cyrilzakka/clinical-trials huggingface dataset:
Sharp Versus Blunt Uterine Incision Expansion

comparison between blunt versus sharp expansion of uterine incision at lower segment cesarean section in primigravida as regards the intra-operative blood loss \& postoperative pain

the study includes 200 pregnant women, primigravidas, at term who underwent elective transverse lower segment Cesarean section for the first time among the age group of 20 - 37 years with a singleton pregnancy.

The patients are divided randomly into two groups as follows:

* Group (A): undergoing blunt uterine incision expansion
* Group (B): undergoing sharp uterine incision expansion

Eligibility Criteria:
Inclusion Criteria:

* singleton pregnancy.

Exclusion Criteria:

* previous PID
* any medical or psychiatric
* patients with BMI ≥ 40
* multigravidas
* chronic analgesia use,
* allergy to analgesics,
* multiple pregnancies are also excluded
Inhaled Nitric Oxide to Prevent and Treat Bronchopulmonary Dysplasia

Inhaled nitric oxide in preterm babies with respiratory failure or ventilator dependence will:

1. decrease the incidence of Bronchopulmonary Dysplasia (BPD) or death
2. shorten the length of oxygen therapy and hospital stay ,reduce the cost of hospital stay without increasing adverse effect

Bronchopulmonary dysplasia remains a problem in neonatal intensive care unit (NICU) all over the world. This multicenter, non-randomized, unmasked clinical trial evaluate the efficacy of inhaled nitric oxide (iNO) in the treatment of the preterm infant with developing bronchopulmonary dysplasia.

Infants were followed until death or discharge to home. The trial will compare iNO therapy to conventional management strategies (including treatment with nasal continuous positive airway pressure (CPAP), surfactant and high frequency ventilation as adjuncts to iNO therapy) as the control.

During the initial dosing, iNO was started at 5 ppm and could be decreased to 1-2 ppm. The Infants would inhale NO until weaned. Infants will be monitored for signs of toxicity due to cumulated dosage of NO and its metabolites, such as methemoglobin, and nitrite and nitrate in blood and urine, and nitrogen dioxide in ventilator circuit to the patient.

Eligibility Criteria:
Inclusion Criteria:

* GA\<=34w,less than 7 days of age,oxygenation index (OI) of more than 10 after being ventilated for more than 48 hours or surfactant therapy
* GA\<=34w,between 7 to 30 days of age, requiring assisted ventilator or nasal continuous positive airway pressure for more than 2 days

Exclusion Criteria:

* lethal congenital anomalies or congenital heart disease (including an atrial septal defect larger than 1 cm and a ventricular septal defect larger than 2 mm)
* active pulmonary hemorrhage, unevaluated pneumothorax
* preexisting bilateral grade 3-4 intraventricular hemorrhage
* a platelet count \<100\*10\^9/l
* an expected duration of ventilation of less than 48 hours
The Effect of Dry Needling on Muscle Stiffness, Gait, Motion, and Strength in Healthy Individuals With Trigger Points

This study would be the first study to assess the immediate effects of dry needling of latent trigger points of the gastrocnemius muscle on muscle stiffness, gait, range of motion, and strength. The study has the potential to demonstrate that dry needling may have immediate effects on mechanical properties of muscle and may thus guide future treatment for individuals with changes in muscle tissue secondary to pain and/or injury.

Participants will complete the following tests: muscle stiffness testing in both a relaxed and contracted position, GAITRite for spatial and temporal gait characteristics, the Ankle Lunge Test (ALT) to assess range of motion, and calf strength using a dynamometer. Subjects will then receive treatment according to which group they are randomized. Muscle stiffness, gait, motion and strength will be reassessed immediately following treatment at the first session. Four to10 days later, participants will complete the same tests and measures prior to treatment being administered a second time. Another 4-10 days after the second session, participants will complete the tests and measures one final time.

