cyrilzakka/clinical-trials huggingface dataset:
A Pilot Study of Rosiglitazone in the Treatment of GH Secreting Pituitary Adenomas

Growth hormone secreting pituitary adenomas(GHomas) produce excessive GH, stimulating excessive insulin like growth factor 1(IGF-1) synthesis in the liver, thus causing multiple systemic complications. The life expectancy of patients with untreated GHomas is shortened by ten years. The treatment goal of GHomas is to shrink the tumor volume and normalize GH and IGF-1. Under current treatment, only 50-70% of patients get remission. Rosiglitazone is a widely used oral antidiabetic medicine. The investigator's preliminary data showed that rosiglitazone decreased the synthesis of GH and IGF-1 in rat pituitary tumor cells GH3 and hepatocytes respectively. The investigator plan to investigate the efficacy of rosiglitazone in the treatment of patients with GHomas who have not been alleviated by other therapies.


Eligibility Criteria:
Inclusion Criteria:

* Patients with GHomas confirmed by surgery
* Patients who did not get biochemical remission: GH nadir after oral glucose tolerance test（OGTT）\>1.0ug/L or IGF-1 exceeds age matched normal range

Exclusion Criteria:

* Patients who were allergic to rosiglitazone
* Patients with liver or kidney dysfunction, respiratory failure
* Patients with heart failure
* Patients with edema
* Patients with severe hyperlipidemia
* Patients with osteoporosis or a history of non traumatic fractures
* Patients with pregnancy and lactation
* Patients who had received radiation therapy within 3 years
* Patients who had participated in other clinical trials within 3 months
* Patients with other neoplastic diseases
* Patients with mental and neurological disorders
* Patients with other conditions which were believed not appropriate to take part in the clinical trial
EIS-12656 as Single Agent and in Combination in Patients With Specified Solid Tumors

This trial investigates a new drug, EIS-12656, in participants with specified advanced solid tumors carrying pre-specified mutations. The trial consists of a dose escalation part (Phase 1) and a dose expansion part (Phase 2).

The trial is a Phase 1/2, open label, uncontrolled trial to investigate the safety and preliminary efficacy of EIS-12656 alone or in combination with a PARPi or T-DXd in patients with specified advanced or metastatic solid tumors with homologous recombination deficient (HRD) mutations.

In the Phase 1 dose escalation phase participants will receive ascending doses of EIS-12656 to evaluate the safety and tolerability and to determine an effective and safe dose for the Phase 2 part.

In the Phase 2 dose expansion phase participants will either receive EIS-12656 monotherapy at the recommended Phase 2 dose (RP2D) (Module 1) or EIS-12656 in combination with a PARPi or T-DXd (Modules 2 and 3). The objective is to evaluate the safety and tolerability and anti-tumor activity of EIS-12656 alone or in combination.

Eligibility Criteria:
Inclusion Criteria:

* Recurrent locally advanced or metastatic solid tumors
* Homologous recombination deficient mutations
* Progressed on at least on prior line of treatment or intolerant to additional effective standard therapy
* Measurable disease (RECIST 1.1 Criteria)
* Adequate organ and bone marrow function
* ECOG Performance Status 0 or 1
* Life expectancy \> 3 months

Exclusion Criteria:

* History or evidence of any clinically relevant gastrointestinal disease
* Radiation therapy within ≤2 weeks
* Significant cardiovascular disease
* Uncontrolled, active, symptomatic brain metastases
Clinical Significance of Community-acquired Respiratory Virus Infection and Longitudinal Analysis of the Lung Microbiome in Lung Transplantation

The purpose of this study is to evaluate the clinical significance of community-acquired respiratory virus (CARV) infection in patients with lung transplantation;Explore the lung microbiome dynamics within one year after lung transplantation;Find the relationship between lung microbiome and chronic lung allograft dysfunction(CLAD).

Title:Clinical Significance of Community-acquired Respiratory Virus Infection and Longitudinal Analysis of the Lung Microbiome in Lung Transplantation.

Background:Infection affects the short-term prognosis of patients with lung transplantation and chronic lung allograft dysfunction(CLAD) limits their long-term survival.It is important to provide more theoretical support for early diagnosis and treatment of acute respiratory tract infection and CLAD in patients with lung transplantation.

