cyrilzakka/clinical-trials huggingface dataset:
A Phase II Randomized, Double-Blind, Two-Period Cross-Over Study to Evaluate the Pharmacokinetics, Safety and Tolerability of a Liquid Formulation of Palizvizumab (MEDI-493, Synagis)

A total of 150 children who meet the entry criteria will be randomized 1:1 to receive one of the following treatment sequence A or B.

Phase II, Double-blind, two-period, cross-over study to be conducted at 20 sites the U.S. A total of 150 children who meet the entry criteria will be randomized 1:1 to receive one of the following treatment sequence: Sequence A (single dose of the liquid formulation on Study Day 0 and a single dose of the lyophilized formulation on Study Day 30) or Sequence B (single dose of the lyophized forumation on Study Day 0 and single dose of the liquid formulation on Study Day 30). Children will be followed for adverse events through 30 days after each injection of study drug and will have blood collected for determination of palivizumab concentrations in serum.

Eligibility Criteria:
Inclusion Criteria:

* The child must have been born at greater than or equal to 35 weeks gestation and be greater than or equal to 6 months of age at the time of randomization (child must be randomized on or before their 6-month birthday)
* The child's parent or legal guardian must provide written informed consent; and
* The child must be able to complete the follow-up visits on Study Days 30 and 60 within the protocol specified windows (±2 days)
* Parent/legal guardian of patient has available telephone access.

Exclusion Criteria:

* Be hospitalized;
* Birth hospitalization \> 6 weeks duration;
* Be receiving mechanical ventilation at the time of study entry (including CPAP);
* Bronchopulmonary dysplasia (BPD), defined as history of prematurity and associated chronic lung disease with oxygen requirement for \>28 days;
* Congenital heart disease (CHD). (Children with medically or surgically corrected \[closed\] patent ductus arteriosus and no other CHD may be enrolled.)
* Known renal impairment, hepatic dysfunction, chronic seizure disorder, or immunodeficiency;
* Any of the following laboratory findings in blood obtained within 7 days prior to study entry:
* BUN or creatinine \>1.5´ the upper limit of normal for age
* AST (SGOT) or ALT (SGPT) \>1.5´ the upper limit of normal for age
* hemoglobin \<9.0 gm/dL
* white blood cell count \<4,000 cells/mm3
* platelet count \<110,000 cells/mm3
* Acute illness or progressive clinical disorder;
* History of recent difficult venous access;
* Active infection, including acute RSV infection;
* Previous reaction to IGIV, blood products, or other foreign proteins;
* Received within the past 120 days or currently receiving IGIV, other immunoglobulin products, or any investigational agents;
* Have ever received palivizumab;
* Currently participating in any investigational study; or
* Previously participated in any investigational study of RSV vaccines or monoclonal antibodies.
Treatment of Osteomyelitis-associated Pressure Ulcers by Surgical Flaps and Anti-bacterial Agents

People with neuromotor disability (i.e. following an inborn or acquired spinal cord, cerebral or peripheral neurological lesion) are at high risk of osteomyelitis-associated pressure ulcers.

The management of osteomyelitis-associated pressure ulcers is controversial. In our center, patients benefit from a one stage surgical management with bone shaving and flap covering osteitis of pressure ulcer to perform wound closing. Surgery is followed by an antibiotic treatment, secondarily adapted to intraoperative samples.

The aim of this study is to describe the cohort and to identify factors associated with failure (or success) in this frail population.

This is a prospective, monocentric, cohort study of neurological disabled inpatients subjects treated in the perioperative disability unit (UPOH) of our university hospital for osteomyelitis-associated pressure ulcer by surgical flaps and anti bacterial agents.

All eligible inpatient subjects with neuromotor disability and admitted for the treatment of osteomyelitis-associated pressure ulcers by surgical flaps will be consecutively included.

Patients are followed up in consultation at 30 or 45 days after surgery, and in consultation or teleconsultation at 12 months after surgery.

Data will be collected from the patients' medical records, in particular data related to their clinical, radiological, biological, and physiological examinations. Data related to sitting, nutrition, spasticity, bladder and bowel disorders, bacteriological sampling and antibiotic treatments will be collected.

