cyrilzakka/clinical-trials huggingface dataset:
QUALHYBOM Hypnosis Versus Equimolar Mixture of Oxygen and Nitrous Oxide (MEOPA) During a Bone Marrow Biopsy: a Clinical, Controlled, Randomized, Multicenter Study

The Osteo-Medullary Biopsy (BOM) is a procedure carried out by means of a trocar and makes it possible to obtain a bone core. This gesture is usually performed by performing a local subcutaneous anesthesia at the puncture point of the postero-superior iliac crest, sometimes associated with the use of MEOPA (equimolar mixture of oxygen and nitrous oxide) in case of persistence a painful perception at the puncture site during the examination, in accordance with the Guide to Good Practices for Spinal Puncture of the French Society of Hematology. However, this procedure appeared to us to be insufficient to ensure optimal comfort and effective analgesia and to effectively control anxiety. The realization of the BOM under hypnosis represents an alternative which can bring additional comfort to the patient thanks to a better tolerance and a reduction in the perception of pain. During hypnosis, it has been demonstrated that the stimulation of cortical areas in sleep and in wakefulness leads to a reduction in the pain felt by the patient. Thanks to a retrospective study carried out within the hematology department of the University Hospital of Rennes, we observed a net benefit of hypnosis on the comfort and the pain felt during the realization of a bone marrow biopsy, associated with a decrease in anxiety. In addition, the number of cubicles obtained during the examination (proportional to the size of the biopsy core) was better. Obtaining more than 10 cubicles (figure required by pathologists for a quality examination) was observed in 78% of cases with hypnotic support versus 53% without hypnotic support. Finally, the sample-taking physician reported better operational comfort when accompanied by the hypnotherapist nurse.

This original project aims, on the one hand, to improve the conditions for carrying out a procedure known to be invasive and painful and, on the other hand, to ensure better quality. So far, only one randomized study has been reported on the use of hypnosis in adults during a bone marrow biopsy showing a significant improvement in the anxiety generated by this test.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years old;
* Naive patient of BOM;
* Support at the day hospital;
* Affiliated with a social security scheme;
* Having signed a free, informed and written consent.

Exclusion Criteria:

* Patients requesting that the BOM be performed under MEOPA;
* Pregnant or breastfeeding woman;
* Emergency surgery;
* Patients consuming long-term opiates preoperatively;
* Substance addiction ;
* Patient unable to understand the rating scales;
* Palliative care patients;
* Deaf and / or dumb patients;
* Patients with psychiatric pathologies (schizophrenia, bipolarity);
* Adult persons subject to legal protection (safeguard of justice, curatorship, guardianship), persons deprived of their liberty.
Effect of Gabapentin on Idiopathic Subjective Tinnitus

The purpose of this study is to determine wether Gabapentin which is useful for treating neuropathic pains, is effective on idiopathic subjective tinnitus.

Tinnitus is the perception of sound in the absence of acoustic stimulation. It can be subjective or objective. .

Despite numerous researches,no effective treatment for people who suffer from tinnitus has yet been stablished.

As there are many evidences suggesting that loss of inhibition in the central nervous system may be responsible for many aspects of auditory dysfunction,including tinnitus; and as Gabapentin (Neurontin), a gama-aminobutyric acid (GABA) analogue, is an effective medication in conditions where inhibition in the CNS is impaired; we guess that Gabapentin might be useful for treating idiopathic subjective tinnitus.

Eligibility Criteria:
Inclusion Criteria:

* patients with subjective idiopathic tinnitus

Exclusion Criteria:

* tinnitus with known underlying cause
* pregnant women and patients younger than 18 or older than 75 years
* patients with impaired renal function
Relationship Between Nutrition and Sexual Activity

Sexuality is integral to personality, influencing feelings, thoughts, actions, and physical and mental health. Female sexual dysfunction is a fairly common condition that covers four main areas: hypoactive sexual desire disorder, arousal disorder, orgasmic disorder, and sexual pain disorder. Although incidence and prevalence rates vary, it has been reported that women range between 30% and 50%.