Study Objectives:Evaluate the clinical significance of community-acquired respiratory virus (CARV) infection in patients with lung transplantation;Explore the lung microbiome dynamics within one year after lung transplantation;Find the relationship between lung microbiome and CLAD.

Study Design:A prospective and longitudinal study,following up the patients for 3 years.

Sample Size:100 cases. Study methods:CARV detection for respiratory specimens are performed during acute infection and routine re-testing in patients after lung transplantation,following up the patients who have positive findings to analyze the progression rates to lower respiratory tract infection,mortality rate within 90 days and risk factors associated with progression and death.For HRV/CoVs/HBoV detecting positive patients, consecutively collect respiratory specimens to quantitate viral load and combine virus serology to further confirm their pathogenicity on host.Complete a longitudinal 16S ribosomal RNA and metagenomics survey of the lung microbiome on respiratory samples collected from routine testing or re-testing（pre-operation,24 hours after the operation，day 3, day 7, week 2, week 3, month 1, month 3, month 6, month 9, month 12 , month 18, month 24, month 30, month 36) to explore the lung microbiome dynamics within one year after lung transplantation and find the relationship between lung microbiome and CLAD after 3 years follow-up.Besides,collect the peripheral blood of some patients for transcriptome and/or whole genome sequencing to screen for the host susceptibility genes.

Eligibility Criteria:
Inclusion Criteria:

* 1.Patients with lung transplantation. 2.The patients who agree to participate in this study and sign informed consent.

Exclusion Criteria:

-
Patient Activated Controlled Expansion (PACE) Trial

The purpose of this study is to determine whether a patient controlled tissue expander can improve the results and patient experience in breast reconstruction. The study hypothesis is that patient controlled expansion will lead to rapid and more comfortable outcomes than historical precedents.

Title: Patient Activated Controlled Expansion (PACE) for Breast Reconstruction Utilizing Controlled CO2 Inflation

Design: Prospective, open-label, single-arm, feasibility trial Purpose: To evaluate the AirXpanders tissue expander in patients undergoing breast reconstruction surgery following mastectomy.

Enrollment: This feasibility trial will enroll up to 10 patients. Following enrollment of the first 5 patients, the sponsor will determine if additional subjects will be recruited to further evaluate treatment outcome.

Clinical Sites: Up to 3 sites and 3 surgeons will participate in this study. The surgeon(s) should have the necessary qualifications and sufficient experience (minimum of 12 breast tissue expanders placed per year) to participate in the trial.

Duration of Patient Participation: Eligible patients will be enrolled over approximately 2 months.

Patients will be instructed on the tissue expansion protocol pre-operatively and undergo post-operative clinical follow-up on a weekly basis or more frequently if deemed necessary by the treating surgeon.

Each patient will be followed through removal of the tissue expander.

Study Population:

The study population will consist of up to 10 patients. Eligible patients are females between the ages of 18 and 65 years who are planning to undergo breast reconstruction surgery following mastectomy. Eligible patients must be able to provide informed consent and understand protocol components.

Eligibility Criteria:
Inclusion Criteria:

1. Female between the ages of 18 and 65 years.
2. Planned breast reconstruction surgery post-mastectomy.
3. Able to provide informed consent.
4. Able to understand protocol components.

Exclusion Criteria:

1. Tissue at the intended expansion site is determined unsuitable by the surgeon (i.e., infection, compromised vascularity, history of compromised wound healing, mastectomy skin flaps of questionable viability, excessively tight skin envelope, previous radiation treatment, active ulceration)
2. Residual gross tumor at the intended expansion site
3. History of or planned adjuvant radiation therapy
4. Co-morbid condition determined by the surgeon to pose unduly high risk of surgical and/or postoperative complications.
5. Obesity with BMI of 30 or above
6. Current smoker
7. Psychologically unsuitable patient
8. Patient unable to understand the protocol for tissue expansion
9. Planned flight or assent to altitude exceeding 1000 meters above baseline during the expansion period.
Assessment and Rehabilitation of Cognitive Impairments in Pediatric Survivors of Cancer

This research involves assessment of cognitive outcome in childhood cancer as well as evaluation of a cognitive rehabilitation program for improving learning and problem solving difficulties in children with cancer.

