cyrilzakka/clinical-trials huggingface dataset:
Effect of Peritoneal Lavage With Clindamycin-Gentamicin Solution & Oncologic Outcome

Antibiotic lavage reduces bacterial contamination and decreases SSI infection rate. SSI leads to an immunocompromised situation, leaving unattended the neoplasm. It has been described that SSI may result in a worse oncologic outcome.

Antibiotics combined with lavage have demonstrated a reduction in the bacterial contamination and decreases SSI infection rate. SSI leads to an immunocompromised situation, as immunologic defense is focused on controlling the septic focus, leaving unattended the neoplasm. It has been described that SSI may result in a worse oncologic outcome. The aim of this study is to evaluate prospectively the effect of peritoneal lavage with clindamycin and gentamicin on the oncologic outcome of colorectal tumours.

Eligibility Criteria:
Inclusion Criteria:

* diagnosis of colon neoplasms
* plans to undergo an elective surgery with curative aims

Exclusion Criteria:

* preoperative diagnosis of chronic renal failure (because of the risk of nephrotoxicity associated with intraperitoneal gentamicin absorption)
* allergy to gentamicin or clindamycin.
The Use of Airway Clearance Devices in ALS

The investigator is examining the use of one airway clearance medical device compared to the use of two airway clearance medical devices together in patients with amyotrophic lateral sclerosis (ALS). More specifically, the investigator wants to know how effective the use of either a mechanical High Frequency Chest Compression (HFCC) device is on its own or the use of both a mechanical High Frequency Chest Compression (HFCC) device and Cough Assist together to maintain a healthy airway and clear secretions.

The first device is a passive form of mechanical High Frequency Chest Compression (HFCC), which was designed to help clear the airway of mucus and other secretions through mechanical knocking of the chest area. The second device, called a Cough Assist, aids patients to clear mucus and secretions that they would otherwise be unable to clear with coughing. This study will enroll up to 20 people in total at CSMC.

This 180 day (25.7 weeks) pilot study is designed to evaluate the effectiveness of airway clearance devices in adults with ALS. Subjects will be randomized in a 1:1 ratio to one of two treatment groups: treatment with a mechanical HCFF device alone or treatment with both a mechanical HFCC device and a cough assist device.

This outpatient study includes a screening/baseline visit followed by a 180 day (25.7 weeks) treatment period with three scheduled clinic visits (day 30, day 90, day 180). Pulmonary assessments and ALS outcome measures will be collected at each visit in addition to quality of life assessments and device usage diaries.

Eligibility Criteria:
Inclusion Criteria:

1. Suspected, possible, probable, Probable (Lab-Supported), or Definite ALS according to El Escorial Criteria
2. Males and females age 18 and above
3. Novel to airway clearance device use
4. Forced vital capacity ≤ 75% of predicted

Exclusion Criteria:

1. Any contraindication for pulmonary ventilation scan including allergy to radioisotopes
2. Any contraindication for use of a pulmonary clearance device

   * Susceptibility to pneumothorax
   * Recent (within 30 days) barotrauma
   * Unstable head or neck injury
   * Active hemorrhage with hemodynamic instability
Diagnosis of Metastatic Tumors on 68Ga-FAPI PET-CT and Radioligand Therapy with 177Lu-EB-FAPI

FAP is a fibroblast activation protein and overexpressed in many tumor tissues. This study is intended to conduct preliminary clinical transformation and internal irradiation dosimetry research on 177Lu-EB-FAPI--a new 177Lu therapeutic drug modified by Evans Blue (EB) for the first time in the world.

Fibroblast activation protein (FAP) is a serine peptidase on the surface of tumor associated fibroblasts. It belongs to type II transmembrane glycoprotein. It is rich and characteristic expressed in tumor associated fibroblasts. It has special biological characteristics and stable genome. FAP is expressed at a high level in mesenchymal cells during the embryonic period and is inhibited shortly after birth. It is usually not expressed or expressed at a low level in the resting tissues of normal adults, but it is highly expressed in diseases related to tissue repair and matrix reconstruction, such as wound healing, inflammatory response, fibrosis and cancer It plays an important role in metastasis and immunosuppression.Currently, 68Ga labeled FAPI (68Ga-FAPI) has been successfully applied to a variety of tumor PET/CT imaging, including lung cancer, breast cancer, and gastrointestinal tract tumors.By modifying FAPI with Evans blue (EB) to form a new EB-FAPI, endogenous albumin can be used as a reversible carrier to prolong the retention time of drugs in the blood, thus increasing the targeted aggregation and retention of 177Lu-EB-FAPI in tumor cells, and effectively killing a variety of transplanted tumors with positive FAP expression.we'll try to assess the safety and therapeutic response to 177Lu-EB-FAPI in patients with metastatic tumors in human.

