cyrilzakka/clinical-trials huggingface dataset:
Co-administration Study in Patients With Elevated Cholesterol and Coronary Heart Disease (0653-803)

The purpose of this study is to investigate additional cholesterol lowering effects in patients with coronary heart disease by giving an investigational drug with a patient's current approved cholesterol lowering medication.

The duration of treatment is 10 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Patients with elevated cholesterol and coronary heart disease

Exclusion Criteria:

* Patients who have cholesterol levels within normal ranges as identified by the study
A Double-Blind Study to Evaluate the Safety and Pharmacokinetics of L-Ofloxacin (RWJ 25213) in Subjects With HIV Infection

To determine the safety and pharmacokinetics of L-ofloxacin (RWJ 25213) in patients with HIV infection.


Eligibility Criteria:
Inclusion Criteria

Patients must have the following:

HIV infection.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms or conditions are excluded:

* Active opportunistic infection or neoplasm.
* High likelihood of death during study.
* Significant ophthalmologic, renal, hepatic, cardiovascular, hematologic, neurologic, psychiatric,respiratory, or metabolic disease.
* Donation of \> 1 unit blood or acute loss of blood within one month of study entry.

Patients with the following prior conditions are excluded:

* History of opportunistic infection.
* Previous allergic reaction to ciprofloxacin, norfloxacin, or any other quinolone.

Prior Medication:

Excluded:

Use of any investigational agent within 7 days of entry into study. Use of any medication within 3 days prior to entry (7 days for AZT). Alcohol or drug abuse.
Radium-223 Dichloride Asian Population Study in the Treatment of CRPC Patients With Bone Metastasis

To evaluate the safety and efficacy (Overall survival \[OS\]) of multiple doses of Ra-223 dichloride in an Asian population of subjects with CRPC metastatic to the bone.


Eligibility Criteria:
Inclusion Criteria:

* Histologically or cytologically confirmed adenocarcinoma of the prostate
* Patients diagnosed with progressive bone predominant metastatic Castration-Resistant Prostate Cancer (CRPC) /Hormone Refractory Prostate Cancer (HRPC) with at least 2 skeletal metastases on imaging with no lung, liver, and/or brain metastasis (lymph node only metastasis is allowed)
* Known hormone refractory disease
* No intention to use cytotoxic chemotherapy within the next 6 months
* Either regular (not occasional) analgesic medication use for cancer related bone pain or treatment with external bean radiation therapy (EBRT) for bone pain within previous 12 weeks
* Age \>/= 18 years
* Race is Asian
* Eastern Co-operative Oncology Group (ECOG) Performance Status (PS): 0-2
* Life expectancy \>/= 6 months
* Adequate bone marrow, liver and renal function as assessed by the Laboratory required by protocol

Exclusion Criteria:

* Treatment with an investigational drug within previous 4 weeks prior to screening, or planned during the treatment or follow-up periods
* Eligible for docetaxel treatment, i.e. subjects who are fit enough, willing and who are located where treatment with docetaxel is available
* Treatment with cytotoxic chemotherapy within previous 4 weeks prior to screening, or failure to recover from adverse events due to cytotoxic chemotherapy administered more than 4 weeks prior to screening (however ongoing neuropathy is permitted)
* Prior hemibody external radiotherapy is excluded. Subjects who received other types of prior external radiotherapy are allowed provided that the bone marrow function is assessed and meets the protocol requirements for hemoglobin, absolute neutrophil count and platelets.
* Received systemic therapy radionuclides (e.g., strontium-89, samarium-153, rhenium-186, rhenium-188, or radium-223 dichloride) for the treatment of bony metastases
* Blood transfusion or erythropoetin stimulating agents within the previous 4 weeks prior to screening
* Other malignancy treated within the last 3 years (except non-melanoma skin cancer or low-grade superficial bladder cancer)
* Visceral metastases as assessed by abdominal/pelvic computed tomography (CT) or other imaging modality
* Presence of brain metastases
* Lymphadenopathy exceeding 3 cm in short-axis diameter
* Any size pelvic lymphadenopathy if it is thought to be a contributor to concurrent hydronephrosis
* Imminent or established spinal cord compression based on clinical findings and/or magnetic resonance imaging (MRI). Subjects with history of spinal cord compression should have completely recovered.
* Received local practice implant therapy containing lodine-125 or Palladium-103 for the primary lesion of prostate cancer within the 6 months prior to screening.
* Any other serious illness or medical condition
The Effect of Reflexology in Patients With Viral Bronchiolitis

To test the influence of reflexology on bronchiolitis.