The purpose of this study is to help determine specific cognitive-behavioral and neurobiologic impairments associated with chemotherapy treatments in children with cancer and to assess the efficacy of a cognitive intervention program for improving cognitive impairments in these children.

Eligibility Criteria:
INCLUSION

Everyone:

* At least 9 years of age and less than 17 years

Patients

* Diagnosis of brain tumor or acute lymphocytic leukemia (ALL)
* Completed all anti-cancer treatment(s) including chemotherapy, radiation and/or surgery

Control group

* Typical for age

EXCLUSION

Everyone:

* Non-English speaking (translated cognitive testing and MRI assessments unavailable)
* MRI contraindication, including but not limited to orthodontia, metal implants, and/or pacemaker
* Major sensory deficit disorders, including but not limited to blindness or deafness

Patients

* Shunt placement
* Received bone marrow transplant
* History of neurologic, psychiatric, developmental or major medical condition (eg, diabetes) NOT related to cancer
* Participation in any concurrent cognitive rehabilitation study

Control group

* History of neurologic, psychiatric, developmental or major medical condition (eg, diabetes)
Evaluation of Skeletal Muscle Lipid Content by Magnetic Resonance Spectroscopy

Type 2 diabetes is a growing public health issue and one component of Type 2 diabetes is 'insulin resistance" - the ability of insulin to work less well. The skeletal muscle is one of the largest users of sugar in the body, when the skeletal muscle is "insulin resistant", this contributes to diabetes. There is some evidence that the amount of fat in the skeletal muscle is related to the amount of insulin resistance. We are asking people to participate in a study to look at the amount of fat in muscle and how this fat amount changes with exercise. We hypothesize that heavier people will have higher amounts of fat and deplete this fat more slowly than lean subjects.

High intramyocellular lipid (IMCL) content in skeletal muscle has been correlated to insulin resistance in obese subjects. Yet, endurance athletes have high intramyocellular lipid content and very low insulin resistance. There are several explanations for this paradox. This study will use a new magnetic resonance imaging technique to look at the amount of fat in the muscle and its depletion with exercise. We hypothesize that overweight subjects will have higher amounts of fat and deplete this fat more slowly than lean subjects.

Eligibility Criteria:
Inclusion Criteria:

* Age range will be from age 18 to 45. We will be limiting the upper age range because increased age is associated with sarcopenia and alteration of fiber type.
* We will define the lean trained group by a BMI of \< 24 kg/m2. We will define the overweight group as BMI \> 26 25 kg/m2.
* The subjects should be participating in regular running exercise (\> 30 min/day, ≥ 5 days/week).
* Weight must be stable \[+/- 5 pounds\] for at least the three months prior to the study for all participants.

Exclusion Criteria:

* The subjects must not be on medications that may affect lipid levels, specifically lipid lowering agents, birth control pills, or diuretics.
* The subjects should not be on a high fat diet (\> 45% fat) as measured by a screening questionnaire.
* The subject must not have any contraindications to magnetic resonance imaging.
Wearable Sensors and Video Recordings to Monitor Motor Development

The objective of this study is to develop an automated, precise, quantitative assay for detecting atypical motor behavior and development in infants using data from wearable sensors and video recordings.


Eligibility Criteria:
Inclusion Criteria:

* Individuals identified as potentially at risk of abnormal motor development due to a risk factor (for example, prematurity, neonatal hypoxic ischemic encephalopathy, or neonatal stroke) OR control individuals for whom normal motor development is expected.
* Age: \< 24 months of age
* Legal guardian able and willing to give written consent and comply with study procedures.
* In case of multiple pregnancies, only one child selected at random will participate in the research activities. Study staff will have no influence over the selection, besides any known medical condition automatically excluding the baby as listed in our exclusion criteria.

