cyrilzakka/clinical-trials huggingface dataset:
Effect of Mother's Push at Cesarean Delivery Mother's PUSHING AT CS A RANDOMIZED CONTROLLED TRIAL

The purpose of this study is to assess the safety and efficacy of the mother's active pushing during cesarean delivery.

Patients, who are getting a scheduled cesarean section and having no contraindication for valsalva manoeuvres are eligible for this study. The gestational week should be between 37 and 42 weeks. Patients have to provide informed consent to this study. Patients must have epidural anaesthesia. They must understand the German language in order to understand information during cesarean section and correctly fill-out the questionnaires. Emergent cesarean sections or pregnant women known with chronic pain, severe preeclampsia or HELLP-Syndrome will be excluded.

179 patients were initially recruited, of which 79 were excluded. The 100 patients were grouped into two study groups; Conventional and Assisted Groups. The grouping was performed randomly using simple randomization. Based on the findings of Armbrust et al and our clinical experience we expect a therapeutic effect of 20% which results in a mean visual analog scale reduction of 1.2. Applying a two-sided T-Test for independent samples at a significance level of 0.05, a mean difference of 0.8 between the groups and a standard deviation of 2, we need 17 patients per treatment arm to detect a difference between both treatment groups with a power of 80%14. The number of patients per treatment arm was increased to 50 patients to make up for any missing data.

Eligibility Criteria:
Inclusion Criteria:

* Minimum age of 18 years
* Written consent
* Pregnant women between 37 - 42 weeks
* No fetal abnormalities.
* Scheduled primary C-Section (category 3\&4 NICE guidelines) with epidural anaesthesia

Exclusion Criteria:

* Emergent cesarean section
* Contraindication for epidural anaesthesia.
* Multiple pregnancies
* Scheduled C-section with placenta previa, accreta, increta or percreta. Secondary C-section
* Contraindication for Valsalva manoeuvre
* Known psychiatric illnesses
* Known chronic Pain, taking Pain killers regularly
* language barrier
Treatment of Granuloma Umbilical in Newborn Babies

The investigators want to show that steroid creme and even better alcohol swaps are just as effective or equal to the current treatment with silver nitrate of granuloma umbilical in newborns.

The change of treatment will make it possible for parents to treat the children themselves at home, whereas treatment with silver nitrate only is an in hospital regimen.

Eligibility Criteria:
Inclusion Criteria:

* Gestational age more than 37 weeks
* More than 3 weeks old baby
* Granuloma umbilical diagnosed by a pediatrician
* No infections due to the umbilicus
* Parents do understand and speak danish

Exclusion Criteria:

* Gestational age less than 37 weeks
* Less than 3 weeks old baby
* Granuloma umbilical not diagnosed by a pediatrician
* Infections due to the umbilicus
* Parents do not understand or speak Danish
A Prospective Study of the Dry Eye Drink That Evaluates Hydration and Subject's Assessment on Eye Dryness

A study to assess the effect of the Dry Eye Drink on eye dryness

This is a prospective, non-randomized, comparative study of the Dry Eye Drink by Bruder Healthcare that evaluates hydration and subject's assessment on eye dryness. Subjects will administer the Dry Eye Drink by adding one sachet of the Dry Eye Drink powder in 12 Oz of water.

Eligibility Criteria:
Inclusion Criteria:

* Male and/or female subjects aged between 18 and 65 years (both limits inclusive).
* Subjects with symptomatic Dry Eye Syndrome confirmed at baseline in at least any one or both the eyes.
* Subjects with ≥ 310 mOsmol/L tear osmolarity.
* Subjects with ≥ 6 SPEED score.
* Subject willing to provide written informed consent and able to comply with protocol requirements.