Reflexology has been used in different respiratory tract infections on pulmonary function tests in patients with asthma, with some success. It has also been tested in newborns with respiratory distress syndrome, where it has decreased respiratory rate. Whole body massage was found to be helpful in newborns with opioid withdrawal syndrome. It has been shown to be a safe treatment and well tolerated even among very young infants.

Therefore, the investigators decided to evaluate effect of reflexology treatment in patients with viral bronchiolitis.

Eligibility Criteria:
Inclusion Criteria:

* All children admitted due to bronchiolitis

Exclusion Criteria:

* Children whose parents refused participation
Qualitative Study of Suicidal Recrudescence Among Adolescents in November 2021

A qualitative study, combining psychiatric and anthropological perspectives, focused on the lived experiences of patients who had recourse to HPNCL emergencies during the period of November 2021, as well as the experiences and perceptions of those around them - such as their family, teachers or school and nursing staff. This multi-site approach will provide a multidimensional perspective on the experience of individuals and those around them, as well as a triangulation of data.

The hypotheses to explain the increase in the rate of suicidal crisis will be addressed through semi-structured interviews proposed to the participants of the study.

Interviews in the presence of two members of the research team (child psychiatrists, psychologists, anthropologists, etc.) will be offered to participants. These interviews will be face-to-face when possible, but can also be done remotely, by teleconsultation, depending on the preferences of the participants.

These interviews will be based on a questionnaire established beforehand evoking the history of mental disorders and the experience of the participant in the study and his entourage of the Covid-19 health crisis.

All information exchanged during these interviews will be made anonymous (data collected and processed as well as the results presented). They will be used exclusively in the context of the study and not communicated to the medical team involved in the patient's care.

The proposed interviews will be carried out separately with:

* The patient who consulted the emergency room during the month of November 2021
* The parent(s) of the study participant
* One or more health professionals taking care of the patient
* The school attended by the patient who will be questioned about the suicidal problem and Covid-19 in general or not about the patient in particular.
* Child welfare professionals (ASE) potentially involved in the care of the study participant.

Questionnaires will also be carried out with patients in order to complete the assessment of their clinical condition at a distance from the psychological crisis:

Eligibility Criteria:
Inclusion Criteria:

* Any patient having consulted in the child psychiatric emergency room of the HPNCL between November 1, 2021 and November 30, 2021 for suicidal thoughts.
* Age between 13 years and 17 years and 11 months
* Good understanding of written and oral French
* Collection of the informed consent of the patient and of one of the two parents or holder of parental authority

Exclusion Criteria:

* Inability to comply with the instructions defined and exposed during inclusion
* Refusal of participation by the patient or one of the legal guardians
Treatment Schistosomal Portal Hypertension: Efficacy of Endoscopy or Surgery

Upper gastrointestinal bleeding (UGIB) is a major cause of morbidity and mortality in patients with portal hypertension secondary to schistosomiasis mansoni. Taking into account the endemic nature of schistosomiasis mansoni in our region and the high morbidity and mortality directly associated with rupture of esophageal varices and UGIB in affected patients, we conducted a prospective randomized trial in patients with schistosomiasis and a history of bleeding esophageal varices. Its purpose was to assess the efficacy of endoscopic treatment alone compared with the efficacy of sclerotherapy preceded by a surgical treatment: Esophagogastric devascularization with splenectomy (EGDS).

This was a prospective, randomized, single-center study carried out at the Department of Clinical and Surgical Gastroenterology of Hospital Universitário Professor Alberto Antunes, Universidade Federal de Alagoas (HU/UFAL). It was approved by the local Research Ethics Committee (protocol #98/0039-3, code 4010000-6) and all patients provided written informed consent prior to study enrollment. Patients who met relative criteria for exclusion received the current standard of care and follow-up and were analyzed as a third group in the study.

Over a two-year period, 79 patients were recruited for elective treatment of SPH. The criteria for selection were: a) an established diagnosis of hepatosplenic schistosomiasis as the cause of portal hypertension; b) a history of UGIB secondary to rupture of esophageal varices, with at least 20 days having elapsed since the most recent episode of bleeding; and c) age between 15 and 65 years.

The exclusion criteria were: chronic alcoholism, defined as an alcohol intake of ≥60 g/EtOH/day in men and ≥40 g/EtOH/day in women; evidence of decompensated liver disease of mixed etiology or of any chronic disease that contraindicated surgery were considered absolute exclusion criteria; the relative criteria for exclusion were altered hemostasis (platelet count \< 50×109/L or INR \> 1.5); presence of fundal varices on endoscopy.

Eligibility Criteria:
Inclusion Criteria:

* age between 15 and 65 years;
* an established diagnosis of hepatosplenic schistosomiasis as the cause of portal hypertension;
* a history of UGIB secondary to rupture of esophageal varices, with at least 20 days having elapsed since the most recent episode of bleeding.

Exclusion Criteria:

* Chronic alcoholism, defined as an alcohol intake of ≥60 g/EtOH/day in men and ≥40 g/EtOH/day in women;
* evidence of decompensated liver disease of mixed etiology or of any chronic disease that contraindicated surgery were considered absolute exclusion criteria;
* the relative criteria for exclusion were altered hemostasis (platelet count \< 50×109/L or INR \> 1.5);
* presence of fundal varices on endoscopy.
Exercise Training on Gait Pattern in Pregnancy

The research will be conducted with healthy pregnant women who applied to the Ege University Gynecology and Obstetrics Department Polyclinic, and were referred to the Sports Medicine Department.The study will consist of two groups as the control group and the exercise group.Voluntary pregnant women who are not found to be inconvenient to do moderate-intensity exercise by the doctor will participate in the study.The study was planned as a randomized controlled and single-blind study.The participant's demographic information, obstetric assessment, physical activity level, fall history and pain assessment will be recorded.Foot plantar pressure, static and dynamic balance, center of pressure (COP), subtalar joint evaluation and gait evaluation will be measured by pedobarography at Ege University Orthopedics and Traumatology Department Gait Laboratory.The control group will be offered walking as recommended by ACOG for pregnant women.Clinical exercise training will be given to pregnant women in the study group by a specialist physiotherapist.

Pregnancy is a condition that includes many parameters.As the gestational week progresses and the fetus grows, changes are observed in the musculoskeletal system, hormonal system and other systems of the mother's body.Mechanical pain is observed in pregnant women with the expansion of the pelvis and the increase in the load on the lower extremities.The American Society of Obstetrics and Gynecology (ACOG) recommends physical activity and moderate-intensity exercises for a healthy pregnancy and delivery in pregnant women.Foot plantar pressure measurement is accepted in the literature as an objective measurement method in lower extremity biomechanical pain, static and dynamic balance.Evaluations will be made on day 0 and the day corresponding to the end of the 8th week.

Eligibility Criteria:
Inclusion Criteria:

* Being between the ages of 18-40
* No risk of pregnancy-related complications
* Between 12th and 24th weeks of pregnancy

Exclusion Criteria:

* History of lower extremity, pelvis or spine surgery
* Pain in the lower extremity, pelvis, and spine that persists for more than 6 months
* Any developmental delay related to the fetus
Auricular Acupuncture for Exam Anxiety in Medical Students

Title of the study: Auricular acupuncture (AA) for pre-exam anxiety: A blinded randomized crossover study on healthy volunteers

Study period: 04/2012 - 07/2012

Institution: Department of Anesthesiology and Intensive Care Medicine University Medicine of Greifswald

Aim of the study: To investigate the anxiolytic effect of auricular acupuncture (AA) in comparison to placebo acupuncture and no intervention during oral exams in anatomy at the University of Greifswald

Design: Prospective blinded randomized crossover trial

Intervention:

1. AA using indwelling fixed needles, retained 24 h in situ
2. AA using placebo needles

Number of volunteers: N = 40

Outcome measures: Anxiety level, Heart rate, blood pressure.


Eligibility Criteria:
Inclusion Criteria:

1. Medical students at the University of Greifswald
2. Going to take part in oral exams of human anatomy
3. Participants without previous anxiolytic medication
4. Participants without any experiences with acupuncture
5. Patients who have given written informed consent

Exclusion Criteria:

1. Local auricular skin infection
2. Pregnant or lactating women
3. Participants with prosthetic or damaged cardiac valves, intracardiac and intravascular shunts, hypertrophic cardiomyopathy and mitral valve prolapse (risk of bacterial endocarditis according to guidelines of AHA)
4. Participants who are unable to understand the consent form
5. History of psychiatric disease, alcohol and drug abuse
Cognitive Intervention With Go and Chess in Early and Subjective Cognitive Decline

The goal of this clinical trial\]is to evaluate if learning to play traditional board games could improve cognition in subjects with mild cognitive impairment and subjective cognitive decline. The main questions it aims to answer are:

* Do Go and Chess improve cognition?
* Is a game better than the other? Is the effect of both games on cognition synergistic?
* Do Go and Chess improve quality of life?
* Do Go and Chess improve mood?
* Do Go and Chess improve lifestyle?

Participants will be randomized to one of four groups:

* Group intervention with Go, once a week, for 12 weeks
* Group intervention with Chess, once a week, for 12 weeks
* Group intervention with Go and Chess, twice a week, for 12 weeks
* Control group


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of mild cognitive impairment or subjective cognitive decline
* Willingness to participate in the board games classes
* Living within 20-minute driving distance from the center
* Signed informed consent

Exclusion Criteria:

* Prior knowledge of the the game rules (in case the subject knows one of the two, they can be randomized to the other one)
* Significant linguistic or sensory impairment (according to clinical judgment)
* Significant behavioral or psychiatric disturbances (according to clinical judgment)
* Significant medical comorbidities (according to clinical judgment)
Increasing the Yield of Blood Cultures in Neonates

The purpose of this study is to determine whether the use of a single blood sample of 1cc in an aerobic bottle will provide a better yield and time to positivity than 2 samples of 0.5 cc in 2 (aerobic and anaerobic) bottles for blood cultures in neonates.


Eligibility Criteria:
Inclusion Criteria:

* All blood cultures taken in the NICU during the study period.

Exclusion Criteria:

* Bacteria that are normal flora of the skin such as Coagulase negative staphylococci or Streptococci Viridans are considered, except if grown in two sets of cultures or in the presence of laboratory and clinical indices of infection.
Interest of the OSA (Obstructive Sleep Apnea) Predictive Scores in the Prognosis of Postoperative Mortality of Femoral Neck Fractures

Interest of the four major OSA Predictive Scores (STOP-BANG, P-SAP, DES-OSA, OSA50) in the prognosis of postoperative mortality after femoral neck fracture.

* All patients incoming at the Saint-Luc Bouge Hospital with a femoral neck fracture
* Study between 15/09/2014 and 15/10/2015
* The four OSA predictive scores will be collected
* Evaluation of mortality at 1 month

Eligibility Criteria:
Inclusion Criteria:

* All patients with femoral neck fractures
* Incoming at the Saint-Luc Bouge Hospital
* Between 15/09/2014 and 15/10/2015

Exclusion Criteria:

* None
A Phase II Study of DMP 115 to Assess Focal Liver Lesions

To determine the optimal dose of DMP 115 to image liver lesions and to assess whether contrast can improve the detection of focal liver lesions.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with 1 but \<7 focal liver lesions
* Scheduled for liver biopsy within 30 days of study
* Scheduled for CT or MR within 30 days of study

Exclusion Criteria:

* Critically ill subjects
* Subjects with right-to-left shunts
NeuroCovid - a Study of Intensive Care-requiring Covid-19 Patients

Critically ill patients requiring intensive care suffer to a large extent from cognitive deficits involving higher brain functions that primarily affect memory, learning and the ability to concentrate. While the background to this effect is not fully understood, there are growing evidence to support mechanisms related to neuro inflammation and changes in blood flow with concomitant ischemic brain damage. Patients with covid-19 often suffer from severe inflammatory activity with an increased risk of coagulation abnormalities and brain damage. Covid-19 patients requiring intensive care develope more severe impairment of neurological and cognitive function than critically ill intensive care patients who have not covid-19. This project therefore aims to map the link between inflammation, immunology and coagulation systems as well as biochemical and structural changes in the brain with cognitive effects in patients in intensive care for covid-19.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 years
* Need for Intensive care
* Positive PCR test for SARS-CoV-2

