cyrilzakka/clinical-trials huggingface dataset:
Human Sperm Markers of Cryodamage Resistance

Sperm freezing has been employed for decades for male fertility preservation in cases of foreseeable or unexpected loss of fertility to guarantee future paternity, and also as a complement of assisted reproduction techniques.

Sperm quality after thawing is highly variable, even among consecutive samples from the same individual, with mean survival rates around 40%. To date, the molecular basis of the adequate resistance or intolerance to freezing/thawing protocols is unknown, and its knowledge can lead to improvement in the selection of the samples to be frozen and also in the adequate supplement of cryopreservation media. Microarray analysis provides a powerful tool to address the molecular explanation beyond this behaviour, yielding results about comparative messenger ribonucleic acid (mRNA)expression under the two different biological conditions: optimal and suboptimal survival.

Then, the aim of the investigators' study is to determine the genomic profile of sperm samples depending on their survival resistance to cryopreservation, to determine genes involved in cryodamage sensitivity.

Nested cases and controls design, with donor sperm samples frozen under conventional protocols, categorized depending on their good (GSR, n=20) (less than 20% motility decrease) or bad (BSR, n=20) (more than 20% motility decrease) survival rates. Sperm mRNA was extracted using Trizol protocol, suspended in diethylpyrocarbonate (DEPC)-treated water and frozen at -80 degrees until the microarray experiments were performed. RNAs were analyzed on Agilent Bioanalyzer 2100. Samples were pooled in 4 (5 samples/pool and 4 pools/group). Finally, 8 Agilent One colour Whole genome microarray (44K) were performed with pooled samples, 4 microarrays per group.

The results will be evaluate to detect those genes differentially expressed.

Eligibility Criteria:
Inclusion Criteria:

The criteria used for the inclusion of donors in the sperm bank will be considered:

* males from 18 to 35 years.
* good physical and psychological conditions and no hereditary diseases
* seminal parameters: concentration \> 40 million sperm / ml; percentage of progressive motility\> 50% percentage of normal forms\> 4%.
* For pregnancy rates after artificial insemination, only women\< 40 years without tubal pathologies and artificial insemination indications will be included.

Exclusion Criteria:

All the population not included in the list of inclusion will be excluded.
Exposure Therapy for Active Duty Soldiers With Post Traumatic Stress Disorder

This study is evaluating the efficacy of virtual realty exposure therapy (VRET)by comparing it to prolonged exposure therapy (PE) and a waitlist (WL) group for the treatment of post traumatic stress disorder (PTSD) in active duty (AD) Soldiers with combat-related trauma. The investigators will test the general hypotheses that 10 sessions of VRET or PE will successfully treat PTSD, therapeutically affect levels of physiological arousal, and significantly reduce perceptions of stigma toward seeking behavioral health services.

The rationale for this study is based on growing evidence demonstrating that VRET is an efficacious treatment for PTSD and holds the potential to improve access to care for Soldiers who would otherwise avoid treatment. Although PE is considered one of the most effective cognitive-behavioral therapies (CBT) for treatments for PTSD, there are reasons why it may not be the most viable option for many Soldiers. First, Prolonged exposure requires a level of emotional engagement during exposure to the trauma that many patients are unable to obtain. Second, stigma and concerns about how Soldiers will be perceived by peers and leadership has a dramatic impact on whether a Soldier will seek care. VRET may address these concerns and may also improve treatment outcomes and access to care by augmenting the patient's re-living of the trauma with a sensory-rich environment and moderating stigma perceptions by offering non-traditional treatment that is a preferable option for many Soldiers who are reluctant to seek out traditional talk therapies. Despite its promise as a viable treatment option, few studies have examined VRET for combat-related PTSD and there are no published studies that have compared VRET to PE in the treatment of combat-related PTSD. Positive results may provide new treatment options for all Soldiers, but should prove to be an especially attractive option for Soldiers who either do not respond to, or are reluctant to engage in other established therapies such as PE.