Exclusion Criteria:

* Subjects who are pregnant, nursing, or planning a pregnancy within the study participation period.
* Have undergone mechanical treatment for meibomian gland dysfunction using thermal pulsation/expression (e.g., LipiFlow) or intense pulsed light (e.g., OptiLight) therapy within 6 months prior to the Screening/Baseline Visit
* Have a known hypersensitivity to any of the study product components
* Have undergone ocular surgery (e.g., cataract, corneal or refractive surgical procedure) within 6 months prior to the Screening/Baseline Visit
* Have evidence of clinically significant ocular trauma
* Have active ocular Herpes simplex or Herpes Zoster infection
* Have ocular inflammation (uveitis, iritis, scleritis, episcleritis, conjunctivitis or keratitis, with the exception of keratoconjunctivitis sicca) at the discretion of the investigator
* Have ocular infection (e.g., viral, bacterial, mycobacterial, protozoan or fungal infection of the cornea, conjunctiva, lacrimal gland, lacrimal sac or eyelids. including hordeolum)
* Have severe (Grade 3 or 4) inflammation of the eyelid (e.g., blepharochalasis, staphylococcal blepharitis or seborrheic blepharitis)
* Have eyelid abnormalities that significantly affect the lid function (e.g., entropion, ectropion, tumor, edema, blepharospasm, lagophthalmos, severe trichiasis, severe ptosis)
* Have an ocular surface abnormality that may compromise the corneal integrity (e.g., prior chemical burn, recurrent corneal erosion, corneal dystrophy, or the effect of any other ophthalmic medication that might in the opinion of the investigator compromise the ocular surface integrity)
* Have a systemic condition or disease not stabilized or judged by the Investigator to be incompatible with participation in the study or with the lengthier assessments required by the study (e.g., current systemic infection, uncontrolled autoimmune disease, uncontrolled immunodeficiency disease, history of myocardial infarction or heart disease, etc.)
* Participation in any clinical study within 30 days before the first administration of study product.
* Subjects who are illiterate and cannot complete the subject diary independently.
Comparative Study of Total Knee Arthroplasty Using a Customized-patient Specific Instrument System.

Patient-specific instrumentation (PSI) has been introduced in total knee arthroplasty (TKA) as a new technology for improving accuracy in restoration of the alignment and biomechanics of the lower limb. PSI in TKA refers to custom-made cutting jigs manufactured according to the patient's anatomic configuration of distal femur and proximal tibia based on preoperative magnetic resonance imaging (MRI) or computed tomography (CT) scans. MRI- and CT-based PSI systems are available from various manufacturers for preoperative planning. MRI offers precise visualization of articular cartilage without the risk of radiation exposure, but it is expensive and requires long scan times. In contrast, CT enables accurate identification of the contour of the femur and tibia at short scan times, but it does not provide information on the cartilage thickness and carries the risk of radiation exposure. As a result, there is a possibility of some discrepancy between the thickness of bone resection proposed by MRI- or CT-based PSI system and the actual thickness of bone cut. Although PSI has been the focus of study in many recent researches, there has been no clinical study comparing MRI-based and CT-based PSI systems in preoperative planning. Therefore the investigators questioned whether the MRI-based PSI that reflects the cartilage layer would provide more precision in TKA than the CT-based PSI. The purpose of this study was to investigate the accuracy of MRI-based PSI and CT-based PSI in predicting bone resection thickness in TKA.


Eligibility Criteria:
Inclusion Criteria:

* Of the patients who had been scheduled for TKA for the treatment of primary osteoarthritis only with varus deformity, those who had been waiting 6 weeks for TKA using an MRI-based or CT-based PSI system and had consented to the relatively new technique were enrolled in the study.

Exclusion Criteria:

* Patients with primary osteoarthritis with valgus deformity, rheumatoid arthritis, hemophilic arthritis, posttraumatic arthritis, other inflammatory arthritis, or a history of previous high tibial osteotomy were excluded from the study.
Efficacy and Safety of Imatinib in Scleroderma

In vitro studies have shown that imatinib 1mM inhibits strongly the growth of cutaneous fibroblasts. The hypothesis is that imatinib inhibits PDGFR which is known to be a potential target for the molecule, as recently also proposed after the discovery of autoantibodies activating the PDGF receptors. Recent data indicate that TGFb is also a potential target of imatinib. Cutaneous scleroderma is characterized by progressive cutaneous fibrosis caused by hyperactive dermal fibroblasts. Since no established treatment for skin sclerosis in scleroderma is currently available. This study will test the safety and efficacy of imatinib in the treatment of patients with scleroderma and severe cutaneous involvement.

This study will test the efficacy and tolerance of patients with a high score of induration (modified Rodnan score \> 20/54) Comparison : 34 patients with severe forms of cutaneous involvement will be evaluated in a double blind RCT comparing imatinib 400mg/j and placebo in a 6 month period. Efficacy will be assessed using a cutaneous induration scale and skin biopsy, and quality of life questionnaires.

Eligibility Criteria:
Inclusion Criteria:

* More than 18 years old
* Documented diagnostic of scleroderma (systemic or cutaneous)
* Severe cutaneous sclerodermia or systemic sclerodermia with m-Rodnan score \> 20/51
* Ejection fraction of more than 45 per cent at cardiac ultrasound pre-inclusion study
* Woman with efficient contraceptive method during trail treatment and during 3 month after the end of trial treatment
* All female patients with reproductive potential must have a negative pregnancy test (serum or urine) within the 7 days prior to enrolment
* Affiliated or profit patient of a social security system
* Signed informed consent

Exclusion Criteria:

* new systemic treatment, potentially interfering with disease progression, beginning 3 months prior the start trial treatment
* Patient with isolated cutaneous scleroderma treated with a drug potentially interfering with the course of the disease 4 weeks before starting the trial (Systemic corticosteroids, methotrexate, cyclophosphamide, bosentan)
* Scleroderma " en coup de sabre "
* Severe organ failure or anomaly of blood chemistry/hematology (bilirubin, SGOT, SGPT, creatinine \> 1,5 ´ upper normal limit, polymorphonuclear granulocytes less than 1\*10\*9/l or platelets less than 50\*10\*9/l),
* Ongoing cancer
* Ejection fraction ≤ 45 per cent at cardiac ultrasound pre inclusion study
* myocardial infarction of less than 6 mois at pre inclusion visit
* Non controlled chronic illness (diabetes, chronic kidney failure, chronic hepatitis, HIV infection),
* Major surgery less than two weeks before inclusion
* Pregnancy or lactation
* Absence of validated contraception in childbearing women.
* Contraindication to imatinib mesylate treatment as specified in product specifications
* Non observance anticipated and absence of informed consent
Safety and Efficacy of COBI-boosted Atazanavir Versus Ritonavir-boosted Atazanavir Each Administered With Emtricitabine/Tenofovir Disoproxil Fumarate in HIV-1 Infected, Antiretroviral Treatment-Naive Adults

The objective of this study is to evaluate the safety and efficacy of a regimen containing cobicistat-boosted atazanavir (ATV+COBI) plus emtricitabine/tenofovir disoproxil fumarate (Truvada®; FTC/TDF) fixed-dose combination (FDC) versus ritonavir-boosted atazanavir (ATV+RTV) plus FTC/TDF FDC in HIV-1 infected, antiretroviral treatment-naive adults.

Participants will be randomized in a 1:1 ratio. Randomization will be stratified by HIV-1 RNA level (≤ 100,000 copies/mL or \> 100,000 copies/mL) at screening.


Eligibility Criteria:
Inclusion Criteria:

* Ability to understand and sign a written informed consent form, which must be obtained prior to initiation of study procedures
* Plasma HIV-1 RNA levels ≥ 5,000 copies/mL at screening
* No prior use of any approved or investigational antiretroviral drug for any length of time
* Screening genotype report must show sensitivity to FTC, TDF and ATV
* Normal ECG
* Adequate renal function (eGFR calculated using the Cockcroft-Gault equation ≥ 70 mL/min)
* Hepatic transaminases (AST and ALT) ≤ 5 x upper limit of normal (ULN)
* Total bilirubin ≤ 1.5 mg/dL, or normal direct bilirubin
* Adequate hematologic function
* Serum amylase ≤ 5 x ULN
* Males and females of childbearing potential must agree to utilize highly effective contraception methods from screening throughout the duration of study treatment and for 30 days following the last dose of study drug.
* Age ≥ 18 years
* Life expectancy ≥ 1 year

Exclusion Criteria:

* A new AIDS-defining condition diagnosed within the 30 days prior to screening
* Receiving drug treatment for Hepatitis C, or anticipated to receive treatment for Hepatitis C
* Subjects experiencing decompensated cirrhosis
* Females who are breastfeeding
* Positive serum pregnancy test (female of childbearing potential)
* Have an implanted defibrillator or pacemaker
* Have an ECG PR interval ≥ 220 msec
* Current alcohol or substance use judged by the Investigator to potentially interfere with subject study compliance.
* A history of malignancy within the past 5 years or ongoing malignancy other than cutaneous Kaposi's sarcoma (KS), basal cell carcinoma, or resected, non-invasive cutaneous squamous carcinoma.
* Active, serious infections (other than HIV-1 infection) requiring parenteral antibiotic or antifungal therapy within 30 days prior to baseline.
* Medications contraindicated for use with COBI, emtricitabine (FTC), tenofovir disoproxil fumarate (TDF), atazanavir (ATV), ritonavir (RTV) or subjects with any known allergies to the excipients of COBI tablets, Truvada tablets, atazanavir capsules or ritonavir tablets.
* Participation in any other clinical trial without prior approval from the sponsor is prohibited while participating in this trial.
* Any other clinical condition or prior therapy that, in the opinion of the Investigator, would make the subject unsuitable for the study or unable to comply with the dosing requirements.
Virtual Care to Improve Post-Intensive Care Syndrome

The goal of this interventional trial is to learn about whether a virtual clinic can help patients with post-intensive care unit syndrome regain functional ability. Participants will participate in a 12-month online clinic where they will receive physiotherapy, nutritional planning, mental health support and cognitive strengthening. Functional capacity will be measured throughout the clinic. After, they will be asked questions about their clinic experience, and complete a questionnaire.

Virtual Care to Improve Post-Intensive Care Syndrome (V-PICS) is a multidisciplinary virtual clinic designed to address the three components of post-intensive care syndrome (PICS): physical impairment, cognitive decline and mental health challenges. This initiative targets ICU survivors who received mechanical ventilation for a minimum of 48 hours. Referred patients will access live sessions with healthcare professionals who will guide at-home strategies to address PICS including physiotherapy, nutritional planning, mental health support and cognitive strengthening. The clinic will provide an integrated approach to addressing the challenges faced by ICU survivors. The feasibility of this virtual clinic will be assessed by measuring patient satisfaction, clinic effectiveness and levels of engagement and attendance. The study's findings will inform the creation of a robust multi-centre clinical trial that will contribute to the creation of a national standard of PICS care and increase health system efficiencies.

Eligibility Criteria:
Inclusion Criteria:

* over 18 years of age
* received mechanical ventilation for a minimum of 48 hours in the ICU
* discharged from the hospital in the 2 months prior to study start

Exclusion Criteria:

* Individuals originating from an assisted living/ long-term care facility
* lack a capacity for informed consent
* have end-stage illnesses
* present a significant fall risk
* cannot speak English or French
* do not have the technological skills or caregiver support to ensure digital literacy
Functional Exercise Training With Adolescents With Cerebral Palsy

This cross-over study analyzes a novel and inclusive approach in how therapy for adolescents with CP is administered, with the main goal of examining the effects of a functional exercise intervention on motor capability and motor capacity.

It is to investigate the effects of a functional movement-based exercise intervention in a group setting on motor capacity, motor capability and quality of life in adolescents with CP compared to standard therapy.

Cerebral palsy (CP) is a permanent disorder which affects the development of movement and posture. It causes activity limitation and is oftentimes accompanied by secondary musculoskeletal problems, disturbances of sensation, perception, cognition, communication and behavior.

In regard of the complex interplay between physical restrictions, motor disabilities, sedentary lifestyles and low participation in physical activity, an innovative exercise intervention study for adolescents with CP is intended in order to break the stated vicious cycle. This study aims at providing a novel and inclusive approach in how therapy for adolescents with CP is administered, with the main goal of examining the effects of a functional exercise intervention on motor capability and motor capacity.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of CP.
* Adolescents between 12 and 18 years of age.
* Gross Motor Functional Classification System (GMFCS): I-III.
* Cognitive abilities must include: Ability to actively engage in a training session of 60 min. duration; Ability to verbally or non-verbally communicate pain or discomfort; Ability to attend training, testing and follow-up sessions. All included participants are capable of making decisions on their own and no not show any signs of mental or cognitive limitations.

