cyrilzakka/clinical-trials huggingface dataset:
Magnesium Sulphate Versus Lidocaine for Control of Emergence Hypertension

Post-craniotomy emergence hypertension is a common phenomenon that may predispose to development of intracranial hematoma and cerebral edema.The aim of this study is to compare the safety and efficacy of Mgso4 versus lidocaine infusion for control of emergence hypertension after craniotomy.


Eligibility Criteria:
Inclusion Criteria:

* ASA physical status Ι or Π.
* scheduled patients for brain tumor excision.

Exclusion Criteria:

* Hepatic, renal, cardiac, pulmonary, or endocrine impairment.
* Signs of increased intracranial pressure or allergy to any of the used drugs.
Efficacy of XL184 (Cabozantinib) in Advanced Medullary Thyroid Cancer

The purpose of this research study is to evaluate the progression-free survival (PFS) with XL184 as compared with placebo (an inactive substance) in subjects with unresectable, locally advanced, or metastatic medullary thyroid cancer (MTC). Subjects will be randomized to receive XL184 or placebo in a 2:1 ratio. XL184 is an investigational drug that inhibits VEGFR2, MET and RET, kinases implicated in tumor formation, growth and migration.

The Clinical Steering Committee for this study, comprised of study doctors who specialize in medullary thyroid cancer, has provided guidance regarding the design of the study. The committee includes: Douglas Ball, MD, Barry Nelkin, PhD, Martin Schlumberger, MD and Steven Sherman, MD.


Eligibility Criteria:
Inclusion Criteria:

* The subject has a histologically confirmed diagnosis of MTC that cannot be removed by surgery, is locally advanced, or has spread in the body.
* The subject is at least 18 years old.
* The subject has an ECOG (Eastern Cooperative Oncology Group) performance status ≤ 2.
* The subject has documented worsening of disease (progressive disease) at screening compared with a previous CT scan or MRI image done within 14 months of screening.
* The subject has recovered from clinically significant adverse events (side effects) due to any other medications that were administered prior to randomization.
* The subject has adequate organ and bone marrow function.
* Subjects who are sexually active (male and female) must agree to use medically accepted methods of contraception during the course of the study and for 3 months following discontinuation of study treatments.
* The subject has no other diagnosis of cancer (unless non-melanoma skin cancer, an early form of cervical cancer, or another cancer diagnosed ≥ 2 years previously) and currently has no evidence of malignancy (unless non-melanoma skin cancer or an early form of cervical cancer).
* Female subjects of childbearing potential must have a negative pregnancy test at screening.

Exclusion Criteria:

* The subject has received prior treatment for their cancer within 4 weeks of randomization (6 weeks for nitrosoureas or mitomycin C).
* The subject has received radiation to ≥ 25 % of bone marrow.
* The subject has received treatment with other investigational agents (unapproved therapies) within 4 weeks of randomization.
* The subject has received treatment with XL184.
* The subject has brain metastases or spinal cord compression, unless completed radiation therapy ≥ 4 weeks prior to randomization and stable without steroid and without anti-convulsant treatment for ≥ 10 days.
* The subject has a history of clinically significant episodes of vomiting blood or a recent history of vomiting \> 2.5 mL (about 1/2 teaspoon) of red blood.
* The subject has serious illness other than cancer.
* The subject is pregnant or breastfeeding.
* The subject has an active infection requiring ongoing treatment.
* The subject is incapable of understanding and complying with the protocol or unable to provide informed consent.
Comparison of the Femoral Prothesis-rotation in Conventional X-ray, in Axial CT Slices and 3D-reconstructed CT

Femoral component rotation in total knee arthroplasty (TKA) has been considered an important factor for outcome. However, measurement of femoral component rotation is difficult to perform.

Femoral TKA component rotation can be assessed on special radiographs (Kanekasu technique), axial CT slices and 3D reconstructed CT images.

It was the hypothesis that measurements on radiographs are comparable to measurement on CT images.

Measurements of femoral TKA rotation will be measured three times by three different observers and inter- and intraobserver reliability is calculated. The absolute values of each measurement method is noted in degrees.