Eligibility Criteria:
Inclusion Criteria:

* confirmed treated or untreated metastatic tumors patients;
* 68Ga-FAPI PET/CT and 18F-FDG PET/CT within two weeks;
* signed written consent.

Exclusion Criteria:

* pregnancy;
* breastfeeding;
* any medical condition that in the opinion of the investigator may significantly interfere with study compliance
Study Evaluating The Safety And Tolerability Of Combination Therapy Inotuzumab Ozogamicin (CMC-544) And Rituximab

To assess the tolerability and the initial safety profile of Inotuzumab Ozogamicin (CMC-544) in combination with Rituximab in patients with B-Cell Non-Hodgkin's lymphoma (NHL).


Eligibility Criteria:
Inclusion Criteria:

* CD20 and CD22-positive, B-cell NHL which has progressed after 1 or 2 prior therapies.
* Prior therapy must have contained at least one dose of Rituximab therapy. Patients can not be refractory to Rituximab (refractory = PD under treatment or within 6 month
* Eastern Cooperative Oncology Group (ECOG) performance status: 0/ 1.
* Patients must not have received previous radioimmunotherapy.
* Patients tolerant to Rituximab.
* Patients must not have received chemotherapy, cancer immunosuppressive therapy, growth factors (except erythropoietin), or investigational agents within 28 days before first dose of test article.

Exclusion Criteria:

* Candidate for potentially curative therapies
* Subjects must not have received previous radioimmunotherapy.
* Subjects with autologous hematopoietic stem cell transplant within the last 6 months
PET/CT Scanning for the Follow-up of Antibiotic Treatment of Infectious Osteoarthritis in the Diabetic Foot

The investigators' primary objective is to assess the predictive power of PET/CT scanning in the evolution of infectious osteoarthritis of the diabetic diabetic after antibiotic therapy prescribed by national and international recommendations.


Eligibility Criteria:
Inclusion Criteria:

* The patient must have given his/her informed and signed consent
* The patient must be insured or beneficiary of a health insurance plan
* Patient has type I or type II diabetes
* Patient consulting in the department of Metabolic and Endocrine Diseases (Caremeau Hospital) or the department of Nutritional Diseases and Diabetology (Grau de Roi Medical Center) at the Nîmes University Hospital
* Patient has infected osteoarthritis of the foot according to the International Working Group on the Diabetic Foot with a probability \> 50% (score \>= 2).

Exclusion Criteria:

* The patient is participating in another study
* The patient is in an exclusion period determined by a previous study
* The patient is under judicial protection, under tutorship or curatorship
* The patient refuses to sign the consent
* It is impossible to correctly inform the patient
* The patient is pregnant
* The patient is breastfeeding
* Patient has severe sepsis or a stage 4 infection according to the international consensus on the diabetic foot
* Patient has severe renal insufficiency as defined by glomerular filtration rate \< 30ml/min/1.73 m\^2, calculated according to the MDRD equation, and is not undergoing dialysis
* Patient has a contra-indication for an MRI
* pacemaker
* intracranial clips
* metallic inclusions
* severe claustrophobia
Patient Satisfaction and Oral Health-Related Quality of Life of Quadrilateral Versus Bilateral Linear Bar Designs for Four Implant Implant-Assisted Complete Mandibular Overdenture Regarding Peri-Implant Crestal Bone Loss

For this study, twenty patients were selected, and participants were randomly divided into two groups using random numbers produced in an Excel spreadsheet. Each patient got four implants in the mandibular canine and first molar sites, as well as the bar attachment.

The purpose of this study was to document and report patient satisfaction with mandibular implant overdentures with quadrilateral distribution and linear distribution. The null hypothesis was that patient satisfaction would not be different depending on the distribution type (quadrilateral or linear).

According to the bar design, all patients were classified into two equal groups: quadrilateral bar design (group I) and bilateral linear bar design (group II). Peri-implant marginal bone loss was evaluated immediately (T0) and after 2 years (T2) of overdenture insertion using a digital periapical X-ray.


