cyrilzakka/clinical-trials huggingface dataset:
Abdominal Pain Disorders Functional in Children: Impact of Hypno-analgesia on the Autonomic Balance

Abdominal pain disorders functional (including functional dyspepsia, irritable bowel syndrome, abdominal migraine, functional abdominal pain) is a very common disease in the pediatric population, where classical medical treatment does not always prove effective. This clinical entity has an impact on the individual physiological balance particularly on the autonomic regulation. Studies concerning adults with irritable bowel syndrome, showed significant changes in heart rate variability indices (HRV: heart rate variability).

The study of time and frequency domain analysis of HRV allows noninvasive and reproducible assessment of the cardiac sympathetic and parasympathetic tone.

The investigators hypothesize that the sympathovagal balance could be altered in children in case of prolonged nociceptive stress as the investigators find it especially in irritable bowel syndrome and functional abdominal pain. In recent years, the control of pediatric pain experienced considerable growth through hypnosis techniques and several studies have shown analgesic efficacy with a beneficial effect in terms of quality of life in children.

Our study aims to assess the impact of the hypno-analgesia treatment of Abdominal pain disorders functional on sympathovagal balance. The investigators propose to realize in 7 to 18 years old children with Abdominal pain disorders functional a single center prospective study to highlight after a standardized hypnosis program, changes in the time and frequency domain indices of heart rate variability and clinical or quality of life parameters. The primary endpoint will be the high frequency HF indice. Secondary endpoints will be the other indices of HRV (Ptot, VLF, LF, ratio LF / HF, SDNN, SDANN, pNN50, RMSSD), the Quality of Life Questionnaire values (PedsQL ™ 4.0) a pain scale and the composite score of Francis.


Eligibility Criteria:
Inclusion Criteria:

* Parents affiliates or entitled to a social security scheme
* Consent form signed by the holder of parental authority

Exclusion Criteria:

* Child with pathologies reaching the central nervous system or the brain stem.
* Children with a severe pathology of cardio-respiratory or heart being referred to treatment.
* Children requiring emergency surgery or trauma or septic or inflammatory context.
* Children with psychiatric disorders or mental retardation proven.
* Children who have already used the earlier hypnosis.
* Children not speaking French language.
Efficacy of Five Strategies To Improve Stroke Awareness in the Spanish-Speaking Population

The goal of this experimental study is to evaluate the efficacy of five educational strategies for recognizing early symptoms of cerebrovascular disease (CVD) in the general adult population. The main questions it aims to answer are:

- How effective are the strategies RAPIDO, CORRE, DALE, CAMALEON, and ICTUS 911 in improving the recognition of early CVD symptoms?

Researchers will compare these strategies to determine which one leads to the highest increase in symptom recognition. Participants will receive a brief educational session on one of the five strategies and will:

* Complete a pre- and post-intervention survey (Stroke Awareness Questionnaire, SAQ).
* Receive short training on CVD symptoms and the urgency of contacting emergency services.

The primary outcome is the improvement in SAQ scores, and the secondary outcome is the proportion of participants achieving adequate knowledge of CVD symptoms.


Eligibility Criteria:
Inclusion Criteria:

* Age: Participants must be 18 years or older.
* Consent: Participants must provide informed consent to participate in the study.
* General Population: Participants from the general public, regardless of their health insurance status or previous medical history (except as specified in exclusion criteria).
* Language: Participants must be fluent in Spanish, as the educational interventions are based on Spanish-language mnemonic strategies.

Exclusion Criteria:

* History of Stroke: Participants with a previous diagnosis of cerebrovascular disease (stroke) will be excluded.
* Cognitive Impairment: Participants who are unable to understand or complete the Stroke Awareness Questionnaire (SAQ) due to cognitive or communication impairments will not be eligible.
* Incomplete Evaluation: Participants who are unable to complete both the pre- and post-intervention assessments will be excluded from the study.

Elimination Criteria:

* Lack of Follow-Up: Participants who fail to attend the second evaluation (7 days post-intervention) will be excluded from the final analysis.
* Withdrawal of Consent: Participants who choose to withdraw from the study at any time will be eliminated from further participation.
Vitreous Detachment and Glaucoma Progression

Posterior vitreous detachment is a common event. With optical coherence tomography, the investigators can precisely follow the stage of posterior vitrous detachment. In this study, the investigators investigate if the loss of contact between the vitreous and the fovea is the start of glaucoma progression.


Eligibility Criteria:
Inclusion criteria:

* Patient with glaucoma
* at least 4 years of follow up
* at least 6 visual fields
* at least 4 optical coherence tomographies

Exclusion criteria:

* pars plana vitrectomy
* others ophtalmological or neurological disease which can modify visual fields
Prevention of Post-Traumatic Stress Disorder in Soldiers

Soldiers in conflict or former conflict regions deployed in peace-keeping missions were and are often exposed to multiple traumatic events and situations in which they are forced to engage in violent behavior. The Preventive Narrative Exposure Therapy (Pre-NET) aims to reinforce resilience thereby reducing the risk of developing or aggravating PTSD or other mental disorders as a result of traumatic experiences. The effective prevention of mental disorders as a result of war deployment is expected to facilitate reintegration in civil life after deployment and reduce uncontrolled violence.


Eligibility Criteria:
Inclusion Criteria:

* Exposure to traumatic experiences derived from expert interviews with scores of the Traumatic Life Event List for War and Torture
* Soldiers are part of the Burundian army and of the joint African Union and United Nations peacekeeping mission in Somalia (AMISOM)

Exclusion Criteria:

* Current use of mind altering drugs
* Psychotic symptoms
The Effect of Self-regulatory Education on Women With Asthma

The project evaluates an innovative educational intervention using telephone counseling based on self-regulation theory designed to address a problem heretofore overlooked in asthma self-management education: the unique needs of adult female patients.

BACKGROUND:

More than half of the adults with asthma in the US are female. Prevalence of asthma in women appears to be increasing, and morbidity and mortality rates for this group are significantly higher than rates for men. Recent studies point to unique features in women's management of asthma potentially attributable to gender. These include, for example, factors associated with hormonal cycles, (e.g. menses, pregnancy, menopause) and social roles (e.g. household tasks exposing one to environmental triggers, caregiving to children and relatives interfering with asthma management etc.) To date, no rigorously evaluated intervention expressly designed for women with asthma has been reported in the literature.

DESIGN NARRATIVE:

This study is to assess the effectiveness of a gender-specific telephone counseling, self-regulation intervention for women with asthma. To test our hypothesis we employed a randomized controlled design utilizing an intervention group and a control group. The primary outcomes are gender-related asthma management problems, health care utilization, days having symptoms, self-regulation level, management skill, and quality of life. We measure at three time points: baseline before randomization; follow-up I, one year subsequent to randomization; and follow-up II, one year subsequent to follow-up.

Eligibility Criteria:
The study participants are a noninstitutionalized ambulatory sample of women who are willing to participate in the project and meet the following criteria:

1. 18 years of age or older,
2. a diagnosis of asthma,
3. presence of active symptoms,
4. enrolled as a patient in one of the University of Michigan Medical Center asthma-related clinics,
5. listed as having received face-to-face instructions by clinic personnel on peak flow monitoring and proper use of medicine and delivery devices, and
6. not pregnant.

Women who are found to have extenuating circumstances that would prevent them from fully benefiting from the program (e.g., mental illness or terminal illness) are excluded.
A Trial Comparing Treatment With Tiotropium Inhalation Capsules to Combivent Inhalation Aerosol in COPD Patients.

The objective of this study is to evaluate the efficacy and safety of 12 weeks treatment with tiotropium HandiHaler 18 micrograms (mcg) daily compared to Combivent Metered Dose Inhaler (MDI) Chlorofluorocarbon Inhalation Aerosol 2 actuations four times a day in Chronic Obstructive Pulmonary Disease (COPD) patients currently prescribed Combivent® MDI.


Eligibility Criteria:
Inclusion Criteria: Diagnosis of Chronic Obstructive Pulmonary Disease (COPD) Age: greater than or equal to 40 years

* Current or ex-smoker with a \>= 10 pack-year smoking history
* Use of Combivent® Metered Dose Inhaler (MDI)for \>= 1 month prior to Visit 1

Spirometric criteria (determined at study visits):

* Post-bronchodilator Forced Expiratory Volume in one second (FEV1) \<= 70% (Visit 1)
* Pre-bronchodilator FEV1 \<= 65% of predicted and FEV1/Forced Vital Capacity (FVC) \<= 70% (Visit 2)

Exclusion Criteria:

Clinical history of asthma

* History of thoracotomy with pulmonary resection
* History of Cystic Fibrosis, alpha 1 antitrypsin deficiency or interstitial lung disease
* Daytime use of oxygen therapy for \> 1 hour per day or if unable to abstain fr om using oxygen during Pulmonary Function Tests
* Any respiratory tract infection or COPD exacerbation in 6 weeks prior to Visit 1
* Recent history 6 months or less of Myocardial Infarction
* Unstable or life-threatening cardiac arrhythmias
* Hospitalization for Congestive Heart Failure during past year
* Malignancy for which patient is receiving chemo or radiation therapy
* Pregnant or nursing women
* Known hypersensitivity to ipratropium or carrier substances, including related food products such as soybean, peanuts, or lactose
* Use of SPIRIVA® 3 months prior to Visit 1
* Symptomatic of prostatic hypertrophy or bladder neck obstruction
* Known narrow- angle glaucoma
* Participating in a pulmonary rehab program within 4 weeks of Visit 1
Clinical Routine in Thoracic Outlet Syndrome

Transversal recording and analysis of investigations performed in patients referred for suspected thoracic outlet syndrome (TOS)

Patients will have recording on a database of all investigations that were eventually performed for the diagnosis or follow up of their disease, among which:

* Characteristics (Age, Gender height, weight, ongoing treatment ,
* professional activity, sports activity,
* Symptoms.
* Forearm and finger photoplethysmography (PPG) during provocative maneuvers of the upper limb
* Transcutaneous oxymetry (Tcpo2) recording
* Standard questionnaires (MASC, DASH, FS36)
* Doppler and ultrasound during provocative maneuvers of the upper limb
* Angiography during provocative maneuvers of the upper limb
* Electromyogram
* Standard X-ray

Eligibility Criteria:
Inclusion Criteria:

* Absence of deny for the use of medical filesfor research purposes

Exclusion Criteria:

* Inability to understand the purpose of the database.
* Patient protected by law.
Long-Term Follow-Up Gene Therapy Study for Achromatopsia CNGB3 and CNGA3

This study is a longer-term follow-up study for patients who participated in one of the clinical trials: AAV - CNGB3 retinal gene therapy for patients with achromatopsia, or AAV - CNGA3 retinal gene therapy for patients with achromatopsia.

The follow up study is designed to collect data on longer-term safety and efficacy.

Eligibility Criteria:
Inclusion in the study will be limited to individuals who:

1. Are able to give informed consent or assent, with or without the guidance of their parent(s)/guardian(s) where appropriate
2. Received AAV2/8-hCARp.hCNGB3 or AAV2/8-hG1.7p.coCNGA3 by intraocular administration in the prior open-label, Phase I/II, dose escalation study (EudraCT 2016-002290-35 or EudraCT 2018-003431-29)
3. Are willing to adhere to the protocol and long-term follow-up

Individuals will be excluded who:

Are unwilling or unable to meet with the requirements of the study
PDR001 in Combination With Bevacizumab and mFOLFOX6 as First Line Therapy in Patients With Metastatic MSS Colorectal Cancer

This was a phase Ib study of PDR001 in combination with bevacizumab and mFOLFOX6 as first line therapy in patients with metastatic microsatellite stable (MSS) colorectal cancer. The study was to have assessed primarily, the safety and tolerability and then the efficacy of PDR001 in combination with bevacizumab and mFOLFOX6. Particular attention would have been paid to the level of activity of study drug combinations in CMS4 patients (retrospective analysis).

The study was terminated early due to company decision.


Eligibility Criteria:
Key inclusion criteria:

1. Patients with metastatic MSS colorectal adenocarcinoma.Note: MSI status will be performed locally by an immunohistochemistry (IHC) or PCR based test for eligibility.
2. Patients must provide a newly obtained or an archival tumor sample corresponding to CRC diagnosis (primary tumor) with sufficient tissue quality (qualified) for analysis (mandatory)
3. Patients must provide a newly obtained tumor tissue sample from a metastatic site (mandatory)
4. Patients who are naïve to systemic treatment in metastatic setting. Patients with previous neoadjuvant or adjuvant chemotherapy (that may have included oxaliplatin or investigational VEGF inhibitors) are eligible if the treatment was completed \> 12 months before inclusion.
5. Patients with the presence of at least one lesion with measurable disease as per RECIST 1.1 guidelines. Lesions in previously irradiated areas should not be considered measurable unless they have clearly progressed since the radiotherapy.

9. Patients have an Eastern Cooperative Oncology Group (ECOG) performance status 0-1

Key exclusion criteria:

1. Patients with MSI-H colorectal adenocarcinoma as defined per local assessment using standard of care testing
2. Patients with metastatic disease amenable to be resected with potentially curative surgery
3. Patients who have received any systemic treatment for metastatic disease.
4. Patients with a history of prior treatment with anti-PD-1, anti-PD-L1, anti-PDL2, anti-CTLA-4 antibodies, other checkpoint inhibitors
5. Patients who had received radiation within 14 days prior to the first dose of study drug

Other protocol-defined inclusion/exclusion criteria may apply
Carbohydrates Distribution in Pregnancy Study

Hypothesis: Patients with Gestational Diabetes Mellitus (GDM) have a high risk to develop complications during pregnancy, puerperium and in the newborn. At present there are not scientific evidences about the optimal distribution of meals in the medical nutrition therapy (MNT) and their relationship with glycemic control.

Aim: To explore and compare ketonemia and glycemic profile in patients with GDM that follow a MNT distributed in 6 or 3 meals. Besides, we want to explore the differences between both treatments in glucose dynamics.

Methods: The study design is a randomized, crossover and multicentric trial. A sample of 10 patients with GDM will be recruited in the Department of Endocrinology and Nutrition from both centres. In a randomized manner patients will follow the conventional treatment (a carbohydrate-controlled diet distributed in 6 meals: 3 main meals and 3 snacks) and the intervention treatment (a carbohydrate-controlled diet distributed in 3 meals: breakfast, lunch and dinner). They will be randomized to begin with one of the two treatments, and after two weeks they will be switched to the other treatment. Patients will wear a blinded continuous glucose monitoring device (iPro2-TM, Medtronic) during the entire study period.

Inclusion criteria:

* Women with GDM diagnosed in 24-28 weeks.
* Age 18-40 years.
* Pregnancy age of 28-32 weeks.
* Caucasian.
* Body mass index ≤ 35 Kg/m2.

Exclusion criteria:

* Unability to understand the dietary recommendations and/or to perform self-management of glycemia, ketonuria or ketonemia.
* A low adherence to MNT.
* Problems with written and/or oral communication.
* Presence of comorbidities other than obesity, hypertension and dyslipidemia.
* Insulin-need criteria within 3 first days of the beginning of the study (fasting glucose ≥90mg/dL, postprandial glucose 1-hour ≥140mg/dL).

Clinical and sociodemographic variables will be assessed. Dietary records and blood samples will be collected. Daily basal ketonuria and ketonemia before each meal will be assessed. Glycemic profile will be collected with a blind-sensor during the four weeks of the intervention study. Generalized linear model analysis will be performed. Statistical power will be 80% and significance level will be set at 0.05. Written informed consent will be collected from all participants.


Eligibility Criteria:
Inclusion Criteria:

* Women with GDM diagnosed in 24-28 weeks.
* Age 18-40 years.
* Pregnancy age of 28-32 weeks.
* Caucasian.
* Body mass index ≤ 35Kg/m2.
* Firs-time mother.

Exclusion Criteria:

* Disability to understand the dietary recommendations and/or to perform self-management of glycemia, ketonuria or ketonemia.
* A low adherence to MNT.
* Problems with write and oral communication.
* Other comorbidities differed of obesity, hypertension and dyslipidemia.
* Insulin criteria within 3 first days of study (fasting glucose ≥90mg/dL, postprandial glucose 1-hour ≥140mg/dL).
Digital Cognitive Behavioral Therapy for Insomnia for Chronic Insomnia in Breast Cancer Survivors

To explore the efficacy of dCBT-I therapy for chronic insomnia among breast cancer survivors in China, we propose to conduct a randomized, parallel controlled clinical study in breast cancer survivors using a smartphone Chinese application (app) "resleep". Breast cancer survivors with chronic insomnia were recruited from our Breast Disease Center and externally, with the waiting group as a parallel control and the dCBT-I treatment group as an intervention group, in a 1:1 sample size. Intervention group (dCBT-I treatment group) will receive full self-help dCBT-I administered by smartphone APP for 6 weeks. The control group (waiting for treatment group) will not receive any additional interventions based on the original conventional treatment and will be followed up as planned, waiting for treatment.At the end of the 3-month follow-up, the decision to receive treatment was made according to the patient's wishes. The primary endpoint was the insomnia severity index (ISI) at the end of treatment and at 3 months of treatment.


Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 18 years.
2. Breast cancer diagnosed within 5 years
3. Stable disease at the end of acute treatment (surgery, radiotherapy, chemotherapy) while meeting: ≥ 1 month after surgery, ≥ 3 months after the end of last chemotherapy, and ≥ 3 months after the end of last radiotherapy if radiotherapy is required.
4. Satisfy the diagnostic criteria for chronic insomnia disorder according to the (International Classification of Sleep Disorders-the Third Edition, ICSD-3)\[ and Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5): problem with falling asleep or maintaining sleep for ≥3 months (≥3 times per week) with impaired daytime functioning, despite the availability of sleep opportunities.
5. ISI score ≥12.
6. Other sleep or psychiatric disorders, if present, must be stable and require no medication.
7. Be proficient in the use of a cell phone application, and be comfortable reading, filling out the electronic questionnaire, communicating, and fully understanding the content.
8. Sign the informed consent form. -

Exclusion Criteria:

1. New breast cancer progression, recurrence, or metastasis within 3 months, requiring new radiotherapy or immunotherapy regimen
2. Expected survival \<12 months due to all causes
3. Presence of any of the following conditions: Concurrent active cancer or malignancy that is being treated other than breast cancer, shift work, alcohol abuse, substance abuse, significant suicidal ideation, bipolar disorder, aggressive behavior, mania, schizophrenia.
4. Presence of a diagnosed significant physical illness that interferes with sleep, such as cranial disease or trauma, cancer pain, unstable angina, uncontrolled cardiac insufficiency and severe respiratory distress due to various causes, etc.
5. Current or previous treatment with cognitive behavior therapy for insomnia (CBT-I).
6. Not signed informed consent.
Development of a Multi-sensory Rehabilitation Program for People With Ultra Low Vision

This research is aimed to address one of the big gaps in the current vision rehabilitation protocols for people with profound visual impairment by evaluating a multisensory approach. There are a growing number of clinical trials that recruit people with end-stage eye diseases and the rehabilitation plan following various treatments is not clear. It is important to address this in order to maximize the efficacy of such treatments and to improve the quality of life in people with profound visual impairment.


Eligibility Criteria:
Inclusion Criteria:

* People with ultra low vision (visual acuity ≤20/1600)

Exclusion Criteria:

* \<12 years of age
* dependent on sighted guide
* cognitive impairment
Non Interventional Study of Levofloxacin in Chronic Prostatitis

Chronic prostatitis is a common disease in men with the following typical symptoms decreasing the ability to work and quality of life: pain, urination disorders, copulatory dysfunction.

Following study is conducted to study Levofloxacin in chronic prostatitis.

Chronic prostatitis is a common disease in men with the following typical symptoms decreasing the ability to work and quality of life: pain, urination disorders, copulatory dysfunction. Professional societies recommend diagnosing and treating patients with chronic prostatitis on the basis of determination of belonging to classification categories proposed by the National Institute of Diabetes and Digestive and Kidney Diseases and the National Institutes of Health in the USA .

According to the recommendations of European Association of Urologists, in chronic bacterial inflammation of the prostate and in nonbacterial (inflammatory syndrome of chronic pelvis pain), the performance of antibacterial therapy during four - six weeks is efficient. The first-line drugs are fluoroquinolones (ciprofloxacin and levofloxacin) as along with good tolerance they easily penetrate into the zones of the prostate inflammation and are highly efficient in respect of prostatitis pathogens . Although the treatment with levofloxacin promotes more evident decrease in clinical symptoms and demonstrates better parameters of eradication of pathogen in comparison with ciprofloxacin administration, it is used less common, possibly due to insufficient awareness of physicians of its high efficacy in chronic prostatitis .

Eligibility Criteria:
Inclusion Criteria:

* male patients aged from 18 to 60 years, inclusive, with a diagnosis of the chronic prostatitis, which appointed the drug Levolet® P as a causal treatment.
* Demonstrated sensitivity to levofloxacin abjection of chronic bacterial prostatitis.
* The presence of a written informed consent to participate in research

Exclusion Criteria:

* participation in another clinical study during the period of this study.