cyrilzakka/clinical-trials huggingface dataset:
Development & Validation of Pregnancy Specific Pelvic Floor Rehab Protocol

Pelvic Floor Weakness is very common Facing by women during Pregnancy. PFM weakness is recognized as one of the problems encountered in patients with urinary and fecal incontinence which have very negative impact on Quality of life of Patients. This project aims to design, implement, and validate a pelvic floor rehabilitation protocol specifically for pregnant individuals.

The review of existing literature undergoes the critical need for a pregnancy-specific pelvic floor rehab protocol to address the unique physiological and functional changes experienced during and after pregnancy. While current pelvic floor rehab approaches provide valuable insights, they often lack specific adaptations for the pregnant population, In First Phase of Study the protocol will be developed .The protocol will focus on preventing and managing pelvic floor dysfunction (PFD), such as urinary incontinence, pelvic organ prolapse, and pelvic pain, which are common during pregnancy. The program will incorporate evidence-based exercises, education, and lifestyle modifications, ensuring it is safe, effective, and adaptable to pregnancy.

In Second Phase it will be validated and Pilot testing will be done.

Eligibility Criteria:
Inclusion Criteria:

* diagnosed pelvic floor dysfunction. Female participants experience pelvic floor symptoms such as incontinence, pelvic pain, or prolapse.

No previous participation in a structured pelvic floor rehabilitation program within the last six months

Exclusion Criteria:

* Pregnant women or those planning to become pregnant during the study period.
* Patients with neurological disorders affecting pelvic floor function (e.g., multiple sclerosis, spinal cord injury).
* Individuals with severe psychiatric conditions that might interfere with participation.
* Recent pelvic surgery within the last three months.
* Any contraindications to physical therapy or specific exercises included in the rehab program.
Effects of Intra-Operative Ropivaciane Epidural Injection on Post-Operative Outcomes Following Elective Lumbar Fusion

The following is a double blinded, randomized controlled clinical trial to test the hypothesis that a single epidural injection of Ropivaciane® intra operatively will:1) Single intra-operative epidural injection of Ropivaciane® will result in decreased postoperative pain and opioid use in both minimally invasive (MIS) and open lumbar fusion patients; 2) Decreased postoperative pain will lead to improved clinical outcomes; and 3) Elucidate if there are differences in pain management between MIS and open surgical procedures. The proposed study will add novel information to current knowledge by 1) exploring of the effects of intra-operative single epidural injection analgesic on patients receiving MIS compared to open surgery, and 2) investigate potential immediate and short-term functional improvements gained from intra-operative single injection of Ropivaciane®.

This double blinded, randomized clinical trial will test hypotheses by administering a single epidural injection prior to wound closure of either Ropivaciane® or saline.All pre-surgical activities and anesthesia will proceed as usual, with the addition of a single epidural injection immediately prior to wound closure 2 levels, or 10cm above the operated spinal level. Experimental groups will receive 0.2% Ropivaciane® (10 ml; dose shown to be effective without transient weakness), 9 and the control group will receive 0.9% saline solution (10 ml). Accurate placement into the space will be verified by the injection of contrast medium (iohexol, 180 mgl/ml) under fluoroscopic guidance. Epidural solutions will be prepared prior to surgery by pharmacy and coded; surgeons will administer according to the patient's code maintaining the double-blind procedure. It is important to note that treatment as usual differs between open and MIS cohorts. The question of interest is whether the addition of the epidural analgesic to current practices for each surgery type results in increased positive outcomes, whether this is due to synergistic effects or not. Following operative treatment, Foley Urinary catheter will be removed 24 hours post-operatively, unless otherwise clinically indicated.

Eligibility Criteria:
Inclusion Criteria:

* Consenting participants undergoing elective 1-2 level lumbar fusion through the Canada East Spine Centre

Exclusion Criteria:

* History of severe respiratory, renal or hepatic disease
* Previous spine surgery
* Known allergy to local anaesthesia
* Those who experience dural tear during operative procedure
Assessment of Breathing Using an Under-bed Weighing Scale

The aim of this study is to assess the capability of a modified under bed weighing scale (contact-free unconstrained respiratory monitor, BSS) to predict postoperative pulmonary complications in high-risk surgical patients.

