \>1.5 times the upper limit of normal and/or serum creatinine \>1.8 mg per 100 ml)
* hypertension (\>170/110 mm Hg), hypotension (\<90/50 mm Hg) or significant cardiovascular disease (unstable angina, coronary artery disease, myocardial infarction or myocardial revascularization).
* Peyronie's disease
Korean Post-marketing Surveillance Ngenla® Pre-filled Pen Injection for the Treatment of Pediatric Patients With Growth Disturbance Due to Insufficient Secretion of Growth Hormone

This non-interventional study will be performed by design of post-marketing surveillance (PMS) as an additional pharmacovigilance activity of the Risk Management Plan (RMP) for Ngenla® pre-filled pen injection, which is required by the Ministry of Food and Drug Safety (MFDS) according to the local regulation. This post-marketing surveillance will investigate the safety and effectiveness of Ngenla® pre-filled pen injection as the treatment of children and adolescents from 3 years of age with growth disturbance due to insufficient secretion of growth hormone during 6 years under the setting of routine practice in Korea.


Eligibility Criteria:
Inclusion Criteria:

- 1. Children and adolescents from 3 years of age with growth disturbance due to insufficient secretion of growth hormone who have received treatment with somotarogon or have been determined to start treatment with somatrogon according to the approved indications of the medicinal product;

2. Evidence of a personally signed and dated informed consent document indicating that the patient or their parent(s)/legal guardian, if applicable, have been informed of all pertinent aspects of the study.

Exclusion Criteria:

1. Patients concurrently participating in other studies involving therapeutic interventions and/or investigational products;
2. Patients who have contraindications to somatrogon as specified in the approved LPD.
3. Patients with hypersensitivity or case history to somatrogon or to any of the excipients in the product