cyrilzakka/clinical-trials huggingface dataset:
Utility of Intra-operative Image Guidance System for Missing Metastases

Intraoperatively, the surgeon will interrogate the liver with ultrasound. The time spent by the surgeon using the ultrasound is recorded. If all lesions seen on pre-op imaging were found, the patient does not have the Pathfinder Explorer system applied. If one or more lesions cannot be found, then the Pathfinder Explorer system is calibrated and a tracking device is attached to the ultrasound probe, which the surgeon will use to reattempt localization of the missing tumor. The Pathfinder Explorer system operates in real-time in conjunction with the ultrasound.


Eligibility Criteria:
Inclusion Criteria:

* patient has one or more colorectal liver metastases, at least one of which is ≤1.5cm in maximal diameter on pre-operative cross sectional imaging
* undergoing liver resection and/or ablation

Exclusion Criteria:

* none
A 26-Week Study to Evaluate the Efficacy and Safety of Tenapanor in IBS-C

This phase 3, 26-week, randomized, double-blind, placebo-controlled, multi-center study will evaluate the safety and efficacy of one dose of Tenapanor in subjects with constipation-predominant irritable bowel syndrome (IBS-C) as defined by the ROME III criteria and who have active disease as determined after a two-week screening period. Subjects who qualify and are randomized into the study will either receive 50mg BID of Tenapanor (1:1) for a 26 week treatment period.

During the 26-week double-blind treatment period, subjects will record daily assessments including: frequency and timing of bowel movements; sensation of complete bowel emptying; consistency of bowel movements; degree of straining, worst abdominal pain, abdominal discomfort, abdominal bloating, abdominal fullness and abdominal cramping; and use and timing of rescue medication. Subjects will also record weekly assessments including: adequate relief of IBS symptoms, degree of relief of IBS symptoms, IBS severity, and constipation severity.

Eligibility Criteria:
Inclusion Criteria:

* Males or females aged 18 to 75 years, inclusive
* Females must be of non-childbearing potential; If of child-bearing potential, must have negative pregnancy test and confirm the use of one of the appropriate means of contraception
* Males must agree to use appropriate methods of barrier contraception or have documented surgical sterilization
* Subject meets definition of IBS-C using Rome III Criteria for the Diagnosis of IBS
* A colonoscopy based on AGA guidelines; every 10 years at ≥50 years old

Exclusion Criteria:

* Functional diarrhea as defined by Rome III criteria
* IBS with diarrhea (IBS-D), mixed IBS (IBS-M), or unsubtyped IBS as defined by Rome III criteria
* Diagnosis or treatment of any clinically symptomatic biochemical or structural abnormality of the GI tract within 6 months prior to screening, or active disease within 6 months prior to screening; including but not limited to cancer, inflammatory bowel disease, diverticulitis, duodenal ulcer, erosive esophagitis, gastric ulcer, pancreatitis (within 12 months of screening), cholelithiasis, amyloidosis, ileus, non-controlled GERD, gastrointestinal obstruction or carcinoid syndrome.
* Potential CNS cause of constipation (e.g., Parkinson's disease, spinal cord injury, or multiple sclerosis)
* Subject has a history or current evidence of laxative abuse (in the clinical judgment of physician)
* Hepatic dysfunction (ALT \[SGPT\] or AST \[SGOT\] \>2.5 times the upper limit of normal) or renal impairment (serum creatinine \>2 mg/dL)
* Any evidence of or treatment of malignancy (other than localized basal cell, squamous cell skin cancer or cancer in situ that has been resected) within the previous year
* Any surgery on the stomach, small intestine or colon, excluding appendectomy and cholecystectomy (unless within 60 days of screening visit)
Study for Evaluation of Efficacy and Safety of SH L 749 to Indolent B-cell Non-Hodgkin's Lymphoma

The purpose of this study is to investigate the antitumor effect and safety of the product for relapsed or refractory indolent B-cell non-Hodgkin's lymphomas.

The study has previously been posted by Schering AG, Germany. Schering AG, Germany has been renamed to Bayer Schering Pharma AG, Germany.Bayer Schering Pharma AG, Germany is the sponsor of the trial.