The study is designed to test the hypothesis that abnormal breathing measured by a modified under bed weighing scale predicts postoperative pulmonary complications within 7 days after surgery.


Eligibility Criteria:
Inclusion Criteria:

1. Age 18 years or older
2. Undergoing non-cardiac surgery under general anesthesia.
3. Score ≥ 25 in the risk prediction score (Table1)

Exclusion Criteria:

1. Ambulatory (outpatient) surgery
2. Transfer directly to the ICU
3. Remain intubated/ planned to remain intubated after surgery
4. Pregnant patients: as detected by patient self-reporting of diagnosed by preoperative pregnancy testing according to institutional policies at BIDMC.
5. Patients enrolled in other interventional studies which could confound the primary endpoint.
Study to Evaluate Safety, Tolerability, PK and PD of DCR-PHXC in PH Type 3 Patients

The DCR-PHXC-104 study is designed to assess the safety, tolerability, and pharmacological parameters of a single dose of DCR-PHXC in Primary Hyperoxaluria Type 3 (PH3). Participants should have had at least one stone event within 12 months of screening and intact renal function.

Potential participants are screened over an up-to-35-day period (with an extra 7-day period for participants who are required to repeat screening 24-hour urine collections or initially unanalyzable screening laboratory assessment samples) prior to randomization. Eligible participants will receive a single dose of DCR-PHXC or placebo on Day 1.

In order to maintain the treatment blind, 24-hour urine oxalate (Uox) results that could unblind the study will not be reported to investigative sites or other blinded personnel until the study has been unblinded.

It is expected that approximately 10 participants will be screened in order to randomize 6 participants (2:1 randomization; 4 nedosiran:2 placebo) to the study.

Following the up-to-6-week screening period, participants will return to the clinic for interim visits up to Day 85. Visits occurring between the Day 1 and the Day 85 visit may be conducted as at-home telemedicine visits at the discretion of the Investigator. The total time on study for each participant is approximately 18 weeks.

Eligibility Criteria:
Key Inclusion Criteria:

* Genetically confirmed PH3
* 24-hour Uox excretion ≥ 0.7 mmol (adjusted per 1.73 m\^2 body surface area \[BSA\] in participants \< 18 years of age) on both assessments conducted in the screening period
* Less than 20% variation between the two 24-hour urinary creatinine excretion values (mmol/kg/24 hours) in the screening period
* Estimated glomerular filtration rate (eGFR) at screening ≥ 30 mL/min, normalized to 1.73 m\^2 BSA
* History of at least one stone event within the last 12 months. Stone events are defined as any of the following:

  * renal stone requiring medical intervention, e.g., outpatient procedures such as lithotripsy, or hospitalization or inpatient surgical intervention for confirmed stone-related pain and/or complications;
  * stone passage with or without hematuria; or
  * renal colic requiring medication.

Key Exclusion Criteria:

* Documented evidence of clinical manifestations of systemic oxalosis (including pre-existing retinal, heart, or skin calcifications, or history of severe bone pain, pathological fractures, or bone deformations)
* Plasma oxalate \> 30 μmol/L
RElevance of Biomarkers for Future Risk of Thromboembolic Events in UnSelected Post-myocardial Infarction Patients

The study is an open, single center, observational study at the Cardiology Dept at Uppsala University Hospital. The number of patients included will be 410. The objectives are to:

Evaluate biomarkers and change of these related to myocardial infarction, during two years follow-up in an unselected patient population with a recent myocardial infarction.

Evaluate if an early change of biomarkers can be related to death, new myocardial infarction, and ischemic stroke in the same population after two and five years follow-up.


Eligibility Criteria:
Inclusion Criteria:

1. Myocardial infarction diagnosed by dynamic raised troponin I with at least one value above 0.1 µg/L. Together with at least one of the criteria; symptoms suggestive for myocardial infarction or development of significant Q wave.
2. Treated at the Department of cardiology, Uppsala University Hospital.
3. Ability to attend the scheduled visits for evaluation procedures.
4. Signed Informed Consent.

