cyrilzakka/clinical-trials huggingface dataset:
MEOPA to Improve Physical Therapy Results After Multilevel Surgery

Children with cerebral palsy commonly undergo "multilevel surgery", meaning several lower limb combined procedures performed during the same surgical intervention. The aim of this type of surgery is to correct all deformities together in order to restore near to normal anatomy and muscular function. It is very important to be able to obtain good range of motion after surgery, in order to consolidate surgical results. During the first days after the operation, children are sore and it may be difficult to realize adequate physical therapy. In order to palliate this situation, MEOPA gaz is used during REHAB sessions. Good results have been obtained so far but no study is available to demonstrate these results. The goal of our research is to prove that there is a benefit in using MEOPA postoperatively in these patients.

The study is a randomized, single blinded, controlled clinical trial. It consist of two groups of patients: one group will receive MEOPA (FDA approval-"AMM" in France, 2003) and the other will receive medical air.

Results, in terms of articular range of motion, will be compared between groups after five sessions of REHAB. The following items will be evaluated: degree of pain, measured by a pain scale; joint ROM; number of sessions to obtain the desired results; parents, patients and caregivers satisfaction.

Patients aging from 6 to 20 years will be included if they meet selection criteria. Inclusions are confirmed before the first session starts. At this time, informed consent is to be signed by patients or parents and the Clinical Epidemiology Unit will assign a study number to the patient.

All patients get morphine therapy before the REHAB session; a new dose is administrated 10 minutes later if pain is higher than 4/10; ten minutes later, if pain is still over 4/10, MEOPA (or medical air) will be administrated. If this is not enough to diminish pain, the session will be interrupted. Five physical therapy sessions are provided after surgery, during inpatient time.

Knee ROM will be measured by goniometry and will be the measure of reference to evaluate the influence of MEOPA. Two types of pain scale will be used: analogical scale from 1 to 10 and faces scale (FPS-R) for small children.

For security reasons, the person who administrates de gaz will be informed of the nature of the product (MEOPA or medical air), the bottle will be masked and the therapist won't know what kind of product is being administrated.

Eligibility Criteria:
Inclusion Criteria:

* Multilevel surgery
* Spastic cerebral palsy

Exclusion Criteria:

* Patient not being able to walk
Burden of Illness in Atrial Fibrillation

The overall goal of this retrospective registry study is to investigate the burden-of.illness in atrial fibrillation (AF) in Denmark. Several Danish registries will be utilized to collect information on the diseases epidemiology including incidence and prevalence of AF and stroke as well as a stroke risk stratification of the Danish AF-population, the clinical and economical burden (in terms of direct and indirect cost) of AF and stroke to Danish patients, healthcare providers / healthcare system and society as well as describing treatment patterns with anticoagulant agents and their consequences in terms of stroke, bleeds, death and according cost in a real-life setting.


Eligibility Criteria:
Inclusion Criteria:

* Primary and secondary diagnosis with AF;
* The base population of AF patients will be identified in the National Patient Registry. For a given period of time (2000-2013, both years inclusive) all patients with a hospital contact (admission, outpatient visit or ER visit) and for whom AF was the primary or secondary diagnosis code (ICD10-code: DI480, DI481, DI482, DI483, DI484, DI489) will be included.

Exclusion Criteria:

* Patients younger than 18 and older than 90 years of age.
A Randomised Trial Using Highly Purified Human Chorionic Gonadotropin (HP-hCG) and Recombinant Human Chorionic Gonadotropin (rhCG) in Women Undergoing Controlled Ovarian Stimulation

This trial is investigating the efficacy and safety of highly purified human chorionic gonadotropin (HP-hCG) and recombinant human chorionic gonadotropin (rhCG) for triggering of final follicular maturation in women undergoing controlled ovarian stimulation


Eligibility Criteria:
Inclusion Criteria:

* Pre-menopausal females between the ages of 18 and 39 years
* Documented history of infertility
* Body mass index (BMI) between 17.5 and 32.0 kg/m2
* Regular menstrual cycles

Exclusion Criteria:

* Known endometriosis stage III and IV
* Known polycystic ovarian syndrome (PCOS)
* History of recurrent miscarriage
* History of more than three previous controlled ovarian stimulation cycles
Study of SPR001 in Adults with Classic Congenital Adrenal Hyperplasia

This is a multicenter Phase 2, multiple dose, dose escalation study to evaluate the safety, pharmacokinetics (PK), pharmacodynamics (PD), and efficacy of SPR001 in adult patients with classic congenital adrenal hyperplasia (CAH).

This is a 6-week, multiple-dose, dose escalation study of SPR001 for the treatment of adults with classic CAH. After screening, eligible patients will be enrolled into a 6-week treatment period followed by a 4-week washout/safety follow-up period.

It is initially planned that up to approximately 18 patients in 2 dose cohorts will be enrolled. Additional patients or dose groups may be considered based upon specific safety, PK/PD, and/or efficacy findings, or if an active dose has not yet been reached.

SPR001 will be administered as an oral daily dose. Patients will undergo titration of SPR001 through three escalating dosage strengths at 2-week intervals. Patients will have overnight PK/PD assessments performed at baseline, which include an pre-dose overnight assessment and a post-dose overnight assessment for PK/PD following administration of the first dose. At the end of each 2-week dosing period, patients will return for single overnight visits for steady-state PK/PD assessments.

A follow-up outpatient visit will occur 30 days after their last dose.

Eligibility Criteria:
Inclusion Criteria:

* Male and female patients age 18 or older.
* Documented diagnosis of classic CAH due to 21-hydroxylase deficiency
* Elevated 17-OHP at screening
* On a stable glucocorticoid replacement regimen for a minimum of 30 days

Exclusion Criteria:

* Clinically significant unstable medical condition, illness, or chronic disease
* Clinically significant psychiatric disorder.
* Clinically significant abnormal laboratory finding or assessment
* History of bilateral adrenalectomy or hypopituitarism
* Pregnant or nursing females
* Use of any other investigational drug within 30 days
* Unable to understand and comply with the study procedures, understand the risks, and/or unwilling to provide written informed consent.
Determination of Levels of Micafungin in Neonates Suffering From Systemic Candidiasis and/or Candida Meningitis

The primary purpose of this study is to evaluate the pharmacokinetic profile of micafungin administered to neonates suffering from systemic candidiasis. This study will also evaluate the proportion of success and of failure of the therapy with micafungin among treated neonates and will identify a conversion factor to relate plasma levels of micafungin into capillary and venous blood measured through blood samples from the heel and from a peripheral vein, collected simultaneously. Safety of micafungin in neonates will also be assessed.


Eligibility Criteria:
Inclusion Criteria:

* Infection by systemic candidiasis Systemic candidiasis is diagnosed in case of worsening of clinical conditions while on therapy with antibiotics, in case of isolation of candida from at least one sample collected from a normally sterile site (Blood, CSF, Urine, Peritoneal Fluid) and/or from at least two non contiguous sites (tracheal aspirate, gastric aspirate, faeces) and/or positivity to candida through polymerase chain reaction (PCR)(Septifast test), associated with at least one clinical symptom (fever or hypothermia, mottled skin, feeding difficulties, muscular hypotonia or hypertonia, apnoea crisis, bradycardia, tachycardia, hypotension, dyspnea, polypnea, desaturation) and one laboratory symptom (white blood cell \[WBC\] ≤5000/mm3 or WBC ≥20.000/mm3, immature to total neutrophil ratio \[I/T ratio\] \>2, Platelet count ≤100.000/mm3, C-reactive Protein \>0,5 mg/dL, Standard Base Excess \>-7 mmol/L, CSF pleocytosis-cells ≥ 6) and/or positivity to test Enzyme Linked Immuno-Sorbent Assay (ELISA) for the mannan antigen (≥125 pg/ml).
* Neonates affected by candida meningitis and/or hydrocephalus due to candida infection and/or bearing external ventricular derivation, until enrollment of at least 4 subjects with this characteristics.
* Parents of neonates, or legal representative, able to consent and comply with protocol requirements.
* Survival expectation not inferior to 3 days.

Exclusion Criteria:

* Acute hepatopathy (ammonium \> 200 µg/dL) or chronic hepatopathy.
* Known allergy or hypersensitivity to echinocandins or any of the excipients present in the formulation of the investigational product.
A Safety Study Using Pentamidine in Patients With Pancreatic Cancer Undergoing Standard Therapy

The purpose of this study is to investigate the safety and possible efficacy of the use of pentamidine in the treatment of pancreatic cancer metastasis in subjects receiving standard therapy.


Eligibility Criteria:
Inclusion Criteria:

* Histologically or cytologically proven diagnosis of advanced pancreatic adenocarcinoma that is unresectable or metastatic. At least one uni-dimensionally measurable lesion (on spiral CT scan)
* 18 years of age or older
* ECOG performance status 0, 1 or 2
* Serum aspartate transaminase (AST) serum alanine transaminase (ALT) £ 2.5 x upper limit of normal (ULN), or AST and ALT £ 5 x ULN if liver function abnormalities are due to underlying malignancy
* Total serum bilirubin £ 2 x ULN
* lipase within normal limits (1.5x ULN)
* Absolute neutrophil count (ANC) ≥ 1500/uL (1.5 x 109/L)
* Platelets ≥ 100,000/uL
* Hemoglobin ≥ 9.0 g/dL
* Serum creatinine £ 1.5 x ULN or calculated creatinine clearance ≥ 50 ml/min
* CA19-9 level ≥ 37 U/ml
* Normal ECG
* Signed and dated informed consent document indicating that the subject (or legally acceptable representative) has been informed of all the pertinent aspects of the trial prior to enrolment
* Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other trial procedures
* Life expectancy, in the opinion of the investigator, \> 3 months

Exclusion Criteria:

* BP \< 100 (systolic)
* History of uncontrolled renal disease, pancreatitis, or diabetes mellitus
* Peripheral sensory neuropathy (\> Grade 1, as per NCI CTCAE version 3.0)
* Concomitant therapy with other investigational agents or participation in another clinical trial within the previous 3 months.
* Any of the following conditions: Ongoing cardiac dysrhythmias of NCI CTCAE grade ≥ 2; atrial fibrillation of any grade; QTc interval \>450 msec for males or \>470 msec for females or uncontrolled intercurrent illness, e.g., unstable angina; severe coronary disease, ventricular arrhythmias, bradycardia \<50 bpm
* Active uncontrolled bacterial infection
* Concurrent use of drugs that could prolong QT interval
* Concurrent use of nephrotoxic drugs, including aminoglycosides, ampho B, foscarnet, cidofovir
* Concurrent use of drugs that may be associated with pancreatitis
* Concurrent active cancer originating from a primary site other than pancreas or history of cancer \< 3 years except for skin superficial bladder, uterus etc
* History of allergy or hypersensitivity to pentamidine
* Pregnancy or breastfeeding. All female patients with reproductive potential must have a negative pregnancy test (serum or urine) prior to first dose of study medication.
* Severe acute or chronic medical or psychiatric condition, or laboratory abnormality that would impart, in the judgement of the investigator, excess risk associated with trial participation of study drug administration, or which in the judgement of the investigator, would make the subject inappropriate for entry into this trial.
* On oral anticoagulants (LMWH is acceptable)
Propolis Effects in Patients With Chronic Kidney Disease

The aim of this study is to determine the impact of Propolis on proteinuria reduction and protection of the glomerular filtration rate in chronic renal failure patients.


Eligibility Criteria:
Inclusion Criteria:

* older than 18 years;
* less than 90 years;
* glomerular filtration rate between 25 and 70 ml / min;
* proteinuria in the urine 24 hours more than 300 mg or protein / creatinina in isolated urine greater than 0.3g / g or microalbuminuria (albumin / creatinine ratio) between 30-300 mg / g.

Exclusion Criteria:

* Pregnants;
* Neoplasia carrier;
* Renal transplant patients;
* Patients who refuse to participate in the study.
* Glomerulopathy on Immunosuppression
The Effect of Pomegranate (Punica Granatum L.) Peel Compress Application on Pain and Physical Function Status

Osteoarthritis is the most common type of arthritis among rheumatologic diseases. Complementary therapies are one of the effective methods for pain control. This study was planned as a randomized controlled experimental study. For this purpose, patients diagnosed with knee osteoarthritis who applied to the Orthopedics Outpatient Clinic will be included. It was calculated that the study would include at least 67 patients. The study will be collected using patient information form, descriptive characteristics form, Visual Analog Scale (VAS) and WOMAC osteoarthritis application scale. It was planned as a randomized controlled experimental study to evaluate the effect of pomegranate peel (P. granatum) compress application on pain and function status. The study was divided into 3 groups as Pomegranate (Punica granatum) peel compress, hot compress and control group. Pomegranate (Punica granatum) peel compress was applied 3 days a week for 3 weeks by turning the powder into porridge check.

This randomized controlled experimental study was conducted to evaluate the effect of pomegranate (Punica granatum) peel compress application on pain, stiffness and physical function in individuals with knee osteoarthritis.

Eligibility Criteria:
Inclusion Criteria:

* Visual analog scale score of 3 and above,
* those aged 45 and over,
* Diagnosed with knee OA by a physician according to the criteria of the American - Rheumatology Association (ARD),
* pain lasting at least 1 month or longer,
* not included in any physical therapy program during the research period, a
* capable of answering research questions,
* agreeing to participate in the research by giving verbal and written consent

Exclusion Criteria:

* with a defined psychiatric illness,
* having vision and hearing problems,
* diagnosed with complex disease such as malignant,
* having a wound in the application area,
* with a diagnosed vascular disease,
* the patient's other inflammatory disease such as rheumatoid arthritis, gout, fibromyalgia
* who have had serious trauma or surgery in the last 6 months,
* who have received DMARDS or intra-articular steroid injection therapy in the last 3 months
Single Dose Study To Study The Absorption, Metabolism And Excretion Of PF-04991532

The purpose of this study is to evaluate the excretion balance, metabolic profile and the routes of excretion of \[14C\]PF-04991532 in healthy adult male subjects.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male subjects between the ages of 18 and 55 years, inclusive (Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12-lead ECG and clinical laboratory tests).
* Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight \>50 kg(110 lbs).
* An informed consent document signed and dated by the subject.

Exclusion Criteria:

* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing) or clinical findings at Screening.
* History of irregular bowel movements (eg, irritable bowel syndrome or frequent episodes of diarrhea or constipation).
* Any condition possibly affecting drug absorption (eg, appendectomy, gastrectomy).
The Study of Percutaneous Mechanical Thrombectomy Treating Acute Deep Vein Thrombosis of Lower Extremities

This study is a prospective, multicenter, real world, observational study intended to understand tmechanical thrombectomy in the treatment of acute deep venous thrombosis of lower extremities, It is estimated that 600 patients with DVT were enrolled in the group at 24 centers nationwide from May 2022 to May2024. we can obtain data on the incidence of sequelae of deep venous thrombosis after PMT, and analyze the factors that may affect the efficacy of PMT.

Through inclusion and exclusion criteria, 600 patients were collected. This experiment was an observational study case series, and no control group was established. The patency of the lower extremity veins was assessed by lower extremity venous ultrasound or lower extremity venography. According to the postoperative symptoms and signs of the patients, the Villata score, (VEINS QoL)/Sym questionnaire and VCSS score were used to understand the PTS situation.Postoperative clinical follow-up was performed at 6 months, 12 months, 18 months, and 24 months. The main endpoints were the patency rate of lower extremity deep veins at 6 months after operation and the incidence of PTS (Villalta score) at 2 years after operation.

Eligibility Criteria:
Inclusion Criteria:

1. The symptoms of deep venous thrombosis of lower extremities occurred within 14 days (including 14 days)；
2. Lower extremity deep venous thrombosis involving iliac vein or / and femoral vein ;
3. Obtain the informed consent of all patients.