Femoral component rotation in total knee arthroplasty (TKA) has been considered an important factor for outcome. However, measurement of femoral component rotation is difficult to perform.

Femoral TKA component rotation can be assessed on special radiographs (Kanekasu technique), axial CT slices and 3D reconstructed CT images.

It was the hypothesis that measurements on radiographs are comparable to measurement on CT images.

In agreement with our standard diagnostic algorithm for patients with pain and problems after TKA CT images as well as Kanekasu radiographs are performed. If the Kanekasu radiograph is comparable reliable, it could be possible to use this radiograph instead.

Measurements of femoral TKA rotation will be measured three times by three different observers and inter- and intraobserver reliability is calculated. The absolute values of each measurement method is noted in degrees. The measurements are performed with two weeks interval and the different observers are blinded to their previous and the measurements of the others.

The absolute difference of femoral TKA rotation is calculated between and inter the groups investigated.

Intra class correlation coefficients are calculated for inter- and intraobserver reliability.

Eligibility Criteria:
Inclusion Criteria:

* Total Knee prosthesis (primary)
* \>55 years

Exclusion Criteria:

* pregnancy
* lactating women
Comparison of Physiotherapy Versus Home Exercise Following Hip Replacement Surgery

A Randomized Controlled Trial of Outpatient Physiotherapy versus a Self-Administered Home Exercise Program Following Discharge Home from Total Hip Arthroplasty


Eligibility Criteria:
Inclusion Criteria:

* primary THA (cemented or cementless)
* preoperative diagnosis of osteoarthritis (primary or secondary)
* meets objective discharge-to-home test following hip replacement
* ability to speak English and reply to questionnaires written in English
* ability to provide informed consent
* may include patients presenting for their second primary hip arthroplasty

Discharge to Home Criteria

* independent supine-to-sit transfer
* independent sit-to-stand transfer
* walk with walking aid 30 meters
* ascend and descend 3 stairs
* deemed medically fit and safe for home environment by surgeon/nursing/PT

Exclusion Criteria:

* surgery as part of a workers' compensation claim
* arthroplasty performed for trauma or following open reduction and internal fixation, malignancy or inflammatory arthropathy
* intra-operative complication of fracture or sciatic nerve injury
* procedure requiring complex surgical approach other than posterior or anterolateral (ie trochanteric osteotomy/micro 2 incision approach)
* indications for additional primary or revision arthroplasty within the time frame of the study (24 months) in other hip or knee joints which would adversely affect quality of life and functional scores pertaining to the joint of interest
Intravenous Infusion of Paracetamol for Intrapartum Analgesia of Labor

This is a double-blind randomized trial evaluates the efficacy of intravenous infusion of Paracetamol as intrapartum analgesic in the first stage of labour.

Comparison of efficacy and safety of intravenous infusion of paracetamol versus placebo (intravenous sterile water infusion) in parturient women in active first phase of labour and requiring intrapartum analgesia.

Eligibility Criteria:
Inclusion Criteria:

1. Age between 18-35 years.
2. Primigravida.
3. The gestational age between 37- 42 weeks.
4. Patient seeking analgesia.
5. Single viable fetus.
6. Vertex presentation.
7. Spontaneous onset of labor.
8. 1st stage of labor with cervical dilatation 3-4 cm ( in active phase).

Exclusion Criteria:

1. Extreme of age (below 18-above 35).
2. Multiparity.
3. Multiple gestation.
4. Malpresentation.
5. Major degree of cephalopelvic disproportion.
6. Any medical disorder with pregnancy e.g., Rheumatic heart disease, Diabetes mellitus, Hypertension, Anemia.
7. Induction of labor.
8. Cervical dilatation exceeds exceeding 4 cm.
9. Use of any other kind of analgesia before recruitment in the study.
10. Scared uterus.
11. Fetal distress.
12. Antepartum hemorrhage.
13. Intrapartum bleeding.
14. Polyhydramnios.
15. Pre-mature rupture of membranes.
16. Intra uterine infections.
17. Hypersensitivity to paracetamol.
Multimodal Assessment of Liver Volume and Function

In liver surgery peroperative assessment och the future liver remnant (FLR) is pivotal in order to avoid posthepatectomy liver failure. To date this is mainly performed by measuring the volume of the FLR. Of course FLR volume acts as a surrogate measure of FLR function and the correlation between volume and function is not always accurate. Several techniques to assess FLR function has been proposed. Hepatobiliary scintigraphy (HBS) and Dynamic MRI are the two such methods. In this study we compare HBS and MRI, in addition to contrast-enhanced CT and ICG, repeatedly performed before and after right hepatectomy in patients with colorectal liver metastases treated with neoadjuvant chemotherapy.