Eligibility Criteria:
Inclusion Criteria:

1. Age 18-50 years
2. Able to read and speak sufficient English to complete consent form
3. Symmetrical gait pattern demonstrated through observation
4. Presence of latent trigger point in gastrocnemius muscle

Exclusion Criteria:

1. Any prior foot/ankle surgery, deformity, or injury on the which would affect strength of the gastrocnemius
2. Any prior acupuncture or dry needling within the past month
3. History of systemic disorder in which dry needling would be contraindicated (i.e. bleeding disorders or anticoagulant medication use)
4. Have fractures of the spine, hip, or knee that would likely affect their weight bearing or gait
5. Restrictions in plantar flexion range of motion which would inhibit performing a heel raise
6. No specific calf injury in the past 6 months
7. Participants known or thought to be pregnant
Rural Colon Cancer Screening Toolkit Intervention

Less than half of all positive fecal immunochemical testing (FIT)s are followed-up by colonoscopy, thus limiting the full potential of colorectal cancer (CRC) screening to reduce mortality. Given the need for coordination in order to achieve high rates of follow-up, multilevel approaches are needed. Such approaches could be particularly beneficial in communities and populations that experience cancer disparities and have fewer specialty providers, but most data focuses on large systems or urban areas. The academic-community health system collaboration is uniquely poised to address this research and service gap. The persistent poverty and health disparities in rural Southern Illinois set the stage for truly impactful research. The investigators' approach will serve as a model for multilevel interventions in rural settings, inform future work addressing other health disparities, and fill a gap in rigorous trials of CRC screening follow-up in rural areas.


Eligibility Criteria:
Inclusion Criteria for Primary Care Clinic Sites

* Physician Hospital Organization (PHO) affiliated with Southern Illinois Healthcare

Exclusion Criteria for Primary Care Clinic Sites

* Not a part of the PHO

Inclusion Criteria for Physicians and Staff at Primary Care Clinic Sites

* Employment at the relevant clinic at the time of the study

Exclusion Criteria for Physicians and Staff at Primary Care Clinic Sites

* Not employed at the relevant clinic at the time of the study

Inclusion Criteria for Patients

* Age 45-75 during the study period
* Must be patient of the selected primary care clinic sites

Exclusion Criteria for Patients

* Younger than 45 years of age or older than 75 years of age during the study period
* Not a patient of the selected primary care clinic sites

Inclusion Criteria for Community Members

* Age 45-75 at the time of the health fair or screening event
* Able to undergo stool testing as determined by SIH staff at the health fair or screening event

Exclusion Criteria for Community Members

* Younger than 45 years of age or older than 75 years of age
* Unable to undergo stool testing
A Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of Ivacaftor in Subjects With Cystic Fibrosis Who Are Less Than 24 Months of Age and Have an Ivacaftor-Responsive CFTR Mutation

The purpose of this study was to evaluate the safety of ivacaftor treatment, and PK of ivacaftor and metabolites in participants with cystic fibrosis (CF) who are \<24 months of age at treatment initiation and have an ivacaftor-responsive CF transmembrane conductance regulator (CFTR) gene mutation.


Eligibility Criteria:
Inclusion Criteria:

* Confirmed diagnosis of CF by sweat chloride value or CF mutation criteria.
* Have 1 of the following 10 CFTR mutations on at least 1 allele: G551D, G178R, S549N, S549R, G551S, G1244E, S1251N, S1255P, G1349D or R117H (eligible in regions where ivacaftor is approved for use). Part A/B group may also have other ivacaftor-responsive mutations.
* Hematology, serum chemistry, and vital signs results at screening with no clinically significant abnormalities that would interfere with the study assessments, as judged by the investigator.

Exclusion Criteria:

* History of any illness or condition that, in the opinion of the investigator, might confound the results of the study or pose an additional risk in administering study drug to the participant
* Colonization with organisms associated with a more rapid decline in pulmonary status at screening (Only for Parts A and B)
* History of abnormal liver function or abnormal liver function at screening
* History of solid organ or hematological transplantation
* Use of any moderate or strong inducers or inhibitors of cytochrome P450 (CYP) 3A within 2 weeks before Day 1
* Participation in a clinical study involving administration of either an investigational or a marketed drug within 30 days or 5 terminal half-lives before screening
* Hemoglobin (Hgb) \<9.5 g/dL at screening
* Chronic kidney disease of Stage 3 or above
* Presence of a non-congenital or progressive lens opacity or cataract at Screening

Other protocol defined Inclusion/Exclusion Criteria may apply.
Study of Obeldesivir as Postexposure Prophylaxis for Marburg Virus Disease

The goal of this clinical study is to learn more about the study drug, obeldesivir (ODV), and how safe and effective it is preventing Marburg virus disease (MVD) in participants with known or suspected exposure to Marburg virus (MARV).

The primary objective is to evaluate the safety and tolerability of ODV for MARV postexposure prophylaxis (PEP).


Eligibility Criteria:
Key Inclusion Criteria:

* Able to understand and give written informed consent and comply with treatment and follow up.
* Individuals who are of childbearing potential and engage in heterosexual intercourse must agree to use protocol-specified method(s) of contraception
* Known or suspected high-risk exposure to MARV within 21 days of Day 1. High-risk exposure may include the following:

  1. Direct contact with bodily fluids from a confirmed MVD case.
  2. Needle stick injury with a needle potentially contaminated with MARV.
  3. Prolonged exposure to an individual with MARV infection or MVD without (adequate) personal protective equipment.

Key Exclusion Criteria:

* Individuals with plans to breastfeed during the study period and 21 days following the last dose of study intervention. World Health Organization guidance on breastfeeding should be followed.
* Known hypersensitivity to the study intervention, its metabolites, or formulation excipient.
* Known MARV reverse transcriptase-polymerase chain reaction (RT-PCR) positivity or symptomatic MVD as attributed by the investigator.
* Known moderate or severe renal impairment or known estimated glomerular filtration rate (eGFR) \< 60 mL/min/1.73 m\^2.
* Decompensated cirrhosis (Child-Pugh Class C), acute liver injury/failure (eg, new onset \[\< 2 weeks\] of easy bruising, jaundice, ascites, hepatic encephalopathy, asterixis), and/or known alanine aminotransferase ≥5 × upper limit of normal.

Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Assessment of the Effects of Silk Pillowcases on Acne Prone Skin

The purpose of this study is to determine the effects of using silk pillowcases in mild to moderate non-cystic acne prone skin in comparison to cotton pillowcases.

The investigators will evaluate acne severity/ lesion count, trans-epidermal water loss, and sebum production in participants. There is an equal chance of being assigned a 100% silk pillowcase or 100% cotton pillowcase.

Eligibility Criteria:
Inclusion Criteria:

* Males and females between the ages of 15-45 years of age
* The presence of mild to moderate acne vulgaris based on investigator global assessment
* Presence of at least 5 inflammatory lesions and at least 5 non-inflammatory lesions

Exclusion Criteria:

* The presence of severe acne as noted by investigator global assessment.
* Those who are unwilling to discontinue systemic antibiotics and benzoyl peroxide for 4 weeks meet the washout criteria prior to enrolling.
* Those who are unwilling to keep their facial regimen consistent throughout the study, and for 1 month prior to enrolling.
* Individuals who are unwilling to wash pillowcase every week using provided detergent.
* Use of isotretinoin within the three months prior to enrolment
* Individuals who primarily sleep on their back
* Current tobacco smoker or a tobacco smoking history of greater than 10 pack year
* Individuals on oral contraceptive pills or progesterone or estrogen containing therapies.
* Individuals who have changed any of their hormonal based contraception within 3 months prior to joining the study
* Individuals with known allergy or sensitivity to Mulberry Silk or Cotton Fibers in fabric
Study to Evaluate the Efficacy and Safety of Oral Difelikefalin for Moderate to Severe Pruritus in Subjects With Notalgia Paresthetica

This is a 2-part, multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of twice-daily (BID) oral difelikefalin for moderate-to-severe pruritus in adult subjects with NP.

Part A of this study will evaluate the benefit-risk of 3 doses of difelikefalin compared to placebo. The dose with the best benefit-risk profile will be further evaluated in Part B. Part A of this study comprises a 28-day Screening Period, a 7-day Run-in Period, an 8-week Double-blind Treatment Period, a 2-week Treatment Discontinuation Period, and a Safety Follow-up Visit (14 days after the last dose of study treatment).

Part B of this study will evaluate the efficacy, safety, and tolerability of oral difelikefalin. The dose of oral difelikefalin to be assessed in Part B will depend on the results of Part A. Part B of this study comprises a 28-day Screening Period, a 7-day Run-in Period, an 8-week Double-blind Treatment Period, up to a 52-week OLE Period, and a Safety Follow-up Visit.

Subjects who participated in Part A of the study may not participate in Part B.

All subjects will sign an informed consent form (ICF) and undergo screening for study eligibility.