This is a routine care study; no procedures are added for research purposes. It is an ancillary study to the NO-AGING study.

Eligibility Criteria:
Inclusion Criteria:

* Patients \>= 18 years old ;
* Treated in the Perioperative Disability Unit (UPOH) of the Physical Medicine and Rehabilitation Department of our university hospital;
* Admitted for the treatment of an osteomyelitis-associated pressure ulcer by surgical flap;
* Having a neuromotor disability;
* No opposition to be enrolled in the study from the patient, or from a legally authorized close relative if the patient's state of health does not allow it;
* Affiliation to a social security scheme.

Exclusion Criteria:

* Under court protection.
Evaluation of Periapical Healing Following Endodontic Microsurgery With Leukocyte and Platelet Rich Fibrin (L-PRF)

The purpose of the study is to evaluate peri-radicular healing after root-end surgery using Leukocyte and Platelet Rich Fibrin. The study population includes patients diagnosed with persistent periapical pathology and scheduled for Endodontic Microsurgery at the University of Pennsylvania School of Dental Medicine, Department of Endodontics. Patients undergoing routine endodontic microsurgery and who meet the inclusion criteria will be given the opportunity to opt in to receive L-PRF in the osteotomy site to promote bone formation. Healing will be assessed radiographically and clinically at six, twelve, eighteen, and twenty-four months.


Eligibility Criteria:
Inclusion Criteria:

1. Provision of signed and dated informed consent form.
2. Stated willingness to comply with all study procedures and availability for the duration of the study, including the follow-up visits.
3. Male or Female age \>18 years old.
4. In good general health (ASA 2 or less) with no contraindications for Endodontic Microsurgery.
5. Persistent endodontic periapical pathology Class A, B, or C according to the Kim and Kratchman classification (5)
6. Intact coronal restorations with no evidence of leakage or caries under the restoration.

Exclusion Criteria:

1. Minors.
2. Suspected root fractures.
3. ASA classification 3 or greater.
4. Periapical pathology Class D, E, or F according to the Kim and Kratchman classification (5).
5. Patients with history of Oral or IV Bisphosphonate use.
6. Patients may be excluded if their treatment team do not believe Endodontic microsurgery and L-PRF graft is in the patient's best interests.
Rescue High Frequency Oscillatory Ventilation in Newborns Who Do Not Respond to Conventional Ventilation

Although High Frequency Oscillatory Ventilation (HFOV) has been used in case of unresponsive to conventional mechanical ventilation both in children and newborns, there is no data on its success and the factors that affect its success in the literature.

Although High Frequency Oscillatory Ventilation (HFOV) has been used in case of unresponsive to conventional mechanical ventilation both in children and newborns, there is no data on its success and the factors that affect its success in the literature.

The aim of the study is to define the factors that affect the success of HFOV in newborns who do not respond to conventional mechanical ventilation through an online registry among neonatal intensive care units in Turkey.

Eligibility Criteria:
Inclusion Criteria:

* patients switched to HFOV in case of unresponse to conventional ventilation
* stay on HFOV for at least 4 h

Exclusion Criteria:

* any congenital anomaly
* HFOV duration less then 4 h
Mental Imagery and Targeted Memory Reactivation in PTSD

With this protocol, investigators examine whether targeted memory reactivation (TMR), a technique used to strengthen memories, can accelerate remission of traumatic nightmares and post-traumatic stress disorder (PTSD) symptomatology. This protocol uses TMR during REM sleep to strengthen positive memories generated by Imagery Rehearsal Therapy (IRT), a recommended treatment of nightmares. Patients with PTSD are asked to perform 3 weekly IRT sessions and, while they generate a positive outcome of their recurrent nightmare, half of the patients are exposed to a sound S1 (TMR group), while the other half is not exposed to this sound (control group). All patients will perform IRT every evening at home and will be exposed to the sound S1 during REM sleep with a wireless headband, which automatically detects sleep stages. Clinical evaluation of the severity of PTSD and nightmares before and after (1-month follow-up and 3-months follow-up) this intervention takes place using the validated Clinically Administered PTSD Scale for DSM-5 (CAPS-5, primary outcome measure). The investigators hypothesize that patients treated with IRT and who are exposed, during REM sleep to a sound that had previously been associated with the new positive dream scenario of IRT (TMR group), will have more reduced frequency of PTSD severity and nightmares compared to participants with stimulation of the same, but non-associated, sound during REM sleep (control group).