Eligibility Criteria:
Inclusion Criteria:

* CRLM treated with neoadjuvant chemotherapy subjected to right hepatectomy

Exclusion Criteria:

-
Identification of Inpatients at Risk for Poor Glycemic Control

Both hypoglycemia and hyperglycemia can be detrimental to hospitalized patients. However, it is not clear which patients are more likely to develop significant problems with hypoglycemia or severe hyperglycemia in the hospital. Our hypothesis is that we will be able to identify risk factors present at admission that identify patients at greater risk of poor inpatient glycemic control


Eligibility Criteria:
Inclusion Criteria:

* age ≥ 18 years
* hospitalized in VUH

Exclusion Criteria:

* -length of stay \< 24 hours
* pregnant women
* patients receiving palliative/hospice care
A Drug-drug Interaction Study to Investigate the Effect of Coadministration of EDP-305 on the PK of a Combined Oral Contraceptive in Healthy Female Subjects

A Phase 1, Open-label, Fixed-sequence Study to Investigate the Effects of EDP 305 on the Pharmacokinetics of a Combined Oral Contraceptive in Healthy Adult Female Subjects


Eligibility Criteria:
Inclusion Criteria:

* Females of childbearing potential, 18 to 45 years of age, inclusive. Follicle-stimulating hormone levels may be used to confirm premenopausal status, including females who have had a hysterectomy with ovaries still intact. Women who otherwise meet inclusion criteria and who have had tubal ligation, tubal occlusion, or bilateral salpingectomy will be allowed.
* Body mass index between 18.0 and 32.0 kg/m2, inclusive.
* In good health, determined by no clinically significant findings from medical history, physical examination, 12 lead ECG, vital signs measurements, and clinical laboratory evaluations at Screening and Day -1 of the Lead-in Period
* Must not be pregnant or lactating, and must agree to use contraception
* Subjects must have documentation of normal results of up-to-date cervical cancer screening as specified in the American College of Obstetricians and Gynecologists guidelines:

  1. Women aged \< 21 years: no documentation required
  2. Women aged 21 to 29: normal Pap smear test result within previous 3 years
  3. Women aged 30 to 45: normal Pap smear test result and negative high-risk human papilloma virus test within previous 5 years, OR normal Pap smear test result within previous 3 years If documented results are not available at Screening, the subject must provide documentation of normal results prior to Day -1 of the Lead-in Period.
* Able to comprehend and willing to sign an ICF.
* Willing and able to adhere to assessments, prohibitions, and restrictions as described in this protocol.

Exclusion Criteria:

* Significant history or clinical manifestation of any metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, GI, neurological, respiratory, endocrine, or psychiatric disorder, as determined by the Investigator (or designee).
* Are pregnant, breastfeeding, or are planning to conceive during the study.
* Have been administered injectable contraceptives within 12 months prior to Day -1 of the Lead in Period, or had exposure to a hormonal intrauterine device or topical controlled delivery contraceptives (patch) within 3 months prior to Day -1 of the Lead-in Period.
S-Condom Uterine Tamponade in Controlling Atraumatic Postpartum Haemorrhage (PPH) - RCT

A Randomized Controlled Non inferiority Trial will be conducted to see the feasibility, acceptability and efficacy of S-Condom Uterine Tamponade in women with atraumatic PPH and not responding to first line of treatment.

A Randomized Controlled Non inferiority Trial will be conducted to see the feasibility, acceptability and efficacy of S-Condom Uterine Tamponade in women with atraumatic PPH and not responding to first line of treatment. The women will be divided randomly into two groups, in both groups two condom tied on a catheter will be introduced inside the uterus. In one group (Control group), condom will be inflated with saline and in another group(study group) it will be inflated with air. Time required to stop bleeding will be measured for comparison. Data collected will be analyzed using a quantitative approach and the results will be presented in tables and graphs. If air media proved feasible, acceptable and effective the PPH management will be easier, cost-effective can make a great impact in reaching the target for reduction of maternal mortality in Bangladesh and other resource poor settings.