Male sexual dysfunction is not a single disease. Male sexual arousal refers to the entire process of sexual activity for men, including penile erection, penile penetration, ejaculation, and any obstruction in a single connection. It is a significant psychological distress for affected men, their sexual partners, and their health-related quality of life. Sexual dysfunctions are common among men of all ages and ethnic and cultural backgrounds. It is reported in the literature that 52% of men between the ages of 40-70 experience various degrees of sexual dysfunction.

Cardiovascular disease, smoking, obesity, sedentary lifestyle, diabetes, hypertension, hyperlipidemia, and metabolic syndrome are risk factors for sexual dysfunction. Although the positive effects of adopting healthy lifestyle changes and dietary habits in reducing the risks of these diseases have been proven, few studies have evaluated the impact of these treatment approaches on sexual dysfunction.

Studies evaluating the relationship between diet and erectile dysfunction have focused more on men with diabetes. Some small studies have also shown that lifestyle modification and weight loss interventions improve erectile dysfunction in men with significant cardiovascular risks. The same is valid for female sexual dysfunction. The Western diet and its components are indirectly associated with sexual morbidity. The Western diet has processed foods, refined carbohydrates, and high sodium and monounsaturated fat content, which have been widely linked to the development of MetS, obesity, and diabetes. These comorbidities are also risk factors for female sexual dysfunction as well.

This study aims to evaluate the relationship between the eating habits of obese and non-obese men and women and their sexual functions.


Eligibility Criteria:
Inclusion Criteria:

1. Female patients with menstrual bleeding
2. Sexually active male and female patients
3. 18 years and older age

Exclusion Criteria:

1. \<18 years of age
2. Female patients with menopause
3. Female patients that have undergone hormone therapy in the last 12 months
4. Sexually inactive male and female patients
5. Patients with diabetes
6. Patients with a history of psychiatric illness
7. Patients with cognitive impairment
8. Patients with hormone-dependent tumors
9. Patients taking a drug known to reduce sexual desire
TurboHawk™ Japan Trial in Patients With PAD

The objective of this study is to evaluate the safety and effectiveness of the TurboHawk for the treatment of peripheral arterial disease (PAD) in the superficial femoral and/or the popliteal arteries with the Japanese population.


Eligibility Criteria:
Inclusion Criteria:

* Provides written informed consent
* Willing to comply with follow-up evaluations at specified times
* Has a Rutherford Clinical Category Score of 2-4
* Disease located within the femoropopliteal artery
* Has evidence of ≥ 50% stenosis or occlusion in the superficial femoral and/or popliteal, confirmed by angiography
* Each discrete target lesion's length is ≥4cm and ≤ 15 cm
* Reference vessel diameter is ≥ 3.5 mm and ≤ 7.0 mm

Exclusion Criteria:

* Previously implanted stent(s) or stent graft(s) in target leg
* Life expectancy less than 12 months
* Has any planned surgical or endovascular intervention of target vessel 30 days before or after index procedure
* Has in-stent restenosis of the target lesion
* Has an aneurysmal target vessel
* Has perforation, dissection or other injury of the access or target vessel requiring additional stenting or surgical intervention prior to enrollment
A Multiple Increasing Dose Safety and Tolerability Study After Inhalation Administration of BIIX 1 XX in Healthy Male Volunteers

The objective of the present study is to obtain information about the safety and tolerability of multiple increasing doses of BIIX 1 XX and to obtain preliminary pharmacokinetic data


Eligibility Criteria:
Inclusion Criteria:

* Healthy male volunteers who have Broca-Indices within +-20%
* Participants in the age range between 21 to 50 years
* In accordance with Good Clinical Practice (GCP) and local legislation each volunteers are supposed to give their written informed consent prior to admission to the study. Subsequently each subject was to receive a complete medical examination (including blood pressure, pulse rate, medical history, documentation of demographics, inclusion/exclusion criteria and concomitant therapy) as well as a 12-lead Electrocardiogram (ECG)
* Haematopoietic, hepatic and renal function test will be carried out in the laboratory
* The subjects will fast for 12 hours before collection of specimens for all laboratory evaluations. The above mentioned examinations will be performed within 14 days before the first administration of the test substance

Exclusion Criteria:

* Any finding of the medical examination (including blood pressure, pulse rate or ECG) or laboratory tests deviating form normal and of clinical relevance
* Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
* Diseases of the central nervous system (such as epilepsy) or psychiatric disorders
* History of orthostatic hypotension, fainting spells or blackouts
* Chronic or relevant acute infections
* History of allergy/hypersensitivity (including drug allergy) which is deemed relevant to the trial as judged by the investigator
* Intake of a drug with a long half-life (\>= 24 hours) within at least one month or less than ten half-lives of the respective drug before enrolment in the study
* Use of any drugs which might influence the results of the trial within seven days prior to administration or during the trial
* Participation in another trial with an investigational drug within the last two months prior to the start of the study
* Smoker (\> 10 cigarettes or 3 cigars or 3 pipes/day)
* Inability to refrain from smoking on study days
* History of alcohol abuse and/or alcohol abuse
* Drug abuse
* Blood donation (\>100 ml) within four weeks prior to administration
* Other disease or abnormality of clinical relevance
* Excessive physical activities within two weeks prior to administration or during the trial
Developing an Integrated Model for Home Visitation

Perinatal depression is a significant concern, particularly for low-income women. Many cases of perinatal depression are complicated by comorbidities such as post-traumatic stress disorder symptoms, anxiety, and intimate partner violence. Providing perinatal mental health services to women in home visiting programs could have considerable public health significance. This study will develop and test an integrated model of mental health services embedded within home visitation (HV) programs. This model will (1) incorporate a protocol for systematic screening and referral; (2) strengthen formal linkages between HV programs and other components of service systems; (3) promote the capacity of service systems to provide evidence-based early intervention and treatment for depression; and (4) facilitate the receipt of early intervention and treatment services for perinatal depression and comorbid conditions. This will be the first model to our knowledge that systematically integrates screening, referral, and early intervention and treatment for perinatal depression and associated comorbidities within HV programs.

The specific aims are:

1. To develop an integrated model of perinatal depression care within HV programs. This integrated model ("SCRIPT") will incorporate screening, referral, and individualized prevention and treatment services.
2. To assess the feasibility of implementing the SCRIPT model with high fidelity in two HV programs. One HV program-DRUM Healthy Families-will use paraprofessionals as interventionists while the other program-M\&I Nursing-will use nurses and social workers as interventionists.
3. To determine the impact of the SCRIPT model on depressive symptoms and major depressive episodes.


Eligibility Criteria:
Inclusion Criteria:

* pregnant or child \< 6 months
* enrolled in Baltimore City home visiting program
A Behavioral Intervention for Ameliorating Sleep Problems in Children With ASD

The present study will test the effectiveness of a behavioral intervention program that targets sleep problems in 1.5-5-year-old children with ASD. Sleep patterns will be measured using questionnaires and sleep diaries that will be completed by the parents as well as by Fitbit sensors that will be placed on the child's wrist or back of the arm. The study will also explore whether specific child (e.g., severity of cognitive abilities) or parent characteristics (e.g., parent stress levels) impact the effectiveness of the intervention. In addition, we will examine whether changes in sleep disturbances are associated with changes in the family's quality of life.


Eligibility Criteria:
Inclusion Criteria:

Parents of 1.5-5-year-old children with autism will be asked to fill the Child Sleep Habits Questionnaire (CSHQ). Those who report high scores on the following 3 CSHQ subscales will be invited to participate: bedtime resistance, sleep onset delay, and night-wakings.

Exclusion Criteria:

None
Ingenio Device Algorithm Study

The purpose of the IVORY Study is to gather data to support global submissions/approvals for some models of the Ingenio device family.

IVORY is a prospective, multi-center, randomized within-patient, single-blinded study to gather data to support Right Atrial Auto Threshold and RYTHMIQ

Eligibility Criteria:
Inclusion Criteria:

* Subjects who are willing and capable of providing informed consent to undergo a device implant and to participate in all testing associated with this clinical study;
* Subjects whose age is 18 or above, or of legal age to give informed consent specific to national law;
* Subjects indicated for a dual chamber pacemaker or a CRT-P device according to class I or class II indications of the standard ESC or ACC / AHA implant guidelines;
* Subjects who are planned to be implanted with all leads intended for a specific device type (dual chamber pacemaker: atrial and right ventricular lead, CRT-P: atrial, right and left ventricular lead) or are already implanted with such leads;
* Subjects who receive or are implanted with a bipolar atrial lead.

Exclusion Criteria:

* Women of childbearing potential who are or might be pregnant at the time of the study (method of assessment upon physician's discretion);
* Enrolled in any other concurrent study, with the exception of local mandatory governmental registries and observational studies/registries that are not in conflict or affect
* Schedule of procedures for IVORY (i.e. should not cause additional or missed visits);
* Programming of devices for IVORY per CIP;
* IVORY outcome (i.e. involve medications that could affect the heart rate of the subject);
* Conduct of IVORY per GCP / ISO 14 155:2011 / local regulations.
* Subjects who live at such a distance from the clinic that travels for FU visits at a study center would be unusually difficult or burdensome for the subject;
* Inability or refusal to comply with the FU schedule;
* A life expectancy of less than 12 months, per physician discretion;
* Subjects who are planned to be programmed to a pacing mode other than DDD / DDDR during the study period.
Placement of Peripheral Venous Catheters Under Echo Guidance in a Post-emergency Medical Service

Compare the number of attempts to place a peripheral venous catheter in the group of patients hospitalized in the post-emergency unit and benefiting from echo guidance and therapeutic communication, to the group of patients hospitalized on the post-emergency unit using traditional technique.


Eligibility Criteria:
Inclusion Criteria:

* Hospitalized in the post-emergency unit
* Requiring the placement of a venous catheter in the post-emergency unit
* Affiliation to social security or benefiting from such a scheme
* Informed and written consent signed

Exclusion Criteria:

* Protected person (art. L1121-5 to L1121-8 of the CSP)
* Patient included in another interventional study
* Patient already included for a first catheter placement in the post-emergency unit.
How Early Mobilization Impacts on Diaphragm Thickness in Critically Ill Children

The objective is to compare the impact of early mobilization and routine care on diaphragm thickness in critically ill children

Mechanical ventilation is a life-supporting therapy that intrinsically induces diaphragm rest. Consequently, mechanical ventilation induces time-dependent diaphragm weakness in animals and in critically ill patients, and is referred to as ventilator-induced diaphragm dysfunction (VIDD).

In most cases with VIDD, the decrease in diaphragm thickness can be detected by bedside Ultrasonography. The onset of diaphragm atrophy in the intensive care unit could be very rapid (fewer than 5 days). Vivier E. defined muscle atrophy as greater than or equal to a 10% decrease in muscle thickness on day 5 compared to day 1. It's found that diaphragm atrophy occured in 17/35 (48%). However, There is always some cases presented an increase in diaphragm thickness. Goligher EC. reported that approximately 20% of mechanically ventilated patients exhibit an increase in diaphragm thickness. In our previous study, there were about 46.7%(14/30) of ventilated children had increased diaphragmatic thickness. It's supposed that the thickening might associated with the diaphragm injury during mechanical ventilation.

Early mobilization may enhance the weaning of ventilated children, so the investigators hypothesize that the percentile of cases with increase diaphragmatic thickness will decline by early mobilization. To investigate this hypothesis, investigators are conducting a randomized trial examining the effects of early mobilization versus routine care on changing tendency of diaphragm thickness.

Enrolled children requiring mechanical ventilation will be randomized to either early mobilization group or routine care group. Diaphragm thickness will be measured by ultrasound on day1, day3, day5 and day7 after intubation and subsequently diaphragm thickness changing tendency will be calculated in each arm. The operator acquiring ultrasound images will be blinded to the care mode that the subject was randomized to. Subjects in the study will follow standard ICU sedation awakening trials and spontaneous breathing trials. The medical team in charge of the subject will determine when the subject is safe to receive early mobilization according to the standard established along with the rehabilitation team.