Eligibility Criteria:
Inclusion Criteria:

* Platelet counts of \>/= 100,000/mm3
* Absolute neutrophil counts of \>/= 1,200/mm3
* Bone marrow involvement \< 25%

Exclusion Criteria:

* Patients who received hematopoietic stem cell transplantation, including bone marrow transplantation, peripheral blood stem cell transplantation, etc.
* Patients presenting with marked bone marrow hypocellularity (any suspected bone marrow hypocellularity should be confirmed by bone marrow biopsy)
* Patients with previous myocardial infarction within the past 1 year, with heart disease that requires treatment or with pulmonary dysfunction
* Patients with serious concomitant diseases (cardiac failure, renal failure, etc.)
Effect of FGM on Glucose Control in Diabetic Patients

The aim of the study is to assess the eﬀect of FGM on glycemic control compared with SMBG using a randomised controlled study design in adults with type 2 diabetes.

Flash glucose monitoring (FGM) is a newly introduced Glucose Monitoring system. The aim of the study is to assess the eﬀect of FGM on glycemic control compared with standard blood glucose monitoring (SMBG) using a randomised controlled study design in adults with type 2 diabetes. Subjects will use unmasked FGM once a month or SMBG to monitor glucose level for 3 months. Patients in the SMBG group will wear masked FGM to collect glycaemic variability data for comparison to the intervention group of the study. The primary outcome, HbA1c, will be cpmpared at baseline and 3 month. Glucose control parameters provided by unmasked and masked FGM will be compared in the two groups, including mean blood glucose (MBG), coefficient of variation (CV), area under the curve (AUC), Time in Range(TIR), etc.

Eligibility Criteria:
Inclusion Criteria:

1. \>18 years old;
2. diagnosed as having diabetes who were willing to perform the study and complete the data collection;
3. in stable condition prior to the study.

Exclusion Criteria:

1. pregnancy or attempting to conceive;
2. known allergy to medical grade adhesive or isopropyl alcohol used to prepare the skin;
3. skin lesions, scarring, redness, infection, or edema at the sensor application sites;
4. patients whose conditions were extremely severe and not stable.
Safety Study of OXi4503 (a Vascular Disrupting Agent) Given by 3 x Weekly Intravenous Infusions to Patients With Advanced Solid Tumors

The purpose of this study is to establish the Maximum Tolerated Dose (MTD) of OXi4503 given by weekly infusions to patients with advanced solid tumors.


Eligibility Criteria:
Inclusion Criteria:

* Histologically proven cancer.
* Written informed consent.
* Age \>/= 18 years.
* Life expectancy of at least 12 weeks.
* World Health Organization (WHO) performance status of 0 or 1.
* Adequate Hematological and biochemical indices to support investigational therapy.
* All women of childbearing potential (WOCBP) must have a negative serum pregnancy test.
* WOCBP and fertile men and their partners must agree to use an effective form of contraception during the study and for 90 days after the last dose of study medication.
* Measurable and evaluable disease.
* All toxic manifestations of previous treatment must have resolved.
* Able to undergo MRI scanning.

Exclusion Criteria:

* Radiotherapy, endocrine therapy, immunotherapy or chemotherapy during the previous four weeks (six weeks for nitrosureas and Mitomycin-C) prior to treatment.
* Pregnant and lactating women.
* Major thoracic and/or abdominal surgery in the preceding four weeks from which the patient has not yet recovered.
* Patients which have active uncontrolled infections.
* Patients with any other condition that in the Investigator's opinion would not make the patient a good candidate for the clinical trial.
* Patients known to be serologically positive for Hepatitis B, Hepatitis C or Human Immunodeficiency Virus (HIV).
* Previous or ongoing cardiac conditions.
* Uncontrolled hypertension.
* Patients taking any drug known to prolong the QTc interval.
* Patients who have had any ischaemic or vascular damage from previous radiotherapy.
* Patients taking warfarin or heparin.
* Patients taking naproxen.
* Patients taking supplements or multivitamins containing vitamin C.
* Patients should not be taking any other investigational drug for the duration of the study.
* Patients with brain metastases or neurological tissue involvement of the spinal column.
Vertebral Bone Marrow Clot for Spinal Surgery

Spinal fusion (SF) is a common orthopedic procedure to treat spinal diseases. Apart from fixation systems, the procedure requires bone grafting to further improve SF. Cell-based therapies as vertebral bone marrow aspirate (vBMA) with bone allograft were developed as alternative to bone autograft in SF. However, vBMA use is limited by the lack of a standardized procedure, of a structural texture and by the possibility of diffusion away from the implant site. Recently, the potential use of a new formulation of vBMA, named vBMA clot, has been described. The project aims at evaluating the clinical evidence and the biological features of vBMA clot associated to bone allograft for SF surgery, considering age and gender related differences. A randomized controlled trial will prove the efficacy of the treatment and advanced preclinical studies will improve the knowledge on vBMA clot regenerative and anti-inflammatory properties, exploring for the first time its antibacterial characteristics.

To evaluate the efficacy of autologous vBMA clot in SF procedures in patients with degenerative spine diseases, a randomized controlled trial (RCT) will be carried out. The study will compare patients treated with autologous vBMA clot associated to bone allograft chips versus bone allograft chips alone (standard treatment), also evaluating whether patient age and gender are associated with differences in the clinical outcomes.

Eligibility Criteria:
Inclusion Criteria:

* degenerative spinal disorders (based radiological diagnosis)
* posterior spinal stabilization ≤ 5 levels
* age between 18-80 years at the time of surgery

Exclusion Criteria:

* HIV
* HBV
* HCV
* coagulations disorders
* pregnant or breast-feeding women
* cancer
* infections
* previous spinal surgery
* radio- chemotherapy
* myeloproliferative disease
* chronic steroid medication, thyroxin, immunodepression
A Study to Evaluate the Safety and the Activity of S095029 as Part of Combination Therapy in Advanced Gastroesophageal Junction/Gastric Cancers.

This study will investigate the safety, tolerability, and antitumor activity of S095029 (anti-NKG2A antibody) in combination with pembrolizumab in in microsatellite instability-high/Defective mismatch repair (MSI-H/dMMR) locally advanced unresectable or metastatic gastric /GEJ adenocarcinomas.

This Phase 1b/2 study will be conducted in two parts; a safety lead-in part (Phase 1b) to identify the RP2D of S095029 in combination with pembrolizumab and an expansion part (Phase 2) to evaluate anti-tumor activity and safety in participants with locally advanced unresectable or metastatic MSI-H/dMMR gastric /GEJ adenocarcinomas.

Eligibility Criteria:
Inclusion Criteria:

* Have a confirmed diagnosis of locally advanced and unresectable or metastatic gastric or gastro-esophageal junction adenocarcinoma
* Participants' tumor must have an MSI-H/dMMR status according to institutional guidelines and/or according to the College of American Pathologists, determined at any time prior to enrolment.

Exclusion Criteria:

* Has received more than one previous line of treatment in the locally advanced and unresectable or metastatic setting.
* Has received prior therapy with any checkpoint inhibitor (anti-PD-1, anti-programmed cell death ligand 1 (PDL1), anti-CTLA4).
* Participants who have received prior systemic anti-cancer therapy including investigational agents within 4 weeks (shorter interval, at least 5 half-lives, for kinase inhibitors or other short half-life drugs) prior to first study treatment.
* Prior radiotherapy if completed less than 2 weeks before first study treatment
* Major surgery less than 4 weeks prior to the first study treatment or participants who have not recovered from the side effects of the surgery.
Evaluation of a Youth Mentoring Program

This study will be used to determine the effectiveness of GirlPOWER!, an innovative mentoring program for adolescent minority girls living in urban areas.

The potential benefits of adolescent mentoring programs cannot be overemphasized. Mentoring may be especially beneficial to urban-living, minority adolescents who may lack role models. The Big Brothers Big Sisters (BBBS) organization administers a widely-praised and empirically-supported program that is committed to building successful mentoring relationships between adolescents and adults in their community. In collaboration with the BBBS affiliate agency in Chicago, the PI has developed an intervention called GirlPOWER! GirlPOWER! combines mentoring with self-esteem enhancement and health education and promotion strategies. This study will determine the effectiveness of the GirlPOWER! intervention and determine its feasibility in being applied to other populations.

Participants will be randomly assigned to receive either the GirlPOWER! intervention or traditional mentoring through BBBS and followed for 1 year. Participants in the GirlPOWER! group and their mentors will engage in structured activities that focus on strengthening the mentoring relationship, promoting self-esteem, reducing levels of health-compromising behaviors such as substance use and violence, and increasing levels of health-enhancing behaviors. Traditional mentoring comprises less structured activities and typically includes general discussion of an adolescent's day-to-day life and any accomplishments and challenges he or she may have experienced. Participants will be assessed at study entry, 3 months following entry, and at the end of one year. Assessments will include surveys completed by youth as well as their parents, mentors, and teachers; academic data also will be obtained from school records.

Eligibility Criteria:
Inclusion Criteria:

* Live in Chicago, Illinois Metropolitan area
* Parent or guardian willing to provide informed consent

Exclusion Criteria:

-Significant cognitive limitations or behavioral concerns that would preclude ability to participate appropriately in the intervention
Study to Evaluate the Clinical Impact of a Laparoscopic Radical Prostatectomy Simulator

To evaluate the clinical impact of an online video simulator during the learning period of laparoscopic radical prostatectomy.

Objectives: To compare two different approaches in learning laparoscopic radical prostatectomy , with or without using an online video simulator Design : Prospective randomized multicentric study

Methods: 20 surgeons considered as naive concerning their experience in laparoscopic radical prostatectomy will be randomized into two groups :1 group will use the online video simulator, 1 group will use usual learning methods except the online video simulator.

All procedures will be recorded from the beginning till the end.A video review will be preformed concerning all the videos in order to identify the total operative time and time to perform each one of the operative steps of the procedure.Clinical , biological and histological data will be collected in order to compare the two arms.

Eligibility Criteria:
Inclusion Criteria:

* Surgeon beginning his clinical experience in laparoscopic radical prostatectomy and having performed less then 30 procedures before being enrolled in the study
* Surgeon who intends to begin laparoscopic radical prostatectomy clinical practice
* Surgeons who usually perform enough cases to enroll at least 10 patients during the study inclusion time

Exclusion Criteria:

* Surgeon who does not have access to high speed internet (\>1024 Ko/s)
* Surgeons who do not intend to begin laparoscopic radical prostatectomy in his clinical practice
Reducing Youth Access to Firearms Through the Health Care Setting

The purpose of this project is to examine the implementation and effectiveness of an intervention, delivered in a health care setting, to decrease home firearm access by youth. The investigators hypothesize that:

1. parents who receive means restriction education provided by their primary care provider will be more likely to report, at the one month and one year follow-up, that they are storing their guns locked compared to parents who do not receive means restriction counseling.
2. parents who receive a free gun locking device(s) will be more likely to report, at the one month and one year follow-up, that they are storing their guns locked compared to parents who receive means restriction counseling alone;
3. parents whose adolescents are assessed at high risk for violence (\> 5 on the Violence Injury Protection and Risk Screen (VIPRS)) or depression (\>9 on the Patient Health Questionnaire-9 (PHQ-9)) will be more likely to report storing their gun(s) locked at the one month follow-up compared to parents whose children are assessed as low risk, regardless of whether they receive the counseling alone or counseling plus free locking devices and 4) youth whose parents receive a free gun locking device(s) will be more likely to report less access to guns, at one year follow-up, compared to parents who receive means restriction counseling alone.