Eligibility Criteria:
Inclusion Criteria:

* All women who presented with atraumatic postpartum hemorrhage, refractory to first-line treatment (uterine massage and oxytocin) and who will give their consent will be included in the study and will be randomized

Exclusion Criteria:

* Women known to have allergy to latex, or presenting with clinical chorioamnionitis or primary hemorrhage caused by cervical-vaginal lacerations, a uterine rupture, or a placenta accreta will be excluded.
Preoperative PSMA PET/CT As Triage for EPLND in Patients Scheduled for RALP (PrePSMA)

Extended pelvic lymph node dissection (ePLND) is considered the gold standard for nodal staging in men with prostate cancer (PCa). The aim of this project is to determine if preoperative prostate specific membrane antigen (PSMA) positron emission tomography (PET)/computed tomograpy (CT) can safely replace ePLND as a staging method in PCa patients undergoing robot-assisted laparoscopic radical prostatectomy (RALP).

Due to the latest change in EAU guidelines in May 2024, all eligible patients will undergo PSMA PET/CT. Patients will then be randomized between RALP and ePLND (Arm A) and RALP +/- ePLND (arm B): If PSMA PET/CT detect suspicious pelvic nodes, the patient will undergo ePLND concomitant with RALP. If PSMA PET/CT is negative, only RALP will be performed .

Primary outcome measures:

Difference in biochemical recurrence (BCR) rate between arm A and arm B within 2 years after initiation of primary treatment (BCR ≥ 0.2 ng/ml).

Secondary outcome measures:

Difference between Arm A and Arm B for surgical complications, persistent PSA after RALP and initiation of salvage therapy

Eligibility Criteria:
Inclusion Criteria:

* Biopsy proven diagnosed adenocarcinoma of the prostate
* Indication for ePLND combined with RALP:
* High-risk group (EAU) and including MRI findings indicating extra prostatic extension (Likert scale ≥4)
* -ISUP GG 3 with ≥1 of the following unfavourable risk factors

  * cT2b-c,
  * ≥50% percentage of positive biopsy cores,
  * PSA 10-20
* cN1 selected to surgery
* Written informed consent
* No known allergies for PSMA tracer
* 18 years and older

Exclusion Criteria:

* History of previously actively treated PCa
* Previous malignancies (except basal cell carcinoma of the skin) that has not been recurrence-free past ≥5 years
* Unwillingness or inability to undergo PSMA PET/CT and/or ePLND and RALP
* Presence of distant metastasis (cM1) on MRI imaging
Dosing Chart for Calculating the First Dose of Doxapram in Premature Infants

Doxapram is used to stimulate respiration. For a given dose, the fluctuations in concentrations observed in infants' blood may be wide, leading to a risk of lack of efficacy or of toxic effects. Two factors are linked to these fluctuations: age and gender. The aim of this study is to compare a dosage regimen based only on patient's weight, to another one using a dosing chart taking into account weight, age and gender.

Doxapram is a drug used to stimulate respiration in neonates prematurely born and failing to breathe. For a given dose, the fluctuations in concentrations of drug observed in infants' blood might be wide, leading to a risk of lack of efficacy of the treatment or of toxic effects. Two factors are linked to these fluctuations: age and gender. The aim of our study is to compare a dosage regimen based only on patient's weight, and another one using a dosing chart taking into account not only weight but also age and gender to prescribe the initial dose of doxapram. The final goal of this trial is to improve efficacy and tolerance of doxapram by minimizing the fluctuations in blood drug levels in premature neonates.