Eligibility Criteria:
Inclusion Criteria:

* with untreated persistent PTSD according to DSM-5 (\> 1 month), suffering from chronic nightmares
* with no active specific treatment for PTSD

Exclusion Criteria:

* patients with active specific treatment for PTSD
* patients with neurological disorders
Prospective Evaluation of Patients With Uterine Cervical Cancer in Brazilian Health Institutions - The EVITA I Study

The primary objective of this study is to describe the socio-demographic, clinical pathological, quality of life and treatment characteristics of patients diagnosed with CC in Brazil.

The primary objective of this study is to describe the socio-demographic, clinical pathological, quality of life and treatment characteristics of patients diagnosed with cervix cancer (CC) in Brazil. Other specific objectives are:

* To describe socio-demographic characteristics: age at diagnosis, education, family income, race, occupation, personal health habits - e.g.oral contraceptive use ever/never and duration; smoking never/ever/current/duration , ever drinking), sexual history, insurance coverage (private, public), institution (private, public, philanthropic), obstetric history, comorbidities, performance status, human papillomavirus vaccination or not
* To describe the screening for CC: access, type, frequency and results.
* To describe clinical pathological characteristics of CC: histology (adeno x squamous x adenosquamous x neuroendocrine x other) , International Federation of Gynecology and Obstetrics (FIGO) stage, pathological stage, exams for staging, date of diagnosis, site of metastasis.
* To describe treatment characteristics of CC: date of surgery, type of surgery; date and duration of radiotherapy, type of radiotherapy; date, type and lines of systemic therapy (chemotherapy, monoclonal antibodies),
* To describe treatment safety (grade 3-4 AEs, death due to treatment toxicity, discontinuation due to AE). In addition adverse events of special interest will be described (details on Safety section).
* To describe the outcomes: follow-up exams and date of visits, persistent disease, recurrence, progression times in metastatic disease, complications (e.g. hydronephrosis/nephrostomy/ GI perforations and both GI \& genitourinary fistulae.), death due CC and death from any cause.

Eligibility Criteria:
Inclusion Criteria:

* Histologic confirmed invasive cervical cancer
* Diagnosis of FIGO stages
* Stage 1B to 2A high risk
* 2B-4B or recurrent disease
* Patients ≥18 years old

Exclusion Criteria:

1. Non-invasive uterine carcinoma;
2. Pregnancy;
3. synchronous tumor or second primary tumor in the past 5 years (except thyreoid ancer or non-melanoma skin cancer).
An Exploratory Study of HRD Score in Chinese Ovarian Cancer Patients Benefiting From PARP Inhibitor Targeted Therapy

This project intends to evaluate the sensitivity of different Homologous Recombination Deficiency (HRD) score to Poly(ADP-ribose) polymerase inhibitor (PARPi) by retrospectively analyzing the tissue samples of patients with ovarian cancer using PARPi, and to determine the cut off value of the HRD score algorithm suitable for the Chinese population, so as to provide evidence for the role of PARPi in ovarian cancer. The screening of the beneficiaries of maintenance therapy provides precise guidance and can be used as a reference for other cancer types.


Eligibility Criteria:
Inclusion Criteria:

1. age ≥ 18 years;
2. high-grade serous/endometrioid epithelial ovarian cancer, fallopian tube cancer or primary peritoneal cancer;
3. FIGO stage III or IV;
4. at least 6 cycles and no more than 9 cycles First-line platinum-containing chemotherapy;
5. CR or PR after chemotherapy;
6. ECOG 0-1;
7. sufficient biological samples for HRD score detection;
8. patients signed informed consent;
9. good bone marrow function.

Exclusion Criteria:

1. incomplete follow-up records of survival information;
2. unqualified biological sample quality control
Phase III Study of an Otic Formulation in Acute Otitis Media With Tympanostomy Tubes

The purpose of this study is to determine if a topical otic formulation is safe and effective in treating middle ear infections in patients with ear tubes.


