cyrilzakka/clinical-trials huggingface dataset:
Pain Perception in Suicidal Behavior Vulnerability

In France, almost 1 death on 50 is a suicide. The suicide occurs in unbearable psychic pain where mental trouble has a major influence. It is classified as preventable mortality. According to interpersonal psychological theory of suicide, the repeated exposition to stressful and painful events (as physical abuse) would facilitate suicide attempt through the increased pain tolerance. The social pain (or psychical pain on the broader sense) and physical pain are closely linked.

The investigators hypothesize that the measure of painful perception will be significantly superior on suicidals attempters compared to non-attempters. It will be the case for recent suicide attempters and former suicide attempters, suggesting a suicidal vulnerability trait. Moreover, the investigators expect that social distress induced by a social exclusion paradigm will be significantly superior on suicide attempters compared to non-attempters.

The aim of the study is to investigate the physical and psychic pain on depressed subjects with or without history of suicide attempts.

After a clinical evaluation (psychiatric symptomatology, personality trait, suicidal dimension), subjects will be submitted to a painful thermic stimulation and will participate at a computer test of social exclusion (named Cyberball).

242 depressed patients ( 81 recent suicide attempters, 81 former suicide attempters, 80 non-attempters)

First visit : clinical assessment Second visit : pain evaluation and blood sample (from one day to a week maximum after the first visit).

Eligibility Criteria:
Inclusion criteria:

* aged by 18 years old
* came from West Europe, excepted Basque and Sardinian (because of genetics analysis)
* main diagnosis of major depressive episode (DSM V criteria)
* not having take antalgics in the 24 hours before assessment
* received a minimal psychotrope treatment (clinician evaluation)
* Able to understand nature, aims, methodology of the study
* Agree to cooperate in clinical and biological assessment
* Having signed informed consent

Specific inclusion criteria :

81 recent suicide attempters (being hospitalised for suicidal attempts and having realised a suicide attempts 8 days before inclusion) 81 former suicide attempters (having realised in his lifetime a suicide attempt, one month before inclusion)

Exclusion criteria:

* Current diagnosis of manic, hypomanic or alcohol dependance or substance abuse in the last 6 months, or diagnosis of schizophrenia or schizoaffective disorder in his lifetime
* Current algic and chronic neurologic disease
* Current or actual treatment by tricyclic antidepressant and Serotonin and norepinephrine reuptake inhibitors(SNRIs)
* Pregnancy
* Patients on protective measure
Costs, Efficiency and the Role of Management in HIV Prevention Interventions for Female Sex Workers in Nigeria

This study seeks to measure the costs associated with HIV prevention service delivery to female sex workers (FSW) in Nigeria, as well as examine the relationship between management practices at the community-based organizations (CBOs) and costs. To complete these goals, the study will collect both retrospective and prospective data from CBOs and from centralized information from study partners (Society for Family Health, SFH). In the prospective section of the study, CBOs will be sampled and assigned to either treatment or control groups. Data collected at the CBOs will be aggregated by the CBO managers, and those in the treatment group will receive feedback on their performance on a monthly basis. Those in the treatment group will additionally receive a management training to guide their management practices. Researchers hypothesize that there will be improvements in management indicators and therefore decreases in costs at CBOs in the treatment group. Results will be disseminated to local, national, and international stakeholders.


Eligibility Criteria:
Inclusion Criteria:

* Clusters: community-based organizations that serve female sex workers under Society for Family Health, through the SHIPs or Global Fund grants
* Participants: managers ("officers") that oversee the functions of the organization and supervise volunteer staff

Exclusion Criteria:

* Clusters: excludes organizations not serving female sex workers and not working under Society for Family Health, through Global Fund or SHIPs grants
* Participants: excludes anyone not explicitly working as a manager overseeing volunteer implementation
Comparative Study of Rohto Dry-Aid® and Systane® Ultra in Patients With Dry Eye

The objective of this study is to evaluate the efficacy of Rohto Dry-Aid® in comparison to Systane® Ultra on visual function and tear film stability in patients diagnosed with Dry Eye.