Exclusion Criteria:

1. Death ≤ 5 days after the myocardial infarction.
2. Not belonging to the catchment area of Uppsala University Hospital.
3. Lack of suitability for participation in the trial, for any reason, as judged by the Investigator.
Methylene Blue Versus Vasopressin Analogue for Treatment of Septic Shock in Preterm Neonate

A randomized, prospective study comparing methylene blue versus terlipressin in treatment of catecholamines resistant shock in preterm neonate

The study will be an un-blinded, Phase 2, randomized, 1:1, prospective trial comparing methylene blue versus terlipressin in treatment of preterm neonate with catecholamines resistant septic shock the outcome as regard elevation of mean arterial blood pressure will be measured within 72 hours

Eligibility Criteria:
Neonate with Gestational age at birth ≤ 36weeks

Inclusion Criteria:

* diagnosis of Septic shock according to clinical sepsis score of Tollner and Hematologic Scoring System of Rodwell
* Refractory septic shock defined as hypotension although adequate fluid resuscitate and high dose vasopressor(NE \>0.5 mcg/kg/min)
* consent form

Exclusion Criteria:

* known case of G6pd deficiency
* Hx of drug allergy MB, NE, terlipressin
* Patients with severely impaired renal function.
* History of maternal drug intake of selective serotonin reuptake inhibitors,and Serotonin-Norepinephrine Reuptake Inhibitors
A Study Evaluating the Clinical Performance of the ViaValve™ Safety IV Catheter

The objective of this post-market, prospective study is to evaluate the clinical acceptability, blood leakage, risk for blood exposure, need for digital compression, insertion success, and clinical utility of the ViaValve™ Safety IV Catheter compared to standard hospital PIVCs currently being used.


Eligibility Criteria:
Inclusion Criteria:

* A peripheral intravenous catheter will need to be inserted in order to gain access to a vein or artery to sample blood, monitor blood pressure, or administer fluids intravenous infusion as part of treatment.
* Willing and able to sign an Informed Consent (patient or legally authorized representative).

Exclusion Criteria:

* Body morphology (e.g., size) precludes the use of a peripheral intravenous catheter.
* Fluid to be infused is not appropriate for peripheral intravenous catheters.
Effects of Pulmonary Hypertension Therapy in Atypical Pulmonary Arterial Hypertension

The purpose of this study is to characterize the clinical and hemodynamic response of Pulmonary Arterial Hypertension (PAH) therapy in patients with atypical PAH and risk factors for left heart disease.

This is an observational prospective study to better understand the clinical impact of Pulmonary Arterial Hypertension (PAH) specific therapy in patients with atypical PAH among those with risk factors for left heart disease

The study involves detailed baseline clinical evaluation prior to initiation of PAH therapy, followed by repeat clinical assessment after 6 months of medical therapy

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* Pulmonary hypertension with mean PA pressure \>20 mmHg and a planned initiation of pulmonary arterial hypertension therapy
* No active treatment for precapillary pulmonary hypertension
* Ambulatory (not wheelchair/scooter dependent)
* Presence of any risk factor for left heart disease will qualify for inclusion (either atrial fibrillation, body mass index\>30 kg/m2, arterial hypertension, diabetes, coronary artery disease or age\>60 years)

Exclusion Criteria:

* Significant chronic obstructive pulmonary disease that is a primary contributor to symptoms in the opinion of the investigator
* Ischemia thought to contribute to dyspnea in the opinion of the investigator
* Obstructive hypertrophic cardiomyopathy
* Known infiltrative cardiomyopathy (amyloid)
* Constrictive pericarditis or tamponade
* Active myocarditis
* Complex congenital heart disease
* More than mild aortic or mitral stenosis
* Intrinsic (prolapse, rheumatic) valve disease with more than moderate mitral, tricuspid or aortic regurgitation
* Acute or chronic severe liver disease as evidenced by any of the following: encephalopathy, variceal bleeding, INR \> 1.7 in the absence of anticoagulation treatment
* Terminal illness (other than HF) with expected survival of less than 1 year
* Enrollment or planned enrollment in another therapeutic clinical trial in next 3 months.
* Inability to comply with planned study procedures
* Pregnancy or breastfeeding mothers
Evaluation of Topic Anaesthesia for Laryngoscopy With Fibroscopy During Paediatric Ear Nose Throat (ENT)Consultation

The purpose of this work is to estimate the efficiency in terms of pain of the application of a local anesthetic (xylocaïne viscous 2%®) during the realization of an examination in naso-fiberscopy in consultation of ENT at the child from 3 to 7 years old.