Eligibility Criteria:
Inclusion Criteria:

* 6 months to 12 years old
* Ear tubes in one or both ears
* Ear drainage visible by the parent / guardian
* Ear drainage less than 21 days
* Ear tube may not be silver oxide, silver salt, t-type tube or long-shafted tube
* Patient may not have non-tube otorrhea
* Patient may not have had otic surgery other than tube placement in the last year
* Patient may not be a menarchal female
* Diabetic patients are not eligible
* Patient may not have any disease or condition that would negatively affect the conduct of the study
* Patient may not require any other systemic antimicrobial therapy during the study.
* Patient must meet certain medication washouts to be eligible
* Analgesic use (other than acetaminophen) is not allowed
* Patient may not be pre-disposed to neurosensory hearing loss
* Other protocol-defined inclusion criteria may apply

Exclusion Criteria:

* Age
* Other protocol-defined exclusion criteria may apply
Trial Comparing Metal Versus Plastic Stents for Preoperative Biliary Decompression

Compare the performance of full covered metal stents and plastic stents for preoperative biliary decompression

Covered self expandable metal stents (CSEMS) are three times larger in diameter than 10 Fr plastic stents. When compared to plastic stents, randomized trials have shown longer patency and fewer stent-related complications for CSEMS. The investigators hypothesize that placement of CSEMS would be a better treatment option for preoperative biliary decompression in patients with pancreatic cancer.

Eligibility Criteria:
INCLUSION CRITERIA:

1. Patients with pancreatic cancer and mass in the head of pancreas causing jaundice.
2. Patients 19 yrs of age and older
3. Serum bilirubin \> 2mg/dl
4. CT: No evidence of distant metastasis or local vascular invasion (tumor surrounding portal or mesenteric vessels for more than 180 degrees of their circumference or an irregular vessel margin).

EXCLUSION CRITERIA:

1. Karnofsky score \< 60
2. Prior (ERCP or PTC) attempts at biliary decompression for the same indication
3. Tumor-related gastric outlet obstruction (vomiting and oral intake of \< 1L/day)
4. Ongoing or planned neoadjuvant therapy
5. Cholangitis at presentation or coagulopathy needing reversal medication
6. Post-surgical anatomy
7. Multiple extra-hepatic biliary strictures or concomitant stricture in liver hilum
8. Failed ERCP's (Definition: Inability to deploy a biliary stent thereby requiring a PTC or surgery).
The Telemark Score: a Reliable Method for Evaluation of Results After Breast Surgery

This paper will present a specific tool for evaluation of cosmetic results after breast conserving surgery (BCS) and secondary breast reconstruction with free DIEP-flap. Introduction of a breast score system using digital photography seems to be a reliable tool for estimation of cosmetic results after breast surgery. The method has been employed on a specific group of 346 consecutive patients operated for breast cancer with breast conserving surgery. For the purpose of this study breast score system was tested on patients with free flap breast reconstruction (DIEP flap).

Background: Validated instruments for assessing results after breast surgery are sparse. Investigators want to present a method used for the past 10 years at their institution for evaluation of the outcome after breast conserving surgery (BCS) and microsurgical breast reconstruction. Methods: 346 consecutive patients subjected to BCS for cancer and 30 patients operated with a deep inferior epigastric flap (DIEP ) were assessed at least one year after the operation. The Telemark Breast Score is a method based on standard two-dimensional photographs assessing the outcome after breast surgery in terms of volume, shape and symmetry. Three different panels including plastic surgeons, breast surgeons and nurses were invited to test the Telemark Breast Score. Consistency of agreement between and inside the panel groups was studied Results: Inter- and intra observer reliability was acceptable. Good stability of ratings could be shown in test-retests.

Conclusion: The Telemark Breast Scale is inexpensive, statistically reliable and can be applied for quality control after breast surgery.

Eligibility Criteria:
Inclusion Criteria:

* Patients operated for breast cancer at Hospital of Telemark

Exclusion Criteria:

* Patients operated for breast cancer and not subjected for irradiation
The Efficacy and Safety of Low Dose Combination of LTG and VPA Compared to CBZ Monotherapy

To evaluate the efficacy of usual monotherapy and low dose combination of Lamotrigine and Valproate. Low dose combination may be more effective and tolerable because they are low dose and VPA reduce Lamotrigine metabolism.