Eligibility Criteria:
Inclusion Criteria:

* Be at least 18 years of age
* Provide written informed consent
* Have a reported history of dry eye
* Have a history of use of eye drops for dry eye symptoms
* Ocular discomfort
* Conjunctival redness
* Tear film break up time
* Corneal and Conjunctival Staining

Exclusion Criteria:

* Have any clinically significant slit lamp findings at entry visit
* Be diagnosed with an ongoing ocular infection
* Have any planned ocular and/or lid surgeries over the study period
* Have an uncontrolled systemic disease
* Be a woman who is pregnant, nursing or planning a pregnancy
* Be a woman of childbearing potential who is not using an acceptable means of birth control
* Have a known allergy and/or sensitivity to the test article or its components
* Have a condition or be in a situation which the investigator feels may put the subject at significant risk, may confound the study results, or may interfere significantly with the subject's participation in the study
Impact of Chronic Cough on Activities of Daily Living and Response to Acute High-intensity Exercise

Chronic cough is a common and debilitating condition that affects up to 10% of the global population. The health impact of chronic cough is multifaceted and manifests both physical and psychological symptoms including syncope, chest pain, lethargy, depression and anxiety. It is now also recognised that chronic cough often leads to social isolation and may impact an individual's ability or confidence to undertake routine daily tasks / lead an active lifestyle.

The primary aim of this study is therefore to characterise the impact of unexplained chronic cough on the ability to undertake daily activities - i.e., determine whether individuals with chronic cough exhibit impaired levels of physical activity during usual daily living when compared with healthy age, gender and BMI matched controls. A secondary aim is to assess the short-term impact of high-intensity exercise on cough (i.e., determine whether an acute bout of exercise alters cough frequency and/or severity).


Eligibility Criteria:
Inclusion Criteria:

* Age \>18 years
* Chronic cough as per European Respiratory Society definition (\>8 weeks duration)
* High symptom burden (i.e., cough visual analogue scale \>40 mm at pre-study screening)
* Chest radiograph or CT within 3 years of the screening visit with no abnormalities considered to contribute to chronic cough

Exclusion Criteria:

* Smokers or individuals who gave up smoking within 12 months
* Smoking history \>20 pack-years
* Long-COVID or post-COVID syndrome (defined as symptoms lasting over 12-weeks in duration)
* Recent exacerbation of cough within 4 weeks of inclusion
* Respiratory tract infection within 4 weeks of inclusion
* Currently taking any of the following medications:

  * ACE inhibitors and within 3 months of inclusion
  * Antitussives (opioids, pregabalin, gabapentin, amitriptyline, nortriptyline, or over the-counter medications) within 2 weeks of inclusion
  * Medical treatments for gastro-oesophageal reflux disease (GORD), eosinophilic bronchitis or other cough related conditions, initiated or changed (i.e., not in a stable regimen) for 4 weeks prior to inclusion
* Medical history of asthma or exercise-induced bronchoconstriction (EIB), COPD, or chronic bronchitis in the judgement of the investigator
* Medical conditions/history or other circumstances which, in the judgement of the investigators, could increase the risk of adverse events or bias the study results
Comparing Bubble and Ventilator Nasal CPAP in Preterm Infants

There are various methods to generate the pressure needed for Nasal CPAP. Some neonatal intensive care units (NICU) use an underwater bubbling system and others use a ventilator to generate the pressure. There is no right or wrong way to generate the pressure and both methods are approved and accepted.

The aim of this study is to compare the two systems of Nasal CPAP by placing the baby on each for a defined time period and reviewing the infant's vital signs. The investigators expect that the pressure generated by bubble CPAP will be better and lead to improved vital signs.

There are various methods to generate the pressure needed for Nasal CPAP. Some neonatal intensive care units (NICU) use an underwater bubbling system and others use a ventilator to generate the pressure. There is no right or wrong way to generate the pressure and both methods are approved and accepted.

The aim of this study is to compare the two systems of Nasal CPAP by placing the baby on each for a defined time period and reviewing the infant's vital signs. The investigators expect that the pressure generated by bubble CPAP will be better and lead to improved vital signs.