Eligibility Criteria:
Inclusion Criteria:

* Subjects from 4 to 7 years old (old enough to answer the test of self-assessment, the scale of faces)
* Appearing at the consultation of pediatric ENT, requiring an indirect laryngoscopy in the naso-fiberscope for a laryngeal evaluation.
* Subjects girls or boys

Exclusion Criteria:

* All the criteria dissuading the employment of a local anesthetic
* Naso-fibroscopie realized within the framework of a nasal obstruction, or of a balance sheet of the gulp.
* Patients having already been examined by naso-fiberscopy, so that their reactions and their answers are not influenced by the previous experience of the examination.
* Not consent of one of both holders of the parental authority
Safety, Tolerability, and Efficacy Study of Valoctocogene Roxaparvovec in Hemophilia A With Active or Prior Inhibitors

This Phase I/II clinical study will evaluate the safety and efficacy of valoctocogene roxaparvovec in patients with severe haemophilia A and inhibitors to FVIII. Part A of the study will involve subjects who have active inhibitors to FVIII, and Part B involving subjects with a prior history of inhibitors.


Eligibility Criteria:
Inclusion Criteria:

1. Males ≥ 18 years of age with hemophilia A and documented prior residual FVIII activity ≤ 1 IU/dL including, but not limited to, at the time of detected inhibitors, at the time of signing the informed consent.
2. History of a positive inhibitor result with the first positive result at least 12 month prior to Screening.

   Part A: Demonstrated no immunological tolerance to exogenous FVIII. Part B: Demonstrated tolerance to exogenous FVIII and negative FVIII inhibitor screening titer \< 0.6 BU.
3. Prophylactic or on-demand hemophilia therapy in the last 12 months. Bleeding, inhibitor \& hemophilia therapy Hx over previous 12 months.
4. Sexually active participants must agree to use an acceptable method of effective contraception. Participants must agree to contraception use for at least 12 weeks post-infusion.
5. Willing to abstain from consumption of alcohol for at least the first 52 weeks following BMN 270 infusion.

Exclusion Criteria:

1. Detectable pre-existing antibodies to the AAV5 capsid.
2. Any evidence of active infection or any immunosuppressive disorder; patients with HIV infection and undetectable viral load are not excluded.
3. Currently undergoing, or plan to receive during the study, immune tolerance induction therapy or prophylaxis with FVIII (Part A only).
4. Significant renal dysfunction or liver dysfunction, infection or history of hepatic malignancy.
5. Evidence of any bleeding disorder not related to hemophilia A.
Emergency Obstetric and Neonatal Care: The EmONC Trial

The objective of this cluster randomized controlled trial is to reduce maternal and neonatal mortality by increasing access to and improving the quality of obstetric and neonatal care for pregnant women in study clusters. It is hypothesized that a 25% reduction in \>28 week or \>1000 gram stillbirth and 7-day neonatal mortality will be achieved in the intervention clusters by a multifaceted Emergency Obstetric Neonatal Care (EmONC) package that will be introduced by an EmONC team.

Maternal death, stillbirth, early neonatal death, and obstetric fistula are among the most devastating adverse outcomes of pregnancy. Existing interventions could avert the majority of maternal and neonatal deaths; however, those women at greatest risk are least likely to have access to interventions delivered through the formal health care system. In many developing countries, most deliveries in rural areas and a significant number in urban areas are conducted at home without skilled attendance, circumstances which pose a high risk for both mothers and their neonates. The EmONC trial is designed to evaluate a comprehensive intervention encompassing community mobilization to establish and sustain mechanisms of transport and payment and to drive client-oriented emergency obstetrical and neonatal care. The intervention includes teaching recognition of prolonged labor, infection, preeclampsia and hemorrhage, and the use of appropriate stabilization methods by all community birth attendants. In addition, poor access to quality emergency obstetric and neonatal care in a sustainable manner will be addressed. To evaluate the effectiveness of this approach, a cluster-randomized trial is required to assess whether Cluster EmONC teams can work with the community and health care system to reduce adverse pregnancy outcomes in diverse settings where the majority of deliveries occur at home or at a health clinic with few or no available EmONC interventions. To accomplish the intervention, a train-the-trainer approach will be used. Master trainers will facilitate central and regional training sessions for Country trainers organized around the areas of community mobilization; birth attendant skills; and EmONC referral facility improvements. The Country trainers will then support training and related activities in the intervention clusters, predominantly focusing on these three areas. The study population includes pregnant women (and their neonates) living and delivering in the 108 study clusters. The study clusters are largely rural, geographically distinct communities, each of which have approximately 300 annual deliveries. The women will be enrolled at or after 20 weeks gestation and followed to 42 days post delivery. The total duration of the trial will be 24 months.