Eligibility Criteria:
Inclusion Criteria:

* have Angle's class I maxilla-mandibular relation
* sufficient inter-arch space
* a healthy, firm mucosa,
* enough residual alveolar ridges in the mandibular regions to support implants

Exclusion Criteria:

* neuromuscular disorder,
* excessive smoking,
* alcoholism,
* parafunctional habits
* systemic disorders affecting the bones
* history of head and neck radiation therapy.
Observation of Young Patients Who Are Undergoing Surgery for Craniopharyngioma

RATIONALE: Collecting information on how craniopharyngioma is diagnosed and treated may help doctors predict a patient's response to treatment and help plan the best treatment. It may also help identify the intermediate- and long-term effects of treatment.

PURPOSE: This clinical trial is collecting information on diagnosis, treatment, and quality of life of young patients who are undergoing surgery for craniopharyngioma.

OBJECTIVES:

Primary

* Identify all applied therapy strategies in pediatric patients with craniopharyngioma.
* Correlate relapse status with different therapy strategies/modality in these patients.
* Determine the health status (i.e., ophthalmologic, neuropediatric, and endocrine findings) and the health-related quality of life of these patients after treatment.

Secondary

* Determine the incidence of craniopharyngioma in pediatric patients.
* Identify quality control measures for diagnosis and therapy in these patients.
* Improve long-term care through a standardized follow-up program in these patients.
* Determine the efficacy of endocrine substitution for postoperative hypopituitarism in these patients.
* Identify risk factors for developing obesity and correlate the neurotransmitter concentration of leptin and neuropeptide Y in cerebral spinal fluid, serum, and craniopharyngioma cystic fluid with the likelihood of developing obesity in these patients.
* Determine the incidence and extent of eating disorders in these patients.

OUTLINE: This is a multicenter study.

Patients undergo neurologic, endocrine, and ophthalmologic tests and anthropometric diagnostic measurements. Patients then undergo 1 of the following surgical procedures: total resection; incomplete, subtotal, or partial resection; biopsy; or cyst pressure release. Patients whose tumor relapses may undergo a second resection and/or radiotherapy.

Quality of life is assessed at baseline and then periodically thereafter.

After surgery, patients are followed periodically.

PROJECTED ACCRUAL: A total of 120 patients will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Diagnosis of primary craniopharyngioma by MRI and CT scan (initial diagnosis)

  * Patients with only cystic sellar or parasellar malformation (e.g., Rathke pouch cysts or suprasellar cysts) are allowed but will undergo observation only

PATIENT CHARACTERISTICS:

Performance status

* Not specified

Life expectancy

* Not specified

Hematopoietic

* Not specified

Hepatic

* Not specified

Renal

* Not specified

PRIOR CONCURRENT THERAPY: Not specified
The Prognostic Significance of a Fragmented QRS Complex After Primary Percutaneous Coronary Intervention

To investigate the prognostic significance of a fragmented QRS (fQRS) complex in a patient who had undergone primary percutaneous coronary intervention (PCI).


Eligibility Criteria:
Inclusion Criteria:

* Patients with chest pain that continued longer than 30 minutes and with ≥ 2 mm ST elevation in ECG at least in two adjacent derivations were diagnosed with an acute STEMI. In all patients, at least two-fold increases were seen in serum CK-MB levels compared to normal values.Having acute STEMI for the first time was stipulated for inclusion in the study.

Exclusion Criteria:

* Subjects with known allergies to aspirin and clopidogrel, inadequate echocardiographic images, malignancy, a previous cerebrovascular event, renal dysfunction (creatine level \> 2.5 mg/dl), a previous MI, or a history of cardiogenic shock as well as those who refused to participate in the study were excluded.
RCT of CBT Combined With D-Cycloserine for Treating PTSD

The purpose of this study is to investigate if the effectiveness of cognitive-behavioral therapy for post-traumatic stress disorder can be increased by combining it with D-cycloserine (TCC/D-cycloserine) by comparing with a placebo (TCC/placebo).

Post-traumatic stress disorder (PTSD) is one of the most frequent anxiety disorder in the general population (Kessler and al., 2005). Currently, the treatment of choice for PTSD is cognitive-behavioral therapy (CBT; Foa, Davidson and Frances, 1999). Based on remission rates after treatment, successful outcomes of CBT for PTSD vary between 46 and 54 % when dropouts are considered, and between 56 and 70% among those who completed their therapy (Bradley and al., 2005). Thus, there is room for improvement.