Exclusion Criteria:

* Any surgery or botulinum toxin treatment within 6 months prior to the start of the study or surgery/serial casting / botulinum toxin injection scheduled during the study period. Other medications can be continued as prescribed by the participants' physician.
* Known cardiovascular or pulmonary diseases that have not received medical clearance to participate in the physical exercise intervention.
* Uncontrolled seizures or epilepsy
A Study to Evaluate Efficacy of Ivacaftor in Subjects With Cystic Fibrosis Who Have a 3849 + 10KB C→T or D1152H CFTR Mutation

This study will evaluate the efficacy of ivacaftor treatment in subjects with CF 6 years of age and older who have a 3849 + 10KB C→T or D1152H CFTR mutation.


Eligibility Criteria:
Inclusion Criteria:

* Confirmed diagnosis of CF based on protocol-specified clinical features and at least one of the following: increased sweat chloride level, identification of 2 CF causing mutations, or demonstration of abnormal nasal epithelial ion transport.
* A 3849 + 10KB C→T or D1152H mutation on at least 1 CFTR allele.
* FEV1 ≥40% of predicted and ≤105% of predicted at screening.

Exclusion Criteria:

* A G551D, G1244E, G1349D, G178R, G551S, S1251N, S1255P, S549N, S549R, or R117H mutation.
* History of any illness or any clinical 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 subject.
* Ongoing or prior participation in an investigational drug study within 30 days before the Screening Visit.
* Protocol-specified abnormal laboratory values at the Screening Visit
* For subjects \<18 years of age at the Screening Visit, evidence of cataract/lens opacity determined to be clinically significant by the ophthalmologist or optometrist during the ophthalmologic examination (OE) at the Screening Visit.
* Use of any moderate or strong inducers or inhibitors of cytochrome P450 (CYP) 3A, including consumption of certain herbal medications and certain fruit and fruit juices, within 14 days before Day 1.
* Pregnant, breastfeeding, or planning to become pregnant during the study.
* Sexually active subjects of reproductive potential must be willing to use appropriate contraception.
Resilient Together for Dementia

The proposed study will establish the feasibility, acceptability and credibility of a novel live video dyadic resiliency intervention, Resilient Together for Dementia (RT-D), aimed at preventing chronic emotional distress and preserving quality of life among dyads at risk for chronic emotional distress early after a diagnosis of Alzheimer's disease or a related dementia (ADRD).

Both persons living with dementia (PWDs) and their spousal care-partners experience high levels of clinically elevated emotional distress, which can become chronic without treatment and negatively impact the health, quality of life, communication, and care-planning of both partners. A tailored dyadic intervention, such as the proposed Resilient Together for Dementia, delivered over live video to this at risk population during the window of opportunity when PWDs can participate has the potential to prevent chronic emotional distress and preserve quality of life for PWDs and their loved ones.

Eligibility Criteria:
PWD inclusion criteria are:

* Recent (\~1 month) chart documented ADRD diagnosis,
* ADRD symptom onset after age 65 ,
* cognitive assessment scores and symptoms consistent with early stage dementia, as determined by the Clinical Dementia Rating Scale scores of .5 or 1.0
* cognitive awareness of his/her problems (as determined by the treating neurologist), and
* ability to understand study and research protocol, as determined by a standardized teach-back method assessment84.

Additional inclusion criteria for dyads are:

* English speaking adults (18 years or older),
* dyad lives together,
* at least one partner endorses clinically significant emotional distress during screening (\>7 on Hospital Anxiety and Depression scale subscales)

Exclusion Criteria:

* patient is deemed inappropriate by the neurology team,
* either partner has a co-occurring terminal illness,
* patient was diagnosed with forms of dementia with clinical profiles that would preclude participation (e.g., Frontotemporal Dementia- behavioral variant), as determined by treatment team.