Eligibility Criteria:
Inclusion Criteria:

1. Pregnant women living in and/or delivering within the study cluster
2. Consent provided

Exclusion Criteria: Eligible pregnant women who do not consent
Triton Fundus Autofluorescence and Fluorescein Angiography

Compare the image quality of the fundus autofluorescence and fluorescein angiography

The objectives of this study are to:

1. Compare the image quality of the fundus autofluorescence (FAF) photographs between DRI OCT Triton (plus) and TRC-50DX retinal camera.
2. Compare the image quality of the fluorescein angiography (FA) photographs between DRI OCT Triton (plus) and TRC-50DX retinal camera.

Eligibility Criteria:
Inclusion Criteria

1. Subjects must be at least 18 years of age
2. Subjects able to understand the written informed consent and willing to participate as evidenced by signing the informed consent
3. Subjects who consent to, via clinic's standard FA consent form, and will undergo dye injection for FA imaging at the clinic visit based on medical need

Exclusion Criteria

1. Subjects unable to tolerate ophthalmic imaging
2. Subjects with ocular media not sufficiently clear to obtain acceptable fundus images
3. Patients with ocular motility dysfunction
Vitamin A and D Intake in Pregnancy, Infant Supplementation and Asthma Development

The objective of this study is to investigate if maternal intake of vitamins A and D from food and dietary supplements during pregnancy, and infant supplementation with these vitamins, are associated with development of asthma in the offspring.

This study was conducted as part of the research project "Causal pathways for asthma" funded by the Norwegian Research Council (2013-2017). The overall objective was to study if different pregnancy and early life exposures affect the risk of asthma and allergic diseases in children, and if these exposures exert their effects through epigenetic mechanisms, more specifically DNA methylation.

For this project, including the current study, existing data from the Norwegian Mother and Child Study (MoBa file version 9, 115 398 children and 95 248 mothers) were linked with the Medical Birth Registry of Norway and the Norwegian Prescription Database. The MoBa study recruited pregnant women between 1999 and 2008, at approximately 18 weeks of gestation. Beginning 2002, women completed a food frequency questionnaire about dietary intake (food and supplements) in pregnancy. A panel of maternal plasma biomarkers, including plasma retinol and 25-hydroxyvitamin D2 and D3, was available for a random sample of around 3,000 women who gave birth in 2002 and 2003.

Eligibility Criteria:
Inclusion Criteria:

Available maternal dietary intake data from pregnancy. Child turned 7 years by July 1st 2014.

Exclusion Criteria:

No maternal baseline questionnaire. Maternal energy intake \<4,500 or \> 20,000 kJ. No dietary supplement data. No linkage to national birth registry, or non-live births, or multiple births. Child death, or emigration, or unknown vital status.
Exercise for Low Back Pain in Children

This study aimed to determine the efficacy of an eight-week specific exercise programme in reducing self-reported episodes and intensity of LBP, as well as modifying some of the identified risk factors for LBP, in children.


Eligibility Criteria:
Inclusion Criteria:

* Children aged 12-13 years
* Complained of LBP in the past three months

Exclusion Criteria:

* Serious spinal pathologies or deformities (e.g. severe scoliosis, spinal tumours)
* Neurological conditions which alter motor tone
* Physical disabilities (e.g. spinal cord injuries) which prevent the child from being able to stand up on their own without an orthotic device or brace, or which prevent the child from taking part in normal physical education (PE) classes
* Any other serious co-morbidities (e.g. cancer, severe lung pathology)
* Provincial sports participants, or children who were currently following a specific training programme with a biokineticist or physiotherapist
* Current orthopaedic procedures or fractures of the spine, pelvis, lower or upper limbs