Recently, the results of two published studies on the treatment of phobia of heights (Ressler and al., 2004) and social phobia (Hofman, 2006) indicated that the efficacy of CBT was increased by adding D-cycloserine. The superior efficacy of CBT/D-cycloserine over CBT/Placebo in the treatment of anxiety disorders can result from a greater release of glutamate, a substance facilitating the extinction of fear (Davis, Myers, Ressler and Rothbaum, 2005; Richardson, Ledgerwood an Cranney, 2004). However, to our knowledge, no study has yet compared CBT/D-cycloserine to CBT/Placebo in the treatment of PTSD. The main hypothesis of the current study is that the efficacy of CBT for PTSD will be increased when combined with D-cycloserine compared to a placebo.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of PTSD
* No other Axix I disorder of higher intensity than PTSD
* Accept not to start a psychopharmacological treatment before and during the participation to the project

Exclusion Criteria:

* Substance abuse
* Psychotic episodes (past or current)
* Bipolar disorder
* Organic caused mental disorder
* Intellectual deficiency
* Pregnant or breast-feeding woman
* Épilepsy
Clinical Evaluation of the Next Science SurgX Antimicrobial Wound Gel Impact on Surgical Site Complications

This is a single-site, prospective, clinical study of subjects that are scheduled to undergo either total hip or total knee arthroplasties. It is anticipated that surgical wounds treated with SurgX will exhibit reduced surgical site complication rates and improved post-operative treatment outcomes by potentially decreasing site bioburden of both free-floating and biofilm-entrenched organisms.


Eligibility Criteria:
Inclusion Criteria:

1. Male or female 18 years or older
2. Scheduled to undergo primary hip or knee arthroplasty
3. Willing and able to comply with all study procedures and be available for the duration of the study
4. Provide signed and dated informed consent

Exclusion Criteria:

1. Unable to provide signed and dated informed consent
2. Unable or unwilling to comply with all study-related procedures
3. Known history of allergic reaction to any of the study products or its components, including any products used for standard of care (such as dressings or any coverings)
4. Subject with any mental impairment or condition that would make them unable to properly consent without use of LAR or additional subject protections
5. Subjects from a vulnerable population, in accordance with 45 CFR 46 Subparts B, C, and D
Bevacizumab in Combination With Metronomic Temozolomide for Recurrent Malignant Glioma

This is a phase II study of the combination of Avastin and metronomic temozolomide in recurrent malignant glioma patients. The primary objective will be to determine the efficacy of Avastin (bevacizumab) and metronomic temozolomide in malignant glioma patients. The secondary objective will be to determine the safety of Avastin, 10 mg/kg every other week, in combination with metronomic temozolomide in terms of progression-free survival.

This is a phase II trial of the combination of Avastin and metronomic temozolomide in recurrent WHO grade IV malignant glioma patients. Patients will receive up to 12 cycles of Avastin and temozolomide and cycles are continuous 28 days. Patients will receive daily temozolomide at a dose of 50mg/m2 and will receive Avastin every other week at a dose of 10mg/kg. Patients will be required to have a baseline MRI within 2 weeks of starting treatment and a repeat MRI every 8 weeks. A total of 32 patients will be enrolled at Duke.

Patients with recurrent malignant gliomas have a very poor prognosis, so new therapies are needed. Given the activity of metronomic temozolomide and the safety and activity of Avastin against malignant glioma, it is reasonable to study the combination in recurrent malignant glioma patients.

Eligibility Criteria:
Inclusion Criteria:

* Patients must have histologically confirmed diagnosis of WHO grade IV primary malignant glioma
* Karnofsy Performance Status (KPS) \>/= 60%
* Evidence of measurable primary CNS neoplasm on contrast-enhanced MRI.
* An interval of at least 4 weeks between prior surgical resection or 1 week from a biopsy and enrollment on this protocol
* An interval of at least 4 weeks from the end of prior radiotherapy or one week from the end of a cycle of chemotherapy and enrollment on this protocol.
* No evidence of CNS hemorrhage on the baseline MRI or CT scans

Exclusion Criteria:

* Life expectancy \< 8 weeks
* Pregnancy or breast feeding
* Progression to metronomic temozolomide, defined as tumor progression while taking daily temozolomide or progression within 4 weeks of stopping metronomic temozolomide
* Inadequately controlled hypertension (defined as systolic blood pressure \>150 and/or diastolic blood pressure \> 100 mmHg on antihypertensive medications)
Monitor the Incidence of Congenital Malformations in Infants of Women Who Have Been Treated With Ganirelix (Orgalutran®)(Study 38644)(P05966)(COMPLETED)

The primary purpose of this study is to collect data on the incidence of congenital malformations in infants of women with an ongoing pregnancy after controlled ovarian stimulation with recombinant follicle stimulating hormone /ganirelix followed by in vitro fertilization (IVF) or intra cytoplasmatic sperm injection (ICSI), and to compare this incidence with that of a group of women who used a long protocol with a gonadotropin releasing hormone agonist as historical controls.


Eligibility Criteria:
Inclusion Criteria:

* Puregon® (recFSH)/Orgalutran® group:

  * Women with a pregnancy of \>= 16 weeks after Puregon® /Orgalutran® treatment for IVF or ICSI and ET of fresh embryos. Treatment is defined as having had at least one injection of Orgalutran®.
  * Women between 18 and 39 years of age (inclusive) at the day of hCG.
  * Women who are able and willing to sign informed consent.

Controls

* Infants (gestational age \>=16 weeks) of women pregnant after COH using a GnRH agonist in a long protocol for IVF or ICSI and ET of fresh embryos.
* Infants of women between 18 and 39 years of age (inclusive) at the day of hCG.
* The most recent 1000 infants delivered prior to January 1, 2001.

Exclusion Criteria:

* None
Effect of Prenatal Education on Perceptions of Epidural Acceptance

The purpose of the study is to determine if targeted prenatal educational program on womens' perceptions of epidural increases the acceptance of intrapartum epidural analgesia relative to the control group.

Racial/ethnic disparities exist in the proportion of patients receiving epidural analgesia. The purpose of our study is to determine if culturally-sensitive educational program targeting womens' perceptions of epidural increases the acceptance of intrapartum epidural use.

Eligibility Criteria:
Inclusion Criteria:

1. Women with viable intrauterine gestation seeking prenatal care
2. Candidates for Intrapartum epidural analgesia

Exclusion Criteria:

1. Intrapartum epidural analgesia is contraindicated
2. Trial of labor is contraindicated.
3. Patients planning an elective cesarean
Can Total Mechanical Power Be a Determinant of Weaning Failure in Chronic Obstructive Pulmonary Disease (COPD)?

A Comparison of Ventilator Parameters (TV, DP, Total Mechanical Power, etc.) Between Successfully and unsuccessfully Weaned Patients with COPD Undergoing Mechanical Ventilation Due to Respiratory Failure, and Diagnosed with Pneumonia or ARDS in the Intensive Care Unit."

The objective of this study is to investigate which mechanical ventilation parameters and clinical findings influence weaning success by comparing successful and unsuccessful weaning patient groups among patients diagnosed with COPD who were intubated and monitored for more than five days in the intensive care unit. The findings of this study may contribute to the development of future treatment protocols and criteria for evaluating the weaning process.

This study is planned to be conducted in two centers: Bakırköy Dr. Sadi Konuk Training and Research Hospital in Istanbul and Shahid Beheshti University of Medical Sciences, Masih Daneshvari Hospital in Tehran. This multicenter study aims to facilitate the comparison of data obtained under different geographical and clinical conditions, thereby enabling a broader analysis of factors influencing the weaning process across a larger patient population.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged 18 years and older
* COPD-diagnosed patients who have been intubated and stayed in the ICU for more than 5 days

Exclusion Criteria:

* Patients without electronic medical records
* Patients under 18 years of age
* Patients diagnosed with pulmonary malignancy
* Patients who stayed in the ICU for less than 5 days
* Patients monitored in the ICU without intubation
OSHES - Observational Study on Hemostasis in Surgery (TC-022-IT)

OSHES (= Observational Study on Hemostasis in Surgery) is a non interventional register settled in Italy with the purpose of collecting data on 800 patients intra-operatively treated with hemostatic supporting agents/techniques in addition to the standard surgical procedures in 40 surgical wards. The availability of these data will allow for a better understanding of the therapeutic needs in the area of hemostatic supporting agents/techniques.


Eligibility Criteria:
Inclusion Criteria:

* Patients who are candidates for a specific type of surgery where a supportive hemostyptic agent will be used and who issued an informed consent. A special procedure will be implemented for use in emergency situations.