Eligibility Criteria:
Key Inclusion Criteria:

To be eligible for inclusion into the study, a patient must meet the following criteria:

* Subject has clinically confirmed diagnosis of active Notalgia Paresthetica;
* Subject has a history of chronic pruritus due to Notalgia Paresthetica;
* Subject has moderate to severe pruritus;
* Female subject is not pregnant or nursing during any period of the study.

Key Exclusion Criteria:

A patient will be excluded from the study if any of the following criteria are met:

* Subject has pruritus attributed to a cause other than Notalgia Paresthetica;
* Subject has any clinically significant medical condition or physical/laboratory/ECG/vital signs abnormality that would, in the opinion of the investigator, put the subject at undue risk or interfere with interpretation of study results.
Preoperative Micronized Flavonoid Fraction (MFF) Use in Multimodal Anesthesia in Anorectal Surgery

Aim: To assess the efficiency of the micro-flavonoid fraction (MMF) administration prior to anorectal surgery with spinal anesthesia on postoperative pain severity reduction.

Methods: Patients who meet the following criteria are included: participants must be diagnosed with surgical treatment of anorectal diseases. All participants are randomly divided into 2 groups: the first one gets a tablet with 1000 mg MFF (Detralex®), the second one gets a tablet containing starch per os 14 days before surgery (72 participants per arm). Then patients of each group will continue MFF administration for 30 days after surgery. Patients of both arms receive spinal anesthesia and undergo surgery. Following the procedure the primary and secondary outcomes are evaluated: frequency of the opioid drugs intake, the severity of the postoperative pain syndrome, duration and frequency of other drugs intake, readmission rate, overall quality of life, time from the procedure to returning to work and the complications rate, C-reactive protein level.

Discussion: the MFF intake allows reducing the severity of the hemorrhoidal disease symptoms during conservative treatment. In addition, the Detralex® efficacy has been proven in postoperative pain reduction for patients diagnosed with varicose veins of the lower extremities. The investigators intend to evaluate the feasibility of the preoperative MFF administration for the postoperative pain reduction and the decrease of the postoperative complications in patients with hemorrhoidal disease.


Eligibility Criteria:
Inclusion Criteria:

* Stage 2-4 hemorrhoidal disease;
* Presence of indications for elective surgery (open hemorrhoidectomy) using mono or bipolar coagulation possibly combined with other minimally invasive methods: hemorrhoidopexy and mucopexy, Ligasure hemorrhoidectomy;
* Absence of other diseases that cause pain;
* Class I, II ASA anesthesia risk;

Exclusion Criteria:

* The presence of the following diseases: paraproctitis, inflammatory bowel disease, metabolic or endocrine disorders, alcoholism, drug use, blood clotting disorders, and history of diseases in the anorectal region;
* Contraindicated or technically impossible subarachnoid anesthesia;
* Patients who refused to participate;
* Pregnant women.
Evaluation of Pharmacokinetics, Safety, and Preliminary Efficacy of Isatuximab in Chinese Patients With Relapsed and/or Refractory Multiple Myeloma

Primary Objective:

To evaluate the pharmacokinetics (PK) of isatuximab.

Secondary Objectives:

* To evaluate the safety and tolerability of isatuximab.
* To assess the preliminary antitumor effect of isatuximab.
* To evaluate the immunogenicity of isatuximab.

The duration of the study for an individual patient will include a screening period of up to 21 days, a treatment period of repeated 28-day cycles, and a follow-up period. End of treatment visit will be done at 30 (±7) days after last treatment.

Eligibility Criteria:
Inclusion criteria:

* Known diagnosis of symptomatic multiple myeloma.
* At least 2 prior lines of therapies which must include treatment with at least 1 of an immunomodulatory drug (IMiD) or a proteasome inhibitor (PI). The patients must have received an IMiD or a PI for ≥2 cycles or ≥2 months of treatment.
* Patients must have been responsive to at least 1 prior line of therapy (minimal response or better).
* Refractory to the most recently received IMiD or PI included therapy (ie, patients must have progressed during or within 60 days of completion of treatment with IMiD or PI). For patients who have received more than 1 type of IMiD or PI, their disease must be refractory to the most recent one.
* Measurable disease defined as at least 1 of the following:

  * Serum M-protein ≥0.5 g/dL (≥5 g/L);
  * Urine M-protein ≥200 mg/24 hours.
* Written informed consent.