Eligibility Criteria:
Inclusion Criteria:

* PTSD diagnosis as assessed by CAPS
* history of deployment in support of OIF/OEF
* non sexually based deployment related trauma
* three or more months since index trauma
* stable on psychotropic medications for 30 days

Exclusion Criteria:

* index trauma in the last three months
* history of schizophrenia, other psychotic or bipolar disorder
* history of organic brain disorder
* suicidal risk or intent or self-mutilating behavior requiring hospitalization in the last 6 months
* ongoing threatening situation
* current drug or alcohol dependence
* history of seizures
* prior history of PE for PTSD
* other current psychotherapy
* physical condition that interferes with proper use of Virtual Reality head mounted display
* history of loss of consciousness since entering active duty service greater than 15 minutes
A Study to Evaluate Efficacy and Safety of VX-150 in Subjects With Acute Pain Following Bunionectomy

This is a Phase 2 randomized, double-blind, placebo-controlled, 3-arm, parallel design study to evaluate the efficacy and safety of VX-150 in treating acute pain following bunionectomy.


Eligibility Criteria:
Inclusion Criteria:

Prior to Surgery:

* Body mass index (BMI) of 18.0 to 38.0 kg/m2, inclusive
* Be scheduled to undergo a primary unilateral first metatarsal bunionectomy repair, without collateral procedures, under regional anesthesia (Mayo and popliteal sciatic block) not to include base wedge procedure

After Surgery:

* Subject reported pain of ≥4 on the NPRS, and moderate or severe pain on the Verbal Categorical Rating Scale (VRS) within 9 hours after removal of the popliteal sciatic block on Day 1
* Subject is lucid and able to follow commands
* All analgesic guidelines were followed during and after the bunionectomy

Exclusion Criteria:

Prior to Surgery:

* History in the past 10 years of malignancy, except for squamous cell skin cancer, basal cell skin cancer, and Stage 0 cervical carcinoma in situ
* History of cardiac dysrhythmias requiring anti-arrhythmia treatment(s)
* History of abnormal laboratory results ≥2.5 × upper limit of normal (ULN)
* History of peripheral neuropathy
* A known or clinically suspected infection with human immunodeficiency virus or hepatitis B or C viruses
* Prior medical history of bunionectomy or other foot surgery
* Intolerant of or unwilling to receive hydrocodone, acetaminophen, or ibuprofen
* For female subjects: Pregnant, nursing, or planning to become pregnant during the study or within 90 days after the last study drug dose
* For male subjects: Male subjects with a female partner who is pregnant, nursing, or planning to become pregnant during the study or within 90 days after the last study drug dose

After Surgery:

* Subject had a type 3 deformity requiring a base wedge osteotomy or concomitant surgery such as hammertoe repair; or experienced medical complications during the bunionectomy that, in the opinion of the investigator, should preclude randomization

Other protocol defined inclusion/exclusion criteria may apply.
Percutaneous Pinning Versus Plate and Screws for Surgical Fixation of Proximal Humeral Fractures

The aim of this multicenter nonrandomised study is to prospectively compare the clinical and radiographic results of two different techniques of surgical fixation of proximal humeral fractures: percutaneous pinning versus plate and screws.


Eligibility Criteria:
Inclusion Criteria:

* \&gt; 18 year old
* proximal humeral fracture
* both X-rays and CT scan available

Exclusion Criteria:

* dementia
* psychiatric disease
Clinical Study to Evaluate the RxSight Light Adjustable Lens With the Light Delivery Device in Subjects With Preoperative Corneal Astigmatism

For patients undergoing cataract surgery, the purpose of this study is to evaluate a patient's far vision without glasses and quality of vision after implantation and UV treatment of the RxSight Light Adjustable Lens (RxLAL).Following completion of all light treatments, the patient's far vision without glasses and quality of vision will be assessed 6 months postoperatively.


Eligibility Criteria:
Inclusion Criteria:

* Must sign a written Informed Consent form and be willing to undergo cataract surgery for the bilateral implantation of the RxLAL.
* Greater than the age of 40 on the day the cataract surgery is performed.
* Preoperative keratometric cylinder of \>=0.50 D and \<=4.00 D in both eyes.
* Cataract causing reduction in best corrected distance visual acuity (BCDVA) to a level of 20/32 or worse with or without glare source in both eyes.
* Willing and able to comply with the requirements for study specific procedures and visits.

Exclusion Criteria:

* Zonular laxity or dehiscence.
* Age-related macular degeneration involving the presence of geographic atrophy or soft drusen.
* Retinal degenerative disorder or macular disorder (other than mild macular degeneration) that is expected to cause future vision loss.
* History of uveitis
* Keratoconus or suspected of having keratoconus.
* Previous corneal or intraocular surgery, except eyes with previous pterygium excision are permitted as long as the pterygium did not extend more than 2mm onto the cornea from the limbus.
* Serious co-morbid conditions that in the judgement of the investigator makes inclusion in the study not in the best interest of the subject.
* Subjects taking systemic medications that may increase sensitivity to UV light.
* Subjects taking a systemic medication that is considered toxic to the retina such as tamoxifen.
* History of ocular herpes simplex virus
* History of congenital color vision defect
Evaluation of the Effect of Virtual Reality on Pain in the Management of Chronic Wounds.

Pain management is a priority axis of health insurance spending objectives and contributes to improving the quality of care.There are several types of pain: acute, chronic and induced. These are often found in the management of chronic wounds. The high prevalence of chronic wounds represents a major public health problem. Chronic wounds require long, painful and regular treatment. When dressing these wounds, pain management is essential. Indeed, it can generate healing delays. Usually, pharmacological methods are used to reduce the pain induced by care. But these methods can lead to undesirable effects. Thus, new non-pharmacological techniques are emerging.The investigators therefore wish to assess the effect of virtual reality on pain induced by care during the repair of dressings in the management of chronic wounds.


Eligibility Criteria:
Inclusion Criteria:

* Adults
* Knowing how to read and write French
* Able to understand the issues of the study and give consent
* Carrier of a chronic wound (ulcers, bedsores or wounds of the diabetic foot)
* Requiring a weekly dressing treatment in the department for at least 4 successive treatments(4 weeks)
* With pain during pre-inclusion care at least ≥3 to the Visual Analog Scale
* Person with cognitive and sensory capacities adapted to Virtual Reality (pre-inclusion verification on a device test of 5 to 10 minutes)
* Person affiliated or beneficiary of a social security scheme

Exclusion Criteria:

* Carriers of a wound located on the face or end of the head and interfering with the proper use of the Virtual Reality mask
* Visually impaired and / or hard of hearing impacting the correct use of the Virtual Reality mask (test of 5 to 10 minutes of the device during the pre-inclusion visit)
* Patient not fluent in French.
* Current diagnosis of epilepsy, dementia or other neurological diseases preventing the use of Virtual Reality hardware and software
* Patients under guardianship or curators
The Effect Of Mandala Activity On Postoperative Pain And Anxiety Levels In Gynecological Oncology Patients

This study was designed as a randomised controlled, 2-group, pre-test post-test comparative, experimental study to examine the effect of mandala activity on postoperative pain, anxiety levels and analgesia use of gynaecological oncology patients.

This study was designed as a randomised controlled, 2-group, pre-test post-test comparative, experimental study to examine the effect of mandala activity on postoperative pain, anxiety levels and analgesia use of gynaecological oncology patients.

The study was conducted with 42 patients who underwent open abdominal hysterectomy surgery in the Gynecological Oncology Surgery Clinic of a training and research hospital in Istanbul between 1 February 2023 and 1 August 2023. Patients in the intervention group (n=21) received mandala activity at least once a day during their postoperative hospitalisation (days 0-2). Patients in the control group (n=21) did not receive any intervention. Introductory Information Form, Visual Analogue Scale (VAS), State-Trait Anxiety Inventory (STAI-I), Postoperative Patient Evaluation Form and Mandala Activity Booklet were used in the study.

Eligibility Criteria:
Inclusion Criteria:

* Having a gynecological oncology disease diagnosis,
* Having had open abdominal hysterectomy surgery,
* Being over 18 years of age,
* Ability to communicate in Turkish,
* Having a gynecological oncology operation for the first time,
* There is no physical disability related to the upper extremities.

Exclusion Criteria:

* Readmission due to any complications that develop after discharge,
* Having visual, hearing and speech disabilities
Outcome After Radial Pressure Wave Therapy in Plantar Fasciitis.

The goal of this observational study is to explore potential associations between baseline patient characteristics (such as age, body mass index, and baseline pain intensity) and clinical outcomes in patients with plantar fasciitis undergoing radial pressure wave therapy (RPWT). The study includes male and female adults aged 18 to 60 years.

Background: Plantar fasciitis (PF) is a common cause of heel pain, significantly impairing functionality and quality of life. Radial pressure wave therapy (RPWT) has emerged as a non-invasive therapeutic option. However, there is limited evidence regarding factors that may influence clinical outcomes in patients receiving this treatment.

Objectives: The primary objective of this study is to explore potential associations between baseline patient characteristics (such as age, body mass index, and pain intensity) and clinical outcomes in patients with PF treated with RPWT. Additionally, this study aims to assess changes in pain intensity and functionality following RPWT.

Materials and Methods: This is an exploratory, pilot observational study including patients diagnosed with PF who undergo three sessions of RPWT. The study evaluates changes in pain intensity, assessed using the Numerical Pain Rating Scale (NPRS), and functionality, measured using the WHODAS 2.0. Patient characteristics such as age, body mass index (BMI), and PF chronicity are collected retrospectively from medical records. Statistical analyses will be conducted to examine potential associations between patient characteristics and treatment outcomes.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of plantar fasciitis confirmed by clinical evaluation.
* Age 18 to 60 years.
* Symptoms persisting for at least three months before treatment.
* Completed three RPWT sessions using a standardized protocol (2000 impulses per session, 10 Hz, and 3.5 bar).
* Availability of complete medical records, including three-month follow-up data.

Exclusion Criteria:

* History of foot surgery or corticosteroid injection in the affected limb within the past six months.
* Pregnancy at the time of treatment.
* Presence of concurrent musculoskeletal conditions (e.g., fractures, active infections, sprains) in the affected limb.
* Diagnosis of systemic conditions (e.g., cancer, osteoporosis, autoimmune diseases).
* Incomplete medical records or failure to complete RPWT sessions and follow-up visits.
Intranasal Ketamine for Anxiolysis in Pediatric Emergency Department Patients

Investigators plan to conduct a randomized, double-blinded, controlled study among pediatric patients requiring minor procedures in the Emergency Department setting. Patients will be randomized to one of two arms of intranasal treatments: ketamine 1.0 mg/kg (K) or midazolam 0.3 mg/kg (M). The primary outcome will be change in anxiety using the Modified Yale Preoperative Anxiety Scale (mYPAS).

The intranasal route of drug delivery is commonly used in Emergency Departments (ED) in pediatric patients. Multiple trials have shown the safety of administration of intranasal ketamine, including studies performed in the ED to treat pain in pediatric patients. The use of ketamine for anxiolysis has not been directly studied; however, ketamine has been shown to have anxiolytic effect at low doses as secondary outcomes when studied. Midazolam has been established as an effective medication to provide analgesia and anxiolysis. Investigators plan to conduct a randomized, double-blinded, controlled study in the Emergency Department. Pediatric patients presenting to the ED with the need for minor procedures who meet the inclusion and exclusion criteria will be consented, and if amenable, will be enrolled. Patients will be randomized to one of two arms of intranasal treatments: ketamine 1.0 mg/kg (K) or midazolam 0.3 mg/kg (M). Patients will be tracked for symptom improvement within the Emergency Department. The primary outcome will be change in anxiety from initial measurement to measurement 5 minutes pre-procedure using the Modified Yale Preoperative Anxiety Scale (mYPAS). Secondary outcomes will include sedation level, adverse events, need for additional medications, change in pain rating, patient and/or parent/guardian satisfaction.

Eligibility Criteria:
Inclusion Criteria:

* Patients age 2 to 12 years who present to the ED
* Requiring intravenous access
* Requiring laceration repairs
* Requiring incision and drainage of abscesses
* Requiring digital nerve blocks
* Requiring radiological imaging
* Requiring bladder catheterization
* Requiring foreign body removal.

Exclusion Criteria:

* Vital sign abnormalities greater than 20% deviation from age-normalized ranges
* Altered mental status/delirium or intoxication
* Patient or patient's parent/guardian are unwilling to participate or provide informed consent
* Any allergy to ketamine or midazolam
* Patient is female with history of menarche
* Presence of chronic oxygen-dependent pulmonary disease, liver cirrhosis, or renal disease requiring dialysis
* Presence of ischemic heart disease, heart failure, or a history of unstable dysrhythmias
* Presence of intracranial mass or vascular lesion.
* Presence of a history of psychosis or hallucinations
* Weight greater than 100kg
* History of increased intracranial pressure/ hypertensive hydrocephalus within the last 3 months
* Non-English speaking/reading parent/guardian and/or patients
* Patient is acutely psychotic
* Provider feels that patient currently or likely will require chemical and/or physical restraints
* History of prolonged QT-interval
* Nasal trauma
* Epistaxis
Maintenance Effect of Clobex Shampoo on Participants With Moderate to Severe Scalp Psoriasis

The objective of the study was to assess the maintenance effect on scalp psoriasis of Clobex® Shampoo 0.05% when used twice weekly.

Psoriasis was a chronic disease that was affecting skin, the scalp and joints. Scalp psoriasis was very common and was having an important impact on people's life.

Primary objective of scalp psoriasis treatments was to gain initial and rapid control of the disease process with a minimum of side-effects and improve patient quality of life.

Still, one of the unmet needs of scalp psoriasis therapies was the maintenance of a long-term remission. For corticosteroids in particular, one of the drawbacks was the disease recurrences after cessation of the treatment.

Therefore, the establishment of a modified corticosteroid dosing regimen that would allow remission with minimal side-effects was suitable.

The purpose of this study was to assess how long a patient successfully maintained in a good condition after use of Clobex® shampoo only twice a week.

Eligibility Criteria:
Inclusion Criteria:

* Male or female subjects aged 18 years or older.
* Subjects with moderate to severe scalp psoriasis

Exclusion Criteria:

* Subjects who needed systemic treatment for their body psoriasis
* Subjects with a washout period for topical treatment(s) on the scalp less than:

  * Corticosteroids 2 weeks
  * All other anti-psoriasis medications 2 weeks
* Subjects with a washout period for systemic treatment(s) less than:

  * PUVA therapy 4 weeks
  * Biological therapies 12 weeks
  * Treatments other than biologicals with a possible efficacy on psoriasis 4 weeks
  * Treatment known to worsen psoriasis 2 weeks
Prebiotic EffecT InfanTs

The study aims to confirm the effectiveness of chicory-derived prebiotic inulin-type fructans on stool consistency in infants.

The fermentation of prebiotic inulin-type fructans leads to a modulation of the gut microbiota composition, in particular to a growth stimulation of bifidobacteria, and the production of organic acids like lactate and short-chain fatty acids (SCFA). The introduction of solid foods is frequently associated with harder stools which are more difficult to pass and can cause painful defecations. Subsequently, the changes in bowel habits associated with weaning and the introduction of complementary foods could be minimized by the addition of prebiotics to complementary foods and, thus, the transition from milk-feeding to family food could be facilitated.

Eligibility Criteria:
Inclusion Criteria:

* Child is healthy at the time of pre-examination
* Child was born on term or preterm (≥ 32 weeks of gestation)
* Child is aged 6-12 months at the time of pre-examination (for preterm born children (32-37 weeks of gestation), corrected age will be applied)
* Normal growth (weight and length for age between 10th and 90th percentiles, Fenton and Kim 2013)
* Child receives at least one meal per day as complementary feeding
* Child and legal guardian are able and willing to follow the study instructions
* Child is suitable for participation in the study according to the investigator/physician/study personnel
* Written informed consent is given by parent or legal guardian

Exclusion Criteria:

* No legal guardian's command of any local language
* Organic causes of defecation disorders incl. Hirschsprung disease, Spina bifida, hypothyroidism etc.
* Other metabolic or renal abnormalities or psychomotor retardation (e.g. hypotonia)
* Child has allergy to cow's milk protein or lactose intolerance
* Child has been or is currently breast-fed more than once daily (6 weeks before intervention)
* Child has mostly loose or watery stools in ≥ 50% of defecations
* Use of drugs (e.g. antibiotics) influencing gastrointestinal function (6 weeks before intervention)
* Use of laxatives or pre- or probiotic supplements in the previous 4 weeks before intervention
* Child is currently involved or will be involved in another clinical or food study