Eligibility Criteria:
Inclusion Criteria:

* Neonates between 26-32 weeks gestational age who have been on Nasal CPAP for at least 48hrs on fraction of inspired oxygen (FiO2) of \< or = 0.3. Parental consent will be obtained prior to enrollment.

Exclusion Criteria:

* Infants with severe congenital anomalies, such as airway or chest wall deformities, pulmonary hypoplasia, congenital heart disease, neurologic abnormalities including severe intraventricular hemorrhage (IVH) and need for surgery eg. for necrotizing enterocolitis will be excluded from the study. Any infants with genetic/chromosomal abnormalities will be excluded.
A Pilot Study on Effect of SKY on Psychosocial Parameters of Type 2 Diabetic Patients After a 6 Days

The purpose of this study is to determine whether Sudarshan Kriya Yoga intervention has effect on the quality of life , anxiety and depression of Type 2 Diabetic Patients.

Diabetes is a psychologically and behaviorally demanding disease; therefore psychosocial factors are relevant to nearly all aspects of its management. Research findings have demonstrated that depression is more common in patients with diabetes than in the general population, at least 15 % of patients have clinical depression.Yoga is a mind-body alternative therapy which can be used to prevent and treat type 2 diabetes mellitus and related complications.

Sudarshan kriya Yoga is a unique yogic breathing practices which involves several types of cyclical breathing patterns, ranging from slow and calming to rapid and stimulating. It is recommended for relaxation, stress management, control of psycho physiological states and to improve organ function. In this pilot study Investigator recruited 24 type 2 diabetic patient and those who consent were provided with 6 days yoga course for a duration of 3 hours and trained to practice SKY at home for 12 week. At baseline and after 6 days of SKY, questionnaire on anxiety, depression and quality of life were provided to them. Biochemical parameters were measured at baseline and after 12 weeks of yoga. Two follow up yoga session were provided to the participants. Primary outcome were pre to post intervention change in the mental health and quality of life.

Eligibility Criteria:
Inclusion criteria

1. Patients showing stress as per the stress indicators.
2. Patients of both gender of age 30 to 65 years on oral anti diabetic agents
3. Patient is able to perform yoga postures and breathing exercise.
4. Patient is able to consent for the study.
5. Patient should be able to understand English as that is the medium used.

Exclusion criteria

1. Bipolar disorder
2. Antidepressant drugs
3. Type 1 diabetes
4. Pregnancy
5. Any acute coronary symptoms in past 6 months
6. Artificial pace-maker
7. Previous (SKY) or any type of spiritual meditation practiced within 6 months
Hyperthermia With Flexible Electrode-typed 2-MHz Device During Radiotherapy for Solid Tumors

The main purpose of this study is to evaluate immunogenic effect of hyperthermia applied with flexible electrode-typed 2-MHz device during radiotherapy for solid tumors.


Eligibility Criteria:
Inclusion Criteria:

* Solid tumor (primary, metastatic)
* Eastern Cooperative Oncology Group (ECOG) score 0-3
* Ability to understand and the willingness to sign a written informed consent documents

Exclusion Criteria:

* Myocardial infarct, unstable angina, heart failure, uncontrolled arrhythmia within 6 months
* Active infectious disease
* Pregnant or probability of pregnancy during treatment
* Obesity (BMI ≥35)
* Immunosuppressive drug after organ transplantation
* Autoimmune disease
* Skin injury on treatment area
Reduction of Adverse Pregnancy Outcomes With a Smartphone Application in Ghana

The purpose of this study is to determine whether use of the Safe Delivery smartphone application by midwives can reduce excess blood loss from bleeding, and infant death during childbirth in Ghanaian women. Moreover, it will be investigated whether the Safe Delivery application can increase midwives' knowledge and skills in managing childbirth.

Fifteen hospitals in Greater Accra, Ghana, will be cluster randomized to either use the Safe Delivery application (intervention), or to no intervention (control). In the intervention hospitals, midwives will be educated in the use of Safe Delivery. Pregnant women will be enrolled at delivery and followed until 7 days postpartum. Data collection will begin July 2014 and is expected to be finished by October 2014.