Exclusion criteria:

* \<18 years old.
* Eastern Cooperative Oncology Group (ECOG) performance status \>2.
* Life expectancy of less than 3 months.
* Pretreated with any anticluster of differentiation (CD) 38 agent.
* Concurrent plasma cell leukemia.
* Known amyloidosis.
* Disease measurable only by serum free light chain (FLC) analysis.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
TVT-Secur Versus TVT-Obturator: A Randomized Trial of Suburethral Sling Operative Procedures

The purpose of this study is to determine whether TVT-Secur (TVT-S) (Hammock method) and TVT-Obturator (TVT-O) suburethral sling procedures have equivalent patient satisfaction and clinical efficacy in the treatment of stress urinary incontinence alone or the stress component in mixed urinary incontinence.

Patient satisfaction will be measured by symptom quality of life questionnaires (pre-operatively, 3 months and one year) and patient pain will be measured by verbal analogue rating scale (post-operative day 1 and day 7). Clinical efficacy will be measured by a cough stress test pre-operatively and post-operatively at 3 months and 1 year. A Q-tip test will also be performed pre-operatively and at 3 months and 1 year post-operatively. Subjects will be followed for a minimum of one year to evaluate recurrence of symptoms and complications, including the rate of mesh erosion, time to normal void in the post-operative period, the rate of sling revision, post-operative pain, voiding dysfunction and de novo urgency.

Eligibility Criteria:
Inclusion Criteria:

* Are at least 18 years of age
* Demonstrate a positive cough stress test during complex multi-channel urodynamic testing
* Demonstrate impact of stress urinary incontinence on quality of life questionnaire
* Are able to comprehend and sign a written informed consent
* Understand and are willing to comply with the study requirements, including agreeing to be available for the follow-up evaluations
* Are psychologically stable and suitable for interventions determined by the investigator
* Are ambulatory and able to use a toilet independently

Exclusion Criteria:

Patients:

* Who are pregnant or planning to become pregnant during the study or in the future
* With a elevated post-void residual (defined as PVR \> 100cc)
* With a bleeding condition or on anti-coagulant therapy
* With immunosuppression (i.e. HIV, lymphoma)
* With multiple sclerosis or other progressive neurological disease
* With evidence of a local or systemic infection, including urinary tract infection
* With evidence of intrinsic sphincter deficiency as defined by a maximal urethral closure pressure of \<20 cm H2O
* Previous sub-urethral sling
* Predominant overactive bladder symptoms
A Study to Assess Safety and Efficacy of Risankizumab Using a New Formulation in Participants With Moderate to Severe Plaque Psoriasis

The primary objective of this study was to evaluate the safety and efficacy of risankizumab (150 mg/mL) administered by prefilled syringe (PFS) for the treatment of adult participants with moderate to severe plaque psoriasis.

This was a Phase 3, multicenter, randomized, double-blind, placebo-controlled, parallel group study to evaluate the safety and efficacy of risankizumab 150 mg/mL formulation in PFS in adult participants with moderate to severe plaque psoriasis. The study included a 30-day screening period, a 28-week treatment period with study visits at Weeks 0, 4, 16 and 28, and a subsequent follow-up telephone call at approximately 20 weeks after the last dose of study drug. Study drug dosing consisted of 3 self-administered, subcutaneous (SC) doses on Weeks 0, 4, and 16. Dosing on Week 4 was self-administered at home.

Eligibility Criteria:
Inclusion Criteria:

* Participant has diagnosis of chronic plaque psoriasis for at least 6 months before the baseline visit.
* Participant meets following disease activity criteria:
* Stable moderate to severe chronic plaque psoriasis, defined as greater than or equal to 10% body surface area (BSA) psoriasis involvement, static physician global assessment (sPGA) score of greater than or equal to 3, and Psoriasis Area Severity Index (PASI) greater than or equal to 12 at Screening and baseline visit.
* Candidate for systemic therapy as assessed by the investigator.

Exclusion Criteria:

* Participant has history of active skin disease other than psoriasis that could interfere with the assessment of psoriasis.
* Participant has history of erythrodermic psoriasis, generalized or localized pustular psoriasis, medication-induced or medication-exacerbated psoriasis, or new onset guttate psoriasis.
* Participant has previous exposure to risankizumab.