cyrilzakka/clinical-trials huggingface dataset:
Preventing Disordered Eating and Body Dissatisfaction Among High-risk Pregnant Individuals

The investigators aim to conduct a feasibility randomized controlled trial (RCT) of an eating disorder prevention program (The Body Project, adapted for pregnancy) versus a health education control among pregnant individuals with histories of an ED. The investigators will test the feasibility, implementation outcomes, and its preliminary effectiveness in reducing the risk of elevated disordered eating and body dissatisfaction during pregnancy and postpartum.

The investigators aim to conduct a feasibility randomized controlled trial (RCT) of an eating disorder prevention program (The Body Project, adapted for pregnancy) versus a health education control among pregnant individuals with histories of an ED. The investigators will test the feasibility, implementation outcomes, and its preliminary effectiveness in reducing the risk of elevated disordered eating and body dissatisfaction during pregnancy and postpartum.

The investigators will aim to recruit N=60 pregnant individuals (in their first or second trimester) with histories of an ED. Both the intervention and active control consist of 6, weekly, 1-hour group sessions (6-8 participants per group) delivered over Zoom. There are four assessment points: pre-intervention, post-intervention, 3 months postpartum, and 6 months postpartum. Participants will complete online surveys at each assessment point and a post-intervention exit interview (active intervention only).

Eligibility Criteria:
Inclusion Criteria:

1. Within the first or second trimester of pregnancy at enrollment
2. 18 years or older
3. Able to provide informed consent
4. Endorse a self-reported history of an eating disorder or disordered eating behaviors
5. Are willing and able to comply with all group and study procedures
6. English fluency and literacy

Exclusion Criteria:

1. A diagnosis of bipolar or psychotic disorder, active mania or psychosis or substance abuse, an active eating disorder (active eating disorder symptomology informed by the Screening, Brief Intervention, and Referral to Treatment for Eating Disorders (SBIRT-ED) tool and clinician discretion), being at immediate risk of self-harm
2. Do not have access to a device with a camera
A Perianal Abscess Cavity Packing vs no Packing.

This prospective randomized trial will be conducted in all patients undergoing packing or no packing for perianal abscess cavity after incision and drainage, for 6 months after approval from IRB in Surgical unit III, Civil Hospital Karachi. Patient will be selected simple random sampling technique based on inclusion criteria. Patient will be assessed for post-operative pain, healing of cavity and recurrence of abscess. At first time of debridement pus or tissue will be sent for culture and sensitivity, meanwhile broad-spectrum antibiotic will be started.

Questionnaire will be filled by PI for post-operative pain, recurrence of abscess, quality of life, wound healing, post operative fistula in ano and chronic post surgical pain either due to packing or no packing.

This is an experimental randomized control trial will start 6 months after approval from Institution Review Board. All patients with perianal abscess after incision and drainage cavity will be either packed or not after informed consent. Pack will be changed daily as regular dressing till healing occurs. Packing reduces bleeding and heals cavity by effect of dressing solution in which gauze is soaked. Other group with dressing will be changed daily and will be assessed for healing week. There is no pain in simple dressing applied over cavity. Patient will receive broad spectrum antibiotics according to pus or tissue culture. During this period, laboratory investigation CBC, CRP will be sent to check the response. Sits bath will be advised to both groups. Post-operative pain, cavity healing will be assessed by faculty.

Eligibility Criteria:
Inclusion Criteria:

* Age greater than 18 years
* Age less than 70 years
* Perianal abscess

Exclusion Criteria:

* Suspected inflammatory bowel disease
* Fournier's gangrene
* Horseshoe/bilateral abscess
A Comparison of the Effect of Olmesartan Medoxomil, Losartan Potassium, and Atenolol on the Ability of Overweight Patients With High Blood Pressure to Respond to Insulin

To examine the effect of three different blood pressure medications on the insulin sensitivity in overweight patients with high blood pressure.