Eligibility Criteria:
Inclusion criteria for Hospitals:

* Located in the region of Greater Accra.
* The hospital should have at least 10 midwives employed.
* The patient flow for each midwife should be at least 10 deliveries per month.
* The annual average number of deliveries should be at least 1,200.

Inclusion criteria for midwives:

* Should have no leave or vacation from June 17th to September 17th 2014.
* Should have a full time employment at the delivery ward (conducting deliveries 100% of the work time).
* Should be willing and available to participate in an information meeting at the hospital where the balloting among eligible midwives will take place.
* Should give an informed consent to participate in the study.
* Should be willing and available to participate in a workshop July 14th 2014 (this is the day of randomization, and intervention midwives will receive smartphone training).
* Should be willing and available to participate in a workshop September 17th 2014 (to complete an end of study questionnaire, the key feature questionnaire, and control midwives will receive smartphones).
* Should be proficient in English to understand the spoken instructions in the animated videos.

Inclusion criteria for women in labor:

* Should be in active labor.
* Should give informed consent to participate in the study.
* Should give birth vaginally.

The women in labor and their newborn children will be the primary observational units.
To Study Gene Expression of Postburn Hypertrophic Scar

Aim: To compare the gene expression of postburn hypertrophic scar with normal skin.

Background: Postburn hypertrophic scar (HS) remains a challenging problem. Although varied clinical therapeutic methods have been used, none of them has been widely accepted as a standard care. As hypertrophic scar is hereditary, gene therapy can be a potential tool for scar treatment. To investigate the correlation between the clinical presentation of the hypertrophic scar and its gene expression, we propose an analysis of gene expression in the hypertrophic scar using DNA microarray and Real-Time Quantitative PCR. The study result may form the base of clinical treatment.

Methods and Materials: Thirty scar patients requiring surgical treatment in NTUH burn center will be enrolled into the study. Inclusion criteria: (1) Age between 20 and 80 (2) Patients with postburn hypertrophic scar require surgical treatment.

1. Hypertrophic scar and normal skin collection: Under Clinical Trial Informed Consent of Research Ethic Committee, scar and normal skin specimen of 1x1cm2 each will be collected and transported to tissue bank with a vacuum low temperature container. The specimen will be kept in a -80℃ refrigerator.
2. RNA extraction from skin tissue: The RNA extraction will be performed using kit available in the market. Spectrophotometer and gel electrophoresis will be used to measure the purity and concentration of RNA.
3. Gene expression analysis: DNA microarray and Real-Time Quantitative PCR will be used to analyze RNA expression of hypertrophic scar and normal skin.

Statistics: Student's t-test will be used to compare statistically gene expression between hypertrophic scar and normal skin. P \< 0.05 will be considered as statistical significance.

Eligibility Criteria:
Inclusion Criteria:

* age20\~80, hypertrophic scar patient

Exclusion Criteria:

* no specific limitation
POLY-unsaturated Fatty Acids in the Preservation of Dietary Effects on Hepatosteatosis and Energy Metabolism in Type 2 Diabetes

Basic treatment of type 2 diabetes should focus on diet, physical activity and lifestyle. Nevertheless, in early and late stage of T2DM, lifestyle intervention is mostly substituted by pharmacological intervention, although lifestyle modification and dietary treatment would be favourable.

The researchers therefore investigate dietary strategies such as low-carb and very-low calory diets regarding their potential to improve metabolism and body weight in (mostly) long-term T2DM patients. This core comparison is dealt with in the DiNA-D study (published elsewhere).

POLYPHEM targets specific dietary approach to preserve the achieved metabolic improvements from DiNA-D phase 1. Nutritional factors will be PUFAs and BCAAs.

Basic treatment of type 2 diabetes should focus on diet, physical activity and lifestyle. Nevertheless, in early and late stage of T2DM, lifestyle intervention is mostly substituted by pharmacological intervention, although lifestyle modification and dietary treatment would be favourable.

