cyrilzakka/clinical-trials huggingface dataset:
Heart Rate Variability Biofeedback for Female Sexual Arousal Disorder

Low resting heart rate variability (HRV) has been associated with sexual arousal problems and overall sexual dysfunction in women. Research has indicated that HRV biofeedback leads to increases in HRV as well as improvements in symptoms associated with several psychological disorders, some of which are comorbid with sexual arousal problems in women. Autogenic training also facilitates increases in HRV and was recently associated with acute increases in sexual arousal among sexually healthy women. The primary aim of the current study is to examine the efficacy of HRV biofeedback, with and without autogenic training, for the treatment of female sexual arousal disorder (FSAD).

Women who meet ICD-10-CM diagnostic criteria for FSAD will be recruited and randomized into one of three conditions, HRV biofeedback (n = 25), HRV biofeedback plus autogenic training (n = 25), or wait-list control (n = 15). All participants will complete a baseline assessment, during which their resting state HRV and vaginal pulse amplitude (VPA) will be measured. The participants in the two biofeedback conditions will receive training in HRV biofeedback from the experimenter, and they will be provided with the materials necessary to guide self-practice in HRV biofeedback at home. Participants in these two conditions will be instructed to engage in at-home HRV biofeedback (with or without autogenic training) at least 5 times over a period of two weeks, during which they will report levels of arousal in a sexual activity diary. Participants in the wait-list control condition will report levels of arousal in a sexual activity diary. After two weeks, participants in all three conditions will return to the laboratory, where their physiological and psychological sexual arousal will be measured. Over the next two weeks, participants in the two biofeedback conditions will be asked to complete 5 more self-guided biofeedback sessions along with the sexual activity diary. Participants in all three conditions will return to the lab for a final assessment to measure post-treatment HRV and VPA levels as well as psychological sexual arousal. To our knowledge, this study will be the first randomized controlled trial of HRV biofeedback in women with sexual arousal problems. If the intervention increases arousal in this population, this study may offer a promising cost-effective psychosocial treatment for women with sexual arousal problems.

Eligibility Criteria:
Inclusion Criteria:

* Premenopausal (18-40 years)
* Fluent in English
* Heterosexual or bisexual
* Score of 26.55 or less on the Female Sexual Function Index (FSFI)
* Current sexual arousal dysfunction
* Ownership of an Elite HRV compatible device (recent iPhone, iPad, or Android)

Exclusion Criteria:

* Pregnant or breastfeeding
* History of or current sexually transmitted infections
* History of major pelvic surgery
* History of childhood sexual abuse
* Currently taking androgens, estrogens, or other medical treatments to enhance sexual arousal
* Current psychosis
* If on antidepressants or antihypertensives, must be stabilized for at least 3 months
CrescNet - Growth Monitoring Network

CrescNet is a network of primary care physicians and pediatricians (n=219) and endocrinological treatment centers (n=33), established in Leipzig in 1998, whose aim is to improve the early detection of growth disorders. Secondary to this clinical aim, epidemiological analyses, for example on secular trends of growth data of children, are performed.

Pediatricians participating in CrescNet provide pseudononymized data on patients' height, weight, and head circumferences to the CrescNet registry. Growth data are evaluated by automatized filter algorithms and by a pediatric endocrinologist. CrescNet does not have access to patients or personal patient data. Each participating pediatrician receives a quarterly screening report with recommendations for the work-up of children with abnormal growth or abnormal development of weight or body mass index.

The data registry is used for scientific purposes.The collection of data from healthy children allows the generation of evidence based statements about prevalence rates of growth disorders and also about the rates in disorders of weight development. For this, data are provided completely anonymized without allowing conclusions on personal patient data.