Eligibility Criteria:
Inclusion Criteria:

* Patients between the ages of 18 and 75 years (inclusive)
* Willingness to undergo insulin clamp procedure twice
* Overweight or obese (BMI=25-39 kg/m2)
* Subject must meet one of the following two blood pressure criteria at week-2 and at week-1: Systolic blood pressure 140-179 mmHg and diastolic blood pressure 85-99 mmHg OR Systolic blood pressure \< 140 mmHg and diastolic blood pressure 90-99 mmHg
* If female, must have negative serum pregnancy test at screening and be either post-menopausal, had a hysterectomy or tubal ligation at least 6 months before consent or if of childbearing potential, must practice approved measures of birth control throughout study

Exclusion Criteria:

* Systolic blood pressure \> 179 mmHg
* Diastolic blood pressure \> 99 mmHg or \< 85 mmHg
* Diagnosis of diabetes mellitus
* History of myocardial infraction, percutaneous transluminal coronary revascularization, coronary artery bypass graft, unstable angina pectoris or an episode of heart failure requiring hospitalization
* Previous history of a cerebrovascular accident or a transient ischemic attack
* History of allergic response to atenolol, losartan potassium, olmesartan medoxomil or any of their components
* Any serious disorder, including pulmonary, hepatic, renal, gastrointestinal (including clinically significant malabsorption), uncontrolled endocrine/metabolic, hematologic/oncologic (within the last 5 years), neurologic, and psychiatric diseases, that would interfere with the conduct of the study or interpretation of the data
* Laboratory abnormalities that could compromise subject safety
Study of Clostridioides Difficile in Infants

Clostridioides difficile infection (CDI) poses an increasing threat to infant and young child health, with detection rates rising annually. This retrospective study aims to explore the epidemiological characteristics, clinical manifestations, and potential biomarkers of CDI in children aged 0-2 years by examining three cohorts: (1) infants diagnosed with CDI, (2) asymptomatic carriers of C. difficile, and (3) healthy controls. Fecal samples from each group will undergo metagenomic sequencing and metabolomic profiling, coupled with questionnaire-based surveys for risk factor assessment. The findings are anticipated to identify key high-risk factors, elucidate the pathogenic mechanisms underlying infant CDI, and support the development of early diagnostic tools and preventive strategies.


Eligibility Criteria:
Inclusion Criteria:

1. Age Range: Infants aged 0 to 2 years (inclusive) at the time of sample collection or medical record documentation.
2. Data Availability: Complete medical records or available stool samples within the study's retrospective time frame.
3. Group-Specific Criteria:

   CDI Patients: Documented diarrhea or related gastrointestinal symptoms, with laboratory-confirmed C. difficile by PCR or culture.

   Asymptomatic Carriers: Positive C. difficile test (PCR or culture) in the absence of diarrhea or other clinical CDI symptoms.

   Healthy Controls: Negative C. difficile test and no gastrointestinal symptoms indicative of CDI.
4. Consent/Authorization:Retrospective data (e.g., existing medical records or stored biosamples) may be included under a waiver of consent if approved by the institutional review board (IRB). However, any new information obtained directly from participants or their guardians (e.g., via questionnaires) requires explicit informed consent.

Exclusion Criteria:

1. Incomplete Data: Infants whose medical records lack sufficient information to confirm their CDI status or those without adequate stool sample results.
2. Ambiguous Diagnosis: Patients presenting with other infectious diseases or conditions that could not rule out alternative diagnoses for diarrhea (e.g., confirmed concurrent viral or parasitic infections) without conclusive C. difficile testing.
3. Severe Comorbidities: Infants with life-threatening congenital conditions (e.g., severe immunodeficiency syndromes) if these conditions significantly alter the gut microbiota or confound CDI diagnosis.
Phase 2 Study of ALN-RSV01 in Lung Transplant Patients Infected With Respiratory Syncytial Virus (RSV)

To evaluate the safety,tolerability and antiviral activitity of ALN-RSV01 in RSV infected lung transplant patients


Eligibility Criteria:
Inclusion Criteria:

* Single or bilateral lung transplant recipients
* Confirmed RSV infection
* Greater than 90 days post current lung transplant
* Rejection free for a minimum of 1 month

Exclusion Criteria:

* Antimicrobial therapy for known viral, bacterial, or fungal respiratory co-infection at the time of diagnosis
* Bronchiolitis obliterans syndrome (BOS) Grade 3 or any state BOS with FEV1 that has not been stable for at least 3 months
* Use of alemtuzumab within 9 months prior to screening; anti-thymocyte globulin(ATG) or thymoglobulin within 3 months of screening: concurrent use of \>= 0.3 mg/kg/day prednisone or equivalent as maintenance therapy
* active treament for acute graft rejection
Descemet Stripping (Automated) Endothelial Keratoplasty (DSEK or DSAEK)

To evaluate the transplantation of a posterior corneal disc for the management of corneal endothelial disorders in Descemet Stripping Endothelial Keratoplasty (DSEK) or Descemet Stripping Automated Endothelial Keratoplasty (DSAEK).

Please see above.

Eligibility Criteria:
Inclusion Criteria:

* Corneal endothelial disorders

Exclusion Criteria:

* N/A
Facilitating Access to Specialty Treatment

The goal of this hybrid implementation-effectiveness study is to evaluate the effectiveness (hastened recovery times) and feasibility (fidelity in connecting to concussion specialty care) of a novel mobile health intervention, designed to reduce disparities in access to specialty care through the use of remote patient monitoring (RPM) to facilitate care hand-off from the emergency department (ED) to concussion specialty care. Participants will report their symptoms and activity once daily through RPM chat technology that is linked to their electronic health record and prompts referral to specialty care.


Eligibility Criteria:
Inclusion Criteria for concussed subjects:

* Males and females age 13 - 18
* Present to the Children's Hospital of Philadelphia (CHOP) Emergency Department (ED) within 72 hours of head injury
* Meet criteria for concussion as defined by the most recent International Consensus Statement on Concussion
* Own a smartphone
* Meet criteria for moderate-to-high risk for Persistent Post-Concussion Symptoms according to 5P rule (score \>3/12)

Exclusion Criteria for concussed subjects:

* Glasgow Coma Scale score \<13
* Lower extremity trauma
* A prior concussion within 1 month
* Non-English speaking
* Admission to the hospital at the initial head injury visit
* Previously enrolled in the study
* Inability to complete study procedures.

Inclusion Criteria for parents:

* Child meets the study eligibility criteria

Exclusion Criteria for parents:

* Non-English speaking

Inclusion Criteria for providers:

* ED or specialty provider caring for at least one patient via the mobile Health (mHealth)-facilitated care handoff strategy

Exclusion Criteria for providers:

* Non-English speaking
Evaluation of Ultrasonic Neuroma Size With Residual Limb Pain in Above-Knee Amputees

Background: The formation of neuromas, a fusiform swelling of a nerve or nerve ending, is a well documented response to limb amputation. Likewise, Residual Limb Pain (RLP), pain felt from the remaining portion of the amputated limb, is common among amputees. Neuromas are found in more than 90% of lower extremity amputations, of which 30-50% are pain-generating for the patient . And while surgical techniques reveal the commonly held belief that neuroma formation is one of the causal drivers behind RLP, there has been no study to demonstrate that the two events - namely the magnitude of neuroma formation and the magnitude of pain experienced by amputees - are correlated. If this correlation, or lack thereof, were elucidated with the use of ultrasonography, this would provide the preliminary data which could lead to further studies in neuroma minimization and/or proliferation.

Objective: This study seeks to use ultrasonography (US) to quantify the degree to which neuroma size and the nature of surrounding tissue correlate with the experience of RLP in trans-femoral amputees.

Setting and Subjects: This study will enroll 30 trans-femoral amputees, male and female, who are over the age of 18. The study will take place in the OHSU Orthopaedic Outpatient Clinic, and OHSU Imaging Department.

Intervention: None. This is an observational clinical study in which we will characterize the sciatic nerve/neuroma and surrounding tissue using ultrasound.

Measurements: We will use US to measure the cross sectional area of the neuroma at its widest point and compare this to the cross section of the same neuron at the lesser trochanter. Furthermore, we will describe the morphology of the neuroma. To quantify the subject's pain experience we will utilize the Questionnaire for Persons with Transfemoral Amputation (Q-TFA), Trinity Amputation \& Prosthetic Experience Scale (TAPES), Visual Analog Scale (VAS), and the Short Form 36 (SF-36).

Analysis: The statistical analysis will employ a Pearson correlation coefficient and linear regression analysis.


Eligibility Criteria:
Inclusion Criteria:

* greater than 18 years old
* a trans-femoral amputee
* more than one year post-amputation
* has worn a prosthesis within the last year

Exclusion Criteria:

* subject also diagnosed with diabetes
* subject also diagnosed with Peripheral Vascular Disease
* subject also diagnosed with peripheral neuropathy
* subject with spinal cord, head, or nerve root injury
Efficacy and Safety Study of Fibrin Sealant With 4 IU/mL Thrombin, Vapor Heated, Solvent Detergent Treated (FS VH S/D 4) in Face-Lift Procedures

The primary objective of this study is to evaluate the efficacy and safety of fibrin sealant with 4 IU/mL thrombin, vapor heated, solvent detergent treated (FS VH S/D 4) when used to reduce early postoperative bruising in participants undergoing a rhytidectomy (face-lift).


Eligibility Criteria:
Inclusion Criteria:

* Subjects planned for facial rhytidectomy
* Subjects who read, understand and sign the written informed consent
* Healthy female or male subjects as determined by the investigator using standard pre-operative assessments to include laboratory tests and ECG
* Subjects 18-75 years old, inclusively
* Subjects who are able and willing to comply with the protocol requirements
* Female subjects of childbearing potential with a negative urine or serum pregnancy test within 72 hours of surgery

Exclusion Criteria:

* Pregnant or lactating women
* Subjects who have undergone previous face-lift surgery
* Subjects undergoing abbreviated face-lift procedures such as deep plane procedures, minimal undermining procedures, thread lifts, and minimal access cranial suspension
* Subjects indicated for concurrent facial surgeries during the operation (e.g. forehead plasty, blepharoplasty, rhinoplasty, buccal fat removal, any filler injections including fat injections, lip augmentation, skin resurfacing procedures etc.)
* Subjects indicated for additional procedures during the same operation (e.g., liposuction, mastoplasty etc.)
* Subjects who had prior silicone injections to their face (Botox and/or Restylane are allowed)
* Subjects considered by the investigator to be smokers
* Subjects with ecchymosis and/or edema on the face on day 0, prior to surgery
* Subjects with known (documented) bleeding or coagulation disorders
* Subjects currently being treated with anti-coagulants
* Subjects treated with Aspirin in the last 7 days or use of other Non-steroidal anti-inflammatory drug (NSAIDs) within the last 7 days prior to surgery
* Subjects with vascular disorders, cardiovascular disease, and/or uncontrolled hypertension
* Subjects with diabetes mellitus
* Subjects with a history of Bell´s palsy
* Subjects with connective tissue disorders
* Subjects with documented history of pathologically or pharmacologically induced immune deficiency
* Subjects receiving systemic corticosteroid treatment for a chronic condition within 2 to 30 days prior to the surgery
* Subjects with a known sensitivity to fibrin sealants
* Subjects with a known psychiatric disorder (e.g., depression, obsessive compulsive disorder, anxiety, eating disorders, etc)
* Subjects who have participated in another clinical study within 30 days prior to this study
Evaluation of Homecare Reablement, the Trondheim Model

The aim is to evaluate a model of home-based rehabilitation. The intervention targets elder persons who receive homecare services, but still are relatively independent in most activities of daily living. The model focuses on early identification of decline in function and intervention in the home environment through close cooperation between the participant, homecare services and therapists.


Eligibility Criteria:
Inclusion Criteria:

* receive homecare services
* live within the catchment area

Exclusion Criteria:

* In-patient length of stay (IPLOS) score \> 2.0
* severe dementia
Observational Study on the Clinical Impact of Desaturation During Liver Surgery

The purpose of this study is to determine the clinical impact of cerebral and systemic desaturation during liver transplantation and resection on post-operative complications.

This is an observational study. Cerebral and systemic oxymetry (rSO2) using near infrared spectroscopy (NIRS, Invos 5100; Somanet- ics Corporation, Troy, MI) will be performed on all patients with 4 optodes (right and left temporal area, arm and leg). Continuous rSO2 values will be stored on a hard disk with a 15 seconds update within intraoperative period and first 4 hours after the surgery. Desaturation phases (saturation decrease more than 20% of the basal value for more than 15 seconds) will be correlated to operative procedure or events. Postoperative adverse events will be collected. A correlation between desaturation and postoperative adverse events will be done with a multiple linear regression model.

Eligibility Criteria:
Inclusion Criteria:

* patients undergoing an hepatic resection or hepatic transplantation
* patients able to give consent with knowledge of french or english language.

Exclusion Criteria:

* age\< 18 years
* patients with cerebral diseases
Taste and Local Tolerance Study of NLA Nasal Spray in Patients With Allergic Rhinitis

Evaluation of NLA Nasal Spray with regard to taste perversion and local tolerance

Oral or intranasal antihistamines is the first line treatment for allergic rhinitis. Cetirizine is a second-generation selective antihistamine widely used in an oral formulation for the treatment of allergic rhinitis. Local administration of cetirizine has been shown to reduce symptoms after allergen challenge, and has the potential to shorten the time to onset and decrease systemic side effects. However, local irritation and nasal burning/pain has been reported after nasal administration. For the compliance of the patients taking a nasal spray, the taste and tolerance of the product is of particular importance. NLA Nasal Spray contains cetirizine in a liposomal formulation aiming to improve the tolerability. The present study aims to compare the NLA Nasal Spray with cetirizine in an aqueous formulation and placebo with regard to taste perversion and local tolerance. This will be investigated off-season in patients with seasonal allergic rhinitis after provocation with allergen.

Eligibility Criteria:
Inclusion Criteria:

* 18 to 50 years of age (inclusive)
* Body Mass Index (BMI) between 18 and 28 kg/m2
* History of pollen-induced seasonal allergic rhinitis for at least two years and otherwise healthy
* Elevated specific IgE to at least one aero allergen or at least one positive skin pick test (SPT)
* Seasonal allergic rhinitis with symptoms provoked by the allergen with a corresponding elevated specific IgE or positive SPT
* Signed written Informed Consent

Exclusion Criteria:

* Perennial allergic rhinitis except for cat and/or dog sensitivity under the condition that these patients are not exposed to cats and dogs
* Soy bean allergy
* Peanut allergy
* Smoking during the last month before study inclusion
* Any upper respiratory tract infection during the period of 2 weeks before the start of the study
* Chronic medication
* Any medication, including herbal medicines, during their last five half-lives (t½)
* Nasal anatomical deviations
* Extensive use of nasal sprays as judged by the Investigator
* Ongoing nasal symptoms as judged by the Investigator
* Known hypersensitivity to cetirizine
* Pregnant or breast-feeding women
* Fertile women not using reliable methods of contraception (i.e. IUD, barrier method, hormonal contraceptives, abstinence)
* Participation in any other investigational study in the last three months
* Inability to adhere to the study plan
* Previous inclusion in this study
* Blood donation during the last three months
Expanded PK and PD of Insulin Glulisine Versus Insulin Aspart in Healthy Volunteers

The purpose of this study was to compare the pharmacodynamics (course of the blood glucose-lowering effect and duration of effect) and pharmacokinetics (course of the concentration of study medication in the blood) of a single subcutaneous dose of 0.2 units/kg of insulin glulisine and insulin aspart in a direct head-to-head comparison during two euglycemic glucose clamps in healthy subjects.

In a previous glucose clamp study with a head-to-head comparison of insulin glulisine and insulin lispro it was shown that the onset of metabolic action was significantly shorter with insulin glulisine than with insulin lispro (while the total metabolic effect was not different). These results were in line with a faster early insulin exposure of insulin glulisine compared to insulin lispro. The primary aim of this study was to investigate whether or not these favorable characteristics of insulin glulisine were also evident in the comparison against insulin aspart. This was the first clinical study realizing a head-to-head comparison between these two insulin analogs.

Eligibility Criteria:
Inclusion Criteria:

* Overtly healthy males or females (Women: contraception, Pearl Index \<1%)
* Between the ages of 18 and 65 years
* Body Mass Index of \<= 27 kg/m²
* Safety lab within reference range
* Normal blood pressure and heart rate
* Sufficient venous access
* Written informed consent approved by the Ethical Review Board
* HbA1c and fasting plasma glucose in the normal range

Exclusion Criteria:

* Investigative site personnel directly affiliated with this study and their immediate families or the sponsor´s employees
* Within 30 days of the initial dose of study drug had received treatment with a drug that had not received regulatory approval
* Known allergies to insulin or related compounds
* Regular treatment with any drug, both over-the-counter or prescribed
* an abnormality in the 12-lead ECG increasing the risk for participation
* History or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs
* Significant active neuropsychiatric disease
* Regular use of drugs of abuse and or positive findings on urinary drug screening
* Evidence of HIV and/or positive antibodies 1 or 2 and or HIV1 antigen
* Evidence of hepatitis B and/or positive hepatitis C antibody
* Evidence of hepatitis B and/or positive hepatitis B surface antigen
* Women with a positive pregnancy test or breastfeeding women
* Blood donation more than 500 mL within the last 3 months