Eligibility Criteria:
Inclusion Criteria:

* Patient at the Children's Hospital Colorado in the Adolescent Medicine Clinic
* Scheduled for any type of appointment
* Reports having a gun in the home

Exclusion Criteria:

* Adolescent or parent speaks/reads a language other than English or Spanish
* Adolescent has cognitive disabilities
* Adolescent resides in a group home or detention center
Impact of Promoting Community Initiated Kangaroo Mother Care (KMC) for Low Birth Weight Infants

This study is being conducted to assess the impact of promoting community initiated Kangaroo Mother Care (ciKMC) for low birth weight babies on post enrolment neonatal mortality and mortality post enrolment upto 6 months of age. This large individually randomized controlled trial will enroll 10500 low birth weight babies. The secondary objectives are examining the impact of the intervention on exclusive breast feeding and growth at 1 and 3 months, infections and hospitalizations in the neonatal period and from 1 to 5 months of age, recognition of illnesses and early care seeking from appropriate sources, motor and mental development in a subsample.

Newborns weighing \>=1500 to \<=2250gm are being enrolled into the study within 3 days of birth. Eligible babies are randomized to intervention or control arms. Mothers in the intervention arm are supported for KMC and breastfeeding by study ANM (Auxiliary Nurse Midwife) and study ASHA (Accredited Social Health Activist) like workers . Routine home visits are conducted in both intervention and control arms by government workers according to the existing government program.

Survival will be ascertained in all enrolled infants through contacts at 1, 3 and 6 months.

The data safety and monitoring committee (DSMC) conducted two interim analyses, first in September 2017 when about half of the infants had been enrolled, and second in June 2018, when almost three quarters of the enrolled babies had been followed till 28 days of age. Following the second interim analysis, the DSMC concluded that a sufficient number of infants would be enrolled by the end to September 2018 to clearly answer the study question concerning the impact of ciKMC on both neonatal and early infant mortality. The DSMC recommended that data collection be completed by the end of October 2018.


Eligibility Criteria:
Inclusion Criteria:

Low birth weight babies (≥1500 to ≤2250 g) screened within 3 days and their mothers.

* Born at home
* Singleton or twins or triplets
* Infants born in hospital, discharged and KMC not initiated in the hospital

Exclusion Criteria:

* Infant unable to feed
* Infant has breathing problem
* Infant is less active than normal
* Gross congenital malformations
* Mother does not intend to stay in the study area for the next 6 months
Bloodflow Restricted Exercise in Healthy Ageing

The overall objective of this study is to investigate the efficacy of low-intensity blood flow restricted resistance exercise (BFRRE) to promote health beneficial skeletal muscle adaptations and augment muscle function in a healthy older population. This objective will be achieved by in-dept evaluation of skeletal muscle cellular and functional characteristics prior to and after an intervention period comprising 6 weeks of BFRRE or non-exercise control intervention in healthy older subjects. A special focus is placed on the ability of BFRRE to stimulate skeletal muscle protein synthesis and augment muscle stem cell function.

Furthermore, recent findings suggests that similar exercise interventions in a population of patients with heart failure (HF) does not stimulate the desired adaptations. In accordance, we aim to compare the adaptive response to BFRRE amongst HF patients and the enrolled age-matched healthy individuals from the present investigation.

The findings of the current study will expand our understanding of how low-intensity resistance exercise alternatives might be viable in promoting muscle anabolism to combat the loss of muscle mass observed with ageing as well as the potential anabolic resistance accompanying HF diagnosis.


Eligibility Criteria:
Inclusion Criteria:

* Able to understand the written and spoken information and to give informed consent for inclusion.
* Age between 45 and 80 years
* Able to sit in a knee extension machine
* Able to deliver muscle biopsies
* Able to train 3 times per week during a 6-week period

Exclusion Criteria:

* Known history of cardiac disease
* Habitual exercise with high intensity \> 2 times pr. week within the past 6 months
* Pregnancy
* Diabetes mellitus
* Peripheral neuropathy
* Dialysis treatment
* Severe peripheral arterial disease
* Concomitant acute life threatening medical condition
* Intracranial aneurisms, arteriovenous malformation, cerebral neoplasm or abscess
* Severe arterial hypertension (≥ 180/≥ 110 mmHg) or moderate arterial hypertension (160-179/100-109) despite medical treatment
* Moderate or severe chronic obstructive pulmonary disease
* Decreased kidney function - eGFR \< 60 ml/min