Eligibility Criteria:
Inclusion Criteria: Population based sample with inclusion of any patient seen by primary care or institutional physician/pediatrician, regardless of the objective for the visit (well child visits, acute visits or special requests)

Exclusion Criteria: none
Remotely Delivered Behavioral Weight Loss Using an Ad Libitum Plant-Based Diet Versus a Balanced Calorie Deficit Diet

This pilot randomized controlled trial will compare a remotely delivered behavioral weight loss program with a balanced calorie deficit diet (the current gold-standard) to a behavioral weight loss program with an ad libitum whole food plant-based diet (WFPBD) amongst adults with overweight/obesity (N = 52). The 6-month intervention will consist of 3 months of moderate-intensity intervention (weekly online modules and brief coaching calls), then a low-intensity period (3 calls over 3-months). Assessments will occur at baseline, 6-weeks, 12-weeks, and post-treatment (6-months). Acceptability, dietary adherence, weight, quality of life, depressive symptoms, and subjective appetite will be assessed.


Eligibility Criteria:
Inclusion Criteria:

* BMI 27-50 kg/m2
* Ages 18-75 years
* Resides in the U.S.
* Consistent access to internet at home
* Proficient skill level in speaking, writing, and understanding English
* Reporting a desire to lose weight
* Consistently available for 15-minute once-weekly video appointment between the hours of 8 AM and 7 PM EST
* Willing to follow a whole food plant-based diet or a traditional calorie-reduced diet for the study duration
* Individuals must provide consent for the research team to contact their personal physician if necessary, to provide clearance or to consult about rapid weight loss

Exclusion Criteria:

* Currently pregnant or breastfeeding or planned pregnancy within the study period
* Recent weight loss (≥ 5% weight loss in 3-months prior to the study)
* History of bariatric surgery
* Currently following a low-fat plant-based diet
* Medical condition (e.g., cancer, type I diabetes, renal failure), current substance use problem, or psychiatric condition (e.g., active substance abuse, eating disorder) that may pose a risk to the participant during intervention or cause a change in weight
* Recently began or changed the dose of a medication that can cause significant change in weight
* Planning on quitting cigarette smoking over the program period
* Participation in a concurrent weight loss program during the study period
* Medical diagnosis currently influencing weight or appetite
* Medical condition that would limit ability to participate in this program (for example, mild stroke, diabetes if taking insulin, head trauma, cognitive disorder)
* Acute suicidality
* Currently meets criteria for regular loss-of-control eating (i.e., ≥ 9 binge episodes in past 3 months
* Currently reports engaging in a compensatory behavior
The Magnitude of Inter-limb Asymmetry and Its Assocation with Inter-limb Asymmetry in Distance Runners and Non-runners

Distance running is one of the most popular and most accessible ways to engage in physical activity. Although distance running offers numerous health-related benefits and protects against noncommunicable diseases (e.g., type 2 diabetic, obesity, hypertension), research has indicated a high prevalence of running-related injuries with a more pronounced incidence among novice runners (i.e., 17.8 injuries per 1000h) compared to their highly trained peers (i.e., 7.2 injuries per 1000h).

Interlimb asymmetry has previously been related to higher injury risk as well as to impaired sports performances. Nevertheless, to date, research on the degree and evolution of functional asymmetry (e.g., unequal strength between limbs) in distance runners is scarce and the role of functional asymmetries in running performance and running-related injuries remains unclear. Moreover, and despite the great number of unilateral tests available in the literature, there currently exists no reliable and run-specific field-based test battery to examine the degree of lower limb asymmetry in distance runners. Therefore, this study aims to assess the test-retest, intra- and inter-rater reliability of a newly created running-specific field-based test battery to assess the presence and degree of functional lower limb asymmetry among novice, moderatly and highly trained distance runners as well as a control group of non-athletes. The second objective is to assess the association between inter-limb asymmetry and running performance.


Eligibility Criteria:
Inclusion Criteria:

* • Being aged between 20 and 50 years at Tfamiliarization

  * Being free from any medical attention injury (i.e., injury that results in a participant receiving medical attention) for at least 6 months upon Tfamiliarization
  * Speaking Dutch, French or English
* Highly trained distance runners:

  * Running at least 150km per month for at least 3 months

Moderately-trained runners:

* Running between 40 - 150 km per month for at least 6 months

  - Novice distance runners:
* Running not more than 10km per week for the past 12 months

  - Control group of non-athletes
* Performing \<75min of systematic moderate to vigorous-intensity physical activity per week and having no experience in systematic (un)structured running activities for the past 5 years

Exclusion Criteria:

* • Being younger than 20 years or older than 50 years at Tfamiliarization

  * Any known relevant medical history or current condition (e.g., neurological diseases, inner ear diseases) that could affect the performance of the functional tests (e.g., balance in repeated hop tests)
  * Participants that have undergone a surgery at lower limb level during the past 6 months
  * Medication or drug use (e.g., blood pressure medicines)that could affect the performance of the functional tests (e.g., balance in repeated hop tests)
  * Participants performing more than two hours per week of unilateral sports (e.g., tennis or soccer)
Effects of CHONDRON (Autologous Chondrocytes) With Ankle Cartilage Defect

An open clinical trial transplanting CHONDRON (autologous chondrocytes) to ankle cartilage defect patients who are appropriate for the trial, and evaluating the validity and safety for 12 months.

This clinical trial was designed to observe effects of CHONDRON (autologous chondrocytes) for 12 months in patients with ankle cartilage defects. In this clinical trial, 30 subjects were screened- 4 were excluded half way and 26 finished the trial. Full-thickness articular cartilage specimen was obtained from sites that do not have direct articulation within the ankle joint(anterior talus, anterior process of calcaneus, calcaneocuboid joint area.) Gel-type CHONDRON (Fibrin mixed Autologous chondrocytes) was transplanted at the defects. Evaluation variables were AOFAS, 100 mm VAS, HANNOVER score, self-assessment of improvement by the patient, MRI and arthroscopy.

Eligibility Criteria:
Inclusion Criteria:

1. adult men and women over 15 and less than 65 years of age
2. applied to patients with arthroscopically or grossly confirmed, partial cartilage defect at the ankle joint
3. patients with ankle-tibia malalignment of the ankle joint, unstable ankle ligaments, bone defects at the cartilage defect area or patients who received correction in advance.
4. patients which surrounding cartilage are normal
5. patients who agreed to clinical trial participation voluntarily or by the will of the person in parental authority, and signed the written consent form

Exclusion Criteria:

1. patients hypersensitive to bovine protein
2. patients hypersensitive to gentamicin antibiotics
3. patients with inflammatory arthritis such as rheumatoid arthritis, gout arthritis
4. patients with arthritis related to autoimmune disease
5. pregnant, breast-feeding patients or those who have a possibility of pregnancy
6. patients with accompanying diseases other than articular cartilage defects, including tumors
7. patients who have a history of receiving radiotherapy, chemotherapy in the last 2 years
8. patients with diabetes (however, patients whose blood sugar test results are normal and do not have any complication of diabetes, when a written opinion that CHONDRON administration is possible is appended by a doctor are excluded)
9. patients who are administering antibiotics and antimicrobial agents due to infection
10. patients who receive steroid hormone therapy
11. Patients with psychiatric disorder and those who are considered to be inappropriate for this trial by the judgment of the clinical trial manager
The Effect of a Liquid Protein Modular on Growth and Outcomes in the NICU

The investigators hypothesis that premature infants receiving a commercially available liquid protein modular will have improved growth when compared with premature infants receiving a commercially available powder protein modular.


Eligibility Criteria:
Inclusion Criteria:

* Infants less than 2000 gms at birth, receiving maternal breast milk

Exclusion Criteria:

* Infants receiving formula
Levels of Inflammation in Middle East People With Cardiovascular Disease With/Without Kidney Disease

This study will collect medical and background information from participants with diseases that affect the heart and blood vessels (cardiovascular disease) with/without kidney disease.

The aim of the study is to assess the number of people with high levels of systemic inflammation among Middle East people with cardiovascular with/without kidney disease. Systemic inflammation means that it occurs throughout the body.

Participation in this study only requires a single visit at the clinic/hospital/medical institution. Participants will continue their normal care and will not get any treatment as part of this study.


Eligibility Criteria:
Inclusion Criteria:

1. Informed consent obtained before any study-related activities (study-related activities are any procedure related to recording of data according to the protocol).
2. Male or female, age above or equal to 18 years at the time of signing informed consent.
3. Diagnosed with ASCVD+CKD and/or HF (pEF or mrEF)

Exclusion Criteria:

1. Previous participation in this study. Participation is defined as having given informed consent in this study.
2. Current participation (i.e., signed informed consent) in any other interventional clinical study.
3. Any hospitalization or unplanned visit within the last 60 days (including exacerbation of chronic disease with hospitalization).
4. Clinical evidence, or suspicion of, active infection within the last 60 days.
5. Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation.
A(f)MAZE-CABG Study

Concomitant AF ablation with HIFU in patients with persistent or long standing persistent AF undergoing CABG will be superior in restoring SR, compared with patients with persistent or long standing persistent AF undergoing CABG treated with best medical treatment according to ACC/AHA/ESC 2006 guidelines and no AF ablation.

Primary Objective

• To compare the efficacy of concomitant AF ablation using HIFU to no ablation at 12 months in patients with persistent or long standing persistent AF undergoing CABG according to ACC/AHA/ESC 2006 guidelines and HRS/EHRA/ECAS Consensus Statement on Catheter and Surgical Ablation .

Secondary Objectives

* To compare the safety of concomitant AF ablation using HIFU to no ablation in patients with persistent or long standing persistent AF undergoing CABG.
* To compare AF burden in patients with persistent or long standing persistent AF treated with concomitant HIFU AF ablation undergoing CABG to those receiving no ablation.
* To compare the quality of life of patients with persistent or long standing persistent AF treated with concomitant HIFU AF ablation undergoing CABG to those receiving no ablation.
* To compare the health economic impact of concomitant AF ablation with HIFU in patients with persistent or long standing persistent AF undergoing CABG to those receiving no ablation.
* To compare the morbidity associated with persistent or long standing persistent AF in patients following CABG and ablation compared to those receiving no ablation.
* To compare cardiac function and left atrial transport associated with persistent or long standing persistent AF patients following CABG and ablation compared to those receiving no ablation.
* To document the incidence of immediate post ablation bidirectional conduction block through the pulmonary venous cinch and mitral lines.
* To document the effect of Intra-operative pre and post ablation stimulation and ablation of the autonomic ganglia.

Eligibility Criteria:
Inclusion Criteria:

* Legal age in host country
* Scheduled for CABG surgery
* Patient suffering from persistent or long-standing persistent AF
* Patients having the ability to fully comply with the study requirements
* Life expectancy \> 2 years
* Patients who have given written informed consent to participate in the study

Exclusion Criteria:

* Clinically significant local or systemic infection or active endocarditis
* Sutures, pacing/defibrillator leads on the left side of the heart, valve prostheses or rings, or other implanted material in or adjacent to target treatment area.
* Stent in the coronary artery preventing an adequate mitral line
* Any other concomitant operation on the heart
* Previous heart surgery
* Patients who are or may potentially be pregnant
* Previous catheter ablation for atrial arrhythmia
* LA size more than 60 mm in apical view on Trans-Thoracic Echocardiogram (TTE)
* LA thrombus on intra-operative Trans-Oesophageal Echocardiogram (TOE)
* Known contraindication to Amiodarone
* Inability to undergo TOE
* Patients who are unable to give full informed consent for the study.
Pulmonary Embolism and Stroke in Patient With Patent Foramen Ovale

The cause of ischemic stroke remains frequently unknown. In patients with patent foramen ovale (PFO), the link between PFO and Stroke is unclear. The investigators hypothesize that the main mechanism is paradoxical embolism and decided to look for clinically apparent and silent cerebral embolism in patients with a recent pulmonary embolism.

Inclusion criteria :

* age \> 18 years old
* confirmed pulmonary embolism
* informed consent
* social ensured

Exclusion criteria :

* pregnancy
* age \< 18 years old
* protected major person (in sense of public health)
* consent refused
* MRI contraindications

Eligibility Criteria:
Inclusion Criteria:

* age \> 18 years old
* confirmed pulmonary embolism
* informed consent
* social ensured

Exclusion Criteria:

* pregnancy
* age \< 18 years old
* protected major person (in sense of public health)
* consent refused
* MRI contraindications
Dynamic Stretching Training and Muscle Tendon Unit

The purpose of this study is to investigate the effects of a 5-week dynamic stretching exercise training on muscle-tendon unit of gastrocnemius muscle.

Muscle stretching is a common practice applied in warm-up process to enhance performance in sports and to prevent or decrease the risk of sports injury. Muscle stretching is also used for therapeutic purposes in many clinical conditions.

It is generally performed in either static or dynamic manner. The effects of stretching depend on the type, duration and timing of stretching. However, the acute and chronic effects of a stretching can be different in the same muscle.

Recent studies suggest that static stretching has adverse effects on performance, reduces maximal muscle force and is not successful in preventing non-contact injuries, as believed so. Dynamic type is reported to improve flexibility and range of motion better. But there is still debate over which prescription provides the best results in terms of flexibility, power, performance or injury protection. And the answer to the question what happens to the viscoelastic properties of a muscle when it is stretched dynamically for some period of time has not been clearly established.

This study is planned to investigate the effect of a 5-week dynamic stretching exercise training on muscle tendon unit of gastrocnemius muscle. The effects of the training program will be assessed by ultrasound.

Eligibility Criteria:
Inclusion Criteria:

* Inclusion Criteria:
* Healthy males,
* aged between 18-30 years

Exclusion Criteria:

* Cases with history of recent musculoskeletal injuries or neurological diseases.
Optimization of VIM Targeting in Essential Tremor Surgery

Deep brain stimulation (DBS) for essential tremor is based on the intermedius ventralis nucleus of the thalamus (VIM) stimulation. This structure is however very difficult to target, as it remains invisible on imaging. The current procedure based on awake surgery with clinical and electrophysiological testings has several limitations that lead us to develop a probabilistic model to locate precisely the target. This study aims to show that asleep DBS surgery based on this new targeting method leads to at least the same clinical results than the classical procedure.

The intermedius ventralis nucleus of the thalamus (VIM), which represents the target for deep brain stimulation (DBS) in essential tremor, still remains invisible on 1,5 tesla MRI (the only magnetic field available for stereotactic surgery). The target coordinates currently used are based on stereotactic atlases or mean coordinates from retrospective series. They are so imprecise that intra-operative clinical testing and micro-electrode recordings are mandatory to locate the exact position of the VIM. This procedure is long lasting, requires that the patient is awake, and increases the risk of intracerebral haemorrhage and nosocomial infections. Furthermore, some patients are not improved despite a DBS lead implanted in the electrophysiologically and clinically defined target. To overcome these limitations, investigators developed a probabilistic model based on data extracted from imaging of patients with particularly good outcomes after DBS surgery. This machine-learning model allows calculating to coordinates of the VIM according to the position of radio-anatomical landmarks with a mean precision of 1,65mm.

The aim of this study is to validate this new targeting method on a prospective cohort of patients. DBS surgery will be performed under general anaesthesia, without intra-operative clinical and electrophysiological testing, with a surgical robot and under CT-scan guidance (O-Arm ©).

Neurostimulation device programming will be performed as usual. Patients' tremor and quality of life will be evaluated pre and post-operatively at 3 months, according to the Fahn-Tolosa-Marin (FTM) scale and with an accelerometry recording (for tremor) and with the mPDQ-39 scale for quality of life. Surgical complications and side effects related to neurostimulation will be gathered all along the follow-up.

Eligibility Criteria:
Inclusion Criteria:

* Severe essential tremor despite the optimal medical management
* Age between 18 and 75 years
* Normal MRI scan
* Mattis Dementia Rating Scale (MDRS) score ≥ 130
* Affiliation to the social security
* Signed informed consent

Exclusion Criteria:

* Depression (Beck Depression Inventory scale \> 20)
* Contra-indication to surgery or general anesthesia
* Cerebral atrophy on MRI scan
* Pregnant or breastfeeding women