Exclusion Criteria:

* Any open wound or skin breakdown on the limbs or upper torso.
* Missing or incomplete limbs (such as from amputation or congenital limb defects)
* Legal guardian unable to give written consent and comply with study procedures.
General Anesthesia Management in 15 Preterm Infant

Anesthesia management of preterm infants is challenging for the anesthesiologist. Because of rudimentary build, many medical and physical problems have shown in treatment of disease such as complications, airway problems, temperature disregulation and deficient drug metabolism. This retrospective study evaluates the perioperative management and postoperative course in premature infants undergoing diode laser photocoagulation (DLP) for retinopathy of prematurity (ROP).

Participants retrospectively investigate clinical data and anesthesia process of 15 preterm infant from anesthesia charts with ROP who underwent DLP between 2014 and 2016. This presented retrospective study was confirmed by the Institutional Clinical Research Ethics Board. Neonates burns under 30 weeks gestation and low birth weigh under 2000 g were admitted to the study. No infant were excluded from the study. Preterm infants were appreciated before surgery and informed consent was obtained form their parents. We recorded gestational age, American Society of Anesthesiologists (ASA) physical status scores, post-conceptual age, weight at birth and surgery, duration of anesthesia and surgery, blood glucose values at surgery, the management of airway, total hospital stay period, analgesia management, complications and comorbidities. Bradycardia ( \<90 beats/mean), desaturation (SpO2 \<90%) and arrhythmia were recorded. Electrocardiography (ECG), pulse oximetric saturation (SpO2), end-tidal carbon dioxide pressure, heart rate (HR) and body temperature were monitored in operating room. Topical 0.5% proparacaine eye drops were administered to all infants routinely. Anesthesia was induced with thiopental 6 mg kg-1 and fentanyl 1 µg kg-1 and it was maintained with 50% oxygen 50% air 1%-3% sevoflurane in all cases. Inhaled anesthetic agent was not preferred for induction of anesthesia because of causing hypotension. The premature infants were intubated by same experienced anesthesiologist. In all infants, were intubated the patients without muscle relaxant under spontaneous ventilation. Perioperative complications, blood glucose value, devices in airway management and extubation value were recorded. After surgery, extubation was performed when spontanea ventilation was enough and extubation was recorded. All infants were taken to newborn intensive care unit (NICU). Data are reported as mean ± standard deviation and percentage(%).

Eligibility Criteria:
Inclusion Criteria:

* all preterm infants who was decided to apply ROP

Exclusion Criteria:

* No patient was excluded
CMR Imaging of Autoimmune Diseases

Myocarditis is an important clinical problem which can can occur as a result of viral infections and autoimmune rheumatic diseases. Cardiac MRI is an important non-invasive means of making a diagnosis. However, current MRI techniques have significant limitations. Firstly, in order to create high-quality pictures, patients are required to hold their breath several times for multiple lengths of time. They often struggle with this due to underlying heart/lung problems. This can adversely affect the overall quality and image interpretation. Secondly, current techniques create 2D images that are potentially underestimating the presence and severity of any tissue inflammation/ injury. This may result in inappropriate treatment, particularly for patients with underlying autoimmune systemic disease who require immunosuppression.

Diagnosis by MRI rests on detecting tissue injury through T2 and T1-weighted sequences which detect tissue inflammation and tissue injury. The purpose of this study is to evaluate the diagnostic accuracy of novel 3D free-breathing sequences for T2-weighted and fibrosis/ LGE imaging.

Patients with suspected isolated myocarditis (viral/idiopathic) or myocarditis as part of an autoimmune systemic disease will be recruited to ensure that the novel techniques are tested in a broad spectrum of patients with inflammatory heart muscle disease.


Eligibility Criteria:
Inclusion Criteria:

* All patients referred for CMR for clinically suspected myocarditis either idiopathic or in the context of autoimmune rheumatic disease.
* Patients who are able to give informed consent.

Exclusion Criteria:

* Patients in atrial fibrillation.
* Patients who are unable to give informed consent.
* Patients whose physical or mental condition indicates that the additional time in the CMR scanner should be minimised.
* Patients who cannot have CMR due to either contraindications to CMR (e.g., non-conditional intracardiac devices) or contraindications to contrast (e.g., history of allergy to gadolinium).
Study on the Safety of Neladenoson Bialanate, How it is Tolerated and the Way the Body Absorbs, Distributes and Gets Rid of the Study Dug Given as a Single Oral Dose in Participants With Liver Impairment and Healthy Participants Matched for Age-, Gender-, and Weight

Neladenoson bialanate is currently under clinical development for a condition in which the heart has trouble pumping blood through the body (chronic heart failure). Liver impairment is a condition in which the liver is not working as well as they should. The goal of the study is to learn more about the safety of neladenoson bialanate, how it is tolerated and the way the body absorbs, distributes and excretes the study dug given as a single oral dose neladenoson bialanate in participants with liver impairment and healthy participants matched for age-, gender-, and weight


Eligibility Criteria:
Inclusion Criteria:

All subjects

* Male and female Caucasian subjects between 18 and 79 years of age (both inclusive) with a body mass index above/equal 18.0 and below/equal 34.0 kg/m² Subjects with hepatic impairment
* Subjects with documented liver cirrhosis confirmed by histopathology, e.g., previous liver biopsy, laparoscopy, ultrasound, or fibroscan
* Subjects with hepatic impairment as per Child Pugh system
* Subjects with stable liver disease during the last 2 months Healthy subjects
* Healthy subjects with mean age and body weight not varying by more than ±10 years and ±10 kg from the groups of subjects with mild and moderate hepatic impairment, respectively.

Exclusion Criteria:

* Medical history of continent ileostomy.
* Febrile illness within 1 week prior to admission to study center.
* Known hypersensitivity to the study drug (active substances or excipients of the preparation).
* Subjects with diagnosed malignancy within the past 5 years.
* Use of any systemic or topical medicine or substances which oppose the study objectives or which might influence them, in particular:

Starting from screening on, but minimum from 2 weeks before the study drug administration until the follow-up visit:

* CYP3A4 inducers
* CYP3A4 inhibitors
* Potent CYP2C8 inhibitors
* Major uridine diphosphate-glucuronosyltransferase isoenzyme 1A1 (UGT1A1) substrate (irinotecan)

On the day of administration of neladenoson bialanate:

* Major breast cancer resistance protein (BCRP) substrates
* Regular daily consumption of more than 500 mL of usual beer or the equivalent quantity of of more than 2 units of alcohol in another form - Intake of ethanol containing food and beverages from 48 h prior to admission to the study center until 96 h after study drug administration, afterwards not more than 2 units of alcohol per day until follow-up examination.
* Intake of food and beverages containing grapefruit or pomelo from 14 days prior to study drug administration up to the last time point of PK sampling.
* Therapies (e.g. physiotherapy, acupuncture, etc.) within 1 week before study drug administration.
* Positive urine drug screening.
* Positive results for human immune deficiency - Abnormal (clinically significant) thyroid stimulating hormone (TSH).
Study Evaluating Intravitreal hI-con1™ in Patients With Choroidal Neovascularization Secondary to Age-related Macular Degeneration

The purpose of this study is to evaluate the safety, biological activity and pharmacodynamic effect of repeated intravitreal doses of hI-con1 0.3 mg administered as monotherapy and in combination with ranibizumab 0.5 mg compared to ranibizumab 0.5 mg monotherapy in treating patients with choroidal neovascularization (CNV) secondary to age-related macular degeneration (AMD).


Eligibility Criteria:
Inclusion Criteria:

* Males or females of any race at least 50 years of age
* Active primary Choroidal Neovascularization (CNV) secondary to Age-Related Macular Degeneration (AMD) in the study eye
* Best Corrected Visual Acuity (BCVA) of 70 to 24 letters (worse than 20/40 up to 20/320) in the study eye

Exclusion Criteria:

* Monocular patient or patient with a BCVA of 35 or fewer letters (20/200 or worse) in the better seeing eye
* Any prior treatment of CNV or advanced AMD in the study eye, except for dietary supplements or vitamins
* Any intraocular or ocular surface surgery (including cataract surgery and laser procedures) in the study eye within 3 months
* Vitrectomy in the study eye
* Hereditary or chronic hemorrhagic or coagulopathy conditions (i.e., hemophilia)