An Open label, Randomized, Multicenter Clinical Trial to Compare the Efficacy and Safety of Lamotrigine / Valproate Coadministration and Carbamazepine as Initial Pharmacotherapy in Epilepsies

Eligibility Criteria:
Inclusion Criteria:

* Age ≥16yr old
* Who are diagnosed as epilepsy definitely
* Who have minimum 2 unprovoked seizures and minimum 1 seizure in previous 3 months
* Who need AED therapy and no AED medication for previous 1 year (exclude emergency medication for less than 2weeks)
* Who is not pregnant
* Who can report seizure diary by him/herself or caregiver
* Who agree to this trial and provide informed consent.
* Type of seizures : of generalized tonic-clonic, complex partial, and/or simple partial motor seizures;

Exclusion Criteria:

* Who has progressive CNS disease.
* Has serious systemic or psychiatric disease
* Who is not suitable by investigator(uncooperative)
* Who can not fill up diary check card
* Is pregnant, breastfeeding, or planning to become pregnant
* Exclusion - absence s. juvenile myoclonic epilepsy, atonic seizure, alcohol or other substance abusers, mental retardation etc.
* Who cancels to agree to this trial and provide informed consent.
* ALT, AST, bilirubin and BUN/Cr levels are more than twice normal range of them
* WBC value is 2000 and less, Hb value is 9.0 and less, platelet count is 100,000 and less in CBC
* Who took investigation products before participating this study
Two Formulations and Concentrations of Epinastine Nasal Spray Versus Azelastine Nasal Solution for Allergic Rhinitis

The objectives of this study were to:

* Examine the tolerability of two formulations and two dose concentrations of epinastine.
* Select formulation(s) of epinastine for future studies by evaluating the individual sensory attribute scores of the Nasal Spray Evaluation Questionnaire (NSEQ) collected after each study drug administration and the subject preference ranking assessed at the completion of the study.
* Compare the preference of two formulations and two dose concentrations of epinastine compared to azelastine following a single dose of each in a randomized, double-blind, two-cohort, three-period crossover design.


Eligibility Criteria:
Inclusion Criteria:

* between ages 18-70
* history of SAR or PAR for 1 year
* mild symptoms

Exclusion Criteria:

* asthma or RAD
* respiratory tract infection within 14 days prior to screening
DNA Biomarkers in Samples From Patients With Osteosarcoma and Healthy Volunteers

RATIONALE: Studying samples of blood and tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer.

PURPOSE: This research study is studying DNA biomarkers in samples from patients with osteosarcoma and healthy volunteers.

OBJECTIVES:

* To determine whether common copy-number alterations (CNAs) at chr7p14.1 arise de novo in osteosarcoma (OS) tumor DNA or whether they represent progression of constitutional copy-number variations (CNVs).
* To determine the association between constitutional CNVs at chr7p14.1 and susceptibility to OS.
* To determine how CNVs translate into CNAs in tumor DNA samples from patients with OS.

OUTLINE: RNA and DNA samples from banked blood and paired tumor tissue, plus samples from healthy controls, are analyzed for common copy-number alterations and constitutional copy-number variations (CNVs) at chr7p14.1 by microarray, q-PCR, RT-PCR, and FISH. Osteosarcoma predisposing CNVs results are then compared among cases versus healthy controls.

Clinical information associated with each osteosarcoma sample (i.e., gender, age of diagnosis, tumor site, tumor type and grade, presence of metastases at time of diagnosis, response to chemotherapy, event-free survival, and overall survival) is also collected, if available.

PROJECTED ACCRUAL: A total of 243 samples from patients with osteosarcoma and 80 samples from healthy controls will be accrued to this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Meets 1 of the following criteria:

  * Diagnosis of osteosarcoma (OS) and meets 1 of the following criteria:

    * Original 153 OS samples, including paired germline and tumor DNA
    * Additional samples from 90 patients with OS:

      * Blood samples
      * Germline DNA
      * Paired tumor biopsy tissue (not from resection) obtained before systemic chemotherapy
  * Healthy controls, age- and gender-matched

PATIENT CHARACTERISTICS:

* Not specified

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics