cyrilzakka/clinical-trials huggingface dataset:
Pilot Study of PRX-03140 to Assess Safety for Use in Adult Subjects With Post Traumatic Stress Disorder

This is a clinical study for adult subjects with Post Traumatic Stress Disorder.

Open label clinical study to evaluate the efficacy of PRX-03140 in reducing PTSD symptoms

Eligibility Criteria:
Inclusion Criteria:

1. Male and female subjects between ages 18-55
2. The subject has signed and dated the written informed consent to participate in the study
3. The subject is able to understand and comply with written and verbal protocol requirements, instructions, and protocol-stated restrictions
4. The subject meets criteria for PTSD as defined by the DSM-IV-TR
5. Stable use of clinically prescribed medications
6. Subject able to complete baseline, 4 weeks, and 12 week psychological and cognitive evaluation
7. Female subjects - not surgically sterile (hysterectomy, bilateral oophorectomy, or bilateral tubal ligation) for at least 6 months or at least 2 years postmenopausal - must agree to utilize one of the following forms of contraception, if sexually active with a male partner, from screening through completion of the study. Approved forms of contraception are abstinence, hormonal (oral, implant, transdermal, vaginal, or injection) in use at least 3 consecutive months prior to the first dose of study medication, double barrier (condom with spermicide; diaphragm with spermicide), intrauterine device (IUD), or vasectomized partner (6 months minimum since vasectomy).

Exclusion Criteria:

1. Actively alcohol or drug dependent as defined by DSM-IV-TR Criteria
2. Patient actively suicidal within last 12-months or with current suicidal ideation
3. History of schizophrenia, bipolar disorder, attention deficit hyperactivity disorder, learning disability, stroke, multiple sclerosis or seizure disorder by interview
4. Participation in a clinical drug research study within the past 30 days
5. Subject currently taking any SSRI or anti-depressant medication.
6. Pregnant or breastfeeding females
7. Subjects will be excluded based on lab values, ECG findings, or physical findings that the Investigators deems exclusionary.
Novel Strategies for Reducing Burn Scar Itch

The purpose of the study is to see whether using diphenhydramine (Benadryl), famotidine (Pepcid), and cromolyn sodium will decrease burn scar itch.

The purpose of this study is to examine the effect of a new approach to treating burn scar itch. In other patient populations experiencing itch, H2 antihistamines and/or topically applied cromolyn sodium have decreased itch. We believe that these medications will reduce itch from burn scars. To test this idea, we will compare two methods of treating itch: 1) recommended oral diphenhydramine (Benadryl) with placebo capsule and placebo lotion and 2) recommended oral diphenhydramine (Benadryl) with administration of oral famotidine (Pepcid) and topically applied cromolyn sodium.

Eligibility Criteria:
Inclusion Criteria:

Participants must meet all the inclusion criteria in order to be eligible to participate in the study.

* Participant has provided informed consent in a manner approved by the IRB and is willing and able to comply with the trial procedures.
* Adults: ≥18 to \<80 years of age.
* Has an itchy burn scar.

Exclusion Criteria:

Participants meeting any of the exclusion criteria at baseline will be excluded from study participation.

* Failure to obtain consent or unable to return for follow up assessments.
* Patient is unable to follow the protocol required assessments.
* Member of a vulnerable class (e.g., prisoners, pregnant participant, etc.).
* Any medical condition that, in the opinion of the investigator or physician, would place the participant at increased risk for participation.
* Concurrent participation in another interventional clinical trial (to avoid confounding factors that may influence outcomes).
* History of prior non-compliance or the presence or history of psychiatric condition (including drug or alcohol addiction) that would, in the opinion of the investigator, make it difficult for the participant to comply with the study procedures or follow the investigators instructions.
* Age \< 18 or ≥ 80 years.
* Taking one of the following medications: cefuroxime, dasatinib, delavirdine, neratinib, pazopanib, risedronate, or tizanidine.
* Has a pre-existing inflammatory or itchy skin disease.
* Is taking an H2 antihistamine for another indication.
An Extension Study for Participants Who Have Completed the Treatment Period of a Qualifying Parent Study

The purpose of this research study is to evaluate the long-term safety, and tolerability of PF-06823859 study drug in adult participants with Dermatomyositis (DM) from a qualifying study.


Eligibility Criteria:
Inclusion Criteria:

* Participants aged ≥18 and ≤80 with moderate to severe dermatomyositis (DM), that have completed the treatment period of a qualifying study.
* Capable of giving signed informed consent.
* Participants who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures.

Exclusion Criteria:

* Other medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study
* Participants who met discontinuation criteria at any point during the participating qualifying studies.
* Participants with an ongoing safety event in the qualifying studies which, in the opinion of the investigator or sponsor, is an ongoing safety concern OR the participant has met safety monitoring criteria in the qualifying study that has not resolved.
Percutaneous Excision Trial

To confirm that a definitive diagnosis can be made from the tissue sample collected using the Intact BLES when defined radiology and pathology criteria are met.


Eligibility Criteria:
Inclusion Criteria:

* Patient must be a female at least 18 years of age at the time of Intact BLES biopsy
* Patient must have had an imaged abnormality found via mammography or sonography that warrants a biopsy for further diagnosis

Exclusion Criteria:

* Patients who have pre-pectoral breast implants
* Patients who have implantable devices such as pacemakers and defibrillators
* Patients who are pregnant or lactating
* Patients in whom the device is contraindicated
* Patients who are contraindicated for surgery due to factors such as anti-coagulant use which cannot be safely reversed or who exhibit fever or other clinical evidence of infection
Hormonal Stimulation in IUI Treatment: Is Clomifen Combined With Ethinyl Estradiol Better, Worse or Equal to Menopur

What is the best medication for hormonal stimulation in cycles with high intra-uterine insemination: tablets of Clomifen (5 days) followed by tablets of Ethinyl Estradiol (5 days) or daily injections with Human Menopausal Gonadotropin (Menopur)?


Eligibility Criteria:
Inclusion Criteria:

* women younger than 42 years old
* infertility of at least one year
* normal tubal, pelvic and uterine anatomy
* semen with total motility count of at least 5 million (at least one sample)

Exclusion Criteria:

* premature ovarian failure
* medical history of tubal or ovarian surgery
* tubal or pelvic adhesions
Child Health, Nutrition and Microbiome Development

Childhood malnutrition is a global public health issue with devastating consequences on the health, well-being, and psychosocial development of children. Emerging evidence suggests that malnourished children have immature gut microbiota compared to age-matched healthy controls and it does not repair even after nutritional interventions. The present study aims to characterize how the gut microbiome develops during the first two years of life in children residing in malnutrition endemic areas of Khyber Pakhtunkhwa, the region with the highest prevalence of childhood malnutrition in Pakistan and the region.

Malnutrition in children remains a global public health challenge. The consequences are often severe and deadly, particularly in low- and middle-income countries where malnutrition contributes to \~half of deaths in children under five years of age. Pakistan is among those nations with the highest burden of stunting (40.2%), wasting (17.7%), and micronutrient deficiency in children under five years of age. Recently, scientists discovered that the trillions of microbes (gut microbiome) that live in the human gut affect the nutritional status and overall health of children during the initial years of life. In this context, research studies from developing countries, where malnutrition is common, have reported an impaired or immature gut microbiome in malnourished (stunted, wasted, and underweight) children compared to matched healthy controls and it does not repair even after nutritional intervention. Therefore, a nutritional intervention strategy that does not take into account the gut microbiome microbiota will fail to ameliorate the long-term consequences of malnutrition.

In this prospective cohort study from Pakistan, healthy infants (n=70) aged 0 - 28 days will be recruited from rural and remote areas of District Swat and followed at 3, 6, 12, 18 and 24 months. Ante-natal and postnatal history, Dietary intake data, dietary diversity, Infant and young child feeding (IYCF practices), and Health outcomes data will be collected at baseline and followup. The investigators will also collect dry blood spot, stool and oral swab samples and conduct anthropometric assessments of both mother and the baby at each time point. Advanced, next-generation sequencing technology will be used to explore gut microbiome diversity and functional potential.

Eligibility Criteria:
Inclusion Criteria:

* Healthy infants aged 0 - 28 days
* Born to parents residing in rural and remote areas of District Swat
* Living in separate households
* Parents/caregivers have no plans to move out of the stud site for at least one year after enrollment in the study.

Exclusion Criteria:

* Child born to underage (\<18 years old) mother.
* Infants born with severe acute or chronic medication conditions that require hospitalization or prolonged use of medication or both or the infant is diagnosed with enteropathies.
* Whose parents refused to provide informed consent to participate in the study.
* Weight of the child is \<1500 gm.
Study of Buprenorphine HCl Buccal Film in the Treatment of Dental Pain

The purpose of this study is to assess the activity of buprenorphine hydrochloride (HCl) buccal film in the treatment of dental pain.


Eligibility Criteria:
Inclusion Criteria:

* extraction of 2 or more third molars, at least 1 of which must be fully or partially impacted in mandibular bone
* males or non-pregnant females, aged 18 to 45 years
* good general health and capable of providing informed consent

Exclusion Criteria:

* history of substance abuse or dependence
* positive urine toxicology screen or alcohol breath test
* history of hypersensitivity to or allergy to any study drug
* donation of blood within prior 30 days
* use of analgesics, caffeine, sedatives, antidepressants, anticoagulant or antiplatelet agents within 24 hours
Hydrocortisone for Term Hypotension

This trial will evaluate the effects of a 7-day course of hydrocortisone therapy on short-term morbidity, cardiovascular function, long-term neurodevelopment, and mortality in critically ill, term and late preterm infants diagnosed with cardiovascular insufficiency as defined by a need for inotrope therapy in the first 72 hours of age.

Cardiovascular insufficiency is common and potentially life-threatening in critically ill term and late preterm newborns admitted to the newborn intensive care unit (NICU) in the first few days of age.

This study proposes to conduct a multicenter, randomized, masked, placebo-controlled trial within the Neonatal Research Network (NRN). This trial will evaluate the effects of a 7-day course of hydrocortisone therapy on short-term morbidity, cardiovascular function, long-term neurodevelopment, and mortality in critically ill, term and late preterm infants diagnosed with cardiovascular insufficiency as defined by a need for inotrope therapy in the first 72 hours of age.

Eligibility Criteria:
Inclusion Criteria:

* Gestational age greater than or equal to 34 weeks at birth
* Admitted to the center NICU by 48 hours of age
* Intubated and mechanically ventilated for a minimum of 2 hours before 72 hours postnatal age

Exclusion Criteria:

* Receiving ECMO
* Intubated for the sole purpose of anticipated surgery or airway anomalies
* Treatment will be limited based on poor prognosis
* Receiving dexamethasone or hydrocortisone
* Receiving ibuprofen or indomethacin
* Congenital heart disease
* Hypotension thought to result from specific, immediately remediable factors including placental hemorrhage, acute hemorrhage or tension pneumothorax
* Pituitary hypoplasia or congenital adrenal hyperplasia
* Any chromosomal disorder
* Hypertension in the absence of inotrope therapy as defined by mean arterial blood pressure \> 95th percentile
* Initiation of whole body cooling for moderate or severe neonatal encephalopathy
* Brain disorders or any other known structural abnormality
* Major anomalies
Oocyte Vitrification Aided With Cytochalasin B

Using the cytoskeleton Stabilizer the Cytochalasin B would improve the outcome of oocyte vitrification.


Eligibility Criteria:
Inclusion Criteria:

* indication for oocyte vitrification

Exclusion Criteria:

-
Flexible Attention Sensory Training for Youth with Chronic Pain

The purpose of this study is to determine the feasibility and acceptability of gamified sensory rehabilitation training technology for children with chronic musculoskeletal pain.

The TrainPain devices allows patients with chronic pain to perform sensory rehabilitation training at home, in a gamified format. The system uses a temporary tactile discrimination task, which directly engages inhibitory functions of the somatosensory cortex. In this way, the game trains the brain's sensory system to be more precise. The technology's dual-probe system allows sensory stimuli to be delivered to multiple body locations, which trains patients to flexibly shift their attention towards and away from pain according to dynamic game-directed goals. The sensory training reduces hypervigilance towards painful body regions and enables flexible attention shifting to engage with daily goals. Last, the TrainPain system captures and quantifies performance over time, providing a breadth of intricate and precise data, thus allowing the research team to assess outcomes and mechanisms of training effects. In preliminary studies with adults, TrainPain is shown to be highly engaging, and effective at reducing pain in adults with widespread musculoskeletal (MSK) pain. The current pilot study intends to establish, for the first time, the feasibility and acceptability of using the TrainPain system among youth with chronic MSK pain.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of musculoskeletal pain including chronic regional pain syndrome
* English speaking

Exclusion Criteria:

* Diagnosis of neurological conditions such as seizures, cerebral palsy, developmental delay
* Severe affect disorders (e.g. severe depression/anxiety) from medical record review
* Chronic skin disease or topical allergies that would be worsened by the use of sensor tape
Prediction of BK Virus Reactivation in Kidney Transplant Recipient

There has been no effective predicting tool to accurately predict BKV reactivation after kidney transplantation. The aim is to elucidate the use of flow cytometric analysis for both intracellular cytokines and surface activation markers for BKV-specific T cell response in kidney transplant recipients.


Eligibility Criteria:
Inclusion criteria:

1. New kidney transplantation cases (either living donor or deceased donor transplantation)
2. Age ≥ 18 years old
3. Agree to give a permission to blood sampling post-transplantation, and at the time of BK viremia.

Exclusion criteria:

1. Pregnant
2. Primary non-function of kidney allograft (i.e. kidney allograft never function).
Pharmacokinetic Study of 48-hour Sevoflurane Inhalation Using a Disposable Delivery System (AnaConDa©) in ICU Patients With Acute Kidney Injury

Describing a pharmacokinetic model of 48-h sevoflurane sedation in ICU patients with acute kidney failure

Prospective clinical monocentric study in ICU with sedated ventilated patients (presenting acute kidney failure) with sevoflurane during 48 h with the AnaConda® system, establishing pharmacokinetic model of sevoflurane and its metabolites (hydroxyfluroisopropanol, fluoride)

Eligibility Criteria:
Inclusion Criteria:

- Adult patients ventilated more than 48 h Stable respiratory and hemodynamic conditions Consent of patients or family Arterial line AKIN score = 3

Exclusion Criteria:

* BMI \<30 Sevoflurane anaphylaxia
CHOCO-CABANA Trial

The study will be performed 120 patients at about 6 to 8 study centers. Only patients with clinical conditions requiring assessment of patency of the treated BTK lesions at 6 months post procedure by MRA as part of standard care to prevent amputations as consequence of non-detected re-stenosis/occlusions will be included in the study. The sequence in which the individual patients will be treated will be randomized with the Chocolate PTA balloon and the uncoated conventional PTA balloon at each center. 60 patients will be randomized to uncoated conventional PTA balloon treatment and 60 patients to treatment with the Chocolate PTA balloon.

All lesions in each patient (lesions that fulfill the inclusion/exclusion criteria) should be treated as the patient is randomized.

In patients with long lesions more than one balloon may be used. Overlapping of balloons (at least 10mm) is mandatory to avoid untreated gaps between sequential treatments. Follow up will be performed at 1 and 6 months.


Eligibility Criteria:
Inclusion Criteria:

1. \>18 years of age
2. Chronic stenotic or occlusive atherosclerotic disease of the infrapopliteal arteries
3. Patients with clinical conditions requiring assessment of vessel patency of treated BTK lesion 6 months post procedure as part of clinical standard of care to prevent amputa-tions as consequence of non-detected re-stenosis
4. BTK intervention with lesions between 1 and 25 cm
5. Sufficient outflow of the treated artery to the foot (less than 50% stenosis or sufficient collaterals)
6. All BTK lesions either to be treated with conventional PTA or with the Chocolate PTA balloon (if inclusion criteria 4 and 5 apply)\*

   \* The longest lesion will be taken as primary lesion. All other lesions will be also analyzed within the study protocol but separately evaluated. If a secondary lesion does not fulfill the inclusion criteria 4 and 5, the lesion can be treated upon the decision of the operator and will not be analyzed within the study protocol.
7. Rutherford 3-5 patients
8. Patients who are able to be followed to assess vessel patency according to standard lo-cal hospital care (e.g. DUS, MRA)
9. Successfully treated inflow lesions up to TASC B

Exclusion Criteria:

1. Acute or sub-acute thrombosis
2. In-stent restenosis
3. Rutherford 1-2 and 6
4. Patient who is not fit for follow-up (including contraindication for MRA)
5. Vessel preparation with cutting balloon, lithotripsie, atherectomy
Correlating Multispectral Near-Infrared Imaging to Standard Vascular Diagnostics

The goal of this observational study is to learn if the measures of tissue oxygenation from the MIMOSA Pro imaging device correlate to standard vascular assessment tools in patients who receiving a lower extremity vascular assessment.

The main questions it aims to answer are:

* Do the MIMOSA Pro tissue oxygenation measures correlate to Ankle-Brachial Index, Toe-Brachial Index, transcutaneous oximetry, and Doppler wave forms?
* Do the MIMOSA Pro tissue oxygenation measures correlate with disease classifications for peripheral arterial disease, venous disease, and wound stage?
* Is the MIMOSA Pro able to measure vascular status more often than other modalities?

Participants will be asked to follow standard of care, and also allow for their legs to imaged by the MIMOSA Pro.

Observational non-interventional study to assess the use of multispectral near-infrared (MS-NIR) imaging as an adjunct tool in the wound center. No clinical decisions will be made based on information obtained through the use of the MIMOSA device. Objectives are to correlate tissue oxygen saturation (StO2) by MS-NIR to measures by standard vascular diagnostic tools, including ankle-brachial index (ABI), toe-brachial index (TBI), transcutaneous oximetry, Doppler waveforms. Also to assess the ability of MS-NIR to support the classification and grading severity of patients' peripheral artery disease (PAD), venous disease and wound healing and to evaluate the clinical workflow utility of MS-NIR as an adjunct tool in the wound center. The study will recruit patients 18 years old and older, are undergoing an ankle-brachial index exam and recently had/will have further vascular assessment, as per standard of care (inc. transcutaneous oxygen pressure, Doppler waveforms). Participants will be asked to allow for imaging of their lower extremities with the MIMOSA Pro. Investigator will assess participants on their disease and wound status. They will also perform vascular assessments mentioned above as per standard of care. Participants will be followed for 2 months as per regularly scheduled visits. The standard vascular assessment results and disease/wound status will then be correlated with the measures from the MIMOSA Pro.

Eligibility Criteria:
Inclusion Criteria:

* Provision of signed and dated informed consent form
* Stated willingness to comply with all study procedures and availability for the duration of the study
* Male or female, aged 18 and older
* Patient is undergoing an ABI test.
* Patient recently had/will have further vascular assessment, as per standard of care (inc. transcutaneous oxygen pressure, Doppler waveforms)
* Patients who can be followed by the same investigating team for the whole period of their participation in the study.

Exclusion Criteria:

* Patients who are participating in another clinical study for ulcer management
* Patients who are unable to understand the aims of the study and not able to provide informed consent
* Receiving radiation to the extremity
* Active charcot joints