Eligibility Criteria:
Inclusion Criteria:

* Premature infants (\<37 weeks gestation)
* More than 1 significant Apnea q 8h (\> 20 sec or \< 20 sec with bradycardia or desaturation)
* Already treated with caffeine

Exclusion Criteria:

* Intubation
* congenital malformation
* symptomatic apnea
Effect of Global Postural Re-education in Idiopathic Scoliosis

In North America, children and adolescents with idiopathic scoliosis (IS) are rarely referred for a rehabilitation program whereas the European guidelines stated that scientific evidences concerning scoliosis specific physiotherapy exercises were strong enough to recommend the use of these exercises at an early stage. The objectives of this pilot study is to assess feasibility of conducting a larger randomized control trial (RCT) on the effect of global postural re-education (GPR) on scoliosis progression (Cobb angle) and posture, back pain and participation and to assess the equivalence of two groups of GPR interventions. A convenience sample of 60 adolescents with IS (Cobb angle 15º-50º, Risser sign ≤3) will be recruited at CHU Sainte-Justine. Participants will be randomly allocated to GPR-A (individual sessions once a week) or GPR-B (individual sessions once per two weeks alternately with class exercises once per two weeks) for 6 months. After 6 months, groups will be interchanged for another 6 months. Feasibility outcomes will be recruitment rate, consent rate, completion rate and adherence to treatment at 12 months. The primary outcome of the effect of GPR will be the Cobb angle. Secondary outcomes will be: posture, back pain and participation at 6 and 12 months. Statistical analyses: For feasibility, percentage of eligible patients recruited, percentage of recruited patients who completed the trial and adherence to treatment will be calculated. For the preliminary effects of GPR, linear mixed-models will be used to assess differences in groups' changes from baseline, to 6 and 12-month while adjusting for covariates (age, Risser, adherence). Separate analyses will be conducted for each outcome.


Eligibility Criteria:
Inclusion Criteria:

* aged between 8 and 16 years old,
* Cobb angle between 15º and 50º,
* a Risser sign ≤3 (skeletal growth incomplete),
* having recent x-rays (4-6 weeks),
* ability to travel weekly to attend GPR interventions

Exclusion Criteria:

* patients who are planning surgery or have had surgery,
* previous regular physiotherapy or other conservative treatment (chiro, osteopathy),
* worn a brace for at least three months prior to GPR interventions,
* scheduled for clinic follow-up later than in 6±2 months,
* or to be discharged before 12 months.
Targeted Hip Strength Training in Children With Cerebral Palsy (CP)

This study's main aim is to look at targeted strength training for muscles at the hips. Specifically to consider whether targeted strength training not only effects strength of the specific muscles but also ability to stand on one leg (single leg balance) as well as walking in children with cerebral palsy? This study is a feasibility of method of investigation.

This study is focusing on functional change. The reasoning is that if the targeted strength training is effective at improving hip muscle contribution to stability then single leg balance may be improved. This may be functionally evident when weight bearing is taken by say the left leg in gait (percentage stance phase of gait) and as a consequence the opposing swing phase will be optimised as measured by stride. Thus the research question is does strengthening of the rotating and sideways moving hip muscles improve the walking of children with CP as measured by appropriate aspects of gait? Secondly, does this targeted strengthening also increase duration of single leg balance which is a simple easy to use measure in the community without the need for specialised equipment? The primary outcome measure will use a laboratory based 4 camera Codsmotion (CODA) biomechanical analysis system to measure stride (a) and percentage duration of stance phase of gait (b). Secondarily the duration of single leg balance in terms of seconds will be recorded. Gross motor functional and quality of life as also being assessed. The intervention is strengthening which will be implemented with the principles of progressive resistance training. Children with CP's therapists would ask for this type of intervention to be carried out

Eligibility Criteria:
Inclusion Criteria:

* Children with CP aged between 7-16 years having sufficient cognition to undertake a strength training program

Exclusion Criteria:

1. non-ambulation children or those unable to walk 5 meters independently (without walking aid),
2. lower limb surgery within 12 months,
3. botox within 6 months,
4. oral muscle relaxant medication
5. significant learning difficulty
6. Any concurrent condition which would be contraindicated to progressive resistance training such as unmanaged high blood pressure, cardiac pathology or uncontrolled epilepsy
7. Where at baseline assessment finds no weakness in the muscles under investigation
8. concurrent or within 6 months involvement in any other research study
9. Non consent to General Practitioner (GP) notification.