Exclusion Criteria:

* None
Comparison Between Two Tissue Acquisition Techniques by Endoscopic Ultrasound. (EUS)

There are various techniques to obtain tissue samples by using fine needle guided by endoscopic ultrasound (EUS). These techniques attempt to obtain the most adequate material with the best quantity and quality for analysis. Currently studies that compare the results concerning capillary technique versus wet technique are not available. In this sense, the authors consider necessary to explore both techniques documenting the results that can define which could be the best method so that it can routinely be used in cases of digestive neoplasia.

The aim of the study will be compare both techniques guided by endoscopic ultrasound (Capillarity versus Wet) and identify which obtains the best sample quality for histopathology analysis as tissue acquisition method in patients diagnosed with tumors of pancreas, biliary tract, liver or lymph nodes.

The researchers are planning a prospective, pilot study in 30 subjects. All patients will be submitted to both techniques of tissue acquisition (capillarity versus wet) in the same procedure of endoscopic ultrasound. Obtained samples for histopathology analysis will be submitted to a blind examination by two different pathologists.

Eligibility Criteria:
Inclusion Criteria:

* Low or moderate suspicious of malignancy lesion in pancreas, liver or metastatic lymph nodes
* Initial diagnosis according to the characterization by endoscopic ultrasound

Exclusion Criteria:

* Bleeding
* Complications during biopsy procedure
* Needed to use procedures other than those contemplated in the study.
* Patients who not require endoscopic ultrasound evaluation
* Patients who not accept the procedures of the study
Sildenafil Citrate for the Management of Asymmetrical Intrauterine Growth Restriction

Intrauterine growth restriction (IUGR) is defined as fetal abdominal circumference (AC) or estimated fetal weight (EFW) \< 10th centile. In asymmetrical IUGR the parameter classically affected is the abdominal circumference (AC). Fetal growth restriction (FGR) complicates approximately 0.4% of pregnancies and severely increases the risk of perinatal morbidity and mortality. This is particularly due to premature delivery, both for fetal and for secondary maternal indications such as the development of pre-eclampsia.

Consequence of deficient uteroplacental blood flow, including IUGR, pre-eclampsia, and placental abruption have been implicated in more than 50% of iatrogenic premature births. For this reason, the problem of severe IUGR forms a substantial portion of the population that tertiary care centres care for.

The effect of early-onset IUGR is particularly significant: of those born alive, less than a third will survive their neonatal intensive care unit (NICU) stay without significant neurodevelopmental sequelae. Survival rates for severely growth-restricted fetuses very remote from term (\<28 weeks' gestation) vary from 7% to 33%.

As these early-onset IUGR children are born very preterm, there are significant risks of neonatal mortality, major and minor morbidity, and long-term health sequelae.

The use of ultrasound Doppler waveform analysis in pregnancies complicated by IUGR suggests compromised uteroplacental circulation and placental hypoperfusion. Currently there are no specific evidence-based therapies for placental insufficiency and severe IUGR. Non-specific interventions include primarily lifestyle modifications, such as reducing or stopping work, stopping aerobic exercise, rest at home, and hospital admission for rest and surveillance. These interventions, which are not supported by evidence from randomized trials, are used in the belief that rest will enhance the uteroplacental circulation at the expense of that to the glutei and quadriceps muscles.

There is evidence from ex vivo and animal models of growth restriction that the phosphodiesterase 5 inhibitor sildenafil citrate increases average birth weight and improves uteroplacental blood flow (umbilical artery, uterine artery).


Eligibility Criteria:
Inclusion Criteria:

* Pregnant Women ≥ 28 wk
* Diagnosed as asymmetrical Intrauterine growth restriction

Exclusion Criteria:

* Severe preeclampsia
* Fetus with reversed umbilical artery end diastolic flow.
* Symmetrical Intrauterine growth restriction
* Diagnosed to have congenital anomalies.
* Diabetes mellitus with pregnancy.
* Patients with contraindication for the drugs given as gastric or duodenal ulcer,
* Twins pregnancy.
* Patients on antihypertensive or rheumatic heart disease
* Smokers.