Eligibility Criteria:
Inclusion Criteria:

* subjects \> 6 months and \< 12 years of age；
* subjects been intubated and mechanically ventilated for \< 24 hours at the time of screening;
* the Glasgow Coma Scale (GCS) on admission of Pediatric Intensive Care Unit (PICU) is greater than 3

Exclusion Criteria:

* cardiopulmonary arrest;
* history of diaphragmatic paralysis or neuromuscular disease;
* neuromuscular blockade;
* expectation to be liberated from ventilator in \< 24 hours
* history of mechanical ventilation in the last 6 months
* presence of tracheostomy
* high cervical spine injury
* status convulsion
* thoracic trauma when ultrasonic examination cannot be performed
A Study in Healthy Volunteers Investigating How Quickly and to What Extent BAY1817080 is Taken up, Distributed, Broken Down and Eliminated From the Body, as Well as the Difference Between 2 Different Types of Tablets of BAY1817080 and the Difference Between Oral Dose and Dose in the Vein

The main purpose of this study is to investigate how quickly and to what extent BAY1817080 is absorbed (taken up), distributed, metabolized (broken down) and eliminated from the body (this is called pharmacokinetics). The pharmacokinetics of BAY1817080 administered as tablets will be compared to the pharmacokinetics of BAY1817080 administered as intravenous (iv; in the vein) infusion (this is called absolute bioavailability). Furthermore, 2 different types of tablets with BAY1817080 (Formulation A and Formulation B) will be compared with regard to pharmacokinetics (this is called relative bioavailability). The effect of a meal on the pharmacokinetics of BAY1817080 administered as tablets will be investigated as well. Finally, it will also be investigated how safe BAY1817080 is and how well BAY1817080 is tolerated.


Eligibility Criteria:
Inclusion criteria:

* Healthy male subject
* Age: 18 to 55 years (inclusive) at the time of informed consent and first dose of study medication
* Body mass index (BMI) above/equal to 18 and below/equal to 30 kg/m\^2 at Screening
* Body weight of at least 45 kg at Screening

Exclusion criteria:

* Presence or history of clinically relevant cardiovascular, central nervous system (CNS), hepatic, hematopoietic disease, renal dysfunction, metabolic or endocrine dysfunction, serious allergy, asthma hypoxemia, hypertension, seizures, or allergic skin rash
* Known hypersensitivity to the study drugs
* Known severe allergies or significant non-allergic drug reactions
* Febrile illness within 1 week before study drug administration
* Current or recent (within 6 months) gastrointestinal disease that would be expected to influence the absorption of drugs
* Subject has a history of cancer, except basal cell carcinoma which has been in remission for at least 5 years prior to Screening
* Poor peripheral venous access
* Regular use of medicines within 6 months prior to screening
* Clinically relevant findings in the electrocardiogram (ECG), physical examination or laboratory examination
Phase 1 Intravenous Citrulline for the Prevention of Bronchopulmonary Dysplasia in Preterm Infants

Premature infants are at risk for developing bronchopulmonary dysplasia (BPD). L-citrulline may decrease that risk, but we do not know the safety or dose of this drug for use in premature babies. The purpose of this study is to determine the safety and optimal dose of intravenous L-citrulline in premature infants.

This is a prospective phase I study of the safety, pharmacokinetics, and optimal dose of intravenously administered L-citrulline in premature infants born at 24 to 29 weeks estimated gestational age (EGA) and who are at risk for bronchopulmonary dysplasia (BPD). This is a classic dose escalation using initial doses of 10 mg/kg of intravenous citrulline and advancing the dose by 10 mg/kg every 3 patients for a target peak plasma citrulline concentration of 100 umol/L. These infants will undergo intense hemodynamic monitoring and have intermittent blood sampling to determine levels of amino acids and nitric oxide metabolites. From this, we will determine citrulline pharmacokinetics including half life, clearance, and volume of distribution. Intravenous L-citrulline will be provided by Asklepion Pharmaceuticals and mixed by the Investigational Drug Service of the Vanderbilt Hospital Clinical Pharmacy. The study will be monitored closely by a data safety monitoring board (DSMB) consisting of clinicians not involved with this study.

Eligibility Criteria:
Inclusion Criteria:

* 24-29 Weeks Gestation
* Respiratory Distress requiring intubation and mechanical ventilation or positive pressure oxygen at 24 hours of life
* Parents willing and able to sign consent

Exclusion Criteria:

* Congenital malformation
* Suspected genetic or metabolic syndrome
* Surgical condition
* Life expectancy \< 24 hours
* Pre-existing, sustained hypotension
* Birth weight \< 500 grams
* Any condition which, in the opinion of the investigator, will interfere with the study objectives.