Exclusion Criteria:

1. Patients with a previous history of ipsilateral proximal lower limb deep venous thrombosis ;
2. patients who are prohibited from thrombolytic therapy;
3. inferior vena cava compression syndrome；
4. Allergic to heparin, low molecular weight heparin or contrast medium;
5. Patients who have participated in clinical trials of other drugs or medical devices that interfere with this clinical trial in the past 3 months;
6. Patients who do not want to participate in this trial;
7. Patients with poor compliance, or those who the researchers think are not suitable for selection.
Retention of CAD Metallic and Poly Ether Ether Ketone (PEEK) Frameworks

comparing retention of CAD CAM metallic and Poly Ether Ether Ketone (PEEK) partial dentures in Kennedy class I casses

partially edentulous patients with Kennedy class I classification will be recruited for the trial and then randomly distributed on two groups; experimental group will receive CAD CAM PEEK partial denture and control group will receive CAD CAM metallic partial denture. then primary impressions will be made and then mouth preparation followed by secondary impression then scanning of the master cast using extra-oral scanner then designing the partial denture using blender for dental then the frame work will be printed.

then frame work will be processed into either PEEK or Metal according to randomization.

retention will be measured at zero and 3 months.

Eligibility Criteria:
Inclusion Criteria:

- Patients with bilateral free end saddles in the mandible (kennedy class I) with last standing abutment premolar.

2- Opposing dentition is fully intact or restored. 3- Sufficient inter-arch space. 4- Angle's class I maxilla-mandibular relationship.

Exclusion Criteria:

1. Periodontal affection of the abutment teeth.
2. Skeletal mal-relation.
3. Unmotivated patients to maintain adequate oral hygiene to follow up.
4. Patients with neuromuscular and Psychiatric disorders.
5. Systematic disease affecting bone and periodontal health.
6. Insufficient inter-arch space.
7. Patients with physical reasons that could affect follow up.
Kidney Awareness Registry and Education

The purpose of this study is to evaluate the feasibility and acceptability of two different interventions aimed at improving health outcomes among patients with chronic kidney disease (CKD), who are at high risk of CKD progression. Specifically, this study will examine how best to implement a provider-level intervention (access to a CKD-registry) and a patient-oriented intervention (automated telephone self-management (ATSM) + health coach) on patient health outcomes, with a 2x2 factorial design.


Eligibility Criteria:
Inclusion Criteria:

* Patients with CKD (defined as estimated Glomerular Filtration Rate \< 60ml/min/1.73m2 or proteinuria consistently over 3 months) who speak English, Spanish or Cantonese and have a primary care provider

Exclusion Criteria:

* Kidney transplant recipients; pregnant women; individuals with an eGFR \<15 ml/min/1.73 m2; prevalent dementia; impaired cognition or severe mental illness; expected life expectancy \<6 months; no phone access; self-reported hearing impairment; severe visual impairment preventing use of a touch-tone telephone keypad; and non-study language
Study Will Assess Skin Irritation and Sensitization for HP-1050 Patch

A randomized, evaluator-blinded study to assess skin irritation and skin sensitization of HP-1050 transdermal system (HP-1050) in comparison to XULANE patch in healthy female volunteers.

This is a dual-center, evaluator-blinded, randomized phase 1 study evaluating skin irritation and skin sensitization of HP-1050 transdermal system in comparison to XULANE patch in healthy female volunteers. The study will consist of a 4-week Screening Phase and a Treatment Phase. The Treatment Phase will consist of the following periods: an Induction Period, a Rest Period followed by a Challenge Period and if needed, a Re-Challenge Period.

Eligibility Criteria:
Inclusion Criteria:

* Healthy non-pregnant, non-lactating females 18-35 years of age (inclusive0 and who are candidates for hormonal contraception;
* Subjects who have previously used hormonal contraceptives without complications or naïve subjects for whom hormonal contraceptives are not contraindicated in the opinion of the Principal Investigator;
* Subjects who are willing to stop using any current contraceptives for the duration of the study;

Exclusion Criteria:

* Subjects who are currently taking or have taken oral hormonal contraceptives within 30 days prior to the first patch application;
* Subjects who are currently using any long-acting hormonal method of contraception or has used them within the past 3 months;
* Subjects who have a contraindication for estrogen or norelgestromin, or subjects who have a history of sensitivity to estrogen or norelgestromin or any related derivatives;