The researchers therefore investigate dietary strategies such as low-carb and very-low calory diets regarding their potential to improve metabolism and body weight in (mostly) long-term T2DM patients. This core comparison is dealt with in the DiNA-D study (published elsewhere).

POLYPHEM targets specific dietary approach to preserve the achieved metabolic improvements from DiNA-D phase 1. Nutritional factors for the maintenance period within DiNA-D (11 months) will be PUFAs and BCAAs, provided by walnuts and custom-made muffins containing walnuts, sunflower oil and isomaltulose.

Eligibility Criteria:
Inclusion Criteria:

* male and female subjects
* 18-79 years old
* type 2 diabetes

Exclusion Criteria:

* renal insufficiency
* anaemia
* immunosuppression
* previous symptomatic cancer diagnosis
* acute cardiovascular disease (stroke, coronary syndrome)
* pregnancy and lactation
* severe psychiatric disorders
* corticoid or other immunosuppressive therapy
Evaluation of Nexpowder Application to Prevent Delayed Bleeding After Colorectal Endoscopic Mucosal Resection

Delayed bleeding is the most frequent (5 to 15%) and challenging complication after large colorectal polypectomy. Different preventive treatments, such as the prophylactic use of clips, have been tried to prevent the occurrence of delayed bleeding, but to date, no treatment has clearly shown its effectiveness. In addition, preventive hemostasis with clips is difficult and costly. A newly developed endoscopic hemostatic powder generating gelation effect (Nexpowder) may be an effective alternative to prevent post polypectomy bleeding in patients treated by endoscopic mucosal resection (EMR) for large superficial colorectal lesions.


Eligibility Criteria:
Inclusion Criteria:

* More than 18 years old
* Indication of EMR for a superficial nonpedunculated colorectal lesion
* Higher risk of bleeding (score GSEED RE2 ≥ 7\*)

  \*Score GSEED RE2 (Albeniz et al GIE 2020):
* Proximal location (cecum to transverse included) : 3 points
* Antiplatelets or anticoagulation use: 3 points
* Lesion size ≥ 40 mm: 1 point
* ASA III-IV or major comorbidity: 1 point

Exclusion Criteria:

* Patients susceptible to allergic reactions to certain substances in Nexpowder
* More than one colorectal lesion
* Suspicion of invasive cancer (Kudo V, Sano IIIb, Connect III), macronodular more than 1 cm, depressed area (Paris IIc)
* Pedunculated polyps (Ip from Paris classification) or ulcerated polyps (III)
* Recurrent or residual lesion after endoscopic or surgical resection
* Poor bowel preparation quality (Boston score \< 6)
* Inflammatory bowel disease (IBD)
* Patients with a platelet count of 50,000/mm3 or less
* Patients with acquired (non-medicated) or inherited bleeding disorders
* Patients with advanced cancer or inflammatory bowel disease, including ulcerative colitis (with colonic involvement)
* Contraindication to general anesthesia
* Women who are pregnant or who wish to become pregnant during the study or women who are breastfeeding.
* Children, immunocompromised persons and persons over 90 years of age
* Patients already participating or scheduled to participate in other clinical trials
* Lesion previously resected by endoscopy
* Patient with an initial metastatic lesion before colonoscopy
* Patient unable to give personal consent
* Lack of signed informed consent
Peak Systolic Global Longitudinal Strain and Low Cardiac Output Syndrome After Cardiac Surgery

This is a retrospective observational study to assess the relationship between peak systolic global longitudinal strain measured on pre-cardiopulmonary bypass trans-esophageal echo images predicts post-operative low cardiac output syndrome defined as the need for an inotropic support during 24 hours or longer.


Eligibility Criteria:
Inclusion Criteria:

* Cardiac surgery involving the use of cardiopulmonary bypass
* Availability of pre-cardiopulmonary bypass trans-oesophageal echo images allowing measurement of the peak systolic global longitudinal strain

Exclusion Criteria:

* Preoperative atrial fibrillation
* Preoperative critical state
* Emergent/salvage surgery
* Heart transplant surgery
* Left ventricular assist device implantation